ML20236Q272

Meeting Minutes Re NEI & Council of Radiopharmaceuticals, Inc to Discuss Process Being Used to Revise 10CFR35, Medical Use of Byproduct Matl

ML20236Q272
Person / Time
Issue date:	06/04/1998
From:	NRC
To:	NRC
References
NUDOCS 9807200126
Download: ML20236Q272 (3)

Text

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Attendees PUBUC DOCUMENT ROOM ]

Industry "

Mark Doruff, Council on Radionuclides and Radiopharmaceuticals, Inc.

Jim Massie, Alpine Group, Inc.  !

Roy Brown, Mallinkrodt. Inc.

Felix M. Killar, Jr., Nuclear Energy Institute S l Mal Knapp Don Cool Fred Combs Josie Piccone Cathy Haney Backaround and Purpose Mr. Killar, Nuclear Energy Institute (NEI), requested a meeting with the NMSS Office Director on behalf of NEl and the Council on Radionuclides and Radiopharmaceuticals, Inc. (CORAR),

to discuss the process being used to revise 10 CFR Part 35, " Medical Use of Byproduct Material.'* The meeting was held as a public meeting announced on the NRC Bulletin Board.

DiscussiQD Mr. Knapp, NRC, opened the meeting by welcoming the meeting attendeec then turned the meeting over to Mr. Killar.

Mr. Killar remarked that the Part 35 revision process began favorably; however, he now believes that the process has gone " astray." He does not believe the public received adequate t feedback from NRC regarding the rulemaking. In partcular, he feels NRC has not addressed several concerns raised at the facilitated public meetings. He believes that the workshops were g!

a good way for the public to provide NRC comments on the rulemaking; however, he believes j the staff was unable to incorporate many of the suggestions made by the meeting attendees due to the production schedule of the rule. /u g

Mr. Killar also expressed concern regarding use of the Part 35 website. He believes that during the initial phases of the rulemaking process NRC staff effectively used the website to

, communicate with the public; however, since January, he believes, public communication has significantly decreased.

- Mr. Massie of Alpine Group, Inc. and Mr. Brown of Mallinkrodt, Inc. remarked they would like to see the Part 35 revision process "get back on track." They think NRC should work toward deemphasing low-risk medical activities.

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2 Mr. Brown indicated that the NRC did not appear to follow the current Medical Policy Statement when developing rules, and it may not be appropriate to revise the policy statement at this time.

He is also concerned that sufficient time has not been allocated for revising C o rule.

Mr. Massie indicated that, in general, CORAR was supportive of NRC; however, they are concerned that NRC regulations may adversely effect use of radiopharmaceuticals. He is concemed that the regulations may have negative economical implications in this area of medicine.

Mr. Knapp stated the rulemaking timeframe was established by the NRC Commission and the - 1 Commission is very interested in working with the meeting participants to improve the process.

Mr. Knapp requested the attendees to provide him with ideas for making improvements to the process.

Mr. Knapp inquired whether meeting attendees would like to see more documents placed on the website, and in particular, comments on the rule. Dr. Cool stated that written comments were not currently available on the website. Mr. Knapp indicated that staff would investigate the feasibility of placing all comment letters on ihe website. This would involve a process of l scanning the letters to obtain an electronic file that would then be placed on the website. Mr.

Knapp noted that the resources that would be involved in this effort could be a factor.

Mr. Massie indicated that the draft rule text ("strawman") did not reflect what was said at the i facilitated public meetings. He questioned why NRC had not incorporated many of the  !

comments received at the meetings. Mr. Brown offered an example of where comments I provided at the facilitated public meetings had not been incorporated into the rule structure and ]

staff had not explained the rationale for excluding the comments. He referenced comments - ]

that supported use of a general license to regulate diagnostic uses of materials rather than a specific license.--  ;

Mr. Doruff, CORAR, stated that he found the workshops, conducted as part of the -l

' decommissioning rulemaking, to be very effective. . Mr. Massie indicated that CORAR was in i favor of recent efforts made by the FDA to involve the public in regulatory matters (rulemaking).  :

Mr. Knapp explained that significant time and staff effort had been devoted to the decommissioning rulemaking. Mr. Knapp also explained it was not possible to handle Part 35 in l the same manner because of the schedule and tight timeframe associated with this rulemaking. ,

He did, however, state that he understood CORAR's concems and wanted to work towards better communication with the public.

Mr. Killar indicated that he agreed with the concept of using electronic media as one means for increasing communication. He did not believe that all comment letters needed to be placed on the website and c*fered that NRC staff could paraphrase the comment letter and then place only the paraphrased text on the website. l Mr. Knapp prefers the comment letters not be paraphrased because of the potential for inaccurate interpretation. He committed to determining, in consult with the Office of the  ;

' General Counsel, if rule text could be made electronically available to the public. He also

. committed to informing the Office of the Executive Director for Operations of the NEl/CORAR L-___-_-__________ _ _ _ _ _ _ _

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concerns.

1 Mr. Doruff questioned how NRC would validate comments. He asked whether there was a mechanism available for NRC to request additional information from the commenter. Mr.

Knapp indicated that staff would prefer to use an interactive process for resolving public comments.

Mr. Killar questioned the relationship between the questionnaire developed by Scientech and placed on the INTERNET and the NRC. He did not think that the survey was clearly worded -

and recommended that the questionnaire be revised to clearly state what information was being requested. _ Dr. Cool indicated that the Scientech questionnaire is part of an NRC effort to identify / review risks associated with uses of byproduct material in the materials area. He indicated that this project is scheduled for completion the end of calendar year 1998. Mr.

Knapp indicated that he would look into the content of the questionnaire.

Mr. Knapp asked if NEl/CORAR would be interested in a follow up meeting in July to discuss the NEl/CORAR initial views on the proposed rule. Mr. Knapp did indicate that he would need to confer with OGC to confirm that a meeting of this type would not adversely effect the rulemaking process. Allindustry attendees were in favor of the meeting.

,Mr. Killar asked if there was anything that NEl/CORAR could do to help the process and offered to electronically submit the NEl comments on the rule. Ms. Haney suggested NEl/CORAR

- periodically contact her to inquire about the status of the rulemaking efforts.

Summarv of Commitments Mr. Knapp:

1. Investigate the feasibility of placing all comment letters on the website.

2. Determine, in consult with the Office of the General Counsel, if rule text could be made electronically available to the public on the website.

3. Inform the Office of the Executive Director for Operations of the NEl/CORAR concerns.

4. Review the content of the Scientech questionnaire.

5. Confer wd OGC to determine if a follow up meeting could be held to discuss NEl/CORAR's initial comments on the staff's proposed rule.