83_FR_39135 83 FR 38982 - Nuclear Safety Management

83 FR 38982 - Nuclear Safety Management

DEPARTMENT OF ENERGY

Federal Register Volume 83, Issue 153 (August 8, 2018)

Page Range38982-38997
FR Document2018-16863

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.

Federal Register, Volume 83 Issue 153 (Wednesday, August 8, 2018)
[Federal Register Volume 83, Number 153 (Wednesday, August 8, 2018)]
[Proposed Rules]
[Pages 38982-38997]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-16863]


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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.

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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.

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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: http://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 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
    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 (http://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 http://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.
------------------------------------------------------------------------


[[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



                                               38982

                                               Proposed Rules                                                                                                Federal Register
                                                                                                                                                             Vol. 83, No. 153

                                                                                                                                                             Wednesday, August 8, 2018



                                               This section of the FEDERAL REGISTER                    Independence Avenue SW, Washington,                     D. Paperwork Reduction Act
                                               contains notices to the public of the proposed          DC 20585.                                               E. National Environmental Policy Act
                                               issuance of rules and regulations. The                    Due to potential delays in DOE’s                      F. Unfunded Mandates Reform Act of 1995
                                               purpose of these notices is to give interested                                                                  G. Treasury and General Government
                                                                                                       receipt and processing of mail sent
                                               persons an opportunity to participate in the                                                                       Appropriations Act, 1999
                                                                                                       through the U.S. Postal Service, we                     H. Executive Order 13132
                                               rule making prior to the adoption of the final
                                               rules.
                                                                                                       encourage respondents to submit                         I. Executive Order 12988
                                                                                                       comments electronically to ensure                       J. Treasury and General Government
                                                                                                       timely receipt.                                            Appropriations Act, 2001
                                               DEPARTMENT OF ENERGY                                    FOR FURTHER INFORMATION CONTACT: Mr.                    K. Executive Order 13211
                                                                                                                                                             V. Approval of the Office of the Secretary
                                                                                                       Garrett Smith, U.S. Department of
                                               10 CFR Part 830                                         Energy, Office of Nuclear Safety, AU–                 I. Introduction and Background
                                               RIN 1992–AA57                                           30, 1000 Independence Avenue SW,
                                                                                                                                                             A. Introduction
                                                                                                       Washington, DC 20585; (301) 903–2996
                                               Nuclear Safety Management                               or nuclearsafety@hq.doe.gov.                             Pursuant to the Atomic Energy Act of
                                                                                                       SUPPLEMENTARY INFORMATION: Public                     1954, as amended (the AEA), the
                                               AGENCY:  Office of Environment, Health,                                                                       Department of Energy (DOE or the
                                                                                                       meetings for this proposed rulemaking
                                               Safety and Security, U.S. Department of                                                                       Department) owns and leases nuclear
                                                                                                       will be held in:
                                               Energy.                                                   1. Richland, WA at the HAMMER                       and non-nuclear facilities at various
                                               ACTION: Notice of proposed rulemaking                   Federal Training Facility, Building                   locations in the United States. These
                                               and notice of public meetings.                          6091, Room 10, 2890 Horn Rapids Road,                 facilities are operated either by DOE or
                                                                                                       Richland, WA, on August 16th, 2018.                   by contractors with DOE oversight.
                                               SUMMARY:    The Department of Energy                                                                          Activities at these facilities include, but
                                                                                                         2. Albuquerque, NM at the
                                               (DOE or the Department) publishes a                                                                           are not limited to: Research, testing,
                                                                                                       Albuquerque Marriott, Sandia Room,
                                               proposed rule to amend regulations                                                                            production, disassembly, or transporting
                                                                                                       2101 Louisiana Blvd. NE, Albuquerque,
                                               concerning nuclear safety management.                                                                         nuclear materials. DOE regulations
                                                                                                       NM, on September 6th, 2018.
                                               These regulations govern the conduct of                                                                       governing nuclear safety at these
                                                                                                         3. Oak Ridge, TN at the Oak Ridge
                                               DOE contractors, DOE personnel, and                                                                           facilities are set forth in the Nuclear
                                                                                                       Associated Universities, Pollard
                                               other persons conducting activities                                                                           Safety Management rule (10 CFR part
                                                                                                       Technology Conference Center
                                               (including providing items and services)                                                                      830). The regulations were issued in
                                                                                                       Auditorium, 210 Badger Avenue, Oak
                                               that affect, or may affect, the safety of                                                                     response to external assessments from
                                                                                                       Ridge, TN, on September 25th, 2018.
                                               DOE nuclear facilities. The proposed                      4. Aiken, SC at the University of                   the National Academy of Sciences
                                               revisions reflect the experience gained                 South Carolina—Aiken, Business and                    (NAS), the enactment of the Price-
                                               in the implementation of the regulations                Education Building, Room 124, 471                     Anderson Amendments Act of 1988
                                               over the past seventeen years, with                     University Parkway, Aiken, SC, on                     (PAAA), and DOE efforts to improve
                                               specific improvements to the process for                September 27th, 2018.                                 safety at DOE nuclear facilities. Aspects
                                               facility hazard categorization, the                       All public meetings will be held from               of 10 CFR part 830 were finalized and
                                               unreviewed safety question process, and                 1 p.m. to 4:30 p.m. and from 6 p.m. to                issued from 1994 to 2001, covering core
                                               the review and approval of safety                       8:30 p.m. local time. Interested persons              safety requirements for quality
                                               documentation. The proposed revisions                   who wish to speak at the public meeting               assurance and facility safety basis. Over
                                               are intended to enhance operational                     should telephone the Office of Nuclear                the past 17 years, DOE has gained
                                               efficiency while maintaining robust                     Safety, (301) 903–2996, by 4:30 p.m.                  considerable experience in the
                                               safety performance.                                     Eastern Time on August 13th, 2018 for                 implementation of 10 CFR part 830, and
                                               DATES: Public comment on this                           Richland, WA, on August 31st, 2018 for                is proposing to modify the requirements
                                               proposed rule will be accepted until                    Albuquerque, NM, on September 18th,                   to incorporate that experience and help
                                               October 9, 2018. For dates and more                     2018 for Oak Ridge, TN, and on                        ensure more effective safety
                                               information on the public meetings for                  September 20th, 2018 for Aiken, SC.                   performance.
                                               this proposed rulemaking, see                           Each presentation is limited to 20                    B. Procedural History of the Rule
                                               SUPPLEMENTARY INFORMATION.                              minutes.                                                On December 9, 1991, DOE published
                                               ADDRESSES: You may submit comments,                     I. Introduction and Background                        Procedural Rules for DOE Nuclear
                                               identified by RIN 1992–AA57, by any of                     A. Introduction                                    Activities (56 FR 64290) and a Notice of
                                               the following methods:                                     B. Procedural History of the Rule                  Proposed Rulemaking and Public
                                                  1. Federal eRulemaking Portal: http://               II. Discussion of Proposed Rule                       Hearing (1991 Notice, 56 FR 64316) to
                                               www.regulations.gov. Follow the                            A. Discussion of Key Proposed Changes
                                                                                                          B. Proposed Changes in Order of
                                                                                                                                                             add Parts 820 and 830 to Title 10 of the
                                               instructions for submitting comments.
                                                                                                                                                             Code of Federal Regulation (CFR).1 Title
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                                                  2. Email: Rulemaking.830@                                  Appearance
                                               hq.doe.gov. Include RIN 1992–AA57 in                    III. Public Comment Procedures
                                                                                                                                                               1 The Department proposed 10 CFR part 820 (Part
                                                                                                          A. Written Comments
                                               the subject line of the email. Please                                                                         820), Procedural Rules for DOE Nuclear Activities,
                                                                                                          B. Public Meetings
                                               include the full body of your comments                  IV. Regulatory Review
                                                                                                                                                             to establish the procedural requirements for
                                               in the text of the message or as an                                                                           enforcement activities in accordance with PAAA.
                                                                                                          A. Review Under Executive Order 12866              On August 17, 1993, the Department issued the
                                               attachment.                                                B. Review Under Executive Orders 13771             Procedural Regulations for DOE Nuclear Activities
                                                  3. Mail: U.S. Department of Energy,                        and 13777                                       in final form as 10 CFR part 820 (58 FR 43680). Part
                                               Office of Nuclear Safety, AU–30, 1000                      C. Regulatory Flexibility Act                      820 establishes the procedures for DOE enforcement



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                                                                     Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Proposed Rules                                          38983

                                               10 CFR part 830 was proposed to                         research, data, and DOE experience with               probability of the occurrence or the
                                               establish safety management                             implementation. This would be                         consequences of an accident or the
                                               requirements for DOE nuclear facilities.                consistent with DOE’s practice to                     malfunction of equipment important to
                                               DOE issued, as final, the sections of 10                periodically evaluate and revise DOE                  safety previously evaluated in the
                                               CFR part 830 related to the initial                     Technical Standards and would follow                  documented safety analysis (DSA) could
                                               provisions (§§ 830.1–830.7) and Subpart                 the development, review, and approval                 be increased; (2) The possibility of an
                                               A—General Provisions, (§§ 830.100–                      process described in DOE Order 252.1A,                accident or malfunction of a different
                                               830.120) on April 5, 1994 (1994 Notice,                 Technical Standards Program. The                      type than any evaluated previously in
                                               59 FR 15843).                                           Technical Standards Program process                   the documented safety analysis could be
                                                 The Department issued a Notice of                     requires concurrence from all affected                created; or (3) A margin of safety could
                                               Limited Reopening of the Comment                        Departmental elements prior to issuance               be reduced; or (4) The documented
                                               Periods for the remaining topics to be                  of any standard.                                      safety analysis may not be bounding or
                                               addressed in 10 CFR part 830 on August                     DOE also proposes to amend Section                 may be otherwise inadequate. As
                                               31, 1995, and for a second, unrelated,                  C, Scope, of Appendix A to remove the                 explained in the following paragraphs,
                                               rule (Reopening Notice, 60 FR 45381).                   reference to the specific version of                  the proposed definition would remove
                                                 On October 10, 2000, the Department                   DOE–STD–1027, for consistency with                    the third situation: ‘‘A margin of safety
                                               published an Interim Final Rule and                     the revision in § 830.202. DOE would                  could be reduced’’.
                                               Opportunity for Public Comment (65 FR                   also remove Table 1 of Appendix A and                    The current set of four situations that
                                               60291) which amended the nuclear                        replace that table with a definition for              define an USQ in 10 CFR 830.3 reflected
                                               safety regulations to (1) establish and                 Hazard Category 1, 2, and 3 DOE                       standard nuclear industry practice and
                                               maintain safety bases for Hazard                        nuclear facilities in § 830.3 that                    was an adaptation of 10 CFR 50.59,
                                               Category 1, 2, and 3 DOE nuclear                        references DOE–STD–1027–92 or                         changes, tests and experiments, used by
                                               facilities and perform work in                          successor document. The removal of                    the United States Nuclear Regulatory
                                               accordance with safety bases, and (2)                   Table 1 would allow successor revisions               Commission (NRC). The NRC, in 1968,
                                               clarify that the quality assurance work                 to more clearly link the determination of             added to § 50.59 the concept of ‘‘margin
                                               process requirements apply to standards                 Hazard Category 1, 2, 3, and below                    of safety as defined in the basis for any
                                               and controls adopted to meet regulatory                 hazard category 3 to the methodology in               technical specification is reduced.’’ In
                                               or contract requirements that may affect                the Standard. The concept that Hazard                 issuing 10 CFR part 830, DOE modified
                                               nuclear safety (Interim Final Rule). The                Category 1 will have higher potential                 this question to simply read ‘‘A margin
                                               Interim Final Rule was also issued to                   consequences and Hazard Category 3                    of safety could be reduced’’. In addition
                                               provide further opportunity for public                  will have lower potential consequences                to adapting the NRC process, DOE
                                               comment on the rule.                                    will be maintained throughout all                     included the situation of ‘‘(4) The
                                                 Following the public comment                          successor documents of DOE–STD–                       documented safety analysis may not be
                                               period, the Department issued a Final                   1027.                                                 bounding or may otherwise be
                                               Rule on January 10, 2001 (66 FR 1810).                     2. Unreviewed Safety Question (USQ)                inadequate.’’
                                               II. Discussion of Proposed Rule                         Process—A situation or potential                         The NRC, after 30 years of experience
                                                                                                       situation outside the bounds of the                   implementing § 50.59, issued an
                                               A. Discussion of Key Proposed Changes                   current safety analysis for a Hazard                  October 21, 1998, Notice of Proposed
                                                  1. DOE Standard 1027—Section                         Category 1, 2, or 3 nuclear facility (as              Rulemaking to change the criteria
                                               830.202 of the regulations requires that                documented in its approved safety                     associated with margin of safety,
                                               DOE nuclear facilities be categorized                   analysis) constitutes an Unreviewed                   explaining that ‘‘the phrases ‘margin of
                                               consistent with DOE–STD–1027–92                         Safety Question under the current                     safety’ and ‘as defined in the basis for
                                               (‘‘Hazard Categorization and Accident                   regulations. Section 830.203 allows                   any technical specification’ in the third
                                               Analysis Techniques for compliance                      contractors to make changes to the                    criterion have been the subject of
                                               with DOE Order 5480.23, Nuclear Safety                  facility, to change site or facility                  differing interpretations because the
                                               Analysis Reports,’’ Change Notice 1,                    procedures, and to conduct tests and/or               rule does not define what constitutes a
                                               September 1997). The Department                         experiments without prior DOE                         margin of safety or a basis for any
                                               continues to believe that the                           approval when these activities do not                 technical specification in the context of
                                               methodology in DOE–STD–1027–92 Ch                       involve an Unreviewed Safety Question                 §§ 50.59 and 72.48. In addition, some
                                               1 is sufficient and supports the                        and do not require any change to                      have questioned the need for the third
                                               categorization of DOE nuclear facilities.               Technical Safety Requirements.                        criterion on ‘margin of safety.’ ’’ The
                                                                                                          The proposed change to Appendix A                  third criterion refers to the existence of
                                               In 2001, when Subpart B of 10 CFR part
                                                                                                       to Subpart B of 10 CFR part 830—                      two prior questions associated with
                                               830 was issued, not every Hazard
                                                                                                       General Statement of Safety Basis                     creation, consequences, and likelihood
                                               Category 1, 2, and 3 DOE nuclear facility
                                                                                                       Policy, H, Unreviewed Safety Questions,               of accidents and equipment
                                               was categorized using a standardized
                                                                                                       would add the sentence, ‘‘The                         malfunction. The revision to 10 CFR
                                               methodology, and therefore consistent
                                                                                                       contractor is allowed to make editorial               part 50 removing the term ‘‘margin of
                                               application of the cited reference,
                                                                                                       and format changes to its USQ                         safety’’ from 10 CFR 50.59 was issued as
                                               without change, was appropriate.
                                                  DOE now proposes, after two decades                  procedure while maintaining DOE                       a final rule on October 4, 1999.
                                                                                                       approval.’’ This proposal would focus                    DOE’s experience with the margin of
                                               of experience in facility categorization
                                                                                                       the requirement to obtain DOE’s                       safety criteria is similar to that
                                               using DOE–STD–1027–92, Ch 1, to
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                                                                                                       approval on changes with the potential                expressed by the NRC in its rulemaking,
                                               amend § 830.202(b)(3) by adding ‘‘or
                                                                                                       to impact on the safety basis of the                  specifically, that the other existing
                                               successor document’’. This change
                                                                                                       facility.                                             criteria provide sufficient guidance to
                                               would allow the Department to revise
                                                                                                          DOE also proposes to modify § 830.3,               identify facility and safety basis changes
                                               the standard to include up-to-date
                                                                                                       Definitions, by changing the definition               that warrant DOE approval. Feedback
                                               actions and for issuing civil and criminal penalties
                                                                                                       for Unreviewed Safety Question (USQ).                 from periodic surveys considering a
                                               for contractor, subcontractor, and supplier             The current definition includes four                  broad-range of USQ determinations
                                               violations of DOE nuclear safety requirements.          situations that define a USQ: (1) The                 indicated that the ‘‘margin of safety’’


