ML20203M019
| ML20203M019 | |
| Person / Time | |
|---|---|
| Issue date: | 01/30/1998 |
| From: | Callan L NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | |
| References | |
| SECY-98-016, SECY-98-016-01, SECY-98-016-R, SECY-98-16, SECY-98-16-1, SECY-98-16-R, NUDOCS 9803060356 | |
| Download: ML20203M019 (65) | |
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RULEMAKING ISSUE (Notation Vote)
Januarv 30.1998 SECY-98-010 EQB:
The Commissioners FROM-L. Joseph Callan Executive Director for Operations
SUBJECT:
SPECIFIC DOMESTIC LICENSES OF BROAD SCOPE FOR BYPRODUCT MATERIAL PURPOSE:
To obtain Commission approval to terminate proposed rulemaking revising 10 CFR Part 33,
' Specific Domestic Licenses of Broad Scope for Byproduct Material," and to proceed with finalizing draft guidance in a NUREG.
BACKGROUND:
The staff submitted a Commission Paper, SECY 96167, dated July 30,1996, requesting approval of an Advance Notice of Proposed Rulemaking (ANPR) for Part 33, " Specific Domestic Licenses of Broad Scope for Byproduct Material." The Commission approved the ANPR, in a Staff Requirements Memorandum (SRM) dated September 18,1996 (Attachment 1). The Commission directed the staff to add a detailed definition of the term
- broad scope," to include a question regarding the separation of contamination elsk versus extemal radiation risk, and to include a discussion, and request for comments, on the balance between performance based and a prescriptive approach for regulating broad scope licensees. Ti.a Commission also recommended that the staff address the issue of whether non-Fen at licenser,,1ay obtain master materials licenses (MMLs). Additionally, the Commission ludicate ' thM ',e staff
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should consider finalizing any guidance on broad scope licensees' radiation safety officer training and experience conte!ned in draft guides. These issues were addressed in the ANPR.
QlscussION The ANPR was noticed in the Federal Register on November 14,1996 (61 FR 58346). The comment period closed February 12,1997. The staff received 22 comments on the ANPR (there are 371 broad scope licensees,145 of which are academic facilities or medical institutions). An analysis of the comments is included in Attachment 2. Generally, the commenters did not see a valid reason to amend the regulation for broad scope licensees, and indicated that the proposals discussed in the ANFR were overly prescriptive. One commenter agreed with the background section of the ANPR which stated that, "The current program governing the regulation of specific licenses of broad scope for byproduct material has worked well to provide for public health and safety from these licensed activities.' This commenter went on to say that the Nuclear Regulatory Commission should examine the 38 specific incidents during 19931996 and evaluate their significance in terms of risks to employees and the public. The commenter did not believe that the smallincrementalincrease in risk that these incidents posed justified overhauling the broad scope regulatory framework which has proven effective for many years. Many commenters indicated that the specific responsibilities of licensee management should not be included in the Federal regulations; that the role of management varies for different types of programs. Additionally, many commenters stated that the overall objectives of the radiation safety officer (RSO) and the radiation safety committee l
i (RSC) should be provided in Part 33, while exsmples of qualifications, duties, and responsibilities should be discussed in regulatory guidance. The rationale for this position is that the qualifications needed vary greatly, depending on the scope of the program.
The Advisory Committee on the Medical Uses of Isotopes (ACMUI) discussed the ANPR during its meeting in May 1996. The Committee commented that the draft ANPR and background material had many references to the recent contamination incidents at the National Institutos of Health and Massachusetts Institute of Technology. There was concem that the ANPR was based on these incidents and that the staff was reacting to events that the licensees may not have been able to prevent. The staff indicated that there were discussions regarding revisions of Part 33 before these events. The ACMUI recommended that the staff reconsider the emphasis in the background information presented in the ANPR to avoid the appearance that NRC was reacting to these events. Overall, the ACMUI believed the draft language in the ANPR to be too prescriptive and that broad scope licensees, by definition, are trying to achieve a maximum level of flexibility. The ACMUI, during its April 1997 meeting, recommended retention of the current regulatory approach for Part 33. A copy of the minutes for this meeting is provided in Attachment 3.
Because of the negative response to the ANPR, including the recommendation of the ACMUI, the staff is proposing to terminate the rulemaking effort for Part 33. In lieu of rulemaking, the staff is proposing to finalize draft guidance currently contained in Draft Regulatory Guide DG 0005,
- Applications for t.lcenses of Broad Scope, Revision 2."
This guidance will be finalized as a NUREG as part of the ongoing guidance updating and consolidation project.
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3 The Commissioners 3
The guidance discussos the role and responsibilities of licensee management, emphasizing that strong management controls and oversight are needed to ensure that licensed activities are conducted properly. The guidance also stresses the importance of devoting sufficient resources to support the radiation protection program. The roles of the RSO and the RSC, their respective duties and responsibilities, as well as the qualifications needed for the RSO, are also addressed in the guidance.
Broad scope licensees currently have the flexibility to make changes in their program, such as
' naming authorized users; having broad authorization for radionuclided with atomic numbers 3-83; changing locations of use within the facility; and decommissioning of previously use areas. Broad scope licensees generally submit detailed information about their proposed operating procedures and radiation safety program in their initial application for a broad scope license. This information is included in the license under a " tie-down' condition. As part of this project, the staff plans to evaluate the licensing process and license conditions for ways to provide greater flexibility for broad scope licensees to modify their programs without seeking a license amendment.
The Commission, in an SRM dated September 18,1996, directed the staff to include a question of separation of contamination risk versus extemal radiation risk. The staff received 15 comment letters on this question, all of which opposed addressing this issue in rulemaking.
The commenters believe that there is no need for special considerations for intemal exposure to include a separate or different intemal or external dose limit. A detailed summary of the comments on this question may be found in the comment analysis provided in Attachment 2, question 5, on page 5.
The staff received 11 comments on the question of MMLs in the ANPR Eight of the 11 commenters opposed incorporating these requirements within Part 33. An MML is not a true broad scope license. An MML is a license which authorizes a single entity, such as a Federal agency or military organization, to issue permits for new facilities of use, conduct enforcement, and perform oversight inspections or audits for facilities at multiple sites in multiple regions. All permit reviewers and inspectors must be fully qualified according to the guidelines in Manual Chapter 1246, "Formai Qualification Programs in the Nuclear Material Safety and Safeguards Programs Area,' identical to NRC staff. NRC does not review or approve new users or locations, and does not inspect the permitted facilities under the routine inspection frequency for that type of facility. NRC does conduct an annualinspection of the MML to review the management, inspection permitting, and enforcement activities performed under the license.
Additionally, NRC inspectors accompany MML inspectors on certain inspections as part of our review of the MML. While broad scope licensees approve their own users, they differ from an MML in that a broad scope licensee must apply for an amendment when adding new facilities of use and they cannot conduct their own inspection and enforcement program. Therefore, the staff has decided that the MML process should not be codified within Part 33.
The Commission, in an SRM dated September 18,1996, recommended that the staff address the issue of whether non-Federallicensees may obtain an MML. The staff discussed this issue in a memorandum to the Commission, dated June 4,1997 (Attachment 4). To summarize,
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although there is no prohibition in the Atomic Energy Act against private entities obtaining an MML, there are State and Federallegal and policy implications involving the role of the Agreement States. Agreement States have jurisdiction over the types of materials that would be covered by an MML for a private entity. This creates a jurisdictional problem in establishing an MML for a licensee having facilities within NRC and Agreement State jurisdiction. On September 25,1997, the staff distributed Re cion 1 to Policy and Guidance Directive (PGD) e i,-02, ' Guidelines for Evaluating Programs for Master Material License Applications,' which is an extensive standard review plan on the MML process, and is available to licensees (Attachment 5) The revision to PGD 6-02 specifies that MMLs will only be issued to Federal faci lities, which addresses the jurisdictional issue staff raised in the June 4,1997, memorandum to the Commission. The staff will continue to review applications for an MML on a case by-case basis, using PGD 6-02, Revision 1.
SCHEDULE and RESOURCES:
If the Commission approves this plan, the staff plans to begin finalizing the dre.' guidance in April 1998. A draft NUREG will be published August 1998, for a 90-day comment period. Any comments received will be resolved and incorporated into the final NUREG. The staff plans to publish the final NUREG in April 1999. A Gantt Chart outlining this schedule is provided in.
The guidance will be finalized as part of the guidance consolidation project, following the approach developed during the business process re-engineering effort. The proposed project will require a combined total of less than 2.5 FTEs from Headquarters and the regions. These resources are available within the cuirent budget.
RECOMMENDATIONS:
The staff recommends that the Commission approve termination of the proposed rulemaking for Part 33, and approve the finalization of draft guidance in a NUREG. The staff will publish the appropriate notice of termination of rulemaking in the Federal Realster. Informing the public that NRC is not going forward with a proposed rulemaking for Part 33 and that the staff plans to finahe draft guidance in a NUREG. Any comments received in response to the notice will be considered in the development of the final guidance.
4 COORDINATION:
The Office of the General Counsel has no legal objection to this paper The Office of the Chief Financial Officer has reviewed this Commission Paper for resource implications and has no I
objections.
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}H L( J ph Cellan EA ive Director for Operations Attachments: 1. SRM did 9/18/96
- 2. Comment analysis
- 3. Minutes - 4/97 ACMUI mtg l
- 4. Memo did. 6/4/97
- 5. PGD 6-02
- 6. Gantt chart Commissioners' ccmpleted vote sr.eets/ comments should be provided directly to the Office of the Secretary by cob Tuesday, February 17, 1998.
Commission staff office comments, if'any, should be submitted to the Commissioners NLT February 9, 1998, with an information copy to SECY.
If the paper is of such a nat'ure that it requires additional review and comment, the Commissioners and the Secretariat should_be -
apprised of when comments may be expected.
DISTRIBUTION:
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Sep tctr.be r 18. 1996 BShelton, IRM MLesar, ADM 0"'c t or TH pHolahan, NM55 SLCR t t A F4 Y MEMORAllDUM TO:
James M. Tayle-Executive Director for'Operatier.
FROM:
John C. Hoyle, Secretary '
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SUBJECT:
STAFF REQUIREME!JTS - SECY-96-167 - SPECIFIr DOMESTIC LICE!1SES OF BROAD SCOPE FOR BYPRODUCT MATERI AL - ADVA!JCE IJOTICE OF PROPOSED RULEMAKIliG l
l The Commission has approved publication of the Advance liotice of Proposed Rulemaking ( AllPR) in the. Federal Recister subject to incorporation of the following comments.
1.
A detailed definition of the term " broad scope" should be added to the rule language.
2 The question of separation of contamination risk versus external radiation risk should be posed to the public.
3.
A discussion and' request for ccmments on what balance the NRC should strike between a performance-Pased and a prescriptive approach to regulating broat. scope licensees should be included in the AliPR.
In the specific context of regulating such licensees, the clocussion should state what liRC means by performance-based regulation and prescriptive regulation and should identify the principal issues associated with each of these regulatory approaches.
- / Mo w e
- t EDO)::
(NMSS)
(SECY Suspense:
11/1/96) 9600144 The staff should consider, while not delaying publication of the ANPR, directly addressing the issue of whether non-Federal licensees may obtain master materials licenses.
This is an important policy issue in that only federal agencies already have master materials licenses.
-f EDO) -
(NMSS)
(SECY Suspense:
4/25/97) 9600145 M %co?Q SECY 110TE:
THIS SRM, SECY-96-167, AND THE VOTE SHEETS OF ALL COMMISSIONERS WILL BE MADE PUBLICLY AVAILABLE 5 WORKING DAYS FROM THE DATE OF THIS SRM.
2 Concurrent with the development of
- 0 CFR Part 33, the staff shuuld also consider finalizing any guidance on broad scope licensee Radiation Safety Officer (RSO) training and experience contained in draft regulatory guides.
By finalizing the guidance, licensees will know what type of " specific training in radiation health sciences" and what type of experience is appropricio for broad scope licensee RSos.
This shouJd be provided for Commission review with the proposed rule.
(-BGG 4 NMSS (SECY Suspense:
12/31/97) 9600144
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cc:
Chairman Jackson Commissioner Rogers Commissioner Dicus Commissioner Diaz Commissioner McGaffigan OGC OCA OIG Office Directors, Regions, ACRS, ACIN, ASLBP (via E-Mail)
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NUCLEAR REGULATORY COMMISSION e
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'+, * * * * *,o March 20, 1997 MEMORANDUM TO:
Carl J. Paperiello, Director Office cf Nuclear Material Safety And Safeguards FROM.
David L. Morrison, Director Office of fJuclear Regulatory Research ' /f'c
SUBJECT:
USER NEED MEMORANDUM FOR 10 CFR PART 33 in response to your user need memorandum dated January 16,1997, for 10 CFR Part 33, the attached public comment analysis is forwarded for your information and use. It is anticipated that the draft rulemaking plan will be ready fur your concurrence by April 30,1997.
Attachment:
As stated
PUBLIC COMMENT ANALYSIS FN 9 CFR PART 33 An Advanced Notice of Proposed Rulemaking (ANPR) was published in the Federal Reaister (61 FR 58346) on November 14,1996, relating to 10 CFR Part 33, " Specific Domestic Licenses of Broad Scope for Byproduct Material." Public comments were requestcd by February 12,1997.
A total of 22 comment letters were received from the following:
Comment Number Commenter 1.
The University of South Carolina 2.
University of Califomia, Los Angeles, School of Medicine 3.
US Department of Commer:e - National Institute of Standards and Technology 4.
American College of Nuclear Physicians - Califomia Chapter 5.
State of Illinois Department of Nuclear Safety 6.
Council on Radionuclides and Radiopharmaceutical, Inc.
7.
Indiana University Medical Center 8.
University of Wyoming 9.
Pharmacia & Upjohn, Inc.
10.
Amersham Holdings, Inc.
11.
The Rockefeller University 12.
Abbot Laboratories 13.
Merck & Company, Inc.
14.
University of Califomia, San Francisco 15.
Massachusetts institute of iachnology, Medical Department 16.
Mayo Clinic 17.
Health Physics Society 18.
3M Health Physics Services 19.
Private Citizen - Certified Health Physicist 20.
Private Citizen 21.
DuPont Experimental Station, DuPont Stine-Haskell Research Center, and DuPont Merck Glenolden Laboratory 22.
NationclInstitute of Health The Advanced Notice of Proposed Rulemaking asked the public to comment on 11 specific questions along with draft rule language. The following analysis provides a list of the questions, a summ uy of the public comments along with a quote from the comments that generally characterized the responses to the specific questions. Comments on specific regulation l
language were provided by only a few commenters and will be tvaluated when developing the l
proposed rulemaking package.
2 General Comments:
Of these 22 comment letters received,15 provided an overview of the rulemaking effort outlined in the Advanced Notice. Thirteen (13) were anerally against proceeding with the rulemaking while 2 were partially in favor of the rulemaking.
Support of the proposed rulemaking effort could canerally be characterized by the following quote:
"In general, we agree with NRC's proposal to amend 10 CFR Part 33 to clarify the regulations goveming specific licenses of broad scope for bypro6sct material. Most broad scope licenses are very diverse in their use and management of byproduct material which is specific to the individual needs of the licensee. Therefore, it would be impracticable to present prescriptive requirements that would be applicable to all broad scope licensoes.
