Domestic Licensing of Nuclear Source Material

Donate for the Cryptome collection of files from June 1996 to the present

18 May 2011

[Federal Register Volume 76, Number 95 (Tuesday, May 17, 2011)]
[Proposed Rules]
[Pages 28336-28358]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-11927]

[[Page 28336]]

=======================================================================
-----------------------------------------------------------------------

NUCLEAR REGULATORY COMMISSION

10 CFR Parts 40 and 150

RIN 3150-AI50
[NRC-2009-0079]

Domestic Licensing of Source Material--Amendments/Integrated
Safety Analysis

AGENCY: Nuclear Regulatory Commission.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The U.S. Nuclear Regulatory Commission (NRC or the Commission)
is proposing to amend its regulations by adding additional requirements
for source material licensees who possess significant quantities of
uranium hexafluoride (UF6). The proposed amendments would require such
licensees to conduct integrated safety analyses (ISAs) similar to the
ISAs performed by 10 CFR part 70 licensees; set possession limits for
UF6 for determining licensing authority (NRC or Agreement States); add
defined terms; add an additional evaluation criterion for applicants
who submit an evaluation in lieu of an emergency plan; require the NRC
to perform a backfit analysis under specified circumstances; and make
administrative changes to the structure of the regulations. The
proposed ISA requirements would not apply to facilities that are
currently undergoing decommissioning under the current regulations.
This rulemaking pertains to 10 CFR part 40 licensees and applicants
who possess, or plan to possess, significant quantities of UF6. The
current regulations do not contain ISA requirements for evaluating the
consequences of facility accidents. The proposed amendment would
require applicants and licensees who possess or plan to possess
significant amounts of UF6 to conduct an ISA and submit an ISA summary
to the NRC.
The ISA, which evaluates and categorizes the consequences of
accidents at NRC licensed facilities, would address both the
radiological and chemical hazards from licensed material and hazardous
chemicals produced in the processing of licensed material. Similar
hazards that exist at other fuel cycle facilities are addressed by ISA
requirements elsewhere in the regulations.
The NRC is also proposing new guidance on the implementation of the
additional regulatory requirements for licensees that would be
authorized under this rulemaking.

DATES: Submit comments specific to the proposed rule and draft guidance
document by August 1, 2011. Comments received after this date will be
considered if it is practical to do so, but the NRC is able to assure
consideration only for comments received on or before this date. Submit
comments specific to the information collection aspects of this rule by
June 16, 2011.

ADDRESSES: Please include the applicable Docket ID in the subject line
of your comments. For additional instructions on submitting comments
and accessing documents related to this action, see Section I,
``Submitting Comments and Accessing Information'' in the SUPPLEMENTARY
INFORMATION section of this document. You may submit comments on the
proposed rule (Docket ID NRC-2009-0079) by any one of the following
methods:
Federal Rulemaking Web Site: Go to http://www.regulations.gov and search for documents filed under Docket ID NRC-
2009-0079 for the proposed rule. Address questions about NRC dockets to
Carol Gallagher, telephone: 301-492-3668; e-mail:
Carol.Gallagher@nrc.gov.
Mail comments to: Secretary, U.S. Nuclear Regulatory
Commission, Washington, DC 20555-0001, ATTN: Rulemakings and
Adjudications Staff.
E-mail comments to: Rulemaking.Comments@nrc.gov. If you do
not receive a reply e-mail confirming that we have received your
comments, contact us directly at 301-415-1677.
Hand deliver comments to: 11555 Rockville Pike, Rockville,
MD 20852, between 7:30 a.m. and 4:15 p.m. Federal workdays. (Telephone
301-415-1677).
Fax comments to: Secretary, U.S. Nuclear Regulatory
Commission at 301-415-1101.
You may submit comments on the proposed guidance document (Docket
ID NRC-2011-0080) by any one of the following methods:
Federal Rulemaking Web Site: Go to http://www.regulations.gov and search for documents filed under Docket ID NRC-
2011-0080. Address questions about NRC dockets to Carol Gallagher,
telephone: 301-492-3668; e-mail: Carol.Gallagher@nrc.gov.
Mail comments to: Cindy Bladey, Chief, Rules,
Announcements, and Directives Branch (RADB), Office of Administration,
Mail Stop: TWB-05-B01M, U.S. Nuclear Regulatory Commission, Washington,
DC 20555-0001.
Fax comments to: RADB at 301-492-3446.
You may submit comments on the information collections by the
methods indicated in the Paperwork Reduction Act Statement.

FOR FURTHER INFORMATION CONTACT: Edward M. Lohr, Office of Federal and
State Materials and Environmental Management Programs, U.S. Nuclear
Regulatory Commission, Washington, DC 20555-0001, telephone: 301-415-
0253, e-mail: Edward.Lohr@nrc.gov.

SUPPLEMENTARY INFORMATION:

I. Submitting Comments and Accessing Information
II. Background
III. Discussion
A. What issues is the NRC seeking public comments on?
B. What action is the NRC taking?
C. Whom would this action affect?
D. What steps did NRC take to involve the public in this
proposed rulemaking?
E. What is the basis for the NRC to regulate the hazardous
chemicals produced from licensed materials?
F. Why was 2000 kilograms of UF6 chosen as the threshold for
requiring an ISA and the threshold for NRC jurisdiction?
G. What is Appendix A to 29 CFR 1910.119?
H. Is there an alternative to submitting an emergency plan?
I. What are ERPG's and AEGLs, and what are they used for?
J. When would these ISA requirements become effective?
K. Should the NRC use probabilistic risk analyses methodology at
10 CFR Part 40 licensed facilities?
L. Has NRC prepared a cost-benefit analysis of the proposed
actions?
M. Has NRC evaluated the additional paperwork burden to
licensees?
N. What should I consider as I prepare my comments to NRC?
IV. Discussion of Proposed Amendments by Section
V. Criminal Penalties
VI. Agreement State Compatibility
VII. Plain Language
VIII. Voluntary Consensus Standards
IX. Environmental Impact: Categorical Exclusion
X. Paperwork Reduction Act Statement
XI. Regulatory Analysis
XII. Regulatory Flexibility Certification
XIII. Backfit Analysis

I. Submitting Comments and Accessing Information

Comments submitted in writing or in electronic form will be posted
on the NRC Web site and on the Federal rulemaking Web site, http://www.regulations.gov. Because your comments will not be edited to remove
any identifying or contact information, the NRC cautions you against
including any information in your submission that you do not want to be
publicly disclosed. The NRC requests that any party soliciting or
aggregating comments received from other persons for submission to the
NRC inform those persons that the NRC will not edit their comments to
remove any identifying or contact information, and therefore, they

[[Page 28337]]

should not include any information in their comments that they do not
want publicly disclosed.
You can access publicly available documents related to the proposed
rule and draft guidance document using the following methods:
NRC's Public Document Room (PDR): The public may examine
and have copied, for a fee, publicly available documents at the NRC's
PDR, Room O-1F21, One White Flint North, 11555 Rockville Pike,
Rockville, Maryland 20852.
NRC's Agencywide Documents Access and Management System
(ADAMS): Publicly available documents created or received at the NRC
are available online in the NRC Library at http://www.nrc.gov/reading-rm/adams.html. From this page, the public can gain entry into ADAMS,
which provides text and image files of NRC's public documents. If you
do not have access to ADAMS or if there are problems in accessing the
documents located in ADAMS, contact the NRC's PDR reference staff at 1-
800-397-4209, or 301-415-4737, or by e-mail to PDR.Resource@nrc.gov.
The proposed rule and draft guidance document are available
electronically under ADAMS Accession Numbers ML110890797 and
ML102520022, respectively.
Federal Rulemaking Web Site: Public comments and
supporting materials related to the proposed rule and draft guidance
document can be found at http://www.regulations.gov by searching on the
applicable Docket ID, NRC-2009-0079 (proposed rule) and NRC-2011-0080
(draft guidance document).

II. Background

Health and safety risks at 10 CFR part 40 fuel cycle facilities
authorized to possess significant quantities of UF6 are both
radiological and chemical in nature. These facilities not only handle
radioactive source material but also large volumes of hazardous
chemicals that are involved in processing the nuclear material. For
example, the presence of UF6 in large quantities means that the hazards
of hydrogen fluoride (HF) must be considered. The HF gas (and uranyl
fluoride) is quickly produced from the chemical reaction that occurs
when UF6 is exposed to water, present as humidity in the air, and HF
gas may quickly move offsite. The HF is a highly reactive and corrosive
chemical that presents a substantial inhalation and skin absorption
hazard to both workers and the public.
Such hazards were demonstrated in the 1986 accident involving UF6
and HF at Sequoyah Fuels (a 10 CFR part 40 licensed facility). A
cylinder of UF6 ruptured and resulted in a worker fatality. The cause
of the worker's death was the inhalation of HF gas produced when the
cylinder ruptured. The fact that HF can be produced from UF6 under
certain conditions, and that it has a significant potential for onsite
and offsite consequences, are among the principle factors on which this
proposed rulemaking is based.
The current 10 CFR part 40 does not contain ISA requirements for
evaluating the consequences of facility accidents. Similar hazards,
both radiological and chemical, that exist at fuel cycle facilities
that are regulated under 10 CFR part 70 are addressed by requirements
contained in 10 CFR part 70, subpart H, ``Additional Requirements for
Certain Licensees Authorized To Possess a Critical Mass of Special
Nuclear Material.''
In March 2007, the NRC staff briefed the Commission on health and
safety concerns involving 10 CFR part 40 fuel cycle facilities
authorized to possess significant quantities of UF6. Based on these
concerns, the Commission issued Staff Requirements Memorandum (SRM)-
M070308B, ``Staff Requirements--Briefing on NMSS Programs, Performance,
and Plans'' (March 22, 2007) directing the staff to propose options for
rulemaking that would impose ISA requirements (similar to those
currently found in 10 CFR part 70, subpart H) on current and future 10
CFR part 40 fuel cycle facilities authorized to possess significant
quantities of UF6. The SRM also directed the staff to inform the
Agreement States that the NRC would be the sole regulator for future
major fuel cycle facilities under 10 CFR part 40. The NRC sent a letter
to the Agreement States (ADAMS Accession Number ML071030304) on April
13, 2007, notifying them of the Commission's directive.
In SECY-07-0146 (August 24, 2007), the staff recommended that the
Commission:
(1) Approve keeping the Starmet and Aerojet Ordnance facilities
under Agreement State jurisdiction and, if similar new facilities are
proposed in Agreement States in the future, the NRC would retain
jurisdiction of only those facilities that exceed the threshold
quantity limits discussed in Recommendation 2.
(2) Approve conducting a rulemaking to amend 10 CFR part 40. This
would require new applicants and existing licensees for 10 CFR part 40
fuel cycle facilities with UF6 or uranium tetrafluoride (UF4)
inventories greater than 10,000 kilograms (or alternative threshold
quantity) to meet ISA requirements similar to those in 10 CFR part 70,
subpart H. These requirements would not apply to existing facilities
currently undergoing decommissioning. If new applicants submit license
applications before the completion of the rulemaking, the NRC would
issue orders establishing the 10 CFR part 70, subpart H, performance
requirements as part of the licensing basis for the application review.
The Commission issued SRM for SECY-07-0146, dated October 10, 2007,
approving Recommendations 1 and 2. The Commission stated that if new
license applications are submitted before the completion of the
rulemaking, ``the staff shall impose 10 CFR part 70, subpart H,
performance requirements as part of the licensing basis for the
application review.'' As further directed in the SRM, the NRC held a
public meeting on February 22, 2008, at NRC Headquarters in Rockville,
Maryland, to discuss the scope of the proposed rulemaking and to seek
public input on the proposed threshold quantities for determining when
a facility will be regulated by the NRC or an Agreement State. Industry
stakeholders that would be impacted by the rulemaking and
representatives from four Agreement States attended the meeting either
in person or via teleconference. All participants were encouraged to
send in written comments within 30 days.
The Nuclear Energy Institute (NEI) and Honeywell Specialty
Materials (Honeywell) attended the meeting and both submitted similar
written comments and concerns. While both supported the concept of
threshold UF6 quantities to determine if ISA requirements analogous to
10 CFR part 70, subpart H, should be required for new licensees,
neither supported implementing the proposed ISA requirements at
existing facilities. The commenters expressed the opinion that the
NRC's mission is to protect public health and safety from the effects
of radiological materials, and that this mission does not encompass
chemical hazards. Both noted that the 10 CFR part 70 ISA requirements
focus on preventing criticality events, a concern not relevant to
source material licensees, and assessing and mitigating the
radiological risk of enrichment operations. They felt that the primary
health and safety concerns from licensed operations are chemical in
nature, and since chemical concerns are not the mission of the NRC, the
ISA should be narrowly focused to deal only with radiological concerns.

[[Page 28338]]

Honeywell further noted that it had already voluntarily submitted a
risk-based ISA to support the license renewal of its Metropolis,
Illinois facility, and observed that its plant had only been operating
under the ISA since November 2007. It argued that not enough time has
passed to assess the effectiveness of the current ISA. Therefore,
Honeywell should be given several years to determine whether its
current ISA is adequate before the NRC proceeds with any ISA
rulemaking.
The NRC does not agree with the above NEI and Honeywell comments.
As discussed above, the Sequoyah Fuels accident that killed one of its
employees did not involve a criticality event. The chemical hazard that
produced the fatality resulted from the licensed UF6 material that was
being handled at the facility, and such hazards are within the NRC's
regulatory authority. A more in-depth discussion of the NRC's authority
to regulate these specific chemical hazards can be found in the
following section in Question E. Therefore, generic ISA requirements to
ensure that an adequate level of public health and safety is
maintained, are needed for existing and future 10 CFR part 40
facilities handling significant quantities of UF6.
The NRC staff, in later reviewing all the data and information
available, determined that UF4 did not constitute the same risk as UF6
at 10 CFR part 40 fuel cycle facilities. In a memorandum to the
Commission dated June 23, 2009, the staff informed the Commission of
its findings and intentions not to pursue rulemaking at this time to
require an ISA for licensees possessing UF4 in any quantity.
A draft proposed rule was provided to the Commission in SECY-10-
0128, ``Proposed Rule: Domestic Licensing of Source Material--
Amendments/Integrated Safety Analysis,'' dated October 1, 2010. In
response to SECY-10-0128, the Commission issued an SRM dated November
30, 2010, which directed the staff to publish the draft proposed rule
for public comment subject to Commission comments and changes which
include:
(1) Adding a backfit provision similar to Sec. 70.76, applicable
to any source material licensee authorized to possess 2000 kilograms
(kg) or more of UF6, which becomes effective once such a licensee's ISA
summary has been approved by the NRC;
(2) Seeking public comment with regard to the potential challenges
and impacts on the use of probabilistic risk analyses methodology at 10
CFR part 40 facilities;
(3) Publishing concurrently with the proposed rule draft regulatory
guidance and a standard review plan related to the proposed rule;
(4) Issuing guidance regarding the completion of ISAs to account
for differences in the processes or hazards for 10 CFR part 40
facilities, as compared to 10 CFR part 70 facilities; and
(5) Providing (from the effective date of the rule) 6 months to
develop an ISA plan; 18 months to produce an ISA; and 3 years to
correct all performance deficiencies.
Additionally, the SRM directed the staff to determine whether the
1988 Memorandum of Understanding (MOU) between the NRC and the
Occupational Safety and Health Administration (OSHA) needs to be
modified. If no need to modify the MOU was found, the SRM directed the
staff to provide a clear explanation in this proposed rule and in
guidance of how MOU Criterion 3 should be evaluated by a licensee in
completing its ISA. The MOU Criterion 3 references plant conditions
affecting ``the safety of radioactive materials and [which] thus
presents an increased radiation risk to workers.'' As discussed further
in Question E in Section III (Discussion), the staff found there was no
need to modify the MOU, and guidance on how MOU Criterion 3 should be
evaluated in completing ISAs has been developed. Comments on the draft
guidance for this proposed rule may be submitted to the NRC by the
methods listed in the ADDRESSES section of this document.

III. Discussion

A. What issues is the NRC seeking public comments on?

In addition to seeking comments in general on the proposed rule,
the NRC is seeking specific public comments on the proposed provision
to require an additional evaluation criterion in Sec. 40.84(b) for
chemical hazards. This criterion is not currently required for any fuel
cycle facility. Specific discussion on this issue is located in
Question H of this section and in Section IV (Discussion of Proposed
Amendments by Section).
Additionally, the NRC is seeking public comments on the potential
challenges and impacts of conducting probabilistic risk analyses (PRAs)
rather than ISAs for 10 CFR part 40 fuel cycle facilities. This issue
is discussed in Question K of this section.
Comments on these issues may be submitted as described in the
ADDRESSES section of this document.