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                                               38984                Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Proposed Rules

                                               criterion has not provided benefit                         Therefore, DOE is proposing to                     nuclear facilities (i.e., nuclear facilities
                                               independent of the criteria DOE is                      change the requirement in § 830.202,                  with an approved safety basis).
                                               retaining in the definition of the USQ                  Safety basis, to require the current DSA                DOE proposes to change the
                                               process. In addition, stakeholder                       be provided to DOE annually, but not to               definition of Preliminary documented
                                               feedback noted that the ‘‘margin of                     require DOE approval at that time.                    safety analysis to maintain consistency
                                               safety’’ criterion was subjectively                     Additional guidance would also be                     with other proposed changes to the
                                               interpreted and often diverted safety                   included in Appendix A to Subpart B of                definitions related to nuclear facilities.
                                               resources without a corresponding                       10 CFR part 830—General Statement of                  B. Proposed Changes in Order of
                                               safety benefit. Therefore, the proposed                 Safety Basis Policy, F, Documented                    Appearance
                                               removal of the criterion related to                     Safety Analysis, to make clear that
                                               ‘‘margin of safety’’ would enhance DOE                  DOE’s review and approval of the safety                  The specific proposed changes to 10
                                               and contractor operational effectiveness,               analysis is intended to be focused on                 CFR part 830 are summarized below in
                                               without reducing the level of safety                    changes submitted through the USQ                     the order in which they appear:
                                               provided by the current practice. The                   process, but may require DOE approval                    1. In proposed § 830.3 ‘‘Definitions,’’
                                                                                                                                                             the current definition for Existing DOE
                                               current practice allows contractors to                  if DOE has reason to believe a portion
                                                                                                                                                             nuclear facility would be deleted, a
                                               conduct certain specified activities                    of the safety basis has substantially
                                                                                                                                                             definition for Hazard Category 1, 2, and
                                               without prior DOE approval, when these                  changed. DOE would continue to have
                                                                                                                                                             3 DOE nuclear facilities has been
                                               activities do not cause an Unreviewed                   the authority to review the safety basis
                                                                                                                                                             proposed, and there would be a
                                               Safety Question (and when they do not                   at any time. DOE would maintain the
                                                                                                                                                             modification of the current definition of
                                               require Technical Safety Requirements                   ability to direct the contractor to
                                                                                                                                                             New Hazard Category 1, 2, and 3 DOE
                                               changes).2                                              incorporate in the safety basis any
                                                                                                                                                             nuclear facility. These changes are
                                                 3. DOE Approval of Annual DSA                         changes, conditions, or hazard controls.
                                                                                                                                                             designed to improve the delineation
                                               Updates—As stated above, DOE                               4. Definition and Application of New               between new and existing facilities. The
                                               currently requires the contractor, in                   Facilities, Major Modification,                       definition for Major modification would
                                               § 830.203, Unreviewed Safety Question                   Preliminary Documented Safety                         be changed to remove the effective date
                                               process, to obtain DOE approval prior to                Analysis, and Existing Facilities—The                 associated with the original issuance of
                                               taking any action determined to involve                 current definitions of a New DOE                      the rule. The definition for Preliminary
                                               a USQ. Additionally, in § 830.202 Safety                nuclear facility, Major Modification,                 documented safety analysis would be
                                               basis, DOE requires the contractor to                   Preliminary documented safety                         changed to better reflect the intent of
                                               annually submit to DOE either the                       analysis, and Existing DOE nuclear                    preliminary documented safety analysis
                                               updated DSA for approval or a letter                    facility (and applications of those                   being associated with Hazard Category
                                               stating that there have been no changes                 definitions within the rule) reference                1, 2, or 3 DOE nuclear facilities rather
                                               in the DSA since the prior submission.                  specific dates related to the issuance of             than all DOE nuclear facilities. The
                                               This effectively requires the contractor                the rule and the need to bring DOE                    definition for Safety management
                                               to submit changes to the DSA for DOE                    nuclear facilities into the regulatory                system would be changed to include the
                                               approval twice. Currently, DOE                          framework. DOE is proposing to change                 specific title of 48 CFR 970.5223–1,
                                               provides implementation guidance for                    the definitions to clearly recognize that             Integration of environment, safety, and
                                               this approval process in DOE–STD–                       all current DOE nuclear facilities are                health into work planning and
                                               1104–2016, Review and Approval of                       already within this regulatory                        execution. The definition for
                                               Nuclear Facility Safety Basis and Safety                framework and that new DOE nuclear                    Unreviewed Safety Question (USQ)
                                               Design Basis Documents, Section 7.1.2,                  facilities would be those that are in                 would be changed by adding ‘‘or’’ to the
                                               Review of Safety Basis Changes and                      design or under construction that do not              end of (2), deleting ‘‘(3) A margin of
                                               DSA Annual Updates. The guidance                        yet have a DOE approved safety basis.                 safety could be reduced; or’’, and
                                               states that ‘‘Review and approval of                    Additionally, the specific definition of              renumbering (4) as (3).
                                               revisions and annual updates are a                      an existing DOE nuclear facility is being                2. In proposed § 830.201
                                               matter of endorsing the incorporation of                proposed to be deleted. DOE proposes                  ‘‘Performance of Work,’’ current
                                               changes in the safety basis since the last              instead to rely upon a new definition of              § 830.201 would be changed by adding
                                               approval rather than performing a new                   Hazard Category 1, 2, and 3 DOE                       ‘‘DOE-approved’’ to modify safety basis
                                               assessment of the previously approved                   nuclear facilities and the specific                   to maintain consistency with § 830.207,
                                               safety basis documents.’’ While the                     endpoint of a DOE approved safety basis               DOE approval of safety basis.
                                               guidance is clear in the intent to drive                to delineate between a new facility and                  3. Proposed § 830.202(b)(3) would be
                                               focus of DOE’s approval to the change                   an existing facility.                                 changed to add ‘‘or successor
                                               identified in the USQ process, the                         DOE also proposes to change the                    document’’ to modify DOE–STD–1027–
                                               regulations’ additional requirement for a               definition of a Major modification to                 92 (‘‘Hazard Categorization and
                                               second approval has led to considerable                 remove the completion date of the                     Accident Analysis Techniques for
                                               implementation challenges, and                          facility. The definition would rely upon              compliance with DOE Order 5480.23,
                                               unnecessary review iterations without                   a criteria of a substantial change to the             Nuclear Safety Analysis Reports,’’
                                               providing additional safety benefit.                    existing safety basis for the facility. This          Change Notice 1, September 1997). This
                                                                                                       would link the meaning of ‘‘Major                     proposed change would allow DOE to
                                                 2 DOE’s implementation guidance associated with       modification’’ to changes to existing                 modify the methodology used to
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                                               these criteria is DOE G 424.1–1B Chg 2,                 Hazard Category 1, 2, or 3 nuclear                    perform hazard categorization
                                               Implementation Guide for Use in Addressing
                                               Unreviewed Safety Question Requirements. Based
                                                                                                       facilities via the existence of a safety              consistent with DOE’s policy of
                                               on the four criteria defining a situation involving     basis for the facility. Furthermore,                  maintaining technical standards to
                                               a USQ in 10 CFR part 830, DOE G 424.1–1B Chg            additional clarity is proposed within 10              reflect updated knowledge and
                                               2 contains seven questions. The last question           CFR part 830, subpart B, to highlight                 methods. Current § 830.202(c)(2) would
                                               related to the concept of the margin of safety. If
                                               DOE adopts this proposal in a final rule, DOE
                                                                                                       that the concept of ‘‘Major                           be changed to read, ‘‘(2) Annually
                                               would also conduct a process to consider removal        modification’’ would only apply to                    provide DOE the current documented
                                               of the question from the DOE Guide.                     existing Hazard Category 1, 2, or 3 DOE               safety analysis or a letter stating that


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                                                                    Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Proposed Rules                                           38985

