Expand Applicability of Part 72 to Holders of, and Applicants for, Certificates of Compliance

SUMMARY: The Nuclear Regulatory Commission (NRC) is amending its

regulations to clarify the obligations of holders of, and applicants

for, Certificates of Compliance (CoCs). These amendments will enhance

the Commission's ability to take enforcement action against these

persons when legally binding requirements are violated. This action

will emphasize the safety and regulatory significance associated with

violations of the regulations. In addition, a new section identifies

recordkeeping and reporting requirements for certificate holders and

applicants for a CoC.

EFFECTIVE DATE: This final rule is effective on December 14, 1999.

FOR FURTHER INFORMATION CONTACT: Anthony DiPalo, telephone (301) 415-

6191, e-mail, [email protected], of the Office of Nuclear Material Safety and

Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-

0001.

SUPPLEMENTARY INFORMATION:

Background

The Commission's regulations at 10 CFR part 72 were established to

provide requirements for the issuance of licenses for the storage of

spent nuclear fuel in an independent spent fuel storage installation

(ISFSI) (45 FR 74693; November 12, 1980). In 1990, the Commission

amended part 72 to include a process for approving the design of spent

fuel storage casks and issuance of a CoC (subpart L) and for granting a

general license to reactor licensees (subpart K) to use NRC-approved

casks for storage of spent nuclear fuel (55 FR 29181; July 18, 1990).

In the past, the Commission has experienced performance problems in the

areas of design, design control, fabrication and quality control with

holders of, and applicants for, a CoC under part 72. When the NRC

identifies a failure to comply with part 72 requirements by these

persons, the enforcement sanctions available have been limited to

administrative actions.

The NRC Enforcement Policy 1 and its implementing

program was 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 used as a deterrent to

emphasize the importance of compliance with requirements and to

encourage prompt identification and comprehensive correction of the

violations. Enforcement sanctions consist of Notices of Violation

(NOVs), civil penalties, and orders of various types. In addition to

formal enforcement actions, the NRC also uses related administrative

actions such as Notices of Nonconformance (NONs), Confirmatory Action

Letters, and Demands for Information to supplement its enforcement

program. The NRC expects licensees, certificate holders, and applicants

for a CoC to adhere to any obligations and commitments that result from

these actions and will not hesitate to issue appropriate orders to

ensure that these obligations and commitments are met. The nature and

extent of the enforcement action are intended to reflect the

seriousness of the violation involved. An NOV is a written notice

setting forth one or more violations of a legally binding requirement.

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\1\ NUREG-1600, Revision 1, ``General Statement of Policy and

Procedures for NRC Enforcement Actions,'' May 1998 (at 63 FR 26630;

May 13, 1998).

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The Commission published a proposed rule in the Federal Register

(63 FR 39526; July 23, 1998). The comment period ended on October 6,

1998, and four comment letters were received on the proposed rule.

Discussion

In promulgating subpart L, the NRC intended that selected part 72

provisions would apply to spent fuel storage cask certificate holders

and applicants for a CoC. For example, Sec. 72.234(b) requires that, as

a condition for approval of a CoC, ``[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 (QA) requirements in

subpart G refer only to licensees and applicants for licenses, and not

to certificate holders. Further, some subpart L regulations apply

explicitly to ``the applicant'' (e.g., Sec. 72.232) or to ``the cask

vendor'' (e.g., Sec. 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., Sec. 72.236). Although CoCs are

legally binding documents, certificate holders or applicants for a CoC

have not clearly been brought within the scope of part 72 requirements.

Because the terms ``certificate holder'' and ``applicant for a

certificate of compliance'' 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 an NON rather than an NOV.

Although an NON and an NOV appear to be similar, the Commission

prefers the issuance of an NOV 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's conclusion that potential risk to public

health and safety could exist.

Over the last 2 years, the Commission has observed repeated

problems with the performance of several certificate holders. These

problems have occurred in design, design control, fabrication and

corrective action areas. Problems in these areas are typically covered

under the QA program. In FY 1996, the NRC staff identified numerous

instances when certificate holders and their contractors and

subcontractors failed to comply with the requirements of part 72. The

Commission has concluded that use of the additional enforcement

sanctions, which are available in the NRC Enforcement Policy, is

required to address the performance problems that have occurred in the

spent fuel storage industry. Therefore, the Commission is revising part

72 to explicitly state that certificate holders and applicants for a

CoC must comply with part 72 regulations.

Summary of the Proposed Rule Amendments

The following is a summary of the amendments that were discussed in

the proposed rule (63 FR 39526; July 23, 1998). This summary does not

include changes made in the final rule in response to public comments.

A summary of the final amendments is discussed in a separate section in

this notice.

[[Page 56115]]

Subpart A--General Provisions

Section 72.2 Scope

The term spent fuel storage cask would be added to paragraph (b) of

this section. This is a conforming amendment.

Section 72.3 Definitions

The definitions for spent fuel storage 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 (SSC) important to

safety. The definition for design capacity would be revised to be

consistent with the Commission's policy on use of metric units.

Section 72.9 Information Collection Requirements: OMB Approval

This section would be revised as a conforming amendment, because of

the addition of new Sec. 72.242.

Section 72.10 Employee Protection and

Section 72.11 Completeness and Accuracy of Information

The terms certificate holder and applicants for a Commission

license or a CoC would be added for clarification.

Subpart D--Records, Reports, Inspections, and Enforcement

Section 72.86 Criminal Penalties

Paragraph (b) currently includes those sections under which

criminal sanctions are not issued. This paragraph has been revised to

delete the reference to Sec. 72.236. This section is being revised to

provide that failure to comply with the specific requirements for spent

fuel storage cask approval would be subject to the criminal penalty

provision of Sec. 223 of the Atomic Energy Act. Similarly, certificate

holders and applicants who fail to comply with the new Sec. 72.242

(Recordkeeping and reports) would also be subject to criminal

penalties. Therefore, Sec. 72.242 will not be included in

Sec. 72.86(b).

Subpart G--Quality Assurance

Sections 72.140 Through 72.176

In the proposed rule, the term ``certificate holder and applicants

for a CoC and their contractors and subcontractors'' is added, as

appropriate, to these sections to define explicitly those

responsibilities associated with QA 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 follow the QA 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 QA program that meets the requirements of subpart

G of part 72. However, the 1990 amendments to part 72 did not amend

subpart G to include certificate holders and applicants for a CoC. In

addition, other changes have been made to individual sections of

subpart G as described below.

In Sec. 72.140, paragraphs (a) and (b) have been revised to clarify

the responsibilities of a certificate holder and a licensee with

respect to who is responsible for ensuring that the QA program is

properly implemented. Paragraph (c) has been revised to provide

milestones for a licensee and a certificate holder when the NRC must

approve their QA program. Paragraph (d) has been revised to permit use

of an NRC-approved QA program that satisfies the requirements of

subpart H to part 71 and subpart G of part 72, as well as an approved

program under Appendix B to part 50. The notification requirement in

paragraph (d) would be revised to require that the NRC be notified in

accordance with the standard notification requirements contained in

Sec. 72.4.

To provide clarity, Sec. 72.142 has been rearranged. The new

paragraph (a) has been revised to indicate that all of the persons

associated with QA activities for an ISFSI or a spent fuel storage cask

(i.e., the licensee, certificate holder, and applicants for a CoC or

license, and in the proposed rule their contractors and subcontractors)

are responsible for implementation of the QA program.

In Sec. 72.144 paragraphs (a) and (b), Sec. 72.154 paragraph (b),

Sec. 72.162, and Sec. 72.168 paragraph (a), the term spent fuel storage

cask has been added to the terms ISFSI and MRS.

Subpart L--Approval of Spent Fuel Storage Casks

Section 72.232 Inspection and Tests

This section has been reformatted by adding a new paragraph (b) and

renumbering existing paragraphs (b) and (c). In paragraphs (a), (b),

and (c), the term ``applicant'' has been replaced with ``certificate

holder and applicant for a CoC.'' In paragraph (d), the term

``applicant'' would be replaced with ``certificate holder and applicant

for a CoC.''

Paragraph (a) has been revised to permit the inspection of the

premises and activities related to the design of a spent fuel storage

cask as well as to the fabrication and testing of such casks. This

change would be made to ensure completeness.

A new paragraph (b) includes a requirement to permit the inspection

of records related to design, fabrication, and testing of spent fuel

storage casks. This requirement would make clear the responsibility of

certificate holders and applicants for a CoC to permit access to these

records. This requirement is similar to the existing inspection and

testing regulations in 10 CFR Parts 30, 40, 50, and 70.

Section 72.234 Conditions of Approval

This section has been revised to clarify who is responsible for

accomplishing these requirements. The term ``cask vendor'' has been

replaced with ``certificate holder.'' The term ``cask user'' has been

replaced with ``the licensee using the spent fuel storage cask.''

Although the replacement term in the proposed rule was ``the general

licensee using the cask'' because a specific licensee cannot utilize

the provisions of subparts K and L, it is conceivable that, in the

future, a specific licensee could become a user of a certified cask.

Accordingly, the NRC prefers the broader term. A similar change is made

in Sec. 72.240 as proposed. Further, edits would be made in

Secs. 72.234 and 72.236 to clarify that all references to ``casks'' are

references to ``spent fuel storage casks.'' In addition, the acronym

``CoC'' would be used in place of the term ``Certificate of

Compliance,'' where appropriate.

Section 72.236 Specific Requirements for Spent Fuel Storage Cask

Approval

This section has been revised to clarify who is responsible for

accomplishing these requirements. A new sentence would be added at the

beginning of this section to specify who has responsibility for

ensuring that each of the requirements contained in paragraphs (a)

through (m) is met. This section has been reissued as being subject to

the criminal penalty provisions of Sec. 223 of the Atomic Energy Act.