B. What action is the NRC taking?

The NRC is proposing to amend 10 CFR part 40 to require applicants
or licensees that are, or plan to be, authorized to possess 2000 kg or
more of UF6 to conduct an ISA and submit an ISA summary. The new ISA
requirements would be similar to requirements found in 10 CFR part 70
subpart H, which apply to fuel fabrication and enrichment facilities.
In the rulemaking, the NRC would assert jurisdiction over all
applicants and licensees that may possess 2000 kg or more of UF6.
The rulemaking would add an additional evaluation criterion for
applicants or licensees that submit an evaluation in lieu of the
emergency plan required by Sec. 40.31(j). The evaluation would have to
demonstrate that an acute chemical exposure from licensed material or
hazardous chemicals produced from licensed material due to a release
would result in neither irreversible nor mild transient health effects
to a member of the public offsite. If such an evaluation is not
submitted, an emergency plan must be submitted in accordance with Sec.
40.31(j)(3).
The format of the requirements contained in 10 CFR part 40 would be
administratively restructured to create subparts. Included in the
restructuring would be the addition of a new subpart titled,
``Additional Requirements for Certain Licensees Authorized to Possess
2000 kilograms (4400 lb) or More of Uranium Hexafluoride.'' The
rulemaking would also add definitions to Sec. 40.4 that pertain to the
proposed ISA requirements.
The rulemaking would add a backfit provision applicable to
licensees authorized to possess 2000 kg or more of UF6. This provision
would be similar to existing Sec. 70.76.

C. Whom would this action affect?

The proposed amendment would affect current licensees and future
applicants that possess or plan to possess 2000 kg or more of UF6.
Agreement States and NRC licensees that are currently in the process of
decommissioning would be exempt from the new requirements.
All future facilities authorized to possess 2000 kg or more of UF6
would be licensed by the NRC. On April 13, 2007, a letter was sent to
all the Agreement States (FSME-07-036) informing them that the NRC
``will regulate future major fuel cycle facilities licensed under 10
CFR part 40, e.g., uranium conversion and deconversion facilities.''

[[Page 28339]]

D. What steps did NRC take to involve the public in this proposed
rulemaking?

The NRC held a public meeting on February 22, 2008, at NRC
Headquarters in Rockville, Maryland, to discuss the scope of the
proposed rulemaking and to seek public input on the proposed threshold
quantities for determining when a facility will be regulated by the NRC
or an Agreement State. The NRC announced the meeting on the NRC Web
site as well as in a press release sent out by the Office of Public
Affairs. The industry stakeholders that would be impacted by the
rulemaking attended the meeting. The meeting followed a workshop
format, and representatives from Honeywell and NEI gave presentations.
All participants were encouraged to send written comments within 30
days.

E. What is the basis for the NRC to regulate the hazardous chemicals
produced from licensed materials?

Health and safety risks at uranium 10 CFR part 40 fuel cycle
facilities authorized to possess significant quantities of UF6 are both
radiological and chemical in nature. These facilities not only handle
radioactive source material, but also large volumes of hazardous
chemicals that are produced from the processing of the nuclear
material. As previously explained, chemicals such as HF can be
incidentally produced in processes that involve using UF6, and HF. Due
to its reactive and corrosive qualities, HF has a significant potential
to generate harmful onsite consequences to workers, and harmful offsite
consequences to the public.
The basis for the NRC's oversight of hazardous chemicals produced
from licensed materials is derived from the Atomic Energy Act (AEA).
Section 161 of the AEA gives the NRC broad authority to establish
regulatory requirements necessary to protect the public health and
safety, and Chapter 7 of the AEA details the specific statutory bases
for NRC licensing and regulating the use of source material, such as
UF6. The 1988 MOU between the NRC and OSHA (53 FR 43950) further
discusses the radiological and chemical hazards to workers handling
radiological materials licensed by NRC. It defines the general areas of
responsibilities for the NRC and OSHA at facilities that have both
radiological and chemical hazards.
The NRC-OSHA MOU states that ``there are four kinds of hazards that
may be associated with NRC-licensed nuclear facilities.'' It identifies
them as:
1. Radiation risk produced by radioactive materials;
2. Chemical risk produced by radioactive materials;
3. Plant conditions which affect the safety of radioactive
materials and thus present an increased radiation risk to workers;
4. Plant conditions which result in an occupational risk, but do
not affect the safety of licensed radioactive materials.
The NRC-OSHA MOU states that the ``NRC responsibilities cover the
first three nuclear facility hazards'' and the ``NRC does not have
statutory authority for the fourth hazard.''
The first three hazards and their attendant health and safety
risks, involving the possession and use of licensed radioactive
materials, are clearly regulated by the NRC (or by Agreement States to
which AEA authority has been delegated) and are within the NRC's proper
jurisdiction. Large quantities of hazardous chemicals, such as HF, can
be generated during accidents at NRC-licensed facilities. Chemical
hazards can impact radiological safety by incapacitating or causing
death of a radiation worker who is performing a critical function in
the processing of radioactive material.
As previously discussed, the SRM on SECY-10-0128 directed the staff
to evaluate whether the MOU needed to be modified. Feedback from
cognizant NRC Offices and OSHA indicated the MOU adequately delineates
the agencies' respective responsibilities at nuclear facilities. In
accordance with the SRM, a clear explanation and example of how to
evaluate the MOU's Criterion 3 is in the discussion of the proposed
Sec. 40.81(a) in Section IV (Discussion of Proposed Amendments by
Section) of this document. Guidance on the MOU's Criterion 3 has also
been added to the draft guidance, NUREG-1962, developed to support the
rulemaking. The draft guidance explains how MOU Criterion 3 should be
evaluated by a licensee in completing its ISA.

F. Why was 2000 kilograms of UF6 chosen as the threshold for requiring
an isa and the threshold for NRC jurisdiction?

The staff, in SECY-07-0146, recommended that 10,000 kg of UF6 be
the threshold quantity for requiring 10 CFR part 40 fuel cycle
licensees to perform an ISA and for NRC licensing jurisdiction. The NRC
staff subsequently looked at threshold limits and determined that
quantities of UF6 greater than 2000 kg represented a significant
quantity. This reduction from 10,000 to 2000 kg was based in part on
the chemical hazard associated with accident scenarios involving UF6.
Specifically, in an accident scenario involving 2000 kg of UF6,
approximately 453 kg (1000 lb) of HF vapor could be produced. OSHA, in
Appendix A of Title 29 of the CFR (29 CFR) Section 1910.119, identifies
threshold quantities of hazardous chemicals that ``present a potential
for a catastrophic event.'' The HF is listed in this appendix with a
threshold quantity of 1000 lb. In Appendix A to 29 CFR 1910.119, OSHA
lists toxic and reactive highly hazardous chemicals which present a
potential for a catastrophic event at or above specified threshold
quantities. The regulations also contain requirements for preventing or
minimizing the consequences of catastrophic releases of toxic,
reactive, flammable, or explosive chemicals that may result in toxic,
fire, or explosion hazards.
The NRC believes that chemical quantities exceeding the quantities
listed in Appendix A to 29 CFR 1910.119 at 10 CFR part 40 fuel cycle
facilities can, and do, affect the safety of radioactive materials and
thus present an increased radiation risk to workers.
Although the NRC staff originally recommended that licensees in
possession of large quantities of UF4 also be required to submit an
ISA, it was determined that UF4 did not pose the same risk as UF6. The
UF4 is far less reactive than UF6, requiring days to months to react
with moisture in the air. Based on a search of published literature,
the staff does not believe there is sufficient information available to
establish a threshold of UF4 for requiring an ISA or for the NRC to
establish exclusive jurisdiction.

G. What is Appendix A to 29 CFR 1910.119?

Appendix A to 29 CFR 1910.119 is part of an OSHA regulation that
contains a listing of toxic and reactive highly hazardous chemicals
which present a potential for a catastrophic event at or above the
threshold quantity. The regulations at 29 CFR 1910.119 has requirements
for preventing or minimizing the consequences of catastrophic releases
of toxic, reactive, flammable, or explosive chemicals that may result
in toxic, fire, or explosion hazards. However, Sec. 1910.119 does not
provide structured risk-informed requirements for evaluating the
consequences of facility accidents as an ISA does.
Under the OSHA regulation, facilities that possess hazardous
chemicals in quantities greater than listed in Appendix A to 29 CFR
1910.119 must perform a process hazard analysis. This analysis is
similar but less comprehensive than the requirements in

[[Page 28340]]

the proposed ISA. Additionally, Sec. 1910.119 only addresses chemical
hazards. An ISA would address both the radiological and chemical
hazards from licensed material and hazardous chemicals produced in the
processing of licensed material.

H. Is there an alternative to submitting an emergency plan?

Yes. The current regulations in Sec. 40.31(j) require any licensee
or applicant who plans to possess 1000 kg or more of UF6 (or more than
50 kg in a single container) to submit an emergency plan or, per Sec.
40.31(j)(1)(i), an evaluation showing that the maximum intake of
uranium by a member of the public due to a release would not exceed 2
milligrams. The proposed rule would add an additional criterion, in
addition to Sec. 40.31(j)(1)(i), for licensees or applicants who
possess, or plan to possess, 2000 kg or more of UF6, and who opt to
submit an evaluation in lieu of submitting an emergency plan. This
additional criterion would require a demonstration that an acute
chemical exposure from licensed material or hazardous chemicals
produced from licensed material due to a release, would result in
neither irreversible nor mild transient health effects to a member of
the public offsite. An acute exposure guideline level (AEGL) or
emergency response planning guidelines (ERPG) standard may be used in
making this demonstration. Where no AEGL or ERPG is available, the
applicant/licensee may develop or adopt a criterion that is comparable
in severity to those that have been established for other chemicals.

I. What are ERPG's and AEGLs, and what are they used for?

Chemical consequence criteria corresponding to anticipated adverse
health effects to humans from acute exposures (i.e., a single exposure
or multiple exposures occurring within a short time--24 hours or less)
have been developed, or are under development, by a number of
organizations. A set of chemical consequence criteria, known as ERPGs,
has been developed by the American Industrial Hygiene Association to
provide estimates of concentration ranges where defined adverse health
effects might be observed because of short exposures to hazardous
chemicals. The ERPG criteria are widely used by those involved in
assessing or responding to the release of hazardous chemicals.
Another organization, the National Advisory Committee for Acute
Guideline Levels for Hazardous Substances, is developing AEGLs. The
committee, which works under the auspices of the Environmental
Protection Agency (EPA) and the National Academy of Sciences, has
identified a priority list of approximately 471 chemicals. Consequence
criteria for approximately 200 extremely hazardous substances have been
developed, including one for HF. As previously discussed, HF is a
significant hazard associated with UF6.

J. When would these ISA requirements become effective?

Current licensees would have to submit for NRC approval, within 6
months after the rule becomes effective, a plan that describes the
integrated safety analysis approach that will be used, the processes
that will be analyzed, and the schedule for completing the analysis of
each process. Unless an alternate schedule is approved, the licensee
would submit for NRC approval an integrated safety analysis summary
within 18 months after the rule becomes effective.
Additionally, within 3 years after the rule becomes effective
(unless an alternate schedule is approved), current licensees would
have to correct all unacceptable performance deficiencies identified in
the ISA. Pending the correction of unacceptable performance
deficiencies, the licensee would have to implement appropriate
compensatory measures to ensure adequate protection.

K. Should the NRC use probabilistic risk analyses methodology at 10 CFR
Part 40 licensed facilities?

A PRA is a systematic methodology to evaluate risks associated with
complex technologies, often applied to light water power reactors
licensed under 10 CFR part 50. A PRA usually answers three basic
questions: What can go wrong, how severe are the consequences, and what
are their probabilities or frequencies? The Commission has published a
policy statement on the use of PRA entitled ``Use of Probabilistic Risk
Assessment Methods In Nuclear Regulatory Activities,'' dated August 10,
1995.
The proposed rule does not contain a provision for using a PRA.
However, the Commission has directed the staff to seek public comments
on the potential challenges and impacts regarding the use of PRA
methodology at facilities licensed under 10 CFR part 40. Additional
information on PRA is available in documents related to the review
conducted by the Advisory Committee on Reactor Safeguards including:
1. December 15, 2010, staff document entitled ``A Comparison of
Integrated Safety Analysis and Probabilistic Risk Assessment''
(accession number ML103330478); and
2. February 17, 2011, ACRS response letter entitled ``Comparison of
Integrated Safety Analysis (ISA) and Probabilistic Risk Assessment
(PRA) for Fuel Cycle Facilities'' (accession number ML110460328).
Comments on this issue may be submitted as described in the
ADDRESSES section of this document.

L. Has NRC prepared a cost-benefit analysis of the proposed actions?

The NRC staff has prepared a regulatory analysis for this
rulemaking. This analysis shows an estimated annual cost of $119,000
for each NRC licensee and $17,000 for the NRC from this proposed rule.
The cost to Agreement States to implement this rule was estimated to be
minimal; therefore, the cost to Agreement States was not quantified in
the regulatory analysis supporting the rule.

M. Has NRC evaluated the paperwork burden to licensees?

This proposed rule contains new or amended information collection
requirements that are subject to the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq). The NRC staff has estimated the impact that
this proposed rule will have on reporting and recordkeeping
requirements for NRC licenses. There are no reporting or recordkeeping
requirements for the Agreement State licensees. The NRC is seeking
public comment on these proposed requirements. More information on this
subject is in Section X, Paperwork Reduction Act Statement, of this
document.

N. What should I consider as I prepare my comments to NRC?

Tips for preparing your comments. When submitting your comments,
remember to:
i. Identify the rulemaking (RIN 3150-AI50), Docket ID NRC-2009-
0079.
ii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iii. Describe any assumptions and provide any technical information
and/or data that you used.
iv. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
v. Provide specific examples to illustrate your concerns, and
suggest alternatives.

[[Page 28341]]

vi. Explain your views as clearly as possible.
vii. Make sure to submit your comments by the comment period
deadline identified.
viii. See Section VII for the request for comments on the use of
plain language, Section X for the request for comments on the
information collection, and Section XI for the request for comments on
the draft regulatory analysis.

IV. Discussion of Proposed Amendments by Section

The format of the requirements contained in 10 CFR part 40 would be
administratively restructured to conform to the structures of other
parts in 10 CFR. Currently 10 CFR part 40 has undesignated subject
headings preceding related sections. This proposed rule would replace
the undesignated subject headings with specific lettered and titled
subparts. In addition to this administrative restructuring, a new
subpart H would be added to 10 CFR part 40, titled ``Additional
Requirements for Certain Licensees Authorized to Possess 2000 Kilograms
(4400 lb) or More of Uranium Hexafluoride.'' The proposed new 10 CFR
part 40 subpart H would be similar to the existing subpart H to 10 CFR
part 70.

Section 40.3a Denial of Licensing by Agreement States

This new section would specify that Agreement States lack
regulatory authority over persons who possess or plan to possess 2000
kg or more of UF6. This section would not apply to facilities in
Agreement States that are undergoing decommissioning as of the
effective date of this regulation. The NRC would be the sole licensing
authority for all classes of licensees who possess or plan to possess
2000 kg or more of UF6 (including generally and specifically licensed
activities), and the NRC would thus hold licensing authority for all
radiological activities of such licensees. This proposed requirement is
consistent with the Commission's direction in SRM-M070308B, dated March
22, 2007, and the letter that the NRC sent to all the Agreement States
(FSME-07-036), dated April 13, 2007, informing them that the NRC ``will
regulate future major fuel cycle facilities licensed under 10 CFR part
40, e.g., uranium conversion and deconversion facilities.'' The
proposed requirement is similar to the existing Sec. 72.8 requirement.

Section 40.4 Definitions

Definitions of the following 11 terms used in the new subpart H
would be added to Sec. 40.4: ``Acute,'' ``Available and reliable to
perform their function when needed, ``Configuration management,''
``Defense-in-depth practices,'' ``Hazardous chemicals produced from
licensed materials,'' ``Integrated safety analysis,'' ``Integrated
safety analysis summary,'' ``Items relied on for safety,'' ``Management
measures,'' ``Unacceptable performance deficiencies,'' and ``Worker.''
Except as specified below, these terms are defined the same as
those used in 10 CFR part 70, subpart H. Language referencing
criticality events was removed from the definitions for ``integrated
safety analysis'' and ``unacceptable performance deficiencies'' because
10 CFR part 40 licensees do not possess special nuclear material in
concentrations where criticality events are possible. The proposed
``defense-in-depth'' definition originates from the footnote in Sec.
70.64 that describes what defense-in-depth means.