This diversity of individual licensees, combined with the fact that most broad scope licenses are issued to organizations who have the expertise and have already demonstrated the capability to effectively manage their radiation safety programs, necessitate that these regulations be more performance based and loss prescriptive wherever possible.
Performance based standards would empowe:r the licensee to continually develop improved methods of managing their radiation safety programs based on their own needs.
Opposition to the proposed rulemaking effort could generally be characterized by the following quotes:
"The Califomia Chapter, American College of Nuclear Physicians sees no valid reason for the proposed changes to 10 CFR Part 33 and urges that they not be adopted. In addition, this whole concept is in direct opposition to the recommendations of the NAS-lOM, whose opinion was sought by NRC. The costs for this study, $1.25 million, were bome by NRC medical licensees who wish to see the NAS-lOM advice implemented."
"In the background section of the Advanced Notice of Proposed Rulemaking for Specific Domestic Licenses of Broad Scope for Byproduct Material, it is stated that "the current program goveming the regulation of specific licenses of broad scope for byproduct material has worked ag]l to provide for public health and safety from these licensed activities." We agree. Only 38 events involving broad scope licensees occurred that resulted in some tyr.e of enforcement from 1993-1996. This is an excellent track record when compared against the many man hours that were logged during that period of int.ividuals working with radioactive material at broad scope programs. Many of the aforementioned 38 events that resulted in enforcement involved loss of comrol of radioactive material, release of materialin excess of the limits in 10 CFR 20, or contamination outside of the work area. Although these are not desirable results, the NRC should examine these incidents and evaluate their significance in terms of risks to employees and the public. The smallincrementalincrease in risk that these incidents posed do not justify overhauling the broad scope regulatory framework that has proven effective for many years.
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3 Soecific Comments:
Question 1 Should the responsibilities of Licensee Management for the Radiation Safety Program be specified in Part 33?
17 comment letters responded to this question,2 supported the staffs proposal while 15 opposed the staffs proposal.
l Support of the proposed rule change could generally be characterized by the following comment:
"This will lead to a standardization of the industry such that all institution and facilities with broad scope licenses have common practices and review standards. This will aid the smaller institution or facility, with limited resources, to concentrate on those areas that pose a significant risk if not managed property. Larger facilities will spend less time on insignificant issues thereby saving time and money "
Opposition to the proposed rule change could generally be characterized by the following comment:
"The specific responsibllities of licensee management should not be included in the Federal regulations. The role of management in a small private research laboratory is very different from that of a multi-collegiate state-funded university or medical center To try to come up with blanket ".tatements regarding management at both of these types of businesses ignores their Gierences and disallows any fled!!ity la creating effective radiation safety programs, if anything at all should apgar in the regulations themselves regarding managerial responsibilities it should be a general statement that management -
is ultimately fiscally and administratively accountable for compliance with regulatory and license conditions."
Question 2 Should the Nuclear Regulator, Commission (NRC) incorporate requirements for the duties and responsibilities of the Radiation Safety Officar (RSO) and the Radiation Safety Committee (RSC)?
17 comment letters responded to this question 2 supported the staff's proposal while 15 opposed the staff's proposal.
Support of the proposed rule change could generally be characterized by the following comment:
The requirements of the duties and responsibilities of the Radiation Safety Officer and Radiation Safety Committee should be stated in Part 33. The responsibilities should be stated in terms of performance-based requirements as much as possible rather than prescription based."
4 Opposition to the proposed rule change could generally be characterized by the following comments:
"The overall objectives of the RSO and RSC should be provided in Part 33; while regulatory guidance should provide examples of qualifications, duties and responsibilities.
Necessary qualifications vary greatly depending on the licensees' program and the duties and responsibilities assigned to the RSO and RSC. It is not feasible to provide one set of criteria that would be appropriate for all broad scope licensed facilities."
"No. A program of twenty or forty authorized users does not require the same caliber of RSO as one with ten times that many and a medical center. Nor would the RSOs of each of these institutions necessarily have the same duties. In a small program, radiation safety is a one-man operation. In a larger program the duties must be spread over several managers."
- NRC should avoid specific, prescriptive requirements for the duties and responsibilities of the RSO and RSC. These requirements, as well as minimum requirements for training and experience, will be dependent on the scope of the licensed activity. All RSO and RSC requirements, including minimum training and experience, should be commensurate with the licensed activity and reviewed during the application / approval process "
Question 3 Should specific minimum training and experience criteria for authorized users be incorporated into Part 337 17 comment let.ers responded to this question. 2 supported the staff's proposal while 15 opposed the staffs proposal.
Support of the proposed rule change could generally be characterized by the following comment:
"The specific minimum training requirements listed in Sec. 33.15(b)(1) arsd (2) are reasonable and include references to the specific scope and use of the license.
Establishing similar training. aquirements for users under Type A or B licenses is reasonable and may be served by either including them in the regulations or by addressing them in guidance documents."
"The qualifications for the RSO should be commensurate with the proposed types, quantities, and uses of the radioactive material. A broad scope license by design allows cc~i*rable latitude on the uses of radioactive materials. Therefore, the qualifications for the RSO should be somewhat rigorous to assure the protection of public health and safety. We recommend that the NRC set high standards for training and experience with the expectation that highly trained individuals are more likely to run a rigorous program that protects public health and safety. We would support RSO training requirements of a nature similar to those of 10 CFR 35.900, which include certification by the American Board of Health Physics as one means for individuals to demonstrate their competer:cy in radiation protection. While training requirements in the proposed Sec. 33.21(b) may be sufficient for a specific license of limited scope, we question whether they are sufficiently rigorous to assure that highly qualified individuals would be appointed by licensee
5 management to the important position of /RSO for a broad scope license. Ar, individual, j
who is certified by the American Board of Health Physics or a similar professional organization, or someone who has completed training similar to that specified in 10 CFR 35.900(b) is more likely to have the knowledge and insight expected to adequately protect public health and safety from asities associated with a broad scope license."
l Opposition to the proposed rule change cohld generally be characterized by the following comment:
"It is not practicable to specify training and experience criteria in 10 CFR 33 that would be appropriate for alllicensees. Instead we recommend that the NRC provides guidance on qualifications for key personnel in Regulatory Guide 10.5."
" Training and experience requirements for authorized users will vary depending on the scope of the licensed activity and the individual authorized user's role within the facility (certain authorized users may only be permitted to use limited amounts of byproduct material within an organization), Minimum requirements could be addressed in guidance documents but, ultimately, the specific requirements for these users are better determine < by the RSO and RSC."
l l
Question 4 l
Should the NRC incorporate specific requirements for inventory and accountability of byproduct material in use, or n.odify its existing guidance?
I 16 comment letters responded to this question. 2 supported the staffs proposal while 14 opposed the staffs proposal.
Support of the proposed rule change could generally be characterized by the following comment:
" Inventory and accountability of byproduct material, particularly sealed sources, should be a fundamental requirement for any licensed operation. Existing guidance may be modified to clarify acceptable methods for assuring accountability of byproduct material, but care should be taken to incorporate flexibility to permit licensees to develop methods that are most suitable to their needs."
" Establishment of regulations for the control of material should be based on the hazard of the material. For instance, the cost and effort to lock up or secure less than some fraction of an All may exceed the benefit. Specifying a quantity (some fraction of an All) as requiring a lesser degree of control would help the licensee concentrate efforts on controlling quantities of materials that matter, rather than locking up and worrying about every nanocurie of material."
Opposition to the proposed rule change could generally be characterized by the following comment:
" Current regulation and guidance on the inventory and accountability of byproduct materialis adequate. Because of the variability in the way byproduct material is used in industry and academia, a knee-jerk reaction by the NRC, to the criminal actions of one or
6
- two people, may unnecessarily burden many other licensees who have demonstrated good performance."
"This topic reites the greatest possibility of being a needless manpower drain of radiation protection resources. _While the regulations clearly require, and there is a clear need to, control alllicensed material there is clearly a difference in the degree of austerity needed between low-level, low-toxicity sources and the opposite extreme. Given the added variable of a wide variety of kinds of licensees we judge that this issue is best left to the licensing and inspection process. Any sort of comprehensive rule is certain to be
. Inadequate for a significant number of licensees."
Question 5 Should the NRC considei tt'e risks associated with intemal exposure pathways (e.g.,
ingestion, inhalation, absorption) separate from those associated with extemal radiation?
)
' 15 comment letters responded to this question. No commenters supported the staff's amposal while 15 opposed the staff's proposal.
Opposition to the proposed rule change could generally be characterized by the following comment:
s "The 10 FR 20 revision which rectified this historical error should not be undone. In virtually all cases generic intemal modeling is an overestimate of the individual's exposure. And in the cases specifically cited the dose estimates were certainly as good as extemal dose estimates in analogous events. if anything, under the current rules -
- intemal dose risks for the typical worker are more realistically estimated than extemal exposures (by the very definition of these doses in Part 20) so that added special
- considerations for intema! exposure are not needed.'
' The current NRC practice for considering risk from intomal and extemal exposure is compatible with recommendations of the National Council on Radiation Protection and Measurements and the Intemational Commission on Radiological Protection. This current practice is appropriate because the risk from committed effective dose from intemal exposure is defined to be generally equivalent to the risk from a similar extemal -
dose.- Hence, there is no need for a separate or different intemal or extemal dose limit."
"The revisions to 10 CFR 2L. vere based in part on recommendations by the ICRP and NCRP, after twenty years of consideraticc and debate, it was expensive for the govemment and licensees to make these changes in written policies, training, dosimetry records and guidance documents. To go against these recommendations after only two isolated events would be a costly knee-jerk reaction."
Question 6 Are there other specific aspects of the Draft Regulatory Guide DG-0005 that should be codified in Part 33?
16 comment letters responded to this question. No commenters supported the staff's proposal while 16 opposed the staff's proposal.
e 7
Opposition to the proposed rule change could generally be characterized by the following
{
comment:
"We do not recommend that any guidance in Draft Regulatory Guide DG-0005 be codified in 10 CFR 33. We believe that the guidance provided in Draft Regulatory Guide DG-0005 is better presented as guidance than specified as a regulatory requirement. Specific requirements can be addressed more effectively as license conditions."
"No. There are many fine pieces of information in the draft guide. With some editing and clarification this guide can provide excellent guidt nce and useful policy. Proper use of the guide, standard review plan, and pre-licensiny visits by license reviewers can ensure that the licensees own document is strong enour h and flexible enough to ensure an adequate radiation safety program."
"The only addition to 10 CFR 33 should be the inclusion of intemal exposure control programs as a requirement to allowing a licensee to continue operations."
Question 7 Should broad scope licensees be allowed to make changes in their radiation safety program similar to those authorized for production and utilization facilities in 10 CiR 50.59?
18 comment letters responded to this question.11 supported the staffs proposal while 4 opposed the staffs proposal.
Support of the.
. ad rule change could generally be characterized by the following comment:
"The NRC also provides for changes in Emergency Plans without formal license amendment. Current practice for making changes to radiation protection programs should be defined in 10 CFR 33. We urge that such changes should just be documented by the licensee and that only when license conditions are changed, there should be a requirement for notifications to and authorizations by the NRC. Many licensees find it necessary to make frequent minor changes to their radiation protection programs. The ability to make these changes without formal application for license amendment avoids involving the NRC in a large number of trivial licensing actions. Another advantage is that it will encourage licensees to take advantage of rapidly changing technical improvements that can improve licensee performance in radiation protection."
"Yes, they should, but not entirely in the way suggested in the Federal Register. We have had the authorization under our license to make " ministerial" changes to our radiation safety program for almost four years and it has worked well for us. The conditions are almost the same as those in the proposed section 33.59 with some important exceptions.
First, the letter incorporated into our license better describes what types of changes would be considered ministerial and what changes require a license amendment. This is a helpful detail, which might better be addressed in a guidance instead of codified regulations. Second, the reporting requirements under paragraph 33.59(b)(2) are not a condition of our license. If complete records are kept and the changes are approved by the Radiation Safety Committee a full report to the NRC within 30 days of the change is an unnecessary waste of time and paper."
8 "The level of expertise involved in maintaining a broad scope license should enable a significant amount of flexioility to make changes to their radiation safety program within the scope of their operation as long as licensed radionuclides, maximum possession limits and physical boundaries of the facility are not exceeded. The individual licensee'c criteria for their review and approval of these changes can be specified in their license application, and their performance of these duties assessed during inspections."
- Opposition to the proposed rule change could generally be characterized by the following comment:
"This is best demonstrated in the NRC's own words: " Generally, the current program goveming the regulation of specific licenses of broad scope for byproduct material has worked well to provide for public health and safety from these licensed activities." NRC goes on to state that there were only 38 events in a 4 year period that restilted in some type of enforcement action. Even though these events did not apparently imperil the public health, the NRC is concemed that such events "could potentially result in doses to the public from radioactive material." The NRC Jumps from what didn't happen to what "could potentially" happen and then jumps to a proposal to equate certain aspects of a 4
broad scope license to a license for a nuclear power plant. If the NRC is so concemed with "could potentially,"it should decrease its regulation of Medicine and Pharmacy and focus its efforts on power reactors, where "could potentially" represents a true nightmare."
Question 8 Should the dif'erent types of broad scope licenses currently in Part 33 (Types A, B and C) be deleted and replaced with a single type?
13 comment letters responded to this question. 3 supported the staff's proposal while 10 -
opposed the staff's proposal.
Support of the proposed rule change could generally be characterized by the following comment:
"All types of broad scope licenses should be replaced with a single license type which is most similar to the current Type A Ucense of Broad Scope. The autonomy granted under Type B licensu has been largely for the naming of additional users by the RSO.
Allowances can be made under specific licenses to achieve this end, provided commitments regarding training and experience of authorized users are submitted by the applicant. The table values of radionuclides for Type B and C licenses are of little value when establishing these licenses of broad scope as licensees typically request to vary from the activities authorized by the table values for certain radionuclides. Our experience mimics that of the US NRC with regard to distribution of broad scope licenses over the various types. Establishment of a single type of broad scope license and a common set of requirements would provide clear requirements to licensees as well as aid in the streamlining of licensing and inspection of these licenses."
Opposition to the proposed rule change could generally be characterized by the following comment:
____._______m______-
1 g
4, g
L-
- No. This would averely limit smaller facilities and institutions to an unnccessary set of l
-. rules which would be very costly to the institution and the. govemment."
9 "The NRC should not eliminate Type B and C broad scope licenses in favor of Type A.
We believe that Type B and C licenses are needed for efficient management of programs i
having a broad scope of activities but limited byproduct materials needs. The imposition D
- of Type A administrative controls on successful Type B and C licensees would add unnecessary burden, delays, and ultimately costs without benefit."
Question 9 Should s category for " Master Materials Licenses" be incorpcmted into Part 33 with the respective necessary requirements?
9 comment letters responded to this question. - 1 suppc ted the stars proposal while 7 opposed the stafs proposal.1 commenter asked a question, "Would this be useful for licensees other than Federal organizations? Would it be useful to licensees that answer to different jurisdictions?"
