ML20199C028
| ML20199C028 | |
| Person / Time | |
|---|---|
| Issue date: | 10/23/1997 |
| From: | Mcgaffigan E NRC COMMISSION (OCM) |
| To: | Hoyle J NRC OFFICE OF THE SECRETARY (SECY) |
| Shared Package | |
| ML20199B989 | List: |
| References | |
| FRN-62FR63634 AF70-2-011, AF70-2-11, SECY-97-232-C, NUDOCS 9711190191 | |
| Download: ML20199C028 (24) | |
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A F F I R ~M., A T I O N V O T E RESPONSE SHEET TO: - John C. Hoyle, Secretary FROM: COMMISSIONER MCGAFFIGAN
SUBJECT:
SECY-97-232 - FINAL RULE ON EXEMPT DISTRIBUTION AND USE OF A RADIOACTIVE DRUG CONTAINING ONE MICROCURIE OF CARBON 14 UREA;(PARTS 30 AND 32)
' Approved % Disapproved Abstain Not Participating . Request Discussion COMMENTS:
See attached comments and edited pages.
m
$ 1*c M Mjj08 CMRESPONDENCE PM SIGNATIJRE ((l() (
Release Vote / < / lo 13' f17 DATE' Withhol'd Vote / /
Entered on "AS" Yes x No r -n- , ,
Commissioner McGaffican's comments on SECY-97-232:
I approve publication of the final rule to amend Parts 30 and 32 to permit the exempt distribution and use of cart >on-14 capsules for human use as described by the staff.
I commend the staff for expeditiously developing the final rule after review of public comments received on the proposed rule and offer the following comments for the staff's consideretion.
- 1) The rudiation risk associated with the diagnostic use of the carbon-14 capsules should be consistently characterized as " insignificant." Edits to achieve this purpose are indicated on the attached pages.
- 2) The Health and Safety Effects section of the Regulatory Analysis should be revised to clarify that individual and collective dose estimates do not consider the radiation dose received by the patient, and that the collective dose of 5 person-rem over a 50 year period discussed in phragraph 4 is not an annual dose (suggested edits are attached).
- 3) Other edits for clarification and consistency are indicated on the at+ ached pages.
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[7590-01-P] . ;
NUCLEAR REGULATORY COMMISSION - l
-1 10 CFR Parts 30 and 32 RIN: 3150-AF70 Exempt Detribution of a Radioactive Drug Containing One Microcurie of Carbon-14 Ursa AGENCY: Nuclear Regulatory Commission.
s ACTlON: Final rule.
SUMMARY
- The Nuclear Regulatory Commission (NRC) is amending its regulatons to permit NRC licensees to distribute a radioactive drug containing one microcurie of carbon-14 uros to any person for "in vivo" diagnostic use, The NRC has determined that the radioactive an lai n:Fccut component of suc'h a drug in capsule form presents radiation risk and, therefore, X regulatory control of the drug for radiation safety is not necessary, This aniendment makes the R
drug more widely available and reduces costs to patsents, insurers, and the health care industry. This action grants a petition for rulemaking (PRM-3512) from Tri-Med Specialties, l
} Inc. and completes action on the petition.
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c EFFECTIVE DATE: (30 days from'date of pubhcation in the Federal Register).
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and provides a comparable allemative to the C-14 test. The apparent assumption underlying the environmental assessment is that in the absence of the C-14 test, the only altemative for the detection of H. pylori is invasive c:-M-:+:epy.
Response: Because the C-14 usea capsules are already available to authorized user -
. physicians, the only regulatory issue _in this rulemaking is whether the C-14 method should be made available to individuals who are not authorized users. The purpose of the environmental assessment is to consider and document whetner the subject rule ic expected to have any a
significant impact to the environment. In this environment assessment, the NRC has~
determined that the environmental impact is expected to be insignificant because of the -
extremely low radiological hazards associated with the use of capsules containing one microcurie C-14 urea. The presence of an additional non-invasive altomative procedu does not affect NRC's determination of no significant environmental impact.
j comment 10: NRC's policy in the past has been not to exempt byproduct material that is ingested. Any changs in this policy would be a significant departure from existing NRC l regulations.
