ML20147F389
| ML20147F389 | |
| Person / Time | |
|---|---|
| Issue date: | 03/14/1997 |
| From: | Shirley Ann Jackson, The Chairman NRC COMMISSION (OCM) |
| To: | Marcus C CALIFORNIA, UNIV. OF, LOS ANGELES, CA |
| Shared Package | |
| ML19355E827 | List: |
| References | |
| NUDOCS 9703210205 | |
| Download: ML20147F389 (12) | |
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50 \\y UNITED STATES NUCLEAR REGULATORY COMMISSION y
WASHINGTON, D.C. 20561M001 March 14, 1997 CHAIRMAN Carol S. Marcus, Ph.D., M.D.
Director, Nuclear Medicine Outpatient Clinic Harbor-UCLA Medical Center Professor of Radiological Sciences, UCLA 1000 Carson Street 5
Torrance, California 90509
Dear Dr. Marcus:
I am responding to your letters dated January 24, 1997 and February 4, 1997, concerning possible modifications to 10 CFR Part 33 for broad scope licensees, and what you allege to be serious errors in the accuracy of certain NRC j
documents regarding recommendations by the Institute of Medicine of the National Academy of Science (NAS/IOM) in its recent report entitled, Radiation in Medicine - A Need for Reaulatory Reform.
Let me assure you that there is no validity to your charge that the Commission has propagated false information about the NAS report and its recommendations to affected agencies and organizations.
Our goal is to ensure that such reports are publicly 1
available so that interested and affected parties may draw their own conclusions and provide such input to NRC.
Let me also assure you that individual Commissioners and responsible NRC management and staff have read and do understand fully the NAS report and its 3
recommendations, including the dissenting views of Mr. Robert Adler, the sole j
member with regulatory experience. The Commission has been briefed by the NAS, the Advisory Committee on the Medical Uses of Isotopes (ACMUI) and the 1
staff on the report in two public meetings. The staff also has solicited the opinion of other Federal agencies, State agencies, medical professional organizations, and other interested and affected parties on the NAS report.
As you know, the NAS report also has been considered within the context of NRC's Strategic Assessment and Rebaselining Initiative (SA), Direction Setting Issue No. 7, " Materials / Medical Oversight." Based in part on the comments i
received on DSI 7, the preponderance of which supported the Commission's preliminary views, and despite your strong but generally unsupported arguments to the contrary, the Commission continues to believe that the conclusions in the report were not substantiated and that the recommendations should not be pursued. The Commission's views have only been bolstered as a result of the public comments received during SA.
(Enclosed is the summary analysis of i
comments from the Phase II Stakeholder Interaction Report, which you may find i
of interest).
In view of this, the Commission will not allow the discussions at upcoming public workshops on the major revision of Part 35 to be dominated by discussion of the NAS report and its recommendations. We trust that medical profesiional organizations, the ACMUI and others will take advantage W such opportunities to provide meaningful input to, and work with, the NRC staff to help formulate an improved medical use regulatory program.
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You stated that the National ACNP continues to support the NAS recommendations.
This statement is in conflict with the statement of the President of the ACNP during the SA meeting conducted last fall in Washington, h
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He stated that ACNP has modified their previous support for the NAS 4
recommendations and now supports the Commission's preliminary views to continue the ongoing program with improvements and decrease oversight of low-risk activities with continued emphasis in high-risk activities. He did not qualify that ACNP position as one adopted for " damage control" purposes.
l Your statement that the NAS recommended that all medical aspects of the regulatory program "be returned to the only group intellectually capable of handling them, the Medical Board of each state" is incorrect.
Instead, the NAS recognized that most State radiation control programs have a regulatory framework that could accommodate increased authority for the medical use of byproduct material and thus, the NAS/IOM recommended that States take on a greater regulatory role. Many States and the Organization of Agreement States i
indicated a need for Federal oversight and some States identified NRC as the 3
preferred agency. The Conference of Radiation Control Program Directors i
(CRCPD), who the NAS expresses confidence in, commented to NRC that the 4
absence of Federal authority in medical use may have immediate and undesirable consequuces.
Further, the CRCPD did not support the automatic selection of L
the Department of Health and Human Services (HHS) as.the lead Federal agency, as recommended in the NAS report. Nor has HHS sought that role.
