top-001-13, development of compliance determination methods … · 2012. 11. 19. · a center for...

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CENTER FOR NUCLEAR WASTE Proc. TOP-001-013

REGULATORY ANALYSESRevision 0

TECHNICAL OPERATING PROCEDURE of 13

Title TOP-001-013 Development of Compliance Determination Methods

EFFECTIVITYRevision 0 of this procedure became effective on 11/1 2/93. This procedure consists ofthe pages and changes listed below.

Paae No.

All

Chanae No.

0

Date Effective

11/12/93

SUPERo- 7ENDSUPR1k- r L a -D

Supercedes Procedure No. N/A

Approvals

Written by te

Robert D. Brient

Quality Ask

Bruce Mab

CNWRA Form TOP-1 (8/93)

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CENTER FOR NUCLEAR WASTE Proc. TOP-001-01:

REGULATORY ANALYSES Revision 0


DEVELOPMENT OF COMPLIANCE DETERMINATION METHODS

1 PURPOSE

The purpose of this procedure is to describe the format, content, and method fordevelopment of Compliance Determination Methods (CDMs) for the High-Level WasteRepository license application review. A CDM, together with portions of the associatedCompliance Determination Strategy (CDS), constitutes an individual review plan that the staff willuse to review the associated section of the Department of Energy's (DOE) license application,determine compliance, and make evaluation findings. This procedure addresses the requirementsof the Center for Nuclear Waste Regulatory Analyses (CNWRA) Quality Assurance Manual(CQAM) Section 3.

2 DEFINITIONS

2.1 Acceptance Criteria. The technical bases for determining compliance with the ApplicableRegulatory Requirements.

2.2 Applicable Regulatory Requirements. As identified during the development of CDS,Applicable Regulatory Requirements are the individual citations from 10 CFR Part 60 associatedwith a Regulatory Requirement Topic (RRT).

2.3 Compliance Determination Method (CDM). The Nuclear Regulatory Commission's(NRC) review procedure for determining DOE compliance with the Applicable RegulatoryRequirements. Each CDM establishes the review procedure, acceptance criteria, reviewresponsibilities, interfaces, example evaluation findings, and supporting rationales.

2.4 Compliance Determination Strategy (CDS). The general approach or overall plan of theNuclear Regulatory Commission (NRC) for determination of compliance with the ApplicableRegulatory Requirements, along with supporting rationales. Each CDS establishes the scope anddepth of the compliance determination for an RRT.

2.5 Evaluation Finding. The staff's summary of the results and basis for the compliancedetermination for a license application review. Findings will be prepared for acceptance reviewsfor RRTs and for either general information or compliance reviews (as defined in TOP-001-1 1:Development of Compliance Determination Strategies) for each Applicable RegulatoryRequirement. Evaluation findings for general information and compliance reviews will bedocumented in NRC's Safety Evaluation Report (SER) of the license application. Example

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REGULATORY ANALYSES Revision °


evaluation findings (EEF) are prepared during CDM development to show the types of potentialevaluation findings that are sought.

2.6 License Application Review Plan (LARP). The document which provides detailedguidance to the NRC staff on how to conduct the license application review. The LARP consistsof individual review plans associated with individual RRTs. Review plans include portions of theassociated CDS (e.g., Applicable Regulatory Requirements and review strategies), and of theassociated CDM (e.g., review procedures, acceptance criteria, responsibilities, interfaces,example evaluation findings, and references).

2.7 Regulatory Requirement Topic (RRT). A set of one or more regulatory requirementspertaining to a topic of regulatory interest. Each RRT corresponds to an individual section of theFormat and Content Regulatory Guide (FCRG) and to an individual review plan in the LARP.

2.8 Review Procedure. The sequence of steps to be used to determine whether DOE hascomplied with the Applicable Regulatory Requirements.

3 RESPONSIBILITIES

3.1 The Deputy Technical Director for Systems Engineering and Integration is responsiblefor implementation of this procedure.

3.2 Members of CDM development groups are responsible for preparing CDMs inaccordance with this procedure.

4 CDM DEVELOPMENT GROUP MEMBERSHIP, TECHNICAL BACKGROUND,AND TRAINING

CDM development group members shall be assigned by the management of the NRCDivision of High-Level Waste Management (DHLWM) and CNWRA Element Managers, asappropriate. Members shall be familiar with the associated section of the FCRG, the associatedCDS, and other background information pertinent to the CDM and the technical aspects of theCDM. Team members shall be provided with general Systematic Regulatory Analysis (SRA)training and specific training in the application of this procedure.

