[Federal Register Volume 61, Number 221 (Thursday, November 14, 1996)]
[Proposed Rules]
[Pages 58346-58353]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-28998]


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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

[[Page 58348]]

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

[[Page 58349]]

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.

[[Page 58350]]

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

[[Page 58351]]

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

[[Page 58353]]

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