ML20248L971
| ML20248L971 | |
| Person / Time | |
|---|---|
| Issue date: | 06/04/1998 |
| From: | Shirley Ann Jackson, The Chairman NRC COMMISSION (OCM) |
| To: | Santorum R SENATE |
| Shared Package | |
| ML20248L972 | List: |
| References | |
| NUDOCS 9806120175 | |
| Download: ML20248L971 (1) | |
Text
f UNITED STATES 4
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NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 e
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p June 4, 1998 CHAIRMAN The Honorable Rick Santorum United States Senate Washington, D.C. 20510-3004
Dear Senator Santorum:
I am responding to your letter dated April 25,1998, regarding the concerns of your constituents about possible changes in the U.S. Nuclear Regulatory Commission's (NRC) 10 CFR Part 35 regulations on medical use of byproduct material. In particular, you were concerned about the training and experience requirements that would be applicabia to personnel involved in diagnostic uses of unsealed byproduct material.
The NRC staff is scheduled to provide its recommendations on proposed revisions to Part 35 to the Commission in June 1998. The proposed rule is being developed using an increased public participation process that included public workshops; meetings with various medical professional societies (including the American College of Radiology); and the posting of a "strawman" rule text on the Internet for comments. The staff is carefully considering the comments received during these interactions, in preparing the proposal. After Commission approval, a proposed rule will be published in the Federal Reaister for public comment. We expect to hold additional public meetings during the comment period later this year.
The issue of training and experience has received the most comments during the development of the proposed rule. Viewpoints on this issue have varied. The Commission has received comments both supporting reduction in requirements affecting personnel in the diagnostic area, including those from American College of Cardiology and the American Society of Nuclear Cardiologists, and favoring keeping the presently existing requirements. The staff draft, while reducing the number of hours required for certain medical modalities, also specified a focus on radiation safety and proposed that personnel competency be verified through an examination.
This proposal appears to be in keeping with the direction the Commission provided to the staff namely, to develop a risk-informed, and where appropriate, a more performance-based rule and it addressed an objection often expressed by some commenters, that NRC requirements sometimes intruded into the practice of medicine.
The Commission will carefully consider the staff proposal in light of public comments such as your constituents' when it is received. The results of that consideration will then be available fo-i additional public comment and discussion.
! i Sincerely, I
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,i Shirley Ann Jackson n,
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f UNITED STATES e-4t NUCLEAR REGULATORY COMMISSION I
S WASH.NGToN, D.C. 20555-0001 k..... p l 5
8 June 4, 1998 CHAMMAN l
The Honorable David McIntosh United States House of Representatives Washington, D.C. 20515-1402
Dear Congressman McIntosh:
I am responding to your letter dated April 29, f998, in which you expressed reservations about possible changes in the U.S. Nuclear Regulatory Commission's (NRC) 10 CFR Part 35 regulations on medical use of byproduct material in particular, you were concerned about the traiaing and experience requiremaats that would be applicable to personnel involved in diagnostic and therapeutic uses of unsealed byproduct material.
The NRC staff is scheduled to provide its recommendations on proposed revisions to Part 35 to the Commission in June 1998. The proposed rule is being developed using an increased public participation process that included public workshops; meetings with various medical professional societies (including the American College of Radiology); and the posting of a "strawman" rule text on the Internet for comments. The staff is carefully considering the comments received during these interactions, in preparing the proposal. After Commission approval, a proposed rule will be published in the Eederal Register for public comment. We expect to hold additional public meetings during the comment period later this year.
The issue of training and experience has received the most comments during the development of the proposed rule. Viewpoints on this issue have varied. The Commission has received comments both supporting reduction in requirements affecting personnelin the diagnostic area, including those from American College of Cardiology and the American Society of Nuclear Cardiologists, and favoring keeping the presently existing requirements. The staff draft, while reducing the number of hours required for certain medical modalities, also specified a focus on radiation safety and proposed that personnel competency be verified through an examination.
This proposal appears to be in keeping with the direction the Commission provided to the staff l
namely, to develop a risk-informed, and where appropriate, a more performance-based rule and it addressed an objection often expressed by some commenters, that NRC requirements sometimes intruded into the practice of medicine.
