ML19289E270
| ML19289E270 | |
| Person / Time | |
|---|---|
| Issue date: | 03/30/1979 |
| From: | Gossick L NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | Trible P HOUSE OF REP. |
| Shared Package | |
| ML19289E271 | List: |
| References | |
| RULE-PR-2, RULE-PR-30, RULE-PR-35 NUDOCS 7904110030 | |
| Download: ML19289E270 (10) | |
Text
(
f 4
UNITED STATES
'es NUCLEAR REGULATORY COMMisslON I I Y o
WASHINGTON, D. C. 20555 o h'-
5
/
g*****f UAR T79 The' Honorable Paul Trible THIS DOCUMENT CONTAINS United States House of Representatives p00R QUAUTY PAGES Washington, D. C.
20515
Dear Congressman Trible:
Thank you for sending NRC the editorial " Patient Exposure to X-Rays:
"Whose Responsibility." by Suresh K. Agarwal, Ph.D., and Theodore E. Keats, M.D., that was published in the Virginia Medical Journal, February 1979.
At the Federal level, the Food and Drug Administratiori's Bureau of Radiological Health (BRH/FDA) has the basic responsibility for regulating x-rays.
I am sending a copy of this letter and the editorial to Mr. John Villforth, Director, BRH. He can provide you with a more detailed and informative response to the editorial from BRH's perspective.
Because there are many parallels between the use of x-rays in medicine and the use of radioisotopes in medicine, which NRC does regulate, you may be interested in some recent activities of NRC in the area of patient radiation safety.
Drs. Agarwal and Keats express a valid concern about the radiation safety of patients and particularly the training of technologists.
Both FDA and NRC have shared that concern and both agencies are doing something about it.
In February 1979, NRC published a policy statement on the regulation of the medical uses of radioisotopes that I am enclosing for your information.
Regarding patient safety the policy statement reads:
The NRC will regulate the radiaticn safety of patients where justified by the rick to patients and where voluntary standards, or compliance with these standards, are inadequate.
Recently, NRC has taken several actions in this regard:
~
1.
In November 1978 NRC issued a final rule requirisig hospitals to perform radiaticn surveys of patients to make sure that all radioactive sources are removed from patients following therapy.
2.
In January 1979 NRC issued a final rule requiring hospitals to have qualified experts to calibrate their teletherapy units annually.
3.
In the past few days NRC issued an order modifying hospital licenses
.to require special testing of certain radiopharmaceuticals before they are administered to patients.
730411 C O 3C)
~
ppz
The Honorable Paul Trible '
' Copies of these actions are enclosed for your information.
Drs. Agarwal and Keats are concerned about the training of users and, in particular, technologists. Before issuing a license, NRC reviews the tra.ining and experience of the physician and the training and expeiience of the radiation safety officer. Physicians are allowed to delegate certain tasks to technologists and nurses but the physicians are responsible for those delegated tasks.
Thus, under NRC licensing procedure, the physicians are responsible for evaluating the training and experience of their technologists and nurses.
On March 13, 1979, BRH/FDA published a Federal Reaister notice of intent to develop recommendations on voluntary standards for qualifications of medical radiation technologists. A copy of the notice is enclosed for your informa-tion. The initial recommendations will address the qualifications of medical diagnostic x-ray personnel.
Subsequent recommendations will address qualifications for radiation therapy and nuclear medicine technologists.
NRC plans to cooperate with BRH/FDA in their efforts to develop standards for technologists' qualifications.
Regarding the editorial's final point about the relative emphasis within the Federal sector between the regulation of nuclear power and the regulation of medical radiat in, for many reasons Federal attention is focussing on the regulation of the medical uses of ionizing radiation and, in particular, on the radiation safety of the patient. On February 27, 1979, the Secretary of the Department of Health, Education and Welfare issued a draft report from an " Interagency Task Force on Ionizing Radiation" which recommends, among other things, "... improving the availability, training, and credentialing of personnel who administer radiation-related procedures...".
At the Federal level the emphasis on regulating medical radiation is certain to increase in the future.
Thank you again for sending the editorial.
I trust that I have been responsive to your request by conveying the essentials of NRC's concerns and actions in regulating the medical uses of radioisotopes.
Sincerely, cc: John C. Villforth 6
The Honorable Paul Trible
Enclosures:
1.
NRC Medical Policy Statement 2.
Patient Radiation Survey Rule 3.
Teletherapy Calibration Rule 4.
' Order to Medical Licensees 5.
BRH/FDA Notice of Intent S
=
82d?,
RULES AND REGULATIONS nerally oriented toward assistinh hualified physicians in discharem:
17590-01-M]
L STA N " T " U " *^'
Tine 10--Energy This NRC poi!cf statement is in-the:r responsib:Utles to patients. How-tenoca to tn:orm NRC licensees. other ever, regulation by AEC/NRC has a:
CHAPTER l-NUCLEAR REGULATORY Federal and State agencies and the one time or another encompassec puette of the co= mission *s general in-nearly every aspect of the delivery of COMMISSION tention recarmng tne regulation of radioisotope medical services to pa-the medical uses of radio:sotooes.
tients. The broadest regulation oc.
PART 10-HUMAN USE5 CF tt is expected trtat future NRC activ-curred between 1962 and 1975, when
, BYPRODUCT MATERIALS ities in the med: cal area. suen as pro-mulgation of new reirulations and de-the Food and Drug Administration Regulofian of the Meilical Uses of ul pment of cooperauve relationships (FDA) exempted from its require-ts for new - drugs all Radioisotopes; Statement of Gener- $w his stateme ofNCNiiey r opharmaceuticals regulated by of Policy Based cn past experience and the AEC. During this period AEC regulat-comments and advice of the public ed the rad 2ation safety of woriters and-AOENCY: Nuclear Regulatory Com-other Federal agencies. the States, arj the general public and the safety and mission.
NRC's Advisory Cocumttee on the efficacy of radioactive drugs and de-AC1* ION: Final Policy Statement.
