# Compatibility With IAEA Transportation Safety Standards (TS-R-1) and Other Transportation Safety Amendments > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A04-35 ## Record - **Collection:** Federal Register - **Document type:** Rule - **Published:** January 26, 2004 - **Citation:** 69 FR 3698 ## Text 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: Final rule. SUMMARY: The Nuclear Regulatory Commission (NRC) is amending its regulations on packaging and transporting radioactive material. This rulemaking will make the regulations compatible with the latest version of the International Atomic Energy Agency (IAEA) standards and codify other applicable requirements. This final rule also makes changes in fissile material exemption requirements to address the unintended economic impact of NRC's emergency final rule entitled “Fissile Material Shipments and Exemptions” (February 10, 1997; 62 FR 5907). Lastly, this rule addresses a petition for rulemaking submitted by International Energy Consultants, Inc. EFFECTIVE DATE: This final rule is effective on October 1, 2004. Portions of §§ 71.19 and 71.20 expire on October 1, 2008. FOR FURTHER INFORMATION CONTACT: Naiem S. Tanious, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone (301) 415-6103; e-mail nst@nrc.gov . SUPPLEMENTARY INFORMATION: Contents I. Background II. Analysis of Public Comments III. 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 (UF 6 ) 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 (QA) Requirements to Certificate of Compliance (CoC) Holders Issue 14: Adoption of the 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: Decision on Petition for Rulemaking on 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 IV. Section-By-Section Analysis V. Criminal Penalties VI. Issues of Compatibility for Agreement States VII. Voluntary Consensus Standards VIII. Environmental Assessment: Finding of No Significant Environmental Impact IX. Paperwork Reduction Act Statement X. Regulatory Analysis XI. Regulatory Flexibility Act Certification XII. Backfit Analysis I. Background Before developing and publishing a proposed rule, the NRC began an enhanced public-participation process designed to solicit public input on the part 71 rulemaking. The NRC issued a part 71 issues paper for public comment (65 FR 44360; July 17, 2000). The issues paper presented the NRC's plan to revise part 71 and provided a summary of all changes being considered, both International Atomic Energy Agency (IAEA)—related changes and NRC-initiated changes. The NRC received 48 public comments on the issues paper. The NRC enhanced public participation process included establishing an interactive Web site and holding three facilitated public meetings: a “roundtable” workshop at 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. Oral and written comments, received from the public meetings by mail and through the NRC Web site, in response to the issues paper were considered in drafting the proposed rule. The NRC published the proposed rule in the Federal Register on April 30, 2002 (67 FR 21390), for a 90-day public comment period. In addition to approving the publication of the proposed rule, the Commission also directed the NRC staff to continue the enhanced public participation process. The NRC staff held two public meetings to discuss the proposed rule. The first meeting was held in Chicago, Illinois, on June 4, 2002, and the second was held at the TWFN Auditorium, NRC Headquarters, on June 24, 2002. In addition, the Department of Transportation (DOT) staff participated in these meetings. Transcripts of these meetings were made available for public review on the NRC Web site. The public comment period closed on July 29, 2002. A total of 192 comments were received. Although many comments were received after the closing date, all comments were analyzed and considered in developing this final rule. 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 a revision of 10 CFR part 71. That revision, in combination with a parallel revision of the hazardous materials transportation regulations of 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, Safety Standards Series ST-1, was published in December 1996, and revised with minor editorial changes in June 2000, and redesignated as TS-R-1. Historically, the NRC has 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 49 CFR under DOT authority. Currently, DOT and NRC co-regulate transport of nuclear material in the United States. The 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 presented in this final rule. Scope of 10 CFR Part 71 Rulemaking As directed by the Commission, the 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, the NRC staff identified 11 areas in part 71 that needed to be addressed in this rulemaking as a result of the changes to the IAEA regulations. The NRC staff grouped the part 71 IAEA compatibility changes into the following issues: (1) Changing part 71 to the International System of Units (SI) only; (2) radionuclide exemption values; (3) revision of A 1 and A 2 ; (4) uranium hexafluoride (UF 6 ) package requirements; (5) introduction of the criticality safety index requirements; (6) type C packages and low dispersible material; (7) deep immersion test; (8) grandfathering previously approved packages; (9) changes to various 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 NRC staff consideration for incorporation in part 71. These NRC-initiated changes are: (12) Special package authorizations; (13) expansion of part 71 Quality Assurance (QA) requirements to Certificate of Compliance (CoC) holders; (14) adoption of the American Society of Mechanical Engineers (ASME) code; (15) change authority for Dual-Purpose Package Certificate holders; (16) fissile material exemptions and general license provisions; (17) decision on petition for rulemaking on PRM-71-12, Double Containment of Plutonium; (18) contamination limits as applied to Spent Fuel and High-Level Waste (HLW) packages; and (19) modifications of event reporting requirements. The first 18 issues were published for public comment in an issues paper in the Federal Register on July 17, 2000 (65 FR 44360). Also, the authority citation for part 71 has been corrected to include section 234. This final rule has been 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. The DOT also published its proposed rule regarding adoption of TS-R-1 April 30, 2002 (67 FR 21328). II. Analysis of Public Comments As previously stated, the NRC held two facilitated public meetings in 2002 to discuss and hear public comments on the proposed rule. (Three other facilitated public meetings were held in 2000 before drafting the proposed rule.) Each of these meetings was 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 Web site at http://ruleforum.llnl.gov. and the Public Document Room (PDR) located at One White Flint North, 11555 Rockville Pike, Room O-1F23, Rockville, MD. The NRC has made copies of publicly released documents available on the Web site at http://www.nrc.gov/waste/spent-fuel-transp.html. This section provides a summary of the general comments not associated with the 19 issues but rather with general topics related to this rule and the rulemaking process. These are organized under the following subheadings: Compatibility with IAEA and DOT standards, Regulatory Analysis (RA) and Environmental Assessment (EA), State Regulations, Terrorism, Adequacy of NRC Regulations and Rulemaking Process, Proposed Yucca Mountain Facility, and Miscellaneous (including comments to DOT). A summary of public comments associated with a specific issue is included in Section III of this SUPPLEMENTARY INFORMATION . Compatibility With IAEA and DOT Standards Comment. Several commenters generally supported NRC's efforts to be consistent with IAEA regulations. The particular reasons for this support varied among commenters but included such issues as approving of harmonization and encouraging NRC's coordination with DOT. For example, some commenters stated that harmonization enhances the industry's ability to import shipments and conduct business in compliance with both national and international regulations. One commenter urged the NRC to move swiftly to complete this rulemaking effort and to remain consistent with DOT regulations. One commenter stated that uniform international regulations were in the public's best interest for the safe movement of nuclear materials. Further, this commenter urged the NRC to accelerate the “harmonization” with international regulations to simplify procedures for companies that ship nuclear waste both domestically and internationally. Response. The NRC acknowledges these comments, and the NRC continues to work to finalize this rule as expeditiously as possible. As with the issuance of the proposed rule, the NRC will continue to coordinate closely with the DOT in this effort to ensure consistency between regulations for the transportation of certain radioactive materials. Comment. A commenter supported harmonization but said that adoption of new or modified requirements into the domestic regulations for transportation of radioactive materials must be justified in terms of cost and the need for improved safety and performance. The commenter added that some of the changes, including the additional technical complexity of the proposed regulations ( e.g., nuclide specific thresholds), are not warranted based on the history of performance in the transportation of radioactive materials. Another commenter noted several areas of incompatibility between DOT and NRC proposed rules. The commenter also suggested that NRC work with DOT to agree on a consistent approach in organizing the A 1 and A 2 values for international shipments in Table A-1. A third commenter noted that DOT has already issued a proposed rule, HM 232, which focuses on using the registration program to affect the enhancement and security of radioactive materials in transport. Response. NRC's goal is to harmonize our transportation regulations to be consistent with IAEA and DOT, while ensuring that the requirements adopted will benefit public health, safety, and the environment. The NRC has conducted an evaluation of the radionuclide-specific thresholds (the exemption values), including a regulatory analysis and an environmental assessment, and concluded that adoption of these values is warranted, in spite of the technical complexity. NRC has been working with the DOT. The NRC has completed a regulatory analysis that supports harmonization in terms of cost and regulatory efficiency. Comment. One commenter stated that NRC should use the latest medical knowledge from independent sources ( i.e., not IAEA or International Commission on Radiological Protection (ICRP) data) regarding the medical effects of radiation. Response. The NRC considers a variety of sources of information concerning the health effects attributed to exposure to ionizing radiation. Two primary sources of information are the National Research Council/National Academy of Sciences (NAS) and the United Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR). Both groups provide an independent and comprehensive evaluation of the health risks associated with radiation exposure. The NRC currently is sponsoring an NAS review of information from molecular, cellular, and animal studies of radiation, other environmental exposures, and epidemiologic studies to evaluate and update previous reviews of the health risks related to exposure to low-level ionizing radiation. These studies focus on the latest published information available. Comment. Several commenters questioned the credibility of the IAEA and the ICRP because these organizations are not publicly accountable. Three of the commenters further questioned the process of the NRC simply accepting what the IAEA does, noting that agencies in Europe have challenged ICRP assumptions. One of these commenters stated that regulated or potentially regulated bodies should be allowed more involvement in the IAEA decisionmaking process. Furthermore, the suggested lack of public involvement led one commenter to express a general lack of trust for these organizations and question the credibility of their conclusions. This lack of public involvement was at issue with another commenter who added that the proposal would only “make things easier for the transportation and nuclear industries at the expense of public health.” Response. The United States is represented at the IAEA for transportation issues through the DOT acting as Competent Authority (the official U.S. representative organization). The NRC consults with DOT on issues related to nuclear material transport. NRC disagrees with the statement that the NRC simply accepts what the IAEA does. When the NRC (and the DOT) seeks to amend its regulations to harmonize with IAEA's, it does so through a deliberate and open process via rulemaking. The public has been afforded in the past, and will continue to be afforded, the opportunity to comment on DOT's and NRC's proposed rulemakings. This effort can result in NRC regulations not matching the IAEA guidance. Further, the NRC does not “simply accept” the IAEA standards. In many instances, the NRC has chosen to implement regulations that differ from the IAEA's. Issues 7 and 11 of this final rule, discussed elsewhere in this SUPPLEMENTARY INFORMATION , are just two examples of where NRC has differed from the IAEA requirements by implementing more stringent requirements. Information on the IAEA and ICRP can be found at their respective Web sites: www.iaea.org and www.icrp.org. These Web sites provide background on each organization that should address the concerns about the credibility of each organization. Comment. One commenter stated that the burden of proof