ML20137H147
| ML20137H147 | |
| Person / Time | |
|---|---|
| Issue date: | 03/20/1997 |
| From: | Lohaus P NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | Fletcher R MARYLAND, STATE OF |
| References | |
| NUDOCS 9704020071 | |
| Download: ML20137H147 (79) | |
Text
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Mr. Roland G. Fletcher, Manager Radiological Health Program Air and Radiation Management Administration ')
Maryland Department of the Environment i 2500 Broening Highway ,
Baltimore, MD 21224 !
Dear Mr. Fletcher:
We have completed a review and evaluation of the Final Maryland Rules, COMAR 26.12.01.01, Part X "Use of Radioactive Materials in Irradiators" for compatibility with I equivalent NRC regulations contained in the Title 10, Code of Federal Reaulations, Part 36.
The final rule was received by express mail on March 3,1997. Based on our review, we ,
find Part X to be compatible with Part 36. We note that in response to a sole remaining !
comment identified in my August 21,1997 letter to you, that Maryland has added a sentence at the end of Section X.39 to read: " Construction shall not begin until the agency has reviewed and approved plans submitted by the Applicant." The addition of this sentence resolves this comment.
If you have any questions regarding this letter, please contact me at (301) 415-2326 or Patricia Larkins at (301) 415-2309.
Sincerely, 1 OriginalSigned By:
PAUL H. LOHAUS Paul H. Lohaus, Deputy Director Office of State Programs
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Distribution. i DlR RF ' DCD (SP05) j SDroggitis PDR (YES v' NO ) j FCameron CGordon, RSAO, RI Maryland File 020011 l DOCUMENT NAME: G:\PML\MDPARTX.LTR *See previous concurrence.
To receive a copy of this document, indicate in the boa: "C" = Copy without attachment / enclosure *E* = Copy with attachmerit/ enclosure 'N" = No copy OFFICE OSP l OSP:DD l OGC l OSP:g </ , l l NAME PMLarkins:nb PHLohaus FCameron RLBangart 'Ti>
DATE 03/17/97* 03/17/97* 03/20/97* O'$fff970 OS
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. s Mr. Roland G. Fletcher, Administ ator :
Radiological Health Program Maryland Department of the Envir ment ;
j 2500 Broening Highway Baltimore, MD 21224 j
l Dear Mr. Fletcher- !
We have completed a review and evaluation of the Final Maryland Rules, COMAR 26.12.01.01, Part X "Use of Radioactive Materials in irradiators" for compatibility with equivalent NRC regulations contained in t e Title 10, Code of Federal Reoulations, Part 36. t The final rule was received by express mai on March 3,1997. Eased on our review, we find Part X to be compatible with Part 36. e note that in response to a sole remaining comment identified in my August 21,1997 tter to you, that Maryland has added a
- sentence at the end of Section X.39 to read: " Construction shall not begin until the agency '
has reviewed and approved plans submitted the Applicant." The addition of this sentence resolves this comment.
If you have any questions regarding this letter, ease contact me at (301) 415-2326 or Patricia Larkins at (301) 415-2309.
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S'ncerely,
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- Pau H. Lohaus, Deputy Director Offi(ce of State Programs 4
Distribution:
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- No copy OFFICE @Q Lj OSg@ Q l '\AGC l OSP:D l l NAME PMLarkins I.nfr 1 ' ' PHLohaut ' ' ' FCarneron 8LBangart DATE 03/17/97 03/17/97 \ 03/ /970 03 9 /97 OS ' FILE CODE:
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ROUTING AND TRANSMITTAL SLIP l
DATE: March 17,1997 CONCURRENCE / SIGNATURE :
- 1. 'CJCAMERON, OGC - CONCURRENCE 1
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LETTER TO: ROLAND G. FLETCHER, ADMINISTRATOR l RADIOLOGICAL HEALTH PROGRAM MARYLAND DEPARTMENT OF THE ENVIRONMENT ,
FROM: PAUL H. LOHAUS, DEPUTY DIRECTOR I OFFICE OF STATE PROGRAMS
SUBJECT:
REVIEW OF FINAL MARYLAND RULES, COMAR 26.12.01.01, PART X YOUR CONCURRENCE IS REOUESTED BY WEDNESDAY. MARCH 19.1997/
I OSP CONTACT: PATRICIA M. LARKINS 415-2309 1
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PLEASE CALL NANCY BELMORE. OSP. 415-2326. FOR PICK-UP2 l t
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Mr. Roland G. Fletcher, Administrator Radiological Health Program Maryland Department of the Environment 2500 Broe6g Highway Baltimore, MD 21224
Dear Mr. Fletcher:
We have completed a review and evaluation o ,the Final Maryland Rules, COMAR-26.12.01.01, Part X "Use of Radioactive Matefials in irradiators" for compatibility with equivalent NRC regulations contained in the Titl'e 10, Code of Federal Reaulations, Part 36.
The final rule was received by express mail on fdarch 3,1997. Based on our review, we
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find Part X to be compatible with Part 36. We note that in response to a sole remaining comment identified in my August 21,1997 letter'jo you, that Maryland has added a sentence at the end of Section X.39 to read: " Construction shall not begin until the agency -
has reviewed and approved plans submitted by the\ Applicant." The addition of this sentence resolves this comment.
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If you have any questions regarding this letter, please contact me at (301) 415-2326 or ;
Patricia Larkins at (301) 415-2309. \
Since\ rely,
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Paul H. Lohaus, Deputy Director Office of' State Programs j
\ 1 Distribution: 1 DIR RF DCD,(SPOS)
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DOCUMENT NAME: G:\PML\MDPARTX.LTR TD receive a copy of this do<
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- E" = Copy 'with attachment / enclosure Mind 6cete in the bos: *C" Spyhithout attachment / enclosure *N" = No copy OFFICE
@QQ OS(DpM l OGC l ' OSP:D l l NAME PMLarki?ls'I.nY) PHLohaui I ' ' FCameron RLBangart DATE 03/17/97 03/17/97 03/ /97 03/ /970 OS ' FILE CODE: i l
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NUCLEAR REGULATORY COMMISSION WASHINGTON. D.C. 20066 4 001 March 20, 1997 Mr. Roland G. Fletcher, Manager !
I Radiological Health Program Air and Radiation Management Administration i
Dear Mr. Fletcher:
I We have completed a review and evaluation of the Final Maryland Rules, COMAR I 26.12.01.01, Part X "Use of Radioactive Materials in irradiators" for compatibility with equivalent NRC regulations contained in the Title 10, Code of Federal Reaulations, Part 36. i The final rule was received by express mail on March 3,1997. Based on our review, we '
find Part X to be compatible with Part 36. We note that in response to a sole remaining
, comment identified in my August 21,1997 letter to you, that Maryland has added a sentence at the end of Section X.39 to read: " Construction shall not begin until the agency !
has reviewed and approved plans submitted by the Applicant." The addition of this l sentence resolves this comment. I If you have any questions regarding this letter, please contact me at (301) 415-2326 or 1 Patricia Larkins at (301) 415-2309.
l S' cerely, ,
- ') / l
, (W, . \(<(;l L-' Paul H. Lohaus, Deputy Director Office of State Programs l
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l March 3,1997 i i I i ! f NOTE TO FILE: ! ,i
SUBJECT:
STATE OF MARYLAND FINAL COMAR REGULATION--PART 36 :. EQUIVALENT REGUI.ATION, COMAR 26.12.01.01, SECTION X, "USE OF
- RADIOACTIVE MATERIALS IN IRRADIATORS" l i
1 I As requested by telephone in a 2/28/97 discussion with Roland Fletcher, a courier hand delivered the Final Irradiator Rule, that became effective December 16,1997, for NRC review ! i - and a compatibility determination. Regulation received in OSP on 3/3/97, at 3:00 pm. ! t i
- l l 1 '
Patricia Larkins 1 i i i i i , s j i ,' I i ! i i i J 1, l 1 -i t i
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INSTRUC110N SHEET - COMAR 26.12.01.01
Title:
Reeulations for the Control of
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lonizine Radiation (1994) OSP > r ADOITED SUPPLEMENT No.1 M 3* 03 I l TO: HOLDERS OF COMAR 26.12.01.91 " MARYLAND STATE REGULATIONS FOR CONTROL OF IONIZING ! RADIATION (1994)." j l Supplement I to the document COMAR 26.12.01.01 " Regulations for the Control of lonir.ing Radiation (1994)" has been adopted and is effective as of December 16, 1996. He pages that are necessary to update your copy of the regulations are , enclosed and ready for insertion in your permanent regulations binder. Please follow these instructions carefully. ! Instnietions: A. locate the permanent regulations binder in your possession. ! B. Change the permanent binder now as follows: l i Carefully follow the " remove / insert" instructions appearing below. Remove the obsolete pages listed under .l the column " Remove Pages" from the permanent binder. From the package of pages enclosed, insen the new l or replacement pages listed under the column " Insert Pages" in the permanent binder. Each of these pages < has at least one of the two faces of the page printed with the words "Supp.1" in a lower corner. He obsolete pages removed from the permanent binder may be retained in a separate place for legal research. ) i ALL PAGES ARE INCLUSIVE i Remove Paees From Binder Insert Pares From Enclosure i xiii xiii i A1/A2 Al/A2 A7 through A16 A7 through A16 C11/C12 Cll/Cl2 C25/C26 C25/C26, C26-1/C26-2 C37/C38 C37/C38 D29 through D32 D29 through D32 D41/D42 D41/D42 E1/E2 El/E2 E9 through E12 E9 through E12 F17/F18 F17/F18 Gl/G2 GI/GI-1, G2 G27/G28 G27/G28 G35 through G37 G35 through G37 (no corresponding pages) XI through X16 C. File this instruction sheet in the permanent binder behind a tab labeled " Instruction Sheet." D. You will be sent further instructions sout upcoming supplements when later action affects these regulations. INQUIRIES TO: Radiological Health Program Maryland Department of The Environment ) 2500 Broening Highway Baltimore, MD 21224 < (410) 631-3300 l
.. . . - . .. - -- - - . - . _ ~ - - . - . - ... _.-. ~. .
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s ! INSTRUCTION SHEET COMAR 26.12.01.01 i l Title Reruhtions for the Control of Ionizing i
- Radiation (1994) i i PROPOSED SUPPLEMENT No.1 l TO: STATE DEPOSITORIES 1 i 8
Instructions: Supplement I to the document " Regulations for the Control of Ionizing Radiation i L (1994)" is being proposed for adoption. Supplement 1 includes the following pages (all pages ; are inclusive): ; i Cover Sheet { l Page xiii, , i
- Pages Al and A2, A7 and A8, A9 and A10, All and A12, A13 and A14, A15 and A16, l l Pages C11 an._ C12, C25 and C26, C26-1 and C26-2, C37 and C38,
- Pages D29 and D30, D31 and D32, D41 and D42, !
Pages El and E2, E9 and E10, E11 and E12, ! l Pages F17 andF18,
- f. Pages G1 and G1-1, G2, G27 and G28, G35 and G36, and G37, Pages X1 through X16 '
Check to make certain that you have all the pages listed above. l i There is no page removal or insertion to do in the permanent document binder at this time. You ! I will be sent further instructions when later action affects this proposed supplement. l INQUIRIES TO: William K. Bonta 4 Radiological Health Program i Maryland Department of The Environment '
- 2500 Broening Highway l l Baltimore, MD 21224
i (410) 631-3300 t i
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COMAR 26.12.01.01 REGULATIONS FOR THE CONTROL OF IONIZING RADIATION (1994) . SUPPLEMENT 1 (Proposed) COVER SHEET ! The document refemnced above is proposed for incorporation by reference. The proposal l to incorporate the document will appear in [ enter Vol. No., issue No., and Pg. No.] Md.R l l [ enter date of proposal). A notice of final action will appear in a subsequent issue of the , Maryland Register, and will give the date on which the revisions in the document aferenced I above will become effective. . i This document contains substantive and non-substantive changes as shown.in the l following' table of page numbers: ! 4 . Suoolement 1 Pare Numbers l i j Substantive Non-Substantive i
- A8 through A10, A14 xiii i C2.6, C26-1 A2, A9, All, A15 ;
} G1-1 C12, C26-2, C37 , 3 XI thmugh X15 D30, D31, D41
- E2, E10, E11 I i
F17 [ G1, G2, G27, G28, G35 thmugh G37 l 4 i I i l t [end of table] l t i !
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_ __ __ . _ _ -_ _ _ _ _. ~ _ - _ _ _ _ _ _ . ._ . . _ _ i i l I USE OF RADIOACTIVE MATERIALS IN IRRADIATORS i l ! i Genatal Provisions ! Section X.1 Purpose and Scope . . . . . . . . . . . . ............................. X1 Section X.2 Def i nitio n s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . X 1 } Design and Performance Requirements for Irradiators Section X.21 Performance Criteria for Sealed Sources . . . . . . . . . . . . . . . . . . . . . . . . . . . . X.2 Section X.23 Access Control . . . . . . . . . . . . . . ............................... X.3 Section X.2 5 Shielding . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . X.4 ' Section X.2 7 Fire Protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . X.4 j i , Section X.29 Radiation Monitors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . X.4 l Section X.31 Control of Source Movement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . X.5 l t Section X.33 Irradiator Pools . . . . . . . . .. . .. .... ............................ X.5 Section X.3 5 Source Rack Protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . X.6 , Section X.37 Power Failures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . X.6 . Section X.39 Design Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . X.6 i Section X.41 Construction Monitoring and Acceptance Testing . . . . . . . . . . . . . . . . . . . . . . X.7 i Operation of irradiators : Section X.51 Training . . . . . . . . . . . . . . . .. .. ............................... X.8 l Section X.53 Operating and Emergency Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . X.10 l Section X.55 Personnel Monitoring . . . . . . . . . . ..............................X.11 1 Section X.57 Radiation Surveys . . . . . . .. . .. .. .............................X.11 Section X.59 Detection of Leaking Sources . . . ... ............................X.12 i Section X.61 Inspection and Maintenance ., . . . ..............................X.12 i Section X.63 Pool Water Purity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . X.13 i Section X.65 Attendance During Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . X.13 i Section X.67 Entering and Leaving the Radiation Room ..........................X.14 Section X.69 Irradiation of Explosive or Flammable Materials . . . . . . . . . . . . . . . . . . . . . . X.14 , i Records l Section X.81 Records and Retention Periods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . X.14 Section X.83 R eports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . X.15 i i o l . l I ! p e i 4 xiii Supp.1 i a t e 1 I i t f !
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, PART A 4
MEERAL PROVISICES Sec. A.1 Econe. Except as otherwise specifically provided, these regulations apply to all persons who receive, possess, use, transfer, oidh, or acquire any source of radiation; provided, however, that nothing in these regulations shall apply to any person to the extent such person is subject to regulation by the U.S. Nuclear Regulatory Commission.1 Sec. A.2 Def i ni tie == . As used in these regulations, these terms have the definitions set forth below. Additional definitions used only in a certain l part will be found in that part. ' i "At " means the =mv4== activity of special form radioactive material permitted l in a Type A package. "A2 " means the mari== activity of radioactive material, ; other than special form radioactive material, permitted in a Type A package. ; These values are either listed in Appendix A of Part T of these regulations, Table I, or may be derived in accordance with the p;ocedure prescribed in l j Appendix A of Part T of these regulations.
" Absorbed dose" (See " Dose"] i
" Accelerator-produced material" means any material made radioactive by a particle accelerator.
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"Act" means the Annotated Co'de of Maryland, Envirnnment Article, Title 8
" Radiation".
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" Activity" means the rate of disintegration or (transformation) or decay of !
radioactive material. The units of activity are the becquerel (Bq) and the { curie (Ci). j "Adulta means an individual 18 or more years of age. l'
" Agency" means the Maryland Department of Environment, Radiological Health f Program.
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" Agreement State" means any State with which the U.S. Nuclear Regulatory Ceaunission or the U.S. Atcaic Energy Comunission has entered into an effective agreement under subsection 274b. of the Atomic Energy Act of 1954, as amended ;
(73 Stat. 689). !
" Airborne radioactive material" means any radioactive material dispersed in the air in the form of dusts, fumes, particulates, mists, vapors, or gases.
1 Attention is directed to the fact that regulation by the State of source f material, byproduct material, and special nuclear material in quantities not [ sufficient to form a critical mass is subject to the provisions of the j agreement between the State and the U.S. Nuclear Regulatory Commission and to 10 CFR Part 150 of the Commission's regulations. A1 !
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" Airborne radioactivity area" means a room, enclosure, or area in which airborne .
l radioactive material exists in concentrations: i (1) In excess of the derived air concentrations (DACs) specified in Appendix B, Table I of Part D of these i regulations, or { (2) To such a degree that ' an ' individual . present in the ' area without # respirator protective equipment could exceed, during the hours an individual is present in a week , an intake of 0.6 percent of the ; annual limit on intake (ALI) or 12 DAC hours. 4
" Annually" means either (1) at intervals not to exceed 1 year oz. (2) once per i year, at about the same time per year (plus or minus 1 month) . l t
"As low as reasonably achievable (ALARA)
- means making every reasonable effort to maintain exposures to radiation as far . below the dose limits in these- ;
regulations as is practical, consistent with the purpose for which the licensed; or registered activity is undertaken, taking 'into account the state of l technology, the economics of improvements in relation to state of technology, the ! economics of improvements in relation to benefits to the i safety,1 and other societal and socioeconcaic considerations,and public health and in relation to i utilization of nuclear energy and licensed or registered sources of radiation in the public interest. i
- Background radiation" means radiation from cosmic sources; naturally occurring !
radioactive materials, including radon, except as a decay product of source or special nuclear material, and including global fallout as it exists in the .l environment from the testing of nuclear explosive devices. " Background ! i radiation" does not include sources of radiation frcsi radioactive materials or radiation producing machines regulated by the Agency. i i,
" Becquerel" (Bq) 'means the SI unit of activity disintegration or transformation per second (S-1) . One becquerel is equal to 1 l l
" Bioassay" in some cases, means the determination of kinds, quantities or concentrations and,. !
by direct measurement, the locations of radioactive material in the human body,whether { in vivo counting, or by analysis and evaluation ' of materials excreted or removed from the human body. For purposes of these regulations, "radiobioassay"~is an equivalent term. i I
" Byproduct material" means:
(1) Any radioactive material,- except special nuclear material, ! yielded in or- made radioactive by axposure to the radiation ! incident to the process of producing or utilizing special nuclear material; and ! (2) The tailings or wastes produced by the extraction or i concentration of uranium or thorium frem ore processed primarily ! for its source material content, including discrete surface wastes -! resulting from uranium or thorium solution extraction processes. Underground ore bodies depleted by these solution extraction i operations do not constitute " byproduct material" within this definition. J i i i 1 Supp.1 A2 l
" Interlock" means a device arranged or connected such that the occurrence of an event or condition is required before a second event or condition can occur or continue to occur. " Internal dose" means that portion of the dose equivalent received from radioactive material taken into'the body. " License" means all or any part of permission that:
(1) is required by law to be obtained from an agency; (2) is not required only for revenue purposes; and (3) is in any form, including: (i) an approval; (ii) a certificate; (iii) a charter; (iv) a permit; or tv) a rejistration.
" Licensed material" means radioactive material received, possessed, used, transferred or disposed of under a general or specific license issued by the Agency.
" Licensee" means any person who is licensed by the Agency in accordance with these regulations. i
" Licensing State" means any State with regulations equivalent to the Suggested State Regulations for Control of Radiation relating to, and an effective program for, the regulatory control of NARM and which has been granted final j designation by the Conference of Radiation Control Program Directors, Inc. l
" Limits" [See " Dose Limits")
" Lost or missing licensed material" means licensed material whose location is unknown. This definition includes licensed material that has been shipped but has not reached its planned destination and whose location cannot be readily traced in the transportation system.
