ML20236R935
| ML20236R935 | |
| Person / Time | |
|---|---|
| Issue date: | 07/14/1998 |
| From: | Shirley Ann Jackson, The Chairman NRC COMMISSION (OCM) |
| To: | Green G HOUSE OF REP. |
| References | |
| NUDOCS 9807240036 | |
| Download: ML20236R935 (7) | |
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July 14, 1998 HThompson PNorry JBlaha CHAIRMAN MKnapp, NMSS DFlack, NMSS KCyr, OGC G980393 The Honorable Gene Green ED0 r/f United States House of Representatives Washington, D.C. 20515-4329
Dear Congressman Green:
I am responding to your letter dated June 12,1998, regarding proposed revisions to 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 for the use of radioactive iodine in the diagnosis and treatment of thyroid diseases.
The NRC staff provided its recommendations on proposed revisions to Part 35 to the Commission on May 29,1998. The staff carefully considered the public input, including comments from the American Association of Clinical Endocrinologists, in preparing the J
proposal. The Commission is currently reviewing the staff's proposed revision. After Commission approval, a proposed rule will be published in the Federal Reaister for public comment. During the public comment period, public meetings will be held in San Francisco, California on August 19-20,1998, in Kansas City, Missouri on September 16-17,1998, and in j
Washington, DC on September 23-24,1998. Additional details on the public meetings will be J
published in the Endetal Reaister in July.
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 changes in requirements affecting personnel in the diagnostic area, and favoring continuance of the existing requirements. The staff draft focused 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 provlded 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 is carefully considering the staff proposalin light of public comments. The j
results of that consideration will then be available for additional public comment and discussion.
Sincerely,
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Originated by:
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The Honor:bb G:n3 Green United Statrs House of Rrpr:sent tiv:s Washington, DC 20515-4329
Dear Congressman Green:
I am responding to your letter dated June 12,1998, regarding proposed evisions to the U.S.
Nuclear Regulatory Commission's (NRC's) 10 CFR Part 35 regulation on medical use of byproduct material. In particular, you were concemed about the tr ing and experience requirements for the use of radioactive lodine in the diagnosis a treatment of thyroid diseases.
The NRC staff provided its recommendations on proposed r visions to Part 35 to the Commission on May 29,1998. The staff carefully conside d the public input, including comments from the American Association of Clinical E ocrinologists, in preparing the proposal. The Commission is currently reviewing the taff's proposed revision. After Commission approval, a proposed rule will be pubi' ed in the FederalReaister for public comment. During the public comment period, p ic meetings will be held in San Francisco, California on August 19-20,1998, in Kansas C' y, Missouri on September 16-17,1998, and in Washington, DC on September 23-24,1998 Additional details on the public meetings will be published in the Federal Reaister in July.
The issue of training and experience s received the most comments during the development of the proposed rule. Viewpoints o his issue have varied. The Commission has received comments both supporting reduc ' n in requirements affecting personnelin the diagnostic area, and favoring continuance of the xisting requirements. The staff draft focused on radiation safety and proposed that per nnel competency be verified through an examination. This proposal appears to be in k ping with the direction the Commission provided to the staff namely, to develop a riskJ formed, and where appropriate, a more performance-based rule and it addressed an objectio often expressed by some commenters, that NRC requirements sometimes intruded in the practice of medicine.
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The Commission is arefully considering the staff proposalin light of public comments. The results of that con ideration will then be available for additional public comment and discussion.
Sincerely, Shirley Ann Jackson DISTRIBUTION: G980393 SECY-CRC-98-0576 NRC File Center NMSS R/F EDO r/f l
HThompson LCallan PTressler CPoland NMSS Dir. Off. r/f IMNS RF PDR: X Yes No DOCUMENT NAME:A:G980393 *SEE PREVIOUS CONCURRENCE CP/PMOOPED/ JUNE Se,1998
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Th3 Honor: bis G:ns Green Unit:d States Houss of Repres:ntatives Washington, DC 20515-4329
Dear Congressman Green:
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I am responding to your letter dated June 12,1998, regarding proposed revisions to the U.S.
Nuclear Regulatory Commission's (NRC's) 10 CFR Part 35 regulations onyddical use of byproduct material. In particular, you were concerned about the training,and experience requirements for the use of radioactive iodine in the diagnosis and treatment of thyroid diseases.
The NRC staff provided its recommendations on proposeo revigi ns to Part 35 to the Commission on May 29,1998. The staff carefully considered)he public input, including comments from the American Association of Clinical Endocpnologists, in preparing the proposal. The Commission is currently reviewing the stafs proposed revision. After Commission approval, a proposed rule will be publishedin the Federal Register for public comment. During the public comment period, public pieetings will be held in San Francisco, Califomia on August 19-20,1998, in Kansas City, Nyssouri on September 16-17,1998, and in Washington, DC on September 23-24,1998. Ad itional details on the public meetings will be published in the Federal Reaister in July.
