Nuclear Safety Management, 38982-38997 [2018-16863]
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38982
Proposed Rules
Federal Register
Vol. 83, No. 153
Wednesday, August 8, 2018
This section of the FEDERAL REGISTER
contains notices to the public of the proposed
issuance of rules and regulations. The
purpose of these notices is to give interested
persons an opportunity to participate in the
rule making prior to the adoption of the final
rules.
DEPARTMENT OF ENERGY
10 CFR Part 830
RIN 1992–AA57
Nuclear Safety Management
Office of Environment, Health,
Safety and Security, U.S. Department of
Energy.
ACTION: Notice of proposed rulemaking
and notice of public meetings.
AGENCY:
The Department of Energy
(DOE or the Department) publishes a
proposed rule to amend regulations
concerning nuclear safety management.
These regulations govern the conduct of
DOE contractors, DOE personnel, and
other persons conducting activities
(including providing items and services)
that affect, or may affect, the safety of
DOE nuclear facilities. The proposed
revisions reflect the experience gained
in the implementation of the regulations
over the past seventeen years, with
specific improvements to the process for
facility hazard categorization, the
unreviewed safety question process, and
the review and approval of safety
documentation. The proposed revisions
are intended to enhance operational
efficiency while maintaining robust
safety performance.
DATES: Public comment on this
proposed rule will be accepted until
October 9, 2018. For dates and more
information on the public meetings for
this proposed rulemaking, see
SUPPLEMENTARY INFORMATION.
ADDRESSES: You may submit comments,
identified by RIN 1992–AA57, by any of
the following methods:
1. Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
2. Email: Rulemaking.830@
hq.doe.gov. Include RIN 1992–AA57 in
the subject line of the email. Please
include the full body of your comments
in the text of the message or as an
attachment.
3. Mail: U.S. Department of Energy,
Office of Nuclear Safety, AU–30, 1000
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SUMMARY:
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Independence Avenue SW, Washington,
DC 20585.
Due to potential delays in DOE’s
receipt and processing of mail sent
through the U.S. Postal Service, we
encourage respondents to submit
comments electronically to ensure
timely receipt.
FOR FURTHER INFORMATION CONTACT: Mr.
Garrett Smith, U.S. Department of
Energy, Office of Nuclear Safety, AU–
30, 1000 Independence Avenue SW,
Washington, DC 20585; (301) 903–2996
or nuclearsafety@hq.doe.gov.
SUPPLEMENTARY INFORMATION: Public
meetings for this proposed rulemaking
will be held in:
1. Richland, WA at the HAMMER
Federal Training Facility, Building
6091, Room 10, 2890 Horn Rapids Road,
Richland, WA, on August 16th, 2018.
2. Albuquerque, NM at the
Albuquerque Marriott, Sandia Room,
2101 Louisiana Blvd. NE, Albuquerque,
NM, on September 6th, 2018.
3. Oak Ridge, TN at the Oak Ridge
Associated Universities, Pollard
Technology Conference Center
Auditorium, 210 Badger Avenue, Oak
Ridge, TN, on September 25th, 2018.
4. Aiken, SC at the University of
South Carolina—Aiken, Business and
Education Building, Room 124, 471
University Parkway, Aiken, SC, on
September 27th, 2018.
All public meetings will be held from
1 p.m. to 4:30 p.m. and from 6 p.m. to
8:30 p.m. local time. Interested persons
who wish to speak at the public meeting
should telephone the Office of Nuclear
Safety, (301) 903–2996, by 4:30 p.m.
Eastern Time on August 13th, 2018 for
Richland, WA, on August 31st, 2018 for
Albuquerque, NM, on September 18th,
2018 for Oak Ridge, TN, and on
September 20th, 2018 for Aiken, SC.
Each presentation is limited to 20
minutes.
I. Introduction and Background
A. Introduction
B. Procedural History of the Rule
II. Discussion of Proposed Rule
A. Discussion of Key Proposed Changes
B. Proposed Changes in Order of
Appearance
III. Public Comment Procedures
A. Written Comments
B. Public Meetings
IV. Regulatory Review
A. Review Under Executive Order 12866
B. Review Under Executive Orders 13771
and 13777
C. Regulatory Flexibility Act
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D. Paperwork Reduction Act
E. National Environmental Policy Act
F. Unfunded Mandates Reform Act of 1995
G. Treasury and General Government
Appropriations Act, 1999
H. Executive Order 13132
I. Executive Order 12988
J. Treasury and General Government
Appropriations Act, 2001
K. Executive Order 13211
V. Approval of the Office of the Secretary
I. Introduction and Background
A. Introduction
Pursuant to the Atomic Energy Act of
1954, as amended (the AEA), the
Department of Energy (DOE or the
Department) owns and leases nuclear
and non-nuclear facilities at various
locations in the United States. These
facilities are operated either by DOE or
by contractors with DOE oversight.
Activities at these facilities include, but
are not limited to: Research, testing,
production, disassembly, or transporting
nuclear materials. DOE regulations
governing nuclear safety at these
facilities are set forth in the Nuclear
Safety Management rule (10 CFR part
830). The regulations were issued in
response to external assessments from
the National Academy of Sciences
(NAS), the enactment of the PriceAnderson Amendments Act of 1988
(PAAA), and DOE efforts to improve
safety at DOE nuclear facilities. Aspects
of 10 CFR part 830 were finalized and
issued from 1994 to 2001, covering core
safety requirements for quality
assurance and facility safety basis. Over
the past 17 years, DOE has gained
considerable experience in the
implementation of 10 CFR part 830, and
is proposing to modify the requirements
to incorporate that experience and help
ensure more effective safety
performance.
B. Procedural History of the Rule
On December 9, 1991, DOE published
Procedural Rules for DOE Nuclear
Activities (56 FR 64290) and a Notice of
Proposed Rulemaking and Public
Hearing (1991 Notice, 56 FR 64316) to
add Parts 820 and 830 to Title 10 of the
Code of Federal Regulation (CFR).1 Title
1 The Department proposed 10 CFR part 820 (Part
820), Procedural Rules for DOE Nuclear Activities,
to establish the procedural requirements for
enforcement activities in accordance with PAAA.
On August 17, 1993, the Department issued the
Procedural Regulations for DOE Nuclear Activities
in final form as 10 CFR part 820 (58 FR 43680). Part
820 establishes the procedures for DOE enforcement
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10 CFR part 830 was proposed to
establish safety management
requirements for DOE nuclear facilities.
DOE issued, as final, the sections of 10
CFR part 830 related to the initial
provisions (§§ 830.1–830.7) and Subpart
A—General Provisions, (§§ 830.100–
830.120) on April 5, 1994 (1994 Notice,
59 FR 15843).
The Department issued a Notice of
Limited Reopening of the Comment
Periods for the remaining topics to be
addressed in 10 CFR part 830 on August
31, 1995, and for a second, unrelated,
rule (Reopening Notice, 60 FR 45381).
On October 10, 2000, the Department
published an Interim Final Rule and
Opportunity for Public Comment (65 FR
60291) which amended the nuclear
safety regulations to (1) establish and
maintain safety bases for Hazard
Category 1, 2, and 3 DOE nuclear
facilities and perform work in
accordance with safety bases, and (2)
clarify that the quality assurance work
process requirements apply to standards
and controls adopted to meet regulatory
or contract requirements that may affect
nuclear safety (Interim Final Rule). The
Interim Final Rule was also issued to
provide further opportunity for public
comment on the rule.
Following the public comment
period, the Department issued a Final
Rule on January 10, 2001 (66 FR 1810).
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II. Discussion of Proposed Rule
A. Discussion of Key Proposed Changes
1. DOE Standard 1027—Section
830.202 of the regulations requires that
DOE nuclear facilities be categorized
consistent with DOE–STD–1027–92
(‘‘Hazard Categorization and Accident
Analysis Techniques for compliance
with DOE Order 5480.23, Nuclear Safety
Analysis Reports,’’ Change Notice 1,
September 1997). The Department
continues to believe that the
methodology in DOE–STD–1027–92 Ch
1 is sufficient and supports the
categorization of DOE nuclear facilities.
In 2001, when Subpart B of 10 CFR part
830 was issued, not every Hazard
Category 1, 2, and 3 DOE nuclear facility
was categorized using a standardized
methodology, and therefore consistent
application of the cited reference,
without change, was appropriate.
DOE now proposes, after two decades
of experience in facility categorization
using DOE–STD–1027–92, Ch 1, to
amend § 830.202(b)(3) by adding ‘‘or
successor document’’. This change
would allow the Department to revise
the standard to include up-to-date
actions and for issuing civil and criminal penalties
for contractor, subcontractor, and supplier
violations of DOE nuclear safety requirements.
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research, data, and DOE experience with
implementation. This would be
consistent with DOE’s practice to
periodically evaluate and revise DOE
Technical Standards and would follow
the development, review, and approval
process described in DOE Order 252.1A,
Technical Standards Program. The
Technical Standards Program process
requires concurrence from all affected
Departmental elements prior to issuance
of any standard.
DOE also proposes to amend Section
C, Scope, of Appendix A to remove the
reference to the specific version of
DOE–STD–1027, for consistency with
the revision in § 830.202. DOE would
also remove Table 1 of Appendix A and
replace that table with a definition for
Hazard Category 1, 2, and 3 DOE
nuclear facilities in § 830.3 that
references DOE–STD–1027–92 or
successor document. The removal of
Table 1 would allow successor revisions
to more clearly link the determination of
Hazard Category 1, 2, 3, and below
hazard category 3 to the methodology in
the Standard. The concept that Hazard
Category 1 will have higher potential
consequences and Hazard Category 3
will have lower potential consequences
will be maintained throughout all
successor documents of DOE–STD–
1027.
2. Unreviewed Safety Question (USQ)
Process—A situation or potential
situation outside the bounds of the
current safety analysis for a Hazard
Category 1, 2, or 3 nuclear facility (as
documented in its approved safety
analysis) constitutes an Unreviewed
Safety Question under the current
regulations. Section 830.203 allows
contractors to make changes to the
facility, to change site or facility
procedures, and to conduct tests and/or
experiments without prior DOE
approval when these activities do not
involve an Unreviewed Safety Question
and do not require any change to
Technical Safety Requirements.
The proposed change to Appendix A
to Subpart B of 10 CFR part 830—
General Statement of Safety Basis
Policy, H, Unreviewed Safety Questions,
would add the sentence, ‘‘The
contractor is allowed to make editorial
and format changes to its USQ
procedure while maintaining DOE
approval.’’ This proposal would focus
the requirement to obtain DOE’s
approval on changes with the potential
to impact on the safety basis of the
facility.
DOE also proposes to modify § 830.3,
Definitions, by changing the definition
for Unreviewed Safety Question (USQ).
The current definition includes four
situations that define a USQ: (1) The
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probability of the occurrence or the
consequences of an accident or the
malfunction of equipment important to
safety previously evaluated in the
documented safety analysis (DSA) could
be increased; (2) The possibility of an
accident or malfunction of a different
type than any evaluated previously in
the documented safety analysis could be
created; or (3) A margin of safety could
be reduced; or (4) The documented
safety analysis may not be bounding or
may be otherwise inadequate. As
explained in the following paragraphs,
the proposed definition would remove
the third situation: ‘‘A margin of safety
could be reduced’’.
The current set of four situations that
define an USQ in 10 CFR 830.3 reflected
standard nuclear industry practice and
was an adaptation of 10 CFR 50.59,
changes, tests and experiments, used by
the United States Nuclear Regulatory
Commission (NRC). The NRC, in 1968,
added to § 50.59 the concept of ‘‘margin
of safety as defined in the basis for any
technical specification is reduced.’’ In
issuing 10 CFR part 830, DOE modified
this question to simply read ‘‘A margin
of safety could be reduced’’. In addition
to adapting the NRC process, DOE
included the situation of ‘‘(4) The
documented safety analysis may not be
bounding or may otherwise be
inadequate.’’
The NRC, after 30 years of experience
implementing § 50.59, issued an
October 21, 1998, Notice of Proposed
Rulemaking to change the criteria
associated with margin of safety,
explaining that ‘‘the phrases ‘margin of
safety’ and ‘as defined in the basis for
any technical specification’ in the third
criterion have been the subject of
differing interpretations because the
rule does not define what constitutes a
margin of safety or a basis for any
technical specification in the context of
§§ 50.59 and 72.48. In addition, some
have questioned the need for the third
criterion on ‘margin of safety.’ ’’ The
third criterion refers to the existence of
two prior questions associated with
creation, consequences, and likelihood
of accidents and equipment
malfunction. The revision to 10 CFR
part 50 removing the term ‘‘margin of
safety’’ from 10 CFR 50.59 was issued as
a final rule on October 4, 1999.
DOE’s experience with the margin of
safety criteria is similar to that
expressed by the NRC in its rulemaking,
specifically, that the other existing
criteria provide sufficient guidance to
identify facility and safety basis changes
that warrant DOE approval. Feedback
from periodic surveys considering a
broad-range of USQ determinations
indicated that the ‘‘margin of safety’’
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criterion has not provided benefit
independent of the criteria DOE is
retaining in the definition of the USQ
process. In addition, stakeholder
feedback noted that the ‘‘margin of
safety’’ criterion was subjectively
interpreted and often diverted safety
resources without a corresponding
safety benefit. Therefore, the proposed
removal of the criterion related to
‘‘margin of safety’’ would enhance DOE
and contractor operational effectiveness,
without reducing the level of safety
provided by the current practice. The
current practice allows contractors to
conduct certain specified activities
without prior DOE approval, when these
activities do not cause an Unreviewed
Safety Question (and when they do not
require Technical Safety Requirements
changes).2
3. DOE Approval of Annual DSA
Updates—As stated above, DOE
currently requires the contractor, in
§ 830.203, Unreviewed Safety Question
process, to obtain DOE approval prior to
taking any action determined to involve
a USQ. Additionally, in § 830.202 Safety
basis, DOE requires the contractor to
annually submit to DOE either the
updated DSA for approval or a letter
stating that there have been no changes
in the DSA since the prior submission.
This effectively requires the contractor
to submit changes to the DSA for DOE
approval twice. Currently, DOE
provides implementation guidance for
this approval process in DOE–STD–
1104–2016, Review and Approval of
Nuclear Facility Safety Basis and Safety
Design Basis Documents, Section 7.1.2,
Review of Safety Basis Changes and
DSA Annual Updates. The guidance
states that ‘‘Review and approval of
revisions and annual updates are a
matter of endorsing the incorporation of
changes in the safety basis since the last
approval rather than performing a new
assessment of the previously approved
safety basis documents.’’ While the
guidance is clear in the intent to drive
focus of DOE’s approval to the change
identified in the USQ process, the
regulations’ additional requirement for a
second approval has led to considerable
implementation challenges, and
unnecessary review iterations without
providing additional safety benefit.
2 DOE’s implementation guidance associated with
these criteria is DOE G 424.1–1B Chg 2,
Implementation Guide for Use in Addressing
Unreviewed Safety Question Requirements. Based
on the four criteria defining a situation involving
a USQ in 10 CFR part 830, DOE G 424.1–1B Chg
2 contains seven questions. The last question
related to the concept of the margin of safety. If
DOE adopts this proposal in a final rule, DOE
would also conduct a process to consider removal
of the question from the DOE Guide.
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Therefore, DOE is proposing to
change the requirement in § 830.202,
Safety basis, to require the current DSA
be provided to DOE annually, but not to
require DOE approval at that time.
Additional guidance would also be
included in Appendix A to Subpart B of
10 CFR part 830—General Statement of
Safety Basis Policy, F, Documented
Safety Analysis, to make clear that
DOE’s review and approval of the safety
analysis is intended to be focused on
changes submitted through the USQ
process, but may require DOE approval
if DOE has reason to believe a portion
of the safety basis has substantially
changed. DOE would continue to have
the authority to review the safety basis
at any time. DOE would maintain the
ability to direct the contractor to
incorporate in the safety basis any
changes, conditions, or hazard controls.
4. Definition and Application of New
Facilities, Major Modification,
Preliminary Documented Safety
Analysis, and Existing Facilities—The
current definitions of a New DOE
nuclear facility, Major Modification,
Preliminary documented safety
analysis, and Existing DOE nuclear
facility (and applications of those
definitions within the rule) reference
specific dates related to the issuance of
the rule and the need to bring DOE
nuclear facilities into the regulatory
framework. DOE is proposing to change
the definitions to clearly recognize that
all current DOE nuclear facilities are
already within this regulatory
framework and that new DOE nuclear
facilities would be those that are in
design or under construction that do not
yet have a DOE approved safety basis.
Additionally, the specific definition of
an existing DOE nuclear facility is being
proposed to be deleted. DOE proposes
instead to rely upon a new definition of
Hazard Category 1, 2, and 3 DOE
nuclear facilities and the specific
endpoint of a DOE approved safety basis
to delineate between a new facility and
an existing facility.
DOE also proposes to change the
definition of a Major modification to
remove the completion date of the
facility. The definition would rely upon
a criteria of a substantial change to the
existing safety basis for the facility. This
would link the meaning of ‘‘Major
modification’’ to changes to existing
Hazard Category 1, 2, or 3 nuclear
facilities via the existence of a safety
basis for the facility. Furthermore,
additional clarity is proposed within 10
CFR part 830, subpart B, to highlight
that the concept of ‘‘Major
modification’’ would only apply to
existing Hazard Category 1, 2, or 3 DOE
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nuclear facilities (i.e., nuclear facilities
with an approved safety basis).
DOE proposes to change the
definition of Preliminary documented
safety analysis to maintain consistency
with other proposed changes to the
definitions related to nuclear facilities.
B. Proposed Changes in Order of
Appearance
The specific proposed changes to 10
CFR part 830 are summarized below in
the order in which they appear:
1. In proposed § 830.3 ‘‘Definitions,’’
the current definition for Existing DOE
nuclear facility would be deleted, a
definition for Hazard Category 1, 2, and
3 DOE nuclear facilities has been
proposed, and there would be a
modification of the current definition of
New Hazard Category 1, 2, and 3 DOE
nuclear facility. These changes are
designed to improve the delineation
between new and existing facilities. The
definition for Major modification would
be changed to remove the effective date
associated with the original issuance of
the rule. The definition for Preliminary
documented safety analysis would be
changed to better reflect the intent of
preliminary documented safety analysis
being associated with Hazard Category
1, 2, or 3 DOE nuclear facilities rather
than all DOE nuclear facilities. The
definition for Safety management
system would be changed to include the
specific title of 48 CFR 970.5223–1,
Integration of environment, safety, and
health into work planning and
execution. The definition for
Unreviewed Safety Question (USQ)
would be changed by adding ‘‘or’’ to the
end of (2), deleting ‘‘(3) A margin of
safety could be reduced; or’’, and
renumbering (4) as (3).
2. In proposed § 830.201
‘‘Performance of Work,’’ current
§ 830.201 would be changed by adding
‘‘DOE-approved’’ to modify safety basis
to maintain consistency with § 830.207,
DOE approval of safety basis.
3. Proposed § 830.202(b)(3) would be
changed to add ‘‘or successor
document’’ to modify DOE–STD–1027–
92 (‘‘Hazard Categorization and
Accident Analysis Techniques for
compliance with DOE Order 5480.23,
Nuclear Safety Analysis Reports,’’
Change Notice 1, September 1997). This
proposed change would allow DOE to
modify the methodology used to
perform hazard categorization
consistent with DOE’s policy of
maintaining technical standards to
reflect updated knowledge and
methods. Current § 830.202(c)(2) would
be changed to read, ‘‘(2) Annually
provide DOE the current documented
safety analysis or a letter stating that
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there have been no changes in the
documented safety analysis since the
prior submittal; and’’. These proposed
changes reflect the removal of the
requirement for DOE to annually
approve the documented safety analysis,
and are intended to focus DOE’s
approval on the existing requirement to
approve changes through the USQ
process.
4. In proposed § 830.203 ‘‘Unreviewed
safety question process,’’ current
§ 830.203(a) would be changed by
adding ‘‘DOE-approved’’ as a modifier
to USQ, and by changing the word
‘‘process’’ to ‘‘procedure’’. These
proposed changes are to clarify the
connection between references to the
DOE-approved procedure in proposed
§ 830.203(a), § 830.203(b), and
§ 830.203(c). Current § 830.203(b) would
be deleted, since DOE no longer has
existing facilities operating outside of 10
CFR part 830. In the current
§ 830.203(c), which is proposed to be
redesignated as § 830.203(b), the word
‘‘new’’ has been proposed to be moved
to match a proposed change in the
definition of New Hazard Category 1, 2,
and 3 nuclear facility, and ‘‘207(d)’’
would be changed to ‘‘207(a)’’ to reflect
changes to § 830.207. Current
§ 830.203(d) would be redesignated as
§ 830.203(c). Current § 830.203(e) would
be redesignated as § 830.203(d). Current
§ 830.203(f) would be redesignated as
§ 830.203(e), ‘‘submit’’ would be
replaced by ‘‘provide’’, and
‘‘submissions’’ would be replaced by
‘‘submittal’’ to better reflect that the
document is being given to DOE for
review, but not for approval. Current
§ 830.203(g) would be redesignated as
§ 830.203(f), and the text would be
changed to read ‘‘initiated to meet
paragraph (f)(1) of this section’’
consistent with citation changes in this
section.
5. In proposed § 830.204
‘‘Documented safety analysis,’’ current
§ 830.204(a) would be updated by
changing ‘‘Table 2’’ to ‘‘Table 1’’ to
reflect the deletion of Table 1 and renumbering of subsequent tables.
6. In proposed § 830.206 ‘‘Preliminary
documented safety analysis,’’ current
§ 830.206 would be changed to read
‘‘Prior to construction of a new Hazard
Category 1, 2, or 3 DOE nuclear facility
or a major modification to an existing
Hazard Category 1, 2, or 3 DOE nuclear
facility, the contractor responsible for
the design and construction of the new
facility or major modification must:’’ To
reflect changes to the definitions in
§ 830.3. Current § 830.206(b)(1) would
be changed to add, ‘‘, or successor
document’’ as a modifier to ‘‘DOE Order
420.1, Facility Safety’’ to reflect the
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ongoing updates to the current version
of the DOE order.
7. In proposed § 830.207 ‘‘DOE
approval of safety basis,’’ current
§ 830.207(a) would be deleted, as DOE
no longer has existing Hazard Category
1, 2, or 3 facilities operated outside of
10 CFR part 830. Current § 830.207(b)
would be changed by adding ‘‘updated
or amended’’ to modify ‘‘safety basis’’,
moving the word ‘‘existing’’ to before
the phrase ‘‘Hazard Category 1, 2, or 3
DOE nuclear facility’’ to better match
the revised definition, and by deleting
‘‘in effect on October 10, 2000, or as
approved by DOE at a later date’’ to
reflect that all Hazard Category 1, 2, or
3 DOE nuclear facilities already operate
within 10 CFR part 830. Current
§ 830.207(c) would be deleted, as DOE
no longer has existing Hazard Category
1, 2, or 3 facilities operated outside of
10 CFR part 830. Current § 830.207(d)
would be redesignated as § 830.207(a)
and updated to reflect the changes in
definitions in § 830.3. As a result, the
proposed § 830.207(a) would now read
as: ‘‘With respect to a new Hazard
Category 1, 2, or 3 DOE nuclear facility
or a major modification to an existing
Hazard Category 1, 2, or 3 DOE nuclear
facility, a contractor may not begin
operation of the facility or modification
prior to the issuance of a safety
evaluation report in which DOE
approves the safety basis for the facility
or modification.’’