" Major processor" means a user processing, handling, or manuf'acturing radioactive material exceeding Type A quantities as unsealed sources or j
material, or exceeding 4 times Type B quantities as sealed sources, but does l not include nuclear medicine programs, universities, industrial radiographers, or small industrial programs. Type A and B quantities are defined in Section 71.4 of 10 CFR Part 71.
" Member of the public" means an individual in an unrestricted area. An i individual is not a member of the public during any period in which the individual receives an occupational dose.
" Minor" means an individual less that 18 years of age.
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'M:nitoring* means the measurement of radizion, radioactive material cone.nerations, surface area . activities or quantities of radioactive material and the use of the results of thee measurements to evaluate i potential exposures and doses. For purposes of these regulations, " radiation monitoring" and " radiation protection i monitoring" are equivalent terms. t
*N ARM" means any naturally occurring or accelerator-produced radioactive material. It does not include byproduct, source, or special nuclear material. l I " Natural radioactivity" means radioactivity of naturally occurring nuclides. " Nuclear Regulatory Commission" (NRC) means the U.S. Nuclear Regulatory Commission or its dij authorized representatives. ,
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" Occupational dose" mcara the dose received by an individual in the course of employment in which the!
individual's assigned duties involved expose a to sources of radiation, whether in the possession of the licensee, registrant, or other person. Ompational dose does not include dose received: from l background radiation, as a patient from medical practices, from voluntary participation in medical research programs, or as a member of the public. ' t
" Package" means the packaging together with its radioactive contents as presented for transport. ! " Particle accelerator" means any machine capable of accelerating electrons, protons, deuterons, or other charged particles in a vacuum and of discharging the resultant particulate or other radizion into a medium !
at energies usually in excess of 1 MeV. ; t
" Person" means an individual, receiver, trustee, guardian, p. mnal representative, fiduciary, or i representative of any kind and any partnership, firm, association, corporation, or other entity. " Person" !
includes any public or municipal corporation and any agency, bureau, department, or instrumenta state or local government and, to the extent authorized by federal law, federal government. {
" Personnel monitoring equipment" ISee " Individual mcnitoring devices")
Pharmacist" means an individuallicensed by this State to compound and dispense drugs, prescriptio and poisocs. i
" Physician" means an individual who is authorized under the Maryland Medical. Practice Act to practic; medicine in this State. '
" Prescribed dose" means:
(1) For gamma stereotactic radiosurgery, the total dose as documented in the written directive; ! (2) For teletherapy, the total dose and dose per fraction as documented in the written directive; or (3) For brachytherapy, either the total source strength and exposure time or the total dose. as documented in tne written directive. ' I Supp.1 A8 . i
"Public dose" means the dose received by a member of the public from exposure to radiation and to radioactive material released by the licensee or registrant, or exposure to sources of radiation either within a licensee's or registrant's unrestricted areas. It does not include occupational dose, dose received from background radiation, dose received as a patient from medical practices, or dose from voluntary participation in medical research programs.
"Pyrophoric liquid" means any liquid that ignites spontaneously in dry or moist air at or below 130 'F (54.4 "C). A pyrophoric solid is any solid material, other than one classed as an explosive, which under normal conditions is liable to cause fires through friction, retained heat from manufacturing or processing or which can be ignited readily and, when ignited, burns so vigorously and persistently as to create a serious transponation, handlir.g, or disposal hazard. Included are spontaneously combustible and water-reactive materials.
" Quality factor" (Q) means the modifying factor, listed in Tables 1 and 2 of A.13, that is used to derive dose equivalent from absorbed dose.
" Rad" means the special unit of absorbed dose. One rad is equal to an absorbed dose of 100 erg / gram or 0.01 joule / kilogram (0.01 gray).
" Radiation" means alpha particles, beta particles, gan1ma rays, x rays, neutrons, high-speed electrons, high-speed protons, and other particles capable of producing ions. For purposes of these regulations, l ionizing radiation is an equivalent term. Radiation, as used in these regulations, does not include non-ionizing radiation, such as radiowaves or microwaves, visible, infrared, or ultraviolet light.
" Radiation area" means any area, acces.sible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 0.05 mSv (0.005 rem) in I hour at 30 centimeters from the source of radiation or from any surface that the radiation penetrates.
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" Radiation machine" means any assemblage of components capable of producing radiation except those I
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devices with radioactive material as the only source of radiation. This assemblage may include, as determined by the Agency: (1) Not more that one control panel; (2) The necessary supporting structures; and (3) Any additional components or auxiliary equipment that function with the assemblage to produce the result desired by using the machine.
" Radiation safety officer" means an individual, authorized by the agency under a specific license or a registration. who has the knowledge and responsibility to apply appropriate radiation protection '
regulations. Radioactive material" means any solid, liquid, or gas which emits radiation spontaneously. l
" Radioactivity" means the transformation of unstable atomic nuclei by the emission of radiation.
" Registrant" means any person who is registered with the Agency and is legally obligated to register with the Agency pursuant to these regulations and Act.
A9 S"PP1
"Regictration* means registration with the Agency in accordance.with the
- regulations adopted by the Agency.
" Regulations of the U.S. Department of Transportation" means the regulations in 49 CFR Parts 100-109. "Rena means equivalent. the special unit of any of the quantities expressed as dose The dose equivalent in rom is equal to the absorbed dose in rad multiplied by the quality factor- (1 rea = 0.01 sievert) . "Research and development" means (1) theoretical analysis, emploration, or experimentation; or' (2) the extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials, and processes. Research and development does not include the internal or external administration of radiation or radioactive material to human beings. " Restricted area" asans an area, access to which is limited by the licensee or registrant for the purpose of protecting individuals against undue risks from exposure to sources of radiation. A restricted area does not include areas used be setasapart residential quarters,area.
as a restricted but separate rooms in a residential building may
" Roentgen" means the special unit of emnosure.
10-4 coulombs / kilogram of air (see "Exnosure") . Ono roentgen (R) equals 2.58 x
" Sealed source" means radioactive material that is permanently bonded or fixed in a capsule or matrix designed to prevent release and dispersal of the radioactive material under the most severe conditions which are likely to be encountered in normal use and bandling.
- Shallow dose equivalent" (See " Dose"]
"SI" means the abbreviation the International System of Units.
"Sieverta equivalent. means the SI unit of any of the' quantities expressed as dose The dose equivalent in sievert is equal to the absorbed dose in gray multiplied by the quality factor (1 av = 100 rem) .
' Site Boundary" owned, means that line beyond which the land or property is not leased, or otherwise controlled by the licensee or registrant.
" Source material" means:
(1) Uranium or thorium, or any combination thereof, in any physical or chemical form; or (2) Ores that contain by weight one twentieth of 1 percent (0.05 percent) or more of uranium, thorium, or any combination of uranium and thorium. Source material does not include special nuclear material. A10
l
~ " Source material milling" means any activity that results in the produr: tion of byproduct
, material as defined by definition (2) of byproduct material. :
" Source of radiation" means any radioactive material or any device or equipment emitting, or ;
capable of producing radiation. 1 "Special form radioactive material" means radioactive material which satisfies the following ! cenditions: ' (1) It is either a single solid piece or is contained in a sealed capsule that can be opened only by destroying the capsule: (2) The piece or capsule has at least one dimension not less than 5 millimeters (0.197 inch); and (3) It satisfies the test requirements specified by the U.S. Nuclear Regulatory ! Commission. A special form encapsulation designed in accordance with the U.S. Nuclear Regulatory Commission requirements in effect on June 30,1983, and constructed prior to July 1,1985, may continue to be used. A special form encapsulation either designed or constructed after June 30, 1985, must meet requirements of this definition applicable at the time of its design or construction.
"Special nuclear material" means:
(1) plutonium, uranium-233, uranium enriched in the isotope 233 or in the isctope 235, and any other material that the U.S. Nuclear Regulatory Commission, pursuant to the provisions of section 51 cf the Atomic Energy Act of 1954, as amended, determines to be special nuclear material, but does not include source material: or, (2) Any material artificially enriched by any of the foregoing but does cot include source material.
"Special nuclecr materialin quantities not sufficient to form a critical mass" means uranium enriched in the isotope U-235 in quantities not exceeding 350 grams of contained U-235:
uranium-233 in quantities not exceeding 200 grams; plutonium in quantities not exceeding 200 grams; or any combination of them in accordance with the following formula: For each kind of special nuclear material, determine the ratio between the quantity of that special nuclear material and the quantity specified above for the same kind of special nuclear material. The sum of such ratios for all of the kinds of special nuclear materialin combination shall not exceed 1. For example, the following quantities in combination would not exceed the limitation and are within the formula: 175(orams contained U-235) + 50(orams U-233) + 50(orams Pu) = 1 l 350 200 200 All Supp.1
i
- Survey
- means an evaluation cf tha radiclogical conditions and potential ha:*ards incident to the production. uss, transf:r, rsicase, dispo;al, er ;
presence of sources of radiation. When appropriate, sud evaluation includes, but is not limited to, tests, physical examinations, and measurements of levels of radiation or concentrations of radioactive material present.
, " Teletherapy" means therapeutic irradiation in which the source of radiation is at a distance-from the body. ;
i i
" Temporary jobsite" means any location where a portable source of radiation is l
used or stored, other than a location listed in a specific license or i registration, for a period of no longer than 365 continuous days. !
" Test" means the process of verifying compliance with an applicable regulation.
"These regulations" mean all parts of CCamR 26.12 " Radiation Management".
" Total effective dose equivalent" [ See " Dose") {
" Total organ dose equivalent" ( See " Dose")
"U.S.
Department of Energy" means the Department of Energy established by' Public Law 95-91, August 4, 1977, 91 Stat. 565, 42 U.S.C. 7101 et seq., to the , i extent that the Department exercises functions formerly vested in the U.S. Atomic Energy Comunission, its Chairman, members, officers and cosponents and ; transferred to the U.S. Energy Research and Development Administration and to j the Administrator thereof pursuant to sections 104 (b), (c) and (d) .of the , Energy Reorganization Act of 1974 (Public Law 93-438, October 11, 1974, 88 Stat.1233 at 1237, 42 U.S.C. 5814, effective January 19, 1975) and ! retransferred to the Secretary of Energy pursuant to section 301(a) of the ? Department of Energy Organization Act (Public Law 95-91, August 4, 1977, 91 : Stat. 565 at 577-578, 42 U.S.C. 7151, effective October 1, 1977.) '
" Unrefined and unprocessed ore" means ore in its natural form prior to any i processing, such as grinding, roasting, beneficiating, or refining.
" Unrestricted area" means any area, access to which is not limited by the i licensee or registrant. '
"Very high radiation area" means an area, accessible to individuals, in which :
radiation levels could resu'.t in an individual receiving an absorbed dose in ! excess of 5 Gy (500 rad) in 1 hour at 1 meter from a source of radiation or - from any surface that the radiation penetrates.3 I f
" Waste" means a radioactive material, or substance contaminated with !
radioactive material, that is useless and has no <tanwnstrated economic value. l In addition, the definition of waste shall include those radioactive wastes ! controlled under the low level Radioactive waste Policy Act, P.L. 96-573 as i amended by P.L. 99-240, effective January 15, 1986; that is, radioactive waste i (a) not classified as low-level radioactive waste, spent nuclear fuel, or l i 3 At very high doses received at high dose rates, units of absorbed dose, f gray and rad, are appropriate, rather than units of dose equivalent, sievert and rem. I i f
. . A12 !
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5
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byproduct material as defined in Section 11(e) (2) of the Atomiic Energy Act
- turaniust.or thoriumi tailings and waste) and (b) classified as low-level radic., active waste consistent with existing law and in accordance with (a) by ;
the U.S. Nuclear Regulatory Comunission. ;
" Waste handling licensees" mean persons licensed to receive and store t i
radioactive wastes prior to disposal and/or persons licensed to dispose of radioactive waste. _' t
" Week" means */ consecutive days starting on Sunday. i . " Weighting factor" (wT) for an organ or tissue (T) means the proportion of the risk of stochastic effects resulting frami irradiation of that organ.or tissue ,
to the total risk of stochastic effects when the whole body is irradiated ! uniformly. For calculating the effective dose equivalent, the values of W are: T ! t ORGAN DOSE WEIGITING FACERS l 1 Organ or
-Tissue l W.g l l
i ds 0.25 Breast 0.15 Red Bone Marrow 0.12 9 0.12 Thyroid
, 0.03 Bone Surfaces 0.03 !
Remainder 0.30" l Whole Body 1.00 b i 0.30 results from 0.06 for each of 5 " remainder organs, excluding the skin and the lens of the eye, that receive the highest dose. > b For the purpose of weighting the external whole body dose, for adding it to the internal dose, a single weighting factor, W =1.0 T has been specified. The use of other weighting factors for external exposure will be approved on a case-by-case basis until such time as specified guidance is issued.
"Whole ' body" means, for purposes of exterr.41 exposure, read, trunk including male gonads, arms above the elbow, or legs above the knee.
A13
" Worker" means an individual engaged in work under a license or registration issued by the A - controlled by a licensee or registrant, but does not include the licensee or registrant. " Working level" means any combination of short-lived radon daughters in I liter of air that will result in the ultimate emission of 1.3x105 MeV of potential alpha particle energy. 'Ihe short-lived radon daughters are-for radon-222: polonium-218, lead-214, bismuth-214, and polonium-214; and for radon-220: polonium-216, lead-212, bismuth-212, and polonium-212. " Working level month" (WLM) means an exposure to 1 working level for 170 hours-2,000 workin hours per year divided by 12 months per year is approximately equal to 170 hours per month. " Written directive" means an order in writing for a specific patient, dated and signed by an authorized user prior to the administration of a radiophamaceutical or radiation, or in the case of radiation from a radiation machine, by a physician, except as specified in paragraph (6) of this definition, containing following information: (1) For any administration of quantities greater than 30 microcuries of either sodium iodide I-125 or I-131: the dosage; (2) For a therapeutic administration of a radiopharmaceutical other than sodium iodide I-125 or 1-131: the radiopharmaceutical, dosage, and route of administration; (3) For gamma stereotactic radiosurgery: target coordinates, collimator size, plug pattern, and total dose; (4) For teletherapy: the total dose, dose per fraction, treatment site, and overall treatment period; (5) For high-dose-rate remote afterloading brachytherapy: the radioisotope, treatment site, and total dose; or (6) For all other brachytherapy: (i) Prior to implantation: the radioisotope, number of sources, and source strengths; and (ii) Atter implantation but prior to completion of the procedure: the radioisotope, treatment site, and total source strength and exposure time (or, equivalently, the total dose).
" Year" means the period of time beginning in January used to determine compliance with the provisi of these regulations. The licensee or registrant may change the starting date of the year used to determi compliance by the licensee or registrant provided that the change is made at the beginning of the yea that no day is omitted or duplicated in consecutive years.
Exemptions from the Regulatory Requirements Sec. A.3 Exemptions. (a) General Provision. The Agency may, upon application or upon its own initiative, grant such exemptions or exceptions from the requirements of these regulations as it determines are authorized law and will not result in undue hazard to public health and safety or property. Supp.1 A14
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l . . l (b) U.S. Deoartment of Enerry Contractors and U.S. Nuclear Rerulatory Commission Contractors. Any U.S. Depanment of Energy contractor or subcontractor and any U.S. Nuclear Regulatory Commission ,, contractor or subcontractor of the following categories operating within this State is exempt from thesu regulations to the extent that such contractor or subcontractor under his contract receives, possesses, uses, l transfers or acquires sources of radiation: l (1) prime contractors performing work for the U.S. Department of Energy at U.S. Government-owned or -controlled sites, including the transportation of sources of radiation to or from such sites and the performance of contract services during temporary interruptions of such transponation; (2) prime contractors of the U.S. Depanment of Energy performing research in, or development, manufacture, storage, testing, or transportation of, atomic weapons or components thereof; (3) prime contractors of the U.S. Department of Energy using or operating nuclear reactors or other nuclear devices in a United States Government-owned vehicle or vessel; and 4 I (4) any other prime contractor or subcontractor of the U.S. Department of Energy or of the U.S. Nuclear Regulatory Commission when the State and the U.S. Nuclear Regulatory Commission jointly determine: { (i) that the exemption of the prime contractor or subcontractor is authorized by law; and (ii) that under the terms of the contract or subcontract, there is adequaic assurance that the work thereunder can be accomplished without undue risk to the public health and safety. General Regulatory Requirements Sec. A.4 Recordt (a) Each person who is a licensee for the use of radioactive materials shall maintain records required by these regulations at the licensee's office in Maryland. If a licensee maintains more than one office in Maryland, he shall inform the Agency of the location of the office where required records will be maintained. (b) Each person responsible for a radiation machine facility shall maintain such records as required by these regulations at the facility where the radiation machine is located or stored. (c) Each licensee or registrant shall maintain records showing the receipt, inventory, transfer, and ' disposal of all sources of radiation (d) Addition.11 record requirements are specified elsewhere in these regulations. Sec. A.5 Insnections. (a) Each licensee and registrant shall afford the Agency at all reasonable times opponunity to inspect sources of radiation.the premises and facilities wherein such sources of radiation are used or stored. (b) Each licensee and registrant shall make available, upon inspection by the Agency, records maintained pursuant to these regulations. AIS Supp.1 i
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Sec. A.s Testa. Each licensee and registrant shall perform upon instructions { from the Agency, or shall permit the Agency to perform, such rs==r==hle tests . as the' Agency deems appropriate or necessary including, but not limited to, tests of: l i (a) sources of radiation; ;
}
(b)- I iacilities wherein sources of radiation are used or stored: * (c) radiation detection and monitoring instruments; and (d) other equipment and devices used in connection with utilization or storage of licensed or registered sources of radiation. , i a Additional Regulatory Requirements i Sec. A.7 Additinn=1 Reauir- =.tm. } order, 'Ehe Agency may, by rule, regulation, j license amendment or registrant condition, impose such requirements t upon any~ licenses / registrant above and beyond those established in these regulations as it deems health and safety appropriate or necessary to minimize danger to public or property. i Enforoament Requirements ! t Sec. A.a violations. An injunction or other court order may be obtained . prohibiting any violation of any provision of the Act or any regulation or l order issued thereunder. Any person who willfully violates any provision of { the Act or any regulation or order issued thereunder may be guilty of a , misdemeanor both, as provided and, by upon~ law.conviction, may be punished by fine or imprisonment or See. A.9 Y=normMna. pursuant to the Act, Sources of radiatica shall be subject to impounding > i See. A.10 Prohibited 13 men. i (a) A hand. held fluoroscopic screen using X-ray equipment shall not be used unless it has been listed in the Registry of Sealed Source and Devices or accepted for certification by the U.S. Food and Drug Administration, Center for Devices and Radiological Health. ; (b) .i A shoe-fitting fluntoscopic device shall not.be used.
