ML23153A055

PR-033 - 61FR58346 - Specific Domestic Licenses of Broad Scope for Byproduct Material Advanced Notice of Proposed Rulemaking

ML23153A055
Person / Time
Issue date:	11/14/1996
From:	Hoyle J NRC/SECY
To:
References
PR-033, 61FR58346
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ADAMS Template: SECY-067 DOCUMENT DATE: 11/14/1996 TITLE: PR-033 - 61 FR58346 - SPECIFIC DOMESTIC LICENSES OF BROAD SCOPE FOR BYPRODUCT MATERIAL ADVANCED NOTICE OF PROPOSED RULEMAKING CASE

REFERENCE:

PR-033 61FR58346 KEYWORD: RULEMAKING COMMENTS Document Sensitivity: Non-sensitive - SUNSI Review Complete

DOCKET NO. PR-033 (61FR58346)

In the Matter of SPECIFIC DOMESTIC LICENSES OF BROAD SCOPE FOR BYPRODUCT MATERIAL ADVANCED NOTICE OF PROPOSED RULEMAKING DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 11/13/96 11/06/96 FEDERAL REGISTER NOTICE - ADVANCED NOTICE OF PROPOSED RULEMAKING 12/02/96 11/27/96 COMMENT OF THE UNIVERSITY OF SOUTH CAROLINA (DR. DANIEL M. ZUROSKY) ( 1) 01/29/97 01/24/97 COMMENT OF CAROLS. MARCUS, PH. D., M.D. ( 2) 02/04/97 01/23/97 COMMENT OF NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY (LYMAN PEVEY AND CHRIS KUYATT) ( 3) 02/07/97 02/07/97 COMMENT OF AMERICAN COLLEGE OF NUCLEAR PHYSICIANS (MARVIN B. COHEN, M.D., PRESIDENT) ( 4) 02/10/97 02/07/97 COMMENT OF ILLINOIS DEPARTMENT OF NUCLEAR SAFETY (STEVEN C. COLLINS) ( 5) 02/10/97 02/04/97 COMMENT OF COUNCIL ON RADIONUCLIDES AND RADIOPHARMACEUTICALS (LEONARD R. SMITH, VICE CHAIRMAN) ( 6) 02/10/97 02/05/97 COMMENT OF MACK L. RICHARD ( 7) 02/12/97 01/21/97 COMMENT OF TWO OFFICALS OF THE UNIVERSITY OF WYOMING (JIM HERROLD) ( 8) 02/12/97 02/04/97 COMMENT OF PHARMACIA & UPJOHN, INC.

(LAWRENCE J. KENAGA) ( 9) 02/12/97 02/10/97 COMMENT OF AMERSHAM HOLDINGS, INC. (WAYNE LONDON) ( 10) 02/12/97 02/10/97 COMMENT OF ESMERALDA PARTY AND AMY WILKERSON ( 11) 02/12/97 02/11/97 COMMENT OF ABBOTT LABORATORIES (DEBRA J. HILLMAN) ( 12) 02/12/97 02/07/97 COMMENT OF MERCK & CO., INC. (EDWIN A. WURTZ, PH.D.) ( 13) 02/14/97 12/29/96 COMMENT OF ARA TAHMASSIAN, PH.D. ( 14)

DOCKET NO. PR-033 (61FR58346)

DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 02/14/97 02/11/97 COMMENT OFF. X. MASSE ( 15) 02/18/97 02/08/97 COMMENT OF MAYO CLINIC (RICHARD J. VETTER) ( 16) 02/18/97 02/08/97 COMMENT OF HEALTH PHYSICS SOCIETY (RICHARD J. VETTER, PRESIDENT) ( 17) 02/18/97 02/17 /97 COMMENT OF 3M HEALTH PHYSICS SERVICES (DUANE C. HALL) ( 18)

. 02/18/97 02/08/97 COMMENT OF MICHAEL J. BOYLE ( 19) 02/19/97 02/15/97 COMMENT OF TIMOTHY P. HART ( 20) 02/19/97 02/12/97 COMMENT OF DUPONT EXPERIMENTAL STATION (AUGUSTO CORDOVA) ( 21) 03/07/97 02/28/97 COMMENT OF NATIONAL INSTITUTES OF HEALTH (ROBERT A. ZOON) ( 22) 04/07/97 04/03/97 COMMENT OF AMER. COL. NUC. PHYSICIANS/SOC. NUC. MED.

(MARTIN L. NUSYNOWITZ, M.D., ET AL.) ( 23)

. 03/19/98 03/19/98 FEDERAL REGISTER NOTICE - ADVANCED NOTICE OF PROPOSED RULEMAKING: WITHDRAWAL

DOCKETED USNRC [7590-01-PJ "98 MAR 19 P4 :4 0 NUCLEAR REGULATORY COMMISSION 10 CFR PART 33 RIN 3150-AF54

• SPECIFIC DOMESTIC LICENSES OF BROAD SCOPE FOR BYPRODUCT MATERIAL AGENCY: U.S. Nuclear Regulatory Commission.

ACTION: Advance Notice of Proposed Rulemaking: Withdrawal.

SUMMARY

The U.S. Nuclear Regulatory Commission is withdrawing an Advance Notice of Proposed Rulemaking (ANPR) that discussed possible changes to the regulations governing specific domestic licenses of broad scope for byproduct material. Additionally, NRC is announcing plans to finalize draft guidance currently contained in Draft Regulatory Guide DG-0005, "Applications for Licenses of Broad Scope, Revision 2," as a NUREG.

FOR FURTHER INFORMATION, CONTACT: Torre Taylor, U.S. Nuclear Regulatory Commission, Office of Nuclear Material Safety and Safeguards, MS T8F5, Washington, DC 20555, Telephone (301) 415-7900.

2 SUPPLEMENTARY INFORMATION: On November 14, 1996 (61 FR 58346), the Commission published an ANPR for 10 CFR Part 33, "Specific Domestic Licenses*of Broad Scope for Byproduct Material." In the ANPR, the Commission explained that it is considering amending these regulations to clarify the regulatory and health and safety basis of current licensing practices and to provide licensees with the flexibility to make certain types of changes to their radiation safety programs .

• The comment period expired February 12, 1997. The Commission received 22 comments on the ANPR. The commenters were composed of broad scope academic and medical facilities; professional associations; private citizens; an Agreement State program; a Federal government agency; and private industry. The majority of commenters responded negatively to the ANPR. After reviewing the comments, NRC has decided to withdraw the ANPR.

NRC is announcing plans to finalize draft guidance currently contained in Draft Regulatory Guide DG-0005, "Applications for Licenses of Broad Scope, Revision 2," as a NUREG. This NUREG will update existing draft guidance and will be published for public comment. A notice of availability of the NUREG will be published in the Federal Register. This effort is part of an ongoing project to update and consolidate existing guidance. As part of this project, the NRC staff plans to evaluate the licensing process and license conditions for ways to provide greater flexibility for broad scope licensees to modify their program without seeking a license amendment within the constraints of the existing regulations in 10 CFR Part 33. All

3 comments received in response to the ANPR will be considered in the development of this NUREG.

Dated at Rockville, Maryland, this /?'1:: day of March, 1998.

• For the Nuclear Regulatory Commission.

JohnJiHoyle, Secretary of the Commission.

filW/R 0 American College of Nuclear Physicians/Society of Nuclear MeJilc9~SKtflJ GOVERNMENT RELATIONS OFFICE

°97 APR -7 P3 :15 DOCKET NUMBER April 3, 1997 PROPOSED RULE PR 33 OFFICE OF SE CRf.TARY OOCKETlttG & ?LRvl CE John C. Hoyle, Secretary ( t.o/ FR5'83t/lo) BRA l-tCrl Nuclear Regulatory Commission Washington, D.C. 20555-0001 Attn: Docketing and Service Branch RE: Advance Notice of Proposed Rulemaking, Specific Domestic Licenses of Broad Scope for Byproduct Material; 61 FR 58346, November 14, 1996.

Dear Secretary Hoyle:

The American College of Nuclear Physicians and the Society of Nuclear Medicine would like to provide the following comments on the above referenced document for your consideration. 1 We would caveat these comments however, by pointing out that any meaningful reform of the broad scope licensing process should take place only after the Commission implements any regulatory reform initiatives for the medical program. This would allow those changes to be reflected in the approach taken towards broad scope licensees. We believe a scaling back of the medical program under 10 CFR 35 could also result in similar changes to medical conduct under 10 CFR 33.

General Comments:

The ACNP/SNM generally opposes the concept of codifying the nearly endless number of Specific Domestic Licenses of Broad Scope (SLBS) license conditions. Such a move would most certainly result in a highly prescriptive chapter of regulation. Instead, ACNP/SNM supports performance based regulations, but only when they set a standard, and allow the licensee to fulfill the standard through multiple mechanisms as applicable to the scope and nature of the licensee's program. ACNP/SNM want to stress that any revisions to part 33 must be performance based. Unfortunately, in the past the NRC has labeled regulations as performance based, when in reality they were quite prescriptive (e.g., Quality Management Program).

1 ACNP and SNM represent over 14,000 physicians, technologists, pharmacists, and scientists who provide quality nuclear medicine diagnostic and therapeutic services to patients and perform research and development in this specialty. Each year over 10 million nuclear medicine procedures are performed in the United States.

APR 1 4 1991- --

Acknowledged by card ......"....."..'""_:..;.,.,

1850 Samuel Morse Drive, Reston, Virginia 22090-5316 * (703) 708-9773 I Fax: (703) 708-9777

.5. NUCLEAR REGULATORY COMM1::i::,1(.)o DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics Postmark Date ~ -

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ACNP/SNM Comments on Broad Scope ANPR April 3, 1997 Page2 Some of the topics the NRC is concerned with are: the roles of the Radiation Safety Officer (RSO), Radiation Safety Committee (RSC), Authorized User (AU), and the types, quantities, uses, inventory, security, control, storage, and disposal of byproduct material.

While some of these topics clearly need amplification in the regulations, many do not.

The subjects of inventory, security, and control are all closely interrelated, and subject to independent review by the NRC. Any action taken on these subjects should apply across the board to all licensees. Storage and disposal regulations suffice in their current form and require no additional amplification by the NRC.

Types, quantities, and uses of byproduct material are closely related to the subjects of RSC and AU. The credentials of the members of the RSC, and the qualifications of the AU should be commensurate with the proposed types, quantities, and uses of material for that specific license. Some SLBS will be research (bench and human subject) and medical, some SLBS will be non-human subject research only. Obviously the qualifications of AU's (and those of the members of the RSC) will have to be dependent on the proposed uses. However, there are some basic common qualifications that all AU's should possess. Again, depending on the extent of the types, quantities, and uses of byproduct material at a SLBS, the qualifications, and duties of the RSO will vary.

AU: AUs in a SLBS will typically be professionals, either researchers or scientists, using byproduct material in specific applied fashions. The RSC should be able to determine whether or not its own AU is qualified, because the RSC is intimately familiar with the uses of byproduct material at its facility. In a research setting, most researchers (AUs) use only a few isotopes, and use them in very specific amounts and methods. In these cases the RSC could certify each AU for as many isotopes and techniques as the AU can present credentials for.

AU as supervisor: Provided that the AU only supervises workers operating with in the scope of authorization for that AU, a simple performance based rule would suffice: "An AU may supervise the work of others within the scope of the AU's authorization from the RSC. The licensee (RSC and RSO) shall determine the scope of authorization granted to the AU in the licensee's license."

Requirements for AU: A successful candidate for AU will at a minimum:

• demonstrate proficiency with 10 CFR part 20;

• understand the basics of radiobiology;

• have knowledge of laboratory techniques associated with safe handling of radioactive material;

• know the basics of dosimetry;

• be proficient in the basics of radiation safety (time, distance, and shielding);

• have knowledge of basic radiation physics;

• be proficient in the use of radiation detection and survey instruments;

ACNP/SNM Comments on Broad Scope ANPR April 3, 1997 Page3 Traditionally SLBS are designed to have maximum flexibility, as such a setting demands it. Prescriptive regulations for SLBS would have serious detrimental effects. It would be far more productive to have basic performance guidance for these licenses. For example, part 33 could state that the licensee (and its management) is responsible for:

• radiation safety audits;

• inventory;

• security and control; (However, all three of these issues are covered in part 20 as they apply specifically to SLBS.)

Additionally, the licensee should be able to make changes in its Radiation Safety program that allow it to function at the same or at an improved (improved includes economic improvements) level provided that the RSO and RSC approve. The NRC should be notified of such changes in a timely manner (e.g. on an annual basis). Such changes would include changing members of the RSC, dosimetry providers, calibration vendors, etc. ACNP/SNM supports a provision similar to§ 50.59 being added to part 33.

ACNP/SNM is concerned that the NRC in this ANPR is relying on the two internal contamination problems which occurred last year to imply all SLBS have a similar problem. In both of these cases, the internal contamination appeared to have been the deliberate work of a knowledgeable individual, e.g. criminal action. The ACNP/SNM agrees with the NRC when it stated: "Generally, 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. For the three year period from 1993-96 there were only 38 events involving these licenses that resulted in some enforcement action." On the issue of security and control (the underlying issue in the two internal contamination cases) the NRC is working to resolve the incomplete and conflicting guidance currently existing. ACNP/SNM believes that this is the appropriate mechanism for solving this problem, and that it should not be handled separately in the revision of part 33.

Draft NUREG 1516, Management of Radioactive Material Safety Programs at Medical Facilities (RSO NUREG) is referenced in this ANPR numerous times. ACNP/SNM believe the RSO NUREG, although a draft, is far from being a suitable document for management. It contains factual errors, is excessive in length (repetitive), is highly prescriptive, and tends to reflect the ideas of its primary author (i.e., this is not a consensus document). Additionally, it offers little advice on today's topics of interest which include inventory, security, and control.

ACNP/SNM Comments on Broad Scope ANPR April 3, 1997 Page4 Specific Questions in ANPR:

Question 1: Should the responsibilities of licensee management for the radiation safety program be specified in part 33?

Answer 1: No, by signing the license and providing the financial assurance documents management is aware of the responsibility. Generally management does not possess radiation safety expertise, and to make a list for them would be a waste of resources. It would be far more productive to ensure that management hires a competent RSO, appoints a qualified RSC, and mandates that they ensure that the license and regulations

- are not violated.

Question 2: Should the NRC incorporate requirements for the duties and responsibilities of the RSO and the RSC?

Answer 2: No, nothing more than a simple statement for the RSO like: "to ensure that NRC regulations and license conditions are followed." For the RSC: "to review the workers and work to ensure that the regulations and license conditions are followed."

Question 3: Should specific minimum training and experience criteria for authorized users be incorporated into part 33?

Answer 3: Yes, but the training must be so generic as to allow a wide variety of AU's to be appointed. For instance, there is a wide difference in education, training, and experience between a MD/Ph.D. doing biomedical research on human subjects, and a chemist using tritiated compounds to determine chemical stability. It is the areas of commonality that must be described in the minimum training and experience criteria.

(See our previous suggestions.)

Question 4: Should the NRC incorporate specific requirements for inventory and accountability of byproduct material in use, or modify its existing guidance?

Answer 4: No, do not incorporate specific requirements, simply modify the existing guidance. SLBS are quite varied, any specific requirements will merely limit flexibility.

SLBS need flexibility to solve complex problems created by the extreme variety and amounts of byproduct material used by their AU. Additionally, the requirements for inventory and accountability apply to all NRC licenses, and the NRC is revisiting this issue separately. ACNP/SNM support this review, part 33 should not be the site of an attempted solution.

ACNP/SNM Comments on Broad Scope ANPR April 3, 1997 Page 5 Question 5: Should the NRC consider the risks associated with internal exposure pathways (e.g., ingestion, inhalation, absorption) separate from those associated with external radiation?

Answer 5: No, ACNP/SNM feel that absorbed dose is absorbed dose. There is no need to place any quality factors on dose simply based on its route of administration.

Question 6: Are there other specific aspects of the draft regulatory guide DG-0005 that should be codified in part 33?

- Answer 6: No.

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

§50.59?

Answer 7: Yes, ACNP/SNM supports such a move. See our previous detailed comments.

Question 8: Should the different types of broad scope licenses currently in part 33 (types A, B, and C) be deleted and replaced with a single type?

Answer 8: No, continue to maintain A, B, and C SLBS. Obviously there is an advantage for the 60 some B and C licensees, otherwise they would have converted to specific licenses of limited scope.

Question 9: Should a category for Master Materials Licenses be incorporated into part 33 with the respective necessary requirements?

Answer 9: Yes, this would facilitate corporate entities with multiple locations to obtain a master materials license. Corporate entities with multiple locations would apply for a multi-site license (vide infra). Master materials licenses are for entities such as the Uniformed Services or Federal Agencies. See discussion on this topic in the ACMUI minutes from the November 1996 meeting.

Question 10: Should requirements for Multi-Site Facilities be codified in part 33 or should this be defined only in 10 CFR part 30?

Answer 10: Yes, the minimum requirements should be codified in a manner analogous to the requirements for SLBS.

ACNP/SNM Comments on Broad Scope ANPR April 3, 1997 Page6 Question 11: What balance should be maintained between a performance-based and a prescriptive approach to regulating broad scope licensees?

Answer 11: The balance between performance and prescriptive based approaches to regulating SLBS should be weighted heavily in favor of performance based standards.

Comments on the proposed rule language (p. 58350):

§33.2 Definitions: To AU add: "the authorization to use and the type of use are specific to the license." To management add: "management is responsible for compliance with the rules, regulations, and license conditions."

§33.5 Records: No Comment

§33.11 Type of specific licenses of broad scope: No Comment

§33.12 Applications for license, amendment, or renewal:

(A) No Comment (B) NRC should have a clause allowing for application without this requirement - a new entity with the right professionals could do this ...

(C) same comment as B above (D) No Comment (E) No Comment (F) No Comment (G) ACNP and SNM disagree with NRC; management would lack the expertise to perform a review. This would have to be contracted out, or done in-house using the radiation safety personnel.

§33.17 Requirements of specific licenses of broad scope: No Comment

§33.21 Radiation Safety Officer:

(A) No Comment (B) Delete the words "in physical or biological science or engineering." This is too specific. Each RSO applying for such a position will need to have had specific training and experience, the actual degree title may be immaterial with respect to qualifications.

§33.22 Radiation Safety Committee: No Comment

ACNP/SNM Comments on Broad Scope ANPR April 3, 1997 Page7

§33.23 Statements of authority and responsibility:

(A)(l) No Comment (A)(2) Replace "in which health and safety may be compromised to an unacceptable level" with "in which health and safety are compromised by exposure levels in violation of the regulatory limits." The remainder of §33.23 will suffice.

§33.25 Supervision: No Comment

§33.59 Radiation safety program changes: No Comment The ACNP and SNM would like to work closely with the Commission as it contemplates making large scale changes such as these, but again must reiterate that the Commission would benefit from developing changes to other areas first. The reform of 10 CFR 35 may produce useful regulatory models that could then be applied to 10 CFR 33. For further information or questions, feel free to contact Mr. David Nichols at (703) 708-9773.

~ ~1-; ~~P.

Sincerely,

~~_.. .. .)-

Martin L. Nusynowitz, M.D. Michael D. Devous, Sr., Ph.D.

President President American College of Nuclear Physicians Society of Nuclear Medicine

DEPARTMENT OF HEALTH&. HUMAN SERVICES Public Health Seovlce DOCKETED USNRC National Institutes of Health Bethesda, Maryland 20892 Secretary

'97 HAR - 7 P3 :11 Nuclear Regulatory Commission FEB 2 8 1997 Washington, D.C. 20555-0001 Attention: Docketing and Service Branch DOCKET NUMBER

Dear Sir or Madam:

PROPOSED RULE PR 3 3 (t;JF~ 831/,to)

The Radiation Safety Branch (RSB) of the National Institutes of Health (NIH) has reviewed the Proposed Rulemaking for "10 CFR 33: Specific Domestic Licenses of Broad Scope for Byproduct Material" dated November 6, 1996, and wishes to offer the following comments.

The RSB is concerned that the NRC is taking hasty action to initiate changes to regulations which would impact fill licensees when the problems identified in the "Background" discussion as precursors to the proposed rulemaking were the result of failures at only a small number of facilities. In fact, the NRC acknowledges this by stating "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" (Federal Register Vol.61, No.221 , p.

58347). The NRC has provided little or no evidence ofreal damage or harm to persons or property to justify these proposed changes. Rather than providing specific examples of events that directly threaten the public as a result of weak controls by the RSO or RSC, the NRC vaguely indicates that "these types of events, which could potentially [italics added] result in doses to the public from radioactive material in unrestricted areas, are often [italics added] the result of weak controls by either the RSO or RSC"(Federal Register Vol. 61 , No.221 , p. 58347).

In fact, later in the "Background" discussion, the NRC only provides evidence of one event in which weak management oversight was linked to an internal contamination incident. And yet, even in this case, the weak management oversight was characterized as a "contributing factor" and not the cause of the incident.

It appears that the NRC is attempting to control individual human behavior which will always remain beyond the control of any governing agency. What the NRC is proposing is simply a paperwork exercise, which will not significantly improve the fine performance that the majority of broad scope licensees exhibit. The level of management oversight necessary to provide for the safe use of byproduct material is entirely dependent upon the people doing the managing and those being managed. It is not appropriate for regulatory agenci_es to stipulate how licensees must manage their radiation safety programs. Rather, the role of regulatory agencies is to review the results achieved by the regulated community and determine whether or not the results achieved are satisfactory. When the results are not satisfactory, the regulators are required to take action to bring the licensee into compliance. Recent NRC action to extend from 5 to 10 years the period that licenses are effective would appear to support that, contrary to the implications in the proposed rulemaking, broad scope licensees exhibit excellent compliance with and understanding of existing regulations.

MAR 1 3 1997 144!..........

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In addition, it is our opinion that the NRC should do more to provide licensees with official positions or statements regarding licensing and operational expectations. The NRC frequently relies on draft guidance to mold their regulatory program, as evidenced by the fact that Draft NUREG 1516 (published in January 1995) and Draft Regulatory Guide DG-0005 (published in October 1994) are referenced in this advance notice of proposed rulemaking as examples of information that licensees should consider in preparing these comments. Also, it is common for the NRC to ask licensees to use draft regulatory guidance (such as DG-0005) in preparing licenses for submittal. This places the potential licensee in the position of using dated materials which do not have any final official status. Licensees would be best served if the NRC would finalize draft guidance documents in a timely manner and publish them as official positions.

The NIH Radiation Safety Program has complete management support from NIH officials, including involvement in the day to day operations. Therefore, we feel qualified to address the following questions presented by the NRC:

1. Should the Responsibilities ofLicensee Management for the Radiation Safety Program be Specified in Part 33?

We do not believe that additional regulations specifying the responsibilities of the licensee management are necessary. It would be more beneficial to issue regulatory guidance which combines the Draft Regulatory Guide NUREG 1516 with Draft Regulatory Guide DG-005. While these two documents address the needs of a medical licensee, the concepts could be developed and finalized to accommodate other types of broad scope licenses.

Each licensee should be afforded the flexibility to design a radiation safety program that keeps health and safety in the forefront of operations while maintaining control over the program activities. The RSO and RSC should maintain the flexibility to operate within the management structure and mechanisms for control as they see fit, without the need to seek NRC approval. The final mechanism for evaluating the effectiveness of the guidance should be a compliant radiation safety program, not a checklist regulation where the licensee loses the flexibility of controlling its own radiation safety program.

2. Should the NRC Incorporate Requirements for the Duties and Responsibilities of the RSO and the RSC?

The RSB agrees that there should be some guidance concerning the roles and responsibilities of the RSO and the RSC. However, this guidance should not be in the form ofregulation as proposed in 10 CFR 33.23(b). The authority, duty, and responsibilities of these entities change throughout the course of a radiation safety program. Consequently, the licensee needs flexibility in a program in order to adjust to changes in the program over time.

2

In the proposed 10 CFR 33.21(b), the NRC is prescribin2 specific expectations for the training and experience of an RSO. Requiring the RSO to have a degree may place an additional, unnecessary burden on a licensee. An individual without a degree may be better qualified if he/she has extensive, relevant experience through employment at similar licensed facilities. For example, small companies may not have the funding to meet the additional salary demands from an individual with a degree, as opposed to an individual without a degree, but with extensive experience.

Moreover, there is a concern that NRC may eventually require the RSO to be a Certified Health Physicist and/or to possess a Ph.D. in related fields. The RSB urges the NRC to retain the specifications of an RSO as outlined in the current 10 CFR 33.13(c)(2) and 10 CFR 33.14(b)(l ).

3. Should Specific Minimum Training and Experience Criteria for Authorized Users be Incorporated Into Part 33?

Specific minimum training and experience criteria for authorized users should definitely N OT be incorporated into Part 33 . The NRC needs to recognize that each license is unique and that personnel qualifications and experience vary among institutions. Placing specific criteria into the regulations forces a standard that may not be feasible or appropriate for all licensees. For example, an authorized user at the NIH may be a laboratory technician, laboratory chief, or even a Scientific Director. Some of our most effective authorized users do not meet the expectations of the current 10 CFR 33.lS(b)(l), but instead have only received training as outlined in 10 CFR 33.15(b)(2).

The criteria for authorized users should only be addressed in guidance documents. At a minimum, the guidance for authorized users should stipulate the training and experience as detailed in the current 10 CFR 33 .15(b)(2). The RSO and the RSC should retain the authority to judge the credentials/criteria for proposed authorized users based on the needs of the program. Otherwise, the licensee may lose some of the best authorized users and strong advocates of the radiation safety program due to a simple regulatory clause that automatically excludes them from consideration.

4. Should the NRC Incorporate Specific Requirements for Inventory and Accountability of Byproduct Material in Use or Modify Its Existing Guidance?

The current 10 CFR 33.13 (c) requires that "the applicant has established administrative controls and provisions relating to . .. material control .... " The same requirement is outlined for Type B and C licensees. This may be interpreted as requiring licensees to have an inventory and accountability program in place to control the byproduct material received. Existing and draft regulatory guidance documents address material inventory and accountability (see DG-0005, section 10.3, and Regulatory Guide 8.23, section 1.16.2). The NRC should expand upon the existing requirements through guidance 3

documents which provide more detailed information as to examples of inventory and accountability programs the NRC would deem acceptable. Using guidance documents to present this information affords licensees the flexibility to tailor their individual programs to meet the intent of the regulations. During license application reviews and on-site inspections, the NRC can determine whether or not the proposed or existing inventory and accountability program is adequate.

5. Should the NRC Consider the Risb Associated With Internal Exposure Pathways (e.g.,

Ingestion, Inhalation, Absorption) Separate From Those Associated With External Radiation?

The NRC made great strides in 1994 with the revised 10 CFR 20 by incorporating the concept of the "Total Effective Dose Equivalent" (TEDE) which is consistent with the philosophy of the ICRP and NCRP. The NRC should not reverse itself. The NRC already has methods to adequately manage radiation exposures, as detailed in each licensee's ALARA program.

The RSB is concerned that if the NRC is proposing to consider risks from internal and external exposures separately, then there is an implication that the risk from internal is worse than the risk from external exposure or vice versa. Additional perceived risks lead to additional precautions and regulations. However, additional precautions and regulations would not have prevented either of the two P-32 incidents referred to by the NRC. Neither was associated with routine use ofradioactive materials or caused by faulty procedures within the lab environment. Rather they resulted from deliberate, malicious misuse of radioactive material.

The Federal Register states "Although the Commission recognizes that there may be greater uncertainties with the estimation of internal exposure, the revision of 10 CFR 20 assumes that internal and external exposure are equivalent in terms of risk." While there may be uncertainty in calculating the dose estimates from internal uptakes, this does not mean that the associated risks from internal/external doses should be treated separately.

There is no perfect situation which patterns Reference Man. However, with competent bioassay programs in place and the ability to adjust dosimetry models to fit specific cases, accurate doses can be obtained with valid statistical precision.

6. Are There Other Specific Aspects of the Draft Regulatory Guide DG-0005 That Should be Codified in Part 33?

The NRC states that "There are currently no specific requirements in 10 CFR 33 addressing these topics .... " The "topics" referred to by the NRC include "administrative procedures, material inventory and accountability, audits and appraisals, safety evaluations and exposure control." The NRC has adequately addressed these topics in the current 10 CFR 33.13(c), 33.13(c)(3)(i-iii), 33.14(b), 33.14(b)(2)(i-iii), and in 33.lS(c), and they are specific enough. The NRC can provide more specific 4

"guidance" in the Draft Regulatory Guide DG-0005, but should not place any additional specifications in the regulations. No other aspects of the Draft Regulatory Guide DG-0005 should be codified.

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 CFR 50.59?

The NRC should permit the licensees to make changes in their radiation safety programs without the interference of the NRC, as long as safety is not compromised in the process.

Allowing changes to the radiation safety program to be approved by the RSC rather than the NRC provides flexibility for licensees and avoids long delays before implementation of programmatic improvements. For example, in January 1996, the NIH submitted a license amendment to the NRC pertaining to security policy changes. To date, the NRC has not acted on this amendment. Consequently, the NIH has been forced to administer an antiquated policy which has cost the NIH significantly in terms of person-hours and supplies and equipment which may become obsolete if the NRC approves the amendment.

In the proposed 10 CFR 33.59(a), the NRC states that "the holder of a specific license of broad scope for byproduct material may make changes in the facility or procedures as described in the license application, after review and approval by the Radiation Safety Committee, without prior Commission approval unless the proposed change involves a change in a specific license condition or is less restrictive than the regulations." The NRC needs to clarify "unless the proposed change involves a change in a specific license condition." For example, the NIH was forced to submit a license amendment to computerize our radioactive material ordering system. The NRC insisted upon the license amendment because they interpreted the change from paper to computer to be a change in a specific license condition. The NRC may want to provide examples of changes they deem acceptable under the proposed regulation.

8. Should the Different Types ofBroad Scope Licenses Currently in Part 33 (Types A, B, and C)

Be Deleted and Replaced With a Single Type?

The NRC should not condense the three types of broad licenses into a single type. It appears that the NRC is attempting to pigeonhole varying degrees of regulatory oversight into one category, and this is not practical for the NRC or the licensee. Currently, Type B and C licensees do not require an RSC because these programs involve possession of limited quantities of radioactive materials and may be indicative of small operations. If the NRC were to combine all types of licenses into one, then everyone would be expected to have an RSC as stipulated in the proposed 10 CFR 33.22. This may present an unreasonable and unnecessary financial and managerial burden on small programs.

5

Based on the proposed Part 33 regulations, the specific expectations outlined in 10 CFR 33.12 "Applications for license amendments, or renewal," 10 CFR 33.17 "Requirements of specific licenses of broad scope," 10 CFR 33.21 "Radiation Safety Officer," and 10 CFR 33.22 "Radiation Safety Committee," are too prescriptive for some of the smaller Type B and C licensees. For example, if the NRC were to eliminate the three types of licensees, there would be an increased cost to the Type C licensees to ensure compliance with the single type license. The Type C licensee would have to institute an RSC, hire or appoint an RSO, and modify the program to conform with the expectations outlined in the proposed 10 CFR 33. This is over-regulation based on no apparent safety issue.

11. What Balance Should Be Maintained Between a Performance-Based and a Prescriptive Approach to Regulating Broad Scope Licensees?

There needs to be more flexibility within the regulations to permit licensees to tailor each program to meet the specific needs of the facility. The NRC can suggest plans to assist in implementing a sound and safe program, but they must recognize that one answer, i.e.,

prescriptive regulations cannot be applied to all situations. The NRC must use the licensing and inspection programs to evaluate the adequacy of the licensees' programs and the risk associated with the type of materials in use.

The RSB would like to see the NRC take a performance-based approach to assess compliance with the regulations. However, this will not have an impact on the licensees unless the inspection/enforcement programs are similarly performance-based. Currently, the inspection/enforcement programs are not focused on the true safety aspect of radiation protection. Instead, the inspections in many cases focus on a prescriptive approach such as a signature on a piece of paper.

The RSB is encouraged by the four key elements identified by the NRC staff and wishes to comment on each:

(1) There are measurable or calculable parameters to monitor licensee performance The RSB is concerned with the concept of measurable or calculable parameters.

