ML20137Q596
| ML20137Q596 | |
| Person / Time | |
|---|---|
| Issue date: | 09/06/1985 |
| From: | NRC |
| To: | |
| Shared Package | |
| ML20136D915 | List:
|
| References | |
| FRN-50FR30616, RULE-PR-35 AA73-1, NUDOCS 8509230078 | |
| Download: ML20137Q596 (210) | |
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Federal Register Notices that pertain to NRC's regulation of byproduct ) material for medical use f January 11,1956--Part 30, Radioisotope Distribution, published final to comply 1 with the Atomic Energy Act of 1954 February 12,1959--Part 30 amended for general licensed devices final January 18,1962--Part 30 proposed amendment for physician's general license June 6,1964--Part 30 amendment.re-proposed for physician's general license July 14,1964--No export to Cuba May 13,1965--Part 30 amended final for physician's general license June 26,1965--Part 30 broken in Parts 30 through 36 final October 5,1966--CP that proposed two diagnostic groups October 14,1967--Two groups established final August 10,1968--Proposed amendment to Part 30 re exemption of small quantities April 9,1970--Tc for thyroid scans added to Group II April 22,1970--Final re exempt quantities July 17,1970--Change in authority citation March 5,1971--Tc for blood pool added to Group II January 11,1973--AEC reorganized; nomenclature changes needed March 9,1973--Proposed changes to Part 35 re title, physician responsibilities, delegable chores, training for staff, misadministration reporting August 17,1973--conforming amendments re publication of new Part 19 January 21,1974--Grosp III-generators and kits, Group IV-therapy pharmaceuticals, and Group V-devices proposed July 173 .1974--Groups I through VI created final January 20,1975--new clinical procedures added March 3,1975--nomenclature changes necessitated by split of AEC into NRC and ERDA March 3,1975--Part 21, " Reports of Defects and Noncompliance" proposed May 8,1975--Part 21 comment period extended June 25,1975--I seeds added to group VI February 23,1976--add Sn/In generator to Group III April 19,1976--address changes April 19, 1976--Ybl69 DTPA added to Group II i August 16,1976--Il25 Fibrinogen added to Group II December 27,1976--Sulfur ' colloid kit added to Group III March 3,1977--Proposed require hospital, not MD, to hold license 1 8509230078 850906 PDR PR 35 50FR30616 PDR
March 31, 1977--add In113m chloride to Group II, pyrophosphate to Group III May 19,1977--GA0 reporting and recordkeeping approval May 19, 1977--Proposed reg: qualified expert calibrate teletherapy units, monthly spot checks, report therapeutic misadministrations July 14,1977--extend comment period re May 19, 1977 July 14,1977--Final requiring hospitals to hold license
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June 6. '1977--Final Part 21, Reporting of Defects and Noncomp1'iance July 7,1977--Part 21 typo's and change of effective date March 17,1978--Proposed minor relief from package insert instructions, update chemical forms in groups February 7, 1978--add medronate sodium to Group III January 16,1978--add human serum albumin to Group III March 17, 1978--Proposed policy statement June 16,1978--add gluceptate to Group III June 28,1978--Proposed count and survey of brachytherapy patients
' July 7,1978--Proposed misadministration reporting.
August 23,1978--Form 313M replaces Form AEC 313 September 7, 1978--Add microspheres to Group III Octobe- 18,1978--GA0 approves Form 313M November 28,1978--Final count brachytherapy sources and survey patient January 8,1979--Final calibrate teletherapy units and do monthly spot checks February 20,1979--Final re March 17, 1978 March 2,1979--GA0 approval of January 8,1971 April 9,1979--Proposed re Radiation Safety Committee May 14,1980--Final misadministration requirements: keep records, promptly report therapy cases, quarterly report diagnostics June 12,1980--typos .re May 14, 1980 June 19,1980--Final Mo99 breakthrough test March 6, 1981--add oxidronate sodium to Group III March 26,1981--Notice to retain 1131 for cardiac dysfunction September 1,1981--Proposed measure dosages March 26,1982--add disofenin to Group III April 13,1982--Proposed pentetate aerosol for lung . function April 28,1982--Proposed teletherapy room monitor and service units June 29, 1982--add succimer to Group III September 12,1982--Final re April ' 9,1979 January 18,1983--Final re April 28, 1982 February 4,1983--Final re April 13, 1982
February 28,1983--typos re February 4,1983 March 30, 1983--Prop'osed add lixiscope to Group VI June 28,1983--Final re March 30, 1983 May 9, 1984--Add OMB control numbers to recordkeeping and reporting requirements July 9,1984--Form NRC 313 replaces Form NRC 313M April 22,1985--Proposed new uses of approved drug's a Y 4 i I i
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.. UNITED j\ , Washington, Wednesday, January 11, 1956 TITLE 10--ATOMIC ENERGY . 3,,,
2 e Chapter I-Atomic Energy so.s Persons operating commi== ton-owned fac111tles.
, Commission soft carriers. t
' 30.s other exemptions.
PAar 30-LicEns1xc or Brrmancer hfArEalAL CENEmar. MCENsES-arrWCAMoNs rom UCEN&Es This amendment to Title 10 CFR, Part 30.20 '2ypes of licenses.
; I' 33. Radioisotope Distribution, is pub. 30.21 General licenses.
,- lished for the purpose of bringing it into 30.22 Appucanons for sputac iteenses. - .
O conformity with the Atomic Energy Act a m oener ,eea$c " e cf 1954 (E8 Stat. 919) and to establish 30.24 special requirements for tasuance of
- j. a simplified and less restrictive procedure
- spectac Iscenses.
; relat!ng to the export of byproduct ma-terial. In addition, changes have been "#*"'*'
incorporated in il 30.71 and 30.72 to . 30 31 Issuance of spectne licenses for use of f permit the distribution of certain addl. byproduct material. jP I tjonal types of sealed sources and quan ,3032 Terms and conditions of 11eenses. l> , ,p G:Jes and types of byproduct material product mateetal. Erptra lo .
' 10 persons who do not hold specific
- 3035 Renewal of license.
LCensts. 30.36 Amendment of licenses at request of i Except as required to accomplish the neensee. fere;,oing purposes, the changes effected 30.37 commission acuan on applications to by this revision are designed to simplify nnew of amend. ar.d clanfy pr6 visions of the existing 30.38 Inanenability of neenses. regulations and not to effect substantial 3G Pers na possessig bypro@ct matnial changes in the Commission's procedurcsj' and requirements relating to the licens-
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I i Mg cf byproduct material. In light of arcoans, arroars aNo rNsrecrrons these considerations, the Atomic Energy 30.41 m eds. Ccmmission has found that general no. 30.42 Repoits of exports. tice of proposed rule-making and pub. 30 43 Inspecuon. Lc procedure thereon are unnecessary 30.44 Tests. and would be contrary to the public wontricarron ann mEvocanoN or ucsNsts tn'erest. The Commission has under considera- 30.61 Modiacation and revocation of 11 tion further amendments to Part 30 30.62 R1YbYt$ withhold or recall byproduct thich will be published in accordance matertal. . eth procedures designed to afford the ' customary opportunity for public par- * * # '#" *** ticipation. 30.61 Violations. All interested persons who desire to scurntruz sutuut written comments and sugges- ! t 1:cns relating to the following amend- b u1 ^N. cant should send them to the U. S. k I
" Atomic Energy Commission. Washington Atrrmarry: ei 30.1 to 30.72 issued under i
- 25. D. C., Attention of the Director, su.161. 68 stat. s48. 42 U. s. c. 2201. Inter. j D.tsion of Civilian Application ~ pret or apply an*cs 81, 82,182.183. 68 Stat.
Ef'ective thirty days after publication 935. 953. 954. 42 L S. C. 2111. 2112, 2232 2233. For the purpos.s of see. 223. c8 stat.
, !n the PEDERAL Rtc1 sten, Part 30, Title 958142 U. s. c. 2273, 6130.21 (b) and 30.32 10 CFR, Radioisotope Distribution (c) issued under sec.161b. 68 stat. 948; 42 Rrgulationis hereby amended to read U. s. c. 2201 (b) and il 30A1. 30 42 and 30 43 .
g3 gny;ogg. lasued under sec.101p. 68 Stat. 950, 42 U. 8. c. 2201p. crNamAL ruovrarons cENEaAL raoV151oNS 311 Purpose. I 30.1 Purpose. The regulations in s sc 2 secpe-
*- this part are promulgated by the Atomic
$ $'[o Q 'n's"A" Energy Commission, pursuant to the 33 s Interpretauons. '
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sl y 7 Atomic Energy Act of 1954 (68 Stat,919), government or nation or any political } j subdivision of x.., d government er { 'g to provide for the. licensing of byproduct nation, or other entity; and (2) any legal - ' material. successor, representative, agent,' cr i 30.2 Scope. Except as provided in agency of the foregoing; ; II 30.6 to 30.8, the regulations in this part (1) " Physician" means an individual ? apply to all persons in the United States. licensed by a state or territory of the d United States, the District of Columb!2 - i 30.3 License requirements. No or the Commonwealth of Puerto Rico to person subject to the regulations in this dispense drugs in the practice of med!- part shall manufacture, produce, trans* cine;
- fer, receive, acquire, own, possess, use. (j) " Production facility" means pro. -@
import or export byproduct material ex- duction facility as defined in the regula. - cept as authorized in a specific or gen- tions contained in Part 50 of this ' eral license issued pursuant to the chapter; regulations in this part. *(k) "R e a e a r c h and development * < means (1) theoretical analysis, explora- .I I 30.4 Dc/iniffons. As used in this tion, or experimentation; or (2) the ex-part: tension of investigative findings and 'i (a) "Act" means the Atomic Energy theories of a scientific or technical na- , Act of 1954, including any amendments ture into practical application for ex-thereto; perimental and demonstration purposes, including the experimental production (b) " Byproduct material" means ary radioactive material (except special nu. and testing of models, devices, equip-clear material) yielded in or made ment, materials and processes. *h ~ radioactive by exposure to the radiation search and development" as used in this ' incident to the process of producing or part does not include the internal or 5 utilizing special nuclear material; external administration of byproduct (c) " Commission" means the Atomic material, or the radiation therefrom, to y Energy Commission and its duly author. human beings; } l ized representatives; (1) " Sealed source" means any by- . q (d) " Curie" means that amount of product material that is encased in, and radioactive material which disinte. is to be used in, a container in a manner
. 4 grates at the rate of 37 billion atoms per second; intended to prevent leakage of the ,g (e) " Human use" means the internal byproduct material; ;
or external administration of byproduct (m) " Source material" means source -; material, or the radiation therefrom, to material as defined in the regulations ]; human beings: contained in Part 40 of this chapter; { (f)
- License," except where otherwise (n) "Special nuclear material" meam - g
- specified means a license issued pursuant special nuclear material as defined in (: ~ ~
to the regulations in this part; the regmlations contained in Part 70 of ( (g) " Microcurie" means that amount this chapter'-
- I of radioactive material which disinte-grates at the rate of 37 thousand atoms per second; (h) " Person" means (1) any indidd. ,
ual, corporation, partnership, firm, asso-clation, trust, &'.:. public or private institution, group, Government agercy , 9 other than the Commission, any State er any political subdivision of, or any pcliti- t cal entit/ within a State, any foreign 1 9
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. Wednesday, Januftry 11,1956 FEDERAL REGISTER 213 , .m 3 (o) " United States," when used in a (2) To transfer, receive, acquire, own, cant or licensec or a person duly author-r geographical sense, includes all terri- possess, use and import the quantitles of Ized to act for and on his behalf, tories and possessions of the United byproduct materials listed in ! 30.72, pro- (d) An application for license filed I States, the Canal Zone and Puerto Rico. vided that no person shall at any one pursuant to the regulations in this part (p) " Utilization facility means a time possess or use, pursuant to the gen- Will be considered also as an application j
y utilization facility as defined in the reg- eral licensing provisions of this para- for licenses authorizing other activities i ulations containea in Part 50 of this graph, more than a total of ten such for which licenses are required by the chapter: scheduled quantitles. (q) Other terms defined in section 11 act, provided that the application spcci-(b) The general licenses provided in fies the additional activities for which ([ cf the act shall have ese same meaning this section are subject to the provisions licenses are requested and complies with - ' j then used in the reg 11ations in this of !! 30.32 to 30.72, inclusive of the regulations of the Commission as to ap-part. l regulations in this part and are sub- p11 cations for such licenses. ; i I 30.5 Interpretations. Except as spe- , ject to the regulations contained in Part i 30.23 General requirements for is-i cifically authorized by the Commission -,0 of this chapter. na on,~ persons
! in writing, no interpretation of the o ans c , c ne suance of specirte heenses. An applica- i mesmng of the regulations in this part , p ed ie an1 tion for a spec 15c license will be ap-by any of!!cer or employee of the Com- quantities of byproduct material pur- proved th application is for a purpose (a) The mission other than a written interpre* suant to the general licenses provided in tation by the General Counsel will be paragr ra) of this section authorized by the act; and recognized to be binding upon the Com- gg) Il not c!Iect an iner' ease in the (b) The applicant's proposed equip-
#0"* radioactivity of said scheduled items or ment and facilities are adequate to pro-UNNS quantities by adding other radioacthe tect health and minimize danger to life material thereto, by combining byprod- or property; and 130.6 Persons operating Commission- uct material from two or more such items (c) The applicant is qualified by train.
l owned facilifics. Any person is exempt or quantities, or by altering them in any ing and experience to use the material from the requirements for a license set other manner so as to increase thereby I P " forth in section 81 or 82 of the act and the rate of radiation therefrom; ner to o he mize l (2) Shall not administer externally or dan
, i from the regulations in this Part to the extent that such person operates Com. internally, or direct the administration {d) The a pl e nt sat fles ny appil- l mission-owned plants and laboratories of, said scheduled items or quantitics or cable special requirements contained in on behalf of the Commission. In any any part thereof to a human being for ! 30"24*
such case, such person's obligations with any purpose, including, but not limited I 30.24 special requirements for issu-respect to the byproduct material are to, diagnostic, therapeutic, and research ance of specific licenses-(a) Human use covered by the applicable contract be- purposes. in institutions. An application by an j tween such person and the Commission. (3) Shall not add, or direct the addl. Institution for a specific license for I 30.7 Carriers. Common and con- tion of, said scheduled items or quanti- human use will be approved if: . trset carriers and the United States Post ties or any part thereof to any food (1) The applicant satisfies the gen ' ' Of' ice Department are exempt from the beverage, cosmetic, drug, or other prodl eral requirements specified in i 30.23; regulations in this part and the require- uct designed for ingestion or Inhalation and c ents for a license set forth in section by, or application to, a human being; (2) The applicant has appointed a (4) Shall not include said scheduled medical isotopes committee of at least > 81 cf the act transport to the extent byproduct thatinthey material theitems or quantities or any part thereor three members to evaluate all proposals regular course of their business as in any device, instrument, apparatus (in. for research, diagnosis, and therapeutic C1"8* cluding component parts and accessories use of radioiso. opes within that institu-thereto) intended for use in diagnosis, tion. hiembership of the committee l t 30.8 Other exemptions. The Com- treatment or prevention of disease in should include physicians expert in in-mssicn may upon the application of any human beings or animals or otherwise ternal medicine, hematology, therapeutic interested person, or upon its own initia. Intended to affect the structure or any radiology, and a person experienced in toe, exempt certain classes or quanti. function of the body of human beings assay of radioisotopes and protection j t.cs of byproduct material or kinds of or animals. against ionizing radiations; and uses or users from the requirements for (3) The applicant possesses adequate 1 a beense set forth in section 81 cf the i .2 App cations for speciAc h.- facilities for the clinical care of patients; !' act and in the regulations in this part, censes. (a) Applications for specine and when it makes a Dnding that the exemp. pcen es s e n u E 313, (4) The ph.rsician designated on the L:on of such classes or quantitles of such Application for By-Product Afaterial material or such kinds of uses or users L cense , with the United States Atomicsubstantial applicationexperience as the individual user has in the proposed ud! not constitute an unreasonable risk Energy Commission, Post O" ice Box E, use, the handling and administration of to the common defense and security and ak Ridge, Tennessee, Attention
- Iso. radioisotopes and, where applicable, the to the health and safety of the public, t pes Division, and shall set forth the clinical management of radioactive information called for by the form. In. patients; and stxtRAI, UCENsr.s; APPMCATIoNs roR formation contained in previous appli. '
ucrwscs ($) If the application is for a license cations, statements or reports fUed with to use unspecified quantities or multiple i I 30.20 Types oflicenses. (a) Licenses the Commission may be incorporated by types of byproduct material, the app!!. 1 I ' fer byproduct material are of two types: reference, provided that such references cant has previously received a reasonable I general and specific. The general !!. .are c! car and specific. number of licenses for a variety of by. eemes provided in i 30.21 are effective (b) The Commission may at any time product materials for a variety of human mout the allng of applications with the after the filing of the original applica. ms. , Ccmmission or the issuance of licensing tion, and before the expiration of the #"# # "# he[ pa e a pe sons Spe. license, require further statements in ~ vi al ph siclan for a s i tpon apphcations Bled pursuant to the rder to enable the Commission to de. for human use will be approvedIIcens if the tridations in this part' termine whether the application should applicant: x be granted or denied or whether a license (1) Satisfies the general requirements I 30.21 General licenses. (a) A gen. should be modified or revoked. specified in i 30.23; eral bcense is hereby issued: til To transfer, receive, acquire. own, (c) Each application shall be signed - (2) The applicant has access to a hos. bsecs and use byproduct material in. under oath or affirmation by the appli, pital possessing adequate facihties to (c
- hospitalize and monitor the applicant's t
crated in a device or equipment, s Attention la directed particularly to the radioactive patients whenever it is ich is listed in i 30/l1 and has been pronatona of the regulauons in Part 20 og advisable; and
!"snuf&ctured pursuant to a specific 11 this chapter which relate to the labeliing or (3) The applicant has extensive ex.
ceme issued by the Commission. . containers. perience in the proposed use, the han.
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. . 1 216
. . i RULES AND REGULATIONS -
dling and administration of radioiso- (b) The Commission may incorporate 1 30.34 Erpiration. Except as pro- 1 - topes, cnd where applicable, the clinical In any license at the time of issuance, or vided in 6 30.35 (b), each spect!!c license l, s ; mP.nagement (Th2 of radioactive patients. thereafter by appropriate rule, regulation shall expire at the end of the day,in the - g physician shall furnish suitable -or order, such additional requirements month and year stated therein. ,- Evidenc3 of such experience with his ap- and conditions with respect to the licen- - plication. A statement frorn the med- see'a receipt. possession. use and transfer 1 30.35 Renewal of license. (a) Ap. ical isotope committee in the institution of byproduct material as it deems appro- plications for renewal of a specific 11- l whtre he acquired his experience, indi- priate or necessary in order to: cense shall be filed in accordance with ! cs. ting its amount and nature, may be (1) Promote the common defense and I 30.22. submitted as evidence of such experi- security; I (b) In any case in which a licensee, cnce.) (2) Protect health or to minimize not less than thirty (30) days prior to (c) " Human use" of scaled sources. danger to life or property; expiration of his existing license, has An application for a specific license for filed an application in proper form for use of a scaled source for human use (3) Protect restricted data: will be approved if: (4) Require such reports and the keep- renewal or for a new license, such exist-ing of such records, and to provide for ing license r> hall not expire until the (1) The applicant satisfies the gen- such inspections of activities under the application for a renewal has been 1 tr:1 cnd rsquirements specified in i 30.23; license as may be necessary or appro- finally determined by the Commission. , (2) The applicant or, if the applica- priate to eHectuate the purposes of the 130.36 Amendment of licenses at re-tion is made by an institution, the ind!- act and regulations thereunder, cuest of licensee. Applications for vidual user (D has spectanzed training i 30.32 Terms and condmons of H. amendment of a license shall be filed in in the therapeutic use of the radioactive censes. (a) Each license issued pursu- accordance with I 30.22 and shall specify 1 ' drvice considered (teletherapy unit, beta ant to the regulations in this part shall the respects in which the licensee desires .
,I cppilcator, etc.) or has expertene eq iv- Su cet aI h po s of his license to be amended and the !
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dent to such trainM an a r grounds for such amendment. valid rules, regulations and orders of the 1 30.37 Commission action on appli- l
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( ) u'itiple quantities or types of by- Commission. 3 product material for use in research and cations to renew or amend. In consider. (b) Neither the license nor any right ing an application by a licensee to renew development. An appI! cation for a spe- tmder the license shall be assigned or or amend his license the Commission will cific license types for multiple of byproduct quantitles material for useorinotherwise provisions transferred of the act.in violation of the apply the apphcable criteria set forth in Il 30.23 and 30.24. risurch and development will be ap- (c) Each person licensed by the Com-proved if: mission pursuant to the regulations in 1 30.38 fnalienchflity of licenses. No - (1) *Ihe app!! cant satisfies the gen- this part shall confine his possession and license issued or granted pursuant to the 2 tral requirements specified in i 30.23; use of byproduct material to the loca* regulations in this part shall be trans. i , > and tions and purposes authorized in the ferred, assigned or in any manner dis- { (2) The applicant has received a rea- license. Except as otherwise provided posed of, either voluntarily or involun- i sontble number of licenses for a variety in the license, a license issued pursuant tarily, directly or indirectly, through cf rCdioisotopes for a variety of research to the regulations in this part shall carry transfer of control of any license to any # cnd d1velopment uses: and with it the right to receive, acquire, own, person, unless the Commission shs.h, I (3) The applicant has established an possess and import byproduct material after securing full informatforb find T' isotope committee (composed of such and to transfer such material to other that the transfer is in accordance with ' persons as a radiological safety omeer, a licensees within the United States au* the provisions of this act, and shall give representative of the business omce, and thorized to receive such material. its consent in writing, Cn1 cr more persons trained or experi. (d) Each license issued pursuant to i 30.40 Persons possessing byproduct Enced in the safe use of radioactive ma- the regulations in this part shall be material on efectme date of re0ulations terlils) which will review and approve' deemed to contain the provisions set in this part. (a) Any person who on the .j in advanceforofsuch purchase of radioisotopes' forth in section 183a.-d., inclusive, of the effective date of the regulations in this g i proposals uses; and ; act, whether or not said provisions are phrt possesses byproduct material pur-(4) The appucant has appointed a ra- expressly set forth in the license, diological safety omeer who win advise suant to an authorization heretofore i 30.33 Exports of byproduct materfat. issued by the Commission shall be on cr be Eva11able for advice and assist- (a) No licensee shan export byproduct deemed to possess such material pur-cnca on radiological safety problems. * (2) Afultiple quantities or types of by- material from the United States except "" ** product material for use in processing. as authorized pursuant to this section. ations in this part which shall expire . l An epplication for a specific license for (b) Any licensee may export byproduct ninety days af ter receipt from the Com. material covered by his license to any mission of a notice of expiration of such ' multipla uct material quantities for useor in types of byprod-processing forforeign country except countries or areas g 1
# D distribution to other authorized persons now or hereafter listed as Subgroup A erms and conMons imor-Uill be approved if. countries or destina' ions in i 371.3 of the $"Inco (1) The applicant satisfies the general Comprehensive Export Schedule of the ent 3ith o the requirements specified in i 30.23 and United States Department of Commerce vided f r in the regulations in this part.
(3) The appucant has received a rea- (15 CFR 371.3): Prorided. That the au- (b) Any authorization heretofore is-sonible number of licenses for processing thority conferred by this paragraph shall sued pursuant to the regulations in this t'nd distribution of a variety of radioiso. apply only to byproduct material having part shall be deemed to be a valid license topes; r,nd an(c) atomic number from 3 to 83, inclusive, during the period prior to the fxpirt-(3) The applicant has appointed a The Commission may upon ap- tion date set forth in said authoritation. t radhlogical safety omeer who will advise pIlcation by an interested person issue a Such license shall be deemed to include ' i Cn Er be available for advice and assist-product licensematerialauthorizing to a the country export or of areaby-all terms and conditions incorporated in ,
, l anca en radiological safety problems, listed as a Subgroup A country or desti- such authorization which are not incon-Lregxsts nation in 1371.3 of the Comprehensive sistent with or otherwise provided for in .
Export Schedule of the United States the regulations in this part, I 30.31 Issuance of specf/!c licenses Department of Commerce (15 CFR j ford1use a of byproduct termination thatmaterial. (a) Upon 371.31. or the export of byproduct ma- arconDs, arroars AND INsPEcrIONs an application terial not having an atomic number i 30.41 Records. (a) Each person t meetc th2 requirements of the Act and from 3 to 83, inclusive: Provided, Thag who receives byproduct material purst . (j , , th> Commission rIgulations of the will issue Commission, a specific license the the Commission will not issue a license ant to a license issued pursuant to the Duthirizing the paan*aalon and use of by- authorizing such export if, in the opin. regulations in this part shall keep rec.m[l s 3roduct material (Form A'.C 374 lon portofw the Commlulon, the proposed ex. ords showing the receipt, transfer, en
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- Byproduct Mateld M... ould nuiab* s einimimi be th* enmmnn liott n i.nrid til'omni of such bem
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FEDERAL REGISTER 217 Ecdnesday, January II,19% =-
- I 3032 , Reports of czports. Each 11 established by the Commission, or who
- eensee who exports byproduct matertaf uses such materials in violation of law or , Cyluma $ji _
from the United States shall, within 90 regulation of the Commission, or in a ***** *** Z" days from the date of such export, submit manner other than as disclosed in the 11rprodan mats a report to the United States Atomic application therefor or approved by the E*[j (mkro. N (mwra- 3 Energy Commission, Post Omce Box E, Commission. Oak Ridge, Tennessee. Attention: Iso-rNFoRCEMENT q topes Division, containing his name and 10 lo address, the name and address of the 1 30.01 Violations. An injunction or pja g I Q 1 g -g- ;g- , (1 d it h iav .. .. .. . so -m consignce, the name and quantity of other court order may be obtained pro- to la j the byproduct materialinvolved, and the hibiting any violation of any provision rhrnhnrus 32 (P 37). _ ' date of shipment. of the act or any regulation or order is- @%l*mylM; ... _ dl j a m sued thereunder. Any person who wil- Pr.a a4mmm isa 0 r su)...... io to m u - g 30.43 Inspection. (a) Each 11 - fully violates any provision of the act rr mmnum u: mrn im_. ~ in censee shall a!Iord to the Commission at or any regulation or order issued there- IN"i55 'iN!N$.T..~.:::~." $ $ all reasonable times opportunity to in- under may be rullty of a crime and, upon E ub'd ** $6 8 3(h " ------ -- IU 10 l " " *
,r spect byproduct material and the prem* conviction, may be punished bv fine or "$2b"Sa '# i a m - , 1ses and facilities wherein byproduct imprisonment or both, as provided by Fam.umm smnamm u (sc 40....
riisMif5... 30 io 1., s materialis used or stored. 3"'. N!N{N!b (b) Each licensee shall make ava!Iable senEDULEs 5 ! - mum :2 (x2 2a _ m m to the Commission for inspection, upon m 9 reasonable notice, records kept by him ! 30.71 Schedule A. The fonowing saimm 2e (N a m.. ~. . ... no pursuant to the regulations in this chap- devices and equipment incorporating by- N',7"U3"j $$i;fugy,yj;; m [t m _= i ter* product material, when manufactured, F uhr 3:. (s sa . . . -.. .... . M M w tested and labeled by the manuf acturer T *'" *
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I 30.44 Tests. Each licensee shall in accordance with the manufacturing, rEiS $ {N" ~ ~ ! $ $ l D -- --- M M -J perform, or permit the Commission to testing and labehng specifications con-perform, such tests as the Commission tained in a specific license issued to him If,$"m*ETY2 M"rl=1T(T'$$ . d E deems appropriate or naa.essary for the pursuant to the re~ulations in this part, Tin its sn im ... .. - io in , i i administration of the regulations in this are generally licensed pursuant to i 30.21 M 'u"n'${ T - 3? [ i i part, including tests of. Yurmm vo (v m9 1 to I (a) (1).
- 6 (a) Byproduct material, """ * " ( N - "'
i (a) Static climint.fion derice. Devices 8 (b) Facahties wherein byproduct ma- designed for use as static eliminators % 4 l terialis utilized or stored, which contain byproduct material con- N m N Mpomng and ncord4upbg (c) Radiation detection and monitor
- sisting of not more than 500 microcuries requirernents contained herein have been _
ing instruments,and . of polonium 210. approved by the Bureau or the Budget in : (d) Other equipment and devices used i" (b) Spark gap and electronic tubes. accordance with The Federal Rep 2rta Act a in connection with the utilization or stor. Spark gap tubes and electronic tubes or 1H2. ' age of byproduct material. which contain byproduct material con- Dated at Washington, D. C., this 28th troc:rICATIoM AND aEYoCATIoM oT LICTNsES sisting of not more than 5 microcuries of day of December 1955. . y
. I 30.51 Modi $ cation and rerocation of Ccs 9r ha o ri of o'ba t 60 K. E. PIEt.rs, GeneralManager.
)
{ licenses. (a) The terms and conditions per tube * " cf each license shall be subject to amend- " 1 ment, revision or modification by reason i 30.'I2 Schedule B. The following [F. R. Doc. 56-137; Filed. .Jan.10, 1G56; ( 4 :co p. m. ] j ( of amendments to the act, or by reason quantities of byproduct material are ~5 cf rtles, regulations and orders issued generally licensed pursuant to i 30.21 in accordance with the terms of the act. (a) (2). - i (b) Any license may be revoked, sus- ~ u pended or modified. in whole or in part, column enumn fer any material false statement in the h! N o.11 _ appheation or any statement of fact re- Noth a Asa cuired under section 182 of the act, or D"l"" "*L"# sewd e aied ; because of conditions revealed by such (m"'L. g - appheation or statement of fact or any cunn) cuna) repcrt, record or inspection or other ( c: cans which would warrant the Com- Antimm (n irth. 1 no m mission to refuse to grant a license on an Arsenic x M5 N.. .. - .. 10 M M
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!* crigmal application, or for violation of, Q(7 0$ggag" j;g .
,a cr failure to observe any of the terms 05aLatem ..... 1 in
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j a::d provisions of the act or of any rule, $yy Mgygg- '8 regulation or order of the Commission. w............... . . to in - (c) Except in cases of willfulness or r
- nun e Tasa._ -._ .. m m those in which the public health, inter- N'rfu"m"iNeIMiisdTmids' J est or safety requires otherwise, no wr iu t _ _ _ _ . . _ _ .. I m 14ense shall be modified, suspended or rescked unless. prior to the institution of DUNf cnronuum si (cr nu.',"...D*
3f," en no _ t oceed:ngs therefor, f act.s or conduct Q,Q"Q- -- : ,;;- d $ f " i
; sh.ch may warrant such action shall Norm,m is4 mu ss42.. . . . 1 10 i m e hac betn called to the attention of the nuorn w___...._
1.censee U. writing and the licensee shall U, $"l u N ;Ali' ' 7 ::.. $ $ . i tate been accorded an opportunity to wa se au i%. m . _ . . m m _ E demonstrate or achieve compliance with $rEn$$7/Jaisii!. :: as aE 'r = at: lawful requirements. indaun its an lies _ _ i n ' Imbnet3i d 1311... 10 m 130 $2 Right to scithhold or recall . Ind== i';(It 18:>... 30 lo a
$ j broduct mcterial. The Commission 72 $ $ $!n..... _ *$
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- n withhold, recall or order the with. 1stbanum im (14 iso)._ so ,
s ', $ 1 4 pdd;ng or recall of byproduct material M*"*n $ $ $[, w to
.rc= any licensee who is not equipped to Meipnum w (Me so _
Cherve or falls to observe such safety - ~ ~ - - - - - - j $ -
**andards to protect health as may be sbmm @@ @@4) anNt - . m a i j
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) ATOMIC ENERGY O@MMISSION Part 30 77 ) f h]\ y
@(\g U ffi (Reprinted from 24, Federal Register,1089, February 12,1959)
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- io\qi contained in Title 10 Code of Federal nism and indicator, if any, at no longer than six-month intervals; provided that W
F $ d((* Chapter Title1---Atomic 10-MDMIC Energy ENERGY Raulauons. Chapter 1. Part 30. anteens. ing of Byproduct Material" to each generally licensed person to whom he devices containing only krypton need n t be tested for leakage, and devices Commission f~hf[ PART 30-LICEN$iNG OF BYPRODUCT MATERIAL transfers a device conbintnr byproduct test d or an pufp "St*d"I-Becauseprocedures this amendment (iv) Shall have the tests required by estabushes subdWion (111) of this subparagraph additional for authorizing ~ Genero! Licensing of Devices the distribution of devices containing by- and an other services involving the' radio. product material, and immediate effec- active material, its shielding and c0n. On January 10,1959, the Commission tiveness will not adversely affect any per- tainment, performed by the supplier or issued for public comment a proposed son. the Commission has found that good ther person holding a specific license amendment to Part 30 providing for a cause exists why this amendment should """.ufacture, ces, instan or rervice such general license authorizing the posses- be made efective without the customary sion and use under specified conditions period of prior notice. (v) Shall maintain recor-is of all tests of certain types of mes uring, gauging Pursuant to the Administrative Pro- performed on the devices as required un-or controlling devices containing byprod. cedure Act, Public Law 404, 79th Con- der this section, including the dates and uct material. Experience has indicated gress, 2d Session, Title 10 Code of results of the tests and the names of the a need for a simplified procedure to Federal Regulations Chapter'I, Part 30 specific licensees conducting the tests; allow users of such devices to possess and a* Licensing of Byproduct Material." if (vD Upon the occurrence of a failure use byproduct material, when contained amended as fonows, effective upon filing of or damage to, or any indication of a in such devices, without obtaining a with the Federal Register Division: possible fallure of or damage to, the specific license. The Commission will 1. Add a new paragraph (c) to i 30.21 shielding or containment of the radio-continue to exercise control over the to read as follows: active material or the on-off mechanism manufacture and distribution of the de- or indicator, shsU 1mmediately suspend vices through its specific Licensing (c) (1) A general license is hereby is- operation of the device until it has been ed The general license will be sued to own, receive, acquire, possess and repaired by the tupplier or other person licabl nly to devices that are manu- use byproduct material when contained holding a specifh license to manufac-factured, tested, and labeled in accord- in devices designed and manufactured ture. Install or service such devicg or ance with specifications contained in a for the purpose of detecting, measuring, disposed of by trarsfer to a person spe. necific license authorizing supp y g gauging or controuing thickness, density, cificaUy licensed to receive the byproduct ch devices to generally licensed per- level, interf ace location, radiation, leak- material contained in the device; and ans. age, or qualitative or quantitative chem- (vil) Shall be ext =p from the re-
+ ical composition or for producing light or quirements of Part 20 of this chapter.
Each c.pplicant for a specific 3 cense to supply to general licensees devices e- an ionized atmosphere, when such de- except that such persons shall comply , signed and manufactured for the pur- Vices are manufactured in accordance with the provisions of Il 20.402 and with the specifications contained in a 20.403. pose of detecting, measuring, gauging or controlling thickness, density, leve!' specific license 1"ued to the supplier (3) The general license provided in pursuant to i 30af): Provided, That: . this paragraph is subject to the provi-interface location, quautative radiation,chemic or quantitative leakagh (1) The general heense contained in sions of $ 130.32 to 30.72, inclusive: composition, or for producing light or an this paragraph shall apply only to de. Provided. That persons who possess ionized atmosphere will be required t vices distributed under and in accord- byproduct material pursuant to this furnish sufncient information to assure ance with a specific license which states general Ucense shall not export such that, among other things, the device can that such devices when manufactured byproduct material without a specific be safely operated by persons not having pursuant to the terms of the specific H- license from the Commtuton authorizing any training in radiological protection cense may be distributed by the licensee such esport, and that under normal conditions of use 2. Add a new paragraph (f) in i 30.24 no person would be likely to receive more (11) That such devices are labeled in accordance with the provisions of the to read as follows: fica specific license which authorizes the dis. (f) Distribution of devices to persons posure e the tribution of the devices; and nsed 11 ill be required to apply psnerally licensed under i 30.21(c). An ahty c nt 01 rocedures to assure that (iii) That the device bear a label con- application for a specific license to dis-the device meets the required specifica- taining the following statement: tribute certain devices of the ty. pes tions. In most cases, testing of a proto. This device. senerany licensed pursuant to enumerated in 130.21(c) to persons gen-type of the device will also be required I 30.21(c) of to CFR. Part So, has been snan- erally licensed under i 30.21(c) will be prior to the issuance of a license author- ufactured and distributed pursuant to Azc approved if:
~ ' - + (l The appucant satisfies the general izing distribution to general Ifcensees.
Specific licensees will be obliged to re-De h ........ M .Qa .g..."pp5t) .u yequirements specified in 5 30.23; and port to the Commission on all transfers (2) Persons who own, receive, acquire, (2) The applicant submita sufBelent of the devices to generally licensed per. possess or use a device pursuant to the information relating to the design, man-sons; thereby ensbung the Commission general license contained in subpars- ufacture, prototype testing, quality con-to make appropriate inspections of the graph (1) of this paragraph: trol procedures, labelling, proposed uses (1) Shall not transfer, abandon or dis- and potential hazards of the device to use of the devices- pose of the device, except by transfer to provide reasonable assurance that: Under the amendment the general a person specifically beensed by the (1) The byproduct material contained licensees will be required to comply with Comrnission to receive such device; in the device will not be lost; certain restrictions which, in general will (11) Shall assure that all labels afBxed (ii) That no. person would receive a require that testing and servicing of the to the device at the time of receipt and radiation exposure to a major portion of
, + vices be accomplished by the manu- bearing the statement, " Removal of this his body in excess of 0.5 rem in a year Acturer or other persons holdmg spe- label is prohibited by regulations of the under ordinary circumstances of use; cific hcenses. To assure that the general Atomic. Energy Commission," are main- ( 111 ) The device can be safely operated beensee is informed of the obligations tained thereon and shall comply with by persons not having training in radio-h imposed on him, the specifically 11 censed all instructions contained in such labels: logleal protection; and supplier all! be required to furnish a (iii) Shall have the device tested for (iv) The byproduct material within leakage of radioactive material and the devlee would rot be accessible tc un-copy of the generallicense provisions as proper operation of the on-off mecha-w.. - a ,
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I. 6 S + .d },[ r tuthorisedpersons b 'E $I, . (3) In describing the label or labels j gnd contents thereon to be afRzed to the ,- 7 device..the applicant should separately ' I indicate those instructions and preceu. _. tions which are necessary to assure sale yy operation of the device. Such instruc. y tions and precautions must be contained r- ' ,M-3 on labels bearing the statement. Re= , D moval of this label prohibited by regula- Q tions of the Atomic Energy Ca==laston." , 'f
- 3. Add a new paragraph (e) in i 30.32 i to read as follows:
fe) Each licensee authorised under k 130.24(f) to distribute certain devices to generally licensed persons: . (D Shall report to the Director. Di. . . vision of Licensing and Regulation an transfers of such devices to persons gen- .
^.
erally licensed under 130.21(c). Such i' report shall identify each general 11 censee by name and address. the type of device transferred, and the quantity and , type of byproduct material contained in - the device. The report shall be sub-mitted within 30 days after the end of each calendar quarter in which such a - device is transferred to generally 11 censed persons; and ' (2) Shall furnish to each general 11-censee to whom he transfers such device a copy of the generallicense containedin i 30.21(c). (sec.161, se Stat. 948; 42 U.S.C. 3201) Dated at Germantown Md., this 9th day of February 1959. 4 For the Atomic Energy Comminalan. q, j A. R. Ltrasscus. - ~' GeneralManager. 1 1 [F.R. Doc. Os-1900: Filed. Feb. 10. 1980; 2:18pJn.1 )' i t 9 k y*,
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M, - u ] c-U. S. ATCMIC EIERGY CODMISSION PART 30
'i i e (Reprinted in 27 Federal Register, 531, January 18, 1962) -
g 1 1 i 1 I The exemption and general licenses would apply only to physicians defined Dgy NUMlqqlfly in 10 CFR 30.4(1 as "* *
- an individ-ATOMIC LRuI vvmmivulUn ual licensed by a state or territory of f 10 CFR Part 301 the United States, the District of Colum-blaer the Commonwealth of Puerto Rico ,
EXEMPTION OR GENERAL LICENSING to dispense drugs in the practice of med- , OF CERTAIN BYPRODUCT MATE. icinc." Cobalt 60 needles and tuks ! q RIALS FOR MEDICAL USE would be generally licensed for use by a , i physician who has at least three years Notice of Proposed Rule Moking of experience in the interstitial or intra-A number of byproduct materials,such cavi'.ar* use of sealed sources containing as iodine 131, phosphorus 32, chromium radioac'ive materials, and who certifies 51, cobalt 58, and cobalt 60, have been to the Commission that he is familiar used for medical purposes for several with &a hazards and appropriate pre-cau ons associated with such sealed years. Considerable experience has been 'y, obtained also with variouy devices con- TPe ' general licensees would be re- f wirkt rerister with the Commission ar6 r -ceive a registration number prior Th issio co kers that the uses, contraindications, and necessary te obtaining the byproduct material or , precat;tionary sneasures for safe han- device for use ur. der the generallicense. g tiling of certain of these byproduct mate- The ces.d?tioin to which the general j 11 cent v cul* be ;ubject will be repro-rials and devices have been determined. j It appears feasible and desirable, there- du :ed ucon cre Eecistration Certificate. ; fore, to exempt physicians from the Ths, he win *,e infonned of the con- ' licensing requirements of Part 30 for ditions of the ger.eral license. relatively smallquantities of certain by- The proposed amendments also would product materials. It also appears feasi- cstabhsh licensing criteria for persons ble and desirable to issue a general yoposing to distribute byproduct ma-license to physicians forlarger quantities terial for use by physicians who would be i exempted or generally licensed by the of these byproduct materials if appro-priate radiation safety limitations are amendment. made a condition of the generallicense. 8747xMINr oF RADIAT!oN SAFETY The proposed amendments would ex- CONSIDERATIONS empt the use for diagnostic purposes by physicians of iodine 131, cobalt 58, cobalt Section 30.11: Under the provisions of 60, and chromium 51 in specified forms the exemption in l T3.11 the pharma-and relatively small cut.ntitles. A gen- ceutical containing radioactive material eral license would be established for the would be packaged in individual cali-medical use of iodine 131 and phosphorus 32 in specified fonns and limited quan-tities sufBcient for certain therapeutic and diagnostic unes. The exemption and this generallicense would apply only a to byproduct material obtaiaed from a supplier holding W kn effective new drug application, or llemsa isrued by the Secretary,Dt part:nent of Health,Edites-tion, and Welfare, e,nd (b) e 11cer.re issued by the Atomic Fnergy Commis-alon under i 30.24 fO of the proposed amendment. A generallicense would be established also for needles and tubes containing cobalt 60.
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4 l i E breted doses ready for administration, in the radioisotope diagnostic programs bottle containing 15 millicuries of iodme - E No processing by the physician would be are so small that personnel monitoring 131 could be as high as 0.55 roentgens 7 - required The radioisotopes would be equipment is not required under the pro- pe: m:nute The provisions of the rcn- ). , s j - used only by physicians and for medical visions of I 20 202 of 10 CFR Part 20. tra lweme would,in effect require that f = diagnosis. The proposed exemption re. Because of the low levels of radiation the todmc 131 be kept in a shielded con- j quires that the radioacthe material be involved and the manner in which diag- tamtr v hich would reduce the radiation " stored. until administer ed. in the original nostic radioisotopes are used, there is level et the container surface to 200 , shipping container or 6 container peo. no need to specify minimum tratning m: hr and at one meter from the con- 1 = siding equivalent radiation protection. or experience requirements for physi- tmned radioactise mattrial 10 mr br- I E The maximum quantitles of radicactive clans. Pui ther. a radiation turvey meter Ikcause of the shieldmg of the storan E material which a physician could possess is not needed. In the case of cecidental c onta m<T and the routine manner m - j at any one time under the exemption spills, which are infrequent. the radia- w hich the mattital b used, the radiat2on would be 200 microcuries of lodme 131; tion instrumentation used by the licensee dcsrs to physicians end technicians . [ 10 microcuries of cobalt 58; 10 micro- to interpret results of the diacnostic v oi k m;: with the material are kept well l , curies of cobalt 60; and 200 microcuries tests can be used to chrek for contami- b low t!.c exporure limits of 10 CFR 3 of chromium 51. nr. tion There is litt!e likrhhood that c nit 70 t The radiation doses received by phy- the radioisotopes will be ingosted or in- Special piccautions are required in U.e
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sicians or technicians in the administra- heled by medical per:onnel since no handling of patients containing thera-tion and handling of diagnostic doses of processing of the radioisotopes will be peutie leveb of lodine 131 with respect to E rcdioisotopes thich would be exempted involved. Since diagnostic indioisotopes catcroal radiation in the vicinity of the 5 cre quite small. Interstate Commerce are ordered by physicians on an as patient and with respect to vomitus and -- L Commission regulations specify that the needed basis. Very little of the material excreta. Extrapolating calculations = rediation on the surface of a shipping is disposed of as w aste. riven by Quimby/ the maximum dore container shall not exceed 200 milliroent- Section 30.26: Iodine 131 and phos- which a nurse would be expected to re- t* gens per ho:4 tmr hrt and at one meter phorus 32 shich would be scnerally ceive w hile caring for a patient contain-from the contained radioactive material licensed under i 30.26 would be pack- ing 15 millicuries of todine 131 for six ( ch ll not exceed 10 mr,hr. In practice, aged in individual doses ready for ad- days would be about 25 millirem to the the radiation levels about containers of ministration. No additional processing shole body and 250 millirem to the !*" diagnostic doses of isotopes are much of the material would be required and hands. A special duty nurse sould be - less than these maximum allowable the radioisotopes would be used only by expected to receive a whole body ex-levels. The radioisotope container is physicians and only for medical diag- posure of about 50 millirem during the handled by physicians and technicians nosis or therapy. The maximum quan- same period because of the extra time = y for very short periods of time. Remote titles of radioactive material which a spent in the room. , hsndling equipment is unnecessary. The physician could possess at any one time The general license would apply only dose rate at a distance of one centimeter under th:s general heense would be 15 to iodine 131 and phosphorus 32 in cap-from a point source of 200 microcurica milhcuries of iodine 131 and 10 milli- sules or other forms of prepackaged in-cf todine 131 is about 440 mr/tr or 7.3 curies of phosphorus 32. dividual doses. Capsule form reduces mr/ minute. A bottle of iodfne 131 Since phosphorus 32 is a pure beta the possibility of radio-contamination if 3 cepsules is not a point source, but the emitter, the radiation dose rates re- the pharmaceutical is dropped. Sup- ( dose rate close to it would be of this ceived by the hands of persons who han- plicts of the general licensed radioiso- , __ e order of magnitude. dle this isotope in closed containers is tepes sould be required under the pro- ' The dose rates from the other diag- quite low. The bremsstrahlung dose visions of I 30.24(k) to provide the gen-nostic radioisotopes which would be ex- rate through the walls of a glass bottle eral licensee with instructions as to the - Empted will be much lower than for containing 5 millicuries of the isotope precautions to be observed in handhng I
=
iodine 131. We dose rates at one centi- is about 0.5 mr/hr at 10 centimeters this material. These instructions would !
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meter from point sources of 10 micro- from the bottle. The surface dose rate be approved by the Commission's staff l 5 curies of cobalt 58,10 microcuries of co- could be as high as 0 5 x (10 N ,10 mr/hr. prior to issuance of a license to the sup. ; balt 60 and 200 microcuries of chromium Quimby
- found that the dose rnte at the plier authorizing him to distribute radio- i 1 51 cre 60 mr/hr,128 mr, hr and 80 mouth of an "open" bottle with a 3 isotopes to general licensees. With the !
mr/hr respectively. square centimeter area and 5 etrtimeters safety instructions issued by the radio- i d" 10 CFR Part 20 specifies that the deep, containing 10 mil 11 curies of phos- isotope supplier, these radioisotopes h.nds of radiation worker:. may be ex- phorus 32 was as high as 100 rads per should be used in a safe manner. posed to 18% rems per quarter or an hour. Hence, precautions must be taken Because of the high levels of radiation = cverage dose of 1440 millirem per week. shen handling this isotope to assure that associated with millicurie amounts of If cn individual were exposed only the hands are not overexposed. How- unshielded phosphorus 32 and iodine 131. ' i through the handling of 200 micro- ever, because of the type of container in and possible contamination which could - curies of lodine 131, he could handle the which the isotope is received and the result from vomitus and excreta, a ra- l cup or bottle contairdng the radioisotope manner in which the material is used, diation survey instrument is considered WS s=198 minutes each week without the radiation doses to physicians and necessary for use by the general licensee t exceeding the limiting hand dose estab- technicians working with phosphorus 32 at all times to assure the safe use of ; 11shed by 10 CFR Part 20. In practice, are normally low. this material. " diagnostic doses of radioisotopes are The radiation levels outside of the As in the case of diagnostic radioiso- - i t htndled only one or two minutes during bodies of patients who have been given topes. therapeutic doses are ordered by
- m each administration and in a large phosphorus 32 are quits low. There *is physicians on an as needed basis. Con- ! E diagnostic program perhaps no more no external hazard to nursing personnel sequently, very little waste material re- -
thin ten cues a week would be invo;ved. who care for such patients. Instructions sults. Because of the short half-lives ! The hand doses received by physicians for nursing personnel are standardized of lodine 131 and phosphorus 32 any : cnd technicians from handling diagnos- with respect to precautions to be ob- contaminated equipment, including bed. ' ; tic doses of radioisotopes are small. served in the' event the patient shou'd ding. can be stored until the radioac. " g The whole body exposures to medical vomit af ter or al administration and pre- tivity has decayed to safe amounts. = personnel are hkewise small from the cautions to be observed regarding ex- The proposed generallicense of 5 30 26 8 handlmg of these doses. The dose rate creta. sould not require the hospitalization of ct one foot from 200 microcuries of un-
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Therapeutic doses of iodine 131 are patients containing radioisotopes. De ahielded iodine 131,10 microcuries of normally handled with forceps or tongs levels of radiation about patients con-d unshielded cobalt 58.10 microcuries of to reduce the radiation exposure. ne talning phosphorus 32 are very low. E unshielded cobalt 60 and 200 micro- dose rate at the surface of an unshielded Those about patients containing lodme 5 curies of unshielded chromium 51 are 131 are substantial but are not con-0.5 mr/hr, 0.06 mr/hr, 0.14 mr/hr and ' Quunby. gdtth H . *aafe Handling of Ra- sidered sumciently high to warrant hos- 6 - 0.09 mr/hr, respectively. Doses received otometae isotopes in Medical Practice. m pitahzation. Such patients are per- l _ by physicians and technicians who work MacMittan ecmpany i19e0. mitted to return home after adminis. '_" _ 2- '
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- tration under present specific lic:nsing the experi:nc2 a:Ined over sever;l ynrs in event m5nuf a leaking acturer cf the sealedsourc3sources is found. The would procedures. ni dose rcte et ene foot in th? use Cf radium.
- 2. Apphc:fion to patienf. Cobalt 60 be requir:5 to test sources f allo ring from the thyroid cf o patlInt who is ad-ministered 30 mil 11 curies of iodme 131 source s are normally cpplied to patients mtnufacture to assure thit they cre is initially less than 20 mr/hr. Approxi- in the operating room. They are trans- properly sealed. Also, each source must 1 mately 60 percent of the radioisotope shielded is ferredcontamer M the operating room in their be individually calibrated and marked and placed in the by the manufacturer so as to identif y the i
Eliminated by urinary excretion during patient by use of remote manipulators. number of milheuries and hnear inten- ! th2 nrst 48 hours and thereafter the radi: isotope is reduced 50 percent each The time required to insert sources in sity of Anyeach needle physician or proposes who tube. to recebe 1 week due to biological and radiological patients methods is kept of at a implant minimum are since determined theinbyproduct material under general license j deccy.' ne generallicense would require each advance. Sources are packed in place would be required to register with the with dressings and special appliances Commission prior to receiving the ma-physician tho proposes to receive by- to assure that sources are not acciden- terial. The general licensee sould not product material under the provisions be permitted to transfer, abandon or cf the generallicense to register with the tally 3. extruded Irradiation fromof the patient. pafienf. Procedures dispose of the radioisotope except by Commission prior to receiving the by- transfer to a person generally or spe-product material. Registration wn!! pro. for caring for patients with cobalt 60 cifically licensed to receive the material. vide the Commission with the names and implants are well established. Special addresses of the generally heensed phy- instructions are required for nursing per- Purther, persons who manufacture and siclins so that inspections may be con- and sonneltimes totoadvise spendthem in theof safe distances vicinity distribute of the of I 30.24(1) cobalt would be 60 required underbythe provisions I 30.32 ducted by the AEC. patient, and to inform them of what (g) to inform the Commission of all Section 30.28: Cobalt 60 sas one of the first artificial radioisotopes to be used should be done !! a tube or needle should transfers of cobalt 60 to generallicensees. ther:peutically, since it seemed to be be extruded from the patient. Under the Because of the possible har.ards of the thi most suitable replacement for provisions of the general license the radioisotope in the hands of an untralned radium? Needles or tubes of this physician structionswould be supplier by the suppliedofsuch in- person, the byprod. the reporting considered necessary. requirements Further, this are will T-dioisotope are used to supplement or enable the Commission to perform . replace radium in intracavitary or inter- uct material. l f Because of the high dose rates about inspections of the general licensed ' ' statitl treatments. The dosage delivered patients containing cobalt 60 needles physician. by 0.646 millicuries of cobalt 60 is the or tubes, the proposed general license Pursuant to the Atomic Energy Act of same in toentgens per hour as that de-livered by one milhgram of radium would require hospitalization of the 1954, as amended, and the Administra-filtered by 0.5 mm of platinum? The patient until the byproduct material is tive Procedure Act of 1946, notice is procedures for cobalt 60 therapy are removed. The dose rate at three feet hereby given that adoption of the fo!- tssentially the same as for radium. from a patient of the isotope containing may be as 100 millicuries high lowing amendments as 155 templated. All interested to persons Part 30 is con. who Cobalt 60 is a relatively corrosion re- mr/hr. A radioisotope record card con- desire to submit written comments or sistant metal while radium is a powder the radiation caution symbol suggestions in connection with the pro- i (rrdium sulf ate). Absorbed cobalt 60 is talning would be required to be attached to the posed amendments should send them to rapidly excreted while radium may be patient's bed or to the door of the room the Secretary, United States Atomic En- l deposited in the bone. in u hich the patient is hospitalized. The ergy Commission. Washington 25. D.C., Cobalt 60 needles are prepared by card would accompany the patient when- within ninety (90) days after publica-hermetically sealing small segments of ever he leaves his room as long as the tion of this notice in the Frpraat Rects-cob;1t 60 wire in stainless steel tubing radioisotope is contained in his body. t aa. Comments received after that i and other corrosion resistant metals. The card would serve to give warning to period will be considered if it is prac-Thry are essentially the same size as radium needles. Needles are placedpatient anyone performing in order services to minimize for the the'.r radia- ticable to alderation cannot do so, but assurance of cou-.l directly in the tumor mass with thread tion exposures. comments filedbewithin given except as to the period or cire by which they may be withdrawn 4. Remoral of sources. Sources may specified. after the desired dosage has been be removed in the operating room or at 1. A new I 30.11 is added to read as delivered. the patient's bedside. They are immedi- follows: There are five stages during w hich ately nturned to the storage container. 8 30.11 Exemption of eerimin quantitico ; r diation hazards may exist riurmg the Special care must be taken whcn remov- of byproduct material for medical use of cobalt 60. These are listed below ing the sources to assure that all sources l along with a discussion of each. placed in the patient are accounted for.
- 1. Storage and transfer from storage. The proposed general license would re- (a) A physician is exempt from the Under the provisions of the proposed quire that a physical inventory of the requirements for a license set forth in g neral license the cobalt 60 must be cobalt 60 needles or tubes be conducted section 81 of the Act and from the regu.
af ter each use to account for all byprod- lations in this part to the extent that ; e or co he receives, possesses, uses or transfers . wh ch the c al isre uct material used. tainer providmg equivalent radiation 5. Dismantling of cobalt 60 applicator in accordance with the provisions of l protection. The maximum radiation and return to stock. Following removal paragraphs (b), (c), and (d) af this I; vel on the surface of the container of the sources from the patient, the ap- section the following byproduct mate. could be 200 mr/hr and at 1 meter plicator is dismantled behind shielding rials: (1) Iodine 131 in capsules, disposable from the contained radioactive material with remote manipulators, cleaned and 10 mr/hr. The sources are prepared for returned to the shielded container for hypodermic syringes or other forms of "8* *I " future use. These procedures are well prepackaged ind vidual doses. e n (2) Cobalt 58 in capsules or other 73 beht d el - !o established. e s d radauon fortns of prepackaged individual doses. ecause e e i e t in uch as the ose r te one ass ciated with the millicurie amounts (3) Cobalt 60 in capsules or other ; foot from 100 millicuries of unshielded c bah 60 which wodd be used, the forms of prepackaged individual doses. cobalt 60 is 1.4 r/hr. Procedures for generallicense would require the licensee (4) Chr "" $1' trnnsfer are well established because of to maintain and use a calibrated radia- (b) A physician shall not possess at tion survty instrument in his program. any one time, pursuant to the exemption
' Quimby. Edith H..
- Safe Handling of The instrument would also be useful to in paragraph (a) of this section more
' P W locate any source which is accidentally n.
El11an compa (9 . extruded from a patient. Blabd. William H., et al.. "The Practice of The provisions of the general license (1) 200 microcurfes of lodine 131. and ** Nuclear Medicine." Charles C. Thomas (1958). require that the sealed source shall be (2) 10 microcuries of cobalt 58. and
' oulmby. Ednh H., et al "Radioncun (3) 10 microcuries of cobalt 60. and totopes in cunical Praeuce? Isa and tested for leakage at twelve-month in. (41 200 microcuries of chromium SL
) Pibiger (1958), tervals, and specify what should be done i
-,%m.
_ _ _ . _ . _ . - - - - - - .L- - - - - - - 1 cf (cithisThe exemption section in paragraph is Cective Cnly then: (c) secti:n, unless the container be;rs o container is used for storage the libel i# label tyhich includes thz f111owing shall also state th2 quanti'tes and kinds (1) The contain1r (f the pharm > statem:nt: "This pharmaceutical may of radnosctive materials in .he container i h reutical bears a tabel which includes the be distributed to physicians puituant to and the date of measurement of the I f;110 wing statement: "this pharma- generallicense 10 CP7130.26 of the U.S. quantitles. ceutical may be distributed to physicians Atomic Energy Commission." t under license exemption of the U.S (14) He shall assure that each area or Atomic Energy Commission." (3) Ile shall use the pharmaceutical room in which a total of more than 100 %i received pursuant to the general license microcuries of iodine 131 or phosphorus ' ' ' ' (2) The byproduct material is stored, in paragraph aat of this section only 32 is used or stored, excluding byproduct until administered, in the original ship- for those uses described in the label or material contained in patients, is con-ping container or in a container provid- brochure accompanying the package. spicuously posted with a sign bearing .4 ing equivalent radiation protection. i (4) Ile shall not transfer, abandon, the conventional three-bladed radiation (d) A material product physician whothe under possesses exemption by-in or dispose of the phatmaceutical except: symbol and the words: " Caution-Ra- , ) (in By transfer to a person authorized dioactive Material (s)," Such posting is this section: to receive the byproduct material pur- not required for an area or room which j (1) Shall use the pharmaceutical re- suant to a specific license issued by the is under the licensee's control, and c;lved pursuant to the exemption in Commission or pursuant to the general which contains byproduct material for ; i j i paragraph (a) of this section only for license in paragraph (a) of this section. less than eight hours, if the materials those uses described in the label or clin By release into a sanitary sewer- are constantly attended by an individual brochure accompanying the package. l pie system: Provided, hotcerer, That who will take necessary precautions to ** (2) Shall not transfer, abandon, or the total quantity of byproduct material minimize exposure of individuals to the l dispose of the byproduct material except released into the sanitary sewerage radiation. t by transfer to a person authorized to system by the general licensee does not (15) IIe shall comply with such radi- ! receive the byproduct material pursuant exceed more than 100 microcuries in ation safety instructions which accom-to o specific license issued by the Com- any twenty-four hour period and the pany the shipment of byproduct material mission or pursuant to the exemption total quantity of byproduct material re- and are referenced in the label attached in paragraph (a) in this section or the leased into the sanitary sewerage sys- to the container of the byproduct g n;ral license in i 30.26(a). i tem by the general licensee does not material. (3) Shall not transfer the byproduct exceed 100 m1111 curies in any one year. , ; ;' material to another person except in the 116) IIe shall report by telephone or (5) IIe shall not transfer such phar- telegraph to the Director. Division of unopened, rec;ived fromlabeled shipping container as ,maceutical to another person except in Licensing and Regulation, Atomic En-the supplier-the unopened, labeled shipping con- ergy Commission within 24 hours after
- 2. A new I 30.26 is added to read as tainer as received from the supplier, its occurrence becomes known to the 11-f 1}ow3'. i6) He shan store the pharmaceutical censee any loss or theft of more than one
$ 30.26 Cencral Iken.c. certain dian"*- ping until administerrd, in the original ship- millicurie of iodine 131 or phosphorus 32.
tic and therapeutic aguantines. container or a container providing (d) In addition to the conditions, equivalent radiation protection, limitations and requirements of para-(:) A general license is hereby issued (U He shall not use the pharmaceu- Irraphs (b), (c), and (d) of this section. to any physician to receive, possess, use, tical for any purpose other than medical the general license provided in para- i or transfer in accordance with the pro- diagnosis or therapy. graph (a) of this section is subject to vistins of paragraphs (b), (c), and (d) (8) He shall maintain, at each facility the conditions. limitations and require-(f this section the following byproduct where the byproduct material is used, ments of l130.32, 30 33, 30.41, 30 42, l' m terials: a calibrated and operable radiation sur- 30 43,30 44,30 52, and 30.61 of this part (1) Iodine 131 in capsules or other vey instrument capable of measuring (e) The general licensee under para-f:rms of prepackaged individual doses. from 0.1 millirad per hour to 20 milli- graph (a) of this section is exempt froni (2) Phosphorus 32 in capsules or other rads per hour of the radiations emitted the requirements of Part 20 of this forms of prepackaged individual doses. by the material generally licensed pur- chapter with respect to the byproduct (b) No physician shall receive, possess, suant to paragraph (a) of this section. materials covered by the general 11 cense. j use, cr transfer byproduct material pur- (9) He shall cahbrate or have cali-suant to the general license estab!!shed brated each survey instrument at inter- 3. A new I 30 28 is added to read as I by paragraph (a) of this section until vals not to exceed six (C) months and follows: i h1 hr after each servicing. 9 30.28 General license, cobalt 60 for l (1) Piled Form AEC 482," Registration (10) He shall secure byproduct ma- interatitial, intracasitary therapy, I C;rtiL 6e-Medical Use of Byproduct terial against unauthorized removal fa) A general license is hereby issued M terial Under General License" in from the place of storage. to any physician who has at least three triplicate with the Director, Division of (II) He shall survey the immediate years of experience in the interstitial or Licensing and Regulation. U.S. Atomic areas in shich iodine 131 or phosphorus intracavitary use of sealed sources con-Energy Commission. D.C.,and Washington 25 32 is used for possible contamination taining radioactive materials, and certi- i immediately following a spill or unac- fles to the Commission that he is famil-(2) Received from the Commission a counted loss of any quantity of todine tar with the hazards and appropriate validited with registration copy t>f the Form number AEC-482 131 or phosphorus 32 and shall decon- precautions associated with such scaled assigned. i taminate such areas to a level not ex- sources, to receive, possess, use, or (c) A physician who receives a phar- ceeding 2 millitads per hour measured transfer, in accordance with the pro-maceutical teri'J pursuant containing byproduct to the general ma- atsurface. license a distance of one centimeter from the sisions of paragraphs (b), (c), and (d) established by paragraph (a) of this of this section, cobalt 60 contained in (12) He shall maintain records show- needles or tubes designed and manufac-section shall comply with the following: ing the dates of cahbration of each sur- , tured for interstitial or intracavitary ' (1) He shall not possess at any one vey instrument, names of persons who therapy. time, pursuant to the general license performed the calibrations, and the re- (b) No physician shall receive, possess, in thin: paragraph (a) of this section, more sults of surveys required by subpara- use, or transfer byproduct material pur-I graph (11) of this paragraph. I all 15 millicuries of iodme 131 in cap- (13) He shall assure that each con- suant to the general license established I sules or other forms of prepackaged tainer in which a quantity of snore than by paragraph (a) of this section until individual doses, and 10 microcuries of lodine 131 of phos- he W' i (11) 10 millicuries of phosphorus 32 phorus 32 is transported, stored, or used (1) Pilad Form AEC-482-A, Regis- l in crpsules or other forms of prepack- bears a durable, clearly visible label tration Certificate-Generally Licensed
- i aged individual doses. beanng the conventional three-bladed . Medical Devices," in triplicate with the (2) He shall not receive, possess, or radiation symbol (magenta or purple on Director, Division of Licensing and use the pharmaceutical pursuant to the yellow background) and the words: Regulation, U.S. Atomic Energy Com-gImrd license in paragraph ca) of this " Caution-Radioactive Material." If the mission, Washington 25, D.C., and l
t j i i t.
. 1
_ . _ m I =.- _ . ~ _. _ _ _ _ - _ . t ^. 1 I (2) Received from the Commission o needles tr tubes to account for all the the physicirn, any loss cr thef t of a co-vnlidated copy of the Form AEC-482-A byproduct material used. balt 60 needle er tube. with registration number assigned. (11) He shan hospitalise any patient (18) He shall maintain records of: (c) A physician who receives by- in whom the physician has inserted co- (1) All testa performed on the cobalt l l product material pursuant to the gen. balt 80 until such time as the cobalt 60 60 needle or tube as required under this l , eral license established by paragraph is removed from the patient. section, including dates and results of (a) of this section shall comply with the (12) He shall complete and attach a the tests and names of individuals who [* following requirements: radioisotope record card to the bed or to conduct the tests. j l (1) He shall not possess at any one the door of the room in which a patient (11) Dates of calibration for each sur-time, pursuant to the general license in with cobalt 60 in his body is hospitalized. vey instrument and names of persons l paragraph 4a) of this section more than The card shall accompany the patient who performed the calibrations. i 100 millicuries of cobalt 60. whenever he leaves such room and shall (iii) Inventories of cobalt 60 needles I (2) He shall not receive, possess, or include the following: or tubes. use byproduct material pursuant to the (in The conventional three-bladed (iv) The radiation dose of all indi-l seneral license in paragraph ta) of this radiation caution symbol. viduals for whom personnel monitoring , l section, unless the container bears a tit t The name of the patient. is required by subparagraph (15) of this I label which includes the following state. ( 111 ) ne number of milheuries of paragraph. l ment: "This device may be distributed cobalt 60 shich have been administered (v) Radiation surveys required by to physleians pursuant to general license to the patient. I 30.28(c) (16) . 10 CFR 30.28 of the U.S. Atomic Energy tiv) The name of the physician in (19) He shall comply with such radia. Commission? charge. tion safety instructions which accom- , (3) He shall have the cobalt 60 needles (13) He shall post each area or room pany the shipment of byproduct material l and tubes tested for leakage of radio. In which a cobslt 60 needle is being used and are referenced in the label attached I active material by a person specifically or stored with a sign bearing the conven- to the container of the byproduct ma-licensed by the Commission to perform tional three bladed radiation symbol terial. such tests, at no longer than twelve- (tr.agenta or purple on yenow back- (d) The general license provided in month intervals by a test capable of de- grounds and the words: " Caution-Ra- paragr aph (a) of this section is suoject tecting the presence of 0.005 microcurie dioactive materialts)." to the provisions of Il 30.32, 30.33, 30.41, of removable contamination on each (i) Such posting is not required for an 30.42,30.43,30.44,30.52 and 30.61 of this I sealed source. Any test which reveals area or room which is under the licensee's part. l the presence of 0.005 microcurie or control and which contains cobalt 60 (e) De general licensee under para-more removable radioactive material needles or tubes for less than eight hours graph (a) of this section is exempt from shall be considered evidence that the if the cobalt 60 is constantly attended the requirements of Part 20 of this chap-sealed source is leaking. by an individual who will take necessary ter with respect to the byproduct ma-(4) He shall immediately withdraw precautions to minimize exposure of in- terials covered by the general license. from une any cobalt 60 needle or tube dividuals to the radiation. which is leaking or has been damaged (11) Such posting is not required for 63 mendmend or broken and shan cause it to be re- a room or other area in a hospital be- 4. A new paragraph (k) is added to paired by the supplier or other person cause of the presence of cobalt 60 needles 130.24 to read as follows: holding a speciSc license issued by the or tubes in patients provided there are (k) Afanufacfure and distribution of Commission to manufacture or repair personnel in attendance who will take byproduef maferial for exempt or gen-
, such needle or tube, or dispose of it by necessary precautions to minimize the erolly heensed medical use. An apphea-transfer to a person speciScally licensed exposure of other persons to the tion for a speciSc license to manuf acture, by the Commission to receive the by. radiation. Import, label, package, and distribute by-product material. A report shan be filed (14) He shall not possess, use or trans* product material for use by physicians in duplicate by the physician within 10 fer generally licensed byproduct material exempt from licensing under i 30.11 or days after determining that any needle in such a manner as to cause any in- generally licensed under i 30.26 will not or tube is leaking, with the Director, Di- dividual, other than a patient to whom be approved unless-I vision of Licensing and Regulation, U.S. the byproduct material is administered. (1) The app 11can't satisSes the general Atomic Energy Commisalon, Washington to receive in any period of one calendar requirements speciSed in i 30.23.
- 25. D.C., describing the type of needle or quarter from generauy licensed by- (2) The applicant submits evidence
. tube involved, the test results, and the product material and other sources of that the byproduct material is to be corrective schon taken. radiation in the licensee's possession a manufactured, labeled, and packaged in l
(5) He shall not transfer, abandon, dose in excess of the limits specified in accordance with a new drug application l or dispose of the needle or tube except by the following table: which the Commissioner of Food and transfer to a person authorized to receive Rema Per Calendar Quarter Drugs, Food and Drug Administration, (n wh le b dy; head and trunk; ac. has permitted to become effective, or in I ce is ed by the mis uve blood-forming organs: accordance with a license issued by the alon or pursuant to the general license tens or eyes: or gonads.... 1% Secretary, Department of Health, Edu-in paragraph (a) of this section. (u) Hands and forearms, feet and (6) He shan store the byproduct ma- an u e . . . . .. . .. . .. . . . . . . . . Is% cation (3) neandapplicar Welfare [t submits complete terial, except when in use, in the shielded (111) Skin of whole body............. 7% information as to the labeling to be af-or a n ner p o ding (15) He shnu supply a film badge, fixed to the container of the byproduct e 1-alent radiation protection. pocket chamber, or pocket dosimeter to, material which shall bear one of the fol-(7) He shall secure each cobalt 60 and shall require the use of such person. lowing statements, as appropriate: needle or tube against unauthorized re. nel monitoring equipment by, any in. (1) "This pharmaceutical may be dis-moval from its place of storage, dividual who is likely to regelte a radia. tributed to physicians under license ex-
- (8) He shall maintain, at each fa- tion dose in any one calendar quarter in emption of the U.S. Atomic Energy cility where the byproduct material is excess of 25 percent of the applicable Commission." (11) "This pharmaceutical may be dis.
used, a calibrated and operable radiation values specified in subparagraph (14) of tributed to physicians pursuant to gen. survey instrument capable of measuring this aragraph eral ense 10 N R26 from 0.1 millirad per hour to 500 milli. (16) He shall make or cau.e to be Atomic Energy Commission.,d W M rads per hour of the radiations emitted made such radiation surveys as may be (4) The labels and brochures which by the genersUy licensed material. (9) He shan calibrate or have cali- necessary for him to comply with the accompany each package of byproduct brated each survey instrument at inter, provisions of this section. material: vals not to exceed alz (6) months and (1*l) He shall report by telephone or (D Contain adequate information as after each servicing. telegraph to the Director, Division of to precautions to be observed in han-
/ (10) He shall conduct after each use Licensing and Regulation, immediately dling and storing such byproduct a physical inventory of the cobalt 60 after its occurrence becomes known to materials;
~ '
_ ... = . . ---- ~ ~ J a k I -
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e b l (11) Include o copy of I 30.11 or Regulation, t.Il transf:rs gf such cobalt 8 30.26 as appropriate. 60 needles tr tubes to physicians sm-erally licensed under I 30.26(a). Such l
- 5. A new paragraph (1) is added to report shallidentify each generallicensee 6 30.24 to read as follows: by name and address and registration _4 (1) Nonsfacture of cobalt do, needles number: date of transfer; the type of '
or tabes for distribution to persons gen- cobalt 60 needles or tubes transferred erollar licensed under i 30.28 An appli- and the amount in millicuries of by- i- M cation for a specific license to manufac- product material contained in the ,a ture, import, label, package and distrib- needles or tubes. The report shall be ute cobalt 60 needles or tubes for use submitted within 10 days after the end
- by physicians generally licensed under of each calendar month in which such I 30.26 will not be approved unless: needle or tube is transferred to a gen.
(1) The applicant satisfies the gen- erally licensed physician, (2) Shall furnish to each general 11- L eral requirementa specified in i 30.23. (2) The applicant submits sufBeient censee to whom he transfers such cobalt j f information relating to the design, man- 60 needle or tube, ufacture, prototype testing and quality (1) A copy of the generallicense estab-control procedures for the cobalt 60 lished by I 30.28. i needles or tubes, to provide reasonable (ID A certificate of calibration which j assurance that the byproduct material shallinclude a statement that the needle a contained in the needle or tube under or tube has been tested and shows no normal conditions of use will not be detectable leakage of radioactive mate-rial to the exterior of the needle or tube, likely to escape therefrom. a statement of the dosage rate, and the (3) The applicant submits sufBelent name of the manufacturer." information relating to the storage con-tainer for the cobalt 60 needles or tubes, Dated at Germantown, Md.. this 10th l to provide reasonable assurance that: day of January 1962. I (D No person would be likely to re. For the Atomic Energy Commission. ceive a radiation exposure to a major l portion of his body in excess of 0.5 rem Wooorono B. McCoot.. . Secretary. in a year under ordinary circumstances ofstorage. IP R. Doc. 62-517; Filed. Jan. 17. 1962; (11) The storage container may be a:45 a m 1 kept locked. (4) The applicant submita complete information as to the labeling to be af-fixed to the storage container for the cobalt 60 necdles or tubes, which shall contain adequate information for the _ safe use or manipulation of the co-balt 60 needle or tube and shall bear the following statement: "This device , may be distributed to physicians pursu-ant to general license 10 CFR 30.26 of the US. Atomic Energy Commission." (5) In describing the label or labels to be aflized to the storage container for the cobalt 60 needles or tubes, the applicant shall separately indicate those instructions and precautions which are necessary to assure safe use of the by-product material. (6) Cobalt 60 needles or tubes will be comprised of cobalt 60 wire hermetically sealed within stainless steel tubing, or , within other metal or alloy having i equivalent properties of resistance to I corrosion and abrasion. (7) Each cobalt 60 needle or tube will: i (D Be subjected to suitable tests to ! detect possible leakage of byproduct material. (iD Be individually calibrated. (11D Have engraved upon it a code marking which indicates the linear in. ' tensity and number of millicuries for such needle or tube.
$ 30.32 [ Amendment]
- 6. A new paragraph (g) is added to 130.32 to read as follows:
(g) Each licensee authorised under i 30.24(D to manufacture, import, - label, package, and distribute cobalt 60 - needles or tubes to generally licensed ,__, physicians: (1) Shall report in duplicate to the ' Director, Division of Licensing and _ 6- oro s asses l
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U. S. ATOMIC ENERGY COMMISSION PART 30 (Reprint from 29 Federal Register, 7393, June 6,1964) manufactured, packaged, and labeled Possession hmits and limitations on stor. gg @@h h hh under "new drug applications" approved age and transfer of the radiopharma. by the Food and Drug Administration ceutical. The possession hmat for cobalt I I 10 CFR Port 30 ] or a license for a biologic product issued 58 and cobalt 60 under the general 11-by the Secretary, Department of IIealth, cense, however, is 5 microcuries whereas BYPRODUCT MATERIALS Education, and Welfare. . 10 microcuries s as specified in the Janu. The proposed i 30.11(d)(2) published ary 18,1962, proposal. An additional
- Proposed Generog (; cense yer January 18.1962, limited the uses under limitation has been added that the mdlo.
Diognostic Uses the exemption to the uses described in pharmaceuticals may not be adminis. On January 18, 1962, the Commission the label or brochure accompanying the tered to a woman known to be pregnant published in the Ftunut Rzerstra (27 package. This label or brochure would or to a person under 18 years of age. The F.R. 531) a proposed amendment of its be approved by the FDA (or USPIIS) and general licensee would be exempt from regulation, Licensing of Byproduct Ma. the AEC, and would include only a the requirements of 10 CFR 20 with re. terial".10 CFR Part 30, which would limited number of well estabushed, non. spect to the byproduct materials covered exempt or generally license specified investigational uses of pharmaceuticals by the general license. quantitles of certain byproduct materials containing the specified radioisotopes. The Atomic Energy Commission will for use by physicians. Under the provisions of the proposed work with the Food and Drug Adminis. l The proposed rule published on Jan. exemption published January 18, 1962, tration and the Department of Health, l
' uary 18,1962, included three basic pro. the pharmaceutical containing radio. Education, and Welf are on their labehng 1 posals. active material would be packaced in in. requirements for the generally licensed (a) ' Exemption of the use for diagnos. dividual cabbrated doses ready for ad. radiophannaceuticals and the radiation tic purposes by physicians of iodine 131, ministration. No processing by the safety information to be included in the cobalt 58, cobalt 60, and Chromium 51 in physician would be required. The pro. brochures which accompany the gener.
specified forms and relatively small posed exemption would require that the ally licensed radiopharmaceuticals. quantities; radiopharmaceutical be stored, until ad. Statemenf of radiation safety consid. (b) A general license for the medica] ministered in the onginal shipping con. erctions. Under the provisions of the use by physicians of todine 131 and phos. tainer or a container providing equiva. proposed general license in i 30.29 the phorus 32 in specified forms and hmited lent radiation protection. The mari. pharmaceutical containing radioactive quantities su!Betent for certain thera. mum quantities of radioactive material material would be packaged !n individ-peutic and clagnostic purposes; which a physician may possess at any one ual calibrated doses ready for adminis. (c) A general license for the medical time under the proposed exemption as tration. No processing by the physicign use by physicians of cobalt 60 contained published on January 18,1962, would be is required. The radioisotopes would be in needles or tubes designed and manu. 200 microcuries of lodine 131,10 micro.r used only by physicians and for medical j factured for interstitial or intracavitary curies of cobalt 58,10 microcuries of co.' diagnosis. We proposed general license i use. balt 60, and 200 microcuries of chromium requires that the rad!oactive material be In reference to the propcsed amend. 51. stored, until administered,in the original
! ment the Commission has received nu. He proposed amendment set forth be. shipping container or a container pro- l j merous comments from ilcensees, medi. Iow follows closely the portion of the no. viding equivalent radiation protection.
I tice of proposed rule making published The maximum quantity of radioactive cal societies, and other interested per- January 18,1962, which pertained to the material which a physician may possess aons. A considerable number of com- exemption of microcurie levels of certain at any one time under the proposed gen. ments were favorable to the proposed byproduct materials for diagnostic uses, eral license is 200 microcuries of lodine t amendment. A substantial number of The prtmary di!!erence from the earlier 131; 5 microcuries of cobalt 58; 5 micro-
; the letters received by the Commt= ton, proposal is that this amendment would curies of cobalt 60; and 200 microcuries homever, opposed the proposed amend- establish a general license rather than of chromium 51.
3 ment, parucularly the proposed 5 30.24 The radiation doses received by phys!- I which would establish a general license an exempuon. The physician would be chns or technicians in the admints-
} for therapeutic quantities of iodine 131 required to register with thern=mwlon tration and handling of diagnostic doses
! and phosphorus 32. A major basis for prior to receiving byproduct material un- of radioisotopes which would be generally i such objection is the view that medical der the general license, ne general li- licensed are quite small. Interstate i schools at this time do not include as a cense expressly limits use of the specified Commerce Commlulon regulations spec.
part of their required curricula courres materials as to chemical form of the by- ify that the radiation on the surface of on the clinical uses of radiopharmaceuti- product material, the drug which is la- a shipping container shall not exceed 200 cals and their safe handling. beled by*the radioactive material, and
, A number of persons offering comments the authorized use of the radiopharma- milliroentgens per hour (mr/hr) and at i suggested that the dingnostic provisions ceutical. For example, there are only one meter from the contained radioactive l were less subject to significant contro- two authorized uses under the general material shall not exceed 10 mr/hr. In versy than the proposed general licenses license for lodine 131. Included are (a) practice, the radiation levels about con-for therapy and recommended that the todine 131 as iodinated Buman serum al- tainers for diagnostic doses of isotopes Camminian proceed separately with the bumin (IHSA) for determinations of . are much below these levels. The radio-proposed exemption for diagnostic uses in blood and blood plasma volume; and (b) ' isotope container is handled by physi-l the rule making procedure. Comments todine 131 as sodium todide for measure- clans and technicians for very short pe-
) directed specifically to the proposed ex- ment of thyroid uptake. riods of time. Remote handling equip. emptions for diagnostic quantities of The authorized use of cobalt 58 or co- Inent is unnecessary. The exposure rate lodine 131, cobalt 58, cobalt 60, and balt 60 under the general license is for at a distance of I centimeter from a point chromium 51 were generally favorable. the measurement of intestinal absorp. source of 200 microcuries of lodine 131 he pharmaceuticals which were pro i tion of cyanocobalamin. The author- is about 440 milliroentgen / hour or 7.3 posed for exemption contain microcurie ized use for chromium 51 as sodium ra- milliroentgen / minute. A bottle of iodine levels of radioactivity and are subject to diochromate is for determination of red 131 capsules is not a point source, but control by the Food and Drug Adminis- blood cell volumes and studies of red the dose rate close to it would be of this tration or the Department of Health, blood cell survival time, order of magnitude. Education, and Welfare. The proposed The lisaltauona set forth in the Janu- The dose rates from the other ding-exempuon would apply only to pharma- ary 18,1962, proposal are red. mined in this nosuc radioisotopes which would be gen- lI ceuucals containing lodine 131, oobalt34, prnpa==t amendmen t. '1he include erally licensed are much lower than for l cobalt 60, and chromium 51 which are ! y __- - __ p
t s The general license is a arthwhil2 step (1) Name and address of the regis. lodine 131$ Thy caposure rates Ct ont * ,' centlaster irom point sources cf 5 micro. - to7 erd making useful radt: isotope tech- trant; (2) A statement that the registrant is curle6 of cobalt 54,5 microcuries of co. niquea av;il:ble to the medical pro- a duly licensed physician Cuthorised to
- b balt 80 cnd 200 microcuries of chromium fession. Only limited diagnostic pmgrams are dispense drugs in the practice of medi.
51 tre 30 mil 11 roentgen / hour, 64 m!Hl. possible under the general license. The cine, and specifying the State in which i roentgen / hour and 80 miniroentgen/ specified possession limits are relatively such license is valid; and respectively, (3) A statement that the registrut h;ur'CFR 10 Part 20 specifies that the hands low and only a few forms of radio-af radi: Mon workers may be exposed to pharmaceuticals and authorized uses are considers that he has appropriate radia-18% rims per quarter or an average dose included. A specific license will be re- tion measuring instruments to carry out 1 cf 1440 millfrems per week. If an indi- quired for those physicians who need a the diagnostic procedures for which he viduit cere exposed only through the j higher possession level, wish to employ proposes to use byproduct material J other raidopharmaceuticals, or propose under the generallicense of 10 CFR 30.29 hindling of 200 microcuries of iodme 131* to use the specified radiopharmaceuticals and that he is competent in the use of - he could ' handle the cup or bottle for purposes other than those authorized such instruments. contdning the radioisotope ng =198 under the generallicense. (c) A physician who receives, possesses t Pwsuant M the Atode Energy Act of or uses a pharmaceutical containing by- t minutes each week Mthout 'di 1954, as amended, and the Administra- product material pursuant to the general '
'th7 limiting hand dose estab ed tive Procedure Act of 1946, notice is here- license established by paragraph (a) of 10 CFR Part 20. In practice diagnostic by given that adoption of the following this section shall comply with the i doses Cf radioisotopes are handled only amendments to Part 30 is contemplated. fonowing: 4 1 cr 2 minutes during each administra- Allintnested persons who desire 6 sub- (1) He shall not possess at any one tl:n. The hand doses received by physi- mit written comments or suggestions in time, pursuant to the general license in .- i l ci3s end technicians from handling e nnection with the proposed amnd- paragraph (a) of this section, more than: 3 diagnostic doses of radioisotopes are ments should send them to the Secretary. (i) 200 microcuries of iodine 131, !
smin. United States Atomic Energy Commis- (ii) 5 microcuries of cobalt 58. , Tha trhole body exposures to medical sion, Washington, D C. 20545, within (iii) 5 microcuries of cobalt 60, and 4 personnel are likewise small from the sxy sys af e u n 2@ microcuries of chromium SL handling of these doses. The exposure notice in the FEDERAL RecIstra. Com- (2) He shall not receive, possess, or d rage Ot one foot from 200 microcurses ments received after that period will be use the pharmaceutical pursuant to the 1 Cf unshielded lodine 131,5 m!crocurtes of considered if it is practicable to do so. general license in paragraph (a) of this T unshielded cobalt 58.5 microcuries of un- but assurance of consideration cannot be section, unless the following statement, k ah!Ilded cobalt 60 and 200 microcuries given except as to comments filed within or a substantially similar statement t Cf unshielded chromium 51 are 0.5 milli- the period specified. which contains the information called roentgen / hour. 0.03 milljroentgen/ hour, 1, A new I 30.29 is added to read as for in the following statement, appears on the label affixed to the container or N 0.07 milliroentgen / hour and 0.09 milli. follows: appears in the lesfiet or brochure which roentaen/h o'u r. respectively. Doses 6 30.29 General license for medical use accompanies the package: ,;l chich trould be received by physicians of certain quantities of byproduct cnd technielans working in radioisotope material. nis radioacuve drug may be received, pos- 4 used only by phratetans. Ita t*I diagnostic programs under the general (a) A general Ucense is Meh issued , sensed andneelpt, possesston, use and transfer are sub-license would be so small that personnel to any physician to receive, posses 8, ' ject to the regulauona and a general treense monitoring equipment would not be re- transfer, or use for any of the following ! of the United States Atomic Energy commis-i quired and they would be exempt from stated diagnostic uses,in accordance with ston or of a state with which the com=wton has entered into an agreement for the exer. the requirements of 10 CFR Part 20. the provisions of paragraphs (b), (c), etae or agulatory authority. Becmae of the Icw levels of radiation and (d) of this section, the following ' involved and the manner in which diag- byproduct materials in capsules, dis- M Io E aduract'Ee'rY nostic radioisotopes are used, there is posable syringes or other forms of pre- (3) He shall store the pharmaceutical no need to specify minimum training or packaged individualdones; unul administered in the original ship- .. experience requirements for physicians. m Iodine 131 as sodium Jodine n o oviding A radiiti:n survey meter is not needed. (NaI'") for measurement of thyroid up- p In the case of accidental spills, which are (4) He shall use the pharmaceutical infrequent, the radiation instrumenta- I dine 131 as lodinated human only for the uses authortsed by para. tion used by the licensee to interpret re- serum albumin (IHSA) for determina. graph (a) of this soeuon-tions of blood and blood plasma volume (5) He shall not edelnister the phar-sults of the diagnosuc teste can be used to check for cors**minauon. There is (3) Cobalt 58 for the measurement of mmeuuoal 2 a woman with hed little likelihood that the radioisotopes intesuaal absorption of cyhfa=fn, pregnancy'or to a person under le years (4) Cobalt 80 for the measunsasat of et age. wul be ingested or inhalad by amanteed 2
.L int ==tinal absorption of eyanaaah8"""*"
- personnel since no processing of thp (S) He shall not transfer the byprod-
-l d6an=aeg== wG1 be involved. Enee (lag- (5) Chromanum 51 as sodium radio- not mawdal M a parean who is not nostic radioisotopes are ordered by phy- ehromate for deWea of nd Nood authorised to reestve it pursuant to a seelans only as needed, very little of the cell volumes and studies of red blood cell ! Ucense issued by the rin-meassaan or an matadal is Atta==d of as waste. survival time' Conclusions. In view of the Ilmited use, (b) No physician shall receive, possess, than ; agreement in the unopened State,labeled or in any manner other shipping scope of the generallicense, the low lev- or transfer byproduct material pur- container as received from the supplier, els of radiation involved, the manner in suant to the general license established except by administering it to a pauent.
a which diagnostic radioisotopes are used, by paragraph (a) of th!s section until he (d) "Ite registrant pamaammine or using # and the f act that no processing of the has filed Form AEC-482, ** Registration byproduct material under the general } '% radiopharmaceuucal by the physician Certifkate-Medical Use of Byproduct would be required, the Commianton con- Material Under General License with , license of paragraph (a) of this sectionshall report in dup s&ders that no significant quesuon of the Director Division of Materials Li 4 of Materials Licensing, any radittion safety is presented by the pro- censing, United States Atomic Energy : Divisionchanges in the information furnished by D.C., posed general license. Cneminalon, Washington, 20545, him in the " Registration Certificate-Purthir, the reneral license would lend and received from the Comminafon a Medical Use of Byprod,,uct Materia! Un-validated copy of the Form AEC-482 with g 1mpetus to the use of certain well estab- N82. 11 abed, useful, diagnost6c applications of registrapon ntunber assigned. The The report shall be submitted within 30 radioisotopes which have been empnoyed registrant shall furnish on Form AE- days after the efective date of such % over 3 period of time without presenung 482 the foDowing information and such change- , j any signinennt r=tiattaa safety prah"' other informauon as may be required by thatform: Imme P [ ,
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_,_ _ ._, _ m 7 is E o t.,a (e) Any person using byproduct ma. terial pursuant to the general laense of
- paragraph (a) of this section is exempt from the requirements of Part 20 of this chapter with respect to the byproduct materials covered by the generallicense. j
- 2. A new pvagraph (k) is added to I 30.24 to rea.d as follows:
I $ 30.24 Special requiremente for I..u. ance of speciGe liceneca. e e o e e (k> Manufacture and distribution of bntproduct materials for medical use un.
. der peneral license. An application for
' a spectSc license to distribute byproduct l
material for use by physicians under the i generallicense of I 30.29 will be approved i if: l (1) The applicant satis $es the general i requirements spec 18ed in i 30.231 (2) The applicant submits evidence that the byproduct material is to be manufactured, labeled, and packaged in accordance with a new drug application
! which the Commissioner of Food and
! Drugs, Fbod and Drug Administration, i has approved, or in accordance with a license for a biologic product issued by j
the Secretary, Department of Health, l Education, and Welfare: I (3) 'Ihe following statement, or a sub. stantially similar statement which con. tains the information called for in the following statement, appears on the label t" afRxed to the container or appears in the leaflet or brochure which accompanies J the package: This radioactive drug may be received, paamaaaad and used only by physicians. Its receipt, possonston, use and transfer are sub. ject to the regulations and a generallicense of the UA. Atomic Energy Commlaston or of a State with which the Commission has entered into an agreement for the exercise of regulatory authority. (Name'of Manufacturer) e e e e e Dated at Washington, D.C., this 12th day of May 1964. For the Atomic Energy Cammianlon. W. B. McCoot, Secretary to the Commission. [F.R. Doc. S H 000. FUed June S. 1984: 3:48 am.] l
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L 1 1 1 1 U. S. ATOMIC ENERGY CO MISSION PART 30 L / sg g f3 (Reprint frorn 29 Federal Register, 9529, July 14 1964) f j
.- 4, Title IO-ATOMIC DGGY !
j Chapter B-Atomic Energy 1 Commission 4 PART 30-LICENSING OF BYPRODUCT 4 i MATERIAL q ; I jj Revocation of General Ucense for Ex-port of Medicinals and Similaritems 1 to Cuba
]
nis amendment to 10 CFTL Part 30 la designed to conform the Commission's d regulations for the export of byproduct - material to the export regulatJons of the ' U S. Department of Commerce sith re-spect to exports to Cuba. The Depart- ] ment revoked its general licenses for ex- b. port of food and Enedicinals to Cuba A effective May 14. 1964 It stated that i shipments were not precluded. but that ' the Department s1shed te be informed of ' all Intended trade with Cuba and there-by be in a position to act according to the national interests of the United States. ne Commt.ssion's regulation,130 33fe) j*J of 10 CFTl Part 30. provides a general lleense for any licensee to export to Cuba j JJ byproduct material covered by his ll-cense to the extent that the byproduct . ']{ material is contained in medicinals or ' pharmaceutical preparattons or in de-p, p j-vices, applicators or appliances designed i for use in medical diagnosis or therapy.' , ne foDowing amendtnent revokes that general license. Hereaf ter, appiteations will have to be filed with the Commission for a specific 11 cense to export any such medicinals or similar items containing byproduct material to Cuba. , Inasmuch as this amendment involves .4 the foreign affairs funettons of the United States, the Commtmaion has found '!
- that general nottee of proposed rule mak-ing and public procedure thereon are contrary to the public interest, and that j good cause exists why this amendment j abould be made effective upon publica-
tjon in the Pretaat RactsTra. - , Accordingly, pursuant to the A Energy Act of 1954, as amended, an e i4 Administrative Procedure Act of IM6, paragraph (c) _of I 30.33, Export of by- } product matermi, is revoked, effeettve n upon publication in the Papuaat Rectsvra. , j , (Sec 82, 68 6 tat. 935*. 42 US C. 2It2. sec. W1. 1, g. 83 Stat b48. 42 U.S C 220s) , Dated at Washington, D.C., this 29th day of June 1964. .
*The ammuset h to reserecend to W. !
produrs matertaJ hartag na atomne summher ' rrom 3to N. For the Atomic Energy Nh # W. B. McCooL. l y Secretary to the Comunissica. [FJt. Dan ee-eMo. Pued. July ts. ism: [- -t , s.4s am i d
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(Reprint from the Federal Register, 6575, May 13, 1965)
^
I Faom the point of view of ex ennal ex. a pesson under 18 years of an The 6;cn-Ti tle 10-AT05pCa ENERGY pesure. the dose rate nea, a ga .n ,eu,ce etai hunwe is exempt faom tu acquire-
;. will be about a factor of I less for I-125 ments of 10 CFR Part 20 with respect to
, Chopier I-Atom.ic Energy than for I-131. More imprtantly, the byproduct matestals covered by the Commission however, the radiation enersies emitted general license.
The radiopharmaceutical manufac. PART 30-LICENSING OF BYPRODUCT by I-125 are such that it is cons.derably
' easier to shield, and under com) arable turer is required to obtain a specific 11 MATERIAL handline conditions, including spills, cense authorizing distribution of radio-General License for Diagnostic Uses 1-125 would be expected to result in pharmaceuticals for use under the acn-considerably lower external exposures. cral license. The manufacturer must
} of Certain BYPtoduct Materials Comparable internal radiation dose to submit evidence that the radiopharma-
! On June 6.1964, the Commission pub- the thyroid would be expected frc'n I-125 ceutical is to be manufactuacd. labeled.
l' lished in the FEDERAI. RtctsTen (29 F.R. as from I-131 for a given amount of and packaged under a new daug appil-
'i3936 a proposed amendment of its reg- activity in the form of iodine. In other cation apptoved by the Foof t and Dru::
l' ulation. " Licensing of Dyproduct Mate. forms, the I-125 would be expected to Administration or a license for a bio-rial",10 CFR Part 30. which would gen- result in notably less exposure per unit lo-ic product issued by the Depastment crally license specified quantities and of activity administered than I-131.since of Health, Education.and Wclfare.
. forms of iodine 131 cobalt 58. cobalt 60 the biological half-lives in the body are The Atomic Energy Commission v.ill 1 and chromium 51 for use by physicians controlling and these are independent of wonk with the Food and Drug Adminis-foi diagnostic purposes. the isotope in'volved. tration and the Depattment of Health.
I' In reference to the proposed amend. A major advantage of the use of I-125 Education, and Welfare on thcir label-ment the Commission has received nu- over I-131 is that, with appropriate in- ing requirements for the gencially 11-merous comments from licensees. med- strumentation, sensitivity can be im- censed radiopharmaceuticals and the
; leal societies, and other interested per- proved, leading to possible reductions in radiation safety information to bc in-sons. The majority of comments were the amount of activity required for a cluded in the brochurcs which accom-favorable to the proposed amendment al- given medical test. Hence, it is likely pany the cencrally licensed ladiophap though a number of the letters received that there will be some reduction in maceuticals.
.by the Commission opposed the amend- future patient exposures for a given During the f) st few years the concial ment. Several specine comments sun- medical test resulting from the use of I cense as in effect the Commission ulli gested that the scope of the general li- I-125 as opposed to I-131. conduct a study to evaluate the effects cen'sc be broadened or that certain limi- In conclusion, there is reason to be- of the general license. Upon the basis
} tations of the generallicense be liberal- lieve that I-125 may be expected in the of this expellence the Commission will j iztd. It was suggested, for example, that future to result in some reduction in reevaluate the general license and deter-the proposed possession limits for the exposure. With proper storage. IHSA- mine whether it should be contmued,
- generally licensed byproduct materials I-125 has a longer useful shelf life than withdrawn, or expanded to include addi-
! be increased and that todinated fats and IHSA-I-131. tional materials and uses.
- fatty acids for gastrointestinal function Except for the addition of IHSA-I-125 In view of the 1 mated scope of the studies be added to the generallicense. to the general license, the text of the , general license, the low levels of radia, The Commission has given careful amendment is the same as the proposed tion involved, the manner in which cons'ideration to all comments received general license pubhshed on June 6. diagnostic radioisotopes are used, and the and has concluded that the proposed 1964. The physician is required to reg- fact that no processing of the radio-generallicense should be pubitshed as an ister with the Commission prior to re- pharmaceutical by the physician would effective rule substantially in the form ceiving byproduct material under the be required, the Commission considers published on June 6.1964. There is one general license. The general license ex. that no significant question of radiation difference, however, in the amendment pressly limits use of the specined mate- safety is presented by the proposed gen. set forth below from the proposed rule rials as to chemical form of the byproduct cral license, published on June 6,1964. Iodine 125 material, the drug which is labeled by It is recognized that only hmited diag-as lodinated human serum albumin the radioactive material, and the au- nostic programs are possible under the (IHSA) has been added to the general thorized use of the radiopharmaceutical. general license. The specified posses-license for determinations of blood and For example, there are only two author- sion limits,of are relatively low and only a blood plasma volume. A physician is ized uses under the general license for few forms radiopharmaceuticals and authorized to possess at any one time lodine 131: (a) Iodine 131'as todinated authonzed uses are meluded. A specific l under the general license not more than human serum albumin (IHSA) for de- license will be required for those physi- j 200 microcuries of iodine 125. terminations of blood and blood plasma clans who need h higher possession level. A statement of radiation safety con- volume: and (b) iodine 131 'as sodmm wish to employ other radiophatmaceutt-siderations for lodine 131, cobalt 58, co- todide for measu*rement of thyroid up- cals.or propose to use the specified l adio-balt 60, and chromium 51 was included take. The authorized use of iodine 125, pharmaceuticals for purposes other than
. In the notlee of proposed rule making as iodinated human serum albumin is for those authorked under the general published on June 6,1964. The follow- determinations of blood and blood plasma D"*
ing is a statement of radiation safety volume. Pursuant to the Atomic Enernt Act of considerations for lodine 125. The authorized use of cobalt 58 or co 1 1954. as amended, and the Administra- > Statement of radiation safety con- balt 60 under the general license is for \tiveProcedure Act of 1946. the following siderations for iodine 125. Iodine 125, " the measurement of intestinal absorp '"0.',ndment of ofTitle 10, Chapter I, Part as lodinated human serum albumin, is tion of cyanocobalamin. The authorized 1 3 Licensing . Byproduct Material." currently produced and distributed un- use for chromium 51 as sodium radio jls published as a document subject to der s product license issued by the Secre- chromate is for determination of red icodification to be effective thirty (30s tary, Department of Health. Education. blood cell volumes and studies of red days after publication in the Frcrnt. and Welfare. IHSA-I-125 has a useful blood cell survival time. Rrolsh shelf life substantially greater than the The limitations set forth in the earlier 1. A new I 30.29 is added to read as equivalent product IHSA-I-131. proposal are retained in this amend follows: Iodine 125 has a considerably longer ment. These include possession limits Cencral lisen c for nicdical' u.c and limitations on storage and transfer 6 30.29
]5s physical half-life (60 days) than I-131 (8 days), but the energy liberated per of the radiopharmaceutical. The radio-of cerimin qmntiaire of hyproduce material.
disintegration is about a factor of 10 pharmaceutical must be in the form of (a) A general.oc, .se ts heleby issued less for I-125 than for I-131. In gen- capsules, disposable syringes, or other to any physki nt 13 receive, possess.
. eral, the latter consideration tends to forms of prepackaged individual doses.
Radiopharmaceuticals used under the t{a e make I-125 a less algnificant source of radiation exposure than I-131, per unit general license may not be administered sh an[o[ t e .
, ,the provisions of paragraphs (b), (c).
of activity, to a woman lu>own to be pregnant or to and (d) of this section, the following l n-~-~ _ __ _ _ 1 _- ,, _
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.s* A, byproduct matcrials in ca; mules, disposa- (1) 200 microcuries of lodine 131 ry a$th1rts '
til) 200 microcuries of lodine 136, fe,$**,*m,"re fr la b'e syr;nges or other forms of prepack- . aged indivicual ch.c.- ( 111 ) 5 microcuries of cobalt 58. - c.s scdium lodide (iv) 5 microcuries of cobalt 60, and (Name of manuf acturer) sl> Iodinc 131 (v) 200 microcaries of chromium 51. (Bec. tel, es stat. 04s; 42 U.S.C. 2201) : %e-map), for muurement of thyrcid (2) He shall store the pharmaceutical Dated at Washington, D.C., this 30th upts:?: (2) lodine 131 as lodinated human until administered in the original ship- day of April 1965. ; sertun allumin (IUSA) for determina- ping container or a container providing
- For the Atomic Energy Commission.
tions of bic,od and blood plasma volume; equivalent (3) He shall radiation protection; use the pharmaceutical (33 Iodine 125 as lodinated human W. B, McCoor., serum albumin (DISA) for determina- only for the uses authorized by paragraph Secretary. .I ti:ns of blood and blood plasma volumr; (a) (4) of this section; I He shall not administer the phar. IFA Doc. es-octs: Piled, May 12, toes; ' (4i Cobalt 58 for the measurement of s:45 a.m.) intestinal absorption of cyanocobalamin; maceutical to a woman with confirmed (5) Cobalt 60 for the measurement of pregnancy or to a person under 18 years ' intestinal absorption of cyanocobalamin; of age; (5) He shall not transfer the byprod- d (6) Chromium 51 as sodium radio- I chromcte for determination of red blood uct material to a person who is not au. cell volumes and studies of red blood cellcense thorized to receive $ issued by theitCommission pursuant to aor11- an < survinl time, agreement State, or in any manner other I Nort: Section 3024(k) requires manufac- than in the unopened, labeled shipping 4 9
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turers .of radiopharmaceuticale which are und;r the general lleense in this paragraph container as received itfrom the suDElier'. except by administering to a patient s to include the following statement in the (d) The registrant possessing or using j tabel t,fr.aed to the container or in the byproduct material under the general lenfiet or brochure which accompanies the license of paragraph (a) shall report in Q( radt; pharmaceutical: ' m radioactive drug may be received, duplicate to the Director, Division of possessed. and used only by physic 1ana 11-Materials Ucensing, any changes in the cansed to dispense drugs in the practice of .i.nformationCertificate-Medical Registration furnished by him inUse the mMicine. Its receipt, possession, use, and s transfir are subject to the regulations and of Byproduct Material Under General n genral license of the UA. Atomic Energy Ucensez Form AEC-4a2. . The report Commisalon or of a State with which the shall be submitted within 30 days after . Conuntsalon has entered into an agreement the effective date of such change. for the exercise et regulatory authority.
,1
- = ---- (e) Any person using byproduct ma- Y
---=(Name of manufacturer) terial pursuant to the general license of paragraph (a) of this section is exempt (b) No physician shall receive, pos- from the requirements of Part 20 of this i.
sess, use, or transf er byproduct material chapter with respect to the byproduct J, pursuant to the general license estab- materials covered by the general license. 11shed by paragraph (a) of this section 2. A new paragraph (k) is added to until he has filed Fbrm AEO-482, " Reg-1str tton Certificate-MedicalUse of By- 130.24 to read as follows: product Material U nder. General Ucense" $ 30.24 Special requirements for Isou-with the Director, Division of Materials ance of speciallicenses. Ucensing. U.S. Atomic Energy Commis- * * * *
- sion, Washinr: ton, D.C., 20545, and re- (k) Manufacture and distribution of ceived from the Commission a validated byproduct materials for medical use un-copy of the Form AEC-482 with regis- der general license. An application for tratirn number assigned. ' Die registrant a specific license to distribute byproduct sha!! furnish on Form AEC-482 the fol- material for use by physicians under the '
lowlag information and such other in- generallicense of i 30.29 will be approved 1:rmation as may be required by that if: - firm: (1) the applicant satistles the general (1) Name and address of the regis- requirements specified in i 30.23; trant; (2) the applicant submits evidence (2) A statement that the registrant is that the byproduct materialis to be man- ' o duly licensed physician authorized to ufactured, labeled, and packaged in ac-dispense drugs in the practice of medt- oordance with a new drug application 4 cine, and specifying the license number which, the Commissioner of Food and and the State in which such license is Drugs, Food and Drug Administration. valld; and . has approved, or in accordance with a (3) A statement that the registrant license for a biologic product issued by has appropriate radiation measuring in- the Secretary,- Department of Health, i struments to carry out the diagnostic Education, and, Welfare; procedures for which he proposes to use (3) the following statement, or a sub-byproduct material under the general stantially similar statement which con- : license of 10 CFR 30.29 and that he is tains the information calleil for in the ; competent in the use of such instruments, following statement, appears on the labei , (c) A physician who receives, pos- afnxed to the container or appears in the J
. sesses, or uses a pharmaceutical contain- leaflet or brochure which accompanies ing byproduct material pursuant to the the package:
generallicense established by paragraph 'rtis radioactive drug may be received, W of this section shall comply with "N the following: possessed, and used only by phystelans j licensed to dispense drugs in the practice (1) He shall not possess at any one of medicine. Ita recalpt, possession, use, and > , time, pursuant to the general license in transrer are subject to the regulations and , parr.gTaph (a) of this section, more a general noen.as of the 172. Ateente Energy
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. Published in 30 Federar Register 8185, June 26, 1965 PART1 30
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Rules and'Regukitions
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' gw jg gg gg items conhtning byproduct material for reflect the amendments of Il 30.12. 30.21 distribution to persons exempted under (d),30.24(j), and 30.24(m) which were Part 30 - or generally licensed under published in the Panamaz. RxcIsvam on f Chapter I-Atomic Energy Parts 31 or 35. March 13.1965, and became effective >
- Commission Part 33-8pecific Ucenses of Broad April 12,1965.