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e A16 l I i I a ________.__I
j . ef the int rmation rsquircd by 'C.21(c) (3) . In th2 ctco whnre tha l transferee receives the depleted uranium pursuant to a general license contained in the U.S. Nuclear Regulatory Coasnission's_or
' Agreement State's regulation equivalent to C.21(e) (1) , the transferor shall furnish the transferee a copy of this regulation and a copy of the information required by C.21(a) (3) accompanied by a note explaining that use of the product or device is regulated by the U.S. Nuclear Regulatory Comunission or Agreement State under i
requirements substantially the same as those in this regulation; (iv) -within 30 days of any transfer, shall report in writing to the Agency the name and address of the person receiving the depleted j I uranium pursuant to such tranafer; and ! lv) 'shall not export such depleted uranium except in accordance i with a license issued by the U.S. muelear Regulatory Conunission , pursuant to 10'CFR Part 110. (5) Any person receiving, acquiring, possessing, using, or tranaferring depleted uranium pursuant to the general license established by i C.21 (e) (1) is exaspt from the requirements of Parts D and J of these i regulations with respect to the depleted uranium covered by that general j license. i 1 Bee. C.22 Ganaral LI*nmee* - endioactive Material Other Than Source . untarial. l } (a) Ceremin Devicae ==a u,m4n==at. A general license is hereby issued to I transfer, receive, acquire, own, possess, and use radioactive material i incorporated in the following devices or equipment which have been manu-factured, tested and labeled by the manufacturer in accordance with a specific ! license issued to the manufacturer by the U.S. Nuclear Regulatory Comunission for use pursuant to Section 31.3 of 10 CFR Part 31. This general' license is & subject to the provisions of A.4 through A.9, C.4 (a) (2) , C.31, C.40, C.50 and j Parts D 1/, 4, and T of these regulations. (1) statir u14=4n=elen nevice. Devices designed for use as static i i eliminators which contain, as a sealed source or-sources, radioactive material consisting of a total of not more thar 500 microcuries (18.5 }- MBq) of polonium 210 per device. i j (2) Ian Generatino Tube. Devices desi ] contain, as a sealed source or sources,gned for ionization radioactive materialofconsituing air which
- of a total of not more than 500 microcuries (18.5 MBq) of polonium-210 1
' per device or a total of not more than 50 millicuries (1.85 GBq) of 4 hydrogen-3 (tritium) per device. l l
- note: Different general licenses are issued in this section, each of which has its own specific conditions and requirements.
-i/ Attention is directed particularly to th$ provisions of Part D of these regulations which relate to the labeling of containers.
I l l C11
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(b) Reserved { 4' i (c) Reserved I !- i ! (d) Certain M*==rine. Gaurine or Controlline Devices. ! i j' (1) A general license is hereby issued to commercial and industrial firms and to research.
~
- educational and medical institutions, individuals in the conduct of their business, and State or i l local government agencies to own, receive, acquire, possess, use or transfer in accordance with l i the provisions of C.22(d)(2), (3),'and (4), radioactive material, excluding special nuclear l material, coprainal in devices designed and manufactured for the purpose of detecting, l l measuring, gauging or controlling thickness, density, level, 'mterface location, radiation, leakage, l
- or qualitative or quantitative chemical composition, or for producing light or an ionized ;
i atmosphere. (2) 'Ihe general license in C.22(d)(1) applies only to radioactive material contained in devices which have been manufactured and labeled in accordance with the specifications contained in a specific license issued by the Agency pursuant to C.28(d) or in accordance with the specifications ; contained in a specific license issued by the U.S. Nuclear Regulatory Commission, an Agreement l State or a Licensing State, which authorizes distribution of devices to persons generally licensed i by the U.S. Nuclear Regulatory f'a==inuion, an Agreement State or a Licensing State and the : device has been manufactured and installed so that: I
- 0) The done rate in the radiation beam of the device at 18 inches (0.46 meters) from the radiatior. aource with the device shutter in the open poshion does not exceed 125 millirem ;
(1.25 mSv) per hour; and ; e i
- 01) 1here is not an accessible airgap of 18 inches (0.46 meters) or greater between the !
radiation source and detector which would allow 'msertion of a 12 inch (0.30 meters) . l diameter sphere into the radiation beam 5/. 6 (3) Any person who owns, receives, acquires, possesses, uses, or transfers radioactive material in a device pursuant to the general license in C.22(d)(1): f
- 0) shall assure that all labels affixed to the device at the time of receipt, and bearing a 5 statement that removal of the label is prohibited, are mamtminal thereon and shall comply ,
with all instructions and precautions provided by such labels; r
- 01) shall assure that the device is tested for leakage of radioactive material and proper ;
operation of the "on-off mechanism and. indicator, if any, at no longer than 6-month ' intervals or at such other intervals as are specified in the label, however, i 5/ Regulations under the Federal Food, Drug, and Cosmetic Act authorizing the use of radioactive control . devices in food production require certain additional labeling thereon which is found in 21 CFR 179.21. ! i C12 i Supp.1 r i
a (7) th7 cnvironmental riport, if r quired by tha Ag:ncy und2r C.25 (b) , io cec:ptabic. (B) The radioactive material being licensed is not an isotope of Cesium for the use or storage in a liquid or water environment. (b) In the case of an application for a license or amendment to an existing license to receive and possess radioactive material for the conduct of any activity which the Agency determines will significantly affect the quality of the environment, the applicant shall prepare an environmental report. The report shall address the environmental, economic, technical and other benefits against environmental costs considering available alternatives, with any appropriate conditions to protect environmental values. Commencement of 4 construction prior to such conclusion shall be grounds for denial of a license to receive and possess radioactive material in such plant or facility. As used in this paragraph the tenn " commencement of construction" means any clearing of land, excavation, or other substantial action that would adversely affect the environment of a site. The term does not mean site exploration, necessary roads for site exploration, borings to determine foundation conditions, or other preconstruction monitoring or testing to establish background information related to the suitability of the site or the protection of environmental values. (c) Each specific license application shall contain a provision for an emergency plan as specified in C.23. , Sec. c.26 Soecial Recuirements for Issuance of certain Soecific Licenses for ! i Radioactive Material. 1 (a) - (d) B.rapIy.t.d. (e) Use of Sealed Sources in Industrial Radioorachv. In addition to the requirements set forth in C.25, a specific license for use of sealed sources l in industrial radiography will be issued if: (1) the applicant will have an adequate program for training t radiographic personnel and submits to the Agency a schedule or I description of such program which specifies the: l (i) initial training, (ii) periodic training, (iii) on-the-job training, and (iv) means to be used by the liennsee to determine the radiographic personnel's knowledge and understanding of and ability to comply with Agency regulations and licensing requirements, and the operating and emergency procedures of the applicant.
- 12) the applicant has established and submits to the Agency satisfactory written operating and emergency procedures described in E.202 of these regulations; (3) the applicant will have an internal inspection system adequate to assure that these regulations, license provisions, and the applicant's operating and emergency procedures are followed by radiographic personnel; the inspection system shall include the performance of
. internal inspections at intervals not to exceed 3 months and the retention of records of such inspections for 2 years; (4) the applicant submits to the Agency a description of the overall organizational structure pertaining to the industrial radiography C25
program, . including specified delegations of authority and responsibility for operation of the program; (5)' the applicant who desires to conduct his own leak tests has established adequate procedures to be followed in testing sealed sources for possible leakage and contamination and submits to the Agency a description o. f such procedures including: (1) instrumentation to be used, (ii) method of performing tests, and (iii) pertinent experience of the individual who will perform the test; and (6) the licensee shall conduct a program for inspection and maintenance of radiographic exposure devices and storage containers important to to safety. assure proper functioning of components (f) Soecific Licenses for Irradiators. (1) The applicant shall satisfy the general requirements specified this part.in Section C.25 and the requirements contained in (2) The application must describe the training provided to irradiator operators including: (i) Classroom training; (ii) On-the-job or simulator training; (iii) Safety reviews; (iv) Means employed by the applicant to test each operator's understanding of these regulations and licensing requirements and the irradiator operating and emergency procedures; and (v) Minimam t. raining and experience of personnel who may provide trair.ing. (3) The application must include an outline of the written operating and emergency procedures listed in Section X.53 that describes the radiation safety aspects of the procedures. Supp.1 C26 k
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i l (4) The application must describe the organizational j i structure for managing the irradiator, specifically the ! i radiation safety responsibilities and authorities of the ! radiation safety officer and those management personnel-who I have important radiation ~ safety responsibilities or authori- ! ties. In particular, the application must specify who, i within the management structure,-has ths authority to stop l !. unsafe operations. The application must also describe the
- training and experience required for the position of {
radiation safety' officer. i l
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(5) The application must include a description of the access ! control systems required by Section X.23, the radiation i i- ' monitors required by Section X.29, the method-of detecting l leaking sources required by Section X.59 including the ! e sensitivity of the method, and a diagram of the facility j
- that shows the locations of all required interlocks and ;
i radiation monitors. I
- h (6) If the applicant intends to perfctm leak testing of dry- l
- source-storage sealed sources, the applicant shall establish .;
j procedures for leak testing and submit a description of j these procedures to the Agency. The description must
- include the
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- (i) Instruments to be used; f
(ii) Methods of performing the anklysis;'and l (iii) Pertinent experience of the. individual who analyzes the samples. ); r i (7) If licensee personnel are to load or unload sources, the I l applicant shall describe the qualifications and training of the personnel and the procedures to be used.- If the applicant intends to contract for source loading or j unloading at its facility, the loading or-unloading must be ; i done by an organization specifically authorized by the l [ Agency, an agreement State or the NRC to load or unload ! ! irradiator sources. l j = i (8) The applicant shall describe the inspection and l ! maintenance checks, including the frequency of the checks ; i required by Section X.61.Sec. C.26 Special Requirements for i Issuance of Certain Specific Licenses for Radioactive '.
- Material.
4 b ? 3- } j C26-1 Supp.1 l I I i i i
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Sec. C.27 Soecial Reauirements for Snecific Licenses of Broad Scope. .This section prescribes requirements for the issuance of ( specific, licenses of. broad scope for radioactive material and ; certain regulations governing holders of such licenses.1/ ! (a) The different types of broad scope licenses are set forth { below: ' (1) A " Type A specific license of broad scope" is a specific ! license authorizing receipt, acquisition, ownership, possession,.use and transfer of any chemical or physical i j form of the radioactive material specified in the license, but not exceeding quantities specified in the license, for ; any authorized purpose. The quantities specified are j usually in the ! multicurie range. i (2) A~" Type B specific license of broad scope" is a~ specific license authorizing receipt, acquisition, ownership, f possession, use and transfer of any chemical or physical j form of radioactive material specified in Appendix D of this part, for any authorized purpose. The possession limit for l a Type B license of broad scope, if only' one radionuclide is ! possessed thereunder, is the quantity specified for that- ! radionuclide in Appendix D, Column I. If two or more ! radionuclides are possessed thereunder, the possession limit i for each is determined as follows: For each radionuclide, determine the ratio of the quantity possessed to the applicable quantity specified in Appendix D, Column I, for that radionuclide. The sum of-the ratios for all ! radionuclides possessed under the license shall not exceed ' unity. ,
.i 1/ Authority to transfer possession or control by the 1 manufacturer, processor, or producer of any equipment, device, -
commodity, or other product containing byproduct material whose subsequent possession, use, transfer, and disposal by all other persons are exempted from regulatory requirements may be obtained- i only from the U.S. Nuclear Regulatory Commission, Washington, ! D.C. 20555. ,
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IIboratori:s or hospitals and only for jn yltr.2 clinical or !!,boratory tests not involving internal or extemal administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use, and transfer are subject to the regulations and a general license of a Licensing State. Name of manufacturer (5) the label affixed to the unit, or the leaflet or brochure which accompanies the package, contains adequate information as to the precautions to be observed in handling and storing such radioactive material. In the case of the Mock lodine-125 reference or calibration source, the information accompanying the source must also contain directions to the licensee regarding the waste disposal requirements set out in D.1001 of these regulations. (i) Licensina the Manufacture and Distribution of Ice Detection Devices. An application for a specific license to manufacture and distribute ice detection devices to persons generally licensed under C.22(j) will be approved if: (1) the applicant satisfies the general requirements of C.25; and (2) the cnteria of Sections 32.61, 32.62. and 32.103 of 10 CFR Part 32 are met. (j) Manufacture and Distribution of Radiocharmaceuticals Containina Radioactive Material for Medical Use. An application for a specific license to manufacture and distribute radiopharmaceuticals containing radioactive material for use by persons licensed pursuant to this part for the uses listed in G.29, G.31, and G.35 of these regulations will be approved if: (1) the applicant satisfies the general requirements specified in C.25 of this part; (2) the applicant submits evidence that: (i) the adiopharmaceutical containing radioactive material will be manufactured, labeled, and packaged in accordance with the Federal Food, Drug and Cosmetic Act
- or the PuMic Health Service Act, such as a n.ew drug application (NDA) approved by the Food and Drug Administration (FDA), or a " Notice of Claimed Investigational Exemption for a New Drug" (IND) that has been accepted by the FDA, or (ii) the mariuf acture and distribution of the radiopharmaceu*;ni - containing radioactive material is not subject to the Federal Food, Drug and Cosmetic Act and the Public Health Service Act; (3) the applicant submits information on the radionuclide, chemical and physical form, packaging including maximum activity per package, and shielding provided by the packaging of the radioactive material which is appropriate for safe handling and storage of radiopharmaceuticals by group licenseos; and (4) (i) the label affixed to each package of the radiopharmaceutical contains information on the radionuclide, quantity, and date of assay and the label affixed to each package, or the leaflet or brochure which accompanies each package, contains a statement that the radiopharrnaceutical is licensed by the Agency for distribution to persons licensed pursuant to this part for the uses listed in G.29, G.31, snd G.35 of these regulations 4 or under equivalent C37 Supp.1 1
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I
=
l lictncas of tha U.S.'Nuclocr R3guletory Commiccion, an l Agratment Stete, or c Licznsing State. (ii) the labels, leaflets, or brochures required by C.28 (j) (4) (i) are in addition to the labeling required by the Food and Drug Administration (FDA) and they may be separate from or, with the approval of FDA, may be combined with the labeling required by FDA. j (k) Manufacture and Distribution of Generators or Reaaent Kits for Preparation ! of Radionharmaceuticals Containina Radioactive Material.12/ An application for a specific license to manufacture and distribute generators or reagent kits containing radioactive material for preparation of radiopharmaceuticals by persons licensed pursuant to this part for the uses listed in G 31 of these , regulations will be approved if. I (1) the applicant satisfies the general requirements speriiied in C.25; (2) the applicant submits evidence that: (1) the generator or. reagent kit is to be manufactured, labeled and packaged in accordance with the Federal Food, Drug and Cosmetic Act or the Public Health Service Act, such as a new drug application (NDA) approved by the Food and Drug Administration (FDA) , or a s
" Notice of Claimed Investigational Exemption for a New Drug" (IND) '
that has been accepted by the FDA, or > (ii) the manufacture and' distribution of the generator or reagent kit are not subject to the Federal Food, Drug and Cosmetic Act and the Public Health Service Act; (3) the applicant submits information on the radionuclide, chemical and physical form, packaging including maximum activity per package, and shielding provided by the packaging of the radioactive material contained i in the generator or reagent kit; (4) the-label affixed to the generator or reagent kit contains information on the radionuclide, quantity, and date of assay; and 7 (5) the label affixed to the generator or reagent kit, or the leaflet or brochure which accompanies the generator or reagent kit, contains: (i) adequate information, from a radiation safety standpoint, on the procedures to be followed and the equipment and shielding to be used in eluting the generator or processing radioactive material with the reagent kit, and (ii) a statement that this generator or reagent kit, as appropriate, is approved for use by persons licensed by the Agency pursuant to G.31 of these regulations or under equivalent licenses of the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State. The labels, leaflets, or brochures required by C.28 (k) are in addition to the labeling required by *the Food and Drug ! Administration (FDA) and they may be separate from or, with the approval of FDA, may be combined with the labeling required by FDA. i 12/ Although the Agency does not regulate the manufacture and distribution of reagent kits that do n,t contain radioactive material, it does regulate the use of such reagent kits for the preparation of radiopharmaceuticals containing radioactive material as part of its licensing and regulation of the users of radioactive material. Any manufacturer of reagent kits that do not contain radioactive material who desires to have his reagent kits approved by , the .Tgency for use by persons licensed pursuant to G.31 of these regulations , may arbmit the pertinent information specified in C.28 (k) . > l C38
e WASTE DISPOSAL Sec. D 1001 General Recuirement. No licensee shall dispose of any radioactive material except:
- a. By transfer to an authorized recipient as provided in D.1007 and C.40 of these regulations, or
- b. As authorized pursuant to D.301, D.302, D.1002, D.1003, D.1005, or D.1006
- c. Not withstanding the provisions of D.1001 a and b, the Agency may prohibit by rule, regulation or order any transfer or disposal of radioactive material.
Sec. D.1002 Method of Obtainino Aceroval of Procesed Discosal Procedures. Any person may apply to the Agency for approval of proposed procedures to dispose of radioactive material in a manner not otherwise authorized in this part. Each application shall include a description of the radioactive material, including the quantities and kinds of radioactive material and levels of radioactivity involved, and the proposed manner and conditions of disposal. The application, where appropriate, should also include an analysis and evaluation of pertinent information as the nature of the environment, including topographical, geological, meteorological, and hydrological characteristics; usage of ground and surface waters in the general area; the nature and location of other potentially affected facilities; and procedures to be observed to minimize the risk of unexpected or hazardous exposures. Sec. D.1003 Discosal by Release into Sanitary Sewerace,
- a. No licensee shall discharge licensed material into sanitary sewerage unless each of the following conditions is satisfied,
- i. The material is readily soluble, or is a readily dispersible biological material, in water; and ii. The quantity of licensed or other radioactive material that the licensee releases into the sewer in 1 month divided by the average monthly volume of water released into the sewer by the licensee does not exceed the concentration listed in Table III of Appendix B; and D29 e 8
._ _ _ _ _ _ _ _ _ _ . _ . _ . _ _ . ~ . _ _ _ _ . _ _ _ _ _ _ , . . _ _ . . . _ _ - -
e
- iii.
If mrra than one rzdionuclida is rais: sed, the following conditions must also be ' satisfied. . f t (1) I The licensee shall determine the fraction of the limit in Table lit of : appendix B represented by discharges into sanitary sewerage by dividing i the actual monthly average concentration of each radionuclide released by the licensee into the sewer by the concentration of that radionuclide t listed in Table til of Appendix B; and (2) The sum of the fractions for each radionuclide required by D.1002a.iii. (1) does not exceed unity; and t iv. i The total quantity of licensed and other radioactive material that the licensee i releases into the sanitary sewerage in a year does not exceed 185 GBq (5 Cil i of hydrogen-3, 37 GBq (1 Ci) of carbon-14, and 37 GBq (1 Ci) of all other y radioactive materials combined.- '
- b. i Excreta from individuals undergoing medical diagnesis or therapy with radioactive material are not subject to the limitations contained in D.1003a.
Sec. D.1004 RESERVED Sec. D.1005 Trsei...ent or Disoosal bv indnar tion. No licensee shell treat or dispose of licensed material by incineration except for materials listed under Sec. D.1006 'or an i specifically approved by the Agency pursuant to Sec. D.1002. ' Sec. D.1008 Dianasa! of Soecific Wastes. I
- a. -
t Any licensee may dispose of the following radioactive material without regard to its radioactivity: .
*j i.
0.05 microcurie (1.85 kBq) or less of hydrogen 3, or carbon-14 per gram of medium used for liquid scintillation counting, and 11 . 0.05 microcurie (1.85 kBq) or less of hydrogen-3, or carbon-14 per gram of animal tissue averaged over the weight of the entire animal; provided, however, tissue may not be disposed of under D.1006 in a manner that would permit its use either as food for humans or as animal feed. 4 b. Nothing in D.1006(a), however, relieves the licensee of maintaining records showing the receipt, transfer and disposal of such radioactive material as specified in A.4 or these regulations. ' c. Nothing in D.1006(a) relieves the licensee from complying with other applicable federal, state, and local regulations governing any other toxic or hazardous property of these materials. Supp.1 ! D30 ' 1 i l
i Sec. D.1007 Transfer for Disoosal and Manifgits.
- a. . The requirements of D.1007 are designed to control transfers of low-level l radioactive waste intended for disposal at a licensed lo w-level radioactive waste j disposal facility, establish a manifest tracking system, and supplement existing i j requirements concerning transfers and recordkeeping for those wastes. j d
- b. The above requirements shall be conducted in accordance with - the l requirements in Appendix D and E to this Part.
i i ! Sec. D.1008 Comohnce with Environmental and Health Protection Reoulations.