Applicants for a CoC would not be required to ensure that the

requirements of paragraphs (j) and (k) were met because these

requirements apply to activities that can only occur after a cask has

been fabricated, and an applicant cannot begin fabrication of a cask

until a CoC has been issued (see Sec. 72.234(c)).

Section 72.240 Conditions for Spent Fuel Storage Cask Reapproval

This section has been revised to clarify who is responsible for

accomplishing these requirements. The

[[Page 56116]]

term ``user of a cask'' has been replaced with ``the licensee using the

spent fuel storage cask'' and the term ``cask model'' has been replaced

with ``design of a spent fuel storage cask.'' The term ``representative

of a cask user'' has been replaced with ``the representative of the

licensee using the spent fuel storage cask.'' In addition, the acronym

``CoC'' is used in place of the term ``Certificate of Compliance''

where appropriate.

Section 72.242 Recordkeeping and Reports

This new section identifies recordkeeping and reporting

requirements for certificate holders and applicants for a CoC that are

not already covered by the regulations in Sec. 72.234(d). This includes

records required to be kept by a condition of the CoC or records

relating to design changes, nonconformances, QA audits, and corrective

actions. Violations of this section are subject to the criminal penalty

provisions of Sec. 223 of the Atomic Energy Act of 1954. Paragraphs

(a), (b), and (c) are similar to the recordkeeping requirements imposed

on licensees in Sec. 72.80 (a), (c), and (d).

A new requirement has been established in paragraph (d) for

certificate holders to submit written reports to the NRC when they

identify design or fabrication deficiencies, in structures, systems,

and components that are important to safety for spent fuel storage

casks that have been delivered to licensees. This requirement would

inform the NRC of deficiencies that may affect existing casks and

thereby potentially affect public health and safety. This requirement

would be similar to the event reporting requirement imposed on

licensees in Sec. 72.75(c)(2).

Summary of Public Comments on the Proposed Rule

The NRC received four comment letters on the proposed rule. The

commenters included a member of the public, one cask fabricator, and

two part 72 certificate holders. Three of the four commenters favored

the proposed amendments, and one was opposed. Copies of the public

comments are available for review in the NRC Public Document Room, 2120

L Street, NW (Lower Level), Washington, DC 20003-1527. One commenter, a

member of the public, raised many issues unrelated to this rulemaking

(e.g., issues that are being addressed in a separate petition for

rulemaking (i.e., PRM-72-3), the NRC Enforcement Policy, the NRC

Inspection Program, and NRC oversight of the overall spent fuel storage

program). The NRC believes these issues are beyond the scope of this

rule.

A review of the comments and the Commission's responses follow:

1. Comment: One commenter, a certificate holder, recommended for

clarity that in the proposed definition of ``certificate holder'' in

Sec. 72.3, the words ``company'' or ``organization'' replace the word

``person,'' because a certificate of compliance is not issued to a

specific person.

Response: The NRC disagrees with the comment. The definition of

``person'' in the rule has the same meaning as ``person'' defined in

section 11s. of the Atomic Energy Act of 1954. This definition

encompasses a wide range of entities (i.e., individuals, corporations,

trusts, government agencies, states, and foreign governments) who may

wish to apply for a part 72 license or certificate. Therefore, no

change has been made in the final rule.

2. Comment: One commenter, a certificate holder, agreed that design

changes should have appropriate controls. However, the commenter stated

that it is not clear whether design changes undertaken by the

certificate holder require prior NRC approval. Currently, Sec. 72.48

identifies those changes that the licensee may make without prior NRC

review, and Sec. 72.70 addresses the licensee's responsibility to

update its Safety Analysis Report (SAR). But, the rule does not apply

Secs. 72.48 and 72.70 to the certificate holders. The commenter stated

that the rule did not address whether prior NRC approval is required

for a design change made by a certificate holder that would necessitate

a revision of the cask SAR, but would not specifically deviate from the

CoC; and how the SAR will be updated to reflect these changes.

The commenter recommended that the proposed revision of

Sec. 72.146(c) needs clarification of when prior NRC approval is

required for certificate holders and the means to control changes to

the SAR that do not require a change to the CoC. The commenter believed

that the most direct method to address this concern is to revise part

72 to apply Secs. 72.48 and 72.70 to certificate holders. The commenter

recognized that NRC intends to pursue changes to Sec. 72.48 in the

future. However, without changes to Secs. 72.48 and 72.70 at this time,

the commenter believes that some clarifications are necessary in order

to implement the proposed revisions to Sec. 72.146(c).

Response: The NRC agrees in part with the comment. Revising the

proposed rule to add provisions to permit a certificate holder to use

the provisions of Sec. 72.48 to make changes to the design of a spent

fuel storage cask, without prior NRC approval, is beyond the scope of

this rulemaking. However, the Commission has approved a separate final

rule on ``Changes, Tests, and Experiments'' (64 FR 53582; October 4,

1999) that addresses the issues raised by the commenter. The ``Changes,

Tests, and Experiments'' final rule revises Sec. 72.48 to permit a

certificate holder to make certain changes to the design of a spent

fuel storage cask, without NRC prior approval. The ``Changes, Tests,

and Experiments'' final rule also revises the requirements in

Sec. 72.70 on licensees in updating their SAR; and adds requirements in

a new Sec. 72.248 on certificate holders updating their SARs.

3. Comment: One commenter, a certificate holder, concurs with

proposed changes for clarification, but believes that the imposition of

enforcement actions may not be necessary. If the NRC decides that

enforcement actions are necessary, then the commenter believes that it

should not apply to the subcontractors of certificate holders, because

in the commenter's view: (1) It does not seem fair to extend

enforcement actions to organizations which do not have a direct

regulatory link to the NRC; and (2) subjecting such contractors and

subcontractors to enforcement action exposes them to business risks

which could cause them to refuse to become contractors and

subcontractors of certificate holders or cause them to increase their

prices. Another commenter believed that subjecting parties to NRC

enforcement actions that have no formal regulatory connection presents

severe business risks that have a real cost to small businesses and

could prove detrimental to a ``rather small and highly specialized

group of fabricators.''

Response: The NRC agrees with the commenters. The NRC expects that

persons involved in the manufacture of a spent fuel storage cask will

take full responsibility for their obligations to implement the

requirements of the part 72 QA regulations. The NRC has reconsidered

and now believes that the imposition of enforcement actions against

contractors and subcontractors is not necessary. Section 72.148

requires that, to the extent necessary, the licensee, certificate

holder, and applicants shall require contractors or subcontractors to

provide a QA program consistent with Part 72. Licensees, certificate

holders, and applicants are responsible for assuring that their

contractors and subcontractors are implementing adequate QA programs.

Therefore, the NRC has revised the final

[[Page 56117]]

rule to remove references to contractors and subcontractors.

4. Comment: One commenter, a certificate holder, raised a concern

with the proposed extension of enforcement actions to cover

Sec. 72.236. Several paragraphs in this section, such as (a), (i), and

(m), contain wording like ``but not limited to'' and ``to the extent

practicable'' that the commenter believes are highly subjective. The

commenter does not believe that certificate holders should be subject

to enforcement actions based on someone's opinion regarding what is

practicable.

Response: The NRC recognizes the use of wording ``but not limited

to'' and ``to the extent practicable,'' could be viewed as subjective,

when interpreting the regulations; however, the changes to paragraphs

(a), (i), and (m) did not change the substance of Sec. 72.236. This

wording is regularly used in statutes and regulations and the NRC

believes this wording will be reasonably interpreted in enforcement

actions.

5. Comment: One commenter, a member of the public, disagreed with

the proposed language in Sec. 72.140(a) stating that she ``* * * did

not like the term licensee and certificate holder being simultaneously

responsible for implementing the quality assurance (QA) requirements

for oversight of contractors and subcontractors activities.'' The

commenter was concerned that imposing dual responsibility for the same

activity was tantamount to implying that no one was responsible. The

commenter believed there needed to be a clear cut line of

responsibility to determine what the licensee is actually liable for.

Response: The NRC disagrees with the comment. The NRC intended that

both licensees and CoC holders be held accountable for oversight of

their contractor (i.e., fabricator) activities and that this redundant

responsibility would ensure that the spent fuel storage casks are

manufactured in conformance with the approved design and part 72 QA

requirements. The NRC believes that this approach will have an overall

positive effect on improving quality in the manufacture of spent fuel

storage casks.

6. Comment: One commenter, a certificate holder, agreed with the

proposed change in Sec. 72.140(c)(2) to require certificate holders to

obtain NRC approval of its quality assurance program prior to

commencing fabrication or testing of a spent fuel storage cask.

However, this commenter also noted that Sec. 72.140(d) states that a

quality assurance program which satisfies Appendix B to part 50 is

acceptable for part 72. The commenter also noted that a certificate

holder may have a quality assurance program that has been approved by

the NRC under part 71 or approved by the NRC for another part 72 CoC

application. The commenter suggested that Sec. 72.140(d) be revised to

include a quality assurance program which has been previously approved

for part 71 or part 72 as acceptable for new CoC applications under

part 72.

Response: The NRC agrees with the comment. The QA requirements

contained in 10 CFR part 50, appendix B; 10 CFR part 71, subpart H; and

10 CFR part 72, subpart G, are essentially equivalent. The proposed

rule revises Sec. 72.140(c), ``Approval of Programs,'' to expand this

paragraph to indicate that a certificate holder must have an NRC-

approved QA program before commencing fabrication or testing of a spent

fuel storage cask. The NRC agrees that the definition of an

``approved'' QA program found in Sec. 72.140(d) should include other

NRC-approved QA programs. This final rule is revised to allow for the

use of all NRC-approved QA programs as satisfying the requirements of

subpart G.