8. In proposed Appendix A to Subpart
B to 10 CFR part 830—General
Statement of Safety Basis Policy current
‘‘A. Introduction’’ would be modified by
replacing a reference to an outdated
DOE Policy with a specific statement
that reflects current DOE policy and
would now read as follows, ‘‘This
Appendix does not create any new
requirements and should be used
consistently with DOE’s policy that
work be conducted safely and efficiently
and in a manner that ensures protection
of workers, the public, and the
environment.’’
9. In proposed Appendix A to Subpart
B to 10 CFR part 830—General
Statement of Safety Basis Policy current
‘‘C. Scope, 1.’’ would be changed by
replacing the reference to ‘‘DOE–STD–
1027–92 Change Notice 1, September
1997’’ with a general reference to DOE–
STD–1027 to reflect the proposed
change to allow successor versions of
DOE–STD–1027 to be used, the
reference to ‘‘Table 1’’ would be deleted
to reflect the proposed deletion of Table
1. The proposed sentences now would
read, ‘‘A contractor must establish and
maintain a safety basis for a Hazard
Category 1, 2, or 3 DOE nuclear facility
because these facilities have the
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potential for significant radiological
consequences. DOE–STD–1027 sets
forth the methodology for categorizing a
DOE nuclear facility based on the
inventory of radioactive materials.’’
Current ‘‘C. Scope, 2.’’ Would be
changed to delete the parenthetical
reference to ‘‘including radiological
facilities’’, and by adding ‘‘DOE’’ to the
reference to Hazard Category 1, 2, and
3 nuclear facilities to match changes to
definitions within § 830.3. Current ‘‘C.
Scope’’ Table 1 is proposed for deletion
for consistency with the proposal to
allow use of subsequent versions of
DOE–STD–1027, since Table 1
references the specific content of DOE–
STD–1027–92, Change Notice 1,
September 1997.
10. In proposed Appendix A to
Subpart B to 10 CFR part 830—General
Statement of Safety Basis Policy, current
‘‘E. Enforcement of Safety Basis
Requirements, 4.’’ would be changed by
deleting the word ‘‘however’’ to
improve clarity.
11. In proposed Appendix A to
Subpart B to 10 CFR part 830—General
Statement of Safety Basis Policy current
‘‘F. Documented Safety Analysis, 3.’’
would be changed by adding ‘‘as: (1)
part of the initial submittal; (2) when
revisions are submitted as part of a
positive USQ or major modification; (3)
if DOE has reason to believe a portion
of the safety basis to be inadequate, or;
(4) if DOE has reason to believe a
portion of the safety basis has
substantially changed. DOE will review
the DSA’’ to better define when and
why DOE would review a DSA. This
change is proposed to be consistent with
proposed changes to DOE’s requirement
to annually approve the DSA. Current
‘‘F. Documented Safety Analysis, 3.’’
would also be changed by adding ‘‘in
the Safety Evaluation Report’’ to the end
of the last sentence in that section,
which currently reads, ‘‘A documented
safety analysis must contain any
conditions or changes required by
DOE.’’ This change is proposed to
clarify how DOE directs conditions and
changes required by DOE. Additionally,
Current ‘‘F. Documented Safety
Analysis, 3.’’ would be changed by
adding the following sentences,
‘‘Generally, DOE’s review of the annual
submittal may be limited to ensuring
that the results of USQs have been
adequately incorporated into the DSA. If
additional changes are proposed by the
contractor and included in the annual
update that have not been previously
approved by DOE or have not been
evaluated as a part of the USQ process,
DOE must review and approve these
changes. DOE has the authority to
review the safety basis at any time.’’
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This proposed change is in support of
focusing DOE’s approval of changes in
the DSA to the incorporation of USQ’s
or as DOE determines are necessary to
maintain safe operations, rather than the
previous annual process. Current ‘‘F.
Documented Safety Analysis, 4.’’ would
be changed by renumbering the
reference to ‘‘Table 2’’ to ‘‘Table 1’’ to
reflect the deletion of Table 1. Current
‘‘F. Documented Safety Analysis’’
would be changed by changing the title
of ‘‘Table 2’’ to ‘‘Table 1’’ to reflect the
deletion of Table 1. Current ‘‘F.
Documented Safety Analysis, 5.’’ would
be changed by renumbering the
reference to ‘‘Table 2’’ to ‘‘Table 1’’ to
reflect the deletion of Table 1, by
changing the reference to the definition
of nuclear facility to re-state the existing
definition within § 830.3 instead of
paraphrasing the definition, by
renumbering the reference to ‘‘Table 3’’
to ‘‘Table 2’’ to reflect the deletion of
Table 1, and by replacing ‘‘specific
nuclear facilities’’ with ‘‘terms’’ in
reference to the content within Table 1.
Current ‘‘F. Documented Safety
Analysis’’ would be changed by
renumbering the title of ‘‘Table 3’’ to
‘‘Table 2’’ to reflect the proposed
deletion of Table 1 and changing the
reference to ‘‘Table 2’’ to ‘‘Table 1’’ to
reflect the proposed deletion of Table 1.
Current ‘‘F. Documented Safety
Analysis, 6.’’ would be changed to
delete the phrase ‘‘If construction begins
after December 11, 2000’’ and by adding
‘‘or successor document’’ as a modifier
to ‘‘DOE Order 420.1, Facility Safety’’ to
reflect the ongoing updates to the
current version of the DOE order.
12. In proposed Appendix A to
Subpart B to 10 CFR part 830—General
Statement of Safety Basis Policy current
‘‘G. Hazard Controls, 2.’’ would be
changed to add ‘‘or successor
document’’ as a modifier to ‘‘DOE Order
420.1, Facility Safety’’ to reflect the
ongoing updates to the current version
of the DOE order. Current ‘‘G. Hazard
Controls, 4.’’ would be changed to
update the reference to DOE Guide
423.1–1B and by adding, ‘‘or successor
document’’ to reflect the ongoing
updates to the current version of the
DOE guide. Current ‘‘G. Hazard
Controls, 4.’’ would be changed by
changing the reference to ‘‘Table 4’’ to
‘‘Table 3’’ to reflect the proposed
deletion of Table 1. Current ‘‘G. Hazard
Controls’’ would be changed by
changing the title of the table from
‘‘Table 4’’ to ‘‘Table 3’’ to reflect the
proposed deletion of Table 1.
13. In proposed Appendix A to
Subpart B to 10 CFR part 830—General
Statement of Safety Basis Policy current
‘‘H. Unreviewed Safety Questions, 3.’’
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Would be changed to update the
reference to DOE Guide 424.1–1B Chg 2,
to update the title of the referenced
guide to ‘‘Implementation Guide for Use
in Addressing Unreviewed Safety
Question Requirements,’’ to add ‘‘or
successor document’’ to reflect the
ongoing updates to the current version
of the DOE guide, and by adding the
sentence, ‘‘The contractor is allowed to
make editorial and format changes to its
USQ procedure while maintaining DOE
approval.’’ The additional sentence
wold be provided to better delineate
those aspects of the USQ process on
which DOE approval focuses.
14. Throughout 10 CFR part 830, the
term ‘‘Hazard Category’’ would be
capitalized to improve consistency with
the usage within the DOE regulatory
structure.
III. Public Comment Procedures
A. Written Comments
Interested persons are invited to
participate in this proceeding by
submitting data, views, or arguments.
Written comments should be submitted
to the address, and in the form,
indicated in the ADDRESSES section of
this notice of proposed rulemaking. To
help DOE review the comments,
interested persons are asked to refer to
specific proposed rule provisions, if
possible.
If you submit information that you
believe to be exempt by law from public
disclosure, you should submit one
complete copy, as well as one copy from
which the information claimed to be
exempt by law from public disclosure
has been deleted. DOE is responsible for
the final determination with regard to
disclosure or nondisclosure of the
information and for treating it
accordingly under the DOE Freedom of
Information regulations at 10 CFR
1004.11.
B. Public Meetings
Public meetings will be held at the
times, dates, and places indicated at the
start of the SUPPLEMENTARY INFORMATION
section of this notice of proposed
rulemaking. Any person who is
interested in making an oral
presentation should make a phone
request to the person and telephone
number in the SUPPLEMENTARY
INFORMATION section by 4:30 p.m. on the
date specified for making such requests.
The person should provide a daytime
phone number where he or she can be
reached. Each oral presentation will be
limited to 20 minutes. Persons making
an oral presentation are requested to
bring 3 copies of their prepared
statement to the meeting and submit
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them to the registration desk prior to the
meeting.
IV. Regulatory Review
A. Review Under Executive Order 12866
This notice of proposed rulemaking
has been determined not to be a
significant regulatory action under
Executive Order 12866, ‘‘Regulatory
Planning and Review,’’ 58 FR 51735
(Oct. 4, 1993). Accordingly, this notice
of proposed rulemaking was not subject
to review by the Office of Information
and Regulatory Affairs of the Office of
Management and Budget.
B. Review Under Executive Orders
13771 and 13777
On January 30, 2017, the President
issued Executive Order 13771,
‘‘Reducing Regulation and Controlling
Regulatory Costs.’’ That Order stated the
policy of the executive branch is to be
prudent and financially responsible in
the expenditure of funds, from both
public and private sources. The Order
stated it is essential to manage the costs
associated with the governmental
imposition of private expenditures
required to comply with Federal
regulations. This proposed rule is
expected to be an E.O. 13771
deregulatory action.
Additionally, on February 24, 2017,
the President issued Executive Order
13777, ‘‘Enforcing the Regulatory
Reform Agenda.’’ The Order required
the head of each agency designate an
agency official as its Regulatory Reform
Officer (RRO). Each RRO oversees the
implementation of regulatory reform
initiatives and policies to ensure that
agencies effectively carry out regulatory
reforms, consistent with applicable law.
Further, E.O. 13777 requires the
establishment of a regulatory task force
at each agency. The regulatory task force
is required to make recommendations to
the agency head regarding the repeal,
replacement, or modification of existing
regulations, consistent with applicable
law. At a minimum, each regulatory
reform task force must attempt to
identify regulations that:
(i) Eliminate jobs, or inhibit job
creation;
(ii) Are outdated, unnecessary, or
ineffective;
(iii) Impose costs that exceed benefits;
(iv) Create a serious inconsistency or
otherwise interfere with regulatory
reform initiatives and policies;
(v) Are inconsistent with the
requirements of Information Quality
Act, or the guidance issued pursuant to
that Act, in particular those regulations
that rely in whole or in part on data,
information, or methods that are not
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publicly available or that are
insufficiently transparent to meet the
standard for reproducibility; or
(vi) Derive from or implement
Executive Orders or other Presidential
directives that have been subsequently
rescinded or substantially modified.
DOE concludes that this final rule is
consistent with the directives set forth
in these executive orders. This
provisions in this proposed rule are
intended, as described in section II, to
enhance operational efficiency while
maintaining robust safety performance
at DOE nuclear facilities.
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C. Regulatory Flexibility Act
The Regulatory Flexibility Act (5
U.S.C. 601 et seq.) requires preparation
of an initial regulatory flexibility
analysis for any rule that by law must
be proposed for public comment, unless
the agency certifies that the rule, if
promulgated, will not have a significant
economic impact on a substantial
number of small entities. As required by
Executive Order 13272, ‘‘Proper
Consideration of Small Entities in
Agency Rulemaking,’’ 67 FR 53461
(Aug. 16, 2002), DOE published
procedures and policies on February 19,
2003, to ensure that the potential
impacts of its rules on small entities are
properly considered during the
rulemaking process. 68 FR 7990. DOE
has made its procedures and policies
available on the Office of the General
Counsel’s website (https://energy.gov/gc/
office-general-counsel).
DOE has reviewed this proposed rule
under the provisions of the Regulatory
Flexibility Act and the procedures and
policies published on February 19,
2003. The proposed rule would
incorporate the experience of more than
a decade of implementation to improve
the effectiveness of the DOE nuclear
safety regulatory framework while
maintaining safety performance.
Requirements that are considered
duplicative or of little value have been
proposed to be removed. DOE is
proposing four key changes in this
proposed rule, as described in II.
Discussion of Proposed Rule, A.
Discussion of Key Proposed Changes.
The changes in this proposed rule are
all expected to reduce burden on
affected DOE contractors. On this basis,
DOE certifies that this proposed rule
would not have a significant economic
impact on a substantial number of small
entities. Accordingly, DOE has not
prepared a regulatory flexibility analysis
for this rulemaking. DOE’s certification
and supporting statement of factual
basis will be provided to the Chief
Counsel for Advocacy of the Small
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Business Administration pursuant to 5
U.S.C. 605(b).
D. Paperwork Reduction Act
The information collection necessary
to administer DOE’s nuclear safety
program under 10 CFR part 830 is
subject to OMB approval under the
Paperwork Reduction Act, 44 U.S.C.
3501 et seq. The information collection
provisions of this rule are not
substantially different from those
contained in DOE contracts with DOE
prime contractors covered by this rule
and were previously approved by the
Office of Management and Budget
(OMB) and under OMB Control No.
1910–0300. Public reporting burden for
the certification is estimated to average
1.91 hours per response, including the
time for reviewing instructions,
searching existing data sources,
gathering and maintaining the data
needed, and completing and reviewing
the collection of information.
Notwithstanding any other provision
of the law, no person is required to
respond to, nor shall any person be
subject to a penalty for failure to comply
with, a collection of information subject
to the requirements of the PRA, unless
that collection of information displays a
currently valid OMB Control Number.
E. National Environmental Policy Act
DOE has determined that this
proposed rule is covered under the
Categorical Exclusion in DOE’s National
Environmental Policy Act regulations at
paragraph A.5 of Appendix A to Subpart
D, 10 CFR part 1021, which applies to
rulemaking that interprets or amends an
existing rule or regulation without
changing the environmental effect of the
rule or regulation that is being amended.
The proposed rule would amend DOE’s
regulations by removing duplicative
approval requirements, updating
definitions, and increasing the
efficiency of internal processes. These
proposed amendments are primarily
procedural and would not change the
environmental effect of 10 CFR part 830.
Accordingly, neither an environmental
assessment nor an environmental
impact statement is required.
F. Unfunded Mandates Reform Act of
1995
Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) requires
each Federal agency to assess the effects
of Federal regulatory actions on State,
local, and Tribal governments and the
private sector. Public Law 104–4, sec.
201 (codified at 2 U.S.C. 1531). For
regulatory actions likely to result in a
rule that may cause the expenditure by
State, local, and Tribal governments, in
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38987
the aggregate, or by the private sector of
$100 million or more in any one year
(adjusted annually for inflation), section
202 of UMRA requires a Federal agency
to publish a written statement that
estimates the resulting costs, benefits,
and other effects on the national
economy. (2 U.S.C. 1532(a), (b)) UMRA
also requires a Federal agency to
develop an effective process to permit
timely input by elected officers of State,
local, and Tribal governments on a
‘‘significant intergovernmental
mandate,’’ and requires an agency plan
for giving notice and opportunity for
timely input to potentially affected
small governments before establishing
any requirements that might
significantly or uniquely affect them. On
March 18, 1997, DOE published a
statement of policy on its process for
intergovernmental consultation under
UMRA. 62 FR 12820. (This policy is
also available at https://energy.gov/gc/
office-general-counsel.) DOE examined
this proposed rule according to UMRA
and its statement of policy and has
tentatively determined that the rule
contains neither an intergovernmental
mandate, nor a mandate that may result
in the expenditure by State, local, and
Tribal government, in the aggregate, or
by the private sector, of $100 million or
more in any year. Accordingly, no
further assessment or analysis is
required under UMRA.
G. Treasury and General Government
Appropriations Act, 1999
Section 654 of the Treasury and
General Government Appropriations
Act, 1999, 5 U.S.C. 601 note, requires
Federal agencies to issue a Family
Policymaking Assessment for any
proposed rule that may affect family
wellbeing. While this proposed rule
would apply to individuals who may be
members of a family, the rule would not
have any impact on the autonomy or
integrity of the family as an institution.
Accordingly, DOE has concluded that it
is not necessary to prepare a Family
Policymaking Assessment.
H. Executive Order 13132
Executive Order 13132, ‘‘Federalism,’’
64 FR 43255 (Aug. 4, 1999), imposes
certain requirements on agencies
formulating and implementing policies
or regulations that preempt State law or
that have federalism implications.
Agencies are required to examine the
constitutional and statutory authority
supporting any action that would limit
the policymaking discretion of the
States and carefully assess the necessity
for such actions. DOE has examined this
proposed rule and has determined that
it would not preempt State law and
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would not have a substantial direct
effect on the States, on the relationship
between the national government and
the States, or on the distribution of
power and responsibilities among the
various levels of government. No further
action is required by Executive Order
13132.
I. Executive Order 12988
With respect to the review of existing
regulations and the promulgation of
new regulations, section 3(a) of
Executive Order 12988, ‘‘Civil Justice
Reform,’’ 61 FR 4729 (Feb. 7, 1996),
imposes on Executive agencies the
general duty to adhere to the following
requirements: (1) Eliminate drafting
errors and ambiguity; (2) write
regulations to minimize litigation; and
(3) provide a clear legal standard for
affected conduct rather than a general
standard and promote simplification
and burden reduction. With regard to
the review required by section 3(a),
section 3(b) of Executive Order 12988
specifically requires that Executive
agencies make every reasonable effort to
ensure that the regulation: (1) Clearly
specifies the preemptive effect, if any;
(2) clearly specifies any effect on
existing Federal law or regulation; (3)
provides a clear legal standard for
affected conduct while promoting
simplification and burden reduction; (4)
specifies the retroactive effect, if any; (5)
adequately defines key terms; and (6)
addresses other important issues
affecting clarity and general
draftsmanship under any guidelines
issued by the Attorney General. Section
3(c) of Executive Order 12988 requires
Executive agencies to review regulations
in light of applicable standards in
section 3(a) and section 3(b) to
determine whether they are met or it is
unreasonable to meet one or more of
them. DOE has completed the required
review and determined that, to the
extent permitted by law, this proposed
rule meets the relevant standards of
Executive Order 12988.
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J. Treasury and General Government
Appropriations Act, 2001
The Treasury and General
Government Appropriations Act, 2001,
44 U.S.C. 3516 note, provides for
agencies to review most disseminations
of information to the public under
guidelines established by each agency
pursuant to general guidelines issued by
OMB. OMB’s guidelines were published
at 67 FR 8452 (Feb. 22, 2002), and
DOE’s guidelines were published at 67
FR 62446 (Oct. 7, 2002). DOE has
reviewed this proposed rule under the
OMB and DOE guidelines and has
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concluded that it is consistent with
applicable policies in those guidelines.
K. Executive Order 13211
Executive Order 13211, ‘‘Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use,’’ 66 FR 28355 (May
22, 2001), requires Federal agencies to
prepare and submit to the Office of
Information and Regulatory Affairs
(OIRA) a Statement of Energy Effects for
any proposed significant energy action.
A ‘‘significant energy action’’ is defined
as any action by an agency that
promulgated or is expected to lead to
promulgation of a final rule, and that:
(1) Is a significant regulatory action
under Executive Order 12866, or any
successor order; and (2) is likely to have
a significant adverse effect on the
supply, distribution, or use of energy, or
(3) is designated by the Administrator of
OIRA as a significant energy action. For
any proposed significant energy action,
the agency must give a detailed
statement of any adverse effects on
energy supply, distribution, or use
should the proposal be implemented,
and of reasonable alternatives to the
action and their expected benefits on
energy supply, distribution, and use.
This regulatory action has been
determined to not be a significant
regulatory action, and it would not have
an adverse effect on the supply,
distribution, or use of energy. Thus, this
action is not a significant energy action.
Accordingly, DOE has not prepared a
Statement of Energy Effects.
V. Approval of the Office of the
Secretary
The Secretary of Energy has approved
the publication of this proposed rule.
List of Subjects in 10 CFR Part 830
Administrative practice and
procedure, DOE contracts, Environment,
Federal buildings and facilities,
Government contracts, Nuclear
materials, Nuclear power plants and
reactors, Nuclear safety, Penalties,
Public health, Reporting and
recordkeeping requirements, and Safety.
Issued in Washington, DC, on August 1,
2018.
Dan Brouillette,
Deputy Secretary of Energy.
For the reasons stated in the
preamble, DOE proposes to revise 10
CFR part 830 to read as follows:
PART 830—NUCLEAR SAFETY
MANAGEMENT
Sec.
830.1
830.2
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Exclusions.
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830.3
830.4
830.5
830.6
830.7
Definitions.
General requirements.
Enforcement.
Recordkeeping.
Graded approach.
Subpart A—Quality Assurance
Requirements
830.120 Scope.
830.121 Quality Assurance Program (QAP).
830.122 Quality assurance criteria.
Subpart B—Safety Basis Requirements
830.200 Scope.
830.201 Performance of work.
830.202 Safety basis.
830.203 Unreviewed safety question
process.
830.204 Documented safety analysis.
830.205 Technical safety requirements.
830.206 Preliminary documented safety
analysis.
830.207 DOE approval of safety basis.
Appendix A to Subpart B to Part 830—
General Statement of Safety Basis Policy
Authority: 42 U.S.C. 2201; 42 U.S.C. 7101
et seq.; and 50 U.S.C. 2401 et seq.
§ 830.1
Scope.
This part governs the conduct of DOE
contractors, DOE personnel, and other
persons conducting activities (including
providing items and services) that affect,
or may affect, the safety of DOE nuclear
facilities.
§ 830.2
Exclusions.
This part does not apply to:
(a) Activities that are regulated
through a license by the Nuclear
Regulatory Commission (NRC) or a State
under an Agreement with the NRC,
including activities certified by the NRC
under section 1701 of the Atomic
Energy Act (Act);
(b) Activities conducted under the
authority of the Director, Naval Nuclear
Propulsion, pursuant to Executive Order
12344, as set forth in Public Law 106–
65;
(c) Transportation activities which are
regulated by the Department of
Transportation;
(d) Activities conducted under the
Nuclear Waste Policy Act of 1982, as
amended, and any facility identified
under section 202(5) of the Energy
Reorganization Act of 1974, as
amended; and
(e) Activities related to the launch
approval and actual launch of nuclear
energy systems into space.
§ 830.3
Definitions.
(a) The following definitions apply to
this part:
Administrative controls means the
provisions relating to organization and
management, procedures,
recordkeeping, assessment, and
reporting necessary to ensure safe
operation of a facility.
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Bases appendix means an appendix
that describes the basis of the limits and
other requirements in technical safety
requirements.
Critical assembly means special
nuclear devices designed and used to
sustain nuclear reactions, which may be
subject to frequent core and lattice
configuration change and which
frequently may be used as mockups of
reactor configurations.
Criticality means the condition in
which a nuclear fission chain reaction
becomes self-sustaining.
Design features means the design
features of a nuclear facility specified in
the technical safety requirements that, if
altered or modified, would have a
significant effect on safe operation.
Document means recorded
information that describes, specifies,
reports, certifies, requires, or provides
data or results.
Documented safety analysis means a
documented analysis of the extent to
which a nuclear facility can be operated
safely with respect to workers, the
public, and the environment, including
a description of the conditions, safe
boundaries, and hazard controls that
provide the basis for ensuring safety.
Environmental restoration activities
means the process(es) by which
contaminated sites and facilities are
identified and characterized and by
which contamination is contained,
treated, or removed and disposed.
Fissionable materials means a nuclide
capable of sustaining a neutron-induced
chain reaction (e.g., uranium-233,
uranium-235, plutonium-238,
plutonium-239, plutonium-241,
neptunium-237, americium-241, and
curium-244).
