ML20203L171
| ML20203L171 | |
| Person / Time | |
|---|---|
| Issue date: | 01/30/1998 |
| From: | Thoma J NRC |
| To: | Dexter T NRC |
| Shared Package | |
| ML20203L122 | List: |
| References | |
| FRN-62FR63634, RULE-PR-30, RULE-PR-32 NUDOCS 9803050384 | |
| Download: ML20203L171 (1) | |
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h From John Thoma To TWD2.TWP3.DAC, TWD2.TWP8.FCC, TWD2.TWP84CXH
- Dates.
1/30/98.4:39pm' Subjects CAROL MARCUS LETTER
'Hugh Thompson just read Carol Marcus' letter of January 15, 1998 concerning microcurie capsules of C-14.
He said to respond by saying something to the effect.of " consistent with our letter of
, the NRC will not respond to the. issues in your letter of January 15,'1998 because (describe the inflamatory language clause in our. letter) " -- and send a cc to her boss. This is not an exact quote to be used in the letter -- so use whats.ver the appropriate words are.
But
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. basically do=not respond to the details of her letter.. If you have any questions, call me at 415-1724.
- Thanks,
- John Thoma CC:
TWD2.TWP8.CJP1, TWD2.TWP8.WFK
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NUCLEAR REGULATORY COMMISSION UNITED STATES
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WASHINGTON, D.C. 20555-0001 March 14, 1997 CHAIRMAN.
Carol S. Marcus, Ph.D., M.D.
Director, Nuclear Medicine Outpatient Clinic Harbor-UCLA Medical Center Professor of Radiological Sciences, UCLA 1000 Carson Street
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' ' Torrance, California -90509
Dear Dr. Marcus:
I am responding to your letters dated January 24, 1997 and February 4, 1997, concerning possible modifications to 10 CFR Part 33 for broad scope licensees, and what you allege to be serious errors in the accuracy of certain NRC
-documents regarding recommendations by the Institute of Medicine of the National' Academy of Science (NAS/IOM) in its recent report entitled, fladiation in Medicine - A Need for Reaulatory Reform.
Let me assure you that there is no validity to your charge that the Commission has propagated false information about the NAS report and its recommendations to affected agencies
-and crganizations.
Our goal is to ensure thtt such reports are publicly-available so that :aterested and affected parties may draw their own conclusions and provide such input to NRC.
Let me clso assure you that individual Commissioners and responsible NRC management and staff have read and do understand fully the NAS report and its recommendations, including the dissenting views of Mr. Robert Adler, the sole member with regulatory experience. The Commission has been briefed by the NAS, the Advisory Committee on the Medical Uses of Isotopes (ACMUI) and the staff on the report in te public meetings. The staff also has solicited the opinion ~ of other Federal aancies, State agencies, medical professional organizations, and other interested and affected parties on the NAS report.
As yoin know, the NAS report also has been considered within the context of NRC's Strategic Assessment and-Rebaselini19 Initiative (SA), Direction Setting Iss'ue No. 7, " Materials / Medical Oversight," Based.in part on the comments received on DSI-7, the preponderance _of which supported the Commission's preliminary views, and despite~your strong but generally unsupported arguments to the contrary, the taission continues' to believe that the conclusions in
.the repo t were not substantiated and that the recommendations should not be pursued.- The Commission's virws have only been bolstered as a-result of the public comments received during SA.
(Enclosed _is the summary anOysis of- _
comments from the. Phase II Stakeholder Interaction Report, which you may find u f-interest).. In view of this, the Commission will not allow the discussions o
at_ upcoming public workshops on-the major-revision of Part 35 to be dominated
_by discussion'of;the.NAS report and-its recommendations.
We trust that medical professional organizations, the ACMUI and others will take advantage of suchNportunities to provide meaningful input to, and work with, the NRC staff to 1elp formulate an improved medical use regulatory program.
-You~ stated that the National-ACNP continues to support the NAS
. recommendations.. This statement is in conflict 'with the statement of thc President of the ACNP during the SA meeting conducted last~ fall in Washington, a
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D.C.
He stated that ACNP has modified their previous support for the NAS recommendations and now supports the Commission's preliminary views to continue the ongoing program with improvements and decrease oversight of low-risk activities with continued emphasis in high-risk activities. He did not qualify that ACNP position as one adopted for " damage control" purposes.
Your statement that the NAS recommended that all medical aspects of the regulatory, program "be returned to the only group intellectually capable of handling them, the Medical Board of each state" is incorrect.
