ML20153C682
| ML20153C682 | |
| Person / Time | |
|---|---|
| Issue date: | 05/12/1998 |
| From: | Gray J NRC OFFICE OF THE GENERAL COUNSEL (OGC) |
| To: | Cool D NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20153C648 | List: |
| References | |
| FRN-63FR39526, RULE-PR-72 AF93-1-004, AF93-1-4, NUDOCS 9809240168 | |
| Download: ML20153C682 (20) | |
Text
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I ur UNITED STATES
%,, NUCLEAR REGULATORY COMMISSION
[ o WASHINGTON, D.C. 20555-0001 -
g e
%*****} May 12, 1998 OFFICE OF THE l
GENERAL COUNSEL MEMORANDUM TO: Donald A. Cool, Director 1 Division of Industrial and Medical )
Nuclear Safety, NMSS FROM: Joseph R. GrayNNbh at Associate General Counsel for Licensing and Regulations Office of the General Counsel
SUBJECT:
PROPOSED RULE - EXPAND APPLICABILITY OF PART 72 TO HOLDERS OF, AND APPLICANTS FOR, CERTIFICATES OF COMPLIANCE AND THEIR CONTRACTORS AND SUBCONTRACTORS i
This is to inform you that the Office of the General Counsel has no legal objection to the publication of this proposed rule subject to the attached changes.
Attachment:
As stated
Contact:
E. Neil Jensen, OGC 415-1637 s
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9809240168 980921 PDR PR 72 63FR39526 PDR
$ 0$ 2.967,fg[ Y
The Commissioners 2 The NRC Enforcement Policy and its implementing program have been established to support the NRC's overall safety mission in protecting public health and safety and the environment.
Consistent with this purpose, enforcement actions are intended to be used: (1) as a deterrent to emphasize the importance of compliance with requirements, and (2) to encourage prompt i identification and prompt, comprehensive correction of the violations. Enforcement sanctions I consist of Notices of Violation (NOV), civil penalties, and orders of various types. In addition to i the formal enforcement actions, the NRC also uses related administrative actions such as i Notices of Nonconformance (NON), Confirmatory Action Letters, and Demands for Information to supplement the NRC's enforcement program. The NRC expects licensees and vendors (i.e., l holders of, and applicants for a certificate of compliance) to adhere fa any obligations and commitments resulting from these actions and will not hesitate to iswe appropriate orders to ensure that these obligations and commitments are met.
The Commission approved the staff's rulemaking plan for this rulemaking (SECY-97-214, dated September 24,1997) in a Staff Requirements Memorandum dated November 4,1997.
DISCUSSION-In promulgating Subpart L, the staff intended that selected Part 72 provisions would apply to cask certificate holders and applicants for a cask certificate of compliance (CoC). For example, 9 72.234(b) requires that, as a condition for approval of a certificate of compliance, "(d]esign, fabrication, testing, and maintenance of spent fuel storage casks be conducted under a quality assurance program that meets the requirements of subpart G of this part." However, the quality assurance requirements in Subpart G do not refer to certificate holders, but only to licensees and applicants for licenses. Further, some of the Subpart L regulations apply exp'icitly only to "the applicant,"(e.g., 6 72.232), or to "the cask vendor,"(e.g., 9 72.234(d)(1)),
or are written in the passive voice so that it is not clear who is responsible for meeting the requirement, (e.g., 9 72.236). Although certificates of compliance are legally binding documents, certificate holders or applicants for a CoC and their contractors and subcontractors have not clearly been brought within the scope of Part 72 reguirements. Because the terms 8
- certificate holder"and applicant for a certificate of compliance do not appear in the above-cited y.
Part 72 regulations, the NRC has not had a clear basis to cite these persor 3r violations of Part 72 requirements in the same way it treats licensees. Presently, when the NRC has identified a failure to comply with Part 72 requirements by these persons it has issued an administrative action in the form of an NON rather than enforcement action in the form of an NOV.