- Nothing in Part D relieves the licensee or registrant from complying with other ;
l applicable Federal, State and local regulations governing any other toxic or hazardous i properties of materials that may be disposed of pursuant to Part D. ! J l RECDRDS l
- Sec. D.1101 General Provisions. :
l
- a. Each licensee or registrant shall use the Si units: becquerel, gray, sievert and coulomb per kilogram, or the special units curie, disintergrations per minute, rad, rem and roentgen, including multiples and subdivisions, and shall clearly indicate the units of all quantities on records required by Part D.
- b. The licensee or registrant shall make a clear distinction among the quantities entered on the records required by Part D, such as, total effective dose equivalent, total organ dose equivalent, shallow dose equivalent, eye dose equivalent, deep dose equivalent, or committed effective dose equivalent.
Sec. D.1102 Records of Radiation Protection Proorams,
- a. Each licensee or registrant shall maintain records of the radiation protection program, including:
- 1. The provisions of the program; and ii. Audits and other reviews of program content and implementation.
- b. The licensee or registrant shall retain the records required by D.1102a.i. until the Agency terminates each pertinent license or registration requiring the record. The licensee or registrant shall retain the records required by D.1102a.ii. for 3 years after the record is made.
I D31 Supp.1 i
_ . . . _ . . , . . . . _ ._ . _ _ __ _ _ _ . _ _ _ _ - . . _ . - . . _ . _ _ . . _ . . . _ . _ - . .. .-. m. o Bee. D.1103 Records of Surveva, i
- a. Each licensee or registrant shall maintain records showing the results of l surveys and calibrations required by D.501 and D.906b. The licensee or registrant shall retain these records for 3 years after the record is made. f l
- b. The licensee er registrant shall retain each of the following recorda until the Agency terminates each pertinent license or registration requiring the !
record:
- 1. Records of the results of surveys to determine the dose from external I sources of radiation used, in the absence of or in combination with -
individual monitoring data, in the assessment of individual does j equivalents; and j
- 11. Records of the results of measurements and calculations used to determine individual intakes of radioactive material and used'in the assessment of internal dose; and 111. Records showing the results of air sampling, surveys, and bioassays required pursuant to D.703a.iii. (1) and (2) ; and- ,
1 I iv. Records of the results of measurements and' calculations used to ' evaluate the release of radioactive affluents to the envi e nt. 9 Sec. D.1104 Records of Tests for T==lemas or cone ==4nmelon of **=l ed' em- c-s. Records of tests for leakage or contamination of sealed sources required by D.401 shall be kept ih units of becquerel or microcurie and maintained for
- inspection by the Agency or until the sealed source is transferred or disposed.
Sec. D.1105 Records of Prior Oer imatian=1 Da==.
- a. The licensee or registrant shall retain the rocc:cds of prior occupational dose and exposure history as spe",1fied in D.205 on Agency Form ND 216 or equivalent until the Agency terminates each pertinent license or registration requiring this record or for such time as-the Agency shall determine.
- b. The licensee or registrant shall retain records used in preparing Agency Form ND 216 or equivalent for 3 years after the record is made or for such time as the Agency shall determine.
CE2 l l
Sec. D.1209 Notifientians. Records and Renorts of W=='..T.S*- :: 2
- a. For a mindm* .* 4 ion:
- i. De licensee or registrant shall notify by telephone the Agency
- no later than the next calendar day aAer the discovery of the minadminientian ii. The Heaa= or registrant shall submit a written report to the Agency within 15 days after discovery of the mindministration. De written report must include the licanaa*'s or registrant's name; the prescribing physician's name; a brief hirion of the event; why the event occurred; the effect on the patient; what improvements are naaded to prevent recurrence; whether the Heaa=aa or registrant notified the patient, or the patient's responsible relative or guardian (this person wili be subaa=>antly referred to as "the patient" in this section), and if not, why not, and if the patient was notified, what information was provided to the patient; and actions taken to prevent recurrence. The report must not include the patient's name or other information that could lead to identification of the patient.
iii. De licensee or r@ = shall notify the referring physician and also notify the patient of the miandministration no later than 24 hours aAer its discovery, unless the referring physician personally informs the E+ -:--- or registrant althar that he will inform the patient or that, based on madical j::-4 rd, telling the patient would be harmful. He licensee or registrant is not required to notify the patient without first consulting the referring physician. If the referring physician or patient cannot be ranchad within 24 ) hours, the licansaa or registrant shall notify the patient as soon as possible thereafter. l ne licensee or registrant may not delay appropriate madical care for the patient, I including any nemmary remedial care as a result of the misadministration, because of i any delay in notification. ! iv. If the patient was notified, the licensee or registrant shall also furnish, within 15 days l after discovery of the mi==dminiarmtion, a written report to the patient by sending either: l l
- 1. A copy of the report that was submitted to the Agency; or l
- 2. A brief desciirion of both the event and the consequences as they may affect the patient, provided a entement is included that the report submitted to the Agency can be obtained from
- De after hours telephone number of the Agency Emergency Operations Unit is (410) 243-8700.
D41 Supp.1 -
~
i e
- tha licen:co er r:gictrant.
- b. Each licensee or registrant shall retain a record of each misadministration for five years. The record must contain the names of all individuals involved (including the prescribing physician, the patient, and the patient's referring physician), the patient's social security number or identification number if one has been assigned, a brief description of the misadministration, why it occurred, the effect on the patient, what improveronts are needed to prevent recurrence, and the actions taken to prevent 7 securrence,
- c. Aside from the notification requirement, nothing in this section affects any rights or duties of licensees or registrants and physicians in relation to each other, patients, or the patient's responsible relatives or guardians.
ADDITIONAL REQUIREMEWIS Sec. D.1301 Vacatino Premises. (See also C.32, " Expiration and Termination of Licenses") Each specific licensee shall, no less than 30 days before vacating or relinquishing possession or control of premises or other authorized use location which may have been contaminated with radioactive material as a result of his activities, notify in writing of intent to vacate and submit a written decontamination survey to the Agency. When deemed necessary by the Agency, the licensee shall decontaminate the premises in such a manner as the Agency may specify. D42 1
4 . ?- 3 4 PART E I RADIATICH SAFRTY REQUIREMEIFFS FOR 4 INDUSTRIAL'RADIOGRAPRIC OPERATICBS I see. E.1 Purnome. The regulations in this part establish radiation safety requirements.for using sources of radiation for industrial radiography. The requirements of this part are in addition to, and not in substitution for, other applicable requirements of these regulations. see. E.2 Scone. The regulations in this part apply to all licensees or registrants who use sources of radiation for industrial radiography. Except for those regulations of this part clearly applicable only to sealed radioactive sources, both radiation machines and sealed radioactive sources are covered by this part. sec. E.3 Definitiana. As used in this part, the following definitions apply:
" Cabinet radiography" means industrial radiography conducted in an enclosure or cabinet shiol.ded so that radiation levels at every location on the exterior meet the lirications specified in D.301 of these regulations.
" Cabinet n-ray system" means an x-ray system with the x-ray tube installed in an enclosure independent of existing architectural structures except the floor on which it may be placed. The cabinet x-ray system is intended to contain at least that portion of a material being irradiated, provide radiation attenuation, and exclude personnel from its interior during generation of radiation. Included'are all x-ray systems designed primarily for the
' inspec': ion of carry-on baggage at airline, railroad, and bus terminals, and in similar facilities. An x-ray tube ased within a shielded part of a building, or x-ray equipment which may temporarily or occasionally incorporate portable shieldir:g, is not. considered a cabinet x-ray system.
" Certified cabinet x-ray system" means an x-ray system which has been certified in accordance with 21 CFR 1010.2 as being manufactured and assamhied pursuant to the provisions of 21 CFR 1020.40 "Collimator" means a device used to limit the size, shape, and direction of the primary radiati'.in beam.
" Industrial radiogrrphy" means the examination of the macroscopic structure of materials by nondestntetive aethods using sources of ionizing radiation to produce radiographic images.
'Lixiscope", means a portable light-intensified imaging device using a sealed source.
" Permanent radiographic installation" means an installation or structure designed or intended for radiography and in which radiography is regularly performed conditions applies:
for a period of more than 90 days and at which any of the following E1
__m._._ _._ .... _ _ _ _ _ _ _ . _ . _ _ _ _ _ _ _ _ _ _ _ . _ _ . . _ _ . , i
- a. .. Telephone service is established by the licensee; ,
- b. Industrial radiographic services are advertised for or from the locat'on; or i
1
- c.
- Industrial radiographic operations are conducted at other sites due to arrangements made j from the location. '
)
i
" Personal supervision" means guidance and instruction provided to a radiographer trainee by a- {
radiographer instructor who is present at the site, in visual contact with the trainee while the trainee is ' using sources of radiation, and in such proximity that inn =tiate assistance can be given if required. l
" Radiographer" manen any individual who performs or personally supervises industrial radiographic ;
operations and who is responsible to the licensee or registrant for assuring compliance with the j requirements of these regulations and all license and/or certificare of registration conditions. ;
" Radiographer 1-u ciur" mencs my radiographer who has been authorized by the Agency to provide
{' on-the-job training to radiograpt 4ainees in accordance with E.201(b)(2). t
" Radiographer trainen" means any individual who, under the personal supervision of a radiographer instructor, uses sources of radiation, related handl* m g tools, or radiation survey instruments during the ,
course of his instruction. i
" Radiographic exposure device" means any instrument containing a sealed source fastened or containari )
therein, in which the sealed source or shielding thereof may be moved, or otherwise changed, from a l' shielded to unshielded position for purposes of making a radiographic exposure. z.
" Radiographic person or personnel" means any radiographer, radiographer instructor, or' radiographer trainee.
- l "Resiriantial location" means any area where structures in which people lodge or live are located, and the t grounds on which such structures are located including, but not lismtad to, houses, apartments, l condominiums, and garages, i f
1
" Shielded position" manns the location within the radiographic exposure device or storage container l
which, by manufacturer's design, is the proper location for storage of the sealed source. ,
" Shielded-room radiography" manna industrial radiography conducted in a room shielded so that radiation levels at every location on the exterior meet the ihnitations specified in D.301 of these regulations. ;
" Source changer" means a device designed and used for replacement of sealed sources in radiographic exposure devices, including those source changers also used for transporting and storage of sealed sources. ,
" Storage area" manns any location, facility, or vehicle which is used to store, to transport, or to secure '
a radiographic exposure device, a streage contamer, or a sealed source when it is not in use and which : is locked or has a physical barrier e prevent accidental exposure, tampering with, or unauthorized i removal of the device, container, or scarce. j l
" Storage container" means a shielded device in which sealed sources are secured and stored. l Supp.1 E2
(c) Tha licsneca or registrcnt chall rsquiro that occh pockst dosimeter- ' 1 I (1) Shall have a range from zero to 200 milliroentgens (5.1C x 10~6 c/kg). ; i (2) Shall be calibrated at periods not to exceed one year such j that the dosimeter shall read within plus or minus 30 ; percent of the true radiation exoosure. Records of these j
- calibrations shall be maintained-for inspection by the Agency for 3 years from the date of the calibration.
4 l i ! (3) Shall be read and the exposures recorded at least once I daily; , j: 4 (4) Shall be recharged daily or at the start of each shift. ) i (d) If an individual's pocket dosimeter is discharged beyond its range, industrial radiographic operations by that individual shall cease and ! the individual's film badge or TLD shall be processed immediately. ; 4 The individual shall not return to work with sources of radiation + until a determination of the radiation exposure has been made. i i . (e) Reports received from the film badge or TLD processor and records of I } daily pocket dosimeter readings shall be kept for inspection by the l' Agency until the Agency authorizes disposition. l
- (f) If a film badge or TLD is lost or damaged, the worker shall cease work f i
immediately until a replacement film badge or TLD is provided and the l exposure is calculated for the time period from issuance to loss or ' 2 damage of the film badge or TLD. j Sec. E.204 Suoervision of Radicaracher Trainee. Whenever a radiographer ! i trainee uses radiographic exposure devices, sealed sources or related source j handling tools, or conducts radiation surveys required by E.303 (b) and (c) to ; { determine that the sealed source has returned to the shielded position after i an exposure, the radiographer trainee shall be under the personal supervision '
- of a radiographer instructor.
1 u . j Precautionary Procedures in Radiographic Operations ' E Sec. E.301 Sycurity. During each radiographic operation, s the radiographer, } radiographer instructor or radiographer trainee shall maintain a direct surveillance of the operation to protect against unauthorized entry into a ' f high radiation area, as defined in Part A of thase regulations, except: ' . (.) where the high radiation area is equipped'with a control device or l alarm system as described in D.601(a) (ii) of these regulations, or ! (b) where the high radiation area is locked to protect against j unauthorized or accidental entry. i i Sec. E.302 Postina. Notwithstanding any provisions in D.903 of these
} regulations, areas in which radiography is being performed shall be ;
j conspicuously posted as required by D.902 (a) and (b) of these regulations. l f i ! a ' E9 > 4
Sec. E.303 Radiation Surveys and Survey Records. (a) No radiographic operation shall be conducted unless at least one calibrated and operable radiation survey instrument, as described in E.104, is available and used by each radiographic person at the site of each exposure. (b) s A' survey with a radiation ' urvey instrument shall be made after each radiographic exposure to determine that the sealed source has been returned to its shicided position. The entire circumference of the radiographic exponae device shall be suiveyed. If the radiographic exposure device has a source guide tube, the survey shall also include the entire length of the guide tube. (c) A survey shall be made of the storage area as defined in E.3 whenever a radiographic exposure device is being placed in storage. (d) A physical radiation survey, as specified in E.102, shall be made to determine that each sealed source is in its shielded position prior to securing the radiographic exposure device, storage container, or source changer in a storage area as defined in E.3. (e) A physical radiation survey shall be made after each radiographic exposuir using radiation machines to determine that the machine is "off". i (f) Records shall be kept of the surveys mquired by E.303(c) and (d). Snch records shall l be maintained for inspection by the Agency for 2 years after completion of the survey. ! If the survey was used to determine an individual's exposure, however, the records of j the survey shall be maintained until the Agency authorizes their disposition. l Sec. E.304 Documents and' Records Reauired at Temoorary Jobsites. Each licensee or ! registrant conducting industrial radiography at a temporary jobsite shall have the following' i records available at that site for inspection by the Agency. 1 (a) appropriate license or certificate of registration or equivalent document, i L (b) operating and emergency procedures; (c) applicable regulations; , (d) survey records required pursuant to E.303 and area survey records required pursuant to - D.1103(a) of these regulations for the period of operation at the site; (e) daily pocket dosimeter records for the period of operation at the site; and (f) the latest instnament calibration and leak test records for specific devices and scaled j sources in use at the site. Acceptable records include tags or labels which are affixed ' to the device or survey meter. Supp.1 E10
L
' f i
h E.305 Soecific Reauirements for RndirEs JJe Personnel Perfonnine Industrial ~
.- Radiceraphy.
(a) At a jobsite, the following shall be supplied by the licensee or mgistrant:
- (1) at least one operable, calibrated survey instrument for each radiographic person; (2) A curmnt whole body personnel monitor (TLD or film badge) for each individual; ;
(3) an operable, calibated pocket dosimeter with a range of 0 to 200 milliroentgens ; (5.16 x 104 C/kg) for each radiographic person; (4) . an alarming ratemeter for each radiographic person; and (5) the appropriate barrier ropes and signs. i (b) Industrial radiographic operations shall not be perfonned if any of the items in l E.305(a) are not available at the jobs' ~ are inoperable. , (c) Each licensee or registrant shall provide as a minimum two radiographic personnel when sources of radiation are used at tempomry jobsites. If one of the personnel is a radiographer trainee, the other shall be a radiographer instructor. (d) No individual other than a radiographer or a radiographer trainee who is under the ; personal supervision of a radiographer instructor shall manipulate controls or operate equipment used in industrial radiographic operations. (e) No individual shall act as a radiographer instructor unless such individual: (1) has met the requirements of E.201(b); (2) has 1 year of documented experience as a radiographer. (f) During an inspection by the Agency, the Agency inspector may terminate an operation if any of the items in E.305(a) are not available and operable or if the required number of radiographic personnel are not present. Operations shall not be resumed until such conditions are met. Sec. E.306 Soecial Reauirements and Exemotions for Cabinet Radiography. (a) Systems for cabinet radiography designed to allow admittance of individuals shall: (1) Comply with all applicable requirements of this part and D.301 of these regulations. If such a system is a certified cabinet x-ray system, it shall comply with all applicable requirements of this part and 21 CFR 1020.40. E11 Supp.1 e
- r
_ - _ -. . ~ -- - -- ---- -- " ~ - -~ ~ ' ~" l (2) . Be evaluated ct intcrvalo not to cxeced 1 year to cccura i compliance with the applicablo requirement 3 as specificd in E.305 (a) (1) . Records of these evaluations shall be
- maintained for inspection by the Agency for a period of 3 years after the evaluation.
(b) Certified cabinet x-ray systems designed to exclude individuals from the interior of the cabinet are exempt from the requirements of.this part except that: (1) Operating personnel antst be provided with either a film badge j or a thermoluminescent dosimeter, and reports of the results shall be maintained for inspection by the Agency. 1 1 (2) No registrant shall permit any individual to operate a cabinet x-ray system until such individual has received a copy of and instruction in the operating procedures for the unit and has riamtvistrated competence in its use. Records ' which demonstrate compliance with this subparagraph shall be maintained for inspection by the Agency until disposition is I authorized by the Agency. l (3) Tests for proper operation of high radiation area control I devices or alarm systems, where applicable, shall be conducted, recorded, and maintained in accordance with E.109. (4) The registrant shall perform an evaluation, at intervals not to exceed 1 year, to determine conformance with D.301 of tacee regulations. If such a system is a certified cabinet , x-ray system, it shall be evaluated at intervals not to ! exceed 1 year to determine conformance with 21 CFR 1020.40. Records of these evaluations shall be maintained for i inspection by the Agen g for a period of 3 years
- after the evaluation.
(c) Certified cabinet x-ray' systems shall be maintained in compliance with 21 CFR 1020.40 unle'as prior approval has been granted by the 1 Agency purra. tant to A.3 (a) of these regulations.
- i Sec. E.307 Prohibitions. Industrial radiography performed with a sealed source which is not fastened to or contained in a radiographic exposure device, known as fishpols radiography, is prohibited unless specifically authorized in '
a license issued by the Agency. Sec. E.308 Safety Recuirements for Radih anhie Eauinment. 5 i (a) Radiographic exposure devices and associated equipment shall meet the criteria set forth by ANSI N432-1980. , (1) All newly manufactured radiographic exposure devices and - associated equipment acquired by licensees after September 1, 1993, i shall comply with the requirements of this part. , (2) All radiographic exposure devices and associated equipment in use E after January 1, 1996, shall comply with the requirements of this part. E12
Ug8 Mechanical Sunoort of Tube Head. Th3 tube hou ing cerembly cupporta ) ', chall be cdju tcd cuch that tha tube houzing cerembly will rcmain etable during an expo:uro un100a tube hou;ing movement io a de:ign d function cf tha x-rcy cyctem.
