ML20035A351
| ML20035A351 | |
| Person / Time | |
|---|---|
| Issue date: | 01/26/1993 |
| From: | Grimsley D NRC OFFICE OF ADMINISTRATION (ADM) |
| To: | Sherman P NEORX CORP. |
| References | |
| FOIA-93-14 NACMUI, NUDOCS 9303250184 | |
| Download: ML20035A351 (2) | |
Text
-
U.S. NUCLEAR REGULATORY COMMISSION MC i Ol A hE QUt 51 AUWL NS)
^ @t L FOIA 14 h
. /.,,,a %
! r 'A ngDNst im
}-
RESPONSE TO FREEDOM OF xyl out I l-'
i
%....f !
T INFORMATION ACT (FOIA) REQUEST o^'t
./
JAN 2 61993 DOct!.1 NUYE E R4Si r!'assata.w/
RE QUE ST E R Pauline E. Sherman PART l.- AGENCY RECORDS RELE ASED OR NOT LOCATED ISee chededtroses!
No agency ret ords subject to the reauest have been located No additionat agency records sub;ect to t'ie request have been located Requested records are ava :abie ihrougn another punhc d.stribution prcya-See Cow.ments section.
Agency records sub;ect to the reavest that are. dent Aed in Appendu tem are a ready avanable for pubhc mspection and copying at the NRC Pubhc Document Room. 2120 L 5t eet N.W NsNngton. DC.
Agency records subject to the request that are identified in Annend x es A
a,e bemg made asailabie for putut inspect.on and copying t
X st the NRC Pubhc Document Room. 2120 L Street, N W., Washmrom DC. m a fo:cer under this F OI A number.
The nonpropretary temon of the propoest that vos agreed to a voi in a v phone conversation oth a rnember of rny staf' s now be-ng made availabfe for pubhc inspection and copy.ng at the N RC Pubhc Documem Roo r 2120 L St cet, N W, Washington. DC. in a foider unde this FOI A number.
Agency records subien to the request that are ideat:fied in Ap;.end n'es) may tu irtspected and cop.ed at the NR C Local Pubhc Documeng Pcom ident.fied m thi Commeris section.
E nc!used is m'ormtion on how g ou me y oats,n a;c"ss to and the chatrs fo' copy og records iocated at t% NRC Pubhc Document Room.2120 L St*eet, NW Wash ag or-DC.
y Arney records u;ect to the reauen are enciosed Records subrect to the recyst have been referred to another Federal brorvi+si for reneA and duett response to you.
F ees You oM be bd ed by the NRC for 'ees totahng S.
You mh re:ene a refund from t*w NRC en the amount of S In view of NRC's response to tNs recuep, no fu@e' act on is bem;; t.>6 er. csn ap;wa' !etter dated No PART II. A-INFORMATION WITHHELD FROM PUBLIC DISCLOSURE Cenam inf or net.or in the reavested reco-ds is being ^ ; hheld f rom put Oc d'sctcs.re psrsuant to the exemptions descrit.ed m and for the reasons stated in hrt II 6, C, and D Any reieased portions cf the (Muments for wNch o% pa't of the record is bEir*9 Mthheld 8'E being r"bde Psedatde for pubhc j mspection and cop, mg in the fsRC Pubot Document Room,2120 L Street, N W.Wan.ripton, DC m a f omer uncer tms FOI A ns m ber.
COMMENTS You are not being assessed processing fees since the minimal fee limit has not been exceeded.
I SF 9 URE. Di5iECTC R. Dn :Sr e LP F EL E DDh* 0F INF DRM AT ION AND PMUCAT !DNS 5E F t scl$
b TM
/'a t M L
/
l 9303250184 930126 l
SHERMAN93-14 PDR
, 7
Re:
FOIA-93-14 APPENDIX A DOCUMENTS BEING PLACED IN THE PDR HUMBER DATE DESCRIPTION 1.
11/05/92 Memorandum from Siegel to Cunningham, subject: Certification of the Minutes of the October 22 and 23, 1992 Meeting of the Advisory Committee on the Medical Uses of Isotopes (10 pages)
M k
+
p 9
e nco
- f UNITED STATES
!),;
%j' NUCLEAR REGULATORY COMMISSION
-??