Graded approach means the process
of ensuring that the level of analysis,
documentation, and actions used to
comply with a requirement in this part
are commensurate with:
(i) The relative importance to safety,
safeguards, and security;
(ii) The magnitude of any hazard
involved;
(iii) The life cycle stage of a facility;
(iv) The programmatic mission of a
facility;
(v) The particular characteristics of a
facility;
(vi) The relative importance of
radiological and nonradiological
hazards; and
(vii) Any other relevant factor.
Hazard means a source of danger (i.e.,
material, energy source, or operation)
with the potential to cause illness,
injury, or death to a person or damage
to a facility or to the environment
(without regard to the likelihood or
credibility of accident scenarios or
consequence mitigation).
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Hazard Category 1, 2, and 3 DOE
nuclear facilities means nuclear
facilities that meet the criteria for their
respective hazard category consistent
with the provisions of DOE–STD–1027–
92, Change Notice 1, or successor
document. Hazard Category 1, 2, and 3
DOE nuclear facilities are required to
have safety bases established in
accordance with Subpart B of this part.
Hazard categories are based on their
radioactive material inventories and the
potential consequences to the public,
workers, and the environment. Hazard
Category 1 represents the highest
potential consequence and Hazard
Category 3 represents the lowest
potential consequence of the facilities
required to establish safety bases.
Hazard controls means measures to
eliminate, limit, or mitigate hazards to
workers, the public, or the environment,
including
(i) Physical, design, structural, and
engineering features;
(ii) Safety structures, systems, and
components;
(iii) Safety management programs;
(iv) Technical safety requirements;
and
(v) Other controls necessary to
provide adequate protection from
hazards.
Item is an all-inclusive term used in
place of any of the following:
Appurtenance, assembly, component,
equipment, material, module, part,
product, structure, subassembly,
subsystem, system, unit, or support
systems.
Limiting conditions for operation
means the limits that represent the
lowest functional capability or
performance level of safety structures,
systems, and components required for
safe operations.
Limiting control settings means the
settings on safety systems that control
process variables to prevent exceeding a
safety limit.
Low-level residual fixed radioactivity
means the remaining radioactivity
following reasonable efforts to remove
radioactive systems, components, and
stored materials. The remaining
radioactivity is composed of surface
contamination that is fixed following
chemical cleaning or some similar
process; a component of surface
contamination that can be picked up by
smears; or activated materials within
structures. The radioactivity can be
characterized as low-level if the
smearable radioactivity is less than the
values defined for removable
contamination by 10 CFR part 835,
Appendix D, Surface Contamination
Values, and the hazard analysis results
show that no credible accident scenario
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or work practices would release the
remaining fixed radioactivity or
activation components at levels that
would prudently require the use of
active safety systems, structures, or
components to prevent or mitigate a
release of radioactive materials.
Major modification means a
modification to a DOE nuclear facility
that substantially changes the existing
safety basis for the facility.
New Hazard Category 1, 2, and 3 DOE
nuclear facility means a Hazard
Category 1, 2, or 3 DOE nuclear facility
that is in design or under construction
that does not yet have a DOE approved
safety basis.
Nonreactor nuclear facility means
those facilities, activities or operations
that involve, or will involve, radioactive
and/or fissionable materials in such
form and quantity that a nuclear or a
nuclear explosive hazard potentially
exists to workers, the public, or the
environment, but does not include
accelerators and their operations and
does not include activities involving
only incidental use and generation of
radioactive materials or radiation such
as check and calibration sources, use of
radioactive sources in research and
experimental and analytical laboratory
activities, electron microscopes, and Xray machines.
Nuclear facility means a reactor or a
nonreactor nuclear facility where an
activity is conducted for or on behalf of
DOE and includes any related area,
structure, facility, or activity to the
extent necessary to ensure proper
implementation of the requirements
established by this Part.
Operating limits means those limits
required to ensure the safe operation of
a nuclear facility, including limiting
control settings and limiting conditions
for operation.
Preliminary documented safety
analysis means documentation prepared
in connection with the design and
construction of a new Hazard Category
1, 2, or 3 DOE nuclear facility or a major
modification to an existing Hazard
Category 1, 2, or 3 DOE nuclear facility
that provides a reasonable basis for the
preliminary conclusion that the nuclear
facility can be operated safely through
the consideration of factors such as:
(i) The nuclear safety design criteria
to be satisfied;
(ii) A safety analysis that derives
aspects of design that are necessary to
satisfy the nuclear safety design criteria;
and
(iii) An initial listing of the safety
management programs that must be
developed to address operational safety
considerations.
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Process means a series of actions that
achieves an end or result.
Quality means the condition achieved
when an item, service, or process meets
or exceeds the user’s requirements and
expectations.
Quality assurance means all those
actions that provide confidence that
quality is achieved.
Quality Assurance Program (QAP)
means the overall program or
management system established to
assign responsibilities and authorities,
define policies and requirements, and
provide for the performance and
assessment of work.
Reactor means any apparatus that is
designed or used to sustain nuclear
chain reactions in a controlled manner
such as research, test, and power
reactors, and critical and pulsed
assemblies and any assembly that is
designed to perform subcritical
experiments that could potentially reach
criticality; and, unless modified by
words such as containment, vessel, or
core, refers to the entire facility,
including the housing, equipment and
associated areas devoted to the
operation and maintenance of one or
more reactor cores.
Record means a completed document
or other media that provides objective
evidence of an item, service, or process.
Safety basis means the documented
safety analysis and hazard controls that
provide reasonable assurance that a
DOE nuclear facility can be operated
safely in a manner that adequately
protects workers, the public, and the
environment.
Safety class structures, systems, and
components means the structures,
systems, or components, including
portions of process systems, whose
preventive or mitigative function is
necessary to limit radioactive hazardous
material exposure to the public, as
determined from safety analyses.
Safety evaluation report means the
report prepared by DOE to document:
(i) The sufficiency of the documented
safety analysis for a Hazard Category 1,
2, or 3 DOE nuclear facility;
(ii) The extent to which a contractor
has satisfied the requirements of
Subpart B of this part; and
(iii) The basis for approval by DOE of
the safety basis for the facility,
including any conditions for approval.
Safety limits means the limits on
process variables associated with those
safety class physical barriers, generally
passive, that are necessary for the
intended facility function and that are
required to guard against the
uncontrolled release of radioactive
materials.
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Safety management program means a
program designed to ensure a facility is
operated in a manner that adequately
protects workers, the public, and the
environment by covering a topic such
as: Quality assurance; maintenance of
safety systems; personnel training;
conduct of operations; inadvertent
criticality protection; emergency
preparedness; fire protection; waste
management; or radiological protection
of workers, the public, and the
environment.
Safety management system means an
integrated safety management system
established consistent with 48 CFR
970.5223–1, Integration of environment,
safety, and health into work planning
and execution.
Safety significant structures, systems,
and components means the structures,
systems, and components which are not
designated as safety class structures,
systems, and components, but whose
preventive or mitigative function is a
major contributor to defense in depth
and/or worker safety as determined
from safety analyses.
Safety structures, systems, and
components means both safety class
structures, systems, and components
and safety significant structures,
systems, and components.
Service means the performance of
work, such as design, manufacturing,
construction, fabrication, assembly,
decontamination, environmental
restoration, waste management,
laboratory sample analyses, inspection,
nondestructive examination/testing,
environmental qualification, equipment
qualification, repair, installation, or the
like.
Surveillance requirements means
requirements relating to test, calibration,
or inspection to ensure that the
necessary operability and quality of
safety structures, systems, and
components and their support systems
required for safe operations are
maintained, that facility operation is
within safety limits, and that limiting
control settings and limiting conditions
for operation are met.
Technical safety requirements (TSRs)
means the limits, controls, and related
actions that establish the specific
parameters and requisite actions for the
safe operation of a nuclear facility and
include, as appropriate for the work and
the hazards identified in the
documented safety analysis for the
facility: Safety limits, operating limits,
surveillance requirements,
administrative and management
controls, use and application
provisions, and design features, as well
as a bases appendix.
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Unreviewed Safety Question (USQ)
means a situation where:
(i) The probability of the occurrence
or the consequences of an accident or
the malfunction of equipment important
to safety previously evaluated in the
documented safety analysis could be
increased;
(ii) The possibility of an accident or
malfunction of a different type than any
evaluated previously in the documented
safety analysis could be created; or
(iii) The documented safety analysis
may not be bounding or may be
otherwise inadequate.
Unreviewed Safety Question process
means the mechanism for keeping a
safety basis current by reviewing
potential unreviewed safety questions,
reporting unreviewed safety questions
to DOE, and obtaining approval from
DOE prior to taking any action that
involves an unreviewed safety question.
Use and application provisions means
the basic instructions for applying
technical safety requirements.
(b) Terms defined in the Act or in 10
CFR part 820 and not defined in this
section of the rule are to be used
consistent with the meanings given in
the Act or in 10 CFR part 820.
§ 830.4
General requirements.
(a) No person may take or cause to be
taken any action inconsistent with the
requirements of this part.
(b) A contractor responsible for a
nuclear facility must ensure
implementation of, and compliance
with, the requirements of this part.
(c) The requirements of this part must
be implemented in a manner that
provides reasonable assurance of
adequate protection of workers, the
public, and the environment from
adverse consequences, taking into
account the work to be performed and
the associated hazards.
(d) If there is no contractor for a DOE
nuclear facility, DOE must ensure
implementation of, and compliance
with, the requirements of this part.
§ 830.5
Enforcement.
The requirements in this part are DOE
Nuclear Safety Requirements and are
subject to enforcement by all
appropriate means, including the
imposition of civil and criminal
penalties in accordance with the
provisions of 10 CFR part 820.
§ 830.6
Recordkeeping.
A contractor must maintain complete
and accurate records as necessary to
substantiate compliance with the
requirements of this part.
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§ 830.7
Graded approach.
§ 830.122
Where appropriate, a contractor must
use a graded approach to implement the
requirements of this part, document the
basis of the graded approach used, and
submit that documentation to DOE. The
graded approach may not be used in
implementing the unreviewed safety
question (USQ) process or in
implementing technical safety
requirements.
Subpart A—Quality Assurance
Requirements
§ 830.120
Scope.
This subpart establishes quality
assurance requirements for contractors
conducting activities, including
providing items or services that affect,
or may affect, nuclear safety of DOE
nuclear facilities.
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§ 830.121
(QAP).
Quality Assurance Program
(a) Contractors conducting activities,
including providing items or services,
that affect, or may affect, the nuclear
safety of DOE nuclear facilities must
conduct work in accordance with the
Quality Assurance criteria in § 830.122.
(b) The contractor responsible for a
DOE nuclear facility must:
(1) Submit a QAP to DOE for approval
and regard the QAP as approved 90 days
after submittal, unless it is approved or
rejected by DOE at an earlier date.
(2) Modify the QAP as directed by
DOE.
(3) Annually submit any changes to
the DOE-approved QAP to DOE for
approval. Justify in the submittal why
the changes continue to satisfy the
quality assurance requirements.
(4) Conduct work in accordance with
the QAP.
(c) The QAP must:
(1) Describe how the quality
assurance criteria of § 830.122 are
satisfied.
(2) Integrate the quality assurance
criteria with the Safety Management
System, or describe how the quality
assurance criteria apply to the Safety
Management System.
(3) Use voluntary consensus standards
in its development and implementation,
where practicable and consistent with
contractual and regulatory
requirements, and identify the standards
used.
(4) Describe how the contractor
responsible for the nuclear facility
ensures that subcontractors and
suppliers satisfy the criteria of
§ 830.122.
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Quality assurance criteria.
The QAP must address the following
management, performance, and
assessment criteria:
(a) Criterion 1—Management/
Program. (1) Establish an organizational
structure, functional responsibilities,
levels of authority, and interfaces for
those managing, performing, and
assessing the work.
(2) Establish management processes,
including planning, scheduling, and
providing resources for the work.
(b) Criterion 2—Management/
Personnel Training and Qualification.
(1) Train and qualify personnel to be
capable of performing their assigned
work.
(2) Provide continuing training to
personnel to maintain their job
proficiency.
(c) Criterion 3—Management/Quality
Improvement. (1) Establish and
implement processes to detect and
prevent quality problems.
(2) Identify, control, and correct
items, services, and processes that do
not meet established requirements.
(3) Identify the causes of problems
and work to prevent recurrence as a part
of correcting the problem.
(4) Review item characteristics,
process implementation, and other
quality-related information to identify
items, services, and processes needing
improvement.
(d) Criterion 4—Management/
Documents and Records. (1) Prepare,
review, approve, issue, use, and revise
documents to prescribe processes,
specify requirements, or establish
design.
(2) Specify, prepare, review, approve,
and maintain records.
(e) Criterion 5—Performance/Work
Processes. (1) Perform work consistent
with technical standards, administrative
controls, and other hazard controls
adopted to meet regulatory or contract
requirements, using approved
instructions, procedures, or other
appropriate means.
(2) Identify and control items to
ensure their proper use.
(3) Maintain items to prevent their
damage, loss, or deterioration.
(4) Calibrate and maintain equipment
used for process monitoring or data
collection.
(f) Criterion 6—Performance/Design.
(1) Design items and processes using
sound engineering/scientific principles
and appropriate standards.
(2) Incorporate applicable
requirements and design bases in design
work and design changes.
(3) Identify and control design
interfaces.
(4) Verify or validate the adequacy of
design products using individuals or
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groups other than those who performed
the work.
(5) Verify or validate work before
approval and implementation of the
design.
(g) Criterion 7—Performance/
Procurement. (1) Procure items and
services that meet established
requirements and perform as specified.
(2) Evaluate and select prospective
suppliers on the basis of specified
criteria.
(3) Establish and implement processes
to ensure that approved suppliers
continue to provide acceptable items
and services.
(h) Criterion 8—Performance/
Inspection and Acceptance Testing. (1)
Inspect and test specified items,
services, and processes using
established acceptance and performance
criteria.
(2) Calibrate and maintain equipment
used for inspections and tests.
(i) Criterion 9—Assessment/
Management Assessment. Ensure
managers assess their management
processes and identify and correct
problems that hinder the organization
from achieving its objectives.
(j) Criterion 10—Assessment/
Independent Assessment. (1) Plan and
conduct independent assessments to
measure item and service quality, to
measure the adequacy of work
performance, and to promote
improvement.
(2) Establish sufficient authority, and
freedom from line management, for the
group performing independent
assessments.
(3) Ensure persons who perform
independent assessments are
technically qualified and knowledgeable
in the areas to be assessed.
Subpart B—Safety Basis Requirements
§ 830.200
Scope.
This Subpart establishes safety basis
requirements for Hazard Category 1, 2,
and 3 DOE nuclear facilities.
§ 830.201
Performance of work.
A contractor must perform work in
accordance with the DOE-approved
safety basis for a Hazard Category 1, 2,
or 3 DOE nuclear facility and, in
particular, with the hazard controls that
ensure adequate protection of workers,
the public, and the environment.
§ 830.202
Safety basis.
(a) The contractor responsible for a
Hazard Category 1, 2, or 3 DOE nuclear
facility must establish and maintain the
safety basis for the facility.
(b) In establishing the safety basis for
a Hazard Category 1, 2, or 3 DOE
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nuclear facility, the contractor
responsible for the facility must:
(1) Define the scope of the work to be
performed;
(2) Identify and analyze the hazards
associated with the work;
(3) Categorize the facility consistent
with DOE–STD–1027–92 (‘‘Hazard
Categorization and Accident Analysis
Techniques for compliance with DOE
Order 5480.23, Nuclear Safety Analysis
Reports,’’ Change Notice 1, September
1997), or successor document;
(4) Prepare a documented safety
analysis for the facility; and
(5) Establish the hazard controls upon
which the contractor will rely to ensure
adequate protection of workers, the
public, and the environment.
(c) In maintaining the safety basis for
a Hazard Category 1, 2, or 3 DOE
nuclear facility, the contractor
responsible for the facility must:
(1) Update the safety basis to keep it
current and to reflect changes in the
facility, the work and the hazards as
they are analyzed in the documented
safety analysis;
(2) Annually provide DOE the current
documented safety analysis or a letter
stating that there have been no changes
in the documented safety analysis since
the prior submittal; and
(3) Incorporate in the safety basis any
changes, conditions, or hazard controls
directed by DOE.
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§ 830.203
process.
Unreviewed safety question
(a) The contractor responsible for a
Hazard Category 1, 2, or 3 DOE nuclear
facility must establish, implement, and
take actions consistent with a DOEapproved USQ procedure that meets the
requirements of this section.
(b) The contractor responsible for a
new Hazard Category 1, 2, or 3 DOE
nuclear facility must submit for DOE
approval a procedure for its USQ
process on a schedule that allows DOE
approval in a safety evaluation report
issued pursuant to section 207(a) of this
Part.
(c) The contractor responsible for a
Hazard Category 1, 2, or 3 DOE nuclear
facility must implement the DOEapproved USQ procedure in situations
where there is a:
(1) Temporary or permanent change
in the facility as described in the
existing documented safety analysis;
(2) Temporary or permanent change
in the procedures as described in the
existing documented safety analysis;
(3) Test or experiment not described
in the existing documented safety
analysis; or
(4) Potential inadequacy of the
documented safety analysis because the
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analysis potentially may not be
bounding or may be otherwise
inadequate.
(d) A contractor responsible for a
Hazard Category 1, 2, or 3 DOE nuclear
facility must obtain DOE approval prior
to taking any action determined to
involve a USQ.
(e) The contractor responsible for a
Hazard Category 1, 2, or 3 DOE nuclear
facility must annually provide to DOE a
summary of the USQ determinations
performed since the prior submittal.
(f) If a contractor responsible for a
Hazard Category 1, 2, or 3 DOE nuclear
facility discovers or is made aware of a
potential inadequacy of the documented
safety analysis, it must:
(1) Take action, as appropriate, to
place or maintain the facility in a safe
condition until an evaluation of the
safety of the situation is completed;
(2) Notify DOE of the situation;
(3) Perform a USQ determination and
notify DOE promptly of the results; and
(4) Submit the evaluation of the safety
of the situation to DOE prior to
removing any operational restrictions
initiated to meet paragraph (f)(1) of this
section.
§ 830.204
Documented safety analysis.
(a) The contractor responsible for a
Hazard Category 1, 2, or 3 DOE nuclear
facility must obtain approval from DOE
for the methodology used to prepare the
documented safety analysis for the
facility unless the contractor uses a
methodology set forth in Table 1 of
Appendix A to this Part.
(b) The documented safety analysis
for a Hazard Category 1, 2, or 3 DOE
nuclear facility must, as appropriate for
the complexities and hazards associated
with the facility:
(1) Describe the facility (including the
design of safety structures, systems and
components) and the work to be
performed;
(2) Provide a systematic identification
of both natural and man-made hazards
associated with the facility;
(3) Evaluate normal, abnormal, and
accident conditions, including
consideration of natural and man-made
external events, identification of energy
sources or processes that might
contribute to the generation or
uncontrolled release of radioactive and
other hazardous materials, and
consideration of the need for analysis of
accidents which may be beyond the
design basis of the facility;
(4) Derive the hazard controls
necessary to ensure adequate protection
of workers, the public, and the
environment, demonstrate the adequacy
of these controls to eliminate, limit, or
mitigate identified hazards, and define
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the process for maintaining the hazard
controls current at all times and
controlling their use;
(5) Define the characteristics of the
safety management programs necessary
to ensure the safe operation of the
facility, including (where applicable)
quality assurance, procedures,
maintenance, personnel training,
conduct of operations, emergency
preparedness, fire protection, waste
management, and radiation protection;
and
(6) With respect to a nonreactor
nuclear facility with fissionable material
in a form and amount sufficient to pose
a potential for criticality, define a
criticality safety program that:
(i) Ensures that operations with
fissionable material remain subcritical
under all normal and credible abnormal
conditions;
(ii) Identifies applicable nuclear
criticality safety standards; and
(iii) Describes how the program meets
applicable nuclear criticality safety
standards.
§ 830.205
Technical safety requirements.
(a) A contractor responsible for a
Hazard Category 1, 2, or 3 DOE nuclear
facility must:
(1) Develop technical safety
requirements that are derived from the
documented safety analysis;
(2) Prior to use, obtain DOE approval
of technical safety requirements and any
change to technical safety requirements;
and
(3) Notify DOE of any violation of a
technical safety requirement.
(b) A contractor may take emergency
actions that depart from an approved
technical safety requirement when no
actions consistent with the technical
safety requirement are immediately
apparent, and when these actions are
needed to protect workers, the public or
the environment from imminent and
significant harm. Such actions must be
approved by a certified operator for a
reactor or by a person in authority as
designated in the technical safety
requirements for nonreactor nuclear
facilities. The contractor must report the
emergency actions to DOE as soon as
practicable.
(c) A contractor for an environmental
restoration activity may follow the
provisions of 29 CFR 1910.120 or
1926.65 to develop the appropriate
hazard controls (rather than the
provisions for technical safety
requirements in paragraph (a) of this
section), provided the activity involves
either:
(1) Work not done within a permanent
structure, or
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(2) The decommissioning of a facility
with only low-level residual fixed
radioactivity.
§ 830.206
analysis.
Preliminary documented safety
Prior to construction of a new Hazard
Category 1, 2, or 3 DOE nuclear facility
or a major modification to an existing
Hazard Category 1, 2, or 3 DOE nuclear
facility, the contractor responsible for
the design and construction of the new
facility or major modification must:
(a) Prepare a preliminary documented
safety analysis for the facility, and
(b) Obtain DOE approval of:
(1) The nuclear safety design criteria
to be used in preparing the preliminary
documented safety analysis unless the
contractor uses the design criteria in
DOE Order 420.1, Facility Safety, or
successor document; and
(2) The preliminary documented
safety analysis before the contractor can
procure materials or components or
begin construction; provided that DOE
may authorize the contractor to perform
limited procurement and construction
activities without approval of a
preliminary documented safety analysis
if DOE determines that the activities are
not detrimental to public health and
safety and are in the best interests of
DOE.
§ 830.207
DOE approval of safety basis.
(a) With respect to a new Hazard
Category 1, 2, or 3 DOE nuclear facility
or a major modification to an existing
Hazard Category 1, 2, or 3 DOE nuclear
facility, a contractor may not begin
operation of the facility or modification
prior to the issuance of a safety
evaluation report in which DOE
approves the safety basis for the facility
or modification.
(b) Pending issuance of a safety
evaluation report in which DOE
approves an updated or amended safety
basis for an existing Hazard Category 1,
2, or 3 DOE nuclear facility, the
contractor responsible for the facility
must continue to perform work in
accordance with the DOE-approved
safety basis for the facility and maintain
the existing safety basis consistent with
the requirements of this Subpart.
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Appendix A to Subpart B to Part 830—
General Statement of Safety Basis
Policy
A. Introduction
This appendix describes DOE’s
expectations for the safety basis requirements
of 10 CFR part 830, acceptable methods for
implementing these requirements, and
criteria DOE will use to evaluate compliance
with these requirements. This Appendix does
not create any new requirements and should
be used consistently with DOE’s policy that
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work be conducted safely and efficiently and
in a manner that ensures protection of
workers, the public, and the environment.
B. Purpose
1. The safety basis requirements of part 830
require the contractor responsible for a DOE
nuclear facility to analyze the facility, the
work to be performed, and the associated
hazards and to identify the conditions, safe
boundaries, and hazard controls necessary to
protect workers, the public and the
environment from adverse consequences.
