Compatibility With IAEA Transportation Safety Standards (TS-R-1) and Other Transportation Safety Amendments

NUCLEAR REGULATORY COMMISSION

10 CFR Part 71

RIN 3150-AG71

Compatibility With IAEA Transportation Safety Standards (TS-R-1) and Other Transportation Safety Amendments

AGENCY:

Nuclear Regulatory Commission.

ACTION:

Proposed rule.

SUMMARY:

The Nuclear Regulatory Commission (NRC) is proposing to amend its regulations on packaging and transporting radioactive material to make them compatible with the International Atomic Energy Agency (IAEA) standards and to codify other applicable requirements. These changes would be compatible with ST-1 (TS-R-1), the latest revision of the IAEA transportation standards. This rulemaking would also address the unintended economic impact of NRC's emergency final rule entitled “Fissile Material Shipments and Exemptions” (February 10, 1997; 62 FR 5907) and a petition for rulemaking submitted by International Energy Consultants, Inc. (PRM-71-12: February 19, 1998; 63 FR 8362).

DATES:

The comment period closes July 29, 2002. Comments received after this date will be considered if it is practical to do so, but the Commission is able to assure consideration only for comments received on or before this date.

ADDRESSES:

Submit comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. Attention: Rulemaking and Adjudications Staff.

Deliver comments to 11555 Rockville Pike, Rockville, Maryland, between 7:30 a.m. and 4:15 p.m. on Federal workdays.

You may also provide electronic comments via the NRC's interactive rulemaking website at

http://ruleforum.llnl.gov.

This site provides the capability to upload comments as files (any format), if your web browser supports that function. For information about the interactive rulemaking website, contact Ms. Carol Gallagher at (301) 415-5905 (e-mail: CAG@nrc.gov).

Documents related to this action may be examined at the NRC Public Document Room (PDR) located at One White Flint North, 11555 Rockville Pike, Room O-1F23, Rockville, MD. Documents created or received at the NRC after November 1, 1999, are also available electronically at the NRC's Public Electronic Reading Room on the Internet at

http://www.nrc.gov/reading-rm/adams.html.

From this site, the public can gain entry into the NRC's Agencywide Documents Access and Management System (ADAMS), which provides text and image files of NRC's public documents. For more information, contact the NRC PDR Reference staff at 1-800-397-4209, 301-415-4737, or email to

pdr@nrc.gov.

FOR FURTHER INFORMATION CONTACT:

Naiem S. Tanious, Office of Nuclear Material Safety and Safeguards, USNRC, Washington, DC 20555-0001, telephone: (301) 415-6103; e-mail;

nst@nrc.gov.

SUPPLEMENTARY INFORMATION:

Contents

I. Background

II. Summary of Public Comments

III. Request for Cost-Benefit and Exposure Information

IV. Discussion

A. TS-R-1 Compatibility Issues

Issue 1: Changing Part 71 to the International System of Units (SI) Only

Issue 2: Radionuclide Exemption Values

Issue 3: Revision of A

1

and A

2

Issue 4: Uranium Hexafluoride Package Requirements

Issue 5: Introduction of the Criticality Safety Index Requirements

Issue 6: Type C Packages and Low Dispersible Material

Issue 7: Deep Immersion Test

Issue 8: Grandfathering Previously Approved Packages

Issue 9: Changes to Various Definitions

Issue 10: Crush Test for Fissile Material Package Design

Issue 11: Fissile Material Package Design for Transport by Aircraft

B. NRC-Initiated Issues

Issue 12: Special Package Authorizations

Issue 13: Expansion of Part 71 Quality Assurance Requirements to Certificate of Compliance (CoC) Holders

Issue 14: Adoption of American Society of Mechanical Engineers (ASME) Code

Issue 15: Change Authority for Dual-Purpose Package Certificate Holders

Issue 16: Fissile Material Exemptions and General License Provisions

Issue 17: Double Containment of Plutonium (PRM-71-12)

Issue 18: Contamination Limits as Applied to Spent Fuel and High-Level Waste (HLW) Packages

Issue 19: Modifications of Event Reporting Requirements

V. Section-By-Section Analysis

VI. Criminal Penalties

VII. Issues of Compatibility for Agreement States

VIII. Plain Language

IX. Voluntary Consensus Standards

X. Environmental Assessment: Finding of No Significant Impact

XI. Paperwork Reduction Act Statement

XII. Regulatory Analysis

XIII.Regulatory Flexibility Act Certification

XIV. Backfit Analysis

I. Background

The Commission directed the NRC staff in Staff Requirements Memorandum (SRM) 00-0117 dated June 28, 2000: (1) To use an enhanced public-participation process (website and facilitated public meetings) to solicit public input on the part 71 rulemaking; and (2) to publish the staff's Part 71 issues paper in the

Federal Register

(65 FR 44360; July 17, 2000) for public comment. The issues paper presented the NRC's plan to revise Part 71 and provided a summary of all changes being considered, both IAEA-related changes and NRC-initiated changes. The NRC published the issues paper to begin an enhanced public-participation process designed to solicit public input on the part 71 rulemaking. This process included establishing an interactive website and holding three facilitated public meetings: a “roundtable” workshop at the NRC Headquarters, Rockville, MD, on August 10, 2000, and two “townhall” meetings—one in Atlanta, GA, on September 20, 2000, and a second in Oakland, CA, on September 26, 2000.

SRM-00-0117 also directed the staff to proceed, after completion of the public meetings, with the development of a proposed rule for submittal to the Commission by March 1, 2001. Oral and written comments received from the public meetings, by mail, and through the NRC website, in response to the issues paper, were considered in the drafting of the proposed changes contained herein.

Past NRC-IAEA Compatibility Revisions

Recognizing that its international regulations for the safe transportation of radioactive material should be revised from time to time to reflect knowledge gained in scientific and technical advances and accumulated experience, IAEA invited Member States (the U.S. is a Member State) to submit comments and suggest changes to the regulations in 1969. As a result of this initiative, the IAEA issued revised regulations in 1973 (Regulations for the Safe Transport of Radioactive Material, 1973 edition, Safety Series No. 6). The IAEA also decided to periodically review its transportation regulations, at intervals of about 10 years, to ensure that the regulations are kept current. In 1979, a review of IAEA's transportation regulations was initiated that resulted in the publication of revised regulations in 1985 (Regulations for the Safe Transport of Radioactive Material, 1985 edition, Safety Series No. 6).

The NRC also periodically revises its regulations for the safe transportation of

radioactive material to make them compatible with those of the IAEA. On August 5, 1983 (48 FR 35600), the NRC published in the

Federal Register

a final revision to part 71, “Packaging and Transportation of Radioactive Material.” That revision, in combination with a parallel revision of the hazardous materials transportation regulations of the U.S. Department of Transportation (DOT), brought U.S. domestic transport regulations into general accord with the 1973 edition of IAEA transport regulations. The last revision to Part 71 was published on September 28, 1995 (60 FR 50248), to make part 71 compatible with the 1985 IAEA Safety Series No. 6. The DOT published its corresponding revision to Title 49 on the same date (60 FR 50291).

The last revision to the IAEA Safety Series 6 was named Safety Standards Series ST-1, published in December 1996, and was revised with minor editorial changes in June 2000, and was redesignated as TS-R-1. This rulemaking effort is to evaluate TS-R-1 for potential adoption in Part 71 regulations.

Historically, the NRC coordinated its Part 71 revisions with DOT, because DOT is the U.S. Competent Authority for transportation of hazardous materials. “Radioactive Materials” is a subset of “Hazardous Materials” in Title 49 regulations under DOT authority. Currently, DOT and NRC co-regulate transport of nuclear material in the United States. NRC is continuing with its coordinating effort with the DOT in this rulemaking process. Refer to the DOT's corresponding rule for additional background on the positions proposed in this notice.

Scope of 10 CFR Part 71 Rulemaking

As directed by the Commission, NRC staff compared TS-R-1 to the previous version of Safety Series No. 6 to identify changes made in TS-R-1, and then identified affected sections of Part 71. Based on this comparison, NRC staff identified 11 areas in part 71 that needed to be addressed in this rulemaking process as a result of the changes to the IAEA regulations. The staff grouped the part 71 IAEA compatibility changes into the following issues: (1) Changing part 71 to the International System of Units (Sl) (also known as the metric system) exclusively; (2) Radionuclide specific exemption values; (3) Revision of A

1

and A

2

values; (4) Uranium hexafluoride (UF

6

) package requirements; (5) Introduction of criticality safety index requirements; (6) Type C packages and low dispersible material; (7) Deep immersion test; (8) Grandfathering previously approved packages; (9) Adding and modifying Part 71 definitions; (10) Crush test for fissile material package design; and (11) Fissile material package design for transport by aircraft.

Eight additional NRC-initiated issues (numbers 12 through 19) were identified by Commission direction, and through staff consideration, for incorporation in the Part 71 rulemaking process. These NRC-initiated changes are: (12) Special package approvals; (13) Expansion of Part 71 quality assurance (QA) requirements to holders of, and applicants for, a Certificate of Compliance (CoC); (14) Adoption of the requirements of American Society of Mechanical Engineers (ASME), Boiler and Pressure Vessel (B&PV) Code for fabrication of spent fuel transportation packages; (15) Adoption of change authority; (16) Revisions to the fissile-exempt and general license provisions to address the unintended economic impact of the emergency rule (SRM-SECY-99-200); (17) Decision on Petition for Rulemaking PRM-71-12, which requested deletion of the double containment requirements for plutonium; (18) Surface contamination limits as applied to spent fuel and high-level waste packages (SRM-SECY-00-0117); and (19) Part 71 event reporting requirements. NRC published the first 18 issues in an issues paper in the

Federal Register

on July 17, 2000 (65 FR 44360).

The Part 71 rulemaking is being coordinated with DOT to ensure that consistent regulatory standards are maintained between NRC and DOT radioactive material transportation regulations, and to ensure coordinated publication of the final rules by both agencies. On December 28, 1999 (64 FR 72633), DOT published an advance notice of proposed rulemaking regarding adoption of TS-R-1 in its regulations.

II. Summary of Public Comments

The NRC held three public meetings to discuss and hear public comments on the issues under consideration for this rule. These meetings were transcribed by a court reporter; the meeting transcripts and condensed summaries of the comments made in the meeting are available to the public on the NRC's interactive rulemaking website at

http:/ruleforum.llnl.gov

and the Public Document Room located at One White Flint North, 11555 Rockville Pike, Room O-1F23, Rockville, MD. Also, the NRC received a total of 48 written comments on the issues paper during the meetings, by mail, and through the website. All of these written comments have been placed on the NRC website. The Commission has prepared a comment summary document entitled: “Summary and Categorization of Public Comments on the Major Revision of 10 CFR Part 71.” This document is published as NUREG/CR-6712, March 2001.

This section provides a summary of general comments received at the public meetings that are not associated with any one issue, but rather with the NRC rulemaking process for this effort of the Part 71 revision. A summary of public comments associated with a specific issue is included later in the discussion section under that issue. Comments not specific to this rulemaking effort are not included, nor are they discussed for their relevancy to the scope of this proposed action.

August 10, 2000, Meeting

Two commenters supported moving towards risk-informed regulation because they believe it will increase the safety of nuclear power plants by allowing the operators to focus on risk-significant issues.

Ten commenters wanted assurance that any changes to the NRC's regulations, whether in the context of conformity with international regulations, or solely affecting domestic shipments of radioactive materials, will not result in a reduction in transportation safety for the public.

Two commenters suggested that NRC provide more information about the specific changes that will be incorporated into a proposed rule. One of these commenters also suggested that NRC consider increasing the number of public meetings and having them early on in the process in locations that will potentially be affected by any changes in the transportation regulations. The commenter also requested that the public comment period for this proposed rule be extended. This commenter also suggested that possibly by coordinating public meetings for all rulemakings or actions related to transportation (e.g., the Package Performance Study), the public will be better able to see the interrelation of the various NRC actions.

Two commenters voiced their concern about the public accessibility of documentation related to transportation regulations. Specifically, they were concerned about the legal implications (i.e., due process) of not providing access to documents such as: (1) TS-R-1, (2) draft Advisory Material for the Regulations for the Safe Transport of Radioactive Material (TS-G-1.1) (supporting document for TS-R-1), and (3) the ASME code, while requesting public input on potential changes to the regulations to enhance conformity with

international and domestic standards and regulations. One commenter noted that without these materials, the underlying basis of a proposed rule cannot be fully explored before its incorporation into the regulations.

Two commenters were seeking clarification on the scope of the proposed changes. The commenters asked whether NRC intends to adopt all of the changes from IAEA's Safety Series 6 regulations that have been incorporated into the current TS-R-1 regulations, or just those identified in the proposed rule. One commenter also sought clarification as to whether the combined regulatory changes anticipated by NRC and DOT would cover all of the changes present in IAEA's TS-R-1 regulations.

Three commenters expressed concern over the possibility that the proposed changes in the transportation regulations could result in materials (including certain bulk materials) that were previously not regulated by NRC suddenly coming under NRC's jurisdiction, or actually becoming exempt in other jurisdictions. One commenter noted that this increased regulation could result in unnecessary concern on the part of the public as to the nature of the materials being transported. One commenter asked specifically if NRC was intending to start regulating naturally-occurring radioactive materials (NORM) and requested clarification on NRC's statutory authority to do so.

One commenter suggested that, in addition to NRC and DOT, State agencies play an important role in the regulation of radioactive materials. The commenter noted that currently 32 States have entered into agreements with the NRC to become Agreement States. As Agreement States, they regulate use of radioactive material, and have regulations on transportation of radioactive material, including enforcement authority. The commenter is interested in being able to track possible changes in current regulations and how this could affect regulations at the State level.

Seven commenters were concerned about the harmonization of NRC's regulations with those of the IAEA. The commenters expressed concern over the value of harmonization compared to the costs of implementation, and they further questioned the magnitude of the safety benefits of such harmonization. One commenter questioned that if Member States were not adopting TS-R-1 uniformly, what impact could that have on licensee's ability to transport internationally. Two commenters noted that while the TS-R-1 standards are burdensome, NRC does not want to stop commerce, and that is a risk if NRC does not adopt or harmonize with the TS-R-1 standards.

Another commenter noted that the U.S. should have the right to adopt more stringent standards than those contained in TS-R-1. This commenter argued that uniform regulations should constitute a “minimum” set of requirements and should not be considered the highest standard that should be applicable.

One commenter suggested that NRC and DOT consider adopting a set of guiding principles to assure that harmonization is done in the best interest of public health and safety.

Another commenter suggested that NRC adopt the IAEA regulations using a similar philosophy as is currently used by NRC, that is, by doing a safety check and ensuring that the level of safety is not diminished.

Two commenters were seeking clarification on the authority of the international organizations over the activities of the U.S. The commenters suggested that if these organizations are directly influencing what U.S. regulatory agencies do, then the public has the right to more knowledge about their activities. One commenter suggested that any activity to harmonize international regulations with those of the U.S. should be done in open, accountable, democratic forums.

September 20, 2000, Meeting

Several commenters were frustrated with the rulemaking process. These commenters indicated that a lack of easy access to pertinent resources, including TS-R-1 and relevant sections of the regulations, made it difficult to understand the nature, need, and potential impacts of the proposed changes. These commenters suggested that NRC seek alternative publication methods for relevant documents, such as posting the documents on the NRC website.