E WASHINGTON, D. C. 20555
- W [j_ E ss, ~
MEMORANDUM FOR:
Richard E. Cunningham, Director Division of Industrial and Medical Nuclear Safety, HMSS FROM:
Barry A. Siegel, M.D., Chairman Advisory Committee on the Medical Uses of Isotopes
SUBJECT:
CERTIFICATION OF THE MINUTES OF THE OCTOBER 22 AND 23, 1992 MEETING OF THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES I hereby certify that to the best of my knowledge and belief, the enclosed minutes for the October 22 and 23, 1992, meeting are an accurate record of the proceedings for that meeting.
t W 6L /
MO Barry A. Siegel, M.D., Chairman itf S fCl>
(Date) i l
l g..... i *' ' ' '
'r.
i
9
/f ng%,
UNITED STATES
- j,;,
i NUCLEAR REGULATORY COMMISSION
- &,,i ",i WASHINGTON, D. C. 20555 ajj MEMORANDUM FOR:
Richard E. Cunningham, Director Division of Industrial and Medical Nuclear Safety, NMSS FROM:
Barry A. Siegel, M.D., Chairman Advisory Committee on the Medical Uses of Isotopes
SUBJECT:
SUMMARY
REPORT - MEETING 0F THE ADVISORY COMMITTEE ON THE MEDICAL USES OF IS0 TOPES, OCTOBER 22 AND 23, 1992 The Advisory Committee on the Medical Uses of Isotopes (ACMUI) held its semiannual meeting on October 22 and 23,1992, at NRC's One White Flint North Building in rooms 1-F-7 and 9.
Committee members present at the meeting were:
Barry Siegel, M.D., Chairman William Briner, Capt., USPHS (Retired)
Judith Brown Steve Collins Daniel Flynn, M.D.
Melvin Griem, M.D.
Carol Marcus, M.D., Ph.D.
Gerald M. Pobost, M.D.
Curt Scribner, M.D.
Also present: John E. Glenn, Ph.D, Nuclear Regulatory Commission (NRC),
(Designated Federal Official for the meeting), and Larry W. Camper, Section Leader, Medical and Academic Section, NRC.
Prepared presentations were made i
by Larry Camper, NRC; John Telford, NRC; and Donald Cool, NRC.
Dr. Siegel announced that Carol Marcus, M.D. would recuse herself as a member of the ACMUI from the discussions of the resolution of the ACNP/SNM Petition and the petitions regarding patient release criteria, but would be allowed to comment as a member of the general public, if time permitted.
The ACMUI discussed the issues and made the recommendations indicated below 1.
Committee Procedures:
In an August 25, 1992 Staff Requirements Memorandum (enclosed), the Commission i
directed several questions to the ACMUI that required responses.
1 47mzo24t 899
t a.
In response to the directive from the Commission to summarize each meeting and provide consensus and dissenting opinions in a timely fashion, the ACMUI committed to come to closure on each issue as it was discussed, and to record dissenting as well as consensus opinions.
This summary will be in the form of minutes prepared promptly after the meeting, rather than a letter drafted by the ACMUI during its working sessions. The draft minutes will be circulated to the members for comment and correction before they are finalized by the Committee J
Chairman.
r r
b.
In response to the question regarding the NRC resources allocated for j
ACMUI support, the ACMUI is unaware of any resource deficiencies at this time.
In response to the question regarding the size and representation of the c.
ACMUI, the Committee reviewed the current representation and agreed that there are no individuals or groups of individuals who they believe are 1
over-or under-represented on the committee.
The Committee was uncertain what impact the addition of three additional members next year would have on its conduct of business.
d.
In response to the question of the value of a national study of the impact of regulation by all agencies having a regulatory interest in nuclear medicine, the committee suggested that such a study should be funded by NRC because it would be of considerable scientific interest and 7
value if done well.
The ACMUI recommended that the study would best be l
conducted at a university or by a neutral professional group and that it should be independent of the national laboratories.
They did not suggest a specific professional group that was willing or able to conduct the i
study.
Dr. Siegel provided the names of several economists with expertise in this area who could advise NRC regarding the feasibility of such a study, the scope of a proposed study, and the parameters to be addressed in a request foi proposal.
Several members expressed concern i
that the term " nuclear mcdicine" was used, to the apparent exclusion of the field of radiation oncology, in which byproduct materials play such an important role in cancer management.
It was agreed by the Committee l
that the study should address all uses of byproduct material in medicine.
In response to the Commission's question of the desire for an annual meeting, the Committee responded that, although the meeting with the 1
Commission in July 1992 permitted a valuable exchange of ideas and concerns, the need for a full annual meeting will depend on the issues under consideration at the time.
