ML20236L340
| ML20236L340 | |
| Person / Time | |
|---|---|
| Issue date: | 07/09/1998 |
| From: | Hoyle J NRC OFFICE OF THE SECRETARY (SECY) |
| To: | Callan L NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| References | |
| REF-10CFR9.7 SECY-98-127-C, NUDOCS 9807100319 | |
| Download: ML20236L340 (10) | |
Text
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._.s'o UNITED STATES e
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'g NUCLEAR REGULATORY COMMISSIQN
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W ASHINGT ON. D.C. 20%5
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July 9, 1998
~
- e OFFICE OF THE SECRETARY l
MEMORANDUM TO:
L. Joseph Callan Exec 4tiv Oire tor for Operations In i
FROM:
Johti C. Hoyle,< scretary
/
SUBJECT:
STAFF REQUIREMENTS: SECY-98-127 - DRAFT PROPOSED POLICY STATEMENT ON THE MEDICAL USE OF BYPRODUCT j
MATERIAL The Commission approved publication in the Ee. deral Reaister of the proposed revision to the Commischn's 1979 Medical Use Policy Statement, subject to the attached editorial changes to the notice, letters to Congress, and draft press release, and the following modification to the notice e
the Statement of Considerations should solicit specific comment on the proposed word l
change in statement 2 from "NRC will minimize intrusion
- to "NRC will not intrude."
The staff should era ure that the planned facilitated workshops and ACMUI meetings focus primarily on the proposed rule rather than on the policy statement and that the Federal Reaister
. notices for the revised policy statement and proposed rule are issued sequentially on the same day and as early in July as possible to allow adequate time for public review prior to the public meetings scheduled to begin in mid-August.
(EDO)
(SECY Suspense:
7/29/98) l
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Attachment:
as stated g
cc:
Chairman Jackson Commissioner Diaz Commissioner McGaffigan OGC 1
CIO CFO OlG l
OCA OPA Office Directors, Regions, ACRS, ACNW. ASLBP (by E-Mail)
9807100319 900709 PDR 10CFR D /*i-b h A1 PT9.7 PDR I
J L._____________________________________________________________
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[7590-01-P]
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l U.S. NUCLEAR REGULATORY COMMISSION Medical Use of Byproduct Material; Draft Policy Statement i
AGENCY: Nuclear Regulatory Comnission, ACTION: Draft Policy Sta'.ement.
SUMMARY
- The Nuclear Regulatory Commission (NRC) is pt oposing for formal comment, N
sevisions of its 1979 policy statement on the me. dical use of byprodwt material. These proposed l
revisions are one component of the Commission's overall program, as previously announced in the Federal Register, for revising its regulatory framework for medical use, including its regulations that govem the medical use of byproduct material. The overall goals of this program are to focus NRC regulation of medical use on those medical piucedures that pose the highest d ue 4frofa %
risk and to structure its regulations to be risk-informed and pe'formance-based, consistent with
'X NRC's " Strategic Plan for Fiscal Year 1997-Fiscal Year 2002."
DATES: Subn. t comments by (insert date 75 days after publication in the Federal Register).
Comments received after this date will be considered if it is practical to do so, but the Commission is able only to ensure consideration of comments received on or before this date.
ADDRESSES: Send comments to: Secretsy, U.S. Nuclear Regulatory Commission, Washington, DC 20555 0001,- Attention: Rulemaking and Adjudications Staff
NRC licensees, other Federal and State agencies, and the general public of the Commission's following general intention in regulating the medical use of byproduct materia!:
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- 1. The NRC will continue to regulate the medical uses of radioisotopes as necessary to nmvide for the radation safety of workers and the general public.
- 2. The NRC will regulate the radiation safety of patients where justified by 'the risk tu i
1 patients and where voluntary standards, or compliance with these standards, are inadequate.
- 3. The NRC will minimize intrusion into medical judgments affecting patients and into other areas traditionally considered to be a part of the practice of medicine.