                                               there have been no changes in the                       ongoing updates to the current version                potential for significant radiological
                                               documented safety analysis since the                    of the DOE order.                                     consequences. DOE–STD–1027 sets
                                               prior submittal; and’’. These proposed                     7. In proposed § 830.207 ‘‘DOE                     forth the methodology for categorizing a
                                               changes reflect the removal of the                      approval of safety basis,’’ current                   DOE nuclear facility based on the
                                               requirement for DOE to annually                         § 830.207(a) would be deleted, as DOE                 inventory of radioactive materials.’’
                                               approve the documented safety analysis,                 no longer has existing Hazard Category                Current ‘‘C. Scope, 2.’’ Would be
                                               and are intended to focus DOE’s                         1, 2, or 3 facilities operated outside of             changed to delete the parenthetical
                                               approval on the existing requirement to                 10 CFR part 830. Current § 830.207(b)                 reference to ‘‘including radiological
                                               approve changes through the USQ                         would be changed by adding ‘‘updated                  facilities’’, and by adding ‘‘DOE’’ to the
                                               process.                                                or amended’’ to modify ‘‘safety basis’’,              reference to Hazard Category 1, 2, and
                                                  4. In proposed § 830.203 ‘‘Unreviewed                moving the word ‘‘existing’’ to before                3 nuclear facilities to match changes to
                                               safety question process,’’ current                      the phrase ‘‘Hazard Category 1, 2, or 3               definitions within § 830.3. Current ‘‘C.
                                               § 830.203(a) would be changed by                        DOE nuclear facility’’ to better match                Scope’’ Table 1 is proposed for deletion
                                               adding ‘‘DOE-approved’’ as a modifier                   the revised definition, and by deleting               for consistency with the proposal to
                                               to USQ, and by changing the word                        ‘‘in effect on October 10, 2000, or as                allow use of subsequent versions of
                                               ‘‘process’’ to ‘‘procedure’’. These                     approved by DOE at a later date’’ to                  DOE–STD–1027, since Table 1
                                               proposed changes are to clarify the                     reflect that all Hazard Category 1, 2, or             references the specific content of DOE–
                                               connection between references to the                    3 DOE nuclear facilities already operate              STD–1027–92, Change Notice 1,
                                               DOE-approved procedure in proposed                      within 10 CFR part 830. Current                       September 1997.
                                               § 830.203(a), § 830.203(b), and                         § 830.207(c) would be deleted, as DOE                    10. In proposed Appendix A to
                                               § 830.203(c). Current § 830.203(b) would                no longer has existing Hazard Category                Subpart B to 10 CFR part 830—General
                                               be deleted, since DOE no longer has                     1, 2, or 3 facilities operated outside of             Statement of Safety Basis Policy, current
                                               existing facilities operating outside of 10             10 CFR part 830. Current § 830.207(d)                 ‘‘E. Enforcement of Safety Basis
                                               CFR part 830. In the current                            would be redesignated as § 830.207(a)                 Requirements, 4.’’ would be changed by
                                               § 830.203(c), which is proposed to be                   and updated to reflect the changes in                 deleting the word ‘‘however’’ to
                                               redesignated as § 830.203(b), the word                  definitions in § 830.3. As a result, the              improve clarity.
                                               ‘‘new’’ has been proposed to be moved                   proposed § 830.207(a) would now read                     11. In proposed Appendix A to
                                               to match a proposed change in the                       as: ‘‘With respect to a new Hazard                    Subpart B to 10 CFR part 830—General
                                               definition of New Hazard Category 1, 2,                 Category 1, 2, or 3 DOE nuclear facility              Statement of Safety Basis Policy current
                                               and 3 nuclear facility, and ‘‘207(d)’’                  or a major modification to an existing                ‘‘F. Documented Safety Analysis, 3.’’
                                               would be changed to ‘‘207(a)’’ to reflect               Hazard Category 1, 2, or 3 DOE nuclear                would be changed by adding ‘‘as: (1)
                                               changes to § 830.207. Current                           facility, a contractor may not begin                  part of the initial submittal; (2) when
                                               § 830.203(d) would be redesignated as                   operation of the facility or modification             revisions are submitted as part of a
                                               § 830.203(c). Current § 830.203(e) would                prior to the issuance of a safety                     positive USQ or major modification; (3)
                                               be redesignated as § 830.203(d). Current                evaluation report in which DOE                        if DOE has reason to believe a portion
                                               § 830.203(f) would be redesignated as                   approves the safety basis for the facility            of the safety basis to be inadequate, or;
                                               § 830.203(e), ‘‘submit’’ would be                       or modification.’’                                    (4) if DOE has reason to believe a
                                               replaced by ‘‘provide’’, and                               8. In proposed Appendix A to Subpart               portion of the safety basis has
                                               ‘‘submissions’’ would be replaced by                    B to 10 CFR part 830—General                          substantially changed. DOE will review
                                               ‘‘submittal’’ to better reflect that the                Statement of Safety Basis Policy current              the DSA’’ to better define when and
                                               document is being given to DOE for                      ‘‘A. Introduction’’ would be modified by              why DOE would review a DSA. This
                                               review, but not for approval. Current                   replacing a reference to an outdated                  change is proposed to be consistent with
                                               § 830.203(g) would be redesignated as                   DOE Policy with a specific statement                  proposed changes to DOE’s requirement
                                               § 830.203(f), and the text would be                     that reflects current DOE policy and                  to annually approve the DSA. Current
                                               changed to read ‘‘initiated to meet                     would now read as follows, ‘‘This                     ‘‘F. Documented Safety Analysis, 3.’’
                                               paragraph (f)(1) of this section’’                      Appendix does not create any new                      would also be changed by adding ‘‘in
                                               consistent with citation changes in this                requirements and should be used                       the Safety Evaluation Report’’ to the end
                                               section.                                                consistently with DOE’s policy that                   of the last sentence in that section,
                                                  5. In proposed § 830.204                             work be conducted safely and efficiently              which currently reads, ‘‘A documented
                                               ‘‘Documented safety analysis,’’ current                 and in a manner that ensures protection               safety analysis must contain any
                                               § 830.204(a) would be updated by                        of workers, the public, and the                       conditions or changes required by
                                               changing ‘‘Table 2’’ to ‘‘Table 1’’ to                  environment.’’                                        DOE.’’ This change is proposed to
                                               reflect the deletion of Table 1 and re-                    9. In proposed Appendix A to Subpart               clarify how DOE directs conditions and
                                               numbering of subsequent tables.                         B to 10 CFR part 830—General                          changes required by DOE. Additionally,
                                                  6. In proposed § 830.206 ‘‘Preliminary               Statement of Safety Basis Policy current              Current ‘‘F. Documented Safety
                                               documented safety analysis,’’ current                   ‘‘C. Scope, 1.’’ would be changed by                  Analysis, 3.’’ would be changed by
                                               § 830.206 would be changed to read                      replacing the reference to ‘‘DOE–STD–                 adding the following sentences,
                                               ‘‘Prior to construction of a new Hazard                 1027–92 Change Notice 1, September                    ‘‘Generally, DOE’s review of the annual
                                               Category 1, 2, or 3 DOE nuclear facility                1997’’ with a general reference to DOE–               submittal may be limited to ensuring
                                               or a major modification to an existing                  STD–1027 to reflect the proposed                      that the results of USQs have been
                                               Hazard Category 1, 2, or 3 DOE nuclear                  change to allow successor versions of                 adequately incorporated into the DSA. If
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                                               facility, the contractor responsible for                DOE–STD–1027 to be used, the                          additional changes are proposed by the
                                               the design and construction of the new                  reference to ‘‘Table 1’’ would be deleted             contractor and included in the annual
                                               facility or major modification must:’’ To               to reflect the proposed deletion of Table             update that have not been previously
                                               reflect changes to the definitions in                   1. The proposed sentences now would                   approved by DOE or have not been
                                               § 830.3. Current § 830.206(b)(1) would                  read, ‘‘A contractor must establish and               evaluated as a part of the USQ process,
                                               be changed to add, ‘‘, or successor                     maintain a safety basis for a Hazard                  DOE must review and approve these
                                               document’’ as a modifier to ‘‘DOE Order                 Category 1, 2, or 3 DOE nuclear facility              changes. DOE has the authority to
                                               420.1, Facility Safety’’ to reflect the                 because these facilities have the                     review the safety basis at any time.’’


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                                               38986                Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Proposed Rules

                                               This proposed change is in support of                   Would be changed to update the                        them to the registration desk prior to the
                                               focusing DOE’s approval of changes in                   reference to DOE Guide 424.1–1B Chg 2,                meeting.
                                               the DSA to the incorporation of USQ’s                   to update the title of the referenced
                                                                                                                                                             IV. Regulatory Review
                                               or as DOE determines are necessary to                   guide to ‘‘Implementation Guide for Use
                                               maintain safe operations, rather than the               in Addressing Unreviewed Safety                       A. Review Under Executive Order 12866
                                               previous annual process. Current ‘‘F.                   Question Requirements,’’ to add ‘‘or                    This notice of proposed rulemaking
                                               Documented Safety Analysis, 4.’’ would                  successor document’’ to reflect the                   has been determined not to be a
                                               be changed by renumbering the                           ongoing updates to the current version                significant regulatory action under
                                               reference to ‘‘Table 2’’ to ‘‘Table 1’’ to              of the DOE guide, and by adding the                   Executive Order 12866, ‘‘Regulatory
                                               reflect the deletion of Table 1. Current                sentence, ‘‘The contractor is allowed to              Planning and Review,’’ 58 FR 51735
                                               ‘‘F. Documented Safety Analysis’’                       make editorial and format changes to its              (Oct. 4, 1993). Accordingly, this notice
                                               would be changed by changing the title                  USQ procedure while maintaining DOE                   of proposed rulemaking was not subject
                                               of ‘‘Table 2’’ to ‘‘Table 1’’ to reflect the            approval.’’ The additional sentence                   to review by the Office of Information
                                               deletion of Table 1. Current ‘‘F.                       wold be provided to better delineate                  and Regulatory Affairs of the Office of
                                               Documented Safety Analysis, 5.’’ would                  those aspects of the USQ process on                   Management and Budget.
                                               be changed by renumbering the                           which DOE approval focuses.
                                               reference to ‘‘Table 2’’ to ‘‘Table 1’’ to                 14. Throughout 10 CFR part 830, the                B. Review Under Executive Orders
                                               reflect the deletion of Table 1, by                     term ‘‘Hazard Category’’ would be                     13771 and 13777
                                               changing the reference to the definition                capitalized to improve consistency with                  On January 30, 2017, the President
                                               of nuclear facility to re-state the existing            the usage within the DOE regulatory                   issued Executive Order 13771,
                                               definition within § 830.3 instead of                    structure.                                            ‘‘Reducing Regulation and Controlling
                                               paraphrasing the definition, by
                                                                                                       III. Public Comment Procedures                        Regulatory Costs.’’ That Order stated the
                                               renumbering the reference to ‘‘Table 3’’
                                                                                                                                                             policy of the executive branch is to be
                                               to ‘‘Table 2’’ to reflect the deletion of               A. Written Comments                                   prudent and financially responsible in
                                               Table 1, and by replacing ‘‘specific
                                                                                                         Interested persons are invited to                   the expenditure of funds, from both
                                               nuclear facilities’’ with ‘‘terms’’ in
                                                                                                       participate in this proceeding by                     public and private sources. The Order
                                               reference to the content within Table 1.
                                                                                                       submitting data, views, or arguments.                 stated it is essential to manage the costs
                                               Current ‘‘F. Documented Safety
                                                                                                       Written comments should be submitted                  associated with the governmental
                                               Analysis’’ would be changed by
                                                                                                       to the address, and in the form,                      imposition of private expenditures
                                               renumbering the title of ‘‘Table 3’’ to
                                               ‘‘Table 2’’ to reflect the proposed                     indicated in the ADDRESSES section of                 required to comply with Federal
                                               deletion of Table 1 and changing the                    this notice of proposed rulemaking. To                regulations. This proposed rule is
                                               reference to ‘‘Table 2’’ to ‘‘Table 1’’ to              help DOE review the comments,                         expected to be an E.O. 13771
                                               reflect the proposed deletion of Table 1.               interested persons are asked to refer to              deregulatory action.
                                               Current ‘‘F. Documented Safety                          specific proposed rule provisions, if                    Additionally, on February 24, 2017,
                                               Analysis, 6.’’ would be changed to                      possible.                                             the President issued Executive Order
                                               delete the phrase ‘‘If construction begins                If you submit information that you                  13777, ‘‘Enforcing the Regulatory
                                               after December 11, 2000’’ and by adding                 believe to be exempt by law from public               Reform Agenda.’’ The Order required
                                               ‘‘or successor document’’ as a modifier                 disclosure, you should submit one                     the head of each agency designate an
                                               to ‘‘DOE Order 420.1, Facility Safety’’ to              complete copy, as well as one copy from               agency official as its Regulatory Reform
                                               reflect the ongoing updates to the                      which the information claimed to be                   Officer (RRO). Each RRO oversees the
                                               current version of the DOE order.                       exempt by law from public disclosure                  implementation of regulatory reform
                                                  12. In proposed Appendix A to                        has been deleted. DOE is responsible for              initiatives and policies to ensure that
                                               Subpart B to 10 CFR part 830—General                    the final determination with regard to                agencies effectively carry out regulatory
                                               Statement of Safety Basis Policy current                disclosure or nondisclosure of the                    reforms, consistent with applicable law.
                                               ‘‘G. Hazard Controls, 2.’’ would be                     information and for treating it                       Further, E.O. 13777 requires the
                                               changed to add ‘‘or successor                           accordingly under the DOE Freedom of                  establishment of a regulatory task force
                                               document’’ as a modifier to ‘‘DOE Order                 Information regulations at 10 CFR                     at each agency. The regulatory task force
                                               420.1, Facility Safety’’ to reflect the                 1004.11.                                              is required to make recommendations to
                                               ongoing updates to the current version                                                                        the agency head regarding the repeal,
                                                                                                       B. Public Meetings                                    replacement, or modification of existing
                                               of the DOE order. Current ‘‘G. Hazard
                                               Controls, 4.’’ would be changed to                        Public meetings will be held at the                 regulations, consistent with applicable
                                               update the reference to DOE Guide                       times, dates, and places indicated at the             law. At a minimum, each regulatory
                                               423.1–1B and by adding, ‘‘or successor                  start of the SUPPLEMENTARY INFORMATION                reform task force must attempt to
                                               document’’ to reflect the ongoing                       section of this notice of proposed                    identify regulations that:
                                               updates to the current version of the                   rulemaking. Any person who is                            (i) Eliminate jobs, or inhibit job
                                               DOE guide. Current ‘‘G. Hazard                          interested in making an oral                          creation;
                                               Controls, 4.’’ would be changed by                      presentation should make a phone                         (ii) Are outdated, unnecessary, or
                                               changing the reference to ‘‘Table 4’’ to                request to the person and telephone                   ineffective;
                                               ‘‘Table 3’’ to reflect the proposed                     number in the SUPPLEMENTARY                              (iii) Impose costs that exceed benefits;
                                               deletion of Table 1. Current ‘‘G. Hazard                INFORMATION section by 4:30 p.m. on the                  (iv) Create a serious inconsistency or
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                                               Controls’’ would be changed by                          date specified for making such requests.              otherwise interfere with regulatory
                                               changing the title of the table from                    The person should provide a daytime                   reform initiatives and policies;
                                               ‘‘Table 4’’ to ‘‘Table 3’’ to reflect the               phone number where he or she can be                      (v) Are inconsistent with the
                                               proposed deletion of Table 1.                           reached. Each oral presentation will be               requirements of Information Quality
                                                  13. In proposed Appendix A to                        limited to 20 minutes. Persons making                 Act, or the guidance issued pursuant to
                                               Subpart B to 10 CFR part 830—General                    an oral presentation are requested to                 that Act, in particular those regulations
                                               Statement of Safety Basis Policy current                bring 3 copies of their prepared                      that rely in whole or in part on data,
                                               ‘‘H. Unreviewed Safety Questions, 3.’’                  statement to the meeting and submit                   information, or methods that are not


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                                                                    Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Proposed Rules                                           38987