Six commenters stated that NRC should only suggest changing existing standards if these changes improve or otherwise strengthen existing standards. Two commenters stated that attempting to affect any other change—i.e., not increasing the protection of public health and safety and the environment—is not worth its regulatory costs. However, if NRC is going to pursue these changes, then NRC should weigh heavily potential public and environmental costs. These commenters stated that while NRC is moving towards increased globalization, international standards should be considered a regulatory floor and not a ceiling. One commenter specifically cited that NRC should strengthen “double-casking requirements.”

Three commenters stated that the proposed changes should not be allowed because they would increase public exposure rates without adequately informing the public of any risks associated with the increase. These commenters acknowledged the existence of background exposure rates, but believed that NRC needs to fully inform the public before changing current standards.

Four commenters expressed an interest in better understanding the transportation process and the security arrangements associated with the proposed changes. One commenter specifically requested an explanation to what links existed between this rulemaking process and the NRC, the DOT, and the Department of Energy's (DOE's) currently scheduled shipments of radioactive materials. Another commenter requested an explanation on what security arrangements exist and what preparations NRC and DOT have made to deal with accidents and other such security breaches.

One commenter suggested that the regulatory process be made as open and democratic as possible. This includes ensuring that supporting documents are not too expensive for the public to purchase, or otherwise access. Another commenter suggested that NRC hold additional public meetings to increase public involvement.

September 26, 2000, Meeting

One commenter expressed his appreciation for the NRC using an enhanced rulemaking process and encouraged the NRC to continue using this process.

Three commenters requested an extension of the public comment period to allow for additional public meetings. One commenter suggested that NRC hold not only additional public meetings, but also representative group sessions where Agreement States' representatives from affected cities, citizens' groups, and industry representatives discuss “the substantive issues that are implicated by ST-1.”

One commenter wanted to ensure that DOT and NRC have a process where NRC would jointly study and, after a reconciliation process, be able to address public comments in a coordinated fashion.

Two commenters found it difficult to clearly identify what changes were being proposed. They requested additional details on the proposed changes and encouraged NRC to define all of the terms and provide background information in the next iteration.

Specifically, they requested information that would enable the public to understand and evaluate the context and rationale for the proposed actions.

Two commenters were concerned that NRC fully examine the impacts of the proposed changes on DOE as well as other Federal agencies, such as the U.S. Environmental Protection Agency (EPA). One of the commenters stated that, to date, he has not seen any such detailed analysis, an analysis the commenter requested at an earlier time. The commenter stated that when NRC has previously relaxed its standards, DOE has followed suit and cited the example of transportation standards.

One commenter stated that NRC should view IAEA standards as minimum, not maximum, thresholds. The commenter requested that when NRC's regulations are more stringent than similar IAEA regulations, we retain that stringency. The commenter stated that he does not want NRC to lower its standards, and would prefer that international standards be raised.

Comments Received on the Website and by Mail

Several commenters indicated the importance of adopting uniform regulations by all countries to ensure safe and uninterrupted transportation of radioactive materials internationally. The commenters indicated that the IAEA serves a vital role in developing regulations governing the international shipment of radioactive materials, and without this guidance, each country would develop its own regulations, thus making compatibility difficult, if not impossible, to achieve. These commenters strongly urged the NRC and DOT to make every effort to harmonize Part 71 with TS-R-1 regulations, as is reasonably achievable.

Several commenters indicated that the public was not involved in the process that developed the TS-R-1 requirements. As a result, there is no objective analysis available for the public to determine which requirements are appropriate to change, and which ones are not.

One commenter suggested that rather than NRC developing parallel regulations with DOT, NRC's regulations should only address those areas under NRC responsibility, such as fissile material and Type B shipments.

Several commenters indicated that NRC must involve interested members of the public, State and local governments, and Tribes in a much broader framework in conjunction with the issuance of the proposed rule. One commenter argued that based on attendance at the public meetings, public participation has been inadequate and not representative. Another commenter noted that the public meetings were scheduled too close to the end of the public comment period, and that any meetings or hearings in conjunction with the proposed rule should be staged early in the comment process.

One commenter suggested that the issues paper did not contain sufficient detail indicating the NRC's positions with respect to each of the issues. The commenter stated that inclusion of this information, including any regulatory drivers, would be helpful in furthering the public's understanding of the basis of these proposed changes, most specifically with respect to adoption of TS-R-1 requirements.

One commenter raised the concern that the issues paper was not uniformly clear as to whether a proposed change would strengthen or weaken the protection of public health and safety in the U.S.

One commenter was concerned that the proposal to harmonize NRC's regulations with international standards does not take into account the special nature of transportation in the U.S. For example, the commenter noted that a significant portion of the transportation occurs over distances exceeding 2,400 miles and often in rural areas, where emergency responders are volunteers with limited training. The commenter stated that regulations should be developed to protect emergency responders and other personnel who could be expected to be in contact with radioactive materials shipments.

Several commenters requested an extension of the public comment period for the issues paper. The commenters cited several examples of why an extension is necessary, including impeded access to relevant information, periods of time during which the PDR was not open to the public, and closure of the Bibliographic Retrieval System for a period of 5 days.

One commenter indicated that over the last several years, the majority of NRC rulemaking initiatives appear to be largely driven by concerns in providing regulatory relief for industry rather than in increasing safety for the public.

One commenter claimed that IAEA standards are colored by consideration of commercial purposes. The commenter requested that NRC set aside commercial considerations in reviewing possible adoption of IAEA standards as NRC is first responsible to the American public and not to the international or domestic nuclear industry.

Two commenters questioned whether NRC would take into account advances in science and engineering and accumulated experience since the development of the IAEA regulations 6 years ago. If not, one commenter argued that the proposed revisions to Part 71 could be outdated before they are issued.

One commenter requested that TS-R-1 be made available for review to fully judge the impact that the proposed changes may have on transportation programs. For example, the commenter noted that one proposed change would result in different shipping names, without specifying those changes.

One commenter suggested that NRC adopt a Transportation Safety Goal documenting the acceptable risk for the transportation of radioactive material.

The public comments were considered in drafting the proposed requirements for 18 of the 19 issues (Issue 19 was added after publication of the issues paper). More details are provided under each issue.

NRC has made copies of publicly released documents available on the website at

http://www.nrc.gov/waste/spent-fuel-transp.html

. Furthermore, the NRC plans to conduct additional public meetings during the proposed rule comment period. The dates and locations of these meetings will be noticed separately.

III. Request for Cost-Benefit and Exposure Information

The NRC staff reviewed all public comments before drafting the proposed requirements in this notice. Summaries of all verbal, written, and electronic comments can be found in NUREG/CR-6712, Summary and Categorization of Public Comments on the Major Revision of 10 CFR Part 71, March 2001). The staff also prepared a draft Regulatory Analysis (draft RA) to assess the economic impact of the proposed requirements. The draft RA is also published for public comment (for announcement, see Section XII).

The NRC staff, as directed by the Commission, is continuing to solicit cost-benefit and exposure data from the public and industry to quantify the impact of the proposed Part 71 amendments. The NRC believes that this data will assist the Commission in: (1) Making an informed decision regarding the proposed IAEA compatibility changes, and (2) avoiding the promulgation of amendments that may result in unforeseen and unintended negative impacts, especially in view of the fact that the current regulations in Part 71 have provided adequate protection of the public health and safety.

To help focus the public and industry and to capture the most data, the following request for information is presented in three groups: (1) General requests that apply to all 19 issues, (2) requests that apply only to the IAEA-related changes, and (3) issue-specific staff questions.

Request for Information on All 19 Issues

The Commission is inviting comments from all stakeholders (Agreement States, public interest groups, and industry representatives) to address the overall impact of this proposed rule. Specifically, the Commission is soliciting: (1) Quantitative information and data on the costs and benefits which might occur if these proposed changes were adopted; (2) operational data on radiation exposures (increased or reduced) that might result from implementing the Part 71 proposed changes; (3) whether the proposed changes are adequate to protect public health and safety; (4) whether other changes should be considered, including providing cost-benefit and exposure data for these suggested changes; and (5) how should specific risk considerations (i.e., data on what can happen, how likely is it, what are the consequences) be factored into the proposed amendments.

Request for Information on the IAEA-Related Issues (Issues 1-11)

The NRC recognizes the importance, from an international commerce standpoint, of having the packaging and transportation regulations in Part 71 compatible with the IAEA's TS-R-1. However, before adoption, the NRC seeks to quantify the impact of adopting these IAEA regulations. Development of the IAEA TS-R-1 did not directly involve the public or include a cost-benefit analysis. In contrast, NRC's practice is to consider costs and benefits in its regulatory analysis, and NRC is prepared to differ from the TS-R-1 standards, at least for domestic purposes, to the extent the standards cannot be justified from a cost-benefit perspective, especially given the current regulations in Part 71 have provided adequate protection of the public health and safety.

Therefore, the NRC is inviting public comments on the IAEA-related issues, Issues 1-11. Specifically, the Commission is soliciting cost-benefit data to quantify the economic impact of harmonizing with the 11 IAEA changes on the domestic commerce and international commerce of packages containing radioactive material. The NRC is interested in determining: (1) whether the benefits of harmonization with the IAEA standards may exceed the costs, or may result in other health and safety problems resulting from dual standards between domestic (Part 71) and international (TS-R-1) requirements, and (2) whether the NRC should adopt only some of the 11 IAEA changes.

Request for Responses to Issue-Specific Questions:

Issue 2—Radionuclide Exemption Values

What impacts, if any, would result for industries that possess, use, or transport materials currently exempt from regulatory control (

e.g.,

unimportant source material under 10 CFR 40.13) if adoption of the radionuclide exemption values were to occur in Part 71?

What impacts, if any, would result for industries that transport natural material and ores containing naturally-occurring radionuclides which are not intended for processing for economic use of their isotopes (e.g., phosphate mining, waste products from the oil and gas industry), if the TS-R-1 exemption values are adopted, but without the “10 times the applicable exemption values” provision?

Another possible impact of the proposed radionuclide exemption values is in the area of waste disposal sites which are regulated by EPA under the Resource Conservation and Recovery Act (RCRA). The acceptance limit in these sites for materials containing radioactive residuals is the existing 70 Bq/g (0.002 μCi/g) standard used by DOT, NRC, and EPA. Presently, only the NRC and DOT are proposing to adopt the exemption values, which may result in situations where shipment of materials with residual radioactivity would be allowed for transportation under the new exemption values but would not be allowed for disposal in RCRA sites.

What cost impacts or other problems, if any, would result from adoption of the exemption values, in Part 71 and DOT regulations, for industries or entities involved in the shipment and disposal of materials with residual activity to RCRA sites?

Issue 3—Revision of A

1

and A

2

What impacts, if any, would result for the radiopharmaceutical industry in terms of cost and worker dose by adopting the lower international A

2

value, rather than retaining the current A

2

value for domestic shipment of molybdenum-99?

What impacts, if any, would result for industry in terms of cost and worker dose by retaining the current A

1

and A

2

values for californium-252, rather than adopting the international A

1

and A

2

values?

What impacts, if any, would result for industry in terms of cost and worker dose by not including in Table A-1 (A

1

and A

2

Values for Radionuclides) the 16 radionuclides that are listed in the current Part 71 but not in TS-R-1?

Issue 4—Uranium Hexafluoride UF

6

Package Requirements

Should the current practice of excluding moderators in criticality evaluations for UF

6

packages be continued?

Issue 5—Introduction of the Criticality Safety Index Requirements

What cost or benefit impacts would result if the per package Criticality Safety Index (CSI) were to change from 10 to 50?

Issue 6—Type C Packages and Low Dispersible Material

NRC requests information on the need for Type C packages, specifically on the number of package designs and the timing of future requests for Type C package design approvals.

Issue 8—Grandfathering Previously Approved Packages

Under what conditions should packagings be removed from service?

What are the cost or benefit impacts associated with the proposal to remove B( ) packages from service?

Issue 10—Crush Test for Fissile Material Package Design

What are the cost or benefit impacts of imposing the crush test requirement on fissile material package designs?

Issue 12—Special Package Approval

What additional limitations, if any, should apply to the conditions under which an applicant could apply for a package authorization?

Issue 17—Double Containment of Plutonium (PRM-71-12)

What cost or benefit impacts would arise from removal of the double containment requirement for plutonium?

Issue 18—Contamination Limits as Applied to Spent Fuel and High-Level Waste (HLW) Packages

NRC requests information regarding the application of the regulatory limits for removable contamination on the external surfaces of packages used for spent fuel shipments. This information will be most helpful if respondents also

indicate the cask design used and whether or not the cask is fitted with a protective cover prior to immersion in the spent fuel pool. Specifically, for previous spent fuel shipments, information is sought on:

(1) The removable contamination level on the cask surface after the cask has been loaded, removed from the spent fuel pool, and dried;

(2) The dose attributable to any decontamination efforts, including external dose from cask and facility radiation fields and internal dose from airborne radioactivity in the cask handling/loading areas;

(3) The removable contamination level on the cask surface after decontamination efforts and before shipment; and

(4) The removable contamination levels on the cask surface upon receipt at the destination facility.

IV. Discussion

This section is structured to present and discuss each issue separately (with cross references as appropriate). Each issue has four parts: Background, Discussion, NRC Proposed Position, and Affected Sections. The discussion section summarizes the public comments, NRC staff consideration of public comments and of technical and policy issues, and the regulatory analysis for that issue.

A. TS-R-1 Compatibility Issues

Issue 1. Changing Part 71 to the International System of Units (SI) Only

Background.

TS-R-1 uses the SI units exclusively. This change is stated in TS-R-1, Annex II, page 199: “This edition of the Regulations for the Safe Transport of Radioactive Material uses the International System of Units (SI).” The change to SI units exclusively is evident throughout TS-R-1. TS-R-1 also requires that activity values entered on shipping papers and displayed on package labels be expressed only in SI units (paragraphs 543 and 549). Safety Series No. 6 (TS-R-1's predecessor) used SI units as the primary controlling units, with subsidiary units in parentheses (Safety Series 6, Appendix II, page 97), and either units were permissible on labels and shipping papers (paragraphs 442 and 447).

The TS-R-1 change is in conflict with the NRC Metrication Policy issued on June 19, 1996 (61 FR 31169), which allows a dual-unit system to be used (SI units with customary units in parentheses). The NRC Metrication Policy was designed to allow market forces to determine the extent and timing for the use of the metric system of measurements. The NRC is committed, in that policy, to work with licensees and applicants and with national, international, professional, and industry standards-setting bodies [

e.g.,

American National Standards Institute (ANSI), American Society for Testing and Materials (ASTM), ASME] to ensure metric-compatible regulations and regulatory guidance. The NRC encouraged its licensees and applicants, through its Metrication Policy, to employ the metric system wherever and whenever its use is not potentially detrimental to public health and safety, or its use is economic. The NRC did not make metrication mandatory by rulemaking because no corresponding improvement in public health and safety would result, but rather, costs would be incurred without benefit. As a result, licensees and applicants use both metric and customary units of measurement.

According to the NRC's Metrication Policy, the following documents should be published in dual units (beginning January 7, 1993): new regulations, major amendments to existing regulations, regulatory guides, NUREG-series documents, policy statements, information notices, generic letters, bulletins, and all written communications directed to the public. Documents specific to a licensee, such as inspection reports and docketed material dealing with a particular licensee, will be issued in the system of units employed by the licensee.