! Response This change is a departure from existing NRC regulations, in the statement i
of consideration for the proposea rule, under the heading "Curmnt NRC Regulations on Exemptions From Licensing," the NRC stated that, aithough two broad material exemptions
($ 30.14, " Exempt concentrations," and $ 30.18, " Exempt quantities") exclude the transfer of byproduct material contained in any product designed for ingestion or inhalation by a human -
being, the C-14 capsules manufactured or prepared as a radioacave drug can be distributed to persons exerr.pt from licensing for 'in vivo' diagnostic use because tne capsules present an insignificant radiological risk to the public and the environment. This exemption only a@ lies to 9
capsules may be disposed of by users as ordinary trash. Paragraph (a)(6) of 9 32.21 requires that applicants submit copies of prototype labels and brochures for NRC approval. The NRC will ensure that the labels meet the requirements of 6 32,21a before they are approved. Since paragraph (a) of S 32.21a specifies that the . 'V must be duraole and legible, the use of an additional phrase such as conspicuously and prominently"is unnecessary. Promotional w ue. seh v u e ed A' brochures are for information only, chN o " giovent manufacure #em~indic ifwfon the X promotional brochures that C-14 is a radioactive material.
Ill. Summary of the Final Amendments Final Amendment to 10 CFR Part 32 The regulations in 10 CFR Part 32 are amended to add new @@ 32.21 and 32.21a, to provide requirements for a specific license to manufacture, prepare, process, produce, package, repackage, or transfer for commercial distribution, capsules containing one microcurie of C-14 urea, as a radioactive drug, to be distributed to any persen for "in vivo" diagnostic use.
! These requirements are consistent with the existing requirements on other items under the heading " Exemptions"in 10 CFR Part 30. The arnendment includes a reminder that licensees distributing the radioactive drug to persons exempt from iscensing would not be relieved from other applicable Federal (e.g., FDA) or State requirements goveming the manufacture and distribution of drugs. .
The amendment requitas that the manufacture or preparation of capsules containing one microcurie of C-14 urea be prepared by persons who meet the current NRC regulations to manufacture and commercially distribute radioactive drugs. The NRC believes reguiatory 12 i
control is needed to provide high confidence that the drug contains one microcurie of C-14 urea and does not contain any other radioactive contaminants.
Final.%mendment to 10 CFR Part 30 e Inc. d d K The NRC has determined that the drug in capsule form presents r,c c@r c,,#
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radiological safety [ environmental risk, and that it is not necessary to regulate the use of this drug for its radioactive component. Therefore, the NRC can not justify requiring physicians, or any other person, to meet NRC training and experience criteria directed at the safe use of radicactive drugs, or to become an " authorized user." Hence, the capsules can be distributed to any person. However, other Federal or State agencies may limit the receipt and use of the capsules in accordance with their own requirements.
The regulations in 10 CFR Part 30 are amended to add a new $ 30.21, to permit any person to receive, possess, use, transfer, own, or acquire for "in vivo" diagnostic use, capsules containing one microcurie of C-14 urea without a license. The final regulation includes a reminder that persons receiving the capsules would not be relieved from other Federal or State law govem:ng drugs. Further, in accordance with the NRC's provisions for research involving human subjects (10 CFR 35.6), the exemption permitting receipt and use of the capsules for "in vivo" diagnostic use does not extend to use of the capsules for research involving human subjects. Any person desiring to use the capsules for human research would still be required to submit an application for a specific license under Part 35. The phrase "in vivo diagnostic use" was selected to describe the activity authorized in $30.21 to differentiate it from the term
" medical use" because:
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s-(1)l
- Medica!_use" limits administration to authorized users; use of this drug would not be so limited; and
'(2)
- Medical use" includes the administration of the drug to a human research subject, _ .i d- which would M peht?.:1 by P.!: m!;;ad:ing.- -
h 6 % h re ir o A spe d < \bense g#f W 4 bM R mk % t.1 e ;
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Effects of the Final Amendments The final amendments make the drug available to any person, for "in vivo" diagnostic
. use, without need for an NRC or Agreement State license; Because tne receipt and use of the -
Ldrug are exempt from NRC licensing, Agreement States need to trake appropriate provisions in
. their regulations to recognize the exempt distribution of the drug, for "in vivo" diagnostic use.
i Thus, after the manufacture and distribution pf the dru e NRC and the Agreement States g will not regulate the use of the dru0.as long aa its use is for "in vivo" diagnostic use. This means that, under NRC and Agreement State regulations, primary-care physicians do not need to be ' authorized users' in order to administer the drug, and do not need to refer their patients to r.uclear medicine physicians. This chould result in cost savings to patients. Other Federa!
I and State organizatiors with responsibilities for regulating drugs w!!i determhe and regulate who can receive and use the drug for "in vivo" diagnostic use. NRC wl!! continue to regulate the use of the drug for research involving human subjects under a specific Fart 35 license.
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- distribution, capsules centaining one microcurie carbon-14 urea each for "in vivo" diagnostic use, to pehsons exempt from licensing.