Med! cal Uses of Isotopes. the Comrus-vices with respect to patients. AEC sien has developed the following state-regulation included production of the
SUMMARY
- The Nuclear Regulatory ment of general policy to guide its reg-radiotsotope, manufacttire of the final Commkdon (NRC) has the.following ulation of the medical uses of radioiso-radioactive drug product or device, dis-policy statement regarding NRC's topes *
- tnbution, use and disposal of the prod-future role in regulating the medical
- 1. The NRC will continue to regulate ucts. In 1575. the FDA terminated the uses of radioisotopes. This NRC pcHey the medical uses of radioisotopes as exemption for radiopharmaceuticals.
statement is intended to inform NRC necessary to provide for the radiation stating that it would now regulate the
!!censees other Federal and State safety of workers and the general safety and efficacy of radioactive agencies and the pubgic og the Com-public.
drugs with respect to patients. (As mission s general intention regarding
- 2. The NRC will regulate the radi-noted later in this statement. FDA the regulation of the medical uses of ation safety of patients where justified does not regulate the physician's rou-by the risk to patients and where vol-radioisotopes. It is expected that tine use of radiopharmaceuticals.) At untary standards, or compliance with the same time. NRC withdrew from future NRC activities in the medical these standards, are inadequate.
regulating radioactive drug safety, and area, such as promulgation of new reg-
- 3. The NRC wHl minimize intrusion efficacy, stating that it would regu. late ulations and development of coopera-into medical judgments anecting pa*
the radiation safety of the workers tive relationships with other Federal tients and into other areas traditional
- and the pubuc. The 1976 Medical agencies, will follow this statement of ly considered to be a part of the prac-Device Amendments to the Food. Dru::
NRC policy.
tice of medicme, and Cosmetic Act extended FDA's au-EFFECTIVE DATE: February 9.1979.
II RATtoNAI.E thority over medical devices (including devices containing radioactive materi-FOR FURTHER INFORMATION The NRC and its predecessor the als) in a way sinular to its authority CONTAC1':
Atomic Energy Comhtion have regu-over drugs.
Mr. Edward Podolak. Office of lated the medical uses of radioisotopes NRC's authority to regulate domes-Standards Development. U.S. Nucle-since 1946. AEC recognized that physi-tically the medical uses of byproduct ar Regulatory CommRtion. Wash-cians have the primary responsibility material is found in the Atomic Inston. D.C. 20555 (Phone: 301-443-for the protec:1on of their patients Energy Act of 1954, as amended. For 5860).$
and designed its regulations according-example, section 81 of that Act autho-ly. The physicians were required to be rises NRC "to issue geners! or specific SUPPLEMENTAL INFORMATION: licensed by the State. and their appH-Heenses to applicants seeking to use The NRC has developed the following cable training and experience were byproduct material for * *
- metiical three part policy statement regarding evaluated in censultation 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-rnedical uses of radioisotopes. On of Isotopes. This regulation has been tion, transfer, receipt in interstate March 17,1978, the three part policy commerce, acquisition, ownership, pos-statement was published in the Fcat-
'NRC licenses radioisotopes in three cate-session. import and export of byprod-
- 42. Rrczstat (43 FR 11208) for pubHe sortes: byproduct. source and special nucie-uct material. Finally Section 81 also comment. Copies of the policy state, at matenal. The NRC does not regulate nat-directs that:
ment were sent to all NRC medical 11-F,,"
o he e :n duc r ta a
The Coceon shall not permit the dis-censees, the States and S professional societies. Federal agencies, and indi-means any radioacttre matertal texcept sp,.
tnbuuon of any byproduct matenal to any cial nuclear material) yielded in or made ra.
licensee. and shall recall or order the recall viduals. The comment period expired dioactive by exposure to the radiation tnes. of any d:stributed matenst from any Ucens.
May 16.1978. Twenty two comments dent to the process of voducins or utin:ing ee. 3 no ts not ecutsped to observe or fails to were received. Nine commenters fa.
spectat nuclear matenaL The term soure, observe such safety standards to protect h
vored all three parts of the policy Qte[jmeans 1 onjr ofa-a um. aon a
o use ate al statement, four commenters opposed y
one part of the pclicy statement and chem. cal fonn or (2) cres which centain by tion of law or rervlauon of the Commission reicht one-twentieth of one partent (0.058"c3 or in a manner other than as disciored Ln nine commenters addressed specific or more of U) uranium. U1) thorium or dii) the appi: cation therefor or approved br the issues discussed in the March 17, 1978 any come:nacon thereof. Source maten&g Ccmmissico.
FrataAr. Rrcisita notice. The com-does not incluce special nuetear matenal.
Commission regulations, for the ments are discussed in Section II.
Dec5Cl "*Cl'ar atenet means t ti stutoru-d *^ $. most part set forth in 10 CFR Parts 30 Copies of the comments may be exam. Q"g'*yj
'$C$'7 g througn 35. were promu!Cated to car-e ined in the NRC Pubue Document matend artu: eta:Ir ennened or any of tne out the broad regulatory seneme en-Room at 1717 H Street. N.W., Wash-foregotng. but does not include source tnste.
visaged by section 81. For examp;e.
ington. D.C.
nal.
Pr.rt 35 estabbnes regulations speedic FiofE AL etGl tit. VOt. 44. NO. 29-FRIDAY. f tSR'.*ARY 9. W9 ENCLOSURE 1
RULIS AND REGULATIONS 8243 to hurnan uses of byproduct material.
The NAS-BEIR 8 report discusses The regulations try to find a balance FDA's statutory authority (Federal limiting the exposure of the popula-between adequate controls and avoid-Food. Drug and Cosmetic Act, as tion to medical appilcations of ionirng ance of undue interference in med! cal amended. 21 U.S.C. 201 et seq.) does radiation. That report, which includes judgments. A consequence of too not diminish NRC's authority. Where all medical uses of ionizing ractation. much regulation could be poorer NRC's and FDA's authorities overlap, shows an average dose rate fro = health c.tre delivery to patients. A con-the respective authortues can ce har. radiophannaceuttesis of 1 mrem / year sequence of leaving to phys:ctans the moruzed by interagency agreement.
acd an average dose rate from c:ag-majority of the decisions concerning The central question is a que:non of nos :e rac:oicgy of 7 mrem / year in their patienta is that the physicians.
