ML20135D949
| ML20135D949 | |
| Person / Time | |
|---|---|
| Issue date: | 12/04/1996 |
| From: | Jackson J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | Shirley Ann Jackson, Rogers K, The Chairman NRC COMMISSION (OCM) |
| References | |
| DSI-12-00036, DSI-12-36, NACMUI, NUDOCS 9612100279 | |
| Download: ML20135D949 (1) | |
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UNITED STATES g,
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NUCLEAR REGULATORY COMMISSION 3(o t
WASHINGTON, D.C. 20555 4001 December 4, 1996 4
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g R&D MEMORANDUM TO:
Chairman Jackson
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Commissioner Rogers Commissioner Dieus g
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Commissioner McGaffigan 01110004 the c,'
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James M. Taylor b
Executive Direc r fo Operations
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SUBJECT:
ADVISORY COMMI EE ON THE MEDICAL USES OF ISOTOPES COMMENTS ON DIRECTION SETTING ISSUE i
l PAPERS Attached are the Advisory Committee on the Medical Uses of l
Isotopes (ACMUI) comments on the Strategic Assessment (SA) and Direction Setting Issues (DSI) papers, from their meeting held on
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l November 14-15, 1996.
Major topics of discussion were SA and DSI papers number 7,
" Materials / Medical Oversight" and number 12,
" Risk-Informed, Performance-Based Regulation."
Detailed minutes
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of the entire meeting will be forwarded later.
Attachment:
ACMUI Comments i
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CONTACT:
Torre Taylor, NMSS (301) 415-7900 l
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I 9612100279 961204 PDR NRCSA I 12 PDR DS/3
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- t UNITED STATES
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j NUCLEAR REGULATORY COMMISSION 2
WASHINGTON, D.C. 20555 0001
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November 26, 1996 MEMDRANDUM T0:
Donald A. Cool. Director Division of Industrial and Medical Nuclear Safety, NMSS FROM:
Judith Anne Stitt. M.D.. Chairm4rf)
AdvisoryCommitteeontheMedicay Uses of Isotopes
SUBJECT:
COMMENTS ON STRATEGIC ASSESSMENT AND DIRECTION SETTING ISSUES PAPERS I am providing the ACMUI's comments on the Strategic Assessment (SA) and discussion of the Direction Setting Issues (DSI) papers for submission to the Commission prior to the end of the comment period on December 2. 1996.
Detailed minutes of the entire meeting will be forwarded at a later date. The Advisory Committee on the Medical Uses of Isotopes (ACMUI) met on Nove.rber 14-15, 1996. Strategic Assessment and discussion of the DSI papers were a major topic of discussion during the meeting.
The ACMUI deliberated on a number of thoughts and ideas on the SA process, many of which will be detailed in the minutes.
I am summarizing the main issues and the consensus items as a result of the committee's discussions.
The ACMUI had extreme difficulty in understanding DSI #12. Risk-Informed.
Performance-Based Regulation. The paper is difficult to comprehend and members were concerned that members of the public would have difficulty understanding the issues, thereby minimizing the number of comments the Commission might receive on the risk paper.
The ACMUI agrees that risk should be used as a factor in establishing regulations. Members expressed concern as to who will determine risk in using a risk assessment approach to the development of regulations. Additionally.
in discussing risk, it is unclear if it is risk in terms of occupational worker risk or public safety risk, and how this relates to considering a patient as a member of the public, as discussed in the 1979 Medical Policy Statement. Assessment of medical risk versus benefit is the practice of medicine, rather than a regulatory decision.
The ACMUI discussed the options outlined in DSI #7, " Material / Medical Oversight." and were concerned that it appeared that ACMUI's recommendations resulting front its February 21-22. 1996 meeting were not considered by the Commission. The members indicated that they do not have the confidence, and they do not believe the regulated community has the confidence, that the NRC.
even with SA, can make the necessary changes to effectively regulate the use l
of byproduct material in medicine. The Quality Management rule was cited as l
an example, in that a performance-based rule has become very prescriptive.
After deliberation, the committee voted, by consensus, that the I
recommendations made during the February 1996 meeting are still the ACMUI's first choices for the direction in which the NRC should proceed. However, the i
l up l
l-i ACMUI Comments 2
ACMUI did agree to amend the initial recommendation that the Departm.ent of Health and Human Services should be the Federal agency for regulatory oversight, to state that a new or existing Federal agency for oversight needs to be an agency with a medical or health focus rather than a regulatory focus.