Section 40.8 Information Collection Requirements: OMB Approval

Paragraph (b) of this section would be amended to add the
applicable sections in the new subpart H and to reflect the
administrative renumbering of 10 CFR part 40.

Section 40.26 General License for Possession And Storage of Byproduct
Material as Defined in This Part

Paragraph (c)(1) of this section would be amended to add the
applicable sections in the new subpart H and to reflect the
administrative renumbering of 10 CFR part 40.

Section 40.80 Applicability

This new section would list the types of NRC licensees or
applicants who would be subject to the new subpart H. The new
requirements would apply to all applicants or licensees that are or
plan to be authorized to possess 2000 kg or more of UF6. In general,
the new subpart is intended to ensure that significant accidents, that
are possible at 10 CFR part 40 fuel cycle facilities authorized to
possess 2000 kg or more of UF6 have been analyzed in advance and that
appropriate controls or measures are established to ensure adequate
protection of workers, the public, and the environment.
The requirements and provisions in subpart H are in addition to,
and not a substitute for, other applicable requirements, including
those of the EPA and the U.S. Department of Labor, OSHA. The proposed
NRC requirements would only apply to NRC's areas of responsibility
(radiological safety and chemical safety directly related to licensed
radioactive material). In this regard, the proposed requirements for
hazards and accident analyses are intended to complement but not
supersede any parallel OSHA and EPA regulations.
The new requirements in subpart H would not apply to licensees who,
as of the effective date of the final rule, are undergoing
decommissioning under the provisions of Sec. 40.42. The NRC notes that
existing Sec. 40.42(g)(4)(iii) states that a proposed decommissioning
plan (DP) must include ``a description of methods used to ensure
protection of workers and the environment against radiation hazards
during decommissioning.'' Because the DP is submitted for NRC approval
before initiation of procedures and activities necessary to carry out
decommissioning of the site or separate building or outdoor area, the
DP will continue to be the vehicle for regulatory approval of the
licensee's practices for protection of health and safety during
decommissioning. The ISA should provide valuable information with
respect to developing the DP and the use of the ISA in this manner is
encouraged.

Section 40.81 Performance Requirements

This new section would explicitly address potential radiological
and chemical exposures to workers or members of the public and
environmental releases as a result of accidents. The requirements in 10
CFR part 20 continue to be NRC's general standard for protection of
workers and the public from licensed activities during normal
operations and accidents. Although it is the NRC's intent that the
regulations in 10 CFR part 20 also be observed to the extent
practicable during an emergency, it is not the NRC's intent that the 10
CFR part 20 requirements apply as the design standard for all possible
facility accidents, irrespective of the likelihood of those accidents.
Because accidents are unanticipated events that usually occur over a
relatively short period of time, the proposed changes to 10 CFR part 40
seek to assure adequate protection of workers, members of the public,
and the environment by limiting the risk (combined likelihood and
consequence) of accidents.
Two risk-informed performance requirements are being proposed, both
of which are set out in Sec. 40.81: (1) Paragraph (b) states that
high-consequence events must meet a likelihood standard of highly
unlikely; and (2) paragraph (c) states that intermediate-consequence
events must

[[Page 28342]]

meet a likelihood standard of unlikely. The term ``performance
requirements'' thus considers together consequences and likelihood. For
regulatory purposes, each performance requirement is considered an
equivalent level of risk. For example, the acceptable likelihood of
intermediate-consequence events is allowed to be greater than the
acceptable likelihood for high-consequence events.
Section 40.81(a). A risk-informed approach must consider not only
the consequences of potential accidents, but also their likelihood of
occurrence. As mentioned above, the performance requirements rely on
the terms ``unlikely'' and ``highly unlikely'' to focus on the risk of
accidents. However, the NRC has decided not to include in the proposed
rule quantitative definitions of the terms ``unlikely'' and ``highly
unlikely,'' because a single definition for each term that would apply
to all the facilities regulated by 10 CFR part 40 may not be
appropriate. Depending on the type of facility and its complexity, the
number of potential accidents and their consequences could differ
markedly. Therefore, to ensure that the overall facility risk from
accidents is acceptable for different types of facilities, the rule
requires applicants to develop, for NRC approval, the meaning of
``unlikely'' and ``highly unlikely'' specific to their processes and
facility (see discussion of Sec. 40.84 in this document). Guidance
documents are being developed to provide examples of acceptable
approaches for the meaning of ``unlikely'' and ``highly unlikely'' that
can be applied to existing 10 CFR part 40 fuel cycle facilities
authorized to possess 2000 kg or more of UF6.
The general approach for complying with the performance
requirements is that, at the time of licensing, each hazard (e.g.,
fire, chemical, electrical, industrial) that can potentially affect
either radiological health and safety, or chemical safety associated
with hazardous chemicals produced from licensed material, is identified
and evaluated by the licensee or applicant in an ISA. The impact of
accidents, both internal and external, associated with these hazards is
compared with the two performance requirements. Any (and all)
structures, systems, components, or human actions, for which credit is
taken in the ISA for mitigating (reducing the consequence of) or
preventing (reducing the likelihood of) the accident such that the two
performance requirements are satisfied, must be identified as an ``item
relied on for safety'' (IROFS). Under this approach, the licensee or
applicant has a great deal of flexibility in selecting and identifying
the actual ``items.'' For example, IROFS can be defined at the systems-
level, component-level, or sub-component level. ``Management measures''
(see discussion of Sec. 40.82(d) in this document) are applied to
IROFS in a graded fashion to ensure that the item will perform its
safety function when needed. The combination of the set of ``items
relied on for safety'' and the ``management measures'' applied to each
item will determine the extent of the licensee's programmatic and
design requirements, consistent with the facility risk, and will ensure
that at any given time, the facility risk is maintained safe and
protected from accidents.
The proposed performance requirements also address certain
hazardous chemicals produced from licensed nuclear material. The
question of the extent of NRC's authority to regulate chemical hazards
at its fuel cycle facilities was raised after the Sequoyah Fuels
accident discussed above, which resulted in a worker fatality. The
cause of the worker's death was the inhalation of HF gas, which was
produced from the chemical reaction of UF6 and water (present as
humidity in air). Partly as a result of the coordinated Federal
response and resulting Congressional investigation into that accident,
the NRC and the OSHA entered into an MOU in 1988 that clarified the
agencies' interpretations of their respective responsibilities for the
regulation of chemical hazards at nuclear facilities. The MOU
identified the following four areas of responsibility. Generally, the
NRC covers the first three areas, whereas OSHA covers the fourth area:
(1) Radiation risk produced by radioactive materials;
(2) Chemical risk produced by radioactive materials;
(3) Plant conditions that affect the safety of radioactive
materials; and
(4) Plant conditions that result in an occupational risk, but do
not affect the safety of licensed radioactive materials.
One goal of the proposed performance requirements in Sec. 40.81 is
to be consistent with the NRC-OSHA MOU. Therefore, the performance
requirements in Sec. 40.81 include explicit standards for the MOU's
first two areas of responsibility. In addition, the third MOU area of
responsibility is specifically evaluated by licensees under the ISA
requirements of Sec. 40.82(c)(1)(iii). As an example of the third MOU
area, if the failure of a chemical system adjacent to a nuclear system
could affect the safety of the nuclear system such that the radiation
dose (and associated likelihood of that accident) exceeded a
performance requirement, the chemical system failure would be within
the scope of the ISA and the means to prevent the chemical system
failure from impacting the nuclear system would be within the NRC's
regulatory purview.
Within each performance requirement, the NRC recognizes that the
proposed radiological standards are more restrictive, in terms of acute
health effects to workers or the public, than the chemical standards
for a given consequence (high or intermediate). This is consistent with
the NRC's current regulatory practice. The choice of each criterion is
discussed in a paragraph-by-paragraph discussion of Sec. 40.81(b)
through (e) in this document.
The use of any of the performance requirements is not intended to
imply that the specified worker or public radiation dose or chemical
exposure constitutes an acceptable criterion for a maximum allowed dose
to a worker or the public. Rather, these values have been proposed in
this section as a reference value, to be used by licensees in the ISA
(a forward-looking analysis) to establish controls (i.e., items relied
on for safety (IROFS) and associated management measures) necessary to
protect workers from potential accidents with low or exceedingly low
probabilities of occurrence that are not expected to occur during the
operating life of the facility.
Section 40.81(b). This provision addresses performance requirements
for ``high-consequence events.'' Such events include accidental
radiological or chemical exposure of a worker or an individual located
outside of the controlled area, and would involve exposure to high
levels of radiation or hazardous chemicals produced from licensed
materials. A high-consequence radiological accident, if it occurred,
would produce radiation doses to a worker or an individual located
outside of the controlled area at levels causing clinically observable
biological damage. A high-consequence chemical accident would involve
concentrations of hazardous chemicals produced from licensed material,
and would be severe enough to cause death or life-threatening injury.
The goal is to ensure an acceptable level of risk by limiting the
combination of the likelihood of occurrence and the identified
consequences. Thus, high-consequence events must be sufficiently
mitigated to a lower consequence or prevented such that the event is
highly unlikely to occur. The application of ``items relied on for
safety'' provides this prevention or mitigation function.

[[Page 28343]]

Section 40.81(b)(1). An acute exposure of a worker to a radiation
dose of 1 Sv (100 rem) or greater total effective dose equivalent
(TEDE) is considered to be a high-consequence event. According to the
National Council on Radiation Protection and Measurements (NCRP, 1971),
life-saving actions--including the ``search for and removal of injured
persons, or entry to prevent conditions that would probably injure
numbers of people''--should be undertaken only when the ``planned dose
to the whole body shall not exceed 100 rems.'' This is consistent with
a later NCRP position (NCRP, 1987) on emergency occupational exposures,
that states ``when the exposure may approach or exceed 1 Gy (100 rad)
of low-LET [linear energy transfer] radiation (or an equivalent high-
LET exposure) to a large portion of the body, in a short time, the
worker needs to understand not only the potential for acute effects but
he or she should also have an appreciation of the substantial increase
in his or her lifetime risk of cancer.''
Section 40.81(b)(2). The exposure of an individual located outside
of the controlled area to a radiation dose of 0.25 Sv (25 rem) or
greater TEDE is considered a high-consequence event. This is generally
consistent with the criterion established in 10 CFR 100.11,
``Determination of exclusion area, low population zone, and population
center distance,'' and 10 CFR 50.34, ``Contents of applications;
technical information,'' in which a whole-body dose of 0.25 Sv (25 rem)
is used to determine the dimensions of the exclusion area and low-
population zone required for siting nuclear power reactors.
Section 40.81(b)(3). The intake of 30 mg of soluble uranium by an
individual located outside of the controlled area is considered a high-
consequence event. This value is consistent with the performance
requirements in Sec. 70.61 which applies to fuel cycle facilities.
Additionally, the use of this value is consistent with the selection of
30 mg of uranium as a criterion during the 10 CFR part 76 rulemaking
(59 FR 48944; September 23, 1994).
Section 40.81(b)(4). An acute chemical exposure to hazardous
chemicals produced from licensed material at concentrations that either
(1) could cause death or life-threatening injuries to a worker; or (2)
could cause irreversible health effects to an individual located
outside of the controlled area, is considered a high-consequence event.
Chemical consequence criteria corresponding to anticipated adverse
health effects to humans from acute exposures (i.e., a single exposure
or multiple exposures occurring within a short time-24 hours or less)
have been developed, or are under development, as discussed in Section
II, question H above.
The qualitative language in Sec. 40.81(b)(4) allows the applicant/
licensee to propose and adopt an appropriate standard, which may be an
AEGL or ERPG standard. Where no AEGL or ERPG is available, the
applicant/licensee may develop or adopt a criterion that is comparable
in severity to those that have been established for other chemicals.
This approach is currently being used in 10 CFR part 70 for fuel cycle
facilities.
Section 40.81(c). This provision addresses performance requirements
for ``intermediate-consequence events,'' which would be of a lower
magnitude than high consequence events, and thus not involve risk of
death or life-threatening injury. Intermediate-consequence events
include accidental radiological or chemical exposure of a worker or an
individual located outside of the controlled area and would involve
exposure to levels of radiation or hazardous chemicals produced from
licensed materials that generally correspond to permanent injury to a
worker or transient injury to a non-worker. An intermediate-consequence
event is also specified as including significant releases of
radioactive material to the environment.
The goal is to ensure an acceptable level of risk by limiting the
combination of the likelihood of occurrence and the identified
consequences. Thus, ``intermediate consequence events'' must be
sufficiently mitigated to a lower consequence or prevented such that
the event is unlikely to occur. The application of ``items relied on
for safety'' provides this prevention or mitigation function.
Section 40.81(c)(1). A worker radiation dose between 0.25 Sv (25
rem) and 1 Sv (100 rem) TEDE is considered an intermediate-consequence
event. This value was chosen because of the use of 0.25 Sv (25 rem) as
a criterion in existing NRC regulations. For example, in 10 CFR
20.2202, ``Notification of incidents,'' immediate notification is
required of a licensee if an individual receives ``* * * a total
effective dose equivalent of 0.25 Sv (25 rem) or more.'' Also, in 10
CFR 20.1206, ``Planned special exposures,'' a licensee may authorize an
adult worker to receive a dose in excess of normal occupational
exposure limits if a dose of this magnitude does not exceed 5 times the
annual dose limits [i.e., 0.25 Sv (25 rem)] during an individual's
lifetime. In addition, EPA's Protective Action Guides (U.S.
Environmental Protection Agency, 1992) and NRC's regulatory guidance
(Regulatory Guide 8.29, ``Instruction Concerning Risks from
Occupational Radiation Exposure'' 1996) identify 0.25 Sv (25 rem) as
the whole-body dose limit to workers for life-saving actions and
protection of large populations. The NCRP has also stated that a TEDE
of 0.25 Sv (25 rem) corresponds to the once-in-a-lifetime accidental or
emergency dose for workers.
Section 40.81(c)(2). A dose to any individual located outside of
the controlled area between 0.05 Sv (5 rem) and 0.25 Sv (25 rem) is
considered an intermediate-consequence event. The NRC has used a 0.05-
Sv (5-rem) exposure criterion in a number of its existing regulations.
For example, 10 CFR 72.106, ``Controlled area of an ISFSI or MRS,''
states that ``Any individual located on or beyond the nearest boundary
of the controlled area shall not receive a dose greater than 5 rem to
the whole body or any organ from any design basis accident.'' In
addition, in the regulation of the above-ground portion of a proposed
geologic repository, 10 CFR 60.136, ``Preclosure controlled areas,''
states that ``for [accidents], no individual located on or beyond any
point on the boundary of the preclosure controlled area will receive a
total effective dose equivalent of 5 rem.'' A TEDE of 0.05 Sv (5 rem)
is also the upper limit of EPA's Protective Action Guides of between
0.01 to 0.05 Sv (1 to 5 rem) for emergency evacuation of members of the
public in the event of an accidental release that could result in
inhalation, ingestion, or absorption of radioactive materials.
Section 40.81(c)(3). The release of radioactive material to the
environment outside the restricted area in concentrations that, if
averaged over a period of 24 hours, exceed 5000 times the values
specified in Table 2 of Appendix B to 10 CFR part 20, is considered an
intermediate-consequence event. In contrast to the other consequences
criteria that directly protect workers and members of the public, the
intent of this criterion is to minimize the environmental impacts. The
value established for this consequence criterion is identical to the
NRC Abnormal Occurrence (AO) criterion that addresses the discharge or
dispersal of radioactive material from its intended place of
confinement (Section 208 of the Energy Reorganization Act of 1974, as
amended, requires that AOs be reported to Congress annually). In
particular, the AO reporting Criterion 1.B requires the reporting of an
event