~
(h) Technicue Indicators. (1) The technique factors to be used during an exposure shall be indicated before the exposure begins. If automatic exoosure controls are used, the technique factors which are set prior to the exposure shall.be indicated. (2) The requirement of F4 (h) (1) may be met by permanent markings on equipment having fixed technique factors. Indication of technique factors shall be visiable from the operator's position except in the case of spot films made by the fluoroscopist. Sec. F.S Fluoresconic' X-Rav Systems Exceot for Comouted Tomocrachv X-Ray Systems. All fluoroscopic x-ray systems shall meet the following requirements: (a) Limitation of Useful Beam. (1) Primary Barrier. (i) The fluoroscopic imaging assembly shall be provided with a primary protective barrier which intercepts the entire cross section i of the useful beam at any SID. (ii) The x-ray tube used for fluoroscopy shall not produce x rays unless the barrier is in position to intercept the entire useful beam. l (2) X-Rav Field. (i) The x-ray field produced by non-image-intensified fluorescopic equipment shall not extend beyond the entire visible area of the image receptor. This requirement applies to field size for both fluoroscopic procedures and spot filming procedures. In addition: (g) means shall be provided for stepless adjustment of the field size; (b) the minimum field size at the greatest SID shall be equal to or less than 5 centimeters by 5 centimeters; (g) for equipment manuf actured af ter February 25, 1978, when the i angle between the image receptor and the beam axis of the x-ray beam l is variable, means sha*1 be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor; and (d) compliance with F.5 (a) (2) (i) shall be determined with the beam axis indicated to be perpendicular to the plane of the image receptor. (ii) For image-intensified fluoroscopic equipment, neither the length nor the width of the x-ray field in the plane of the image receptor shall exceed that of the visible area of the image receptor by more than 3 percent of the SID. The sum of the excess length and the excess width shall be no greater than 4 percent of the SID. In addition: (g) means shall be provided to permit further limitation of the field. Beam-limiting devices manufactured after May 22, 1979, and incorporated in equipment with a variable SID and/or a visible area of greater than 300 square centimeters shall be provided with mec7s for stepless adjustment of the x-ray field; F17 Supp.1
(b) cll cquipment with a fixed SID and a viciblo crcs cf 300 cquaro
- centimet:rc er loca chnll be provided with cith;r cttplOO3 cdju;tment cf tho x-rcy ficld or with means to furth;r limit tho x rcy fiold size at the plane of the image receptor to 125 square centimeters or -
less. Stepless adjustment shall, at the greatest SID, provide continuous field sizes from the maximum obtainable to a field size of 5 centimeters by 5 centimeters or less; (g) for equipment manufactured after February 25, 19*18, when the angle between the image receptor and beam axis is variable, means shall be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor; and (g) compliance shall be determined with the beam axis indicated to be perpendicular to the plane of the image receptor. For rectangular x-ray fields used with circular image reception, the error in alignment shall be determined along the length and width dimensions of the x-ray field which pass through the center of the visible area of the image receptor. (iii) Spot-film devices which are certified components shall meet the
~~
following additional requirements: (g) means shall be provided between the source and the patient for adjustment of the x ray field size in the plane of the film to the size of that portion of the film which has been selected on the spot film selector. Such adjustment shall be automatically accomplished except when the x-ray field size in the plane of the film is smaller than that of the selected portion of the film. For spot film devices manufactured after June 21, 1979, if the x-ray field size is less than the size of the selected portion of the film, the means for adjustment of the field size shall be only at the operator's option; (b) it shalt be possible to adjust the x-ray field size in the plane of the film to a size smaller than the selected portion of the film. The minimum field size at the greatest SID shall be equal to, or less than, 5 centimeters by 5 centimeters; (g) the center of the x-ray field in the plane of the film shall be aligned with the center of the selected portion of the film to within 2 percent of the SID; and (g) on spot-film devices manufactured after February 25, 1978, if the angle between the plane of the image receptor and beam anis is variable, means shall be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor, and compliance shall be determined with the beam axis indicated to be perpendicular to the plane of the image receptor. (g) spot film exposure control devices shall meet the time and exposure requirements of F.6. (iv) If e means exists to override any of the automatic x-ray field size adjustments required in F.5 (a) (2), that means: (a) shall be designed for use only in the event of system failure; (b) shall incorporate a signal visible at the fluoroscopist's l position which will indicate whenever the automatic field size I adjustment is overridden; and (g) shall be clearly and durably labeled as follows: FOR X-RAY FIELD LIMITATION SYSTEM FAILURE I i F18
L Part G USE OF RADIONUCLIDES IN THE HEALING ARTS 4 Sec. G.1 Purpose and Scope. This part establishes requirements and provisions for the use of radionuclides in the healing arts and for issuance of licenses authorizing the medical use of this material. These requirements and provisions provide for the protection of the public health and safety. The requirements and provisions of this part are in addition to, and not in substitution for, others in these regulations. The requirements and provisions of these regulations apply to applicants and licensees subject to , this part unless specifically exempted. , Sec. G.2 Definitions. As used in this part, the following definitions apply:
" Area of use" means a portion of a physical structure that has been a
set aside for the purpose of receiving, using, or storing radioactive material.
" Authorized user" means a practitioner of the healing arts who is identified as an authorized user on an Agency, Agreement State, Licensing State or U.S. Nuclear Regulatory Commission license that authorizes the medical use of radioactive material.
" Brachytherapy" means a method of radiation therapy in which sealed sources are utilized to deliver a radiation dose at a distance of up to a f ew centimeters, by surf ace, intracavitary, or interstitial application.
" Dedicated check source" means a radioactive source that is used to assure the constant operation of a radiation detection or measurement device over several months or years. This source may also be used for other purposes.
" Management" means the chief executive of ficer or that individual's designee.
" Medical institution" means an organization in which several medical disciplines are practiced.
" Medical use" means the intentional internal or external administration of radioactive material, or the radiation theref rom,
- to humans in the practice of the healing arts.
" Mobile nuclear medicine service" means the transportation and medical use of radioactive material.
G1 Supp.1 O O
i
" Output" means the exoomure rate, dose rate, or a. quantity related in a known manner to these rates from a teletherapy unit for a specified set of exposure conditions. ;
" Prescribed dosage" means the quantity of radiopharmaceutical activity as documented. j (1)
~
I In a written directive; or (2) Either in the manual or in any apprr.priate record in accordance with the directions of the authorized user for diagnostic procedures. i
" Recordable event" means the administration of:
(1) A radiopharmaceutical or radiation without a written ! directive where a written directive is required; ! (2) A radiopharmaceutical or radiation where a written : directive is required without daily recording of each administered ; radiopharmaceutical record; dosage or radiation dose in the appropriate !
}
(3) A radiopharmaceutical dosage greater than~30 microcuries : of either sodium iodide I-125 or I-131 when both: i (i) The administered dosage differs from the prescribed dosage by more than 10 percent of the prescribed dosage, and - (ii) The difference between the administered dosage and ! the prescribed dosage exceeds 15 microcuries;' l (4) A therapeutic radiopharmaceutical dosage, other than ! sodium iodide I-125 or I-131, when the administered dosage differs from the prescribed do~ sage by more than 10 percent of the prescribed dosage; (5) A teletherapy radiation dose when the calculated weekly administered dose; or dose is 15 percent greater than the weekly prescribed (6) A brachytherapy radiation dose when the calculated administered dose. dose differs by more than 10 percent of the prescribed
" Teletherapy physicist" means an individual identified as the
. qualified teletherapy physicist on an Agency license.
" Visiting authorized user" means an authorized user who 13 not identified on the license of the licensee being visited.
(The next page is G2) Supp.1 G1-1
General Regulatory Requirements ) Sec. G.3 License Reauired. ! (a) No person shall manufacture, produce, acquire, receive, possess, use, or transfer radioactive material for ! medical use except in accordance with a specific license issued pursuant to these regulations. l (b) Unless prohibited by license condition, an individual may receive, possess, use, or transfer radioactive : material in accordance with the regulations in this part under the supervision of an authorized user as provided in l G.10. Sec. G.4 License Amendmenis.. A licensee shall apply for and receive a license amendment: (a) Before using radioactive material for a method or ty;:e of medical use not permitted by the license issued under this part; (b) Before permitting anyone, except a visiting authorized user described in G.11, to work as an authorized user under the license; (c) Before changing a Radiation Safety Officer or Teletherapy Physicist; l (d) Before receiving radioactive material in excess of the amount authorized on the license, ; (e) Before adding to or changing the areas of use or address or addresses of use or storage identified in the ap slication or on the license; and ; 1 (f) Before changing statements, representations, and procedures which are incorporated into the license. Sec. G.5 Notifications. A licensee shall notify the Agency in writing within 30 days when an authorized user, Radiation Safety Of ficer, or Teletherapy Physicist, permanently discontinues performance of duties under the license. I Additional Requirements ] l Sec. G.6 ALAR A Procram. l (a) Each licensee shall develop and implement a written program to maintain radiation doses and releases of I radioactive material in effluents to unrestricted areas as low as reasonably achievable in accordance with D.1 of these regulations. To satisfy the requirement of G.6(a): (b)
)
(1) The management Radiation Safety Officer, and all authorized users shall participate in the ! establishment, implementation, and operation of the program as required by these regulations or the Radiation l Safety Committee; or i I (2) For licensees that are not medical institutions, management and all authorized users shall participate l in the program as required by the Radiation Safety Officer, j (c) The ALARA program shall include an annual review by the Radiation Safety Committee for licensees that are medical institutions,or management and the G2 Supp.1 l i 9 O
t Sec. G.59 Mafety Soot chacke for Teletharmnv Fadlitig. , , ! (a) A licensee shall promptly check all systems listed in G.57(g) for proper function after ! each installation of a teletherapy source and after making any change for which an amendment is required by G.49(a) through (d). { l 4 " (b) If the results of the safety spot checks required in G.59(a) indicate the malfunction of any system specified in G.57, the licensee shall lock the control console in the "off" position and not use the unit except as :nay be necessary to repair, replace, or check the malfunctioning system. 1 (c) A licensee shall maintain a record of the safety spot checks following inatallation of a ! source for 2 years. The record shall include notations indicating the operability of each entrance
- door interlock, each electrical or mechanical stop, each beam condition indicator light, the l viewing system, doors, and the signature of the Radiation Saferv Nficer.
j Sec. G.60 Modification of Telchernov Unifor Room Before. minnina a Trmtment Program. If the survey required by G.58 indicates that an individual in an unrestricted area may be exposed to levels of radiation greater than those permitted by D.301(a) of these regulations, l before beginning the treatment program the licensee shall: i (a) Either equip the unit with stops or add additional radiation shielding to ensure compliance j with D.301(a) of these regulations; . i ) (b) Perform the survey required by G.58 again; and - 1 j (c) Include in the report required by G.61 the results of the initial survey, a description of j l the modification made to comply with G.60(a), and the results of the second survey. Sec. G.61 Reoorts of Talatharaov Survevs. Chacks. Tests. and Maa<ii mmr.ta. A licensee shall .
)
! furnish a copy of the records required in G.58, G.59, G.60 and the output from the teletherapy l source expressed as rems (sieverts) per hour at 1 meter from the source as determined during ) the full calibration required in G.56 to the Agency within 30 days following completion of the i ; action that initiated the record requirement. l Sec. G.62 Five-Year In=nection. l j (a) A licensee shall have each teletherapy unit fully inspected and serviced during teletherapy souice replacement or at intervals not to exceed 5 years, whichever comes first, to assure proper j functioning of the source exposure mechanism. , (b) 'Ihis inspection and servicing shall only be performed by persons specifically 'icensed to i do so by the Agency, an Agreement State, or the U.S. Nuclear Regulatory Commission. i (c) A licensee shall maintain a record cf the inspection and servicing for the duration of the
' license. The record shall contain the inspector's name, the inspector's license number, the date of inspection, the manufacturer's name and model number and serial number for both the j teletherapy unit and source, a list of components inspected, a list of components serviced and the type of service, a list of components replaced, and the signature of the inspector. '
l' G27 Supp.1 a
l Sec. G.63 Radiation Safety Officer. Except as provided is G.64, an individual fulfilling the responsibilities ; of the Radiatiom Safety Officer as provided in G.7 shall: i
- i (a) Be certified by the
(1) American Board of Health Physics in Comprehensive Health Physics; (2) American Board of Radiology.in Radiological Physics, nerapeutic Radiological Physics, or Medical Nuclear Physics; (3) American Board of Nuclear Medicine; (4) American Board of Science in Nuclear Medicine; ; (5) Board of Pharmaceutical Specialties in Nuclear Pharmacy or Science; i (6) American Boa.d of Medical Physics in Radiation Oncology Physics; ; (7). He Royal College of Physicians and Surgeons of Canada in Nuclear Medicine; or j (b) Have had 200 hours of classroom and laboratory training as follows: (1) Radiation physics and lastrumentation: . (2) Radiation protection; (3) Mathematics pertaining to the use and measurement of radioactivity; (4) Radiation biology; (5) Radiophannaceutical chemistry; and (6) 1 year of full time experience in radiation safety at a medical institution under the supervision of the individualidentified as the Radiation Safety Officer on an Agency, Agreement State, Licensing State, or U.S. Nuclear Regulatory Commission license that authorizes the medical use of radioactive material; and (c) Be an authorized user fe those radioactive material uses that come within the Radiation Safety Officer's responsibilities. Sec. G.64 Trainine for Friatine P=di 4n Safety Officers. An individual identified as a Radiation Safety Officer on an Agency, Agreement State, Licensing State, or U.S. Nuclear Regulatory Commission license on October 9,1995 who oversees only the use of radioactive matenal for which the licensee was authorized on l' that date need not comply with the training requirements of G.63. ' Sec. G.65 Trainine for Une tre. Dilution. or Excretion m'=dia . Except as provided in G.73 and G.74, the licensee shall require the authorized user of a radiopharmaceutical listed in G.29 to be a physician who: (a) Is certified in: 1 (1) Nuclear medicine by the Am'e rican Board of Nuclear Medicine; (2) Diagnostic radiology by the American Board of Radiology; : l (3) Diagnostic radiology or radiology within the previous five years by the American Osteopathic ' Board of Radiology; or Supp.1 G28 i J r _ _ _ _ _ _ _ _ _ _ _ _ _ __ ___________._____________.__.___._I
- l Sec. G.72 Trainina fo_f Teletheraov Physicist. Thn lictnm s chall
, require the teletherapy physicist to: (a) Be certified by the American Board of Radiology in: (1) Therapeutic radiological physics, (2) Roentgen-ray and gamma-ray phy3ics; (3) X-ray and radium physics; or (4) Radiological physics; or (b) Hold a master's or doctor's degree in physics, biophysics, radiological physics, or health physics, and have completed 1 year of full time training in therapeutic radiological physics and also 1 year of full time work experience under the supervision of a teletherapy physicist at a medical institution. To meet this requirement, the individual shall have performed the tasks listed in G.19, G.56, G.57, and G. 58 under the supervision of a tele-therapy physicist during the year of work experience. Sec. G.73 Trainine for Existino Authorized Users. Practitioners of the healing arts identified as authorized users for the human use of radioactive material on an Agency, NRC or Agreement State or Licensing State license on October 9, 1995 who perform only those methods of use for which they were authorized on that date need not comply with the training requirements of G.63 through G.75. Sec. G.74 Physician Traininc in a Three-Month Program. physician who, before July 1 A 1984, began a 3-month nuclear medicine training program approv,ed by the Accreditation Council for Graduate Medical Education and has successfully completed the program, is exempted from the requirements of G.65 or G.66. 4 Sec. G.75 Recentness of Training. The training and experience specified in G.63 through G.72 shall have been obtained within the 5 years preceding the date of application or the individual shall have had continuing applicable experience since the required i training and experience was completed. Sec. G.76 Ouality Manacement Procram (a) Each applicant or licensee under this part, as applicable, shall establish and maintain a written quality management program to provide high confidence that byproduct material or radiation from byproduct material will be administered as directed by the authorized user. The quality management program must have written ,
)
G35 Supp.1 I I I 1
\
i-! ' policies ~and proc:duraa to mest tha following specific objectives: ' i (1). That, prior to administration, a written directive is 2 prepared for: ! (i) Any teletherapy radiation dose; f i i (ii) Any gamma stereot'ctic a radiosurgery radiation dose; *
-(iii)
Any brachytherapy radiation dose; i' (iv) ! i microcuries of either sodium iodide I-125 or I-131;Any or administration ! (v) Any ' therapeutic administration' radiopharmaceutical, other than sodium iodide I-125 or I-131; a of
.(2) That, prior to each administration, the patient's ;
identity is verified named in the written directive; by more than one method 'as the individual l (3) That i final plans of treatment and related calculations ; i are in accordance with the respective written directives;for b i (4) ! written directive; That each andadministration is in' accordance with the : (5) ' is identified and evaluated, and appropriate action is takenThat an; . i
-(b) The licensee shall: . :
(1) no greaterDevelop procedures for and conduct a review, at intervals i
.than 12 months, of the ;
including, since the last review, an evaluation of: quality management program
'If , because of the patient's condition, 1 health, an oral revision to an existing written directive will be ac provided that the oral revision is Mmted inmediately in the patient's record ,
and of the a revised written directive is signed by the authorized user within 48 hours oral revision. ij Also, a written revision to an existing written directive may be made for any signed diagnostic by anor authorised therapeutic procedureuser prior provided that 'the revision is dated and ' to the radiopharmaceutical dosage, the brach W nistration of- the radiosurgery dose, the teletherapy dose,ytherapy dose, .the gasma stereotactic or the next teletherapy fractional dose. If, because of the emergent nature of the patient's condition, a delay in order to provide a written directive would jeopardize the patient's health, an oral directive will be acceptable, provided that the information contained in the oral directive is documented immediately in the patient's record and a written directive is prepared within 24 hours of the oral directive. Supp.1 G36 - , , - , , , . - ,, n.. ,,.n- w, - . - , , - - . - - - - -
, (i) A repres nta*ive camplo of patient administrations, ' (ii) All recordable events, and (iii) All misadministrations. (2) Evaluate each of these reviews to determine tht . effectiveness of the quality management program and, if required, make modifications to meet the objectives of paragraph (a) of this section; and (3) Retain records of each review, including the evaluations and findings of the review, in an auditable form for three years. (c) The licensee shall evaluate and respond, within 30 days after discovery of the recordable event by: (1) Assembling the relevant facts including the cause; (2) Identifying what, if any, corrective action is required to prevent reoccurrence; and (3) Retain a record, in an auditable form, for three years, of the relevant facts and what corrective action, if any, was taken. (d) The licensee shall retain: (1) Each written directive; and (2) A record of each administered radiation dose or radiopharmaceutical dosage where a written directive is required in paragraph (a) (1) above, in an auditable form, for three years af ter the date of administration. (e) The licensee may make modifications to the quality management program to increase the program's efficiency provided the program's effectiveness is not decreased. The licensee shall furnish any i modification to the Agency for approval prior to the modification : having been made. j (f) (1) Each applicant for a new license, as applicable, shall submit to the Agency a written certification that the quality management program has been implemented along with a copy of the program. ' (2) Each existing licensee, as applicable, shall submit to the Agency a written certification that the quality management program has been implemented along with a copy of the program. G37 Supp.1 I I
4 Part X , r i Use of Radioactive Materials in irradiators l General Provisions I Sec. X.1 Puroose and Scone. (a) This part establishes requirements and provisions for the use of sealed sources containing radioactive materials in irradiators used to irradiate objects or materials using gamma radiation. This part also contains radiation safety requirements for operating irradiators. The requirements of this part are in addition to other requirements in these regulations. Nothing in this part relieves the licensee from complying with other applicable Federal, State and local regulations governing the siting, zoning, land use, and building code requirements for industrial facilities. (b) The regulations in this part apply to panoramic irradiators that have either dry or - . storage of the radioactive sealed sources and to underwater irradiators i.n which both the source and the pro-
]
duct being irradiated are under water. Irradiators whose dose rates exceed 5 grays (500 rads) per hour l at 1 meter from the radioactive sealed sources in air or in water, as applicable for the irradiator type, i are covered by this part. I (c) The regulations in this part do not apply to self-contained dry-source-storage irradiators (those
]
in which both the source and the area subject to irradiation are contained within a device and are not accessible by personnel), medical radiology or teletherapy, radiography (the irradiation of materials for i nondestructive testing purposes), gauging, or open-field (agricultural) irradiations. l Sec. X.2 _ Definitions.
