# Hazardous Materials Regulations; Compatibility With the Regulations of the International Atomic Energy Agency > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A02-8143 ## Record - **Collection:** Federal Register - **Document type:** Proposed Rule - **Published:** April 30, 2002 - **Citation:** 67 FR 21328 ## Text DEPARTMENT OF TRANSPORTATION Research and Special Programs Administration 49 CFR Parts 171, 172, 173, 174, 175, 176, 177 and 178 [Docket No. RSPA-99-6283 (HM-230)] RIN 2137-AD40 Hazardous Materials Regulations; Compatibility With the Regulations of the International Atomic Energy Agency AGENCY: Research and Special Programs Administration (RSPA), DOT. ACTION: Notice of proposed rulemaking (NPRM). SUMMARY: RSPA proposes to amend requirements in the Hazardous Materials Regulations (HMR) pertaining to the transportation of radioactive materials based on changes contained in the International Atomic Energy Agency (IAEA) publication, entitled “IAEA Safety Standards Series: Regulations for the Safe Transport of Radioactive Material,” 1996 Edition, No. TS-R-1. The purpose of this rulemaking initiative is to harmonize requirements of the HMR with international standards for radioactive materials as well as to promulgate other DOT-initiated requirements. DATES: Comments must be received by July 29, 2002. ADDRESSES: Address comments to the Dockets Unit, U.S. Department of Transportation, Room PL 401, 400 Seventh St., SW., Washington, DC 20590-0001. Comments should identify the docket number RSPA-99-6283 (HM-230) and be submitted in two copies. Persons wishing to receive confirmation of receipt of their comments should include a self-addressed stamped postcard. You may also submit comments to the docket electronically by accessing the Dockets Management System website at “ http://dms.dot.gov .” Click on “Help & Information” to obtain instructions for filing the document electronically. The Dockets Unit is located on the Plaza Level of the Nassif Building at the U.S. Department of Transportation at the above address. Public dockets may be reviewed between the hours of 9:00 a.m. and 5:00 p.m., Monday through Friday, except on Federal holidays. Internet users may access all comments received by the U.S. Department of Transportation at http://dms.dot.gov . An electronic copy of the document may be downloaded using a modem and suitable communications software from the Government Printing Office Electronic Bulletin Board Service at (202) 512-1661. FOR FURTHER INFORMATION CONTACT: Dr. Fred D. Ferate II, Office of Hazardous Materials Technology, (202) 366-4545, or Charles E. Betts, Office of Hazardous Materials Standards, (202) 366-8553; RSPA, U.S. Department of Transportation, 400 Seventh Street SW., Washington, DC 20590-0001. SUPPLEMENTARY INFORMATION: CONTENTS I. Background. II.Proposed Changes in this NPRM A. Summary A. Issue Discussion Issue 1: Nuclide-Specific Exemption Values Issue 2: Naturally Occurring Radioactive Materials Issue 3: Changes in A 1 and A 2 Values Issue 4: Communication Changes Issue 5: Low Specific Activity (LSA) materials and Surface Contaminated Objects (SCO) Issue 6: Uranium Hexafluoride (UF 6 ) Issue 7: Air Transport Requirements Issue 8: Fissile Material Package and Transport Requirements Issue 9: Transitional Requirements Issue 10: Additional TS-R-1 Change III. Section-By-Section Review IV. Regulatory Analyses and Notices A. Executive Order 12866 and DOT Regulatory Polices and Procedures B. Executive Order 13132 C. Executive Order 13175 D. Regulatory Flexibility Act E. Paperwork Reduction Act F. Regulation Identifier Number (RIN) G. Unfunded Mandates Reform Act H. Environmental Assessment I. Background In 1958, at the request of the Economic and Social Council of the United Nations, the IAEA undertook the development of international regulations for the safe transportation of radioactive materials. The initial regulations published by the IAEA in 1961 were recommended to member states as the basis for national regulations and for application to international transportation. Most nations have since adopted the IAEA regulations as a basis for regulations governing the transportation of radioactive materials. In 1967, after extensive revisions, the IAEA published its regulations entitled “Regulations for the Safe Transport of Radioactive Material, Safety Series No. 6.” In October 1968, DOT published amendments to the Hazardous Materials Regulations (Title 49, Code of Federal Regulations, Parts 171-180; HMR) for radioactive materials which were in substantial conformance with the 1967 IAEA regulations (Docket HM-2, 33 FR 14918). Based on work done by participants from member states, including the U.S., the IAEA issued two major updates of Safety Series No. 6 in 1973 and 1985. On March 10, 1983, the Research and Special Programs Administration (RSPA, we) published a final rule (Docket HM-169, 48 FR 10218), bringing the HMR requirements relating to the transportation of radioactive materials into alignment with the 1973 IAEA regulations. On September 28, 1995, we published a final rule (Docket HM-169A, 60 FR 50291) that revised the radioactive materials requirements in the HMR to align them with the 1985 revision of Safety Series No. 6. In each case, we coordinated the HMR revisions with the Nuclear Regulatory Commission (NRC), which concurrently revised 10 CFR part 71, and in each case these revisions made the United States radioactive material transport regulations compatible with those of most other industrialized nations. In 1996, the IAEA revised and issued IAEA Safety Standards Series No. ST-1, (“ST-1”). IAEA subsequently revised ST-1 in June 2000 to include minor editorial changes and renamed it “TS-R-1.” In this Notice, we use the nomenclature “TS-R-1” to refer to the 1996 IAEA “Regulations for the Safe Transport of Radioactive Material.” Copies of TS-R-1 may be obtained from the U. S. distributor, Bernan Associates, 4611-F Assembly Drive, Lanham, MD 20706-4391, telephone (301) 459-7666. As in past rulemakings to incorporate updates of the international regulations into the HMR, we are working in close cooperation with NRC in the development of this rulemaking. Currently, DOT and NRC jointly regulate the transportation of radioactive material in the United States in accordance with a July 2, 1979, Memorandum of Understanding (MOU; 44 FR 38690). In accordance with this MOU (a copy of which has been placed in the docket of this rulemaking): 1. DOT regulates both shippers and carriers and has issued: • Packaging requirements; • Communication requirements for: —Shipping paper contents, —Package labeling and marking requirements, and —Vehicle placarding requirements; • Training and emergency response requirements; and • Highway routing requirements. 