Currently, Part 71 uses the dual-unit system in accordance with the NRC Metrication Policy.

Discussion.

Oral comments received at the public meetings, as well as written comments received on the issues paper, indicate opposition to the use of SI units only. Most commenters were opposed to switching to SI units only, and supported the continued use of the dual-unit system. At the August 10 meeting, a radiopharmaceutical industry representative commented that the Food and Drug Administration (FDA) requires the use of customary units (curie units), while shipping papers always list the activity in becquerels with curies in parentheses. The representative stated that while that presents some problems now, the industry is able to handle it. By moving to a system where the shipping papers are in SI units only, a situation would be created where the package contents are expressed in curies, while shipping papers and labels are expressed in becquerels. This could be confusing, especially when comparing the shipping papers to the contents. The implication is that this situation could create complications at the shipment destination as personnel would have to perform unit conversions to match package contents with the shipping papers. Furthermore, there was a concern that this could result in errors in patient administrations. Other commenters indicated that this change would result in significant costs for industry, with no apparent safety benefit.

Another commenter indicated that, although the U.S. has adopted a policy of shifting to SI units, this policy has not been implemented. Several commenters argued that requiring the use of SI units only for domestic shipments of radioactive materials, when the balance of the nation's activities are conducted in customary units, would cause confusion as well as possible safety issues if misunderstandings or miscalculations were to occur. The commenters noted that the majority of individuals (including emergency response workers) are more accustomed to using customary units, and by requiring the use of SI units, problems would occur in converting customary units to SI units. As a result, the commenters believed that this could result in an increased risk of inadvertent exposure of workers to radiation.

One commenter indicated that SI units are currently required to be used in certain cases for shipping and believed that such a change would pose little risk. However, the commenter added that any such change should be accompanied by a 3-year delay in the effective date to allow for proper transition.

NRC staff notes that the use of SI units only would conflict with the NRC's Metrication Policy, which allows the use of a dual-unit system for measurements. The statement made in NRC's final Metrication Policy, “* * * the NRC believed and continues to believe that if metrication were made mandatory by a rulemaking, no corresponding improvement in public health and safety would result but costs would be incurred without benefit,” still stands.

The NRC draft regulatory analysis (draft RA) indicates that maintaining the existing policy of allowing the use of dual units is appropriate from a safety, regulatory, and cost perspective. A change to require SI units only would necessitate an exemption by the Commission from its dual-units policy, and would result in an inconsistency between Part 71 and other parts of the Commission's regulations. Further, anticipated costs to industry for implementing the new requirement

(e.g., training, recalculations), estimated to be between $12.6 and $16.3 million, would be avoided if the dual-unit system is maintained. In addition, while NRC would incur $15,000 in costs by converting from one system of units to another, this cost is offset by a savings in resources for not proceeding with rulemaking activities to implement the change. As discussed by several commenters, the change to SI units only could result in the potential for adverse impact on the health and safety of workers and the general public as a result of unintended exposure in the event of shipping accidents, or medical dose errors, caused by confusion or erroneous conversion between the currently prevailing customary units and the new SI units by emergency responders or medical personnel.

The NRC considered the Commission policy on this issue, the above public comments, and the draft RA of the impact of this change, and concluded that adopting the IAEA use of SI units only in Part 71 would have both a cost impact and potentially negative impact on workers and public health and safety.

NRC Proposed Position.

The NRC does not intend to change Part 71 to use SI units only, nor does it intend to impose on Part 71 licensees, certificate holders, or applicants for a CoC the use of SI units only. While TS-R-1 uses SI units only, it does not specifically prohibit the use of a dual-unit system (SI units and customary units). Therefore, the NRC will continue to use the dual-unit system in Part 71.

Affected Sections.

None (not adopted).

Issue 2. Radionuclide Exemption Values

Background.

The DOT currently uses a specific activity threshold of 70 Bq/g (0.002 μCi/g) for defining a material as radioactive for transportation purposes. DOT regulations apply to all materials with specific activities that exceed this value. Materials are exempt from DOT's transportation regulations if the specific activity is equal to or below this value. The 70-Bq/g (0.002-μCi/g) specific activity value is applied collectively for all radionuclides present in a material.

Within § 71.10, the NRC uses the same specific activity threshold as a means of determining if a radioactive material is subject to the requirements of Part 71. Materials are exempt from the transportation requirements in Part 71 if the specific activity is equal to or below this value. Although the materials may be exempt from any additional transportation requirements under Part 71, the requirements for controlling the possession, use, and transfer of materials under Parts 30, 40, and 70 continue to apply, as appropriate, to the type, form, and quantity of material.

During the development of TS-R-1, it was recognized that there was no technical justification for the use of a single activity-based exemption 70-Bq/g (0.002-μCi/g) value for all radionuclides. It was concluded that a more rigorous technical approach would be to base radionuclide exemptions on a uniform dose basis, rather than a uniform specific activity (also known as activity concentration) basis.

By 1994, the IAEA and other international health-related organizations had developed the International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources, IAEA Safety Series No. 115. (This document is sometimes referred to informally as the Basic Safety Standards, or BSS.) During the preparation of this document, a set of principles had been developed and accepted for determining when exemption from regulation was appropriate. One of the exemption criteria was that the effective dose expected to be incurred by a member of the public from a practice (e.g., medical use of radiopharmaceuticals in nuclear medicine applications) or a source within a practice should be unlikely to exceed a value of 10 μSv (1 mrem) per year. IAEA Member State researchers developed a set of exposure scenarios and pathways which could result in exposure to workers and members of the public. These scenarios and pathways were used to calculate radionuclide exemption activity concentrations and exemption activities which would not exceed the recommended dose (see Safety Series No. 115, Schedule I, “Exemptions”).

To investigate the exemption issue from a transportation perspective during the development of TS-R-1, IAEA Member State researchers calculated the activity concentration and activity for each radionuclide that would result in a dose of 10 μSv (1 mrem) per year to transport workers under various BSS and transportation-specific scenarios. Due to differences in radionuclide radiation emissions, exposure pathways, etc., the resulting radionuclide-specific activity concentrations varied widely. The appropriate activity concentrations for some radionuclides were determined to be less than 70 Bq/g (0.002 μCi/g), while the activity concentrations for others were much greater. However, the calculated dose to transport workers that would result from repetitive transport of each radionuclide at its exempt activity concentration was the same [(10 μSv) (1 mrem)] per year. For the single activity-based value, the opposite was true, i.e., the exempt activity concentration was the same for all radionuclides (70 Bq/g) (0.002 μCi/g), but the resulting doses under the same transportation scenarios varied widely, with annual doses ranging from much less than 10 μSv (1 mrem) per year for some radionuclides to greater than 10 μSv (1 mrem) per year for others. The radionuclide-specific activity concentration values reduced the variability in doses that were likely to result from exempt transport activities.

IAEA noted that the exempt activity concentrations calculated for transportation scenarios were less than those found in Safety Series No. 115 (BSS), Table I-I, “EXEMPTION LEVELS: EXEMPT ACTIVITY CONCENTRATIONS AND EXEMPT ACTIVITIES OF RADIONUCLIDES (ROUNDED)”, but not by more than a factor of 100. IAEA did not believe the differences warranted a second set of exemption values, and therefore adopted the Safety Series No. 115 (BSS) values in TS-R-1. These values are found in TS-R-1, paragraphs 401-406, and in Tables I and II.

A consequence of using the BSS exemption values for transportation is that the estimated average annual dose under the transportation scenarios exceeds the 10 μSv (1 mrem) per year criterion for some radionuclides. The staff has estimated that the average annual dose per radionuclide under the transportation scenarios using the BSS exemption values for a representative list of 20 radionuclides is 0.25 mSv (25 mrem) per year. However, the staff estimates that the corresponding dose for the current 70 Bq/g (0.002 μCi/g) exemption value, using the same transportation scenarios and radionuclides, is approximately 0.5 mSv (50 mrem) per year. Although both the current exemption value and the BSS exemption values result in an estimated average dose per radionuclide that exceeds the criterion, the dose estimated for the BSS exemption values is significantly less than that estimated for the current 70 Bq/g (0.002 μCi/g) exemption value.

Note that some nuclides listed in Table I have a reference to footnote (b). These nuclides have the radiological contributions from their daughter products (progeny) already included in the listed value. For example, natural uranium [U (nat)] in Table I has a listed activity concentration for exempt material of 1 Bq/g (2.7 x 10-5 μCi/g). This means the activity concentration of the uranium is limited to 1 Bq/g (2.7 x 10-5 μCi/g), but the total activity

concentration of an exempt material containing 1 Bq/g (2.7 x 10-5 μCi/g) of uranium will be higher (approximately 7 Bq/g (1.9 x 10-4 μCi/g)) due to the radioactivity of the daughter products.

The basis for the exemption values, as discussed in the draft Advisory Material for the Regulations for the Safe Transport of Radioactive Material, TS-G-1.1, paragraphs 107.5 and 401.3, indicates that materials with very low hazards can be safely exempted from the transportation regulations. If the exemptions did not exist, enormous amounts of material with only slight radiological risks, materials which are not ordinarily considered to be radioactive, would be unnecessarily regulated during transport.

Based on TS-R-1, paragraph 236, when both the activity concentration for exempt material and the activity limit for an exempt consignment are exceeded, the material or consignment must meet applicable transportation regulations. Paragraph 404 of TS-R-1 specifies how exemption values may be determined for mixtures of radionuclides.

Some of the lower activity concentration values might include NORM. As an example, ores may contain NORM. In regard to transporting NORM, one petroleum industry representative stated there are no findings that indicate the current standard fails to protect the public, and that there is no benefit in making the threshold more stringent. Further, it would have a significant impact on their operations. Other similar comments were received during the public meetings. The overall impact would be that some material formerly not subject to the radioactive material transport regulations may need to be transported as radioactive material and therefore meet the corresponding applicable DOT transport requirements.

IAEA recognized that application of the activity concentration exemption values to natural materials and ores might result in unnecessary regulation of these shipments, and established a further exemption for certain types of these materials. Paragraph 107(e) of TS-R-1 further exempts: “natural material and ores containing naturally occurring radionuclides which are not intended to be processed for use of these radionuclides provided the activity concentration of the material does not exceed 10 times the values specified in paragraphs 401-406.”

Discussion.

Comments were received on this issue during the public meetings, by mail, and on the NRC web site. One commenter stated that the NRC should reference all DOT equivalent regulations (the radionuclide exemption values and all others) to prevent conflict between the NRC and DOT regulations. Two commenters cautioned that moving from one exemption value to different values for each radionuclide could result in more complicated compliance and enforcement scenarios. For example, one commenter indicated that the 70-Bq/g (0.002-μCi/g) exemption limit is also used as a standard by EPA under the RCRA as the permit limit for the acceptance of material containing radioactive residuals. Any changes to this limit could result in the preclusion of certain materials for disposal at permitted disposal facilities. Some commenters indicated that the revised exemption values should apply not only to domestic shipments but to exported shipments as well.

One commenter indicated that this change will have a significant unintended impact on its operations because most of the oil and gas shipments would not be exempt under the new rule.

One commenter indicated that such a change would result in an increase in the number of shipments by requiring smaller quantities to be shipped due to the lower exemption values. Another commenter suggested that the use of radionuclide-specific exemption values would not result in an increase in the number of packages being shipped, but would result in more shipments being labeled as radioactive. The commenter argued that because many of these shipments are currently being made as “nonhazardous” shipments, many of the responses to accidents will be for minimal hazard materials representing insignificant risks that do not warrant increased response safety. The commenter stated that this would not result in increased safety, but would instead divert emergency response personnel from other, more significant, tasks.

Several commenters reflected a belief that, for some radionuclides, the new higher values would be a relaxation of the regulations, and thus will adversely impact public health and safety. A few commenters indicated that NRC should actually look at making the exemption values more stringent rather than reducing the level of protection currently afforded the public. One commenter suggested that, before adopting any of the exemption values contained in TS-R-1, NRC should scrutinize the values to determine whether they are justified as protective of human health and the environment.

A few commenters supporting the retention of the current Part 71 exemption values indicated that a move to radionuclide-specific exemption values would result in increased costs while yielding no additional safety benefit.

The overall impact would be that some previously exempted material may need to be transported as radioactive material and therefore would need to meet applicable DOT transport requirements. While these activity concentration values would impact certain sectors, the NRC staff believes that the impact of not adopting the international standard would be significantly greater. Therefore, the NRC is proposing to adopt the radionuclide exemption values to assure continued consistency between domestic and international regulations.

In § 71.10(b)(3), the 0.74-TBq (20-Ci) exemption for special form americium and special form plutonium would be removed, except for

244

Pu. This provision was originally provided in Part 71 to permit the transportation, in domestic commerce within the United States, of well-logging sealed sources containing up to 0.74 TBq (20 Ci) of radioactive material in Type A packages, even though that quantity of special form americium or plutonium was greater than the individual A

1

limits for these radionuclides. However, over time, the A

1

limits have been raised so that currently only

244

Pu has an A

1

limit less than 0.74 TBq (20 Ci) (i.e., 0.4 TBq or 10.8 Ci). Consequently, this exemption is unnecessary for special form americium and special form plutonium, but is still needed for

244

Pu.

To prevent an unnecessary economic impact on industry, NRC staff believes the 0.74-TBq (20-Ci) exemption for special form

244

Pu, transported in domestic commerce, should be retained as a new § 71.14(b)(2). Furthermore, an exception would be added to § 71.14(b)(1) indicating that paragraph (b)(1) does not apply to special form

244

Pu transported in domestic commerce. This exception to the exemption would provide regulatory consistency between paragraphs (b)(1) and (b)(2), while permitting the continued transportation, within the U.S. only, of well-logging sources in a Type A package—when the source contains more than an A

1

quantity of

244

Pu, but less than 0.74 TBq (20 Ci). For international shipments, the A

1

quantity limit for special form

244

Pu would continue to apply.

The NRC would include the TS-R-1 exemption values in a new table in Appendix A (Table A-2). Additionally, NRC recognized that changes were also required to Appendix A. Specifically, changes would be needed to paragraph II to correct the following problems: (1)

The existing paragraph is not in plain language; (2) Guidance is needed on how to determine exempt material activity concentrations and exempt consignment activity limits for unlisted radionuclides; (3) The method of requesting Commission approval, if new Table A-3 is not used, needs to be specified; and (4) The existing requirement on requesting NRC prior approval is not listed in the approved Information collection requirements of § 71.6.

The NRC draft RA indicates that adopting the radionuclide-specific exemption values contained in TS-R-1 is appropriate from a safety, regulatory, and cost perspective. Adoption of these values would provide a consistent level of protection for all radionuclides and result in enhanced regulatory efficiency for the NRC and consistency among NRC, IAEA, and DOT. In addition, adoption would result in a single system for determining if materials are subject to domestic or international regulations (e.g., an imported package from England or France, which is exempt, would also be exempt in the United States). NRC believes that this increase in regulatory efficiency and potential cost savings, in some cases, more than offsets the potential increased costs to industry. These costs are anticipated to include minor administrative and procedural changes to use radionuclide-specific exemptions. Also, industry would expend resources to identify the radionuclides in a material, measure the activity concentration of each radionuclide, and apply the “mixture rule” to ensure that a material is exempt. This is in contrast to the current approach of verifying that the material's total concentration is less than 70 Bq/g (0.002 μCi/g). Further, because some low-level materials may be newly brought into the scope of the regulations, some additional costs may be incurred. However, NRC believes that these costs would be offset by the fact that some materials may be moved outside the scope of the regulations, resulting in a cost savings. Cost savings for shippers of low-level materials shipping both domestically and internationally would also be decreased because they would only have to ensure compliance with one set of requirements as opposed to two distinctly separate sets of requirements. Also, nonadoption of the TS-R-1 values could result in significant negative cost impacts on international commerce. Finally, NRC does not believe that adopting these values would have a significant effect on the total number of shipments domestically or internationally. The changes would also not significantly affect the way these materials are handled.