2 l
Support of the proposed rule change could generally be characterized by the following comment:
d "It's incumbent upon the NRC to ensure the regulations under its jurisdiction reflect the methods it is using to regulate the use of byproduct material. As such, the " master.
j
- lic.,.nse" philosophy should be codified."
Opposition to the proposed rule change could generally be characterized by the foll%ng comments:
- The # master materials license" that has been utilized for the armed services has " worked
- well" according to the NRC. There is no need to codify the masters materials program until there is more experience in evaluating and regulating such new programs."
"This is an academic issue.- The added layer of bureaucracy is a clear detraction from choosing this category unless the licensee is a very large, and probably multistate organization. And in that event,- the idiosyncrasies of the different states are an added distraction to this option unless the licensee is like the examples cited, e.g., exempt from L
state licensing by virtue of being a Federal entity."
"We have no comment regarding the establishment of Master Material Licenses as long -
-as they are restricted only to locations / facilities of Departments and Agencies which are l
under exclusive Federal jurisdiction."
"In some cases this might make regulating these license locations more difficult. We e
. have USDA labs housed on our University campus, which is a common practice. These -
labs used to be regulated under USDA master license. More recently, however, an agreement was mads with the USDA, the University and the NRC to place these
- laboratories under the University's NRC license. This has enhanced cooperation between the agencies involved and has made control over radionuc,lide usage in these
]-
facilities much simpler."
a 1
10 "It would seem unnecessary to incorporate a "Ma:ter Materials License"into Part 33 considering the relatively few licenses of this type that would be needed. These licenses could continue to be issued on a case-by-case bas s with the review of requirements based on the overall scope of the proposed activity."
"I see no significant advantage to a " master" category versus a broad license such as that issued to MIT."
"No. If this category is to be codified a stand alone Part, would be more appropriate to avoid confusion with a broad scope license."
Question 10 Should requirements for " Multi-Site Facilities" be codified in Part 33 or should this be defined only in 10 CFR Part 30?
8 comment letters responded to this question.1 supported the staffs proposal while 7 opposed the staffs proposal.
Support of the proposed rule change could gonerally te characterized by the following comment:
"It appears that the regulations covering a multi-site license will b3 in addition to those specified in 10 CFR 33, under the type " specific licenses of bre'd scope." As such, the requirements for multi-site licenses should be included in thic part."
Opposition to the proposed rule change could generally be characterized by the following comment:
"It is fine as is in Part 30. NRC should stop trying to create unnecessary work for itseli which our licensees must subsidize with absurdly high User Fees."
"I see no problem with the way multi-site facilities are currently licensed, assuming that a single license will continue to be allowed for similar activities under a common protocol for multiple site applications."
Question 11 What balance should be maintained between a performance-based and a prescriptive approach to regulating broad scope licensees?
17 comment letters responded to this question.17 letters supported the staffs propuoal for performance-based regulations while no commenters opposed the staffs proposal.
Support of the proposed rule change could generally be characterized by the following comment:
"It appears a good balance has been adopted in the drafted regulatory language in order to limit the expend lture of limited resources associated with an inspection intensive program, regulations have been developed which require the submission of a framework
11 of applicant prepared procedures and policies. In the past, measurement of end goals.
was difficult at best, in that several policies and procedures were not specifically required and programs varied widely in their smpe and implementation. To this extent a.
prescriptive approach has been adopted. However, in recognition of a need for performance based regulation, allowances have been given to the licensee to develop procedures which would best suit them. The major benefit of a license of broad scope is its flexibility, which is difficult to authorize under a prescriptive approach. A program based on an active management and RSC, competent RSOs and authorized users, self audits, personnel monitoring, incident control and response and a.'re monitoring for radiation levels and contamination should be encouraged and verified through routine, i
frequent compliance inspections. As stated in the draft regulatory language, a license should be granted in part based on past performance. Further, it should be noted that
. this privilege of"self regulation"is subject to revocation or modification pursuant to inspection and enforcement."
"I agree with the NRC staff that a risk-informed, performance based regulatory approach should contain the elements of measurability and objectivity. Rose factors do not l
necessarily have to be written into the regulations, but cari vasily be described in the l
individuallicense. The element of flexibility in meeting performance criteria can only exist -
if the codified regulations allow that flexibility. It is then up to the NRC inspection branch, working with the licensee, to determine if performance criteria are actualN being met in the manner intended, if programs with limited budgets are directed to folluv rules that do not take actual risks into account, their only choices are to either sacrifice otaer more serious safety concems or be out of compliance with the regulations."
"We recognize that certain elements of a regulation must be somewhat prescri3tive to assure that radioactive materials will be utilized only by appropriately trained individuals in appropriately designed facilities. On the other hand, regulations that are overly l
prescriptive increase the cost of radiation safety programs without a concomitant increase ir, safety.- Many members of the society have experience in the implementation of 10 CFR Part 35 which incorporates a very prescriptive approach to essentially all elements of the medical use program. The overwhelming consensus of opinion based on this experience is that the prescriptive nature of 10 CFR Part 35 has significantly increased the effort required to maintain comp &m without a concomitant increase in safety. A performance ;ased approach would
..sw more flexibility in the design of radiation safety programs but still require that certain radiation protection benchmarks be met. Therefore, while we support a prescriptive approach to tia training and experietr requirements for RSOs and authorized users, we strongly encourge the Commissius to.
adopt a performance based approach to the program as a whole."
Lastly, the ANPR requested public comments on the costs and benefits, normu ousiness practices and new trends that should be considered in the regulatory analysis. done of the commenters specifically provided input to this question.
us.,
12 Summarv Generally speaking, a vast majority of commenters were against any new rer stations in 10 CFR Part 33, " Specific Domestic Ucensees of Broad Scope for Byproduct Materia;,
- and strongly felt that the costs would clearly outweigh the benefits. Most commenters strongly supported accomplishing the rule change through a revised regulatory guide.
Nonetheless, if the Part 33 rulemaking must continue, the commenters strongly felt that the regulations should be flexible, performance-based and that the staff should avoid specific prescriptive requirements, i
+n atooq y
UNITED STATES j
NUCLEAR REGULATORY COMMISSION 2
WASHINGTON, D.C. 20555 4 21
'+4..... g hay 1, 1997 o
MEMORANDUM T0:
Chairman Jackson Comissioner Rogers Comissioner Dicus Comissioner Diaz Comissioner McGaffig n FROM:
L. Joseph Calla ExecutiveDirectorgarOperations 3
SUBJECT:
SUMMARY
MINUTES OF THE MEETING 0F THE ADVISORY
]
COMMITTEE ON THE MEDICAL USES OF ISOTOPES HELD ON APRIL 10 AND 11. 1997 Attached are the summary minutes of the meeting of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) held on April 10 and 11, 1997. Also attached is a summary of the major items discussed in the minutes (Attachment 1).
This information serves to address the Commission's interest in the ACMUI's preliminary views regarding Direction Setting Initiative 7 and the Staf f Requirements Memorandum - COMSECY-96-057, in preparation for the ACMUI May 8,1997. Commission Briefing.
Attachments: 1.
Summary of Major Issues 2,
ACMUI Minutes, dtd 4/22/97 cc:
SECY OGC OPA OCA CONTACT: William B McCarthy NMSS/IMNS (301) 415-7894 l
0 4
O Attacittnent 1
SUMMARY
OF MAJOR ISSUES There were three votes during the day and a half meeting, the ACMUI recommendations are as follows:
The ACMUI recommended by a 9 to 1 vote that Statements 2 and 3 of 1979 Medical Policy Statement be revised to read as follows (note that the bold is the recommendedadditionsandthebracketed{}textremoved):
Statement 2: The NRC will regulate the radiation safety of patients only where justified by the risk to the patients, and only where voluntary standards or compliance with these standards are inadequate. Assessment of the risks justifying such regulations will reference comparable risks and comparable modes of regulation for other types of medical practice.
Statement 3: The NRC will { minimize intrusion} not intrude into medical judgements affecting patients and into other areas traditionally considered be a part of the practice of medicine.
The dissenting vote was cast by Ms. Brown. She indicated that the current Medical Policy Statement is adequate and that no changes were needed The ACMUI brought the following motion to the table: "ACMUI recommends retention of the current regulatory approach for [Part] 33."
The vote was 9 for and 1 opposed.
Dr. Williamson stated in opposition that "[he does not]
feel able to assess the rigidity and flexibility of the current process relative to what might happen at this time."
The ACMUI brought the following motion regarding the Quality Management inspection procedures to the table: "[the ACMUI recommends that the NRC]
i modify the OM inspection procedures with the intent to reflect the spirit of the Commission direction in the M;i [regarding DSI 7]."
The vote was 9 for the motion and 1 abstention. Judi'h Brown abstained because she was not familiar with all of the elements of the issue. Dr. Wagner wished to go on the record stating that the OM rule as a regulation was unnecessary.
In addition to the three formal votes by the Committee, they also discussed at great length the definition of risk, and were not able to reach closure in a definition and how to apply risk over-all.
42 arco f
'o&
UNITED STATES y
g
}
NUCLEAR REGULATORY COMMISSION o,
WASHINGTON, D.C. 20555o001
%,'****/
MEMORANDUM TO:
Donald A. Cool, Director Division ofIndustrial and l
MedicalNuclear Safety, NMSS FROM:
Judith Anne Stitt, M.D., Chairman Advisory Committee on the Medical Uses ofIsotopes
SUBJECT:
CERTIFICATION OF THE MINUTES OF THE b
MEETING OF THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES I hereby certify that, to the best of my knowledge and belief, the attached minutes for the meeting of the Advisory Committee on the Medical Uses ofIsotopes (ACMUI) held on April 10 and 11,1997, are an accurate record of the proceedings for that meeting.
we W u/b~ (b'&Y~
L Judith Anne Stitt, M.D., Chairman
-j.'_ Q G;7 Date
Attachment:
Minutes - ACMUI mtg.
4/10-11/97
2 Minutes of the Spring Meeting of the Advisory Committee on the Medical Uses ofIsotopes i
~
April 10 and 11,1997 The Advisory Committee on the Medical Uses ofIsotopes (ACMUI) held a meeting on April 10 and 11,~ 1997. A briefmg book with background information for the issues under discussion was provided to the ACMUI members in advance of the meeting, and is available through the Public Document Room.
,j ACMUI members present at the meeting:
Judith Ann Stitt, M.D., Chairman Judith Brown Daniel F. Flynn, M.D.
John Graham Andrew Kang, M.D.
Will B. Nelp, M.D.
. Dennis P. Swanson, M.S., B.C.N.P.
Louis K. Wagner, Ph.D.
- Theresa Walkup, C.M.D.
Jeffrey F. Williamson, Ph.D.
Also present: Larry W. Camper, M.S., M.B.A., Branca Chief, Medical, Academic, and Commercial Use Safety Branch, Nuclear Regulatory Commission (NRC), (Designated Federal E
Official for the Committee); Donald A. Cool, Ph.D., Director, Division ofIndustrial and Medical l
- Nuclear Safety, NRC; and Cathy Haney, M.S., Section Leader, Medical and Academic Section, J
L
- NRC. Barry Siegel, M.D.; Aubrey Godwin; and Larry Satin, M.D. also attended the meeting as I
invited guests, representing nuclear medicine, the States' perspective, and Nuclear Cardiology respectively.
Mr. Camper officially opened the meeting at 8:17 a.m. with general comments on the meeting and the function of the ACMUI. Mr. Camper stated that he had reviewed the Committee members' fmancial and employment interests, and had not identified any conflict ofinterest with items to be considered during the meeting. Mr. Camper stated that any ACMUI member who becomes aware of a potential conflict ofinterest during the course of the meeting should so inform him or Dr.-
Stitt.
Donald A. Cool, Ph.D., made opening remarks to the Committee regarding the upcoming revision of Part 35 and the Committee's involvement. He stated that NRC is about to take a fundamental re-examination and re-crafting of the regulations pertaining to the medical uses ofisotopes.- This will involve a whole new view, "a white piece of paper", at regulating the medical use of -
radiation. The now revision of Part 35 will be risk informed an:1 performance based.
Commissioner McGaffigan addressed tlee Committee. The Commissioner stated that he was there to give insight of how the Commission came to their decision regarding DSI 7. The Commissioner also discussed various topics including: the IOM report; DSI 12; linear no-threshold hypothesis (LNT); and ACMUI's input to the revision of Part 35. The Commissioner noted that regulations can not be totally non-prescriptive but we should strive to be as performance based as possible. He also requested that the ACMUI give their input to the staff early.
1
2 Hugh Thompson discussed how the other NRC Advisory Committees operate in comparison with ACMUI. Mr. Thompson noted that the ACRS has a full time NRC staff to deal with the Committee actions and each Committee member spends about half of their time on work related to ACRS. This is in comparison to the ACMUI which is supported by staffin NMSS. On this same topic he encouraged the Committee to give their input to the staff. He offered to give more feedback to the Committee regarding their recommendatiores and on the status of various projects.
Discussion cf the Advisory Committee Process Larry Camper presented oa the Advisory Committee Process. This presentation covered much of the history of the Committee and how it has evolved over the last ten years. Also covered was the current recommendation process of the Committee and recommended improvements of the process. There was a discussion of the recommendation process and a feeling that more feedback to ACMUI from the staffis needed to keep the Committee updated as to how their recommendations are used.
In accordance with the ACMUI bylaws and recent direction from the Commission, the Committee is expected to formalize its recommendations, including dissenting opinions, within the minutes of each meeting. The minutes alog e ith the meeting transcripts are provided to the Commission.
ACMUI recommendations and concerns are considered by the staff and Commission in the development of regulations, guidance, and policy.
Dr. Flynn observed that the Commission seems to still be very reactor oriented. He suggested that there be one Commissioner who has a medical background. He also suggested that the NRC staff be expanded to include individuals with medical experience or the medical fellow program be expanded to make individuals with medical experience available to the current staff. Mr. Camper responded by describing contributions made by Dr. Polycove as a visiting medical fellow.
Dr. S!egel, an invited guest, noted that the bylaws state a member's term is two years, as opposed to three years which has been the practice. Mr. Camper responded that this was a good administrative point and that appropriate action will be taken to address the discrepancy.
Discussion of StafrRequirement Memorandum Regarding Direction Setting Initiative 7 Larry W. Camper discussed the Commission's Staff Requirements Memorandum (SRM) entitled
" Materials / Medical Oversight (DSI 7)" dated March 20,1997. He described the NRC staffs planned actions to complete the revision of Part 35 by the Commission's target date of June 30,1999.
Mr. Aubrey Godwin, an imited guest repre ing the States' perspective, remarked that tns SRM did not specifically address the "enforcen, ue." Mr. Camper responded that, although the SRM does not specifically address enforceu.. 4 DSI 7 does indicate that the effort toward risk-informed performance orientation should also be brought to bear in terms ofimplementation as it
3 relates to inspection and enforcement.
Mr. Godwin and Mr. Camper discussed the need to reduce the inspection frequency for low risk activities. They were in agreement that a reduction in regulatory presence would, in many cases, result in a reduction in inspection frequency.