1 You also raised the issue regarding regulatory educational requirements for authorized physician users and emphasized that the issue of medical competence 4
is within the jurisdiction of State Boards of Medicine. We fully agree and i
statements from which it is inferred that NRC evaluates the medical competency 4
of its applicants are being misinterpreted or misread.
Rather, NRC's training and experience criteria for physician users are intended to ensure that physicians who seek authorization for medical use have an acceptable level of radiation safety training to ensure the safe handling of byproduct material.
To this end, several training pathways are recognized in NRC's medical use
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regulations, including certification by professional boards such as the i
American Board of Nuclear Medicine.
i j
Regarding naturally-occurring and accelerator-produced radioactive materials (NORM /NARM), comments received during SA indicate a desire by some for NRC i
jurisdiction over NORM and NARM. Such an approach would be risk-based and l
would provide for a consistent and uniform medical use program nationwide.
The Commission would not necessarily discourage such an approach and may even invite such change if an enhanced level of public health and safety would 4
ensue.
In fact, NRC is evaluating these issues with respect to its entire materials program.
With regard to the Quality Management Program provisions of 10 CFR Part 35, the Commission has directed the staff to reevaluate the rule, aided by comments from experts in the medical field, to identify those elements which in the agency's best judgment, are critical to ensure patient and public safety from the use of byproduct materials utilizing a risk-informed, performance-focused approach.
This approach will be applied to Part 35 in its entirety as NRC begins the major revision of Part 35 later this year.
As a result, it is likely that modifications to the rule will lessen the perceived burden to NRC licensees. As stated previou ly, we invite affected and interested parties to participate in this rulemaking process through various
3 opportunities that NRC will provide to solicit input.
However, let me also assure you that on the issue of whether NRC should or should not retain jurisdiction over certain types of byproduct material uses, the Commission will not be persuaded by unsupported arguments, invective and ad hominem remarks.
On the contrary, NRC will continue in its efforts to fulfill its statutory obligation and responsibility for the medical use of byproduct material.
With regard to the recent Advanced Notice of Proposed Rulemaking for 10 CFR Part 33, the staff proposes to consolidate and codify its licensing bases used to license broad scope programs for medical use as found in existing NRC guidance documents. The rulemaking process will provide another opportunity for affected and interested parties to comment on the requirements being considered for inclusion in the rule.
Like the efforts on 10 CFR Part 35, the staff will apply a risk-informed and more performance-focused approach to revisions of 10 CFR Part 33 and related guidance.
The specific comments you raised in your January 24, 1997 letter will be cord dered by the staff as it develops a proposed rule for public comment.
As to your comment on the Office of Management t # Judget (OMB) clearance, the NRC received clearance on the information col 1<<'4an requirements for the recently promulgated patient release rule on Jv.dary 6, 1997.
The. staff believes that it has addressed the concerns raised by OMB and intends to submit the revised regulatory guide to OMB, as requested.
I continue to find the tone of your letters highly unprofessional and your attacks on the integrity of the NRC staff and Commission itself unacceptable.
We recognize that officials of Federal, State and local government are public servants and as a result have a certain obligation to respond to comments and inquiries from members of the public. However, this desirable communications process should not allow or tolerate continued abuse of such officials.
Such tactics generally result in skepticism over the issues you raise and have, in the long run, an effect which I assume you would find contrary to your goals.
If, on the other hand, you have serious concerns regarding specific activities of specific NRC employees or Commissioners, or believe that particular employees or Commissioners have engaged in wrongdoing, I encourage you to report such concerns to the NRC's Office of Inspector General.
In addition, the time and NRC resources expended to respond to your letters have in many cases been excessive.
in the future, while we will continue to consider the issues you raise, you should not expect to receive a response to any letter containing abusive personal attacks on the Commission or the NRC staff.
Likewise, we see no need to expend resources on letters that merely repeat points raised by you and answered by NRC in the past.
Sincerely, Shirley Ann Jackson 4
Enclosure:
As stated
Samary Analysis of Comeus Materials /Mdiad Owrsight j
3.5 MATERIALS / MEDICAL OVERSIGHT (DSI-7) 3.5.1 The Direction-Setting issue and the Options What should be the future role and scope of the NRC's Nucleer Materials Program, and in particular, NRC's regulation of the medicai use of nuclear material.