During recent inspections by the NRC, it became clear that the NRC is looking for 100% compliance. This may not be achievable in all situations, particularly where human behavior is involved. The NRC should establish parameters which permit a certain percentage of compliance taking into consideration the size of a facility. Certainly a licensee that has 100 labs, 15 of which have failed to comply with contamination survey requirements is more of a problem than a licensee that has 3500 labs, 15 of which have failed to comply. The NRC recognized this when revising its enforcement policy on June 30, 1995. In Federal Register Vol.

60, No. 126, p. 34385, the Commission states that "there are other violations of minor safety or environmental concern which are below the level of significance 6

of Severity Level IV violations. These minor violations are not the subject of formal enforcement action."

(2) objective criteria are established to assess performance These objective criteria should be made available to the licensees so that they know what they are being judged upon. Based on many years of inspection experience, it appears that the NRC inspectors have a specific agenda or focus for each inspection, but that agenda or focus changes each time. The NRC's current top priority appears to be the security of radioactive materials, whereas a few years ago it was "hot" particles and skin contamination. Before that, it was radioactive releases to the environment. Thus, licensees continually must guess as to what the NRC's latest focus will be and what new interpretations of existing regulations will be used to assess compliance.

(3) licensee has the flexibility to determine how to meet established performance criteria It is important to recognize that each licensed facility has different operating parameters. By establishing guidelines and allowing the licensees to develop specific procedures to guarantee compliance, the NRC provides the licensee with much needed flexibility to operate a successful radiation safety program. Note that the licensee should be permitted to change the written policies and procedures used to maintain compliance without NRC involvement or second-guessing.

(4) failure to meet a performance criterion will not have an intolerable outcome In the event that the licensee has written policies and procedures in effect and an active enforcement program, the NRC must recognize that errors and violations occur due to individual human behavior. Consequently, self-identified violations are a sign of a successful program with reviews and audits that work! Therefore, the licensee should not be further penalized for self-identified violations where corrective actions have been taken and proven successful.

We hope that these comments are useful in your review of the proposed revision to 10 CFR 33.

<2.

Please feel free to contact me at (301) 496-2254 if you have any questions regarding these comments.

DEPARTMENT OF Robert ~-~O~

Radiation Safety Officer, NIH HEALTH & HUMAN SERVICES Nat. Institutes of Haaith Radiation Safety Branch Building 21, Room 110 21 Wilson Dr., MSC 6780 7

Bethesda, MD 20892-6780

DOCKET NUMBER DOCKETED PROPOSED RULE p 33 IJSNR C February 12, 1997 ( (p I Ff_ 5 g 3 '-f fp)

Secretary, "97 FEB 19 P3 :51 U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 OFFI CE OF SECRE Tt~RY OOC f\

J,.{ T 'iiI' (' j' C' ,... '} IJ""' F ut ~) ,. , I L,-*

Attention: Docketing and Service Branch Pt\1 1C:l

Subject:

Proposed Rule: Specific Licenses of Broad Scope for Byproduct Material. Federal Register, Vol. 61, No. 221, November 14, 1996.

These comments are submitted by the Radiation Safety Officers of the DuPont Experimental Station, DuPont Stine-Haskell Research Center and DuPont Merck Glenolden Laboratory. These research and development facilities serve the DuPont Company and the DuPont Merck Pharmaceutical Company. They each possess an NRC license for the use of radioactive materials in research projects involving basic research, the identification and development of pharmaceuticals for human health care or the development and study of crop protection products.

General Comments The Commission is concerned when it becomes aware of radiation protection programs that do not meet the commitments made in the licensee's application; we share that concern. However, codifying as requirements, ~ licensees operate will not address performance concerns. Further, creating a "one size fits all" radiation safety program is not feasible.

As noted within the Background section of the proposed rulemaking, "Part 33 reduces the administrative burden for both licensees and the Commission, without reducing safety standards or lessening licensing requirements for training, experience, facilities, and equipment." For over 30 years this regulation has been successfully used to provide a performance standard that ties in well with Part 30. From time to time Regulatory Guides have been provided to the licensed community to help them develop license applications and the resulting radiation protection programs. These Guides encourage the use of available technology and in improved administrative, engineering and support systems. These Regulatory Guides have been useful tools but they remain useful only if they are viewed and used within their intended purpose - to provide examples of acceptable ways to structure a radiation protection program.

1 FEB 2 0 1997

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If Draft Regulatory Guide DG-0005, or any guidance document, is converted into a prescriptive regulation its value is greatly diminished. This is due to the inherent nature of specific licenses of broad scope - to ensure safety protection programs are developed and in place despite a large and changing variety of operations involving byproduct material. Under many circumstances, operations will be encountered where a more flexible approach will be required. A lack of flexibility will create dilemmas involving the As Low As Reasonably Achievable (ALARA) principle, the prescriptions proposed and the reasonable objectives of the licensee.

Some organizations will be able to deal with the resulting dilemma by relocating to locations outside the NRC's jurisdiction. However, for most licensees this option is not feasible and they will have to change their definition of what is reasonable - either in their ability to reduce radiation exposure or in their ability to meet their objectives, or both. This outcome is contrary to the intent of the Commission, yet this would be the result under the proposal.

The proposal would be more effective within an updated Regulatory Guide. This would allow the Commission, the licensee and the public to benefit from the recent, as well as future, advances in radiation protection program design and operations. The regulation, Part 33, should be updated to encourage and allow licensees to make prompt improvements in their radiation protection program, without the delays and burden of intensive documentation and NRC notification and approvals. The regulation should also allow nonsubstantive changes to be made in a licenses program, without NRC notification and approvals. Changing to another the licensed vendor for leak testing services is an example of a nonsubstantive change.

In summary, the regulations for specific licenses of broad scope should be remain performance based. Each licensee should be evaluated on a case by case basis when prescriptive requirements are needed. Regulatory Guides have their value in providing examples while allowing alternative solutions to be developed and evaluated.

We appreciate the opportunity to provide comments on the proposal. Feel free to contact us for additional discussion or clarification.

Sincerely,

[document retrieved from Electronic Bulletin Board]

Augusto Cordova, RSO DuPont Experimental Station Norman Henry ill, RSO, CIH Stine-Haskell Research Center John Nicholson, RSO DuPont Merck Pharmaceutical Co.

2

Specific Responses to Questions

1) Should Licensee Management Responsibilities Be Specified In Part 33'1 The regulation should clarify that licensee management is ultimately responsible for the radiation protection program; while regulatory guidance should provide examples on how these responsibilities can be described within the license application. This will clarify that the licensee has the need and the responsibility to determine the most effective mechanism for management oversight of the radiation protection program.

2) Should the NRC Incorporate Requirements for the Duties and Responsibilities of the RSO and RSC?

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 licensee's program and the duties and responsibilities assigned. to the RSO and the RSC. It is not feasible to provide one set of criteria that would be appropriate for all broad scope licensed facilities.

There are many ways for an RSO and RSC to become qualified to meet their responsibilities and duties. Specifying their responsibilities and duties, and their minimum qualifications, would be a disservice to the licensee and the effected personnel. It would raise unnecessary barriers to qualified people while generating a false sense of confidence in personnel lacking the necessary qualifications to maintain an effective radiation protection program.

3) Should Specific Minimum Training and Experience Criteria for Authorized Users Be Incorporated Into Part 33'1 The operations, duties and responsibilities of Authorized Users vary greatly, even within a licensed programs. It is therefore not feasible to develop useful criteria for minimum training and experience. A Regulatory Guide would be the place for providing sample sets of operations, duties and responsibilities, matched with minimum training and experience criteria.

As with any other operation, it is management's responsibility to ensure personnel have the training and experience necessary to work safely and in compliance with regulatory requirements. These issues are best handled on a case by case basis.

3

4) Should the NRC Incorporate Specific Requirements for Inventory and Accountability of Byproduct Material in Use, or Modify Its Existing Guidance?

NRC Region I's workshop on Security and Control of Licensed Material provided an excellent opportunity for the licensees and the regulators to discuss the advantages and limitations of various systems and criteria for inventory control and accountability.

There was general consensus around the need for control systems that are reasonable, i.e., based on the quantity and hazard potential of the byproduct material. Further, many licensees described control systems they developed that met their operational needs and took advantage of the particular strengths of their facility.

It is imperative any regulation on security and control measures have provisions for considering the quantity, form and hazard potential of licensed material. For smaller quantities of material, e.g., one Annual Limit on Intake (ALI), licensees should be able to apply the same control criteria applied to non-radioactive reagents commonly present in research laboratories. A Regulatory Guide should include examples for meeting the security and control requirements, leaving implementation details to the licensee. NRC inspections would be used to ensure the programs in place are effective.

5) Should the NRC Consider the Risks Associated With Internal Exposure Pathways Separate From Those Associated With External Radiation?

Committed Effective Dose calculations are already used to relate internal exposure to external exposure so the current NRC practice for evaluating risk from internal vs.

external exposure is appropriate. It is also consistent with the recommendations of the National Council on Radiation Protection and Measurements and the International Commission Radiological Protection. Additional or separate dose limits are therefore not necessary.

At the same time, internal exposure prevention programs may require more controls than external exposure prevention programs. For this reason licensees often have more demanding systems where there is potential for internal exposure. A Regulatory Guide can provide examples of programs for internal exposure prevention but licensees need to be able to evaluate the operating conditions and the practices in place when developing and implementing their internal and external exposure prevention programs.

4

6) Are There Other Specific Aspects Of The Draft Regulatory Guide DG-0005 That Should Be Codified In Part 33?

Draft Regulatory Guide DG-0005 has value when it is used as intended - to give guidance by providing examples. It is too prescriptive to serve all broad scope license programs. The licensee's internal operating procedures and license application are the appropriate places for the level of detail described in Draft Regulatory Guide DG-0005.

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 Sec. 50.59?

Broad scope licensees have some flexibility in modifying their program without a formal license amendment application. This flexibility may be explicit, such as that provided through specific wording in the license or license application. In other cases program changes are possible since they are consistent with existing license conditions. Having this flexibility is vital for the licensee's radiation protection program to constantly improve. Having additional flexibility to make minor changes would facilitate and encourage licensees to incorporate program improvements before their license is up for renewal. Reserving the license amendment application process for more significant program changes would also reduce the administrative burden to the Commission and the licensees. Minor programs changes would be documented for the next NRC inspection.

8) Should The Different Types Of Broad Scope Licenses Currently in Part 33 Be Deleted And Replaced With A Single Type?

If broad scope licenses are limited to a single type, provisions will be necessary for small programs where the current Type A conditions and the limited scope conditions are not appropriate. Otherwise up to 25 % of current broad scope licensees will be forced to operate under license regulations that do not meet their needs. There should be a distinct and well-documented advantage to the licensees and/or public for this change.

l0)Should Requirements For " Multi-Site Facilities" Be Codified In Part 33 Or Should This Be Defined Only In 10 CFR Part 30?

A Regulatory Guide would be the best tool for addressing "multi-site" licenses. This would allow the Commission to provide the necessary guidance while providing the licensee the flexibility necessary to develop and implement an effective multi-site radiation protection program.

s

ll)What Balance Should Be Maintained Between A Performance-Based And A Prescriptive Approach To Regulate Broad Scope Licensees?

Regulations for broad scope licensees should be performance based. This is due to the inherent nature of the operations in a broad scope licensed facility. Prescriptive requirements would poorly serve the public, by reducing the effectiveness of the licensee's radiation protection program and increasing the administrative burden to the Commission and the licensee.

Prescriptive regulatory requirements are appropriate where measurable quantities are involved; examples include dose limits, possession limits and material release criteria.

Prescriptive requirements should also involve specific features of a licensee's program, such as the need for a Decommissioning Funding Plan.

It is important that the Commission remain in its oversight role, and not try to manage the radiation protection programs of the broad scope licensees. The Commission should provide guidance to the licensees through Regulatory Guides, while leaving program management to the licensees, who have the responsibility and capability to do so.

Strong action should be taken by the Commission when it becomes aware of a licensee lacking the capability or commitment to properly manage its radiation protection program. At the same time, it should not attempt to manage all of the broad scope licenses through additional prescriptive regulations.

6

From: Augusto A Cordova <cordova@a1.esvax.umc.dupont.com>

To: atb1@nrc gov <atb1@nrc.gov>

Date: 2/20/97 11 :54am

Subject:

Acknowledgement of Comments re: 10 CFR 33 Proposal

[This message is converted from WPS-PLUS to ASCII]

Per your phone message, here is my mailing address for sending an acknowledgement of the comments sent for the Proposed Rulemaking for 10 CFR 33 (Broad Scope Licenses).

Augusto Cordova DuPont Experimental Station P.O. Box 80272 Wilmington, DE 19880-0272 3o~ - &,95-~731 Thank you for the opportunity to comment on the regulatory proposal. I also appreciate the extra effort Carol Gallagher and you are making to have the original electronic submittal included in the comments files.

CC: NICHOLJJ <nicholjj@a1 .lldmpc.umc.dupont.com>

Tim Hart 7481 Matoaka Ave, Gloucester, Va. 23062 February 15, 1997 Secretary, Nuclear Regulatory Commission, Washington, D.C. 20555-0001

Dear Ladies and Gentlemen:

Enclosed are my comments the proposed rulemaking, 10 CFR Part 33 RIN 3150-AF54, Specific Domestic Licenses of Broad Scope for Byproduct Material (Enclosure (1)). My experience and background comes from five years with the U.S. Navy's Master Materials License as an inspector and license/permit reviewer. I also had eleven years with the Navy's Nuclear Propulsion Program.

I must state that these opinions are mine alone and do not in way reflect any past or current positions of the U.S. Navy.

Since~ , ~

Enclosures : ( 1)

~ ~- a; 7 o .22- I oo lfr FEB 2 0 1997

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Comment on Advance Notice of Proposed Rulemaking, 10 CFR 33 Specific Domestic Licenses of Broad Scope for Byproduct Material

1. The proposed rulemaking requests comment on amending the regulations governing specific licenses of broad scope for byproduct material to clarify the regulatory and health and safety basis of current licensing practices.

The rulemaking also aims to provide licensees with flexibility to make certain types of changes to their radiation safety programs. To ensure proper and effective management of radiation safety programs the NRC has used many tools including rulemaking, regulatory guidance, information notices, program inspections, and enforcement actions to name a few. While none of them alone is adequate, in unison they have served to provide a very high level of public safety. As an insight into the thirty plus years of broad scope licensing, in the proposal the NRC states "Generally, 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." When considering this to be true an obvious question becomes, is there a need for further codification of Part 33? I do not believe the case for amending the regulation is made in the proposed rulemaking. More detail in the regulatory guidance, in some cases, an increased vigilance during the license review process, and higher quality inspections can produce the desired effect with out handicapping or limiting the options available to the licensee. Repeated citing of the two P-32 incidents raises the specter that the Commission couldn't find just the right hook to hang someone.

Codification of existing guidance is not likely to prevent future events like these from occurring. Codification will however benefit the NRC by making violations easier for NRC inspectors to cite and somewhat easier for license reviewers to demand commitments in the license applications. Are the regulations being amended to give inspectors code to use when an aspect of the application was not adequately addressed during the licensing process?

2. As a side light, there appears an interesting paradox in this document.

Broad scope licensees are described as "certain licensees, who conduct varied and large-scale activities with licensed material under oversight by persons with extensive training and experience in radiation- safety" and who "do not require the same degree of regulatory oversight as do other licensees who perform similar or less complex activities with licensed material, but have less comprehensive radiation safety programs." Prescriptive regulations are suggested on topics such as management responsibilities and material inventory and accountability, which have no current regulatory basis. After offering such prescriptive regulations to a group of licensees that "do not require the same degree of regulatory oversight", the Commission reverses course. The suggestion that broad scope licensees be allowed to make changes in their radiation safety program without amendment piques the curiosity, leaving a question as to what direction the commission is really going.

3. In response to the Request for comments on General Considerations, I have the following specific comments;

a. Should the responsibilities of licensee management for the radiation safety program be specified in Part 33?

No. Management of a broad scope license may include some additional responsibilities, however management for all holders of NRC licenses for use of byproduct material is expected to be responsible for the conduct of the radiation safety program. NRC Information Notice No. 88-10, states that the "NRC holds licensee management, not the radiation safety staff or consultants, responsible for assuring the safe performance of licensed activities and adherence to NRC requirements." 10 CFR 20.1101 states the basic responsibilities of licensee management. Further codification is likely to be prescriptive and restrictive in the type of management review and will not Enclosure (1)

benefit licensees who have seriously examined how to comply with 10 CFR 20.1101. Since the licensee management for any program is responsible for their own radiation safety program, logic dictat es , if this truly is a problem, that a wider swath be cut by putting requirements in Part 20 or Part 30 vice Part 33. However an NRC Regulatory Guide, information notice, or a separate NUREG would be a more appropriate place to list management responsibilities.

b. Should the NRC incorporate requirements for t he duties and responsibilities of the RSO and RSC?

No. Regulation of this type is prescriptive thus limiting flexibility.

Most radiation safety programs have RSOs that oversee the day-to-day operation of the program. Further codifying the duties and responsibilities for an individual common to many programs begs the question, what are the duties and responsibilities of the RSO in other programs? Specifics such as this are prescriptive regulations and tend to limit the program options. For these reasons regulatory guidance is the proper venue for these duties and responsibilities.

While the RSC is unique to the broad scope program, each broad scope licensee by nature should have the freedom to tailor this aspect of the radiation safety program to fit the needs of its mission.

c. Should speci fi c minimum training and experience criteria for authorized users be incorporated into Part 33?

No. It is unclear as to why this question is being considered.

Specifying a certain level of education never has and never will replace responsibility and accountability. An endless list of responsible users without the required formal education could be paraded next to an equally long list of users with advance degrees whom the NRC has called to enforcement actions.

Broad scope licensees impaled on this cross will resort to naming a department head who never uses the material as the authorized user. This will be done to meet the education requirements because the technician who has been the named authorized user for the last twenty years only has an associates degree or less. This represents no improvement in radiation protection and encourages creation of unnecessary layers of management between the user and the radiation safety program.

d. Should the NRC incorporate specific requirements for inventory and accountability of byproduct material in use. or modify its existing guidance?

No. Inventory and accountability are issues which affects every type of licensee, but which currently have little regulatory basis in the current code.

Typically inventory requirements have been limited to two or three sentences as license conditions. The commission has issued little guidance on this topic, for any of the users licensed by the NRC. If the conduct and reconciliation of inventories is a problem for broad scope licensees who have a professional staff, are "other licensees who perform similar or less complex activities with licensed material, but have less comprehensive radiation safety programs" also having problems? If they are then lets fix the whole program. If they are not then the smaller programs might have some information to share with broad scope licensees. I have found some of the limited guidance for control and security of small sources inconsistent.

Guidance for the use, distribution, handling, accounting (particularly 2 Enclosure (1)

tracking of small quantities of short half-life isotopes), and disposal is lacking. Dealing with exempt quantities becomes even more confusing after reading some of the HPPOS, (HPPOS-043, 131, 136, 203, 272, and 275). As a n option to code in Part 33, specific wording in a regulatory guide would be more appropriate.

Accountability is addressed more than adequately by Part 20.1801 and 20.1802.

Effective enforcement actions can and should be based on these simple rules.

e. Should the NRC cons ide r the risks associated with internal exoosure pathways (e.g., ingestion, inhalation, absorption) separate from those associated with external radiation?

No. This topic was correctly dealt with in the revision to Part 20.

f. Are there o ther specific as pect s of the draft Regulatory Guide DG-0005 that should be codified in Part 33?

No. There are many fine pieces of information in the draft guide. With some editing and clarification this guide can provide excellent guidance and useful policy. Proper use of the guide, standard review plan, and pre-licensing visits by license reviewers can ensure that the licensees own document is strong enough and flexible enough to ensure an adequate radiation safety program.

g. Shoul d broad scope licensees b e allowed to make changes in their ra d iat ion safety program similar to those authorized for production and utilization facilities in Part 50.59?

Yes . This concept is in keeping with the idea of a broad scope licensees program of self-governing and self-evaluation.

h. Should the different types of broad scope licenses currentlv in Part 33 (Types A. B, and C) be deleted and replaced with a single type?

No opinion.

i. Should a category for "master materials licenses" be incorporated into Part 33 with the respective necessary requirements?

No. If this category is to be codified a stand alone Part would be more appropriate to avoid confusion with a broad scope license.

j. Should requirements for "multi-site facilities" be codified in Part 33 or should this be defined in only 10 CFR 30?

Part 30 would be more appropriate since multi-site facilities are used by many types of licensees.

k. What balance should be maintained between a performance-based and a prescriptive approach to regulating broad scope license?

Performance based objectives are preferred over codification of any existing licensing guidance. However it is recognized that a balanced approach of both prescriptive and performance-based regulations is needed to define a radiation safety program that allows licensees to use radioactive material safely and efficiently.

4. The following are comments on the specific examples of possible regulatory language provided by the proposed rulemaking. These comments assume that the commission determined that additional regulation is necessary therefore they do not repeat the above concerns.

3 Enclosure (1)

a. Section 33.12(h) (7) Item 9 of the Draft Regulatory Guide, DG-0005, requires the application include "the instrument calibration program, including calibration procedures and frequency ... ". Clarify whether or not the NRC desires to have such procedures included in the application.

b. Section 33.17(d) Item 7.2 of the Draft Regulatory Guide, DG-0005, requires a license amendment if the RSC chairperson changes. Reconcile the difference between the regulatory guide and the proposed language.

4 Enclosure (1)

February 8, 1997 DOCKETED DOCKET 'U, r*ER USN RC Michael J. Boyle PROPO ED AU E 33 205 Femwood Drive (&IF f.. 5834to) °97 FEB 18 P4 :15 Seneca, SC 29679 OFFICE OF ECRETAR Y Secretary, Nuclear Regulatory Commission DOCKETIN G & SERVICE Washington, DC 20555-0001 R/\NCH Attention: Docketing and Service Branch RE: Comment on Proposed Rulemaking, 10 CFR Part 33 I oppose the proposed wording contained in 10CFR33.2l{b}: "At minimum, the Radiation Safety Officer shall have an academic degree in physical or biological science, or engineering.... " My objection is focused on specifying the type of degree required to hold the position of RSO. I am currently certified by the American Board of Health Physics in the comprehensive practice of health physics. Adhering to the Certified Health Physicist's Code of Ethics, my current experience would preclude me from practicing as an RSO for a broad scope license. However, the proposed wording requiring a specific degree would exclude me indefinitely, with prejudice, from holding the RSO position since my academic degree is not in the specified field. Certification by the American Board of Health Physics is a widely recognized credential and is further accepted by 10CFR35.900(a)(l) as satisfying the qualifying requirements of RSO for the medical use of byproduct material. I contend that although the experiential requirements may differ, the academic requirements to hold the position of RSO under either 10CFR33 or 10CFR35 should be equivalent.

In summary, the proposed wording of 10CFR33.2l{b} should be changed to eliminate the requirement of an academic degree, especially in a specific discipline, if equivalent demonstration of appropriate academic knowledge and competency factors can be evidenced through certification by various acceptable certifying bodies such as those cited in 10CFR35.900(a}(l...9}.

Respectfully, Michael J. Boyle Certified Health Physicist FEB 2 0 t99f ltcknowledged by card*---~-*"-~

1-.S. NUCLEAR REGULATORY COMM1S::,10r, DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics Postmark Date o2hhz Copies Received I

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612 736 2285 Fax USHRC February 17, 1997

~?~~ET ~UM_B~!f p 33 "97 FEB 18 P12 :35 Attention: Docketing and Service Branch ( )

3IVI Secretary, Nuclear Regulatory Commission Washington, DC 20555-0001 (pf F~5g'3'flo OFFICE OF SECRET .RY OOCKETI 1G &. SEW/iCE BRANCH

Subject:

Comment on advanced notice of proposed rulemaking for 10 CFR Part 33 Following are some comments in response to your advanced notice of proposed rulemaking published in the November 14, 1996, Federal Register regarding "Specific Domestic Licenses of Broad Scope for Byproduct Material."

General Comment We want you to continue to maintain the Type B specific license category. We began operating under a Type A specific license of broad scope in 1964. We had the license changed to a Type B in 1974 and have operated successfully under this Type B since then.

We prefer to continue management of our activities by a Radiation Safety Officer (as under our Type B license). This is preferable over management by a Radiation Safety Committee (as under a Type A license). When we operated under a Type A, we found it difficult to create and maintain a group of people who were willing to dedicate time to sit on a Radiation Safety Committee. None of our authorized users nor management spends a majority of work time involved with uses of radioactive materials. In our facilities the amounts and types of radioactive materials, and the types of uses and users fit well under the Type B license format. We want you to continue to maintain the Type B specific license category.

Responses to Specific Questions

1. Should the responsibilities of licensee management for the radiation safety program be specified in Part 33?

The responsibilities of licensee management should be specified in Part 33. By specifying the responsibilities, it will be clearer what the NRC expects and it will be easier for us to communicate this to management. The responsibilities should be stated in terms of performance-based requirements as much as possible rather than prescription based.

2. Should the NRC incorporate requirements for the duties and responsibilities of the RSO and the RSC?

The requirements for 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.

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Comments on rulemaking for 10 CFR Part 33 February 17, 1997 Page2

3. Should specific minimum training and experience criteria for authorized users be incorporated into Part 33?

The training and experience criteria need to be flexible. Some authorized users require minimal training and experience. For instance, in our Type B license program an authorized user who only possesses exempt quantity unsealed material only needs one or two hours of radiation safety training. An authorized user who has a few Ni-63 electron capture detectors mounted on gas chromatographs only needs one or two hours of training. In contrast, an authorized user who handles millicurie amounts of unsealed material does need a BS degree in a technical area (or the equivalent training) and 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> of training and experience with similar materials. Thus the minimum training and experience criteria need to be flexible in order to match the criteria with the intended use and hazard of the material. The minimum training and experience criteria for authorized users should be stated in a Regulatory Guide and not be incorporated into Part 33.

4. Should the NRC incorporate specific requirements for inventory and accountability of byproduct material in use, or modify its existing guidance?

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 ALI may exceed the benefit. Specifying a quantity (some fraction of an ALI) 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.

5. Should the NRC consider the risks associated with internal exposure pathways (e.g.,

ingestion, inhalation, absorption) separate from those associated with external radiation?

External and internal radiation risks should not be separated. The Total Effective Dose Equivalent system of dosimetry should continue to be used.

6. Are there other specific aspects of the draft Regulatory Guide DG-0005 that should be codified in Part 33?

The material in draft Regulatory Guide DG-0005 should remain in the Regulatory Guide.

The Regulatory Guide material is too prescriptive to be codified.

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 Sec. 50.59?

A licensee should be allowed to make changes in the radiation safety program that will not reduce the safety of the program. This ability to make minor changes allows the licensee to make timely changes without the delay of processing a license amendment.

8. Should the different types of broad scope licenses currently in Part 33 (Types A, B, and C) be deleted and replaced with a single type?

We operate very successfully under a Type B broad scope license. We feel the Type B is appropriate for our radiation safety program. We want you to continue to maintain the Type B license category.

Comments on rulemaking for 10 CFR Part 33 February 17, 1997 Page3

9. Should a category for "Master Materials Licenses" be incorporated into Part 33 with the respective necessary requirements?

No comment.

10. Should requirements for "multi-site facilities" be codified in Part 33 or should this be defined only in 10 CFR Part 30?

The multi-site facilities requirements should be codified in Part 30.

11 . What balance should be maintained between a performance-based and a prescriptive approach to regulating broad scope licensees?

We encourage that the regulations be performance based. There are typically several good methods of complying with performance based regulations, and different methods will be more successful with different programs.

Comment on Draft Text We found the draft text to be good, with the exception that we want you to continue to maintain the Type B specific license category.

Sincerely,

~ t.~

DuaneC. Hall Manager, Health Physics Services

OOCKETEO

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• PROPOSED PAST PRESIDENT 1991-199s oocKE. T\N~ *c~ - ' V RICHARD J. VETTER BR .. . iI February 8, 1997 ( Co I F(<.583t/h Mayo Clinic Radiation Safety Office Rochester, MN 55905 Secretary, Telephone: (507) 284-4408 Nuclear Regulatory Commission FAX: (507) 284-0150 E-Mail: rvetter@mayo.edu Washington, DC 20555-0001 Attention: Docketing and Service Branch RE: 10 CFR Part 33 Advanced Notice of Proposed Rulemaking Thank you for the opportunity to comment on the Advanced Notice of Proposed Rulemaking (ANPR) regarding the amending of 10 CFR Part 33 . I am pleased to provide these comments on behalf of the Health Physics Society, a nonprofit membership organization dedicated to the safe and beneficial use of radiation. The Society membership includes some 6400 professionals many of whom are radiation safety officers or employees of broad scope licensees. The mission of the Society is to ensure that the benefits of radiation will be achieved with protection of public health.

We wish to respond to questions in your "Request for Comments on General Considerations:" The order of the questions has been changed to support our argument that highly trained RSOs would be expected to operate a more rigorous program than RSOs who have no special training in radiation safety and that performance based programs will achieve the mission of the licensee while assuring public health and safety.

Should the NRC Incorporate Requirements for the Duties and Responsibilities of the RSO and the RSC?

The qualifications for the RSO should be commensurate with the proposed types, quantities, and uses of the radioactive material. A broadscope license by design allows considerable 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 competency 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 FEB 2 0 1997

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Secretary, NRC February 8, 1997 Page2 management to the important position ofRSO for a broadscope license. An individual who is certified by the American Board of Health Physics or someone who has completed training similar to that specified in 10 CFR 3 5.900(b) is more likely to have the knowledge and insight expected to adequately protect public health and safety from activities associated with a broadscope license.

What Balance Should Be Maintained Between a Performance-Based and a Prescriptive Approach to Regulating Broad Scope Licensees.

We recognize that certain elements of a regulation must be somewhat prescriptive 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 prescriptive increase the cost of radiation safety programs without a concomitant increase in safety. Many members of the Society have experience in the implementation of 10 CFR Part 3 5 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 3 5 has significantly increased the effort required to maintain compliance without a concomitant increase in safety. A performance based approach would allow 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 the training and experience requirements for RSOs and authorized users, we strongly encourage the Commission to adopt a performance-based approach to the program as a whole.

Broadscope licensees (assuming the RSO meets rigorous training and experience requirements) should be allowed considerable flexibility to design and change their radiation safety program to assure that the licensee is meeting radiation safety performance goals while facilitating progress by users of radioactive materials. For example, if the licensee discovers a method to improve its program or to maintain the same standards at a lower cost, they should be allowed to make the change without a license amendment as long as performance based goals are achieved.

In response to the four key elements of a performance-based approach as suggested in the ANPR, we agree that such elements are essential for accomplishing the purposes of the Atomic Energy Act of 1974 as amended. For example, if the radiation dose limit to members of the public is 1 mSv, licensees should be allowed to demonstrate by measurement or calculation (including reasonable assumptions and occupancy factors) that no member of the public receives an effective dose in excess of this value. Criteria established to assess performance should be objective, e.g. can the licensee demonstrate that doses to members of the public are below the limits. The regulatory consequences for failure to meet performance criteria should be commensurate with the significance of

r* .,

Secretary, NRC February 8, 1997 Page3 the outcome. For example, an effective dose slightly in excess of the limit should be treated quite differently from an effective dose that results in deterministic effects.

Thank you again for the opportunity to comment on this ANPR. We would be pleased to provide further comment or discuss our thoughts in person if you desire.

Sincerely,

• R4J)if/~

Richard J. Vetter, President cc: Executive Committee Richard J. Burk, Jr.

Executive Secretary

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DOCKETED Mayo Clinic 200 First Street SW "97 FEB 18 A9 :34 Rochester, Minnesota 55905 507-284-2511 OFFICE OF SEC ET/ RY DOCKETING & SER\' ICE Richard J. Vetter, Ph.D.

February 8, 1997 BRAt~CH Radiation Safety Office 507-284-4408/Fax: 507-284-0150 Secretary, rvetter@mayo.edu Nuclear Regulatory Commission Washington, DC 20555-0001 KET U BER

• 33 Attention: Docketing and Service Branch ( it, I FY<58 3t/fo RE: 10 CFR Part 33 Advanced Notice of Proposed Rulemaking Thank you for the opportunity to comment on the Advanced Notice of Proposed Rulemaking (ANPR) regarding the amending of 10 CFR Part 33 . We wish to respond to three questions in your "Request for Comments on General Considerations:" The order of the questions has been changed to support our argument that highly trained RSOs would be expected to operate a more rigorous program than RSOs who have no special training in radiation safety and that performance based programs will achieve the mission of the licensee while assuring public health and safety.