These recommendations are included in Attachment 1.
l However, given that these recommendations were not included within the i
preliminary views of the Commissioners. the ACMUI focused on the options given in DSI #7, especially low-risk versus high-risk activities. Time did not permit the ACMUI to develop a clear consensus as to what would constitute low-or high-risk activities.
As part of its discussion of DSI #7. the ACMUI focused on the 1979 Medical Policy Statement (MPS) (44 FR 8242) (Attachment 2).
There was considerable deliberation that when the Commission adopted the policy that medical patients are considered a member of the public. NRC began to interfere with medical practice. There is a conflict when the policy says that NRC will not practice medicine, but patients are considered a member of the public.
Statement 2 of the MPS states that "The NRC will regulate the radiation safety of patients where justified by the risk to patients and where voluntary standards, or compliance with these standards, are inadequate.
Many members indicated that.
based on this statement. there are many regulations for which the justification based on risk does not exist. such as misadministration 3 of diagnostic uses arj the requirement for ALARA. While the events that prompted the MPS had to be e&.ressed, there was some discussion as to whether NRC has gone beyond the bounds of the MPS by broadening its scope to include regulation that was not based sufficiently on risk.
The ACMUI discussed the need to revise the MPS. such as including the term i
"high" risk in Statement 2 of the MPS.
There was much controversy over this, and how to define "high" and whether this is the direction to go.
One has ts consider the benefit to the patient in addition to any risk to the patient.
There was discussion that the public needs to be better informed as to the risks of radiation.
Subsequently. the ACMUI made the following motion:
"The ACMUI recommends that NRC revise its Medical Policy Statement to include in statement number two the word "high" before " risk." St-ment #2 would then read:
The NRC will regulate the radiation safety of patients where justified by the high risk to patients and where voluntary standards, or compliance with these standards.
are inadequate.
This wcs approved by a vote of 6 in favor to 3 opposed.
One individual voting against the motion believed it was more important to indicate exclusion of low risks as regulation of high ';k activities is a given.
One individual believes that rev4 sing the s w tement to include "high" is an over simplification of the problem.
It is not differentiating the risk associated with things that take place as a part of the procedure separately from the medical procedure itself. One individual did not like using the term "high" in the statement.
l 1
ACMUI Comments 3
The ACMUI made the following amendment to the motion:
"The ACMUI believes i
that the 1979 Medical Policy Statement should be reconsidered; and the scientific basis of the statement needs to be reviewed witn consideration of current research and studies; and the ACMUI is committed to working with the i
staff and Commissioners to provide guidelines for determination of procedures and activities that range from low risk to high risk to patients. Therefore, j
the ACMUI recommends that the 1979 Medical Policy Statement be revised. This i
was approved by a vote of 6 in favor to 3 opposed. Again, those opposed believed that classifying activities by hig1 risk is an oversimplification of the problem. One individual voted against the amendment due to procedural reasons. He believed the original mcon should have been withdrawn: that the l
l amendment was a way to make the motion on the floor " fit" the current l
discussion.
Attachments:
1, ACMUI Recommendations 2/21-22/96 I
2.
1979 MPS j
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RECOMMENDATIONS OF ACMUI The ACMUI reached a consensus as a result of committee deliberations concerning the following actions that should be part of regulatory reform:
- Rebuild the medical use regulatory program, without using the current regulatory program as a starting point. The objectives of the regulations must be reassessed:
Federally mandate that the states administer the medical regulatory use program, with appropriate incentives to encourage states to comply:
. State programs should be monitored by a Federal agency. The Federal agency should be an agency with an overall medical use perspective.
. Encompass all uses of ionizing radiation in medicine, not just byproduct material and not just radioactive material); and
. Conduct the medical use regulatory program in a uniform setting, whether it is conducted by a Federal agency or by the states.
l ATTACHMENT 1
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I 0242 RULIS AND REGULATIONS g73gg)
- 1. Starneurr or Octrrus. Pouer generally criented tow ard axs:st:. g cualtfled phystelans in discharg.r.g I'#
'3 te ed to o
licerLsees, ther nu, ngulation by AE NRC N a.'
Tederal aM State agencies and the CHAPTER l-NUCLEAR REGULATORY one time or another eneempasse:
pub!!c of the Commission's genera! In.
