ML20138G532
| ML20138G532 | |
| Person / Time | |
|---|---|
| Issue date: | 12/18/1996 |
| From: | Cool D NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Lohaus P NRC OFFICE OF STATE PROGRAMS (OSP) |
| Shared Package | |
| ML20138G538 | List: |
| References | |
| NUDOCS 9612190430 | |
| Download: ML20138G532 (2) | |
Text
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UNITED STATES g
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NUCLEAR REGULATORY COMMISSION b
WASHINGTON, D.C. 20066-0001 g,*****,/
cenber 18, 1996 T Jo i
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MEMORANDUM TO:
Paul H. Lobaus, Deputy Dire'ctor dD Office of State Programs 4
FROM:
Donald A. Cool, Director Division of Industrial and Medical Nuclear Safety
SUBJECT:
ComENT ON " RATIONALE OF PART G FOR THE FEBRUARY 29, 1996 REVISIONS TO THE SUGGESTED STATE REGULATIONS FOR THE CONTROL OF RADIATION
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As requested, we have reviewed the Office of State Programs' letter and comments to Mr. Terry Frazee, Chairman of the SR-6 Committee, regarding the
" Rationale for Part G," and have identified the following item:
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In "Section G.17 - Possession, Use, Calibration, and Check of Dose Calibrators," discussion of precision for source calibration requirements, NRC comments:
"The rationale should identify that both of the above NRC requirements need to be met for compatibility reasons." Review of the Statements of Consideration associated with Part 35 reveals that requirements in 10 CFR 35.50(b)(2), " Possession, use, calibration, and check of dose calibrators," are not items of compatibility for Agreement States. Therefore, we recommend that the last sentence in the paragraph entitled "NRC Comment" be i
deleted.
With the exception of the above item, we concur with the package, as provided.
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i EXECUTIVE TASK MANAGEMENT SYSTEM
<<< PRINT SCREEN UPDATE FORM >>>
TASK # - 6S-67 DATE- 07/18/96 MAIL CTRL.__....____
- 1996 TASK STARTED - 03/19/96 TASK DUE - 09/06/96 TASK COMPLETED -
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TASK DESCRIPTION - REVISED PARTS A, B, D,
F, G AND J OF THE SSRCRs REQUESTING OFF. - CRCPD REQUESTER - C.
HARDIN WITS -
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STAFF LEAD - KXS PROG. AREA -
PROJECT STATUS -
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REVIEW FINAL PART G AGAINST PART 35 AND TRANSMIT l
PLANNED ACC.
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December 29, 1995 Mr. Charles M. Hardin Executive Secretary Conference of Radiation Control Program Directors, Inc.
205 capitol Avenue Frankfort, KY 40601
Dear Mr. Hardin:
In our June 1, 1995 letter, we informed you that we could not concur on Part G of the Suggested State Regulations for Control of Radiation (SSR). We stated that we planned to explore with the Comission the issue of compatibility relating to State regulations in this area and would provide you with further information at a later time. The staff provided recommendations to the Comission in SECY-95-258 entitled " Compatibility Findings for Agreement States That Have Not Adopted a 10 CFR Part 35 Compatible Medical Quality Management Regulation" (Enclosure 1).
The Comission subsequently approved the recommendations by Staff Requirements Memorandum dated November 15, 1995 (Enclosure 2).
In sumr.ry, the Comission has approved the staff's recommendation to defer findings of compatibility, for a period of one year, for Agreement States that have not yet adopted a compatible Quality Management Program and O
Misadministration rule (QM rule).
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increased flexibility to Agreement States in two areas:The Commission also approvei (V
the timing of Quality.
Management Plan (QMP) submittals by licensees to Agreement State regulatory.
agencies, and the ability to expand Agreement State misadministration definitions to include reference to other non-Atomic Energy Act (AEA) modalities.
The conclusion of HRC's review of this matter has been connunicated to the Agreement States (see December 6, 1995, letter to all Agreement States, ). We encourage the Conference of Radiation Control Program Directors, Inc. (CRCPD) to follow guidance in that letter when completing revisions to Part G.
