[Federal Register Volume 69, Number 50 (Monday, March 15, 2004)]
[Proposed Rules]
[Pages 12088-12091]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-5736]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 69, No. 50 / Monday, March 15, 2004 /
Proposed Rules
[[Page 12088]]
NUCLEAR REGULATORY COMMISSION
10 CFR Part 71
Regulations for the Safe Transport of Radioactive Material;
Public Meeting
AGENCY: Nuclear Regulatory Commission.
ACTION: Advance notice of public meeting.
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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) and the U.S.
Department of Transportation (DOT) are convening a workshop with an
opportunity to discuss any operational concerns for implementing the
recently revised transportation regulations in 10 CFR part 71 and 49
CFR parts 171 through 178. Part of this workshop will include
discussions to obtain a path forward on the portion of the proposed
rule concerning 10 CFR part 71 change authority for dual-purpose
certificate holders that was not included in the final rule.
DATES: The workshop will be held on April 15, 2004, from 8:30 a.m. to
4:30 p.m.
ADDRESSES: The workshop will be conducted at the NRC Auditorium, Two
White Flint North, 11545 Rockville Pike, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: David Pstrak, Office of Nuclear
Materials Safety and Safeguards, U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001, telephone: (301) 415-8486; email:
[email protected].
SUPPLEMENTARY INFORMATION:
Background
On January 26, 2004, the Nuclear Regulatory Commission (NRC)
published a final rule (69 FR 3632) that amended the domestic
transportation regulations to make them compatible with the 1996
Edition of the International Atomic Energy Agency standards, and to
codify other requirements. NRC coordinated this rulemaking and final
rule publication with the Department of Transportation (DOT) to ensure
that consistent regulatory standards were maintained between NRC and
DOT radioactive material transportation regulations, and to ensure
joint publication of the final rules. The DOT also published its final
rule on January 26, 2004 (69 FR 3632). Both rules become effective on
October 1, 2004. During previous rulemakings, both agencies recognized
that implementing new requirements often led to questions on
specifically what was expected or how a new regulation was to be
exercised. To foster an open dialogue with a view towards understanding
where uncertainties exist regarding the new requirements, NRC and DOT
are seeking views during this open forum.
On April 30, 2002, the NRC published a proposed rule for a major
revision of 10 CFR part 71, Packaging and Transportation of Radioactive
Material (67 FR 21390). Among other items, the proposed rule included a
set of provisions that would allow certificate holders for dual-purpose
(storage and transport) spent fuel casks, designated as Type B(DP)
packages, to make certain changes to the transportation package without
prior NRC approval. When the final rule was issued on January 26, 2004
(69 FR 3698), the change authority provisions were not adopted. The NRC
staff determined that implementation of this change could result in new
regulatory burdens and significant costs, and that certain changes were
already authorized under current part 71 regulations. The NRC concluded
that additional stakeholder input was needed on the values and impacts
of this change before deciding whether to adopt a final rule providing
change authority. The following background paper will be used to guide
the discussion during the April 15, 2004, workshop.
Discussion Paper 10 CFR Part 71 Change Authority
Purpose
The purpose of this Discussion Paper is to identify additional
input stakeholders may wish to provide with respect to the values and
impacts of the proposed rule regarding 10 CFR part 71 change authority
for dual-purpose package certificate holders.
Plan for Resolution
This Discussion Paper is being issued as the first step in
addressing concerns identified with the implementation of the change
authority as proposed in 10 CFR part 71. This Discussion Paper
identifies specific information that the staff feels will be useful in
adequately evaluating the values and costs of implementing the change
authority contained in the proposed rule. The staff plans to hold open,
public discussions with stakeholders, to collect and evaluate the
information, and to then propose a resolution to the Commission. The
resolution will consist of issuing a final rule or withdrawing the
change authority proposal.