                                               publicly available or that are                          Business Administration pursuant to 5                 the aggregate, or by the private sector of
                                               insufficiently transparent to meet the                  U.S.C. 605(b).                                        $100 million or more in any one year
                                               standard for reproducibility; or                                                                              (adjusted annually for inflation), section
                                                                                                       D. Paperwork Reduction Act
                                                  (vi) Derive from or implement                                                                              202 of UMRA requires a Federal agency
                                               Executive Orders or other Presidential                    The information collection necessary                to publish a written statement that
                                               directives that have been subsequently                  to administer DOE’s nuclear safety                    estimates the resulting costs, benefits,
                                               rescinded or substantially modified.                    program under 10 CFR part 830 is                      and other effects on the national
                                                  DOE concludes that this final rule is                subject to OMB approval under the                     economy. (2 U.S.C. 1532(a), (b)) UMRA
                                               consistent with the directives set forth                Paperwork Reduction Act, 44 U.S.C.                    also requires a Federal agency to
                                               in these executive orders. This                         3501 et seq. The information collection               develop an effective process to permit
                                               provisions in this proposed rule are                    provisions of this rule are not                       timely input by elected officers of State,
                                               intended, as described in section II, to                substantially different from those                    local, and Tribal governments on a
                                               enhance operational efficiency while                    contained in DOE contracts with DOE                   ‘‘significant intergovernmental
                                               maintaining robust safety performance                   prime contractors covered by this rule                mandate,’’ and requires an agency plan
                                               at DOE nuclear facilities.                              and were previously approved by the                   for giving notice and opportunity for
                                                                                                       Office of Management and Budget                       timely input to potentially affected
                                               C. Regulatory Flexibility Act                           (OMB) and under OMB Control No.                       small governments before establishing
                                                  The Regulatory Flexibility Act (5                    1910–0300. Public reporting burden for                any requirements that might
                                               U.S.C. 601 et seq.) requires preparation                the certification is estimated to average             significantly or uniquely affect them. On
                                               of an initial regulatory flexibility                    1.91 hours per response, including the                March 18, 1997, DOE published a
                                               analysis for any rule that by law must                  time for reviewing instructions,                      statement of policy on its process for
                                               be proposed for public comment, unless                  searching existing data sources,                      intergovernmental consultation under
                                               the agency certifies that the rule, if                  gathering and maintaining the data                    UMRA. 62 FR 12820. (This policy is
                                               promulgated, will not have a significant                needed, and completing and reviewing                  also available at http://energy.gov/gc/
                                               economic impact on a substantial                        the collection of information.                        office-general-counsel.) DOE examined
                                                                                                         Notwithstanding any other provision                 this proposed rule according to UMRA
                                               number of small entities. As required by
                                                                                                       of the law, no person is required to                  and its statement of policy and has
                                               Executive Order 13272, ‘‘Proper
                                                                                                       respond to, nor shall any person be                   tentatively determined that the rule
                                               Consideration of Small Entities in
                                                                                                       subject to a penalty for failure to comply            contains neither an intergovernmental
                                               Agency Rulemaking,’’ 67 FR 53461
                                                                                                       with, a collection of information subject             mandate, nor a mandate that may result
                                               (Aug. 16, 2002), DOE published
                                                                                                       to the requirements of the PRA, unless                in the expenditure by State, local, and
                                               procedures and policies on February 19,
                                                                                                       that collection of information displays a             Tribal government, in the aggregate, or
                                               2003, to ensure that the potential
                                                                                                       currently valid OMB Control Number.                   by the private sector, of $100 million or
                                               impacts of its rules on small entities are
                                               properly considered during the                          E. National Environmental Policy Act                  more in any year. Accordingly, no
                                               rulemaking process. 68 FR 7990. DOE                                                                           further assessment or analysis is
                                                                                                          DOE has determined that this                       required under UMRA.
                                               has made its procedures and policies                    proposed rule is covered under the
                                               available on the Office of the General                  Categorical Exclusion in DOE’s National               G. Treasury and General Government
                                               Counsel’s website (http://energy.gov/gc/                Environmental Policy Act regulations at               Appropriations Act, 1999
                                               office-general-counsel).                                paragraph A.5 of Appendix A to Subpart                   Section 654 of the Treasury and
                                                  DOE has reviewed this proposed rule                  D, 10 CFR part 1021, which applies to                 General Government Appropriations
                                               under the provisions of the Regulatory                  rulemaking that interprets or amends an               Act, 1999, 5 U.S.C. 601 note, requires
                                               Flexibility Act and the procedures and                  existing rule or regulation without                   Federal agencies to issue a Family
                                               policies published on February 19,                      changing the environmental effect of the              Policymaking Assessment for any
                                               2003. The proposed rule would                           rule or regulation that is being amended.             proposed rule that may affect family
                                               incorporate the experience of more than                 The proposed rule would amend DOE’s                   wellbeing. While this proposed rule
                                               a decade of implementation to improve                   regulations by removing duplicative                   would apply to individuals who may be
                                               the effectiveness of the DOE nuclear                    approval requirements, updating                       members of a family, the rule would not
                                               safety regulatory framework while                       definitions, and increasing the                       have any impact on the autonomy or
                                               maintaining safety performance.                         efficiency of internal processes. These               integrity of the family as an institution.
                                               Requirements that are considered                        proposed amendments are primarily                     Accordingly, DOE has concluded that it
                                               duplicative or of little value have been                procedural and would not change the                   is not necessary to prepare a Family
                                               proposed to be removed. DOE is                          environmental effect of 10 CFR part 830.              Policymaking Assessment.
                                               proposing four key changes in this                      Accordingly, neither an environmental
                                               proposed rule, as described in II.                                                                            H. Executive Order 13132
                                                                                                       assessment nor an environmental
                                               Discussion of Proposed Rule, A.                         impact statement is required.                            Executive Order 13132, ‘‘Federalism,’’
                                               Discussion of Key Proposed Changes.                                                                           64 FR 43255 (Aug. 4, 1999), imposes
                                                  The changes in this proposed rule are                F. Unfunded Mandates Reform Act of                    certain requirements on agencies
                                               all expected to reduce burden on                        1995                                                  formulating and implementing policies
                                               affected DOE contractors. On this basis,                  Title II of the Unfunded Mandates                   or regulations that preempt State law or
                                               DOE certifies that this proposed rule                   Reform Act of 1995 (UMRA) requires                    that have federalism implications.
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                                               would not have a significant economic                   each Federal agency to assess the effects             Agencies are required to examine the
                                               impact on a substantial number of small                 of Federal regulatory actions on State,               constitutional and statutory authority
                                               entities. Accordingly, DOE has not                      local, and Tribal governments and the                 supporting any action that would limit
                                               prepared a regulatory flexibility analysis              private sector. Public Law 104–4, sec.                the policymaking discretion of the
                                               for this rulemaking. DOE’s certification                201 (codified at 2 U.S.C. 1531). For                  States and carefully assess the necessity
                                               and supporting statement of factual                     regulatory actions likely to result in a              for such actions. DOE has examined this
                                               basis will be provided to the Chief                     rule that may cause the expenditure by                proposed rule and has determined that
                                               Counsel for Advocacy of the Small                       State, local, and Tribal governments, in              it would not preempt State law and


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                                               38988                Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Proposed Rules

                                               would not have a substantial direct                     concluded that it is consistent with                  830.3     Definitions.
                                               effect on the States, on the relationship               applicable policies in those guidelines.              830.4     General requirements.
                                               between the national government and                                                                           830.5     Enforcement.
                                                                                                       K. Executive Order 13211                              830.6     Recordkeeping.
                                               the States, or on the distribution of
                                                                                                          Executive Order 13211, ‘‘Actions                   830.7     Graded approach.
                                               power and responsibilities among the
                                               various levels of government. No further                Concerning Regulations That                           Subpart A—Quality Assurance
                                               action is required by Executive Order                   Significantly Affect Energy Supply,                   Requirements
                                               13132.                                                  Distribution, or Use,’’ 66 FR 28355 (May              830.120 Scope.
                                                                                                       22, 2001), requires Federal agencies to               830.121 Quality Assurance Program (QAP).
                                               I. Executive Order 12988                                prepare and submit to the Office of                   830.122 Quality assurance criteria.
                                                  With respect to the review of existing               Information and Regulatory Affairs                    Subpart B—Safety Basis Requirements
                                               regulations and the promulgation of                     (OIRA) a Statement of Energy Effects for
                                                                                                       any proposed significant energy action.               830.200 Scope.
                                               new regulations, section 3(a) of                                                                              830.201 Performance of work.
                                               Executive Order 12988, ‘‘Civil Justice                  A ‘‘significant energy action’’ is defined            830.202 Safety basis.
                                               Reform,’’ 61 FR 4729 (Feb. 7, 1996),                    as any action by an agency that                       830.203 Unreviewed safety question
                                               imposes on Executive agencies the                       promulgated or is expected to lead to                     process.
                                               general duty to adhere to the following                 promulgation of a final rule, and that:               830.204 Documented safety analysis.
                                               requirements: (1) Eliminate drafting                    (1) Is a significant regulatory action                830.205 Technical safety requirements.
                                               errors and ambiguity; (2) write                         under Executive Order 12866, or any                   830.206 Preliminary documented safety
                                                                                                       successor order; and (2) is likely to have                analysis.
                                               regulations to minimize litigation; and                                                                       830.207 DOE approval of safety basis.
                                               (3) provide a clear legal standard for                  a significant adverse effect on the
                                                                                                       supply, distribution, or use of energy, or            Appendix A to Subpart B to Part 830—
                                               affected conduct rather than a general                                                                            General Statement of Safety Basis Policy
                                               standard and promote simplification                     (3) is designated by the Administrator of
                                                                                                       OIRA as a significant energy action. For                 Authority: 42 U.S.C. 2201; 42 U.S.C. 7101
                                               and burden reduction. With regard to                                                                          et seq.; and 50 U.S.C. 2401 et seq.
                                               the review required by section 3(a),                    any proposed significant energy action,
                                               section 3(b) of Executive Order 12988                   the agency must give a detailed                       § 830.1    Scope.
                                               specifically requires that Executive                    statement of any adverse effects on                     This part governs the conduct of DOE
                                               agencies make every reasonable effort to                energy supply, distribution, or use                   contractors, DOE personnel, and other
                                               ensure that the regulation: (1) Clearly                 should the proposal be implemented,                   persons conducting activities (including
                                               specifies the preemptive effect, if any;                and of reasonable alternatives to the                 providing items and services) that affect,
                                               (2) clearly specifies any effect on                     action and their expected benefits on                 or may affect, the safety of DOE nuclear
                                               existing Federal law or regulation; (3)                 energy supply, distribution, and use.                 facilities.
                                               provides a clear legal standard for                     This regulatory action has been
                                               affected conduct while promoting                        determined to not be a significant                    § 830.2    Exclusions.
                                               simplification and burden reduction; (4)                regulatory action, and it would not have                This part does not apply to:
                                               specifies the retroactive effect, if any; (5)           an adverse effect on the supply,                        (a) Activities that are regulated
                                               adequately defines key terms; and (6)                   distribution, or use of energy. Thus, this            through a license by the Nuclear
                                               addresses other important issues                        action is not a significant energy action.            Regulatory Commission (NRC) or a State
                                               affecting clarity and general                           Accordingly, DOE has not prepared a                   under an Agreement with the NRC,
                                               draftsmanship under any guidelines                      Statement of Energy Effects.                          including activities certified by the NRC
                                               issued by the Attorney General. Section                 V. Approval of the Office of the                      under section 1701 of the Atomic
                                               3(c) of Executive Order 12988 requires                  Secretary                                             Energy Act (Act);
                                               Executive agencies to review regulations                                                                        (b) Activities conducted under the
                                                                                                         The Secretary of Energy has approved                authority of the Director, Naval Nuclear
                                               in light of applicable standards in
                                                                                                       the publication of this proposed rule.                Propulsion, pursuant to Executive Order
                                               section 3(a) and section 3(b) to
                                               determine whether they are met or it is                 List of Subjects in 10 CFR Part 830                   12344, as set forth in Public Law 106–
                                               unreasonable to meet one or more of                                                                           65;
                                                                                                         Administrative practice and                           (c) Transportation activities which are
                                               them. DOE has completed the required                    procedure, DOE contracts, Environment,
                                               review and determined that, to the                                                                            regulated by the Department of
                                                                                                       Federal buildings and facilities,                     Transportation;
                                               extent permitted by law, this proposed                  Government contracts, Nuclear                           (d) Activities conducted under the
                                               rule meets the relevant standards of                    materials, Nuclear power plants and                   Nuclear Waste Policy Act of 1982, as
                                               Executive Order 12988.                                  reactors, Nuclear safety, Penalties,                  amended, and any facility identified
                                               J. Treasury and General Government                      Public health, Reporting and                          under section 202(5) of the Energy
                                               Appropriations Act, 2001                                recordkeeping requirements, and Safety.               Reorganization Act of 1974, as
                                                                                                         Issued in Washington, DC, on August 1,              amended; and
                                                  The Treasury and General                             2018.                                                   (e) Activities related to the launch
                                               Government Appropriations Act, 2001,                    Dan Brouillette,                                      approval and actual launch of nuclear
                                               44 U.S.C. 3516 note, provides for                                                                             energy systems into space.
                                                                                                       Deputy Secretary of Energy.
                                               agencies to review most disseminations
                                               of information to the public under                        For the reasons stated in the                       § 830.3    Definitions.
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                                               guidelines established by each agency                   preamble, DOE proposes to revise 10                     (a) The following definitions apply to
                                               pursuant to general guidelines issued by                CFR part 830 to read as follows:                      this part:
                                               OMB. OMB’s guidelines were published                                                                            Administrative controls means the
                                               at 67 FR 8452 (Feb. 22, 2002), and                      PART 830—NUCLEAR SAFETY                               provisions relating to organization and
                                               DOE’s guidelines were published at 67                   MANAGEMENT                                            management, procedures,
                                               FR 62446 (Oct. 7, 2002). DOE has                        Sec.                                                  recordkeeping, assessment, and
                                               reviewed this proposed rule under the                   830.1    Scope.                                       reporting necessary to ensure safe
                                               OMB and DOE guidelines and has                          830.2    Exclusions.                                  operation of a facility.