1970.
Policy not cut. horny, namely:
will make mistakes. The tightest regu-To wbat extent should the protec-The following quotation is from the g
og
.gg. decisions by Fed-
,AS-E..R repert.
tion of the patient be considered in eral. State and professional groups will NRC's regulation of the medical use of In the foreseeable future, the maior con-not be able to prevent future incidents byproduct material?
tnbutors to radiation exposure of the popu-in the medical uses of radioisotopes.
From the standpoint of au!hority, it lation w.'11 conunue to be natural esca.
The ' Con
- Won recognizes that is clear that NRC can regulate the ground w:th an average whole body dose of FDA regulates the manufacture and medical uses of byproduct material to about 100 mrem / year. and medical appi ca.
protect the health and safety of users. tions which now contnbuu compa atie ex.
In*entate distribution of drugs,includ-of this material, for in:tance, patients. posures to vanous tissues of tne body. Medi-ing those that are radioactive. FDA In licensing the possession and use of cat exposures are not under control or guld-also regulates the investigational and byproduct material. NRC establishes ante by regulation or law at present. The research uses of drugs as well as the u38 Of 1 F#C8 Tadi1110D 13 M*d C13' 18 I specific guidance on doses and proce-limits within which physicians exer-cise professional discretion. From the dures found in the produt labeh re expo si e t is ca. be acco However. FDA does not have the au-standpoint of polley. these limits pushed othout loss of benefit and at rela-depend upon how NRC views the po ' tively low cost. The su is not only to thonty to restrict the routine use of tential hazard to the patient's health reduce the radiation exposure to the indi.
drugs to procedures (desenbed in the and safety in the uses of the byprod-vidual but also to have procedures earned product labe!!nz) FDA bas approved uct material. The greater the potential o t with manmum efficiency so that there as safe and effective. Indeed. NRC is hazard to a patient from the byprod. can be a cont:auing tacrease in medical the only Federal Agency that is cur-uct material or its use by a physician, benefi:s accompanied by a minimum raci-rently authorized to regulate the rou-the more NRC may elect to circum-ation exposure.
tine use of radioactive drugs from the scribe areas that might otherwise be NRC will act to help ensure that ra-standpoint of reducing unnecessary ra-regarded as within the discretion of diation exposure to patients is as low distion exposure to patients, the physician.
as is reasonably achievable, consistent The Commi" ton believes that the The first part of NRC's policy state-with competent medical care and with diagnostic use of radioactive drugs is.
ment indicates that NRC will continue mMimM intrusion into medical judg-in most cases, clearly an area of low to regulate the medical uses of radiot-ments. NRC will not exercise regula-radiation risk to patients. Therefore, sotopes as necessary to provide for the tory control in those areas wnere. NRC will not' control physician's pre-radiation safety of workers and the upon careful examination. It deter-rogatives on padent selection, ins ru-general public.' This is the traditional m=es that there are adequate regala-ment telection, procedure selecuan.
regulatory function of NRC for aff tions by other Federal or State agen-drug selection and dose level for most uses of byproduct, source and special cies or well a"-tered profess:enal diar.os2 uses of radotsotopes. For nuclear material. It is a regulatory standards. Wherever possible. NRC all therapeutic uses of radioactive role that was not questioned by any of will work closely with Federal-and the commenters but. rather, it Tas State agencies and professional groups drugs, and in certain diagnostic uses-consistently recognized as a necessary in desgning new voluntary g:udance for exa=ple, the use of phospnorus-32 role in the medical uses of radioiso-for practitioners to U~"
unnecessary for locall:stica of eye tumors-the topes.
patient radiation exnosure.
risk to patients is not low. The risk of NRC's regulation of the radiation The third part cf NRC's po!!cy state-tissue or organ damage (or even death) safety of workers and the general cent indicates that NRC cdl c:ini-is inherent in the use of therapeune public in the medical uses of radioiso-mlze its in rusion into medical judg. levels of radir i;ve drugs. NRC TCI topes is relinquished by NRC to Agree-ments affecMag the pa !ent and into continue to - met the uses of therar ment States: does not overlap w;th other areas traditonally cons:dared to peutic and ceu.us diagnostic radioac-TDA's activities; is in harmony with be a part of the pracMee of medme. tive drugs to the indicated procedures regulation by the Department of The CO "~*cn recognces that phy-that have been approved by FDA The Transportation. Social Security Ad.
sicians have the pnmary respons:bd!!y NRC will not control the phnicians' ministration and the.foint ComcMa. for the protection of their patents. prerogatives on patient selection and sion on Accreditation of Hospital:: and The CommMion believes that basic instrument selection for therapy pro-dovetails with Occupational Safety decisions concerning the diagnos:s and cedures because these procedures are and Health Admini:tration regulation treatment of disease are a part of the so spe+ed and patient spec:IIc.
of the work-place for the use of natu-physic:an-patient reladonsing and are Congress recently gave FDA authort-
' fally-occurring and accelerator pro-tracitionally cocsidered to be a part of ty to regulate medical devices, similar duced radioactive materials.
the practice of mecicine. NRC regula-to FDA's authonty to regulate drugs.
The second part of NRC's policy Mods are prehed on t.w assutnpuon statement indicates that NRC will ret-that properly trained and adequately but with additional authority to re-ulAte the rad.'1 tion safety oi patients informed physicians wCl mate deci.
stnct the routin= use of medical d**
where justified by the rist to pa:1ent3 sions in the Oes" in*erm of the:r pa-vices as may be necessary to provide g;ents, reasonable assurance of their safety and where voluntary standards, or and effectiveness. FDA has not yet compliance with these standards are had sufficient time to implement its inadequate. As noted before. NRC has
'Nat: anal Academy of Sciences Aditsory full authonty to regulate cecical de-the authonty to regulate the radiation Committee on the D;o:ct: cat Effects of Ion-
<afety of patients
- cn amuons GL-n mport. Tae vices ccntain:r" bY7 red""-*
s.ource of E!ccts on Pon:anons of Encsure to Low ID'*;15 C2;I'3T mal
- Mal-MC?e.
