ML20137J177
| ML20137J177 | |
| Person / Time | |
|---|---|
| Issue date: | 04/01/1997 |
| From: | Hoyle J NRC OFFICE OF THE SECRETARY (SECY) |
| To: | NRC OFFICE OF THE SECRETARY (SECY) |
| Shared Package | |
| ML20137J180 | List: |
| References | |
| COMSECY-96-057, COMSECY-96-57, DSI-7, SECY-96-057-C, SECY-96-57-C, NUDOCS 9704030237 | |
| Download: ML20137J177 (11) | |
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4 April 1, 1997 4
SECY NOTE:
The following documents are being released to the i
public at this time:
I 1.
Text of DSI 7 (Materials / Medical Oversight)
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2.
Staff Requirements Memorandum dated March 20, 1997.
3.
Views of Chairman Jackson dated January 17, 1997.
4.
Views of Commissioner Rogers dated January 21, 1997.
5.
Views of Commissioner Dicus dated January 27, 1997.
6.
Views of Commissioner Diaz dated January 27, 1997.
7.
Views of Commissioner McGaffigan dated February 7, 1997.
r John C. Hoyle Secretary of the Commission
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Summary Analysis of Comments Materialt/ Medical Oversight COMSfCY-96-05 i
3.5 M ATERI ALS/ MEDICAL OVERSIGHT (DSI-7) e je M:
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3.5.1 The Direction-Setting issue and the Options
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What should be the future role and scope of the NRC's Nuclear Materials o
a Program, and in particular, NRC's regulation of the medical use of nuclead F-material.
7 1
.m 0-Accelerators, and Naturally Occurring and Accelerator-Produc N
Increase Regulatory Responsibility With Addition of X-Ray, a
Option 1:
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't Radioactive Materials m
Option 2:
Continue Ongoing Program (With Improvements)
Option 3:
Decrease Oversight of Low-Risk Activities with Continued Emphasis of High-Risk Activities Option 4:
Discontinue Regulation of All Medical Activities Except NRC Oversight of Devices and Manufacturers (National Academy of Sciences Recommendation) l Option 5:
Discontinue Materials Program 3.5.2 Commission's Preliminary Views The Commission preliminarily favors a combination of Option 2 (Continue the Ongoing Program (with Improvements]) and Option 3 (Decrease Oversight of Low-Risk Activities with Continued Emphasis of High-Risk Activities).
In implementing Option 3, the NRC would utilize the risk-informed performance-based approach, as discussed in DSI 12, to determine which activities in the materials area, and specifically in the medical area, are low-risk activities.
l The general approach described in Option 3 of this DSI appears to be a reasonable starting point for identifying the types of activities that can be affected by this process.
In implementing these options with regarc to the NRC's medical program, the NRC would consult with its Advisory Committee on the Medical Uses of Radioisotopes (ACMUI) for guidance on low-risk medical activities, revisions to 10 CFR 35, and possible implementation methods. The NRC would also evaluate the feasibility of using professional medical organizations and societies as a potential source for developing professional standards and guidance that would be adhered to by NRC medical licensees and could be adopted by the NRC as regulatory requirements.
In the public comments on this issue, the NRC particularly solicits the views of other affected organizations such as the Organization of Agreement States and the CRCPD on applying a risk-informed performance based approach to NRC's oversight of medical activities. The NRC also solicits the public's views on the feasibility and desirability of NRC's striving to have the remaining non-Agreement ' States acquire Agreement State authority for medical-use only.
In addition, the Commission solicits the public's views on whether a single agency should regulate radiation safety.
Finally, the NRC specifically seeks comments on the Attachment to this issue paper titled " Regulation of Radiation in Medicine - IOM Issues."