Instead, the NAS recognized that most State radiation control programs have a regulatory framework that could accommodate increased authority for the medical use of byproduct material and tNu the NAS/IOM recommended that States take on a greater regulatory role. Many States and the Organization of Agreement States indicated a need for Federal oversight and some States identified NRC as the preferred agency.
The Conference of Radiation Control Program Directors (CRCPD), who the NAS expresses confidence in, commented to NRC that the
'aosence of Federal authority in medical use may have immediate and undesirable consequences.
Further, the CRCPD did not support the automatic selection of the Department v Health and Human Services (HHS) as the lead Federal agency, as recommended i. the NAS report.
Nor has HHS sought that role.
You also raised the issue regarding regulatory educational requirements for authorized physician uscrs and emphasized that the issue of medical competence is within the jurisdiction of State Boards of Medicine. We fully agree and statements from which it is inferred that NRC evaluates the medical competency of its applicants are being misinterpreted or misread.
Rather, NRC's training and experience criteria for physician users are intended to ensure that physicians who seek authorization for medical use have an acceptable level of radiation safety training to ensure the safe handling of byproduct material.
To this end, several training pathways are recognized in NRC's medical use regulations, including certification by professional boards such as the American Boarc' of Nuclear Medicine.
Regarding naturally-occurring and accelerator-produced radioactive materials (NORM /NARM), comments received during SA indicate a desire by some for NRC jurisdiction over NORM and NARM.
Such an approach would be risk-based and would provide for a consistent and uniform medical use program nationwide.
The Commission would not necessarily discourage such an approach and may even invite such change if an enhanced level of public health and safety would ensue.
In fact, NRC is evaluating these issues with respect to-its entire materials program.
With regard to the Quality Management Program provisions of 10 CFR'Part 35, the Commission has directed the staff to reevaluate the rule, aided by comments from experts in the medical field, to identify those elements which in the ager.cy's best judgment, cre critical to ensure patient and public safety from the use of byproduct materials utilizing a risk-informed, performance-focused approach. Tnis approach will be applied to Part 35 in its entirety as NRC begins the major revision of Part 35 later this year.
As a result, it is likely that modifications to the rule will lessen the perceived burden to NRC licensees. As stated previously, we invite affected and interested-parties to participate in this rulemaking process through various t
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opportunities that NRC will provide to solicit input.
However, let me also assure you _that on the issue of whether NRC should or should not retain.
jurisdiction over certain types of byproduct material uses, the Commission will not be persuaded by unsupported arguments, invective and ad hominem remarks. On the contrary, NRC will continue in its efforts to fulfill its statutory obligation and responsibility for the medical use of byprcduct material.
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With ' regard to the run Meanced Notice of Proposed Rulemaking for 10 CFR Part 33, the staff prog m to consolidate and codify its licensing baser used to license-broad scope progratas for medical use as found in existing NRC guidance documents. The rulemaking process will provide another opportunity
.for affected and interested parties to comment on the requirements being consioered for inclusion in the rule. Like the efforts on 10 CFR Part 35, the
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staff will apply a risk-informed and more performance-focused approach to
. revisions of 10 CFR Part 33 and related guidance. The specific comments you
-raised-in your January 24, 1997 letter will be considered by the staff as it
-develops a proposed rule for public comment.
r As to_ your comment on the Office of Management and Budget (0MB) clcarance, the NRC received clearance on the information collection requirements for the recently promulgated patient _ release rule on January 6,1997. The staff believes that it has addressed the conceras raised by OMB and intends to submit the revised regulatory guide to OMB, as requested.
I continue to find the tone of your letters highly unprofessional and your attacks on the integrity of the NRC staff and Commission itself unacceptable, l.'e recognize that officials of Federal, State and local government are public servants and as a result have a certain obligatisa to respond to commer.ts and L
_ inquiries from members of the public. ' However, this desirable cnmmunications
-procass should not allow or tolerate continued abuse of such officials.
Such tactics generally result in skepticism over the issues you raise and have, in the long run, an effect which 1 assume you would find contrary to your goals.
If, on -the 'other hand, you have serious concerns regarding specific activities of specific NRC employees or Commissioners, or believe that particular employees or Commissioners hava engaged -in wrongdoing, I encourage-you to-L report such concerns to the NRC's Office of Inspector General.
In addition, the time and NRC resources expended to respond to your letters have in r y
= cases been excessive.- In the future, while we will continue to conside' the
- issues you raise, you should not expect-to receite a response to any ietter containing abusive personal attacks on the Commission or the NRC staff.
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~Likewis we see no need to expend resources on letters that.merely repeat points raised by you and answered by NRC in the past.
Sincerely, b
Shirley Ann-Jackson -
Erciosure: 'As s'tated
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