. Paraorboh (a)(1)
This paragraph limits issuance of an " exempt distribution license" for distribution of the capsules to persons exempt from licensing to only those who possess either a NRC or-Agreement State " specific license" for pc : assion and use of byproduct material.
Parmaraoh (a)(21.
To assure that the capsules contain one microcurie of carbon-14 and present no other radiological nsks, this paragraph requires that the persons manufacturing and/or commercially distributing the capsules for "in vivo" diagnostic use must also meet the requirements of S 32,72(a)(2). Specifically, these persons must be:
(1) Registered with or licensed by the FDA as a drug manufacturer, or (2) Registered with or licensed by a state agency as a drug manufacturer; or (3) Licensed as a pharmacy by a State Board of Pharmacy; or.
(4) Operating as a nucler r pharmacy within a Federal medi;al institution.
Parnaraoh (a)(3)
- This paragraph requires applicants to provide evidence that each carbon-14 urea capsule contains one microcurie. The NRC's evaluation that the capsules wauld sult in 5
- risignificant radiation risks was basad on the capsules containing one microcurie of carbon-14 4 .
urea.- Therefore, applicants must demonstrate that the activity of each carbon-14 caosule t
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- requirements for the manufacture and commercial distribution of carbon-14 urea capsules to -
persons exempt from licensing and establishes regulations to permit any person to receive the capsules with'out an NRC license. The Commission believes that the radioactive component of an A.
)C this drug presents 1gF significant radiation riskand, therefore, mgulatory control of the "in vivo" diagnostic use of the capsules for radiation safety is not necessary, it is expected that this final rule will not cause any significant !ncrease in radiation exposure to the public or radiation
. release to the envNnment beyond the cxposures or releases resu y,g from the use of the carbon 14 capsules under the current regulations. Also, it is expected that the e will be no non-radiologicalimpacts.- One public comment on the draft environmental assessment has been received (See Comment 9 under the heading " Proposed Rule, Public Comments, and NRC Responses").
The environmentel assessment and finding of no significant impact on which this determination is based is available for inspection at the NRC Public Document Room,2120 L Street NW. (Lower Level), Washington, DC. Single copies of the environmental 3ssessment and the finding of no significant impact are available from Dr. Anthony N. Tse, Office of Nuclear I Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, tele .one (301) 415-6233 or e-mail at ANT @nrc. gov.
l Vll. Paperwork Reduction Act Statement This final rule amends information collection requirements that are subject to the L:
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). These requirements were approved by the Office of Management and Budget, approval numbers 3150-0001,3150-0017, and 3150-0120.
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1.4 hDD91gd Rule and Public Comments The proposed rule was published in the Eederal Reoister (62 FR 32552, June 16,1957) for a 30-day public comment period. The NRC received seven public comment letters. Four commenters supported the rule, one opposed the rule, and two provided comments without explicitly stating whether they support or oppose the ru',e. A summary of public comments and NRC's responses are presented in the preamUe of the Federal Register notice. Except a minor change in wording, the final amendments are the same as the proposed arrendments. No comments related to the draft Regulatory Guide has been received.
- 2. Obiective l
The objective of the rulemaking is to amend 10 CFR Part 32 to permit the manufacture and commercial distribution of "C-urea capsules to any person (including physicians who are not
" authorized users' under Part 35) and to amend 10 CFR Part 30 to permit any person, without an NRC license, to receive and use the capsules for in vivo diagnostic use for humans.
- 3. Altematives 1
Three attematives have been considered in the regulatory analysis: deny the petition,ie.,
maintain the status quo, permit the distribution of the capsules to persons exempt from licensing, and permit the distribution of the capsules to general licensees.
Under the first attemative, only physicians who are authorized users undar Part 35 would be allowed to possess and administer the "C-urea test. Any physician could apply to becomo an l authorized user. However, the NRC expects few physicians would apply for a Part 35 license i for the sole purpose of using the capsules because of the requirement for training and experience and the associated costs of obtaining and maintaining a Part 35 license.
Attemativoly, physicians who are not authorized users can continue to refer their pa+.ients to physicians who are authorized users to undergo the diagnostic test. However this would not relieve the current expense, inconvenience, and delay encountered in an otherwise straight-forward procedure.
