ML20141J327
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(M- %L Db March 7.1997 B.W. Ahluwalia, Ph.D., President American College of Nuclear Medicine l P.O. Box 175 '
l Landisville, PA ';7538 l
l
Dear Dr. Ahluwalia:
In October 1991, the American College of Nuclear Medicine (ACNM) submitted a petition for l
rulemaking (and an amended petition in April 1992) requesting that the Commission amend its regulations regarding the release of patients containing radiopharmaceuticals or permanent implants.
As a result of your petition, the Commission has considered and approved final amendments to i
i 10 CFR Parts 20 and 35. These amendments have been published in the federcl Realster (62 FR 4120; January 29,1997) and will become effective on May 29,1997, i
Sincerely, I
Original Signed By Cheryl A. Trottier, Acting Branch Chief Radiation Protection and Health Effects Branch Division of Regulatory Applications Office of Nuclear Regulatory Research l
Enclosure:
Federal Register Notice Distribuuon: (g1schneidthankyou.frm)
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Federal Regleter / Vol. 02, No.19 / Wednesday, J:nuary 29, 1997 / Rules and Regulations g :i We havs dete mined that laulslana NUCLEAR MEGULATORY FOR FURTHER WFhATION CONTACTI meets the siandards for Class Free COMMISSION Stewart Scaneider, Office of Nuclear ,
etatus. The interim rule was necessary Regulatory llewarch, U.S. Nuclear !
to relieve certain restrictions on the 10 CFR Parts 20 and 35 Reputatory Commission. Wuhington, i interstate inovement of cattle from 2055$ telephone (301) 41H225.
"I"I"""' MIN 3160-AE41 4 I,llacksnmnd !
If FECTrVE DATil The interim rule was Critoria for the Molosse of individuals effective on October 31,1990. Administered Radioactive Meterial f4ch year in the United States, radioactive phartnaceutacals or FOR FURTHER INF0nteATION 00NTACTl Dr. AOtNCYi Nuclear Regulatrary compounds or radioactive implants are Michael J. Gilsdorf, Santor Staff Cornmission.
Veterinarian, Brucellosis Etadication admlnistered to approximately 8 to 9 ACTION! Final rule, inillion individuals for the diagnosis or .
Staff, VS, APillS, USDA, Suite 3B08, treatment of disease or for human 4700 River Road Unit 36. Riverdale, MD suuuARY:The Nuclear Regulatory researth. These individuals to whom 20737-1230;(301) 734-7708. Commission (NRC)is amending its
"* radioactive materials have been sWPPLeistNTART INFORt4ATION!
regu all ne concerniDg the criteria for administered are hereinsiter referred to the release of patients administered a " patients." These pathnts can expose llackground radioactive material. The new criteris others around them to radiation until for patient release are based on the the radioactive material has teen in an interim rule effective and potential dose to other individuals excreted from their bodies or the r 31, t o (0 f 50 56 8 exp wd to the patient. The new criteria radioactivity has decayed away.
Docket No. 90-043-1), we amended the are t nais ont with th' NRC's current patient release criteria brucellosis regulations in 9 Cl R art 78 recominondations of the National in to CFR 35.75," Release of patients or Council on Radiation Protection and human research sub vets containing Measurements (NCRP) and the radlopharmaceutica a or permanent C ans A t a n I 78 41( and ad in8 International Comraission on it t e list of Class Free States in implants " are as 'ollows-Radiological Protection (ICRP). This
- - "(a) A licensee may not authoriae final rule requires the licensee to Comments on the inferim rule were release from confinement for medical pmvide written instructions to patients required to be received on or lefore care any bsattent or December 30,1990. We did not receive on how to maintain the doses to others subject a ministered a human research rwented in as low as is reasonably achievable if the radiopharmaceutical until either: (1) eny comments. The facts {de a total basis fcr effective dose equivalent to any -
the interim rule still prov The measured dose rate from the patient the rule. other individual exposed to the released or human research subject is less than patient is likely to exceed 1 millislevert 5 miiltrems por hout at a distance of1 Thir ar tion also affirms the (0.1 tem). This final rule responds to meter; or (2) The activity in the patient information contained in the interim Omie petitions for rulemaking regarding or human research subloct is less than rule concerning Executive Order 12800 the criteria for release of patients t.nd the Regulatory Flexibility Act, administered radioactive meterial, 30 millicuries;(b) A licensee may not authorize release from confinement for Executive Orders 12372 and 12988, and EFFfCTIVE DATE: May 29,1997, medical care of any patient or human the Paperwork Reduction Act.
ADontsstat Copies of Regulatory Guide research subject administered a Further, for this actio.a. the Office of 8.39 " Release of Patients Administered permement implant until the measured Management and Budget has waived the Radioactive Materials"; the final dose rate from the patient or human review process required by Executive regulatory analysis, NUREG-1492, research subject is less than 5 millirems Order 12800. " Regulatory Analysis on Criteris for the per hour at a distance of 1 meter,"
List of Subjects in 9 CFR Part 7e Release of Patients Administered On Me 21,1991 (56 FR 23360), the >
Radioactive Material" (1997); Revision 2 NRC pub ished a final rule that Animal diseases, Dison, Cattle, llogs, of NUREC/DR-0050," Regulatory amended to CFR part 20," Standards for Quarantine Reporting and Analysis Guidelines of the U.S. Nuclear Protection Against Radiation,"The rule recordleeping requirements. Regulatory Commission" (1996); and the contained limits on the radigtlon dose Transportation. public comments received on the for members of the public in 10 CFR proposed rule may le examined sind 20.1301, llowever, when to CFR part 20 PART 78-BRUCELLOSIS copied for a fee in the Commission's was issued, there was no discussion in Accordingly, we are adopting as a Public Document Room at 2120 L Street the supplementary information on :
NW, (Lower Level), Washington, DC. whether or how the provisions of to final rule, without change, the interim Single copies of Regulatory Guide 8.39 CFR 20.1301 were intended to apply to rule that amended 9 CFR 78 and that was published at 01 FR 56116-56110 on snay be obtained free of charge by the release of patients.
October 31,1990. writing the Office of Administration. Some licensees were uncertain about Attn: Distribution and Services Section, what effect the revised 10 CFR part 20 Authority: 21 U.S.C.111-114a.1,114g. USNRC Washington, DC 20555, or by would have on patient release criteria, 115.117,120,121,123-120,134b, and 134f; fax at (301) 415-2200. Single copies of and two petitions for rulemaking were 7 CFR 2.22,2.80, and 3rt.2(d).
NUREG-1492 and NUREG/DR-0058 received on the issue. On June 12,1991 Done in Washington. DC. this 23rd day of may be purchased at current rates from (56 FR 26945), the NRC published in the January 1997, the U.S. Government Printing Office, Federal Register a notice of roccipt of.
Terry to Medley, P.O. Box 37082, Washington, DC 20402- and request for comment on, a petition Administrutor. Anirnaland Plantilcalth 9328 (telephone (202) 512-1800); or for rulemaking (I RM-20-20) from Dr, inspection SerWee, from the National Technical information Carol S. Marcus. In addition Dr. Marcus (FR Doc. 97-2198 Filed 1-ta-97; 8:45 ami Service at 5285 Port Royal Road, submitted a letter dated June 12,1992, asumocooeso us-c Springfield, VA 22161, further characterizing her position.
Fedxt:1 R: gist:r / Vol. 02, No.19 / Wodemsday, January 29, 1997 / Itules nnd Regul:tions 4121 On Mitt h 9,1992 (57 PR n282), the from pztients administered radioactive wleawd peticut and the calculated total NRC published a notice of newlpt and material and reWand in accordarpe effective dose equivalent to the request for comtnent in the s'ederal with 10 CTH 35.75. The purpose was to Register on another petition for individual likely to teceive the highest clarify that licent.oes would not be dose if the total effective dose rulemaking (PRM-35-10) on patient acquired to control areas (such as equivalent to any ludividual other than releau criteria from the American waiting rooms) simply because of the the retcased patient is likely to exccod College of Nuclear Medicine (ACNM). presence of a patient released pursuant On May 10,1992 (57 l'R 21043), the 1 millislevert (0.1 rem)in a year from to 10 CFR 35.75. If a patient has been a single administration, The major NRC published in the rederal Register released from licensee control pursunut purpose was to provide a record to notice of an amendment' submitted by to 10 CFR 35.75, licenwes would not be allow licenwes to assess the need to the ACNM to its original petition (PRM- required to limit the radiation dose from limit the dose to individuals exposed to 35-10A). a patient to members of the public (e.g., a patient who may receive more than in addition, a third petition (PRM visitors in a waiting roorn) to 0.02 one adtninistsstion in a year.
- 11) dealing,in part, with these same millislevert (2 milliremslin any 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br />.
lasues was submitted by the American Finally, the NRC proposed to amend Patient waiting roorns or hospital rooms its requirements on instructions in to Medical Association (AMA).That would need only be controllod for those CFR 35.315(a)(0) and 35.415(a)(B). These petition was noticed in the Federal patients not meeting the release criteria regulations already required Kegister on July 20,1094 (50 FR 37950). In to CFR part 35, l instructions (not necessarily written)in The main point raised in the petition The NRC proposed to adopt a new to cortsin cases, but the phrase "if required i
was that the radiation dose limits in to CTR 35.75(a) to change the patient by $ 35.75(b)" was added to each. The CPR part 20 should not apply to release criteria from 1.110 purpose of this change was to make part individuals exposed to the pa' dent and megabecquerels (30 millicuries) of 35 consistent as to when instructions that the dose Ifmit to the individuals activity in a patient or a dose rate of must be given.
' should be 500 millitems per year. The 0.05 millislevert (5 millirems) per hour in addition, the NRC concurrently AMA believed that to CFR 20.1301 at 1 meter from a patient to a total issued an associated draft regulatory '
would have an adverse impact on the offective dose equivalent not to exceed availability and the cost of treatment of guide and supporting draft retulatory 5 millisleverts (0.5 rem)in any 1 year analysis for public comment. The draft thyroid disease, which would outwelS h to an individual from exposure to a ngulatory guide, IX;-8015. " Release of the advantages of toduced radiation . released patient. A done based limit patients Administered Radioactive exposure to the public. The AMA stated provides a single limit that could be Materials," posed guldance on that treatment of up to 10,000 cancer used to provide an equivalent level of determinin is potential doses to an patients annually for thytold carcinoma riska from all radionuclides. Also, the individual kely to receive the highest would require the hospitalir.ation of the proposed changes were supported by dose from exposure to a patient and patients under the revised regulation (10 the recommendations of the ICRp and established appropriate activitles and CFR 20.1301), reducing both early the NCRP that an individual could be dose rates for release of a patient.The release of patients and the trestment of allowed to roccive an annual done up to draft guido also proposed guidelines on patients at home. 5 millisleverts (0.5 rem)in temporary instructions for patients on how to
!!, Publication of the ProPooed Rule situations when exposure to radiation is maintain doses to other individuals as not expected to result in annual doses low as is reasonably achievable and it On June 15,1994 (59 FR 30724),in above 1 millislevert (0.1 rem) for long described recordkeeping requirements, response to the first two petitions, the pedods of time. The draft regulatory analysis. NUREG-NRC publishod a proposed rule on The NRC proposed to adopt a new 10 1492," Regulatory Analysis on Criteria criterla for the release of patients Cl? 35.75(b)(1) to require that the for the Release of Patlants Administered administered radioactive material. The licensee provide released patients with Radioactive Material"(May 1994),
proposed rule discussed the public written instructions on how to maintain examined the benefits and impacts of comment letters received on the first doses to other individuals as low as is the pro two petitions. Three additional reasonably achievable if the total NRC. posed rule considered by the comment letters were received on the effective dose equivalent to any third petition (pRM-35-11). These individual other than the released 111. Public Comments on the Proposed letters each supported the petition but patient is likely to exceed 1 mt!!islevert N "I' did not contain any additional (0.1 rem)in any 1 year. A requirement A total of 63 comment letters were information not cosered by the letters to give instructions to certain patients received on the proposed rule, the draft on the first two petition's. was already contained in to CFR regulatory guide, and the draft The NRC proposed to amend to CFR 35.315(a)(0) and 35.415(a)(5), but the regulatory analysis. A majority of the 20.1301(a)(1) to specifically state that proposed requirement would also comment letters were from medical the dose to individual memben of the require instructions for an additional practitioners and medical organizations, e public from a licensed operation does 50,000 ladividuals who are but there were also comment letters not include dosos received by administered lodine 131 for the froin private individuals, public interest individuals exposed to patients who treatment of hyperthyroidism and . groups, and regulatory agencies in were released by the licensed operation another 27,000 individuals who are Agreement States. Overall, the majority under the provisions of to CFR 35.75, breast. feeding and administered various of comment letters supported a dose This was to clarify that the diagnostic and therapeutic radioactive limit of 5 millisteverts (0.5 rem) for Commission's policyis that patient materials. The purpose of the individuals exposed to patients released release is governed by 10 CFR 35.75, not instructions is to maintain doses to with radioactive material, llowever, 10 CFR 20.1301. Individuals exposed to patients as low about one-fourth of the comment letters The NRC proposed to amend 10 CFR as is reasonably achievable, opposed the proposed recordkeeping 20.1301(a)(2) to specifically state that The NRC proposed to adopt a new 10 requirement. The significant comments the limit on dose in unrestricted areas CFR 35.75(b)(2) to require that licensees are discussed below, arranged by does not include dose contributions maintain, for 3 years, a record of the subloct.