[[Page 28344]]

that involves ``* * * the release of radioactive material to an
unrestricted area in concentrations which, if averaged over a period of
24 hours, exceed 5000 times the values specified in Table 2 of Appendix
B to 10 CFR part 20, unless the licensee has demonstrated compliance
with 10 CFR 20.1301 using 10 CFR 20.1302(b)(1) or 10 CFR
20.1302(b)(2)(ii)'' [October 12, 2006, 71 FR 60199]. The concentrations
listed in Table 2 of Appendix B to 10 CFR part 20 apply to radioactive
materials in air and water effluents to unrestricted areas. The NRC
established these concentrations based on an implicit effective dose
equivalent limit of 0.5 mSv/yr (50 mrem/yr) for each medium, assuming
an individual was continuously exposed to the listed concentrations
present in an unrestricted area for a year. If an individual were
continuously exposed for 1 day to concentrations of radioactive
material 5000 times greater than the values listed in Appendix B to 10
CFR part 20, the projected dose would be about 6.8 mSv (680 mrem), or
5,000 x 0.5 mSv/yr x 1 day x 1 yr/365 days. In addition, a release of
radioactive material, from a facility, resulting in these
concentrations, would be expected to cause some contamination of
property in the area affected by the release, with a resultant
potential for further adverse health effects and loss of use. This
contamination would pose a longer-term hazard to members of the public
until it was properly remediated. Depending on the extent of
contamination caused by such a release, the contamination could require
considerable licensee resources to remediate. For these reasons, the
NRC considered the existing AO reporting criterion for discharge or
dispersal of radioactive material as an appropriate consequence
criterion in this rulemaking.
Section 40.81(c)(4). An acute chemical exposure to hazardous
chemicals produced from licensed material at concentrations that
either: (1) Could cause irreversible health effects to a worker, or (2)
could cause notable discomfort to an individual located outside of the
controlled area, is considered an intermediate-consequence event. As
stated in the Sec. 40.81(b)(4) discussion, effects on humans from
acute exposures to chemicals are being developed by a number of
organizations. Two existing standards, AEGL-2 and ERPG-2, can be used
to define the concentration level for irreversible health effects, and
two existing standards, AEGL-1 and ERPG-1, can be used to define the
concentration level for notable discomfort. The qualitative language in
Sec. 40.81(c)(4) allows the applicant/licensee to adopt and propose an
appropriate standard, which may be an AEGL or ERPG standard. Where no
such standard exists, the applicant/licensee may develop or adopt a
criterion that is comparable in severity to those that have been
established for other chemicals.
Section 40.81(d). This provision addresses IROFS and management
measures. Paragraph (d) would require that each engineered or
administrative control or control system that is needed to meet the
performance requirements be designated as an item relied on for safety.
This means that any control or control system that is necessary to
maintain the acceptable combination of consequence and likelihood for
an accident is designated an item relied on for safety. The importance
of this section is that, once a control is designated as an item relied
on for safety, it falls into the envelope of the safety program
required by Sec. 40.82. For example, records will be kept regarding
the item, and management measures such as the configuration control
program are applied to the item and to changes that affect the item, to
ensure that the item will be available and reliable to perform its
function when needed. The failure of an item relied on for safety does
not necessarily mean that an accident will occur which will cause one
of the consequences listed in the performance requirements to be
exceeded.
Some control systems may have parallel (redundant or diverse)
control systems that would continue to prevent the accident. The need
for such defense-in-depth and single-failure resistance would ideally
be based on the severity and likelihood of the potential accident. In
other cases, the failure of an item may mean that the particular
accident sequence is no longer ``highly unlikely,'' or ``unlikely.'' In
these cases, the performance requirement is not met, and the
expectation would be that a management measure would exist (possibly in
the form of an operating procedure) that ensured that the facility
would not operate in a condition that exceeds the performance
requirement. For example, a facility that relies on emergency power
could not operate for an extended time in the absence of an emergency
power source even if grid power is available. In this manner, the IROFS
and the management measures complement each other to ensure adequate
protection from accidents at any given time.
Section 40.81(e). This provision addresses the term ``controlled
area'' as defined in 10 CFR part 20 and as used in the performance
requirements discussed above. Section 40.81(e) requires licensees to
identify a controlled area consistent with the use of that term in 10
CFR part 20, and provides clarification regarding the activities that
may occur inside the controlled area. The function of this term is to
delimit an area over which the licensee exercises control of
activities. Control includes the power to exclude individuals, if
necessary.
The size of the controlled area is not specified in the regulation
because it will be dependent upon the particular activities that are
conducted at the site and their relationship to the licensed
activities. Individuals who do not receive an ``occupational dose'' (as
defined in 10 CFR part 20) in the controlled area will be subject to
the dose limits for members of the public in 10 CFR 20.1301. However,
the Commission recognizes that certain licensees may have ongoing
activities at their site (i.e., within the controlled area) that are
not related to the licensed activities. For example, a non-nuclear
facility may be adjacent to the nuclear facility but both are within
the controlled area (which may be defined similar to the site
boundary). This raises a question regarding the appropriate accident
standard for these individuals.
Protection of members of the public within the controlled area
boundary (e.g., individuals working at a co-located non-nuclear
facility) must consider that the fast-acting nature of many potential
accidents at a UF6 facility covered by these proposed requirements is
such that there will not be sufficient time to evacuate such
individuals from the controlled area. Therefore, for purposes of the
ISA accident evaluation, the rule explicitly contains two options to
adequately protect these individuals (as well as an implicit third
option). For the first option in Sec. 40.81(e)(1), the licensee must
demonstrate, in the ISA, that the risk to members of the public within
the controlled area boundary does not exceed the performance
requirements. For the second option in Sec. 40.81(e)(2), the licensee
must ensure that members of the public within the controlled area
boundary are aware of the risks posed by potential accidents at the
nuclear facility, and have received appropriate training and access to
information. The NRC views the Sec. 40.81(e) requirement as being
consistent with the 10 CFR part 50 definition of ``Exclusion area,''
which states in relevant part that: ``Activities unrelated to operation
of the reactor may be permitted in an exclusion area

[[Page 28345]]

under appropriate limitations, provided that no significant hazards to
the public health and safety will result.''
The implied third option is to define (or redefine) a controlled
area, such that within it, only activities associated with the licensed
nuclear facility are permitted. The NRC's intent is that the ISA need
not evaluate compliance with the accident standards for individuals who
make infrequent visits to the controlled area and restricted area
(e.g., visitors). Use of the ISA to determine the risks to these
individuals would need to consider second-order effects such as the
probability of the individual being present at the time that the
unlikely (or highly unlikely) accident occurred. This level of detail
is unnecessary to accomplish the purpose of this rule (viz., to
document and maintain the safety basis of the facility design and
operations). Application of the 10 CFR part 20 regulations provides
adequate protection for these individuals. In addition, the provisions
(i.e., performance requirements) to protect workers and non-workers
during accidents should, implicitly, provide a degree of protection to
the infrequently present individuals.

Section 40.82 Safety Program and Integrated Safety Analysis

This new section would specify the safety program that licensees
would be required to implement at covered UF6 facilities, including the
performance of an ISA, and establishment of management measures. The
performance of an ISA and the establishment of measures to ensure the
availability and reliability of IROFS when needed are the means by
which licensees would demonstrate an adequate level of protection at
their UF6 facilities. The ISA is a systematic analysis to identify
plant and external hazards and their potential for initiating accident
sequences; the potential accident sequences and their consequences; and
the site, structures, systems, equipment, components, and activities of
personnel relied on for safety. As used here, an ``integrated''
analysis means joint consideration of, and protection from, all
relevant hazards, including radiological, fire, and chemical. The
structure of the safety program recognizes the critical role that the
ISA plays in identifying potential accidents and the IROFS. However, it
also recognizes that the performance of the ISA, by itself, will not
ensure adequate protection. Instead, an effective management system is
needed to ensure that the IROFS are available and reliable to perform
their function when needed. Detailed requirements for each part of the
safety program are included in this section.
Section 40.82(a). Each licensee would be required to establish and
maintain a safety program that demonstrates compliance with the
performance requirements of Sec. 40.81. Although the ISA would be the
primary tool in identifying the potential accidents requiring
consequence mitigation and accident prevention, process safety
information would be used to develop the ISA, and management measures
would be used to ensure the availability and reliability of IROFS
identified through the ISA. The management measures may be graded
according to the risk importance associated with an IROFS.
The licensee is also required to establish and maintain records
demonstrating that it has met, and continues to meet, the requirements
of this section. These records serve two major purposes. First, they
can supplement information that has been submitted as part of the
license application. Second, records are often needed to demonstrate
licensee compliance with applicable regulations and license
commitments. It is important, therefore, that an appropriate system of
recordkeeping be implemented to allow easy retrieval of required
information.
Section 40.82(b). This provision would require the licensee to
maintain process-safety information pertaining to the hazards of the
materials used or produced from licensed materials, the technology of
the process, and the equipment in the process. The NRC's confidence in
the margin of safety at its licensed facilities depends, in part, on
the ability of licensees to maintain a set of current, accurate, and
complete records available for NRC inspection. The process-safety
information should be used in support of development of an ISA.
Section 40.82(c). This provision proposes requirements for
conducting an ISA. There are four major steps in performing an ISA:
(1) Identify all hazards at the facility, including both
radiological and non-radiological hazards. Hazardous materials, their
location, and quantities, should be identified, as well as all
hazardous conditions, such as high temperature and high pressure. In
addition, any interactions that could result in the generation of
hazardous materials or conditions should be identified.
(2) Analyze the hazards to identify how they might result in
potential accidents. These accidents could be caused by process
deviations or other events internal to the plant, or by credible
external events, including natural phenomena such as floods,
earthquakes, etc. To accomplish the task of identifying potential
accidents, the licensee needs to ensure that detailed and accurate
information about plant processes is maintained and made available to
the personnel performing the ISA.
(3) Determine the consequences of each accident that has been
identified. For an accident with consequences at a ``high'' or
``intermediate level,'' as defined in Sec. 40.81, the likelihood of
such an accident must be shown to be commensurate with the
consequences, as required in Sec. 40.81.
(4) Identify the IROFS (i.e., those items that are relied on to
prevent accidents or to mitigate their consequences, identified in the
ISA). These IROFS are needed to reduce the consequences or likelihood
of the accidents to acceptable levels. The identification of IROFS is
required only for accidents with consequences at a high or intermediate
level, as defined in Sec. 40.81.
It is expected that the licensee or applicant would perform the ISA
using a ``team'' of individuals with expertise in engineering and
process operations related to the system being evaluated. The team
should include persons with experience in radiation safety, fire
safety, and chemical process safety, as warranted by the materials and
potential hazards associated with the process being evaluated. At least
one member of the ISA team should be an individual who has experience
and knowledge that is specific to the process being evaluated. Finally,
at least one individual in the team must be knowledgeable in the
specific ISA methodology being used.
Current 10 CFR part 40 licensees covered by the proposed rule would
be required to develop plans and submit them to the NRC within 3 months
of the effective date of the rule. Each plan would identify the
processes that would be subject to an ISA, the ISA approach that would
be implemented for each process and the schedule for completing the
analysis of each process. Licensees would be expected to complete their
ISA within the required time, correct any unacceptable vulnerabilities
identified, and submit the results to the NRC for approval in the form
of an ISA summary that contains the information required by Sec.
40.84(b). Pending the correction of any unacceptable vulnerabilities,
licensees would be expected to implement appropriate compensatory
measures to ensure adequate protection until the

[[Page 28346]]

vulnerability can be more appropriately corrected.
Applicants for licenses to operate new facilities or new processes
at existing facilities would be expected to design their facilities or
processes to protect against the occurrence of the adverse consequences
identified in Sec. 40.81, using the baseline design criteria specified
in Sec. 40.83(a). Before operation, applicants would be expected to
update their ISAs, based on as-built conditions and submit the results
to the NRC as ISA summaries, along with the applications, following the
requirements in Sec. 40.84(b).
Section 40.82(d). This provision proposes requirements to establish
management measures. Although the ISA would play a critical role in
identifying potential accidents and the IROFS, the performance of an
ISA would not, by itself, ensure adequate protection. Thus, in addition
to performing an ISA, management measures need to be established to
ensure that an effective management system is in place such that IROFS
will be available and reliable to perform their function when needed.
As indicated, management measures are functions performed by the
licensee, in general on a continuing basis that are applied to IROFS.
Management measures address topics such as: (a) Configuration
management, (b) maintenance, (c) training and qualifications, (d)
procedures, (e) audits and assessments, (f) incident investigations,
(g) records management, and (h) other quality assurance elements. For
example, changes in a UF6 facility's configuration need to be carefully
controlled to ensure consistency among the facility design and
operational requirements, the physical configuration, and the facility
documentation. Maintenance measures must be in place to ensure the
availability and reliability of all IROFS. Training measures must be
established to ensure that all personnel relied on for safety are
appropriately trained to perform their safety functions. Periodic
audits and assessments of licensee safety programs must be performed to
ensure that facility operations are conducted in a manner that will
adequately protect the worker, the public health and safety, and the
environment. When abnormal events occur, investigations of those events
must be carried out to determine the root cause and identify corrective
actions to prevent their recurrence; this will better ensure that such
events do not lead to more serious consequences. To demonstrate
compliance with NRC regulations, records that document safety program
activities must be maintained for the life of the facility.
The phrase ``when needed'' is used in Sec. 40.82(d) to acknowledge
that a particular safety control need not be continuously functioning.
For example, such a control may not be operational during maintenance
or calibration testing or may not be required when the process is not
operational. But this ``when needed'' concept does not relieve a
licensee from compliance with the performance requirements. For
example, if a particular component is out for maintenance, the licensee
must consider credible event sequences which may occur under the new
conditions, when developing the ISA and identifying IROFS.

Section 40.83 Requirements for New Facilities or New Processes at
Existing Facilities

This new section specifies the baseline design criteria (BDC) that
licensees of new UF6 facilities would be required to meet and that
licensees of existing UF6 facilities would be required to meet when
adding new processes to existing facilities. The BDC are based on the
existing criteria in 10 CFR 70.64.
Section 40.83(a). This provision would specify nine initial safety
design considerations: (1) Quality standards and records; (2) natural
phenomena hazards; (3) fire protection; (4) environmental and dynamic
effects; (5) chemical protection; (6) emergency capability; (7) utility
services; (8) inspection, testing, and maintenance; and (9)
instrumentation and controls. Each proposed BDC is discussed below.
(1) The quality standards and records BDC would need to be
developed and implemented in accordance with management measures.
Management measures that would be applied include the development and
implementation of the design to provide adequate assurance that the
IROFS are adequate and available when called upon. References to
specific, definitive, and adequate commitments in other parts of the
submittal, such as management measures, industry programs, or consensus
standards may be sufficient. Information would need to be provided as
to how appropriate records would be maintained.
(2) The natural phenomena hazards BDC would have to provide for
adequate protection against natural phenomena with consideration of the
most severe documented historical events for the site. The criteria
would have to specifically address how natural phenomena such as
earthquakes and volcanoes, stream flooding, coastal flooding, winds
(including tornadoes), ice and snow loadings, and temperature extremes
were considered in designing the new facility, or adding to an existing
facility.
(3) The fire protection BDC would have to provide for adequate
protection against fires and explosions. As appropriate, the criteria
would need to address how the design considered (a) the use of fire
hazards analyses in the ISA and pre-fire planning; (b) the facility
design in regard to building construction, fire areas, life safety, and
ventilation; (c) process fire safety including explosion protection;
(d) fire protection systems including detection and suppression; and e)
manual fire suppression capability.
(4) The environmental and dynamic effects BDC would have to address
adequate protection from environmental conditions and dynamic effects
associated with normal operations, maintenance, testing, and postulated
accidents that could lead to the loss of safety functions. The design
would have to ensure that IROFS will perform their safety functions
under the environmental and dynamic service conditions in which they
would be required to function and for the length of time their function
would be required. The criteria would also have to include how the
design ensures that non-IROFS will not prevent satisfactory
accomplishment of safety functions of IROFS.
(5) The chemical protection BDC would have to address adequate
protection against chemical risks produced from licensed material,
facility conditions which affect safety of licensed material, and
hazardous chemicals produced from licensed material.
(6) The emergency capability BDC would have to address how the
design of the new facility or process provides for the emergency
capability to maintain control of licensed material and hazardous
chemicals produced from licensed material during an event. It would
also have to address the evacuation of on-site personnel including the
design of the facility to allow personnel to evacuate (e.g., time,
dose, ease of egress) as well as onsite emergency facilities and
services that facilitate the use of available offsite services.
(7) The utility services BDC would have to address how the design
of the new facility or process provides for the continued operation of
essential utility services. Essential utilities are the support systems
that provide for the safety function of the IROFS; e.g., power, air
supply, ventilation. The BDC

[[Page 28347]]

would have to address methods to ensure continued operation of
essential utilities during emergency events.
(8) The inspection, testing, and maintenance BDC would have to
address how the design of the new facility or process provides for
adequate inspection, testing, and maintenance of IROFS to ensure their
availability and reliability to perform their function when needed. The
criteria would need to address the possible methods to provide adequate
inspection, testing, and maintenance to ensure their availability and
reliability. This would need to include the capability for periodic
testing and inspection to assess the operability and performance of
IROFS, the capability to test the functions of IROFS such as active
engineered controls as a completed functioning system and under
appropriate design conditions, and the capability to perform needed
maintenance actions or to identify system or component maintenance
needs to assure availability of IROFS features that are relied upon in
the ISA to meet Sec. 40.81 performance requirements.
(9) The instrumentation and controls BDC would have to address the
inclusion of these systems in the implementation of IROFS. The criteria
would need to include methods to monitor the behavior of IROFS such as
failure detection diagnostics (e.g., information read-out in the
control room or locally for variables) and when the bypass indication
for IROFS is intentionally rendered inoperable.
The BDC are generally an acceptable set of initial design safety
considerations, which may not be sufficient to ensure adequate safety
for all new processes and facilities. The BDC do not provide relief
from compliance with the safety performance requirements of Sec.
40.81. The ISA process is intended to identify additional safety
features that may be needed. On the other hand, the NRC recognizes that
there may be processes or facilities for which some of the BDC may not
be necessary or appropriate, based on the results of the ISA. For these
processes and facilities, any design features that are inconsistent
with the BDC would need to be identified and justified.
Section 40.83(b). This new provision requires licensees to base
their facility and system design and facility layout on practices. The
facility and system design must incorporate, to the extent practicable:
(1) Preference for the selection of engineered controls over
administrative controls to increase overall system reliability, and (2)
features that enhance safety by reducing challenges to IROFS. Using the
BDC and defense-in-depth practices when building new facilities or
adding to existing facilities should result in designs that provide
successive levels of protection such that health and safety will not be
wholly dependent on any single element of the design, construction,
maintenance, or operation of the facility. The net effect of
incorporating defense-in-depth practices is a conservatively designed
facility and system that will exhibit greater tolerance for failures
and external challenges. The risk insights obtained through performance
of the ISA can then be used to supplement the final design by focusing
attention on the prevention and mitigation of potential high-risk
accidents.