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TECHNICAL OPERATING PROCEDURE Page A.f-I of 13

5 PROCEDURE

5.1 Due to the inability to fully describe the specific approaches to developing the widevariety of CDMs, this procedure will rely on example (prototype) or generic CDMs to serve asmodels for subsequent development of similar CDMs. (Categories of CDMs may be identified,and within the categories, certain CDMs from a category may be selected as examples or genericCDMs to guide the efficient and consistent development of other CDMs.) Extra attention will berequired for preparing example and generic CDMs to ensure consistency with CDMs from othercategories. As necessary, supplements to this procedure may be prepared to describe thedevelopment approaches or to present generic CDMs for specific CDM categories.

5.2 CDMs shall be prepared in the following format. The format is annotated with formatheadings and CDM paragraph numbers (in bold type), suggested standard language (in italics),and instructions (in standard type) for developing the content of each of the sections. Suggestedstandard language may be modified, appended, and deleted as appropriate.

Start of CDM Outline

COMPLIANCE DETERMINATION METHOD FOR REVIEW PLAN NO._(RRT Title)

The review plan number and title information shall be the same as that of theassociated LARP section and CDS.

3.0 REVIEW PROCEDURES AND ACCEPTANCE CRITERIA:

This section describes the Review Procedures and Acceptance Criteria for the AcceptanceReview and Compliance Reviews.

3.1 Acceptance Review:

In conducting the Acceptance Review for docketing, the staff will compare the information in theLicense Application (LA) concerning (RRT descripdtion) with the corresponding section of theFCRG and with the staff's resolution status of objections to LA submittal in the Open ItemTracking System (01S) and determine if this information meets the following criteria.

CNWRA Form TOP-2




(1) The information presented in the LA is clear, is completely documented consistent with thelevel of detail presented in the corresponding section of the FCRG, and the references have beenprovided.

(2) DOE has either resolved, at the staff level, the NRC objections to LI submittal that apply tothis regulatory requirement topic, or provided all information requested in Section 1.6 of theFCRG for unresolved objections, namely, DOE has:

* identified all unresolved objections

* explained the differences between NRC and DOE positions that have precludedresolution of each objection

* described all attempts to achieve resolution

* explained why resolution has not been achieved

* described the effects of the different positions on demonstrating compliance with10 CFR Part 60

In addition, unresolved objections, individually or in combination with others, will not preventthe reviewer from conducting a meaningful Compliance Review and the Commissionfrom makinga decision regarding construction authorization within the 3-year statutory period.

Instructions:

The scope of acceptance (Type 1) reviews shall include review of pertinentinformation for all Applicable Regulatory Requirements of an RRT.

3.2 Compliance Reviews or General Information Review: (as applicable)

3.2.n (Review Title, see below)

Instructions:a. For each applicable review type, indicate the title of the review as

follows:

Type 2: General Information Review of 10 CFR 60.abc

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CENTER FOR NUCLEAR WASTE Proc. TOP-OO1-O1



CDM Outline (Cont 'd.)

Type 3: Safety Review of 10 CFR 60.abc

Type 4: Detailed Safety Review Supported By Analyses for 10CFR 60.abc for (KTU Titl)

Type 5: Detailed Safety Review Supported By Independent Tests,Analyses, or Other Investigations for 10 CFR 60.abc for(KTU Title)

b. Review procedures and acceptance criteria shall be prepared for thegeneral information review or for each of the compliance review typesidentified in the associated CDS. Compliance review types for anapplicable regulatory requirement shall be presented in the order of theirtype (i.e., Type 3, then Type 4, then Type 5), and Applicable RegulatoryRequirements shall be presented in ascending numerical order of their 10CFR Part 60 citation. Each review procedure, together with theassociated acceptance criteria, shall be organized in an individual sub-paragraph (3.2.n). The order of presentation of review procedures in theCDM does not imply any required sequence to the license applicationreviews.

c. The acceptance criteria may be identified immediately following thecorresponding review procedure step, or the acceptance criteria may beintegrated with the text of the review procedure step.

d. The review procedure and acceptance criteria shall address the threeessential elements of the review: what is to be reviewed, how it will bereviewed, and what standard the staff would use to determine whetherthe reviewed material is acceptable.

e. Elements of the review procedure that are to be developed in the future,such as those concerning regulatory and key technical uncertainties,should be identified as "needing future development" to facilitate trackingthese required actions.

f. Review procedures and acceptance criteria in other CDMs that are applicable tothe CDM being prepared should be referenced.

CNWRA Form TOP-2




CDM Outline (Cont'd.)

g. The following should be considered in developing review procedures.

* Review procedures shall provide the step-by-step methods to beemployed to evaluate the license application for compliance withthose regulatory requirements.