COMMi$$lON tention regarding the terufstion of nearly ony asxet of the enm of the medical uses of radioisotopes, radiotsotope medical servlees to es-4 PART 10-HUMAN USE5 OF It is expected that future N'RC activ. tients. The broadest terulat:en oe.
C" BYPRODUCT MATERIALS les e
dleal a a such p
he and rug n r'o velopment of cooperative relationships (FDA) exempted from its rec.are.
Reguletten of the Medicel Uses of sith other Feders.1 agencies. will ments for new drugs au ted;eisstepes; Statement ef Ge'e'*
follow this state.nent of NRC policy.
radlophumaceutica!s rerulated by el Policy Bued on put expertence and the AEC. During this period AEC reruls:.
commenta and adytce of the pub!!c. ed the radiation safety of sorkers at:d AGENCY; Nuclear Regulatory Com. other FedersJ agencies, the States, and the general pub!!c cruf the safety and mission.
NRC s Advisory Committee on the efficacy of radloactive drugs at:d de.
ACTION: F1nal Polley Statement.
Ms 11 cal Uses of Isotopes the Comrois-vices with respect to patients. AEC gj, hu developed the following state-regu.lation included production of tr.e
SUMMARY
The Nuclear Regulatory ment of geners] polley to gu!de sta reg-radlotsotope, manufacture of the fas!
Comminion (NRC) has the fo!Jos'ing ulation onhe mecica.1 uses of radlotso-radioactive drug product or device. da po!!cy statement regardtrts NRC's topes:'
tt! button, use and disposal of the prcd.
future role in regulating the medicaj JA
- 1. The NRC wiu continue to rerulate ucts. f;.1975. the FDA terminated the uses of rad;olsetepes. This NRC polley the roed! cal uses of radioisotopes u exemption for radiopharmaceunct.3.
statement is intended to inform NRC necessary to provide for the radiation stating that it sould now regulate the fleensees. other Federal and State safety of workers and the general safety and efficacy of rad;cacta e publ$.he NRC Wlu reruiste the radl-drugs with respect te patients (As agenc6 and the public of the Com as 2.
noted later in this statement. FDA mission's general intention regarding atton safety of patients where justified does not regulate the physician's rou.
the regulation of the medical uses of by the risk to patients and where vol.
radioisotopes. It is expected that tine use of radiopharmaceuticata ) At untary standards or compliance with the same time. NRC sithdres frem future NRC actidtfes in the meical these standards, are inadequate.
regulating radioactive drug safety and area. such as premulgatlen of riew reg. K
- 3. The NRC stu mittimize intruslon efficacy stating that it sculd regulate ulations and development of coepera. 1.nto medical fudsments affecting ps*
the radiation safety of the sorkers tive relationships sith other Federal tients a.nd into other treu traditional-and the pub!!c. The 1976 Me'iical agencies, will follow this statement of ly considered to be a ps.rt of the prac-Device Amendments to the Food. Drug NRC policy.
tice of.nedicine.
and Cosmetic Act extended FDA's au.
ETTECTIVE DATE: February 9.19'9.
II. RArtcM Att thority over med4 cal devices (inclutng devices containing radioacthe matern FOR FURTHER INFORMATION The NRC and its predreessor the als) in a way samljar to its authcrity CONTACT:
Atomic Energy Commission have regu-over drugs.
Mr. Edward Podolsk. Office of lated the medicM uses of radloisotopes NRC's authority to regulate domes.
I Standards Development. U.S. Nucle. since 1946. AEC recogni:ed that physi-tjeally the medical uses of byproduct at Regulatory Commission. Wuh-cla.ns have the primary responsib!!!ty material Ls found in the Atomic ington. D.C. 2C555 (Phone: 301443 for the protection of thelt patients Energy Act of 1954. u s. mended For
' 860 )'
and des!rned its regulations accoretng-exa.mple, section 81 of that Act autho-ly.The physicians were required to be rtzes NRC "to issue general or specille SUPPLEMDTTAL INFORMATION: licensed by the State, and their app!!- !! censes to applicants seeking to use The NRC has developed the fouosing cable training and experience were byrroduct enaterial for * *
- medier.1 three part polley statement regarding evaluated in consultation with the Ad-therapy * * *." Section 81 directs NRC NRC's future role in regulating the visory Committee on the Medical Uses to regulate the manufacture, produc.
medical uses of radictsotopes. On of !.sotopes. This regulation has been tion. transfer. receipt in interstate March 11,19'se the three put policy commerce, accuisition, ownership. pos.
statement wa.s puttished in the Frtra-
'NRC lleenses rsdjotsotopes tn three cate.
session, import and export of berod.
at RectsTta (43 FR 11:08) for pub!!c series: typroduct. nource ud speesat nucte-uct material. Finally. Section 81 also comment Copies of the polley state, as material The NRC does not regulate nat.
directs that:
ment mere sent to all NRC medical U.
g g 7 3,,accet "The commtanton shall not penntt the d.s.