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                                                                    Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Proposed Rules                                            38989

                                                  Bases appendix means an appendix                        Hazard Category 1, 2, and 3 DOE                    or work practices would release the
                                               that describes the basis of the limits and              nuclear facilities means nuclear                      remaining fixed radioactivity or
                                               other requirements in technical safety                  facilities that meet the criteria for their           activation components at levels that
                                               requirements.                                           respective hazard category consistent                 would prudently require the use of
                                                  Critical assembly means special                      with the provisions of DOE–STD–1027–                  active safety systems, structures, or
                                               nuclear devices designed and used to                    92, Change Notice 1, or successor                     components to prevent or mitigate a
                                               sustain nuclear reactions, which may be                 document. Hazard Category 1, 2, and 3                 release of radioactive materials.
                                               subject to frequent core and lattice                    DOE nuclear facilities are required to                   Major modification means a
                                               configuration change and which                          have safety bases established in                      modification to a DOE nuclear facility
                                               frequently may be used as mockups of                    accordance with Subpart B of this part.               that substantially changes the existing
                                               reactor configurations.                                 Hazard categories are based on their                  safety basis for the facility.
                                                  Criticality means the condition in                   radioactive material inventories and the                 New Hazard Category 1, 2, and 3 DOE
                                               which a nuclear fission chain reaction                  potential consequences to the public,                 nuclear facility means a Hazard
                                               becomes self-sustaining.                                workers, and the environment. Hazard                  Category 1, 2, or 3 DOE nuclear facility
                                                  Design features means the design                     Category 1 represents the highest                     that is in design or under construction
                                               features of a nuclear facility specified in             potential consequence and Hazard                      that does not yet have a DOE approved
                                               the technical safety requirements that, if              Category 3 represents the lowest                      safety basis.
                                               altered or modified, would have a                       potential consequence of the facilities                  Nonreactor nuclear facility means
                                               significant effect on safe operation.                   required to establish safety bases.                   those facilities, activities or operations
                                                  Document means recorded                                 Hazard controls means measures to                  that involve, or will involve, radioactive
                                               information that describes, specifies,                  eliminate, limit, or mitigate hazards to
                                               reports, certifies, requires, or provides                                                                     and/or fissionable materials in such
                                                                                                       workers, the public, or the environment,              form and quantity that a nuclear or a
                                               data or results.                                        including
                                                  Documented safety analysis means a                                                                         nuclear explosive hazard potentially
                                                                                                          (i) Physical, design, structural, and              exists to workers, the public, or the
                                               documented analysis of the extent to                    engineering features;
                                               which a nuclear facility can be operated                                                                      environment, but does not include
                                                                                                          (ii) Safety structures, systems, and               accelerators and their operations and
                                               safely with respect to workers, the                     components;
                                               public, and the environment, including                                                                        does not include activities involving
                                                                                                          (iii) Safety management programs;                  only incidental use and generation of
                                               a description of the conditions, safe                      (iv) Technical safety requirements;
                                               boundaries, and hazard controls that                                                                          radioactive materials or radiation such
                                                                                                       and
                                               provide the basis for ensuring safety.                     (v) Other controls necessary to                    as check and calibration sources, use of
                                                  Environmental restoration activities                 provide adequate protection from                      radioactive sources in research and
                                               means the process(es) by which                          hazards.                                              experimental and analytical laboratory
                                               contaminated sites and facilities are                      Item is an all-inclusive term used in              activities, electron microscopes, and X-
                                               identified and characterized and by                     place of any of the following:                        ray machines.
                                               which contamination is contained,                       Appurtenance, assembly, component,                       Nuclear facility means a reactor or a
                                               treated, or removed and disposed.                       equipment, material, module, part,                    nonreactor nuclear facility where an
                                                  Fissionable materials means a nuclide                product, structure, subassembly,                      activity is conducted for or on behalf of
                                               capable of sustaining a neutron-induced                 subsystem, system, unit, or support                   DOE and includes any related area,
                                               chain reaction (e.g., uranium-233,                      systems.                                              structure, facility, or activity to the
                                               uranium-235, plutonium-238,                                Limiting conditions for operation                  extent necessary to ensure proper
                                               plutonium-239, plutonium-241,                           means the limits that represent the                   implementation of the requirements
                                               neptunium-237, americium-241, and                       lowest functional capability or                       established by this Part.
                                               curium-244).                                            performance level of safety structures,                  Operating limits means those limits
                                                  Graded approach means the process                    systems, and components required for                  required to ensure the safe operation of
                                               of ensuring that the level of analysis,                 safe operations.                                      a nuclear facility, including limiting
                                               documentation, and actions used to                         Limiting control settings means the                control settings and limiting conditions
                                               comply with a requirement in this part                  settings on safety systems that control               for operation.
                                               are commensurate with:                                  process variables to prevent exceeding a                 Preliminary documented safety
                                                  (i) The relative importance to safety,               safety limit.                                         analysis means documentation prepared
                                               safeguards, and security;                                  Low-level residual fixed radioactivity             in connection with the design and
                                                  (ii) The magnitude of any hazard                     means the remaining radioactivity                     construction of a new Hazard Category
                                               involved;                                               following reasonable efforts to remove                1, 2, or 3 DOE nuclear facility or a major
                                                  (iii) The life cycle stage of a facility;                                                                  modification to an existing Hazard
                                                  (iv) The programmatic mission of a                   radioactive systems, components, and
                                                                                                       stored materials. The remaining                       Category 1, 2, or 3 DOE nuclear facility
                                               facility;
                                                  (v) The particular characteristics of a              radioactivity is composed of surface                  that provides a reasonable basis for the
                                               facility;                                               contamination that is fixed following                 preliminary conclusion that the nuclear
                                                  (vi) The relative importance of                      chemical cleaning or some similar                     facility can be operated safely through
                                               radiological and nonradiological                        process; a component of surface                       the consideration of factors such as:
                                               hazards; and                                            contamination that can be picked up by                   (i) The nuclear safety design criteria
                                                  (vii) Any other relevant factor.                     smears; or activated materials within                 to be satisfied;
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                                                  Hazard means a source of danger (i.e.,               structures. The radioactivity can be                     (ii) A safety analysis that derives
                                               material, energy source, or operation)                  characterized as low-level if the                     aspects of design that are necessary to
                                               with the potential to cause illness,                    smearable radioactivity is less than the              satisfy the nuclear safety design criteria;
                                               injury, or death to a person or damage                  values defined for removable                          and
                                               to a facility or to the environment                     contamination by 10 CFR part 835,                        (iii) An initial listing of the safety
                                               (without regard to the likelihood or                    Appendix D, Surface Contamination                     management programs that must be
                                               credibility of accident scenarios or                    Values, and the hazard analysis results               developed to address operational safety
                                               consequence mitigation).                                show that no credible accident scenario               considerations.


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                                               38990                Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Proposed Rules

                                                  Process means a series of actions that                  Safety management program means a                    Unreviewed Safety Question (USQ)
                                               achieves an end or result.                              program designed to ensure a facility is              means a situation where:
                                                  Quality means the condition achieved                 operated in a manner that adequately                    (i) The probability of the occurrence
                                               when an item, service, or process meets                 protects workers, the public, and the                 or the consequences of an accident or
                                               or exceeds the user’s requirements and                  environment by covering a topic such                  the malfunction of equipment important
                                               expectations.                                           as: Quality assurance; maintenance of                 to safety previously evaluated in the
                                                  Quality assurance means all those                    safety systems; personnel training;                   documented safety analysis could be
                                               actions that provide confidence that                    conduct of operations; inadvertent                    increased;
                                               quality is achieved.                                    criticality protection; emergency                       (ii) The possibility of an accident or
                                                  Quality Assurance Program (QAP)                      preparedness; fire protection; waste                  malfunction of a different type than any
                                               means the overall program or                            management; or radiological protection                evaluated previously in the documented
                                               management system established to                        of workers, the public, and the                       safety analysis could be created; or
                                               assign responsibilities and authorities,                environment.                                            (iii) The documented safety analysis
                                               define policies and requirements, and                      Safety management system means an                  may not be bounding or may be
                                               provide for the performance and                         integrated safety management system                   otherwise inadequate.
                                               assessment of work.                                     established consistent with 48 CFR
                                                                                                       970.5223–1, Integration of environment,                 Unreviewed Safety Question process
                                                  Reactor means any apparatus that is
                                                                                                       safety, and health into work planning                 means the mechanism for keeping a
                                               designed or used to sustain nuclear
                                                                                                       and execution.                                        safety basis current by reviewing
                                               chain reactions in a controlled manner
                                                                                                                                                             potential unreviewed safety questions,
                                               such as research, test, and power                          Safety significant structures, systems,
                                                                                                                                                             reporting unreviewed safety questions
                                               reactors, and critical and pulsed                       and components means the structures,
                                                                                                                                                             to DOE, and obtaining approval from
                                               assemblies and any assembly that is                     systems, and components which are not
                                                                                                                                                             DOE prior to taking any action that
                                               designed to perform subcritical                         designated as safety class structures,
                                                                                                                                                             involves an unreviewed safety question.
                                               experiments that could potentially reach                systems, and components, but whose
                                               criticality; and, unless modified by                    preventive or mitigative function is a                  Use and application provisions means
                                               words such as containment, vessel, or                   major contributor to defense in depth                 the basic instructions for applying
                                               core, refers to the entire facility,                    and/or worker safety as determined                    technical safety requirements.
                                               including the housing, equipment and                    from safety analyses.                                   (b) Terms defined in the Act or in 10
                                               associated areas devoted to the                            Safety structures, systems, and                    CFR part 820 and not defined in this
                                               operation and maintenance of one or                     components means both safety class                    section of the rule are to be used
                                               more reactor cores.                                     structures, systems, and components                   consistent with the meanings given in
                                                  Record means a completed document                    and safety significant structures,                    the Act or in 10 CFR part 820.
                                               or other media that provides objective                  systems, and components.                              § 830.4    General requirements.
                                               evidence of an item, service, or process.                  Service means the performance of
                                                  Safety basis means the documented                    work, such as design, manufacturing,                    (a) No person may take or cause to be
                                               safety analysis and hazard controls that                construction, fabrication, assembly,                  taken any action inconsistent with the
                                               provide reasonable assurance that a                     decontamination, environmental                        requirements of this part.
                                               DOE nuclear facility can be operated                    restoration, waste management,                          (b) A contractor responsible for a
                                               safely in a manner that adequately                      laboratory sample analyses, inspection,               nuclear facility must ensure
                                               protects workers, the public, and the                   nondestructive examination/testing,                   implementation of, and compliance
                                               environment.                                            environmental qualification, equipment                with, the requirements of this part.
                                                  Safety class structures, systems, and                qualification, repair, installation, or the             (c) The requirements of this part must
                                               components means the structures,                        like.                                                 be implemented in a manner that
                                               systems, or components, including                          Surveillance requirements means                    provides reasonable assurance of
                                               portions of process systems, whose                      requirements relating to test, calibration,           adequate protection of workers, the
                                               preventive or mitigative function is                    or inspection to ensure that the                      public, and the environment from
                                               necessary to limit radioactive hazardous                necessary operability and quality of                  adverse consequences, taking into
                                               material exposure to the public, as                     safety structures, systems, and                       account the work to be performed and
                                               determined from safety analyses.                        components and their support systems                  the associated hazards.
                                                  Safety evaluation report means the                   required for safe operations are                        (d) If there is no contractor for a DOE
                                               report prepared by DOE to document:                     maintained, that facility operation is                nuclear facility, DOE must ensure
                                                  (i) The sufficiency of the documented                within safety limits, and that limiting               implementation of, and compliance
                                               safety analysis for a Hazard Category 1,                control settings and limiting conditions              with, the requirements of this part.
                                               2, or 3 DOE nuclear facility;                           for operation are met.
                                                  (ii) The extent to which a contractor                   Technical safety requirements (TSRs)               § 830.5    Enforcement.
                                               has satisfied the requirements of                       means the limits, controls, and related                 The requirements in this part are DOE
                                               Subpart B of this part; and                             actions that establish the specific                   Nuclear Safety Requirements and are
                                                  (iii) The basis for approval by DOE of               parameters and requisite actions for the              subject to enforcement by all
                                               the safety basis for the facility,                      safe operation of a nuclear facility and              appropriate means, including the
                                               including any conditions for approval.                  include, as appropriate for the work and              imposition of civil and criminal
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                                                  Safety limits means the limits on                    the hazards identified in the                         penalties in accordance with the
                                               process variables associated with those                 documented safety analysis for the                    provisions of 10 CFR part 820.
                                               safety class physical barriers, generally               facility: Safety limits, operating limits,
                                               passive, that are necessary for the                     surveillance requirements,                            § 830.6    Recordkeeping.
                                               intended facility function and that are                 administrative and management                           A contractor must maintain complete
                                               required to guard against the                           controls, use and application                         and accurate records as necessary to
                                               uncontrolled release of radioactive                     provisions, and design features, as well              substantiate compliance with the
                                               materials.                                              as a bases appendix.                                  requirements of this part.


