[Federal Register Volume 70, Number 2 (Tuesday, January 4, 2005)]
[Proposed Rules]
[Pages 312-317]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-25]


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 Proposed Rules
                                                 Federal Register
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 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. 70, No. 2 / Tuesday, January 4, 2005 / 
Proposed Rules  

[[Page 312]]



NUCLEAR REGULATORY COMMISSION

10 CFR Part 71

RIN 3150-AG71


Packaging and Transportation of Radioactive Material; Withdrawal 
of Subpart I

AGENCY: Nuclear Regulatory Commission.

ACTION: Proposed rule: withdrawal.

-----------------------------------------------------------------------

SUMMARY: The Nuclear Regulatory Commission (NRC) is withdrawing a 
portion of a proposed rule (Subpart I, April 30, 2002; 67 FR 21390) 
that would have allowed certificate holders for dual-purpose (storage 
and transport) spent fuel casks, designated as Type B(DP) packages, to 
make certain design changes to the transportation package without prior 
NRC approval. The NRC is taking this action because it has received 
significant comments regarding the cost and complexity to implement the 
proposed change authority rule.

FOR FURTHER INFORMATION CONTACT: Neelam Bhalla, Office of Nuclear 
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001, telephone (301) 415-6843, e-mail 
[email protected].

SUPPLEMENTARY INFORMATION:
    On April 30, 2002 (67 FR 21390), the NRC published in the Federal 
Register a proposed rule amending NRC's regulations on packaging and 
transporting radioactive materials to make the regulations compatible 
with the International Atomic Energy Agency (IAEA) standards. The 
proposed final rule also proposed changes in fissile material exemption 
requirements to address the unintended economic impact of NRC's 
emergency final rule entitled, ``Fissile Material Shipments and 
Exemptions'' and addressed a petition for rulemaking (PRM-73-12) 
submitted by International Energy Consultants, Inc. The Commission also 
identified eight additional issues for consideration in the 10 CFR Part 
71 rulemaking process. One of these NRC-initiated issues was Issue 15, 
adoption of change authority for dual-purpose package certificate 
holders. The proposed rule addressing this issue, 10 CFR Subpart I--
Application for Type B(DP) Package Approval, would have created a new 
type of package certification, Type B(DP). The proposed Subpart I would 
also have authorized holders of Type B(DP) certificates to make changes 
to the package design and procedures without NRC approval under certain 
conditions.
    NRC received substantial comments on the proposed rule, including 
numerous comments on the proposed Subpart I. The comments on the 
proposed Subpart I are presented below, with NRC's responses. On 
January 26, 2004 (69 FR 3698), the NRC published in the Federal 
Register a final rule amending 10 CFR Part 71. In that final rule, the 
Commission did not reach a final decision on the issue of change 
authority for dual-purpose package certificate holders. The NRC 
determined that implementation of the proposed change authority rule 
(Issue 15) could result in new regulatory burdens and significant 
costs, and that certain changes were already authorized under the 
current 10 CFR Part 71 regulations. The NRC further stated in the 
Federal Register that additional stakeholder input was needed on the 
values and impacts of the change authority rule before it could decide 
whether to adopt a final rule providing change authority. Subsequently, 
the NRC issued a discussion paper on March 15, 2004 (69 FR 12088), to 
facilitate discussions of the change authority rule and held a public 
workshop on April 15, 2004, with appropriate stakeholders to discuss 
the same proposed rule. The workshop transcripts are available on the 
NRC's public Web site at http://www.nrc.gov, under Current Rulemakings, 
Final Rules and Policy Statements, Compatibility with IAEA 
Transportation Safety Standards (TS-R-1) and Other Transportation 
Safety Amendments Rulemaking Text and Other Documents (RIN 3150-AG71).
    Information collected from the public workshop, as well as written 
comments received from the stakeholders, were generally against 
implementation of the change authority rule. The proposed 10 CFR 71.153 
of Subpart I would require the applicant for a Type B(DP) package to 
include two parts: (1) A current Part 71 application for a Type B(U) 
package; and (2) the additional information specifically required for 
the Type B(DP) packages, including, among other things, a safety 
analysis report (SAR) that provides an analysis of potential accidents, 
package response to these potential accidents, and consequences to the 
public.
    The major concern raised by the dual-purpose cask vendors and 
industry representatives is that the second SAR specified in the 
proposed Subpart I would impose a substantial cost and burden on them. 
Unlike current Part 71 standards for Type B(U) packages that are 
fundamentally route and mode independent, transport routes and 
population distributions might be needed for the second SAR in order to 
evaluate potential accidents, package response to these accidents, and 
consequences to the public. In addition, the accident analyses would be 
more complicated than the engineering examinations under the existing 
Part 71 hypothetical accident conditions. The dual-purpose cask vendors 
and industry representatives believe that it could require significant 
expenditures on the part of the applicant to produce such an SAR. In 
light of the public comments received, the Commission has reconsidered 
the need for the change authority provided in proposed Subpart I of the 
proposed rule and has determined to withdraw Subpart I of the proposed 
rule for the reasons explained below.
    The current Part 71 licensing process provides a framework that 
allows licensees flexibility to make certain non-safety related changes 
without prior NRC approval. The licensee can maximize such flexibility 
by writing Safety Analysis Reports that focus on the design features 
necessary to meet the regulatory requirements of Part 71. Typically, 
the NRC Certificate of Compliance (CoC) references design drawings, 
specification of the authorized contents, operating procedures, and 
maintenance commitments. 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. 
Therefore, the drawings and documents need to be of sufficient detail 
to identify the package accurately and to provide

