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1810 Federal Register / Vol. 66, No. 7/ Wednesday, January 10, 2001/ Rules and Regulations

issued August 5, 1998, are adopted as afinal rule with the following change:

PART 1446PEANUTS

1. The authority citation for part 7CFR part 1446 continues to read asfollows:

Authority: 7 U.S.C. 7271; 15 U.S.C. 714b

and 714c.

2. Paragraph (c) of 1446.102 isamended by adding a new sentence tothe end of the paragraph to read asfollows:

1446.102 Administration.

* * * * *

(c) Supervisory authority. * * *Further, the Director of TPD, FSA, mayauthorize the wavier or modification ofdeadlines and other requirements,except statutory deadlines orrequirements, in cases where lateness orthe failure to meet such otherrequirements does not adversely affectoperation of the program.

3. Paragraph (3) of the definition ofSegregations in 1446.103 is revisedto read as follows:

1446.103 Definitions.

* * * * *

(3) Segregation 3. Segregation 3peanuts are farmers stock peanutswhich, upon visible inspection, arefound to contain Aspergillus flavusmold: Provided further, however, That,in accordance with such writteninstructions as the Director may issue,

the Director shall permit producers atapproved buying points as specified bythe Director to have the Segregation 3lot reconditioned, one time only, andthen reinspected visually. If the buyingpoint where the peanuts were initiallydelivered does not have adequatecleaning facilities, CCC may approve analternative buying point for cleaningand reinspection. The visualreinspection may not occur more than72 hours from the initial inspectionexcept as permitted by the Director andthe second grade shall be considered thefinal grade for the farmers stock

peanuts. 1444.307 [Amended]

4. Section 1444.307 is amended byremoving paragraph (g) from thatsection.

Signed at Washington, D.C., on January 3,2001.

Keith Kelly,

Executive Vice President, Commodity CreditCorporation.

[FR Doc. 01651 Filed 1901; 8:45 am]

BILLING CODE 341005P

DEPARTMENT OF ENERGY

10 CFR Part 830

RIN 1901AA34

Nuclear Safety Management

AGENCY: Department of EnergyACTION: Final rule.

SUMMARY: The Department of Energy(DOE) adopts, with minor changes, theinterim final rule published on October10, 2000, to amend the DOE NuclearSafety Management regulations.EFFECTIVE DATE: This final rule iseffective on February 9, 2001.FOR FURTHER INFORMATION CONTACT:Richard Black, Director, Office ofNuclear and Facility Safety Policy,270CC, Department of Energy, 19901Germantown Road, Germantown, MD20874; telephone: 3019033465; e-mail: [email protected] INFORMATION

:I. Introduction and Summary

On October 10, 2000, the Departmentof Energy (DOE) published an interimfinal rule in the Federal Register (65 FR60291) that amended DOEs nuclearsafety regulations in 10 CFR Part 830(Interim Final Rule). DOE provided a30-day public comment period for theInterim Final Rule and subsequentlyreceived comments to the rule from over30 parties. As a result of the commentsthat were received to that Interim FinalRule, DOE became aware of a number ofminor errors in the published version of

the rule and the preamble, as well as anumber of minor changes to the rulethat would clarify and simplifyimplementation of the amended rule.We are republishing the rule as a finalrule with those changes. Finally, we aresummarizing the issues raised in thecomments to the Interim Final Rule andproviding DOEs responses to the majorissues. Many of the commentsconcerned rule implementation issuesthat will be addressed in the ruleimplementation guides.

II. Discussion of Changes to the Rule

The following changes to 10 CFR Part830 are being made in response tocomments to the Interim Final Rule.

A. Changes to 830.2, Exclusions

We are amending paragraph 830.2(d)to exclude the mixed oxide fuelfabrication and irradiation facilities thatthe Nuclear Regulatory Commission(NRC) has the authority to license andregulate under 3134 of the StromThurmond National DefenseAuthorization Act for Fiscal Year 1999(Public Law 105261). Section 3134

amends the Energy Reorganization Actof 1974 to add 202(5) (42 U.S.C. 5842).This exclusion will make clear thatthese facilities will be licensed by theNRC and must be designed andconstructed to meet NRC regulations.Thus, these facilities are excluded fromthe requirement to meet 10 CFR Part 830

before and after a license is issued by

the NRC.

B. Changes to 830.3, Definitions.

We are revising the followingdefinitions in 830.3:

1. Safety Class Structures, Systems, andComponents

We are revising the words identifiedby the documented safety analysis todetermined from safety analyses tomake the definition consistent withthose for safety structures, systems,and components and safetysignificant structures, systems, andcomponents.

2. Technical Safety Requirements(TSRs)

We are revising the definition of TSRsto express it more clearly. As revised,the definition of TSRs means the limits,controls, and related actions thatestablish the specific parameters andrequisite actions for the safe operationof a nuclear facility and include, asappropriate for the work and thehazards identified in the documentedsafety analysis for the facility: Safetylimits, operating limits, surveillancerequirements, administrative and

management controls, use andapplication provisions, and designfeatures, as well as a bases appendix.The documented safety analysisidentifies the need for TSRs, but theactual limits are identified in the TSRs.The revisions make clear that the TSRsaddress the specific numerical limitsand related actions necessary for safeoperation of a nuclear facility. Becausethe TSRs identify the limits and actionsnecessary in specific situations, it is notappropriate to use the graded approachto justify the use of different limits andactions than those set forth in the TSRs.

The change made to the gradedapproach section is consistent with thischange.

C. Changes to 830.7, Graded Approach

We received a number of commentsrequesting us to clarify where acontractor must use a graded approachand how the graded approachdocumentation should be submitted. Weare revising the language in 830.7 toclarify that a contractor may not use agraded approach in implementing theunreviewed safety question (USQ)

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1811Federal Register / Vol. 66, No. 7/ Wednesday, January 10, 2001/ Rules and Regulations

process or in implementing thetechnical safety requirements. We areaddressing the documentation questionin Section III. I of this preamble.

D. Changes to Subpart B, Safety Basis

1. Section 830.203 Unreviewed SafetyQuestion Process

a. Unreviewed safety question (USQ)procedure. In 830.203 of the InterimFinal Rule we stated that the contractormust submit a USQ process. In fact,the document that specifies how theUSQ process is to be performed is theUSQ procedure. We are changing therule language in 830.203 to reflect thata contractor is to submit a procedurefor its USQ process, rather than aUSQ process. Conforming changes are

being made in Appendix A to SubpartB as well. These changes should beconsidered when reading the USQdiscussions in the preamble to theInterim Final Rule.

b. Existing USQ procedure. In 830.203, we deleted the words DOE-approved from the requirement forcontractors to continue to use theirexisting USQ procedure pendingapproval of the USQ procedure to besubmitted under the rule by April 10.This will ensure that contractors whohave not received DOE-approval fortheir current USQ procedures willcontinue to use their existing USQprocedures.

c. Editorial changes. We made someeditorial changes to 830.203 to make iteasier to read.

2. Section 830.206 PreliminaryDocumented Safety Analysis

We received a number of commentson the application of the requirementsfor a preliminary documented safetyanalysis to new nuclear facilities andmajor modifications to nuclear facilitiesthat were nearly ready to operate. Weagree that the purpose of therequirement is to ensure that DOE andthe contractor agree on designconsiderations during the design andearly construction phases of themodification, and that the final

documented safety analysis willdocument those considerations duringthe final construction efforts.Consequently, we are revising 830.206to apply to hazard category 1, 2, and 3new nuclear facilities and majormodifications for which construction

begins after December 11, 2000.

3. Section 830.207 DOE Approval ofSafety Basis

We are adding the words, or asapproved by DOE on a later date, toparagraph 830.207(b) to clarify that the

contractor must perform work to theapproved safety basis in effect onOctober 10, 2000 unless there is a morerecent DOE-approved safety basis. Theapplicable safety basis for the nuclearfacility is the latest DOE-approvedsafety basis.

E. Appendix A to Subpart B to Part

830General Statement of Safety BasisPolicy

1. We are adding two safe harborprovisions for transportation activitiesin Table 2. This change is discussed inmore detail in the response tocomments.

2. We are making conforming changesin the appendix to be consistent withthe change to the definition of TSRs.

3. Editorial Changes.a. We are adding a reference to Table

1 in paragraph C in Appendix A toSubpart B, Scope.

b. We are revising language inparagraph C in Appendix A to SubpartB to read, all DOE nuclear facilities,including radiological facilities,* * *to clarify that radiological facilities areconsidered to be a subset of nuclearfacilities.

c. We are adding a 3 to the last itemof Table 1 in Appendix A to Subpart Bwhere it was inadvertently omitted.

d. We are editing Table 2 in AppendixA to Subpart B to correct the alignmentand to correct language in paragraph(6)(2) of the table.

e. We are changing the reference to

DOESTD300994 to read DOESTD3009, Change Notice 1, January2000, throughout the rule.

