[Federal Register Volume 69, Number 99 (Friday, May 21, 2004)]
[Rules and Regulations]
[Pages 29187-29192]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-11506]
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NUCLEAR REGULATORY COMMISSION
10 CFR Chapter I
Regulatory Analysis Guidelines: Final Criteria for the Treatment
of Individual Requirements in a Regulatory Analysis
AGENCY: Nuclear Regulatory Commission.
ACTION: Regulatory analysis guidelines.
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SUMMARY: The Nuclear Regulatory Commission (NRC) is issuing its final
criteria for the treatment of individual requirements in a regulatory
analysis, because aggregating or ``bundling'' different requirements in
a single regulatory analysis could potentially mask the inclusion of an
individual requirement that is not cost-justified. As a result of these
new criteria, the NRC will issue Revision 4 of its Regulatory Analysis
Guidelines, NUREG/BR-0058 in the near future.
[[Page 29188]]
FOR FURTHER INFORMATION CONTACT: Brian J. Richter, Office of Nuclear
Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC
20555-0001; telephone (301) 415-1978; e-mail [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
The NRC usually performs a regulatory analysis for an entire rule
in evaluating a proposed regulatory initiative to determine if the rule
is cost-justified. External stakeholders from the nuclear power
industry raised concerns that bundling different requirements in a
single regulatory analysis can potentially mask the inclusion of an
individual requirement when the net benefit from one of the
requirements supports a second requirement that is not cost-justified.
In order to address this concern, the NRC published proposed
criteria for the treatment of individual requirements in a regulatory
analysis for comment on April 18, 2003 (68 FR 19162).
II. Comments on the Proposed Criteria
After publishing its proposed criteria for the treatment of
individual requirements in a regulatory analysis, the NRC received two
sets of comments: one set from the Nuclear Energy Institute (NEI), an
organization responsible for establishing unified nuclear industry
policy on matters affecting the nuclear energy industry and the second
from the Nuclear Regulatory Services Group (NRSG), a consortium of
power reactor licensees.
In general, NEI states that the NRC's proposed criteria do not
adequately incorporate the relevant Commission guidance on this issue
and that the public comments made at a public meeting on March 21,
2002, were not taken into account by the NRC staff. The two areas of
concern to NEI were the NRC's criteria necessary to evaluate the
bundling of individual requirements and the NRC's guidance on using
subjective judgment in making bundling decisions.
The law firm of Ballard Spahr Andrews & Ingersoll, LLP, also
submitted a set of comments on behalf of the Nuclear Regulatory
Services Group (NRSG). NRSG calls the proposed criteria ``a positive
step in providing detailed guidance in this area for the first time''
and suggested some refinements of the criteria so that ``all proposed
new regulatory requirements receive a proper analysis of their costs
and benefits.''
Comment: NEI's initial comment was that on ``* * * rules that
provide risk-informed voluntary alternatives to current regulations, an
individual requirement should have to be cost-justified and integral to
the purpose of the rule rather than [NRC's position that it be] cost-
justified or integral to the purpose of the rule.'' NEI claims that the
NRC's criteria ``* * * would be a significant disincentive to
implementation of voluntary alternative requirements developed by
industry groups because of the lack of scrutable guidance regarding the
addition of individual requirements by the NRC staff.''
Response: The NRC believes that its position is correct with
respect to the need for each criterion to be considered as a basis for
bundling. NRC's position may be clearer if one considers requirements
that are not necessary to a rule as enhancements. Then, if one uses
NEI's criteria of requiring both conditions, i.e., being both cost-
beneficial and necessary, no enhancements to a rule would be tolerated
or should even be considered because an enhancement is not necessary to
the purpose of the rule. But a fundamental principle of cost-benefit
methodology is to select the alternative that achieves the largest net
benefit, which could conceivably be an alternative with enhancements.
Thus, NEI's position is tantamount to ignoring the cost-benefit
implications of any requirement that is not necessary to meet the
objective of the rule. Under NEI's approach, cost-beneficial
relaxations could not be included in a rulemaking if they were not
necessary to the purpose of the rule.