Additionally, the language in Sec. 72.140(d) is revised to reflect:

(1) The recordkeeping requirement in Sec. 72.174; and (2) the current

location for submitting information to the NRC in Sec. 72.4. These

requirements were added to Sec. 72.140(d) by a different rulemaking

(see the final rule entitled ``Miscellaneous Changes to Licensing

Requirements for the Independent Storage of Spent Fuel and High-Level

Radioactive Waste'' (64 FR 33178; June 22, 1999)). The language in

Sec. 72.140(c) and (d) is revised to be consistent with paragraph (b)

of this section to indicate that the requirements in these paragraphs

apply to a licensee, applicant for a license, certificate holder, and

applicant for a certificate, as appropriate.

7. Comment: One commenter, a member of the public, expressed

concern with the NRC's process for issuing exemptions to the

requirement in Sec. 72.234(c).

Note: Section 72.234(c) currently prohibits beginning cask

fabrication before the NRC issues a Certificate of Compliance.

Response: The NRC believes this comment is beyond the scope of this

rulemaking. While Sec. 72.234, ``Conditions for Approval,'' was revised

in this rulemaking, no change to paragraph (c) of this section was

proposed. Rather, this section was revised to clarify who is

responsible for implementing these requirements. The process for

granting an exemption to part 72 under the provisions of Sec. 72.7,

including Sec. 72.234(c), is adequate. An amendment to Sec. 72.234(c)

specifically addressing the issue of beginning cask construction before

a CoC is issued is addressed in a different rulemaking currently under

development by the NRC staff (see proposed rulemaking on

``Clarification and Addition of Flexibility to Part 72,'' RIN-AG15).

8. Comment: One commenter, a certificate holder, raised the issue

that the added requirement in Sec. 72.242(d) requires a written report

when the design or fabrication deficiency affects the ability of

structures, systems, and components (SSCs) important to safety to

perform their intended safety function. The commenter indicated that an

individual SSC may perform more than one function. Some of these may be

safety related while other functions may not serve a safety function.

As an example, a coating may assist in heat removal as a function

important to safety but may also serve as an aesthetic function. For

this example, the proposed rule could be interpreted to require a

written report addressing a deficiency associated with an aesthetic

function, even though the particular component would be capable of

performing its safety function. It would be an unwarranted use of

industry and NRC resources to report deficiencies that do not affect a

safety function. The commenter further raised the issue that the

deficiency may affect the safety function of such SSCs, but the

deficiency may not prevent such structure, system, or component from

performing its intended safety function. As an example, a deficiency in

a coating may be discovered such that the manufacturer lowers its peak

heat transfer rating. However, the cask design as stated in the Safety

Analysis Report may not rely upon such a high rating. It also would be

an unwarranted use of industry and NRC resources to report deficiencies

that do not affect the ability of the component to perform its intended

safety function. The commenter suggested revising Sec. 72.242(d) to

read as follows: ``* * *deficiency affects the ability of structures,

systems, and components important to safety to perform their intended

safety function,'' (emphasis in original).

Response: The NRC agrees with the comment and the final rule has

been revised to incorporate the comment.

9. Comment: One commenter, a cask fabricator, had two objections to

the proposed rule. First, the commenter was opposed to the potential

for issuance of NOVs and civil penalties against cask fabricators

because they have no

[[Page 56118]]

responsibilities or involvement in developing the design configurations

for the various spent fuel packages. Second, the commenter indicated

that the proposed changes to Sec. 72.146(a) and (b), ``Design

Control,'' were troublesome because, under the current procurement

process for spent fuel packages, the commenter believes fabricators are

intentionally precluded from the development of front end design and

licensing activities. The fabricator currently bases manufacturing

planning documentation upon the adequacy of a customer provided

specification package. The commenter indicated that the fabricator may

or may not utilize customer provided drawings for manufacture and that

where the fabricator generates the drawings the designer and/or

licensee might require their review and approval, but that there is no

accepted industry practice on this matter.

Response: The NRC agrees that contractors and subcontractors need

not be included within the scope of the changes made in the final rule.

See the response to comment number 3. Licensees and certificate holders

are responsible for QA requirements through their oversight of

contractors and subcontractors, and fabricators are generally

contractors or subcontractors. However, if the contract calls for the

fabricator to build according to a design provided by the certificate

holder, the NRC expects the fabricator to do just that. The NRC needs

assurance that the spent fuel storage casks are manufactured in

accordance with the NRC approved design and will hold licensees and

certificate holders and applicants responsible for meeting design and

QA requirements. Regarding the commenter's concern on the subject of

the use of civil penalties; i.e., whether a civil penalty is the

appropriate response to a violation of part 72, the NRC notes that this

rulemaking does not provide authority for issuing a civil penalty to

nonlicensees, other than under the Deliberate Misconduct Rule. The

final rule does allow the use of issuance of NOV's or Orders, rather

than administrative sanctions.

10. Comment: One commenter, a certificate holder, while agreeing

with the purpose of the proposed rulemaking, raised a concern with the

added requirement that identifies additional recordkeeping and

reporting requirements for certificate holders. The NRC estimated the

burden associated with these new requirements in the Paperwork

Reduction Act Statement provided with the Supplementary Information in

the proposed rule as 6 hours annually. The commenter notes that the

annual burden for recordkeeping and reporting proposed by the revised

part 72 would far exceed 6 hours annually. The estimate of 6 hours for

annual training would be sufficient to address the training of

personnel to implement these new requirements but would not be

sufficient to address the actual recordkeeping and reporting. Of

course, the actual burden any individual certificate holder would incur

because of the required recordkeeping and reporting would vary by

certificate holder. This commenter believes that the estimated burden

is greater than 100 hours annually but believes that the purpose of the

final rule justifies this burden.

Response: The NRC agrees with the comment. The NRC has reevaluated

the recordkeeping and reporting burden estimated for Sec. 72.242 and

concluded that the commenter's estimate of 100 hours annually is

reasonable. The NRC has verified with the Office of Management and

Budget (OMB) that burden increase is an extremely small percentage

increase of the present total 21,454-hour burden for part 72.

Summary of Final Amendments

The amended sections listed below have not changed from the

proposed rule and are included in the final rule, some editorial

changes to improve the organization and readability of the existing

language have also been made. These are: Secs. 72.2, 72.3, 72.9, 72.10,

72.86, 72.234, 72.236, 72.240, and 72.242(a), (b), and (c).

In the final rule, Secs. 72.140, 72.142, 72.144, 72.146, 72.148,

72.150, 72.152, 72.154, 72.156, 72.158, 72.160, 72.162, 72.164, 72.168,

72.170, 72.172, 72.174, 72.176, and 72.232 have been revised in

response to comments, and the terms ``contractor and subcontractor''

are removed. However, this action has not been taken in Sec. 72.10 and

Sec. 72.148, in part, because the current regulation contains those

terms.

Additionally, in Sec. 72.148, text at the end of the first sentence

in the current regulation was inadvertently omitted in the proposed

rule. It has been restored and will read as follows: ``* * * for

procurement of material, equipment, and services, whether purchased by

the licensee, certificate holder, or by their contractors and

subcontractors.'' (emphasis added)

In Sec. 72.140 of the final rule, paragraphs (c) and (d) are

revised in response to comments received on the proposed rule as

follows:

Section 72.140 (c) and (d): The QA requirements contained in 10 CFR

part 50, appendix B; 10 CFR part 71, subpart H; and 10 CFR part 72,

subpart G, are essentially equivalent. The proposed rule revised

Sec. 72.140(c), ``Approval of Programs,'' to expand this paragraph to

indicate that a certificate holder must have an NRC-approved QA program

before commencing fabrication or testing of a spent fuel storage cask.

The NRC agrees that the definition of an ``approved'' QA program found

in Sec. 72.140(d) should include all other NRC-approved QA programs.

The final rule is revised to allow for the use of all NRC-approved QA

programs as satisfying the requirements of Subpart G. Additionally, the

language in Sec. 72.140(d) is revised to reflect the recordkeeping

requirement in Sec. 72.174 and the address for submitting information

in Sec. 72.4, which were added to this section by a different

rulemaking (see Miscellaneous Changes to Licensing Requirements for the

Independent Storage of Spent Fuel and High-Level Radioactive Waste (see

64 FR 33178; June 22, 1999). The language in Sec. 72.140(c) and (d) is

revised to be consistent with paragraph (b) of this section to indicate

that the requirements in these paragraphs apply to a licensee,

applicant for a license, certificate holder, and applicant for a

certificate, as appropriate.

In the final rule, Sec. 72.242(d) is modified to accept the comment

that written reports should be made when a design or fabrication

deficiency affects the ability of SSCs important to safety to perform

their intended safety function.

Criminal Penalties

For the purposes of Section 223 of the Atomic Energy Act (AEA), the

Commission is issuing the final rule to amend 10 CFR part 72:

Sec. 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, 161i, or 161o of the AEA.

Willful violations of the rule would be subject to criminal

enforcement.

Agreement State Compatibility

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 on September 3, 1997 (62 FR

46517), this rule is classified as compatibility Category ``NRC.''

Compatibility is not required for Category ``NRC'' regulations. The NRC

program elements in this category are those that relate directly to

areas of regulation reserved to the NRC by the AEA or the provisions of

Title 10 of the Code of Federal Regulations, and although an Agreement

[[Page 56119]]

State may not adopt program elements reserved to NRC, it may wish to

inform its licensees of certain requirements via a mechanism that is

consistent with the particular State's administrative procedure laws,

but does not confer regulatory authority on the State.

Voluntary Consensus Standards

The National Technology Transfer Act of 1995 (Public Law 104-113)

requires that Federal agencies use technical standards that are

developed or adopted by voluntary consensus standards bodies unless the

use of such a standard is inconsistent with applicable law or otherwise

impractical. In this final rule, the NRC is expanding the applicability

of Part 72 to holders of, and applicants for, certificates of

compliance, and a voluntary consensus standard is not applicable.