NRC activities in the medical area, such as promulgation of regulations and i
development of regulatory guidance, as well as cooperative relationships with other Federal agencies, have been guided by this statement.
l A Federal Register notice, " Medical Use of Byproduct Material: Isiues and Request for Public Input" (62 FR 42219-42220; August 6,1997), describes (as reflected below) NRC 's l
l detailed examination of the issues surrounding its medical use program during the last four L
years. This process started with NRC's 1993 intemal senior management review; continued with the 1996 independent extemal review by the National Academy of Sciences (NAS),
!nstitute of Medicine (IOM); and culminated in NRC's Strategic Assessment and Rebaselining bik J.e,;dSA). In particular, medical oversight was addressed in the SA Direction-Sett Paper Number 7 (DSI 7) (releared September 16,1996). In September 1997, the Commission issued hs " Strategic Plan," which stated that its goal in regulating nuclear materials safety is to
" prevent radiation-related deaths or illnesses due to civilian use of source, byproduct, and special nuclear matenals" (NUREG-1614, Vol.1, at 9).
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with the lower overall risk of these procedures, ar.d considering the viability of using or referencing available industry guidance and standards to the extent that they meet NRC needs (62 FR at 42219). This notice solicited informal and formal public input during the rulemaking process on the development of proposed rule language and associated documents (62 FR at 42219-4220). At various stages in this process, the Working / Steering Group placed options for a revised Medical Use Policy Statement and major issues associated with 10 CFR Part 35. and a strawman draft of tha proposed rule language on the Intemet.
In developing a proposed revision of the policy statement, the Commission also has had the benefit of input from the Working / Steering Group, which met publicly in August, September, l
and December 1997 and in January, February, and March 1998; the ACMUI, at its meetings on September 25-26,1997, and March 1-2,1998; ACMUl subcommittee meetings in i
February 1998; " stakeholder" and members of the public at facilitated workshops in October l
and November 1997; professional medical organization meetings; and State regulators at a Ot+eW publicly nuticed workshop at the 1997, "All Agreement States' Meeting. State participants have X
l included representatives of the Organization of Agreement States and the Conference of Radiation Control Program Directors. State participation in this process is intended to further the Commission's strategy to ' work with the Agreement States to assure consistent protection of public health and safety natenwide" (NUREG-1614, Vol.1, at 11). Such State involvement also I
l enhances development of corresponding rules in State regulations; provides an opportunity for earty State input; and allows Staw staff to assess potential impacts of NRC draft language on
' An Agreement State is a State that has signed an agreement with NRC, pursuant to Section 274 of the Atomic Energy Act, allowing the State to regulate the use of radioactive matenal, other than use in reactor facilities, within the State. During the next 5 years, the total number of Agreement States may increase from 30 to 33. NRC " Strategic Plan" (Fiscal year 1997 - Fiscal year 2002), NUREG-1614, Vol. 1 (September 1997), at 9.
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language on the regulation of non-Atomic Energy Act materials used in medical diagnosis, treatment. or research in the States.
At these meetings and workshops, the NRC staff presented attematives and/or dmit text for the Medical Use Policy Statement and 10 CFR Part 35. Altematives generated by workshop participants were also discussed. To ensure that all interests were represented, to the degree possible, invited workshop participants included radiation oncologists, nuclear medicine physicians, other physician specialists (i.e., clinical endocrinologists and l
cardiologists), radiopharmacists, medical physicists, educctors, patient rights advocates, 1
oncology nuts medical technologists, hospital administrators. State and Federal Govemment rubdofficials, and radiopharmaceutical manufacturers. Policy statement attematives ranged from 4F fgwg retaining the status quo to various modifications of the current medical policy such as 1
statements limitino NRC's role in the regulation of medical use to ensuring that the physician's prescription is accurately delive6ed to the correct patient; making clear that NRC will 09.1 intrude into medicaljudgments affecting patients; and providing for NRC assessmct of risks to the radiation safety cf patients that would reference comparable risks, standards, and modes of regulations for other types of medical practice.