III. Response to Comments on theInterim Final Rule

DOE received written comments fromover 30 interested organizations(primarily DOE contractors) andindividuals on the amendments in theInterim Final Rule for the DOE NuclearSafety Management requirements of 10CFR Part 830. You may examine writtencomments between 9 AM and 4 PM atthe U.S. Department of Energy Freedomof Information Reading Room, Room1E190, 1000 Independence Avenue,SW, Washington, DC 20585, (202) 5863142.

This section of the SupplementaryInformation summarizes the issuesraised in the comments and gives DOEsresponse. Many of the comments raisedquestions and positions related to theimplementation of the requirements.These comments will be considered inthe development of the implementationguides that were discussed in thepreamble to the Interim Final Rule.

Preamble

A. Comment:In the Summary ofChanges in the preamble to the InterimFinal Rule, paragraph G, severalcommentors noted that the paragraphthat reads The USQ process has twosteps * * * is incorrect and should beentirely deleted.

Response:We agree.B. Comment:Several commentorsprovided editorial corrections.

Response:We agree with thefollowing editorial corrections to thepreamble:

1. In the Summary of Changes inthe preamble to the Interim Final Rule,paragraph II.D.f, Existing DOE nuclearfacility and new DOE nuclear facility,the date for new nuclear facilities waserroneously listed as April 9, 2000. Thecorrect date is April 9, 2001.

2. In the Summary of Changes inthe preamble to the Interim Final Rule,paragraph II.D.2.d.vi, on page 60297,

electronic microscopes should beelectron microscopes.

830.1, Scope

C. Comment:A number ofcommentors objected to expanding thescope of the rule to cover activitiesperformed offsite. One commentorsuggested limiting the offsiteapplicability by setting a dollarthreshold for procurement actions,exempting procurement of commercialitems, limiting the applicability tocomponents having nuclear safetysignificance, or reducing fines for offsite

work.Response:We have considered thesuggestions for limiting the applicabilityof the rule offsite and do not agree thatsuch limitations should be adopted. In1995, we gave notice that we wereconsidering an option that wouldexpand the scope of Part 830 to coverconduct that could affect the safemanagement of nuclear facilitieswithout any limitation that suchconduct must occur at nuclear facilities.See the Notice of Limited Reopening ofthe Comment Period, 60 FR 45381,45384 (Aug. 31, 1995). In adopting this

option to cover offsite activities, wenoted that the scope of the rule wouldapply not only to prime contractorsresponsible for a nuclear facility, butalso to subcontractors, suppliers, andother contractors, including those whoprovide items (such as pumps, valves,waste containers, piping, and electricalor mechanical devices) or services (suchas design, engineering, maintenance,and welding) that affect, or may affect,nuclear safety of DOE nuclear facilities.Thus, the provision of items andservices taking place offsite which affect


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nuclear safety would be covered by therule. DOE expects that contractors willestablish specifications and standards intheir procurement documents and flowthem down to all tiers of subcontractorsand suppliers, regardless of whetheritems will be provided or services will

be performed onsite or offsite.We also recognize that in some cases

contractors may not flow downspecifications but may choose toprocure commercial grade items andmaterials and to perform the tests orother actions that are necessary toupgrade these materials or items toallow them to be used as itemsimportant to nuclear safety. Contractorsmay choose to perform the requiredactions to upgrade these materials oritems either for economic reasons or

because qualified vendors cannot befound. In these cases, the supplier isresponsible for meeting therequirements for commercial grade

materials or items as specified in theprocurement documents and thecontractor is responsible for ensuringthe requirements are met for using thesematerials or items as items important tonuclear safety.

We believe that the alternativessuggested for limiting the offsiteapplication of the rule are not necessaryor advisable. Commercial products aswell as small dollar purchases mayaffect nuclear safety of DOE nuclearfacilities depending on their intendeduse. All the facts and circumstancesinvolved in the failure of an item

procured from an offsite vendor orsupplier will be looked at in anysubsequent enforcement action. Civilpenalties can be appropriately mitigatedor adjusted in accordance with theenforcement discretion in 10 CFR Part820.

D. Comment:A number ofcommentors questioned how theyshould apply the requirements of thisrule to transportation activities notregulated by the Department ofTransportation (DOT).

Response:We are amending the ruleto add two additional safe harbor

methods in Table 2 of Appendix A toSubpart B for transportation activitiescovered by this rule. The new safeharbor methods will endorse themethods and processes described inDOE-O460.1A, Packaging andTransportation Safety, and its associatedguide and DOE-O461.1, Packaging andTransportation of Materials of NationalSecurity Interest, and its associatedmanual, as acceptable ways to satisfythe rule requirements for transportationactivities covered by the provisions ofthis rule.

830.2, Exclusions

E. Comment:A commentor stated thatan exclusion to the requirements of thisrule should be provided for the mixedplutonium-uranium oxide fuelfabrication and irradiation facilities forthe period prior to licensing by theNuclear Regulatory Commission (NRC).

Response:We already exclude anyactivity licensed by the NRC inparagraph 830.2(a). The NRC haslicensing and related regulatoryauthority for any facility under contractwith DOE that is used for the expresspurpose of fabricating mixedplutonium-uranium oxide nuclearreactor fuel for use in a commercialnuclear reactor licensed under the AEA,other than any such facility that isutilized for research, development,demonstration, testing or analysispurposes. See Section 3134(a) of theStrom Thurmond National Defense

Authorization Act for Fiscal Year 1999(Pub. L. 105261) which amends theEnergy Reorganization Act of 1974 toadd Section 202(5) (42 U.S.C. 5842). Thedesign and construction of thesefacilities will be required to meet NRCnuclear safety regulations and,therefore, we are revising 830.2 tomake clear that we are excluding thesefacilities from the provisions of 10 CFRPart 830. This exclusion is similar to theexclusion for activities under theNuclear Waste Policy Act.

830.3, Definitions

F. Comment:A commentor stated thatthe terms safety analysis,documented safety analyses, andhazard analyses are usedinconsistently in the definitions ofsafety class structures, systems, andcomponents; safety significantstructures, systems, and components;and safety structures, systems, andcomponents.

Response:We are revising the wordsDocumented safety analysis to safetyanalyses to make the definitionconsistent with those for safetystructures, systems, and components

and safety significant structures,systems, and components.

G. Comment:A number ofcommentors noted that some terms usedin the rule, such as the terms limitedoperational life and short remainingoperational period are not defined inthe rule and guidance should beprovided on what these terms mean.

Response:We agree with thecomment and we will address these andother terms in the implementationguides for this rule.

830.7, Graded Approach

H. Comment:A number ofcommentors raised questions regardingthe use of the graded approach and theappropriate place to document it.

Response:We received a number ofcomments requesting us to clarify wherea contractor must use a graded approach

and how the graded approachdocumentation should be submitted. Asstated in the preamble to the InterimFinal Rule, contractors are alreadyrequired to implement the qualityassurance requirements using a gradedapproach. In the appendix, we statedthat DOE expects a contractor to use agraded approach to develop adocumented safety analysis anddescribe how the graded approach wasapplied. The preamble provided thatuse of the graded approach is notappropriate in implementing the USQprocess or in implementing technicalsafety requirements. We are revising the

requirements in 830.7 to add asentence to clarify that the gradedapproach is not appropriate inimplementing the USQ process or inimplementing technical safetyrequirements. The graded approachremains applicable to theimplementation of quality assuranceand to the documented safety analysis.

We also received commentsconcerning the documentationrequirements explaining how the gradedapproach was applied. Section 830.7requires a contractor to document the

basis of the graded approach used and

to submit that documentation to DOE.While the rule does not prescribe whenand where such documentation should

be submitted, it is expected that thedocumentation and justification forgrading would be submitted in thedocuments in which it is used. Gradingmethodology and its application wouldthen be reviewed by the DOE officialswho have the authority to approve thedocuments. Grading approaches for site-wide programs or facility-specificapplications are explained further inguidance documents.

Subpart A, Quality Assurance

I. Comment:Several commentsexpressed concern that failure toperform work consistent with allcontract requirements might besubject to enforcement actions under theprovisions of the Price-AndersonAmendments Act of 1988 (PAAA).

Response:Paragraph 830.122(e)(1) ofSubpart A of the rule requirescontractors to: Perform work consistentwith technical standards, administrativecontrols, and other hazard controlsadopted to meet regulatory or contract


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requirements, using approvedinstructions, procedures, or otherappropriate means. However, both thisrule and the DOE PAAA enforcementprocess in 10 CFR Part 820 are limitedto contractor activities that affect, ormay affect, the safety of DOE nuclearfacilities. Thus, contract requirementsthat do not have an effect on nuclear

safety are not subject to the workprocess provisions of Subpart A of thisrule and will not be subject to PAAAenforcement. DOE has other contractremedies to address noncompliancewith contract requirements and workprocesses that have no affect on nuclearsafety.