Page 3-47 Phase !! Stakeholder interaaion Report
'~ iwnmary Analysis of comments
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uateriawuedical oursighi f
3.5.3 Summary of Comments A.
Significant/Important Coment., Dirm ly Af fect1ng the Preliminary Views or the Direction-Sett hg inue In both the written coments 'and comments made at the stakeholder meetings, there was broad support for the options ider,tified in the Comission's preliminary view and for taking serious steps to reduce the burden and intrusiveness of regulations in areas where the risk does not justify it. The Organization of Agreement States (0AS), individual Agreement and non-Agreement States, the Conference of Radiation Control Program Directors (CRCPD) and members of the regulated comunity (American College of Nuclear
)
Physicians / Society for Nuclear Medicir. [ACNP/SNM), American College of Cardiology [ACC], Council on Radionuclides and Radiopharmaceuticals (CORAR),
American College of Radiology (ACR), Mallinckrodt, Nuclear Energy Institute
[NEI], ABB-CE and Erickson) supported this option.
i Most of these commenters called for close coordination with them in any
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systematic review of and revisions to the regulations to make them more The mechanism performance based as well as in seeking to define low risk.
most comonly described by the comenters to accomplish this was an enhanced Examples of areas that could be considered for participatory rulemaking.
reduced levels of regulatory oversight included gas chromatographs, nuclear pharmacy, and diagnostic nuclear medicine. One commenter (ACNP/SNM) also felt that the relative risk of therapeutic nuclear medicine needs to be reexamined and that it could be that such a reexamination could lead to general licensing of this area.
A consistent theme in the coments was that, while there is a clear need to
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revise the regulations to be less prescriptive, the removal of all controls Some comenters (OAS, over the use of radioactive materials is not necessary.
MD, IL, MI, GA) were concerned about the possible adverse consequences of NRC decreasing its level of regulation of low-risk activities and specifically cited problems experienced with generally licensed devices. They went on to state that NRC should not decrease its regulation of such activities for the Rather, any steps to lessen the level of sake of expediency or resources.
intensity of regulation should be carefully considered before being undertaken and should take into account the fact that som activities may orly be low-risk because of the regulatory framework that is in place. One comenter (Veterans Administration Medical Center-Lexington,KY), in expressing its support for Option 2, noted that for NRC "to abandon regulatory oversight of diagnostic and therapeutic radiopharmaceuticals would be a serious error" in that such oversight would then fall to the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), which, in this comenter's view, may not be in the best interests of patient care. One comenter (Environmental Coalition on Nuclear Power (ECNP]) was opposed to the preliminary view, stating that regulatory controls over both generally and specifically licensed device as well as medical uses, needed to increase markedly, than decrease.
Three comenters (CORAR, ACNP/SNM, and Mallinckrodt) reversed their previous positions supporting the preferred option of the IOM study based on the prospect of working with NRC in Options 2 and 3 to review the regulations based on risk and to reduce the burden of regulation in the medical and materials areas.
Phase 11 Stakeholder interaction Report Page 3-48
Materials / Medical Owrsight Sw, unary Analysis of Cominents Three commenters (KS, OR-EN, CORAR) supported Option 2 with the addition of accelerator-produced radioisotopes, noting that because of the similarities between these materials and byproduct material, the distinction that is Another commenter (NEI) currently drawn between them is an artificial one.
supported the preliminary view in part, but recomended that NRC expand its This would mean having NRC scope to include a blend of the other options.
take on responsibility for all Federal radiation protection standards setting (including X-ray, accelerators, and Naturally Occurring & Accelerator Produced Radioactive Materials [NARM], while at the same time devolving regulation of all materials licensees to the States, with the exception of major materials One licensees (i'.e., those licensees required to maintain Emergency plans).
commenter (Schultz) expressed her support for Option 4, but indicated her willingness to support the Commission's preliminary view if the Commission rescinded the 1979 Medical Policy Statement and made significant revisions to Part 35.