The NRC considered the above public comments and the draft RA of this change, and concluded that adopting the new IAEA, dose-based, exemption values would improve public health and safety by establishing a consistent dose-model application for minimizing potential dose to transport workers. Within the United States, DOT has the responsibility for regulating the classification of radioactive materials. DOT is also adopting the TS-R-1 exemption concentration activity and exempt consignment values, and the NRC is proposing to make conforming changes to Part 71. While these activity concentration values will impact certain sectors, the impact of not adopting the international standard would be significantly greater. By adopting the provision to allow natural material and ores containing NORM, which are not intended to be processed for the radionuclides, to have an activity 10 times the exemption value, the NRC believes that Part 71's impact on the mineral and petroleum industries will be minimized.

NRC Proposed Position.

The NRC is proposing to adopt the radionuclide exemption values in TS-R-1 to assure continued consistency between domestic and international regulations for the basic definition of radioactive material. This adoption into NRC regulations would not impact the Memorandum of Understanding (MOU) (July 2, 1979; 44 FR 38690) between DOT and NRC. The exemptions in existing § 71.10 would be revised to reflect the exempt concentration and exempt consignment values of Appendix A, Table A-2. In addition, provisions for 10 times applicable values would be included for NORM and other natural materials. These changes would conform this rule to DOT's proposed regulations.

Affected Sections.

§§ 71.10, 71.88, Appendix A.

Issue 3. Revision of A

1

and A

2

Background.

The international and domestic transportation regulations use established activity values to specify the amount of radioactive material that is permitted to be transported in a particular packaging and for other purposes. These values, known as the A

1

and A

2

values, indicate the maximum activity that is permitted to be transported in a Type A package. The A

1

values apply to special form radioactive material, and the A

2

values apply to normal form radioactive material. See § 71.4 for definitions.

In the case of a Type A package, the A

1

and A

2

values as stated in the regulations apply as package content limits. Additionally, fractions of these values can be used (e.g., 1x10

−

3

A

2

for a limited quantity of solid radioactive material in normal form), or multiples of these values (e.g., 3,000 A

2

to establish a highway route controlled quantity threshold value).

Based on the results from an updated Q-system (see TS-G-1.1, Appendix I), the IAEA has adopted new A

1

and A

2

values for radionuclides listed in TS-R-1 (see paragraph 201 and Table I). IAEA adopted these new values based on calculations which were performed using the latest dosimetric models recommended by the International Commission on Radiological Protection (ICRP) in Publication 60, “1990 Recommendations of the ICRP.” A thorough review of the Q-system also included incorporation of data from updated metabolic uptake studies. In addition, several refinements were introduced in the calculation of contributions to the effective dose from each of the pathways considered. The pathways themselves are the same ones considered in the 1985 version of the Q-system: external photon dose, external beta dose, inhalation dose, skin and ingestion dose from contamination, and dose from submersion in gaseous radionuclides. A thorough, up-to-date radiological assessment has been performed for each radionuclide of potential exposures to an individual should a Type A package of radioactive material be involved in an accident during transport. The new A

1

and A

2

values reflect that assessment.

While the dosimetric models and dose pathways within the Q-system were thoroughly reviewed and updated, the reference doses were unchanged. The reference doses are the dose values which are used to define a “not unacceptable” dose in the event of an accident. Consequently, while some revised A

1

and A

2

values are higher and some are lower, the potential dose following an accident is the same as with the previous A

1

and A

2

values. The revised dosimetric models are used internationally to calculate doses from individual radionuclides, and these refinements in the pathway calculations result in various changes to the A

1

and A

2

values. In other words, where an A

1

or A

2

value has increased, the potential dose is still the same—the use of the revised dosimetric models just shows that a higher activity of that radionuclide is actually required to produce the same reference dose. Conversely, where an A

1

or A

2

value has decreased, the revised models show that

less activity of that nuclide is needed to produce the reference dose.

Discussion.

Comments on the adoption of the new A

1

and A

2

values were received during the three public meetings and on the NRC website. One commenter stated that to conduct business internationally, there needs to be consistency between the international and domestic regulations. These commenters supported the adoption of the new values into Part 71. Other industry representatives, however, indicated the values should not change as they would need to modify the computer codes at their facility to maintain the ability to accurately meet the regulatory requirements for transportation. Other commenters were concerned about the safety aspects of transportation and the emergency responder's exposure if the new values should be adopted.

Additional comments were received concerning the A

1

and A

2

values for californium-252 and molybdenum-99, respectively. Currently, in Part 71, the A

1

for californium-252 is 0.1TBq (2.7 Ci). The A

1

value in TS-R-1 is 5.0x10

−

2

TBq (1.35 Ci). Both NRC and DOT have learned that IAEA is considering changing the A

1

value for californium-252 back to the value currently in 10 CFR Part 71 and 49 CFR in the next edition of TS-R-1. DOT is proposing to retain the current Part 71 A

1

value for californium-252 for domestic commerce. Therefore the NRC is planning to do the same as a conforming action with DOT.

Regarding molybdenum-99, comments were received from the radiopharmaceutical industry concerning the A

2

value. Currently in Part 71, the A

2

value for molybdenum-99 is 0.5 TBq (13.5 Ci). Further, in Appendix A, Table A-1, the A

2

value for molybdenum-99 has a footnote that indicates for domestic use, the A

2

value is 0.74 TBq (20 Ci). Pharmaceutical industry representatives indicated that a change to the TS-R-1 A

2

value of 0.6 TBq (16.2 Ci) for molybdenum-99 would result in a significant increase in the number of packages shipped and in occupational doses due to the lower A

2

value (16.2 Ci versus 20 Ci). DOT is proposing to retain the current exception for molybdenum-99 for domestic commerce, and NRC also believes the current exception for this radionuclide should be retained.

Several commenters opposed NRC's proposal to adopt the IAEA A

1

and A

2

values, arguing that any increase in allowable activity levels is unacceptable, could result in increased risk, and would violate the principle of maintaining safety. One commenter stated that the proposed adoption would change from an activity-based limit system to a dose-based limit system, which is unacceptable because dose-based limits are more difficult to verify and enforce than are activity-based limits.

Several commenters stated that NRC should provide a breakdown of which radionuclides would have increased activity levels, and which would remain the same, to allow for meaningful public comment on the proposed change.

Several commenters indicated that adoption of ICRP-60 into NRC regulations would result in another inconsistency within the regulations. Another commenter disagreed, arguing that NRC runs the risk of eroding public confidence in its regulatory role by accepting, then ignoring, the advice of international experts. The commenter argued that there should be a very strong justification if recommendations of the ICRP are to be discounted.

In general, the new A

1

and A

2

values are within a factor of about three of the earlier values; there are a few radionuclides where the new A

1

and A

2

values are outside this range. A few tens of radionuclides (out of more than 300) have new A

1

values higher than previous values by factors ranging between 10 and 100. This is due mainly to improved modeling for beta emitters. There are no new A

1

or A

2

values that are lower than the previous figures by more than a factor of 10. A few radionuclides previously listed are now excluded, but two additional ones have been added, both isomers of europium-150 and neptunium-236. Many A

1

and A

2

values remain unchanged.

The NRC staff review of TS-R-1 against the current Part 71 has identified 16 radionuclides that are listed in Table A-1 in Part 71 Appendix A, but which do not appear in TS-R-1. These are: Ar-42, Au-196, Es-253, Es-254, Es-254m, Es-255, Fm-255, Fm-257, Ho-163, Ir-193m, Nb-92m, Po-208, Po-209, Re-183, Te-118, and Tm-168. In an effort to maintain compatibility with TS-R-1, the NRC proposes not to include A

1

and A

2

values for these radionuclides in Table A-1. Licensees can use, without NRC approval, the general values for A

1

or A

2

in Table A-3 for individual radionuclides whose identities are known (such as the above 16), but which are not listed in Table A-1. Alternatively, licensees can obtain NRC approval for using specific values for those radionuclides. The NRC staff consulted with the DOT staff on this issue, and DOT is also proposing not to include A

1

and A

2

values for these radionuclides in its revised table of A

1

and A

2

values.

The A

1

and A

2

values were revised by IAEA based on refined modeling of possible doses from radionuclides. The NRC staff believes adoption of the IAEA standard would be an overall benefit to public and worker health and international commerce by ensuring that the A

1

and A

2

values are consistent within and between international and domestic transportation regulations.

The NRC draft RA indicates that adopting the new A

1

and A

2

activity limits specified in TS-R-1 is appropriate from a safety, regulatory, and cost perspective. Adoption of these values would result in enhanced regulatory efficiency for the NRC and consistency among NRC, IAEA, and DOT, especially in the handling of imports and exports. Adoption would result in a single set of values for determining the activity limits for specifying the amount of radioactive material permitted to be transported in a particular package for both domestic and international shipments. In some cases, NRC believes that this increase in regulatory efficiency and potential cost savings more than offsets the potential increased costs. These costs are anticipated to include revisions to shipping programs to implement the new values, modifications to shipping processes to assure compliance with the new values, and training. These costs, however, are expected to be minor because industry already has programs in place that use the A

1

and A

2

values. In addition, NRC would realize additional minor implementation costs in revising the values in Part 71. The NRC draft RA indicated no significant change in the number of shipments per year; therefore, accident frequency would not be affected.

NRC Proposed Position.

The NRC is proposing to make a conforming change to Part 71 to adopt the new A

1

and A

2

values from TS-R-1 in Part 71, with the differences as discussed for molybdenum-99 and californium-252. The NRC is also proposing not to include A

1

and A

2

values for the 16 radionuclides that are currently listed in Part 71, but which do not appear in TS-R-1 (see the Discussion section of Issue 3). This action would allow for continued consistency within and between international and domestic transportation regulations for radioactive materials. The DOT is also proposing to adopt the new TS-R-1 A

1

and A

2

values in its regulations, but without the 16 radionuclides cited above. NRC is requesting stakeholder input with regard to the changes focused around the A

1

and A

2

values for californium-252, molybdenum-99, and the 16 radionuclides that will be

removed from Table A-1. NRC is interested in learning what impacts these changes will have on industry.

Affected Sections.

Appendix A.

Issue 4. Uranium Hexafluoride Package Requirements

Background.

Requirements for uranium hexafluoride (UF

6

) packaging and transportation are found in both NRC and DOT regulations. The DOT regulations contain requirements that govern many aspects of UF

6

packaging and shipment preparation, including a requirement that the UF

6

material be packaged in cylinders that meet the ANSI N14.1 standard. NRC regulations address fissile materials and Type B packaging designs for all materials.

TS-R-1 contains detailed requirements for UF

6

packages designed for transport of more more than 0.1 kg UF

6

. First, TS-R-1 requires the use of the International Organization for Standardization (ISO) 7195, “Packaging of Uranium Hexafluoride for Transport.” Second, TS-R-1 requires that all packages containing more than 0.1 kg UF

6

must meet the “normal conditions of transport” drop test, a minimum internal pressure test, and the hypothetical accident condition thermal test (para 630). However, TS-R-1 does allow a competent national authority to waive certain design requirements, including the thermal test for packages designed to contain greater than 9,000 kg UF

6

, provided that multilateral approval is obtained. Third, TS-R-1 prohibits UF

6

packages from using pressure relief devices (para 631). Fourth, TS-R-1 includes a new exception for UF

6

packages regarding the evaluation of criticality safety of a single package. This new exception (para 677(b)) allows UF

6

packages to be evaluated for criticality safety without considering the inleakage of water into the containment system. Consequently, a single fissile UF

6

package does not have to be subcritical assuming that water leaks into the containment system. This provision only applies when there is no contact between the valve body and the cylinder body under accident tests, and the valve remains leak-tight, and when there are quality controls in the manufacture, maintenance, and repair of packagings coupled with tests to demonstrate closure of each package before each shipment.

Discussion.

One commenter indicated serious concerns about the safety margins for UF

6

packaging. The commenter cited the exception in TS-R-1, paragraph 677(b), which would allow UF

6

packages to be evaluated for criticality without considering the inleakage of water. The commenter cited a report describing one case where UF6 packages with manufacturing defects were used. The commenter indicated that it would be imprudent and unwise public policy to assume that water could not leak into a package containing UF

6

.

Another commenter stated that a justification for the reduced regulatory burden has not been established and cannot be done unless a risk study, which determines the level of conservatism currently contained in Part 71, is conducted. Without this analysis, the commenter argued, reduction of regulatory burden leading to inadvertent criticality could lead to loss of life, degradation of the environment, economic repercussions, and degradation of public confidence.

Also, comments at the public meetings supported the NRC view that ANSI N14.1 and ISO 7195 are equivalent. Further, other comments indicated that NRC-certified UF

6

packages already comply with TS-R-1 paragraphs 630 and 677(b).

The provisions of § 71.55(b) specify that a fissile material package must be designed, or the contents limited, so that a single package would be critically safe if water were to leak into the containment vessel. This is a design feature that assures criticality safety in transport, in the unanticipated event that water leaks into the containment vessel, and provides moderating materials for the fissile contents. The proposed new § 71.55(g) would except fissile UF

6

from the requirement that a single package must be critically safe with water inleakage. This is consistent with the worldwide practice in shipping fissile UF

6

and is consistent with ANSI N14.1 and ISO 7195 standards and DOT regulations.

The proposed rule language further restricts use of the exception to a maximum enrichment of 5 weight percent uranium-235. This is the maximum enrichment currently authorized in ANSI N14.1, ISO 7195, and DOT regulations in cylinders larger than 20.3 cm (8 inches) in diameter. For smaller cylinders, the exception is not needed because current enrichments are critically safe by geometry for a single package. The exception, with the enrichment limit, codifies current worldwide practice in shipping fissile uranium hexafluoride. Large quantities of enriched (greater than 5 weight percent uranium-235) UF

6

would require packages that meet the water inleakage standards in § 71.55(b). The staff believes that it is not prudent to expand this exception to include UF

6

shipments with higher uranium enrichments.

The NRC draft RA indicates that revising the current requirements for uranium hexafluoride packages to include an exception from the requirement that single packages must be critically safe from water inleakage is appropriate from a safety, regulatory, and cost perspective. In developing the draft RA, the NRC first determined that there are no substantial differences between ANSI N14.1 standard and ISO 7195 standard for UF

6

packaging, and therefore, there would be no significant cost impacts from this change, because NRC currently requires conformance with ANSI N14.1, but regulatory efficiency would be enhanced by making Part 71 compatible with TS-R-1. The internal pressure test and drop test requirements are currently met by existing package designs that comply with ANSI N14.1. Therefore, there would be limited impact on licensees by this aspect of the NRC action. The NRC staff also considered the United States' earlier opposition (Taylor, 1996) to this change, i.e., the IAEA adopting the UF

6

package requirements. Most of the impact of adopting the TS-R-1 UF

6

provisions would fall on the 30-inch and 48-inch bare cylinders that are within the purview of DOT and for which there is a “multilateral” approval option that could be used to mitigate most of this potential impact to licensees. Therefore, the adoption of the TS-R-1 requirements is not expected to have significant impact on fissile package designs for UF

6

. (Additional minor costs may be incurred for training for handling overpacks.) Because the changes are not expected to have significant impacts on current package designs, changes in environmental impacts are expected to be negligible.