J. Comment:A number of commentsquestioned how the work processrequirements apply to subcontractorsand suppliers.

Response:Section 830.121(a) isexplicit that all contractors, includingsubcontractors and suppliers, mustconduct work in accordance with thequality assurance criteria listed in 830.122, including the work processescriteria in paragraph 830.122(e).Moreover, the general rule in paragraph830.4(a) is clear that subcontractors andsuppliers may not take any actioninconsistent with the requirements inPart 830. In addition to these directrequirements, paragraph 830.121(c)(4)makes the prime contractor responsiblefor ensuring subcontractors andsuppliers satisfy the quality assurancecriteria of paragraph 830.122(e). DOEexpects that in most cases, primecontractors would satisfy this

requirement through the flowdown ofrequirements and standards inprocurement documents. The primecontractor will be subject to regulatoryenforcement if a subcontractor orsupplier does not meet the qualityassurance criteria when providing itemsand services that could affect nuclearsafety of DOE nuclear facilities. Thisresponsibility of the prime contractor,however, does not relieve thesubcontractors and suppliers from therequirements imposed directly uponthem.

K. Comment:A number of

commentors asked why DOE isrequiring contractors to identifyconsensus standards that are used in theQuality Assurance Program (QAP).

Response:DOE has a long history ofrequiring the use of appropriate nationaland international standards forimplementing its quality assurancerequirements. DOE is stronglycommitted to this philosophy to ensurethat its contractors develop andimplement effective and efficient QAPs.Each DOE quality assurance criterion isstated as a performance expectation and

does not specify the methods to achievethe desired performance result. Nationaland international standards (e.g., ASMENQA1, ASQ E4, or ISO 9001) andtheir supplemental guidance include anumber of proven methods forachieving DOEs performanceexpectations. DOE has found caseswhere failure to use these standards to

develop implementing processes has ledto noncompliance with the DOE qualityassurance criteria. DOE is concernedthat all of its contractors are not takingfull advantage of the benefits standardsoffer. Use of national and internationalstandards will help contractors todevelop effective and efficient QAPsthat are also aligned with theircustomers and suppliers QAPs. TheDOE implementation guide for thequality assurance requirements in therule(DOEG414.12) includes adiscussion of standards use andreferences to the most widely accepted

national and international standards forquality assurance. Contractor use of thisimplementation guide and the clearidentification and the documented useof standards will also help DOE meet itsresponsibilities to review contractorQAPs to ensure that they meet the rulerequirements and to oversee contractorsto ensure that they fully implementtheir DOE-approved QAPs.

Subpart B, Safety Basis

L. Comment:A commentor stated that 803.201 does not add to the rulessubstantive requirements, and becausethe word work is not defined, it could

lead to unjustified applications or toonarrow interpretations.

Response:Other sections of the safetybasis requirements (Subpart B) definethe requirements for derivation anddocumentation of the safety basis for anuclear facility. Section 803.201requires that the activities within themmust be conducted in accordance withthe safety basis. It is essential to havethis element for the safety basisrequirements be more than a paperexercise.

M. Comment:Several commentorsasked how the authorization basis is

different from the safety basis.Response:The rule defines the safetybasis as the documented safety analysisand the hazard controls that providereasonable assurance that a DOE nuclearfacility can be operated safely and in amanner that adequately protectsworkers, the public, and theenvironment. The authorization basis isdefined in DOEG450.41A, IntegratedSafety Management System Guide forUse with Safety Management SystemPolicies (DOEP450.4, DOEP450.5,and DOEP450.6); the Functions,

Responsibilities, And AuthoritiesManual (DOEM411.11B); and theDepartment of Energy AcquisitionRegulation (DEAR) 48 CFR 970.52231,as safety documentation that supportsthe decision to allow a process orfacility to operate. Included arecorporate operational andenvironmental requirements as found in

regulations and specific permits, and,for specific activities, work packages orjob safety analyses. In general, the safety

basis as defined in the rule is a subsetof the authorization basis as theauthorization basis includes documentsrelating to environmental issues, such aspermits, as well as safetydocumentation.

N. Comment:Several commentorsasked why DOESTD1027 is listed asa requirement for hazard categorization,instead of a safe harbor method.

Response:In general, each of the safeharbor standards listed in Table 2 ofAppendix A to Subpart B of the rule can

be effectively applied to specified typesof facilities and activities. In allowingthe contractor to choose the appropriatesafe harbor standard for developing thesafety basis, DOE expects the contractorto select the standard that best fits theapplication. However, DOE wantscontractors to be consistent whendetermining the hazard classification forits nuclear facilities; hence we arerequiring the consistent use of DOESTD1027 which has an establishedhistory for this purpose.

O. Comment:A commentor askedwhat is a below hazard category 3

nuclear facility.Response:In DOESTD1027, these

facilities are categorized as having nopotential for significant offsite, onsite,or localized consequences. A belowhazard category 3 nuclear facility is aDOE facility or activity that meets thedefinition of a nuclear facility but doesnot meet the threshold in DOESTD1027 for a hazard category 3 nuclearfacility. These facilities are sometimesreferred to as radiological facilities.See also Table 1 in Appendix A toSubpart B of the rule.

P. Comment:Two commentors

questioned a statement in the preambleto the Interim Final Rule, in paragraphIII.D on segmentation that said If ahazardous materials could betransported to other segments bycommon confinement systems or thelack of other physical barriers, thefacility cannot be segmented for thepurposes of this rule.

Response:We agree that the statementcould be misleading and the individualcircumstances would need to beevaluated to determine the effect onoperations in the other segment before


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making the determination of whethersegmentation would be permitted forpurposes of categorizing the facility andestablishing an appropriate safety basis.Additional discussion on segmentingnuclear facilities can be found in DOESTD1027.

We emphasize, however, that inconsidering segmentation a contractor

must be mindful of its overridingobligation to ensure adequate protectionof workers, the public, and theenvironment. A contractor will have the

burden of proof to demonstrate thatsegmentation is appropriate.

Q. Comment:A commentor stated thatUSQ determinations related to potentialinadequacies of the safety analysis(PISA) are not always done in a timelymanner and a definite time period forthe performance of a USQ determinationshould be provided in paragraph830.203(e)(3).

Response:The implementation guidefor the USQ requirements of the rule(DOEG424.X) will provide DOEsexpectation that the contractors USQprocedure should define the period forthe performance of a USQ determinationrelated to a PISA and that this timeperiod should be on the order of days,not weeks or months.

R. Comment:Several commentorsasserted that a PISA should not beclassified as a USQ until a USQdetermination confirms that the safetyanalysis is inadequate.

Response:The fact that the safetyanalysis could be inadequate, either

because of a deficiency in the analysis

or because of an as-found condition,indicates that there is a safety questionthat has not yet been reviewed (in otherwords, a USQ). When a contractordiscovers a PISA, DOE requires thecontractor to take action to place thefacility in a safe condition and to notifyDOE of the potential inadequacy. Theperformance of a subsequent USQdetermination is to confirm a positiveUSQ determination or a negative USQdetermination through the applicationof the risk-related criteria for a USQ. Ifthe finding is negative, this wouldsupport a request to DOE to remove any

operational restrictions imposed whenthe PISA was discovered.S. Comment:Section 830.203 requires

contractors for existing nuclear facilitiesto continue to use their existing DOE-approved USQ procedure. Onecommentor asked what it should do ifDOE has not yet approved its USQprocedure.

Response:We have deleted the wordDOE-approved from the requirement.Contractors are expected to continue touse their existing USQ procedurespending DOE approval of the USQ

procedure to be submitted to DOE forapproval by April 10, 2001 under therule.

T. Comment:The definition of a USQin 830.3 of the rule states that asituation involves a USQ if a margin ofsafety could be reduced. A commentorproposed that the margins of safetydescribed in the bases appendix to be

considered should be limited to themargins of safety described in the basessection of the technical safetyrequirements.

Response:Not all nuclear facilities arerequired to have technical safetyrequirements. For example, certainenvironmental restoration activities arenot required to develop technical safetyrequirements. The safety basisimplementation guides will clarify howthe margin of safety criterion should beimplemented.

U. Comment:A commentor stated thatparagraph 830.204(b)(2), should specifythat the documented safety analysismust address both hazards for thefacilities and the activities therein,instead of just the hazards associatedwith the facility.

Response:We agree. In fact, thedefinition for a nonreactor nuclearfacility includes facilities, activities, andoperations. No change to the rule isnecessary.

V. Comment:Several commentorsquestioned why a contractor mustsubmit a preliminary documented safetyanalysis for a major modification ratherthan using the USQ process to addressthe changes.

Response:Several commentorsrecommended that contractors use theUSQ process and modify an existingdocumented safety analysis, rather thansubmitting a preliminary documentedsafety analysis for a major modification.This suggestion would defeat thepurpose of the review and approval ofthe safety aspects of design of themodification prior to procurement andconstruction, which is to ensure thatDOE agrees with the design before themodification is implemented. If thecontractor proceeded to modify theexisting documented safety analysis for

the facility and submit it for approval,prior to design and construction, thedocumented safety analysis would beinstantly out of compliance because itwould no longer reflect the currentconfiguration of the nuclear facility.