In addition, the Advisory Committee on Medical Uses of Isotopes (ACMUI) indicated that its preference was for a variation of Option 4 as 21-22, 1996 provided in the recommendations resulting from their February meeting. The ACMUI went on to state that, given that these recommendations were not part of the Commission's preliminary view --
The 1979 Medical Policy Statement should be reconsidered; and the scientific basis of the statement needs to be reviewed with consideration of current research and studies; and the ACMUI is committed to working with the staff and Commissioners to provide guidelines for determination of procedures and activities that range from low risk to high risk to patients. Therefore, the ACMUI recommends that the 1979 Medical Policy Statement be revised.
One commenter (Marcus) disagreed with the Commission's preliminary view, as well as with the issue paper in its entirety.
B.
Comments on Othu Options There was also broad support among the commenters (ACNP/SNM, CRCPD, OAS, Mallinckrodt, NEI, ABB-CE, GA, 00, MD, MI, IL, TN, FL, KS, NJ and TX) for Option 1, or a variation thereof, with the commenters stating that all exposures to ionizing radiation should be treated equally nationwide. While some commenters felt that a Federal agency with the mandate to address all sources of radiation should only have standard-setting authority and that the States should have the responsibility for implementing those standards, others felt that it should also have a regulatory program.
Irrespective of the role, there was general support for NRC being the Federal agency responsible for national radiation safety.
The CRCPD indicated that it should play a major role in the establishment of radiation protection standards and that resources should be provided to it for this effort.
It was also stated (0AS, CORAR, Mallinckrodt) that the resource estimates for this option seemed unusually high.
Staff clarified this comment in the Washington, D.C. stakeholder meeting by stating that Option I was not limited to discrete NARM, but also included resources for regulation of X-ray and linear accelerators. Several supporters of Option 1 (0AS,TN) stated that, if NRC adopted Option 1, '.t would need to take into account the existing programs of many States ed tLat when those programs are considered, the resource impacts on NRC might not be as great as projected in the issue paper.
Phase 11 S'akeholder interaction Report Page 3-19
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MatedaisiMedical Owrsight gummary 2nigsis 4f%ms One commenter (MI) supported Option 1, with the exclusion of X-ray machines e
and other radiation machines, which the commenter felt were being adequately regulated under the existing Federal-Shte framework.
This commenter also noted that all NARM should be included under th-is option, not merely discrete NARM sources. Another commenter (TN) st'ated that NRC should " establish a program to regulate all radioactive material at a.ny concentration which presents a risk beyond that presented by the natural concentrations of materials found in the earth.* This commenter suggested that Option I should 1
also be broadened to include all Federal facilitles (including the Department of Energy) and that NRC should seek "a waiver of sovereign imunity in order l
for Agreement States to r alate all radioactive material in all facilities" One commenter (OR-EN) st; e.J there was no need to. extend NRC authority to include X-ray, accelerators or NORM, but said that accelerator-produced radioisotopes should be included under NRC's authority because of the similarities be, tween these materials and byproduct material.
Several commenters (ACNP/SNM, 0AS, CRCPD, Mallinckrodt, CORAR, GA, KS, MI, NJ, IL) expressed their lack of support for Option 4, indicating that this option probably represented an unfunded mandate for the States. Commenters said that rather than discontinue the regulation of all medical users, NRC should recognize the unnecessarily burdensome and prescriptive requirements of Part 35 and undertake to revise that regulation. One comenter (NJ) stated that "There is no other Federal agency with the vast knowledge and experience to replace the NRC as the agency responsible for medical uses of byproduct materi al. " Several commenters (CRCPD,IL,TX) indicated that Option 4 "could have a detrimental impact on the users of radioactive material and the citizens of non-Agreement States which are unable to develop a State program that is not consistent with the national model" These commenters went on to state that selection of this option could also result in greater jurisdictional confusion at a time when greater consistency is needed.
Another commenter (IL) stated that this option raised questions about i
inequitable treatment of medical licensees relative to all other material licensees. Two comenters (NEI, ABB-CE) indicated that NRC Shuld discontinue its regulation of all medical activities, and allow FDA to r< plate medical
.nd commercial devices and activities, with the States regulating industriai products.