8 or or oc rs censees. the States and 25 professional means any rsatoactive estertal tescent so,.
trituuon of any byproduct material to any l
societies. Federal a.gencies, and indt-etal nuclest materta.li rielded tn or made rs, itcensee. and shall recau or order the recall riduals. The comment period expired dioactive er exposare to the rs41auon inct. of my distributes tr.ateric from any licens.
i l
May 16.1978. Twenty.two comtnents ee. s ho is not ecutsped to obarrse or f ails to sent to the process of productna or utilisans, spectaa ovcaar matand. The term sourc observe such safety stancarits to protect j
sere received. Nine commenters fa.
l voted all three parts of the policy meanal maana t tl urtnlurr. thorium er any c[h taj tsh ty thd may be p,
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statement. four comtnenters opposed 7gu,onthe
- f. k s^h ch
,m,
e t n by sten of law or terulation of the Comm:s.uon i
one part of the polley statement and wetsht one twenueth of one percent to 05't.,
or in a manner ether the u disclosed in ntne commenters addressed spectfle or more of ti: ursnaum. till thortum or sitti th' 8DD1*188" th8f*' *PP''8 'Y Lh' tssues discussed tn the March 11.1978 a.nr cometnation thereof. Source matertal commissiort Tuts.At RtctsTta notice. The com. does not induce spectu nuclear osaterial.
Commisston regulations. for the ments are discussed in Section II.
3*'r88' "cI'er muenar means sta pluton).
most part set forth in 10 CFR Parts 30 Cople.s of the comments may be exam-un. urutum 233. urantum erartched in the through 35. were promulgated to carry ined in the NRC Public Document
$t,$**,3dr$,'"g*,h',3rN d t[ar y ot tU cut the broad teru! story scheme en.
88 Room at 1711 H Street. N.W., Wash. foregotror, but doca not include sourte r. ate.
visaged by section 81. For examrde.
Inston. D.C.
rtal.
Part 35 establishes regulaticris specific floteat flGilrII. VO4 M. WO. 29 ittgaf. Filet;atY 9.1979
1 RULE 5 AND REGULATION 5 8243 to human uses of byproduct material.
The NAS-BLTR 8 repon discusses The regulations try to find a ta!ance QA's statutory authority (Federal limiting the exporure of the popula. betseen adequate controls and asoid.
3 Food. Drug and Cosmett: Act, as t"*. to medical applications of ionizing ance of undue interference in meo::a!
amended. 21 U.S C. 301 et sec.) does radlauon. That report shich includes judgmenta. A consequence of too not diminish NRC's authority. Where all medical uses of ioniz!r: ratation. much regulation could be poorer NRC's and FDf.'s authorities overlap, shots an agerage dose rate from health etre delivery to patients. A con-the respective autherttles can be hat.
radopharmaceuticals of I mrem / year sequence of leaving to physleians the rconized by interagency agreement.
and an average dose rate from dag.
The centraj Cuestion is a cuestion of postic radology of 72 miem/ year in majority of the dectslons concerning i
their patients is that the physielans lation of phystelans,The tightest terJ.
52 make mistakes.
o hat ex ent s'ho d t e protec.
e follos'teg Quotation 13 from the decisions by Ted.
tion of the Dattent be considered in NAS-BT.IR report:
ernt. State and professlenal groups sill NRC's reguladon of the medacal use of in de foreseeable future, the major con.
not be able to prevent future incidents byproduct material?
tabuton to radtauon esposure of the popW*
in the medical uses of radlotsotopes.
From the standpoint of stdhortfF. It lation wit! continue to be catural baca.
W Gmmisskn n' ewes mst is clear that NRC can regulate the stound with so average shole body dose of medlcal uses of byproduct materlaj to about 100 mrrm/rvar. sad med: cal spo!!ca. FDA regulates the manufacture and protect the health and safety of users tions whkh now contribute comparable es.