The issue of training and experience has reptived the most comments during the development of the proposed rule. Viewpoints on this issue have varied. The Commission has received comments both supporting reduction inydquirements affecting personnel in the diagnostic area, and favoring continuance of the existi,nd requirements. The staff draft, while reducing the number of hours require ' ior certain medical modalities, also focused on radiation safety and j
proposed that personnel competency be verified through an examination. This proposal appears to be in keeping with thp' direction the Commission provided to the staff namely, to develop a risk-informed, and where apprgiiate, a more performance-based rule and it addressed an objection often/ practice of medicine.4xpressed by some commenter sometimes intruded into the
/
The Commission is carefully considering the staff proposalin light of public comments. The results of that conside ation will then be available for additional public comment and discussion.
Sincerely, Shirley Ann Jackson DISTRIBUTION: G980393 SECY-CRC 8-0576 NRC File Center NMSS R/F EDO r/f HThomps LCallan PTressler CPoland NMSS Dir. Off. r/f IMNS RF PDR:
Yes No DOCUMENT NA -:A:G980393 *SEE PREVIOUS CONCURRENCE OP/PROOPED/ JUNE 24,1990B
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.Th3 Honorebb G:ne Green United St tzs Houso of R;prcs:ntativ:s Washington, DC 20515-4329 i
Dear Congressman Green:
I am responding to your letter dated June 12,1998, regarding proposed revisions to 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 for the use of radioactive iodine in the diagnosis and treatment of thyroid
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diseases.
The NRC staff provided its recommendations on proposed revisions to Part 35 to the Commission on May 29,1998. The staff carefully considered the public input, including comments from the American Association of Clinical Endocrinologists, in preparing the proposal. The Commission is currently reviewing the staffs proposed revision. After Commission approval, a proposed rule will be published in the Federal Reaister for public comment. During the public comment period, public meetings will be held in San Francisco, California on August 19-20,1998, in Kansas City, Missouri on September 16-17,1998, and in Washington, DC on September 23-24,1998. Additional details on the public meetings will be published in the Federal Reaister in July.
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 bcth supporting reduction in requirements affecting personnel in the diagnostic area, and favoring continuance of the existing requirements. The staff draft, while reducing the number of hours required for certain medical modalities, also focused 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 i
sometimes intruded into the practice of medicine.
l The Commission is carefully considering the staff proposalin light of public comments. The results of that consideration will then be available for additional public comment and discussion.
Sincerely, Shirley Ann Jackson DISTRIBUTION: G980393 SECY-CRC-98-0576 NRC File Center NMSS R/F EDO r/f HThompson LCallan PTressler CPoland NMSS Dir. Off. r/f IMNS RF PDR:_X,_ Yes,_ No DOCUMENT NAME:A:G980393 *SEE PREVIOUS CONCURRENCE CP/ PROOFED / JUNE,1998 OFFICE RGB l
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l The Honarcbla G:n3 Green United Stat;s House of Rtpras nt:tiv:s Washington, DC 20515-4329 i
Dear Congressman Green:
/
I am responding to your letter dated June 12,1998, regarding proposed revisions to 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 for the use of radioactive iodine in the diagnosis and treatment of thyroid diseases.
/
/
The NRC staff provided its recommendations on proposed revisions to Part 35 to the Commission on May 29,1998. The staff carefully considered the public input, including comments from the American Association of Clinical Endocrinologists, in preparing the proposal. The Commission is currently reviewing the staff's proposed revision. After Commission approval, a proposed rule will be published in the Federal Reaister for public j
comment. During the public comment period, public meetings.will be held in San Francisco, California on August 19-20,1998, in Kansas City, Missouri on September 23-24,1998, and in Washington, DC on September 23-24,1998. Additional details on the public meetings will be published in the Federal Reaister in July.
/
/
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 fa' aring continuance of the existing requirements. The staff draft, while reducing the numbe f hours required for'certain medical modalities, also specified a focus on radiation safety and r posed that personnel competency be verified through an examination.
o 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.
/
1 The Commission is carefully considering the staff proposal in light of public comments. The results of that consideration will then be available for additional public comment and discussion.