NRC Proposed Position.

The NRC is proposing to adopt § 71.55(g) to address TS-R-1, paragraph 677(b), to exempt certain UF

6

packages from the requirements of § 71.55(b). The requirements in TS-R-1, paragraphs 629, 630, and 631, do not necessitate changes to Part 71 because NRC uses analogous national standards and addresses package design requirements in its design review process. All NRC-certified packages must be used in accordance with DOT requirements (including the UF

6

requirement in 49 CFR 173.420).

Affected Sections.

§ 71.55.

Issue 5. Introduction of the Criticality Safety Index Requirements

Background.

Historically, the IAEA and U.S. regulations (both NRC and DOT) have used a term known as the

Transport Index (TI) to determine appropriate safety requirements during transport. TI has been used to control the accumulation of packages for both radiological safety and criticality safety purposes and to specify minimum separation distances from persons (radiological safety). The TI has been a single number which is the larger of two values: the “TI for criticality control purposes”; and the “TI for radiation control purposes.” Taking the larger of the two values has ensured conservatism in limiting the accumulation of packages in conveyances and in-transit storage areas.

TS-R-1 (paragraph 218) has introduced the concept of a Criticality Safety Index (CSI) separate from the old TI. As a result, the TI was redefined in TS-R-1. The CSI is determined in the same way as the “TI for criticality control purposes,” but now it must be displayed on shipments of fissile material (paragraphs 544 and 545) using a new “fissile material” label. The redefined TI is determined in the same way as the “TI for radiation control purposes” and continues to be displayed on the traditional “radioactive material” label.

TS-R-1 (paragraph 530) also increased the allowable per package TI limit [for criticality control purposes (new CSI)] from 10 to 50 for nonexclusive use shipments. No change was made to the per package radiation TI limit of 10 for nonexclusive use shipments. As noted above, a consolidated radiation safety and criticality safety index existed in the past. In this consolidated index, the per package TI limit of 10 was historically based on concerns regarding the fogging of photographic film in transit, because film might also be present on a nonexclusive use conveyance. Consequently, when the single radiation and criticality safety indexes were split into the TI and CSI indexes, the IAEA determined that the CSI per package limit, for fissile material packages that are shipped on a nonexclusive use conveyance, could be raised from 10 to 50. The IAEA believed that limiting the total CSI to less than or equal to 50 in a nonexclusive use shipment provided sufficient safety margin, whether the shipment contains a single package or multiple packages. Therefore, the per package CSI limit, for nonexclusive use shipments, can be safely raised from 10 to 50, thereby providing additional flexibility to shippers. Additionally, no change was made to the per package CSI limit of 100 for exclusive use shipments.

Discussion.

Comments received on this proposal indicated that the industry supports the use of the new label “CSI” in conjunction with the “TI” labels, and stated that separate labels are more meaningful and provide additional safety in transport, as long as the two labels are distinctive, so as to avoid confusion.

In general, public comments received at the meetings supported the use of the CSI. One commenter believed that using the TI as the means to control criticality safety does not provide emergency responders with information on the undamaged condition of the package. Other commenters suggested that NRC should provide the underlying technical justification for the term “equivalent safety,” because otherwise, this change would seemingly allow for more packages in a single shipment. The use of CSI provides an equivalent level of safety to using a TI, because the CSI uses the same methodology (§ 71.59) that was used to calculate the criticality portion of the current TI.

One industry commenter disagreed that the CSI requirement is appropriate. The commenter stated that the TI already incorporates the more restrictive value and provides adequate protection. The commenter believed there is no increase in safety by adding this new requirement and, in fact, it would result in more opportunities for human error. Further, the commenter indicated that any benefit for adding the CSI is far outweighed by the additional labor, material, training, and administration costs that would be borne by a company that ships thousands of packages each year.

Increasing the CSI per package limit from 10 to 50 for nonexclusive use shipments was overlooked by NRC staff and was not discussed in the June 2000 Issues Paper or the associated public meetings. Consequently, no stakeholder input was obtained on this aspect of Issue 5 prior to developing the proposed rule.

The NRC draft RA indicates that introducing new CSI requirements into part 71 is appropriate from a safety, regulatory, and cost perspective. NRC would require that applicants for fissile material package design approvals clearly indicate the CSI value for the design. The CoCs the NRC issues for these designs would also need to clearly indicate the CSI value for authorized contents. The adoption of the CSI values would make part 71 consistent with TS-R-1, therefore enhancing regulatory efficiency.

The NRC staff believes that shipping fissile material packages on either an exclusive or nonexclusive use conveyance provides a reasonable assurance that public health and safety and the environment will be adequately protected. Furthermore, shipment on a nonexclusive use conveyance of a single package with a CSI equal to 50, a shipment of 5 packages each with a CSI equal to 10, or 20 packages each with a CSI equal to 2.5, are all safe and provide reasonable assurance of adequate protection. While NRC staff recognizes that the reactivity per package will increase with an increase in the CSI from 10 to 50, staff also believes the limit on the total CSI in a nonexclusive use shipment provides adequate protection against mishandling events. Accordingly, this change will not have a significant safety impact.

The total annual estimated cost of the new label to the nuclear power licensees and material licensees is approximately $1.4 million.

1

Some of these costs would be offset by the fact that for some shipments of fissile material packages, the accumulation of packages for criticality control purposes and the accumulation of packages (including minimum separation distances from persons) for radiological control purposes are shipped independently (the most restrictive criteria would not control the other as is the case with the current dual-use TI). Further, increased efficiency in shipping some fissile material packages could occur by avoiding the situation where separation distance requirements (radiological safety) unduly restrict package accumulation (criticality safety). From a health and safety perspective, emergency responders in accident circumstances (thus public health and safety) benefit from more clearly displayed information upon arrival at the accident scene.

1

This number is estimated by assuming 10 percent of the approximately 2.8 million total annual shipments (or 280,000) contain fissile material requiring lables indicating the CSI and TI. And of this 10 percent, NRC assumes five packages per shipment and $1 per package for labeling, thus arriving at the $1.4 million total annual licensee costs.

The NRC staff was unable to estimate the magnitude of the impact or cost savings that would arise to licensees due to the increase in the CSI per package limit. However, staff judged that cost savings could be realized because of increased licensee flexibility in shipping a larger number of fissile material packages on less expensive, nonexclusive use conveyances. Therefore, the NRC is requesting stakeholder input on the quantity of shipments in a typical year that would be affected by an increase in the per package CSI limit from 10 to 50 for nonexclusive use shipments and any associated cost savings. Because of lack

of data, the NRC is also requesting stakeholder input on the current number of fissile material shipments typically made per year (i.e., fissile-exempt, fissile general license, or Type A(F) or B(F) packages); the types of material shipped (e.g., waste, laboratory quantities, or production quantities); the shipment method used for these types of fissile material; and whether these are exclusive or nonexclusive use shipments.

NRC Proposed Position.

The NRC proposes to adopt the TS-R-1 (paragraph 218) which incorporates a CSI in Part 71 that would be determined in the same manner as the current Part 71 “TI for criticality control purposes.” The NRC also proposes to adopt TS-R-1 (paragraph 530) which increases the CSI per package limit from 10 to 50 for fissile material packages in nonexclusive use shipments. A TI will be determined in the same way as the “TI for radiation control purposes.” The NRC believes the differentiation between criticality control and radiation protection would better define the hazards associated with a given package and, therefore, provide better package hazard information to emergency responders. The increase in the per package CSI limit may provide additional flexibility to licensees by permitting the increased use of less-expensive, nonexclusive use shipments. However, licensees will still retain the flexibility to ship a larger number of packages of fissile material on an exclusive use conveyance.

Affected Sections.

§§ 71.4, 71.18, 71.20, 71.59.

Issue 6. Type C Packages and Low Dispersible Material

Background.

TS-R-1 has introduced two new concepts: the Type C package (paragraphs 230, 667-670, 730, 734-737) and the Low Dispersible Material (LDM). The Type C packages are designed to withstand severe accident conditions in air transport without loss of containment or significant increase in external radiation levels. The LDM has limited radiation hazard and low dispersibility; as such, it could continue to be transported by aircraft in Type B packages (i.e., LDM is excepted from the TS-R-1 Type C package requirements). U.S. regulations do not contain a Type C package or LDM category, but do have specific requirements for the air transport of plutonium (§§ 71.64 and 71.74). These specific NRC requirements for air transport of plutonium would continue to apply.

The Type C requirements apply to all radionuclides packaged for air transport that contain a total activity value above 3,000 A

1

or 100,000 A

2

, whichever is lesser, for special form material, or above 3,000 A

2

for all other radioactive material . Below these thresholds, Type B packages would be permitted to be used in air transport. The Type C package performance requirements are significantly more stringent than those for Type B packages. For example, a 90-meter per second (m/s) impact test is required instead of the 9-meter drop test. A 60-minute fire test is required instead of the 30-minute requirement for Type B packages. There are other additional tests, such as a puncture/tearing test, imposed for Type C packages. These stringent tests are expected to result in package designs that would survive more severe aircraft accidents than Type B package designs.

The LDM specification was added in TS-R-1 to account for radioactive materials (package contents) that have inherently limited dispersibility, solubility, and external radiation levels. The test requirements for LDM to demonstrate limited dispersibility and leachability are a subset of the Type C package requirements (90-m/s impact and 60-minute thermal test) with an added solubility test, and must be performed on the material without packaging for nonplutonium materials. The LDM must also have an external radiation level below 10 mSv/hr (1 rem/hr) at 3 meters. Specific acceptance criteria are established for evaluating the performance of the material during and after the tests (less than 100 A

2

in gaseous or particulate form of less than 100-micrometer aerodynamic equivalent diameter and less than 100 A

2

in solution). These stringent performance and acceptance requirements are intended to ensure that these materials can continue to be transported safely in Type B packages aboard aircraft.

In 1996, the NRC communicated to the IAEA that the NRC did not oppose the IAEA adoption of the newly created Type C packaging standards (letter dated May 31, 1996, from James M. Taylor, EDO, NRC, to A. Bishop, President, Atomic Energy Control Board, Ottawa, Canada). However, Mr. Taylor stated in the letter that to be consistent with U.S. law, any plutonium air transport to, within, or over the U.S. will be subject to the more rigorous U.S. packaging standards.

Discussion:

Comments from the public suggested that Type C standards might increase the number of shipments with smaller quantities of material using the same Type B containers to avoid the cost of developing Type C packages and to avoid the requirement of meeting the new Type C package standards. One commenter indicated that any proposal to change package design requirements should only be contemplated after a thorough technical review that has independently justified the change as protective.

However, one commenter stated that NRC should remove from its regulations the plutonium-specific requirements for air transport, and replace them with the Type C package requirements. Also, the commenter stated that because Type C package development would take a number of years, industry would work with the NRC to define tests, analyses, and criteria for demonstrating compliance with the Type C package standards.

One commenter questioned the rigorousness of the testing described in TS-R-1, indicating that the minimum acceptable impact speed should be increased to at least 129 m/s, as was mandated by Congress.

The staff evaluated the Type C package, and proposes that the NRC not adopt Type C or LDM requirements at this time. The bases for this staff proposal include: (1) IAEA development of aircraft accident severity information through a coordinated research project for further evaluation of the Type C and LDM requirements; (2) the fact that there are very few anticipated shipments affected by these requirements; (3) DOT rules that permit the use of IAEA standards in nonplutonium import/export shipments of foreign certified Type C containers, so that international commerce is not impacted; (4) NRC's domestic regulations currently in place (§§ 71.64 and 71.74), based on specific statutory mandates, governing air transport of plutonium (plutonium air transport was a considerable factor in IAEA adoption of Type C provisions); and (5) comments made by the public on the issues which generally disagreed with or questioned the rigor of the Type C tests, and supported NRC maintaining its current regulatory requirements for the safety of plutonium air shipments.

The DOT reviews the use of packages for import or export shipment. Consequently, foreign Type C packages could be approved by DOT for import and export only. The NRC does not believe that a Type C package is needed for domestic commerce; therefore, no provisions would be added to Part 71 relating to Type C packages. However, should DOT request that NRC perform a technical evaluation for a revalidation of a foreign Type C package design, NRC would evaluate the design against TS-R-1 Type C standards. Similarly, if requested by DOT, NRC would review a domestic Type C package design intended for use in international

commerce against TS-R-1, and provide NRC's recommendation to DOT. (Note that NRC revalidation of designs for DOT does not constitute NRC issuance of a CoC.)

The NRC draft RA indicates that not adopting the TS-R-1 Type C or LDM provisions in Part 71 is appropriate from a safety, regulatory, and cost standpoint. There may be some reduction in regulatory efficiency as a result of the nonadoption of the TS-R-1 requirements, which could result in NRC case-by-case reviews to support international shipments. NRC would continue to use its proven, safe regulatory requirements for air transport of plutonium. Further, NRC staff resources are conserved by nonadoption, and no additional costs would be incurred by industry. Any additional costs to industry would involve development costs for the design of new packages to meet the Type C requirements rather than using existing Type B packages.

NRC Proposed Position.

The NRC would not adopt Type C or LDM requirements at this time.

Affected Sections.

None (not adopted).

Issue 7. Deep Immersion Test

Background.

TS-R-1 expanded the performance requirement for the deep water immersion test (paragraphs 657 and 730) from the requirements in the IAEA Safety Series No. 6, 1985 edition. Previously, the deep immersion test was only required for packages of irradiated fuel exceeding 37 PBq (1,000,000 Ci). The deep immersion test requirement is found in Safety Series No. 6, paragraphs 550 and 630, and basically stated that the test specimen be immersed under a head of water of at least 200 meters (660 ft) for a period of not less than one hour, and that an external gauge pressure of at least 2 MPa (290 psi) shall be considered to meet these conditions. The TS-R-1 expanded immersion test requirement (now called enhanced immersion test) now applies to all Type B(U) [Unilateral] and B(M) [Multilateral] packages containing more than 10

5

A

2

, as well as Type C packages.

In its September 28, 1995 (60 FR 50248), rulemaking for Part 71 compatibility with the 1985 edition of Safety Series No. 6, the NRC addressed the new Safety Series No. 6 requirement for spent fuel packages by adding § 71.61, “Special requirements for irradiated nuclear fuel shipments.” Currently, § 71.61 is more conservative than Safety Series No. 6 with respect to irradiated fuel package design requirements. It requires that a package for irradiated nuclear fuel with activity greater than 37 PBq (10

6

Ci) must be designed so that its undamaged containment system can withstand an external water pressure of 2 MPa (290 psi) for a period of not less than one hour without collapse, buckling, or inleakage of water. The conservatism lies in the test criteria of no collapse, buckling, or inleakage as compared to the “no rupture” criteria found in Safety Series No. 6 and TS-R-1. The draft advisory document for TS-R-1 (TS-G-1.1, paragraphs 657.1 to 657.7) recognizes that leakage into the package and subsequent leakage from the package are possible while still meeting the IAEA requirement.