4122 Federal kentator / Vol. 02, No.19 / Wedntedty,1:nuary 29.1997 / Rules and Regul:tions l'nlusion of Patient Release frurn taken to redute the dose to as low as is
$ 20.130l(s) bawd limit because the done. based limit reasongbly ach evable. The NRC better exprenes the NRC's primary All the commenters except one reaffirms that previous detenninstion in concern for the public's health and suPIsorted overning nativnt release by this rulemakin . safety. A sin le activi requirement was >
the ulat ons in 10 .R 35.75 and In the case o released intients,it not retained >ccause ifferent would be unlikely for a s ngle radionuclides with the same activity can indiddual exposed to a patient to give very different dor.es under identical I osed o a r losw Pa i i ruin 10 receive a dose in a year of over 5 CFR 20.1301(a). exposme conditions. Likewise, a single Comment. One commenter, mi)tisleverts (0.5 rem) because large dose rate requirement for all there ioutic donos (greater than 3.700 radionuclides was not retained becau'se repreentlig a public.ofinterest objected ,an exposure a mem grou[tmega of uerels(100 uillicuries))are different radionuclides with the same '
the general pu lic who has not usually not administemd more than dor,e rate, at the time of rolesse, can give ;
consented heely to the dosage. They once to the same patient in a given year, ve difrerent doses dependin i said that such exposure would lead to Comment.One commenter said that ha life of the radionuclide. 'Ik, upon the e total widespread morbidity and mortality. the NRC should chaeca ibnn i tem dose dose depends on the effective half.!!fe of flesponse. In its revision of 10 Cl R limit for the public in~10 CFR the radioactive material in the body of part 20 (50 FR 23300; May 21,1991), the 20.1301(a)(1) to 0.5 rem for all licensed NRC detennined that, while dows activities because a done limit of 0.5 rem the kistlent and other factors that very for < ifferent materials. For these offers adequate protection and is a dose should be maintained as low as is a dose reasonably achievable, a dose limit of 1 that has no proven effects. reasons, limit rather than the NRC is establishinbone an activity or rate millislevert (0.1 rem), or a dose limit of firsponse. This issuo of the general limit.
public dose limit is outside the scope of The NRC is establishing a dono limit -
8 millisleverts (0.5 rem)in certain this rulemaking. The issue was dealt special circumstances, provides of 5 millisleverts (0.5 rem) total effective with when to CFR part 20 was recently dose oyulvalent to en individual from adequate protection. The revised part 20 revised (56 FR 23360; May 21,1991). exposure to the released patient for each is based,in part, upon the That rulemaking ex lained the NRC's recommendations of the International patient release. This done limit is Commission on Radiokigical Protection rationale fordon adopt the 1 millislevert consistent with the underlying risk basis (o g. rem) lim n 10 CFR (ICRP) and the recommendations of the of the current to CFR 35.78 (50 FR 20.1301(a)(1). 30027: July 20,1985), the
National Council on Radiation Protection and Measurements (NCRP). Activity. Based vs. Dose-Based Rc;same recommendations of the NCRP and the The NCRP recommends public done 1imit ICRP, and the provisions in to CFR limits of 1 millistesert (0.1 rem) for 20.1301(c) pertaining ta temporary The issue is whether to setnin the continuous or frequent exposure and 8 current patient release limit in 10 CFR situations in which there is fustincation millisleverts (0.5 rem) for infrequent for a done limit higher than 1 exnosure. 38.75, which is expressed as an activity millislevert (0.1 sem).
limit together with an alternative but the ICRP recommends that the limit The NRC believes that the dose-based approximately equivalent limit on dose release limit can and will work well for public exposure abould be expressed rate at 1 meter, or to express the release because the associated Regulator as an effectivo dose of 1 millislavert (0.1 limit as a dose to an individual exposed 8.39," Release of patients Administered rem)in a year, except that, in special ' ta the patient.The majority of Radioactive Materials," can be used to circumstances, the dose could be higher commenters supported the dose-based in a single year provided the average limit. Ilowever, some commenters relate the dose to the quantity of activity '
over 5 years does not exceed 1 in the patient. The Eulde provides opposed the dose-based approach, conservative estimates of activities for millislevert (0.1 rem) per year. In ICRP Commenf. A number ofcommenters publication 60,in defining medical commonly used radionuclides and their said that to CFR 35.75 should not be corresponding dose rates with which a exposure,ICRP stated that medical changed and that the 30 millicurie or 5 exposure includes " exposures (other millirem per hout release criteria should patient may be released in compliance than occupational) incurred knowingly with the dose limits in the final rule.
be retained because they are working and willingly by individuals helping in The approach used in the regulatory well. Some commenters said that a guide is based on NCRP Report No. 37, the support and comfort of patients dose. based release limit as proposed undergoing diagnosis or treatment." " Precautions in the Management of would cause confusion and potential Patients Who llave Received Furthermore, in explaining dose limits in medical exposure, the ICRP stated in problems. One commenter said that the Therapeutic Amounts of part 20 revision was not intended to the same publication that "the Radionuclides."1 In the case oflodine-alter the status quo for patient release. 131, the most significant radionuclide, Commission therefore recommends that Commenters objected to the dose-based dose limits should not be applied to the release quantity based on the <
release limit because they thought the standard conservative anumptions is medical exposurus." Thus, in ICRP's dose estimates to the public would be opinion, family members who are 1.2 gigabecquerels (33 millicuries),
very inaccurate as these estimates are helping in the support and comfort of which is essentially the same as the based on the unreliable method of current release quantity.
patlents would not be restricted under predicting the anticipated time and the dose limit stated above, NUREG-1492 contains a detailed proximity to others. Commenters also examination of the benefits and impacts The revision of part 20 incorporated said that dose estimation and the of the final rule that includes dose the long term ob)cctive as the dose limit subsequent recordkeeping would be
- and included a provisisn ($ 20.1301(c)) time consuming and would add to the ' Nauonal councu on Radiauon l'rotection and to allow for ahernative limits on an cost of treatment without a probable Mumternents (NcRPL Prerautione 14 the occasional basis. Soction 20.1301(c) significant decrease in radiation l provides that an annual dose of up to 5 exposure.
QD*8p'f[,"y,"',*
, *;*"[*$gp millisleverts (0.5 rem) is acceptable if Hesponse. The NRC is adopting a Renn Na st moder i wrot mun.tae for ale from ne NcRP. 7910 Woodmont Avenue. Suite there is a need for it and il steps are dose based limit rather than an activity. om name.d.. uo 20:14-309s 1
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rederd Regist:r / Vol. 02, No.19 / Wednesday, lxnunty 29, 1997 / Rules and Regulations 4123 ntimztlon, recordle: ping, cnd r:dlition double f:mily members' risk of Reg:rding the comment on the exposure. Single copies of the final developing thyroid cancer, doubling of risk of developing thyroid cancer, there is no scientific consensus +
regulatory analysis and Regulatory nerponse. The concem over Culde 8.30 " Release of patients contamination is not justified by the by the United Nations Scientific Administered Radioactive Materials," radiation doses that are Ilkely to be Committee on the Effects of Atomic are available as indicated in the caused by the rmoval of radionuclides Radiation, ICRp, or NCRp to support the ADett6Es heading, from the patient's body by the pathways suggested increased risk of thyroid -
Comment. A commenter said that the of exhaled alt, faces, allva, sweat, cancer following ingestion of iodine. ,
calculational approach in the rule urine, and vomit. Measurements from 131. Hened on the information carmutly ,
would require the physician to ask several studies, as discussed in the available, the Commission continues to many personal questions of the patient, sup}mrting regtdatory analysis, have conclude that the tenefits outweigh the Response. The commenter is incorrect shown that a relatively small proportion potential of small increased risks ,
in believing that the dor,e based of the radioactive material administered associated with thle rule. i approach will generally require pereonal will appear as contamination. Doses to Comment. One commenter noted that information Imm the patient. De NRC family members exposed to hospitals now make great efforts to ta will contamination from living in close e ntalcontamination from patients anticipates be released basedthatonavT a" +ilt defat contact with released patients have been who are now hospitallred because they assumptions which do not require any musund in several studies and in o ntain more than 30 millicuries of personalinformation from the patient. A every case were less than to percent of lodine 131. This commentu stated that ,
table of release quantitles, based on it would not be possible to maintain the the 5.millislevert (0.5 rem) total standard conservative usumptions, is effective done ulvalent limit and were same level of contamination control at irovided in Regulatory Guide 8.39, these patients homesif these patients most often less an i ercent of the S.
Release of patients Administered millislevert (0.5 rem) Ifmit, in addition, wem released with more than 30 Radioactive Materials." llowever, the rnHHeurin oflodine.131, the internal doses resulting from "*
- rule does allow the physician to contamination were always less and '8*" "I' "*" I calculate patient specific dose estimates generally far less than the external done, **d P
, ho I huard to allow early release of a patient not meaning that contamination was the from contamination, contamination otherwise subject to release under the less important source of radiation controlin a hospitsl can be more default values in Regulatory Guide 8.39. exposure.These measurements show effective than contamination control out Comment. One commenter said that it that even if'he family members of the hospital. However, the Iwo .
should continue to be acceptable to repeatedly touched household items situations are not really comparable. In
- release patients based on the dose reto - toucimd by the patient, contamination the case of the released patient at home, at 1 meter. does not cause unacceptably high dosese therapeutic administrations usually Response. %e rule authorizes release These findings were true even in the occur no more than once in a year and of patlents based on the done to an case of a British study where eleven probably no more than once in a individual for each patient release, patients volunteered to disregard special hfetimes but in the case of a hospital, llowever, release quantitles based on precautions agalnst contamination and large therapeutic administrations am dose rate and conservative assumptions minimizing spousal and family done repeatedly on many patients.
can be calculated. The table of release exposure.These measurements are Therefore, arena in hospitals heve the quantitles in Regulatory Guido B.39, discussed in NUREG-1492. Also, the potential for contamination Imm many
" Release of patients Administered NCRp recently addressed the risk of patients, and people who frequent the Radioactive Materials," specifies the intake of radionuclides imm patients' hospital (e.g., clergy or a hospital dose rate at 1 meter of commonly used secretions and excreta in NCRp orderly) have the potential to be radionuclides that allow licensees to Commentary No.11. " Dose Limits for exposed to contamination from many authorire patient release. Individuals Who Receive Exposure imm patients in addition, the 5.millislevert Radi nuclideTherapy atients,"andp (0.5 rem) hmit that is applied to Release Quantitles concluded that,"' '
- a conteminatim household members exposed to a Using a dose-based system based on a incident that could lead to a significant patient is a speciallimit that is dose to the most highly exposed intake of radioactive materialis very appropriate for only occasional use and individual of 5 millisleverts (0.5 rem) unlikely."8 for use where there is a definite need, would,in some circumstances, allow in general, the physical reactions (e g., nis special limit fits the case of doses release of a patient with snore than vomitingl that a patient may experience received by the household members of 1,110 megabecquerels (30 millicurles) of from the administration of any a released patient, but does not fit the activity. Some commenters were radiopharmaceutical are rare. Vomiting case of people who frequent a hospital opposed to allowing releases with is seldom an important elimination on a routine basis. Lastly,in limiting blgher activities than are now - route for radiopharmaceuticals after the dosca the NRC considers what is permitted. patient has leit the medical facility since reasonably achievable. The mere fact Cornment. Several commenters said orally administered that a home cannot control
! that the release of patients with more radiopharmaceuticals such as lodine. contamination as well as a hospital does than 30 millicuries of lodine.131 should 131 are rapidly absorbed, within a hall not mean that the contamination control not be permitted because of concerns hour. by the gastrointestinal system, achieved in homes is not adequate.
about the risk of internal exposure. One Actual measurements of doses to commenter said that doses to family . w.iion,i co,neti on e,dt.ii., proi.ciion .nd husehold members from members from the patient vomiting M uremenia ~tk.e I.imits for individu.i who contamination, as discussed in NUREG-
! were not adequately considered. The Receive Exposure from Radionuc hde Therapy 1492, show that the doses from same commenter also said that a study 1 f8 indicated that in home contamination Q'g'[jC$,0C".[s*,'Q.
woodmnnuv nu.. suit oo d.,ii.th Ma$by' that
'o *-thecontamination are control degree of contamination low, demon by patients dosed with 1-131 could rosis.wm that was achieved is adequate.