Scope for Byproduct Material, ' Itis 4. The text of I 30.14 (30.9 of the prea-LICENSING OF BYPRODUCT part includes proMalons SWHesble to ent regulation) has been revised to re-MATERIAL licenses for multiple quantities and types flect the amendments of I 30.9 which a l On December 17,1964, the Cnmmiainn of byproduct material under which ac- were published in the PanzaAI, Raatsvam issued for public comment (29 P.R. tivities involving the use of FJproduct on April 3,1965, to be effective May 3 .i '
' 17915) a proposed ramhtion of its material in processing for distribution 1965. '
regulations- "Ucensing of Byproduct and reseanh and development are car- 5. 'Ihe text of !! 36.21 (30.33(b) of Material",10 CPR Part 30 and **Radia- ried on. the present regulation), has been revised tion Safety. Requirements for Radio. Part 34---Licenses for Radiography to reference the list of countries in - graphie Operations",10 CFR Part 31. and Radiation Safety Requhdants for I 36.50, Schedule A. rather than refer- ; Public comments indicate that the re. Radiographic Operations. This part in- encing "* *
- Cuba or countries or areas codification is a desirable step toward cludes the licensing requirements for use now or hereafter listed as Subgroup A ,
simplifying the format of these regula- of sealed sources in radiography (pre- countries or' destinations in 1371.3 of ' tions. Public comments also included sently set out in i 30.24 (g) of Part 30) the comprehensive export schedule of some additional suggestions for further and the radiation safety requirements the United States Department of Com - revisions of Parts 30 and 31. 'Ibese for persons holding licenses for radio- merce (15 CPR 371.3)." "Ihe term "Sub. suggested changes are being evaluated graphy now contained in Part 31. group A countries" is no longer used in by the C-mMion staff in conjunction Part 35---Human Uses of Byproduct the export regulations of the Department with other revisions which may be pub- Material. This part includes the special of Commerce. Other minor editorial 11shed at a later date. requirements for (1) licensing of in- changes have been made in Part 36. In the recodification, common require- dividual physicians for human use of by- 6. The text of Part 32 has been revised ments applicable to all byproduct mate- product material, (2) licensing of human to include 132.70 (30.24(k) of the present i rial licensing are retained in Part 30 use of byproduct material in sealed regulation) and Part 35 has been revised j while the remainder of the sections are sources and (3) licensing of human use to include 1 35.31 (30.29 of the present reloccted in proposed new parts desig. of byproduct material in institutions, regulation) . Il 30.24(k) and 30.29 were nnted Parts 31,' 32,33,34,35, and 36, each now set out in i 30.24 (a), (b) and (c) added to Part 30 by amendments which of which is applicable to certain classes of Part 30. It also includes a general were published in the PanzaAL RacIsna , or categories of uses or users of byproduct license for medical use of certain quan- on May 13,1965, to be effective June 12, i material. The requirements of Parts titles of byproduct material, now set out 1965. . The purpose of the recodification of 31-36 are in addition to those of Part 30 in iPart 30.29.36-Export and Import of By- Part 30 is to simplify and clarify the and other applicable provisions in the Commluton's regulations. product Material. This part includes format of the present regulations, so
'Ih) parts as recodified are: the requirements for specific licenses, the that persons subject to byproduct mate- i Part 30-Rules of General Applicability general licenses and other provisions re- rial licensing regulations can conven-to Licemtmr of Byproduct Material. ' Itis lating to export and import of byproduct tently use and understand them. No sub-stantive char.ges have been made and the part includes licensing and related pro. material. A cross-reference table has been requirements under the present regula-visions which apply generally to all by.
product material users, licensees or ap. placed at the end of each part to permit tions are not changed by the recodifica-plicanta for licenses, and includes such easy comparison of the old regulations tion. , maters as definitions; exemptions; gen. with the new. Parts 30-36 include the Pursuant to the Atomic Energy Act of tral requirements for specific licenses; substance of applicable rules or amend- 1954, as amended, and the Administrative commnr1 terms and conditions of 11 ments adopted and made effective during Procedure Act of 1948, the Commission censes, inspections, records and tests; the period between the date of the no- is amending Chapter I of 'I1tle 10 of the end enforcement procedures. tice (Dec.17,1964), and the effective date Code of Federal Regulations by deleting i of the rule set forth below. The text of Parta 30 and 31 and substituting there-Part 31-.-General Licenses for Certain the amendment set forth below is sub- for new Parts 30, 31, 32, 33, 34, 35, and Quantitles of Byproduct Material and stantially the same as the text of the 36 reading as hereinafter set forth. This Byproduct Material Contained in Cer. tajn Items. ' Itis part includes generaj proposed rule published on December 17, amendment is published as a document lic:nses for quantities of and items con. 1964, except forofthe following: subject to codification to be effective sixty taining byproduct material. It does nog 1. The text I 30.12 (t 30.6 of the (60) days after pubilcation in the FED- l I include general licenses for export and present regulation) has been revised to ERAL REGIsna. certain of the genera 111 censes for import, reflect the amendment of I 30.6 which (sec.1st es stat. 948: 42 U.s c. 2201) j which are set out in Part 36, or general was published in the PrornAL RecIstra Dated at Washington. D.C., this 27th on October 20, 1964, and became effec-licenses for medical uses which are set tive January 18,1965. day of May 1965. out in Part 35. 2. The text of I 31.5 (30.21(c) of the Part 32-8pecific Licenses to Manu- For the Atomic Energy Commission. facture, Distribute, or Import Exempted present regulation) and i 32.51 (30.24if) W. B. McCooL, f the present regulation) has been re-and Generally Licensed Items Containing Byproduct Material. This part includes vised to reflect the amendments of Secretary. ' 3o a 3 c th2 special requirements applicable to g Isna on PART 30-RULES OF GENERAL AP-ypN t mateItal r January 7,1965, and became effective PLICABILITY TO LICENSING OF BY-tri ute, or rt February 6,1965. PRODUCT MATERIAL
- 3. The text of I 30.16 (3012 of the O m m Pao W Ne ted in P S4 and Part 1 ta present regulation) and 131.7 (30.21td) 3 maaigned to General ucenses for certain of the present regulation) lI 32.15,32.16, 30.1 Purpose and scope.
Quantattee of Byproduct Material and By. 32.17, 32.40, 32.53, 32.54, 32.55, 32.56, soJ nesolution of conmet. product Materlat 02ntained in certain 32.101 (30.24 0 ) and 30.24 t m) of the soJ Acurtues requiring ncense. } Items. present regulation) has been revised to 30.4 peantuona. 8185
y li. 5. A' .
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_" ,1, p-" f36"'~ RULES AND DEGULAfl0NS' *' y,cr.. ,,' g;
\ - ' asc. ' (a) "Act" means the Atomic Energy graphic exposure devices, sealed sources so.s Interpretations. Act of 1964, including any ana=M==nts or related handung tools, or survey in- ';
so.s Communtontions. thereto; . Strutaents in radiography; - arm-rsons (b) Terms defined in secuon 11 of the (p) " Radiography" means the enamt- ' 30 11 anemptions from noensing Act shan have the sarne meaning when namn of h struhe' d materials by soils Persons using byproduct material un. used in the regulations in this part and nondestructive methods, utilizing sealed der certain Atonde Energy Commin. Parts 31-36 to the extent such terms are sources of byproduct materials; eson contracts. not speciScally deAned in this part; (q) "Research and development" 30.1s carr$ers. (c) " Agreement State" means any means (1) theoretical analysis, explora-3044 Exempt concentrations. State with which the Comminatart has tion, or experimentation; or (2) the ex-30.15 certain In=tnaus timepieces. 30.1e Inct nators installed in ano-entered into an effective agreement un- tension of investigauve findings and l der subsection 274b. of the Act. "Non- theories of a scient1Sc or technical na-i 39.3y wa og p, fen, son, agreement State" means any other State; ture into practical application for experi-
't 4 -
IC'"*" (d) " Byproduct material" means any mental and demonstrauon purposes,in-radioactive material (except special cluding the experimental production and
- 3031 Types et licenses. ,.
nuclear material) yielded in or made testing of models, devices, equipment, 30.32 Appucauons for spectac ucenses. radinactive by exposure to the radimiinn materials and proc *asen. "Research and 3o23 oeneralspecano seguirements un== for tasunnoe of incident to the process of producing or development" as used in this part and utilizing special nuclear material: Parts 31-36 does not include the internal (M T',',",,',,*",e n ,, ing on (e) "Camminainn" means the Atomic or external administration.of byproduct essense date et recostaosuon or Energy (Mmmiaminn and its duly author- material, or the radiation therefrom, to taus part. ised representatives; human beings; 30.36 Esptrauen at noenses. (f) " Curie" means that amount of (r) " Sealed source" means any by-30.37 Appuentions for renewal of ucenses- radionedve material which disintegrates product material that is encased in a s soms Appucations for amandmant or n- at the rate of 37 billion atoms per capsule designed to prevent leakage or 30_s9 Canet-lon action on app 11 cations to second.,. Government agency" means any escape of the byproduct material;
" " " ' " " ' " ' ) (s) " Source material" means source executive department, e=="an. Inde- material as denned in the regulations i==s Imersenoms aun Tzars pendent est ahlish ment, corporation, contained in Part 40 of this chapter; 30.51 ma-es. wholly or partly owned by the United (t) "Special nuclear mate 11al" means 30.52 Inspecu^"" 8tates of America whichis aninstrumen- special nuclear material as de8ned in 8038 D'**- tality of the United States, or any board, the regulations contained in Part 70 of E m aczuswr bureau. division, service, olBce, ollicer, this chapter; so.e1 md*=uon and revocation or n- authority, administ ration. or other estab- (u) " United States", when used in s ste2--mgh t re b product umhment in the execuuve branch of the geographical sense, includes aB territo-ms Government, ries and possessions of the United States.
so.es -vionatsons. (h) " Human use" means the internal the Canal Zone and Puerto Rico; , or external administration of byprodoct (v) "Utiffmation facility" means a utt- -
- ,acu m nas material, or the radiation therefrom, to lization facility as denned in the regula-sv.70 schedule A-Ezempt concentrations. human beings; tions contained in Part 50 of this W Avenourrv* 'th provisions of this Part so (1) " License", except where otherwise chapter. l tasuee under sec.1st, es stat. e4s: es Um.c. spec 18ed means a license for byproduct gg3 g,-", m _ _ ,
asol. Interpses or apply ases, el. es. les, los. material issued pursuant to the regula-es Stat. ses, sea see; es Us.C. alli, 3112. tions in this chapter;~ Except as anar.ineen, authorised by 3q asse, asas. For the purposes at sec. ass, se (p " Microcurie"_ ameans that amount the'Commtamaan in writing, no interpre- q 8 tat. ese; es Whc. 3573. I 3024(c) lasued of radioactive abaterial which disinte. tauon of the meaning of the regulations d
" under sec.181b ' se Stat. Des; es UE.C. 3201 (b) and It sosi and seis samed inneer sec. Erates at the rate of 37 thoueand atoms in this part and Parts 31-36 by any of- M#
ficer or employee of the Ca==waan
, let y,, es seat. g ,es vs.c. soon(p). )
- Person" means (1) any individ. Other than a written interpretauon by i Osastar. Psovaarows uni, corporsuon, partnership, Srm, as- the General Counsel wel be_ reaarnemart 4
$30.1i Pewpeseandsempe. soci to be himling upon the emn=h
~
t.uo . Oo.or.-- a. enc, . ..d .ni. as.
. M E%y'M : ins.ation, trust, estate, public or private"r'=' "' '
litical entity within a state, any foreign conce
-' amended (S Stat. Sla)* and exemptions 8 '8r8"88% r 888888 8F his part and Parta 3 fra n h a Mann=1 reguirements .
a d1%n M any mr.h e'88F 883U881. 31-as and theappnandana regulauces Sled under in t them ?
'* amittedbyaseMon8 of the Act applic e tw should he addressed to the hter of
-h au persens in me United h nation, or other entity; and (3) any legal Regulation, UA. Atemnis Energy Com- 3 L saan=="ar, representative, asent, er agen- amission,Washlagten. D.C.,306G. ,Onm- -
[$ 38.2 f *===R==8- of ===m - e . cy of the fesegoing; 1 ~ maunsamaanna, reports and appneatlana a
Ibe requiremente of this part are in (D "Physteias" means'am individual anay he delivered in peraen at the Com .l addition to, and not in substitution for, licensed by s6 Biate er territory et the - anassien's ama== at 1717 E Street MW., 1 other W*= et this chapter. In United States, the Distreet of Cohambia Washington, D.C.; at 4015 St. Ebne Ave- q
. any eenslet between the requimments in er the Ca==manwealth of Puerto Bloo to aue, Bethesda,~Md.; or at (c.rnantarrt S
" = -
* ~this part and a spectSe regidreament in -dispense drugs in the prestice of smedi Bid. a _
, 9 J ^another part of the regulatleas in this eine; - r+ r Exxurrrows . E etapter,<the apoetes sagdrement gov. (m) "Productiop faculty" means pro-
,P ' g,,, '
' , - d"a": faenity as dann=d in the regula . I gg,g g '
. ns" J ' M
, . :f ~l b Ige rusnma-san may uput th Wi-i 0 8M Aselvdeles requiring license * ~ WoMconteknedin (a) " Radiographer" yht's 80 Wany uneens thhindi-6; ' c'a' tion of any interested person, er upon H ,
; .. MSer pamanns esempt asprovided <vidual who perferans or who, in attend '!ts own initiative, exemapt eartain samman .,
in this sert and Part' ISO of this chapter, anee at the site where the sealed souree or quantitles of Dyproduct ansterial or
#%_ : no person eheR manufacture, produce, or sources are hetna used, por=anan, kinds of uses or users from the seendre- ,
transfer, seestue, acquise,'oen, pammam* supervises radiographic operations and ments for a license set forth in asetton 81
< use, lumperter esport hyproduct material who is responsible to the unen=ae for as- M the Act and in me aguladoes in this
~ eseept as amahartmed in a speciSc or gen- part and Parts 31-38 whsst it anskes a -
r .i i eral Manna = tsumed personat to the regu- auring mni lanas with 2e neutranents Sading that the exemption of such 'i i*
- of the cammisslan's regulations and me
+ 1 anon.s in eis ahnpe=e, ,
conditions of the license; classes or quantitles of such materist or y ,
. such kinds of uses or users wEl not ' '
; 3 Se,41Desahlema, , _y
~
s '(o) " Radiographer's assistant" maan" consutute an unreasonable risk to me
'. _ .JAs used at this part and Parts 31-36 any individual who, under the personal aa==an defense and enourity and to the ist als chapter: supervision of a radiographer,uses radio- -health and safety of the public.
= , @Md4MW44 C , kJ n.,,
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. . .J.: ^-~ ~] 1 1
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- MZEnAL^ntoisint ? " jjyj $ '
I 30.12 Penons moins bryroduct amate- that such person receives, ponesses, uses, tribudon of lock illuminators whether or ?
'lal under certain Atomic Energy transfers, owns or acquires products or not installed in automobDe locks,is not S
,. . Commae non contracts. materials containtne byproduct material included in this exemption, but may be *
. Any prime contractor of the Commis. in concentrations not in excess of those authorized by a specific license under the provisions of Part 32 of this chapter. 2 sion is exempt from the requirements for listed in i 30.70.
a license set forth in sections 81 and 82 (b) This section shall not be deemed 8M Balances a pwel. ion. of the Act and from the regulations in to authorize the import of byproduct ma- (a) Except for persons who apply trit. this part to the extent that such con. terial or products containing byproduct lum to balances of precision or the parts - tractor, under his prime contract with material. (c) Amanufacturer. processor orpro. thereof and persons who impdrt for sale i l the C^m mlastnn, manufactures, pro. ducer of a product or material in an or distribution balances of precision or
< duces, transfers, receives, acquires, owns,
- possesses, uses, imports, or exports by. agreement State is exempt from the re. the parts thereof containing tritium, any *
- I product material for: (a) 'Ihe perform. quirements for a license set forth in sec. person is exempt from the requirements ance of work for the Comminion at a tion 81 of the Aot and from the regula. for a license set forth in section 81 of the -
tions in this part and Parts 31,32,33,34 Act and from the regulations in Parts 20 United States Government-owned or controlled site, including the transpor. and 36, to the extent that he transfers and 30-36 of this chapter to the extent ' tation of byproduct material to or from byproduct material contained in a prod. that he receives, possesses, uses, trans. such site and the performance of con. uct or materialin concentrations not in fers, exports,' owns or acquires such tract services during temporary inter. excess of.those specified in i 30.70 and balances or balance parts, provided that Introduced into the product or material each balance part contains not more ruptions of such transportation; (b) re. search in, or development, manufacture, by a licensee holding a specific license than 0.5 minicurie of tritium and each ' ' storage, tesung or transportation of, issued by an agreement State or the Com. balance contains not more than 1.0 milli. atomic weapons or components thereof; "8"" ion expressly authorising suchintro. curieof tritium. (b) Any person who desires to apply or (c) the use or operadon of nuclear duction. This exemption does not apply reactors or other nuclear devices in a to the transfer of byproduct material tritium to balances of precisian or the United States Government owned ve. contained in any food, beverage, cos. parts desires thereof for for to import sale oror sale distribution distributionor _ hicle or vessel. In addition to the fore . metic, drug,or other commodity or prod. balances of precision or the parts thereof going exemptions, any prime contractor uct designed for ingestion or inhalation containing tritium, should apply for a 2 or subcontractor of the Commission is by, or application to, a human being. exempt from the requirements for a n. (d) No person may introduce bypmd. specific license, pursuant to 132.18 of this , cense set forth in sections 81 and 82 of uct material into a product or material chapter, which license states that the 1 the Act and imm the regulations in this knowing or having reason to believe that wances of precision or the parts thereof g part to the extent that such prime con- it will be transferred to persons exempt may be distributed by the Heensee to j tractor or subcontractor manufactures, under this section or equivalent regu. persons exempt from the regulations pur- t produces, transfers, receives, acquires, lations of an agreement State, except in suant to paragraph (a) of this section.1* owns, namamam uses, imports or exports accordance with a license jesued pur- h ans
- byproduct material under his prime con. suant to I 32.11 of this chapter or the I tract or subcontract when the Commin. general Ucense provided in i 150.20 of 8 30.31 Types of licen cs.
sion determines that the exemption of Part 150. Licenses for byproduct material are of two types: General and specific. Specific i the prime contractor or subcontractor is 6 30.15 Certain luminous timepieces, licenses are issued to named persons 3
- authorised by law; and that, under the (a) Except for persons who apply trit- upon applications filed pursuant to the j terms of the contract or subcontract.
there is adequate assurance that the lum to luminous timepieces or hands or regulations in this part and Parts 32-36. c warit. thereunder can be accomphahed dials and persons who import foror sale or Generallicenses are efective withou without umdr= risk to the public health distribution luminous timepieces hands or dials containing tritium,-any filing of applications with the Cosnmis Y and safety. 'Any person exempt from sion or the issuance of licensing docu 1 lleeneing under this part prior to the person is exempt frem the requirements ments to particular persons. for a lleense set forth in section 81 of the 6 30,31 Appheations for 'speciSc li-hf elfeettve date of this amandment who would otherwise be required by virtue of . Act and from the regulations in Parts *""*"" 3 this =mnss== to obtain a lleense shall . 30 tent andthat30-36 such of this person chapter to receives, the es-posessass - (a) Applications for specific licensesa continue to be so exempt on an interim basis. Such interim exemption shall ex. uses, transfers, exports; owns or acquires should be filed on Porm AEC-313, "Ap-? Dire Ge~ days from the eifective date of luminous timepieces or hands or dials plication for Byproduct 3Esteria! L1-4 sense", with the Director, Division of V this ammandmant unless within said 40 containing -(b)'Any person tritium.who desires to apply Materials Iale6nsing UE. Atomic En- f
' day period either an application for a tritium to hetnaus tamar ma= a or honda ergy Cament==lau. Washington, D.C <-
namn== covering the activity or an appli. or dials for sale or distribution, et de ' 30645. Appilentions may be fDed in per Y ' i cation' for an ' appropriate exemption ,4res to insport for sale or distribution son at the Camml==ian's amaan at ~1717 4 under tids section is filed with the Coss-messaa, nn. etther such appMantian is luminous nameplaaan or hands or dials H Street NW Washington.D.C.: st 4915 h filed within such 60-day period, the containing tritiusa, should apply for a St. Ehno Avenue, Bethesda, Md.; or at ] interim a===petan shall remain in efeet rpectSc license, pursuant to I33.14 of Germantawn, Md. Information con-6 until final estion in the matter is tahan 'this chapter, whir.h liesnee states that tained in previous appnestaans -state ,t
* - the honinous timap8aa== or hands or dlais menta or reports filed with the Cosenis-4
~I t the fiamme.nean may he'estributed by,the maanaam to s8on may be incorporated by reference,$ l '
- $ 30.13 Camere. < persons exempt from the regulattens provided that such references are clears j
. , J pursuant . to paragrapha'(a) aof this and spectSc., (b) The flammismann may at any tim r3n.numan and contract carriers and he masetan gg,g,, y,,g v; = g aner e Hu M 2e wisinal applica-)
esempt frem te regulations in this part $ 30.16 ^Imek : m. a a .,mu.'d he tion, and befwe me expiration of the H- H
==a==- M - laske.
' and Parts 31-38 and the requireusents "
cense, require further statements in or- 7 for a lissess set forth in section 81 of the Any person is exempt from the re- der to enable the Cammismaan to deter I' ' Act to he entent that Mey transpwt by. quirements for a license set forth in mine whether the application should be parent NOTEtv.t9)or 2: purp.ikes mto ammnt the daughters. oses af 13014 where there is involved Manganese (25).. Mn52 3xle a cornt mat 6on of tsotopm, the hmit for the combinatkm Subject matter Of this part. M n 54 lxle s shoubt l.e denveif as fohn s-M n 56 1xtts t> 5 31.2 Terni, and conditiona. Mmury tw ne twm 2xle i.et.etermme for cch Lutore in theinproduct the ratta een the concenirsunn preent the roduct and (g) The general licenses provided in biolybdenum t 42).. M o v9 M NN 'rNe'"l't7t'oNfe$" * ' nit $Nid"atfn'.Ne^=us 2xit8 ci such r-uW may not esceed "l'* (1.e., unity). this part are subject to the provisions of Il 30.14 (d) . 30.34 (a) to (e), 30.51 to Neodymium 60)..
. j g7 g Eumpie-lxm s Concentrauan ot tetape A ln i roduct F 30.63 and Parts 20 and 36 of this chap.
Nicket (m . .. . . . N r>5
. Niobium iCoius.o .N b s5 lxio
- E wn+t concenuatwn of isoiope ^
ter ' unless indicated otherwise in the blum) (41) Nb94 9x la language of the general license. Osmtum (76)'^ ' OsIM 7xin* Concemtration of I.sotope il in Product Os imm 3x to s ostM 2Xte
~ E serkpt cEncentration or lEtot+ 15 SI
- Attention is directed particularly to the Os ISS 6x10
- provtstons of the regulations in Part 20 of
' V.stues are it: yen only for those materials normally -Pallwilum t w '
rd itu 3xlu 8 u et e e#.- this chapter which relate to the labeling of 3 l'd low i w K io * ; ut m ("r el . c ntainers.
, No.123-2 i ?
r
~ * &
Q: 8190 RULES AND REGULATIONS $ 17 g
<b) Persons who transfer, receive, ac- uct material listed in i 31.100 Schedule fer, a report contaimag the name of the4 quire, own, pouss, use or import items A, provided that no person shall at any manufacturer of the device. the type of g 7" and quantities of byproduct material one time possess or use, pursuant to the device, the manufacturer's serial num- l' 3 pursuant to the reneral Heenses provided general licensing provisions of this sec- ber of the device, and the name and ad M tion, more than a total of ten such sched- dress of the person receiving the device; 7 in il 31.3 and 31 A: (2) Shall assure that all labels afHxed T' (1) Shall not c!Tect an increase in the uled quantities. to the device at the time of receipt and /.
radioactivity of said items or quantities g 3 3, , gg;n ,. ; ; bearing the statement. "Itemoval of this , by adding other radioactive material yongm;y ,g,,;yn, label is prohibited by regulations of the s thereto, by combining byproduct mate- tai Subject to the provisions of this M rial from two or more such items or quan. section, a general license is hereby issued tained Atomicthereon Energyand Commission", shall complyare withmain all E[L titles, or by alterin.; them in any other to own, receive, acquire, possess and use instructions contained in such labels- . , manner so as to increase th ??by the byproduct material when contained in 43) Shall have the device tested for .M: I . rate of radiation therefrom; devices designed and manufactured for leakage of radioactive ma oerial and '$* (2) Shall not administer externally or the purpose of detecting, measuring. proper operation of the on-off mecha- 4 u ;. internally, or direct the administration gauging or controlhng thickness, density. nism and indicator. if any, at the time tu of, said items or quantities or any part level, interf ace location, radiation, leak-of installation thereof to a human being for any pur- age, or quahtative or quantitative chem- ment of the byproduct material on the of the device or replac u m pose, including, but not limited to, diag- ical composition, or for producing light premises of the general heensee and4h t-nostic, therapeutic, and research pur- r an ionized atmosphere, poses. (b) The general license contained in thereafter at no longer than six-monthfi W[ '+ (3) Shall not add, or direct the addi- this section applies only to devices which to exceed intervals three oryearsat as suchare specified longer in intervals n tion of, said items or quantitles or any have been; the label required by 131.5(c); provided part thereof to any food, beverage, cos- (1) Manufactured in accordance with need that devices containing only krypton not bc tested for leakage, and de y" " 'd metic, drug, or other product designed the specifications contained in a specific for ingestion or inhalation by, or appit- license issued by the Commission to the vices containing only tritium need not bh *I cition to, a human being; manufacturer of the device pursuant to tested for any purpose; q . tu (4) Shall not include said items or 5 32,51 of this chapter, or in accordance (4) Shall have the tests required by ^ / quantitles or any part thereof in any with the specifications contained in a subparagraph (3) of this paragraph and N. g device, instrument, apparatus (including specific license issued to the manufac- all other services involving the radioac .3 component parts and accessories there- turer by an agreement State; and tive material, its shielding and contain.' J to) intended for use in diagnosis, treat- (2) Installed on the premises of tr' ment, performed by the supplier or ,' a ment or prevention of disease in human general licensee by a person authorizt other person holding a specific license! ( beings or animals or otherwise intended to install such devices under a specific from the Commission or an agreementt , to affect the structure or any function license issued to the installer by the State to manufacture, install or serviceC of the body of human beings or animals. Commission pursuant to Parts 30 and 33 such devices;
$ 31.3 Certain devicca and equipment. or by an agreement State, provided that (5) Shall, within 30 days af ter the oc@W the specific license referred to in sub- currence of a f ailure of or damage to the' E A general license is hereby issued to paragraph (1) of this paragraph con- shielding of the radioactive material or D ,
transfer, receive, acquire, own, possess tains provisions authorizing the transfer the on-off mechanism or indicat(x or' F p and use byprcKluct material incorporated of such devices to. and the installation upon the detection of 0.005 microcurie l S in the following devices or equiprnent of such devices in the premises of, gen- or more of removable radioactive mateN 1 which have been manufactured, tested eral Heensees, rial, furnish to the Director of the apO , and labeled by the manufacturer in ac. (c) The general license contained in propriate Atomic Energy Comm*n y cordance with the specifications con. this section applies only to devices Regional Compliance Office listed in tained in a specific license issued to him which (1) are labeled in accordance with pendix "D" of Part 20 ef this cha L by the Commission. the provisions of the specif c license " Standards for Protection Against Ea'- e r (a) Static chminatiors device, Devices which authorizes the distribution of the diation", a report containing the name of " t designed for use as static climinators device to general licensees, and (2) bear the manuf acturer of the device, the type 1: e-which contain, as a sealed source or a label containing the following or a of device, the manufacturer's serial ntmr-sources, byproduct material consisting of substantially similar statement which ber of the device and a brief description n total of not more than 500 microcuries contains the information called for in the of the event and the remedial action of polonium 210 per device. following statement: taken; and shall maintain records of all i (b) Spark gap and electronic tubes. This device, generally Itcensed pursuant to tests performed on the devices as re-a Spark gap tubes and electronic tubes I 32.5 of Io CFR, Part 31 ' has been inanu- quired under this section, including the .. e which contain byproduct material con. tactured and distributed pursuant to license dates and results of the tests and the r sisting of not more than 5 microcuries DI --~~-- 7 (Insert either names of the persons conducting th6/*b ,: per tube of cerium 137, or nickel 63, or .DAto rn~te Energy Conuntaton. or~ ***"'d naIne of tests
- N '
krypton 85 gas, or not more than one agreetnent State, whichever is appitcable). (6) Upon the occurrence of a failure W microcurie per tube of cobalt 60. _______________._______, of or damage to, or any indication of &%(,(, (c) Light meter, Devices designed for (Name of supplier) possible failure of or damage to, th87[ use in measuring or determining light (d) Persons who own, receive, acquire. shielding or containment of the ra j intensity which contain, as a sealed peess r use a device pursuant to the active material or the on-off mechanwn , source or sources, byproduct material generallicense containea in this section. or indicator, shall immediately suspend q r consisting of a total of not more than <1) Shall not transfer, abandon or operation of the device until it has been, a 200 microcuries of strontium 90 per dispose of the device except by transfer repaired by the supplier or other perq g to a person authorized by a specific h- son holding a specific license from the, n device'lon (d) generating tube Devices de- cense fr m the Commission or an agree- Commission or an agreement State 40pDu signed for tonization of air which con- ment State to receive such dnice and manufacture, install or service such , 3 tain, as a sealed source or sources, by- shall furnish to the Director of the ap- Vices, or disposed of by transfer to a pet 4 1 product material consisting of a total of propriate Atomic Energy Commission son authorized to receive the byprod 7 not more than 500 microcuries of po- Itegional Compliance Office listed in Ap- material contained in the device; 2 lonium 210 per device or of a total of not pendix "D* of Part 20 of this chapter, (7) Shall be exempt from the requireg, ] more than 50 millicuries of hydrogen 3 " Standards for Protection Against Ra- ments of Part 20 of this chapter, excelg , (tritium) per device' diation", within 30 days af ter any trans- that such persons shall comply with theN-
$31.1 Certain quanthics of hyprmhirt provisions of Il 20302 and 20A03 of this ^:
- Devices acquired not rnore than 8 rnonths gpg* f rusterial. af ter the effective date of this recodification, (e) Persons w ho possess byprod 3 A general license is hereby issued to may bear labels referring Instead to material pursuant to this generallicenseg, transfer. receive, acquire, own, possess, "g so.21(c) of to CF14, Part 30/' untti the shall not export such byproduct mater 41 .,
use and import the quantities of byprod- label ta repbced. , D,
; o 7y a W
j 3
p-p;:q .. y Q:v. w wyn sw ;. :
., 3 4 ym.g gag;qw 3m.y gg y,,, g, gg . < . . . NDERAL REGISNR ^
. ' 8151 " 4 l without a apae[se license from the Com _ tion,T=== tan or use of promethium 147 structed to contain americium 341 which contained in instrmnant dials.
mission authortsing such export. might otherwise escape durtw storage. I 31,6 t'-==-st license se lastall devlees 8 31.s Anmerielum 241 in abs forma of (5) Shah ret w mach sou*ce for any
. esmerally He====d in $ 31.5. calibration er reference samme, radia nd or e diza Any person who holds a specific license (a)' A general license is hereby issued tion of other sources.
lasued by an agreement State authoriz- to those persons listed below to own, re- (d) This general license does not ing the holder to manufacture, instan ceive, acquire, panaman, use and transfer, authorize the manufacture or import of or service a device described in i 31.5 in accordance with the provisions of calibration or reference sources contain-
! within such agreement State is hereby paragraphs (b) and (c) of this section. Ing americium 241.
I granted a general license to install and americium 241 in the form of calibration (e) This general license does not l' service such device in any non-agree- or reference sources: authorise the export of calibration or i.
*~
ment State; Provided.That: (1) Any person in a non-agreement reference sources containing americium (a) Buch person shall file a report State who holds a specific license issued 241. with the Director, Division of Materials by the Commission which authorises him I4 censing, UE. Atomic Energy Cammtz- to receive, possess, use and transfer by- l 31.9 Cencral bcense to own byproduct i sion Washington, D.C.,20545, within 30 product material, source material, or spe- "*'"I*I-days after the end of each calendar quar- cial nuclear material; and A general license is hereby issued to ter in which any device is transferred (2) Any Government agency, as de- own byproduct material without regard or installed. Each such report shall fined in i 30.4(g) of this chapter, which to quantity. Notwithstanding any other identify each general licensee under holds a specific license issued by the provision of this chapter, a general 11-I 31.5 by name and address, the type of Commission which authorises it to re- censee under this paragraph is not au-device transferred, and the quantity and ceive, possess, use and transfer byproduct thorized to manuf acture, produce, trans-f type of byproduct material contained in material, source material, or special fer, receive, possess, use, import or export the device. nuclear material. . byproduct material, except as authorized (b) The devloe has been manufac- (if) The general license in paragraph in a specific license. , tured, labeled, installed, and serviced in (a) of this section applies only to calibra. accordance with applicable provisions tion or reference sources which have Benzws.xs of the specific license issued to such per- been manufactured in accordance with 8 31.100 Schedule A--Generally li-g son by the agreement State. the specifications contained in a specific eensed quantities. 1
, (c) Buch person assures that any license issued by the Cnmmiazion to the The following quantities of byproduct ,
i labels required to be afBxed to the device manufacturer or importer of the sources material are generally licensed pursuant
! under regulations of the agreement State pursuant to I 32.57 of this chapter or.in to i 31.4. i which licensed manufacture of the de- accordance with the agiecifications con- 4 vice bear a statament that Esmnval of tained in a specific 11oense issued to the this label is prohibited by the regula- manufacturer by an agr**mant State tions of the Atomic Energy Comm1== ton." which authorises manufacture of ~ the
, W D" J
*r smal esinawial l eac(d)
Such person shall furnish to sources for distribution to persons gen-h general 11nename to whom he trans- erally licensed by the agreement State. N [d re. sea,. 8 fers such device or on whose premisma (c) The general license in paragraph (mkre. (maro. i he installs such device a copy of the (a) of this section is subject to the pro- "" '""") 8 general license containad in i 31.5. Visions of Il 30.14(d), 30.34 (a) to (e). j 0 S1.7 .-a **I*'T de,sce. go, e and 30.51 to 30.63 of this chapter, and f,EW g%'e* .Jas $ 3 to the provisions of Part 20 of this chap- AmuseW(as m a T I" "I'"I ter. In addition, persons who own, re- s--aw- - am m .
' ta) A general Manna
- is hereby issued esive, acquire naan== use and transfer agay~iiif7) .. . ..._
, ,c
.a &
to own, recette, acquire, pa=m- and use one or more calibration or reference "p""8#-88=88(CdA8 so 13 tritham or promethium 147 eentainad in sources pursuant to this general license. cDisidies) E E __ imnim= safety devlees for use in air- (1) Shall not pamaans at any one time, carmaa na (c14) _ _ a a 4 ; eraft, provided each deflee containa not at any one loostion of storage or use, * - - - " " " '
- more than four curies of tritium or 100 more than 5 microcuries of americium D .'[Esifidiliisis"")~ no baart no 1 l mitu,wges of prnmehtum 147 and that 3411n such eources!
' ameh devlos has been mannfam*med, as*
(3) Shan not receive,' possess, use or ostelte(osk-M 7 8's) E' E I 4
$li a no sembled or hnported in accordance with transfer such source unless the source. 88 #
a Hannan instand under the provisions of er the storage container, hears a Inhel O*88" Dia*8 Q#-"'" E 'E #'
$ 33.53 ef this chapter er manufactured whleh includes the foBowing stateenent omne rs ton - m .as or am-nhand in assordance with a spe- or a substantially shnnar a4mimaamme
- etfic Mmnas jggued by an aggummant ggste wllich contains the informannan eensa as N
l. a
,ll
~,as
$l
,y k
which autherless mannrameure or as- for in the foBowing sts#mmant- - sembly of the devlee for distribution to , f . seen M::i. us)
' . . . .* *)
no
'E
- no 1 permuis genermEy M===d by tine agree- this source, asod '
ment State. 5 '
.. seriet N are subject to a general noense sad the res- Den 8 D "E".- mL
'E'1 to ?
' (b) Persons who own, receive, acquire, unations or the Unites senses Atomic anergy lanthemen 14 4 38 10 j possess' or use h=mim- ~ safety devlees na==i==taa or or a seate with whlek the pursuant to the general Man == la this na==i== nan has entered into an asseammat $ $
(ns. sis d
' as no i
y; Sectica are ex6 frten the require- for the exercise of regulatory authority Do manan of Part se of this chapter, asespg mot ream this labe gn WL 1 30 a that they ahan oc,anply with the pro- catrrsoN amADIOACITVE aEA1EnIAL - Peeneumam (Pdsem _ ....._ m Nteheum n (Wh es) E se [' visions of 36 se.4es and 30.403 of this tuna novacs coarranes AnsEnscrUna PR*,'," '"-"***"" '"~~~ N . . s shapter. . 341. DO NOT 'IUUCIE RADIOACITVE PhsusherisliiYaft ID to
- POnTION OF TEUs SOUNDE. rehmtum *' f
. > (e) This serieral neen= does not au- 4!9 - d d Y thoria the su n facture, amanhiy, i.- -
(Name or ananufacturer orimporter) Pem.m.e.m.e e . yw i (p.er
.( . m m q
~
' pair or insport t t Im=*namaa safety devices ag) g j eentaining trtttaa or prnmaahtum 147. ' (3) Shall not transfer, ahamian, or ansdam ses kan sesi.. no no ;
-(d) 'this general unana* does not au- dispose of such source except by transfer g #(g, bas, no to e tortee the esport of humainnus enfety de= to a peroDR authorised by a 110Bnse froEn
, _ .g.
-(amah asBL...._ _ _ 1 le vases ocatatning trtthest or promethtuen the iannminalan r or en agreemaant State ihmertum is me is) to ' so 6
- 147 esespt km asserdense with the provi- to receive the source.
dans of Past 38 ef this shapter. t - (4) Shall store such sourse, except sever ni M " ( *) nu is
- E.
no J e s - (e) ' Ibis general Maanan does not au- when the source is being used. In a elooed 5 - - - - - - g -g I O thortse the ourneschip, zesett, request- mantainer adequately designed and oon- Mmumm so m. ,,, - (er so) .m E e b.: n ~ _ ,N_ Mr 34 ~ _{
, ,7 , ,
d
.. . . ,_, . . . . .. _ . . . s.. . , , . .. -
_ _ . _ _ r,. em.- - - ~ .- , ,. . , . m. m ;be,s . m y.,,,y,,_h : .m- m . RMB- - RULES: AND- REGULATIONS -
, y, ,
._ .:l /.i '
Bac- - , transfer of the product or material, and catama Cohmia 323e name: labeHng et devlees. estimated Concentration of the radio-N o.1 met u 32.50 same: soma tesung at eesh source. R8o Sama:Insterial transfer reputa. Isotopes in the product or material at the Bypredest matartal Asa time M transfer
- and is N.o.twssa aunsd 32.70 Manufacture and distribution of by.
soume sonne product materials for medical use (c) Provides ranannahle assurance ,#. uma onie under general noenu. that the concentrations of byproduct -
"'"") '""'*) 32.101 Schedule B-Prototype tests for material at the time of transfer wiU not '
lutninous safety dances tw use in exceed the concentrations in i 30.70, itronuum c:>-Yttrtum 90 (srY).. e. I 1 aircraft. that reconcentration of the byproduct Mmgr(ao
$ $ 32.102-Schedule C-Prototype tests for cat. Material in concentrations eZeceding Dinwoum os e 14. .... .. I to idration or rermee mzrces con- those in 130.70 is not !!kely, that use of .
*** *I"8 **"""I' IT[
durtam ta eim. i$ 5 i E io Abport C-ovelay control semplias lower concentrations is not feasible and that the product or material is not, likely i MQ,% n* E $ Precedures tobe incorporated in any food, beverage. ' rungsten ins (w inst to 10 ya. a =matic, drug or other commrdity or gnag g~' } @ 32.11o Quanty controlspecinc under certain == pun noenees. product degned for ingestion or inhala-httriumagsu i 10 AvrnoarrY: The provisions of this Part 32 tion by, Or applicat!On to, a human being. , lasued under sec.161. Os Stat. 94s; 42 U.S.C. % 83 an % dnmae sto product ===rarwnot Based I le 2201. Interpret or apply acca. 81.182. las, $ 32.12 Sammet Maaerial transfer Wa. es stat. ess, esa, est: 42 Us.C. 2111. 2232 Eac!1 person licensed tmder i 32.11 2233. shaft f!1e a report in duplicate with the C""" #" *** Director, Division of Materials Licensing, New section 02d seefWt 9 32.1 Parpose and scope. United States Atomic Energy Commh-11.1- _ - Nr (a) This part prescribes requirements sion, Washington, D.C., 20545, describ-31.2... . - ..- .... so21(b) for the issuance of specifie licenses to ing the type and quantity of each )1.3 - s021( 1). persons who manufacture, distribute or product or material into which byprod-s{a 3021(c) (1)-(s) imp 3rt items ermtafnmg Lsuduct ma- uct material has been introduced during . 31.s _-, ........ ..... 30 21 ( c ) ( 6 ) terial for distribution to. (1) persons the hyvai.111a period, name and address 3,7 - so21(c) mmpted front the Beensing require- of the person who owns or possesses the )12- . so.21(e nmtm of Part 30 of this chapter, or (2) product or material into which by-31.9 - so.21(f) persons generaHy !! censed tmder Parts product material has been introduced, 31.100 30.72 31 or 35 af this chapter, ' Hits part' the type and quantity'of Lwivd4 ma-also prescribes certain regulations gov- terialintroduced into each such product 2AtT 32-SPECIFIC LICENSES TO erning holdendsuettucasses tion, this part prescribes requirements In addt- m materia!, tions of byproduct and the intual in material coricentra-the prod- l MANUFACTURE, DISTRIBUTE, OR for the issaanee of specific Beenses to net or material at time of transfer af the l IMPORT EXEMPTED AND GENER- persons wbp httroduce byproduct ma- byproduct material by the licensee. ' uisa ALLY UCENSED ITEMS CONTAIN- terial into a product or material owned 'Ite report shan be submitted within 30 by or in the ====ahm of the licensee or days after the end of each calendar year W ING BYPEODUCT MATERIAL another and regulations a vua, Jus hold- in which the licensee introduces byprod-D- y ers of suchBeenses uct material into a product or material > $ Purpose and scope. (b) *nte provisions and requirements pursuant to a license granted under subpart A-.-amemps cancentren se and lasses of this part are in addition to, and not in I 32.11. ,, D.11 Introduction or byproduce mterlat subsutution im other useaums M g 32.13 Same: Prohibhien of introslac. in emesept -="a== taso this chapter. In particular, the provi- g;,,, , produets or materials, and trans- sions of Part 30 of this chapter apply to , , rar or owneraatp er r "-: applications and licenses subject to this No person may u.suvw byproduct requir m nts for 1kanse. part.. material' into a product or material 12 n===: Material transeur reports. knowing or having reason to believe that
< 13 n*ma: Prohibition ef introductkm. . Subper! A-Exempt Conceadroh. ens it will be transferred to persons exempt - a certain inmenous amepisces: re- anel items under I 30.14 of this chapter or equiva-anport B 32.11 Introduction of byproduct ma- M ntnmns W an agnement M.
I).1s certain automoboe locat m-dma- serial la rzempt courmtrations lato exceM in accordance witti a 11eense is-ters: requirements for uornse to - proderts er masterials, and transfer sued pursuant to I33.11 or the general anstan or import. of _ - er - _: rp Boense provided in f 150.30 of Part 150. e ma-a: quauty eestral. , aments for M ' 7 amane: zameertet tramane imports. - 52.14 ,Ca'sealm M aes * - : i in nana== at praatanan: resguisemente -An apenastaan for a spes&Gs Beense for 3*"*"aa l' apply er ser laosase to apper or *mr= t authoristas the introdustles of br - s Impest admism. trttausa. - ' product mana.aal into a product or san- EAn appineatica for a aparifle license to na masterial tanarer seports. - terial owned by or in the pommanslan of apply tettlana cor**tnad in bmine===
. 40 D -"y===m:une jests for the licensee or another and the transfer compounds to timepiecen er handa or m
of ownership or pa==aastan of the product dials, or to import timepieces or hands Sebpset 5 - - C, useased hoses or saaterial aan*aint=f the byproduct er diens maritatninr trittuna for use pur-pas certatn ansa uring, osasing er son- smatertet .will ,be approved if the ~ smant to $ 30.15 at thAs chapter will be trouing e.,tese senerauy neensed applicant: appuwed $ft i under i sta at this chapter re- (a) Satisfies the general requirements (a) The applicant patannaa the general , ! . sguirements for nee ase to distrib- specified in I 30.33 of this chapter; requirements specified in I 30.33 et this ' ***- (b) Provides a description of the chapter: ., "I g "" = (b) 'Ibe applicant smhratta snEBalant
- ety dersees use in product or material into which the by-strernet requiremnants for uosase product mats =1a1 w!!1 be intrutuced, in- information relating to the chssniemi to =anneneture,. samemble, repair tended use of the byproduct material and and physleal composition and character-the product or material into which it is istles of the Itmainaus compour'd(s), the
. or import.
sem:1 benngorantees. introduced method of introduouan, unethod et appnaamn of each com-ma-: quanty omaron: prohiutana or initial concentration of the byproduct pound, quaBty control proceenres and
, , . ,,h'*"M' dat transta reports, material in the product or anaterial, een prototype testing of tannt=== dlais; and- '
- 7 racon er rotesvam seurens non- trol methods to assure that no more than - (e) 'Ibe tritican is bound in the lumi-on.ub.nin, the speelfled consentratton is hatroduced nious -.~.uid in a non-water-soluble )<
. Amerwn= set: segua, miente for noense to man =ressure into the product or amaterial, estisested and non lahHn forma and the aa===md .
erimport ,. ' time interval between introduction and is . bound- to *- the dials or handa- '11ae p ,_ , , = [ ,
.a < ~ . .: a .. .
4 A f,; . 6 s - + 1 s . . . _ _
s -
~
p
- Sabrday, June 28, 1965 7EDERAC REGISTQ Mc 8193 i
~
tritium win be consid: red to be properly determination of the nfety of the lock the parts thereof, or to import balances o bound to the dials and haneta if there is 1Huminator. -. of precision or the parts thereof contain- ' no visible flaking or chipping and the (c) Each lock inumtnator win con- ing tritium, for use pursuant to i 30.17 total loss of tritium does not exceed 5 tain no more than 15 minicuries of trit- of this chapter will be approved if: percent of the total tritium when proto- lum or 2 millicuries of promethium 147. (a) The applicant satisfies the gen-type dials and hands are subjected to The levels of radiation from each lock eral requirements specined in i 30.33 of . .
. the foHowing testa in the order specified illuminator containing promethium 147 this chapter; and below: will not exceed 1 minirad per hour at (b) The applicant submits sufncient (1) Attachment of dials to a vibrating 1 centimeter from any surface when information regarding the balance parts
} fixture and vibration at a rate of not measured through 50 minigrams per pertinent to evaluation of the potential less than 26 cyc!es per second and a square centimeter of absorber. radiation exposure, including: ..
vibration acceleration of not less than (d) The Cnmmiutnn determines that: (1) Chemical and physical form and ..~-- 2 O for a period of not less than one (1) The tritium or promethium 147 maximum quantity of tritium in each - j hour; and is bound in the luminous compound in a balance part; (2) Attachment of the hub ends of nonwater soluble and nonlabile form, and (2) Details of construction and design the hands to a clamp and bending of the compound is incorporated and bound of the balance part; V
. hands over a one-inch diameter cylin- in the lock illuminator in such a manner (3) Details of the method of incorpo-der; and that the tritium or promethium 147 will ration and binding of the tritium in the
, (3) Total immersion of the dials and not be released under the most severe balance part hands used in the testa described in sub- conditions which are liket to be en- (4) Procedures for and results of pro-paragraphs (1) and (2) of this pars- countered in normal use and handling; totype testing of balance parts to demon-graph in 100 mill 111ters of water at room (2) The tritium or prometraum 147 is strate that the tritium contained in each temperature for a pedod of 24 consecu- incorporated in the lock illuminator so part will not be released or be removed tive hours and analysis of the test water as to preclude direct physical contact by from the part under normal conditions for its radioactive material content by any person with the tritium or prome- of use of the balance; liquid scintillation counting or other thium 147. (5) Details of quality control pro-equaHy sensitive method. (3) ne method of installing the lock cedures to be followed in the fabrication (d) Not more than a total of 25 mint- illuminator into the automobile lock is of balance parts containing tritium; and curies of tritium wiH be applied per such that the lock illuminator will not (6) Any additional information, in-timepiece; and become detached from the lock under the cluding expedmental studies and tests.
(e) Not more than a total of 5 mini- most severe conditions which are likelY required by the Commission to facilitate curies of tritium win be applied per hand to be encountered in normal use and determination of the safety of the bal-and not more than 15 m1111 curies win be handling; ance part. ~ appned per dial (bezels when used shan (4) The device consisting of the auto- (c) Each balance part will contain no be considered am part of the dial). mobile lock with the installed lock tuu- more than 0.5 minicurie of tritium and '
"'"*t" hS8 been 8ubjected t hp each balance will contain no more than 15 Certain aniomobile lock it. t type tests and meets h nquirements 1.0 millieurie of tritium.
s 32'luminators:. requirements for li- prescribed by I 32.40, Schedule A. cense to install or import. (d) The Commluton determines that: ' An application for a specific license to $ 32.16 Same: quality cositrol. (1) ne method of incorporation and f instan lock inuminators into automobile Each person licensed under i 32.15 binding of the tritium in the balance part is such that the tritium will not be re-locks, or to import for sale or distribu- shall: kased w be removed fun h part under , tion lock illuminators in automobile (a) Leatntain quality control in the locks for use pursuant to 130.16 of this manufacture of lock IHuminators, or the no conditions of use and handling, chapter win be approved it: installation of lock Uluminators into au- (2) The trit:um is incorporated or en-(a) ne applicant satisfies the general tomobile locks; e n p so as to p imiuuients specified in i 30.33 of this (b) Subject production lots to such e chapter- quality control tests as may be required tduum W any person unde ordnary (b) The applicant submits sufficient as a condition of the license issued under cimumstancesof use. , information regarding the lock 1Humina- 1 32.15 sampled in accordance with tors pertinent to evaluation of the po- 132.110; and . ~ $ 32.19' Sames material transfer reports.
,tential radiation exposure, including: (c) Visually inspect each devicein pm- Rach person licensed under i 32.18
- (1) Chemical and physical form and duction lots and reject any device which shah Sie an annual report with the Di-
; marimum quantity of tritium or pro- has an observable physical defect that rectw, Division of Matedals Ucensing" s
{ methium 147 in each lock 1Huminator; could affect containment of the tritium U.S. Atomic Energy Commini c. Wash- .
< (2) Details of construction and design or pmnethium 147. Ington, D.C 20545. which shan state the .
of the bck inmntnate: 5 32.17 Same material transfer reports. total quantity of tritium transferred to
" ~
during in e
, . - 9 sh file annual port
- I *
,' (4) Details of the method of hm= rectw, Diviska of Materials Ucensing, Each a r the lock 1Huminatnrs into the automobne U.S. Atnmin Energy t'nmmtatnn Wash-f lock so that the lock illuminator is not ington, D.C.,20545, which shan state the year emiing g June , 30 and shan be filed readHy removable from the automobile total quantity of tritium or promethhun joeg*. - 147 transferred to other persons under 5 32.40 Schedule A-Protetype tests for (5) Froc61uses - for and results of I 30.16 of this chapter, during the re- autonnobile lock (Emminators. >
prototype testing to demonstrate that porting period, in the form of bck H- An applicant for a license pursuant to ~ 1 i the lock illuminator will not become de. Inminators contained in automobile i 32.15 sha!! conduct the following pro- ' . . tached from the lock and the tritium or bcks. Such report shan identify by totype tests on each of Sve prototype de-promethium 147 will not be released to name and address all persons to whom vices, consisting of the automobile lock the environment under the most severe a total of more than 5 curies of tritium or promethium 147 were distributed unfonowing .with theorder: instaHed innmtnator, in the # conditians likely to be encountered in
- normaluseof thelockilluminator; der I 30.16 of this chapter during the (a) The device shan be subjected to (6) Quality control pruculuum to dem- reporting period. Each report shall M he d WM wee m a onstrate that producuon bts of the lock cover the year ending June 30 and ahall suitable weathering machine which simr illuminators win meet the specifications be Sled w1Wn 30 days thenaften ulates the most severe ammma of nor-established by the Cammia-lon for such 9 32.18 Balances of preens ons require- maluse: .
; lock * =' W ~s; .
mente for license to apply or import (b) The device shan be dropped upon (7) Any additdanal information, in- tritium. a concrete oriron surface in a 3-foot free
.cluding experimental studies and tests,' An application for a specific license to gravitational fan, or shall be subjected to -
required by the rwnmtmainn to faciutate apply tritium to balances of precision or an equivalent treatment in a test device - L- . i ' . . Xx e a
^w% 1 N&*
p;y W & f 7 $qMY. ? &m?, _& $: ? .~N Tf~;V - $ 3 ?,;S W'fQ;, h M h,3,;p.g y ';
- n. ;
wa _.
..y ; o a m, .. <
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h ameh a SaR.* The deep test :- G) . The byssedmet, mmenenal ammana=,d to (b) Furnish to each general Heenose
~
shout he transfers such device a copp shaR he repeated Ice tesmas trous sendous in the devloe wul not be lost;. w (2) Ita persen womh1 resolve a radia- of tbs genere1 Hoense contained in i 31A % ! estameneanne- l; (D '2he destee shan be c e*mahaf to a tasa empeouse to a annJor postaan af his of this chapter. } v9tatory Buture and vibrated as a rate body in emessa of 0 & ress in a, year $32.53 haineum mareer devices fee one , .; y, l ef not less than as eyelen per aseemd and under ordinary cargumstanees of use; I" *I" *I" - --- I*' M'**** * } G) 'Ibe device een be anfely operated namefacom, mem-bl% wpair er i . O vibration acceleration of not less than ' 2 O for a parlod of not less than 1 bour; by persons not having training in radio- fMP0H. (d) On essaplettom of the foregoing logical protection; and _ An application for a speciSc license to tests, the device shall be inw=*rsed in 30 (4) The byproduct material within the ; i inches cf water for 24 hours and shall device would not be accessible to un. manufacture, hmin== safety assemble, devicesrepair containingor import trit- < show no visAde evidenen ef' water entry authorised paranna, I (c) In deserthing the inhal or labels lum or promethium 147 for use in air-teto the logg Rhminatar. Absohnte pres- , I sure of the air above the water shall then and aantanan thereof to be ammed to the craft, for distribution to persons gen- j ] be rednand to 1 inch of meercury. devlee, hadiente the appaienne. abould separately armuy licensed under i 31.7 of this chap-those instruotfons and preceu ter, w1H be apbrVved if: . t LowIred pressure shah be =mintained ' (a) 'Ihe appl!CaDt mattaft*s the Etn= f - Ser 1 minute er until att hahhina esage to $4 ens 1mhhrh are nanammary to mesure amie eral requirements spectfled in i 30.33 of ' J. ' he given eE by the water, wheebevor as operation of the devloe. - Such instruc-the long;.r. Pressure shall them be in. temas and preesuttons ahana he containad this (b)chapter;
'Ite applicant snhmits suffLient ernamed to mermant =k=a=ph==ls taaseure. om labels beart 4 the sta mment . ge-
- Apr eyedmann af behhles amanne8ng frem massal of thle laket puuhthited ly reguia- informatinn regarding each device Jetti-witada the immhr uhsmaama%ar, or water en- tanna of the Atemde Energy r%wamismann " nent to evaluation of the potenttal Mdia-tartnr the look nhandnatar, abaQ he ann- (d) In the event the appusent deskres tion(1) ex.oeure, Chamteal inctndtne:
and physical forIn and steeredleeksee: that the devies be tested for proper oper- martmum quant 3ty of tritium or pro-(e) After each of the testa preemibed aston of the on-of ummehmei== and indi. . br this amelion, each device chan be ex- cator, if,any, and for lankase of ramo- methium147in (2) Deta!!s of ccustructioneach device; and de-numanad ger evidence of phyeleal demance active amaterial, -h=mnp==* to the initial -and Ser less of tr eahama er preensthiuum tests required kr SE1.5(d)(3) of this sign; (3) DetaUs of the method of tduding =147. Aar estemnn, of h mmem to or shapter, at intervals innrer than alz or containtnr the tritium or promethium Smiture et ser dettee w4dets oeuld afect aannehs he met ==mandenqr tierse years, < the-a=t=====* et the triehus erpresse- he sheE tuntude la has assiicatien suB- 147; (4) Procedures for and results of pro-tidusa Ed1 in mesh devices ohnu he eause etsat lufosumattant to dummanskemae 31st ictype testins to dutnonstrate .that the for rejection of the design on widah such longer interval is justified kr per-such poetetspo destees were esestrusted foramance sh===mtarteties of the devloetotritium released the environment or pra==*hhna under the 147 wS1 not be eranasuutassuseett thedesmoseerfailure er stansar dartsen, and by shmalen fan- most severe condittons Ekely to be en- i la ettyen-naan. to design defeeL Emes of teens widset Insee a ma manamma r haastag _ tritiusa or presnethtena 147 fauna eneh as the prehmbater er emessessmens of countesed (5) Anylaguett6r mesumet control use; ,preesdures
- j tested deutse atenR be mesasured boik by leakage of r=dnammesse asetertal frena the samapMas the tuseneralem test water need device. In determining the maaartaht* serthed proposed or 3 32.M; as alternatives to these pre-
! -g la peregresh 44) of this easties and kr intervalfor test of leakage of raittnactive (6) Any additional informatinn, in-anatorial, the r9m===e= dan wM consider "- studies and tests.
utping assessede
? wittk . Alter paper the -entireseen af -the s look 1 Bund- . Inforniationseguired on particulars kr ther k==i-fan which in-to. elading facultate ess, ' ' ?.
mater. BEsmauressants .ef tuttimum or stude, but are not ===m====gy numa*md to: a deteradaation .of the safety of the , promethhun 147 aball be saade in an ep- * (D Primanry'eentatsmaamt - oq ' (asuresemp-
, device. 3 . . ..
pesatus emmseted to assasuse tasadumn or enge); - m 6a) Each devlee isG1.eentain no more pausestidusa 147, a as espuesstate -If . (2) Pratmetian of prisessy seatets- - then four earles of tuttiusa or 100 mHli ' enere ham til.possent of tha original unsat;
'ts) assahad of ammaher mnamhumant . euries of prennethium 147. The levels esmemet.ci tuteluma er numanathimum.M7 of rememos tream each device manaminang en the deutue.ts found la the h 1 (4)> - . test wateret the test in paragrapin (d) of ~ rents; ,
manmarustessa amate-
- - Ememettdan 147 win not seeeed 44 m1Bi-i (6) Forst' ~ -of contained andleesttre zod per hour at 18 centiunstess heat any
. SIIs seeGee, er ff inses than 3,308 enda- , surtase ishest measured thsoush 50 antM-tapuamma per: estante .ef tuttausa ; or ansteries;- 'ts) absmistuma
. L r a. ! . e tsunpasegure withstood ' gasmsper samare sentimeter of absorher. ,.
i W Eds estthe Suer paper is # A . (d)"Ibemem-s==la= deteendnes that: panne" mad eher enF88 the tutets gases . destar pestetype taster - -(D The anothed of incors W and - : esaghs.te to:te af.Esentism.l'as 9(Y) nammsummmapuemassegraanianamager- %.t-. * . kindkagef the talttumm er promethinem 147 hMhe,-emmens n , my y ,a , gns prototype tests; p. a MWeesssed. .u... homu 'a(sys==hmmm redomettso nentertal; esameter 'afpremoottdema samtalmed :M7;udB In the met he devlee
=apa-n is sash that th ,
under me most essere e=ndi*nana wideh , u er q~ gy.ammamammenemy of am reso- are Mkely to be ananentered in nonmal
- J33A14 estive1mmesetts; and , ' ' . . t . 1t'
/ 1 3L ef < so- ng) W empatemos wth Sean- uerand handRas of the destes;
>1 ""an"
- 4 .
7 fr guisemamerEw.Esames s' Cemet deutses er semiassep amaymms tesesperated and . ..(SL The er emelesaden estissa erespreensthhsma tossestude M7 is
' An anr ua=*= See a enestes mamm= to .senstrumens "-* de,0ses, V- <y& 4' MW. W+ > erset pheulent anstaab ty.any parenst '
estatuto devlees, amadmenemy hyproduct ' . -
-Wdustned andmesusEnetured for 1"SMR. Eumnnaamielaumsdes seposes. ~ with it: . --(3) The device le so designed that it r
'the purpose of detecting. ====tng. iBinh Ma=== suthorised under'9 3BA1 m; and m .. e to estreute the dettees deserted Guerein aman =A enslW hs'"===-e Smagter er ematseAlmt a Steskasus,demnity,geset, haturgese mmmaann smentese,leektto generally Ignonsed persens sh
- eso, er geukseles er gundsteitse eheuni- ' (a) Report to theIIIrester,INvhten of and has satistaatcruy passed the proto-Esatorisas unenssanr. ETA. an==an muergy type tests ya ' by 5 32.141, ashed-
.>est eengesalonger ser puedesses agget atm-ese= san 1mestdagten,D.C.,305e5;an une B. . M :. ~ , , , N. ,
-er em tenAmed etungsgemme, to persums g,,, ,g,,g,, fg g,,g,,,,
sumeraRy. n=-ad under't EJ af, eds transeurs of each devises to persons gen- g ggfp esseptur45heopgesvedafr n r s :armIly Ma=mma under i 31A of tIds chsp- A passon Mesmeed under I33A3 ~to. t '(akTheespiteemtentesesstoesmeral :ter. Stadt . report shsE,tematify eneh y==nnemsk'"t, asemenble or;ansport de--
'segubestante apostBed A $1a.38 et mes *gamera1Mosmosebynameandaddrum,theehester; a mormEy . ;
see c--mm t
?(h) The appMeant subedts emmelmut ".Wy and type of hyprodinetamatesial een rM7 for hpahatinn to perggas geMannsad under i 31.7 o
-e.
AhSegutensa =mamaner :to J Guo. emisn," teamed in the esetens The esportahan hed withtm 30 days after the and ,eBr.
'e poetetype testime i .
Vesmess psessemos, leksMBE,M, queller-- embedtte<ef sesti eatender quarter in utdsh such . shakama Se manynnfh YessenSpotentist hengetetunedeedse sa4desteswas tressfetsed - .- , to essereRy li-JMesmas
- 4presermedmyIas. Stets) of taasetapter,y numberg ttsu .reeBatten wasm asasematie assusemos sets ; esamed messoms; and ' ' ' ,,
M SMSMSi&%dbrikwh+&a:b.~<MUW D sad k a ' ' " dE i==hO 5 g 9
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- ) ( y rmnmg . ,, , ,_ }
. Saturday, June N, IMS
,)
" FEDEltAL REGISTER 8195 18 4'
a statement that the device contains tested and rejected under the criteria 5 32.58 Same: labeling of devices.
, tritium or promethium 147, as appro- and procedures specified in this section. Each person licensed under 132.57 priate. and is generally licensed by the
< USAEC pursuant to i 31.7 of this chap- 8 32M Same: maten.a l transfer repons, shah amx to each source, or storage con-ter, and such other information as may Each person licensed under i 32.53 tainer for the source, a label which shall i be required by the Commission, including shall file an annual report with the Dl- contain suf!1cient information relative disposal instructions when appropriate, rector, Division of Materials Licensing, .o safe use and stcrage of the source If the Commission determines thatlabel- United States Atomic Energy Commis- and shall include the following state-ing on the device is not feasible and that sion, Washington, D.C., 20545, which ment or a substantially similar state. I an unreasonable risk to the health and shall state the total quantity of tritium ment which contains the information safety of the public will not be created, or promethium 147 transferred to per- called for in the following statement:
. it may dispense with the labeling of the sons generally licensed under i 31.7 of The receipt, possession, use and transfer 4
device on condition that a leaflet bear- this chapter. he report shall identify of this source, Model ...._.. Serial No. ......,
! each general licensee by name, state the are subject to a general ucense and the reg-ted e e n l ing closedtheinprescribed the containerinformation is en-in which the de- kinds and numbers of luminous devices N.ations o 1 ,g e vice is shipped. transferred, and specify the quantity of commtanton has entered into an agreement
, 9 32.55 Sames quality control; prohibi. tritium or promethium 147 in each kind for the exercise of regulatory authority. Do i tion of transfer. of device. Each report shall cover the not remove this label.
(a) Each person licensed under 132.53 [h1 " be filed CAtmON - ItADIOACTIVE MATERIAL - 1 0 Y8 "e8fte MS SOURCE M AES AMCM
! shan visually inspect each device and j shall reject any which has an observable $ 32.57 Calibration or reference sourece $1[3 of,rns ^ ^
CE physical defect that could affect con. corataining americium 241: require-ments for license to manufacture or tainment of the tritium or promethium __(Name of manufacturer or importer)_, 147 import. d) Each person licensed under i 32.53 An application for a specific license to are shall subject a number of devices from manufacture or import calibration or each production lot, sampled in ac- reference sources contatning americium Each person licensed under i 32.57 cordance with I 32.110, to the following 241, for distribution to persons gener- ahall perfe a dry wipe test upon each quality control procedures: ally licensed under i 31.8 of this chapter' source containing more than 0.1 micro-(1) Each device shall be immersed in will be approved if: curie of americium 241 prior to trans-30 inches of water for 24 hours and shall (a) The applicant satisfies the gen .furing the smrce to a general licensee show no visible evidence of water entry. eral requirements of f 30.33 of this under i 31.8 of this chapter. H is test Absolute pressure of the air above the chapter. shah be performed by wiping the entire water shall then be reduced to 1 inch of (b) 'Ibe applicant submits sufficient radioactive smface of the suce with a mercury. Lowned pressu m shall be information regarding each type of call- filter paper with the application of mod-matntained for 1 minute or until air bration or reference source pertinent to erste finger pressure. The radiom:tivity bubbles cease to be given off by the evaluation of the potential radiation on the paper shall be measured by using water, whichever is the longer. Pres- including: radiation detection instrumentation sure shall then be increased to normal exposure gg) .Cl $emical and physical form and capable of detecting 0.005 microcurie of atmospheric pressure. Any device which maximum quantity of americium 241 in americium 241. If any such test dis-
' leaks as evidenced by bubbles emanating the source. closes more than 0.005 microcurie of
~ from within the device, or water enter-11ng the devicc, shall be rejected.
(2) Details of construction and de- radioactive material. the suce shall be deemed to be leaking or losing ameri-sign. (2) The immersion test water from (3) Details of the method of incomo, cium 241 and shall not be transferred to the preceding test in subparagraph (1) ration and binding of the americium 241 a general licensee under i 31.8 *of this of this paragraph shall be measured for in the source, chapter.
-tritium or promethium 147 content by (4) Procedures for and results of pro- $ 32.60 Same material transfer reports.
an apparatus that has been calibrated totype testing of sources, wibh are de- Each person licensed under I32.57 to measure tritium or promethium 147- signed to contain more than 0.0W micro- ahall fil
. as appropriate. If more than 0.1 percent curie of americium 241, to demonstrate of the original amount of tritium or pro- that the americium 241 contained in rector
- visi o Ma Lice ' ~i methium 147 in any device is found to each source wH1 not be released or be l DC 54 ich s't ate h water, th sh " " * " * * ~
devi con tions use; g manufac of fw"an id each eneral b prometh! 4 { be measured. ' Any device which has a .(6) Description of labeling to be af- " bers of ' erred an [ radiation level in excess of 0.5 mtthrad fixed to the source or the storage con- the quan (in microcuds) of s per hour at 10 centimeters from any tainer for the source; americium 241 in each kind of source. I surface when measured through 50 (7) Any additional information. in- Rach report shall cover the calendar year [ mtflirrams per square centimeter of ab- cluding experimental studies and tests, and shall be filed within thirty (30) days - sorber, shall be rejected. required by the Cnmminalon to facilitate after the end of each calendar year. (c) An application for a license or for a determination of the safety of the amendment of a license may include a source ' S 32.70 Manufacture and distribution of ' description of quality control procedures (c) kach source will contain no more byproduct materiale for medical use
""I'r 8'"*'*I II'*"***
4 proposed as alternatives to those pre- than 5 microcuries of americium 241. scribed by paragraph (b) of this section, (d) The *nmminaian r determines, with An application for a specific license to
. and . proposed criteria for acceptance respect to any type of source containing distribute byproduct material for use by under thana procedures. The Commis- more than 0.005 microcurie of 'ameri- physicians under the general license of
.ston will approve the proposed alternative cium 241, that: ' I 35.31 of this chapter will be approved
? procedures if the applicant demonstrates (1) he method of incorporation and if:
%that they will assure the rejection of any binding of the americium '241 in the (a) The applicant satisfies the general N. device which has a leakage rate exceed- source is such that the americium 241 requirements specified in i 30.33 of this
')e ing 0.1 percent of the original quantity of will not be released or be removed from chapter;
~ tritium or prnmethium 147 in any 24- the source under normal conditions of (b) We applicant submits evidence hour period. . use and handling of the source; and that the byproduct material is to be (d) No person licensed under I 32.53 (2? The source has been subjected to manufactured labeled, and packaged in d . shall transfer to persons generally and has satisfactorily passed the proto- accordance with a new drug application - '
hanand under 8 31.T of this chapter any_ type tests prescribed by I 32.102, Sched- which the Comminaioner of Food and . y h=annan= safetF device which has been. une C. - Drugs, Pbod and Drug Niministration,. ), ' C.%p. mig % s.ks. -
~: X Lu,,z g g , . 3j
- ~.
.u . ;,9. ( . , .l g%
y.- % ~r - -m ewemy m gmydp my-- -yge # [j-- mp --~~-~q. ~ 4 ' > i 1 c.h RULES. AND RDOULATIONS ESSF a
- he . 4 er in accordance with a cury abeotute
- device shan pressure be manmn=d and stawn=ad under mese The con- both cording resonant and cycling to the fonowing Vibration conditions Test ac. .N Esenes for a biologic product issued by Schedule (Table D : .
es Se dit.ione.tw top a pusod or e nomi.. m t.mp.ne.se ome test ..m. m,,,cretary. Department of 2fes!th.
,,, ,,, m ,,,,,. 'c
'"""****8"
- Q 'Ibe foDowing statement.or a sub- theN YN ss nN o Tants: ,
stantfany afmflar statement which con- mercury ammolute pressure *=ad and stabussed. under these % % % , , ou, g % ! tains the informatema caDed for in the The=amaaa dettee eben be maine ser a parnod or so minutes. , foDowing -*-+=*nant appears on the label step 10 The internal pressure or the cham- vnrattne Vitrarlos y V1bration ammed to the mn+=tnae or appears in the her shall be maintained at 83 mtmmaters of Trpe $ leaflet or brochure which meenmnanfeg mercury abootute pressure and the tempers. . a n. C C - sure the package,* - ture reduced to +20* C. (68* F.) and sta- {
-'Ible radLametare drug snay be receivet under these htlized. The dettee conditione shanforbea malatained perice of 4 M """* j-W and used only by physicians it- m.,,, M""fo M""'"a u p I esamed to dispense druse in the practice or maurs. C"d ' - so u
- une and (b) Vibration tests. 'It!s procedure maad tmana gas roostpt. -- mj tranater ara sub}est to 'the rarnt=*wa and Applies to items of equipment (including -
nganarellicanoe of the United States Atomic vibration isolating assemblies) intended (1) Deterizination of resosance fre-snergy commieston or or a state with which to be mounted directly on the structure quency. Individua1rrannance frequency the meatcammwon ter the eseresse has entered into author-or regulatery an agree- of aircraft powered by reciprocating, surveys shall be conducted by applying turbojet, or turbo-propoler engines or to vibration to each device along each of 8'F- be maounted directly on. gas-turbine en- any set of three mutuaDy perpendicular
, ggormanurmerj gines. The device shall be mrgmtad on axes and varying the frequency of ap- e - $ 32f1 '
Schedule b-Prototype teete an apparatus dyn-=w.ny asmnar to the Piled vibration slowly through a range )j for '- ' m safety devices for use most severe conditions !!tely to be en.' of frequencies from~5 cycles per second ., I" *I"*f8-countered in normal use. At the end of to 500 cycles per second with the double - 1' An applicant for a license pursuant to the test period, the device that adaD shownbe in- ampm"6 in Figure I for of thethe related vibration not exceed 3 3343 shan sonduct prototype tests on spected thoroughly for possible damre. seek of Sve prototype liarminaus safety V!bration testa mhan be conducted under frequency. devlees Sur use in aircraft as feHows: ~ Mi . Jer-M-"""'" test. 'Ibc RESONANCE PREQUENCY HUNDREDS OF CYCLt3seePEA MINUrt Sydse theB he pinnad in sb teaMh s e o 12 to a,sse 4r sesegse g 13e ggg lesg gg g
,,,g,, , , , ,, ,gggg
- as MpeeldD used in servlee. ~ A tems. . 1.900 ,,, g , -
^
" - emanindan aahahta - 7 y_ . - ,
danB he ftausrod as.nmettnme in the Sol- , ' Egertag steps; ~ - ' -
~ step 1,; Tme sneernet . _. or me -
tout chammham shah be seemand to -Ss* C. - (-89* F.) send the devles chanbe madmaninae 9er a4 Emmun11mser at thes emmparatuse-at '
- P poemuma. = is
.. step S.'nns incarnal temaparature of the
-94*. C.
test shanker aban be raised. to .
' (-85' F.) sad maintatnad une the tempe.ra. g, Sure et me duelos her == man- og ~ge at stehmaphaste presome g-step s. The an====rh==== poemmune at the
= m ehamher absf1 be reduoed to 33 mnnen ama of * -
t sesseury an=an=*= psiasmure while the chamr " i O her temaparacase is unsteemamed at -Se* c. - ., * " - Samp en h teammaa tempassenare of taas w , =
a chaanhas shan to setsed to -10' O. (+14' F.) = n' . I ans ==amann==d unest ma temperature er ..
g
. Se GWhe kas samaammes etw30* C, and ' '"
4:to M peususoet eschamuturshast
- 73 ,, *
'(
p 3 Tess to egumene to asussaphases psesamme. - b '" - -
' r -
t ,m
, The test abasubur eeP sheet aus te .N .,
f an escur thes mass 1em sums em Mai * ~ h. , c aud' 8AMAR ====am geen w the ibust has - 1 ~ t . meessa has ass asas emmesh to allser the . 4,Mt maastaso to esmesumes. - Ths6 doce shan then - ' st az ascThe saternar temperatuse er me . .- . g _ , t
,= '
+ sheE te seeset to +G* O. (305' P.)
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- et the theseus short to mam os +3+ g. ~,- ' ~ 4 med unentmemed fers human.' The essess shall+J f thout te genaamp taspesend to ech the "
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= semp a The shamsher tumsperesure sha5 he - : i . -
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' man to stukseems as +w a ser a pursed at. .. ,
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- .n . o pareas er e nouse. y - % , ggggggggg,gytAGUE14Cf NCYCLES PER SECONS I soup s.The hemman temapematee as the 7,, .M,
. . j. ,
~ i =hama= shnu be reSuesd to +00* G.(85* F.) g,y FWaus 1-Asupttta.de el TGiratiest at seesnense ,
frequemey. ~ '
-aans me pseguume to 18E edm==*=== ef mer - - 7. . s_ , a. .,
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cpeannAL nestsinn sw?
-(f) Obserseness. After each of the dried or by measuring the radioactivity l.
(2) Resonsassiests. Thedsviceshan be vibrated at the determined remanane, testa pmscribed by this seouon, each de- in the residue obtained by evaporadon of the water in which the source was in j - ftDeuency for each axis of vibration for vice shall be amaminad for evidence of ,l the periods and temperature conditions physical damage end for loss of tritium mened. (e) Dry scipe test. On completion of shown in Table I and the applied er presnethium 147. Any evidence of dout$e amplitude specift in Figure 1 damage to or failure of any device which the preceding tests in this section, the for that resonance frequency. When could affect containment of the tritium dry wipe test described in paragraph (b) ;; more than one resonant frequency is en- or promethium 147 shall be cause for re- of this section shall be repeated. ' countered with vibration apphed along jection of the design if the damage or (f) Observations. Removal of more
- any one axis, the test period may be ac- failure is attributable to a design defect, than 0.005 microcurie of radioactivity in f ~ i compushed at the most severe reannance Loss of tritium or promethium 147 from any test prescribed by this section shah ' l or the period may be divided among the each tested device shall be measured by be cause for rejection of the source de- )
Issonant frequanetam, whichever is con- wiping with filter paper an area of at mitted sign. Results r of prototype to the 'nmmiaminn shall testa be given sub- 1 sidered most Hitely to produce fa!!ure. least 100 square centimeters on the out- i When resonant frequencies are not ap- side surface of the device, or by wiping in terms of radioactivity in microcuries
. parent within the specified frequency the entire surface area if it is less than and percent of removal from the total range, the specimert shnu be stbrated 100 square centimeters. The amount of smount of mdioactive material deposited ;
for periods twice as long as those shown trittum or pronnethfum 147 in the water on the source. for raannan,* in Table I at a frequency used in the hermetic. seal and waterproof i of 55 ercles per manan,t and an applied test prescribed by test paragraph (e) of Subport C-Quofity Control Sompung double amputnnla of 0.000 inch, this section shall also be measured. Procedures
. (3) CycHag. Devices to be mounted Measurements shan be made in an ap- yse-only on vibration isolators shah be tested paratus calfbrated to measure triuum or 8 32.110 cedures Quaky under control eertain an' pree E.
by applying vibration along each of three proenethium 147, as appropriate. The cenace, mutnany perpan,nandar axes of the device detection on the Siter paper of snore with anapplied doubis amplitude of 0.060 than 2,300 distategrations per minute (a) Each production lot of devices 11-heb and the freenener secting between of tritiums er pmmothiusa 147 per 100 consed under H 32.14'E 32 15 e, or m.53 le and 55 cycles per second in I-minute square cantimators of surface wiped or be sampled m acW m ahan
; - sycles for the Parands and temperature in the water of more than 0.1 percent of Table A in this section If the permissible anndatinna shown in 'Isble L Devices to the original amount of tritium or pro number of rejects spe'cified in Sampling 5
be installed in strerart 1stthout vibradon methinan 147 in any device shall be cause- Table A for a lot of that size is exceeded, leolators anall be tested by applying v1 for rejection of the tested device. all devices in that lot shall be sampled or i )10 bration i allong each of three esignaD $ 32,102 Schedule C-Prototye teste for the entire lot rejected. If ten (10) or perpandten1=r axes of the device with an appued double asapDtude of 0.03g inch
,.na,ation or seference someces com- more sucesssive lots have been tested taining annericium 241. and none of them includes a larger num-h a hm --at to her of rejects than spec 1 Bed in Rampung
. er en appRed aseeleration of 100,which- *
' * "
- I 32.57 shall,for any type of source which Tabble A, the =naaaading lota may .be !
betwee and 500 cycl is damirned to contain mon than 0.005 sampled in accordance wuh Sampling ; I ' per anmod in S-minuta cycIss for the microcurie of americium 341, conduct Table B in this section. (b) If any lot aampled in accordance posht ' and h mDeratura annnettana prototype tests, in the order Meted, en with narnpHnn Table B inahadas a lasser
* ' desnah'BelmI.
('1 idenstwahd MIests' 'the each of five prototypes of such source, Itussber of re$ests than sp= mad in j which.eentains more than 0.996 micro. Bampung Me B for a lot M that she, l devhe shnu h m'8tW h 30 hours d ctarle of americian 241, as fonows:
,amans weemerngen a euttshte -(a) Esitial mesesrement. '1he quan. au devices in that lot ahmH be amenpaad or .
4 weathering membha. Phaude d Orez D tity of radioactive material deposited on the entire lot rejected. Succeeding lots (
-shes shnu eersund to are h out of the seurae 3han be measured by direct seinII be ==paad in assordanas with the 4 hdebt reeeMut DEApr a wave- aanneene of the sensee. " i. prwTtelons of paragraph (a) et; his
- a; ' y i g 33 maysammens .Ibe Wht of . (b) ary ssipe test. . 'nie sntire radio- ='e=
, nn yq h.ee senten esse esRteE Men es -pseneTalde A: ,
s X tes et'en deste 'Ebe *===r==8m== at aaths. when utth smtesa me=r of .the went paper soume theshan appit-he ' je)
> -Se assett est be eenksheet et 80* C. estion of moderste Baser pronum. - Re- ~
. . Permessen . +
' pits er satees s' C. Tseuserseers seeee- sesset of seeemettee matament fresa the ..
;Istshe' emaste sass ,namnerer
- 9'"
,' urunents char he made WWE s timek source stimE te deter-enas by measuring
'j .. paent 8ma======r=*== .o.!
. . ^ < ;
. ,7
, (d). Seek test . 'I3te deslea shan he . the ranHamenvhr en me Ahur pap.,,am,gg,, erby diruet maassement of,wthe redigmo 3 _g,_ '
deepped impen a semeesta er frem eurtees 137 tty on the acetree SoDowing the dry agy i-m i '
'o h aa,4est hee psenstlemal teR, er absE =1pe- .
mi-ame. m * , . " .-s - l, nhetest sietested to s edenhas emmany e ansmanny seek a noe teR. . (c) Wet si.=en deeges.am asipe test. The entire radio; is
,g *ma s
# active surface of the souses shaR he Q38,, - ,,
ante drop test shnB to rupested ISS Mmes wiped with altar paper,innantenad with s,mi-a = ses r froms rendees ==e==q,an ; water, with the appua=8 tan et anoderate e,mi-a.on me
- 1 . (s) Nerenades asetend samfarproof test. Anser pressure. Removal of reditastive ,
On aa==pI=Ha= d eR ethes tests pre. material from the source shsH be de- '(d) Ramp 3tarThbleB: ~ " ~ . ~ ' T oerted by th esseeab en ervios shaR tarneinad by mammuring the radioactivity i h, guessened h 3D hatus d water for on the Siter paper after it has dried er ,,,,,,,,,, 30 homes and sher show as sishle evt. = hy disset ====wement of the radioac- ', . Ist sean easmah sees === ni- or russies
-l , denes et the of airwa4Ee above me
' 'M ' J =rdumed to 1 Imak of === man =F amens, wetseAkambda shaR thenpressure he Edusered wipe. livity on the source foDowing the wet a An o (d) Water soak fest. '1he source absD ' tem than ;
>$mguessere s a h
men hdahnes em w ser he. 1 m.en. w i---- a m water at ro
.en tanpa e=m -:.
er .h es e,e heR e .maw se,,,wk ns se., h e.e h or. ture s. ror a perhd=of m oonmouu ya nem een n. .ehe .m=, m .or . . j J ' mal 6 .peemuss Amy erldenee 'rhe' sour = een u== m usamved e femthe water. . sHemoral p, c- . s at radione
, j.
L? ~ d $ $ blem hemt SMdm Se tertal from the source shan he deter ,- 4g 'j l hadsudge, shad Jtnised by emot measuromuest af tho' a -- '== m ' 6 vd 1seter se 'i. M }'t0 M saecesuttyest es eeune after at has ' Av" '= E Dyggy m 3.h
.f ReL-v:w eins;-e w g $ [SQ w s w wl9hakage, +m v , , _
m %dw,?x&h&
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l 8198 RULES 'AND REGOLATIONS [ Caoss arrrarwcx TuLa prove, in advance of purchase of radig- 9 34.1 Purpose and scope. oh! secten isotopes, proposals for such uses; and S 7 New secrton This part prescribes requirements for . (d) The applicant has appointed a the issuance of licenses for the use of
- 32.1 -- ............. New 32.11.... ... . ....... . .. ....-. . so 2 4 ( h ) ( 1 ) radiological safety ofncer who will ad- i r 32.12. - -
- 30.24(b)(2) vise on or be available for advice and sealed sources containing byproduct ma-terial and radiation safety requirements l l'
, 32.t3 .. ......._ _. 30.32 ( r ) assistance on radiological safety prob- for persons using such sealed sources in 4 i
- 32.14: _
_ . 30.24(l) 3'"8- 1-32.15 __so.24 (m) (1) (1)-(17) radiography. The provisions and re. j 32.16- O- so24(m)(2) $ 33.12 Licenses for muhiple quantities quirements of this part are in addition . 32.17- . so.24(m)(3) or types of byproduct material for to, and not in substitution for, other re-
$#y]
2 se a pr ce*8 ng- quirements of this chaptet. In partic- 4
$"_ ~~" An applicauon for a specific license ular, the provisions of Part 30 of this -
e 82.40 so24(m) (1) (v) (a)-(e) 32.51 .. so24(r) for multiple quantities and types of by. chapter apply to applications and licenses i 32.52 . 30.32(e) product material for use in processing ior subject to this part. Nothing in this part
- 3233 80240)(1)(1)-(17) distribution to other authorized persons shall apply to uses of byproduct material 32.54 3024(J)(1)(vil will be approved if: for medical rhen* or therapy.
8 32 - (a) he applicant satisfies the gen- $ 34.2 %finitions. .
\
, eral requirementa specified in i 30.33 of
' ' this chapter; and As used in this part: l 3 30 (n)( ta) " Radiography" means the exami- ' -
! 32.50_ - -
30.24(n) (3) (b) The applicant has received a rea , 3220 -- 30.24(n)(4) sonable number of licenses for process. nation of the structure of materials by 32.70 ........ so.24 ( k ) ing and distribution of a vari ty of radio- nondestructive methods, utilizing sealed j s2.101 so.24(j)(1)(v)(s)-(f) isotopes; and sourc of hvnmdm t Inaterials; , s2.102_ _ so.24(n)(1)(v) (c) The applicant has a apolated (b " lographer" means any indi. l l 32.110 - 30.25 radiological safety ofBcer who will advise who performs or who,in attend- l j on or be available for advice and assist. ance at the site where the sealed source I PART 33--SPECIFIC LICENSES OF ance n radiological safety problems. or sources are being used, personally supervises radiographic operations and j BROAD SCOPE FOR BYPRODUCT Caoss arruxxwcz TaaLa , gg g g g j MATERIAL , New section OLf section suring comphance with the requirements g,,, 33.1 _....___ _ New of the Comminion's regulations and the
~~~~~~~~~- -***-- 8 S4 conditions of thelicense; 33.1 Purpose and scope. 2 ,
(c) " Radiographer's assistant" means
~
asemaruxwn rom Brucmc ucruszs any individual who. under the personal 33.11_ ucenses for multiple quantitles or t types or byproduct material for use PART 34-LICENSES FOR RADIOG. supervision of a radiographer, uses radio- . in research and developtnent. RAPHY AND RADIATION SAFETY graphic exposure devices, sealed sources 33.12 ueenses te multiple quantitles or e nla ed handung tools, w radlauon j types at byproduct material for use REQUIREMENTS FOR R A D I O- survey instruments in radiography;
; in proce==tnr GRAPHIC OPERATIONS (d) " Radiographic exposure device" Avutoarry: 'Its proviatons of this Part 33 Bec. means any instrument containing a h - Issued eder see.1st, es Stat. 948; 42 UE.C. 34.1 Purpose and scope. sealed source fastened or contained I - 2201, hterpret or apply secs. s1. Is2,18s. 34.2 DefLntuons.
therein, in which the sealed source or
; 68 8 tat. 935, 96s, 954; 42 U.S.C. Sill, 22:2, 34 3 Appucauona for specinc Mcenses. shielding thereof may be ' moved. or subport A-speciac Ucensins Requirernents otherwise changed, from a shielded to
[ unshielded posinon fw purposes M inak-p 9 33.1 Purpose and scope. 34.11 Issuance or specine neenses for use or ing a ographic exposm, t his part prescribes requirements for
- sealed sources in radiography.
the msu c censes subport B--aediation safety Requirernents p uct rial that is encased in a g and f{ '. regulations governing bolders of such [ Moenses. 'Ibe provisions and require. 3431 Ltmit RemrMENT CONTaof. on levels at radiation forstorage Capsule designed to prevent leakage or , radio- escape,of the byproduct material, ! I
._ graphic exposure devices and s (f) Storage container"Ineans a de- l vice in which sealed sources are trans- l -)
f ' ments and not of in this part are substitution in other for, additionre to' 34.22 o ntainers. radi 8 P ted a stored, 1 quiram,nts of this chapter. In particu- j t s ormse oo i lar, the provisions of.Part 30 of this 342s Sto-age precauuons. I 34 3 APPlications for speci6c licenses, ' chapter apply to applications and same nadiation survey instrumenta. '
' Applications for specific licenses for ' - licenses subject to this part.
RaammEntEwis roa SPECIrIC LICENSES 3435 Lena testing, repair, tagging. opantw. use M sealed sources in radiography shan f eq p h ent W be filed on Form AEC 313R," Application :
'l g 33.11 ucenses for anhiple quantitles semsluart=1r Inmicry. .fw Byproduct Material License--h d l
&aled Somes in Mography.
,j or types of byrredact matedal fee am Unusmuon logs. ;
use in research and development. Punsomar. RADIArtoN SArrrr REQmaEMENTS Subpart A-SpecHlc Licensing ! axis namsmarMus- Requirements An appucation for a specific license ",,,, 3 aanroonAraxas
,,, ; l for multiple quantities or types of by-product material for use in research and 8421 umitatsona 6 34.11 Issuance of speci6c licenses for develcpment win be approvedif: 3422 operaung and mergency 5 Ms use of sealed sources la radaagraphy.
s423 Pemanelinonstoring control.
- M 'Ibe applicant antinflee the gen- An application for a specifle license for ermi requirements specified in 5 30.33 of PascAurtowami Paocunvans tw RADIoGaArmc use of sealed sources in radiography will this chapter; and ,- orrmanns be approved if: 1 (b) 'Ibe applicant has received a rea- 34.41 Security. (a) The applicant satisfies the general - T 34.42 Posung. requirements specified in i 30.33 of this I 'sonable of radw^ number pes forofalicenses variety offor a variety researth 34.4s Radlauon surveys and survey records chapter: W, L. and development uses; and .
xxxMrrious (b) The applicant will have an ade- . b (c) ne applicant has established an 84.51 Applications for exempuona. quate program for traintnr radiogra-f lsotope enmmtttee (composed of such , Appendix A. m phers and radiographers' assistants and i ~ persons as a radtological safety ofnoer, 3 ,, ,,,,;,6 m p.,ds submits to the (Mmminstem a schedule or b . noresentauve of the business cance- assusa under aso.1st, es 8 tat. 94s; 42 US.c. See description of such program which spect-j and one or mon persons trained or ex- 22o1. Interpret or apply anos. s1. Is2, iss, the: ' p portanood in the safe use of radiaartive as east. 985, Des, 964; 42 US.C. 3111, ases, i (D Initialtraining
* : meestlais) which will review and ap- - 22s3. -
'(3) Periodictraining; '
.a. C *
-m m.- .
s
, 8199 3
[ Saturday, June 26,1965 FEDERAL REGl$iER i (3) On-the-joh training; authorized or accidental removal or ex- r%=mwinn, Washington, D.C., 20545, .,y (4) Means to be used by the 11censee to posure of a sealed source and shan be describing the equipment involved, the [i determine the radiographer's knowledge kept locked at an timas except when test results, and the corrective action and understamunr of and chility to com- under the direct surveulance of a radi- taken. A copy of such report shan be ply with Cammen regulatinna and H- ographer or radiographer's assistant, or sent to the Director of the appropriate 3 censing requirements, and the operating as may be otherwise authorized pursuant Atomic Energy Commfuton Regional
}
and emergency procedures of the appli- to i 34.41. Each storage container like. Compliance Omce listed in Appendia D cant; and wise shall be provided with a loch and of Part 20 of this chapter **8tandards l (5) Means to be used by the licensee to kept locked when cont atnimr sealed for Protection Against Razitation." determine the radiographer's assistant's sources except when the container is (e) A sealed source which is not fas-knowledge and understanding of and under the direct surveinance of a radi- tened to or contained in a radio-abihty to enmniv with the operating and ographer or radiographer's assistant. graphic exposure device shall have per-manently attached to it a durable tag at (j emergency procedures of the appucant; 9 34.23 Stocage precautions. least one (1) inch square bearing the prt-(c) The applicant has estabushed and U submits to the Commiuton satisfactory Locked radiographic exposure devices scribed radiation caution symbol in con-
^' written operating and emergency pro- and storage containers shall be physically ventional colors, magenta or purple on cedures as described in i 34.32; secured to prevent tampering or removal a yeDow background, and at least the td) The app 3 cant win have an ade- by unauthorized personnel. instructions: " Danger-Radioactive Ma-
, terial-Do Not Handle.-Notify Civil Au-quate internalinspection system, or other 9 management control, to assure that 4 Rassen sum inemnnta. thoritiesif Found."
Comminion Ucense provisions. Commis. The Ucensee shan maintain suf'icient I D*""U I" '"U" sion regulations, and the applicant's op- calibrated and operable radiation sur- Each licensee shall conduct a quarterly
' erating and emergency procedures are vey instrumenta to make physical radia-followed by radiographers and radiog- tion su7eys as required by this part and physical inventory to account for all Part ll0 of this chapter. Ench radiation sealed sources received and possessed
, raphers' assistants; (e) The applicant submits a descrip. survey instrument shall be calibrated at under his license. The records of the tion of its over-all organizational struc- intervals not to exceed three (3) months inventories shan be maintained for in-and after each instrument servicing and spection by the Commiulon, and shall ture pertaining to the radiography pro-gram, including specified delegations of calibration.
a record mainMnad of the latest Instrumentation date of product required include the quantities material, and kinds location of by-of sealed authority and responsibility for opera- by this section shan have a range such sources, and the date of the inventory. tion of the program; and (f) he applicant who desires to con- that two miniroentgens per hour through 93L27 Utilization legs. duct his own leak tests has established one roentgen per hour can be measured. Each licensee shall maintain current adequate procedures to be followed in 8 -
# * .""* ' ' " ' *ssins. logs, which shall be kept available for i leak testing sealed sources, for possible Wn Wn 845 n 88d' *FeP l a* inspection by the Commluion at the ,
i leakage and contamination and submits * ' "' 8' ' * *
- address specified in the license, show- .
! to the Commininn a description of such (a) The replacement of any sealed ing for each sealed source the following .
procedures including: source f astened to or contained in a radi- infonnation: (1) Instrumentation to be used, ographic exposure device and leak test- -(a) A description (or make and model (2) Method of performing . test, e.g., ing, repair, tagging, opening or any number) of the radiographic exposure points on equipment to be smeared and other modification cf any sealed source device or storage container in which the method of hking smear, and shall be performed only by persons spe- sealed source is located; (3) Pertinent experience of the person cifically authorized by the Commtuton (b) The identity of the radiographer who will perform the test. to do so, to whom assigned; and (c) The plant or site where used and Subport B-Radiation Safety (b) Each sealed source shan be tested Requirements for leakage at intervals not to exceed a dates of use. # months. In the absence of a certificate PrtSoNAC RADIArIoN SArrry Rzetmtz-Emxn r CONram from a transferor that a test has been wzwis rom RADroGRArHERS AND RADIoc- - 63L21 Limits on levels of radiation for made within the 6 months prior to the EAPHERs* ASSI$ RANTS radiosraphic exposure dences and transfer, the sealed source anall not be 9 34,31 IJmitations. storage containers. put into use untu tested. (c) The leak test shall be capable of (a) he licensee shall not pennit any Radiagrchic exposure devices mess. uring less than four (4) inches from the detecting the presanea of 0.005 micro- person to act as a radiographer until sealed source storage position to any ex. curie of removable contamination on the such person: sealed source. An acceptable leak test (1) Has been instructed in the sub-I terior surface of the device ahan have no radiation level in excess of 50 milH. for sealed sources in the possession of a jects outlined in Appendix A of this part l roentgens per hour at six (4) inches from radiography licensee would be to test and shan have demonstrated under-any exterior surface of the device. at the nearest accessible point to the standing thereofi- { sealed source storage position, or other (2) Has received copies of and instrue- - Radiographic exposure devices mammur. I ing a mtntmum of four (4) inches from appropriate cedure to bemewwing approved point, pursuant by to a Ipro- tion 34.11 part in and the regulations contained the applicable in Part sections of this the sealed source storage position to any (f). Records of leak test results shall 20 of this chapter, AEC license (s), and exterior surface of the device, and all storage containers for sealed sources or be kept in units of microcuries and main- the licensee *s operating and emergency for radiographic exposure devices, shan tained forinspection by the twnmiente pivcMum, and shan have demon-(d) Any test conducted pursuant'to strated understanding thereof; and have no radiation level in excess of 200 (3) Has demnnstrated competence to miniroentgens per hour at any exterior paragraphs which reveals (b)the andprmence (c) of this of section 0.005 use the radiographic exposure devices,
- surface, and ten (10) mintroentgens per microcurie or more of removable radlo- sealed sources, related handling tools
! hour at one meter from any exterior sur- active material shall be considered evi- and survey instruments which will be
' face. The radiation levels specified are with the sealed source in the shleIded dence that the sealed source is lenkinF employed (b) heinlicensee his assignment.
shall not permit any The licensee shall immediately withdraw (Le., "off") position. the equipment involved from use and person to act as a radiographer's assist- S , s 34.22 Iocking of radiogr.phic ex- shall cause it to be decontaminated and ant untu such person:
, posure devices and storage contam- repaired or to be disposed of,in accord- (1) Has received copies of andinstruc-
**** ance with Commi=ie regulations. A tions in 6he licensee's operating and i
) Each radiographic exposure device report shall be Hled, within 5 days of the emnergeno procedures, and shan have
{ shall be provided with a lock or outer test, with the Director Division of Ma- demonstrated understanding .thereof;
- locked container designed to prevent un- terials Licensing, US. Atomic Energy and '
4 h e
. ., + . - r- . :g. 3
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~
I RULES ANO ~ REGULATIONS ~
' ; '% b w d [.,7" j
[880b i '(3) Has demonstrated competence to ation area is equipped with a control caoss itsruname Tanz. ' use under the personal supervision of the device or an alarm system as described in New eseHon old ecchon ' 'radiographor the radiographic exposure I 20.203(c) (2) of this chapter, or (b) 34.1 ."" - - ~
....'.'.".."((.'M's"(~a") yew devices, sealed soultes, related handling where the high radiation area is locked
- tools and radiation survey instruments to protect against unauthorized or accl. 34.s 34.2-
-(t)
_ _ _ New i l.
- which will be employed in his assign- dental entry. 84.11- --- . so24(g)
' ment. 3421- 31,103 .8M
$ 34.42 Posting. 3422 _ - 31.102
- $ 34.32 operating and emergency pro. 34.23_ 31.103 . -{"
w ,,,, Notwithstanding any provisions in 34.24 . ... 31.104 I 20.204(c) of this chapter, areas in P4.25... - .- _ 31.105 The licensee's operating and emer- which radiography is being performed 34.26. ...... 31.106
- gency procedures shall include instruc- ahall be conspicuously posted as required 34.27.... a1.107 . a by I 20.203 (b) and (c)(1) of this chapter. 34.31 31201
- tionsin Etleast the following:
3422- 31202 (a) De hanew and use of licensed
.... s120s sealed sources and radiographic expo- 9 34.43 Radiation surveys and survey 84.33
~
records. -_ 81201 sure devices to be employed such that no , person is likely to be exposed to radia. (a) No radiographic operation shall be 34.437"~'" tion doses in excess of the limits estab- conducted unless calibrated and operable 34.51-3
..... ... 81.401 l
'11shed in Part 20 of this chapter " Stand- radiation survey instrumentation as de- Appendix A... - Appendix A. Part 31 ! '1 I 'ards for Protection Against Radiation"; scribed in i 34.24 is available and used at J (b) MIthods and occasions for con- each site where radiographic exposures ~i ' ducting radiation surveys; . are made. PART 35-HUMAN U$ES OF : (c) Mzthods for controlling access to (b) A physical radiation survey shan BYPRODUCT MATERIAL ] radiographic areas; be made after each radiographic expo- Bec. , (d) Methods and occasions for locking sure during a radiographic operation to s5.1 Purpose and scope. 3 ' and securing radiographic exposure de- determine that the sealed source has ass Teense requirements. t q 352 Denniuons. .g
- Vices, storage containers and sealed been returned to its shielded condition.
sources; (c)* A physical radiation survey shall arnetrac Laczussa i
- i (s) Personnel monitoring and the use be made to determine that each sealed 35.11 specla " "~
of personnel monitoring equipment; source is in its shielded condition prior product i tu . (f) Transporting sealed sources to to securing the radiographic exposure de- 85.12 specine ucenses to individual physt.
- field locatiana. including packing of vice and storage container as specified clans for bnman use or byproduct
. radiographic exposure devices and stor- in i 34.22. material.
- aga containers in the vehicles, posting (d) Records' aball be kept of the sur- 35.1s epecine ucenses for human use of by. ;
product materkt in sealed sources. l of vehicles and control of the scaled veys required by paragraph (c) of this
- sources during transportation; section and mint ^inad for inspection bY -
Oswanas. Iacumsus M3 (g) WmW exposure of persons in theCnmmleion. l ' the event of an accident; . 83M 0"al ucenas for medual use or j h mions. Um product- ,i (h) The procedure for notifying . terk1} '
- proper persons in the event of an acci- 6 34.51 Applications for exemptions. Amoarrr: The provtsions of this Part 35
- dent; and The Comminainn may, upon applica- issued under sec.161, es stat. 94s; 42 cac.
i
'(1) Maintenance of records. tion by any licensee or upon its own 2201. Interpret or apply sees. 81. 182, 183. . ,e l 8 34.33 Personnel monitoring control initiative, grant such exemptions from es 22ss.
stat. os5, ess, est: 42 Up.c. 2111, 2232, 3 l the iwuh-ents of the regulations in . Ja). The licensee shall not pe'rmit any this part as it determines are authorized 8 35.1 Purpose 'aaul scope. , Person to act as a radiographer or as a by law and will not result in undue This part prescribes regulations gov. radinerapher's maniatant unless, at all s
- times during radiographic operations, hazard to life or' property
- erning the '1 censing of byproduct mate-Arrtumz A
^
rial for human uses. It includes specin] t each such person shall. wear a film badge ! and either a pocket dosimeter or pocket AWub=ents for issnawa of specific 11 - I. Fundamentals or radlauon safstr. censes authorizing human use of by. s chamhar. ; Pocket dosimeters and pocket A characterisuesof Fam= radiation. F mhamhers shall be mapahla of measuring s. Units or radiation dose (mrom) and product material, general licenses for l doses from sero to at least 200 mHll- quanuty of radf r activity (curte). human use of byproduct material cf , l rosentgens. A $1m badge shall be as- C. Hazards of excessive ' exposure of specified types and !Orms, and certain regniatiana governing the holders of ( l signed to and worn by only one person. radiation. -
* ***d such specific and generalite=naan - The
[ (b) Pocket ~ daalmaters and pocket ,,g*L' ' 8' D ' '*d1*" " 8" pm and iMMts of this part l
- ahamhers abaB be read and doses re- E. Efethods of controLung radiation does. are in addition to, and not in subsutu-i corded dany. A film badge shall be im- 1. working uma.
, tion for, other requirements of this chap-i mediately prar*amad if a pocket chamher 2. working distances.
or pocket dosimeter is discharged beyond s. shielding. . . . ter. In particular, the proviniana of Part " I tes range. 'nte film badge reports re-II. Radlauon detacuan instrumentation to M of this chapter apply to applications andlicenses subject to this part. j eelved from the film badge processor and beA. used.
- Use et :=dsattaa survey instruments. , , _
' records of pocket daalmater and pocket ^ '** ~ chamher readtnga shaU be maintained ! for inspection by the Commtmainn. k
- s. umie.unn, No person suMeet to the regulations in - d
. B. survey techniques. this chapter shall receive, possess, use or
[ r. Pascansar Psocams a c. Use or personnel monitoring equipment, transfer byproduct material:for ,any
- [' Itassossarstsc;Orskarsosts 1. Fum badges. human use except in accordance with a
' 2. Pocket dmf =mters specific or geneml license isNed pur-6 34.41 Seenrity'. ,
- s. Pocket Am=h-s. suant to the regulations in this part and -
During each radiographic operation ~ III. ***armphne equipment to be need. Part 30 of this chapter or with an ex-the radiographer or radiographer's as- ' Am.mornote handn=f equipment. ~ namm esposure devtees-emption under Part 30 of this chapter. sistant shan maintain a direct survell- a - lance of the operation to protect against .g "g, N'or perunent Federal 5 35.3 Dennitions. -
'unauthorimod entry into a high radi- Besulauona. _ As usedinthis part:
atten area, as dannad in Part 20 of this v. 'ste neenese's written operaung and _( a) Human use" means the internal , or external administration of byproduct chapter, except (a) where the high radi- emergency procedures. s
< -y -
.l {
mm r c c. _ . Y s.P '* ,Y< $ . h e i f s f u
, R. . ,, ,m-.,w.,.,.., -- , 3 .g } }}
;BefArdaiy, June E IMS -FEDERAL REGISTER p ' '
*~
83M %;; (a) Th3 appucant natianma the gen- cine, and speelfydeg the lisense munber J usatorial,' or the radtmalaa therefrom, to 4 human beings; eral requirements specified in f 30.33 cf and the Etate in which such license is ,
. (b) "Phyeleian" means an individual this chapter; and valid; and )
llamamed by a State or territory of the (b) 'Ihe applicant or, if the applica- (3) A statement that the registrant United States, the D6 strict of Columbia tion is made by an institution, the in- has appropriate radiation measuring in-or the Cammanwealth of Puerto Rico to dividual user (1) has specialised training struments to carry out the diagnostic ;
! dispense drugs in the practice of in the therapeutic use of the radioactive procedures for which he proposes to use I medicine. device considered (teletheraps unit, beta byproduct material under the general '
i appilcator, etcJ cr has experience equiv. 11 cense of f 35.31 of this chapter and i SescIFIc Lrcsivsss alent to such training; and (2) is a that he is competent in the use of such - 1 '
} . $ 33.11 Specific licemmes for human u** physician. Instruments. I of hyp:oduct masternal in institutions. (c) A phystetan who receives, pos-g l An application by an institution for a 6WIof en%nal heense for mMical use sesses, tain quanthree of byproduo ing byproduct or uses amaterial pharmaceutical pursuant contain-to the ,
i specinc Moense for human use of by- "*""'I" general license established by paragraph { product material wil be approved if: (a) A general license is hereby issued (a) of this section shall comply dth [. (a) he applicant satisfies the general I requirements specified in i 30.33 of this to any physician to receive, possess, the(1)folloring: He shall not possess at any one 1 chapter: transfer, or use for any of the following l 1 (b) The applicant has appointed a stated diagnostic uses,in accordance with time, purruant to the general'heense in l medical isotopes committee of at least the provisions of paragraphs (b), (c), paragraph (a) of this section, more - l j l three mmmbers tu evaluate all proposals and (d) of this section, the following than: (1) 200 microcurias of ladina 131, for research, diagnosis, and therapeutic byproduct materials in capsules, disposa- (iD 200 microcuries of todine 125, l use of radioisotopes within that institu- ble syringes or other forms of prepack. (fil) 5 sdi.wh of cobalt 58, tion. M*=nharahip of the enmmittee aged individual doses; (17) 5 microcuries of cobalt 60, and abould include physicians expert in in- (1) Iodine 131 as sodium iodide (v) 200 microcuries of chromium 51. - ternal unedleins, hematology, therapeutic (NaI183) for measurement of thyroid (2) He shall store the ph.- ccutical 1 radialary, and a person experienced in uptake: until administered in the original ship- ; assay of red alantepes and protection serum (2) Iodine 131 as fodinated human against tanishw radiations; albumin (IHSA) for determina- ptng container or a container providing . 1 (c) The applicant possesses adequate tions of blood and bbod plasma volume; equivalent (3) He shall radiation use the ym6X.vu, pharmaceutical l
' facilities for the clinical care of patients; (3) Iodine 125 as Mnabd human
}
(d) he physician dae=**d on the serum albumin (IHSA) for determina. only for the uses authorized by paragraph l application as the individual user has tions of blood and blood plasma volume: (a) (4) of thissection; He shall not administer the phar-substantial experience in the proposed (4) Cobalt 58 for the measurement of use, the handling and administration of intestinal absorption of cyanocobalamin; maceutical to a wnman with confirmed radioisotopes and, where applicable, the (5) Cobalt 80 for the measurement of pregnancy or to a person under 18 years 4 diinical manarement of radioactive intestinal absorption of cyanocobalamin; of age; (5) He shan not transfer the byprod-
. l patients: and (6) Chromium 51 as sodium raelo. uct material to a perman who is not au- 4 I
~(e) If the appliention is for a license chromate for determination of red blood thorised to receive it pursunut to a li- r
' to tre urugseelfled quantities or multiple cell volumes and studies of red blood cell eense issued by the nanmimmian or an , l types of byproduct material, the appli- survival time. agreement State, or in any mannar other -
)
I cant has previously received a reasonable S' ; ink =* lad snipping
*8I 1D*M' D than in the unopanad ; ' I number of Deenses for a variety of by- ds #U
[ product materials for a variety of human which are under the senermi tionnee in this h ",3, g, , p gg, . , uses. paragraph to include the tonowing statement (d) The registrant possessing or using . in the labet amned to the container co m the
==een sne hyproduct masterial under the general ;~
$ 35,12 lacemese to individual leanet or brochure which Meense of paragraph (a) shall report in ph 5er humaa - of hy. ,,mnpwo ,u: ;
prodon maten,al, ,
,Inis rmalemettre drug may be received, dupliente to the Direstor. Diviston of An application by an individual physi- posseemed, and used only by physteisme 11 , Matarials Iamenmhng, esty ghangesinht the the e"'*d ** "r-== drume la the practice of e.nformation Eagletratten furaimbed by hhn i
l clan for a spec 1Sc license ser hasutan use eine. Its teetipt. P . uns,and CertBSeate-3Gedsel Use i of byproduct material will be apptWed tranater am euweet to tne regnh and of Erproduct 38aterial Under General , I , a emnerailleense or the United states Atomic T **n==," Pbrta ABC-4st he soport
} gg-. (a) De applicant satteSes the general miersy coen=tamaa or or a state with whten anan be -- witan so dare afte -
requirements pa mad in in.3: of this ment the n-i im- ans entered into an agn,e-for the eseretse or reguistory enthority. the effective date of such chante. ekspeer: * (e) Any pe son undnt byproduct ma- i (b) The applicant has access to shos. ' . iname or manuraecurer) terial pursuant to the steeral Boonse of
*pital possessing adequate facilities to
-tespitalise and monitor the app!! cant's (b) hMianshanreceive, possess narmaraph (a) of this sectica la exempt e -
PaGonettve patients whenever at ps ad* use* en transfer byproduct material pur; . fromL chapter the with may*=mants respectoftoFart theSB of this g hyproduct VIIshier and sna dt ter the general Meanse totahtished materials cavesed by the generallicense. 2
'(e) De applicant has extensive ex- by paragraph (a) d this secuon until he 2
.perience in the proposed use, the han- has Sled phrum aw aas "Begistration ' . . .. cease muassener Tessa
?
ditar and administration of radiasma. CertiSeathnieGeel Dea _ ef Eypr.oduct ##" 8 ##8 03# **##"" [ topes. and where applicable, the cliaisal gg,g,,g g gege, g,,,,,g y,,,, with 35.1--
. management - of radiaeuve pattants. g, m, m g ag g,g,g, g
.".E- - - .s.. [N
~
ghe phystaten shall furnish suitable evi- manning. U.S. Atenklo Energy Comunis- [ so. ketal ~nd so.st(s) .- ($ ' h of each w-- with his appH* alon, Washington. D.C., 20645, and re as.it- . so.sstal antion. . A statessent freen the medical ceived from te ni===I=taan a vandaud 35.12 - 30.3sto) isotope agn=tteee in the institution copy of the Form m with registra. as.ts. - mp .% where he acquired his ernaria . in- tion number ammtenad. 'Ihe registrant asJa '~ 6 Genting its aseount and nature, may be shan furntah on Phrm ABC-402 the fol- - h-seekmitted per e==na y an evidena et such as* lowing formationinformation as mayand such other be required in. PART 36-RXPORT'AND IMPORT OF by that
. $ 35.13 . Speams Ecenese for h- see form:
' - BYPRODUCT MATERIAL m et typeednet . usessial ,Ia osaled (1) Name and addrues of.the regis ' ,,, - ~
emesses, trant; - sei Purpees and esopol An appuestion for a speeMic 11amn== (2) A statement that the registeant is sas a====*=**=== J . for use of a sealed source for hamnen use a duly licensed attystelen authortsud to ses 14eense require:nente matertal. for export or by. g dispe:Ise drugs in the practice of medi- product 1wS1 he approved if: m2
^A* .6% . .
