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1 EDO Principal Correspondence Control FROM: DUE: 12/03/02 William R. Hendee Medical College of Wisconsin EDO CONTROL: G DOC DT: 11/19/02 FINAL REPLY: TO: Chairman Meserve FOR SIGNATURE OF : Chairman Meserve DESC: Proposed Revisions in Byproduct Material" DATE: 11/21/02 ** PRI ** 10 CFR 35 "Medical Use of CRC NO: ROUTING: Travers Paperiello Kane Norry Craig Burns/Cyr ASSIGNED TO: NMSS CONTACT: Virgilio SPECIAL INSTRUCTIONS OR REMARKS: -Fp-pq I ak:. 5c-ý&q -o ill e- I bt5 SECy..o I

OF : Chairman Meserve DESC: Proposed Revisions in Byproduct Material" DATE: 11/21/02 ** PRI ** 10 CFR 35 "Medical Use of CRC

2 OFFICE OF THE SECRETARY CORRESPONDENCE CONTROL TICKET Date Printed: Nov 20, :45 PAPER NUMBER: ACTION OFFICE: LTR EDO LOGGING DATE: 11/20/2002 AUTHOR: AFFILIATION: ADDRESSEE: SUBJECT: William Hendee WI Richard Meserve Proposed revisions in 10 CFR 35 "Medical Use of Byproduct Material" ACTION: DISTRIBUTION: Signature of Chairman RF, SECY to Ack LETTER DATE: ACKNOWLEDGED SPECIAL HANDLING: NOTES: FILE LOCATION: DATE DUE: 11/19/2002 No SECY Publicly released 11/19/02 Adams 12/05/2002 DATE SIGNED: EDO -- G

"Medical Use of Byproduct Material" ACTION: DISTRIBUTION: Signature of Chairman RF, SECY to Ack LETTER DATE: ACKNOWLEDGED SPECIAL

3 Sent By: RESEARCH & TECH; ; Nov :23PM; Pace 2 November 19, 2001 MEDICAL COLLEGE OF WISCONSIN Office of Research. Tedhnoulugy and Inforrmatics 8701 Watertown PlAnk Road Milwaukee. WI Phone: 414/ FAX: 414/ whendee@mcw.edu Richard A. Meserv Chairman Nuclear Regulator3 Commission Rockville Pi '-e Rockville, MD 208 ;2 Dear Dick: I am writing you ab out concerns of the American Board of Radiology, and other certification boards including the Amer can Board of Health Physics, American Board of Science in Nuclear Medicine, and American Board of Medical Physics. regarding proposed revisions in 10CFR 35 "Medical Use of Byproduct Material On June , c ach of the certification boards above testified in Rnckville MD before a subcommittee of NRC's Advisory Committee on the Medical Use of Isotopes (ACMUI). The subcommittee was chaired by Dr. Richard Vett -r of the Mayo Clinic. At that time we strongly encouraged recognition of ccrtification by the boards, inclu ling the American Board of Radiology, as evidence of competence to serve in various capacities as descni ed in the proposed revisions. We inferred from comments and questions by the subcommittee that ý members were sympathetic to the Boards' position. Early this fall we lci irned that the subcommittee's advice to its parent committee differed from what we had inferred at the time i ýf the meeting. Although the ACMUI final recommendations have been made public, we do not know ho% Sthey correlate with options suggested by NRC staff in the options paper sent by the staff to the Commis: non In a letter to you dated October 17, 2002, the certification boards formally asked the Commission to, nake the staff options paper public. To date our request to you and the Commission remains unanswered The issue of recogni certification boards well. This issue is sc NRC Commie,%ioner evidence of compete lion by the NRC of certification by the American Board of Radiology and other ; very important to the boards. We believe it should be very important to the NRC as important that we are prepared to come to Washington to meet with you and other : to discuss it. If the staff is recommending recognition of the certification boards as rce. the trip may not be necessary. I am hoping you can answcr this question I will call you next 4eek (Tuesday or Wednesday) to discuss this issue further.. Sincerely, 63 X William R. Hendee. Ph D. Senior Associate Dc mn and Vice President cc: Robert R. I artery. M.D. Lynne Fair, >'bent B701 Watertown PlanM RcOM P0 Box Madwaucee Wisecnmin S3226-5DOY

Meserv Chairman Nuclear Regulator3 Commission 11555 Rockville Pi '-e Rockville, MD 208 ;2 Dear Dick: I am writing you ab out concerns of the American Board of Radiology, and other certification