for departing from IAEA standards is shifted by the regulators to the regulated entities. Another commenter suggested that the burden of proof for rejecting the proposed regulatory changes is being shifted to citizens and stakeholders. Response. Both the NRC and DOT are participating members of the IAEA and have direct input to the development of new transportation standards. Before DOT or NRC proposes U.S. regulations for harmonization with IAEA standards, each agency completes a technical evaluation and makes a determination if each new standard should be adopted by the U.S. The public involvement process for rulemaking solicits stakeholders to suggest changes to proposed rule language or to suggest the rejection of a proposed regulatory change. With sufficient justification, public comments have resulted in modification to regulatory text. Comment. One commenter asked if either NRC standards or IAEA's could protect the public from “real world” problems. The commenter inquired how NRC accounts for the fact that a cask might burn for longer than existing standards require it to withstand fire. The commenter believed that such rationales were particularly relevant in light of recent incidents, such as the Baltimore Tunnel fire and the Arkansas River bridge accident. Response. The NRC notes the questions on how realistic the transportation standards established by the NRC and the IAEA are. Both NRC and IAEA standards require that cask designs be able to withstand hypothetical accident conditions. The conditions bound (or are more severe than) those conditions that would be expected in the vast majority of real world accidents and therefore provide protection for the cask designs. Additionally, the NRC has periodically revisited and evaluated the effects of actual accidents to look at the forces and the challenges that would be presented to casks in “real world” transportation accidents. For example, in response to the Baltimore Tunnel fire, the NRC staff has conducted two sets of independent analyses and has determined that the conditions that existed in the fire would not have caused a breech of a current spent fuel transportation cask design had it been located in the tunnel for the duration of the fire. Comment. One commenter stated that the timeline by which NRC would adopt IAEA requirements should be changed. The commenter also stated that the current 2-year cycle for changes is too frequent. Response. The timeline for adopting IAEA standards and the cycle for making changes at the IAEA are beyond the scope of this rulemaking. Comment. One commenter stated that the proposed rule might allow weakening of transportation cask safety testing and increase the risk of the release of radioactive materials during transportation accidents. Response. This concern is acknowledged, but the NRC does not believe that this rule weakens testing standards. Comment. One commenter stated that all radioactive shipments should be regulated and labeled so that transportation workers and emergency responders are aware of the risk. Response. The comments are acknowledged. DOT regulations include requirements for labels, markings, and placarding packages and conveyances of radioactive materials, and training of Hazmat workers. Existing and proposed regulations for the transportation of radioactive materials consider the potential risk to workers and emergency responders of exposure to these materials. The NRC believes the thresholds for regulation of the transportation of radioactive materials protect the health and safety of workers and emergency responders. Comment. One commenter pointed out that due to the increase in the number of nuclear shipments, the NRC and DOT must strengthen their standards to protect the millions of people, thousands of schools, and hundreds of hospitals residing directly along transportation routes. Response. The NRC routinely reevaluates the effectiveness of its regulations to ensure that it is meeting its mission to protect the public health and safety. In regulating safe and secure transport of spent nuclear fuel, the NRC has conducted risk studies to consider the fact that a large number of shipments might be made to a future geological repository using current generation cask designs. These studies have confirmed that the current NRC regulations are robust and protective of the public during transportation of spent fuel. Therefore even with an increase in the number of shipments, these shipments can be made safely in large numbers to a centrally located storage facility. Comment. On behalf of the nuclear industry, one commenter said that harmonization is logical in terms of cost and safety. Harmonized rules and uniform standards and criteria allow members of the nuclear industry to know how safe a package is, regardless of where it comes from. Because many other nations have already adopted many of these proposed rules, U.S. transporters are already required to meet these standards in many cases. The commenter also voiced support for exempting certain domestic shipments from these international regulations. Response. Harmonization with TS-R-1 should maintain the safety of shipments of radioactive materials while eliminating the need to satisfy two different regulatory requirements ( i.e., domestic versus international shipments). The NRC believes that by clarifying and simplifying shipping requirements, harmonization will help all who are involved in the transport of radioactive material to comply successfully with regulations. Comment. One commenter stated that there has already been much deliberation over the proposed regulations. He stated that his organization and the industry at large have been looking at these proposed changes for well over 10 years. Response. The comments are acknowledged. Comment. One commenter stated that harmonization is a “value neutral process” and isn't necessarily good or bad. Response. Harmonization can be viewed as a value neutral process, although the NRC believes that harmonizing domestic and international regulations generally improves efficiency and safety in the transport of radioactive material. NRC's proposed changes are based upon the careful evaluation of specific issues and provisions in TS-R-1. At this level, the NRC believes that the negative ( i.e., costs) or positive ( i.e., benefits) value of a particular change can be assessed effectively. These costs and benefits have been carefully evaluated in our decisionmaking process. Comment. Four commenters opposed harmonizing rules. One commenter opposed harmonization because it “appears to be occurring to satisfy demands of the nuclear industry and affected governmental bodies” to facilitate commerce, rather than in the interest of public safety. Another commenter noted that the primary objective of these changes should be to protect public health, safety, and the environment. Another commenter argued that harmonization should not be used as a justification for violating a country's sovereignty or a State's right to maintain stringent standards. The commenter said that U.S. rules were already harmonized before these proposed changes and that the authors of international regulations should not dictate U.S. regulations. The fact that other countries have adopted the IAEA regulations is not sufficient justification for the U.S. to adopt these regulations. The commenter agreed that some degree of harmonization makes sense but emphasized that the U.S. needs to maintain control over its own rules. Response. The IAEA periodically updates international regulations for the safe transport of radioactive material in response to advances in scientific knowledge and technical experience. These changes are implemented with the purpose of improving public safety, as well as facilitating commerce. The U.S. has substantial input into the IAEA development of these periodic revisions through official representation by the DOT. While the NRC aims to harmonize its regulations closely with those issued by the IAEA, NRC independently evaluates proposed changes in the interest of protecting public health, safety, and the environment. This rule reflects this extensive process; NRC routinely suggests adoption or partial adoption of certain provisions and nonadoption of others. Comment. Two commenters asked if NRC could quantifiably prove that harmonization is necessary. One asked if NRC's failure to comply with the IAEA regulations has disrupted commerce or jeopardized public safety, and whether members of the international community have accused the U.S. of disrupting commerce by not complying with these regulations. Response. DOT and NRC accomplish harmonization by adopting domestic rules that are compatible with international rules. DOT and NRC rules may differ from those of IAEA where it is necessary to reflect domestic practices. However, these differences are kept to a minimum because regulatory differences can lead to confusion and errors and can result in unsafe conditions or events. U.S. failure to comply with international safety regulations could easily result in disruption of U.S. participation in international radioactive material commerce, with no commensurate justifiable safety benefit, because other IAEA Member States are under no obligation to accept shipments that do not comply with international regulations. Comment. One commenter wanted to know how the IAEA drafted its regulations and statistics. The commenter questioned who the IAEA is and why NRC should accept its statistics. The commenter also asked how much input the American public has had on these regulations and noted that Congress and the public have previously rejected IAEA regulations. Response. The comments concerning the IAEA standards development process and U.S. citizen input to that process are both beyond the scope of this rulemaking. However, as noted in the public meetings held to obtain comments on the proposed rule, DOT is mandated by law to help formulate international transportation standards, and to ensure that domestic regulations are consistent with international standards to the degree deemed appropriate. The law permits DOT the flexibility to accept or reject certain of the international standards. The NRC/DOT evaluation of the IAEA standards has resulted in the two parallel sets of final rule changes. Rejection of an IAEA standard could be based on technical criteria as well as on public comment on proposed rules. The IAEA has Member States that develop standards as a collegial body, and the U.S. is one of those Member States. Comment. Several commenters urged NRC to improve its scientific understanding and basis for the proposed rulemaking. Two commenters suggested that NRC complete the comprehensive assessments of TS-R-1 and future IAEA standards, the Package Performance Study (PPS), and full-scale cask tests before proceeding with this rulemaking. A commenter stressed that ICRP does not represent the full range of scientific opinion on radiation and health and ignores concepts such as the bystander effect and synergism of radiation with other environmental contaminants. This commenter also stated that the exposure models used to justify certain exposure scenarios are inadequate. Response. The NRC acknowledges these comments and notes that NRC participates or monitors the work of major, national and international, scientific organizations in the fields of health physics and radiation protection. As such, NRC has access to the latest scientific advances. Moreover, the NRC has completed an assessment of TS-R-1 as part of the development of this rule. The PPS is a research project independent of this rulemaking. Also, see the following comment regarding the ICRP. Comment. Several commenters stated that the IAEA rulemaking process is not democratic, and their documents are not publicly available and were developed without public knowledge or input. One commenter suggested that the public should have had an opportunity to “comment on or otherwise participate in the earlier formation of the IAEA rules.” Another commenter proposed that the NRC act as an intermediary between public opinion and IAEA by improving communications with the public and regulated bodies, providing advanced notice of rulemakings, and receiving comments on proposed rules. Response. The NRC acknowledges the comments about the IAEA rulemaking process, the ICRP representation of scientific opinion, and the observation on NRC's role as intermediary between the American public and the IAEA, but each of these comments brings up issues that are beyond the scope of the proposed rulemaking. Therefore, no changes were made to this rulemaking. The NRC notes that the IAEA has begun to discuss ways to foster public participation in its standards development process. Comment. Several commenters stated that IAEA and ICRP regulations should not dictate domestic U.S.