8
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. _ _ ~ ,_ __ _ . _ _ _ .- - _ _ _ _ _ _ -
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8*02 - RULES AND'REGULAMONS 3 ~v 4 ' -
/
g d - erneme tacusas Bieczrto Ltcasas " 2.5 mIUlcuries of tritium per Uter of he- 7l 36 1'1 App 11 cations for specine ticenses. $ 36.11 Applications for speelne II. ) person expo; ting byproduct ma-
- l' 36.12 1ssuance of specine incenses for export censes. ^
of byproduct material. terial pursuant to the general license l Applications for specific lleenses for established by paragraph (a) of this sec. ~1 - omsmas. Licuars export of byproduct material from the tion, shall file with the Conector of Cus- ' United States aha.n be filed in triplicate toms, or the Postmaster, one copy, in M .d si 36.21 Export of certain byproduct material on Form AEC-7 with the Director, Di- addition to those otherwise required, of "I i to countries other than Schedule A vision of state and Licensee Relations, the Shipper's Export Declaration cover-so J2 Ex of certain quantitles of trit-M.A c hemy M**n, WM- ing each export, maded for hansmMal f"
; i tum and polontum 210. ington, D.C., 20545. Applications may to the Director, Division of State and ; i 36.23 Export of americium 241. also be filed in person at the Commis. Licensee Relations, U.S. Atomic Energy -
sion's 021ces at 1717 H Street NW., Commission, Washington, D.C., 20545. - senzon.za Washington, D.C.; at 4915 St. Elmo In addition to such other information as 4 3630 Schedule A. . Avenue. Bethesda. Md.: or at German- may be required, the fonowing informa- g town. Md. tion shall be included in the Shipper's _- Attraoarrr: The provistor3 of this Part 36 inc I e ses for Export Declaration: Identification of the , Issued under sec.181,68 Stat. Ges; 42 UE.C. g 36.12 Ise nee f ' expo yP byproduct material; the quantity in 2201. Interpres or apply secs. st, s2. ts2,183 - curies; and the ratio of tritium to the es stat. 935, 953, 954; 42 U.S.C. 27.1, 2112, The C-minton may, upon applica- - 2232, 2233. tion by an . interested person, issue a . total quantity of hydrogenif the material a tr'1 Mum-activated luminous paint. I 36.1. Purpose and scope. Iicense authorizing the export of by-product material to a country or desti- 9 36.23 Export of americium 241. This part prescribes regulations gov- nation listed in i 36.50, Schedule A, for "i trning specific licenses for the export of the export of byproduct material in ORO-BMG A general license designated AEC-byproduct material and establishes cer- quantities or forms not authorized for is hereby issued authorizing - tain general licenses for the export from export under general license if, in the any person to export americium 241 from j cond import into the United States of opinion of the Cnmminion, the proposed the United States to any foreign country ] byproduct material. The provisions and export would not be inimical to the com- except Poland or Rumania or countries or requirements of this part are in addition mon defense and security. destinations usted in t 1830, Schedule A. g
.. to, and not in substitution for, other re-OmaAr. mmas ScutnULrs ;
quirements of this chapter. In par-ticular, the provisions of Part 30 of this B 36.21 Export of certain byproduct 6 36.50 Schedule A. ] chapter apply to applications and 11- material to countrice other thss
-(a) Alhanta (
censes subject to this part. Schedule A countries. (b) Bulgaria. " Any ucensee inay expon byproduct (c) China, including Manchuria (and -4
$ 36.2 commonleations. material covered by his Ucense to any excluding Taiwan (Formosa)) (includes 3 (a) All enmmunications and reports muntry or destination not listed in Inner Mongolla; the provinces of E concerning the regulations in this part i 38.50, Schedule A: Protdded, 'Ihat the ~ Tsinghai and Rikang; Rtnktang; Tibet; ;
with regard to export should be ad- authority conferred by this section shall the former Kwantung Leased Territory, i dress?d to the Director, Division of State apply only to byproduct material having the present Port Arthur Naval Base Area , g and Licensee Relations, UB. Atomic an atomic number from 3 to 83, inclu- and Liaoning Province). b Energy CnmmMinn Washington, D.C., sire, and to tritium when contained in (d) Communist-controlled area of Viet . 20545. . luminnus safety devices installed in air. Nam.- m (b) All communications and reports craft and distributed as generally (e) Cuba. - - E Esr-uing the regulations in this part licensed items pursuant to i 31.7 of this (f) Czechoslovakia, with regard to import should be ad- chapter. (D East Germany (Soviet Zone of _ dressed to the Director, Division of Ma- Germany aM the Soviet Sector of Ber- _j
$ 36.22 Export of certain quantities of terials Y3e-fn% US.-- Atomic Energy tritium and poloniam 210. UA)- 9 ra~~nmmisminn Washington, D.C, 20545. (h) watnn1m =
(c) Communications and reports may (a) A general limnae is hereby issued (1) Hungary. E be delivered in person at the Cnmmix authorizing any person to export from (j) Istria. . _ ston's ofBees at 1717 H 8treet NW Wash- the United States to any foreign ce (k) Lithuania. ington, Dr.; at 4915 St. K1mn Avenue, try except Poland or Rnmania or coun- (1) North Korea. 3 Bethesda, Md.; or at Germantown, Md. tries or destinations listed in i 36.50, (m) Outer Mongolia E
'8 Schedule A,5,000 curies of tritium and (n) Union of Soviet Socialist Re-3 36.3 Ueesnee requirements for export 5,000 curies of polonium 210 in a calendar pAblics, ~- k-of byproduct masteriaL quarter. Not more than 1,000 curies of -
tritium may be exported by any person , Caces itsunzwcz Tanz.s - g (a) No person ahan export byproduct to any one country or destinatkm in a , y,,,,ceso, oza seetton , material from the. United States except calendar quarter and not more than 100 33.1 _ - -- New
- as authorised pursuant to the regula- curies of tritium may be exponed by asi --- - - N** u tions in this part and Part 30. any person in a single shipment under ses _ - 8023 (a) and (h) g (B) No persocr ahan export byproduct this general Ecense . Exports under this so.11 - ----e ...? - New :
material from the United States know. general license may be in one or more 36.12. - so23(e) j ing or having reason to believe that it of the following forms or products only: asal ~ 8023 (d) (f) I la to be reexported directly or indirectly, (1) Tritium activated luminmis paint;
~ ~~
-sess(g) l in whole or in part, from the country of ultimate destination shown on the export pounds.
(2) Tritium - labeled ~ organic com-
@ 7--
3620 S ~-- ~ 2 - 30.75 9 E license, shipper's export declaration, bill (3) Trittated accelerator targets; {PA Doc. 65-6sS4, Filed, June 25. 1965; g
. Cf lading, or ecmmercial invoice, unless (4) Polonium 210 static eliminators; 18:14 " "'I a either: '
(5) Polonium 210 neutmn sources; = (1) The reexport has been authorized (8) Trithan or polonium 210 calibra- ' Export ahlpmenta of bellum gas are sub. gl by the r'nmmimminn; or tiota standards' ' '
' 3* * ** Sh* 18'*"8188 ""thC87 ""d "8"3*' , d
-(2) At 'the time' of export' the ma-terial may be exported directly from th-)
(7) Tmminennent light sources; (8) Tritium sources for chromatog* [ ****/ miamirm for trittum contained in hanum 3 b the I United States to the new country of ulti- raphy instruments; does not re11en any person from comp! ring i mate destination under the terms of one (9) Electron tunes; or - with the ucensing requirements and regula-
+
cf the generallicenses estahnahed in this (10) Tritium as a mantaminant of he- - tions of the Department or state appucable 2 part. . . - -lium 3 in a concentrat8on not to exceed to the esport of henum s. , ,,
' . 1-s A e a
-_.4 mw g e
=
- d
OFFECHAL USE ONLY j OFFICIAL USE ONLY AEC-R 30/69 October 5, 1966 COPY NO. ~P I
~':, cm ATOMIC ENERGY COMMISSION g; PROPOSED AMENDMENT TO 10 CFR 35 HUMAN USES OF BYPRODUCT MATERIAL '
k Note by the Secretary The Director of Regulation has requested that the attached report by the Director, Division of Materials Licensing, be circulated for consideration by the Commission at an early date. W. B. McCool Secretary
, T;' r s2
- l l
{ DISTRIBUTION COPY NO. DISTRIBUTION COPY NO. l Secretary 1,74-83 Compliance 31 - 36 l Commissioners 2-6,84-89 Congr. Relations 37 - 38 l General Manager 7-8 Contracts 39 - 41 ) Deputy Gen. Mgr. 9 Ind. Participation 42 l Dir, of Regulation 10 - 12 Inspection 43
*^
Deputy Dir. of Regulation 13 International Affairs 44 - 46 Asst Gen. Mgr. 14 Isotopes Development 47 Exec. Asst, to GM Q, 15 Materials Licensing 48 - 49 Asst. GM for Admin. 16 Military Application 50 Asst. GM for IA 1 Naval Reactors 51 - 52 Asst. GM for Operations 1 Operational Safety 53 - 54 Asst. GM for Plans & Prod. 19 Operations Analysis 55 Asst GM for Reactors 20 Plans & Reports 56 - 57 Asst. GM for R&D 21 Public Information 58 - 59 Asst, to GM 22 Reactor Dev. & Tech. 60 - 69 General Counsel 23 - 29 Reactor Licensing 70 - 71 l Biology and Medicine 30 Safety Standards 72 - 73
^
x - c g\; 'OFFECHAL USE ONLY - s_
w - Nummumuuuuu uuuul I OFFECHAL USE ONLY ' OFFICIAL USE ONLY AIDMIC ENER0Y COMMISSION FB0 POSED AMENEMENT 7D 10 CFTt 35 HUMAN USES OF BnH010CT MATERIAL: LICENSES FDR GROUPS OF DIAONOSTIC USES OF BYPPODUCT MATERIAL IN HUMAN 3 Report to the Director of Beculation by the Director, Division of Materials Licensing THE PROBLDI
- 1. To consider publication for public comment of proposed amendments to 10 C E Part 35, " Human Uses of Byproduct Material", which would identify two groups of diagnostic uses of byp mduct material in humans and specify that an application for a license for a diagnostic use or uses within either or both of the groups may be considered by the Commission as an application for a license for all of the uses within the group 6)if the applicant is qualified.
BACKGROUND AND SLM!ARY 2 Un w the regulations in 10 CFR Part 30 it has been the general practice of the Commission to issue licenses only for the uses, quantities, and types of byproduct material requested by the applicant even though he may be qualified for a license of greater latitude. Occasionally, a related authorization which the
, applicant has failed to request is included in a license if it appears necessary or expeditious for the operation of his program and is within his demonstrated qualifications, but the license is usually designed to reflect the requested pro-gram as closely as possible.
/
3 Most diegnostic uses of byproduct material can be divided into two groups based on similarity of requirements for pLysician training and experience, facil-ities and equipment, and radiation safety. Group I includes the diagnostic uses characterized as uptake, dilution, and excretion studies. Group II consists j entirely of scanning and tumor localization procedures.
- 4. The requirements for a license to perform a given diagnostic procedure are sufficient 1y'aimilar to the requirements for performing the other diagnostic procedures within its group that an applicant requesting one or two uses is often q2alified to be licensed for all of the uses in the group. Under the present 2
OFFHCHAL USE ONLY
OFFICIAL USE ONLY
- 5. FFHCHAL USE ONLY licensing system, however, he is licensed only for the apecific uses which he has requested. D e proposed amene + a vr.ul .1 ,e
'vo groups of diagncstic uses and specify that the Comic::!t - will come m tion for a diagnostic use listed in a group as an applicction for all cf I on within the group if the applicant is qualiffed.
5 'Ihe diagnostic procedures included in esch group would be listed in a schedule in a nev 935.100, 10 CFR Part 35. The proposed cchedule would include only those diagnostic uses for which the clinical procedures are well-established. As the staff, with the assistance of the Advisory Committee on Medical Uses of Isotopes, defines criteria for licensing other diagnostic uses of radioisotopes with well-established procedures, 835 100 could be amended by the Director of RegulationunderhisauthorityinBl.25(a)(2),10CFRPart1,to"... issue amendments and proposed amendments of regulations which he finds are corrective amendments or amendments of a minor or nonpolicy nature that do not substantially modify existina *egulations . . ." l
- 6. An applicant requesting a licence for a specific diagnostic use within l one of the groups is often, but not always, qualified for the entire group. If he is not, he vill be issued a license only for the specifically requested uses i
for which he is qualified. % be issued a license authorizing.an entire group of i uses,theapplicantmust(a)satisfythepresentmedicallicensingrequirements) of 935.11 or 53512, (b) have adequate clinical training and experience in the ! types of uses within the group, and (c) have appropriate radiation detection instru=entation for the uses within the group.
- 7. The uses in each group are described in terms of the radioisotope, chemical compound, and specific diagnostic technique or organ to be studied.
( Possession limits in the license vill be based on those requested by the applicant l and, for those uses not specifically requested, they will be based on limits which the staff has found thmugh experience to reasonably meet the needs of physicians. l l 8 The proposed amendments can greatly simplify the licensing process both ~ for the Commission and for applicants. The Commission's experience under its l OFFHCHAL USE ONLY
OFFHCHAL USE ONLY OFFICIAL USE ONLY rogulatory progran has shown that applicants applying for medical byproduct material licenses frequently limit their requests to their immediate require: tents ehich may not meet their needs during the normal progress and conduct of their programs. This results in the need to submit additional applications for license amendments which may not require additional health and safety evaluations by the Commission, but do involve the paper work necessary to process a license amendment. It is expected that the medical licensing pmcedure to be authorized by the proposed l amendments would eliminate the need for hundreds of medical license amendmente l l vithin the next year alone. l l l
- 9. The members of the Advisory Committee on Medical Uses of Isotopes were invited to comment on the proposed amendments. Two members responded, both favorably.
Cae comment raised technical questions which had previously been decided by the Committee and were therefore beycad the scope of this paper.
- 10. It should be emphasized that the proposed amendments would not relax the gafety standards in the regulations for the protection of public health and safety, but are aimed only at the liberalization of licensin6 procedures. It is a step in implementing a program being developed by the regulatory staff to revise the Commissionb systen of materials licensing and regulation to achieve the requisite safety goals without unduly res'tricting licensees.
STAFF JUDGMENTS 11 The Office of the General Counsel and the Divisions of Safety Standards, State and Licensee Relations, and Compliance concur in the recommendation of this p2per. - The Office of Congressional Relations concurs in the draft letter to the Joint Committee on Atomic Energy. The Division of Public Information prepared the draft public announceaant attached as Appendix "C". RECOlEENDATION
- 12. The Director of Regulation recommends that the Atomic Energy Commission:
- a. attrove tne publication of the proposed amendments to 10 CFR rart 35 contained in Appendix "A", allowing sixty days for public comment;
-k.
OFFHCHAL USE ONLY
OFFHCHAL USE ONLY OFFICIAL USE ONLY
- b. Note that the Director of Regulation may e=end proposed i 35.lOF, TO CFR Part 35, when effective, pursuant to the authority described it: B 1.25(a)(2), 10 CFR Part 1, to include additional diagnostic u.ses of byproduct material in hu=ans;
- c. Note that the Joint Co==ittee on Atomic Energy vill be informed of these actions by letter such as Appendix "B"; and
- d. Note that a public announce=ent such as Appendix "C" vill be issued at the time of publication of the notice of proposed rule -a1 ring.
LIST CF ENCLOSURES APPriDIX PAGE No.
"A" 10 CFR Part 35, Hunas Uses of Byproduct Material -
{ Licenses for Groups of Diagnostic Uses of Byproduct Material in Hu=ans . . . . . . . . . . . ......... 6 "B" Draft Letter to the Joint Co==1ttee on Atomic Energy . . . 10 "C" Draft Public Announcement . AEC Proposes to Si=plify Medical Licensing for Dia6nostic Procedures. . . . . . . . 11 9 3 OFFHCHAL USE ONLY
APPENDIX "A" A'IOMIC ENERGY CobNISSION (10 C E Part 35) HLHAN USES OF BYPROIUCT MAERIAL Licenses for Grotme of Diarnostic Uces of Dynroduct Material in Humana It has been the general practice of the Atomic Energy Commission to issue medical licenses only for the clinical uses of byproduct material in humans which are specifically requestad by the applicant. A proposed amendment to Part 35, 03514 set forth belov, would divide diagnostic uses of radioisotopes into two groups and specify that an application for a diagnostic use within a group vill be considered by the Commission as an application for all of the uses within the group if the applicant satisfies the licensing criteria for the group. The diagnostic uses of byproduct material are grouped on the basis of similar requirements for physician training and experience, facilities and equipment, and radiation safety. Group I includes diagnostic uses characterized as uptake, dilu-tion, and excretion studies. Group II consists entirely of scanning and tumor localization studies. Its diagnostic procedures included in each group would be listed in a new t l 835.100, 10 CE Part 35 The proposed schedule vould include only those diagnostic l uses for which the clinical procedures are vell-established. i L l The licensing criteria which an applicant vould have to satisfy in order to have his application considered as a request for an entire group supplement the present medical licensing requirements in a835.11 and 3512, lo'Cm Part 35. For Group I uses, the Commission would consider the physician's clinical experience in the performance of uptake, dilution, and excretion studies involving the use of radioisotopes in humans and the availability of appropriate radiation detection instrumentation for each type of use. To qualify for a license for the diagnostic uses in Group II, the physician vould have to demonstrate adequate clinical expe-rience in scanning procedures and the availability of appropriate scanning equipment. v Appendix "A"
'Ihe . Commission's experience has shown that persons applying for medical licenses frequently limit their requests to uses of particular isotopes which may not meet their requirements during the no'rmal progress and conduct of their programs. 'lhis results in the submittal of additional applications for license amendments which involve no significantly different hazard considerations. It is expected that the proposed amendments of Pnrt 35, without relaxing safety requirements, will expedite the regulatory process and eliminate unnecessary and time-consuming burdens both for licensees and the Comission.
Pursuant to the Atncic Energy Act of 1954, as amended, and the Administrative Procedure Act of 1946, as amended, notice is hereby given that adoption of the following amendment to 10 CFR Part 35 is contemplated. All interested persons who desire to submit written comments or suggestions for consideration in connection ( vith the proposed amendment should send them to the Secretary, United States Atomic
, Energy Comission, Washington, D. C., 20545, within 60 days after publication of this notice in the FEDERAL REGIFIER. Comments received after that period vill be considered if it is practicable to do so, but assurance of consideration cannot be given except as to com=ents filed within the period specified.
- 1. A nev 835.14 is added to 10 Cnl Part 35 to read as follows:'
835 14 Specifie licenses for certain diagnestic uses of byproduct material in humans. (a) An application for a specific license pursuant to 835.11 or 835.12 for a diagnostic use of byproduct material specified in Group I or Group II of 835.100 vill be considered by the Commission as an application for all of the diaancstic uses within the group which includes the use specified in the application, provided: l (1) The applicant satisfies the requirements of 535.11 or 835.12; (2) The applicant or the physicien designated in the application as the individual user has adequate
' Underlined text indicates new material.
7 Appendix "A"
clinical experience in the performance of disenostic 1..ocedures specified in the appropriate Froup in 935.100; and (3) The applicent's proposed radiation detection instmmentation is adequate for conducting the diarnestic procedures specified in the appropriate group in E35.100. l 2. A nev 935 100 is added to lo cFR Part 35 to read as follows: l 835.100 Schedule A - Groups of diagnostic uses of byprcduct material in humans. (a) Group I - Uptake, dilution, and excretion studies (does not include scans or tumor localizations). 1 (1) Iodine 131 or Iodine 125 as sodium iodide for thyroid function studies. (2) Iodine 131 or Iodine 125 as f odinated human serum albumin (IESA) for deteminations of blood and blood plasma volume. (3) Iodine 131 or Iodine 125 es labeled rose benrel for liver function studies. (4) Iodine 131 or Iodice 125 as labeled fats or fatty acids for fat absorption studies. (5) Iodine 131 or Iodine 125 as labeled todopyracet, sodium iodchippurate, sodium distrizoate, diatrizoate methylglucamine, sodium diprotrizoate, or sodium acetrizoate for kidney function studies. (b) Chromium 51 as 1sbeled human serum albumin for castrointestinal protein loss studies. (T) Chromium 51 as sodium chromate for determination or red blood cell volumes and studies of red blood cell survival time. Appendix "A"
(8) Iron 59 as chloride or citrate for iron tumover studies. ( (9) cobalt 58 or cobalt 60 as labeled cyanocobalamin (vitamin B-12) for intestinal absorption studies. (b) Group II - Scans and tumor localizations. (1) Iodine 131 as sodium iodide for thyroid scans. (2) Iodine 131 as iodinated human serum albumin (IHSA) for brain tumor localizations and cardiac scans. (3) Iodine 131 as eacroaggregated iodinated human serum albumin for lung scans. 1 (4) Iodine 131ascolloidal(microageregated)iodinatedhuman serum albumin for liver scans. (5) Iodine 131 as labeled rose bengal for liver scans. P (6) Iodine 131 as todopyracet, sodium iodohippurate, sodium diatrizoate, diatrizoate methyle.lucamine, sodium diprotrizoate, or sodium acetrizoate for kidney scans. (7) Iodine 131 as sodium iodipamide for cardiac scans. (8) Chromium 51 as sodium chromate for spleen scans. (9) Gold 198 in colloidal form for liver scans. (10) Mercury 197 as chlormerodrin for kidney and brain scans. (11) Strontium 85 as nitrate or chloride for bone scans in ratients with diagnosed cancer. (12) Technetium 99m as pertechnetate for brain scans. (Sec. 81, 68 Stat. 935; 42 U.S.C. 2111; see.161, 68 Stat. 948; 42 U.S.C. c201) FOR TIIE ATOMIC E?ERGY COMMISSION W. B. McCool Secretary Dated at Washington, D. C., b this day cf , 1966. , ,
APPFNDIY "n" DRAFT IETTER TO THE JOINT C0fMII'I'EB ON ATOMIC ENERGY
- 1. Enclosed for the information of the Joint Committee on Atomic Energy is a notice of proposed rule making to amend the Commission's regulation, " Human Uses of Byproduct Material," 10 CFR Part 35
- 2. The proposed amendment of 10 CFR Part 35 divides the diagnostic uses of l l
byproduct material into two categories. It specifies that an application for one or more of those medical uses will be considered by the Commission as an application ' for all of the uses within a category if the applicant is qualified. The amendment includes only diagnostic uses of byproduct material with well-established clinical procedures as determined by the Commission with the assistance o,r the Advisory Committee on Medical Uses of Isotopes.
- 3. It has been the practice of the Commission to issue medical licenses only for the clinical uses specifically requested by the applicant even though he may be qualified for a license of greater latitude. This results in the submittal of additional applications for license amendments which involve no significantly dif-ferent hazard considerations. It is expected that the proposed amendments to Part 35, without relaxing safety standards or qualification requirements of physicians, will expedite the regulatory process and eliminate the need for hundreds of medical license amendments within the next year alone.
- 4. The notice of proposed rule making vill be filed with the office of the Ibderal Register and vill allow sixty days for public coment from the date of publication in the Federal Register.
- 5. Enclosed also is an announcement which we plan to issue on this matter in a few days.
m Appendix "B"
APPENDIX "C" DRAFT PUBLIC ANNOUNCHENT AEC PROPOSES TO SIMPLIFY MEDICAL LICENSING FOR DIAGNOSTIC FROCEDURES he Atomic Energy Commission is proposing to amend its regulations for licensing the medical use of radioisotopes in diagnostic procedures. The change would greatly simplify the licensing procedure both for applicants and for the Commission by granting licenses for more than one related diagnostic procedure, even if only one is applied for, if the Commission finds the applicant qualified. It has been the general practice of the AEC to limit radioisotope licenses to the specific uses, quantities and types of material requested by the applicant, even though the applicant appears qualified for a license of greater latitude. l This often results in the need to submit further applications for additional authorization as the licensee's work progresses. l i l The p mposed amendment would divide the most common diagnostic uses of radio-isotopes into two groups and' would specify that an application for a use of a l radioisotope within one of the groups may be considered by the Commission as an application for all of the uses within the group if the applicant satisfies the licensing criteria for the group. To be considered for a license authorizing an entire group of uses the applicant must satisfy present AEC medical licensing requirements, and must have adequate l clinical training and experience as well as appropriate radiation detection l I instruments for the uses within the group. One group includes the use of radioisotopes for medical uptske, dilution and excretion studies. Included in this group are tests cf thyroid, liver and kidney functions; fat absorption studies; and deteminations of the volumes of certain body substances such as blood. The.other group includes scanning procedures and tests for localizing tumors. The amendment vould simplify the licensing procedure but would in no way relax the Comission's safety requirements. The Commission believes that the new procedure would eliminate the need for hundreds of medical licenie amendments in the first year alone. Appendix "C"
The Commission is giving notice that it proposes to adopt this pmposed-emendment to Part 35 of its ' regulations. Persons wishing to submit comments or suggestions concerning the proposed rule should send them to the Secretary, U. S. Atomic Energy Commission, Washington, D. C., 20545, within sixty days ofter publication of notice in the Federal Register on . 1 P I i i l l 12 Appendix "C"
Published 32 FR, 14265, October 14, 1967 142G I Rules cmd 3eguhtions
- 1. A new i 35.14 is r:dded to 10 CFR (2) Iodine 131 as todinated human h*tle 10-ATOLIIC ENERGVi rart 35 to read as fenews: serum aibumin (inSA> for brain tumor I cahzati ns and cardae scans.
Chapter I-Atomic Energy 6 35.14 Specific licemen for certain (3) Iodine 131 as macroaggregated io-Commission diagno tic uscs of isyproduct material dinated human serum albumin for lung in hum n>. PART -HUMAN USES OF '" (a) An appucation for a specific (4) I dine 131 as colloidal (micro-BY DUCT MATERIAL license pursuant to i 35.11 or 135.12 for aggregated) todinated human serum Licenses for Groups of Diagnostic Uses any diagnostic use of byproduct material albumin for liver scans. specified in Group I or Group II of (5) Iodine 131 as labeled rose bengal On November 5,1966, the Commission i 35.100 will be approved for all of the pubushed in the FEDERAL REctsTEa (31 diagnostic uses within the group which for liver scans. F.R.14317) proposed amendments of 10 includes the use specined in the appli- (6) Iodine 131 as todopyracet, sodium CFR Part 35," Human Uses of Byproduct cation if: . iodohippurate, sodium diatrizoate, di-Material". A new i 35.100 defined two (1) The applicant satisnes the require- atrizonte methylglucamine, sodium di-
, i groups of diagnostic uses of radioiso- ments of i 35.11 or i 35.12; protrizoate, or sodium acetrizoate for topes with well-established clinical pro- (2) T% nonlicant or tM physician kidney scans.
cedures and a new i 35.14 set forth the designated in the appucation as the in- (7) Iodine 131 as sodium lodipamide licensing requirements for each group dividual user has adequate clinical ex- for cardiac scans. and specified that an application for a perience in the performance of diagnos- (8) Chromium 51 as sodium chromate license for any diagnostic use within a tic procedures specifled in the appropri- for spleen scans. group would be considered by the Com- ate group in i 35.100; and (9) Gold 198 in colloidal form for hver ' (3) The applicant's proposed radiation scans. mission uses within as an the application group if thefor applicant all of the . detection instrumentation is adequate (10) Mercury 197 as chlormerodrin for satisfied the licensing requirements for .for conducting the diagnostic procedures kidney and brain scans. the group. (11) Mercury 203 as chlormeroRin for All interested persons were invited to i 35.100. specified in the appropriate group in~ brain scans. submit written comments and sugges* 2. A new i 35.100 is added to 10 CFR (12) Strontium 85 as nitrate or chlo-tions for consideration in regard to the Part 35 to read as follows: ride for bone scans in patients with diag-proposed amendments within 60 days 1 d A rm p diag nosed cancer. after publication in the FEDERAL rec- 6 35.100 , (13) Technetium 99m as pertechne. IsTER. tale for brain scr.ns. The commments received in response hmans
*8 to the proposed amendmer.ts suggested (a) Group I. Uptake, dilution, and ex- $'3gt$.8[2 . rfo that additional diagnostic uses of by- cretion studies (does not include scans product material be included. Upon con- or tumor localizations). Dated at Germantown, Md., this 6th sideration of the comments and other (1) Iodine 131 or lodine 125 as sodium day of October 1967.
factors involved, the Commission has lodide for thyroid functi,on studies. For the Atomic Energy Commission. concluded that the proposed amend- (2) Iodine 131 or todme 125 as lodi-ments, with the addition of four well- nated human scrum albumin (DISA) for W. B. McCooL. established diagnostic uses of byproduct determinations of blood and blood secretary. material to the schedule in I 35.100. plasma volume. [ P.R. Doc. 67-12201; Filed. Oct. 13. 1967; should be published as an effective rule. (3) Iodine 131 or iodine 125 as labeled 8:49 mm.) The text of the new I 35.100, set out be- rose bengal for liver function studies. Iow is identical to the text of the proposed (4) Iodine 131 or lodine 125 as labeled l i 35.100 published on November 5,1966, fats or fatty acids for fat absorption gj except for the addition of iron 50 as sul- studies. gM] g g A h / fate for iron turnover studies, iodine 131 (5) Iodine 131 or iodine 125 as labeled Chapt r V-Federal Home Lo n Bank as sodium lothalamate for kidney func- todopyracet, sodium todohippurate, so- Board tion studies, and potassium 42 as chloride dium diatrizoate, diatrizoate methyl-for potassium space determinations to glucamine, sodium diprotrizoate, sodium $UBCHAP R D-FEDERAL $AVING AND LOAN Group I and the addition of mercury 203 acetrizonte, or sodium lothalamate for '$URANCE CORPORAT N as chlormerodrin for brain scans to kidney function studies. [No. 20.917] Group II. It should be noted that mer- (6) Chromiura 51 as labeled human PAR 563-OPER IONS cury 203 for kidney scans has not been serum albumin for gastrointestinal pro-included in Group II. tein loss studies. Required A ounts on Maintenance The text of the new I 35.14 has been (7) Chromium 51 as sodium chromate of Feder I Insura e Reserve slightly rephrased to t:larify that an ap- for determination of red blood cell vol- 08ER 9,1967. plication for any one or more uses in a umes and studies of red blood cell sur- , . group will be approved for all of the uses vival time. s Resolved that he deral IIome Loan in the group if the licensing require- (8) Iron 59 as chloride, citrate, or Bank Board, upc basis of consider-ments for the group have been satisfied. ' sulfate for iron turnover studies. ation by it of the Isability of amend-Pursuant to the Atomic Energy Act (9) Cobalt 58 or cobalt CO as la'aeled ing subparagraph ) of paragraph (b) of 1954, as amended, and the Adminis- cyanocobalamin (vitamin B-12) tot in- of I 563.13 of the iles and regulations trative Procedure Act of 1946, as testinal abs 1T. tion :tufic::. for Insurance ccounta (12 CFR amended, the following amendments of (10) Potassium 42 as chloride for po- 563.13(b)(5)) fo th . urpose of extend-10 CFR Part 35 of the Commtuton's reg- tassium space determinations. ing the presen cha e made by said ulations are published as a document (b) Group II. Scans and tumor locali- subparagraph ) in 'e Federal insur-subject to codification, to be effective r.ations. ance reserve miann credit require-thirty (30) days after publication in the (1) Iodine 131 as sodium iodide for ment for an dditional wo semiannual PzDEa4L RzcIsTza, thyroid scans. periods, her y amends said subpara-FEDERAL RIGilif R, VOL. 32, NO. 2o0--$ATURDAY, OCTOBER 14,196
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At the p.-c r r.t t'me the Comm!" fan's flurntit!cJ for C"Ven ret"e' es c ';-C '.
.rancln1 frora ihe 'to 10. i T)w b' tr[i E-m cmitting rnet ton uendo, not usted rmubdom p:" We in 4 3tA, 10 C9t rhtm 144, coSMt C3, currt@m 1 M, pA.
at' ave or raith;res rf bet em;ttcrs of Part 31, a p revI Ucence for tti e trenrfcc. nhet 310, rdhm'um 100, rArc nt':,.n rl, unknown compccon.. ..____ ... .1 nnd f.ttcuthat f%-wou'd I;c er : 71 t; Morrs: For purr, w es < 11 :0 2n 3 cut irc ba,cci,1t, Ce,0 cec N 1:M!nn,N t qf cet ow tMti ner.Wp,quatt!c3 perncs- t!.neu qunntit*s pent!/ rL ' ' . .d 20106, e.ere the-o e !nroh .t a comunitt vt of byprcdect rT!crmi n3 cct cat 111 "nn', ci n tca?cd c .ulco", but ic7;.r 1:~1 of thetsotciws combtnation in knemn shdt h vna :ts the thalt Mr I UI ICO, &N d; A. That rehMoM v;al the prcrrnt "c; a smNd tou,r;" ;iy de*1r"1 rs fd. IFt m ,r!!!k-! :n IM. Fince that !!"'O n6 n ir.l,Mr of 10. Tvco of th S_a.J. ' t ()
- ows: D3ttrmine, f.:t ecn t.mtore in t'.e da tonal rM "' 'cm. l'av0 bv.'e OV'd- nr d r tien*:C'n f L imvc fct ad rn cnroht"stion. t he r .do Ix veen the qu W tity prunt in the cr mina mand the it rtt ph>, nnd no *c r m .itcsofr D Urrhc m :! ch'0170 'n 5 W 4 rthcne;ecE .rj -'
otlamvim cr.tabli hm 4r o' cpamet-w m retrcc 1 con **I W qu m' t.t' 21 for C U'1 J'* T.i:r '; than th ~~
-hvi rsettrt cor u c wn, te wn or smit of pp.cctracer trn r" r. -*a'.ens ,Ylith rnc'otheret dcv&' riti;c cym'L.emi MM -
ranos for mit tuo;w m M cornm n : twt c i s cu Igm,2, ,'I*, :I may not excmt ' r d c. m ity') . n w., product instrumentr."et. mn .tlat :ma'l have quartf ratncdMc3 t'dir of ty. La redur b r'.. S c.!n n rc r. : t t?. Por purpor.c s or ;;; us, tr Uva Orm n' t'%'.y b r.r a it r~ a-- leh cr r*3tni N fM s c e r ut"*antC ri g er':cd W 9) r They arc i: rl ! N rc N n"!y c1 ten d!n3 t!!!c 1 cf b ' .! 'r! r:,,;;c :
, c ci C', it r.iny ala !rxlt ; o twt more than chh and t he. 'r r ' mrt h ep".cct'w, r..c C:e e rr = s
- 1 ;;ca, n l ., (g -'_s , ,
exytndint I' r.prears that Cr3 of Emdl U"ed b Cdc t.) (M W X .t. L JJ 4 ftCUAt Frcisite, vot. 3 3,140.1554MU29AY, AUGU5T 10, tua
= I'T.GPO.MD CF E l' '. MING 1141*i ea the r:m :::' q =.nt!ty inair_TaraNrMenL; to 10 CI n Prit 33. 2. A ucw i 30.71 1; cd led t > 10 CFR (mmr a
; tin . M ry:: I. ?!:na ' n f;; sch;elt 01, 02, tud U h cwie.np;' :1 MI in- Part. 39 t'> ni.d na f ollme.,:
t:: r um J b? rA :cd b sc- telc:,ted rercru s&o C ' a ta :.ab nit 0 ,. ** I r; ') n'a. to r LI (;;c Co.d :.1 la ja I;- wi.tn c;c.:. crd: or :ar . ' . . ic? N I" ","I" I,' 1& e' N,'si m m. ds ic : ttr t.O : :o v;W1 t':3 i n . 3.r d 10- car:T.rr?tica iT connac'.c.i t Mh 1:m ; ro-c a 'i.:.: in tb 1. A l'" Ir:ncu;!1:3 of Imc d nuc:nb.ab c'.nu'd t: al tFr:a to Ant imony tIta ( M> =I1:")W# _ __ .. ._ _.. los I = U --
- thca 1. C J.. ..I3 rad l lOIICC11%OOn's the bccrCA Ty, ti.8. b103 5 15 ' If COln* A " w"' nyE 125
- n!idoa, V/cahi'$3(aa. RC. M >. A L. An 9 1 A _..____--- ... lu t N.rm? :1 tri .?nents to 16 CO 1:ntirn:
r;t t : ! V e t]d ef.' O .h. tindu C;n. 'at t Drench, t !Lhin sb:ty G0s dcy; 1'r ch'ci, PuWe her Tdms Nd[ M (9 f.[I -- "-"--y h ,h,[Z:,::] g 1j n I, Imh n'at for the lau2nce of 1.Cc20ta d th ;1muce in thc L.x al. an ntt 77 g,u 77g ___ ______, j e, ,
- fr ..a L e:n3 to la .;:ns \;b in lu- H;cnca. Cc:a M3 n ec.ccd cit:r that le riu: .t at i n a 131 ) _ _ _ . . . . . . . . Io 1.ch-', prcr:3, prcCu 0 12 cM?, re- r. chi vill; Le con:!dcad if it is prec- Ivitua H o ( na 141) _ _........ .. 10 pne: c. ilmrt, cr trantr byptcduct thsb'; ta Q to, bat nn. _ .mce of (on- De t'a e m ou 2 N) _ _ _ __ _..... 1 Inc.L.:rl fj (cl.v." 0 21 QtnbaMn to sidewi' .* crmot be gh tit (:.ccpt as to U,rcanine n t ur c2) . .. _ _. ..... Io I rar; (nwt Intr:,unrl ta g 30 13, 10 c:entab fd:d within tN 0c.1:n1 rp ci- j,] l{tQ1];,-g ,,- $
CM'. Jat 02, cr tr'11vapnt 1ccahtlons ci fi:d. Co 3L 3 of cc:nm:nts on the pro- cadmium 11.> (ca 115 ) . . ...... . 100 CD f "ri cO.'r.t f t Lt2.8 T M d IblJ r.D7 b3 ch'nic.i P.l thO ( hi t e n % p *.. U ) _ . . . _ . _ _ . . . . . . 10 PUM hDliD Cn E C IV M Inc', Gm311:7k6SPubhc DDcMnCtl'03.. CD uld m 41 ( ca 17) _ _ _ .. . _ _._ _ . 10 r.in' d licr na or rn r3:c:r. cat E!:.t2 17Pi H mre,t IN., Washin2tN1. D.C. ca r iwa 11 (c n ) _ _ _ .. .. _ _.... . . 1. a )
' er I3M G s,, m.m3 i r. Cf- C'y/
Ma cerlma 141 ( co 141 ) _ . . _ _ _ _ . . . . _ luo hcenz
}17 6.n..l.i ir .,rtanu'r.r mc m b e p"(.a...,.
ms innm.en...OII, .L, A. u,,.d . L,7i e m.d, N* Co14-r i t.m p 3 D. (Ce 143) .....____.. 100 H,n.,M,., -J p ., ' .' , . .,J t o 1*...... ' 1."w"Is fc . ., 0' . 3
. & mwn 14 9_. _ .__ 1 1DnN.cc.Mc'ft) 1.3W, Of c5:1ndt CEdl-r 3 4' d vwt, , 7'b 6j y+8.4(
cesluin 131 (c . 131 ) . . ....__.. 1 CD's cc .tum IM m (ca 13nn) __...__.__ 1010L tha o! prr d 1 uw'er t n2 , by le gcl.ud. a:e L.s Igr.inid penw,3Icn ir <. n-
- 1. A nw f *0.10 b cdded to 10 CFIt co tun 131 ( c s 13 4 ) _ _ ___ ______. ..
C " 133(C315) 10 ttr.2d to r e.a:ntna ate (La ccenn el . P.n L :n) to Iv..I as fulho, + c'atum 13 3 (es nm _ __ .....- .- .-- to . .. tra:M . ; LJ.;can 19eratoria of :: mil G 30.10 Ibetol qcuthi = ccmun 1:ir (c2 137)__...._____. 10 qu: alt;._ : of b:cprcGurt lacbrial in th- W r :ccM r ; prcdJ.'d in 1:na rc 2h3 (c) rnd (d) of this s:ctica, en; pac.on
$ M " " - - - - - -
chromthN('(,c'r' ch .$$2. .".222 ' 3d 1,039 r?.m etaa%uaa. s 'wk;,comb.g. bic.ag2yt_ansLud;, tgtupLs, taq:d c6 ., 13 c.: rant in.m the Icou crm nts for a c.,b.u t m ( ca t Ja o .. .. _ _.... 10 y hich inn,h c a licch:. ,M rl.s,... licea :c et. forth in r cetica 81 of the Act emit sa ( co s<u .. .. . _..__ ... . to It 11 con.e!Jered l'Jably unlikc17 that p,g gma (,g. rcyclatian; in Fa.t ' 3a-31 couait 60, (ca 00 ) . ._ __ _... . ..... 1 the provi. Coa, of the pmper:0 cxe:up- g ; ::::3 esp.cr to the (:u.' -
- thet rch esper 61 (c a c 0 . . . .. _. . .__ _ _ _.
100 t!aa, ny intvi:iual vcccid n&la or L1- rum;. 2 m ._.. gr. rsc:, tu: . t nm .rs, DN ' h 3 G ( W IW -------- 30 rest mwe (M.n a V2;y s mcll,fracti)n of ov.ns, or cr ai , by.vtd Imixi 1 in Q, jQ I
' M----
nay rat rdi.v, ric; nhl I.:. 5 ucJ or i m,3Ju11 er sat dic ; each cf thii doc 3 m iu'n 171 05- Im '.2 T_.T 190 tim,, n::/ ir.a.nc.iLi sted Igr.ve c.:- r :t c:.c;- I th : s.)E 202 U. ntity 5 2t y,moptan 1M 9 2 h s tu tt: 9 3 L) _. too cu!w tiau 1 of c;d.in:1 rr... Lca. go;w 13 ; yy,1 T ncdu: ? L'. 1;uropima Ire 13 yr Oat 15213 yr)._ l' Tin CunimMca h i:2 t. ': '. fal- m) Lrc. ..aviho; - 3 51:cd- 1:unpums 1M o u 15 0 __ _ ..._ _ . 1 in3 th.!! L: 0 'lp!!On fa n;a h. . lad.J Ic- g< reptn;,] icccj,rd or r c: Ulld }.rior INrophun 15., ( 1.u I f>5 ) ... _. _ _ _ . . 10 r.uironicr.! : for the Ic;c:pt, for:M c3 La 4 te)' ta ; the per m! 1.C a ?then t hr e la O' 10 ) _ _ _ _ __ _ _ _ _.1 U a use,t;mi.i ,3 in '* 31 A cf tb U O *C r 13 C3.- 3 I I 3 3 ------- 3* cn,pt f:c n t!'c rn;tlhcmenL f or r her.3*d'"" "* 3 osMma"a( l a va ) """"' 1;; ,, of the r *L cu.r, ownc10.fp, c;t'an.u. Lcnd i (fr.:quEt'.ca
- % oubtu:um IW
'. 'd b/pscu t, camumv m 10 Inatcricl,1:r.d r thc catrJilicm :.;t cut in c2 fi.:Ja in cc'!vn 81 of tla Act end actmenhn1' 71 (ce 713 2.5Z.2 100 the }u c >c-(4 maendr mta, T.Ul stat c".,n- fro:n the rewh tions in Pa:!.: 3J ",1 of ocid 11,a (t u 1:.3 L .____...___. Ic >
stiinte nn unrced;3n-ulc sii; to the co n-th's ch:Mer la the extcat tint su'h rr r- out IDJ Uut I W .____. ...__.. 1( 0 lacu C f; r.rc r ad !.?c tn!',y cn,.1 13 th? :;on ma ss, Itys, tramfe; or oi.w th tntuin l'a ( t i r 11a ) _ _ _ ....... 19 health rN r foty cl'h p*;l110. r>uch y pm&;ct la'iteria'. I Mrnitu.. Ic 3 p a s c s) _. ........ t oi) a t 1.J,) t r:0".J ia c a r( c" ItWrevu 3 (113) ' Pitn (C) T J; tr ti ,a d324 TGt CU!hCr J Iddium IIO:n On 1155) . . __[ 1,000 "i t9 10] t: cat .J ett>. . P{ao w h apc i.e c;.r. cap , th ' p;d12. J, pW: . ...-'. F a P f;P ;ni. Imi um 11.im Un 2 0M __ _ 1a qu;nt% ef Lyprodu.t wrj rial or s ho c .;rrm: 0 of typ:vduct m; ten 1, for i W- Imuum 115.n on 115u0..... __ M 1aanuf t.tt ere, piort 7 or pietice stuli ga ef cc.1.anda! CN1;bM.r :', or tie Indium 11:, O n 115 ) . .._...__..... 10 t a.uitit!;s. for (latu. v cn a 00anar:dal incarporation of tyi.rodu ; m torir.1into Id ne 12 0 12 5 ) ,_ _. __ _ _ __ _ _ .. . i I l'.. . . v WId he st:Sid to tim 00m O- pod :t1 int.nd.d for c s:n:au cial I*H"" 3 N U 10M - -------------
""" I l #----"--------
3
*L e s 1:ew.;;m nn 11s e .tv y utien ,
- C'"' rM~~'c n' I#J I"* 33I II I3II -------*----- I A t & rr. M' o c h~ '. 9; it ' In t t1 A . . b.'.. q u ,
(c ga p7 5 .:1 InJ, IGT Ic. r;" : of M ;m. 13 ? ( 1 131. .__ . ..._. .. 10 top:.cy./ rr, or it.wm ter of bnu o:nt:r, n nr.- W1 M. ibut loa, im pe: L of Iaa m 13 3 (1 1 m . .. .. .. .. .. .. _ 1 ruc k r.cl v;ho intend to distriMc (;uan. g;7 ,;c7 L.,prcCict nr.telb1 in the indi- Im!me 1:11 (1 1 m __... ___ .... 100 titia of ic.produd, metcral to cmept, c, , ;g p g,,3 c ., gca ;;1 :n g 33 ';g Iom ne tu O 13.H ...... ....... 10 1: '1 A t oh b? rcWin d to idJ rn Itp-c rom en to I M """ 19 2 4 3 ' 3 D - ------ -- ~ IU" 30 10 atou viith tha Cen.ia. Moa for n ve~ g.W IA sei.'):, t )mim o hn.vn/10 proJu-t 3 N"' # ""_' IU (We 1:cem at:thorin7 the fra; olt cr !a,. . ,.
.. .m.
, int s.cbe, t.iti h <pc.nh 11.,.... . fiMl t <u.i to la a m,na Iron L,','
3 p U 'y, M, U' 3 en U"o 3 1:nnFh r gf 1,uch t.uantitica. The opphea* 0:;c; rut r.nk r thia red te 1 or (Tiivrk nt gy pt$n in p[r' 0W_'.l.I'.'_'_"."'l loa 1 s .: :,hc.u.d meet the criterh cf [ d,1D Ic'qd;.h of tn 6 M ecim al Utate, (x- n r s. pion wt 0: e m > _ . . . . . _ . _ _. . . 10 , of 10 CI'R Par; 32. 10 Puttmut ta the At.inde 1:nercy Act of ccut in xco:dat ee ui'h a lie a im d 1st:nn Lu'di u:n a m lit1 :odai(Ls1771.. I tc) . ..... .... .. . Ino
* "N# E3',,I"o 'I th'a' '"". D,' "' , "' h ; #h h.' Ma IL .l. c rm.; Ac !, r.nd r.u ma R3 of
'4 ' " " D Of" 523 -- - ---- 30 titM f> cf 1he Unt! C*ntn Cec .1.:'ay 10
. c Om tiiM3 (Mt the IGP:odnet m? brh1 M n. men tg ((u n u ) ........ Lc _ .... . _ _ _ 1 h hmby LMn U:ri r:Ziti',a o!1:12 fel- r..: 1: tr 3 u 0.1 by t'..3 1.cc .;;c to gn
- p. rya 3 a .m, uatr ta a r.:: tion or 7.,7e g. u t o u I m __......__.. 103 s t. r.: 9 12 rLu r ' ( m :_ *m bu t'. u;u...:!s:3 tr,t.::'jona of cn ecu c- percu:f m 0:; 2 m ....__...... 10 t r. n ! c.rtata rt c t y r.ntb :'y on: Incl.t CZlC. *DWt i> 0 fo im ........ 100 rs ,r :t: c u
- c-:
- u; 1s .r.1 rcr w.4 M M."* 3" ULI 3 W - ~~-- 30 1 :te ., to rc. La 05 . <f sl a /. Mn! ' WW"" Il l UhI ID)-------- Il 3 1 s e. ; y ec d It-', a r.:n.a.;.2. 8 I:2: tM e tc ($ th T 2 TT M% I ICCI I'3 (NI I'33- ------------- 30J F;.,:,t.t ET.is; VOL 3.1, ID.12,--E cf.Y, AUf un 10, IM3
- - . . .. . - . . . . . . _ _ _.___..m
. e . PROPOSED RULE MAKING Enufacture, distribution and M Msi Af(crocuries $ 32.18 tran.fcr of caempt i;uantitics of 1.y. Byproduct Material afferocuries 1.000 product materiale re tuirements f.,r B;. prest act .ifatcrial Zinc 00 (Zn 03)............... 10 10 license. mckel 63 gNi c1)................ 100 Zirconium 33 (Zr 03) ............ 10 L.c ca (N1 6n ................ 10 Zirconium 05 (Zr 05) ............ Io An application for a specific !!cente n Neuan Nm (Nb DJm) .......... 10 Zirconium 07 (Zr 07) ............ manufacture, process, produce, packra, L Iw m M i Nb %) .............. to Any byproduct mr.tcrial not listed repackage, import, or transfer quant *.3 above other than atphs emitting .1 Li Num 97 ( Nb 97 ) ....... ........ 10 byproduct materta1............. of byproduct material for commercir.1 Os num 135 (Os 185) ............. 100 An exempt quantity of any radio- distribution to persons exempt pursuant o num 191m (Os 191m) ........ 100 Nors: t' m.um 131 (Os 101) ............ 100 nuellde may be composed of fractional quan. to i 30.13 of this chapter or the equ;valer.t 100 titics cont.dned in one or more packages regulations of an agreement State wm puum ID3 (Os 1931..............amm 103 ( Pd 103) .......... d if:
.22222' or c ntainers. provided the sum of(a)such trac.ti nal qisantiucs does not exceed the q 5b h rus 2 100 tity sph Red tw that radionuchde in 130.71. requirements Spec 1 fled in ! 30.33 of tw (Pt lot)~ '~~~ ~
100 schedule D. For two or more radionuchdes, chapter 1 Provided, hoicercr That the re.
"b..t.num 191:atmum 19Jmloo the exempt quantity i r the c mbinati n is (Pt 193n[~C~.2. (2) and t3) do C
inannum 193 iPt 193) ...... 100 * 'd **j g$,*'
,g (g'"g[, [" 3h quirements of 130.33(a)not apply to an appIlcation for Platmum 197m (Pt lo7m) ........ 100 to transfer byproduct material manube.
Pinmum 107 tPt 197) ............ .1 desired to the quantity specitted in i 30.71, Phnium 210 ( Po 210) ........... 10 Schedule B, for that nuellde.The sum of the tured, processed. Produced, packaged Cr Pvtanium 42 (K 43) ..............* rattoe of all radionuclides shall not exceed repackaged pursuant to a llCense issued P$ S $ 14 Pr 1 . 10 unity. by(b)an agreement State:The byproduct material is not PrometNum 147 (Pm 147) ........ to d. beverage, cas. Promethium to (Pm 140) ........ 100 PART 31-GENERAL LICENSES FOR c ntained in any I nhea:um Iso (ne 180) ............ Zoo BY P R ODU CT MATERIAL CON. metic, drug, or other commodity desigr ed for ingestion or inhalation by, or app 1 nacmum , laa (ne 188) ..... ..... 100 TAINED IN CERTAIN ITEMS cation to, a human being, or incorpo. nhcalum 103m (nh loam) ...... 100 ramnum 105 anh 105) .......... 3. The title of 10 CFR Part 31 is re. rated into any commodity or product a7 nh
~ - --*
)
~ -*
$ vised to read as set forth above.
intended for commercial distribution; loo 4. Section 31.2(b) of 10 CFR Part 31 nuthenium 07 (nu 06'.22.'.2 10 is amended to read as follows: and (c)The appucant submits copics of nuthenium 103 (nu 103) ......... to prototype labels and brochures and theComm nuthenium tc5 (nu 103) ........ 1 63L2 Terms* and conditiona.
- nuthenium 100 (nu 100) ........ to
- brochures.
samanum 131 tsm 151) .......... 100 (b) Persons who transfer, receive, ac. samarium 133 t em 153) .......... 10 g 32.19 Samei conditmns of licen cs. nanctum 4 G (sc 46) ............. loo quire, own, possess, use, or import items
&a nd ium 47 ( Sc 6.............
- 47) .......... ... 10 pursuant to the generallicenses provided Each Heense issued under 132.18 is wandium 48 (se 48 subject to the foHowing conditions:
theEach quantity of byproduct ma. e$ 31 S13$) . 2".'.2.22 1 Io in (1)i 3L3:Shan not effcet an increase in(a) su cr Ic5 ( Ag 105) ............... radioactivity of said items by adding terial set forth in 5 30.71 S :hedule B ci s1ver 110m ( Ag 11om) ........... I cther radioactive material thereto, by this chapter shall be separately and in. m1ver til ( a g 111) ...... ...... .. 100 10 combining byproduct material from two dividually packaged. Not more than 10 so<num 24 ( n 24 ) . . ..... . ....... 10 or more such items, or by altering them such packaged exempt quantitics sha!! S trenuum c5 (Sr 8s ) ............ 1 in any other manner so as to increase be contained in any outer package for 3;ronnum a3 ( Sr 89) ............ " thereby the rate or radiation therefrom; transfer to persons exempt pursuant to 130.18 of this chapter.The outer packa:e (2) Shall not administer externally or 10' 01 r 015 ~.'.'.".'.~.'.~.'.".'.10. s stronuum 02 (3r 02) ............ loo internally, .or direct the administration shan be such that the dose rate at the Sulphur 35 ( S 35 ) ............... 10 of, said items to a human being for any external surface of the package does Tantatum 182 (Ta 182) ........... 10 purpose, including, but not limited to,research not (b) exceed 0.5 millirem per hour.The immediate con Techneuum so (Tc 06) .......... 100 diagnostic, therapeutic, and Technetium 07m (Tc 07m) ....... too Technetium 97 (Tc 07) .......... urposes. quantity or separately packa;;ed frac.tional
~
(3) Shan not add, or direct the addl. shall bear a durabic. legible label which ool .2 T. .'. tion of said items to any food. beverage, 09 ( 10 cosmetic. drug. or other product designed quantity (1) identifics the radioisotope and the Tenunum 125m (Te 125m) ....... to for ingestion or inhalation by or applica. the contents of radioactivity, (2) states that Tenurium 127m (Te 127m) ....... 100 are exempt from AEC or tion to, a human being. Tenurtum 127 (Te 127) ........... 10 ' Agreement State licensing requirements. Tenurium 123m (Te 120m) ....... 100 (4) Shall not include said items in any bears the words "Radioactwc Tenurium 129 (Te 129) .......... 10 device, instrument, apparatus (including and (3) Tenurtum 131m (Te 131m) ....... 10 component parts and accessories there- Material Not for IIuman Use or for Te:1urium 132 (Te 132) ........... Terbium Ico (Tb 100) ............ 100 to to) intended for use in diagnosis, treat. 8 0# Addition
*.~~ to Foods, Beverages. Cosm Thaluum 200 (T1200) ............ loo ment, or prevent!on of disease in human Thal:1um 201 (T1201) ............ 100 beings or animals or otherwisc intended tics Sh' ould Not Be Combined-Introdd Thaluum 202 (T1202) ............ 10 2 acect W mch w any WWn M tion Into Products Manufactured for Commercial Distribution is Prohibited."
Thamum 204 (T1204) ............ to the body of human beings or animals. The label, or an accompanying brochm. Thunum 170 (Tm 170) ........... 10 sha11 also set forth appropriate addb Thulium 171 (Tm 171) ........... 10 $$ 31.4.31.100 tRevokedl tional radiation safety precautions and Tin 113 t Sn 113) ................ 10
- 5. Sections 31.4 and 31.100 of 10 CFIL relating to the handling, usc.
instructions Tin 125 ( sn 125 ) . . ... ............ 10 Tungsten is t (W 181) ............ to Part 31 are revoked. storage, and disposal of the radioacthe Tun;;3 ten 185 (W 185) ............ 100 Tungsten 187 (W 187) ............ 10 material.Not more than 10 quantitics ret (c) Vanadium 48 (V 48) ............. 1. 000 PART 32-SPECIFIC LICENSES OR forth TO in i 30.71 Schedu;c n of this cham xenon 131m < xe 131m) ......... xenon 133 ( xe 133) ............. 100 100 fd ANU F ACTU 22*
.XEu,PTED sND O!STR!3UTE' ter shallGEN.
be scid or transferred in ny (MPORT Xenon 135 ( Xe 135 ) .............. 100 ., nterblum 175 (Yb 175) .......... 10.01 E2 ALLY LICEN02D ITEMS CCNTAIN. unSe transaction. Q 3,..,.4) Samc reconte and nutu. o Y ttrium 90 (Y 90) ............... 10 ING GYPRODUCT MAT 321AL tran.fer repom. Yttrium 91 (r 91).............. Yttrium 02 (Y 92) ................ 100 C. New (132.13, 32.19 and 32.20 are Ech pctson ;.a M u2 !Zb Yttrium o3 (Y 23 ) ..... . ..... ..... 100 added to 10 CFil Part 32 to read as tha;l maintain record.s ideg.iying n 10 z.nc c5 (zn cs) .. .............. 100 fonows: Z.nc c3m (Zn Co m) ............ 10, 1948
\
FED 1 rat RIGl$t1R, VOL 33, NO.156 $Atua3AY, AUGUST l
~
l - P. 1 0POZD RULE IJA!; LNG 11))7 r: '. ' 'rt r, r. .h ; - 2 t;1 Sc n DcJ ed at W:.4hincluu, D C.. thL Mb 0:. an, Hea tiva of cer tain intu .h I
;* ,t ':dd 1: 1.r .0 1 for dS7 0~ July 100 p. s n ><1 f.kr i n ca u ;._ tl.3.. n. t m
, d'l c* t!)h c::r ' r er the l'or th; l.io.al: 1.u. . C raia kn M Ie' p:t - 81 at to:: '
oral i h . rr,u-
- I d UI Ud ddIU l'; D'. J 'a d10iss u:h-(-
. 1 . i .an i t.I t'.' ;fic'ncht %,. L, ..cu . . c ot, te 11 ty
. br: t!n: ! w. nu, emn.
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u na Suo nad I'c
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(?.' a mal Type 3 of ree uit or this nouet or at the luarina F.,n
.. r Con:er.,i of gy.
Pr0:'Wh; Po:,f[w .:n: cal of licoring in . d. s , la w a ithn it any t!mr: t hhin Da:2 6 d r. af ter rach arin; is c1m ..L
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r .-hr U i c e:ive,1 22 1, u: e, whic:a cor.tain tyco o trn c:m:#cl y of the t*.nm of th:s . . i n s inay be nt ev.s-or in ' . c byprc. duct raater;.II for nny di linet campunants - dch .a c comMin d taly and proper for :.dminLtration nnd at or prior to the ti: of W f ornia. ( nf orce:nent. hu. nan r er:pt in creotac . tith tion Lrd which if f iur :y extruth t . ~ ,
" ". ^ ." *
- ts .* " c ( r Uncral license f:~ ud pur- wrr.JJ fall vilhhi c.C i; t
diona of te::bla fi:)M s nr sel mb :n the rules liy the CasunlWe: ruant ta th - ir u at*c,n3 in tha prit nni Pr ; 3. a M 30 or 33 ci thL cb t;r'. " h *de T.ber m .:J . J. Fru W. Sura, l."ied.3..'"i e.m .iti..c aAt tt". "A. th ' tio: ice Sccrcta ry. (rc ' ' . C . 7,'.c.t. C: <2 U.S C. t.11:: cn 101, var pu',5.d ed in the ' i a.i c u. Rrcim n I ve. 08-0C19: 11 . 1,. .dcd' Aug 9' 19U p< M . t -; - U.Gr.101) oa J:n.2 2J,10,', ;. gg q I m'
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.'s ~E' RULES AND REGULATIONS L V I nae '
.f. tu co:. Ider sup;0y and other asailable ir.for:mGon. it is herebr T*+
i hn. IUin ATA tu tP P u"s.nu Lt d'W.J I .I
-t un for :W,r! oram cr, and found that the hmit>.t .n of handin- of d r 2,2ul..Lic er hereinaitcr Chop:ct I-Atorn:c EnerU I interested per-om.artun:ty to such Valencla provided, will crann tend to .;cetuate the dc-r- u.c v COAM'520" I tia a .! vn o at th!2 clared tio Icy of the act recon- . t!ca and rup- @ It is herchy fut er found that it pAoT 3bHUMAN USES OF i
' ~ ' . ..ou dur- is impracticable and cci ;trary to the pub- BYPP.ODUCT MATERJAL
- e +, . .t !, n c re he interest to I;he D 'cMminary notice,
' nu .d:cci tu the D:partment enrace in Dublic ru!c-:;nbnr procedure. Technetium-%m for Thyro d Scens er ! tini wa h(Id : the prc.il- and postponc the cCc tive date of this Not. ice.ia her6 by riven of the amend-n <4 * .uction, is cludii.g its eCec- section until 30 dayr af ter publication ment of the , AWmc hra h *.
.a - . i lent!ccl - -it h ttic afores.dd hereof in the From:. me:ma C U.S C. tion's rc;' ult. tic.n "I;tunan L,v:n of Dy-intc:wnine be- pmM ? M - ' " 20 CFR Pc.rt 35.
a ,. ci th centttec. and 5537 becattre the tim rc. n.. Luch prevaions tween t! c date then r formStk n upon S ec t ior. ";5100 of Part 35 liat: two h, . i, en chuenm.ated vch:ch thii secticn is 'u al h ana aval:- e 6 Ltd oran:cs: st ab!c and thr time WC. th;s ut.nn munt arcuN of cWnoat.c um of byprvduct, e cf-
.1 ore u (Ccetuate the bewmc e'icctive in o der ta cffectuate material wit! well-catatliahed clinical
+.s of the act. to make this the declared policy of the act is insu.r.. procedurcs. Secti:n 35.14 specifies that l '
d - the penod hercin cicah and a rencnab ' timc Is perm!!- the Commis4cn vcill con:! der an appli.
< ~ ' dum
'. . ! c m; m a with this ac- ted, under the circam dances. for prep- cation for a spcc.Gc liccn A for any
- n: . r, m:' ' - c r. c weial prepara- aration for such cCec t' 0 timc; and cood diamostic use 1;stcd in Groua I or Group ta: em p.i r t c: recsnna subject causc exists for mC' ir the prov!Gns II of 5 35.100 ns an app::ct.!. , . fvr n'!
4 .cannn L ' comp;cted on or hereof eficctive as her .inafter set forth. of the uses within the troup i' the appli-b" > tha cDetWe d tic hereof. Such The committee held in 0:len meetin~ cant is quabiled. during the current we( . rdter citing due The use of tcchnetium-93m as per-cs . a ectin wa he:d on April 7, notice thercof, to cor 'ider sup;.ly and technetate for thyroid rean hr.s become J,N Valencia cran:'es a well-cstr.b!Lhed clinica. ProccGure, Q & /m fD Tne espeitive ctuanti- market cQnditions for tin v ' ~.t! oran. r Cnlifcrnh wh!ch permns v.ere affordcd tion:
*rown in Arirona and the need for rer :a Interested Thc amendment set forth below adda to in opportunity to Group II of i 35.100 the & c cf tcclme-anc. M par; ci id Views at this tium.00m as pcrtcchnctate for thyrold rn:: & !.a Jcd du.a althe 16, Mriod April rubmit inform:.ticn c 1970, are mert:na: the recomme ;dation and sup- scana.
- 10. 1.C t!.: rur.h A: portinr infonnation ft : re;;ulati:n da:- Eecatse th:s amendment u:atet solely hen: < - fo::x cariont in; the period it.ec' ed herein were to m;nor pmerdural rnattcrs, the Com-
' R r .c '. . . W.0
< di D.. ri; 2: 2.J J cartons; promptly submitted tc the Departe.;cnt mission hu found that good caucc exists Ofis IY t:i 3: Unl mited movcment. af ter such recet'n:t w, s held: the pro- for ond:ti.m nonce of propated rule U.: , /u c. ed la th 4
- t tion. " handed." vbions of this uction, meluding its ef- mak!ng, and pubuc procedure thereon.
"D.M ric' i ,' "D;.Mc t 2," " District 3." fccthe time. arc idcati al Mth thc afore- as unnecenary Eince the amendment and "c mn ' have the sanic meaning as stod recommendatica ' f the conunittcc. Ic1!cres from restrictions ttnder regula-rnin' such pro- tions currently in c:!cet, it will become when n: . i in said rm c:'ded marketmg and information conc ne has been dis- ciYective without the customary 30 day agreemen; and crda Y!"icn and cficctivc t' seminated amons; han 3crs of such Va- notice.
(see t-Is e Etr.t. R n amended; 7 UE.C. lcncia oranges; it is n -(escary. in order Pursuant to the Atomic Energy Act' cot a to ef'ectuate t!'c declared . policy of the of 1951, as amended, and sections 552 pg.N,f" g.ig,' a*.*. to mal:e this secti'7 oficctive during and 553 of thle 5 of the United States *, Pm N:enotsort, the period herym sprd.ed; and com- Code, the fo!!owing amendmcnt to Title D. ,% D.w.f
- Truff end pliance with tlus secti. n wLi not require 10. Chaptcr I. Code of Federc.1 Reatia-VcyctaM' Dit e". Coftstmter any special pic7tratic a on the part o' tions, Part 35, is pubhshcd tss a docu-ns cuyect acrcto which cannot bc me:lt subject to codification, to be cfrec-cr.-l l'crN!f r - A -Sc. per>0,cted comp. on or before the ci!ective date tive upon publication in the FEDERAf.
g g;, 3 , .4 met Gr.g was held RrcisrEn. g3 j( hereof. S,uch committc1
on Apnl ." 1D70' Paragraph (1,) of 135.100 of 10 CFR ib e Order. (1) The rcipective quan- Part 35 is amended to add technettum
** bM '
tities of Valencia oran :et crown in Ari-Eona and detiens ted ; .rt of Canfornia Dam as I rtcchnetste for thyroid scans PART E -V A L O '. ! A M ANGES which may be handd dur!nc the period as follow. C . m,.,., , l... . A h. . ... nr. AN,D D t SIG. . 34 Ic. Isained throwa * *' "M f* as f.oliAN c .;s: m 19N; I- nwitic u c. of Lyprod'*ct umatersal in DHO TM.I CT CAGE ORNIA are hereby (1) D.ntrR t 1: lagc. c rtens; h u m.m . lin imficr. of 1(ondiing t h > Datnet 2: low . c a Wnt * * * * ' [ E' e 'O . T A ncis (* ra g e. Itenl..iion (!!!i Dat-ict 3: IFe.L A cartur.s. tos G ro:.p If. Scans and tumor cs As need in th;s a ct'on. "handict," 2." "Datrict 3." locahmtions. a r (1) ?.;rsuant to the
- District 1." "Dru pt . . . .
aa amcnded, and anc " cam 6 hae ta :ame meanini a trm s.r ne;nent. (10 Technet.um-S0m as pertechne-6 '~ m .6cl G CFn 1%:; khc r. uscd in . Ian end(d market!"C tr.te for thyroid scr.nn. L .... e LM lo unling cf Valencir. terctment and ordc t r.r.. net, 7 U S C.
. 7 h1 Arir la r.nG dC,12nated (8.n 1-lit. 48 fint 31 a (Sec. IG1. (3 F..nt. H8. 42 U.S C. 2231) c.U. ;! C '.!crnia, o :ecth c u:. der the 601-C m r Dated at Germantown. Md., this 31st e .b:c pM'oion: <1 the Art. cultural Dated. Ap o.u g, 3 9 . day of March 1970.
SM c t.t. A~rcemem Act of 1037. r.s AtrntN E. Enowrit. For the Atomic Energy Commission. arner.l d a US C. C~i r."O,and upcn Deputy D.rntc r. E ruit cr.d the t..:.5 of the rcer amendations and Vc;rfc5fc Dir: lon, Consumer F. T. Ho s ss. tMcrmation submitte:i by the Valencia and 3:arictin; Sctrice. Acting Secrefary. Or.s:mc Admtniztratha Co m mittee, cs. 8, 3 70;. tn!hhc.1 under the s, id amended mar * [PA Doc. "3-4 W,; F;i1 Apr. 8, 1970; (FA Dvo. To-40ci: Fued. Apr. 8:45 a m l ketina ut:recment ent order, and upon ILo7 p al i f tDttAL HCilf tt, VOL 35, h0. 49-THut$ DAY, APRIL 9,1970
( 6126 RULES AND REGULATIONS ' Arrsuntz C--Ccntlaued Th> dInominator in lach of the above reficCts Cons!deration in the crit'da usCd A sterta! Microcurfee ratios was obtained by a altiplying the r.gure to arriVc at the scheduled exempt S.amarium.153 . ..._ ........ 100
' "I
- Quantitics.of a penn!ssib!c concentration N scandium-4 6 ... ...... 10 (Sec.161, 68 Stat. 948; 42 U.S.C. 2201) of carbon.14 in air in insch.ble form.
Scand;um-47 ............ ........ loo Dated at Germantalwn, Md., this 7th The note at the end of proposd 130.71 - Scandium.4 8 ............ ... 10 Schedule D was misicadin:: at that loca. scienium.76 ._ 10 day of April 1970-tion and has been de:cted. Clarincation
~
":~222.; or A omic Energy Commission. that an exempt quantity may be com-v7rSt ..- .
811rer.110m . . ..... . I 1/. B. McCool., posed of fract!onal parts _o! one or more stiver.111 ._ __.......... 100 Secretary, of the exempt quantities in 1 30.71. Sodium.24 . .. ....... .... .. 10 Schedule B. provided that the sum of strontium.as - ............. to @R . Doc. 70 4556; Faed. Apr. 21, 1970; such fractions does not exceed unity, has strontiu m.83 ... =......... 1 8:45 mm.] been incorporated into f 32.1'.J the sec. Strontium ---
........ o.1 -
tion which sets forth conditions of u N 1 ....... .
........ !o EXEMPTION OF SMALL QUANTITIES specine licenses to be issued to commer.
Bulphur.35 .- loo cial supphers of exempt quantitics. _ _ . . . . . . ........ OF BYPRODUCT MATERIAL The proposed exemption from !! censing Tantalum-102 _ -_.... 10 Technettum-D6 ..= ..- 10 On August 10,1968, the Atomic Energy requirements for small quantitics of by-t Tecla.cuum.07m .- . . 100 Commission published in the FrDERA1. product material would not haVC included i l Techr.ctium.07 . _ ___ 100 Rscistra (33 F.R. 11414) proposed the distribution of products containing l Techneuum.09m ... ... ........ 100 amendments to 10 CFR Parts 30,31,32, such material. The ci!cet of rcrokin'; the l Technetium.co ...... .. ........ 10 and 35 of its regulations. The proposed general license, p 31.4 of Part 31, would l Tc tUmll
* * " " * * *~ ~~~~~
[$ amendments to Part 30 wou!d exempt be to limit d:stribution of products now i Tel:urium.127 . 222.I ........ 100 from licensing requirements the receipt, being distributed under that genera! Telluttum.123m ........ ........ 10 possession, use, transfer, ownership, or license to specific licensees or to persons Telturium.129 .... _. ........ 100 acqu'sition of small quantities of by. exempted or generally licensed by other Ten urt um-131m ........ . ........ Io product material. The proposed amend. provisions of AEC regulations, such as Tellu rtum.132 ........... ........ 10 ments to Part 31 would revoke the the general license for certain measur. Terbium.100 . . . . . . . . . . . . ........ Io general license for small quantities of ing, gauging, or controlling detices set Thallium.200 . . .......... ........ 100 byproduct material currently set forth forth in 131.5 of Part 31. In order to Thal sum 20 . . . . . . . . . . . . ........ M 8131.4 and 'll.100, Schedule A. Con. emphasize the distinction between the Thal:1um.204 2.".22'2 ". 7.2'.'. . 10 fonning amendments would also be made exemption for quantitics of byproduct r Thortum (natural)...... ........ so to the title and to i 31.2 of 10 CFR Part material and exemptions for products Thultum.170 -
. ........ 10 31. The proposed amendments to Part 32 containing byproduct material. proposed Thu11um.171 ......... .. ........ 10 would establish (a) criteria for the issu- ! 32.18 of Part 32 has been mndified to l
Tin-113 ................ ...... 10 ance of specific licenses for the manu- indicate more c!carly the types of mate-t Tm .125 . . . . ... . .. . . . . . . ........ 10 facture, processing, production, packag. rial which commercial supphers rnay Tu nraten 181........... ........ 1 ing, repackaging, tmport or commercial distribute as exempt quantitles. In adda-Tun gs ten.187 22222.' 2 '.~.~2.~. 100 distribution of the exempt quantities of tion a new I 30.15(a)(D r has been added i Urantum (natura:)...... .. ..... 60 byproduct material, and (b) certain to Part 30 to provide cxemption from I Ura ntum.233 ........... ......... .01 license conditions for these specific licensing requirements for possession g Uranium.23 4-Uranium-215 . . . .. . .c1 licenses. The proposed amendment to and use of ionizing radiation measuring , Vanadium.48 ...._ _ ........ lo- Part 35 would clarify that the proposed instruments containing internal calibra. Xe non.131 m ........... ....... 1 o00 exempt quantitles of b> product material tion or standarddation sources of by. Xenon.133 100 f are not for use in humans. product material in amounts not exceed-X e non.13 5 . .. ... .. .. ... ........ 100 On the sarne da:c, the Commission ing the pertinent schedule of exempt str .$o....".2222 22 2.* pubhshed (33 P.R. 11413) proposed quantitics. Such sources, when h1 stalled Yttriu m.91 . .... .. . .. . .. ......... Io amendments to 10 CFR Part 20," Stand. inside instruments constitute a smaller Y t t riu m .0 2 . .. .. . .. . . . . . ......... 100 ards for Protection Against Radiation." risk than as separate quantitics. and Y ttriu m-93 . .. ....... . .. ......... 100 to conform the byproduct material por. specific provision for their use under Zine.65 ................ ......... 10 tions of Appendix C,10 CFR Part 20 to exemption is warranted. 2.nc.C3m .............. ......... 100 the quantitics to be exempted in Part 30. In order to avoid causing undue hard-Zinc.69 ................ ....... 1,ooo 'Ihe proposed amendments would also ship to distributors of othcr products Zirc ontum 93 ........... ........ 10
- add americium.241 and change certain which arc presently being transferred as t ontun 9 2. ' ~. ~.~. '.'.2I'.222'.
Other quantitics listed in Appendix C. generally licensed quantitles, the revoca. Any alpha emitting rac .onucinde 10 CFR Part 20. tion of the general license in 131.4 will not I:sted abme cr m'stures of Interested persons were invited to sub. not become e!Iective until G months of ter , alpha emitters of unkr. ,wn com. mit written comments and suggestions publication of this notice of rule mak-
% ponttton ............ .01 *
........ for consideration in conntetton with the ing in the FEDERAL Rrcision. If a peti.
Any radionucinde other t::an alpha proposed amendments within C0 days tion for exemption of such a product itom + emitting ru.ttonucitoes. not insted af ter publication of the notices of pro- specific licensing requirements is alled above or mixtures of reta emit
- poud rule making in the FEDERAL prior to revocation of the ECncralllCenSc.
ters of unknown comp .st tlou . . . .1 RzersTra. After consideration of the the Director of Regulation will consider Nors: For purposes of H 20.203 and 20 304, comments and other f actors involved, the extending the cencral liceme until such where there is involved a :ombination of iso- Commission has adopted the proposed time as the petition for exemptir n is topes in known amount, the limit for the amendments with certain additions and finally determined. The G.menth delay combination should be tertved na follows: modifications dir,custed below. in revocatiot) will also pctmit commer-Determme, for each isotnne in the. combina. The quantity of todine.134 in the pro- cial supplicts now distributing quanti-1 d. com ina $d fhetr t t r1 posed schedule of exempt Quantitles, ties of byproduct material under the scn-estab;tshed for the specirc isotope when not i 30.71, Schedule B, was incorrectly listed eral license, to obtain the required spc-in combination. The sun. of such ration for as 100 microcuries and has been reduced cine licenses or license amendments and a!! the tsotopes in the cambination may not to 10 microcuries. to implement requirements iegarding exceed "1" (i.e.. " unity") . Example: For pur- The proposed exempt quantity of labels and brochurcs. poses of 8 20 304, it a parucular batch con- cart,on.14 in 130.71, Schedule B, has The terms and conditions of 131.26b) taina 20.000 ac of Au* and 60.000 se et cu, been reduced from 1,000 microcuries to applicable to the general licenses for 100 microcuries. The 1,000 microcurie certain devices and equipment (131.3) 1 1 imi na d ined a ofi ' quantity was derived on the basis of and for smr.!! quantities (1 31.4) are 8 limits on concentrations in air for soluble considered to be of such small signifi- / suav Aqsa.noo e cago ,e lath &' y ~~IhM e a ~1@ 6 forms of carbon.14.The reduced quantity cance to the remainin; ;enerally licensed h FEDERAL BECi1 tea, VOt. 35, NO. yS.-WEDNE10M, APtit 22, 1970
- v. -
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RULES AND REGULATIONS 6127 det!ces and equipment that they will bc The Commisalon has found that the for a license set forth in section 81 of resoked concurrently with revocation of exemption from licensing of small quan. the Act and from the regulations in the gcncral hecnse for small quantities, tities of byprodu:t material and of ioniz. Parts 30 34 of this chaptcr to the ex. 1 rnther than modified to remove refer- ing radiation measuring instruments tent that s.uch person possesses, uscs, ences to quantitles as was proposed. containing certain internal c6libration transfers or owns such byproduct Proposed I 32.19(b) has been revised or standardization sources under the material. to permit the presentation of some of the conditions set forth in the fonowing (c) This section does not autho117e the information required in n label on im- amendments will not constitute an un. production. packaging, repackaLing, or ' 'l mediate containers of exempt quantitics reasonable risk to the common defense import of byproduct material for pur. to be presented instead on an accom. and security and to the health and safety poses of commercial distributicn, or panying brochure. In many cases, it is of the public. the incorporation of byproduct material impractical to put all of the wording on Pursuant to the Atomic Energy Act into products intended for ccmmercial the immediate container because of size of 1954, as amended, and sections 552 distribution. er use limitations. Under the revised and 553 of title 5 of the United States (d) No person may, for purposes of I 32.1Dt c), the immediato container of Code, the following amendments to commercial distribution,impo t or trans. - . each quantity, or separately packaged Title 10, Chapter I. Code of Federal Reg. fer byproduct material in the individual fractional quantity, is required, as a ulations, Parts 30,31,32, and 35 are pub- quantitics set forth in 130.71 Schcdule minimum, to bear a durable,Icgibic label lished as a document subject to codifi. B, knowing or having reason to believe identifying the isotope and the quantity cation. The amendments 'to 10 CFR that such quantitics of byproduct ma. of radioactivity, as well as the words Parts 30,32, and 35 shall become effec- terial will be transferred to persons ex.
" Radioactive Material." tive thirty (30) days after publication empt under this section cr equivalent Proposed 132.00 has been revised to in the FEcER AI, RrcIsTtn, and the amend. regulations of an Agreement State, ex-clarify the requirement for an annual ments to 10 CFIL Part 31 shall become cept in accordance with a license issued summary report of the tctal quantity of effective G Inonths after publication in under I 32.TS o! this chapter, which each isotope transferred under a spc- the FEDERAL RzczsTER- license states that the bypr3 duct ma.
terial may be transferred by the licensec cific license Records mustissued pursuantoftoir.dividual be maintained 132.18. PART 30-RULES OF GENERAL APPLI. to persons exempt under this scction or transactions. Indicating the name and CABILITY TO LICENSING OF BY. the equivalent regulations of an Agree. address of the recipient and the kinds PRODUCT MATERIAL ment State. i and quantities of byproduct material 1. In 130.15(a) of 10 CPR Part 30, a 3. A new I 30.71 Schedule B is added i transferred, but such detailed informa- new subparagraph (9) is added to read as to 10 CFR Part 30 to read as follows: tion is not required to be included in the annual report. The revised reporting I'lIO*8 g 30.71 Schedule B. ree.uirement would require the licensec $30.13 Ccriain items containing h 3proJ* syproduct material Af.erocuries to furnish the specified information or uct material. Antimony 122 (sb 122)......... 100 state that no transfers were made dur- (a) I:xcept for persons who apply by. Anumony 124 (sb 124).......... to ing the reporting period. product material to, or persons who in. Anumony 125 (sb 125)........ to The ru!cs set forth below would (a) corporate byproduct material into, the Arse* nic 73 ( As 73 ) ................ 100 Io exempt from licensing small quantities fonowing products, or persons who im. ^^*"k
- 7' f^' N -- -"-~......
" (^* *-"-"-"-"... 10 of byproduct material (b) revoke the port for sale or distribution the follow. ^** """""""- I existing general license for similar quan. ing products containing byproduct ma.
titics of byproduct mattrial. (c) exempt terial, any person is exempt from the t[m14o(n 6"""""~ a ib , requirements for a license set forth in msmuth 210 ( ni 21o) l'.'.'.~.~.~.~.~.~.~. 10I / oduct ni er I con ned section 81 of the Act and from the regu. Bremine e2 ( Dr 82) .............. 10 tion sources instaUed in fordzing radia- lations in Parts 20 and 30-36 of this cadmium 109 ( cd 109) ........... tion measuring instruments, (d) estab. chapter to the extent that such person cadmium 11sm (cd 115m) ...... to lish requirements for issuance of specific receives, possesses, uses, transfers, ex. cadmtum 115 ( cd 115) .......... 100 10 licenses for distribution of exempt quan. owns, or acquires the fonowing C"I#* ca:clum * '547(C" (Ca'8) "."..".."..".. 47). . "..-
. 10 titics of byproduct material, and te) ports' cts. produ 100 clarify wording in Part 'M regarding
. carbor. 14 (c 14)................
* * * * . cerium 141 (ce 141)._ _
100 use of exempt quantitles of byproduct 100 matenal in humans. Pcrtons holding an (9) Ionizhig radiation measuring in. certum tI4' o ( ce 14 4..............
"."'~2'l'"'. 1
'I AEC or an Agreement State byproduct struments containing, for purposes of $3 $ 131 cs . .
material license authorizing manuf ac. intomal cahbration or standardization. cesium 134m ( ca 134m) .......... 100 ture, processing. or production of by. a source of byproduct material not ex. cestum 134 (cs 134)............ I 10 product material are authorizcd under cceding the applicab!c quantity set forth cesium 135 (cs 135) .... .......... 10 the exemption to make transfers, on a in 130.71, Schedule D. cesium 13G (ca 136)............ rioncommercial basis, of exempt quanti. . . cestum 137 (cs 137) .............. to ties of byproduct material possessed 2. A new I 30.18 is added to 10 CFR or$e under the license, on an 'cxcmpt basis. Part 30 to read as follows: chromium 51 (cr 51i........... 1,0co This provision is desir acd to accom. cobalt Lam (co sem) ............. 10 modate the occasional transfers between 6 30.1C Esempi qua ntit.e. cobatt sa (ca 58 ) ................ 10 laboratories of small quantities of by. (a) Except as provided in paragraphs cc,bnit 60 ( co 60 ) ..............'. I product material in tissue sa nples, bio. (c) and (d) of this section, any person copper 64 ( cu c 4 ) . . . . . .. ... . .. . 200 , asray samp!cs, tagged ccmimnds, count. is excmpt from the tcquirements for a DSP"N" IE3 ( D I'03" " " " 30 ing standards, etc., v.nich invohc neg- license set forth in section 81 of the Act ligible risks. A t;oducer, packacer, re* and from the regulations in Parts 30-34 ErbtS 171 (Er 171).
*Yg Yg",I79 3
[ loo packager, or immrter who intcnds to of this chapter to the extent that such Europium 152 9 2 h (Pu 152 0 2 h). Ico 1 distribute, on a crnmercial basis, quan* person receives, possesses, uses, trans. Europtum 1$213 yr (Eu 15213 yr). - titics of byproduct material fer use under fers, owns, or acquires byproduct mate. Eurcptum 154 (Eu 154) .......... . I the excmptions, even if licensed to rial in individual quantitics each of Europium 165 (Eu 165..-.....-.1 ) .......... Ao10 manufacture, process, or produce such which does not exceed the applicable nuonne**la383 & 18) (* ISD * - IU quantities by an Agreement State, would quantity set forth in i 30.71, Schedule D. cadottr U^d*"".tum 159 ( od 169 ). .."..".".. 100 be required to obtain a specific license (b) Any person who possesses byprod. camum 72 (ca 72) ......... to from the Commisslon authoriz!ng the uct material received or acquired prior Germar.tum 71 (Oa 71 ) ........ import or commercial distribution of such e ) -- . . quantitics.To obtain a license, the appil. to October 22, 1970 under the general y ,1,o,8 gg9
' cant must meet the criteria of I 32.18, sicense then provided in i 31.4 of this Haf nium to (lit 1e1) ........- to 10 CFR Part 32. chapter is exempt from the requirements Hotmium sco (No 168) .......... 100 NoteAt steitTEa, Vot. 35, NO. 74-WEDNtlDAY, APtiL 22, 1970 l _ _ _ _ _ _ _ _ _ . - _ . _
h .
> ' 6128
. RULES AND REGULATIONS . Byproduct mtiertal Microcuries Byproduct matertti Ilydrogen 3 (!! 3 ) . .. ........ .... 1,000 Microcuries chaptct: Prorided, however.That the tc. Tellurium 127m (Te 127m)........ 10 quirements of I 30.33(a) (2) and (3) of Indium 113m (In 113m) .......... 100 Tellurlum 127 (Te 127)........... 100 Indium 114 m (In 114m ) .......... - 10 this chapter do not apply to an rpphca. (4 Ind,um 115m (In I!5m) .......... 100 Te!!urlum 129m (Te 120m)....... Tellurium 129 (Te 129) .......... 100 10 tion for a license to transfer byproduct 'b In<!!um 115 (In 115) .............. 10 Tellurium 131m (Te 131m)........ 10 matclial rnanufactured processed Ero. ' lodine 125 (1 125)................ 1 Tellurium 132 (Te 132)........... 10 i duced, packaged, or repa'ckaged pursuant Iodine 126 (I 126 ) ................ 1 Terblum IC0 (Tb 1G0) ........... 10 to a heense issued by an Agr(cment todine 129 ( I 123 ) ............. . .1 Thaluum 200 (T1 200) ........... 100 State; toenne 131 (1 131)........'........ 1 Thallium 201 (T) 231)...- - 100 (b) The byproduct material is not loome 132 (I 132 ) ................ 10 Thautum 202 (T1 202) ........... , 100 contained in any food, bevera;;c, cosmetic. Ioeme 133 ( I 133 ) ................ 1 Thallium 204 (T) 204)........... 10 i , todine 134 (I 134) _ _ _. _.... 10 Thu!!um 170 (Tm 170) ........... -10 drug, or other commodity desilmed for f Indtne 13 5 ( 1 135 ) . . .. . .. ... . ..... 10 Thultum til (Tm 171) ........... 10 ingestion or inhalation by, or app!!catlan Irlatum 192 (Ir 192)..- _.... 10 Tan 113 (Sn 12 3 ) ... ............. 10 to. a human beir'e 1ridium 191 (Ir 194 ) .............. 100 Tan 125 (Sn 125 ) . ............... 10 (c) The byprod'u' ct material is in the l Iron 5 5 ( Fe 55 ) . . . . . .. ....... .. .. . '100 Ttmgsten 181 (W 181) .... 10 ISrm of prccessed chemical cicments, I ron 50 ( Pe 53 ) . . .. . ... .. .. .. . . ... 10 Tungsten 185 ( W 195) ........... 10 ccm;)ounds, or mixturcs, tisrue saraples, Kryp ton 8 5 ( Kr 85 ) .... ........... 100 Tungsten 187 (W 187) ........... 100 Krypton 87 ( Kr 87 ) ............... bioassay Sam,)les, counting standalds, 10 Vanadium 48 ( V 48) ............. 10 plated or encapsulated 50urces, or simi. Lanthanum 140 (Ln 140) ......... 10 Xenon 131m ( Xe 131m) ......... 1,000 Lut etium 177 (Lu 177) ............ 100 Xenon 133 ( Xe 133 ) .............. 100 lar substances. Identined 33 radioactive Atanganese 52 iMn $2) ............ 10 Xenon 135 (Xe 135) ... - 100 and to be useG for its radicactive prop. 11angancsc 54 ( A!n 54 ) ............ 10 Ytter'olum 175 (Yb 175) ......... 100 erties, but is not incorporated into any Manganese 56 (htn 56) ........... 10 Ytt rium 90 ( Y 00) ............... 10 manufactured or assembled commodity, hiercury 197m (11g 197m) ......... 100 Yttn um 91 ( Y 91) ............... ~ 10 product, or dcrice intended for commer. l Mercury 197 (Ifg 197) ............ 100 Ytt rium 92 ( Y 92 ) ........ ....... 100 cial distribution; and i Alercury 203 (lig 203) ............. 10 Yttri um 93 ( Y 93 ) .......i......, 100 Molybden um 99 (Mo 99) .......... 100 (d) The applicant submits copics of Zinc 65 ( Zn 65 ) . ... .. . . .. . .. . ... . 10 prototype labels and brochures and the Neodymium 147 (Nd 147) ........ 100 Zinc c2m (Zn 60 m) ............. 100 Neodym1um 143 ( Nd 149) ......... 100 Zinc 09 (Zn 69 ) ................. 1,000 Commission approves such labels and Nickel 59 (Ni 50 ) ... ....... ....... 100 Zirconium 93 (Zr 93 ) ............. 10 brochures' N1chel C3 ( Ni 63 ) . .... ............ 10 Zirconium 95 (Zr 95) ............. 10 $ 32.19 kme s romlition, of licen*ca. Nick el 65 ( N1 65) ..... ........... 100 Zirconium 97 (Zr 97) ............. 10 Niobf um 03m ( Nb O3m) ........... 10 Any byproduct material not listed Each license issued under I 32.18 is
. . Niobi u m Dr. (Nb 95 ) .............. 10 above other than alpha emitting . subject to the following conditions:
!* Ntoht um 97 ( Nb 97 6.............. byproduct material............. 10 0.1 (a) No more than 10 exempt quanti. I osmtum 185 (ca 185) ............. 10 ties set forth in f 30.71, Schedule B of ( O~nlum 191m (Os 191 m) ......... 100 this chapter shall be sold or transferred osmium 191 (os 191) ............. 100 PART 31-GENERAL LICENSES FOR in any single transaction. For purposes
${Ea$i$n lof[PdNi'"""" 00 BYPRODUCT MATERIAL of this requirement, an individual exempt
' Palladium 109 (Pd 109) ."T.~.'."',. "
. 100 10 4. The title of 10 CFR Part 31 is re- parts of#one ""# ##
or more of the exempt qualn. Phos Plat umhorus 191 (Pt32 191(P 32)f 100 a3 Ct orb above. Platinum 193m (Pt 193?n')~[.~.'[2.~.' 5. Section 31.1 of 10 CFR Part 31 is tities in i 30.71. Schedule D, provided h' ,s Plau num 193 ( Pt 193) ............ 100 100 amended to read as follows; that the sum of such fractions shall not p- Pantinu m 197m i Pt'197m) .......;. 10 exceed unity. ' Platin um 197 (Pt 197 6............ 100 6 31.1 Purpo.cand* cope. (b) Each quantity of byproduct 'rna. Polonium 210 (Po 210) ........... o.1 Tnis part establishes general licenses terial set forth in i 30.71, Schedule B of Potasst u m 4 2 ( K 4 2 ) ............. 10 for the possession and use of byproduct th s chapter shall be separately and indi I Praseodymium 142 (Pr 142)....... 100 material contained in certain items and vidually packat;ed. No more than 10 such Prancodyrr.tum 143 (Pr 143)....... 100 Promethium 14'r (Pm 147)........ 10 a general license for ownership of by. " " **N e n alud in an omr Mage W
#
- hall b*
Promethtum 149 (Pm 149) ........ 10 product material. Part 30 of this chapter nhensum l8G ( ne 186) ............ 100 also contains provisions applicable to transfer to persons exempt pursuant to nhenium 188 (ne 168)........... 100 the subject matter of this part. i 30.18 of this chapter. The outer pack. . Rhodium lo3m (ah lo3m)........ Im ,a 6. Sections 312(b),31.4, and 31.100 of the ace shall be such that the dose rate at Rhodium 205 ( Rh 105) ............ 100 external surface of the package does 10 CFR Part 31 are revoked.- not exceed 0.5 mi!!! rem per hour.
$$ a ((abh*""~~~"""
eh ~ ~ (c) The immediate container of each
. nuthentum p7 (nu s7) 100 quantity or separately packa;;cd frac.
nuthenium Ic3 (nu 105)T.'.5.'.~.~.' to PART 32-SPECIFIC LICENSES TO tional quantity of byproduct material l I nuthenium 105 (nu 105) ......... Io MANUFACTURE, DISTRIBUTE OR shall tsar a durable, legible label which nuthentum tos (nu 100)......... 1 IMPORT EXEMPTED AND GENER. (1) identifies the radioisotope and the , samarium 151 (sm 161 # .......... t samarium 153 (sm 163) .......... 100 ALLY LICENSED ITEMS CONTAIN. quantity of radioactivity. and (2> bears i Scandium 46 ( se 4c) .............. - the words " Radioactive Material"
~
10 ING BYPRODUCT MATERIAL scandium 47 ( Sc 47) .............. 100 (d) In addition to the label:r.g infor. ; i Scandium 4.6 ( Sc 48 ) .............. to 7. New I! 32.18, 32.19 and 32.20 are mation required by paragraph (c) of + i se:entum 75 (se 75) .............. 10 added to 10 CFR Part 32 to read as this section. the label af3xed to the Im. l ' sitkor. 31 ( 81 31 ) . . . . . . . ..... . .. . . 100 follows: mediate container, or an accompanying sin er 105 ( Ag 105) ............... to silver 110m ( Ag 110m) ........... 1 6 32.18 Enu facturc, sli.tribution arpi contents brochure, shall also (1) state that the st h er 111 ( Ag 111 ) ............... 100 tran fer of ese,mps quantitice of Ly. are exempt from AEC or Agree. - Sodlum 24 ( Na 24 ) ............... 10 proeluct materials requirements for g g strontium as (sr 851............. 10 licen c. bear the words ,,Radjoactive Material-strontium e9 (sr 82) ............ 1 - Not for Human Use-Introduction Ir.to s tronuum 90 (sr 9c . ............ o.1 An application for a specific license to Foods, Beverages, Cosmetics, Dru;:s. or stron tium 01 ( sr 91 ) ............. 10 manufacture, process, produce, package, Medicinals, or Into Products Manufac. stronuum 92 ( Sr 92) ............. 10 repackage, import, or transfer quantities tured for Commercial Distribution is Sulphu r 35 (s 35) ................ 100 of byproduct material for commercial Tantalum 182 (Ta 182) ........... 10 distribution to persons exempt pursuant prohibited-Exempt Quantities should Technettum 90 (Tc 96) ........... 10 to i 30.18 of tlus chapter or the equiva. . ot h CmMmd..; and m sd W.h ap.
, Technetium 97m (Tc 97m)....... 100 lent regulations of an Aareement State propriate additional radiation safety pre.
Technetium 97 (Tc 97) ........... 100 rill be approved if
- Technettum pom (Tc 09m)........ 100 cautions and instructions relating to the
' ,g Technetium 93 (Tc 09) ........ . Io (a) The app!! cant satistles the general hand!!ng, use, storage, and disposal of ;.
Telluri,m 135m (Te 125m)........ 10 requirements specified in i 30.33 of this the radioactive material, i ,
+
i MOERAL REGilfER, VOL, SS, NO. 76-WEDhtloAY, ape 4 32,1970 g I
~ ~ ~ ~ ' '
^ .
{, . fh l4l# ::g;u
. RULES AND REIULATIONS /
~ ~
I 32.20 .%c : renrde cml mrtiri;l ' l 3rmnnfer reports. ! Each person licens<d under . I 32.18 shall maintain recordi identifying, by ,
..name and addrera, eac1 person to whom j
- byproduct materialis tiansferred for use 1 under i 30.18 of this chapter or the equivalent regulat!ons >f an Agreement Ctate, and stating the ) inds and quanti-ties of byproduct mat: rial transferred.
An annual summary r ' port stating the total quantity of eac 1 isotope trans-ferred under the specific, license shall
- be filed with the Director, Division of M tterials Licensing. Ud. Atomic Energy C mmission. Washing on. D.C. 20545.
Each report shall covei the year ending June 30, and shall be f;ed within thirty (30) days thereaf ter. If no transfers of byproduct material hav: been made pur-suant to I 32.18 durir g the reporting period, the report shal so indicate. PART 35-HUMAN USES OF BYPRODUCT AlATERIAL
- 8. Section 35.2 of 10 CFR Part 35 is am:nded to read as follows:
/ $ 33.2 Licen.c require nents.
No person subject to the regulations in this chapter shall rc<elve. possess, use, er transfer byproduct rnaterial for any hum:n use except in a:cordance with a specific or general licelise issued pursu. ant to the regulations in ti.:s part and P.2ts 30 and 32 or 33 of this chapter. (Sec. 81. 68 Stat. 03'5; 4i U.S C. 2111; sec.' 161, 68 Stat. 948; 42 U.S ?. 2201) Dated at Germantorn, Md., this 'lth
. day cf April 1970. -
F;r the ' Atomic Encrgy Commission, f
, V'. B. McCoot Secretary.
lF.R. Doc. 70-4557; Fih .d. Apr. 21.1970; S:45 a.m l f!Df tat afGI37ES, VOL. 33, NO. 78- WIDNt50AY, AP88t 27,1970 t o h N y .
.. _ . _ . . - - _ - - _ . - . _ _ - _ - . - _ _ _ _ . - _ _ - - _ _ - - _ - - - - - - - - - - - - - - - - - - - - - - - - M
m u 4 UM
' . MAN A8G EE0EAf9WG sevueserv: The praetassa of asias Port 8 gg 2.7H,3.748,3.MS. S.779 Masededl genreathead Isseens) of has ehetera, imunes unene eso, asi es sema. see, as semes* a W amherter see added Therehre. the A _ pertemens to es. et sees. es; es U e c ones. e if ac. see. after Il 194 ,
the lateestate meenseen4 et septmo and umaeus searwems amass. esseemas asse-asse setas pecesses Ipean er aae susnes enant one. see. as same, ses; es rena se famous: emarsatmed areas ne semented b s '" '"""** '''''''''##D Part Te, as - - -; wet met apply to E se m*"ess;8 ss ees
- 10. E==8taa 2.794 of 10 CPR Part 2 hs the endeded area, Iget wtB esatamas to asmonded. and the estados et authority asspty to the -C'" areas donathog 3 2.164 i Aamreded) la l1ti Periher. the reserteatens per=
- 2. A estaden of authertty is added af- fonowing the secues is deleted. to read as foOsws:
tatnias to the intestate meeemeent of ter IitM of IS CFR Part 2 to reed as " tw1ae and avtas gredeets from men. genews. I 2.7 M faserummi
8 ** """"***' "
T1te r %===h n - _ the one of is apply u a $ "*es*[ "*
- mfor-ai precedone - wtm me
, - 2. The last sentence in 3 2.704 sat of Act. seetaeas 541-464 et tatae S of the
, Insofer es the C ^ - as hopese le CFR Part 2 to amended to read as United 8tates Code, and the regulataans certaan furtlese a%@tess acessomsy to fouove; ha this chapter, and utth the orderty een.
prevent the laterep no spread of has duct of the preesodems ame the ====== sty ciastora, tieey samt he sende eSectlee ten- 3 2.794 De-lemmei== .t pre edies dSece, for preserving a anstehts roesed Ser esem to 1 ~ ** t8eser purpose in anagi . .d hdeer. the puhBo lateresa tuadar as tamer m- ,,, . , , ff the Cr=== lad =" dess not ll. Seedon 2Jp3 ef IS CPR Part 2 ts '.
' hees Notetettene. t% atseed to made se provida. the Chairman of the Ateente esecesse promessay hi arder to to et mass- estety and ucensans board, um Cheaf aseended to rand es fossee
"",,g*" D* 8" I 2 888 fleere of rear a=
the admeatettstive This subpart seawas Hw teenance. precedem - ha a Uac asa, tt is pur===at u accuan tot of me AWunde and repena of resetatsens he
,' famed span good etsee tenet messee and Energy Act of ISH. as amended, or. If whicen partacepattaa by lateressed persons other peste pneedere with reagert to the r%== n=d=a has not prertded for is pnmertned ender escaten Sea of title &
the aessadments erp taspraetteatte tes- the heartng to be conducted tur an aimaner neesonary, one eesta ery to the peMie in- safety and Beensins board, the Clues of the United States Code. terest, and esed onese hi found for mak* Heartag Emmanerwr erut inaue an order
- ins thema seectave has than 20 days afte' designating a hesnns esaminer ap- PART 4-NONDtSCERMINATIO98 98 pmem ht the Umsenas nesserum. potnted punuant to accoon 3:05 of uue FEDERALLY ASSISTED CottaAIS.
Done at Wash 2na ton DC, this 14th S of the unsted statn Code. SiON PtOGaAMS-4FFECTUATIOps day of July 1970. . Of TTTLE VI Of THE CIVE E9GMTS ~ i Oar =aa 'r. Karras. Jr., i 2.712 i tanceded i Of N
- Adasautrefor. 4 A citauon of authority la added Agricalfare! Jteerarch Sernce after i 2.713 of 10 CPR Part 2 to read 12. The citauon of authartty foGoving Fued. July is. se7e; as follows: the tahne of secuena la 10 CFR Part 4 to (r a Due. To-oset ' ' ' ""I amended to reed as focows; see stat., tes. 88 stat. los. 6 U 8 C lat. Soop At artv: The provtaneau at teus Pan 4
- 5. Sectaan 2.71881 of 14 CFR Part 2
*~~"'""'"*"'*"-': n'A" " *%'Mram.
Title Il-ATIE DOH $ 2.7I8 Pe.ee of pee. Wine edEcce. *nos- t - anoos-4. Chapter ! -t" Eno'W A presidans omcer has the duty to con- t3. Secuon 4 el of te CFR Part 4 ts Me38# duct a f air and impartial heartna ac- amended to read as follows: cording to law, to take appropriate ac- n uit w%h MfSCILLANEOUS AMENOMENTS TO taon to avoad delay, and to maintam gggpygg order. lie has all powere necennary to slon One or mort members of the Commis-or one or me.ro hearing erammers De Atomie Energy Commission has those enda, including the pou,rrs to: appointed pursuant to acetaan 3195 of adopted the asnendmente set forth below . . . . true 5 of the United States Code shall to the estauons of authority in its regula-
- Take any otM acuon consistent ,,, preende at a heartna and ibt maJte tions tn te CFR Chapter L with the Act, this chapter and sections findings of f act and conclusions of law if in add 6uon, omer amendants of a 558 of uue 5 of the UnM Stain an appincant nr recip6ent walvte a hear-correcuvo editertal nature, such as cor.
muono to statutory nfmnoes han ins and sutanits written information or been adopted. 6. Eecuon 2 7194ss of to CFR Part 2 anWnent for me Mcord in enordance Stace the amendments are of a corree- to amended to read as follows: sith I 4 Slidt. ttve editettal nature and no substanure l2.719 Ecpaestlea of funetlaan, cunges to the resulauona are efM fa n A presidins omoer shall perform 10 CFR Part 4 la amended to read as good cause esista for omitung nouco of no duuce inconsistent with his reuxmst- gogio,,: prm a==rt rule staking and public pro-cedure thereen as unneceenary. and for ballues as a presiding omeer, and 311: not 0' J ""** " N"*"* **d "d-maJting the assendmenta eSecure etth- tw responsible to or subject to the su- . ' n' The hearing. decision. and any ad. out the custeemary 34-day nouce. - petitsaan or direction of any omeer or mesun nvlow thereof shaB be con. A#**'d
- N "*" A employee engaged in the performance of ducted In conformity with escuane Energy Act of 1964, as amended, and ese- investistuve or prosecuuns funcuona.
tiene 642 and 643 of utie 8 of the United * * *
- SM-551 of uue 8 of the United States Statae Code, the fonowing amendments
- Code, and in accordance with such pro.
of Chapter 1. Title le of the Code of 7 A citauon of authority is added after cedures as are proper s and not inconsist. Federal Mesulauces are puhushed as a i 3 719 of to CFR Part 3 to read as ent with ll 4 88-4 448 "relaung to the dncument subject to codificauert to be follows: conduct of the hearing. giving of no4&ces eSecuve upon putaticauces in the res* see stat 644. 8 U s e ase) subessivent to those pre,tded for mi g 4Ja. nas Rassena.
.I 2.731 H ane=dedl taking of tesu=aay.eshshns arsussenes.
PART S-4ULM Of PRACTICE 8 D* '88"U"" ***"it' "#88' and brieta, reeusene .for. ,endines, and L no estauen of authority fenewing 12331 to essended to med as fenow ,g,, ,,g,,,, ,,,gg,,,, the tebas of eseeanne as to CFR Part 3 to , , , , , assended to read as tenews: <sse. ist. se ease east es esa seau sausass asseses, vet. as, see tas-seene, Jute ty, two
W IIsee Ruta 5 AM. essenA190008 PART F-ADVISORY DOAROS PART 31-4SMA& UCM Pgg e seesses(43 and ten w user am a ~ tB. sectica T I<an of Ie CPR Fort T SYP9000CT MATM s is amendes ce aged as follows g[t.w
- MM e.e.PAff M-8X. PORT AfS=AT===
MIPOST OF i T.1 r ry e, ,,, 6, T, svP.O UCr
- a.e ,es,,la,ttoor, o ,e es ,, m. _,, ,,,, ,.,.,.,. - is os- io ,s.d . ., tes. r. m Theom.es.e,e the takte of asemene M g.es.,.e.o C55 Fue a suant to secteene ISIA 30,30. and ISTa. *"**"***'***e- 88e* 88. # 8088* GE set m4. se a of the Atomete Eneroy Act of 1964, as seen Per the perymageas of WAEoss, Mstas.
es sheLens. le annended to sued as $dous: A*TummerrT TIse pauseutume et mig she e aNOded iM Stal $193. to the etteSt Do4 ene. mesaded. es USA mee. 80 stA4el inconustent s 4th =p isen. law. aan. sa rias ame 88.8Itel immune amour sea, teamme unser soun, et, es, see. 35 see. e mas. t e . . es osaa see, se ====d=d* es U Aa M eso,see see.see,enensmaust G sA A Stst.