" Doubly encapsulated sealed source" means a sealed source in which l the radioactive material is sealed within a capsule and that capsule is sealed within another capsule.
"Irradiator" means a facility that uses radioactive sealed sources for the irradiation of objects or materials and in which radiation dose rates exceeding 5 grays (500 rads' per hour exist at 1 meter from the sealed radioactive sources in air or water, as applicable for the irradiator type, but does not include irradiators in which both the sealed source and the area subject to irradiation are contained within a device and are not accessible to personnel.
"Irradiator operator" means an individual who has successfully completed the training and testing described in Section X.51 and is authorized by the terms of the license to operate the irradiator without a supervisor present.
" Panoramic dry-source-storage irradiator" means an irradiator in which the irradiations occur in air in areas potentially accessible to personnel and in which the sources are stored in shields made of solid materials. The term includes beam-type dry-source-storage irradiators in which only a narrow beam of radiation is produced for perivrming irradiations.
4
" Panoramic irradiator" means an irradiator in which the irradiations are done in air in areas potentially accessible to personnel. The term includes beam-type irradiators.
" Panoramic wet-source-storage irradiator" means an irradiator in which the irradiations occur in air in areas potentially accessible to personnel and in which the sources are stored under water in a storage X1 Supp.1
- .. _ _ . _ _.-- . _ _ . _ _ . _ _ . _ . _ _._ - _ _ _ . . _ . . . ~ . _ . _ _ _ _ ,
a ( r pool. ! i "Poolirradiator" means any irradiator at which the sources are stored or used in a pool of water ; including panoramic wet-source-storage irradiators and underwater irradiators.
" Product conveyor system" means a system for moving the product to be irradiated to, from, and within the area where irradiation takes place. '
" Radiation room" means a shielded room in which irradiations take place. Underwater irradiators do j not have radiation rooms.
" Seismic area" means any area where the probability of a horizontal acceleration in rock of more than '
O.3 times the acceleration of gravity in 250 years is greater than 10 percent, as designated by the U.S. Geological Survey. ,
" Underwater irradiator" means an irradiator in which the sources always remain shielded under water i and humans do not have access to the sealed sources or the space subject to irradiation without entering the pool. {*
Design and Performance Requirements for Irradiators I l i See X.21 Performance Criteria for S4d Sources. . (a) Sealed sources installed after (the effective date of these regulations 1: l i (1) Must have a certificate of registration issued under 10 CFR 32.210; r (2) Must be doubly encapsulated; . l (3) . Must use radioactive material that is as nondispersible as practical and that is as insoluble as practical if the source is used in a wet-source-storage or wet-source-change irradiator; i
, (4) Must be encapsulated in a material resistant to general corrosion and to localized corrosion, such as 316L stainless steel or other material with equivalent resistance if the i sources are for use in irradiator pools; and (5). In prototype testing of the sealed source, must have been leak tested and found leak-free after each of the tests described in paragraphs (b) through (g) of this section.
t (b) Temoerature. The test source must be held at -40'C for 20 minutes, 600*C for 1 hour, and t i then be subjected to a thermal shock test with a temperature drop from 600*C to 20*C within 15 - seconds. , (c) Pressure. The test source must be twice subjected for at least 5 minutes to an external pres- ' sure (absolute) of 2 million newtons per square meter. (dl Ltngagi.~ A 2-kilogram steel weight, 2.5 centimeters in diameter, must be dropped from a height of 1 meter onto the test source. f i (e)- ~ Vibration. The test source must be subjected 3 times for 10 minutes each to vibrations i E Supp.1 ' x2 I i 5 e O P
- . - - - - - n-- , . - , - --, _ .- - _ . _ - . _ _ . _ _ _ _ _ _ _ . _ - - _ _ _ _ - -
. . - . ~ . . . - - . . - . - - - - . - - . - - - . . - - . - - - - . . - . . . . -
jT , sweeping from 25 hertz ts 500 hertz with a pork amplitude of 5 timis the acceleration of gravity. In I j , addition, each test source must be vibrated for 30 minutes at each resonant frequency found. 1 (f) . Puncture. A 50-gram weight and pin,0.3-centimeter pin diameter, must be dropped from a 1 height of 1 meter onto the test source. l (g) BRDd. If the length of the sourco is more than 15 times larger than the minimum cross- , sectional dimension, the test source must be subjected to a force of 2000 newtons at its center equi- ! distant from two support cylinders, the distance between which is 10 times the minimum cross-sectional dimension of the source. Sec. X.23 Access Control. (a) Each entrance to a radiation room at a panoramic irradiator must have a door or other physical i barrier to prevent inadvertent entry of personnelif the sources are not in the fully shielded position. Product conveyor systems may serve as barriers as long as they prevent inadvertent entry of personnel if the sources are not in the fully shielded position. It must not be possible to move the sources out
. of their shielded position if the door or barrier is open. Opening the door or barrier while the sources i
are not in the ful'y shielded position must cause the sources to return promptly to their fully shielded ' position. The personnel entrance door or barrier must have a lock that is operated by the same key used to move the sources. The doors and barriers must not prevent any individual in the radiation room from leaving. (b) in addition, each entrance to a radiation room at a panoramic irradiator must have an
. independent backup access control to detect personnel entry while the sources are exposed. Detection of entry while the sources are exposed must cause the sources to return to their fully shielded position and must also activate a visible and audible alarm to make the individual entering the room aware of ,
the hazard. The alarm must also alert at least one other individual who is onsite of the entry. That l individual shall be trained on how to respond to the alarm and prepared to promptly render or summon ' assistance. (c) A radiation monitor must be provided to detect the presence of high radiation levels in the radiation room of a panoramic irradiator before personnel entry. The monitor must be integrated with personnel access door locks to prevent room access when high radiation levels exist. Attempted personnel entry while the monitor measures high radiation levels, must activate the alarm described in paragraph (b) of this section. The monitor may be located in the entrance (normally referred to as l the maze) but not in the direct radiation beam. The monitor must also activate a conspicuously visible waming light for personnel entry points. l (d) Before the sources move from their fully shielded position in a panoramic irradiator, the source ; control must automatically activate conspicuous visible and audible alarms to alert people in the radiation room that the sources will be moved from their shielded position. The alarms must give l individuals enough time to leave the room before the sources leave the fully shielded position. ! (e) Each radiation room at a panoramic irradiator must have a clearly visible and readily accessible control that would allow an individual in the room to make the ' sources return to their fully shielded , positior.. (f) Each radiation room of a panoramic irradiator must contain a control that prevents the sources from moving from the fully shielded position unless the control has been activated and the door or barrier to the radiation room has been closed within a preset time after activation of the control. X3 Supp.1
(g) Each entrance to the radiation room of a panoramic irradiator and each entrance to the area within tha personnel access barrier of an underwater irradiator must have a sign beenne the radianon - symbol and the words, " Caution (or danger) radioactive matenal." Panoramic irradiators must also ! i have a sign stating " Grave Danger, Very High Radiaten Ares," but the sign may be removed, covered, or otherwise made inoperative when the sources are fully shielded. (h) If the radiation room of a panoramic irradiator has roof plugs or other nmvable shielding, it must not be possible to operate the irradiator unless the shielding is in its proper location. This requwement may be met by interlocks that prevent operation if shielding is not placed properly or by an operating procedure requiring inspection of shielding before operating. (i) Underwater irradiators must have a personnel access barrier around the pool which must be locked to prevent access when the irradiator is not attended. Only operators and facility management may have access to keys to the personnel access bamer. There must be an intrusion alarm to detect unauthorized entry when the personnel access barrier is locked. Activation of the intrusion alarm must alert an individual (not necessarily onsite) who is prepared to respond or summon assistance. : Sec. X.25 Shieltrjg. . i la) The radiation dose rate in areas that are normally occupied during operation of a panoramic - irradiator may not exceed 0.02 millisieverts (2 millirems) per hour at any location 30 centimeters or . more from the wall of the room when the sources are exposed. The dose rate must be averaged over an area not to exceed 100 square centimeters having no rmear dimension greater than 20 cm. Areas ! j that are not normally occupied where the radiation dose rate exceeds 0.02 millisieverts (2 milliremst i per hour must be locked, roped off, or posted. (b) The radiation dose at 30 centimeters over the edge of the pool of a pool irradiator may not l exceed 0.02 millisieverts (2 millirems) per hour when the sources are in the fully shielded position. .,l (c) The radiation dose rate at 1 meter from the shield of a dry-source-storage panoramic irradiator ' when the source is shielded may not exceed 0.02 millisieverts (2 millirems) per hour and at 5 centimeters from the shield must not exceed 0.2 millisieverts (20 millirems) per hour. i i i Sec. X.27 Fire Protection. (a) ! The radiation room at a panoramic irradiator must have host and smoke detectors. The i detectors must activate an audible alarm. The alarm must be capable of alerting a person who is i
; prepared to summon assistance promptly. The sources must automatically become fully shielded if a fire is detected. {
(b) The radiation room at a panoramic irradiator must be equipped with a fire extinguishing system capable of extinguishing a fire without the entry of personnel into the room. The system for the - radiation room must have a shut-off valve to control flooding into unrestricted areas. ' See X.29 RadiatiogLNIonitors. . (a) Irradiators with automatic product conveyor' systems must have a radiation monitor with an audible alarm located to detect loose radioactive sources that are carried toward the product exit. If the monitor detects a source, an alarm must sound and product conveyors must stop automatically. The alarm must be capable of alerting an individual in the facility who is prepared to summon .
. assistance. Underwater irradiators in which the product moves within an enclosed stationary tube are Supp.1 y f
e
- p
Y ! cxempt from the requir ments of this par:gr ph. ! (b) Underwater irradiators that are not in a shielded radianon room must have a radiation monitor ^ over the pool to detect abnormal radiation levels. The monitor must have an audible alarm and a visible j
- indicator at entrances to the personnel access barrier around the pool. The audible alarm may have j
- i. a manual shut-off. The alarm must be capable of alerting an individual who is prepared to respond i promptly.
{ s { ! Sec. X.31 Control of Source Movement. l i I (a) The mechanism that moves the sources of a panoramic irradiator must require a key to actuate. I Actuation of the mechanism must cause an audible signal to indicate that the sources are leaving the ' j fully shielded position. Only one key may be in use at any time, and only operators or facility ' j management may possess it. The key must be attached to a portable radiation survey meter by a ! i chain or cable. The lock for source control must be designed so that the key may not be removed if l l the sources are not in the fully shielded position. The door to the radiation room must require the same ! ! key. i ! (b) The console of a panoramic irradiator must have a source position indicator that indicates when f i the sources are in the fully shielded position, when they are in transit, and when the sources are ! exposed. (
- i j (c) The control console of a panoramic irradiator must have a control that promptly returns the j 4 sources to the fully shielded position. -
L i (d) Each control for a panoramic irradiator must be clearly marked as to its function. ; i Sec. X.33 Irradiator Pools, f ! (a) For licenses initially issued after (the effective date of these regulational,irradiator pools must: ! I i (1) have a water-tight stainless steel liner or a liner metallurgically compatible with other ; i components in the pool. This liner must be constructed such that a system is provided for the l 3 detection of leaks through the use of a pressurized gas channel located at each weld in the , liner surface.
]
4 (2) the licensee shall have a method to safely store the sources during repairs of the pool, j l (b) For licenses initially issued after (the effective date ofthese regulations), irradiator pools must I have no outlets more than 0.5 meter below the normailow water level that could allow water to drain out of the pool. Pipes that have intakes more than 0.5 meter below the normal low water level and that could act as siphons must have siphon breakers to prevent the siphoning of pool water. (c) A means must be provided to replenish water losses from the pool. (d) A visible indicator must be provided in a clearly visible location to indicate if the pool water
- level is below the normal low water level or above the normal high water level.
(e) Irradiator pools must be equipped with a purification system designed to be capable of maintaining the water during normal operation at a conductivity of 10 microsiemens per centimeter or XS Supp.1 1 I 1
, , . , __l
i :
)
less and with a clarity ss that the sources can be seen clearly. ! (f) A physical barrier, such as a railing or cover, must be used around or over irradiator pools ! during normal ope.1 tion to prevent personnel from accidentally falling into the pool. The barrier may i be removed during maintenance, inspection, and service opersoons. i (g) If long-handled tools or poles are used in irradiator pools, the radiation dose rate on the handling areas of the tools may not exceed 0.00002 sievert (2 milliremst per hour. ; i Sec. X.35 Source Rack PiusctlOn. If the product to be irradiated moves on a product conveyor
. system, the source rack and the mechanism that moves the rack must be protected by a barrier or guides to prevent products and product carriers from hitting or touching the rack or mechanism.
Sec. X.37 Power Failures. l (a) If electrical power at a panoramic irradiator is lost for longer than 10 seconds, the sources must automatically return to the fully shielded position. {i
- - (b) The lock en the door of the radiation room of a panoramic irradiator may not be deactivated by a power failura. j l
r
~
(c) During a power failure, the area of any irradiator where sources are located may be entered ! only when using an operable and calibrated radiation survey meter. I P I Sec. X.39 Desian Reauirements. Irradiators whose construction begins after (the effective date of these regulations), must meet the design requirements of this section. Construction shall not begin until the Agency has reviewed and approved plans submitted by the Applicant, / j! j (a) Shieldina. For panoramic irradiators, the licensee shall design shielding walls to meet generally l accepted building code requirements for reinforced concrete and design the walls, wall penetrations, i and entranceways to meet the radiation shielding requirements of Section X.25. If the irradiator will l use more than 2 x 10" becquerels (5 million curies) of activity, the licenses shall evaluate the effects ! of heating of the shielding walls by the irradiator sources. i (b) Foundations. For panoramic irradiators, the licensee shall design the foundation, with j consideration given to soil characteristics, to ensure it is adequate to support the weight of the facility ' shield walls. (c) Pool Intearitv. For pool irradiators, the licensee shall design the pool to assure that it meets the requirements of X.33(a)(1), that it is strong enough to bear the weight of the pool water and
- shipping casks, that a dropped cask would not fall on sealed sources, that all outlets or pipes meet the -
requirements of Section X.33(b), and that metal components are metallurgically compatible with other
. components in the pool.
(d) Water Handlina System. For poolirradiators, the licensee shall verify that the design of the water purification system is adequate to meet the requirements of Section X.33(el. The system must be designed so that water leaking from the system does~not drain to unrestricted areas without being monitored. (e) Radiation Monitors. For all irradiators, the licensee shall evaluate the location and sensitivity Supp.1 X6
.-. . -. -_ - , - - - - - . = . - - - - - -
. of the monitor t) d;tect sources carried by tha product conveyor syst:m as required by Section
~
X.29(a). The lic:nsee shall verify thIt the product conveyor is designed to stop before a source on the product conveyor would cause a radiation overexposure to any person. For poolirradiators, if the licensee uses radiation monitors to detect contamination under Section X.59(b), the licensee shall verify that the design of radiation monitoring systems to detect pool contamination includes sensitive detectors located close to where contamination is likely to concentrate. i (f) Source Rack. For pool irradiators, the licensee shall vtrify that there are no crevices on the source or between the source and source holder that would promote corrosion on a critical area of the
, source. For panoramic irradiators, the licensee shall determine that source rack drops due to loss of power will not damage the source rack anci that source rack drops due to failure of cables (or alternate means of support) will not cause loss of integrity of sealed sources. For panoramic irradiators, the licensee shall review the design of the mechanism that moves the sources to assure that the likelihood of a stuck source is low and that, if the rack sticks, a means exists to free it with minimal risk to
- persennel.
4 l (g) Access Control. For panoramic irradiators, the licensee shall verify from the design and logic
- diagram that the access control system will meet the requirements of Section X.23.
4 (h) Fire Protection. For panoramic irradiators, the licensee shall verify that the number, location, and spacing of the smoke and heat detectors are appropriate to detect fires and that the detectors are protected from mechanical and radiation damage. The licensee shall verify that the design of the fire extinguishing system provides the necessary discharge pattems, densities, and flow characteristics for complete coverage of the radiation room and that the system is protected from mechanical and ] d radiation damage.
- 1 J
Source Return. For panoramic irradiators, the licensee shall verify that the source rack will (i) automatically return to the fully shielded position if offsite power is lost for more than 10 seconds. (j) Seismic. For panoramic irradiators to be built in seismic areas, the licensee shall design the reinforced concrete radiation shields to retain their integrity in the event of an earthquake by designing ~, to the seismic requirements of an appropriate source such as American Concrete Institute Standard ACI 318-89, " Building Code Requirements for Reinforced Concrete," Chapter 21, "Special Provisions for Seismic Design," or local building codes, if i _ - ent. ) (k) Wirino. For panoramic irradiators, the licensee shall verify that electrical wiring and electrical equipment in the radiation room are selected to minimize failures due to prolonged exposure to radiation. Sec. X.41 Construction Monitorino and Acceotance Testina. The requirements of this section must be met for irradiators whose construction begins after (the effective date of these regulations). The requirements must be met prior to loading sources. (a) Shieldina. For panoramic irradiators, the licensee shall monitor the construction of the shielding !
- to verify that its construction meets design specifications and generally accepted building code requirements for reinforced concrete.
i (b) Foundations. For panoramic irradiators, the licensee shall monitor the construction of the foundations to verify that their construction meets design specifications.
! X7 Supp.1 4
4
4 (c) Pool Intearitv. For pool irradiators, the licenses shall verify that the pool meets design , specifications and meets the requirements of X.33(a)(1). The licensee shall venfy that outlets and pipes meet the requirements of Section X.33(bl. ! (d) W31er Handlina Svstem. For poolirradiators, the licensee shall venfy that the water purification system, the conductivity meter, and the water level indicators operate properly. (e) Radiation Monitors. For all irradiators, the licensee shall verify the proper operation of the ! monitor to detect sources carried on the product conveyor system and the related alarms and interlocks required by Section X.29(aL For pool irradiators, the licensee shall verify the proper operation of the ! radiation monitors and the related alarm if used to meet Secnon X.59(bl. For underwater irradiators, i the licensee shall verify the proper operation of the over-the-pool monitor, alarms, and interlocks ' required by Section X.29(b). (f) Source Rack. For panoramic irradiators, the licensee shall test the movement of the source racks for proper operation prior to source Icading; testing must include source rack lowering due to simulated loss of power. For all irradiators with product conveyor systems, the licensee shall observe and test the operation of the conveyor system to assure that the requirements in Section X.35 are met for protection of the source rack and the mechanism that moves the rack; testing must include tests of any limit switches and interlocks used to protect the source rack and mechanism that moves the rack from moving product carriers. (g) Access Control. For panoramic irradiators, the licensee shall test the completed access control system to assure that it functions as designed and that all alarms, controls, and interlocks work
- properly.