-based regulations. Two commenters stated that IAEA does not necessarily consider the risk-informed, performance-based standards that are important to rulemaking in the U.S. The commenters added that the NRC must recognize that while IAEA standards generally have good technical bases, they are consensus standards that do not necessarily consider the risk-informed, performance-based aspects of regulations that we have developed in the U.S. Response. The NRC acknowledges the comment about IAEA and ICRP regulations dictating U.S. based regulations and notes that this comment is not accurate and is considered to be an opinion. The NRC is a participating member of both the IAEA and the ICRP, and neither body dictates to the NRC what regulations or standards must be adopted. As a participant, the NRC suggests transportation standard changes and as such, the NRC both proposes and comments on the language of new standards. This participation permits the NRC to infuse its ideas on risk-informed regulations, when possible. Comment. The effort to harmonize regulations was supported by several commenters. One commenter spoke for Agreement States and expressed support for harmonizing regulations. Two others explained that the benefit of harmonization would be consistent national and international regulations and improved safety, yet U.S. regulators (and regulations) would retain the legal authority to act when and as necessary. Another commenter emphasized that given how new information is found all the time and the IAEA is on a 2-year standards revision schedule, it does not make sense to hold back harmonizing U.S. standards with international standards pending the outcome of any studies. Response. The NRC believes that its effort to promote regulatory harmonization will maintain and/or improve safety, increase regulatory efficiency and effectiveness, as well as reduce unnecessary regulatory burden. The NRC's aim is to harmonize its regulations with IAEA regulations by adopting many of the provisions in TS-R-1. However, the NRC does not propose wholesale adoption of TS-R-1, but only when adoption provides the best opportunity to maintain and/or improve public safety, health, and the environment. Regulatory Analysis (RA) and Environmental Assessment (EA) Comment. Several commenters found the RA to be deficient in various aspects. One commenter asserted that updated quantitative data should be included in the RA that would include the following information: the number of exempt and nonexempt packages; the number of exempt and nonexempt shipments; the average number of packages per shipment; and the detailed information on curie counts by shipment categories. The commenter noted that all stakeholders are affected by these deficiencies, notably public information groups and Western States. Two commenters focused on the RA's cost analysis with one stating that no changes should be made without a cost analysis and the other stating that the RA had not adequately considered the cost of the proposed rule. The second of these commenters stated that specific dose information, calculations, and information regarding the impact of the new regulations should have been included in the draft RA and EA. They found the RA to be deficient because of its failure to recognize likely impacts of the changes to the double containment of plutonium regulations, particularly regarding the agreement between the Western Governors' Association, the individual Western States, and the Department of Energy (DOE) for a system of additional transportation safeguards. Response. Quantitative data was requested throughout the rulemaking process. These requests were made during the development of the proposed rule, and a request was again made in the proposed rule. Where this information was available, it was used in the development of NRC's proposed positions. To the extent that information was provided, it has been considered in the development of NRC's final position. Comment. One commenter asserted that the proposed rule is a major Federal action, thus deserving of a full Environmental Impact Statement (EIS). The commenter also stated that an EIS dating from 1977 and a study dating from 1985 do not suffice as adequate analysis of the proposed rule's impact, due to changes “in population, in land use, in the transportation system, in laws, in issues of national security.” Response. NRC acknowledges this comment and notes that it has prepared an EA. Based on the results of the EA, the NRC staff has concluded that this rule is not a major Federal action requiring an EIS. As noted in the proposed rule, NRC is interested in receiving additional data, and to the extent that the data was received, it was included in the analyses leading up to the final rule. Comment. One commenter said that the EA and the rulemaking are too carefully tied together. The commenter said that this fact precludes NRC from actually finding an environmental impact from the rule. Response. The draft EA is a study that is required as part of a rulemaking to ensure that the potential impacts to public health and safety and the environment are adequately evaluated as part of the decisionmaking process. As such, the rule and the EA are necessarily “tied together.” Comment. Two commenters found the EA to be deficient in various aspects. One commenter stated that specific dose information, calculations, and information regarding the impact of the new regulations should have been included in the draft EA and RA. A commenter believes that the EA and RA lack the following pieces of information: the number of exempt and nonexempt packages; the number of exempt and nonexempt shipments; the average number of packages per shipment; and the detailed information on curie counts by shipment categories. One commenter believes that the EA should include transportation scenarios, updated data rather than 1982 data, and a quantitative analysis along with a qualitative analysis. The NRC was criticized for a portion of the EA (page 43), which first identifies information necessary to make a risk-informed decision on the proposed regulation and then discusses the lack of information in the EA. The commenters noted a discrepancy in NRC's efforts, particularly the number of NRC staff and resources devoted to this rulemaking for the past 2 years versus the lack of resources devoted to updating the 1982 data. They stated that the costs associated with the Type C package changes were not included in the EA and that process irradiators are shipping sources equaling about 50 million curies, much greater than the curie count listed in the proposed rulemaking. Response. The NRC acknowledge the comments regarding the lack of information in some portions of the draft RA and EA. The draft EA and RA were developed based on the best information available to the NRC at the time. Moreover, NRC solicited in the proposed rule FRN, additional information on the costs and benefits of the proposed requirements, including the Type C package changes. All the information received has been considered in NRC's final decision. The NRC staff notes that the majority of the proposed changes are such that the specific dose information and calculations are not required to determine the appropriateness of adopting or not adopting the change being considered. Comment. One commenter expressed concerns about NRC's findings of “no significant impact” on radionuclide-specific activity values for a number of issues. The commenter requested that more detailed information be provided “on how many and which radionuclide levels will rise or fall” as a result of proposed changes. The commenter also asked the NRC to define its use of “significantly” and to explain how it determined the level of “risk.” Response. Detailed information on the identity of radionuclides whose specific activity values rise or fall relative to the previous definition of 70 Bq/g (0.002 μCi/g) may be determined by inspection of Table A-2. The context for “significantly” is provided in the background section. NRC has used estimated dose to the public, as determined through the use of radionuclide transport scenarios, as an indicator of risk. State Regulations Comment. One commenter asked if these new regulations would threaten a State's right to regulate radioactive materials that NRC has deregulated. Two commenters stated opposition to the proposed rule due to their belief that it would lower standards. The first commenter stated that the proposed rule would override State and local laws that are stricter than Federal regulations while the second commenter stated that the proposed rule would reduce environmental protection. Four commenters added that “harmonization” with international law was a poor and ultimately insufficient justification to weaken U.S. regulations. Response. State and local governments do not have authority to set regulations for the transportation of radioactive materials that are stricter or more stringent than those of the Federal government. In accordance with section 274b of the Atomic Energy Act, as amended, Agreement States programs must be compatible with those of the NRC for the regulation of certain radioactive materials to assume authority for the regulations of these materials from the NRC. Because of this, the Commission developed the “Policy Statement on Adequacy and Compatibility of Agreement State Programs” which became effective on September 3, 1997 (62 FR 46517). One of the provisions of this Policy Statement is that an Agreement State should adopt program elements that apply to activities that have direct and significant effects in multiple jurisdictions' elements in an essentially identical manner as those of the NRC ( see definition of Compatibility Category B in section VI of this notice). This is needed to eliminate any conflicts, duplications, gaps, or other conditions that would jeopardize an orderly pattern in the regulation of radioactive materials on a nationwide basis. Those part 71 requirements applicable to materials regulated by Agreement States are designated as Category B and must be adopted in an essentially identical manner as those of the NRC because they apply to activities that have direct and significant effects in multiple jurisdictions. Terrorism Concerns Comment. Six commenters expressed concern with the increased threat of terrorism and its impact on radioactive material transport. One commenter suggested that shipping standards be strengthened due to both an increased threat of terrorist attacks and the decline in rail, highway, air, and waterway infrastructure. Two commenters stated that they were concerned that many of the new regulations would make transported radioactive material more vulnerable to terrorist attacks and wanted to know how NRC anticipated responding to the threat of these attacks. Three commenters mentioned that the threat of terrorism should be taken into account when changing container regulations, with one commenter highlighting double versus single containment of plutonium. The final commenter stated that the NRC should reconsider the scope of the proposed rule due to the “altered circumstances of our nation's vulnerability to terrorist attack.” The commenter also suggested that the proposed rule be withdrawn and that the NRC “recalculate the full adverse consequences and the full long-term financial, health, and environmental costs to the public, the nation, and the economy of worst case terrorist actions.” The commenter also stated that in a time of increased national security threats, the safety of containerization must be maximized. Response. As discussed on the NRC's Web site ( see www.nrc.gov/what-we-do/safeguards/911/faq.html ), most shipments of radioactive materials involve materials such as pharmaceuticals, ores, low-level radioactive waste, and consumer products containing radionuclides ( e.g. , watches, smoke detectors). A variety of Federal and State government agencies regulate the shipment of radioactive materials. High-level nuclear waste materials, such as spent nuclear fuel, are transported in very heavy, robust containers called “casks.” Over the past 30 years, approximately 1300 shipments of commercially generated spent fuel have been made throughout the U.S. without any radiological releases to the environment or harm to the public. Federal regulations provide for rigorous standards for design and construction of shipment casks to ensure safe and secure transport of their hazardous contents. Casks must meet extremely demanding standards to ensure their integrity in severe accident environments. Therefore, the design of casks would make any radioactive release extremely unlikely. After September 11, 2001, the NRC issued advisories to licensees to increase security measures to further protect the transportation of specific types of radioactive materials, including spent fuel shipments. Additional measures have been imposed on licensees shipping specific quantities of radioactive material. Comment. Another commenter, who lives near a route proposed for shipping nuclear waste across the country, recommended that NRC strengthen radioactive transport regulations. One commenter opposed the adoption of new transport regulations that reduce the protection to the public from transporting nuclear wastes. Response. The NRC believes that the regulations contained in part 71 adequately protect public health and safety. The changes being adopted will not result in any undue increase in risk to public health, safety, or the environment. Comment. Several commenters were concerned that the proposed regulations may increase vulnerability to terrorist threats using radioactive materials. A commenter believes that labeling radioactive materials could aid terrorists by identifying the packages as radioactive, while another commenter stated that shipments with or without labels provided potential terrorists with the materials for a dirty bomb. Another commenter requested that NRC put protective measures into place at ports and to guard all nuclear shipments with U.S. military forces. One commenter stated that nuclear shipments should be transported at off-peak hours while all side roads, tunnels, bridges, overpasses, railroad crossings, access to exit ramps, etc., should be secured before the transport vehicle arrives, and that NRC should create a “vehicle-free” buffer zone ahead and behind the shipment. This same commenter advocated FBI background checks on all transporters, drivers, and crew workers involved with nuclear transport. Two commenters asserted that all new rules should be mindful to the threat of terrorism, which would be superior to considering terrorism