W. Comment:Several commentorsindicated that by tying the definition fora major modification to the initialoperation date, rather than the designdate, contractors could be required todevelop preliminary documented safetyanalyses for major modifications thatwere already designed by now and

possibly under construction, and forwhich documented safety analysiswould also be required. A commentorrecommended that the requirement for apreliminary documented safety analysesfor a major modification or new facility

be linked to the initiation of conceptualdesign.

Response:The purpose of the

preliminary documented safety analysisis to ensure that DOE and the contractoragree on design considerations duringthe design and early constructionphases of the modification. We are,therefore, amending 830.206 to applyto hazard category 1, 2, and 3 new DOEnuclear facilities and majormodifications for which construction

begins after December 11, 2000.X. Comment:A commentor stated that

the preliminary documented safetyanalysis should identify safety systemsin addition to safety programs.

Response:Safety systems will, of

necessity, be identified as part of thesafety analysis that derives the aspectsof design that are necessary to satisfythe nuclear safety design criteria. This isexpressed in the definition ofpreliminary documented safety analysis.

Y. Comment:Several commentorsasked if a preliminary documentedsafety analysis is needed forenvironmental restoration, anddecontamination and decommissioning?

Response:As stated in paragraph F.6of Appendix A to Subpart B of the rule,as a general matter, DOE does not expectpreliminary documented safety analyses

to be needed for activities that do notinvolve significant construction such asenvironmental restoration activities,decontamination and decommissioningactivities, specific nuclear explosivesoperations, or transition surveillanceand maintenance activities.

Z. Comment:One commentor statedthat we should discuss how theintegrated safety management principleswould be used for design.

Response:The implementation guidefor the documented safety analysis(DOEG421.X, Implementation Guidefor Use in Developing Documented

Safety Analyses to Meet Subpart B of 10CFR Part 830) specifies that apreliminary documented safety analysisshould show how the nuclear safetydesign criteria of DOE Order 420.1(DOEO420.1), Facility Safety, will besatisfied. The implementation guide forDOEO420.1 says that an iterativeprocess between safety analysis anddesign should begin as early as possibleso safety is integrated into the designprocess as early as possible. This isconsistent with the integrated safetymanagement system process.


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AA. Comment:A number ofcommentors asked how contractorsshould address normal and abnormalconditions in a documented safetyanalysis.

Response:Contractors should refer toDOE implementation guides foradditional information on how to meetDOEs expectations regarding the

requirements in this rule. In particular,contractors should refer to DOESTD3009, section 3.3, page 35 for additionalinformation on how to address normaland abnormal conditions in thedocumented safety analysis. Thissection of the standard describes howall modes of normal operation are to beconsidered.

BB. Comment:Several commentorsasked how a contractor should ensurethat a safety basis contains all therequired contents of the rule when usinga safe harbor standard to prepare adocumented safety analysis.

Response:In general, safe harborstandards listed in Table 2 of AppendixA to Subpart B of the rule are thestandards currently used in the DOEcomplex to develop documented safetyanalyses and they reflect years ofexperience developing adequatedocumented safety bases. DOE isconfident that these standards providegood methods for developing adocumented safety analysis. If acontractor uses a safe harbormethodology, that methodology shouldresult in a contractor satisfying theregulatory requirements for a

documented safety analysis. However,the contractor is responsible for meetingthe requirements of the rule, even if ituses a safe harbor standard to prepareits documented safety analysis.

CC. Comment:A commentor askedwhat a contractor should do if itdeveloped a documented safety analysisusing a safe harbor method, but did notmeet every criterion of a safe harbormethod.

Response:As discussed in thepreamble to the Interim Final Rule, if acontractor uses a method other than asafe harbor method it must obtain DOEapproval of the method beforedeveloping the documented safetyanalysis. If a contractor uses a safeharbor method to develop thedocumented safety analysis, but doesnot follow the method completely, thecontractor should request DOE approvalof the method with the specificdeviations identified.

DD. Comment:Section 830.204 of therule does not limit the documentedsafety analysis to only nuclear hazards.Several commentors asked if controlsfor non-nuclear hazards are enforceable.

Response:As stated in paragraph V.Fof the preamble to the Interim FinalRule, we expect our contractors toaddress all radioactive andnonradioactive hazards, as well as thecontrols necessary to provide adequateprotection to the public, the workers,and the environment from thesehazards, in the documented safety

analysis for category 1, 2, or 3 nuclearfacilities. However, as stated in theGeneral Statement of EnforcementPolicy (Appendix A to 10 CFR Part 820),we will only pursue enforcementactions through the procedures in Part820 for those noncompliances that havenuclear safety significance.

EE. Comment:A commentor askedwhy DOE listed criticality safetyrequirements separately in 830.204.

Response:DOE chose to specificallycall out certain content requirements forthe documented safety analysis in therule because of their importance tonuclear safety. Among these are thecriticality safety requirements. Thecriticality safety requirements in 830.204 are consistent with the currentcriticality safety requirements in DOEO420.1 which is listed as a safe harbormethod for the design criteria for a newnuclear facility. In addition, DOEG421.X, Implementation Guide for Use inDeveloping Documented SafetyAnalyses to Meet Subpart B of 10 CFRPart 830, will address the role ofcriticality safety.

FF. Comment:A commentor statedthat we should specifically incorporatethe criticality standards identified in

DOEO420.1 in the requirements forthe documented safety analysis in 830.204.

Response:The rule addresses thisissue in several ways. First, DOEO420.1 is invoked in 830.206 relative tothe design criteria to be used for thepreliminary documented safety analysis.DOEO420.1 addresses the designfeatures important for criticality safety.Second, Appendix A to Subpart Binvokes DOEO420.1 in two places: (1)paragraph F.6 of the appendix describesthe design criteria for a preliminarydocumented safety analysis and (2)

section G of the appendix states thatOrder 420.1 provides DOEsexpectations with respect to fireprotection and criticality safety. DOEG421.X will provide additionaldiscussion of the importance of DOEO420.1 with respect to criticality safetystandards. We believe theserequirements and associated guidanceprovide sufficient direction tocontractors regarding DOEsexpectations for criticality safety.

GG. Comment:A commentor asked ifthe rule permits a documented safety

analysis to reflect a final categorizationthat would permit segmentation or theapplication of unmitigated releaseparameters more appropriate to theactual situation.

Response:Yes. Several commentorsmisinterpreted the requirement in 830.202 for classification according toDOESTD1027 as not allowing for

documented safety analysis to contain afinal categorization that would permitsegmentation or the application ofunmitigated release parameters moreappropriate to the actual situation. Thesuggestion was made to allow for thesemodifications as part of the initialcategorization. However, no change tothe rule is needed because DOESTD1027 does permit these modifications aspart of a safety analysis, and DOESTD3009 calls for final categorization as partof the documented safety analysis.

HH. Comment:Paragraph 830.205(c)should include reference to DOESTD1120.

Response:Section 830.205 does notreference DOESTD1120. However,DOESTD1120 is referenced in Table 2of Appendix A to Subpart B to the ruleas a safe harbor for environmentalrestoration activities. We believe thatthis is the appropriate reference toDOESTD1120 for the rule.

II. Comment:Several commentorsstated that including design features asa section in the technical safetyrequirements, instead of allowing thedesign features to be included in thedocumented safety analysis, isexpensive and provides no safety

benefit.Response:It is important that certaindesign features be included in thetechnical safety requirements. Thedesign features to be included in asection of the technical safetyrequirements are those which areregarded as important in establishingthe safety basis. These design featuresshould not be changed without DOEapproval. Since changes to the technicalsafety requirements must be approved

by DOE, any changes to design featuresidentified as technical safetyrequirements would require prior DOE

approval. If these important designfeatures are just included in thedescription of the facility in thedocumented safety analysis, alterationswould be subject to the USQ process. Ifthe contractor determines that thechange does not involve a USQ, then thechange may not be submitted for priorDOE approval.

JJ. Comment:Several commentorsasked why a contractor is required tosubmit the annual update of thedocumented safety analysis to DOE forapproval when DOE will have already


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approved any changes to beincorporated in the documented safetyanalysis through the USQ process.

Response:DOE requires contractors toobtain DOE approval of the annualupdate of the documented safetyanalysis to assure that both the changesmade pursuant to the USQ process andany changes not covered by the USQ

process have been properly included inthe update. If the USQ process has beenfollowed properly, the annual approvalof the documented safety analysisshould require minimal effort. Theannual update will not require DOE toreview USQs already approved by DOE.

KK. Comment:A commentor asked ifDOE has already approved a safety

basis, does the contractor need toresubmit the safety basis for approval.