Environmental Impact: Categorical Exclusion

The NRC has determined that this final rule is the type of action

described as a categorical exclusion in 10 CFR 51.22(c)(2) and (3).

Therefore, neither an environmental impact statement nor an

environmental assessment has been prepared for this final rule.

Paperwork Reduction Act Statement

This final rule increases the burden on licensees by expanding the

applicability of part 72 to holders of, and applicants for,

Certificates of Compliance. The public burden for this information

collection is estimated to average 100 hours annually. Because the

burden for this information collection is insignificant by comparison

with current part 72's overall burden, Office of Management and Budget

(OMB) clearance is not required. Existing requirements were approved by

the OMB approval number 3150-0132.

Public Protection Notification

If a means used to impose an information collection does not

display a currently valid OMB control number, the NRC may not conduct

or sponsor, and a person is not required to respond to, the information

collection.

Regulatory Analysis

Statement of the Problem

The Commission's regulations at 10 CFR part 72 were designed to

provide specific licensing requirements for the storage of spent

nuclear fuel in an independent spent fuel storage installation (ISFSI)

(45 FR 74693; November 12, 1980). These requirements were later amended

to include the storage of high-level waste (HLW) at a monitored

retrieval storage (MRS) installation. In 1990, the Commission amended

part 72 to include a process for approving the design of spent fuel

storage casks by issuance of a certificate of compliance (subpart L)

and for granting a general license to reactor licensees (subpart K) to

use NRC-approved casks for storage of spent nuclear fuel (55 FR 29181;

July 18, 1990). In the past, the Commission experienced performance

problems in design, design control, fabrication and quality control

with holders of, and applicants for, a CoC under part 72.

When the NRC identifies a failure to comply with part 72

requirements by these persons, the NRC has issued Notices of

Nonconformance (NONs). The issuance of an NON does not effectively

convey that a violation of a legally binding requirement has occurred.

Because the current regulations do not clearly impose requirements on

these persons, the NRC has not taken enforcement action, such as a

Notice of Violation (NOV), against certificate holders and applicants.

Some part 72 provisions for cask storage of spent fuel (e.g., the

quality assurance (QA) requirements) were intended to apply to cask

certificate holders and applicants for cask CoCs, as well as to holders

of licenses and applicants for a license to store spent nuclear fuel at

an ISFSI. However, some of the part 72 requirements intended to apply

to certificate holders and applicants do not clearly bring these

persons within the scope of the requirement. For this reason, the NRC

has not had a clear basis to cite certificate holders and applicants

for a CoC for violations of those part 72 requirements.

Additionally, broader requirements for recordkeeping and reporting

for certificate holders and applicants for a CoC to include records

required to be kept by a condition of the CoC, are needed. Therefore,

the NRC is adding Sec. 72.242. This will provide an enforcement basis

equivalence to the recordkeeping and reporting regulations for

licensees (Sec. 72.80).

Purpose of the Rulemaking

The purpose of this rulemaking is to expand the applicability of

part 72 to holders of, and applicants for, CoCs. This would allow the

NRC staff to take enforcement action in the form of NOVs or orders,

rather than administrative action in the form of an NON when

requirements are violated. While it may appear that an NON and an NOV

are similar, the NRC 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's

conclusion that potential risk to public health and safety could exist.

Current Regulatory Framework and Proposed Changes

In promulgating subpart L, the NRC intended that selected part 72

provisions would apply to cask certificate holders and applicants for a

CoC. For example, Sec. 72.234(b) requires that, as a condition for

approval of a CoC, ``[d]esign, fabrication, testing, and maintenance of

spent fuel storage casks be conducted under a QA program that meets the

requirements of subpart G of this part.'' However, the QA requirements

in subpart G refer only to licensees and applicants for licenses and

not to certificate holders. Some of the subpart L regulations apply

explicitly only to ``the applicant'' (e.g., Sec. 72.232), or to ``the

cask vendor'' (e.g., Sec. 72.234(d)(1)). Some are written in the

passive voice so that it is not clear who is responsible for meeting

the requirement (e.g., Sec. 72.236). Because of these regulatory

deficiencies, certificate holders or applicants for a CoC have not

clearly been brought within the scope of part 72 requirements, and the

NRC has not had a clear basis to cite these persons for violations of

part 72 requirements. Presently, when the NRC has identified a failure

to comply with part 72 requirements by these persons, it has issued an

administrative action under the NRC's Enforcement Policy.

The NRC Enforcement Policy and 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 as a deterrent to:

(1) Emphasize the importance of compliance with requirements; and (2)

encourage prompt identification and comprehensive correction of the

violations. Enforcement sanctions consist of NOVs, civil penalties, and

orders of various types. In addition to the formal enforcement actions,

the NRC also uses related administrative actions such as NONs,

Confirmatory Action Letters, and Demands for Information to supplement

the NRC's enforcement program. The NRC expects licensees and holders

of, and applicants for, a CoC to adhere to

[[Page 56120]]

any obligations and commitments resulting from these actions and will

not hesitate to issue appropriate orders to ensure that these

obligations and commitments are met. The nature and extent of the

enforcement action is intended to reflect the seriousness of the

violation involved.

This rule revises the regulations in part 72 to place explicit

requirements on certificate holders and applicants for a CoC.

Additionally, terms contained in Subpart L, such as cask user,

representative of a cask user, cask model, and cask vendor, have been

clarified. Changes are made to Sec. 72.10, ``Employee Protection,'' and

Sec. 72.11, ``Completeness and Accuracy of Information,'' to include

certificate holders and applicants for a CoC. Section 72.3 is revised

to: (1) Incorporate definitions for ``certificate holder,''

``certificate of compliance,'' and ``spent fuel storage cask''; (2)

amend the definitions for ``design bases'' and ``structures, systems,

and components important to safety'' to include the term ``spent fuel

storage cask''; and (3) amend the definition for ``design capacity'' to

be consistent with the NRC's policy on the use of metric units. Section

72.236 is revised and reissued as being subject to the criminal penalty

provisions of Sec. 223 of the Atomic Energy Act of 1954, and

Sec. 72.86(b), ``Criminal Penalties,'' is revised to delete mention of

Sec. 72.236 as a conforming change. Section 72.232 is reformatted by

adding a new paragraph (b) and renumbering existing paragraphs (b) and

(c). The term ``applicant'' is replaced by the term ``certificate

holder and applicant for a CoC.'' Requirements to permit inspection of

records, premises, and activities related to the design, fabrication,

and testing of spent fuel storage casks have been clarified. Lastly, a

new Sec. 72.242 is added to subpart L to address additional

recordkeeping and reporting requirements for certificate holders and

applicants for a CoC, in addition to those already required by

Sec. 72.234(d). This new section is similar to the requirements imposed

on licensees in Sec. 72.80.

Alternatives

This regulatory analysis considered three alternatives:

Alternative 1: Revise part 72 to expand the applicability of certain

provisions to certificate holders, applicants for a CoC, and their

contractors and subcontractors.

The NRC believes that problems in the areas of quality assurance,

quality control, fabrication control, and design control exist, are

significant, and, in part, reflect the fact that certificate holders

and applicants, and their contractors and subcontractors, have not been

explicitly included in certain part 72 requirements despite the NRC's

intent that these persons follow these requirements. Contractors and

subcontractors actually accomplish the manufacturing and testing of

spent fuel storage casks.

Alternative 1 would allow the NRC to issue NOV's or orders against

these persons, as necessary, by allowing the issuance of an NOV when

they fail to comply with the requirements of part 72. Presently the NRC

issues an NON in these instances.

The NRC has estimated that each certificate holder or applicant for

a CoC, on average, has three contractors and subcontractors.

Consequently, the NRC estimates that a total of 60 contractors and

subcontractors would be affected by changes to part 72 described in

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 either a condition of a CoC

or as a condition of a contract between a certificate holder and its

contractors and subcontractors, the burdens imposed by this alternative

are not significantly increased.

The NRC believes that Alternative 1 would have enabled the NRC to

make more effective use of the Enforcement Policy against the

certificate holders, and their contractors and subcontractors of spent

fuel storage casks. However, holding contractors and subcontractors

responsible as contemplated by the proposed rule would dilute the

message that the Commission's regulations would otherwise make clear--

that licensees and certificate holders are ultimately responsible for

assuring quality. Furthermore, the current regulations in Sec. 72.148

make clear that ``[t]o the extent necessary, the licensee shall require

contractors or subcontractors to provide a quality assurance program

consistent with the applicable provisions of this subpart [Subpart

G].''

Alternative 2: Revise part 72 to expand the 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. Therefore, the NRC would

not issue NOVs or orders against these persons under this alternative

but would continue to use administrative actions. Several comments were

received that were opposed to adding contractors and subcontractors to

the regulations. Overall, the commenters felt this action was

unnecessary and an excessive burden on small entities. The proposed

rule to extend NRC's regulatory requirements under part 72, subpart G,

to contractors and subcontractors would be inconsistent with the way in

which the NRC regulates quality assurance in other arenas, including

reactor parts and equipment. In both instances, there is a potential

that deficiencies in the quality assurance program could lead to safety

related problems. However, NRC's longstanding regulatory approach has

been to make it clear that licensees are responsible for ensuring that

the parts and equipment are safe.

Therefore, the NRC has reconsidered and concluded that contractors

and subcontractors should not be included in these regulations.

Consequently, Alternative 2 is adopted.

Alternative 3: No action.

This alternative was rejected, even though staff resources for

rulemaking would have been conserved. Under this alternative, it is

expected that the difficulties the NRC has observed in the past will

continue.

Decision Rationale for Preferred Alternative

Alternative 2 is the preferred choice. The major benefit of this

alternative is to allow the NRC to issue NOVs or Orders against

certificate holders and applicants for a CoC under the current NRC

Enforcement Policy, without imposing an unnecessary burden on

contractors and subcontractors; and ensures that quality assurance

requirements imposed on contractors and subcontractors are consistent

for both reactor and material activities. This would enable both the

person violating the regulation and the public to clearly perceive the

regulatory and safety significance and consequences of the violation.