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4124 l'ederal Resi:t:r / Vol. 62. No. to / Wednesday, January 29, 1997 / l<ules and Regul:tions hew +%-- sp -e-y-m- emin e e- s quesue m. .rms--e-% =-a.
Comment. One commenter said that might be beneficial and acceptahle to individual likely to roccive the highes the proposed rule did not adequatsly family merr.bers. Another commenter donc if the dove to that person is likely eddress the concerns that the Agreement said that a dose of 0.5 rem to an to exceed 1 millislovert (0,1 rem). Under States expmsud on the petitions for individual expored to a patient has so the propowd rule,if a patient had or rulemaking concerning releasinR little harard that the NRC should not be might have had one or more pitlents with quantitles of lodine 131 in concerned with it. administrations within the same year.
l excess of 30 millicuries, llespotise. The NRC does not believe the licenwe would use the records to l
Ilesponw. In commenting on the that individu)ls ex determine the dose from the previous petitions, a number of States expressed should,in general,powd to pinpatientadministrations so that the total dose to receive doses concerns about teleasing patients excess of 5 ruillisleverts (0.5 rem). This an individual exposed to a patient from cdministered 14.8 gigabecquerels (400 is consistent with the recommendations all administrations would not exwed 5 l millicuries) of iodine 131, which one of of the ICRP in ICRP publication 60,8 millisleverts (0.5 rem).
i the potilloners had requested. Ilowever, "1990 Recommendations of the Comment. Many C.ommenters the States that commented were International Commission on indicated that this requirement would generally favorable to the proposed rule Radiological Protection": and the cause excessive costs in time, effort, and litulting the dose to the most exposed recommendations of the NCRPin NCRp money to track down records of I
individual to 5 millisleverts (0.5 rem), Report No.110,* " Limitation of previous administrations, to perform l cnd none of the States indicated that Exposure to loniting Radiation." Each calculations, and to keep records of all their concerns were misrepresented. In of these recommendations provides a the work and asked that the f:ct, one Agreement State commented basis for allowing individuals to receive requirements to make calculations and that it was pleased that the NRC had annual dows up to 5 millisleverts (0.5 keep records be removed. The considered the comments made by the rem) under certain circumstances. Both commenters believed that the work Agreement States at various meetings the ICRP and the NCRP recommend that would not produce an increased level of with the NRC. The dose-based limit an individual can toccive a dose up to t.afety, that the NRC greatly would generally permit releases if the 5 r71111steverts (0.5 rem) Art a given year underestimated the cost, and that the i
' dose to another individual would not be in situations when exposure to radlation recordkeeping would be unnecessary, likely to exceed 5 millisleverts (0.5 is not expected to result in doses above inappropriate, and impractical. Some rem). For example,if a licensee uses the 1 millislevert (0.1 rem) per year for a commenters said that multiple .
default table of release quantitles lot.g period of time, as would be the administrations that would result in a ,
provided in the regulatory guido as the case for doses from released patients. In total effective dose equivalent greater tests for release, a patient administered NCRP Commentary No.11 Dose than 1 millislevert (0.1 rem) are not 1.2 gigabecquerels (33 millicuries) or Limits for individuals Who Receive done to the same patient routinely, less of lodine 131 could be immediately Exposure from Radionuclide Therapy Other conunenters said that there have released and no record of telease is - Patients,"8 the NCRP recommended a been decades of experience required. Ilowever,if the lleenwe dose limit of 5 millisloverts (0.5 rem) unencumbered by any peerwork wishes to release a patient with an annually for members of the patient's burden at all with no evidence that a tetivity that is greater than the value in family. Ilowever, on the lack of paperwork has resulted in any the default table, the licensee must do recommendation of the treating additional problems. One commenter j a dose calculation using case-specific physician, the NCRP considered it said that if 0.5 rem is acceptably safe, t IIctors to demonstrate compliance with acceptable that members of the patient's why have the documentation required at I the release criteria. Furthermore,if the family be permitted to receive doses as the 0.1 rem level.
ttble is used as the basis for release but high as 50 millisleverts (5 rems). The Another commentor said that it
' the administered activity exceeds the NRC does not agree that the latter NCRP cannot be a licensee's responsibility to value in the table, the licenne must recommendation should apply in know the details of a radionuclide hold the patient until the time at which general. The NRC believes that if the therapy performed by another licensee the retained activity is no Emater than dose to another individual is likely to in terms of which members of the public the quantity in the table or the doso rate exceed 5 millisleverts (0.5 rem), the received the most radiation dose from -
et 1 meter is no greater than the value patient should remain under the control that other licensee's therapy procedure.
In the table. When the administered of thelicensee Licensee controlls one commenter said that the cctivity is greater than the value in the necessary to provide adequate excessive recordleeping cost would be default table, a record of the basis for protection to the individuals exposed to a nontelmbursable cost, and the burden the release must be maintained for NRC the patient. will cause many physicians to stop review during inspection. Regardless of offering lodine therapy, which would the method und by the licensee to 0" P "8 I
force patients to travel to lhrge medical authorire release, the dose limit of 5 The strongest opposition to the facilities in cities and cause problems millisleverts (0.5 rem)in the reviwd 10 proposed rule was to the proposed with patient access in sparsely CFR 35.75 applies. Ily identifying more regulrement to maintain a record of the populated areas, than ore method for calculating the . released patient and the calculated total flesponse. Upon reconsideration, the release of a patient in accordance with effective dose equivalent to the NRC has decided to delete the 10 CFA 35.75, the NRC provides greater requirement to keep records when the flexibility for lleensees to achieve niernauonal comminion on hdioioskal dose to the most highly exposed j compliance with the new requirement $l),'@,',",,"*2'7" day y * *'"* Individualis likely to exceed 1 while still providing adequate Prm. coon.1CRP PehraCon No. e0 (Novemtet millislevert (0.1 rem). The requirement a protection of public health and safety, um Avenetd for ute from Perpman Pren.Inc., was proposed so that it would be
- Cominent. One commenter said that Elmsford NY 105n possible to account for the dose from in some cases it should be pennissible Nanonal Councu on bdiadon Protecuan and multiple administrations in the same to authorin the release of a patient even [',Q"gy,*g,(jl'[gfg,y'gaf*["f year to ensure that the total dose to an if the dose to a family member might Auualde for une trom the NCRP r910 Woodmont individual exposed to the patient did exceed 0.5 rem because the release Annue. suae neo, nathesda, Mu rnaisaous. not exceed 5 millisteverts (0.5 rem).
f l
l
1 Federal Res(6t:rgol. 02, No.19 / Wednndzy, lxnuary 20. 1997 / Rules and Regulttions 4125 The NRC has an advisory con mittoe, Response.The commenter is correct considered to be a part of the practice tha Advisory Conm.ittee on the Medical The Statement of Considerations was in of medicine." The final nale is Uses of isotopes, or "ACMUI," which error on that point. The existing consistent with this statement because it advises the NRC on rulemakings and togulations do not specify that does not dictate the cholce of medical other initiatives telsted to the medical inattuctions have to be in written fonn, treatment or diagnosis, does not specify use of byproduct materials. The NRC Comtnent. A number of commenters the details of what the physician must also has a visiting medical fellows sold that instnictions should not need to say or must include in the contents of be weitten and that oral instructions the written instructions, and is directed .
program that recruite selected '
physicians or phannacists to work for should 1e pennissible. Some of these at minimiting the risk to the patient's the NRC for a period of 1 to 2 years, cornmenters said that oral instructions family who have s o doctor. patient 110th the ACMUI and the current are more effective and that how the relations to the prescribing or Visiting Medical Fellow, Myron instructions should be given is within administering personnel. Ilowever, Pollycove, M.D., provided advice to the the province of the doctor patient Regulatory Guide 8.39," Release of .
NRC during the develop *nent of this rtlationship and that the NRC andits Patients Administered Radioactive Matedals," recommends contents of the rule. In addition. Ilarry A. Slopel, M.D., regulations should not interfere with former Chainnan of the ACMUI, that relationship. One commenter said written instruc%s . . _
rev;ewed the patient records at his that the physicalcondblon of the Further discussion of the 1979 medical facility for the 1. year period patient could lessen the patient's ability Medical l'olicy Statement is presented to follow the instructions. Another under the heading, " Vill. Concistency from July 1.1993, to June 30,1994 with 1979 Medical Polley Sta.ement."
(Mallincirmit institute of Radiology, St. commenter said that the standard Comment. Several commenters asked Louis, Missouri). Drs. Siegel and written instructions requlte too much Pollycove concluded that no common time explaining how each patient varied whether written instructions were from the standard instruction sheet, appropriate if the patient was blind, nuclear rnedicine practice, be it 1111terate, or did not read English.
llowever, one Agreement State and a diagnostic, therapeutic, or a Another commenter said that the
. combination of the two,results in major health maintenance organization multiple large administrations that strongly supported the requirement that instructions should be both written and ,
the instructions be written. oral and abouldim in the primary 1 would be likely to cause the 6 language of the patient.
Response. The NRC believes that millitievert (0.5. rem) dose limit to be pr viding written instructions has a Response.The NRC believes that exceeded because of multiple significant value locause often patients written instructions are useful and administretione in a year, will not remember all of the instructions should be required. If the patient is While the proponed utrement tu iven orally,in addition, written blind, Illiterate. or does not read maintsin a record of the one to another fnstructions can be read b other family En lish,it is likely that someone else individual if the dose is likely to exceed members or care givers e wi ! be able to read the instructions for 1 millislevent (0.1 rem) has been requinment to provide the instructions the patient. NRC considers it too muc'o >
deleted, a secordkeeping requirement in written form was also supported by of a burden to require that the with a reduced impact has been retained the ACMUI. Instructions be given in the primary as discussed under the heading, This regulation allows the licensee to language of the patient, although the
" Discussion of Text of Final Rule.,, determine the form of the written regulations do not preclude foreign Comment. Several commenters aid instructions. The NRC believes that for language written instructions if the that those who pay for health care will the majority of releases requiring licensee rhooses to provide them,in put great pressure on physicians to written instructions, the written most situations,it will be possible to optimize calculations to reduce in, instructions can be prepared in a find someone who can translate for the patient days and to justify out. patient generic form. For example, the Society patient if necessary. The requirement treatments, of Nuclear Med! cine has prepared a that written instructions be given to the Response.There is no objection to brief pamphlet," Guidelines for patients patient does not preclude additional optimizing calculations to reduce in- Receiving Radiolodine Treatment," oralinstructions, patient days as long as the calculations which csn be given to patients at Comment. Several commenters asked are realistic and the 5 millislevert (0.5* nominal cust (less than $1 per pattut). how the NRC would enforce rem) limit in to CFR 35.75 is met. Ilowever, oral instructions may also be implementation of the instructions _
Regulatory Guide 8.39," Release of provided in all cases, given to the patient. Another commenter patients Administered Radioactive Comment. Several comtnenters said asked how the licensee could verify that Materials," describes examples of that dictating to a phystrian how and the instructions are followed. Another calculations that are acceptable to the what he or she must tell a patient is not commenter said that a sizable fraction of NRC. the purview, mandate, or competence of patients may not follow radiation safety the NRC and interferes with an essential instructions to protect spouses and may Written Instructions To Patients part of medical p.actice, which is be even less careful about protecting in general, there was little objection to communication between physician and total strangers. This commenter also providing instructions to patients on patient, asked whether it is reasonable to expect how to minimize the dose to others, but Response,in a policy statement ' that released patients will alter their there was significant opposillon to the
- published on February 3,1979 (44 FR behavior and limit their activities for the proposed requirement that the 8242), entitled " Regulation of the protection of others.