NRC WCl continue to restr'ict physi-Ece(s of Iour.r.g.tasimon..va:ronag
'The te m eeceni pub!!c in th:s s:ste-Accarvtv of Sc tr.cermvmal Research cian's uses of these mec;;al devices, ruent specdles. y educes paMents.
Coc.c:l Washmgton. O.C. (137D.
both for d:sgnosis and therapy, to TECtkAL 2fCitTI2. VCt. 44, NO. 29-r2l PAY. Fl!!tt:A2Y 9.1979 e
e
8244 RULES AND REGULATIONS those procedures that NRC has deter-Two commenters objected to NRC's As noted in the proposed policy mined (in consultation with its Adviso-regulation of patient radiation safety statement. NRC is studym the var-ry Committee on the Medical Uses of because they believe that NRC does fous allied health certification pro.
Isotopes) to be safe and effective.
not have the authority to regulate pa-grams currently in effect or bein:
The Commission does not consider tient safety. They note that NRC's en.
drafted by other Federal. State and equipment calioration. Qualifications abling legislation does not specifically professional groups. If the coverage of paramedical personnel or reporting mention the radiation safety of pa-provided by these programs is not ade-to NRC misadministrations cf radioac-tients. They believe that patient quate to protect the patient from un-tive material to be exclusively the safety is the responsibility of the phy.
necessary radiation exposure. NRC practice of medicine or a part of physi-sician, a responsibthty that cannot be will work Mth these groups to develop clan-patient relationships. Che Com* shared. They believe that the Commis. a new NRC proposed rule for the mmion intends to regulate tnese areas sion is in error to equate patients with training of anled health personnel There were five comments on the of patient radiation safety where just1* the public and to consider patients as specific subject of nuclear pharmacies fled by the risk to patients and where users rather than recipients of radio.
(radiopharmacies).
voluntary standards, or compilance active material.
One commenter urged NRC to dis-with these standards. are inadequate.
As noted in the analysis of the simi.
!ar comment above. the NRC's overrid-
'{
IOD2f*y2]3 III. DtsCUssioN oF PUsuc Commrrs ing congressional mandate is to pro-working in a retail environment (Com-A. comms on m PouCY STATEMENT tect the health and safety of the mercial nuclear pharmacy). This com-One commenter opposed the use of public. The patient is a member og the menter also noted tne complexity of the general term "radioisctopes" in public, notwithstanding the Ccm15-the problem of def!nition when the sion's recognition of physicians
- pruna-hospital based radiopharmacy pro-the first part of the policy statement.
This commenter was concerned that, ry responsibility for protection of vides radiopharmaceuticals to other if taken out of the context of the foot. their patients. The policy statement hospitals and practitioners in its area.
note, it could be interpreted to include and. Indeed all of the Commission's noted roposed po naturally occurring and accelerator actions in regulating the medical uses of radioisotopes, acknowledge the sec-Food and Drug Administration (FDA) produced radioisotopes.
The Commission believes that the ondary but necessary role of NRC in r
general term " radioisotopes" is plain regulating the radiation safety. of pa-t nu at t at s
-l I:nglish and easily recognized by the tients. The CormfWon also considers be considered manufacture and those public. It was properly footnoted in patients to be both users and recipi-activities that will be considered the
{
the policy statement to include the ents of radioactive material. However. ordinary practice of pharmacy (com-more cumbersome but specific terms: the distinction between receipt and pounN and dispenshgh y
byproduct. source and special nuclear use of radioactive materials is not Four commnters cWted to NRC,s
[-
material and to exclude naturally oc-meaningful in this case because NRC curring and accelerator produced ra-regulates, accng other things, receipt, fribut only tho e p o e that the C
dioactive material.
possession, use and transfer of byprod. have prepared from FDA approved 5
One commenter, in opposition to uct, source and special nuclear materi-ra&phamaceuW e ant WA NRC's regulation of patient radiation al in protecting the health and safety One commenter med be one,of safety, suggested that NRC limit its of the public.
nuclear pharmacies supplying radio.
role to the radiation safety of the hos-chemicals to researchers who use
- 3. COMMENTS oN sPICIrtC tssCEs pital staff and the general patient them on humans under their own population. He believes that patient There were six comments on the FDA " Notice of Claimed Investigation-dosimetry is a responsibility of the in-questi n f rep rting misadministra-al Exemption for a New Drug" (IND).
dividual institution and not NRC. This tions of radioactive material. Three One commenter noted that FDA per-commenter feels that NRC should c nunenters opposed any misadmints-mits nuclear phannacles to operate in first require adequate staffing,includ-trati n reporting and three com-the absence of a !!nal determination of ing a board certified physician or ra-menters offered suggestions on how their status. providing they meet all diopharmacist and a radiation safety they should be reported. All of the State and local pharmaceutical regula-officer, and then essentially leave the comments will be considered in dealing tions. The two other commenters institution alone regarding dosimetry, with NRC's newly proposed misadmin-characterized the NRC's restrictions instrumentation. calibration, drug pro-1stration reporting requirement that on the distnbution of curement or any other function con-was published in the FZDERAI. REctsTER radiopharmaceuticals by nuclear phar-sidered to be the practice of medicine, for public comment on July 7,1973 (43 macies as an unwarranted intrusion NRC does require the licensee to Into the practice of pharmacy which is FR 29297).
staff its operation with a radiation Then were six comments on the spe-regulated by the States.
safety officer and a physician (not cific issue of paramedical training.