2. NRC requires its licensees to satisfy requirements to protect public health and safety and to assure the common defense and security, and: • Certifies Type B and fissile material package designs and approves package quality assurance programs for its licensees; • Provides technical support to DOT and works with DOT to ensure consistency with respect to the transportation of radioactive materials; and • Conducts inspections of licensees in accordance with DOT requirements. This rulemaking is being coordinated by RSPA with NRC to ensure that consistent regulatory standards are maintained for radioactive material transportation regulations, and to ensure coordinated publication of rules by both agencies. This NPRM addresses only the areas over which DOT has jurisdiction as defined in the MOU. Comments on non-DOT issues or on DOT issues not in the scope of this rulemaking will not be addressed in this NPRM. Comments responding to the NRC's parallel NPRM should be submitted directly to the NRC through its rulemaking process. On December 28, 1999 (64 FR 72633), we published an advance notice of proposed rulemaking (ANPRM) requesting comments from interested persons concerning the extent to which differences between the HMR and the IAEA publication TS-R-1 should be considered in proposing changes to the HMR. We identified a partial list of TS-R-1 requirements being considered for incorporation in the HMR. We invited interested persons to review and comment on any or all of the requirements in TS-R-1 that differ from current HMR requirements and identify related issues we should address in the NPRM. In response to the ANPRM, we received approximately 80 written comments from trade associations, hazardous materials consulting firms, chemical manufacturers, radiopharmaceutical manufacturers, shippers and carriers of hazardous materials, and private citizens. In addition, we 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 the HMR. Based on this comparison and comments received from the ANPRM, we identified ten issues where increased compatibility between the HMR and TS-R-1 appears to be desirable. On February 1, 2000, we published a final rule under Docket HM-215D (66 FR 8644), in which we adopted the International Maritime Dangerous Goods (IMDG) Code, 2000 edition, including Amendment 30-00 and the UN Recommendations on the Transport of Dangerous Goods, Eleventh Revised Edition (1999), both of which authorize the use of TS-R-1. We published a final rule on June 21, 2001 (66 FR 33315), which provided that TS-R-1 could be used, as an alternative to the HMR, for international shipments or radioactive materials. Additionally, we retained Safety Series No. 6 with the same restrictions. Under this final rule, domestic shipments remain subject to the HMR requirements that are based on Safety Series No. 6. This NPRM will address the adoption of TS-R-1 for domestic use. This rulemaking will not propose any security related changes to the HMR. As a result of the terrorist incidents of September 11, 2001, and subsequent threats related to biological materials, we are reviewing the HMR to determine if additional requirements are necessary to assure the security of hazardous materials in transportation. We initiated a rulemaking project to address security issues related to the transportation of hazardous materials by all modes. We are examining hazard communication, shipping documentation, training, and other requirements to determine if rulemaking action is necessary. II. Proposed Changes in This NPRM A. Summary We have identified ten major issues concerning adoption of TS-R-1 requirements, which are discussed in detail in Section B of this preamble. In addition, Section B also contains the analysis of comments. For incorporation into the HMR this NPRM proposes to: • Adopt the nuclide-specific exemption activity concentrations and the nuclide-specific exemption consignment activities listed in TS-R-1 to assure continued consistency between domestic and international regulations for the basic definition of radioactive material; • Provide an exception in the HMR that certain naturally occurring radioactive materials would not be subject to the requirements of the HMR so long as their specific activities do not exceed 10 times the activity concentration exemption values; • Incorporate the TS-R-1 changes in the A1 and A2 values into the HMR; • Adopt the new proper shipping names and UN identification numbers, except for those referring to Type C packages, to fissile LSA material and to fissile SCOs; • Require, if customary units are used, that the appropriate quantity and customary units be placed within parentheses positioned after the original quantity expressed in the International System of Units (SI units); • Adopt the use of the Criticality Safety Index (CSI) to refer to what was formerly the criticality control transport index, and to restrict the use of the concept of transport index (TI) to a number derived purely from the maximum radiation level at one meter from the package; • Require the new fissile label be placed on each fissile material package, and that the CSI for that package be noted on the fissile label; • Adopt the requirement that excepted packages be marked with the UN identification number, that industrial packagings be marked with the package type, and that Type IP-2 and IP-3 industrial packages and Type A packages be marked with the international vehicle registration code of the country of origin of packaging design; • Remove some former requirements which would become redundant upon adoption of the new proper shipping names, such as the requirement that the shipping description contain the words “Radioactive Material” unless those words are included in the proper shipping name; • Remove plutonium-238 from the definition of fissile material. Remove the reference to Pu-238 in the list of fissile radionuclides for which the weight in grams or kilograms may be listed instead of or in addition to the activity, in the shipping paper or radioactive label description of the radioactive contents of a package; • Adopt a definition of contamination, and include an authority to transport unpackaged LSA material and SCO, and an authority to use qualified tank containers, freight containers and metal intermediate bulk containers as industrial packagings, types 2 and 3 (IP-2 and IP-3); • Adopt the new class of LSA-I material, consisting of radioactive material in which the activity is distributed throughout and the estimated average specific activity does not exceed 30 times the activity concentration exemption level, and to remove the present category referring to mill tailings, contaminated earth, concrete, rubble, other debris, and activated material that is essentially uniformly distributed, with specific activity not exceeding 10- 6 A 2 /g. • Incorporate the TS-R-1 changes for packagings containing more than 0.1 kg of UF 6 ; • Authorize the use of the 1993 edition of ISO 7195 as an alternative to ANSI N14.1, to require UF 6 packagings to meet the pressure, drop and thermal test requirements, to prohibit the use of pressure relief devices, and to certify the packagings in accordance with TS-R-1 requirements; • Revise § 173.453 to reflect the NRC “fissile material exemption provisions,” to remove the definition of “fissile material, controlled shipment,” and to revise § 173.457 and § 173.459 to remove the references to “fissile material, controlled shipment” and to base requirements for non-exclusive use and exclusive use shipments of fissile material packages on TS-R-1 package and conveyance CSI limits; • Accept the IAEA transitional requirements and begin the phase out of packages satisfying the 1967 IAEA requirements, including DOT specification packages; • Require that manufacture of all Type B specification packages conforming to Safety Series No. 6 (1967) be prohibited as of the effective date of this rule and that use of these packages be prohibited two years after the effective date of this rule; and • Add a requirement that the active material in an instrument or article intended to be transported in an excepted package be completely enclosed by the non-active components. B. Issue Discussion Issue 1: Nuclide-Specific Exemption Values Background. The HMR currently use a specific activity threshold of 70 Bq/g (0.002 μCi/g) for defining a material