. . . 3113. M. M M Fer es pepoems af aus.
tap. see, as asas, eso en - es saa case. PABT 1 W tlA AND PROC 3 PART 33-SP9CWIC UC305M TO sete, se seseas<e: same. eso, ene seAsut amuse ameer est se esammame; es v4a Dutt$ POR ORTHMINING Etim- MANUPACTUGEs DISTESUTE. OS seontes. SEITY POS ACCESS TO RESTttCTIO IMPoti EM A88 OGM. DATA OR DtFW45E DdrotMADON ALLY UCDe5W ITEMS CONTAsses PAtf N OPSOtma
- 18. The citation of sethority fonowtns BYPRODUCT MAT 9etAL MATM
- 23. The citattee o 37. T *
- g - ino o taE of e.st.f e.gam.e i. C f.em.me. r. Lt.e t he em et 6. . .R ,".". 3 e ofe.see.e Arvimostrv. De , - - or this Part
- le 33 is kmended W W a seBsMee to Is SEsEdad to rehd M h* '
# th' '"8 'h'" '* *8 ** f***** A*T=amerT: The pseewemme er man rese AYs*Is[eIn s."e ie $ siat us'. Por the purpasse of use, m es sent see, as to tasame acteur east E m. m. E 3m se, as ma===d=a e U s C. snet E O 1000. le F 3.
34 0. 3 Crut loco-leGe erump. p. see. me a ==adad 40 &C 3fte.98Sols.Saad.*J R" 38e. esUAE 8e oE*LMeso.M MM M eE M Ma. as an==ad=d EOL tegen. Se FA. Bles, s CFB s2seie). ssseien. Sa E seJa. SSAa. Se.S "a's"s't Eme, . 'd"d h natums senergene asesA gas. t#36-Jess cump, p set, es amended, a Cyg tesume under eso. lose. es enet, see, as tama es to ame humme unsur set 3e8 e met nonseded. 42 U e C. met tel, 1eserumean,y alt see. es ----m
- es e an some, per me p Y,3 remes er sea. see, e same, one, as --a=* es ,
3 19.11 I taneedeJ l 197
- 17. Ttw citataan of authority after PAtT 33-5P9CPIC UCENSES Op U se seis. e etes ses amuse emisme one, asem.
11011 of Ie CFIL Part 10 le deleted. 8 ROAD SCOPE POR SYP9000CT i " "**i m***m j m# # E U '[e*" d'* MATERIAL es esas. see me ===.a=+ es san assetes.
- 23. The citatson of authortty fonowing II E21. 4&34 (Anamaded]
PART 20-5TANDARDS FOt th' *** C' "etsens an to CFR Part 33 Se. The attattom of aeshartty aft..' PROTECTION AGAINST RADtATION to amended to ned as renows: Il tel3 and 4034 of it CFR Part 48 le
- 18. The citataan of authority foGowtrw AoTwoerrT; The prwissene er thne Part as delseed.
the table of sectaone to 10 CFR Part 30 teseos under esea et 181, tea. tea. es same, as amended to read as fonows: ne. Ms. eas. su. es -- 4e U Ac. si t t. I48*73 I Ae***ded l aw.arrv. Tne prwasome or tsis Part se ssos assa. sus per su purymme er sea. aas
--d=.e-
- 30. A estaden of authertly is adena n.su.e ammer seen. es. es. es es. toe.104. not, es stat see es e
es Uma sen. after i ET1 et 14 CFR Part 40 to send se m.aa. est ess. na ess. ut, ses se 8 88 87i*1 l'cuse under ese istA es mee, as foDoes:
-- a ed Us c. 3r7s, some. 30e4. 3:Is. He. as U e anosgn).
siss. ::M. sset. Par the perpenas er e. ssa, teses see. tot es mee. see; es s&R met se osaa. see. se ==== dad es e e c. arts. 88eT) si m oon.za eos. teseos unese nee. iste. es PART 34-UCIN$ts POR RADIOG.
; esas. us, as amendes. As U s c. sso ces. RAPHY AND RADIATION SAPRTY PAtf SG-UCDeSBe8 OF PROSUC. I I EEQUIREMENTS POE RADlO- T10N Ape UTE!ZATION PACEmW !
PART 30-TULES OF OENERAL APPU. GEAPHIC OPitATIONS as. The h of aaniartly saaeweeg I' CAaauTY TO UCEN58NG OF BY. 24. The citatson of matherity following the teme of seseems am ne CPR Fort se PRODUCT MATIttAL the table of sections in le CFR Put M 18 asiaaded to read as femows: is. The citataan of authority following **'"d'd "*d **I*"* "-
- sama *smeer man rese s'"tee". tea, see, sE see, se'n"umee"'unear the table of swtaone in 10 CFR Part 30 to AvTmoarte; The pretesans of tale Part se i
to met see, en ees, em see, em asumenet amended W read as follow, . . Laevee ggg, under gg egg gg4 seca.
,, e.ta.a.
tel. eg IM.glee. 3 nes3333, stat es UAC. stes. site. Seet. M E umbess AUTucesTT : The prwistone or this Part so asot. s2ss. 2288. Few the purposee er see. g otherwtse noteA emenene an an om me egne gn. i tesume under soma et, es. Bel. les 188. se es stat e6e as amended; 43 UAC. Sets. ause mader see. tot, se sena etc. as - ! stat see. see, see, see, as a-dad- ts '?s C. Si s4 sede1. 5430. SeJT. MJethl. and et.es to UAO, ease. ensuono atteD-eksm In-Stil. St ts. Stet. sses, sses. seruon (d) leeuse under see. tete, es stat see, as ones under see, tee. es seat east es v4A amended; as U S C. Ses4e). Sees. Per the perpenas et see. SW. M sent seM(op also lassee under ese IM. es stat see, se ==aad=d 43 Us C. s2 4. Por the pure see, as new es UAa gege. $ tase(l) poses or sse. es stat. etc. se amenase. As PAR 7 35-HUMAN U$ES OP t"**e uname me. test. m sent esse a vaa us c. : 7s. e semm issuee under on. ist TYPE 000CT MATItlAL o as etas. Me: es U s a ssoitel and 88 aste."'a' seas.
*** 8 see8 **", se -I--a=*
'""** ""*"v es &R se seat ame seas seseos emeer en tot e es 24. The ettat&on of authority fouowine asette).
stat. see as a===ama to Us C. as;t(ep. the table of sections in le CFR Part 34 g gg,gg ga a j
$ 30.61 [ Aanseded) le amended to reed as foueve St. The attatten of aestimertly ar %r St. A estauen of authority le added to 497m:mr71 The preteams et tabas Pere et
$"*g* ,"*,d*',',*** ,edtee, t sema. ,i,80.10 of it CFR Part 84 to t===amd te
,g ,,g,g ,,,,
i 30JB1 to read ae foGows: , ,, g ,
*(esse. tee. Ist es stat. ese; es Usa sses. 3Jol. ases, sses Per she purymeme et essene (sema. let.108. Se stat. set see, as asesment serf) Ste. es sent eH. es esmeados; es U AO. N1s. 40 U s C. stst. asse)
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' RULES AND REGULATIONS r_ .
FEDERAL REGISTER REPRINT
. ~ . _ _ .
Title 10-ATOMIC BIERGY Chapter 1-Atom'ic Energy i ommission . PART - HUMAN USES OF BY DUCT MATERIAL Technetium 99m for Solivary Gland r and Blood Pool Scans Notice is hereby given of the amend-ment of the Atomic Energy Commission 3
' regulation "IIuman Uses of Byproduct Material," 10 CFlt Part 35.
Scction 35.100 of 10 CFIt Part 35 lista two groups of diagnostic uses of by-product material with well-established clinical procedures. Section 35.14 states that the Commission will consider an application for a specific license for any diagnostle use listed in Group I or Group II of 135.100 as nn app!! cation for all i of the uses within the group if the app!!- cant is qualined. The use of technetium 99m as per-technetate for salivary gland and bloci pool scans has become a well-established clinical procedure. The amendment te; forth below adds to paragraph ebe. Group II, 1 35.100, the use of technetiu.T. 99m as pertechnetate for salivary gland and blood pool scans other than placenta
, localizations. , Decause this amendment relates solely to minor procedural matters, the Com-
{ mission has found that good cause exists j for omitting notice of proposed ru!e 4 making, and public procedure thereen. in as unnecesary Since the amendment re-j heses from restrictions under regulations } currently in effect, it will become effec-tive without the customary 30 day notice. 8 Pursuant to the Atomic Energy Act of 1954, as amended, and sections $52 and i , 553 of title 5 of the United States Code. the following amendment to Title 10. m Chapter I. Code of Federal llegulations. h Part 35. Is published a.s a document subject to codification, to be effectne upon pub!! cation in the FrorR AL Rrcistra [g-(3-5-71). Paragraph (b) of I 35.100 of 10 CFR Part 35 is amended to add technetiu t o 93m as pertechnetate for salivary glani (, and blood pool scans other than placenta f localizations as follows: 8 33.100 Schedule hCroup, of elb - F no.fic u.cs of bygumluct snatcrbl in l umans.
- (b) Group 11. Scans .ind tumor loca11-zations. - ~
( . . . . .
- r. (15) Technetium 99m as perteclute.
tale for salivary gland and blood pool 5 . scans other than placenta localhations. l FIDraAt #fGilff e, VOL. 36, 740. 44-481 DAY, M ARCH 5,1971 i
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RULES AND REGULATIONS _ 4369 (Sec.163,68 stat. 948; 42 UE.C. 2201) Dated at Washington, D.C., this 10th day of February 1971. For the Atomic Energy Commission. W. B. McCook Secretary of the Commission. [P!1 Doc 71-3028 Filed 3-4-71;8:47 aml FEDE$AL tlCISTER, vot. 34, No. 44-f RIDAY, MARCH 5,1971
RULES AND REGULATIONS 1271 time are identical with the aforesaid rec- not prohibit (1) a vcluntary gift of nom- tive upon publication in the FtntRAI. cmmendation of the committee. and in- inal value or don: tion in a nominal RrcrsTra. f:rmation concernirg such provisions amount made on a 3 pecial occasion such Pursuant to the Atomic Energy Act and sfrective time ha. i been disseminated as marriage. illness , or retirement, or of 1954. as amended, and sections 552 among handlers of 3 :ch Navel oran;;cs: (2) A loan as dese;; bed above of snore and 553 of title 5 of the Umted Str.tes it Is necessary, in ort er to effectuate the than a nominal am: unt where a special Code, the following amendments to Title decl red policy of tl e act, to make this personal or busines , relationship is in- 10. Chapter I. e of Federal Regula-section effective duri. Lg the period herein volved. with prior aparovalof the higher- tions. Parts 20. 31.32.34.35,36,40 specifledl and comp ance with this sec* ranking employee's < upervisor, af ter con- 50,55,70,71.7 tion will not requ:re 00.115,140. and 150, ny mecial prepara- sultat:en with the e mnselor for AEC, or are published as a document subject to ti:n Cn the part of pe sons subject hereto a deputy counselcr, as provided in codification to be effective on January 11 which cannot be cor: pleted on or before 10.735-3 t h) . A cory of such approval 1973. th3 effective date her 'ot Such committee shall be filed as provided for in 5 0.735-mteting was held on January 9,1973. PART 20-STANDARDS FOR n8'e)(11)* (b) Order. (1) T. e remective quan- , , , , PROTECTION AGAINST RADIATION titi:s of Navel orang 's grown in Artzona and designatt ed part af California which a Section 0.735-4: of Subpart D. Chap- 1. Sections 20.402 (a) and (b). ' 0.403 Title 10 of the Code of Federal Reg- (a) and (b). and 20.405(a) are amended ry 2 3 th o J ua 1 973, ter I'ons ulatt is amendedto read as follows; by titu ing "Re ry Operations U2 h:reby fixed as fcdows: g0.735-45 Emplo: ce indebtednen. pliance 05ce" and substituting "Direc-11 ) str et 2: 15 000 ca ! . Except as providrd in 9 0.735-42(d), tor of Regulatory OperaLions" for"Direc-(lid District 3: 40 the AEC considers t1Le credit atYairs of its tor. Division of Compliance." (2) As used in th!! 000 cartons'andled section. "h " employees essential;r their own concern. 2. The heading of Appendix D is 3'* IIowever, employees trairs
- District 1 " " Distr- :t ~ are expected to con- amended by substituting " Regulatory and " carton" have t; te sa *'m" meaning e" District s duct their credit in a manner Operations Re when used in said ;tmended marketing which does not re iset adversely on the pliance Omces.ponal OOces" for "Com-agreement and order Government as thet.' emplo3 er. The AEC will not be placed in the positien of act-(secs.1-10,4a stat. 31 as amended: 7 U.s c. ing as a collection agency or of deter. PART 30-RULES OF GENERAL APPLI.
cot-e79 mining the validity or amount of con- CABILITY TO LICENSING OF BY-Dated: January 10, 1973. tested debts. An employee is expected to PRODUCT MATERIAL PAC! I oper and ime er es ially n 3. Section 30.32(a) is amended by sub-
. Deputy Direc tor.. A. Nzenot.
Ertzit a son'nd imposed by law suci: as Federal. State, or stl&uting " Director of Ucensing" for "Di-Vegetable Dmtsfon, Agricut-fura! Marke!ing Sert' ice, local taxes. Failure < n the part of an em- rector, Division of Materials Licensing." ployee without good reason to honor just 4. Section 30.55(c) is amended by sub-IFR Doc.73-786 yuen 1-10-73;13:50 pm] financial obligationa or to make or ad. stituting " Director of Regulatory Opera.
- here to satisfactorr arrangements for tions" for " Director. Division of Nuclear
- settlement may be cause for di.cciplinary Materials Safeguards" and for " Division THlUif a 10 sv 111 Ultilu LIRllu IATfilll?
action. For the purrose of this rection, a of Nuclear Materials Safeguards." Dll'DQV "just financial ob! gation" means one ChoPter I-Atomic Ene,9Y ackn wiedged by t te employee er re-duced to judgment >y a court. and ,in a PART 31-GENERAL LICENSES FOR Commission proper and timely :nanner" means in a BYPRODUCT MATERIAL PART 0-CONDUCT OF EMPLOYEES manner which AEC determines does not. 5. Sections 31.5(d) (1) and (5) are 5:licitations an f Indebtedness tmder the circum. .tances, reflect ad- amended by substituting " Regulatory versely on the Government as his Operations Regional OSce" for "Re. The Atomic Ene rgy Commission is employer. gional Compliance O2ce." amending Part 0 cf its reculations con- Dated this 4th da y of January 1973. 6. Sections 31.6(a) and 31.11 (b) and cerning the credit alSirs of its employees. (e) are amended by substituting "Direc-Deciuse these am4.ndments relate to a Pm C. Em. tor of Licensing" for " Director, Division m;tter of agency management and per- &cretary J th Commission. of Materials Ucensing." sonnel, notice of p:oposed rule making IFR Doc.73-673 Fu rd 1-14-73;8:45 mm) and public procedure thereon are un-
" PART 32-SPECIFIC LICENSES TO i
fl na r[11$73 MISCELLANEOUS AMENDMENTS TO MANUFACTURE, DISTRIBUTE, OR Part 0 is amended as set out below: CHAPTER IMPORT EXEMPTED AND GENER.
- 1. Section 0.735-12td) of Subpart D. ALLY LICENSED ITEMS CONTAIN.
Ch pt;r I. Title 10 o; the Code of Federal The Atom!c Energy Commission in lons is an ended to read as early 1972 announced major organiza-tional changes in the regulaMry staff. ING BYPRODUCT MATERIAL Commission regulations contain numer. 7. Sections 32.12, 32.16, 32.20, 32.25 6 0.73M2 Cifts, ente rtainment, and ous references to the previous crganiza. (c) . 32.29(c). 32.52(a), 32.56. 32.60 and faors. tional units with respect to the filing of 32.63 are amended by substituting'"Di-e . ,
. . applications and reports. nctor of Ucensing" for " Director. Divi.
(d) An employee shall not solicit a The amendments of Commission regu. sion of yaterials Ucensing." contribution from r nother employee for lations set forth below change the names C sift to an occial : upenor, make a do, of the former regulatory divtstons. Re. n tion to an ometal cuperior, or accept a gional Compilance OCces and Distnct PART 34---LICENSES FOR RADIOG-gift from an emplo: ce receiving less pay Safeguards O*3ces to conform with the RAPHY AND RADIATION SAFETY than himself (5 U SC. 7351) nor shall names of the new regulatory umts. REOUIREMENTS FOR RADIO. m ese amendments We NE NAMM an cmployee direct! ' or indirect!Y so!! cit solely to agency management, and minor from, accept from. of!cr to, or grant to matters, good cause exists for omitting 8. Section 34.25(d) is amended by sub-an cmclal superior or subordinate em- notice of proposed rule making, and pub- stituting " Director of Ucensing" for "Di. ployee a loan of rr ore than a nominal lic procedure thereon. as unnecessary, rector. Division of Materials Ucensing" . amount..Ilowever,mhis paragraph does and for making the amendments effec- and substituting " Regulatory Operations i g FIDERAt REGl$ftt, V0t 38, NO. 7-THUR$0AY, JANUARY II,1973
1272 RULES AND REGULATIONS Regional Omce" for " Regional Compli. rector of ucenstar.17.5. Atomic Energy Com- loss, other than normal operating loss ance Omce. - mission. Wat.h Lngton, D.C. 2050. of special nuclear material.
- 17. In I 50.55(e), s.bparagraphs (2)
PART 35-HUMAN USES OF and (3) are amended by substitutinc PART 71-PACKAGING OF RADIO-a aum Remnal Omce" BYPRODUCT MATERIAL for
- Regional Compliance OSce" and ACTIVE MATERIAL FOR TRANSPORT AND TRANSPORTATION OF RADIO.
- 9. Sections 35.31(b) and (d) are substitut,ing " Director of Regulatory Op-amended by substituting " Director of Lg. erations fer
- Director Division of Com- ACTIVE MATERIAL UNDER CERTAIN censing" for
- Director, Division of Ma. plian:c", and subparagraph (4) is CONDITIONS terials Licensing " amended by substituting " Director of 25. Section 71.10 is amended by substi-Regulatory Operations" for " Division of tuting " Director of Licensing" for "Direc-Compliance, tor, Division of Materials Licensing",
PART 36-EXPORT AND IMPORT OF 26. Section 71.61 is amended by substi-BYPRODUCT MATERIAL PART SS-OPERATORS' LICENSES tuting " Director of Licensing" for " Divi-
- 10. Sections 36.2 (a) and (b), 36.11, 18. Sections 55.5, 55.10f a), 55.60, and s n a eMa s 1.iceyg%
36.22(c), and 36.24(c) are amended by the note u hich follows 55.60 are amended substituting "D; rector of Licensmg" for by substituting " Director of Licensing" PART 73-PHYSICAL PROTECTION OF
" Director, Division of Materials Licens- for " Director, Division of Reactor Licens. SPECIAL NUCLEAR MATERIAL ing" and for " Director, Division of State in g."
and Licensee Relations., 27. Sections 73.5, 73.31(d), and 73.42 are amended by substituting "Ddector of PART 70-SPECIAL NUCLEAR Regulatory Operations" for " Director, PART 40-LICENSING OF SOURCE MATERIAL Division of Nuclear Materials Safe-MATERIAL E"* "D '# " #"#
- 19. Section 70.5 is amended to read as terials Safeguards , and substituting
- 11. Sections 40.5 and 40.23 (a) and (e) follows
" Regulatory Operations Regional Omce" are amended by substituting " Director of $ 70.5 Comnmnications. for " District Safeguards Occes."
Licensing" for "Di of 28. Appendix A of Part 73 is revised Materials Licensing, rector, and for Daision
" Director, Except where otherwise specified all Division of State and Licensee Relations ,. commun! cations and reports concerrling na as o ows:
- 12. The first sentence of f 40.31(a) is the regulations in this part and applica. Arrznotz A amended to read as follows: tions filed under them should be art- U.S. ATOMIC rNrRcY eOMMIssioN dressed to the Director of Licensing, U.S. arct x.aront oernarrows accioNAL oFTICc3 8 40.31 Applications for specific li. Atomic Energy Commissiorf, Washington.
een ses. D.C. 20545. Communica tio ns, reports, and 'retephone (a) Applications for specific licensts applications may be dehvered m person Recon and addnss ., abould be filed in quadruplicate on Form at the Commission's oSces at 1717 H a[ay, AEC-2, " App!! cation for Source Ma- Street NW., Washington, DC; 7920 Nor-terial License " or on Form AEC-7, "AP- folk Avenue. Bethesda, MD; or at Ger-p11 cation for License to Export Dyprod- niantown, Md. R.$on cutI.wry, lure opranom, torate or
, uct or Source Material" as appropriate, 20. The first sentence of I 70.21(a) is NaY.'NoSiE...'. .St-us ruo :ot-4i5 re Mth the Director of Licensing, U.S. , amended to read as follows: 8*"".h""'""
Atomic Energy Commission, Washmg-ton, D.C. 20545. * * * $ 70.21 Filing- . m i ,rbtree st. w ., e . e e e (a) Applications for licenses should be dyff'ih,M,$g;r* ~8d " *-88 "
- 13. Section 40.64(c) is amended by filed in sextuplicate, provided that 25 H. ru m n raum, substituting " Director of Regulatory Op- copies of an application for a license to [$'; pre.$ o,yf 5 erations" for " Director, Division of possess and use special nuc! ear material ce r. .. . . ............ .. . 3:2-6ss 2eeo si2-mm t Nuclear Materials Safeguards", in a plutonium processing and fuel fabrication plant shall be filed tvith the Eg,.,I regi eg rs.uc. atit sancrors' Director of Licensing, U.S. Atomic Way, Derkeley, CA HM. 415-441-St?t $15-481M4 PART 50-LICENSING OF PRODUC. Energy Commission Washington, D.C. (E a 644 TlON AND UTILIZATION FACILITIES 20545,* rde the purposes of this regulation, the geo-
- 14. Sections 50.4. 50.30(c), and 50.59 graphteal areas assigned to the Regional are amended by substituting " Director of 21. Footnote 1., which follows I 70.22 omces are as fottows:
(b)(1) is amended Recrow I Licensing" gg* for ".D, irector, Division of Re- rector of Licensing,,by forsubstituting *Di*
" Director, Divi-
- 15. The first sentence of I 50.30(a) is sion of Nuclear Materials Safeguards", Connecticut. Ataine, Marytand.District Delasste. c,f Columbia.
Masaachusetts, New amended to read as follows: 22. Section 70.39(d) is amended by Hampshire New hrsey, New York, Penn. l substituting " Director of Licensing" for eytrants, Rhode Island, and Vermont. E 50.30 Fil,n g of applicat,one i i for l,- " Director, Division of Materials Licens-i censee; oath or affirnu tion. ing". RIctoN II (a) Place of firine. Each application 23. Footnote 4., which follows I 70.51 Alabama. Arkansas. Mortda, ocorsta, Ken. for a license, including whenever appro- (c)(1) is amended by substituting "Di- tucky, Loutstana, Ettssissippi. Nerth Caro-priate a const.uction permit or amend. rector of Licerning" for
- Director, Divi, tina. Puerto Rico. South Carolina. Tennes.
ment thereof, should be fUed with the sion of Nuclear Materials Safeguards", en, vtrstnia, and west Virginia. Director of Licensing, US. Atomic 24. Section 70.52 is amended to read as RectoN RI Energy Commission Washington, D.C. follows: niinois, Indiana, Iowa, Kansas, Michigan, 20545.* * * $ 70.52 Heports of acci<lental criticality Minnesota, Mtsmourt, Nebraakt. North Da. e e e e e or loss of special nuelcar niaterial. kota, Ohio, Oklahoma, South Dakota, and
- 16. Footnote 1 of Appendix E 19 Each licensee shall report immediately wisconsin.
amended to read as follows:
- to the Director of the appropriate Atomic Rutow V s'Ito guide is available for inspection at Energy Commission Regulatory Opera. Alaska, Arizona, California. Colorado, Ha-the Commisalon.s Pubtle Document Hoorn, tions Regional Omce hated in Appendix wan, Idaho, Montana, Nevada, New Muloo, 1717 H 8treet NW., and copies may be ob. A, by telephone, telegram, or teletype, Oregon. 'Ivmas, Utah, Washtngton, and tatned by addressing a request to the Dt. any case of Sccidental criticallty and any Wyoming.
i FEDitAt stCasite, VOL. 38, NO, T-THUt3 DAY, JANUARY ll,1973
M g{ 2aA;f-1. //
- N ' 7 '3 f
;1 PROPOSED RULE MAXING i dministration 'Ro im 5221,400 Seventh 6399
- beet SW., Washi: gton, DC 20590. It is comes available. L . the docket after the L
closing date, and 1 is recommended that physician named on the license may ob-requested be submitted.but natI. quired that 10 copies interested persona continue to examine tain basic and clinical radioisotope train-the docket for ne' ' material. ing and ' experience to enable them to All comment: rec tved before the close Comment closin ' date: May 4.1973. qualify as authorized users. f, .of business on hei < omment closing date Proposed effect. ce date: Six months 3. "A. Byproduct material shall be used r ,^ Lij %cated belon e i be considered and after issuance of he final nile. be availab: by, or under the supervision of, indi-
> fo examination in the This notice of p oposed rule making is viduals designated by the (name of In-i* ocket at the a sov< address both before issued under the authority of sections stitution's isotopes committee).
m snd after the c:2 sir g date. To the extent 103, 112. 113. 119 and 201 of the Na- "B. The use of byproduct material in i possible, commi nts filed after the com- tional Tra!Bc and Motor Vehicle Safety or on humans shan be by a physician." 4 ment by the closing da:e Adminis' rat] :n.rHowever,
- 11 alsothe berule considered Act. Public Law 8 v563, 80 Stat. 718,15 This condition is used in ilcenses issue :
, U.S.C. 1392, 1401, 1402,1407, and 1421 to medical instituuons-usually med. cal
- sking actionan! itay proceed at any time and the delegatio ts of authority at 49 schools.-whose isotopes committees have l
' after the date, siter the closirsd ate comments received CFR 1.51 and 49 ( FR 501.8 set up appropriate nriminhtratlye pro-l and too late for cedures, and training and experience cri- ' ~~-
[ considerauon res Ard to the action in tions for future rule w1U Issued on Martl 1,1973. be treated as sugge teria, for the committee to approve in-E I making. The A:im nistration
' wiu con- .
R< sent L. CARTER-dividual users. This condluon also anows tmue to file rek va t material, as it be- Assock te Administrator, other physicians to obtain training and Afotc Vehicle Programs. experience under the supervision of a g m ,, % physician designated by the committee as an authorized user, guan n e w uc,canuatauuna- W" h** It is recognized by the Commtulon that physicians utilize technicians and Aconss other paramedical personnel to perform
,,,,,, eny a arr u some of the activities and manipulations Om involved in the medical uses of radioiso-IMPoRTANr: EO RAL LAW REQu,REs E "Ta^o topes. In such instances the physician is Tm Rrcono: 'o ce Tms mowAnoN.
s o r v. motiot%f* AYsoas w m *S still considered to be the user of the 4 radioisotopes. The Commission has de-m utashwe
, , , r , , , , , , , Veloped with the assistance of its Advis-ory Committee on the Medical Uses of
' ' ' ' ' ' ' ' ' ' Isotopes a list of responsibilities which nonus
, , , , ,- , , , , , ,' shau not be delegated by authorized phy-cm sms
,, , , 3, u
sician users of radioisotopewxcept to ea ,,, , , , , , , , , , , , other physicians who are under the w sirr supervision of authorized physicians--
, , , and a 11st of activities that may be dele- 4
.F10. 3- STANDARD FORA 4 gated by physicians to technicians and other paramedical personnel. The pro-Ira Doc.73-4445 Pued 3-4-.73;8:46 ami PL6ed new I 35.32 would codify these non-delegable responsibillues and permissible ~
ATOMIC ENERGY COMMISSION to conform to this new utie wiu de made delegstions in the Commission's reguia- [10 CFR Part 35] to this and othe* parts of the Commh. tions. section 35.32 would also require ston's regulations perwning to byprod. . physicians to determine that technicians MEDICAL. USES OF RADIOlSOTOPESuct material. and other paramedical personnel are In its licensing of the medical uses of property trained to perform the activi-k (BYPRODUCT MATERIAL) User and Reporting Requirements radioisotopes pursuant to 10 CFR Part 35, ties which are delegated to them, Cer-
'Ihe Atomic Energy Commtuion has the Cornmtuton requires that the respon. tification in nuclear medical technology by either the American Registry of regulations in 10 CFR Part 35 "Hemun State or territory of the United States, ofby under consideration amendments to its sible user be a physician licensed a Radiologic Technologists or the Registry -
Medical Technologists would be Uses of Byproduct Material," to: (1) the District of Columbia or the Common, , Chanze the title of the part to " Medical wealth of Puerto Rico to dispense such drugs deemed to satisfy the requirement for proper trMntng; however, the Com-Uses of Radioisotopes (Byproduct Me in the. practice of medicine. Physicians mission does not consider it necessary to tertaD," ties (2) specify of physicians certain authorized responsibill-to use radio- condition are authorized of specific or to use radioisotopes general licenses by a require paramedical petsonnel who only isotopes for medical uses. (3) specify issued by the Cm"'"Wn. One of the fol. assist physicians with simpla manipula-certain activities that may be delegated lowing three standard conditions is in- be tions or in programs of limited scope to fully trained and certified by physicians to tech'*'=m and other cluded in each specific license issued for technologists. paramedical personnel, (4) require phy- medical use of radioisotopes: s:ctans to determine that technicians and 1. "Dyproduct material shall be used by Commission's Section 20.401 of 10 CFR Part 20 of the regulations other paramedical personnel are properly (a named physician)," This condition is requires 11 trained to perfonn such activities, (5) used in licenses to physicians in private censees to notify the Commission of in-require reporting to the Commission of practice. cidents involving the exposure of individ-rrhadministrations uals to more than certain statedsection 20.4051c) reation therefrom, andof (6)radioisotopes require no- by, or or under, 2. " the Byproduct supervision material of (one shall or be used amounts of radiation, tdcation to the patient or a responsible more named physicians t" This conditi6n requires that any exposure of an ind!- vidual to radiation which is required to tration of rehtire ofthe patient of the misadminis- is usedYlicerisW1.Uued to medical in- be reported to the Commission shall also therefrom radioisotopes or radiation stitutions which have medical isotopes be reported to the individual. However, the patient. which could adversely affect committees to rettew all prcposals for since 120.107 of 10 CFR Part 20 provides uses of isotopes within the institution. that nothing in the regulattons in that The title of 10 CFR Part 35 would be The named physicians are those desig- part shall be interpreted as limiting the changed by the proposed rule to " Medical nated on the application for license as intentional exposure of patients to radt-l thes of Radioisotopes (Byproduct Ma. having appropriate nuclear medicine ation for the purpose of medical dias-
%"tati" to make the title more meaning-fd to users of radioactive material.The If phrase "or under the supervision of . training and experience with isotopes have not been required of incidents in-
% rule is finally adopted, amendments physicians provides a means tmder the supervision wherebyof a nonapproved volving the exposure of patients to rad - ~ '
tion if the patient were receiving any FEDIRAL afGittle, vot. 3's, NO. 4MelOAv, match 9, le73
6400 PROPOSED RULE MANANG
- Intentional medical caposure. Although incidenta invoJving medical exposures to patienta of radlauca from Nh-have not been required to be reported 12 tope cources, Radiokcic '1Vehrologists or in nuclear
- Instances of mtsadministrations of radio- (2) The prescripuon of the radiophar- med) cal technolo(y by the Registry of acuve materials involving 20 patlanta maceutical or source of radlauon and the Medical Technolcansta of the American have been brought to the r'^*Wn's dose 63) or exposure to be adrr.tnistered, Bootety of C11niod Pathologista sitt be attention. BLnce theae incidents have administration, The determination of the route of deemed to sauaf> the training require-generally involved accidental or erro- 44) menta of paragraph (d) (1) and53) of neous exposures of patients to radiation The interpretation of the resulta this(f) secuon.
In amounta or forms other than intended, of diagnostic procedures in which radio- An applicant for a 11cenae or for it does not appear appropriate to con- pharnmceuticais ic) are administered. anwndment or renewal of a !!cenae sha!! Linue the past practice of not requiring Subject to the provlatons of para- state whether he deelres to permLL tc< h-reporta of such misadministrations of graphs necthon,ib). id), te), ti), and (g) of this nicLans or other paramedical personnel rtullonctive materials to medical patients an authorised physica.an may to perform acthities pursuant to para-The proposed new paragraphs (a) and permit techniciana and other paramedi- graph (c) of ulla secuan and,if so. shall h) of 5 35.33 would require !!censees cal pcrnonnel to perforrn the following include in his application for license. to rcport mtandministrations of radio. activities: (1) license amendment, or hcense renewal a pharmaceuticals or radiation from by- testingPieparat)on and quality control statement of the acuvities to be so per. product material sources to the Com- of radiopharmaceuticals and formed and a descripuon of an adequate minalon. Paragraph (b) of I 35.33 sources of radlauon, program for training (including retrain-would also require a notification to the (2) Measurement of radiopharma- ing as required to keep abreast of devel-patient or to a responsible relative of the ceatical opmenta in technology) such personnel (3) doses prior to administration. Use of appropriate instrumenta- or for otherwise determining that such patient of a misadmintatration which could cause a demonstrably adverse ef. by tion for the collection of data to be used personnel are properly trained to per-the physician, form their dutie.t With respect to 11-fect on the patient unless in the phys 1 clan's professional judgTnent such notif1 (4) Administration of radiophar. rule censes
), in effect on (effective date of cation would be contrary to the best in. rnaceuticals and radiation from radio. who destres a licensee who is permitting or terests of the patient or a surviving rel. 1sotope sources to patienta, within Itmits other paramedical to permit technicians or ative of the patient. (In accordance with otherwise permitted under applicable activities personnel to perform the Freedom of Information Act and 10 Federal, pursuant to paragrath (c) of (d) State or local laws.
CFil Part 9 of the Commission's rules and Authorized physicians who per. required this section by shall file the information regulations, copies of reporta filed under mit activities to be performed by techn1 this paragraph with the I these proposed rules, except for any de. clans and other paramedical personnel Director of Ucensing. U.S. Atomic En. ergy Commission. Washington, D C. talla which would identify the patient,shall: pursuant to paragraph (c) of this section 20545 with his next application for will be available for public inspection) Pursuant to the Atomic Energy Act of (1 > Prior to such permission, deter, amendment or renewal of the hcense or 1954, as amended, and section 653 of title mine that such techniclans and other whichever within 1 year of teffective date of ruler, occurs first. 5 of the United States Code, notice is paramedical personnel have been prop. tg) Whenever a technician or other hereby given that adoption of the follow, erly trained to perform their duties. This Ing training shall include tralning in the paramedical perscn administers a radio-amendmenta to 10 CFR Part 35 is followmg sub)ccta, as applicable to the pharmaceutical to a patient by infection. rontemplated Allinterested persons who dullen anataned: a physician anot necessarily a physician desire to submit written comments or in) authorized by the Commission to be a Suggestjona for conalderation in connec. Ocncral characteristics of radia. user of radioisotopes) shall be immedi. tion sith the propoacd amendmenta tion till and radioactive matertals. stely accessible. nhould acnd them to the Lecretary of the Physical, ehemical, and pharma. j Commhslon. Ua Atomic Energy Com. ceutncal charactertatica of each radio- 3. A new 135 33 la added to 10 CFR ' m13ston. Wanhtngton. D.C ,20545. Atten. pharmaceutical to be used Part 35 to read as follows: ' tion : Chtcf. Public Proceedings Biaff by Wibaste t Mathematics to the useandandcalculations measurement $3133 h *lE'* h""' ""d "P""' 'I *I' Aprl! 23.19T1 Coples of commenta cn " of
'**""*' }
the tesoposed amendmenta may be exam, radioactivity. Including units of Quantity ia) of radioactivity (curies, millieurles, Each licensee shall notify the Di-ined at the Commission's Public Docu. miemurtes) and unita of radiation done rector of the apprapriate Atomic Energy ment Room at 1717 H Btreet NW.. and radiation exposure, Commission Regulatory Operations Re. Washington, DC. tiv) 1 The Use of radiation instrumentation glonal Ofnce listed in Appendix D of 10 title of 10 CPR Part 35 la amended to read as follows; *%fedical for measurements and monitoring in. CPR Part 20 of the Commission's regula. unca of radioisotopea cluding operating procedures, calibration tions by telephone and telegraph of any (byproduct of instruments, and limitations of instru. misadministration of radlopharmaceuti. m a tc h al ) ." ments- cals or any mtandministratton of radia-
- 2. A new I 35 32 la added to 10 CPR tv) PrLiciples and practices of radta. tion from teletherapy and brachytherapy Part 35 to road am follows: tion protection n 35.32 I vi) AdditJons! training in the above within sources This nott'lcation shall be made f amlition. of licenses for med. 24 hours after such misadmints.
6ent u.e. of re.hmaotopes. subjects. as appropriate, when new dutles tration in known For the purpose of the tas are added. requirements of this acetton, misadmin-
'Ihe uner of radioisotopes in or (2) applied to humans for diagnostic, thera. 1stratton Assure that such technicians and tstration of: is defined to include the admin.
peutic, or investJgational purposes shall other paramedical personnel recette ap. (1) A radiopharmaceutical, or radta. be a phyniclan authorized by a condition proprinte retraining in the subjecta llated of a meneral license or a specific license, in parnaraph td) Il of this section to Lntended, including tion from a source other than the one a specifle license of broad maintain proftetency and to keep abreast (2) A radlopharmaceutical or radia. Acope. tamued by the Commission tau. of developments in the field of nuclest thortied physician)- medical technology. tion to the wrong patient, or
#bs No authortud physician may dele, (3) Keep recorda showing the bases (3) A dcse of a radiopharmaceutical, sate to persona who are not phystetana for such determinations of proper train. or exposure from a radiation source out.
under the supervision of the authorized ing,and side of the intended dose range presc,ribed phytician, the following: (4) Retain reaponalbility as 11eensee or by the physician or by a route of admin-i1) 'Ihe approval of procedures in. authertred user for the satisfactory per. the istration other Lt.an that intended by phyalcian, volving the administration to patienta of formance of such actirttles. rc.dlopharmaceuticala or the application ten Certification in nuclear medidne tb) (1) Whenever a misadministration technology by the American Registry of of a radiopharmaceutical or radiation from a teletherapy or brachytherapy 7todaAt sicaltte vot, as, peo. 4 Art: Day, se AaCH 9,1973 m me
, PR"PESED BULE CAKING 6101 source could cause a demonstrably ad- FEDERAL POW kRCOMMISSION n sub-verse effect on the patient to whom it gngill e suc,hyr
* [IS CFRPart 2] order in this proceet ,ng. De staff, in ita uth ph 1cla a pr p y IDonat No. W ,73 order 41M] discretion, may gra t or deny requests notify the patient or a responsible rela- APPLICANTS' ENVlf DNMENTAL REPORT 3 IOQOUI', ,p ',-d am ndmenta to Part 2 n unte n e a a o ai Proposed Propi raton GuideHnes of the Commission's generni rules woultt juds: ment such notification would be Mancu 2,1973. be lasned under th authority grantcd i
contrary to the best interests of the pa- Pursuant to 5 IB 2. 553, the Com- the Federal Power Ci mmission under the tient or a surviving relattve of the mission gives notice it proposes to amend Federal Power Act. articularly sections pauent. Part 2 of its gen. ra) 311 (2) It death occura af ter a judgment la guidelines for prep sa rules by addig 10654 101066, 15, 1068 307, 309'10'46d;and Blat. 312 798;(4149 Sta made try the physician that notification environmental repc ts .pursuant ton of applicants to Order StatI 839 840,84'1 8 2,843,844.856,857, to the patient nr n responalble relative of No. 41'rC, On De err ber 18,1972, the 858,859 860; 61 Sta . 501; 82 Stat. 617; the pntlent of the misadministration Commission tasued Or ter No. 41%c (37 16 U.S C 797 803 f )8, 825f 825h, 825; would tv contrary to the best interests FIL 28412 Dec. 23 1572), further pre- 825k),'and the Na'tt al cas'Act, partiel of the pnttent and the misadministration scribing regulationa fo.' the implementa- ularly sections 7 and l6 (52 Stat. 824. 825. muy have been a contributory cause of tion of the Nationa ,Eavironmental Pol- 830; $6 Stat 83,' 8 61 stat. 459; 15 the death, the licensee or the authorized icy Act of 1960 (8; 8 tat. 852) (NEPA), g g g 7g7o a id the National En-physician shall notify a responsible rela- and amending II : .60 tEl Policy Net of 1969 Public tive of the patient of the misadministra- the general rules (18 2.81 and 2.82 of [vi 0D"' CFR 2.8&2.82), 9v 'd January '1,1970, tion unless the physician maken an ad* l 4.41 of the regula Lions under the Fed- particularly section i 102 and 103 (83 ditional determination that much notifl- eral Power Act ( l8 CFR 4.41 ) . and stat. 853, 854). cation would be contrary to the best ll 157.7 and 157.14 a) of the regulations A" Interosta of a surviving relative of the under the Natura Ons Act (18 CFIL p ,,g 2 al P y d Interpreta-patient. 151.1 and 157.14(ati. tions. in subchapte : A-General Rules, ece in addition to the notification re* The current ener ty ettuation has spot. Chapter 1. Title 18 >f the Code of Fed-quired by parasraph ta) of this section, !!Ehted the need to ' srredy and creative eral Regulations as follows ,. each Itcensee shall make a report in writ- solution of envirol . mental problems in III Amend i 2.81 a so ing within 30 dayn to the Director of the sectors of the a rlergy industry regu, read ., R,wlatory Operations, U.S. Atomic lated by the Feders EncrR y Commission. Washington, D C. De Commission 1 !rtstes Power Cornmission. $ 2.81 Compliance .ith the National Fn. to provide as vironmental Poi ry Act of l%9 under 20545. with a copy to the Director of the much guidance as pos>1ble to those fil- Part I of the Fed 'ral Power Att. approprinte Resulatory Operations Re* ing applications u ider the procedures (a) All applicatfor s for major projects alonal Omcc specified in Appendix D of promulgated in Or 'er No. 415-C. These 10 CFR Part 20. of each misadmin!stra* guidelines are pros we 1 to be added in (those in excess of 1 000 horsepower > or Lion. The report requtred under this para
- the form of Appenc Lees to Part 2 of 'ntle for reservoirs only 1 roviding regulatory grnph need not include the name of the 18 CFR to supplema d H 2.81(a) and 2.82 flows to downstream (major) hydroelec-patient but shall describe the nature, ex- (at. Amendments s ,re hiso proposed for tric projects under I art I of the Federal ut. and enuse of the misadministration il 2.81(an and 2.8 (a) in order to add Power Act for liceni e or relicense, shall and the cortccuve nteps taken or planned the appropriate cri es references to the be accompan!cd by 4 thibit W, the appil-M nasure agatnat a recurrence. If the new guldettnes. cant's detailed repo t of environmental mtsadmintatration could cause a demon. We guidelines se ek 4 identtfy infor-factors specified in i i 2.80. 4.41, and Ap-pendis A of Part 2 of this chapter. All ap-strably adverse effret on the patient or if mation to be suppl led by applicants. to plications for surre tder or anlendment death occurs and the misadministration provide a basis for he areparation of an may have been a contributory cause of environmental rept -t prepared pursuant of a license propos ng construction, or the death, the report shall either confirm to gl 2.81(an and !82:as of the Com- operating change o a project shall be that the pntient or a responsible relative mission Regulation 5, aTd to provide an accompanied by the app!! cant's detailed of the patient has been notified of the insight into the sea pe >f environmental report of environme tal factors specified mteadmintatration as required by para
- reports required to tantre a balanced in' in 12.80 and Apper ilz A. Notice of all rrnph (c) all and 82) of this nection or terdinciplinary ann ysio of actions sig- such applicauons a kall continue to be nhnll state that nottftcation was not given nificantly affecting .he 2uality of the hu- made as prescribed by law, herame in the phystelan's judgment such man environment. Th guidelines will * * *
- not tnml non would be contrary to the best also asstat the C< mn tsalon's staff in (2) Amend ~ l 2.82 m) so that it will Intrants of the patient or a surviving massasing deficienc1 :s i 1 applicant's en. resd:
relative of the patient. If the patient ce vironmental report , in canes which in* $ 2.82 Compliance whh the National En-relative lg not notified the physician volve major Feder1 1a:tions. ,ironmental Pol y Art of 1969 under shall confirm that thlt decision was re* Any interested p 'rnot may submit to the Natural Gas let. viewed by a local Fthles committee or the Federal Power Commission. Wash. an equivalent group of peers and shall ington, D C. 20426 not later than April (a) All certificat i applJesuons filed state whether or not the committee or 12, 1973, data, vien i, cc mments, or aus. under section 7(c) of the Natural Gas group concurred with the decialon, gestions in writing i one trning all or part Act (15 U.S C,717f t 9 I for construction sale Any noufication or report filed of the arnendmer aproposed herein. of pipellne facilities except abbreviated with the Comm1Aston pursuant to para- Written tubmittals will be placed in the applications filed pt t uant to i 157.7# bs, ernphs #a s nnd #ct of thte section shall Comrnisaton's pubi c files and will be (c)'and (d) of this c bapter and producer i be prepared no that any details which available for publ F trspection at the applications for 2 s sale of gas filed would identify the patient will be stated Commission's OfBei of Public Informa- pursuant to ll !$7.2 l-29 of this charter, s in a separate part of the notification or tion, Washington, I. C.2D426. during reg- shall be accompani d by the applicant's report. ular business hours Ar1 original and 14 detailed report of khe environmental
#nec= si,1st. se stat. 938, 648, as amended: conformed copies at ould be filed with the 42 11a e sitI,2201) Secretary of the ( omnimainn Submit- factors specified in I!2.80 and Append!x to the Comre h should indicate E Nouce of all sm I appIlcauona shall Dated at Wanhington, D C., this 28th tals the name, title, mall ngiddress, and tele. continue to be ma i r as prescribed by day of February 1973 phone number of he l person to whom la w, For the Atomic Energy Commission. communications coi cerr ing the proposal . . . .
Patn, C. Dewesa, should be address < 1 aad whether the Secretary of the Commise6ovs, person filing them i equasts a conference (3) Append to la 074 Part 2 Oulde-at the Federal Powt r Cornmisalon to dis. Ilnes for Preparatic 1 of Environmental Irn Dne n 4446 Fued 3+n.s.48 ami cuas the proposed ri visicn. The Commis- Reports as follows: No. 46-l't.1-0 HDisAt stG15fts. VOL 38, NO. 4WelDaY. MasCM 9,19r3
E9.20 EtutES AND REGULAVIOMS PART 20-STAEAf:DS FOR PROTECTION radiation,or rad!ncti,e material are Accordingly/ pursuant to the Atomic AGAIN ST RADIATION specifled in i 19.13 >f th:s chapter. Energy Act of 1954, as arcended, the fol-(b) When a licer.see is required pur- losing amendments of 10 CFR Parts 31, Reports to 1:mt loyees and Other suant to il 20.405 J 20108 to report to 34,35,40,70,115 and 150 of the Commis-Iideiduals the Ccmmissicn ar :' ext osure of an in- ston's regulations are published as a The Atomic Enc) gy Commission pub
- dividual to radiatis li or radioactive rna- document subject to codification, to be lished a notice ;n Ihe FrcrRAr. rec! STER terial, the licensee hail al.so notify the efective on September 17. 1973.
on January 4,1)73 (38 FR 805) that it individual. Such rutice shall be trans-had under oon..ideration proposed mitted at a time PART ENERAL ICE S FOR not later than the amendments to 10 CFR Part 20 of the transmittal to the Cxntaission, and shall Commission's rc Ju ations. The amend
- comply with the p; i ' visions of i 13.13(a) 1. Paragraph (a) of I 31.2 of 10 CFR ments would t :21 sfer from 10 CFR of this chapter. Part J1 is amended to read as follows:
Part 20 certain ections that would . be incorporated in Lhe new 10 CFR Part pm tel, ca stat. M
,4: U.s c. :201) $ 31.2 Terms and conditions.
19 and would uh to 10 CFR Part 20 Dated at Cerrnar :cwn. Maryland, this (a) The general licenses provided in appropriate reftre;;ces to new 10 CFR 10th day of August L373. this part are subject to the provision of Part 19 so that the transferred provi. For th'e Atornic L ierm Cornmission. Il 30.14id). 30.348 a) to (e), 30.51 to sions could be eu. y found. A new sec- 30 63 and Parts 19, 20 and 36 of this tion would be ad J contaming the re- Goa: a t!. GRANr. chapter
- unICss Indicated otherwise in quirements for iohfication and reports tctag Secretary the language of the general license, to indhiduals w tich could include per- 4
'/ fe Commusion. . . . . . ,
sons other than mmlones. The require- g- 2. Subparagraph (7) of I 31.5(d) of oc.73-17080 F, ad as 16-73.s:45 aml ments for report 6ta indiv! duals as spec- 10 CFR Part 31 is amended to read as ified in ll 20.4m ) and 20.408 would f I; ws. be combined inta c ne paragraph of the MISCELLANEOUS AMENDMENTS TO new section. Int, re,ted persons were in. CHAPTUt g 31,3 Cert ain mca uring, gauging or sited to submit y ritten comment.s or Notice is hereby give" f the amend- "" # "8 *** suggestions for ( uraideration in connec* ment of 10 CFR Part $1. 31, 35, 40, 70, * * * *
- tion with the p:oposed amendments and 150 (d) Persons who own, receive, acquire, within 45 days oft ?r publ! cation of the 115'oncurren.tly with the publication of lxNess or use a device pursuant to the I C
notide of propo o rulemalung in the this notice, the Atomic Energy Commis- general Ucense contained in this section: Prora At. Hrcistri . sion is pub:ishing a nev part to it.s regu- . . . . . Af ter cor Id or of th cc 1
!ations.10 CFR Part 19 ,Etices. Instruc- (7) Shall be exempt from the require-the proposed an'et 'Iments. Pursuant to u m an s kers; Impec* ments of Parts 19 and 20 of this chapter, the Atomic En 'rty Act of 1951. as tj ns. Certain settom t tat fomgly ap. except that such persons sha!! con, ply amended, and sechons 552 and 553 of
[r fer d o1 C title 5 of the Un11cc States Code, the fo1* CFR Part.s 31,31. 35,40. 70,115, and 150, P 19. It 10 ' ' lowing amendmeTia to Title 10, Chapter references to 10 CFR P trt 20 are made. * * * *
- I, Code of Feden! Regulations, Part 20 The amendments whi' h follow add 10 $ 31,7 [ bnended) are published as a document subject to CFR Part 13 where ea' h reference to a 3. Paranaph @ of I 31.7 of 10 CFR 1 at on, to 1 e c!!cctise on Septem- transferred section of P) CPR Part 20 is Part 31 is amended by deleting "Part 20 Concurret$tly t t'h publication of this made- a rec m of this chapter" and substituting there-c.otice, the Aton a new 1 CI,Tt Part for " Parts 13 and 20 of this chapter".
ic Energy Ccmminion 13 provide options to w ikers concerning is pub!13hmg a :lew part to its regu!a- inspections of working conditions regu- 3 3M I T""'n ded ) ' tions,10 CFR Part 19 Notices, Instruc* lated by the Commbs.,n comparable to 4. Paragraph (c) of 131.8 of 10 CFR tions and Reporis to Workers: Inspec- those that are afforded for workinif con- Part 31 is amended by delettng "Part 20 tions, ditions regulated by t! e Department of of this (hapter" and substituting there.
- 1. Section 20 2 N is amended to read Labor pursuant to the Occupatton Safety for " Parts 13 and ::0 of this chapter".
as 1 llows: and IIealth Act of 19N. as set out in 23 5. Subparagraph (3) of I 31.10ib) of 10 9 20.206 In.orm tian of per.nnnel. Crn Part 1303. The acendmants to 10 CFR Part 31 is amended to read a.: CFit Parts 31, 35 an 140 w!uch follow f ollows: Instructions rmired for individuals exempt certain holdct s of general 11 working in or frerenting any portion of
* $ 31.10 Cencral licen=c for st rontiu m te ric ed a aJe spectned in i 13.12 'yC 1[ro FI ,
90 in lec detectie n deices. The amendment to 10 CFR Part 38 re-
$ 20.101 ( Delet 4 1 qulres licenws to pros de radiographers (bl Persons who own, receive. acqdre.
- 2. Section 20.4C6 is dc!cted. with copics of, and in. 'ruction in app!!- posseu, use or transfer strontium 00 con-cab!c rections of,10 C' il Part 13 aa well tained in Ice detection devices pursuant
$ 20.103 [Tmemlrill as 10 CFR Part 20. Tl o amendmenta to to the general license in paragraph (a)
- 3. Paragraph ni of I 20 405 is deleted. 10 CI'It Patts 70 and ! .0 subject ccitain of this section:
reneral licetaces und r those paita to . . . . .
$ 20.106 ( 1)<le t m I the prowtons of 10 CI 't Part 13 as we:1 (3) Arc exempt from the requirements
- 4. Section 20 4M 1.s deleted. aa to 10 CFit Pat t 20.1 te amendment to of Parts 19 and M of this chapter except II I '# ,'i g er o thor g g g g
$ 20.In3 ( bnr Adl g ,
g
- 5. Section 20.4 M is amended to d(lete owned nucIcar re.etot : to the prosistans provbles of Il 20 301,20.102, and 20.403 the words "to suel ndividual and". of 10 Crit Part 19 a wc!! as 10 CFR of this chapter.
- 6. A new I20 1: ) is adJed to read as Part 20. . . . . .
follows: Unauw tW rm ndanu relate 4 31.11 ( Amendid] rotely to clatificauon and conshtency
- O20.109 Ltifiu ion s and trports to with existmg regulati nu, the Ccmmu- c. Paragraph (f) of l 31.11 of 10 CFR indi iduals. slon has found that n atice of proposed Part 31 is amended by deleting "Part 20 (a) llequiremc3 :s for nottacations rulemaking and public procedure therecn of this chaptcr" and substituting there.
and reports to inh.tduals of cxposure to are unneces.sas y. for ' Parts 13 and 20 of this chapter". Ft:ltAt stClitta g VOL 38, NO. I M413AY, ALOW 17,1913
e
- P RT 34-LTFNSES FOR RADIOGRAPHY $ 130 2f) Ita*o:nhion s.f AND RADIATION SAFETY REQUmE- Agreement aiate litcme.. D. C!rrif!M that brdix A of Part t5 MENTS FOR RADIOGRAPHIC OPERA. Is applicab:e to rc< ua!!ncation prograrm NS for operators and .cntor cperators of all (bI Notwithstand$ng mty provision to production and ut :iration facit:cs:
- 7. Subparagraph (3) of I 31.31(a) of the contrary in any spect'.: license issued b. Specifies that uithin thrce months 10 CFR 38 is amended to read as follottst by an Acrecment State N a person who af ter t.ouance ofa i o;)cratm't bcense
$ 31.31 Limitatium* cnCaces in activit!cs in a 3.on-Acrectneng fact ity licensec s! all have in op:ratien (a) The licenice shall not pcimit anY State under a generallict me provided UJ an opciator requr Scation prorram:
person to act as a radio';rapher until this section the general ircuuc prosided c. Provides that notw:thstandmg the such person: in this section is subfc t to the provl. provuicns of I 50 ' O. the hct nsee t h:J.1
. . . . . slons of li 30.14 ads. 30.3 8, and 30.51 to not, except as spe .tically autho:ved by 30.03 inclusive of Part 30 cf this chapter; the Commission.
(2) }fas received copies of and instrue. !! 40 41, 40.01 to 40.63 mclusive, 40.71 anproved operato 1 :ake : a chance in t.n requahfcat2on pro-tion in the regulations contained in this and 40 81 of Part 40 cf t!..s chapter; and grara by which tl > scope, time a!!ott,:d part and in the app!! cab:0 sections of !! 70.32, 70 51 to 70.5G mclusive. 70.61 for the program or f requency in conduct. Parts 19 and 20 of this chapter. AEC 70 C2, and 70.71 of Part M of this chap. in; diacrcnt puts of the program is de-11 cense (s), and the !!ccnscc's operatm, ter; and to the provision of Parts 10. 20 cicased; and and emergency procedurcs, and shaEl 71, and Sub;) art B of Part 34 of this d. Requires b :!ders of cperating have of; anddemonstrated understanding there. chapter. In addition any person who en. !! censes in cPet o : the cacettre date of ga:;es in activatics in hon-Agreement these amendmento to submit an opera.
' *
- States under a general hcense provided tor requahfication >rogram fer Commis-in this section: slon approval anc concurrently imple-
- ment that prograrl within threc months PART 35-HUM f US OF DYPRODUCT M 1ct,ca s t 048; 42 US c.2201) "
n
$ 3S.31 [ Amended] Dated at Germantown. Maryland this 3. Section 55 31 ,' has been revised to
- 8. Paragraph (e) of I 35 31 cf 10 CFR 10th day of August,1973. require a licensee, u ho has not, for any Part 35 is amended by deleting "Part 20 For the Atomic Enerf y Commission, reason. been act$cly perfonnini the of this chapter" uld substituting there- functions of an terr. tor or a senior for " Parts 19 and 20 of this chapter". Oonox 71. Ga4xt, operator for a pern! of four rnonths or Acf mo Secrcfcry lon':cr, to demons 1 : ate to the Commis-q/ the Commission. slon that his know cd:e and unden. tars PART 40-LICENSING OF SOURCE tra Dd3-17c82 rded &1c-73,8:45 am) ing of facility opention and admhustrr.-
MATERIAL 9 ti n are satisfactoly before resuming ht 8 40.22 [ A mended] heensed duties as :n operator or a senier ART 5%LICENSl$ Of PRODUCTION operaWr.
- 9. Paragraph (b) of f 40 2 of 10 CFR AND UTILIZATip FACILITIES Part 4014 amended by delettn; "Part 20 4. Section 55.33 has been reviscd to of this chapter" and substitutm'; there- PART 55-OPERA 10RY LICENSES permit the submisdon to the Commissicn fcr " Parts 19 and 20 of tius chapter"- R aEcation Requlr m nts for Operat. within m an applicatlon for licen:o rene< val filed tno years o!ter tl.c cf!cethe date ing Facilit;es tion Personnel of Ptmfuction and Utttua. of these amendmetts a statement as to PART 7hSPECIAL NUCLEAR MATERfAl.
4 partial comp!ctior - of a requahncaNn 8 70,19 [ Amended) On June 14.1972. Commiss!on pubhs> the Atem!c Energy progrr.m in cases were an orert.Wr has 1 n' the PtatRAt. not Completed the (ntire frogram at the
- 10. Paragraph (c) of f 70.19 cf 10 CFn Rectsttn (37 FR 1176 a f or pubhc com. time of heense re icwal t'ccause of the Part 10 is amended b) delettn; "Part 20 ment propcud amenc mNts to 10 CI n time nccessary fo/ the facihty hectuce of ti,}is chapter" and substitutine there. Part $5, Operators' Lic:n's. u hich w ould to implement thc I rcqualineation pro-for Parts 19 and 20 of this chapter". (ti provide for the uN of requahncation cram prescribed in (hc amendments. The pro:: rams for operatm; personnel as a operatcr ni!! be rquired to submit a PART ll5-PROCEDURES FO't REVIEW tabush minimum conditicn of Ilcensereqteact 31 and (2) es. statemcut coverin; thor,e portions of the 21rr ments for re. recuahncation pro ~am u h!ch have tcen OF CERTAIN NUCLEAR REACTORS EX. quahncation pro ranu tor production completed as of the EMPTED FROM LICENSING REQUIRE. and utthzation f acihty date of the app.lca.
MENTS >pera tors and scn. tica. ! tot opcrators.
- 5. A new Sectio t 1 entit!cd, "Sched.
- 11. Paragraph (b) of I !!5 O of 10 All interested persons nere invitcJ to ule." has been add 'd to Appendix A and C R Part 115 is amend (d to read as sutmit ecmments or suc,+stions in con. entmg Sections I through 5 of Ap.
0 * *
- nection with the prop 'l amendments pendix A have tecn renumbered 2 within C0 days af ter i m ut heat;on of the throu'h 6. respec:hely. New Section 1 8 113.30 tion , Applical,ilhy of cihcr regula. notice of proposed rue'nakmg in the requires t!:e requahncation pro: cam to Fcerrat. Rtcista n. Af ter e arclul censid. be conducted for a cration of the commcr t.s recetted in re. to cxeced two year contmuous period not (b) Each ho Jcr of an authorizat!cn sponte to the notice i and upon conclusion shall comply w Ath the provhions of Parts Inakm: and other foe of proposed rule. to be promptly follm.cd by successive re.
.or s invohed the quahtication progt Lms.
19 and 20 of this chapter to the same Ccmnussion has detiud to adopt the 6 Scction 2 of extent as !! such authorization ucre a amendments in the ic 'm set out below. ,, Lectures ,has bCoaApocndat A entitled, rtvised to: g3 cense issued under Part 50 of this The amendm(nts as ado' tcd scMect the A. Permit the us chapter, su::cstions in a num me: of the com, examination civco Ptoofcach an annual wrliten operatcr or ments. The prmeipal <hanges from the senibr operator to form the bas!s for the ptoposed amendments ar.* as fol ows: lecture teries. Orly arcas where im.
- 1. A new I 50 341b) o > has been added proved know cd;e is required of an op.
PART 150-EXEMPTIONS AND CONTIN. which rtquires that ca, h wphcation for erator need be cc UED RECULATORY AUTHORITY IN a heense to operate a tcred in the lecture AGREEMENT STATES UNDER SECTION desenption and plans W thty include a series; 274 ter implement 2* Livn of an operator req uihn b. Permit the uso of traitung alds such
- 32. De prefatory languacc of para- gram uldch. as a r un num, cation p+
meets the as films and videote s;and graph (b) of i 150 20 of 10 CTR Part requirements of Ap cru!.e A of Part 5. c. Encourage inib51 dual study on the
- 2. A new 150.541 -11 tas been added part of each oper tor, but provide that 150 is amended to read as follows: which:
A requahncation rogram based solely flott At 38C15f t8, Vol. 38, NO.139.-4tl0AY, AUCulf 17,1973
>gm PROPO$tD RUtt$
and wou$d establish three new groups of medical uses of radtotsotopes as follows:
. Group nl. Use of generators and asagent kits for the preparation and use of redlopharmaceuticals containing by-product material for certain diagnostic G8es.
Group IF. Use of prepared radiophar. maceuticals for certain therapeutic uses. and Group F. Use of sources and devlees containing byproduct material for cer-tain medical uses. Under this proposed expansion of group licensing. physicians and medical insti-tutions would be 11eensed to use the by-product materials for the medical uses designated in one or more of the groups for which the applicant has appropri-ste factllties, equipment, operating pro-cedures and trained personnel (both physicians and parsmedicalI to perform the medical procedures and handle the radioisotopes deatsnated in the group or groups. We groups of licensed uses would be amended from time to time to add new radiopharmaceuticals, sources, deytees, and uses as they are developed. This would authorize automatically the new uses and materials for persons licensed to perform the uses specified in the group or groups without the need for filing an application and reaciving a 11-conae amendment. In addition to the publicauon of such amendments in the Freensa Racrstra, nottees of addt-tions to the groups would be mailed to all medical licensees of the Commission. [20 CFR ParteO 22 d asi versons usi#- raoionharmaceuticais. GROUP UCENSING FOR CUtTAIN renerators and reagent kits containing RAEDICAR. USES byproduct materials or sources and de-vices, under the licensed groups would be Neues of W % required to obtain such products from he Atomic Energy Commiselon has manufacturere licenstd by the Commis-under consideration amendments to its alon pursuant to il 32.72. 32.73 or 32 74 regulations in 10 CPR Farts 31,33. and respectively, or by an Agreement State 33 to expand its licensing of groups of pursuant to equivalent Agreement state medical uses of byproduct material regulations. Although the . Commission which have almtlar requirements for does not regulate the manufacture and licensee quellfications, to specify licens* distribution of reagent kits which do not ing requirements for the distribution of contain radioactive;naterial it does reg-byproduct material to such !!censees and ulate the use of such reagent kita for the to add new byproduct material to the preparation of radiopharmaceuticals by general license for certain la vitro clin. 11censece of the Commission as part of Ita leal and laboratory testing. licensing and regulation of the users of In 1967 the Comminston added il 35.14 the byproduct material. Users of such and 35.100 to its regulations in 10 CFR reagent kits to prepare radiopharmaceu. Part 35 to simplify its procedures for Ltcats pursuant to a Group UI lleense licensing certain diagnostic uses of would be required to use reagent kits radioisotopes. Under these secuone a which are approved by the Commission number of the more common diagnostic or by an Agreement state. Manufactur-uses were divided into two groups on the ers of such reagent kits who desire to be6sts of similar requirements for user have their reagent kits approved by the traintng and experience, fact 11tles and Commisalon for use by Group III 11-equipment, and radtauon safety proce- censees would be permitted to submit dures. Group I included diagnosuc uses the pertinent information specifled in characterised as uptake, diluuon. and i 33.73 for Commission consideration. escretion studies. Group U candated of In the exerctae of the Commiraton's acanning (now called imaging) and regulatory program, licensing of the use tumoe taraltamuon studies. Under the of rad.opharmaceutleals has included procedures set out in 6 35.14. an app 11* considerations of patient safety and drug cauon for a specific license for a diag
- effectiveness. 'this procedure has been nostic use of byproduct material spec 18ed followed since the Food and Drug Ad-
. In Oroup I or Group U ts considered bF ministration (FDAl regulations. 31 CFR the Commission as an applicauon for 130 3. New Drugs for tnvesusational Use all of the uses within the group, in Human Beings, which were issued in De manandnwte proposed berein 1963 contained an esemption from those would add some diagnostic uses to regulations for radiopharmaceuticals Oroupe I and U of I 35.100 Schedule A which are regulated by the AEC and pesetAt te64ffte, VOL. 39, NO.14.-Js0H0AY, JAleWARY 38,19r4
PROPOSED RULES 2385 k. Agreement States. The Chairman of the Secuon 31.11 of 10 CFR Part St. which maceutical manufactured in the form to Commission, in a letter to the Depart- provides a general licanae to physiciana. be admtalatered to the patient, labeled. ment of Health, Education, and Welfare cunica! 1aboratories and hospitals for use pachased, and distributed in accordance commenting on their proposal to grant' of certain radioisotopes for in vitro cuni- w!th a specific licenae lasued by the Com-that exemption, expressed the view that cal or laboratory testing, would be miasion pursuant to 132.72 of this chap- p eventually an appropriate balance with amended to add hydrogen 3 (trittum) ter or in accordance with a specific 11 respect to the regulation of drugs con- and iron 69 to the general licanae, Sec- cense tasued to the manufacturer by an taining byproduct material would involve tion 32.71 of 10 CFR Part 32 would be Agreement State pursuant to equivalent j PDA regulattens controlling the pharma- amended to add these isotopes to the State rsaulations. ceutical quality of drugs and the safety provtstons for 11oenalns thair manufac. (2) For Group IU, no licensee shall and emency of drugs utth respect to the ture and distributton for in vitro use receive, possess, or use generators or patient, while AEC regulatory contola under the generallicense. reagent kita conta!ning byproduct ma-would govern radiation safety of em, Pursuant to the Atomic Energy Act of terial except generators or reagent kits playees and the pubile during manufac- 1954, se amended, and section 653 of which are manufactured, labeled, pack. ture and use of the drugs. t!ta 5 of the United States Code, notice aged, and distributed in accordance with The Commteston and the FDA are co- is l'ereby given that adoption of the fo!- a specific license lasued by the Commis-ordinating their respective regulatory Iswing anandments to 10 CFR Parta 31. sion pursuant to $ 32.73 of this chapter programs to provide for a transition fmm 32, and 35 la cetemplated. All interested or In accordance ulth a specific license the Commlnton to the FDA of the regu. persons who desire to submit written issued to the manufacturer by an Agree. lation of pharmaceutical qua!!ty, safety ccmments or suggestuna for conaldera- ment State pursuant to equivalent State and emen y of radforharmaceuucals in tion in connection with the proposed regulations and no licensee shall use re. such manner e to mintmtre dup!! cation amendments should send them to the agent kits which do not contain byprod-of regulatory activittes. to accomplish the Secretary of the Commission, UE, Atomic uct material to prepare radiophsrmaceu. objectives of protect'ns putlic health Energy Commisalon, Washington, D C, ticals containing byproduct material ex-and safety with9ut unduly inhtt;iting the 20545. Attention: Chlef, Public Proceed- cept reagent kits which are arproved by use of radioactive materials in medicine ings Staff, by March 7,1974. Copies of the Commission or by ,*n Arreement and to assure no dieruotton in the sup- comments received on the proposed State f'r use by persens !!cenrrd rursu-ply of these drugs which are of vitalim- amendments may be examined at the ant to LW I 3514 and Group III of portance in many medteal applications Commission's Public Document room at Schedule A,l;5100,or equivalent Agree-during tho tran.ithn r'eriod 1717 H 8treet NW., Wawshington, D.C. ment State regulauna. On November 3,1971, the FDA pub. 1. Section 35.14 of 10 CFR Part 35 is (36 For Group V, na licensee shall re. Itshed in the Freenst Rectstra (36 FR an ended to read as fo!!ows: celve, possess, or use bypsortuct materm! 21026) a notice of termina11on, effective execpt as contamed in a souro or device December 2,1971, of the exemption from 6 35. Sp la i f al which has been manufactured,13beled. FDA investtrational new drug regula. gg* pacitaged, and distributed in accordare tions for AICC and Agreement State regu. with a specific license issued by the Com. lated radiopharmaceuttents for well (a) Subject to the provisions of para
- mission pursuant to I 32.74 of this chan. '
established uses and provided for regu. graphs (bl. (c), and (d) of this section, ter or Ln accordance with a spt'effic 11 Intion by the FDA of such radiopharma. an application for a specifle 11 cense put* cense lasued to the manufacturer by an ceuticals (21 CFR 130 49-Regatrementa suant to i 35.!!,6 35.12, or i 3513 for any Agreement state pursuant to equtvalent regarding certain radioactive drugs ) It medical use or uses of byproduct material State regulations. ' b expected that the FDA will similarly specified in one or more of Oroups 1 to (4) For the investigational uses in I terminate the exemptfon for radiophar. V, inclustre, of I 35.100 will be approved ll 35,100tal Group I (19)(b) Group 11 maceutleah for investigational uses at for all of the uses within the group or (25), (c) Group illt 3), and (d) Group lV an early date, groups which include the use or uses spe. <gi, the 11rensee shall, prior to the use The groups of uses in 6 35100 would cified in the spplication tf: of each different type of investigational include medical uses of redlor harmaceu. I1) The applicant satisfles the require
- radiopharmaceutical, or generator or re-ticals for thich enfet, and effectiveneas ments of l 35 tl l 3512,or l 35.13; agent hit for the preparation and medi.
have been established and thone which (2) ne applicant, or the physician cal use of investigational radlophstma-are underFotng invetttration to estab. designated in the application na the indl* ceuticals, and prior to use of sm h itsh auch safety and effectiveness. For the vidual user, has adequate clinical erpert* investigational redlopharmscaut t sal, inveattrattonal redlorharmnecuticals and ence in the types of uses included in generator or reagent klt obtained fr,m uses included in the lleensed groups, a 11 the group or groups: each different supplier, file Form AEC. censee aou'd be required to register with (3) The applicant or the physletans. ....... " Registration Certificate-Medi. the Comm!wton prMr to use of each dif. technologista, radiological safety person
- cal Use of Investigational Radlopharma.
ferrnt type of Investigationa! use to iden. pel and other paramedleal personnel who ceutical Under Group License," with the tift the radiopharmaceutteal,its intended will use the byproduct material have ade* Materials Branch, Directorate of Licens. purpose, and the surptier, and to certify cuate training and expertence in the ing UB. Atomic EnJrgy Commisslun, that he would be using the redlopharma. handling of radioactive matertal appro- Washington, D C. 20545, and receive ceutical pursuant to a "Nottee of Claimed priate to the unes included in the group or from the Commisalon a validated copy of Investigational Exemption for a New groups: the Form AEC ...... with registration i Drue" (IND) that has been accepted by (4) ne appilcant's radiation detecuon number easigned. De licenace shall fur. I d the FDA, and measuring instrumentauon la ade* niah on Forno AEC ...... the follosms The f.ew ll 32.72 and 32.73 which con. quate for conducting the geocedures in* informathn as ma, be required by that tain criterta for licensteg the distribu. volved in the uses, included in the grougs form: tion of radtopharmaceuticals, and gen. oc groups: (D Name, addrena and licenae number erstors and ressent kita for preparation 48) The applicant's radiation safety of thelicensee; of radiopharmaceuticals, to group use 11 operating grocedures are adequate for t1D Name of the radiopharruaceutical, censees would require manufacturers to handling and disposal of the radioattire generator, or ressent kit to be used; ' furnish evidence that the redlopharma. material involved in the uses included titD The radionuellde, chemical form, ceuticals, generators and reagent kits will in me group or groups. be manufactured. packaged, and la. (b) Any licensee who is authoriaod N and proposed ceutical useorofprepared to be used the radiopharma. and usedl l teled under an effective New Drug Ap. use byproduct material pursuant to one fiv) Name of the manufacturer of the pliention from FDA, a Bioloste Product or more groups in ll 35.14tal and 35.100 redlopharmaceuucal, generator or re. License from PDA, or a Mottee of is s' abject to the following condttsons: agent klt to be used; l Claimed Invesusstional Exemption for (1) For Groups !, II,'and IV, no ticen* tv) Certification that he has in his a New Drug" that has been aseepted by see shall receive, posseen, or use by* posesealon, and wul fouow, a copy of the FDA. product material sacept as a radiophar. gnan of inveausstlan ouutned in the "No. peossat 90013798, YOL. 39, NO.14-JsONDAY, JANUARY St,1974
,, No thPt.I-7
5- - _. . _ _ _m. .. - -~ 2386 PROPOSED RULES tace of Claimed Investigauonal Esemp. nated and repaired or to be disposed of (1) Iodine 131 as sodium todide uon for a New Drus* (IND) which has in accordance with Ca==t=aan regula. (NaI") for measumment of thyroid been accepted by the Pbod and Drug taces. A report shan be filed within 5 days uptake; Administration (FDA), of the test with the appropriate Atomie (2) Iodine 138 as sodium lodide ~; The Commission will not validate a Energy Ca-genton Regulatory Opers. (NaI'*) for measurement of thyroid ' Form AEC ...... until it has confirma. tions Regional OfBee 11sted in Appendia uptake; : tion from FDA that the resistrant is an D of Part 30 of this chapter, describing (3) Iodine 131 as lodinated human idenufled investigator in the IND or has the equipment tavolved, the test resulte, serum albumin (IHSA) for determina. otherwise been accepted by FDA se a and the corrective action taken) uona of blood and blood plasma volume; participant in the investigation. Itv) The radiation safety and handling (4) Iodine 126 as todinated human (5) Any licensee using invesugational instructions approved by the Atomic En. serum albumin (DISA) for determina. pharmaceuticals who is required to file erry Commisalon furnished by the manu. tions of blood and blood plasma volume; Form AEC ....... "Resistrauon Certif. facturer on the label attached to the (5) Iodine 131 as labeled rose bengal icite-Medical Use of Invesusational source. devloe or permanent container forliver funcuon studies; R:diopharmaceutical Under Group IJ. thereof. or in the leaflet or brochure (6) Iodine 125 as labeled rose bengal cense." pursuant to paragraph (b)(4) of which accompanies the source or device, forliver funcuon studies; this section shall report in duplicate to are followed and that such instructions (7) Iodine 131 as labeled fats or fatty th2 M:terials Branch any changes in the are maintained in a legible and convent. acida for fat absorption studies; information fumished by him in the ently available form; (8) Icdtne 125 as labeled fats or fatty "Tieststration Certificate-Medical Use iv) A quarterly physical Inventory la acida for fat absorption studies; cf Investigational Radiopharmaceutical conducted to account for all sources and (9) Iodine 131 as labeled lodopyracet, Under Group License," Form AEC...... devices received and possessed. Records sodlum todohippurate, sodium diatri. The report shall be submitted within 10 of the inventories shall be maintained zonte distrizoate methylglucamine, so. d:ys after the effecuve date of such for inspection by the Commisalon and dfum d!protrizoate, sodlum acetrimonte. chinse. shall include the quantitles and kinds or sodium lothalamate for kidney func. (6) For Group III, any licensee who of byproduct material,locauon of sources uon studies; uses senerators or reagent kits shall fol. and devices, and the date of the (10) Iodine 125 as labeled lodopyracet, loir the instructions for eluting the gen. Inventory; sodlum todohlppurate, sodium diatri. erator or processing radloacuve material 8 vt) Needles or standard medical ap. zoate, diattir.oate methylglucamine, so. with the reagent kit which are approved pilestor cella containing cobalt 60 as d!um dlprotttzoate, sodium acetrizoate. by the Atomic Znergy Commission or an wire shall not be opened by the licensee or sodium lothalamate for kidney func. Aarciment State and are furnished by unless specifteally authorised by a con. tion studies; j the manufacturer on the label attached dition of a license issued to him by the (11) Cobalt 58 as labeled cyanocobald to cr in the leaflet or brochure which ac. Atomic Energy Commission; min for intestinal absorption studies; companies the generator or reagent kit. I vill Patients containing cobalt 80, (12) Cot:Ist 60 as labeled cyanocobale (7) For Group IV, any licensee whor ceslum 137 and/or tr!dlum 192 Implants min for intestinal absorption studies; j possesses and uses radiopharmaceuticals shau remain hospitalised unut the im. (13) Chromium 51 as sodlum cham. for therapy shall usure that patients plants are removed. ate for determinations of red blood cell I cont:Ining mere than 8 millicuries of (c) Any licensee who is licensed pur. volurne and studies of red blood cell sur. todtn2131 for the treatment of thyroid suant to paragraph f a) of this section vival time; carcinoma or patients containing more for one or more of the medical use (141. Chromium 31 as labeled human thin 23 mit!!curtes of sold 198 shall be groupe in i 35.100 also is authortsed to serum albumin for gastrointestinal pro.
- k hospitalized use byproduct material under the gen. tein toss atudies;
- 88) For Group V, any licensee who eral l! cense ln 131.ll of this chapter for (IS) Iron 53 as chloride, citrate, or
.vmesses and uses sources or devices the specifled in vitro uses without filing sulfate for tron turnover studies; containing byproduct material shall as. Form AEC-483 as required by l 31.11 816) Potassium 42 as chloride for po.
sura thm.. b): Prot
- fed, nat the licensee is sub. taasium space determinations; ein Each cource or detice containing ject to the otlier provisions of l 31.11. (17) Bodium 24 as chloride for sodium mors than 100 eMerocuries of byproduct idi Any licensee who is licensed pur.. space determinations; mrtertil with a hWf life greater than suant to paragraph f at of this section' (18) Xenon t33 as sas. frec or in solu.
thirty days, except kidium 192 seeds en. for one or more of the medical use tion, in prepackaged individual doses cased in nylon ribbon, sha;l be tested groups in i 35100 also is authorized to only, for blood flow and pulmonary func. for c:ntamination and/or leakaas et in. receive, possess, and use for calibrauon 4100 studies; t:rv ls not to exceed sts months; an6 e and reference standards any byproduct (19) Any byptoduct material in a j rouret or 'evice shall be so tested prior to a:alertal with an atomic number not radiopharmaceutical and for a diagnostic its fit.". ue un! css the supplied furnishes hishse 'han 83 in amounts not to exceed use involving mesturements of uptake. ! a ctrtifftate that the source or device has 15 millicuhe total of materials with dilution, or escretion for which a No. bern so tested within sts months prior to half Uves not a.reer than seven days tice of Claimed Investigational Exemp. ] the transfer; and not to encoed ad microcuries total uon for a New Drus IINDI has been t ill The tent required by paragraph of materials with half lives longer than accepted by the Food and Drug Admints. I Cl(8) til of this section shall be capable seven days. tration (FDA)! Provided, nat the rests. I of d:tecting the presence of 0.005 micro
- 2. Section 38.100 of 10 CFR Part g tration requirements of I 35.14 t b) 44 ) are curte of radioactive material on the test is amended by changing the utle and ' emptied with, sampli The test sample shall be taken subuuss, by adding certain new uses to (b) Deosp fl. Use of prepared radio.
from the source or from the surfaces of the present parastaphs f a) Oroup I and pharmaceuuaals for dissnostic studies th) device in whleh the source la per* th) Oroup II, and by adding new para, involving imasu g and tumor localiza. m:mntly or semipermanenur mounted graphs (c) Oroup III (d) Orcup IV and tions, or at: red on which one might expect con
- to) Group V. De se (1) fodine 131 as sodium lodido f ar taminition to accumulate. Records of will read as fouows. cuen, as amendtJ. Ulyrold imagins; lent test results shall be kept in units of (2) Iodine 131 as lodinated human microcurtes and maintained for inspec. l 35.100 Selwdale A.-Ceaups of ami4 serum albumin (IHSA) for brain tumor tion by the Commission; cal esW bypnidert meWal. localtsauons and cardiac imaetns; tiill If the test required by paragraph (a) Group 1. Use of prepared radio. 43) todine 131 as lodinated human Ibi d8)til of this section teveala the pre. pharmaceuticals for certain diagnostle serum albumin IIMSA) for cistemos.
sene3 cf 0 005 microcurie or more of re. studies involving mencurements of up. raphy; movable contaminadon, tho ucensee shall take, diluuon and eservuon. This group Ett Iodine 131 as macroneeregated immedi:tely withdraw the souree fross does not include usse involving haastag lodinated human serum albumin for lung use and shall cause it to be decontaasi. and tumerlaadt==uona. Imasing; (. l MoteAt stellt98, Vot. 39, is0.14--AseseAY, JAsafARY SI,1914 ~
- m
o . PROSO$50 SULES 2:N7 (5) Iodine 131 as colloidal nnterung. (D sulfur colloid for liver and spleen 3. Sec 31 1 of 10 CFR Part 31 to e gregated) todinated human aerum ab imastig; amended b ins new paragraphs bumin forl19er imaging: (II) Iran.aanortlate-diethylenetria. (a)(4) and (5), by amending the first (6) Iodine 131 as labeled rose bengal mine pentamostle acid comptes for kid. sentence of paragraph (b), and by for liver imaging; ney tmaging: amending paragraphs (c)(1) and (di e 1I (7) Iodine 131 as todopyracet, sodham (till Diethylenetriamine pentancelle to read as follows: todohlppurate, sodlum distrizonte, trtzoate methylglucamine, sodium dipeo. futetion dia. acid (as) for kidney leastng and htney g g* g studies: trizoate, or sodlum acetrizoate for kidney , j,*I,, ,'g]', ,'[ [ f (17) Diethylenetrtamine pontaacette clinical or laimratory testing, ' imaging: acid (Sn) for brain imaging; (8) Iodine 131 as modium lodapamide (a) A general license is hereby issued (v) Human serum albumin micro. i for cardiac imaging; spheres for lung imaging; to any physician, citnical laboratory or (9) Iodtne 131 as lodinated human se. (vi) Polyphcaphates for bone imaging: hospital to. receive, acou're, possen, rum albumin (IIISA) for placenta local. (vil) Macroeggregated hutaan serum transfer, or use, for any of the fo!! awing tzation; albianin for tung imaging; stated tests, in accordance with the pro. f (10) Chromium S1 as sodlum chromate (vtill Disodlum etJdronate for bone visions of paragrarha sbt, (c), (dl, (el, . for spleen imaging; tmaging. and (f) of this section, the folloatng by. t till Chromium 51 as labeled human (31 Any generator or reagent kit' for product materials in prepackaged units: scrum albumin for placenta localization; preparation and diagnostic use of radio. * * * * * (126 Gold 198 in ec!!odla! form for pharmaceutical containing byproduct (48 !!ydrogen 3 Ittttlumn. In units hver ignaging; material for which generatar or rennent not exceeding 50 m!crocuries each for (13) Mercury 197 as labeled chlor. kit a
- Notice of Claimed Investigational use in in yttro clinical or laboratory tests !
merodrin for kidno/ an.d brain tmaging: Exemption for a New Drug" (IND) has not involving Internal or external ad. i a148 h!ercury 203 as labeled chlormer. been accepted by the Food and Drug Ad. ministration of byproduct material, or odrin for brain imaging: ministration (FDA1: Prorkfed, That the the radiation therefrom, to human be. < l ' (15) Selentum 73 u labeled seleno. resistration requirements of paragraph ings or animals, methlontne for pancreas imaging: 34.14(b)14) are complied with. i5) Iron 59, in units not exceeding 20 (16) Strontium 85 as nitrate or chlo. Idi Group IV. Use of prepared radio. microcuries each for use in in 5ttro ride for bone imaging in patients with pharmaceuticals for certain therapeutic clinical or laboratory te?ts not involvire auspected or dlagnosed cancer; uses. internal or external adminlitration of (17) Technetlum 99m as pertechne. <!) Oold 198 as colloid for Intracavg. byproduct materts!, or the radiation tcte for brain imaging: tary therapy of malignant effusions: therefrom. to human beings or antmmb, 4188 Technetium 99m as pertechne. (2) Gold 198 as colloid for interstlual (b) No person shall receive. acrpitre.
- tate for thyroid imaging; therapy of cancer; posess, use, or tratufer byproduct mm.
(191 Te:hnetium 99m as pertechne. (3) Iodina 131 as todide for therapy of terial pursuant to the general license late for mallvary gland imaging; hyperthyroidism and angina pectorts; estabitshed by parseraph (a) of this &c. (20) Technetium 99m as pertechna. (4) Iodine 131 as todide for therapy of tion until he has filed Form AEC-481, tate for blood pool imaging other than thyroid ca rcinoma: "Tlegistration Certificate-In Vitro Test. placenta locattration: (5) Phosphorm 32 as soluble phosphate Ing with Byproduct hf aterist Under Gen. , (21) Technettum 99m as pertechne- for therapy of polycythemia vera; eral License", alth the afaterials Branch. ( t&te for placenta localization; 461 F Mosphorus 32 as soluble phosphate Directorate of Licensing, U S. Atomic
#22) Technetium 99m as tabeled sulfur for thrapy of leukemia and bone Energy Commlulon, Washington, D C.
colhtd for liver ard sp!cen imaging; metastases 20$45, and received from the Commission
#23) Technettum 99m as labeled mac. (7) Phosphorus 32 as colloidal chromic a validated copy of Form AEC-483 wtth roaggregated human scrum albumin for phosphate for intracavitary therapy of registration number anstaned or until he lung Imaging; malignant effusions; has been authortred pursuans to i 3514
- s24) Xenon 133 as gas free or in solu. (8) Phosphorus 32 as colloidal chromic (en of this chapter to use byproduct mu l tion, in prepackaged Individual doses phosphate for interstitfal therapy of terial under the general liceme frt tids only, for heart and lung imaging
cancer: 11. * * *
#2$1 Any byproduct matertal in a ra. (9) Any tgproduct materialin a radio. I 31'l te A prrson who receive *, acquire 9 diopharmaceutical and for a diagnostle pharmaceuttral and for a therapeutie tue ruseves, or uses byproduct materi,1 use involving imaging for which a "Nottee fus which a " Notice of C!almed Invests. pursuant to the general license estab.
of Claimed investigational Exemption satio la! Exemption for a New Drug hshed by parasraph est of this section for a New Drus** (IND) has been me. (IND) has been accepted by the Food and shall enmply with the following: a lI 'the cepted by the Food and Drug Admtntstra. Drug Administration tP'DA); l'mrided, generalI censee shall not pouena at any tion 1FDA). f*rovided. That the regts. That the registration requirements of one ttme. pursuant to the general license tration requirements of l 3514f b)(4) are 135.14fb) til are comp!!cd with. In paragraph f al of this section, at any' com plied with. (e) Group V. Use of sources and de. one location of stornae or une a tot 4l , i ct Group 111. Use of tenerators and vices conta!ning byproduct material for amount of lodine 125, lodine 131, andcor atagent kits for the preparation and use certain medical tues. Iron 59 in escens of 200 microcurten. of radiopharmaceutleals contefntng by. (1) Americium 241 as a sealed source . . . . . product matertal for certain dfagnostic in a device for bone mineral analysis; fd) The general lleensee shall not re. uses (2) Cesfum 137 encased in needles and celve, acquire, ponares, or use byproduct ., all Stol> bdenum 99/technettum 9g app!!cator cells for topital. Interstitfal, material pursennt to guaragraph tal of ginerators for the elution of technetium and intracavitary therapy of cancer; thin section t
- 92m as pertechnetata for; (3) Cobalt 60 encased in needles and its gre.pt as prepackaged units til Drain imaging; appI1cator ce!!s for topleaf, interstitial. a blch are labeled in accordanne wtth the till Thyroid imagtng; and tntracavitary therapy of cancer: provlsions of a specific License luued s till Sattvary gland imssing; (4) Oold 108 as seeds for interstitfal under the provisions of $ 3211 of this tiv) Ulood pool imagtng other than therapy of cancer g, g, pitcenta localtration; (St fodine 12S as a sealed source in a g t v t Pitcenta locallration: devfee for bone mineral analysts: visions of a specific license laaued by an (vil Use with reagent kits for prepara. f oi fridtum 192 as seeds encased in Agreement filate, which authortaes man.
tion and use of rarttopharmaceuticals nylon rtbbon for interstlttal therapy of ufacture and distribution of lodine.125, containing technettum 99m as provide in canem iodine.131, carbon.14,' hydrogen.3 (trit. scragraphs (c) #28 and 138 (7) fittentfum 90 scaled in an appil. s2n Itrasent hits for preparauon of calor for therapy of superficial eye 'fke Wtko of Rule Masing. 38 rn 34llo, techneuum 99 a labeled: conditions. t)nemter it, t e73, rfotsat 90015798, VOL. 3e, NO ta-MONoaf, JaNUsef 38, lors T. .'s N * *" g + +N pys y m. ,e % 9m em +sein emm gy m. gw., , .,%% g , ,_w. , g_ , ,,pg, ,, ,,
a - . . ~. . - . . . . . ... _ -.-. . _ . . ._ .b 7;ts PROPOSED RULES . N
$ lum), or iron 59 for distribution to per. handling and storage of the radiophar- of 10 Cl"R Part 35 or under equivalent aons generally licensed by the Agree. maceuticals by group !!censees: and licenses of Agreement States.
ment State. (d)i1) The label ammed to each pack- The labels, leafleta or brochures re-
, , . . . age of the radtopharmaceutical contains quired by this paragraph are in addition information on the radionuchde, quan. to the labeling required by FDA and thev
- 4. Section 32.71 of 10 CFR Part 32 la tity, and date of assay and the label may be separate from or, with the up-umended by adding new paragrapha (b) afl1xed to each package, or the leaflet or proval of FDA. may be combined with tot and (Si and by amending paragraph brochure which me ompanies each pack- the labeling required by FDA.
Ic h a ll to read as follows: age, contains a statement that the radio" Non 1 Although the commiraion doce not t 32.71 Manufarture and li tribution of pharmaceuticai la licensed by the U.b. retruimte the manuf acture and diatributton bi produrt materiale for certain in Atomic Enerry Commission for distribu- or reagent sita which do not contain byprras-s it ro clinical or laboretury trating tion to persons licensed pursuant to uct material it doen regulate the une or auch un.lcr ernrral lii enae. I 35.14 and i 35.100 Oroup I. Group U. or reagent kita for the preparation or radio-Group IV of 10 CFR Part 35, as appro, pharmaceutica 1a containing byproduct mate-An application for a specific license to priate, or under equivalent licenses of rtal as part or its licanains ard regulation manufacture or distrtDute byproduct Agreement 8tates'- f the users f the byproduct matertal A r. y matermt for u er
- cerue of I 3 . g p (2) The labels. leafleta or brochurea eE."['#*" e7 [gm"'a" tert do [est e[N appruved if: required by this paragraph are in addi- have ble reserent tits approved by the ccm-tion to the labeling required by the Food minaton for une by persone ucensed pursu.
* + * *
- and Drug Administration (FDA) and ant to e 35 et and Group 111 of schedule A.
(b) We byproduct material la to be they may be separate from or, with the i 35 too or this chapter may submit the ger-prepared for distr.1 ution in prepacks.ged approval of IT.)A. may be combined with unent intonnauon speem in this i n 73 units of: the labeling required by FDA. 7. A new I 32.74 is added to 10 CFR
. . . . . 6. A new I 32.73 is added to 10 CFR Part 32 to read:
44 > Ilydrogen 3 itritium) in units not Part 32 to read:
$ 32.7i Manufarture and distrit tion of eseceding 50 microcurles each: 8 32.73 Manufacture and di.tribullan of source. or de, ice. con tainins by.
(5) Iron 59 in t.ntta not czeeeding 20 generatura or ressent hits for prep- product material for medical nae. Ni a h p ue na 5. An applicati n f r a specific heerde to manufacture and distribute sources and (c) Each prepackaged unit bears a An application for a specific license dettees containing byproduct matettal to durabic, clearly visible label: to manuf acture and distribute generators persons lleensed pursuant to 135.14 of i1) Identifying the radioactive con. or reagent kits containing byproduct ma* this chapter for the uaca listed in Group tenta as to chemical form and radio, terial for preparation of radiopharma- V of Schedule A. I 35.100 of this chapter nuclide, and indicating that the amount ceuticals by persons licensed pursuant mill be approved if: of radioactivity does not exceed 10 to 0 35.14 of thb chapter for the uses tal The applicant anthfles the gen. microcurtes of todme 131 lodine 125. or lhtalin Group UI of Schedule A.13 5.100 eral requirementa in 130.33 of this chap. carbon 14;' $0.microcuries of hydrogen of this chapter will be approved if; (Bee ter; 3 (tritiumil or 20 microcurtes of iron 591 Note 1) (b) ne applicant submits sufficient and ta) We applicant satisfles the general informauon regarding each type of
, , , , , requirements spectfled in i 30.33 of this source or device pertinent to an evalua.
chapter: Mon of Ita radiation safety, including: 5, A new 132.72 is added to 10 CFR (b) We applicant submita evidence (1) ne byproduct material contained. Part 32 to read: that the generator or reagent kit is to its chemical and physical form, and 3 32.72 Manufacture and distribution of be manufactured, labeled and packaged amount; radiopharmercuticale containing by. In accordance wllh (2) Details of design and constructlon produce snaterial for usedical mae i!I An effecttve New Dnis Application of the source or device; under group lirenses, (NDA) or a Illoloste Product License c3, Procedures for, and resulta of, pro. An applicauon for a specific license to frcm the Food and Drug Administrauon totype testa to assure that the nource or manuf acture and distrttute radio > hat. (FDA ). or device will maintain its integrity under maceuticals containing byproduct mate. (2) A " Notice of Claimed Investign* streamca Itkely to be encountered in nor= rtal for use by perso
- licensed pursuant tional Exemption for a New Drus mal use and accidenta; to 135.14 of this chapter for the uses (INDl" that has been accepted by the (4) For devices containing byproduct listed in Group I Oruup II, or Group IV I'UA; rnaterial, the radlauon profile of a pro-of Ekhedule A, i35100 of this chapter te) The applicant submita informauon gotyp, device; wW be approved If. on the radionueltde, chemical and phyal* t5) Detalla of quahty control pro.
tat he applicant sausfies the general cal form, packaging including maalmum cedures to assure that production sources requurmenta specified in 4 30 33 of this a.:tivity per package, and shleiding pro
- and devices meet the standards of the vided by the packaging of the byproduct destan and prototype tests; chapter tbl ' he [. applicant submits evidence material contained in the generator or 16 Procedures and standards for call.
that the radiopharmaceutical contalnins rengtnt kit; braung sourcca and devices; (di The label afazed to the generator gg, g, send and methods for labeling byproduct mat 4 Flat a til be rr anuf actured, or reagent kit contains Informauon on sources and devices na to their radioac. labeled, and packed in accordance with the radlonuellde, quantity, and date of tive content; 411 An effective new drug application assay; and 18) Instructions for handling and stor. INDAl or a Bioloste Product IJeerue tel ne label afnxed to the generator ing the source or device from the radta. from the Food and Drug Adminbtrauon or reagent kit, or the leaflet or brochm uon safety standpoint; these instructions (FDAl1 or which accompantea the generator or are to be included on a durable latsel at. (2) A *Nouce of Claimed Invest!sa* reagent kit, contains: tarhed to the source or device or attached tional Exemption for a New Drug (IND) (1) Adequate informauon, from a to a permanent storage container for the that has been accepted by the FDA: radiation safety standpoint, on the pro
- source or detice: Prodded. That instrue.
sc) We appitcant submita information cedures to be follomed and the equipment tionA a h!ch are too lengthy for such label 6 on the radionuchde, chemical and physt* and ahleiding to be used in eluting the may be summarised on the label and cal f orm, packastng including maximum generator or processing radioactive mm. printed in detall on a brochure stuch actluty per packhae, and shieldmg pro
- Lettal with the ressent kit, and la referenced on the label; vided by the packeging of the byproduct (2) A statement that this generator maternal shich is appropriate for safe or reagent kit tea appropriate) La sp.
,c, ne label afExed to the usurce or des tee, or to the permanent storage con.
proved for use by persons licensed by the i N or Rule Waalag 30 rn 84110, to 1 ergy O mm sa n purs W th
" ptofsat etellrts, VOt 39 NO Is.-#0N0a?. J ANUss? ll,1974 d
. PROPOSED RULES 2 t.V e tity, and date of assay, and a statement For the Atomic Energy Commission.
that the (name of source or devicep la ll* Oonoon M. ORANT, cerned by the U.S. Atomic Energy Com- Acting Secretart of the Commbston. mluton for distribution to persons 11-censed pursuant 16 Il 35.14 and 35.100 lrn ooe.76-1878 mied -as-74.8:4s aml g Oruup V of 10 CFR Part 35 er under equivalent licenses of Agreement States: Prortdcd,'Itat such labelins for sources which do not require tons term storage se g. sold 198 seedst may be on a leaflet or brochure which acccmpanies the sources. t Bec St. 181,182,183. Pub.1 83 703,68 Stat. 833. 948. 863. I s4. as amended (43 US.C. 3111. 3201,2232.2233)) Dated at Germantown, Md. this 15th day of January 1974. l 9 ft0tsAt 99411198, YOt. 39, NO.1440NOAY, JANUA8f 31,1974 l
r 'll t
s -
' *- 3333 Aged M Ot&ATIO906 ' 261C l
o o Ylee 10 La CHAMER M70MIC ENE24V COMMIMicH Group useneing fee Cartsen Reedesal Usee
%e AAosn!c Ebergy Qornmtulon pub.
!!ahad las the NL Rectstaa on Janu.
any 11,1M4 (33 FE 2380 proposer!
=Ph leIta resplatJons in 10 CPR Parts 3L TL and @ lo add carta'n materkla and tones to Groupe I and !! of medical taes of b7 product matettal, to edabush severmi new groups of medical uses, to apedts 11ceruing requirementa for the distributaan of byproduct matertal te group licensees, and to add new by.
prodnet snatarial to the saneral license for certain ha sure clinical and laamrn. toryteaMus. Inessested pm coas unse levnad to sub mu weltaan semansmas or ausecoueme for censideretten la conneeuna eleh the prepened aw=*eas nuhin et dass after geth af the noure of pro. pened rule mahang an uns Fastaas has.
. serum, 4
7W88A4 Dmitt4 V04. M, h0. I3bWEDN00haV, MS9 17, t974 y.__.- _ . . . . .
- . ._ _ m _
2M ll RULES AND RE^ULATIONS Af ter conalderation of the comm;nts fr:m cuch !! censed manufacturers, and i 25.14(b) have been renumbered ace:rd-received end other factors inTolved, the to ensure the Ovalhb111ty of licensed ingly. Confirming changes h v2 tan Commission has adopted the proposed products for group licensees, 88 32.72, made in $ 35.100 to delete references to amendments to 10 CFR Parts 31,32, and 32.73, and 32.74 will become effective 135.14 (b) (4) concrrning such registra-
- 35. sith certain modifleations. 150 days before the amendments to tion.
Some modifications in the regulations, il 35.14 and 35100 become effectJve. In (36 Paragraph 35.14(b) (71 which twed on discussions with the Fmd and the meantime.11 censes that authorize the would have required hospitalir.ation of Drue Administration (FDA), have been present uroups I and II and licenses that patients containing more than 8 milli. made in order to provide an orderly authortie specined materials and unes curies of lodine 131 for the treatment of transition of. the regulation of pharma. will remain in effect. Further, il 32.72, thyroid carcinorr.a or more than 23 m1111-crutical safety and effectiveness of radio. 32.73, and 32.74 have been changed from curies of gold 198. has been deleted pharmaceuticals from the Commission to the proposed rule to provide that any These values are the most conservative the FDA. and to prevent any disruption manuf acturer who makes application ones recommended by the National in the existing supply and distribution of within 60 days of the effective date of Council on Radiation Protectlan and these drugs. ll 32.72. 32.73, and 32.14 to distribute to Measurements in NCRP Repcrt No. 37 Licenses issued by the Commission that group licensees a product that was dis- and were not intended for use in all are in effect on the effective date of these tributed commercially to licensees of the situations. amendments and that specifically au. Commission on or before the effective Require nenta for hospitalization of thorize investigational use of byproduct date of ll 32.72. 32.73 and 32.74 may such patients will continue in accord-material will continue in effect accord- continue distribution of such product to ance with current licensing practices, ing to their terms and until their expira, group Itcensees until the Commission 1s- pending considers Jon of modifications tJon dates. Specific licenses of broad sues the license pursuant to 132.72, to such require.he its in future rule scope that are in effect on the enective 32.73 or 32.74 or notifies the applicant changes. (48 Section !J 14(b)(8)(1), renum-date of these amendments and that au- manufacturer otherwise. Sections 32.72 and 32.73 have been bered i 35.14(b)(5# (1), has been changed thorize the use of byproduct material for inedical research. diagnonts. and therapy changed to provide that a manufacturer to provide that required leak tests on without listing specific materials or uses who appIles for a license to distribute sources and devices may be permitted at will continue in effect according to their radiopharmaceuticals, or generators and intervals longer than six months, as is terms and until thefr expiration dates. reagent kits for the pteparation of radio- now provided for certain industrial
'Ihe authority granted in these Itcenses pharmaceuticals sha:1 submit evidence sources. when sufficient information is by the AEC does not, however, exempt that such product will be manufactured, furnished by the manufacturer to dem-the licensee from any FDA regulations. labeled and packaged in accordance with onstrate that such longer interval is After the effective date of the amend. the Federal Food. D ug. and Cosmetic justified by performance characteristics ments, the Commission mill continue to Act or the Public IIerdth Service Act or of the source or device and by design issue speelfic licenses for materlah and that the manufactur? and distribution features that have a signincant bearing uses which are not included in the group of such product are not subject to those on the probability or consequences of heenses pursuant to il 35.14 and 35.100. Acts. This will provide more flexibility in leakage of radioactive material from the Home well estab11Ahed diagnostic and how compliance with appropriate Food source or device. Provisions for approval ana Drug Administrttion requirements of leak test intervals longer than six therapeutte uses are omitted from the can be established as a requirercent for months have been added to i 32.14.
groups because they involve radiation inuance by the Commtaslon of a license (5) Bection 35.14(d) has been changed protection procedures which are not similar to those required for the use, t distribute radiophtrmaceutical prod- to provide additional flexibility in the llated in the groups, Some other omitted ucts to group licenseer. use of byproduct material for calibra. The present title cf 10 CFR Part 32 Lion and reference standards by provid. tuen. auch as metabolic tracer studies' is "Spwinc 1.tcenses to Manufacture, ing larger sources of certain star $dards are not now regulated by FDA as diag-nostic or therapeutic radiopharmaceu. Distribute, or Impor t Exempted and which are needed and used in nuclear llcal tues but FDA has informed the AEC &nMaHy Ucensed ,, Items Containing medicine and by establishing more spe-Ilyproduct Material . 81nce the new cific manuf acturing and use standards that it intends to promulgate regulations Il 32 72, 32.73 and 32 74 apply to licens- for such larger sources. regarding these uses in the near future. ing the manufacturer of radiophar- 161 Xenon 133 has been deleted from Authorisation to use new investigational maceuticals, sources and devices cor* 1 35100 tal Group I and Ib> Oroup II radlopharmaceuticals which are not in talning byproduc t riaterials for dis
- becauw the use and disposal of zenon the group lleenses will be granted upon tributton to group agreine licensees, the 133 requtres specia!! zed ec,utprient and nottf! cation from FDA that it has ac. titJe of 10 CPTL Part 32 is changed to procedures for occupational and puhhe repted a "Nottee of Claimed Investira- "8pecific Ucenses to Manufacture, Dis
- health and safety that are not required tional Esemption for a New Drus" (INDI in accordance with previously established tribute tatning or Imp Hypr ductrtMaterial Certain ,, Items Con
- for other byproduct materials tn these administrative procedures until such groups This radioisotope will continue time as PDA terminates its existing ex.