[[Page 313]]

an adequate basis for its evaluation. However, when licensees include 
features that do not contribute to the ability of the package to meet 
the performance standards in Part 71 in drawings and documents, the 
licensees limit their flexibility to make changes without prior NRC 
approval. Furthermore, experience from the stakeholders has indicated 
that many changes made to a dual-purpose cask under the provisions of 
Sec.  72.48, may also be made without prior NRC approval in the current 
regulatory structure of Part 71, without explicit change authority.
    Implementation of the change authority in the proposed rule, on the 
other hand, would result in new regulatory burdens and significant 
costs for both stakeholders and NRC without a commensurate potential 
benefit. The proposed rule would require the applicant to: perform an 
independent analysis of potential transportation accidents specific to 
that design and plans for use; project package responses to ``real 
world'' transportation accidents; and determine the consequences to the 
public from such accidents. It would also require the applicant to 
perform a documented evaluation to demonstrate that ``changes'' would 
not result in the increase of frequency and consequences of potential 
``real world'' transportation accidents or the likelihood and 
consequences of a malfunction of structures, systems, and components 
(SSCs) important to safety; or raise the possibility of an unevaluated 
accident or malfunction. Consequently, the applicant would need 
information such as the transport routes and population distributions 
along the transportation routes on which a specific design is intended 
to be used. Since such information is not readily available, it could 
require significant expenditures and efforts on the part of the 
applicant to produce such information. Furthermore, as part of the 
implementation of the proposed Subpart I, NRC would have to expend 
significant resources to develop guidance documents on accident 
analyses, SSCs important to safety, the change process, and reviews of 
methodologies used in the design bases. Additionally, the staff 
resources needed to review an application under the proposed Subpart I 
would likely increase significantly with the need to perform reviews 
and document staff findings in the Safety Evaluation Report (SER) for 
these additional items.

Public Comments on the Change Authority of 10 CFR Part 71

Public Comments on the Proposed Rule, April 30, 2002. (Prior to the 
April 15, 2004 Meeting/Workshop)