Several members of the Conunittee expressed an interest in identifying the NRC 05cc that would lead the revision of Part 35. Mr. Camper explained that the lead for the Part 35 revision had recently been transfe:Ted to the N' ISS program office; and the Office of Nuclear Research will be q
providing resources and contract support. Dr. T :t questioned the difference she might see on a rule developed by the program omce compared to a rule developed by the Office of Research.
-)
Mr. Camper responded that, because the program office implements the rule for both licensing and inspection, and because he interacts directly with the ACMUI, it may be more sensitive to changes that are needed.
Mr. Camper proceeded to describe the plan for the staff revision of Part 35. This plan included submitting a program for the rulemaking to the Commission by June 6,1997 and have the final
)
revision of Part 35 by June 30,1999. Dr. Nelp asked ifNRC planned to revise each of the subsections of Part 35. Mr. Camper responded that we hue "a cle.m piece of paper " We have the opportunity to develop a completely new Part 35. However, if there are parts that do not need to be changed, the ACMUI should point them out. Mr. Camper proceeded to describe e possible model that had been provided to the program office. If this model were adopted, Part 35 would be organized by modality. Each subsection would contain all of the requirements for that particular use. This would enable the staff to easily make changes pertinent to a particular modality ofuse when needed.
Dr. Nelp stated that he believed the ACMUI could best be used in discussing "fooised" issues rather than organizational writing.
Dr. Stitt encouraged the Committee to give the NRC staff feedback on the issue of risk. Dr.
Williamson asked for definitions for risk-informed, and performance-based. Mr. Camper suggested the Committee begin with DSI 12, which defines the Commission interpretation.
Dr. Williamson asked, for the purpose of revising Part 35, what the term " performance-based criterion" means? According to Dr. Williamson, one of the major concerns of the regulated community he represents is enforcement resulting from " paper-work sorts of violations that have no clinical significance."
Mr. Camper responded that NRC will license, inspect, and enforce the written regulation. When the regulation changes, there will be a corresponding change in licensing and enforcement.
At this point, Dr. Stitt allowed Mark Rotman to read a statement prepared by the American College of Nuclear Physicians / Society ofNuclear Medicine which discussed risk and their support
4 of the IOM report.
Mr. Godwin, returning to the general topic of revising Part 35, pointed out that there was no apparent provision to take immediate action on current regulations that might be determined to be unneeded.
Ms. Walkup questioned whether the revised mie would be implemented in steps, or all at once.
Mr. Camper responded that they can be implemented either way. However, he would expect that there would be an effective date, and implementation dates for NRC and Agreement States licensees.
Dr. Barry Siegel, an invited guest representing the nuclear medicine perspective, made the statement: " diagnostic nuclear medicine is low-risk." He stated the belief that the revision of Part 35 should start with changes to NRC's Medical Policy Statement "so that the physician-patient interface is no longer the purview of the NRC."
Mr. Graham recalled the subject discussion, and moved forward to the Commitsion's directions to the staff for the revision. He reiterated the need to focus Part 35 on those procedures that pose the highest risk, and that the ACMUI further discuss the Medical Policy Statement, and how it would be modified to direct all ofits other activities. He suggested that the staff should consider oversight alternatives for low over-all risk activities; and regarding misadministrations the staff should only capture precursor events in the whole process of changing from " misadministration" to " medical event."
Dr. Swanson stated that, in discussions cf" risk," you must first define risk of what? He questioned what NRC was trying to regulate - public, occupational, or patient exposure? H $1so questioned the components of a risk matrix. He believed regulators would probably factor in political and public perception consequences. He also believed that medical use is low risk if you used NRC's probabilistic methodology.
Dr. Williamson suggested that, in discussing relative risk, the ACMUI should discuss three ferent populations that can experience consequences: the public, the workers, and the patients, and rank modalities separately. Depending upon how the issue of the Policy Statement is resolved, patients could be dropped. Dr. Stitt agreed with that approach.
Dr. Stitt called for a lunch break at 11:50 am.
Dinussion of the Medical Policy Statement of 1979 The importance of the Medical Policy Statement of 1979 to the entire process of revising the medical use regulations in 10 CFR Part 35 was brought out by Barry Siegel in the preceding discussion of DSI 7. Dr. Siegel believed the ACMUI had to start with the policy because it was 1
5 the driving force that set the boundaries on the Commission's regulatory oversight of medical use programs Extensive discussion followed.
Dr Siegel proposed dropping Statements 2 and 3 from the Medical Policy Statement (once the 2nd statement is dropped, the 3rd becomes irrelevant). This would remove the physician-patient interface from NRC's purview and have NRC focus its efforts on the workers and the general public. He recommended the ACMUI develop its recomm= Mons based on both the tract:
"without" and the track "with" patient safety u a part of NRC's medical regulations. Dr. Siegel pointed out that in the past the Commission's perspective was if one or several patients could be hurt because of the application of byproduct material then that risk to the patient justined the regulation.
Several members pointed out that the Medical Policy Statement did not need to be changed ifit was interpreted differently. Mr. Swanson stated that if a probabilistic risk assessment approach is used (the probability of risk times the potential outcome), for risky procedures with low g
probability the result is low risk.' Dr. Nelp believed that the policy did not need to be changed, all that was needed was for the ACMUI to determine that regulation of the patient radiation safety i
l was not necessary orjustified. Dr. Stitt proposed focusing on the phrase "where voluntary standards or compliance with these standards are inadequate." She pointed out that from 1979 to 1997 many adequate standards have been developed thus, the current policy statement could be used to support that there is no need for regulations.
Dr. Stitt also supported the idea that the Medical Policy Statement should be composed only of Statement 1 (NRC will continue to regulate the medical uses of radioisotopes as necessary to provide for the radiation safety of workers and the general public),
Others explaini their reasons for supporting Dr. Siegel's proposal. Dr. Wagner believed regulations addressing radiation safety of patients are not justified by the risk, since the probability of an' event occurring is extremely low, even if the once in-a-while incident has a high risk. He -
also thought as long as individuals have the proper training to handle radiopharmaceuticals, the risk is low. Dr. Williamson made the argument that although not substantiaily different from that of other medical subspecialties practicing procedures of similar intensity and complexity, the Medical Policy Statement allows NRC to impose an artificially low acceptance probability for misadventures upon the small discipline ofradiation medic'me. Dr. Flynn thought Statements 2 and 3 are covered by State licenses, which can be revoked by the State, and the patient was protected by various malpractice laws.
Ms. Brown did not agree with Dr. Siegel's proposal. She likes nuclear medicine's attention to detail and accountability, items that she believes may be lacking in the rest of medicine.-
A significant amount of time was spent discussing whether user training and experience requirements could still be imposed if Statements 2 and 3 were dropped. Dr. Siegel thought the training and experience requirements needed to protect the workers and general public would also
L 6
insure well trained physicians and indirect protection for the patient. Mr. Godwin believed if Statement 2 was omitted from the Medical Policy Statement all clinical experience requirements would be dropped and only minimal radiation safety training would be needed.
Mr. Swanson's indicated rather than t ying to argue for a new Medical Policy Statement, it may be better to ensure that the regulations reflect the Medical Policy Statement.
Dr. Nelp made the motion that Statements 2 and 3 be omitted from the Medical Folicy Statement.
The motion was seconded and opened for discussion. Both Mr. Swanson and Dr. Kang had reservations about the motion. Mr. Swanson's concem was that the NRC answers to the public,
- and it would be difEcult for the NRC to take out any statement that makes it appear that they are giving up regulatory authority over a risk issue. Dr. Kang agreed with Dr. Siegel's position that NP C should not interfere in medical practice, but was concemed that Statement 2 should be
- ch.nged and not dropped. He thought NRC has a particular duty with respect to reasonable assurances for the radiation safety of the public, including the patient.
After a lengthy discussion about whether the NRC could have training requirements without the 2nd and 3rd statements, and Mr. Graham's suggestion that Statement 2 be changed and not-dropped, the motion to delete Statements 2 and 3 from the Medical Policy act was withdrawn.
Dr. Siegel suggested two additional modifications to Mr. Graham's suggested change to Statement 2. The first was to have the beginning read "NRC will regulate the radiation safety of patients only wherejustified by the risk to patients, and only where voluntary standards or compliance with these standards are inadequate" and secondly to add ar.sther sentence at the end.
The second sentence was " Assessment of the risks justifying the regulations will reference comparable risks and comparable modes of regulation for other components of medical practice "
Dr. Siegel concluded that it defines the universe, and the reference framcyork. Mr. Graham suggested revisions to Statement 3.
Mr. Graham made a motion to revise Statements 2 and 3 of the Medical Policy Statement. Mr.
- Swanson suggested a minor change to Mr. Graham's recommendation. The ACMUI recommended by a 9 to 1 vote that Statements 2 and 3 of 1979 Medical Policy Statement be revised to read as follows:
l Statement 2: The NRC will regulate the radiation safety of patients only wherejustified by the risk to the patienta, and only where voluntary standards or compliance with these standards are inadequate. Assessment of the risks justifying such regulations will reference comparable risks and comparable modes of regulation for other types of medical practice.
Statement 3: The NRC will not intrude into medicaljudgements affect'mg patients and into other areas traditionally considered be a part of the practice of medicine.
The dissenting vote was cast by Ms. Brown. She indicated that the current Medical Policy
[
7 Statement is adequate and that no changes were needed.
Discuss Criteria and Ranking of Medical Procedures lavolvlag Byproduct Materials by Risk -
Cathy Haney led the discussion on the criteria and ranking of medical procedures by risk. Ms.
Haney asked ACMUI to discuss the following items: identification of key medalities and the relative risk; ranking of the modalities by their relative risks; identification of criteria to be used in the ranking; description of the level of regulatory presence needed for each modality; and identi6 cation of the key items to be regulated under each modality.
The Committee began with the first discussion item, identi6 cation of key modalities and the
- relative risk. Due to time constraints, the Committee did not address each item separately however, some of the discussion did touch upon related topics, such as, ranking the modalities by their relative risks.
The first issue discussed by the Committee was defining what was meant by risk, particularly in a medical context. It was generally agreed that overall risk for a given modality is defined by the product of the probability of occurrence of an error multiplied by the severity of the consequences of that error.
This was followed by a discussion on whether risks, for a given modality, to the patient, worker,-
and public should be treated separately or combined. To simplify the discussion, it was proposed -
that only risks to the patient be considered. However, after further discussion, it was generally agreed that most modalities presented some risk to all three populations. Thus, a determination of the overall risks associated with a given modality would need to consider all three populations.
The point was made that risks to the patient differed in one substantial way from those to the workers and public. Namely, the patient risks were single short time span events, whereas, the risks to the workers and the public tend to be cumulative over time.
p In order to better focus the Committee's discussion, it was recommended and agreed upon to -
begin by discussing the risks associated with diagnostic nuclear medicine. There was general agreement among the Committee that this was readily classified as a low risk modality with little risk to either the patient, worker, or the public. This classi6 cation was based on the Conmittee's perception that the risks associanxi with this modality had both a low probability of occurrence and that the non-stochastic consequences of an error were negligible. It was, however, pointed
- out that this was not the case for many diagnostic quantities ofI-131 due to the significant i
probability for damage to the thyroid from a misadministration or medical event. Also, l
recognized was the potential for injury to the workers and public from the use ofI-131.
The potential for patient harm from misadministrations ofI-131 led to a discussion of how a diagnostic procedure or isotope could be classified in terms of risk. While generally agreeing that most diagnostic procedures should be classified as low risk, it was recognized that not all could be
e-8 so clannin d. It was genwally agreed that the Committee wanted to avoid doing an isotope by e
- isotope evaluation of risks associated with diagnostic nuclear medicine procedures. This led the a proposal by the Committee to derme the risk associated with a given diagnostic nuclear medicine procedure as follows:
" Diagnostic isotopes should be classified as low risk unless there is the potential for observable clinical injury to the whole body or an individual organ".
Discuss the Regulatory Use ofIndustry Standards Susanne Woods led the discussion on the regulatory use ofindustry standards. She indicated that item 7 of that SRM directed staff to consider the viability ofusing or referencing available industry guidance and standards within Part 35 and related guidance to the extent that they may meet NRC's needs. The Committee was asked to discuss how to bring available industry guidance and standards into the regulatory framework, where they should be located, and how to keep the information current.
The Committee did not reach a consensus but actively explored a number of perspectives and issues associated with Item 7.
Dr Siegel thought the partial answer was in the medical policy statement already, i.e., NRC will make a regulation where voluntary standards or compliance with voluntary standards are
- inadequate. He believed that it was not necessary to reference standards in the regulations, but rather look to see if the standard of care is being defined by the existence of those voluntary i
standards; then decide whether or not there's general compliance with those voluntary standard.
If this was the case, he believed a regulation was not needed.
2 Mr. Graham pointed out that each standard has a potential to be handled differently. For -
example, the potential ANSI classification cf a sealed source that might be used in brachytherapy, might be put in the regulations as a minimum standard for the type of sealed source. On the other hand, AAnM guidance documents should be put in guidance so that the documents can be modified by an institution. He also pointed out a number of problems in using industry standards.
First, NRC will be lagging the industry practice as updates come outc Since an update has to be reevaluated and put in the Federal Register to give people a chance to comment on it before it is adopted. Secondly, users of standards may not be willing to adopt revised standards although NRC has endorsed the revision. The community then continues to follow a document that is no longer accepted by NRC. Dr. Siegel pointed out an additional problem in that industry standards, in substantial part, were predicated on existing NRC requirements. He stated a concern that if regulations did not exist, standards may not be developed. Dr. Flynn pointed out that some standards, while applicable to a medical use NRC regulates, really have very little to do with NRC.
Mr Swanson concluded that the Medical Policy Statement says NRC will regulate where l
1
9 compliance and standards are inadequate.- Ifinclusion in the regulatory gu dance does not constitute regulations, then by definition, NRC would have to put industry standards and guidance in the regulations. Others had concerns that documents meant to be flexible would become engraved in stone if they were incorporated in regulatory guides. Dr. Flynn recommended referencing the standards in regulatory guides an:t updating the guides annually, i
Dr Williamson conduded that simply saying standards of practice will be in the licensing guide for implementing a given regulation might not be appropriate. He indicated that it might be better to go through the various standards one by one and isolate the recommendations pertaining to the issue of direct concern Discussion of Quality Management and Misadministrations Sally Merchant requested that the ACMUI identify the incidents, events, and occurrences that should be reported to the NRC, Patient harm, including a dose to the wrong patient or wrong treatment site, and the following possible failures were provided as potential reports.
Mr. Swanson discussed his preference that medical events be reported to one organization, rather than establishing reporting levels. He believed that this organization need not be the NRC. He also provided the following positions. Diagnostic events should be captured to (1) provide more data and (2) identify poor therapeutic practices tht are likely to accompany poor diagnostic
- practices. The reporting environment should not be punitive, in order to encourage reporting foi the purpose of cause determination.
Dr Swanson cited the USP medication errors reporting program of voluntary and, possibly, anonymous reponng to FDA as an example of a reporting pro;; ram. Dr. Swanson further commented that the nuclear medicine community does not appear to be following this standard well, and, as such, the Medical Policy Statement would need te support initiating requirements to panicipate in the USP program A peer group would identify the need to examine a site identified for several events. Participation would be identified upon inspection.