- NRC licenses nuclear pharmacies to necessarily board certified) trained to Three commenters believe that it is distribute radioactive drugs that have administer radioactive material or ra.
distion to patients. However. the Com. unnecessary for NRC to become in.
been approved by FDA. This includes miWon cannct limit its regulatory role volved in paramedical training because radioactive drugs subject to an FDA-to protecting the hcspital staff and several organizations are already pro. approved "New Drug Application" i
(NDA), or " Notice of Claimed Investi.
the general patient population and at viding or developing minimum stand.
the same time fu1Illl its congressional ards, guidelines or certification. One gational Exemption for a New Drug" mandate to protect the health and commenter believed that NRC should (IND). NRC relies on FDA approval of radioactive drugs because NRC has safety cf the public as regards source, be involved in this area because the byproduct and special nuclear materi. technologist not the physician, does not regulated the safety and, effective-ness of radioactive drugs ece 1975.
al. The patient being treated or disg. most of the work with radioisotopes. Also, there are not many States that nozed sitn rad:oactive material, a: Two commenters believe that radiolo;. are equipped to regulate rad:cactne well as the general pubhc who may be ical physicists should be separated out crug salety and effecureness.
exposed to radiation as a result of that from other paramedical personnel and treatment, are all members of the. one of these ccmmenters offered a Dated at V.*ashington, D.C. this In public to be protected by NRC.
definition of radiological physicist, day of February 1973.
FEDERAL ttGl5TER, VCt. 44, NO. 29-FRIDAY, Fit 1UARY 9,1979 e
RULES AND REGULATIONS larly difficult to count iridium.192 and inexpensive and it will also detect Title 10-Energy seeds, which sometimes become dis-any sources lost in the bedelothes or lodged from their encasement in nylon room where the survey is performed.
CHAPTER ILHUCLEAR REGULATORY ribbon). Because a backup radiation Therefore. the afterloaded devices will COMMISSION survey of the patient could have pre-not be exempted frota the require-vented these incidents, on Jtme 23.
ments for a radiation survey.
PART 35-HUMAN USES OF 1978 NRC published a proposed rule in BYPRODUCT lAATERIAL the Fr:2UtAL RrcisTra adding a re-Finally. regulations that define whrd quirement for source counting and pa-is generally considered good practice tient radiation surveys to the existing may seem useless or may even dismay Radiollon Surveys of Therapy
$ 35.14(bX5Xvil) which prohibits conscientious licensees. However, this ggg Group VI licensees from discharging is insufficient reason to forgo these AGENCY: U.S. Nuclear Regulatory patients until all sources are removed. regulations when there !s evidence Commission (NRC).
The comment period ended August 14, that the good practices are not univer.
1978 AGON: Final rule.
Twenty-one comments were re-sal.
\\
SUMMARY
- Certain NRC licensees ceived. Eleven favored the proposal Under the Atomic Energy Act of are authof. zed to treat patients with without qualification. Three com-1954. as amended, the Energy Reorga-temporary implants incorporating ra-menters suggested that bulky after-nization Act of 1974, as amended and dioactive material. NRC will require loaded devices that protrude from the sections 552 and 553 of title 5 of the such licensees to confirm tne removal body be exen2pted from the radiation of the implants at the end of the survey. One commenter suggested that United States Code. notice is hereby treatment by (1) a source count and an X ray be permitted as an alternative given that the following amendment (2) a radiation survey of the patient. to the radiation survey. One com-to 10 CFR Part 35 is pubIlshed as a Failure to account for all implanta at menter asked what was meant by "the document subject to codification.
the conclusion of patient treatment end of the treatment" and one com-In 10 CFR Part 35, f 35.14(b)(5Xvil) has resulted in some instances of un-menter, while favoring the proposal.
is amended to read as follows:
necessary radiation exposure to pa-suggested that the radiation survey tients and members of the general should be performed within one hour S ecific licenses for certain groups public.
of source removal. Four commenters I 33 14 P
mu.myz. DATE The amendment objected to the proposal because' they of medical uses of byproduct material.
becomes effective on December 28, believe that regulations that define e
e
=
what is already good medical practice 1978.
are useless. One commenter objected FOR FURTHER INFORMATION to the proposal because he believes (b) Any licensee who is authorized to CONTAT.
that there are some cases where it use byproduct material pursuant to Edward Podolak. Office of Stand-would be impossible to survey the pa-one or more groups in !!33.14(a) and ards Development. U.S. Nuclear Reg-tient before discharge.
35.100 is subject to the following con-ulatory Commission. Washington.
The wording of the final rule is the ditions:
D.C. 20555 (Phone: 301-443-596S).
same as the proposed and requires a SUPPYNNTARY INFOR$ATION: radiation survey of the patient before discharge. The radiation survey is the NRC regulaticus in 135.14(b)(5Kvil)
(5) For Group VI any licensee who E so re oa The x rsy n
tha pat en t a with c b -.
passive method. Although good prac-possesses and uses sources or devices cesium.137 or fridium.192 tempora y tice.would suggest a radiation survey containing byproduct material shall:
implants remain hospitt.lized until the soon after source removal, the regula-implants have been removed. The pr!- tion has to recognize the ret.lities of mary metlied for confinning that all the clinical setting where other tasks sources have been renioved is to count may have higher priority. Placing a (vil) Assure that patients. treated the sources implanted and count the tig!'t time limit on this essentially sources removed. The sourte counting with cobalt.60, cesium 137 or iridium-quality control function may interfere has not always been performed accu-with patient care. However, it is ex.
192 implants remain hospitnllzed until rately, or on a timely basis, tremely unlitely that the licensee will a source count and a radiation survey Some patients have been discharged experience difficulty performing the of the patient confirrn that all Im-from the hospital with radioactive sources still implanted. (It is particu-survey between source removal and plants have been removed.
discharge of the patient.
The suggestion to exempt afterload.
- The most common types of NRC spedfic ed devices is well made. The devices licenses for the medical use of byproduct are bulky relative to the actual source matertal are the Orcup medical licenses (Sec.151. Pub.1.83-703, 68 Stat. 948 (42 under $ 35.14 that apply to those radioactive size and it is difficult to imagine that materials listed in i 35.100. The radioactive Catients would be discharged with U S C. 2201) Sec. 201. Pub. I.93-438, 88 stat.1243 (42 U.S.C. 5841u materials listed in 1 35.100 are divided into these devices in. place. However. NRC str groups, each group havulg similar re-inspectors who are familiar with inci-Dated at Bethesda Maryland this quirements for user trunmg and experi-dents of
{
im I ts 14th day of November 1978.
ence, f acilities and equipment. and radiation rem 11ning in patients, say that this is safety procedures. Groups I. II, and III are an area where the " impossible ** hap-For the Nuclear Regulatory Com-lists of radiopharmaceuticals for diarnostic procedures: Groups IV and V are hsts of wens in spite of great care and precau-mission.
radiopharmaceuticals for therapeutic proce. tions. Also. NRC inspectors have inves.