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                                                                    Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Proposed Rules                                            38991

                                               § 830.7   Graded approach.                              § 830.122    Quality assurance criteria.              groups other than those who performed
                                                 Where appropriate, a contractor must                     The QAP must address the following                 the work.
                                               use a graded approach to implement the                  management, performance, and                             (5) Verify or validate work before
                                               requirements of this part, document the                 assessment criteria:                                  approval and implementation of the
                                               basis of the graded approach used, and                     (a) Criterion 1—Management/                        design.
                                               submit that documentation to DOE. The                   Program. (1) Establish an organizational                 (g) Criterion 7—Performance/
                                               graded approach may not be used in                      structure, functional responsibilities,               Procurement. (1) Procure items and
                                               implementing the unreviewed safety                      levels of authority, and interfaces for               services that meet established
                                               question (USQ) process or in                            those managing, performing, and                       requirements and perform as specified.
                                               implementing technical safety                           assessing the work.                                      (2) Evaluate and select prospective
                                                                                                          (2) Establish management processes,                suppliers on the basis of specified
                                               requirements.
                                                                                                       including planning, scheduling, and                   criteria.
                                               Subpart A—Quality Assurance                             providing resources for the work.                        (3) Establish and implement processes
                                               Requirements                                               (b) Criterion 2—Management/                        to ensure that approved suppliers
                                                                                                       Personnel Training and Qualification.                 continue to provide acceptable items
                                               § 830.120   Scope.                                      (1) Train and qualify personnel to be                 and services.
                                                                                                       capable of performing their assigned                     (h) Criterion 8—Performance/
                                                 This subpart establishes quality
                                                                                                       work.                                                 Inspection and Acceptance Testing. (1)
                                               assurance requirements for contractors                     (2) Provide continuing training to
                                               conducting activities, including                                                                              Inspect and test specified items,
                                                                                                       personnel to maintain their job                       services, and processes using
                                               providing items or services that affect,                proficiency.
                                               or may affect, nuclear safety of DOE                                                                          established acceptance and performance
                                                                                                          (c) Criterion 3—Management/Quality
                                               nuclear facilities.                                                                                           criteria.
                                                                                                       Improvement. (1) Establish and
                                                                                                                                                                (2) Calibrate and maintain equipment
                                               § 830.121   Quality Assurance Program                   implement processes to detect and
                                                                                                       prevent quality problems.                             used for inspections and tests.
                                               (QAP).                                                                                                           (i) Criterion 9—Assessment/
                                                                                                          (2) Identify, control, and correct
                                                  (a) Contractors conducting activities,               items, services, and processes that do                Management Assessment. Ensure
                                               including providing items or services,                  not meet established requirements.                    managers assess their management
                                               that affect, or may affect, the nuclear                    (3) Identify the causes of problems                processes and identify and correct
                                               safety of DOE nuclear facilities must                   and work to prevent recurrence as a part              problems that hinder the organization
                                               conduct work in accordance with the                     of correcting the problem.                            from achieving its objectives.
                                               Quality Assurance criteria in § 830.122.                   (4) Review item characteristics,                      (j) Criterion 10—Assessment/
                                                  (b) The contractor responsible for a                 process implementation, and other                     Independent Assessment. (1) Plan and
                                               DOE nuclear facility must:                              quality-related information to identify               conduct independent assessments to
                                                                                                       items, services, and processes needing                measure item and service quality, to
                                                  (1) Submit a QAP to DOE for approval
                                                                                                       improvement.                                          measure the adequacy of work
                                               and regard the QAP as approved 90 days
                                                                                                          (d) Criterion 4—Management/                        performance, and to promote
                                               after submittal, unless it is approved or
                                                                                                       Documents and Records. (1) Prepare,                   improvement.
                                               rejected by DOE at an earlier date.
                                                                                                       review, approve, issue, use, and revise                  (2) Establish sufficient authority, and
                                                  (2) Modify the QAP as directed by                    documents to prescribe processes,                     freedom from line management, for the
                                               DOE.                                                    specify requirements, or establish                    group performing independent
                                                  (3) Annually submit any changes to                   design.                                               assessments.
                                               the DOE-approved QAP to DOE for                            (2) Specify, prepare, review, approve,                (3) Ensure persons who perform
                                               approval. Justify in the submittal why                  and maintain records.                                 independent assessments are
                                               the changes continue to satisfy the                        (e) Criterion 5—Performance/Work                   technically qualified and knowledgeable
                                               quality assurance requirements.                         Processes. (1) Perform work consistent                in the areas to be assessed.
                                                  (4) Conduct work in accordance with                  with technical standards, administrative
                                               the QAP.                                                controls, and other hazard controls                   Subpart B—Safety Basis Requirements
                                                                                                       adopted to meet regulatory or contract
                                                  (c) The QAP must:                                    requirements, using approved                          § 830.200   Scope.
                                                  (1) Describe how the quality                         instructions, procedures, or other                      This Subpart establishes safety basis
                                               assurance criteria of § 830.122 are                     appropriate means.                                    requirements for Hazard Category 1, 2,
                                               satisfied.                                                 (2) Identify and control items to                  and 3 DOE nuclear facilities.
                                                  (2) Integrate the quality assurance                  ensure their proper use.
                                                                                                          (3) Maintain items to prevent their                § 830.201   Performance of work.
                                               criteria with the Safety Management
                                               System, or describe how the quality                     damage, loss, or deterioration.                         A contractor must perform work in
                                               assurance criteria apply to the Safety                     (4) Calibrate and maintain equipment               accordance with the DOE-approved
                                               Management System.                                      used for process monitoring or data                   safety basis for a Hazard Category 1, 2,
                                                                                                       collection.                                           or 3 DOE nuclear facility and, in
                                                  (3) Use voluntary consensus standards                   (f) Criterion 6—Performance/Design.                particular, with the hazard controls that
                                               in its development and implementation,                  (1) Design items and processes using                  ensure adequate protection of workers,
                                               where practicable and consistent with                   sound engineering/scientific principles               the public, and the environment.
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                                               contractual and regulatory                              and appropriate standards.
                                               requirements, and identify the standards                   (2) Incorporate applicable                         § 830.202   Safety basis.
                                               used.                                                   requirements and design bases in design                 (a) The contractor responsible for a
                                                  (4) Describe how the contractor                      work and design changes.                              Hazard Category 1, 2, or 3 DOE nuclear
                                               responsible for the nuclear facility                       (3) Identify and control design                    facility must establish and maintain the
                                               ensures that subcontractors and                         interfaces.                                           safety basis for the facility.
                                               suppliers satisfy the criteria of                          (4) Verify or validate the adequacy of               (b) In establishing the safety basis for
                                               § 830.122.                                              design products using individuals or                  a Hazard Category 1, 2, or 3 DOE


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                                               38992                Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Proposed Rules

                                               nuclear facility, the contractor                        analysis potentially may not be                       the process for maintaining the hazard
                                               responsible for the facility must:                      bounding or may be otherwise                          controls current at all times and
                                                 (1) Define the scope of the work to be                inadequate.                                           controlling their use;
                                               performed;                                                (d) A contractor responsible for a                     (5) Define the characteristics of the
                                                 (2) Identify and analyze the hazards                  Hazard Category 1, 2, or 3 DOE nuclear                safety management programs necessary
                                               associated with the work;                               facility must obtain DOE approval prior               to ensure the safe operation of the
                                                 (3) Categorize the facility consistent                to taking any action determined to                    facility, including (where applicable)
                                               with DOE–STD–1027–92 (‘‘Hazard                          involve a USQ.                                        quality assurance, procedures,
                                               Categorization and Accident Analysis                      (e) The contractor responsible for a                maintenance, personnel training,
                                               Techniques for compliance with DOE                      Hazard Category 1, 2, or 3 DOE nuclear                conduct of operations, emergency
                                               Order 5480.23, Nuclear Safety Analysis                  facility must annually provide to DOE a               preparedness, fire protection, waste
                                               Reports,’’ Change Notice 1, September                   summary of the USQ determinations                     management, and radiation protection;
                                               1997), or successor document;                           performed since the prior submittal.                  and
                                                 (4) Prepare a documented safety                         (f) If a contractor responsible for a                  (6) With respect to a nonreactor
                                               analysis for the facility; and                          Hazard Category 1, 2, or 3 DOE nuclear                nuclear facility with fissionable material
                                                 (5) Establish the hazard controls upon                facility discovers or is made aware of a              in a form and amount sufficient to pose
                                               which the contractor will rely to ensure                potential inadequacy of the documented                a potential for criticality, define a
                                               adequate protection of workers, the                     safety analysis, it must:                             criticality safety program that:
                                               public, and the environment.                              (1) Take action, as appropriate, to                    (i) Ensures that operations with
                                                 (c) In maintaining the safety basis for               place or maintain the facility in a safe              fissionable material remain subcritical
                                               a Hazard Category 1, 2, or 3 DOE                        condition until an evaluation of the                  under all normal and credible abnormal
                                               nuclear facility, the contractor                        safety of the situation is completed;                 conditions;
                                               responsible for the facility must:                        (2) Notify DOE of the situation;                       (ii) Identifies applicable nuclear
                                                 (1) Update the safety basis to keep it                  (3) Perform a USQ determination and
                                                                                                                                                             criticality safety standards; and
                                               current and to reflect changes in the                   notify DOE promptly of the results; and
                                                                                                                                                                (iii) Describes how the program meets
                                               facility, the work and the hazards as                     (4) Submit the evaluation of the safety
                                                                                                                                                             applicable nuclear criticality safety
                                               they are analyzed in the documented                     of the situation to DOE prior to
                                                                                                                                                             standards.
                                               safety analysis;                                        removing any operational restrictions
                                                 (2) Annually provide DOE the current                  initiated to meet paragraph (f)(1) of this            § 830.205   Technical safety requirements.
                                               documented safety analysis or a letter                  section.                                                 (a) A contractor responsible for a
                                               stating that there have been no changes                                                                       Hazard Category 1, 2, or 3 DOE nuclear
                                                                                                       § 830.204    Documented safety analysis.
                                               in the documented safety analysis since                                                                       facility must:
                                               the prior submittal; and                                  (a) The contractor responsible for a
                                                                                                       Hazard Category 1, 2, or 3 DOE nuclear                   (1) Develop technical safety
                                                 (3) Incorporate in the safety basis any                                                                     requirements that are derived from the
                                               changes, conditions, or hazard controls                 facility must obtain approval from DOE
                                                                                                       for the methodology used to prepare the               documented safety analysis;
                                               directed by DOE.                                                                                                 (2) Prior to use, obtain DOE approval
                                                                                                       documented safety analysis for the
                                               § 830.203   Unreviewed safety question                  facility unless the contractor uses a                 of technical safety requirements and any
                                               process.                                                methodology set forth in Table 1 of                   change to technical safety requirements;
                                                  (a) The contractor responsible for a                 Appendix A to this Part.                              and
                                               Hazard Category 1, 2, or 3 DOE nuclear                    (b) The documented safety analysis                     (3) Notify DOE of any violation of a
                                               facility must establish, implement, and                 for a Hazard Category 1, 2, or 3 DOE                  technical safety requirement.
                                               take actions consistent with a DOE-                     nuclear facility must, as appropriate for                (b) A contractor may take emergency
                                               approved USQ procedure that meets the                   the complexities and hazards associated               actions that depart from an approved
                                               requirements of this section.                           with the facility:                                    technical safety requirement when no
                                                  (b) The contractor responsible for a                   (1) Describe the facility (including the            actions consistent with the technical
                                               new Hazard Category 1, 2, or 3 DOE                      design of safety structures, systems and              safety requirement are immediately
                                               nuclear facility must submit for DOE                    components) and the work to be                        apparent, and when these actions are
                                               approval a procedure for its USQ                        performed;                                            needed to protect workers, the public or
                                               process on a schedule that allows DOE                     (2) Provide a systematic identification             the environment from imminent and
                                               approval in a safety evaluation report                  of both natural and man-made hazards                  significant harm. Such actions must be
                                               issued pursuant to section 207(a) of this               associated with the facility;                         approved by a certified operator for a
                                               Part.                                                     (3) Evaluate normal, abnormal, and                  reactor or by a person in authority as
                                                  (c) The contractor responsible for a                 accident conditions, including                        designated in the technical safety
                                               Hazard Category 1, 2, or 3 DOE nuclear                  consideration of natural and man-made                 requirements for nonreactor nuclear
                                               facility must implement the DOE-                        external events, identification of energy             facilities. The contractor must report the
                                               approved USQ procedure in situations                    sources or processes that might                       emergency actions to DOE as soon as
                                               where there is a:                                       contribute to the generation or                       practicable.
                                                  (1) Temporary or permanent change                    uncontrolled release of radioactive and                  (c) A contractor for an environmental
                                               in the facility as described in the                     other hazardous materials, and                        restoration activity may follow the
                                               existing documented safety analysis;                    consideration of the need for analysis of             provisions of 29 CFR 1910.120 or
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                                                  (2) Temporary or permanent change                    accidents which may be beyond the                     1926.65 to develop the appropriate
                                               in the procedures as described in the                   design basis of the facility;                         hazard controls (rather than the
                                               existing documented safety analysis;                      (4) Derive the hazard controls                      provisions for technical safety
                                                  (3) Test or experiment not described                 necessary to ensure adequate protection               requirements in paragraph (a) of this
                                               in the existing documented safety                       of workers, the public, and the                       section), provided the activity involves
                                               analysis; or                                            environment, demonstrate the adequacy                 either:
                                                  (4) Potential inadequacy of the                      of these controls to eliminate, limit, or                (1) Work not done within a permanent
                                               documented safety analysis because the                  mitigate identified hazards, and define               structure, or


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                                                                    Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Proposed Rules                                               38993