in separate rules. Response. The NRC acknowledges these comments and notes that NRC has taken immediate regulatory actions to address the potential for terrorist activities; these include issuing orders and advisories to its spent fuel licensees prior to initiating rulemaking which takes a longer time, and initiating shipment vulnerability studies. Also, the NRC will make the necessary rule changes, based on these studies, as appropriate. Moreover, the NRC staff notes that several of the comments above were addressed in recent regulations (March and May, 2003), which were published jointly by the Department of Homeland Security and the DOT requiring shippers and carriers to submit security plans and requiring background checks on drivers. Adequacy of NRC Regulations and Rulemaking Process Comment. Three commenters believe that the NRC should better account for low-level radiation. One commenter stated that NRC should use the latest medical knowledge from independent sources ( i.e. , not IAEA or ICRP data) regarding the medical effects of radiation. Another commenter stated that low-level radiation could cause cell death, cancer, genetic mutations, leukemia, birth defects, and reproductive, immune, and endocrine system disorders. This commenter added that long-term exposure to low levels of ionizing radiation could be more dangerous than short-term exposure to high levels. Another commenter, who was similarly concerned with low dose and low dose-rate radiation, stated that “arguments of nuclear industry proponents that new information need not be considered is invalid and since the NRC's legal mandate is to protect the public's health and safety” the NRC needs to consider “cautionary information that is now available in the peer reviewed literature.” The commenter suggested that NRC not focus on the “standard man” but instead focus on the “most susceptible portions of the population—ova, embryo, fetus, rapidly growing young child, elderly, and those with impaired health” when drafting regulations. Lastly, the commenter implied that NRC should attempt to “assess and incorporate impacts of additive exposures to other forms of life and to ecosystems” as well as the impacts associated with “an individual recipient of the combinations of and synergies among radiation and other contaminants to which people are exposed.” Response. As discussed on the NRC's Web site ( see http://www.nrc.gov/reading-rm/doc-collections/fact-sheets/bio-effects-radiation.html , radiation may kill cells, induce genetic effects, and induce cancer at high doses and high dose rates. However, for low levels of radiation exposure at low dose exposure rates, health effects are so small they may not be detected. No birth defects or genetic disorders among the children born to atomic bomb survivors from Hiroshima and Nagasaki have been observed at low doses of radiation, i.e. , < 25 rad (Chapter 6, “Other Somatic and Fetal Effects,” of Beir V, Health Effects of Exposure to Low Levels of Ionizing Radiation ; National Research Council, 1990). Consequently, few if any similar effects are expected from exposure to low doses of ionizing radiation. Moreover, there is no epidemiology data, published in peer reviewed journals, to support the concern expressed by the commenter that long-term exposure to low levels of radiation may be more dangerous than short-term exposures to high levels. Humans have evolved in a world constantly exposed to low levels of ionizing radiation. The average radiation exposure in the U.S. from natural sources is 3.0 mSv (300 mrem) per year. Although radiation can have health effects at high doses and dose rates, for low levels of radiation exposure at low dose exposure rates, the incidence of biological effects is so small that it may not be detected. For example, information developed by the Health Physics Society suggests that the incidence of health effects, if they exist below 10,000 mrem (100 mSv), is too small to be observed. People living in areas having high levels of background radiation—above 10 mSv (1,000 mrem) per year, such as Denver, Colorado, have shown no adverse health effects. The NRC actively and continually monitors research programs and reports concerning the health effects of ionizing radiation exposure. NRC staff monitors the Low Dose and Low Dose Rate Research Program sponsored by the Department of Energy (DOE). The research project is designed to better understand the biological responses of molecules, cells, tissues, organs, and organisms to low doses of radiation. NRC also is co-funding a review of the Biological Effects of Ionizing Radiation (BEIR) by the National Research Council. The BEIR committee will also review and evaluate molecular, cellular, and animal exposure data and human epidemiologic studies to evaluate the health risks related to exposure to low-level ionizing radiation. Both groups provide a comprehensive evaluation of the health risks associated with radiation exposure. Finally, existing regulatory guidance suggests that protection of individuals (humans) is also protective of the environment. IAEA Technical Report Series No. 332 (Effects of Ionizing Radiation on Plants and Animals at Levels Implied by Current Radiation Protection Standards) suggests that, in most cases, the environment is being protected by protecting humans. Individuals in occupational or public areas may be exposed to radiation and chemical exposure which result from materials present in these areas. The NRC, however, has no regulatory authority over any of the materials present other than source, byproduct, or special nuclear material. In many situations, exposures to chemicals and non-NRC regulated materials are under the purview of the U.S. Environmental Protection Agency (EPA). Comment. Seven commenters opposed the proposed rule because of increased exposure, danger to public health, and increased public health risk. Response. The NRC disagrees that the proposed rulemaking will result in any significant increase in exposure, endangerment to public health, or increase in health risk. See earlier comment responses for further details. Comment. One commenter stated that U.S. agencies have not adequately represented public opinion regarding transportation safety. The commenter was concerned that the number of irradiated fuel and plutonium shipments in the nation will increase as the proposed regulations weaken container safety standards. Response. The DOT and NRC represent the United States before the IAEA, DOT as the U.S. Competent Authority supported by the NRC. Both agencies are aware of public opinion regarding transportation safety in the United States. The NRC disagrees with the comment that U.S. agencies have not adequately represented public opinion. Additionally, NRC and DOT prepare their rules in compliance with Administrative Procedure Act (APA) requirements. The APA requires that public comments be requested, considered, and addressed before a final rule is adopted unless there are exigent reasons to bypass the public comment process. Although the number of irradiated fuel and plutonium shipments in the future may increase, the number of shipments to be made is independent of this final rule. Lastly, the comment that the regulation weakens transportation container safety standards is a statement of opinion without supporting data or information. Comment. One commenter suggested that NRC staff needs to address fully any comments submitted by the public, even when the NRC might consider these comments beyond the scope of the proposed rule. Response. Although NRC is careful to address all comments with the scope of the rulemaking, there are instances when a comment is sufficiently outside the scope of a proposed action that it need not be addressed. NRC resources need to be used to address issues related to the rulemaking for efficiency and effectiveness. Comment. One commenter stated that the proposed rule did not specifically incorporate “issues to improve the protective adequacy of the regulations” that were raised by the public during meetings held in 2000. The commenter stated that “changes that were adopted in response to public comments in 2000 must be specified in a revised Proposed Rule.” The commenter also asked that further public meetings be held before DOT and NRC proceed with further revisions of the transportation regulations. Response. The current rule stems from NRC's scoping efforts in 2000, and no rule changes were adopted by the Commission at that time. For this proposed rulemaking, public meetings were held in Chicago, IL, as well as in Rockville, MD (as previously noted). NRC accepted and included all comments received, even those received after the July 29, 2002, deadline. For these reasons, the NRC believes its proposed rulemaking meets the intent of conducting an “enhanced public participation process.” Comment. Eleven commenters requested an extension to the comment period. One commenter said that the proposed rule is written in a manner difficult for the public and even watchdog groups to understand. Because the proposal would affect large portions of the general public by dramatically changing the standards of radioactive transport, the commenter urged the NRC to extend the comment period. Two commenters suggested that the NRC extend the comment period 180 additional days beyond the July 29, 2002, deadline to allow both the public and the NRC more time for further consideration. Commenters added that the proposed rule was not urgent and required further analysis and research. Finally, one commenter stated that the proposed rule's July 29, 2002, deadline for receipt of public comments would prevent it from accounting for the impact of Yucca Mountain. The commenter suggested that a 1- or 2-month rulemaking extension would be beneficial. Response. The NRC believes the 90-day public comment period was of sufficient length, especially in view of the availability of the proposed rule on the Secretary of the Commission's Web site for over a year ( i.e. , the Commission decided to make the proposed rule available to the public in March 2001, while it was under consideration). Therefore, the public had the opportunity to comment prior to the official comment period. Moreover, while not required to do so, the NRC chose to accept and consider comments received after the July 29, 2002, deadline. Further, as part of the NRC public participation process, NRC held two open meetings accessible to the public at which the NRC answered questions on the proposed rule and accepted comments. As part of the proposed rule, the NRC solicited additional information from the public which was considered in the development of the final rule. Comment. One commenter suggested that the NRC separate the comment period for the EA and RA from the comment period for the proposed rule. Response. The commenter's suggestion is noted but is not feasible to implement because the proposed rule and its supporting RA and EA must be considered concurrently within the rulemaking proceeding. Comment. One commenter asked if there is any systematic process by which the NRC has performed or will perform a cost-benefit analysis of these proposed regulations. Response. Whenever the NRC pursues a cost-benefit analysis (otherwise known as a regulatory analysis), the NRC works diligently to ensure that monetized, quantitative, and qualitative data are included. These data are studied to avoid including faulty and/or misleading data. The draft regulatory analysis in NUREG/CR-6713 has been revised to take into account the quantitative and qualitative data contained in the public comments on the proposed rule. Comment. Two commenters asked for clarification of the proposed rulemaking's scope in light of the May 10, 2002, letter from Commission Chairman Richard A. Meserve. Response. Former Chairman Meserve's May 10, 2002, letter to Senator Richard Durban provides information on questions posed by the Senator on transportation of spent fuel and nuclear waste to the proposed repository at Yucca Mountain, Nevada. The letter provides information on the NRC's certification process of cask designs, the safety record of spent fuel casks, and the NRC's authority with respect to transportation of radioactive materials and its relationship with DOT and DOE. The issues raised by this letter do not affect the amendments to part 71. Comment. One commenter asked if the NRC was aware that, on February 23, 2002, Chicago Mayor Richard M. Daley and 17 other mayors signed a letter to President Bush that expressed concerns about nuclear waste transportation. The commenter also made reference to the fire in the Baltimore tunnel and wondered about safety if the fire had involved radioactive materials. Response. The NRC searched its Agency Wide Document Access and Management System (ADAMS), and no record was found for this letter; however, the NRC is aware of concerns about spent nuclear fuel transportation issues that have been voiced by public officials. There has been significant interest in the Baltimore tunnel fire that occurred on July 18, 2001, by State and local officials, and the impact that such a fire might have had on a shipment of spent nuclear fuel, had such a shipment been in the tunnel during the time of the fire. In response to the Baltimore Tunnel fire, the staff has conducted two sets of independent analyses and has determined that the conditions that existed in the fire would not have caused a breech of a spent fuel transportation cask of recent design vintage had it been located in the tunnel for the duration of the fire. Comment. One commenter stated that changes in the scientific community's understanding of radiation injury would affect the risk assessments and other aspects of the proposed rule. The commenter