Lzz V. GossIcr.
dures; and Group VI is a list of radioactive Lfgated an incident where a patient Ezecutit'e Directorfor medical devices for both diagnostic and *was. discharged with an afterloaded O#ti*
therapeutic procedures.
. device in place with the sources loaded. The radiation survey is simple (FR Doc. 78-33229 M!cd 11-M-78: 8:45 aml ftDERAt REGt3 tit. VOL. 43, HO. 229-Ttit$oAY, NOVEMBER 23, 1978 ENCLOSURE 2
- 3. Report to NRC if these measure.
s!bH!tles of the two stencies. It ap-
.7590-01-M]
ments indicate that patienu tnated pears that it wtn be some time before Title 10-EneW by teletherapy umts received a radi-the FDA has standards or guidelines ation dose differ =g from the pre-in place for teletherapy eM1bration. As CHAPTER I-NUCLEAR 2EGULATORY sented dese by more than 10 percent.
they are developed. NRC, wul wors COMMISSION The pubuc was invited to submit closely with FDA to mminu:e overlap.
wntten comments and suggestions on ping regulation by the two agencies.
PART 35-HUMAN USES OF the procesed amendments. The ecm.
One commenter suggested that 11-BYPRODUCT MATERIAL.
ment pened. onginally set to close en censees be required to participate in July 5,1977, was extended to Jdy 09 caHbration chect prcgrams such as Calibration of Teletherapy Units 19;7.
those sponscred by FDA or the Na-U[{
U.S. Nuclear Regulucr7 I. Comiz:rrs os Pnoroszn Rm.z u
m on cou s
e h ra U er kCTION: Final rule.
Mty.nine comments wen neeind.
ns to par @ ate b WW dh Copies of the comments and a detailed tion check programs but wul not re-3UWART: The Nuclear Regulatory analysis cf the ecm=ents may te ex.
quire it.
>mm W (NRC) is amending it3 ammed in the NRC Pubue Document Several commenters did not under.
regens to require medical licens-Room at 1717 E Street. NW Wash.
stand that a qualified expert need not es to (1) enllbrate each telethempy incton. D.C. Approximately one-half actually perform the spot. check mea.
anit annually and (2) perform mcnth. of the ecmenters supported the pro.
surements. The final rule states clear.
17
- pot checks on those calibrations. pcsed rule. Of the re+ der, approxi.
17 that the quanf!ed expert need not The annual full calibrations must be.
mately one.hMf cisa; proved of the actually perform the spot check, but perfornsed by a quMilled expert. The propcsed rule and the other half were the results of the measurements must 32cnthly spot checks need not be per.
rion ecmmittal. Virtually all of the be reviewed by a qualified expert formed by a qualified expert but the commenters offered helpful sugges.
within 15 days.
tesults cI.the spot chechs Inust be re.
tions, most of which were acecmmo.
There were numerous comments on riewed by a quMilled expert on a dated as detailed in Section II belcw.
the section of the preposed rule that timely basis.
" Summary of.lfctor CF.sr7es in f.he would have required reporting to The = nd *
- will help ensure yi :cl Rde".
NRC. and to the patient's referring that a M -* rocarves the prescribed Most of the commenters who disap.
physician, certain InisnAmirtistrations radiati:n da:e by requir2ng that te.
proved of the proposed rule ques.
involving L21etherapy umts. The mis-letherapy udits are properly calibrat. tiened either the need for a rule or ummistraticn reporting requirement ed.
whether NRC vts the apprcpriate fed.
In the proposed teletherapy calibm.
i:FFECTIVI DAT::: The amendments eral agency to require ennbrations of tion rde has been deleted from the secome effective on July 9,1979. Any teletherapy units.
final rule. AH cec.ments received on
'ull calibrations performed in acccid.
The Cc==:ss:en agrees with these this subject will be cons:dered as co='
mee with the procedures in this cc=menters who peinted out that the ments on the more comprehensive pra unendment during the 365 days prior Riverside Hospital incident involving posed mN"'"uwon reporung re.
.o the effective date of this amend.
400 patients was an isolated case and cuirement that was pubbshed in the nent will count as the first full can.
.that NRC's effc-ts to alert other H.
Fz:r:u.t. ErcIstra en July 7. 1973 (43 Iration.
---:,. censees and check on their caHbra.
FR 25297). for pubuc comment.
Novr-The Nuclear Regulatory Commis.
tions were successful. However, the II. Sm.nrJuty or MAJon Citects Dr Tun ton has suematted t2us rule to the Co:mp.
C0m=!ssion helfeyes that the River.
FINAt. RUI.E roller GenersJ for review under the Federsi side incident evidences the =agnitude teports Act, a.: amended. 44 UAC. :st:.
of the-harm which could be caused by NRC has decided.to issue the final
.'he date on which the rule becemes effee.
a single uncalibrated teletherapy u:Ut.
rule Dy c.dding {} 35.01-35.25 inclusive, he. unless adesed to the contrsry, accord-The purpose of this rule is to ensure to 10 CFR Part 35. rather than 1 sty reflects inclusion of the 45. day pened 'that teletherapy units remain proper.
amending }35.13 3.s propcsed. Th::.
- hich that statute aHows for this review (44 ly callbrated throughout their useful change will make the final rule easier FAC. 351:cex:n.
Hees.
to read and underetand. It will also be 3OR tm.uit u.
INFORMATION Those ecm= enters who quest!cned clear that the rule pertains only to te.
- ONTACT:
whether NRC we.s the appropriate letherapy. units and not to other Mrs. Patricia C. Vacca. Division of agency tg recce ca!2 muon of telet6 sealed sources.
mpy umts, pointed to potendal con.
As d!smssed in See I sh,,,.e Puel Cycle and Material Safety
- Off!ce of Nuclear Material Safet CIcts with the Food and Crug Ad=In.
W-- %tration reporting require.
and Safeguards. U.S. Nuclear Regu.
istmdon's (EA) new auhnty under ment of tha ;mposed de 6 hen the Medical Device A=end=ents of deleted.
g3 D
D.
