ML20195K443
| ML20195K443 | |
| Person / Time | |
|---|---|
| Issue date: | 11/24/1998 |
| From: | Hoyle J NRC OFFICE OF THE SECRETARY (SECY) |
| To: | Nichols D AMERICAN COLLEGE OF NUCLEAR PHYSICIANS |
| References | |
| FRN-63FR43516, RULE-PR-20, RULE-PR-32, RULE-PR-35 NUDOCS 9811270017 | |
| Download: ML20195K443 (1) | |
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,[ % UNITED STATES
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%, ,/ November 24, 1998 SECRETARY W ND'.' 25 Pl2 :05 J Oii-Rat -
ADJL".A , 7p Mr. David Nichols Director of Government Relations DOCKET NUMBER
- American College of Nuclear Physicians /
Society of Nuclear Medicine oR0 POSED RULE PR acauar 1850 Samuel Morse Drive ( c.3 FRyggfg Reston,VA 20190
Dear Mr. Nichols:
I am responding to a letter dated October 30,1998, that was jointly sigr M by: the American College of Nuclear Physicians; Society of Nuclear Medicine; American Col'ege of Radiology; Council on Radionuclides and Radiopharmaceuticals; Nuclear Energy Institute; National Electrical Manufacturers Association; American College of Nuclear Medic lne; and American Association of Physicists in Medicine. These aforementioned organizations requested: 1) an immediate extension of the comment period for the proposed rule, which would amend the regulations in 10 CFR Part 35," Medical Use of Byproduct Material," to allow for the
~ development of the risk analysis and the rule, and 2) an extension of the implementation date
', , for the final rule.
On November 13,1998, via a Staff Requirements Memorandum (enclosed), the Commission approved a 30-day extension of the public comment period and the final rule date. On November 23,1998, the Commission announced in the Federal Reaister (63 FR 64829) that
. the comment period has been reopened until Wednesday, December 16,1998. In addition, the staff will provide a discussion on the need for future risk assessment in this area, when the final
. rule is forwarded to the Commission for approval.
Sincerely, John C. oyle
Enclosure:
11/13/98 Staff Requirements Memorandum
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UNITED STATES l "f " ' NUCLE AR REGULATORY COMMISSION
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%,...../ Sovember 13, 1998 l OFFICE OF THE j SECRETARY l
MEMORANDUM TO: William D. Travers f Di ctor for Operations Exec ti b
FROM: . H yl ,' ecretary Jo/
SUBJECT:
AFF REQUIREMENTS - SECY-98-263 - PROPOSED RULE:
REVISION OF 10 CFR PART 35, MEDICAL USE OF l BYPRODUCT MATERIAL The Commission has approved Option 28 to allow for a 30 day extension of the public comment period and the final rule date. While the extension of the final rule date is to ensure meaningful discussion with the ACMUI can be accomplished, the staff should seek to complete as much work as possible in parallel in order to attempt to meet the original due date. In addition, when the proposed final rule is submitted to the Commission, the staff should include a discussion of the risk assessment as an option and provide the pros and cons for this option.
The Commissioners' offices have designated the following points of contact for work related to the Part 35 revision:
Chairman Jackson's office: James Smith Commissioner Dieus's office: JoelLubenau Commissioner Diaz's office: Patrick Castleman Commissioner McGaffigan's office: Janet Schlueter Commissioner Mernfield's office: Lynne Stauss The staff should continue to follow established procedures for developing and promulgating rulemakings.
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cc: Chairman Jackson Commissioner Dieus Commissioner Diaz Commissioner McGaffigan Commissioner Merrifield OGC ClO CFO OCA OlG OPA Office Directors, Regions. ACRS ACNW, ASLBP (via E-Mail)
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.d BY HAND October 30,1998 The Honorable Shirley Jackson Chairman U.S. Nuclear Regulatory Commission Washington, DC 20555 Re: Urgent Request for Extension of Comment Period; 63 Fed. Reg. 43516 (Aug.13,1998); RIN 3150-AF74
Dear Chairman Jackson:
The undersigned organizations are writing to request that the Commission extend the comment period for the ongoing revision of 10 C.F.R. Part 35 to allow for the development of the risk analysis and the rule accordingly, As you may have been informed by staff, it was the unanimous view of participants in the Medical Use Rulemaking Workshop held on October 21-22,1998 that there was simply insufficient time to offer meaningful comments on the proposal by the expiration of the comment period on November 12,1998. Concern was also raised that the current activity surrounding risk analysis (the uncompleted report from the Nuclear Byproduct Material Risk Review Group) is not adequate. We recognize ead appreciate that this program has involved a substantial effort by the Commission and the staf J, as evidenced by the presence of Commissioner McGaffigan and Deputy Executive Director Hugh L. Thompson, Jr at substantial portions of the workshop.
Because the regulations the Commission adopts are to be based on risk-informea performance-based criteria, per your March 20,1997 and June 30,1997 SRMs, we believe tnat the entire rulemaking extension must take into account ti.e need to conduct an appropriate risk analysir The target implementation date of any final rule should also be adjusted by a similar period of time. Because we recognize that the Commission will want to consider this issue carefully, we believe that an immediate extension should be granted.
Last week's workshop made it abundantly clear that the medical community does not believe the proposed rule adequately reflects the stakeholders concept of risk informed rulemaking nor the Commission's directive to develop risk-informed requirements. In fact, there was a strong belief that many elements of the proposed rule bear no meaningful relationship to the risk of the materials involved. We are prepared to present to the Commission a proposal that describes in detail the type of the risk analysis we believe must be performed along with an estimate of the time involved. Representatives of the medical community will be contacting your oftice to set up meetings to discuss this further.
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.k The Honorable Shirley Jackson
' October 30,1998 Page 2 We recognize that the Commission's decision to rewrite Part 35 was, in part, responsive to the medical community's discontent with the existing regulations. Despite that discontent, there appears to be a consensus that operating under the existing rules on a temporary basis, in order to
'. develop an appropriate replacement, is preferable to an incomplete and unsupported proposed regulation.
The undersigned organizations hope that you will promptly grant our request for an extension of the comment period. This will allow consideration of our proposal that describes in detail the type of the risk analysis we believe must be performed. If you have any questions or require fur:her information, please contact hir. David Nichols, Director of Government Relations for ACNP/SNM at (703) 708-9773.
Sincerely, American College of Nuclear Physicians Society of Nuclear hiedicine American College of Radiology Council on Radionuclides and Radiopharmaceuticals Nuclear Energy Institute National Electrical Manufacturers Association American College of Nuclear Medicine American Association of Physicists in Medicine cc: The Honorable Edward McGaffigan, Jr., Commissioner The Honorable Nils J. Diaz, Commissioner The Honorable Jeffrey Merrifield, Commissioner The Honorable Greta Joy Dieus, Commissioner Hugh L. Thompson, Jr., Deputy Executive Director Carl J. Paperiello, Ph.D., Director - NMSS
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