These analyses and hazard controls
constitute the safety basis upon which the
contractor and DOE rely to conclude that the
facility can be operated safely. Performing
work consistent with the safety basis
provides reasonable assurance of adequate
protection of workers, the public, and the
environment.
2. The safety basis requirements are
intended to further the objective of making
safety an integral part of how work is
performed throughout the DOE complex.
Developing a thorough understanding of a
nuclear facility, the work to be performed,
the associated hazards and the needed hazard
controls is essential to integrating safety into
management and work at all levels.
Performing work in accordance with the
safety basis for a nuclear facility is the
realization of that objective.
C. Scope
1. A contractor must establish and
maintain a safety basis for a Hazard Category
1, 2, or 3 DOE nuclear facility because these
facilities have the potential for significant
radiological consequences. DOE–STD–1027
sets forth the methodology for categorizing a
DOE nuclear facility based on the inventory
of radioactive materials.
2. Unlike the quality assurance
requirements of part 830 that apply to all
DOE nuclear facilities the safety basis
requirements only apply to Hazard Category
1, 2, and 3 DOE nuclear facilities and do not
apply to nuclear facilities below Hazard
Category 3.
D. Integrated Safety Management
1. The safety basis requirements are
consistent with integrated safety
management. DOE expects that, if a
contractor complies with the Department of
Energy Acquisition Regulation (DEAR) clause
on integration of environment, safety, and
health into work planning and execution (48
CFR 970.5223–1, Integration of Environment,
Safety and Health into Work Planning and
Execution) and the DEAR clause on laws,
regulations, and DOE directives (48 CFR
970.5204–2, Laws, Regulations and DOE
Directives), the contractor will have
established the foundation to meet the safety
basis requirements.
2. The processes embedded in a safety
management system should lead to a
contractor establishing adequate safety bases
and safety management programs that will
meet the safety basis requirements of this
Subpart. Consequently, the DOE expects if a
contractor has adequately implemented
integrated safety management, few additional
requirements will stem from this Subpart
and, in such cases, the existing safety basis
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prepared in accordance with integrated safety
management provisions, including existing
DOE safety requirements in contracts, should
meet the requirements of this Subpart.
3. DOE does not expect there to be any
conflict between contractual requirements
and regulatory requirements. In fact, DOE
expects that contract provisions will be used
to provide more detail on implementation of
safety basis requirements such as preparing
a documented safety analysis, developing
technical safety requirements, and
implementing a USQ process.
E. Enforcement of Safety Basis Requirements
1. Enforcement of the safety basis
requirements will be performance oriented.
That is, DOE will focus its enforcement
efforts on whether a contractor operates a
nuclear facility consistent with the safety
basis for the facility and, in particular,
whether work is performed in accordance
with the safety basis.
2. As part of the approval process, DOE
will review the content and quality of the
safety basis documentation. DOE intends to
use the approval process to assess the
adequacy of a safety basis developed by a
contractor to ensure that workers, the public,
and the environment are provided reasonable
assurance of adequate protection from
identified hazards. Once approved by DOE,
the safety basis documentation will not be
subject to regulatory enforcement actions
unless DOE determines that the information
which supports the documentation is not
complete and accurate in all material
respects, as required by 10 CFR 820.11. This
is consistent with the DOE enforcement
provisions and policy in 10 CFR part 820.
3. DOE does not intend the adoption of the
safety basis requirements to affect the
existing quality assurance requirements or
the existing obligation of contractors to
comply with the quality assurance
requirements. In particular, in conjunction
with the adoption of the safety basis
requirements, DOE revised the language in 10
CFR 830.122(e)(1) to make clear that hazard
controls are part of the work processes to
which a contractor and other persons must
adhere when performing work. This
obligation to perform work consistent with
hazard controls adopted to meet regulatory or
contract requirements existed prior to the
adoption of the safety basis requirements and
is both consistent with and independent of
the safety basis requirements.
4. A documented safety analysis must
address all hazards (that is, both radiological
and nonradiological hazards) and the
controls necessary to provide adequate
protection to the public, workers, and the
environment from these hazards. Section
234A of the Atomic Energy Act only
authorizes DOE to issue civil penalties for
violations of requirements related to nuclear
safety. Therefore, DOE will impose civil
penalties for violations of the safety basis
requirements (including hazard controls)
only if they are related to nuclear safety.
F. Documented Safety Analysis
1. A documented safety analysis must
demonstrate the extent to which a nuclear
facility can be operated safely with respect to
workers, the public, and the environment.
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2. DOE expects a contractor to use a graded
approach to develop a documented safety
analysis and describe how the graded
approach was applied. The level of detail,
analysis, and documentation will reflect the
complexity and hazards associated with a
particular facility. Thus, the documented
safety analysis for a simple, low hazard
facility may be relatively short and
qualitative in nature, while the documented
safety analysis for a complex, high hazard
facility may be quite elaborate and more
quantitative. DOE will work with its
contractors to ensure a documented safety
analysis is appropriate for the facility for
which it is being developed.
3. Because DOE has ultimate responsibility
for the safety of its facilities, DOE will review
each documented safety analysis as: (1) Part
of the initial submittal; (2) when revisions are
submitted as part of a positive USQ or major
modification; (3) if DOE has reason to believe
a portion of the safety basis to be inadequate,
or; (4) if DOE has reason to believe a portion
of the safety basis has substantially changed.
DOE will review the DSA to determine
whether the rigor and detail of the
documented safety analysis are appropriate
for the complexity and hazards expected at
the nuclear facility. In particular, DOE will
evaluate the documented safety analysis by
considering the extent to which the
documented safety analysis (1) satisfies the
provisions of the methodology used to
prepare the documented safety analysis and
(2) adequately addresses the criteria set forth
in 10 CFR 830.204(b). DOE will prepare a
Safety Evaluation Report to document the
results of its review of the documented safety
analysis. A documented safety analysis must
contain any conditions or changes required
by DOE in the Safety Evaluation Report.
Generally, DOE’s review of the annual
submittal may be limited to ensuring that the
results of USQs have been adequately
incorporated into the DSA. If additional
changes are proposed by the contractor and
included in the annual update that have not
been previously approved by DOE or have
not been evaluated as a part of the USQ
process, DOE must review and approve these
changes. DOE has the authority to review the
safety basis at any time.
4. In most cases, the contract will provide
the framework for specifying the
methodology and schedule for developing a
documented safety analysis. Table 1 sets
forth acceptable methodologies for preparing
a documented safety analysis.
TABLE 1
The contractor responsible for:
May prepare its document safety analysis by:
(1) A DOE reactor ...............................................
Using the method in U.S. Nuclear Regulatory Commission Regulatory Guide 1.70, Standard
Format and Content of Safety Analysis Reports for Nuclear Power Plants, or successor document.
Using the method in DOE–STD–3009, Change Notice No. 1, January 2000, Preparation Guide
for U.S. Department of Energy Nonreactor Nuclear Facility Safety Analysis Reports, July
1994, or successor document.
Using the method in either:
(1) DOE–STD–3009–, Change Notice No. 1, January 2000, or successor document, or
(2) DOE–STD–3011–94, Guidance for Preparation of DOE 5480.22 (TSR) and DOE 5480.23
(SAR) Implementation Plans, November 1994, or successor document.
Using the method in either:
(1) DOE–STD–3009, Change Notice No. 1, January 2000, or successor document, or
(2) DOE–STD–3011–94 or successor document.
(1) Using the method in DOE–STD–1120–98, Integration of Environment, Safety, and Health
into Facility Disposition Activities, May 1998, or successor document;
(2) Using the provisions in 29 CFR 1910.120 (or 29 CFR 1926.65 for construction activities)
for developing Safety and Health Programs, Work Plans, Health and Safety Plans, and
Emergency Response Plans to address public safety, as well as worker safety; and
(3) Deriving hazard controls based on the Safety and Health Programs, the Work Plans, the
Health and Safety Plans, and the Emergency Response Plans.
(1) Using the method in DOE–STD–1120–98 or successor document, and
(2) Using the provisions in 29 CFR 1910.120 (or 29 CFR 1926.65 for construction activities)
for developing a Safety and Health Program and a site-specific Health and Safety Plan (including elements for Emergency Response Plans, conduct of operations, training and qualifications, and maintenance management).
Developing its documented safety analysis in two pieces:
(1) A Safety Analysis Report for the nuclear facility that considers the generic nuclear explosive operations and is prepared in accordance with DOE–STD–3009, Change Notice No. 1,
January 2000, or successor document, and
(2) A Hazard Analysis Report for the specific nuclear explosive operations prepared in accordance with DOE–STD–3016–99, Hazards Analysis Reports for Nuclear Explosive Operations,
February 1999, or successor document.
Using the methods in Chapters 2, 3, 4, and 5 of DOE–STD–3009, Change Notice No. 1, January 2000, or successor document to ad- dress in a simplified fashion:
(1) The basic description of the facility/activity and its operations, including safety structures,
systems, and components;
(2) A qualitative hazards analysis; and
(3) The hazard controls (consisting primarily of inventory limits and safety management programs) and their bases.
(1) Preparing a Safety Analysis Report for Packaging in accordance with DOE–O–460.1A,
Packaging and Transportation Safety, October 2, 1996, or successor document and
(2) Preparing a Transportation Safety Document in accordance with DOE–G–460.1–1, Implementation Guide for Use with DOE O 460.1A, Packaging and Transportation Safety, June 5,
1997, or successor document.
(1) Preparing a Safety Analysis Report for Packaging in accordance with DOE–O–461.1,
Packaging and Transportation of Materials of National Security Interest, September 29,
2000, or successor document and
(2) Preparing a Transportation Safety Document in accordance with DOE–M–461.1–1, Packaging and Transfer of Materials of National Security Interest Manual, September 29, 2000,
or successor document.
(2) A DOE nonreactor nuclear facility ................
(3) A DOE nuclear facility with a limited operational life.
(4) The deactivation or the transition surveillance and maintenance of a DOE nuclear facility.
(5) The decommissioning of a DOE nuclear facility.
(6) A DOE environmental restoration activity
that involves either work not done within a
permanent structure or the decommissioning
of a facility with only low-level residual fixed
radioactivity.
(7) A DOE nuclear explosive facility and the nuclear explosive operations conducted therein..
(8) A DOE Hazard Category 3 nonreactor nuclear facility.
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(9) Transportation activities ................................
(10) Transportation and onsite transfer of nuclear explosives, nuclear components, Navel
nuclear fuel elements, Category I and Category II special nuclear materials, special assemblies, and other materials of national security.
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Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Proposed Rules
5. Table 1 refers to specific types of nuclear
facilities. These references are not intended
to constitute an exhaustive list of the specific
types of nuclear facilities. Part 830 defines
nuclear facility broadly to include reactor or
a nonreactor nuclear facilities where an
activity is conducted for or on behalf of DOE
and includes any related area, structure,
facility, or activity to the extent necessary to
ensure proper implementation of the
38995
requirements established by this Part. The
only exceptions are those facilities
specifically excluded such as accelerators.
Table 2 defines the terms referenced in Table
1 that are not defined in 10 CFR 830.3.
TABLE 2
For purposes of Table 1:
Means:
(1) Deactivation ...................................................
The process of placing a facility in a stable and known condition, including the removal of hazardous and radioactive materials.
The removal or reduction of residual radioactive and hazardous materials by mechanical,
chemical, or other techniques to achieve a stated objective or end condition.
Those actions taking place after deactivation of a nuclear facility to retire it from service and
includes surveillance and maintenance, decontamination, and/or dismantlement.
The process by which contaminated sites and facilities are identified and characterized and by
which existing contamination is contained, or removed and disposed.
A characterization that considers the collective attributes (such as special facility system requirements, physical weapon characteristics, or quantities and chemical/physical forms of
hazardous materials) for all projected nuclear explosive operations to be conducted at a facility.
A nuclear facility at which nuclear operations and activities involving a nuclear explosive may
be conducted.
Any activity involving a nuclear explosive, including activities in which main-charge, high-explosive parts and pits are collocated.
A nuclear facility for which there is a short remaining operational period before ending the facility’s mission and initiating deactivation and decommissioning and for which there are no
intended additional missions other than cleanup.
A specific nuclear explosive subjected to the stipulated steps of an individual operation, such
as assembly or disassembly.
Activities conducted when a facility is not operating or during deactivation, decontamination,
and decommissioning operations when surveillance and maintenance are the predominant
activities being conducted at the facility. These activities are necessary for satisfactory containment of hazardous materials and protection of workers, the public, and the environment.
These activities include providing periodic inspections, maintenance of structures, systems,
and components, and actions to prevent the alteration of hazardous materials to an unsafe
state.
(2) Decontamination ...........................................
(3) Decommissioning ..........................................
(4) Environmental restoration activities ..............
(5) Generic nuclear explosive operation ............
(6) Nuclear explosive facility ...............................
(7) Nuclear explosive operation ..........................
(8) Nuclear facility with a limited operational life
(9) Specific nuclear explosive operation ............
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(10) Transition surveillance and maintenance
activities.
6. The contractor responsible for the design
and construction of a new Hazard Category
1, 2, or 3 DOE nuclear facility or a major
modification to an existing Hazard Category
1, 2, or 3 DOE nuclear facility must prepare
a preliminary documented safety analysis. A
preliminary documented safety analysis can
ensure that substantial costs and time are not
wasted in constructing a nuclear facility that
will not be acceptable to DOE. If a contractor
is required to prepare a preliminary
documented safety analysis, the contractor
must obtain DOE approval of the preliminary
documented safety analysis prior to
procuring materials or components or
beginning construction. DOE, however, may
authorize the contractor to perform limited
procurement and construction activities
without approval of a preliminary
documented safety analysis if DOE
determines that the activities are not
detrimental to public health and safety and
are in the best interests of DOE. DOE Order
420.1, or successor document, sets forth
acceptable nuclear safety design criteria for
use in preparing a preliminary documented
safety analysis. As a general matter, DOE
does not expect preliminary documented
safety analyses to be needed for activities that
do not involve significant construction such
as environmental restoration activities,
decontamination and decommissioning
activities, specific nuclear explosive
operations, or transition surveillance and
maintenance activities.
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G. Hazard Controls
1. Hazard controls are measures to
eliminate, limit, or mitigate hazards to
workers, the public, or the environment.
They include: (1) Physical, design, structural,
and engineering features; (2) safety
structures, systems, and components; (3)
safety management programs; (4) technical
safety requirements; and (5) other controls
necessary to provide adequate protection
from hazards.
2. The types and specific characteristics of
the safety management programs necessary
for a DOE nuclear facility will be dependent
on the complexity and hazards associated
with the nuclear facility and the work being
performed. In most cases, however, a
contractor should consider safety
management programs covering topics such
as quality assurance, procedures,
maintenance, personnel training, conduct of
operations, criticality safety, emergency
preparedness, fire protection, waste
management, and radiation protection. In
general, DOE Orders set forth DOE’s
expectations concerning specific topics. For
example, DOE Order 420.1, or successor
document provides DOE’s expectations with
respect to fire protection and criticality
safety.
3. Safety structures, systems, and
components require formal definition of
minimum acceptable performance in the
documented safety analysis. This is
accomplished by first defining a safety
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function, then describing the structure,
systems, and components, placing functional
requirements on those portions of the
structures, systems, and components
required for the safety function, and
identifying performance criteria that will
ensure functional requirements are met.
Technical safety requirements are developed
to ensure the operability of the safety
structures, systems, and components and
define actions to be taken if a safety
structure, system, or component is not
operable.
4. Technical safety requirements establish
limits, controls, and related actions necessary
for the safe operation of a nuclear facility.
The exact form and contents of technical
safety requirements will depend on the
circumstances of a particular nuclear facility
as defined in the documented safety analysis
for the nuclear facility. As appropriate,
technical safety requirements may have
sections on: (1) Safety limits; (2) operating
limits; (3) surveillance requirements; (4)
administrative controls; (5) use and
application; and (6) design features. It may
also have an appendix on the bases for the
limits and requirements. DOE Guide 423.1–
1B, Implementation Guide for Use in
Developing Technical Safety Requirements,
or successor document, provides a complete
description of what technical safety
requirements should contain and how they
should be developed and maintained.
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Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Proposed Rules
5. DOE will examine and approve the
technical safety requirements as part of
preparing the safety evaluation report and
reviewing updates to the safety basis. As with
all hazard controls, technical safety
requirements must be kept current and reflect
changes in the facility, the work and the
hazards as they are analyzed in the
documented safety analysis. In addition, DOE
expects a contractor to maintain technical
safety requirements, and other hazard
controls as appropriate, as controlled
documents with an authorized users list.
6. Table 3 sets forth DOE’s expectations
concerning acceptable technical safety
requirements.
TABLE 3
As appropriate for a particular DOE nuclear
facility, the section of the technical safety
requirements on:
Will provide information on:
(1) Safety limits ...................................................
(2) Operating limits .............................................
(3) Limiting control settings ................................
(4) Limiting conditions for operations .................
(5) Surveillance requirements .............................
(6) Administrative controls ..................................
(7) Use and application provisions .....................
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(8) Design features .............................................
(9) Bases appendix .............................................
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The limits on process variables associated with those safety class physical barriers, generally
passive, that are necessary for the intended facility function and that are required to guard
against the uncontrolled release of radioactive materials. The safety limit section describes,
as precisely as possible, the parameters being limited, states the limit in measurable units
(pressure, temperature, flow, etc.), and indicates the applicability of the limit. The safety limit
section also describes the actions to be taken in the event that the safety limit is exceeded.
These actions should first place the facility in the safe, stable condition attainable, including
total shutdown (except where such action might reduce the margin of safety) or should
verify that the facility already is safe and stable and will remain so. The technical safety requirement should state that the contractor must obtain DOE authorization to restart the nuclear facility following a violation of a safety limit. The safety limit section also establishes
the steps and time limits to correct the out-of-specification condition.
Those limits which are required to ensure the safe operation of a nuclear facility. The operating limits section may include subsections on limiting control settings and limiting conditions for operation.
The settings on safety systems that control process variables to prevent exceeding a safety
limit. The limited control settings section normally contains the settings for automatic alarms
and for the automatic or non-automatic initiation of protective actions related to those variables associated with the function of safety class structures, systems, or components if the
safety analysis shows that they are relied upon to mitigate or prevent an accident. The limited control settings section also identifies the protective actions to be taken at the specific
settings chosen in order to correct a situation automatically or manually such that the related
safety limit is not exceeded. Protective actions may include maintaining the variables within
the requirements and repairing the automatic device promptly or shutting down the affected
part of the process and, if required, the entire facility.
The limits that represent the lowest functional capability or performance level of safety structures, systems, and components required to perform an activity safely. The limiting conditions for operation section describes, as precisely as possible, the lowest functional capability or performance level of equipment required for continued safe operation of the facility.
The limiting conditions for operation section also states the action to be taken to address a
condition not meeting the limiting conditions for operation section. Normally this simply provides for the adverse condition being corrected in a certain time frame and for further action
if this is impossible.
Requirements relating to test, calibration, or inspection to assure that the necessary operability
and quality of safety structures, systems, and components is maintained; that facility operation is within safety limits; and that limiting control settings and limiting conditions for operation are met. If a required surveillance is not successfully completed, the contractor is expected to assume the systems or components involved are inoperable and take the actions
defined by the technical safety requirement until the systems or components can be shown
to be operable. If, however, a required surveillance is not performed within its required frequency, the contractor is allowed to perform the surveillance within 24 hours or the original
frequency, whichever is smaller, and confirm operability.
Organization and management, procedures, recordkeeping, assessment, and reporting necessary to ensure safe operation of a facility consistent with the technical safety requirement.
In general, the administrative controls section addresses (1) the requirements associated
with administrative controls, (including those for reporting violations of the technical safety
requirement); (2) the staffing requirements for facility positions important to safe conduct of
the facility; and (3) the commitments to the safety management programs identified in the
documented safety analysis as necessary components of the safety basis for the facility.
The basic instructions for applying the safety restrictions contained in a technical safety requirement. The use and application section includes definitions of terms, operating modes,
logical connectors, completion times, and frequency notations.
Design features of the facility that, if altered or modified, would have a significant effect on
safe operation.
The reasons for the safety limits, operating limits, and associated surveillance requirements in
the technical safety requirements. The statements for each limit or requirement shows how
the numeric value, the condition, or the surveillance fulfills the purpose derived from the
safety documentation. The primary purpose for describing the basis of each limit or requirement is to ensure that any future changes to the limit or requirement is done with full knowledge of the original intent or purpose of the limit or requirement.
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Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Proposed Rules
H. Unreviewed Safety Questions
1. The USQ process is an important tool to
evaluate whether changes affect the safety
basis. A contractor must use the USQ process
to ensure that the safety basis for a DOE
nuclear facility is not undermined by
changes in the facility, the work performed,
the associated hazards, or other factors that
support the adequacy of the safety basis.
2. The USQ process permits a contractor to
make physical and procedural changes to a
nuclear facility and to conduct tests and
experiments without prior approval,
provided these changes do not cause a USQ.
The USQ process provides a contractor with
the flexibility needed to conduct day-to-day
operations by requiring only those changes
and tests with a potential to impact the safety
basis (and therefore the safety of the nuclear
facility) be approved by DOE. This allows
DOE to focus its review on those changes
significant to safety. The USQ process helps
keep the safety basis current by ensuring
appropriate review of and response to
situations that might adversely affect the
safety basis.
3. DOE Guide 424.1–1B Chg 2,
Implementation Guide for Use in Addressing
Unreviewed Safety Question Requirements,
or successor document provides DOE’s
expectations for a USQ process. The
contractor must obtain DOE approval of its
procedure used to implement the USQ
process. The contractor is allowed to make
editorial and format changes to its USQ
procedure while maintaining DOE approval.
I. Functions and Responsibilities
1. The DOE Management Official for a DOE
nuclear facility (that is, the Assistant
Secretary, the Assistant Administrator, or the
Office Director who is primarily responsible
for the management of the facility) has
primary responsibility within DOE for
ensuring that the safety basis for the facility
is adequate and complies with the safety
basis requirements of Part 830. The DOE
Management Official is responsible for
ensuring the timely and proper (1) review of
all safety basis documents submitted to DOE
and (2) preparation of a safety evaluation
report concerning the safety basis for a
facility.
2. DOE will maintain a public list on the
internet that provides the status of the safety
basis for each Hazard Category 1, 2, or 3 DOE
nuclear facility and, to the extent practicable,
provides information on how to obtain a
copy of the safety basis and related
documents for a facility.
[FR Doc. 2018–16863 Filed 8–7–18; 8:45 am]
BILLING CODE 6450–01–P
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NATIONAL CREDIT UNION
ADMINISTRATION
12 CFR Part 702
RIN 3133–AE90
Risk-Based Capital—Supplemental
Rule
National Credit Union
Administration (NCUA).
AGENCY:
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ACTION:
Proposed rule.
The NCUA Board (Board) is
seeking comment on a proposed rule
that would amend the NCUA’s
previously revised regulations regarding
prompt corrective action (PCA). The
proposal would delay the effective date
of the NCUA’s October 29, 2015 final
rule regarding risk-based capital (2015
Final Rule) for one year, moving the
effective date from January 1, 2019 to
January 1, 2020. During the extended
delay period, the NCUA’s current PCA
requirements would remain in effect.