055 (
23:
- 1975. Through the Atomic Energy Act Section 35.21 on full cahbration has of 1954. as amended, and the Energy been expanded to require full caHbra.
UPPLEMEYrARY INFORMATION:
Reorganir.ation Act of 1974. as a=end-tion following any repair cf the teleth-In May 19.1977, the NRC. published ed. NRC has direct reg tlatcry control erapy unit that includes removal of 1 the Fr:rRAI. RrcIs-ra (42 FR 25743) over the human use of byproduct ma.
the source or major repair of the cc=.
reposed amendments to its regula-tenal in teletherapy un:ts. NRC is the ponents associated with the source ex.
- ons pertaining to the human uses of enly Federal Agency with direct regu.
posure asserely and pncr to treating yproduct materials including teleth.
latory control aer the u.se of by; red.
h" *-' m In 135.01 the ter= " sten:fi-rapy units. The proposed amend-uct. matenal and. 3.s such, is certainly cant change." which related to the tents to 135.13 would have required an appregnate agency to require can.
spot.chect measure =ent and win trig-
- letherapy licensees to:
bration of NRC regulated teletherapy ger a recalibration, now reacs " output
- 1. Have a qualified expert perform unit.s. NRC is aware that its responst.
ciffers by more than 5 ;erec'tt.' Sec-all calibration measurements at least biHties and these of EA do overlap in tion 35.21 now inc!udes a performance nce each year:
the area of =ecical devices. NRC and stand.trd of "to an accuracy within =
- 2. Perform spot-check measurements FDA staff memcers have met on sever.
3 percent" for the calibration of te-o their teletherapy units at least al occastor.s to ecoretnate the resport.
letherapy output. Fin 2Hy. } 35.21 now tonthly; and rmtAt ucism, vot. 44. No. 5-MONDAY JanuAnv.s, m ENCLOSURE 3
mcauuem a s ewau u**s... *** w ' n. =**=
va use source or major repair or tne (4) Tne exposure rate cose rate. cr.
calibratien of teletherapy output for components sssociated with the source quantity related in a know manner -
physical decay at Intervals not to.
exposure assembly; and these rates ter one typical set of oper.
exceed one month.
(3) As intervals not exceed!ng one ating conditions: and Under the effective rule. the licensee year.
(5) The difference between the me..
generally will not have to submit the (b) Full calibration measurements surement made in paragraph (b)(4) ci training and ex::enence of the quall-required by paragraph (a) of this sec-this section and the antac:patec fled expert to NRC for evaluation.
tion shall include deterniination of:
output expressed as a percentage c.
Rather.135.24 requires the Ucensee to (1) The exposure rate or dose este to the ant!cipated output (i.e., the value determine, pursuant to the provisicns an accuracy within =3 percent fcr the obtained at last full calibration ccr.
of that section.1f a person is an expert range of field 3::es and for the range rected mathematteauy for pnys:c _
qualified by training and expenence to of distances (or for the axis distance) decay).
calibrate teletherapy units. The licens.
used in mdfation therapy; (c) Spot. check measurements ;-
ee will then keep records of that evalu-(2) The congruence between the ra.
quired by paragraph (a) of this sectier stfon of the expert's training and ex.
diation field and the field indicated by shall be perfonned in acccrdance wit -
perience for inspection by NRC.
the light beam Icc*-~g dev:ce; procedures established by an expe--
A new requirement has been added (3) The unifor :ty of the radation-qualified by training and expertence u-to ensure that dosimetry systems used field and its dependence upon the ori-accordance with !35.24. (A qudi!!e-to calibrate the teletherapy units are entanen of the useful bes=:
expert need not actuany perfor= th; also properly c2Hbrated. Section 35.23 (4) Timer accuracy; and spot-check measurementa.) If a qu::..
(5) ne acoracy of an d! stance fled expert does not perform the spc..
requires that the dosimetry system tzsed 'for full calibraticns has itself measuring devices used for treating check measurements the results c.
humm been calibrated by the National the spot-check measurements thall t2
.(c) Full caUbration measurements reviewed by a quall!Ied experf, with.
- Bureau of Standards (NES) or by one shall be made in accordance with the 15 days.
of three Regional Calibration Labora-tories (RCL). who in their turn are di, procedures reec==enced by the Scf.
en c Co--"ttee en Radiation Dosf-l 35.03 Requirement to calibrate intru-rectly " traceable" to NES. Alternative-metry of the American Association of ments used for fu]I calibration 2-d ly, a dosimetry system used solely for spot. check measurements may be call.
{
ts in Mb G.W in
. spot. check measuremeista.
edtc:ne end Ric?cgj. Vol.15. No. 3' (a) Full calibration measuremen.c.
brated by direct intercompanson with 1
' #P-I*
a system calibrated by NES or one of required by 135.21 shall be perform ~.
the RCI.s.
(d) The exposure rate or dose rate using a dosunetry system th'at he:
values determined in car._ raph (b)(1) been calibrated by the Natict:.
III. PtNAt R et.t of this section shau. be corrected Bureau of S:.andarcs or b7 s 'tr.nen:;
Pursuant to the Atomic Energy Act,
mathemaucany for physical deesy for Calibradon Lt.c<:ratcry L As t-of 1954, as amended, the Energy Reor-intervals not exceecing one month, the Amemenn hi n cf Wact --
ganization Act of 1974. as amended.