Under the second attemative,10 CFR Parts 32 and 30 would be amended.10 CFR Part 32 would be amended to permit the manufacture and commercial distribution of "C-urea capsubs to any person (including physicians who are not " authorized users" under Part 35); 10 CFR Part 30 would be amended to permit the manufacture and commercial distributio1 of the capsules to any person, for in vivo diagnostic use for humans. The NRC has determined that the radioactive component of this drug presentsemme diation risk and, therefore, regulatory control of the capsules is not necessary. ,,y,. 4y Urider the third attemative,10 CFR Part 35 would be amended to permit any physician to receive and use the capsules under a general license. The health and safety concems for this attemative are the same as the Altemative 2. However, if this attemative were adopted, there could be a burden to those Agreement States that normally require registration of general 3
a Scenario Maximum Exposed Routine Exposure Individual Worker administering "C. Full-time worker,8,000 Less than 0.7 mremlyr urea brer'.h tests patients /yr Routine exposure of patier,ts Patient tests negative 0.38 mrem / capsule from "C-urea broath tests Patient tests positive 0.18 mrem / capsule Reicase of 150 pCi of "CO, Member of public la the Less than 0.0002 mrem inte administration administration area fact.,ty from fire Ruptura of a capsule Skin (100 cm 2) exposed for 5.8 mrad skin dose, causing skin contamin- one hour prior to washing; 0.029 mrem (CEDE) j ation of worker or patient 0.075 pCi' skin absorption l l
Furthenitore, the NRC concluded that the impacts associated with any releases of "C to the 1
surrounding environment are expected to be very small and the expected risks are minimal.
The earth's atmosphere contains an inventory of naturally occurring "C of about 3.8 million curies (equivalent to the activity in 3.8 trillion breeth tests), which is in addition w the huge inventory of about 240 million curies in the world's oceans. The "C released into the atmr' sphere from the use of this test v.'ould aix with the global inventory and expose the public and other bivec components of the environment to "C intakes from inhalation, drinking water, and all possible food pathways in the same manner as naturtily occurring "C. The current world inventory of naturally occurring "C results in an average dose to the public of about 1.25 mremlyear, and the release of 0.6 curies of "C from the total of 600,000 tests assumed to 4
be administered annually would result in an additional average annual dose of 2 X 10 mrem.
This is far below the EPA reporting level of 1,m[em/ year required under the Clean Air Act for x
routine exposures to a member of the public,.ethe 4 mrem / year EPA limit for public drinking water. In a total population of about 260 milton people in the U.S., the collective annual dose from the breath tests would be about 0.051 person-rem. In addition, the doses from normal use of breath tests, or f om any accidental release of "C to the environment also are expected to be very small because the concentration of CO, released is very low and it would mix immediately with the atmosphere. W oM encue /r pwds u
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The small doses from naturally occurring "C are of little significance to human health and the environment. Potentiallong-term impacts from widespread releases of the long-lived "C (5,730-year radiole.gical half-life) from breath tests were concluded to be insignificant.
Assuming that the testing in the U.S. would increase over a period of time to an average of a million tests per year for 50 yearsg the collective annuaIdose to the U.S. population would be x about 5 person-rem over the ned 50 yea This dose is very small when compared to the 3 annual ::ollective dose to the U.S. populati from naturally occur-ing "C of over 300,000 peiton-rem, and about 78,000,000 person- m from a'l naturally occurring radiation. Clearly, 1
an increase of a few person-rem will not si ificantly change these exposures, and thus there is no expected impact from the widespres - .e of the breath test on the entire U.S. population, h.a .
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As a result of this analysis, the NRC concludes that Altematives 2 aad 3 are clea ly preferable to the no action attemative. This is because either of the two attematives will result in significant cost savings with no measurable adverse efiect on health and safety. Furthermore, the NRC's recommanded option is Attemative 2 because i; would avoid the unnecessary cost burden to some Agreement States and their generallicensees.
Therefore, by promulgating the final rule, the cost savings would be maximized without any measurable adverso effect on public health and safety.
- 5. Qtcis'en Rationale Based on the above analysis, the NRC is amending its regulations to permit the manufacture and commercial distribution of Carbon-14 urea capsules to any person (including physicians who are not " authorized users" under Part 35) and permit any person, without an NRC license, to receive and use the capsules for in vivo diagnostic use for humans t>ecause the radiological risk from such distribution would be r4@@As and the savings to patients could be significant.
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T Environmental Assessment For Final Amendments to 10 CFR Parts 30 and 32
" Distribution of a Radioactive Drug Containing One Microcurie of Carbon-14 Urea as Exempt Material for "In Vivo" Diagnostic Testing" Statement of the Final Action The Nuclear Regulatory Commission (NRC) is amending its regulations to allow NRC licensees to distribute a radioactive drug con +sining one microcurie of carbon-14 urea to any person for "in vivo" diagnostic us . The NRC has determined that the radioactive component of an ;ni,v. en&
such capsules presents eenim adiation risk and, therefore, regulatory con'rol of the drug for K radiation safety is not necessary. This amendment mees the drug more widely available, thus reducing costs to patients, insurers, and the heaMi care industry. This action is being taken in response to a petition for rulemaking (PRtMS-12) submMec by Tri-Med Specialties, Inc.