Alternatively, the NRC's position allows for the selection of the
alternative with the largest net benefit. Also, the NRC does not
believe that NEI has demonstrated how the proposed criteria would be a
``significant disincentive'' to the implementation of voluntary
alternative requirements developed by industry groups. As long as the
voluntary alternatives are shown to be cost-beneficial and result in no
decrease in safety from the NRC's proposed requirement, there should
not be a problem.
Comment: NEI notes that the phrase ``integral to the purpose of the
rule,'' used both in a Staff Requirements Memorandum (SRM), dated
January 19, 2001, and in the February 2002 preliminary criteria, was
subsequently dropped from the proposed criteria. The phrase relates to
whether a proposed requirement can be ``integral to the purpose of the
rule'' if the individual requirement is not cost-beneficial, not
required for compliance, and not required for adequate protection.
NEI's position is that the phrase should be included in the NRC's final
criteria.
Response: The NRC replaced the phrase ``integral to the purpose of
the rule'' as stated in the 2002 criteria, with ``necessary to the
purpose of the rule'' because NRC believes that ``necessary'' conveys a
clearer meaning. As discussed in both the proposed and final criteria
papers, a requirement is necessary to the purpose of the rule if it is
needed for the regulatory initiative to resolve the problems and
concerns, and meet the stated objectives that are the focus of the
regulatory initiative.
Comment: NEI believes that NRC analysts need more guidance on
making bundling judgments. They claim that because NRC's guidance is
confusing and provides no meaningful standard, it is easier for the NRC
staff to aggregate requirements without explanation.
Response: The NRC's guidance is consistent with that provided in
the Office of Management and Budget's (OMB) Circular A-4, ``Regulatory
Analysis'' issued September 17, 2003, in which OMB recognizes the need
to examine individual provisions separately and goes on to state:
Analyzing all possible combinations of provisions is impractical
if the number is large and interaction effects are widespread. You
need to use judgment to select the most significant or relevant
provisions for such analysis. You are expected to document all the
alternatives that were considered in a list or table and which were
selected for emphasis in the main analysis.
The OMB circular recognizes that judgment must be used for such
analyses. The level of analysis needs to be tempered by many factors
such as controversiality, complexity, magnitude of consequences, and
the like. Also, each regulatory analysis could possibly have unique
features that would likely affect the type of analysis that should be
done. Further, NRC final guidance will include reference to the OMB
circular and the NRC does not believe additional guidance is needed.
Comment: NEI claims that the use of an analyst's judgment as
proposed by the NRC relies too much on NRC management review and public
comment. They state: ``The burden should be on the NRC to provide
sufficient information to evaluate regulatory analysis decisions.''
Response: Regulatory analyses are well founded and rely on sound
judgments. This is done through peer review, management oversight,
review of public comments, etc., and reliance on the analyst's judgment
which is central to the regulatory analysis process. The NRC believes
that its guidance ensures that its regulatory
[[Page 29189]]
analyses will provide sufficient information for the public to evaluate
regulatory decisions and makes the process both ``meaningful and
scrutable.''
Comment: NEI quotes the SRM calling for regulatory analyses to be
``meaningful and scrutable'' and claims that the analysis cannot meet
this requirement unless there is some documented basis for
disaggregation.
Response: The NRC believes that regulatory analyses prepared under
the revised guidelines are ``meaningful and scrutable,'' especially
given that the guidance is consistent with that provided by OMB on this
issue. The reason for disaggregation would be discussed in each
regulatory analysis on a case-by-case basis.
Comment: NEI states that the proposed criteria are inconsistent
with the other detailed guidance on the treatment of values and impacts
contained in NUREG/BR/0058, as currently written.
Response: The NRC disagrees with this comment and believes this
final guidance clarifies and supports existing guidance in NUREG/BR-
0058. Further, the NRC believes this new guidance is directly relevant
to the current discussion on the identification of alternatives. This
guidance considers the scope of requirements and the variability in
physical and technical requirements as bases for defining alternatives.
This bundling issue should be viewed as an extension or clarification
of that discussion.
Comment: NEI states with respect to bundling that the ``proposed
criteria do not establish a common understanding of new requirements,
do not establish a scrutable process for making regulatory decisions
about voluntary initiatives, and do not provide sufficient
documentation to inform future decisions.''