Issue 15. Change Authority for Dual-Purpose Package Certificate Holders
    The following comments were submitted before the discussion paper 
that was issued on March 15, 2004 (69 FR 12088), and the public 
workshop that was held on April 15, 2004. Therefore, these commenters 
did not have the benefit of the additional information that was 
gathered in the discussion paper and the public workshop.
    Comment. One commenter opposed NRC's proposal to ``harmonize'' 
transport and storage of spent nuclear fuel and fissile materials with 
``a watered down international standard.'' The commenter said that the 
Type B(DP) package as proposed does not provide an adequate level of 
public protection from radiation hazards.
    Response. The NRC acknowledges the commenter's opposition to the 
proposed rule change. The NRC has decided to withdraw proposed Subpart 
I for the reasons explained above.
    Comment. An industry representative voiced support for the change 
authority that was included in the proposed rule. The commenter added 
that the quality assurance programs developed under Part 71 were 
equivalent in effectiveness and caliber to the programs developed under 
Part 72.
    Five commenters expressed their support for the NRC's proposal, but 
requested that the change authorization process be extended to all 
packages licensed under Part 71. Two of these commenters suggested 
reasons why licensees should be allowed to make minor changes 
independent of the CoC holders.
    Another commenter stated that the changes allowed for shipping 
packages licensed under Part 72 should also be allowed for those under 
Part 71.
    Response. As previously discussed, the proposed change is not being 
implemented for either dual purpose casks or for other transportation 
casks.
    Comment. Seven commenters expressed disapproval of the proposed 
change authority for dual purpose casks. One commenter stated that even 
``minor'' design changes made by licensees and shippers could impact 
the safety of casks and that all changes should be subject to full NRC 
review. One commenter suggested that there would not be sufficient 
experience based on the part of the CoC holders to implement the 
responsibility effectively, and another commenter suggested that the 
rule lacked specificity for adequate implementation and that the rule 
change would be more effective if each design change were subject to 
NRC independent inspection. One commenter asserted that the public has 
a right to know if design changes are being made.
    Response. The proposed change process is not being implemented for 
the reasons previously explained.
    Comment. One commenter expressed concern that transporting dual-
purpose containers is going to be complicated, especially in instances 
when there is no available rail access.
    Response. The NRC notes that this comment is beyond the scope of 
this rulemaking.
    Comment. Three commenters requested clarifications on various 
aspects of the proposed change authority. One of these commenters asked 
for clarification on what is meant by ``minimal changes'' with 
potential safety consequences. The commenter also asked that NRC 
include examples as well as seek, and consider, input from State 
regulatory agencies when amending certificates of compliance.
    Another commenter wanted to know if a certificate holder proposing 
a minor change would still have to check with the NRC to see if the 
change was permissible under the proposed change authority. The 
commenter wanted to know if NRC would be notified before the changes 
are made. The commenter requested clarification of the procedure for 
changes under the proposed change authority. The commenter also 
requested a more detailed explanation of what constitutes a minor 
design change with no safety significance.
    The last commenter wanted to know what types of changes could be 
made to dual-purpose spent nuclear fuel casks intended for domestic 
transport. This point was echoed by the first commenter who recommended 
that NRC establish guidance for determining when a design or procedural 
change that enhances one cask function might compromise the 
effectiveness of the other. NRC should ensure that the 
interrelationship between the storage and transportation effects of 
cask changes are considered during the review of certificate amendment 
requests. Furthermore, the first commenter stated that NRC should 
consider issuing a single certificate of compliance instead of two.
    Response. The proposed change process is not being implemented for 
the reasons previously explained.

[[Page 314]]