Three commenters (ACMUI, American Society of Nuclear Cardiology, Schultz) supported Option 4, with some indicating a willingness to support the Comission's preliminary view if the Commission made significant changes to the 1979 Medical Policy Statement and Part 35. Another commenter (NM) supported Option 4, noting that if Congress does not take the steps recommended in the IOM study, NRC should replace the Quality Management (QM) i rule with a more performance-based rule and should revised Part 35 in its i
In their views on Option 4, several commenters (GA,IL,CRCPD) entirety.
recommended that "NRC, FDA and representatives from applicable boards of medicine and pharmacy should jointly develop a paper describing the jurisdiction boundaries of each entity relative to regulated use of radioactive materi.1 and the practice of medicine."
Three commenters (NY, LA, Anonymous) supptrted Option 5, one of whom (NY) stated that this option was in accordance with the IOM study and the recomendations of NRC's National Performance Review Steering Committee.
In a variation on Option 5, one commenter (NEI) indicated that NRC should continue to regulate only major materials licensees (i.e., those that are required to maintain emergency plans) and should devolve licensing and inspection of all i
Phase H Stakeholder interaaion Report Page 3-50
Materials / Medical Owrsight
- Sununary Analysis of Corninents Another comenter (FL) indicated that he other licensees to the States.
supported portions of the Commission's preliminary view in the near term, but Other States felt that Option stated that Option 5 was his preferred option.
5, as well as Option 4, represented unfunded mandates, abrogations of Federal One authority and were not in the best interests of public health and safety.
other commenter (CORAR) indicated that both Options 4 and 5 could lead to non-uniformity between States, which could present logistical problems to the regulated comunity, and therefore, he could not support either option.
One commenter (Marcus) proposed an option not expressly addressed in the Under this option the Comission would stop regulating medicine and paper.
pharmacy, increase the qualifications for physician-authorized users, and regulate nuclear medicine and nuclear pharmacy only on the basis of the radiation protection standards contained in Part 20.
C.
Coments on Important Omissions Two commenters (0AS,TN) stated that the issue paper did not contain complete discussion on radiation safety issues and made little mention of the fact that One of these the " majority of radiation exposure is from non-AEA sources...."
commenters (TN) went on to say that the issue paper only dealt with select l
options and that discussion of those options did not " allow a fair unbiased assessment of one option versus other options...."
Two commenters (NEI, Siemens) stated that the issue paper focused only on byproduct material licensees, to the exclusion of source material and special nuclear material licensees. One commenter (NEI) felt that the issue paper may have been too limited in its focus on the QM Rule as a major issue, in that this rule affects only a small portion of the regulated community. This commenter went on to note that NRC materials regulations are "too prescriptive and enforcement is based on compliance to paperwork rather than safety performance."
D.
Coments on Internal / External Factors There were limited comments on most of the internal and external factors Several l
affecting this DSI, with the exception of full cost recovery.
commenters (NY, Marcus) said that this factor is a significant one in NRC's consideration of this DSI. One (NY) went on to state that the decline in licensee population as a result of full cost recovery stands to make NRC's materials program nonviable, This comenter said that the success of the Agreement State program makes the NRC materials program more marginal economically and difficult to support and offered ways to reduce NRC costs.
These included greater use of technical staff to perform work normally done by I
contractors and adoption of rules already developed by Agreement States.
I Several comenters (OH, CORAR, GA, CRCPD) expressed their support for the Business Process Reengineering (BPR) effort as well as other NRC initiatives to streamline and improve the regulatory process. One commenter (GA) expressed the view that rather than spend resources on enforcement and civil penalties, the agency should spend more time visiting and inspecting licensed facilities.
E.
Comments on Staff Requirements Memorandum Questions In its preliminary view, the Comission requested specific comments on four issues. Those issues and the comments provided are listed below.
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Page 3-51 Phase 11 Stakeholder Interaaion Repon
Materials / Medical Owrsight Summary Analysis of Comment.1 Application of a risk-informed performance-based approach to NRC's oversight of medical activities.