Should the NRC Incorporate Requirements for the Duties and Responsibilities of the RSO and the RSC?

The qualifications for the RSO should be commensurate with the proposed types, quantities, and uses of the radioactive material. A broadscope license by design allows considerable 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 competency 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 management to the important position ofRSO for a broadscope license. An individual, 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 3 5. 900(b) is more likely to have the knowledge and insight expected to adequately protect public health and safety from activities associated with a broadscope license.

FEB 2 0 1997::-,r

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Secretary, NRC February 8, 1997 Page2 We also strongly recommend that the regulation allow the delegation of certain elements of the radiation safety program to other individuals within the licensee organization who meet the qualification requirements for RSO. In large programs, e.g. research/teaching universities or medical centers, several individuals may be needed in radiation safety to conduct a rigorous program. If these individuals meet the qualification requirements for RSO, the licensee should be allowed to appoint deputy RSOs who would become fully responsible for implementing and maintaining the radiation safety program for part of the organization. For example, within our organization where we have more than 1000 physicians on staff and a large research program, we appoint one health physicist to oversee the radiation safety program for the laboratory clinical and research programs, another to oversee the radiation safety program for diagnostic nuclear medicine, and a third to oversee the radiation safety program for radiation oncology and machine generated radiation. All three of these health physicists meet the training requirements specified in 10 CFR 35 Subpart J.

Should the Responsibilities ofLicensee Management for the Radiation Safety Program be Specified in Part 33?

We do not support the specification of licensee management responsibilities in Part 33 .

Management typically does not understand nor have the time to understand the complexities of a radiation safety program for a broadscope license. In fact, modem management philosophy suggests that employees should be empowered to carry out their responsibilities, which requires the appointment of highly trained individuals who are held accountable for achieving the goals of the program. A radiation safety program for a broadscope license with performance based goals should be managed by a highly qualified RSO who is accountable to licensee management for achieving the goals of a performance based program. We would be much more supportive of a performance based regulation that requires the appointment of a highly qualified RSO who would be expected to carry out a program that protects public health and safety.

What Balance Should Be Maintained Between a Performance-Based and a Prescriptive Approach to Regulating Broad Scope Licensees.

We recognize that certain elements of a regulation must be somewhat prescriptive 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 prescriptive increase the cost of radiation safety programs without a concomitant increase in safety. Many members of the Society have experience in the implementation of 10 CFR Part 3 5 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

Secretary, NRC February 8, 1997 Page 3 that the prescriptive nature of 10 CFR Part 3 5 has significantly increased the effort required to maintain compliance without a concomitant increase in safety. A performance based approach would allow 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 the training and experience requirements for RSOs and authorized users, we strongly encourage the Commission to adopt a performance-based approach to the program as a whole.

Broadscope licensees (assuming the RSO meets rigorous training and experience requirements) should be allowed considerable flexibility to design and change their radiation safety program to assure that the licensee is meeting radiation safety performance goals while facilitating progress by users ofradioactive materials. For example, if the licensee discovers a method to improve its program or to maintain the same standards at a lower cost, they should be allowed to make the change without a license amendment as long as performance based goals are achieved.

In response to the four key elements of a performance-based approach as suggested in the ANPR, we agree that such elements are essential for accomplishing the purposes of the Atomic Energy Act of 1974 as amended. For example, if the radiation dose limit to members of the public is 1 mSv, licensees should be allowed to demonstrate by measurement or calculation (including reasonable assumptions and occupancy factors) that no member of the public receives an effective dose in excess of this value. Criteria established to assess performance should be objective, e.g. can the licensee demonstrate that doses to members of the public are below the limits. The regulatory consequences for failure to meet performance criteria should be commensurate with the significance of the outcome. For example, an effective dose slightly in excess of the limit should be treated quite differently from an effective dose that results in deterministic effects.

Thank you again for the opportunity to comment on this ANPR. If you have any questions about our comments, please feel free to contact me.

Sincerely RuUL9 1~

Richard J. Vetter, Ph.D. CHP Radiation Safety Officer cc: Radiation Safety Committee

Environmental MASSACHUSETTS INSTITUTE OF TECHNOLOGY Medical MEDICAL DEPARTMENT DOCKE 77 MASSACHUSETTS AVENUE, 20B-238 USNR Service CAMBRIDGE, MASSACHUSETTS 02139-4307 "97 FEB 14 DOCKET NUMBERPB February 11 , 1997 PROPnSFD RULE ~3 OFFICE OF SECRETARY

( lP I Ff<5g3t.Jt,) OOCKET I 'G & SERV iCE e~ANC H Secretary Nuclear Regulatory Commission Washington DC 20555-0001 Attention: Docketing and Service Branch In response to the November 14, 1996, advance notice of proposed rule making, I wish to comment, based on my experience to date on the issues involved in broad scope licensure. My comments shall be based on the ten questions published in the December, 1996, issue of "Nuclear Licensing Reports" . Following are my comments on those ten questions:

(1 ) through (4) and (6) Experience over the past 10 years with Part 35 has led me to the conclusion that such prescriptive regulation is a mistake and should be avoided whenever possible. Regulations that are impractical or fail to serve the intended purpose are very difficult to change. There is strong resistance to any argument for exception or exemption from such regulations and it takes many months if not years to even obtain a headquarters response to a Technical Assistance Request. I therefore strongly urge that such requirements as the responsibilities of licensee management, the duties of the RSO and RSC, training and experience criteria for authorized users, and inventory and accountability practices be issued in the form of Guidance. This approach will leave crisp, easily readable regulations and allow the licensing staff the flexibility to issue licenses based on the specific needs and capabilities of a prospective licensee .

It should be noted that the stated reasons for considering the regulatory changes in this advance notice involved confusing and conflicting regulation and guidance, rather than a shortage of regulation. A careful review of NUREG 1535 will illustrate several examples of such conflicts, most of which are yet to be resolved. The addition of more prescriptive regulation will not carry with it any guarantee that we will get it right, only that it will be more difficult to correct the inevitable errors. In my opinion, expanded guidance is the preferred option and would provide needed flexibility.

(5) A key feature of the 1987 Presidential Guidance on ionizing radiation exposure was the provision that all radiation exposure be treated alike regardless of the pathway or delivery mechanism. This corrected the enormous bias that existed in the nuclear power industry where internal emitters were treated as much more hazardous than external sources. The definition of the Rem or Sievert is independent of the nature of the source and ICRP and NCRP do not distinguish between exposure from internal versus external sources in their guidance documents.

Regulations should observe scientific justification and logic and be unbiased regarding the source of the exposure. FEB 2 0 1997_

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Director Biohazard Assessment Industrial Hygiene Radiation Protection Reactor RPO Bates UNAC RPO 208-238 20C-21A 20C-20A Campus RPO 20C-207 NW12-108 P.O. Box 95 21 MaMing Road (617) 253-5360 (617) 253-17.40 (617) 253-2596 (617) 253-2180 (617) 253-.4203 Middleton, MA O194 9 Fax: (617) 253-4879 Fax: (617) 258-6107 Fax: (617) 253-4879 Fax: (617) 253-4879 ~m:idfda~kx (617)253-9217 Fax, (617)253-9599

,.S. NUCLEAR REGULATORY COMMl::i~ION DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics Postmark Date .;J /, , / tt '1 w Copies Received _____/_.,...__ __

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Nuclear Regulatory Commission February 11, 1997 Page 2 (7) The "ministerial" changes (as they are described in Part 35) that all broad license programs must occasionally make, and which have no significant effect on issues of concern to NRC, should be allowed to be made by Committee action, with appropriate records kept for NRC review. Properly done, this eases the burden of unnecessary amendments for inconsequential actions and allows the licensee to maintain the efficiency of his program.

(8) The three types of broad license in Part 33 continue to be useful if they are used as originally intended and with some flexibility by license reviewers (e.g. substitute committee for RSO or vice versa where appropriate) . However, the fee schedules have rendered these categories impractical except for fee-exempt licensees. If the higher annual fee is automatically applied to all categories of broad license, the smaller broad license programs will be forced to give up the broad license flexibility to avoid the excessive fee structure.

(9) I see no significant advantage to a "master" category versus a broad license such as that issued to MIT.

(10) 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.

(11) As indicated above, I feel that the prescriptive approach toward regulating medical licensees, while it may have been convenient to the regulators, has failed to adequately serve the licensee community, and the inflexibility with which the Part 35 regulations have been applied (including the resistance to change) has been detrimental to patients. I strongly urge that this unsatisfactory experience not be repeated for broad scope institutional licenses. I recommend that the program continue to be performance based with flexibility to maximize the advantages available at each licensed institution.

Yours truly, 0{76~/

F .X. Masse, CHP, CMP Director, MIT Radiation Protection Programs

Office of Environmental University of California, San Francisco ... A Health Sc;.ypes~ T ~

Health & Safety 50 Medical Center Way San Francisco, CA 94143 415/476-1300 OFFI CE OF SECRETARY DOC ET NUMBER p DOCKETING & SERV ICE BRANCH PROPOSED RULE 33

( {pl FY< 5'£531-/lo)

December 29, 1996 Doc!ceting and Sen'ice:= Br:mch Secretary Nuclear Regulatory Commission Washington, DC 20555-0001 This is with reference to the Commissions notice for revising the rules for Broad Scope Type A Licensees, which includes establishment of specific duties of RSO and RSC.

It appears that the main reason for this rule making are two:

1. Some licensees have not performed in accordance with their license criteria, or regulatory requirements.

2. There were two incidents which resulted in internal contamination.

I would like to comment on the applicability of each reason to establishment of additional regulatory burdens for licensees.

Point 1.

Current NRC and Agreement State regulations and requirements have substantial requirements for a description of the roles and responsibilities of the RSO and RSC, as well as an inventory control program.

These include detailed requirements for maintaining records of receipt, usage and disposal of the radionuclides authorized. In addition licensees are required to establish a system of record keeping to verify that the total quantities of radionuclides on hand do not exceed the licensed quantities.

Usually the roles and responsibilities are clearly defined in the Radiation Safety Manuals and application submittals. An organization chart is also included (at least for Agreement States) describing the line of authority.

The exact procedures for maintaining these records are included in the license application and reviewed at the time of approval, or renewal. Presumably these details meet the standards of NRC or the Agreement State reviewers, otherwise the license will not be granted.

FEB 2 Q 1997 *t ~

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Docketing and SeJVices Branch December 29, 1996 Page-2 In addition, each Broad Scope Type A licensee is inspected every two years. During these inspections the record keeping procedures are scrutinized in detail and their efficacy verified. Another item of inspection is the effectiveness of the Radiation Safety Program as a whole. The latter is an indicator of the overall control mechanism by which an inspector judges if the adequate management controls exist.

Point 2.

Presumably the two incidents are those occurring at the NIH and MIT. If this is the case, then their correlation to any management lapse in control of radioactive materials is irrelevant. As reported by the NRC investigators: in both instances, the incidents happened as a result ofthe deliberate act ofperson or persons unknown. Both individuals were contaminated in an approved laboratory, were approved users and were using an approved radionuclide. No matter how detailed any procedures are, or management responsibilities are codified, deliberate acts will be almost impossible to stop.

The current licensing and inspection structure provide adequate details for proper management of radioactive materials used under a Broad Scope Type A License. This is evident by the description in the "Notice for Proposed Rule Making" that there have only been a few instances of loss of radionuclides.

During a typical year hundreds of thousands (most institutions will receive 10,000 - 15,000 vials per year) of packages are delivered to licensees A few instances of loss of material, although undesirable, does not constitute a problem of lack of management control.

Broad Scope licensees operate under varied management schemes. It will be impossible to develop a "one-size-fits-all" package which will not force undue burdens on the institutions. The current systems in place are adequate and provide an appropriate degree of flexibility. If inspections by NRC or Agreement States identify a lack of appropriate management controls by a licensee, it is appropriate to force specific additional requirements on that licensee. However, it is not necessary to introduce another layer of bureaucratic requirements which will not contribute to any real health and safety.