4 While it may appear that an NON and an NOV are similar, the staff believes that the issuance of an NOV is preferred because: (1) the issuance of an NOV effectively conveys to both the person violating the requirement and the public that a violation of a legally binding requirement has occurred; (2) the use of graduated severity levels associated with an NOV allows the NRC to effectively convey to both the person violating the requirement and the public a clearer perspective on the safety and regulatory significance of the violation; and (3) violation of a
' regulation reflects the NRC conclusion that potential risk to public health and safety could exist and this evidence can then be used to support the issuance of further enforcement sanctions e such as orders.
l enforcement action is intended to reflect the seriousness of the violation involved. An NOV is a i
j written notice setting forth one or more violations of a legally binding requirement.
l Discussion -
In promulgating Subpart L, the Commission intended that selected Part 72 provisions would apply to cask certificate holders and applicants for a cask certificate of compliance (CoC). For example, @ 72.234(b) requires that, as a condition for approval of a certificate of compliance, "[d]esign, fabrication, testing, and maintenance of spent fuel storage casks be conducted under a quality assurance program that meets the requirements of subpart G of this part." However, the quality assurance requirements in Subpart G do not refer to certificate holders, but only to licensees and applicants for licenses. Further, some Subpart L regulations apply explicitly only to "the applicant," (e.g., S 72.232) or to "the cask vendor," (e.g.,
@ 72.234(d)(1)). Some of these provisions are written in the passive voice so that it is not clear who is responsible for meeting the requirement, (e.g., S 72.236). Although certificates of compliance are legally binding documents, certificate holders or applicants for a CoC and their contractors and subcontractors have not clearly been brought within the scope of Part 72 requirements. Because the termstertificate holder and applicant for a certificate of compliance
- 7 do not appear in the above-cited Part 72 regulations, the NRC has not had a clear basis to cite these persons for violations of Part 72 requirements in the same way it treats licensees. When the NRC has identified a failure to comply with Part 72 requirements by these persons, it has issued a NON rather than NOV.
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Although a NON and a NOV appear to be similar, the Commission preferstthe issuance K of a NOV because: (1) the issuance of a NOV effectively conveys to both the person violating 4
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i the requirement and the public that a viola' in of a legally binding requirement has occurred; (2) the use of graduated severity levela associated with a NOV allows the NRC to effectively convey to both the person violating the requirement and the public a clearer perspective on the safety and regulatory significance of the violation; and (3) violation of a regulation reflects the NRC conclusion that potential risk to public health and safety could exist. This evidence can then be used to support the issuance of further enforcement sanctions such as orders.
Over the last 2 years, the Commission has observed problems with the performance of several certificate holders and tneir contractors and subcontractors. These problems have occurred in design, design control, fabrication and corrective action areas. Problems in these areas are typically covered under the quality assurance program. In FY 1996, the NRC staff identified numerous instances of nonconformance by certificate holders and their contractors and subcontractors failing to comply with requirements. The Commission has concluded that use of the additional enforcement sanctions which are available in the NRC Enforcement Policy are required to address the performance problems which have occurred in the spent fuel storage industry. Consequently, the Commission would revise Part 72 to explicitly make certificate holders and applicants for a CoC, and their contractors and subcontractorsjsubject toX those requirements and thereby allow the use of enforcement sanctions against these persons,
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rather than administrative sanctions. The Commission believes that these amendrnents will have the effect of allowing both the public and those persons designing and building spent fuel storage casks to clearly understa d the expectations which have been placed on them.
The proposed rulemaking will primarily focus on amending regulations in Subpart G to explicitly include certificate holders, applicants for a CoC, and their contractors and subcontractors. Further, in Subpart L, this proposed rulemaking would also revise SS 72.232, 72.234, and 72.236 to clarify who is responsible for ensuring that these requirements are met.
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l safety from cask deficiencies and to ensure that a licensee (who is responsible for evaluating 1
and resolving the problem) completes those actions in a timely manner. The Commission l
believes that this regulation need only apply to casks which have been delivered to licensees 1 (i.e., they are out of the control of the certificate holder). Any deficiencies identifie'd in casks over ;<
which the certificate holder still has custody would be identified in accordance with the certificate holder's quality assurance program. Overall, this new section would be similar to the 1
reporting and recordkeeping requirements imposed on licensees in 6 72.75 and 72.80.
Discussion of Proposed Amendments by Section l
Subpart A - General Provisions 6 72.2 Scope.
The term spent fuel storage cask would be added to paragraph (b) of this section. This is a conforming amendment.
@ 72.3 Definitions.
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Definitions for spent fuelstorage cask, certificate holder, and certificate of compliance would be added to this section. The term spent fuel storage cask would be added to the existing definitions for design bases and structures, systems, and components important to safety. The definition for design capacity would be revised to be consistent with the Commission's policy on use of metric units.
