[Federal Register Volume 83, Number 153 (Wednesday, August 8, 2018)]
[Proposed Rules]
[Pages 38982-38997]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16863]


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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: <a href="/cdn-cgi/l/email-protection#b7e5c2dbd2dad6dcded9d0998f8487f7dfc699d3d8d299d0d8c1"><span class="__cf_email__" data-cfemail="1745627b727a767c7e7970392f2427577f663973787239707861">[email protected]</span></a>. 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 <a href="/cdn-cgi/l/email-protection#056b70666960647776646360717c456d742b616a602b626a73"><span class="__cf_email__" data-cfemail="711f04121d1410030210171405083119005f151e145f161e07">[email protected]</span></a>.

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


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