Instructions would have to be written. Medical Uses of Radioisotop"es: Response. The NRC does not intend to Comment. One commente; said that Statement of General policy, the NRC enforce patient compliance with the the Statement of Considerations for the made three specific statements. The instructions nor is it the licensee's proposed rule was in error in stating third statement of the policy is "The responsibility, liowever,it is the that the existing regulations already NRC will minimite intrusion into responsibility of licensees to provide required that the instructions to patients medical judgments affecting patients instructions to the patients. Following and into other areas traditionally the instructions is normally the be written.
4126 Federal Regist:r / Vol. r.2, No. to / Wednesdzy, January 29, 1007 / Rules and P.egulations
___ -u_ _ _ _ _ _ _ _ __ __ . _ _ ,
1 responsibility of the patient. However, llesponw.These canmenters the public henhh and safety, and that !
American snedical practice routinely misunderstood the cor ocpt of responsibilits estends to allindividuals !
depends on patients following confinement. As explained in the exposed to *. patient administered instructions, such as lustructions on Statemen' of Considerwtlons for the licensed rtdioactive materials, when and how to take medications. propowd rule (59 FR 30724), the term including breast foeding children. When With regard to compliance with the confinement" no longer applies to the the relcae is authorized, it is based on
- instructions, surveys of patients and revision to 10 CFR 35.75. Instead, the the licensw's determination that the
- their spour,es, as discus 6ed in the test of the rule uses the phrase "licenwe total effective dose equivalent to an supporting regtulatory analysis, indicate umtrol" to more clearly reflect the ind.vidual from the released patient is that most will attempt to follow the NRC's intent. nr a likely to esceed 5 millisleverts (0.5 instructions faithfully, especially with The NRC believes that there is a rem). The dose to the breast. feeding regard to protecting their children, distinct difference between a patient child from breast.fooding is a criterion tilhough some patients and their being under licensee controlin a for telease but it can be controlled by 3 spouses indicated that they might not hospital or other licensco facility (e 8A giving the woman guidance on the keep physically distant from their hospice or nursing home) and being at intenutition or discontinuation of nome. m (ubpital or other area or spouse for prolonged periods of time. breast. feeding, as required by the new
, Comment. One commenter said that address of use listed on the NRClicense, 10 CFR 35.75. llowever, the release ,
a instructions should be given for all the licensee has control over access to could be bued on the default table of
- cdministrations of radioactive material, the patient as well as having trained release activities in the regulator regardless of the quantity administered. personnel and instrumentation available or a patient-specific calculation,y as guide Response. The NRC does not agree. In for making radiation measurements not required by the new 10 CTR 35.75<The como cases, particularly in the large typically available at the patient's home. lasue of the dose to the breast. feeding number of diagnostic administrations, in addition, while under licensee child is discussed in NUREG-1492 and the potential Jones are so small that the control, a licensee has control over the Regulatory Guide 8.39 " Release of burden of requiring instructions cannot dose by limiting the amount of time that patients Administered Radioactive be justified. Under the final rule,if the individuals are in close proximity to the Materials." '
' dose to any individual exposed to the patient. A patient who goes home in Comment. One comrnenter said that patient is not likely to exceed 1 released from licensee control, the proposed rule did not accurately millislevert (0.1 reml, instructions are Comment. One commenter thought wpresent the position of the Advisory
- not required but the physician could that the rule should define the term Committee on Medical Uses ofIsotopes.
4 give any instructions that he or she "telease." llesponse. A review of the transcrfpt j considers desirable. Ilesponse. The term " release from for the ACMUI meeting in May 1992 Confinement of patients licensee t<mtrol," when read in context, shows that the rederal Register Notice refms to radiation protection p+ovided an accurate description of the j Cornment. Two commenters asld that considerations and is sufficiently clear ACMUI position. The final rule was patients cannot be confined against their that there is no need to define the term. discuned with the ACMUI on October 18,1995, and the ACMUI,in general,
- wishes penalty for theand thatw the patient rulo !irovides m leaves Miscellanmus no Comments on the Rule supported the rule. (For ACMUl's confinement in the hospital "against Comment. Several commenters said comments and NRC's responses, soo
- rnodical advice." Another commenter that the rule should not be a matter of Section V. Coonlination with the said that the rule seems to require that Agreement State compatibility at any Advisory Committee on Medical Uses of the licensee have control of the patient's level. Isotopes.)
cctivities after release. Ile8Ponse. The NRC does not egree. Cornment. One commenter said that l Ilesponse.The NRC recognizes that The NRC conducts an assessment of its facility treated many foreign patients patients cannot be held against their each proposed requirement or rule to with therapeutic pharmaceuticals.
, will. The rule deals with the conditions determine what level of compatibility These patients frequently may leave the 1
under which the licensee may authorize will be assigned to the rule. These case- hospital and immediately board a plane
- release. The NRC would not penalize a by case assessments are based, for the to return home. Thus, there is a limit to 1
licensee for the activities of the patient most part, on protecting public health the amount of control that a licensee has efter release or if the patient were to and safety. NRC has evaluated the final over the patient, leave "against medical advice." rule and assigned compatibility liesponse. The NRC recognizes thit Cormnent. One commenter asked designations ranging from level 1 (full the licensee hns no control over the ;
whether a patient who was releasable compatibility required) to level 3 patient after the patient has keen
. but was still hospitalir.ed for other (uniformity not required) as detailed released. The quantitles for release reasons would still be considered under later in this rederal Register notice. listed in Table 1 of Regulatory Guide the licensce's txmtrol, Comment. Several commenters said 8.39," Release of patients Administered Ilesponse. Once the licensee has that a breast fooding infant should not Radioactive Materials," were calculated authorleed the relose of the patient, he considered as an individual expored using conservative assumph ons (for
, there is no need to keep the patient to the patient for the purposes of example, by using the physical half. life under licensee control for radiation ~ determining whether patient release o(the radioactive material rather than protection purposes if the patient may be authorized. These commenters the more realistic effective half life).
remains hospitallred for other reasons. said that consideration of the breast. Thus, the NRC considers it unlikely that liowever, good health physics practice feeding infant should be under the the dose to an individualin real would be to continue to make efforts to jurisdiction of the physician, that the circumstances would approach 5 maintain doses to people at the facility issue is a medicalissue rather than a millisleverts (0.5 rem).
2 as low as is reasonably achievable, regulatory issue, and that the NRC In special situations, such as when a Comment. Commen'ters also asked should not interfere in medical issues, released patient would immediately how a patient can be confined to his or lfesponse. The NRC does not agree. board an airplane and would therefore hot house. The NRC has a responsibility to protect be in close contact with one or more 1
- _-....,m.._ , _
. ..,_m, , , . . _ . , _ ,_ , , . _ , , _ . - , ~ , . . . _ , - ~ _ _ , - .- ,..~ ,.,_ -_ . . _ . . -
federal Regist:r / Vol. 02, No. tu / Wednosd:y, Jtnutry 29, 1997 / Rules and Regulations 4127 Individuals,it sney be necessary to base motbodology in thu table giving default of thyroid cancer is too lart;e and that the release on a more realistic case- releano quantition is intended to be the correct value should be 0.05 or less.
specific calculation. Once the patient is conservative. The NRC believes it is Another commenter said that the released, the responsibility for following appropriate and prudent to be biological half. life of extrathyroidal the instructions is entirely the patient's, conservative when providing generally lodine should be 0.5 day for both the not the licenwe's. applicable release quantitles that may be cuthyroid and hyperthyroid condition, used with little consideration of the One commenter said that the biological Comments on the Draft Regulatory specific details of a particular patient's half lives frorn ICRP Publication No. 53 Guide should be used for thyroid cancer.
release. A review of published Comments were also r uested on information, as described in the lies;onse. The NRC sgrees that the Draft Regulatory Guide, not5. regulatory analysis, NURI G-1492, commenters raised valid points. In
" Release of Patients Administered "Rogulatory Analysis on Criteria for the Regulatory Guide 8.39, the iodine Radioactive Materials," associated with Release of patients Administered retention fraction for thyroid cancer was this rulemaking. Ilocause the guide is Radioactive Material" (1997), finds that changed to 0.05. The biological half life associated with the rule, the comments measured doses are generally well for the extrathyroidal fraction was received on the draft guide are below tnose pmuRwu uy the . , changed to 0.33 day. In addition, the discussed here. Most of the comments methodology used to calculate the table biological half.livos from ICRP concerned the method and the of default release quantitles Thus, the Publication No. 53 were used for the assumptions used to calculate the dose default release quantitles are thyroid cancer case, to the individual likely to receive the conservative as the NRC intended. Comment. One commenter said the highest done. Ilowever, the licensee is given the table of release quantities in the draft Comment. Several commenters said option of using case specific , guide should be expanded to include
,t hat the nelculational methodology in - calculations that may tie less bets e.nitters such as strontium-89 and the draft guide is too complex and that conservative, phosphorous 32. Another commenter the assumptions are too conservative. Nevertheless, the NRC agrees that the said that the table should be expanded As an example, several commenters said assumption used in the draft guide of to include chromium.51, solenium.75, -
that the assumed 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> nonvoiding 24. hour nonvoiding in the thyroid yttrium.90, itn.117m, and iridium.192.
assumption used in calculating doses is cancer example was overly flesponse. Values for the beta emitters too conservative. As evidence that the conservative. The revised example uses stmntium.89 and phosphorous 32 have calculations are too conserystive, an excretion half life of a bours as been added to the table of release several commenters said that the doses recomm nded by the ICRP in ICRP quantitles in Regulatory Guide 8.39. The measured using dosimeters were much Publication 53," Radiation Dose to table of release quantitles was also lower than doses calculated using the Patients from Radiopharmaceuticals."s expanded to add values for chromium.
models in the draft ulde. Comment. One commenter said that 51, selenturn 75, yttrium-00, tin.117m.
