Specific Domestic Licenses of Broad Scope for Byproduct Material

NUCLEAR REGULATORY COMMISSION

10 CFR Part 33

RIN 3150--AF54

Specific Domestic Licenses of Broad Scope for Byproduct Material

AGENCY: Nuclear Regulatory Commission.

ACTION: Advance notice of proposed rulemaking.

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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.

DATES: Comment period expires February 12, 1997. 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, Nuclear

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.

[[Page 58347]]

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

[email protected]

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 specific

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.

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 CFR 33.15.

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:

(1) 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

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 recommended 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-1516, 1 ``Management of Radioactive Material Safety Programs

at Medical Facilities,'' was published in January 1995 for comment, 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.

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\1\ A free single copy of draft NUREG-1516 may be requested by

those considering public comment by writing to the U.S. Nuclear

Regulatory Commission, 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.

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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 type of enforcement

action. However, the majority of these events involved loss of control

of the radioactive material, release of material in excess of the

limits in 10 CFR 20, or contamination outside of the 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 currently developing a new materials licensing process.

To proceed with the implementation of the new process, the NRC staff

recommended certain actions for Commission approval. These included

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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 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 Investigation 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 scope licensees with a clear description of the

duties and responsibilities of the 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 Comments 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 objectives 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 the proposed changes pose any serious

implementation problems. Commenters are invited to make additional

suggestions. In addition to specific questions, draft rule language is

provided, for comment, 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 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. 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 comment 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 comments 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 Sec. 33.15 for issuance of a Type C

specific license of broad scope include specific training and

experience criteria for 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 Sec. 33.15(b)(1) and (2). The NRC is

soliciting comment on whether training and experience criteria

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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 comments as to codification, in the regulations,

of requirements 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 necessary to minimize exposures from

internal pathways. Although the Commission recognizes that there may be

greater uncertainties with the estimation of internal exposure, 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 Regulatory 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 comments on which, if any, aspects of the draft regulatory

guidance for broad scope facilities should be codified in the

regulations.

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?

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

Sec. 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 safety question. The licensee must maintain a written safety

evaluation of the change. Although an unreviewed safety question, as

defined in Sec. 50.2, is not applicable to materials licensees,

Sec. 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 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.

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 Sec. 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 B and 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

its 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 B and

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 other multi-site broad scope

licenses, the NRC inspects a sample of master materials 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 comment process. The NRC is 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 comments on this issue.

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10. Should Requirements for ``Multi-Site Facilities'' Be Codified in

Part 33 or Should This Be Defined Only in 10 CFR Part 30?

A multi-site license is one that includes two or more locations of

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 licensees.

Therefore, although some multi-site licensees may meet the requirements

for a broad scope license, many would continue to be limited specific

licenses. The NRC is soliciting comments on whether a separate category

for multi-site licenses should be included within Part 33 with

commensurate 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 Sec. 20.1201 and the

requirement for a radiation protection program pursuant to

Sec. 20.1101, are examples of performance-based regulations, whereas

the requirements for training for radiographers specified in Sec. 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 comment on costs and benefits, normal

business practices, new trends, and other information that should be

considered in the regulatory analysis. Comments 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 comments 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.

List of Subjects in 10 CFR Part 33

Byproduct material, Criminal penalties, Nuclear materials,

Radiation protection, Reporting and recordkeeping requirements.

PART 33--SPECIFIC DOMESTIC LICENSES OF BROAD SCOPE FOR BYPRODUCT

MATERIAL

1. The authority citation 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 Sec. 33.2 is added to read as follows:

Sec. 33.2 Definitions.

Authorized user means an individual specifically named and

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.

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 Sec. 33.5 is added to read as follows:

Sec. 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 also 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 revised to read as follows:

Sec. 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

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purposes authorized by the Act. A broad scope license authorizes a wide

scope of radionuclides for a diversity of uses and allows licensees to

name their own users and areas of use.

(b) A ``master materials license'' 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:

Sec. 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

Secs. 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 Sec. 33.21(b) responsible for implementing the

radiation safety program;

(e) The licensee establishes a Radiation Safety Committee meeting

the requirements of Sec. 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;

(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 Secs. 20.1501 and 20.1906(b) of this chapter, or by the

conditions of the license;

(7) Performing calibrations of survey instruments and other

equipment used to demonstrate compliance with the regulations of this

chapter, 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, Secs. 20.2001 through 20.2007 of this

chapter.

(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;

(13) Establishing criteria used 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 overexposures; 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:

Sec. 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 chapter 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 experience criteria specified in subpart J, Secs. 35.900 through

35.981 of this chapter.

(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 Secs. 33.61 and

33.63, respectively under the undesignated center heading

``Violations'', and new Secs. 33.21, 33.22, and 33.23 are added to read

as follows:

[[Page 58352]]

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.

(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 Sec. 33.12 (g) and (h);

(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

Sec. 33.17(f);

(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 in 10 CFR Chapter 1, a copy of 10 CFR Chapter

1, a copy of each licensing request and license and amendments, and the

written policy and procedures required by the regulations of this

chapter.

Sec. 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 the departments, groups, or activities that will use byproduct

materials permitted by the license; and at least one representative of

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, and 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 Sec. 20.1101 of this chapter;

(2) Ensure the implementation of written policies and procedures,

as specified in Sec. 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 monitoring results of all individuals for

whom monitoring was required pursuant to Sec. 20.1502 of this Chapter;

(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 radiation safety program.

Sec. 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;

(3) Approve or disapprove all proposals for byproduct material use

prior to procurement of material;

(4) Initiate, recommend, 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 Sec. 33.25 is added to read as follows:

Sec. 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, possession, use, or

transfer of byproduct 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 Sec. 33.59 is added under the undesignated center heading

``Specific Licenses of Broad Scope'' to read as follows:

Sec. 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.

(b)(1) 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. 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

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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 pursuant to Sec. 30.38 of this chapter.

Dated at Rockville, Maryland, this 6th day of November, 1996.

For the Nuclear Regulatory Commission.

John C. Hoyle,

Secretary of the Commission.

[FR Doc. 96-28998 Filed 11-13-96; 8:45 am]

BILLING CODE 7590-01-P