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S 72.10 Employee protection, and S 72.11 Completeness and accuracy of information.
l The terms certificate holaer and applicants for a CoC would be added.
l Subpart D - Records, Reports, inspections, and Enforceme6t S 72.86 Criminal penalties.
Paragraph (b) currently includes those sections under which criminal sanctions are not issued. This paragraph would be revised to delete reference to S 72.236, because this section is being reissued as being subject to the criminal penalty provisoin of S 223 of the Atomic X Energy Act. Similarly, certificate holders and applicants who fail to comply with the new $
1 72.242 would also be subject to criminal penalties. Therefore, S 72.242 will not be included in i
S 72.86(b).
Subpart G - Quality Assurance SS 72.140 through 72.176 g age ce % g kuc W The ter " certificate holde nd* applicants for a CoC" would be added, as appropriate, to these sections to explicitly define responsibilities associated with quality assurance requirements. In 1990, when the Commission added Subparts K and L to Part 72 to provide a process for approving the design of a spent fuel storage cask, which would be used under a general license, the Commission's intent was that certificate holders and applicants for a CoC fo!!ow the quality assurance regulations of Part 72. Section 72.234(b) required that activities relating to the design, fabrication, testing, and maintenance of spent fuel storage casks must be conducted under a quality assurance program that meets the requirements of 8
l In paragraph (d) the term " applicant" would be replaced with " certificate holder and applicant for a CoC." Contractors and subcontractors would not be added to Paragraph (d) because the !
Commission holds the certificate holder or applicant for a CoC responsible for meeting this l requirement. ,43 se tt as te % e 6 Lc;ca h m ad ks hn3
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' of s uch casks.
Paragraph (a) would be revised to permit the inspection of premisey nd activities %
related to the design of a s Some-certificate holders c.arunake-changes. '
%is c.Wqe is mde & pent fuelstorage casGte sqke o.f cy cicyess. .
tMhe design of the casit, eftc-cNftCvovaHs4ssuedrif thedanges-meetertain-conditionsr . -
TheWRC requires-eccess-to thegemisesn(SPIsrtificate holders-and their coniiavivts and-esttbcontractorMoinspect ony-such changes _to.ensurelhatpnor;NRG-approval of the-design
-change warliotIequirert:
New paragraph (b) would include a requirement to permit the inspection of records related to design, fabrication, and testing of spent fuel storage casks. This requirement is intended to make clear the responsibility of certificate holders, applicants for a CoC, and their contractors and subcontractors to permit access these recordsirether-therund+cating4 hat 4he-Coninii3sion.has hadpoblemsJn 4he-pasHn obtaining &cce5. iu suctrrecordsAn-eddittch this s%dhr requirement is comparable to the existing inspection and testing regulations in 10 CFR Parts 30,40,50, and 70.
@ 72.234 Conditions of approval.
This section would be revised to clarify who is responsible for accomplishing these i requirements. The term " cask vendor" would be replaced with " certificate holder." The term l
" cask user" would be replaced with "a general licensee using a cask." The term " general licensee" has been used because a site-specific licensee cannot utilize the provisions of 10 l
- - l Subparts K and L. In addition, the acronym "CoC"is used in place of the term " Certificate of Compliance" where appropriate.
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.6 72.236 Specific requirements for spent fuel storage cask approval.
This section would be revised to clarify who is responsible for accomplishing these i
requirements. A new sentence has been added at the beginning of this section which indicates i- !
who has responsibility for ensuring that each of the requirements contained in paragraphs (a) j
- through (m) are met. This section also would be reissued as being subject to the criminal penalty provisions of 6 223 of the Atomic Energy Act. Applicant or a CoC would not be f required to ensure that the requirements of paragraphs (j) and (k) were met because these requirements apply to activities which can only occur after a cask has been fabricated; and an i
applicant cannot begin fabrication of a cask until a CoC has been issued and an applicant has L become a certificate holder (see 6 72.234(c)).
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- $ 72.240 Conditions for spent fuel storage cask reapproval.
The terms " user of a cask" would be replaced by "a general licensee using a cask" and the term " cask model" would be replaced by " design of a spent fuel storage cask." The term l ~
" representative of a cask user" would be replaced with " the representative of a general licensee using a cask." In addition, the acronym "CoC"is used in place of the term " Certificate of Compliance"where appropriate.