Provisions of the Proposed Rule
The proposed 10 CFR part 71 established a new subpart I for Type
B(DP) packages, and other related and conforming provisions. Subpart I
specified requirements for applying for a Type B(DP) package approval,
the contents of the application, and the package description and
evaluation. The proposed Sec. 71.153 would require the application for
a Type B(DP) package to include two parts. The first part, specified in
Sec. 71.153(a), is a package application which is the same as the
application requirements currently in effect for a Type B(U) package,
including essentially the same package evaluation and performance
standards. The second part is a new safety analysis report that among
other things includes ``an analysis of potential accidents, package
response to these potential accidents, and any consequences to the
public.'' It is this second part, the ``safety analysis report'' as
described in Sec. 71.153(b), and the associated potential accidents
and consequences, that would introduce additional, new requirements for
the Type B(DP) packages.
The safety analysis report is the document that would be used to
evaluate changes that could be made to the package design or operation
without prior NRC approval. The safety analysis report would include
the identification and evaluation of potential accidents, which are not
necessarily limited to the hypothetical accident conditions that are
currently used in part 71. It was envisioned that the safety analysis
report would develop an inclusive and rigorous identification and
evaluation of potential accidents. Accidents to be
[[Page 12089]]
considered could address both external natural events and man-induced
events. Man-induced events could include transportation accidents and
other accident types. It was also envisioned that accident
probabilities would be established, which is a departure from the
existing part 71 hypothetical accident conditions. In this regard, the
safety analysis report and its accident analysis are similar to the use
of those terms in 10 CFR part 72, the regulations that pertain to spent
fuel storage casks.
The consequence evaluation could also include other aspects not
embodied in the current part 71 regulatory framework. For example,
release limits for accident conditions are specified in the current
regulations, and not dose limits. For the new safety analysis report,
the identification of maximum exposed individuals and populations may
need to be addressed in the context of the transportation of the casks.
Environmental consequences, including pathway analyses, could also be
required. Transport routes and population distributions may be needed
for the evaluation, unlike current part 71 standards that are
fundamentally route and mode independent.
Type B(DP) package certificate holders would be authorized to make
certain changes to the package design and operations based on the
provisions in Sec. 71.175(c) of the proposed rule. The change
authority would be tied to the safety analysis report required by Sec.
71.153(b). Table 1 compares the proposed provisions with the current
rule with respect to evaluations and information that may be required
in a package application. The table also identifies the type of
information that may be needed in order to evaluate changes made under
the provisions of Sec. 71.175(c).
Table 1.--Comparison of Information and Evaluations Required Between Type B(DP) and Type B(U) Packages
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Provisions of the proposed rule Applicable sections
for type B(DP) package under under proposed Type B(DP) package Type B(U) package
subpart I subpart I
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Application for Package Approval.. 71.153(a)............ yes....................... yes.
Meets Package Approval Standards 71.153(a)(2), 71.157. yes....................... yes.
Under Subparts E.
Meets Performance Standards Under 71.153(a)(2), 71.157. yes....................... yes.
Subparts F.
Meets Quality Assurance Standards 71.153(a)(3), 71.159. yes....................... yes.
Under Subparts H.
Demonstrate Safe Use of Package... 71.153(b)(2)......... yes....................... no.
Evaluate Potential Accidents, 71.153(b)(3)......... yes....................... no.
Package Response, and
Consequences to Public.
Justification for At Least 20 71.153(b)(4)......... yes....................... no.
Years Usage.
Licensing Period for CoC.......... 71.163............... up to 20 years............ typically 5 years.
FSAR.............................. 71.177(a)(1) & (2)... yes....................... no.
Periodic Updates of FSAR.......... 71.177............... yes....................... n/a.
Maintain Record of Changes........ 71.175(d)............ yes....................... n/a.
Submit Reports of Changes & 71.175(d)(2)......... yes....................... n/a.
Summary of Evaluation.
OK for International ..................... no (not recognized under yes.
Transportation. IAEA regulations).
NRC Approval Needed for Changes in 71.167, yes....................... yes.
the Terms, Conditions, or 71.175(c)(1)(i).