said that both the DOE Biological Effects Division's and NASA's study of the impacts of low dose radiation impacts may require that NRC reconsider its current standards. Response. The DOE is funding a 10-year Low Dose Radiation Research Program to understand the biological responses of molecules, cells, tissues, organs, and organisms to low doses of radiation. Using traditional toxicological and epidemiological approaches, scientists have not been able to demonstrate an increase in disease incidence at levels of exposure close to background. Using new techniques and instrumentation to measure biological and genetic changes following low doses of radiation, it is believed that a better understanding will be developed concerning how radiation affects cells and molecules and provide a more complete scientific input for decisions about the adequacy of current radiation standards. These data are reviewed by other groups like NAS and UNSCEAR to provide an independent review of this health effects information. NRC reviews the programs and data being generated by the DOE and NASA-sponsored research as well as the reports published by the NAS and UNSCEAR. All of these data sources are used by the NRC for estimating radiological risk, establishing protection and safety standards, and regulating radioactive materials. Comment. Several commenters expressed concern and doubts about the data used to develop the proposed rule and the information the NRC provided to support its proposal. One commenter urged NRC to ensure that the adopted rule represents a risk-informed, performance-based approach. Two commenters criticized the proposed rule for not accounting for an expected increase in radioactive shipments. Given such an increase, one commenter criticized the NRC for using 20-year old data to justify rule changes that will reduce public safety. This commenter claimed that the data was out-of-date, inaccurate, not independently verified, and did not consider the concepts of radiation's synergistic effects when combined with other toxins. Another commenter argued that DOT and NRC should use more current data and future projections including the expected increases in actual nuclear shipments to estimate the impacts of the rule change. Realistic scenarios and updated data must be used to project doses and thus estimate the impacts of the proposed rule's changes, rather than relying on old data, ICRP, and reliance on computer model scenarios (or simply stating the lack of data). In addition, DOT and NRC should include the expected increases in actual nuclear shipments. Another commenter expressed doubt that the proposed rule's technical benefits are legitimate and stated that these benefits are not supported in the draft EA. One commenter stated that the NRC should wait to adopt any new regulations until there is more information available about the costs and benefits of such regulations. Response. The IAEA developed its latest standards through a cooperative process where experts from member nations proposed and supported changes to the previous version of the safety standards. The NRC has provided detail on the justification for the proposed changes in the statements of consideration for this rulemaking. The commenter did not provide sufficient detail on which data were of concern for NRC to further address. The comment that the NRC is relying on 20-year old data for justification of its regulations is unfounded. The NRC has completed risk studies related to the safety of transportation as recently as 2001 and is currently engaged in a research program that will include the full scale testing of casks, to demonstrate the robust nature of certified cask designs. The comments about the quality of data and benefits are considered to be the opinion of the commenter and were not substantiated. Lastly, the NRC notes that a cost-benefit analysis has already been conducted and is reflected in the NRC's RA. Comment. Four commenters expressed concern that there is inadequate quantitative data to support the risk-based approach of the proposed rule and that some of the provisions are based on incorrect or outdated information. Two commenters were specifically concerned that DOE and some commercial nuclear facilities are negligent in keeping radiation exposure and release records. These commenters questioned how NRC data was gathered and noted that a failure to keep accurate records constrains NRC's ability to determine whether the proposed harmonization is economically justifiable. Furthermore, these commenters added that lack of records undermines the NRC claim that hundreds of thousands of radioactive material shipments are conducted safely every year. Response. See response to the previous comment. Also, the NRC notes that the commenter's statements regarding DOE and commercial facilities' negligence is an opinion and was not supported by factual evidence. Comment. Three commenters stated that pertinent documents and data were not readily available or were too difficult to access for the general public. One commenter requested improved public access to “sources of codes and IAEA documents that were cited by reference in the draft” rule. Response. The NRC staff worked diligently to ensure that rulemaking documents, including all supporting documents, were available either electronically, over the internet, or in hard-copy upon the public's request in a timely fashion. This includes facilitating public access to the internet site of the publisher of IAEA documents in the U.S. Comment. Four commenters stated that the NRC should finish the PPS and consider its results before finalizing the proposed rulemaking as well as the rules governing irradiated fuel containers. Another commenter requested that the PPS be completed and thoroughly analyzed before this rulemaking is carried out because the current design requirements for irradiated fuel containers are inadequate and should be improved. Response. The NRC believes that shipments of spent fuel in the U.S. are safe using the current regulations and programs. This belief is based on the NRC's confidence in the shipping containers that it certifies, ongoing research in transportation safety, and compliance with safety regulations and the conditions of certificates that have resulted in an outstanding transport safety record. Thus, an established system of regulatory controls protects every U.S. shipment of spent fuel from commercial reactors. The NRC sponsored PPS is part of an ongoing confirmatory research program to reassess risks as shipment technologies change and analytical capabilities improve. Comment. Three commenters urged the NRC to require more stringent testing of transport packages in real-world (not computer-modeled) testing. Response. NRC regulations permit certifications through testing, analyses, comparison to similar approved designs, or combinations of these methods. A full scale testing is not necessary for the NRC to achieve confidence that a design satisfies the regulatory tests, as long as the analyses are based on sound and proven analytic techniques. Comment. One commenter suggested that the NRC ensure that the economic value of these regulations is not skewed. That is, the commenter does not want the needs of one particular industry to shape the regulations, when the regulations could have a greater impact on a different industry. Response. The overall value or impact of the proposed changes results from the interaction of several influencing factors. It is the net effect of the influencing factors that governs whether an overall value or impact would result for several different attributes ( i.e. , different industries or the public). Similarly, a single regulatory option could affect licensee costs in multiple ways. A value-impact analysis, such as was undertaken as part of this rulemaking effort, quantifies these net effects and calculates the overall values and impacts of each regulatory option. A decision on which regulatory option is recommended takes into account the overall values and impacts of the rulemaking. Comment. One commenter stressed that when the NRC has decision makers review public comments, the NRC staff should look at primary documents instead of summary documents. The commenter cited NUREG/CR-6711 as an example where the regulator runs the risk of having decision makers read summaries of public comments without understanding the underlying context and content. Response. In our decisionmaking process, the NRC did not rely on a summary document to support the development of the proposed rule. NRC used primary documents to fully understand the underlying context and content of the technical information. The summary documents the commenter refers to were developed to provide the public with a comprehensive, yet condensed, version of the underlying information. Further, these underlying documents were also made available to the public on the NRC Web site during the rulemaking process. Comment. One commenter asked which countries have already adopted the proposed guidelines. Response. The IAEA has conducted a survey that provides the status (as of July 1, 2003) of each Member State's plans for implementing TS-R-1. Based on that survey, many States have already implemented the new requirements of TS-R-1 ( e.g. , European Commission, Germany, and Australia). Other States have indicated that they are actively implementing these requirements and intend to finalize implementation by the end of 2003. No State indicated that it would not adopt these standards. This survey is available at http://www-rasanet.iaea.org/downloads/radiation-safety/MSResponsesJuly1 2003.pdf Comment. One commenter requested clarification on NRC assumptions for future radioactive materials transportation. Specifically, the commenter wanted to know whether NRC is assuming the amounts will increase or remain consistent with past levels. Response. The NRC's draft RA and EA relied on existing information to determine the future impacts of the proposed changes. NRC solicited information on the costs and benefits for each of the proposed changes as part of the proposed rule. The NRC considered available information on future radioactive material shipments in its decisionmaking process. Information that was received as part of the public comment process was considered in developing NRC's final position. The NRC staff conducted some sensitivity studies, see for example Comparison of A 1 and A 2 new and old values in the EA, Table A-1, Appendix A. Comment. Three commenters opposed weakening regulations that would reduce the public safety and health through new definitions or accepted concentration values. One commenter worried that the proposed rule would weaken regulatory control, allowing increased quantities of radioactive materials and wastes “into the lives of individual citizens without their knowledge or approval,” thus violating “the most fundamental premises of radiation protection.” Response. The NRC acknowledges the concerns but believes that the rule continues to protect the public's health and safety in a risk-informed manner. Comment. One commenter particularly opposed NRC and DOE studies, including the EIS to review alternative policies for disposal and recycling of radioactive metals. The commenter requested that the NRC maintain stringent controls on all materials being recycled, disposed, or otherwise reused. Two commenters expressed opposition to the proposed rule due to a belief that the proposed rule would deregulate radioactive wastes and materials and allow the deliberate dispersal of radioactive materials into raw materials and products that are used by the public and are available on the market. Response. The NRC acknowledges the commenters' references to DOE and NRC studies related to the disposal and recycling of radioactive metals. This rule is not related to the referenced studies. Comment. One commenter expressed concern that NRC's proposed regulations could increase the variety of materials that are regulated as “radioactive” for transportation purposes. Response. The rule does not expand the scope of regulated radioactive material. Comment. One commenter expressed concern that the proposed rule enables commercial and military nuclear industries to “revive and expand, thereby generating ever more wastes to be stored, transported and ultimately * * * sequestered from the biosystem.” Response. The comment is beyond the scope of this rulemaking. Proposed Yucca Mountain Facility Comment . One commenter expressed opposition to sending shipments of nuclear materials to the proposed Yucca Mountain facility. Response . Potential shipments to the proposed geologic repository at Yucca Mountain are beyond the scope of this rulemaking. Comment . Two commenters raised issues related to the possible approval of the Yucca Mountain site. One commenter expressed concern about the safety of dry casks. The commenter asked if the NRC was aware of the accident at the Point Beach Nuclear Plant in Wisconsin on May 28, 1996, and how similar the dry casks that will ship radionuclides to Yucca Mountain will be to the casks used at Point Beach. The commenter noted that once one buries a dry cask, one cannot change it; therefore, the U.S. will have to be sure that it uses safe casks. The second commenter urged the NRC to consider the transportation issues associated with the possible approval of the Yucca Mountain site as the NRC makes rules pertaining to the packaging and transportation of radioactive materials. Response . The Nuclear Waste Policy Act (NWPA) requires DOE to use casks certified by NRC for transport to Yucca Mountain, if licensed. Transport casks are generally not the same as storage or disposal casks. Issues regarding the licensing of the Yucca Mountain