(h) Fire Protection. For panoramic irradiators, the licensee shall test the ability of the heat and smoke detectors to detect a fire, to activate alarms, and to cause the source rack to automatically become fully shielded. The licensee shall test the operability of the fire extinguishing system. (i) Source Retsn. For panoramic irradiators, the licensee shall demonstrate that the source racks can be returned to their fully shielded positions without offsite power. l (j) i Comouter Svstems. For panoramic irradiators that use a computer system to control the j access control system, the licensee shall verify that the access control system will operate properly { if offsite power is lost and shall verify that the computer has security features that prevent an irradiator 1 operator from commanding the computer to override the access control system when it is required to be operable. (k) Wiring. For panoramic irradiators, the licensee shall verify that the electrical wiring and electrical equipment that were installed meet the design specif*mations. Operation of Irradiators Sec. X.51 Trainina. , (a) Before an individual is permitted to operate an irradiator without a supervisor present, the individual must be instructed in: s l (1) The fundamentals of radiation protection applied to irradiators (including the dHc+nen j between external radiation and radioactive contamination, units of radiation dose, d a nmus why large radiation doses must be avoided, how shielding and access controls pre M !ac, Supp.1 xs
- -- . . - . . ~ . . _ _ - - - - - --.------_. - - - -
! dos".s, how cn irradiator is designed t2 pr: vent contamination, thi proper use cf surv1y m*.ttrs i; and personnel dosimeters, other radiation safety features of an irradiator, and the basic < . function of the irradiator); l (2) The requirements of Parts J and X of these regulations that are relevant to the . Irradiator;
- (3) The operation of the irrad'istor; (4) _ Those operating and emergency procedures listed in Section X.53 that the individual j is responsible for performing; and 3 (5) Case histories of accidents or prcGems involving irradiators.
i l (b) Before an individual is permitted to operate an irradiator without a supervisor present, the
- individual shall pass a written test on the mstruction received consisting primarily of questions based on the licensee's operating and emergency procedures that the individual is responsible for performing i and other operations necessary to safely operate the irradiator without supervision.
i (c) Before an individual is permitted to operate an irradiator without a supervisor present, the j individual must have received on-the-job training or simulator training in the use of the irradiator as j described in the license application.~ The individual shall also demonstrate the ability to perform those portions of the operating and emergency procedures that he or she is to perform, i , ! (d) The licensee shall conduct safety reviews for irradiator operators at least annually. The , licensee shall give each operator a written test on the information. Each safety review must include, I to the extent appropriate, each of the following: ' i (1) Changes in operating and emergency procedures since the last review, if any; 4 (2) Changes in regulations and license conditions since the last review, if any;
- (3) Reports on recent accidents, misths, or problems that have occurred at irradiators, j . if any; d
(4) Relevant results of inspections of operator safety performance; ! i i I, (5) Relevant results of the facility's inspection and maintenance checks; and ) (6) A drill to practice an emergency or abnormal event procedure. 1 (e) The licensee shall evaluate the safety performance of each irradiator operator at least annually i to ensure that regulations, license conditions, and operating and emergency procedures are followed. The licensee shall discuss the results of the evaluation with the operator and shallinstruct the operator on how to correct any mistakes or deficiencies observed. (f) Individuals who will be permitted unescorted access to the radiation room of the irradiator or the area around the pool of an underwater irradiator, but who have not received the training required ) for operators ad the radiation safety officer, shall be instructed and tested in any precautions they ; should take to avoid radiation exposure, any procedures or parts of procedures listed in Section X.53 l that they are expected to perform or comply with, and their proper response to alarms required in this s X9 Supp.1
- . . - - _ .- . - - . - - . - . .-. .-._ - .-- .-- ~ . . . . - . , , - .
..~.,._..-..
+
i Pert. Tcsts may be oral. f (g) t Individuals who must be prepared to respond to alarms required by Sections X.23(b), X.23(i), l X.27(a), X.29(a), X.29(b), and X.59(b) shall be trained and tested on how to respond. Each individual t shall be retested at least once a year. Tests may be oral. j Sec. X.53 Ooeratina and Emeroency Pracadores. ' (a) The licensee shall have and follow written operating procedures for: 1 (1) Operation of the irradiator, including entering and leaving the radiation room; i (2) Use of personnel dosimeters: jt (3) . Surveying the shielding of panoramic irradiators; I (4) Monitoring pool water for contamination while the water is in the pool and before release of pool water to unrestricted areas, l (5) Leak testing of sources; ; (6) Inspection and maintenance checks required by Section X.61; . (7) Loading, unloading, and repositioning sources, if the operations will be performed by ! the licensee; and
-l (8) Inspection of movable shielding required by Sectiori X.23(h), if applicable.
(b) The licensee shall have and follow emergency or abnormal event procedures, appropriate for the ,rradiator a type, for: (1) Sources stuck in the unshielded position; j (2) Personnel overexposures: ! (3) A radiation alarm from the product exit portal monitor or pool monitor; I (4)' Detection of leaking sources, pool contamination, or alarm caused by contamination of pool water; l (5) A low or high water level indicator, an abnormal water loss, or leakage from the source storage pool; (6) A prolonged loss of electrical power: (7) A fire alarm or explosion in the radiation room: (8) ~ An alarm indicating unauthorized entry into the radiation room, area around pool, or another alarmed area; (9) Natural phenomena, including an earthquake, a tornado, flooding, or other phenomena Supp.1 ' xio g O
. , = . .
_ as appropriata far the geographical locati:n of the facility; and (10) The jamming of automatic " conveyor systems. Sec. X.55 Personnel Monitorina. (a) Irradiator operators shall wear either a film badge or a thermoluminescent dosimeter (TLD) while operating a panoramic irradiator or while in the area around the pool of an underwater irradiator. The film badge or TLD processor must be accredited by the National Voluntary Laboratory Accreditation Program for high energy photons in the normal and accident dose ranges. Each film badge or TLD must be assigned to and worn by only one individual. Film badges must be processed at least monthly, and TLDs must be processed at least quarterly. (b) Other individuals who enter the radiation room of a panoramic irradiator shall wear a dosimeter, which may be a pocket dosimeter. For groups of visitors, all persons who enter the radiation room are required to wear dosimeters. If pocket dosimeters are used to meet the requirements of this paragraph, a check of their response to radiation must be done at least annually. Acceptable dosimeters .ast read within plus or minus 30 percent of the true radiation dose. Sec. X.57 Radiation Survevs. (a) A radiation survey of the area outside the shielding of the radiation room o' a panoramic irradiator must be conducted with the sources in the exposed position before the facility starts to operate. A radiation survey of the area above the pool of poolirradiators must be conducted after the sources are loaded but before the facility starts to operate. Additional radiation surveys of the shielding must be performed at intervals not to exceed 3 years and before resuming operation after addition of new cr.,orces or any modification to the radiation room shielding or structure that might increase dose rates. 1 (b) If the radiation levels specified in Section X.25 are exceeded, the facility must be modified to comply with the requirements in Section X.25. j (c) Portable radiation survey meters must be calibrated at least annually to an accuracy of 120 percent for the gamma energy of the sources in use. The calibration must be done at two points on each scale or, for digital instruments, at one point per decade over the range that will be used. l Portable radiation survey meters must be of a type that does not saturate and read zero at high i radiation dose rates. ! (d) Water from the irradiator pool, other potentially contaminated liquids, and sediments from pool vacuuming must be monitored for radioactive contamination before release to unrestricted areas. Radioactive concentrations must not exceed those specified in Part D, Table 2 Column 2 or Table 3 of Appendix B, " Annual Limits on intake (Alls) and Derived Air Concentrations (DACs) of Radionuclides for Occupational Exposure: Effluent Concentrations; Concentrations for Release to Sewerage." (e) Before releasing resins for unrestricted use, they must be monitored before release in an area with a background level less than 0.0005 millisievert (0.05 milliremi per hour. The resins may be released only if the survey does not detect radiation levels above background radiation levels. The survey meter used must be capable of detecting radiation levels of 0.0005 millisievert (0.05 millirem) per hour. X11 Supp.1
i 1 ( Sec. X.59 Detection of I eMa Sources. ta) l Each dry source-storage sealed source must be tested for leakage at intervals not to exceed i 6 months using a leak test kit or method approved by the Agency, Agreement State or NRC. In the absence of a certificate from a transferor that a test has been made within the 6 months before transfer, the sealed source may not be used until tested. The test must be capable of detecting the ; i presence of 200 becquerels (0.005 microcuriel of radioactive material and must be performed by a
~ person approved by the Agency, Agreement State or NRC to perform the test. ;
i (b) _For pool irradiators, sources may not be put into the pool unless the licensee tests the sources l for leaks or has a certificate from a transferor that leak test has been done within the 6 months befo; the transfer. Water from the pool must be checked for contamination each day the irradiator operates. L The check may be done either by using a radiation monitor on a pool water circulating system or by analysis of a sample of pool water. If a check for contamirr .n is done by analysis' of a sample of - pool water, the results of the analysis must be available withis. 24 hours. If the licensee uses a radia-tion monitor on a pool water circulating system, the deteccon of above normal radiation levels must activate an alarm. The alarm set-point must be set as low as possible, but high enough to avoid false l l alarms. The licensee may reset the alarm set-point to a higher level if necessary to operate the pool water purification system to clean up contamination in the poolif specifically provided for in written emergency procedures. l (c) If a leaking source is detected the licensee shall arrange to remove the leaking source from service and have it decontaminated, repaired, or disposed of by an Agreement State or NRC licensee that is authorized to perform these functions. The licensee shall promptly check its personnel, equipment, facilities, and irradiated product for radioactive contamination. No product may be shipped until the product has been checked and found free of contamiviation. If a product has been shipped that may have been inadvertently contaminated, the licensee shall arrange to locate and survey that product for contamination. If any personnel are found to be conc,minated, decontamination must be l performed promptly. If contaminated equipment, facilities, or products are found, the licensee shall l arrange to have them decontaminated or disposed of by an Agreement State or NRC licensee that is authorized to perform these functions. If a pool is contaminated, the licensee shall arrange to clean the pool until the contamination levels do not exceed the appropriate concentration in Table 2, Column 2, Appendix B of Part D. Sec. X.61 Insnection and Maintenance. (a) Thelicenseeshallperforminspection and maintenance checksthetinclude, as a minimum,each of the following at the frequency specified in the license or license application: (1) Operability of each aspect of the access control system required by Section X.23;
~
(2) Fonctioning of the source position indicator required by Section X.31(b); . - (3) Operability of the radiation monitor for radioactive contamination in pool water required by Section X.59(b) using a radiation check source, if applicable: (4) Operability of the over-pool radiation monitor at underwater irradiators as required by Section X.29(b): . , (5) Operability of the product exit monitor required by Section X.29(al; i , Supp.1 X12 i-1 i
.n. ~. . , _ - _ , , ,
(6) Operability of the emergency source retum control required by Section X.36.31(c);
~
(7) Leak-tightness of systems t'hrough which pool water circulates (visualinspection); (8) Operability of the heat and smoke detectors and extinguisher system re. quired by Section X.27 (but without turning extinguishers on); (9) Operability of the means of pool water replenishment required by Section X.33(c); (10) Operability of the indicators of high and low pool water levels required by Section X.33(d); ^ l 4 (11) Operability of the intrusion alarm required by Section X.23(i), if applicable; ) (12) Functioning and wear of the system, mechanisms, and cables used to raise and lower sources; a (13) Condition of the barrier to prevent products from hitting the sources or source ! mechanism as required by Section X.35; (14) Amount of water added to the pool to determine if the pool is leaking; (15) Electrical wiring on required safety systems for radiation damage; (16) Pool water conductivity measurements and analysis as required by Section X.63(b); and (17) Leak tightness as required in Section X.33(a)(1). i (b) Malfunctions and defects found during inspection and maintenance checks must be repaired , without ur due delay. l Sec. X.63 Pool Water Purity, f (a) The pool water purification system must be run sufficiently to maintain the conductivity of the pool water below 10 microsiemens per centimeter under normal circumstances. If pool water conductivity rises above 10 microsiemens per centimeter, the licensee shall take prompt actions to lower th's pool water conductivity and shall take corrective actions to prevent future recurrences. (b) The licensee shall measure the pool water conductivity frequently enough, but no less than weekly, to assure that the conductivity remains below 10 microsiemens per centimeter. Conductivity meters must be calibrated at least annually. Section X.65 Attendance Durino Ooeration. (al Both an irradiator operator and at least one other individua~l, who is trained on how to respond and prepared to promptly render or summon assistance if the access control alarm sounds, shall be present onsite: (1) Whenever the irradiator is operated using an automatic product conveyor system; and (2) Whenever the product is moved into or out of the radiation room when the irradiator is operated in a batch mode. X13 Supp.1
, o E
1 i (b) At a p:noramic irradiator at which static irradiations (no movement of the product) are j occurring, a person who has received the training on how to respond to alarms descnbod in Section ~ ,
, X.51(g) must be onsite. ;
(c) ! At an underwater irradiator, an irradiator operator must be present at the facility whenever the i product is moved into or out of the pool. Individuals who move the product into or out of the pool of ! 3 an underwater irradiator need not be qualified as irradiator operators; however, they must have [ received the. training described in Sections X.51(f) and (gl. Static irradiations may be performed i without a person present at the facility. r i See X.67 Enterino and Leavino the Radiation Rossi. / r
- (a) I Upon first entering the radiation room of a panoramic irradiator after an irradiation, the irradiator 1
operator shall use a survey meter to determine that the source has returned to its fully shisided posi- ) l tion. The operator shall check the functioning of the survey meter with a radiation check source prior , to entry. i { (b) l Before exiting from and locking the door to the radiation room of a panoramic irradiator prior j
- . to a planned irradiation, the irradiator operator shalt
- L e ,
(1) Visually inspect the entire radiation room to venfy that it is unoccupied; and ; i , j (2) Activate a control in the radiation room that permits the sources to be moved from the ! j shielded position only if the door to the radiation room is locked within a preset time after setting the control. ,
' , I I
- (c) i j
During a power failute, the area around the pool of an underwater irradiator may not be entered without using an operable and calibrated radiation survey meter unless the over-the-pool monitor j required by Section X.29(b) is operating with backup power. } Sec. X.69 trradiation of Exelosive or Flammable Matsials. i , 5 (a) Irradiation of explosive material is prohibited unless the licensee has received prior written 'f j authorization from the Agency. Authorization will not be granted unless the licensee can demonstrate i ; ' that detonation of the explosive would not rupture the sealed sources, injure personnel, damage safety ! systems, or cause radiation overexposures of personnel. I i j (b) : Irradiation of more than small quantities of flammable material (flash point below 140*F) is
- {
prohibited in panoramic irradiators un'ess the licensee has received prior wntten authorization from the i ! Agency. Authorization will not be granted unless the licensee can demonstrate that a fire in the l radiation room could be controlled without damage to sealed sources or safety systems and without [ radiation overexoosures of personnel. - - { i .i !
- Records i
- 4. :
Sec. X.81 Records and Retention Periods. The licensee shall maintain the following records at the irradiator for the periods specified. " . i (a) h A copy of the license, license conditions, documents incorporated into a license by reference, ! l and amendments thereto until superseded by new documents or until the Agency terminates the j J i 4 j Supp.1 x34 I 1 I 4 . * ;
l i lic nse far d: cum nts n:t superseded.
~ "
(b) Records of each individual's trai ing, tests, and safety reviews provided to meet the requirements of Sections X.51(a), (b), (c), (d), (f), and (g) until 3 years after the individual terminates work. (c) Records of the annual evaluations.of the safety performance of irradiator operators required by Section X.51(e) for 3 years after the evaluation. (d) A copy of the current operating and emergency procedures required by Section X.53 until superseded or the Agency terminates the license. Records of the radiation safety officer's review and approval of changes in procedures as required by Section X.53(c)(3) retained for 3 years from the date of the change. f (e) Film badge and TLD results required by Section X.55 until the Agency terminates the license. l 4
. (f) Records of radiation surveys required by Section X.57 for 3 years from the date of the survey.