Dr. Williamson agreed that all precursor events should be reported, including near misses and
- inegularities. He emphasized that few radiation oncology events are likely to result from machine failure. Dr. Nelp commented that diagnostic misadministration have a very low incidence. He believed that a tremendous amount of data would not be collected. He felt that the concept is punitive, and the determination has been made that there is no risk.
Mr. Graham indicated the need to explicitly define, at a national level, the cost-benefit for a national tracking system. He preferred that the reporting and analysis be kept within the health care system. He believed that the system is large enough to collect a large amount of data and small enough to analyze it, while changing the way care is delivered.
Dr. Kang commented that the FDA Center for Device Evaluation receives all machine failure
10 reports. Mr. Camper commented that NRC will need to avoid duplication ofFDA effons.
Mr. Godwin commented on several areas. He indicated that the listing provided by FDA is a.
data-base print-out with both time-line and organizational problems, and that an analysis is not provided to address generic failure, single event failure, or whether the community should be alerted. He also diamanut the need to add " wrong pharmaceutical" to the reponing listing provided by NRC, and the need to include listed items in hrt 21 requirements. He introduced the FAA pilot-reporting system as demonstrating a non-punitive approach to reporting.
Mr. Williamson suggested that the term " medical event" be reserved for events with a high probability of resulting in an adverse medical effect on the patient. This type of event should be distinguished from (1) " bookkeeping" errors, (2) treatment delivery errors without medical -
consequences, and (3) precursor events. Dr Stitt indicated that " medical event" appears to be a health care / patient related term.
Mr. Camper emphasized that the defmitions used are as imponant as the actual terms they define.
Events such as software failures, machine fsilures, and leaking sourca may be reported without calling them misadministration. He indicated that reporting levels need to be defined for those events that result in exposure to a patient. Dr. Nelp commented that the threshold would be high, ifbased on harm to the patient.
Mr. Williamson commented that a case-by-case review would have to be made to isolate events involving ratients with signi6 cant risk of being harmed snd establish reporting requirements. He referred to a de6nition of misadministration that he and Ms. Brown submitted to ASTRO and ACR, which established a threshold overdose of greater than 20 percent, when the entire course of therapy (i.e., external beam and radioisotope therapy) is included. The lower threshold for wrong site was at least 2 Gy to a site that was not planned to be in the treatment field, or 10 percent more than the dose that would have been delivered via the planned treatment, whichever
.was greater.
Mr. Swanson commented that the complexity of the current misadministration definition is a problem that is confusing when, in practice, it differs from state requirements for reporting events associated with accelerator-produced products.
The discussion was summarized by Mr. Graham as falling into two treas of thought: (1) a non-threatening system that collects as much data as possible for id_entification of system or process issues / patterns to be corrected; and (2) a system of reporting only those things that c'sarly represent probable damage to the patient.
- At this time the meeting ended and reconvened at 8:12 am Friday April 11,1997.
11 Status Report on Ruleanaking and Guidance Cathy Haney gave a status report on the following topics: patient release rule and guidance; NUREG-1569, Program SpeciSc Guidance for Medical Use Licenses; TI QM analysis; ANPR for Part 33; Carbon-14 petition for rulemaking; and a new petition from the University of Cincinnati.
Ms. Haney indicated that the patient release rule (10 CFR 35.75) becomes effective on 5/29/97, and that the associated Regulatory Guide would be available in about two weeks.
I She indicated that NUREG-1569 was due to be published in draft during the spring of 1997. This
' document was being issued for public comment and is not to be used in the preparatbn or revie v -
- of applications for medical use licenses.
She provided a brief summary of the public cor..ments received in response to the advanced notice of proposed rulemaking (ANPR) on Part 33. This presentation resulted in the ACMUI bringing the following motion to the table: "ACMUI recommends retention of the current regulatory approach for (Part) 33." The vote was 9 for and 1 opposed. Dr. Williamson stated in opposition that "[he does not] feel able to assess the rigidity and flexibility of the current process relative to -
what might happen at this time."
Ms. Haney indicated that revised inspection guidance on performing inspections of the quality management (QM) rule has been provided to the regional staff. She indicated that a summary of the QM inspection procedures was provided to ACMUIin the briefing book. The ACMUI dim!s=1 he nature of the QM inspection procedures and brought the following motion to the t
tablei "[the ACMUI recommends that the NRC] modify the QM 'mspection procedures with the intent to reflect the spirit of the Commission direction in the SRM [regarding DSI 7]." The vote was 9 for the motion and I abstention. : Judith Brown abstained because she was not familiar with all of the elements of the issue. Dr. Wagner wished to go on the record stating that the QM rule -
as a regulation was un_-
y.
Cathy Haney introduced the subject of the carbon-14 petition which was received in 1994. This
- prompted a discussion of the rulemaking process and the timeliness of the process. The -
rulemaking plan to resolve the petition will be forwarded to the EDO this month.
Ms. Haney informed the ACh"UI that the staff _was reviewing a petition submitted by the University of Cincinnati. Tais petition requested that the NRC amend 10 CFR 20.1301, " Dose limits to individual members of the public," to authorize "specified visitors" of hospitalized radiation therapy patiants, as individual members of the public, to receive 500 mern. per year.
Ms. Haney indicated that additional information on the resolution of this petition would be made available at the next n=ating of ACMUI.
12 Preperstles for the May a Comsalssion Briefing
- Ihe Committee members prepared for the Commission briefing on May 8 at 9 am. Dr Flynn suggested that the Committee spend only 15 minutes on the Medical Policy Statement and the remaining 45 minutes addressing the 8 items of the SRM regarding DS! 7.
Larry Camper requested that the Committee prepare their recommendt.tions on the revision to Part 35 and submit them to the staff before the May k Commission Briefing. The Committee indicated that they would use telephone conferences to discuss issues associstW with the revision of Part 35.
The meeting closed at 12:25 pm.
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UNITED STATES j
NUCLEAR REGULATORY COMMISSION
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June 4, 1997 MEMORANDUM T0:
Chairman Jackson Commissioner Rogers u ioner Dicus
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Commissioner Diaz Commissioner McGaffigan M
FROM:
L. Joseph Callan s pfations Executive Direct 6r r
SUBJECT:
MASTER MATERIALS LICEN5ES FOR NON FEDERAL LICENSEES A Staff Requirements Memorandum (SRM) dated September 18. 1996 (Attachment 1),
regarding SECY 96 167. " Specific Domestic Licenses of Broad Scope for Byproduct Material Advance Notice of Proposed Rulemaking" (ANPR), directed the staff to address.ht issus of whether 'lon Federal licensees may obtain master materials licenses (MML). While there is no express prohibition in the Atomic Energy Act against extendin the MML to private Entities there are important State / Federal legal and olicy implications, which must be considered in extending the MML.
pecifically, the role of the Agreement State in such a. licensing framework must be considered. Agreement States now have jurisdiction over the types of materials that would be covered by an MML for a private entity If we were to ma4ntain the existing division of authority between the U.S. Nuclear Regulatory Commission and the Agreement
. States, for the MML 3rogram for private entities, it could undercut the (ffectiveness of an iML.
For example, an NRC HML could only cover f stilities operated by the MML holder within NRC States (i e.. under NRC's jurisaiction). Conversely, an HML issued
'by an Agreement State could osly cover facilities in that State. The same limitations do not apply to Federal agencies with MMLs. because such entities are regulated by NRC regardless of their location. As described below, public coments in res>onse to the ^NPR allude to these issues. The staff will need to address whetler the current jurisdictional limitations would reduce the efficacy of issuing MMLs to private licensees, in addition, any changes to the current jurisdictional framework (i.e.. amendments to existing agreements) designed to accommodate the issuance of HMLs may be extremely difficult and, in some cases, legally unsound.
CONTACT:. Donna Beth Howe, NMSS/IMNS (301) 415 7848
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As a result of the SRM. the following associated question was added to the ANPR for Title 10 of the Code of Federal Reoulations. Part 33 (10 CFR Part 33)
(61 Federal Reaister 58346):
Question 9. "$hould a Category for ' Master Materials Licenses' be incorporated into Part 33 with respective necessary requirements?" The 11 commenters responding to this question had mixed views:
2 supported incorporation in Part 33: 7 opposed: 1. an Agreement State, really had no comment if the master materials licensees remained restricted to Federal entities: and 1 asked questions. A number addressed the fundamental issue of Federal vs. State jurisdiction over ais-type of license.
The-coments are summarized in Attachment 2.
The staff will address resolution o' thase master materials licensing issues as part of the Part 33 rulemaking af'. cs.
Attachments: As stated cc: SECY OGC OCA OPA OSP 5
DISTRIB!ITl0N:
EDO 9600145/NMSS 9600351 IMAB r/f Hes. Thompson NRC File Center NMSS r/f JCallan ED0 r/f CPoland NMSS Dir. Off. r/f MBridgers HThompson
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l Septetaber 2$,1997 MEMORANDUM TO.
Those on the Attached List FROM:
Donald A Cool, Director (orig, signed by)
Division of Industrial and Medical Nuclear Safety, NMSS
SUBJECT:
POLICY AND GUIDANCE DIRECTIVE PG 6-02, REVISION 1 STANDARD REVIEW PLAN (SRP) FOR LICENSE A PPLICATION FOR MASTER MATERIAL LICENSE -
This memorandum transmits Policy and Guidanco C tractive (P&GD) PG 6-02, Revision 1:
- Standard Review Plan (SRP) for License Application for f%.ter Material License
- dated September 25,1997 (attached). The SRP sets forth current policy on all of the major elements of the guidance provided in the original P&GD dated August 2,1996. Revision 1 supersedes PG 6-02 in its entirety and the Regions are to begin using this revised guidance.
The SRP was developed and reviewed by staff and management teams consisting of Regional and Headquarters personnel. This process followed guidelines established during the business l
process redevelopment effort for material licensing.
Attachment:
PG 6 02, Rev.1 CONTACT: John D. Jones, Rlli (630)829 9832 DISTRIBUTION:
FCostello, RI TDecker, Ril RCaniano, Rlli MPhillips, Rlli JMadera, Rill CCain. RIV BSpitzberg, RIV FWenslawski, RIV DHowe NRC Central File IMOB r/f IMAB t/f IMNS r/f NMSS r/f NMSS Dir Off rit DOCUMENT NAMEf A:\\PG96 02.WPD To receive a copy of this document. Indicate in the box: "C" = Copy without attachment / enclosure
- E* = Copy with ettcchment/ enclosure
- N* = No copy f
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i United States Nuclear Regulatory Corninission i
l Policy and Guidance Directive PG 6 02 Revision 1 f
I STANDARD REVIEW PLAN (SRP) FOR LICENSE APPLICATION FOR MASTER MATERIALS LICENSE l
i Division of industrial and Medical Nuclear Safety Office of Nuclear Material Sqfety and Sqfeguants i
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1 TABLE OF CONTENTS O
1.0 Ep.rggas........................
.......... 1 1.1
_ Definition and Desenotion...........................
.1 1.2 lasuarge Criteria for a Master Materials License.
...........,....,.1 1.3 Master Materials Licensee Authonzations............................ 2 1.4 Prelicensina Conference...................,.................... 3 1.5 Pronrams Not Warrantine a Master Materials License................... 3 2.0 Review of a Master Materials License Anolica' ion
..............3 2.1 Letter of understandina....................................... 3 2.2 Licensina rnd Enforcement HistoIy.............................. 4 3.0 FILING AN APPLICATION............
....................... 5 4.0 CONTENTS OF AN APPLICATION................................... 5 I'
4.1 NRC Form 313 Item it License Information.
.6 4.2 NRC Form 313. Item 2: Anolicant's Name and Mailina Address........... 6 4.3 NRC Form 313. Item 3: Location of Use
........................... 6 4.4 NRC Form 313. Item 4: Person To Be Contacted About Aoolication...... 6 4.5.
NRC Form 313. Item 5: Material To Be Possessed..,..,..,........., 6 4.6 NRC Form 313. Item 6: Pumose of Use of Licensed Material..........,.. 7 4.7 NRC Form 313. Item 7 Individn=la Resoonsible for the Radiation Safety Prooram
.......,.................................................8 4.7.1 Serlor Management................................... 8 4.7.2 Master Radiation Safety Committee...................,
9 4.7.3 Radiation Control Program Director.................... 10 4.7.4 Other R C P Staff..............................,...... 11 4.8 NRC Form 313. Item 8. Trainina and E_xnenence for Individuals Workino in or Frecuentina Restricted Areas,...............,......,,,....... 11 4.9
' NRC Form 313. Item 9. Facilities and Eauioment........,...,...,.... 12 4.10 NRC Form 313. Item 10. Radiation Safety Proan *}.....,..,.......... 12
'4.10.1 Previous Licenses.................................. 12 L
4.10.2 Regulatory Conformance
............................. 13
'4.10.3 Updating of RCP Documents
......,................... 13 4.10.4 Management Oversight and Radiation Control Program Procedures
................. 13 4.10.5 Master Radiatien Safety Committee
..... 14 4.10.6 The Radiation Control Program Director....
15 4.10.7 Permitting and Inspection Staff...,....,............... 16 4.10.8 R C P Proced ure s..................................... 17 4.10.9 Management and Master Radiation Safety Committee Audits... 17 4.10.10 PermP. ting Procedures..............,.,....,,
18 4.10.11 Permitee Minimization of Contamination Program...........
19 4.10.12 Permit Termination and Decommissioning of Permit Activities... 19 4.10.13 Financial Assurance...
.. 19 PG 6-02, Rev.1 1
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4.10.14 Inspection and Enforcement Procedures 19 4.10.15 incident / Emergency Response Procedures 20 l
4.10.16 Procedures for Handling Allegations...
. 22 4.11 NRC Form 313. ITEM 11 WASTE MANAGEMENT.
22 4.12 NRC Form 313. Item 12. License Fees
.23 5.0 AMENDMENTS TO A LICENSE.............
.23 PG 6-02, Rev.1 ii 09/25/97
STANDARD REVIEW PLAN (SRP) FOR LICENSE APPLICATION FOR MASTER MATERIALS LICENSE
1.0 Purpose
This standard review plan provides guidance to be used by applicants preparing Master Materials License (MML) applications, and for, NRC's review of MML applications. NRC regional license reviewers will perform the initial review to ensure completeness of the application prior to submittal via technical assistance request for final review by headquarters.
Because the existing organization's licenses may be located in multiple regions, there should be close regionalinspection and licensing staff communication when evaluating new applications.
The NRC will review the applicant's regulatory philosophy and commitment to follow NRC requirements and criteria as evidenced by the license application, inspection history of the organization's individuallicenses, financial status and stability, clerical and professiontJ staffing of the proposed inspection and permitting program, independence of the MML governing body, and commitment to the MML. One or more prelicensing visits should be conducteo prior to issuance of any new MML.
1.1 Definition and Descriotion:
A MML is a multisite material (byproduct, source, and/or special nuclear material) license. The MML authorizes the licensee to issue permits for the possession and use of licensed material under the license, and ties the licensee to a framework for oversight and internal licensee inspection of the MML.