* Review procedures may include investigative or evaluativeprocedures needed to conduct detailed technical reviews (e.g.,tests, application of conceptual models and computer codes, useof expert judgment, and any other modes of inquiry).

* The review procedures should be developed consistent with thecorresponding portions of the FCRG and CDS review strategiesand rationales. The CDM should also be developed consideringhow the review strategies and review procedures and acceptancecriteria will be combined into a review plan of the LARP. Asnecessary, the CDS may be revised to address theseconsiderations.

* The list of regulatory uncertainties should be reviewed to identifythose applicable to the subject CDM and to verify that these havebeen appropriately addressed. If not, these shall be addressed inthe review procedure of the CDM. (DOE will be notified of thestaff's position with respect to resolution of the regulatoryuncertainty.)

* Review procedures shall include steps requiring that results ofthe compliance determinations be documented to serve as thebasis for the evaluation findings.

* Justification and rationale shall be prepared as indicated in theinstructions for CDM Section 3.3 (Rationales) for unusual ornovel review techniques.

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h. The following should be considered in developing acceptance criteria.

e Acceptance criteria must be specifically related to the ApplicableRegulatory Requirements.

* Acceptance criteria must be developed to allow for conclusionswith respect to acceptability or compliance. Acceptance criteriashould be based on what is needed for the staff to develop abasis for its findings. To facilitate documentation of the basisfor findings, it may be advantageous to consider the logical orderin which the basis for findings would be stated.

* Acceptance criteria should be based on the following to thegreatest extent possible: (i) design bases or design criteriaspecified in 10 CFR Part 60, (ii) applicable High-Level WasteManagement staff technical positions, (iii) applicable NUREGsor regulatory guides, (iv) applicable standards or practices, and(v) referenced regulations.

* In areas where the acceptance criteria cannot be as clearlydefined or applicable as the sources listed above, acceptancecriteria shall be developed. Developed acceptance criteria shouldgenerally provide for a conservative determination ofcompliance, and the basis for selecting the acceptance criteriashall be documented in the rationales as described in Section 3.3.

i. Additional subsections (i.e., 3.2.n.n) may be identified for review types havingseveral distinct review topics.

3.3 Rationale for Review Procedures and Acceptance Criteria:

3.3.n Rationale for (Review Title as identified in the corresponding section of 3.2.n):

Instructions:a. Rationales for the selection of compliance review procedures and

acceptance criteria should be prepared. Rationales shall be presented inthe same order (and numbering) as the corresponding review procedure.

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* When a review technique or acceptance criterion is standard practice forthe discipline, either a documented standard should be referenced, orwhere none exists, a description of where and how the technique orcriterion is used should be given.

* The rational should explain why a technique or criterion that is standardfor one industry or circumstance is appropriate for a repository.

* When techniques or criteria are novel or unusual, more detailedjustification of their application is needed.

b. Rationales should include the following:

* The technical justification for selecting a specific reviewtechnique. This is particularly important where more than onetechnique may be available or where the technique is novel orhas been developed by the staff.

* An explanation of the manner in which a review technique isbeing applied. Again, this is important where more than onechoice exists or where the application is not standard.

* Justification for any limitations to application of a reviewtechnique.

* Explanations of any uncertainties or controversy in theapplication of a review technique.

* Justification for the selection of an individual acceptancecriterion.

* If an acceptance criterion does not represent accepted practice orstandards, the rationale should document the development of theacceptance criterion and delineate its applicability.

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TECHNICAL OPERATING PROCEDURE Page .10 of 13


4.0 IMPLEMENTATION:

4.1 Review Responsibilities:

The review responsibilities for this review plan are as follows:

Lead:

Support:

(Division-Section. using acronyms for current HLWM branchesand sections)

(Division-Section. using acronyms for current HLWM branchesand sections) The Office of the General Counsel (OGC) shouldbe consulted as appropriate.

Instructions:Review Responsibilities shall identify the lead and support organizationsresponsible for performing the reviews.

4.2 Interfaces:

4.2.1. Input Information [see (i), below](1) (Describe the required information)(2) ...

4.2.2. Output Information [see (ii), below](1) (Describe the outgoing information)(2) ...

Review Plan No.

Review Plan No.

Instructions:Interfaces between this and one or more other review plans shall be brieflydescribed in this format for (i) the information needed from other reviews (input)and (ii) the information from this review expected to support other reviews(output).

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CDM Outline (Cow'd.)

5.0 EXAMPLE EVALUATION FINDINGS

5.1 Finding for Acceptance Review:

The NRC stafffinds that the information presented by DOE on (the RRTdescription) is acceptable(not acceptable) for docketing and compliance review.