Specifications in CoC.
Identify Potential Accidents that 71.153(b)(3), yes....................... no.
Will be Evaluated. 71.175(c)(2).
Provide Frequency of Occurrence of 71.175(c)(2)(i)...... yes....................... no.
an Accident.
Evaluate Consequence of an 71.175(c)(2)(iii).... yes....................... no.
Accident.
Evaluate Whether Changes Will 71.175(c)(2)(v)...... yes....................... no.
Create Possibility of an Accident
of Different Type.
Establish SSC Important to Safety. 71.175(a)(3)(i) & yes....................... no.
(ii).
Provide Probability of SSC 71.175(c)(2)(ii)..... yes....................... no.
Malfunction.
Evaluate Consequence of SSC 71.175(c)(2)(iv)..... yes....................... no.
Malfunction.
Evaluate Whether Changes Will 71.175(c)(2)(vi)..... yes....................... no.
Create Different Result of SSC
Malfunction.
Define Design Basis Limit for a 71.175(c)(2)(vii).... yes....................... no.
Fission Product Barrier.
Evaluate Whether Changes Will 71.175(c)(2)(vii).... yes....................... no.
Exceed Design Basis Limit for a
Fission Product Barrier.
Identify Method of Evaluation Used 71.175(a)(2)......... yes....................... no.
in Establishing the Design Basis.
Determine Whether Change is a 71.175(c)(2)(viii)... yes....................... no.
Departure From the Methods of
Evaluation Described in FSAR.
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Concerns With Implementation Identified by NRC Staff
Section 71.153(b) of the proposed rule states that an application
must include a safety analysis report describing an analysis of
potential accidents, package response to these potential accidents, and
any consequences to the public. This provision departs from the
standard part 71 package application (as described in Sec. 71.153(a))
in that an applicant must now assess potential accidents and their
consequences to the public from these accidents. Similar to part 72
accident analysis, the accidents to be evaluated could include natural
and man-made phenomena, but in the context of truck, rail, or vessel
transport activities. The types of information needed for the accident
analysis may include population densities by route; highway, vessel,
and railway accident rates; and cask and vehicle performance in
collisions and fires. This information may not be readily available,
and could require significant expenditures for both applicants to
produce this information and for NRC to develop guidance documents and
review the information. Consequences to the public may include
radiological and non-radiological consequences, and may include
environmental assessments of potential releases of radioactivity. In
addition, the information may require identification
[[Page 12090]]
of specific routes and modes of transport, unlike current package
approvals. It is noted that this information would be required in
addition to the package application described in Sec. 71.153(a).
Changes Currently Authorized Under Part 71
Coupled with these concerns, staff recognized that the regulatory
structure of part 71 already allows certain changes to the package
without prior NRC approval. For transportation packages, the NRC
approves the package design, and the Certificate of Compliance is the
approval document that specifies the design (including packaging and
radioactive contents) and package operations that are necessary for
safe transport. Typically the Certificate of Compliance includes these
essential elements: Specification of the design by reference to the
design drawings, specification of the authorized contents, and
reference to documents that relate to the use and maintenance of the
packaging and to the actions to be taken before shipment. These
drawings and documents identify the design and operational features
that are important for the safe performance of the package under normal
and accident conditions. Features that do not contribute to the ability
of the package to meet the performance standards in part 71 are not
necessarily included as conditions in the Certificate of Compliance. In
general, changes to the design or operations that are not conditions of
the Certificate of Compliance must be evaluated to assure that they do
not affect safety but do not require prior NRC approval.
The staff believes that many changes made to a dual purpose cask
under the provisions of 10 CFR 72.48, may also be made without prior
NRC approval in the current regulatory structure of part 71, without
explicit change authority. Changes to the conditions in the part 71
Certificate of Compliance would require prior NRC approval, even for
Type B(DP) packages. Therefore staff concluded that, considering the
development of the new information in a safety analysis report as
described in the proposed Sec. 71.153(b), and with the existing
ability to make certain changes to the package design and operation
without prior NRC approval, the benefits of implementation of the new
rule may not outweigh the costs.