As stated above, the comenters generally supported this approach, not only to NRC's regulation of medical activities, but also to regulation of materials users.
The Organization of Agreement States (OAS) indicated in its consensus view that a risk-based approach to regulation was favored by most of the States, but that the criteria must be applied both to existing and proposed regulations.
0AS felt that NRC must not abandon control over " low-risk" activities solely to reduce its regulatory burden, and that NRC's identification and classification of " low-risk" activities should be done l
carefully and in close consultation with the Agreement States. Several individual Agreement and non-Agreement States agreed with this latter view.
Feasibility and desirability of having the remaining non-Agreement States acquire Agreement State authority for medical use only Commenters did not specifically address this question. However, comments provided on Option 4 indicated that there was little support for this esproatii..'b:t mmmenters felt that this option would represent an unfunded mardate for the current non-Agreement States.
Other commenters stated that such an approach could r:sqlt in greater jurisdictional confusion at a time when greater consistency is needed and that this anproach could raise questions about inequitable treatment of medical licensees relative to all other material licensees.
Whether a single agency should regulate radiation safety As stated above, many commenters felt that there was a legitimate role for a Federal agency in the regulation of all forms of radiation safety, including NARM.
Some felt that the tederal rule sheuld be linited to merely. standards-
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setting, leaving the States to implement the standards as they would, without Federal oversight of that implementation. Others felt that the role needed to be broader than standards-setting to include regulation of radiation safety.
There was general support for NRC being that agency, whatever the final role was.
In expressing their support for NRC being the regulator of radiation safety, two commenters (CORAR, Mallinckrodt) recommended that another agency be responsible. for standards-setting and specifically recommended that this agency not be the U.S. Environmental Protection Agency. Commenters also said that NRC needs to take into account the existing programs in the States in any decision to proceed on this option. However, one commenter (Marcus) said that no current Federal agency was appropriate for this role and recommended that a new Federal Radiation Council be developed expressly for this purpose.
Specific coments on the attachment to the issue paper entitled " Regulation of Radiation in Medicine - IOM issues One comenter (OH) specifically comented on this attachment, noting that it did not support the recommendation in the report, to devolve all regulation to the States with the exception of regulation of manufacturers. This commenter also felt that the observation in the report regarding the reservations of the regulated comunity about seeking advice from the NRC was not a valid one.
Finally, this commenter stated that the Deoartment of Health and Human Services (DHHS), the agency recommended in the IOM report for Federal guidance Page 3-52 Phase 11 Stakeholder interaction Report
Materialsmedical owrsigla
' swnmarj Nalysis of comments in the medical area, does not have an extensive history in regulation of Other commenters did not specifically comment on this radiation protection.
on Option 4 are discussed above.
attachment, but related comment::
3.5.4 List of Commenters WRITTEN COMMENTS August 1, 1996, State of New Mexico (Gary E. Johnson) 1.
September - 16, 1996, American Collye of Nuclear Physicians / Society for 2.
Nuclear Medicine (David R. Brill / Michael D. Devous) 3.
October 16, 1996, ACNP/CA Chapter (Dr. Carol S. Marcus) 4.
October 18, 1996, ACNW/CA Chapter (Dr. Carol S. Marcus) 5.
-October 21, 1996, Organization of Agreement States & Conferences of Radiation Control Program Directors (Robert Quillin)
State of New York, Department of Labor (Rita Aldrich) 6.
October 23, 1996, 7.
October 23, 1996, Summary of Agreement State Regulators Meeting 8.
October 28, 1996, State of Washington Department of Health (Terry Frazee) 9.
October 31, 1996, State of Florida (William A. Passetti)
November 4,1996, State of New Hampshire Department of Health and Human 10.
Services (Diane Tefft)
November 5,1996, State of Michigan Department of Environmental Quality 11.
(Flint C. Watt)
November 6,1996, American Society of Nuclear Cardiology (Mario Verani) 12.
13.
November 6,1996, Environmental Coalition on Nuclear Power (Judith Johnsrud) 14.