9 72.242 Recordkeeping and Reports.
This new section identifies additional recordkeeping responsibilities for certificate holders and applicants for a CoC and reporting requirements for certificate holders. This 1
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1 section is intended to provide for any other recordkeeping responsibilities whic covered by the regulations in S 72.234(d). This would include records required to be kept by a condition of the CoC or records relating to design changes, nonconformances, quality l
assurance audits, and corrective actions. Violations of this section would be subje'ct to the '
criminal penalty provisions of $ 223 of the Atomic Energy Act. Paragraphs (a), (b) and (c) are similar to the recordkeeping requirements imposed on licensees in @ 72.80(a), (c), and (d).
A new requirement would be established in paragraph (d) for certificate holders to submit written reports to the NRC when they identify design or fabrication deficiencies, in stru::tures, systems, and components which are important to safety, for casks which have been delivered to licensees. This requirement is intended to inform the NRC of deficiencies which may affect existing casks and thereby potentially affect public health and safety. This requirement is similar to the event reporting requirement imposed on licensees in S 72.75(c)(2).
Criminal Penalties For the purposes of Section 223 of the Atomic Energy Act (AEA), the Commission is issuing the proposed rule to amend 10 CFR 72: 72.10, 72.11, 72.140 through 72.176, 72.232, 72.234,72.236, and 72.242, under one or more of sections 161b,1611, or 161o of the AEA.
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Willful violations of the rule would be subject to criminal enforcement.
Compatibility of Agreement State Regulations Under the " Policy Statement on Adequacy and Compatibility of Agreement State Programs" approved by the Commission on June 30,1997 and published in the Federal Register September 3,1997 (62 FR 46517), this rule is classified as compatibility Category 12
holders and applicants for a CoC, in addition to those already required by S 72.234(d). This new section would be similar to the requirements imposed on licensee's in e$ 72.75 and 72.80. l Alternatives ~
This regulatory analysis considered three attematives:
& l Altemative 1: Revise Part 72 to expand the applicability of certain provisions to certificate holders, applicants for a CoC, and their contractors and subcontractors.
i The Commission believes that problems in the areas of quality assurance, quality control, fabrication control and design control exist, are significant, and in part rgplack-of
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sierittendenderstanding by cedificate hotdersrand applicants fora CoC of-their-obligations to-
' eomply-wittrPari 72 n::quirements.--Asmuence,-ths4cmmissionbelieves4 hat-this facie l
-ofolarity within thn_rggu{ationS h8 Gimp 8cted thesefetyand qualityof the performance of spent, f efuetstorage-casks-during-design,-fabrication,-snd-testmg in the past, the Commission has
! been unable to take enforcement action against these persons when they did not comply with the regulations, because they have not been bject to the requirements of Part 72.
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Alternative 1 would allow the NRC to take enforcement actions against these persons,
- as necessary, by allowing the issuance of a NOV when they fail to comply with the i
requirements of Part 72. Presently the NRC issues a NON in these instances. V[hile it may appear that a NON and a NOV are similar, the Commission believes that the issuance of a I
l NOV is preferred because: (1) the issuance of an NOV effectively conveys to both the person violating the requirement and the public that a violation of a legally binding requirement has j occurred; (2) the use of graduated severity levels associated with a NOV allows the NRC to
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effectively convey to both the person violating the requirement and the public a clearer perspective on the safety and regulatory significance of the violation; and (3) violation of a 19 itLu. %Q ca 4L W JqyyceC,o~dCkhc G h %
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y as cu ws mu s y~ gw w
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. 1 l regulation reflects the NRC conclusion that potential risk to public health and safety could exist.
1 This evidence can then be used to support the issuance of further enforcement sanctions such l
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u as orders. l
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7 The Commission believes that this alternative will enable the NRC to make more hc? k,9.\
effective use of the Enforcement Policy against the designers, fabricators, and testers of spent fuel storage casks and that this will lead to an overall improvement in the safety and quality of spent fuel storage casks.
Alternative 2: Revise Part 72 to expand applicability of certain provisions to certificate holders and applicants for a CoC.
The difference between alternatives 1 and 2 is that the latter does not include contractors and subcontractors in clarifying the responsibilities for compliance with Part 72.