as radioactive for purposes of transportation (see definition of radioactive material in § 173.403), and radioactive material is not subject to the requirements of the HMR if its specific activity is equal to or below this value. The total activity per gram of all radionuclides present in a material is considered; i.e. , if a chain of radionuclides is present, the material is regulated if the sum of the activities/gram of all radionuclides in the chain is 70 Bq/g or more. We use a threshold specific activity to determine the applicability of regulatory requirements because all material contains some level of radioactivity, although often in trivial amounts. In order not to regulate as radioactive material everything that is transported, it is necessary to specify what materials should be regulated in transport. The threshold value of 70 Bq/g has been thought by the international regulatory authorities to be sufficiently low as to present a negligible risk to transport workers or to members of the public from the radioactive nature of the material. In issuing TS-R-1, IAEA decided to replace the 70 Bq/g specific activity or activity concentration threshold with values that may be different for each radionuclide. In addition, TS-R-1 establishes threshold values for the total activity in a consignment, below which the risk is so small that the material could be transported without being subject to transportation regulatory requirements. These threshold values for specific activity and activity in a consignment are termed “exemption values” in TS-R-1. According to paragraph 236 of TS-R-1, “radioactive material,” i.e. , radioactive material that is considered radioactive for purposes of transport, is defined as the subset of radioactive material for which both the specific activity and the consignment activity are greater than the exemption values. The principles upon which the determination of the exemption values is based are that: (a) The radiation risks to individuals caused by the exempted practice or source are sufficiently low as to be of no regulatory concern; (b) The collective radiological impact of the exempted practice or source is sufficiently low as to not warrant regulatory control under the prevailing circumstances; and (c) The exempted practices and sources are inherently safe, with no appreciable likelihood of scenarios that could lead to a failure to meet the criteria in (a) and (b). The members of IAEA in deliberations leading to the adoption of Safety Series No. 115, “International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources,” IAEA, Vienna (1996) (also known as BSS), agreed to adopt exemption values for activity concentrations and total activities related to practices involving radioactive materials and to sources of radioactive material in fixed facilities. In accordance with “Radiation Protection-65: Principles and Methods for Establishing Concentrations and Quantities (Exemption Values) Below Which Reporting is not Required in the European Directive,” by M. Harvey et al., Commission of the European Communities Doc. XI-028/93, 1993, each exemption value was selected to be the lesser of: (a) That at which a member of the critical group, under defined models (representative scenarios, including guiding assumptions) for practices and sources, would receive an effective dose of 10 μSv (1 mrem) in a year under normal conditions; or (b) That for which the collective dose to all persons exposed to those practices and sources in a year for normal conditions is 1 person-Sv (100 person-rem). The BSS calculations used three scenarios: (1) Normal use in the workplace, (2) an accident in the workplace where the probability of an exposure due to the accident was taken into account, and (3) exposure to the public as the result of disposal in a public landfill. Criteria (a) and (b) were applied to all scenarios considered. Criterion (a) was used with all scenarios to determine initial BSS exemption values. The collective dose criterion (b) was also applied, but found not to affect the results. The BSS calculation also incorporated two other criteria. One was an annual limit of 50 mSv (5 rem) to the skin of an individual. The other was that the exemption level would be chosen to assure that in the case of an accident, even in pessimistic situations, a dose limit of 1 mSv (100 mrem) would not be exceeded. In principle, the BSS exemption values assure that, for exempt practices and sources within practices at fixed facilities, no member of the public would likely receive an annual dose greater than 10 μSv (1 mrem). In practice, however, since about 300 radionuclides are involved, the values obtained were simplified by rounding to powers of 10, such that calculated xxx values between 3×10 x and 3×10 x+1 would be replaced in the BSS tables by 1×10 x+1 . By determining the exemption values for each radionuclide so that they correspond to a single annual dose of 10 μSv (1 mrem), the calculations assure, within the uncertainty of the models employed, that the use of each radionuclide at its specific activity or total activity exemption value level will involve roughly the same small risk, since radioactivity is regulated under the assumption that the risk is proportional to the dose received. The rounding process used reduces that uniformity in risk, although it should be emphasized that the risks among which those variations occur are still small. Because the BSS exposure scenarios and pathways do not explicitly address the transport of radioactive material, during the development of TS-R-1 additional calculations were performed for 20 commonly transported radionuclides. The calculations considered transport scenarios consisting of a subset of the BSS scenarios thought to be pertinent to transportation and additional transport-specific scenarios [A. Carey et al., “The Application of Exemption Values to the Transport of Radioactive Materials,” Final Report, CEC Contract CT/PST6/1540/1123 (September 1995). The calculations were originally performed for presentation at the Fourth Technical Committee Meeting on the Revision of the IAEA Regulations for the Safe Transport of Radioactive Material, Vienna, 25-29 September, 1995, at the request of SAGSTRAM-XI (11th Meeting of the IAEA Standing Advisory Group on the Safe Transport of Radioactive Material, TC-407.9, 6-10 March, 1995). Synopses of this report may be found in: “The Application of Exemption Values to the Transport of Radioactive Materials,” by P. Francois et al. , Proceedings of the 11th International Conference on the Packaging and Transportation of Radioactive Materials (PATRAM '95), Las Vegas, NV, Vol. I, p. 462 (1995); and “The Application of Exemption Values to the Transport of Radioactive Materials,” by P. Francois et al. , Proceedings of the IRPA 9 Conference, Vienna, Vol. 4, p. 674 (1996).]