site and the safety of spent fuel storage or disposal casks are beyond the scope of the proposed rulemaking. The NRC believes compliance with the regulations in part 71 provides for safe transport package designs. Comment . Three commenters expressed belief that increases in future shipments have not been adequately considered in the rulemaking. The first commenter stated that these regulations could have important implications for the shipment of high-level radioactive waste. The commenter asked if NRC had considered the financial impact of the opening of the Yucca Mountain facility before proposing the regulations. Response . This comment is primarily focused on future shipments to Yucca Mountain. The Commission has not received any application relative to the Yucca Mountain site, and a final decision has not been made on opening the site itself. Any conclusion made now by the NRC on future shipments would be purely speculative. Moreover, the commenter did not specify which aspect of the proposed rule would have a significant bearing on the Yucca Mountain facility. The NRC did not identify where major impacts would result, none were identified that would impact spent fuel shipments. Furthermore, the existing regulations pertaining to spent fuel have been in effect for a significant time and have resulted in more than 1300 spent fuel shipments being conducted without any negative impacts to public health and safety. Comment . Two commenters asked how NRC factored the possible approval of the Yucca Mountain repository into our rulemaking. One commenter urged NRC to seriously consider the likely increase of radioactive material transportation in Illinois, Michigan, and Wisconsin that will occur if the Yucca Mountain repository is approved. The commenter also provided data from DOE's Yucca Mountain EIS on projected transportation volume through Illinois. Response . The comments are acknowledged. However, they are beyond the scope of this rulemaking. As part of the rulemaking process, NRC solicited information on the costs and benefits, as well as other pertinent data, on the proposed changes. NRC appreciates the commenter's submission of data related to projected transportation volumes of high-level waste. The NRC believes compliance with the regulations in part 71 provides for safe transport package designs. Miscellaneous (including comments to DOT) Comment . One commenter opposed any use of radioactive materials entirely. Response . This comment is beyond the scope of the rulemaking. This rule deals solely with regulations that govern the transportation of certain types of radioactive materials and does not address issues related to the use of radioactive materials in commerce. Comment . One commenter included a comment letter that was previously submitted in September 2000, discussing all of the issues in this rulemaking. The letter was resubmitted because the commenter believes that the NRC did not respond to the comments previously and might have lost the original comment letter. The commenter also included several diagrams and an article entitled “New Developments in Accident Resistant Shipping Containers for Radioactive Materials” by J. A. Sisler. This article discusses the safety tests required for shipping containers. Response . The current proposal stems from NRC's scoping meetings held in August and September 2000, to solicit public comments on the part 71 Issues Paper. NRC accepted all verbal and written comments received at the meetings or later in a letter form and considered these comments in developing the proposed rule. Comment . One commenter stated that the public's opinion is that nuclear power and weapons should remain sequestered from the environment and the public for as long as they remain hazardous. Response . The comment is beyond the scope of the rulemaking. This rule deals solely with regulations that govern the transportation of certain types of radioactive materials and does not address the use of nuclear power or weapons. Comment . One commenter expressed a general distrust of business and urged NRC to consider recent cases of dishonesty in business when formulating regulations. Response . The comment is beyond the scope of this rulemaking. Comment . One commenter expressed concern that inaccurate reporting, inspection failures, and faulty equipment all occur in the nuclear transport industry and may contribute to mishaps in transit. Response . The NRC is aware of the potential for accidents in transporting nuclear material and has considered the accident history of nuclear transportation in estimating the risks of shipping. The NRC believes that this rule provides adequate protection of the public and workers in normal transport conditions and in accident conditions. Comment . One commenter recommended that all radioactive shipments be tracked, labeled, and publicly reported, including shipments being made in secret without the consent of the American public. Response . The NRC acknowledges the commenter's suggestion about tracking, labeling, and reporting shipments. Current regulations include requirements for labels and markings for packages that contain radioactive materials. There are notification requirements for NRC licensees applicable to shipments of spent nuclear fuel. Current NRC/DOT requirements for tracking and labeling radioactive shipments provide adequate protection of public health and safety. Comment . Several commenters were concerned about the public reporting requirements pertaining to the shipping of radioactive materials. Two commenters believe that NRC should publicly report all radioactive shipments. Response . The NRC has regulations in 10 CFR part 73 (Physical Protection of Plants and Materials) that deal with the reporting of shipments of spent fuel nuclear fuel. This rule deals only with part 71; therefore, these comments are beyond the scope of this rulemaking. Comment . Several commenters expressed concern with the tracking and labeling aspects of the proposed rule. Two commenters urged the NRC to track, label, and publicly report all radioactive shipments. One commenter believes that the words “radioactive materials” should not be removed from shipping placards because personnel and volunteers understand the plain English warning better than technical language. This commenter also suggested that the warnings be written in several languages. In addition, one commenter stated that the standard symbol, the black and yellow “windmill” for radiation, should adorn all containers. Response . Tracking and labeling shipments are part of the responsibility of the shipper of the licensed material in accordance with NRC and DOT regulations. Reporting all radioactive shipments would be an administrative burden with minimal benefit. The NRC's regulations do require a shipper to provide advance notification of a shipment of spent nuclear fuel to both the NRC and to the Governor or designee of a State through which the shipment would be passing. The information is considered safeguards information and cannot be released to the public until after a shipment has been completed. Comment . One commenter expressed support for NRC's acknowledging DOT's responsibility to ensure the safe shipment of spent nuclear fuel. Response . The comment is acknowledged. No further response is required. Comment . One commenter requested a clarification of the current status of DOT's regulations for international shipments regarding exempt quantities and concentrations. Response . This request has been forwarded to DOT for consideration. The commenter should refer to DOT's proposed rule found at 67 FR 21328 dated April 30, 2002. Comment . One commenter expressed concern with how the proposed regulations fit into the hierarchy of Federal, State, and local regulations. The commenter noted that DOT regulations expressly preempt and supersede State and local regulations. Response . The State regulations augment the overall national program for the protection of public health and safety of citizens from any hazards incident to the transportation of radioactive materials. States usually adopt the Federal transportation regulations by reference. The combined efforts of DOT, NRC, and the Agreement States assure that the applicable Federal regulations are observed with respect to packaging and transportation of radioactive materials on a nationwide basis. This is accomplished through DOT, NRC, and State and local government inspection and enforcement efforts. Comment . One commenter expressed concern that the DOT definition of “radioactive material” is now defined as “any material having a specific activity greater than 70 Bq per gram (0.002 micro curie per gram).” According to the commenter, the effect of this new definition would be to enable much more radioactivity to be exempt, thus allowing more radioactive material to move unregulated in commerce. Response . This referenced definition change also exists in the NRC final rule. As described in the background section of this rule, NRC has analyzed the impact on dose to the public from changing the definition of “radioactive material” from the current definition 70 Bq/g (0.002 μCi/g) for all radionuclides to radionuclide-specific exemption values. After considering transport scenarios, NRC concluded that the new radionuclide-specific definition would result in an overall reduction in dose to the public when compared to the current definition. Comment . One commenter noted that, in Table 1, the listings for Th (nat) and U (nat) (68 FR 21482) do not refer to footnote b. Because this is inconsistent with the text of the preamble, the commenter concluded that it is a typographical error that should be corrected. Response . The comment is acknowledged and was considered in developing the final rule. Comment . One commenter urged the NRC to consider “the relationships between and among the exposures associated with these packaging, container, and transportation regulations and all other sources of radiation exposures,” to protect the public from “adverse impacts on their health and genetic integrity.” Response . The comment is acknowledged and has been considered in developing the final rule. Comment . Three commenters expressed concern with the role of State and local governments. One commenter believes that certain States are already burdened with unusually high concentrations of hazardous and radioactive materials transport. Another commenter asked about “the status of non-Agreement States with respect to compatibility” and also wanted further “explanation of the extent to which a State or Agreement State may deviate from NRC program elements, definitions, and standards.” One commenter stated that county sheriffs and the proper State officials should be notified in advance of spent nuclear fuel shipments scheduled to pass through their jurisdictions. Response . It is NRC practice to seek input and comments from State and local governments on any NRC proposed rules. For example, in December 2000, the NRC staff forwarded the part 71 proposed rule to the Agreement States for comment before sending the rule to the Commission. Once the rule is published for public comments, NRC considers comments from all State and local governments, and as such, they play an important role in the NRC regulatory process. State officials designated by the Governor are notified in advance of spent nuclear fuel shipments made by NRC licensees, which pass through their respective States. Comment . Several commenters criticized the proposed rule for acquiescing to the desires of the nuclear and radiopharmaceutical industries to weaken transport regulations at the expense of increased public risk. Response . The proposed rule was developed to maintain compatibility with the IAEA transportation standards as well as to issue other NRC-initiated changes. Part 71 has been revised twice in the past 20 years to stay compatible with IAEA regulations. The risk to the public from transportation of radioactive materials were considered in the development of the NRC regulations. Comment . Two commenters expressed concern over implications for worker safety. These commenters asked if workers would be protected from and informed of leaks and whether there is sufficient money to pay lawsuit damages. They stated that exposure to the transport vehicle itself should not exceed 10 millirems/year, and all crew compartments should be heavily shielded to reduce exposure. One commenter then asserted that workers should be trained to handle radioactive materials and informed of the risks involved. Response . NRC radioactive material transportation regulations have always been issued and enforced to protect the worker and the public health and safety. When shippers of radioactive material follow these regulations, they are taking the protective measures called for in NRC (and DOT) regulations to protect the crew and public. The NRC and DOT regulations require worker training. Comment . Several commenters believe that the proposed regulations increased public risk and weakened protection of public health. One commenter stated that additional independent oversight of the transport casks should be conducted regarding quality control to determine whether they are adequate for cross-country transport. This commenter also believes that the testing criteria for containers should be more demanding and require real-world conditions. Another commenter stated that nuclear shipments should be transported at off-peak hours and also supported the creation of a “vehicle-free” buffer zone ahead and behind the shipment. Response . The commenters did not specify how the proposed rulemaking would increase public risk and weaken protection of public health. When NRC developed the proposed