Option 1:
Increase Regulatory Responsibility With Addition of X-Ray, Accelerators, and Naturally Occurring and Accelerator-Produced Radioactive Materials j
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 j
Oversight of Devices and Manufacturers (National Academy of Sciences Recommendation) i Option 5:
Discontinue Materials Program 3.5.2 Commission's Preliminary Views The Comission 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.
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.
4 In implementing these options with regard to the NRC's medical program, the NRC would consult with its Advisory Comittee 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 4
societies as a potential source for developing professional standards and
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guidance that would be adhered to by NRC medical licensees and could be adopted by the NRC as regulatory requirements.
In the public coments 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 4
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 Comission solicits the public's views on whether a single agency should regulate radiation safety.
Finally, the NRC specifically seeks coments on the Attachment to this issue paper titled " Regulation of Radiation in Medicine - IOM Issues."
Phee 11 Stakeholder lateraalon Report Page 3 47
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L 3.5.3 Summary of Comments i
A.
Significant/Important Comments Directly Affecting the Preliminary Views or the Direction-Setting Issue 1
l In both the written comments and comments made at the stakeholder meetings, J
there was broad support for the options identified in the Commission's preliminary view and for taking serious steps to reduce the burden and 4
intrusiveness of regulations in areas where the risk does not justify it. The j
Organization of Agreement States (OAS), individual' Agreement and non-Agreement States, the Conference of Radiation Control Program Directors (CRCPD) and members of the regulated community (American College of Nuclear Physicians / Society for Nuclear Medicine [ACNP/SNM], American College of 4
j Cardiology [ACC], Council on Radionuclides and Radiopharmaceuticals [CORAR],
American College of Radiology (ACR), Mallinckrodt, Nuclear Energy Institute J
j
[NEI], ABS-CE and Erickson) supported this option.
f i
Most of these commenters called for close coordination with them in any systematic review of and revisions to the regulations to make them more i
performance based as well as in seeking to define low risk. The mechanism most commonly described by the commenters to accomplish this was an enhanced participatory rulemaking.
Examples of areas that could be considered for reduced levels of regulatory oversight included gas chromatographs, nuclear
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pharmacy,.and diagnostic nuclear medicine. One commenter (ACNP/SIM) also felt j
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 i
of this area.
j A consistent theme in the comments was that, while there is a clear need to revise the regulations to be less prescriptive, the removal of all controls i
over the use of radioactive materials is not necessary. Some commenters (OAS, MD, IL, MI, GA) were concerned about the possible adverse' consequences of NRC l
decreasing its level of regulation of low-risk activities and specifically cited problems experienced with gen
- rally licensed devices. They went on to l
state that NRC should not decrease its regulation of such activities for the sake of expediency or resources. Rather, any steps to lessen the level of intensity of regulation should be carefully considered before being undertaken l
and should take into account the fact that some activities may only be low-risk because of the regulatory framework that is in place. One commenter i
(Veterans Administration Medical Center-Lexington,KY), in expressing its support for Option 2, noted that for NRC "to abandon regulatory oversight of i
i diagnostic and therapeutic radiopharmaceuticals would be a serious error" in that such oversight would then fall to the Department of Health and Human i
Services (DHHS), Food and Drug Administration (FDA), which, in this commenter's view, may not be in the best interests of patient care. One commenter (Environmental Coalition on Nuclear Power [ECNP]) was opposed to the i
i preliminary view, stating that regulatory controls over both generally and specifically licensed device as well as medical uses, needed to increase markedly, than decrease.
j 3
Three commenters (CORAR, ACNP/SNM, and Mallinckrodt) reversed their previous positions supporting the preferred option of the ION study based on the i
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 J
materials areas.
i Maase H Stakeholder Emereaum iteport Pase 3-48 i
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u-y Anabein of canunnus Matenals/mdical oversight I
1 1
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 currently drawn between them is an artificial one. Another commenier (NEI) l supported the preliminary view in part, but recommended that NRC expand its scope to include a blend of the other options. This would mean having NRC take on responsibility for all Federal radiation protection standards setting (including X-ray, accelerators, and Naturally Occurring & Accelerator Produced l
Radioactive Materials [NARM), while at the same time devolving regulation of l
all materials licensees to the States, with the exception of major materials licensees (1'.e., those licensees required to maintain Emergency plans). One commenter (Schultz) expressed her support for option 4, but indicated her willingness to support the Commission's preliminary view if the Commission j
rescinded the 1979 Medical Policy Statement and made significant revisions to j
Part 35.