Response:Yes. However, if acontractor determines that its currentsafety basis meets the requirements ofthe rule, it may request DOE to approvethat safety basis under the rule throughthe provisions in paragraph 830.207(c).

LL. Comment:A commentor askedwhat safety basis applies if a contractorhas submitted a new safety basis to DOEfor approval as of October 10, 2000, butDOE has not yet approved it.

Response:The effective safety basis isthe DOE-approved safety basis. WhenDOE approves a new safety basis, that

becomes the new effective safety basisas of the date of the approval. We areadding the words, or as approved byDOE at a later date, to paragraph830.207(b) to clarify that a safety basismay be superseded by later revisions

with DOE approval.MM. Comment:Paragraph 830.207(c)states that if a contractor believes thatits current safety basis meets the rule, itshould notify DOE by April 9, 2001 andrequest DOE to approve the safety basisunder the rule. Further, it states that ifDOE does not issue a safety evaluationreport (SER) by October 10, 2001, acontractor must submit a safety basis toDOE for approval. Several commentorssuggested that existing safety baseswhich are asserted to be compliant withthe rule should be assumed to beapproved by DOE if DOE does not issue

an SER by October 10, 2001, instead ofbeing assumed to be deficient. Acommentor also suggested that DOEmight not approve the safety basiswithin 6 months because of lack ofresources.

Response:It is desired that both thecontractor and DOE take positive actionin establishing safety bases under therule. The contractor should maintaincognizance of the status of DOE reviewsand work with DOE to resolve the statusof the safety basis submitted in a timelyfashion. If the safety basis was originally

developed using one of the safe harborsof the rule, the safety evaluation reportfor the safety basis was issuedapproving the safety basis and the safety

basis and the safety evaluation reportare current, then the DOE effort to verifycompliance with rule provisions should

be small.

Appendix A to Subpart BNN. Comment:A commentor stated

that in Appendix A, paragraph G shouldrefer to requirements in DOEO420.1, not expectations.

Response:We agree that theprovisions in DOEO420.1 arerequirements if the order is included ina contract for the facility or if the orderis adopted by the contractor in its workprocesses. If not, the order still providesDOEs expectations.

OO. Comment:A commentor notedthat the sentence preceding Table 3 inAppendix A to Subpart B of the rule

says that Table 3 defines the specificnuclear facilities referenced in Table 2that are not defined in 830.3; however,Table 3 defines both facilities andactivities. Consequently, the commentorstated that the reference should state itdefines facilities or activities.

Response:The commentor is correctthat the table refers to both facilities andactivities. However, the term used isnuclear facilities. Nuclear facilities, asdefined in the rule, includes bothreactor and nonreactor nuclear facilities.The definition of nonreactor nuclearfacilities includes facilities, operations,

and activities. Therefore, no change isrequired.PP. Comment:One commentor stated

that DOE should make the safety basesdocuments available to the public and asecond commentor expressed concernthat DOE protect classified documentsfrom being released.

Response:As stated in the lastparagraph of Appendix A to Subpart B,DOE will maintain a public list on theinternet that provides the status of thesafety basis for each hazard category 1,2, or 3 DOE nuclear facility and, to theextent practicable, provides information

on how to obtain a copy of the safetybasis and related documents for afacility. In accordance with applicablelaws, regulations, and directives, DOEwill not release classified documents tothe public. However, many of the safety

basis documents are not classified and,therefore, can be made available to thepublic.

General

QQ. Comment:A commentor asked, ifthere is no single contractor responsiblefor a facility, who is responsible to

ensure the requirements of the rule aremet?

Response:At some DOE sites,management and operating (M&O)contractors or management andintegration (M&I) contractors areresponsible for ensuring that theresponsibilities of an activity areproperly integrated. In such cases, the

M&O contractor or the M&I contractor,respectively, would be responsible forensuring the requirements at a facility,including the safety bases requirementsof Subpart B of 10 CFR Part 830 are met.For other facilities, DOE may haveassumed the role of the integrator andmay be responsible to ensure that therequirements are met. During anenforcement action, DOE will weigh thefacts and circumstances surrounding anaction to determine the responsibleparty.

RR. Comment:A commentor asked ifDOE expects contractors to modify

contracts and Safety ManagementSystems to include the newrequirements in the rule.

Response:Regulatory requirementsare legal requirements and they applywhether or not they are incorporated incontracts or Safety ManagementSystems. In addition, Department ofEnergy Acquisition Regulation (DEAR)48 CFR 970.52042 (Laws Clause) statesthat a contractor is obligated to complywith applicable Federal, state, and locallaws and regulations, unless relief has

been granted in writing by theappropriate regulatory agency and to

flow down applicable regulations tosubcontractors and suppliers. It furtherstates that omission of any applicablelaw or regulation from List A does notaffect the obligation of the contractor tocomply with such law or regulation.

SS. Comment:A commentor asked ifcontractors and subcontractors arerequired to report defects andoperational events through theOccurrence and Processing ReportingSystem (ORPS).

Response:DOE expects its primecontractors to continue to report defectsand operational events through ORPS,as required by contracts. Use of thissystem may be enforceable through thequality assurance requirements ofSubpart A, but the particularcircumstances of the situation wouldneed to be assessed. Subcontractors willcontinue to report through the primecontractors. Both DEAR 48 CFR970.52231 and the procurementrequirements of Subpart A, requireprime contractors to flowdownrequirements to subcontractors.

TT. Comment:A commentor asked ifexemptions granted to contractors under


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DOE order requirements would beautomatically continued under the rule.

Response:No. New exemptions willneed to be requested under theprovisions of Subpart E of 10 CFR Part820.

IV. Regulatory and ProceduralRequirements

A. Review Under the NationalEnvironmental Policy Act

We have reviewed this amendment to10 CFR Part 830 under the NationalEnvironmental Policy Act (NEPA) of1969 (42 U.S.C. 4321 et seq.) and theCouncil on Environmental Qualityregulations for implementing NEPA (40CFR Part 1500). Prior to publishing thenotice of proposed rulemaking to addPart 830 to Title 10 of the CFR, andunder the NEPA procedures then inexistence, we concluded that thepotential environmental impacts of Part830 would be clearly insignificant. We

decided that neither an environmentalimpact statement nor an environmentalassessment was required in connectionwith the promulgation of this rule.Since that time, we have issuedregulations establishing implementingprocedures for complying with NEPAsrequirements [See 10 CFR Part 1021].We have further considered Part 830under these regulations. The regulationsinclude a list of typical classes ofactions, referred to as categoricalexclusions, that normally do not requirethe preparation of either anenvironmental impact statement or an

environmental assessment. Part 830 iscovered by several categoricalexclusions including, among others,information gathering, data analysis,and document preparation (A9); trainingexercises and simulations (B1.2);routine maintenance activities andcustodial services (B1.3); and sitecharacterization and environmentalmonitoring (B3.1) [See 10 CFR Part1021, Appendices A and B to SubpartD].

We have concluded that theamendment to 10 CFR Part 830 does notrepresent a major federal action having

significant impact on the environmentunder NEPA (42 U.S.C. 4321 et seq.(1976)), the Council on EnvironmentalQualitys regulations (40 CFR Parts150008), and DOEs implementingregulations (10 CFR Part 1021).Therefore, the amendment to this ruledoes not require an environmentalimpact statement or an environmentalassessment pursuant to NEPA.

B. Review Under Executive Order 12866

This regulatory action has beendetermined not to be a significant

regulatory action under ExecutiveOrder 12866, Regulatory Planning andReview (58 FR 51735, October 4, 1993).Accordingly, this action was not subjectto review under that Executive Order bythe Office of Information and RegulatoryAffairs of the Office of Management andBudget (OMB).

C. Review Under Regulatory FlexibilityAct

The Regulatory Flexibility Act, 5U.S.C. 601 et seq., requires that aFederal agency prepare a regulatoryflexibility analysis for any rule forwhich the agency is required to publisha general notice of proposedrulemaking. The requirement to preparean analysis does not apply, however, ifthe agency certifies that a rule will nothave a significant economic impact ona substantial number of small entities. 5U.S.C. 605(b). The impact of the changesto Part 830 are primarily with respect tomajor contractors. Subcontractors andsuppliers are expected to satisfy theprovisions of Part 830 primarily throughthe programs and proceduresestablished by prime contractors.Consequently, the impacts to smallentities with respect to changes to Part830 are expected to be minor. Theeconomic impact on contractors of thisfiling requirement is negligible. On this

basis, DOE certifies that the rule will nothave a significant economic impact ona substantial number of small entitiesand, therefore, no analysis has beenprepared.

