ML20217Q921
| ML20217Q921 | |
| Person / Time | |
|---|---|
| Issue date: | 04/30/1998 |
| From: | Shirley Ann Jackson, The Chairman NRC COMMISSION (OCM) |
| To: | Coverdell P, Danner P, Hefley J, Knollenberg J, Nethercutt G, Pastor E, Portman R, Sanchez L, Watts J HOUSE OF REP., SENATE |
| Shared Package | |
| ML20217Q924 | List: |
| References | |
| FRN-62FR42219, RULE-PR-35 NUDOCS 9805130026 | |
| Download: ML20217Q921 (9) | |
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UNITED STATES NUCLEAR REGULATORY COMMISSION e'
e WASHINGTON, D.C. 20555-0001 e
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1 CHAIRMAN The Honorable Joel Hefley United States House of Representatives j
Washington, D.C. 20515
Dear Congressman Hefley:
1 I am responding to your letter dated March 31,1998, where you expressed reservations about possible changes in the U.S. Nuclear Regulatory Commission's (NRC's) 10 CFR Part 35 l
regulations on medical use of byproduct material. In particular, you were concerned about the training and experience requirements 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 1
comments received during these interactions, in preparing the proposal. After Commission approval, a proposed rule will be published in the Eederal Reaister for public comment. We expect to hold additional pub;ic 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 the 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 i
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 public commenters, that NRC requirements sometimes intrude into the practice of medicine.
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The Commission will carefully consider the staff proposalin light of public comments such as yours when it is received. The results of that consideration will then be available for additional public comment and discussion.
nft/m Sincerely,
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9805130026 990430 Shirley Ann Jackson PDR COMMS NRCC CORRESPONDENCE PDR Q,.o!
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WASHINGTON, D.C. 20555-0001 April 30, 1998 CHAIRMAN The Honorable Loretta Sanchez United States House of Representatives Washington, D.C. 20515
Dear Congresswoman Sanchez:
I am responding to your letter dated April 2,1998, where you expressed reservations about possible changes in the U.S. Nuclear Regulatory Commission's (NRC's) 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 personnel involved in diagnostic and therapeutic uses of unsealed byproduct material.
The NRC staff is scheduled to provide us 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 the 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 public commenters, that NRC requirements sometimes intrude into the practice of medicine.
The Commission will carefully consider the staff proposal in light of public 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 1
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WASHINGTON. D.C. 20555-0001 i
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e April 30, 1998 CHAIRMAN l
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i The Honorable Pat Danner United States House of Representatives j
Washington, D.C. 20515 l
Dear Congresswoman Danner:
I am responding to your letter dated March 31,1998, where you expressed reservations about possible changes in the U.S. Nuclear Regulatory Commission's (NRC's) 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 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
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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 the 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 public commenters, that NRC requirements sometimes intrude into the practice of medicine.
J The Commission will carefully consider the staff proposal in light of public 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 l
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,o April 30, 1998 CHAIRMAN The Honorable J.C. Watts, Jr.
United States House of Representatives Washington, D.C. 20515
Dear Congressman Watts:
l am responding to your letter dated March 31,1998, where you expressed reservations about possible changes in the U.S. Nuclear Regulatory Commission's (NRC's) 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 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 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 j
comments both supporting reduction in requirements affecting personnelin the diagnostic area, including the American College of Cardiology and the American Society of Nuclear i
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 public commenters, that NRC requirements sometimes intrude into the practice of medicine.
The Commission will carefully consider the staff proposal in light of public comments such as yours when it is received. The results of that consideration will then be available for additiona!
public comment and discussion.
Sincerely, Shirley Ann Jackson 5
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UNITED STATES NUCLEAR REGULATORY COMMISSION f.
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April 30, 1998
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CHAIRMAN The Honorable Ed Pastor United States House of Representatives Washington, D.C. 20515
Dear Congressman Pastor:
I am responding to your letter dated March 31,1998, where you expressed reservations about possible changes in the U.S. Nuclear Regulatory Commission's (NRC's) 10 CFR Part 35 regulations on medical use of byproduct material. In particular, you were concemed about the training and experience requirements 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 Amencan College of Radiology); and the posting of a "strawman" rule text on the Internet for cominents. 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 personnelin the diagnostic area, including the 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 public commenters, that NRC requirements sometimes intrude into the practice of medicine.
