ML19289E273
| ML19289E273 | |
| Person / Time | |
|---|---|
| Issue date: | 03/12/1979 |
| From: | Dircks W NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | |
| Shared Package | |
| ML19289E271 | List: |
| References | |
| RULE-PR-2, RULE-PR-30, RULE-PR-35 NUDOCS 7904110034 | |
| Download: ML19289E273 (6) | |
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9 UNITED STATES f *s g
NUCLEAR REGU!.ATORY COMMISSION 5 t. g...y '.I j
WASHINGTON, D. C. 20555 s,,.. /,/
MAR 1219f93-t Y.s
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TO ALL MEDICAL LICENSEES The attached order amends certain medical lice.nses to:
(a) Require the perfomance of molybdenum-99 breakthrough tests prior to administration of technetium-99m to patients.
(b) Prohibit the use of technetium-99n containing greater than specified levels of molybdenum-99.
(c) Require the establishment of written procedures and training for performing the tests.
(d) Require that certain records be kept.
Since this order becomes effective immediately, and its provisions must be implemented within 10 days after the date of this order, it is important that you transmit this information to cersonnel in your nuclear medicine facility as aulckly as possible and retain tnis order witn your license records.
4 William J. Dircks, Director Office of Nuclear Material Safety and Safeguards ENCLOSURE 4 o
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UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION OFFICE OF NUCLEAR MATERIALS, SAFETY, AND SAFEGUARDS WASHINGTON, D.C.
20555 ORDER MODIFYING LICENSES (EFFECTIVE IMMEDIATELY)
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- r m.5, A recent investigation revealed the possibility of greater than normal quantities of molybdenum-99 contamination in the technetium-99m from processes involving the elution or extraction of technetium-99m from molybdenum-99. The presence of the molybdenum-99 serves no' diagnostic purpose.
It could result in a radiation dose to a critical organ of one or more rems and should such doses occur in large populations of patients, they would be unacceptable from a public health and safety standpoint.
Approximately five to six thousand generators are shipped weekly presenting a potential for exposure of la.rge numbers of persons from contaminated technetium-99m.
There has been no' estimate made of the numbers of licensees using technetium-99m from other sources.
Tests for the presence of molybdenum-99 in technetium-99m for human use should be performed on each elution or extraction.
Information s
obtained during NRC inspections indicates that not all licensees routinely perform such tests.
There are no uniform requirements in licenses, regulations, or package labeling for the performance of tests to determine the amount of molybdenum-99 present in the technetium-99m prior to administration to patients.
The Nuclear Regulatory Commission (NRC) considers it necessary that, whenever feasible, steps be taken to minimize radiation exposure of patients and personnel.
Radiation exposures from abnormal levels of molybdenum-99 in technetium-99m for human use are unnecessary and preventable.
II From the foregoing, breakthrough tests
- as described belot are necessary to prevent unnecessary radiation exposures to patients and personnel as a result of the presence of molybdenum-99 in technetium-99m administered to patients.
Accordingly, the Director, Office of Nuclear
- In this context, the phrase " breakthrough test" refers to the detection and quantitation of molybdenum-99 in any separated technetium-99m, whether from a generator elution or other extraction process.
Materials, Safety and Safeguards has found pursuant to 10 CFR 2.204 of the' Commission's regulations that the public health, safety or interest requires that this Order be made effective immediately.
III In view of the foregoing and pursuant to the Atomic Energy Act of 1954, as amended, a'nd the regulations in 10 CFR Parts 2, 30, and 35, IT IS HEREBY ORDERED THAT:
Effective immediately, any license which authorizes possession and use of molybdenum-99/ technetium-99m generators and any license which authorizes extraction or separation of technetium-99m from molybdenum-99 not contained in generators is amended to add the following conditions:
(1) Beginning as soon as feasible but within ten (10) days of the date of this order, molybdenum-99 breakthrough tests shall be performed prior to the administration of technetium-99m to patients.
(2) Beginning as soon as feasible but within ten (10) days of the date of this order, technetium-99m containing more than one (1) microcurie of molybdenura-99 per millicurie of technetium-99m or more than five (5) microcuries of molybdenum-99 per dose of technetium-99m shall not be administered to patients. The limits for molybdenum-99 contamination represent maximum values and molybdenum-99 contamination should be kept as low as reasonably achievable belcw these limits.
(3) Beginning as soon as feasible but within ten (10) days of the date of this order, the licensee shall establish written procedures for personnel performing molybdenum-99 breakthrough tests including all necessary calculations and steps to be taken if quantities of molybdenum-99 in excess of the above specified linits are detected.