Sincerely,

- ~~~-

si , Ph.D.

Director, Office of Environmental Health and Safety Radiation Safety Officer

Merck & Co.* Inc.

P.O. Box 4. WP42-2 West Point W>. 19486-0004 DOCKETED Fax 215 652 2266 USNRC DOCKET NUMBER P90PQSED RULE ff 33 *97 FIB 12 P4 :38

( {p/ F~ 583L/t:.)

OFFICE OF SECR ETAR Y DOCKETI NG & SERVICE h

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February 7, 1997 AN CH Research Laboratories Secretary United States Nuclear Regulatory Commission Washington, DC 20555-000 Attention: Docketing and Service Branch RE: Advance Notice of Proposed Rulemaking Specific Domestic Licenses of Broad Scope for Byproduct Material RIN 3150-AF54

Dear Secretary:

Merck & Co., Inc. would like to provide the following comments concerning the Advanced Notice of Proposed Rulemaking addressing the Specific Domestic Licenses of Broad Scope for Byproduct Material.

BACKGROUND Merck & Co., Inc. is a large pharmaceutical company, developing pharmaceutical products in all major therapeutic categories. As part of the search for new drugs, the company uses radioactive material in many applications throughout its research and development program. Authorization to use the radioactive material is granted by two separate Licenses of Broad Scope for Merck's Rahway, New Jersey and West Point, Pennsylvania sites. These Broad Scope Licenses authorize nearly 1,000 individuals to work with radioactive material in more than 500 laboratories.

ANALYSIS 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 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." We agree. Only 38 events involving broad scope licensees occurred that resulted in some type 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 individuals working with radioactive material at broad scope programs. Many of the aforementioned 38 events that resulted in enforcement involved loss of control of radioactive material, release of material in excess of the limits in 10CFR20, or rr 1 3 1997*

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Secretary 2 February 7, 1997 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 small incremental increase in risk that these incidents posed do not justify overhauling the broad scope regulatory framework that has proven effective for many years.

In 1993, NRC medical licensing and inspection programs were reviewed and it was determined that many significant radiological problems identified in medical programs are a consequence of licensee management and RSO failure. The subsequent report recommended that current NRC requirements and guidance on the responsibilities of RS Os at all materials facilities should be examined. When comparing a medical program with a research (broad scope) program, the RSO position is very different. In a medical program, the RSO is quite often a physician. His primary duty is the practice of medicine and his collateral duty is radiation safety. In a research based broad scope program, often the RSO's only duty is radiation safety. Therefore, RSO failures in medical programs are not indicative of potential RSO failures in research broad scope programs.

A response is provided to the questions applicable to our regulated program that were posed in the advanced notice of Proposed Rulemaking.

1. Should the Responsibilities of Licensee Management for the Radiation Safety Be Specified in Part 33?

No. The responsibilities of licensee management are currently established through the licensing process and this regulatory practice has proven effective. The responsibilities of Licensee Management are well-defined in Draft Regulatory Guide DG-0005. Since the radiation safety function may reside in a different area in each licensee's organization, e.g. Safety and IH, Research, Administration, then it makes more sense to address this issue specifically in the licensing process and not generically by regulation.

2. Should the NRC Incorporate Requirements for the Duties and Responsibilities of the RSO and the RSC?

No. The duties and responsibilities of the RSO and RSC are currently established through the licensing process and this regulatory practice has proven effective. The duties and responsibilities of the RSO and RSC are well-defined in Draft Regulatory Guide DG-0005. Broad scope programs vary in size and complexity and to attempt to codify the duties and responsibilities of the RSO and RSC in a generic regulation would prove inefficient.

The NRC should attempt to establish the minimum training and experience criteria for the RSO at a broad scope program. A grandfather clause for RSOs currently managing a radiation safety program must be considered.

Secretary 3 February 7, 1997

3. Should Specific Minimum Training and Experience Criteria for Authorized Users Be Incorporated into Part 33?

Training and experience criteria for authorized users should not be incorporated into the regulations and is better addressed in guidance documents. Current licensing practices are effective for establishing minimum training and experience criteria for authorized users for Broad Scope Licensees. The small number of incidents involving personnel are more often the result of poor attitude as opposed to the lack of training and/or experience of the individual involved.

4. Should the NRC Incorporate Specific Requirements for Inventory and Accountability of Byproduct Material in Use, or Modify Its Existing Guidance?

No. Current regulations and licensing guidance are more than sufficient to provide the regulatory framework to assure adequate security and control of small quantities of byproduct material. No regulatory program can preclude deliberate acts of noncompliance which were the root cause of one of the internal contamination incidents.

Apart from the cases involving deliberate acts, the present regulatory process is providing adequate protection to employees and the public from significant radiation risk.

5. Should the NRC Consider the Risks Associated with Internal Exposure Pathways (e.g., Ingestion, Inhalation, Absorption) Separate from Those Associated with External Radiation?

No. In 1987, the NCRP published Report No. 91 and recommended that the limits for exposure to ionizing radiation be expressed in terms of total effective dose equivalent.

The basis of the effective dose equivalent system assumes that internal and external exposures are equivalent in terms of risk. Seven years later the NRC incorporated the recommendations of the NCRP into 10CFR Part 20 and licensees have implemented the "new" Part 20. The efforts of licensees to implement the "new " Part 20 were not trivial.

In light of these efforts, it would not be appropriate for the NRC to begin to consider the risks from internal exposure separately from the risks from external exposure because some workers and the public perceive that greater protective measures are needed for internal exposure.

6. Are There Other Specific Aspects of the Draft Regulatory Guide D6-0005 That Should Be Codified in Part 33?

No comment.

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 Sec. 50.59?

Yes. Broad Scope licensees, with the review and approval of the RSO and/or RSC, should be allowed to make minor changes in their radiation safety program that is

Secretary 4 February 7, 1997 described in their license application so long as the change will not degrade radiation safety at the licensee's facility. This will allow the radiation safety staff more time to audit and monitor radiological conditions at the facility and less time will be spent filing trivial license amendment requests.

8. Should the Different Types of Broad Scope Licenses Currently in Part 33 Be Deleted and Replaced with a Single Type?

No comment.

9. Should a Category for "Master Materials Licenses" Be Incorporated into Part 33 With the Respective Necessary Requirements?

No comment.

10. Should Requirements for "Multi-Site Facilities" Be Codified in Part 33 or Should This Be Defined Only in 10CFR Part 30?

No comment.

11. What Balance Should Be Maintained Between a Performance-Based and a Prescriptive Approach to Regulating Broad Scope Licensees?

Risk-informed, performance based regulations are most desirable to the regulated community. Performance-based regulations allow for flexibility but still focus the licensee's efforts on the bottom line which is protecting the health and safety of employees, the general public, and the environment. Prescriptive regulations often are difficult to implement and sometimes it is not evident that these regulations actually reduce radiation risk.

I am sure that this comment will receive careful review and consideration before the proposed rule is issued. I would also welcome an opportunity to discuss this matter with a member of the NMSS staff. I can be reached at (215) 652-4890.

Sincerely, E r~CJal~

Director Health Physics, Biosafety, and Environmental Affairs EAW:pjo

a ABBOTT DOCKETED USNRC Corporate Health and Safety D-501 AP51 Abbott Laboratories "97 FEB 12 P2 :Q2 200 Abbott Park Road 847/938-2582 Fax: 847/937-9679 Abbott Park, Illinois 60064-3537 OFFICE OF SECRETARY DOCKETING & SERVICF 11 February 1997 BRANCH Secretary DOCKET NUMBER Nuclear Regulatory Commission PROPOSED RULE PR 33 Washington, DC 20555-0001

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Attn: Docketing and Service Branch Re: Specific Domestic Licenses of Broad Scope for Byproduct Material, RIN 3150-AF54 Abbott Laboratories is pleased to be able to comment on the Advance Notice of Proposed Rulemaking (ANPR) regarding Specific Domestic Licenses of Broad Scope for Byproduct Material. Abbott Laboratories is a leading world-wide manufacturer of health care products with headquarters in North Chicago, Illinois.

Abbott Laboratories believes that the existing regulations in 10 CFR Part 33 should be retained because they contain the most options and preserve resources for both the Nuclear Regulatory Commission (NRC) and the licensee. The existing regulations contain minimum requirements that are clarified in guidance. This allows the licensee some flexibility in the development of compliance strategies to meet the regulations. Abbott Laboratories does not support prescriptive changes to the regulations because they eliminate this flexibility. The prescriptive approach to regulations also has direct implications for U.S. industry in terms of increased cost and competitiveness in a global market.

The NRC requested comments on a variety of general considerations, and Abbott would like to comment on several of these specifically.

1. The NRC should not eliminate Type B and C broad scope licenses in favor of Type A.

Abbott believes that Type B and C licenses are needed for efficient management of programs having a broad scope of activities but limited byproduct materials needs. The imposition of Type A administrative controls on successful Type Band C licensees would add unnecessary burden, delays, and ultimately costs without benefit.

FEB 1 3 1997

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2. For the reasons stated above, Abbott believes that the NRC's position on the following should be provided in guidance, not in IO CFR Part 33 :

• Duties and responsibilities of the Radiation Safety Officer and the Radiation Safety Committee

• Responsibilities of licensee management

• Minimum training and experience criteria for authorized users

• Inventory and accountability of byproduct material

3. The NRC should permit broad scope licensees to make changes in their radiation safety programs similar to those authorized for irradiator and nuclear power licensees. This adds flexibility to the license, makes allowance for growth and change, and reduces the resources expended by the NRC and the licensee in maintaining the license up-to-date.

4. The risks from internal exposure should not be considered separately from the risks from external exposure. This issue is addressed by the NRC in the requirements of IO CFR Part 20, and is implemented by licensees in their individual radiation protection programs.

Additional rulemaking would add paperwork to licensee programs, but it is not clear who would benefit.

Thank you again for providing Abbott Laboratories with the opportunity to comment.

- Sincerely yours,

DOCKETED THE ROCKEFELLER UNIVERSITY USNRC 1230 YORK AVENUE . NEW YORK, NEW YORK 10021-6399 Office of Laboratory Safety '97 FEB 12 P2 :Ql OFFICE Of SECRETARY DOCKET UMBER DOCKETIN G & SFR. 'ICE February 10, 1997 PROPOSED RULE PR 33 BRM1CH Secretary

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Nuclear Regulatory Commission Washington, DC 20555-0001 attn: Docketing and Service Branch Re: Proposed changes to 10 CFR Part 33 "Specific Domestic Licenses of Broad Scope for Byproduct Material

Dear Secretary:

We are submitting comments in accordance with the instructions provided in the Federal Register (61(221):58346) regarding proposed changes to regulations governing specific licenses of broad scope. We draw upon the experience and knowledge gained during development and oversight of a broad scope license program at The Rockefeller University but our comments represent solely our own personal and professional opinions and should not be construed to be that of The Rockefeller University.

In general we agree with and applaud what seems to be an increased emphasis on licensee-defined performance standards over a prescriptive approach. Because we see this underlying philosophical change as an improvement to the regulations, we question the advisability of some of the proposed changes and offer comments on the following "General Considerations:"

1. Should the Responsibilities ofLicensee Management for the Radiation Safety Program Be Specified in Part 33?

While there should be a clear statement from senior officials that the RSO and RSC are empowered to develop, audit, revise and enforce the licensee's radiation protection program, it should be left to the discretion of the licensee to define the internal management structure and flow of authority. The description under the Regulatory Guide 10.5 is adequate as guidance in how to develop the RSC and RSO roles. The language used under the proposed Part 33 developed in conjunction with the State of Illinois is problematic and unrealistic, especially "membership shall consist of .... at least one user authorized by the RSC from each of the departments, groups, or activities that will use byproduct materials permitted by the license." In a large institution this might mean 50-1 FEB 1 3 1997

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2. Should the NRC Incorporate Requirements for the Duties and Responsibilities of the RSO and the RSC?

The NRC should not delineate specific educational and work experience requirements for the RSO beyond the requirement that the RSO have sufficient qualifications to oversee and manage the radiation protection program as defined in the license. Setting criteria of specific educational areas and specific terms of work experience will not necessarily result in having the best qualified individual for the position nor the most benefits for the users and public. In fact, doing so may preclude appointing the most suitable individual as the RSO, may unnecessarily limit the radioisotopes used, or impose undue economical burdens to small licensees (Type B and C).

3. Should Specific Minimum Training and Experience Criteria for Authorized Users Be Incorporated Into Part 33?

The specific minimum training requirements listed in Sec. 33.15 (b)(l) and (2) are reasonable and include references to the specific scope and use of the license.

Establishing similar training requirements 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.

4. Should the NRC Incorporate Specific Requirements for Inventory and Accountability of Byproduct Material in Use, or Modify its Existing Guidance?

The existing regulations are adequate in addressing security and accountability issues surrounding use of byproduct material. The security and accountability measures should be in accordance with the small amount of materials used under these licenses. Steps beyond locking stock vials that individually contain an activity level greater than one ALI do not seem necessary. For a more detailed discussion on this subject, see K.J. Schlager et al., Consensus Radiation Protection Practices for Academic Research Institutions, Health Physics, 1996, 71(6): 960-965.

5. Should the NRC Consider the Risks Associated with Internal Exposure Pathways (e.g.,

Ingestion, Inhalation, Absorption) Separate From Those Associated With External Radiation?

Part 20 addresses internal and external exposures adequately.

6. Are There Other Specific Aspects of the Draft Regulatory Guide DG-0005 That Should Be Codified in Part 33?

The Guide should not be incorporated into the Code in order to allow flexibility in addressing the different needs and situations of each licensee. The Guide, as its name indicates, should be only a guide to help in the development of a program, but the program may deviate from the Guide and be performance-based.

2

7. Should Broad Scope Licensees Be Allowed To Make Changes in Their Radiation Safety Program Similar to Those Authorizedfor Production and Utilization Facilities in Sec. 50.59?

Yes, it would reduce paperwork and save resources for those items that truly have safety impacts.

8. Should the Different Types of Broad Scope Licensees Currently in Part 33 (I'ypes A, B, and C) Be Deleted and Replaced with a Single Type?"

Eliminating the option of a Type B or C license for a licensee that has small scale but still broad use needs will impose an undue burden on the licensee and on the governing agency with no gain in protection for the users or the public. While the majority of broad scope licenses are Type A, this proposed change would pose a monetary and administrative burden on more than 13% of the broad scope licensees who are currently TypeB orC.

9. Should the Category for "Master Materials Licenses " Be Incorporated Into Part 33 With the Respective Necessary Requirements?

Would this be useful for licensees other than federal organizations? Would it be useful to licensees that answer to different jurisdictions?

10. Should Requirements for "Multi-Site Facilities " Be Codified in Part 33 or Should This Be De.fined Only in 10 CFR Part 30?

Sufficient differences exist in the structure and needs between Broad Scope and Multi-Site that the regulations for the latter should remain separate as defined in 10 CFR Part 30.

11. What Balance Should Be Maintained Between a Performance-Based and a Prescriptive Approach to Regulating Broad Scope Licensees?

As stated earlier, a shift toward a performance-based approach is advisable, should improve efficiency, save resources, and may lead to improved safety. The four elements cited for structuring and guiding a performance-based approach are reasonable and achievable without undue burden.

We appreciate the chance to submit these comments. If there are questions, we can be reached at (212)327-8324.

A

~~ JLr Esmeralda Party Assistant Director Director Radiation & Biological Safety Officer Laboratory Safety & Environmental Health Laboratory Safety & Environmental Health 3

DOCKETED US NRC

'97 FEB 12 Al 1 :17 February 10, 1997 OFF ICE OF S [CRETAR t nersham Holdings, Inc.

DOCKETIN G & S EH V!C E636S. Clearbrook Drive BR .A.NC H Arlington Heigh cs, IL 60005 tel (847) 593-6300 t:c:i~egulatory Commission DOCKET NUMBER PR Washington, DC 20555-0001 PROPOSED RULE 33

(. fol FR 5834") ,,.Amersham The Health Science Group Attn: Docketing and Service Branch RE: 10 CFR Part 33 Advance Notice of Proposed Rulemaking. Federal Register, Vol. 61, No. lll, Thursday, November 14, 1996.

These comments are submitted on behalf of Amersham Holdings, Inc. Amersham is a manufacturer and world-wide distributor of radiopharmaceuticals, life science research radiochemicals, and radioactive sealed sources used in medicine and quality and safety assurance.

Amersham facilities as well as many of our customers will be affected by this proposed rule. We appreciate the opportunity to submit the following comments in response to the Advance Notice of Proposed Rulemaking published in the Federal Register on November 14, 1996.

General Comments

- It is important to continually review and update regulations in order to ensure that standards are clearly communicated and are consistent with most recent recommendations of nationally and internationally recognized organizations. However, care must be taken to avoid wide sweeping changes solely resulting from reactions to relatively isolated circumstances, especially when those changes may present a significant burden to licensees who are already managing an effective program.

In general, we agree with NRC's proposal to amend 10 CFR Part 33 to clarify the regulations governing specific licenses of broad scope for byproduct 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 licensees. 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 less prescriptive wherever possible. Performance based standards would empower the licensee to continually develop improved methods of managing their radiation safety programs based on their own needs.

FEB 1 3 1997

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The specific requirements of each licensee should continue to be reviewed when the license application is submitted, ensuring that the commitments made in the application are commensurate with the proposed licensed activity.

The training and experience requirements for the Radiation Safety Officer, qualification of authorized users, and the specific responsibilities of the management staff should also be reviewed taking into account the scope of the individual operation for each licensee.

To facilitate timely review of applications and lessen the burden on NRC Licensing staff, prescriptive requirements that are already acceptable to NRC staff could be presented in NRC Regulatory Guides. It would then be up to the individual licensee to decide to incorporate those requirements or develop their own for NRC review.

Comments on specific sections of the proposed rule document follow:

II. General Considerations

1. Should the Responsibilities ofLicensee Management for the Radiation Safety Program Be Specified in Part 33?

The overall responsibility of any licensee is to maintain an effective radiation safety program. Considering the variability of licensed activities covered under a broad scope license, each institution should have the flexibility to describe the responsibilities and commitments for the management of their specific program. A sample statement of responsibilities, already deemed acceptable to NRC, may be included in a regulatory guide for use by licensees.

2. Should the NRC Incorporate Requirements for the Duties and Responsibilities of the RSO and the RSC?

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.

3. Should Specific Minimum Training and Experience Criteria for Authorized Users Be Incorporated Into Part 33?

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 ofbyproduct material within an organization). Minimum requirements could be addressed in guidance documents but, ultimately, the specific requirements for these users are better determined by the RSO and RSC.

4. Should the NRC Incorporate Specific Requirements for Inventory and Accountability of Byproduct Material in Use, or Modify Its Existing Guidance?

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.

5. Should the NRC Consider the Risks Associated With Internal Exposure Pathways (e.g.,

Ingestion, Inhalation, Absorption) Separate From Those Associated With External Radiation?

The risks associated with both internal and external radiation and application of a Total Effective Dose Equivalent limit as is specified in 10 CFR 20 is consistent with ICRP recommendations and the overall philosophy of maintaining exposures and risk as low as reasonably achievable. It is unnecessary to consider the risks from internal pathways separately, and could be counterproductive if licensees are compelled to devote more of their resources toward minimizing one type of exposure at the expense of another. NRC should ensure that a licensee's program is adequate for determining dose from internally deposited radionuclides, but the management of the dose and associated limits should be consistent with those already specified in 10 CFR Part 20.

6. Are there Other Aspects of the Draft Regulatory Guide DG-0005 That Should Be Codified in Part 33?

Regulatory guides should contain information, policy statements and procedures that are acceptable to NRC which may be utilized by licensees in the development of their license application. Codifying parts of the regulatory guide could significantly reduce the flexibility of a broad scope licensee to develop the most effective methods for maintaining their programs. Part 33 should only contain performance based standards to be met by licensees, with model procedures incorporated into the regulatory guide for consideration by an applicant.

7. Should Broad Scope Licensees Be Allowed To Make Changes in Their Radiation Safety Program Similar to Those Authorized/or Production and Utilization Facilities in Part 50.59?

The level of expertise involved in maintaining a broad scope license should enable a significant amount of flexibility 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's 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.

Commensurate with the level of expertise demonstrated by broad scope licensees and the technical complexity of licensed operations, licensees should be empowered to make changes in accordance with approved QA and radiation protection programs.

8. Should the Different Types ofBroad Scope Licenses Cu"ently in Part 33 (Types A, B, and CJ Be Deleted and Replaced With a Single Type?

Different types of broad scope licenses would not be necessary ifNRC reviewed each application for requirements that are appropriate for the scope of the proposed operation.

If maintaining different types of broad scope licenses somehow lessens the burden on NRC for reviewing these applications, then they could be maintained with little impact on the overall effectiveness of the regulations, as long as types B and C licenses are not expected to maintain as comprehensive a program as that required for Type A licenses.

9. Should a Category for Master Materials Licenses" Be Incorporated Into Part 33 With Respective Necessary Requirements?

It would seem unnecessary to incorporate a "Master 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 basis with the review of requirements based on the overall scope of the proposed activity.

JO. Should Requirements/or Multi-Site Facilities" Be Codified in Part 33 or Should This Be Defined Only in JO CFR Part 30?

Refer to comments in Item Number 9.

11. What Balance Should Be Maintained Between a Performance-Based and a Prescriptive Approach to Regulating Broad Scope Licenses?

As stated previously, NRC should keep requirements for broad scope licenses as performance-based as possible. Prescriptive requirements related to ensuring safety are already incorporated into the standards set in other parts of the regulations such as 10 CFR 19, 20, and 71. Broad scope licensees should be provided with the flexibility to develop and establish their programs to meet these standards in the most effective manner considering the scope of the activity covered under the license. The establishment of a performance based approach should not necessarily be limited to those whose failure will not have an intolerable outcome since failure to meet a performance-based standard could be addressed the same as a failure to meet any other standard, prescriptive or otherwise.

IV. Specific Examples of Possible Regulatory Language The following comments apply to specific sections of the proposed language.

§33.21 (b) The minimum training requirements for the Radiation Safety Officer are good recommendations, but this section should include a provision for flexibility based on the scope of licensed activity. In addition, there should be some provision for accepting extensive work experience in lieu of an academic degree, even if it is to be approved on a case-by-case basis by NRC.

§33.22 (a)(l) The RSC membership should include a provision for broad scope licensees with small management organizations in which all managers are authorized users.

§33.22(a)(4) There should be a provision for the management's representative and RSO to send a qualified designee in their place if one or both are not available due to unforseen circumstances.

§33.59(b)(2) The requirement to submit a report within 30 days of any effective date of a change authorized in this section is unnecessarily burdensome. Changes that are authorized by the RSO and RSC under this section need only be maintained for review during an inspection or submitted as a specific request by the NRC. NRC notification and approval prior to implementation of significant changes are appropriately covered in

§33.59(c).

Thank you for your consideration of these comments. We at Amersham look forward to NRC' s development and implementation of effective broad scope license regulations.

Sincerely, Wayne London, CHP Manager, Nuclear Regulatory Affairs

DOCKETED PHARMACIA & UPJOHN , INC. USNRC 301 Henrietta Street Kalamazoo,MI 49007 License No. 21-000182-0 "97 f£B 12 Al1 :15 FFICE Of SEC~~I AP~Y_

DOCKET NUMBER Lawrence J. Ke li< [ J\NG & 'SEh 'i \(,, _

PROPOSED RULE PR 33 Manager, Labor 7264-025-031

'naa11! 1/4~ ~W?~~rt

((pf~(<_ 58'3 4to) Telephone No. (616) 833-9383 Fax. No.: (616) 833-9400 February 4, 1997 Secretary ,

Nuclear Regulatory Commission Attn: Docketing and Service Branch Washington, DC 20555-0001

Dear Secretary,

The following comments are made in response to the proposed changes to 10 CFR ,

Part 33, published in the Federal Register, Vol. 61, No. 221, dated November 14, 1996.

Much of the proposed rule appears to be rooted in observations made by the NRC during the investigation of two situations where there was an intake of radioactive material by a radiation worker. It is our opinion these intakes were isolated cases and a situation where there was criminal intent on the part of a particular individual(s). Most, if not all, of the proposed rule appears to be a knee-jerk reaction to these two isolated cases . It is our view that, short of abolishing the use of byproduct material, no one can write a regulation that will preclude a criminal act. The NRC' s reaction threatens the flexibility that licensee and NRC personnel currently have, to be able to tailor a license to meet specific operational needs. We believe most, if not all, of the proposed rule is unnecessary as most broad scope licensees have many of these provisions already included in their license.

Be that as it may, Pharmacia & Upjohn has performed an evaluation of the proposed rules and with respect to your request for comments on general considerations, the following is submitted:

1. NRC Question #1, #2 and #3 - Should the responsibilities of licensee management for the radiation safety program be specified in Part 33 and, should specific minimum training and experience criteria for authorized users be incorporated into Part 33 ?

P&U Response - Guidance that defines, 1) management responsibilities for oversight of radiation safety programs, 2) responsibilities of the RSO, 3) responsibilities for the radiation safety committee, 4) training requirements for the RSO, and 5) training requirements for users and supervised individuals, should be provided in a Regulatory Guide as is current practice. We do not believe that incorporating detailed requirements in Part 33 is of value as this

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Secretary, NRC Page 2 approach usually results in excessive regulatory burden on licensees.

Regulations that endorse regulatory guides allow judgement and flexibility to be applied during the licensing process.

2 NRC Question #4 - Should the NRC incorporate specific requirements for inventory and accountability of byproduct material in use, or modify its existing guidance?

P &U Response - Current regulation and guidance on the inventory and accountability of byproduct material is 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 two people, may unnecessarily burden many other licensees who have demonstrated good performance.

3. NRC Question #5 - Should the NRC consider the risks associated with internal exposure pathways separate from those associated with external radiation?

P &U Re spon se - The methodology used in 10 CFR, Part 20 should be used for estimating internal exposure.

4. NRC Questions #6 - Are there other specific aspects of the draft Regulatory Guide DG-005 that should be codified in Part 33?

P&U Response - As noted in 1 above, all detailed guidance to meet radiation safety objectives should be provided via Regulatory Guides. The guidance provided in RG DG-0005 should not be codified but referenced in the regulations.

5. NRC 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 50. 59?

P&U Response - Pharmacia & Upjohn applauds the idea of allowing the Radiation Safety Committee the ability to "make changes to the facility or procedures as described in the license application", "without prior commission approval". However, the proposed wording of 33.59 (a), which reads, "unless the proposed change involves a change in a specific license condition", seems to dull or completely nullify the potential benefits that could be realized from this philosophy. It is suggested the wording of 33.59 (a) be revised to allow the RSC to make changes to the license (with subsequent notification to the NRC) as long as it is not in a "less conservative direction" than the existing condition.

6. NRC Question #8 - Should the different types of broad scope licenses currently in Part 33 be deleted and replaced with a single type?

P&U Response - It appears prudent that the NRC take steps to change the licensing classification system from Type A, B and C broad scope to "specific license of limited/broad scope".

Secretary, NRC Page 3

7. NRC Question #9 - Should a category for "Master Materials Licenses" be incorporated into Part 33 with the respective necessary requirements?

P&U Response - 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 license" philosophy should be codified.

8. NRC Question #JO - Should requirements for "Multi-Site Facilities" be codified in Part 33 or should this be defined only in Part 30?

P&U Response - It appears that the regulations covering a multi-site license will be in addition to those specified in 10 CFR 33, under the type "specific licenses of broad scope". As such, the requirements for multi-site licenses should be included in this part.

9. NR C Question #11 - What balance should be maintained between a performance-based and a prescriptive approach to regulating broad scope licensees?

P&U Response - We believe that regulation and guidance should always be "performance based". Regulations should be written, and regulators should be operating, in a manner which allows licensees maximum flexibility in order to meet program objectives in a cost effective manner.

As an example, the proposed rule requires the licensee to have a written procedure for "receiving and safely opening packages of byproduct material" which must be "reviewed and approved by the radiation safety committee" (33.12 (h)). As long as written procedures are in place which accomplish the objective (in this case, receive and safety open packages), it may not be efficient, nor cost effective, to have each member of the radiation safety committee review and approve the procedure.

All proposed rules should be reviewed with this example in mind.

With respect to specific sections of the proposed changes to 10 CFR, Part 33, Pharmacia & Upjohn provides the following comments:

1. Section 33.2 -

The last part of the sentence which defines the Radiation Safety Committee is redundant. It is suggested that the words "including responsibility for approval of all proposals for radionuclide use and users" be eliminated as this responsibility is fully defined in 33.22(4)(b)(2).

2. Section 33.12 (h) -

A "performance based" approach would allow licensee management to determine if it was necessary for the radiation safety committee to "review and approve" written procedures. It is suggested that a requirement for such not be codified.

Secretary, NRC Page 4

3. Section 33.17 (b)(2) -

Pharmacia & Upjohn does not use byproduct material for "medical use" and therefore, is not regulated by 10 CFR 35. However, Pharmacia & Upjohn (as well as other pharmaceutical companies) does use byproduc_t material for "human research" in accordance with 21 CFR, Part 361, where the amount of byproduct material is minute compared to normal therapeutic or diagnostic dose. 21 CFR 361, which is the Food and Drug Administration's regulations governing the use of radioactive material in human research, has specific requirements which provide adequate controls over this research involving humans, i.e.; oversight by a Radioactive Drug Research Committee and an Institutional Review Board. To avoid confusion, and differentiate between "human research" and "medical use", it is strongly recommended that 33.17 (b) be modified to recognize "human research" as conducted by the pharmaceutical industry and reference the provisions of 21 CFR 361, while avoiding all reference to 10 CFR 35.

4. Section 33.22 (a)(l) -

The term "medical broad scope licensees" is inconsistent with the previous proposed types of licenses defined in 33.11. To keep terminology correct, this might better be phrased "specific broad scope licenses for medical use".

5. Reporting requirements -

There appear to be some redundancies with regards to internal radiation safety program reviews and reports. Specifically, 33.21(c)(3), 33.22(b)(3),

33.22(b)(l) and 20.1101 all refer to a need to provide an annual review/report covering the same issues. It is suggested that the intent be clarified and the redundancies eliminated.

It is requested that these comments be addressed as part of the comment resolution for the proposed rule for 10 CFR 33.

Sincerely, PHARMACIA & UPJOHN, INC .

LJKelSh~

Radiation Safety Officer - PPC-US ljk/cmk cc : cws WGA

Environmental Health & Safety UJ WYOMiNG DOCKETED USNRC P.O. Box 3413 Room 312, Merica Hall Laramie, Wyoming 82071-3413 (307) 766-3277 "97 FEB 12 Al1 :15 OFFICE OF SECRE TA RY OOCKETIHG & SERVICE BRANCH January 21, 1997 DOCKET NUMBER PROPOSED RULE PR 33 Secretary ( (o/ F!<.5'63'-/-lo)

Nuclear Regulatory Commission Washington, DC 20555-0001 Attn: Docketing and Services Branch

DearNRC:

Enclosed are comments made by individuals from the University of Wyoming Environmental Health and Safety Office. Specifically, these are answers to the questions posed in the Federal Register on November 14, 1996, regarding the codification of regulations governing specific licenses of broad scope for byproduct materials. If you require clarification on any of the comments, feel free to call at (307) 766-3277.

Sincerely, Jim Herrold Assistant Manager, EHS FEB 1 3 1997

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Comments from Jim Herrold, Assistant Manager, EHS / Radiation Safety Officer:

Because my answers to questions 1 through 8 are primarily based on my response to question 11, I will answer that one first.

11. What Balance Should Be Maintained Between a Performance-Based and a Prescriptive Approach to Regulating Broad-Scope Licensees?

It is preferable to leave the codified regulations flexible in order to accommodate the myriad of situations for which a broad-scope license may be needed. No matter how carefully they may be written, there will always be situations where a particular segment of the regulations does not make sense for a particular licensee. When an application for a broad-scope license is submitted it is based on realistic expectations of the scope of the individual radiation safety program. Once accepted by the NRC, the license becomes the set of regulations that the licensee must follow and upon which it will be inspected.

Instead of casting the program parameters as regulations, it is better to offer them as professional guidelines (such as Regulatory Guides or NUREGS) which can contain more detail in order to be used as models for an acceptable program. This allows the prospective licensee to negotiate realistic methodologies with the regional NRC office.

This is the beauty of the NRC regulatory system as it stands now. It is the process of submitting an application and negotiating with the NRC Licensing Branch that forces the prospective licensee management, RSC, RSO to work together. This promotes better awareness of the radiation safety program and cooperation with the NRC.

The problem of licensees being unaware of NRC requirements will not be solved by adding more bulk to the regulations. The real problem is that licensees are unaware of what is required under existing regulations and in their own licenses. This problem has been compounded during the renewal of licenses by the practice of incorporating all previous licenses, letters, amendments, manuals, etc. into the new license, making the license a mountainous volume of incongruent paperwork. Licensees should be required to re-file a complete, orderly copy of the renewed license on a regular basis. This would enhance license comprehension and usefulness, for both the licensee and the NRC. New and renewed licenses should have a signature page certifying the full awareness and cooperation of the RSO, Radiation Safety Committee and management.

I agree with the NRC staff that a risk-informed, performance-based regulatory approach should contain the elements of measurability and objectivity. These factors do not necessarily have to be written into the regulations, but can easily be described in the individual license. 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 actually being met in the manner intended. If programs with limited budgets are directed to follow rules that do not take actual risks into account, their only choices are to either sacrifice other more serious safety concerns or be out of compliance with the regulations.

2

Jim Herrold's comments, continued:

1. Should the Responsibilities ofLicensee Management for the Radiation Safety Program Be Specified in part 3 3?

The specific responsibilities 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 statements regarding management at both of these types of businesses ignores their differences and disallows any flexibility in creating effective radiation safety programs. If anything at all should appear 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.

2. Should the NRC incorporate Requirements for the Duties and Responsibilities of the RSO and the RSC?

No. For the same reasons mentioned in question 1 above, this is a bad idea. A program of twenty or forty authorized users does not require the same caliber ofRSO 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.

Requiring minimum levels of education without weighing experience and non-degree training (such as from the Navy or ORISE) discriminates against otherwise highly competent applicants. On limited budgets, licensees need options in which they can find the right person for the job at an affordable salary.

3. Should Specific Minimum Training and Experience Criteria/or Authorized Users Be Incorporated Into Part 33?

No. This would be addressed better in guidance documents. The ability to weigh the qualifications of the Authorized User (considering the isotopes, procedures, equipment and facilities for which the person is applying) is supposedly addressed under the powers of the Radiation Safety Committee. These parameters can vary greatly at one single institution. To phrase a regulation addressing qualifications for all possible users at all possible broad-scope licenses would be nearly impossible.

4. Should the NRC Incorporate Specific Requirements for Inventory and Accountability of Byproduct Material in Use, or Modify Its Existing Guidance?

This would best be handled under modified guidance documents in which more detailed suggestions could be made and more flexibility on handling the situation would be given to individual licensees. Procedures would be incorporated into individual licenses, which are equally enforceable by the NRC.

3

Jim Herrold's comments, continued:

5. Should the NRC Consider the Risks Associated With Internal Exposure Pathways Separate From Those Associated With External Radiation?

The revisions to 10 CFR 20 were based in part on recommendations by the ICRP and NCRP, after twenty years of consideration and debate. It was expensive for the government 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.

6. Are There Other Specific Aspects of the Draft Regulatory Guide DG-0005 That Should Be Codified in Part 33?

No. Make the proposed revisions to Regulatory Guide 10.5 and leave it at that.

7. Should Broad Scope Licensees Be Allowed To Make Changes in Their Radiation Safety Programs Similar to Those Authorized/or Production and Utilization Facilities in JO CFR 50.59?

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 document 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. The only purpose for the NRC requesting such a report would be so they can review the changes and deny them if they determine the changes were not within the scope of the regulations. What, then, is the purpose of the Radiation Safety Committee in this matter, and where is the advantage over how the regulations stand now? It would be better to either leave out section 33.59(b)(2) or allow individuals to request these changes in their individual license applications.

8. Should the Different Types ofBroad Scope Licenses Currently in Part 33 (Types A, B and CJ Be Deleted and Replaced with a Single Type?

In the light of the number of actual existing Types B and C licenses, this would not have much of an impact. However, the NRC should keep in mind the necessity for flexibility to allow Broad Scope licenses for programs ranging from relatively small to very large.