The following charges in the effective to be specifically licensed for blood flow, emption to 21 CFR 312.1 (formerly 21 rule from the proposed rule are based pulmonary function and heart and lung CFR 130 3 p for radiopharmaceuticals primarily on the public comments imaala r atudies. (7) Iodine 131 as II!8A for cisternog. and brings the control of safety and received. efficacy of these drugs fully under ita fin Beetion 3514f alf 3) has been modi. raphy has been deleted frcm I 35100ibe regulation, fied to delete the enumerauon of spectne Group II because this product un h.sh When the amendments to 10 CPTt Part classes of persona Other than phyalciana, specific activity form suitable for Cis. 35 become effective, byproduct material aho participate in the une of radloacute ternographe has not been made com. for tue under group brenses rmat have materials, since classes of persons in ad. mercially available or licerned by FDA been manufactured, labeled, packaged. ditkm to those enumerated can be in. for this purpme.1-131 em low specine and distributed in accordance alth a volved in the human use of radioactive activity DIBA which is liceed by FDA specifle licerve lasued by the Commis. materials. and distributed for other uses. is not Mon pursuant to i 32 72, 32.73, or 32 74 (2) Bection 3614abi its and ISi, appropriate for use in cisternography or in accordance with a specific license which would have required persons usine because the use of low specific aruut> laaued to the manufacturer by an Astee. Investigational radiopharmaceuticats to IlfHA for cisternography can catue ad-ment State pursuant to equivalent titate regnater alth the Commianlon have been verse reactions in patientt %)s use sill regulations In order to allow manuf ac. deleted because such registratkm would be reconsidered when a saltable product turers of such products to be licensed be an unneccuary duplkation of regula. la commercially available, prior to the efecure date of require
- tory effort by the Commlaslon and the (81 ne una of gold 198 and phos.
rnents for licensees to obtain matartale FDA. %e subsequent paragraphA of phorus 32 colloids for interattual use MDf eat Stollfle, YOL $9, Pe0.136--WIDNf 60af, mf i t,1974 J 3 3
RULIS'A85 REGULATIONS 26115
* - heae been deleted from I 35.I'0 @ l 35.100, the C:mmMon etll conskkr regulations on or before October 15.1974 t,)roup IV beccme the training, espert- amendment of tha heenne for all the for a teense to manuf acture and das-crue and procedures requirements for groups of unes in 5 35.190 which inchade tribute a radioph rmaceutical that the three seiden used procedures are d1Re- the uses peeviously Dcesued. appikant distributed commercially on ent frosa such requiremments far other Puesmant to the Atomic Energy Act of or before August 16. 1974 on which ap-materials and uses in the group. neae 1954, as amended, and sectums 553 and plication the Commk.slon or Agreement radnopharmaceuticals will tumt'nue to be 553 of titje 5 of the United 8tates Code, 8 tate has not acted.
spectfhcally licensed foe intersuttal une following amendments to 10 CFit (21 Wr Group III, no licensee shall therapy. Parts 31,32, and 35 aLre pubitshed as a (9) Technetium 99m as pertechnetaic document subject to codiacation. treelve possem, or tee generators or re. for blood flow studies and mercury 197 agent kits containing byproduct material as etoormerodrin for kndney funcuern PAM ttUMAN U5ES OF BYPRODUCT or shall use reagent kits that do not con-studies have been added to I 35.100(a8 MATERIAL tain byproduct material to prepare radio-Group I, lodine 125 as sodlum lodide for 1, Section 35.14 of 10 CFit Part 351s pharmamuticals contatoms byproduct thyroid traagtng has been added to ansended to read as follows: material, except; ein Itengent kits not containing by. 135100(b) 99m Oroup II, for as pertechnetate andusetechnetkmn with re- $ 35.51 SperiAc hermes fric certain product rnaterial that are approved by asent kits for preparation of radio- svuer of swdwal use, of b=prodset the Commission or an Agreement Stata material. pharslaceuticals containing techt etimn for use by persons licensed pursuant to 99m has been added to i 35.100(c) Oroem fa) Subject to the provistons of para. this 135.14 and Group III of Schedule III in order to be constatent with currert paphs (bl. fc) and ad) of tlus section A. I 35100 or equivalent Agreement State licensing practices for well statAtahrd an application for a specific license pur.' regulations; or proceduret Bubsequent Instings in suant to 13511. I 35.12 or i 3513 for nr.y (11 1 Generators or reagent kits con-these groups have been renumbe td rnedical use or uses of byproduct mate- taining byproduct material that are accordingly. rial speelfled in one or more of Groups I manufactured, labeled packaged, and (10) Bection 35.100(di Oroup IV has to VI. Inclustve. of f 35100 will be ap- dbtributed in accordance with a speethe promt for all of the uses within the license isstred by the Commission pur-f ther peutic u a ntw group or groum shich include the use susnt to i 3173 of this chapter ur by an require fact!!tles and precedure. for r uses specihed in the application if: Agreement State pursuant to equivalent hospitallsation of pntlente for pu vones ili De appliesnt satistles the re. State reculations; or of radlauon safety and i 35 n00tes quirements of I 3511, f 33.12. or i 3513; f flip Generators or rennent kits that Oruup V for therapeuuc uvs 11at re. 126 The appliennt, or the physician the manufacturer distributed on or be-quire facilitics and procedurts for hon. deswitated in tha application as the in. fore Auguet 16.1974 for wb!ch an appli. pitalization of patienta for radiation d!rldual treer, ha* adequate clinical ex. cntion for license or approval was filed safety. Proposed I 35.100(en Ort up V for perience in the types of uses included in with the Commission pursuant to i 32.73 sources and devices has been renum, the group or groups; of this chapter or with an Agreement bered i 35.100(f) Group VI. Conforming (3) The applicant or the phyalcians State pursuant to equivalent regulations paragraph number changes have been and all other penonnel who will be in- on or before October 15, 1974 on which made in the cross references in 5 35.14 volved in the preparation and use of the application the Commission or Agree. tb>. byproduct material have adeq' rate men t State has not acted. til) Editorial and clattfj tcg changea training and expertence in the handling hase been made, (31 For Group VI no licensee shall of radmactive amaterial appropriate to receive, possess, or use byproduct ma. A number of commentators sugge'sted their part ripetion in the uses included terial except as contained in a source that cobalt 57 be added to 13514(d) as in the group or grouns; or denice that has tieen manufactured. cahbration and reference standards, to f t) The applicant's radiation detection labeled, packaged, and distributed tu
! 35100(at Group I as esanocobalamin, arid necesirring instrumentation is ade. accordance alth; and to 11 *,111 and 32 71 for in titro use. quate for conductJnr the procechtres in. Un A specific IJcense 1 saved liy the While cobalt 57 is a steely used isotope volved in thre uses included in the group Commisdon pursuar4 to i 32.14 of thu in nuclear medicine, it is not byproduct ofgroups; cle r; or runtertal as defined in tae Atomic I*nergy
- Act H e.. it is not pror'uced in a nuclear tSt De appliennt's radiation safety 'M A speelfic lleense issued to the reactor) and it is therefore rtot subject op, rating procedure
- are adequate for manuf acturn by an Agreement state to regulation by the Comm!'utost handling and disposal of the radionetive purvaant to equivalent State regulations:
Two comrnentatots surgerted that 1* matertal involved in the usas included or 125 as interstitial preds be added to in the group et groups; thH An appheation fLled with the 1 35 100tel Oroup V, now renuasbernt Ib) Any lleennee who is authortzed to Atomic Energy Commission pursuant to 8 35100f f Orvup VI. his Ismtece arwt ttse tryprtwiert material pursuant ta one f 32 74 of this chapter oc with an Agree. , trse is still undrfy ener clinical evoksation or more groups in II 3514<ai and 35100 ment 8 tate pursuant to cirulvalent state i la strhjeet to the follortng condttlons: regulations on or before October 15 l st bit.*he It it t!) Pbr dreups f. II. IV, and V no 1974 for a license to manufacture n [ Section 3 4 provid t at an 11 censer sha!! recche, possess, or use by. source or device that the applicant dia. plication foe a heenac for any use of t r. product material etrept as a radio. tributet! coramercially on or before Au. product material in one ef the groups pharrrusceutteal manufactured in the guet 16, line on which application the mill te approved for at: of the uses in form to be adminletered to the patient, Commbston or Agreement State has not that group tf the appifrant's expertenm. late ted, packared, and dfstributed in ac. acted. traintng, equitwnent and recredorest are edaMe th W Par Grwp E any Bunsre who adequate for all tmen in that group In (18 A specific licerue Lwed by the tres generntars or reagent kita sha!! some casm the aptiucant's quahncettness Cor:mLtdon pursuant to 132 73 of this clute the generator or process radio. may be approprtate foe certain speelhed chapter; or active matertal with the reagent Idt ht I materials and wes t;ut met for an of the Ott A spectne license tvued to the accordance with law.tru6tions which are uses in a gr6up, in whAch ese the manufacturcr by an Agreement State approved by the Atomic Energy Comnus. hernic may tic 19ued only for specified pursuant to equ!Yalcut Sta fe regulations; M or an Agreement Hble add are fM.
! I n o already hWda a dili An app!! cation Illt d with the "I N "" "#"*""
auccine license for spectned medical tase.s Atomie Fnergy Commtalon pursuant to attached to or in the leaflet or brochttre of bypruduct material applies for a 132?f2 of this chapter or with an Agree. that actempaftles the generator or re. heenw amendment to add nns use in rnent State pursuant to equhalent State agentkit, I reces At Hessite, vot 39, ho.134-wteNeuuf, Aar 17, Ier4 e e a:
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g , RULES' AND REGULATIONS 26116 . (cJ Any licensee who is licensed pur- leak tested within six months prior to 85: For Group VI any licensee who suant to paragraph (a ) of this section for the date of use ( smesses trid uses sources or devices con- one ar more of the medical use groups in (3) The leakorti+t transfer. shall be capabic of - tJin!n2 tnroduct matertal ahall; aIa Cruw each source or device con- 1 35.100 also is authortzed to use by- detecing the uttaenee id 0 005 imesvrmic tatning more than 100 microcurtescense of pmfuct in i 31.11material under of this chapter foethe the general ple. The test 11- of radioactive sample rnatertal ahm11 be innen f tvm on the teat sam-byproduct material with a half-life spedfled in vitro usa without fillas Form ' the sa dtd source or from the surfa e* of * ' arreter than thirty days, except tridtum AEC-483 as required by I 31.II(b); Pro- the aevice in which the scaled source L* k. L 192 necda encaned in nilon ribbon, to be tfded, 'Ihat the licensee is subject to the permanently mounted or stored on w hich - fI intnl for runtnmination and/or Icakage other provisions of f 31.11. contamination m!aht be expected to ac- - nt Intervnig not to execed afx months or cumulate. Records of leak test results nt such other Interints as are approved suant (d) Any licensee who to paragraph (a)isiflicensed pur- shall be kept in units of microcuries and this section h matntained for inspection by the Com- i? t y the Atomic Energy Commisstor. or an for one or more of the mkcal use groupe ! Agreement State and described by the in i 35.100 also is authorized, subject to mission. (3) If the leak test reveals the pres-m:nuf teturer on the label attached to the provisions of paragraphs (e) and (f) once of 0.005 microcurie or more of re-th? source, device or permanent con- of this section, to receive, possess, and 4 tiln;r th;reof, or in the leaflet or bro- use for calibration and reference stand- movable contamination, ahall immediately withdrawthe thelicensee sea!cd W chure t*hich accompanies the source or ards: device. Each source or device shall be so 81) Any byproduct material listed in source from use and shall cause it to be - te ted prior to its first use unless the Group I. Group II or Group IU of decontaminated and repaired or to be buppil r furnishes a certificate that the Schedule A. I 35.100, with a half-life not disposed of in accordance with Parts 20 and 30 of this chapter. A report shall be sourc2 als months or device prior tohas the been so tested within longer than 100 days. In amounts not to -nled within 5 days of the test with the transfer; exceed 15 m1111 curies total; (11) Assure that the test required by appropriate Atomje Energy Commission 3 (2) Any byproduct material listed in Regulatory Operations Regional Othce g; p:ragt ph (b)(5)(D of this section is 4 c pable of detecting the presence of Group I. Group II, or Group A, 8 35.100 III of listed in Appendix D of Part 20 of this with half-life O 005 microcurie of radioactive material Schedule chapter describing the equipment in- k greater than 100 days in amounts not to volved, the test results, and the corrw-on th2 test sample. The test sample shall cxceed 200 microcuries total; tive action taken; k be taken from the source or f rom the sur. (3) Technetium 99m in amounts nog fcces the device in which the source (f) Any. licensee aho possesses and k i is p;rmanently or semipermanently to exceed 30 millicuries; uses calibration and reference sources mounted or stored on which one might (4) Any byproduct material, in pursuant to paragraph (d)(4) of this expect contamination to accumulate. amounts not to exceed 3 millicurles per section shall: Records of Irak test results shall be kept source, contained in calibration or refer, (1) Follow the ridlation safety and in units of microcuries and maintained ence sources that have been manufac.handling instructions approved by the In f:r inspection by the Commission; tured, labeled, packaged, and dl.itribu. Atomic Energy Commission or an Agree-(till If the test required by paragraph ted in accordance with; . ment State and furtIthod by the manu- 6 (b)(5) a1) of this section reveals the pres. (i) A spect!1c license issued by the facturer on the label attached to the $ 4 rnc2 of 0.005 microcurie or more of te- Commission pursuant to i 32.74 of this source, or permanent container thereof, movabl2 contamination, immediately chapter; or or in the leaflet or brochure that ac- $ rithdra 'he source from use and cause (11) A specific Itcense tsaued to the companies the source, and maintain such {s it to be decontaminated and repatred or manufacturer by an Agreement State instruction in a legible and conveniently
- to be disposed of in accordance with pursuant to equivahnt State regula. available form; ~
Commission regulations. A report shall IIO"8; Of PDNMap% MWW h be n!ed within 6 days of the test with the ( 111 ) An application filed with the ventory to account for all sources re-cppropriate Atomic Energy Commission Atomic Energy Commission pursuant to celved M pm% he of tM llegul: tory Operations Regional Offlee i 32.74 of this chapter or with an Agree- inventories shall be maintained for I listed in Appendix D of Part 20 of this ment State pursuant to equivalent State inspection by the Commission and shall chipter, describing the equfpment in. regulations on or before October 15,1974 include the quantitles and kinds of by- f e volved, the test results, and the correc. for a license to manufacture a source product material location of sources. I Lava nction taken; that the applicant distributed commer. and the dnte of the lnventory' 1 (lv t Follovv the radlauon safety and chily on or before August 16,1974, on
- 2. SectNn 35100 of 10 CFR Part 35 is )8 handling instnictions approved by the which application the Commission or amended by changing the title and sub-Atomic Energy Commluton or an Agree. Agreement State has not acted. titles. by ndding certain new uses to the j ment State nnd furnished by the manu.
ie'ti)(1) Any licensee who popesses present parsgrapha (al Orcup I and (br , f acturer on the label attached to the sealed sources as calibration or refer. Oroup II, and by adding new parngrsphs ;
#60urc7, device or permanent container ence sources pursuant to paragraph (d) (c) Oroup III, (d) Group IV, de) Oroup ,
th;reof, or in the leaflet or brochure that of this section shall cause each sealed V, and (f) Group VI. The section as ! accompanies the source or device, and source containing byproduct material, amended, will read as follows: ! initntain such instruction in.a legible other than hydrogen 3. with a half-life ! and conveniently available form; greater than thirty daya in any form $ W uk mups of mcde. tv) Conduct a quarterly physical in. other than gas to be tested for-leakage cal unce of bypemlurt material. < vintory to secount for ali sourcea and de- and/or contamination at intervals not fa) Croup 1. Use of prepared radio- , vices received and posananed. Recon!s of to exceed six months. In the absena of pharmaceuticals for certsin diagnostic th) innntories shall be gnalntained for a certificate from a transferor indicating studles involving measurements of tT-inspection by the Comm!ssion Inclial] the quantitics and kinds ofand by-shall that a test has been made within six take, dilution and excretion. This group months prior to the transfer, the scaled does not include uns involving imadng product material,lormtlen of sources and source shall not be used until tested, and tumor localtrations, devices, and the date of the inventory; Protidt f, hoteerer, That no led tests (vi) Assure that needfee or standard ate required when: (1) Iodine 131 as sodium luhde medic t applicator cella containing co. (NaI*) for measurement of thyroid up. (a) The source contahu 100 micro. take; tnit 60 as wtre are not opened while in curies or less of beta and/or gamma th) lic nsee's possenston unless sperib emitting material or 10 microcurica 82 orIodine (NAI") 125foras sodlum lodideon thyroid up-measurement cally cuthortred by a lleenne lasued to less of n!pha emitting material, or him by the Atomic Energy Commtufon; (D) The ersled source is storad and is take; ( vti) Assure that patiente containing (3) Iodine 131 as lodinated human cobalt 60, ceslum 137 and/or tridlurn 192 not being usal; such sources shall, how. implants shall remain hospitalised useunt!! ever,unless or transfer be tested they have for been leakage tion ofprior blomt to andanybloodserum plasmaalbum!n volume; (llISA) for deter the implants are removed-MDltAL Rtollitt, VOL. 39, NO,130--WIDNt10aY, JULY 17,1974 L. . .
.w nw n_ . . ~ . __. - _ m _ _ _.._._. _ _ .
, RULES AND REGULATIONS 2G147 s4) Iodin 2 12S as lodinated human (9) Iodine 131 as lodinated human (vD Polypherphites for bonr imaging;
$ serum altrumin (DISA) for determina- serum albumin (DISA) for placenta lo. (vil) Macroaggregated human scrum tions of blood and blood plasma volume; calization; albumin for lung imaging;
#57 Iodine 131 as labeled rose bengal (10) Chromium 51 as sodium chro- (villa Disodium etidronate for bone for liver function studies; mate for spleen imaging; imaging; (6) Iodine 125 as labeled rose bengal (11' Chromium 51 as labeled human (4) Any generator or reagent kit for m' for liver function studies; serum albumin for placenta localization; preparauon and diagnosuc use of .
) (7) Iod!ne 131 as labeled fats or fatty (12) Gold 198 in colloidal form for radiopharmaceutical containing by.
-- acids for fat absorption studies; liver imaging; product material for which generator or I (8) Iodine 125 as labeled fata or fatty (13) Mercury 197 as labeled chlor- reagent kit a " Notice of Claimed In-acida for fat absorption studies; merodrin for kidney and brain imagmg; vestigational Exemption for a New Drug" (9) Iodine 131 as labeled todopyracet, (14) Mercury 203 as labeled chlor- (IND6 has been accepted by the Pood sodium todohippurate, sodlum distri- merodin for brain imaging; and Drug Administration (FDA). zoate, distrizoate methylgluemmine, so. (15) Selenium 75 as labeled seleno- Ed) Group fF. Use of prepared radio-dium diprotrizonte, sodium acetrizoate, methionine for pancreas imaging; pharmaceutimla for certain therapeutic or sodlum iothalamate for kidney func. (16) Strontium 85 as nitrate or chlo- uses that do not normally require hos-tion studies; ride fcr bone imaging 11. patients with pitalization for purposes of radiation (10) Iodine 125 as labeled todopyracet, suspected or diagnosed cancer; safety: sodium todohlppurate, sodlum distri. (17) Technetium 99m as pertechnetate (1) Iodine 131 na lodide for treatment zoate, distrizonte methyglucamine, so. for brain imaging; of hyperthyrtodism and cardiac dium diprotrizoate, sodium acetrizonte, (18) Technetium 99m as pertechnetate dysfunction; or sodium lothalamate for kidney func. for thyroid imaging; (2) Phosphorus 32 as soluble phos-tion studies; (19) Technetium 99m as pertechnetate phate for treatment of polycythemia (11) Cobalt 58 as labeled cyanocobal- for salivary gland imaging; vera, leukemia and bone metastases: amin for intestinal absorption studies; (20: Technetium 99m as pertechnetate (3) Phosphorus 32 as colloidal chromic (12) Cobalt 60 as labeled cyanocobal. for blood pool imaging including pla- phosphate for intracavitary treatment amin for intestinal absorption studies; centa localization; of malignant effusions; (13) Chromium 51 as sodium chro- (21) Technetium 09m as lat'eled sulfur (4) Any byproduct material in a mate for determination of red blood cell colloid for liver and spleen imaging; radiopharmaceutical and for a thera-volume and studies of red blood cell (22) Technet!um 99m as labeled mac- peutic tre not normally requiring hos-survival time; roaggregated human serum albumin for pitalization for I;urposes of radiation (14) Chromium 51 as labeled human lung imaging; safety for which a " Notice of Claimed scrum albumin for gastrointestinal pro. (23) Any byproduct material in a Investigational Exemption for a New tein loss studies; radiopharmaceutical and for a diagnostic Drug" (IND) has been accepted by the (15) Iron 59 as chloride, citrate, or use involving imaging for which a Food and Drug Administration (FDA*. sulfate for iron turnover studies: " Notice of Claimed Investigational Ex. (e) Group V. Use of prepared radio. (16) Potasslum 42 as chloride for po- empuon for a New Drug" (IND) has pharmaceuticals for certain therapeu. taasium space determinattens; been accepted by the Food and Drug tic uses that normally require bompital-(17) Bodium 24 as chloride for sodium Administration iFDA). ization for purposes of radiation safety: space determinations; (c) Group lif. Use of generators and (1) Oold 198 as colloid for intracar. (18) Technettum 99m as pertechne- reagent kits for the preparation and use itary treatment of malignant effusion ; tate for blood flow studies; of radlopharmaceuticals containing by- (2) Iodine 131 as lodide for treatment (193 Mercury as chlormerodrin for product material for certain diagnostic of thyroid carcinoma: kidney function studies; uses. . (3) Any byproduct material in a ra-(20) Any byproduct material in a (1) Molybdenum 99/tec21netium 99m diopharmaceutical and for a therapeu. radiopharmaceutical and for a diagnostic generators for the elution of technetium tie use normally requiring hospitaliza. use involving measurements of uptake, 99m as pertechnetate for: tion for radiation safety reasons for dilution, or excretaon for which a "Nottee (D Brainimaging; which a " Notice of Claimed Investiga-of Claimed Investigational Exemption (lie Thyroid imaging; tional Exemption for a New Drug" (INDl for a New Drug" (IND) has been ac- (111) Sallvary gland imaging; . has been accepted by the Food and cepted by the Food and Drug Adminis. (iv) Blood pool imaging including Drug Administration (FDA). tration (FDAL placenta localization; (f) Group Ff. Use of sources and de. th) Group ff. Use of prepared radio. (v) Blood flow studies; vices containing byproduct material for pharmaceuticals for diagnostic studies (vD Use with reagent kits for prepara. certain medical'uses: involving imaging and tumor localiza- tion and use of radiopharmaceuticals (1) Americian 241 as a sealed source tions. containing technettum 99m as provided in a device for bone mineral analysis: (1) Iodine 131 as sodlum todide for in paragraphs (c) (3) and (4) of this (2) Cealum 137 encased in needles thyroid imaging: section; and app!!cator cells for topical, inter-(2) Iodine 125 as sodium todide for (2) Technetium 99m as pertechnetate stltial, and intracavitary treatment of thyroid imaging: for use with reagent kits for preparation cancer; 4 (3) Iodine 131 as lodinated human and use of radlopharmaceuticals con- 13) Cobalt 60 encased in needles and I serum albumin (IHSA) for brain tumor talning technetium 99m as provided in apphcator cells for topleal. Interstitial. ' localizations and cardlac imaging: paragraphs (c) (3) and (4) of this and intracay1Lary treatment of cancer; [ (4) Iodine 131 as ma:roaggregated section: (4) Gold 198 as seeds for interstitial lodinated human serum albumin for lung (3) Reagent kits for preparation of treatment of cancer; , imaging; technettum 99m labeled: (5) Iodine 125 as a sealed source in (8) Iodine 131 sa colloidal (micro. (D Bulfur colloid for liver and spleen a device for bone mineral analysis; f' aggregated) todinated human serum imaging; (6) Irtdlum '192 as seeds encased in albumin forliver imaging: (ID Iron aacorbate diethylenetriamine nylan ribbon for interstitial treatment I (6) Iodine 131 as labeled rose bengal pentancette acid complex for kidney of cancer; > for ilver imaging; imaging: (7) Strontium 90 scaled in an ap. (7) Iodine 131 as todopyracet, sodium (11D Diethylenetriamine pentancetic plicator for treatment .of superficial i todohlppurate, sodium diattir.oate, dia. acid (Sn) for kidney imaging and kidney eye conditions. ! trisonte methylglucamine, sodlum d! Pro- function studies; trizoate, or sodlum acetrisonte for kid. (iv) Diethylenetriamine pentaneetic PART 31--4ENERAL LICENSES FOR I ney imaging; acid (8n )for brain imaging; BYPRODUCT MATERIAL (0) Iodine 131 as sodium ItmMe for (v) Ifuman serum albumin micro- 3. Section 31.11 of 10 CFR Part 31 la can11ac imagingl spheres for lung imaging; amended by adding new paragraphs (a) [ t g . g ,m .. m ... . l . - 10 ,,. 1,,. .
~
Mils RULES AND REGUfAT40NS aral (Se, by amending the first PART IFACT11RE, 32-SPEclHCDISTRIBUTT LICENSES TO (3) De app;acant submits haforma-4, sntenes of paragraph (b), and by ORMAN-IMPORT ten on the r:dianuclide, chemical and CDrTATM fTEMS CONTAfMfMG STPROD- physical form. I ackaging including max-ur.cnding paragraphs (c)(1) and (d) 1ruum acuvity per packmae, and ahleld-UCT MATERIAL Is to r"ad as fo!!ows: 4. The title of 19 CFR Past 32 to ing provided by the packaging of the by-l 31.11 f orneral flernee for une of try, armended to nad as set 8erth absee. pmduct material tMt is appmpriate for peuJoca material for certaba to 34tro 6. Sestaat: 32.72 of 10 CFR Part 32 le safe handling a-d storage of radlo-elin cul or laboratory seating. ,' amended by adding new fl 32.7tth) (4I pharinaceuticalt by group licensees; and f) A general liceme is hereby issued and (5) and by amending i 32.71tcHI) (4)(1) Da label ammed to each pack-e any phystetsn. ci!nical laboratory or to reed as follows: age of t.he radhrharmsceutic'I cantaAns towpit:1 to steche, acquire, ponne% information on the radionuclide quan- .ransfer. or use, for any of the following 8 32.71 Mannfecture ami distrilmeiren of tity, and dat? of away, and the label af-tted tests,in accordance with the pro- pmaneg material for revtann in fists! to cuch I ackage, or the leadet or dalons of paragraphs (bt, f el, (d), (e), = ro clwucel ne lehersenry testing brochum which secompsnica cacli pack-tnd if) of this section, the following by. aandees m wellu m e. a e, contains a slatement that the radio- )roduct m.terials in prepackaged unita: An application for a specific license to pharmaceutical is licensed by the UB.
. . . e manuf acture or dhtribute byproduct ma- Atomic Energy Commissicn for distribu.
tion to perwtt licenaed rursusnt to (4) flydrogen 3 (tritium),in unita q terial of j for 31.11useofimder the general this chapter a til belicense approred I 35.14 and i 31100 Group I. Group II, xceedlag 50 microceries each for use in Group IV, or Group V of 10 CFR Part 35. n vitro clinical or laboratory taste not II: * * * *
- as approorlate, or urWr equivalent 11 nvolving internal or externaJ pamfalz- (b) The byproduct matertsJ is to be censes of Agreement States or that an mtion of byproduct material, or the pnapand for didr umas tan tu prepackaged arplication for such Ilcense has been adtition therefrom, to humaan beines or filed wl:A the Commi zim on or before intmals. units of: October 15,1974 ar'd in still pendirut.
- 45) fron 59,in unita not exeeding 20 . . . . .
(11) he labels. las!! cts or brochurcs nicrocurus each for use in in vitro clin!- (4) Ifydrogen 3 (trittum) in un!ts not required by that paragraoh are in addf-
- al or laboratory tcMa not involving in- exceedios 50 microcuries each; tion to the labeling required by the Food [
- ernal or external administration of by, (5) Iron 59 in units not exceeding 20 and Drug Ad'nin]*tration (FDA) and a
.>roduct material, or the radiassan thero- micipenries cach. they may be ser'ar-te from or, with the from, to human beings, or menak (c) Each papackaged mit bears a approval of FDA. m1v be combined alth f' tbl No person shall recche, magmire, durable. clearly vis!ble tabel. the labeting required by FDA. j posscas. use, or transist byssedust mate. W Identifying the radioactive con- (b) If an sprilestion h filed pursuant rial pursuant to the general nnessee es. tents as to chemical form and radio
- to paragraph tal of this arction on or tatltshed by paragraph (a) of this soo- nuclide, and indicating that the amount before October 14,1974, for a license to a titen until he has flied fetin AEC-483, of radioactivity dm mt exceed 10 manufacture and distribute a red 60 I "Itegistration Certificate In WtTo Teet- miemunes of tod1m m, MM m, a pheutical that was .5stributed ing with Byproduct Material Under O.st- cahn 14150 rnlem:uries of hydrogen 3 commercially ort or before August 14.
arallAcense," with the Matertala Branch, (tritium) : or 20 microcuries of ima 59, 1974, the arn4 Leant may contanue the Directorate of Licensing, UE. AtomAc "Dd dhtributton of such redlorharmaceutical Energy Commission Washington. DC. * * * *
- to group licensees until the Commiedon 20545, and received from the Commission a validated copy of Fonu AEC-483 with 6. A new i 22.72 is maled to 18 CFIt issues the Itcense or notifies the appM-cant odieraise.
registration number assigned or until he Part 32 to read: has been anthortned pursuant to j 35.14 33172 3f anufacture and distributlon 7. A new I 32.71 is added to 10 CPR (c) of this chaver te w bypmduct of redlopharmacent]rafe containing Part 32 to read: under the smem! H~ae in this byprodun material for medical noe $ 32,73 Manufacture and dietrhetam
'
- un gm*P h een**** of generators or reagent klse fee f L
* * * * * (a) An application for a specinc 11- preparation of radiopharmaermaicale conialning bypmfuce material fc) A person sho receives, acquires, cense to = = = f acture and distribute possesses, or uses byproduct material pur- radiopharmaceuticals containing by prod * (a) An application for a specific 11.- {
ruant to the general Incestse estahhed uct material for use by persons Ikensed cense to manufacture and distribute gen- < by paragraph (a) of this section shall pursuant to i 35.14 of this d1 apter for crators or ressent kits containing by- o comply with the following: , the uses lined in Group Z Omus II, pmdust mateel fos preparamm af (1) The general licensee shall not pas. Group IV, o, Group V of Schedule A. rasMopharmecuticals by persans H. t sens ct any one time, pursuant to the gen- l 25.100 of this chapter will be approved censed pursuant to i 35.14 of this chap-vral license in paragraph (a) of this if: ta for the esses listed ta Group III of ) section, a4 any one locauou of storage or (1) ne applicant satisfies the general Schedule A. I 35.100 of this chapter wtB use, o total amount of todine 125, ladine requirementr specified in d 3023 of this be approved if N m 1)- t 131, and/or iron 59 in excess of 200 mi- chapter; (1) The applicant satisSes the emeral l mcuries- (2) The applicant stdamsite avidence requirements specified in j 30J3 of .this ;
. that: chager, j e . . .
(1) ne radiophartnaceutical contah 12) 'Ibe applicant sutunits evidraan ; (d) Tha general Itcensee sha!! not re- that: ! atve, entuire, possess, or use byproduct ing byproduct material wtll be ma=arma- (il ne generator or rmemt ilt is to y miterial pursuant to paragT*ph Ial of tured. Inbeled, and packaged in accor11- - ance with the Federst Pbod, Drug and be manufactured, labeled, and t=*Med this section: (1) Except as prepackaged tmits which Cosmetic Act or the Public flealth Serv- la meeordance with the Federal Pood, are labeled in accordance with the provi- ICP Act. such as a new drug appham Drug, and Commatic Act or the Pubuc sion2 of a spectfic 11cenae issued under 'NDA) appmved by the Fbod and Drug IIcalth Service Act, such as a new drug Mmt*tration (FDAD, a biologic prod- apphcation (NDA) approved try the Food th2 provblons of f 32.71 of this chapter . er in accordance with the provisons of a uct licerme issued by FDA. or a "Noum of and Drug Adm!ntstration (FDA), a bio-Clatmed Invest 8entinnal Excenption for a laste product Heense issued by PDA, or a specific license irsued by an Agreement ttate thit authertzes manufacture and New Drug" (IND) accepted by FDA: or " Notice inf C1stmed Investigational Es-distribution of todtne-125, todine-131, t11 The manuf acture and distribu. etaptten for a New Dries" (IND) accepted cartxm-14, hydroger -3 t trttaum), or tron- tJon of the radtophannaceustical contain- bF FDA: or 59 for distribution to persoris generally ing byproduct materialle not anbject to (11) The manufacture and dAstrthustion 11oensed by the Agreement S&ata, the Pederal Food, Drug, and Cosmeuc of the generator or reasent kit are not Act and the Public IIcalth Service Act subject to the Federal Food, Drug, and i e . . . . s i NotaAt E8645TER, VCt. 29, NO,136--W5DNE50AY, JUtY ty, itM . ~. , ,
i mi m RULES AND REGULAT10NS (3) ne rep;icant subm1Ls informa-es and (Si, by amending the first PAnfT 32-SPECIFIC LICENSES TO MAN. tfFACTURE, DISTRIBUTE. OR IMPOfrT tion cn the r:dianucIlde, chemical and cntenc2 of paragraph (b), and by CERTATM TTEMS CONTAttt1MG ETPROD- physical foruz ackaging including max-ur.cnding paragraphs (c)(1) and (d) 1rnum acurity per package, and eld- ,li to read as folloers: UCT MATERIAL
- 4. The title of 10 CFR Part 32 As ing provided by the packaging of the try-131,l l Gncral licenae for use es kr. amended to read as set 5erth above. product material that is appropriate for pendeet material fee certale ha vetro 5. Secuan 32.71 of 10 CFR Part 32 is safe hand]Ing a-d storage of radb elimcel or laboreturr testims. amended by adding new fl 32.71(h) (4I phannaceuticals by group licensces; and (3) A general license is hereby issued and (5) and by amending i 32.11(c)(1) (4)(11 na label af!!ard to each pack-o any phystetsn. clinical laboratory or to read as follows: age of the radl3rharmaceutical cantaans temp 1t^.1 to necive, acquire. pom info N
.ransf;r. of use, for any of the following' $ 32.T1 Mannfseture and distrilmtime of tity, and t I asta , at t -
- tited tests,in accordance with the pro- prodwet matersal for ecstain in S W to rackage. or the leaflet or itsions of paragraphs (b), tel, (d), (e), , tra clwucal we laherminry testing brochmt which scccmp1ntes each pack-tnd af) of this section, the following by- ==ler s='ral Im*e. we, contains a staternent that the radio-
)toduct miterials in prepackaged unita: An application for a speclSc license to pharmaceutical L5 licensed by the UB. a . . . . manufacture or distribute byproduct ma- Atomic Fnergy Comm!ssten for distribu- i I (4) IIydrogen 3 (tritium),in units ng terial for use of I 31.11 tmder of th14 the general chapter license tion will be approved to perscns I 35.14 licen<ed and I 3110') Grouprursuant I. Group to H, I xcording 50 microcartes each for use in Group IV, or Group V of 10 CFR Part 35, $ n vitro clinical or laboratory tants not if' * * * *
- as appror riate. or undar equivalent 11- 1 nyolving internal or external admin 6 (b) The byproduct rnaterial is to be censes of Agrermant States or ht an ration cf byproduct material, or the mitation therefrom, to huanan betr4a or pmpared for distruen in prepacksged arp!! cation for such iteense has been ,.
units of: Died with tre Coms"leske on or before g tnimals. October 15,1974 ard in st111 pending. . (58 Iron 59, in units not exceeding 20 . e a . . (ii) ne labels, leaf! cts or brochures I nicrocures each for use in in vitro clini- (4) flydrogen 3 (tritium) in un!ts not required by this paragraoh are in addi- $
- al or laboratory testa not invohing In- excectlinie 50 microcuries eachl tlon to the labeling required by the Food l ernal or external administraWn of by- (5) Iron 59 in units not exceeding 20 and Drug Ad'ninl4raf ton (FDA) and a
.aruduct ciaterial, or the radiation there. they may be serarate front or, with the from, to hurnan beings, or anhnah microcuries cach. (c) Each prepackaged unit bears a anproval of FDA, mw t e combined with (b) No person shall receim, eagetre, durable clearly vidbtelabel: the labering rwired by FDA. l possess, use, or trarmfar bypsodset e (1) Identifying the radioactive con * (b) If an sprlic1tioen is filed pursuanb i rtal punuant to the general noesses es- tents as to chemical form and radio- to pararraph (a) af this nccho on or i tatllshed by paragraph (a) of this see. nuellde. and indicating that the amount before October 15.1974 for a license to j Laon until he has tiled fann AECAg3, of radtonctivity does not exceed 10 manufacture and distribute a red 60- "itegistration Certincate-in Vittu Test- mlC N
- d O ' W . ' M* Of pharmamu8 Leal that was 45stributed
- ing with Byproduct Material Unde Gen- cartman 141 M miemuries of hydrogo 3 commeretally ori or tvfore August is.
etalIJcense/* with the Materials Branch, ttritiumil of 20 microcuries of Iron 59, 1974, the arWicant rn*y continue the ' Directorate of Licensing, U S. AtasnAc and distribution of such redlorharmaceutical Energy Commission. Washington. DC. * * * *
- to group lacerwees until the Commisdon !
20545, and received from the Commission s valkisted copy of Form AEC-483 with 6. A new l 22.73 to added to 10 CFR tssues the !! cense or notiften the ag>ph cant otherwise. registration number assigned or until be Part 23 to rend:
- 7. A new l 32.73 is added to 10 Clm !
has been nothortred pursuant,to 135.14 33172 Alanu f acture and distribution W of this chapter te aos vw.sa- of redlopharmacenticale containing Part 32 to read: under the ameralIAcense in this bypmduct material int medical noe 5 m al-fe w helm
- - under groep liceware. of gracrators or reagent Idts fee '
* * * * * (a) An application for a specific 11- preparation of radiopharinaceuticals containins byprvJuct material (c) A person sho receives, acquires, cense to mavfarture and distribute '
.>onsessen, or uses byproduct material pur* radiopharrnaceuticals containing byprod' (a) An application for a specific W auant to the general 11 cense eseah11shed uct material for use by persons !!cenced cen;c to manufacture and dhtribute gen. I by paragraph (a) of this section shall pursuant to l 35,14 of this chapter for entory or resgent kits containing by. / comply with the following: , the uses listed in Group I. Group H* psoduct material for g6 d (1) The genersi llansee nhall not ons- Group IV, o, Group V of Schedule A* radiopharmeccutiesis by persons 11 - . seas tt any one time, pursuant to the gen- l 35.200 of this chapter will be approved censed pursuant to 13514 of this chap-nral !! cense in parugnach (a) of this if: ter for the esses listed in Grasp IH of
- section, a4 any one location of storage or 81) The applicant satisfies 19 rencral exhedule A. I 35.100 of this chapter wtB time, o total amount of todine 125,1edine requiremente specided in 3 3023 of tais he approved if (See Note 1):
131. and/or tron 59 in excess of 200 nal- chapter; (1) The applicant satisfies the sencrat wocuries. (3) The optilicant andasalto evidence requirements specified in l 30 33 of this chapter, i e . . . that: (1) We radiopharvnaceuta:a! cratsen- t21 ne applicant submits eviderre (d) 32 general licensee shall not re. cetve, tequire, possemn, or use byproduct ing byproduct material will be mamarac- that: (1) We eencratar or reagent 111 is to , mr. tert:1 pursuant to paragraph (a) of tured labeled, and tekneed in acco 13-ance sith the Federal 1%od Drug and be manuf actured. labeled, and gearneed lhls section: (ll Etecpt as prepackaged tmits v;hich Cusmetic Act or the INblic flemith 13erv- in accordance wWh the Federal Pood, are Ir.beled in accordance sith the ptvvi. Ice Act, such as a new drug applics&Jun Drug, and Cosen 44e Act or the Puhuc sions of G spectfle licence isted under (NDA) soproved by the Fond atx! Du9sg !!ealth Herttre Act, stich as a new drug Adminhtration (PUAD, a biolpute prud- appikattom (NDA) approm! try the Food th2inprovisions or accordance ofwith f 32.71 of this chapter the provisons of a uct license tisued by FDA. or a " Noti of and Drug Administration (FDA), a bio-Claimed Inve-terational Kuernption for a hate product lleense tasued by PDA. or a spectne license levued by an Agreement Ltate (n't authevizes manufacture and New Drug itNun accepted by ITA; or " Notice af Claimed Investigational Ex-distnbutt:n of todtne-123, iodine-131, ills The manuf acture and distribu- esaption for a New Drug"(IND) acocyted earimm t4 hydrogen-3 ttrttham),or tron- tann of the radiophartnacumttcal conlain. by FDd; or 59 for distributton to persons generally ing byproduct materini is an4 anbject to till The manufacture and deathlmtion (censed tw the Agreetnent S&ata, the Pederal Food. Drbg. and CosmetJc of the generstrir or reastsit kl& are not Act and the Public Health Service Act subject to the Federal Food. Drug, and . e e . . . NotaAt af46&tta, VOL. 39, NO.13 6--WESNIMPAY, JULY 41, 89te N E i
x RULES AND REGULATIONS Cosmetic ice Act. Act and the Public Health Berv- 20119 ule A, 8 35.100 approved if: of this chapter will be Nor
- 1. Although the Commission does not (1) material, the Commission will consider regulate the manufacture and distribution or eral requirements The applicant satisfies the gen- Informationited to: that includes, but is not lim-reasent atts that do not contata typroduct chapter; in i 30.33 of this material, it does regulate the use of such (26 (ti Primary containment (source cap-reagent alta for the preparation of radto- sule) ;
pharmaceuticats containtug byproduct ma* informationThe applicant submits (111 sufilcient j'M,PNt r oc ter at. "
" regarding each type of ment; Protection of primary contain-source or device pertanent to an evalua.
(111 ) uracturer or reagent alte that co not contatn (D tion The of its radiation safety,incitding: byproduct Method of sealing containment; brproduct matertal who destres to have2ta material con- terials; (tv) Containment construction ma-reagent ktta approred by the Commission for tained, its chemical and physical form and amount; une be pgroons !Jcensed pursuant to I 38.14 , : and Oroup HI of Schedute A. I S4.100 of thta (v) Form of contained radioactive ma-terial; chapter may submit the pertinent informa-tion specifted in this I 32.73. tion (gu) of the source or device;(1D . (vDDetails Maximum oftemperature design and construe withstood during prototype testa; (3) The applteant submits Informa- prototype tests to demonstrate that (vill Maximum theprocedures pressure withstood for, and nsults tion on the radionuclide, chemical and sourte or device will maintain its in. during prototype tes s; physical form, packaging including max. tegrity under stresses likely to be en- (v111) Maximum quantity of con- ' imum activity per package, and shielding countered in normal use and accidents; tained radioactive material; provided by the packagtng of the bypred- (tvi For devices con
- aining (1x) Itadiotoxicity uct material contained in the generator of a prototype device; productby. dioactive material; of contained ra-cr reagent kst; material, the radiation proft'e (x) Operating (v) experience with identi.
(4> The label affixed to the generator Detalls of quality control oroce- cal sources or devices or similarly de-or reagent kit contains information on dures to assure that production sources signed vices. and constructed sources or de-the radlonuclide, quantity, and date of - assay; and design and prototype tests:and devices (c) If an mee' theisstandards application filed pursuant of the (5) (vD Procedures to paragraph (a) The label affixed to the generator or reagent kit or the leaflet or brochure calibrating sources and and standards for before Octoberof15, deYlees; this1914. sectionforonaor!! cense to?z which kit.contains: accomp,anies the generator or re. (viD Legend and methods for label agent Ing sourcm and devices as to utelt radio--dettee manufacture and distribute a source or that was distributed commercially (1) Adequate information, from n active content; on or before August 16,1914, the ap-radiation safety standpoint, on the pro- (v11D Instructions for handling and pil: ant may continue the distribution of g' cedures to be followed and the equipment storing the souret or device from the such source or device to group licensees - and shielding to be used in eluting the radiation safety standpoint; these in- until the Commission issues the license generator or procenstng radioactive ma- structions are to be included on a dur- or notifies the applicant otherwise. terial alth the reagent kit, and able label attached to the sou (11) Efectire date. The foregoing amen't!- A statement that this generator or device or attached to a permanen*rce ,tto or
- ~
reagent kit (as appropriatel is approved age container for the source or device; ments of II 31.11 and 32.11, and new for use by persons licensed by the UE. ProWied, That instructions which are 0 Il 32.72,32
" 6, 73,'and 32.74 become effective Atomic Energy Commission pursuant to too lengthy for such label may be sum- m o 13 f ll 35.14 and 35.100 Omup III of 10 CPR m:.rized on the label and printed in gech on January 13, 35 I M me Part 35 or under equivalent iltennes of detall on a brochure 5:hich is referenced Agreement States, or that an appliention on the label: (see si,1st,1e2,183, tw t, 83 r03, as stat.
(3) for such license has been fil'd with the 935. Ms. es3. 954. as amended (42 U a c. Commission The label amxed to the source21 on or before October 15,1914 device, or to the permanent storage con-or1, 2201, 2232. 223J0 and is still pending. tainer for the source or device, contains Dated at Germantown, Maryland, this 10th day of July,1974.
'I12e labels, leaflets or brochures required Information on the radionuc!)de, quan-by this paragraph are in addition to the tity, and date of assay, and a statement For the Atomic Energy Commission,
!abeling required by FDA and they may licensed that theby (name of source or device) is be separate from or, with the approval of n n thees US. Atom!c Energy Pa trt. C. Bsween, ^
FDA, may n M pmons db be combined with the labeling censed pursuant to ll 35.14 and 35.100- Secref ary of fhe Commfuton. 1 Ifan to 1%ragraph talpp!!ca' ion is fued" pursuant g,,n nyre-1627s two 7-16 74.8 48 amt
' " " " " "IGroup##"'
VI of 10 CFR Part 35 or under
'" OI"l'8 such of this secuon on or r that a pend;ng app ^lication"for befute October 15,1974, for a licetise to manufacture and dtstribute a generator license nmw has been filed with the Com-or reagent kit that was distributed com. C ,
on October 15, IR a such la mercially on or before Augtnt c ng for swrces the applicant may continue the distribu.16, 1974, Mt nquin leg tenn stwap tion of such generator or reagent kit or (e E., go!d 198 seedst may be on a eleafl t brochure which accompanies the until the Commisalon or notifies the applicant otherdse- issues the license (b)(1) In the event the applicant Part 32 to read;8 A new i 3214 is added to 10 CFR desires that the source or device be re. quired to be tested for leakage of radio-6 32.7% Manufacture active material at intervals longer than and distrilmelon als m nths, he shall include in his ap-of murece or dnier. containing by. prmlurt material for medical we. Ducauon a d elent infonnauon to (a) An application for a specifle justifled demonstrate that such longer interval is by perfortrance characteristics heense todevices manufacture and distribute sources and containing by* of the source or det .:e or similar sources product material to persons licensed have a algn!ficant bearing on the prob-or devices and by design feat pursuant to t 3514 of this shapter for ability or consequences of leakage use as a calibration or referecce source or for the uses listed in Group VI Sched- radioactive (2) matertal arom the source.of In detertnining the acceptable in- " terval for test of leakage of radioactive
~
a a fi MottAt MGl5fft, VOI 39, NO,130--WEDN480AY , ,1974 JULY ly -
~ * .
g .
~
3210B RULES AND REGULATICNS district director unless within 30 to declare days the cardob* he applicant void j Title 10-Energy from restrictions under regulations cur-jects and demands an < 'pportunity to see CHAPTER l-ATOMIC ENERGY rently in cifect, it may become effective and rebut the adverse evidence. Any re- MMISSION without the customary 30-day notice. .< buttal, explanation or e ridence presented PART HUMAN USES OF Pursuant to the Atomic Energy Act of by the applicant shall I e included in the SY DUCT MATERIAL 1954, as amended, and Sections 552 and s 553 of T!tle 5 of the United States Code, record whether of theproceeding. 'l he determination applicant s a United States Group Ccensing foe Certain Med! cal Uses the following amendment citizen shall be based < in the entire rec- Notice is hereby Riven of the amend. Chapter I, Code of Federal Regulations, ord and the applicant o hall be notifled of ment of the Atomic Energy Commission'sject Partto35 is published as a document sub , codification. such determination. If he determination regulation "Haman Uses of Byprodt.ct is that the app!! cant is not a U S. citizen
- Material." 10 CFIt Part 35 In 135.100, paragraphs (a)(3), (4),
he shall be notified of Ihe reasons there- Section 35.100 of 10 CFliPart 35 !!sts (13) and (b>(21) are amended; para-for, and the card shall automatically be groups of medical uses of radioisotopes graph (b)(23) is renumbered (b)824); ' deemed void. No appeal shalllie from the that have similar requirements for user a new paragraph (b)(23) is added: district director's decis lon. training and experience, facilitics and paragraph (c)(3)(viii) is amended ard (3) Admission of chi nage. A U.S. citi- equipment, and radiation safety proce- a new paragraph (c)(3)(fx) is added to ten identification card shall be deemed dures. Under the procedures set out in read as follows: th , g in aP*jt tj d ef
" i 35.14 of 10 CFIt Part 35, an application 9 33.100 Schedule A. Groups of medical or a specif c Ilcense for any medical use u.cn of to product material.
Imm!gration omeer th tt he is an a!Ien of byproduct material specifled in one gnd consents therein t a the voidance of w mm of the grows in 13U00 is con
- ta) Group 1. Use of prepared radio-the card. Upon the sign ing of such state. sidered by the Commission as an appli- pharmaceuticals for certain diagnostic ment the card shall be. nrrendered to the cation for allof the uses within the group studies involving measurements of up.
immigration omcer. r groups that include the use or uses take, dilution and excretion. This group (4) Surrender of rot I card. A told U.S. 8U does not include uses involving imaging Iginy ,the
, g9qa _p tca e o mission pub- "" "" # ' # *" ** " "8' citizen identification c trd which has not been returned to the So rvice, shall be sur. I shed in the FtornAr. Hrcistra (33 fit * * * *
- rendered forthwith t< an immigration 20143) amendments to 10 CFR Part 35, (3) Iodine 131 as todinated human omeer or to the isst.mg omce of the to become effective on January 13, 1975, scrum albumin (IIISA) for detetmina-Smlet which added several new uses to the ex- tion of blood and blood plasma volume
-(h) U.S. citfren h 'enti/! cation card isting groups I and II of I 35.100 Sched- and for studies of cardiovascular func.
ulo A and established new groups III. tion and protein turnover; previously issued on F,irm I-U9. A valid IV, V, and VI of I 35.100. The f.otke of U.S. citizen identificat 84) Iodine 125 as lodinated human Form I-119 shall con .inue on card issued on propose.1 rulemaking that was published scrum album'a (HISA) for determina-but shall be subject tc the provisions of 1974 (33 FR 2384) on this amendment andoffor to be valid, in the Frnanat. Hrctstra on January 21. tion blood and blood plasma volume studks of cardiovascular func-this section. of I 35100 stated that the groups of tion and protein turnover;
$ 299.1 t Amended ) licensed uses would be amended from . . .
time to time to add new radiopharma- . . The list of forms in 1299.1 l'rcsc ribed ceuticals, sources. devices, and uses as (13) Chromium 51 as sodium chromate forms is amended by deleting therefrom # for determination of red blood cell vo!- The u o of I the reference to "Fortn I-li3 (1-1-13) l'odine 125 131 as 1:dinated htunan sertun albumm and fodine ti$[e"and rol t in ! Io. ' Identification Card to *
- in the United States." Resident Citizen <!HSA) for studies of cardiovascular * *
- function and protein turnover, (2, (b) Group II. Use of prepared radia-(See.103 es stat.173; -l U.S c. 1103) thromium 51 as rodiurn chromate for pharmaceuticals for diagnostic studies studies of gastrointestinal blood loss.13, innolving imaging and tumor locahza-The basis and purtose of the above- technetium 99m as labeled sulfur colloid Il003-prescribed regulations are to modify the for bcne marrow imaging, and (4) tec h, a + e e
- current procedure ofit Ltdng two different netium 09m as labeled stannous pyro-types of United Statea citizen identifica- phosphate for bone imaging have be- (21) Technettum 90m as labeled su! fur tion carda (Form I-ti I and Form I-197) come well established chnical procedures imaging colloid *-for liver, spleen, and bone marrow and radiopharmaceuticals for these uses to provide for the ts. 'tance of a single have been approved or licensed by the * * * *
- type of citizen identification card, Form Food and Drug Administration. Section (23) Any byproduct material in a I-197; to specify the Fligibility require- 33.100(c) (3) authorizes the ute of re, radiopharmaceutical prepared from a ment.s and procedure for applying for s' egent kits for the preparation of, and reagent kit listed in paragraph (c)(3) of ,
card, or a replacemet t card, as we!! as the clinical me of, cert.dn radiophar. this tection for a use listed in that + tha conditions for su render and vold* maceuticals. M order that medical in:.ti, paragraph; tutions and physicians may obtain thcee pp ance of the card, (24) Any byproduct material in a radiopharmaceut!cals in prepared form radiopharmaceutical and ior a diagnostic In accordance ' wI th long standing it om radiopharmacists instead of making tise involving imaging for which a No. practice, and as exp1 citly ret forth in their own preparation from renent kits. tfee of Claimed investirtional Eens- g 123510(a), the Unr rd States citizen the radiopharmaceuticals prepared from tion for a New Drua s !ND) has tacen Identification card w 11 continite to be som:ent kits listed in 133.10Fe)(3) w ill accepted by the Food and Drug Admin-te added, as prepared redlopharmaccuti, htration 'FDA), , made available solely orthe convenience cats, to 135.100(c) (2) . * * *
- cf those United State < citizens who wish /n editorir.,1 correction is also made
- to apply for it. Posses Lion of the card is in i 35.100(c)(3)(vill) to authorize the (c) Group Ilf. Use of generators and not mandatory for any purpose. use of distannous etidronate complex for reagent kits for the preparation and use E#cclit e date. his )rder shall become b ne imaging. instead of disodlum etidro- of radhpharmaecuticals containing by-effective February 19, l975, " " ' product iraterial for certain diagnostic p d. ',
Dated: January 14.1915. Decause this amendment relates solely
!* F. C Har u4 w. Jr., y$[f (3) Deagent kits for preparation of Commissioner d Immigrattort d a 'a e ir technetium 00m labeled:
and Nafkrahaaffon. omitting notice of prop 3 sed rulemaldng, * * * * ' and pub!!c procedure there)n. as unnee- (villi D! stannous etidronate complex [FR the,75-1697 Flted 1-17-73.e:45ami euary. Suve the amendment teltcycs for bone imagingt tiotaAt a!Gilf tt, VOL. 40. NO.13-MONDAY, JANUARY 20, IMS 1 =
y RULES AND REGULATIONS 3210( (ii) Starinous pyrophosphate for bone activilles be rrescrib Ed and accomplished I. cum nca on Qua' tty Assuranco Require imaging. In accordance with written instructions nn :ta Durtnt Design and Procurernent Pham
. . . or procedures, also requires additional ct Nuclear P wer Plaav , WASH-12E3, Re ggggg g _sgg y assurance of quaht:' to be provided by t1ston I, dated May 24, 1974; N 95 0ffeC M M M . M M Verification of the ' orrect performance 2. Ouldance on Quality Assurance Require mants During the Con d 'ruction Phase ol e 1 1. Pub. L. 83-703, e8 Stat. 048 (42 c ec n, ei i g, inspe i g, es in ,
- and auditing. Execu ton of a quality as- my t0, 74 an Dated at Bethesda, Md., this 15th day surance prc:: ram t hich complies with 3. outdance on Quality Assurance ReWre of January 1973. ments During the op rations Ph a se a For the Atomic Energy Commission, Appendix B thus in olves both the per- Nuclear Power PMnts," WASH-123 5, dated
' formers; e e, dest ner, welder, power october 20, 1973.
L. MANNING AftTNTEINc,
- The comments on t:le notice of pro-Director of Regulation, Irn Due.75-1831 FHed 1-17-75.8:45 am]
MI"
$" *," fun Uo inspector, or tester.
i . posed rule making,in r eneral, supported the concept that the C >mmission should One of the mattirs with which Crt- be flexible in determir ing acceptability
" ar=5= fa?== y@y"fyd'g y!""y 2 "*Mf3*d"r$ 555 Quality AssuranceC iteria-Permtssible ,
assurance functions af (1) assuring that and delineates the fu !ctional relation-Organizational Relationships
' the quality assurance program is este,b- ships that are a part )f his quality as-On Aptd 19,1970 the Atomic Energy lished and execute r and (2) verifymg surance program, Commission publisil ?d in the Frotut that an activity has. been correctly per. Additionally, comm 'nts stated that Rrcrstra (39 FR 13: 70 for pub!te com- formed. C11terion I now requires that Criterion I did not c!ca rly state that the ment a proposcd an Pndment to 10 CFIL such perrons and organizations shall execution of the qualf y assurance pro-Part 50, Appendix D "Qualit) Assurance have sumclent auth) city and orgamza. gram involved both th r performers who Criteria for Nuc!cai Power Plants and tional freedom to id:ntify quality prob. achleve the quality o!'Jectives arrt the PJet Reprocess!ng I' ants." The purpose tems; to initiate, recommend, or provide veriflers who assure t aat the rcouire of the amendment is to clarify the intent solutions: and to vc -ify implementation quality objectives hase been attained of gard Criterion I, "Orr inization " with re- of sclutions. The int?nt of these organi. As a result of valid 'riticisms in this to permissible 3rganizational rela- rational requiremen tionships. Allintere' ed persons were m- those persons and s is to assure that legard, Criterion I ha ; been revised to vited to submit ecm : lents or suggestions forming quality assu organizations per. Indicate that activiti ?s affecting the ance functions have safety-related function in connection with t le proposed amend- the required de:;res of freedom frcm performing functions iinclude both the
, ment by June 3,197 L other organization 11 respon.sibilities, assurance functions. C, and the quahty The prolmed an endment was pro- such as cost anri sch 'duling, w hich could been revised to inclut iterion I has alao posed as a result of the questions raised conflict with their e a requirement by the decision of tP ' Atomic Sifety and functions. quahty assurance for e.stablishment an I delineation in Licensing Appeal 1 card in Common- writ!ng of the author ty and duties of It was recognized tecalth EJ! son Co. i MS4le Ccanty Nu- or,Tanizational requi in establishing the those responsible for Attaining quality efcar Station Units and 2) ALAlbl53 I that the degree of aments in Criterion objectives as well as hose perfornutig RAI 73-10, 821 (Os separation or inde- quality assurance functions.
ober 19,1873) and pendence of the pe:scus and organiza-Consumers Poicer Uridland) ALAd-l17, tions priforming quMity assurance func- Comments also ree )mmonded clart. RAI 'l3-9, f 36 dept, mber 18,1973), (re- tions can affect theh a ability to carry consideration den!( .1, ALAB-152, RAI these functions. Whl3 it is desirable from ance functions" and "d out e ani ..qu yam-+ 73-10, 816 (Octolm recting and man. questions concerned - 5, 19731), There one point of view to have persons and aging the quality ass: rance program." , relationships where personnel the organizational organh:ations perfor ning quality assur- Clarification has been accomp!!shed by I perform. .mee functions comp ing a quality assurar ~e function reported caniza tion ~.!!y, etely separated, or- defining quality assur. nee functicns as to a field project 1: from individuals who tendent who was c anager or superin- have s!<;nificant res )onsibility for per- (a) assuring that an n;'propriate quality the single project ti mccrned with only formance of the wor ; (in:!uding but not assurance program is established anzt I I assigned and had c. which he was then ihmted to cost and schedule responst, effectively executed, r id (b) verifying sponsibility for thro 3roject. st and schedule re- litlity), that same ser trathn may in some that activities affecth g the safety re-Instances hinder th t , quality assurance lated functions have la en correctly per-i i ance Appendix B estat requirements 1shes ar the quality design, assur. con. their perrons functionL Theand organia tions in perfctming formed. Since the o greater the inde-I l struction, and opero tion of those struc- pendence or separati m. for example, the quality assurance prog, am ins tures,power clear systems, plantsandti components of nu- more dimcult it m: y be in some in- the performers and ihe verifiers, the < id fuel reprocessing stances to rnalntain 1mes of communica. phrase " directing anil managing the plants that present ;r mitigate the con. tion in identifying 4 tahty problems and quality assurance pror ram." w sequences of postul;ted accidents that initiating corrective tetton. A number ol pears in the last set tence, has could cause undue r! 'k to the health and variab!cs affect the estab!!shment of a safety of the nub!!c rhe pertinent provi- quality wurance 0: 'anl7ation that will changed to " assuring o fective execution sions of Appendix 1 apply to all ac. be conslent nith C healm L The sar- OI Y IOIIIUU OIIh* I"#IAlY U'UIUUCU i l tivitics which nt!ec the safety-related tables include, but ar ? not limited to, the D N f3HL" j functions of such -tructures, systems, size of the omantz tion, 's organiza. and components. Comments aho recc nmendcd clarifi-The intent of ti. . quality assurance performed, tional st ructure. the twe of acthity being cation of the last senience of the pro. criteria prosided !!1 Appendix D to 10 where the work and is the I? cation bei ur or locations posed rule to ellmlnat t the impHeation rerformed. i CFR Part 50 is to equire that all ac. Outdance as to D 1plementatfon of n that only one individu I may be respon-I ttvities affecting the rafety related func. quahty assurance pri gram that includes sible for the quality n'surance program I tions of nuclear fac lity structures, sys, the concepts embod ed in the amend- at a given location. A. a result of this tems, and compone:its be accomplished ment set forth below is* contained in the comment, a change h ,s been made to in a systematic anc controlled manner following rub!! cation n so LEat there is n h gh degree of assur- permit the situation wl 're, at a locittion! I ance that these act!,ities are performed i These documen ts nr i available for inspee. e g, coastruction site o ' engineering and ) correctly. Appendix ll, in addition to re* tion at the commissui's Putine Document procurement building, there may be quiring that these ncthities be per- arcs uwm. r:1711 street, b w., wasnington, D c. cop:es mn be oMalms from the n.- more than one ind!vich,al retponsible for formed mannerinsuch a systen as byatic and controlled requiring that thettoust Tccinicat infor mtion Fervee. 5295 assuring effective exec 1l tion of different Port nopt ncad. Sprirgnekt. Virginia 22151. port!cns of the progr; m. It shcuId be Ptof tat RIGl$i(4, Vol. 40, NO.13-MONDM, J AN'., At1f 2 A 1 1
t( 1 N mt (Q_ RULES AND REGULATIONS
$ 78.13 3fmliffrJ <
i rtified trueritosis Title IO-Energy areas. actors are utilizt.tfon facti!ttes heen<cd (a) All States of t),e Urdted States are CHAPTER l--NUCLEAR REGULATORY Under that part, while the NRC's aut hor-hereby des!gnated a' Modined Certified COMMISSION ity our the **fac!Uttes" in the 1stter two Bruce!!osts Arcas 'xccpt Afasissippi, ENERGY REORGANIZATION ACT k fdbes I" # # " "*I Oklahoma, and Texa; . Revision of Chapter i To Reflect . Mce those are n'ot pro- 0 (b) ne fo!!cwing States are hereby Organizational and Procedural Changes duction or utillration fac!!!ttes sIthin designated as Efodif1 'd Certined Brucel- the definition of tho<c terms in the losis Areas except for the counties 'On October II,1974, the Energy Re- Atomic hergy Act Operators of GDA-named: ce du (1) Effss!ss!ppi en organization was enacted?Act ThatofAct l974 Pub. I 93-438, abo!!shed the h"' 33c fg es rat e t an as pt Rankin RDk (2) Oklahoma ex ept Adair,County. Cana* Atoinic Energy Co*nmission and created contractors " e dian, Cherokee, Hasi .11. Le Flore, Okfus- a new agency, the Nuclear Regulatory isting exemptions for certain I kee, and Pottawatomk Counties. Cbmmission (NRC), to whleh was trans- AEC, con ractors from licming lequire-(3) Texas except ' Anderson, Dallas, ferred the licensing and related regula-Freestone, Hill. Jim Wells, Kaufman. tory authority of the Atomic Energy e DA gc ntractors, and a provision for r Lina tone. Nas arro, Orange Smith, Tar- Commhr!m undct the Atumic Energy Act e rant, and Wise Count es. of 1954, as r, mended. The En2rgy Reorga- ] crs in ap-(sets. 4-7, n!zatfon Act also added, in section 202 Part 7. Advisory Boards has been re-3 stat. 32, as ame nded, seca.1 authority for the NRC to !! cense and reg- Tised to reflect the prov,isions of the and 2. 32 stat,. 791792. as arrended; see. 8, ulate certain facilf ties owned by, and cer- Federal Advisory Committee Act (8G Stat. si etat.1265, as amer ded. se- 2, es stat. CD3, and seca. 3 and 11. 76 Stat 130, 132; tain aethities conducted by, the Energy 770). Afinor corrections to Chapter 1 Research and Develcpment Administra* Ns s , s7 iets.' 7, 8 "
- havePart 9,also Publfc R been made'ecords
, has already 19141* o cra te.te)* gt Ac
- e The ERDA facilitjes and activities- of Information Act Amendments (Pub.
Efe' ffre Date: Tir foregoing amend- identined in section 202 are: L. 93-502) and tho Energy Reorganiza. ment shall become et ective on March 3, 1. Demonstration Liquid Afetal Fast tion Act. 1975. Breeder reactors when operated as part Section 301(b) of the Energy Reorgan!- The amendment i nposes certain re- of the power generation fac!Ilties of an aation Act of 1914 proildes, in substance strictions necessary ty prevent the spread electric utility system, or when operated and as here pcrtinent, that the prod-of brucellosis in catt e and relieves cer- in any other manner for the purpose of sions of Chapter I of Title 10 of the tain restrictions pre ently imposed. It demonstrating the shitability for cont- Code of Federal Regulations are to con-thouldtobe order made effi ethe promptly in meretal application of such a reactor. accomplish tinue in effect untAl modified by this its purpose in the 2. Other demonstration nuclear re* Commission. The primary purpose of the public interest and io be of maximum actors, except those in existence on Jan- technical and conforming amendments i benefit to persons sut ject to the restric- uary 19,1975, when operated as part of set forth below la to rcffect wording, tions which are rc!!eled. It does not ap- the power generation facilities of an elec* organizational and procedural changes pear that public participation in this tric utility system, or when operated in effected or reade necersary by that Act.
'rulemaking proceedin; u ould rnake addi- any other manner for the purpose of These amendments, therefore, are pri-tional relevant information available to demonstrating the suitability for corn
- marily for the convenience of licensees, l the Department.
Accordingly, under the administrative meretal appIlcation of such a reactor. interrenors, gnd the interested public.
- 3. Facilities used primarily for the re* Adoption of these technical amendments '
procedure provisions of 5 U.8 C. 553, it celpt and storage of h!gh-level radio- does not reflect any judgment by the is found upon good cause that notice actJte mastes resulting from licensed Commission on the merits of the exist-6 and other public pro <edure with respect activities. - ing rules and is, of course, withut prel-to the amendment arc impracticable, un. i 4. Retrievable Surface Storage Facil!* udice to modification of those rules by 1 necessary, and contmry to the public ties and other facilities authorised for the Commission in the future. Rese interest and good cau'e is found for mak- the express purpose of subsequent long- amendments will not affect any proceed-i ing it effective publication in theless Fz than 30 days after term storage of high-level radioactive ing pending before the Atomic Energy rtr.At Rtctsrta. waste generated by ERDA, ahich are not Commission on the effecttre date of the Done at Washinst 'n* D.C this 25th Wed i T. W STe P8 .N & Energy Rmrganization Act of 1974. Fbr T day of February,1975' developrnent activities- these reasons, the Commiss!on has found he amendments act forth below re. that notice of proposed rule maktne and Pmhr A. CHAtorx. - flect. In Chapter I of 'I1tle 10 of the Code public procedure thereon are unnecessary
' Actina Deputa Administrator. of FYderal Regulations, the division of and that good cause exists for making Veterinary ferrices, Animal the Atomic Energy Commission into two 1975. the amendments effecthe on March 3, and Plant f1co!!h inspection ~
Serrfce. separate agencies, the organization of , the NRC, the !!cer. sing and related regu. Pursuant to the Alom!c Energy Act of 1 [rn Doc M-5402 ycn 24845,8:45 am) ~J latory authority of the NRC as to cer- 1954, as amended the Energy Reorgan-
- 12ation Act of 1974, and sections 552 and -
' tain the ERDA facilities prohibition andser against activities, and 553 of Tide 5 of the United States Code, diAcrimina.
suscNArttaOrous e-vinusi s. stnuus. ToIINS M'DUC TS, ORGANisWs tion in 'Ilde IV of the Energy Reorgan!. the following amendments to 'Ittle 10, '., l Nga Eatlon Act. A separate document, pub- Cbapter I of the Code of rederal Regia-
- PART 113-STANDAPD REQUIREMENTS 11shed almultaneously in this tasue (40 lations ject toare published e.s a document sub-codification.
FR 8794), establishes the regulations of Misca!!sneous J mendments the Energy Research and Development 1. 'Ihe title of Chapter I of Title 10 is Correc fon .' - Administration in 10 CFR ChapterIII. changed to " Nuclear Ikgtdatory Com-rntssion".
. In FR Doc. 74-30053, appearing at page It should be noted that the NRC's su-44712 in the issue for thority over reactors within the first two PART O-CONDUCT OF EMPLOYEES 27,1974 and corrected aPrlday, December t page 6476 in the , categories specified in section 202 La re.
- 2. The terrn AEC"is arnended to read issue for Wednesday, F'ebruary 12,1978* flected in Part 50,"L1 censing of Produc-( make the following er ange: tion and Ut!!1zation Pacilities," since re- *NRC" wherever it appears in Part O and the term " Atomic Enerfy commts- ,
f g 13.1N. the alon"is amended to read Nuclear Regu.
- fe r e c 1 in a ne esecuts' date of no Energt Reorga- 1 story Cvmmission" wherever 11 Spp line elght should rest "Id)(D ". nizapa Act of IM4 is January H, IM8. in Part O, " , _
-' . , - - ; n
. _ }
_ y - , ._ _ y g MDERAL ttCittn, Vol 40, NO. 42--MONDAY, MAeCH 3,1978 .
.. -f 4
B. O J ~ s . 3
M SULES t,l D F m'Mims g t 7.2 50 t b oa J) r; c. !:cn r:nd DJo:u w:.t" rt c h In 12 2 'f. n foc.' note L( coded
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g;g 1.. e 1, as W , + 1 ) 811D nnd #d $ '4 s ettil FART 35-EXF07T A'.*D IMPOGT Or r.It amtr2ded by c' tic"ng tlc t uds af t(r ~ gg gj, ,DJCT f/ATERI Al. ('2J0 [ A m. en ftJ ] tht dr te " August IC.1974"rnd rub t!!ut- U~h. . E: tum 'Dacetor of Lf;&ing, h In f 32.70(c), a footnote is added ing *on uhkh bppik.. tion the Atomic rn. t Atc..n!c Enc:gy Con.mt ssion" 13 r.!tc. the colon fo!!ating the u ord " pack. CU Comm!"fon or the Nuc! car Rerula. .h. ,c. rcd to "D'rc,etrar of Nucicar Matc rial tay Commb:lan or t!,e Artccr:ent State ty
.n d Ea s uards. U.S. Rut h ..r
- c" to read os fo:la s:
p ;.&rme emcs n ,:xd * : der ! M 70 has (1Lil not ru-tr d." cnd ram n nhs tbi12) .N ETf tory Co:nminion". the 1"?crs T. r nd itp 3) sim s.n it .i cd to f(ad nLC , are chn n;< d to ' NT:C". t.nd the p - to .'a n u .rr 19 in cay to.r IN' e icows: sue r W. t y t!.e ric a ns in erect (n $ . !! Sp. .Ge lo. i n .. . O code '20M5" is chantcJ to 'wn5" (. . r e e rt.nn t b icter they appear in Part 36. A: t.ary 1.1H5. i . g 32.71 [AnnnJ.J) rar c; . e.f
- U*'1
- im s% el n-< - of I. ; n.Jue s ! ^36.ll ( Anu nJ< J) h In I 32.71(d), a fc:tr:te !- f.dded y In i 36.!! the semic:!cn and u c1ds (b) ** *"
af ter the co:on follor ing the v ord "g.ck. (1) ... s&c" to read r4 fo:Jows: C Section 36 2 is rerbed to rc.,d as (21 Tor Grcup III. no licentce shall Js:
*Warta111a to January 19.1975 r.mt ur.; !a',c:s nur bear 7 section aut*cr. 32 71 prior reuh e, pc.5:Us. or use gent rators or { 36.2 Conim unica e
-by tne re.,ulations in erect on January 1, reannt }:!ts ccrJn!ning tJfrcduct ma.
(a) terial or shall we rcere:it kits that do All ecmmunicat!ons end ic* -ts 15 32.72.32.73,32.74 not centnin byprcduct rn.9terial to pre- (C:.ccrr.ing the regulations in this part i Ann nJcJ] p.ne rad %phat m uut!c Is cc ntaining shou'd be addressed to the D?rc:tc; of h Paragr.whs 3212(a)(b (1), 226 U " C Pl; Nu:Icir Material Safety end Safeguards, U S. ea
- W fm and 32.74(a
- f'3) are amended
* * * *
- Nuclear Paulatory Cc:nm!!eion, by chenrtng the r ords *Ccmmitrion en W: 'hincton, D C. 20555.
( 111 1 Generators or reagent kits that (b) ConunurJestions and reports rnay c-r Idre" to Atonne Energy Ccmmis. the manufceturer distributed on or be. be de?hered in person at the Comm!s-rien en or before~ fore At: gust 16, 1974 for which an app 11 s ton's oCces at 1717 H Street. NW u.tlan for license or t.pp;cial vr.s fJed Wuhington, DC. or at 7920 Norfolk with the Atomic E'nergy Commissien Ater.ue, Bethrsda, Mar 3:and., rant 33-STECirlC tfCEriSES OF BROAD pu:suunt to { 32.73 of this ch:pter or E20PE FOR DiFRODUCT MATERIAL uith an Agreement State pursuant to gg 3r,.21 36 36.23' and 36.28
& 33'1**
- I'i"""'!'J ] equiva:ent State regulatic,ns on or bc-fore Mnh ndd""*
O Eection 33.12 in 10 CFR Part 331s October 15, 1974 on wh!ch appliention ? The rcneral!! cense desfenationa in rrr. aded by changing the s ords " Form the Atomic Energy Commission or the !! 21(a) and (b), 36.22(a) and (b), AEC-313" to read " form NRC-313". Nuclear Regulatory Commlrston or the 36.03. and 36 24(a) and (b) cre amended Agreement State has not acted. by chaa:Ing the letters "AEC" to "NEC". . (3) For Grcup VI. no licensee shall PART 34-LICEf4SES FOR RADIOGRAPHY recette, possess or we byproduct mate-AfiD RADIATION S UETY R EQUIRE, rin.! cxcept as contained in a source or FART .!O-LICENS!f!G OF SOURCE MATERIAL MU4TS FOR RADIOGRAPHIC OPERA. device that has been me n u'a ct ured. ygong ~7 The citation of authority follow-lateled, packaged and distributed in ac. (33.3 [ Amended) cordance v ith;
, in ne tab:e of contents of Part 40 ts
, , , , remd to rcad as ic!Iows:
G4 Section 34.1 in 10 CTR Part 34 13._cnded by charginr the term " Form ( 111 ) An app!) cation filed with the em h c2, cs, et, es. set.1a2 AECw313R to Form NRC413R . Atomic Energy Commission pursuant to [8 l:,k th,$#52, 3 " g 3h23 [ A mended] I 32.74 of this chapter or uith an Arree- . is[, ment E:ste pursuant to equivalent Sinte not r22. :"33): sees 202,206 sa stat 1244, O'4s In I 34.25, paragraph (d) is regulations on or before October 15,1974 noted. 1246 g4: c s c. t,842, 5849) unicss othermsw rmended by changing the addrets *Di* for a license to manufacture a source 4r sect.on 49 40 abo Lssued under ace 184. c8 rcetor of Licens1 rig. U.S. Atom!c Energy device that the applicant distributed t e 4. as amended 42 Us c. =34. For Commission. Washington, D C. 20545" to commercially on or befcre August 16 m puwn et see. 223. Es stat 958, as Dh cetor of Nuc! car Material Safety and 19 4 on which application the Atomic Nr 6;feguards, U.S. Nuclear Regulatory Energy Comm!r.!on or the Nuclear Regu. . S . 'G)c. C:m:niss on, Washington, D C. 20555" latory Commission or the Agreement (b) andunder g 3 40.23te)(3) 40 el and 40 c2 smied sec.161o., ce stat. 953. as a:r.cnded; and by changing the term *Atornic State has not acted. 42. US c. Col (o). Tnergy Cornmission Regulatory Opera- g 35.14 [ Amended] tioru" to
- Nuclear Regulatory Commis. h In I 35.14, paragraph (b)(2H1) is ' m ne tenns " Atomic Energy Com-Men's Inspection and Enforcement". ." "AEC and the zip code L 31.31 [Amendall ammded by changing Commission" the tords or to "the Commission "the the*20545" latory Ccmmission are changed to "Nucler.r
,,NRC and 20$55. Regu; h In 134 31, paragraph talt2) Atomic Energy Commluton", paragraph resperttvtly, where they agpcar in Part is (bit 5)nti is amended by dcleting the 40, except as otherste indicated.
r.mmded by charging tt.e terru "AEC s ords after the sord "htm" and by sub-1;ccnsets)" to *-NRC limucis)". stituting the mords "by the Atem!c En- ,7 In f 40.1 of 10 CFR Part 40. para-ergy Commission or the Commiss!on;*, glaim ib) is revLsed to read as follows: ,
- PART HUMW USES OF and paragraph (fMI) is amended by E AI I" 'I""#'
UCT MATERIAL changing the 3ords "or an Agreement * * * ' ' h ne terms
- Atomic Energy Com. Agreement State" to ", the Commission, or an State". (b) The regulations contained in this mission', *AEC", and " Regulatory Op- 5 31.31 [ Amended) part are issued pursuant to the Atomic erations" are chanred to
- Nuclear Regu- Energy Act of 1954, as arr.cnded, (68 latory Conunission", *NRC', and "In- 150 Section 35.31 is amcnded fy . Etat. D19) and Title II of the Energy Re.
ch iging the term Director of IJcens. organitation Act of 1974 (88 Stat.1242), i FfDERAt Rf Cilff t. YOL 40. NO. 4 2-MONDA Y, M ARCH 3,1973 l l
s 1- - M32 PROPOSED RULES NUCLEAR REGULATORY COMMISSION [10 CFR Parts 31,35, and 40 ) l ItEPORTS TO THE COMMISSION CON- 'l CERNING DEFECTS AND NONCOMPLI-ANCE Proposed Requirements he Nuclear Regulatory Cornmtaslon l has under consideration amendments to l 10 CFR Chapter I, Parta 2,31,35, and 40 of its regulations and the addition of a new Part 21 to its re.ulations. Part 21 would be entitled " Reporting of Defects and Noncompliance **. . The purpose of these proposed amend-ments is to implement section 206 of Pub. Zu 93-438, the Energy Reorganiza-tion Act of 1974. Section 206 provides as follows: NoNeoapLlaNca Section So6(a) Any Individual director, or responsible ofBeer of a firm constructing, owning, operating, or supplying the ccm-ponents of any facility or activity which is 11 censed or otherwise regulated pursuant to the Atomic Energy Act of 1954, as amended, or pursuant to this Act, who obtains infor-mation reasonably indicating that such fa-cility or activity or baale components sup. plied to such facility or activity-(1) falls to counply with the Atomic Energy Act of 1954, as amended, or any applicable rule, regulation, order, or license of the Com. mission relating to substantial safety has. ards,or (2) contains a defect which cosld create a substantial safety hasard, as defined by regulations which the Commission aball promulgate aball immediately notify the Commission of such fhilure to comply, or of such defect, unless such person has actual knowledge that the thenminalan has been adequately informed of such defect or fall. ure to comply. (b) Any person who knowingly acd con. scaously falls to provide the nouce required by subsection (a) of this section shall be sub) set to a cir11 penalty in an amount equal to the amount pentided by section 234 of the Atomie Energy Act of 1964, as amended. (e) 'De requirements of this section shall be prnantnantly posted on the premises of ( any facility incensed or otherwise regulated pursuant to the Atomic Energy Act of 1954, es amended. (d) 'me Commisalon is authorised to con. duct suct reasonable inspections and other enforceNt.t activities as needed to insure saapuance, with the provlssons of this section. De proposed new Part 21 of this chap-ter and the proposed amendments to Parts 2, 31, SS, and 40 are intended to < implement section 206. Canments are particularly invital with respect to the definition of " responsible odReer" in proposed i 21J(t), %16 de8ni-tion would specify those persons who would be obligated to report defects in basic componente and failures to comply with applicable requirements. The legis-lative history of the Energy Reorganiza-tion Act of 1974 makes it clear that the section does not reach all employees with knowledge of a defect or non-com- i' piiance-es., artisans doing construe-tion work-because the Senate provision expressly covering " employees ** was changed by the Conference Committee sesetAL asseste, vel 40, peo. es--ascoe47, aMACM 3,1975 J
s' l . PEOPOSED RULES 8833 to
- responsible omeer". (See H. Rep. 93- or any applicable rule, regulation, order, (4) Any condition or circumstance 4 1252 on H.R.11510, 93d Cong. 2d seas or Itcense of the Commiuton relating to involving a basic component that causes.
- p. 36.) The definition of " responsible om- substantial safety hazards: or (b) defects or contributes to, a safety limit, as de.
( . r.er" as now proposed would extend to in any such facility, activity or compo- finert in the technical specifications of a ibld personnel with manasement au- nents which could create a substantial facility license issued pursuant to Part thority who should have prompt knowl- safety hazard. 50 of this chapter, being exceeded. edge of defects, such as project managers g M.2 '%p6 fe) " Director" means an individual and chief quality asrurance personnel. who is authorized to manage and direct Pursuant to the Atomic Energy Act of The regalations in this part app!F. the affairs of a corporation, partnership 1954, as amended, the Energy Reo.gani- except as otherwise provided in this part or other bu<tness entity. sation Act of 1974 and nection 553 of title or Parts 31. 3S. or 40 of tnis chapter, eg, " Firm operating" means any indi-5 of the United States Code, notice is to each firm, rond eacle ritrector or re* vidual. corporation, partnership. or other hereby given that adoption of the follow- sponsibic octeer of a firm, einstructing- mttty eneaRed in the operation of a ing amendments to 10 CFTt Chapter I. owning, occrating nr supNpng basic facility or the conduct of an activity Parts 2. 31,35 and 40 and the addition of comgnents of any faculty cr und in which is subnct to the licensing require-O new Part 21 to Chapter I are contem- any activity licensed or otherwhe reiru* menta of Parts 30, 40, 50, 70 or 71 of plated. All interested persons who desire lated pursuant to Parts 30, 40, 50, 70- this chapter, to submit written comments or sugges- orilof thischapter. iri " Firm ownmg" means any indivi-tions for consideration in connection with 6 21,3 Definition *. dual. corporstion, partvership. or other the proposed amcradments and new Part entity that povestes a legal right to use 21 should send them to the Secretary, As used in this part, aM enjoy property, including the right U.S. Nuclear Regulatory Commirston, ta) "1bsic component , means any to transmit it to others, used in a facility Washington, D.C. 20555 Attention. component, structure, s> stem or con- or activity whteh is subject to the licens-Docketing and Service Ecctlan, by assy 2. stituent part ther-of, smpolled for er ing requ!rements of Par *.,s 30,40,50,70. SMS. Copies of comments on the pro-to utilir.ed in a facility the licensing or r,ctivity recceanents ofsubject Parts er (h) 71 M M chapten posed amendments and the proposed new ** Procurement document" means part may be examined at the Commis. 30, 40, 50, 70, or 71 of this chapter in any contract that defines the require-ston's Public Document Itoom at 1717 H which a defcet or f ailure- to com91y with ments whir.h items or services must meet Etreet, NW., Washington, D.C. any applicable regule.tton la this chan- in order to be considered acceptable by The proposed amendments would read ter, order t.r liceme issuad by the Com- the purshaser. mtulon could create a substaritial cafety (1) *Responsibic omeer" means the as set forth below:
- 1. A new Part 21 is added to read as hazard. president, vice-president anti others who follows: tbl "Commizzion" means the Nu- are vested or delegated with power of clear Regulatory Commwlon M lts dufy executive authority or manuement au-PART EPORTS OF DEFECTS AND eu d rep NONCOMPLIANCE OsNNI. PtoNNs f t o o
- rm construct-ing" meat'& any individual Corporation, h "r .3ubstantial sdfety hazard",mean g3 partnen. hip or other entity engaged in f gg the design, manufacture, fabrication, a r,iskDof anyexposure of the following:
SU scow placement, crection, installation, mod 1* The (1) of the whole body cf any incitvidual to 25 rems or more (' 212 Denniuons. 21.4 Interpretations. fication, irgection, or testing of basic of radiation; (11) of the skin of the whole sia communicauons. components. bcdy of any it.dividual to 150 rems or 2t 6 Poeuas of regulauona. id) " Defect"means: more of radiation; or (111) of the feet. Nortriemos (1) Any deviation in a basic com* ankles, hands or forearms of any indivi-ponent, supp!led to a purchaser, from: duni to 375 rems or more of radiation. 21.21 NotHicauon of fatlure to comply or Perkrmance spechaMons, M entstance of a defect. (2) 'Ihe release of radioactive ma-(11) Design criteria or terial in concentrations which if aver. Pm marism D rnsaww (11D The normally expected per- seed over a period of 24 hours, would ex-21 31 Procurement documents. formance or lifa expectancy of the ceed 5.000 times the limits specified for tworsernows. Recoens component in the eervice for which such materials in Appendix B, Table U, intended, as specified in either (A) Part 20 of this chapter. Ins n the procurement document for such sk) " Supplier" or " firm supplying 21 jt, ga *nes of records. component or (B) the application for componenta" means any individual, cor-A n nostrv: Seen 161, 334. 98 Stat. 948. as license to -construct er operate any poration, partnership, or other entity amen d. es t 444 e4 c sso 22s2); facility or conduct any activity subject identifled as contractually responsible
*
- to the licensing requirements of Part for delivery to the purchaser of a basic GewmaAL Paorissous 30, 40, 50, 70 or 11 of this chapter. component used, or to be used, in a
$ 21,1 Purpose. if such condition could create a substan. facility or activity whleh is subject to the licensing requirementa of Part 30,40,50.
The regulations in this part estab. tial(2) safety hazard-
'Ite installation, use, or operation 70 or 11 et this chapter-llah procedures and tmplementation requirements of section 306 offor of any basic component in a facility 5 21.s Inierprei iion .
the Energy Emrganisatlan Act of subject to the licensing requirements of Execpt sa specifically authorized by 1974. (88 Stat. 1246). That section of this section; or the Commission in writing, no interpre-requires any individual director or (3) The installation, use or operation tation of the meaning of the regulations responsible ofilcer of a firm construct- of any beste component in a faelv!!ty in this part by any OScer or employee of ing, owning, operating or supplying the subject to the licensing requirements of the Commission other than a written in-components of any facility on activity Part 50 of this chapter if such component terpretation by the General Counsel will which is licensed or otherwise regulated was not destrued, fabricated, erected. be recognited to be binding upon the pursuant to the Atomic Energy Act of constructed, tested and ir.spected as re- Comnusalon. 1954. as amended, or the Energy Reor- quired by I 50A5a of this chapter or in O'"" U "I I** genitauon Act of 1974, to notify the Com. accordance with the procurement docu- 0 2IA Except where otherwise specified in mission of information reasonably indt- ment for such component, or the app 11 cating f a) failure of the facility, activity cation for a lleen e to construct or op- this part. sti communicationn and re- c f or basic cosnponent supplied to such fa. erste such facInty: if such in tallatit n, ports concertung the regulations in this cility or activity to comply with the um or operation couh! create a substan- partOf!!ce shouldofbe addressed h Atomic Energy Act of 1954 as amended, tlaisafety hazard; or Inspection andtoEnforcement, the Director, FEDetAt RE0l$Tft, YOL a0, NO. 41-#0NoAY, M A900 2,1973
l ngl PREPOSE3 RULES ' Ua Nucl:ar Regulatory rhun=latan. (5) The date and means by which the l Washington, D.C. 20566, or to the Direc- information cf such defect cr failure to required regulations to assure compliance with the in this part. tor of the appropriate Inspection and comply was obtained-Enforcement Regional Of5ce at the ad-(6) In the case of a basic component broacuant T dress specifled in Appendix D of Part 20 which contains a defect or fails to com- 3 21.61 Failurc io notif3 . C! this chapter. Communict tions and re- ply, the number and location of all such _c ports may be delivered in person at the components in use at, supplied to or Any individual subject to the regula-
/ Commission's omces at 1117 H Street being supplied to a facility or activity tions in this part who knowingly and NW., Washington, D C.; at 7920 Norfolk subject to the regulations in this part conoclously falls to provide the notice Avenue. Bethesda, Md.; or at the appro- (7) The corrective action which has required by 121.21 shall be subject to a priate Inspection and Enforcement Re- been. is being. or will be taken, by whom civil penalty in en amount not to exceed gional Omce at the location specified in and how long it has taken or will take to $5000 for each failure to provide such Appendix D of Part 20 of this chapter. complete, notice, and a total amount not to ex-21*6 Pet"*" *f lasio" 186 What advice about the basic com- ceed $25.000 for all failures to provide a ce Ecurring wh any period Each firm constructing, owning, oper* ponent hss been,is being, or will be given .
ating or supptying basic components of to purchasers or suppliers. of thirty consecutive days. Each day of ! (dl Individuals subject to this part failure to provide the notice required r.ny facility or used in any activity 11-censed or otherwise regulated pursuant to may be required by the Commisalon to by l 21.21 shall constitutc a separate fall-Part.s 30,40,50,10 or 11 of this chapter supply additional information. ure for the purpose of computing the shall assure that u current copy of the applicable civil l'enalty. No individual PaoccarnerMr Doevuxurs found liable for ch-11 penalty pursuant regulations in this part is posted in a con- $ 21.31 Procurement documents. to this section shall be reimbursed, di-Epicuous position on the premises of the
- Each firm constructing, owning, cp- rectly or indirectly,12y the firm of which Nortricarton crating or supplying basic components he is a director or responsible of: leer.
l 21.21 NeqGretion of failere to com- licensed of any facility or used in any activity (See.161. Pub L. 83-703, 68 Stat. 948 see. Pl y or emeente of a defect. or otherwise regulated pursuant 234. Pub. L. 91-101,83 Stat. 444; occ. 206. Pub. to Parts 30,40,50,70 or 71 of this chap- L. 93-438. se stat.124e t42 Um c. 2aos, ass 2 (a) Each individual subject to the reg- ter shall assure that: 6846)) ulations in this part, upon obtaining in- (a) Any procurement documenta is- ' formation reasonably indicating that a sued on or af ter ia date six months after PART 2-flVLES OF PRACTICE facility or activity or basic component the efective date of this partl. specify supplied to such facility or activity that section 206 of the Energy Reorga- 2. Paragraph (b) of I 2.200 is amended (1) falls to comply with the Atomic nization Act of 1974 sprifes to the pro- to read as follows"- Energy Act of 1954 as amended, or any curement if such procurement covers 6 2.200 Scope of subpart, cppilcable rule. regulation, order or 11- basic components and (b) any procure. * . . . . . ctnse of the Commission relating to a ment document issued before [siz months substantial safety harard, or after the eBective date of this parfl. (b) 'Ihis subpart also prescribes the (2) contains a defect shall immedi, covering such procurement of basic procedures in cases initiated by the staff ately notify the Commission, unless such components be modified within 12 to impose civil penalties pursuant to sec-individual has actus! knowledge that the months after ithe efective date of this tion 234 of the Act and section 206 of the .* Commission has been adequately in- partl to specify that section 206 of the Energy Reorganization Act of 1974. i formed of such defect or failure to com- Energy Reorganization Act of 1974 ap-j plies to any remaining action under PART 31---GENERAL LICENSEES FOR
) Initial notification of the Commis- such document. BYPRODUCT MATERIAL sfon of any defect or failure to comply INSPECTION, Rzcoans $$ 31.5,31.7,31.10, and 31.11 [ A mend.
as required by paragraph (a) of this sec-tion shall be made to the appropriate In- 6 21.41 Inspections. rpection and Enforcement Regional Of- Each firm constructing, owning, op- 3. In 10 CFR Part 31, II 31.5(c)(10), lice in such manner as to assure that it is erating or supplying basic components 31.7( b ), 31.11(f) and 31.10(b)(3) are received within 21 hours after the in- of any fact!!ty or used in any activity amended by a hanMna the words " Parts irrmation of such defect or failure to licensed or otherwise regulated pursu- 19 and 20" to readVarta 19,20 and 21", comply is obtained by the individual sub- ant to Parts 30, 40, 50, 70 or 71 of this ject to the regulations in this part. If chapter shall permit inspection, by duly PART 35-HUMAN USE OF initial notification is by means other than huthorized representatives of the Com- BYPRODUCT MATERIAL written communloation, the information mission, of its records, premises, activ-shall be reported in writing to the appro- ities, and of basic components as defined $ 33.31 I AmenJed) priate Inspection and Enforcement Re- in i 21.3(a) as may be necessary to ef- 5. In 10 CFR Part 35, f 35.31(e) is gi;nal Office within 10 days after the in- fectuate the purposes of section 206 of amended by changin; the words ** Parts formation of the defect of failure to com- the Energy Reorganization Act of 1974. 19 and 20" to read " Parts 19,20, and 21. ply is obtained. (c) The written report required by par. $ 21.51 Mainicnance of records. . agraph (b) of this section shall include. Each firm constructing, owning, op- PART 40 .UCENSING OF SOURCE but not be limited to, the following infor- erating or supplying basic components MATERIAL mation, to the extent known: f any facility or used in any activity $ 40.22 I Amended] (1) Name and address of the individual Parts * " *' informing the Commission. ch all,
'
- 0' 7 or 7 o amended by changing the words Parts .
(2e Identification of the facility or ac- a lic'ensee, maintain such ree- "
- tivity or basic ccmponent supplied to such ords in connection with the licensed (Sec.161, Pub L. a3 703. Sa Stat. 94s: Sec.
factitty or activity which fails to comply activity as may be required to assure We: M L ems, sa stat M W nc etr contains a defect. compliance with the regulations in this **N* (3) Identification of the firm supply- part. Dated at Washington, D.C., thle 24th ing the basic component which falls to
~
(b) If a ecnatructor or supplier, main- day of February.1975. comply or contains a defect. tain such records in connecuon with the (4) Nature of the defect or failure to design. manufacture, fabricauon, place- For the Nuclear Regulatory Commin-sion. ' comply and the safety hasard which is $on, ins tio o s ng of a b Jome C. Hons, cnited or could be created by such defect component of any licensed facility or Acting Secretary o; the Commission. cr failure to comply. uwd in any licensed activity as may be
- i (FR Doc 75-5206 PWd 2-28-76,8
- 48 am)
Ptof tAL RE0l$rER, VOL 40, NO. 42--MONDAY, STARCH 3,19r$ e _ -
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20u0 PROPOSO RULES foregoing proposed r hvisions of the Fed-eral Trade Commiss on's rules of prac- SECURITIES AlID EXCHANGE , s tice and procedure which were pub. COMM SSION 11shed in 40 FR 15 t37-15239 (April 4 1975) has been extei ded for a period of [17 CFRI' art 271] 15 days unti! May 20 1975. gge 3 ,3,,,, 3 ,, ,737, By direction of t!b' Commission dated VALUATION OF SHORT TERM DEBT IN-May 5,1975. STRUMENTS OWNED BY REGISTERED larAtl Cri(RLzs A. TosIN, INVESTMENT COldPANIES INCLUDING MONEY MARKET 11NDS
, Secretary.
Notice of Propos< d Interpretation [FR Doc.75-12322 Fil d 6-7-75:9:18 am] Corre ? tion ' In FR Doc. 75-109f2, appearing at page [16 CFR Pasts 3 and 4 ] RULES GOVERNING DISCOVERY AND 18467 in the issue o' Monday, April 28, COMPULSORY PROgESS IN ADJUDICA- 1975, in footnote 1, line 17, the figure TIVE PROCEEDING ) reading 82,434" sho21d read "$2.434" Proposed Rule Cha: iges: Extension of Time to filecomments SMALL BUSINESS 4DMINISTRATION Notice is hereby alven that the time in which to file writti n comments on the [13 CFR Iart 121] foregoing proposed rl visions of the Fed- SMAli. BUSINESS SIZE STANDARDS eral Trade Commiss on's rules of prac- Proposed Definition af Small Petroleum tice and procedures which were pub- Refiner: Extension o' Comments Period lished in 40 FR 15: 39-15245 (April 4 On March 17,1975, there was published 19751 has been exrerded for a period of 30 days until June 4, l975. in the FzDERAL RECIS 'TR (40 FR 12125) a By direction of the Commission dated notice that the Smal Business Adminis-May 5,1975. tration proposed to increase the small business size stanr1mr is for petroleum re-IsEALI CHAsLES A. TosIN, Secretary, finers for the purI>se of Government procurements and silerof Government [FR Doc.75-12323 Fil' d 5-7-75;9:18 am] property. Interested]arties were given 30 days to comment on such proposal. In-NUCLEAR REGULATORY terest in the proposa, he been substan-COMMISSION tial. A number of ca erns have asked [ 10 CFRParts 2h31,35, ano 40 ) that they be allowed t review the com-REPORTS TO THE COMhilSSION CON- ments received and t< make comments in CERNING DEFECTS AND NONCOMPLI. ANCE addition to those already, submitted. ~ Beveral concerns hat > requested that the Proposed Requirements: Extension of BBA hold public hearings .before taking Comment Period' action on the proposi1. ,
~l This notice extends the period for
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s Uder all of the circumstances, we ' comments - to the notice pubL'shed have decided to extei,d'the date for sub. ! March 3,1975 (40 FR 8832), proposing ' mitting comments urtil June 1,1975. All amendments to 10 CFR, Chapter I. Parts / s 2 31, 35, and 40 of the Cammki^n's correspondence and cther relevant mate-f regulations and the addition of a new rial concerning the psoposal are available 4 L -
.- Part 21 to its regulations which would be - for review in the amall Business Ad- '
d ' ' _ entitled Reporting of Defects and Non.' - mtntatration Refererce Library (Room ]j
;t compuwe." 218), 1441 L Street, s several requests for an extension of N.W., Washington, J
, , 'i' time have been received. After considers- D.C. After we have had.an opportunity to
, Lion of the vazious factors involved, the
. evaluate all comments. a decision will be requests for extension of time are made as to whethei a public hearing
-
- granted and. pursuant to' 10 CFR 2.808, should be held. -
"*""'="L*""
,J m. (Catalog of Federal Dosustic Assistance Fro -
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- N gram No. '60Ao2. Boon mac Injury Disaster Loans; 50000 Procurgment Aaststance to "{
-Dated at Wachinaton, D.C. this 2nd ~'t, t._
day of May 1975. hm Businesses, and 50412, sman Bust ' ness Imans) -
~...>e', For the Nuclear Regulatory Ownmin-2, '~
sion. Dated: May 1,1975 p; # :'
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*L BuruxL J. Csm1, TscbrAs S. ELEPPE, Enretary of the Commission. Administrator.
, , . [FR Doc.75-19000 Filed 5-4-7e;10:16 aml {FR Doe.75-13002 Fis d 6-7-78;8:45 em] -
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" - FWERAt 300:5735, V0t. 44, NO. 90--THUtsDAY, MAY 8,1975 a
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I . ,- . RULES AND REGULATIONS 266 9
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4 PART 35--HUMAN USES OF SYPft000CT MATERIAL Group Licensing for Certain Medical Uses Notice is hereby given of the amend-ment of the Nuclear Regulatory Com-mtantan's regulation"Stunna Uses of By. 'T
/
product Material" 10 CFR Part 35. fMRAL RIS15ffe, VOL 44, NO. ISS-WBNESDAY, JUNE SS,1975
e ' .* . 26000 aULES AND REIULATIONS Section 35.100 of 10 CFR Part 35 lists groups of medical uses of radioisotopes that have el= time requirements for user training and experience, facilities and equipment, and radiation safety proce-dures. The notles of proposed rulemaking that was published in the Prosaar. Reon-tra on January 21,1974 (39 FR 2344) stated that the groups of licensed uses would be amended from time to time to add new radiopharmaceuticals, sources, devices, and uses as they are developed. The use of lodine 125 as seeds for inter-stitial treatment of cancer has become a well-established clinical procedure and is hereby added to Group VI. An editorial correction is also made in 3 35.100(d)(1) to correct the spelling of " hyperthyroid-tom." Because these amendments relate solely to procedural matters, the Com-minainn has found that good cause exists for omitting notice of proposed rulemak-ing and public procedure thereon, as unnecessary. Since the amendments re-lieve licensees from restrictions under regulations currently in effect, they may become effective without the customary 30-day notice. Pursuant to the Atomic Energy Act of 1954. as amended, the Energy Reorgani-sation Act of 1974, and sections 552 and 553 of Title 5 of the United States Code, the following amendments to Title 10, Chapter I. Code of Federal Regulations. Part 35 are pubitshed as a document sub-ject to codification.
- 1. In i 35.100, paragraph (d)(1) is amended by correcting the word " hyper-thyrtodism" to read " hyperthyroidism".
- 2. In 5 35.100 Paragraph (f)(7) is amended by changing the period at the end of the paragraph to a semicolon and a new paragraph (f)(8) la added to read as follows:
5 35.100 sched le A Croupe of medieel uses of byproduct material. (f) Group VI. Use of sources and de-vices containing byproduct material for
- certain medicaluses
(8) Iodine-125 as seeds for interstitial treatment of cancer. Efective date. These amendments be-
- come effective on June 25.1975.
(See.141. Pub. L. es-703, se Stat. 948 (42 UA.C. 3301)) 1
' Dated at Bethesda, Md., this 30th day of May,1975. .
For the Nuclear Regulatory Commis-ston. Las V. Oossicx. K2ecadive Directorfor Operations. (FR Doc.75-16487 Filed 6-34.-75:e:45 nel l 790ftAt RBS4$fet, VOL 44, MO.123-W90N990M, MNE 25,1979
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- RULES AND REGULATIONS for materials speclfled in these subsec- centsiners not over 5 gallons capacity Issued in Washing on, D.C. on Febm-tions when shipj ed in containers of each, and packed in strong outside con- ary 11,1916.
5-gallon capacity or less. 'Ibe Bureau tetners are exempt from specification agrees that revoct tien of those subsec- packaging, marking >ther than name of has ' '.Cuans .fr tions should be op 'n to public comment. contents, and labello g requirements. Director, Therefore, the rev >caticns will not take (b) Such shipmer'.s may be accepted Waterials Traraswrfatom Bureau. effect as announce 1 If the Bureau con- on board al; vessels subject to the reg- [FR Doc.76-1966 F1kl 2-2046.8:45 am! siders a future am :ndment of those sub- ulations in this par :. provided the bill i sections, the public will be invited to par- of lading or other ihipping paper cor- Title 1gEnergy ticipate in that rul ' making. rectly describes the In addition, the authority 'for the is- with the true nameassrticle in accordance shown in the com-CHAPTER 1-NUCLEAR REGULATORY suance of the ameJ idments under Docket modity list. Stowag e shall be "O COMMISSION 11M-133 was incor ectly cited to include under cover" or * ' ween decks,n in deck a PART 35-HUMAN USES OF 46 U.S C. 391(a) 1his document corrects compartment not i ubject to artificial BYPRODUCT MATERfAL the authority ettit:on to exclude the heat. reference to 46 US C.391(a), Group Licensing for Certain McEcal Uses In consideration of the foregoing, the 9 446.21-77 Umisc f quantity slupment. 4 Notice is hereby given of the amend-of cennents. ment of the Nuclear Reirdatory Commis-amendments to Pi rt 146 of 46 CFR is. sued on December 31,1975 under Docket (a) Cements, exce pt cements contain- ston's regulation "Iluman Uses of By- . HM-133 (40 FR 6(030) to become effec- ing carbon bisulfide , in glass, earthen, product Material." 10 CFR Part 35. l tive on March 31, 1976, are changed as ware, or leakproof cc ntainers with fiber- Eection 35100 of 10 CFR Part 35 lists fonows: board bodies and me:al tops and bottoms smurs of medical uses of radioisotopes l g146,01-5 [Am< mded) of not over 1 quar, capacity each, or that have similar requirements for user metal containers of not over 5 gallons training and exrerfence, facilities and
- 1. In Amendmelt 5 (I 146.04-5), the capacity each, pack. 'd in strang outside pment, and radiation safety proce-sem! colon follow 1 rig "Turpen tine" is containers are exem; >t from specification changed to a period and the remainder packaging, marking other man name of f g gg g of the amendmen , including the table, contents and labelirg requirements. that was putHshed in the Frnrtet. Hrcrs-is deleted. (b) Buch shi;:me!.ts may be accepted rra on January 21,1974 (39 PR 2384)
- 2. The revocatic'i of 1114F.21-70.146.- on board au vessels subject to the regu- stated that the grours of licensed uses 21-75, 146.21-77, and 146.31-79 an- lations in this part, provided the bin of would be amended from time to time to nounced in Amenilment 9 will not take Tenr or other ship ;ing paper correctly add new radiorharmaceuticals, sources, effect as announced. Those sections will describes the artick in accordance with devices, and uses as they are developed.
remain in full force and effect, and read the true name as ihown in the com- The Food and Drug Administration as fo' lows . modity 11st. Stowag< shall be On deck (PDA) has approved a "New Drug Ap-
$ it6 1 , , under cover' or "Tw*en decks" in a com- plication" for tin Il3/ indium 113m gen-ed quantity shipmenh partment not subjee , to artificial heat. erator for the elution of indium 113m as
~
g 116.21-79 Umite I quantity eldpment. includingchloride for use in klood pool imaging ia) Paint, enam tl. lacquer, stain, shel- placenta lonHmtion and these of inb. lac, varnish, aluininum, bronze, gold, procedures are hereh added to Group wood f!!!er, liquid, and lacquer base liquid (a) Inks, when Jacked in glass or III and thinning recucing and removing earthenware contailers of not over 1 Because these amendments relate compounds theref3r, and driers.11guld quart capacity each or metal containers solely to procedural matters, the Com-therefor, when pa ked in inside glass o- not over 5 gallot.s espeefty each, and miselon has found that good cause exists earthenware conti!iners of not over 1- packed in strong etWe containers are for omitting notice of proposed rule mak-quart capacity eseL or metal containers mnpt fmn spwfication nahing ing, and public procedure thereon, as un-not over 5 gaDors capacity each, and marking other thu name of contents,' necessary. Since the amendments relieve packed in strong < >utside containers are and labeMng requir -ments. licensees from restrictions under regu-exempt from spicifleation packagtng, (b) Buch shipmeiits may be accepted lations currently in effect, they may be-marking other thin name of contents, on board all vessels s ubject to the reguia- come effectlie without the customary 30-and labeling requ'rements. When fiber- tions in this part, rovided the bill of day notice. Pursuant to the Atomic Energy Act of board water gross boxweigh is used 'ornot t must such shipments exceed 65 by lading or other ship ping paper correctly 1954, as amended, the Energ pounds. describes the artick in accordance with ration Act of 1974, as amended, and (b) Buch shipnients may be accepted the true name as shown in the com. Sections 552 and 553 c,f Title 5 of the on board all vessela subject to the reg- modity list. Stowat t shall be "On deck United States Code, the foDowing amend-ulations in this p Lrt, provided the bill 'under cover or % e decks *in a com- ments to T!tle 10, Chapter I, Code of of lading or othe: shipping paper cor- partment not suttjec t, to artificial heat- Pederal Regulations Part 35 are pub-rectly describes th t article in accordKnee lished as a document subject to codifi-cation, with the true name as shown in the im su2, So FR 128. h 9, MI 1. In $ 35.100, Paragraph fe)(4) is commodity list. E torage shan be "On deck under cover
- or " Tween decks" in Int-133 3. 'Ibe authority citation for Docket amended by changing the period at the is correcte<
a compartment n 't subject to artificial (49 U.S.C.170(7), 4 9 to read as follows: end of the paragrarh to a semicolon and bes t. CFR 1.53(f)), a new paragraph (e)(5) h added to read The authority for- making these as N ws-814&21-75 Umlal genetity shipmente changes to the Amer dments issued under 6 33.100 Seliedule A-Groupe of med. of polishes, Docket HM-133 is: i 49 UE.C.170(7) and 3'*I "*** *f I'yproducs matrrial. ta) Polfsbes, a' etal, stove, furniture 49 CFR I.53(f)). * * * *
- and wood, liquid, then packed in inside Effective Date: T tese changes to the '## * *
- glass or earthens Lre containers of not amendments issued under Docket HM-over 1 quart cas scity each, Or metal 133 are effective oni Pebruary 23, 1976. f f u 3 ride for:
y pensat asema, vot, c, no, usowoar, meum n, im 5 -
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a.-.- - .- - - - -
- 3 a RULES AND REGULATIONS mg l
(D Blood pool imaging including pla-e8 cts localisation. K#ective Date:'Ihese amendments be-come effective on February 23, 1976. (Sec.161, Pub. L. 83-7o1, 68 Stat. 948 (42 l UA.C. 220111 Sec. 201 Part 31.14w 93-438,
- 38 Stat.1242 (935, 42 UE.C. 5841))
Dated at Bethesda, Maryland this 22nd day of January 1976. For the Nuclear Regulatory Commis-sion Lrs V. Goeszcz,
. Ezecutive Director for Operations. *
[FR Doc.76-8200 Filed 2-20-76,8:45 am] e x 4 f I 4 9 e e h k
- - - ; m .. .. - y. .y u. ,,r.
d
. o . .. -
EULES AND REGULATIONS MIM (to n c E6*e-2) Title 10-Er.e rry ( 20.102 Urpi.rts of 1.cfs or !w of li-g 1&7.31 '4pp6 M .n% CH AM LR l-NUCt I AR CEGtJt.ATORY " "" d " " ' I
- I *
, An indh! duds a sphratien for a fel-COWISQON * * * - ** * / los ph!; tr.d(7 tl.D ut part shan be sub. N(!knt ous Charges to Chapter ab) Fach lia r.ete sho is requne.d to initted to t'.e Co:nn mio:.e r and shall te g p. .
g in such form u t!. Notice is hereby giun of the arnend- sa) of thb action shau. within tturty Com:ni stoner may ment of the Nuclear Eq.:latory Cer~ #30) days tsf ter he learns of the loss os require. No suth rc Scrition mas be sub- mu.s t;n's re, ulatans in 10 CPR Part mitted to the Com:l i ssioner unless it in- 30. 31. 32. 35, 40. 50, 55. 70.13.140,(af.oh thef t, tnr.ke a riport in u s.ppropriate NRC Regicnal 05ce listed cludcs the fo ;or.tn : 150 shi".h n:e of a tr.mor r.ature. m Append:x D with comes to the Direc-f al The apphrar rs name, permar. tnt On Much 3, :975. the Cornmu:on tcr of Im pxtion sind Fnforcement. O S. add:es; staten.ent r.at he is an Indian pub tshed m the h:rrn Rretsm a re- Nuclear Regulatcry Cornmission. Wesh-tas r, that term timber is d< .ned of dep(nde ts; in i 167.2 8, and vbien of Chgter I of 'ntle 10 of the Code ir.ston. D C, 20555. setting forth the fo!- of Federal Reguhtions to r(fs' et or- tou tng information; * *
- tbi Didtnce thdt the app Rant is in ranfr2uonal and p ror t-dural cha ntes 4. In i 20 403, the prefatory lantu.;ge
- - t.tt<
mhslan ndance as a or has t+en f ull-tae accepted student at an for in- ad- efected er made necessary by the Deerry of para;raph tal and the prefatoo Reort amzation Act of 1974. Janruare of ;cragraph ib) are t, mended stitution of hichtr gducaticn shich is. or The an.endment3 wD) be during the priod for shich the resu:atica set forth t< or. in conform- of the Cor .miscion's to read Es follows: apphcant is apply 2g for a feDouship. jty s ath the s ensed organ:rstjon and cur- K 2M03 Nimran,ien- of incsdent . . f conducting a prcgr m of study descrioed ' rent procedurew chsnre the addresses to in i 167.31. except that: (a) immedicte noti 4 cation. Each 11-which nriouc reports and cop;e4 thereof cen<ee shall im nediately notify by tele- - als If an inisidba! hae not 3ct been should be sent by httn=c e s. The amend- phone and teferrarh. mailgram. er fac-2:cepted for admbs! 3n. he may submit an ments also su elty partrular oices to simile, the D. rector of the appropriate apphration s hirh >?lall be considered by whkh reports should be eddreesed rather NRC Reg:onal OSce Ibted in Appandix the Co:nmirioner. preided that the in-than a ;(neral di:ectne to send itports D of any meldent involving byproduct. disidual b acce p;ed bv an inst:tution by a to the Cem . inion. Tne emendments do source. or spMial nuclear material pos-subsequent Comn.iuioner;date and t bc spw6ed ,by the not add any r.ea reportar requijtments sessed by him and which may hcsc
~
and do not (2) The Commti en(r may,in an ap- qui err.ents for such reports- chance the substantne re- caused or threatens to cause: *** propslate ca.se, rea re as a conditicn for Eccause these amendment s rela te tb: Tarenty-four hour notif:ccrion. approsal of an app..er tion esidence that so!tly to minor matters, the Commis- Each beensee shall withm 24 hours no-the inrtitutJon whlch the appbcant is sion hr.r found that rood cause exhts for tify by telephone and telegraph, mail-attending or intettds to attend is m feet orr.:tt!ng notice of proposed ru e rnatmg, gram, or facsimik. the D rector of the an hcr ed.;cauen penod foru uhich hirh and pubhe procedure thereon as un- apprcpr: ate NRC Rerional 05ce Ibt4d is.orinstit.2 viu betion cf h!lthe durmc. necmry, and for matinr the amend- in Appanda D of at:y incident insolving the appheant is a,7 5 plying for a fellou- rnents efective April 19. !!'76, licensed rnaterial possessed by him and ship, conduct:ng a ?rorram of study de- Pursusnt to the Atomic EnertT Act of which m.a.y h.ase caused or threaters to y scribed in i 187.31; l 1954 as amended, the Energy Rmr- g3 y s, .- g. tc) Copies of tre.r. scripts referred to gam 2ation Act of 1974, as r.rnenced. and * * * *
- in 1 iti.32ia)(1) add evide..ce described sections $52 and 553 of title 5 of the 5. In ! 20 405, the prefatory language in i Isi.32:an 42) shd <3*; United S:stes Code. the f o!;orint rtmend- of pararmph (a) is amende<! to read ks
.ed) Such infortnation as the Commis- ments to Title 10, Chapter I Code of Fed- foUou s:
j sJoner anay requirc a order to determine eral Regulations. Paru 20, 30. 31, 3*:. 35. the an ount of a co t of edacation aUow- 40. 50. 55. 70. 73.140. and 150 are pub- ( 20.403 Reports of oscrcy.omrre an<! y anee for a feDossh p i holdct; and 1hhed as a document subject to coddca- enre..h e Icsch and conceniration . te) Such other nform tion and as- tjon. (a) In addition to any notiScation re-sumnres as the Commistioner may quired by ( 20 403, each bcrnsee f. hall reW PROTE lON A I ST D TION aTcN. n v ty
,.jo t,5 c. 887c-2) (30) dr,ys to the appropriate NRC Re-trTt Doc.ic-12190 r ied 4-sc. .c.s 45 mm) t 20.203 I Amendal) gional 05cc listed in Appendix D with
- 3. In ( 20205, pararraph ebe 2) is copics to the Dirktor of Inspectien and arnended by deleting "te:cphone and Enf orc ement. U.S. Nuclear Regulatory
- CHAPTER X---COhMUNITY SERWCES telegraph *' and inserting in beu thereof C,ommusion. hshington, D.C. 2055g ADMINIS1 RATION " telephone and 141erraph, mailtram. or C*,
facsimile", and Darnfrhph ac)t2) is * ) .