In addition, the Advisory Committee on Medical Uses of Isotopes i
.(ACMUI) indicated that its preference was for a variation of Option 4 as l
provided in the recomunendations resulting from their February 21-22, 1996 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 i
scientific basis of the statement needs to be reviewed with consideration of current research and studies; and the ACMUI is i
committed to working with the staff and Commissioners to provide l
l guidelines for determination of procedures and activities that l
range from low risk to high risk to patients. Therefore, the i
ACMUI recommends that the 1979 Medical-Policy Statement be
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revised.
t One connenter (Marcus) disagreed with the Commission's preliminary view, as j
well as with the issue paper in its entirety.
B.
Comunents on Other Options l
There was also broad support among the commenters (ACNP/SNM, CRCPD, OAS, l
l Mallinckrodt,. NEI, ABB-CE, GA, CO, MD, MI, IL, TN, FL, KS, NJ and TX) for i
Option 1, or a variation thereof, with the commenters stating that all j
exposures to ionizing radiation should be treated equally nationwide. While j
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 i
States should have the responsibility for implementing those standards, others l
felt' that it should also have a regulatory program.
Irrespective of the role, j
there was general support for NRC being the Federal agency responsible for national radiation safety.
I The CRCPD indicated that it should play a major role in the establishment of i
radiation protection standards and that resources should be provided to it for i
this effort.
It was also stated (OAS, 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 l
limited to discrete NARM, but also included resources for regulation of X-ray and linear accelerators.
Several supporters of Option 1 (OAS,TN) stated that, i
if NRC adopted Option 1, it would need to take into account che existing programs of many States and that when'those programs are considered, the resource impacts on NRC might not be as great as projected in the issue paper.
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Page 3-49 Phase 11 Stakeholder interaaion Repon
I MasenalstMediwi omsight sanmary Analysis of commanus One commenter-(MI) supported Option 1, with the exclusion of X-ray machines j
and other radiation machines, which the comenter felt were being adequately i
regulated under the existing Federal-State framework. This commenter also l
noted that all NARM siauld be included under this option, not merely discrete l
NARM sources. Another commenter (TN) stated that NRC should " establish a program to regulate all radioactive material at any concentration which presents a risk beyond that presented by the natural concentrations of 4
4 materials found in-the earth." NThis commenter suggested that Option I should i
also be broadened to include all federal facilities -(including the Department j
of Energy) and that NRC should seekMa waiver of sovereign immunity in order j
for Agreement States to regulate all radioactive material in all facilities" i
One commenter (OR-EN) stated there was no'need to, extend NRC authority to i
include X-ray, accelerators or NORM, but sahi that accelerator-produced radioisotopes should be included under NRC's authority because of the similarities between these materials and byproduct material.
Several commenters (ACNP/SNM, OAS, CRCPD, Mallinckroot, CORAR, GA, KS, MI, NJ, IL) expressed their lack of support for Option 4, indiciting that this option probably represented an'unfunded mandate for the States. Commenters said that i
rather than discontinue the regulation of all medical users,' NRC should recognize the unnecessarily burdensome and prescriptive requiru ents of Part 35 and undertake to revise that regulation. One commenter (NJ) ' stated that "There is no other Federal agency with the vast knowledge and expertence to i
replace the NRC as the agency responsible for medical uses of byprodiict materi al. " Several commenters (CRCPD,IL,TX) indicated that Option. 4 "could have a detrimental impact on the users of radioactive material and the
'N j
citizens of non-Agreement States which are unable to develop a State prograux F
that is not consistent with the national-model" These commenters went on to 'N state that selection of this option could also result in greater N
l jurisdictional confusion at a time when greater consistency is needed.
'x l
Another commenter (IL) stated that this option raised questions about s
inequitable treatment of medical licensees relative to all other material i
j licensees. Two commenters (NEI, ABB-CE) indicated that NRC should discontinue its regulction of all medical activities, and allow FDA to regulate medical devices and activities, with the States regulating industrial and commercial i
j products.
Three comenters (A0MUI, American Society of Nuclear Cardiology, Schultzj supported Option 4, with some indicating a willingness to support the Commission's preliminary view if the Comission made significant changes to j
the 1979 Medical Policy Statement and Part 35..Another commenter (NM) supported Option 4, noting that if Cor.gress does not take the steps recommended in the IOM study, NRC should replace the Quality Management (QM) rule with a more perfomance-based rule and should revised Part 35 in its entirety.