4

l ,. .,

Jim Herrold's comments, continued:

9. Should a Category for "Master Materials Licenses " Be Incorporated Into Part 33 With the Respective Necessary Requirements?

In some cases this might make regulating these license locations more difficult. We have USDA labs housed on our University campus, which is a common practice. These labs used to be regulated under the USDA master license. More recently, however, an agreement was made 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 radionuclide usage in these facilities much simpler.

- Comments from Richard Wilson, Assistant Supervisor, Hazardous Materials:

1. Should the responsibility of license management for the radiation safety program be specified in Part 33? (NRC is soliciting comment on the mechanism for, and the extent to which, requirements de.fining management responsibilities for oversight of radiation safety programs should be included in Part 33)

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 properly. Larger facilities will spend less time on insignificant issues thereby saving time and money.

An effective mechanism to accomplish the required management aspects of an audit program is to establish a matrix. This management matrix would have the required section of 10 CFR 33 along the left side and the periodicity along the top. Then reviews can then be assigned by the RSC to individuals as necessary to complete the audit. Audits should be accomplished by independent reviewers, i.e. people from within the organization who do not have a vested interest in the outcome of the audit. These audits should be comprehensive and only done on an annual basis. Monthly, for each audit, there must be a supporting surveillance of the attribute or some portion of the attribute being audited.

The surveillance can and should be conducted by someone who directly supervises another person involved with the activity. This can then involve the RSO in the day to day operation of the facility that is under their management authority. The surveillance can also be used as a learning tool to improve the employee training by correcting improper procedures and explaining the "why's" of specific techniques.

As a portion of this, at facilities with over 500 employees, there should be designated an Assistant Radiation Safety Officer. The scope of the RSO position is such that it is impossible for one person to be able to conduct all of the required inspection, surveillance, and management tasks required in a larger facility, this should be incorporated into the license and 10 CFR 33. By better defining the management roles and responsibilities for the oversight of radiation safety smaller institutions would benefit greatly. Often at these institutions individuals are required to "wear several hats" and at times lines of authority can become rather "fuzzy."

5

Richard Wilson's comments, continued:

2. Should the NRC incorporate requirements for the duties and responsibilities of the RSO and the RSC? (The NRC is soliciting public comments on the need/or specific requirements delineating the roles and responsibilities of the RSC and RSO and the establishment of minimum training and experience criteria for the RSO)

This could unnecessarily constrict the scope of the RSO and the RSC's function. The idea that "one size fits all" cannot be applied to industry, education and research organizations.

This would make it much more difficult for smaller institutions to maintain the necessary flexibility with more limited budgets and personnel. It also places a great deal of discretionary power in the hands of the NRC, to decide what are "necessary" qualifications and to whom they will apply.

3. Should the NRC specific minimum training and experience criteria/or authorized users be incorporated into part 33? (The NRC is soliciting comment on whether training and experience criteria should be incorporated into the regulations or be addressed in guidance documents.)

Training and experience should be established as guidance only. An increasing trend in this country is that of education via non-traditional means. In addition there are very few institutions in the country that offer curricula to train a RSO in the proper management techniques required for management of byproduct material. Simply having a degree in a scientific or engineering field is not sufficient qualification for a RSO. Certification by reputable professional organization would be more appropriate.

4. Should the NRC incorporate specific requirements for inventory and accountability of byproduct material in use, or modify its existing guidance.(The NRC is soliciting comments as to codification, in the regulation, of requirements regarding accounting/or, and inventory of radioactive materials.)

This issue must be left to the individual institutions or facilities. The adequacy of security area establishment and inventory should be reviewed by the NRC and included in the application for the broadscope license at the time of renewal.

5. Should NRC consider the risks associated with internal exposure pathways separate from those associated with external radiation? (The NRC is soliciting comments on whether the risks from internal exposure should be considered separately from the risks from external exposure.)

Considering the predominance of materials with low penetrating energies, but with high ionization constants, resulting in generally an insignificant external dose but with the potential for high internal exposures. It would be reasonable to view these exposures separately. A viable method must be developed stating the target organs and dose to activity ratios. A review of a facilities invivo and invitro program must be included in and emphasized by NRC inspections and the licensing process.

6

6. Are there any other specific aspects of the draft regulatory guide DG-0005 that should be codified in Part 33? (The NRC is soliciting comments on which, if any, aspects of the draft regulatory guidance for broad scope facilities should be codified in the regulations.)

The only addition to 10 CFR 33 should be the inclusion of internal exposure control programs as a requirement to allowing a licensee to continue operations.

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 section 50.59? (The NRC is soliciting comments on allowing broad scope licensees to have the flexibility to make changes to their radiation safety program as is afforded to irradiator and nuclear power licensees.

Yes. Broad scope licensees should have the flexibility to make procedural adjustments and program improvements without having to change or amend the broad scope license.

8. Should the different types of broad scope licenses currently in Part 33(types A, Band C) be deleted and replaced with a single type? (The NRC is soliciting comments on whether to eliminate types B and C specific licenses of broad scope.)

No. This would severely limit smaller facilities and institutions to an unnecessary set of rules which would be very costly to the institution and the government.

7

DOCKET NUMBERPR (j)

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( (pl f~ 58'3c./l) DOCKETED Comments on Advanced Notice of Proposed Rulemaking USNRC Broad Scope Licensing for Byproduct Material "97 FEB l 0 P4 :5 7 Comments on General Considerations OFFICE OF SECRETARY

1. Should of the responsibilities of licensee management for the radiation safet:t)~a5-h~ & S

• HVICE specified in part 33? 'RAN 1:l-i It may be acceptable to spell out licensee management responsibilities in part 33; however, when a license application is submitted, the individual who signs said application is basically committing the licensee to following all NRC regulations, commitments made in the application, and any license conditions. The individual signing the application should have sufficient authority to make such commitments for the licensee. Reiterating licensee management's responsibility in part 33 may be unnecessarily redundant. If licensee management responsibilities are incorporated into part 33, they should be very general.

2. Should the NRC incorporate requirements for the duties and responsibilities of the RSO and the RSC?

Given the diversity of the types of broad scope licensees, any RSO duties and responsibilities incorporated into part 33 should be very general. Specifying minimum training and experience criteria for the RSO may be difficult, particularly if the different types of broad scope licenses (e.g., Type A, B, or C) are dissolved. Obviously, the RSO for a Type A license must have considerably more training and experience than the RSO for a Type C license. If the various types of broad scope licenses are eliminated, the "minimum" training requirements for the RSO of a broad scope license might be overkill for one license and inadequate for another.

3. Should specific minimum training and experience criteria for authorized users be incorporated into part 33?

Many broad scope licenses include a considerable diversity regarding radionuclide use. Some authorized users may be handling microcurie to millicurie quantities of radioactive materials.

Others may be using self-contained irradiators. Training and experience criteria should be developed by the licensee and included as a part of the license application with appropriate justification. Licensees should also have the flexibility to adjust the training and experience requirements under certain circumstances provided that such adjustments are reviewed and approved by the RSC.

4. Should the NRC incorporate specific requirements for inventory and accountability of byproduct material in use, or modify its existing guidance?

Inventory and accountability of byproduct material should be a license specific requirement.

Licensees should be required to describe their methods of inventory and accountability of 1

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byproduct material during the licensing process. Codifying this requirement into the regulations would not appear to be advantageous over dealing with inventory and accountability during the licensing process.

5. Should the NRC consider the risks associated with internal exposure pathways separate from those associated with external radiation?

No.

6. Are there other specific aspects of the Draft Regulatory Guide DG-0005 that should be codified in part 3 3?

Codifying regulatory guide aspects into regulations should be done with considerable caution.

Prescriptive regulations are not a substitute for "good" licensing. The last major revision of 10 CFR 3 5 involved the incorporation of guidance from the medical licensing guide (Regulatory Guide 10.8) into the regulations. This caused a considerable amount of confusion, particularly for broad medical licensees. The licensee should work with the NRC during the licensing process to assure that the radiation safety program meets the regulations and can be effectively administered by the licensee. Prescriptive regulations may reduce the flexibility which a broad scope license is intended to provide.

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 sec. 50.59?

This should be allowed for large broad scope licensees (e.g., Type A) that have a radiation safety committee and/or a full time radiation safety officer. Smaller broad scope licensees that do not utilize a radiation safety committee and/or a full time radiation safety officer may not have the expertise to fully evaluate the impact of such changes.

8. Should the different types of broad scope licenses currently in part 33 (Types A, B, & C) be deleted and replaced with a single type?

There are some advantages in retaining the various types of broad scope licenses. As mentioned in previous comments, various types of requirements (e.g., RSO qualifications, RSO duties and responsibilities, program changes, etc.) can be tied to the type of license. It might be possible to reduce the number of broad license types (e.g., "limited" broad scope and "extended" broad scope).

9. Should a category for "Master Materials Licenses" be incorporated into part 33 with the respective necessary requirements?

No comment.

2

10. Should requirements for "Multi-Site Facilities" be codified in part 33 or should this be defined only in 10 CFR 30?

No comment.

11. What balance should be maintained between a performance-based and a prescriptive approach to regulating broad scope licensees?

Regulations should be predominately performance-based for large, broad scope licensees. These types of licensees typically require professionally trained health physicists, adequate technical support staff, and some type of committee oversight to administer the radiation safety program.

Prescriptive based regulations should be minimized for such licensees that include these key components. Furthermore, extensive prescriptive regulations may result in increased numbers of requests for exemptions to said regulations and may defeat the purpose of the broad scope license.

Comments on Proposed Part 33 Language Sec. 33.2 Definitions - Add the following definition:

Radiation worker means an individual receiving, possessing, or using byproduct material under the supervision of an authorized user.

Sec. 33.11 Types of specific licenses of broad scope - Retain Type A, Type B, and Type C licenses with the current descriptions of each.

Sec. 33.12 Applications/or license, amendment, or renewal- Items (b) and (c) under this section imply that a broad scope license will only be issued if the applicant has had a previous license of limited scope and based upon previous regulatory compliance. Although unlikely, it is possible that an applicant would apply for a broad scope license initially (i.e., would not have a limited scope license before the application). Items (b) and (c) should be deleted.

If the different types of licenses is retained (e.g., Type A, B, or C) as suggested above, item (e) would only apply to a Type A license. Item (e) should be changed accordingly.

Item (h){l0) implies that anyone working in or frequenting areas where byproduct material is used or stored would have to be trained. This is in direct conflict with the requirements of 10 CFR 19.12. The word personnel should be changed to authorized user or radiation worker in item (h){lO).

In item (h){l l), it appears that the words users and uses are reversed in the context of the sentence. It should be revised to read, "(] 1) Conducting radiation safety evaluations ofproposed authorized uses of byproduct material, including training and experience ofproposed users;"

3

Item (h)(12) is redundant with the first part of item (h)(l 1). The review of facilities and equipment should be incorporated into item (h)(l 1) or item (h)(12) should be revised to read,

"{l 2) Evaluating the facilities and equipment where byproduct material is to be utilized and stored;"

Sec. 33.17 Requirements of specific licenses of broad scope - Item (b)(2) restricts the use of byproduct material in humans (medical use as defined in 10 CFR 35) to individuals who meet the training requirements of 10 CFR 35.900 through 10 CFR 35.981. There is no reason why physicians who do not necessarily meet the requirements of those sections cannot perform human use research studies with byproduct material. For example, human tracer studies utilizing microcurie quantities of a 14C labeled compound could be done by a physician with specific training in such activities which may not be as restrictive as that referenced in 10 CFR 35. The following sentence should be added to (b)(2) of this section: Licensees who authorize the use of small quantities of byproduct material in humans for research purposes must submit training and experience criteria in the license application for physicians who wish to conduct such research if said physicians do not meet the training criteria in JO CFR 35.900 through JO CFR 35.981."

Sec. 33.22 Radiation Safety Committee - The NRC typically requires licensees to list the names of their Radiation Safety Committee members in their license application which is incorporated into the license by reference. There are some circumstances where a committee member might not be able to attend a scheduled meeting (e.g., sickness, sabbatical leave, etc.). This may affect the ability of the committee to hold a scheduled meeting due to quorum or other attendance requirements. Rescheduling a meeting under such circumstances is unnecessarily cumbersome.

To alleviate this problem, an additional item (e.g., item (a)(5)) should be added to this section as follows: "(5) With the exception of the RSO or the committee chairman, any committee member may temporarily appoint a replacement to attend a scheduled committee meeting with the approval of the committee chairman. Such replacements shall be specifically noted in the committee meeting minutes.

Sec. 33.25 Supervision -As noted in a previous comment, the term "radiation worker was defined as an individual working under the supervision of an "authorized user. In this section, references to "individuals" or "supervised individuals" should be replaced with the term "radiation worker".

Sec. 33.59 Radiation safety program changes - Item (b)(l) is too prescriptive with respect to the documentation of changes to the radiation safety program. For Type A licenses (assuming the different types are retained), any radiation safety program changes should be reviewed and approved by the Radiation Safety Committee (RSC). Documentation of such changes should be documented in the RSC meeting minutes. It is recommended item (b) of this section be changed as follows:

4

"(b) The licensee shall maintain records of changes in the facility and of changes in procedures made pursuant to this section until the license has been renewed or terminated Such records shall include:

(1) For broad scope licensees with a Radiation Safety Committee (RSC), the changes shall be documented in the RSC meeting minutes, signed by the RSC chairman. Such documentation shall be of sufficient detail to establish the nature of the change and the justification for same; (2) For broad scope licensees that are not required to establish a RSC, the changes shall be described in a written document, signed by the RSO and a management representative. The information shall be in sufficient detail to establish the nature of the change and the justification for same.

Item (b)(2) of this section requires that a report be submitted within 30 days of making changes under this section. It does not specified to whom such a report is to be submitted. It appears that the report is supposed to be submitted to the NRC. If that is the case, this requirement is not consistent with the "ministerial" changes authorized under 10 CFR 3 5. 31 (i.e., medical licensees are not required to report ministerial changes). Broad scope licensees are probably more qualified to make these changes; therefore, requiring reporting of such changes ( at least those that are ministerial in nature) seems too restrictive. Perhaps the proposed rule needs to be expanded to include the types of changes for which a report to the NRC is required (or not required).

General Comments It appears that one of the primary reasons for this proposed rule change is related to the recent incidents involving ingestion of byproduct material. Based upon a review of these incidents, there was some speculation that malicious intent was involved. It should be pointed out that no amount of regulation can eliminate malicious acts. Rather than change the regulations, a better approach may be to place additional emphasis on certain aspects of broad scope licensee programs during the licensing process. Broad scope licenses are designed to provide flexibility and minimize the administrative burdens on both the licensee and the NRC for licensees who can demonstrate adequate administrative and technical control of their radiation safety programs. Any changes in the regulations should certainly be performance based rather than prescriptive to prevent undermining the intent of the broad scope license.

~,uL .

MackL. Richard, M.S.

INDIANA UNIVERSITY PUROOE UNIVERSITY Clinical Building 159 541 Clinical Drive Indianapolis, Indiana INDIANAPOUS Radiation Safety Officer 46202-511 l Indiana University Medical Center 5 RADIATION SAFETY OFFICF.

0 DOCKETED USN RC Council on Radionuclides and Radiopharmaceuticals, Inc.

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3911 Campolindo Drive Moraga, CA 9455~1551 "97 FEB 10 P4 :57 510/283-1850 Fax: 510/283-1850 Henry H. Kramer, Ph.D., FACNP OFFICE OF SECRETARY February 4, 1997 Executive Diucwr DOCKETING &. SERVICE BRANCH Secretary Nuclear Regulatory Commission DOCKET NUMBER PROPOSED RULE p R 33 Washington, DC 20555-0001

( (pl F~ 5~3t./&,)

Attention: Docketing and Service Branch

References:

Federal Register, Vol. 61, No. 221, November 14, 1996 Proposed Rule:

Specific Domestic Licenses of Broad Scope for By-Product Material.

Federal Register, Vol. 59, No. 212, November 3, 1994 NRC Draft Regulatory Guide DG-0005 Applications for Licenses of Broad Scope.

These comments are submitted on behalf of the Council on Radionuclides and Radiopharmaceuticals (CORAR). CORAR members include the major manufacturers and distributors of radiopharmaceuticals, radioactive sources and research radionuclides used in the U.S. for therapeutic and diagnostic medical applications and for industrial, environmental and biomedical research and quality control. CORAR members are U.S. NRC or Agreement State broad scope licensees and are therefore affected by this proposed rule. The main concern here is that NRC is proposing to prescribe how licensees are to structure their organization and how to design duties and responsibilities within the organization. CORAR maintains that such suggestions should be presented in a Regulatory Guide, as examples of how to organize a radiation protection program, rather than in a regulation. CORAR has attached detailed comments on this proposed rule and has the following general comments:

1. Regulations for broad scope licensees should be performance based.

2. Prescriptive requirements should be avoided in the regulations, and when necessary, applied on a case by case basis as license conditions.

3. Most of the prescriptive requirements in this proposed rule would be more effectively conveyed to licensees in a Regulatory Guide if presented as examples of acceptable ways to structure a radiation protection program.

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4. It is impractical for any regulatory agency to prescribe organization structure and specific duties and responsibilities for the great range of broad scope licensee practices and conditions.

5. Broad scope licensees have access to sufficient expertise and resources to enable them to make their own decisions on developing and maintaining a radiation protection program and should be given the authority to do this to meet regulatory performance standards.

6. 10 CFR 33 should include a section that specifically permits licensees to define their own radiation protection program and related organization, responsibilities and duties in the license application to meet regulatory requirements .

• 7. Broad scope licensees should be allowed to make timely and appropriate improvements to their radiation protection program and related information described in license applications without the delays and burden of intensive documentation and NRC notifications and approvals.

8. CORAR is concerned that the proposed rule is: (1) too prescriptive and is often counterproductive for major manufacturing licensees, and (2) has content that would serve the licensee, the regulator and the public more effectively if reshaped and issued as guidance rather than regulation.

CORAR appreciates the opportunity to comment on this proposed rule and would be glad to provide further information or clarification.

Sincerely yours, Leonard R Smith, CORAR Vice Chairman 2

214197 CORAR COMMENTS ON PROPOSED RULE: SPECIFIC DOMESTIC LICENSES OF BROAD SCOPE FOR BYPRODUCT MATERIAL AND DRAFf REGULATORY GUIDE DG-0005.

1. Page 58346, column 3, paragraph 1,

SUMMARY

"Currently, the regulations do not contain a clear description of the duties and responsibilities of management, the Radiation Safety Officer (RSO) or the Radiation Safety Committee (RSC)."

CORAR agrees with the NRC intent that licensee management, RSO and RSC responsibilities and duties with respect to the control of licensed material should be clear.

However, we maintain that it is impracticable for the NRC to prescribe these duties and responsibilities in the regulations. It is infeasible that a set of duties and responsibilities can be established that would be applicable to all broad scope licensees.

Instead of defining duties and responsibilities in the regulations, the NRC should require licensees to do this. The NRC should consider providing examples of acceptable ways to implement these responsibilities in a regulatory guide. By this approach NRC can avoid being prescriptive and licensees will have the flexibility to optimize their radiation protection programs.

2* Page 58347, column 3, paragraph 3, lines 7 to 10:

"... from 1993-96 there were only 38 events involving these licenses that resulted in some type of enforcement action."

An important point that was not stated is that actual doses to members of the public were negligible. It appears from this result that controls are adequate and that there is little need for further regulatory controls.

1

3. Page 58348, column 1, paragraph 3, lines 9-14:

"Although Part 33 requires the establishment of an RSC and the appointment of an RSO, it does not provide broad scope licensees with a clear description of the duties and responsibilities of the RSO or the RSC."

It is not necessary or even appropriate to define RSO and RSC duties and responsibilities in 10 CFR 33. This would be too prescriptive. Any one set of duties and responsibilities is unlikely to be appropriate for all licensees. NRC has full authority to require licensees to clarify duties and responsibilities in the license application. If NRC thinks that licensees need guidance in determining duties and responsibilities this guidance should be provided in a regulatory guide. The guidance should be flexible in full recognition of the extreme range of conditions and practices at licensee site.

4. Page 58348, column 2, paragraph 4:

"1. Should the Responsibilities of Licensee Management for the Radiation Safety Program Be Specified in Part 33?"

CORAR recommends that overall program objectives should be specified in 10 CFR 33 and that guidance on licensee management be provided in Regulatory Guide 10.5.

5. Page 58348, column 3, paragraph 2:

"2. Should the NRC Incorporate Requirements for the Duties and Responsibilities of the RSO and the RSC? [in 10 CFR 33] ".

CORAR recommends that overall program objective should be specified in 10 CFR 33 and that guidance on RSO and RSC qualifications, duties and responsibilities be provided in Regulatory Guide 10.5.

6. Page 58348, column 3, paragraph 4:

"3. Should Specific Minimum Training and Experience Criteria for Authorized Users Be Incorporated Into Part 33?"

CORAR contends that it is not practicable to specify training and experience criteria in 10 CFR 33 that would be appropriate for all licensees.

Instead, CORAR recommends that the NRC provides guidance on qualifications for key personnel in Regulatory Guide 10.5.

2

7. Page 5834, column 1, paragraph 2:

"4. Should the NRC Incorporate Specific Requirements for Inventory and Accountability of Byproduct Material in Use, or Modify its Existing Guidance?

CORAR participated in the NRC Region I Workshop on Security and Control of Licensed Materials. The general consensus at this meeting was that NRC needs to define a level where a formal program for the control and security of licensed material would be required. Guidance or actual requirements could most usefully be conveyed in a Regulatory Guide or specified as a license condition on a case by case basis. Inventory control of sealed sources should be specified as a license condition as is current practice. The consensus at the NRC Workshop was that formal security and control measures should be considered when possession of unsealed licensed material exceeds one Annual Limit on Intake or one hundred times the quantities specified in 10 CFR 20 Appendix C. A higher limit should be specified for sealed sources. Licensees should also be able to demonstrate control of smaller quantities of licensed material, but the requirements should be no more restrictive than those applying to the control of chemicals commonly present in the research laboratory.

8. Page 58349, column 1, paragraph 4:

"5. Should the NRC Consider the Risks Associated With Internal Exposure Pathways ... Separate From Those Associated With External Radiation?"

The current NRC practice for considering risk from internal and external exposure is compatible with recommendations of the National Council on Radiation Protection and Measurements and the International Commission Radiological Protection. This current practice is appropriate because the risk from committed effective dose from internal exposure is defined to be generally equivalent to the risk from a similar external dose. Hence there is no need for a separate nor different internal or external dose limit and CORAR agrees with the present radiation standard.

However, because there is a difference in the way individuals are exposed to internal and external radiation, it is necessary that licensees have different procedures for controlling these exposure pathways. As a consequence it would be very difficult for regulators to prescribe appropriate control procedures since these will differ considerably for different licensees. In practice, licensees 3

generally apply more restrictive controls on operations that can produce internal exposure. 1bis is in recognition that internal exposure is often more difficult to monitor, internal dose estimates less accurate than external and because employees perceive internal exposure to be less acceptable than external.

Consequently, the current practice is for licensees to apply stricter controls on internal exposure. Licensees should be allowed to continue to apply controls that are appropriate to the conditions and practices they encounter.

9. Page 58349, column 1, paragraph 6:

"6. Are There Other Specific Aspects of the Draft Regulatory Guide DG-0005 That Should be Codified in Part 33?"

CORAR does not recommend that any guidance in Draft Regulatory Guide DG-0005 be codified in 10 CFR 33. CORAR believes 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.

CORAR also has concerns with Draft Regulatory Guide DG-0005. The main concern is that DG-0005 is too prescriptive. CORAR members have had direct experience with the recommendations in DG-0005 and found some of them to be unworkable. For example, CORAR maintains that licensee management has ultimate responsibility for establishing policies and procedures and the RSC serves best in a review and advisory capacity. Generally, in an organization where there is a need for effective action, there should be an individual who is held accountable for completing the action. For important actions, such as maintaining a radiation protection program, that individual needs to be high in the organization, i.e. needs to be a manager.

In large manufacturing programs, we have observed that a designated Radiation Protection Officer cannot also serve as RSC chairperson or manage the whole radiation protection program. It is very rare that an individual will have both the management experience and maintain the technical expertise necessary to combine both functions. In large manufacturing facilities the most successful arrangement is to provide a management organization for those who use the licensed material with the plant manager having ultimate responsibility. This enables the Radiation Protection Officer to be free to apply their specific radiological skills that are necessary for a successful program. The RPO will often supervise a Radiation Protection Support Group who have specific audit and service responsibilities, but the effectiveness of such an arrangement will depend critically on the complexity of the operations and is best determined by the licensee.

4

Again the main issue we have with DG-0005 is that it is too prescriptive and often prescribes practices that are not effective.

10. Page 58344, column 2, paragraph 2:

"7. Should Broad Scope Licensees Be Allowed to Make Changes in Their Radiation Safety Program Similar to Those Authorized for Production and Utilization Facilities".

Broad Scope licensees are already allowed to make changes to their program without making a formal license amendment application. There are several practices that are cmrently allowed. Some licensees have specific wording in their license or license application that allows a certain amount of flexibility. In other cases NRC will grant verbal authoriz.ation to a change from license conditions. These changes either maintain or improve performance and are documented for NRC inspection. Where necessary, the changes are subsequently included in an application when a substantive license amendment or license renewal is needed.

The NRC also provides for changes in Emergency Plans without formal license amendment. CORAR recommends that cm.rent practice for making changes to radiation protection programs should be defined in 10 CFR 33.

CORAR urges 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 authoriz.ation 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 talce advantage of rapidly changing technical improvements that can improve licensee performance in radiation protection.

11. Page 58349, column 2, paragraph 4:

"8. Should the Different Types of Broad Scope Licenses Currently in Part 33 (Types A, B, and C) Be Deleted and Replaced With a Single Type?"

While we recognize that there are few Type B or Type C licenses of broad scope, those licensees who have them want to preserve the flexibility that a broad scope license provides without having to maintain the complex radiation protection program that a Type A license requires and avoiding the submission of 5

unnecessary Emergency Plans and Decommissioning Plans. Some Type B Licensees will have difficult in achieving the current requirements for a Type A license. The NRC should consider to discontinue issuing new Type C and Type B licenses, but grandfather those that are currently active.

If the NRC intends to continue Type C licenses, there is a need to reconsider the user training requirements which are excessive for the small quantities of byproduct material authorized under a Type C license.

12. Page 58350, column 1, paragraph 4:

"11. What Balance Should be Maintained Between a Performance-Based and a Prescriptive Approach to Regulating Broad Scope Licensees?"

CORAR maintains that regulations applicable to Broad Scope licensees should be performance based and that prescriptive requirements should be limited.

The NRC should be aware that in States that do not have licensing programs, accelerators and accelerator produced radionuclides are controlled with the same level of care as byproduct material and without any prescriptive regulations.

Broad scope licensees and organizations where equivalent quantities of accelerator produced radioactive materials and radiation are managed have long found it necessary to maintain comprehensive radiation protection programs employing considerable expertise and resources. This is proof that broad scope licensees typica1.ly have mature radiation protection capability and do not need prescriptive regulations to meet performance standards. Indeed, CORAR claims that most of the prescriptive requirements in 10 CFR 30 and 10 CFR 33 are counterproductive and only add costly administrative burdens to licensee programs without any benefit to safety or society. Performance based regulations that are beneficial include occupational and public dose limits, derived limits such as these in 10 CFR 20, Appendix B, possession limits and diminimis levels including exempt quantities, excepted quantities, and exempt concentrations.

Regulations should also provide general requirements for maintaining exposures to ALARA and requiring licensee responsibility. These standards and requirements should be uniformly compatible with the standards of other regulatory agencies and recommendations of the NCRP and ICRP.

Prescriptive regulatory requirements are needed to establish a practical working relationship with the regulatory agency including licensing, inspection and enforcement procedures. Prescriptive regulations should also include notifications of overexposures and significant losses of control of radioactive material.

6

Other prescriptive requirements should be mentioned in the regulations, but applied only on a case by case basis as license conditions. These include the need for an Emergency Plan, Decommissioning Funding Plan and other conditions typically applied to licenses.

Most of the prescriptive requirements currently contained in the regulations should be transferred to regulatory guides and presented as examples of radiation protection program elements that can be used to satisfy regulatory requirements.

The value of such an arrangement is that it forces licensees to take responsibility for their radiation protection programs and returns the regulator to a proper oversight function rather than prescribing how licensees should manage their operations.

CORAR has submitted additional comments on 11/27/96 on the need for risk:-

informed performance based regulation in comments on NRC's Strategic Assessment and Rebaselining Initiative. These comments also include CORAR's recommendation for an independent radiation standard setting agency to replace the EPA in this function.

13. Page 58350, columns 3, paragraph 5:

Management means the chief executive officer (or equivalent) or that person's delegate or delegates."

This is a useful definition of management.

14. Page 58350, column 3, paragraph 6:

"Radiation Safety Committee means a committee responsible for the development and administration of a licensee's radiation safety program, including responsibility for approval of all proposals for radionuclide use and users."

The best organization for administration and development of the radiation protection program in a major manufacturing facility is line management Management has ultimate responsibility, takes the necessary action and controls the resources needed for an effective program. Managers may also serve as members of the Radiation Safety Committee (RSC). The RSC is usually the preferred group for reviewing and approving radionuclide use and users. The proposed definition for RSC would undermine current effective programs at manufacturing facilities. This is a good example of how a prescriptive requirement from a regulatory agency can be counterproductive.

7

15. Page 58350, column 3, paragraph 7:

"Radiation Safety Officer means the individual, identified on the license, responsible for the day-to-day operation of the licensee's radiation safety program."

Consider the following definitions:

"Radiation Safety": Protection of personnel against harmful effects of ionizing radiation by talcing steps to ensure that people will not receive excessive doses of radiation and by monitoring all sources of radiation to which they may be exposed.

"Radiation Protection". Legislation and regulations to protect the public and laboratory or industrial worker against radiation. Measures to reduce exposure to radiation.

CORAR observes that most broad scope licensees control radiation to preclude safety concerns and that they are more properly involved with radiation protection. We would recommend the term Radiation Protection Officer rather than Radiation Safety Officer in the context of this proposed rule.

In major manufacturing facilities where hundreds of employees are working daily with licensed material the radiation protection program is the responsibility of many supervisors who supervise day-to-day operations and support services. It is not feasible that one person can be responsible for the day-to-day operations of hundreds of employees. In major manufacturing facilities the Radiation Protection Officer (RPO) is appointed to liaise with regulatory authorities, address regulatory, licensing, inspection and enforcement issues and provide technical and regulatory consultation to the RSC and line management. In some major manufacturing facilities, the RPO may also manage a Radiation Protection Support Group who's main function is to audit the uses of licensed material and document data to demonstrate compliance with regulatory requirements and license conditions. Use is often made of the RPO and Radiation Protection Support Group to utilize their particular expertise in providing services to the licensed material users such as dosimetry and training services. Considering that these arrangements have been found most effective through decades of operational experience, CORAR contends that the proposed rule is unworkable at complex facilities and at facilities where regulatory requirements are complex.

This is another example of where a prescriptive requirement for the duties of a Radiation Protection Officer are counterproductive and will undermine current effective programs at major manufacturing facilities.

8

16. Page 58351, column 1, paragraph 5:

"Applications for a new license, an amendment, or a renewal of a specific license of broad scope.. "

CORAR has submitted comments on NRC's Business Process Re-Engineering initiative. CORAR urges that the license amendment procedure should be made more flexible and provide licensees with the opportunity of maintaining up-to-date licenses and diBcarding obsolete material from the license. Such a program would result in broad scope licensees having concise and easy to manage and easy to use licenses instead of the patchwork sequence of license attachments that currently prevails. CORAR recommends that the license amendment process be improved and the license renewal process deleted.

In the subsequent text following the above sentence, the term "applicant" is used without definition. Is the 11 applicant11 the licensee, the licensee manager or the RPO? A definition and some discussion would help clarify this issue. The NRC should be aware that some Agreement States have difficulty with defining who can be acceptable as an applicant.

All the requirements listed under this section appear reasonable and appropriate to place in regulations to foster an effective working relationship between the NRC and licensee. Exceptions are references to Sec. 33.21 and 33.22 which are addressed below.

17. Page 58352, column 1, paragraphs 1 and 2:

"Sec. 33.21 Radiation Safety Officer.

(a) A licensee shall appoint a Radiation Safety Officer responsible for implementing the radiation safety program. The licensee, through the Radiation Safety Officer, shall ensure that radiation safety activities are being performed in accordance with approved procedures and regulatory requirements in the daily operation of the licensee's byproduct material program."

In a major manufacturing facility, it is not feasible that a Radiation Protection Officer can be held responsible for implementing the radiation protection program and monitoring daily operations. CORAR maintains that the current practice of assigning line management with these responsibilities is effective and should be confirmed. This is a good example of how a prescriptive regulatory requirement is unworkable.

9

The prescriptive requirement that a Radiation Protection Officer shall have at lest 5 years experience is impractical for some broad scope licensee and certainly unnecessary for Type B licensees. CORAR recommends that guidance on RPO qualifications should be put in a regulatory guide and presented in a flexible way such as "5 years or equivalent experience and qualifications".

This section references "Sec. 33.17 (f)", but this is not in current or proposed regulations. Clarification would be helpful.

Proposed 33.21 (c) (3) refers to "byproduct material program". It is not clear whether this is the "radiation protection program" or some other undefined entity.

CORAR recommends a definition or use of just one term as appropriate.

18. Page 58352, column 1, paragraph 12, lines 1-10:

"Sec. 33.22 Radiation Safety Committee."

"Membership shall consist of... at least one representative of management who is neither an authorized user nor a Radiation Safety Officer."

It is not clear why the NRC would want the RSC to include a manager who is not an authorized user. It would seem that to include such a person might dilute the effectiveness of the RSC if this person has no expertise in using licensed material. For some licensees, all the managers are also users.

This requirement is sometimes not workable and not effective for many licensees.

This is another example of how a prescriptive regulatory requirements can be counterproductive.

The membership of the RSC could be better presented in a regulatory guide with explanatory material. For example, this section requires members from each department, group or activity. Unless this was fully explained licensees might interpret that every group, however small, needs at least one representative which could result in a safety committee with several tens of members.

19. Page 58352, column 1, paragraph 13:

"The Committee shall meet four times a year... "

This is too prescriptive and implies that the committee is not permitted to meet five times in a year, for example.

20. Page 58352, column 2, paragraph 4:

"Ensure programs meet the requirements of 20.1101 ... "

We are unaware of 10 CFR 20.1101 in current or proposed regulations. Clarification would be helpful.