D. Review Under the PaperworkReduction Act of 1995

The information collection provisionsof this rule are not substantiallydifferent from those contained in DOEcontracts with DOE prime contractorscovered by this rule and werepreviously approved by the Office ofManagement and Budget (OMB) andassigned OMB Control No. 19100300.Accordingly, no additional Office ofManagement and Budget clearance isrequired by the Paperwork ReductionAct of 1995 (44 U.S.C. 3501 et seq.) andthe procedures implementing that Act, 5

CFR 1320.1 et seq.E. Review Under Executive Order 13132

Executive Order 13132 (64 FR 43255,August 10, 1999), requires agencies todevelop an accountable process toensure meaningful and timely input byState and local officials in thedevelopment of regulatory policies thathave federalism implications. Policiesthat have federalism implications aredefined in the Executive Order toinclude regulations that have substantialdirect effects on the States, on the

relationship between the nationalgovernment and the States, or on thedistribution of power andresponsibilities among the variouslevels of government. DOE hasexamined the changes to Part 830 anddetermined that they do not have asubstantial direct effect on the States, onthe relationship between the national

government and the States, or on thedistribution of power andresponsibilities among various levels ofgovernment. No further action isrequired by Executive Order 13132.

F. Review Under the UnfundedMandates Reform Act of 1995

Title II of the Unfunded MandatesReform Act of 1995, 2 U.S.C. 1531 etseq., requires each Federal agency, tothe extent permitted by law, to preparea written assessment of the effects ofany Federal mandate in an agency rulethat may result in the expenditure byState, local, and tribal governments, inthe aggregate or by the private sector, of$100 million or more (adjusted annuallyfor inflation) in any one year. This ruleamends 10 CFR Part 830, and appliesonly to activities conducted by or forDOE. Any costs resulting fromimplementation of DOEs management,operation, and enforcement of itsnuclear safety program are ultimately

borne by the Federal government.Therefore, the requirements of Title II ofthe Unfunded Mandates Reform Act of1995 do not apply.

G. Review Under Executive Order 12988

With respect to the review of existingregulations and the promulgation ofnew regulations, section 3(a) ofExecutive Order 12988, Civil JusticeReform (61 FR 4729, February 7, 1996)imposes on Executive agencies thegeneral duty to (1) eliminate draftingerrors and ambiguity; (2) writeregulations to minimize litigation; and(3) provide a clear legal standard foraffected conduct rather than a generalstandard and promote simplificationand burden reduction. Section 3(c) ofExecutive Order 12988 requiresExecutive agencies to review regulations

in light of applicable standards insection 3(a) and section 3(b) todetermine whether they are met. DOEhas completed the required review anddetermined that, to the extent permitted

by law, Part 830 meets the relevantstandards of Executive Order 12988.

H. Review Under Small BusinessRegulatory Enforcement Fairness Act of1996

As required by 5 U.S.C. 801, DOE willreport to Congress on the promulgationof the rule prior to its effective date. The


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report will state that it has beendetermined that the rule is not a majorrule as defined by 5 U.S.C. 804(3).

List of Subjects in 10 CFR Part 830

DOE contracts, Environment, Federalbuildings and facilities, Governmentcontracts, Nuclear energy, Nuclearmaterials, Nuclear power plants and

reactors, Nuclear safety, Penalties,Public health, Reporting andrecordkeeping requirements, and Safety.

Issued in Washington, DC on January 4,2001.

T. J. Glauthier,

Deputy Secretary, Department of Energy.

For the reasons set forth in thepreamble, Part 830 of chapter III, title10, of the Code of Federal Regulationsis amended as set forth below.

Accordingly, the interim final rule for10 CFR Part 830 which was publishedat 65 FR 60291 on October 10, 2000 is

adopted as a final rule with minorchanges as set forth below.

1. Part 830 is revised to read asfollows:

PART 830NUCLEAR SAFETYMANAGEMENT

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 AQuality AssuranceRequirements

830.120 Scope.830.121 Quality Assurance Program (QAP).830.122 Quality assurance criteria.

Subpart BSafety 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 830General Statement of Safety Basis Policy

Authority: 42 U.S.C. 2201; 42 U.S.C. 7101et seq.; and 50 U.S.C. 2401 et seq.

830.1 Scope.

This part governs the conduct of DOEcontractors, DOE personnel, and otherpersons conducting activities (includingproviding items and services) that affect,or may affect, the safety of DOE nuclearfacilities.

830.2 Exclusions.

This part does not apply to:(a) Activities that are regulated

through a license by the NuclearRegulatory Commission (NRC) or a Stateunder an Agreement with the NRC,including activities certified by the NRCunder section 1701 of the AtomicEnergy Act (Act);

(b) Activities conducted under theauthority of the Director, Naval NuclearPropulsion, pursuant to Executive Order12344, as set forth in Public Law 10665;

(c) Transportation activities which areregulated by the Department ofTransportation;

(d) Activities conducted under theNuclear Waste Policy Act of 1982, asamended, and any facility identifiedunder section 202(5) of the EnergyReorganization Act of 1974, asamended; and

(e) Activities related to the launch

approval and actual launch of nuclearenergy systems into space.

830.3 Definitions.

(a) The following definitions apply tothis part:

Administrative controls means theprovisions relating to organization andmanagement, procedures,recordkeeping, assessment, andreporting necessary to ensure safeoperation of a facility.

Bases appendixmeans an appendixthat describes the basis of the limits andother requirements in technical safetyrequirements.

Critical assemblymeans specialnuclear devices designed and used tosustain nuclear reactions, which may besubject to frequent core and latticeconfiguration change and whichfrequently may be used as mockups ofreactor configurations.

Criticalitymeans the condition inwhich a nuclear fission chain reaction

becomes self-sustaining.Design features means the design

features of a nuclear facility specified inthe technical safety requirements that, ifaltered or modified, would have asignificant effect on safe operation.

Documentmeans recordedinformation that describes, specifies,reports, certifies, requires, or providesdata or results.

Documented safety analysis means adocumented analysis of the extent towhich a nuclear facility can be operatedsafely with respect to workers, thepublic, and the environment, includinga description of the conditions, safe

boundaries, and hazard controls thatprovide the basis for ensuring safety.

Environmental restoration activitiesmeans the process(es) by which

contaminated sites and facilities areidentified and characterized and bywhich contamination is contained,treated, or removed and disposed.

Existing DOE nuclear facilitymeans aDOE nuclear facility in operation beforeApril 9, 2001.

Fissionable materials means a nuclidecapable of sustaining a neutron-induced

chain reaction (e.g., uranium-233,uranium-235, plutonium-238,plutonium-239, plutonium-241,neptunium-237, americium-241, andcurium-244).

Graded approach means the processof ensuring that the level of analysis,documentation, and actions used tocomply with a requirement in this partare commensurate with:

(1) The relative importance to safety,safeguards, and security;

(2) The magnitude of any hazardinvolved;

(3) The life cycle stage of a facility;(4) The programmatic mission of a

facility;(5) The particular characteristics of a

facility;(6) The relative importance of

radiological and nonradiologicalhazards; and

(7) Any other relevant factor.Hazardmeans a source of danger (i.e.,

material, energy source, or operation)with the potential to cause illness,injury, or death to a person or damageto a facility or to the environment(without regard to the likelihood orcredibility of accident scenarios orconsequence mitigation).

Hazard controls means measures toeliminate, limit, or mitigate hazards toworkers, the public, or the environment,including

(1) Physical, design, structural, andengineering features;

(2) Safety structures, systems, andcomponents;

(3) Safety management programs;(4) Technical safety requirements; and(5) Other controls necessary to

provide adequate protection fromhazards.

Item is an all-inclusive term used inplace of any of the following:appurtenance, assembly, component,

equipment, material, module, part,product, structure, subassembly,subsystem, system, unit, or supportsystems.

Limiting conditions for operationmeans the limits that represent thelowest functional capability orperformance level of safety structures,systems, and components required forsafe operations.

Limiting control settings means thesettings on safety systems that controlprocess variables to prevent exceeding asafety limit.


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Low-level residual fixed radioactivitymeans the remaining radioactivityfollowing reasonable efforts to removeradioactive systems, components, andstored materials. The remainingradioactivity is composed of surfacecontamination that is fixed followingchemical cleaning or some similarprocess; a component of surface

contamination that can be picked up bysmears; or activated materials withinstructures. The radioactivity can becharacterized as low-level if thesmearable radioactivity is less than thevalues defined for removablecontamination by 10 CFR Part 835,Appendix D, Surface ContaminationValues, and the hazard analysis resultsshow that no credible accident scenarioor work practices would release theremaining fixed radioactivity oractivation components at levels thatwould prudently require the use ofactive safety systems, structures, or

components to prevent or mitigate arelease of radioactive materials.Major modification means a

modification to a DOE nuclear facilitythat is completed on or after April 9,2001 that substantially changes theexisting safety basis for the facility.

New DOE nuclear facilitymeans aDOE nuclear facility that beginsoperation on or after April 9, 2001.

Nonreactor nuclear facilitymeansthose facilities, activities or operationsthat involve, or will involve, radioactiveand/or fissionable materials in suchform and quantity that a nuclear or anuclear explosive hazard potentially

exists to workers, the public, or theenvironment, but does not includeaccelerators and their operations anddoes not include activities involvingonly incidental use and generation ofradioactive materials or radiation suchas check and calibration sources, use ofradioactive sources in research andexperimental and analytical laboratoryactivities, electron microscopes, and X-ray machines.