Section 40.84 Additional Content of Applications

In addition to the information that currently must be submitted to
NRC under Sec. 40.31, for a license application, this new section
would specify additional information that must be submitted to
demonstrate compliance with the proposed performance requirements. This
additional information includes a description of the applicant's safety
program and management measures established under Sec. 40.82, and an
ISA summary.
Section 40.84(a). This provision would require an applicant to
submit, as part of the license application, a description of the
applicant's safety program established under Sec. 40.82. This is in
addition to what is currently required in Sec. 40.31, Application for
specific license.
Section 40.84(b). This new provision supplements the existing
requirements in Sec. 40.31(j) to capture the additional hazards posed
by operations involving 2000 kg or more of UF6. As previously
discussed, accidents involving UF6 can produce HF, a highly reactive
and corrosive chemical generated in gaseous form when UF6 interacts
with moisture in the air. The HF presents a substantial inhalation and
skin absorption hazard to both workers and the public, as clouds of HF
can quickly move offsite. Thus, licensees authorized to possess 2000 kg
or more of UF6 must either submit an evaluation in accordance with
Sec. 40.31(j)(1)(i) and this new provision or an emergency plan
pursuant to Sec. 40.31(j)(3). Compliance with this new provision would
require the evaluation to also show that an acute chemical exposure
from licensed material or hazardous chemicals produced from licensed
material due to a release would not result in irreversible or mild
transient health effects to a member of the public offsite. In
performing such an evaluation, an applicant/licensee may use an AEGL or
ERPG standard. This approach is currently being used by fuel cycle
facility licensees subject to the 10 CFR part 70 ISA requirements.
Section 40.84(c). This provision would require that an ISA summary
be submitted with the license or renewal application (and amendment
application as necessary). The ISA summary would not be incorporated in
the license.
The ISA summary would have to contain all the items specified
below:
(1) Site: The site description in the ISA Summary will focus on
those factors that could affect safety, such as meteorology (e.g., high
winds and flood potential) and seismology.
(2) Facility: The facility description in the ISA Summary will
focus on areas that could affect safety, and will identify the
controlled area boundaries.
(3) Processes, Hazards and Accident Sequences: The process
description in the ISA Summary must address each process that was
analyzed as part of the ISA. This description must include a list of
the hazards for each process and the accident sequences that could
result from such hazards.
(4) Demonstration of Compliance with Sec. 40.81: The ISA Summary
must demonstrate compliance with the performance requirements, and
describe the management measures.
(5) Team Qualifications and ISA Methods: The ISA Summary must
discuss the applicant's ISA team qualifications and ISA methods.
(6) List of IROFS: The ISA Summary must describe the IROFS for all
intermediate- and high-consequence accidents in sufficient detail to
permit an understanding of their safety function.
(7) Chemical Consequence Standards: The ISA Summary must describe
the proposed quantitative standards for assessing the chemical
consequence levels specified in Sec. 40.81.
(8) List of Sole IROFS: The ISA Summary must identify those IROFS
that are the sole item preventing or mitigating an accident for which
the consequences could exceed the performance requirements of Sec.
40.81.
(9) Definitions of ``Unlikely'', ``Highly Unlikely'' and
``Credible'': The ISA Summary must define the terms ``unlikely,''
``highly unlikely,'' and ``credible,'' as used in the ISA.
The IROFS must be clearly and unambiguously listed in the ISA
summary. This list of items is then managed and controlled by the
applicant/licensee through the

[[Page 28348]]

management measures required by Sec. 40.82(d) to ensure that the IROFS
continue to perform the safety function required. The NRC's review
includes evaluating the ISA methodology, and the ISA summary, and may
be supplemented by reviewing the ISA and other information, as needed,
at the licensee's facility. This enables the NRC to better understand
the potential hazards at the facility, how the applicant plans to
address these hazards, and thereby have confidence in the safety basis
supporting the license.
As previously indicated, the ISA summary would be required to be
submitted on the docket in conjunction with the license application but
would not be considered part of the license. The ISA, on which the ISA
summary is based, would be maintained current at the licensee's
facility and available for NRC review, but it would not be submitted
and docketed. Although the ISA summary will be on the docket, it is not
part of the license and can be changed without a license amendment,
unless it reflects a change that cannot be made without prior approval,
as specified in Sec. 40.86(c) (discussed later in this document).
However, the information used to perform the ISA, and the ISA summary,
both form integral parts of the safety basis for issuance of the
license and therefore must be maintained to adequately represent the
current status of the facility.

Section 40.85 Additional Requirements for Approval of License
Application

This new section would focus on the factors the NRC would use to
determine that requirements in Sec. Sec. 40.80 through 40.85 have been
met. These proposed new regulations are in addition to the existing
licensing regulations being introduced into 10 CFR part 40 under the
new subpart D.
Section 40.85(a). This provision would require the NRC to approve a
license application from an applicant subject to the requirements of
the proposed subpart H if the NRC determines that the applicant has
complied with the requirements of subpart D of 10 CFR part 40 and
Sec. Sec. 40.80 through 40.85.
Section 40.85(b). This provision details the criteria that the NRC
would use for approving ISA-related submissions by existing licensees
(i.e., such submissions will be approved if the integrated safety
analysis approach and the schedule meet the specified requirements).
Section 40.85(c). This provision details the criteria the NRC would
use for approving ISA summaries. These include determining if the
requirements of Sec. 40.84(b) are satisfied and based on the
information in the ISA summary and if the performance requirements in
Sec. 40.81(b), (c) and (d) are satisfied.

Section 40.86 Facility Changes and Change Process

This new section would specify the process for making changes to a
UF6 facility's site, structures, systems, equipment, components, and
activities of personnel after a license application has been approved.
Past incidents at NRC-licensed facilities have been the result of
improperly analyzed changes that were not authorized by licensee
management or changes that were not adequately understood by facility
personnel. Effective control of changes to a facility's site,
structures, systems, equipment, components, and activities of personnel
is a key element in better ensuring safe operation. Under this process,
the licensee can make certain changes without NRC pre-approval. All
changes made pursuant to this section must be reflected promptly in on-
site documents. This approach is the one now applicable to fuel cycle
facilities licensed under 10 CFR part 70.
Section 40.86(a). This provision would require the licensee to
establish a configuration management system documented in written
procedures to track operational changes made by the licensee. The
system would have to assure that prior to implementing any change, its
technical basis, impact on safety and other specified factors are
evaluated.
Section 40.86(b). This provision would require the licensee, before
implementing any change, to determine whether the change requires NRC
pre-approval through the license amendment process.
Section 40.86(c). This provision would specify five types of
changes that could not be implemented without prior NRC approval.
Generally, such changes could have a significant impact on health and
safety.
Section 40.86(d). For changes that are found not to require NRC
pre-approval, the licensee would be required to submit to the NRC
annually, within 30 days after the end of the calendar year, a brief
summary of all such changes. For changes that affect the ISA summary,
the licensee would be required to submit to the NRC annually, within 30
days after the end of the calendar year, revised ISA summary pages.
These yearly updates would allow the NRC staff to maintain relatively
current facility and safety information on the docket and to ensure
that the ISA summary reflects the current configuration of the
facility, thus facilitating the license renewal process (as discussed
further in this document).
Section 40.86(e). Licensees who make changes under the provisions
of this section would be required to promptly up-date all affected on-
site documents.
Section 40.86(f). Records documenting facility changes would be
maintained until termination of the license. Such records would include
a written evaluation providing the bases for the determination that the
changes do not require prior NRC pre-approval.

Section 40.87 Renewal of Licenses

This new section would specify that license renewal applications
may incorporate by reference information contained in previous
applications, statements, or reports filed with the NRC, provided that
these references are clear and specific. In the past, the license
renewal process was burdensome to the NRC and the licensee, because all
changes made to the facility since the last license renewal would be
reviewed at one time. However, maintaining a ``living license,'' as
required by proposed Sec. 40.86, is expected to make the review of
license renewal applications less burdensome since previously approved
information could be incorporated with minimal re-evaluation.

Section 40.88 Additional Reporting Requirements

This new section is based in part on existing Appendix A to 10 CFR
part 70 and would establish event reporting requirements for licensees
required to conduct ISAs. These requirements would become applicable
after the ISA summary had been submitted. The required reports would
have to be made by a knowledgeable licensee representative in a manner
ensuring timely reporting of events, and licensees would have to
provide reasonable assurance that a reliable communication link with
the NRC Operations Center is maintained.
The reporting of events supports the NRC's need to be aware of
conditions that could result in an imminent danger to the worker or to
public health and safety or to the environment. In particular, the NRC
needs to be aware of licensee efforts to address potential emergencies.
Further, once safe conditions have been restored after an event, the
NRC has an interest in disseminating information on the event to the
nuclear industry and other interested parties, to reduce the likelihood
that the event will occur in the future. Also, in the event of an

[[Page 28349]]

accident, the NRC must be able to respond accurately to requests for
information by the public and the media. Event reporting helps the NRC
evaluate the performance of individual licensees and the industry as a
whole in order to fulfill its statutory mandate to protect the health
and safety of the worker and the public.
Section 40.88(a). This provision would require licensees to report
specified events to the NRC Operations Center within 1 hour of their
discovery. These events would be: (1) An acute intake by an individual
of 30 mg or greater of uranium in a soluble form; (2) An acute chemical
exposure to an individual from licensed material or hazardous chemicals
produced from licensed material that are high-consequence events under
the performance requirements; and (3) An event or condition in which no
IROFS remain available and reliable to perform their function. One-hour
reports must be supplemented with additional information as it becomes
available, and must be followed up by a written report to the NRC
within 60 days.
Section 40.88(b). This provision would require licensees to report
specified events to the NRC Operations Center within 24 hours of their
discovery. These events are ones which result in: (1) The facility
being in a state that was not analyzed, was improperly analyzed, or is
different from that analyzed in the ISA, and which causes a failure to
meet the performance requirements; (2) the loss or degradation of one
or more IROFS that causes a failure to meet the performance
requirements; and (3) an acute chemical exposure to an individual from
licensed material or hazardous chemicals produced from licensed
materials that is an intermediate consequence event under the
performance requirements. Additional events that must be reported
within 24 hours of their discovery are fires that have affected or may
have affected one or more IROFS. Twenty-four hour reports must be
supplemented with additional information as it becomes available, and
must be followed up by a written report to the NRC within 60 days.
Section 40.88(c). This provision would pertain to situations
involving a planned news release (or notification to another government
agency) by the licensee, which relates to the health and safety of the
public or onsite personnel. At the same time that the news release (or
notification) is given, the licensee would have to also report the
situation to the NRC Operations Center.
Section 40.88(d). This provision specifies information licensees
would be required to include in their reports called in to the NRC
Operations Center, such as: The caller's name; the date, time, and
exact location of the event being reported; a description of the event;
actions taken in response to the event; and whether the event is
ongoing or has been terminated. The provision would further require
that follow-up information be provided to the NRC Operations Center
until all information required to be reported is complete.
Section 40.88(e). This provision would pertain to the written
reports submitted under Sec. 40.88(a) and (b). In addition to
including the information required by Sec. 40.88(d)(1), written
reports would include: A discussion of the probable cause of the event,
specific information regarding any equipment that failed or
malfunctioned, any corrective actions taken to prevent future similar
events, the results of any evaluations or assessments of the event, and
a discussion of whether the event was previously identified and
evaluated in the ISA.

Section 40.89 Backfitting

This new section would establish backfit requirements similar to
those in Sec. 70.76. These requirements would apply to the subset of
10 CFR part 40 licensees authorized to possess significant quantities
(2000 kilograms or more) of UF6. The backfit provision is being added
in accordance with the Commission SRM dated November 30, 2010.
Section 40.89(a). This provision would make the backfit
requirements applicable to licensees authorized to possess 2000
kilograms (4400 lb) or more of UF6, and its terms would become
effective once such a licensee's ISA summary has been approved by the
NRC. The proposed backfit requirements would not be applicable to 10
CFR part 40 licensees who are not authorized to possess 2000 kilograms
or more of UF6.
Section 40.89(b). This provision would define backfitting as the
modification of, or addition to: (1) Systems, structures, or components
of a facility of a licensee subject to ISA requirements; or (2) the
procedures or organization required to operate such a facility; any of
which may result from a new or amended provision in the Commission
rules or the imposition of a regulatory staff position interpreting the
Commission rules that is either new or different from a previous NRC
staff position. This proposed definition is substantially similar as
the one in existing Sec. 70.76(a)(1).
Section 40.89(c). This provision contains identical backfit
analysis requirements as in the existing Sec. 70.76(a)(2) through
(a)(7). Exceptions to requiring a backfit analysis would be listed in
this provision and include: (1) Modifications necessary to bring a
facility into compliance with subpart H, a license, the rules or orders
of the Commission, or into conformance with written commitments by the
licensee; (2) regulatory action necessary to ensure adequate protection
to the health and safety of the public and is in accord with the common
defense and security; or (3) the regulatory action involves defining or
redefining what level of protection to the public health and safety or
common defense and security should be regarded as adequate.
Other provisions in proposed Sec. 40.89(c): (1) Would require the
Commission to require backfitting of a facility if it is necessary to
ensure adequate protection to the health and safety of the public; (2)
would require the Commission to include a statement of the objectives
and reasons for modifications when invoking the exception under Sec.
40.89(a)(3); and (3) would allow, in most cases, for the licensee to
choose its own way to achieve compliance with a license or the rules or
orders of the Commission, or with written license commitments provided
that the objective of compliance or adequate protection is met.
Section 40.89(d). This provision would require the Commission, in
the determinations required by Paragraph (a)(2) of this section, to
consider how the backfit would be scheduled in light of other ongoing
regulatory activities at the facility, and follows the existing
requirements in Sec. 70.76(b). Additionally, this provision would
require the Commission to consider specific information relevant to the
backfit. These factors include: (1) The potential change in the risk to
the public from the accidental release of radioactive material and
hazardous chemicals produced from such material, and (2) the potential
impact on facility employees from exposure to radioactive material and
to hazardous chemicals produced from such material.
Section 40.89(e). This provision would prohibit withholding a
license during the backfit analyses and is the same as existing Sec.
70.76(c).
Section 40.89(f). This provision is the same as existing Sec.
70.76(d) and would designate the Executive Director for Operations as
the party responsible for its implementation. Additionally, it would
require that all backfit analyses be approved by the Executive Director
for Operations or his or her designee.

[[Page 28350]]

Section 40.102 Criminal Penalties

Existing Sec. 40.82 would be re-designated as Sec. 40.102.
Additionally, Paragraph (b) of this section would be amended to add the
applicable sections in the new subpart H and to reflect the
administrative renumbering of 10 CFR part 40.