Response: The NRC reiterates its position that ``bundling''
guidance sets forth in detail how an analyst should handle the
``bundling'' issue and is also consistent with the cited OMB guidance.
The NRC also believes that regulatory analyses and supporting
documentation prepared under the revised guidance will be sufficient to
provide documentation which may be reviewed to inform future decisions.
The NRC notes that regulatory analyses are prepared as tools to support
reasoned decision making and public understanding of the NRC's
decisions; in this regard, the NRC believes that the revised guidelines
achieve these objectives.
Comment: NEI requests that the NRC defer its final decision on
these criteria until previous comments are ``properly addressed.''
Response: Sufficient information was not provided to defer a final
decision. The NRC maintains that it has properly addressed all public
comments. Also, the Advisory Committee on Reactor Safeguards has stated
in a July 17, 2003, letter from its Chairman, Mario V. Bonaca, to the
Chairman of the Commission, that the NRC staff's criteria ``are
appropriate and responsive to the Commission's direction.''
Comment: NRSG stated that the NRC should require separate analysis
of individual requirements to the extent practicable. They went on to
state ``that disaggregation of requirements should be the preferred
approach, with the burden on the NRC to justify why separate analysis
of individual requirements is not appropriate in a given case.''
Response: The NRC acknowledges that, for the purposes of developing
an overall cost estimate of a regulatory initiative, the analyst should
obtain separate cost estimates for each individual requirement to the
extent practical. This is because it is the most logical model for
developing an overall cost estimate, namely a bottom up approach.
Further, the NRC agrees that cost-benefit analyses of individual
requirements that are related (but not necessary) to the overall
regulatory initiative need to be considered in reaching a sound
regulatory decision. However, it is important to remember that the
underlying purpose of a regulatory analysis is to provide decision
makers with a tool for choosing between options or alternatives. When a
regulatory initiative has a number of discreet, yet necessary
requirements, the decision maker's choice is not whether to include or
exclude necessary individual requirements but, rather, whether or not
to enact the initiative as a whole. Therefore, the separate analyses of
necessary individual requirements cannot contribute to this decision.
Further, as stated in the proposed criteria, published for public
comment in the Federal Register on April 18, 2003 (68 FR 19162):
``Specifically, this guidance states that a decision on the level of
disaggregation needs to be tempered by considerations of reasonableness
and practicality, and that a more detailed disaggregation would only be
appropriate if it produces substantially different alternatives with
potentially meaningful results.'' This implies that the analyst must be
able to demonstrate that any aggregation in the analysis would not
result in different conclusions of the analysis. Therefore, the NRC
still does not believe that disaggregation in all cases should be the
preferred approach and stands by the position stated in the proposed
criteria. As stated in the guidance, ``the NRC does not believe that
there should be a general requirement for a separate analysis of each
individual requirement of a rule. This could lead to unnecessary
complexities.'' Also, NRC believes that its guidance is consistent with
OMB Circular A-4, cited above.
Comment: NRSG states that if, according to the criteria, an
individual requirement must be both ``related'' to the stated objective
of the regulatory initiative and be ``cost-beneficial,'' then the NRC
should clarify what it means by ``cost-beneficial.'' The commenter also
states that the criteria for the treatment of any individual
requirement must be consistent with the standards of the backfitting
rule. Under the backfit rule, any new requirement that is a backfit
must be shown to be cost-justified and produce a ``substantial
increase'' in overall safety. Lastly, their final two points in this
section are in agreement with the NRC criteria. First, the commenter
agrees with the NRC that in ``cases where a new backfit requirement is
being considered for inclusion in a voluntary alternative, to current
regulations * * * NRC should consider imposing such a new requirement,
if justified under the standards of Section 50.109, through the normal
disciplined backfitting process, * * * rather than merely including it
in a voluntary-alternative rule.'' Second, NRSG ``agree(s) with the NRC
position that if an individual backfit requirement is not related to
the objective of the regulatory initiative * * * , the ``requirement
must be addressed and justified as a backfit separately.'''
Response: For the most part, the NRC agrees with these comments.