The normal pat'em for NRC policy statement pmposals is the development of a 1
proposed policy statement by the NRC staff for Commission consideration, publication of the proposed statement for public comment, consideration of the comments by the NRC staff, and preparation of a final statement, as appropriate, for Commission approval. As directed and approved by the Commission, the NRC staff has increased padicipation in the eariy stages of l
i this development process through meetings and workshops for affected interests and by i
making documents available on the intemet.
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medical use cf byproduct material with risks in other medical modalitiesnin addition, there is not j
an expressed authorization in the AEA to regulate any use of byproduct material on the basis o
" comparable risk " dustifying the significant departure from the Commission's established policy with respect to ris to patients would be, at e minimum, problematic.
- ^ "
- A c.. W A-ata y d \\e da.4s. v m 9 ress skh
- ubiuS, ll. Rationale NRC's prinupal statutory authority for regulating medical use of byproduct material rests on sections 81,161,182, and'183 of the AEA.. Sag 42 U.S.C. $$ 2111,2201,2232, and 2233.
Section 81 of the Act orohibits, without NRC authorization, the manufacture, production, transfer, receipt in interstate commerce, acquisition, ownership, possession, import, and export of byproduct material (42 US.C. $ 2111).
Section 81 of the AEA directs that:.
The Commission shall not permit the distribution of any byproduct material to any licensee, and shall recall or order the recall of any distributed material from any licensee, who is not equipped to observe or who fails to observe such safety standards to orotect health as may be established by the Commission or who uses such material in violation of law or regulation of the Commission or in a manner other than as disclosed in the application therefor or approved by the Commission.
Id. (emphasis added).
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The Statement of Consideration for the proposed 10 CFR Part 35 rulemakings specifically addresses NRC's current policy of consideration of' voluntary standards and I
compliance with such standards." Affirming consideration of industry and professional atandards as part of the NRC policy in achieving radiation safety in medical use conforms to the I
Commission's Strategic Plan. The relevant strategy there stated is to increase the involvement of licensees and others in the NRC regLlatory development process, based on the concepts in the ' National Technology Transfer and Advancement Act of 1995" (the NTTAA), Pub. L. No.
104-113,110 Stat. 775 (1995). Section 12(d) of the NTTAA requires "all Federal agencies and departments to use technical standards that are developed or adopted by voluntary consensus I
bodies... as a means to carry out policy objectives or activitlegn'" EY O'^ ""
shduts.4 is heuwt wA glic4k _lw or e % ;se_.wepcNed."
It is not clear that all " medical industry and professional standards" would meet the i
definition of " technical standards" in Section 12(d)(4) of the NTTAA (" performance-baced or design-specdic technical specifications and related management systems practices)."
Nevertheless, as indicated above, the Commission endorses, in regulating medical use of (4
byproduct material, the concept in Section 12% of the NTTAA, of ' emphasizing, where A
possible, the use of star * "-*, developed by private, consensus organizations." As also stated in the Strategic Plan, the Commission encourages ' industry to develop codes, standards, and guides that can be endorsed by the NRC and carried out by industry."
IV. Policyimplications e
4.m 1
This proposed policy statement affirms the Commission determination that it shall continue its role in regulating the medical use of byproduct material, but with emphasis on the l
l pitt i
k UNITED STATES k
j NUCLEAR REGULATORY COMMISSION 2
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WASHINGTON. D.C. 200eH001 ma egs 4
% L6nL kk The Honorable Dan Schaefer, Chairman l
Subcommittee on Energy and Power
"' " ' g '
Committee on Commerce United States House of Representatives Washington, DC 20515
Dear Mr. Chairman:
Enclosed for the Subcommittee's information is a copy of a notice of a proposed revision to a l
policy statement, to be published in the Federal BanisteI for a 75. day public comment period (Enclosure 1). A copy of the press release for the proposed revision is provided in Enclosure 2.