21. Page 58352, column 2, paragraphs 7 and 8:

"(ii) Review on the basis of radiation safety.... "

"(iii) Review and approve radiation safety program changes on the basis of safety;"

CORAR would recommend that 11 safety 11 , should be replaced by "protection" since this will then include ALARA considerations and is more in line with current practice which is very effective.

22. Page 58352, column 2, paragraph 11:

"(vi) Establish investigation levels for occupational doses that, when exceeded, require investigations and considerations of action by the Radiation Safety Officer;"

This requirement is too prescriptive. CORAR agrees that most licensees would want to establish administrative action levels for radiological data However, licensees should be given the flexibility to assign appropriate staff to act. The danger of this proposed rule is that appropriate action may be delayed if an overexposure is discovered when the Radiation Protection Officer is on vacation. Licensees should have access to alternate qualified individuals to act on overexposures. Any program that must depend on the constant availability of key individuals is not likely to be sustainable.

23. Page 58352, column 3, paragraph 6:

"Sec. 33.25 Supervision".

NRC should be aware that in many research communities there are no supervisors.

11

24. Page 58352, column 3, paragraphs 12 and 13:

"Sec. 33.59 Radiation Safety program changes (a) The holder of a specific license of broad scope. .. may make changes in the facility or procedures as described in the license application, after review and approval by the Radiation Safety Committee, without prior Commission approval, unless the proposed change involves a change in a specific license condition or is less than the regulations."

CORAR agrees with this provision and believes it is a necessary addition to the regulations to qualify current practice. Its main benefit is that it will encourage licensees to make changes that improve the radiation protection program.

25. Page 58352, column 3, paragraph 14 and Page 58353, column 1, paragraph 1:

(b) (1) The licensee shall maintain records of changes in the facility and of changes in procedures ... until the license has been renewed or terminated. The record must include the effective date of the change, a copy of the old and new facility or procedure, the reason for the change, a summary of radiation safety matters that were considered before making the change, and the signatures of the Radiation Safety Officer, Radiation Safety Committee chairman, and the management representative.

CORAR agrees that the licensee should maintain a record of the change.

However, we believe it should only be retained until the next NRC inspection and then incorporated in any subsequent updates to the license. This would avoid any unnecessary paperwork. The method of documentation in the proposed rule is too prescriptive and should be left to the licensee. For example, one method would be to include the change in RSC minutes. The requirement for sigl)atures is unnecessary for changes that improve the radiation protection program.

12

26. Page 58353, column 1, paragraph 2:

(b) (2) The licensee shall submit a report within 30 days of the effective date of the change, containing a brief description of any changes, including the reason for the change and a summary of the radiation safety matters that were considered for each.

This proposed rule is counterproductive. It actually involves licensees in more unnecessary work than a license amendment would. CORAR recommends that the requirement for documenting and reporting a change in proposed 10 CFR 33 .59 (b) (I) above and in (b) (2) should only apply to changes that substantially reduce the effectiveness of the radiation protection program. This is another example of how prescriptive regulations can be counterproductive.

13

DOCKETED DEPARTME RsiFfrv 10 ~ E *97 FEB 10 Al1 :39 SPRI z S ;. 2704 Jim Edgar OFFICE OF sttURts~ <l"rtciger Governor OOCKETIHG & SftJHt lit6r BRANCH February 7, 1997 DOCKET NUMBER Pft PROPOSED RULE..!..!!__;;;.--

33 Secretaty of the Commission US Nuclear Regulatory Commission ( (p I F~ 5'63</-te,)

Washington, DC 20555-0001 Attention: Docketing and Service Branch Re: 10 CFR 33 Advanced Notice of Proposed Rulemaking "Specific Domestic Licenses of Broad Scope for Byproduct Material" Gentlemen:

The Illinois Department of Nuclear Safety (Department) hereby submits its comments on the referenced advance notice of proposed rulemaking. The proposed rule represents changes to 10 CFR 33 that would codify current licensing guidance and practices associated with licenses of broad scope. Our specific comments concerning the general considerations are as follows:

Q 1. Should the Responsibilities of Licensee Management for the Radiation Safety Program be Specified in Part 33?

The drafted 10 CFR 33.12 and 33.17 rules adequately state what the responsibilities of management should be. Guidance should state that responsible individuals in the management structure must be identified by the licensee in its application. The NRC has stated that some of the failures at broad scope facilities are a result of weak management oversight. The Department believes that such weaknesses may also be a result of duties and responsibilities not being clearly assigned or understood, or there may be uncertainty as to who is responsible for a particular facet of the radiation safety program. Guidance should state that management is responsible for ensuring adequate financial and personnel resources are available in order to implement an effective radiation safety program that complies with applicable regulations and note their responsibility for performing a review of the content and implementation of the radiation safety program on an annual basis (10 CFR 20.ll0l(c)). This review may be done by the Radiation Safety Committee (RSC) provided a quorum including management's representative is included in the review process.

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US Nuclear Regulatory Commission Page2 February 7, 1997 Q2. Should the NRC Incorporate Requirements for the Duties and Responsibilities of the RSO and RSC?

Duties and responsibilities of both the RSO and the RSC should be codified as they appear in the drafted language. This would clearly identify the obligations of each of these major radiation safety functions without dictating the means by which those obligations must be met. With regard to establishing minimum training and experience criteria of the RSO, the Commission may be best served by reviewing comments received from the publishing of Task OP 722-4 "Draft Regulatory Guide and Value/Impact Statement for Qualifications for the Radiation Safety Officer in a Large-Scale Non-Fuel-Cycle Radionuclide Program." Codification of training and experience should only require a minimum of one year of experience in applied health physics managing similar radiation safety problems regardless of the extent of formal training. The five year requirement is unduly burdensome, limits regulatory flexibility and is inappropriate for some licenses of broad scope.

Q3. Should Specific Minimum Training and Experience Criteria for Authorized Users be Incorporated Into Part 33?

The issue of codifying the minimum training and experience necessary to be named an "Authorized User" should be approached carefully. Although the largest portion of such individuals under broad scope authorizations are generally physicians or researchers with a fairly extensive background, there are a number of others whose backgrounds and authorizations vary widely. Personnel such as radioactive waste collectors, process supervisors, maintenance foremen, and housekeeping supervisors may be permitted limited functions involving handling of radioactive materials or sealed sources in devices outside of research and medical uses under current authorizations. As such, they may be an "Authorized User, but not as currently specified in 10 CFR 33.15 or 10 CFR 35. The Commission should simply require the licensee to put forth a plan of what they consider an "Authorized User." This will allow necessary regulatory flexibility.

Q4. Should the NRC Incorporate Specific Requirements for Inventory and Accountability of Byproduct Material in Use, or Modify its Existing Guidance?

US Nuclear Regulatory Commission Page3 February 7, 1997 It is not necessary to codify inventory and accountability records of material in use. 10 CFR 20 currently requires these records to be maintained by the licensee. In 10 CFR 33 the Commission should only require licensees to describe the means by which they will comply with this requirement for radioactive materials in active use, as waste or in sealed sources/devices containing sealed sources. The language drafted in 10 CFR 33.12 allows this necessary flexibility. In the Department's experience, licensees typically have used an annual or semi-annual bookkeeping method involving summaries submitted by the Authorized User to the RSO for tabulation. Physical confirmation is usually on a random basis at the discretion of the Radiation Safety Officer. Inventory of sealed sources and devices containing sources is typically performed at time of leak test or semi-annually, whichever is more frequent. Such flexibility should continue to be available to licensees and regulatory agencies.

Q5. Should the NRC Consider Risks Associated With Internal Exposure Pathways (e.g., Ingestion, Inhalation, Absorption) Separate From Those Associated With External Radiation?

It is not appropriate to resolve the issue of dose estimation and risk assessment within the context of 10 CFR 33 only because recent issues involved broad scope licensees. This topic should be dealt with in any future revisions of 10 CFR 20. Risk from internal exposure involves a great number of variables which are difficult to reconcile, let alone codify ( e.g., such as in cases of deliberate misconduct), and have been discussed at length in separate fora. Consideration should be given to the necessity of any specified or increased protective measures. This may include new or revised guidance concerning security of radioactive material, the appropriate frequency of contamination monitoring in research environments and revised frequencies for routine bioassays for P-32, P-33, S-35, radioiodine or tritium. Current NRC policies rely on the experience and knowledge of the RSO to establish monitoring frequencies in research environments. If appropriate guidance is to be developed or modified, the NRC should study the intake/transport of radioactive material from the work environment (under actual work conditions) which may lead to an intake.

Q6. Are There Other Specific Aspects of the Draft Regulatory Guide DG-0005 That Should be Codified in Part 33 .

US Nuclear Regulatory Commission Page4 February 7, 1997 As drafted in the proposed rule, applicants should be allowed freedom when establishing administrative procedures, but they must have and submit written policies or procedures for specific functions such as inventory control and accountability, audits, safety evaluations of facilities, frequency of re-evaluations, training of users, exposure control, etc. The Department's previously submitted comments to the Regulatory Publications Branch on DG-0005 dated January 5, 1995, and regulations drafted by the Department, also outline this regulatory framework.

- Q7. Should Broad Scope Licensees Be Allowed to Make Changes in Their Radiation Safety Program Similar to Those Authorized for Production and Utilization Facilities in Sec 50.59?

Broad scope licensees should not be allowed to make changes in their radiation safety program which varies from that submitted for review. This area of regulation (i.e.,

ministerial changes) is too subjective to be of value in enforcement. What may be considered not potentially important to safety by a licensee, could be of concern to the Department. Instead, sufficient latitude should be incorporated in submitted policies and procedures such that the flexibility necessary to run a broad scope license already exists within the applicant's radiation safety program. The applicant should be advised of this position in guidance.

- Q8. Should the Different Types of Broad Scope Licenses Currently in Part 33 (Types A, B and C) be Deleted and Replaced With a Single Type?

All types of broad scope licenses should be replaced with a single license type which is most similar to the current Type A License of Broad Scope. The autonomy granted under Type B licenses 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 stream11ning of licensing and inspection of these licenses.

US Nuclear Regulatoty Commission Page 5 February 7, 1997 Q9. Should a Categoiy for "Master Materials Licenses" be Incorporated Into Part 33 With the Respective Necessary Requirements? and QlO. Should Requirements for "Multi-Site Facilities" be Codified in Part 33 or Should This be Defined Only in 10 CFR 30?

The Department has 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 under exclusive federal jurisdiction. Similarly, we have no comment regarding Multi-Site Facilities under NRC jurisdiction. The Commission may note that in Illinois these facilities are licensed on a case-by-case basis under broad scope authorizations as well as specific licenses to meet the needs of the licensee as well as that of the Department. In these cases however, an RSO is established for each site and named on the license.

Qll. What Balance Should be Maintained Between a Performance-Based and a Prescriptive Approach to Regulating Broad Scope Licensees?

It appears a good balance has been adopted in the drafted regulatory language. In order to limit the expenditure of limited resources associated with an inspection intensive program, regulations have been developed which require the submission of a framework 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 scope 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 active monitoring for radiation levels and contamination should be encouraged and verified through routine, frequent compliance inspections. As stated in the drafted regulatoiy 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.

US Nuclear Regulatory Commission Page6 February 7, 1997 Comments Concerning Drafted Regulatory Language and Other Topics We have noted several good ideas which have been developed in the drafted possible regulatory language. One example is the allowance for scheduling in the requirement that the RSC meet four times a year at a frequency not to exceed 4 months.

Another is the drafted Section 33.25 for use of radioactive material under the supervision of an authorized user. However, the requirement that RSC membership consists of"one user from each department or group" could lead to a committee of 24 or more at academic facilities such that the committee would cease to be an efficient functioning body. Instead, guidance should suggest a cross section of all users in order to ensure adequate representation and require only a minimal membership on the committee to allow this flexibility. Also 10 CFR 33.21(c)(3) should be revised as a requirement of the RSC rather than restricted to the Radiation Safety Officer as they are charged with overseeing the radiation safety program. The content of the RSC meeting minutes should be stipulated in the regulation as well as they are the primary means by which the actions of the RSC are documented.

An additional suggestion is to arrive at a technically based monitoring program for areas where radioactive materials are used for facilities where research and development occurs (e.g., academia). As noted earlier, previous technical assistance instructed us that determination of monitoring program adequacy was best left to the discretion of the facility RSO. Subsequent information notices, NUREG reports and news accounts concerning broad scope facilities cause us to question this opinion. Developing a monitoring program is extremely subjective and its effective implementation varies widely based on the facility and the RSO. A determination of adequacy of the monitoring program is typically based on performance and effectively left to the discretion of the inspector without the benefit of any regulatory guidance. Guidance for these monitoring programs have been established for medical facilities and manufacturing facilities but not for research environments which have recently been subject to scrutiny. Establishing a technically based survey program should entail an evaluation of the risk associated with access to small quantities of radionuclides.

US Nuclear Regulatory Commission Page 7 February 7, 1997 The Department is interested in receiving copies of comments or summaries of comments which the Commission receives as a result of publication of the advanced notice of rulemaking as we are in the process of similar rulemaking. It is through these cooperative efforts that both the Agreement States and the NRC can benefit the most and take advantage of the limited resources available. If you have any questions regarding these comments, do not hesitate to call me, Kathy Allen or Daren Perrero at (217) 785-9947.

Sincerely,

~(!_j!~~

Steven C. Collins, Chief Division of Radioactive Materials SCC:dmp cc: Jim Lynch, State Agreements Officer

DOCKET NUMBER" (j)

PROPOSED RULE 33~

February 7, 1997

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American John Hoyle, Secretary *97 FEO -7 A11 :32 Nuclear Regulatory commission College of Washington, DC 20555-0001 Nuclear OFFICE OF S ECR TA Y

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Re: Fed. Reg. 61(221), 14 Nov. 96, pp. 58346-58353: California Specific Domestic Licenses of Broad Scope for Chapter Byproduct Material, ANPR. Dorothy Duffy Price Executive Director

Dear Sir:

Box 31 Los Altos, CA 94023 The California Chapter of the American College of Nuclear TEL (415) 949-1341 Physicians wishes to comment on the proposed changes to FAX (415) 949-1341 10 CFR Part 33 regarding licenses of broad scope, as published in the Federal Register on November 14, 1996.

The Nuclear Regulatory Commission (NRC) states that it wishes "to clarify the regulatory and health and safety basis of current licensing practices and to provide licensees with the flexibility to make certain types of changes to their radiation safety programs.". It further states that the proposed changes are "supported by two recent events of a similar nature, involving phosphorus-32 (P-32) internal contamination of individuals at large biomedical research facilities.". These two well publicized incidents at NIH and MIT were terrorist type acts that can not be prevented by a change or clarification of regulations. Indeed, the NRC never states how their proposed rule changes would prevent such terrorist type incidents, and considerable discussion supporting this point took place at the May '96 CRCPD meeting in Albuquerque which was well attended by NRC staff and management.

The NRC's statement that the proposed new rules would result in "the development of a standard license condition for broad scope licensees that is functionally equivalent to 10 CFR 50.59 for nuclear power reactor licensees" is a demonstration of a flawed perspective. The proposed changes would not merely be an example of diminishing returns, but we believe it would actually be counter-productive.

There are always additional problems in administering a radiation safety program at renowned universities and research laboratories. This is especially true when there is a proliferation of new regulations. It is extremely difficult to convince a Noble Prize winner or other famous clinical and basic researchers to change the way they do science or stop and write new policies and procedures merely to adhere to a new regulation by the NRC, when these researchers can give you very cogent arguments showing that the operation of their laboratories do not represent a hazard to laboratory personnel or to the public. Most COHN197.N'RC FEB 1 3 1997

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February 7, 1997 John Hoyle, Secretary Page of these researchers are aware of the NAS/IOM Report condemning the overregulation of byproduct material by the NRC. New regulations that will not prevent terrorist acts, such as the P-32 incidents, will not improve radiation safety. such regulations will be resented and make the RSO's job more difficult.

This is best demonstrated in the NRC's own words: "Generally, 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." NRC goes on to state that there were only 38 events in a 4 year period that resulted in some type of enforcement action. Even though these events did not apparently imperil the public health, the NRC is concerned 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 broad scope license to a license for a nuclear power plant. If the NRC is so concerned 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.

The NRC clarification of 10 CFR Part 33 is also not needed.

Speaking of the current regulations, the NRC says, "In practice, Part 33 reduces the administrative burden for both licensees and the Commission without reducing safety standards.". It goes on to acknowledge that a broad license is only issued to "large-scale activities with licensed material under oversight by persons with extensive training and experience in radiation safety.". It also states that these broad licensed programs "do not require the same degree of regulatory oversight" as other types of licensees, i.e., broad licensed programs have the greatest expertise and require the least amount of clarification. Therefore, there is certainly no compelling reason to promulgate new regulations that will require everyone to revise or develop new written policies and procedures, which will not be paid for under existing clinical, research, or other funding mechanisms.

The NRC points out that it has utilized a regulatory guide to clarify certain regulations. This approach should be used to change the definition of "ministerial change" or to otherwise increase the flexibility of broad licensed programs. The Regulatory Guide could also be used to consolidate the three types of broad licenses. A regulatory guide, however, should not be used to impose new requirements or regulations that increase the burden on licensees. otherwise, it is de facto regulation without honoring the requirements of the Administrative Procedures Act. A regulatory guide should give guidance that COKNtr7.NIC

February 7, 1997 John Hoye, Secretary Page permits the desired flexibility. We see no need for a further definition of the requirements and duties of the RSO and RSC. The NRC already requires local management to make a written statement of delegation of power to the RSO for the operation of the radiation safety program.

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 this masters materials program until there is more experience in evaluating and regulating such new programs.

In summary, the California 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-IOM, whose opinion was sought by NRC. The costs for this study, $1.25 million, were borne by NRC medical licensees who wish to see the NAS-IOM advice implemented.

~/3.a.J Marvin B. Cohen, M.D.

President, ACNP-California Chapter Professor of Medicine and Radiological sciences, UCLA

• Chief, Nuclear Medicine Service VA Medical Center, Sepulveda, CA

• Dr. Cohen's opinions are his and those of the ACNP and are not necessarily those of the Department of Veterans Affairs.

cc: Chairman Shirley Ann Jackson Commissioner Greta J. Dicus Commissioner Nils J. Diaz commissioner Kenneth c. Rodgers Commissioner Edward McGaffigan Hugh Thompson, Jr., Deputy EDO Edward Jordan, Deputy EDO MBC:sfd CORH1'7.NaC

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UNITED STATES DEPARTMENT OF COMMERCE National Institute o ~ rds and Technology Gaithersburg , Marylan SNRC DOCKET NUMBER "97 FEB -4 P3 :56 January 23, 1997 PRCPOSED RU _____ 33 Secretary

( IP/ F/(5~3'-f~)

Nuclear Regulatory Commission Washington, D.C. 20555-0001 Attn : Docketing and Service Branch Ref: RIN 3150-AF54 (61FR58346)

Dear Sir:

The attached detailed comments are offered in response to the notice of proposed rulemaking for 10CFR33 (61 FR58346). After careful and detailed review of this notice by NIST management, by members of the Ionizing Radiation Safety Committee, and by the Health Physics staff we must conclude that NIST, the radioactive material users' community, and the Nuclear Regulatory Commission are best served by the regulations in their current form . The potential rules, as represented by the various 'questions', and the specific suggested rules clearly present a regulatory scheme that would be less effective in terms of public safety and regulatory effectiveness, more costly in terms of licensee resources, and in certain aspects virtually unmanageable in terms of clear definition of responsibility.

The general result of these 'prescriptive' proposals will be to dilute and diminish the professional management of licensed activities, creating an atmosphere of rote regulatory compliance rather than the professional application of basic principles for public and worker safety. In particular, the proposed makeup and responsibilities of the Radiation Safety Committee create an unmanageable structure with confused lines of authority and responsibility that are incompatible with the NIST organizational structures and with general principles of accountability.

the onerous provisions of the proposed 33.25(b) creates a potential liability for managers that at a minimum will detour any reasonably intelligent person from voluntarily participating in licensee management, e.g., RSC participation, because they will be held liable for actions beyond their control.

In summary we urge you to continue the current licensing practices which allow for the diverse nature of licensees.

Sincerely, fEB o6 1997~

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• Chief, Occupational Health and Safety Division Chris Kuyatt Chairman Ionizing Radiation Safety Committee Attachment U.S. DEPARTMENT OF COMMERCE NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY GAITHERSBURG, MD. 20899-0001 NISI OFFICIAL BUSINESS PENALTY FOR PRIVATE USE, $300

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NIST comments on the notice of proposed rulemaking for 10CFR33 (61 FR58346).

Background

NIST summary comment: Insufficient information is provided in this notice to demonstrate a need for revising 10CFR33, or in most cases, a need for specific changes suggested in this proposal.

The NRC notes a review of Part 35, and a NUREG published for comment, but does not describe the similar failings or problems between the two programs such that the experience from Part 35 is relevant to Part 33. What elements are similar, what was the success of NRC's response to these problems, and how would this be applied to Part 33 licensees? Given the rather significant difference between the two programs in terms of the use of radionuclides the Part 33 community probably is unaware of the history under the Part 35 program. Further, the discussion as contained in this notice does not relate to, justify, or support the proposed changes to Part 33. While some of the proposed changes are attractive it is our conclusion that Part 33 is effective as currently published and the

- discussion in this notice does not appear to offer any arguments to the contrary.

1 It is asserted that the need for a change to Part 33 is reflected by the two 32 P events. These two events were so out-of-the-ordinary it is difficult to see how it can be asserted that they are reflective of any aspect of any licensee program. Given the continuing investigation in at least of one of these events it is difficult to make definitive statements about them, but given the nature of these events it would appear that they were deliberate events initiated by one or more individuals in a manner that is totally outside the scope of controls in 10CFR33; unless NRC is intending to change the underlying risk basis for these regulations, such as making the licensee responsible for blatantly criminal acts of its employees. [This latter point is not indicated in this proposed rulemaking.] Further, other than broad generalizations about licensee controls, there have been no licensee controls identified that could have prevented these events. Hence the justification for citing these events in support of the proposed rulemaking is unsupported in this proposal. None of the proposed rule changes are identified as a solution to the problem presented by these events.

If the two 32 P events are the most significant that can be identified in support of this proposal there must be a related spectrum of lesser failures identified via the inspection program that could be summarized to support this proposal. Is such data available or is the presumption for a need to revise Part 33 basically anecdotal? As a licensee and as an observer of the regulatory system it is our perception that the current NRC regulatory model has been very successful in effectively and efficiently protecting the public and radiation workers. The combination of the licensing process and an independent inspection process together with flexible, non-prescriptive (i.e., performance oriented) regulations can only be described as a success despite a number of problems over the years. We hope that this 'proposed rulemaking' is simply the public process by which the identified questions can be openly discussed and does not reflect an assessment of failure of 10CFR33.

Requests for Comments on General Considerations Question 1: Should the responsibilities of licensee management for the radiation safety program be specified in Part 33?

NIST Recommendation: No.

As indicated, DG-0005 addresses this issue. Is there any broad scope licensee that the NRC licensing group has licensed that does not meet these provisions? Our experience is that the NRC Part 33 licensing group pretty much gets what it wants and the licensee knows what is wanted via the

Regulatory Guide. If this is the case, how is the regulation defective?

Given the wide variety of licensees, and even broad scope licensees, the current process would appear to be the most flexible from a regulatory point of view. Any prescriptive regulation would have to be a compromise that at best fitted all licensees less effectively and hence served NRC less effectively than the current approach. Thus we would argue against making Part 33 more prescriptive and against adding unnecessary detail.

Question 2: Should the NRC incorporate requirements for the duties and responsibilities of the RSO and RSC?

NIST recommendation: No.

[Observation: This question certalnly offers the opportunity to guarantee employment for health physicists, and hence opens the posslblllty for biased responses.]

The discussion offered by NRC for this proposal does not identify any deficiencies in the current rules. The mere lack of a regulation is viewed by most as a plus. Does NRC have data indicating a difficulty in this area? Our experience in our interactions with the RSO's of other organizations is that they are at least adequately qualified (and usually outstandingly qualified) for the position. The nature of the audience who will respond to this question (i.e., readers of the federal register) is that the NRC will get a very biased response because of this knowledgeable audience. It would seem that this question would be better addressed by a direct sampling process for the result to have any meanin,g.

A member of the NIST staff, while serving on a committee, has in the past reviewed the CV's of several hundred Certified Health Physicists and can attest that a set of criteria based on some profile of education and experience would certainly exclude some of these highly qualified individuals, ignoring their certification status. Simply stated, while it is easy to write criteria that guarantees a qualified RSO, e.g., a Ph.D. in Health Physics with an ABHP certification, one that simply represents the necessary qualifications that also assures the NRC objective as a function of the full range of types of licensees will assuredly exclude qualified candidates. This would presumably be undesirable.

Question 3: Should specific minimum training and experience criteria for authorized users be Incorporated Into Part 33?

NIST recommendation: No, NRC should not incorporate specific requirements into Part 33. This should be left to the licensee's Radiation Safety Committee.

What does NRC mean by an authorized user? Is this the person who designs the experiment/usage, formulates the usage procedures including the safety precautions, and obtains all required approvals (sort of like a licensee applicant to NRC); is this a worker who simply uses the material in a knowledgeable way as part of an experiment or established usage protocol while following those established procedures; is this the technician performing manipulations under general supervision; or is it some combination of these? Clearly these are different users with drastically different qualification requirements, depending on the level of activity and proposed usage envisioned. While there are not any specific education and training requirements in 10CFR33 this proposal has not indicated In what manner the basic requirements of 10CFR 19 are deficient.

As a licensee we have not had any difficulty under the current regulations of ensuring that proposed users have adequate experience and training. As with all professions users build on experience so that a user needs some related experience to get approval for a higher level of activity or an increased level of usage complexity, and new users are required to have direct supervision. We have

not generated explicit education or training requirements beyond those of 10CFR19, but our subjective application of the 10CFR 19 requirements have in general been successful. As an example, the first time worker using relatively low activities of a low toxicity nuclide doing rather simple manipulations would require little beyond very basic knowledge (as prescribed in 10CFR19).

If specific education and training requirements were to be incorporated into 10CFR33 they should identify several kinds of users and should reflect the following aspects of radionuclide usage:

form - sealed versus unsealed usage is an obvious element for the matrix of experience and education requirements.

level of activity - clearly, unsealed use of Appendix C quantities handled in a simple manner requires minimal prior experience, while at the other extreme quantities in excess of 106 ALI (or those producing dose rates in excess of 100 mrem/h) require substantial experience.

nature of the unsealed manipulation - simple wet dilutions of even significant activities can be done by minimally trained workers while more complex handling, e.g., powders, elaborate chemistry, requires detailed training and experience.

authorized-,1scope of usage - a senior user is allowed more flexibility to adjust parameters and experiment techniques while an entry level user has more prescriptive limits in the usage authorization.

Question 4: Should the NRC Incorporate specific requirements for Inventory and accountablllty of byproduct material In use, or modify Its existing guidance?

NIST recommendation: No, these procedures should be left for the licensing and inspection process. However NRC should establish a quantitative level below which the licensee is not required to perform centralized accounting, i.e., the licensee is only required to maintain accountability at the user level.

This topic raises 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 all licensed 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.

Specific issues of concern are:

- how is a source accounted for, particularly those with short half-lives and those that are difficult to assess or to detect independently?

- how does the licensee distinguish between user accountability and control for authorized sources and central accounting and systemic control for all licensee sources?

- should sources of less than a certain half-life, e.g., 18 days (10% of 180 day accounting period),

be exempt from central accounting? A suggested wording is if the activity of the source 15 days after acquisition is less than some value, e.g., a fixed activity like 10 µCi or less than the Appendix C value, central licensee accounting is not required. This has the attributes that: (1) recognize that the user is not likely to lose track of a source immediately after acquiring it, and (2) provides flexibility for short half-life materials, particularly those made at research reactors or milked from longer-lived precursors.

- should sources of less than a certain activity, e.g., Appendix C quantities or quantities less than 1% of the license limit, be exempt from central accounting and only be subject to periodic user audits of accounting?

- if NRC requires accounting for unsealed sources, what are the precision criteria to be?

Allocation (i.e., extracting portions of the source) and accounting precision is highly variable among

different kinds of users, particularly those doing 'relative' experiments. Even the step of establishing an arbitrary precision value will necessitate additional work for some users simply to demonstrate compliance to those (possibly arbitrary) criteria.

5. Should the NRC consider the risks associated with Internal exposure pathways separate from those for external radiation?

NIST recommendation: Most emphatically, no.

The 10CFR20 revision which rectified this historical error should not be undone. In virtually all cases generic internal dose modeling is an overestimate of the individual's exposure. And in the cases specifically cited the dose estimates were certainly as good as external dose estimates in analogous events. If anything, under the current rules internal dose risks for the typical worker are more realistically estimated than external exposures (by the very definition of these doses in Part 20) so that added special considerations for internal exposure are not needed.

On the other hand if NRC has some mechanism, or can sponsor research that will identify a mechanism that would assist the licensee in distinguishing inhalation versus ingestion uptakes based on routine bioassay data it would help identify events similar to those previously discussed.

6. Are there other specific aspects of DG-0005 that should be codified?

NIST recommendation: No.

7. Should broad scope licensees be allowed to make changes In their radiation safety program similar to 50.59?

NIST recommendation: Yes, depending upon the nature of the rule implementation.

Under our current license as structured by NRC we have

- a section in the application that represents boilerplate conditions,

- a section that represents implementation of those conditions and which may be changed by NIST, subject to annual notification to NRC,

- a license conditions document issued by NRG,

- and implementing procedures that can be changed subject to approval by the RSC.

If this proposal would remove one of those layers there would be a benefit, albeit a minor one since we are talking basically about the elimination of 6 or 8 pages of material. Presumably this proposal would necessitate a more complex 'license conditions' document from the NRG, comparable to the Part 50 'Technical Specifications'. We suspect that for most facilities this would be a wash, i.e., of no significant advantage.

A possible significant disadvantage would be that while it would reduce the licensing workload at NRC, it would increase the inspection workload of a basically paperwork activity thereby decreasing inspection time of 'rea,I' licensee activities.

8. Should the different types of broad scope licenses currently In Part 33 (Types A, 8, C) be deleted and replaced with a single type?

No additional comment.

9. Should a category of "master materials licenses" be created?

NIST recommendation: No, if this category would apply to NIST as we are currently licensed.

This would seem a matter of simple practicality. How many licenses does NRC have that fit this category? Is the tradeoff of creating a different regulatory framework justified by otl:ler resource savings? This proposal does not offer any information of this sort.

For NIST, and probably for most licensees 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 state licensing by virtue of being a federal entity.

10. "Multl-site" licenses.

No comment.

11. What balance should be maintained between a performance-based and a prescriptive approach to regulating broad scope licensees?

The balance should lean as far towards performance-based as possible. Given the wide variety of licensees in the U.S., any prescription rule is an ill-fitting shoe for some, if not many, licensees. Only the fourth element, i.e., an intolerable outcome, should be the determining factor in necessitating a prescriptive rule. The NRC regulatory process has demonstrated remarkable effectiveness and success, even in view of noted failures. While it is always worthwhile to review and refine a successful product it should be recognized that 10CFR is just that, and sweeping changes in regulatory philosophy are not needed.

Specific Examples of Possible Regulatory Language:

NIST recommendation: These draft suggestions have significant problems, as indicated in the comments below. In most cases we recommend against adopting these suggestions.

Item 2- A.U.: The definition of 'authorized user' is simplistic in that it does not reflect the spectrum of different types of users and the different qualification requirements. In particular it does not distinguish between users with different levels of authorized use, either in usage complexity or activity level. It has the detrimental implication that all authorized users are the same by virtue of being so labeled by this NRC rule. This term Is best left undefined.

Item 2- RSC: The definition of RSC is deficient in that a committee neither develops nor administers.

This definition conflicts with management responsibilities. A committee reviews and approves.

Further, 'responsibility for approval' is unclear in a similar manner. That is, does NRC intend that the committee personally and a priori review and approve each and every proposal and radionuclide order or does NRC intend that the committee oversee a program conducted by the RSO and reviewed by the committee on a regular and timely basis for accomplishing this? In the former case for large programs the committee will have a fulltime workload, and hence cannot be constituted of representative members as NRC specifies in the proposed rules since those people have other jobs.

Item 2 - RSO: The definition should read" ... the individual, identified on the license, responsible for the development and administration of the licensee's radiation safety program." At smaller facilities the person qualified to be the RSO in terms of education and experience may have other primary job

functions and in that instance may not directly oversee "day-to-day operations." The essential element is the person who administers the program, i.e., has authority to hire, fire, approve fund expenditures, etc.

Item 3: The requirement to "maintain adequate safeguards against ... loss of records" is unreasonable. While a failure-free program is always a desirable objective some sort of reason must apply in judging failures. A single failure should not represent a programmatic failure, which position this rule would mandate. We suggest changing 'adequate' to 'reasonable' if this proposal is to be retained.

More generally, this proposal represents an unneeded, added regulatory layer. NRG already has requirements for records in certain specific areas, specifies retention requirements, and can issue citations for the lack of those records. What is the legal necessity for another nail?

Item 4(a): see the earlier comment. In summary, deletion of the specific B and C categories would result in a loss of clarity for a reader of the regulation. The current rule provides a sense of scale that the proposal loses. The proposal gives the impression that NRG is treating multicurie licensees and mlcrocurie licensees the same.

Item 4(b): As defined this has no impact on most Type A broad scope licensees, unless the underlying NRG Intent is to force most current Type A licensees into this category. In that case it represents an unneeded and unnecessary added administrative workload for those licensees in that it 1 would mandate another layer of bureaucracy. Please clarify NRC's intent. No data is presented to demonstrate that this licensing category would serve any useful purpose other than to codify an existing NRG practice, which If currently legal needs no further codification.

Item 5(a):

- Section 30.32(g) forces many usages to be treated as unsealed sources, results in a significant loss of credibility *among the users in terms of perceived risk, and results in an unneeded expenditure of scarce radiation safety resources. For example, a liquid in a sealed glass vial certainly does not meet the Part 32 criteria for a sealed source but clearly is not an unsealed source and containment failure is easily recognized by a knowledgeable user. Surveillance procedures for unsealed sources are clearly inappropriate for such a source usage. Sealed sources under Part 33 licenses should be defined as sources that are adequately contained for their intended use. This is not the same (and should not be the same) as Part 32 sealed sources and need not have the same performance requirements. Such sources under a Part 33 license, as opposed to a Part 32 license, are subject to a higher quality continuing surveillance and in general are used by more knowledgeable users. NRG should take this opportunity to recognize this and explicitly exclude 30.32(g) from applying to Part 33 licensees.