The proposal would also amend the
definition of a ‘‘complex’’ credit union
adopted in the 2015 Final Rule for riskbased capital purposes by increasing the
threshold level for coverage from $100
million to $500 million. These proposed
changes would provide covered credit
unions and the NCUA with additional
time to prepare for the rule’s
implementation, and would exempt an
additional 1,026 credit unions from the
rule without subjecting the National
Credit Union Share Insurance Fund
(NCUSIF) to undue risk.
DATES: Comments must be received by
September 7, 2018.
ADDRESSES: You may submit written
comments, identified by RIN 3133–
AE90, by any of the following methods
(Please send comments by one method
only):
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• NCUA website: https://
www.ncua.gov/Legal/Regs/Pages/
PropRegs.aspx. Follow the instructions
for submitting comments.
• Email: Address to regcomments@
ncua.gov. Include ‘‘[Your name]—
Comments on Proposed Rule: RiskBased Capital—Supplemental Proposal’’
in the email subject line.
• Fax: (703) 518–6319. Use the
subject line described above for email.
• Mail: Address to Gerard Poliquin,
Secretary of the Board, National Credit
Union Administration, 1775 Duke
Street, Alexandria, Virginia 22314–
3428.
• Hand Delivery/Courier: Same as
mail address.
You can view all public comments on
the NCUA’s website at https://
www.ncua.gov/Legal/Regs/Pages/
PropRegs.aspx as submitted, except for
those we cannot post for technical
reasons. The NCUA will not edit or
remove any identifying or contact
information from the public comments
submitted. You may inspect paper
copies of comments in the NCUA’s law
library at 1775 Duke Street, Alexandria,
Virginia 22314, by appointment
SUMMARY:
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38997
weekdays between 9 a.m. and 3 p.m. To
make an appointment, call (703) 518–
6546, or send an email to OGCMail@
ncua.gov.
FOR FURTHER INFORMATION CONTACT:
Policy and Analysis: Julie Cayse,
Director, Division of Risk Management,
Office of Examination and Insurance, at
(703) 518–6360; Kathryn Metzker, Loss/
Risk Analyst, Division of Risk
Management, Office of Examination and
Insurance, at (703) 548–2456; Julie
Decker, Loss/Risk Analyst, Division of
Risk Management, Office of
Examination and Insurance, at (703)
518–3684; Aaron Langley, Risk
Management Officer, Division of
Analytics and Surveillance, Office of
Examination and Insurance, at (703)
518–6387; Legal: John Brolin, Staff
Attorney, Office of General Counsel, at
(703) 518–6540; or by mail at National
Credit Union Administration, 1775
Duke Street, Alexandria, VA 22314.
SUPPLEMENTARY INFORMATION:
I. Introduction
The NCUA’s primary mission is to
ensure the safety and soundness of
federally insured credit unions. The
agency performs this function by
examining and supervising all federal
credit unions, participating in the
examination and supervision of
federally insured, state-chartered credit
unions in coordination with state
regulators, and insuring members’
accounts at federally insured credit
unions.1 In its role as administrator of
the NCUSIF, the NCUA insures and
regulates approximately 5,573 federally
insured credit unions, holding total
assets exceeding $1.4 trillion and
representing approximately 111 million
members.2
At its October 2015 meeting, the
Board issued the 2015 Final Rule to
amend Part 702 of the NCUA’s PCA
regulations to require that credit unions
taking certain risks hold capital
commensurate with those risks.3 The
risk-based capital provisions of the 2015
Final Rule apply only to federally
insured, natural-person credit unions
with quarter-end total assets exceeding
$100 million. The overarching intent of
the 2015 Final Rule is to reduce the
likelihood that a relatively small
number of high-risk outlier credit
unions would exhaust their capital and
cause large losses to the NCUSIF. Under
1 As of December 31, 2017, within the nine states
that allow privately insured credit unions,
approximately 116 state-chartered credit unions are
privately insured and are not subject to the NCUA’s
regulation and oversight.
2 Based on December 31, 2017 Call Report Data.
3 80 FR 66625 (Oct. 29, 2015).
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Agencies
[Federal Register Volume 83, Number 153 (Wednesday, August 8, 2018)]
[Proposed Rules]
[Pages 38982-38997]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16863]
========================================================================
Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
========================================================================
Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 /
Proposed Rules
[[Page 38982]]
DEPARTMENT OF ENERGY
10 CFR Part 830
RIN 1992-AA57
Nuclear Safety Management
AGENCY: Office of Environment, Health, Safety and Security, U.S.
Department of Energy.
ACTION: Notice of proposed rulemaking and notice of public meetings.
-----------------------------------------------------------------------
SUMMARY: The Department of Energy (DOE or the Department) publishes a
proposed rule to amend regulations concerning nuclear safety
management. These regulations govern the conduct of DOE contractors,
DOE personnel, and other persons conducting activities (including
providing items and services) that affect, or may affect, the safety of
DOE nuclear facilities. The proposed revisions reflect the experience
gained in the implementation of the regulations over the past seventeen
years, with specific improvements to the process for facility hazard
categorization, the unreviewed safety question process, and the review
and approval of safety documentation. The proposed revisions are
intended to enhance operational efficiency while maintaining robust
safety performance.
DATES: Public comment on this proposed rule will be accepted until
October 9, 2018. For dates and more information on the public meetings
for this proposed rulemaking, see SUPPLEMENTARY INFORMATION.
ADDRESSES: You may submit comments, identified by RIN 1992-AA57, by any
of the following methods:
1. Federal eRulemaking Portal: https://www.regulations.gov. Follow
the instructions for submitting comments.
2. Email: [email protected]. Include RIN 1992-AA57 in the
subject line of the email. Please include the full body of your
comments in the text of the message or as an attachment.
3. Mail: U.S. Department of Energy, Office of Nuclear Safety, AU-
30, 1000 Independence Avenue SW, Washington, DC 20585.
Due to potential delays in DOE's receipt and processing of mail
sent through the U.S. Postal Service, we encourage respondents to
submit comments electronically to ensure timely receipt.
FOR FURTHER INFORMATION CONTACT: Mr. Garrett Smith, U.S. Department of
Energy, Office of Nuclear Safety, AU-30, 1000 Independence Avenue SW,
Washington, DC 20585; (301) 903-2996 or [email protected].
SUPPLEMENTARY INFORMATION: Public meetings for this proposed rulemaking
will be held in:
1. Richland, WA at the HAMMER Federal Training Facility, Building
6091, Room 10, 2890 Horn Rapids Road, Richland, WA, on August 16th,
2018.
2. Albuquerque, NM at the Albuquerque Marriott, Sandia Room, 2101
Louisiana Blvd. NE, Albuquerque, NM, on September 6th, 2018.
3. Oak Ridge, TN at the Oak Ridge Associated Universities, Pollard
Technology Conference Center Auditorium, 210 Badger Avenue, Oak Ridge,
TN, on September 25th, 2018.
4. Aiken, SC at the University of South Carolina--Aiken, Business
and Education Building, Room 124, 471 University Parkway, Aiken, SC, on
September 27th, 2018.
All public meetings will be held from 1 p.m. to 4:30 p.m. and from
6 p.m. to 8:30 p.m. local time. Interested persons who wish to speak at
the public meeting should telephone the Office of Nuclear Safety, (301)
903-2996, by 4:30 p.m. Eastern Time on August 13th, 2018 for Richland,
WA, on August 31st, 2018 for Albuquerque, NM, on September 18th, 2018
for Oak Ridge, TN, and on September 20th, 2018 for Aiken, SC. Each
presentation is limited to 20 minutes.
I. Introduction and Background
A. Introduction
B. Procedural History of the Rule
II. Discussion of Proposed Rule
A. Discussion of Key Proposed Changes
B. Proposed Changes in Order of Appearance
III. Public Comment Procedures
A. Written Comments
B. Public Meetings
IV. Regulatory Review
A. Review Under Executive Order 12866
B. Review Under Executive Orders 13771 and 13777
C. Regulatory Flexibility Act
D. Paperwork Reduction Act
E. National Environmental Policy Act
F. Unfunded Mandates Reform Act of 1995
G. Treasury and General Government Appropriations Act, 1999
H. Executive Order 13132
I. Executive Order 12988
J. Treasury and General Government Appropriations Act, 2001
K. Executive Order 13211
V. Approval of the Office of the Secretary
I. Introduction and Background
A. Introduction
Pursuant to the Atomic Energy Act of 1954, as amended (the AEA),
the Department of Energy (DOE or the Department) owns and leases
nuclear and non-nuclear facilities at various locations in the United
States. These facilities are operated either by DOE or by contractors
with DOE oversight. Activities at these facilities include, but are not
limited to: Research, testing, production, disassembly, or transporting
nuclear materials. DOE regulations governing nuclear safety at these
facilities are set forth in the Nuclear Safety Management rule (10 CFR
part 830). The regulations were issued in response to external
assessments from the National Academy of Sciences (NAS), the enactment
of the Price-Anderson Amendments Act of 1988 (PAAA), and DOE efforts to
improve safety at DOE nuclear facilities. Aspects of 10 CFR part 830
were finalized and issued from 1994 to 2001, covering core safety
requirements for quality assurance and facility safety basis. Over the
past 17 years, DOE has gained considerable experience in the
implementation of 10 CFR part 830, and is proposing to modify the
requirements to incorporate that experience and help ensure more
effective safety performance.
B. Procedural History of the Rule
On December 9, 1991, DOE published Procedural Rules for DOE Nuclear
Activities (56 FR 64290) and a Notice of Proposed Rulemaking and Public
Hearing (1991 Notice, 56 FR 64316) to add Parts 820 and 830 to Title 10
of the Code of Federal Regulation (CFR).\1\ Title
[[Page 38983]]
10 CFR part 830 was proposed to establish safety management
requirements for DOE nuclear facilities. DOE issued, as final, the
sections of 10 CFR part 830 related to the initial provisions
(Sec. Sec. 830.1-830.7) and Subpart A--General Provisions, (Sec. Sec.
830.100-830.120) on April 5, 1994 (1994 Notice, 59 FR 15843).
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\1\ The Department proposed 10 CFR part 820 (Part 820),
Procedural Rules for DOE Nuclear Activities, to establish the
procedural requirements for enforcement activities in accordance
with PAAA. On August 17, 1993, the Department issued the Procedural
Regulations for DOE Nuclear Activities in final form as 10 CFR part
820 (58 FR 43680). Part 820 establishes the procedures for DOE
enforcement actions and for issuing civil and criminal penalties for
contractor, subcontractor, and supplier violations of DOE nuclear
safety requirements.
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The Department issued a Notice of Limited Reopening of the Comment
Periods for the remaining topics to be addressed in 10 CFR part 830 on
August 31, 1995, and for a second, unrelated, rule (Reopening Notice,
60 FR 45381).
On October 10, 2000, the Department published an Interim Final Rule
and Opportunity for Public Comment (65 FR 60291) which amended the
nuclear safety regulations to (1) establish and maintain safety bases
for Hazard Category 1, 2, and 3 DOE nuclear facilities and perform work
in accordance with safety bases, and (2) clarify that the quality
assurance work process requirements apply to standards and controls
adopted to meet regulatory or contract requirements that may affect
nuclear safety (Interim Final Rule). The Interim Final Rule was also
issued to provide further opportunity for public comment on the rule.
Following the public comment period, the Department issued a Final
Rule on January 10, 2001 (66 FR 1810).
II. Discussion of Proposed Rule
A. Discussion of Key Proposed Changes
1. DOE Standard 1027--Section 830.202 of the regulations requires
that DOE nuclear facilities be categorized consistent with DOE-STD-
1027-92 (``Hazard Categorization and Accident Analysis Techniques for
compliance with DOE Order 5480.23, Nuclear Safety Analysis Reports,''
Change Notice 1, September 1997). The Department continues to believe
that the methodology in DOE-STD-1027-92 Ch 1 is sufficient and supports
the categorization of DOE nuclear facilities. In 2001, when Subpart B
of 10 CFR part 830 was issued, not every Hazard Category 1, 2, and 3
DOE nuclear facility was categorized using a standardized methodology,
and therefore consistent application of the cited reference, without
change, was appropriate.
DOE now proposes, after two decades of experience in facility
categorization using DOE-STD-1027-92, Ch 1, to amend Sec.
830.202(b)(3) by adding ``or successor document''. This change would
allow the Department to revise the standard to include up-to-date
research, data, and DOE experience with implementation. This would be
consistent with DOE's practice to periodically evaluate and revise DOE
Technical Standards and would follow the development, review, and
approval process described in DOE Order 252.1A, Technical Standards
Program. The Technical Standards Program process requires concurrence
from all affected Departmental elements prior to issuance of any
standard.
DOE also proposes to amend Section C, Scope, of Appendix A to
remove the reference to the specific version of DOE-STD-1027, for
consistency with the revision in Sec. 830.202. DOE would also remove
Table 1 of Appendix A and replace that table with a definition for
Hazard Category 1, 2, and 3 DOE nuclear facilities in Sec. 830.3 that
references DOE-STD-1027-92 or successor document. The removal of Table
1 would allow successor revisions to more clearly link the
determination of Hazard Category 1, 2, 3, and below hazard category 3
to the methodology in the Standard. The concept that Hazard Category 1
will have higher potential consequences and Hazard Category 3 will have
lower potential consequences will be maintained throughout all
successor documents of DOE-STD-1027.
2. Unreviewed Safety Question (USQ) Process--A situation or
potential situation outside the bounds of the current safety analysis
for a Hazard Category 1, 2, or 3 nuclear facility (as documented in its
approved safety analysis) constitutes an Unreviewed Safety Question
under the current regulations. Section 830.203 allows contractors to
make changes to the facility, to change site or facility procedures,
and to conduct tests and/or experiments without prior DOE approval when
these activities do not involve an Unreviewed Safety Question and do
not require any change to Technical Safety Requirements.
The proposed change to Appendix A to Subpart B of 10 CFR part 830--
General Statement of Safety Basis Policy, H, Unreviewed Safety
Questions, would add the sentence, ``The contractor is allowed to make
editorial and format changes to its USQ procedure while maintaining DOE
approval.'' This proposal would focus the requirement to obtain DOE's
approval on changes with the potential to impact on the safety basis of
the facility.
DOE also proposes to modify Sec. 830.3, Definitions, by changing
the definition for Unreviewed Safety Question (USQ). The current
definition includes four situations that define a USQ: (1) The
probability of the occurrence or the consequences of an accident or the
malfunction of equipment important to safety previously evaluated in
the documented safety analysis (DSA) could be increased; (2) The
possibility of an accident or malfunction of a different type than any
evaluated previously in the documented safety analysis could be
created; or (3) A margin of safety could be reduced; or (4) The
documented safety analysis may not be bounding or may be otherwise
inadequate. As explained in the following paragraphs, the proposed
definition would remove the third situation: ``A margin of safety could
be reduced''.
The current set of four situations that define an USQ in 10 CFR
830.3 reflected standard nuclear industry practice and was an
adaptation of 10 CFR 50.59, changes, tests and experiments, used by the
United States Nuclear Regulatory Commission (NRC). The NRC, in 1968,
added to Sec. 50.59 the concept of ``margin of safety as defined in
the basis for any technical specification is reduced.'' In issuing 10
CFR part 830, DOE modified this question to simply read ``A margin of
safety could be reduced''. In addition to adapting the NRC process, DOE
included the situation of ``(4) The documented safety analysis may not
be bounding or may otherwise be inadequate.''
The NRC, after 30 years of experience implementing Sec. 50.59,
issued an October 21, 1998, Notice of Proposed Rulemaking to change the
criteria associated with margin of safety, explaining that ``the
phrases `margin of safety' and `as defined in the basis for any
technical specification' in the third criterion have been the subject
of differing interpretations because the rule does not define what
constitutes a margin of safety or a basis for any technical
specification in the context of Sec. Sec. 50.59 and 72.48. In
addition, some have questioned the need for the third criterion on
`margin of safety.' '' The third criterion refers to the existence of
two prior questions associated with creation, consequences, and
likelihood of accidents and equipment malfunction. The revision to 10
CFR part 50 removing the term ``margin of safety'' from 10 CFR 50.59
was issued as a final rule on October 4, 1999.
DOE's experience with the margin of safety criteria is similar to
that expressed by the NRC in its rulemaking, specifically, that the
other existing criteria provide sufficient guidance to identify
facility and safety basis changes that warrant DOE approval. Feedback
from periodic surveys considering a broad-range of USQ determinations
indicated that the ``margin of safety''
[[Page 38984]]
criterion has not provided benefit independent of the criteria DOE is
retaining in the definition of the USQ process. In addition,
stakeholder feedback noted that the ``margin of safety'' criterion was
subjectively interpreted and often diverted safety resources without a
corresponding safety benefit. Therefore, the proposed removal of the
criterion related to ``margin of safety'' would enhance DOE and
contractor operational effectiveness, without reducing the level of
safety provided by the current practice. The current practice allows
contractors to conduct certain specified activities without prior DOE
approval, when these activities do not cause an Unreviewed Safety
Question (and when they do not require Technical Safety Requirements
changes).\2\
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\2\ DOE's implementation guidance associated with these criteria
is DOE G 424.1-1B Chg 2, Implementation Guide for Use in Addressing
Unreviewed Safety Question Requirements. Based on the four criteria
defining a situation involving a USQ in 10 CFR part 830, DOE G
424.1-1B Chg 2 contains seven questions. The last question related
to the concept of the margin of safety. If DOE adopts this proposal
in a final rule, DOE would also conduct a process to consider
removal of the question from the DOE Guide.
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3. DOE Approval of Annual DSA Updates--As stated above, DOE
currently requires the contractor, in Sec. 830.203, Unreviewed Safety
Question process, to obtain DOE approval prior to taking any action
determined to involve a USQ. Additionally, in Sec. 830.202 Safety
basis, DOE requires the contractor to annually submit to DOE either the
updated DSA for approval or a letter stating that there have been no
changes in the DSA since the prior submission. This effectively
requires the contractor to submit changes to the DSA for DOE approval
twice. Currently, DOE provides implementation guidance for this
approval process in DOE-STD-1104-2016, Review and Approval of Nuclear
Facility Safety Basis and Safety Design Basis Documents, Section 7.1.2,
Review of Safety Basis Changes and DSA Annual Updates. The guidance
states that ``Review and approval of revisions and annual updates are a
matter of endorsing the incorporation of changes in the safety basis
since the last approval rather than performing a new assessment of the
previously approved safety basis documents.'' While the guidance is
clear in the intent to drive focus of DOE's approval to the change
identified in the USQ process, the regulations' additional requirement
for a second approval has led to considerable implementation
challenges, and unnecessary review iterations without providing
additional safety benefit.
Therefore, DOE is proposing to change the requirement in Sec.
830.202, Safety basis, to require the current DSA be provided to DOE
annually, but not to require DOE approval at that time. Additional
guidance would also be included in Appendix A to Subpart B of 10 CFR
part 830--General Statement of Safety Basis Policy, F, Documented
Safety Analysis, to make clear that DOE's review and approval of the
safety analysis is intended to be focused on changes submitted through
the USQ process, but may require DOE approval if DOE has reason to
believe a portion of the safety basis has substantially changed. DOE
would continue to have the authority to review the safety basis at any
time. DOE would maintain the ability to direct the contractor to
incorporate in the safety basis any changes, conditions, or hazard
controls.
4. Definition and Application of New Facilities, Major
Modification, Preliminary Documented Safety Analysis, and Existing
Facilities--The current definitions of a New DOE nuclear facility,
Major Modification, Preliminary documented safety analysis, and
Existing DOE nuclear facility (and applications of those definitions
within the rule) reference specific dates related to the issuance of
the rule and the need to bring DOE nuclear facilities into the
regulatory framework. DOE is proposing to change the definitions to
clearly recognize that all current DOE nuclear facilities are already
within this regulatory framework and that new DOE nuclear facilities
would be those that are in design or under construction that do not yet
have a DOE approved safety basis. Additionally, the specific definition
of an existing DOE nuclear facility is being proposed to be deleted.
DOE proposes instead to rely upon a new definition of Hazard Category
1, 2, and 3 DOE nuclear facilities and the specific endpoint of a DOE
approved safety basis to delineate between a new facility and an
existing facility.
DOE also proposes to change the definition of a Major modification
to remove the completion date of the facility. The definition would
rely upon a criteria of a substantial change to the existing safety
basis for the facility. This would link the meaning of ``Major
modification'' to changes to existing Hazard Category 1, 2, or 3
nuclear facilities via the existence of a safety basis for the
facility. Furthermore, additional clarity is proposed within 10 CFR
part 830, subpart B, to highlight that the concept of ``Major
modification'' would only apply to existing Hazard Category 1, 2, or 3
DOE nuclear facilities (i.e., nuclear facilities with an approved
safety basis).
DOE proposes to change the definition of Preliminary documented
safety analysis to maintain consistency with other proposed changes to
the definitions related to nuclear facilities.
B. Proposed Changes in Order of Appearance
The specific proposed changes to 10 CFR part 830 are summarized
below in the order in which they appear:
1. In proposed Sec. 830.3 ``Definitions,'' the current definition
for Existing DOE nuclear facility would be deleted, a definition for
Hazard Category 1, 2, and 3 DOE nuclear facilities has been proposed,
and there would be a modification of the current definition of New
Hazard Category 1, 2, and 3 DOE nuclear facility. These changes are
designed to improve the delineation between new and existing
facilities. The definition for Major modification would be changed to
remove the effective date associated with the original issuance of the
rule. The definition for Preliminary documented safety analysis would
be changed to better reflect the intent of preliminary documented
safety analysis being associated with Hazard Category 1, 2, or 3 DOE
nuclear facilities rather than all DOE nuclear facilities. The
definition for Safety management system would be changed to include the
specific title of 48 CFR 970.5223-1, Integration of environment,
safety, and health into work planning and execution. The definition for
Unreviewed Safety Question (USQ) would be changed by adding ``or'' to
the end of (2), deleting ``(3) A margin of safety could be reduced;
or'', and renumbering (4) as (3).
2. In proposed Sec. 830.201 ``Performance of Work,'' current Sec.
830.201 would be changed by adding ``DOE-approved'' to modify safety
basis to maintain consistency with Sec. 830.207, DOE approval of
safety basis.
3. Proposed Sec. 830.202(b)(3) would be changed to add ``or
successor document'' to modify DOE-STD-1027-92 (``Hazard Categorization
and Accident Analysis Techniques for compliance with DOE Order 5480.23,
Nuclear Safety Analysis Reports,'' Change Notice 1, September 1997).
This proposed change would allow DOE to modify the methodology used to
perform hazard categorization consistent with DOE's policy of
maintaining technical standards to reflect updated knowledge and
methods. Current Sec. 830.202(c)(2) would be changed to read, ``(2)
Annually provide DOE the current documented safety analysis or a letter
stating that
[[Page 38985]]
there have been no changes in the documented safety analysis since the
prior submittal; and''. These proposed changes reflect the removal of
the requirement for DOE to annually approve the documented safety
analysis, and are intended to focus DOE's approval on the existing
requirement to approve changes through the USQ process.
4. In proposed Sec. 830.203 ``Unreviewed safety question
process,'' current Sec. 830.203(a) would be changed by adding ``DOE-
approved'' as a modifier to USQ, and by changing the word ``process''
to ``procedure''. These proposed changes are to clarify the connection
between references to the DOE-approved procedure in proposed Sec.
830.203(a), Sec. 830.203(b), and Sec. 830.203(c). Current Sec.
830.203(b) would be deleted, since DOE no longer has existing
facilities operating outside of 10 CFR part 830. In the current Sec.