Because certificate holders and applicants for a CoC, for the most

part, already have been meeting the requirements of part 72 as a

condition of a CoC, the burdens imposed by this amendment are not

significantly increased. Additional requirements for recordkeeping and

reporting for certificate holders are needed, to include records

required to be kept by a condition of the CoC. This will provide an

enforcement basis equivalence to the recordkeeping and reporting

regulations for licensees (Sec. 72.80). Therefore, the NRC is adding

Sec. 72.242. The new Sec. 72.242 will add

[[Page 56121]]

new burdens for recordkeeping and reporting requirements. The staff

estimates this burden associated with the new Sec. 72.242 to be

approximately 100 hours annually. This recordkeeping and reporting

burden will vary by certificate holders. The NRC believes that the

purpose of the final rule justifies this burden on certificate holders.

This burden is insignificant by comparison with part 72's overall

burden which is in excess of 21,000 hours. In addition, the current

backfit regulation in Sec. 72.62 applies only to part 72 licensees and

not to holders of, and applicants for, a CoC. This rule adds

recordkeeping and reporting requirements for holders of, and applicants

for, CoCs. Therefore, a backfit analysis is not required for this rule.

Regulatory Flexibility Certification

In accordance with the Regulatory Flexibility Act of 1980, 5 U.S.C.

605(b), the Commission certifies that this final rule will not have a

significant economic impact on a substantial number of small entities.

The final rule amends the regulations to expand the applicability of 10

CFR part 72 to holders of, and applicants for, CoCs. This requirement

will enhance the Commission's ability to take enforcement action by

issuing NOVs or orders rather than administrative action in the form of

NONs when legally binding requirements are violated. The final rule may

appear to impose new requirements on some small entities on the

assumption that could be a certificate holder or applicant able to

qualify as a ``small entity''. However, these entities, for the most

part, are already implementing the actions required by the final rule.

Therefore, the NRC believes that this amendment will not have a

significant economic impact on any such small entity.

Small Business Regulatory Enforcement Fairness Act

In accordance with the Small Business Regulatory Enforcement

Fairness Act of 1996, the NRC has determined that this action is not

``a major'' rule and has verified this determination with the Office of

Information and Regulatory Affairs, Office of Management and Budget.

Backfit Analysis

The current backfit regulation in Sec. 72.62 applies only to part

72 licensees and not to holders of, and applicants for, a CoC. This

rule, in any event, adds only reporting and recordkeeping requirements

for holders of, and applicants for, CoCs. The Commission has determined

that reporting and recordkeeping requirements are not considered

backfits even though they may result in changes to procedures. If the

reporting or recordkeeping requirements had to meet the standards for a

backfit analysis, the Commission would have to find that the

information would substantially increase public health or safety or

common defense and security without knowing the results of the request.

In addition, the existence or non-existence of a record or report

usually has no independent safety significance as compared to actions

taken by the licensee, certificate holder, or NRC as a result of the

information contained in the record or report. It is this resulting

action that affects public health and safety or the common defense or

security that should be measured under the backfit standard and not the

method for obtaining or maintaining the information.

However, the NRC has prepared a regulatory analysis which sets

forth the objectives of the rulemaking changes, the alternatives that

were considered, and the expected costs and benefits associated with

the rulemaking changes. The NRC regards this analysis as providing for

a disciplined approach for evaluating the impacts of the proposed

changes, which satisfies the underlying purposes of the backfitting

requirements in Sec. 72.62.

List of Subjects in 10 CFR Part 72

Criminal penalties, Manpower training programs, Nuclear materials,

Occupational safety and health, Reporting and recordkeeping

requirements, Security measures, Spent fuel.

For the reasons set out in the preamble and under the authority of

the Atomic Energy Act of 1954, as amended; the Energy Reorganization

Act of 1974, as amended; and 5 U.S.C. 552 and 553, the NRC is adopting

the following amendments to 10 CFR part 72.

PART 72--LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF

SPENT NUCLEAR FUEL AND HIGH-LEVEL RADIOACTIVE WASTE

1. The authority citation for part 72 is revised to read as

follows:

Authority: Secs. 51, 53, 57, 62, 63, 65, 69, 81, 161, 182, 183,

184, 186, 187, 189, 68 Stat. 929, 930, 932, 933, 934, 935, 948, 953,

954, 955, as amended; sec. 234, 83 Stat. 444, as amended (42 U.S.C.

2071, 2073, 2077, 2092, 2093, 2095, 2099, 2111, 2201, 2232, 2233,

2234, 2236, 2237, 2238, 2282); sec. 274, Pub. L. 86-373, 73 Stat.

688, as amended (42 U.S.C. 2021); sec. 201, as amended; 202, 206, 88

Stat. 1242, as amended; 1244, 1246 (42 U.S.C. 5841, 5842, 5846);

Pub. L. 95-601, sec. 10, 92 Stat. 2951 as amended by Pub. L. 102-

486, sec. 7902, 106 Stat. 3123 (42 U.S.C. 5851); sec. 102, Pub. L.

91-190, 83 Stat. 853 (42 U.S.C. 4332); secs. 131, 132, 133, 135,

137, 141, Pub. L. 97-425, 96 Stat. 2229, 2230, 2232, 2241; sec. 148,

Pub. L. 100-203, 101 Stat. 1330-235 (42 U.S.C. 10151, 10152, 10153,

10155, 10157, 10161, 10168).

Section 72.44(g) also issued under secs. 142(b) and 148(c), (d),

Pub. L. 100-203, 101 Stat. 1330-232, 1330-236 (42 U.S.C. 10162(b),

10168(c), (d)). Section 72.46 also issued under sec. 189, 68 Stat. 955

(42 U.S.C. 2239); sec. 134, Pub. L. 97-425, 96 Stat. 2230 (42 U.S.C.

10154). Section 72.96(d) also issued under sec. 145(g), Pub. L. 100-

203, 101 Stat. 1330-235 (42 U.S.C. 10165(g)). Subpart J also issued

under secs. 2(2), 2(15), 2(19), 117(a), 141(h), Pub. L. 97-425, 96

Stat. 2202, 2203, 2204, 2222, 2224 (42 U.S.C. 10101, 10137(a),

10161(h)). Subparts K and L are also issued under sec. 133, 98 Stat.

2230 (42 U.S.C. 10153) and sec. 218(a), 96 Stat. 2252 (42 U.S.C.

10198).

2. In Sec. 72.2, paragraph (b) is revised to read as follows:

Sec. 72.2 Scope.

* * * * *

(b) The regulations in this part pertaining to an independent spent

fuel storage installation (ISFSI) and a spent fuel storage cask apply

to all persons in the United States, including persons in Agreement

States. The regulations in this part pertaining to a monitored

retrievable storage installation (MRS) apply only to DOE.

* * * * *

3. In Sec. 72.3, the definitions of Certificate holder, Certificate

of Compliance or CoC, and Spent fuel storage cask or cask are added in

alphabetical order, and the definitions of Design bases, Design

capacity, and Structures, systems, and components important to safety

are revised to read as follows:

Sec. 72.3 Definitions.

* * * * *

Certificate holder means a person who has been issued a Certificate

of Compliance by the Commission for a spent fuel storage cask design.

Certificate of Compliance or CoC means the certificate issued by

the Commission that approves the design of a spent fuel storage cask in

accordance with the provisions of subpart L of this part.

* * * * * * *

Design bases means that information that identifies the specific

functions to be performed by a structure, system, or component of a

facility or of a spent fuel storage cask and the specific values or

[[Page 56122]]

ranges of values chosen for controlling parameters as reference bounds

for design. These values may be restraints derived from generally

accepted state-of-the-art practices for achieving functional goals or

requirements derived from analysis (based on calculation or

experiments) of the effects of a postulated event under which a

structure, system, or component must meet its functional goals. The

values for controlling parameters for external events include--

(1) Estimates of severe natural events to be used for deriving

design bases that will be based on consideration of historical data on

the associated parameters, physical data, or analysis of upper limits

of the physical processes involved; and

(2) Estimates of severe external man-induced events to be used for

deriving design bases that will be based on analysis of human activity

in the region, taking into account the site characteristics and the

risks associated with the event.

Design capacity means the quantity of spent fuel or high-level

radioactive waste, the maximum burn up of the spent fuel in MWD/MTU,

the terabequerel (curie) content of the waste, and the total heat

generation in Watts (btu/hour) that the storage installation is

designed to accommodate.

* * * * * * *

Spent fuel storage cask or cask means all the components and

systems associated with the container in which spent fuel or other

radioactive materials associated with spent fuel are stored in an

ISFSI.

* * * * * * *

Structures, systems, and components important to safety means those

features of the ISFSI, MRS, and spent fuel storage cask whose functions

are--

(1) To maintain the conditions required to store spent fuel or

high-level radioactive waste safely;

(2) To prevent damage to the spent fuel or the high-level

radioactive waste container during handling and storage; or

(3) To provide reasonable assurance that spent fuel or high-level

radioactive waste can be received, handled, packaged, stored, and

retrieved without undue risk to the health and safety of the public.

4. Section 72.9 is revised to read as follows:

Sec. 72.9 Information collection requirements: OMB approval.

(a) The Nuclear Regulatory Commission has submitted the information

collection requirements contained in this part to the Office of

Management and Budget (OMB) for approval as required by the Paperwork

Reduction Act of 1995 (44 U.S.C. 3501 et seq.). OMB has approved the

information collection requirements contained in this part under

control number 3150-0132.