9 However, the C3iii1Tssion believes that the need to be able take enforcement action to the
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level of contractors and subcontractors is important because these persons actually accomplish the manufacturing and testing of spent fuel storage casks. These contractors and '
y subcontractors have typically established quality assurance programs as a consequence of ,Mh their contracts with the certificate holder. htternative 2 would not impose'the obHgation to- Ek Q_ ._
- A 4mplementthese requirements by regulation rather than contract on contractors and
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.subcontracters Therefore, the NRC would not be able to take enforcement action's against these persons under this alternative, but would be forced to continue to use administrative actions. The NRC believes that by taking enforcement actions against these people it will be able to enhance the protection of public health and safety. Consequently, alternative 2 was rejected.
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Altemative 3: No action.
This attemative was rejected, even though staff resources for rulemaking would have been conserved. Under this attemative it is expected that the difficulties the NRC has experienced in the past will continue. ~
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I f moacts on Licensees. Certificate Holders. Contractors and Subcontractors. NRC. and the
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f There is no difference in the impacts between Altematives 1 and 2 on these persons,
- except for contractors and subcontractors. Altemative 1 would impose new regulatory responsibilities on these categories of persons.
Imoact on Licensees No licensees would be affected by these changes to Part 72.
Imoact on Certificate Holders
{ All of the current certificate holders and applicants for a CcC would be affected by these
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changes to Part 7'2. Presently there are less than 20 such entities.
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[rnpact on Contractors and Subcontractors
. e The NRC has estimated that each certificate holder or applicant for a CoC, on average,.
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has three contractors and subcontractors. Consequently, the NRC estimates a total of 60 9 0"(2 contractors and subcontractors would be affected by these changes to Part 72 described in W
,d i Alternative 1. Because certificate holders, applicants for a CoC, and their contractors and subcontractors for the most part have already been meeting the requirements of Part 72, as 21 l
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either a condition of a certificate of compliance or as a condition of a contract between a certificate holder and their contractors and subcontractors, the burdens imposed by this alternative are not significantly increased. Alternative 2 would not impose these impacts.
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(/Imoact on the NRC
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- in most instances, the impact on the NRC is small because there is no significant i
difference in expenditure of staff resources associated with the issuance of a NOV versus a
, NON. However, in the case of escalated enforcement actions the burden on the NRC can i
increase significantly. Escalated enforcement actions are expected to occur infrequently.
Imoact on the Public I
The impact of this rulemaking is to enable the NRC to provide a clearer perception of
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the safety and regulatory significance of the issues associated with a violation and an'y potential risks to the public.
Decision Rationale For Preferred Alternatiy.g Altemative 1 is the preferred choice. The major benefit of this alternative is to allow the
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NRC to take more effective enforcement actions against certificate holders, applicants for a CoC, and their contractors and subcontractors under the current NRC Enforcement Policy.
This would enable both the person violating the regulation and the public to clearly perceive the regulatory and safety signifi' .nce and consequences of the violation.
Because certificate holders, applicants for a CoC, and their contractors and subcontractors for the most part already have been meeting the requirements of Part 72, as either a condition of a certificate of compliance or as a condition of a contract between a 22
_ . . _ - . _ _ _.. _ . . _ .._ .. . _ ._ . _ ~_ . . _ _ . _ - . . _. ___-_ _ _ . _
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certificate holder and their contractors and subcontractors, the burdens imposed by this
-amendment are not significantly increased. The new section added by this amendment
( 72.242) will add new burdens for recordkeeping and reporting requirements. The staff estimates this burden associated with the new a 72.242 to be 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> annually. Tflerefore, the Commission believes that tnis burden is insignificant by comparison with Part 72's overall burden which is in excess of 21,000 hours0 days <br />0 hours <br />0 weeks <br />0 months <br />.
l Regulatory Flexibility Certification ,
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In accordance with the Regulatory Flexibility Act of 1980, 5 U.S.C. 605(b), the
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' Commission certifies that this proposed rule would not have a significant economic impact on a substantial number of small entities; The proposed rule would amend the regulations to expand the applicability of 10 CFR Part 72 to holders of, and applicants for, Certificates of Compliance (CoC) and their contractors and subcontractors. This requirement would' enhance the Commission's ability to take enforcement action in the form of Notices of Violation rather
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than administrative action in the form of Notices of Nonconformance when legally binding requirements are violated. The proposed rule may appear to impose new requirements on a
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significant number of small entities (i.e., the contractors and subcontractors associated with certificate holders and applicants for a CoC). These requirements would involve actions such as compliance with quality assurance program requirements in Subpart G of Part 72. However,
' E r tu ctuosk " N these entitieskre already imple(menting the actions required by Subpart G as a condition of their contracts'with the certificate holder or applicant for a CoC. Therefore, the NRC believes that this amendment will not have a significant economic impau on these small entities.