. For purposes of the calculations, it was first shown that at the current threshold activity concentration of 70 Bq/g, under the transport-derived scenarios, 14 of the 20 radionuclides considered were predicted to result in an annual individual dose greater than 1 mrem with 4 resulting in doses greater than 1 mSv (100 mrem); the highest was Th-232N (Th-232 in secular equilibrium with its decay products), with a predicted dose of about 2.3 mSv (230 mrem). Of the six radionuclides with annual doses less than 1 mrem, S-35 had the lowest dose, about 0.02 μSv (0.002 mrem). The average annual dose for these 20 nuclides was about 0.50 mSv (50 mrem). When the calculations were reversed, to find what activity concentration for each nuclide would result in an annual dose of 10 μSv, the necessary threshold activity concentrations ranged from 0.3 Bq/g for Th-232N to 36,000 Bq/g for S-35. The same conditions used for fixed facilities were applied to the transport exemption value calculations for the 20 nuclides, namely that a member of the public (including transport workers, since the objective is to estimate the dose they might receive if they were not subject to the transportation regulations) receive no more than about 10 μSv (1 mrem) per year, and that the annual collective dose be no greater than 1 person-Sv (100 person-rem). The main purpose of this analysis was to check the adequacy, with regard to the dose criteria, of the BSS exemption values in the case of exposure situations associated with transport. SAGSTRAM-XI accepted that if the exemption values provided by the analysis of transport scenarios differed by no more than one to two orders of magnitude, then it would be preferable to directly apply the BSS exemption values to the transport regulations, instead of defining a separate set of exemption values for transportation, in order to provide consistency with other practices. The results of the analysis of transport scenarios did in fact result in exemption values that did not differ from the BSS values by more than two orders of magnitude, with the exception of one radionuclide, Kr-85, for which it was argued that because Kr-85 is not transported in such large containers the scenarios used were overly conservative. On this basis it was decided to utilize the BSS exemption values for the transport regulations. For those radionuclides in the transport regulations not listed in the BSS, transportation exemption values were calculated using the BSS methodology. Because of the rounding procedure used to obtain the BSS values and the differences between the BSS- and transport-derived exemption values even without rounding, the annual individual doses derived using the transport scenarios combined with the BSS exemption activity concentrations for the 20 nuclides considered are no longer equal to 10 μSv (1 mrem). A rough calculation, assuming strict proportionality between the annual dose and the transport-derived activity concentration exemption values, indicates that those calculated doses, using the BSS values in TS-R-1 for the 20 nuclides, now range (except for Kr-85, which gave an anomalously high value) from about 3 μSv (0.3 mrem) for C-14 to about 420 μSv (42 mrem) for Au-198. If Kr-85 is included, the estimated annual dose to a transport worker transporting one of these 20 radionuclides at the TS-R-1 exemption activity concentrations, averaged over these 20 radionuclides, is about 230 μSv (23 mrem). There are some nuclides listed in Table I of TS-R-1 that contain a reference to footnote (b). These nuclides have the radiological contributions from their listed decay products, assumed to be in secular equilibrium with the initial radionuclide in the decay chain (activities of all members in the chain assumed equal, taking into account branching ratios), already included in the footnoted exemption value. For example, Sr-90 has a TS-R-1 exemption activity concentration of 100 Bq/g. This means that one may transport up to 100 Bq/g of Sr-90, which is equivalent to up to 200 Bq/g of Sr-90 combined with its decay product Y-90, before becoming subject to the regulations for transporting radioactive material. Discussion. Commenters to the 1999 ANPRM who address this issue generally do not support a change in the HMR definition of “radioactive material.” One commenter who supports the change states that requiring materials to meet both the concentration criteria and the consignment activity level to be classed as Class 7 (radioactive) material adds much needed flexibility to the rules and suggests that this revision would be of great value, particularly for research institutions that frequently need to transfer small quantities and low concentrations of radioactive materials. Among commenters who oppose the IAEA revisions, several state that the use of radionuclide-specific concentration and total consignment exemption thresholds to determine whether a material is to be considered “radioactive” for purposes of transport would require substantial additional effort with few, if any, benefits. Other comments note that the current definition of radioactive material has served the United States well for several decades and assert that the benefits to be derived from a risk-based system that spans 7 orders of magnitude are not significant when compared to the simplicity of the current system. Another commenter states that the new IAEA thresholds will create problems with the transportation of consumer products since the new thresholds would result in varying points at which the regulations would apply, depending on the material. Many commenters who addressed this issue as part of the HM-215D rulemaking [Docket No. RSPA-2000-7702] state that the TS-R-1 revised definition of radioactive material lowers the level of safety provided by the current regulations, because under TS-R-1 some of the exemption activity concentrations are higher than the current 70 Bq/g. Several commenters suggest combinations of the current and proposed radioactive material definitions, such as using the TS-R-1 approach for international shipments while retaining the 70 Bq/g threshold for domestic shipments or adopting the new specific activity exemption values only in those cases where the new values are greater than 70 Bq/g and retaining the 70 Bq/g threshold for the remainder. RSPA believes that the improved risk basis for the proposed exemption values and the advantages of harmonization with the international radioactive material transport regulations outweigh the benefits of the current more simple system. The proposed activity concentration exemption values distribute the risk to workers and members of the public more equitably, around a value corresponding to an annual dose of approximately 230 μSv (23 mrem). This should be compared with the situation using the single activity concentration threshold of 70 Bq/g, which for the same 20 radionuclides distributes the risk around a value corresponding to an annual dose of about 500 μSv (50 mrem). We agree that the new system is more complex. However, for most manufactured products the determination of whether those products fall under the domain of the HMR need be made only once or very occasionally. For those cases where there is more variation in the specific activity of the consumer product, such as might be the case for products manufactured from ores containing small amounts of naturally occurring radioactive material, the types of radioactive material which may be present are relatively well known, and it will usually be possible to set up a standard procedure for determining whether the product is subject to the HMR. It should be kept in mind that with the current 70 Bq/g threshold such determinations are also necessary. Because some proposed exemption concentrations are greater than the current value of 70 Bq/g, it might be argued that in these cases we are proposing to “lower the level of safety.” However, the increase in risk in these cases is in a range where the risk is very small. For P-32, for example, the increase in exemption level from 70 Bq/g to the BSS threshold of 1,000 Bq/g results in an increase of the risk for a worker transporting this material without being subject to the HMR from a value corresponding to 0.58 mrem/y up to a