In those years when there are no or few pressing issues, the Committee may elect to send a subcommittee to meet with the Commission, or include the ACMUI's annual report with the annual briefing by the NRC staff. All members agreed completely except for Mr.
Collins, who added that when a subcommittee presented issues, anyone with dissenting opinions should attend the Commission briefing.
a 2
9
?
k i
2.
Analysis of the Medical Issues Paper:
l Appendix A Medical Policy Statement l
The ACMUI agreed that item number one of the Policy Statement is an entirely appropriate focus of the NRC's regulation of medicine.
With regard to item number two of the Policy Statement:
the majority of ACMUI members believed this item was appropriate, but with modification as follows: "The NRC will regulate the radiation safety of patients where clearly justified by risk to patients and where voluntary standards, or compliance with these standards, are clearly inadequate." The Committee pointed out that, given an existing set of regulations, it is hard to document compliance with voluntary standards, thereby making deregulation apparently difficult to justify.
two members of the ACMUI believed that item number two of the Policy Statement is adequate as is.
two members believed the item should be discarded, since it is no longer valid.
With regard to item number three of the Policy Statement:
The majority of ACMUI members believed the phrase "will minimize intrusion" shculd read "will not intrude."
One ACMUI member dissented and said that the phrase "will minimize intrusion" should remain.
One member said the phrase "will not intrude unless absolutely necessary" should be substituted.
It was pointed out in discussion that the extreme circumstances that would justify intrusion into medical judgements would very likely equally relate to radiation safety of the general public or occupational workers, and would garner the support of most individuals in the medical community.
2 There was ct.3ensus that the Statements of Consideration accompanying rulemaking in the medical use program should include an analysis that addresses the consistency between the rulemaking and the Medical Policy Statement.
l 1
3 1
im -
=
Appendix B 10 CFR Part 35 According to the Committee, four general types of regulations included in Part 35 relate to:
1.
Training and experience of authorized users and RS0s 2.
Protection of medical workers 3.
Management of medical radiation safety programs 4.
Prescriptive regulations relating to patient, worker, or public radiation safety The Committee had no strong opinions that major components are missing from Part 35.
The Committee suggested that apparent regulatory gaps be covered as needed to minimize the necessity for exemption requests for emerging technologies. To the extent feasible, the ACMUI favors that rules, licensing, inspection, and enforcement be based on performance standards.
The Committee, in its discussion, pointed out several examples where overly prescriptive regulations were in need of modification.
The Committee recommended that ACMUI be involved as early as possible in potential rulemaking endeavors, and further recommended that the NRC should evaluate risk in the broader perspective of medicine as a whole.
Research and analysis should include thorough assessment of the impact on medical practices.
With regard to the impact of the record-keeping requirement associated with Quality Management programs, the ACMUI commented that it is too early to tell.
However, they cautioned that the expense may be in the annual audit.
They indicated that a benefit might be that licensees will look at their programs more carefully and find methods for improvement.
The ACMUI was able to provide only anecdotal evidence regarding the impact of misadministration reporting on malpractice litigation, but such evidence as is available suggests an adverse impact.
The Committee recommended that the-term -
" misadministration" had taken on a pejorative connotation that might actually be interfering with reporting.
The Committee suggested that a new term be considered by NRC.
Appendix C Inspection and Enforcement The Committee agreed that unannounced inspections achieve the purpose of reviewing routine radiation safety practices. However, they recommended that inspections should focus on personnel rather than on the " paper trail."
4
I i
4 Dissenting Opinions:
Dr. Flynn believes that inspections of brachytherapy programs should put more emphasis on the nursing staff who are responsible for the day-to-day care of these patients.
Dr. Marcus believes that inspections should not be unannounced, but should be conducted with a few days notice in order to ensure the availability of the authorized user physicians.
The Committee is in favor of non-cited violations (NCV's) for minor problems relating to the quality or safety aspects of a program. To the extent that inspections can be made less adversarial, inspections would be more effective.
With regard to penalties associated with enforcement actions, the Committee t
agreed that the dollar amount of most civil penalties was relatively small (relative to the total budgets of most medical licensees, especially i
institutional licensees), and thus not likely to constitute an effective deterrent.
Press releases were a more effective deterrent, but also are more likely to prevent compliance with reporting.