Section 150.15 Persons Not Exempt

A new Paragraph (a)(10) would be added to support the NRC's
determination that licensees who possess or plan to possess 2000 kg or
more of UF6 would be exclusively under the NRC's jurisdiction. Since
the events of September 11, 2001, major nuclear facilities with
hazardous radioactive or chemical materials have received increased
security oversight to address the potential heightened threat of
sabotage and terrorist attacks. The complex procedural operations at
these facilities involve hazardous chemicals as well as nuclear
material, making it difficult to separate the additional common defense
and security requirements from the program requirements designed to
protect public health and safety. The NRC is the only regulatory
agency, under the AEA, that is authorized to implement such a unified
program.

V. Criminal Penalties

For the purpose of Section 223 of the AEA, the Commission is
proposing to amend 10 CFR part 40 under one or more of Sections 161b,
161i, or 161o of the AEA. Willful violations of the rule would be
subject to criminal enforcement.

VI. Agreement State Compatibility

This proposed rule applies only to NRC licensees and therefore
contains no components that have Agreement State compatibility.

VII. Plain Language

The Presidential Memorandum ``Plain Language in Government
Writing'' published June 10, 1998 (63 FR 31883), directed that the
Government's documents be in clear and accessible language. The NRC
requests comments on this proposed rule specifically with respect to
the clarity and effectiveness of the language used. Comments should be
sent to the address listed under the ADDRESSES section of this
document.

VIII. Voluntary Consensus Standards

The National Technology Transfer and Advancement Act of 1995 (Pub.
L. 104-113) requires that Federal agencies use technical standards that
are developed or adopted by voluntary consensus standards bodies,
unless the use of such a standard is inconsistent with applicable law
or otherwise impractical. In this proposed rule, the NRC would add
performance requirements to fuel cycle facilities regulated by 10 CFR
part 40 similar to the performance requirements for fuel cycle
facilities regulated by 10 CFR part 70. The NRC is not aware of any
voluntary consensus standards that address the proposed subject matter
of this proposed rule. The NRC will consider using a voluntary
consensus standard if an appropriate standard is identified. If a
voluntary consensus standard is identified for consideration, the
submittal should explain why the standard should be used.

IX. Environmental Impact: Categorical Exclusion

The Commission has determined under the National Environmental
Policy Act of 1969, as amended, and the Commission's regulations in
subpart A of 10 CFR part 51, not to prepare an environmental impact
statement for this proposed rule, because the Commission has concluded
on the basis of an environmental assessment that this proposed rule, if
adopted, would not be a major Federal action significantly affecting
the quality of the human environment.
Licensees are required to protect against the occurrence of or to
mitigate the consequences of accidents that could adversely affect
workers, the public, or the environment. Implementation of the proposed
amendments, including the requirement to protect against events that
could damage the environment, is expected to result in a significant
improvement in licensees', NRC's, other governmental agencies', and the
public's understanding of the risks at these facilities and licensees'
ability to ensure that those risks are appropriately controlled. For
existing licensees, any deficiencies identified in the ISA would need
to be promptly addressed. For new licensees, operations will not begin
unless licensees demonstrate an adequate level of protection against
potential accidents identified in the ISA. As a result, the safety and
environmental impact of the new amendments is positive. There would be
less potential adverse impact on the environment from licensed
operations carried out under the final rule than if those operations
were carried out under the existing 10 CFR part 40 regulation.
The determination of this environmental assessment is that there
will be no significant impact to the public from this action. However,
the general public should note that the NRC welcomes public
participation. Comments on any aspect of the Environmental Assessment
may be submitted to the NRC by the following methods: (1) Mail comments
to Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-
0001, ATTN: Rulemakings and Adjudications Staff; (2) e-mail comments to
Rulemaking.Comments@nrc.gov; (3) hand deliver comments to 11555
Rockville Pike, Rockville, MD 20852, between 7:30 a.m. and 4:15 p.m.
Federal workdays (telephone 301-415-1677); or (4) fax comments to
Secretary, U.S. Nuclear Regulatory Commission at 301-415-1101.
The NRC has sent a copy of the Environmental Assessment and this
proposed rule to every State Liaison Officer and requested their
comments on the Environmental Assessment. The Environmental Assessment
may be examined at the NRC's PDR, O-1F21, 11555 Rockville Pike,
Rockville, MD 20852. The environmental assessment is available
electronically under ADAMS Accession Number ML102380248.

X. Paperwork Reduction Act Statement

This proposed rule contains new or amended information collection
requirements that are subject to the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq). This rule has been submitted to the Office of
Management and Budget (OMB) for approval of the information collection
requirements.
Type of submission, new or revision: Revision.
The title of the information collection: 10 CFR part 40--Integrated
Safety Analysis, Proposed Rule.
The form number if applicable: N/A.
How often the collection is required: One hour, 24 hours, 60 days
and annually.
Who will be required or asked to report: Licensees Authorized to
Possess 2000 Kilograms (4400 lb) or More of Uranium Hexafluoride.
An estimate of the number of annual responses: 7.4.
The estimated number of annual respondents: 1.
An estimate of the total number of hours needed annually to
complete the requirement or request: 295.
Abstract: The NRC is proposing to amend its regulations to amend 10
CFR part 40 to require current licensees and future applicants who are
authorized to possess 2000 kilograms or more of uranium hexafluoride to
perform an ISA. The proposed amendments would require licensees to
submit several one-time reports including a plan of action and an ISA
summary. Annual reporting

[[Page 28351]]

requirements would be reduced by this proposed rulemaking by allowing
the licensees to amend aspects of their licenses through the ISA
process without a formal amendment request to the NRC. Record keeping
burden would be increased by the requirement to perform an ISA and
document changes to it as well as records of training and other
necessary actions. Event reporting under this proposed rule would
require licensees to report at 1 hour, 24 hours, and 60 day intervals.
The information included in the applications, reports and records
required by the proposed rule would be mandatory and would be reviewed
by the NRC staff to assess the adequacy of the applicant's or
licensee's physical plant, equipment, organization, training,
experience, procedures and plans for protection of public health and
safety.
The NRC is seeking public comment on the potential impact of the
information collections contained in this proposed rule and on the
following issues:
1. Is the proposed information collection necessary for the proper
performance of the functions of the NRC, including whether the
information will have practical utility?
2. Is the estimate of burden accurate?
3. Is there a way to enhance the quality, utility, and clarity of
the information to be collected?
4. How can the burden of the information collection be minimized,
including the use of automated collection techniques?
The public may examine and have copied, for a fee, publicly
available documents, including the draft supporting statement, at the
NRC's PDR, One White Flint North, 11555 Rockville Pike, Room O-1 F21,
Rockville, Maryland 20852. The OMB clearance package and rule are
available at the NRC's Web site, http://www.nrc.gov/public-involve/doc-comment/omb/index.html, for 60 days after the signature date of this
notice.
Send comments on any aspect of these proposed regulations related
to information collections, including suggestions for reducing the
burden and on the issues previously discussed in this section, by June
16, 2011 to the Records and FOIA/Privacy Services Branch (T-5 F53),
U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, or by
Internet electronic mail to Infocollects.Resources@NRC.gov and to the
Desk Officer, Office of Information and Regulatory Affairs, NEOB-10202
3150-0020, Office of Management and Budget, Washington, DC 20503.
Comments on the proposed information collections may also be submitted
via the Federal rulemaking Web site, http://www.regulations.gov, Docket
ID NRC-2009-0079. Comments received after this date will be considered
if it is practical to do so, but assurance of consideration cannot be
given to comments received after this date.

Public Protection Notification

The NRC may not conduct or sponsor, and a person is not required to
respond to, a request for information or an information collection
requirement unless the requesting document displays a currently valid
OMB control number.

XI. Regulatory Analysis

The Commission has prepared a draft regulatory analysis on this
proposed regulation. The analysis examines the costs and benefits of
the alternatives considered by the Commission.
The Commission requests public comment on the draft regulatory
analysis. Comments on the draft regulatory analysis may be submitted to
the NRC by the following methods: (1) Mail comments to Secretary, U.S.
Nuclear Regulatory Commission, Washington, DC 20555-0001, ATTN:
Rulemakings and Adjudications Staff; (2) e-mail comments to
Rulemaking.Comments@nrc.gov; (3) hand deliver comments to 11555
Rockville Pike, Rockville, MD 20852, between 7:30 a.m. and 4:15 p.m.
Federal workdays (telephone 301-415-1677); or (4) fax comments to
Secretary, U.S. Nuclear Regulatory Commission at 301-415-1101.
The analysis is available for inspection in the NRC's PDR, One
White Flint North, 11555 Rockville Pike, Room O-1 F21, Rockville,
Maryland 20852. The draft regulatory analysis is available
electronically under ADAMS Accession Number ML102380248.

XII. Regulatory Flexibility Certification

In accordance with the Regulatory Flexibility Act of 1980 (5 U.S.C.
605(b)), the Commission certifies that this rule would not, if
promulgated, have a significant economic impact on a substantial number
of small entities. The majority of companies that own these plants do
not fall within the scope of the definition of ``small entities'' set
forth in the Regulatory Flexibility Act or the size standards
established by the NRC (10 CFR 2.810).

XIII. Backfit Analysis

The backfit rule (which is found in the regulations at Sec. Sec.
50.109, 70.76, 72.62, 76.76, and in 10 CFR part 52) does not apply to
this proposed rule. Title 10 of the CFR part 40 does not contain a
backfit requirement. Therefore, a backfit analysis is not required.

List of Subjects

10 CFR Part 40

Criminal penalties, Government contracts, Hazardous materials
transportation, Nuclear materials, Reporting and recordkeeping
requirements, Source material, Uranium.

10 CFR Part 150

Criminal penalties, Hazardous materials transportation,
Intergovernmental relations, Nuclear materials, Reporting and
recordkeeping requirements, Security measures, Source material, Special
nuclear material.

For the reasons set out in the preamble and under the authority of
the Atomic Energy Act of 1954, as amended; the Energy Reorganization
Act of 1974, as amended; and 5 U.S.C. 553; the NRC is proposing to
adopt the following amendments to 10 CFR parts 40 and 150.

PART 40--DOMESTIC LICENSING OF SOURCE MATERIAL

1. The authority citation for part 40 continues to read as follows:

Authority: Secs. 62, 63, 64, 65, 81, 161, 182, 183, 186, 68
Stat. 932, 933, 935, 948, 953, 954, 955, as amended, secs. 11e(2),
83, 84, Pub. L. 95-604, 92 Stat. 3033, as amended, 3039, sec. 234,
83 Stat. 444, as amended (42 U.S.C. 2014(e)(2), 2092, 2093, 2094,
2095, 2111, 2113, 2114, 2201, 2232, 2233, 2236, 2282); sec. 274,
Pub. L. 86-373, 73 Stat. 688 (42 U.S.C. 2021); secs. 201, as
amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C.
5841, 5842, 5846); sec. 275, 92 Stat. 3021, as amended by Pub. L.
97-415, 96 Stat. 2067 (42 U.S.C. 2022); sec. 193, 104 Stat. 2835, as
amended by Pub. L. 104-134, 110 Stat. 1321, 1321-349 (42 U.S.C.
2243); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 note); Energy
Policy Act of 2005, Pub. L. 109-59, 119 Stat. 594 (2005).
Section 40.7 also issued under Pub. L. 95-601, sec. 10, 92 Stat.
2951 as amended by Pub. L. 102-486, sec. 2902, 106 Stat. 3123 (42
U.S.C. 5851). Section 40.31(g) also issued under sec. 122, 68 Stat.
939 (42 U.S.C. 2152). Section 40.46 also issued under sec. 184, 68
Stat. 954, as amended (42 U.S.C. 2234). Section 40.71 also issued
under sec. 187, 68 Stat. 955 (42 U.S.C. 2237).

Subpart A--General Provisions

2. The undesignated subject heading that precedes Sec. 40.1 is
designated as ``Subpart A-General Provisions''.
3. A new Sec. 40.3a is added to read as follows:

[[Page 28352]]

Sec. 40.3a Denial of licensing by Agreement States.

After [insert effective date of final rule], Agreement States may
not issue new licenses covering the possession of 2000 kilograms (4400
lb) or more of uranium hexafluoride.
4. In Sec. 40.4, the definitions Acute, Available and reliable to
perform their function when needed, Configuration management, Defense-
in-depth practices, Hazardous chemicals produced from licensed
material, Integrated safety analysis, Integrated safety analysis
summary, Items relied on for safety, Management measures, Unacceptable
performance deficiencies, and Worker are added in alphabetical order to
read as follows:

Sec. 40.4 Definitions.

* * * * *
Acute, as used in this part, means a single radiation dose or
chemical exposure event or multiple radiation dose or chemical exposure
events occurring within a short time (24 hours or less).
* * * * *
Available and reliable to perform their function when needed, as
used in subpart H of this part, means that, based on the analyzed,
credible conditions in the integrated safety analysis, items relied on
for safety will perform their intended safety function when needed, and
management measures will be implemented that ensure compliance with the
performance requirements of Sec. 40.81, considering factors such as
necessary maintenance, operating limits, common-cause failures, and the
likelihood and consequences of failure or degradation of the items and
measures.
* * * * *
Configuration management means a management measure that provides
oversight and control of design information, safety information, and
records of modifications (both temporary and permanent) that might
impact the ability of items relied on for safety to perform their
functions when needed.
* * * * *
Defense-in-depth practices means a design philosophy, applied from
the outset and through completion of the design, that is based on
providing successive levels of protection such that health and safety
will not be wholly dependent upon any single element of the design,
construction, maintenance, or operation of the facility. The net effect
of incorporating defense-in-depth practices is a conservatively
designed facility and system that will exhibit greater tolerance to
failures and external challenges. The risk insights obtained through
performance of the integrated safety analysis can then be used to
supplement the final design by focusing attention on the prevention and
mitigation of the higher-risk potential accidents.
* * * * *
Hazardous chemicals produced from licensed materials means
substances having licensed material as precursor compound(s) or
substances that physically or chemically interact with licensed
materials; and that are toxic, explosive, flammable, corrosive, or
reactive to the extent that they can endanger life or health if not
adequately controlled. These include substances commingled with
licensed material, and include substances such as hydrogen fluoride
that is produced by the reaction of uranium hexafluoride and water, but
do not include substances prior to process addition to licensed
material or after process separation from licensed material.
Integrated safety analysis means a systematic analysis to identify
facility and external hazards and their potential for initiating
accident sequences, the potential accident sequences, their likelihood
and consequences, and the items relied on for safety. As used here,
integrated means joint consideration of, and protection from, all
relevant hazards, including radiological, fire, and chemical. The NRC's
ISA requirement is limited to consideration of the effects of all
relevant hazards on radiological safety or chemical hazards directly
associated with NRC licensed radioactive material. An integrated safety
analysis can be performed process by process, but all processes must be
integrated, and process interactions considered.
Integrated safety analysis summary means a document or documents
submitted with the license application, license amendment application,
license renewal application, or pursuant to Sec. 40.82(c)(3)(ii) that
provides a synopsis of the results of the integrated safety analysis
and contains the information specified in Sec. 40.84(b). The
integrated safety analysis summary can be submitted as one document for
the entire facility, or as multiple documents that cover all relevant
portions and processes of the facility.
Items relied on for safety mean structures, systems, equipment,
components, and activities of personnel that are relied on to prevent
potential accidents at a facility that could exceed the performance
requirements in Sec. 40.81 or to mitigate their potential
consequences. This does not limit the licensee from identifying
additional structures, systems, equipment, components, or activities of
personnel (i.e., beyond those in the minimum set necessary for
compliance with the performance requirements) as items relied on for
safety.
* * * * *
Management measures mean the functions performed by the licensee,
generally on a continuing basis, that are applied to items relied on
for safety, to ensure the items are available and reliable to perform
their functions when needed. Management measures include configuration
management, maintenance, training and qualifications, procedures,
audits and assessments, incident investigations, records management,
and other quality assurance elements.
* * * * *
Unacceptable performance deficiencies mean deficiencies in the
items relied on for safety or the management measures that need to be
corrected to ensure an adequate level of protection as defined in Sec.
40.81(b) or (c).
* * * * *
Worker, when used in subpart H of this part, means an individual
who receives an occupational dose as defined in Sec. 20.1003 of this
chapter.
5. In Sec. 40.8, paragraph (b) is revised to read as follows:

Sec. 40.8 Information collection requirements: OMB approval.