Need for the Amendments The amendments have been developed to grant the petition for rulemaking. The final rule permits manufacturers or commercial distributons to distribute carbon-14 urea capsules as exempt materi9l to any person. The Commission is promulgating this rulemaking because it sns;f,%g believes that ti.e radiological risk from such distribution would be ecy@bicand tiie savings to )c patients could be significant. In addition, the Commission recognizes that other Federal and State agencies Ie.g., Food and Drug Administration and the State Boards of Pharmacy) are responsible for the receipt and use of drugs that do not contain byproduct materials, and would provide necessary oversight for the safe use of these carbon-14 urea capsules as drugs.
Alternatives Considered Three attematives have been considered regarding the petition: deny the petition, i.e.,
maintain the status quo, permit the distribution of the capsules as exempt material, and permit the distribution of the capsules to generallicensees.
Under the first attemative, the current situation would continue: only physicians who are autholized users under Part 35 would be allowed to possess and administer the C-14 urea test.
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1 Any physician could apply to become an authorized user, However, the NRC expects few physicians would apply for a Part 35 license for the sole purpose of using such capsules because of the requirement for training and experience and the associated ctsh of obtaining and maintaining a Part 35 license. Altematively, physicians who are not authorized users can continue to refsr their patients to physicians who are authoried users to undergo the diagnostic test However this would not relieve the current expense, inconvenience, and delay encountered in an otherwise straight-forward procedure.
Under the second attemative,10 CFR Parts 32 and 30 would de amended. Part 32 would be amended to establish requirements for the manufacture and distribution of C-14 urea rqsules to persons exempt from licensing, i.e., any person (including physicians who are not
" authorized users" under Part 35); Part 30 would be amended to ;.ermit any person to receive, possess, use, transfer, own, or acquire the capsules for in vivo diagnostic use for humans without a li, cense The NRC has determined that the radioactive component of this drug g presenIMma diation risk and, therefore, regulatory control of the capsules is not necessary.
Under the third altemative,10 CFR Part 35 would be amended to permit any ohysician to receive and use the capsules under a generallicense. The herith and safety concems for this attemative are the same as the Attemative 2. However,if this altemative were adopted, there 4
could be a burden to those Agreement States that normally require registration of general license holders. An additional burden could also be imposed on general licensees located in the Agreement State if the State charges a license or registration fee.
Based on the Draft Regulatory Analysis prepared for this proposed rule,'5e Commission concludes that Altematives 2 and 3 are clearly preferable to the no action altemative. This is because either of the two attematives will result in significant cost savings with no measurable adverse effect on health and safety. Furthermore, the NRC's recommended option is Attemative 2 Decause it avoids the unnecessary cost burden to some Agreement States and their licensees.
Imoact on the Puolic and the Environment ,
The amendments are expected to have n(significant impact on the public and the K
environment. The NRC assumes that the same number of breath tests will oe administered regardless of the level of NRC regulatory control. This view is predicated on the belief that 2
each physician's pnmary motivation is to provide the best possible care to his or her patients, if the breath test is judged preferable to endoscopy, or other procedure, any physician not authorized to use the test will refer his or her patient to authorized users who could perform the test under existing NRC regulations. Under this assumption, this rulemaking action is expered to result in no change in radiatio') exposures to the workers and patients when compared with the status quo. Similarly, it is expected that there will be no change in impact to the environment because the Commission assumes that the same number of tests will be administered regardless of which attemative is adopted.
The earth's etmosphere contains an inventory d naturally occurring C-14 of about 3.8 million curies which is in addition to the huge inventory of about 240 million curies in the world's oceans. The smali amount of C-14 released into the atmosphere from the use of this test would mix with the global inventory and would have no impact on public health. The current world inventory of naturally occurring C-14 results in an average dose to the public of about 1.25 mrem per year, and the release of 0.6 curies of C-14 from the total of 600.000 tests assumed to be administered annually would result in an additional average annual dose of i A 2 X 10 4 mrem. %s N kr b d u ,; e v EPA repr G
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List of Aaencies and Persons Consulted and Identification of Sources Used Followirig the receipt of the petition for rulemaking, a " Notice of receipt of petition for rulemaking" was published for public comment in the Federal Reaister on December 2,1994, (59 FR 61831). A total of 315 public comment letters,313 supporting (mostly form letters) and 2 opposing letteis, were received. This petition was discussed with NRC's Advisory Committee on the Medical Uses of isotopes ACMUI) at the October 1995 meeting. Furthermore, the draft rulemaking pian was forwarded to 29 Agreement States for comments.