]CSA Inriru don f .W- H) * * * *
~
arnended by deletmg "the beenw shall i 20.107 ( Ammded) PART 1050 -CENLR AL CH AR ACTERtS- immedstely notify. by telephone and TICS OF CouvDNiTY ACTION FRO- telegraph. the final dehs ering carrier and 6. In f 20 407, pararraph (b) b GRAVS the appropriate Nue: car Erfutatory nmended by dc!,eting "Execut2Ve IArector I Subpart--CSA Inco.1.e Poverty Guide!;nes Comrnterion In<pect:on and Enfcreement. t. er
- Cort 'cfion R#E' "*I #h'*" "^ re tor L, t on a d n-and inserting in heu thereof .PT* the licensee fcrtement".
-In FR Doc *l6-M 0 appearing at page shall immediately notify by telephone ( 20.408 [ Amended) 14310. In the I'ntr d Rivasits of Mon- and telerreph, mail rr.m. f or fr.etimile. ~
day. Apri! 5,1976. make the fo!!oning the director of the approprir.te NRC Re- 1 SMtJon 20 408 !s amended by deleting cla rg es: gional 05cc listed in Append 2x D, and .* Executive Director for Operations" and
- 1. Change the CUA Instruction num- the final dcDrering esr:1er. inserting in lieu thereof "DirMtor of In-spection and Enforcement".
ber in the heading 'to read as set forth 2. In I 20.402, pararraph (a) h r.bos e, amended by deleting " telephone and teje-
- 2. On page 14371 in i1060.S2(d)(2), graph and inserting in lleu thercog PART.3D-RULES OF CENERAL AFPLICA-in the table "For au States escept Alaska telephony and telegraph, mailtram, or BILITY TO LICENSING OF EvPRODUCT and !!awai!*". chante the Iret number in facsimile . MATERIAL. )
- 3. In i 20 402, the prefatory la"Fuage 8. In i 30.55. the first and second sen-
' the first -to!umn hei,ded 'Tnmily size" to of pr.ragraph (b) is r. mended to Iend as tentes of psragraph (c) are amended to '
- 8. foUows:
. read as foUon: .,
. .r .
e FlottAt ascente. vot q, No, re--SonDn, Aetit 19, 1976, -
is - _ _ . _ . . _ . I 1 E!!6 RULES AND REGULATIONS 13053 Tritium reporta. -
," . . . e e appicpriate in Ap;d.du D NRC o! PartRe&ntl 09ee 2 3 0! this luid reb met. Co:W cf .c:ch report shall be chipter."
(c) Pacept as sp-cified in piracrnph t efore the w ords "s hleh *'lall state'. u nt to the D.rcc!ct of In3pect.on and id) of this section. cach h enta w ho is rnicrc c ment. U S. Nue: car Regu!r. tory authonted to pmc.s. t~ port, or crport
. Commasion. Washmgton. D C. 20 M 5.
T tntium shall re;ct pro pt!v to the ap- iUMAN USES OF * * * *
- propriate NRC Re;ional 01ce listed in yo . CT MATERIAL 20. In I 5') 54'p), the last sentence is Appendix D of Par t 20 of this chapter 3 33.11 [Anrmcd) amended to read as follows:
by te:cphone and te:c;raph, m st! rarn. nditw, n. of Ikon cs.
- 16. Section 25.14 f b)(5)(1i11 is arnended C or famentie any incident in which an by chang.cg the remicslon at the end attempt h.u been made or is behered to hat e bcon mde to cctm.t a theft or un- thereof te a renod and addmg " Cop.es of 'p) * * * 'Ile !!censee shall rna!ntain lau ful C.t eni:,n of cre th .n 10 curies su:h repnt shall be nnt to the D. rector recNds of chanres to the vbn inade of such mater.al et any cne t:me or Incre of In:pection and Enforcement. U.S. Nu- u ithaut prior Comm!nion approval. and than 100 curies of such mate- al in any c>ar Repfatory Comm:snon, Wash ng- shW furnish to the D:rcitor of Nuclear one cakndar 3 ear. The init:21 report ton. D C. 20055.- Reactor Regulation. U S Nur! car Regu-shall be fol:cu ed u!:hin a penod of fIteen 17. In 13514'e)(3), the ser:nd sen- 12t ry Commi; sion. Washir; ten. D C.
(15) dns by a writ:en repxt submuted tence is amended by insert:rg "with a 2E55. s;th a copy to the appropriate to the appropriate .NRC RNbnal 02:e ecpy to the D; rector of Imp::t.on and NRC Rerional OIc e r;me:f.ed in A; pen-shich sets forth the detaib of the ine!- Erforcement. U.S. Nucicar Repfatory dm D of Part 20 of this chapter a report dent and its consequences Co;ies of such Comm:ss;on. Washington. D C. 20555 - containing a descr.ption of each chan;;e written report shaU be sent to the Di. befere the vords " describing the egup- 3: thin two (21 months after the change rector of Inspection and Erforcement' mt nt". is rnade. U S. Nu: lear Reid.atory Commu.sion. Wa =hington, D C. 20555. * * * ' PART 40--LICENS'NG OF SOURCE $ ,1. 50.33 [ Amended) MATERIAL - STtion 50.55 ta) is amended by
- 18. In ! 40 64(c). the first and second second chandnisentencethe word to "Commhsion" "appro;riate inNRCthe PART 31-CENERAL LICENSES FOR ".nces an amended to read as fol- nc;1onal O" ce shown in Appenda D cf DTPRODUCT MATERIAL las.
Part 20 of th;s chapter with a copy to E 31.11 [ A mended] $ 40.6 8 Ileport s, the D; rector of Inspection and Enforce-
- 9. In i 3111. par.vraph (b) is amended * * * *
- ment. U.S. Nue: ear Repulatory Comm:s-by deleting "O%ce" and rubstituting in (c) Except as spe:if.ed in paragraph slon. Wacharton D C. 20555" lieu thereof "D; rector". 22. Sicucn 50 55(ca (2) is amended bv (d) of this sect.on. each licensee aho is authorized to poness tranium or tho- chr.;mg the w ord "promptly" to "uithiin FART 32-SPEC'FIC LICENSES TO U AN- riu n pursuant to a specJic Lcense shall 24 hou s1 UF ACTURE, D:STRIBUTE. CR WPORT repcrt prcmptly to the appre; riate NRC a3 In f 50 55(ei t3) the first sent
~
CFRTAIN IT E"S. CON T A :'U NG DY. IDenal O2e IM in Appentz D of 13 nEended to read as fonon s- ' PRODUCT t/ATERIAL Part 20 cf this chapter bv tdephcne and $ 50.33 Condition. of con.trursion pcr. tt'cgraph rnai' gram or l'atsum:e any in- an h s. ( 32.12 [ A mcoded] cident in s.hich an attempt ha.s been * *
- 10. SectJan 3212 is arr.endad by iruert- c c=m:pr mm ed a has e bem M to nate NRC tais t or @ u M G emon of (e) ***
Ing "n!!hO"ce a cory to inthe (36 The ho! der of a cenetruction pcr-RGlons) listad Apap; r[endix Dmue of 15 Wds o s Part 20 of this charter." b(fore the words av cne m er men u,f such n 1MmatzpoMr alofat mit shs11 a'.so enbmit a ur:iten report en y *Thich sha!! ! dent;fy"* a reponaEe dencimry Cin thiny (30) su:hinitial The rnatenal reportin sha!! any one calendar be fcilou year. dns to the appropnate NRC Re:ntnal ed wi'h-I 32.16 i buended] in a period of fif teen il5' days by a u rit- OZee shown m Ap;nad:.x D of Part 20 II. Section 32 IC is amended by insert- ten repo-t submitted to the approprute of this chapter. Copics ci such re;nrt Ing "rlth a copy U) the apprornate NRC NM Nenal OSee shich sets forth the shin be sent to the D: rector of Inepx:f 2n Re;;ienal 05ce hJted to A;;wndix D of de alls of the incidet and its conse- and Erforcement. U.S Nuclear Re; ult. Part 20 of this chaner," before the words Caences. A copy of such a r!!!en report 20555. tory Co nm.ssion. Washmg ton. D.C.
"s hich sh2H include". shan be sent to the D: recto. cf Inspec- ***
tion and Enforcement. U S Nuclent Rag- a4. In 6 50 59(b), the fourth sentence 5 32.:!0 ( Amended) u!atory Commission, washincten. D.C. is changed to read as fc ;ows: ' 12. In i 32 20. the second sentence is 20555 * * * $ 50.59 G anges, te.ti, a nd n periments. amended by chanr.ng the period at the * * * *
- l end thereof to a comma a.nd inse/*mg PART 50-LICENSING OF PRODUCTION "irhh a ecpv to the r.porornate NRC AND UTILIZATION FACILITIES abi * *
- The license
- shan furnish
, Recional 05ce lisic1 in Ap;endtx D of to the appropr: ate NRC Regional OSce Part 20 of this chapter.' 19. In 150 3CataH2), the first untence show n in Append:x D of Part 20 of th:s-is amended to read as follows: chapter s1th a copy to the Director of ($ 32.23 and 32.29 [ Amended] g 30,3r,a Technteel .peciF. cations on ef. Ins;metion and Enforcement. C 3. Nu-
- 13. Sections 32 25(c) and 3".2Mc) are ff urno (en nmirar gun.cr reen1 ors, clear Re7u'atory Commits!cn. W:.shing.
a'r.tnded by insert:ng "with a copy to the (a) **e ton, D C. 20555, sn: uaDr or at such appropriate NRC EcconC Oiee listed shorter intervals as may be specfied in to .ippendix D of P.rt 20 0! L: ts chapter " (2) "Ite rutmiulan of a report to the the license, a report conM:mng a brief bedore the :.ords ' e tich shall melude". appropnate NRC RT.onal O".ce shown decer:ption 'of ruch changes, tests r.nd tn Append:x D c! Part 20 of this chapter evenments. Including a summary of the E 32.32 [ Amcmini] withm nAty 16M days af ter January 1 sMety evaluation of each. * * *
- 14. Sect!an 32 $*'ai is amended by in* and July 1 of each year spk:fying the *'
serting *vith a copy to the napro;rinte quant:ty of esch of the rrineral raio- * ".0'71 1 '% * *"ded ) NRC Rei:1cnal O",cc fitted tn AppendW D nuchdes relea<ed to unt(str!rted arras m 25. Sdtion 50.71(b). Part 50. Appen. cf Part 23 of this chap:er," tefore the bqdd and in cas&cs c"'u(nts d tr:nr the dix G. Section V.E, and Appendix H. words "au trarufers of smh dutccs". prev:ous six 46) mcnths of operation. Sxtho IV.A. are amended by chant ing and such other ($ 32.56, 32.60, and 32.63 [ 4 memies!) required by the Commis ton to est. mate infctmat:on na may be the sord "Ccmmission" to " Director of Nuclcar R eactor Regula tion. U.S. Nuclear
- 15. ftections 32 56. 32 60. and 32 C3 r.re maximum Intent!at annual rad:ation Reruhtory Commission. Wa e.Inended by insertmg "utth a copy to the doses to the public resultag from cl"utat D C. 2 05 5 5.".
ItDttat et Citttt. WOt. 41. NO. 76-MONDAr, Arcit 19, l94
e . l 36148 aULES AND REGULATIONS days by eritten rer ort submitted to the istra tion. P.O. Box E.t )ak Ridge. Tennea- stated that the gmups of 11cen ed uses cppropriate NRC Rc rional OCre shown see 37830. and three i li copies to the re- would be amended from time to time to in Appendix A of Pai t 73 of thS chapter. cener of the material promptly af ter the add new radiopharmaceutical.c. sou.rce< . whichCoples Cent. sets forth the deta!b of the inci- tran*fer takes place.F ach person who re- devices, and uses as they are developed of such j wntten report shall cenes such matenal a ball rutmit a ccm- The Food and D ug Administ auen m be sent to the Directar of Inspecuon and pieted copy of Fonn ? RC-741 to tne U.S. (FDA) has approved a "New Drug Ap-Enforcetnent. U.S. Vuclear Herulatory Energy Research anc Deselopment Ad- plicatzen" for ytterbium 169 as la-C;mmission, WashhTton, D C. 20555.m rrunistration and to :he shipper of the beled diethylenetnarninepentaaeece ac:d
- 40. In i 150.17, tl e second and third matenal within ten los days af ter the (DTPAi for cisternography and this pro-sentences in paragraph (a) are amended rnatenalis received. cedure is hereby added to Oroup II.
to read as foDous end the fourth sen- . . . . .. Because this amendment relates solels tence is deleted, an:! paragraph (c) is (c) Except as spec; Sed in paragraph to procedural matters. the Commission
, cmended to read as i>1 lows: (d) of this section, each person who. has found that good cause exists for
$ 150.17 S ul,mi..iom so Comminion of pesuant to an Agree nent Sate beense, om:ttmg nouce of proposed rulematmg.
sourre rnsterial iran.fer reports. is atethort:ed to poss( F s tritium shall re- and pub!1e pmcedure thereon. as unne:- (a) . , Each persen who transfers port prompuy to thi. appropriate NRC essary. S.nce the amendment relleses h-such material shall ubmit a completed Repenal Oice as sTown in Appendix censees from restn:tions under regula- ' copy of Fo m NRC-[.41 to the U.S. En- D of Part 20 of this cliapter by telephone tions currently in erect, they may be-and telegraph. mat' ram, or facsimDe come efective without the customary 33-Crgy Research and Inclopment Admin
- any incident in thi h an attempt has day notice.
1stration. P O. Box E Oak Radre.Tennes Pursuant to the AtorrJe Energy Act of see 37830. and threr (3 cortes to the mademade been to or is bel eved to hase been comm:t a ti ef t or unlawful dj- 1954. as amended. the Energy Reorgan - reccher of the matenal promptly af ter the tramier takes plue. Each person who senion of more thal 10 cunes of such zation Act of 1974 as amenced, and Sac-t receives such mate 1al shall submit a mr terial at any one time or 100 cunes tions 552 and 553 of Title 5 of the United completed copy of F?rm NRCw41 tc the of such matenal in any one calcndar States Code. the fouowing amendment s ear. The initial repcrt shall be folioned to Title 10 Chapter I. Code of Federal UA Energy Reseanh and Davelopment hithm a penod of f. tee:1 115s days by Regulauons. Part 35 is pubhshed as a Adminhtration and .o the shipper of the a written report subrutted to the appro- document subject to codificauon. antterial within ten (10
- days af ter the pnate NRC Remonal 05ce thsch sets 1. Section 35.100. Paragraph a bi'24 '
inaterial is received. forth the details of 1he incident and its is amended by changing the period at consequences. Ccpie< cf such uTitt(n re- the end of the paragraph to a semicolon (c) Except as sp<cified in paragraph port shall be sent to the Daeetor of In- and a new paragraph (b,825) is acded (d) of this section, each person who is spection and Enforci ment. U.S. Nuclear to read as foUows: cuthorized to pose pursuant to a spec:*le urarJum license or thonum frem Regulatory an D C. Commrr len. Washington. $ 33.100 Schetfule 4 C rou p. of WI. 20555. Subsmue :t to the submission ical tie ofIs produrs r Wirrial. Agreement State sha!! report promptly to of the written repe 't required by this , , the apprepnate N:?.C Regional OSce pa-agraph. cach pe] son subject to the , , , sborrl in Appendix D of Part 20 of this provulens of this paragraph shall (b) Group II. Use of prepared radio-ch:pter by telephi ne and telegra ph. promptly inform th appropnate NRC pharmaceuucab for diagnostic studies Innilgram, or facsin.'ile any incident in Re;nonal O1ce by ineans of a written involvmg imagmg and tumor localiza - A which an attempt i as been made or Ls report of any s.ubstantn e add:tional in- Mons. believed to hate berri made to commit a fo mation, which bicomes ava:lable to * * * *
- theft or unlawful di ersicn of more than such person. concerMng an attempted #25 e Ytterbium 369 as labeled dieth>!-
,,15 pounds of such inatenal at any one *cr apparent thef t o: unlawful d:ven. ion enetnaminepentancetac acid (DTPA 6 for dime er more than 150 pounds of such of tritium, cisternography.
Insterial in any om miendar year. The El'ect:r e date. Th<se amendments be- Effectire date: This amendment be-pe o f e (15) da s a UC" d'# # "D3 O' ""* **
- D written re;mt suba,itted to the appro- tsee.16:. Pub. L 83- 703 es stat 54a 142 tsec. 81. Icl. Pub L a3-vos, ce stat 931 %e priate NRC Region L1 Of".ce which =ets Us c. 22cO: see. 2M.1 -ub. L 03-43a. ss stat. (42 U.s c. 2111. 22c: : sec. 201. Pub. t. 93 forth the details of the incident and its 1242 62 t'.s c. f,84 O L 438. 88 stat.1243 e 4.2 US c. 5641).)
consequences. Cople : of such sTitten re- Dated at Rethesda Maryland this 25th Dated at Bethesda, Maryland this 7th port shall be sent t< the Deectcr of In- day of Maren 1976. day of April,1978. I to y Com ss on, h31 For the Nuclear Legulatory Commis- For the Nuclear Ragulatory Commfu D.C. 205 55. Subsequl 'nt to the rubrnission 'I D- sion. of the *Titten repi rt required by this y, , paragraph, esch person subject to the Executirc Direcfh for Operatio ts. Executire Directo-provisions of the parag aph. shall 1FR Doc.76-11058 ru -d 4-16-76.8:45 aml
- jo, Operatsov~'
promptly inform tl.e appropnate NRC lFR Doc.76-11270 Fded 4-ler76 8-45 anu Regional Of$ce by a cans of a wntten re- ~ port of any substan- :ve additional infor- , PART 35---HUMAN USES OF trction, which becc:les avr,tlable to such BYPRODUCT MATERIAL CHAPTER ll-M DERAL ENERGY penon, concerrung in attempted or ap. Group Licensing for Certain Medical Uses ADMIN 15TRATION parent thef t or ui lawful diversion of PART 211--MANDa TORY PETROLEUst Notice is hereby given of the amend- ALLOCATION REGULATIONS
- source material
- ment of the Nuclear Regulatory Commis-
- 41. In i 150.19. t. :e second and th!rd ston's Rerulation Human Uses of By- PART 212-M ANDi, TORY PETROLEUu sentences of paragr; ph tal are amended product Matenal." 10 CFR Part 35. PRICE REliULATIONS to read as fonows 1nd the fourth sen- Section 35.100 of 10 CFR Part 35115t8 Crude Dil Buy /Se!! Program tence is deleted, a1ld paragraph ac) is groups of medicrd tLies of radioisotopes amended as follows: that have similar regturements for user On February 27 1 ?76, the Federal En-1 150.19 Suhmini.n to Commi ion of training and experience, f acilities and proposed rulemakini: d issued a nouce of and publ.ie henring trhium reports. equipment, and radiation safety proce- (41 FR fl96: Marc!, 3,1976), to amend (a) * *
- Each 1 erson sho transfers dures. Pa-ts 211 and 212. C napter II of Title 10, such material shall submit a completed The notice of pronosed rulemaking Code of Federal ReiulatJons, to conform copy of Ibrm NRC -741 to the U.S. En- that sas pubhshed in the Frr,raA1. Rre. the coverage of the buy / sell program to :
ergy Research and :kvelopment Admin- 1sisa on January 21,1974, l'39 FR 2384) that of FEA's Mandatory Canadian FED! tat REGt$ff t, VOL 41, NO. 76-MONDAY, APtit 19,1976
k ; RULES AND REZULATIONS 34633 7 -- an order until appro ral ts grated by GSA. shad meet them b:' placing an order The notice of proposed rulemaking
' The preorder revie e of user selection ata ht the multiple 16 ward schedule con- that was published in the Frenal Rtc-procedures is intend ed to ensure a com. tract of the selected endor, tf one exista. Isrza on January 21,1974 (39 FR 2384)
,P _ plete evaluation an ! competitive selec- Such a procu2Tment till be ccnssdered to stated that the groups of licensed uses
- tion of teleprocessi: g services, have been made- ur. der the TSP. De would be amended from time to. time to
- 8. P_ostorder reric rs. Within 20 work- processing procedurei for noncompetitive add new 'radiopharmaceuticals. sources, G days after placing an order against a acquisitions shall be 'ollowed. (See para. devices. and uses as they are developed.
.!- multiple award schedule contract, grapha Ec. Y, and 8. - The Food and Drug Administration
., agencies sha!! subm t to the appropriate d. Make a so4e a ource ' procurement (FDA6 has approved a "New Drug Ap-GSA regional ASCI a copy of the order . from a non-rsultipleararrd schedste con. pheation" for todine-125 as fibrinogen and a copy of the economic evaluation tractor. his is the Wast attractive pro- for the detection and monito-ing of de-k or sole source justlNeation upon which curement method ard is to be used only seloping deep vein thrombosis and these
- g the order is based if any of the fo' lowing in the case of an unosual situation. Such procedures are hereby added to Group
- thresholds are exce<ded: procurements shall r ot be considered as II-havirg been made 1Lnder the TSP and Because this amendment relates 1[T . Iw rur anter shall require recropetition within 2 solely to procedural matters. the Com-f g years. The provisionsof paragraph 6 con. mission has found that good cause 1 E7n mci.C cerning procedures for recompetition exists for omitting notice of proposed shall apply, rulemaking, and pubile procedure f A nnuawr . .. . .
sy m u m . s in mn so.ao oomo 10. Efect on ot/ er issuances. 'Itds thereon. as unnecessary. Since the a oto regulation supplemer ta requirements ex. a:nendment reheves licensees from re-pressed in FPMR 1 11-32.2 and cancels strictions under regulations currer.tly in
'Ite postorder rtview is intended to GSA Bullet n FPMR F-72. effect. It may become effective without identify problem arr as and unique agency 11. Comments. Conments may be sub, the customary 30-day notice.
rnethods for selectin I teleprocessing f!rms mitted to the General Services Adminis- Pursuant to the Atomic Energy Act of ( in an attempt to imarove evaluation and tration (CPSB), Wa~hington, DC 20405 1954. as amended, the Enetgy Reorgani-
- g. selection procedure. on or before October l5.1976. zation Act of 1974, as amended, and
- 9. Inferim procet ures.,The 'IEP shall 12. Arcilabihty of OSA Forms 2068 and Sections 552 and 553 of Title 5 of the I become the mandat>ry method by which 2068A. Agency field ofr.ces shall submit United States Code, the folkwin g i
agencies meet the r commercial tele- all requirements for hese forms to their amendment to Title 10. Chapter I Code processing requirerlents when a suf5- will Washington headqu trters of5ce wh!ch of Pederal Regulations. Part 35 is pub-ciently large numb tr of multiple award mentsforward consolidtted annuai require- lished as a document subject to cod!- to the General Services Adminis- f! cation. schedule contracts are awarded. Agen- tration (BRO), Wa.s11ngton, DC 20405. 1. Section 35.100. Paragraph (b) f 255 cies shall attempt t<> defer teleprocessing 13. Assistance. Pur her information on is emended by changing the period at ag y et opriate G re AD ha g x
- s ha de is rio fe sible, the following 1 rocurement methods changes. (See FPMR 101-32.4800 for to d llows
- listed in order of preference shall be addresses.) 5.33.100 Schedule A-Group
- of medi.
g employed:
- a. f]se the basic < greement for a com- JACK EcKERD.
petitire procuremei.t. A procurement of Administrator of General Services. * * * *
- At'cusT 3,1976. (b) Group II. Use of prepared radio-this type will be <onsidertd as having pharmaceuticals for diagnortie studies been made under t! e TSP, and the later {FR Doc.7643773 Pth4 5-13-76.8:45 am] involving imaging and tumor locahza-transition in accorcance with paragraph tions.
6 of this regulation diall not be required. j Por these reasons til Title 10-Energy . . . . . s method of procure ment is the most i, dvantageous for the' y CHAPTER 5-NUCLEAR REGULATORY (26)' Iodine-125 as fibrinogen for de-Government agenei Ps requiring teleproc- COMMISSION tection and monitoring of developing essing services at tils time. PART 35-HUMAN USES-OF BYPRODUCT deep vein thrombosis *
- b. Conduct a corr petitfre procurement MATERIAL GROUP LICENSING FOR CER. Effective date: This amendment be-trithout incorporat 4g the basic carce. TAIN MEDICAL USES con 2es effective on August 16, 1976.
ment. Agencies ma y elect to conduct a Notice is hereby given of the amend- (Sec. 81,161, Pub. IAw 83-7o3. 68 Stat. 935. competitive procu rement of services ment of the Nuclear Regulatory Com- 948 (42 Ua c. 2111, 2201): See. 2c1, Pub. without using the BA. However, such mission's Regulation " Human Uses of Law 93-438. 88 Stat.1243 (42 Ua C. 5841) .) procurements will l'e considered as hav. D7 product Material," 10 CPR Part 35. Dated at Bethesda, Md., this 4th day ing been made out;ide the TSP, and re. Section 35.100 of 10 CFR Part 35 lists of August 1976, competition in ac,:ordance with para. groups of medical uses of radioisotopes For the Nuclear Regulatory Commis-graph 6 will be ret utred. that have similar requirements for user alon.
- c. Place a sole source order against a training and experience, facilities and Las v. OossicK.
multiple atrard schdule contract. Agen- equipment, and radiation safety pro- Executire Director for Operations. cies with valid sol ( source requh-ments cedures. fra Doc.76-23970 rued s-13-7e.8:43 aml MDERAL 8EGl5rtt, VOL 41, NO.159-JAONDAY, AUGutT le,1976 , i
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[' - 7 3 c. y . . 7] j rulesandregulations (j This section of the FEDERAL REGISTER conta6ne regulatory documents having general appl 6cability and legal effect most of which are I keyed to and codified in the Code of Fe4eral Regulations, which is pu bHahed under 50 tittee pursuant to 44 U.S.C.1510. l The Code of Federal Regulations is sold by the Supenntendent of Documents. Pnces of new books are listed in the first FEDERAL _ [ REGISTER lasue of each month. l 3
-Title 7- Lgriculture and published infornation including a 1, Section 35.100 of 10 CFR Part 35 is CHAPTER XVil-R JRAL ELECTRIFICA- comparison of the praposed specification amended by revising I 35.100(c)(3)(1) to :
TION ADMINISTR LTION, DEPARTMENT requirements with Fxleral Specification read as follows: :K OF AGRICULTURI: 'I'r-W-00571J, REA .las decided that the e e e e e ~B PART .1701--PUELIC INFORMATION o a y, dRA et n 6 33. &h n in of medi. REA Bulletins: Pres <trvative Treatment of 2:345-1 is being issu rd as proposed with Wood Poles, Stubt, and Anchor Logs an eHective date of January 1,1977. - (c) Group til. Use of generators and Appendix A to Iart 1701. Title 7, is Dated: December te,1976. reagent kits for the paparation and use hereby amended to provide for the revi-of rsdiopharn:aceuticals containing by-l a
. sion of REA Bulle ,in 44-2:345-1, REA > AVID A. HAMII.'or*
Administrat product material for certain diagnostic Specincation DTW C:PE-9 for Wood uses* Poles, Stubs, and Anchor Logs and for lFR Doc.76-37562 Puid 12-23-76,8:45 arn] Preservative Treatrient of these Mate-rials. Title 10--Energy (3) Reagent kits for prepartion of In accordance wilt 1 proposed rulemak. technetium-99m labeled: Ing procedures, nonce of the proposed CHAPTER M REGULATORY (1) Sulfur colloid for !!ver, spleen, and revision of REA Bu'letin 44-2:345-1 was bone marmw imaging.
- published in the 7 :DzmAL Rectsrsa on PART 35-HUMAN USES OF
- e * * * *_3 March 5,1976 (41.H 9557). Interested persons were given 30 days in which to BYPRODUCT MATERIAL j Effective date: 'Wis amendment be- M submit written data, views or comments. Group Licensing for Certain Me:!ical Uses comes effective on December 27,1976. %m The oniv commer1t received as a result Notice is hereby given of the amend- (seca. si,161b, Pub.1. 83-703, 68 Stat. 935, 5 of the notice of t1ie proposed revisbn ment of the Nuclear Regulatory Com-took exception to the preservative reten- mission's regulation " Human Uses of tsa 42 g 21,1,1 1 b. I. <
g tion requirements !<ir LPG treated poles Byproduct Material,'"10 CPR Part 35. Dated at Bethesda. Maryland this 8th , stated in Table 10 o! the proposed spect- . Section 35.100 of 10 CFR Part 35 lista day of December 1976. ; fication. gmups of medical uses of radioisotopes Fbr the Nuclear Regulatory Crrnmin- ' In the . revision .)f the specification, that have simune requirements for user sion. ? REA has proposed an assav of two zones training and experience, facilities and & (outer and inner), iather than an assay equipment, and radiation safety proce- Lrr V. Oossrex, y E
, of only an inner z< ne for LPO treated odures. .
...c . , . Execuffoe Direi for for Operations. ? "
poles. The cramm ator did not object . The notice of proposed rule making to the two-assay scne requirement, but that was published in the Pznemas. Rao ' [ra MsM9erued 1623-Te:s:48 mmIY 'N i did recommend thi,t REA specify the y Isrst on January 21,1974 (39 FR 2384)
$u s
. . , same retentions for both the LPO treat- stated that the groups of licensed mess n Title 1h-Bana and Bag , __
q ment and the pen <a in heavy. solvent would be amended frorn time to time to . CHAPTER 1-- COM1 ' TROLLER Y 3 TM ' _ p treatment. 'Ihe exception by the-comAa4d new radiophsfmaceuticals, sources. .-SURRENCY DEF UtTMENT WF "" ,e 4 i meatator was baseit essentially en the devices, and uses as they are developed. ' '~ iTREASURY , ( C, -195 - "'^ 73 pmposed retention requirement in "the he amendment of 20 CFR 35.100(c) outer assay sone oero to 0.5 inch for (3)(1) adds the use of sulfur coDoki for .- PART ' 1-INVESI AENT 4tEGUI ATION SECURITIES
$=
Douglas fir and the 1line species, and sero . bone marrow imaging. his change in " M to 0.6 inch for wei tern larth and the Group III confor ms with the Group II.10 Editorist Revision of Undesignated Center ,
.n cedar species for w11ch only the outer CFR 35.100(b)(21), use of technetium- - - He mis 4 assay zone wiu be tuquired). 99m as labeled sulfur colloid for, liver, . We existing 'u ndesignated center ; i The proposed sone assays and reten- spleen, and bone marrow imaging, ' heads following if1 12 and 1.226 suggest . d 5 tions are lotended tc imorove the cuality Because this amendment relates solely that a different cat:1 ory of ruling follows -
of IPO treated poles and are considered to procedural matters, the Orrnmtmalon each center head. Eince this is not the ] necessary because >f field experience. hai found that good cause exists for case the exisung ceniter heads are W The proposed retenti3n in the outer assay replaced by a single revised center head
=
4 omitting notice of proposai rule umNng' more sone is based on ane requirements of accurately describing the rulings , 4 Federa18pecificattor. TT-W-00571J. ne and public procedure thereon, as tm* which follow. $ Federal specificattori recuires an assay of necessary. Eince the amendment relleves 12 CFR Part 1 Isl ciended by rescind-only one sone, which in the thin saowood licensees from restricuons under regula. ing the undesignatet. center head follow- Q nii species is a narrow sone near the pole ' Mons durrently in efect, 2 may become 'ing I L226 and by z evising the undesig.
, l surface. This narrow asasy sone near the effective without,the custamary 30-day , nated center head follo1 ring 1.1.12 to i g pole surface is campirable to REA's pin- nouce.. , 'j .
read as Mllows4 r , ,
. ,m ,- g posed outer assay soite, and for the outer -
Pursuant to the Atomic Energy Act of $sCUnITrrs Epcts aT yon Punenaas, m _a mone we have propcoed the same reteni 1964, as 4 mended. the Energy Reorga-( Daam av ano 1 Tmawaimo$m- - . Q tion value as that il the Federal spec- nisation' Act of 1974c as amended.' and " ' ' " " " .' 'a* ~b N *i ification for the naTow sone near the . Sections 552 and 553 of T$e 5 of the' Dated: December 17, 1976. pole surface. United States Code, the foDowing amesut- _,5 f
- 11 ossar.Blcost,
. - After conalderstk n of the exception merit to fntle' 10. Chapter I,' Code 'of> 'a Actin y Comptrollerof ' Y- J and supporting stata inents, and after an Federal Regulations, Part 3S'is publishe'd - '_'
~ extensive review of. nya!!ibl(fleld data as a document subject to codification. , (fPR Doc.76-37793 Fu N113-234058:45 aml m the Currency ,,"-' _
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PROPOSED RULES 12185 section and il 1011.PD and 1011.31. each uniform price for exe ess milk of 3.5 per- Proposa! No.13. R f vise paragraph (a) handler shall report such other informa- cent butterfat cont:nt received from of i 1011.75 by cllanging the word
- tion as the market 1dministrator deems producers;
- price" to the word ' prices" necessary to verify c restablish each han- (3) From the ami'unt resulting from Proposal No. If. R vise paragraph (b)
) dler's obhgation u:- der the order, the computations pu sunnt to paragraph of I 1011.75 by chant mg the words " uni-(a) (lI through (3) :! this sectior, sub- form price' to the wiirds " weighted aver-Proposaf No. 3. R< vise i 1011.61 to read tract an amount con puted by multiply- age price" a-herever they appear in the ggggy,' ing the hundredweis it of milk specified paragraph.
$ 1011.61 Gmputai<m of uniform in paragraph (an d4 > + 11) of this section Proposal No.15. I:evise subparagraph price (imludilig weighial escrase by the weighted average price; ta)(46 of i 1011.7f by changing the prier and uniinrm price, for lea e (4) Subtract the Iotal value of excess words " uniform pi :ce" to the words and ru en milk ) . milk determined by Inultiplying the uni- " weighted average rrice" wherever they (a e For each mtnth the market ad- form price obtained in paragraph (b)(2i appear in the subpa agraph.
ministrator shall ci >mpute the weighted of this section times the hundredweight Paoeosto av Tur Darny Drvisrow. average price and ic r each of the months of excess milk from tlie amount computed AcarcrLTraat M inntTING SERVICE of July through Fioruary, the uniform pursuant to paragr:iph (b > (3 ) of this Proposal No.16. Make such changes price per hundredweight for milk of 3.5 section: >unt calculated pur- as may be necessar:' to make the entire percent butterfat c4 ntent at pool plants
> (5) D1 vide the am at which no locatto 1 adjustment applies suant to paragraph (b)(4) of this sec. marketing agreemer t and the order con-tion by the total hu dredweight of base form with any ame: dments thereto that as follows: lese computations; may result from th 5 hearing.
(1) Combine intr one total the values milk included in t Copies of this nc tice of hearing and computed pursuant to i 1011.60 for all and 46 Subtract not less than 4 cents nor the order may be procured from the handlers who filed the reports prescribed in i 1011.30 for the nonth and who made more than 5 cents from the price com. Market Administra:or J. E. Bobo, allding. 4711 218 Old the paymmts purs : ant to i 1011.71 for puted pursuant to I- nragraph (b)(5) of Kingston-Forest I . Knoxville. Tennes- ' the preceding monta; this section. The re,ulting figures shall Kingston Pike. 8.W i the Hearing Clerk.
- 42) Add one-hall the unobligated bal- be the uniform prict for base milk of 3.5 see 37919 or from nistration Building.
percent butterfat c:ntent f o.b. market. Room 112-A. Adtn cnce in the produce 3 settlement fund; (3) Add an amoiint equal to the total Proposal No. d. Re ,ise i 1011.62 to read United States Deptrtment of Agricul-ture. Washington. ItC. 20250 or may be value of the locatid n adjustments com. as follows: ##' " ## # puted pursuant to l 1011.15; g 1011.62 Annoum , ment or uniform (4' Divide the re ulting amount by the pricca and butic fat differential. Signed at Waa lington, D.C.. on: sum of the followiria for all handlers in- February 28,1977* cluded in these com >utations: The market adm nistrator shall an-Witti s T. M4xtry. (1) The total ht udredweight of pro. nounce publicly on or before: Deput/ Administrator. (a) The 5th day s fter the end of each ducer milk; and Prgram Operchons, (11) The total hundredweight for month the butterf at differential for such which a value is c' imputed pursuant to month: and [FR Doc.77-4447 F :ed 3-2-77.8:45 mm] (b) The 10th day Lf ter the end of each I 1011.60(f n ; and (5) Subtract not ;ess than 4 cents, nor month the applicabli uniform prices pur- g g gggg more than 5 cents per hundredweight. saant to 11011.61 frr such month. Proposal No. 5. R< vise i 1011."1(a)(2i COMMISSION The results shall tx the " weighted aver. age price" and sh t11 be the " uniform til by replacing th
' word " price" with
[ 10 CFR Part 35 ] price" per hundre : weight for milk of the word " prices". Proposal No. 6. R4 vise i 1011.71(a)(2) HUMAN USES OF BYPRODUCT 3.5 percent butterf< t received from pro. MATERIAL ducers in each of the months of July (11) by changing 1 tie words " uniform through February. price" to " weighted tverage price" Specific Licenses to Individual Physicians Proposal No. 7. I ,cvise subparagraph and institutions (b) For each of he months of March through June, the iurket, administrator (al(!8 of f 1011.7: by replacing the Following its organization under the shall compute the uniform prices per words " uniform pri ce" with the words Energy Reorganization Act of l974 (Pub. hundredweight for 3ase milk and for ex. weighted average 1 . rice
- L. 93-4381. the Nuclear Regulatory Com-L5 percent butterfat Proposci No. 8. N rithin the introduc- mission (NRC) has stated its intention cess milk. each of tory text of subpi ragraph (at(28 of og ,.eviewing those of its regulations and content f.o.b. marks t as follows:
(1) Compute the total value of excess i 1011.73 replace t le words uniform procedures pertaining to the licensing milk for all hand ers included in the price , with the wor isreplace " appropriate uni- and regulation of nuclear facilities and the words materials that were originally promul-computations purs .iant to paragraph form price (si . and (a)(1) of this sectt in as follows: of milk with the words "of milk or gated by the Atomic Energy Commission, (16 Multiply the 1 .undredweight quan. base milk and excess milk . with a view to considering what changes tity of such milk w Tich does not exceed Proposal No. 9. ,1 levise subparagraph should be made. the total quantity if producer milk as. (citti of i 10ll. o by changing the Su m mary. The Nuclear Regulatory signed to Class III ri tlk in the pool plants words " uniform p ice" to the words Commission has under conalderation an of such handlers b: the class III price; weighted averate l > rice - amendment to its regulations in 10 CFR (118 Multiply the remaining hundred. Proposci No. Joy Levise subparagraph Part 35. "IIuman Uses of Byproduct Ma-weight quantity oi excess milk which (c'82> of i1011.o by replacing the terial." The amendment would require does not exceed tl ie total quantity of words " uniform pr re" with the words a medical institution to be licensed for producer milk assh ned to Class II milk
- appropriate uniforn pricers)" byrroduct material used in the institu-in the pool plants n! such handlers by Proposal No. II. Fevise subparagraphs t on rather than the individual physi-(di(3i through id (6i of i 1011.73 by clan using the byproduct material. This the Class II price; i111e Multiply the remaining hundred. renumbering such subparagraphs to would be accomplished by limiting the weight quantity of exces milk by the id)a4> through (dI(7 and adding a granting of individual phystelan licenses Class I price; and new subparagraph (ds(3) to read as under i 35.12 to a physician or group of (iv > Add toge ,her the resulting follows physicians in private practice in an
, amounts; 43i For the mont is of March through of5ce outside the institution. (In order 7
(28 Divide the 13tal value of excess June the total prul ids of base milk re- not to impede the delivery of nuclear t milk obtained in l aragraph a b > (1) of ceived; medicine services at smal! medical insti-this section by the total hundredweight Proposal No.12. Revise i 1011.74 by tutions or clinica. 6n exception would be of such milk and a djust to the nearest changing the word 1 " uniform price" to made for private practice in an institu.
, cent. The resulting , figure shall be the the words " uniform prices". Lion or chnic t,o allow a physician (si to
- l FIDitat REGilff t. V0t 4 2, NO 42-THutSDAY, MARCH 3,19r7 l
(
12186 PCPCSED RtRES bring byproduct material into a hospital or suggesUons for consideradon in con- , Fbr the Nuclear Regulatory Commis-(1) to administer radiopharmaceuticals nection with the proposed smendment sion. to a patient for therapeutic or diagnostic should send them to the Secretary of the SAMru J.Cutut. ( purposes, (2) to perform diagnostic Commission, UA Nuclear Regulatory Secretary of the Commissios. ( atudtes on patients to whom a radio- Commission, Washington, D.C. 20555 pharmaceutical has been administered Attendon: Docketing and Service f ra Doc.nene rued Mm,e:45ami or 13) perform in vitro diagnostic Branch, by April l8,1977. Copies of com-studies. The physiciants) would be re* ments may be examined in the NRC Pub-quired to remove from the premises, lic Document Room at 1111 H Street, [10 CFR Port 51 ] when he (they) departis), all byproduct NW., Washington, D.C. ENVIRONMENTAL RI PORTS SY CERTAIN materials except those remaining in the APPLH ANTS patient. As provided in I 30.34f c), the i 35.12 is revised to read as follows: licensee shall confine his possession and 5 33.12 S Lice' Sif4 use to the locations and purposes au, phy , pecifiefolicenae, h to u*e
- m. dividgal of 3- Notice is hereby given that the Nu-thorized in the license.) P" ] ne "Q uman clear Regulatory ('ommission is con-Institutions and Indfridual Practice. ca) An application by an individual ndering the amendrnent of its regula-
"The Manual on Radition Protection in physician or group of physicians for a uons in 10 CPR Pa rt 51. "Ihe proposed linspitals and General Practice," pub- specific ticense for human use of byprod- are amendments are of a minor natum or lished by the World Health Organiza. uct matertal will be approved if: procedural and clarifying changes.
tion i1974) in cooperation with the In- Section 51.40 of the Commission's (1) The applicant satisfies the general regulation ternational Labor Organization and the require nents specified in i 30.33 of this Poucy and "Licenst.ig and Regulatory Procedur s for Environmental Internat20mi ALa.C UnS7 A cepc7,0f- chapter: fers the following guidance: <D The application is for use in the Protection," 10 CF L Part $1. requires applicants for matsrials licenses issued nesponsibtuty for radtauon protection at. applicant's pw"& in an omcets) out* pursuant to 10 CFF Parts 30, 40 or 70, rects au members of the administrative syo- side a medical instauh which are covered br 10 CFT4 51.5f a), to tem, from the empicytng authortty to the (3) The applicant has accesa .,a s h.s* Indletdual carrying out a radiological pro
- Dital possessing adequate factisties w submit to the Cominasion 150 copies of n ,nyironmentai report which discusses cedure.
imamens inne unimately authority resporutble ta charge offor anytne estab' hospitalize and monitor the applicant's the natters describ*d in 10 CFR 51.20. radioactJve patients whenev*r it is ad*
- The propos.d aniendment of 10 CFR e ud e rna co hn visable; and
! e 51.40 set forth below would reduce the of any radtauon from its equipment. e4) The applicant has extensive ex* number of copies or environtnental re-I In context, this state'nent is used to en* perience m the proposed use, the han* ports applicable to Parts 30, 40, and 70 dhng and admtmstration of radioiso- heenses from 150 to 100 copies.
courage management to designate a per- topes, and ahere applicable, the clinical son in each department concerned with management of radioactive patients. The amendment >f 10 CFR 51.40 also ionizing radiations to take care of day- (The physiciants) shall furnish suttable would require that 15 copies of the en. to day protection measurest however, evidence of such expertence with the ap- 30, vironmental reporta applicable to Parta the admonition for management respon* plicauon. A statement from the medical 40, and 70 licei,ses be submitted to
; ssbihty and involvement in radiation the NRC and that :n additional 85 cop-isotopo conuntttee in the institution l tafety is regarded here as the goal for where the applicant acquired experience, les of the environttental report be re- g medical use and other radiation safety indicating its amount and nature, may tained by the app!: ant for distribution programs, to Federal, State .-nd local ometals in i
With this goal in mmd, the Commis* be submitted as evidence of such ex* accordance with wr tten instructions is-perience.) sion is proposing a rule change that sued by the Directo1 of Nuclear Material would, in effect, require a medical in* abi The Commission will not approve Safety and Safegua ds. an application by an individual physi. stitution, now operating a nuclear medl* cian or smup of physicians for a spe- Direct distributioli by the app!! cant of l cine program under an individual phys 1 etfic license to receive. possess or use the additional cop es of the environ-t clan heense, to be licensed as an institu' byproduct material on the premises of a mental report wouk materially expedite tion under i 35.11 at the time of ex* medical institution unless; the distribution of <uch copies by eliml-piration of the individual physician li- tte The use of byproduct materialis nating duplicate ha; dling of them by the cense obtamed under 6 35.12. In order for timtted to: applicant and the :IRC staff. This pro-a physician to continue to practice nu- all The administration of radiophar- cedure also would allevMte problems clear medicine in a medical institution maceuticals for diagnostic or therapeu- of the NRC staff w th regard to the re-he would have to be named on the in* tic purposes; ceipt, storage, asseinbly, and remailing i statutaon's license by the time his indi- sil) The performance of diagnostic of large volumes o ' environmental re-vidual physician license expires. At the studies on patients to whom a radio- E ris'
; expiration of the individual physican 11- pharmaceutical has been administered; Pursuant to the /tomic Energy Act of cense. the Commission would not renew or 1954, as amended, tlle Energy Reorgani-authorvation for practice within a medi- t 13: . The performance of in vitro ration Act of 1974 Ls amended, the Na-cal institution. Medical institutions diagnostic studies', ti nal r nmentd Act of M, ami which already hold an institution license 8 42) The physician brings the byprod- [#not ce is ereb gi n at dopi of evidual ph s c na to eri u- uct material with him and removes the of th'e following am< ndments to Title 10, tion license immediately, rather than byproduct material when he departs. Chapter f, Code of 3ederal Regulations, i wait until the physician's individual li- aThe imtitution cannot receive, possess Part 51 is contemp ated. All interested w
cense in effect,expires. Thethat provides proposed rule change, institutional 11- theor store layproduct material other than pel sons t[}ubm g, t wr
,d t amount of material remainmg in the o censes and individual physician licenses patient.1; and connection with th e proped amend-are mutually exclusive. ments should send t lem to the Secretary i Under the Atomic Energy Act of 1954, t3) The medical institution does not of the Commission,11 Nuclear Regula-t as amended, the Energy Reorganization hold a byproduct material license under tory Commission. Washmaton, D C.
Act of 1974, as amended, and section 553 l 35 11. 20555 Attention: D. cketing and Service of title 5 of the United States Code, no. t %- 161. Nb t sMo3. es stat. 944 e42 Branch, by May 2, 1377. Copies of 11te tice is hereby given that adoption of the tf s c 22at i: 9ec. 201 W h. tu 93-438. 88 comments on the p;oposed amendments following amendment to 10 Clit Part 35 mat 1243 m U a c ',a4 0 ) may be examined t the Commission's is contemplated. All in'erested persens Dated at Wuhingtim, D C. this 24th Public Document R2 om at 1717 !! Street who desire to submit written comments day of February,1377. I NW., Washington, D C. I FIDtfAt GEClif ts, vot. 43, No 43_gggg50Ar. MASCH 3, l977 el
1 a* GML15 AND REGULATIONS 17999 ' J l 907.767 Ma.I O enge Casaledes 407, larger eined fruit e ill be later than nor- Dated: March SI 1977, to become of. ' (b) Order. (1) 1 be respective quan-shal. D erefore, lhe committee has fer.uve AprD 1,187" . tiues af navel arma es grown In Are=rm, hmously rece unded that ne cur. Cu num R. Baassa, yent muireents fw papayas fw ex-and dealsnated par of Canfornip which Actiaa 2Nree nr,Freet and Fere. ., may be handled during the period ImM of at least 2 wau h I smde and g g i,g,g, j '7 April 1,1977, throu th Apr0 7,1977, are a weight of not les man le ounces each g,,g,g,,, g,,,ge,, j h weby Azed fob . set to expire on 3d krch 31,1977, be ex- , (1) District 1: 1] M.000 cartons; tended through Ma r 15,1977.During the Irn Doc.17-ecos FM S M *e8aml (u) District 2: St 1.000 cartons; remainder of 1977 papayas for export 1211 ) District 3: l'n11mited Movement are required to wel th at least 11 ounces CHAPTER XVtfl-FA RtKR$ N0tK ADMIN-each and grade a least Hawail No.1 (2) As used in th s section. " handled ISTRATION, DEI ARTtfENT OF ASRI-
" District 1," "Disti let 2." " District 3
- emcept that the told rance for defects is 5 W URE and " carton" have i be same mannMr as pucent instead of 4 percent. 1 M
4 IM L _,,a-when used in aald amended marketing It is further fma d mat it is impmeu- ) agra* ment and ords r cable, unnecessary, and contmry to me PART 1823-ASSO: TAT 10N LOANS AND public interest to sve pruitannary no- GRANT! "" **4ffY FAC8UTIES, DE. (esca.1-19. 44 stat. 8 . as amended. 7 UE c. uce. engage in pub he rnism W proce- we, m MAM N 883-' " I dure, and postpone the effecure date of TRON ; Dated: March 3C 1977. this amendment ur til 30 days after pub- , -
-g,,,,g , <
Ca; ums R. Baassa, - C 553 in tha e Actfaa Direct r, Frait sad Veae- between h dah h hfoemauon L-M Subpart g ,g ,/pge,- upon which emme av.n this amname pndment ume wmis based.be*aue . .,,Sub,part code . ,D L of,F,ar 3823.
,e,si Chapt.er oegula ,ns XVI,I,I 4
IFR Doc 77-elos 70 mt S-M-77.e;46 am) amendment must b come efective in or* FR 13210. 33 FR GEbO. 33 FR 9377) is de- , _ _ der to effectuate tJ .e dachred poucy of leted. Dame regubuans are ao longer
- the act is insufBeie it; and this amend- man ===ary asce t& program is no lans-
.IP* Pays Beg 1. Amuit. O sment reueves resta kctions on the han*
! ed. Exisung ===adamm loans for PART 928-PAPAYAl GROWN IN HAWAll dung of papayas gr mn in Hawall. er fund,i, mal saciusas will be headled in
,,er,,
Order He pro 1sions of I S28.307 accordance wuh psmeant mammenanity fa-(Papaya Regulation 7; 42 FR 1) are here- eGitans regulauens. AGENCY: Agricultt ral Marketing Serv- by amended to read bs follows: Delete the asteranoe to Subpart "D"ist toe, USDA. g 928.3e7 Papeye %egulatlen 7. 7 CFR 1823.251 lans 5. In i 1833.3&3 para. ACTION: Final rule (a) During the period January 1 graph (a) the 8,an11n paragraph (1)(1) lane 3. .
SUMMARY
- This bmendment relaxes through December 11.1977 no handler the quality and s11 r requirements for shall ship any con miner of papayas to (7 UA c. lose, deless son at authority by me Hawallan papaya.s 1 Mpped out-of-state any destination wl hin the production 8*c. of Act.1 cm ms: N taan of au-during the period A aril 1 through May area unless said pe >ayas grade at least '7,bM' Aest. I we. foe mural Develop-
- 15. 1977. It is lasujd under the Agricul. Hawail No.1 and au e of a size which in-tural Marketing Ag1 enent Act of 1937, dividually weigh noi less than 14 ounces: Effective date: 'I his deletion is effec.
as amended. and Ad krketing Order No. Provided. 'Itat pap 6Fas handled as Ha- tive on March 31,1 P77. s) 928. regulating the 1 andling of papayas wan Fancy grade sb bil be of a sine which Dated: March 11 1977* grown in Hawaii. Ir view of a delay in individually weigh not less than 16 the seasonal peak production of Ha- ounces. . Faan T '. Navtos, Jr., waiian papayas, tJ ,1s amendment is (b) During the period January 1 Actu P Administrator, needed to increase o e supply of papayas through May 15,15 F7, no handler shall Farmers No se ytton. available for expori to the benefit of ship any container < f papayas to any ex* (FR Doc.17-eees Ft og S-40.#F$46 amal producers and consu r.ers. port destination t 11ess sand papayas grade at least Haw Lil No.1: Propided DATES. To becomi effective April 1. .Ihat such papayas hhan be af pyriform' Title 10-Energy 1977. ahape and weigh no less than 10 ounces R l-400 CLEAR RESULATORY FOR FURTHER IN1 ORMATION CON ~ each. cot 4MtSSION TACT: (c) During the pe iod May 18 through PART 35-HUMAN USES OF BYPRODUCT 31, ,i o andM shall Mp RAATERIAI. Charles R. Brade Deputy Director '
- Fruit and Vegetab i Division. Agricul' tinau ess ai papayas grade a Group t.icenalng for Certain beedical Uses tural Marketing Si rvice. UA. Depart- least Hawa11 No.1, a cept that the allow. Notice is hereby stven of the amend-sn' W 20250 j2 b ashington, D.C. able tolerances for d ifects shall be 5 per- ment of the Nuclear Regulatory Cean.
cent: Protided, ni t not more than 3 mtantan's Regulauan, " Human Uses of SUPPL N FNTARY INFORMATION: percent shad be pq rmitted for serious Byproduct Material",10 CFR Part 35. Pursuant to the ma rheting agreement damase, not more ta nn 1 percent for im- Secuon 35.100 of 10 CPR Part 35 lists and Order No. 928 7 CFR Part 928), mature fruit, and n it more than 1 per. groups c,f medical uses of radioisotopes regulating the har fling of papayas cent fw decay: Prc dded further, hat that have similar requirements for user grown in Hawaii, effe 'uve under the ap- such papayas shad 1 e of pyrtform ahape training and expertence, facBlues and
, plienhle provisions a f the Agricultural and weigh not less 1 tan 11 cunees each. equipment, and redtstion anfety proce-Marketing Agreemtu L Act of 1937, as (d) When used hel tin "Hawa11 Fancy". dures.
amended (7 UA C. I )1-gi4), and upon "Hawmil ho.1" an " pyriform shape" he notice of peoposed rulemaking the recommendations of the Papa ~ya Ad- aha!! have the same manning as set forth that was puhushed in the Fassmat. Rac. ministrative Commiti re, established un- in the State of Han bli Revised Regula. Estra on January 21.1974 (30 FR 2384) o der the marketing as vement and order. Mon No.1 SubsectJ >n 8.32-Wholesale stated that the groups of Ilcensed uses ound Standards for HawaJ an Grown Papayas. would be amended from time to time to na All other terms ab hu have the same add new redlopharmaceuticals, sources, to efectuate the dec ared poucy of the act. meantog as when um d in the markeung dettees and uses as they are developed he esamittee res >rts that due to a agreement and eeder ne amendment to le CFR 38.100(b) delay in seasonal y ak productaan of (seen.1-18. es stat. si ne manended (7 Us c. adds indium 118m as ehloride for blood M*Wallan papayas, snple supplies of son-e74H , pool Imaging including placenta loes11-W - PEDeaAt beS18798, VOL 42, 8so. 62-7)evesoAY, alAaOI 31,19ry
'17100 MR25 Afe BEGULAfl006
.m - .h _ _ . s . _ . . _ - Agesptt forms with Group III, le CPR 36.100(c) GAATE]RAL TItATIO90 f*
In additaan, the Feed and Drug Ad. m e A Purenant to the Pbderal ansesy Ad-ministrauest (FDA) has approved a AGENCY: UK N icient Begulatory ministration's notic hy concerning the pub. ,1 "New Drug Applicauon" for technetium. Canun h mennan of FEA Fri and a9anaanan In-torpretations (431 R 70gs. Plehruary 8. 99m as =tann== pyrophosphate for car. ACTION: Final rule' 1977), appended h reto as an additional disc assagtng and this procedum is here. by added to Orots III.
SUMMARY
- he li uclear Regulatory Interputsuon issu d by the FEA OSco of General Couns i since issuance on Because these annendments relate Cran =laatan is amen ling its ngulataan (
molely to procedural anat8ers, the Coat- 10 CFR 7043(a), "n ate-tal Status Rap February 30.1977, c ! PEA Integretations manston has found that good cause es- parts." Form NI IC/ERDA-742 to 1977-1 through 11 77-6 (42 FR 14963
- j. tuts for omitting notice of proposed rule. change the reportina date from h. Pobruary 35.1977) asaking. and pubiac proedure thereon. as her 31 and June 30; to March 31 and FEA Interpreta& ma daPand for their un-ry. Stace the amendment re. 8splesnber 30 of eachyear. authority on the as curacy of the factual
, newes licensens fnen restrtettons under EFFECTIVE DATE: ' March 31.1977. statement used as 6 basis for the Inter-ngulations currecur in efect, it may POR FURTHER MbRMATION CON- may pretation (10 CFR 9 306.84(a)(3)) and become effective without the customary be rescinded o mod 18ed at any time 30-day nouce. TACI': *
(1306.86(d) ) . Onis the pereces to whom Pursuant to the Atonio Energy Act of Mr. Eugene Spark 6 N Divistosa of Interpretations art addmssed and upon i 1864, as amaanded, the Energy Reorgant- Wesuards. NM88 Washtneton. D.C. whom Intem na are served are en. i aatton Ar* of 1974. as amended, and Soc- 38656. F'IB 437-4 31 er commerical titled to rely on la mi (i 206.86(c)). An area code 301. Interpretauon is 1 =dmad by a suboe-tions 662 and 843 of Tlue 5 of the United States Code the following amendments SUPPf 8'arrNTARY INFORMATION: quent amendmasat I > the rosniathan(s) or to 'I1ue 10. Chapter I. Code of Federal Re UJB. Nt. clear R sulatory Commis. ruling (s) interpret d thereby to the es-Besulatione. Part 36 are puhltahad as a sics: (NItc) k ante iting 10 CPR 70.53 tent that the Inter pretation is taaanatat-d--at subject to codtScataan. (a), " Material status reports? De new ent with the ames dad rgulation(s) er
- 1. Sortion 36.100 to amended as fol- reporttna dates are 1 Earth 31 and Sep. ruling (s) (1 306.86 m)). In addenan, In-i terpretations am a lbject to appeal.De jous: Paragraph (b) is amended by teenber 30 of each yes *.
ahanens the pertod at the and of para- De Srst reporttri I date under this Interpretation app mded hereto is pub. 177. As of March 31. lashed today only 'or general guidance graph (36) to a semhmton and adding change is March 31. I the rnmaana set forth , o new paragraph (b)(37) and paragraph 1977, a report shall t t made for the pe. to accordance with sad above. I (c) (3) (1x) is amended to med as fol. rtod July 1.1976. thre sah March 31,1977, in the FEA Nouse c
- laws
- a nine month perto i. Dereafter. Ma- Issued in Washit ston. D.C., March 36.
8 35. Se eA p f medical 2 a f each c Ease J. Pycr. censive 6 months. A report is not re* Actine General Cpunsel. quired for December l 1.1976. Federalgne ys Adas4mistretion. l (b) Group 11. Use of prepared radio- nas channe ls na le because the UE. APP fNDlf
, pharmaceuticals for diagnostic studies Federal Government changed its nacal invoiring imaging and tumor localiza. Fear from July I tJ rough June 30 to ptember 30. N*. Te Desa cesseery 48ana October 1 through Bi e e e . e Inasmuch as the aJ tendment set forth s nature. good cause im Tees crey adat s.ine._ reb. ss Preen.
(37) Indium.113m as chloride for below is of a minor blood pool imaging, including placenta eEjsts for omitting notice of proposed g, Saen2iention. rulemaktng and publ e procedure there-(c) Group 111. Use of generators and
- on, as unnecammary.
y, D j. Inc Fursuant to the At imic Energy Act of awee esserpreted: it 11221.21242.31241. reagent kits for the preparation and use 1954, as amended, thi Energy Reorgant. Code OCW-FI-Dad duon of "Ftrm." "Be. am ; as mule. of radlopharmaceuticals containing by' sation Act of 1974, lad secuan 553 of product material for certa!n diagnostic titie 5 of the United a Lates Code, the fol. tomberas2.1976, ms in naponm to ywr tetter at sep. uses. in W Lloh you requested, on lowing amendment to Title 10. Chapter L behan or 'Isans city nea ntng. Inc. (-'rca-). Code of Federal Reg listions. Part 70 is an tnterpretattaa ed I sis s! of the PBA's (3) Reagent kits for preparation of published as a docun1 rnt subject to codj. petroleum pries Ng1 lanons. We interpro-techneuum-99m labeled; tauon ateo lavolves be deantuon or -arm" e e e e e Scation. and "reener"in ll 21 IJt noe 213.e2.
- 1. Section 70.53 is a nended as follows: , ,
5 (la) Stannous pyrophosphate for bone and cardisc 1maging. $ 70.53 [ Aseended] g. .rca is a aes reener" and an in.
* * * *
- In t 10.53. paragras t:(a) 3ndsentence dependent renner < m tame terms are de.
a in CFR Effective date: These amendments be- la amended by dele' ing " June 30 and , tag c obe*k b come otractive on March 31,1977. December 31" and tna sting in tied there. Agway Petroleum C ep. ("Agway Petrote. ' m-). m purenasi i crude oss trem mapr (seca. et. aetb. Pub. Law as-702, as amended, of " March 31 and Bel te.nber 30.o 011 companies as m I as independent pro-e5 Stat. OsS. Det (42 UA C. 21:1. 2201). ' (sec.101. Pub.1. B ' 30. Os Stat. 948 (as ducere. It nous appr1 timately 80 percent or Soc. act. Pub law SS-4st, es amended. 88 US C. 2301; ese. Sot) Pub. I. 96-434, as sta rennery output i > Agesy Petroleum. stat.1242 (42 UJa c. aest).) stat.1M2 (es US C. I le t ) . ) 2. Aswer Petroleus , is engesed in remetung
- Dated at Bethesda, Md this 23d day of Dated at Bethesda, Md., this 22nd day '*rtous petroieum pr duos in the Northeast.
sately es nereens or its It purchnees appron March 1977* if March 1977. petroleum products 1 om TUR. Agway Petro. For the Nuclear Regulatory Commis. For the Nuclear 1 egulator Commis. leum is a whetty.own at subeldiary of Agway, sion. Inc. (- Asway"). sion. s. Asway is an a prtcultural cooperauve Ims V. Oossten. 1 Bs V. Ocastem, r for Operations. whane acanmon vous i eseca la ownee ey ap. frecuttre Director for Operettor:4. Excestice Direcid proalmately 110,000 i brmere in sto operoung IFR Doc 77-9720 Fued S-40-77,8 es am] [FR Doc.77-4722 J'llei S-80-77,0 44 am) area, the nortasestai n etates. It la engaged PtDisAt BEGilitt. VOL. et. Dec. 4 LfleWat0AY, anASCM 31, tery e
. I a F.ULES AfD LFGt!!!al0NS ::UJI
% " ~
1 T.t> 10-Jm igy ' .t l . ** I t ~ A 11 . r
. ' N ' '!
1 In u s 'i lT
. rt t.e '.8 g 31.11 1 * ,a uf ,1) o.n 1 f.y t '.e r .nl r + "ng CHtJH R I -f;tWi t I R IMtR ATORY ,,
W."." P O N M ' '" ' r n 215 Wm. G <a ) .
- 3. Footnote 3 to i 315 of P.o t 31 b
, cM rir mtNtrs och ted .
'da s .c is
.d!" w i 70 22 i O , . f. d l Rtport:rg and ft c ord W t Nrg 131.11 to :( d t s itJ:02 s: $ ;o,,,7 g g n,, n.frd]
re quNtm rets n.rc --ne cpc
- n g a' d rt " rd 1. , 't.c g 79..,9 g g,,, g,a y AUDCY. Nmb ar nieu! tory Commis.ic.n re e;;r scr. tes .t abyad in itm s,.s t : .a e 6 70.71 [ Ami n.l. dl t e 04 : t rat Aw.t u.g Hon. o Tce u der D l m a a v u ). t hM t.o b 12. Pu.,t ncte I to I 70 22. fc ~t' - t e I to A(" TION: Final rule. t
[ l D R fd. .te 2 to i 10.t9. u.d the note WM'.* A RY: Tbc h tcar Recu%ry
- at the ad of 17011 are C h *t J and a 1
C:.r. - . Mon !? u : r9.g its ugulaPns S 32.110 [h n fed) imte i< .Md fo:!ning i 70.7110 :od as l
' v ht:h include @rting or secord ktcp- 4. rostnote 4 to i 3:151 of Part 3215 f c !bu s:
' 1:g rc whi:amts mS.;t<t to cleat ance by c';1cted at:d a note is addrd to:lov.ini!
.ny ,_g, ,, y rting and re.- ed 'b u ring t!.c O m ral Accounting 05ce. The ! 32 110 13 rt.ad r.s fellows: r q arm nts u.nt .tr.e1 in this 5 .r t ime Norr-ne reporting and rer.rd ko;ta.g L en s4;racd by the oe:.eral Arc. uting j
m.(:. h:4nts add Imtations, or up.date cWee t: . & r B 1S?225 ( R 2M1), qu0172). j r s!'ung notaticns, which state that the re pe r.ents ecntatt.ed in this p:>rt !.n e 9.!vflh W > M ). uportb.g or ruu:d keqing rup:!:cmmts twen apprued by the co.eral Am ung h.ue b(en app;oved by the Gencral Ac- oc.:e under B.1N225 tRw3sn g 71.61 ( tme nded) J (ciunting 0"lec. and indude the antro- t 33.100 [ ime nite d) 13. The note at the end of AII(nCx priate OAO crprotal nutnber. 'Ihese E of Part 71 is deleted and a note is added ranendments t.re reautred in order to 5. A note is added icilowing i 33100 of owing i11.64 to rcad as follows: ? conform with the tcrulations of the Part 33 to read as fcl:ows: Nutc.-ne rep:rting and record he*p ng Ocuct al Accountir.g Ofr.ce "C!carance of '
' "" * * "'" ' "' # I"
- M' M * '"
- prvpels by indcpenct<nt Federal regu- re re rn s b I[r.7d i tNa .irt e
$f,"*[ er$ ^ "
latory agencies to conduct h been appued by the cencrat Ac cmr:ttng 5 R to!!t(tion of informat!an.,orThe tponsor te rim <nd- omce under B-tem 5 tRN85p. rc.t nts v111 furnbh curre ntly (!"ective in. i 73.20 [ An.re.Jrd) formatvan reprding OAO (Icarances of g 31.51 ( tm. nde d) 14. A note is added folbwing 173 80 NRC reporting and record k<eping re- 6. A note is added f a:!owing i 24 S1 of Part 73 to read as fo!!ows: l quittme nts. of Part 34 to read as ic.!!ows: Norc-ne rep;rtirs and record leeping IRECTIVE DATE: May 29,1977. Note-ne repct!!ng and rea rd keeping reccurer-er.ts cor.tened in this part I.n e rcQu!re:nents con *alsed in this part 1,:a c teen a;; rued by the Ger.eral Accountir.g FOR FURTliER INTORMATION CON
- teen ap;nned by t'.e on cat Am.r.in.g o%e uncer s .iem5 inr39).
1 TACT: o*.ce under B40025 than2). (Bc335). g I 10.90 f .t na nded) Gerald I. Hutton, Division of Rules $ -35*100 ( A ""-"'le'd) 15. A nate is addM folloaing i 140.90 i and Reccrds,05cc of Admin!<tration, 7. A note is added fc!!osing I 35100 of Part 140 to read as follows: U.S. Nuclear Regulatory Commluton, Nore -ne reperttog and record becptng i Washington. D C. 20355, 301-4t42-7211. of Part 35 to read as fo!!ows:
4"I" *'"* * "**hd 8" *hl' P"
i SUPPLEMENTARY INFOR MkTION*. Wre--ne reporttr:g and rc:ctd Kerring been appraed by the Ocneral Acccunting
- requireme nta ec ntatt.ed in this part hue one under n-seo225 (Rolts),
Because thete emendrnents relate to!ely dun sp;rmed by the cerat Amnung to minor matters, g@d cause exists for Of*.ce under B-36')225 (Ro3f 8). (RN34). E 110 30 [ Arnended] cmitting notice of lcropaed rule making. 16. A note is added fo!!owing i 150.30 and pub!!c procedure thereon, as unnec- g 36.50 t Amc ided)
- 8. A note is added following i 36 50 of of Part 150 to read as fo!!ows:
cuary. Since the amendments do not Nott-ne repcrting and record keeping impose cthrations on renons other than Part 36 to read as ic!1ows: requirernenta ecntarr.ed in this part have the Nuclear Regulatory Comtrdssion, the N n-m up rung and neerd koptr.F teen appresed by the oeneral Acccunting CommNion has found that good cause h*"
"WWEt* C M*1"d in t 18 F$tt exists for making the amendments ef. t.een ap; cred by the oenerat Accc2unting os,ce t
43 3* under D-tems (Ro040) tRooiO). (R) fectne immediately *1thcut the custom
- OSce ur. der n-Is]225 anoo30).
ary 30. day notice. Ef*ective date: These amendments Pursuant to the Atomic Enerry Act of IIM3 I A"" nded] . become e5ective on May 19,1977, 1954, as a*r. ended. the Energy Reorgani- g 10.90 [ Anu nded] isec. let, es stat. 948 (42 Us c. 2201: sec. -
"I* se stat.1242 H2 p c. oselm ration Act of 1974, as amended. and sec . 9 Footnote 1 to I 40.65 of Part 40 la dented and a note is addM following Dated at Bethesda, Md this 11th day tate C e the Ing arr d, of May 1977.
to Title 10. Chart . Code of yYderal I 40 90 to read as fo!!ows: For the Nuclear Regulatory Commis-u:ations. Parts 30.31,32.33,34, Non-ne reporting and record tecptng 36, 40, 50. 55. iv, , . 73,140, a".d 150 requiremer.ts ecntained in tr.ts part have ston. Lrt V. Dessicm a
. pubhihed as a dxument subject to treen approed by the oer.eral Acceunting Erreuffre D.rcefor for codif. cation. cece un.ter B-18m3 t Rot:8). (R0t47). Opmons.
tRo233h (Ro413h (Rmoh F i 20.60i f Ame nded) Im Doc 77-14231 m3 Mem.s'45 arnt t
- 1. The nete at the end of Arpendix D g 30.33a [ (mended )
of Part 20 is deleted r nd a note is added gSu3 [Anu mied) Title 14-Aeronauns and Space fo!Icuing l l'0 601 to trad a.s follows: 110 Ame n&d] CH APTER l-FEDERAL AVIATION AD!/IN. 1 Nort-ne reperting and recerd keeping ISTR ATION, DEPART MENT OF TRANS-requirertents contatned in this part bare 10. Foetnote t to ! 50.33a. footnete : to PORTATION t+,n approsed be the Genera! Accounting 150 65, and the note following 5 50 110
- 10 Let No. 76.rA-e! Amdt 39-28s5) ut. der B-180223 (R0043). tRo044 h and of Part 50 are deleted and a note is added folloalns i 50110 to read as follows: PART 39-AIRWORTHI 4ESS DIRECTIVES
- g 30.71 I tmended] "*
- 2. A note is added following i 30.71 of 8" " # "8 ""8 "
- d ""E'"8 -
N ,'p*p'rN*ed by b o'e"ne'r Aecoun F" AGENCY: Federal An ition Administra-j Part 30 to read as follow s: s' tion. DOT. g, Non-ne reporting and record keeping 05ce under B-tho228 (R>o71). requirements contained in this part here ACTION: Final rule. t+en approsed by the General Acceunting $ 53.60 [ Amended) t *' ome ur.cer m.tems tRoo79), (Roces), one !!. A second note is added following
SUMMARY
- 'Ihis rule # ADI requires an Inspection for cracks i the rnaln land-
, tho173). ! $5 60 of Part $$ to read as fo!!ows: . i notent eroistan, vot n. No. er twunscar, par te,1977 J
- PRIPOSED RULES
, 25743 DEPART AENT OF thin be assembled and reviewed C.nd an FVR PURTIIER INFOlih!ATION CON.
TRANSP( 'RTATION industry response prepared and ap- TACT: proved. Federal Railroa 1 Administration In order to enab e the AAR and other hirs. Patricia C. Vacca Division of Fuel Cycle and Material Safety, Of!!ce k [49 CFI 'Ch.H] commenters to pre are and submit com- of Nuclear h!aterial Safety and Safe- s l Docket No. RSC- i6-6; Notice No 2] prehenshe comme its to assist FRA in guards U.S. Nuclear Regulatory Com-this proceeding, ti e period for filing of mission, Washington, D C. (301-427-MINIMUM SAFETY tEQUIREMENTS FOR written comments ,s hereby extended to - 4232). 6 11All.nOAD 1 :ABOOSE CARS August 1,1977. Cor iments should be filed Adrnce Notice of I 'roposed Rulemaking; on or before that d ite, in trip!!cate, with SUPPLEhfENTARY INFORhfATION: 5 Following its organization under the Extension of T Tie to Comment
' ^ Energy Reorganization Act of 1974 (Pub-de a 1 oa' dmin att 40 3~ "
AGENCY: Federal : (ailroad Administra. Seventh Street 81/, Washington, D C. gn N tion. DOT. 20590. h sta } tion of reviewing those of its regula-ACTION: Extensio i of comment period (Sec. 202 Federal Ra troad Safety Act of 1970 tions and procedures pertaining to the t i for cdvanced notice of proposed rule- [ 43y *("'"d DFg,6 , licensing and regulation of nuclear fa- i l Act of 1976. Pub L 1 4-348. Do Stat. 817, July cilities and materials that were origi-making. e l SUMh!ARY: On As til 13,1977, the FRA e. 1976. Ia.49ln) of the regulations of the nally promulgated by the Atomic Energy Published in the l' Lorn 4L Rectstra (42 OfBce of the Secreta y (49 CFR 1.49(n)).) Commission. with a view to considering
. FR 19359) an ANP;Gt corcerning mini- what changes should be made. In this Issued in Washh gton, D.C.. on hf ay 13, context, the Commission is currently re-mum safety requaiements for railroad 1977. viewing its regulations pertaining to the ciboose cars. The 1 arpose cf this notice R; ymoNo K. JAurs.
human use of byproduct material in-b to extend the p<riod of time for the Chief Counsel- ' cluding teletherapy units. public to submit ' less and comments on this ANPRSf. Ad/ 11ed 5-18-77; 8:45 aml Byproduct material licenses are issued on the basis that the licensee is quah-DATES: Written c imments must be re- NUCLEAR REGULATORY fled by training and experience to use ceived on or before s ugust 1,1977. 3"5'd *"'"*"I'"8"Ch **""" *** C 0N protect health and minimize danger to
' ADDRESSES: Sul' mission of scriffen com ments: Writte i comments should [ 10 CFR Part 35 ] life or property. Imp!! cit in the issuance identify the docket number and be sub- HUMAN USES OF BYPRODUCT MATERIAL
- n hat basis is e o a t tr aca et e cept at e1 c g e a
Human Uses of Teletherapy Units aware of the accepted standards of prac-r,oad Administratio 1. 400 Sesenth Street AGENCY: U.S. Nuclear Regulatory Com- ce t "d uW.. Washington,1) C. 20590. e a idra t pro h rt mission. i Enmination of ; riffen comments: All ACTION: Proposed rule, sufficient to ensure that the beensed material is used in accordance with NRC bl irea i t n bo h efore a SUhth! ARY: The Nuclear Regulatory gul tions and accepted standards of r l, citer the cloamg date for written com- C mmission is proposmg to an end its In the area of teletherapy, existing b s1 ments, durmg reguMr bustress hours in regulations regarding human uses of by- g g Room 5101, Nassif .3uilding. 400 Sesenth product (i e., reactor-produced > mate. g p Street SW., Washir ,; ton. D C. rial in teletherapy units. The proposed
<l rule requires teletherapy licensees to: (NCRPs Report No 33. hfedical X-ray FOR FURTIIER I? PORh!ATION CON- 1. llave a cualif ed expert perform full and Gamma-Ray Protection for Ener.
TACT. - gles Up to 10 hieV-Equipment Design l calibration measurements on each tele- and Use," American National Standards Edward F. Cor way, Jr. (202-426- therapy unit at least once each year; l ,8836'- Institute. Inc. (ANSD Pubhcation N449-
- 2. Perform spot-check measurements 1974,
- Guidelmes for hiaintaming Co. l CUPPLEhfENTAR1 INFORhf ATION: on the output of their units at least balt-60 and Cesium-137 Teletherapy '
l monthly; and Equipment" and the criteria for accredi-
, Bacxcs ot N< IN rod u 4TroM
- 3. Report to the U.S. Nuclear Regula- tation of the Joint Committee on 11o.-
, On April 13.19 7, FRA published in tory Commission radiation doses that pital Accreditation.
the Ft: raat Rtcast 'n an ANPRh! sohcit. diff er f rom prescribed doses by more than Despite the existence and general ac- 3 ing views and comr lents from thi. pub!!c 10 percent. ceptance of these standards, recent evi-
~
reg:rding the nece: sity of, and the costs The proposed rule is needed to ensure dence indicates that a sigmficant num-Cnd benefits to be < erived from issuance that teletherapy units are properly call, ber of teletherapy units may deliver a cf Federal regulat ons requiring mini- brated. The proposed amendments are radiation dose that differs from the pre. ,
~
y mum design specift ations and perform- designed to ensure that patients can re. acribed dose by more than 10 percent. j cnce standards for railroad cabooses (42 ceive the correct radiation dose and to (With proper calibration, the radiation - [ FR 193598, present recurrence of overexposura ou% of a teletherapy umt can be de-f Comments were requested to be sub. events due to improperly cahbrated tele. teruined with an uncertainty of less mitted on or befor Kfay 30,1977. The therapy units. than 3 percent.) The evidence also indi. li Asscelition of merica Rail 'd ents must be received by cates that up to five years has elapsed 4AAR) has petitio Ied for an exte sior g - since the last cahbration of some tele- p cf tim? within wi ich to submit com- J y therapy units. mints. In order to 1 ally answer the ques- ADDRESSES: Written comments or The Commission has conducted an in-tions asked in the <LNPRh!, AAR and its suggestlans for consideration in connec. Vestigation of a recent incident in which member railroads a e examining in depth tion with the proposed amendment approximately 400 patients treated for cf c,v-11able inforn ation concerning ca- should be sent to the Secretary of the cancer with a cobalt-60 teletherapy unit booses. This infor nation will then be Commission, U S. Nuclear Regulatory received radiation doses that exceeded compiled. reviewed and digested by per- . Commission. Washington, D C. 20555, the prescribed doses by as much as 41 sonn;l cf various d sclplines within rail. Attention: Docketing and Service percent. This incident occurred because . road mechanical ai d operations depart- Branch. Copics of comments received the radiation dose rate from the tele-menta and will a 15 0 be studied and will be available for public inspection at therapy umt had not been properly reviewed by railrtx d safety of".cers and the Commissionis Public Document ' Gnvironmental coo a ter its investigation, the Com. dinators. 'Ihe prod- Room,1717 H Street, NW., Washing- mission took actions to ensure that all I uct cf all of these working groups will ton, D C. 20555. teletherapy units licensed by the NRC IIDit At ef Gilf f s, VOL. 42, No 97-THUtlD AY, MAY ~19, 1977 b
_ --- -- -_~ _ - ..- ,_ - f
- PROPOSED RULE 5 2*,7 l l trquired by parneraph sbi(4) of this ihe al s Any licenu e uhre is authmbed inere properly rnlibiated The Conums- section shall bc twrformed and es esta nluatul b-to use telethetapy umts for human uso in accordance with proceduirs ston behetes that these acttons w cre mic- shall cause full en!Wrntion rncasure- Itshed by the quallfled expert The auah.
qunte to prevent recurrcnre of oscat s- turnts on each teletherapy unit to be fled expett shall teview the results of posure events due ta unproperly tah- pei fot med - spot check measurements and shall rec-brated units durmg the time required to t o Prior to the f5t tue of the umt for ommend cortectise action when signifl- -I implernrnt necessary changes in its treatmg humans, regulations cant d1Merences are noted illi Whenever the radiation meter or #6' When measurements made pur-llerause of the events described abote, other denice aclated to radint!on outpat suant to paragraphs Ibitti and abi(4i it uppenis th:.t the Comminton should hows a contmued significant change in of this section indicate that patients Impose such cotittols as are ner essary to its normal readmg. treated by teletherapy units may hate ensure that teletherapy units continue to ihh Follawing replacement of the ra- rtecived a nadiation dose differing from be used in such mam cr as to dehrer dmtion source or following reinstallation the prescribed dose by more than 10 per. radiation doses that are not sigruficantly of the unit in a new loention nnd prior to cent, the bcensee shall notify the appro-different from the does prescribed hv the the use of the unit for treating humans, priate Reglotml Office of Inspection and phssician Accordinclv. the Commtwinn invi At mtervals not exceeding one Enforcement hsted in Appendix D of 10 is ptoposing an amendment to i 3513 to year. CFR Part 20. and. u here practicable, the reouire that a quahfied expert perf orm #28 Full cabbration measurements referrmg physicians of affected pntients. pet todic full cahbration measurements shall mclude determmation of: This notification shall be made within 24 ami mablish monthly soot-chm k prtce. eli The exposure rate or dose rate for hours af ter the licensee's discovery that dures in necordance with accepted stand- the ranse of field sites used and for each such misadministration is likely to have aids The proposed regulation defines treatment distance used by radiation occurred the quahncations of the expert the the rapv ; ' rutasurements to be made, tht f recuency slii The congruence between the ra. 47: The licensee shall maintain for inspection hv the Commission iccords of and circumstances under s hich the diation field and the field mdicated by the measurements made pursuant to measurements are to be performed and the locahzing device when localizing de. paragraphs abille and (b)(4) of this the procedures to be used. The proposed vices ate used; section and of reports made to referring amendment also requires that brensees 8i11' The uniformity of the radiation physicians pursuant to paragraph (bl(6) notif y the U S. Nuclear Regulatory Com- fic!d and its dependence upon the direc. of this section. mission when their measurements indt. tion of the useful beam; ici pub L nL701, 68 stat 948 (42 cate that patients treated with tele. <tv> Tamer accuracy. (see therapy units may have recetted radi.>- t/ S C 220t n See 201. pub. L 93438. 88 Stat.
#38 Full calibration measurements 1243 (42 (J.S c. 5841) )
tion doses differing f rom the prescribed shall be made in accordance with the do'e by more than 10 percent procedures recommended by the Scien- Dated at Washington
- D C', this 17th Pursuant to the Atomic Energy Act of tific Committee on Rndiation Dostmetry "I "I 1954. as amended, the Energy Reorgant. of the American Association of Physi. For the U.S. Nuclear Regulatory Com-ration Act of 1974. as amended. and Sec- cists in Medicine iPhysics in Medicine tions 552 and 5:3 of Tttle 5 of the United and Biology, Vol.'16. No. 3,1971, pp. 379- mission.
States Code notice is hereby citen that Smt'tL J. CutLK. acioption of the following amendment to 3968.' 848 Spot-check menstnements shall be Secrcf aru for the Commission. 10 CFR Part 35 is contemplated performed at interval., not exceedmg one (FR Doc.77-14421 Flied 5-18 77.8:45 anal In addition tions on the to comments merits of theand succes. month and shallinclude: proposed ti' Determination of timer accuracy; ( 10 CFR Parts 5),70, and 73 ] amendments, the Nuclear Regulatory ah5 Determination of congruency of Commission also wants to receive com- the useful beam with the light localtzer: %UCENSING OF PROD JCTION AND UTILI-SPECIAL NilcLEAR ments designed to clarify any possible ( till Determination of the exposure ZATION FACILITIES ambiguities in the rule. All interested rate. dose rate or a quantity related in a MATERIAL: PHYSICAL PROTECTION OF persons who destre to submit written knmin manner to these rates for one PLANTS AND MAT :RfALS comments o succestions with regard to typical set of machine operating condi- Licensee Safegua.r.ds Contingency Plans the proposed amendment should send tions; them to the Secretary of the Commission. <ive Comparison of the measurements AGENCY: Nuclear F egulatory Commis. U.S Nuclear Regulatory Commission. made in Section 81115 of this paragraph sion. Washington. D C. 20555. Attention: uith values calculated from physical de. ACTION: Proposed 1 ule. Doc keting and Sertice Branch by Julv 5. cay of the radiation source. 1977. Copies of comments on the pro-
SUMMARY
- Under the proposed rule.
(5s Cahbration measurements re. licensee authorized ia operate a nuclear posed amendment may be examined at quired by paragraph (b'(Is of this sec. reactor sother than i ertain research and the Commission's Public Document Room tion shall be performed by a quahfied test reactors) and hoe.e authorized to at 1717 H Street. NW., Washington, D C. expert such as an individual certified by possess strategic quaatities of plutonium 20555 .the American Board of Radiology in or uranium-235 wou'd be required to de-I Section 35.13 is amended to read Therapeutic Radiological Physics. Radio- velop and implemelit acceptable plans as follows: I gical Physics. Roentgen Ray and f r respondmg to 1hreats, thefts. and E 3313 %per.fer
. i licen.c. for h,unian u c Gamma Ray Physics or Lray and sabotage of license ( nuclear materials of b3 prod uct material in acated Radmm Physics or an individual who and f acihties. The i.lans are needed to
" " ' *
- has equivalent qualifications i A descrip- ensure a structured. orderly, and timeb
'a5 An apphcation for a specific h. quahfications tion of the quahfied expert's trainmg and response to safeguar4Is contingencies and shall be submitted to the are integral with ot :er safeguards con-cense for use of a scaled source for hu. Commission for review. If the quahtied tingency plannmg tctivities being car-man use will1:e ap; rosed if- expert is certified in one of the specialties ried out as required by statute. Licensee i1i The applicant satisfies the gen- hsted in this paragraph only a statement safeguards continge' .ey plans would re-eral requirements specified in i 30 33 of of that f act and the date of certification suit in organizing I censees' safeguard
- this chapter; and is required i Spot-check measurements ** "" " "I " I" """
82> The applicant or, lf the apphca- ym M a sah maMs conhgency tion is made by an institution, the indi- i This incorporation by reference provision the responding par ;icipant8 would lx vidual user. (1) has specialized training * ** *ppros ed by the Acting Director of the identified, their set ?ral responsibilitie' in the .herapeutie use of the radioactive Fedent Regism on August 6.1976 Coptes
, device tonsidered tteletherapy unit. beta ^
DATES: Comments Tiust be received or ia nt'to s h' t in g an 11 a he DocunwM Roont 1717 H Stmt. Nw,
% ashington. D C. 3o555 or betore July 18.19' 7.
physician-FIDit At REGISTER. VOL 42,-NO. 97-THUR$D AY, M AY 19, 1977 4
a PROPOSED RULES 3G268 [10 CFR Part 35 ] wtse render unidentitlable am empty radioactive radio. HUMAN USES OF BYPRODUCT MATERIAL Committee, established under the mar- symbols or labels I keting agreement, as ded amended. and Human Uses of Teletherapy Units; (7 CPR Part active material contertners prior
; ton is not to dis.
feastble Extension of Time to Comment Order 917). This No.market 929. ng as ai ten agreement and aposal, to attach placardand c if such acr label bearmg the AGENCY: U S. Nuclear Regulatory Com order regulates the handling of cran-berries grown in the Statesof Massachu-Notice the petit on for rulemaking mission. word "ofempty'*. setts, Rhode Islanc . Connecticut. New 8 Docket Number PRNi-20-8) was pub- ACTION: Extension of comment period Jersey, Wisconslu ? Itchigan. Minnesota. 11shed in the FEntRAi REcts7tn on Feb- on proposed rule. Oregon. Washingtor . a nd Long Island in ruary 22,1971 142 f R 10377: FR Doc. This notice extends the th3 State of New 5 ork, and is e17ective 77-5354. filed Febrts y 18.19778. Pubhc
SUMMARY
- comment period on a proposed rule provisions of the comments were sob :lted by April 25, " Human Uses of Teletherapy Units." that under the applicat; e g Agreement Act 1977 was pubitshed in the FEDERAL REctstra A2ricultural Marke (in7 U.S C. 601-674).
of 1937, as amende' Containers bearing radioactive ma- (42 FR 25743) cn May 19.1977. Under the propos 11. the provisions of terial labels are som( times found in in. Comments must be received by paragraph ta) of I! 29217. Expenses and appropriate locatioi s (e g., garbage DATE: rate of assessment (41 FR 47457) are dumpss. Notification of such finds are July 29,1977* Pederal regulatory ADDRESS: Written comments or sug-rzvised to read as fo!(ows: made to State or la. pew . and rate of assen- agencies responsible br radiation safety. ge:tions for consideration in connection
$ 929.217 An investigation is nade for each re. with the proposed amendment should be expenses that are ported incident by thi responsible agency sent to the Secretary of the Commission, (r.) Expenses. Tll: to be incurred by requiring the expend. Lure of many man. U S. Nuclear Regulatory Commission, reasonable and like y these containers Washington, D C. 20555. Attention:
the Cranberry M.rketing Committee are hours.empty, The majority,nated uncontam )f do not con. Docketing and Service Branch. Copies of during the fiscal t eriod September 1. 1978. through Au ust 31. 1977,fore willdotain any radloactive not present itny hazard toi Taterial the public and Ihere. inspection comments at the received will be availab Commission's amount t0 $70.908.0: public. Public Document Room.1717 H Street Dated: July 8.197 The requirement t< > destroy or deface NW., Washington, D C. 20555. t the radioactlVe mate 'lal label on empty CH4 <Lrs R. BRADER, containers prior to t bposal will reduce FOR FURTilER INFORMATION CON! Deputy Direct 3r, Fruit and Veg- the number of requ red insestigations TACT: etable Diti don, Agriculturaf and thereby save ma: y manhours. Mrs. Patricia C. Vacca, Division of Fuel Afarketing iertice. Pursuant to the At >mic Energy Act of Cycle and Material Safety, Omce of d 1-ts-77;8:45 ami 1954. as amended, T' te Energy Reorga. Nuclear Material Safety and Safe. [ FR Doc 77-20283 Ft e as amended and guards. U S. Nuclear Regulatory Com-nization Act of 1974 of Titte 5 of the mission. Washington, D C. 20555 <301-Sections 552 and 55; NUCLEAR F EGULATORY Unated States Code, u efollowing amend. 427-4232), COMM SSION ment of Title 10, Cha iter I. Code of Fed-eral Itegulations, Pa -t 20 is published On May SUPPLEMENTARY 19,1917, the U S. Nuclear INFORMATION: ikgu. [ 10 CFR Part 20 ] OTECTION AGAINST for public comment. latory Commission published in the Fro-STANDARDS FOR PF All interested pers ans who desire to HAL REGIsTra (42 Fil 25743) a notice RADl/ TION submit written comm ents or suggestions proposing amendment of the Commis. R:moval or Def ac ngof Rarloactive onnection with the for considerations in i should send them alon's regulations "liuman Uses of By. Miterials Labeis or Empty Containers prop sed amendment aclear itegulatory by Auttust 29,1977 t) the Secretary of product Matertal,10 CFR Pa'rt 35 by AGENCY- U .S. t 4uclear Regulatory adding a new I 35.13(b). Interested persons were tnvited to sub-Conmtission* the Commtssion. U.S. i a Commission, WashingLon D C.20555. At- mit written comments or suggestions on ACTION: Proposed 1ule. tention: Decketing al <d onService Branch. um proposed amendment by July 5.1977. the proposed BUMMARY: The Juclear Regulatory Copks of comments may be examined at the requests in ticw of several formal and informal Commlaton la protming to amend its amendment,a Public ;Mcument Room at to extend the comment period, regulations establti ilng standards for Commission Including a request from the American protection against radiation hazards 1717Paragraph H Street, NW.,1(ashington, D C. (f) of I 20.203 is amended Board of Health Physics, the U.S. Nuclear Erising out of NRC teensed activattes to > paragraph (4) to Regulatory Commission has extended the require the removal defacing or other- by addmg a new su
- wise rendering unidt attflable radioactive read as follows.
materials labels ori empty containers 8 20.203 Caution oli no, labels, signals, Dated at Washington, D.C., this 8th prbr to disposal. and control,' day of July 1977. DATES: Comments nust be received bY * * * . For the U S. Nuclear Regulatory Com-August 29,1977. ' (f) Containers
- mission.
* * *
- SAuvrL J. Curtx ADDRESSES: Comi tents must be sent *
- hall, prior to dis- Secretary for the Commission.
to The Secretary a f the Commission. (4) Each licensee U S. Nuclear Regu atory Commission, 20555, Attention: posal of an empty un :ontaminated areas, removecon- or iFR Doc 77-20320 Ftted 7-13-77.8;45 aml Washington. DC.rs tamer to unrestricte t - Docketing and Se cce Branch, def ace the radioactiva material label or therwise clearly indl: ate that the tbn- [ 10 CFR Part 50 ) FOR PURTIIER INI ORM ATION CON- tainer no longer coitains radioacthe LICENSING OF PRODUCTION AND TACT: Dr. Lewis Battist, Omce of Standards material. of Structures, Sys. Development U.S. Nuclear Regulatory (Sec. tot Pub. L. 83-7 i3. 68 stat. 948 (42 Maintaining Integrit) >nents important to Commission. Wast mgton, D C. 20555, U s c. 2201); sec. 201. Pt b. L. 93-438,88 tems, and Comp Stat. 1242 (42 U S.C. 5841) .) telephone 301-443 6900. ts Dated at Washing' on, D C., this.7th SUPPLEMENTARY INFORMATION: ' The Department o Mihtary A3 airs, day of July,1977. For the Nuclear Ri gulatory Commis- C """ ** "' Altska Disaster Oft :e, by Ictter dated ACTION: Proposed rule. January 26, 1977 equested that the alon.
, SA actL J. CHILK, Nuclear Regulatory Commission amend Ls regulations, spe- Secretaq/ of the Commissio's. SUMMA!W: The cifically 10 CPR 1% t 20, te require !!. Commbslon is cons dering amending tta IFR Doo.7Noooo Fue .1-13 -77.8.4s ami ctnsees to obitterate. mutilate or other-FIDER AL RIQt$tte VOL. 42, NO.135 THUtlOAf, Jutr 14,197r
- m
't1
y,nt) RULES AND RIGULAllONS I tion 883 of Title 8 Tf the Unhrst Hinten inny crane ulthln tonne of rnalintion I hr* rulo rheinre util hnge n enininml ' code. from Ita nettvitten. effect uti phulcinns u hn hold Indhldunt Arcordinsdy. pui' 'intit in ihn AlumIf g .g.g. g g,;. g .g .. g . g g g NIN ' fir Hi m thnt rin e rntly su d hnt lm Ener gy Act of Ifrt ns amemlnl the prnrtice in an im tttution. In onter for Encray Reorunnlin inn Act of 1974. ns FOlt FURTIIER INfVRMATION CON- sur h n physicinn in continne in pin, tire nmended. nml sitt' ,ns f52 and T.53 of TACT: nucten r medictoc in n medir ni Inatttuhon Tide 5 of the tinti : d 8tntes Code, the Edwntd Podolrdt. Omco of Binndard, he will hnvc tn be nnmed on the In=titu-following nincndmr ;t to *Iltle 10. Chnp-Ikvolopmrnt, U S. Nucienr Itogulatory tinn'a lleense by the time his Individunt ter I. Cowie of l'cdel al Itcr.ulnllons, l'urt Cominission. Wnshhigtott. D.C. 20555, pholdnu ikchte noires At the exphn-
- 2. 15 publiehed an a document subject to phono 301-443-6010. tion of the individunt physician llecnec, j codinen tion. the Commission will not renew nuthor. -
- 1. Section 2 006 < f 10 CFIt Pnrt 2 is SUPPIIMENTAL INFORMATION: On 17ation for prnctice within n piedlent in-amentled by nridtog s new paragtnph (c) M9rch 3 1977, the Nucient Itegin!n- stitutinn Medient institutions thnt nl.
to rend na follow, tory Colomission (Nitri pubitsbed n pro- resuly hold on tm.titution Itcense nic cn-posed rule (42 Fit 12185) to nmrnd ILS 4 l 2.206 Itcquesta or scilon under this couinced to ndd the names of Individuni s u!>pa rt. regulntions in l 35.12 to limit the grnnt- physicians to their tristitution lleense Ing of Individunt physician liccuses to n immediately, rather thnu wntt untl! the physicinn or group of physicinns in pri- physicin n's Individunt lleense espireg een ill Directori deelstons under this vnte practice in nn omee outside of an mio pinposed tide chamnr. in ctfert. pro-sectton ullt be file i ulth the Ol!1ce of institution 'Ihe ofTect of this rule s'hnnke vides that lustitutinunt llectnes and indt. .; the Secretary. Witt in turnty t20) dnis is to require medlent institutions. now vidtyil physiclan lleenses are mutually nf ter t'ic date of i Director's decision operntlng nuc! car medicine procrnms exclusive. under this section that no proceeding under individual physician licenses, to Seven of the 15 letters reccised in re-u tll bc Irvtituted o' other nellon taken be licensed as institutions under i 35 !! sponse to the proposed rule were favor-in whole or in pnit, the Commission mny at the time of expirntion of the individunt able. Seven letters nhfecterl to the pin-on its own motion review that decisten, physician licenses obtained under i 3512. Imed rule in whole or in par t nral one in u hole or in pnrt to determine if the Under current NRC regulations. the letter discussed a point that was beyntut Dirce tor hns almsc< his discretion. This NitC issues licenses for haman ine of the scope of the propowel rule but will review power does ':ot limit in any any rndinnettve (byproduct) materint fll to be considercrt by the NRC for rule mnk-either the Commlui :n's supervtsory pou- rnedical Institutions. (2) to physicinns f or lug nction in the future er over dolcanted 3taff netinns or the prnrtice in ofilces outsidc of medlent in. Commission's lxmei to consult with the stltutions and (3) to some physic.lan.s DIscrsticN or Munn CoMMr Nis
- Stuff on a f ormal < r informal basis re- for practice within medical institutions. INDIVIDe AL \ S. INST!TUTION AL pa rdmg institullon )f proceedings under The current regulations are not clear as prsroNStRTUTY this section. to uhen it is approprinte for a ph>siciari
#25 No pettuon >r other request for pincticing at nn institution to hold the One commenter stnted thnt creatrr nc.
Coimhission regicw of n Dircrtor's dcct- llecnse and when the institution should countabdity is provided by individual 11-Flon tinder this seCU In s'lli De enlcrLajned hoId it. As a consequence. the physir tan censuics since the hernsee is tesponsible by the Commission alone holds the Itectne in some enws MM W t nd @ Mesn W 'Teru-urW r W W im p i p h and
.,' Eticctisc rinte 'I hl, nmendment be-comes eficettvc on .6urust 15. IM7.
I t I 11 e Ii { m ulnNous
""""I" He hu nut#"MntM
- HM Hu'
' In still others 890s. Itegulator y enforce- Y "#""""
esces set.186. pub . 83-7W1. 68 Stat. 948. ment problems might arise when both
- I* "
. eso, na amended e42 I' S c. 2201. 22itu. acen the hospital and the individual phas!- memMs nwung nt Mutu inWah 5' 2nl. as sunended. 206. Pub 1. 01 438 es stat. clan practicing thercln hold a heense *"I#""""" "
1242. 3249, pub ic 96-79, og stat 413 (42 or uhen several physicians practicing in I" ^ ratmn nnn "*"""' I"" h br u""c"t prow b M-U S C t,841. 5846) ) a hospital hold individual licenses. For duM hern% u mn UH- @w A W Dated at Washirgton.174 this 7th regulatory purposes. If u orkers or visitors "" day of July 1977. are oscrexposed to radiation. It may be efilftor . for med-difficult to pin-point primary responsi- tent institutk,n hcenses and indnidual For the Nuclear tegulatory Commis- bility for the improper practices Is the N" " #" " * " ston. licensed hospital or the lleensed physi- W ""# ' " *
- E sMcEL J. Cuttx. clan responsible? If two physicians hold e""w m#D!"*rWu%W@mh
; secrcfary of the Commission. licenses. is one physician responsible or ' ""
!. ? lrn poc.77-20ool rt ed 7-13-77.5.45 nml are b sth physicians reaponsible? Uns g i $ $#[c$h 7 Influro to estabtsh clear hnes of respon- licenser must appomt a medical isotopes sibility may result in the omission of nec- comndttre. The imhvidual physician 11-PART 35-HUMAN USEh OF BYPRODUf,T essar) safety procedures or the assertion ceire does not require appomtment og a
.y.- MATERIAL of confheting procedures-cither condi- m al o pn c n ce MW W 1
*;5 Specihc Ucenses to individual Physiciass tion may generate atoldable radiological practice tutmn. Institutional responsibihty in a private ofTice or in anis insti-as p and institutions hazards.
clearly focined under the institution 11-AGENCY: U.S. Nuclear Regulatory Com. T11s rule change is based on the con-ecpt that when nunoactive mnterial is cenw as the indtsidual phystrian respon-mission sibility under the physician license. He used on the premises of a medical insti-ACTION: Final rule tution, the institution and not the nu- num rM isninnes committee assists the physkt. ins nnd the institutinus mananc-BUMMAltY: The Nuctent Regulatory thortred physicians should hold the NRC nient tu structuring and admintstoting n Commission is ninending itA regulntions lleense. In the NHC institutionn! license saf e and eficctisc nuc! car medicine pro-to require most medical institutions to the individual physicians are designated gram Uds nuistance helps to assuie that be lleensed for the use of radioactive by name as the authorized users of by- N!tC reculations uill bc observed but does material in the institution, rather than product material in the Institution This not transfer ultimate responsibthly for the individunt physician using the radio, rule change will not affect medical insti- comohance u tth the regulattens f rom the
. active material Problems of administer, tutions (or physicians designated as in- lintitution to the medical isotopes com-ing multtple lleentes at the same institu- dividual users in medical institutinnst mittee.
tion created the need for the rule change that already hold an NHC lleense. The intended effect of the action is to Neither would the proposed change ntfect MoRE COMMENTS ON MFDicAL IsoTorEs
~t
- require medicalinstitutions to be respon- physicians who hold NftC licenses for C0" "'* E I
'3
- sible for the protection of all staff, pa- practice in their ofnces outside of medical Tuo comments uric roccived conertn-tients, and members of the public who institutions. Ing the eff ect on smnller- or intermedl-
'4 FEDERAL tlGl5 Tit, VOL; 42, NO 13 5-THUt5D AY, JULY 14,1977
9
-Q: .