Input Invited From Stakeholders
To assist staff in estimating the values and impacts of
implementation of the proposed rule, staff is inviting stakeholders to
provide certain information. Specifically, staff is seeking estimates
of the costs associated with development of a safety analysis report
evaluating potential accidents, package response, and consequences to
the public. Estimates are also needed with respect to the savings that
could result from exercising the change authority, for example, the
numbers and types of amendments that would not need to be prepared and
reviewed. A set of questions has been developed to guide stakeholders
in providing this information. The questions are listed in the
attachment to this paper. In addition, stakeholders may provide any
other relevant information that they believe could be useful in
providing staff with a factual basis for evaluating the values and
impacts of the proposed rule.
NRC staff is planning a workshop to be held on April 15, 2004, to
discuss the impact of the revised 10 CFR part 71. As part of the
workshop, the staff plans to hold a session devoted to the proposed
change authority rule. The staff plans to make a presentation that
explains the proposed rule and changes authorized under the current
part 71 regulations. Stakeholders are invited to participate by
providing the requested information in written form to be collected at
the workshop and in open workshop discussions.
Part 71 Change Authority Questions
To facilitate dialogue at the April 15, 2004, meeting, NRC staff
prepared the following questions. In addition, stakeholders are welcome
to provide written information to the contact above. Written
information is requested by April 30, 2004. Anything received after
that date will be considered only if practicable. NRC will consider
stakeholder comments in identifying a regulatory solution. NRC staff is
requesting fact-based input regarding the costs and benefits associated
with the proposed change authority. It is requested that the
information provided be as specific as practical, with identification
of actual experiences, if applicable.
Implementation of Proposed Change Authority Rule
How would Certificate Holders address the new requirements?
How would potential accident scenarios be developed?
How would accident frequencies be determined?
How would consequences be evaluated (address potential releases,
populations exposed, environmental pathways)?
How would modes of transport and transportation routes be
identified and considered in the accident and consequence analysis?
How would package suitability for a period of twenty years be
demonstrated?
How would structures, systems and components (SSCs) be determined
and identified in the final safety analysis report (FSAR)?
How would the probability of SSC malfunctions be determined?
How will the design basis limit for a fission product barrier be
defined?
How will the methods of evaluation used in the FSAR be determined
and identified?
How will the changes made under the proposed rules be tracked,
documented, and controlled?
Costs of the Proposed Change Authority Rule
What are the costs of developing an application containing the
requirements of 71.153?
What guidance documents would be needed from NRC?
What level of NRC staff review of the Type B(DP) package
application would be anticipated?
What are the costs in preparing FSAR updates, including the basis
for changes made under 71.175?
Benefits of the Proposed Rule
How many certificate amendments would be saved using the change
authority (quantify in terms of numbers and complexity)?
What operational or time savings would result from change
authority?
What other benefits are anticipated (quantify if possible), such as
cost of NRC review, minimizing regulatory uncertainty, schedule delay?
Changes Made Under Change Authority in 10 CFR 72.48 That Relate to Part
71
What is the stakeholder experience with actual changes made under
72.48 (numbers, types, complexity)?
How many of the changes made under 72.48 would require a
corresponding change to the part 71 Certificate of Compliance (numbers,
types, and complexity)?
What changes (types and number) that were made under 72.48 would
still require a part 71 Certificate amendment considering the ability
to use the proposed part 71 change authority?
Changes Desired Under Subpart I
Identify types of changes that are considered beneficial that would
fall under the change authority.
Dated at Rockville, Maryland, this 9th day of March 2004.
[[Page 12091]]
For the Nuclear Regulatory Commission.
David W. Pstrak,
Transportation and Storage Project Manager, Office of Nuclear Material
Safety and Safeguards.
[FR Doc. 04-5736 Filed 3-12-04; 8:45 am]
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