    Comment. One commenter noted that the eight criteria used to 
determine if changes require NRC prior approval were extracted verbatim 
from Parts 50 and 72 and placed into Part 71. The commenter suggested 
that these criteria be customized before inclusion in Part 71.
    Response. The eight criteria used to determine if changes require 
prior NRC approval are effectively the same as those included in Parts 
50 and 72. This motivated the staff to reevaluate how the proposed 
change process could be implemented and led to the determination that 
the proposed change process should not be added by this rulemaking as 
previously discussed.
    Comment. One commenter noted that a large number of highly 
radioactive shipments could take place in dual-purpose containers and 
that these shipments could be destined for a repository. The commenter 
explained that even minor design changes would affect waste acceptance 
at the repository.
    Response. This comment deals with detailed transportation and 
storage plans/designs that will need to be developed by the U.S. 
Department of Energy (DOE) in its effort to design, construct, and 
operate a proposed high level waste repository site and is beyond the 
scope of this rulemaking.
    Comment. One commenter expressed support for the design change 
authority being provided to CoC holders but recommended that the 
ability to make changes to the transportation design aspects of a dual-
purpose package be provided to licensees who use the casks as well. The 
basis for this recommendation is that the change process included in 
Part 72 for storage facilities or casks allows licensees to make 
changes to the storage design without prior NRC approval subject to 
certain codified tests. Another commenter was concerned that the 
proposed revisions to change authority would hinder the ability of Part 
72 general and specific licensees to effectively manage and control 
their Dry Cask Storage Program and ensure that changes made in 
accordance with Part 72 do not impact the Part 71 certification of 
spent fuel casks.
    Response. The proposed change process is not being implemented for 
the reasons previously explained.
    Comment. Three commenters expressed support for the proposed change 
authority. One of these commenters asserted that allowing the change 
authority would allow for more attention to more significant safety 
issues.
    Response. These three commenters did not provide a basis for their 
support of the proposed rule. The comments did not have the benefit of 
the additional information in the discussion paper that clarified NRC's 
view on the proposed rule and the April 15, 2004 workshop discussions. 
Although these three comments were in support of the proposed change 
authority, there were also significant concerns raised as indicated in 
response to other comments. The NRC staff considered all the comments 
and for the reasons described above, NRC determined that the proposed 
change process should not be implemented in this rulemaking. The NRC 
does not agree that the proposed change authority would have resulted 
in more attention to significant safety issues because even if this 
proposal were finalized, the existing standards of Part 71 would still 
have been required to be demonstrated.
    Comment. Two commenters suggested improvements on the procedures of 
the change authority. One stated that the two-year submittal date for 
application renewal is too long and instead suggested a 30-day 
requirement. The other commenter stated that the proposed Sec.  
71.175(d) change reporting requirements need to allow for a single 
report to be filed by dual-purpose CoC holders to comply with the 
requirements of Parts 71 and 72, to avoid unnecessary duplication of 
reports. Both stated that the proposed submittal date of two years 
before expiration for the renewal of a CoC or QA program is burdensome 
and should have a submittal date of only 30 days before expiration, as 
is required under Part 72. One commenter suggested that a CoC holder 
should be permitted to submit [change process implementation summary] 
report for both Part 71 and Part 72 designs as one package instead of 
having to provide two separate reports.
    Response. The NRC has chosen not to include the proposed change 
process in the final rule for the reasons previously explained.
    Comment. One commenter discussed 71/72 SAR's (Safety Analysis 
Reports) for the change authority. The commenter stated that a single 
71/72 SAR for generally certified dual-purpose systems should also be 
permitted as an option for CoC holders. The commenter suggested that 
the rule language should include provisions for submitting updated 
transportation Final Safety Analysis Reports (FSARs) for casks already 
certified and having an approved SAR. The commenter suggested that an 
FSAR Rev. 0 be submitted to replace the last approved transportation 
SAR within two years of the effective date of the final rule, 
consistent with the proposed Sec.  71.177(c)(6). The commenter stated 
that the requirement in proposed Sec.  71.177(c)(7) for an FSAR update 
to be submitted within 90 days of issuance of an amendment of the CoC 
is unnecessary and inconsistent with the requirements under Part 72 for 
the dual-purpose spent fuel storage casks. The commenter stated that 
this creates an unnecessary administrative burden on CoC holders by 
requiring extra FSAR updates. The commenter said that this portion of 
the proposed rule should be deleted.
    Response. Regarding the suggestion to permit the submittal of a 
single SAR for reflecting both the transportation and storage design 
for a dual-purpose cask, the NRC staff notes that the SAR submittal 
request is now moot based on the final rule language.
    The NRC staff notes that because Subpart I is being eliminated from 
the final rulemaking, the comment regarding the addition of a provision 
in the rule language for submittal of SAR updates for those 
transportation casks already certified is not applicable.
    The last comment regarding the requirement for the submittal of an 
updated FSAR within 90 days of an amendment to the transportation 
certificate of compliance is not applicable.
    Comment. One commenter expressed a number of concerns about the 
proposed change process for dual purpose casks. The commenter 
questioned the NRC position that the change process be implemented by 
the CoC holder while the licensee would be most familiar with details 
such as site-specific parameters affecting preparation, loading, and 
shipment of Type B(DP) packages. The commenter also noted that it has 
been unable to convince NRC that the level of required detail in the 
FSAR is excessive and would, therefore, require excessive evaluations 
with procedure changes that could only be addressed by the CoC holder 
rather than the licensee who is implementing detailed procedures. The 
commenter added that industry experience with storage procedures 
clearly demonstrates that the proposed limitation on procedure 
evaluation against the Part 71 FSAR by the licensee is unworkable.
    Response. The proposed change process is not being implemented for 
the reasons previously explained.