                                                 (2) The decommissioning of a facility                 work be conducted safely and efficiently and          prepared in accordance with integrated safety
                                               with only low-level residual fixed                      in a manner that ensures protection of                management provisions, including existing
                                               radioactivity.                                          workers, the public, and the environment.             DOE safety requirements in contracts, should
                                                                                                                                                             meet the requirements of this Subpart.
                                                                                                       B. Purpose                                              3. DOE does not expect there to be any
                                               § 830.206   Preliminary documented safety
                                               analysis.                                                 1. The safety basis requirements of part 830        conflict between contractual requirements
                                                                                                       require the contractor responsible for a DOE          and regulatory requirements. In fact, DOE
                                                  Prior to construction of a new Hazard                nuclear facility to analyze the facility, the         expects that contract provisions will be used
                                               Category 1, 2, or 3 DOE nuclear facility                work to be performed, and the associated              to provide more detail on implementation of
                                               or a major modification to an existing                  hazards and to identify the conditions, safe          safety basis requirements such as preparing
                                               Hazard Category 1, 2, or 3 DOE nuclear                  boundaries, and hazard controls necessary to          a documented safety analysis, developing
                                               facility, the contractor responsible for                protect workers, the public and the                   technical safety requirements, and
                                               the design and construction of the new                  environment from adverse consequences.                implementing a USQ process.
                                               facility or major modification must:                    These analyses and hazard controls
                                                                                                       constitute the safety basis upon which the            E. Enforcement of Safety Basis Requirements
                                                  (a) Prepare a preliminary documented
                                                                                                       contractor and DOE rely to conclude that the             1. Enforcement of the safety basis
                                               safety analysis for the facility, and                                                                         requirements will be performance oriented.
                                                                                                       facility can be operated safely. Performing
                                                  (b) Obtain DOE approval of:                          work consistent with the safety basis                 That is, DOE will focus its enforcement
                                                  (1) The nuclear safety design criteria               provides reasonable assurance of adequate             efforts on whether a contractor operates a
                                               to be used in preparing the preliminary                 protection of workers, the public, and the            nuclear facility consistent with the safety
                                               documented safety analysis unless the                   environment.                                          basis for the facility and, in particular,
                                               contractor uses the design criteria in                    2. The safety basis requirements are                whether work is performed in accordance
                                               DOE Order 420.1, Facility Safety, or                    intended to further the objective of making           with the safety basis.
                                               successor document; and                                 safety an integral part of how work is                   2. As part of the approval process, DOE
                                                  (2) The preliminary documented                       performed throughout the DOE complex.                 will review the content and quality of the
                                                                                                       Developing a thorough understanding of a              safety basis documentation. DOE intends to
                                               safety analysis before the contractor can
                                                                                                       nuclear facility, the work to be performed,           use the approval process to assess the
                                               procure materials or components or                                                                            adequacy of a safety basis developed by a
                                                                                                       the associated hazards and the needed hazard
                                               begin construction; provided that DOE                   controls is essential to integrating safety into      contractor to ensure that workers, the public,
                                               may authorize the contractor to perform                 management and work at all levels.                    and the environment are provided reasonable
                                               limited procurement and construction                    Performing work in accordance with the                assurance of adequate protection from
                                               activities without approval of a                        safety basis for a nuclear facility is the            identified hazards. Once approved by DOE,
                                               preliminary documented safety analysis                  realization of that objective.                        the safety basis documentation will not be
                                               if DOE determines that the activities are                                                                     subject to regulatory enforcement actions
                                                                                                       C. Scope                                              unless DOE determines that the information
                                               not detrimental to public health and
                                                                                                          1. A contractor must establish and                 which supports the documentation is not
                                               safety and are in the best interests of                 maintain a safety basis for a Hazard Category         complete and accurate in all material
                                               DOE.                                                    1, 2, or 3 DOE nuclear facility because these         respects, as required by 10 CFR 820.11. This
                                                                                                       facilities have the potential for significant         is consistent with the DOE enforcement
                                               § 830.207   DOE approval of safety basis.
                                                                                                       radiological consequences. DOE–STD–1027               provisions and policy in 10 CFR part 820.
                                                  (a) With respect to a new Hazard                     sets forth the methodology for categorizing a            3. DOE does not intend the adoption of the
                                               Category 1, 2, or 3 DOE nuclear facility                DOE nuclear facility based on the inventory           safety basis requirements to affect the
                                               or a major modification to an existing                  of radioactive materials.                             existing quality assurance requirements or
                                               Hazard Category 1, 2, or 3 DOE nuclear                     2. Unlike the quality assurance                    the existing obligation of contractors to
                                               facility, a contractor may not begin                    requirements of part 830 that apply to all            comply with the quality assurance
                                               operation of the facility or modification               DOE nuclear facilities the safety basis               requirements. In particular, in conjunction
                                                                                                       requirements only apply to Hazard Category            with the adoption of the safety basis
                                               prior to the issuance of a safety
                                                                                                       1, 2, and 3 DOE nuclear facilities and do not         requirements, DOE revised the language in 10
                                               evaluation report in which DOE                          apply to nuclear facilities below Hazard              CFR 830.122(e)(1) to make clear that hazard
                                               approves the safety basis for the facility              Category 3.                                           controls are part of the work processes to
                                               or modification.                                                                                              which a contractor and other persons must
                                                  (b) Pending issuance of a safety                     D. Integrated Safety Management                       adhere when performing work. This
                                               evaluation report in which DOE                            1. The safety basis requirements are                obligation to perform work consistent with
                                               approves an updated or amended safety                   consistent with integrated safety                     hazard controls adopted to meet regulatory or
                                               basis for an existing Hazard Category 1,                management. DOE expects that, if a                    contract requirements existed prior to the
                                                                                                       contractor complies with the Department of            adoption of the safety basis requirements and
                                               2, or 3 DOE nuclear facility, the
                                                                                                       Energy Acquisition Regulation (DEAR) clause           is both consistent with and independent of
                                               contractor responsible for the facility                 on integration of environment, safety, and            the safety basis requirements.
                                               must continue to perform work in                        health into work planning and execution (48              4. A documented safety analysis must
                                               accordance with the DOE-approved                        CFR 970.5223–1, Integration of Environment,           address all hazards (that is, both radiological
                                               safety basis for the facility and maintain              Safety and Health into Work Planning and              and nonradiological hazards) and the
                                               the existing safety basis consistent with               Execution) and the DEAR clause on laws,               controls necessary to provide adequate
                                               the requirements of this Subpart.                       regulations, and DOE directives (48 CFR               protection to the public, workers, and the
                                                                                                       970.5204–2, Laws, Regulations and DOE                 environment from these hazards. Section
                                               Appendix A to Subpart B to Part 830—                    Directives), the contractor will have                 234A of the Atomic Energy Act only
                                               General Statement of Safety Basis                       established the foundation to meet the safety         authorizes DOE to issue civil penalties for
                                               Policy                                                  basis requirements.                                   violations of requirements related to nuclear
                                                                                                         2. The processes embedded in a safety               safety. Therefore, DOE will impose civil
                                               A. Introduction
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                                                                                                       management system should lead to a                    penalties for violations of the safety basis
                                                 This appendix describes DOE’s                         contractor establishing adequate safety bases         requirements (including hazard controls)
                                               expectations for the safety basis requirements          and safety management programs that will              only if they are related to nuclear safety.
                                               of 10 CFR part 830, acceptable methods for              meet the safety basis requirements of this
                                               implementing these requirements, and                    Subpart. Consequently, the DOE expects if a           F. Documented Safety Analysis
                                               criteria DOE will use to evaluate compliance            contractor has adequately implemented                   1. A documented safety analysis must
                                               with these requirements. This Appendix does             integrated safety management, few additional          demonstrate the extent to which a nuclear
                                               not create any new requirements and should              requirements will stem from this Subpart              facility can be operated safely with respect to
                                               be used consistently with DOE’s policy that             and, in such cases, the existing safety basis         workers, the public, and the environment.



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                                               38994                     Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Proposed Rules

                                                 2. DOE expects a contractor to use a graded                       submitted as part of a positive USQ or major        contain any conditions or changes required
                                               approach to develop a documented safety                             modification; (3) if DOE has reason to believe      by DOE in the Safety Evaluation Report.
                                               analysis and describe how the graded                                a portion of the safety basis to be inadequate,     Generally, DOE’s review of the annual
                                               approach was applied. The level of detail,                          or; (4) if DOE has reason to believe a portion      submittal may be limited to ensuring that the
                                               analysis, and documentation will reflect the                        of the safety basis has substantially changed.      results of USQs have been adequately
                                               complexity and hazards associated with a                            DOE will review the DSA to determine                incorporated into the DSA. If additional
                                               particular facility. Thus, the documented                           whether the rigor and detail of the                 changes are proposed by the contractor and
                                               safety analysis for a simple, low hazard                            documented safety analysis are appropriate          included in the annual update that have not
                                               facility may be relatively short and                                for the complexity and hazards expected at
                                                                                                                                                                       been previously approved by DOE or have
                                               qualitative in nature, while the documented                         the nuclear facility. In particular, DOE will
                                               safety analysis for a complex, high hazard                          evaluate the documented safety analysis by          not been evaluated as a part of the USQ
                                               facility may be quite elaborate and more                            considering the extent to which the                 process, DOE must review and approve these
                                               quantitative. DOE will work with its                                documented safety analysis (1) satisfies the        changes. DOE has the authority to review the
                                               contractors to ensure a documented safety                           provisions of the methodology used to               safety basis at any time.
                                               analysis is appropriate for the facility for                        prepare the documented safety analysis and            4. In most cases, the contract will provide
                                               which it is being developed.                                        (2) adequately addresses the criteria set forth     the framework for specifying the
                                                 3. Because DOE has ultimate responsibility                        in 10 CFR 830.204(b). DOE will prepare a            methodology and schedule for developing a
                                               for the safety of its facilities, DOE will review                   Safety Evaluation Report to document the            documented safety analysis. Table 1 sets
                                               each documented safety analysis as: (1) Part                        results of its review of the documented safety      forth acceptable methodologies for preparing
                                               of the initial submittal; (2) when revisions are                    analysis. A documented safety analysis must         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 doc-
                                                                                                                      ument.
                                               (2) A DOE nonreactor nuclear facility ................               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.
                                               (3) A DOE nuclear facility with a limited oper-                      Using the method in either:
                                                 ational life.                                                      (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.
                                               (4) The deactivation or the transition surveil-                      Using the method in either:
                                                 lance and maintenance of a DOE nuclear fa-                         (1) DOE–STD–3009, Change Notice No. 1, January 2000, or successor document, or
                                                 cility.                                                            (2) DOE–STD–3011–94 or successor document.
                                               (5) The decommissioning of a DOE nuclear fa-                         (1) Using the method in DOE–STD–1120–98, Integration of Environment, Safety, and Health
                                                 cility.                                                              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 restoration activity                         (1) Using the method in DOE–STD–1120–98 or successor document, and
                                                 that involves either work not done within a                        (2) Using the provisions in 29 CFR 1910.120 (or 29 CFR 1926.65 for construction activities)
                                                 permanent structure or the decommissioning                           for developing a Safety and Health Program and a site-specific Health and Safety Plan (in-
                                                 of a facility with only low-level residual fixed                     cluding elements for Emergency Response Plans, conduct of operations, training and quali-
                                                 radioactivity.                                                       fications, and maintenance management).
                                               (7) A DOE nuclear explosive facility and the nu-                     Developing its documented safety analysis in two pieces:
                                                 clear explosive operations conducted therein..                     (1) A Safety Analysis Report for the nuclear facility that considers the generic nuclear explo-
                                                                                                                      sive 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 accord-
                                                                                                                      ance with DOE–STD–3016–99, Hazards Analysis Reports for Nuclear Explosive Operations,
                                                                                                                      February 1999, or successor document.
                                               (8) A DOE Hazard Category 3 nonreactor nu-                           Using the methods in Chapters 2, 3, 4, and 5 of DOE–STD–3009, Change Notice No. 1, Janu-
                                                 clear facility.                                                      ary 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 pro-
                                                                                                                      grams) 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, Imple-
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                                                                                                                      mentation Guide for Use with DOE O 460.1A, Packaging and Transportation Safety, June 5,
                                                                                                                      1997, or successor document.
                                               (10) Transportation and onsite transfer of nu-                       (1) Preparing a Safety Analysis Report for Packaging in accordance with DOE–O–461.1,
                                                 clear explosives, nuclear components, Navel                          Packaging and Transportation of Materials of National Security Interest, September 29,
                                                 nuclear fuel elements, Category I and Cat-                           2000, or successor document and
                                                 egory II special nuclear materials, special as-                    (2) Preparing a Transportation Safety Document in accordance with DOE–M–461.1–1, Pack-
                                                 semblies, and other materials of national se-                        aging and Transfer of Materials of National Security Interest Manual, September 29, 2000,
                                                 curity.                                                              or successor document.



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                                                                          Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Proposed Rules                                                       38995