In addition, we are enclosing further NRC staff comments in three areas:
(I) Revisions needed to F' art G to achieve compatibility with NRC's QM rule (Enclosure 4); (II) Earlier NRC coments submitted to SR 6 via a letter dated September 22, 1994, that were not addressed in Part G submitted for concurrence, which we ask that you reconsider (Enclosure 5); and (III) Revisions needed to Part G related to incorporation of the radiophamacy rule into Part G to achieve compatibility with HRC's radiophamacy rule (Enclosure 6).
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Charles N. Hardin E 2 91995 For your convenience, below is a sumary of coments.in these three areas, I.
OM Rule: Revisions to Part G, as set out in Enclosure 4.~are needed to
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address submittal of QM plans and subsequent modifications to meet current compatibility procedures for the QM rule.
71.
Earlier NRC Coments-not Addressed in Part G: Some NRC coments on Part G, offered in a letter to Mr. Terry Frazee, dated September 22, 1994, were not adopted in the copy of Part G submitted for concurrence.
In addition, new NRC coments are offered on a subsequent modification to Part G regarding physician training and experience, Enclosure 5.
III.
Radiocharmacy Rule: The copy of Part G submitted for concurrence contained revisions to reflect some provisions of the radiopharmacy rule but did not address all provisions needed for compatibility. Revisions identified in Enclosure 6 are needed to Part G to achieve compatibility with NRC's radiopharmacy rule.
We appreciate the efforts of the CRCPD and the Part G (SR-6)'Comittee members
^
l in preparing an SSR rule, which will assist and facilitate State adoption of l
the QM and radiopharmacy rules.
l If you'hve any questions, or require further information, please' contact me i
or Lloyo Bolling at (310) 415-3340 or (301) 415-2327, respectively.
Sincer y
dM, @ed By RICHARD L BANGART p
Richard L. Bangarte Director g
Office of State Programs l
Enclosures:
l 1.
SECY 95-258 " Compatibility findings for Agreement States That Have Not l
Adopted a 10 CFR Part 35 Compat'ible l
Medical Quality Management Regulation" 2.
November 15, 1995 Staff Requirements Memorandum 3.
December 6,,1995 letter to All Agreement States 4.
Revisions needed to Part G for Compatibility 5.
Earlier NRC Coments not addressed in Part G 6.
Incorporating Radiopharmacy Rule into Part G Distribction:
DIR RF LCamper RBangart JSchluster PLohaus CPaperiello J. ;.., ~
BMorris FCameron CRCPD file DCD SP01 PDR YES_X_ NO DOCUMENT NAME:
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t nMSS:o iE NAME LBolling PLohaus VFCameron CPaperiello DATE 12/26/95* _ - -- - /26/9J*, _17M4 / 9 5 12 /13/95*
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DATED:
DECEMBER 6, 1995 SIGNED BY: RICHARD L. BANGART ALL AGREEMENT STATES MASSACHUSETTS, OHIO, OKLAHOMA, PENNSYLVANIA TRANSMITTAL OF STATE AGREEMENTS PROGRAM INFORMATION (SP-95-184)
Your attention is invited to the attached correspondence which contains:
INCIDENT AND EVENT INFORMATION.......
PROGRAM MANAGEMENT INFORMATION.......XX QM Rule Compatibility TRAINING COURSE INFORMATION..........
TECHNICAL INFORMATION................
l OTHER INFORMATION....................
Supplementary information:
As I believe most of you are aware, NRC staff has been reevaluating the issue of compatibility regarding Agreement State adoption of the medical quality management program and misadministration rule (QM rule).
Information regarding this evaluation has caused some uncertainty regarding the need for l
Agreement States to adopt a compatible QM rule at this time. As a result, some Agreement States have temporarily suspended their efforts to adopt a QM rule pending resolution of this issue by staff.
Because of this uncertainty, for any Agreement State that has not yet adopted a compatible QM rule, staff plans to defer compatibility findings on the QM rule for one year from the date of this letter.