[[Page 315]]

Public Comments from Meeting/Workshop April 15, 2004

    Comment. One commenter noted that changes can be made under the 
current Part 71, without coming to the NRC for approval if the changes 
do not affect the drawings and contents listed in the certificate. 
Consequently, the commenter suggested that making intelligent SAR 
drawings and operations chapters appears to be a much better path for 
going forward than the proposed change authority of Part 71. The 
commenter also noted that the change authority for Type B(DP) packages 
included in the proposed Subpart I would add a substantial amount of 
work to a cask designer and license holder without a commensurate 
potential benefit. The commenter pointed out that many users of Part 72 
products wait until the last minute to buy their products and are under 
the gun to get them loaded. Furthermore, Part 72 amendment is a 
rulemaking process that takes a long time. Therefore, change authority 
is essential for Part 72. The commenter suggested that time is not an 
issue with Part 71 changes at the present time, or in the near future, 
because of the lack of activities in spent fuel transportation. Thus, 
there is time to deal with any discrepancies in the transport 
certificates that the licensees pick up either in the course of design 
changes or manufacturing.
    Response. NRC acknowledges the commenter's opinion about the 
proposed change authority of Part 71 which provides support for the 
NRC's decision to withdraw the proposed Subpart I.
    Comment. Four commenters voiced their support for the concept of 
change authority. Two commenters suggested that the change 
authorization process be extended to all packages licensed under Part 
71. One commenter, who is an industry representative, suggested that 
the change authority should be based on existing Part 71 criteria 
rather than on a new supplemental set of Part 71 criteria. In a 
subsequent letter, dated April 30, 2004, the industry representative 
informed NRC that the industry does not endorse NRC's proposed change 
process for Part 71 because the limited change ability, and the 
required additional FSAR, as included in the proposed Subpart I, would 
add significant cost and very little benefit to the industry. The 
industry representative encouraged NRC to develop a change process for 
Part 71 that is based on the existing regulatory safety criteria of 
Part 71 and offered to work with NRC cooperatively, for such an effort.
    Response. NRC acknowledges the commenter's support for the concept 
of change authority; however, the proposed change process is not being 
implemented as described above either for dual-purpose casks or for 
other transportation casks.
    Comment. One commenter voiced support for the cask-specific, mode-
specific, and route-specific approach to safety analysis included in 
the proposed Subpart I. The commenter noted that the analysis is 
presently one-sided, for dual-purpose casks, because licensees are 
required to consider all potential accidents and their consequences for 
storage; however, the likelihood and consequences are not considered 
for transportation. The commenter viewed the proposed Subpart I, Sec.  
71.153, which requires a probabilistic risk analysis for 
transportation, to be the instrument to correct this imbalance. The 
commenter suggested that this approach would not only be extremely 
useful for emergency planning purposes, but also would be helpful in 
avoiding populated areas, tunnels, high bridges, routes with high 
accident rates, etc., or to demonstrate that dual-purpose casks can 
withstand potential accidents along these routes. The commenter further 
suggested that dual-purpose casks certified as a result of this 
approach would greatly enhance public confidence in the nuclear 
industry which, in turn, would also benefit the DOE as the owners and/
or shippers of these casks to Yucca Mountain.
    Response. NRC acknowledges the commenter's support for the proposed 
change authority of Part 71 and understands that an independent 
accident analysis specific to designs could have public-confidence 
benefits. However, NRC disagrees with the commenter that the analysis 
is one-sided for dual-purpose casks. Dual-purpose casks must also meet 
performance requirements specified in Part 71 for packaging and 
transportation of radioactive material. Among the performance 
requirements, dual-purpose casks must be capable of withstanding the 
mechanical and thermal loading imposed by normal and accident 
conditions and still meet specified acceptance criteria. These 
conditions have been internationally accepted and have been shown to 
encompass spent fuel casks performance in severe accidents. The safety 
record associated with Part 71 for the domestic transportation of spent 
fuel is exemplary--approximately 1,300 shipments of civilian fuel and 
920,000 miles without an accidental radioactive release. Nonetheless, 
NRC continually examines the transportation safety programs. 
Furthermore, the Type B(DP) package approval in the proposed rule 
presented only an option for transportation. That is, other Type B 
packages would still be permitted for spent fuel transportation, and 
those packages would not require the mode and route specific accident 
analysis in proposed Subpart I. As for comments regarding emergency 
planning and avoiding populated areas, tunnels, high bridges, routes 
with high accident rates, etc., the U.S. Department of Transportation 
(DOT) regulates routing for hazardous material transportation, 
including radioactive materials.
    Comment. One commenter requested that the decision for the final 
rule regarding Part 71 change authority for dual-purpose package 
certificate holders be delayed for a period of six to nine months. The 
commenter cited the likely influences, regarding the cask selection 
choices, by: (1) The DOE Yucca Mountain transportation plan; (2) final 
status of the license for the Private Fuel Storage facility in Utah; 
and (3) the staff recommendations regarding the NRC package performance 
study (PPS), as reasons for the request.
    Response. NRC acknowledges the request for delaying the final rule 
regarding the change authority of Part 71; however, potential cask 
selection choices would not impact the Commission's decision to 
withdraw the proposed rule.
    Comment. One commenter wanted to know if all dual-purpose casks 
have to have a Type B(DP) approval, or whether they still can get a 
Type B(U) approval? The commenter also wanted to know if someone does 
get a Type B(DP) approval, could another person with basically the same 
design get a Type B(U) approval?
    Response. No responses to the commenters questions are needed given 
NRC's decision to withdraw the Type B(DP) approval process.
    Comment. Two commenters noted that there is a great deal of 
flexibility in the current Part 71 and wondered if NRC is planning to 
put out additional guidance to alert the designers to the flexibility 
that is available.
    Response. NRC acknowledges the commenters' recommendation regarding 
the current flexibility in Part 71 and agrees with the potential 
benefit of guidance on flexibility and making changes for Type B 
packages under Part 71. NRC understands that it would be helpful to 
describe and articulate the way that applications should be prepared to 
allow this flexibility. This includes identifying areas of flexibility,