The Safety Series No. 6 test requirements were based on risk assessment studies that considered the possibility of a ship carrying packages of radioactive material sinking at various locations. The studies found that, in most cases, there would be negligible harm to the environment if a package were not recovered. However, should a large irradiated fuel package (or packages) be lost on the continental shelf, the studies indicated there could be some long term exposure to man through the food chain. The 200-meter (660-ft) depth specified in Safety Series No. 6 is equivalent to a pressure of 2 MPa (290 psi), and roughly corresponds to the continental shelf and to depths that the studies indicated radiological impacts could be important. Also, 200 meters (660 ft) was a depth at which recovery of a package would be possible, and salvage would be facilitated if the containment system did not rupture. (Reference Safety Series No. 7, paragraphs E-550.1 through E-550.3.)

The expansion in scope of the deep immersion test was due to the fact that radioactive materials, such as plutonium and high-level radioactive wastes, are increasingly being transported by sea in large quantities. The threshold defining a large quantity as a multiple of A

2

is considered to be a more appropriate criterion to cover all radioactive materials, and is based on a consideration of potential radiation exposure resulting from an accident.

Discussion.

Several comments received at the public meetings, as well as written comments received on the Issues Paper, indicated support for retaining the current, more stringent, requirements contained in § 71.61 with respect to not allowing collapse, buckling, or inleakage of water in the containment vessel. One commenter was concerned that the term “rupture” seemed less stringent than “collapse, buckling, or inleakage of water.” The commenter noted, however, that the issues paper does not include definitions for “rupture” or “buckling,” so it is difficult to know which term is more or less stringent. Another commenter believed that the proposed test requirement of withstanding underwater pressure for at least an hour is insufficient. The commenter explained that it is unrealistic to expect to recover nuclear materials from the water within 1 hour after a major accident.

One commenter questioned whether there was sufficient technical justification for relaxing the current NRC test criteria for packages of irradiated nuclear fuel. The commenter stated that a lot of environmental damage can occur before a rupture develops, and that the proposal does nothing to ensure that packages are as safe as they can be.

Another commenter noted that TS-R-1 refers only to normal form material for the immersion test. Specifically, the commenter asked what the criteria are for a special form A

1

quantity, and whether the deep immersion test was necessary for B(U) packages for special form materials. NRC reviewed the IAEA regulations and believes that this requirement applies to both normal form and special form material. Similarly, one commenter noted that, in practicality, the quantities listed would be limited to irradiated fuel elements, and that shipment of radioisotopes rarely contain these amounts. This commenter suggested that the present criteria be maintained and extended to cover all packages with activity levels greater than or equal to 10

5

A

2

quantities with the note that this is more conservative than TS-R-1 requirements. The commenter stated this should eliminate the requirement for special review and certification of U.S. origin package designs. For nonirradiated fuel element shipments, the commenter believed there should be no impact on availability and shipping costs because there are few shipments of the required quantities of this material. Finally, the commenter questioned whether, with the application to B(U) packages containing A

1

special form sources, these packages are exempt from this test.

In response to the question about how to address the differences in acceptance standards, two commenters stated that due to the international nature of transportation activities, U.S. transportation regulations should be consistent with IAEA transportation regulations and, therefore, NRC should adopt the TS-R-1 requirements for the enhanced deep immersion test.

Two commenters also addressed whether U.S. origin package designs

should be specifically reviewed and certified before shippers can export them. One commenter said that if the response is not specific to the deep immersion test, but applies to all package design criteria, then the shipment of U.S. certified package designs for import/export use beginning in mid-2001 is entirely dependent upon approval of these designs to TS-R-1 performance standards. The commenter believed that failure to grant U.S. Competent Authority certifications for these designs would seriously hinder the industrial radiography industry, and place U.S. package designers and manufacturers at a strong competitive disadvantage. The commenter added that several of its shipments were not acceptable in several countries when NRC and DOT failed to adopt Safety Series No. 6 in a timely manner.

Another commenter stated that NRC should clarify if previously approved packages would be grandfathered, or if they would have to be recertified by means of a deep immersion test.

The NRC proposes revising Part 71 requiring an enhanced water immersion test for packages used for radioactive contents with activity greater than 10

5

A

2.

Section 71.61 currently refers to packages for irradiated fuel with activity greater than 37 PBq (10

6

Ci); the water immersion test would need to be changed to apply to Type B packages containing greater than 10

5

A

2

and Type C packages. Given that any package containing spent fuel with activity greater than 37 PBq (10

6

Ci) would also have an activity significantly greater than 10

5

A

2

, such a change would bound Type B spent fuel packages currently addressed in 10 CFR 71.61. Therefore, a specific reference to special requirements for irradiated nuclear fuel shipments would no longer be required.

As mentioned earlier, there is a difference between the test acceptance criteria specified in TS-R-1 and § 71.61. Safety Series No. 6 refers to no rupture, while § 71.61 requires no collapse, buckling, or inleakage of water when subjected to the test conditions. In the September 28, 1995, rulemaking, NRC staff provided justification for the more specific NRC acceptance criteria. The rulemaking stated that: “NRC has since determined that the term ‘rupture’ cannot be determined by engineering analysis and that NRC has decided to change the acceptance criteria for the deep immersion test from ‘rupture’ to ‘collapse, buckling, or inleakage of water'.’

Given that the TS-R-1 background material does not provide any new information on defining the term “rupture” from that provided for Safety Series No. 6, the NRC intends to retain the current interpretation of “rupture” to mean “collapse, buckling, or inleakage of water,” in any revision to § 71.61. During the comment period for the proposed rule, should information be provided about how the term “rupture” should be defined, or on how foreign countries have certified packages to this criterion, then the NRC will consider this in determining whether the “collapse, buckling, or inleakage of water” criteria should be revised before issuing the final rule.

The NRC draft RA indicates that revising Part 71 to require an enhanced water immersion test for packages used for radioactive contents with activity greater than 10

5

A

2

while retaining the current § 71.61 interpretation of “rupture” to mean “collapse, buckling, or inleakage of water,” is appropriate from a safety, regulatory, and cost perspective. The proposed change would improve regulatory efficiency by bringing U.S. regulations in harmony with the standards contained in TS-R-1. This would improve the efficiency of handling imports and exports and would make U.S. standards compatible with other IAEA Members States.

Implementation of the proposed change could result in costs to licensees as they test and certify packages to the proposed standard. The NRC may incur costs for developing procedures, reviewing and approving test results, and recertifying packages. The proposed change may reduce impacts to public health in the case of an accident. A package tested to the new requirements would be able to withstand pressure at increased depths without collapsing, buckling, or allowing inleakage of water, thereby keeping the radioactive materials enclosed. The likelihood of a member of the public receiving a dose from a package resting in deep water is exceedingly small and would be even smaller if the proposed change were implemented in that the test would apply to a broad range of packages. Moreover, the duration of the test, 1 hour, is reasonable for a package resting in deep water, because the water pressure will be constant, and the 1-hour test will clearly establish if the package can withstand that pressure. A successfully-tested package would be able to withstand the pressure at this depth without rupturing, thereby keeping the radioactive materials enclosed and permitting a reasonable length of time for recovery. Retaining package integrity would prevent the possible expenses of restricting the area (to prevent users such as boaters or fishers from entering the vicinity) and remediating any contamination of the marine environment.

NRC Proposed Position.

The NRC proposes to adopt the requirement for enhanced water immersion test for packages used for radioactive contents with activity greater than 10

5

A

2

. The NRC intends to retain the current test requirements in § 71.61 of “one hour without collapse, buckling, or inleakage of water.”

Affected Sections.

§§ 71.41, 71.51, 71.61.

Issue 8. Grandfathering Previously Approved Packages

Background.

Historically, the IAEA, DOT, and NRC regulations have included transitional arrangements or “grandfathering” provisions whenever the regulations have undergone major revision. The purpose of grandfathering is to minimize the costs and impacts of implementing changes in the regulations on existing package designs and packagings. Grandfathering typically includes provisions that allow: (1) Continued use of existing package designs and packagings already fabricated, although some additional requirements may be imposed; (2) completion of packagings that are in the process of being fabricated or that may be fabricated within a given time period after the regulatory change; and (3) limited modifications to package designs and packagings without the need to demonstrate full compliance with the revised regulations, provided that the modifications do not significantly affect the safety of the package.

Each transition from one edition of the IAEA regulations to another (and the corresponding revisions of the NRC and DOT regulations) has included grandfathering provisions. The 1985 and 1985 (as amended 1990) editions of Safety Series No. 6 contained provisions applicable to packages approved under the provisions of the 1967, 1973, and 1973 (as amended) editions of Safety Series No. 6. TS-R-1 includes provisions which apply to packages and special form radioactive material approved under the provisions of the 1973, 1973 (as amended), 1985, and 1985 (as amended 1990) editions of Safety Series No. 6.

TS-R-1 grandfathering provisions (see TS-R-1, paragraphs 816 and 817) are more restrictive than those previously in place in the 1985 and 1985 (as amended 1990) editions of Safety Series No. 6. The primary impact of these two paragraphs is that packagings approved under the 1967 edition of Safety Series No. 6 are no longer grandfathered, i.e., cannot be

used. The second impact is that fabrication of packagings designed and approved under Safety Series No. 6 1985 (as amended 1990) must be completed by a specified date. In regard to special form radioactive material, TS-R-1 paragraph 818 does not include provisions for special form radioactive material that was approved under the 1967 edition of Safety Series No. 6. Special form radioactive material that was shown to meet the provisions of the 1973, 1973 (as amended), 1985, and 1985 (as amended 1990) editions of Safety Series No. 6 may continue to be used. However, special form radioactive material manufactured after December 31, 2003, must meet the requirements of TS-R-1. Within current NRC regulations, the provisions for approval of special form radioactive material are already consistent with TS-R-1.

In TS-R-1, packages approved under Safety Series No. 6 1973 and 1973 (as amended) can continue to be used through their design life, provided the following conditions are satisfied: multilateral approval is obtained for international shipment, applicable TS-R-1 QA requirements and A

1

and A

2

activity limits are met, and, if applicable, the additional requirements for air transport of fissile material are met. While existing packagings are still authorized for use, no new packagings can be fabricated to this design standard. Changes in the packaging design or content that significantly affect safety require that the package meet current requirements of TS-R-1.

TS-R-1 further states that those packages approved for use based on the 1985 or 1985 (as amended 1990) editions of Safety Series No. 6 may continue to be used until December 31, 2003, provided the following conditions are satisfied: TS-R-1 QA requirements and A

1

and A

2

activity limits are met and, if applicable, the additional requirements for air transport of fissile material are met. After December 31, 2003, use of these packages for foreign shipments may continue under the additional requirement of multilateral approval. Changes in the packaging design or content that significantly affect safety require that the package meet current requirements of TS-R-1. Additionally, new fabrication of this type packaging must not be started after December 31, 2006. After this date, subsequent package designs must meet TS-R-1 package approval requirements.

Discussion.

Industry representatives were concerned that IAEA is adopting a 2-year revision cycle to TS-R-1. From a design approval point of view, the regulatory requirements to be met may not be understood, and, as a new design requirement is approved, new revisions to the regulations could conceivably be developed. In other words, industry may always be playing catch up with the regulations.

Previously, the IAEA standards permitted a package to be manufactured for two revision cycles of the IAEA standard. Because the IAEA standard was revised every 10 years, this equated to a 20-year period. However, IAEA is now changing to a 2-year revision cycle. Retaining the two-cycle provision would now equate to a 4-year allowable manufacturing period. This issue is under review by IAEA. Therefore, the NRC is proposing to specify in existing § 71.13 when packages can no longer be manufactured or used, rather than using a “two-revision cycle” approach.

Additionally, a commenter expressed concern that beyond 2006, while packages could continue to be used under a valid CoC, no new packages could be manufactured based on any edition of Safety Series 6. Furthermore, all packages fabricated after December 31, 2006, would have to fully meet TS-R-1 requirements. The commenter stated that the licensing process for a package could be impacted. While NRC is aware and understands this concern, the proposed changes to § 71.13 are adequate to address the potential limitation on fabrication and use.

One commenter stated that the expense of designing and fabricating large Type B and spent fuel packages cannot be justified if the potential lifetime of the cask is limited to as short a period of time as 6 years. The commenter also believed that design and contents modifications should be allowed as specified in the current § 71.13(c). Conversely, one commenter stated that a 2-year updating cycle would force safety considerations in cask design up front, rather than continuing the attitude that casks be used as long as possible.

Another commenter urged NRC to include a grandfathering provision for continued transportation of packages, such as NRC-approved packages and DOT specification packages. The commenter explained that if NRC did not have a grandfathering provision, NRC would have to set aside hundreds of long-term disposal sites for the various Type B quantity containers currently in use at hospitals and research institutions.

Several commenters believed that grandfathering would allow the NRC to maintain an adequate level of safety for package designs. Some commenters stated that existing packages (even older ones) were safe and durable, because these packages must be maintained in accordance with the QA regulations of Part 71. Another commenter added that under current regulations, NRC may immediately recall a certification if a particular package created a safety concern.

One commenter voiced support for the proposal, assuming new regulations would continue to be more strict. Two commenters believed that while it is important for more stringent requirements to apply to all existing containers, relaxed provisions would effectively make newer containers less safe. In these instances, the commenters preferred that the older provisions remain in effect, instead of the newer, relaxed provisions. One commenter opposed grandfathering existing packages, and stated as a concern the unknown safety of older packages.

One commenter believed that NRC should incorporate specific requirements into the grandfathering provision to effectively maintain a good package program. The commenter explained that manufacturers of CoC containers or packages should be allowed to show, by calculations or testing, that upgraded standards and TS-R-1 have been achieved.

One commenter stated that the shorter cycle would put pressure on cask designers to make safety a more important design element.

In response to the question about the type and magnitude of package design changes that should be allowed for grandfathered packages before recertification is required, two commenters stated that TS-R-1 allows for a phase out of manufacturing of any packages that are not certified to the 1996 version of TS-R-1 by December 31, 2006. The commenters added that this provides a window for the design, testing, and certification of new packages, the reevaluation of existing packages to the 1996 specification, or a request for special certification.

The NRC recognizes that when the regulations change there is not necessarily an immediate need to discontinue use of packages that were approved under previous revisions of the regulations. Part 71 has included provisions that would allow previously-approved designs to be upgraded and to be evaluated to the newer regulatory standards. NRC believes that packages approved under the provisions of the 1967 edition of Safety Series No. 6, and which have not been updated to later editions, may lack safety enhancements which have been included in the packages approved under the provisions of the 1973, 1973 (as amended), 1985 and 1985 (as amended 1990) editions of Safety Series No. 6. Therefore, the NRC

believes that it is appropriate to begin a phased discontinuance of these earlier packages (1967-approved) to further improve transport safety.

The following enhanced safety features have been included in NRC-certified designs approved to these later standards. The NRC revised 10 CFR Part 71 in 1983 for compatibility with the provisions of the 1973 edition of Safety Series No. 6 to include:

1. The introduction of the A

1

and A

2

system. Before the 1973 edition of Safety Series No. 6, the regulations were based on Transport Groups. The A

1

and A

2

system was intended to use a consistent safety basis for package contents based on radiological protection in transportation under normal and accident conditions.