With respect to the NRC's meaning of ``cost-beneficial'' in the
situation discussed by the commenter, the NRC means that the regulatory
initiative results in a larger net benefit than would accrue to an
action without that requirement. Further, with respect to the backfit
rule, the NRC position is that when an individual requirement is
related to the stated regulatory objective, the individual requirement
should be cost-justified, and the overall regulatory initiative should
constitute a substantial increase in the public health and safety.
Comment: NRSG stated that there should be further guidance on
backfitting issues related to the American Society of Mechanical
Engineers (ASME) Code. Specifically, they state:
[[Page 29190]]
NRC's guidance should allow the NRC discretion to perform a
cost-benefit analysis of individual new requirements contained in
later editions of Section XI before they are incorporated wholesale
into Section 50.55a. If the NRC finds that individual new
requirements of later Code editions are not cost-beneficial for some
or all plants, the NRC should screen out those new individual
requirements in accordance with the standards of the backfitting
rule.
Response: The Commission's policy regarding Inservice Inspection
(ISI) requirements is to assure the integrity of the reactor coolant
system (RCS) boundary and containment as they relate to defense-in-
depth considerations, that do not lend themselves to cost-benefit
analyses. Further, in this specific instance, cost-benefit analyses are
not well suited to determine if new requirements that address aging of
components are appropriate because of the many uncertainties associated
with the effects of aging.
When the Commission formulated its policy, the then Chairman stated
that: ``Both the ASME and the ACRS have strongly urged that the
Commission maintain the current updating requirement'' and that--
ASME asserts that the failure of the NRC to incorporate later
editions of the Code in the requirements, absent justification under
a backfit analysis, would serve to undermine ASME because of the
disincentive of volunteers to engage themselves in an ASME process
that will not necessarily affect operating plants. Moreover, because
some states routinely establish requirements based on current ASME
codes, the acceptance of the staff's approach would create the
anomaly that non-nuclear facilities might be required to conform to
more modern codes than nuclear facilities.
The Chairman also indicated he was aware ``that industry
participates in the development of the ASME codes and that costs are
considered in the amendment process. Thus, although the revisions may
not be analyzed with the rigor required by our backfit analysis, the
costs and benefits are implicitly weighed.''
Another Commissioner commented:
10 CFR 50.109 has served the NRC, our licensees, and our
stakeholders well, and thus, my decision to not subject ASME Code
updates to its backfit provisions was made only after I carefully
considered how the staff's recommended option should exacerbate the
complexity, inconsistency, and program divergence associated with
our current update process. My decision also came after considering
the diverse makeup of the ASME members that produce Code changes and
the consensus process they use. * * * I believe that considerations
of increased safety versus cost are implicit in the ASME consensus
process.
In sum, NRSG's suggested approach is inconsistent with the
Commission's previous guidance to the staff.
III. Final Criteria
In evaluating a proposed regulatory initiative, the NRC usually
performs a regulatory analysis for the entire rule to determine whether
or not it is cost-justified. However, aggregating or ``bundling''
different requirements in a single analysis could potentially mask the
inclusion of an unnecessary individual requirement. In the case of a
rule that provides a voluntary alternative to current requirements, the
net benefit from the relaxation of one requirement could potentially
support a second unnecessary requirement that is not cost-justified.
Similarly, in the case of other types of rules, including those subject
to backfit analysis,\1\ the net benefit from one requirement could
potentially support another requirement that is not cost-justified.\2\
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\1\ 'The Regulatory Analysis Guidelines of the U.S. Nuclear
Regulatory Commission,'' (NUREG/BR-0058) have been developed so that
a regulatory analysis that conforms to these Guidelines will meet
the requirements of the backfit rule and the provisions of the CRGR
Charter.
\2\ This discussion does not apply to backfits that the
Commission determines qualify under one of the exceptions in 10 CFR
50.109(a)(4). Those types of backfits require a documented
evaluation rather than a backfit analysis, and cost is not a
consideration in deciding whether or not the exceptions are
justified (though costs may be considered in determining how to
achieve a certain level of protection).
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Therefore, when analyzing and making decisions about regulatory
initiatives that are composed of individual requirements, the NRC must
determine if it is appropriate to include each individual requirement.
