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



[[Page 28336]]

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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.

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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: 
[email protected].
     Mail comments to: Secretary, U.S. Nuclear Regulatory 
Commission, Washington, DC 20555-0001, ATTN: Rulemakings and 
Adjudications Staff.
     E-mail comments to: [email protected]. 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: [email protected].
     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: [email protected].

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 [email protected]. 
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.

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    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 
[email protected]; (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 [email protected] 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 
[email protected]; (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