Elesponse.The Ni C has revised the the occupancy factor (generally assumed and iridium.192.
guide to use a phased approach for to be 0.25 at 1 meter) should not be left Comment. The table of release determining when release can be to the discretion of the licensee because quantitles in the draft regulatory guide authorized. While the calculations can low occupancy factors could easily be should be expanded to include sometimes be complex, the results of justified by providing strict safety acuolerator. produced radioactiv calculations that use conservative Instructions without any verification materials as an aid to Agreement States, assumptions are given in a table of that the instructions will be followed, liesponse. Several accelerator-release quantities in Regulatory Culde Another commenter liked the flexibility produced materials were added to 8.39," Release of patients Administered provided by being able to adjust thg Regulatory Guide 8.39 as an aid to the Radioactive Materials." Of the 8 to 9 occupancy factor, but wanted to know if States and to medical facilities. The l million administrationa performed other considerations are allowed and if NRC has no regulatory authority over annually,in all except about 10.000 it is acceptable to use values lower than the releas; of patients administered cases (radiolodine therapy for thyroid 0.125. accelerator produced materials and l
cancer), release can be authortred based flesponse. Draft Ryulatory Guide 8.59 would not inspect the release of patients l on conservative assumptions and using discussed situations in which it might administered accelerator.produesd Table 1 with no calculational effort on be perminible to lower the occupancy materials.
the part of the licensee and no factor from 0.25 to 0.125, but did not Comment. One commenter said that additional recordkeeping beyond what recommead occupancy fardors lens than the regulatory guido should have a table is already required. I'or permanent 0.125. Occupancy factors less than 0.125 of releano quantitles based on biological implants, the guido provides dose rates may be difficult to lustify because it is half life rather than only the physical at 1 meter from the patient at which generally not realistic to assume that the half. life, release mty be authortred. Thus, for patient can avoid all contact with flesponse. Regulatory Guide 8.39 now implants, there would be no oibers, llowever, lower values for the provides more information on release i calculational effori needed, in addition, occupancy tactor are not prohibited by quantities for iodine-131 based on the guide provides information on the mgulation, but they must be justified biological half lives.
iodine thesapy for thyroid cancer that in the record of the calculation, as the Comment. One commenter said that can be used for determining release record will be subject to inspection, the factor of 10" used in the draft based on retention and elimination. Comment. Several commenters said guide to Ostimate internal dose is not l This additional information in the guide that the iodine 131 retention fraction of well supported for nonoccupational ,
will allow the licensee to perform the 0.3 used in the draft guide for treatment exposures. Another commenter said that l calculation with relatively little effort. - the calculation of dose to individuals With regard to the comments that the 'intun.oonal commin. ion on Radiohisical exposed to the patient ignores the ;
methodology la too conservative and that measured values are lower than IM[
cum inn ,"gjdy,d.i*ypjl[,$'s"{'[""
ay.n.ta for .o. trom rogamon potential excretionof radiationmaterial of radioactive donefrom from the calculated by the methodology, the rmi. ix.. umitmd. NY 1em the patient, and this could present a l
1 21l Ted:r:I R: gist r / Vol. 02, No.19 / Wednesdsy, Janunty 29, 1997 / Rules and llegulations significcnt rzdiological her.ard to f:.mily Comment. Severzl commenters uked person. rem (at a value of $2,000 per memben. whether multipleindividual Response. It is true that there is not penon rem)corte calculations have to be done or if a about 55 million nimnds to a cost of a great deal of information on the use of generally applicable calculation could the factor in nonoccupational settings, be done once and used for many NUnt'G-1492 contains a detailed but measurements (descriled in patients discussi n of the model and the benefits NUREG-1492) have leen made in Nesponse. The NRC believen that and impacts of the dose based limit.
which lodine uptake wu measured in there may be some situations for which o copies of um Anal mgulatory people exposed to a patient. These data a case specific calculation could be $1nfysis are available as indicated in the ana suggest that the fractional uptake of the done for a class of patients. The record e D m sheading.
administered activity will be on the for a particular patient's rescase could Cormnent. One commenter said that order of 10*
- Since iodine is among the then reference the calculation done for the benefits of the rule were 4 most soluble and volatile 0.3 class of patients. Ilowever, overestimated because the length of radiopharmaceudcals,it can be depending on a patient's individual time that a thyroid patient would have '
expected that the transfor to others of status (e.g., lower occupancy factor), to remain in the hospital was
"~ less soluble and less volatile there may be cases when the calculation overestimated and the cost of a hospital radiopharmaceudcols would be less will be done for a specific individual; toom was overestimated, being $450 por than that of lodine. Cornrnent. One commenter said that day rather than $1,000 per day as -
In addition, the NCRP recently the discussion on radiolabeled assumed in the draft regulatory analyals.
concluded that, for individuals exposed antibodies in the draft guide was wrong Response. The commenler is correct to redlonuclide therapy patients, the because antibodies labeled with lodine- that the benefits of the rule were risks of externalirradiation and + 131 will be delodinated in the body and overestimated. The estimates in the "
potential contamination are ininor from the lodine will behave like other lodine.
a pbblic health viewpoint therefore a ulatory anal None of the radiolabeled antibodies now draft hospitatef'ir.ation m ed ufr'did sisnotofinclude days of significant intake from t contamination being developed or planned for the biological eliminadon of the radioacuve incident is very unlikely.s future should have an internal dose Comment. A medicalorganization batard for the eneral public, matental; on1 radioactive decay was commented that the draft guide is not Response. T e NRC agrees with this considered. e a consequence, the draft g
cornplete and does not provide Cort, ment. Statements in llegulatory . E,uga '
- ,,gt 'l e t lp '$ts sufficient comprehensive examples to Gulds 8.39 are now modilled. ws ma as at licensees in complying wlth the would need to be retained under Comments on the Draft Regulatory licensee control, and themfore the costs liesponse. The NRC has expanded the Analyela paMMW3) of patient retendon were too high. The guidw to include information and further Comment. One commenter said that final regulatory analysis corrects the examples on the bioh>gical elimination the value of a person rem should be $40 estimates.
oflodine 131 and on wbon guidance on rather than $1,000 as used in the draft The NRC believes that the cunent cost the interruption or discontinuation of mgulatory analysis for the purpose of of $1.000 per day for a hospital room is breast. feeding should be given. evaluating the costs and benents of the not an ovenetimate. Under 10 CFR Expanded examples are now given in rule. The commenter cited a 1993 35.315(a)(1), licensees are required to Regulatory Guide 8.39. " Release of flealth physics Society position paper as provide a private room with a private patients Administered Radioactive a reason that the value should be $40 sanitary facility for each patient Materials." The example on thyroid pu penon rem. receiving radiopharmaceutical therapy cancer was revised to include more IIUPonse. The Commission recently ' and hospitalized for compliance with to realistic assumptions, and an additional adopted a value of $2.000 per person- CFR 35J5. Considering this NRC example on hyperthyroidism was tem na explained in Revision 2 of requirement and the recent reference added. The NRC belleves that the- NUREG/IIR-0058," Regulatory Analysis cited in the final regulatory analysis on examples provided illustrate the Guidelines of the U.S. Nuclear the cost of hospitahzation, $1,000 per techniques sufficient to perform the . Regulatory Commission (November day for a hospital room is a reasonable whole range of potential calculations. 1995)," Section 4.3.3," Evaluation of estimate.
Comment. One commenter said that Values and impacts."(Single copies of NUREG/IIR-0058 are available as Conunent. One commenter said that the draft regulatory guide did not the description of the measured doses provide enough information on when indicated in the ADDRESSES heading.)
and for how long breast.fooding of The draft regulatory analysis, which was received by family memlers was not prepared utilizing $1,000 por person. consistent with the reference cited.
Infants Ilesponse.should be ulde Regulator) intertudsind.
8.39 has rem, employed a simple computational lle8Ponse. The communter is correct, been greatly expanded with respect to model using the physical half. life only An incorrect reference was given. The information on the breast. feeding child, of radiophannaceuticals. The regulatory final regulatory analysis provides the including a table on recommendations analysis has been revised to include use correct reference, for the interruption or discontinuation of $2,000 per person rem, as well as a IV, Coordination With NRC Agnement of breast feeding for specific more realistic dose model based on States radiopharmacocticals. biological retention and elimination of Comment. One commenter said that the radiopharmaceuticals.The more The NRC staff discussed the status of the sample instructions in the draft realistic model with a value of $2,000 this rulemaking effort at two public guido concerning implants should continues to demonstrate the cost. meetings:The Agrooment State include a picture of an implant seed, effectiveness of the dose-based limit. Managers Workshop held on July 12-14, Ilesponse. The sample instructions Specifically, the savings in hospital 1994, and at the All Agreement States were not expanded to include this costs under the earlier release thne Meeting held on October 24-25,1994.
because of graphics limitations, but allcwed are estimated at $14 rnillion. The Agreemem States expressed no -
licensees may add photos if desired. whereas the collective dose of 2J40 objections to the approach in this rule.
fed:ral Regist:r / Vol. 62. No.19 / Wednordry, Jrnuzry 29, 1997 / Rules and Regul:tions 4129 Y. Coordination With the Advisosy not include doses roccived by changes are supported by the Committee on Medical Uses ofInc.> pes individuals exposed to patients who recomrnendations of the ICRP and NCRP The Advisory Committee on Medicci were released by the licensed operation that an individual can receive an annual Uses of isotopes ( ACMul) is an advisory under the provisions of to CFR 35.75. dose up to 5 millisleverts (0.5 rem)in body established to advise the NRC staff This is not a substantive change. It is a temporary situations where exposure to on matters that involve the cladlying chanf,e tu make clear that the radiation is not expected to result in administration of radioactive material Comsnissimvs policy is that patient annual doses above 1 millislevert (0.1 and radiation imm radlonctive motorial, releen is gaverned by 10 CFR 35.75, not rem) for many years. Usually, the only The NRC staff presented a sum' mary of 10 CFR 20.1301. Individuals likely to exceed a dose of 1 Fu the sake of consistency and millislevert (0.1 rem) will be those who the comments the ACMUI duringon the icprofsowd a pub meeting rule to clarhy, the name words are used in are aware of the patient's condition such held in Rockvill Mar land $ 201002,
- Scope i in i 20.1003, u tb primary cawgim, a family November 17 and 18,1994. ' " " Definitions"(in the definitions of both member, or any other individual who Drafts of the final rule and regulatory ublic done aml occupational dost); and spends significant time close to the guide were discussed with ACMUIin fn $ 20.1301, , Dose lim,1,ts for individual patient.
ggvigle. Ma , land, on October to and members of the public. Also for This dose based rule would,in some 19,1995.The CMUI supported the and clarit consisten$ackgroumfr,adiation dose from andthe exclusion with activities ofthan greater instances, currvntly permit the r approach in this rule but suggested some clarifying chan es. The NRC etaff from voluntary partici allowed. This is especially true when maarch pro made all but one of I io suggested included in f, rams thafution in medical are now case-specific factors are evaluated to l 20.1002 and 20.1003 are anore accurately assess the dose to'other changes.,The ACMUI suggested using added to $ 20.1301(a). In addition, the individuals. The individuale e.xposed to the tenn rationale instead of ublic " as consequences
- in the requirement definition of"FRmember 30038 on of the fulythe 13,patient could under the revised to CrR 35.75(b), to published in 60 than if the patient hadroccive higher doses $d been hospitallr 1995,is avised by removing the longer. These higher doses are balanced provide " guidance on the interruption footnote which read,"Except as by shorter hospital stays and thus lower or discontinuation of breast.fooding, and delineated in other parts of to CFR health care costs in addition, shorter informatitm on the consequences of-Chaplet 1." With the publication of this hospital stays may provide emotional .
failure to follow the guidance" for cases rule that footnote is no longer needed. benefits to patients and their familin.T where failure to follow the instructions The NRCis amending to CFR Allowing earlier reunion of families can could result in a dose to the infant ' 20.13p1(a)(2) to state specifically that improve the patient's state of mind, exceeding 1 millislevert (0.1 rem). Since the limit on dose in unrestricted areas which in itself may improve the .
most of the administrations that would does not include dose contributions be affected by this requirement are outcome of the treatment and lead to the from individuals administered delivery of more effective health' care, technetium 99m admlnistrations, the radioactive material and released in ACMUI suggested the change because The release criteria in 10 CFR 35.75(a) accordance with to CFR 35.75. The could prevent a woman from being there was concern that the purpore of this change is to clarify that pleased because of the potential consequences of low doses of radiation after a patient has been released under transmission of radioactive materials in i cannot always be explained to the 10 CFR 35.75,licen cos are no longer breast milk. The done to the breast. . ,
patient without causing unjustified required to control radiation from the feeding child is controlled by giving the l alarm. Also, there was concem that atient. The regulation uses the term l physicians cannot explain with p* individual" to refer to the individual 35.75(b).
to womsn onguidance, as required the interruption or by 10 CFR
! certamty the effects of low donos of whom the endloactive material has been discontinuation of breast feeding and l radiation, such as would be caused by administered rather than " patient" to information on the consequences of ,
diagnostic administrations of clarify that the regulation reints to failure to follow the guidance. The technetium 99m. The staff did not anyone receiving a medical expectation is that the woman would i i
change the rule in response to the administration, follow the instructions and would ACMUI comment. The requirement to The NRC is amending 10 CPR interrupt or discontinue breast feeding.
provide information on the 20.1903(b) to use the term " licensee Finally,10 CFR 35.75(a) includes a consequences is included primarily to control" rather than " confinement" footnote to inform licensees that the protect the breast feeding infant from because the latter tonn no longer applies NRC has made available guidance on therapeutic administrations of to 10 CFR 35.75. The conforming change rule implementation. The footnote states radiolodine, which co'uld cause serious is necessary since the term "l;censee that Regulatory Guide 0.39. " Release of thyroid damage. Regulatory Guide 8.39 control" more clearly reflects the NRC's pafients Administered Radioactive will contain guidance on the types of intent in 10 CFR 35.75. Material,"contains tables of activities information, including expected The NRC is adopting a new to CFR not likely to cause doses exceeding 5 i
consequences, to be provided to patients 35.75(a) to change the patient release millisteverts (0.5 rem) and describes i
to meet this requirement. Transcripts cf criteria from 30 millicuries of activity in methods for calculating doses to other
! the meetings have been placed in and a patient or a dose rate of 5 millitems individuals.