rule, potential impacts were carefully considered. NRC does not believe that any part of the proposal will result in a significant impact on public health and safety. NRC's quality assurance programs and inspections determine when additional oversight is warranted. The request for additional and more demanding testing is not specific; it does not specify how and why particular testing procedures are inadequate. These procedures have been carefully verified by NRC to ensure adequate safety. NRC does not support the commenter's suggestion to transport at “off-peak” hours and use a buffer zone as an NRC safety requirement. There is no safety basis to justify restricting travel only to off-peak hours, and creating (and enforcing) buffer zones could result in greater traffic impacts and safety issues. Moreover, using these restrictions is not warranted based on the more than 1300 shipments without incident. Comment . One commenter urged the NRC to prohibit transport of long-lived spent nuclear fuel via air or via barge across large waterways. The commenter also urged NRC to disallow the transport of such fuel in combination with people, animals, or plants. Response . Existing NRC and DOT regulations establish requirements that must be met for safe shipment of spent nuclear fuel by transportation modes ( i.e. , truck, barge, or air). The commenter's second recommendation is noted, but it is beyond the scope of the proposed rule. Comment . One commenter stated that dumping radioactive material into oceans or landfills and incineration of such materials should never be allowed. Response . The comment is acknowledged. However, it is beyond the scope of this rulemaking, and therefore no further response is required. Comment . One commenter suggested that NRC, in concert with other agencies, identify and recover formerly regulated nuclear materials that have been deregulated or have escaped from control in the past. Response . This comment is beyond the scope of this rule. Comment . One commenter requested an explanation of how NRC's official proposal on the changes in packaging and transporting of radioactive materials would affect industrial radiology. Response . Generally, industrial radiography cameras are designed to meet NRC requirements for Type B transportation packages. Of the 11 IAEA adoption issues and the 8 NRC-initiated issues, none have a significant impact upon the transport package design requirements for radiography cameras. Comment . One commenter expressed support for compatibility among the Agreement States. This commenter indicated that it is appropriate for States to have the ability to develop materials necessary for intrastate shipments. However, for interstate shipments, the commenter stated that it is necessary for one State to be compatible with the rest of the country for the country to be compatible with the world. Response . NRC notes that the commenter's views are consistent with the Commission's Policy Statement on the Adequacy and Compatibility of Agreement State Programs, which became effective on September 3, 1997 (62 FR 46517). Comment. Several commenters urged NRC to improve its scientific understanding and bases for the proposed rulemaking. Two commenters suggested that NRC complete the comprehensive assessments of TS-R-1 and future IAEA standards, the PPS, and real cask tests before proceeding with this rulemaking. Response. NRC believes it has an adequate technical basis to make determinations on the adoption of regulatory changes to address the issues that are the subject of this rulemaking. The ongoing PPS is beyond the scope of this rulemaking. III. Discussion This section is structured to present and discuss each issue separately (with cross references as appropriate). Each issue has four parts: Summary of NRC Final Rule, Affected Sections, Background, and Analysis of Public Comments on the Proposed Rule. A. TS-R-1 Compatibility Issues Issue 1. Changing Part 71 to the International System of Units (SI) Only Summary of NRC Final Rule. The NRC has decided to continue using the dual-unit system (SI units and customary units) in part 71. This will not conflict with TS-R-1, which uses SI units only, because TS-R-1 does not specifically prohibit the use of a dual-unit system. We have decided not to change part 71 to use SI units only nor to require NRC licensees and holders and applicants for a Certificate-of-Compliance (CoC) to use SI units only because doing so will conflict with NRC's Metrication Policy (61 FR 31169; June 19, 1996) which allows a dual-use system. The NRC did not make metrication mandatory because no corresponding improvement in public health and safety would result; rather, costs would be incurred without benefit. Moreover, as noted in the proposed rule (67 FR 21395-21396), 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. Affected Sections. None (not adopted). 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 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 unit was permissible on labels and shipping papers (paragraphs 442 and 447). The NRC Metrication Policy 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 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), and American Society of Mechanical Engineers (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: 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. Analysis of Public Comments on the Proposed Rule A review of the comments and the NRC staff's responses for this issue follows: Comment. Eight commenters stated they appreciated the NRC's decision to maintain both the international and the familiar system of becquerels and curies and sieverts and rem. Response. No response is necessary. Issue 2. Radionuclide Exemption Values Summary of NRC Final Rule. The final rule adopts, in §§ 71.14, 71.88 and Appendix A, Table A-2, the radionuclide activity concentration values and consignment activity limits in TS-R-1 for the exemption from regulatory requirements for the shipment or carriage of certain radioactive low-level materials. In addition, the final rule provides an exemption from regulatory requirements for natural material and ores containing naturally occurring radionuclides that are not intended to be processed for use of these radionuclides, provided the activity concentration of the material does not exceed 10 times the applicable values. These amendments conform part 71 with TS-R-1 and with DOT's parallel IAEA compatibility rulemaking for CFR 49. 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 value for all radionuclides for defining a material as radioactive for transportation purposes (a uniform activity concentration basis) and that a more rigorous technical approach would be to base radionuclide exemptions on a uniform dose basis. The values and limits in TS-R-1, and adopted in Appendix A, Table A-2, establish a consistent dose-based model for minimizing public exposure. Overall, NRC's analysis shows that the new system would result in lower actual doses to the public than the uniform activity concentration basis system. NRC's regulatory analysis indicated that adopting the radionuclide-specific exemption values contained in TS-R-1 is appropriate from a safety, regulatory, and cost perspective. Moreover, the final rule assures continued consistency between domestic and international regulations for the basic definition of radioactive material in transport. Affected Sections. Sections 71.14, 71.88, and Appendix A. Background. The DOT previously used an activity concentration threshold of 70 Bq/g (0.002 μCi/g) for defining a material as radioactive for transportation purposes. DOT regulations applied to all materials with activity concentrations that exceeded this value. Materials were exempt from DOT's transportation regulations if the activity concentration was equal to or below this value. The 70-Bq/g (0.002-μCi/g) activity concentration value was applied collectively for all radionuclides present in a material. In § 71.10, the NRC used the same activity concentration threshold as a means of determining if a radioactive material was subject to the requirements of part 71. Materials were exempt from the transportation requirements in part 71 if the activity concentration was equal to or below this value. Although the materials may be exempt from any additional transportation requirements under part 71, it is important to note that 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. Basically, the radionuclide exemption values mean that licensed low radioactivity materials are not required to be handled as hazardous materials while they are being transported. These exemption values do not mean that these materials are released from other regulatory controls, including the controls that apply to the disposal or release of radioactive 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 activity concentration basis. By 1994, the IAEA had developed Safety Series No. 115 (also known as Basic Safety Standard, or BSS) and a set of principles for determining when exemption from regulation was appropriate. One exemption criterion was 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 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. 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. A comparison of the transportation scenario doses resulting from the single (70 Bq/g (0.002 μCi/g)) activity concentration value and the radionuclide-specific activity concentration values shows that the radionuclide activity concentration values reduced the variability in doses that were likely to result from exempt transport activities. The basis for the exemption values indicates that materials with very low hazards can be safely exempted from the transportation regulations ( see draft Advisory Material for the Regulations for the Safe Transport of Radioactive Material, TS-G-1.1, paragraphs 107.5 and 401.3). 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. Some of the lower activity concentration values might include naturally occurring radioactive material (NORM). As an example, ores may contain NORM. Regarding the transport of NORM, one petroleum industry representative stated that 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.” Analysis of Public Comments on the Proposed Rule A review of the comments and the NRC staff's responses for this issue follows: Comment. One commenter opposed the reuse of radioactive materials in other products, arguing that this is not based on sound science, but on commercial judgment. Several commenters expressed general objections to the proposal to exempt certain amounts of radionuclides from transportation regulatory control and urged NRC to help prevent more radioactive waste from being deregulated. Seven commenters stated that adopting these exemptions would remove a significant barrier to the purposeful release of radioactive materials from nuclear power and weapons production into raw materials that can be used to make daily items ( e.g. , hip replacements, braces, and toothbrushes) that come into contact with members of the public. Another commenter stated that the exempted levels could potentially provide a back door to recycle and release of radioactive material. One commenter said that the NRC's stated objectives to facilitate nuclear transportation and harmonize international standards should not supersede the NRC's mandate to protect public health and safety. The commenter also stated that the proposed regulations do not do enough to protect public health. The commenter opposed the technically significant motive for adopting exemption values, which is to facilitate radioactive “release” and “recycling” or dispersal of nuclear waste into daily commerce and household items. One commenter stated that NRC regulations should not treat radioactive materials like nonradioactive materials. Two other commenters criticized the proposed regulations for treating radioactive substances as if they were not radioactively contaminated. Response. The transportation exemption values do not establish thresholds for the release of radioactive material to unlicensed parties or to the environment. They do not relieve the recipient from regulations that apply to the use or release of that material. Also, the transportation regulations do not authorize the possession of licensed material (§ 71.0(c)). Thus, no unauthorized party may receive or possess radioactive material just because the material is exempted from transportation requirements. Radioactive material transported under the rule remains subject to separate regulatory safety requirements regarding possession, use, transfer, and disposal. Comment. One commenter stated that the use of “or” in proposed § 71.14(a)(2) (67 FR 21448) suggests that there is no consignment limit if the exempt activity concentration limits are not exceeded. NRC was asked to replace “or” by “and” to prevent deliberate dilution of radioactive material to obtain exemption from transport regulations. Response. The comment is correct in that the consignment activity limit does not apply to materials that do not exceed the exempt activity concentration. Under the final rule, the transport regulations apply only to radioactive material for which both the activity concentration for an exempt material and the activity limit for an exempt consignment are exceeded, so the use of “or” in the regulatory text is correct. When describing materials that are subject to the regulations, “and” is the correct term; when describing materials that are not subject to the regulations, “or” is the correct term. Because § 71.14 defines materials that are not subject to the regulations, “or” is the correct term. Material consignments that exceed the exempt activity concentration, but not the exempt consignment limit, are not