RULES AND REGULAWONS i ' W" ' 36241 j ste-size institutions of requiring a medi- use byproduct material in institutions physician and medical sta!! to institu-cal isotopes committee under the insti- not hcensed by NRC, provided they bring tional administration as proposed * * * ' ! tutional NRC license. One comment sug- the radioactive material utth them and is detrimental to progress and service in . i gested that committees from large insti- remove it uhen they depart. The insti- nuclear medicine. 'Ite proposed change i tutions could act as the committee for tution would not be allowed to receive, will encourage and stimulate institu-I smaller institutions or function as an ac- possess or store byproduct material other tional chauvinism and inhibit inter-I tive consultant to the local committee. than the amount of material remaining institutional cooperation and sharing of l The other comment suggested that the in the patient. One commenter asked if services."In strongly protesting the rule i medical isotopes cammittees in small the proposed exception included the 11- change, another commenter stated that , hospitals would function as a committee censing of mobile nuclear medicine labo- there is ample justification for retention I in name only, thereby jeopardizing the ratories and suggested that it should not. of the present system in order to allow j hospital's position in the event an in- The same commenter suggested that the flexibility and avoid a monopoly of nu. spection is made. exposure to the physician during trans- clear medicine practice created by the The Commission is aware of the appar- port and the increased potential for mis- internal pohtics in small hospitals. An-ent burden on smaller institutions of the hsp make the receipt and storage of other commenter expressed the belief following wording in 135 lisbs regard. material on the premises of an institu- that clarifying language is necessary to ' ing the appointment of a medicalisotopes tion preferable to transportation by the insure that the internal polictes of in-committee ** Membership of the commit- physician. Another commenter suggested stitutions do not necessarily exclude
. tee should include physicians expert in that under the wording of the proposed qualtfled physicians from practicing nu-Internal medicine, hemotology, thera, exception, the physician would be re- clear medicine. Still another commenter peutic radiology, and a person expert. quired to take the patient with him when stated. " Requiring of licensing of users enced in assay of radioisotopes and pro, he c.eparts, or at least collect and re- under an institution is comparable to tection against lonizing radiations;" move the patient's contaminated excreta, licensing physicians u" der an institution t emphasts added) . The use of "r.hould" in rather than permitting the patient to (hospital) to practice medicine instead use the sanitary facilltles available in of providing state licensure. This is an the regulation connotes a strong recom.
mendation. Ilow ever, in the case of the hospital. unnecessary encroachment on the prac-The exception to authorize individu- tice of medicine." Finally, one com-smaller- or intermediate-size institutions ally NRC licensed physicians to bring menter stated the concern that a physt-with limited nuclear medicine programs nuclear medicine services to institutions clan licensed in one hospital might be the me'nbership of such a committee and clinics is intended, where approprl- prevented from practicing or consulting might properly be composed of a physt-clan trained in nuclear medicine, a per- ate, to include the services provided by in another, perhaps less expertenced, son trained in radiation saiety and a rep. mobile nuclear medicine laboratories. hospital. resentative of the institution's manage-For license approval i 30.33ta) t2) re- The NRC license is not a license to ment. quires that the applicant's proposed practice medicme. The physician must be equlpment and fac111tles be adequate to heensed by the State to practice medi-The Commission does not accept the protect health and minimize danger to cine, prior to receivmg an NRC !! cense. suggestion that medical tsotopes commit . life and property. The authorization for The NRS license has quite a different tees may function in name only in small private practice in an institution v.ill be purpose- -assuring the safe handlmg and hospitals. All NRC institutional licensees granted only if the physician demon- use of radioisotopes. To the extent that are expected to have functioning medical strates in his license application that he it affects the practice of medicine,it does - isotopes committees
'Ihe Commission la considering alter- bothwill take adequate measures to provide so no more than is necessary to protect i for his own safety and the safety radiological health and safety.
natives to the present medical isotopes of the public while he is using radio- Contrary to the suggestion contained committee such e.s a radiation safety active materials within the institution in the comments, the Commission be-committee with a simplifted, contem- and while he is transporting radioactive 11 eves that the use of institutional 11-porary membership scheme that would materials to and from the institution. censes should promote flexibility and in-be responsible for coordinating the use For transporting radioactive materials statutional cooperation. Under the NRC of byproduct material and monitoring these measures will include adequate institution hcense, the individual physt-the institution's radiation safety pro- shielding and provisions to prevent spills clans practicing nuclear medicine in the gram. The Commission is not presently such as the use of absorbent material institution are named in the hcense ap-and vials with septum seals for inject- pilcation. The addition of another physi-ty m e from I g i ables. tian to an institutional license would tions acting for smaller institutions. Al- The language of the proposed rule ordinardy be routine. Morover a standard though voluntary joint rnedical tsotopes does not prohibit the common practice license condition of the institutional 11-committees have worked well in metro- of all wing the patient to excrete radio- cense is that a physician may use radio-politan areas, the Commission feels that active material Wto the sanitary sewer active material under the supervision of such a requirement might jeopardize the system of a hospital. Excreta from in- a physician named in the institution'a autonomy of the smaller institutions. dividuals undergoing medical d!agnosis license. This license condition is primar-CALIBRArloN SOURCES , or therapy with radioactive material are fly intended to permit the training of exempt frorn the 1 20.303 limitations on physicians under an institution license One commenter suggested that cali- discharge of NRC licensed material into but certainly would cover a visiting bration sources be added to the list of a sanitary sewerage system. It is not physician not named in the institution's permisslble uses of byproduct materialin necessary to change the wording of I 35.- license as well. In the absence of an in-i 35.12tb)(1). This comment is helpful
- 12(b)(2) to permit a practice that is stltutional license, a physician seeking to A new I 35.12(b)(2)(lv) has been added not prohibited by the rule. use licensed materials at a new location Under this exception, the NRC will must apply for an entirely new individ-con 1 checks of o ive assay hold the phyaletan responsible for all ual license or an amendment to his ex- i strumentation, radiation safety instru-activities conducted under his license isting 11 cense; in either case this is likely
" '" both inside and outside the institution. to require a thorough NRC review of l on n the list o p rm ble of *D produ:t material under the exception for INar!TtrrioNat. AUrnoarry y e111tfe at e ne oc"a on individually licensed physicians practic- Five commenters objected to the pro. In the f!nal analysis, it is important ing in small hospitals. posal for NRC to license institutions to the Commission from a regulatory THE Exczprion rather than the physicians practicing standpoint that the institution contro! '
therein, because this action would be an and be responsible for who uses licensed There were three adverse comments undcomd intruMon of W Inautuuons' matertal Wn the Inamuuon, h M i concerning the proposed exception for management into the practice of med!- is not and cannot be a guarantor against ' small hospitala in i 3312%) that would rine Arronting to one commenter,"The nrhttrnry staff practices within a medical {
, al;ow individually licensed physicians to shift of de fut to clinical authority from institution. I
{ PsDfsAt stGilits, VOL. 42 HO.135--THUslOAY, JULY 14,1977
---,m- ,--_c,..~.- ..._,_-,___,,,m__ ,,_,__.,m
M212 ' RdLIS AND RIOULAHONS CouurmT llavemn fWrs 8 2' 'Ilin phyatrin n 1.' 19p= lhe hv orent-One commeriter suggested thnt the ud tuntnial wlut hini unil temoven the !ven Cutumtly, t%hiccih.g and Manu. proged l 3512stil(4I he expulided to hyprinsliart innterial v hen he departs. incturinN Itec ton, 9010 le., lir uirli FAA Northw cal
', ,l Murpinal Way ine' tide certinration by (lie Arne&nn I" "U"Uf"h""i mehe.Im m Hou% &n t Hr. ' Va shlig ton 08108.
Oste.opathic Donrd of Nuclear Mcc'. cine or stone byproduct umtrrin! other than telephone 1200) 70 '-2516. or the American Onteopnthic College of niotmt of materlat remaining in the Radiology. with profielency in Nuclenr 8t!PI'!JM MNTAltY IN!"Olt M ATION : Medicine, as being antinfactory to com- (35 The medical institution d0" dot 't he manuf acturer :ns revied Boeing olete the NRC training requirements _ hold byproduct material licenso under 8ervice Bulletin No. i3A-2131 to provide This suggestion is beyond the scope of - - rewmk prern wh h m3
. 'the notice of proposed rulemaking.The (Sec.161. Pub plish*d. constitute errnir.ating action NRC staff is currently studying the pos- U.e c 22011: sec 1. 83-70 r. 68 stat 948 442 under the provision 9 )f this AD*
208. Pub.1,. 93-438, 88 Stat, sib;11ty of routinely accepting certifica. 1242 842 UJe c. sats ti DurttNo Ir ronMarioN tion by certain medical banrds am anun" factory evidence of adcqunte training for day Dated nt Wash!ngton, D.C. this 7th The principal nut sorn of this doru-
.. the human use of byproduct material. of July 1977. rnen t are Iven Connn ly, Engineering and f- Under the Atomic Energy Act of 1954. For the Nuclear Regulatory Commis- Manuf acturing Drari h. FAA Northwest -'f as amended, the Energy Reorganization alon. Region. and Jonath in llowe, Regional Act of 1974, as amended, and sectiong BAM t'El. J. CHILK, Counsel. FAA North' . cat Region.
552 nnd 553 of Title 5 of the United 8tntra Secrrforp of the Commission- gggggggg,ampggn cng gt rc!lrvfng and Code, the following amendments to Title imposes no addittor- al burden on any
- 10. Chapter I. Code of Federal Regula- IPn Doc.77-20004 P: led 7-13-77.8:45 ami person. notice and public procedure tions. Part 35 are published as a docu- hereoh are unnecessr ry and the amend-
. ment subject to codification- Title 14---Aerona itics and Space ment may be made 'ffective upon pub-Bection 3512 is revised to read as fo]. CHAPTER l-FEDERA AVIATION ADMIN. lleation in the Frorp it. RecIstra*
' lows:
ISTRATION DEPAN TMENT OF TRANS. ADocTroN or n r AMENDMrNT
$ '3S.12 Specific licenace so indirid..al PORTATION Accordingly, rursu int to the authority phy.iciano for human une of by. lD cket No.14682 Amdt No II-14l delegnted to me by the Administrator, product material. PART 11--GENER. L RULEMAKING I 39.13 of the Feders 1 Aviation Regula-ta) An application by an individual PROCEE URES tions (14 CFR 39.1 h is amended by physiclan or groups of phystelans for a ' Procedural Requireme its for Petitions for "*'" ^
speelfic license for hurnan use of by- Exemp .ons Ad te 110 k g~ a g ph-* product materi.d will be approval if: P. Remork in acco dance with Boetng (In The appheant satisfles the general C FTf( 4 requirements speelfled in i 30.33 of this 8 mice Bulletin No 534 2131. Restston 2 or In FR Doc. 77-1928 i appearing at page later FAA approsed ret 4onn. or in a manner cha pter'. 34864 in the issue to ' Thursday. July 7, approved by the ch f. Engineering and (2) The application is for use in the 1977 in i 11.2Bbi tl) on page 34865, in neanuf actu d ng Bram 1. FAA Northwest applicant's pracuee in an of5cets) out, the first ime the word " petitioner" should gion n u' " ating action under alde a medicalinstitution; have read petition $.,niep, manuf
, of th acturer's i
s-
- 43) The applicant has access to a hos- ,ectftcations and pro-pital possessing adequate facilities to hos* cedures identified and sescribed in thte di-pitall2e and monitor the applicant's l Docket No. 77-NW AD; Amdt 39-2963] rective are incorporatad herein and made a part hereof pursuant to Us c 552(altli.
radioactive patients whenever it is ad. PART 39-AIRWORTH NESS DIRECTIVES Au personn arfected ry this directtre who d ts bl d have n t already recelled these documents % v4) e soplicant has extensive expe- anM & m the manufach may obtain copies
- rience in the proposed use. the handhng AOENCY: Federal Av $ '" ' p ne .
and administration of radioisotopes, and tion (FAA), DOT. ation Administra- $m"p P O Box 3 O e ^h (n 98124. These documen s may also oc ex-where apphenble. the clinical manage- ACTION: Final rule. amined at FAA Northwir t Region. 9olo East ment of radioactive ratients. tThe phy- ntarginal Way South. seattle. Wa.shington sicia nis t shall furnish suitable eviden'e e SUhthf ARY: In Af arel 1976. an airplane 98108 of such experience with the aprlication. 8,uffered a mild decon pression due to a A statement from tha medical isotope #5-inch crack in a 1 aselace lap joint. This amendment becomes efective committee in the institution where the Amendment 39-2538 AD 76-05-05 was July 21* 1977*
*- appincant acquired experience, indient. issued requiring inspet tion and repair of (Sees. 313 r a), 60I, and tn3. Federai .nlation
.l ing its amount and nature, may be sub. certain fuselage skin 1 ip joints. Amend. Art of 1958. as amendec (49 U S c.1354:n).
. mitted as evidence of such experience ) ment 39-2698 further amended the AD 2 and 4 i f th
,% tb) The Commission will not approve to provide repetitive to spection intervals. ,, ,n t cf 'b"n b ct a an application by an individual phys 1 The ADis now being a nended to provide 1655 t al ): and to cFn i 89 )
clan or group of physicians for a specific terminating acUon. Norr -The Federal A , tation Administra-e' license to recetve. possess or use byprod- tion has determined tha1 this document does X. . uct material on the premises of a medi- DATES: Effective July 21.1977. not contain a major prei mi requirine prep. , cal institution unless: ADDRESSES: FAA r orthwest Region, aration of an Economic Impact Statement gli The use of byproduct material la Engineering knd hiant; f acturir.g Branch, Executive under Executtte Order 1 821, as amended by ; limited to: 9010 E. hfarginal Wa r South, Seattre, A- t o7. Order 11949, and OMB circular d (1) The administration of radiophar. Washington 98108. ,
' mateuticals for diagnostic or therapeu- Boeing service bull ' tins specified in Issued in Seattle
- Washington on #
tic purposes; this directive may b ' obtained upon July 1* 197**
- e li t The performance of diagnostic request to Boeing Cori mercial Airplane J. H. TANNER.
i studies on patients to whom a radiophar. Company, P.O. Box 371 7. Seattle, Wash. Ai ting Director, I M maceutical has been administered; ington 98124. These do 'uments may also N(rihtcesf Region.
?
- tilD The perfonnance of in vitro diag- be examined at FAA ? orthwest Region, n4 ,nostic studies: or (The incorporation ]y reference pro- !
tivi The calibration and quality con- 9010 East Efarginal W, .y South Seattle, visions in the documeit were approved F 4, trol checks of radioactive assay instru- Washington 98108. by the Director of the Federal Register mentation. radiation safety instrumen. FOR FURTHER INFO ufATION CON- on 'yune 19,196D ;
. tJition, and diagnosuc instrumentadon: TACT: ,. . [FR Doc.77-19849 Filed 7-13-77;8:45 aml 4 r.,
- F J
. j F{ DER AL REGlifER, VOL. 42, NO.135-THutSDAY, JULY 14, 1977 t
1
RULES AND REGULATIONS , 33891 panied by pown unit. carrte viu ne mon (s) If omrrie cle arrives prior to 4:3 p,c,,iew., ente withou ,,,- m traum untu such ome . ithasF - ved emoduied ume. .sman nb begm to mn f,om gnits sp0!!!np or ,r , r&O Oy,,t power nohun punuant m esction 3. mat h no a @ M ed u m W N1 h eq piore nta item applies when carrier's trailer is ready for pli kup. Conalgnor, con. commences, whiebevor in earlier, ) vehicle 4,without power units are delayed or signee, or other desigtsted party may ablft Keetton ( Charges. ( ) General detention detained on the premises.cf consignor, con- the spotted trailer with its own power units charges: After the esp uon of free Mme as signee, or on other premlaes designated by at its own expense and risk for the purpose provnded for detalningin secuon Sta ofv1D a trail thisbeitem, charges assessed as them. or as close thereto as conditions will cf Section loading J:or Computation unloadirg. of free time. (a) follows: rmit, subject to the fcglowing provisions: 04styr Bec.1. General prot 4stons. (a) Subject to Commencement of sp>tting and free24 time: (1) 8 potted trailers will be allowed con- (1) For each of the flict and geoond the availabutty of equipment, carrier wul secutive hours of free time for laaMy or un. 34-hour periods or fraction thereof spot empty or loaded trauers for loading or loading. Por trauers spotted for unloading. (Saturdays. Sundays; and hrmays unloading on the premises of oonsigner, con. such time shall commence at the Mme of excepted) .........J............. 338 signee, or on otber premises designated by placement of the traue r at the site designated (2) Por each of the tigrd and fourth them. or as close theretog as conditions wul by oonsignee, or otheP party designated by $4-hour periods or 100 thereof gg consignee. For trailern spotted for loading. , (Saturdays. Sunda and houdays (b) hading or unloeding will be pet. such ume shall commence when the trauer excepted) ......... .............. 36 formed by constgnor, cpnsignee, or other is spotted at the site specificauy designated (3) For the fifth and each succeeding party designated by them. When carrier's by the consignor or a party designated by 34-hour period or fraction thereof employee assists la loaqing. unloading, or consignor, or, in the onse of an empty trailer (Baturdays, Sundays, and houdays checking the freight, tdr with detention powerprovt. units ptsced at the premiset of consignor without incJuded) . . . . . . . . . < .............. 80 stons governing vehicles spec c mques a th wul apply. In the case ofupotti,ng for loading (b) Delay in tra!!an pickup canarge: No d 1 additional charge w111 be made for pick.ing the Bill of Lading must ibow Shipper Lead Up n the expiration cf W 24 Mun of free up tallers spotted u:ider this item wthen and Count time. detention chargps w1D accrue as pro. such pickup can be performed within 80 (c) Carrier responstbu:ty for safeguarding Nded m Sectun 4 shipments loaded into tri,Uers spotted under (2) When any porum M the 24 hou? M minutes after arrival of driver and power unit at premises of coasignor. canstgnee, or tre provisions cf this ite n shall begin when me en ends into a Saturday. Bunday, or other party designste$ by them. When a loading has been compl<ted and possessi oliday (national. 8ts% or municipal), the delay of more than Sti minutec is encoun. thereof is taten by the currier. corrputation of time for such portion shall tered. detenuon charles for vehicles pith (d) Carrier responsibility for safeguard- resume at 12:01 am. nn the next day which ing ab1pmer,ts unloaded from tratters spotted la nettber a Saturday. Bunday, or holiday _ pown wul commnce rom W ume of arrivat under the provisions cf this item shau as spec 1 Sed m item L cesse when the trailer ni spotted at or on day. (3 Free time aban not begin on a Satur. (c) Strike interfemico charge When be. the site dealgnated by cor signee. Sunday, or holiday (national. State, or cam M a Me M H6 empMyses, M As im-municipal), but at 8 a m. on the next day possible for consignos, consignee or cther (e) Free time for earld vehicle wiu be as which is neither a SatIrday, Sunday, or bo11 pany designated by ttom to make sullable provsded in section 3 After the expiration day for monum by carnar any parcaUy loaded, of free time charges win be assessed as pro. (4 When a trauer is both unloaded and or empty trailers detatied on their promises. vided in section 4. reloaded. eneb transaction wiu be treated e M p ay oe fraction (f) De detention chsJ ges due the Carr'.er Independently of the Cther, except that when hoof, pc traun WL1 be made fonowing will be assessed against tpe consignor in the loading is begun before unloading is com- espirsuon of im h Saturdays. Sundays. case of spotting for lopding and aga!nst pleted, free time for 1)ading aball not begin and houdays abau k neluded aftw h 4th the consignee in the ca me of spotting for until free time for unjoading has elasped. y M charges. m unloading trrespective cI whether charges (b) Tvrminauon of spotung and notines. 8'geetton 5. Jteco*ds. J written record of the are prepaid or co!!ect. (g) Nothing in this 11rm aball require a tion: (1) Consignor, consignee. or other party following information 1nust be enntntained by designated by them stall notify carrier when W cardu on &H Wied trauers, and such carrier to pick up or deliver spotted trailers loadtng or unloading has been completed record must be kept avallable at all umes: at hours other than cariner's normal hours. and the trailer la avellable foe pickup. The (a) Name and addreis of consignor, con-his shall not be cons' rued as a restric- trailer will be deemed to be spotted and signw. w othe pany 6t whose prunness h j uon on carrter's abutty tther than its nor- as W car-'in recetus not1Scauom Nouaca- , mal bustnus bom tion by telephone if convenient and practical, (b) Identificadon od erotted trauer;
- gection 2. Deftstrions. The following gen. etherwise by telegrapt or man aball be given (c) Date and ume cf armal of h trauw fw ePotung; oral definitions will app y when the below by consignor, consignee, or other party desig, terms am used in his 1 em: noted by them at the r own expense. to car. (d) Date and time notlacation that the (a) " Vehicle means t acter-trauer corn- rier or other party deitgnated by carrier for spotted trsDu la nad y for pickup was re-binations used for the transportation of the purpose of advistrig such carrier or other cetted by carrier; property where: (1) "D kiler means mobile party that the spotted trailer has been loaded (el Date and time o ' arrival and depaMure units with or without wt atts, used to trans- or unloaded and is reddy for pickup. If nott- of power unit for plek1 p; poM proputy an,d, fication la by telephonie, carrier may require (f) 'Ittal actual wel gtt of ablpment when (2) "I'rmetor* Enean . a mechanically written conSrmation' pickup is delayed in es ses of 30 minutes-un used I w draw a tran" (2) When a spotted trauer la changed to a (g) De durataon <f any strike induced' b cle with pown aL the raluest of con- delay on the promises < r consignor, consignee.
(D) "rmaMng" includ n: (1) Furnishing - or othe designated p ity which resulted in foi earding directions- by them. W fm time and detenton charges carrier's inability to ot Lain the release of any of the Bul of lading'nse or other documenta asary for forward- " ' "
"I ing the shtpment to tbd carrier, and i e equested and made *
(2) Notification to 12 e carrier that the before the expiration of free time for a (b) Whether trmUes 6 are spotted under a vehicle is loaded and reed v for forwarding spotted trailer, free Mme w1H eense Im- Manged achedule, (c) " Unloading" inclu les: (1) Surrender mediately at the timt the request is made. (l) When trailere ad p spotted undw a pre-of the Bill of lading to be carrier on ahtp* and detention charges for vehicles with power menta buted "'!b OrderJ win immediately comnonce with no furthw arrsagsd schedule, tb date and time spect-(2) Payment of lawi al charges to the free time allowed. Sed therefor. earrier when required ] rior to delivery of (til If the change e requested and made Nors: Por the pur1 ones of this item the the ahtoment. after the erptration cd free une for a spotted terms spotung and di opping are conesdered (3) Nottftcation to the carrier that vehicle tratter. free time and detention charges will to be synonymous and are used interchange-to unloaded and ready 1 Dr forwarding, and be computed on the bhats of a spotted traller ably. (*1 surntna of delivery recetpt. up to the uma the caange was requested in (d) "Premia=9" means the entire proputy addition thereto, the 1shicle will lamediately W DocM8931 P led 4482 aan] at or near the physical fa :111ttes of consignor. be charged detention 1or a webicle with power Donalgnee, or other dest ( Insted party- with no further free tlme allowet! IUaI (e) "ette" means a . poetae nocetien at (c) Prearranged seapdultng: (1) sub>ct to I-MUCLEAR RESULATORY or on the promtama of e insignor, consignes, the provtalons of tienP. and upon mable COMMISSION or other designated pa ty. requent of consignor comangnee or othere arrter win without ad. Reports 90 the CennistiSH Centernirtg I (f) Spotung" maam the placing of a designated by them, e OM andl Montsetpliance trailer at a spectSe alte eenignated by con- ditaonal charge ente r into a , :p } signor, consignee or ett rr party designated arbedule for the e Ttval of trauere for MEff% M NLiclear Regulatepry by them, detaching the trauer, and leaving spotting finmmlaminri
- the trailer in full poses eston of conalgnor, (3) If omrrler's set icle arrives later than 8 Eare the carrter to to identify its pertament eensignee, or other designated party unat- the scheduled ume, t tme shall begin to run tended by carrter's employee and mana==* frt*m actual time spotung anmwa rule.
i 1
RULES AND REQULATIENS 28892 , ameMedre that me hm%n has been tions frts licecacer and the Mhc an neequatelp taformed of such eefect or fau- memods of securitag hformanon coc-ACTION: Final rule. i
SUMMARY
- Le Nuclear Regulatory are to cerning the implementation effectiveness d.
(b)compir. Any person who knowingly ana con- of CommMon regulauons. His hfor- ' Commisalon is amending its agulauons e r a u ne mation is an essential ingredient of sound in to gwo sde to require directors and responsible om. gious Maum N ruulanons in Part 21 cers of Arms and organizations building. m m m operating or owning NRC licensed fa- to the amount provided try eseuon su of add another required natinnilan.M
- cilities, or conducting NRC-licensed me- the Atomnc Energy Act of leM. as amended. Over, a logsgstanding Cammt uviues. to report failures to comply with <ct ne requirements of this section aba!! encourages todividuals not amb)ect to the regulatory requirementa and defects in be prsminecur posted on the premises of Comminaion's regulations to re components which may result in a sub- any facmty hoensed or otherwtse reautated Commission k com a knownb or sus M SsaUmoriBd stantial safety hazard. Also covered un- PursuantEa to the atomic Energy Act of 1964. law, Mthe fa identity of anyone so reporting der the new regulations are directors qd commission h authortmed to con. win be withheld from disclosure.
and responsible omeers of Srms an duet such reasonable inspections and other 'Ihe Commiazion intends to examine Organizations supplying safety-related enforcement actietttes as needed to insure components, including safety-related comphance with the prortstons of this21 soc- withclosely a view the implementauon to making of new P any clarifying design, testing. Inspection and consulting uen." or other changes mat =sy be warranted
'Ihe new Part 21 requires that the dj, in light of experience. In particular, in-NRC licensees and other nrms and rectors and responsible omeers of orga. sumclent experience has been accumu-organizations covered by the new regula- nizations mat construct, own, operate w lated M permit the writing of a detailed tions must adopt internal procedures to su ply com ents of a facility or activ, regulation at this time that would pro-assure that s&fety related defects and Ity that is censed or otherwise regu, vide a precise correlation of aU factors noncompliance are brought to the atten- lated by the Nuclear Regulatory Com, pertinent to the question of what is a alg-tion of responsible omeets and directors mission inform the Cnmmi"lon if they niBeant safety hazard. Part 21 is in-hose individuals. in turn, wiu be re- obtain information reasonably indicat- tended in this ngard as an initial efort quired to notify the Commission within ing that such facility activity or basic to identify a number of the factors in-two days, and file a written report within component falls to coInply with regula- volved with the question of signif5 cant Sve days. of learning of the defect or tory nquirements relaung to substanud safety hazard. Purther, additional guld-noncompliince. Directors and responsi- safety hazards or that such facihty'de- ac- ance in W form M ngulaton suMes ble omcers may designate an employee to tivity, or basic component contains s may be developed should experience with provide on their behalf the not1Scation fect which could create a substantial the application of Part 21 indicate the 2 NE. safety hazard. Part 21 additionauy re- need for such guidance. In this Ngard.
EFFEC *ITVE DATE: July 6.1977. Certain qui.es that these organizations establish we expect a im emen a on ef-and obligauons under the e!!ective rule are procedures not imposed untu January 6,1978. the technical to evaluate deviations requirements of the from pro- ha y gg rs' of h pubhe, abouM pmW h r e rn e evisti n in ord necessary data base, & such furmer TAE that the purchaser evaluste the devia- guidance Mr. W. E. Campbell. Jr. OEce of tion or have it evaluated. The organiza- During the development of the Energy 1 Standards Development. U.S. Nuclear tions subject to the regulations in Part Reomannah Act Conguas M,enh Regulatory Commission. Washington. 21 may be many procurement Uers away u from the holder of a license to construct ",,"* te D.C. 20555. Phone 301-443-6911. or operate a nuclear power reactor. If 206 was developed to $11 that need. SUPPLEMENTARY INFORMATION: the beense is other than to construct or IntenstM persons have hen aEardd On March 3,1975, the Nuclear Regula- operate a nuclear power nacts, then an opportunity to participate in the de-tory Commission published in the Pro, the organizations subject to the reguia- velopment of Part 21 and the associated saAL RectsTra (40 PR 8832) for pubhc tions are those organizations that di- amendments. The m ore important comment proposed amendments to 10 netly supply me licensee of h faciuty changes made to Part 21 are listed below CPR Parts 2,31. 35, and 40 of its regula- or activity. The directors and responsi- and are based largely on consideration tions and a proposed new Part 21 to its W omeers of mese organtamuons wm be anmments. regulations. "Re., porting of Defects and subject to a fine of up to 45.000 for each of g33 puhuc.he
.g udvMuals suWt b 2e no-Noncompliance. deliberate failure to notify the Commis- ti$cauon requirement of Part 21 have he purpose of these proposed amend- sion of the existence of such a defect or bun retM M (a) dinctws and @
ments and the new proposed Part 21 is to noncompliance. %e organimations sub- otheers vested with executive authority implement section 206 of Pub I. 93-438, ject to Part 21 regulations must also over activities subject to this part. These
'the Energy Reorganization Act of 1974. maintain neords, post copies of spec 1Sc individuals may identify an individual as amended. docurnents, inform procurement subtier that is authorised to provide notineatian Bection 206 of the Energy Reorganiza- suppliers of their msponsibility under to the Cammianton.
tion Act of 1974 as amended, reads as Part 21 and allow inspection of their his new part is only one of mad of gogo g premises, facilities and activities by duly the reporting channels that concerne de-
-Nowcontacu ~ fects or noncomphance, es 10 CPR see. see (a) Any snatetdual director, or slo - 80.55(e). Indfriduals that are subject to responsible omeer of a arm const.ructing. 'I'he Cammtazion neuires that a num- the requinments of this part that be-owning. opersuna. or supplying the compo. ber of reports and notincations be sub- come aware of a defect or noccomphance nents of any recutty or acurtty which is ts, mitted by licensees. These include licen- that is outside the responsibility of their censed or otherwtee regulated pursuant to see's report of incidenta required by 10 organimation and individuals that are the Atomne Energy Act of 39M, as amended.
er pursuant so tbss Act. who obtains infor. CFR I 20.403, permit holder's notifica- t sub ect 2 me to of
' un f design or construccon deficien- part of Tiue 10 are encouraged, but ru or Ityor e coup entss by 10 CPR I 6035(e)(1), required, to report to the Cammismiari pued to such reculty or mettetty- cies mouind,s Noort of theft or at- known or susp0 Clad defects or fai!Ure to and licensee (1) Phus to comply with the Atomic En. tempted theft of special nuclear malerial 00:5p17. As au@ortsed by law, Se iden-orgy Act or leM. as amended, or any app!s.
emble rule, regulauon, order. or 12eense or required by 10 CFR I 7032. Other Coni- uty of anyone so mporting wm he w!2-the na--non rezaung to sumstanual mission regulauona provide for reesipt of held from deada=mes various kinds of requests or infonnauon. earety hasares,er (2) Part 21, as adopted, does not spect-I (U contains a eefect which could create For *wampI* 10 CFR I 2J02 provides for fy whether Arms stay sottr.buree di- - a substanual strety hasard as de$ned Dy peutions to issue, amend or macind reg, rectors or paur==^1* oScors for civil regulauens watch sne nn==waton abatt ulaucus, and 10 CFR I 19.16 provides for promulgate. anau ammediately notary me not18 cations freen workers in Ngard to penalties imposed pursuant to these Mg-co== won or such rauure to comply. or or such errect, unless such pereen has actual radiological hasards These counmunica- ulations, and tastead allows essesAt mess 7ss, vot. 43, eso tes-.asossaY, JUNE 4, Ifry
/ . RULES AND RE2ULATIONS 28893 - to be resolved in accordance with appil- construction Major deficiencies involvior design, components or services: 1.e.. procured on l inspection, test or use of .or after six months after the effective j I cable state law.' date of Part 21. ~ (3) The definition of " defect." as ap- licensed facilities or material. The effecuve date of 121.6 dealing plied to componenta themselves. has been To the extent that failures to comply testricted to include those deviations in or defects in a security system can con- with posting requirements, t 21.21(a) de!!vered components from technical re- suchtribute to a and failures substantial defectssafety hazard, are within the dealing i 21.51 dealingwith adopting pro dures, and with maintenance of quirements included in the procurement records has been deferred until Janu-document that could, on the basis of an scope of Part 21. (6) Clarification has been added in ary 6.1978, to allow organizations to evaluation create a substantial safety regard to which organizations are subject establish and implement procedures. hazard. Defect also includes a deviation to the regulations in this part. In order (9) The organizations subject to the In a portion of the facihty subject to the mat the implementation of Section 206 regulations in Part 21 are required to I construction permit or manufacturing may be responsive to anticipation of prepare records in connecuon with their licensing requirement of Part 50 provid. l'rotiems before the event, a broad in- activities to assure compliance with this ed the deviation could, on the basis of an evaluation, create a substantial safety terpretation of " firm constructing own- part. Prior to destruction of such records hazard and the portion of the facility ing. operating nents" or supplying has been the used. This compo- theyIt shall interpretation is notbe offered tothat anticipated thethese purchaser. docu-conta!ning the deviation has been of- Includes not only licensees and organi- mentation requirements will necess. tate fered to the purchaser for acceptance. rations that physically construct facill- any change in the documentation pro-Whether such deviation could result in ties and physically supply components cedures of orgututions that are pres-a substantial safety hazard is determined tut also includes organizations that only ently complying with 10 CFR 50 Appendix during the deviation evaluation. Defect supply safety-related services such as de- B. Quality Assurance Criteria" also includes, for facilities beensed for sign. inspection, testing or consultation: (10) Clarification has been added in operation under Part 50 any condition e.g., site geological investigations. regard to the apphcability of Part 21 to or circumstance involvin'g a basic com- This interpretation is intended to the licensed activity of exporting. Per-sons who are only licensed to export ponent ceedingthat of acould safetycontribute to the limit as set forthex-in tring thosewithin theorganizadons various regulations in that this can part nuclear facihties or materials and who the operating hcense technical specifica- create a substantial safety hatard con- do not otherwise construct or operate Uons' sidering the various methods available facilities ornot activities subjectortosupply compo-(4) The definition of basic components for consulta". ton, procurement design. nents are the new part. has been divided into two parts: one part construction, testing, inspection and op. Individuals subject to this part need re-is appucable to power reactors beensed eration. These methods include not only port only defects or failures to comply which could create a substantial safety under Part 50 and the second part is the cption where design and construc- hazard in facihties and activities within applicable to activities licensed pursuant tion are accomplished by one organiza- the United States. Further, any notifi-to Parts 30, 40, 70 or 71 and to other tion tut also the option where one or-cation submitted in accordance with Part 50 fsciuties. Por power reactors the g1nization does safety-related consulta- Part 21 may be exempt from public dis-definition is based on the guidance given tion, another safety-related design and in Regulatory Guide 1.29. For other fa- another the actual construction Each of closure as authorized by law. After consideration of the comments c111ttes and settvities, basic compnnent these organizations has the capabihty to received and other factors, the Commix-has been defined as components that are generate a defect and a potential for f ail- sion has adopted the amendments to directly procured b: a licensee. ing to comply. Parts 2. 31. 34. 35, 40, and 70, and the (5) Substantial safety hazard has been If a basic componer.t is fabricated by new Part 21 set forth below. defined in terms of a major reduction in one organization using a design from an-the degree of protection provided to the other organization, the possibility of Pursuant to the Atomic Energy Act of pubhc health and safety. Criteria that creating a substantial safety hazard. 1954, as amended, the Energy Reorgant-are appropriate for determination of based upon a faulty design, exists upon sation Act of 1974, as amended, and sec. creation of a substantial safety hazard the delivery of the design that fails to tions 552 and 553 of title 5 of the d include: comply or contains a defect. A substan- States Code, the foHowing new f al Moderate exposure to, or release of. D- tial safety hazard. based upon faulty Title 10. Chapter 1 of the Code of fabrication, exists upon delivery of the Regulations, and amendments to Parts censed material. item that fails to comply or contains a 2,31,34,35. 40, and 7G are published as a Major degradation of essential safety- defect. In many instances the cordpetent document subject to codification.to be related equipment. fabricating organizauon possesses effective on July 6.1977. I 8While agreeing with all other aspects of sitt11ty for design. PART 2-4 TULES OF PftACTICE this Nouce. commissioner otunsry believes Paragraph (b) of 12.200 is amended to t n ce pons b o r Yo 8[ of es cons tad ere y a stage of conceptual design or consulta- read as fonows: ues that imposed secuon 306 punuant to Partneorganiza. of the Energy 21. on grounds tion in regard to feasibility. Only when $ 2.200 Scope of subpart. tion Act is designed to impose penonal re- such a design or Consultation can result , , , , , sponsibility, a goat undermined by corporate in the creation of a substantia! safety (b) ' Itis subpart also prescribes the indernntacation. 'Ite commtaston majority hazard is it appropriate to specify the procedures in cases inluated by the staff betteves that,in accordance with the generat appucability of Part 21 in the procure- to impose civil penalues pursuant to sec-
- pracuee of federal regulatory bodies in anal. ment document. tion 234 of the Act and section 206 of the ogous matters. the quesuon of the reimbun- (7) The organisations subject to this Energy Reorganisauon Act of 1974.
" part must estabush procedures to pro-a 1 cane tate law It not tha $ a'd vide for correction of dev1stions, or 2. A new Part 21 la added to read as verse pubtletty attendant on being sub}eeted evaluation of deviations or informing follows:
to a civu penalty for anowingly conceanns signineant safety informauen would be a purchasers of the deviation so the pur- PART 21-4tEPOR71NG OF DEFECTS AND major tacentive to compliance trrespective chaser may evaluate the deviation, p g gg of whether the person so pena:tred was later These stocedures must also provide for Osnaat. paomosrs eelmbursed by the ecmpany. 'Ibe maiority informing a responsible of!1cer or direc-atso recognizes the settous practical dimculty tor of the organisation of any ruulting Sec. In atteenpung to SHferenuate between a defect or failure to Comply
- 31.1 Purpose property awarded salary increase or bonus @ The provisions of Part 21 impos- 3 and an improper reimbursement if Part 21 g), og,
% does not in practice appear to be accompitah. ing requirements that procurement 31 4 Interpretathons. y Ing sta purpose. the commission will. of documents state, when applicable, that 31.5 communicauona. coune. propose changes deemed appropriate Part 21 applies would be appucable only si e Posung requirements. in light of espertence to future procurements of facilities. 31.'r Exempuona. PEDEtat 99G15TI8. VOL 42, 900. ISS-JAONr)Av. JUNE 6,19yy
~~
l i 1 28894 RULES AND RESULATIONS Normcarsoor 40,50,70 or 71. Nothing in these regu- as defined in paragraph (d)(1) of this lations should be deemed to preclude an section; or sist Nottacauon et tattun to comptr e, Individual not subject to the regulations (3) A deviation in a portion of a fa-esistence of a detect. in this part from reporting to the Com- cility subject to the construction permit i y mission a known or suspected defect or or manufacturing licensing requirements ssJ1 Procurement documents-failure to comply and, as authorized by of Part 50 of this chapter provided the Inw. the identity of anyone so reporting deviation could, on the basis of an eval-1marmersons, Raconoc will be withheld from disclosure.' untion, create a substantial safety has. ard and h pordon of the faculty con-1 of records 6 21.3 Dennitions' **W the deviation has been offered to anoneww? As used in this part (a) " Basic compo- the purchaser for acceptance; or i nent," when apphed to nuclear power re- (4) A condition or circumstance in- l s1.s1 Pattun to notify. , actors means a plant structure, system, volving a basic component that could i
' Avinoarrv: sec. lat. Pub. L as-70s, se component or part thereof necessary to contribute to the exceeding of a safety stat. 944. sec. 334. Pub. L s!-Is!, 83 Stat. assure (1) ithe integrity of the reactor limit, as defined in the tec!mimt specifi- t 444, see, sos. Pub. L e3438, as stat.1346 coolant pressure boundary, (2) the capa- cations of a licenae for operation issued '
t42 DJs c. sect, sas2. Esse). bility to shut down the reactor and main- pursuant to Part 50 of this chapter. Nms. Psoviszons tain it in a safe shutdown condition, or (e) " Deviation" means a departure (3) the capabnity to prevent or mitigate from the technical requirements included i 3 21.1 Purpose. the consequences of accidents which in a procurement document (see i 21J The regulations in this part establish could result in potential offsite exposures (1) ) . i procedures and requirements for imple, comparable to those referred to in (f) " Director" means an individual, mentation of section 206 of the Energy i 100.11 of this chapter: " Basic compo- appointed or elected according to Isw, l ' Reorganization Act of 1974. That section nent." when applied to other facilities who is authorised to manage and direct requires any individual director or re- and when applied to other activities 11- the affairs of a corporation, partnership sponsible ofBeer of a firm constructing. censed pursuant to Parts 30, 40, 50. 70 or other entity. In the case of an indi-owning, operating or supplying the com, or 71 of this chapter, means a compo vidual proprietorship, rdirector" means ponents of any facility or activity which ment, structure, system, or part thereof the individual. is licensed or otherwise regulated pur- that is directly procured by the licensee (g) " Evaluation" means the process suant to the Atomic Energy Act of 1954. of a facility or activity subject to the accomplished by or for a licensee to de-as amended, or the Energy Recrganiza- regulations m this part and in which term *ne whether a part.icular deviation tion Act of 1974, who obtains information a defect (see i 21.3(d)) or failure to could create a sumntial safety hasard. reasonably indicating: (a) That the 16- comply with any applicable regulation (h) " Operating" or "operatical" means
' cility, activity or basic component sup- in this chapter, order, or license issued the operation of a facility or the conduct plied to such facility or activity fails to by the Commission could cNte a sub- of a licensed motivity which is subject to comply with the Atomic Energy Act of stanual safety harard h I21hh the regulations in this part and consult- } 1954, as amended, or any applicable rule, In an cases " basic component" includes ing servlees related to operstions that are regulation, order, or license of the Com- design, inspection, usting. Or consulting important to safety, mission relating to substantial safety services 1Inportant to safety that are (1) " Procurement document" means a hazards or (b) that the facility, activity, associated with the component hard- contract that defines the requirements or basic compenent supplied to such fa. ware, whether these services are per- which iscilities or bssic co=aaaaa must cility or activity contains defects. which formed by the component supplier or meet in order to be considered accepta- , could create a substantial safety hazard, others. b!c by the purchaser.
to immediately notify the Commission of (b) "Commklon" means the Nuclear (j) " Responsible ofBeer" means the such failure to comply or such defect. Regulatory CommMion or its duly au- president, vloe-president or other in-
' unless he has actual knowledge that thorised representatives. dividual in the organisation of a cor-the Commklora has been adequately in, (c) " Constructing" or " construction" paration, partnership, or other entity formed of such defect or in11ure to means the design, manufacture, fabrica- who la vested with execuuve authority comply' tion, placement, erection, installation, over activities subject to this part.
modification, inspection, or testing of a (k) "Substant al safety hasard" monna I 21.2 Scope-facility or activity which is subject to the a loss of safety function to the extent The regulatins in this part apply, ex. regulations in this part and consulting that there is a mejor reduction in the de-cept as specificsMy provided otherwise in services related to the facility or activity gree of protection provided to pubbe Parts 31,34,3!, ~ . 'e 70 of this chapter, that are important to safety. health and safety for any facility or ac-to each individuo. fi trtnership, corpora. tivity licensed, other than for export, tion. or other entity licensed pursuant to (d) " Defect" means: (1) A deviation (see 121.3(e)) is a pursuant to Parts 30. 40, SC. 70 and 71. the regulations in thh chapter to possess. basic component delivered to a purchaser (1) " Supplying" or "suppiles" means use, and/or transici within the United States source, byproduct and/or special to forthe use regulations in this part if, on the component usedresponsible in a f aculty or an activity subject contractually or to be used forinaabeste facil-nuclear materials, or to construct, man. basis of an evaluation (see l 213(g)), the sty or activity which is subject to the ufacture, possess, own, operate and or transfer within the United States, any deviation could create a stabstantial regulations in this part. production or utilisation facility, and to safety hasard; or . (2) The installation, use or operation g 31.4 Interpretations, each director (see 1213(f)) and respon. of a basic component containing a defect Except as speciScally authertmed by alble of5rer (see i 21J(J)) of such a 11 the Commission in writing, no laterpr=- eensee. The regulations in this part apply tation of the mannW of the meulationt; also to each individual. corporation. sunc mastonal Ceces etII sosept eouset in this part by any ofBeer or employee partnership or other entity doing busi- telephone cans trem ladMduals who wlah rwnmtamian other than a written ness within the United States, and each tonuclear speak u NRc repunentattne safety-mlated eoneerning problenn The loca-ofinterpretation the by the General Counsel director and responsible ofBeer of such sson and telephone numbers (for alghts and wlH be recognised to be binding upon organisation (c)) a productionthatorconstructs (see 121.3 $$/' as mal es neunar hoon) amthe utilisation facility imodCammlasian beensed for manufacture, construction assion- g 21.5 Geummelesalena. or operation (see i 21J(h)) pursuant to I (phundelpt.ta) ~'.It eos) (auants).....C hoopt wh hvise Med in ssi-4 sos ((sis) this set-stso part, all owsnMana and re-Part 60 of this chapter or supplies (see 121J(1)) haste components (see 1213 m (chseaso)....... (sts see-seso ports ecacervag the regulations in this (a)) for a facility or activity licersed. IV (Dauas) ......... (st?) as& sess part should be addassed to the Director. other than for export, under Parts 30. Y (San Francisco).. (41s) thS-4141
- puestat assestes, vot. 43 eso. taa -av. JUNE 4,19FF
. . ~
l$ RULES AND REEULATIONS 28895 Omce of Inspect 2on and Enforcement, reasonably indicating a f ailu e to ecmply of his or her responsibility under this U S. Nuclear Regulatory Commission, or a defect afecting (1) tha conste ction paragraph. Washington D C. 20555. or to the Direc- or operation of a facihty c; an actinty (c) Individuals subject to paragraph tor of a Regional Omce at the address within the United State that is 590jst (b) may be required by the Commission specined in Appendix D of Part 20 of to the licensing requirement under PS-ta to supply additional information related this chapter. Communications and re. 30,40,50, 70 or 71 and ths4 k wi ' 'a 1.is to the defect or failure to comply. ports also may be delivered in person at organization's responsibibty or ui) a the Commission's omces at 1717 H Street basic component that is wi'hir his or- PaocraturNT DocrwrNTs NW., Washington, D C.; at 7920 Norfolk ganizaticn's responsibility AM is sup- $ 21.31 Procurement documents. Avenue, Bethesda. Md.; or at a Regiona' plied for a facill;y or an ac; wity within Each individual corporation, partner. Omce at the locstion specified in Ap- the United States that is sub.tet to the ship or other entity subject to the reg-pendix. D of Part 20 of this chapter. licensing requirements under Parts 30. ulations in this part shan assure that 6 21.6 Post ng reqntrements. 40. 50. 70 or 71. The above notification each procurement document for a fa- i is not required if such individual has Each hdividual partnership corpora- actual knosledge that the Commission cility, or a basic component issued by ' tion or other entaty subject to the regu- has been adequately informed of such de- him her or it on or after January 6,1978 lations in this part. shall post c'arrent feet or such failure to comply. specifies, when applicable, that the pro-copies of the following documents in a (2) Initial notification required by this Visions of 10 CFR Part 21 apply, conspicuous position on any premises, paragraph shall be made within two INSPECTIONS, RZcoras within the United States where the ac- days following receipt of theinformation. $ 21.41 Inspections. tivities subject to this part are conducted NotiScation shall be made to the Direc-(1) the regulations in this part. (2) Sec- tor, Omce of Inspection and Enforce- Each individual, corporation, partner-tion 206 of the Energy Reorganization ment, or to the Director of a Regional ship or other entity subject to the regu-Act of 1974, and (3) procedures adopted Omce. If initial notification is by means lations in this part shall permit duly pursuant to the regulations in this prt. other than written communication, a authorized representatives of the Com-If posting of the regulations in this written report shall be submitted to the mission, to inspect its records, premises, part or the procedures adopted pursuant apprcpriate Omce within 5 days af ter the activities, and basic components as nec-to the regulations in this part is not prac- information is obtained. Three copies of essary to effectuate the purposes of this ticable, the licensee or firm subject to each report shall be submitted to the part. the regulations in this part may, in ad- Director, Of5ce of Inspection and En- 6 21,51 Maintenance of eccords. dition to postins section 206, post a no- forcement. tice which describes the regulations / (a) Each' licensee of a facility or ac-procedures, including the name of the in- paragraph(3) 'Ihe shall written reportbut include, required need notbybethis tivity subject to the regulations in this dividual to whora reports may be made, limited to, the following information, to part shall maintain such records in and states where they may be examined. the extent known conne: tion with the licensed facility or The effective date of this section has (D Name and address of the individ- activity as may be required to assure been deferred until January 6,1978. comphance with the regulations in this ual or individuals informing the part.
$ 21.7 Exemptions. Commission.
, (b) Each individual, corporation, part-
'Ihe Commission may, upon app!! cation activity,(11) Identincation of the facility, or the basic componen suppliedthe nersh!p, or other entity subject to the r of any interested person or upon its own for such facility or such activity within regulations in this part shall prepare
} initiative, grant such exemptions from the United States which fails to comply records in connection with the design, the requirements of the regulations in or contains a defect. manufacture, fabrication, placement, this part as it determines are authorized (1 11 ) Identification of the firm con- erection, installation, modification, in-f by law and will not endanger life or structing the facility or supplying the spection, or testing of any facility, basic { property or the common defense and basle component which fails to comply component cility or tosupplied be usedfor any licensed in any licensed ac-fa-security and are otherwise in the public or contains a defect. r interest- tivity sumclent to assure comptance with [ Norrnemon (iv) Nature of the defect or failure to the regulations in this part. After de-I comply and the safety hazard which is livery of the faciuty or component and
$ 21.21 Notification of failure to comply created or could be created by such de- prior to the destruction of the records or existence of a defect. feet or failure to comply. relating to evaluations (see i 21.3(g)) or (a) Each individual. corporation, part- (v) 'Ihe date on which the information notiScations to the ChmmMion (see b nership or other entity subject to the of such defect or failure to cornply was E 21.21), such records shall be ofered
- regulations in this part shall adopt ap- obtained. to the purchaser of the facility or com.
propriate procedures to (1) provide for (vD In the case of a basic component ponent. If such purchaser determines any i (1) evaluating deviations or (1D inform- which contains a defect or falls to com- such records: ing the 11xnsee or purchaser of the de- ply, the number and location of all such (1) Are not related to the creation of [ vaation in order that the beensee or pur- components in use at, suppued fe, or a abstanual sahty Med, he may au. thaser may canae the deviation to be being supplied for one or mon facmues thorfu neh mords to be destroyed, w evaluated unless da deviation has been or activities subject to the regulations (2) Are related to the creation of a I corrected; and (2) rasun that a director in this part. substantial safety hamard, he shall cause or respons!ble omeer is informed if the (viD The corrective action wl.ich has such records to be ofend to the organi-h construction or operauon of a facility, or been, is being, or will be taken; the name sation to which he supplies basic com-activity, or a basic coamonent supphed of the individual or organization respon. ponents or for which he constructs a fa-for such facihty or c.ctivity: sible for the action; and the length of cihty or activity. (D Pails to ecmply with the Atomic time that has been or will be taken to If such purchaser is unable to make the ENrsy Act of 1954 as amet,ded. or any complete the scuon. determination as required above then the apph&.e rule. tegulation, order or 11- (viiD Any advice related to the defect responsibthty for making the determi-r cense of the substantial Cornmission safcty hasard, or relating to a activity, or failure to comply about the facility, nation shall be tmnsferred to the indi-or basic component that has vidual, corporstion, partnership, or other (1D Containt a defect. The effective been, is being, or will be given to pur- entity subject to the regulations in this virte of thtuurw. graph has been deferred chasers or licensees tmed Jannay" c.1978. part that issued the procurement docu. (4) The director or responsible oScer ment to the purchaser. In the event that W m A hector or responsible oScer may authorize an individual to provide the determination cannot be made at subject b ihe regulations of this part the notincation required by this para- that level then the responsibility shall
- o. s daisuted person shall notify the graph. provided that, this shad not re- be transferred in a atmtlar manner to Cornmission when he obtains information lleve the director or responsible omeer another individual, corporation, partner-NotRAL Rielffts, VOL. 42, NO.104-s40NoaY, JUNE a,19y7
d 28896 RULES AND RE2ULATIONS ship, or other entity subject to the reg- PART 34-LICENSES FOR RADIOGRAPHY ulations in this part, until. If necessary. AND RADIATICN SAFETY REQUIRE-the licensee shall make the determina. MENTS FOR R4D10GRAPNIC OPERA-TlONS J tion. (c) Records that are prepared on1Y g 34.31 (Amended] for the purpose of assuring compliance with the regulations in this part and are 5. In 10 CFR Part 34, I 34.31(a)(2) is amended by changing the words " Parts not related to evaluations or notifications 19 and 20" to read " Parts 19, 20. and to the Commission msy be destroyed after delivery of the fac!!!ty or com- 21 " ponent. l (d) The effective date of the section PART 35-HUMAN USES OF SYPRCOUCT has been deferred until January 6.1978. MATERIAL EnroncentrxT $ 35.31 [ Amended]
- 6. In 10 CFR Part 35, 8 35.31(e) is I 21.61 Failure to notify. amended by changing the words " Parts Any director or respons'ble omeer sub- 19 and 20" to read " Parts 19, 20, and feet to the regulations in this part who 21 ***
knowingly and consciously falls to pro-vide the notice required by 121.21 shall PART 40--LICENSING OF SOURCE 5e subject to a civil penalty in an amount MATERIAL
' not to exceed 85.000 for each failure to provide such notice and a total amount $$ 40.22 and 40.25 [ Amended]
not to exceed $25.030 for all failures to 7. In 10 CFR Part 40, I 40.22(b) is provide such notice occurring within any amended by changing the words " Parts period of thirty consecutive days. Each 19 and 20" to ruad " Parts 19, 20, and day of failure to provide the notice re-quired by 121.21 shall constitute a sepa. 21."
. rate failure for the purpose of computing 8. In 10 CPR Part 40, I 40.25(e) is the applicable civil penalty. amended by changing the words "Part Nott--The reporting and record keeping 20" to read " Parts 20 and 21."
requirements contained in this part have been approved by the General Accounting omee under B-180225 (a0 440). PART 70--SPECIAL NUCLEAR MATERIAL
$ 70.19 - [ Amended]
P' ART 31-GENERAL LICENSES FOR 9. In 10 CFR Part 70, I 70.19(c) is BYPRODUCT MATERIAL amended by changing the words " Parts
$$ 31,2,31.S,31.7,31.8,31.10, end 31.11 19 and 20" to read " Parts 19, 20, and ,
( Amended] 21." e
- 3. In 10 CFR Part 31, 8 31.2(a) is Dated at Washington, D.C., this 1st ,
amended by changing the words " Parts day of June 1977* 19,20. and 36" to read " Parts 19,20,21. , and 36." For the Nuclear Regulatory Commin.
- 4. In 10 CFR Part 31. Il 31.5(c)(10). sion. -
31.7(b), 31.8tc), 31.10(b)(3), and 31.11 Santers. J. CatLx, (D are amended by changing the words Secretary of the Commission.
" Parts 19 and 20" to read " Parts 19,20.
and 21." f ra Doc.TF-15987 riled 477.8:45 aml I I i i [.' P9008At R0085798 VOL. 43, NO.100-m0NDAY, JUNE 4,19y7 L_ -
3 586 RULES AMO REGULATIONS closing date of the co)1 test but in no event of its recent!y published e@lations clear Regulatory Commission. Since the will it be later than r avember 10 of each which require direckrs and itsponsible Commission lacks a quorum (or the year. The exact date time and locLtion officers nf firms and organizations build- transaction of business, the requests of of the contest will tn announced a rea- ing, operating or owning N AC-licensed organizations to postpone the effect date sonable period of tin e prior to Novem- facilities. or conducting Nic"-licensed of 10 CFR Part 21 must be addressed. if l ber 10 through the pu ?lication of a notice activities, or supplymg safety related they art to be addressed at all, by the in the FroERAL REctslER. components to report faHures to comply Executive Director for Operations. Upon with regulatory requirements and defects review of the final rule in the light of 6 91.31 Return of e itrice after contest. in components which may result in a the concerns expressed and after consul-All entries will be vturned, certified. substantial safety haiard. No change is tation with the incumbent Commission-to the participating artists within 60 being made in thost oortions of the reg- ers in accordance with the provisions of days of completion of the contest- ulations now subject to the deferred his delegated authorfty, the Executive Dated: June 30,197 7. eHective date of Januhry 6,1978. This Director for Operations has detennined change in effective date will give persons that it would be in the pubhc interest LYNN A. 3 R E EN W ALT, subject to the rtne sdditional time to to postpone the effective da'e of the Dnal Director U.S. Fish and establish implementing procedures. rule until Augun w,1977. This exten-si n w e persons and maniza-EFFECTIVE DATE: August 10, 1977. l 74-77,8:45 am1 ns a e ruk an aMonal Irn Doch19205 Fue Certain obligations under the effective
" **" * * "8 rule are not imposed until January 6* NRC public informational meeting in Title 10-Energy 1978' whn to put interim implementing pro-CHAPTER l-NUCLEAR REGULATORY FOR FURTIIER INFORMATION CON- cedures in place. The Executive Director COMMISSION TACT: for Operations has also deterTnined that PART 21-REPORTINf, 08 DEFECTS this change in the effective date d the Mr. W. E. Campbell, Jr., Of5ce of f nal rule is a minor amendment which AND NONCOMPLIANCE Standards Development, U.S. Nu- does not substantially modiN existing Reports to the Commission Concerning clear Regulatory Commission Wash-
- h Defects and Noncompliance ir n, D.C. 20555. (phone: 301-443-a afet c d ea Cerrection curity, or substantive or procedura)
SUPPLEMENTARY INNRMATION: rights and that he has been delegsted . In FR Doc.77-15987 appearing in the On June 6,1977, the Nuclear Regulatory authority to issue it. Since the purpose issue for Monday, June 6,1977 on page Commission published in the FEDERAL of this change in the effective date of the on page 28894 l 2L3(d)(1) should REctsTra (42 FR 28891-28896, FR Doc. final rule is to allow organizations to ob-28891's read a follows. e7-15937) amer:iments to 10 CFR Parts tain more information about its provi-6 21,3 Definitions, 2,81,34,35,40 and 70 of its regulations sions prior to imp'lementation. the Exec-
. . . . . and a new Part 21-Reporting of Defects utive Director for Oberations also finds (1) A deviation (see 121.3fe> ) in a and Noncomplhnce to implement sec- that notice and public procedure there-basic component delivered to a purchaser tion 206 of the Energy Reorganization on are contrary to the public interest Act of 1974, as an ended (Public Law 93- and thet there is good cause to make this for use in a facility or an activity subject 438,88 Stat.1246-1247). As stated in the change in the effective date of the final to the regulations in this part if, on the FEctRAL REctsTEt notice, the effective rule effective lmmediately upon publica-basis of an evaluation (see 121.3f g)),
the deviation could create a substantial date of the final rule was July 6,1977, tion in che FarR AL RrcIsTER without the safety hazard; or thirty days af ter the date of publication, customary thirty day notice. except for certain portions cf the rule for Pursuant to th'e Atomic Energy Act of which the ef'ective date was spelfically 1954, as amended. the Energy Reorgani-deferred until January 6,1978. The pur- zati n Act of 1974, as amended, and sec-pose 'of the deferred e!!ective date was P T 2-RULES OF PRACTICE to allow organizations to establish and tions 552 and 553 of title 5 of the United PAR REPORTING OF DEFECTS AND implement procedures to comply with States Code, the following change in the NONCOMPLIANCE certain provisicu. of the rule. On June effective date of Title 10. Code of Federal PART 31-GENERAL LICENSES FOR 9,1977, the NRC staff announced that Regulations, Part 21 is published as a BYPRODUCT M,t,TERIAL five public meetings, hosted by each of document subject to codification. PART 34--LICENSES FOY RADIOGRAPHY hts five the uring regional period of' July ices, 12 would be, held through Jub
- 1. In FR Doc. 77-15937 appearing at AND RADIATION f,AFETY REQUIRE, 26, 1977, for the purpose of explcining page 28891 in the PsarRAI. RtetsTra of MENTS FOR PADIOGMPH;C OPERA-TlONS the provisions of the rule and answering June 6,1977, the Ecective Date para-any questions which might be raised con- graph appearing on page 28092 in column
.PART 35-HUr4AN USES OF BYPRODUCT cerning its implementation. As the effec- 1 is revised to read as follows: i MATERIAL . tive date of the rule approached, several organizations expressed concern that EFFECTIVE DATE: August 10. 1977.
PART 40--LJCENSING OF SOLTtCE MATERIAL they would not be able to have adequate Certain cbligations under tne effective mFc es in plam before the e m m WM M hm E 7,- PART 70-SPECW NUCLEAR MATERIAL rule became effective, that they needed Reports to the Cominiw.on Concerning clarification of certain provisions of the (Sec 161 Pub L. 83-703, 68 stat. t.48 (42 De4c*r wid Noncempliance; Extension rule and that it would be particularly US c. 2201H sec. 211. as amended, Pub. L. of EffectNe Date helpful if the effective date of the rule 93-438. 88 Stat 1242. Pub. L. 94-79. 89 Stat were deferred for a period of approxi- 413 i42 US C. 5841).) AGENCY: UE. Nuclear Regulatory Com- mately sixty days after the date of the Dated at Bethesda. Md., this 6th day of mission. last &cheduled regional meeting. July 1977. ACTION: Change of effective date of A. noted in the recently expanded del-egation of authority Io the Commission's For the Nuclear Regulatory Commis-final rule. CUMMARY: 'nle Nuclear Regulatory 3339 3 39 . un 30 1 Ltc V. Gossicx, 6 Commission is changing from July 6, 77-18988p there are at the prtsent time ' Executit e Director for Operations. 1977 to Augtst 10,1977, the effective date only ao quahfied members of the Nu- 1FR Doc 77-19559 Filed 7-C-7';10:47 mmt FIDttAt REGl5TER, VOL 42, NO.130 THURSDAY, JULY 7,19ry C
- ~ ~ - - _ _ _ _ _ _
i . int 1806 N RULR$ by the owner, tl1 e owner may select registration to the l'eterinary Services ceived may be examined at the Com-and employ his own appraiser who representat!ve. minainn's PubHc Doceneet Room at shall appraise the animain and consult All written submimions made pursu. 1717 H 8treet NW., Waahtngton, D.C. with the Veterina 7 Services appraiser ant to this notice 1rllt be made avail. FOR FURTHER ' INFORMATION
' and Attempt to ad ree on the appraisal able for public inst action at the Fed- CONTACT *.
vone. If the twa ' appraisers do not eral Building. 650 i Belcrest Road Edward Poldolak, Offlee of Stan-aFew on the apt rraisal value of the Room 734. Hyattar!!1e, Md., during' aan m als, the ti e appraisers shall regular hours of basiness (8 a.m. to dards Develo,,pmen,t, Regulatory , , , , , , ,U.S.
, , Nuclear ashing-select a third ag;)ralser who will be 4 30 p.m., Monday to Friday, except ton, D.C. 20684, phone 301-443-4010.
employed by Vete rinary Services. The holidays) in a manner convenient to three appraisers shall attempt to the public business t7 CPR 1.27(b)). SUPPI.EMENTARY INFORMATION: agree upon an ap praisal value for the Comments submitted should bear a In the most common type of license animala Any appe Wal agreed upon by reference to the datt and page number for the medical use of byproduct mate-these uuw aps ral pers will be final. of this issue in the Punsaar. RacIsvra. rial. NRC restricts the physician's use Done at Washington, D.C., this 13th of radiopharmsenticals essentiauy to those clinical pm mune approved by
. . . . . day of March 1978. ,
the Food and Drug Administration
- 3. Section 54.7 ( L) and (b) would be Non-It la hereby ePrtifled that the eco- (FDA) in the product's labeling. The amended to read: nomic and infistionar ' effects of this pre packade insert, a part of the product posal have been carefilly evaluated in no. labeling, has scientific, medical, legal 954J Destewh aad disposition of sal- cordarce with Executh e Order No.1142L and administrative significance. The male. . . K. Arwxr.r. purpose of the pacirare insert is to (n) Indemnity i nr affected animals AcfingDeputs 4dministrator, provide the physician with specific in-and expose 1 anin1 als destroyed under Fei erizaryServices, formation about the use of the radio-this Part shsil be paid only after Vet- (FR Doc. 78-7163 DDd 3-14-78; 8:45 and pharmaceutical. 'Ihis information, trinary Services d)tains the written which is reviewed and approved by agreement of th t owner to accept FDA includes:
from the United 1 ttates compensation [7590-01] 1. The chemical and physical form which shall be eq aal to two-thirds of of the drug: tha appraised va) 2e of each antmmt, NUCLEAR REGULATORY 2. Recommended usual dose and not to exceed $300 per head. COMMISSION usual done range; (b) Affected ar lmals and exposed 3. Indications and usage (clinical animals shall be destroyed on the [10 CFR Port 35] procedurest premises where held, pastured or 4. Route of administration to which penned at the ime of appralsal; the labeling applies; except that sucr animals may be HUMAN U5ES OF BYPRODUCT 5. Contraindications; and m:ved for destru tion to a location MATERIAL 6. Warnings. Other than the i remises where ap. Under the socalled Group
- medical s' raised wWn mot Pment to such loca- Change In L! cense Conditions for licenses. NRC restricts the physician's tien is oproved in advance by the Certain Medical Licenses choice of clinical procedures to FDA Stcte reprtsentat. ve and Veterinary approved procedures. This is accom-Services representLtive involved, and AGENCY: U.S. Nuclear Regulatory plished by listing in 10 CFR l35.100 such animals are not to be processed Commission. each radioisotope, the chemical and for human food. 'I he carcasses of the ACTION: Proposed rule
- physical form of the radiopharmaceu-animals destroyed shall be disposed of tical and the authorized clinical proce-by burial or incineaation.
SUMMARY
- The Nuclear Regulatory dures. Each time FDA approves a new Commission is considering amending clinical procedure for a radiopharma-
. . , . . its regulations (a) to permit physicians ceutical listed in (35.100. NRC must greater latitude, when they use certain consider amending 935.100 to include
- 4. Section 54.8 w >uld be amended to low risk diagnostic radio- pharmaceutt- the new procedure.
res4: cals, by no longer designating autho- The purpose of this proposed rule ISU Payments to < wners for animals de. rized clinical procedures and (b) to change is to delete the specification of stroyed. delete from several licensing groups the diagnostic clinical procedures from certain chemical forms not approved the lists of radiopharmaceuticals in (a) Owners of al rected animals and by FDA. The Commission believes Groups I. II and III of f 35.100. This exposed animals c estroyed in accor- that the use of these would permit a physician to use these dance with this Ps rt shall be paid an radiopharmaceuticals for diagnostic diagnostic radiopharmaceuticals for indemnity by the 17nited States equal clinical procedures not yet approved clinical procedures not included in the to two-thirds of thi appraised value of by FDA entails low risk to the patient. product labeling. each animal so destroyed, not to provided the chemical and physical exceed $300 per hei 4. form, route of administration and the "The most common types of NRC specific (b) Veterinary S rvices may indem- dosage range remain the same as licenses for the medical uses of byproduct Itify owners up o the limitations specified in the radiopharmaceutical material are the Group medical licenses specified in this P trt whether or not labeling. under i 35.14 that apply to those radioactive the Date particir ates in indemnity p2yment. DATES: Comment period expires May materials listed in i 35.100. The radioactive 16,1978. materials listed in I 35.100 are divided into (c) Animals pres < 'nted for appraisal six groups, each group having similar re-as purebred shall >e accompanied by ADDRESSES Written comments or quirements for user training and expert. their certificate of vgistry at the time suggestions for consideration in con. ence, fact 11 tics and equipment. and radiation of appraisal. or the 'shall be appraised nection with the proposed amendment safety procedures. Oroups I. II and III are as grades: except t tat, in the absence should be submitted to the Secretary I p ur of such proof of purebreeding, the of the Commission. U.S. Nuclear Reg- radiopharmaceuticals for therapeutic proce- Y ae o Deputy Adml.ilstr1 tor shall grant a ulatory Commission. Washington, D.C. dures; and Group VI is a list of radioactive reasonable time i or the owner to 20555. Attention Docketing and Ser- medical devices for both diagnostic and obtain and preseni his certificate of vice Branch. Copies of comments re. therapeutic procedures. FrDERAL REGISTIt, VOL. 43. NO. 53-FRIDAY, MARCH 17,1978 i
\ , . ?
- i I,
PROPOSED emas 11207 The use of an approved drug for in- ency function, the radiopharmaceuti- todinated human serum albumin, rose dications that have not been approved cal manufacturers did not request bengal or sodium todohippurate;
- in the product labeling has been dis- FDA approval. (2) Iodine-125 as sodium iodide or fl.
1 cussed by FDA in a FEDuaA1. Ractsysa Under the Atomic Energy Act of brinogen; C announcement (40 PR 15392) concern- 1954, as amended, the Energy Reorgs- (3) Chromium 51 as human aerum
.- ing the "Iabeling for Prescription nization Act of 1974, as amended. and albumin: (4) Oold-198 in colloidal form; Drugs Used in Man *. Section 553 of title 5 of the United (5) Mercury 197 as chlormerodrin, i
* *
- the labelins is not intended either to States Code, notice is hereby given (6) Mercury-203 as chlormerodrin:
- preclude the physician's use of his best that adoption of the following amend. (7) Selenium 75 as selenomethionine; >
Judsment in the interest of the patient or to ments to 10 CPR Part 35 is contem. (8) Strontium-85 as nitrate; tmeose liability if he does not fonow the packase inant. m WA) Comunissier plated'9 35.14(b), add a new paragraph (9) Technetium 99m as pertechne-1.In tate, labeled sulfur colloid or macrong-clearly recognians that the labelins of a (6) to read as follows.
) marketed drus does not always contain all gregated human serum albumin; 9 35.14 Speelfle lleenses for certain groups (10) Ytterbium-169 as diethylenetri-phys la s t th pr use th of medical uses of byproduct amaterial. aminepentancetic acid (Sn);
drus in good medical precuce. Advances in (11) Indium-113m as chloride; medical knowledge and practice inevitably (12) Any byproduct material in a ra-e o e e e precede labelind revision by the manufac- diopharmaceutical prepared from a turer and formal label approval by the Food reagent kit listed in paragraph (C)(4) and Drug Administration. Oood medical (b)*** practice and patient interesta thus require (6) For Groups I, II and III any 11- of this section; and that physicians be free to use drugs accord- censee using byproduct material for (13) Any byproduct material in a ra-ins to their best knowledse and judgment. clinical procedures other than those diopharmaceutical and for a diagnos-Certainly, where a physician uses a drus for specified in the product labeling (pack- tic use involving imaging or localir.ing a use not in the approved labelins. he has age insert) shall comply with the prod- for which a " Notice of Claimed Inves-the responsibliity to be wellinformed about uct labeling regarding- Ligational Exemption for a New Drug" (1) Chemical and physical form; (IND) has been accepted by the Food en if raYonale o und (11) Route of administration; and and Drug Administration (FDA). dence, and to maintain adequate medical re. (c) Group HL Use of generators and (111) Dosage range. cords of the druss use and effecta. but such reagent kits for the preparation and usage in the practice of medietne is not in use of radiopharmaceuticals contain. vlotation of the Federal Food, Drus and e e e e e Cosmetic Act. ing byproduct material for certain di-
- 2. In i 35.100, paragraphs (a), (b) and agnostic studim The Commission believes that the (c) are revised to read as follows- (1) Molybdenum-99/ technetium-99m use of radiopharmaceuticals listed in ** g ,~
Groups I, II and III for diagnostic l 36.100 Schedule A-Groups of snedical p"f",, ,"[g," clinical procedures not yet approved uses of byproduct malertal (2) Technetium-99m as' pertechne-by FDA entails low risk to the patient. (a) Group L Use of prepared tale for use with reagent kits for prep-provided the chemical and physical radiopharmaceuticals for certain ding- aration and use of radio pharmaceuti-form, route of administration and the nostic studies involving meneurementa cals containing technetium 99m as disage range remain the same as spect- of uptake, dilution and excretion. This provided in paragraphs (c)(4) n'nd (5) fled in the radiopharmaceutical label- group does not include imaging or 1o. of this section; ing. Therefore, the Commission is also enH=ation studies. (3) Tin-ll3/ indium 113m generators proposing to amend i36.14 to require (1) Iodine-131 as sodium lodide,10- for the elution of the indium-113m as the physician to comply with the dinated human aerum albumin, la- chloride; pm ue labeHng 6 W to thee beled rose bengal, triolein, modium 10 (4) Reagent kits for preparation of dohippurate or sodium lothalamate; technetium-99m labeled: and II op fo c - (2) Iodine-125 as modium lodide,10 (1) Sulfur colloid,
*" dinated human serum albumin, oleic (ii) Iron-ascorbate-dietylenetriamine-rod lab Hng 11 t ee epentaccetic
- 3) ed ocobala.
th mmi ion inue to strict the uses of therapeutic radioac.(4) 2 Cobalt-40 as labeled cyanocobala- (iv) Hu' man serum albumin micros-f' tive drugs in Groups IV and V to clini. , . cal procedure approved by FDA in 2 (v) Folyphosphates-the product labeling. The uses of ra. (6) Chromium St as modium chro- (vi) human aerum l dioactive medical deviess in Group VI mate or labeled human serum albu- ,3 % will continue to be restricted to clini. min; (vil) Distannous et'idronate complex; l cal procedures determined to be safe (6)Irou-69 as citrate; (viii) Stannous pyrophosphate-and effective by NRC in consultation (7) Technetium-90m as pertechne- (12) Human serum albumin; and
- l. with its Advisory Committee on the tate; and (5) Any generator or reagent kit for i Medical Uses of Isotopea. (8) Any byproduct material in a ra- preparation and diagnostic use of a ra-i The Commission is alsa proposing to diopharmaceutical and for a diagnos- diopharmaceutical containing byprod-i update the lista in Groups I, II and III tic use involving measurements of uct material for which generator or by deleting certain chemical forms not uptake, dilution or escretion for which reagent kit a "Nottee of Claimed In-
! approved by FDA. These chemical a " Notice of Claimed Investigational vestigational Exemption of a New forms, such as todopyracet, modium Exemption for a New Drug"(IND) has Drug"(IND) has been accepted by the l }' distrisoste and distrimonte methylglu. been accepted by the Fbod ami Drus Food and Drug Mministration (FDA). camMe, were originally placed in the Administration (FDA). I groups when the Atomic Energy Com. (b) Group JL Use of prepared . . . . . ! mission regulated the safety and effi- radiopharmaceuticals for diagnostic (eses. st let. Pub. L 88-103,80 Stat. SOS, i cecy of radiopharmaceuticals incorpo- imaging and localisation studies. ese ces UAC. 3111. sastr. ase. set Pub. L rating byproduct material. Since then, (1) Iodine 131 as sodium lodide,10 so-ass,8B atet.134s te UAC. Se41).) 'I these chemical forms have been re- dinated human serum albumin, ans-placed by other products and, when croaggregated lodinated human aerum Dated at Washington, D.C., this i the FDA took overJhe safety and efft- albumin, colloidal;(microssgregated) lath day of March 1978. fBEAL ASSISTE, vet. 48 NO. SMERAY, MAAOf IF,19F0 V s l l 4
- - , . - - - _ _ _ - _ - . , _ - , - _ - _ _ _ _-,_ n_ _ _ _ _ - _ _ _ _ _ _ . _ _ - . _ _ _ _ , . _ .
11208 N 855 For the Nucisar Regulatory Coss- regulating the amadii at uses of radio 4- Based ce past esa trience and the mission. sotopes and to provt le a basis for poe- an==aata and advic e of the public. Saams. J. CxuJr. sible future rula-h ne he nouce re- other Federal T t =_ the States and - Secretary g/the Commission. quested comunents 01 i apecific issues as NBC's Advisory Cosmittee on the [" [ fit Doc.18-fl87 Filed 3-14-78; 8-44 aml _follows: Medies! Uess of Isota pes,the h = b To what extent a bould the protet> sion has developed the following tion of the patient be considered in policy statement to gu6de its regula- [7590-01] NRC's regulaMon of ;he marum3 use of tion of the medical uses of radiotso- [10 CPR Part 35] byproduct material? Areas of possible topes:' regulatory involveneat by NRC in 1. De NRC w!Il coi ttinue to regulate afGULATIO90 OF 1 HE MEDICAL USES this ares include: the medical uses of radioisotopes as OF RADOC150TOPf5 L Evaluauon of s hysician's clinical necessary to provide for the radiation p qualif! cations, safety of workers had the general 7.7'e p aey 3,,, , 2. Selection of pal lents for diagnos- public. tic or therapeuuc pt, m iures. 2. The NRC will r rgulate the radi-AGENCT: Nuclead Regulatory Com- 3. Selection of la betrumenta to be ation safety of patienLa where justified 1 mission. used in performizg diagnostic or by the risk to patien .s and where vol-ACTION: Advanm . notice of proposed therapeutic procedu. es. untary standards, or compliance with rulemaking. 4. Selection of rai lloactive drugs or these standards, are Irtadequate. devices to be used. 3. The NRC will a inimize intrusion
SUMMARY
- The :Tuclear Regulatory Commission (NRC has under consid- g ,
N W mN NWW d@ W ta en reg $' tu n to radi tive r n of *edi in regulating the .nedical uses of ra- to be W dioisotopes. This NRC policy state- 7. Proper measurenents of the dose IL RaTI4 Sala ment la intended to inform NRC 11* the patient receives, censees, other Fed <ral and State agen- 8. Calibration of diagnostic equip- The NRC and ita predecessor the cies and the pubt,c of the Commis- ment and dose-men turing instrumen-Atomic Energy Conulission have regu-ston's general intelition regarding the tation. lated the medical usa a of radloisotopes regulation of the nedical uses of ra- since 1944. AEC reco inized that physi-
- 9. Qualifications a ! paramedical per-dioisotopes. It is eupected that future sonnel, such as tec. inologista, nurses, clans have the prim try responsibility NRC activities in the medical area, radiopharmacista knd radiological for the protection )f their patients -
such as promulgallon of new regula- physicists, and and designed its regt lations according-tions and developtte st of cooperative 10. Reporting to MRC the patient ly.The physicians wrre required to be relationships with >ther Federal agen- and/or the patient's physician, misad. licensed by the Stat < . and their app 11 cies, will follow thi.i statement of NRC ministration of radli > active material or cable training and experience were policy. radiation from dev ces Incorporating evaluated in consulta. tion with the Ad-visory Committee ori the Medical Uses ,- are due on or radioactive material Prozzat REctsTra of Isotopes. This relrulation has been DATE: Comment; before May 16.197 In addition to the notice and other public announce- generally oriented toward assisting ADDRESSES: Selid comments and ments. NRC directl r contacted more qualified physician; toin discharging suggestions to: Serretary of the Com- than 30 physician g- oups, professional their responsibilities patients. IIow-mission. U.S. N Iclear Regulatory societies, public int Prest groups, and ever, regulation by (EC/NRC has at Commission. Wastilngton. D.C. 20555. Federal agencies, tt e 25 NRC Agree. one time or anot 1er encompassed Attention: Docke .ing and Service ment States and a everal non Agree- nearly every aspect af the delivery of Branch. Copies of comments may be ment States. radioisotope medicai services to paw-examined in the: fuelear Regulatory The meetings of ? RC staff with the tients. The broade it regulation oc-Commission Pub!!i Document Room, public and the Adyta cry Committee on curred between 196 : and 1975, when 1717 II Street NW , Washington D.C. Medical Uses of Isol opes were held on the Food and Drtg Administration May 6.1977. in Sil rer Spring. Mary. (FDA) exempted trom its require-FOR PURTIIER INFORMATION land. The meeting record was held ments for ne r drugs all CONTACT *, open for 70 days foll ) wing the meeting radiopharmaceutical s regulated by Mr. Edward Podclak. Office of Stan. for the receipt of ' critten comments. dards Developm> n t. U.S. Nuclear Over 90 people pa rticipated in the .The NRC licenses ridioisotopes in three Regulatory Con- mission. Washing. public meetings and 33 comments were categories: buroduct. >iurce and special nu. ton, D.C. 20555. 331-443-6910. received for the ree' ,rd. Transcripts of clear material. The PG C does not regulate the meetings and c pies of the corn- natursur owurrtns or aeterator produced SUPPLEMENTAL INFORMATION: menta may be exar lined in the NRC radiotnotopes. The tern byproduct matertal In 1976. NRC. wi' h a view to possible Pubtle Document toom at 1717 II means any radioactive 1naterial texcept spe. ctal nuclear matertall y ended in or made ra-changes, began rr viewing its regula- Street NW., Washin tton. D.C. dioactive by exposure la the radiation ince-tions regarding the medical uses of ra. dent to the process of groducins or utilir. ins dioisotopes, originsfly promulgated by I. PROFoSED Pot c7 STATEMENT special nuclear matert ,1. The term source the Atomic Erergy Commission This NRC po!!cy statement is in- matertal means sti uiantum. thortum. or ( AEC). On April : 1.1977. NRC pub- tended to inform NI LC licensees, other any combination there< f. in any physical or lished a meeting ni ttice in the FEDERAL Federal and State agencies and the chemical form, or (2) o es which contain by REctstan (42 FR ' t0691), inytting the public of the Comm aston's general in. wetsht one-taentieth , f one percent co os public to commen . On NRC's regula- tention regarding he regulation of percent) or more of n uranium. (u) thor. tions concerning medical practices, the medical uses of radioisotopes. It is lum, or ( 111 ) any c< .mbinauon thereof. The FrDERAL REcr irra notice and re- expected that futuri . NRC acitivites in 8 m
- material does n ,t include sputal n+
1 ted public ann >uncements stated the medical area, s uch as promulga- n cans lu nium sn 233. thit the purpose <if the public meet- tion of new regula: lons and develop- enrtched in the tsotope 233 or in the tsotope ings was to receis e written and oral ment of cooperative relationships with 235, or (2) any materta artiftetally enttched ._ comments that th< Commission could other Federal ageno es, will follow this by any of the foresot is, but does not in-use in deciding fu ure NRC policy in statement of NRC p ilicy. ciude source matenaL ( N00 GAL RBettfag, VOL. 48, MO. SS-JelDAY, MAROI 17, 1978 l l A
- i .
~
4972 RULES AND REGULATIONS keting year beginning October 1.1918, [7590-01] ganization Act of 1974. as amended, is determined to te 615 million and sections 552 and 553 of Title 5 of
"*1v the United States Code, the following pounds. The sum of Lhe preliminary amendments to Title 10, Chapter I, farm marketing quotan for the 1978-79 CHAPTit 6-NUCtgAR REGULATORY Co m ss a Code of Federal Regulations. Part 35 marketing year is 636 313,044 pounds. are published as a document subject to The quota of 615 million pounds, less a PAaf 35-HUMAN U$ES Of BYPRODUCT codification.
' national reserve of 1,590,000 pounds MATERLAt 1. Paragraph (cX3Xx) of I 35.100 is would result in a naLlonal factor of s,eep ucensing b Certein medical Um amended by changing the period at the end of paragraph (cx3Xx) to a se-
'964 81nce farmers are n >w making their AGENCY: U.S. Nuclear Regulatory micolon, and adding a new paragraph Commission. (cX3Xx1) to read as follows:
plans for 1978 producIlon of burley to. bacco and need to know the marketing ACION: Final rule. I 35.100 Schedule A Groupe of medical quota for their farma for the 1978-79
SUMMARY
- The Nuclear Regulatory uses of byproduct materlat marketing year, it 16 hereby found Commission (NRC) is amending its that compliance with ;he 30-day effee, regulations to add a new reagent kit to . . . . . ,
its list of authorized radioactive drugs. 5 tive date requirementa of 5 U.S.C. 553 reagent kita, and procedures. The (C) * * * [ is impracticable and contrary to the amendment adds to these lista a kit for (3) * *
- r public interest. preparation of technetium 99m la. (xt) Medronate sodlum for bone i beled medronate sodium for bone imaging. [
FinA1.R 71.s imaging. This action is being taken by (Sees. 81.161b. Pub. L 83-703, as amended, ' Accordingly 7 CF1 Part 726 la NRC because of the recent Food and 68 Stat. 935,948 (42 UAC. 2111,2201U
*A t t na royal o amended to read as to lows: (Sec. 201. Pub. L 03-438, as amended. 88 Section 726.11 an< the preceding for bone imaging. stat. Im H2 584 m centerhead la revisec to read as set EFFECTIVE DATE February 7,1978.
Dated at Bethesda, Md. this 1st day forth below, effectise for the 1978 of February 1978. crop o! burley tobaccc . FOR FURTHER INFORMATION For the Nuclear Regulatory Com-CONTACT: g John E. Bowyer, Division of Fuel Lzz V. Oossicx, urnta- 9M RK INo EA L Cycle and Material Safety. Office of Execuff t'e Director j 726.11 Burley tobaccon expected uti. Byproduct Matertal",10 CFR Part 35. Bection 35.100 of 10 CFR Part 35 susotAnna a-ceoamiz; nom. enocacuess, lization and exports for the 1978-79 AND M SC'8RAC"C8 marketing year. lista groups of medical uses of radioiso-th a SMONmmm (b) National Fact < r. The national "gra d ex r ce, a factor determined t;nder $ 319(e) of cilities and equipment, and radiation ps.de. ore of meeedes P.,eining to Con.ent the Act is .964. safety procedures. Order "a "- m vneide. wee of meeeee (c) National rescr< e. The national The notice of proposed rule making pree * =- = - e.x se Considee Consent reserve for making ec rrections and ad. that was published in the FEDEaAL Agree nents justing inequities in old farm quotas Racistra on January 21,1974 (39 FR Correctia 2384) stated that the groups of 11 and for establishing quotas for new farma la 1.590,000 pot nds-c uses wwld W amenM imm In FR Doc. 78-17ES, appearing at time to time to add new radio-pharma- page 3088 in the inn 2e for Monday, (seca. 301. 319. STS,52 a 4t. 38, as amended, ceuticals, sources, devices and uses as January 23,1978; oni page 3089 in as stat. 23,52 stat. os. s i amended. 7 UAC. they are developed. The Food and $ 2.34* "(a)" should be removed. 1301.1314e.1378.) Drug Administration (FDA) has re-4 Nors.-The Agricultui al 8tablitzation and cently approved a "New Drug Applica- , Conservauon Service Il ha determined that tion" for technetium.99m as labeled y - this document contains 6 major proposal re- medronate sodlum for bone imaging outring preparauon of a n Economic Impact and this procedure is hereby added to tyge 374 --- - 7 and Isesshlee Eudiengee statement under Execui ive order 11821 and Group III. OMB Ctreular A-107, e id certiftes that an Because these amendments relate CHAPTER 16-80CUtiftti AND EXCHAMOE i l Economne Impact 8tata nent has been pre. solely to procedural matters, the Com. N"**'DN
- mtanton has found that good cause N esse h aA&s01 Signed at Washing on. D.C., on Jan. exists for omitting notice of proposed 4
uary 31,1978. rule making, and public procedure FART Sll-INTERPRET,LTfvE RALEASES thereon, as unnecessary Since the RELATING TO ACCOUImMG MATTEtl !/ - 8Tsv Amt N.BurTu, amendment re?leves licensees from.re-
', Acting Adminta 'rutor, Agricul- strictions under regulations currently 84* B-3'*# ' ^^ ; 8'nenne e tural StaMiisi tion and Con- in effect, it may become effective with- Starr AccouwTIwo Etrt.1mrts No. 20 servation Serv ce. out the customary 30 day notice. '
Pursuant to the Atomic Energy Act AGENCY: Becurities and Exchange
!PR Doe. 78-3138 Filtd 3-1-78; 3.54 pel of 1954, as amended, the Energy Reor- Commission.
PgestAt teeeStat, VOL. 43, NO. 36-TUESOAY, PettUARY y,1978 I i 4 4
. -- )
y 3 m - a E 2167 r ._ i. f rulesandregukations /W This sechon of the FEDERAL RfG4 STER centoms e.gulatory docwnents havng general appi, cob.hty and legal effect most of wNch or. heyed to and cod.hed in the Code of f ederal Regulohons. whch is published under So hurs pursuant to 44 U.S C.1510.
- The Code et fed rol Regvianons a no6d by the Sup.natendent of Documents. Prices of new books are listed in the first FEDERAL REGISTER issue of each L ****
t 16325-01) [1505-01] cilities and equipment, and radiation i safety procedures. I Title bAdministr. Mye Personnel Tme 14 -Energy The notice of proposed rule making i that was published in the FEDERAL CHAPTER l-CIVlt $fR (ICE COMMi$$ TON CHAPTER l-NUCI IAR REGULATORY REGISTER on January 21,1974 (39 FR COMk f553ON 2384) stated that the groups of 11-PART 213-EXCE 'TED SEEVICE censed uses would be amended from PART 20-$7ANDAR >$ FOR PROTECTION time to time to add new
. Department of He sing and Urben AGAINST , ,ADIATION radiopharmaceuticals, sources, devices nevele, none and uses as they are developed. The
' Coution Signs, Lebels siensis, and Centrols Food and Drug Administration (FDA)
I AGENCY: Cisil ser ce Commission. has recently approved a "New Drug l Corri clian Application" for technetium-99m as 4 ACTION: Final rule. human serum albumin for heart blood BUMMARY: The fol lowing three post. In FR Doc. 77-: 6867 appearing at pool Imaging and this procedure is e tions are excepted 1 rom the competi- page 64619 in the issue for Tuesday, hereby added to Group III. l tive service under S< hedule C because December 27,1977 in the lith line of Because these amendments relate they are confidenti. tl in nature: one $ 20.203(cM 6)(1) or page 64620, the solely to procedural matters, the Com-Special Assistant to :he Deputy Assis- .y rd "im,possible" should have read mission has found that good cause p ssible . - exists for omitting notice of preposed tant Secretary for tegulatory Func-r tions,9ne Special A< sistant for Neigh- rulemaking, and public procedure v thereon, as unnecessary. Since the borhood Concerns, asd one Special As-amendment relieves licensees from re-
'sistant to the Deput r Assistant Secre- [7590-01] strictions under regulations currently tary for Neighborho ad and Consumer in effect. It may become effective with- '
Affairs. PAaf 35--HUMAN U$ES Of SYPROOUCT out the customary 30-day notice. '
- EFFECTIVE DATE: January 16.1978. MATEalAt Pursuant to the Atomic Energy Act g
- of 1954. as amended, the Energy Reor-FOR FURTIIER INFORMATION Group Licensing for Certain Medwei Uses ganizhtlon Act of 1974, as amended.
' CONTACT: and Sections 552 and 553 of Title 5 of William Bohling 2- > 2-632-4533. AOENCY: U.S. Nuclear Regulatory the United States Code, the following Commission. amendments to Title 10. Chapter I.
Accordingly, S CPI ; 213.3384 (1),(5), AciION: Rule. Code of Federal Regulations, Part 35 (6), and (7) are addet as set out below; are published as a document subject to
SUMMARY
- The Nuclear Regulatory codification. 4
$ 213.3384 Department of flousing and Commission is amending its regula. 1. Paragraph (cX3) of $ 35.100 is l
- L'rtan Developmen Lions to add a new reagent kit to its amended by changing the period at ;
- lists of authorized radioactive drugs! the end of paragraph (ix) to a semico-
. . . . r . reagent kits, and procedures. The lon. -and adding a new paragraph
;x (1) Office of (Ac" A ortstant Secretarvamendment preparationadds to these lists99m of technetium a kitla-for (cM3Xx) to read as follows:
for Nefahborhood O panizations, Fol- beled human serum albumin. This rad- t 35.100 Schedule A4eoupe of Med6 cal i watary Associationa and Consumer topharmaceutical may be .used for Uses ef Bypeeduct Material 7 Proteeffon. * *
- heart blood poolimaging. ,
EFFECTIVE DATE January 16 1978. * * * *
- FOR FURTHER INFORMATION (c) Oroup.lff. Use of senerators and (S) One Special usistant to the CONTACT
- reagent kits for the preparation and Deputy Assistant Se tretary for Regu. use of radiopharmaceuticals contain-latory Functions. Mrs. Patricia C. Vacca. Division of ing byproduct material for certain di-
- 16) One Special As listant for Neigh, Fuel Cycle and Material Safety, agnostic uses.
y# borhood Concerns. Office of Nuclear Material Safety i i (7) One Special tasistant to the and Bafeguards, U.S. Nuclear Regu- .. . . . . Deputy Assistant Set retary for Neigh- " "' (3) Reagent ILits for preparation of borhood and Consulm rr Affairs. - 20 h : 1-427 2-technetium-99m labeled;
* (5 UE.C. 3301,3302; EC 10677,3 CFR 1964 SUPPLEMENTARY INFORMATION: i, i- 1968 Comp, p. 318.1 . Notice is hereby given of the amend- i
. .- . . . I O' ,
ment of the Nuclear Regulatory Com. I For.the United at Aes Civil Servloe mission's Regulation, Human Uses of (xfHuman serum albumin for heart
' ;J Coramkalon. Byproduct Material.010 CFR Part 35. blood pool imaging.
w. Jh ins C. BrnY. Section 36.100 of 10 CPR Part 35 . Effbetice datet .These amendments Kree, ticeAssistant lista groups of medical uses of radioiso- become effective on January 16, 1978.-
, . _ ,]- to the Jommissioners. topes that have similar requirementa unem st, leth, Pub. 1. 83-703,' as smended.
- l y IFR Doc.18-1307 File'1 1-1318,8.45 aml 'for user training and experience, fa- 68 8 tat. 935,948 (4211.8.C. Sill,220I).)
?, 4 , . .,,.
C' ' ~ PESERAL B0688T% VOL. 43, NO.10-MONDAY; JANUARY lo, l#9 - i i r
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,~ 2168 RULES AND REGULATIONS actuating cylinder (Sec. 201. Pub.1. 93-438, as amended. 88 is unnecessary. Theri' fore, the AD la main landing gea stat.1242 4 42 U.S C. 5841).)
being amended to rel eve operators of rod end bearing as sembly and replace-airplanes modified in accordance with ment of hollow sIlank rods, if found. Dated at Bethesda, Md., this 6th day the service recommen lation from com- with solid shank rods. The hollow of January IM8. pliance with the AD. rods. due to qualily control error, had For the Nuclear Regulatory Com- Since this amendm< nt relieves a re. been installed con rary to the aircraft -~ mission. striction and impost s no additional type design. Lrt V. Oossicx burden on any per .on, notice and EFFECTIVE DATE: January 18.1978. Executive Director public procedure her' on are unneces- ADDRESSES: Pirer Senice Bulletins for Operations, sary and good cause a xists for making the amendment effec fve in less than may be acquired fiom the manuf actur-er at Piper Aircrtit Corp. 820 East (FR Doc. 78-1227 Filed 1-13-18. 8.45 mm) 30 days. Bald Eagle Stree .. Lock Haven, Pa. DRAFTING INFt IRuATION 11745. A copy of t le service bulletin is contained in the ilocket in the Office f The principal auth prs of this docu-Title 14-Aeren weies and space ment are G. Nakag ,wa Pacific. Asia fegon Ica, . Region, F. Kelley,1Tght Standards CHAPTER 6-FIDERAL AVIATION ADMINt5- Service, and S. Podb tresky, Office of FOR FURTHE1: INFORMATION TRATION, DEPARTMiNT OF TRANSPORTA. the Chief Counsel. CONTACT:
, flON a s P ado!'rloM OF THEAurnourNT f 3 h f Docket No.1754 ); Amdt. 39-3125] Federal Accordingly, pursuaat to the author. Manufacturing Branch.
PART 39-A'IRWOR 'HINES$ DIRECTIVts ity delegated to me b:' the Administra- Building. J.F.K International Air-tor. I 39.13 of Part 3 ) of the Federal port, Jamaica, IN .Y.11430. telephone AutovWsN Heavy in< untries Medel MU-28 Airy ones Aviation Regulations :14 CFR 39.13)is 212-995-3372. amended by amend.ng Amendment SUPPLEMENTAI;Y INFORMATION; AGENCY: Federal, Aviation Admints- 39-1844 (39 FR 16876 , AD 74-11-01, as There have been reports of the inad-tratica (FAA) DO.' amended by amendntent 39-1859 (39 vertent substitutibn of hollow shank ACTION: Final rul ? FR 19203) by revising the applicability rods in lieu of solhi rods by the suppli. statement to read as 1Dllows: er of the rod enc bearing assemblies.
SUMMARY
i This tmendment amends Since this defect (nn etist in other air-an airw arthiness directive Mrtscarsa Hr.m Inc rrares, tern. Appues craft of similar lype and the defect ( AD ,"xisting applicable t< MitsubishI IIeavy to Mitsubtshi M6de s MU-2B, MU-2B-10 MU-2B-15. MU ,2B-20. M U-2 B- 25, can cause failurP of the assembly Industries Model l !U-2B airplanes by MU-2B-ac and MU-2B-35 airplanes when subjected tc retraction or.exten-changing the app icability section to mept taose mimla&s modified in ac- sion loads, a rule I AD) is being issued relieve operators if certain modified airplanes from cc mpliance with the *Nndat o n No 0 7d ptembe m nt M h pan Gen necessam in AD. Compliance 1 , not necessary for 12. 1974. or an FJ,A-approved equiv- view of the effect on air safety, notice airplanes incorpor ating the specified alent. or public proced are hereon are im-modification, This amendment tecomes effective practical and go >d caus? exists for making the rule MD) effective in less EFFECTIVE DAT C: January 30,1978. January 30,1978. than 30 days. C mpliance schedtJe-As prescribed in (Seca. 313(at 601, and 6C3. Federal Attation
" Act of 1958, as amended (49 U.S C.1354(at DRAFTING [NFoRMATIoM et Department of ADDRESSES: Th r applicable service 1421. and 1423 t see. e U.S.C. 16554 c)); 14 The principal a,ithors of this docu-recommendation may be obtained Transportation CFR 11.893 Act (49 ment are K. Tunj-an. Flight Standards from: Mitsubishi IIeavy Industries, 5-1, M ar1 nouchl 2-chrome, Nors -The Federal Ariation Administra. Division. and Tliomas Regional C.Counsel.
Halloran. tion has determined t:iat this document Esq., Office of the Ltd., Chiyoda-ku. Tokyc 100. Japan. It has been det<.rmined that the ex-Prvice recommenda. does not contain a majo; proposal requiring .he proposed regula-of an Econ imic Impact State- pected impact of .1 that the proposal A' copy of the a
! tion is contained i i the Rules Docket. preparation ment under Executtw Order 11821. as tion is so minimi r Room 916, 800 In dependence Avenue ** ue rder 11949, and does not warrant 1,n evaluation.
BW., Washington, 1C.20591. oM$Nrcu[ar f07 Anorrion or ruz Aurnournt FOR PURTHEF INFORMATION Issued in Washingt<n. D.C., on Janu-ani , pursuant to the au. 3 I CONTAC"r: ary 5,1978. Accordingly, J. A, FERRAREst, thority delegated Lo me by the Admin-O. Nakagawa, 'hief. Engineering Achng Director, 1strator, 5 39.13 a f the Federal Avi-and Manufactur ng District Office, Flight Stondards Serrtec, ation Regulation; (14 CFR 39.13) is Pselfic-Asia Reg on. P.O. Box 4009, amended, by issu ng a new airworthi-Honolulu. Hawn .i 96813, telephone IFR Doc. 78 943 Filed l-13-78. 8.45 aml ness directive as f 4 lIlows: 808-546-8650. Ptrra AracRArt Con u Applies to model PA-SUPPLEMENTAll Y INFORMATION: [491043] 31T mimlanes. senal umWs alt-This amendment : mends Amendment (Docket No~ 77-EA-61 ' Amdt. 39-31241 7400002 through 31T-772o040 certificat. 39-1844 (39 FR 161 76), AD 74-11-01, as ed in su categod as. Comphance required amended by Ame idment 39-1859 (39 PART 39-AltwoafMI et$$ DetECTTVES within the next fifty hours in service FR 19203), whict1 requires repell'ive '*"
* ^
% Ah fn((s a ea'y mp tahed checks prior to t!' ' first takeoff each day for cracks an i distortions in the AGENCY: Federal A viation Admints- ta) To preclude' malble failure'of the t front windahleids on Mitsubishi MU- tration (FAA) DOT, main landins par nctuauns cynndu rod, 2D tirplanes. The AA has determined end beartns assemti tes accomptish the in.
that if the modl ',ication covered in ACTION: Final rule. - ( AD) is appilca- described i spection and repta< ment where required. Recommendation .
SUMMARY
- This rul in the * . natruction" poruon of Mitsublahl Servic itember 12.1974, is ble to Piper PA-31'l type airplanes. Piper Aircraft Cor1 Service Dulleun No.
r No. 027, dated Be $70, dated June 22. ,> 77. incorporated, comyllance trith the AD The rule requires an pspection of the PEO8 tat REGl$ttR, VOt. 43, NO.10-MONCAY, AANUARY 16, 1978 e r
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**. O I .
11208 PROPOBED RULES For the Nuclear Regulatory Com- regulating the medical uses of radio!- mission. Based on past experience and the SA' FUEL J. CmLK. sotopes and to provide a basis for pos- comments and advi'e of the public. Secretary of Ae Commission. alble future rulemaking. The notice re- other Federal agene.es, th' States and Quested follons: comments on specific issues as N R C's Advisory C, n.mit ce on the tF*R Doc 78-7167 m: 3-16-78. 8 45 aml _ _ '_ Medical Uses of 1sttoxs. the Com nis-To what extent should the protec- sion has develo. J the following Y390-03} tion of the patient be considered in policy statement tc guide its regula. NRC's regulation of the medical use of tion of the medical uses of radioiso- [10 CFR Part 35] byproduct material? Areas of possible topes: ' regulatory involvement by NRC in 1. The NRC will continue to regulate REGULATION OF THE MEDICAL USE5 this area include: OF RADIOL 50 TOPES 1. Evaluation of physician's clinical the medical uses of radioisotopes as qualifications, necessary to provide for the radiation Proposed Policy Statemen, 2. Selection of patients for diagnos- public. safety of workers and the general AGENCY: Nuclear Regu'atory Com- tic cr therapeutic procedares, 2. The NRC uill regulate the radi-mission. 3. Selection of instruments to be ation safety of patients where justified used in performing diagnostic or by the risk to patients and where vol. ACTION: Advanced notice of proposed therapeutic procedures. rulemaking. 4. Selection of radioactive drugs or . untary standards, or cornpliance with 8 e devices to be used. these standards are inadequate. U ' E C 5. Selection of procedures to be per* 3. The NRC will minimize intrusion cration the following proposed policy formed- Into medical judgments affect!ng pa- , statement regarding NRC's future role 6. Selection of dose level (Quantity of tients and into other areas traditional- i in regulating the medical uses of ra- radioactive material or radiation dose) lyLice considered to be a part of the prac. of medicine' dioisotopes. This NRC policy state- to be used. ment is intended to inform NRC 11 7. Proper measurements of the dose II. RATIONALE N censees, other Federal and State agen-eles and the public of the Commis- the8. patient receives' Calibration of diagnostic equip The NRC and its predecessor the ston's general intention regarding the ment and dose-measuring instrumen-- Atomic Energy Commission have regu- , regulation of the medical uses of ra. tation' alifications of paramedical per- lated the medical uses of radjoisotopes dioisotopes. It is expected that future 9 Qu since 1946. AEC recognized that ph NRC activities in the medical area. sonnel, such as technologtsts, nurses. clans hate the primary responsibility such as promulgation oi new regula- radiopharmacists physicists, and and radiological for the protection of their patients tions and deselopment of cooperative and designed its regulations accordmg. relationships with other Federal agen- 10. Reporting to NRC, the patient ly. The physicians were required to be cles, will follow this statement of NRC and/or the patient's physician misad. licensed by the State, and their appil-policy. ministration of radioact! e material or cable training and experience were radiation from devices incorporating evaluated in consultation with the Ad-DATE- Comments are due on or before May IG,1978. riscry Committee on the Med; cal Uses radioactive material' PrreAI. RrcrsTr.n In addition to the of Isotopes. This regulation has been notice and other public announce. generally oriented toward assisting ADDR ESSES. Send comments and ments. NRC directly contacted more Qualified physicians in discharging suggestions mission. U.S. to: Secretary of the Com. than 30 physician groups, professional their respons!bilities to patients. How. Nuclear Regulatory , Commission. Washington, D C. 20555, societies. pub!!c interest groups, and ever, regulation by AEC/NRC has at l Federal agencies. the 25 NRC Agree- one time or another encompassed Attention: Dock eting and Servlee Branch. Copies of comments may be ment States, ment States and several non-Agree. nearly esery aspect of the delivery of examined in the: Nuclear Regulatory The meetings of NRC staff with the radioisotope medical sersices to pa. tients. The broadest regulation oc-Commission 1717 11 Street Public DocumentD.C. NW., Washington. Room, public and the Advisory Committee on curred betue(n 1962 and 1975, when Medical ay Uses
,n of Isotopa were held on the Food and Drug Administration land. The meeting er Spm Mam @ A) m mMed from ha re p FOR FURTIIER INFORMATION CONTACT.. record was held ments for new drugs all !
Mr. Edsard Podolat, Office of Stan. open for thefor 70 days receipt of following written the meeting radiopharmaceuticals regulated by comments. dards Development. U.S. Nuclear Over 90 people participated in the { Regulatory Commission. Washing. public meetings and 33 comments were .ne NRC lleen.aes radiolsotopes in three ton. D.C. 20555, 301-443-6910. recei ed for the record. Transcripts of categories byproduct. soarce and special nu. SUPPLEMENTAL INFORMATION. the meetings and copies of the com- clear matertal The NRC does not regulate naturally occurring or accelerator produced ments may be examined in the NRC rad 20tautopes. The term byproduct materia] In 1976. NRC, with a view to possible Public Document Room at 1717 11 mearu any radioactive material tercep changes, began reviesing 'ts regula- Street NW., Washington, D.C. tions regarding the fnedical uses of ra. ctal nuclear matertal) yielded in or made ra-dloisotopes, originally promulgated by L PRorosEn Poucy STATgMENT d) actar by exposure to the radiation incl. the Atomic Energy Commission dent to the process of producing or utilir.ing This NRC policy statement is in- special nuclear matertal The term source ( AEC). On April 21. 1977, NRC pub-lished a meeting notice in the PEDERAL tended to inform NRC licensees other material menna all urantum, thortum, or REctstER (42 FR 20691), inviting the Federal and State agencies and the any combination chemical form,thereof,in or (2) cresany physical which or contain by public to comment on NRC's regula- public of the Commission's general in. melsht one taentieth of one percent to o5 tions concerning tnedical practices. tention regarding the regulation of percent) or more of ti) uranium. (11) thor-the medical uses of radioisotopes. It is lum, or a tti) any combination thereof The FEDERAL REGISTER notice and re- espected that future NRC acitivites in S urce material does not include special nu-lated that thepublic purposeannouncements of the public meet- tionstated of new the medicaland regulations area, such as promulga. '[,*M"[utonium develop- 3. u urr ranfurn ings was to receive written and oral ment of cooperative relationships with enrtched in the isotope 23J or in the taotope comments that the Commission could other Federal agencies, will follow this 235, or (2i any matertal artiftetally ennched use in deciding future NRC policy in statement of NRC policy. by any of the foregotna. but does not in. ciude source matenal. FIDERAL RiotSTER, VOL. 43, NO. 53-.4tIDM, MAROf 17,19rs 6
l PROPOSED RULES 11E09 AEC. During this period AEC regulat- NRC's regulation of the medjeal use of shows an average dose rate from
, ed the radiation safety of workers and byproduct material? radiopharmaceuticals of 1 mrem / year the general public and the safety and From the standpoint of authority, it and an average dose rate from diag-efficacy of radioactive drugs and de- is clear that NRC can regulate the nostic radiology of 72 mrem / year in vices with respect to patienta. AEC rnedical uses of byproduct material to 1970.
regulation included production of the protect the health and safety of users The following quotation is from the radioisotope, manufacture of the final of this material. for instance, patients. NAS-BEIR report: radioactive drug product or device, dis. In licensing the possession and use of In the foreseeable future, the major con-tribution, use and disposal of the prod- byproduct material. NRC establishes bt ' ucts. In 1975, the FDA terminated the limita within which physicians exer. t 'u n natural s$ exemption for radjopharmaceuticals, cise professional discretion. From the ia e ground with an average n-hole body dose of stating that it would now regulate the standpoint of policy, these limita about 100 mrem / year, and medical applica-aalety and efficacy of radioactive depend upon how NRC views the po- tions which now contribute comparable ex-drugs with respect to patients. ( As tantial hazard to the patient's health posures to vartous tissues of the body. %fedi-noted later in this statement, FDA and safety in the uses of the byprod- cal exposures are not under control or gul6 does not regulate the physician's rou. uct material. The greater the potential ance by regulation or law at present The tine use of radiopharmaceuticals.) At hazard to a patient from the byprod- use of ionizing radiation in medicine is of the same time, NRC withdrew from uct material or its use by a physician, t:emendous value but it is essential to regulating radioactive drug safety and the more NRC may elect to circum- reduce exposures since this can be accom-efficacy, stating that it would regulate scribe arens that might ctherwise be glished without loss ofebenefit and at rela-aim is not to as within the discretion of tt ely los cost the radiation safety of the workers { gar ,D and the public. The 1976 Medical - vidual but also to have procedures carried Device Amendments to the Food. Drug The first part of NRC's policy state' out with maximum efficiency so that there and Cosmette act extended FDA's au- ment indicates that NRC will continue can be a continuing tnerease in medical thority over tnedical devicca (including to regulate the medical uses of radio- benefits accompanied by a minimum radF devices containing radioactive materi. isotopes as necessary to provide for atton exposare. als) in a way similar to its authority the radiation safe,ty of workers and the general public. NRC will act to help ensure that ra-over drugs. diation exposure to patients is as low NRC's authority to regulate domes. This is the traditional regulatory as is reasonably achievable, consistent tically the medical uses of byproduct function of NRC for all uses of by. with competent medical care and with material is found in the Atomic product, source and special nuclear minimal intrusion into medical judg-Energy Act of 1954, as amended. For material. It is a regulatory role that ments. NRC will not exercise regula-example, section 81 of that Act autho. was not questioned by any of the com- tory control in those areas where, rizes NRC to issue general or specific menters but, rather, it was consistent- upon careful examination, it deter-licenses to applicants seeking to use ly recognized as a necessary role in the mines that there are adequate regula-byproduct maternal for * *
- medical medical uses of radioisotopes. tions by other Federal or State agen-therapy * * *." Section 81 directs NRC NRC's regulation of the radiation cles or well administered professional to regulate the manufacture, produc- safety of workers and the general standards. Wherever possible. NRC tion. transfer, receipt in interstate public in the medical uses of radioiso- will work closely with Federal and commerce, acquisition, ownership, pos- topes is relinquished by NRC to Agree- State agencies and professional groups session, import and export of byprod- ment States; dc?s not overlap with .og uct material. Ptnally. Section 81 also FDA's activities; 13 in harmony with directs that: regulation by the Department of rp it on to limit ece y patient radiation exposure. However.
