Domestic Licensing of Source Material-Amendments/Integrated Safety Analysis, 28336-28358 [2011-11927]

Agencies

• NUCLEAR REGULATORY COMMISSION

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



[[Page 28336]]

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

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

SUPPLEMENTARY INFORMATION:

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

I. Submitting Comments and Accessing Information

    Comments submitted in writing or in electronic form will be posted 
on the NRC Web site and on the Federal rulemaking Web site, https://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 https://www.nrc.gov/reading-rm/adams.html. From this page, the public can gain entry into ADAMS, 
which provides text and image files of NRC's public documents. If you 
do not have access to ADAMS or if there are problems in accessing the 
documents located in ADAMS, contact the NRC's PDR reference staff at 1-
800-397-4209, or 301-415-4737, or by e-mail to PDR.Resource@nrc.gov. 
The proposed rule and draft guidance document are available 
electronically under ADAMS Accession Numbers ML110890797 and 
ML102520022, respectively.
     Federal Rulemaking Web Site: Public comments and 
supporting materials related to the proposed rule and draft guidance 
document can be found at https://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.''

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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.

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    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