- Presumably the circular reference created by 30.33(4) does not cause Parts 32,34-39 to apply to Part 33 licensees. If this is not the case, then additional time is requested to evaluate the impact of those sections on Part 33 licensees.

Item 5(b): This in essence prohibits a new organization from acquiring a Type A license, regardless of the education and experience of its staff. Given that it is people who are essential to an acceptable program this requirement should Include a provision based on the RSO and RSC experience base.

While such applications are probably a rare event there is no reason stated in this proposal to arbitrarily exclude them.

Item 5(c): Presumably 'previous experience' includes the previous experience of the licensee's personnel, both in terms of a new license (see comment above) and in terms of a license renewal.

Item 5(h)(10): This is a much more comprehensive requirement than that required by 10GFR19 where only appropriate training is required. If something different from Part 19 is intended then more detailed discussion of this requirement is needed. If only the Part 19 requirement is intended then that should be explicitly stated to avoid conflicting interpretations of the rule. In particular this requirement seems to be targeting non-users who are simply in some general (undefined) area near authorized work. The Part 19 requirement achieves this more directly and simply unless the intent is to require training for persons in unrestricted areas, in which case this proposal is fundamentally defective. On the other hand if the intent is to prescribe what areas are to be included in the licensee's Restricted Area this proposal lacks clarity to that effect.

Item 5(h)(13): This looks like an authorization for a Part 33 licensee to perform a limited decommissioning of a previously licensed activity site, e.g., a lab. If this is what is intended this is a significant, positive change to the rule. Our previous experience is that it took 3 years to release a single, one-room lab via the current NRG processes, during which time it stood idle. NIST recommendation: Highly desirable.

Item 6: As long as extensive revisions are being considered we suggest that some of the restrictions posed in 33.17 are unreasonable and serve no public interest. For example, 33.17(a)(2) prohibits activities covered by Part 34. But in fact any Part 33 licensee having a reasonable activity gamma source can easily and safely conduct a radiography experiment at the licensee facility. Presumably what NRG is concerned about is extensive commercial operations conducted at non-licensee owned facilities. Rather than putting such a comprehensive trap in the rules for the licensee why not be more specific in the exclusion? For parts 36 and 39 it is more difficult to hypothesize a reasonable Part 33 activity, but that does not mean that they do not exist. \Mly needlessly complicate the life of a Part 33 licensee, particularly those with limited geographical sites?

Item 6: Regarding a(3), activities for which a license is needed under Part 35 are prohibited. So why is this clause needed? Facilities doing animal research, or even those doing in vftro work, label chemicals and process them in a manner that is effectively equivalent to making them suitable for human use. We collect and distill tritiated water as part of our environmental sampling program, which end result is clearly suitable for human use. Is this prohibited? Many other innocuous examples could be cited. If the act of administering is prohibited unless one has a Part 35 license, then why is this rule needed? Again, it is useless baggage that just complicates the rules. [Note: At another organization one of our staff encountered this clause well into a research project, and got a waiver from NRG via a simple letter wit,h no restrictions other than to prohibit human use.]

Item 6: Regarding (b)(2), (a)(2) clearly prohibits Part 35 (human use) activities but (b)(2) proceeds to address restrictions on medical use by the Part 33 licensee. Something in clarity is being left to the imagination of the reader. If this is intended to cover the situation when NRG issues a waiver, then presumably this condition can be applied as part of the waiver process. Again, deleting (b)(2) would further simplify the rule.

Realizing that there are Part 33 licensees doing Part 35 activities we suggest that to clarify Part 33 NRG:

(1) maintain the current prohibitions in Part 33, delete all references to human use, and address these needs via the regulatory exemption process, or (2) do (1) together with a change to Part 35 to incorporate Part 33 requirements for those Part 35 licenses needed Part 33 latitude, or

(3) write Part 33 to explicitly allow Part 35 activities when certain NRC specified conditions are met.

The current phrasing is "neither fish nor fowl" but looks like a fosh or a fiwl.

Item 6: Suggest changing " ... or the name ... changes" in (c) to " .. or the person changes."

Presumably name changes due to marriage or other personal events are not a crucial regulatory issue, plus the rules should be gender neutral. In fact a slight rewording of (d)(1) would allow most of (c) to be deleted, further simplifying the rule. For example, add to (d)(1) " ... before naming, reassigning, or replacing ... ".

Item 6: Presumably the licensee has the authority to appoint an interim RSO due to the loss of the current RSO for reasons outside the control of the licensee, pending approval from the NRC of the newRSO.

Item 6: It would be interesting to hear the legal argument why (d)(2) and (d)(3) are needed when these acts, by a simple reading of 10CFR, would appear to be a violation in and of themselves.

When NRC issues a license limiting what a person can own, possess, transfer, etc., etc., is the inference in this proposal that there is some way to read that limit in a manner that one can exceed it? If so, then the inference to be drawn from this section is that NRC is only really limiting licensees 1

as prescribed by (d)(2) and (d)(3). If not, why is this needed?

Item 7: Regarding (b),

- there are a significant number of persons currently certified by the American Board of Health Physics who do not meet this degree requirement (either having no degree or the degree is in a non-science area), but who most of us would consider to be highly qualified to be RSO's. This rule needlessly excludes such qualified persons from this position.

- other degree areas are a fruitful source of health physicists, e.g., math, law, and should be recognized.

- note that the OPM requirements for designation as a Health Physicist contain exceptions to these requirements. Does this proposed rule mean that a person classified as a Health Physicist by the U.S. Government, even at a high grade level, might not qualify as an RSO? If this rule stands, will NRC initiate the needed changes to the OPM standards?

- there are clearly more limited license types, even broad license types, that do not need even the five year experience requirement, assuming these licensees are not covered by another Part.

We suggest that these qualification requirements be applied to broad licenses " ... of significant scope or complexity ... " and that for simpler applications persons with " ... more limited experience and education will be approved by NRC upon application and review of their qualifications."

Item 7: We suggest that 33.21 (c)(2) is an unnecessary detailing of the RSO responsibilities, particularly in terms of how the RSC will accomplish their regulatory responsibilities. Simply requiring the licensee to accomplish specified tasks should be all that NRC prescribes. More detail reduces the ability of the licensee to accomplish the required tasks efficiently and effectively. Similarly regarding (c)(3), 10CFR20 already requires an annual review, to which this condition presumably refers. Who performs the review should be left to the licensee management to determine. For a large licensee this might best be done by a separate review group. This narrow prescriptive approach limits licensee flexibility. If this phrase is retained (highly undesirable in our view) NRC should clarify what is intended by the difference in wording between this and the Part 20 requirement.

J Item 7: Regarding 33.22,

- the required makeup of the RSC is such that committees of enom,ous size are not only likely, but guaranteed. Such unwieldy groups in no way add to safety effectiveness and more likely will detract from it. They simply become bureaucratic logjams. While we see no solution to the generic identification of organization elements as cited in the rule, a simple solution would be to include the phrase "a committee of 5 persons (or more at the licensee's discretion) representing the major users of ... ". Even this number is large for small, limited activity licensees where such a committee would probably represent all the users talking to themselves. More desirable is the phrase " ... an appropriately constituted group, representative of licensee usages, of a minimum size for effective oversight ... ".

- for a small organization having the RSO as a mandatory member of the committee is a necessary requirement just to ensure adequate expertise on the RSC. But for very large licensees the RSO and the RSC should be independent, with the RSO as an ad hoc, non-voting member of the RSC. A large organization in this context is one with at least 20-40 independent users across at least 8-10 organizational elements. While there might not be very many licensees so classed, they should have the flexibility of organizing their RSC as an independent policy and oversight group. The rule should pemiit this flexibility.

- again, the reference to 'medical, broad scope licensees' is confusing given the presumption that such activities are licensed under Part 35. If Part 33 and 35 are used conjunctively for medical licensing this should be clarified.

- the (a)(2) requirement for quarterly meetings is excessive for many licensees. This should be left for detem,ination as part of the licensing process. For smaller licensees where the involved individuals see each other regularly anyway an annual meeting is probably all that is necessary.

Requiring committees to meet just to satisfy a regulatory requirement when there is nothing substantive to discuss is needless regulation.

- regarding the excessive detail in(a)(3), i.e., "each member shall be provided ... a copy of ... ", one wonders at the NRG experience that led to this sort of micromanagement. This sort of detail should be left to a regulatory guide, or covered by some generic statement like " ... committee activities will be conducted in a nomial, businesslike manner, leaving the licensee to detail the administrative aspects of the committee activities.

- the functions prescribed in (b)(1) are in essence management responsibilities. If the committee has these responsibilities what is management's role in the conduct of the radiation protection program? Note further that when a committee is responsible for something no one is responsible.

These responsibilities to ensure the requirements of 20.1101 are met should be changed to audit and review functions.

- the requirements of (b)(1)(ii) are particularly onerous for large programs unless this rule is interpreted as to allow the committee to delegate these responsibilities in combination with some sort of audit process. If not, then only people with nothing else to do will be appointed to the RSC. That is, the RSC will not be able to retain the more highly qualified staff in the organization.

- to expand on the foregoing comment, the greater the number of specific functions detailed for direct committee involvement increases the likelihood that the more qualified staff members will not have time to participate in committee activities. This rule should pem,it delegation of accomplishment of various tasks subject to review by the RSC.

Item 7: Regarding 33.23,

- this rule is strongly endorsed.

- we presume that (b) simply requires an internal organizational statement, not an expression of this in the license application. This pem,its administrative flexibility in keeping such a document up-to-date.

- item (a)(4) borders on conflicting with management prerogatives since it gives the committee authority to " ... initiate ... or provide corrective actions." The RSC authority should be limited to

approving measures proposed by management and otherwise prohibiting licensed activities until satisfactory measures are in place.

Item 8: It is not clear how 33.25(a)(1) adds anything to the requirements of 10GFR19, other than being more specific in several details. If this detail is needed why not put it in Part 19 since it applies equally well to other parts of 10GFR? On the other hand this is just one example of a litany of details required by Part 19 that could be listed. Why this one? If NRG judges that Part 19 should be more explicit we suggest that it be revised. Another issue is that burying training requirements in parts other than Part 19 without at least a cross-reference simply creates confusing regulations.

Item 8: Regarding 33.25(b), as worded this is unreasonably onerous. Incorporating into the federal regulations a statement of responsibility for actions beyond the reasonable knowledge and control of the licensee seems like It should be in violation of some law, if not the constitution. Some appropriate legal qualification limiting the scope of this open-ended rule is desperately needed for this rule.

Item 9: Regarding the proposed 33.59,

- if NRG is going to incorporate provisions analogous to 50.59 which provide the licensee flexibility for keeping license documents up-to-date, then it would seem reasonable to extend the licensed period of licenses issued under Part 33 in a similar manner, e.g., 20 years. This would have the obvious benefit of reducing paperwork and NRG overhead for these types of licenses. On the other hand, if the period is not extended then what is the benefit to the regulatory process to add the extensive paperwork and formalism posed by (b)(1) in this proposed rule?

- (b)(2), while obviously analogous to 50.59, incorporates a more stringent, i.e., 30 day, reporting requirement. Our current license only requires an annual report for similar actions and 50.59 similarly requires an annual report. We urge that this be changed to an annual reporting requirement.

, - in (a) it is unclear how the licensee can change the facility in a manner that it is "less restrictive than the regulations". The regulations control sources, processes, and uses. The structure of this sentence needs clarification. If this is a null requirement it should be deleted. If NRG has specific examples in mind, please cite these to clarify the meaning of this requirement.

- (c) would seem to be sett-evident. Is it necessary to clutter the rules with such statements?

Further, it is redundant with the exclusion in (a), i.e., "unless the proposed change involves a specific license condition". Such redundancies simply create potential for conflicting interpretations as well as needlessly adding bulk to the rules.

Summary In summary, we are sympathetic with a number of the proposed rule changes. However the documentation accompanying these proposed changes in general are not supportive of these proposals, either specifically or even in broad generalities. It would appear that NRG has some underlying motivation and justification for these proposals other than the few extraneous events mentioned in the Supplementary Information section. The licensee community would benefit by seeing these, and could more effectively comment on these proposals with this information in hand.

We presume given the preliminary nature of this proposal, the proposed rule's obvious need for extensive revision, and its significant impact on a large number of NRG licensees, that the revised version will be submitted to the public for further comment. Preferably, given the foregoing, NRG would arrange a series of local meetings around the country to determine the underlying need for a change before devoting significant resources to a proposed rule. This, together with a clear definition of the underlying purpose of the proposal, will allow a more effective rule to be produced.

• l)QCKET NUMBER ~

PROPOSED RULE ft 33 ~

UNIVERSITY OF CALIFORNIA, LOS ANGELES ~;:;;::-,-~ (ol r:f<Si34~) UCLA BERKELEY

• DAVIS

• IRVINE

• LOS ANGELES

• RIVERSIDE

• SAN DIEGO

• SAN FRANCISCO SANTA BARBARA SANTACRUZ "97 UCLA SCHOOL OF MEDICINE January 24, 1997 OFF ICF Or SE CR[ Ti1 Rv HARaoR - ucLA MEDICAL cENTER

-rI,.I"',.. ., ..: ,. [) -:, E~ DEPARTMENT OOC Kl 1n l, ~ .::i cr, ,,J

• f* oF RADIOLOGY IOOOCARSONSTREET BR/), Nf: tJ TORRANCE, CALIFORNIA 90509 John Hoyle, secretary PHONE: (310) 222- 2845 Nuclear Regulatory commission FAX: (310) 533-7159 Washington, DC 20555-0001 EMAIL: MARCUS@AFP76.HUMC.EDU Attention: Docketing and service Branch Re: Fed. Reg. 61(221), 14 Nov. 96, pp. 58346-58353:

Specific Domestic Licenses of Broad Scope for Byproduct Material, ANPR.

Dear Sir:

I wish to oppose this ANPR in its entirety. It is evident that tho se r e sponsible fo r it h ave no med ical competence, do not understand medical research program activities, have no conception of the meaning of the NAS-IOM Report of 14 Dec. 95, are completely out of touch with the direction of change needed desperately in NRC's "Medical" Program, and appear to be doing little more than inventing mischievous "busy work" with which to justify their existence.

The NRC is the only federal agency that employs people to do nothing but write regulations. Good or bad, needed or not, the onslaught of regulations flows without any valid consideration of whether the regulations are needed, what they need to accomplish, and whether or not the people writing them have any respectable competence to write them. The President and the Congress are trying to stop unnecessary, burdensome regulation. One way to achieve this is to unbudget people who are paid only to create new regulations. I recommend that NRC discontinue the Office of Regulatory Research (ORR). The medical and academic licensees are suffering terribly because of the complete failure of these employees in the medical and academic areas.

The Commissioners of NRC should honor the opinions of its ACMUI.

However, NRC essentially ignores its qualified professional advice. Attached is a recent letter from one of the ACMUI experts to Larry camper, complaining bitterly about this situation. When I was an ACMUI member, I submitted similar correspondence. NRC's response was to tell me it was a "conflict of interest" for me to write to members of the commission and then to any employee of NRC. NRC will go to any length to avoid hearing an expert tell it the truth it does not wish to hear.

The NRC spent $1.25 million of our User Fee money to ask the NAS-IOM for expert advice, and has ignored all of it for the past 13 months. It is going in the opposite direction.

BOYLt'7.CIM.NIC

~ 3 0 199:-

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i-.5. NUCLEAR REGULATORY COMM1S::,1urt DOCKETING & SERVICE SECTION OFFICE OF THE SECRET.A.RV OF THE CO: *iWSSIOf~

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January 24, 1997 John Hoyle, Secretary Page on 6 Jan. 97, the 0MB disallowed a huge recordkeeping burden that jeopardized patient confidentiality and interfered with or contradicted the best medical judgment of physicians. The 0MB statement is attached. It will profoundly change the NRC program because it refers to all of 10 CFR Part 35. It is the logical step consistent with the NAS-IOM advice, the ACMUI advice, the SNM advice, the ACNP advice, and the AMA advice. What

.intellectual "heavy hitters" can NRC produce to challenge the credentials of these medical experts?

Having given a general opinion as to the overall lack of value of NRC's ANPR, I wish to specifically answer the eleven questions posed by NRC:

(1) Should the responsibilities of licensee management be specified in Part 33?

Absolutely not. While no a~tual changes in management behavior would occur, this would simply give NRC an opportunity to issue violations tor what "could happen", and harass licensees as is being done with the "Quality Management" Rule.

(2) Should the NRC incorporate requirements for the duties and responsibilities of the RSC and the RSC?

Absolutely not, in both cases. The RSC and RSC know their duties, and such NRC busywork can only lead to NRC mischief.

Most RSC and RSC activities do not involve byproduct material, and NRC does not even understand many of the areas over which it has no statutory authority. It does not even understand much of the areas over which it has authority.

(3) Should specific minimum training and experience criteria tor authorized user$ be incorporated into Part 33?

Absolutely not. The RSC and RSC are superior in judgment to the NRC in making this determination for each institution.

Education, more than training or experience, is probably the most important parameter, and NRC has never instituted any educational qualifications for any authorized users despite being highly criticized by their Advisory committee on Medical Uses of Isotopes (ACMUI) for this failing. This criticism has been ongoing for many years, and was also criticized by the NAS-IOM.

(4) Should the NRC incorporate requirements for inventory and accountability of byproduct material in use, or modify existing guidance?

BOTLJ.'11.ca.umC

January 24, 1997 John Hoyle, Secretary Page There should be no new requirements and existing ones should be relaxed. The NRC's behavior in recent years has basically been that of hysterical "atom hunters", with no intellectually respectable judgment concerning actual hazard potential.

(5) Should the NRC consider the risks associated with internal exposure pathways (e.g. ingestion, inhalation, absorption) separate from those associated with external radiation?

No, those have already been considered in 10 CFR Part 20, and repetition is completely counterproductive. Purposeful, malicious acts should not be considered here. It was not NIH's or MIT's fault that P-32 was fed to two persons. It was the fault of the criminals. Blaming the licensee is flawed logic, and seems to be an excuse for a regulatory onslaught that will in fact accomplish nothing but licensee harassment and abuse. It would cripple the ability of broad licensees to use byproduct material for peaceful uses, which is the overall purpose of the Atomic Energy Act.

The outlandish and fraudulent accusations of ignorant and vicious NRC staff and management concerning the NIH P-32 affair have been delightfully crushed by the NIH. The Commissioners should really be asking why its own staff and management obstructed the search for the criminal perpetrator. Justifying this ANPR on the basis of purposely concocted NRC rubbish is intellectually disgusting.

(6) Are there other specific aspects of the draft Regulatory Guide DG-0005 that should be codified in Part 33?

No. None are needed or of value. Flexibility, not arbitrary management organization charts, reporting paths, flow of authority, definition of management responsibilities for oversight of radiation safety programs, statement of authority of the RSC to oversee the licensed program and its responsibility for control and direction of the radiation safety program and the RSO, or training and experience criteria for the RSO should be defined by NRC regulation.

All of this gives the clear impression of an NRC goal of total megalomaniacal control over all aspects of a licensee's activities. This is bad for two principal reasons. First, it will paralyze many valuable activities performed by the broad scope licensee. Unlike NRC's "Medical" Section or its ORR, broad licensees actually make valuable contributions to our nation.

Second, these licensees have far more education, experience, and high level specialized knowledge than does the NRC.

IIOTLlff,CD(!O.C

January 24, 1997 John Hoyle, Secretary Page Draft NUREG-1516 demonstrates clearly that NRC lacks any competent understanding of the appropriate management of byproduct material by medical licensees, and the ACMUI was severely critical of this document, which was never adequately repaired. The Commissioners should review the ACMUI comments and written submissions of its members.

We cannot permit such a poor quality document to be taken seriously, and we cannot permit such gross misconceptions of medical management to be imposed on professionals whose knowledge far exceeds that of the two NRC employees who actually wrote nearly the entire document. The apparent authorship is misleading and inaccurate and the references were an afterthought created by a contract with Brookhaven to produce false "references".

(7) Would broad scope licensees be allowed to make changes in their Radiation Safety Program similar to those authorized for production and utilization facilities under Section 50.59?

No, because such prescriptive licenses should not have been issued in the first place. Broad licenses in California provide great flexibility to the licensee already. Perhaps NRC should learn from California, and then take it even further.

A broad licensed medical licensee is nothing whatever like a nuclear power plant, has nothing in common with a nuclear power plant, and despises the nonsensical prescriptive regulation of nuclear power plants. We want what the NAS-IOM told NRC to create. A removal of prescriptive regulation, and merely a requirement to conduct activities within the standards of 10 CFR Part 20. Most of the recordkeeping requirements make little sense for our type of facility, which is why the NAS-IOM recommended that they be lifted.

The NRC staff and management that created this ANPR have either not comprehended the advice of the experts at the NAS-IOM, or are ignoring it.

(8) Should the different types of broad licenses currently in Part 33 (Types A, B, and C) be deleted and replaced with a single type?

No. The entire licensing scheme of the NRC should be completely deleted and replaced only with Part 20 standards and a requirement for medical professionals (physicians, pharmacists, dentists, veterinarians, medical physicists) to have evidence of mastery at the graduate university level of basic nuclear and radiation OOTL1'7 CIIOII..C

January 24, 1997 John Hoyle, Secretary Page -s-sciences, along with ample experience for trustworthy handling of radioactive materials.

(9) Should a category for "Master Materials Licenses" be incorporated into Part 33 with the respective necessary requirements?

No, at least not at this time. First, the NRC should accomplish the licensing changes described in answer to question (8). It is questionable whether Master Materials Licenses would even make sense at that point.

(10) Should requirements for "Multi-site Facilities" be codified in Part 33 or should this be defined only in 10 CFR Part 30?

It is fine as is in Part 30. NRC should stop trying to create unnecessary work for itself which our licensees must subsidize with absurdly high User Fees.

(11) What balance should be maintained between a performance-based and a prescriptive approach to regulating Broad Scope Licensees?

None. First, the term "performance-based regulation" is an oxymoron. A "performance based regulation", such as the contemptible "Quality Management" Rule, is a prescriptive regulation.

Second, we should do away with all prescriptive regulation, by whatever name. A "performance standard" is the only appropriate regulatory mechanism, but it requires a much higher level of scientific competence than resides at the NRC at present. It requires the competence found in a broad scope licensee. It would require judgment that actual practices would keep airborne emissions, waterborne emissions, general public doses, and worker doses within acceptable limits.

Instead of NRC's present policy of inspecting mountains of paper, an occasional inspection would only involve observation of practices. NRC would have to contract out such inspections to knowledgeable professionals in ACNP, SNM, AAPM, APhA, ACR, ACMP, and HPS, because such inspectors are not employed by NRC. This would permit NRC to unbudget numerous employees and save a great deal of money.

HOTL1P7.CULlCllC

January 24, 1997 John Hoyle, Secretary Page CONCLUSION For the above reasons, I oppose the entire effort proposed in this ANPR.

In addition, I firmly support the concepts of the NAS-IOM, and believe that NRC has failed to meet any of the goals recommended in the NAS-IOM's 14 Dec. 95 report.

I believe that any and all rewriting of medical regulations should exclude NRC staff and management, and include the ACMUI and representatives of the knowledgeable medical professional societies using byproduct material. Otherwise, this disastrous regulatory morass will continue to worsen, not improve.

Sincerely,

~

carols. Marcus, Ph.D., M.D.

Director, NUolear Med. outpt. Clinic and Professor of Radiological Sciences, UCLA co: Chairman Shirley Ann Jackson Commissioner Greta J. Dicus Commissioner Nils J. Diaz Commissioner Kenneth c. Rodgers Commissioner Edward McGaffigan Hugh Thompson, Jr., Deputy EDO Edward Jordan, Deputy EDO IIOTLU'l.cllUIIC

Addendum I: Letter from Asst. Dean Dennis P. Swanson to Larry Camper.

IIOYLU7.cD<JOIC 7

&} University of Pittsburgh Helilth Samas 219 ,.,..8artcan Annu o'o .....IC. alt CTHara Sll9el Rllliiuaiw !>nlg Ruu,yl, ~ (RDRC) Plalburgh. PA 1!12t:,

HtmuRI Ust S~~ SllfnJ Com>>dttt~ (HUSC) 41~7-7M4

]amJary 10. 1997 I.any W. Camper, Branch Cme£ Medical. Acadmnic, and Commercial Use Safety Branch U.S. Nuclear Reguiarory Coi:nmissioo SFS Two Flint North Washington. DC 20555

Dear Mr. Camper:

I am writing to express my continued frustration regarding the appropriateness of current interac:tiom between the Advisory Comm.iucc on the Medical Use of lsolopes (ACMUl) and the Nuclear Regulatory Commission (NRC). This feeling was recently

.imemificd widJ. me November 14. 1996. publlcadon Cfederal Reamer, Volume 61. Number 221. pp. 58346-58353) of the NRC*s advmcc notice of proposed ru.l.emak.i1lg (ANPR) diiected a.c specific domestic licenses of broad scope for byproduct material. As you arc aware, the ACMUI reviewed a draft of this ANPR t.t its May 3. 1996, meetillg. Among other re("..nromtmdations, the ACMUI advised strongly dl2I ANPR wording which linked thr; basis for dii.s pr0pO$Cd rulemaldng with the intcmal comarnimtion cvcrus at Nili and '.MIT sbould be removed (.sec Appendix, transcript of May 3, 1996, ACMUI meeting). It is noted.

ttowever. that in the published ANPR this wording is only minimally changed from the: draft and, in &ct. additional .refercnce5 to these mtcmal contamina!ion evcms were added (e.g .* see ANPR; Summary and II. Requests for Commenrs on Ge.ncnl Considerations, question 5).

Further RYiew at the published ANPR. reveals that other xeco.i1111k:Gdatiom {e.g., .specifically addrc,,ing tcaaons for me omission of draft language. ~ differences/controlling language between 10 CFR and Pan 35) of me ACMUI were also not addressed. This situation follows the NRC's disregard of the ACMUl'a concems relat.ed to sweinenu {i.e.*

information that must be provided to breast-feed.in& patkmts) comained. wiJhin the patient release role (see tu1lSC1~ of Novmnbcr IS, 1996, ACMUI meeting).

1 feel that I and the other members of the ACMUI strive to undctmnd the concerns underlyina the ruk:making efforts of the NRC and w provide our best advice on how to be,t present 1:bcse CODCe.n1$ to the regulated community. I clearly ICCOgnizc that the ACMUI serves, only in an advisocy capacity to NllC m.ff. Howovcr, I feel dw. in accordance with standards of professional courtesy and respect. the ACMUI should be provided with a nodflcalion mi explanations for NRC decisions tO disupss its specific recommendations. As pet" me request I made at the November 15, 1996, ACMUI meeting, the ACMUI should also T, trmfo, 11tillg tbe Prt#J1t- Di1Cf1Ming tbc Ftmn"t

J.

• Larry W. Camper, Branch Chief Jamwy 10, 1997 Page2 be clearly informed of how its ~mendations are reviewed wi,Wiu mt nrr;mi-rnrirm1l

.&..~v ul d!e !fl.~ a.nu 11 wnat level, and by what process. itS specific I'CCOillJllenda ma.y be rejeaed..

FiDally. ~ n - w i t h the NRC's recent str.ucgic planning mitiad.vcs, me Commimoners have recommended that tho medical use of byproduct materials continue to be rcgu]a.te'1 as curre.mly wirh improved efficiencies and a move to more performance-based regulations based on a risk assessment Wllh regard to risk level determinations, the Q\romissioDCtS have iDdk:ated that input of the ACMUI should be actively sought.

Unfonww.ely, based on current (vida supra) and past (e.g., Quality Management Rule) actions of me NRC, I remain uncom1Dced nm such advice provided by the ACMUI will in fact be incorporated into futon revisions of tho rcgula.ti0D$; thus ffl11king u ve:ry difficult for me to be supponive of the Comm.issionffl' recommendations.

cc: Judith Stitt. M.D.

. _ArfENDIXA Jli.l'f'"ll-:H rKJ lj,q/ 1:H unt.lJ Hi HL 1tru rHX NU. 4 lc M, roou t'. m, 1 not: there's a possible need for claritication and/or 2 il.'.l.corporation ot t:he guidance. .And t.his was ra.ised agai 3 following the two reeent incidencs lase year which I knc 4 you've heard about boch at NIH and MIT, and the?:e was sc s discussion abou~ ac your last meeting.

6 One of the major questions that we're looki~

7 ac is whache.r or not it should be a broad performance 8 ba&ed regulation with clarificat:ion of objectives versus 9 codifying specific requirements that ,u:e currently 10 contained i~ the guidance. And as Dr~ 'Siegel men~ioned, 11 in the license condicions on broad scope licenses.

I

• 1.2 13 here.

MEMBER SWANSON: Let. me make a comment righ*

As you present the background here and as I read l 14 15 the background from the draft, ic refers conside~ably ~:

Lhe incident5 t:.f\..at happened with the P-*32 concaminac.ion 16 And again, chis goes back to our previ~us conversations 17 about regulacion by the yo-yo effecc.

le And I would really advise that in your 19 background sec~ion that you re.'llOve ~ much as possible 2C developing these -- or this proposed rule based upon th 21 incidents. Becaus;e now, I really don'~ think -- if yo~

22 going t.o develop this or you' re going t.o make these 23 changes, let them s~and on what you just said, not base 24 upon these incidents, 25 Because tha~*clearly indicates regulacion t NEAL R. GROSS COURT R90RTERS A N D ~

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l:l lUntU 1lJflL Hili rHX NU, 4lt b4f fbbU t'. Ub l the yo-yo eff~~t. and I think y-ou really need co 2 deemph~size thac as much as possible.

3 CHAIRMAN SIEGEL: As we heard John Glenn make 4 his presentacion last time and based upon what we've been 5 able to read, the notion thaL insufficient tnanagement 6 oversight may have contributed to ehe evencs at MIT and 7 the NIH strikes us as a -- serikes me as a hypothesis and 8 not as a documented fact.

9 And if you*r~ going to use that as the major 10 argume..~t for rebuilding Pan 33, then I think you need a 11 more crieical analysis of the information ehat you h~ve in 12 hand. I mean, ehae really is -- strikes me as reacting to 13 single low probabilicy ~~nes that may be bey~nd anyone's

• 14 control, and ~hen completely redo a set of regulations.

And thae is government by yo-yo if evar I 15 defined it at the lase meeting. Now, that dce5n'~ mean 17 thac we rebuilding Part 33 is a bad idea, because i~ may l8 well be an excellent idea. But I'm not sure that you've l9 t':'l.ade a good c~se for it based on thQ P-32, and I'd love ~o 20 I hear what Carl has to say abouc chac. But 21 OR. PAPER!E.LLO: could I make an observation?

2:2 CHAIRMAN S!EGU! Yes.

23 DR. PAPERIELLO: You're right. In fact, some 24 of the stuff -- I'm earl Paperiello, and I'm.che Director 25 of NMSS. The seeds of doing~whac we want to do in ?arc 33 NEAL R. GROSS COURT REPORT!JIIS NlO TRN-iSCRl!l!R$

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t',Uf tH Unt.V l vHL ltlli l laid dormant before the event occurred.' Th~ event did 2 ide~cify some weaknesses in managemene control and 3 ma~agement of a feeling on who was responsible !or cetta; 4 ch.i:igs.

S Not in the evencs chemselves, but in things S chat we found going on at ~he instiLution.s when wa did tr 7 inspsctions. -But in my management review-of the medical 8 program, ! poineed out thae Part 33 really doesn'c puc tc 9 many requirements on the radiation sa~ecy officer or the l0 committee. Not what the practice is. The words in the 11 recurrene rule say you're going co have a commitcee a...,d 12 they're going to meet periodically with the RSO a..nd chey 13 don'c have co do very much ocher than approve authorized 14 use:::-.

15 And you're going to have a., RSO ~hat's 15 available for consuleation. It really doesn't have a 17 syscem where I think our expectations right new are.

18 Certainly they've evolved to this over the years -- is 19 that the radia~ion safecy officer ensw:es the inscitutio*

20 is mee~ing the requirements and the radiation safety 21 commi~tee is ensuring the radiation safety officer is 22 doing, you know, chat person's job.

23 Coupled with that, in the BPR eha.~ we did, w 24 mad* a recommendation eo che commission and the commissi 25 approved that for broad scope licensees; chat they have NEAL R. GROSS COURT REPORTERS ANO TRANSCRISE1tS 1323 RH00£ ISL.AHO AVE.. N.W.

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JHJ'i- 11-::H t'l':J ! j ; qt:1 tl 1Uflt.U 1liHL uru rH.1\ NU. q1~ oq1 /OOU

t. 19 1 the same kind of freedom that our reactor licensees have, 2 and that is to change procedures that now r~quir* an 3 amendment won't require an amendment.

4 So lee me t~ll you the model I'm trying to get 5 to. bd even -- and that i~ chis. We'r~ going to give 6 broad scope lic~nsees -- and you know, chis reflec~s the 7 fact that w~n~w have over the lase 20 years developed a 8 large infrastructure of certified healeh physicists, 9 medical physicists, a whole trained body of professionals, 10 text books on how to do this stuff.

11 So look, institution, you are responsibl~ for 12 getting from point~ to point B, and we're going to give 13 you that freedom. Okay, so that is yeah, we a?:"e

~4 we're goir.g co give I doa't want to get into wher~ we is a~e now. We prescri~ how you do a beta analysis. I can 16 chink of five diff~rent ways off the top of my head of 17 countir.g a beca ray, and I think mos~ you inst:.icui::ions.

18 may h~v~ enough equipm~nt to do three or four of them.

I don't need to specify that in the license.

20 1 In cc.her words, I'm and tb.at's kind of the goal of this 21 whole thing is t:.o give people t:.he freedom to run their 22 program. But recognize, you have it. And there's 23 somebody in concrol of che program.

ion 24 CHAIRMAN SIEGEL: And I completely agree with 25 evcry~hing you ju$e said. Sue then I'm .till no~ sur~ wr.y NEAL R. GROSS COURT RE?ORTERS ANO TRANSCRl8E.RS 1323 RHODE !Su.NO AVE.. N.W.

(202)234-4433 WASHINGTON. 0.C.. 20005-3701

JAN-lf-l:l( H!l 1;;:ou l:H !:)MtU 1(.;AL llili I' AX NU,. 4lc t54 f fOtlU "l

2 l you're claiming ycu':re doing ic. in part beeause of NIH anc 2 MIT. Tha~'S che link --

3 DR. PAl?ERIELLO; I understand.

4 CHAIRMAN SI.EGEL: In a way, you're diseorting s your own credibility by saying that'& the reason.

6 DR. PAPERIELLO: I understand.

7 - CHAIRMAN SIEGEL: And what I'm doing is e advising you noc to shoot yourself in the foot, ~t leas~

9 in my percepcion.

10 MEMBER BROWN: You mentioned single and 11 probable events ac. MIT and N!R. Aren't we adding Wilkes 12 Barre as well?

l3 CHAIRMAN SIEGEL: What?

14 MEMBER BROWN: Aren'c we -adding Wilkes-Ba:=e l5 Pennsylvania to the lisc as well?

16 CliAIRMAN sr:c:Ga: They don't have a broad 17 license probably, but --

18 DR. PAPERIELLO; For somehow, the Jack 19 Anderson column I think completely misrepresented that 20 event. From eve~hing we know, thac was an accident t 21 was observed. The technologist -- it was student 22 technologis~ who worked with very high specific activit 23 ~lution from a generator, and she dropped a syringe.

24 ocher words, it wu an-accident.

25 There was no deliberace there was a NEAL R. GROSS COURT R90AT!RS AND TRANSCRIBERS 1 ~ RHODE ISl.AND AVE.. N.W.

WAlltWfN(.;T(")N n t'! ~ /202l234-4':

t! l UntU l l,;HL l lili rttX NU. 41Z b4f fbbU r. w

. ' b

,. ,. 21 l newspap~r column thac implied there was a deliberace 2 dosing. It was not a deliberate dosing. Our 3 investigation sho~s chat i t was an accident. I mean, it 4 wasn't good. But you know, I'm just saying i~ w~sn't 5 no, ic wasn't something -- you know, the individual was a 6 student and they dropped the syringe.

7 OCll:.IRMAN S.IEGEL ~ Okay, go ahead.

8 DR. HOLAHAN: Okay, what I'd like to do now is 9 walk you chrough some of the quescions that are in the lO drafc ANPR and a..sk for sore of you co comment on ~hose 11 questions, but also if you have other guQstion. or you 12 feel that we're not agking the right question, comment on 13 .:hose coo.

M£MB-='R GR.A..~"!; A point: of clarification. Do

6 we know how many broad scope licenses the~e are by li category, and are they discributed ac major teaching 18 centers or -- I'd like some feel of what we're talking 19 about.

20 DR. HOLAHAN: There's approximacely 120 NRC 21 ~road scope licenses today. So if we chen include the 22 agreement states, chat would be a lit~le over 300 or so 23 total broad scope licensees in the country. The majo~ity 24 of those are all ~he Type A broad scope9. I don'c have a 25 number on how m~DY Type Band Type c broads we have.

NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISl.AN0 AVE.. N.W.

{202)23,&-4433 WASH!NGTON. 0.C. 20006-3701 (202123,t,-4433

Addendum II: 0MB statement of 6 Jan. 97 concerning 10 CFR Part 35.

IIOTL.1'7.0?aUO.C 8

Page 2 Nuclear Licensing Reports January 1997 0MB APPROVES CONTINUED USE OF 10 CFR PART 35 The Office ofManagement and Bud_get on Janu~ 6, 1997, approved, pursuant to the Paperwork Reduction Act, ttie information collection ~entsin 10 CFRPart 35, Medical Use ofByproduct Material. The new approval is effective until January 31, 2000.

In approving Part 35, 0MB' sDonald R Arbuclde, Deputy AdministratorofOMB 's Office oflnformat1on and Regulatory Aflairs. provided as terms ofthe clearance that:

"NRC shall assure that the information required by paragraph (c) is collected in a way that assures that confidential patient information is not traceaole or attributable to specific patients.

Further; NRC shall assure that licensee recordkeeping is conducted in a manner that assures patients confidentiality, such as byretainingdata in a central file without a record or cross-reference to ~ecific J?&tient files. These information collection and recordkeeping requirements are approved solely for the purpose ofverifying that licensees have proper proceoures in place for assessing potential third-party e~sure associated with and arising from exposure to patients administered radioactive material. Further, these new requirements are approved onl:v.to the extent thatt!leY do not interfere with or contradict the best medical judgement of physicians. S_peciflcally, the requirement that licensees provide written instructions to lactating patients shall not be used to specify the content ofinstructions and recommendations in a way that mterferes with the discretion and juagement oft he phyajcian. 0MB expects that NRC will provide it with the relevant regulatory guidance before it is made public (potentially Spring, 199,) so that 0MB can ensure that the guidance is consistent with tbePRA and with the terms ofthis approval."

In a December 2, 1996. letter to 0MB, Dr. Carol S. Marcus, Director, Nuclear Medicine Ol!fpatient Clinic, Harbor-UCLA Medical Center, and President oftheCalifomia Chapter ofthe ACNP, <?P.POSed the recordkeeping requirements- of Part 35 and argued strongly for patient confidentialrty.

I '

DOCKETED

(!)

US~1RC THE UNIVERSITY OF SOUTH CAROLINA

'96 O[: -2 P3 :21 Radiation Safety 306 Benson School oFF Iu -. - g 1iri;n1f -. * ~ os DO CKE f,, - r* ~ ~BP;)~ ~ ~;i69 fl hJ.-. *: ,-'.

November 27, 1996 John C. Hoyle, Secretary U.S. Nuclear Regulatory Commission Washington, D.C. 20555-0001

Dear Mr. Hoyle:

I would like to offer some comments with respect to the proposed rule making of 10 CFR Part 33. In reference to the draft text of 33.2: "Management means the chief executive officer (or equivalent) or the person's delegate or delegates.",

I see a loophole that makes the effort to define management's relationship to the radiation safety program a meaningless exercise. In the case of academic broad licenses, you must define very clearly who is considered management; ie. the president, the provost or an individual at the level of vice president (perhaps research, administration, business and finance). To allow an administration the wiggle room to go any lower in the management chain seriously weakens the program. I have observed many radiation safety programs at academic institutions in the Southeast that are ineffective because management has not placed them in a strong enough administrative position. In my opinion, they should be forced to do so by regulation.

I have struggled with this issue at my institution for the past several years. With the assistance of our radiation safety committee, we have tried to educate the administration that the radiation safety officer, in order to be effective, must have a direct line of communication with senior management. The administration treated this proposal with a certain degree of hostility and named the health and safety director and the director of business affairs as senior management. The problem with this decision is that the health and safety director has never met with the president of the university and the director of business affairs is several layers of management below the chief executive officer. This arrangement is a sham and, in my opinion, is not what the Commission would view as ideal management oversight. JA Acnwledged bv card .....~** ~..  :!.~~~ b USC Aiken