The Commission will carefully consider the staff proposalin light of public 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
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April 30, 1998 CHAlsf4AN The Honorable Joe Knollenberg United States House of Representatives Washington, D.C. 20515
Dear Congressman Knollenberg:
I am responding to your letter dated April 3,1998, where you expressed reservations about possible changes in the U.S. Nuclear Regulatory Commission's (NRC's) 10 CFR Part 35 regulations on medical use of byproduct material in particular, you were concemed about the training and experience requirements that would be applicable to personnel involved in i
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 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 the 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 public commenters, that NRC requirements sometimes intrude into the practice of medicine.
The Commission will carefully consider the staff proposal in light of public 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
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o April 30, 1998 CHAIRMAN l
l The Honorable Rob Portman l
United States House of Representatives I
Washington, D.C. 20515 l
Dear Congressman Portman:
I am responding to your letter dated April 9,1998, where you expressed reservations about possible changes in the U.S. Nuclear Regulatory Commission's (NRC's) 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 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 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 the 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 public commenters, that NRC requirements sometimes intrude into the practice of medicine.
The Commission will carefully consider the staff proposalin light of public comments such as yours when it is received. The results of tha' consideration will then be available for additional public comment and discussion.
Sincerely, k
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UNITED STATES
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April 30, 1998 CHA:RMAN The Honorable Paul D. Coverdell United States Senate Washington, D.C. 20510
Dear Senator Coverdell:
I am responding to your letter dated April 13,1998, regarding the concerns of your constituent, Dr. Lee Martin, Jr. Dr. Martin expressed reservations about possible changes in the U.S.
Nuclear Regulatory Commission's (NRC's) 10 CFR Part 35 regulations on medical use of byproduct material. In particular, he was concerned about the training and experience requirements that would be applicable to personnelinvolved in the medical uses of unsealed byproduct material.
The NRC staff is scheduled to provide its recommendations on proposed revisions to Part 35 to the Commission ir. 'une 1998. The proposed rule is being developed using an increased public participation process that included public workshops; meetings with varixs 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 Reoister 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 th;s issue have varied. The Commission has received comments both supporting reduction in requirements affecting personnel in the diagnostic area, including the 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 ccmpetency 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 public comm oters, that NRC requirements sometimes intrude into the practice of medicine.
The Commission will carefully consider the staff proposal in light of public comments such as your constituent's when it is received. The results of that consideration will then be available for additional public comment and discussion.
Sincerely, bC Shirley Ann Jackson l
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April 30, 1998 CHAIRMAN The Honorable George R. Nethercutt, Jr.
United States House of Representatives Washington, D.C. 20515
Dear Cengressman Nethercutt:
I am responding to your letter dated April 14,1998, where you expressed reservations about possible changes in the U.S. Nuclear Regulatory Commission's (NRC's) 10 CFR Part 35 reguiations on medical use of byproduct material. In particular, you were concerned about the
. training and experience requirements that would be applicable 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 personnelin the diagnostic area, including the American College of Cardiology and the American Society of Nuclear Cardiologists, and favoring keeping the presently existing requirements. The staff draft, while i
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 public commenters, that NRC requirements sometimes intrude into the practice of medicine.
The Commission will carefully consider the staff proposal in light of public comments such as
. yours when it is received. The results of that consideration will then be available for additional public comment and discussion.
Sincerely,
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i Ms. Shirley Ann Jackson Chairman U.S. Nuclear Regulatory Commission One White Flint North I
11555 Rockville Pike Rockville, Maryland 20852-2738
Dear Chairman Jackson:
I understand that the Nuclear Regulatory Commission is undergoing a process of revising its regulations to be more risk-based and performance oriented.
The part of this process that is J
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 j
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 j
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 carefully consider the implications of the proposal that would best be served if the training and experience requirements were revised l
I as recommended in comments submitted to the NRC staff by the America:. College of Radiology.
It certainly would bc. unfortunate to move too far in a direction that jeopardizes patients in the name of a more forward looking regulatory process.
Thank you for your attention to this important matter.
With best regards, Sincerely, l
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%)01150 0{ l$0pr0Stillatibts April 2,1998 MI,1shmgton, DC 20313-0340 Dr. Shirley Ann Jackson, Chairman U.S. Nuclear Regulatory Commission One White Flint North 11555 Rockville Pike Rockville, MD 20852-2738 Dear Chairman Jackson.
I understand that the Nuclear Regulatory Commission (NRC) is undergoing a procsss of revising its regulations to be more risk-based and perfbrmance 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 reDected in early drans 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 am 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.