(4) Personnel performing molybdenum-99 breakthrough tests shall be given specific training in performing these tests prior to conducting such tests.
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- (5) The licensee shall maintain for inspection by the Nuclear Regulatory Commission records of t.e results of each molybdenum-99 breakthrough test performed and records of training given to personnel performing the molybdenum-g9 breakthrough tests.
(6) Recr-4 dev-bed in item (5) shall be maintained for two (2) year 1 performance of the tests.
IV Any licensee to whom this Order applies may, within 20 days from the receipt of this Order, request a hearing.
Any request for such hearing shall be filed with Mr. R. Cunningham, Director, Division of Fuel Cycle and Material Safety. U.S. Nuclear Regulatory Commission, Washington, D.C.
20555.
Such a request for a. hearing SHALL NOT STAY THIS ORDER.
V In the event a hearing is requested within the time specified, the issues to be considered at such a hearing shall be:
(1) Whether the circumstances described in section I above existed, and (2) Whether on the basis of such circumstances, this ORDER should be sustained as regards'the licensee.
FOR THE NUCLEAR REGULATORY COMMISSION 1
Will.iam J. Dircks, Director Office of Nuclear Material Safety and Safeguards Dated at Bethesda, Maryland B
thisfy day of March, 1979.
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NOTICES 14G37 Dated: March 5.1979.
ACTION: Not!ce of Intent, essary medical radiation exposure to patients by establishing appropriate
SUMMARY
- hhe Food and Drug Ad.
Net. son H. Caurnst!ANK.
criteria for the education and evalua.
Chairman. Federal Council ministration (FDA) plans to develop tion of competency of those who con-duct such procedures. Although volun-recommendations on voluntary nation-tary national standards have been de-
- d 3'I al standards for quallfications of medi-veloped by professional organizations.
cal radiation technologists. This notice not all medical radiation technologists
' [4110-03-M}
is being issued because the FDA be-meet those standards. and where State lieves it is necessary to have the public standards exist, there are inconsisten-Feed and Drug Administration participate in the process of develop. cies. Therefore, the agency proposes to develop recommended standards as CONSUMER PARTICIPATION ing the content and format of national "m dels" for use by teaching institu-oPen Meetin9 standards and guidance on effective tions certifying organizations, other p
ett such standards.
Fede aee and tates. These AOENCY: Food and Drug Administra-tion.
DATE: Comments by July 11.1979.
mented through educational programs and cooperative activities with profes-ACTION: Notice ADDRESS: Written comments to the sional organizations and State healtn
SUMMARY
- This document an-IIcaring Clerk (HFA-305). Food and agencies. Initial recommendations nounces a forthcoming consumer Ex-Drug Administration. Rm. 4-65. 5000 would address the qualifications of change Meeting to be chaired by the Fishers Lane. Rockville. MD 20857.
medical diagnostic x ray personnel.
Subsequent recommendations would Acting Food and Drug District Direc-FOR FURTHER INFORMATION address qualifications for radiation
-tor. Baltimore. MD*
CONTACT:
therapy and nuclear medicine tech-DATE: The meeting will be held at 10 no!Ogists.
a.m. Friday. March 30.1979.
Char!cs Froom. Bureau of Radiologi-These recommendations will be de-cal Health (HFX-4CO). Food and veloped by the FDA under the althoc-ADDRESS: The meeting will be held Drug Administration. Department of ity of section 356 of the Public Health at the Senior Citizen Service Center of Health. Education, and Welfare. Service Act, as amended by the Radi,
Tidewater.1210 Colonial Ave.. Mezzo 5600 Fishers Lane. Rockville. MD ation Control for Health and Safety Act of 19C8 (42 U.S.C. 263d) and sec-nine Floor. Norfolk, VA 23517.
20857.301-443-3426.
tions 301 and 311 of the Public Health FOR FURTHER INFORMA' TION Service Act (42 U.S.C. 241 and 243).
- CONTACT:
SUPPLEMENTARY INFORMATION: Section 356 of that act provides for Ninety percent of public exposure to the establishment and conduct of pro-E. Hope Frank, Consumer Affairs man made ionizing radiation results grams designed to protect the public Officer. New Federal Office Eldc* from medical procedures, primarily di.
health and safety from c!cctronic ltm.11-510, 7th and Marshall agnostic x ray euminations.The Food product radiation and authorizes Streets. Richmond, VA 23240. 804-and Drug Administration (FDA) recog. making recommendations where ap.