[[Page 316]]

the kinds of things that are flexible, where we have seen problems, and 
where there are areas of over-commitment in the applications. Although 
no decision has been made on the method of communication to be used to 
inform the stakeholders about the flexibility that is currently 
available under Part 71, the staff would like to point out that several 
existing documents provide some of this guidance. Regulatory Guide 7.9, 
``Standard Format and Content of Part 71 Applications for Approval of 
Packaging for Radioactive Material,'' NUREG/CR-5502, ``Engineering 
Drawings for 10 CFR Part 71 Package Approvals,'' and NUREG/CR-4775, 
``Guide for Preparing Operating Procedures for Shipping Packages,'' are 
three examples that provide guidelines for preparing applications for 
package approval under the current Part 71.
    Comment. One commenter expressed concern that having to do a second 
safety analysis report, as proposed in Subpart I, to set up a whole set 
of criteria and identify another set of accident scenarios, 
probabilities, and consequence analyses, etc., is going to be very 
burdensome on the front end. The commenter cautioned that a lot more 
questions will be raised, rather than answered, if the industry goes 
down the path of having everyone develop their own accident scenarios, 
probabilities, and consequence assessments. The commenter suggested 
that the cost associated with doing a second SAR may be more expensive 
than doing an SAR under the current Part 71, because the regulations 
under the current Part 71 are very well defined and the industry knows 
exactly what it has to address. The commenter further suggested that it 
will take a lot of license amendments, under the current Part 71, to 
get a payback on the additional cost for second SAR approval.
    Response. NRC acknowledges the commenter's information about 
potential burdens and costs that the proposed rule could impose on 
stakeholders.
    Comment. One commenter suggested that the change authority included 
in the proposed Subpart I would not benefit existing packages; however, 
it might benefit new applications because they can build in enough 
flexibility in the drawings of the new applications. The commenter also 
called for an industry forum to develop a set of accident scenarios 
that will be binding for everybody.
    Response. The NRC has decided to withdraw the proposed rule for the 
reasons previously explained.
    Comment. Two commenters noted that, based on their respective 
experience in Part 72, the percentage of changes made, under Sec.  
72.48, that require a corresponding change to the Part 71 Certificate 
of Compliance, will be very low.
    Response. NRC acknowledges the commenter's experience about changes 
that were made, under Sec.  72.48, for dual-purpose casks, that would 
still require a Part 71 Certificate amendment.
    Comment. One commenter wanted to know whether changes can be made, 
under the regular Part 71 approval, without coming to NRC for 
amendments, if the same changes were first made under the change 
authority of Part 71, for Type (DP) packages.
    Response. This comment is now moot, given NRC's decision to 
withdraw the proposed Subpart I.
    Comment. One commenter used an example of minor design change to 
illustrate what would happen under the current Part 71 and what it 
might look like under the proposed Subpart I. Based on the scenario 
discussed, the commenter predicted that no one will be using the 
proposed Subpart I because a minor design change does not appear be a 
particularly time-consuming or costly operation under the current Part 
71, as compared to the proposed Subpart I.
    Response. NRC acknowledges the comparison about making design 
changes under the current Part 71, and the proposed Subpart I.