1 urge you, as leader of the Commission, to consider carefully the implications of the proposal that the NRC stafris preparing fbr yoar approval. We believe that patient care would best be served if j
the training and experience requirements were revised and recommended in comments submitted to the NRC stairby the American College of Radiology (copy attached). It would be unfortunate to move too far in a direction that jeopardizes patients in the name of a more fbrward looking regulatory process.
Thank your fbr your attention to this matter. I look thrward to hearing from you.
Very Truly Yours, Loretta Sanchez Member of Congress PH.NTE D L N 846 < J5{ D @Aff P
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MQSA Reauthorization ISSUE The Mammography Quality Standards Act (MQSA) of 1992 will need to be reauthorized this year. The ACR supports reauthorization of this important law with amendments to enhance the quality for the early detection of breast cancer nationwide.
ACTION REQUESTED Please ask your Representative and Senators to:
Support MQSA uauthorization legislation that will enhance the quality and cost-effectiveness of this national standard for mammography facilities. The ACR believes that amendments to MQSA should include:
+ Demonstration projects to improve the quality, reduce duplication of effort, and advance the cost-effectiveness of mammography facility inspections.
+ Technical changes to preserve the integrity and quality of the clinicalimage review process.
+ Providing directly to every patient a summary of the radiologist's findings from the mammogram in terms easily understood by a lay person.
BACKGROUND Since enactment of the Mammography Quality Assurance Standards Act (MQSA)in 1992, women in the U.S. have gained confidence in the providers of their mammograms, through the knowledge that mammography facilities were being certified in accordance with federal standards. The successful collaboration of radiologists, mammography facility operators, and federal and state regulators, which was carefully designed into the law, has produced significant improvements in the quality of mammograms nationwide. The federal standards are built on the ACR Mammography Accreditation Program that was established in 1987.
Reauthorization of MQSA provides an opportunity to review the Act's progress to date, as well as the implications of the overall program. Issues raised during the initial implementation process, during the public comment period, and at public meetings of the National Mammography Quality Assurance Advisory Committee (NMQACC) reflect concerns that the inspection program has not been implemented in the most cost-effective way, taking into account past performance of facilities.
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MQSA Reauthorization,page 2 To that end,it is recommended that FDA conduct demonstration projects that carefully examine the relationship between the duration and/or frequency of on-site inspections and the quality standards established in MQSA so that facilities are not subject to inefficient, duplicative or excessive oversight. The projects should examine the practices of facilities that demonstrate consistently high levels of performance on annual on-site inspections. In addition, two technical changes are recommended to j
strengthen the statute to assure the objectivity and quality of the review of clinical i
images. We believe that these modifications will help to preserve the integrity of the clinical image review process.
With regard to notification of mammography results, the Agency for Health Care Policy Research (AHCPR) strongly recommended that both women and their referring physicians be directly notified of the results of mammograms. Currently, under MQSA, results are sent directly to women who are not referred by a primary care physician (self-referral). However, an increasing number of mammography facilities have begun to report both normal and abnormal findings directly to the woman, as well as her referring physician. We recommend that all facilities be required to provide results in lay language directly to all women after mammography so long as relationships with referring physician are not disrupted.
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Dr. Shirley Ann Jackson, Chairman u sU$$e2!%
uM21s's1 U.S. Nuclear Regulatory Commission One White Flint North 11555 Rockville Pike Rockville, MD 20852-2738
Dear Chairman Jackson:
I would like to take this opportunity to express to yau my concerns with regard to the training and experience requirements to become licensed to use radioisotopes diagnostically.
As the Nuclear Regulatory Commission (NRC) is undergoing a process of revising its regulations to be more risk-based and performance oriented, the revision of 10 CFR Part 35 is becoming of great concern to several of my constituents. Members of the radiology community in my district 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
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diagnostically.
Specifically, 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, the record of safe usage experienced under the current NRC licensure requirements may end. I request that you give your utmost consideration to the possible implications of the proposal that the NRC staffis preparing for your approval and, in turn, give the same consideration to the training and experience requirements as revised and recommended in comments submitted to NRC staff by the American College of Radiology. It would be most unfortunate to adopt revisions thatjeopardizes patient care in the name of a more forward looking regulatory process.
j Thank you for giving my concerns your timely consideration. I look forward to hearing from you soon on this issue.