The Committee agreed that putting a facility on notice for potential loss of license for major programmatic problems would be the most effective deterrent.
l The Committee recommended that the NRC should explore substitution of voluntary accreditation by professional organizations for some of the NRC inspection processes.
Appendix D Medical Supervision Including Related Training and Experience Issues
[
The Committee agreed that training and experience requirements should be general and focus on basic radiation sciences and radiation safety. However, some practical and clinical experience, as it relates to application.of didactic principles of radiation safety, is necessary and must be documented.
The Committee recommended a testing process (which could be administered for NRC by a testing service) for physicians and RS0s to evaluate competence, in conjunction with a revised preceptoring process involving attestation by the preceptor that the trainee has learned the requisite material. The Committee also recommended that the NRC prepare or sponsor the preparation of a
" syllabus" of core radiation-safety and basic-science knowledge.
The Conmittee recommended against abrogating the primary responsibility for radiation safety to-a new class of non-physician " authorized users."
i The Committee.did not believe that the training and experience of an authorized user is necessarily sufficient to qualify him or her as an RSO.
However, the authorized-user physician can be an RSO for activities in which 5
i
I f
he or she is directly involved. Accordingly,_the training and experience for an RS0 needs to match the scope of the license more directly.
l The Committee recommended that it is appropriate for NRC to monitor the adequacy of the radiation safety component of consultant radiation safety I
courses, residency programs, and board certification courses.
However, if NRC adopts the universal testing process, this need only apply if certification programs are given deemed status.
The Committee recommends that 10 CFR 35.920 (training for imaging and l
localization) should be revised to more appropriately reflect the knowledge base required for safe practice. Additionally, revisions should allow NRC to extract itself from " turf battles."
The Committee recommends that 10 CFR 35.930 (training for therapeutic use of radiopharmaceuticals) should be revised to more appropriately reflect the knowledge base required for safe practice. This will be especially required as new therapies emerge.
The majority of ACMUI members recommended against requiring and specifying minimum training and experience for other personnel involved in the medical use of byproduct material until there is clear evidence that a problem exists.
Drs. Flynn and Griem dissented and believe that some level of training and experience should be required for nurses attending brachytherapy patients.
Judith Brown abstained.
The Committee recommended against creating a new class of " authorized supervisor" (non-physician) to be responsible for day-to-day safety issues associated with administration of byproduct material.
j There was a discussion of the problem of supervision by authorized users at remote facilities. The Committee consensus was that the small number of such applications should cortinue to be examined on a case-by-case basis.
Appendix E Communication The consensus of the committee is that the substantial majority of what is communicated by NRC is appropriately directed to the licensee. The Committee did recommend, however, that the NRC attempt to build an address list for its mailings to include not only licensee management, but also the RSO and the chief of service for each category of authorized use.
For important issues, the Committee also recommended using other vehicles such as the newsletters of the professional societies, to ensure communication with the individual users.
ACMUI agreed that NRC should conduct as many workshops as it can afford.
The Committee agreed that attendance and participation of NRC personnel in i
professional seminars and meetings is beneficial since talking to people in a neutral environment is intrinsically valuable.
6 g
,.n,m,,
All agreed that the Medical Visiting Fellows program has been an unequivocal l
success.
ACMUI recommends that NRC public notices, or at least notification of their l
existence, should be disseminated via other publications in addition to the l
Federal Reaister in order that members of the medical community as well as the general public may see them.
3.
ACNP/SNM Petition Resolution:
John Telford, of NRC, provided the staff's latest draft of a proposed rule (along with the existing rule for comparison) addressing the outstanding issues associated with the ACNP/SNM petition.
t Regarding proposed 35.6, the Committee discussed the implementation of the uniform Federal Policy for the Protection of Human Subjects, and the likely l
need to state these rules in their entirety in some other Part of 10 CFR. Mr.
Telford said that the Office of the General Counsel would resolve that issue.
l In a discussion of 35.50, 35.52, and 35.53 regarding the use of dose l
calibrators, Dr. Marcus was allowed to participate since the original petition j
did not address dose calibrators.
For 35.50(e)(3), the Committee suggested that the wording in the language be changed to reflect the identity of the i
individual performing the test rather than initials.
It was the recommendation of the Committee that 35.50 permit the licensees to rely on the activity measurements made by the centralized radiopharmacy for radiopharmaceutical dosages under those circumstances where the licensee's dose calibrator is non-functional for a short period of time. The Committee l
also recommended that dose calibrator linearity should be measured over the range from the highest activity administered down to 30 microcuries.