1 The Commission will carefully consider the staff proposalin light of comments such as yours when it is received. The results of that consideration will then be available for additional public comment and discussion.
Sincerely, Shirley Ann Jackson i
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WASHINGTON. D.C. 20555-0001 June 4, 1998 CHAIRMAN The Honorable Mitch McConnell United States Senate Washington, D.C. 20510-1702
Dear Senator McConnell:
I am responding to your letter dated April 27,1998, regarding the concerns of your constituents about possible changes in the U.S. Nuclear Regulatory Commission's (NRC) 10 CFR Part 35 regulations on medical use of byproduct material. In particular, you were concerned about the training and experience requirements that would be applicable to oersonnel involved in diagnostic and therapeutic uses of unsealed byproduct ma^erial.
The NRC staff is scheduled to provide its recommendations on proposed revisions to Part 35 to the Commission in June 1998. The proposed rule is being developed using an increased public participation process that included public workshops; meetings with various medical professional societies (including the American College of Radiology); and the posting of a "strawman" rule text on the Internet for comments. The staff is carefully considering the comments received during these interactions, in preparing the proposal. After Commission approval, a proposed rule will be published in the Federal Reaister for public comment. We expect to hold additional public rneetings during the comment period later this year.
The issue of training and experience has received the most comments during the development of the proposed rule. Viewpoints on this issue have varied. The Commission has received comments both supporting reduction in requirements affecting personnel in the diagnostic area, including those from American College of Cardiology and the American Society of Nuclear l
Cardiologists, and favoring keeping the presently existing requirements. The staff draft, while l
reducing the number of hours required for certain medical modalities, also specified a focus on j
radiation safety and proposed that personnel competency be verified through an examination.
This proposal appears to be in keeping with the direction the Commission provided to the staff namely, to develop a risk-informed, and where appropriate, a more performance-based rule and it addressed an objection often expressed by some commenters, that NRC requirements i
sometimes intruded into the practice of medicine.
i The Commission will carefully consider the staff proposal in light of public comments such as l
your constituents' when it is received. The results of that consideration will then be available for additional public comment and discussion.
1 Sincerely, Shirley Ann Jackson
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WASHINGTON DC 20510 3804 RULE S 202-224-6324 aarno April 25, 1998 The Honorable Shirley Ann Jackson Chairman Nuclear Regulatory Commission One White Flint North Building 11555 Rockville Pike Rockville, Maryland 20852-2739
Dear Chairman Jackson,
I have recently received correspondence from several physicians from various localities in Pennsylvania.
These physicians are concerned about the NRC's proposals to revise conditions relating to medical use of radioisotopes.
Any information your office could provide regarding this matter would be greatly appreciated.
For your convenience, my office vould be happy to forward a generalized response to each constituent.
a sample of the typical correspondence my office has received is enclosed for your review.
The staff contact for this referral is Katie Rode who can be reached at (202)224-5159.
Thank you for your assistance.
Si ~ rely, 7
Rick Santorum Uniteri States Senate RJS\\kr m
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1 NRC Revision of 10 CFR.Part 35 ISSUE The NRC is in the process of revising Part 35 of the Code of Federal
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Regulations relating to the medical use of radioisotopes. The ACR is concerned about some of the changes being proposed for this revision.
The ACR believes that some changes can be made to adjust the regulatory burden, but, as the representative of the largest component of the regulated community, we are concerned about the extent of the draft proposal.
ACTION REQUESTED Please ask your Representative and Senators to:
i Send a letter to the Chair of th'e NRC (draft to be provided at the State Chapter Meeting) concerning the prospect that proposed changes in the~ NRC Medical Use Program proposal mayjeopardize patient care and create a situation where incidents that are deleterious to patient care will begin to occur with greater frequency than occur today. 'Ihe ACR comments on the draft supported the concept that some
' relaxation of the training and experience requirements might be
' appropriate. However, the comments expressed the view that shortening the Training and Experience requirements for the diagnostic use of radioisotopes beyond those recommended by the ACR may result in compromises in patient care (copy of ACR comments enclosed).
