[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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