value corresponding to 8.3 mrem/y. For comparison purposes, it was mentioned earlier in this section that for the 20 nuclides to which the transport and fixed facility scenarios were first applied, the original threshold of 70 Bq/g corresponds to an average annual dose of about 50 mrem, while use of the BSS exemption activity concentrations adopted in TS-R-1 corresponds to an average annual dose of about 23 mrem. Thus, use of the proposed exemption values will reduce the overall risk by about 50%. We prefer not to adopt a combination approach to defining radioactive materials in which different exemption values would apply to international and domestic shipments, since doing so would tend to make the proposed system still more complex, and lead us away from the goal of harmonization. Accordingly, we propose to adopt the nuclide-specific exemption activity concentrations and the nuclide-specific exemption consignment activities listed in TS-R-1. These would be listed in a new section (§ 173.436). The purpose of adopting the TS-R-1 exemption values would be to assure continued consistency between domestic and international regulations for the basic definition of radioactive material. In addition, adoption of the TS-R-1 exemption values would reduce and make more uniform the risk to transport workers and members of the public when radioactive material is transported at levels below the exemption values, where these materials would not be regulated as radioactive. Adoption of these values would provide a consistent level of protection for all radionuclides and would result in a single regulatory structure valid for both domestic and international shipments, thus reducing the potential for error in classifying the material for shipment, reducing costs for those entities that ship domestically and internationally, and increasing regulatory efficiency. Since shippers who have materials with radioactivity near the exemption levels currently need to know what radionuclides and activity levels are present in order to determine compliance with the 70 Bq/g threshold, the primary changes that would be needed when using the nuclide-specific exemption values would be those introduced to apply the sum rules for mixtures, and possible changes in computer software, recordkeeping, training, and other mostly administrative requirements. We believe that the cost savings associated with the enhanced regulatory efficiency due to having common domestic and international criteria for classifying material for shipment, and with thus facilitating the goal of consistency between countries with respect to future modifications of the regulations, outweigh the additional costs resulting from applying the new procedures. As described under Issue 2, certain naturally occurring radioactive materials with activity concentrations or activities up to 10 times the exemption values, which are not extracted for their radioactive properties, would be excluded from these regulations in order to avoid regulating large amounts of these materials which have not heretofore been subject to radioactive material transport regulations. Since, however, for some radionuclides 10 times the exemption activity concentrations will not be the same as the present 70 Bq/g threshold, some currently unregulated naturally occurring radioactive materials will fall under the scope of the regulations, and some materials which were formerly regulated because they had a specific activity slightly greater than 70 Bq/g, may no longer be regulated. The former situation would lead to some additional costs for the companies involved; however, that would be at least partially offset by reduced costs for shipping those materials in the latter category. Commenters did not provide details or numbers to aid in estimating the magnitude of the projected costs or cost savings, or who would be affected. Issue 2: Naturally Occurring Radioactive Materials An important addition to the list of circumstances in TS-R-1 under which the regulations do not apply is found in paragraph 107(e) of that document. That paragraph excludes certain naturally occurring radioactive materials from being regulated during transportation. The purpose of the exclusion is to take into account practical difficulties that result from reducing the exemption concentrations for several alpha emitters from the present level of 70 Bq/g (0.002 μCi/g) in conjunction with the adoption of nuclide-specific exemption values (see the discussion under Issue 1). Certain of these radionuclides, such as natural uranium and natural thorium, are widespread in nature and found in almost all ores, such as coal, phosphate, gypsum, or a large variety of metals or other minerals. Application of the new exemption values to the radioactive material in these ores would result in bringing under the scope of the regulations enormous amounts of material that have until now not been subject to those regulations, and whose specific activity level presents a very low hazard. On the other hand, there are ores in nature where the specific activity concentration is much higher than the exemption values, and the regular transport of these ores may require the use of the radiation protection measures inherent in applying the regulations. Thus, for low specific activity ores not intended to be processed for use of those radionuclides, a threshold of 10 times the exemption values provides an appropriate balance between the need for radiological controls at higher concentrations and the practical problems associated with over-regulation which would arise for large quantities of material with low specific activity concentrations of naturally occurring radionuclides. Discussion. Commenters to the ANPRM generally agree that the HMR should be revised to incorporate the scope limitations of TS-R-1. Commenters state that this would remove HMR controls from consumer commodities, such as smoke detectors, and radioactive material that is an integral part of the packaging, such as casks with depleted uranium shielding. (We note that this is not necessarily a valid argument for incorporating the cited scope limitation since, for example, materials used in smoke detectors are not usually naturally occurring, and uranium in depleted uranium shielding would have been originally mined for its radioactive properties. In addition, such materials are usually found to be in quantities above ten times the proposed exemption values.) Commenters further state that, since these items are inherently safe, they should be removed from the scope of the HMR. Several commenters state that any change to the scope should ensure that materials regulated as “radioactive” for transportation purposes does not extend to ores and natural materials, including products made from those ores and materials, that are outside the nuclear fuel cycle and do not exceed an appropriate regulatory threshold and, thus, present a very low hazard. Several commenters suggest that a provision to allow radiation protection personnel to carry excepted quantities of solid radioactive material on passenger aircraft as checked baggage should be added to allow radiation protection personnel to travel to a site with appropriate radiation detection equipment without the worry that they are in violation of the HMR. These commenters assert that this provision would have a very direct benefit to public health protection and since the quantities involved are far below the A 1 or A 2 limits, the risk would not be significant. We note that the HMR currently permit carriage