                                                 5. Table 1 refers to specific types of nuclear                       a nonreactor nuclear facilities where an             requirements established by this Part. The
                                               facilities. These references are not intended                          activity is conducted for or on behalf of DOE        only exceptions are those facilities
                                               to constitute an exhaustive list of the specific                       and includes any related area, structure,            specifically excluded such as accelerators.
                                               types of nuclear facilities. Part 830 defines                          facility, or activity to the extent necessary to     Table 2 defines the terms referenced in Table
                                               nuclear facility broadly to include reactor or                         ensure proper implementation of the                  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 haz-
                                                                                                                         ardous 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 activities ..............                 The process by which contaminated sites and facilities are identified and characterized and by
                                                                                                                         which existing contamination is contained, or removed and disposed.
                                               (5) Generic nuclear explosive operation ............                    A characterization that considers the collective attributes (such as special facility system re-
                                                                                                                         quirements, physical weapon characteristics, or quantities and chemical/physical forms of
                                                                                                                         hazardous materials) for all projected nuclear explosive operations to be conducted at a fa-
                                                                                                                         cility.
                                               (6) Nuclear explosive facility ...............................          A nuclear facility at which nuclear operations and activities involving a nuclear explosive may
                                                                                                                         be conducted.
                                               (7) Nuclear explosive operation ..........................              Any activity involving a nuclear explosive, including activities in which main-charge, high-explo-
                                                                                                                         sive parts and pits are collocated.
                                               (8) Nuclear facility with a limited operational life                    A nuclear facility for which there is a short remaining operational period before ending the fa-
                                                                                                                         cility’s mission and initiating deactivation and decommissioning and for which there are no
                                                                                                                         intended additional missions other than cleanup.
                                               (9) Specific nuclear explosive operation ............                   A specific nuclear explosive subjected to the stipulated steps of an individual operation, such
                                                                                                                         as assembly or disassembly.
                                               (10) Transition surveillance and maintenance                            Activities conducted when a facility is not operating or during deactivation, decontamination,
                                                 activities.                                                             and decommissioning operations when surveillance and maintenance are the predominant
                                                                                                                         activities being conducted at the facility. These activities are necessary for satisfactory con-
                                                                                                                         tainment 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                        G. Hazard Controls                                   function, then describing the structure,
                                               and construction of a new Hazard Category                                 1. Hazard controls are measures to                systems, and components, placing functional
                                               1, 2, or 3 DOE nuclear facility or a major                             eliminate, limit, or mitigate hazards to             requirements on those portions of the
                                               modification to an existing Hazard Category                            workers, the public, or the environment.             structures, systems, and components
                                               1, 2, or 3 DOE nuclear facility must prepare                           They include: (1) Physical, design, structural,      required for the safety function, and
                                               a preliminary documented safety analysis. A                            and engineering features; (2) safety                 identifying performance criteria that will
                                               preliminary documented safety analysis can                             structures, systems, and components; (3)             ensure functional requirements are met.
                                               ensure that substantial costs and time are not                         safety management programs; (4) technical            Technical safety requirements are developed
                                               wasted in constructing a nuclear facility that                         safety requirements; and (5) other controls          to ensure the operability of the safety
                                               will not be acceptable to DOE. If a contractor                         necessary to provide adequate protection             structures, systems, and components and
                                               is required to prepare a preliminary                                   from hazards.                                        define actions to be taken if a safety
                                               documented safety analysis, the contractor                                2. The types and specific characteristics of      structure, system, or component is not
                                               must obtain DOE approval of the preliminary                            the safety management programs necessary             operable.
                                               documented safety analysis prior to                                    for a DOE nuclear facility will be dependent            4. Technical safety requirements establish
                                               procuring materials or components or                                   on the complexity and hazards associated             limits, controls, and related actions necessary
                                               beginning construction. DOE, however, may                              with the nuclear facility and the work being         for the safe operation of a nuclear facility.
                                               authorize the contractor to perform limited                            performed. In most cases, however, a                 The exact form and contents of technical
                                               procurement and construction activities                                contractor should consider safety
                                                                                                                                                                           safety requirements will depend on the
                                               without approval of a preliminary                                      management programs covering topics such
                                                                                                                                                                           circumstances of a particular nuclear facility
                                               documented safety analysis if DOE                                      as quality assurance, procedures,
                                                                                                                                                                           as defined in the documented safety analysis
                                               determines that the activities are not                                 maintenance, personnel training, conduct of
                                               detrimental to public health and safety and                            operations, criticality safety, emergency            for the nuclear facility. As appropriate,
                                               are in the best interests of DOE. DOE Order                            preparedness, fire protection, waste                 technical safety requirements may have
                                               420.1, or successor document, sets forth                               management, and radiation protection. In             sections on: (1) Safety limits; (2) operating
                                               acceptable nuclear safety design criteria for                          general, DOE Orders set forth DOE’s                  limits; (3) surveillance requirements; (4)
                                               use in preparing a preliminary documented                              expectations concerning specific topics. For         administrative controls; (5) use and
                                                                                                                                                                           application; and (6) design features. It may
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                                               safety analysis. As a general matter, DOE                              example, DOE Order 420.1, or successor
                                               does not expect preliminary documented                                 document provides DOE’s expectations with            also have an appendix on the bases for the
                                               safety analyses to be needed for activities that                       respect to fire protection and criticality           limits and requirements. DOE Guide 423.1–
                                               do not involve significant construction such                           safety.                                              1B, Implementation Guide for Use in
                                               as environmental restoration activities,                                  3. Safety structures, systems, and                Developing Technical Safety Requirements,
                                               decontamination and decommissioning                                    components require formal definition of              or successor document, provides a complete
                                               activities, specific nuclear explosive                                 minimum acceptable performance in the                description of what technical safety
                                               operations, or transition surveillance and                             documented safety analysis. This is                  requirements should contain and how they
                                               maintenance activities.                                                accomplished by first defining a safety              should be developed and maintained.



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                                               38996                       Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Proposed Rules

                                                  5. DOE will examine and approve the                                  changes in the facility, the work and the           controls as appropriate, as controlled
                                               technical safety requirements as part of                                hazards as they are analyzed in the                 documents with an authorized users list.
                                               preparing the safety evaluation report and                              documented safety analysis. In addition, DOE          6. Table 3 sets forth DOE’s expectations
                                               reviewing updates to the safety basis. As with                          expects a contractor to maintain technical          concerning acceptable technical safety
                                               all hazard controls, technical safety                                   safety requirements, and other hazard               requirements.
                                               requirements must be kept current and reflect

                                                                                                                                          TABLE 3
                                               As appropriate for a particular DOE nuclear
                                               facility, the section of the technical safety                            Will provide information on:
                                               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 re-
                                                                                                                          quirement should state that the contractor must obtain DOE authorization to restart the nu-
                                                                                                                          clear 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 oper-
                                                                                                                          ating limits section may include subsections on limiting control settings and limiting condi-
                                                                                                                          tions 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 vari-
                                                                                                                          ables 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 lim-
                                                                                                                          ited 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 operations .................                 The limits that represent the lowest functional capability or performance level of safety struc-
                                                                                                                          tures, systems, and components required to perform an activity safely. The limiting condi-
                                                                                                                          tions for operation section describes, as precisely as possible, the lowest functional capa-
                                                                                                                          bility 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 pro-
                                                                                                                          vides 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 oper-
                                                                                                                          ation is within safety limits; and that limiting control settings and limiting conditions for oper-
                                                                                                                          ation are met. If a required surveillance is not successfully completed, the contractor is ex-
                                                                                                                          pected 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 fre-
                                                                                                                          quency, 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 nec-
                                                                                                                          essary 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 provisions .....................                 The basic instructions for applying the safety restrictions contained in a technical safety re-
                                                                                                                          quirement. 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.
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                                               (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 require-
                                                                                                                          ment is to ensure that any future changes to the limit or requirement is done with full knowl-
                                                                                                                          edge 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                                                   38997

                                               H. Unreviewed Safety Questions                          ACTION:   Proposed rule.                              weekdays between 9 a.m. and 3 p.m. To
                                                  1. The USQ process is an important tool to                                                                 make an appointment, call (703) 518–
                                               evaluate whether changes affect the safety              SUMMARY:    The NCUA Board (Board) is                 6546, or send an email to OGCMail@
                                               basis. A contractor must use the USQ process            seeking comment on a proposed rule                    ncua.gov.
                                               to ensure that the safety basis for a DOE               that would amend the NCUA’s
                                               nuclear facility is not undermined by                   previously revised regulations regarding              FOR FURTHER INFORMATION CONTACT:
                                               changes in the facility, the work performed,            prompt corrective action (PCA). The                   Policy and Analysis: Julie Cayse,
                                               the associated hazards, or other factors that           proposal would delay the effective date               Director, Division of Risk Management,
                                               support the adequacy of the safety basis.               of the NCUA’s October 29, 2015 final                  Office of Examination and Insurance, at
                                                  2. The USQ process permits a contractor to                                                                 (703) 518–6360; Kathryn Metzker, Loss/
                                               make physical and procedural changes to a
                                                                                                       rule regarding risk-based capital (2015
                                                                                                       Final Rule) for one year, moving the                  Risk Analyst, Division of Risk
                                               nuclear facility and to conduct tests and
                                               experiments without prior approval,                     effective date from January 1, 2019 to                Management, Office of Examination and
                                               provided these changes do not cause a USQ.              January 1, 2020. During the extended                  Insurance, at (703) 548–2456; Julie
                                               The USQ process provides a contractor with              delay period, the NCUA’s current PCA                  Decker, Loss/Risk Analyst, Division of
                                               the flexibility needed to conduct day-to-day            requirements would remain in effect.                  Risk Management, Office of
                                               operations by requiring only those changes              The proposal would also amend the                     Examination and Insurance, at (703)
                                               and tests with a potential to impact the safety         definition of a ‘‘complex’’ credit union              518–3684; Aaron Langley, Risk
                                               basis (and therefore the safety of the nuclear                                                                Management Officer, Division of
                                               facility) be approved by DOE. This allows
                                                                                                       adopted in the 2015 Final Rule for risk-
                                                                                                       based capital purposes by increasing the              Analytics and Surveillance, Office of
                                               DOE to focus its review on those changes
                                               significant to safety. The USQ process helps            threshold level for coverage from $100                Examination and Insurance, at (703)
                                               keep the safety basis current by ensuring               million to $500 million. These proposed               518–6387; Legal: John Brolin, Staff
                                               appropriate review of and response to                   changes would provide covered credit                  Attorney, Office of General Counsel, at
                                               situations that might adversely affect the              unions and the NCUA with additional                   (703) 518–6540; or by mail at National
                                               safety basis.                                           time to prepare for the rule’s                        Credit Union Administration, 1775
                                                  3. DOE Guide 424.1–1B Chg 2,                                                                               Duke Street, Alexandria, VA 22314.
                                               Implementation Guide for Use in Addressing
                                                                                                       implementation, and would exempt an
                                               Unreviewed Safety Question Requirements,                additional 1,026 credit unions from the               SUPPLEMENTARY INFORMATION:
                                               or successor document provides DOE’s                    rule without subjecting the National
                                                                                                                                                             I. Introduction
                                               expectations for a USQ process. The                     Credit Union Share Insurance Fund
                                               contractor must obtain DOE approval of its              (NCUSIF) to undue risk.                                  The NCUA’s primary mission is to
                                               procedure used to implement the USQ                     DATES: Comments must be received by                   ensure the safety and soundness of
                                               process. The contractor is allowed to make              September 7, 2018.                                    federally insured credit unions. The
                                               editorial and format changes to its USQ                                                                       agency performs this function by
                                               procedure while maintaining DOE approval.               ADDRESSES: You may submit written
                                                                                                       comments, identified by RIN 3133–                     examining and supervising all federal
                                               I. Functions and Responsibilities                       AE90, by any of the following methods                 credit unions, participating in the
                                                  1. The DOE Management Official for a DOE             (Please send comments by one method                   examination and supervision of
                                               nuclear facility (that is, the Assistant                only):                                                federally insured, state-chartered credit
                                               Secretary, the Assistant Administrator, or the             • Federal eRulemaking Portal: http://              unions in coordination with state
                                               Office Director who is primarily responsible
                                                                                                       www.regulations.gov. Follow the                       regulators, and insuring members’
                                               for the management of the facility) has                                                                       accounts at federally insured credit
                                               primary responsibility within DOE for                   instructions for submitting comments.
                                                                                                          • NCUA website: http://                            unions.1 In its role as administrator of
                                               ensuring that the safety basis for the facility                                                               the NCUSIF, the NCUA insures and
                                               is adequate and complies with the safety                www.ncua.gov/Legal/Regs/Pages/
                                               basis requirements of Part 830. The DOE                 PropRegs.aspx. Follow the instructions                regulates approximately 5,573 federally
                                               Management Official is responsible for                  for submitting comments.                              insured credit unions, holding total
                                               ensuring the timely and proper (1) review of               • Email: Address to regcomments@                   assets exceeding $1.4 trillion and
                                               all safety basis documents submitted to DOE             ncua.gov. Include ‘‘[Your name]—                      representing approximately 111 million
                                               and (2) preparation of a safety evaluation              Comments on Proposed Rule: Risk-                      members.2
                                               report concerning the safety basis for a                Based Capital—Supplemental Proposal’’                    At its October 2015 meeting, the
                                               facility.                                                                                                     Board issued the 2015 Final Rule to
                                                  2. DOE will maintain a public list on the
                                                                                                       in the email subject line.
                                               internet that provides the status of the safety            • Fax: (703) 518–6319. Use the                     amend Part 702 of the NCUA’s PCA
                                                                                                       subject line described above for email.               regulations to require that credit unions
                                               basis for each Hazard Category 1, 2, or 3 DOE
                                               nuclear facility and, to the extent practicable,           • Mail: Address to Gerard Poliquin,                taking certain risks hold capital
                                               provides information on how to obtain a                 Secretary of the Board, National Credit               commensurate with those risks.3 The
                                               copy of the safety basis and related                    Union Administration, 1775 Duke                       risk-based capital provisions of the 2015
                                               documents for a facility.                               Street, Alexandria, Virginia 22314–                   Final Rule apply only to federally
                                               [FR Doc. 2018–16863 Filed 8–7–18; 8:45 am]              3428.                                                 insured, natural-person credit unions
                                               BILLING CODE 6450–01–P
                                                                                                          • Hand Delivery/Courier: Same as                   with quarter-end total assets exceeding
                                                                                                       mail address.                                         $100 million. The overarching intent of
                                                                                                          You can view all public comments on                the 2015 Final Rule is to reduce the
                                                                                                       the NCUA’s website at http://                         likelihood that a relatively small
                                               NATIONAL CREDIT UNION
                                                                                                       www.ncua.gov/Legal/Regs/Pages/                        number of high-risk outlier credit
                                               ADMINISTRATION
                                                                                                       PropRegs.aspx as submitted, except for                unions would exhaust their capital and
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                                               12 CFR Part 702                                         those we cannot post for technical                    cause large losses to the NCUSIF. Under
                                                                                                       reasons. The NCUA will not edit or
                                               RIN 3133–AE90                                           remove any identifying or contact                       1 As of December 31, 2017, within the nine states

                                                                                                       information from the public comments                  that allow privately insured credit unions,
                                               Risk-Based Capital—Supplemental                                                                               approximately 116 state-chartered credit unions are
                                                                                                       submitted. You may inspect paper
                                               Rule                                                                                                          privately insured and are not subject to the NCUA’s
                                                                                                       copies of comments in the NCUA’s law                  regulation and oversight.
                                               AGENCY:National Credit Union                            library at 1775 Duke Street, Alexandria,                2 Based on December 31, 2017 Call Report Data.

                                               Administration (NCUA).                                  Virginia 22314, by appointment                          3 80 FR 66625 (Oct. 29, 2015).




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Document Created: 2018-08-08 02:04:29
Document Modified: 2018-08-08 02:04:29
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionNotice of proposed rulemaking and notice of public meetings.
DatesPublic 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.
ContactMr. 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]
FR Citation83 FR 38982 
RIN Number1992-AA57
CFR AssociatedAdministrative 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

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