(g) Records of radiation survey meter calibrations required by Section X.57 and paol water j conductivity meter calibrations required by Section X.63(b) until 3 years from the date of calibration. ! l (h) Records of the results of leak tests required by Section X.59(a) and the results of contamination checks required by Section X.59(b) for 3 years from the date of each test. ; l ? (i) Records of inspection and maintenance checks required by Section X.61 for 3 years. (j) Records of major malfunctions, significant defects, operating difficulties or irregularities, and j major operating problems that involve required radiation safety equipment for 3 years after repairs are completed. (k) Records of the receipt, transfer and disposal, of all !icensed sealed sources as required by Section A.4. (1) Records on the design checks required by Section X.39 and the construction control checks as required by Section X.41 until the license is terminated. The records must be signed and dated. ; The title or qualification of the person signing must be included. (m) Records related to decommissioning of the irradiator as required by Section C.29. Sec. X.83 Reoorts. (a) The licensee shallimmediately report the following events if not reported under other parts of these regulations: (1) Sour.ce stuck in a not fully shielded position; (2) Any fire or explosion in a radiation room; (3) Damage to the source racks; X15 Supp.1
(4) Fciture of the cable or drive mechanism used to move the source racks. (S) Inoperability of the access control system; (6) Detection of a radiation source by the product exit monitor; I (7) Detection of radioactive contamination attributable to licensed radioactive material; j (8) Structural damage to the pool liner or walls; l i (9) Abnormal water loss or leakage i.om the source storage pool; and I i (10) Pool water conductivity exceeding 100 microslemens per centimeter. l, (b) The report must include a telephone report within 24 hours as described in Section D.1202, and ; a written report within 30 days as described in Section D.1203. l ;
. L l
i 1 l l l 1 l l l t 1 , I i 1 l i ' i . t l l Supp.1 x16
o - a DATED: SEPTEMBER 4,1996 SIGNED BY: DENNIS M. SOLLENBERGER FOR PAUL H. LOHAUS Mr. Roland G. Fletcher, Manager Radiological Health Program , Air and Radiation Management Administration , Maryland Department of the Environment 2500 Broening Highway Baltimore, MD 21224
Dear Mr. Fletcher:
We have reviewed the proposed changes to the Maryland rules, in COMAR 26.12.01.01 as submitted by Mr. Douglas McAbee of your staff via electronic mail on May 30,1996. The proposed rules were reviewed by comparison to the equivalent NRC regulations. We acknowledged receipt of the proposed rules in a teleohone conversation between Mr. Dennis Sollenberger and Mr. Ray Manley, of your staff, on June 18,1996. Preliminary results of our review were discussed between Mr. Richard Blanton and Mr. Manley on July 31,1996. As the result of the review we have five comments, as enclosed. Please note that we are providing only substantive comments that deal with Division 1 or 2 compatability requirements. Under our current procedure, a finding that a rule meets the compatibility requirements may only be made based on a review of the final text of the rule. However, we have determined that if the proposed rules were adopted incorporating the comments and without other significant change, they would be compatible. We request that when the proposed rules are adopted and published as final rules, a copy of the "as published" rules be provided to us for review. As requested in our All Agreement States Letter SP-96-027, "Reauest to Hiahliaht Chances to Aareement State Reaulations Submitted to NRC for Comoatibility Review" (March 1,1996), please highlight the final changes and send one i copy in a computer readable format, if possible. If you have any questions regarding the comments or any of the NRC rules used in the review, please contact me, or call Mr. Richard Blanton at (301) 415-2322. Sincerely, Paul H. Lohaus, Deputy Director Office of State Programs
Enclosure:
As stated 2
Mr. Roland G. Fletcher, Manager Radiological Health Program r Air and Radiation Management Administration Maryland Department of the Environment 2500 Broening Highway i Baltimore, MD 21224
Dear Mr. Fletcher:
r We have reviewed the proposed changes to the Maryland rules, in COMAR 26.12.01.01 as submitted by Mr. Douglas McAbee of your staff via electronic mail on May 30,1996. The proposed rules were reviewed by comparison to the equivalent NRC regulations. We acknowledged receipt of the ! proposed rules in a telephone conversation between Mr. Dennis Sollenberger and Mr. Ray Manley, of your staff, on June 18,1996. Preliminary results of our rev;aw were discussed between Mr. Richard Blanton and Mr. Manley on July 31,1996. i As the result of the review we have five comments, as enclosed. Please note that we are providing only substantive comments that deal with Division 1 or 2 compatability requirements. Under our current procedure, a finding that a rule meets the compatibility requirements may j only be made based on a review of the final text of the rule. However, we have determined that ) if the proposed rules were adopted incorporating the comments and without other significant change, they would be compatible. We request that when the proposed rules are adopted and published as final rules, a copy of the "as published" rules be provided to us for review. As requested in our All Agreement States Letter SP 96-027, "Recuest to Hiahlicht Chanaes to Aareement State Reaulations Submitted to NRC for Comoatibility Review" (March 1,1996), please highlight the final changes and send one ; copy in a computer readable format, if possible. If you have any questions regarding the comments or any of the NRC rules used in the review, please contact me, or call Mr. Richard Blanton at (301) 415-2322. Sincerely, Paul H. Lohaus, Deputy Director Office of State Programs
Enclosure:
As stated Distribution: DlR RF (6S-170) DCD (SP05) PDR (YES) RLBangart PLohaus RBlanton Maryland File SDroggitis l DOCUMENT NAME: G:\RLB\MD9605764Msious concurrence ' n r c.tv. . con ce is accum.nt. insic.t. in the e,ox: c cm .mout ememenancue. r con -m amenmenancioire v No con l OFFICE OSP* lC OSP:DD l OGC l OSP;D l l [NAME RLBlanton:gd PLohaus FXCameron RLBangart jDATE 08/02/96 08/ /96 08/ /96 08/ /96 OSP FILE CODE: SP-AG-14 l j
e , I [ . COMMENTS ON PROPOSED MARYLAND REGULATIONS l CHANGE REQUIRED FOR CURRENT COMPATIBILITY Definition Comment ) i Prescribed dosage This definition was designated a division 1 compatibility requirement by the Commission (56 FR 34104), to be adopted by the Agreement States i by January 27,1995. In order to achieve l compatibility, insert " diagnostic clinical procedures" i before " manual" in section (2). l l l CHANGES RECOMMENDED FOR FUTURE COMPATIBILITY ; l The following definitions in the proposed Maryland regulations are equivalent to NRC definitions that have been amended. Under the current NRC policy, the amendments must be adopted by the Agreement States within three years of the effective date for NRC licensees in order to maintain compatibility. Although implementation of the new policy on Adequacy and Compatibility may change the compatibility classifications of some NRC rules and definitions, and the requirements of NRC rules may be adopted in the form of legally binding requirements other than rules, we recommend that you adopt the latest version of the definitions in this rulemaking, if it is practicable for you to do so. Definition Comment Occupational dose Amended effective October 20,1995 (60 FR Public dose 48623), currently expected to be adopted by the Agreement States by October 20,1998. Recordable event Amended effective January 1,1995 (59 FR 61767), currently expected to be adopted by the Agreement States by January 1,1998. The amended paragraphs are: (5) A teletherapy radiation dose when the calculated weekly administered dose exceeds the weekly prescribed dose by 15 percent or more of the weekly prescribed dose; or (6) A brachytherapy radiation dose when the calculated administered dose differs from the prescribed dose by more than 10 percent of the prescribed dose. Written directive Amended effective January 1,1995 (59 FR 61767) currently expected to be adopted by the Agreement States by January 1,1998. The amendment adds ; the term "or human research subject" after the 1 l word " patient." l l
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DATED: AUGUST 21,1996 SIGNED BY: PAUL H. LOHAUS Mr. Roland G. Fletcher, Manager Radiological Health Program Air and Radiation Management Administration Maryland Department of the Environment 2500 Broening Highway Baltimore, MD 21224
Dear Mr. Fletcher:
We have reviewed the responses in your letter dated June 25,1996, to our comments on the proposed Maryland regulations for large irradiators. As the result, we have one concern which was discussed by Mr. Ray Manley, of your staff, and Mr. Richard Blanton, of my staff, on July 31,1996. In regard to our comment that a rule equivalent to 10 CFR 36.15 was not included in the package of regulations submitted for review, the response noted that it is the position of your program that construction of any portion of the permanent irradiator structure may not commence until a license has been issued. You note that this position is more conservative than the NRC rule. We concur that your position is as stringent, or more stringent, and therefore, would be compatible under current compatibility procedures, if it were to be expressed as a rule, provision of law, or other legally binding regulatory requirement. However, since we are unable to find such a basis for your position, we are unable to find the rule compatible under current compatibility procedures. We ask that when the proposed rules are adopted and published as final rules, a copy of the "as published" rules be provided to us for review. As requested in our All Agreement States Letter SP-96-027, "Reauest to Hiahlicht Chanaes to Aareement State Reaulations Submitted to NRC for Comontibility Review" (March 1,1996), please highlight the final changes and send one copy in a computer readable format, if possible. If you have any questions regarding the comments or any of the NRC rules used in the review, please contact me or Mr. Richard Blanton of my staff at (301) 415-2322. Sincerely, Paul H. Lohaus, Deputy Director Office of State Programs
, l 1 Mr. Roland G. Fletcher, Manager Radiological Health Program Air and Radiation Management Administration , Maryland Department of the Environment
- 2500 Broening Highway ;
Baltimore, MD 21224 t
Dear Mr. Fletcher:
We have reviewed the responses in your letter dated June 25,1996, to our comments on the ! proposed Maryland regulations for large irradiators. As the result, we have one concern which l was discussed by Mr. Ray Manley, of your staff, and Mr. Richard Blanton, of my staff, on July J 31,1996. In regard to our comment that a rule equivalent to 10 CFR 36.15 was not included in the packeye . of regulations submitted for review, the response noted that it is the position of your program ! that construction of any portion of the permanent irradiator structure may not commence until ' a license has been issued. You note that this position is more conservative than the NRC rule. We concur that your position is as stringent, or more stringent, and therefore, would be ! compatible under current compatibility procedures, if it were to M expressed as a rule, provision of law, or other legally binding regulatory requirement. rlowever, since we are unable to find such a basis for your position, we are unable to find the rule compatible under current compatibility procedures. j We ask that when the proposed rules are adopted and published as final rules, a copy of the "as published" rules be provided to us for review. As requested in our All Agreement States Letter SP 96-027, "Reauest to Hiabliaht Chanaes to Aareement State Reaulations Submitted to NRC for , Comoatibility Review" (March 1,1996), please highlight the final changes and send one copy in a computer readable format, if possible. l if you have any questions regarding the comments or any of the NRC rules used in the review, please contact me or Mr. Richard Blanton of my staff at (301) 415-2322. Sincerely, Paul H. Lohaus, Deputy Director Office of State Programs i Distribution. I DlR RF (6S-178) DCD (SPOS) PDR (YES) RLBangart PLohaus RBlanton Maryland File FCameron
'See previous concurrence DOCUMENT NAME: G:\RLB\MD6-25.RLB n rec.iv copy or w. socum.nundiem in m. box: c copy weout asemenv noo.u= r copy we summenveneo.um v = we copy I OFFICE OSP lC OSP:DD l OGC l OSP:D l l I i NAME RLBlanton PLohaus FXCameron RLBangart I DATE 08/01/96" 08/02/96* 08/14/96* 08/ /96 OSP FILE CODE: SP-AG-14 I 1
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DATED: MAY 20, 1996 SIGNED BY: PAUL H. LOHAUS Mr. Roland G. Fletcher Acministrator Radiological Health Program Maryland Department of the Environment 2500 Broening Highway Baltimore, Maryland 21224
Dear Mr. Fletcher:
We have reviewed the proposed Maryland rules, Part X, Use of Radioactive Materials in Irradiators, which we received from Mr. Doug McAbee, of your staff, on April 5,1996. The rules were reviewed in comparison to the equivalent NRC regulations in 10 CFR Part 36. We acknowledged receipt of the proposed rules on April 18, 1996, in a telephone message to Mr. McAbee. As the result of the review we have three comments, as enclosed. Under current policy, a finding that a rule meets the compatibility requirements is made only after a review of the final rule. However, we have determined that ; if the proposed rules were adopted with the enclosed recommendations and without other significant change, they would be compatible. We request that when the final rules are adopted and published, a copy of the "as published" ! rules be provided to us for review. As requested in our All Agreement State Letter SP 96 027, " Request to Hichlicht Chanaes to Aareement State Reaulations Submitted to NRC for Comoatibility Review" (March 1,1996) please highlight all changes and send one electronic copy, if possible. If you have any questions regarding the comments or any of the NRC rules used in the review, please contact me or Mr. Richard Blanton, of my staff, at (301) 415 2322. Sincerely, Paul H. Lohaus, Deputy Director Office of State Programs
Enclosure:
r. l l l I Comments on Proposed Maryland Irradiator Regulations 4 l l I
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1 Mr. Roland G. Fletcher, Administrator Radiological Health Program Maryland Department of the Environment 2500 Broening Highway Baltimore, Maryland 21224
Dear Mr. Fletcher:
i We have reviewed the proposed Marylend rules, Part X, Use of Radioactive Materials in Irradiators, which we received from Mr. Doug McAbee, of your staff, on April 5,1996. The rules were reviewed in comparison to the equivalent NRC regulations in 10 CFR Part 36. We acknowledged receipt of the proposed rules on April 18, 1996, by telephone message to Mr. McAbee. As the result of the review we have three comments, as enclosed. Under current policy, a finding that a rule meets the compatibility requirements is made only after a review of the final rule. However, we have determined that if the proposed rules were adopted with the enclosed recommendations and without other significant change, they would be compatible. We request that when the final rules are adopted and published, a copy of the "as published" rules be provided to us for review. As requested in our All Agreement State Letter SP 96 027, "Reauest to Hichlicht Chanaes to Aareement State Reaplations Submitted to NRC for Comoatibility Review" (March 1,1996) please highlight all changes and send one electronic copy, if possible. If you have any questions regarding the comments or any of the NRC rules used in the review, please contact me or Mr. Richard Blanton, of my staff, at (301) 415 2322. Sincerely, Paul H. Lohaus, Deputy Director Office of State Programs
Enclosure:
Comrrents on Proposed Maryland Irradiator Regulations Distribution: DIR RF (6S 90) DCD (SP05) PDR (YES) RLBangart FCameron. 0GC PLohaus RBlanton Maryland File CGordon, RI
*See previous concurrence DOCUMENT NAME: G:\RLB\MD96EQ36.RLB Te recehre e copy of this alocument, indcate in the boa: 'C' = Copy without attachment / enclosure *E' = Copy wnh attachment / enclosure 'N" = No copy OFFICE OSP lC OSP:DD l OGC l OSP:D l NAME RLBlanton:gd PLohaus FXCameron RLBangart DATE 04/26/96* 04/29/96* 05/09/96* 05/ /96 OSP FILE CODE: SP-AG-14
l COMMENTS ON PROPOSED MARYLAND IRRADIATOR REGULATIONS Definition Comment
" Annually" An equivalent definition was not found in the submitted rules. Unless the definition is located elsewhere in the Maryland rules, it must be adopted to maintain ]
compatibility.
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Regulations Comment j [Nonel Equivalent to 10 CFR 36.13 (Division 2). An equivalent rule was not found in the submitted rules. To maintain l compatibility, a rule addressing the requirements of 536.13(b) through (h) must be adopted unless the requirements are imposed by law or elsewhere in the Maryland rules. [None] Equivalent to 10 CFR 36.15 (Division 2). An equivalent rule was not found in the submitted rules. To maintain compatibility, a rule addressing the requirements of the NRC rule must be adopted unless the requirements are imposed l by law or elsewhere in the Maryland rules. )
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AGREEMENT STATE RULE REVIEW Maryland 1996 Proposed Part X - Large Irradiator Rules t April 1996 ! EXPLANATION OF FINDINGS CODES IN THE COLUMN LABELED " ACCEPTABLE" OR " STATE RULE": For Division 1 definitiors:
"[y]" means fne submitted definition is essentially identical to the equivalent CFR definition. "[No]" means the definition was NOT submitted; or the submitted definition is NOT essentially identical to the equivalent CFR defin% ion, as explained in the endnote.
For Division 1 regulations: A State secthn number in the "[]" (without redline) means the submitted regulation is essentially identical to the equivalent CFR regulation. Redline means the submitted regulation is NOT essentially idutical, as explained in the ENDNOTE. An entry of
"[None]" mear;s an equivalent regulation was not submitted.
For Division 2 definitem:
"[y]" means the submitted definition is essentially identical to, or more stringent (protective) than, the equivalent CFR definition. "[No]" means the definition was NOT submitted; or the submitted definition is NOT essentially identical to, or more stringent (protective) than, the equivalent CFR definition, as explained in the endnote.
For Division 2 regulations: A State section number in the "[]" (without redline) means the submitted regulation is essentially identical to, or more stringent (protective) than, the equivalent CFR regulation. Redline means the submitted regulation is NOT essentially identical to, or more stringent (protective) than, the equivalent CFR regulation, as explained in the ENDNOTE. An entry of"[None]" means an equivalent regulation was not submitted. For Division 3 definitions and regulations:
"[y]" or a section number in the "[]" (without redline) means the submitted definition or regulation addresses the same substance as the equivalent CFR definition or regulation, and does not conflict with a definition or rule required for compatibility. "[No]" or a redlined section number means the submitted definition or regulation is NOT ACCEPTABLE, as explained in the ENDNOTE. A
"[-]" means an equivalent definition or regulation was not submitted.
Definitions and regulations are considered " essentially identical" only if they are word for word the same, except for the following
-- ~.. . ... ._ . _- .-. . - .- - - - .
specific differences: A. Identifying numbers may be changed to conform to the State numbering system. B. The provisions of a definition or regulation may be resequenced. C. i. Terms may be substituted for " commission,"" agency,""this part,""this chapter" or "these regulations." ii. The word " rule" may be interchanged with the word " regulation," and the word "shall" may be interchanged with the word "must." ' iii. Other non-substantive wording changes similar in nature may be made to conform the definition or regulation to the State , editorial style. D. The definition or regulation may be expanded to incorporate sources of radiation other than source, byproduct and special nuclear materials, provided the additional sources are subject to the same requirements. E. The definition or regulation may specify the use of SI units for recordkeeping and reporting. F. Any portion of the text of a CFR definition or regulation which provides supplemental information, an example, or a reference (for convenience) to another definition or regulation may be omitted. For division 1, any other difference between the submitted definition or regulation and the equivalent CFR definition or regulation must be discussed in an endnote. For division 2, in addition to the above, any difference that does not decrease the stringency (protectiveness) of submitted definition or regulation compa-d to the equivalent CFR definition or regulation is acceptable. Any other difference must be discussed in an , cndnote. For division 3, an endnote must be generated if the definition or regulation conflicts with a definition or regulation required for compatibility. For all divisions, endnotes should also be used to document reviewers observations and changes made by the State in response to comments on earlier versions of draft rules. NOTE: The SSR equivalent to the CFR rules are for information only. Current procedure is to determine compatibility by comparison ! of State rules directly to the CFR equivalent rules only. t 2
Rule Package: Maryland 1996 Proposed Part X - Large Irradiator rules Div INfR6rtole SSR eauivalent REE8 sub_iect SSH Acceptable State rule 2 Annually 36.2 - [N]' 2 Doubly encapsulated sealed source 36.2 - [y] 2 Irradiator 36.2 - [y] 2 Irradiator operator 36.2 - [y] 2 Panoramic dry-source-storage irradiator 36.2 - [y] 2 Panoramic irradiator 36.2 - [y] 2 Panoramic wet-source-storage irradiator 36.2 - [y] 2 Poolirradiator 36.2 - [y] 2 Product conveyor system 36.2 - [y] 2 Radiation room 36.2 - [y] 2 Seismic area 36.2 - [yL 2 Underwater irradiator 36.2 - [y; 3
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Rule Package: Maryland 1996 Proposed Part X - Large Irradiator rules - Diy NRC rule SSR eauivalent Rule sub_iect State rule 10 CFR Part 36 LICENSES AND RADIATION SAFETY REQUIREMENTS FOR IRRADIATORS
- NOTE ~
Part 36 as a whole was determined to be a Division 2 compatibility requirement by the Commission in 58 FR 7715, however compatibility requirements for specific sections were not determined. The divisions shown herein are TENTATIVE based on application of the B.7 criteria and past practices. 3 36.1 ---- Purpose and scope [X.1] i i 2 36.2 ---- Definitions (See above) [X.2] 3 36.5 A.11 Interpretations [-] 3 36.11 ---- Application for a specific license [-] 2 36.13 ---- Specific licenses for irradiators [None]2 2 36.15 ---- Start of construction [None]' 3 36.17 ---- Application for exemptions [-] 3 36.19 ---- Request for written statements [-] 2 36.21 ---- Performance criteria for sealed sources [X.21] 2 36.23 ---- Access control [X.23] 2 36.25 ---- Shielding [X.25]* 2 36.27 ---- Fire protection [X.27] 2 36.29 ---- Radiation monitors ' [X.29] 2 36.31 ---- Control of source movement [X.31] 4
Rule Package: Maryland 1996 Proposed Part X - Large Irradiator rules Div NRC rule SSR eauivalent Rule sub_iect State rule 2 36.33 --- Irradiator pools [X.33]5 i 2 36.35 ---- Source rack protection [X.35] , 2 36.37 ---- Power failure [X.37] 2 36.39 ---- Design requirements [X.39] 2 36.41 ---- Construction monitoring and acceptance testing [X.41]* 2 36.51 ---- Training [X.51] , 2 36.53 ---- Operating and emergency procedures [X.53]' 2 36.55 ---- Personnel monitoring [X.55]* 2 36.57 ---- Radiation surveys [X.57] 2 36.59 ---- Detection ofleaking sources [X.59] 2 36.61 ---- Inspection and maintenance [X.61] l 2 36.63 ---- Poolwater purity [X.63] 2 36.65 ---- Attendance during operation [X.65] 2 36.67 ---- Entering and leaving the radiation room [X.67] i 2 36.69 ---- Irradiation of explosive or inflammable [X.69] [' materials 3 36.81 ---- Records and retention periods [X.81] 2 36.83 ---- Reports [X.83] 5 _ _ . - . _ _ _ _ . - _ _ . _ _ _ _ _ . _ _ _ _ _ _ . _ _ _ _ _ . _ _ _ _.___.__.__m._.. - - _ _..-__.. . _ _ _ _ _ _ _ _ _ _ . _ _ _ _ . _
t Rule Package: Maryland 1996 Proposed Part X - Large Irradiator rules I Dir NRC rule SSR eauivalent Rule sutnect State rulgt 3 36.91 A.8 Violations [-] 3 36.93 A.8 Crimirial penalties [-] t 4 f i i t t 6 -
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.-_. ~ _ . - _ _ _ . _ _ . . - . - _ . - . - _ . _ _ _ - . _ . . . _ . _ . _ _ _.__.._._.- _ _._._. ._._.. _ _. _- NOTES: i
- 1. Definition " Annually" j
COMMENT: Definition not submitted.
- 2. [None] = 10 CFR 36.13 COMMENT: An equivalent rule was not submitted. A rule addressing the requirements of $36.13(b) through (h) ,
must be adopted unless the requirements are imposed elsewhere. :
- 3. [None] = 10 CFR 36.15 ,
COMMENT: An equivalent rule was not submitted. A rule addressing the requirements must be adopted unless ! the requirements are imposed elsewhere. ; i
- 4. X.25(b) = 10 CFR 36.25(b)
COMMENT: Editorial error - should be "0.00002' l
- 5. X.33(a)(2) = 10 CFR 36.33(a)(2)
REVIEWER'S NOTE: The requirements in X.33(a)(1) are different, but compatible. COMMENT: (Editorial) The provision reads rough, we suggest taking out the words "the licensee shall".
- 6. X.41(c) = 10 CFR 36.41(c) r REVIEWER'S NOTE: The text of the Maryland rule reflects the difference in X.33(a)(1), but is compatible.
- 7. X.53 = 10 CFR 36.53 REVIEWER'S NOTE: Provisions equivalent to subsection (c)are not proposed This will have the effect of requiring advanced approval by the agency of all revisions to operating and emergency procedures. This is more stringent than, and compatible with, the equivalent NRC rule.
- 8. X.55 = 10 CFR 36.55 7 1 i
- - .. . - - . - - - - . . .~.. - - - . . - . . - . - - _ ,
REVIEWER'S NOTE: In subsection (b), the NRC rule only requires two persons in a group to be monitored, the Maryland rule requires each individual in a group to be monitored. This is more stringent and compatible. +
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