aboard an aircraft of a limited quantity of radioactive material, or an instrument or article containing radioactive material, meeting the requirements of § 173.421 or § 173.424, in checked baggage. This was formally stated in a letter issued on March 19, 1991, from the Federal Aviation Administration Director of the Office of Civil Aviation Security Operations to the Director of State Programs of the U.S. Nuclear Regulatory Commission. Therefore, we do not agree that a specific regulatory provision is necessary. One commenter asserts that there is no significant safety or economic impact from the application of the graded approach to performance standards described in paragraph 106 of TS-R-1. The commenter expresses support for the incorporation of the three severity levels (routine, normal and accident conditions of transport) to determine the level of regulation required by the HMR. The HMR are designed as to assure that the severity of regulatory requirements is proportional to the hazard of the materials to be transported. TS-R-1 and several previous revisions of the IAEA regulations refer to the industrial and Type A package performance requirements, found in 49 CFR 173.465, as “tests for demonstrating ability to withstand normal conditions of transport,” and the additional performance requirements for Type B and fissile material packages, found in 10 CFR 71, as “tests for demonstrating ability to withstand accident conditions of transport.” We believe that the distinction made in TS-R-1 between routine (incident free) and normal (minor mishaps) is artificial, and does not enhance the use of the graded approach. Finally, one commenter suggests that language in the regulations should be simplified and clarified, rather than further complicated, to ensure understanding by various segments of the distribution network with a wide range of educational levels. This commenter states that TS-R-1 uses several terms, the definition and application of which are unclear and vulnerable to subjective interpretation. Examples include “worker,” “appropriate training,” “unlikely to exceed,” “appropriate records,” and “regularly occupied working areas.” This commenter suggests that, due to the extensive interface between transport of radioactive materials and sites subject to NRC, Agreement State, and other nuclear regulatory agency jurisdiction, the definition and application of terms should be clarified and consistent between TS-R-1 and the regulations of these other agencies, and should be consistent with international regulations. We agree. In this NPRM we have attempted to reduce the number of undefined terms, and to add or modify definitions where appropriate. Accordingly, in this NPRM we are proposing to provide an exception in the HMR, in § 173.401, that naturally occurring radioactive materials not intended to be processed for their radioactive components and with activity concentration not to exceed ten times the exemption activity concentrations would not be subject to the requirements of the HMR. Issue 3: Changes in A 1 and A 2 Values Background. The international and domestic transportation regulations use calculated activity values for each radionuclide to specify the amount of radioactive material that is permitted to be transported in particular packaging and for other purposes. These numbers, known as the A 1 and A 2 values, indicate the maximum activity that is permitted to be transported in a Type A package. For example, A 1 is the maximum activity of radioactive material in special form, and A 2 is the maximum activity in non-special form that may be transported in a Type A package. A 1 and A 2 values for the most commonly transported radionuclides are listed in 49 CFR 173.435, and in Appendix A to 10 CFR 71. A 1 and A 2 values for most of the commonly transported radionuclides were provided in the 1973 IAEA Safety Series No. 6, and were based on certain dosimetric models and the assumption of certain exposure scenarios and pathways. These models and scenarios were extended and improved in the 1985 Safety Series No. 6, where the calculation procedure was called the “Q-system.” This resulted in changes in the A 1 and A 2 values listed there. More recent biokinetic data and dosimetric models have been used to update the Q-system and the resulting A 1 and A 2 values in the 1996 TS-R-1. To determine whether a given amount of radioactive material may be shipped in a Type A package, or if a Type B package must be used instead, the total activity to be shipped is compared directly with the appropriate A 1 or A 2 value. Fractions or multiples of the A 1 and A 2 values are also used for several other purposes, such as specifying Type B package activity leakage limits, low specific activity and excepted package limits, and determining whether a given amount of radioactive material constitutes a Highway Route Controlled Quantity. Based on the results from the updated Q-system (see TS-G-1.1, Appendix I), IAEA has adopted new A 1 and A 2 values for radionuclides listed in TS-R-1 (see paragraph 201 and Table 1 of TS-R-1). IAEA adopted these new values based on calculations that were performed using the latest dosimetric models recommended by the International Commission on Radiological Protection (ICRP) in Publication 60, “1990 Recommendations of the ICRP.” A thorough review of the Q-system also included incorporation of data from updated metabolic uptake studies. In addition, several refinements were introduced in the calculation of contributions to the effective dose from each of the pathways considered. The pathways themselves are the same ones considered in the 1985 version of the Q-system, i.e., external photon dose; external beta dose; inhalation dose; skin and ingestion dose from contamination; and dose from submersion in gaseous radionuclides. The impact of these analyses is that for each radionuclide a thorough up-to-date radiological assessment has been performed of potential exposures to an individual should a Type A transport package of radioactive material be involved in an accident during transport. The new A 1 and A 2 values reflect that assessment. While the dosimetric models and dose pathways within the Q-system were thoroughly reviewed and updated, the reference doses that the model uses were unchanged. The reference doses are the dose values that are used to define a “not unacceptable” dose in the event of an accident. Consequently, while some revised A 1 and A 2 values are higher and some are lower, the potential dose following an accident is the same. The revised dosimetric models are accepted internationally as more accurate ways of calculating the doses from individual nuclides, and this improvement in accuracy and the additional refinements in the pathways calculations result in various changes to the A 1 and A 2 values. In other words, where an A 1 or A 2 value has increased, the potential dose is still the same—the use of the revised dosimetric models merely illustrates that a higher activity of that radionuclide is actually required to produce the same reference dose. Conversely, where an A 1 or A 2 value has decreased, the revised models show that less activity of that nuclide is needed to produce the reference dose. Many A 1 and A 2 values have been adjusted to reflect more recent dosimetric data; in general, the adjustments are not large. Some radionuclides for which A 1 and A 2 values are presently listed in 49 CFR 173.435 and Appendix A of 10 CFR 71 do not appear in Table I of TS-R-1. These are