* * * * *
(b) The approved information collection requirements contained in
this part appear in Sec. Sec. 40.9, 40.23, 40.25, 40.26, 40.27, 40.31,
40.35, 40.36, 40.41, 40.42, 40.43, 40.44, 40.51, 40.60, 40.61, 40.64,
40.65, 40.66, 40.67, 40.80, 40.81, 40.82, 40.83, 40.84, 40.86, 40.87,
40.88, 40.89, and appendix A to this part.
* * * * *

Subpart B--General Licenses

6. The undesignated subject heading that precedes Sec. 40.20 is
designated as ``Subpart B--General Licenses''.
7. In Sec. 40.26, paragraph (c)(1) is revised to read as follows:

Sec. 40.26 General license for possession and storage of byproduct
material as defined in this part.

* * * * *
(c) * * *
(1) The provisions of parts 19, 20, and 21 of this chapter, and
Sec. Sec. 40.1, 40.2a, 40.3, 40.4, 40.5, 40.6, 40.41, 40.46, 40.60,
40.61, 40.62, 40.63, 40.65, 40.71, and 40.101; and
* * * * *

[[Page 28353]]

Subpart C--License Applications

8. The undesignated subject heading that precedes Sec. 40.31 is
designated as ``Subpart C--License Applications''.

Subpart D--Licenses

9. The undesignated subject heading that precedes Sec. 40.41 is
designated as ``Subpart D--Licenses''.

Subpart E--Transfer of Source Material

10. The undesignated subject heading that precedes Sec. 40.51 is
designated as ``Subpart E--Transfer of Source Material''.

Subpart F--Records, Reports, and Inspections

11. The undesignated subject heading that precedes Sec. 40.60 is
designated as ``Subpart F--Records, Reports, and Inspections''.

Subpart G--Modification and Revocation of Licenses

12. The undesignated subject heading that precedes Sec. 40.71 is
designated as ``Subpart G--Modification and Revocation of Licenses''.

Subpart I--Enforcement

Sec. 40.81 and 40.82 [Redesignated as Sec. Sec. 40.101 and 40.102].

13. Sections 40.81 and 40.82 are redesignated as Sec. Sec. 40.101
and 40.102, respectively.
14. The undesignated subject heading that precedes the newly
designated Sec. 40.101 is designated as ``Subpart I--Enforcement''.
15. In the newly redesignated Sec. 40.102, paragraph (b) is
revised to read as follows:

Sec. 40.102 Criminal penalties.

* * * * *
(b) The regulations in part 40 that are not issued under sections
161b, 161i, or 161o for the purposes of section 223 are as follows:
Sec. Sec. 40.1, 40.2, 40.2a, 40.4, 40.5, 40.6, 40.8, 40.11, 40.12,
40.13, 40.14, 40.20, 40.21, 40.31, 40.32, 40.34, 40.43, 40.44, 40.45,
40.71, 40.85, 40.87, 40.101, and 40.102.
16. A new subpart H is added after Sec. 40.71 to read as follows:
Subpart H--Additional Requirements for Certain Licensees Authorized to
Possess 2000 Kilograms (4400 lb) or More of Uranium Hexafluoride
Sec.
40.80 Applicability.
40.81 Performance requirements.
40.82 Safety program and integrated safety analysis.
40.83 Requirements for new facilities or new processes at existing
facilities.
40.84 Additional content of applications.
40.85 Additional requirements for approval of license application.
40.86 Facility changes and change process.
40.87 Renewal of licenses.
40.88 Additional reporting requirements.
40.89 Backfitting.

Subpart H--Additional Requirements for Certain Licensees Authorized
to Possess 2000 Kilograms (4400 lb) or More of Uranium Hexafluoride

Sec. 40.80 Applicability.

The regulations in this subpart apply, in addition to other
applicable Commission regulations, to each applicant or licensee that
is or plans to be authorized to possess 2000 kilograms (4400 lb) or
more of uranium hexafluoride. The regulations in this subpart do not
apply to licensees that are undergoing decommissioning under the
provisions of Sec. 40.42 on [Insert the effective date of this
regulation].

Sec. 40.81 Performance requirements.

(a) Each applicant or licensee must evaluate, in the integrated
safety analysis performed in accordance with Sec. 40.82, its
compliance with the performance requirements in paragraphs (b), (c),
and (d) of this section.
(b) The risk of each credible high-consequence event must be
limited. Engineered controls, administrative controls, or both, subject
to Sec. 40.83(b)(1), must be applied to the extent needed to reduce
the likelihood of occurrence of the event so that, upon implementation
of such controls, the event is highly unlikely or its consequences are
less severe than those in paragraphs (b)(1) through (b)(4) of this
section. High consequence events are those internally or externally
initiated events that result in:
(1) An acute worker dose of 1 Sv (100 rem) or greater total
effective dose equivalent;
(2) An acute dose of 0.25 Sv (25 rem) or greater total effective
dose equivalent to any individual located outside the controlled area
as specified in paragraph (e) of this section;
(3) An intake of 30 mg or greater of uranium in soluble form by any
individual located outside the controlled area as specified in
paragraph (e) of this section; or
(4) An acute chemical exposure to an individual from licensed
material or hazardous chemicals produced from licensed material that:
(i) Could endanger the life of a worker; or
(ii) Could lead to irreversible or other serious, long-lasting
health effects to any individual located outside the controlled area as
specified in paragraph (e) of this section. If an applicant or licensee
possesses or plans to possess quantities of material capable of such
chemical exposures, then the applicant or licensee must propose
appropriate quantitative standards for these health effects, as part of
the information submitted under Sec. 40.84.
(c) The risk of each credible intermediate-consequence event must
be limited. Engineered controls, administrative controls, or both must
be applied to the extent needed so that, upon implementation of such
controls, the event is unlikely or its consequences are less than those
in paragraphs (c)(1) through (c)(4) of this section. Intermediate
consequence events are those internally or externally initiated events
that are not high consequence events that result in:
(1) An acute worker dose of 0.25 Sv (25 rem) or greater total
effective dose equivalent;
(2) An acute dose of 0.05 Sv (5 rem) or greater total effective
dose equivalent to any individual located outside the controlled area
as specified in paragraph (e) of this section;
(3) A 24-hour averaged release of radioactive material outside the
restricted area in concentrations exceeding 5000 times the values in
Table 2 of Appendix B to part 20 of this chapter; or
(4) An acute chemical exposure to an individual from licensed
material or hazardous chemicals produced from licensed material that:
(i) Could lead to irreversible or other serious, long-lasting
health effects to a worker; or
(ii) Could cause mild transient health effects to any individual
located outside the controlled area as specified in paragraph (e) of
this section. If an applicant or licensee possesses or plans to possess
quantities of material capable of such chemical exposures, then the
applicant or licensee must propose appropriate quantitative standards
for these health effects, as part of the information submitted under
Sec. 40.84.
(d) Each engineered or administrative control or control system
necessary to comply with paragraphs (b), (c), or (d) of this section
must be designated as an item relied on for safety. The safety program,
established and maintained under Sec. 40.82, must ensure that each
item relied on for safety will be available and reliable to perform its
intended function when needed and in the context of the performance
requirements of this section.
(e) Each licensee must establish a controlled area, as defined in
Sec. 20.1003 of this chapter. In addition, the licensee must retain
the authority to exclude or

[[Page 28354]]

remove personnel and property from the area. For the purpose of
complying with the performance requirements of this section,
individuals who are not workers, as defined in Sec. 40.4, may be
permitted to perform ongoing activities (e.g., at a facility not
related to the licensed activities) in the controlled area, if the
licensee:
(1) Demonstrates and documents, in the integrated safety analysis,
that the risk for those individuals at the location of their activities
does not exceed the performance requirements of paragraphs (b)(2),
(b)(3), (b)(4)(ii), (c)(2), and (c)(4)(ii) of this section; or
(2) Provides training to these individuals that satisfies the
requirements of Sec. 19.12(a)(1) through (a)(5) of this chapter and
ensures that they are aware of the risks associated with accidents
involving the licensed activities as determined by the integrated
safety analysis, and conspicuously posts and maintains notices stating
where these individuals may examine the information contained in Sec.
19.11(a) of this chapter. Under these conditions, the performance
requirements for workers specified in paragraphs (b) and (c) of this
section may be applied to these individuals.

Sec. 40.82 Safety program and integrated safety analysis.

(a) Safety program. (1) Each licensee or applicant must establish
and maintain a safety program that demonstrates compliance with the
performance requirements of Sec. 40.81. The safety program may be
graded such that management measures applied are graded commensurate
with the reduction of the risk attributable to that item. Three
elements of this safety program, namely, process safety information,
integrated safety analysis, and management measures, are described in
paragraphs (b) through (d) of this section.
(2) Each licensee or applicant must establish and maintain records
that demonstrate compliance with the requirements of paragraphs (b)
through (d) of this section.
(3) Each licensee or applicant must maintain records of failures
readily retrievable and available for NRC inspection, documenting each
discovery that an item relied on for safety or management measure has
failed to perform its function upon demand or has degraded such that
the performance requirements of Sec. 40.81 are not satisfied. These
records must identify the item relied on for safety or management
measure that has failed and the safety function affected, the date of
discovery, date (or estimated date) of the failure, duration (or
estimated duration) of the time that the item was unable to perform its
function, any other affected items relied on for safety or management
measures and their safety function, affected processes, cause of the
failure, whether the failure was in the context of the performance
requirements or upon demand or both, and any corrective or compensatory
action that was taken. A failure must be recorded at the time of
discovery and the record of that failure updated promptly upon the
conclusion of each failure investigation of an item relied on for
safety or management measure.
(b) Process safety information. Each licensee or applicant must
maintain process safety information to enable the performance and
maintenance of an integrated safety analysis. This process safety
information must include information pertaining to the hazards of the
materials used or produced in the process, information pertaining to
the technology of the process, and information pertaining to the
equipment in the process.
(c) Integrated safety analysis--(1) Requirements. Each licensee or
applicant shall conduct and maintain an integrated safety analysis that
is of appropriate detail for the complexity of the process and
identifies:
(i) Radiological hazards related to possessing or processing
licensed material at its facility;
(ii) Chemical hazards of licensed material and hazardous chemicals
produced from licensed material;
(iii) Facility hazards that could affect the safety of licensed
materials and thus present an increased risk due to licensed material
or hazardous chemicals produced from licensed material;
(iv) Potential accident sequences caused by process deviations or
other events internal to the facility and credible external events,
including natural phenomena;
(v) The consequence and the likelihood of occurrence of each
potential accident sequence as specified in paragraph (c)(1)(iv) of
this section, and the methods used to determine the consequences and
likelihoods; and
(vi) Each item relied on for safety as specified in Sec. 40.81(d),
the characteristics of its preventive, mitigative, or other safety
function, and the assumptions and conditions under which the item is
relied upon to support compliance with the performance requirements of
Sec. 40.81.
(2) Integrated safety analysis team qualifications. To assure the
adequacy of the integrated safety analysis, the analysis must be
performed by a team with expertise in engineering and process
operations. The team must include at least one person who has
experience and knowledge specific to each process being evaluated, and
persons who have experience in radiation safety, fire safety, and
chemical process safety. One member of the team must be knowledgeable
in the specific integrated safety analysis methodology being used.
(3) Requirements for existing licensees. Individuals holding an NRC
license on [insert effective date of final rule] shall, with regard to
existing licensed activities:
(i) Submit for NRC approval, within [insert date six months after
the effective date of final rule], a plan that describes the integrated
safety analysis approach that will be used, the processes that will be
analyzed, and the schedule for completing the analysis of each process.
(ii) Complete an integrated safety analysis within [insert date 18
months after effective date of final rule], unless an approved plan
submitted under paragraph (c)(3)(i) of this section, authorizes an
alternative schedule.
(iii) Submit for NRC approval, an integrated safety analysis
summary within [insert date 18 months after effective date of final
rule], unless an approved plan submitted under paragraph (c)(3)(i) of
this section, authorizes an alternative schedule. The integrated safety
analysis summary must include a description of the management measures
identified in this section.
(iv) Correct all unacceptable performance deficiencies within
[insert date 3 years after effective date of final rule]. The
Commission may approve a request for an alternative schedule for
completing the correction of unacceptable performance deficiencies if
the Commission determines that the alternative is warranted by
consideration of the following:
(A) Adequate compensatory measures have been established;
(B) Whether it is technically feasible to complete the correction
of the unacceptable performance deficiencies within the required time;
(C) Other site-specific factors which the Commission may consider
appropriate on a case-by-case basis and that are beyond the control of
the licensee.
(v) Pending the correction of unacceptable performance deficiencies
identified during the conduct of the integrated safety analysis, the
licensee must implement appropriate compensatory measures to ensure
adequate protection.

[[Page 28355]]

(d) Management measures. Each applicant or licensee must establish
management measures to ensure compliance with the performance
requirements of Sec. 40.81. The measures applied to a particular
engineered or administrative control or control system may be graded
commensurate with the reduction of the risk attributable to that
control or control system. The management measures must ensure that
engineered and administrative controls and control systems that are
identified as items relied on for safety pursuant to Sec. 40.81(d) are
designed, implemented, and maintained, as necessary, to ensure they are
available and reliable to perform their function when needed, to comply
with the performance requirements of Sec. 40.81.

Sec. 40.83 Requirements for new facilities or new processes at
existing facilities.

(a) Baseline design criteria. Each prospective applicant or
licensee must address the following baseline design criteria in the
design of new facilities. Each existing licensee must address the
following baseline design criteria in the design of new processes at
existing facilities that require a license amendment under Sec. 40.86.
The baseline design criteria must be applied to the design of new
facilities and new processes, but do not require retrofits to existing
facilities or existing processes (e.g., those housing or adjacent to
the new process); however, all facilities and processes must comply
with the performance requirements in Sec. 40.81. Licensees must
maintain the application of these criteria unless the analysis
performed as specified in Sec. 40.82(c) demonstrates that a given item
is not relied on for safety or does not require adherence to the
specified criteria.
(1) Quality standards and records. The design must be developed and
implemented in accordance with management measures, to provide adequate
assurance that items relied on for safety will be available and
reliable to perform their function when needed. Appropriate records of
these items must be maintained by or under the control of the licensee
throughout the life of the facility.
(2) Natural phenomena hazards. The design must provide for adequate
protection against natural phenomena with consideration of the most
severe documented historical events for the site.
(3) Fire protection. The design must provide for adequate
protection against fires and explosions.
(4) Environmental and dynamic effects. The design must provide for
adequate protection from environmental conditions and dynamic effects
associated with normal operations, maintenance, testing, and postulated
accidents that could lead to loss of safety functions.
(5) Chemical protection. The design must provide for adequate
protection against chemical risks produced from licensed material,
facility conditions which affect the safety of licensed material, and
hazardous chemicals produced from licensed material.
(6) Emergency capability. The design must provide for emergency
capability to maintain control of:
(i) Licensed material and hazardous chemicals produced from
licensed material;
(ii) Evacuation of on-site personnel; and
(iii) Onsite emergency facilities and services that facilitate the
use of available offsite services.
(7) Utility services. The design must provide for continued
operation of essential utility services.
(8) Inspection, testing, and maintenance. The design of items
relied on for safety must provide for adequate inspection, testing, and
maintenance, to ensure their availability and reliability to perform
their function when needed.
(9) Instrumentation and controls. The design must provide for
inclusion of instrumentation and control systems to monitor and control
the behavior of items relied on for safety.
(b) Design and layout. Facility and system design and facility
layout must be based on defense-in-depth practices. The design must
incorporate, to the extent practicable:
(1) Preference for the selection of engineered controls over
administrative controls to increase overall system reliability; and
(2) Features that enhance safety by reducing challenges to items
relied on for safety.

Sec. 40.84 Additional content of applications.