If you have either suspended rulemaking in this area, or not yet initiated action to adopt a compatible QM rule, we encourage you to initiate or resume such rulemaking action. While we recognize current uncertainties regarding NRC's Mng-term role in this regulatory area, we also recognize the safety benefits. attendant with the QM rule. To help reduce unnecessary impacts involved in adopting this rule, we will provide flexibility to Agreement States under current compatibility policy regarding the submittal and review of quality management programs (QMPs), as well as accommodate the Agreement
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States desire to expand their misadministration definitions to include non-Atomic Energy Act (AEA) materials and machine-produced radiation. As a result, the following guidance applies:
ENCLOSURE 3
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O i V 1.
Agreement States have flexibility in determining the method by which a licensee is required to submit its QMP to the agency, and the timing of that submittal. An Agreement State should require that licensees develop and implement a QMP, certify that a QMP has been implemented, generally require QMP submittal, and conduct a review of the QMP.
However, an Agreement State has flexibility to choose whe.n and how it l
will receive and review the plan. For example, the plan could be l
submitted and reviewed during an inspection, or it could be submitted i
and reviewed through the State's routine licensing program (e.g., at the next major amendment or renewal).
2.
Agreement States also have flexibility to expand their misadministration definitions to permit coverage of other non-AEA medical radiation procedures or treatment modalities as long as the minimum definitions l
set out in NRC's regulations are adopted.
Such expansion could also include requiring more restrictive reporting requirements, such as those covering diagnostic misadministrations, not required by NRC.
In this case, however, the Agreement State must be able to separately identify those misadministrations for which reporting would be required us6g de
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NRC QM rule definitions.
Enclosed for your information is a copy of Commission Paper SECY-95-258 i
entitled, " Compatibility Findings For Agreement States That Have Not Adopted A
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10 CFR Part 35 Compatible Medical Quality Management Regulation" and the accompanying Staff Requirements Memorandum.
If you have any questions regarding this correspondence, please contact me or the individual named below.
POINT OF CONTACT:
Lloyd Bolling TELEPHONE:
(301) 415-2327 FAX:
(301) 415-3502 4
INTERNET:
LAB @NRC. GOV l
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Richard L. Bangart, Director Office of State Programs l
Enclosures:
4 As stated 2
1 i
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- 1. Revisions needed to Part G for Comoatibility with the NRC's OM Rule:
Five additions are needed to SSR Part G, as described below.
1.
Revi'sions to definitions for " authorized user" and " medical use".
2.
To cover existing licensees, add a new section to Part G substantially equivalent to Section 35.32 (f) (2) that would:
a) require a licensee to submit a written certification that the QMP has been implemented; and b) require a licensee to make the QMP available for review when requested by the regulatory agency.*
3.
To cover existing licensees, add a new section to Part G substantially equivalent to Section 35.32(e) that would:
a) allow licensees to make modifications to their QMP to increase the j
program's efficiency provided the program's effectiveness is not decreased; and b) require licensees to make the QMP modification available for review when requested by the regulatory agency.*
4.
To cover new applicants, add a new section equivalent to Section 35.32 (f) (1), requiring that the applicant include a copy of their QMP as a part of their application for a license.
5.
Modify Section G.13 such that the first sentence reads: "Each aoolicant or licensee......" (See Section 35.32 (a)).
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- In a November 7, 1994 letter from Terry Frazee, concern was expressed relating to the potential for a significant increase in workload for Agreement i
l State regulatory agencies that would occur with submittal of QM plans by a single certain identified date.
As indicated in All Agreement States letter SP-95-184, Agreement States have flexibility in determining the method by which a licensee is required to submit its QMP to the agency, and the timing of that submittal.
An Agreement State should require that licensees develop and implement a QMP, certify that a QMP has been implemented, generally require QMP submittal, and conduct a review of the QMP. However, an Agreement State has flexibility to choose when and how it will receive and review the plan.
For example, the plan could be submitted and reviewed during an inspection, or it could be submitted and reviewed through the State's routine licensing program (e.g., at the next major amendment or renewal).
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II.-Earlier NRC Comments not Addressed in Part G The following specific comments are divided into two areas. One relates
. to comments previously identified in the september 22, 1994, letter that vers not addressed in Part G.