    Comment. One commenter suggested that a well developed full-scale 
cask testing program would address cask performance issues and 
eliminates the need to do a very detailed SAR, as proposed in Subpart 
I.
    Response. NRC acknowledges the recommendation of using full-scale 
tests for certification, however, Part 71 does not require full-scale 
tests for certification. It is the applicant's decision as to whether 
to use full-scale tests, scale model tests, or analyses, for 
certification. Therefore, this comment is beyond the scope of this 
rulemaking.
    Comment. One commenter wanted to know whether separate certificates 
are required for a common design with different sizes and weights.
    Response. Under the current Part 71, variations in design like that 
are handled under a single certificate. They would be evaluated by 
looking at bounding configurations.
    Comment. Four commenters suggested that the proposed Subpart I will 
not work unless NRC were to provide detailed guidance, developed in 
consultation with affected stakeholders, on the methods, data, and 
assumptions to be used in such safety analyses. NRC should not expect 
individual applicants to have to take that responsibility. One 
commenter suggested the NRC Modal Study and another suggested NUREG/CR 
6672, ``Reexamination of Spent Fuel Shipment Risk Estimates,'' as good 
representative models of the types of accident analyses that the 
applicants may want to consider. One commenter cautioned that the 
standardized accident analysis may not be applicable to an applicant 
who only uses casks for localized shipments.
    Response. NRC understands that it is ineffective, inefficient, and 
possibly confusing to have many different groups and entities creating 
accident analyses, predicting transport accident probabilities for 
individual designs. This supports NRC's decision to withdraw the 
proposed Subpart I.
    Comment. Two commenters noted that the change authority would not 
benefit them during the next few years because the spent fuel 
transportation program is not active at the present time nor expected 
to be, in the near future. Consequently, most of the current Part 71 
amendment requests, rather than dealing with design changes, are 
dealing with upgrade contents and adding contents to the existing 
packages, which would not be benefitted by the change authority.
    Response. NRC acknowledges the commenter's opinion that the 
proposed change authority of Subpart I lacked near-term benefit.
    Comment. One commenter, associated with several utilities that 
store fuel in dry casks at this time, expressed disapproval of paying 
for the implementation of the change authority without seeing any 
benefit to the utilities. The same commenter also questioned about 
paying for the implementation of the change authority while the benefit 
goes to the public relations for Yucca Mountain Project, as suggested 
by another commenter.
    Response. No response to the commenter is needed, given NRC's 
decision to withdraw the proposed Subpart I.
    Comment. One commenter noted that the greatest cost for preparation 
of a SAR associated with the proposed Subpart I would likely occur for 
the first cask analyzed under the new requirements. The commenter 
suggested that such cost might appropriately be borne by NRC as part of 
the PPS. The commenter also suggested that, for those casks to be used 
for shipments to Yucca Mountain, the cost might appropriately be borne 
by DOE.
    Response. No response to the commenter is needed, given NRC's

[[Page 317]]

decision to withdraw the proposed Subpart I.

    Dated at Rockville, Maryland, this 28th day of December, 2004.

    For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary of the Commission.
[FR Doc. 05-25 Filed 1-3-05; 8:45 am]
BILLING CODE 7590-01-P