nre available for examination at the NRC per hour at 1 meter from a patient to a The NRC is adopting a new to CFR Public Document Room,21201. Street dose limit of 5 millislaverts (0.5 rem) 35.75(b) to require that the licensee NW. (Lower Levell Washington, DC. total effective dose equivalent to an provide released patients with individual from exposure to a released Instructions, including written VI. Discussion of Text of Final Rule patient. (The dose from the radionuclide instructions, on how to maintain doses i This section summarir.es the final involved is taken to be the dose to total to other individuals as low as is
?
rule. The NRC is amending 10 CFR decay.) A dose. based limit provides a reasonably achievable if the total 20.1301(al(1) to state specifically that single limit that can be used to pmvide effective dose equivalent to any the dose to individual members of the an equivalent level of protection from individual other than the released 4 public from a licensed operation does nsks from all radionuclides. Also, the patient is llLoly to exocod 1 millisievert i
5
. c. - . . ,_n-.n.., ---. ,n --r,--. n.-n. .,--n, , , , - -n -, --n-- -.
i 4110 rediral Ruht:r / Vol. 02, No.19 / Wednesday, January 29, 1997 / Rules and Regulations (0.1 rem). This also requires giving pxtient. For wornen who tre brr.est. of the nonstandard conservative instructions to a woman u ho is broart- feeding a child where the dose to the assumptions listed in 10 CFR 35.75(c),
feeding a child if the dose to the child child is likely to exceed 1 millislevert if other case-specific factors are used as i could exceed 1 millislevert (0.1 rem) (0.1 rem), the NRC requires that the the basis for patient telease that are in ansuming there were no interruption of patient be provided with specific addition to, or modify, the Standard breast feeding. The instructions must instructions, as described in to CFR include guidance on discontinuation or 35.75(b). There is no specific conservative assumptions, a record of the interruption perimi for breart- the basis for the release, including the requirement to maintain a record assumptions used for the calculadons, feeding and the consequences of falling ladicating that breast feeding status was must also be maintained.
to follow the recomrnendation. detennined prior to the release of the Reguletory Guide 8.39 contains tables This recordlceplug requirement is a /
patient.
that show temporary interrup lon modtlication of the proposed rule. The - '
The NRCis adopting a new to CFR '
periods for various 35.75(c) to require that the licensee proposed rule would have requi5d that-
_ radiopharmaceuticals or rnalntain a record of the basis for a record be maintained of the br. sis for discontinuatfon. The temporary authorir.ing the rtlease for 3 years if the the patient's release including all interruption periods were calculated calculations performed,if the total calculation of the total effectlve dose based on the determination that the equivalent to other individuals uses the effective dose equivalent to any dose to a child from breast feeding is retained activity rather than the activity individt..! othw d a.thneleased 4
~
unlikel to exceed 1 millisleve:1(n.1 administerod, an occupancy factor less f>atient rem). I owever, the physician rney use than 0.25 at 1 meter, the biological or 0.1 rem)inisalikely to exceed year from a single 1 millislevert discretion in the recommendation, effective half-life of the radionuclide.or administration. Under the oroPosed increasing or decreasing the duration of shieldin of radiation by the patient's k th' a)
$,'to provi
!O d I interruption somewhat depending on tissue. 'I ius, recorde of release are ie sfs forI mlIing the the woman's concerns about '
required when the defs slt assumptions dose to 5 millisleverts (0.5 rem) to radioactivity or interruption of breast. are not used as discussed in Reg.ulatory individuals exposed to a patient who feeding. may receive more than one Guide 8.39. Measurements made in The purpose of describing the several ritudies indicate that the default
' U consequences is so that women will assumptions should generally "dm1lld econ itfon
" "]ed b a public understand thet breast feeding after an overpredict the dose even when comments and consultation with the administration of certain radionuclides instructions are not given or are not could cause harm (e.g., lodine 131 could strictly followed. If a licensee ACMU1, and the NRC anVisitin NRCMedicamedical consultant' ,
Fellow harm the child's thyroid), in other cases, administers an activit no rester thau the NRC has decider to delete this the guidance could simply address the value in the defauft tab $e of 'tre release "
avoidance of an unnecessary radiatlon quantitles provided in the regulatory n P acti ealed no ommon posure to the hild from breast. ,
I as ti e bas o release, no record
['c g(*5m " *'
( 6 u)
A requirement for instructions for Licensees are already required b limit because of multiple certain patients was already contained CFR 35.53 to retain sticords of the, y to administrations in tbe same year to the in 10 CFR 35.315(a)(0) and 35.415(a)(5), measurement of the activity of each same patient. Without the need to but the modified requirement for dosage of radioactive material account for the dose from multiple written instructions adds approximately administered to a patient; theso records administrations, maintaining records for (a) 50,000 patients per year who are are typically maintained in a patient the many tens of thousands of patients administen,d lodine-131 for the dose log. In addition,10 CFR 35.32 seleased when their dose to an treatment of hyperthyroidism and (b) requires licensees to retain a written individualis likely to exceed 1 27,000 patients por year, among about 8 directive and a record of each millislevert (0.1 millislevest) becomes million administered admints'ered radiation dose or an unnecessary burden. The radiopharmaceuticals, who may be radiopharmaceutical dosage for requirement to retain these records has breast feeding to whom additional therapeutic administrations and therefore been deleted. Each patient written instructions be given. The diagnostic administrations of iodine 125 release is to be treated as a separate purpose of the written instructions in to or iodine-131 sodium iodide greater event, and licensee knowledge of maintain doses to individuals exposed than 30 microcuries. These records can previous administrations is to patients as low as is reasonably be used in con [ unction with Regulatory unnecessa.ty.
achievable. The instructions may be ' Guide 8.39 to demonstrate that patient The NRCis also adopting a new to either written only or written plus oral. releases meet the requirements of to CFR 35.75(d) to require that the lleensee The NRC believes that written CFR 35.75(a) when no secord is required maintain a record that instructions were !
lustructions are necessary so that the by to CFR 35.75(c). When the licensee provided to a woman who is breast.
patient and the patient's family and determines that the patient must be held feeding a child if the administared friends w'll have a document to refer to to allow the reduction of radioactivity activity could result in a total effective rather than having to rely solely on the and then released, the licensee will dose equivalent to the breast feeding patient's rnemory and understanding of need a record of release time to child exceeding 5 millisleverts (0.5 rem) the instructions, demonstrate that the release criteria if the woman did not interrupt or The requirement of to CFR 35.75(b), have been met. A licensee maf use any discontinue breast.foeding. Thus, the requiring a licensoc to provide guidance existing record to establish the release NRC is requiring records for certain on discontinuation or the interruption time. If biological elimination of radiopharmaceutical administrations period for breast. feeding and the radiolodine is a basis for release and the (e g.. therapeutic administrations of tunsequences of failing to follow the licensee uses the information in iodine 1311. The activities of recommendation, presumes that the Regulatory Guide 8.30, a record of the radiopharmaceuticale, that require this licent.co will mal wpropriate inquiry thyroid uptake may be necessary as part record are described in Regulatory regarding the breast..eeding status of the of the basis for release because it is one Guide 8.39.
- . - _ - _ __. - .=
l'ederal Register / Vol. 02, No.19 / Wrdnesday, Janu:ry 29, 1997 / Itul:s and Regul:tions 4131 Finally, the NRC is deleting its airborne emiulons from uranium fuel statement of the policy reads "The NRC requirements on uritten instructions in cycle facilities. Part 190 of Title 40 of will continue to regulate the medical to CFR 35.315(a)(6) and 35.415(a)(5) the Code of Federal Regulations does uses of radioisotopes as nocessary to because those paragraphs are redundant not apply to hospitals or to the relene provide for the reflation safety of now that 10 CFR 35.75 has requirements c! patients. workers and the general public." The for instructions. In addition,10 CFR furtherrare,10 CFR 20.1301(d) does rule is consistent with this statement 35.415(a) and (a)(1) are mworded to not incorporate the ITA's Clean Air Act Inause its purpose is to provide for the '
clarify the odginalintent of the standards in 40 CFR part 01 that applies ufety ofindividual memoers of the paragraphs, which was to limit the dose to hospitals.The NRC is separately public exposed to patients administere3 rate at 1 meter from the patient. The pursuing actions with the FPA to radioactive materials.
amblEulty was introduced when part 20 minimite the impact of dual regulation The second statement of the policy is was revised and a conforming change under the Clean Alr Act and to take "The NRC will regulate the redlation was made in 10 CFR 35.415. The agreed upon actions that willlead to safety of patients where justified by the conforming change that was made was FPA racision of 40 CFR part 01 for NRC risk to patients and where voluntary not fully consistent with the original and Agreement State licensees. Because standards, or compliance with these intended meaning of 10 (JR 43.4 sola) the reference to FPA m ulations in 10 standards, are inadequate /' This and (a)(1) CFR 20.1301(d) has not ing to do with statement is not relevant to the rule the patient release issue, and therefore because the rule does not affect the -
Vll. Die ition of the petitions for safety of patients themselves. The rtde is t.utside the scope of this rulemaking, Rulema ing the final rule dentes this request. Instead affects the safety of individtals The three etitions for rulemaking The mquests made by the ACNM and exoosed to patients.
submitted b Dr. Marcus (PRM-20-20), their disposition may be summartred as The third statemeut of the policy the ACNM ( 'RM-35-10 and PRM follows: . reads "The NRC will minimize .
10A), and the AMA (PRM-35-11) (1) Adopt a doselimit of 5 intrusion into medical judgments requested that the NRC amend the millisleverts (0.5 rem) for indMduals affecting patients and into other areas _
revised 10 CFR part 20 and to CFR part exposed to patients who have been traditionally considered to be a part of
- 35. These requests and their disposition administemd radiopharmaceuticals. The the practice of medicine." The rule is by this ruleraaking are discussed below, final rule grants this request. consistent with this statement because it The requests made by Dr. Marcus and (2) Permit llaensees to authorize places no requirements on the their disposition may be summarized as release from hospitalization any patient administration of radioactive materials follows: administered a redlopharmaceutical to patients and because the release of (1) Raise the radiation dose limit in 10 regardless of the activity in the patient patients administered radioactive CFR 20.1301(a) for individuals exposed by defining " confinement" to include materials has long been mnsidered a to radiation from patients receiving not only confinement in a hospital, but matter of regulatory concem to protect redlopharmaceuticals for diagnosis or also confinement in a private residence. members of the public rather than solely therapy from 1 millislevert (0.1 rem) to The final rule denies this mquest for the a matter of medical judgment.
5 millisleverts (0.5 reml. The final rule reasons described in the discursion on Thus, the final rule is considered to >
grants this request. this issue. be consistent with the 1979 Medical (21 Amend 10 CFR 35.75(a)(2) to Finally, the requests made by the policy Statement.
retain the 1.110-megabecquerel (30- AMA did not all ertain to the issue of IX, issue of Compatibility for millicurie) limit for lodine 431, but patient release. T e final rule grants the provide an activity limit far other request pertaining to patient release,i.e., ^8"'"'"I S"
radionuclides consistent with the that the radiation dose limits nn to CFR The NRC considers the definitions calculational methodology employed in 20.1301 should not apply to individuals contained in 6 20.1003 and the text in '
the National Council on Radiation exposed to the patient and that the dose $ 20.1301(a) that are modified by this Protection and Measurements (NCRP) limit to the individuals should be 5 rulemaking are Division 1 levels of Report No. 37," Precautions in the millisteverts (0.5 rem). The reguest to compatibillt , The definitions and text Management of patients Who llave change the tenn "hospitallred
- in 10 in these sect ons must be the same for CFR 35.310(a) and 35.315(a) to the term all NRC and Agreement State licensees Received Therap* utic Amounts of so that national consistency can be Radionuclides.' The final rule does " confined" was denied for the reasons not contain activity limits, but discussed above. The request not related maintained.