• USC Beaufort

• USC Coastal Carolina

• USC Columbia

• USC Lancaster

• USC Salkehatchie

• USC Spartanburg

• USC Sumter

• USC Union An Affinm:r1ve Action/ Eqwi l Opportunity lrutiNtion

CJ.S. 'UCI. ~ .,.-. ; -: t; TCRY COMMISSIUl't DO < * -.- .;_ 'AV!CE SECTION OFr, *~ *

• i-Jt SECRETARY Or . *~L CO ,,MISSION

fostma~ Da *. t-/ 1-1 /Cf 6 Co~s Ace* , - -~ /

I hope that the Commission will seriously consider a rewording of paragraph 33.2 so that there will be no misunderstanding of what it considers appropriate concerning this matter.

For years, academic radiation safety programs have been struggling to be taken seriously by their management but the efforts have been frustrated by having no clearly defined regulations to help us in this area.

Your consideration of this proposal wi ll be greatly appreciated.

If this comment is to be published, please do not use my name or institution.

Sincerely, o1tM\l,;;6h.D.

Director, Radiation Safety

\j~

[7590-01-PJ NUCLEAR REGULATORY COMMISSION DOCKET NUMBER 1111 ')- 10 CFR Part 33 DOCKElED PROPOSED RULE rn  :;; 3 - RIN 3150 - AF54 l'SHRS (bl FR sn '1SPECIFIC 6)

DOMESTIC LICENSES OF BROAD SCOPE FOR *% NO' 13 Al 1 :35 BYPRODUCT MATERIAL AGENCY: Nuclear Regulatory Commission.

ACTION: Advance Notice of Proposed Rulemaking.

SUMMARY

The Nuclear Regulatory Commission (NRC) is considering amending its regulations governing specific licenses of broad scope for byproduct material to clarify the regulatory and health and safety basis of current licensing practices and to provide licensees with the flexibility to make certain types of changes to their radiation safety programs. Currently , the regulations do not contain a clear description of the duties and responsibilities of management. the Radiation Safety Officer (RSO) or the Radiation Safety Committee (RSC). In addition to various ongoing staff efforts regarding the possible need for clarification of requirements for broad scope licensees.

consideration of changes to the regulations was also a recommendation of the Incident Investigation Team reviewing a recent incident involving ingestion of phosphorus-32 at a broad scope facility . The NRC is evaluating. for possible codification in its regulations. existing regulations and appropriate requirements derived from prior guidance and license standard review plans with reference to : management oversight of broad-scope licensed programs: the role of the RSO: the responsibilities of the RSC: supervision: the qualifications of the authorized user: the use of audits and inventory requirements: and security and control of licensed material. The NRC is seeking comments and suggestions on possible revisions.

"J./ ,,.,, ,

DATE: Comment period expires (-4-Asert 99 clays after p~blicstion~. Comments received after this date will be considered if it is practical to do so. but the NRC is able to ensure consideration only for comments received on or before this date.

ADDRESSES: Send written comments and suggestions to: Secretary, Nuclea r Regulatory Commission. Washington. DC 20555 -0001. Attention : Docketing and Service Branch. Hand-deliver comments to : 11555 Rockville Pike. Rockville.

MD. between 7:45 a.m. -and 4:15 p.m.. Federal workdays.

FOR FURTHER INFORMATION . CONTACT : Patricia K. Holahan . Ph .D.. Office of Nuclear Material Safety and Safeguards . Nuclear Regulatory Commission .

Washington. DC 20555-0001 . telephone (301) 415-8125. e-mail PKH@NRC .GOV .

SUPPLEMENTARY INFORMATION :

I . Background The regulations for specific licenses of broad scope for byproduct material are codified in 10 CFR Part 33. This part was initially published on June 26. 1965. and became effective on August 8. 1965. Its provisions are applicable to licenses for multiple quantities and types of byproduct material . There are three types of broad scope licenses. currently described in Part 33. that authorize the receipt. acquisition. ownership . possession.

use. transfer. and import of byproduct material for purposes authorized by the Atomic Energy Act. as amended. A "Type A specific license of broad scope" usually authorizes quantities in the multicurie range for radionuclides with a range of atomic numbers . The possession limit for a "Type B spec1fic license of broad scope" for a single radionuclide is the quantity specified in Column I of Schedule A to Part 33. If two or more radionuclides are possessed. a sum of the ratios test is performed to determine possession quantities .

Similarly. the possession limit for a "Type C specific license of broad scope" for a single radionuclide is the quantity specified in Column II of Schedule A to Part 33 . In general. the possession limits are progressively smaller as the Type changes from A to B to C.

e Each type of specific license of broad scope has a condition regarding individuals who may use or directly supervise other individuals who use byproduct material. Material possessed under a Type A specific license of broad scope may only be used by. or under the direct supervision of .

individuals approved by the licensee ' s RSC. Material possessed under a Type B specific license of broad scope may only be used by, or under the direct supervision of. individuals approved by the licensee's RSO . Material possessed under a Type C specific license of broad scope may only be used by ,

or under the direct-supervision of . individuals who satisfy the education and training requirements specified in 10 CFP- 33 .15 .

2

In practice. Part 33 reduces the administrative burden for both licensees and the Commission without reducing safety standards or lessening the licensing requirements for training, experience. facilities, and equipment. Both the NRC and the licensee benefit from the reduction in license amendments that might otherwise be needed to change authorized radionuclides, quantities. or names of individuals who may use, or supervise the use of. byproduct material. The provisions of Part 33 recognize that certain licensees. who conduct varied and large-scale activities with licensed material under oversight by persons with extensive training and experience in -*

radiation safety, do not require the same degree of regulatory oversight as do licensees who perform similar or less complex activities with licensed material. but have less comprehensive radiation safety programs. Part 33 does not prescribe requirements for a radiation safety program to meet the specific needs of the licensed facility and activities. Rather, broad scope licensees develop an application addressing general requirements specified for each type of specific license of broad scope and submit this program description for the NRC to review. The commitments made by the license applicant. upon approval by the NRC. become conditions of the license by reference.

The NRC has issued guidance for preparation of applications of broad scope (Regulatory Guide 10.5, "Applications for Licenses of Broad Scope") to provide acceptable methods to ensure that licensed activities will be conducted in a safe manner. In the approximately 30 years since Part 33 was issued. this guidance was revised to address many issues that are not explicitly set forth in the regulation. For example:

CD There is no requirement for management oversight of the radiation program. including audits and specification of the responsibilities and duties of the RSC or the RSO; (2) There are no requirements in Part 33 for inventory and accountability of byproduct material in use; (3) Although these licensees may approve users and new uses of byproduct material. there is no provision to permit a specific licensee to make certain types of changes to the radiation program as described in the application (such as changing dosimetry vendors) without an amendment of the conditions of the license: and (4) There is no requirement specifying either a single location of use or multiple locations of use. Government agencies and corporations 3

with similar operations at multiple locations have sought to reduce their administrative burden and regulatory costs by centralizing their radiation safety functions and consolidating multiple single site licenses.

The NRC is considering the need to codify, as requirements. some of the licensing guidance and practices. to provide a clearer regulatory basis for evaluating whether to issue or deny licenses of broad scope and provide a clear regulatory framework within which licensees must operate.

In 1993, an internal senior management review of NRC's existing medical use regulatory program. considered needed improvements in the medical licensing and inspection programs. Additionally, the review determined that many of the significant problems identified in medical programs are a consequence of licensee management and RSO failures. The report recorrmended that current NRC requirements and guidance on the responsibilities of RSOs. at all materials facilities, should be examined with consideration given to a performance-based rule. Draft NUREG-15161 * "Management of Radioactive Material Safety Programs at Medical Facilities," was published in January 1995 for coIT111ent. in part to address this recommendation. This report describes a systematic approach for effectively managing radiation safety programs at medical facilities. It should be noted that other types of broad scope facilities such as manufacturers and research and development facilities are also being considered in this process. e Generally, 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 act~vities: For the three-year period from 1993-96 there were only 38 events involving these licenses that resulted in some type of enforcement action. However, the majority of these events involvep loss of control of the radioactive material. release of material in excess of the limits in 10 CFR 20. or contamination outside of the 1

A free single copy of draft NUREG-1516 may be requested by those considering public corrrnent by writing to the U.S. Nuclear Regulatory COTIInission. ATTN: Distribution and Mail Services Section. Room P-130A.

Washington. DC 20555. A copy is also available for inspection and/or copying in the NRC Public Document Room. 2120 L Street. NW. (Lower Level). Washington.

DC.

4

work area. These types of events, which could potentially result in doses to the public from radioactive material in unrestricted areas. are often the result of weak controls by either the RSO or RSC.

The NRC is curr2ntly developing a new materials licensing process. To proceed with the implementation of the new pr~cess. the NRC staff reco1TJTiended certain actions for Commission approval. These included the development of a standard license condition. for broad scope licensees. that is functionally equivalent to 10 CFR 50.59, for nuclear power reactor licensees. This would allow licensees to make certain types of changes to their program after review and approval by the RSC without the need for a specific license amendment.

provided that the change does not alter radiation safety performance, but is only a change in the methods to achieve that performance. This process is now being considered as part of this advance notice of proposed rulemaking.

The possible need for clarification of requirements for broad scope licensees is also supported by two recent events. of a similar nature,*

involving phosphorus-32 (P-32) internal contamination of individuals at large

,1.

biomedical research facilities. P-32 is widely used in research institutions, as are many other radionuclides. Although both of these events involved P-32, the inherent issues of control of licensed material and management of radiation safety programs extend to all facilities using licensed material.

The NRC dispatched an Augmented Inspection Team to investigate the circumstances surrounding the first incident. and an Incident Investig?tion Team to investigate the contamination incident at the second facility. The teams found, among other things, that regulatory requirements and guidance for the application of security and control of relatively small quantities of unsealed byproduct material are inconsistent. and that the roles and responsibilities of RSOs, RSCs and management are not clearly specified.

Weak management oversight of the radiation protection program was also identified as a contributing factor in one of these internal contamination events. The licensee did not use a process of management review and self-assessment (audits) to look for weaknesses in its program. and to take appropriate remedial actions. Although Part 33 requires the establishment of an RSC and the appointment of an RSO, it does not provide broad sco~e licensees with a clear description of the duties and responsibilities of the 5

RSO or the RSC. Therefore, the NRC is evaluating, for possible codification in Part 33. existing regulations and appropriate requirements derived from prior guidance and license standard review plans, with reference to:

management oversight of broad scope licensed programs; the role of the RSO; the responsibilities of the RSC; supervision; the qualifications of the authorized user; the use of audits and inventory control; and security and control of licensed material.

II. Requests for COlllllents on General Considerations The NRC has identified some areas. within Part 33, that could be modified or deleted, and is seeking comments on these as well as any other issues offered for consideration of this part. A major issue is whether the regulations should be performance-based or include some of the existing licensing guidance as specific requirements. A revised performance-based rule would clarify the obj~ctives the licensee must include within its program. but details, as to one method acceptable to the NRC staff to meet those objectives. would continue to be provided in guidance documents, such as draft Regulatory Guide DG-0005. "Applications for Licenses of Broad Scope" (second proposed Revision 2 to Regulatory Guide 10.5) issued for public comment on October 1994.

The purpose of describing these preliminary issues and posing certain questions is to illustrate aspects of NRC's evaluation of Part 33 to date, and to request public comment on the completeness of this evaluation and whether e

the proposed changes pose any serious implementation problems. Corrmenters are invited to make additional suggestions. In addition to specific questions, draft rule language is provided. for coITJTient, that reflects many of the identified issues.

1. Should the responsibilities of licensee management for the radiation safety program be specified in Part 33?

The team reviewing one of the internal contamination incidents identified weak management oversight of the Radiation Protection Program. The licensee d~d not use a process of management review and self-assessment (audits) to look for weaknesses in its program and to take appropriate 7

6

remedial actions. Draft NUREG-1516, "Management of Radioactive Material Safety Programs at Medical Facilities." discusses the importance of the role~-

of an institution's executive management including selecting the RSO.

determining adequate resources for the program. using contractual services.

conducting audits. and establishing the roles of authorized users and supervised individuals. Draft Regulatory Guide DG-0005. "Applications for Licenses of Broad Scope" (second proposed Revision 2 to Regulatory Guide 10.5) recommends that a license application for a Type A license of broad scope include an organization chart depicting the management structure, reporting paths. and flow of authority. NRC is soliciting c0111Tient on the mechanism for.

and extent to which. requirements defining management responsibilities for oversight of radiation safety programs should be included in Part 33.

2. Should the NRC incorporate requirements for the duties and responsibilities of the RSO and the RSC?

Part 33 provides broad scope licensees with neither a detailed description of the duties and responsibilities of the RSO or of the RSC nor with specific qualifications of the RSO. The RSO for a broad scope license must be sufficiently qualified to manage the day-to-day operations of the radiation safety program. Depending on the size and scope of the program. the necessary qualifications may vary for different licensees. Draft NUREG-1516 describes a systematic approach for effectively managing radiation safety programs at medical facilities by defining and emphasizing the roles of ,the institution's executive management. RSC. and RSO. Draft Regulatory Guide DG-0005 suggests that an application for a Type A license should include a statement of the authority of the RSC to oversee the licensed program and its responsibility for control and direction of the radiation safety program and the RSO. The NRC is soliciting public corrrnents on the need for specific requirements delineating the roles and responsibilities of the RSC and the RSO and the establishment of minimum training and experience criteria for the RSO.

3. Should specific minimum training and experience criteria for authorized users be incorporated into Part 33?

Currently, the requirements in §33:15 for issuance of,a Type C specific license of broad scope in~lude specific training and experience criteria for 7

individuals using byproduct material. There are no specific training and experience criteria stated in the requirements for the issuance of other types of broad scope licenses. However, Appendix J of draft Regulatory Guide DG-0005 provides guidance for elements of a broad scope training program for authorized users as well as for supervised individuals. The guidance does allow the licensee the flexibility to develop a program commensurate with potential radiological health protection problems but suggests that the training for authorized users for nonmedical use should be at least equivalent to that currently specified in §33.15(b)(l) and (2). The NRC is soliciting comment on whether training and experience criteria should be incorporated into the regulations or be addressed in guidance documents.

4. Should the NRC incorporate specific requirements for inventory and accountability of byproduct material in use. or modify its existing guidance?

The team reviewing one of the internal contamination incidents found that regulatory guidance for the security and control of small quantities of unsealed byproduct material was inconsistent. Consequently. NRC staff committed to review existing regulations, guidance. and license standard review plans. with reference to the security and control of radioactive materials. as well as the establishment of restricted. unrestricted, and controlled areas. Additionally, NRC inspectors have identified some broad scope licensees who do not adequately account for sealed sources (e.g .. PuBe sources). The NRC is soliciting comnents as to codification. in the regulations. of requirement~ regarding accounting for. and inventory of.

radioactive materials.

5. Should the NRC consider the risks associated with internal exposure pathways (e.g., ingestion. inhalation. absorption) separate from those associated with external radiation?

The two recent events discussed in the background section both dealt with ingestion of radioactive material in contrast to external exposure. In some cases. it appears that. because of the greater uncertainties associated with dose estimates for internal exposure than external. the public. some workers, and some licensees consider that greater protective measures are 8

(

necessary to minimize exposures from internal pathways. Although the C001nission recognizes that there may be greater uncertainties with the estimation of interna~ exp0sure. the revision of 10 CFR Part 20 assumes that internal and external exposure are equivalent in terms of risk. This is the underlying basis behind the total effective dose equivalent (TEDE). The NRC is soliciting comments on whether the risks from internal exposure should be considered separately from the risks from external exposure.

6. Are there other specific aspects of the draft Regulatory Guide DG-0005 that should be codified in Part 33?

In October 1994. draft Regul~tory Guide DG-0005 (second proposed Revision 2 to Regulatory Guide 10.5) was issued for public comment. This revision is substantially more comprehensive than previous guidance in identifying the information needed to complete NRC Form 313 when applying for a license of broad scope for byproduct material. It includes such aspects of the radiation safety program as administrative procedures. material inventory and accountability, audits and appraisals. safety evaluations. and exposure control. There are currently no specific requirements in 10 CFR Part 33 addressing these topics, or additional topics discussed in the guidance. The NRC is soliciting c001nents on which. if any. aspects of the draft regulatory guidance for broad scope facilities should be codified in the regulations. l

7. Should broad scope licensees be allowed to make changes in their r*

radiation safety program similar to those authorized for production and utilization facilities in §50.59?

There are no specific regulations governing changes to the radiation

---

safety program for broad scope licensees. In contrast. medical use licensees may make minor changes in their radiation safety procedures described in an application for license .. renewal. or amendment. that are not potentially important to safety, pursuant to §35.31. Nuclear power reactor licensees may make changes in the facility or procedures as described in the safety analysis report (SAR) or conduct tests or experiments not described in the SAR. without prior Commission approval, unless the proposed change, test. or experiment involves a change in the technical specifications of the license or an unreviewed safetyI question. The licensee must maintain a written safety 9

evaluation of the change. Although an unreviewed safety question. as defined in §50.2. is not applicable to materials licensees. §36.53(c) for irradiator licensees. allows licensees to revise operating and emergency procedures.

provided. in part that any changes should not reduce the safety of the facility. The NRC i-s soliciting cOlllllents on allowing broad scope licensees to have the flexibility to make changes to their radiation safety program as is afforded to irradiator and nuclear power licensees.

8. Should the different types of broad scope licenses currently in Part 33 (Types A. B. and C) be deleted and replaced with a single type?

The current NRC regulation 10 CFR Part 33. "Specific Domestic Licenses of Broad Scope for Byproduct Material," provides for three distinct types of licenses of broad scope (i.e .. Type A. Type B. and Type C). which are defined in §33.11. There is no difference in the fees associated with each of the three types of broad scope license. for a specific category of license (e.g ..

manufacturer. research and development. medical. etc.). As the majority (approximately 240) of NRC licenses of broad scope are Type A. NRC is considering the elimination of Types Band C. The activities previously authorized as a Type B or C license of broad scope (approximately 60 licenses) would be conducted under a specific license of limited scope or the licensee could modify ,ts program to meet the requirements for a Type A specific license of broad scope and commit to the necessary program oversight and use of a RSC. The NRC is soliciting comments on whether to eliminate Types Band C specific licenses of broad scope.

9. Should a category for "master materials licenses" be incorporated into Part 33 with the respective necessary requirements?

The NRC currently has issued a single master materials license" to each of three federal departments. the U.S. Navy, Air Force. and Department of Agriculture. A "master material license" authorizes a single entity to issue permits for its facilities at multiple sites in multiple regions. The NRC does not review or approve new users and/or locations before use. and does not inspect each of the permitted facilities under the routine inspection frequency for that type of facility. Unlike NRC inspection of othe, multi-site broad scope licenses. the NRC inspects a sample of master materials 10

facilities each year. These licensees are inspected less frequently because they conduct inspections of their permittees. These licensees are not permitted to authorize releases of byproduct material to the environment nor grant exemptions to NRC's regulations. without prior NRC approval. To date.

the master materials program has worked well and could serve as a model for external regulation of some DOE activities. The scope of authority and conditions in this type of license and the requirements imposed on these licensees have not been subjected to the public coITTTient process. The NRC 1s considering whether specific requirements for issuance of a master materials license should be codified in Part 33. The draft language includes a definition for a master materials license. but does not include any distinct requirements. The NRC is soliciting cormnents on this issue.

10. Should requirements for "multi-site facilities" be codified in Part 33 or should this be defined only in JO CFR Part 30?

A multi-site license is one that includes two or more locations* or use-identified in the license. such as: (1) stand-alone facilities that would otherwise be licensed individually; or (2) satellite facilities that are not located within the principal job site. and for which NRC licensed material use is ongoing (excluding temporary job sites. broad scope licensees. or mobile nuclear medicine services). A multi-site facility may also include those licensees for which the addresses of use are geographically separated and which may each be under the direction of the same or different RSO(s).

Regardless of the number of sites authorized under one license or the geographic distance between sites. the adequacy of the overall radiation safety management structure must be reviewed by the licensee and the NRC to ensure safe operations at each site.

Although there are many aspects of a multi-site license that require licensee commitments similar to those made by broad scope licensees. they may not meet all the criteria in 10 CFR 33.13 for issuance of a Type A specific license of broad scope. For example. a multi-site licensee must have a management structure to ensure adequate control and conduct of the program.

but may not have the expertise or need for the degree of flexibility given to broad scope licensee~. Therefore. alt~Jugh some multi-site licensees may meet

the requirements for a broad scope license. many would continue to be limited 11

specific licenses. The NRC is soliciting comments on whether a separate category for multi-site licenses should be included within Part 33 with corrrnensurate requirements for licensing, or if a multi-site license should be defined in Part 30 with specific requirements. as necessary, for management controls.

11. What balance should be maintained between a performance-based and a prescriptive approach to regulating broad scope licensees?

The Commission is considering improvements to increase efficiency and the need to revise regulations to be more risk-informed and performance-based rather than prescriptive. Currently, many of NRC's regulations are a combination of performance-based and prescriptive. The occupational dose limits specified in §20.1201 and the requirement for a radiation protection e

program pursuant to §20.1101. are examples of performance-based regulations.

whereas the requirements for training for radiographers specified in §34 31 is an example of a prescriptive regulation. The staff considers that a risk-informed, performance-based regulatory approach should have at least four key elements: 1) there are measurable or calculable parameters to monitor licensee performance; 2) objective criteria are established to assess performance; 3) licensee has the flexibility to determine how to meet established performance criteria: and 4) failure to meet a performance criterion will not have an intolerable outcome. The NRC is specifically soliciting comments associated with those provisions where a performance-based approach would be satisfactory to accomplish the purposes of the Atomic Energy Act of 1974. as amended. and where more prescriptive requirements are necessary to provide appropriate safety.

III. Request for Regulatory Analysis Information If a change of requirements is needed. the NRC will prepare a regulatory analysis to support any proposed or final rule. The analysis will examine the costs and benefits of regulatory alternatives available to the Commission.

The NRC requests public corrnnent on costs and benefits. normal business practices. new trends. and other information that should be tonsidered in the 12

regulatory analysis. Cooments may be submitted as indicated in the ADDRESSES heading.

IV. Specific Examples of Possible Regulatory Language The NRC's review of Part 33 was. discussed at the All-Agreement State meeting in October 1995. At that time. representatives from the State of Illinois indicated that- they were reviewing

- ~ -

their existing regulations for broad scope licenses and provided draft language to the NRC. Therefore, the NRC. in partnership with the State of Illinois. has developed language that may be applicable to a revision of Part 33. This draft text reflects many of the issues as described. The NRC solicits conments on the following draft text. including the extent to which the text addresses the issues described.

The NRC also solicits suggestions of alternative text that would address these issues.

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Subject Index Tenns for Part 33 Byproduct material. Criminal penalties. Nuclear materials. Radiation protection. Reporting and recordkeeping requirements.

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PART 33 SPECIFIC DOMESTIC LICENSES OF BROAD SCOPE FOR BYPRODUCT MATERIAL 1 . The authority cite for Part 33 continues to read as follows:

AUTHORITY: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954, as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841)

2. A new §33.2 is added to read as follows:

§33.2 Definitions.

Authorized User means an individual specifically named an*d authorized by the Radiation Safety Committee to use licensed material. -

Management means the chief executive officer (or equivalent) or that person's delegate or delegates.

I Radiation Safety Committee means a committee responsible for the development and administration of a licensee's radiation safety program, including responsibility for approval of all proposals for radionuclide use and users.

Radiation Safety Officer means the individual, identified on the license, responsible for the day-to-day operation of the licensee's radiation safety program

3. A new §33.5 is added to read as follows:

§33.5 Records.

Each record required by this part must be legible throughout the retention

_period specified by each Commission regulation. The record may be the original or a reproduced copy or a microform provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period. The record may

---

atso=be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, and specifications must include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.

4. Section 33.11 is revi~ed to read as follows:

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§33.11 Types of specific licenses of broad scope.

(a) A "specific license of broad scope" is a specific license authorizing receipt, acquisition, ownership, possession, use, and transfer of any chemical or physical form of any byproduct material in the quantities specified in the license, for purposes authorized by the Act. A broad scope license authorizes a wide scope of radion*uclides for a diversity of uses and allows licensees to name their own users and areas of use.

-(b) A "master maieriafs- Hcerise" *is a specific .license of broad scope authorized by and issued by the Commission for multisite, to include multiregional, materials (byproduct) licensees. This special type of broad license authorizes a single entity, to issue permits, authorize uses, conduct enforcement, and perform oversight inspections or audits for facilities at multiple sites in multiple regions, including broad scope permits, such that NRC does not review or approve new users and/or locations prior to approval, and does not inspect the permitted facilities under the routine inspection frequency for that type of facility.

5. Section 33.12 is revised to read as follows:

§33.12 Applications for license, amendment, or renewal.

Applications for a new license, an amendment, or a renewal of a specific license of broad scope will be approved if:

(a) The applicant satisfies the general requirements specified in § §30.32 and

30. 33 of this chapter; (b) The applicant has engaged in a reasonable range and number of activities involving the use of byproduct materials under a specific license of limited scope; (c) The applicant's previous performance as a licensee demonstrates an ability to maintain a program in compliance with the Commission's regulations; (d} The licensee designates a Radiation Safety Officer meeting the requirements of §33.21 (b) responsible for implementing the radiation* safety program; (e) The licensee establishes a Radiation Safety Committee meeting the requirements of §33.22{a);

(f) The applicant establishes and submits a description of an adequate management structure and oversight, as well as the mechanisms used to ensure control over licensed activities; 15

(g) The applicant establishes administrative controls and provisions relating to organization and management reviews that are necessary to ensure safe operations; and (h) The applicant establishes, implements, and maintains written policies and procedures, reviewed and approved by the Radiation Safety Committee, adequate for:

( 1) Authorizing the procurement of byproduct material only in accordance with approved permits; (2) Receiving and safely opening packages of byproduct material; (3) Maintaining inventory control and records of transfers of byproduct material; (4) Storing and using byproduct material safely; (5) Requiring notification of the Radiation Safety Officer of emergencies involving byproduct material; (6) Establishing frequencies for performing radiation surveys as required by

§ §20.1501 and 20.1906(b), or by the conditions of the license; (7) Performing calibrations of survey instruments and other equipment used to demonstrate compliance with the regulations, if those calibrations are to be performed in-house; (8) Performing tests for leakage or contamination of sealed sources, if those -

tests are to be performed by the licensee; (9) Disposing of byproduct material in accordance with the requirements of Subpart K, § §20.2001-20.2007.

( 10) Providing or supervising the provision of radiation safety training to personnel prior to their working in or frequenting areas where byproduct material is used or stored;

( 11) Conducting radiation safety evaluations of proposed authorized users of byproduct material, including training and experience and proposed uses;

( 12) Conducting radiation safety evaluations of proposed uses of radioactivity, including an evaluation of the facilities and equipment; 16

( 13) Establi3:--.ing criteria ..ised to determine if a location formerly authorized under the broad scope license may be released for unrestricted use, including the performance of monitoring, acceptable decontamination levels, and documentation of such results; and (14) Reporting and investigating overexposu'res; accidents; spills; losses or thefts; unauthorized receipts, uses, transfers or disposal of byproduct material; and other deviations from radiation safety practices as approved by the Radiation Safety Officer, the Radiation Safety Committee, or the Commission, and implementing corrective actions as necessary.

6. Section 33.17 is revised to read as follows:

§33.17 Requirements of specific licenses of broad scope.

Persons granted a specific license of broad scope shall meet the following requirements:

(a) Unless specifically authorized pursuant to other parts of this chapter, persons licensed under this part shall not:

( 1) Conduct tracer studies in the environment involving direct release of byproduct material; (2) Conduct activities for which a specific license issued by the Commission under Parts 32, 34, 35, 36, or 39 of this cRapter is required; or (3) Add or cause the addition of byproduct material to any food, beverage, cosmetic, drug or other product designed for ingestion or inhalation by, or application to, a human being.

(b) Each specific license of broad scope issued under this part shall be subject to the condition that byproduct material possessed under the license may only be used by, or under the direct supervision of, individuals approved by the licensee's Radiation Safety Committee in accordance with the following:

(1) Byproduct material for non-human use will be used only by, or under the supervision of, individuals whose qualifications have been reviewed and approved in accordance with the licensee's established procedures, and

{2) Byproduct material for medical use will be used only by, or under the supervision of, individuals who meet the applicable training and e~oerience criteria specified in Subpart J, § §35.900-35,981.

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(c) The licensee's management shall notify the Commission, in writing, no later than 30 days after a Radiation Safety Officer permanently discontinues performance of duties as the Radiation Safety Officer under the license, or the name or mailing address of the licensee, as it appears on the license, changes.

(d) The licensee's management shall apply for and must receive a license amendment:

( 1 ) Before naming a permanent Radiation Safety Officer; (2) Before it orders byproduct material in excess of the amount, or radionuclide or form different than authorized on the license; and (3) Before it adds to or changes the address or addresses of use identified in the application or on the license.

7. Sections 33.21 and 33.23 are redesignated as §§33.61 and 33.63 respectively, and new § §33.21, 33.22, and 3*3.23 are added to read as follows:

§33.21 Radiation Safety Officer.

(a) A licensee shall appoint a Radiation Safety Officer responsible for implementing the radiation safety program. The licensee, through the Radiation Safety Officer, shall ensure that radiation safety activities are being performed in accordance with approved procedures and regulatory requirements in the daily operation of the licensee's byproduct material program.

(b) At a minimum, the Radiation Safety Officer shall have an academic degree in physical or biological science or engineering, specific training in radiation health sciences and at least 5 years experience with a broad spectrum of radioactive material related to the types, quantities, and uses of the licensee's program.

(c) The Radiation Safety Officer shall:

( 1) Ensure the implementation of written policies and procedures as specified in §33. 12{g) and (h) above; (2) Assist the Radiation Safety Committee in the performance of its duties, including the provision of necessary reports to the Committee to enable the Committee to conduct the reviews required by §33.17(f) below; 18

(3) Report to management once each year on the byproduct material program; and (4) Keep a copy of all records and reports required by the Commission's regulations, a copy of these regulations, a copy of each licensing request and license and amendments, and the written policy and procedures required by the regulations."

§33.22 Radiation Safety Committee.

Each licensee shall establish a Radiation Safety Committee to oversee the use of byproduct material.

• - (a) The Radiation Safety Committee shall meet the following administrative requirements:

( 1) Membership shall consist of the Radiation Safety Officer; at least one user authorized by the Radiation Safety Committee from each of t_he departments, grnups, or activities that will use byproduct material's permitted by the license; and at least one representative ot management who is neither an authorized user nor a Radiation Safety Officer. For medical broad scope licensees, the Radiation Safety Committee should also include a representative of the nursing service and an authorized user for each type of medical use permitted by the license; (2) The Committee shall meet four times a year at intervals not to exceed 4 months; (3) Minutes shall be prepared for each meeting. Each member of the Committee shall be provided with a copy of the meeting minutes before

, the next meeting, ~nd the Committee shall retain one copy of the meeting minutes for 5 years from the meeting date; and (4) To establish a quorum and to conduct business, at least one-half of the Committee membership must be in attendance, and shall include, at a minimum, the management's representative, an authorized user and the Radiation Safety Officer.

(b) To oversee the use of licensed material, the Radiation Safety Committee shall:

( 1) Ensure the radiation protection programs meet the requirements of

§20.1101; 19

(2) Ensure the implementation of written policies and procedures, as specified in § §33.12(g) and (h), include:

(i) Review of the training and. experience of, and approval or disapproval of, the application of any individual who seeks approval as an authorized user; (ii) Review, on the basis of radiation safety, and approval or disapproval of, each proposed use of byproduct material, including periodic reevaluations of approved uses; (iii) Review and approve radiation safety program changes on the basis of safety; (iv) Review, with the assistance of the Radiation Safety Officer, the records of individual 'Tlonitoring results of all individuals for whom monitoring was required pursuant to §20.1502; (v) Review, with the assistance of the Radiation Safety Officer, all incidents or reports made to the Commission involving byproduct material with respect to cause and subsequent actions taken; and (vi) Establish investigational levels for occupational doses that, when exceeded, require investigations and considerations of action by the Radiation Safety Officer; and (3) Review annually, with the assistance of the Radiation Safety Officer, the - 1 radiation safety program.

§33.23 Statements of Authority and Responsibilities.

(a) A licensee shall provide the Radiation Safety Officer and the Radiation Safety Committee sufficient authority, organizational freedom, and management prerogative, to:

( 1) Identify radiation safety problems; (2) Terminate any activity, involving byproduct material, in which health and safety may be compromised to an unacceptable level, immediately, without consulting licensee management; 20

(3) Approve or disapprove all proposals for byproduct material use prior to procurement of material; (4) Initiate, recommand, or provide corrective actions; and (5) Verify implementation of corrective actions.

(b) A licensee shall establish and state in writing the authorities, duties,

• responsibilities, and radiation safety activities of the Radiation- Safety Officer and the Radiation Safety Committee, and retain the current edition of these statements as a record until the Commission terminates the license.

8. A new §33.25 is added to read as follows:

§33.25 Supervision.

(a) A licensee that permits the receipt, possession, use, or transfer of byproduct material by an individual under the supervision of an authorized user shall:

(1) Instruct the supervised individual in the principles of radiation safety appropriate to that individual's use of byproduct material; (2) Require the supervised individual to follow the instructions of the supervising authorized user, follow the written radiation safety procedures established by the licensee, and comply with the regulations of this chapter and the license conditions with respect to .the use of byproduct material; ,and (b) A licensee that permits the receipt, possess.ion, use, or transfer of by'product material by an individual under the supervision of an authorized user is responsible for the acts and omissions of the supervised individual.

9. A new §33.59 is added to read as follows:

§33.59 Radiation Safety Program Changes.

(a) The holder of a specific license of broad scope for byproduct material may make changes in the facility or procedures as described in the license application, after review and approval by the Radiation Safety Committee, without prior Commission approval, unless the proposed change involves a change in a specific license condition or is less restrictive than the regulations.

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• r, (b) ( 1) The lice, 1see shc:311 11 ,aintain records of changes in the facility and of changes in procedures made pursuant to this section until the license has been renewed or terminated. The record must include the effective date of the change, a copy of the old and new facility or procedure, the reason for the change, a summary of radiation safety matters that were considered before making the change, and the signatures of the Radiation Safety Officer, Radiation Safety Committee chairman, and the management representative. ..

(2) The licensee shall submit a report within 30 days of the effective date of the change, containing a brief description of any changes, including the reason for the change and a summary of the radiation safety matters that were considered for each.

(c) A licensee who desires to make a change that modifies an existing license condition shall submit an application for amendment to its license: i>'ursuant to §30.38. '.'

Dated at Ro~kville, Maryland, this t "3 day of Al~, 1996.

For the Nuclear::. Regulatory Commission, Seer of the Commission.

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