(b) The approved information collection requirements contained in

this part appear in Secs. 72.7, 72.11, 72.16, 72.19, 72.22 through

72.34, 72.42, 72.44, 72.48 through 72.56, 72.62, 72.70 through 72.82,

72.90, 72.92, 72.94, 72.98, 72.100, 72.102, 72.104, 72.108, 72.120,

72.126, 72.140 through 72.176, 72.180 through 72.186, 72.192, 72.206,

72.212, 72.216, 72.218, 72.230, 72.232, 72.234, 72.236, 72.240, 72.242,

72.244, and 72.248.

5. In Sec. 72.10, the introductory text of paragraph (a), the

introductory text of paragraph (c), and paragraphs (c)(1) and (e)(1)

are revised to read as follows:

Sec. 72.10 Employee protection.

(a) Discrimination by a Commission licensee, certificate holder, an

applicant for a Commission license or a CoC, or a contractor or

subcontractor of any of these, against an employee for engaging in

certain protected activities, is prohibited. Discrimination includes

discharge and other actions that relate to compensation, terms,

conditions, or privileges of employment. The protected activities are

established in section 211 of the Energy Reorganization Act of 1974, as

amended, and in general are related to the administration or

enforcement of a requirement imposed under the Atomic Energy Act or the

Energy Reorganization Act.

* * * * * * *

(c) A violation of paragraph (a), (e), or (f) of this section by a

Commission licensee, certificate holder, applicant for a Commission

license or a CoC, or a contractor or subcontractor of any of these may

be grounds for:

(1) Denial, revocation, or suspension of the license or the CoC.

* * * * *

(e)(1) Each licensee, certificate holder, and applicant for a

license or CoC must prominently post the revision of NRC Form 3,

``Notice to Employees,'' referenced in 10 CFR 19.11(c). This form must

be posted at locations sufficient to permit employees protected by this

section to observe a copy on the way to or from their place of work.

The premises must be posted not later than 30 days after an application

is docketed and remain posted while the application is pending before

the Commission, during the term of the license or CoC, and for 30 days

following license or CoC termination.

* * * * *

6. Section 72.11 is revised to read as follows:

Sec. 72.11 Completeness and accuracy of information.

(a) Information provided to the Commission by a licensee,

certificate holder, or an applicant for a license or CoC; or

information required by statute or by the Commission's regulations,

orders, license or CoC conditions, to be maintained by the licensee or

certificate holder, must be complete and accurate in all material

respects.

(b) Each licensee, certificate holder, or applicant for a license

or CoC must notify the Commission of information identified by the

licensee, certificate holder, or applicant for a license or CoC as

having, for the regulated activity, a significant implication for

public health and safety or common defense and security. A licensee,

certificate holder, or an applicant for a license or CoC violates this

paragraph only if the licensee, certificate holder, or applicant for a

license or CoC fails to notify the Commission of information that the

licensee, certificate holder, or applicant for a license or CoC has

identified as having a significant implication for public health and

safety or common defense and security. Notification must be provided to

the Administrator of the appropriate Regional Office within two working

days of identifying the information. This requirement is not applicable

to information which is already required to be provided to the

Commission by other reporting or updating requirements.

7. In Sec. 72.86, paragraph (b) is revised to read as follows:

Sec. 72.86 Criminal penalties.

* * * * *

(b) The regulations in this part 72 that are not issued under

sections 161b, 161i, or 161o for the purposes of section 223 are as

follows: Secs. 72.1, 72.2, 72.3, 72.4, 72.5, 72.7, 72.8, 72.9, 72.16,

72.18, 72.20, 72.22, 72.24, 72.26, 72.28, 72.32, 72.34, 72.40, 72.46,

72.56, 72.58, 72.60, 72.62, 72.84, 72.86, 72.90, 72.96, 72.108, 72.120,

72.122, 72.124, 72.126, 72.128, 72.130, 72.182, 72.194, 72.200, 72.202,

72.204, 72.206, 72.210, 72.214, 72.220, 72.230, 72.238, 72.240, 72.244,

and 72.246.

8. Subpart G is revised to read as follows:

Subpart G--Quality Assurance

Sec.

72.140 Quality assurance requirements.

72.142 Quality assurance organization.

72.144 Quality assurance program.

[[Page 56123]]

72.146 Design control.

72.148 Procurement document control.

72.150 Instructions, procedures, and drawings.

72.152 Document control.

72.154 Control of purchased material, equipment, and services.

72.156 Identification and control of materials, parts, and

components.

72.158 Control of special processes.

72.160 Licensee and certificate holder inspection.

72.162 Test control.

72.164 Control of measuring and test equipment.

72.166 Handling, storage, and shipping control.

72.168 Inspection, test, and operating status.

72.170 Nonconforming materials, parts, or components.

72.172 Corrective action.

72.174 Quality assurance records.

72.176 Audits.

Subpart G--Quality Assurance

Sec. 72.140 Quality assurance requirements.

(a) Purpose. This subpart describes quality assurance requirements

that apply to design, purchase, fabrication, handling, shipping,

storing, cleaning, assembly, inspection, testing, operation,

maintenance, repair, modification of structures, systems, and

components, 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 and applicant for a

CoC 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 storage cask is transferred to

the licensee. The licensee and the certificate holder are also

simultaneously responsible for these quality assurance requirements

through the oversight of contractors and subcontractors.

(b) Establishment of program. Each licensee, applicant for a

license, certificate holder, applicant for a CoC 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, and applicant's for a CoC activities.

The licensee, applicant for a license, certificate holder, and

applicant for a CoC shall execute the applicable criteria in a graded

approach to an extent that is commensurate with the quality assurance

requirements' importance to safety. The quality assurance program must

cover the activities identified in this subpart throughout the life of

the activity. For licensees, this includes activities from the site

selection through decommissioning prior 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) Each licensee, applicant for a

license, certificate holder, and applicant for a CoC shall file a

description, in accordance with Sec. 72.4, of its quality assurance

program that includes a discussion of which requirements of this

subpart are applicable and the methodology used to satisfy these

requirements.

(2) Each licensee shall obtain Commission approval of its quality

assurance program prior to receipt of spent fuel at the ISFSI or spent

fuel and high-level radioactive waste at the MRS.

(3) Each certificate holder shall obtain Commission approval of its

quality assurance program prior to commencing fabrication or testing of

a spent fuel storage cask.

(d) Previously approved programs. A quality assurance program

previously approved by the Commission and which is established,

maintained, and executed with regard to an ISFSI or spent fuel storage

cask will be accepted as satisfying the requirements of paragraph (b)

of this section. Previously approved quality assurance programs that

satisfy the requirements of Appendix B to part 50 of this chapter,

subpart H of part 71 of this chapter, or subpart G of this part are

considered acceptable, except each licensee, applicant for a license,

certificate holder, and applicant for a CoC who are using an Appendix B

or subpart H quality assurance program shall also meet the

recordkeeping requirements of Sec. 72.174. Prior to initial use of a

previously approved program, each licensee, applicant for a license,

certificate holder, and applicant for a CoC shall notify the NRC, in

accordance with Sec. 72.4, of its intent to apply its previously

approved quality assurance program to ISFSI or spent fuel storage cask

activities. The notification must identify the quality assurance

program by date of submittal to the Commission, docket number, and date

of Commission approval.

Sec. 72.142 Quality assurance organization.

(a) The licensee, applicant for a license, certificate holder, and

applicant for a CoC shall be responsible for the establishment and

execution of the quality assurance program. The licensee and

certificate holder may delegate to others, such as contractors, agents,

or consultants, the work of establishing and executing the quality

assurance program, but the licensee and the certificate holder shall

retain responsibility for the program. The licensee, applicant for a

license, certificate holder, and applicant for a CoC shall clearly

establish and delineate in writing the authority and duties of persons

and organizations performing activities affecting the functions of

structures, systems, and components which are important to safety.

These activities include performing the functions associated with

attaining quality objectives and the quality assurance functions.

(b) The quality assurance functions are--

(1) Assuring that an appropriate quality assurance program is

established and effectively executed; and

(2) Verifying, by procedures such as checking, auditing, and

inspection, that activities affecting the functions that are important

to safety have been correctly performed. The persons and organizations

performing quality assurance functions shall have sufficient authority

and organizational freedom to identify quality problems; to initiate,

recommend, or provide solutions; and to verify implementation of

solutions.

(c) The persons and organizations performing quality assurance

functions shall report to a management level that ensures that the

required authority and organizational freedom, including sufficient

independence from cost and schedule considerations when these

considerations are opposed to safety considerations, are provided.

Because of the many variables involved, such as the number of

personnel, the type of activity being performed, and the location or

locations where activities are performed, the organizational structure

for executing the quality assurance program may take various forms,

provided that the persons and organizations assigned the quality

assurance functions have the required authority and organizational

freedom. Irrespective of the organizational structure, the

individual(s) assigned the responsibility for assuring effective

execution of any portion of the quality assurance program, at any

location where activities subject to this section are being performed,

must have direct

[[Page 56124]]

access to the levels of management necessary to perform this function.

Sec. 72.144 Quality assurance program.

(a) The licensee, applicant for a license, certificate holder, and

applicant for a CoC shall establish, at the earliest practicable time

consistent with the schedule for accomplishing the activities, a

quality assurance program which complies with the requirements of this

subpart. The licensee, applicant for a license, certificate holder, and

applicant for a CoC shall document the quality assurance program by

written procedures or instructions and shall carry out the program in

accordance with these procedures throughout the period during which the

ISFSI or MRS is licensed or the spent fuel storage cask is certified.

The licensee, applicant for a license, certificate holder, and

applicant for a CoC shall identify the structures, systems, and

components to be covered by the quality assurance program, the major

organizations participating in the program, and the designated

functions of these organizations.