Regulatory Guide 8.39 uses a to the sub}oct of patient release (that it Section 20.1002," Scope."is a calculational methodology based on should be clear la Part 20 that Part 20 Division a level of compatibility NCRP Report No. 37 to relate the dose < loos not limit the intentional exposum because this section by nature is not a to the quantity of activity in the patient, of patients to radiation for the purpose regulatory requirement and many States Therefore, the wish of the petitiot.or to of medical diagnosis or therapy) was are prohibited by their administrative d have an easy method to determine wlen addressed in another rulemaking, procedures act from including such the patient may be relea. -1 is granted in " Medical Administration of Radiation sections in their rules. The scope Regulatory Guide 8.39. and Radioactive Materials," which was section is a general statement of scope (3) Delete to CFR 20.1301(d), which published as a final rule on September of the rule and does not contain specific requires licensees to comply with 20,1995 (60 FR 48623), and became requirements thet are not presented in provisions of the F.nvironmental effective on October 20,1995. other sections of part 20. Rules at the Protection Agency's environmental Division 3 level would be appropriate Vill, Consistency With 1979 Medical for Agreement States to adopt,but they regulations in 40 CFR part 190 in aridition to complying with the Policy Statement do not require any degree of uniformity requirements of to CFR part 20.The On February 9,1979 (44 FR 8242), the between NRC and State rules.
EPA regulations referenced in 10 CFR NRC published a Statement of General Additionally, $$ 35.75(a) and (b) are a 20.1301(d) are contained in 40 CFR part Policy on the Regulation of the Medical Division 2 level of compatibility 190, which deals only with doses and tfses of Radioisotopes The first because the patient release enteria i
4132 k federtl Regliter / Vol. 02, No.10 / Wednesday, January 20, 1997 / Rules and Regul:tions tequired by the rule are the minimum The public reporting burden for tMs requirements noccuary to ensure 1.ists of Subletts colketion ofinfonnation is estimated 56 adequate protec tion of the public health average 13 hours1.50463e-4 days <br />0.00361 hours <br />2.149471e-5 weeks <br />4.9465e-6 months <br /> per licensee per year, to N M to and safety. The Agreement States will including the time for reviewing be allowed to establish requirements flyproduct material, Criminst instructions, scarthing existing data penalties. Licensed ms.terial NuclJar that are more stringent than the NRC's sources, gathering and maintaining the materials. Nuclear power plants and requirements, but not less stringent. The data needed, and completing and reactors. Occupational safety and i reviewing the collection of information. health. Packaging and containers, recordiceping req)uirements in$$ 35.75(c) and (d are aRadiation Division 3 level Send protection. Reporting and comments !o of cornpatibility because unifonnity in collection of infonnation, including !
recordkeeping is not considered recordkeeping re suggestions for reducing the burden, to nuclear materialqstrements Special Source material, Waste essential for this rule. the information and Recorde treatment and disposal.
X Small Businema Regulatory Management Branch (T-6 F33), U.S.
Enforcement Fairness Act Nuclear Regulatory Commission, gg
- in accordance with the Small Washington, DC 20$$$-0001, or by Dy Business Regulatory Enforcement Internet electronic mall at enefiroduct ties.Dru s llmaterial Criminal '
Fairness Act of 1990, the NRC han D)S10NRC.COV; and to the Desk l>lealth professko,ne,ealtllacilities, Officer, Office of information and Incorporation by determined that this action is not a reference Medicaldevices, Nuclear major rule and has verthed this Reguistory Affairs, NEOD-10202, (3150-0010), Office of Management and health, and determination with the Office of Dudget Washington, DC 20503.
materials, Occupational Radiation protection, safetkeporting In motion and Regulatory Affairs of and recordkeeping requirements.
Public Protection Notincation For the reasons set out in the XI. Finding ofNo Significang The NRC may not conduct or sponsor' preamble and under the authority of the EnvironmentalImpact Availability and a e a s not teq o s n Atomic Energy Act of 1954, as amended;
,,. 9g 9g the Energy Reorganir.ation Act of 1974, The NRC has determined under the as amended; and 5 U.S.C. 552 and 5531 National Environmental Policy Act of displays a currently valid OMB control 1900, as amended, and the number
- the NRCis adopting the following amendments to 10 CFR parts 20 and 35.
Conunission's regulatirms in subpart A Xill. Regulatory Analysis of to CFR part St. that the amendments The NRC has repared a final tre not a major Federal action regulatory anal PROTECTION AGAINST RADIATION significantly affecting the quality of the (NUREG-1492) on this regulation. e analysis examines human environment, and therefore an 1.The at.thority citation for part 20 )
the benefits and impacts considered by anvironmentalimpact statement is not the NRC. The NRC has received public continues to scad as follows:
required. The final amendments clarify 8 the portinent regulatory language to comments regarding the draft regulatory d"y'ily8]'g,3 M analysis and has addressed the ,1 Q 1[
refloct explicitly the relationship comments (see Comments on the Draft 937. 948, en 955. as amended. ac.1701, between 10 CFR part 20 and part 35 Regulatory Analysis in Section 111. 106 Stat. 2951,2952,2953 (42 LLS.C. 2073, With respect to release of patients, and 2093.2005.2111,2133.2134,2201,2232 Public Comments on the Proposed 2236. 22970, acs. 201, as amended. 202 '
the amendments I$ vise the release Rule). The final regulatory analysis is 200 as Stat.1242.as amended.1244,1240 critetta for patients receiving radioactive available forinspection at the NRC (42 U.S.C. satt. 5a4 2. 6846).
material for medical use from an Public Document Room at 2120 L Street totivity based standard to a dose basis. NW. (bower Level), Washington. DC, 2. S. ection 20.1002 is revised to read
,, go,3g,,*.
It is expected that there will be Single copies are available as indicated relatively little change in radiation dose in the ADDRESSES heading. $ 20.1002 Scope.
to the public or to the environment as XIV. Regulatory Flealbility Certification The regulations in this part apply to Yoina n nr eNa assebment As utred by the Regulato persons licensed by the Commission to i and finding of no significant impact on Flexilhty Act of 1080. 5 U.SE 605(b),receive, Possess, use, transfer, or which this determination is based is the NRC certifies that this rule will not dispose of byproduct, source, or special available for inspection at the NRC have a significant economic impact on nuclea: mater!al or to operate a Public Document Room. 2120 L Street a substantial number of small entitles. production or utillr.ation facility under NW. (Lower Level), Washington. DC. This rule affects medical use of parts 30 through 35,39,40.50.00,61 Single copies of the environmental byproduct material licensees. The 70 or 72 of this cha ter. The limits in ofno impact of the final rule will not be this part do not op y to doses due to spessment and the significant impact are avai findin$able as significant because the final rule background radiat on, to exposure of indicated in the FOR FURTHER basically represents a continuation of patients to radiation for the purpose of INFORMATION CONTACT heading. Current practice. ao dj,c4 9 d)ag9 g er,apf
,, tg XII. Paperwork Reduction Act XV.Itackfit Analysis Statement raficactive material and released in The NRC has determined that the accordance with $ 35.75, or to exposure This final rule amends infonnation backfit rule, to CFR 50.109 does not from voluntary participation in medical }
collection requirements that are subject apply to this rule, and therefore, that a research programs.
to the Paperwork Reduction Act of 1095 backfit analysis is not required for this 3. In $ 20.1003. the footnote to tho (44 U.S.C. 3501 et seq.). These rule, because these amendments do not (
definition of member of the public is requirements were approved by the involve any provisions that impose removed and the definitions of -
Office of Management and Budget, j backfits as defined in to CFR occupational dose and pablic dose are approval number 3150-0010, 50.109(a)(1).
i revised to read as follows:
., e.
Federal Reglat:r / Vol. 02 No.19 / Wednisday,1:nuary 29,1997 / Rules and Regul:tions 4133 l l
iM.1003 Defmit6ons. . , .
( 20.1903 Escept6one to postin9 exceed 1 millislevert (0.1 rem) assuming
- s e o e mtukements, there were no interruption of breast.
feeding, the instructions shall also Occupadonal dose muns the dose received by an individual in the cowse (b) Rooms of other areas in hospitals include:
of employmen,in which the that are occupied by patients are not (1) Guidance on the Interruption or individual's wigned duties involve required to be posted with caution si ns discontinuation of breast feeding and exposure to radiation or to radioactive pursuant to $ 20.1902 provided that the patient could be released from licanace (2)information on the consequences material from licensed and unlicensed of failure to follow the guidance, sources of radiation, whether in the control pursuant to $ 35.75 of thl:
posseulon of the licensee or other chapter. (c)Thelicensee shall maintain a person. Occupational dose does not * * * *
- record of the basis for authorir.ing the include dose received from background PART 3640EDIC/,t.USE OF
I** " f "" d""I' I # 8 I'" '
radiation,itom any medical the date of release,1f the totaleffective administration the individual has BYPRODUCT MATERIAL dose equivalentis calculated by received, from exposure to individuale
. 6.The authority citation for part 35 (1) Using the retained acdvity rather administered radloactive snaterial and continues to read as follows: than the activity administered, relear,ed in accordance with $ 35.75, from voluntary participation in medical Authority: Secs. 8 t, tal.182, t us. r,6 Stat- (2)Using an occupancy factorleu i ss. 94a. ess,954, as amended (es (f.s.c than 0.25 at 1 meter' research programs, or as a member of 1tti,2 on,22:2, rassh eec. not,saamst.
the public. !!42, as amended 14I U.S.C 5841). (3) Using the biological or effective hah.ufe, or Pubfle do,e means the done received 7, in $ 35.8, paragraph (b) is tevised ta el ?* follows: (4)Considering the shielding by by a member of the public from duue, exposure to radieuon or radioactive gg,,,,,,,,,,,,,,,,,,,,,,,, (d)The bcensee shall maintain a material released b a licensee, or to any requiremonte: OMS approval.
other source of rad ation under the e e . . e record, for 3 years after the date of release, that instructions were provided (b) The approved irformation o nelude bona eo rs collection requirements contained in to a breast feeding woman if the received from ba kground radiation this part appear in $$ 35.0,35.12,35.13, radiatton don to t1 e infant or child from any medical administration thf 35.14,35.20,35.21,35.22,35.23,35.29, from continued br.at feeding could individual has received, from exposure 35.13,35.50,35.51,35.52,35.53,35.59, result in a total effective dose equivalent to individuals administered radioactive 35.00,35.61,35.70,35.75,35.80,35.92, exceeding 5 millisleverts (0.5 rem).
material and released in accordance 35.204,35.205,35.310,35.315,35.404, with $ 35.75, or from voluntary 35.400,35.410,35.415,35.606,35.610, ty.315 (Amended) 4e, participation in medical research 35.615,35.030,35.632,35.634,35.636, 9. In 6 35.315, paragraph (a)(6)is prograrns. 35.641,35.643,35.645,35.647,35.980 removed and reserved, and 35.981, t agra h(a)is h to da 8. Section 35.75 is revised to read as (a) * *
- 4 30.1301 Done limite for individual follows: (6)(Reserved) members of the putdic. . .
i 36.75 nelease ofIndividuals containing . . .
(a) Each licensee shall conduct oph f"P3*",armaceuticola or permanent 10. In f 35.415, the introducto#Y text op(erations so that-1) The total effective dose equivalent -
to paragra (a)and aragraph(a)(1)are (a) The licenseo may autharir.e the to individual members of the public revised an paragrep (a)(5)is removed.
from the lice.aed operation does not release from its controlof any exceed 0.1 rom (1 millislevert)in a year, individual who has been administered $ 38.415 Safety preeeu' ions.
exclusive of the dose contributions from radiopharmaceuticata or permanent background radiation, from any medical implanta containing radioactive material (a) For each patient or human if the total- octive done equivalent to ,,,, .ch subject receiving implant administration the individual has 'idual from exposure to received, from exposure to individuals any othe. therop and not released from licensee the *eleased individual is not 'ilely to enntrof pur.uant to l 35.75 of this part, administered rar'.ioactive tanterial and released in accordance with 6 35.75, exued 5 millisleverts (0.5 rem).8 a licensee shau*-
(b) The licensee shall provide the from voluntary participation in medical released individual with instructions, (1) Not quarter the patient or the research programs, and from the human research subject in the same licensco's disposal of radioactive including written instructions, on materialinto sanitary sewerage in actions recommended to maintain dosos room as an individual who is not to other individuals as low as is receiving radiation therapy.
accordance with 6 20.2003, and .