4 Sent By: RESEARCH & TECH; ; Nov :24PM; Page 3/5 Chairman Richard A. Meserve Nuclear Regulatory C ommission One White Flint Nort i Building Rockville Pike Rockville, MD October 17, 2002 Re: Staff paper relatel to 10 CFR Pan 35 Training and Experience Requirements Dear Chairman Meacbve. On behalf of the Ame ican Board of Radiology (ABR). the American Board of Medical Physics (ABMP), the American Board c f'sclence in Nuclear Medicine (ABSNM), the American Board of Nuclear Medicinc (ABNM), and the Am,rican Board of Health Physics (ABHP), we request the Commission make the staff paper on Part 35 Trait ing and Experience options publicly available upon receipt. Based on the staff's r( :ommcndation,,e hope that we can move forward to solve the issue of deemed status for those specialty boý rds currently listed in 10 CFR Part 35 Subpart J. It is difficult to perceive that there is a basis for these Bo rds to no longer be a default pathway for approval as an Authorized User, an Authorized Medical P iysicist or a Radiation Safety Officer. Wc do not believe it v as the Commission's intent to minimize the importance of board certification or to imply those certified 1 the various specialty boards are not appropriately credentialed to utilize radioactive materials in the practit e of medicine. Upon review of the st, resolving this issue in the American College behalf of the followinj Sincerely, ft's recommendations, we are prepared to meet with you to discuss a pathway for an expeditious manner. Please contact Lynne Fairobent, Director Federal Programs of )f Radiology at if you have any questions concerning this request on boards. William R. Hendee, P1 President, ABR IZý4d. Robert E Ackerhalt, P President, ABSNM.D. dem4uiiiý id. James M. Galvin, DSc Executive Director, ABMP William HI. Blahd, M.D. Executive Director, ABNM Kathryn H. Pryor, MS, Chair, AB1IP CHIP cc: Commissioner Greta Joy Dicus Commission 1N Is J. Diaz Commissioner Edward McGaffigan, Jr. Commissioner Jeffrey S. Merrifield

Requirements Dear Chairman Meacbve. On behalf of the Ame ican Board of Radiology (ABR).

5 ; Nov :25PM; Paoe 4/5 Sent By: RESEARCH & TECH; ; Nov :25PM; Page 4/5 Chairman Richard ) Meserve Nuclear Regulatory Commission One White Flint No,th Building Rockville Pil Rockville, MD October 17, 2002 I Re: Staff paper related to 10 CFR Part 35 Training and Experience Requirements Dear Chairman Mesbrve: Please congratulate' he staff, especially Mr. Francis (Chip) Cameron and Ms. Linda M. Psyk, involved in the well conducted public workshops related to the implementation of 10 CFR Part 35. We recognize th ýt these workshops have involved a significant amount of staff work over a short time. Additionally we wo Id like to thank the Commission for supporting the attendance of U.S. Nuclear Regulatory 'ommission staff at meetings of medical specialties that will be affected by the implementation "f the rule. Open discussion is imperative to address the important issues that still remain in the c' "Tent form of the rule. In particular, Dr. Susan M. Frant's openness and willingness to addrel s the training and experience issue as it relates to specialty board recognition has been beneficial for our members. The diagnostic radiology, radiation oncology, nuclear medicine an( medical physics community is most appreciative of her efforts. To resolve the remai and experience publi This will alloy iing implementation issues, we urge you to make the staff paper on training Dly available as soon as the Commission receives it on or about October 18, review of the recommendations and prompt resolution of any remaining issues early in the Cc mmission's deliberations. Each facet of medica I radiology and physics continues its commitment to work with the Commission to resol ve the training and experience issue and move towards effective implementation of V( CFR Part 35. Among the radiological organizations committed to this effort are the: American College of Radiology American Association of Physicists in Medicine Society of Nuclear N [edicine American College of Nuclear Physicians American Society fo Therapeutic Radiology and Oncology

Mr. Francis (Chip) Cameron and Ms. Linda M. Psyk, involved in the well conducted public workshops related to the implementation of 10 CFR Part 35.

6 Sent By: RESEARCH & TECH; ; Nov :25PM; Page 5/5b Based on the long-! anding commitment to radiation safety, please know that these radiological organizations will c )ntinue to be fully committed to efforts that insure quality patient care, and which insure that ai thorized users represent physicians who are fully trained and board certified in the radiological :iences. Limiting access to radioactive materials to authorized users who are physicians trained rid board certified in the radiological sciences becomes critical when homeland security Please contact Lyni Radiology at following associatii e Fairobent, Director Federal Programs of the American College of' if you have any qucstions concerning this request behalf of the ns. Thank you for youritimc and consideration of these most important matters. Sincerely, E. Stephen Amis Jr M.D. Chairman, ACR BD ard of Chancellors Nora A. Janjani, M.D., F.A.C.P., F.A:C.R. Chairman of the Board, ASTRO Robert Gould, Ph.E President, AAPM D Michael J. Galfand, M.D. President Society of Nuclear Medicine Gary L. Dillehay,. President ACNP cc: Commissiol er Greta Joy Dicus Commissioi Nils J. Diaz Commissiol er Edward McGaffigan, Jr. Cornmissio, er Jeffrey S. Merrifield William Tn vers, Ph.D., EDO Susan M. F ant, Ph.D Francis X. (,ameron Linda M. PFyk

thorized users represent physicians who are fully trained and board certified in the radiological :iences.

Sara Brock Counsel for NRC Staff

Sara Brock Counsel for NRC Staff NUCLEAR UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-D001 May 16, 2002 OFFICE OF THE GENERAL COUNSEL Charles Administrative Bechhoefer, Judge Chairman Richard Administrative F. Cole