In their views on Optie 4, several commenters (GA,IL,CRCPD) 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 4
radioactive material and the practice of h:edicine."
3 Three commenters (NY, LA, Anonymous) supported Option 5, one of whom (NY) stated that this option was in accordance with the IOM study and the i
recommendations of NRC's National Performance Review Steering Committee.
In a i
variation on Option 5, one comenter (NEI) indicated that NRC should continue i
to regulate only major materials licensees (i.e., those that are required to maintain emergency plans) and should devolve licensing and inspection of all 4
IVuise li Stakedioider Insenuzion Reporr Page.M0 a
l
?-- - - ~iAnalyris of Canonents Materials / Medical Omsight i
other licensees to the States. Another comenter (FL indicated that he l
supported portions of the Comission's preliminary vie)w in the near term, !
stated that Option 5 was his preferred option. Other States felt that Option l
5, as well as Option 4, represented unfunded mandates, abrogations of Federal authority and were not in the best interests of-public health and safety. One i
other commenter (CORAR) indicated that both Options 4 and 5 could lead to non-uniformity between States, which could present logistical. problems to the r9gulated community, and therefore, he could not support either option, j
One commenter (Marcus) proposed an option not expressly addressed in the paper._ Under this option the Comission would stop regulating medicine and 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.
Comments on Important Omissions l
Two commenters (0AS TN) stated that.the issue paper did not contain complete i
discussion on radiation safety issues and made little mention of the fact that the " majority of radiation exposure is.from non-AEA sources...."
One of these commenters (TN) went on to say that the issue paper only dealt with select I
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 i
l 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 RPe 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 i
enforcement is based on compliance to paperwork rather than safety performance."
D.
Comments on Internal / External Factors l
There were limited comments on most of the internal and external factors affecting this DSI, with the exception of full cost recovery. Several commenters (NY, Marcus) said that this factor is a significant one in NRC's
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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 commenter 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 contractors and adoption of rules already developed by Agreement States.
Several commenters (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.
Coments on Staff Requirements Memorandum Questions
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In its preliminary view, the Comission requested specific comments on four issues. Those issues and the coments provided are listed below.
Page FS1 Phee 11 Stakeholder interaction Repon
Merarials/wedical owright s== nary Analyra of comunser i
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3 i
Application of a risk-informed performance-based approach to NRC's oversight i
of medical activities.
j As stated above, the comenters generally supported this approach, not only to NRC's regulation of medical activities, but also to regulation of materials The Organization of Agreement States (OAS) indicated in its consensus j
users.
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" 2
activities solely to reduce its regulatory burden, and that NRC's identification and classification of " low-risk' activities should be done i
carefully and in close consultation with the Agreement States. Several individual Agreement and non-Agreement States agreed with this latter view.
f Feasibility and desirability of having the remaining non-Agreement States acquire Agreement State authority for medical use only l
Commenters did not specifically address this question. However, comments provided on Option 4 indicated that there was little support for this j
approach. Most comenters felt that this option.would represent an unfunded i
mandate for the current non-Agreement States. Other commenters stated that such an approach could result in greater jurisdictional confusion at a time when greater consistency is needed and that this approach could raise questions about inequitable treatment of medical licensees relative to all i
other material licensees.
t i
Whether a single agency should regulate radiation safety l
As stated above, many commenters felt that there was a legitimate role for a j
Federal agency in the regulation of all forms of radiation safety, including NARM. Some felt that the Feder11 role should be limited to merely. standards-setting, leaving the States to implement the standards as they would, without Federal oversight of that implementation. Others felt that the role needed to j
be broader than standards-setting to include regulation of radiation safety.
There was general support for NRC being that agency, whatever the final role 2
In expressing their support for NRC being the regulator of radiation was.
safety, two commenters (CORAR, Mallinckrodt) recommended that another agency i
be responsible for standards-setting and specifically recommended that this agency not be the U.S. Environmental Protection Agency. Commenters also said l
that NRC needs to take into account the existing programs in the States in any j
decision to proceed on this option. However, one comenter (Marcus) said that i
no current Federal agency was appropriate for this role and recommended that a j
new Federal Radiation Council be developed expressly for this purpose.