The MML licensee issues permits and conducts inspections of its permittees. The licensee must have a system for tracking permitting and inspection actions. The MML licensee's inspectors and permit revie vers must meet the same training requirements (Inspection Manual Chapter (IMC) 1246, "Forr. al Qualification Programs in the Nuclear Material Safety and Safeguards Program Area /' and use the same licensing and inspection guidance (IMC 2800, and IMC 2600 (" Materials inspection Program,") as their NRC counterpaits. MML licensees are inspected annually by the NRC to review the management, inspection, permitting, and enforcement activities performed under the license (IMC 2810, " Master Materials License Inspection Program.")
1.2 lasuance Cnteria for a Master Materials License A Master Materials License (MML) will be issued only to federal organizations which have:
Fngaged in a centralized control of activities involving the use of byproduct materials under specific icenses of broad and limited scope. Normally an applicant shoulci have had a centrally coordinated program for at least a 5 year period. (While recognizing the applicant does not have a master materials program at the time of applicatien, the NRC will evaluate the applicant's past centralized program with respect to fundamental elements needed to form the foundation of a mater materials program.)
An acceptable regulatory performance record, based on NRC licensing and inspection of prior activities for the last 5 years. (NRC will compare the applicant's existing PG 6-02, Rev.1 1
09/25/97
licensees' performance record with that of other similar licensees for the same time period.)
A radioactive materials utilization program of such scope for the last 5 years that the organization requires a variety of licenses and radionuclides, and the operational flexibility to cover numerous uses, users, and locations typically in multiple NRC regions.
Either proposed or existing centralized radiation control program, centralized administrative structure and organization, staff, facilities, equipment, and procedures adequate to provide protection of the health and safety of workers and the public against radiation hazards from the materials and uses over which the licensee proposes to assume responsibility for permitting and inspecting. (NRC will compare these elements with similar elements for existing MML licensees.)
Successfully met the enteria in 10 CFR 30.33.
1.3 Master Materials Licensee Authonzations Master materials licensees may permit any byproduct material authorized in the MML or by regulation to be used by components of their organization. The applicant may also request authorization to issue permits for the possession and use of specifically licensed quantities of source and special nuclear material. The MML licensee, through its master radiation safety committee (MRSC), may issue permits for the possession and use of licensed materials in accordance with NRC regulations and licensee permit review and approval procedures and enteria established by the MML licensee's MRSC. The MRSC permitting criteria must be consistent with NRC regulations and licensing policies, procedures, and guides. The MML must also establish an inspection program which is consistent with NRC regulations and inspection and enforcement policies, procedures and guides.
The Letter of Understanding (LOU) for a MML may contain exclusiens which provide that unless specifically authonzed, a MML may not conduct certain activities. Typically, the exclusions stated in a LOU provide that, unless specifically authorized, persons licensed under MMLs shall not:
grant exemptions to NhC regulations, conduct tracer studies in the environment involving the direct release of radioactive e
material (field uses);
conduct activities authonzed under 10 CFR Part 32 (manufacture or distribution of items to persons exempt from licensing, items to general licensees and radioactive drugs fer medical distribution, sealed sources and medical devices containing sealed sources for medical distribution), l') CFR Part 34 (radiography),10 CFR Part 35 (medical use),10 CFR Part 36 (irradiators) 10 CFR Part 39 (well loggina);
conduct activities requirir,g a specific license pursuant to 10 CFR Parts 40 and 70; or PG 6-02, Rev.1 2
09/25/97
l.
add or cause the addition of byproduct materihl to any food or other product designated
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for ingestion or inhalation by, or application to, a human being unless specifically authorized (i.e., medical use).
1.4 Etelicensina Confererme After an application for a MML has been reviewed by the NRC staff and found to be generally complete and responsive to NRC Form 313 and this standard review pian, one or more prelicensing visits will be scheduled by the NRC at the MML applicant's radiation control program central office. The prelicensing visits will include a conference with the applicants senior management and proposed MRSC members.
A prelicensing visit provides the NRC staff an opportunity to better evaluate the applicant's proposed program and the necessity for a MML. It also provides the NRC staff an opportunity to meet with the applicant's senior management, proposed MRSC members, and others responsible for the centralized radiation control program, stress the importance of the applicant's responsibilities under a MML, and to discuss and igree on additionalinformation and commitments that may be needed in a LOU as well as an opportunity to review implementing details.
1.5 Procrams Not Warrantina a Mastgr_ Materials License If the NRC determines that the issuance of a MML is not warranted, the applicant may continue wi)its existing licensed activities and may submit an application for a MML at a later date without prejudice.
2.0 Review of a Master Materials License Annlication An application for a Master Materials License (MML) (i.e. NRC form 313 and attachments) will be reviewed at the Region for completeness. Upon completion of the evaluation of the application, the application and reviewer comments will be forwaroed to NRC Headquarters via a technical assistance request for review and coordination of the application. MML applications will be reviewed by a team of headquarters and regional staff experienced in licensing and inspection procedures. The team willinclude at least one project manager from an existing MML. The team leader of the review team will typically be from the region in which the MML will be based if issued.
2.1 Letter of Understandino Where responsibilities are divided between the MML management and NRC, division of responsibilities and requiretaents for coordination must be clearly defined and documented in a LOU between the NRC and the applicant for the MML. The following are some examples of responsibilities that may be divided:
investigations of allegations;
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enforcement activities;
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4 permit termination and decommissioning; use of byproduct material for v.hich the NRC has not published any specific reguistions, e
policies, or guidance; or waste incineistion in accordance with 10 CFR 20.2002.
The following are some examples of responsibilities which will not be shared for which the licensee must continue to; report to and notify NRC in accordance witn regulatory requirements; request authorization for exemptions to the regulations submit environmental assessment report pursuant to 10 CFR Part 51; or e
submit decommissioning financial at.,tance in accordance with 10 CFR 30.35 e
submit an emergency contingency plan for possession of licensed materials pursuant to 10 CFR 30.32(l)(1).
2.2 Licensina and Enforcement Historv A MML will be issued only to organizations which have a good regulatory performance record, based on NRC licensing and inspection of prior activities. The NRC will review the applicant's performance for the last five y'..ars. As a minimum, NRC will use the following indicators to perform this evaluation:
Demonstrated proficiency at completing license applications.
Timely and effective communications within the organiz. tion at all levels regarding radiation safety program issues, Self identification and correction of generic salaty issues and regulatory compliance.
e Existence of cases brought to NRC's attention in which employee radiation safety concerns were not adequately addressed by the applicant.
Number of inspections that resulted in:
(a) no cited violations, (b) violations cited in a notice of violation, and (c) violations considered for escalated enforcement.
NRC findings with significant programmatic implications.
Number of escalated enforcement cases that involved management oversight issues.
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Number and nature of recurrent violations.
Number of escalated enforcement cases that involved repeat violations.
Timely, comprehensive, and effective response to violations.
3.0 FILING AN APPLICATION The applicant must apply for a MML by completing NRC Form 313 (see Appendix A). Items 1 through 4,12, and 13 may be completed on the form itself and items 5 through 11 on supplementary pages. Identify and key each separate sheet or document submitted with the application to the item number on the application to which it refers. All typed pages, sketches, and, if possible, drawings should be on 8-1/2 x 11 inch paper to facilitate handling and review.
If larger drawings are necessary, fold them to 81/2 x 11 inches.
Allitems in the application are to be completed in enough detail for NRC to determine that the proposed equipment, facilities, training and experience, and radiation control program satisfy regulatory enteria and are adequate to protect health and minimize danger to life, property, and the environment.
License applications are available for review by the general public in the NRC Public Document Rooms; therefore, do not submit propnetary information unless absolutely necessary, if submittal of such information is necessary, follow the procedure in 10 CFR 2.790. Failure to follow this procedure may result in disclosure of proprietary information to the public or substantial delays in orocessing the application. Do not submit personalinformation about individual employees unless necessary. Home addresses and telephone numbers should be submitted only if they are part of an emergency response plan. Dates of birth, social security numbers, and radiation dose information should be submitted only if specifically requested by the NRC.
The applicant must file the application in duplicate and retain a third copy for its licensing files.
Federal agencies may apply for r. MML for use of licensed activities anywhere in U.S.
jurisdiction.
4.0 CONTENTS OF AN APPLICATION The following comments apply to the indicated items of NRC Form 313:
Note: Throughout this document, Iterns which are descriptive and demonstrative which will not be incorporated into the license as a requirement is iHicated by a single Asterisk (*).
Applicants for a MML should clearly identify in the ay.ication that information which will be legally required (tie down) and distinguish it from that information which is descriptive and demonstrative which will not be incorporated into the license as a requirement.
NRC will check whether the application has been signed by the certifying official (Item 13) and will return the application if not so signed.
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4.1 NRC Form 313 Item 1: License information For a new license, check subitem A. For an amendment to an existing license, check subitem B. Since MML's have an indefinite expiration date, they are not renewed and subitem C should ahways be blank.
4.2 NRC Form 313. Item 2: Anoticant's Name and Mailina Address Applicants should be Federal entities. Therefore, corporations and private individuals may not apply for a MML. The address specified here should be the mailing address for official correspondence. This may be either the address of the Chairman of the Master Radiation Safety Committee (MRSC) or the Radiation Control Program Director (RPCD). Since a MML has an indefinite license period the applicant should be particularly sensitive to subsequent changes in its mailing address 4.3 NRC Form 313. Item 3' Location of Use, Specify the proposed location of the MML applicant's Radiation Control Program (RCP) Office by the street address, city, and State or other descriptive address (e.g.,5 miles east on Highway 10, Any town, State). This should be the location of the docketed permittee files for the master materials licensee or where they can be readily retrieved for review. The licensee should maintain a list of locations by program code identical to the one used by the NRC and provide an updated list to the NRC.
Applicants must indicate if they will authorize permittees to use radioactive material at temporary job sites, if permittees will use radioactive materialin field studies, these activities must be specifically identified and authorized on the MML. Appendix B contains information required for field use of licensed material, i.e., P & GD 84 20. NRC will follow the guidance provided in Appendix C and P & GD 84 20 when evaluating such requests.
4.4 NRC Form 313. Item 4: Derson To Be Contacted About Anolication The applicant must specify the individual that will be the RCPD and provide his or her telephone number.
4.5 NRC Form 313. Item 5: Material To Be Possessed While the major authori7ation in the MML will specify any byproduct material in any form and as needed or limited to s';me maximum quantity, there may be specific additional line items for some radionuclides. Thorefore, the applicant should desenbe, in general, the licensed material the applicant wishes to possess by isotope class (e.g., byproduct, source, or special nuclear material), chemical or physical form, and quantity in curie, millicurie, etc. This possession request should be categorized into general areas of use, e.g., research and development activities, routine gauging activities, self contained irradiators, instrument calibrators, anu medical applications. If certain nuclides will be needed in much larger quantities than others,
. PG 6 02, Rev.1 6
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they should be listed separately in items Sa,5b, and Se of NRC Form 313. rather than including these under the broad authorization for that class of licensed material (e.g., any byproduct material). Large activity sealed sources used in devices (e g. self contained irradiators, panoramic irradiators, instrument calibrators) that are not registered in accordance with 10 CFR 32 210 should be described by manufacturer and mociel number under item Sb.
The maximum quantity for each individual nuclide and total cumulative possession authorized by the MML licensee for individual permitteen should be commensurate with each permittees needs, facilities, procedures, and personnel and demonstrated experiece/ capability. The applicani should desenbe facilities or permittees which may possess quantities of those materials requiring financial assurance in accordance with the requirements of 10 CFR 30.35 or requiring consideration of the need for an emergency plan for responding to a release in accordance with 10 CFR 30.32.
MML applicants should develop and maintain a strong inventory and accountability system.
The applicant must also establish procedurt s for proper transfer, control, and accounting for movement of material between facilities. NUREG 1551 provides additional usefulinformation on control and accountability. An applicants inventory and control system must have the capability to ensure that licensed possession limits are not exceeded and that material is accounted for throughout the applicants organization. Sufficient staff and equipment should be devoted to the inventory and accountability control program. The applicant must describe its procedures for inventory control and accountability of licensed material.*
4.6 NRC Form 313. Item 6 Puroose of Use t,f Licensed MateDal The applicant should describe in general terms the purposes for which it will use licensed material and explain why a MML is needed. The uses should be consistent with the applicant's prior licensed activities and categorized in a classification scheme according to the NRC's licensing program codes. The information provided regarding " Purpose of Use"is understood by the NRC staff as a self imposed limitation contained within the application. If a master matenals license applicant desires to initiate an intended use other than that described in its application and tied down in its license and letter of understanding, it would be necessary to submit an amendment request to the license t.
tfy/ expand the " purpose of use".
Applicants should include a list of total possession i:mits for each category of use requested.
NOTE:
If the newly added purpose of use includes material use in unique or specialized activity (e g. sealed source fabrication), the applicant may be required to submit the entena used by the MRSC in evaluating in-house requests for such use.
Regulatory Guide 10,10 " Guide for the Preparation of Applications For Radiation Safety Evaluation and Registration of Devices Containing Byproduct Material" and 10.11 " Guide for the Preparation of Applications for Radiation Safety Evaluation and Registration of Sealed Sources Containing Byproduct Material" provide guidance for the evaluation and registration of sealed sources and devices with the NRC. Policy and Guidance Directive 84 22, Rev.1, "What Source and Device Designs require an Evaluation" may also be helpful.
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State if you intend to use sealed sources other than those that have been registered with the NRC's Sealed Source and Device %g stry and describe the training and experience of individuals responsible fo reviewing applications for use.
If the applicant has a permittee that desires to perform field studies in which licensed material is deliberately released to the 6nvironment for study purposes, then the information outlined in Appendix E of Regulatory Guide 10.5, Second Proposed Rev. 2 (DG-0005) " Applications for Licenses of Broadscope," must be included with the application and such field studies specifically authorized in the MML.10 CFR 51.22(c)(14)(v) identifies as a " categorical exclusion" (from the requirement to prepare an environmental assessment or impact statement) the issuance, amendment, or renewal of licenses for use of radioactive material for research and development and for educational purposes. However, this "categoncal exclusion" does not encompass, among other things, performance of field studies in which licensed material is deliberately released directly into the environment for purposes of the study, (e.g.
tagging of animals or insects which remain in the wild). Field studies may require an environmental report filed by the applicant and an environmental assessment by NRC pursuant to 10 CFR Part 51. Field studies that do not deliberately release radioactive material into the environment, such as tagging of animals and penning them to prevent escape, may be eligible for a " categorical exclusion" pursuant to 10 CFR 51.22.
Provide sufficient information about these studies for NRC to determine whether a categorical exclusion is appropriate.
4.7
_NRC Form 313. Item 7 Individuals Resoonsible for the Radiation Safety Proaram 4.7.1 Senior Management A MML is issued by the NRC to accommodate those licensees involved in extensive radioactive materials programs where the demand is great for a variety of radionuclides, uses, and locations of use across NRC regional boundaries. Therefore, the NRC grants significant authority to MML licensee management to develop and implement an appropriate radiation control program, Consequently, it is essential that strong management controls and oversight exist to ensure that permitted activities are conducted properly. MML licensee management must establish administrative controls and provisions relating to organization cnd management, including management review, necessary to assure safe operations.
Management responsibility is often underemphasized in applications and often poorly understood by licensee employees and managers. MML licensees are required to establish a MRSC that represents management when reviewing and approving permit applications.