Nuclear facilitymeans a reactor or anonreactor nuclear facility where anactivity is conducted for or on behalf ofDOE and includes any related area,

structure, facility, or activity to theextent necessary to ensure properimplementation of the requirementsestablished by this Part.

Operating limits means those limitsrequired to ensure the safe operation ofa nuclear facility, including limitingcontrol settings and limiting conditionsfor operation.

Preliminary documented safetyanalysis means documentation preparedin connection with the design andconstruction of a new DOE nuclearfacility or a major modification to a DOE

nuclear facility that provides areasonable basis for the preliminaryconclusion that the nuclear facility can

be operated safely through theconsideration of factors such as

(1) The nuclear safety design criteriato be satisfied;

(2) A safety analysis that derivesaspects of design that are necessary to

satisfy the nuclear safety design criteria;and

(3) An initial listing of the safetymanagement programs that must bedeveloped to address operational safetyconsiderations.

Process means a series of actions thatachieves an end or result.

Qualitymeans the condition achievedwhen an item, service, or process meetsor exceeds the users requirements andexpectations.

Quality assurance means all thoseactions that provide confidence thatquality is achieved.

Quality Assurance Program (QAP)means the overall program ormanagement system established toassign responsibilities and authorities,define policies and requirements, andprovide for the performance andassessment of work.

Reactormeans any apparatus that isdesigned or used to sustain nuclearchain reactions in a controlled mannersuch as research, test, and powerreactors, and critical and pulsedassemblies and any assembly that isdesigned to perform subcriticalexperiments that could potentially reachcriticality; and, unless modified by

words such as containment, vessel, orcore, refers to the entire facility,including the housing, equipment andassociated areas devoted to theoperation and maintenance of one ormore reactor cores.

Recordmeans a completed documentor other media that provides objectiveevidence of an item, service, or process.

Safety basis means the documentedsafety analysis and hazard controls thatprovide reasonable assurance that aDOE nuclear facility can be operatedsafely in a manner that adequatelyprotects workers, the public, and the

environment.Safety class structures, systems, andcomponents means the structures,systems, or components, includingportions of process systems, whosepreventive or mitigative function isnecessary to limit radioactive hazardousmaterial exposure to the public, asdetermined from safety analyses.

Safety evaluation reportmeans thereport prepared by DOE to document

(1) The sufficiency of the documentedsafety analysis for a hazard category 1,2, or 3 DOE nuclear facility;

(2) The extent to which a contractorhas satisfied the requirements ofSubpart B of this part; and

(3) The basis for approval by DOE ofthe safety basis for the facility,including any conditions for approval.

Safety limits means the limits onprocess variables associated with thosesafety class physical barriers, generally

passive, that are necessary for theintended facility function and that arerequired to guard against theuncontrolled release of radioactivematerials.

Safety management program means aprogram designed to ensure a facility isoperated in a manner that adequatelyprotects workers, the public, and theenvironment by covering a topic suchas: quality assurance; maintenance ofsafety systems; personnel training;conduct of operations; inadvertentcriticality protection; emergencypreparedness; fire protection; waste

management; or radiological protectionof workers, the public, and theenvironment.

Safety management system means anintegrated safety management systemestablished consistent with 48 CFR970.52231.

Safety significant structures, systems,and components means the structures,systems, and components which are notdesignated as safety class structures,systems, and components, but whosepreventive or mitigative function is amajor contributor to defense in depthand/or worker safety as determinedfrom safety analyses.

Safety structures, systems, andcomponents means both safety classstructures, systems, and componentsand safety significant structures,systems, and components.

Service means the performance ofwork, such as design, manufacturing,construction, fabrication, assembly,decontamination, environmentalrestoration, waste management,laboratory sample analyses, inspection,nondestructive examination/testing,environmental qualification, equipmentqualification, repair, installation, or thelike.

Surveillance requirements meansrequirements relating to test, calibration,or inspection to ensure that thenecessary operability and quality ofsafety structures, systems, andcomponents and their support systemsrequired for safe operations aremaintained, that facility operation iswithin safety limits, and that limitingcontrol settings and limiting conditionsfor operation are met.

Technical safety requirements (TSRs)means the limits, controls, and relatedactions that establish the specific


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parameters and requisite actions for thesafe operation of a nuclear facility andinclude, as appropriate for the work andthe hazards identified in thedocumented safety analysis for thefacility: Safety limits, operating limits,surveillance requirements,administrative and managementcontrols, use and application

provisions, and design features, as wellas a bases appendix.

Unreviewed Safety Question (USQ)means a situation where

(1) The probability of the occurrenceor the consequences of an accident orthe malfunction of equipment importantto safety previously evaluated in thedocumented safety analysis could beincreased;

(2) The possibility of an accident ormalfunction of a different type than anyevaluated previously in the documentedsafety analysis could be created;

(3) A margin of safety could be

reduced; or(4) The documented safety analysismay not be bounding or may beotherwise inadequate.

Unreviewed Safety Question processmeans the mechanism for keeping asafety basis current by reviewingpotential unreviewed safety questions,reporting unreviewed safety questionsto DOE, and obtaining approval fromDOE prior to taking any action thatinvolves an unreviewed safety question.

Use and application provisions meansthe basic instructions for applyingtechnical safety requirements.

(b) Terms defined in the Act or in 10CFR Part 820 and not defined in thissection of the rule are to be usedconsistent with the meanings given inthe Act or in 10 CFR Part 820.

830.4 General requirements.

(a) No person may take or cause to betaken any action inconsistent with therequirements of this part.

(b) A contractor responsible for anuclear facility must ensureimplementation of, and compliancewith, the requirements of this part.

(c) The requirements of this part mustbe implemented in a manner that

provides reasonable assurance ofadequate protection of workers, thepublic, and the environment fromadverse consequences, taking intoaccount the work to be performed andthe associated hazards.

(d) If there is no contractor for a DOEnuclear facility, DOE must ensureimplementation of, and compliancewith, the requirements of this part.

830.5 Enforcement.

The requirements in this part are DOENuclear Safety Requirements and are

subject to enforcement by allappropriate means, including theimposition of civil and criminalpenalties in accordance with theprovisions of 10 CFR Part 820.

830.6 Recordkeeping.

A contractor must maintain completeand accurate records as necessary to

substantiate compliance with therequirements of this part.

830.7 Graded approach.

Where appropriate, a contractor mustuse a graded approach to implement therequirements of this part, document the

basis of the graded approach used, andsubmit that documentation to DOE. Thegraded approach may not be used inimplementing the unreviewed safetyquestion (USQ) process or inimplementing technical safetyrequirements.

Subpart AQuality Assurance

Requirements

830.120 Scope.

This subpart establishes qualityassurance requirements for contractorsconducting activities, includingproviding items or services, that affect,or may affect, nuclear safety of DOEnuclear facilities.

830.121 Quality Assurance Program(QAP).

(a) Contractors conducting activities,including providing items or services,that affect, or may affect, the nuclearsafety of DOE nuclear facilities must

conduct work in accordance with theQuality Assurance criteria in 830.122.

(b) The contractor responsible for aDOE nuclear facility must:

(1) Submit a QAP to DOE for approvaland regard the QAP as approved 90 daysafter submittal, unless it is approved orrejected by DOE at an earlier date.

(2) Modify the QAP as directed byDOE.

(3) Annually submit any changes tothe DOE-approved QAP to DOE forapproval. Justify in the submittal whythe changes continue to satisfy thequality assurance requirements.

(4) Conduct work in accordance withthe QAP.(c) The QAP must:(1) Describe how the quality

assurance criteria of 830.122 aresatisfied.

(2) Integrate the quality assurancecriteria with the Safety ManagementSystem, or describe how the qualityassurance criteria apply to the SafetyManagement System.

(3) Use voluntary consensus standardsin its development and implementation,where practicable and consistent with

contractual and regulatoryrequirements, and identify the standardsused.

(4) Describe how the contractorresponsible for the nuclear facilityensures that subcontractors andsuppliers satisfy the criteria of 830.122.

830.122 Quality assurance criteria.The QAP must address the following

management, performance, andassessment criteria:

(a) Criterion 1Management/Program.

(1) Establish an organizationalstructure, functional responsibilities,levels of authority, and interfaces forthose managing, performing, andassessing the work.

(2) Establish management processes,including planning, scheduling, andproviding resources for the work.

(b) Criterion 2Management/Personnel Training and Qualification.

(1) Train and qualify personnel to becapable of performing their assignedwork.

(2) Provide continuing training topersonnel to maintain their jobproficiency.

(c) Criterion 3Management/QualityImprovement.

(1) Establish and implement processesto detect and prevent quality problems.

(2) Identify, control, and correctitems, services, and processes that donot meet established requirements.