regulated in transport due to the small quantity of material being transported. Material consignments that exceed the exempt consignment limit, but not the exempt activity concentration, are not regulated in transport due to the low radioactivity concentration of the material being transported. The NRC has no information to support the notion that radioactive material is diluted to obtain exemption from transport regulations. The NRC does not propose any regulatory action in this regard. Comment. One commenter expressed concern both that the proposed rule would exempt radionuclide values at various levels and that an international body created these exemption levels. Response. The activity concentration exemption values do vary by radionuclide. However, the doses to the public estimated to occur from using these values under the transport scenarios are low. The U.S. participated in assessing the dose impacts from the use of the exemption values in transport. Comment. Another commenter asked if it is really necessary for NRC to adopt the entire IAEA rule to accomplish its goals. Response. There are a number of specific goals associated with this rulemaking, one of which is harmonization of NRC regulations with IAEA's TS-R-1 and DOT regulations. NRC is not adopting TS-R-1 in its entirety in this rulemaking. However, with respect to revising exemption values, the NRC staff believes adoption of the exemption values from TS-R-1 is warranted to maintain consistency between domestic and international regulations. Comment. One commenter asked if the NRC told DOT that the American public has rejected these proposed standards three times in the past decade, and if DOT has advised IAEA of these objections. The commenter said that if the IAEA has not been informed of the American public's resistance to these regulations, NRC needs to inform the agency (DOT and IAEA) immediately. Response. The NRC acknowledges this comment, including both the NRC's and DOT's earlier opposition to the IAEA proposed exemption values. This rule is the first time that IAEA exemption values are adopted and are being carried out for maintaining compatibility with international transportation regulations. Comment. One commenter asked about the amount of money being spent regulating levels below the exemption values. The commenter asked if more money would be spent attempting to verify the proposed exemption values than would be saved by deregulating them. The commenter wanted to know if there is any guarantee that money saved by deregulating levels below the exemption values will be spent on improving public safety in other areas. Response. The NRC believes the benefits of the exemption values will outweigh the costs. NRC analyses lead the NRC staff to believe that the increase in regulatory efficiency between regulatory agencies and the facilitation of international shipments make the exemption values advantageous overall. Further, as part of this rulemaking, NRC specifically requested information on the costs and benefits of the proposed changes. To the extent this information was received, it was considered in the development of NRC's position. Lastly, it is beyond the scope of this rulemaking to guarantee that any money saved will be spent on improving public safety elsewhere. Comment. One commenter suggested that the NRC could not determine costs or savings from the proposed radionuclide exemption values, in part because the NRC does not know what amounts will be exempted. The commenter also explained that although NRC could attempt to do projections based on the current industry, NRC could not know what amounts would be exempted in the future. Response. The NRC fully realizes the difficulties associated with predicting the impacts of implementing the exemption values. The NRC also agrees that it is difficult to predict what amounts would be exempted under this final rule, just as it is difficult to assess the amount of material exempted under the current regulations. However, a large majority of commercial radioactive materials are shipped in highly purified forms that far exceed the exemption levels. NRC expects this would continue to be the case under the exemption values. For all of these reasons, the NRC staff explicitly asked for data on the anticipated impacts of the proposed rule. The NRC staff used these data to aid decisionmaking. In general, the NRC expects that the increase in regulatory efficiency among regulatory agencies and the facilitation of international shipments will outweigh any increased costs of shipments resulting from the changes in the exemption values. Comment. One commenter requested that a cost-benefit analysis be done to account for both the proposed rule's complexity and its enforcement difficulties. The commenter notes that no cost-benefit analysis had been done on this issue and that the NRC chose it subjectively. Response. The draft regulatory analysis considered the benefits and costs associated with adoption of the radionuclide exemption values from TS-R-1 using the best available information. In addition, the NRC decided to adopt the dose-based exemption values because the NRC believes these values would actually reduce exposure in transport by establishing a consistent dose-based model for minimizing public exposure. This benefit is in addition to the expected harmonization and financial benefits. NRC disagrees with the commenter's assertion that the exemption values were chosen subjectively. NRC used the best available information and gathered as much information as possible from the public, the regulated community, and outside experts. The purpose of this rulemaking, with its public meetings and public comment period, is to ensure that all affected parties have adequate opportunity to register their comments and provide supporting materials to justify their position (and thus better influence the development of NRC's final position). Comment. Another commenter stated that the technical benefits of the proposed rule do not outweigh the associated costs and efforts. Response. Because NRC staff are unclear what the commenter means by “technical benefits,” NRC cannot specifically respond to this comment. Overall, NRC believes that the benefits that will accrue with adoption of exemption values from TS-R-1 ( e.g. , harmonization with other regulatory agencies and facilitation of international shipments) will outweigh the costs ( e.g. , administrative changes, determining whether packages are exempt, and regulating previously exempt packages). Comment. One commenter opposed the proposed exemption values because they were not derived directly and did not directly involve public input or a cost-benefit analysis. Response. A preliminary RA that evaluated possible costs and benefits was conducted as part of the development of this rule. Additional information obtained during the rulemaking process was considered in determining NRC's final position on adopting the TS-R-1 exemption values. Comment. One commenter stated that, although the revised limits are not expected to create any significant burden to the Naval Nuclear Propulsion Program, use of the new limits could create a cumbersome work practice for some shipments. All low-level shipments that are currently exempt will require a detailed evaluation to ensure that activity concentrations for each radionuclide are acceptable. For example, thoriated tungsten weld rods and soil from site excavations would require individual isotope analyses at an additional expense. The commenter stated that the current 70-Bq/g activity concentration limit for domestic shipments should be retained. Response. The comment is consistent with others from the shipping community ( i.e. , the radionuclide activity concentration and activity exemption values are likely to be more cumbersome to work with but do not pose an excessive burden). The NRC agrees that expenses may be involved in achieving compliance with these values but notes that expenses are also associated with determining compliance with the current 70-Bq/g (0.002-μCi/g) value. Most shipments of radioactive materials involve materials that have been processed to concentrate radioactivity. These materials are known by shippers to greatly exceed the exemption values, and are packaged and transported in accordance with the radioactive material transporation safety regulations. Thus the exemption values are irrelevant to the majority of radioactive material shipments, such as most shipments in the Naval Nuclear Propulsion Program and most shipments in industry as well. The exemption values are relevant to shipments of low activity concentration. For these shipments, shippers will need to establish either by process knowledge or analysis whether a shipment exceeds the exemption values and is regulated in transport as a radioactive hazardous material, or does not exceed the exemption values and may be shipped as non-hazardous material (regular freight). Most shipments that minimally exceed the exemption values are likely to be transported as limited quantities, which would impose a minimal regulatory burden on shippers. Overall, NRC believes that the benefits that will accrue with adoption of exemption values from TS-R-1 ( e.g. , harmonization with other regulatory agencies and facilitation of international shipments) will outweigh the costs ( e.g. , administrative changes, determining whether packages are exempt, and regulating previously exempt packages). Comment. Two commenters stated that the proposed rule would increase industry's regulatory burden. In particular, the NRC was told that the proposed rule is too conservative and would unnecessarily burden industry, particularly in the case of bulk shipments of contaminated materials. The proposed exemption thresholds would increase worker exposure to radioactive materials. Response. NRC acknowledges that the exemption values impose some new complexity and economic burden on industry. However, NRC believes that the increase in costs will be minimal. The NRC believes that the exemption values represent a good balance between economic and public health interests. From an economic perspective, the increased costs of the exemption values are outweighed by the benefits of conforming to other regulatory agencies and facilitating international shipments. NRC staff recognizes that preshipment requirements under the exemption values may increase some low-level exposures, but the NRC still expects that the shift to a consistent set of dose-based exemption values will minimize the potential dose to transport workers. Comment. One commenter stated that, although cost reduction was one incentive for the rule, the proposed rule as written was so complicated that enforcement costs would rise. Response. NRC acknowledges the comment and, as previously discussed, NRC believes that any additional enforcement or other costs will be minimal due to the anticipated benefits of having only one set of shipping requirements, as well as the cost savings that would result from moving some materials outside the scope of transport regulation. Comment. Two commenters stated that the proposed regulations failed to properly implement IAEA exemption values regarding naturally occurring radioactive material, which would dramatically expand the universe of regulated materials and increase the burden on the regulated community. One commenter stated that other agencies, such as the Occupational Safety and Health Administration (OSHA), afford adequate protection from naturally occurring radioactive materials for workers and the public, and therefore NRC should not enter this regulatory arena. This commenter also stated that the proposed exemption values would also lead to a conflict with the Resources Conservation and Recovery Act (RCRA), which stipulates that waste disposal sites may not accept radioactive materials of more than 70 Bq/g. Another commenter specifically noted that the NRC has not implemented the exemption provisions for phosphate ore and fertilizer; zirconium ores; titanium minerals; tungsten ores and concentrates; vanadium ores; yttrium and rare earths; bauxite and alumina; coal and coal fly ash. The commenter urged NRC to consider the activity concentration of the parent nuclide in determining exemption values. Response. Section 71.14(a)(1) provides the same exemption for low level materials ( e.g. , natural materials and ores) that IAEA provides in TS-R-1 paragraph 107(e). The exemption multiple for activity concentration (10 times the values listed in 10 CFR part 71, Table A-2) applies to natural material and ores containing naturally occurring radionuclides which are not intended to be processed for use of these radionuclides. If the materials identified in the comment meet the definition and are not being processed to use radionuclides, the exemption multiple would apply. Thus, the burden indicated by the commenter would not occur. The activity concentration for exempt material applies to each radionuclide listed in Table A-2. For radionuclides in secular equilibrium with progeny, the listed activity concentration applies to the listed radionuclide (as parent), and was determined considering the contribution from progeny. Table A-2, as published on April 30, 2002; 67 FR 21472, contains several typographical errors, including the omission of the reference to footnote (b) for the U (nat) and Th (nat) radionuclides. These errors have been corrected in this final rule. Comment. One commenter was concerned that the exemption values in TS-R-1 could result in the unnecessary regulation of certain materials that are currently exempt from NRC regulation under § 40.13. The commenter urged [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A04-35. Public record. Not legal advice.