Clearly, in certain instances, the inclusion of an individual
requirement is necessary. This would be the case, for example, when the
individual requirement is needed for the regulatory initiative to
resolve the problems and concerns and meet the stated objectives \3\
that are the focus of the regulatory initiative. Even though inclusion
of individual requirements is necessary in this case, the analyst
should obtain separate cost estimates for each requirement, to the
extent practical, in deriving the total cost estimate presented for the
aggregated requirements.
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\3\ The stated objectives of the rule are those stated in the
preamble (also known as the Statement of Considerations) of the
rule.
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However, there will also be instances in which the individual
requirement is not a necessary component of the regulatory initiative,
and thus the NRC will have some discretion regarding its inclusion. In
these circumstances, the NRC should adhere to the following guideline:
If the individual requirement is related (i.e., supportive but
not necessary) to the stated objective of the regulatory initiative,
it should be included only if its overall effect is to make the
bundled regulatory requirement more cost-beneficial. This would
involve a quantitative and/or qualitative evaluation of the costs
and benefits of the regulatory initiative with and without the
individual requirement included, and a direct comparison of those
results.\4\
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\4\ There may be circumstances in which the analyst considers
including an individual requirement that is unrelated to the overall
regulatory initiative. For example, an analyst may consider
combining certain unrelated requirements as a way to eliminate
duplicative rulemaking costs to the NRC and increase regulatory
efficiency. Under these circumstances, it would be appropriate to
combine these discrete individual requirements if the overall effect
is to make the regulatory initiative more cost-beneficial. In those
instances in which the individual requirement is a backfit, the
requirement must be addressed and justified as a backfit separately.
These backfits are not to be included in the overall regulatory
analysis of the remainder of the regulatory initiative.
In applying this guideline, the NRC will need to separate out the
discrete requirements in order to evaluate their effect on the cost-
benefit results. In theory, each regulatory initiative could include
several discretionary individual requirements and each of those
discretionary requirements could be comprised of many discrete steps,
in which each discrete step could be viewed as a distinct individual
requirement. This raises the potential for a large number of iterative
cost-benefit comparisons, with attendant analytical complexities. Thus,
considerable care needs to be given to the level of disaggregation that
one attaches to a discretionary requirement.
In general, a decision on the level of disaggregation needs to be
tempered by considerations of reasonableness and practicality. For
example, more detailed disaggregation is only appropriate if it
produces substantively different alternatives with potentially
meaningful implications on the cost-benefit results. Alternatively,
individual elements that contribute little to the overall costs and
benefits and are noncontroversial may not warrant much, if any,
consideration. In general, it will not be necessary to provide
additional documentation or analysis to explain how this determination
is made, although such a finding can certainly be challenged at the
public comment stage.\5\ For further guidance, the analyst is referred
to principles regarding the appropriate level of detail to be included
in a
[[Page 29191]]
regulatory analysis, as discussed in Chapter 4 of the ``Regulatory
Analysis Guidelines of the U.S. Nuclear Regulatory Commission.''
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\5\ See NUREG/BR-0053, Revision 5, March 2001, ``U.S. Nuclear
Regulatory Commission Regulations Handbook,'' Section 7.9, for
discussion of how to treat comments.
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In some cases, an individual requirement that is being considered
for inclusion in a voluntary alternative to current regulations may be
justifiable under the backfit criteria. In these cases the individual
requirement is both cost-justified and provides a substantial increase
in the overall protection of the public health and safety or the common
defense and security. If so, the NRC should consider imposing the
individual requirement as a backfit affecting all plants to which it
applies, rather than merely including it in a voluntary-alternative
rule affecting only those plants where the voluntary alternative is
adopted.
A special case involves the NRC's periodic review and endorsement
of consensus standards, such as new versions of the American Society of
Mechanical Engineers (ASME) codes. These NRC endorsements can typically
involve hundreds, if not thousands, of individual provisions. Thus,
evaluating the benefits and costs of each individual provision in a
regulatory analysis can be a monumental task. Further, the value gained
by performing such an exercise appears limited. These consensus
standards tend to be noncontroversial and have already undergone
extensive external review and been endorsed by industry. Although
regulatory actions endorsing these consensus standards must be
addressed in a regulatory analysis, it is usually not necessary for the
regulatory analysis to address the individual provisions of the
consensus standards.