830.203(c), which is proposed to be redesignated as Sec. 830.203(b),
the word ``new'' has been proposed to be moved to match a proposed
change in the definition of New Hazard Category 1, 2, and 3 nuclear
facility, and ``207(d)'' would be changed to ``207(a)'' to reflect
changes to Sec. 830.207. Current Sec. 830.203(d) would be
redesignated as Sec. 830.203(c). Current Sec. 830.203(e) would be
redesignated as Sec. 830.203(d). Current Sec. 830.203(f) would be
redesignated as Sec. 830.203(e), ``submit'' would be replaced by
``provide'', and ``submissions'' would be replaced by ``submittal'' to
better reflect that the document is being given to DOE for review, but
not for approval. Current Sec. 830.203(g) would be redesignated as
Sec. 830.203(f), and the text would be changed to read ``initiated to
meet paragraph (f)(1) of this section'' consistent with citation
changes in this section.
5. In proposed Sec. 830.204 ``Documented safety analysis,''
current Sec. 830.204(a) would be updated by changing ``Table 2'' to
``Table 1'' to reflect the deletion of Table 1 and re-numbering of
subsequent tables.
6. In proposed Sec. 830.206 ``Preliminary documented safety
analysis,'' current Sec. 830.206 would be changed to read ``Prior to
construction of a new Hazard Category 1, 2, or 3 DOE nuclear facility
or a major modification to an existing Hazard Category 1, 2, or 3 DOE
nuclear facility, the contractor responsible for the design and
construction of the new facility or major modification must:'' To
reflect changes to the definitions in Sec. 830.3. Current Sec.
830.206(b)(1) would be changed to add, ``, or successor document'' as a
modifier to ``DOE Order 420.1, Facility Safety'' to reflect the ongoing
updates to the current version of the DOE order.
7. In proposed Sec. 830.207 ``DOE approval of safety basis,''
current Sec. 830.207(a) would be deleted, as DOE no longer has
existing Hazard Category 1, 2, or 3 facilities operated outside of 10
CFR part 830. Current Sec. 830.207(b) would be changed by adding
``updated or amended'' to modify ``safety basis'', moving the word
``existing'' to before the phrase ``Hazard Category 1, 2, or 3 DOE
nuclear facility'' to better match the revised definition, and by
deleting ``in effect on October 10, 2000, or as approved by DOE at a
later date'' to reflect that all Hazard Category 1, 2, or 3 DOE nuclear
facilities already operate within 10 CFR part 830. Current Sec.
830.207(c) would be deleted, as DOE no longer has existing Hazard
Category 1, 2, or 3 facilities operated outside of 10 CFR part 830.
Current Sec. 830.207(d) would be redesignated as Sec. 830.207(a) and
updated to reflect the changes in definitions in Sec. 830.3. As a
result, the proposed Sec. 830.207(a) would now read as: ``With respect
to a new Hazard Category 1, 2, or 3 DOE nuclear facility or a major
modification to an existing Hazard Category 1, 2, or 3 DOE nuclear
facility, a contractor may not begin operation of the facility or
modification prior to the issuance of a safety evaluation report in
which DOE approves the safety basis for the facility or modification.''
8. In proposed Appendix A to Subpart B to 10 CFR part 830--General
Statement of Safety Basis Policy current ``A. Introduction'' would be
modified by replacing a reference to an outdated DOE Policy with a
specific statement that reflects current DOE policy and would now read
as follows, ``This Appendix does not create any new requirements and
should be used consistently with DOE's policy that work be conducted
safely and efficiently and in a manner that ensures protection of
workers, the public, and the environment.''
9. In proposed Appendix A to Subpart B to 10 CFR part 830--General
Statement of Safety Basis Policy current ``C. Scope, 1.'' would be
changed by replacing the reference to ``DOE-STD-1027-92 Change Notice
1, September 1997'' with a general reference to DOE-STD-1027 to reflect
the proposed change to allow successor versions of DOE-STD-1027 to be
used, the reference to ``Table 1'' would be deleted to reflect the
proposed deletion of Table 1. The proposed sentences now would read,
``A contractor must establish and maintain a safety basis for a Hazard
Category 1, 2, or 3 DOE nuclear facility because these facilities have
the potential for significant radiological consequences. DOE-STD-1027
sets forth the methodology for categorizing a DOE nuclear facility
based on the inventory of radioactive materials.'' Current ``C. Scope,
2.'' Would be changed to delete the parenthetical reference to
``including radiological facilities'', and by adding ``DOE'' to the
reference to Hazard Category 1, 2, and 3 nuclear facilities to match
changes to definitions within Sec. 830.3. Current ``C. Scope'' Table 1
is proposed for deletion for consistency with the proposal to allow use
of subsequent versions of DOE-STD-1027, since Table 1 references the
specific content of DOE-STD-1027-92, Change Notice 1, September 1997.
10. In proposed Appendix A to Subpart B to 10 CFR part 830--General
Statement of Safety Basis Policy, current ``E. Enforcement of Safety
Basis Requirements, 4.'' would be changed by deleting the word
``however'' to improve clarity.
11. In proposed Appendix A to Subpart B to 10 CFR part 830--General
Statement of Safety Basis Policy current ``F. Documented Safety
Analysis, 3.'' would be changed by adding ``as: (1) part of the initial
submittal; (2) when revisions are submitted as part of a positive USQ
or major modification; (3) if DOE has reason to believe a portion of
the safety basis to be inadequate, or; (4) if DOE has reason to believe
a portion of the safety basis has substantially changed. DOE will
review the DSA'' to better define when and why DOE would review a DSA.
This change is proposed to be consistent with proposed changes to DOE's
requirement to annually approve the DSA. Current ``F. Documented Safety
Analysis, 3.'' would also be changed by adding ``in the Safety
Evaluation Report'' to the end of the last sentence in that section,
which currently reads, ``A documented safety analysis must contain any
conditions or changes required by DOE.'' This change is proposed to
clarify how DOE directs conditions and changes required by DOE.
Additionally, Current ``F. Documented Safety Analysis, 3.'' would be
changed by adding the following sentences, ``Generally, DOE's review of
the annual submittal may be limited to ensuring that the results of
USQs have been adequately incorporated into the DSA. If additional
changes are proposed by the contractor and included in the annual
update that have not been previously approved by DOE or have not been
evaluated as a part of the USQ process, DOE must review and approve
these changes. DOE has the authority to review the safety basis at any
time.''
[[Page 38986]]
This proposed change is in support of focusing DOE's approval of
changes in the DSA to the incorporation of USQ's or as DOE determines
are necessary to maintain safe operations, rather than the previous
annual process. Current ``F. Documented Safety Analysis, 4.'' would be
changed by renumbering the reference to ``Table 2'' to ``Table 1'' to
reflect the deletion of Table 1. Current ``F. Documented Safety
Analysis'' would be changed by changing the title of ``Table 2'' to
``Table 1'' to reflect the deletion of Table 1. Current ``F. Documented
Safety Analysis, 5.'' would be changed by renumbering the reference to
``Table 2'' to ``Table 1'' to reflect the deletion of Table 1, by
changing the reference to the definition of nuclear facility to re-
state the existing definition within Sec. 830.3 instead of
paraphrasing the definition, by renumbering the reference to ``Table
3'' to ``Table 2'' to reflect the deletion of Table 1, and by replacing
``specific nuclear facilities'' with ``terms'' in reference to the
content within Table 1. Current ``F. Documented Safety Analysis'' would
be changed by renumbering the title of ``Table 3'' to ``Table 2'' to
reflect the proposed deletion of Table 1 and changing the reference to
``Table 2'' to ``Table 1'' to reflect the proposed deletion of Table 1.
Current ``F. Documented Safety Analysis, 6.'' would be changed to
delete the phrase ``If construction begins after December 11, 2000''
and by adding ``or successor document'' as a modifier to ``DOE Order
420.1, Facility Safety'' to reflect the ongoing updates to the current
version of the DOE order.
12. In proposed Appendix A to Subpart B to 10 CFR part 830--General
Statement of Safety Basis Policy current ``G. Hazard Controls, 2.''
would be changed to add ``or successor document'' as a modifier to
``DOE Order 420.1, Facility Safety'' to reflect the ongoing updates to
the current version of the DOE order. Current ``G. Hazard Controls,
4.'' would be changed to update the reference to DOE Guide 423.1-1B and
by adding, ``or successor document'' to reflect the ongoing updates to
the current version of the DOE guide. Current ``G. Hazard Controls,
4.'' would be changed by changing the reference to ``Table 4'' to
``Table 3'' to reflect the proposed deletion of Table 1. Current ``G.
Hazard Controls'' would be changed by changing the title of the table
from ``Table 4'' to ``Table 3'' to reflect the proposed deletion of
Table 1.
13. In proposed Appendix A to Subpart B to 10 CFR part 830--General
Statement of Safety Basis Policy current ``H. Unreviewed Safety
Questions, 3.'' Would be changed to update the reference to DOE Guide
424.1-1B Chg 2, to update the title of the referenced guide to
``Implementation Guide for Use in Addressing Unreviewed Safety Question
Requirements,'' to add ``or successor document'' to reflect the ongoing
updates to the current version of the DOE guide, and by adding the
sentence, ``The contractor is allowed to make editorial and format
changes to its USQ procedure while maintaining DOE approval.'' The
additional sentence wold be provided to better delineate those aspects
of the USQ process on which DOE approval focuses.
14. Throughout 10 CFR part 830, the term ``Hazard Category'' would
be capitalized to improve consistency with the usage within the DOE
regulatory structure.
III. Public Comment Procedures
A. Written Comments
Interested persons are invited to participate in this proceeding by
submitting data, views, or arguments. Written comments should be
submitted to the address, and in the form, indicated in the ADDRESSES
section of this notice of proposed rulemaking. To help DOE review the
comments, interested persons are asked to refer to specific proposed
rule provisions, if possible.
If you submit information that you believe to be exempt by law from
public disclosure, you should submit one complete copy, as well as one
copy from which the information claimed to be exempt by law from public
disclosure has been deleted. DOE is responsible for the final
determination with regard to disclosure or nondisclosure of the
information and for treating it accordingly under the DOE Freedom of
Information regulations at 10 CFR 1004.11.
B. Public Meetings
Public meetings will be held at the times, dates, and places
indicated at the start of the SUPPLEMENTARY INFORMATION section of this
notice of proposed rulemaking. Any person who is interested in making
an oral presentation should make a phone request to the person and
telephone number in the SUPPLEMENTARY INFORMATION section by 4:30 p.m.
on the date specified for making such requests. The person should
provide a daytime phone number where he or she can be reached. Each
oral presentation will be limited to 20 minutes. Persons making an oral
presentation are requested to bring 3 copies of their prepared
statement to the meeting and submit them to the registration desk prior
to the meeting.
IV. Regulatory Review
A. Review Under Executive Order 12866
This notice of proposed rulemaking has been determined not to be a
significant regulatory action under Executive Order 12866, ``Regulatory
Planning and Review,'' 58 FR 51735 (Oct. 4, 1993). Accordingly, this
notice of proposed rulemaking was not subject to review by the Office
of Information and Regulatory Affairs of the Office of Management and
Budget.
B. Review Under Executive Orders 13771 and 13777
On January 30, 2017, the President issued Executive Order 13771,
``Reducing Regulation and Controlling Regulatory Costs.'' That Order
stated the policy of the executive branch is to be prudent and
financially responsible in the expenditure of funds, from both public
and private sources. The Order stated it is essential to manage the
costs associated with the governmental imposition of private
expenditures required to comply with Federal regulations. This proposed
rule is expected to be an E.O. 13771 deregulatory action.
Additionally, on February 24, 2017, the President issued Executive
Order 13777, ``Enforcing the Regulatory Reform Agenda.'' The Order
required the head of each agency designate an agency official as its
Regulatory Reform Officer (RRO). Each RRO oversees the implementation
of regulatory reform initiatives and policies to ensure that agencies
effectively carry out regulatory reforms, consistent with applicable
law. Further, E.O. 13777 requires the establishment of a regulatory
task force at each agency. The regulatory task force is required to
make recommendations to the agency head regarding the repeal,
replacement, or modification of existing regulations, consistent with
applicable law. At a minimum, each regulatory reform task force must
attempt to identify regulations that:
(i) Eliminate jobs, or inhibit job creation;
(ii) Are outdated, unnecessary, or ineffective;
(iii) Impose costs that exceed benefits;
(iv) Create a serious inconsistency or otherwise interfere with
regulatory reform initiatives and policies;
(v) Are inconsistent with the requirements of Information Quality
Act, or the guidance issued pursuant to that Act, in particular those
regulations that rely in whole or in part on data, information, or
methods that are not
[[Page 38987]]
publicly available or that are insufficiently transparent to meet the
standard for reproducibility; or
(vi) Derive from or implement Executive Orders or other
Presidential directives that have been subsequently rescinded or
substantially modified.
DOE concludes that this final rule is consistent with the
directives set forth in these executive orders. This provisions in this
proposed rule are intended, as described in section II, to enhance
operational efficiency while maintaining robust safety performance at
DOE nuclear facilities.
C. Regulatory Flexibility Act
The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) requires
preparation of an initial regulatory flexibility analysis for any rule
that by law must be proposed for public comment, unless the agency
certifies that the rule, if promulgated, will not have a significant
economic impact on a substantial number of small entities. As required
by Executive Order 13272, ``Proper Consideration of Small Entities in
Agency Rulemaking,'' 67 FR 53461 (Aug. 16, 2002), DOE published
procedures and policies on February 19, 2003, to ensure that the
potential impacts of its rules on small entities are properly
considered during the rulemaking process. 68 FR 7990. DOE has made its
procedures and policies available on the Office of the General
Counsel's website (https://energy.gov/gc/office-general-counsel).
DOE has reviewed this proposed rule under the provisions of the
Regulatory Flexibility Act and the procedures and policies published on
February 19, 2003. The proposed rule would incorporate the experience
of more than a decade of implementation to improve the effectiveness of
the DOE nuclear safety regulatory framework while maintaining safety
performance. Requirements that are considered duplicative or of little
value have been proposed to be removed. DOE is proposing four key
changes in this proposed rule, as described in II. Discussion of
Proposed Rule, A. Discussion of Key Proposed Changes.
The changes in this proposed rule are all expected to reduce burden
on affected DOE contractors. On this basis, DOE certifies that this
proposed rule would not have a significant economic impact on a
substantial number of small entities. Accordingly, DOE has not prepared
a regulatory flexibility analysis for this rulemaking. DOE's
certification and supporting statement of factual basis will be
provided to the Chief Counsel for Advocacy of the Small Business
Administration pursuant to 5 U.S.C. 605(b).
D. Paperwork Reduction Act
The information collection necessary to administer DOE's nuclear
safety program under 10 CFR part 830 is subject to OMB approval under
the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. The information
collection provisions of this rule are not substantially different from
those contained in DOE contracts with DOE prime contractors covered by
this rule and were previously approved by the Office of Management and
Budget (OMB) and under OMB Control No. 1910-0300. Public reporting
burden for the certification is estimated to average 1.91 hours per
response, including the time for reviewing instructions, searching
existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information.
Notwithstanding any other provision of the law, no person is
required to respond to, nor shall any person be subject to a penalty
for failure to comply with, a collection of information subject to the
requirements of the PRA, unless that collection of information displays
a currently valid OMB Control Number.
E. National Environmental Policy Act
DOE has determined that this proposed rule is covered under the
Categorical Exclusion in DOE's National Environmental Policy Act
regulations at paragraph A.5 of Appendix A to Subpart D, 10 CFR part
1021, which applies to rulemaking that interprets or amends an existing
rule or regulation without changing the environmental effect of the
rule or regulation that is being amended. The proposed rule would amend
DOE's regulations by removing duplicative approval requirements,
updating definitions, and increasing the efficiency of internal
processes. These proposed amendments are primarily procedural and would
not change the environmental effect of 10 CFR part 830. Accordingly,
neither an environmental assessment nor an environmental impact
statement is required.
F. Unfunded Mandates Reform Act of 1995
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA)
requires each Federal agency to assess the effects of Federal
regulatory actions on State, local, and Tribal governments and the
private sector. Public Law 104-4, sec. 201 (codified at 2 U.S.C. 1531).
For regulatory actions likely to result in a rule that may cause the
expenditure by State, local, and Tribal governments, in the aggregate,
or by the private sector of $100 million or more in any one year
(adjusted annually for inflation), section 202 of UMRA requires a
Federal agency to publish a written statement that estimates the
resulting costs, benefits, and other effects on the national economy.
(2 U.S.C. 1532(a), (b)) UMRA also requires a Federal agency to develop
an effective process to permit timely input by elected officers of
State, local, and Tribal governments on a ``significant
intergovernmental mandate,'' and requires an agency plan for giving
notice and opportunity for timely input to potentially affected small
governments before establishing any requirements that might
significantly or uniquely affect them. On March 18, 1997, DOE published
a statement of policy on its process for intergovernmental consultation
under UMRA. 62 FR 12820. (This policy is also available at https://energy.gov/gc/office-general-counsel.) DOE examined this proposed rule
according to UMRA and its statement of policy and has tentatively
determined that the rule contains neither an intergovernmental mandate,
nor a mandate that may result in the expenditure by State, local, and
Tribal government, in the aggregate, or by the private sector, of $100
million or more in any year. Accordingly, no further assessment or
analysis is required under UMRA.
G. Treasury and General Government Appropriations Act, 1999
Section 654 of the Treasury and General Government Appropriations
Act, 1999, 5 U.S.C. 601 note, requires Federal agencies to issue a
Family Policymaking Assessment for any proposed rule that may affect
family wellbeing. While this proposed rule would apply to individuals
who may be members of a family, the rule would not have any impact on
the autonomy or integrity of the family as an institution. Accordingly,
DOE has concluded that it is not necessary to prepare a Family
Policymaking Assessment.
H. Executive Order 13132
Executive Order 13132, ``Federalism,'' 64 FR 43255 (Aug. 4, 1999),
imposes certain requirements on agencies formulating and implementing
policies or regulations that preempt State law or that have federalism
implications. Agencies are required to examine the constitutional and
statutory authority supporting any action that would limit the
policymaking discretion of the States and carefully assess the
necessity for such actions. DOE has examined this proposed rule and has
determined that it would not preempt State law and
[[Page 38988]]
would not have a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. No further action is required by Executive Order 13132.
I. Executive Order 12988
With respect to the review of existing regulations and the
promulgation of new regulations, section 3(a) of Executive Order 12988,
``Civil Justice Reform,'' 61 FR 4729 (Feb. 7, 1996), imposes on
Executive agencies the general duty to adhere to the following
requirements: (1) Eliminate drafting errors and ambiguity; (2) write
regulations to minimize litigation; and (3) provide a clear legal
standard for affected conduct rather than a general standard and
promote simplification and burden reduction. With regard to the review
required by section 3(a), section 3(b) of Executive Order 12988
specifically requires that Executive agencies make every reasonable
effort to ensure that the regulation: (1) Clearly specifies the
preemptive effect, if any; (2) clearly specifies any effect on existing
Federal law or regulation; (3) provides a clear legal standard for
affected conduct while promoting simplification and burden reduction;
(4) specifies the retroactive effect, if any; (5) adequately defines
key terms; and (6) addresses other important issues affecting clarity
and general draftsmanship under any guidelines issued by the Attorney
General. Section 3(c) of Executive Order 12988 requires Executive
agencies to review regulations in light of applicable standards in
section 3(a) and section 3(b) to determine whether they are met or it
is unreasonable to meet one or more of them. DOE has completed the
required review and determined that, to the extent permitted by law,
this proposed rule meets the relevant standards of Executive Order
12988.
J. Treasury and General Government Appropriations Act, 2001
The Treasury and General Government Appropriations Act, 2001, 44
U.S.C. 3516 note, provides for agencies to review most disseminations
of information to the public under guidelines established by each
agency pursuant to general guidelines issued by OMB. OMB's guidelines
were published at 67 FR 8452 (Feb. 22, 2002), and DOE's guidelines were
published at 67 FR 62446 (Oct. 7, 2002). DOE has reviewed this proposed
rule under the OMB and DOE guidelines and has concluded that it is
consistent with applicable policies in those guidelines.
K. Executive Order 13211
Executive Order 13211, ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use,'' 66 FR 28355
(May 22, 2001), requires Federal agencies to prepare and submit to the
Office of Information and Regulatory Affairs (OIRA) a Statement of
Energy Effects for any proposed significant energy action. A
``significant energy action'' is defined as any action by an agency
that promulgated or is expected to lead to promulgation of a final
rule, and that: (1) Is a significant regulatory action under Executive
Order 12866, or any successor order; and (2) is likely to have a
significant adverse effect on the supply, distribution, or use of
energy, or (3) is designated by the Administrator of OIRA as a
significant energy action. For any proposed significant energy action,
the agency must give a detailed statement of any adverse effects on
energy supply, distribution, or use should the proposal be implemented,
and of reasonable alternatives to the action and their expected
benefits on energy supply, distribution, and use. This regulatory
action has been determined to not be a significant regulatory action,
and it would not have an adverse effect on the supply, distribution, or
use of energy. Thus, this action is not a significant energy action.
Accordingly, DOE has not prepared a Statement of Energy Effects.
V. Approval of the Office of the Secretary
The Secretary of Energy has approved the publication of this
proposed rule.
List of Subjects in 10 CFR Part 830
Administrative practice and procedure, DOE contracts, Environment,
Federal buildings and facilities, Government contracts, Nuclear
materials, Nuclear power plants and reactors, Nuclear safety,
Penalties, Public health, Reporting and recordkeeping requirements, and
Safety.
Issued in Washington, DC, on August 1, 2018.
Dan Brouillette,
Deputy Secretary of Energy.
For the reasons stated in the preamble, DOE proposes to revise 10
CFR part 830 to read as follows:
PART 830--NUCLEAR SAFETY MANAGEMENT
Sec.
830.1 Scope.
830.2 Exclusions.
830.3 Definitions.
830.4 General requirements.
830.5 Enforcement.
830.6 Recordkeeping.
830.7 Graded approach.
Subpart A--Quality Assurance Requirements
830.120 Scope.
830.121 Quality Assurance Program (QAP).
830.122 Quality assurance criteria.
Subpart B--Safety Basis Requirements
830.200 Scope.
830.201 Performance of work.
830.202 Safety basis.
830.203 Unreviewed safety question process.
830.204 Documented safety analysis.
830.205 Technical safety requirements.
830.206 Preliminary documented safety analysis.
830.207 DOE approval of safety basis.
Appendix A to Subpart B to Part 830--General Statement of Safety
Basis Policy
Authority: 42 U.S.C. 2201; 42 U.S.C. 7101 et seq.; and 50 U.S.C.
2401 et seq.
Sec. 830.1 Scope.
This part governs the conduct of DOE contractors, DOE personnel,
and other persons conducting activities (including providing items and
services) that affect, or may affect, the safety of DOE nuclear
facilities.
Sec. 830.2 Exclusions.
This part does not apply to:
(a) Activities that are regulated through a license by the Nuclear
Regulatory Commission (NRC) or a State under an Agreement with the NRC,
including activities certified by the NRC under section 1701 of the
Atomic Energy Act (Act);
(b) Activities conducted under the authority of the Director, Naval
Nuclear Propulsion, pursuant to Executive Order 12344, as set forth in
Public Law 106-65;
(c) Transportation activities which are regulated by the Department
of Transportation;
(d) Activities conducted under the Nuclear Waste Policy Act of
1982, as amended, and any facility identified under section 202(5) of
the Energy Reorganization Act of 1974, as amended; and
(e) Activities related to the launch approval and actual launch of
nuclear energy systems into space.