(3) Identify the causes of problemsand work to prevent recurrence as a partof correcting the problem.

(4) Review item characteristics,process implementation, and otherquality-related information to identifyitems, services, and processes needingimprovement.

(d) Criterion 4Management/Documents and Records.

(1) Prepare, review, approve, issue,use, and revise documents to prescribeprocesses, specify requirements, orestablish design.

(2) Specify, prepare, review, approve,and maintain records.

(e) Criterion 5Performance/WorkProcesses.

(1) Perform work consistent withtechnical standards, administrativecontrols, and other hazard controlsadopted to meet regulatory or contractrequirements, using approvedinstructions, procedures, or otherappropriate means.

(2) Identify and control items toensure their proper use.

(3) Maintain items to prevent theirdamage, loss, or deterioration.

(4) Calibrate and maintain equipmentused for process monitoring or datacollection.


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(f) Criterion 6Performance/Design.(1) Design items and processes using

sound engineering/scientific principlesand appropriate standards.

(2) Incorporate applicablerequirements and design bases in designwork and design changes.

(3) Identify and control designinterfaces.

(4) Verify or validate the adequacy ofdesign products using individuals orgroups other than those who performedthe work.

(5) Verify or validate work beforeapproval and implementation of thedesign.

(g) Criterion 7Performance/Procurement.

(1) Procure items and services thatmeet established requirements andperform as specified.

(2) Evaluate and select prospectivesuppliers on the basis of specifiedcriteria.

(3) Establish and implement processesto ensure that approved supplierscontinue to provide acceptable itemsand services.

(h) Criterion 8Performance/Inspection and Acceptance Testing.

(1) Inspect and test specified items,services, and processes usingestablished acceptance and performancecriteria.

(2) Calibrate and maintain equipmentused for inspections and tests.

(i) Criterion 9Assessment/Management Assessment. Ensuremanagers assess their managementprocesses and identify and correctproblems that hinder the organizationfrom achieving its objectives.

(j) Criterion 10Assessment/Independent Assessment.

(1) Plan and conduct independentassessments to measure item and servicequality, to measure the adequacy ofwork performance, and to promoteimprovement.

(2) Establish sufficient authority, andfreedom from line management, for thegroup performing independentassessments.

(3) Ensure persons who performindependent assessments are

technically qualified and knowledgeablein the areas to be assessed.

Subpart BSafety Basis Requirements

830.200 Scope.

This Subpart establishes safety basisrequirements for hazard category 1, 2,and 3 DOE nuclear facilities.

830.201 Performance of work.

A contractor must perform work inaccordance with the safety basis for ahazard category 1, 2, or 3 DOE nuclear

facility and, in particular, with thehazard controls that ensure adequateprotection of workers, the public, andthe environment.

830.202 Safety basis.

(a) The contractor responsible for ahazard category 1, 2, or 3 DOE nuclearfacility 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 nuclearfacility, the contractor responsible forthe facility must:

(1) Define the scope of the work to beperformed;

(2) Identify and analyze the hazardsassociated with the work;

(3) Categorize the facility consistentwith DOESTD102792 (HazardCategorization and Accident AnalysisTechniques for compliance with DOEOrder 5480.23, Nuclear Safety AnalysisReports, Change Notice 1, September

1997);(4) Prepare a documented safetyanalysis for the facility; and (5)Establish the hazard controls uponwhich the contractor will rely to ensureadequate protection of workers, thepublic, and the environment.

(c) In maintaining the safety basis fora hazard category 1, 2, or 3 DOE nuclearfacility, the contractor responsible forthe facility must:

(1) Update the safety basis to keep itcurrent and to reflect changes in thefacility, the work and the hazards asthey are analyzed in the documentedsafety analysis;

(2) Annually submit to DOE either theupdated documented safety analysis forapproval or a letter stating that therehave been no changes in thedocumented safety analysis since theprior submission; and

(3) Incorporate in the safety basis anychanges, conditions, or hazard controlsdirected by DOE.

830.203 Unreviewed safety questionprocess.

(a) The contractor responsible for ahazard category 1, 2, or 3 DOE nuclearfacility must establish, implement, and

take actions consistent with a USQprocess that meets the requirements ofthis section.

(b) The contractor responsible for ahazard category 1, 2, or 3 DOE existingnuclear facility must submit for DOEapproval a procedure for its USQprocess by April 10, 2001. Pending DOEapproval of the USQ procedure, thecontractor must continue to use itsexisting USQ procedure. If the existingprocedure already meets therequirements of this section, thecontractor must notify DOE by April 10,

2001 and request that DOE issue anapproval of the existing procedure.

(c) The contractor responsible for ahazard category 1, 2, or 3 DOE newnuclear facility must submit for DOEapproval a procedure for its USQprocess on a schedule that allows DOEapproval in a safety evaluation reportissued pursuant to section 207(d) of this

Part.(d) The contractor responsible for a

hazard category 1, 2, or 3 DOE nuclearfacility must implement the DOE-approved USQ procedure in situationswhere there is a:

(1) Temporary or permanent changein the facility as described in theexisting documented safety analysis;

(2) Temporary or permanent changein the procedures as described in theexisting documented safety analysis;

(3) Test or experiment not describedin the existing documented safetyanalysis; or (4) Potential inadequacy ofthe documented safety analysis becausethe analysis potentially may not be

bounding or may be otherwiseinadequate.

(e) A contractor responsible for ahazard category 1, 2, or 3 DOE nuclearfacility must obtain DOE approval priorto taking any action determined toinvolve a USQ.

(f) The contractor responsible for ahazard category 1, 2, or 3 DOE nuclearfacility must annually submit to DOE asummary of the USQ determinationsperformed since the prior submission.

(g) If a contractor responsible for ahazard category 1, 2, or 3 DOE nuclear

facility discovers or is made aware of apotential inadequacy of the documentedsafety analysis, it must:

(1) Take action, as appropriate, toplace or maintain the facility in a safecondition until an evaluation of thesafety 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 safetyof the situation to DOE prior toremoving any operational restrictionsinitiated to meet paragraph (g)(1) of thissection.

830.204 Documented safety analysis.(a) The contractor responsible for ahazard category 1, 2, or 3 DOE nuclearfacility must obtain approval from DOEfor the methodology used to prepare thedocumented safety analysis for thefacility unless the contractor uses amethodology set forth in Table 2 ofAppendix A to this Part.

(b) The documented safety analysisfor a hazard category 1, 2, or 3 DOEnuclear facility must, as appropriate forthe complexities and hazards associatedwith the facility:


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(1) Describe the facility (including thedesign of safety structures, systems andcomponents) and the work to beperformed;

(2) Provide a systematic identificationof both natural and man-made hazardsassociated with the facility;

(3) Evaluate normal, abnormal, andaccident conditions, including

consideration of natural and man-madeexternal events, identification of energysources or processes that mightcontribute to the generation oruncontrolled release of radioactive andother hazardous materials, andconsideration of the need for analysis ofaccidents which may be beyond thedesign basis of the facility;

(4) Derive the hazard controlsnecessary to ensure adequate protectionof workers, the public, and theenvironment, demonstrate the adequacyof these controls to eliminate, limit, ormitigate identified hazards, and define

the process for maintaining the hazardcontrols current at all times andcontrolling their use;

(5) Define the characteristics of thesafety management programs necessaryto ensure the safe operation of thefacility, including (where applicable)quality assurance, procedures,maintenance, personnel training,conduct of operations, emergencypreparedness, fire protection, wastemanagement, and radiation protection;and

(6) With respect to a nonreactornuclear facility with fissionable materialin a form and amount sufficient to posea potential for criticality, define acriticality safety program that:

(i) Ensures that operations withfissionable material remain subcriticalunder all normal and credible abnormalconditions,

(ii) Identifies applicable nuclearcriticality safety standards, and

(iii) Describes how the program meetsapplicable nuclear criticality safetystandards.

830.205 Technical safety requirements.

(a) A contractor responsible for ahazard category 1, 2, or 3 DOE nuclear

facility must:(1) Develop technical safetyrequirements that are derived from thedocumented safety analysis;

(2) Prior to use, obtain DOE approvalof technical safety requirements and anychange to technical safety requirements;and

(3) Notify DOE of any violation of atechnical safety requirement.

(b) A contractor may take emergencyactions that depart from an approvedtechnical safety requirement when noactions consistent with the technical

safety requirement are immediatelyapparent, and when these actions areneeded to protect workers, the public orthe environment from imminent andsignificant harm. Such actions must beapproved by a certified operator for areactor or by a person in authority asdesignated in the technical safetyrequirements for nonreactor nuclear

facilities. The contractor must report theemergency actions to DOE as soon aspracticable.

(c) A contractor for an environmentalrestoration activity may follow theprovisions of 29 CFR 1910.120 or1926.65 to develop the appropriatehazard controls (rather than theprovisions for technical safetyrequirements in paragraph (a) of thissection), provided the activity involveseither:

(1) Work not do