November 7,1996, State of Mississippi, Department of Health (Robert W.
(
Goff) 15.
November 7, 1996, American College of Cardiology (Richard Lewis) l 16.
November 8, 1996, State of Tennessee, Department of Environment and Conservation (Michael Mobley) 17.
November 12, 1996, William Beaumont Hospital (Cheryl Culver Schultz) l 18.
November 12, 1996, State of Kansas, Department of Health and Environment (Ronald G. Fraass) l l
19.
November 13, 1996, State of Oregon, Office of Energy (David Stewart-Smith)
Page 3-53 Phase 11 Stakeholder interaction Repon
l Materials / Medical Oversight Summary Analysis of Comments i
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F 20.
November 13, 1996, State of Oregon, Department of Human Pesources (Ray l
D. Paris) l 21.
November 14, 1996, State of Souit Carchim, Diyartmer.t of Health and Environmental Control (Max K. Batavia) 22.
November 21, 1996, State of Lcnns:iara Department of Environmental Quality (Ronald Wascom) l 23.
November 21, 1996, State of Georgia, Department of Environmental l
Resources (Thomas E. Hill) 24.
November 21, 1996, State of Utah, Department of Environmental Quality (William J. Sinclair) 25.
November 21, 1996, Siemens Power Corporation (L. J. Maas) 26.
November 22, 1996, South Carolina Electric and Gas (Gary J. Taylor) l 27.
November 26, 1996, ACMUI (Judith Anne Stitt) i 28.
November 27, 1996, American College of Radiology (Melanie T. Young) 29.
November 27, 1996, Nuclear Energy Institute (Thomas D. Ryan) 30.
November 27, 1996, State of Texas, Department of Health l
(Richard Ratliff)
[
31.
November 27, ISS~,, CRCPD (William P. Dornsife) l 32.
November 27, 1996, CORAR (Roy W. Brown) 33.
November 27, 1996, Department of Veteran Affairs, Lexington Medical Center (Jolin J. Coupal) 34.
November 27, 1996, A.N. Tschaeche 35.
December 2,1996, ACNP/SNM (David R. Brill and Michael D. Devous) 36.
December 2, 1996, State of Ohio, Department of Health (Robert E. Owen) 37.
December 2, 1996, State of New Jersey (Jill Lipoti) 38.
December 2,1996, State of Maryland (Roland G. Fletcher) 39.
December 2,1996, Mallinckrodt Medical, Inc. (Ashok Dhar) 40.
December 2,1996, ABB-CE (Charles B. Brinkman) l 41.
December 2,1996, State of Illinois, Department of Nuclear Safety (Thomas W. Ortciger) i 42.
December 3, 1996, No Name i
Pige 3-54 Phase 11 Stakeholder Interaaion Repon i
Materials / Medica! Oversight Summey healysis of comments ORAL COMMENTS Washington, D.C. (October 24 - 25, 1996) pages 87 - 109 1.
Darrell McIndoe, ACNP/SNM 2.
Thomas Hill, Organization of Agreement States 3.
Roy Brown, CORAR Ruth McBurney, Council of Radiation Control Program Directors 4.
colorado SprinCs, CO (October 31 -- November 1, 1996) pages 185 - 195) 1.
Ashak Dhar, Mallinckrodt Medical, Inc.
William J. Sinclair, Organization of Agreement States 2.
3.
Ken Weaver, Sta~te of Colorado Chicago, IL (November 7 - 8,1996 pages 196 - 227 1.
Kathy Allen, State of Illinois, Department of Nuclear Safety 2.
Steve Collins, Organization of Agreement States f
3.
Cheryl Schultz, William Beaumont Hospital 4.
Mark Doruff, Amersham Corporation, Representing CORAR 5.
Reg Ronnigen, Michigan State University 6.
Kristen Erickson, Michigan State University 7.
Jim Williams, State of Ohio 8.
George Oliver, Unity Health System Gordon Appel, State of Illinois, Lepartment of Nuclear Safety 9.
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