The reasons for the recommendation were (1) in some dose calibrators, a 10 i
microcuries lower limit (the current requirement) may largely represent i
electronic circuit noise within the instrument; (2) linearity over the range of administered dosages is the most clinically relevant and important component of dose calibrator linearity; and (3) the lower limit of thirty microcuries is consistent with the activity threshold addressed by the Quality-Management Rule.
l g
A discussion of 35.980 regarding training of authorized nuclear pharmacists (ANPs) and preceptor statements followed, and included possible mechanisms i
that might be used to add them to the license. At present these include.
1 1.
the licensee applies for an amendment 2.
the licensee notifies the NRC that the ANP is qualified by board certification; or 3.
the licensee notifies the NRC that the ANP meets the training and
[
experience requirements; It was the consensus of the committee that NRC should work toward a notification mechanism rather than a requirement for license amendment to add ANPs to licenses.
l 7
i
Overall, the ACMUI was strongly supportive of the final draft of the proposed rule. Dr. Siegel stated that this rulemaking activity served as an a
illustration of circumstances where the ACMUI functioned exactly as it should i
have. The Committee had the opportunity to discuss the policy issues early in l
the process and to provide constructive comments on successive drafts of the rul e.
l l
4.
Administration of Byeroduct Material to Preonant or Breastfeedino Women:
John Telford of NRC, provided a status report regarding future requirements for administration of byproduct material to pregnant or breast-feeding women.
i There was a discussion whether assessment of a women's pregnancy or nursing i
status should be required by rule language or more generally addressed in a Regulatory Guide. John Glenn of NRC reminded the Committee that,1f the need q
for assessment were only addressed in a Regulatory Guide, the development of 4
each licensee's program would require a license amendment. He believed this would impose an unnecessary burden un licensees.
l l
The Committee agreed that a performance-based rule would be preferable to a prescriptive rule. Ms. Brown expressed concerned that the final rule might be l
" watered down" by comparison with the principles discussed at the last meeting. Dr. Siegel indicated that there was no reason to be concerned that a performance-based approach would be less effective at achieving the objectives of the NRC.
Overall, the Committee agreed that the rule would likely do no harm and might do some good. Dr. Marcus dissented because she perceives no problem needing solution and no lack of voluntary acceptance of professional standards; accordingly, she believes that no rulemking is appropriate.
5.
Abnormal Occurrence Criteria:
Larry Camper of HRC provided an update of the staff's work in revising the criteria for the reporting of medical events as abnormal occurrences. He stated that the staff favored criteria focusing upon death of the patient, significant organ impairment, and mistakes involving multiple patients.
The staff will be preparing a Federal Reaister notice regarding this issue. The ACMUI will receive additional information at'its next meeting or in an interim package.
j 6.
Patient Release Criteria:
Donald Cool, Ph.D. of NRC provided a status report on the proposed resolution of the two petitions regarding patient release criteria that were received t
from Dr. Marcus and the American College of Nuclear Medicine. After 0
J l
r--a.-
i 4
{
considerable discussion, the Committee recommended that the 30-millicurie limit for release of patients from confinement be retained as an alternative to the dose-rate criterion (5 mrem /hr at I meter), with release in either case subject to fulfilling the criterion that the dose to any member of the general public may not exceed 500 mrem.
This will enable physicians to plan patient's hospital stays in advance.
The NRC should develop release criteria for patients who have been administered radionuclides that are not excreted to any significant extent, since release of patients with retained activities larger than 30 millicuries, or with dose rates exceeding 5 mrem /hr, may be justified for certain short-lived radionuclides.
Meetino Summary:
Dr. Siegel stated that he would prepare a draft summary of the meeting with NRC staff assistance.
The summary will be sent to all of the members attending the meeting for comments. Dr. Marcus was instructed not to comment on the sections pertaining to the two petitions with which she is involved.
Next Meetino:
The Committee members agreed that they prefer to meet in the Rockville/Bethesda area, both for their own convenience and for the i
convenience of the Commissioners and NRC staff.
It is hoped that NRC staff will re-explore the availability of meeting rooms at a Rockville/Bethesda hotel, but under any circumstances, ACMUI would prefer to meet again in 1-F-7 and 9 than to meet in Resten.
P W L <fA4p1A &
Barry A. Siegel, M.D., Chairman Mf Sf 0)2.
Date
Enclosures:
As stated t
9
. - -