/
Sincerely, Shirley Ann Jackson DISTRIBUTION: G980393 l
SECY-CRC-98-0576 NRC File Center NMSS R/F EDO r/f l
HThompson LCallan PTressler CPoland NMSS Dir. Off. r/f IMNS RF PDR: X Yes No DOCUMENT NAME:A:G980393 *SEE PREVIOUS CONCURRENCE CP/ PROOFED / JUNE,1998 M2 3/r#60 I
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FROM DUE: _06/29/98 EDO CONTROL: G980393 L
DOC DT: 06/12/98 FINAL REPLY: ry//g/pg R:pr= entative Gene Green fy TO:
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Chairman Jackson 4
FOR SIGNATURE OF :
TRAINING REQUIREMENTS FOR THE USE OF RADIOACTIVE Callan IODINE IN THE DIAGNOSIS AND TREATMENT OF THRYROID Thadani DISEASES Thompson Norry Blaha
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. DATE: 06/18/98 ASSIGNED TO:
CONTACT:
NMSS Knapp SPECIAL INSTRUCTIONS OR REMARKS:
P//M5 Action Due to NMS3 Dirptor's Offim f
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PAPER NUMBER:
CRC-98-0576 LOGGING DATE: Jun 17 98 i.
ACTION OFFICE:
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AUTHOR:
GENE GREEN, REP AFFILIATION:
U.S. HOUSE OF REPRESENTATIVES r
L ADDRESSEE:
CHAIRMAN JACKSON l
LETTER DATE:
'Jun 12 98 FILE CODE:
SUBJECT:
TRAINING REQUIREMENTS FOR THE USE OF RADIOACTIVE IODINE IN THE DIAGNOSIS AND TREATMENT OF THRYROID DISEASES ACTION:
Signature of Chairman DISTRIBUTION:
CHAIRMAN, RF t
Q SPECIAL HANDLING: OCA TO ACK CONSTITUENT:
NOTES:
OCM #13721
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DATE DUE:
Jul 1 98 SIGNATURE:
DATE SIGNED:
AFFILIATION:
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- %;"L',I" June 12,1998 Dr. Shirley Ann Jackson, Chairwoman The Nuclear Regulatory Commission One White Flint North Building, Room 17D1 11555 Rockville Pike i
Rockville, Maryland 20852
Dear Dr. Jackson:
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it has come to my attention that the American Association Clinical Endocrinologists (AACE) has recently met with members of the Commission concerning a matter related to the tmining requirements for the use of radioactive iodine in the diagnosis and treatment of thyroid diseases. Endocrinologists are the medical specialists that pioneered the use of I-131 over 50 years ago and are the physicians having primary responsibility for the care of patients with thyroid disease. They have historically completed training programs which prepare them to safely use these isotopes in clinical practice.
New proposals have suggested increasing the amount of training from 80 to 120 hours0.00139 days <br />0.0333 hours <br />1.984127e-4 weeks <br />4.566e-5 months <br /> of instniction for physicians to be licensed to use radiciodine. Endocrinologists are not seeking to expand the number of radioisotopes or alter in any way their long established techniques in managing their patients. They icel that the additional training is not necessary and will prohibit trainees and traimng programs from providing the number of medical specialists needed in the future.
Your consideration of the positions expressed by the Endocrinologists is appreciated.
The conGnued availability of cost-effective medical care is a concern of all of us and this issue will be of importance to the many individuals with thyroid gland disease.
Best Wishes, J
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l$[k ene Green Member of Congress GG:ag l
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Dr. Shirley Ann Jackson, Chairwoman The Nuclear Regulatory Commission One White Flint North Building, Room 17D1 11555 Rockville Pike Rockville, Maryland 20852
Dear Dr. Jackson:
It has come to my attention that the American Association Clinical Endocrinologists (AACE) has recently met with members of the Commission concerning a matter related to the training requirements for the use of radioactive iodine in the diagnosis and treatment of thyroid diseases. Endocrinologists are the medical specialists that pioneered the use ofI-131 over 50 years ago and are the physicians having primary responsibility for the care of patients with thyroid disease. They have historically completed training programs which prepare them to safely use these isotopes in clinical practice.
New proposals have suggested increasing the amount of training fmm 80 to 120 hours0.00139 days <br />0.0333 hours <br />1.984127e-4 weeks <br />4.566e-5 months <br /> ofinstmetion for physicians to be licensed to use radiciodine. Endocrinologists are not seeking to expand the number of radioisotopes or alter in any way their long established techniques in managing their patients. They feel that the additional training is not necessary and will prohibit trainees and traming pmgrams from providing the number of medical specialists needed in the future.
Your consideration of the positions expressed by the Endocrinologists is appreciated.
The continued availability of cost-effective medical care is a concern of all of us and this issue will be of importance to the many individuals with thymid gland disease.
Best Wish Gene Green i
Member of Congress GG:ag 2
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