2. Standards for defining acceptable containment system performance. The 1973 edition of Safety Series No. 6 included for the first time activity limits for loss of radioactive contents from Type B packages under normal conditions of transport and under hypothetical accident conditions. The containment system performance requirements were tied to the A

1

and A

2

values, as described above.

3. The immersion test for Type A fissile material packages. The 1973 edition of Safety Series No. 6 required that the 15-meter (50-ft) water immersion test, previously required as a hypothetical accident test only for Type B packages, also be applied to fissile material packages. This immersion test is important in considering the degree of internal moderation (i.e., possible inleakage of water) in the criticality safety evaluation for fissile material packages in arrays.

4. Maximum normal operating pressure (MNOP). The 1973 edition of Safety Series No. 6 added a revised definition of MNOP. The definition for MNOP was included in Part 71 and specifically excluded consideration of package venting and active cooling systems.

5. Environmental test conditions. The 1973 edition of Safety Series No. 6 specified for the first time the high and low temperatures, pressures, and weights that should be considered when evaluating the package under normal and accident condition tests.

6. Quality Assurance (QA) requirements. The requirements to apply QA to the design, fabrication, and use of transportation packages were proposed in Part 71 in 1973. Although the IAEA regulations did not adopt QA requirements until the 1985 edition of Safety Series No. 6, NRC regulations required QA controls before IAEA adopted these provisions. QA program requirements are only imposed on packages approved for use after 1979. Packages approved under the 1973 edition of Safety Series No. 6 include QA in their design and fabrication, whereas, with a few exceptions (such as spent fuel casks), packages approved under earlier editions do not include QA program requirements.

The NRC draft RA indicates that adopting the grandfathering provisions for packagings approved under the 1985 editions of Safety Series No. 6 (known as “-85” packagings) and the associated expiration dates, is appropriate from a safety, regulatory, and cost perspective. From a regulatory standpoint, the proposed revisions would result in enhanced regulatory efficiency by bringing NRC's requirements in harmony with those contained in TS-R-1.

NRC does not currently have sufficient information to quantify the economic impacts of adopting this provision. The estimated costs to industry are not quantifiable due to a lack of sufficient data. However, industry is expected to bear costs associated with the need to redesign existing packages, address the reduction in availability of packages, and determine the years of service expected from the original design. Should NRC receive comments providing detailed information on the potential economic impacts to industry, the draft RA would be revised accordingly.

The proposed change would also result in implementation costs of approximately $3,500 to the NRC. The NRC would have to revise regulatory guides and NUREG-series documents to indicate which packages are covered by the “grandfathering of older packages” provision. Further, the proposed change could result in implementation and operation costs of approximately $1,000 to Agreement States if they adopt and implement parallel requirements. (The proposed change is not expected to affect implementation or operation costs of DOT.) Agreement States use regulatory guides and NUREG-series documents published by the NRC. Thus, Agreement States would only need to revise documents that they have specifically developed for their licensees (e.g., application materials). In terms of public health and safety, the existing and proposed requirements are believed to be equally protective. Thus, neither an increase nor a decrease in potential health and safety impacts is expected as a result of adopting the proposed administrative changes. Should the NRC become aware that a package or package design is unsafe, that package or design would be removed from service.

NRC Proposed Position.

NRC supports the update to grandfathering in TS-R-1 and is proposing to revise Part 71 to discontinue authorization to use packages approved under the provisions of the 1967 edition of Safety Series No. 6. Specifically, NRC is proposing to make modifications to existing § 71.13 to phase out these types of packages. NRC realizes the impact this proposal may have on shipments using existing NRC-approved packages. Therefore, NRC proposes a 3-year transition period for the grandfathering provision on packages approved under the provisions of the 1967 edition of Safety Series No. 6. This period would provide industry the opportunity to phase out old packages and phase in new ones, or demonstrate that current requirements are met.

For transitional arrangements for newer designs, NRC is proposing to incorporate into § 71.13(c) the provisions for packagings approved under the 1985 editions of Safety Series No. 6 (known as “-85” packagings) and the associated expiration dates. Additionally, paragraph (e) of § 71.13 has been revised to specify the process by which previously-approved designs may be amended to include the “-96” designation.

In summary, the following conditions would apply: (1) Packages approved under NRC standards that are compatible with the provisions of the 1967 edition of Safety Series No. 6 may no longer be fabricated, but may be used for a 3-year period after adoption of a final rule; (2) Packages approved under NRC standards that are compatible with the provisions of the 1973 or 1973 (as amended) editions of Safety Series No. 6 may no longer be fabricated; however, the proposed rule would not impose any restrictions on the use of these packagings; (3) Packages approved under NRC standards that are compatible with the provisions of the 1985 or 1985 (as amended 1990) editions of Safety Series No. 6, and designated as “-85” in the identification number, may not be fabricated after December 31, 2006, but may continue to be used; (4) Package designs approved under any pre-1996 IAEA standards (i.e., packages with a “-85” or earlier identification number) may be resubmitted to the NRC for review against the current standards. If the package design described in the resubmitted application meets the current standards, the NRC may issue a new CoC for that package design with a “-96” designation.

Affected Sections.

§ 71.13.

Issue 9. Changes to Various Definitions

Background.

The changes contemplated by NRC in this proposed rulemaking would require changes to various definitions in § 71.4 to provide internal consistency and compatibility with TS-R-1. The terms must be clearly defined so that they can be used to accurately communicate requirements to licensees. By modifying existing definitions and adding new definitions, the licensee would benefit through more effective understanding of the requirements of Part 71.

Discussion.

Eight commenters submitted information on changes to various definitions in the proposed rule. One commenter stated that the definitions should be adopted to the extent the terms are used in the updated regulations. Another commenter urged NRC to be clear, consistent, and precise, particularly regarding the definitions of “rupture,” “collapse,” “buckling,” and “inleakage.” Two other commenters stated that the TS-R-1 definition identifies the specific types of packaging allowed for Class 7, and unless DOT revises its regulations, there will be a domestic conflict. Therefore, these commenters do not recommend this change. The commenters added that NRC should consider definitions that explain the differences among “uniformly distributed,” “distributed throughout,” and “homogeneous.”

Another commenter stated that the existing regulation defines special form radioactive material that has been demonstrated to comply with specific tests. The commenter added that TS-R-1, paragraph 225, introduces the term “low dispersible radioactive material,” but fails to provide any guidance as to what characteristics qualify the material. Another commenter stated that the definition for “low dispersible radioactive material” should indicate that this does not refer to surface contamination, but rather activation of a solid material. This commenter also suggested adding the term “sealed source” to mean (for use of A1 values) encapsulated radioactive material that was designed and manufactured under a specific license and has been assigned a sealed source identification registry number.

One commenter stated that the proposed definitions of “confinement system” and “package” are indistinguishable for packages intended to transport fissile material. The commenter urged NRC to use only one term or to clearly distinguish between the two definitions. The commenter added that if the definition of “confinement system” is added, the term “competent authority” must also be defined, and if the definition of “package” is incorporated, definitions of “excepted” and “industrial” must be added. Another commenter stated that the confinement system definitions should be revised to include fuel assemblies, the PWR basket, and the shipping cask, because all three provide different levels and degrees of confinement.

The NRC draft RA indicates that revising Part 71 to modify existing and add new definitions is appropriate from a safety, regulatory, and cost perspective. The proposed changes would provide greater internal consistency and compatibility with TS-R-1. By modifying existing definitions and adding new definitions, licensees would benefit through a more effective understanding of the requirements of Part 71.

Specifically, industry will realize costs savings by benefitting from a more effective understanding of the requirements of Part 71. These costs savings are expected to be minimal, and are not quantifiable due to a lack of available data.

The proposed changes would result in approximately $3,500 in implementation costs to the NRC. The NRC would have to revise regulatory guides and NUREG-series documents to include the new or revised definitions of § 71.4. The proposed changes could affect implementation and operation costs of Agreement States because they would have to adopt the revision to the various definitions in § 71.4. (The proposed change is not expected to affect implementation or operation costs of DOT.) Because Agreement States use regulatory guides and NUREG-series documents published by the NRC, they would only need to revise documents that they have developed specifically for their licensees.

Additionally, as a means of improving use and understanding of Part 71, the following existing definitions from § 71.4 would be modified: A

1

, A

2

, and Low Specific Activity, specifically LSA-III. The definitions that are structured in § 71.4 are presented in italicized print as a means of distinguishing them from the corresponding text. The definition of LSA-III material would be modified to reference the testing provisions for LSA-III material found in § 71.77. Other definitions (e.g., Special form radioactive material) reference requirements within Part 71 that must be followed.

Lastly, within the Issues Paper, NRC posed the idea of adopting the following definitions from TS-R-1: Confinement System (TS-R-1, paragraph 209) and Quality Assurance (TS-R-1, paragraph 232). NRC is excluding the definition of Confinement system because it is included within the broader definition of Containment system. Further, NRC's use of Quality assurance is somewhat different from that of the IAEA, and NRC will retain the description of Quality assurance found in Subpart H.

NRC Proposed Position.

The NRC is proposing to adopt the TS-R-1 definition of Criticality Safety Index (CSI). Additionally, the following definitions would be revised to improve their clarity: A

1

, A

2

, and LSA-III. Other changes to § 71.4 are proposed in separate issues.

Affected Sections.

§ 71.4.

Issue 10. Crush Test for Fissile Material Package Design

Background.

In TS-R-1, the crush test requirements have been broadened to apply to fissile material package designs (regardless of package activity). Previously, IAEA Safety Series No. 6 and Part 71 have required the crush test for certain Type B packages. This broadened application was created in recognition that the crush environment was a potential accident force that should be protected against for both radiological safety purposes (packages containing more than 1,000 A

2

in normal form) and criticality safety purposes (fissile material package design).

Under requirements for packages containing fissile material, TS-R-1, paragraph 682(b), requires tests specified in paragraphs 719-724 followed by whichever of the following is the more limiting: (1) The drop test onto a bar as specified in paragraph 727(b) and either the crush test as indicated in paragraph 727(c) for packages having a mass not greater than 500 kg (1,100 lbs) and an overall density not greater than 1,000 kg/m

3

(62.4 lbs/ft) based on external dimensions, or the 9-meter (30-ft) drop test as defined in paragraph 727(a) for all other packages; or (2) the water immersion test as specified in paragraph 729.

Both the Safety Series No. 6, paragraph 548, and the current § 71.73 require the crush test for packages having a mass not greater than 500 kg (1,100 lbs), an overall density not greater than 1,000 kg/m

3

(62.4 lbs/ft) based on external dimensions, and radioactive contents greater than 1,000 A

2

not as special form radioactive material. Under TS-R-1, the criterion for radioactive contents greater than 1,000 A

2

has been eliminated for packages containing fissile material. The 1,000 A

2

criterion still applies to Type B packages and is also applied to the

IAEA newly created Type C package category.

Discussion.

Several commenters provided feedback regarding crush test requirements for packages containing fissile material. A number of commenters urged NRC to keep the current regulations requiring the crush test and the free drop test. One commenter stated that the crush test was especially useful for large packages. Another commenter supported the test and stated that U.S. transportation activities should be consistent with IAEA transportation regulations. Similarly, one commenter stated that the testing sequence as required in TS-R-1 should be adopted to assure international uniformity. One commenter recommended removing the optional requirement of either a crush or a drop test, and replacing it with a requirement to conduct both tests.

One commenter requested that NRC improve the realism associated with crush tests. The commenter stated that the crush test should be a physical test rather than using a computer model simulating a test. Additionally, the test should use full-scale packages that are loaded with nonradioactive materials to provide improved test reliability. This commenter stated that crush tests should be included for all package sizes, and the test parameters should be increased to reflect real-world conditions.

A few commenters stated that the proposed requirement to use the free drop test or the crush test is problematic because the results of these tests are different and could require reanalysis of current packages.

One commenter stated that elimination of the 1,000 A

2

activity limit, without providing for flexibility in test sequencing, would be an unfair and costly burden. The commenter stated that Part 71 should be changed to conform to TS-R-1 in all aspects, or not be changed at all. Another commenter stated that the impact of the elimination of the 1,000 A

2

activity limit for fissile material packages having a mass not greater than 500 kg (1,100 lbs), and overall density not greater than 1,000 kg/m

3

(62.4 lbs/ft), based on external dimensions, is currently unknown. The commenter noted that shipping companies must use international standards established in TS-R-1 to allow international trade. Another commenter supported the removal of the 1,000 A

2

threshold for fissile packages on the grounds that A

2

levels are intended as an index of radiological hazard rather than criticality potential, and it is inconsistent with TS-R-1.

The NRC believes that full compliance with TS-R-1 requirements for fissile material packages would require changes to the hypothetical accident conditions test sequencing of § 71.73 and would require performance of the 9-meter (30-ft) free drop test or the crush test, but not both, as presently required by § 71.73. The TS-R-1 test requirements are essentially the same as those contained in Safety Series No. 6. In the previous NRC rulemaking for compatibility with Safety Series No. 6 (1985 edition), NRC staff addressed this difference in test requirements. In the June 8, 1988; 53 FR 21550, proposed rule, the NRC stated that: “IAEA applies the crush test in place of the 9-meter drop test for the lightweight packages specified. In the absence of experience using the crush test, and because the crush test and drop test evaluate different features of a package, NRC is requiring both the crush test and the 9-meter drop test for the lightweight packages.” Further, in the September 28, 1995; 60 FR 50248, final rule, the NRC stated: “NRC is requiring both the crush test and drop test, for lightweight packages, to ensure that the package response to both crush test and drop forces is within applicable limits.”

The NRC draft RA indicates that revising Part 71 to adopt the TS-R-1 requirements for a crush test for fissile material package design, while maintaining the current testing sequence, is appropriate from a safety, regulatory, and cost perspective. Not adopting the requirement would result in an inconsistency between Part 71 requirements and TS-R-1, which could affect international shipments, and fissile material package designs would continue to not be evaluated for criticality safety against this potential accident condition. However, the NRC believes that further information on the impact of the TS-R-1 requirement for fissile material package testing is required. Imposing the crush test requirement on fissile material package designs may impact the industry through costs imposed to demonstrate compliance and may lead to the redesign of packages. Under present Part 71 standards and Safety Series No. 6, the 1,000 A

2

criterion, used to identify packages that must meet the crush test, essentially exempts all packages designed to contain uranium enriched to five percent or less (due to an unlimited A

2

value). For fissile material package designs, this would only apply to designs for plutonium contents. However, if TS-R-1 is adopted, only the weight and density criteria would apply to fissile uranium material packages, and packages that were previously exempted because of the 1,000 A

2

criterion would now require crush testing. The potential impact on the industry is unknown due to a lack of data on the number of packages shipped under § 71.55 where the 1,000 A

2

value allowed exemption from crush testing. However, to demonstrate compliance with the new regulations, industry may incur additional costs. These potential costs may stem from package redesign but, due to the lack of available data, these costs are not quantifiable. NRC would bear approximately $74,000 in costs. These costs result from the need to prepare documents and conduct other activities (such as publishing notices of rulemakings, holding public hearings, and responding to public comments) as a result of the action.

NRC Proposed Position.

The NRC proposes to adopt the requirement for a crush test for fissile material packages, and eliminate the 1000 A

2

criterion for fissile material packages. However, because there is no new information that addresses concerns from the previous rulemaking regarding the difference in test requirements between Part 71 and Safety Series No. 6, the NRC proposes not to change the testing sequence nor to change the drop and crush test requirements in this revision.