Therefore, senior executive management (highest level of licensee management) should delegate to the MRSC and the RCPD, in writing, sufficient authority, organizational freedom, and management prerogative, to communicate with and direct MML personnel at all levels regarding NRC regulations, MML license provisions and permit conditions. The MML licensee retains the ultimate responsibility for the conduct of licensed activities. It is also essential that the MML licensee devote sufficient financial resources (i.e., funds, equipment, personnel, materials) as necessary to support the radiation control program at all levelsc PG 6-02, Rev.1 8
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4 4
The applicant should describe senior executive management oversight and processes used by senior executive management to ensure adequate control over MML licensed activities. The NRC expects senior executive management oversight to include senior management membership and active perticipation in regular meetings of the MRSC, as well as oversight of the RCPD and support staff, and annual audits of the program to assure safe operations and compliance with regulatory requirements.
The application should include an organizational chart depicting the applicant's management structure, reporting paths and flow of authority, including a statement empowering the MRSC by outlining its authority to oversee the licensed program and responsibility for control and direction of the radiation control program and the RCPD and empowering the MRSC to suspend or terminate activities based on poor performance or violation of safety standards.
These issues are addressed further in Section 4.10.
4.7.2 Master Radiation Safety Committee The MRSC serves as a window to the licensed program through which management gains an overall picture of MML activities, and the respective roles of the RCPD, MRSC, and other responsible individuals, including permittee activities. The MRSC functions to provide guidance and information on the radiation control program to senior executive management, ensure that adequate resources are provided by licensee management, and provide oversight to the RCPD l
in the developtrient, implementation, and maintenance of the radiation control program. The MRSC should ensure that executive managem". t is periodically given all relevant information regarding the radiation control program, particuiarly when management will make decisions that may affect the program.
The Chairperson of the Committee should be empowered at a minimum; to r,et the agenca, l
direct committee meetings, determine the existence of a quomm. verify the minutes, summarize the committee's position regarding decisions, sign all official documents of the committee, appoint a temporary replacement chairperson (not the executive secretary) in the event of his/her required absence, and vote.
The Executive Secretary of the MRSC, which is an assigned duty of the RCPD; serves as a liaison between the MRSC and the RCP staff, informs the Chairperson of staff commitme, ts and resources, assists the Chairperson in preparing the agenda, advises the committee of current regulations, and proposed changes in NRC regulations and policies, and provides the committee with quarterly reports on the status of the program, in addition, the Executive Secretary should prepare an annual audit report including overall conduct, result of the program performance compared to regulatory requirements and commitments, review of permitting actions, inspection reports, and enforcement actions.
Memt'ership of the MRSC must include:
a senior manager from the applicants executive management organization to serve as the Chairman PG 6-02, Rev.1 9
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managers capable of establishing RCP policies. These managers should be drawn from major division, department or organizational elements that represent the permittee community the RCPD who serves as the Executive Secretary of the MRSC a manager from the applicant's finance organization e
Other Members:
managers responsible for establishing and implementing major program activities under MML managers that represent permitting and inspecting organization e
representatives of occupationally exposed workers The applicant must:
identify the Chairman of the MRSC and provide assurance of the chairman's full authonty to commit licensee resources to support the conduct of the MML.
identify other individual members of the MRSC by position title and job description desenbe how the applicant ensures that each MRSC member has adequate education, training, experience and knowledge to adequately address radiation control program issues 4.7.3 Radiation Control Program Director The RCPD should ensure that radiation safety activities are being performed according to approved policies and procedures, and that all regulatory requirements are complied with in the daily operation of the licensed program. The RCPD implements the radiation control program with the assistance and support of the MRSC and senior executive management and serves as the Executive Secretary of the, MRSC. The RCPD's position as Executive Secretary of the MRSC, helps to insure clear understanding of mission goals and precise communications between the MRSC and the RCP staff.
Executive management is obligated to select a RCPD who has sufficient training and experience to address all facets of the applicants iadiation control program. The RCPD should have an academic degree in physical or biological science or engineering, spec;fic training in radiation health sciences, and considerable professional experience (generally a minimum of 5 years) with a broad spectrum of radioactive materials, Generally, a RCPD at a MML should have experient.e managing a radiation safety program where a broad spectrum of isotopes were used and licensed activities were conducted. The RCPD must have management abilities such as developing and administering a budget, supervising a staff, being familiar with human resource matters, and having good wnting and oral communication skills. It is essential for the PG 6-02, Rev.1 10 09/25/97
. ~. -
4 RCPD to have a thorough knowledge of NRC regulatory requirements.
The applicant must provide generically the minimum qualifications of the RCPD. The specific individual designated RCPD and his/her qualifications should be included as demonstration information.'
identify the individual designated as the RCPD'
+
provide edscation, training and experience documentation that demonstrates the individualis qualified to manage the RCP 4.7.4 Other RCP Staff The RCP professional staff must have a sufficient education, training, and experience in the physical and/or life sciences. Education should include a bachelor's degree, or equivalent training and experience, and at least 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> training in the safe handling of radioactive materials, and in the characteristics of ionizing radis3on, units of radiation dose and quantities, radiation detection instrumentation, and biological hazards of exposure to radiation appropriate to the type and forms of byproduct to be used. Additional training must be commensurate with the types of hazards and technology to be permitted. Wntten job descriptions should be prepared so that professional qualifications needed to fill vacancies can be readily identified.
Staff members whose primary duties include reviewing / issuing permits or conducting inspections are to be appropriately qualified. NRC Inspection Manual Chapter (IMC 1246) provides guidance for such qualifications.
The applicant must:* -
provide a list of the RCP office staff positions by job title, description, and number of individuals for each position desenbe its procedures and criteria for ensuring that members of the RCP office staff are adequately qualified.
4.8 NRC Form 313. Item 8. i rainina and Exoerience for Individuals Workina in or Freauentina Restricted Areas T he Applicant must provide assurance if it posseta special facilities such as large irradiators, lodination facilities, HDR facilities etc. that it will provide site eccess training prior to assigning individuals to working in or frequenting restricted areas in accordance with requirements of 10 CFR Part *,0.
Identify any specbl facilities requiring site access training.
Describe training and experience required of individuals who will be required to work in, inspect, or frequent any restricted areas included under the MML PG 6-02, Rev.1 11 09/25/97
4 i
4.9 NRC Form 313. Item 9. Facilities and Eauioment Facilities and equipment used by the RCP staff to facil tate the day to-day operations must be i
desenbed.
The applicant must:
Provide a description and location of all facilities used by the RCP staff to carry out its activities, State in the application where the master or central permittee files and all other docketed and required files and records will be maintained.
Provide a listing and describe the uses of laboratory equipment such as counting systems, portable survey equipment, air monitoring or other devices necessary for conducting the inspection of permittees.
4.10 NRC Form 313. Item 10. Radiation Safety Program The MML program used to manage the nermitting and innpection of licensed activities is called the radiation control program (RCP).
. ensure safe operations under the license, applicants for MMLs must have estabkshed admir,.strative controls and provisions related to: organization and management, procedwes, record keeping, material control and accounting, and management review.
The licensee should commit to implement licensing and inspection programs in accordance with NRC enteria or submit any alternative procedures. If NRC guidance is used, the applicant must provide procedures to ensure that the program is updated as NRC guidance is changed, and that staff is trained in current NRC guidance.
If attemative procedures are adopted, The RCP description should be in narrative form and include the elem ents identified below. The requirement to develop, document, and implement a radiation protection program commensurate with the scope of the license request is contained in 10 CFR 20.1101; record keeping requirements related to the program are in 10 CFR 20.2102. These requirements apply to a RCP and at a minimum, should address program authorities and responsibilities, communications, quality control surveillance, program audits, procurement, staff selection and quahfication, information dissemination, document control and
.etrieval, etc.
In addition, wntten administrative control procedures should be submitted.' These procedures should be sufficient in detail, clanty and specificity to describe how management oversight for program activities will be carried out.
4.10.1 Previous Licenses
- List the radioactive materials licenses for which this application requests to be included in the MML.
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4.10,2 Regulatory Conformance The MML applicant's management must clearly indicate that the applicant will follow NRC regulations. The applicant may use operational controllevels that are more restnctive than NRC regulations; however, at a minimum the applicant's requirements must be as restrictive as NRC's regulations.
The MML applicant must submit cil policies, procedures, directives and guides the applicant has developed and will use to rnanage its RCP pursuant to NRC regulations, policies and guides. The applicant must specifically identify those NRC policies, procedures and guides which the applicant will adopt in their entirety in its RCP. These documents will be incorporated into the MML in a license condition.
4.10.3 Updating of RCP Documents The RCP must have established procedures for appropriate and timely updating of MML internal guidelines and requirements to ensure conformance with revisions to NRC regulations, policies and guidance. The applicant should confirm that any updates of these documents which involve a material change in the MML licensee's policies and procedures from the original commitments which were submitted in lieu of NRC criteria will be submitted to the NRC as part of a license amendment request.
4.10.4 Management Oversight and Radiation Control Program Procedures A MML licensee authorizes the receipt, possession, distribution, use, transportation, transfer and disposal of NRC regulated radioactive material (e.g., byproduct, source and special nuclear material) at permittee locations. The MRSC provides administrative control of all NRC licensed radioactive material used by the licensee and its permittees. The applicant must demonstrate 16 Jt it is financially and technically qualified to effectively conduct a MML program.
Operating funds must be sufficient to support program needs such as financial assurance for decommissioning, staff travel necessary to conduct an effective permitting compliance program, (including pre permitting site visits, routine inspections, fo!!ow-up or special inspections, and responses to incidents and other emergencies), instrumentation and other equipment to support the RCP, administrative costs, laboratory costs, laboratory service, computer and/or word processing support, preparation of correspondence, and office equipment, as appropriate.
The RCP must be supported with sufficient staffing and technical expertise and be located in the MML organization parallel with other comparable health and safety programs. The applicant's overall radiation management structure must provide assurance that the RCPD has access to the highest levels of MML management and some measure of financial and administrative control over permitting and inspection personnel.
The RCP must be orgarnd wdh the vit i' toward achieving an acceptable degree of staff efficiency. The licensee t '. aid place appropriate emphasis on major program functions, and provide specific lines of supervision from program management for the execution of program policy. The lines of communication and adninistrative control between the users and the central PG 6-02, Rev.1 13 09/25/97
4 office (RCPD) must be clearly drawn to provide authonty over the staff and uniformity in inspection policy, procedures, and supervision.
The applicant should develop and implement wntten administrative control processes.' These processes should be sufficient in detail, clarity, and specificity to demonstrate that the applicant's management will adequately oversee program activities. As a minimum, they should address program authorities and responsibilities, communications, quality control surveillance, program audits, procurement, staff selection and qualification, information dissemination, document control and retrieval, and other program elements that are essential to the successfulimplementation of the RCP.
The application must include an organizational chart depicting the licensee's management structure, reporting paths, flow of authority and control of finances, and geographicallocation of all management and staff components of the RCP.
4,10.5 Master Radiation Safety Committee Responsibilities of the MRSC include, but are not limited to:
establishing procedures for the control, use, acquisition, end accountability of byproduct, source, and special nuclear material managing and overseeing the MML monitoring the performance of the RCP Office and the RCPD, and audit the
=
implementation of the RCP advising senior executive management of the results of the MRSC audits and program reviews ensuring adequate resources are provided to implement the RCP, including
=
implementation of permittee radiation safety programs ensuring adequate resources are providtid for the training of MRSC, RCP and permittee e
staff ensuring that permitting and inspection staff are appropriately qualified as dese,ribed in NRC Inspection Manual Chapter 1246 (IMC 1246) i maintaining records under the MML reviewing permit applications and recommend action to be taken by the Chairman or his designated representative, meeting on at least a quarterly basis, with the required quorum, to review the activities a
j of the RCPD l
PG 6-02, Rev.1 14 09/25/97
maintaining a current list of quantities, uses, and locations where radioactive matenalis
+
received, possessed, used, or stored establishing procedures to control the procurement and acquisition of radioactive
+
material to ensure compliance with the MML ensuring inspections are conducted to assess permittee compliance with the provisions -
+-
of the NRC license, NRC regulations and of the specific permits.
establishing enforcement policies and procedures
+
advising senior executive management and NRC of all non compliance items potentially
+
categorized at severity levels I, ll, or 111 as identified in the NRC enforcement policy, pr0viding copies of permits and inspection reports to the appropriate NRC regional office
+
requesting assistance from appropriate individuals and licensee organizations when
+
necessary to assist the MRSC in the execution of its responsibilities establishing technical committees to extend staff capabilities for unique or technically
+
complex problems.
The applicant must provide its organizational and procedural manual (s) that addresses each of the above items The applicant must include the wntten delegation of authority for the MRSC, and its charter and quorum requirements (l. e., Chairman, RCPD, and two thirds of the remaining membership) with these documents. The applicant should also describe the conditions under which it will obtain assistance from technical boards and other entities and identify and describe any existing boards or entities that it user to support the MRSC.
4.10.6 The Radiation Control Program Director The responsibilities and authorities of the RCPD include, but are not limited to:
management and control of the RCP
+
serving as the Executive Secretary of the MRSC
+
being responsible for conducting day-to-day operations of the RCP and issuing permits
+
in accordance with procedures approved by the Chairman of the MRSC serving as the routine point of contact between the MML licensee and the NRC for matters concerning the MML l
informing the MRSC and senior executive management regarding the status of the RCP
+
implementing the MRSC's enforcement sanctions
+
=
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15 09/25/97
Stopping work activities which may pose undue risk or hazard or which may violate t
conditions of the license or the NRC regulations reviewing all radiologicalincidents and recommending corrective actions to the MRSC The applicant must provide a copy of the wntten delegation of authonty from the senior executive manager to the RCPD and a description of his/her responsibilities.
The applicant must provide documentation to show that the RCPD has access to the highest levels of MML management and the measure of administrative and financial control over permitting and inspection pe;sonnel.
i 4.10.7 Permitting and inspection Staff The MML licensee's permitting and inspection staff shalt:
provide guidance to licensee organizations in the preparation of requests for permits be responsible to provide content of NRC generic communications to appropriate e
perrnittees in a timely manner review permit applications for completeness and complit.nce with current regulations, policies and guides prepare permits and forward to the MRSC (or delegee) for review and signature perform inspections to assess compliance with current licensee and NRC regulatie4, policies, and guides and provisions of the MML and specific permits prepare reports of inspection results, and forward reports of non-compliance to the MRSC conduct technical assistance visits as necessary conduct pre licensing visits respond to incidents if the RCP staff are not co located, the applicant should desenbe in detail how the staff will effectively manage the day to day operations of the RCP, The applicant should describe how it will:
Respond to events at permittee facilities Maintain uniformity of program implementation Maintain daily communications 1
PG 6-02, Rev,1 16 09/25/97 l
l l
Ensure consistency of guidance provided to permittees Provide training to RCP staff Monitor and evaluate RCP staff performance
+
4.10.8 RCP Procedures
'The RCP must establish written internal procedures to assure that the MML satisfies NRC requirements ar.d enteria, the staff performs its duties as required, and to provide a high degree of uniformity and continuity in regulatory practices. These procedures should address intemal processing of permit tpplications, inspection policies and procedures, decommissioning, and other functions required of the program.