Specific comments on the attachment to the issue paper entitled " Regulation of j
Radiation in Medicine - IOM issues j
One commenter (OH) specifically commented on this attachment, noting that it did not support the recomendation in the report, to devolve.all regulation to the States with the exception of regulation of manufacturers. Ti.:s commenter j
also felt that the observation in the report regarding the reservations of the regulated community about seeking advice from the NRC was not a valid one.
Finally, this commenter stated that the Department of Health and Human Services (DHHS), the agency recommended in the ION report for Federal guidance 4
i Phase 11 Stakeholder internesion Report l
Page 3-52
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1 Sannmenry Analysis af r%.amanner Maserials/Madical Outrsight in the medical area, does not have an extensive history in regulation of radiation protection. Other commenters did not specifically comment on this attachment, but related comments on Option 4 are discussed above.
3.5.4 List of Commenters
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WRITTEN C0ptiENTS 1.
August 1, 1996, State of New Mexico (Gary E. Johnson) 2.
September 16, 1996, American College of Nuclear Physicians / Society for 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 o? Agreement States & Conferences of Radiation Control Program Directors (Robert Quillin) 6.
October 23, 1996, State of New York, Department of Labor (Rita Aldrich) 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) 10.
November 4,1996, State of New Hampshire Department of Health and Human Services (Diane Tefft) 11.
November 5,1996, State of Michigan Department of Environmental Quality (Flint C. Watt) 12.
November 6,1996, American Society of Nuclear Cardiology (Mario Verani) 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) 16.
November 8,1996, State of Tennessee, Department of Environment and Conservation (Michael Mobley) 17.
November 12, 1996, William Beaumont Hospital (Cheryl Culver Schultz)
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18.
November 12, 1996, State of Kansas, Department of Health and Environment (Ronald G. Fraass) 19.
November 13, 1996, State of Oregon, Office of Energy (David Stewart-Smith)
Phase !! Stakeholder interaaion Repon Page 3-53
& n Analysis of r-"
maniaWmkal oursight
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20.
November 13, 1996, State of Oregon, Department of Human Resources (Ray a
1 D. Paris)
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21.
November 14, 1996, State of South Carolina, Department of Health and Environmental Control (Max K. Batavia) 22.
November 21, 1996, State of Louisiana, Department of Environmental Quality (Ronald Wascom) 2 s
i 23.
November 21, 1996, State of Georgia, Department of Environmental l
i Resources (Thomas E. Hill) i 24.
November 21, 1996, State of Utah, Department of Environmental Quality (William J. Sinclair) i' 25.
November 21, 1996, Siemens Power Corporation (L. J. Maas) l 26.
November 22, 1996, South Carolina Electric and Gas (Gary J. Taylor) f 27.
November 26, 1996, ACMU1 (Judith Anne Stitt) 28.
November 27, 1996, American College of Radiology (Melanie T. Young) l 29.
November 27, 1996, Nuclear Energy Institute (Thomas D. Ryan) l 30.
November 27, 1996, State of Texas, Department of Health (Richard Ratliff) a
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31.
November 27, 1996, CRCPD (William P. Dornsife) 1 32.
November 27, 1996, CORAR (Roy W. Brown) 33.
November 27, 1996, Department of Veteran Affairs, Lexington Medical Center (John J. Coupal) 34.
November 27, 1996, A.N. Tschaeche i
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) 3 41.
December 2,1996, Stats cf Illinois, Department of Nu.: lear Safety (Thomas W. Ortciger) 42.
December 3, 1996, No Name Phase !!.9ahnholder Innensanon Repers Page3-54
Summary Analynit of Canneur Materials /hiical Omsight
^
l ORAL COMENTS Washington, D.C. (October 24 - 25, 1996) pages 87 - 109 1.
Darrell McIndoe, ACNP/SNM 2.
Thomas Hill, Organization of Agreement States I
3.
Roy Brown, CORAR 4.
Ruth McBurney, Council of Radiation Control Program Directors j
Colorado Springs, CD (October 31 - November 1,1996) pages 185 - 195) 1.
Ashak Dhar, Mallinckrodt Medical, Inc.
2.
William J. Sinclair, Organization of Agreement States 3.
Ken Weaver, State 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
[
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 I
7.
Jim Williams, State of Ohio 8.
George Oliver, Unity Health System
)
9.
Gordon Appel, State of Illinois, Department of Nuclear Safety Page 3 55 Phase !! Stakeholder Interaction Report