Interstate distribution of drugs. Ine!ud.
of this material, for instance, patients. posures to wwus tissue of the body. Wdi.
ing those that are radioactive. QA In licensing the possession and use of cal esposures an cot under control or guld.
also regulates the investigational and byproduct material. NRC establishes ance by reeulation or tav at present. The research uses of drugs as se!J as the use of lones radtation to medicine is of specific ruldance on doses and proce.
!!mits within which physicians exer-etse professionaj discretion. From the f,'g5",*,us ca$ bem' dures found in the product tabehng.
e t
gn standpoint of pohey, these limits pl shed without loss of ber efit and at rela. Hosever. FDA does not have the aJ.
l depend upon how NRC vters the po-twelr low cost. The aim ts not onJr to thority to restrict the routine use of tential hazard to the patient's health reduce the rsdistion exposure to the snes. drugs to procedures (described in the and safety in the uses of the byprod-vMus] but also to have procedares cameo product labeling) FDA has accrosed uct matertal. The greater the potential out aIth mazunum efficiency so tr.at there as safe and effective. Indeed. NRC s hatard to a patient from the byprod. enn be a centhr.: increase in med. cal the only Federal Agency that is cut.
uet matertal or its use by a physician, benefjts accompar.Jed by a tr.trumars rada, rently authorised to regulSte the rCJ-the more NRC may elect to circum-suon espoan Line use of racoacuve crus from the scribe steu that might otherwise be NRC will act to he'p ensure that ra. standpoint of reducing uns ecessary ra.
regarded u within the dtseretion of dJatJon exposure to pauent.s is as low &ation exposure to patter _ts.
the physician, as is reuonably achievable, consistent The Commission betjev::s that the The first part of NRC's policy state. with competent medical care and with diagnostic use of radoactive drugs is.
ment indleates that NRC s111 continue minimal L= trusion into medjeal JJdg-In most Cases. Clearly an area of let' to regulate the medical uses of ra.diol-ment NRC till not exercise regula-radiation risk to patients. Therefore.
sotopes u necessary to provide for the tory control in those areu s here. NRC sL11 not control physicia.n's pre.
radiation safety of workers and the upon careful examination, it deter-rogauves on patient selection, instru-general public.* This is the traditional mines that there are adequate regula-ment selection, procedure selection.
regulatory function of NRC for all tions by other Federas or State agen-drug selecuon and dose level for most uses of byproduct, source and special cles or well administered professional nuclear material It is a regulatory sta.ndards. Wherever possible. NRC daposuc uses of raceotopes. For role that was not questioned by any of will work closely with Federal a.nd a]J therapeuuc uses of racosethe the commenters but, rather. It wu State agencies and professional groups drugs. and in certaIn dagnostic uses,
consistently recognised as a necessary in designing new voluntary guidance for example, the use of puesphorus 3.
role in the meccal uses of radictso. for practluoners to !!m.!t unnecessary for locali:auon of eye tumorwtbc
- topes, patient rsdisuon expostre.
risk to patients is not low. The risk of NRC's regulation of the radiation The Llutd part of NRC's policy state, tissue or orts) damage (or even death) safety of workers and the generaj ment Ind! cates that NEC WLil mini. is inherent in the.ae of therapeutic public in the medical uses of radioiso. mize its intrusion into medical judg. levels of rsdloacuve drugs. NRC si;l topes Ls rellnquished by NRC to Agree. ments affecting the pauent and into continue to rsstrict the uses of thern-ment States; does not overlap with other areas traditionally considerew to peutic and certain diagnostic rsdioac.
FDA's acuvities; Ls Ln harmony with be a part of the practice of medicine. Live drugs to the indicated procedures regulation by the Department of The Commission recognizes that phy-that have been approved by FDA. The Transportation. Social Security Ad.
siclans have the primary respor. stb!!!ty NRC will not control the physicians' ministration and the Joint Com.ots, for the protection of their patients. prerogauves on patient selection and sion on Accreditation of !!ospitals; and The Commission believes that bute Lnstrument selection for therapy pro-covetails with Occupational Safety dectstons concerrd g the diagnosis and cedures, because these procedures are and Health Administration regulation treatment of dJeue ad a part of the so specialited and flatitnt specific l
of the work place for the use of natu, physician. patient relattorv.h:p and are C1ngress recently gave FDA authon.
rally occurring and accelerator pro, traditionally considered to be a part of ty to regulate medical devices. Similar t.uced radioactive materials.
the practlee of roedicine. 4RC regula-to FDA's authority to regv!ste drugs.