The second area relates to 5 additional comments which relate to physician authorized user training and experience criteria.
Although comments in this second area are not required for compatibility, we ask that you consider addressing these comments in the final Part G rule.
1.
addition of " clinical procedure to be performed" to the syringe label; 2.
revision of the required upper end range for a survey instrument from 50 mrem to 100 mrem; l
3.
deletion of the concept of the visiting authorized user; and
-4.-
revision to G.68 and G.69 to clarify that applicants must complete a residency training program approved by the Accreditation Council for Graduate Medical Education (ACGME) that has a nuclear medicine component of six-months duration.
Currently, like 10 CFR 35.920, G.68 and G.69 incorrectly specify a six-month nuclear medicine training program approved'by ACGME.,dg Ns couvr i
The following comments are based on a review of final Part G relating l
to training and experience criteria for physician authorized users.
1.
Training for Therapeutic Use of Radiopharmaceuticals (G.69).. As written, this section imposes a substantial experience burden by requiring-that physician applicants obtain clinical experience with four radiopharmaceuticals (iodine-131, phosphorus-32, strontium-89, and gold-198).
The rationale for requiring the applicant to gain experience with all four radionuclides is not provided and may be difficult or impossible for some applicants to meet since Au-198 is not commonly used for radiopharmaceutical therapy.
2.
Section G.
69 deletes certain board certification titles offered l
by the American Board of Radiology (ABR),that were previously recognized in this section and retains only the certification title of " Radiation Oncology."
10 CFR-35.930 has retained all previously identified ABR certification titles so as to not inadvertently eliminate certain qualified applicants, e.g.,
ABR replaced the certification therapeutic radiology with radiation oncology within the last few years therefore both titles should be recognized in the language since according to ABR, I
the certification criteria remain unchanged despite the title I
change.
This comment alse applies to G.70.
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ENCLOSURE 5
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Limit of ABR Certification to diplomates after 1984.
The radiopharmacy rule revised 10 CFR 35.930 to limit authorization of physician users, certified by the American Osteopathic Board of l
Rddiology (AOBR) in Radiation Oncology, to physicians who were l
certified after 1984.
This revision was made based on information submitted by AOBR, during 1994, which indicates that AOBR did not address this medical specialty in its certification examination until after 1984.
Therefore, NRC does not recognize individuals certified under this title prior to, and including physicians certified in, 1984, for authorization for radiopharmaceuticals for therapeutic use.
NRC staff discussed this issue with the NRC's Advisory Committee on the Medical Uses of Isotopes in routine committee meetings held in May and November 1994.
4.
Two certification titles contained in G.69 are not contained in 10 CFR 35.930:
" Nuclear Medicine by the American Osteopathic Board of Nuclear Medicine," and " Nuclear Medicine by the Canadian Board of Nuclear Medicine."
One certification title issued by the Canadian Royal College of Physicians and Surgeons is different:
SSR " Therapeutic Radiology by the Canadian...." and NRC " Nuclear Medicine by the Canadian....."
5.
Training for Ophthalmic Use of Strontium-90 (G.71).
10 CFR 35.941 does not recognize board certification as a criteria for authorization of physician users; rather didactic and supervised clinical trainir.g criteria are described.
G.71 recognizes ABR certification as an alternative but does not recognize other board certifications that may provide equally qualified applicants, s
e.g.,
AOBR.
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ENCLOSURE 5
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.III. Incorooratina NRC's Radiocharmacy Rule into Part G:
na NRC staff understood, based on the Maine meeting, that the SR-6 committee did not intend to address the radiopharmacy rule at this time, except fo.r two necessary definitions dealing with a teletherapy misadministration and recordable event that are needed in Part G for clarity.
While revieving Part G, staff noted, however, that certain provisions in the radiopharmacy rule were adopted while others were not.
For example, Part G was revised SJ delete the requirement that licensees follow package inserts for preparation and indications of use, concistent with.the radiopharmacy rule, but the concepts of the i
authorized nuclear pharmacist and medical research involving human subjects were hot adopted.
We support the inclusion of the radiopharmacy rule into Part G.