A proposed rule was published in the Federal Reaistu (62 FR 32552, June 16,1997) for a 30-day public comment period. The NRC received seven public ccmraent letters. Four commenters supported the rule, one opposed the rule, and two provided comments without explicitly stating support of or opposition to the rule. A summary of public comments and NRC's responses are presented in the preamble of the Federal Register notice. Except a minor change in wording, the final amendments are the same as the proposed amendments.
One commenter addressed the draft environmental Assessment. The commenter stated that the environmental Assessment fails to consider the fact that another equally non-invasive, 3
but non-radiological, diagnostic procedure (such as C-13 test) is available and provides a comparabh attemative to the C-14 test: The commenter apparently concluded that the assumptiori underlying the environmental assessment is that in the absence of the C-14 test, the only attemative for the detection of H. pylori is invasive gastroendoscopy.
The-purpose of the environrnental assessment is to address and docuraent the expected impact to the environment of subject rule. As presented in the regulatory analysis prepared for this rule, the NRC has determined tnat the environmental impact is expected to be insignificant becaut.e of the extremeY low radiological hezards associated with the use of capsules containing one mictocurie C-14 urea.
If the environmentalimpact had been significant, then the existence of a non-radioactive attemative would have been a factor iri assessing the cost-benefit of this rulemaking. However, the impact is not significant. Hence, thc regulatory issue in this rulemaking is whether the C-14 method should be made available to physicians who are not authorized users, and not whether there exists a non-radioactive attemative.
Findino of__No Sionificant Imoacts ,
The Commission has determined under the National Environmental Policy Act of 1969, as amended, arid the Commission's regulations in Subpart A of 10 CFR Part 51, that the amendments will not be a major Federal action significantly affecting the quality of the human environment, and therefore an environmentalimpact statement is not required. The final rule amends 10 CFR Part 32 to permit the manufacture and commercial distribution of C-14 urea capsules to any person (including physicians who are not " authorized users" under Part 35) and to amend 10 CFR Part 30 to permit any person, without an NRC license, to receive and use the capsules for in vivo diagnostic use for humans. The Commission believes that the radioactive e is ~
n'. 2.4 X component of this drug presents radiation risk and, themfore, regulatory control of the capsules for "in vivo" diagnostic use is not necessary. It is expected that this final rule will not cause any significant increase in radiation exposure to the public or radiation release to the environment beyond the exposures er releases resulting from the use of the carbon-14 capsules under the current regulations.
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hett a U N STATES l."0- I'; NUCLEAR REGULATORY COMMISSION .
WASHWeToN D.C. seges.4em l l
- The Honorable Dan Schaefer, Chairman Subcommittee co Energy and Power Committee on C.smmerce
- lduku.1 g g g %g uW, 5M United Sta,tes f souse of Reprei,entatives Washington, DC 20515
Dear Mr. Chairman:
Enclosed for the information of the Subcommittee are copies of a pubhc announcement and a Federal Register notice concoming a final amend.mnt to 10 CFR Parts 30 and 32. This
. rulemaking is being taken in response to a petition for rulemaking submitted by Tri-Med Specialties, Inc. . , in an ineg...Ecut The Nuclear Regulatory Commission (NRC)is ar snding regulations to allow NRC licensees-to distribute a radioactive drug containing one microcu ' of carbon-14 uros to any person for"in vivo" diagnostic use. The purpose of this diagnostic te is to detect the presence of the bacterium He!icobacter pylat (H. pylori), a cause of pe 'c ulcers. The NRC has determined that the radioactive component of such capsulet presents diation risk and, therefore,-
regulatory centrol of the drug for radiation safety is not necessary. Tha manufacture and distribution of the capsules wii continue to require an NRC license. This amendment makes the drug more widely availabla, thus reduces costs to patients, insurers, and the health care industry.
Sincerely, Dennis K. Rathbun, Director Omes of Congressional Affairs
Enclosures:
- 1. Public Announcement
- 2. FederalRegisterNotice c Representative Ralph Hall
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- r J Draft press release'-' 9/3/97 1 ' y. '
NRC CHANGES REGULATIONS TO PERMITc EXEMPT DISTRIBUTION OF RADIDACTIVE DIAGNOSTIC DRUG
- The Nuclear Regulatory Commission is amending its regulations to allow a specific radioactive drug used to diagnose stomach ulcers to be distributed to any
. person for administration to humans. Before this change, only physicians authorized by the NRC or Agreement States could receive and administer the drug.- .
i The @ange does ilot relieve persons from the requirement to comply with applicable Food and Drug Administration or other Federal and State requirements governing receipt, administration and use of drugs.