The second part of NRC's policy tions are predicated on the assumption but with additional authority to re-statement indicates that NRC w!!! res. that properly trained and adequately strict the routine use of medical de-ulate the radiation safety of patients Informed physic:a.ns s t'J make deca-vices as may be necessary to provide where justified by the risk to patients afons in the best interest of theJ IJa-Feuen4ble assurance of their safety l 'At"'
and shere voluntary standards, or and effectiveness. FDA has not yet compliance with these standards, are had sufficient time to implement its l
inadequate. As noted before. NRC hu
' National Acadernr of Sc'enees ACMsory full authorlty to regulate medics.! de-l the authority to regulate the radiation Comrnattee on the BiotericaJ Effecu of lon-vices containing byproduct. source er I
safety of patients.
Lttne Radations (NAS BC.R3 report. TAs l
f.fkets on Pepa!stions ef I.posve to Low spe 1st nuclear mater'al. There. fore.
1 NRC will conunue to restrict 94..st-l urers af tonsegne Jtedterius Nar:enet
'The tenn eeneral puttle in this state.
Accom, c/ gcwners-Nortonal Aescoern clan s uses of these medi:al c!ertees.
1 ment specifically excludes patients.
Cc o ncil, Waarungtori. D C. 45723.
both for diagnosis and therspy. to nonat mnm. vek u. s.o. n_nmae.'nman e. im i
1 1
TULES AND REGULADON5 8244 Two commenters objected to NRC's As noted in the proposed pohey those procedures that NRC hu det:r. r. M*lon of patient radiation safety statement. NRC is studying the var-mined (in consultation with its Adviso-tous allied health certtileatten pro-ry Cornmittee on the Medict! Uses of becuse they believe that NRC does Isotopesi to be safe and effective.
not have the authority to regulate pa.
trams currently in effect or bemg The Commiaston does not consider tient safety. They note that NRC's en.
drafted by other Federal. State and professiont! groups. If the coserage equipment calibration. Quajifications ab!!ng legislation does not specifically provided by these prorra.ms 13 not ade-
-of paramedical personnel or reporting mention the radfation safety of ps.
Quate to protect the patient from un-to NRC misadtninistrations of radiose. tients. They believe that patient necessary radiation exposure. NRC the material to be esclusively the safety is the resperafbf!!ty of the phy. will work stth these EToups to deselcp practice of medicine or a part of physi-stefan, a responsibi!!ty that esAnot be a new NRC proposed rule for the clan patient relationships. The Com-shued. They belfeve that the Commis, training of aliled health personnel.
mission intends to regulate these treu slon is in error to equate patients with There were five comments on the of patient radiation safety where JustI* the public and to consider patients as specific subject of nuclear pharmsetts fled by the risk to patients and where users rather than recipients of radio, trsdlopharmacles).
voluntary standards, or comp!!ance active materiaj.
One commenter urged NRC to dis-with these standards, are inadequate.
As noted in the ana.!ysis of the simi.
tinguish between radiopharmacists lar comment above. the NRC's overrtd. working in a hospital setting and those
!!! Disecsstow or Pt stic Cowwcyrs ing contreastonal mandate is to pro. worklng in a retail environment (com.
A. cowworTs on Tut rotter sTArewTNT teCt the het!!h and safety of the me*etal nuclear pharmacyL This com-public. The patient is a member of the menter also noted the complexity of One commenter opposed the use of pub!!c. notwithstanding the Commts. the problem of definitjon then the the general term radfotsotopes" la s!on's recognition of physicians' prima-hospitaj bued radiopharmacy prm the first part of the po!!cy statement.
ry respons!billty for protection of vides rtdlopharmaceutica.!s to other This cornmenter tas concerned that, their patients. The policy statement hospitals and practitioners in its area.
if taken out of the context of the foot, End. tndeed, all of the Cornmission's As noted in the proposed po!:cy note. It could be Interpreted to include actions in regulating the medica.! uses statement, the NRC will defer to the r:aturt!!y occurring and accelerator of radioisotopes. Eck.newledge the sec-Food and Drug Administration (FDA) produced radio!sotopes.