Sec. 830.3 Definitions.
(a) The following definitions apply to this part:
Administrative controls means the provisions relating to
organization and management, procedures, recordkeeping, assessment, and
reporting necessary to ensure safe operation of a facility.
[[Page 38989]]
Bases appendix means an appendix that describes the basis of the
limits and other requirements in technical safety requirements.
Critical assembly means special nuclear devices designed and used
to sustain nuclear reactions, which may be subject to frequent core and
lattice configuration change and which frequently may be used as
mockups of reactor configurations.
Criticality means the condition in which a nuclear fission chain
reaction becomes self-sustaining.
Design features means the design features of a nuclear facility
specified in the technical safety requirements that, if altered or
modified, would have a significant effect on safe operation.
Document means recorded information that describes, specifies,
reports, certifies, requires, or provides data or results.
Documented safety analysis means a documented analysis of the
extent to which a nuclear facility can be operated safely with respect
to workers, the public, and the environment, including a description of
the conditions, safe boundaries, and hazard controls that provide the
basis for ensuring safety.
Environmental restoration activities means the process(es) by which
contaminated sites and facilities are identified and characterized and
by which contamination is contained, treated, or removed and disposed.
Fissionable materials means a nuclide capable of sustaining a
neutron-induced chain reaction (e.g., uranium-233, uranium-235,
plutonium-238, plutonium-239, plutonium-241, neptunium-237, americium-
241, and curium-244).
Graded approach means the process of ensuring that the level of
analysis, documentation, and actions used to comply with a requirement
in this part are commensurate with:
(i) The relative importance to safety, safeguards, and security;
(ii) The magnitude of any hazard involved;
(iii) The life cycle stage of a facility;
(iv) The programmatic mission of a facility;
(v) The particular characteristics of a facility;
(vi) The relative importance of radiological and nonradiological
hazards; and
(vii) Any other relevant factor.
Hazard means a source of danger (i.e., material, energy source, or
operation) with the potential to cause illness, injury, or death to a
person or damage to a facility or to the environment (without regard to
the likelihood or credibility of accident scenarios or consequence
mitigation).
Hazard Category 1, 2, and 3 DOE nuclear facilities means nuclear
facilities that meet the criteria for their respective hazard category
consistent with the provisions of DOE-STD-1027-92, Change Notice 1, or
successor document. Hazard Category 1, 2, and 3 DOE nuclear facilities
are required to have safety bases established in accordance with
Subpart B of this part. Hazard categories are based on their
radioactive material inventories and the potential consequences to the
public, workers, and the environment. Hazard Category 1 represents the
highest potential consequence and Hazard Category 3 represents the
lowest potential consequence of the facilities required to establish
safety bases.
Hazard controls means measures to eliminate, limit, or mitigate
hazards to workers, the public, or the environment, including
(i) Physical, design, structural, and engineering features;
(ii) Safety structures, systems, and components;
(iii) Safety management programs;
(iv) Technical safety requirements; and
(v) Other controls necessary to provide adequate protection from
hazards.
Item is an all-inclusive term used in place of any of the
following: Appurtenance, assembly, component, equipment, material,
module, part, product, structure, subassembly, subsystem, system, unit,
or support systems.
Limiting conditions for operation means the limits that represent
the lowest functional capability or performance level of safety
structures, systems, and components required for safe operations.
Limiting control settings means the settings on safety systems that
control process variables to prevent exceeding a safety limit.
Low-level residual fixed radioactivity means the remaining
radioactivity following reasonable efforts to remove radioactive
systems, components, and stored materials. The remaining radioactivity
is composed of surface contamination that is fixed following chemical
cleaning or some similar process; a component of surface contamination
that can be picked up by smears; or activated materials within
structures. The radioactivity can be characterized as low-level if the
smearable radioactivity is less than the values defined for removable
contamination by 10 CFR part 835, Appendix D, Surface Contamination
Values, and the hazard analysis results show that no credible accident
scenario or work practices would release the remaining fixed
radioactivity or activation components at levels that would prudently
require the use of active safety systems, structures, or components to
prevent or mitigate a release of radioactive materials.
Major modification means a modification to a DOE nuclear facility
that substantially changes the existing safety basis for the facility.
New Hazard Category 1, 2, and 3 DOE nuclear facility means a Hazard
Category 1, 2, or 3 DOE nuclear facility that is in design or under
construction that does not yet have a DOE approved safety basis.
Nonreactor nuclear facility means those facilities, activities or
operations that involve, or will involve, radioactive and/or
fissionable materials in such form and quantity that a nuclear or a
nuclear explosive hazard potentially exists to workers, the public, or
the environment, but does not include accelerators and their operations
and does not include activities involving only incidental use and
generation of radioactive materials or radiation such as check and
calibration sources, use of radioactive sources in research and
experimental and analytical laboratory activities, electron
microscopes, and X- ray machines.
Nuclear facility means a reactor or a nonreactor nuclear facility
where an activity is conducted for or on behalf of DOE and includes any
related area, structure, facility, or activity to the extent necessary
to ensure proper implementation of the requirements established by this
Part.
Operating limits means those limits required to ensure the safe
operation of a nuclear facility, including limiting control settings
and limiting conditions for operation.
Preliminary documented safety analysis means documentation prepared
in connection with the design and construction of a new Hazard Category
1, 2, or 3 DOE nuclear facility or a major modification to an existing
Hazard Category 1, 2, or 3 DOE nuclear facility that provides a
reasonable basis for the preliminary conclusion that the nuclear
facility can be operated safely through the consideration of factors
such as:
(i) The nuclear safety design criteria to be satisfied;
(ii) A safety analysis that derives aspects of design that are
necessary to satisfy the nuclear safety design criteria; and
(iii) An initial listing of the safety management programs that
must be developed to address operational safety considerations.
[[Page 38990]]
Process means a series of actions that achieves an end or result.
Quality means the condition achieved when an item, service, or
process meets or exceeds the user's requirements and expectations.
Quality assurance means all those actions that provide confidence
that quality is achieved.
Quality Assurance Program (QAP) means the overall program or
management system established to assign responsibilities and
authorities, define policies and requirements, and provide for the
performance and assessment of work.
Reactor means any apparatus that is designed or used to sustain
nuclear chain reactions in a controlled manner such as research, test,
and power reactors, and critical and pulsed assemblies and any assembly
that is designed to perform subcritical experiments that could
potentially reach criticality; and, unless modified by words such as
containment, vessel, or core, refers to the entire facility, including
the housing, equipment and associated areas devoted to the operation
and maintenance of one or more reactor cores.
Record means a completed document or other media that provides
objective evidence of an item, service, or process.
Safety basis means the documented safety analysis and hazard
controls that provide reasonable assurance that a DOE nuclear facility
can be operated safely in a manner that adequately protects workers,
the public, and the environment.
Safety class structures, systems, and components means the
structures, systems, or components, including portions of process
systems, whose preventive or mitigative function is necessary to limit
radioactive hazardous material exposure to the public, as determined
from safety analyses.
Safety evaluation report means the report prepared by DOE to
document:
(i) The sufficiency of the documented safety analysis for a Hazard
Category 1, 2, or 3 DOE nuclear facility;
(ii) The extent to which a contractor has satisfied the
requirements of Subpart B of this part; and
(iii) The basis for approval by DOE of the safety basis for the
facility, including any conditions for approval.
Safety limits means the limits on process variables associated with
those safety class physical barriers, generally passive, that are
necessary for the intended facility function and that are required to
guard against the uncontrolled release of radioactive materials.
Safety management program means a program designed to ensure a
facility is operated in a manner that adequately protects workers, the
public, and the environment by covering a topic such as: Quality
assurance; maintenance of safety systems; personnel training; conduct
of operations; inadvertent criticality protection; emergency
preparedness; fire protection; waste management; or radiological
protection of workers, the public, and the environment.
Safety management system means an integrated safety management
system established consistent with 48 CFR 970.5223-1, Integration of
environment, safety, and health into work planning and execution.
Safety significant structures, systems, and components means the
structures, systems, and components which are not designated as safety
class structures, systems, and components, but whose preventive or
mitigative function is a major contributor to defense in depth and/or
worker safety as determined from safety analyses.
Safety structures, systems, and components means both safety class
structures, systems, and components and safety significant structures,
systems, and components.
Service means the performance of work, such as design,
manufacturing, construction, fabrication, assembly, decontamination,
environmental restoration, waste management, laboratory sample
analyses, inspection, nondestructive examination/testing, environmental
qualification, equipment qualification, repair, installation, or the
like.
Surveillance requirements means requirements relating to test,
calibration, or inspection to ensure that the necessary operability and
quality of safety structures, systems, and components and their support
systems required for safe operations are maintained, that facility
operation is within safety limits, and that limiting control settings
and limiting conditions for operation are met.
Technical safety requirements (TSRs) means the limits, controls,
and related actions that establish the specific parameters and
requisite actions for the safe operation of a nuclear facility and
include, as appropriate for the work and the hazards identified in the
documented safety analysis for the facility: Safety limits, operating
limits, surveillance requirements, administrative and management
controls, use and application provisions, and design features, as well
as a bases appendix.
Unreviewed Safety Question (USQ) means a situation where:
(i) The probability of the occurrence or the consequences of an
accident or the malfunction of equipment important to safety previously
evaluated in the documented safety analysis could be increased;
(ii) The possibility of an accident or malfunction of a different
type than any evaluated previously in the documented safety analysis
could be created; or
(iii) The documented safety analysis may not be bounding or may be
otherwise inadequate.
Unreviewed Safety Question process means the mechanism for keeping
a safety basis current by reviewing potential unreviewed safety
questions, reporting unreviewed safety questions to DOE, and obtaining
approval from DOE prior to taking any action that involves an
unreviewed safety question.
Use and application provisions means the basic instructions for
applying technical safety requirements.
(b) Terms defined in the Act or in 10 CFR part 820 and not defined
in this section of the rule are to be used consistent with the meanings
given in the Act or in 10 CFR part 820.
Sec. 830.4 General requirements.
(a) No person may take or cause to be taken any action inconsistent
with the requirements of this part.
(b) A contractor responsible for a nuclear facility must ensure
implementation of, and compliance with, the requirements of this part.
(c) The requirements of this part must be implemented in a manner
that provides reasonable assurance of adequate protection of workers,
the public, and the environment from adverse consequences, taking into
account the work to be performed and the associated hazards.
(d) If there is no contractor for a DOE nuclear facility, DOE must
ensure implementation of, and compliance with, the requirements of this
part.
Sec. 830.5 Enforcement.
The requirements in this part are DOE Nuclear Safety Requirements
and are subject to enforcement by all appropriate means, including the
imposition of civil and criminal penalties in accordance with the
provisions of 10 CFR part 820.
Sec. 830.6 Recordkeeping.
A contractor must maintain complete and accurate records as
necessary to substantiate compliance with the requirements of this
part.
[[Page 38991]]
Sec. 830.7 Graded approach.
Where appropriate, a contractor must use a graded approach to
implement the requirements of this part, document the basis of the
graded approach used, and submit that documentation to DOE. The graded
approach may not be used in implementing the unreviewed safety question
(USQ) process or in implementing technical safety requirements.
Subpart A--Quality Assurance Requirements
Sec. 830.120 Scope.
This subpart establishes quality assurance requirements for
contractors conducting activities, including providing items or
services that affect, or may affect, nuclear safety of DOE nuclear
facilities.
Sec. 830.121 Quality Assurance Program (QAP).
(a) Contractors conducting activities, including providing items or
services, that affect, or may affect, the nuclear safety of DOE nuclear
facilities must conduct work in accordance with the Quality Assurance
criteria in Sec. 830.122.
(b) The contractor responsible for a DOE nuclear facility must:
(1) Submit a QAP to DOE for approval and regard the QAP as approved
90 days after submittal, unless it is approved or rejected by DOE at an
earlier date.
(2) Modify the QAP as directed by DOE.
(3) Annually submit any changes to the DOE-approved QAP to DOE for
approval. Justify in the submittal why the changes continue to satisfy
the quality assurance requirements.
(4) Conduct work in accordance with the QAP.
(c) The QAP must:
(1) Describe how the quality assurance criteria of Sec. 830.122
are satisfied.
(2) Integrate the quality assurance criteria with the Safety
Management System, or describe how the quality assurance criteria apply
to the Safety Management System.
(3) Use voluntary consensus standards in its development and
implementation, where practicable and consistent with contractual and
regulatory requirements, and identify the standards used.
(4) Describe how the contractor responsible for the nuclear
facility ensures that subcontractors and suppliers satisfy the criteria
of Sec. 830.122.
Sec. 830.122 Quality assurance criteria.
The QAP must address the following management, performance, and
assessment criteria:
(a) Criterion 1--Management/Program. (1) Establish an
organizational structure, functional responsibilities, levels of
authority, and interfaces for those managing, performing, and assessing
the work.
(2) Establish management processes, including planning, scheduling,
and providing resources for the work.
(b) Criterion 2--Management/Personnel Training and Qualification.
(1) Train and qualify personnel to be capable of performing their
assigned work.
(2) Provide continuing training to personnel to maintain their job
proficiency.
(c) Criterion 3--Management/Quality Improvement. (1) Establish and
implement processes to detect and prevent quality problems.
(2) Identify, control, and correct items, services, and processes
that do not meet established requirements.
(3) Identify the causes of problems and work to prevent recurrence
as a part of correcting the problem.
(4) Review item characteristics, process implementation, and other
quality-related information to identify items, services, and processes
needing improvement.
(d) Criterion 4--Management/Documents and Records. (1) Prepare,
review, approve, issue, use, and revise documents to prescribe
processes, specify requirements, or establish design.
(2) Specify, prepare, review, approve, and maintain records.
(e) Criterion 5--Performance/Work Processes. (1) Perform work
consistent with technical standards, administrative controls, and other
hazard controls adopted to meet regulatory or contract requirements,
using approved instructions, procedures, or other appropriate means.
(2) Identify and control items to ensure their proper use.
(3) Maintain items to prevent their damage, loss, or deterioration.
(4) Calibrate and maintain equipment used for process monitoring or
data collection.
(f) Criterion 6--Performance/Design. (1) Design items and processes
using sound engineering/scientific principles and appropriate
standards.
(2) Incorporate applicable requirements and design bases in design
work and design changes.
(3) Identify and control design interfaces.
(4) Verify or validate the adequacy of design products using
individuals or groups other than those who performed the work.
(5) Verify or validate work before approval and implementation of
the design.
(g) Criterion 7--Performance/Procurement. (1) Procure items and
services that meet established requirements and perform as specified.
(2) Evaluate and select prospective suppliers on the basis of
specified criteria.
(3) Establish and implement processes to ensure that approved
suppliers continue to provide acceptable items and services.
(h) Criterion 8--Performance/Inspection and Acceptance Testing. (1)
Inspect and test specified items, services, and processes using
established acceptance and performance criteria.
(2) Calibrate and maintain equipment used for inspections and
tests.
(i) Criterion 9--Assessment/Management Assessment. Ensure managers
assess their management processes and identify and correct problems
that hinder the organization from achieving its objectives.
(j) Criterion 10--Assessment/Independent Assessment. (1) Plan and
conduct independent assessments to measure item and service quality, to
measure the adequacy of work performance, and to promote improvement.
(2) Establish sufficient authority, and freedom from line
management, for the group performing independent assessments.
(3) Ensure persons who perform independent assessments are
technically qualified and knowledgeable in the areas to be assessed.
Subpart B--Safety Basis Requirements
Sec. 830.200 Scope.
This Subpart establishes safety basis requirements for Hazard
Category 1, 2, and 3 DOE nuclear facilities.
Sec. 830.201 Performance of work.
A contractor must perform work in accordance with the DOE-approved
safety basis for a Hazard Category 1, 2, or 3 DOE nuclear facility and,
in particular, with the hazard controls that ensure adequate protection
of workers, the public, and the environment.
Sec. 830.202 Safety basis.
(a) The contractor responsible for a Hazard Category 1, 2, or 3 DOE
nuclear facility must establish and maintain the safety basis for the
facility.
(b) In establishing the safety basis for a Hazard Category 1, 2, or
3 DOE
[[Page 38992]]
nuclear facility, the contractor responsible for the facility must:
(1) Define the scope of the work to be performed;
(2) Identify and analyze the hazards associated with the work;
(3) Categorize the facility consistent with DOE-STD-1027-92
(``Hazard Categorization and Accident Analysis Techniques for
compliance with DOE Order 5480.23, Nuclear Safety Analysis Reports,''
Change Notice 1, September 1997), or successor document;
(4) Prepare a documented safety analysis for the facility; and
(5) Establish the hazard controls upon which the contractor will
rely to ensure adequate protection of workers, the public, and the
environment.
(c) In maintaining the safety basis for a Hazard Category 1, 2, or
3 DOE nuclear facility, the contractor responsible for the facility
must:
(1) Update the safety basis to keep it current and to reflect
changes in the facility, the work and the hazards as they are analyzed
in the documented safety analysis;
(2) Annually provide DOE the current documented safety analysis or
a letter stating that there have been no changes in the documented
safety analysis since the prior submittal; and
(3) Incorporate in the safety basis any changes, conditions, or
hazard controls directed by DOE.
Sec. 830.203 Unreviewed safety question process.
(a) The contractor responsible for a Hazard Category 1, 2, or 3 DOE
nuclear facility must establish, implement, and take actions consistent
with a DOE-approved USQ procedure that meets the requirements of this
section.
(b) The contractor responsible for a new Hazard Category 1, 2, or 3
DOE nuclear facility must submit for DOE approval a procedure for its
USQ process on a schedule that allows DOE approval in a safety
evaluation report issued pursuant to section 207(a) of this Part.
(c) The contractor responsible for a Hazard Category 1, 2, or 3 DOE
nuclear facility must implement the DOE- approved USQ procedure in
situations where there is a:
(1) Temporary or permanent change in the facility as described in
the existing documented safety analysis;
(2) Temporary or permanent change in the procedures as described in
the existing documented safety analysis;
(3) Test or experiment not described in the existing documented
safety analysis; or
(4) Potential inadequacy of the documented safety analysis because
the analysis potentially may not be bounding or may be otherwise
inadequate.
(d) A contractor responsible for a Hazard Category 1, 2, or 3 DOE
nuclear facility must obtain DOE approval prior to taking any action
determined to involve a USQ.
(e) The contractor responsible for a Hazard Category 1, 2, or 3 DOE
nuclear facility must annually provide to DOE a summary of the USQ
determinations performed since the prior submittal.
(f) If a contractor responsible for a Hazard Category 1, 2, or 3
DOE nuclear facility discovers or is made aware of a potential
inadequacy of the documented safety analysis, it must:
(1) Take action, as appropriate, to place or maintain the facility
in a safe condition until an evaluation of the safety of the situation
is completed;
(2) Notify DOE of the situation;
(3) Perform a USQ determination and notify DOE promptly of the
results; and
(4) Submit the evaluation of the safety of the situation to DOE
prior to removing any operational restrictions initiated to meet
paragraph (f)(1) of this section.
Sec. 830.204 Documented safety analysis.
(a) The contractor responsible for a Hazard Category 1, 2, or 3 DOE
nuclear facility must obtain approval from DOE for the methodology used
to prepare the documented safety analysis for the facility unless the
contractor uses a methodology set forth in Table 1 of Appendix A to
this Part.
(b) The documented safety analysis for a Hazard Category 1, 2, or 3
DOE nuclear facility must, as appropriate for the complexities and
hazards associated with the facility:
(1) Describe the facility (including the design of safety
structures, systems and components) and the work to be performed;
(2) Provide a systematic identification of both natural and man-
made hazards associated with the facility;
(3) Evaluate normal, abnormal, and accident conditions, including
consideration of natural and man-made external events, identification
of energy sources or processes that might contribute to the generation
or uncontrolled release of radioactive and other hazardous materials,
and consideration of the need for analysis of accidents which may be
beyond the design basis of the facility;
(4) Derive the hazard controls necessary to ensure adequate
protection of workers, the public, and the environment, demonstrate the
adequacy of these controls to eliminate, limit, or mitigate identified
hazards, and define the process for maintaining the hazard controls
current at all times and controlling their use;
(5) Define the characteristics of the safety management programs
necessary to ensure the safe operation of the facility, including
(where applicable) quality assurance, procedures, maintenance,
personnel training, conduct of operations, emergency preparedness, fire
protection, waste management, and radiation protection; and
(6) With respect to a nonreactor nuclear facility with fissionable
material in a form and amount sufficient to pose a potential for
criticality, define a criticality safety program that:
(i) Ensures that operations with fissionable material remain
subcritical under all normal and credible abnormal conditions;
(ii) Identifies applicable nuclear criticality safety standards;
and
(iii) Describes how the program meets applicable nuclear
criticality safety standards.
Sec. 830.205 Technical safety requirements.
(a) A contractor responsible for a Hazard Category 1, 2, or 3 DOE
nuclear facility must:
(1) Develop technical safety requirements that are derived from the
documented safety analysis;
(2) Prior to use, obtain DOE approval of technical safety
requirements and any change to technical safety requirements; and
(3) Notify DOE of any violation of a technical safety requirement.
(b) A contractor may take emergency actions that depart from an
approved technical safety requirement when no actions consistent with
the technical safety requirement are immediately apparent, and when
these actions are needed to protect workers, the public or the
environment from imminent and significant harm. Such actions must be
approved by a certified operator for a reactor or by a person in
authority as designated in the technical safety requirements for
nonreactor nuclear facilities. The contractor must report the emergency
actions to DOE as soon as practicable.
(c) A contractor for an environmental restoration activity may
follow the provisions of 29 CFR 1910.120 or 1926.65 to develop the
appropriate hazard controls (rather than the provisions for technical
safety requirements in paragraph (a) of this section), provided the
activity involves either:
(1) Work not done within a permanent structure, or
[[Page 38993]]
(2) The decommissioning of a facility with only low-level residual
fixed radioactivity.
Sec. 830.206 Preliminary documented safety analysis.
Prior to construction of a new Hazard Category 1, 2, or 3 DOE
nuclear facility or a major modification to an existing Hazard Category
1, 2, or 3 DOE nuclear facility, the contractor responsible for the
design and construction of the new facility or major modification must:
(a) Prepare a preliminary documented safety analysis for the
facility, and
(b) Obtain DOE approval of:
(1) The nuclear safety design criteria to be used in preparing the
preliminary documented safety analysis unless the contractor uses the
design criteria in DOE Order 420.1, Facility Safety, or successor
document; and
(2) The preliminary documented safety analysis before the
contractor can procure materials or components or begin construction;
provided that DOE may authorize the contractor to perform limited
procurement and construction activities without approval of a
preliminary documented safety analysis if DOE determines that the
activities are not detrimental to public health and safety and are in
the best interests of DOE.
Sec. 830.207 DOE approval of safety basis.
(a) With respect to a new Hazard Category 1, 2, or 3 DOE nuclear
facility or a major modification to an existing Hazard Category 1, 2,
or 3 DOE nuclear facility, a contractor may not begin operation of the
facility or modification prior to the issuance of a safety evaluation
report in which DOE approves the safety basis for the facility or
modification.
(b) Pending issuance of a safety evaluation report in which DOE
approves an updated or amended safety basis for an existing Hazard
Category 1, 2, or 3 DOE nuclear facility, the contractor responsible
for the facility must continue to perform work in accordance with the
DOE-approved safety basis for the facility and maintain the existing
safety basis consistent with the requirements of this Subpart.