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- 8. Section 72.140 is revised to read as follows:
9 72.140 Quality assurance requirements.
(a) Purpose. This Subpart describes quality assurance requirements that a'pply to design, purchase, fabrication, handling, shipping, storing, cleaning, assembly, inspection, testing, operation, maintenance, repair, modification of structures, systems, and components, I and decommissioning that are important to safety. As used in this Subpart, " quality assurance" comprises all those planned and systematic actions necessary to provide adequate confidence that a structure, system, or component will perform satisfactorily in service. Quality assurance includes quality control, which comprises those quality assurance actions related to control of the physical characteristics and quality of the material or component to predetermined requirements. The certificate holder, applicant for a CoC, and their contractors and 1
subcontractors are responsible for the quality assurance requirements as they apply to the '
design, fabrication, and testing of a spent fuel storage cask until possession of the spent fuel ;
77cwl he cerhScah, Ldec ^rc. a I
storage cask is transferred to the licensee. The licensec3Halso simultaneously responsible for e
these quality assurance requirements via the oversight of contractors and subcontractors. l l
(b) Establishment of program. Each licensee, applicrsnt for a license, certificate holder, l applicant for a CoC, and their contractors and subcontractors shall establish, maintain, and execute a quality assurance program satisfying each of the applicable criteria of this Subpart, and satisfying any specific provisions which are applicable to the licensee's, applicant's for a license, certificate holder's, applicant's for a CoC, and their contractor's and subcontractor's activities. The licensee, applicant for a license, certificate holder, applicant for a CoC, and their contractors and subcontractors shall execute the applicable criteria in a graded approach to an extent that is commensurate with the importance to safety. The quality assurance program 31
must cover the e: tivities identified in this Subpart throughout the life of the activity. For licensees, 'nis includes activities from the site selection arough decommissioning rior to termination of the license. For certificate holders this includes activities from development of the spent fuel storage cask design through termination of the CoC. '
(c) Approval of program:
(1) The licensee shall obtain Commission approval ofits quality assurance program prior e
to receipt of spent fuel at the ISFSI or spent fuel and high-level radioactive waste at the MRS.
(2) The certificate holder shall obtain Commission approval of its quality assurance program prior to commencing fabrication or testing of a spent fuel storage cask.
(3) Each licensee or certificate holder shall file a description of its quality assurance program, including a discussion of which requirements of this Suboart are applicable and how they will be satisfied, in accordance with 6 72.4.
(d) Previously approved progrems. A Commission. approved quality assurance program which satisfies the applicable criteria of Appendix B to part 50 of this chapter and which is established, maintained, and c.,cuted with regard to an ISFSI will be accepted as satisfying the requirements of paragraph (b) of this section. Prior to initial use, the licensee shall notify the Director Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 2055, of its intent to apply its previously approved Eppendix B program to ISFS! activities. The licensee shallidentify the program by date of submittal to the Commission, docket number, and date of Commission approval.
- 9. Section 72.142 is revised to read as follows:
$ 72.142 Quality assurance organization.
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l The licensee, applicant for a license, certificate holder, applicant for a CoC, and their contractors and subcontractors shall establish measures to assure that applicable regulatory requirements, design bases, and other requirements which are necessary to assure adequate quality are included or referenced in the documents for procurement of material, e'q uipment, and services. To the extent necessary, the licensee, applicant for a license, certificate holder,
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applicant for a CoC,hd their contract $s'and subcontractors hall require contractors or subcontractors to provide a quality assurance program consistent with the applicable provisions of this Subpart.
- 13. Section 72.150 is revised to read as follows:
$ 72.150 instructions, procedures, and drawings.
The licensee, applicant for a license, certificate holder, applicant for a CoC, and their contractors and subcontractors shall prescribe activities affecting quality by documented instructions, procedures, or drawings of a type appropriate to the circumstances and shall require that these instructions, procedures, and drawings be followed. The instructions, procedures, and drawings must include appropriate quantitative or qualitative acceptance criteria for determining that important activities have been satisfactorily accomplished.