The U.S. Nudear Regulatory Commission (NRC) is proposing to revise its 1979 " Medical Use Policy Statement," as part of an overall program to revise the Commission's regulatory framework for medical use. The goals of this program are to focus NRC regulation of medical use on tnot,e medical procedures that pose the highest ris nd to structure its regulations to be X
nak-informed an4 performance-based. Another component f the program, the revision of y
10 CFR Part 35, ' Medical Uses of Byproduct Material," will separately published and transmitted to the Subcommittee.
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g g 49, g,c, During the development phase of the proposed policy statement, NRC held public meetings with various interested groups, including physicians, medical associations, patient advocates, Agreement States, and NRC's Advisory Commit 3e on Medical Uses of Isotopes. In addition, proposed attematives for the revised policy statement wereMn the INTERNETgNRC x
received many useful comments as a result of these interacdons with the public, anM has carefully considered them in the development of t licy s1atement.
x yed sed f
h N C*
Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs L NEC wil mN
Enclosures:
l
- 1. Federal Register Notice
- "" N "
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- 2. Press Release cId.
M M M c ~ eA i.d cc: Representative Ralph Hall f1 ib knd in N
% d w ent, t
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Draft press release-5/18/98,1!55 p.m.
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l.
NRC PROPOSES TO REISSUE POLICY STATEMENT ON MEDICAL USES OF RADIOACTIVE MATERIALS i
l l
The Nuclear Regulatory Ccmmission is proposing to revise its licy statement on 4be X
medical uses of radioactive material. The agency intends to focus regulation on medical procedures that pose the highest ris and to structure its regulations to be risk-informed and noce x
puhesb MA -b. pbVc.
,w performance-based.
The proposed policy statement stresses the Commission's determination to continue to regulate the use of radioactive materials in medicine, with the goal of protecting the radiation safety of occupational workers, the public and patients, without intruding into medical judgments affecting patients n justified by the risk, the NRC will regulate the radiation safety of K
patents by ensuring t physician's directions for administration of the radioactive material 4'f ^tof"U q h 45v' d'p^de-//MeCO -
or radiation are followed.
The proposed statement and associated proposed revisions to the agency's regulations, which are expected to be published soon for public comment, result frem the NRC's detailed examination of issues regarding its medical use program during the last five years. This 1993 internal senior management review [r@c r/leucM Q process star +ed with it continued with the M
NRC-requested 1996 independent external review by the National Academy of Sciences, m, %-l-institute of Medicine; and culminated in NRC's strategic assessment and reba x
in September 1997, the Commasion issued its strategic plan, which included the subject of medical oversight and stated that its goal in regulating nuclear materials safety is No prevent
' radiation-related deaths or illnesses due to civilian use of... nuclear materials."
In its March 20,19g7, direction to its staff, the Commission stated that it supported
2 continuation of the ongoing medical use regulatory program with improvements, decreased oversight of low-risk activities, and continued emphasis on high-risk activities. The Commission expressed its support for the continued use of its Advisory Committee on the Medical Use of Isotopes (ACMUI), professional medical organizations and societies, and members of the public in the revision of the regulations and the medical policy stateme d ur essa]
- E in developing the proposed policy statement revision, the Commission established a i
working group and a steering group, made up of members of the NRC staff and state 4
p.Mid et organizations, which held a series of public meetings and k,tkshopt.n 1997 and 998 o
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obtain public and stakeholder suggestions. To ensure that a wide cross-section of interests were represented, invited workshop participants included physicians, radiopharmacists, 4
medical physicists,Neducators, patient rights advocates, nurses, medical technologists, h K
l administrators, re statives of state and federal govemments, and radiopharmaceutical manufacturers.
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l The NRC has received comments on the proposed revision of the medical policy (which was posted on the NRC web site), through meetings of the ACMul, professional medical organization meetings and state regulators. It also has solicited written and electronic l
comments.
Under the proposed new policy statement:
"(1) NRC will continue to regulate the uses of radionuclides in medicine as necessary to provide for the radiation safety of workers and the general public." This portion restates the first part of the current policy statement, issued in 1979, but substitutes the phrase 'uses of radionuclides in medicine" for the phrase ' medical uses of radio sotopes." As noted in an August 6 Federal Register notice requesting public comments on development of l
revised regulabons on medical uses, the Commission "was not persuaded by the National l