Background
The. Nuclear Regulatory Commission (NRC) has been undertaking for the last four years a review ofits Part 35 regulations covering the medical use of byproduct materials.' This has included an internal NRC management review, an independent external review by the National Academy of Sciences' Institute of Medicine (IOM), and is part of the NRC's current " Strategic Assessment and Rebaselining Initiative." As a result of these studies, the NRC has concluded that it should restructure its Part 35 regulations to be " risk-informed and more performance-based."
L More recently, the NRC released at the end of January a "strawman i
draft" to revise the Part 35 regulations. Although there are many changes in the draft from what currently exists in regulation, the College's comments primarily focused on proposed changes to the training and I
experience requirements for non-American Board of Radiology (ABR) physicians who wish to become NRC authorized users ofisotopes for medical purposes.
In brief, the NRC draft proffers substantial reductions in the training and experience requirements from the current regulations. It appears that the general intent of the NRC 'strawman' proposal is to separate the training and experience requirements necessary for radiation safety protection from those necessary for proper clinical performance.
The 'strawman' draft was reviewed at the March meeting of the NRC's Advisory Committee on the Medical Use ofIsotopes (ACMUI). The ACR submitted written comments arguing against the major reductions proposed in the NRC draft. The College comments recommended retention of the status quo in the areas of most risk, i.e. sources used in oncology, and advocated a middle ground between the cuiTent requirement and the NRC draft in the ' lower risk' area. In addition, Dr.
Frank Wilson, a radiation oncologist from the Medical College of Wisconsin, represented ACR at the ACMUI meeting and addressed issues related to radiation oncology. Dr. Larry Holder from Johns Hopkins University addressed the diagnostic nuclear medicine related issues.
The Committee accepted the status quo position in the areas of sources used in radiation oncology, and recommended to the NRC that they essentially retain the current requirements for use of those types of sources. The key argument seemed to be that, in the area of oncology, the hazards are so great from the sources used that it is impossible to separate radiation protection training from clinical training. However, the Committee did not make this same distinction in the diagnostic area.
They accepted the NRC draft position for sources used in diagnostic nuclear medicine, and recommended that the NRC draft requirements of 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> of clas coom training and 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of experience be adopted as the NRC proposal.
The NRC staffis currently considering the advice of the ACMUI and will make recommendations to the NRC Commissioners at their scheduled May meeting. It is anticipated that a proposed rule to revise Part 35 will be published some time this summer. ACR will be actively monitoring the NRC's activities and will keep the radiology community apprised of the developments in any proposed revisions to the Part 35 regulations.
Your help at this meeting, by contacting your elected representatives, will enhance the ACR's efforts to assure that this process does not compromis patient care.
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4 Dr. Shir!ey Ann Jackson, Chairman U.S. Nuclear Regulatory Commission One White Flint North 11555 Rockville Pike Rockville, Maryland 20 M 2738
Dear Dr. Jackson,
I understand that the Nuclear Regulatory Commission (NRC) is undergoing a process of revising its regulations to be more risk-based and performance oriented. The part of this process
. that is of concern to me involves revision of 10 CFR Part 35, which applies to the medical use of radioisotopes. While I support the direction in which the commission is moving, some of my constituents in the radiology community are concerned about the trend that is reflected in early drafts of the revisions of Part 35 relating to the training and experience necessary to become licensed to use radioisotopes diagnostically.
The record of safe usage of radioisotopes compiled over many years under NRC Licensure is a very good one. I and my constituents are concerned that, with the severe reductions in required training and experience under 10 CFR Part 35.100,200 and 300 that are being considered, this record of safe usage will end and more incidents that jeopardize patient care will occur. I urge you, as leader of the Commission, to consider carefully the implications of the proposal that the NRC staffis preparing for your approval. We believe that patient care would best be served if the training and experience requirements were revised as recommended in comments submitted to the NRC staffby the American College of Radiology. It would be unfortunate to move too far in a direction that jeopardizes patients in the name of a more forward looking regulatory process.
I would appreciate a letter in response from you indicating the position that you intend to take on this issue.
Sincerely, o
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David McIntosh l
Member of Congress
.y,3,3 y.q o, on Second District, Indiana I
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