782-2748.
nizes that much medical benefit is de-propriate. Sections 301 and 311 of that d the broad respo ib ty to e
SUPPLEMENTkRY INFORMATION: rived from diagnostic x ray examina-jtjro The purpose of this meeting is to ex.
tions, radiation therapy, and nuclear tween the States on matters relating medicme procedure, but any radiation to protecting the public against speci.
change information between FDA offi-exposure may increase biological risk fled radiation hazards. The issuance of cials. consumers, and consumer repre-and any unnecessary exposure pre-this notice of intent is part of the FDA sentatives to present their views di-sents risk with no benefit. Regardless po!!cy of early public participation in rectly to the District Director of FDA* of equipment quality, medical radi. recommendation-development activi-by secking solutions to any problems ation technologists (tnose individuals, ties.
aereed on during this communication, other than !! ensed practitioners, who This notice of intent is also consist-and by giving the agency an opportu-conduct diagnostic medical x-ray ex-ent with a 1977 Public Health Service nity to discuss and communic' te vital aminations radiation therapy proce-Report. "CredentialinT Health Man-a health and policy issues to the con-dures, and nuc! car medicine examina-power." (HEW Publication No. (OS) cerned public.
tions) exercise considerable influence 77-50057). Recomniendation II of the over patient exposure. The actions of report states:
Dated: March 5.1979.
these technologists directly affect the Wrt.I.1A51 F. RANDOI.PH.
medical benefit as well as the radiolog.
National standards for the credentialing
'I **I*#d h'*I* h
- C"D** * "' 'h "I8 D* d**
Acting Associate Commissioner ical risk to the Dattent.
veloped and c:ntinuallt evaluated. Profes-An estimated 130.000 to 170.000 per, slonal organ!:ations, other elements in the private sector, and State goverrunents (FR Doc. 79-7253 Filed 3-12-79; 8:45 ami sons operate medial diagnostic x ray should play a strnificant role in this process, equipment in the United States. In ad-The stancards thus develo;:ed should be ut!-
dition, the medical radiation technolo-11wd for tne various purposes for which
[4110-03-M]
gist workforce has approximately standards are required, includm; profes.
[ Docket No. 78M-04t61 10.000 persons employed in nuclear sional certincat:on licensure, private sector NATIONAL STANDARDS FOR CUAt!HCAT;ONs medicine technolo;;y and 2.000 in the and cnit service employment, and third OF MEDICAL RADIATION TICHNCLOGISTS field of ionizing radiation therapy.
party reunbursernent.
Intent to Propose Recommendations The agency intends to develop rec-To assist in developing the recom-ommendations on national standards mendations the agency invitics com-AGENCY: Food and Drug Admm. istra' for medical radiation technologist ments and data supported by rational CIOR-qualifications to help minimize unnec-concerning the following questions:
FEDERAL RECliTIR VOL. 44, NO. 50--TUESDAY. MARCH 13,1979 ENCLOSURE 5
14b45
' NOTICES
'\\
- 1. What effect. and to what ertent,
- 13. Should the development of would model national standards for model national standards be expanded information and has concluded that-Qualifications of medical radition tech. to include qualifications for those 11-the petitioner meets the conditions for nolocists have on radiation exposure censed prr.ctioners (e.g., physicians, drug regulations. The agency has noti-exemption specified in the antibiotic of the patient? Please explain.
dentists, chiropractors. podiatrists, fled the petitioner by letter that the
- 2. Arc there effective alternatives to and osteopaths) who themscIves per-petition has been approved and is issu.
uniform national standards for qualifi. form or supervise others performing ing this notice in compliance with the
, cations (si medical radiation technolo, medical radiation procedurcs? Please regulations.
gist that can serve to promote the
'XPI3IU*
goals of:(a) improving performance of operators (both credentialed and non-Interested persons wishing to pro-EFFECTIVE DATE: March 13.1979.
vide information on these questions or. CONTACT:
FOR FURTHER INFORMATION credentialed) and (b) providing unt-other relevant topics for use in devel.
formity in standards (certification and ifcensure)? Please explain.
oping voluntary rccommendations on
- 3. Does the present voluntary cre. model national standards for quali!!ca-Nathan M. Kight. Bureau of Dructs tions of medical radiation technolo-(HFD-30). Food and Drug Adminis-dentiating system ensure that only ap.
gists may, on or before July 11. 1979, cation, and Welfare. 5600 Fishers tration. Depar' ment of Health Edu-propriately qualified operators per. send their written comments, views.
Lane, Rockville MD 20857, 301-443-form medical radiation procedures? and data to the Hearing Clerk (HFA-5220.
What evidence exists, either plo or 305), Food and Drug Adminic ration
- e con?