The MRSC must receive quarterly reports from the RCP staff on the status of the program. In addition, on an annual basis, the MRSC will *eceive a report on the audit of the program to include overall conduct, result of the program performance compared to regulatory requirements and commitments, review of permitting actions, inspection reports, and enforcement actions.
4.10.9 Management and Master Radiation Safety Committee Audits
'The applicant must provide its process describing senior executive management oversight and the mechanisms used by senior executive management to ensure that they are aware of NRC regulations, the provisions of the license, and the compliance status of the institution's RCF.
This oversight may include ! ( pendent audits of the program, frequent meetings with the MRSC, and periodic site visits of selected permittees.
The MRSC should be fully aware of the operations and activities of the RCP Officn through frequent and routine meetings. The MRSC should conduct interactive management audits and evaluations of the RCP office's performance, including the RCPD's. Results of the MRSC's audit and program reviews should be reported to senior executive management to allow for timely and aggressive remedial actions sufficient in scope to ensure compliance with NRw regulations and license conditions. A MML licensee should also consider establishing MR'3C subcommittees to evaluate and audit those areas of the program within their area of expertise, inspectors must demonstrate competonce in evaluating health and safety problems, and in determining compliance with NRC regulations. Inspectors must demonstrate to supervisory personnel an understandig of regulations, inspection guides, and policies prior to independently conducting inspections. The MML should establish a system similar to the NRC's qualification journal system found in IMC 1246. Audits of the inspectors and permit reviewers should be conducted on an annual basis. Guidelines should be adopted in advance of the audits establishing cnteria that will be used to determine acceptable versus unacceptable performance. Management policies and guidelines should be in place for reporting audits to senior executive management.
PG 6-02, Rev.1 17 09/25/97
'l The RCPD or the inspection staff supervisor must conduct annual field evaluations of each inspector to attess performance and assure appropriate and consistent policies and guides.
Permit reviewers must demonstrate competence in reviewing applications for permits. In addition, such reviewers must demonstrate an understanding of regulations, licensing policy and guidance directives, and permitting practices prior to independently reviewing and issuing j
permits. The MML should establish a system similar to the NRC's qualification journal system found in IMC 1246.
The RCPD must audit a sample of each permit reviewers actions to assess performance and assure appropriate and consistent policies and guides.
- The applicant must provide a copy of the process that is used to audit its inspection and normitting staff audit program.
4.10.10 Permitting Procedures The applicant must provide copies of its permitting procedures, policies and guides, if the applicant commits to utilizing NRC licensing procedures, policies, and guides, it may list those NRC documents used and only need provide those licensee documents that differ. The applicant must commit to update its permitting guidance as it receives updates to NRC licensing guidance. The applicant should provide in its application specific timeliness goals which it will apply to the issuance of permits and to the updating of its licensing guidance as updates are received from the NRC.
The RCP must establish procedures to assess the essential elements of permittee applications. These elements must meet current regulatory guidance for describing the isotopes and quantities to be used, qualifications of persons who will use material, facilities and equipment, operating and emergency procedures, and minimization of contamination, This information must be sufficient to establish the basis for permitting actions. Clear, complete, and accurate documentation of isotopas, forms, quantities, authorized uses, and permissive and restrictive conditions must be readily available for audit during pre-permitting visits. The RCP '
must have proced' ires for reviewing permits prior to renewal to assure that supporting information in the file reflects the current scope of the permitted program.
The RCP must have internal permitting guides, checklists, and policy memoranda consistent l
with current NRC licensing guidance. Permit applicants (including applicants for renewals) should be furnished copies of applicable guides and regulatory positions. Compliance history should be considered when issuing new pyrre,,r modifications to existing permits.
Standard permit conditions identical to current NRC standard license conditions should be used to expedite and provide uniformity in the permitting process. Custom Conditions may be developed provided they are not less restrictive then any applicable NRC requirements and cnteria. - Files must be maintained in an orderly fashion to allow fast, accurate retrieval of information and documentation associated with the permitting program. The applicant should provide a copy of the administrative procedures to accomplish this.
PG 6-02, Rev.1 18 09/25/97
4.10.11 Permitee Minimization of Contamination Program Applicants, for an MML after August 20,1997, must describe how facility design and procedures for operation will minimize, to the extent practicable, contamination of the permittees' facilities and the environment, facilitate eventual decommissioning, and minimize, to the extent practicable, the generation of radioactive waste. All MML applicants for a new license and their permittees need to consider the importance of designing and operatinr' the" facilities so as to minimize the amount of radioactive contamination generated at a site dui. ig its operating lifetime and to minimize the generation of radioactive waste during decontamination.
4.10.12 Permit Termination and Decommissioning of Permit Activities The NRC's requirements for termination of byproduct material licenses are described in 10 CFR Parts 30,40,and 70. The internal procedures that the NRC staff follow to terminate a byproduct materials license are in NRC IMC 2605. The applicant may either provide its permit termination procedures or commit that it will terminate its permits in accordance with NRC regulations, policies and guides as provided for in the LOU.
The NRC vacommissioning procedures are contained in NRC IMC 2605 and the Decommissioning Handbook. The applicant must provide its own deco imissioning procedres or commit that it will decommission permit facilities as described in the NRC IMC 2005 and handbook La provided for in the LOU..
The MML application must contain statements in which the applicant agrees to provide copies of permit termination requests and permit decommissioning plans. The applicant must further agree, when requested by NRC due to interest in a specific site, to submit specific permit decommissioning plans to the NRC for review and approval prior to approval by the MML RCP.
NRC will maintain the authonty to review and approve decommissioning plans on a case by.
case basis. However, in general, unless requested by the NRC, the MML may review and approve decommissioning plans.
4.10.13 Financial Assurance Decommissioning financial assurance requirements for NRC specific licensees are described in 10 CFR 30.35. The applicant must describe its program for establishing and maintaining adequate funds to decommission its permitted facilities. NFC uses NUREG 1336, Rev.1 and PcJicy and Guidance Directive FC 90-2.
4.10.14 Inspection and Enforcement Procedures The RCP Office ( RCPD and/or staff) must maintain an inspection program adequate to assess permittee compliance with NRC regulations, MML requirements, and permit conditions. The RCPD must maintain statistics which are adequate to permit program management to assess the status and results of the inspection program on a periodic basis. This statistical information must include the number of inspections _ conducted, the number overdue, the length of time overdue, and priority categories. This information must be readily available. The RCPD must I
prepare a semiannualinspection plan that includes the number of inspections to be performed, PG 6-02, Rev.1 19 09/25/97
the level of inspection experience required for the individual permits, identification of special needs, and periodic status reports for completion of the inspections within the plan's schedule.
The MRSC must el;her establish an inspection prionty system identical to the NRC's in Manual Chapter 2800 or the MML management may request authonzation from the NRC through tha MML's licensir g region to alter tho inspection frequency to meet the MML's priorities. The specific frequency of inspections must be based upon Pe potential hazard from permitted operations, e.g., broad scope permits, major processors and industrial radiographers must be inspected approximately annually und smaller or less hazardous operations may be inspected less frequently.
Inspection guides consistent with current NRC guidanco, must be used by inspectors to assure uniform and complete inspection practices and provide technical guidance in the inspection of permitted programs. Written inspection policies must be issued to establish a policy for conducting unannounced inspections, obtaining corrective action, following up and closing out previous violations, conducting interviews with workers and observing n,wations, assuring exit interviews with management and issuing appropriate notification ci violations ot health and safety problems. Independent measurements must be sufficient in number and type to ensure the permittee's control of materials and to validate the permittee's measurements.
The RCP must provide for in house laboratory support capability, or readily available through established procedures, to conduct bioassays, analyze environmental samples, analyze samples collected by inspectors, and other necessary analyses on a priority established by the RCP.
Procedures must be established for maintaining permittee compliance histories. Oral briefing of supervisors or the senior inspector should be performed upon return from non routine inspections.
For MML f acilities with separate pei Etting and inspection staffs, procedures must be established for feedback of inspectio nformation to permit reviewers.
Findings of inspections must be documented in a report desenbing the scope of inspections, substantiating allitems of noncompliance, and health and safety matters, describing the scope of permittees programs and indicating the substance of discussions with the permittee management and the permittee's response. Reports must uniformly and adequately document the results of inspections and identify areas of permittee's program which murt receive special attention at the next inspection. Reports must show the status of previous noncompliance and the results of any independent physical measurement made by the inspector.
The applicant must provide its permit inspection procedures as described above and iu procedures for documenting inspection findings and enforcement actions.
4.10.15 Incident / Emergency Response Procedures MML representatives must submit a wntten plan for response to such incidents as spills, over exposures. transportation accidents, fire, explosion, theft, or any other emergency situation that PG 6-02, Rev.1 20 09/25/97
may result from the specific nature of the licensee's activities The plan must define the responsibdities and actions to be taken by permr.J The plan must be specific as to persons responsible for initiating response actions, co ' Jeting operations, cleanup, and the RCP management, staff, and oversight.
Additionally, applicants who request possession of radioactive materials in both unsea!ed and certain sealed forms in excess of specifically listed quantities must address the need for an Emergency Plan, according to 10 CFR 30.32(l)(1). Should this assessment support the need for an emergency plan, a detailed plan pursuant to 10 CFR 30.32(l). Regulatory Guide 3.67,
" Standard Format and Content 'or Emergency Plans for Fuel Cycle and Materials Facilities,"
must be submitted.
The applicant must provide its RCP Office procc Nres for responding to spills, fires, release or loss of material, over exposures, and contamina' ion of personnel at permittee facilities. The applicant must desenbe its provisions for immediate response and handling of such incidents, including off hours notification of appropnate RCP Office staff, State and local authontic., and, when applicable, the NRC. Except for minor spills or releases of radior.ctivity that can be controlled and cleaned up by the permittee, the permittee staff should understand what actions must be taken to secure the area, respond to immediate hazards, and whom they should contact. Only qualified and expenenced individuals should conduct decontamination and recovery operations.
The applicaat's RCP Office emergency response procedures must require that inquiries be promptly made to evaluate the need for onsite review of events. Onsite review of events must be initiated promptly for incidents which are required to be reported to NRC within less than 30 days. For those incidents not requiring repc ting to NRC in less than 30 days, review of events must be made during the next scheduied inspection. Onsite investigations must be made I
promptly of non reportable incidents which could be relevant to other permitted operations (e g.,
equipment failure, improper operating procedures) and those incidents which may be of significant pubhc interest and concern.
Information on incidents involving failure of equipment must be provided to the agency responsible for evaluation of the device for assessment of possible generic design deficiency (NRC and Department of Health and Human Services, Food and Drug Administration).
The applicant should establish an Emergency Response Team composed of individuals experienced in various emergency response functions (e g., radiological, medical, emergency management, secunty, and fire protection).
The applicant must provide its incident / emergency response procedures as described above.
Information that must be included in these procedures include, but is not limited to, the following:
Initial response actions and responsibilities, including immediate safety.
Precautions for people and property at permittee facilities.
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Area and pertnittee facility access control and secunty.
Mechanisms and responsibil.t.es for notifying RCP Office staff and external authonties.
Provisions for medical and offsite agency assistance.
A description of emergency response equipment available for use by the RCP Office staff 4.10.16 Procedures for Handling Allegations The applicant must confirm that it will follow the NRC's procedures for handling allegations or previde equivalent procedures for nandling allegations that are referred to the MRSC.
MML applicants must establish a program for responding to employee radiation safety concerns. This program must provide for timely investigation and response to these concerns and address prevention of reprisals against employee's concerns for expressing their radiation safety concerns to management. The program must include training that clearly articulates the right of any employee to raise their radiation safety concems directly to NRC, if they so desire.
Allegations received by NRC staff from licensee personnel may be investigated by the NRC or referred to the MRSC for investigation. Those allegations referred to the MRSC must be handled ;n the same manner as the NRC would and as described in Management Directive 8.8.
The applicar.t must prov;Je its procedures for handling and documenting employee concerns, and must specify what training will be provided to all employees to assure they understand their right to contact NRC directly about radiation safety or regulatory issues. The program should include a strong statement encouraging employees to bring fomard any perceived radiological safety issues.
4.11 HRC Form 313 ITEM 11 WASTE MANAGEMENT The applicant must describe the methods its permittees will use for disposal of radioactive waste. The folluvving disposal methods will be authorized:
transfers to a recipient (usually a waste disposal service company or the original
=
supplier) who is properly licensed to receive such waste in accordance with 10 CFR 20.2001(a),
decay-in-storage, disposal of materials that contain radioactivity from hydrogen-3 and carbon-14 in scintillation counting media and in animal tissue in concentrations of 0.05 microcune or less per gram, subject to certain restrictions stated in 10 CFR 20,2005, and release of radioactive materials into air and water in conformance with 10 CFR 20.1302 and 20.2003, PG 6-02, Rev.1 22 09/25/97
Other disposal rnethods must be specifically addressed iri the application. This may include, but is not limited to, treatment or disposal by incineration, land burial, or consohdation of wasts from multiple permittee facilities for subsequent disposal.
The applicant must desenbe the locations, conditions, and current status of former buriet sites, i.e., controlled or uncontrolled, any active monitoring of the site, and the current condinon of the burial site, for permittees who were NRC licensees authorized prior to January 28,1931, to bury radioactive materials pursuant to 10 CFR 20.304.
4.12 NRC Form 313. Item 12. License Fees No application fees, license fees, amendment fees, approval fees, or inspectiori fees are required for a U. S. Government agency. However, in accordance with 10 CFR 171.16(d) an annual fee will be assessed.
5.0 AMENDMENTS TO A LICENSE lt is the licensee's obligation to keep the license current. If any of the information provided in the original apphcation which was included in the license tie-down condition is to be modified or changed, the licensee must submit an application for a license amendment before the change takes place. A licensee must receive a hcense amendment before changing the scope of the program, changing the Radiation Control Program Director, or changing the Chairman of the Master radiation Safety Committee..
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Applications for license amendment, in addition to the following, must provide the appropriate fee. For amendment requests applicants must do the following:
Be sure to use the most recent guidance in preparing an amendment Submit in duplicate, either an NRC Form 313 or a letter requesting amendment.
Provide the license number, Provide a complete and up-to-date application if many outdated documents are referenced or there have been significant changes in regulatory requirements, the licensee's organization, or radiation control program. Alternatively, describe clearly the exact nature of the changes, additions, and deletions.
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GUIDANCE FOR SPECIFIC LICENSES OF BROAD SCOPE 2nd Qwarter 3rd Quarter 4th Quarter 1st Quarter l 2nd Quator 3rd Quarter 4th Quer Task Name Start Finish Apr l May l Jun Jul l Aug l Sep Oct l Nov l Dec Jan l Feb l Mas l Apr l May l Jan Jul l Aug l Sep Oct l Now Begin Draft NUREG 4/6/98 5/22/98 l
Management Review - two 5/25/98 8/13/98 9
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l Publish for public comment 8/248 11/26/98 3
l Resolve comments and 11/27/98 4/29/99 revise 'focument Pubrash in Final 4/30/99 4/30/99 L
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