The change is in resporise to a 1994 petition for rulemaking from Tri-Med -
Specialties, Inc. - The revised regulation allows any person to receive, possess, use and transfer capsules containing one microcurie carbon-14 urea each for 1 . ;
diagnostic use in patients. The NRC has determined that the capsules present# X 4
% 6.;,,p%9 CQ d asshc ce cf N radiation risk, and therefore believes that regulatory control of he rug for
-i x.
iudiation safety is not necessary.
I Under the amendments, manufacturers of the capsules and commercial
. pharmacies that prepare the capsules will continue to need an NRC license to provide high confidence of capsule contents. The containers of the capsules must 2 bear the words " radioactive material" and other specific information on the contents of the container. In addition, only those persons who are licensed will be F A ; permitted to 'use the capsules for research involving human subjects.
The Trl Med petition stated that Carbon-14 t,rea can be used to detect the presence of a bacterium that cat.ses peptic ulcers, a chronic inflammatory condition of the stomach and duodenum that affects as many as 10 percent of 1 __ . _ . _ _ - _ __ _ _ _ _ - . - _ _.
'.i-people in the United States at some time in their lives. According to a July 1994 article in the Journal of the American Medical Association, the disease has 4
relatively low mortality, but results in substantial human suffering and h!gh economic costs. Doctors can'now cure most ulcer problems'with antibiotics. -The test usingrbon-14 urea is non-invasive. A doctor asks the patient to swallow the capsule with water.- After 15 minutes the patient blows into a collection bag, r
- which is mailed to a testing laboratory for analysis. -
Before the change, only physicians who wars authorized users (e.g.,
physicians who met certain training and experience criteria regarding the safe use -i f
'of radioactive drugs) or persons working under the supervision of an authorized user could administer radioactive drugs for. medical purposes.
Under the amendments, physicians or other health care workers will not need to be authorized users in order to administer the drug, and physicians will not I
need to refer their patients to nuclear medicine physiciaris. This should result in cost savings to patients, insurers, and the health care industry.
A proposed rule on this subject was published in the Federal Register for public comment on June 16. Minor changes made to the rule as a result of L comments received are discussed in a Federal Register notice that will be published shortly.
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h,f UNITED STATES .
. NUCLE AR F.E00LATORY COMMIS$lON 3G -* wasamoton,on rossscoot _
IN RESPOhSL,-PLEASE:
November '5, E 1997_ - REFER.TO: M971105B 6 ,,,-
$ECRETARY I
' MEMORANDUM FOR: L. Josepn Callan _
Exe iv iDirecto -for Operations Jo ; d,. 1 , aec ary k-FROM:
SUBJECT:
-ST- F REQUIREMENTS - AFFIRMATION SESSIO ,
11:30 A.M.,-AND 3:00 P.M., WEDNESDAY, POVEMBER 5, 1997, COMMISSIONERS' CONFERENCE ROOM, ONE WHITE FLINT NORTH, ROCKVILLE, MARYLAND-(OPEN.TO PUBLIC ATTENDANCE) 9 tb 11:30 A.M. Session
~
L. SECY-97-232___ Final Rule on' Exempt Distribution and Use of_f Radiq3ctivc Dv3.la Conta_inina Ona Microcurie of Carbon 14 Urea (Parts-30 and 32).
-The Commission approved a final' rule amending 10 CFR Parts 30 and 32-to permit-the exempt distribution and use of capsules containing one microcurie carbon'-14 urea for "in vivo" diagnostic use. The staff should incorporate the following comments and the editorial changes provide.d in the attachment. ,
The staff response to comment 3 chould be reviewed and revised by a staff Health Physicist with expertise in radiological assesements to ensure it accurately and clearly responds to the Comment.
The Health and Safety Effects-cection of the Regulatory Analysis should be-revised to clarify that individual and collective dose estimates do not consider the-radiation dose received by the patient, and that the collective dose of 5 person-rem.over a 50 year period discussed 7.n paragraph 4 is not an annual dose.
Following incorporation of-these. comments and the editorial changes provided in the attachment, the. Federal Recister notice
,should be reviewed by the Rules-Review and Directives Branch in the Office of Administration and forwarded to-the Office of the Secretary for. signature and publication.
(EDO) (SECY Suspense: 12/5/97) m . ' " ~ - ~ , , , , ,,
a R. 3:00 P.M. Session
- Lu - SECY-97-228 - Final Amendments to 10 CFR_Part 73. " Chances to Nuclear Power Plant Security Recairements" The Commission approved a final rule amending 10 CFR Part 73 to
' change certain physical security requirements associated with an internal threat. The staff should coordinate the finalization of the public announcement with the Office of Public Affairs and issue a press release related to this rulemaking.