The NRC believes this is appropriate for several reasons:
(1) It has been longstanding NRC policy to incorporate later
versions of the ASME Code into its regulations; and thus, licensees
know when receiving their operating licenses that updating the ASME
Code is part of the regulatory process;
(2) Endorsement of the ASME Code is consistent with the National
Technology Transfer and Advancement Act, inasmuch as the NRC has
determined that there are sound regulatory reasons for establishing
regulatory requirements for design, maintenance, inservice inspection
and inservice testing by rulemaking; and
(3) These consensus standards undergo significant external review
and discussion before being endorsed by the NRC.
Some aspects of these regulatory actions endorsing consensus
standards are backfits which must be addressed and justified
individually. For example, NRC endorsement (incorporation by reference)
of the ASME Boiler and Pressure Vessel Code (BPV) provisions on
inservice inspection and inservice testing, and the ASME Operations and
Maintenance (OM) Code, are not ordinarily considered backfits, because
it has been the NRC's longstanding policy to incorporate later versions
of the ASME codes into its regulations. However, under some
circumstances the NRC's endorsement of a later ASME BPV or OM Code is
treated as a backfit. The application of the backfit rule to ASME code
endorsements is discussed in the Appendix below. Aside from these
backfits, these regulatory analyses should include consideration of the
major features (e.g., process changes, recordkeeping requirements) of
the regulatory action which should then be aggregated to produce
qualitative or quantitative estimates of the overall burdens and
benefits in order to determine if the remainder of the action is
justified.
Dated in Rockville, Maryland, this 17th day of May, 2004.
For the Nuclear Regulatory Commission.
Annette Vietti-Cook,
Secretary of the Commission.
Note: The following appendix will not appear in the Code of
Federal Regulations.
Appendix
Guidance on Backfitting Related to ASME Codes
10 CFR 50.55a requires nuclear power plant licensees to
construct ASME Boiler and Pressure Vessel Code (BPV Code) Class 1,
2, and 3 components under the rules provided in Section III,
Division 1, of the ASME BPV Code; inspect Class 1, 2, 3, Class MC,
and Class CC components under the rules provided in Section XI,
Division 1, of the ASME BPV Code; and test Class 1, 2, and 3 pumps
and valves under the rules provided in the ASME Code for Operation
and Maintenance of Nuclear Power Plants (OM Code). From time to
time, the NRC amends 10 CFR 50.55a to incorporate by reference later
editions and addenda of: Section III, Division 1, of the ASME BPV
Code; Section XI, Division 1, of the ASME BPV Code; and the ASME OM
Code.
Section A. Incorporation by Reference of Later Editions and Addenda of
Section III, Division 1 of ASME BPV Code
Incorporation by reference of later editions and addenda of
Section III, Division 1, of the ASME BPV Code is prospective in
nature. The later editions and addenda do not affect a plant that
has received a construction permit or an operating license, or a
design that has been approved because the edition and addenda to be
used in constructing a plant are, by rule, determined on the basis
of the date of the construction permit and are not changed, except
voluntarily by the licensee. Thus, incorporation by reference of a
later edition and addenda of Section III, Division 1, does not
constitute a ``backfitting'' as defined in Sec. 50.109(a)(1).
Section B. Incorporation by reference of later editions and addenda of
Section XI, Division 1, of the ASME BPV and OM Codes
Incorporation by reference of later editions and addenda of
Section XI, Division 1, of the ASME BPV Code and the ASME OM Code
affect the ISI and IST programs of operating reactors. However, the
backfit rule generally does not apply to incorporation by reference
of later editions and addenda of the ASME BPV (Section XI) and OM
codes for the following reasons--
(1) The NRC's longstanding policy has been to incorporate later
versions of the ASME codes into its regulations; thus, licensees
know when receiving their operating licenses that such updating is
part of the regulatory process. This is reflected in Sec. 50.55a
which requires licensees to revise their in-service inspection (ISI)
and in-service-testing (IST) programs every 120 months to the latest
edition and addenda of Section XI of the ASME BPV Code and the ASME
OM Code incorporated by reference into Sec. 50.55a that is in
effect 12 months before the start of a new 120-month ISI and IST
interval. Thus, when the NRC endorses a later version of a code, it
is implementing this longstanding policy.