Affected Sections.

§ 71.73.

Issue 11. Fissile Material Package Design for Transport by Aircraft

Background.

TS-R-1 introduced new requirements for fissile material package designs that are intended to be transported aboard aircraft. TS-R-1 requires that shipped-by-air fissile material packages with quantities greater than excepted amounts (which would include all NRC-certified fissile packages) be subjected to an additional criticality evaluation. Specifically, TS-R-1, paragraph 680, requires that packages must remain subcritical, assuming reflection by 20 centimeters (8 inches) of water but no water inleakage (i.e., moderation) when subjected to the tests for Type C packages.

2

The specification of no water ingress is given because the objective of this requirement is protection from criticality events resulting from mechanical rearrangement of the

geometry of the package (i.e., fast criticality). The provision also states that if a package takes credit for “special features,” this package can only be presented for air transport if it is shown that these features remain effective even under the Type C package test conditions followed by a water immersion test. “Special features” generally mean features that could prevent water inleakage (and therefore credit could be taken in criticality analyses) under the hypothetical accident conditions. Special features are permitted under current § 71.55(c).

2

The TS-R-1 imposition of Type C and LDM requirements (see Issue 6) was in recognition that severe aircraft accidents could result in forces exceeding those of the “accident conditions of transport” that are imposed on Type B and fissile package designs. Because the hypothetical accident conditions for Type B packages are the same as those applied to package designs for fissile material, there was also a need to consider how these more severe test conditions should be applied to fissile package designs transported by air.

TS-R-1, paragraph 680, requirements for packages to be transported by air are in addition to the normal condition and accident tests that the package must already meet. Thus:

Type A fissile package by air must:

(A) Withstand normal conditions of transport with respect to release, shielding, and maintaining subcriticality (single package and 5xN array

3

);

3

N represents the maximum number of fissile material packages that can be shipped on a single conveyance.

(B) Withstand accident condition tests with respect to maintaining subcriticality (single package and 2xN array); and

(C) Comply with TS-R-1, paragraph 680, with respect to maintaining subcriticality (single package);

Type B fissile package by air must:

(A) Withstand normal conditions of transport and Type B tests with respect to release, shielding, and maintaining subcriticality (single package and 5xN array/normal and 2xN array/accident); and

(B) Comply with TS-R-1, paragraph 680, with respect to maintaining subcriticality.

There are no provisions in TS-R-1 for “grandfathering” (Issue 8) fissile material package designs, which will be transported by air. TS-R-1, paragraphs 816 and 817, state that these packages are not allowed to be grandfathered. Consequently, all fissile package designs intended to be transported by aircraft would have to be evaluated before their use.

Discussion.

Five commenters provided information regarding our proposal of the TS-R-1 provisions for fissile material package design for transport by aircraft. One commenter expressed concern about the comprehensibility of the regulations for Type B or below quantities of fissile materials. The commenter was aware that the IAEA went through efforts to try to clarify the requirements, but asserted that the regulations need to be understood consistently by the people who approve package designs for transport of fissile materials by air. The commenter stated that this is a critical issue for industry because the International Civil Aviation Organization (ICAO) has adopted TS-R-1 in 2001 and, therefore, shipments must meet the requirements in TS-R-1 for fissile materials. The commenter encouraged Federal agencies, including NRC and DOT, to push the concept of clarification of the rules and consider a streamlined approval process for designs of air transport of fissile material. Another commenter stated that TS-R-1 writers are working to develop a table that takes into consideration mass, enrichment, and moderation to define an acceptable limit for shipment by air.

One commenter asked when and in what situations the transportation of fissile level material by air would be required.

Two commenters supported the inclusion of these requirements as they are generally in parallel with those in place for surface mode accidents.

The NRC draft RA indicates that adopting TS-R-1 paragraph 680 for criticality evaluation (only applicable to air transport) is reasonable from a safety, regulatory, and cost perspective. Adopting this change would provide the NRC with the regulatory framework for approving package designs that will be used internationally. Shippers will be required to meet these requirements even if the NRC does not adopt them, because the ICAO has adopted regulations consistent with TS-R-1 on July 1, 2001. U.S. domestic air carriers require compliance with the ICAO regulations even for domestic shipments.

These changes are expected to benefit industry by eliminating the need for two different package designs. The amount of these savings, however, are not quantifiable due to a lack of data.

NRC Proposed Position.

The NRC proposes to adopt TS-R-1, paragraph 680, Criticality evaluation, in a new proposed § 71.55(f) that only applies to air transport. Section 71.55 specifies the general package requirements for fissile materials, and the existing paragraphs of § 71.55 are unchanged. Because (1) the NRC is deferring adoption of the Type C packaging tests (see Issue 6); (2) TS-R-1, paragraph 680, references the Type C tests; and (3) paragraph 680 applies to more than Type C packages, only the salient text would be inserted into § 71.55(f), and would apply to domestic shipments.

Affected Sections.

§ 71.55.

D. NRC-Initiated Issues

Issue 12. Special Package Authorizations

Background.

The basic concept for radioactive material transportation is that radioactive contents are placed in an authorized container, or packaging, and then shipped. The packaging, together with its contents, is called the package. In general, the transportation regulations in TS-R-1, 10 CFR Part 71, and Title 49 are based on the shipment of radioactive contents in a separate, authorized packaging. There are a few exceptions, however. For example, TS-R-1 provides that the least radioactive of the Low Specific Activity materials (LSA-I) and Surface Contaminated Objects (SCO-I) may be shipped unpackaged, provided certain conditions are met. Title 49 permits shipment of LSA-I materials in bulk, where the conveyance (e.g., truck or freight container) serves as the packaging.

In other cases involving larger quantities of radioactive material, the content to be shipped may itself be a container. A storage tank containing a radioactive residue is an example. It is not necessary for the shipper to place the tank within an authorized packaging, if the shipper demonstrates that the tank satisfies the requirements for the packaging. DOT and NRC have jointly provided guidance on such shipments (see “Categorizing and Transporting Low Specific Activity Materials and Surface Contaminated Objects,” NUREG-1608, RAMREG-003, July 1998).

As older nuclear facilities are decommissioned, DOT and NRC are being asked to approve the shipment of large components, including reactor vessels and steam generators. These components may contain significant quantities of radioactive material, but they are so large that it is not practical to fabricate authorized packagings for them. Because these components were not contemplated when the regulations were developed, the regulations do not specifically address them.

Basically, large components can be shipped under DOT regulations if the components meet the definition of Surface Contaminated Object (SCO) or Low Specific Activity (LSA) material (see 49 CFR 173.403 for SCO and LSA definitions). For example, steam generators that meet the SCO definition are exempt from Part 71 and are shipped under Title 49, following guidance provided in NRC Generic Letter 96-07 dated December 5, 1996. This method has been applied to several shipments of steam generators and small reactor

vessels to the low level waste disposal facility at Barnwell, SC. NRC and DOT intend to continue employing this approach and method for steam generators and similar components that can be shipped under DOT regulations.

Large components that exceed the SCO and LSA definitions are subject to Part 71. An example is the Trojan reactor vessel. By letter dated March 31, 1997, Portland General Electric Company (PGE) requested approval of the Trojan Reactor Vessel Package (TRVP) (including internals) for transport to the disposal facility operated by U.S. Ecology on the Hanford Nuclear Reservation near Richland, Washington. The TRVP contained approximately 74 PBq (2 million Ci) in the form of activated metal and 5.7 TBq (155 Ci) in the form of internal surface contamination, was filled with low-density concrete and weighed approximately 900 metric tons (1,000 tons). Normally, large curie contents are required to be shipped in a Type B packaging, but the TRVP was too large and massive to be shipped within another packaging.

PGE acknowledged that the TRVP could not meet Type B regulations and applied for a Type B package CoC for the TRVP itself, either under § 71.41(c), “Demonstration of compliance,” or § 71.8, “Specific exemptions.” Section 71.41(c) provides that “Environmental and test conditions different from those specified in §§ 71.71 and 71.73 may be approved by the Commission if the controls proposed to be exercised by the shipper are demonstrated to be adequate to provide equivalent safety of the shipment.” Section 71.41(c) has been used to accommodate minor deviations in test environments (e.g., initial temperatures), and was not intended to be used to establish new test conditions for Type B packages. The use of this provision in the Trojan case would essentially have resulted in establishing new (and less rigorous) Type B test conditions that the Trojan vessel could meet. A CoC for a Type B package could then have been issued for Trojan, but the level of performance reflected in that Certificate would have been significantly different from that in other Type B Certificates. NRC decided against using § 71.41(c), and to use the § 71.8 exemption provision—the only other option available.

Section 71.8 provides that NRC may grant any exemption from the requirements of the regulations in Part 71 that it determines is authorized by law and will not endanger life or property nor the common defense and security. The exemption approach had three impacts on the TRVP review. First, the NRC's categorical exclusion from preparing an Environmental Assessment (EA) pursuant to the National Environmental Protection Act (NEPA) for package approvals (§ 51.22(c)(13)) does not apply to packages authorized under an exemption. Consequently, an EA of the proposed exemptions was required. Second, DOT's regulations that govern radioactive material shipments do not recognize packages approved via NRC exemption. PGE was therefore required to obtain an exemption from DOT regulations in 49 CFR Part 173 for the TRVP shipment. Third, use of the exemption option provided a mechanism for NRC to consider the operational and administrative controls, which were proposed by PGE to influence shipment risk factors. Considering the statements and representations contained in the application, as supplemented, and the conditions specified in the package approval, NRC concluded that the TRVP, as exempted, met the requirements of Part 71, and recommended that the Commission approve the exemptions and the TRVP shipment.

Currently, no regulatory provisions exist in Part 71 for dealing with nonstandard packages, other than the exemption provisions and § 71.41(c). The NRC's policy is to avoid the use of exemptions for recurring licensing actions. Therefore, as a lesson learned from the Trojan approval, the NRC staff identified large component package authorizations as an issue for consideration in this proposed rule.

Discussion.

Numerous comments were received on the special package approvals issue in response to the Issues Paper, from the public meetings, and from NRC's website. One of the commenters supported the idea of creating a system for providing special package approvals without using the existing exemption requirements. This commenter noted that his agency found it very useful to realize that there are packages or materials outside the current scope of NRC regulations that still need to be transported as they cannot stay where they are. The commenter agreed that it is appropriate to have a method to address these issues.

A number of commenters did not support the development of a special package approvals regulation. These commenters believed the issue of special package approvals should be conducted on a case-by-case basis, using the current exemption process. One commenter noted that “hot decommissioning” and “hot” shipping introduce a new regimen, and therefore, the commenter believed that the only way for the NRC to proceed is with a case-by-case, very individual and specialized exemption or allowance, if at all. The commenter went on to say that the people who are on the first lines, the first responders and the emergency management coordinators at the local level, and the people who are in transport corridor communities have a right to information that a specialized process (i.e., an exemption process) would provide. The commenter stated that the concerns of the public who are in these transport corridor communities are not being given adequate weight in decision making, and the opportunities for discussion are too limited. Finally, this commenter stated that removing the exemption process for big, unusual shipments could set the stage for applying this concept to other types of materials to be exempted from testing and packaging requirements which the commenter believed would be a bad precedent.

Two commenters expressed concern over the definition of a “special large object.” One commenter stated that if special provisions are added, then the term “large” must be defined with respect to both size and weight. Another commenter requested that NRC consider revisions to Part 71 to address large objects in general, that would include reactor vessels.

Three commenters spoke to the issue of Type B quantities. The first commenter stated that there could be overlap between orphan sources and Type B quantities. This commenter recommended that Type B orphan sources be included in a separate rule from the special large packages. The second commenter would like to see collaboration between the NRC and DOT to address the possibility of initiating a program that would minimize package review costs of decommissioning Type B quantities of cobalt-60 and cesium-137. Two commenters stated that there have been cases where a Type B package has been damaged in a way that it will continue to secure and shield the sources, but does not meet compliance standards. The commenters noted that in these types of cases, a special arrangement certificate would be beneficial to allow transport of the damaged equipment for disposal.

Several commenters did not believe that NRC's use of the shipment of the Trojan reactor vessel was an adequate basis for determining whether or not to remove the requirement for exemptions for special packages and replace it with other provisions. One commenter noted that because the Trojan vessel was

shipped by barge, a lot of the risk of exposure that would normally be present in other transport modes was removed (e.g., a truck being caught in traffic). This commenter also stated that moving to a risk-informed decision making process for special package approvals may result in a situation where the public is “informed to more risk while the industry is exposed to less regulation.” Another commenter noted that if NRC is using the shipment of the Trojan reactor vessel as its baseline for determining whether to revise its regulations, care should be taken to limit the scope of this special approval to NRC's responsibilities and expertise. The commenter noted that as the Trojan approval process moved along, there was a difference of opinion as to the extent of NRC's evaluation of river and barging conditions, when in reality, these issues are the jurisdiction of the Coast Guard, and if the Coast Guard had approved the waterway and the conveyance, it should not be necessary for this information to be a part of an application to NRC subject to NRC review and approval. Other commenters disagreed. One commenter added that significant experience has already been gained in exempting the Trojan reactor vessel, a precedent has been established, and the possibility exists that the requirements placed on the shipment of the Trojan reactor vessel might have been more restrictive than might have been determined as necessary. Two commenters stated that the Trojan shipment review is a point of reference for the basis of other similar shipments, but that each case should still be assessed on its own merits.

A number of commenters raised specific issues that NRC should consider when deciding whether to propose a special package approval process and how that process should be defined. Two commenters noted that the system has been defined as to how these materials should be moved and what kind of information needs to be provided to the regulators to move the materials. These commenters further noted that any change to Part 71, with respect to these special shipments, needs to be specific to those items that are going to be regulated under the MOU between the NRC and DOT. The two commenters added that the majority of those items that get moved are large components and would fall under the DOT's jurisdiction under the MOU. Thus, DOT would regulate items like steam generators and demineralizers and pressurizers, all of which are pieces and parts of reactors that are being decommissioned. NRC would regulate items like reactor pressure vessels (e.g., the Trojan reactor pressure vessel).

One commenter did not support the adoption of an analog of the IAEA special arrangements provisions in Part 71. The commenter did not support the adoption of this type of provision in Part 71 because the IAEA special arrangements were specifically designed for movement internationally, whereas most of these items would be moved domestically.

One commenter provided input on the specific issue of what additional determinations should be included in an application for a special package approval. The commenter noted that a precedent has already been established with the requirement that a transportation plan be provided with the exemption requests. The transportation plan contains safety features that would be substituted for the current codified requirements that would provide an equivalent order of safety, considerations of the entire safety system versus independent components of safety, emergency response plans, and risk-informed considerations.

The NRC processing of one-time exemptions for nonstandard packages, such as the Trojan vessel, represents expenditure of considerable staff resources. Once the application for exemption is received, the staff spends a significant amount of time reviewing the application and preparing an EA. The Commission itself has been involved in the approval of these actions. Rather than exempting nonstandard packages from regulations, as was necessary for Trojan, the staff is proposing that regulatory requirements be added to Part 71 which would address nonstandard packages. These special packages are likely to increase in number as a result of future decommissioning activities.

The NRC is proposing a regulatory mechanism to address large component shipments. In this regard, NRC has considered TS-R-1, paragraph 312, entitled Special Arrangement:

Consignments for which conformity with the other provisions of these regulations is impracticable shall not be

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