1 Best regards.
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u a March 31,1998 o.w.. -.. c Dr. Shirley Ann Jackson, Chairman U. S. Nuclear Regulatory Commission One White Flint North 11555 Rockville Pike Rockville, MD 20852-2738
Dear Chairman Jackson:
I understand that the Nuclear Regulatory Commission (NRC) is revising its regulations to be more risk-based and performance oriented. Although I applaud this process, I am seriously concerned about revision of 10 CFR Part 35, which applies to medical use of radioisotopes.
Early drafts for the revision of Part 35 relating to the training and experience necessary to become licensed to use radioisotopes diagnostically are strongly opposed by the experts from the medical radiology community, those with the greatest experience and knowledge in this area.
The NRC has an admirable record for overseeing the safe usage of radioisotopes. The severe reductions in required training and experience under 10 CFR Part 35.100,200, and 300 that are being considered portends an end to this safe record, and most importantly increased risk to patient safety and well being. First, we must do no harm.
1 In the interest of optimum patient care, I urge you to strongly consider the training and experience recommendations submitted to your staff by the American College of Radiology. I would be unfortunate to move too far in the direction that jeopardizes patients in the name of a more forward looking regulatory progress. I look forward to your response on this issue.
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.E)01150 Of l$0prfstillattbrS March 31.1998 Dr. Shirley Ann Jackson Chairwoman U.S. Nuclear Regulatory Commission One White Flint North 11555 Rockville Pike Rockville, Maryland 20852-2738
Dear Chairwomrm Jachen:
I understand that the Nuclear Regulateny 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 revisions 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 j
licensed to use radioisotopes diagnostically.
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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
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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 staff by the American College of Radiology (copy enclosed). While I support the new direction in which the Commission is moving, I await your response to my concern for patient care in light of the proposed reductions in training and experience requirements for licensing workers in radiology.
If you have any questions please da not hesitate to call Selena Walsh of my staff at (202) 225-4065.
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Ed Pastor Member of Congress EP:sw encl.: NRC revision, MQSA reauthorization
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NRC Revision of 10 CFR Part 35 ISSUE
' The NRC is in the process of revising Part 35 of the Code of Federal 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:
Send a letter to the Chair of the 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
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and create a situation where incidents that are deleterious to patient i
care will begin to occur with greater frequency than occur today. The 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 Regulmtory Commission (NRC) has been undertaking for the i
last four years a review ofits Part 35 regulations covering the medical use of byproduct materials. This has included an internal NRC j
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 l
result of these studies, the NRC has concluded that it should restmeture its Part 35 regulations to be " risk-informed and more performance-based."-
More recently, the NRC released at the end of January a 'strawman 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 9
experience requirements for non-American Board of Radiology (ABR) physicians who wish to become NRC authorized users of isotopes 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 current requirement and the NRC draft in the ' lower risk' area. In addition, Dr.
Frank Wilson, a radiation oncologist from the Medical College of
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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 t
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 classr-om 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 compromise patient care.
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ra..,%'E ui 4m4 Hiasfjington, BC 20515-2211 EmoJTO".",'Amoo~s 248-esi.13ee April 3,1998 COMMITTEE oN STANDARDS OF is4n unania OFFICIAL CONDUCT L'vomia. MI 48154 734-425-7567 Paul F. Welday c,uu OP sw, Dr. Shirley Ann Jackson U.S. Nuclear Regulatory Commission One White Flint North 11555 Rockville Pike Rockville, Maryland 20852
Dear Chairman 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. In particular, I am concerned about the revision of 10 CFR Part 35, which applies to the medical use of radioisotopes. I support the direction in which the commission is moving. However, some of my constituents in the radiology community are concerned about provisions in the early drafts of the j
revisions of part 35 relating to the training and experience necessary to become licensed to use j
radioisotopes diagnostically.
The record of safe use of radioisotopes compiled over many years under NRC licensure is a very good one. My constituents are concerned that, with the severe reductions in required training and experience being considered under 10 CFR Part 35.100,200, and 300, this record of safe use will end and the incidents jeopardizing patient care will increase. I urge you, as leader of the Commission, to carefully consider the implications of this proposal. Training and experience requirements should be revised in a manner that best impacts patient care. It would be unfortunate to move too far in a direction that jeopardizes patients in the name of a more forward-looking regulatory process.
Thank you for taking the time to hear my thoughts. If you have any questions or comments, please do not hesitate to contact me.
Sincerely, Joe Knollenberg Member of Congress JKK:ab PR8NTID ON #6CYCLEO PAFER L
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