(2) ASME BPV and OM codes are national consensus standards
developed by participants with broad and varied interests, in which
all interested parties (including the NRC and utilities)
participate. This consideration is consistent with both the intent
and spirit of the backfit rule (i.e., the NRC provides for the
protection of the public health and safety, and does not
unilaterally imposed undue burden on applicants or licensees).
(3) Endorsement of these ASME codes is consistent with the
National Technology Transfer and Advancement Act, inasmuch as the
NRC has determined that there are sound regulatory reasons for
establishing regulatory requirements for design, maintenance,
inservice inspection and inservice testing by rulemaking.
Section C. Other Circumstances Where the NRC Does Not Apply the Backfit
Rule to the Endorsement of a Later Code
Other circumstances where the NRC does not apply the backfit
rule to the endorsement of a later code are as follows--
(1) When the NRC takes exception to a later ASME BPV or OM code
provision, and merely retains the current existing requirement,
prohibits the use of the later code provision, or limits the use of
the later code provision, the backfit rule does not apply because
the NRC is not imposing new requirements. However, the NRC provides
the technical and/or policy bases for taking exceptions to the code
in the Statement of Considerations for the rule.
(2) When an NRC exception relaxes an existing ASME BPV or OM
code provision but does not prohibit a licensee from using the
existing code provision.
[[Page 29192]]
Section D. Endorsement of Later ASME BPV or OM Codes That Are
Considered Backfits
There are some circumstances when the NRC considers it
appropriate to treat as a backfit the endorsement of a later ASME
BPV or OM code--
(1) When the NRC endorses a later provision of the ASME BPV or
OM code that takes a substantially different direction from the
currently existing requirements, the action is treated as a backfit.
An example was the NRC's initial endorsement of Subsections IWE and
IWL of Section XI, which imposed containment inspection requirements
on operating reactors for the first time. The final rule dated
August 8, 1996 (61 FR 41303), incorporated by reference in Sec.
50.55a the 1992 Edition with the 1992 Addenda of IWE and IWL of
Section XI to require that containments be routinely inspected to
detect defects that could compromise a containment's structural
integrity. This action expanded the scope of Sec. 50.55a to include
components that were not considered by the existing regulations to
be within the scope of ISI. Because those requirements involved a
substantially different direction, they were treated as backfits,
and justified under the standards of 10 CFR 50.109.
(2) When the NRC requires implementation of later ASME BPV or OM
code provision on an expedited basis, the action is treated as a
backfit. This applies when implementation is required sooner than it
would be required if the NRC simply endorsed the Code without any
expedited language. An example was the final rule dated September
22, 1999 (64 FR 51370), which incorporated by reference the 1989
Addenda through the 1996 Addenda of Section III and Section XI of
the ASME BPV Code, and the 1995 Edition with the 1996 Addenda of the
ASME OM Code. The final rule expedited the implementation of the
1995 Edition with the 1996 Addenda of Appendix VIII of Section XI of
the ASME BPV Code for qualification of personnel and procedures for
performing ultrasonic (UT) examinations. The expedited
implementation of Appendix VIII was considered a backfit because
licensees were required to implement the new requirements in
Appendix VIII before the next 120-month ISI program inspection
interval update. Another example was the final rule dated August 6,
1992 (57 FR 34666), which incorporated by reference in Sec. 50.55a
the 1986 Addenda through the 1989 Edition of Section III and Section
XI of the ASME BPV Code. The final rule added a requirement to
expedite the implementation of the revised reactor vessel shell weld
examinations in the 1989 Edition of Section XI. Imposing these
examinations was considered a backfit because licensees were
required to implement the examinations before the next 120-month ISI
program inspection interval update.
(3) When the NRC takes an exception to an ASME BPV or OM code
provision and imposes a requirement that is substantially different
from the current existing requirement as well as substantially
different than the later code. An example of this is presented in
the portion of the final rule dated September 19, 2002, in which the
NRC adopted dissimilar metal piping weld UT examination coverage
requirements from those in the ASME code.
[FR Doc. 04-11506 Filed 5-20-04; 8:45 am]
BILLING CODE 7590-01-P