(a) In addition to the contents required by Sec. 40.31, each
license application must include a description of the applicant's
safety program established under Sec. 40.82.
(b) In any evaluation submitted under Sec. 40.31(j)(1)(i),
licensees and applicants must also show that, in the event of a
release, an acute chemical exposure from licensed material or hazardous
chemicals produced from licensed materials would not result in
irreversible or mild transient health effects to a member of the public
offsite. If such an evaluation is not submitted, licensees and
applicants must submit an emergency plan pursuant to Sec. 40.31(j)(3).
(c) The integrated safety analysis summary must be submitted with
the license or renewal application (and amendment application as
necessary), but will not be incorporated in the license. However,
changes to the integrated safety analysis summary are subject to the
Sec. 40.86 requirements. The integrated safety analysis summary must
contain:
(1) A general description of the site with emphasis on those
factors that could affect safety (i.e., meteorology, seismology);
(2) A general description of the facility with emphasis on those
areas that could affect safety, including an identification of the
controlled area boundaries;
(3) A description of each process (defined as a single reasonably
simple integrated unit operation within an overall production line)
analyzed in the integrated safety analysis in sufficient detail to
understand the theory of operation; and, for each process, the hazards
that were identified in the integrated safety analysis as specified in
Sec. 40.82(c)(1)(i) through (c)(1)(iii) and a general description of
the types of accident sequences considered for that process;
(4) Information that demonstrates the licensee's compliance with
the performance requirements of Sec. 40.81, including a description of
the management measures and, if applicable, the requirements of Sec.
40.83;
(5) A description of the team, qualifications, and the methods used
to perform the integrated safety analysis;
(6) A list briefly describing each item relied on for safety which
is identified as specified in Sec. 40.81(d) in sufficient detail to
understand their functions in relation to the performance requirements
of Sec. 40.81;
(7) A description of the proposed quantitative standards used to
assess the consequences to an individual from acute chemical exposure
to licensed material or chemicals produced from licensed materials
which are on-site, or expected to be on-site as described in Sec. Sec.
40.81(b)(4) and (c)(4);
(8) A descriptive list that identifies all items relied on for
safety that are the sole item preventing or mitigating an accident
sequence that exceeds the performance requirements of Sec. 40.81; and
(9) A description of the definitions of unlikely, highly unlikely,
and credible as used in the evaluations in the integrated safety
analysis.

[[Page 28356]]

Sec. 40.85 Additional requirements for approval of license
application.

(a) A license application from an applicant subject to the
requirements of this subpart will be approved if the Commission
determines that the applicant has complied with the license
requirements (subpart D) of this part and Sec. Sec. 40.80 through
40.85.
(b) Submittals by existing licensees in accordance with Sec.
40.82(c)(3)(i) will be approved if the Commission determines that:
(1) The integrated safety analysis approach is in accordance with
the requirements of Sec. Sec. 40.81, 40.82(c)(1), and 40.82(c)(2); and
(2) The schedule is in compliance with Sec. 40.82(c)(3)(ii).
(c) Integrated safety analysis summaries submitted by licensees
will be approved if the Commission determines that:
(1) The requirements of Sec. 40.84(b) are satisfied; and
(2) The performance requirements in Sec. Sec. 40.81(b), (c) and
(d) are satisfied, based on the information in the integrated safety
analysis summary, together with other information submitted to the NRC
or available to the NRC at the licensee's site.

Sec. 40.86 Facility changes and change process.

(a) The licensee must establish a configuration management system
to evaluate, implement, and track each change to the site, structures,
processes, systems, equipment, components, computer programs, and
activities of personnel. This system must be documented in written
procedures and must assure that the following are evaluated prior to
implementing any change:
(1) The technical basis for the change;
(2) Impact of the change on safety and health or control of
licensed material;
(3) Modifications to existing operating procedures including any
necessary training or retraining before operation;
(4) Authorization requirements for the change;
(5) For temporary changes, the approved duration (e.g., expiration
date) of the change; and
(6) The impacts or modifications to the integrated safety analysis,
integrated safety analysis summary, or other safety program
information, developed in accordance with Sec. 40.82.
(b) Any change to site, structures, processes, systems, equipment,
components, computer programs, and activities of personnel must be
evaluated by the licensee as specified in paragraph (a) of this
section, before the change is implemented. The evaluation of the change
must determine, before the change is implemented, if an amendment to
the license is required to be submitted in accordance with Sec. 40.44.
(c) The licensee may make changes to the site, structures,
processes, systems, equipment, components, computer programs, and
activities of personnel, without prior Commission approval, if the
change does not:
(1) Create new types of accident sequences that, unless mitigated
or prevented, would exceed the performance requirements of Sec. 40.81
and that have not previously been described in the integrated safety
analysis summary;
(2) Use new processes, technologies, or control systems for which
the licensee has no prior experience;
(3) Remove, without at least an equivalent replacement of the
safety function, an item relied on for safety that is listed in the
integrated safety analysis summary and is necessary for compliance with
the performance requirements of Sec. 40.81;
(4) Alter any item relied on for safety, listed in the integrated
safety analysis summary, that is the sole item preventing or mitigating
an accident sequence that exceeds the performance requirements of Sec.
40.81; or
(5) Violate the requirements of this section, or any license
condition, or order.
(d)(1) For changes that require pre-approval under this section,
the licensee must submit an amendment request to the NRC in accordance
with Sec. Sec. 40.44 and 40.84.
(2) For changes that do not require pre-approval under this
section, the licensee must submit to the NRC annually, within 30 days
after the end of the calendar year during which the changes occurred, a
brief summary of all changes to the records required by Sec.
40.82(a)(2).
(3) For all changes that affect the integrated safety analysis
summary, the licensee must submit to the NRC annually, within 30 days
after the end of the calendar year during which the changes occurred,
revised integrated safety analysis summary pages.
(e) If a change covered by this section is made, the affected on-
site documentation must be updated promptly.
(f) The licensee must maintain records of changes to its facility
carried out under this section. These records must include a written
evaluation that provides the bases for the determination that the
changes do not require prior Commission approval under paragraph (c) or
(d) of this section. These records must be maintained until termination
of the license.

Sec. 40.87 Renewal of licenses.

Applications for renewal of a license must be filed in accordance
with Sec. 2.109 of this chapter, and Sec. Sec. 40.43 and 40.85.
Information contained in previous applications, statements, or reports
filed with the Commission under the license may be incorporated by
reference, provided that these references are clear and specific.

Sec. 40.88 Additional reporting requirements.

Licensees who are required to conduct an integrated safety analysis
must comply with the following reporting requirements (except for
paragraphs (a)(1), (a)(2), and (b)(4) of this section), after they have
submitted an integrated safety analysis summary. Licensees must comply
with paragraphs (a)(1), (a)(2), and (b)(4) of this section after
[insert effective date of final rule]. Reports must be made by a
knowledgeable licensee representative and by any method that will
ensure compliance with the required time period for reporting.
Licensees must provide reasonable assurance that reliable communication
with the NRC Operations Center is available during events that trigger
these reporting requirements.
(a) One-hour reports. In addition to the events described in Sec.
40.60(a) that must be reported within 4 hours of discovery, the
following events must be reported to the NRC Operations Center within 1
hour of discovery, supplemented with the information described in
paragraph (d)(1) of this section as it becomes available, followed by a
written report within 60 days:
(1) An acute intake by an individual of 30 mg or greater of uranium
in a soluble form.
(2) An acute chemical exposure to an individual from licensed
material or hazardous chemicals produced from licensed material that
exceeds the quantitative standards established to satisfy the
requirements in Sec. 40.81(b)(4).
(3) An event or condition such that no items relied on for safety,
as documented in the integrated safety analysis summary, remain
available and reliable, in an accident sequence evaluated in the
integrated safety analysis, to perform their function in the context of
the performance requirements in Sec. Sec. 40.81(b) and (c).
(b) Twenty-four hour reports. In addition to the events described
in Sec. 40.60(b), the following events must also be reported to the
NRC Operations Center within 24 hours of discovery, supplemented with
the information

[[Page 28357]]

described in paragraph (d)(1) of this section as it becomes available,
followed by a written report within 60 days:
(1) Any event or condition that results in the facility being in a
state that was not analyzed, was improperly analyzed, or is different
from that analyzed in the integrated safety analysis, and which results
in failure to meet the performance requirements of Sec. 40.81.
(2) Loss or degradation of items relied on for safety that results
in failure to meet the performance requirement of Sec. 40.81.
(3) An acute chemical exposure to an individual from licensed
material or hazardous chemicals produced from licensed materials that
exceeds the quantitative standards that satisfy the requirements of
Sec. 40.81(c)(4).
(4) Any natural phenomenon or other external event, including fires
internal and external to the facility that has affected or may have
affected the intended safety function or availability or reliability of
one or more items relied on for safety.
(c) Concurrent reports. Any event or situation, related to the
health and safety of the public or onsite personnel, or protection of
the environment, for which a news release is planned or notification to
other government agencies has been or will be made, must be reported to
the NRC Operations Center concurrent to the news release or other
notification.
(d) Follow-up reports to the NRC Operations Center. (1) To the
extent that the information is available at the time of notification,
all reports called in to the NRC Operations Center must include:
(i) Caller's name, position title, and call-back telephone number;
(ii) Date, time, and exact location of the event;
(iii) Description of the event, including:
(A) Radiological or chemical hazards involved, including isotopes,
quantities, and chemical and physical form of any material released;
(B) Actual or potential health and safety consequences to the
workers, the public, and the environment, including relevant chemical
and radiation data for actual personnel exposures to radiation or
radioactive materials or hazardous chemicals produced from licensed
materials (e.g., level of radiation exposure, concentration of
chemicals, and duration of exposure);
(C) The sequence of occurrences leading to the event including
degradation or failure of structures, systems, equipment, components,
and activities of personnel relied on to prevent potential accidents or
mitigate their consequences; and
(D) Whether the remaining structures, systems, equipment,
components, and activities of personnel relied on to prevent potential
accidents or mitigate their consequences are available and reliable to
perform their functions;
(iv) External conditions affecting the event;
(v) Additional actions taken by the licensee in response to the
event;
(vi) Status of the event (e.g., whether the event is on-going or
was terminated);
(vii) Current and planned site status, including any declared
emergency class;
(viii) Notifications, related to the event, that were made or are
planned to any local, State, or other Federal agencies; and
(ix) Status of any press releases related to the event that were
made or are planned.
(2) Follow-up information in the reports called in to the NRC
Operations Center must be provided until all information required to be
reported is complete.
(e) Written reports. Written reports required by paragraphs (a) and
(b) of this section are subject to the following requirements:
(1) These written reports must be sent to the NRC's Document
Control Desk, using an appropriate method listed in Sec. 40.5(a), with
a copy to the appropriate NRC regional office listed in Appendix D to
part 20 of this chapter.
(2) The reports must include the following:
(i) Complete applicable information required by paragraph (d)(1) of
this section;
(ii) Probable cause of the event, including all factors that
contributed to the event and the manufacturer and model number (if
applicable) of any equipment that failed or malfunctioned;
(iii) Corrective actions taken or planned to prevent occurrence of
similar or identical events in the future and the results of any
evaluations or assessments; and
(iv) Whether the event was identified and evaluated in the
integrated safety analysis.

Sec. 40.89 Backfitting.

(a) Applicability. The requirements in this section apply with
respect to those facilities of licensees who are authorized to possess
2000 kilograms (4400 lb) or more of uranium hexafluoride, and are
applicable once such a licensee's ISA summary has been approved by the
NRC pursuant to Sec. 40.85.
(b) Definition of backfiting. Backfitting is defined as the
modification of, or addition to, systems, structures, or components of
a facility of a licensee subject to ISA requirements; or to the
procedures or organization required to operate such a facility; any of
which may result from a new or amended provision in the Commission
rules or the imposition of a regulatory staff position interpreting the
Commission rules that is either new or different from a previous NRC
staff position.
(c) Backfit analysis. (1) Except as provided in paragraph (c)(3) of
this section, the Commission shall require a systematic and documented
analysis for backfits which it seeks to impose.
(2) Except as provided in paragraph (c)(3) of this section, the
Commission shall require the backfitting of a facility only when it
determines, based on the analysis described in paragraph (d) of this
section, that there is a substantial increase in the overall protection
of the public health and safety or the common defense and security to
be derived from the backfit and that the direct and indirect costs of
implementation for that facility are justified in view of this
increased protection.
(3) The provisions of paragraphs (c)(1) and (c)(2) of this section
are inapplicable and, therefore, backfit analysis is not required and
the standards in paragraph (c)(2) of this section do not apply where
the Commission finds and declares, with appropriately documented
evaluation for its finding, any of the following:
(i) That a modification is necessary to bring a facility into
compliance with subpart H of this part;
(ii) That a modification is necessary to bring a facility into
compliance with a license or the rules or orders of the Commission, or
into conformance with written commitments by the licensee;
(iii) That regulatory action is necessary to ensure that the
facility either provides adequate protection to the health and safety
of the public, or is in accord with the common defense and security; or
(iv) That the regulatory action involves defining or redefining
what level of protection to the public health and safety or common
defense and security should be regarded as adequate.
(4) The Commission shall always require the backfitting of a
facility if it determines that the regulatory action is necessary to
ensure that the facility provides adequate protection to the health and
safety of the public and is in accord with the common defense and
security.
(5) The documented evaluation required by paragraph (c)(3) of this
section must include a statement of the objectives of and reasons for
the

[[Page 28358]]

modification and the basis for invoking the exception. If immediate
effective regulatory action is required, then the documented evaluation
may follow, rather than precede, the regulatory action.
(6) If there are two or more ways to achieve compliance with a
license or the rules or orders of the Commission, or with written
license commitments, or there are two or more ways to reach an adequate
level of protection, then ordinarily the licensee is free to choose the
way that best suits its purposes. However, should it be necessary or
appropriate for the Commission to prescribe a specific way to comply
with its requirements or to achieve adequate protection, then cost may
be a factor in selecting the way, provided that the objective of
compliance or adequate protection is met.
(d) Considerations to be addressed in backfit analysis. In reaching
the determination required by paragraph (c)(2) of this section, the
Commission will consider how the backfit should be scheduled in light
of other ongoing regulatory activities at the facility and, in
addition, will consider information available concerning any of the
following factors as may be appropriate and any other information
relevant and material to the proposed backfit:
(1) Statement of the specific objectives that the proposed backfit
is designed to achieve;
(2) General description of the activity that would be required by
the licensee in order to complete the backfit;
(3) Potential change in the risk to the public from the accidental
release of radioactive material and hazardous chemicals produced from
licensed material;
(4) Potential impact on facility employees from radiological
exposure or exposure to hazardous chemicals produced from licensed
material;
(5) Installation and continuing costs associated with the backfit,
including the cost of facility downtime;
(6) The potential safety impact of changes in facility or
operational complexity, including the relationship to proposed and
existing regulatory requirements;
(7) The estimated resource burden on the NRC associated with the
proposed backfit and the availability of such resources;
(8) The potential impact of differences in facility type, design,
or age on the relevancy and practicality of the proposed backfit; and
(9) Whether the proposed backfit is interim or final and, if
interim, the justification for imposing the proposed backfit on an
interim basis.
(e) Prohibition on withholding license amendment or ISA approval.
No license amendment or ISA approval will be withheld during the
pendency of backfit analyses required by the Commission's rules.
(f) Authority of the EDO. The Executive Director for Operations
shall be responsible for implementation of this section, and all
analyses required by this section shall be approved by the Executive
Director for Operations or his or her designee.

PART 150--EXEMPTIONS AND CONTINUED REGULATORY AUTHORITY IN
AGREEMENT STATES AND IN OFFSHORE WATERS UNDER SECTION 274

17. The authority citation for part 150 continues to read as
follows:

Authority: Sec. 161, 68 Stat. 948, as amended, sec. 274, 73
Stat. 688 (42 U.S.C. 2201, 2021); sec. 201, 88 Stat. 1242, as
amended (42 U.S.C. 5841); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504
note); Energy Policy Act of 2005, Pub. L. 109-58, 119 Stat. 594
(2005).
Sections 150.3, 150.15, 150.15a, 150.31, 150.32 also issued
under secs. 11e(2), 81, 68 Stat. 923, 935, as amended, secs. 83, 84,
92 Stat. 3033, 3039 (42 U.S.C. 2014e(2), 2111, 2113, 2114). Section
150.14 also issued under sec. 53, 68 Stat. 930, as amended (42
U.S.C. 2073).
Section 150.15 also issued under secs. 135, 141, Pub. L. 97-425,
96 Stat. 2232, 2241 (42 U.S.C. 10155, 10161). Section 150.17a also
issued under sec. 122, 68 Stat. 939 (42 U.S.C. 2152). Section 150.30
also issued under sec. 234, 83 Stat. 444 (42 U.S.C. 2282).

18. In Sec. 150.15, paragraph (a)(10) is added to read as follows:

Sec. 150.15 Persons not exempt.

(a) * * *
(10) Possession of 2000 kilograms (4400 lb) or more of uranium
hexafluoride.
* * * * *

Dated at Rockville, Maryland, this 6th day of May 2011.

For the Nuclear Regulatory Commission.
Annette Vietti-Cook,
Secretary of the Commission.
[FR Doc. 2011-11927 Filed 5-16-11; 8:45 am]
BILLING CODE 7590-01-P