[Federal Register Volume 64, Number 199 (Friday, October 15, 1999)]
[Rules and Regulations]
[Pages 56114-56128]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-26700]
[[Page 56113]]
_______________________________________________________________________
Part VI
Nuclear Regulatory Commission
_______________________________________________________________________
10 CFR Part 72
Expand Applicability of Part 72 to Holders of, and Applicants for,
Certificates of Compliance; Final Rule; NRC Enforcement Policy;
Enforcement Action Against Nonlicensees Under 10 CFR Part 72; Notice of
Policy Statement; Revision
Federal Register / Vol. 64, No. 199 / Friday, October 15, 1999 /
Rules and Regulations
[[Page 56114]]
NUCLEAR REGULATORY COMMISSION
10 CFR Part 72
RIN 3150-AF93
Expand Applicability of Part 72 to Holders of, and Applicants
for, Certificates of Compliance
AGENCY: Nuclear Regulatory Commission.
ACTION: Final rule.
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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, ajd@nrc.gov, 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