(b) The licensee, applicant for a license, certificate holder, and

applicant for a CoC, through their quality assurance program(s), shall

provide control over activities affecting the quality of the identified

structures, systems, and components to an extent commensurate with the

importance to safety and, as necessary, to ensure conformance with the

approved design of each ISFSI, MRS, or spent fuel storage cask. The

licensee, applicant for a license, certificate holder, and applicant

for a CoC shall ensure that activities affecting quality are

accomplished under suitably controlled conditions. Controlled

conditions include the use of appropriate equipment; suitable

environmental conditions for accomplishing the activity, such as

adequate cleanliness; and assurance that all prerequisites for the

given activity have been satisfied. The licensee, applicant for a

license, certificate holder, and applicant for a CoC shall take into

account the need for special controls, processes, test equipment, tools

and skills to attain the required quality and the need for verification

of quality by inspection and test.

(c) The licensee, applicant for a license, certificate holder, and

applicant for a CoC shall base the requirements and procedures of their

quality assurance program(s) on the following considerations concerning

the complexity and proposed use of the structures, systems, or

components:

(1) The impact of malfunction or failure of the item on safety;

(2) The design and fabrication complexity or uniqueness of the

item;

(3) The need for special controls and surveillance over processes

and equipment;

(4) The degree to which functional compliance can be demonstrated

by inspection or test; and

(5) The quality history and degree of standardization of the item.

(d) The licensee, applicant for a license, certificate holder, and

applicant for a CoC shall provide for indoctrination and training of

personnel performing activities affecting quality as necessary to

ensure that suitable proficiency is achieved and maintained.

(e) The licensee, applicant for a license, certificate holder, and

applicant for a CoC shall review the status and adequacy of the quality

assurance program at established intervals. Management of other

organizations participating in the quality assurance program must

regularly review the status and adequacy of that part of the quality

assurance program which they are executing.

Sec. 72.146 Design control.

(a) The licensee, applicant for a license, certificate holder, and

applicant for a CoC shall establish measures to ensure that applicable

regulatory requirements and the design basis, as specified in the

license or CoC application for those structures, systems, and

components to which this section applies, are correctly translated into

specifications, drawings, procedures, and instructions. These measures

must include provisions to ensure that appropriate quality standards

are specified and included in design documents and that deviations from

standards are controlled. Measures must be established for the

selection and review for suitability of application of materials,

parts, equipment, and processes that are essential to the functions of

the structures, systems, and components which are important to safety.

(b) The licensee, applicant for a license, certificate holder, and

applicant for a CoC shall establish measures for the identification and

control of design interfaces and for coordination among participating

design organizations. These measures must include the establishment of

written procedures among participating design organizations for the

review, approval, release, distribution, and revision of documents

involving design interfaces. The design control measures must provide

for verifying or checking the adequacy of design by methods such as

design reviews, alternate or simplified calculational methods, or by a

suitable testing program. For the verifying or checking process, the

licensee and certificate holder shall designate individuals or groups

other than those who were responsible for the original design, but who

may be from the same organization. Where a test program is used to

verify the adequacy of a specific design feature in lieu of other

verifying or checking processes, the licensee and certificate holder

shall include suitable qualification testing of a prototype or sample

unit under the most adverse design conditions. The licensee, applicant

for a license, certificate holder, and applicant for a CoC shall apply

design control measures to items such as the following: criticality

physics, radiation, shielding, stress, thermal, hydraulic, and accident

analyses; compatibility of materials; accessibility for inservice

inspection, maintenance, and repair; features to facilitate

decontamination; and delineation of acceptance criteria for inspections

and tests.

(c) The licensee, applicant for a license, certificate holder, and

applicant for a CoC shall subject design changes, including field

changes, to design control measures commensurate with those applied to

the original design. Changes in the conditions specified in the license

or CoC require prior NRC approval.

Sec. 72.148 Procurement document control.

The licensee, applicant for a license, certificate holder, and

applicant for a CoC 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, equipment, and services, whether

purchased by the licensee, certificate holder, or by their contractors

and subcontractors. To the extent necessary, the licensee, applicant

for a license, certificate holder, and applicant for a CoC, shall

require contractors or subcontractors to provide a quality assurance

program consistent with the applicable provisions of this subpart.

Sec. 72.150 Instructions, procedures, and drawings.

The licensee, applicant for a license, certificate holder, and

applicant for a CoC 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

[[Page 56125]]

quantitative or qualitative acceptance criteria for determining that

important activities have been satisfactorily accomplished.

Sec. 72.152 Document control.

The licensee, applicant for a license, certificate holder, and

applicant for a CoC shall establish measures to control the issuance of

documents such as instructions, procedures, and drawings, including

changes, which prescribe all activities affecting quality. These

measures must assure that documents, including changes, are reviewed

for adequacy, approved for release by authorized personnel, and

distributed and used at the location where the prescribed activity is

performed. These measures must ensure that changes to documents are

reviewed and approved.

Sec. 72.154 Control of purchased material, equipment, and services.

(a) The licensee, applicant for a license, certificate holder, and

applicant for a CoC shall establish measures to ensure that purchased

material, equipment, and services, whether purchased directly or

through contractors and subcontractors, conform to the procurement

documents. These measures must include provisions, as appropriate, for

source evaluation and selection, objective evidence of quality

furnished by the contractor or subcontractor, inspection at the

contractor or subcontractor source, and examination of products upon

delivery.

(b) The licensee, applicant for a license, certificate holder, and

applicant for a CoC shall have available documentary evidence that

material and equipment conform to the procurement specifications prior

to installation or use of the material and equipment. The licensee and

certificate holder shall retain or have available this documentary

evidence for the life of the ISFSI, MRS, or spent fuel storage cask.

The licensee and certificate holder shall ensure that the evidence is

sufficient to identify the specific requirements met by the purchased

material and equipment.

(c) The licensee, applicant for a license, certificate holder, and

applicant for a CoC, or a designee of either, shall assess the

effectiveness of the control of quality by contractors and

subcontractors at intervals consistent with the importance, complexity,

and quantity of the product or services.

Sec. 72.156 Identification and control of materials, parts, and

components.

The licensee, applicant for a license, certificate holder, and

applicant for a CoC shall establish measures for the identification and

control of materials, parts, and components. These measures must ensure

that identification of the item is maintained by heat number, part

number, serial number, or other appropriate means, either on the item

or on records traceable to the item as required, throughout

fabrication, installation, and use of the item. These identification

and control measures must be designed to prevent the use of incorrect

or defective materials, parts, and components.

Sec. 72.158 Control of special processes.

The licensee, applicant for a license, certificate holder, and

applicant for a CoC shall establish measures to ensure that special

processes, including welding, heat treating, and nondestructive

testing, are controlled and accomplished by qualified personnel using

qualified procedures in accordance with applicable codes, standards,

specifications, criteria, and other special requirements.

Sec. 72.160 Licensee and certificate holder inspection.

The licensee, applicant for a license, certificate holder, and

applicant for a CoC shall establish and execute a program for

inspection of activities affecting quality by or for the organization

performing the activity to verify conformance with the documented

instructions, procedures, and drawings for accomplishing the activity.

The inspection must be performed by individuals other than those who

performed the activity being inspected. Examinations, measurements, or

tests of material or products processed must be performed for each work

operation where necessary to assure quality. If direct inspection of

processed material or products cannot be carried out, indirect control

by monitoring processing methods, equipment, and personnel must be

provided. Both inspection and process monitoring must be provided when

quality control is inadequate without both. If mandatory inspection

hold points that require witnessing or inspecting by the licensee's or

certificate holder's designated representative, and beyond which work

should not proceed without the consent of its designated

representative, are required, the specific hold points must be

indicated in appropriate documents.

Sec. 72.162 Test control.

The licensee, applicant for a license, certificate holder, and

applicant for a CoC shall establish a test program to ensure that all

testing, required to demonstrate that the structures, systems, and

components will perform satisfactorily in service, is identified and

performed in accordance with written test procedures that incorporate

the requirements of this part and the requirements and acceptance

limits contained in the ISFSI, MRS, or spent fuel storage cask license

or CoC. The test procedures must include provisions to ensure that all

prerequisites for the given test are met, that adequate test

instrumentation is available and used, and that the test is performed

under suitable environmental conditions. The licensee, applicant for a

license, certificate holder, and applicant for a CoC shall document and

evaluate the test results to ensure that test requirements have been

satisfied.

Sec. 72.164 Control of measuring and test equipment.

The licensee, applicant for a license, certificate holder, and

applicant for a CoC shall establish measures to ensure that tools,

gauges, instruments, and other measuring and testing devices used in

activities affecting quality are properly controlled, calibrated, and

adjusted at specified periods to maintain accuracy within necessary

limits.

Sec. 72.166 Handling, storage, and shipping control.

The licensee, applicant for a license, certificate holder, and

applicant for a CoC shall establish measures to control, in accordance

with work and inspection instructions, the handling, storage, shipping,

cleaning, and preservation of materials and equipment to prevent damage

or deterioration. When necessary for particular products, special

protective environments, such as inert gas atmosphere, and specific

moisture content and temperature levels must be specified and provided.

Sec. 72.168 Inspection, test, and operating status.

(a) The licensee, applicant for a license, certificate holder, and

applicant for a CoC shall establish measures to indicate, by the use of

markings such as stamps, tags, labels, routing cards, or other suitable

means, the status of inspections and tests performed upon individual

items of the ISFSI, MRS, or spent fuel storage cask. These measures

must provide for the identification of items which have satisfactorily

passed required inspections and tests where necessary to preclude

inadvertent bypassing of the inspections and tests.

(b) The licensee shall establish measures to identify the operating

status of structures, systems, and components of the ISFSI or MRS, such

as tagging

[[Page 56126]]

valves and switches, to prevent inadvertent operation.

Sec. 72.170 Nonconforming materials, parts, or components.