The following are staff comments on revisions needed to Part G to achieve compatibility with NRC's radiopharmacy rule.
l 1.
Section G.25, " Suppliers," requires that licensees "shall use for medical use radiopharmaceuticals' compounded from a prescription in accordance with the regulations of the State Boards of Pharmacy.
This language may impose a significant restriction on future
" authorized nuclear pharmacists" in Agreement States, in that, it requires them to compound from a prescription rather than allowing the flexibility for drug preparation as provided by the radiopharmacy rule.
During promulgation of the radiopharmacy rule, staff learned through discussions with representatives of the nuclear pharmacy community, that this type of restriction is inconsistent with the current practice of pharmacy.
This is a compatibility division level II item.
2.
Sections G.31, G.33, and G.37 (comparable to 10 CFR 35.100, 35.200 and 35.300) require licensees to use a radiopharmaceutical "which is prepared and compounded in accordance with the regulations of th9 State Board of pharmacy."
While linking the preparation of radiopharmaceuticals to the regulations of the State Boards of Pharmacy is credible, some Agreement States licensees may be unable to comply, in that, it is our understanding that State pharmacy regulations vary among the j
States, and in fact, some State regula %'ons do not address the practice of radiopharmacy.
We recommend that wording compatible
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with 10 CFR 35.100, 35.200 and 355300-b'e u=ed.
i Nj Section G.19 dealing with the assay of alpha ~ and beta ~ emitting 3.
radionuclides.
The new requirement described in 10 CFR 35.52(b) requires NRC licensees to measure, by direct measurement or by combination of measurements and calculations, the amount of radioactivity in dosages of alpha-or beta-emitting radionuclides.
G.19 only allows the " assay" of such dosages.
The term " assay" typically refers to direct measurement, and there are inherent technical difficulties with attempting to directly measure the activity of a beta-emitting radionuclide with the typical
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ENCLOSURE 6 s_
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1 og ionization chamber dose calibrator.
Therefore, NRC allows its licensees flexibility to employ other reliable measurement techniques such as volumetric determinations, liquid scintillation counting of an aliquot, or the use of a device specifically designed to measure beta radiation in patient dosages.
Although this is a compatibility division level II item, where the states d.
may be more restrictive, we believe that use of the term " assay"
- - is overly restrictive.and limits the licensees' use of alternatives.
4.-
Section G.29.
The dosage assay record keeping requirements described in G.19 do not appear to be compatible (Division Level II) since the following required items, described in 10 CFR 35.53(c), are not included:
the generic name, trade name or abbreviation, its lot number, and expiration date of the radiopharmaceutical.
Additionally, although G.19 requires licensees to measure the activity of each radiopharmaceutical that contains more than 370 kilobecquerels (10 microcuries) of a photon-emitting radionuclide, it does not require licensees to measure the radiopharmaceutical to confirm that its activity is less than or equal to 10 microcuries or make a notation that the activity is less than or equal to 10 microcuries (consistent with previous 10 CFR 35.53).
The radiopharmacy rule revised this measurement threshold from 10 microcuries to 1.1 megabecquerels (30 microcuries).
This is a compatibility division level II item.
5.
G.2, " Definitions," does not include the definition of " medical
- 9gy, CFR 30.4use," as revised by the radiopharmacy rule, and described in 10 and 35.2.
This is a compatibility division level I item.
6.
G.21, " Requirements for Possession'of Sealed Sources and Brachytherapy. Sources."
Although the radiopharmacy rule revised the signature requirements for the dose calibrator quality control test records to allow the individual who performed the test to sign the record, the rule did not revise the signature requirements for leak tests and radiation survey records.
NRC regulations still require that the Radiation Safety Officer (RS0) sign the leak tests and radiation survey records.
However, in Part G, the. signature requirement was revised for all three records to allow the individual who performed the test or survey to sign the record.
This change in signature requirements could be' interpreted as less restrictive than NRC requirements since the RSO is not required to sign, and may not review the results of the tests or surveys.
As a result, the licensee may not identify potential radiation safety issues in a. timely manner.
This is a compatibility division level II item.
ENCLOSURE 6 9
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