Transportation Social Security Ad-The Commiston shall not perm!t the dis. ministration and the Joint Commis- there are specific areas discussed in tribution of any byproduct material to any Incensee. ar.d shall recan or order the reccl sion on Accreditatlan of Hospitals; and Section III of this policy statement of any distributed material from any licens-dos etails with Occupational Safety where NRC will regulate the radiation ec, a ho is not equipped to otmene or falls to and Health Administration regulation safety of patients to heIp minimize un-observe such safety standards to protect of the work place for the use of natu, necessary patient exposure. health as may be estabhshed by the Com. rally-occurring and accelerator pro- The third part of NRC's policy state-mission or who uses such materta! tn viola. duced radioactive materials. ment indicates that NRC will mini-tion of law or regulanon of the Commluton The second part of NR'C's policy mize its intrusion into medical judg-or in a manner other than as disclosed in statement indicates that NRC will reg. ments affecting the patient and into the application therefor or approved by the ulate the radiation safety of patients other areas traditionally considered to Commmon. where justified by the risa to patients be a part of the practice of medicine. Co:nmission regulations, for the and where voluntary standards, or The Commission recognizes that phy-most part set forth in 10 CFR Parts 30 compliance with these standards, are sicians have the primary responsibility through 36. were promulgated to carry inadequate. As noted before, NRC has for the protection of their patients. out the broad regulatory scheme en- the authority to regulate the radiation The Commission believes that basic visaged by section 81. For example, safety of patienta. decisions concerning the diagnosis and Part 35 establishes regulations specific The NAS-BEIR' report discusses treatment of disease are a part of the to human uses of byproduct material. limiting the exposure of the popula. physician patient relationship and are FD A's statutory authority (Federal tion to medical applications of ionizing traditionally considered to be a part of Food. Drug and Cosmetic Act, as radiation. That report, which includes the practice of medietne. NRC regula-amended. 21 U.S.C. 301 et seg ) does all medical uses of ionizing radiation, tions are predicated on the assumption not diminish NRC's authority. Where that properl) trained and adequately NRC's and FDA's authorities overlap, informed physicians will make dect-the respective authorities can be har- state- sions in the best interest of their pa-i monized by interagency agreement. men sp t$alNx lud u nt tients. The central question in the April 21, ' National Academy of Sciences Advisory The regulations try to find a balance 1977. Frornat. Racistra notice is a $** N', ((gf,*,,,rt between adequate controls and avoid-question of policy not authority, Effects on Populauons of Empusure to Iow ance of undue interference in medical namely: Judgments. A consequence of too Inels of Iontrins Radiauon. Nauonal Acad. 3 To what extent should the protec- emy of Sciences-National Research Coun. much regulation could be poorer tion of the patient be considered in ett Washington, D C. (1972 t health care delivery to patients. A con-PEDERAL Rfot$ Tit, VOL, 43, NO. $brtJOAY, MARCH IL 1978 l l l t
- --- -- . -. -_ _. - . _. - . - _ - . = .- . , - - - .
4 11210 PROPOSEO RULES s - sequtnce of leaving to physicians the to NRC m'<*dministrations of radioac. quirement is that the physician's majority of the decisions concerning tive material to be exclusively the training include " supervised examina-thilt patients is that the physicians practice of medicine or a part of physi- tion of patients to determine the suit-trill make mistakes. The tightest regu- clan-patient relationships. As de- ability for radioisotope diagnosis and liti:n of physicians
- decisions by Fed- scribed in detail in Section III, the recommendation on dosage to be pre-ers!, State and professional groups will Commtalon intends to regulate these scribed.
not be able to prevent future incidents areas of patient radiation safety where The Commission recognizes that the l In tha medical uses of rantoisotopes. justified by the risk to patients and selection of patients for diagnostic or , Ths Commission recognizes that where voluntary standards, or compli. therapeutic procedures is basically a l FDA regulates the manufacture and ance with these standards, are inad, matter of medical judgment. Diagnos- 1 intzrstate distribution of drugs,includ- equate. tic procedures have a low patient risk in3 those that are rad!cactive. FDA and therapeutic procedures are spe-also regulates the investigational and III. NRC PosITrow oN SrscIrte Issers cla!! zed and patient specific. Radioac-research uses of drugs as well as the The following represent the Com- tive drug manufacturers provide guld-ance on patient selection and contrain-specific dures found guidance in the on doseslabeling' product and proce. missi n s position on the specific dications in the product labeling. Sup-However, FDA does not have the au- issues raised in the April 21,19'IT, FED- plemental voluntary guidelines on thority to restrict the routine use of 3.RAr. 0691), Rzctstra announcement (42 FR limiting patient radiation exposure, in-drugs to procedures (described in the cluding the standpoint of patient se-product labeling) FDA has approved 1. EVALUAT!oM or PHYSICIANS
- CLINICAI.
as safe and effective. Indeed NRC is QUaltricATtoNs e e nMbution to unnecessary pa-tha only Federal Agency that is cur. tient exposure from improper selec. rently authorized to regulate the rou. NRC has always required that 11 tion of patients is believed to be small. tin 2 use of radioactive drugs from the censees be qualified by training and Therefore the Commission does not standpoint of reducing unnecessary ra. experience in the handling of radioac- major anticipate the need to limit extent, the physician,. to any diation exposure to patients tive material from the standpoint of s discre. The Commission believes that the radiation safety of workers and the tion in selection of patients. Because
- diagnostic use of radloactive drugs is, general public, the NRC does not evaluate physician in most cases, clearly an area of low The Commission believes that it is qualifications for the general license, radiation risk to patients. Therefore' necessary to continue to evaluate phy- the Commission will continue its NRC will not control physician's pre sicians' clinical qualifications prior to minor restriction in the general medi-rogatives on patient selection, instru. Issuance of NRC licenses. At this time hibiti g a ment selection, procedure selection, there is no alternative method of de' nis tion o rad drug selection and dose level for most termining if a physician, not certified pharmaceuticals to a woman with con-dia.nostic uses of radioisotopes. For by the American Board of Nuclear firmed pregnancy or to persons under all therapeutic uses of radioactive Medicine or the American Board of 18 years of age. This restriction does drugs, and in certain diagnostic uses-. Radiology,is competent to use byprod. not affect specific licensees.
for example, the use of phosphorus 32 uct material. Ilowever, the Commis- s. setzcTton or INsTRewrNTs To as for localization of eye tumors-the sion also believes that, as this field of UsED IN PERFORMINo DIAGNOSTIC on risk to patients is not low. The risk of medicine continues to mature, other TuzRArrUTre rnoczncazs tissue or organ damage (or even death) alternatives will replace the NRC eval. is inherent in the use of therapeutic untion of clinical qualifications. NRC evaluation of a physician's levels of radioactive drugs. NRC will NRC has for several years accepted qualifications includes an evaluation
' continue to restrict the uses of thera. certification by the American Board of of training in radiation physics and in-peutic and certain diagnostic rad.oac. Nuclear Medicine and the American strumentation.
tive drugs to the indicated procedures Board of Rad! ology a.s sufficient evi- s tinst ents f r p that have been approved by FDA.The dence of clinical competence in the f g a e NRC will not control the physicians' fields of nuclear medicine and radi- cedures is, like patient selection. bast-t prerogatives on patient selection and ation therapy, respectively. It has re* cally a matter of medical judgment. 1 instrument selection for therapy pro. cently determined that certif! cation by There are also voluntary guidelines , cedures, because these procedures are the American Board of Radiology in available on the selection, calibration so specialized and patient specific. Diagnostic Radlology, with Special and maintenance of instrumentation. Congress recently gave FDA author. Competence in Nuclear Radlology, is Again, diagnostic procedures have low patient risk and therapeutic proce-j lty to regulate med! cal devices, similar sufficient evidence of clinical compe* dures are specialized and patient spe-to FDA's authority to regulate drugs, tence in nuclear imaging procedures. cific. NRC does not currently restrict but with additional authority to re. Based on specific assessments in con
- strict the routine use of medical de. sultation with its Advisory Committee selection of instruments and does not anticipate the need for doing so in the vices as may be necessary to provide on the Medical Uses of Isotopes, NRC future. The Commission recognizes t
reasonable assurance of their safety will continue to expand its use of the that FDA will regulate the investiga-i and effectiveness. FDA has not yet various board certifications as satisfac* tional and research uses of medical de-had sufficient time to implement its tory evidence of adequate clinical vices under its new legislation, the full authority to regulate medical de. training and experience for the medi- Medical Device Amendments of 1970 vices containing byproduct, source or cal uses or radioisotopes. NRC will (Pub. L. 94-2951. The Commission also special nuclear material. Therefore, also work closely with the professional recognizes that these amendments NRC will continue to restrict physt. societies to assist them in developing give FDA new authority to restrict the 1 clan's uses of these medical devices, suitable permanent alternatives to routine use of medical devices under both for diagnosis and therapy, to NRC's evaluation of physicians
- clini- such conditions as may be necessary to those procedures that NRC has deter. cal qualifications. provide reasonable assurance of their mined (in consultation with its Adviso*
s stitcTroM or r4rtENTs roR
!so op to be s f and eff tv IAnonic OR THERArEM PROCEWREs 4. smtoM or radio 4CTIM DAUos OR The Commission does not consider NRC currently evaluates a physi. micts r er Ustn
- equipment calibration, qualifications cian's clinical qualifications to use ra- The NRC now restricts a physician's of paramedical personnel or reporting dioisotopes on humans. One NRC re- selectfun of radioactive drugs by limit. .
I FEDERAt afGilite, VOL. 43, NO. $3-falOAY, MARCH IT,1978
_ . . _ _ . _ _ _ - _ . _. . _ __ -. ~ . _ - __ __ _ - _ _ - - _ __ PROPOSED RULES 11211 ing the distribution of the radioactive cedures for whteh there is substantial labeling. NRC regulations are more re-drugs to those products meeting FDA evidence of safety and effectiveness, strictive than FDA regulations. requirements. The physician is thus that is, to those procedures approved Elsewhere in this tasue of the Frnta-restricted to using radioactive drugs in the drug labeling. According to AL RectsTER is a proposed rule that subject to an PDA-approved " Notice of FDA's statement on drug labeling: would delete the specification of the Claimed Investigational Exemption The FDA Commissioner clearly recognizes clinical procedure from the lists of the for a New Drug"(IND) or an FDA.ap* that the labeling of a marketed drus does diagnostic radioactive drugs in proved "New Drug Application" not alssys contain a!! the most current in, f 35.100. However, this proposed rule (NDA). NHC regulates the manufac- formation available to physicians relatins to would place limitations on a drug's use ture and installation of teletherapy the proper use of the drug in good medical for prcedures not speciftfed in the i devices as well as the integrity testing practice. Advances in medical knostedse package insert. 2 of these and other radioactive medical and practice inevitably precede labeling re- As noted in Section II of this policy devices during use, liowever. NRC vision by the manufacturer and formal la- statement, the radiation risk' to the 4 does not now require that medical de. belins approval by the Food and Drug Ad. patient from most diagnostic nuclear
'*U vices containing radioacthe material c I1 cal practice and patient inter.
meet FDA requirements, eats thus require that physictans be free to M b M M eant h M use M The Commission believes that it is use drugs according to their best knostedge therapeutic levels of radioactive drugs. necessary to continue its restrictions and judgment. Certainly. when a physican Those few diagnostic procedures on the availability of radioactive drugs uses a drus for a use not in the approved la. where the risk to the patient is high to those that meet FDA requirements. belins. he has the responsittlity to be well. are not listed in K 35.100 but are the NRC will study and assess with FDA informed about the drus and to base such subject of specific license authoriza-4 the necessity for a similar NHC re. use on firm scientific rationale or sound tions and will continue to have the i quirement for radioactive medical de. medical evidence, and to maintain adequate ejinical procedure specified. medical records of the drugs use and effecta, i vices. but such usage in the pracuce of medietne is s. set.rcTroN or Dost trvrL (QUANTITY In those cases shere several not m vtolation of the Federal Food. Drus or RAD!oAct!VE MATERIAL oR RADIAT!oM radiopharmaceuticals hase been ap- and Cosmette Act. proved by FDA for the same proce- Dost) TO BE UsED 4 dure, the Commission does not plan to Basically. NRC issues two types of II* As noted in Item 2. selection of pa-1 restrict a physician's decision regard, censes to medical institutions for the tients, the phystelan's training must a ing which agent to use. The Commis. human uses of byproduct material, the include supervised experience in rec. slon considers the basic decision on medicallicense of broad scope and the ommending proper dosages for specific drug or device selection to be a trad1 medical license of limited scope, patienta. tional part of medical practice. Broad medical licenses authorize The Commission recognizes the se-The Food. Drug and Cosmetic Act multiple quantitles and types of by. lection of dose level is basically a differentiates between pharmacy and product material for unspecified uses matter of medical judgment. The manufacture. Ilowever, no clean line and are issued to institutions that (1) package inserts for radioactive drugs has been established to determine have had previous experience operat- include the recommended usual dose when a nuclear pharmacy has gone ing under a limited medical license and usual dosage range. Because of beyond the ordinary practice of phar, and (2) are engaged in medical re- the many variables that determine the macy (compounding and dispensing) search as well as routine diagnosis and most effective dosage for both the di-and has become a manufacturer. The therapy using radioisotopes. The pro- agnostic and therapeutic use of radiol-FDA is drafting guidelines that will grams under the broad medicallicense sotopes, the NRC does not now regu. define all of those operations (of nu, operate under the supervision of a late, nor does it anticipate the necessi-clear pharmacies) connected with the medical isotopes committee. No physi- ty of restricting in the future, the phy-preparation of radioactive drugs which clans are named as indh1 dual users on sician's selection of dose level. will be regarded as manufacture (and, the license, nor are radioisotopes tunit. l therefore, subject to FDA new drug re- ed to specific clinical procedures. 'F. FRorER MEASUREMENT OF THE Dosa qulrements) and not part of the prac. Lfmited medical licenser specify the THE FATIENT Race 1YEs l tice of pharmacy. In the absence of radioisotopes and the clinical proce- The Commission believes that FDA guidelines, the NRC licenses nu. dures that may be performed by phy- proper measurement of the radioac-clear pharmacies to distribute only sielans named on the lleense. Under tive drug dosage, or radiation dose in those products that they hase pre- limited medical Itcenses the Institu- the case of therapy helps to ensure i pared from FDA approved radio- phar- tional licensee must have a medical that the patient receives what the maceuticals or reagent kita. Isotopes committee and the physicians physician has prescribed and thus j named on the institution a license con- helps minimize unnecesaary radiation r s. sELECrtoM or FRocEDUREs 70 at duet their programs with the approval exposure to patients. NRC now re-FERroRM ED of that committee. Under limited quires most licensees. particularly i NRC evaluates a physician's c!!nical di al H se the authorized diag- those who prepare radioactive drugs b he a pr p i in[ Sc e u ate diagnostle or therapeutic proce- Groups of medical uses of byproduct tion. NRC will study the merita of u dures, limitations. contraindfeations. materia ue s amending its regulations to require
""d 80 forth- The authorized clinical procedures measurement of all diagnostic and The Commission recognizes that the listed in the groups are procedures ap- therapeutic doses of radio pharma-selection of procedures ts basically a prosed by FDA in the drug labeling, ceuticals, regardless of origin.
matter of medical judgment. The Since FDA does not restrict the phys!- Commission does not anticipate the clan to clinical procedures listed in the D fl*k to a paumt fan a false postun need to limit, to any major extent, the or a false nestuve diagnoens through the physician's discretion in the selection
, Radioactive materials in j 35.100 are di- une of a drus for a purpose not fu!1r investi-ofThe clinical vided into als stoups. each group havins sated and specified on the label would be procedures" recognizesthat atmilar Commission requirements for user training and expected to be greater than it is for a In-PDA does not restrict the routine use espertence, facilities and equipment and re- beled use but this rtet is difficult to quanti- , 7 of NDA approved drugs to those pro- diauon safets procedurce fr.
PIceRAL RsetSTER, Vot 43, 800. SS--#RmAY, ANARCH 17, IfrO 1
11212 PROPOSED RULES NRC currently has under consider. State. Federal and private agencies in. any other drug or physicians in any f' i ati:n a proposed rule (42 FR 25743) cluding- the Health Services Adminis- other field of medicine. The purpose of a misadministration ; that could require aanual calibration tration (Medicare and Medicaid j and monthly checks of teletherapy DHEW). the Bureau of Radiological reporting requirement is to allow NRC . t units. This rule has reeched many IIcalth (FDA/DilEW). the Joint Com. to Invest! sate the incident, evaluate t public comments; the comments will rnission on Accreditation of !!ospitals the corrective action taken by the 11 be analyzed and the rule modified, if (JCAli) the American Registry of Ra. censee to minimize the chance for re. i warranted. Based on the disposition of diological Technologista (ARRT), the currence. and. If other licensees could l' this proposed rule on teletherapy call. Registry of Medical Technologists make the same errors, begin generte br.tton, NRC may propose a similar (RMT) and the new certification corrective action which would as a rule for the periodic calibration of bra- board by the Technologista Section of minimum, inform other licensees of I chytherapy sources. the Society of Nuclear Medicine. the potential problem. The Commission also recognizes that As also noted in Item 9. In the near :
- s. cAllanAT!oN or otAGNo1Ttc the majority of paramedical tallied future NRC plans to publish, in the j teutturNT Ano nost utAsURINo health) personnel using radloactive FrDraA1 Rectstra a new proposed rule i
INstacutNTAttoM insterial are not covered by these pro. for misadministration reporting. The
!' The Commission belleves that the grams. Rather they are trained on- new NRC proposal will address:(li the calibration of diagnostic equipment the-job. are not certifled; and many do types of m%iminista stfons to be re. j and dosage measuring devices helps not have their training documented. Ported (2) tne substance and timing of o ensure that the patient receives what Ilowever, the introduction of a rela- the reports, and (3)reports, misadministration the recipients of for exam. . the physician prescribes and thus tively less comprehensive NRC pro. l j https minimize unnecessary radiation gram, such as that in the 1973 AEC ple, the referring physician and possi. l d exposure to patients. NRC presently proposal, of voluntarycould undermine the organizations or those effortative, bly asthewell patient or a responsible rela.
as NRC. requires licensees who prepare active drugs from radioisotope gener. radio. Federal or State agencies relying on IV PUntic Aso Anytsony ComuttTas , stors and reagent kits to describe in more comprehensive guidelines. CouwtxTs i the license applications a method for in the near future. NRC will publish calibration of their dose measuring de. a FEDERA1. Rrotstra announcement The NRC staff met with the public f l I vices. NRC also provides an acceptable withdrawing the 1973 AEC proposal on the morning of May 6.1977, and method for calibrating dose calibra. and substituting an NRC proposed with its Adytsory Committee on the t 3 t
! tors in "A Guide for Preparation of misadministration reporting require
- Med! cal Uses of Isotopes in an after. f
! Applications for Medical Programs" ment. That future announcement will noon public meeting on the same day, I (NUREG-0338 Rev. I November 1977) discuss more thoroughly the reasons The members of the Advisory Com.
that can be obtained by writing to the for withdrawal of the AEC proposal mittee were the chairman Mr. Rich. < Radioisotopes Licensing Dranch Divg. and substitution of the NilC proposal. ard E. Cunningham. Deputy Director ston of Fuel Cycle and Material NilC is studying the various allied of the Division of Fuel Cycle and Ma. j Safety. Nuclear Regulatory Commis. health certification programs current. terial Safety of NRC's Office of Nucle. sfon. Washington. D.C. 20555. ly in effect or being drafted by other at Material Safety and Safeguards; Dr. . 3 NRC presently does not have any re. Federal. State and professional James Quinn from Northwestern Me. i qulrements concerning the calibration groups. If the coverage provided by morial llospital: Dr. Joseph Workman l of diagnostic equipment. Because of these programs is not adequate to pro
- from Duke University Medical Center; the extensive experience of FDA's tect the patient from unnecessary ra. Dr. David Kuhl from the Universtty of i t
I ' Hureau of Radiological llealth and the diation exposure. NRC will work with California tes Angeles: Dr. IIenry ! ] new authority of FDA's Bureau of these groups to develop a new NRC Wagner from John Itopkins Medical Medical Devices. NRC will collaborate proposed rule for the training of allied Institution; Dr. Edward Webster from s with them in their development of vol. henith personnel. Massachusetts Ocneral Rospital; and 4 untary guldeltnes for the routine cali- to. RrronTIMo or uts~toutMtstnutoM of Kentucky.Two Dr. Frank DeLand from the University i bration of diagnostic equipment. At consultants to NRC.
' "" # "I * ' " " *" " " * " ' '
' the same time. NitC will study the ulos wu prviers Inco' nroRutso Captain UniversityWi!!1am Uriner
!!ospital andfrom Duke Dr. Peter
' merits of proposing mandatory re. RADIOACTIVE NArERIAL Almond from the M. D. Anderson Itos. quirements. i As describe in item 9. In 1973 AEC pital, also attended.
- s. Qt'AttricAttoMs or ruAurntcAL rrn. published a proposed rule that would The comments from members of the ,
soMMtt aucu As TrenNotoctsrs, require licensees to report misadminis. public can be classiffed broadly in two Mtmsts. M4otorn4RMActsTs AND Rtoto* trations of radlopharmaceuticals or ra. categories. In the first category, the f LoctcAL rnYstetsis distion from byproduct matertal to phystelans, physicians' groups, phar. On March 9.1973. AEC pub!!shed the Commission and to the patient or mactata' groyps and industry com. (38 Fit 63991 a proposed amendment a responsible relative whenever the"present menta range from statements that regulations are sufficient" to i to its regulations in 10 CFit Part 35 misadminsitration could cause a "de. the "the NitC should not regulate the i
' that would (1) define the activities monstrably adverse effect on the pa-that may be delegated by physicians tient." Ninety eight comment letters use of radiotsotopes in medicine at and those that may not, (2) require were received. most objecting to the all." Many of the comments in thLs j
phystelans to determine that para. proposal for reporting to the patient. category stated that FDA regulates medical personnel have been properly Reasons given for objection to the re. the safety and efficacy of drugs and ' trained, and (3) require medical lleens. quirement for reporting mtsadmints. that NRC should withdraw from this ' i ces to report to the Commisalon and to trations to the patient were: (1) such area and regulate only the radiation the patient misadministrations of ra. reports would constitute self-Incrimi, safety of workers and the general dioactive material. nation. (2) such reportA would in%ite pub!!c. I The Commission recognizes that or increase unwarranted malpractice in the second category. NRC Agree. j there are several organizations cut. suits.131 this would place the govern. ment and non Adreement State radi. - rently involved in developing or pro. ment as a third party in the physician. atton control agencies' comments J %1 ding mintmum standards, guidelines patient relationship. (4) this is a range from statementA that "present or certification for technician training. matter of medical ethics, and (S) there regulations are sufficient" to "much r These programs are admintatered by are no comparable requirements for stronger regulation la necessary " . l reoseAt asomne. vot. 4s. wo. so.esioAY. MARCH 11,1970 I
PROPOSED RULES 11213 Many of the comments in this catego- should not restrict the physician to requirements. The pharmacy, radio-ry note that FDA does not regulate those diagnostic procedurca that have pharmacist and technologist groups the routine uses of drugs and devices been approved by FDA in the labeling. are particularly against NHC granting and, therefore, NHC should regulate One member believes that NHC credentials to paramedical personnel to ensure that the patient is protected should continue this restriction or citing the nurnerous certifications and from unnecessary radiation exposure. that some arrangement should ' be activities of other Federal and State In the area of NHC's evaluation of a made similar to the in house institu- agencies, as well as claiming lack of physician's clinical qualifications, both tion committee review under an NHC NHC authority to regulate in this categories of commenters recommend Broad Medical License. area. The physician groups cite the greater use by NHC of board certifica- Regarding proper measurement of fear that the number of certified tech-tions. Physicians and the industry in the dose the patient receives, the nologists will fall far short of the need general appear to be interested in States urge NHC to expand the pre- for these personnel. mainta!ning NHC evaluation as a sent licensing requirement for men The sense of the Advisory Commit-means of entry into the field. They surement of doses of radioactive drugs tee is that existing certifications coser feel that if NHC withdrew frorn evalu- prepared from radionuellde gener- paramedical qualifications and hospl. ating physician's clinical qualifica- alors, to cover all doses of radioactive tals look rather carefully at these. tions, the institutions or States would drugs regardless of how they are pre- They feel that, in the final analysis, require specialty board certification. pared On the related question of the physicians are responsible for their pa~ They state that there are not enough callbration of diagnostic equ!pment tier,ta and, therefore, are responsible board certified physiclans to fill the and done meuuring instrumentation, for the qualifications of pararnedical demand for services and that board the States favor NHC activity aimed at personnel working under their direc-certification is not necessary for many limiting patients exposures but recom- tion in caring for patienta. With the of the radioLsotope proceduren. The mend that NHC coordinate its activt. exception of physicist's qualifications State radiation control agencies be- ties with FDA's Bureau of Radiologi. for calibretion of radiation therapy, liese that NHC's evaluation of physi- cal llealth and other professional and the Advisory Committee does not ree-clan clinical qualifications is neceuary scientific groups. ommend that NHC become involved in to protect the patient. They feel that The category of physicians, physi- regulating the qualifications of parn-if NHC withdraws there mill be a regu- clan groups, and so on, naries in its medical personnel. latory gap. Some States suggest that a commenta regarding measurement of The States comider misadministra-physician's qualifications should be re. dose and calibration of diagnostic in- tion reporting netauary in order to viewed periodically, for exarnple, every strumentation and dose measuring in- !!mit unnecessary radiation exposure five years, to determine that he is strumentation. Several commenters to patienta. They point out that with keeping abreast of this rapidly chang. state emphatically that NHC has no reporta of misadministrations of by-ing field. bniness regulating in this area. Many product material or radiation from by-The general sense of NHC's Advisory of them state as their reuon the new product material NHC will be able to Committee on the Mediaal Uses of iso- authority of FDA's Itureau of Medical investigate the incident, determine if topes was that NHC shuld continue, Devices and the recent activttles of the corrective action is adequate and, at least for the immediate future, to FDA's IJureau of Hadiological llealth if the problem could occur at other in-examine physicians' clin: cal qualifica- in developing voluntary quality con- stitutions, notif y other licensees tions and should make greater use of trol guidelines. Several other com- Physicians and physician groups arc. the various types of board certification menters state that NHC activities in in general, opposed to NHC requiring or registration, as evidence of ade- this area are both welcome and neces- reporta of misadministrations. They quate qualifications to practice in the sary to limit unneccuary patient expo- cite the low number of misadministra-arcu of nuclear medicine and radi- sures. Bimilar to thc 8t ates' commenta, Lions of radioactive material to date ation therapy, some of these latter commenters ree- combined utth the fear of ms! Practice On the question of selection of pa- ommend NHC ecuperation stth PDA's sulta and the already high truurance tienta. instruments, radionative drugs Ilureau of Radiolostral !!calth and premlurru as the principal reasons for or devices, procedures and dose level, other profestonal and scientific opposing misadministration reporting. the State radiation control agencies groups active in developing guidelines They point out that most misadmihis-be!!cves that NHC should not regulate for donc measurement and instrument trations of diagnostic levels of the selection of patienta or instro- calibration. radiopharmaceuticata do not harm the menta. However, the States believe The consensus of the Advisory Com- patient and are similar to mtwimints-that licenses should specify the per. mittee on the Medical Uses of Isotopes trations of other drugs. They state mitted radioactive matertals and pro- is that NHC would do nell to concen- that medical trutitutions and the redures and abould requite adherence trate its activttles on aMurances that medical profession have procedures to trutructions and done schedules in the patient receives the proper done for dealing with misadministrations PDA approved package truerta. The prescribed by the physician. The Adv1- Beveral commenters question NHC's physictans and the industry believe sory Comm!ttee can see no reuon why authortty to require such reporta, stat-that dcctatoru on selection of patienta, radioactive drug doses should not be ing that this is within the traditional trutrumenta, radioacttse drugs or de- menAured by well-callDrated instrue practice of medicine and such a report-vices, procedures and done letels are mentation prior to administratton to ing requirement would be unique in all mecical decisions and traditionally a the patient. On the other hand, the of medical practice. Seteral com-part of the practice of medicine. They Adttsory Committee is not enthustu- menters do not object to keeping re-commented that NHC should not reg. tic about the idea of NHC requiring cords of misadministrations for on site ulate these arru Borne argued that the calibration of diagriostic instru- exarnination by NHC trupertors, but NHC has no authority to regulate in mentation. The existence of guidelines these commenters feel that more these areas since Congress gave FDA in this area and the market pressures harm than good would result from the authority to regulate the safety on manufacturers to provide quality making such reporta directly to NHC, and efficacy of all drugs and medical instrumentation are tuo examples where they sould become a part of devices that it discuned. the public record. The Adttsory Committee on the On the question of the qualifications The Adytsory Committee on the Medical Uses of Isotopes does not have of paramedical personaci, the physt. Medleal Uses of isotopes does not hate a conscruus on this tasue. The major- clan industry categor? is virtually a coruensus on the tasue of misadmin-Ity of the committee feels that NHC unanimous in its opposttion to NHC istration reporting. The members who MDfsAl 36011793, VOL. 4t NO, SMesoAt MAgOt 11, ltta
11214 PROPOSEO RULES commented are against requiring re. [6210-01) and computer tim e no longer deemed porta of those misadministrations nMessary 2 comp etc the analysis re. having no demonstrable health effecta FEDERAL RESERVE $WTEM quired jn surveytn r the stocks eligible on the patient for the Board s Il t. Further, att anal- [12 CFR Perte 207,220,221] ysts of ava!!able p rice information in. One sencral comment occurred sev. eral times during the morning and (Rest O. T, U. Dxket No. R-0147) dicates that NASLAQ is the most con. afternoon meetings and in many of venient and coml>lete source of bid OfC Li$T REOUIREMENTS and offer data for more methcly the public comments. It concerns the traded OTC stock; in addition to sup. need for unfformity in Federal. State Proposed Rule plying other nect ed data which are and private regulation of the med! cal unavailable from the " pink sheets." AGENCY: Board of Governors of the The proposed ame adments will perrnit uses of radioisotopes. Bescral com- Federal Reserve System. the Board to use survey data from menters call for uniformity between ACrlON: Proposed rule. NASDAQ only. NitC and State regulations, but most Accordingly, puinuant to sections 7 focus on the discrepancy betscen the
SUMMARY
- Ther proposed amend. and 23 of the Sect rities Exchanga Act men regulation of byproduct material and Lions 0, T and 8 BuWemen a to Regula- of 1934, as ameru ed (15 U.S C, 78 g I
will require that and w) the Board proposes to amend the regulation of naturally-occurring dealers must and accelerator-produced radioactive and offers for an OTC subrtit bona fide bids 12 CFR Parts 207, 220, and 221 as fol. stock to an lows. materials and accelerator therapy, automated quotathn system if they One commenter discusses this discrep. are to be counted an market-makers in ancy with regard to therapy. This that stock for the purpose of tring in. PART 207-SECUtlTIES CREDIT SY commenter expresses his concern that g "g" toc . ni um a e PER$0NS OTHHR THAN BANK $, regulatory considerations hate come maker requiremenu for a stock to be BROKER $, OR DIALIR$ to play an important part in dectslon included on the Lt.C under the present making, particularly in matters where rule recognizes t lose dealers who 1. Section 207.50 tx2) and 207.5(ex2) the decision is for a choice among near make " regularly p :b!!sbal bona fide of Part 207, Secui lt!cs Credit by Per-equala. Specifically, he is con erned off[rsf a ." n yers 0 o bc "ed oss that the comretition betacen cobalt
- Doard in 1969 the ' pink sheets" of the 60 and electron accelerator telether. National Quotation Dureau mere the $ 207.5 Supplement apy snay be influenced, not frorn dif. only consistent sou ree of the required ferences in hazards, but because NHC price information. i!nce that time an , , , , ,
regulates cobalt.60 teletherapy ur.ita automated quotatliu. system, t he Na. (d) Rechfremenin for inchadon on and does not regulate electron ami. tional Association <>f Security Dealers List & OTC margt i stock. * *
- erator units Itc feels that physiclans Automated Quotrions (N ASDAQ), (2) Four or mori' dealers stand Will.
may choose the leut regula'ed alter. has been developc0 to a point there ing to, and do in Iket, make a market price information en all stocks on the in such stock ar.1 regularly submit native in for order theto have oriented more time de.Hoard's list can nno be obtained from bona fide bids arv available patient it. The Ib>ard is pi esently usmg data mated quotations s offers to an auto- ystem for their own tnands of their practice, He sucseats from both the Wink shecta" and accounta, or the si nck is registered on 1 that NitC should cooperate with those NASDAQ for its suneys. a securttles exchar1re that is exempted agencies that can regulate acerlerator The propoard arn 'ndment will climi- by the Securities a nd Exchange Com. teletherapy, so that these competing nate the neccaalty of reviewing data muston from rettsi mtion s s a national alternatives receive more uniform reg. frorn the " pink she' ta" most of t hich securities eschana r pursuant to sec. is considered dup) i ative and reduce tion 5 o' the BMu 'itles Exchar.ge Act ulation. lie further suggests that any staff review and cor iputer time. of 1934 (15 U.S.C.16e ). Increase in the regulation of one alter. DATit Comments r mat be recetved on native would be counterproductive to or before April 14.11 73. * * ' '
- public health and safety.
ADDREZS. Secret.i ry, Daard of Got. (t) Requirement 6 for continued in. V. Conct.vston ernors of the Feda si Heserve System, clusion on List of C TC margin stock. Washington. D C. 0 '551. This proposed polley statement on FOlt FUltTIIEH * * ' *
- INFORMATION NHC's regulation of the mtstical taes CONTACT: (2) Three or mor - d<alers stand stil.
of radioisotopes is published with the Laura 1(emer. Ch et Attorney, Secu. Ins to, and do in i bet, make a mariret expectation that public cornment util rities Regulation. Division of Ilank. in such stock att I regularly subrnit improse the ulttrnate Commisalon de, it:u Hupervision and Regulation. bona fide bids anc offers to an auto. cision. To that end,it would be helpful Hard of Govern its of the Federal mated quctations a latem for their own If responses include the repons for a Heterse Hystem. Washington. D.C. accounta, or the at xk ts registered or. 20$51,202-452 271 1. a securities enchan te that la exempted particular point of view or recommen. dation' BUPPIMf3'TAH1 INPOHMATION. by the Snurttles a nd Exchange Com i The luard propom s to amend the miarton from regist ration ss a nations; 13t y of M n98 2 1 0and 94 8 For the Nuclear Herulatory Com. data from the "ptnt sheets" when sur. - - mission. seying stocks for inclusion on the PAgf 220 -CREDi1 BY BROKER $ AND Bat'st J. Clltt.K. Hoard's List of 01 C margin Stocks. I secrrfary 4/fAe CommisstorL Most of the data is now duplicative of DEA WAS material from NAN I)A Q. anet retter. 2. Section 220 841 X2) and 220.8(IN2) l IFH Due.it.7100 ylled 316 70. 8 45 mmt Ing it requires an e penditure of staff of Part 220, Cred L by Brokers and l [ Pt908AL 09006ft8, YOL. 40, 000. SS-PGf0a7, AsA00417,1918
25994 RULIS ANO REGULATIONS if it has been detei rnined by a State or [7590-01] sanization Act of 1974. as amended. d Veterinary Bervice i Inspector through Title 10-Energy $e U 1 States Co e. t e ollowin epidemiological in estigation that she amendments to Title 10 Chapter 1. is not an affected or exposed animal AP ER I-NUCLEAR REGULATORY Code of Federal Regulations. Part 35 and she is accom' >anled by a rartift. COMMI55 TON are published as a, document subject to codification. cate; PART 35-HUMAN U5ES OF (6) A mare not t red on a knswn in. gypgODUCT MATERIAL ar[en b cha gl e od a fected premises n ny move from the the end of paragraph ( i) to a semi. Oro p LI nsing for Certain Medical colon, and adding a new paragraph quarantined area Ir it has been deter. Uses (ex3 x mil) to read as follows: mined by a State or Veterinary Ser-vices Inspector tb rough epidemiolog. AGENCY: U.S. Nuclear Regulatory 35.100 lkhedule A--Groupe of medkal leal investigation t ist she is not an af. Commission. M d fected or exposed a nimal and she is ac. AC' TION: Effective rule. companied by a ceiIificate;
SUMMARY
- The Nuclear Regulatory * * * * *
(7) A mare or stallion bred on a Commission (NHC) is amending its (c) Group 111. Use of generators and premises which is tot a known infect. regulations to add a new reagent kit to reagent kits for the preparation and ed premises may tr ove from a quaran. I use of raJiopharmaceuticals contain. drugs ear nt kita p ed ing Woduct maMal for cedain & Lined area lf it has been determined by The amendment adds to these lista a agn stic uses. a State or Veterin. ry Services Inspec- kit for preparation of technetium-99m tor through epider tiological investiga- labeled gluceptate sodlum for brain , , , , , tion that the anim 61 la not an affected and renal perfusion imaging. This (3) Reagent kits for preparation of acti n is being taken by NitC because or exponed animal Lnd if the animal is of the recent Food and Drug Adminia. technetium-99m labeled, accompanied by a (rrtificate; or tration approval of this reagent kit. (8) A horse whic i is not an affected EFFEC'TIVE DATE: June 16,1978.
- or exposed anima may move inter.
FOR FURTIIER INFORMATION (xti) Oluceptate sodium for brain state through the guarantined area if CONTACT: and renal perfusion imaging. mecompanied by a certificate and if Patricia C. Vacca, Division of Fuel (8ces. st.1 sib. Pub. I as-703, as amended, moved through sur i area without con. Cycle and Material Safety, Office nf as stat. 935,94s (42 tLB C. 2111. 2201); sec. tact with other an mals while in such Nuclear Material Safety and Safe. 201. Iw L e3-438, as amended, as 8 tat. area. guards, U.8. Nuclear Regulatory 1242 <42 UR C. 584t u Commission. Washington, D.C. Dated at 15ethesda, Md., this 9th day e e e e 20555.301-427-4232. of June 1978. SUPPLEMENTARY INFORMATION: For the Nuclear Regulatory Com-(Bertions 4 7, 23 8 tat 32. as amended, ecc- Notice is hereby stven of the amend mLuton. tions I and 2. 32 Stat 191 792. as amended. ment of the Nuclear Regulatory Com- Lrz V. Oossicx, sections 1-4. 33 stat.1l:64.1265, as amended mission's Rrgulation. "lluman Uses of Execultte ihreeforfor Operraf tons. (21 UR C. til.113. l'6. 117. 120. 121. 133- Hyproduct Material." 10 CFIt Part 35. Int Doc.18-16753 Piled 6-15-7s. a 45 aml 126). 37 FTt 18464. 284 7. 38 Mt 19141.) Section 35.100 of 10 CFR Part 35 lista groups of medical uses of radioiso-In view of the na lure of the disease topes that have similar requirements [1505-01] and circumstances under which it is for user training and expertence, fa. dinneminated and I ) order to prevent cilities and equipment, and radiation Title 12-Sonks and Banking the int %te spresil of the disease,it safety procedures. The notice of proposed rulemaking CHAPTER lil-FECERAL DEPOSIT is necc sary that ttis amended regula. tion be placed in < ffect immediately. N,7g,' "" U" on J ary 21,1974 Therefore, the arr rndment must be 2384), stated that the groups of 11 9$ INSURANCE CC RPORATION SusO4 APT 98 6-801 CLATIOM3 ANO made effective imn ediately to accom. censed uses would be amended from STATEMENTS of 04 NetAt POUCY I to add plish its purpose in .he public interest, t and good cause la found for making and uses as they are developed. The the amendment eff etive less than 30 Food and Drug Administration (FDA) Meninwm Rotes of nterest Payable days after publicat on in the ProtaAl. has recently approved a "New Drug '" U** O 'Pg nacistan. Application" for technetium-99m as gluceptate sodlum for brain and renal Correc, non Done at Washins' on. D.C., this 14th perfusion imaging and this procedure day of June 1918. is hereby added to Group 111. In FR Doc.15488 i .ppearing at page Beesume these amendments relate 24269 of the tasue foi Monday, June 6, Nots-The Animal J.d Plant IIcalth In. solely to procedural matters, the Com. 1978, the last foott ute in the third t10 should read, spection ServW has kiermined that this mlaiton has found that good cause column on page 24 document doce not cor Lain a majur proposal entsta for omitting notice of proposed "* Funds deposited n IRA or Keogh reaultins preparsuo< of an Innauon rulemaking and public procedure Plan accounts prior to June 1,1978 Impact Statement uri ter Esecuthe Order thereon, as unnecessary, 8tnce the wit! be eligible to enn n up to 8 percent 18821 and OMD Ctreul,r A-101. amendment telleves licensees from re. per annum so long am the deposit has a Non,in t. Mgvga, strictions under regulations currently maturity of at least three years from in cf feet. it may become effective with. the original date of d rpostt. The matu. Acting Depulp Admintsfrutor's. out the customary 30-day notice. rity of IRA and Ket sh Plan deposita Fe W W e M ee Pursuant to the Atomic Energ7 Act may be extended . or this purpose (F14 Doc. 7818458 Fttd 418-18. 8 46 mm) of 1954, as amended, the Energy Reor. without payment o ; the premature M006At Stellitt, VOL. 43, NO, llF-ftIDAY, JUNE le, jfr$ i 31:CA16nto GXm(00))
j
$ a V 27995 l
i Paoeosso Rutas . e such licensees to confirm the removal that adoption of the following amend-In considerattor of the foregoing, it of the implanta at the end of the ' ment to 10 CFR Part 35 ts conteraplat. b proposed to amnd 7 CFR Part 1433 treatment by (1) a source count and ed. as f llows: (2) a radiation survey of the patient. In 10 CFR Part 35, 3 35.14(bM5xvil) Peyment Preyme fue Fallure to account for all implanta af, is amended to read as follows:e *
*/, ' %e Seppe rt the conctualon of patient treatment 19n Crop N : = and Segeesene 3 33.14 Specifle licenses for certain groupe has resulted in some instances of un- of medical uses of byproduct atterial
- 1. 13y revising parastaph (4) of necessary radiation exposure to pa-l1435.3 to read as follows, tients and members of the general . . . .
public. i 1833.3 Definitions . DATES: Comment period expires (b) Any licensee who is authortred to (33.1977 crop" ' *
- August 14.1978. use byproduct material pursuant to l one or more rroups in (( 33.14(a) and I sucar Producing l*ca and Iterecatine ADDRESSES: Written comments or 35.100 is subject to the following con-
# suggestions for consideration in con- ditions:
Susarbeets: nection with the proposed amendment Muthern Califo: '.ta. March to Septem- should be submitted to the Secretary * * * *
- of the Commission. U S. Nuclear Reg.
wtand area. April to August ulatory Commission. Washington, D.C. (5) For Group VI any licensee who Art,s g 77, 20555, Attention: Docketing and Serv- possesses and uses sources or dQ
- 2. By revising paragraph (a) of ice Branch. Coples of commenta re. containing byproduct material shall.
cetved may be examined at the Com-l 1435.17 to read a. follows: mission's Public Document Room at * * * *
- 1717 II 8treet NW., Washington. D.C.
l 1133.17 Definition' e (vil) Assure that patienta treated ta)"1977erop"' FOR FURTHER INFORMATION with cobalt-60, cesium-137 or iridium-sugar Prmisetna , rea and /Isrmissa CONTACT: 192 implants remain hospitalized until p,, Iod Edward Podolak. Office of Stand- a source count and a radiation survey ards Development. U.S. Nuclear Reg- of the patient confirm that all im-Susarbeets; ulatory Commission. Washington
- plants have been removed.
Southern Califor ila, March to Septem* D.C. 20$55, phone: 301-443-6910. , ber 1971. * * *
- Arts.ons, lowland
- area. Aptti to August SUPPLEMENTARY INFORMATION:
1977. NRC regulations in 13514(bx 5xvil) re- (sec.161. Pub. L 83-703, 68 Stat. 948 (42 quire Group VI licensees' to assure USC. 2?ott Sec. 201 Pub. L 93-438, 88 Subtert-Prke lopper teen Progrom fee 1973 that patients treated with cobalt-60* stat.1243 (42 UaC. 5841).) Crep 5=gerbee .. uk.... c. dm... f. c. eM === ;;;g,;;= quest for commeno ing. Medu i ther py the..ees six groups. each stoup havins almtlar re. iconomic Regula-ornnents f r user tramms and espert-
SUMMARY
- The AGENCY: US Nuclear Regulatory en" f acM" *"d Nubment. and radL* Mon tory Administration (ERA) of the De.
Comminton ( N RC,* safety procedurce. Groups t.11 and !!! are partment of Energy (DOE) announces hats of radiopharmaceuticats for dtaanostic the availability of r n environmental ACTION. Proposed rule assessment (EA) on the pending pro-k'[o$Y$$ 'c',7 tlc $1s orYher pSte p e- posal to exempt m' tor gasollne from HUMMARY: Certain NRC licensees are authorized to treat patients alth durn, and Group vi is a itst of radioactae the Mandatory Pet roleum A!!xation implants incorporting radioacthe ma- medical deuces for both diagnostic and and Price Regul Ltions. The EA tertal. NRC is conMdering requiring therapeutic procedures, flott At t1011118, VOL. 43. NO.123-W10Nt10AY, JUNG 20, 1978
~ - - _ _ _ _ .
. s 29297 proposedrules Dvs secten of the FEDER At REGl$ff R contains notices to the public of the proposed issuance of rules and regvlahons. The purpose of these not ces is to gse interested persons on opportunety to parbcipate in the rule mohing pnor to the odophon of the finot rules.
health) personnel were adequately the patient is a minor; or the patient is [7590-01] trained in the safe use of radioactive unconscious and incapable of compre-NUCLEAR REGULATORY materials. Because 5 years have hending the information. The licensee COMMIS$loN elapsed since the AEC requirement would have the discretion or reporting was proposed, it is being withdrawn either to the patient or to the pa- [10 OR Port 35) and a new NRC proposed mindmmis- tient's responsible relative. The record tration recordkeeping and reporting or report which would be supp!!ed to HUMAN U5t$ Of BYPRODUCT MATIRIAt requirement,10 CFR $ 35.33. is being NRC would contain a brief description Mhedministration Reporting Require **a's offered for public comment. The NRC of the event, the effect on the patient, AGENCY: Nuclear Regulatory Com, proposed rule reflects the public com- and the action taken to prevent recur. rence. The names of individuals would menta on the AEC proposal. mission. One purpose of the miwiminhtra- be maintained in the licensee's record ACTION: Proposed rule, tion reporting requirements is to allow but not reported to the NRC. A copy NRC to investigate the incident: deter- of the report to NRC would be fur-
SUMMARY
- The Nuclear Regulatory mine if there was a violation of NRC nished by the licensee to the patient Commission is considering amendmg regulations; evaluate the corrective or the patient's responsible relative if its regulations to require licensees to action taken by the licensee to mini- either had been notified previously, (1) keep records of all misadministra- mize the chance of recurrence: and, if An example of the follow up action tions of radioactive material or radi. there is a possibility of other licensees NRC might take upon receipt of a mis-ation from radioactive material, and making the same error, to allow NRC administration report was the NRC in-(2) promptly report potentially dan. to begin generic corrective action vestigation of an incident were 400 pa-gerous misadministrations to the which, as a minimum, would inform tients treated for cancer with a cobalt-NRC, to the patient's referring physi, other licensees of the potential prob- 60 teletherapy unit received radiation clan. and to the patient or the pa- Iem. Another purpose is to inform the doses that exceeded the prescribed tient's responsible relative. patient or the patient's responsible doses by as much as 41 percent. This DATES: Comment period expires Oc , relative so that corrective action can incident occurred because the radi-tober 5,1978. be taken. On this point, the Commis- ation dose rate from the teletherapy sion has expressed concern about the unit had not been properly deter-ADDRESSES: Written comments or possibility of undue intrusion into the mined. Soon after its investigation, suggestions for consideration in con- physician patient relationship. Conse- NRC acted to ensure that all telether-nection with the proposed amendment quently, the Commission asks that apy units licensed by it were properly should be submitted to the Secretary commentors particularly focus on calibrated. NRC also published in the of the Commission. U.S. Nuclear Reg. those portions of the proposed amend- FEDERA:. RectsTrn (42 FR 35743) a pro-ulatory Commission. Washington, D.C. ments which deal with the manner in posed amendment to $35.13 requiring 20555, Attention: Docketing and Serv
- which referring physicians and their teletherapy licensees routinely to cali-Ice Branch. Copies of comments re* patients are informed of misadminis- brate and check their teletherapy de-ceived may be examined at the Com. trations- vices. The teletherapy calibration pro-mission's Public Document Room at Specifically, NRC's proposed 135.33 posal also included a specific misad-1717 H Street NW., Washington, D.C. would require licensees to maintain for ministration reporting requirement
-inspection by the Commission, records that would be replaced by i35.33 (a FOR FURTHER INFORMATION of all misadministrations of more general proposal). Comments re-CONTAC*.r: radiopharmaceuticals or radiation ceived in response to the earl!er te-Edward Podolak. Office of Stand- from teletherapy and brachytherapy letherapy misadministration reporting 1 nrds Development U.S. Nuclear Reg. sources. Licensees would also be re- requirament will be considered in con- j 11atory Commission, Washington, quired to rep' ort promptly all misad- function with the proposed rulemak-D.C. 20555, phone 301-443-6910. ministrations that involve a therapy ing.
procedure and those diagnostic misad- In this newly proposed rule, SUPPLEMENTARY INFORMATION: ministrations that could cause a clini- $ 35.33(f) (4) and (5) define misadmin-Following its organization under the cally detectable adverse effect on the istrations in part as administrations Energy Reorganization Act of 1974 patient: (1) To the NRC. (2) to the pa- differing from the total prescribed (Pub. L 93-438), NRC, with a view to tient's referring physician. and (3) to dose or exposure by more than 10 per-possible changes, began reviewing its the patient or the patient's responsi- cent for therapeutic procedures or 20 regulations and procedures about 11* ble relative, unless the referring physi- percent from diagnostic procedures. censing and regulation of nuclear f a- clan personally informs the licensee These limits should not be viewed as cilities and materials originally pro' that in his medical judgment telling the normal calibration limits for these mulgated b), the Atomic Energy Com* the patient or the patient's responst- procedures but rather the points mission ( AEC). ble relative would be harmful to one where an error obviously has occurred. On March 9.1973, the AEC pub- or the other, respectively. The narrower tolerance for the thera-lished a proposed rule in the FEDERAt. It is expected that the licensee peutic procedures recognizes the Racistra (38 FR 6399) that would would report to the patient's responst- greater risk to the patient from thera-have required licensees to report to ble relative rather than the patient peutic misadministrations. Pursuant to the Atomic Energy Act the AEC and to the patient all misad- when, for example, the referring phy-ministrations of byproduct material sician tells the licensee that in his of 1954, as amended. the Energy Reor-and also would have required licensees medical judgment informing the pa- ganization Act of 1974, as amended, to determine that paramedical (allied tient would be harmful to the patient; and section 553 of title 5 of the United PEDERAt REGISTER, VOL 43, WO.1314810AY, JULY y,1978
~
29298 PaorosEO RULES States Code, notice is hereby given the patient's responsible relative); a Recommendatiois of the Commis-that the 1973 AEC proposed rule (38 brief description of the event; the sion regarding th a proposals will be FR 6399) is withdrawn and adoption effect on the patient; and the action pub!!shed after LII comments and of the following new amendments to taken to prevent recurrence. statements are cor sidered. 10 CFR Part 35 is contemplated. (f) For this section, misadministra-A C " A new 135.33 is added to 10 CFR Part tion means the administration of: ge gs at gasol 35 to read as follows: (1) A radiopharmaceutical or radi. August 1,1978;10 rosene base jet fuel,
$ 35.33 Records and reports of misadmin- ation from a source other than the August 3,1978. Fate for requests to
" participate in publ e hearings: July 27,
- 2) d pharmaceutical or radi-
, (a) When a misadministration in- ation to the wrong patient; 0'
j volves either a diagnostic procedure (3) A radiopharmaceutical or radi- ADDRESSES:
; that could cause a clinically detectable ation by a route of admmistration adverse effect or therapy procedure, other than that intended by the pre- Wam hm di o ery t at he a i tr t o scribing physician; Federal Energy tegulatory Commis-is likely to have occurred, the licensee (4) A diagnostic dose of a radiophar. sion, 825 North C ipitol Street, W3.sh-shall notify by telephone:
maceutical differing from the pre- Ington, D.C. 20426 (1) The appropriate NRC Regional ribed dose by more than 20 percent; Office luted in appendix D of part 20 (5) A therapeutic dose of a radio-of this chapter: Kenneth F. Plu nb. Secretary, Fed-(2) The patient's referring physician; pharmaceutical or exposure from a r2* eral Energy Reg 1 iatory Commission, and diation source such that the total d25 North Capitol Street Washington, (3) The patient or the patient's re. treatment dose or exposure differs D.C. 20426. sporuible relative, unless the referring from the prescribed dose or exposure physician personally informs the 11 by more than 10 percent. R EQUEsT i To SPEAK censee the in his medical judgment (g) Aside from the notification re-telling the patient or the patient's re. quirement, nothing in this section Robert L. Bau: 1 Deputy General sponsible relative would be harmful to shall affect any rights or duties of 11 Counsel Federal Energy Regulatory Commission,825 7 arth Capitol Street, one or the other, respectively. censees and physicians in relation to Washington, D.C. :0426. (b) If the referring physician, or tne each other, patients or responsible rel-patient's responsible relative is un. atives. FOR FURTHEI INFORMATION available within 24 hours, the licensee (Secs. 81.161 P'ab. L 83-703, 63 Stat. 935 CONTACT: shall make the notification under 948 (42 U.S.C. 2111, 2201t Sec. 201, Pub. L Robert L. Bau-1 Deputy General 93-438,88 stat.1242 (42 U.S.C. 5841).) paragraphs (aX2) or (ax3) of this sec. Counsel. Federa Energy Regulatory tion as soon as practicable after that Dated at Wuhington, D.C., this
- Co'mmission. 8 5 North Capitol person becomes available. Attempts to 30th day of June 1978. Street. Washing' im, D C. 20426; 202-For The Nuclear Regulatory Com. 275-4333.
ti nt , es ible re ti hall no defer needed medical care for the pa- mission. SUPPLEMENTA0 Y INFORMATION: SAutTI. J. Cutt.K. On October 1,19 7, the Department tient"Within (c) 15 days after the licens. Secretary of the Commission. of Energy Organ. 'ation Act, Pub. L. ee's discovery that the misadministra- f FR Doc. 78-18735 Fi!ed 7-6-78; 815 am! 95-91. (the DOE Act) became effec-tion is likely to have occurred, the !!- tive. That act es ablished a Depart-censee shall make a written report to [6740-02] ment of Energy 9 ithin the executive the NRC Regional Office initially tele-DEPARTMEN' ' OF ENERGY branch. In additiol i to transferring the phoned, and furnish a copy of the functions of the / M.ministrator of the report to the patient or the patient's Federal Energy Eq uietory Commission Federal Energy A- mmistration to the responsible relative if either has been Secretary of th e Department of provfously notified under paragraph M CM hru 2424210 Energy, the DOE Act created within (aH3) of this section. tDocket N x EA78-21 the Department a i independent colle. (d) The written report made under gial body; viz, the 'ederal Energy Reg-paragraph (c) of this section shall in. EXEMPTION OF AVIA MON CA10t!NE AND ulatory Commissio T (the Commission). KEROSENE-8ASE JET FUEL FROM THE ALLO-clude the licensee's name; a brief de. Included in the authority vested in scription of the event; the effect on CAtlON AND PAlCE . EGULAtlONS the Commission bu the DOE Act is the the patient: the action taken to pre
- jurisdiction, in t ction 402(cx 1), to Hearing end Opportur ty for PubH4 Comment vent recurrence; and whether the 11- consider certain p- opmais by the Sec-censee informed the patient or the pa- Jet.y 3,1978. retary to amend .he regulation pre-tient's responsible relative, and if not. AGENCY: Federal Energy Regulatory scribed under act' 'n 4(a) of the Emer-why not. However, the report should Commission. gency Petroleum Allocation Act of not include the names of others in- ACTION: Solleitat 1973. This regulati :n provides for con-volved in the misadministration, such on ofhearing.
public public com- trolling the price and allocation of as the patient, physicians, and ailled ment and notice of crude oil and r troleum products. health personnel.
SUMMARY
- The li ederal Energy Reg. Amendments whic i would exempt pe-(e) Each licensee shall maintain for ulatory Cc m mi3s ?n invites public troleum products rom this regulation 5 years for Commission inspection rec- comment on propo ;ed amendments to are required to b4 transmitted to and ords of all misadministrations of exempt aviation i uoline and kero. reviewed by each ! >use of Congress.
radlopharmaceuticals or radiation sene-base jet fuel # om mandatory pe- The DOE Act pr wides that Commis-from telet herapy or brachytherapy troleum allocation and price regula- slon con.itderation of these proposals tources. These records shall contain tions. The proposei amendmeats were be subject to pro edures set forth in the names of eseryone involved in the is. sued by the Ec< lnomic Regulatory section 404 of tlt, act. In accordance event (including the licensee, the au- Administration ani . were transmitted with those proce. 1res the Commis-thort/ed userts), a!!!ed health person- to the Commisstor for its considera. sion will, after re ching public com- , net, the patient's referrin,t physictan, tion by the Secret try of the Depart- ment and holding warmes on the pro-the patient, and, w here appropriate, ment of Energy on ane 22,1978. posals, coruult wit J t he Secretary, and FEDER AL REGl1TER, VOL. 43, NO.131-FRIDAY, JULY 7,1978 i bL
i RULES ANO REGULATIONS 37421 Itself. The same ressons that support unless %dvised to the contra.ry, accordmgly (Sees 81.161b. Pub L 83-703, as amended. n bar on such filing with the Commis- reDects inclusion of the 45-day period shich 68 Stat. 935. 948 (42 U.S C. 2111. 2201 s. see sion also support a irohibition against that statute n!!os s for such reues (44 201. Pub 1. 93-438. as amended. 88 Stat. filings with the sut ordinate adjudica Uac. 3512< c x 2 n. 1242 4 42 UAC. 5841 u ,
.i t:ry bodies in the Commission. The FOR PURTHER INFORMATION Dated at Bethesda. Md. this 8th day Commission has de ided to amend its CONTA("I': of August 1978.
regulations accordir gly. Edward Podolak. Office of Stand- For the Nuclear Regulatory Com-EFFECTIVE DATE August 23,1978- ards Development. U.S. Nuclear Reg- mission. INFORMATION ulatory Commission. Washington, Ltr V. Oossicx FOR PURTIIER D.C. 20555, phone 301-443-5946. CONTACT: Executit'e Direct'or Stephen S. Ostra :h. Esq., Office of SUPPLEMENTARY INFORMATION: \ for Operations. 'I the General Cou sel, U.S. Nuclear Presently, applications for the medical IFr .' 23340 Filed 8-22-78. 8.45 aml Regulatory Com nission, Washing. use of byproduct material are filed on ton, D.C. 20555, 21 2-634-3224. the general application form AEC-313 with the aid of a medical licensing SUPPLEMENTAR' ' INFORMATION: guide (NUREG-0338, Rev.1) which re- $90-01] Because this ame. idment relates to quests information necessary for and ART 73-PHYSICdLL PROTECTION OF mitters of interns I agency practice, specific to the medical application. PLANTS ANil MATERIALS general notice of pl oposed rulemaking Form AEC-313 does not have enough is unnecessary. space and does not specifically address Security Person tel Qualification Pursuant to se< tion 161 of the much of the information requested in . Atomic Energy Act of 1954. 42 U.S.C. "'" 8 " " **"' ' the medical licensing guide. A new l. 2201 and to 5 U.f C. 552b(g) and 5 form NRC-313M has been deseloped AGENCY: U.S. Fuclear Regulatory U.S.C. 553, the nexl to last sentence of specifically for the medical applica- Commission. 10 CFR 9.103 is amtnded to read; tion. Form NRC-313M does not change the substantive requirements ACTION: Final ru1'~
$ 9.103 Geneg proc iions. that must be met by applicants for
SUMMARY
- On July 5. 1977, the
* *
- Such state nents may not be medical licenses. The information re- Commission publisbed for public com-pleaded. cited, or 'elied upon before quired on the new form is the same as ment proposed anendments to the the Commission or in any proceeding that currently identified in the medi- Commission's reg'llations to impose under part 2 of th =se regulations (10 cal licensing guide. Ilowever, because upgraded guard qudification, training.
CFR part 2) except as the Commission the new form NRC-313M is tailored to and equipping regtfrements for securi-may direct. the medical licensing guide, it is easier ty personnel proti eting against theft Dated at Wash ngton, D.C., this for the licensee to use and, on a trial of special nuclear :naterials and indus-17th day of August l978. basis. has resulted in less correspon- trial sabotage of luclear facilities or dence between NRC and the appu- nuclear shipnaents
' For the Comndssi >n. cants regarding deficiencies in their In response to p iblic comments, the S iwurt. J. Curt.K. apphcations, training and qual fications section of Secretary o' the Cbmmission. Form NRC-313M and the memeal 11- the proposed ami ndments has been (FR . 78-23588 Pi ed 8-22-78. 8.45 aml censing guide are available from the extensively revised to ppecify perform-Radioisotopes Licensing Branch, Divi- ance oriented regt irements instead of sion of Fleed Cycle and Material the detailed train ng requirements as Safety. OfDm of Nuclear Material originauy propose 3 on July 5.1977.
(75 -01] Safety and Safeguards, U.S. Nuclear The performance oriented require. PART 35-HUMAN USES OF Regulatory Commission, Washington, ments give licensies flexibility in se-D.C. 20555. lecting and develcping the most cost-BYPRODUCT MATERIAL Because this notice relates to mat- effective training programs to meet Application Form for Meteriols ters of agency management and proce- site specific needs The Nuclear Regu-dure, general notice of proposed rule- latory Commissioi. now is publishing License-Medical making and public procedure thereon these revised arrendments in final AGENGY: U.S. Nuclear Regulatory are unnecessary and the amendment form. Commission (NRC), can be effective 75 days after publica- Concurrent with publication of these tion. amendments, the NRC is issuing for ANE Nal mit Pursuant to the Atomic Energy Act public comment iutdance documents CUMMARY: NRC is amending its res- of 1954, as amended. the Energy Reor- to assist the licersee in the develop-ulations to require use of a new for:n gamization Act of 1974, as amended ment of security personnel training NRC-313M., " Applications for Materi- and sections 552 and 553 of title 5 of and qualifications plans required by als License-Medical". The new form the United States Code, the following the amendments. ' te effective date of is easier to fill out than the one it re- amendments to Title 10. Chapter I, the revised requir 'ments has been set places, and, on a trial baals, has result- Code of Federal Regulations. Part 35 to permit pubHc e< 'mment on the guld. ed in reduced correspondence between are published as a document subject to ance and its issua lee in final form at t NRC and the applicants regarding de- codification. the time the requ rements become ef-ficiencies in their applications. A new section i 35.4 is added which fective. EFFEC'ITVE DATE: November 6. reads as fouows: EFFECTIVE DA'IE: October 23,1978. I I 33.4 Application form for specific h- Nott.-The Nuclesr Regulatory Commis-Nots.-The Nuclear Regulatory Commis- eensea. snon has submitted his rule to the Comp-ston has submitted this rule to the Comp. e r O m raj kr Ms of its reporus troller General for such review as may be Applications for specific licenses for requirements under the Federal Reports } appropriate under the Pederal Reports Act, human use under H 35.11. 35.12. and Act, as amended. 4. O s C. 35t2. The date ' as amended, 44 U.8 C. 3512. The date on 35.13 shall be filed on form NRC- on mhich the report na requirement of the C hich the reporting trecordkeepinal re. 313M. " Application for Materials Li- rule becomes effecthr. unless advised to the . qutrement of this rule becomes effecuve, cense-Medical." contrary, includes a , 45. day period th6ch I PEDERAL REGISTER, VOt. 43. NO.164-WE064E50AY, AUGUlf 23, 1978
I a 4
/
- RULES AND RE2ULATIONS 39747 Agriculture Roon 6316. Washington, in cases where con ' parable systems are driegation of authd it) bs the Acist am D.C. 20250_ All w ritten comments not available or the user rates from secretary or Agricult are for itural th WW
% made pursuant to this notice will be the comparable s3 stems appear to be rnenL7 crn 170a ata' table for pub!m inspection at the too high for the tverage user of the Dated: August 2f .1978. address given abov applicant, and the median income In JAME: E. THoWToN. FOR F U R Ti!El INFORMATION , 'the applicant sert;ce area is less than A ssocta <c Admen tstrator. CONTACT. $4.000. In those cans u here it is deter. I mined that such on exception should farmers #o7 ;e Adman ntration. Mr. Allen I. Turpbull. 202-447-5717. be considered, the FmH A State Direc- IFR Doc. 78-25t19 iled 9 6-78. B 45 arn) SUPPLEMENTARY INFORM ATION: tor will submit infprmation to the Na-Section 1823.472 (td. (b x1), and (bH 3) tional Office cone rning health condi-of subpart P of ptrt 1823 of Chapter tions of the area median incone of [7590-01] the service area, he user rates and XVIII, Title 7, code of Federal Regu. lations are amended. The purpose of median income ofl other like or most Title 10-Energy these amendments is to provide grant , similar communities in the region, em-benefits to eligible users in justifiable ployment conditlocs, and any other in- CHAPTER l-NUCLEAR REGULATORY cases for areas of extremely low formation to justify the recommenda- COMMISSION income when it is necessary to meet tions for the excepition. the needs of a paiticular community. (1) Ordinarily, an applicant will be PART 35-HUMAN LISES OF It is the policy of this Department considered for grant assistance only BYPRODUCT MATERIAL that rules relating to public property, when the debt service portion of the loans, grants, berefits, or contracts average user rate for either water or Group Licens,mg for Certa,m Medisal shall be published for comment not. waste service, for only those users in I withstanding the exemption in 5 the applicant service area, exceeds the Uses f U.S.C. 553 with reupert to such rules. following percentages of median in- AGENCY: U.S. Nuclear Regulatory
, These amendmenta however, are not comes. (
(1) .75 percent t when the me'dian Commission. i published for proposed rulemaking ACTION: Fmal rule. since the purpose )f the change is to income is under $6!000. provide necessary prant benefits to ell. (ii) 1.00 percent: when the median
SUMMARY
- The Nuclear Regulatory gible users and any delay would be income is $6,00010 $10,000. 6 Commission (NRC) is amending its contrary to the put lic interest.110wev. ( 111 ) 1.25 percent when the median regulations to add a new procedure to cr, the Agency is laterested in receiv. Income is over $10.)00. Its lists of authorized radioactive ing public comments at the address Median income will be determined in drugs, reagent kits and procedures.
given abovt accordance with paragraph (b)(4) of The amendment adds to these lists the Accordingly, IIf 23.472 (b), (b X 1 ), this section. Excert as provided for in use of technetium 99m labeled human and (bH3) of subpart P of part 1823 paragraphs (b) and (bx3) of this sec- serum albumin microspheres for teno. are amended and re ad as follows: tion the grant wil be limited to an graphy. This action is being taken by amount necessary to reduce the debt NRC because of the recent Food and g 1823.872 A pplication preening. service portion of aser cost to the ap- Drug Administration approval of this plicable percent h vel listed above. If radiopharmaceutical for venography. e the median incon.e is not available, EFFECTIVE DATE: September 7. (b) Determining Me need for derel- the average income may be used. This 1978' opment grartt. Grants will be used for procedure shall nc t be used to result
- water and waste dimosal projects serv- in a rate below thF t deemed to be rea. FOR FURTHER INFORMATION ing the most finane ally needy commu- sonable as defined in paragraph (b) of CONTACT:
e nities to reduce user rates to a reason- this section. Howe rer, an exception to Patricia C. Vacca. Division of Fuel 5 able level for f armers, ranchers and the reasonable usor rate may be au' Cycle and Material Safety. Office of rural residents. Other rural users thorized by the Pn HA National Office Nuclear Materit! Safety and Safe-l whose needs are met or, if there is no in accordance with paragraph (b) of guards. U.S. Nuclear Regulatory i meter. could be m< t by a single rest- this section* Commission, Washington. D.C., i dential. size water meter may also De 20555,301-427-4232. i
. considered eligible For example, a e e > . .
i user on a waste sys em may be consid. SUPPLEMENTARY INFORMATION: ered for a grant whFn the water needs (3) If, after appl 3 ing the formula de- Notice is hereby given of the amend. of the waste user are met or could be scribed in paragrarh (bX1) of this sec- ment of the Nuclear Regulatory Com-3 met by such resUential-size meter. tion. FmHA determines that a reason
- mission's Regulation. "liuman Uses of
- This method of coriputing grants will able user rate has not been achieved Byproduct Material" 10 CFR Part 35.
due to unusually algh operation and Section 35.100 of 10 CFR Part 35
= be used for all wate and waste dispos- maintenance costn construction or lists groups of medical uses of radioiso-s al projects. Reasons ble user rate is de-1 fined as that which is not less than ex- water acquisWon oosts, or other fac* topes that have similar requirements tors, FmHA may p oceed with a grant for user training and experience, fa-j l 1 sting prevailing ral es in communities
+ being served by an rstablished system in an amount necessary to reduce the cilities and equ!pment, and radiation
$ constructed at simil tr user cost having user cost to not below a reasonable safety procedures.
level as defined iii paragraph (b) of The notice of proposed rulemaking f similar economic conditions. User this section. liowe1 er, an exception to that was published in the FEDERAL I rates shall include i'harges, taxes, and the reasonable ust r rate may be au* Rrcistra on January 21,1974 (39 FH assessments attributable to the pro)-
& ect. An exception to the reasonable thorized by FmHA National Office in 2384) stated that the groups of 11-I user rate may be granted by the ace rdance with ps ragraph (b) of this censed uses would be amended from section. time to time to add new FmHA National O fice in justifiable (j cases for areas ( f extremely low radiopharmaceuticals, sources. desices ! income when it is accessary to meet and uses as they are developed. The the needs of a parilcular community. (7 US C.1989. deler ition of authority by Food and Drug Administration (FDA)
Such an exception will be considered the Betretary of Agriculture. 7. CFR 2.23. has recently approved a supplement to PDERAt RfG4 STER, VOL. 43, NO.114-TMUR$0AY, SEMIMSER 7,1978 s
~] \
e 39748 RULES AND REGULATIONS "New Drug Application" for techne- (Docket No. 78-WF,- '0-AD. Amdt.39-3295] amendment effictive in less than 30 tium-99m as human serum albumin days. microspheres for venography and this PART 39-Al.tWORTHINf55 Aporrros or Tus Amoum procedure is hereby added to Group DIRECTIVH
!!I. A n y, p 2rsuant to N auh ity delegated to 'ne by the Administra-Decause these amendments relate PiPer Aeroster Wdel 600' 601' ond solely to procedural matters, the Com. 60lP Airplanes tor (14 CFR 1119). 939.13 of the Fed.
eral Aviation Regulation (14 CFR mission has found that good cause AGENCY: Federa: Aviation Adminis.. 39.13) is amended, by adding the fol-exists for omitting notice of proposed tration (FAA) DOT . lowing new airworthiness directive: rulemaking and public procedure ACTION: Final rule. Preta ArnosTAn: /polies to Piper Aerostar thereon, as unnece.isary. Since the ; Model 600. 601 and 601P airplanes certt-
SUMMARY
- An einergency airworthi- ficated in all $tesones, senal numbers amendment relieves licensees from re- ness directive ( AD) was issued by the 150 through 520.
strictions under regulations currently Federal Aviation Administration on Comphance required as indicated. To pre-in effect, it may become effective with- July 7,1978 as a result of abnormal vent reversed readings of left and right wing out the customary 30-day notice. fuel quantity indleating system oper- tankf 1qu it o lish the f lo's ng Pursuant to the Atomic Energy Act ation on certain Ptper Model 600 the eflrctive date of this AD. unless already of 1954, as amended, the Energy Reor. Series Airplanes. (This AD required accomphshed, with LH and RH wing tanks ganization Act of 1974 as amended. test, and repair if becessary to insure at least 50". deplettd from tank capacity-
. that the fuel atlantity information (1) Read and redord fuel quantity indica.
and sections 552 and 553 of title 5 of presenten to the pilot reflects the fuel tion for Lif and R8 wing fuel tanks. the United States Code, the following quantity in the appropriate fuel tank. i2) Add to gallors of fuel to one wing tank amendments to Title 10 Chapter I. Y This publication ylpersedes that AD Oy3iRead and rec ord fuel quantity for each Code of Federal Regulations. Part 35 in that additional rework information wing tank. are published as a document subject to is pr vided and sa ttch identification is (4) Determine that the added fuel regis-returned to standa{d. tos on the correct wing tank fuel quantity I tuficator selector 5osition,
- 1. Paragraph (ex3)(v) of g 35.100 is DATES: Effective date-September 13 (5) If the correc' wing tank fuel quantity amended to read as follows: 1978. Initial combliance-Within 10 se lector position legisters the added fuel, hours time in sertice after effective ti+ system is normal and no further action j31100 Schedule Miroups of medical date of this AD' I8 QUI'*d ""d '
' uses of byproduct material. a b) If the approg "8 AD' riate wi ng tank fuel indi-
. . . . . FOR PURTIfER INFORMATION 2 ded el th > e ma Ym ro ry CONTACT: wired or the selec$r may be improperly m.
sc) Group III. Use of generators and Jerry J. Presba. Executive Secretary. dcxed. In this esent, prior to further flight; reagent kits for the preparation and C "##' th' "'I 4"*""'" I"dI#*""" Altw orthiness Directive Review " use of radiopharmaceuticals contain- Doard. Federal Akiation Administra. ing byproduct material for certain di- d o proper tch a at o tion. Western Region. P.O. DoX (c) Within 10 h<urs time in service after agnostic uses. 92007. Worldway Postal Center. Los the effective date pf this AD. on those air-Angeles. Calif. 90009, telephone: planes with the fiki quantity indicating se-213-536-6351. lector switch relateled as an intenm solu-(3) Reagent kits for preparation of tion under (Dx2)(f the origmal message of technetium-99m labeled; SUPPLEMENTARY INFORMATION: July 7.1978. corredt the fuel quantity indi-This amendment st.persedes a current- h**jf,"n$rd N ^ "
* * * *
- ng ly effective airworthiness directive (d) Special flight permits may be issued in (v) Human serum albumin micros- i AD) dated July 7 1978, issued by alr* &ccordance with F4Rs 21.197 and 21.199 to mail letter to operators of Ptper Aeros- operate aircraft to a base for accomplish.
pheres for lung imaging and veno- tar Model 600 serien airplancs made ef. ment of the repair required by paragraph B graphy; fective immediately upon receipt. That of thi8 AD-(Secs, 81.16tb. Pub. I, 83-703, as amended; AD required a test for reversed read. (e) Equis alent in:pections and repairs may 68 Stat. 935. 948 4 42 U S C. 2111, 2201); sec. Ings of the left hand and right hand be used when approsed by the Chief. Air. craft Engineering Division. FAA Western 201. Pub. !* 93 438, as amended; 88 Stat. wing tank fuel cuantity indicating flegion. 1242(42118 C'5841)'1 Wstem display, and required corrective action. if appropria e. This amendment becomes effective Dated at Bethesda, Md., this 24th September 13.1S78. day of August 1978. After issuing the AD dated July 7 1978 the FAA has received additional (Secs. 313< al. 601. M3. Federal Asiation Act For the Nuclear Regulatory Com* misalon. rework instructiors to correct the N23" 'ecs e e$. artm t f Tr por cause of fuel quantity indicating rever* tion Act (49 U.S C, 1655acD; 14 CFR !!.891 Lir V. Gossicx. sab Weh pophd W o@nal M. gn7,,-The Fe<foral Aviation Administra. Executit e Director for Operations. This addidonal rework information is tion has determin<d that this document is (FR Doc. 78 25074 Filed 9-6 78. 8.45 ami provided in the prrsent AD and the not sf gnificant in arcordance with the crite-provistons for labellng switch positions ria required by Eucutne Order 12n44 and
.# as an interim solu ton have been su. set forth m interm Department of Trans-perseded by actiot requiring correc, portation Guidehn<s.
14910-13l tion of system mall unction and rever. Issued in Los Angeles. Calif., on l sion to standard s Aitch identification. i Titb 14-Aeronautics and Space Since a situation axists that requires August 28,1978. the immediate adortion of this regula. LEM C. D 4tcurniv. CHAPTER l-FEDERAL AVIATION AD* tion, it is found that notice and public Acting Dt rector. l MINISTRATION, DEPARTMENT OF procedure hereon are impracticable FAA Dstern Regtort. TRANSPORTATIO 4 and good cause emts for making this (FR Doc. 78 25 tij Filed 9-6-78. 8.45 am) i FEDERAt REGi$TER, Vot. 43, NO 174-THUS$0AY, SEPitM8tR F,1978 l l
RULES AND RECULATIONS 47975 tion, CCC may takh title to the com. FOR WRTHER INFORMATION Dated: OctobJr 5,1979. Inodity. CONTACT: BIu. DRATrON,
$ 1421.572 Maturity
- Gerald L. Hatton, Divis'on of Rules Assistant Administrator and Records, Office of Administra- for Plant ing and Management.
Rice reserve loans mature and are tion U.S. Nuclear Regulatory Com-due and payable on the earlier of: (1) IFR Doc. 78-292h5 Fued lo-17-78; 8 45 aml The last day of the 36th calendar Inission, Washington, D.C. 20555 telephone 301-492-7086. r (2) t e last day f he t ont Dated at Bethesda, Ma., this 6th day [6712-01-M] following the mont 1 in which the rice of October 1978. ygg, 47_y reserve agreement is approved. For the Nuclear Regulatory Com-ml881 n- l Signed at Washir gton, D.C., on Oc-tober 13.1978. CHAPTKR l-FEDERAL Lzz V. Oossrex, COMMUNICA TIONS COMMIS$10N Executive Directorfor Operations. ec a y. [FR Doc. 78-29337 Pued 10-17-78; 8:45 aml [ Docket No. 20135; RM-1974; RM-26551 tFR Doc. 78-29424 F1 ed 10-17-78; 8.45 aml PART 73-LADIO BROADCAST LERVICES [7590-01-M] Title 40-Protec' ion of Environment PART 74-EXPERIMENTAL, AUXIL-Title ID-Energy lARY, AND %PECIAL BROADCAST, CHAPTER l-l NVIRONMENTAL AND OTHER PROGRAM DISTRIBU. 3 CHAPTER l-NUCLEAR REGULATORY PROTECT N AGENCY TIONAL SER ICES COMMIS510N suaCHAMIR B-. GRAMS AND 07HER Noncommercial Educational FM PART 35-HUMAN USES OF * "'I "* " BYPRODUCT MATERIAL LFRL 989-41 , 'CY: Fe leral Communications PART 13-SUBAGREEMENTS Coinmission. Application Form for Materials l ACTION: Correction. License-Medical Minimum Standards for Procurement
SUMMARY
- "he Commission pub-AGENCY: Nuclear Regulatory Com- Under PA Grants 11shed a Second Report and Order in mission' AGENCY: Erwironmental Protection this docket on September 6,1978. Cer-Agency
- I tain typographical errors in the ACTION: Approval of reporting re- Report and quirement by Comptroller General.
I ACTION: Interun rule, Order which made changes to th e rules regarding ncn-
SUMMARY
- On August 23,1978, the
SUMMARY
- Interim subagreement commercial educational FM stations Nuclear Regulatory Commission pub. regulations concerning minimum have caused some confusion about the lished in the FEDERAL Rectstra a standards for procurement under EPA intent of the regulation in 973.561.
notice of rulemaking, effective Novem, grants were prontulgated by the Env1 This documerg corrects the typo-ber 6,1978, amending its regulation ronmental Protection Agency on Feb. grapt'ical erro: s in the text of the
" Human Uses of Byproduct Material" ruary 8.1977 (42 8089) with an ef, ond Report and Order, FR Doc. 78-to require use of a new form NRC- fective date of I rch 31,1977, which 41-313M, " Application for Materials Li- was subsequently extended to October DATF8: Effect ve on October 13,1978.
cense-Medical". 1,1978 (43 FR 1( 342). This document The notice included the following es the eff ve date ADDRESS: lideral Communications {py nu )een Commeston, Washington, D.C. 20554. standards) of OMB Ctreular A-102. FOR FURTI :ER INFORMATION sion has bmt h r o h C p- EFFECTIVE DATE: February 1,1979. CONTACT: trouer General for such review as may be FOR FURTHE3 INFORMATION Johnathan David, Broadcast appropriate under the Feders) Reporta Act- Bureau, 202-( 32-7792. CONTACT: hi t re r d ep Alexander J. Greene, Director, SUPPLEMENTARY INFORMATION: quirement of this rule becories effective. unless advised to the contrary, accordins!F Granta Administration Division In the matter af changes in the rules (PM-216), Environmental Protection relating to non ommercial educational renects inclusion of the 45-day period FM broadcast stations. Agency, Wash ngton. D.C. 20460, ch t s tu allows for such review 202-755-0850. Released: October 12,1978. Notice is hereby given that the re- By this action, the effective date is 1. On June 7 1978, the Commission changed as follon: adopted a Seco id Report and Order in he 1 av n pprov d by th I. Effective date: "hese interim part 33 docket No. 20735. This document, en-General Accounting Office. subagreement regulations shall acting a nurnter of rule changes af-become effective on February 1,1979, fecting nonecmmercial educational EFFECTIVE DATE- November 6 and shall govern all procurement ac. FM stations, was released by the Com. 1978. The reporting requirement set tions under grant; awarded on or after mission on September 1,1978, and it out in the notice of rulemaking that date. Procui ement actions taken was published in the FEDERAI, RectstrR amending 10 CFR part 35 which was under grants awsrded prior to Febru- on September f.1978 (43 FR 39704). published in the FEDERAI. Rectstra on ary 1,1979, are st;bject to these regula- 2. Unfortunstely, because of typo-August 23,1978 (43 FR 37421) has tions if the grant (1) includes a special graphierl erro 1 in the Report and been approved by the U.S. General Ae- condition requirlng compliance with Order, confus on arose about the counting Office under No. B-180225 40 CFR Part 33, t r (2) is a grant under intent of the Commission in regard to (R0057). section 208 of the clean water act. the newly adapted i 73.561 of the i FEDERAt af M5Tfs, VOt, 43. NO. 202-WIDNt50AY, OC70Mt 18,1978
40 e o 1 ' > 55346 RULES ANO REGULATIONS h ' I [3410-07-M) since they make guarantee is unci dear that thereby
>nditional, the loan (7590-01-M]
f SUSCHAPTER M -C FMER tOAM PROOAAMS benefitting the I rnding institutions Me 104nemy which participate n the FmHA guar. IPmHA lns .ruction 1980-Al anteed loan pro grarns. Therefore, CHAPTER I-NUCLEAR REGULATORY public participatfor is unnecessary. COMMISSION PART 1980-GUARANTEED LOAN Accordingly, j 1940.11 and Appendix PRO GRAMS B of Subpart A of Part 1980 of Chap- PART 35-HUMAN U5ES Of ter XVIII, Title L Code of Federal Subport A--General BYPRODUCT MATERIAL Regulations are amended as follows: AMErnutNTs 1. Section 1980. l1 is amended by Radiation Surveys of Therapy adding a sentence to the end of the p,,,,,,, AGENCY: tion, USDA.Farmr rs Home Administra- section as follows- AGENCY: U.S. Nuclear Regulatory Commission (NRC). ACTION: Etnal rule. I 1980.11 Full faith a ad credit. ' ) AC"I' ION: Final rule.
SUMMARY
- The Farmers Home Ad. * *
- As used in this paragraph and
SUMMARY
- Certain NRC licensees ministration (FmlIA) amends its regu. In any I4an Note Guarantee (includ. are authorized to treat patients with latforts credit to revise provisions of the full faith and the guarantee. Theing those now outstanding) in which temporary implants incorporating ra-effect of these :hanges is to make the phrase appears, "t:se of loan funds dioactive material. NRC wm require clear that the guarantee issued under f r unauthorized purposes" refers to such licensees to confirm the removal of the implants r,t the end of the the FmHA tional'* Thisregulations chtnge is is "uncondi-required the situation to fact agrees with in which the lender in treatment by (1) a source count and make the guarantee unconditional. the borrower that (2) a radiation survey of the patient.
loan funds are to x so used and the Failure to account fcr all implants at EFFECTIVE DATE: November 28, phrase "unauthori;ed purpose" means t onc to pt a e 1978. any purpose not !!s:ed by the lender in y, FOR FURTHE 1 INFORMATION the completed application as approved necessary radiation exposure to pa. CONTACT: by FmHA. tients and members of the general public. Darryl H. Evans Ioan Specialist, telephone 202-MT-4150. * * ' *
- EFFECTIVE DATE: The amendment becomes effective on December 28, SUPPLEMENTARY INFORMATION: 3. Paragraph It under the Parties 1978.
l 1980.11 and App?ndix U of Subpart A of Part 1980 of Chapter XVIII Title 7, Agree of Appendic B Form FmHA CO TA Code of Federal Regulations are 449-35. Lender's Arreement, is amend- ' tmended. These amendments clarify ed to add a sentence to the end of the Edward Podolak. Office of Stand. the full faith anc credit provisions of paragraph as follows: ards Development, U.S. Nuclear Reg. the Guarantee by defining the phrases ulatory Commission. Washington, p
"use of loan furnis for unauthorized purposes, and ArrcNDIX B~Fonu FuHA 449-35, D.C. 20555 (Phone: 301-443-5966).
' unauthorized pur. LENDERsAGREEMENT p P 8
The Comptroll tr of the Currency , , , , require Group VI IIcensees 8 to assure advised FmHA tMt the full faith and that patients treated with cobalt 60, credit provisions of the Loan Note Tus Psants Acum cesium 137 or iridium 192 temporary Guarantee did ni't meet the require- , implants remain hospitalized until the ments of 12 U1.C. 984 (10) which , , implants have been removed. The pri. exempts loans the t are guaranteed un.
- 11. Pull Patth and C1 edit. ' *
- mary method for confirming that all conditionally by .he Federft1 Govern- As used herein, the sources have been removed is to count ment from the lending lim't require. funds for unauthortud ptrase "use purposes" of loan refers to the sources implanted and count the ments imposed or national banks. Ac. sources removed. The source counting the situation in wht<h the lender in fact has not always been performed accu.
cording to the Ccmptroller under the agrees with the bort mer that loan funds rately, or on a timely basis. tbove cited regul,Ltions prior to these are to be so used and 1 he phrase "unauthor-Some patients have been discharged revl31ons, al. the gual It is the opinfo antee 1 of the was condition. Comptroller by the lender izedinpurpose" means the :ompleted iny purpose not listed from the hospital with radioactive application General that enactment of these revi. as approved by PmHA sources still implanted. (It is particu.
, si:ns to the full !alth and credit sec.
tions of 'the res 11ations will clearly . . . .
'The most common types of NitC specific make the new gt tarantees and previ. licenses for the medical use of byproduct ously issued guaro ntees which are sub. (7 U.S.C.1989; 5 U S <!. 30t; Sec.10. Pub. I, material are the Group medical licenses P't to Subpart A " unconditional,"'as under 13514 that apply to those radioactive 93-357. 88 Stat. 392blegation of authority matertals listed in 135.100. The radioactive that word is used n 12 U.S.C. I 84 (10). by the Sec. of Aart.,1 CFR 2 23. delegation materials listad in 1 35.100 are divided into lt is the policy of this Department of authority by the A Lst. Sec. for Itural De. six groups cach group having similar re.
thit rules relatina' to public property, ve pment, CFR 22 3 quirementa for user training and expert. loans, grants, be Tefits, or contracts Dated: October 1: , 1978. ence, f acilities and equipment, and radiation shril be publishe i for comment not. safety procedures. Groups I. !!, and !!! are cithstanding the lista of radiopharmaceuticals for diagnostic exemption in 5 GonorN CA V 4N A t'G H, procedures. Groups IV and V are lists of U.S.C. 553 with rapect to such rules. Administrator, These amendmen a. however, are not g pha,ma eude or hnajeu p published for proposed rulemaking Farmers llorr FAdministration. , medical dettres for both diagnaatte and IFil Doc. 78-33223 Ptbd 11 27-78. 8 45 aml therapeutle procedures. FEDERAL Riollitt, VOL. 43, NO. W9-fUf10AY, NovfM8th 20,1978 _ _ _ _ _ _ . _ _ _ _ N
RULES AND REGULATIONS 55347 ! L larly difficult to count tridium-192 and inexpensive and it will also detect [G750-01-M] seeds, which sometimes become dis- any sources lost in the bedclothes or lodged from their encasement in nylon room where the survey is performed. * ""* *** ribbon). Because a backup radiation Therefore, the afterinaded devices will suney of the patient could have pre- CHAPTER l-l EDERAL TRADE nt be exempted from the require-vented these incidents, on June 28 COMMIS$10N
- 1978 NRC published a proposed rule in ments f or a radiation survey.
the FEDERAL REctsTER adding a re- Final.,. regulations that define what (Docket No. 90m quirement for source counting and pa- is generally considered good practice tient radiation surveys to the existing may stem useless or may even dismay PART 13-PROHil.lTED TRADE PRAC-
$ 35.14(b s(5 xvil) which prohibits conscientious licensees. However, this TICES, AND AFFIRMATIVE CORREC.
Group VI licensees from discharging is insufficient reason to forgo these TIVE ACTIONS patients until all sources are removed. The comment period ended August 14, regulations when there is evidence Coventry Buihlers, Inc., et al. 1978. that the good practices are not univer-AGENCY: Federa: Trade Commission. Twenty-one comments were re- sal. ceived. Eleven favored the proposal Under the Atomic Energy Act of ACTION: Final or.ler. without qualification. Three com- gg$4, ,s amended the Energy Reorga-
SUMMARY
- In si ttlement of alleged rnenters suggested that bulky after- violations of federal law prohibiting nization Act of 1974, as amended and loaded devices that protrude from the unfair acts and I ractices and unfair body be exempted from the radiation sectiart. 552 and 553 of title 5 of the methods of competition, this consent survey. One commenter suggested that United States Code, notice is hereby agreement, amon : other things, re-an x ray be permitted as an alternative given that the following amendment quires a Shaker IIeights. Ohio home to the radiation survey. One com- to 10 CITI Part 35 is published as a improvements firni to cease, in connec-menter asked what was meant by "the tion with the extension of credit, fall-document subject to codification.
end of the treatment" and one com- ing to provide co Tsumers with those menter, while favoring the proposal, In 10 CFR Part 35, f 35.14(b)(5xvil) materials and dis < losures required by suggested that the radiation survey is amended to read as follows: Federal Reserve SJstem regulatiors. should be performed within one hour DATES: Complai Tt issued July 15, of source removal. Four commenters 1 35.14 Specific licen=en for certain group. 1975. Decision isued October 23. objected to the proposal because they of medical uses of byproduct material. 1978J believe that regulations that define what is already good medical practice . . . . . FOR FURTHEI INFORMATION are useless. One commenter objected CONTACT; to the proposal because he believes (b) Any licensee who is authorized to Paul R. Petersor . Regional Director, that there are some cases where it use byproduct material pursuant to 4R, Cleveland Regional Office. Fed-would be impossible to survey the pa- one or more groups in !! 35.14(a) and eral Trade Corr. mission, Suite 500, tient before discharge. Mall Bldg.,118 St. Clair Ave.. Cleve. 35.100 is subject to the following con-The wording of the final rule is the land, Ohio 44114.216-522-4207, same as the proposed and requires a ditions: radiation sursey of the patient before On Wednesday August 16,1978, there discharge. The radiation survey is the * * * *
- was published in the FEDERAL REGIS-most positive (active) method of veri- TER, 43 FR 36281, a proposed consent fying source removal. The x ray is a (5) For Group VI any licensee wh adysis In the Matter passive method. Although good prac. possesses and uses sources or devices of Coventry Builders, Inc., a corpora.
tice would suggest a radiation surve) containing byproduct material shall: tion, and Louis Callano, Sr., inidivi-soon after source removal, the regula- dually and as an cfficer of said corpo-tion has to recognize the rer.lities of . . . . . ration, for the p arpose of soliciting the clinical setting where other tasks public comment. Interested parties may have higher priority. Placing a (vil) Assure that patients treated were given sixty 0 0) days in which to tight time limit on this essentiallF submit comments, suggestions, or ob-with cobalt-60, cesium 137 or iridium-quality control function may interfere W mW fe with patient care. However, it is ex. 192 implants remain hospitalized until of order. tremely unlikely that the licensee will a source count and a radiation survey No comments hnving been received, experience difficulty performing the of the patient confirm that all im- the Commission hu ordered the issu-survey between source removal and plants have been removed. ance of the compir int in the form con-discharge of the patient, templated by the .Lgreement, made its The suggestion to exempt afterload-Jurisdictional find ngs and entered its ed devices is well made. The devices order to ceasa and desist, as set forth are bulky relative to the actual source in the proposed coasent agreement, in size and it is difficult to imagine that (sec.161. Pub.1. 83 'l03. 6a Stat. 948 (42 disposition of this )toceeding. patients would be discharged with U E n 2201t Sec 201. Pub. L 93-438. 88 The prohibited I rade practices and/ these devices in-place. Howeser NRC stat 1243 (42 UEn 5841u or corrective actions, as codified under inspectors, who are familiar with incl. Dated at Bethesda, Maryland this 16 CFR Part 13, :tre as follows: Sub-part Advertising 1 alsely or Mislead-
; dents of overexposure from implants 14th day of November 1978.
- remaining in patients, say that this is ingly: I13.73 Formal regulatory and an area where the " impossible" hap- For the huelear Regulatory Com. statutory requil ements; 13.73-92 pens in spite of great care and precau- mission. Truth in Lending Act; I13.155 Prices; tions. Also, NIIC inspectors have inves- LEE V. Oosstex, 13.155-95 Terms and conditions; tigated an incident where a patient Execulit'c Directorfor 13.155-95(a) Trut 1 in Iending Act.
was'. discharged with an af terloaded ' Operations. device in. place with the sources . copies of the De'tston and Order filed loaded. The radiation survey is simple IMt Doc 78-33229 Filed !!-27-78,8 45 aml with the original doci ment. PEDERAt SIGilitt, VOL. 43, NO. 229-TUESDAY, NOVIMtit 28,1978
( g . RULES AND RE!ULATIONS 1722 Exnta T A.-Delegation o/Purchar ag AufAontOSmall Purchases) and changes. Use Dderal and Departe mental regulation.9 for procurement In accordance with Agriculture Procureme, t Regulations 4-3.602-50, the authority to [ contracting. (Revistd) purchase with redelegation power Ls delegated ts these positions: 3, g,
- I 2024.9-202 Lil litenrved) * * " *
. I 202s.12 sales. sio.oov Deputy Aanuntstrator. rtnancial and Admwastrauve op .r anons See Exhibit C foi delegations of au-io.000 Director, summens services Dietston thority and amou:sts of sales. The Deputy otrector, aumean semces omsmn. -
to ooo General Service! Administration "'*"d5"'** ***d'" (GSA) is responsible for the disposal ^"gF,'* gDg'5' "^ to.rmo of surplus propert) . OSA regional o.- cmer. Property a Procurement usmc, sr. Property a space Memt speciant 10.000 fices can authorin agencies to sell contrutma specialat. . _ . . . _ to ovo team these items. Tlae Lignated sales will be made rwurement a smir spe taast-only by persons de C and using Fec.ecal Property Manage-in Exhibig
$Zi,737,2 "$,[ N ment Regulations < FPMR) 101-45.304, t nna.c, ome, te ooo and Agriculture Property Manage- chier. Busmess semcc. *- -
to ovo Amstant enter. numa e . . ar. ment Regulatfort ( AOPMR) 45.303. for sales to Government em-10-
"dg,;n,^g'"'M",,
M to 000 Generat supply spmanst. ... ployee3.
- 3. state O!!1ce-ruerta kcci 2.500 state otrector .. 2.500 l 202 4.13 [Ileserved) Admuustratae O!!.cer C M
$ 2021.18 f. casing, e iace acquisition, and assignment.
4-ForQ'Q Qf'}'h rw am me w e mMenmm Transportanon seruce .. _ . _ . . . . . . . ........
- 50 M
5 State Director Anceances fi r wupplies and equipment for mfor. See Exhibit D f( r delegation of au- Mpues and ,eruces not asadable :s thority and amoun a for leasing. Leas- 8. state omtor Adrnmtstrative officer, ro7e$c"treS ing authority incl.. des soliciting, and nutrwt n.re.wr. county sepervtwr. thrm 4rist touts. uasourt. rinancc orree. 2,m accepting bids, Siining reasing docu. v. ominct oir--to,. c,miy st. pen -r .. . sen we, rer mamtenance. m.n ,< ment. e, rerai, of ~reaN ' acquired" prcpert y. Mo ments and, contracting with field of- Repair and - placement of part.s and c!cs ang of flees of GSA to u ,e both leased and electrR tyt srlters and Of f.ces mxhmek Ms isn ment spermist. ror seruces wanns to the malung and senmg
'to ooo Federal space. 'l, Tis includes Post s. Prnper+,
or Emerse-ry. toestoca and Economie s:mer. Of flee facilities, alid space leased by cm,r. Pre Msmt.. Aamuustr3uve
- -ncyIdAR and Other Dr0STirn Mrstwn3 the n ortwer.
FmilA. Use FPM 't 101-18.104 101- umula w es or mm mance manage. 18.107, and AGPNR 104-18.104,104 **"t"P" ' 'nd 5'l' *' *C4 "*4 "'! D ' "* Y - 18.107 when leasin t. Acquisitions also u.se Federal Procursment Regulations. ' Yrarty $1M phs $2 50 for each f M!me co mty Of' ~ e. AGPR Subpart 4 -4.54 and FmHA w in m NA e u wam on ne d guidelines. ,q$7m wnes on me e owems awaa nt>ed procure ment contru tmg course ud prece-
'Only f ar emplo> ees s ha hase comr!eted the pre' d ares.
j 202 t.l*>-2021.20 [lL servedl k TMs de! Nation replaces all others and is tall .1 until changed or canceled. j j 202 8.21 Authority 4,f acting and supervi- Pm pba m the.w positions. or those acting for them. can use thts authority. sary officials. . t%e Fnteral Pmeure" lent Regulatnans. Suby :rt 13 6; .4;rsctature Proctarente*nt Rev.la-trou. separt J.3 a: and Agency regulations tha apply to uand this authority. Employees who are designated to act Authartty to purchase ull not be used for ( tntracting at construction except for Items In place of a persJn with a position 7 and a abose. having delegated ;,uthority, can also use the authortt) Exceptional Con- (5 UE C. 30D ! tracting aut horit: The Employee Dated: December 28,1978. must be qualified. see in FmifA regu. Jwrs E. TitoRNToM, lations. Exercise of delegated authort- ,tssociate AdminiJtrator ty by officials is c ot to be based on Farmers Home Administration. l their supersisory c: pacity on)y. t1Tt 79-574 Ft!ce 1-5-79. 8.43 aml J Attachments Exh: alts A. D, C, and D. 9 regulations to require medical licens-(7590-01-M] ers to (1) calibrate each teletherapy Title 10- Energy unit annually and (2) perform month. ly sp t checks on those cahbrations. CHAPTER l-NUCLEAR REGULATORY The annual full calibrations must be. COMMI55lON performed by a quallfled expert. The PART 35-HUMAN U$ES Op monthly spot checks need not be per. f rmed by a quallfled expert but the 8YPRODUCT MATERIAL results of the spot checks must be re-Calibration of Teletherapy Units Stewed by a qualified ex;'ert on a timely ba. sis. AGENCY: U.S. Nuclear Regulatory The amendments will help ensure Commission. that a patient retelves the prescribed ACTION: Final rule, radiation dose t - requiring that te-
SUMMARY
- The Nuclear Regulatory letherapy units are properly calibrat-Commission (NRC) is amending its ed.
f tDER AL AEGilitt, VOL. 44, NO. S-Mot 40AY, JANU ARY 0, H19
- g. RULES AND RE2ULATIONS 1723 EFFECTIVE DATE: The amendments whether NRC was the appropriate fed- in the proposed teletherapy calibra-become effecthe on July 9,1979. Any eral agency to rec,uire calibrations of tion rule has been deleted from the full calibrations performed in accord- teletherapy units. final rule. All comments received on ance with the pr >cedures in t his The Commission agrees with those this subject will be considered as com-amendment during the 365 days prior commenters who pointed out that the ments on the more comprehemne pro to the effecthe date of this amend- Itiverside Hospital incident in ohing posed misadmmistration reporting re -
rnent will count as the first full cah- 400 patients was an isolated case and quirement that was published in the bration. that NRC's efforts to alert other li. FmnAr. HrcisTEE on July 7, 1978 (43 cemet s and check on their calibra. FR 29297) for public comment. Non-The Nuclear Regulatory Commis-sion Lu submitted this rule to the Comp. tions were successful. However, the troller Gent ral for reuem under the Federal Commission belleses that the Rh er- ID AL NN Hrports Act. as amended. 44 U S C 3512. side incident esidences the magnitude The date en which the rule becomes effee- of the harm which could be caused by NRC has decided to issue the fmal the. unier.s adused to the contrary, accord a single uncalibrated teletherapy unit. rule by addmg (( 3521-35 25, inclustvt. tr.gl> re flects inclumn of the 45-day period The purpose of this rule is to ensure to 10 CFR Part 35 rather than bv U ' " ' * " ' that teletherapy units re main proper- amendmg ( 35.13 as proposed. This '
~ '[5 2 '
ly calibrated throughout their useful change will make the final rule easier FOR FURTHER INFORMATION lives. to read and understani It will also be CONTACP Those commenters who questioned clear that the rule pertains only to te-Mrs. Patricia C. Vacca. Division of whether NRC w as the appropriate letherapy units and not to other Fuel Cycle and Material Sa fet y, agency to requ!re calibration of teleth- sealed sources. Ofhce of Nuclear Material Safety erapy units, pointed to potential con- As discussed in Section I abos e, t he flicts with the Food and Drug Admin- misadministration reporting require-and Safeguards. U.S. Nuclear Regu. , latory Commission. Washingt on, istration's (FDA) new authority under ment of the proposed rule has been D.C. 20555 (301-427-4232). the Medical Device Amendments of deleted. 197ti Through the Atomic Energy Act Section 3511 on full calibration hv SUPPLEMENTARY INFORM ATION. of 1954, as amended, and the Energy been expanded to require full cahbra-On May 19,1977, the NRC pubh3hed Reorganization Act of 1974, as amend- tion following any repair of the teleth-in the FEDERAL RictsTrn (42 FR 25743) ed. NItC has direct regulatory control etapy unit that includes remosal of pro;>osed amendments to its regule our the human use of byproduct ma- the source or major repair of the com-tions prrtaining to the human ust s of terial in teletherapy units. NRC is the ponents associated with the source ex-byproduct materials including teleth- c,nly Fede ral Agency with direct regu- posure assembly and prior to treating crapy units. The proposed ame nd- latory control oser the tae of byprod- humans In f 35.21 the term "signif t-ments to { 35.13 would hase required uct material and, as such, is certamly cant change." w hich related to the teletherapy licensees to: an appropriate agency to require cali- spot-check measurement and will trig-
- 1. llave a qualified expert perform bration of NRC regulated teletherapy ger a recalibration, now reads " output full cslibration measurements at least units. NRC is aware that its responsi- differs by more than 5 percent." Sec-once each year; bilities and those of FDA do eserlap in tion 3531 now includes a performance
- 2. Perform spot-check measurement 3 the area of medical destces. NHC and standard of "to an accuracy within 1 on their telethe rapy units at least FDA staff members hase met on sever- 3 percent" for the calibration of te-monthly; and al occasions to coordinate the respon- letherapy output. Fmally, ( 35.21 now
- 3. Re port to NRC if these measure. sibilities of the two agcncies. It ap- includes a requirement to correct the monts indicate that patients treated pears that it will be some time before calibration of teletherapy output for by teletherapy units receised a radi- the FDA has standards or guidelines physical decay at int ers als not to ation dose differing from the p re- in place for teletherapy calibration. As exceed one month.
.=cribed dose by more than 10 percent. they are deuloped. NRC will work Und( r the eff ecthe rule, the licensee The public was invited to submit closely with FDA to minimize overlap- generally will not have to submit the written comments and suggestions on ping regulation by the tso ngencies- training and experience of the quall-the proposed amendments. The com- One commenter suggested that li" fied expert to NRC for evaluation.
ment period'. originally set to close on constes be required to participate in Rather { 35.24 requires the licensee to July 5,1977, was extended to July 29 calibration check programs such as determine, pursuant to the provistoru 1977. those sponsored by FDA or the Na- of that section. if a person is an expert I" COMMENTS ON PRoPost:D RtJLE mission encourages teletherapy licens- calibrate teletherapy units. The licens-Fifty nine comments were received. ecs to participate in voluntary calibra- ee will then keep records of that esalu-Copies of the comments and a detailed tion check programs but will not re- ation of the expert's training and ex-anal 3 sis of the comments may be ex- quire it. perience for inepection by NRC. amined in the NRC Public Document Several commenters did not under- A new requirement h.v been added Room at 1717 11 Street. NW., Wash- stand that a qualified expert need not to ensure that dosimetry mtems used ington D.C. Approximately one half actually perform the spot-che(k mea- to calibrate the teletherapy umts are of the commenters supported the pro- surements. The final rule states clear- also properly calibrated Section 35.23 posed rule. Of the remainder, approxi- ly that the qualified expert need not requires that the dosimetry system mately one half disapprosed of the actually perform the spot check, but used for full calibrations has itself proposed rule and the other half were the results of the measurements must been calibrated by the National non committal. Virtually all of the be res iew ed by a qualified ex pe rt Bureau of Standards (NES) or by one comm(nters offered helpful sugges- within 15 days. of three Regional Calibration labora-tions, most of which were accommo- There were numerous comments on tortes (RCla. who in their turn are di-dated as detailed in Section 11 below, the section of the proposed rule that rectiy " traceable" to Nils. Alternative-t " Summary of Major Changes in ihr w ould has e required reporting to ly, a dostmetry system used solely for final Ride". NRC, and to the patient's referring spot-check measurements may be cali-Most of the commenters who disap- physician, certain misadministrations brated by direct intercomparison with proted of the proposed rule ques- insching teletherapy units. The mis- a system calibrated by Nils or one of tioned either the need for a rule or administration reporting requirement the RCLs. Pf0ER AL REG 45ftR, VOL. 44. NO. $-MONDAY, JANUARY 8,1979 C_
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, , , . 1724 autel AND REOutAMONS III. Pts:L Ruts (d) The exposure r:te or dose rate in Medicine. The dosimetry system Pursuant to the Atomic Energy Act values determined in paragraph (bx1) shall have been calibrated within the of 1954, as amended, the Energy Reor. of this section shall be corrected previous two years and after any serv.
ganization Act of 1974. as amended mathematically for physical decay for icing that may have affected system and Sections $52 and 553 of Title 5 of in enals n t exceedng one m nth. cahbradon. the United States Code the following (e) Full calibration measurements (b) Spot-check measurements re-tmendments to Title 50. Chapter I* required by paragraph (a) of this sec. quired by I35.22 shall be performed Code of Federal Regulations, Part 35 ti n and physical decay corrections re. using a dosimetry system that has are published as a document subject to quired by paragraph (d) of this sectica been calibrated in accordance with codification. shall be performed by an expert quali. paragraph (a) of this section. Alterna. 10 CFR Part 35 is amended by fled by training and experience in ac- tively, a dosimetry system used solely cdding a new center heading and new c rdance with { 35.24. for spot-check measurements may be lj 35.21-35.25, as follows: g 3 >.22 calibrated by direct intercomparison Requirement to perform periodic with a system that has been calibrated SrECIAL REQUIREMENTS rOR spot-check measurements of telether- in accordance with paragraph (a) of TE!ErHERArY IJCENSEES apy umts, this section. This alternative calibra-(a) Any licensee authorized under tion method shall have been per-f 35.21 Requirement to perform full call- $ 35.13 to use teletherapy units for formed within the previous one year brution measurements of teletherapy treating humans shall cause spot- and after each servicing that may}}