(2)The dose in any unrestricted area reasonably achievable if the total . . . .
from external sources, exclusive of the e(foctive dose equivalent to any othr
- Dated at Rockville. Md.. this tard day of dose contributions from patients individualis likely to exceed 1 january,1997.
adn inistered radioactive material and millislevert (0.1 rem). If the dose to a For the Nuclear Regulatory Commissloo.
released in accordance with ( 35.75, breast feeding infant or child could lehn t Hope, does not exceed 0.002 tem (9.02 Secretary of the commission.
raillislevert1in any one hour. 'Resulaiory cuid, a se, an.t of rati nu Administ.r.d R.dioactive Materials." descrities (FR Doc. 97-2t06 Filed 1 26-97; a.45 aml
' as d d d uuwe cooe naam
- 5. In 5 20.1903, paragraph (b) is Ni.In.*i.$f.','lr c,f,.aiiagy ,,, ye,*,'N revised to read as follows: do. eiceedins a mitiisi.verts (o s e.mi.
1 k
.. "The Honorable Lauch Faircloth, Chairman C Subcommittee on Clean Air, Wetlands, Private Property and Nuclear Safety
~ A&.h l c1 Committee on Environment and Public Works United Statea Senate Washington, DC 20510
Dear Congressman Faircloth:
Enclosed for the information of the Subcommittee are copies of a public announcement and a final amendment to 10 CFR Parts 20 and 35 dealing with criteria for the release of patients administered radioactive materials.
Roughly 8 to 9 million medical diagnostic and therapeutic administrations of radioactive material are performed in the United. (tates each year.
The rule is largely in response to three petitions for rulemaking that were submitted by the medical community because of concerns that the NRC's recent amendments of its regulations in Part 20, " Standards for Protection Against Radiation," would require medically unnecessary hospitalization of patients administered radioactive materials for the treatment of disease and would thus
.acrease national health care costs.
The rule makes it clear that the release of patients administered radioactive materials continues to be regulated by the requirements in NRC's Part 35,
" Medical Use of Byproduct Material." Thus, the more restrictive requirements in Part 20 do not apply to release of patients. While the comments of the medical community on the proposed rule were generally supportive, they objected strongly to one of the recordkeeping requirements contained in the proposed rule. Upon reconsideration, the NRC has deleted the recordkeeping requirement in question after concluding that the records were not necessary to provide for adequate protection of public health and safety.
Sincerely, Dennis K. Rathi>un, Director Office of Congressional Affairs
- 1. Public Announcement
- 2. Federal Register Notice cc: Senator Bob Graham Dit tribution: G:\SCHNEID\ RELEASE \CL.FRM
[gttier/RPHEBrf File Center NCostanzi
- See previous conc. C ,
f Office RPHEB:DRA RPHEB:DRA D:DRA:RES .EdE$'
Name SSchnoider* CTrottier* BMorris* Difort1 son Date 1/17/97 1/17/97 1/17/97 1/ 9 / /97 oistributt a Yes/No Yes/No Yes/No Yes/No Office OGC Name DRathbun Date 1/ /97 Distribution Yes/No 0FFICIAL RICORD COPY (File Code No.)3A-3
F
.The Honorable Dan Schaefer, Chairman Subcommittee on Energy and Porer Committee on Commerce ]P , , gj ) y "'
United States House of Representatives Washington, DC 20515
Dear Congressman Schaefer:
Enclosed for the information of the Subcommittee are copies of a public announcement and a final amendment to 10 CFR Parts 20 and 35 dealing with criteria for the release of patients administered radioactive materials.
Roughly 8 to 9 million medical diagnostic and therapeutic administrations of radioactive material are performed in the United States each year.
The rule is largely in response to three petitions for rulemaking that were submitted by the medical community because of concerns that the NRC's recent amendments of its regulations in Part 20. " Standards for Protection Against Radiation," would require medically unnecessary hospitalization of patients administered radioactive materials for the treatment of disease and would thus increase national health care costs.
The rule makes it clear that the release of patients administered radioactive materials continues to be regulated by the requirements in NRC's Part 35,
" Medical Use of Byproduct Material." Thus, the more restrictive requirements in Part 20 do not apply to release of patients. While the comments of the medical community on the proposed rule were general'ly supportive, they objected strongly to one of the recordkeeping requirements contained in the proposed rule. Upon reconsideration, the NRC has deleted the recordkeeping requirement in question after concluding that the records were not necessary to provide for adequate protection of public health and safety.
Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosures:
- 1. Public Announcement
- 2. Federal Register Notice cc: Rep. Frank Pallone Distribution: G:\SCHNEID\ RELEASE \CL.FRM CTrottier/RPHEB rf File Center NCostanzi
- See previous conc.
Office RPHEB:DRA RPHEB:DRA D:DRA:RES -
-D:RESk I Name SSchneider* CTrottier* BMorris* / bMofKs$n Date 1/17/97 1/17/97 1/17/97 1/ 2. /97 otstributim Yes/No Yes/No Yes/No Yes/No Office OGC Name DRathbun Date 1/ /97 Distributi m Yes/No 0FFICIAL RECORD COPY (file Code No.)3A-3
i Nk r g G -&l- W ,
The Honorable Newt Gingrich '
Speaker of the United States
. House of Representatives Washington, DC 20515 l
Dear Mr. Speaker:
Pursuant to Subtitle E of the Small Business Regulatory Enforcement fairness :
Act of 1996, 5 U.S.C. 801, the Nuclear Regulatory Commission (NRC) is -
submitting a final rule that amends the Comissions's regulations.concerning '
the criteria for the release of patients administered radioactive material.
The new criteria for patient release are based on the otential dose to other individuals exposed to the patient. The rule is large y in response to three petitions for rulemaking that were submitted by the medical comunity because of concerns that the NRC's recent amendments of its regulations in Part 20, ,
" Standards for Protection Against Radiation," would require medically I unnecessary hospitalization of patients administered radioactive materials for the treatment of disease and would thus increase national health care costs.
The-new criteria are consistent with the recomendations of the National Council on Radiation Protection and Measurements and the International Comission on Radiological Protection. '
We have determined that this rule is not a " major rule" as defined in 5 U.S.C.
804(2). We have confirmed this determination with the Office of Management :
and Budget.
-Enclosed is a copy of the final rule that is being transmitted to the Offi,:o of the Federal Register for publication. The Regulatory Flexibility Certification is included in the final rule. Also~ enclosed are copies of the Regulatory Analysis and the Environmental Assessment for this rule. This i final rule is scheduled to become effective 120 days after publication in the Federal Reaister, ,
Sincerely, Dennis K. Rathbun, Director f
Enclosures:
Final Rule Regulatory Analysis Environmental Assessment DOCUMENT NAME: G:\SCHNEID\ RELEASE \ LETTERS.FRM ,
5.. .. ..... .m .. w c .c .- tL D N N I$c.c , .m ,- ~ . v .u.. , ,
OFFICE RPHEB/ORAv RPHEB/DRA _.
.ppC o QMhb l ,
D/REf D/OCA NAME SScbbelder k kf CTrottierN (vh0$rEstead horris QMokrison DRathbun DATE k/[97 If /97 1/))97 l C/97 !
l / '/97 /197 0FFICIAL RECORD COPi
-i
)
i PDL
, f)6-4l' b The lionorable Al Gore President of the United States Senate Washington, DC 20510
Dear Mr. President:
Pursuant to Subtitle E of the Small Business Regulatory Enforcement fairness Act of 1996, 5 U.S.C. 801, the Nuclear Regulatory Commission (NRC) is submitting a final rule that amends the Commissions's regulations concerning the criteria for the release of patients administered radioactive material.
The new criteria for patient release are based on the potential dose to other individuals exposed to the patient. The rule is largely in response to three petitions for rulemaking that were submitted by the medical community because of concerns that the NRC's recent amendments of its regulations in Part 20,
" Standards for Protection Against Radiation," would require medically unnecessary hospitalization of patients administered radioactive materials-for the treatment of disease and would thus increase national health care costs.
The new criteria are consistent with the recommendations of the National Council on Radiation Protection and Measurements and the International Commission on Radiological Protection.
We have determined that this rule is not a " major rule" as Jefined in 5 U.S.C.
804(2). We have confirmed this determination with the Office of Management and Budget.
Enclosed is a copy of the final rule that is being transmitted to the Office of the Federal Register for publication. The Regulatory Flexibility Certification is included in the final rule. Also enclosed are copies of the Regulatory Analysis and the Environmental Assessment fe" this rule. This final rule is scheduled to become effective 120 days after publication in the Federal Reaister.
Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosures:
Final Rule Regulatory Analysis Environmental Assessment DOCUMENT NAME: G:\SCHNE!D\ RELEASE \ LETTERS.FRM
...._... ..,_ _ . _ . ..... _ f.h t4 &,
OFFICE RPHEB/DRA i ,. RPHEB/DRA OGC p)Qk e
-D/RES D/OCA i NAME SSchneider hf CTrottier Oh, Nmskesd horris -DMoriis~on DRathbun DATE \)(97 i O/97 l /)/97 /(l/37 g //97 / /97 0FFICIisL RECURD~~ CDP (
h -
() 6 L)l- >
Hr. Robert P. Murphy General Counsel General Ar. count ing Office Room 7175 441 G. St., NW Washington, DC 20548
Dear Mr. Murphy:
Pursuant to Subtitle E of tha dall Business Regulatory Enforcement Fairness Act of 1996, 5 U.S.C. 801, the Nuclear Regulatory Commission (NRC) is submitting a final rule that amends the Commissions's regulations concerning the criteria for the release of patients administered radioactive material.
The new criteria for patient release are based on the potential dor,e to other individuals exposed to the patient. The rule is largely in response to three petitions for rulemaking that were submitted by the medical community because of concerns that the NRC's recent amendments of its regulations in Part 20,
" Standards for Protection Against Radiation," would require medically unnecessary hospitalization of patients administered radioactive materials for
-the treatment of disease and would thus increase national health care costs.
The new criteria are consistent with the recommendations of the National Council on Radiation Protection and Measurements and the International i Commission on Radiological Protection.
We have determined that this rule is not a " major rule" as defined in 5 U.S.C. ;
804(2). We have confirmed this determination with the Office of Management and Budget.
Enclosed is a copy of the final rule that is being transmitted to the Office of the Federal Register for publication. The Regulatory Flexibility Certification is included in the final rule. Also enclosed are copies of the Regulator / Analysis and the Environmental Assessment for this rule. This final rule is scheduled to become effective 120 days after publication in the Federal Reaistt;r,.
Sincerely, Dennis K. Rathbun, Director
Enclosures:
Final Rule Regulatory Analysis Environmental Assessment DOCUMENT NAME: G:\SCHNEID\ RELEASE \ LETTERS.FRM p t.. . ... -.~...m. c .c... .o d .k b r . c r, . .n ~ . Z .u u. .
OFFICE RPHED/DRA RPHt:D/DRA .pGq , C/ 'JMES D/OCA NAME SSchneid CTrottier O Q Imskead horris b -DM66Ison DRathbun DATE \/h7 I/ 39 7 i/A97 j li//97 I//97 //97 OffTCTAURECDRD~IDW
pa%
q* 4 UNITED STATES j
s* NUCLEAR REGULATORY COMMISSION
, c wAsmwovow, o.c. mssaos
% ..... / .
AE-41-2 August 7,1997 MEMORANDUM TO: Don Lanham, DCB, DISS, ADM FROM: Stewart Schneider, DRA, R(
SUlUECT: REGULATORY lilSTORY FOR CIUTERIA FOR THE RELEASE OF INDIVIDUALS ADMINISTERED RADIOACTIVE MATERIALS (10 CFR PARTS 20 AND 35)
(62FR4120, 01/29/97); FINAL RULE -- RIN 3150-AE41 Attached for your processing are regulatory documents considered to be of central relevance to the final rulemaking entitled " Criteria for the Release of Individuals Administered Radioactive Materials" (10 CFR Farts 20 and 35). Also attached is an index of these documents. The designator assigned by the Rules Review and Directives Branch is AE41-2 and is noted in the upper right hand corner of the cover page for each document.
Attachments:
- 1. Index
- 2. Documents cc w/att 1: Betty Golden, RRDB/ADM
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