ML20196E099
| ML20196E099 | |
| Person / Time | |
|---|---|
| Issue date: | 11/30/1998 |
| From: | Hoyle J NRC OFFICE OF THE SECRETARY (SECY) |
| To: | Rotman M AFFILIATION NOT ASSIGNED |
| References | |
| FRN-63FR43516, RULE-PR-20, RULE-PR-32, RULE-PR-35 NUDOCS 9812030040 | |
| Download: ML20196E099 (1) | |
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- UNITED STATES
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y NUCLEAR PEGULATORY COMMISSION g WASHINGTON. D.C. 20555-0001 DTR 18
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November 30, 1998 seen m ny DEC -1 P4:19
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Mr. Mark Rotman 8585 Mansfield Court JCPOSED RULE b< #0 M 43f ADY'I'- ,
7 ggggfg Middletown, MD 21769
Dear Mr. Rotman:
Your letter of November 20,1998, was received by the Nuclear Regulatory Commission on November 25,1998. In response to a number of similar requests for extension of the Comment period for the ' Medical Use of Byproduct Material" (10 CFR Parts 20,32 and 35) proposed rule and proposed policy statement, the Commission on November 13,1998, via a Staff Requirements Memorandum (enclosed), approved a 30-day extension of the public comment period and the final rule date. On November 23rd, the Commission announced in the Federal .;
Reaister (63 Fed. Reg. 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. ;
Your letter has been docketed as a comment on the proposed rule and proposed policy statement.
Sincerely, l< /
John C. H le
Enclosure:
As stated i
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j 9812030040 981130 PDR PR j 20 63FR43516 PDR l 35m
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-o, November 13, 1998
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OFFICE OF THE SECCETARY MEMORANDUM TO: William D. Travers Ex c ti Di ctor for Operations FROM: Job ..Hllyk ,' Secretary
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SUBJECT:
AFF REQUIREMENTS - SECY-98-263 - PROPOSED RULE:
REVISION OF 10 CFR PART 35, MEDICAL USE OF 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 ACMUl 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 datr;. In addition, when the proposed final rule is submitted to the Commission, the staff should ir clude a discussion of the risk assessment as an option and provide the pros and cons for this cation.
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: Joel Lubenau Commissioner Diaz's office: Patrick Castleman Commissioner McGaffigan's office: Janet Schlueter Commissioner Memfield's office: Lynne Stauss The staff should continue to follow established procedures for developing and promulgating rulemakings.
l Enclosure
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cc: Chairman Jackson l' Commissioner Dicus Commissioner Diaz l
Commissioner McGaffigan Commissioner Merrifield OGC ClO CFO OCA OlG
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- - 2 Ad. : N .20, 3 M 3f N l 20 Nov 98 Mark Rotman DOCpi,l[D l Board Certified Nuclear Pharmacist ijc q 1-8585 Mansfield Court Middletown, MD 21769 l f
ro ma ip net '98 ND',' 25 A 7 :40 To: Secretary, US Nuclear Regulatory Commission CF A
Re: Comments on the proposed Revisions to 10 CFR Part 35 and tWIDMedical Policy .:
Statement Dear NRC; I am writing as a practicing member of the regulated community, my comments are my own and do not necessarily reflect the opinion of my employer or anyone else. ;
I would like to complain about the sheer volume of material involved in this proposed rule making (the rule language itself, the analysis, the statement of considerations, the OMB review, the NUREG, and all the Commission correspondence) and the impossibly short time frame for review and comment. The rulemaking and associated documents comprise about 800 pages of text, yet we were given about 90 days to read, review, and compose comments, clearly an impossible task for someone who has to work full time. Because of this situation, all I will be able to comment on are general issues, and not provide any useful detailed comments. I would urge the Commission to extend the comment period for at least an additional 180 days.
I have followed the progression of this rulemaking since its inception. I was encouraged by suggestions in DSI#7, that diagnostic nuclear medicine be essentially deregulated. I was encouraged by the discussion of risk-informed, performance-based rulemaking found in dst #12. I was encouraged by the direction the Commission gave the Staff to write the proposed rule. However, I am gravely disappointed with the language of the actual rule. The proposed rule language is not in any meaningful way a deregulation of diagnostic nuclear medicine. The proposed rule language is not risk-informed nor performance based. In fact the proposed rule is highly prescriptive, and in many ways far more restrictive than the existing 10 CFR Part 35.
At various times NRC management described the how the proposed rule would start as a " blank sheet of paper", and we were encouraged to submit suggestions. At the public meetings that took place prior to the publication of the proposed rule more suggestions were requested from the public. It does not appear that the NRC took many, if any, of the publics suggestions seriously. This proposed rule is nothing more than a rehash of the existing ruh.
In order to ascertain an approximate cost for compliance with the proposed part 35 I created a spread sheet using Microsoft Excel. From my estimations, it appears that the cost for compliance for all NRC licensees (unsealed use only, and only using the proposed part 35 requirements, and where part 35 references it, part 20 requirements), will be about $100,000,000.00 for the first year. I used NRC figures for
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personnel costs, numbers of licensees, procedures, and doses. In my opinion this makes the rule profoundly expensive.
I strongly recommend that the NRC place this proposed rulemaking on hold pending the results of a risk analysis. I believe that a risk analysis will show that deregulation of diagnostic nuclear medicine is possible with no loss in protection of the public health and safety.
The Proposed Medical Policy Statement Because of the constraints of time, I am limiting my comments to #3 of the proposed MPS. I do not believe that the NRC can ever provide for the radiation safety of the ,
patient. I The term patient radiation safety (PRS)is undefined, and probably for good reason. There is no logical way in which the NRC can provide for PRS. It cannot be done with limits like part 20, or via an ALARA mechanism, because these would severely limit medical flexibility. Patients are deliberately exposed to radiation, they accept it willingly, in exchange for the medical information or therapeutic effect it .
I provides. The exposure the patient receives is the risk they take to gain the benefit of the medical procedure. In order for the benefit to be maximized the medical care provider must be adequately trained. The NRC is clearly taking steps to insure that the orders of the medical care provider be followed, but taking no steps to insure that the medical care provider is adequately trained. In my opinion, since the NRC does not demand that physicians read scans or interpret results of procedures, and since the NRC is removing all but radiation safety qualifications fcr physicians, the NRC is not interested in quality from the physicians it intends to license under the proposed part
- 35. If the NRC is not interested in quality from physicians, it cannot possibly be interested in patient radiation safety either. Therefore I suggest the NRC remove all references to patient radiation safety, and simply assert they will make regulatory efforts to insure that the physicians orders are followed.
Thank you for taking the time to read my comments.
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u Mark Rotman i
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