ondtry but necessary role cf NRC in restrding a determination of those ac-The Commlasson believes that the regislating the rtdlation safety of pa.
livities of nuclear charmacles that st!!
general term " radioisotopes" is plain tients. The Commtaslon tiso considers be considered manuf teture and those Eng!!sh and easily recernized by the puche. It wu preperly footnoted in patients to be both users and recipl. settvities that will be considered the the policy statement to include the ents of rtdioactive materit!. However. ordmary praedce of phtmacy (com-more cumbersome but specific terms: the distinction.betteen receipt and pounding and dispensing),
byproduct. source and special nuclear use of radlotetive mat:rtsts is not Four commenters objected to NRC's material and to exclude naturally oc-meaningful in this case because NRC licensing nuclear pharmacies to dis-cumns and accelerator produced ra-regulates, among oth:r things, recetpt. tribute only those feroducts that they dioactive material.
pouestion, use and transfer of byprod-have prepared from FDA appresed j
One commenter, in opposition to uct. sourte and specit! nuclear matert-radiophamsceudcals or reagent kits.
NRC's regulation of pattent radiation al in protecting the health and safety One commenter cited the practice of safety, suggested that NRC 11rnit its of the public.
nuclear pharm &cles supplying radio-role to the tsdiation safety of the hos, chemicals to researchers t he use
- 3. CoMID'TS oN srtetric Itsns them on humans under their own pital sttif and the genert! patient population. He belteves that pattent Thm wm six comments on the FDA " Notice of CltLmed Investigation.
dos! metry is & responsibility of the in.
Question of rep rting misadministrs-El Demption for a New Drug"(!NDL dividual tnstitution and not NRC. This na radkacme matentl he One commenter noted that FDA pet.
commenter feels t. tat NRC should CCMmtDtm CDD08'd &My MLE&dmin!s-mits nuclear pharmacies to operkte in first require Edecuate sta.ffing. ta..lud.
trstion reporting and three corn-the Lbsence of a final determinat.cn of ing a board certt!!ed phystettn or rs, menters offered suggestions on how their status, providing they meet all diopharmactst and a radiation safety they should be reported. All of the State and local phtrmaceuttet! regula, officer, and then essentially leavt the comments will be considered in dealing tions. The two other commenters institution alone regarding dosimetry, with NRC's newly proposed misadmn-charactertzed the NRC's restrtettons instrumentation, calibration, drug pro-1stration reporting requirement shat on the distribution of curement or any other function con. was published in the Ptzcut, RretsTs* radiopharmaceuttetis by nuclear phar-aldered to be the practice of med!citie. for public comment on July 7,1978 (43 rnacles as an unwarranted intruston into the practlee of phs.rmacy thtch is NRC does require the licensee to FR 20297).
staff its operation with a tsdittlon There s ete six comments on the spe, terulated by the States.
safety officer and a phystetta (not cific issue of partmedic4J training, NRC licenses nuclear pharrnattes to Fiecessarily board certified) trained to Three commenters belleve that it is distribute radloactive drugs that hue administer tsdionettve material or rs.
unnecessary for NRC to become in, been approved by FDA. This includes radioactive drugs subject to an FDA.
dittion to patients. However, the Com, volved in paramedlcal training because approved "New Drug Appitettion" mission cannot limit its regulatory role to protecting the hospital staff and several organizations are ajready pro. (NDA), or " Notice of Clairned Investi.
the genert! patient populition and at tidirig or developing minimum stand. rattent! hemption for a New Drug" the same time fulfill its congTesalonal Erds, guidelines or certificattert. One (INDL NRC rettes on IT) A approsal of mandate to protect the het!th and commenter be!!eved that NRC should radionettve drugs because NRC has safety of the pubile as regards source, be involved in th!s area because the not regulated the safety and effeettse.
byproduct and special nuclear mater!. technologist. not the physician, does ness of radiotttive drugs since 194
- 11. The patient being treated or d!ag. most of the work with rtdlotsotopes. Also there tre not many States that nosed with radionettve matettal, u Two commenters believe that isdlolog. are equipped to regulate rad!cactne te!! u the general public sho may be leal physic!sts should be separated out drug safety and effectiveness.
exposed to radiation u a result of that from other ptrarnedical personnel and treatment. tre all members of the one of these cornmenters offered a Dated at Washington. D.C. this 1st
=
pubtle to be protected by NRC.
definition of radiological physteist, day of February 1979, e
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