Ar-42, Au-196, Es-253, Es-254, Es-254m, Es-255, Fm-255, Fm-257, Ho-163, Ir-193m, Nb-92m, Po-208, Po-209, Re-183, Te-118, and Tm-168. All except the Einsteinium (Es) and Fermium (Fm) isotopes appear in Safety Series No. 6, 1985 Edition; the latter (Es and Fm) isotopes were appended to the tables in DOT's and NRC's domestic regulations when these incorporated the 1985 IAEA regulations. Through an oversight, numerical A 1 and A 2 values were never entered for Es-255. The above nuclides were not included in TS-R-1 Table I because of uncertainties in their decay schemes and/or the biological models used to determine doses from internal exposures (Dr. K. Eckerman, Oak Ridge National Laboratory). Discussion . Several commenters to the ANPRM support the new A 1 and A 2 values in general, but request retention of the present A 2 value of 20 Ci for domestic shipments of Mo-99, citing an increase in the needed number of shipments with consequent greater radiation exposure to workers and greater costs as probable consequences of eliminating the present 20 Ci domestic exception. We note that the A 2 value for Mo-99 in TS-R-1 is 0.6 TBq (16.2 Ci), compared to 0.5 TBq (13.5 Ci) in Safety Series No. 6, 1985 Edition. Upon further review of these comments, and of similar comments received and analyzed during the incorporation of Safety Series No. 6, 1985 Edition changes into the HMR (60 FR 50292), we are proposing to continue to allow this domestic exception of 0.74 TBq (20 Ci) for the A 2 value of Mo-99. A major manufacturer and a major user of californium-252 (Cf-252) neutron sources oppose any proposal that would reduce the A 1 quantity for Cf-252 from its present value of 0.1 TBq (2.7 Ci) to 0.05 TBq (1.35 Ci). One commenter states that reducing the A 1 limit for Cf-252 is not justifiable based on potential radiation exposure rates, and emphasizes that the physical and chemical forms of the californium sources are such that this material, if released, is insoluble in water and will not burn in air, and that this was not taken into account in the Q-system calculations. This commenter asserts that Cf-252 is shipped in Type A packages, and that the costs of designing, qualifying and using Type B packages for sources that will continue to have an activity no greater than 0.1 TBq (2.7 Ci) are much higher and not necessary. This commenter additionally states that using a special form Type A limit which is one half the previous value would double the number of shipments, thereby increasing the risk of transport damage and increasing the potential of exposure of transport workers to radiation. The commenter further states that the company has a substantial investment in the design and construction of Type A packages for transporting Cf-252 in the 0.05 to 0.1 TBq range, and that a general purpose unit for shipping 5 mg (0.1 TBq) of Cf-252 weighs several tons. Changing to the TS-R-1 A 1 value would render these packages unusable. The company estimates that its costs for dismantling and disposing of these packages, which may contain activated metallic parts and would have to be treated as potentially radioactive material, to be on the order of $500,000, not counting the high additional costs required to design, construct, test, and obtain certification for new Type B containers. During analysis of these comments, RSPA and NRC staff members learned that the IAEA is proposing, for the 2003 revision of TS-R-1, to change the A 1 and A 2 values in TS-R-1 for Cf-252 back to the values currently in the HMR. For this reason we decided to include in this rulemaking a domestic exception to the TS-R-1 Cf-252 A 1 and A 2 values, retaining the present Title 49 A 1 and A 2 values for domestic shipments. Import and export shipments, however, would be subject to the TS-R-1 A 1 and A 2 values. Other commenters are supportive of the proposed adoption of the new A 2 activity limits. One commenter, who will be moving large quantities of radioactive waste (especially LSA and SCO) as result of environmental cleanup, sites (or facilities) closures, and waste repository operations, states that adopting the new A 2 values will increase the waste shipping volume per conveyance. As a result, the transportation costs will decrease and the number of packagings required will be reduced. In this NPRM, we propose to incorporate the TS-R-1 A 1 and A 2 values into the HMR, in § 173.435, with the exceptions noted above for Mo-99 and Cf-252. There are two principal arguments for adopting the new values: One is the need to continue to assure the safety of workers and the public, taking into account the latest scientific analyses. The other is the need for harmonization with the international regulations in this area. This harmonization would eliminate the complexities resulting from having to move back and forth between two already complex A 1 and A 2 systems, and the resultant increased probability of inadvertent errors from doing so. In addition, retaining the current values, which are essentially those from Safety Series No. 6, 1985 Edition, would in most cases not be scientifically justifiable, since the new values were introduced in TS-R-1 precisely in order to take into account advancements in scientific knowledge. In this NPRM, we propose to not include A 1 and A 2 values for the 16 isotopes described above which are listed in our present domestic regulations, but which do not appear in TS-R-1. This means that the default A 1 and A 2 values in TS-R-1 would have to be used for these isotopes. However, DOT regulations at § 173.433(b) provide a mechanism for obtaining approval from the Associate Administrator for Hazardous Materials Safety to use convincingly documented values of A 1 and A 2 for radionuclides not listed in the table in § 173.435. We propose in this NPRM to include a similar mechanism to obtain approval for use of non-default exemption values for these radionuclides. Issue 4: Communication Changes Background. The TS-R-1 revisions in hazard communication includes the following: • Proper shipping names and UN identification numbers are changed (Table VIII in TS-R-1); • UN identification numbers now must be marked on excepted packages (paragraph 535), and package type, international vehicle registration code (the letters USA in the case of the U.S.) and packaging manufacturer now must be marked on all industrial and Type A packages (paragraph 537); • Radionuclide activities must be expressed in SI units (paragraphs 543 and 549); • The former criticality transport index (criticality TI) for fissile material has been abolished, and replaced with the CSI (paragraph 218); TI is now derived exclusively from the maximum radiation dose rate at one meter from the package (paragraphs 243, 526, 527); and • For fissile material, a fissile label is introduced, upon which the CSI must be displayed (Figure 5, paragraphs 544, 545). Industrial packagings are to carry the markings TYPE IP-1, TYPE IP-2 or TYPE IP-3 as appropriate (paragraph 537). Discussion. Several commenters note that changing proper shipping names will require all shipments to be re-labeled. One commenter states that the majority of labels that would be affected are metal and pop-riveted directly onto the container, requiring major work to replace these labels with no net safety benefit. These commenters further assert that many preprinted shipping papers will be affected and request a grandfathering or transition period to update the paperwork to reflect the new names. We agree that there would be definite and sometimes appreciable costs associated with the change to the use of new proper shipping