5.2 Finding(s) for General Information or Compliance Review(s): (as applicable)

5.2.n Finding for 10 CFR 60.abc

The NRC staff inds that the (regulatory requirement description) has (has not) been acceptablydemonstrated and that there is (is not) reasonable assurance that the regulatory requirements of10 CFR 60. abc will be met for (the specific aspects of the regulatory requirement dealt with inthis review).

or

The NRC stafffinds/concludes that DOE's proposed lanalyses of /conclusionsregarding (regulatory requirement description are acceptable (not acceptable) and that there is(is not) reasonable assurance that the regulatory requirements of 10 CFR 60.abC will be met for(the specific aspects of the regulatory requirement dealt with in this review).

or, if DOE has applied for an exemption under 10 CFR 60.6

The NRC staff has determined that grant of an exemption from the requirements of 10 CFR 60. abis authorized by law, will not endanger life or property or the common defense and security, andis otherwise in the public interest.

Therefore, the NRC staff concludes that the exemption should be granted.

or

The NRC staff has determined that grant of an exemption from the requirements of 10 CFR 60.absis not authorized by law, would endanger the life or property or the common defense andsecurity, or is otherwise not in the public interest.

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TECHNICAL OPERATING PROCEDURE Page -12 of 13

CDM Outlne (Cont 'd.)

Therefore, the NRC staff concludes that the exemption should not be granted.

Instructions:a. Example Evaluation Findings (EEFs) shall be prepared for each of the

Applicable Regulatory Requirements of an RRT. The EEFs shall belisted in ascending order of the applicable regulatory requirementnumerical citation. Normally, the EEFs will be placed in Section 5 of theCDM. For greater clarity in CDMs with many Applicable RegulatoryRequirements, the EEF may be located immediately following the reviewprocedure(s) and acceptance criteria of an applicable regulatoryrequirement.

b. The EEF shall identify the applicable regulatory requirement togetherwith a declaration of the acceptability (or unacceptability) of DOE'sdemonstration of compliance. For regulatory requirements that areapplicable to more than one RRT, the declaration of adequacy shallinclude an indication of the specific aspect of the regulatory requirementthat was the subject of the review.

c. Only Example Evaluation Findings are given here. The EvaluationFinding resulting from the staff's review of the LA will be documentedin the Safety Evaluation Report (SER), along with the basis for thefindings, which will be built upon the reviewer's documentation of whathas been reviewed and whether each acceptance criterion has been met.

d. If DOE applies for an exemption, the staff will need to considerthe criteria in 10 CFR 50.12 in determining whether anexemption should be granted. Although 10 CFR 50.12 does notlegally apply, it should be useful to staff decision-making.

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6.0 REFERENCES

Instructions:References shall be listed in alphabetical order, using the formatsestablished for CDS development. The beginning and endingpage numbers of the relevant material should be identified.

End of CDM Outline

6 CDM REVIEW AND APPROVAL

6.1 The completed (draft) CDM shall be reviewed by the NRC and the CNWRA. TheCNWRA reviews shall be conducted in accordance with QAP-002.

6.2 After approval by the NRC and the CNWRA, the CDM shall be entered into the databasefor Systematic Regulatory Analysis-related products and information, as specified byTOP-001-15.

7 RECORDS

7.1 CDMs, revisions, and changes shall be maintained as QA Records in accordance withCQAM Section 17.

7.2 Review documentation developed by the CNWRA as a result of conducting CDM-relatedactivities shall be maintained as QA Records as specified in QAP-002.

CNWRA Form TOP-2

Proc. TOP-001-013

CENTER FOR NUCLEAR WASTERevision I

REGULATORY ANALYSESPage 1 of 1

TECHNICAL OPERATING PROCEDURE

Title DEVELOPMENT OF COMPLIANCE DETERMINATION METHODS

EFFECTIVITYRevision 1 of this procedure effective on makes this procedure obsolete. This procedure consistsof the pages and changes listed below.

Page No.

1

Change No.

0

Date Effective

12/08/2000

NOTE: This procedure, TOP-001 -013, has been withdrawn from use at the CNWRA.

Please remove and destroy the referenced procedure in your notebook/holder and return theacknowledgment page to CNWRA Document Control with your signature and date.

'~ADt

Supersedes Procedure No. N/A

Apfkovals

W~tte\ by Date Technical view Date

David/r O Pat Mack~l I __hil (_V

Quality Assurance ( Date Cognizant Directo Date

Bruce Mabrito dh Sagar (_ _

CNWRA Form TOP-1 (8/93)

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