(e) Fun cahbration measurements g3 ;, tee 3c.ne. ne de r-Wen and Sections 55 and 553 of Title 5 of required by paragraph (a) of this sec.
shan have been calfbrsted with s the the United States Code, the fonowing tica and phys;eal decay correcticas re-previous two years r.nd after :ny ser e amendments to Title 10. Chapter I, quired by paragnph (d) of this section icing that may have affected syste::
Code of Federal Regulations. Part 35.-
shall be performed by an exper; quali.
calibration.
are published as a dociunent subject to fled by trafning and expenence in ac*
(b) Spot-check measure:nents re.
codification.
cordance with 135.01.
quired by i 35.22 shall be performee 10 CFR Part 35 is amended by using a dosimetry system that hs-adding a new center heading and new 5 35.. Requirement to perform periodie been calibrated in accordance wur si 35.21-35.05. as fonows:
spot. check measurementa of telether.
pangraph (a) of this section. Alterna-P "
tively, a dostmetry erstem tsed Solely Str. czar. RzatrtRmtDrrs roR (a) Any l!censee authorized under for spct.chect =es.surements =sy bi I.Icosrzs
!35.13 to use teletherapy units for caUtrated by direct intereompartsen treating humans shan cause spot.
with a system that has been cantr.tc o f 35.21 Requirement to perform full cal;.
brution measurementa of teletherapy chee.k measurements to be puformed in acecrdance with paragnph (a) w on each teletherapy unit at intervals this section. This alternauve calit?.
uns.
not exceeding one =onth.
tion method shall have been par-(a) Any licensee authorized under (b) Spct-chect measure =ents re-formed within the previous one yee.:
$ 35.13 to use teletherapy units for quired by pang 2::h (a) of t?ns section and after each serv:cing that c ae treating humans shall cause full cab-shall include deter =! nation of:
have affected system calibraticn. Dest.
bration measurements to te per*
(1) T1=er accuracy; metry systems calibrated by tais altar.
formed on each teletherspy unit:
( ) The ecngruence betTeen the r3-native inethod shan not be used for (1) Prior to the first use of the unit diation field and the !! eld indicated by full calibration measurementc.
for treating humarts:
the !!ght bess localinne cevice:
(2) Prior to treating hu-mts:
(3) The accuracy of aP distance f 35.:4 Qualified expert.
(1) Whenever spot.cteca = essure
- measuring devices used fur tretung The licensee shall deter..ine if a ments indicate that the output value humans:
. person is an expert qualified by tra n-i differs by =cre then 5 percent fr In ing and experience to calibrate a te-the value obtained at the last full ca!!.
letherapy unit and establ!sh prece-brstion corrected mathematicany for dures for (and review the results cf physical decay;
- This incorperstica by reference provt.
spot. check measurements. The Ucer_:-
(11) Following replace'nent cf the ts.
sion wa.: approvad by the Actmr D:ree:or of ea shan determine that the quali!*"--
diation source or followtng reinstana.
the Feders! Reguter en Augus: 6. 1976.
y tion of the teletherapy unit in a ncg Copies are an11acle for msrect:en er etzt IOO*"OU. '
be obtamed from U.S. ?h:c!csr Regulatory (1) Is certified by the Amerie n Board of Radiology in The n=eur (iii) Fo'llowmg any repair of the te-Comrussion. Puel:e :. Met =*nt Roem.1717~
H Street.W Wies. sten. D.C. =555.
Radiological Physics. Radiolog:ca.
letherapy uzut that includes removal FIDERAL RICl$ tie. YCt. M, NO. 5 xCNDAY, JANUARY 8,1979
. Physics. Roentzen Ray and Os.nma.
ic) Records of the lleensee's evalua-Ray Physics. or ll:. ray and Radiums tion of the qualtfle<1 expert's training Physic::: or and exper:ence under i 35.04 shall be (b) Has the following8 minimtus preserved for five years after the training and expertence:
quali!!ed expert's last performance of (1) A Master's or Doctor's degree in a full calibration on the licensee's te-physics. biophysics. radiological phys-letherapy untt.
ics or health physim dec.161. Pub. L.83-703. 63 Stat. 948 (42 (2) One year of full time training in t'.S.C. ::ot t sec. :01. Pub. L 93-438, 88 therapeutic radiological physics: and 7.att.1:43 8 42 USC. 5841H (3) One year of full time expertence Dated at Washington.
D.C., this in a radiotherapy facility including personal calibration and spot check of 22th day of December.1973.
at les.st one teletherapy unit.
For the Nuclear Regulatory Corn-l 33.23 flecords.
4:ussion.
The licensee shall maintain, for in-Sass er:. J. CHILX.
spection by the Commission records Secretary of fAe Commisston.
of the measurements tests, corrective (FR Doc.79-532 Filed 1-5-79: 3:45am) actions, and instrument calibrations made under 1125.21-35.23 and records
,Ucensees.that have their teletherspy of the licensee's evaluation of the umts caEbrated by persons who do not meet quallfled expert's training and expert.
these entena for muumum trainme and ex-ence made under ! 35.24.
penence may request a treen.se amendment (a) Records of (1) full calibration excepting them from the recuirements of measurements under i 35.21 and <2) 135.04. The recuest, accomparued by the ap-UN""**
- "d*'*
I O I 3I 'I callbration of the instruments used to CFR Part 1"0) anould include the name of make these measurements under the proposed qualified expert a desenstion i 35.23. shall be preserved for five of h:s tramma and expenence including in-years after completion of the full call-formanon sim dar to that specified in bration.
135.:nb). reporu of at les.st one calibration tb) Records of (1) spot. check mes.
and spot-checac pregram ba. sed on measure-men.s personally cade by the preposed surements and corrective actions under i 35*"** and (2) calibration of in-
- '* ***" *h' I*'* 10 "*' u*a*ltficaticns encorsc=ent of the tecnnical q struments used to make spot check of the proposed expert from personal measurements under i 35.23, shall be knowiecge by a physte:.st certtited by the preserved for two years after comple.
Amencan Board of Radiology in cce of the tion of the spot check measurements spectablies 12.sted in 135.:Ca). The mdivid-and corrective actions.
cal's qualifications mil be evaluated by NRC's cor.sultamta in mer!ca.1 onystes. The amendment request sacu.1d be addreased to:
Ucense Mar.arement Eranch. UA Nucless Resistory C-~on. Waahmston. D.C.
23351 UNITED STATES f
NUCLEAR REGULArORY COMM8sstON
' WASHINGTON. O. C. 20sss POST AG E AMD F e ES P AID 4[]
u.s. nucLaAn accuuaTonY ar= sr/.
OFFICI AL. 8Us1 Ness c os.ene s ssson ags PENAL.TY FOR PRIVATE UsE. s2co
.a L
s i
(
-