ML20195K341
| ML20195K341 | |
| Person / Time | |
|---|---|
| Issue date: | 11/24/1998 |
| From: | Hoyle J NRC OFFICE OF THE SECRETARY (SECY) |
| To: | Dinger K HEALTH PHYSICS SOCIETY |
| References | |
| FRN-63FR43516, RULE-PR-20, RULE-PR-32, RULE-PR-35 NUDOCS 9811250232 | |
| Download: ML20195K341 (1) | |
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November 24, 1998 W NOV 25 Pl2:05 SECRETARY Of i -
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Mr. Keith H. Dinger President, Health Physics Society 00CKET NUMBEb Executive Offices, Suite 402 DD 1313 Dolley Madison Blvd.
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Dear Mr. Dinger:
I am responding to your letter dated November 6,1998, requesting a 60-day extension of the comment period, as a minimum, for the proposed rule, which would amend the regulations in 10 CFR Part 35, " Medical Use of Byproduct Material," to allow time for the Health Physics Society to develop consensus comments.
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 Commissioq 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, b
John C. Ifoyle
Enclosure:
11/13/98 Staff Requirements Memorandum 1
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Sovember 13, 1998 OFFICE oF THE SECRETARY MEMORANDUM TO:
William D. Travers Exec ti Di ctor for Operations rNb W
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Jo
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SUBJECT:
AFF REQUIREMENTS - SECY-98-262 - PROPOSED RULE:
REVISION OF 10 CFR PART 35, MEDICAL USE OF BYPRODUCT MA fERIAL The Commission has approved Option 2B 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 onginal 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 Dicus's office:
JoelLubenau Commissioner Diaz's office:
Patrick Castleman Commissioner McGaffigan's office: Janet Schlueter Commissioner Merrifield's office:
Lynne Stauss The staff should continue to follow established procedures for developing and promulgating rulemakings.
Enclosure S*fl
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Chairman Jackson Commissioner Dicus Commissioner Diaz Commissioner McGaffigan Commissioner Merrifield OGC CIO CFO OCA OlG OPA Office Directors, Regions, ACRS, ACNW, ASLBP (via E-Mail)
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Specialists in Radiation Safety KEITIl II. DINGER, CIIP President 1998 - 1999 November 6,1998 Executive omces, suite 402 1313 Dolley Madisen Blvd.
The Honorable Shirley Jackson McLean, Virginia 22101 Chairman Tel: (703) 790-1745 U. S. Nuclear Regulatory Commission Fax: (703) 790-2672 E-Mail: hps@kirkinc.com Washington, DC 20555 RE:
Request for Extension of Comment Period; 63 Fed. Reg. 43516 (August 13,1998); RIN 3150-AF74
Dear Chairman Jackson:
On behalf of the members of the Health Physics Society, I request the Commission extend the comment period for the referenced proposed revision of its regulations governing the medical use of byproduct material. I request this extension be for a minimum of sixty (60) days beyond the currently established expiration date of November 12,1998.
The Health Physics Society views 10 CFR Part 35 as an extremely important regulation providing the standards of safety to be used in the beneficial application of radiation and radioactive materials in medicine. Accordingly, the Society has established an Ad Hoc Committee specifically tasked with being i
involved in the development of revisions to this regulation. The Committee is actively developing comments on the proposed revision. However, due to the c'u Ey M.cf extensive nature of the proposed changes it is impossible to develop consensus comments in the time frame of the current comment period.
-] fot 93 L; 43 The Health Physics Society's interest in these regulations is somewhat unique in that we can not simply review and comment on a specialized or selected area of the regulations, but rather we must view it from a holistic standpoint. As radiation safety professionals providing the safety program implementation and oversight in medical facilities, our interest and responsibilities span the entire construct of the rule. This broad area of interest results in the need for considerable time and effort to develop responsible, and useful comments. Our desire is to provide constructive comments in line with the stated intent for this revision to be risk-informed and more performance-based, something we feel is not reflected in the current proposal. We are interested in assisting the Commission in improving the proposed rule, not in simply identifying items or areas we consider unacceptable. However, the development of constructive comments takes time not available in the current comment period.
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'n I look forward to a favorable decision on this request, reflecting the Commission's commitment to develop a quality regulation that provides appropriate protection for the safety and health of the public rather than one that meets an arbitrary scheduled issue date.
Please feel free to contact me if I can be of further help in this important matter.
Sincerely,
\\M S.s Keith H. Dinger, CHP President cc:
The Honorable Greta Joy Dicus, Commissioner The Honorable Nils J. Diaz, Commissioner The Honorable Edward McGaffigan, Jr., Commissioner The Honorable Jeffrey Merrifield, Commissioner Dr. William D. Travers, Executive Director for Operations Hugh L. Thompson, Jr., Deputy Executive Director Dr. Carl J. Paperiello, Director - NMSS
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