The licensee, applicant for a license, certificate holder, and

applicant for a CoC shall establish measures to control materials,

parts, or components that do not conform to their requirements in order

to prevent their inadvertent use or installation. These measures must

include, as appropriate, procedures for identification, documentation,

segregation, disposition, and notification to affected organizations.

Nonconforming items must be reviewed and accepted, rejected, repaired,

or reworked in accordance with documented procedures.

Sec. 72.172 Corrective action.

The licensee, applicant for a license, certificate holder, and

applicant for a CoC shall establish measures to ensure that conditions

adverse to quality, such as failures, malfunctions, deficiencies,

deviations, defective material and equipment, and nonconformances, are

promptly identified and corrected. In the case of a significant

condition identified as adverse to quality, the measures must ensure

that the cause of the condition is determined and corrective action is

taken to preclude repetition. The identification of the significant

condition adverse to quality, the cause of the condition, and the

corrective action taken must be documented and reported to appropriate

levels of management.

Sec. 72.174 Quality assurance records.

The licensee, applicant for a license, certificate holder, and

applicant for a CoC shall maintain sufficient records to furnish

evidence of activities affecting quality. The records must include the

following: design records, records of use, and the results of reviews,

inspections, tests, audits, monitoring of work performance, and

materials analyses. The records must include closely related data such

as qualifications of personnel, procedures, and equipment. Inspection

and test records must, at a minimum, identify the inspector or data

recorder, the type of observation, the results, the acceptability, and

the action taken in connection with any noted deficiencies. Records

must be identifiable and retrievable. Records pertaining to the design,

fabrication, erection, testing, maintenance, and use of structures,

systems, and components important to safety must be maintained by or

under the control of the licensee or certificate holder until the NRC

terminates the license or CoC.

Sec. 72.176 Audits.

The licensee, applicant for a license, certificate holder, and

applicant for a CoC shall carry out a comprehensive system of planned

and periodic audits to verify compliance with all aspects of the

quality assurance program and to determine the effectiveness of the

program. The audits must be performed in accordance with written

procedures or checklists by appropriately trained personnel not having

direct responsibilities in the areas being audited. Audited results

must be documented and reviewed by management having responsibility in

the area audited. Follow-up action, including reaudit of deficient

areas, must be taken where indicated.

9. Section 72.232 is revised to read as follows:

Sec. 72.232 Inspection and tests.

(a) The certificate holder and applicant for a CoC shall permit,

and make provisions for, the NRC to inspect the premises and facilities

where a spent fuel storage cask is designed, fabricated, and tested.

(b) The certificate holder and applicant for a CoC shall make

available to the NRC for inspection, upon reasonable notice, records

kept by them pertaining to the design, fabrication, and testing of

spent fuel storage casks.

(c) The certificate holder and applicant for a CoC shall perform,

and make provisions that permit the NRC to perform, tests that the

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 Sec. 72.4 at least 45 days prior to starting

fabrication of the first spent fuel storage cask under a Certificate of

Compliance.

10. Section 72.234 is revised to read as follows:

Sec. 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 Sec. 72.236.

(b) The certificate holder and applicant for a CoC shall ensure

that the design, fabrication, testing, and maintenance of spent fuel

storage casks are 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 spent fuel storage casks under a CoC does not

begin prior to receipt of the CoC for the spent fuel storage cask.

(d)(1) The certificate holder shall ensure that a record is

established and maintained for each spent fuel storage cask fabricated

under the CoC.

(2) This record must include:

(i) The NRC CoC number;

(ii) The spent fuel storage cask model number;

(iii) The spent fuel storage cask identification number;

(iv) Date fabrication was started;

(v) Date fabrication was completed;

(vi) Certification that the spent fuel storage cask was designed,

fabricated, tested, and repaired in accordance with a quality assurance

program accepted by NRC;

(vii) Certification that inspections required by Sec. 72.236(j)

were performed and found satisfactory; and

(viii) The name and address of the licensee using the spent fuel

storage cask.

(3) The certificate holder shall supply the original of this record

to the licensees using the spent fuel storage cask. A current copy of a

composite record of all spent fuel storage 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

spent fuel storage cask. If the certificate holder permanently ceases

production of spent fuel storage casks under a CoC, the certificate

holder shall send this composite record to the Commission using

instructions in Sec. 72.4.

(e) The certificate holder and the licensees using the spent fuel

storage cask shall ensure that the composite record required by

paragraph (d) of this section is available to the Commission for

inspection.

(f) The certificate holder shall ensure that written procedures and

appropriate tests are established prior to use of the spent fuel

storage casks. A copy of these procedures and tests must be provided to

each licensee using the spent fuel storage cask.

11. Section 72.236 is revised to read as follows:

Sec. 72.236 Specific requirements for spent fuel storage cask approval

and fabrication.

The certificate holder shall ensure that the requirements of this

section are met. An applicant for a CoC shall ensure that the

requirements of this section are met, except for paragraphs (j) and (k)

of this section.

(a) Specifications must be provided for the spent fuel to be stored

in the

[[Page 56127]]

spent fuel storage cask, such as, but not limited to, type of spent

fuel (i.e., BWR, PWR, both), maximum allowable enrichment of the fuel

prior to any irradiation, burn-up (i.e., megawatt-days/MTU), minimum

acceptable cooling time of the spent fuel prior to storage in the spent

fuel storage cask, maximum heat designed to be dissipated, maximum

spent fuel loading limit, condition of the spent fuel (i.e., intact

assembly or consolidated fuel rods), the inerting atmosphere

requirements.

(b) Design bases and design criteria must be provided for

structures, systems, and components important to safety.

(c) The spent fuel storage cask must be designed and fabricated so

that the spent fuel is maintained in a subcritical condition under

credible conditions.

(d) Radiation shielding and confinement features must be provided

sufficient to meet the requirements in Secs. 72.104 and 72.106.

(e) The spent fuel storage cask must be designed to provide

redundant sealing of confinement systems.

(f) The spent fuel storage cask must be designed to provide

adequate heat removal capacity without active cooling systems.

(g) The spent fuel storage cask must be designed to store the spent

fuel safely for a minimum of 20 years and permit maintenance as

required.

(h) The spent fuel storage cask must be compatible with wet or dry

spent fuel loading and unloading facilities.

(i) The spent fuel storage cask must be designed to facilitate

decontamination to the extent practicable.

(j) The spent fuel storage cask must be inspected to ascertain that

there are no cracks, pinholes, uncontrolled voids, or other defects

that could significantly reduce its confinement effectiveness.

(k) The spent fuel storage cask must be conspicuously and durably

marked with--

(1) A model number;

(2) A unique identification number; and

(3) An empty weight.

(l) The spent fuel storage cask and its systems important to safety

must be evaluated, by appropriate tests or by other means acceptable to

the NRC, to demonstrate that they will reasonably maintain confinement

of radioactive material under normal, off-normal, and credible accident

conditions.

(m) To the extent practicable in the design of spent fuel storage

casks, consideration should be given to compatibility with removal of

the stored spent fuel from a reactor site, transportation, and ultimate

disposition by the Department of Energy.

12. Section 72.240 is revised to read as follows:

Sec. 72.240 Conditions for spent fuel storage cask reapproval.

(a) The certificate holder, a licensee using a spent fuel storage

cask, or the representative of a licensee using a spent fuel storage

cask shall apply for reapproval of the design of a spent fuel storage

cask.

(b) The application for reapproval of the design of a spent fuel

storage cask must be submitted not less than 30 days prior to the

expiration date of the CoC. When the applicant has submitted a timely

application for reapproval, the existing CoC will not expire until the

application for reapproval has been determined by the NRC. The

application must be accompanied by a safety analysis report (SAR). The

new SAR may reference the SAR originally submitted for the approved

spent fuel storage cask design.

(c) The design of a spent fuel storage cask will be reapproved if

the conditions in Sec. 72.238 are met, and the application includes a

demonstration that the storage of spent fuel has not significantly

adversely affected structures, systems, and components important to

safety.

13. Section 72.242 is added to read as follows:

Sec. 72.242 Recordkeeping and reports.

(a) Each certificate holder or applicant shall maintain any records

and produce any reports that may be required by the conditions of the

CoC or by the rules, regulations, and orders of the NRC in effectuating

the purposes of the Act.

(b) Records that are required by the regulations in this part or by

conditions of the CoC must be maintained for the period specified by

the appropriate regulation or the CoC conditions. If a retention period

is not specified, the records must be maintained until the NRC

terminates the CoC.

(c) Any record 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 NRC 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 delivered to a licensee,

when the design or fabrication deficiency affects the ability of

structures, systems, and components important to safety to perform

their intended safety function. The written report shall be sent to the

NRC in accordance with the requirements of Sec. 72.4. The report shall

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 recurrence;

(2) A clear, specific, narrative description of what occurred so

that knowledgeable 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 shall 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;

(iv) A list of systems or secondary functions that were also

affected for failures of components with multiple functions;

(v) The method of discovery of each component or system failure;

(vi) The manufacturer and model number (or other identification) of

each component that failed during the event;

(vii) The model and serial numbers of the affected spent fuel

storage casks; (viii) The licensees that have affected spent fuel

storage casks;

(3) An assessment of the safety consequences and implications of

the deficiency. This assessment shall include the availability of other

systems or components that could have performed the same function as

the components and systems that were affected;

(4) A description of any corrective actions planned as a result of

the deficiency, including those to reduce the probability of similar

occurrences in the future;

(5) Reference to any previous similar deficiencies at the same

facility that are known to the certificate holder; and

(6) The name and telephone number of a person within the

certificate holder's organization who is knowledgeable about the

deficiency and can provide additional information.

Dated at Rockville, Maryland, this 5th day of October, 1999.

[[Page 56128]]

For the Nuclear Regulatory Commission.

Andrew L. Bates,

Acting Secretary of the Commission.

[FR Doc. 99-26700 Filed 10-14-99; 8:45 am]

BILLING CODE 7590-01-P