- 14. Section 72.152 is revised to read as follows:
$ 72.152 Document control.
The licensee, applicant for a license, certificate holder, applicant for a CoC, and their contractors and subcontractors shall establish measures to control the issuance of documents 38
. - - - - . - . . = . - - .- .- - - - .-.-. .- - -..~.. -. -...._... .. .- .- . . -.
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- 27. Section 72.232 is revised to read as follows:
$ 72.232 inspection and tests.
(a) The certificate holder, applicant for a CoC, and their contractors and subcontractors shall permit, and make provisions fo e Commission to inspec)the premises and facilities at l
- which a spent fuel storage cask is designed, fabricated, and tested.
(b) The certificate holder, applicant for a CoC, and their contractors and subcontractors shal(hmke, avog\ ele. to Ne (emas,% & in3pch% upm reaso.wtele noke,
=a, laWha of record pertaining to the design, fabrication, and testing of spent fuel !
i storage casks. b ^9 # I "
i (c) The certificate holder, applicant for a CoC, and their contractors and subcontractors shall perform, and make provisions that permit the Commission to perform, tests that the 1
1 Commission deems necessary or appropriate for the administration of the regulations in this part.
(d) The certificate holder and applicant for a CoC shall submit a notification under $ 72.4 at least 45 days prior to starting fabrication of the first spent fuel storage cask under a Certificate of Compliance.
- 28. Section 72.234 is revised to read as follows:
$ 72.234 Conditions of approval.
(a) The certificate holder and applicant for a CoC shall ensure that the design, fabrication, testing, and maintenance of a spent fuel storage cask comply with the requirements in $ 72.236.
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(b) The certificate holder and applicant for a CoC shall. ensure that the design, 0
fabrication, testing, and maintenance of spent fuel storage casks be conducted under a quality assurance program that meets the requirements of subpart G of this part.
(c) The certificate holder and applicant for a CoC shall ensure that the fabrication of j
casks under a CoC does not begin prior to receipt of the CoC for the spent fuel storage cask. I (d)(1) The certificate holder shall ensure that a record is established and maintained for each cask fabricated under the CoC.
(2) This record must include:
(i) The NRC CoC number; (ii) The cask model number, (iii) The cask identification number, (iv) Date fabrication was started; (v) Date fabrication was completed; (vi) Certification that the cask was designed, fabricated, tested, and repaired in accordance with a quality assurance program accepted by NRC; i (vii) Certification that inspections required by $ 72.236(j) were performed and found !
satisfactory; and (viii) The name and address of the generallicensee using the cask.
to (3) The certificate holder must supply the original of this record)he general licensee using the cask. A current copy of a composite record of all casks manufactured under a CoC, showing the information in paragraph (d)(2) of this section must be initiated and maintained by the certificate holder for each model cask. If the certificate holder permanently ceases production of casks under a CoC, the certificate holder must send this composite record to the
- Commission using instructions in S 72.4.
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. , l (b) Records that are required by the regulations in this part or by conditions of the CoC shall be maintained for the period specified by the appropriate regulation or the CoC conditions.
If a retention period is not specified, the records shall be maintained until the Commission terminates the CoC. .
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(c) Any record that shall be maintained under this part may be either the original or a reproduced copy by any state of the art method provided that any reproduced copy is duly authenticated by authorized personnel and is capable of producing a clear and legible copy after storage for the period specified by Commission regulations.
(d) Each certificate holder shall submit a written report to the NRC within 30 days of discovery of a design or fabrication deficiency, for any spent fuel storage cask which has been cc delivered to a licensee, when the designgTfabrication deficiency affects the ability of structures,
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systems, and components important to safety to perform their function. The written report shall
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be sent to the NRC in accordance with the requirements of 9 72.4. The report must include the following:
(1) A brief abstract describing the deficiency, including all component or system failures that contributed to the deficiency and corrective action taken or planned to prevent recurrenca; (2) A clear, specific, narrative description of what occurred so that knowledgeable
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readers familiar with the design of the spent fuel storage cask, but not familiar with the details of a particular cask, can understand the deficiency. The narrative description must include the following specific information as appropriate for the particular event:
(i) Dates and approximate times of discovery; (ii) The cause of each component or system failure, if known; (iii) The failure mode, mechanism, and effect of each failed component, if known; I
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