[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]

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.


Federal Register / Vol. 69, No. 50 / Monday, March 15, 2004 / 
Proposed Rules

[[Page 12088]]


10 CFR Part 71

Regulations for the Safe Transport of Radioactive Material; 
Public Meeting

AGENCY: Nuclear Regulatory Commission.

ACTION: Advance notice of public meeting.


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].



    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


    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
  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
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.
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.
Provide Probability of SSC          71.175(c)(2)(ii).....  yes.......................  no.
Evaluate Consequence of SSC         71.175(c)(2)(iv).....  yes.......................  no.
Evaluate Whether Changes Will       71.175(c)(2)(vi).....  yes.......................  no.
 Create Different Result of SSC
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.

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 
    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 
    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 
    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 

    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]