Appendix A to Subpart B to Part 830--General Statement of Safety Basis
Policy
A. Introduction
This appendix describes DOE's expectations for the safety basis
requirements of 10 CFR part 830, acceptable methods for implementing
these requirements, and criteria DOE will use to evaluate compliance
with these requirements. This Appendix does not create any new
requirements and should be used consistently with DOE's policy that
work be conducted safely and efficiently and in a manner that
ensures protection of workers, the public, and the environment.
B. Purpose
1. The safety basis requirements of part 830 require the
contractor responsible for a DOE nuclear facility to analyze the
facility, the work to be performed, and the associated hazards and
to identify the conditions, safe boundaries, and hazard controls
necessary to protect workers, the public and the environment from
adverse consequences. These analyses and hazard controls constitute
the safety basis upon which the contractor and DOE rely to conclude
that the facility can be operated safely. Performing work consistent
with the safety basis provides reasonable assurance of adequate
protection of workers, the public, and the environment.
2. The safety basis requirements are intended to further the
objective of making safety an integral part of how work is performed
throughout the DOE complex. Developing a thorough understanding of a
nuclear facility, the work to be performed, the associated hazards
and the needed hazard controls is essential to integrating safety
into management and work at all levels. Performing work in
accordance with the safety basis for a nuclear facility is the
realization of that objective.
C. Scope
1. A contractor must establish and maintain a safety basis for a
Hazard Category 1, 2, or 3 DOE nuclear facility because these
facilities have the potential for significant radiological
consequences. DOE-STD-1027 sets forth the methodology for
categorizing a DOE nuclear facility based on the inventory of
radioactive materials.
2. Unlike the quality assurance requirements of part 830 that
apply to all DOE nuclear facilities the safety basis requirements
only apply to Hazard Category 1, 2, and 3 DOE nuclear facilities and
do not apply to nuclear facilities below Hazard Category 3.
D. Integrated Safety Management
1. The safety basis requirements are consistent with integrated
safety management. DOE expects that, if a contractor complies with
the Department of Energy Acquisition Regulation (DEAR) clause on
integration of environment, safety, and health into work planning
and execution (48 CFR 970.5223-1, Integration of Environment, Safety
and Health into Work Planning and Execution) and the DEAR clause on
laws, regulations, and DOE directives (48 CFR 970.5204-2, Laws,
Regulations and DOE Directives), the contractor will have
established the foundation to meet the safety basis requirements.
2. The processes embedded in a safety management system should
lead to a contractor establishing adequate safety bases and safety
management programs that will meet the safety basis requirements of
this Subpart. Consequently, the DOE expects if a contractor has
adequately implemented integrated safety management, few additional
requirements will stem from this Subpart and, in such cases, the
existing safety basis prepared in accordance with integrated safety
management provisions, including existing DOE safety requirements in
contracts, should meet the requirements of this Subpart.
3. DOE does not expect there to be any conflict between
contractual requirements and regulatory requirements. In fact, DOE
expects that contract provisions will be used to provide more detail
on implementation of safety basis requirements such as preparing a
documented safety analysis, developing technical safety
requirements, and implementing a USQ process.
E. Enforcement of Safety Basis Requirements
1. Enforcement of the safety basis requirements will be
performance oriented. That is, DOE will focus its enforcement
efforts on whether a contractor operates a nuclear facility
consistent with the safety basis for the facility and, in
particular, whether work is performed in accordance with the safety
basis.
2. As part of the approval process, DOE will review the content
and quality of the safety basis documentation. DOE intends to use
the approval process to assess the adequacy of a safety basis
developed by a contractor to ensure that workers, the public, and
the environment are provided reasonable assurance of adequate
protection from identified hazards. Once approved by DOE, the safety
basis documentation will not be subject to regulatory enforcement
actions unless DOE determines that the information which supports
the documentation is not complete and accurate in all material
respects, as required by 10 CFR 820.11. This is consistent with the
DOE enforcement provisions and policy in 10 CFR part 820.
3. DOE does not intend the adoption of the safety basis
requirements to affect the existing quality assurance requirements
or the existing obligation of contractors to comply with the quality
assurance requirements. In particular, in conjunction with the
adoption of the safety basis requirements, DOE revised the language
in 10 CFR 830.122(e)(1) to make clear that hazard controls are part
of the work processes to which a contractor and other persons must
adhere when performing work. This obligation to perform work
consistent with hazard controls adopted to meet regulatory or
contract requirements existed prior to the adoption of the safety
basis requirements and is both consistent with and independent of
the safety basis requirements.
4. A documented safety analysis must address all hazards (that
is, both radiological and nonradiological hazards) and the controls
necessary to provide adequate protection to the public, workers, and
the environment from these hazards. Section 234A of the Atomic
Energy Act only authorizes DOE to issue civil penalties for
violations of requirements related to nuclear safety. Therefore, DOE
will impose civil penalties for violations of the safety basis
requirements (including hazard controls) only if they are related to
nuclear safety.
F. Documented Safety Analysis
1. A documented safety analysis must demonstrate the extent to
which a nuclear facility can be operated safely with respect to
workers, the public, and the environment.
[[Page 38994]]
2. DOE expects a contractor to use a graded approach to develop
a documented safety analysis and describe how the graded approach
was applied. The level of detail, analysis, and documentation will
reflect the complexity and hazards associated with a particular
facility. Thus, the documented safety analysis for a simple, low
hazard facility may be relatively short and qualitative in nature,
while the documented safety analysis for a complex, high hazard
facility may be quite elaborate and more quantitative. DOE will work
with its contractors to ensure a documented safety analysis is
appropriate for the facility for which it is being developed.
3. Because DOE has ultimate responsibility for the safety of its
facilities, DOE will review each documented safety analysis as: (1)
Part of the initial submittal; (2) when revisions are submitted as
part of a positive USQ or major modification; (3) if DOE has reason
to believe a portion of the safety basis to be inadequate, or; (4)
if DOE has reason to believe a portion of the safety basis has
substantially changed. DOE will review the DSA to determine whether
the rigor and detail of the documented safety analysis are
appropriate for the complexity and hazards expected at the nuclear
facility. In particular, DOE will evaluate the documented safety
analysis by considering the extent to which the documented safety
analysis (1) satisfies the provisions of the methodology used to
prepare the documented safety analysis and (2) adequately addresses
the criteria set forth in 10 CFR 830.204(b). DOE will prepare a
Safety Evaluation Report to document the results of its review of
the documented safety analysis. A documented safety analysis must
contain any conditions or changes required by DOE in the Safety
Evaluation Report. Generally, DOE's review of the annual submittal
may be limited to ensuring that the results of USQs have been
adequately incorporated into the DSA. If additional changes are
proposed by the contractor and included in the annual update that
have not been previously approved by DOE or have not been evaluated
as a part of the USQ process, DOE must review and approve these
changes. DOE has the authority to review the safety basis at any
time.
4. In most cases, the contract will provide the framework for
specifying the methodology and schedule for developing a documented
safety analysis. Table 1 sets forth acceptable methodologies for
preparing a documented safety analysis.
Table 1
------------------------------------------------------------------------
The contractor responsible May prepare its document safety analysis
for: by:
------------------------------------------------------------------------
(1) A DOE reactor............ Using the method in U.S. Nuclear
Regulatory Commission Regulatory Guide
1.70, Standard Format and Content of
Safety Analysis Reports for Nuclear
Power Plants, or successor document.
(2) A DOE nonreactor nuclear Using the method in DOE-STD-3009, Change
facility. Notice No. 1, January 2000, Preparation
Guide for U.S. Department of Energy
Nonreactor Nuclear Facility Safety
Analysis Reports, July 1994, or
successor document.
(3) A DOE nuclear facility Using the method in either:
with a limited operational (1) DOE-STD-3009-, Change Notice No. 1,
life. January 2000, or successor document, or
(2) DOE-STD-3011-94, Guidance for
Preparation of DOE 5480.22 (TSR) and DOE
5480.23 (SAR) Implementation Plans,
November 1994, or successor document.
(4) The deactivation or the Using the method in either:
transition surveillance and (1) DOE-STD-3009, Change Notice No. 1,
maintenance of a DOE nuclear January 2000, or successor document, or
facility. (2) DOE-STD-3011-94 or successor
document.
(5) The decommissioning of a (1) Using the method in DOE-STD-1120-98,
DOE nuclear facility. Integration of Environment, Safety, and
Health into Facility Disposition
Activities, May 1998, or successor
document;
(2) Using the provisions in 29 CFR
1910.120 (or 29 CFR 1926.65 for
construction activities) for developing
Safety and Health Programs, Work Plans,
Health and Safety Plans, and Emergency
Response Plans to address public safety,
as well as worker safety; and
(3) Deriving hazard controls based on the
Safety and Health Programs, the Work
Plans, the Health and Safety Plans, and
the Emergency Response Plans.
(6) A DOE environmental (1) Using the method in DOE-STD-1120-98
restoration activity that or successor document, and
involves either work not (2) Using the provisions in 29 CFR
done within a permanent 1910.120 (or 29 CFR 1926.65 for
structure or the construction activities) for developing
decommissioning of a a Safety and Health Program and a site-
facility with only low-level specific Health and Safety Plan
residual fixed radioactivity. (including elements for Emergency
Response Plans, conduct of operations,
training and qualifications, and
maintenance management).
(7) A DOE nuclear explosive Developing its documented safety analysis
facility and the nuclear in two pieces:
explosive operations (1) A Safety Analysis Report for the
conducted therein.. nuclear facility that considers the
generic nuclear explosive operations and
is prepared in accordance with DOE-STD-
3009, Change Notice No. 1, January 2000,
or successor document, and
(2) A Hazard Analysis Report for the
specific nuclear explosive operations
prepared in accordance with DOE-STD-3016-
99, Hazards Analysis Reports for Nuclear
Explosive Operations, February 1999, or
successor document.
(8) A DOE Hazard Category 3 Using the methods in Chapters 2, 3, 4,
nonreactor nuclear facility. and 5 of DOE-STD-3009, Change Notice No.
1, January 2000, or successor document
to ad- dress in a simplified fashion:
(1) The basic description of the facility/
activity and its operations, including
safety structures, systems, and
components;
(2) A qualitative hazards analysis; and
(3) The hazard controls (consisting
primarily of inventory limits and safety
management programs) and their bases.
(9) Transportation activities (1) Preparing a Safety Analysis Report
for Packaging in accordance with DOE-O-
460.1A, Packaging and Transportation
Safety, October 2, 1996, or successor
document and
(2) Preparing a Transportation Safety
Document in accordance with DOE-G-460.1-
1, Implementation Guide for Use with DOE
O 460.1A, Packaging and Transportation
Safety, June 5, 1997, or successor
document.
(10) Transportation and (1) Preparing a Safety Analysis Report
onsite transfer of nuclear for Packaging in accordance with DOE-O-
explosives, nuclear 461.1, Packaging and Transportation of
components, Navel nuclear Materials of National Security Interest,
fuel elements, Category I September 29, 2000, or successor
and Category II special document and
nuclear materials, special (2) Preparing a Transportation Safety
assemblies, and other Document in accordance with DOE-M-461.1-
materials of national 1, Packaging and Transfer of Materials
security. of National Security Interest Manual,
September 29, 2000, or successor
document.
------------------------------------------------------------------------
[[Page 38995]]
5. Table 1 refers to specific types of nuclear facilities. These
references are not intended to constitute an exhaustive list of the
specific types of nuclear facilities. Part 830 defines nuclear
facility broadly to include reactor or a nonreactor nuclear
facilities where an activity is conducted for or on behalf of DOE
and includes any related area, structure, facility, or activity to
the extent necessary to ensure proper implementation of the
requirements established by this Part. The only exceptions are those
facilities specifically excluded such as accelerators. Table 2
defines the terms referenced in Table 1 that are not defined in 10
CFR 830.3.
Table 2
------------------------------------------------------------------------
For purposes of Table 1: Means:
------------------------------------------------------------------------
(1) Deactivation............. The process of placing a facility in a
stable and known condition, including
the removal of hazardous and radioactive
materials.
(2) Decontamination.......... The removal or reduction of residual
radioactive and hazardous materials by
mechanical, chemical, or other
techniques to achieve a stated objective
or end condition.
(3) Decommissioning.......... Those actions taking place after
deactivation of a nuclear facility to
retire it from service and includes
surveillance and maintenance,
decontamination, and/or dismantlement.
(4) Environmental restoration The process by which contaminated sites
activities. and facilities are identified and
characterized and by which existing
contamination is contained, or removed
and disposed.
(5) Generic nuclear explosive A characterization that considers the
operation. collective attributes (such as special
facility system requirements, physical
weapon characteristics, or quantities
and chemical/physical forms of hazardous
materials) for all projected nuclear
explosive operations to be conducted at
a facility.
(6) Nuclear explosive A nuclear facility at which nuclear
facility. operations and activities involving a
nuclear explosive may be conducted.
(7) Nuclear explosive Any activity involving a nuclear
operation. explosive, including activities in which
main-charge, high-explosive parts and
pits are collocated.
(8) Nuclear facility with a A nuclear facility for which there is a
limited operational life. short remaining operational period
before ending the facility's mission and
initiating deactivation and
decommissioning and for which there are
no intended additional missions other
than cleanup.
(9) Specific nuclear A specific nuclear explosive subjected to
explosive operation. the stipulated steps of an individual
operation, such as assembly or
disassembly.
(10) Transition surveillance Activities conducted when a facility is
and maintenance activities. not operating or during deactivation,
decontamination, and decommissioning
operations when surveillance and
maintenance are the predominant
activities being conducted at the
facility. These activities are necessary
for satisfactory containment of
hazardous materials and protection of
workers, the public, and the
environment. These activities include
providing periodic inspections,
maintenance of structures, systems, and
components, and actions to prevent the
alteration of hazardous materials to an
unsafe state.
------------------------------------------------------------------------
6. The contractor responsible for the design and construction of
a new Hazard Category 1, 2, or 3 DOE nuclear facility or a major
modification to an existing Hazard Category 1, 2, or 3 DOE nuclear
facility must prepare a preliminary documented safety analysis. A
preliminary documented safety analysis can ensure that substantial
costs and time are not wasted in constructing a nuclear facility
that will not be acceptable to DOE. If a contractor is required to
prepare a preliminary documented safety analysis, the contractor
must obtain DOE approval of the preliminary documented safety
analysis prior to procuring materials or components or beginning
construction. DOE, however, may authorize the contractor to perform
limited procurement and construction activities without approval of
a preliminary documented safety analysis if DOE determines that the
activities are not detrimental to public health and safety and are
in the best interests of DOE. DOE Order 420.1, or successor
document, sets forth acceptable nuclear safety design criteria for
use in preparing a preliminary documented safety analysis. As a
general matter, DOE does not expect preliminary documented safety
analyses to be needed for activities that do not involve significant
construction such as environmental restoration activities,
decontamination and decommissioning activities, specific nuclear
explosive operations, or transition surveillance and maintenance
activities.
G. Hazard Controls
1. Hazard controls are measures to eliminate, limit, or mitigate
hazards to workers, the public, or the environment. They include:
(1) Physical, design, structural, and engineering features; (2)
safety structures, systems, and components; (3) safety management
programs; (4) technical safety requirements; and (5) other controls
necessary to provide adequate protection from hazards.
2. The types and specific characteristics of the safety
management programs necessary for a DOE nuclear facility will be
dependent on the complexity and hazards associated with the nuclear
facility and the work being performed. In most cases, however, a
contractor should consider safety management programs covering
topics such as quality assurance, procedures, maintenance, personnel
training, conduct of operations, criticality safety, emergency
preparedness, fire protection, waste management, and radiation
protection. In general, DOE Orders set forth DOE's expectations
concerning specific topics. For example, DOE Order 420.1, or
successor document provides DOE's expectations with respect to fire
protection and criticality safety.
3. Safety structures, systems, and components require formal
definition of minimum acceptable performance in the documented
safety analysis. This is accomplished by first defining a safety
function, then describing the structure, systems, and components,
placing functional requirements on those portions of the structures,
systems, and components required for the safety function, and
identifying performance criteria that will ensure functional
requirements are met. Technical safety requirements are developed to
ensure the operability of the safety structures, systems, and
components and define actions to be taken if a safety structure,
system, or component is not operable.
4. Technical safety requirements establish limits, controls, and
related actions necessary for the safe operation of a nuclear
facility. The exact form and contents of technical safety
requirements will depend on the circumstances of a particular
nuclear facility as defined in the documented safety analysis for
the nuclear facility. As appropriate, technical safety requirements
may have sections on: (1) Safety limits; (2) operating limits; (3)
surveillance requirements; (4) administrative controls; (5) use and
application; and (6) design features. It may also have an appendix
on the bases for the limits and requirements. DOE Guide 423.1-1B,
Implementation Guide for Use in Developing Technical Safety
Requirements, or successor document, provides a complete description
of what technical safety requirements should contain and how they
should be developed and maintained.
[[Page 38996]]
5. DOE will examine and approve the technical safety
requirements as part of preparing the safety evaluation report and
reviewing updates to the safety basis. As with all hazard controls,
technical safety requirements must be kept current and reflect
changes in the facility, the work and the hazards as they are
analyzed in the documented safety analysis. In addition, DOE expects
a contractor to maintain technical safety requirements, and other
hazard controls as appropriate, as controlled documents with an
authorized users list.
6. Table 3 sets forth DOE's expectations concerning acceptable
technical safety requirements.
Table 3
------------------------------------------------------------------------
As appropriate for a
particular DOE nuclear
facility, the section of the Will provide information on:
technical safety requirements
on:
------------------------------------------------------------------------
(1) Safety limits............ The limits on process variables
associated with those safety class
physical barriers, generally passive,
that are necessary for the intended
facility function and that are required
to guard against the uncontrolled
release of radioactive materials. The
safety limit section describes, as
precisely as possible, the parameters
being limited, states the limit in
measurable units (pressure, temperature,
flow, etc.), and indicates the
applicability of the limit. The safety
limit section also describes the actions
to be taken in the event that the safety
limit is exceeded. These actions should
first place the facility in the safe,
stable condition attainable, including
total shutdown (except where such action
might reduce the margin of safety) or
should verify that the facility already
is safe and stable and will remain so.
The technical safety requirement should
state that the contractor must obtain
DOE authorization to restart the nuclear
facility following a violation of a
safety limit. The safety limit section
also establishes the steps and time
limits to correct the out-of-
specification condition.
(2) Operating limits......... Those limits which are required to ensure
the safe operation of a nuclear
facility. The operating limits section
may include subsections on limiting
control settings and limiting conditions
for operation.
(3) Limiting control settings The settings on safety systems that
control process variables to prevent
exceeding a safety limit. The limited
control settings section normally
contains the settings for automatic
alarms and for the automatic or non-
automatic initiation of protective
actions related to those variables
associated with the function of safety
class structures, systems, or components
if the safety analysis shows that they
are relied upon to mitigate or prevent
an accident. The limited control
settings section also identifies the
protective actions to be taken at the
specific settings chosen in order to
correct a situation automatically or
manually such that the related safety
limit is not exceeded. Protective
actions may include maintaining the
variables within the requirements and
repairing the automatic device promptly
or shutting down the affected part of
the process and, if required, the entire
facility.
(4) Limiting conditions for The limits that represent the lowest
operations. functional capability or performance
level of safety structures, systems, and
components required to perform an
activity safely. The limiting conditions
for operation section describes, as
precisely as possible, the lowest
functional capability or performance
level of equipment required for
continued safe operation of the
facility. The limiting conditions for
operation section also states the action
to be taken to address a condition not
meeting the limiting conditions for
operation section. Normally this simply
provides for the adverse condition being
corrected in a certain time frame and
for further action if this is
impossible.
(5) Surveillance requirements Requirements relating to test,
calibration, or inspection to assure
that the necessary operability and
quality of safety structures, systems,
and components is maintained; that
facility operation is within safety
limits; and that limiting control
settings and limiting conditions for
operation are met. If a required
surveillance is not successfully
completed, the contractor is expected to
assume the systems or components
involved are inoperable and take the
actions defined by the technical safety
requirement until the systems or
components can be shown to be operable.
If, however, a required surveillance is
not performed within its required
frequency, the contractor is allowed to
perform the surveillance within 24 hours
or the original frequency, whichever is
smaller, and confirm operability.
(6) Administrative controls.. Organization and management, procedures,
recordkeeping, assessment, and reporting
necessary to ensure safe operation of a
facility consistent with the technical
safety requirement. In general, the
administrative controls section
addresses (1) the requirements
associated with administrative controls,
(including those for reporting
violations of the technical safety
requirement); (2) the staffing
requirements for facility positions
important to safe conduct of the
facility; and (3) the commitments to the
safety management programs identified in
the documented safety analysis as
necessary components of the safety basis
for the facility.
(7) Use and application The basic instructions for applying the
provisions. safety restrictions contained in a
technical safety requirement. The use
and application section includes
definitions of terms, operating modes,
logical connectors, completion times,
and frequency notations.
(8) Design features.......... Design features of the facility that, if
altered or modified, would have a
significant effect on safe operation.
(9) Bases appendix........... The reasons for the safety limits,
operating limits, and associated
surveillance requirements in the
technical safety requirements. The
statements for each limit or requirement
shows how the numeric value, the
condition, or the surveillance fulfills
the purpose derived from the safety
documentation. The primary purpose for
describing the basis of each limit or
requirement is to ensure that any future
changes to the limit or requirement is
done with full knowledge of the original
intent or purpose of the limit or
requirement.
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[[Page 38997]]
H. Unreviewed Safety Questions
1. The USQ process is an important tool to evaluate whether
changes affect the safety basis. A contractor must use the USQ
process to ensure that the safety basis for a DOE nuclear facility
is not undermined by changes in the facility, the work performed,
the associated hazards, or other factors that support the adequacy
of the safety basis.
2. The USQ process permits a contractor to make physical and
procedural changes to a nuclear facility and to conduct tests and
experiments without prior approval, provided these changes do not
cause a USQ. The USQ process provides a contractor with the
flexibility needed to conduct day-to-day operations by requiring
only those changes and tests with a potential to impact the safety
basis (and therefore the safety of the nuclear facility) be approved
by DOE. This allows DOE to focus its review on those changes
significant to safety. The USQ process helps keep the safety basis
current by ensuring appropriate review of and response to situations
that might adversely affect the safety basis.
3. DOE Guide 424.1-1B Chg 2, Implementation Guide for Use in
Addressing Unreviewed Safety Question Requirements, or successor
document provides DOE's expectations for a USQ process. The
contractor must obtain DOE approval of its procedure used to
implement the USQ process. The contractor is allowed to make
editorial and format changes to its USQ procedure while maintaining
DOE approval.
I. Functions and Responsibilities
1. The DOE Management Official for a DOE nuclear facility (that
is, the Assistant Secretary, the Assistant Administrator, or the
Office Director who is primarily responsible for the management of
the facility) has primary responsibility within DOE for ensuring
that the safety basis for the facility is adequate and complies with
the safety basis requirements of Part 830. The DOE Management
Official is responsible for ensuring the timely and proper (1)
review of all safety basis documents submitted to DOE and (2)
preparation of a safety evaluation report concerning the safety
basis for a facility.
2. DOE will maintain a public list on the internet that provides
the status of the safety basis for each Hazard Category 1, 2, or 3
DOE nuclear facility and, to the extent practicable, provides
information on how to obtain a copy of the safety basis and related
documents for a facility.
[FR Doc. 2018-16863 Filed 8-7-18; 8:45 am]
BILLING CODE 6450-01-P