Following incorporation of the editorial chsnges provided in the attachment, the Federal neaister notice should be reviewed by the Rules Review and Directives Branch in the Office of Administration and forwarded to the Office of the Secretary for signature and publication.
(EDO) (SECY Suspense: 12/5/97)
Attachments:
As stated cc: Chairman Jackson Commissioner Dicus Commissioner Diaz Commissioner McGaffigan EDO OGC CIO CFO OCAA OCA OIG
! Office Directors, Regions, ACRS, ACNW, ASLAP (via E-Mail) l PDR - Advance DCS - P1-17 i
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- l. Editorial Changes to the Final Rule in SECY-97-232 l Changes to the Federal keaister 140tice
- 1. On page 1,line 4, replace 'a minimal' with 'an insignificant.'
- 2. On page 9, paragraph 2. line 8, delete the 's' on
' procedures.'
- 3. On page 12, paragraph 1, line 6, delete 'nothing will prevent' and insert 'are not required to' after
' manuf acturers . ' Also, delete 'from' and replace
' indicating' with ' indicate. '
- 4. On page 13, paragraph 2, line 1, replace 'no significant' wita 'an insignificant.' In line 2, replace 'or' with
'and.'
- 5. On page 14, item (2), line 2, replace 'he prohibited b;' this rulemaking* with ' continue to require a specific license pursuant to Part 35 under this rulemaking.'
- 6. On page 14, last paragraph, line 5, delete the comma.
- 7. On page 16, last paragraph, line 2, delete 'c.ot' and in line 3, replace 'significant' with
- insignificant.'
- 8. On pago 22, paragraph 1, line 4, replace 'no significant' with 'an insignificant.'
Changes to the Regulatory Analysis
- 1. On page 3, paragraph 5, line 6, replace 'a minimal' with 'an insignificant.'
- 2. On page 7, first full paragraph, line 13, replace ' or' with
'and.' Als<., add at the end of the paragraph: The routine exposure of patients was not considered when calculating the inuividual or collective doses resulting from the diagnostic tests.
- 3. On page 7, last paragraph, line 5, delete ' annual' and in line 6, delete 'next.' Also in line 6, delete the 's' on
' years' and insert ' period' af ter 'yeer. '
- 4. On page 8, last paragraph, last line, replace ' negligible' 5 with ' insignificant.'
Changes to the Environmental .ssessment
- 1. On pag' paragraph 1, line 4, replace 'a minimal' wich 'an inn i r tcant.'
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On page 1, paragraph 2, line 4, repitee ' negligible' with 2.
' insignificant.'
- 3. On page 2, paragraph 2, line 7, replace 'a minimal' with 'an insignificant.'
- 4. On page 2, laut paragraph, line 1, replace 'no significant' with ' cn insignificant . '
D. On page 3, paragraph 2, add at the end of the paragraph:
This is far below the EPA reporting level of 1 mrem / year required under the Clean Air Act for routine exposures to a member of the public, and the 4 mrem / year EPA limit for public drinking water.
- 6. On page 4, last paragraph, line 9, replace 'a minimal' with
'an insignificant.'
Changes to the Congressional Letters
- 1. In paragraph 2, line 5, replace ' a minimal' with ' an insignificant.'
Changes to the Public Announcement
- 1. On page 1, paragraph 3, lines 4 and 5, replace 'a minimal' with 'an insignificant' and insert ' diagnostic use of the' before ' drug.'
- 2. On page 2, paragraph 1, iine 5, the 'C' in 'carbcn-14' should be lower case.
o L..,
Editorial Changes'to the Final Rule in BBC1r-97-228 Changes to the Federal Reaister notices :
- 1. On page 2, paragraph 1, line 2, replace ' revising
- with
'that vould revise.' In line 6, replace 'are as follows' ,
l with ' involve changes to.'
On page 5, paragraph 2, line 4, insert 'who are cleared for i 2.
unescorted accessafter ' employees.' In paragraph 3, line 4, replace 'discriminte' with ' distinguish. ' In the last paragraph, line 3, replace 'of these' with 'commenter.'
On page e, paragraph 2 under item 5, line 2, replace 3.
' making' with 'make' and in line 4, insert a comma after
'been.' :
?
4 '. On page 11, last line, replace ' assume' with ' assuming.'
changes to the-Congressional letters: .
- 1. In line 1, replace the last 'the' with 'an' so that it reads copy of an amendment to ....'
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