Rm. 4-65, 5600 Fishers Lane. Rock-SUPPLEMENTARY INFORMATION:
- 4. In those States that license tech. Ville. MD 2C857. Four copies of all Section 507(a) of the Federal Food.
nologists, have patient care and radi. comments should be submitted, except Drug, and Cosmetic Act (21 U.S.C.
atjon practices been improved over the that individuals may submit single 357(a)) requires batch certification of prelicensure conditions? What dn ts.
copies of conunents. Ccmments should all antibiotic drugs and any derivative exists, either pro or con? If patient I
thereof. To be certified. the drug must care and practices have improved, is ocket ru ber found brae c have the characteristics of identity, the improvement attributable to IIcen. the heading of this document. Com-strength, quality, and purity that have sure, or have other factors played a ments may be seen in the at:ove. been prescribed by regulation as neces-deciding role?
named office between 9 a.m. and 4 sary to ensure the safety and efficacy
- 5. What existing guide!!nes or stand-p.m., Monday through Friday. The of the drug. Under section 507(c) of ards could be considerated in develop-recommendstions that are drafted the act, the Commissioner may pro-ing uniform model national standarcs? after considering the comments wC! be mulgate regulations exempting an What exceptions or changes shoQld be proposed in the Frnr:ut RtorsTra. and antibiotic drug from certification if considered in any such existing guide, futher public comment will be invited. certification is not necessary to ensure This notice of intent is issued under safety and efficacy of use. The antibi.
lines or criteria?
otic drug regulations in f 433.1 (21
- 6. Should continued cempetency re.
the Public IIealth Service Act as CFR 433.1) establish procedures for quirements be considcred 'n model amended by the Radiation Control for obtaining exemption from batch certi-standards? If so, what criteria and Health and Safety Act of ICGS (sec.
fication of topical antibiotic drugs.
methods of competency assurance 356, C2 Stat. 1174-1176 (42 U.S.C.
On June 19, 1978, the Burroughs-should be considered 7
'263d)) and under authority dc!ccated Wc11come Co..
Research Triangle
- 7. Should the recommended model to the Commission (21 CFR 5.11.
\\
Park, NC. filed a pctition requesting standards include recognition for Datedt March 5,1979.
that Neosporin" Topical Ointment those indivic'uals currently performing as medical radiation technologhts.
WItuAM F. R&DotrH.
(bacitracin ploymyxin B. neomycin) be exempt from batch certification as e.g., a "grandfatnering" provision? If Mngeissociate Commissioner prescribed by i 448.510e (21 CFR so, what provisions should be consid-
/ rRegulat ry,t//cirs.
cred?
448.510e). A copy of the petition is on
- 8. What effect would model national fFR Doc. 79-%52 nled 3-12-79: 8M5 ami file at the office of the Hearing Clerk, standards have on the availability,
. Food and Drua Administratton, quality, and cost of medical radiation The Commissioner reviewed the data and Informaticn submitted as part of services if the standards were promu!. [4110-03-M]
the petition, as well as the certifica-gated by standard setting organiza.
tion history of the drug. Based on au.
tions? Picase explain.
- 9. What other factors should be con-Food and Drug Administration ac and um tM comons of s U33, sidered in developing model national (Docket No. 78P-01931 the Commissioner has conriuded that siandards ( e.g.,
the economy, job 8ACITRACINJCtYMYX!N 8.N!OMYCIN batch certification of bacitracin-poly.
hot myxin B neomycin topical ointment.
- orga'nizationsexisting standard setting necesan be likely to adept a Exemption Frem certification nd efficacy on the model national standard? To what ru
' extent?
AGENCY: Food and Drug Administra.
In accordance with section 50T(c) of
- 11. How could model national stand-tion.
the act and i 433.1(f). any antibiotic-ards be most effectively implemented? ACTION: Notice.
containing drug for human use Would.the benefits to t e accrued from exempted under 1433.1 is considered
SUMMARY
- The Commissioner of a national model outweich the cost in.
curred by standard. setting organiaa-Food and Drugs announces approval subject to section 505 of the act (21 U.S.C. 355). This action also con.sti-tions for administration of the recom-of a petition requesting that the anti-mended model standards?
blotic drug prcduct Ncosporin " Topi-tutes an approval of a new drug appli.
cation undcr 1314.1 (21 CFil 314.1) for
- 12. Should the proposed soluntary cal Ointment (bacitracin polymyxin D-the exempted antibiotic containing neomycin topical omtment) be drutt.
standards be written to include qualifi-cations for dental. ultra. sonic, and mi-exempted from the batch certification The Commissioner has determined crouate diathermy personnel?
requirements for antibiotte dtnes. The that* this document does not contain Conunissioner has retiewed pcrtinent an agency action co cred by { 25.1(b) f tDERAL REG 1511R, VOL 44, NO. 53--futSDAY, MARCH 13,1979 e