names and UN identification numbers. However, those who import or export radioactive material, as well as those who offer for transportation such material domestically to air carriers operating under the Technical Instructions for the Safe Transport of Dangerous Goods by Air of the International Civil Aviation Organization (ICAO), must necessarily use the new shipping names and UN numbers as of ICAO's implementation of the TS-R-1 requirements effective July 1, 2001. In addition, in order to accommodate domestic and international air transport of radioactive material in accordance with the ICAO Technical Instructions as well as domestic transport by other modes in accordance with the present requirements of Title 49, and to permit the use in transport by those other modes of packages which had been marked with the new names and numbers for air transport, the final rule adopted under docket HM-215D authorizes the use for all modes of either the previous proper shipping names and UN numbers or the new ones. Thus, many shippers are already required to use the new names and numbers or are doing so voluntarily. Morever, since these transition arrangements are likely to remain in place until the effective date of the final rule that is expected to result from this NPRM, there should be ample time to implement the proposed changes. Several commenters supported the adoption of the new package labeling requirements to provide information on the CSI. Commenters state that the CSI provides essential information relevant for proper separation of packages with fissile material contents during their storage and stowage. Commenters further state that there would be a one-time operational impact and cost of incorporating the new FISSILE label. One commenter estimates this one-time cost to their operation to be a few million dollars that would include personnel training; procedure revisions; and package, overpack and container labeling. Commenters request a five-year transition period to allow for the use and depletion of existing label inventories and to develop, manufacture and obtain new labels prior to the implementation date. We agree that there will be an appreciable but not major one-time impact and a minor ongoing impact of using the new FISSILE labels for shippers of fissile material, but that the simplicity and improvement in safety that will result from distinguishing the CSI from the TI fully justifies this proposal. The use of existing label inventories should not be a problem, since we are proposing no change to existing labeling requirements. There should be sufficient time between the publication date and the effective date of a final rule to obtain the new FISSILE labels, particularly since these labels are already required for most international fissile material shipments. Several commenters oppose the new excepted package marking requirements in TS-R-1. They assert that current HMR do not require exterior marking of excepted packages, and suggest that the addition of the UN identification number with the letters “UN” would do little to enhance the understanding of the contents of excepted packages or the safety of individuals responding to excepted package incidents. They further state that the addition would more likely confuse carriers and end users. We are aware of the sometimes appreciable initial costs, and the change of culture that placing the UN identification numbers on excepted packages would entail. However, we do not agree that this addition will confuse carriers and end users, nor that it would do little to enhance the understanding of package contents. Possible confusion should be minimal, since carrier personnel are required to receive appropriate training in accordance with subpart H of Part 172. The addition of the UN identification numbers would indicate to first responders in an accident that packages containing small quantities of radioactive material are present. By referring to the DOT Emergency Response Guidebook, in the use of which all first responders are required to be trained, appropriate remedial measures can be taken. Also, as in the case of other TS-R-1 requirements, those who import or export commercial items in excepted packages, as well as those who offer for transportation such items domestically using air carriers who operate under the ICAO Technical Instructions, are currently required to mark the UN identification numbers on those packages, so that the harmonization of our requirements with those of TS-R-1 in this respect seems indicated. On balance, the benefits of adopting this requirement outweigh the disadvantages. Commenters to the ANPRM generally oppose adoption of any new requirements that would require the placarding of all vehicles engaged in the transportation of radioactive materials labeled RADIOACTIVE WHITE-I, RADIOACTIVE YELLOW-II, or RADIOACTIVE YELLOW-III. Currently, the HMR require the placarding of vehicles transporting YELLOW-III labeled packages of radioactive materials, or certain exclusive use shipments of LSA materials or SCO. Commenters representing radiopharmaceutical shippers and carriers state that requiring all radioactive material shipments to be placarded would result in adverse operational and financial impacts on nuclear pharmacies and radiopharmaceutical distribution in the United States by requiring these facilities to employ only driver personnel with commercial driver's licenses, who generally command higher salaries. These commenters assert that the established safety record for transporting RADIOACTIVE WHITE-I and RADIOACTIVE YELLOW-II labeled packages in the United States does not justify a tightening of the regulations for local transportation of these packages to hospitals and clinics. These commenters suggest that the increased cost of running a program encompassing some 500 nuclear pharmacies throughout the United States would be immense without any improvement in safety. We agree with these comments, which can be extended to the transport of other relatively low levels of radioactive material; therefore, we propose no change to the current policy of requiring RADIOACTIVE placards only on vehicles carrying packages with RADIOACTIVE YELLOW-III labels, or on certain exclusive use vehicles transporting LSA or SCO, as described in proposed § 173.427. Accordingly, in this NPRM we are proposing to adopt, in § 172.101, the new proper shipping names and UN identification numbers, except for those referring to Type C packages, or to fissile LSA or SCO materials. They are not needed, since we do not propose to adopt the concept of Type C packages for domestic use (see Issue 7), and fissile material (above the level considered fissile-excepted) may not be transported domestically as LSA material or SCO. We do not propose to make any substantial change with respect to the use of SI units to describe activity or radiation levels. Part 172 currently requires the use of SI units or SI units followed by the appropriate quantity in “customary” units; it is our position that this does not violate the TS-R-1 requirement, facilitates communication and reduces the possibility of errors for domestic shipments, while promoting familiarity with the use of the SI system. We do propose to require in §§ 172.203(d) and 172.403(g), if customary units are to be used, that the appropriate quantity and customary units be placed within parentheses positioned after the original quantity expressed in SI units. We also propose to adopt the use of the CSI to refer to what was formerly the criticality control transport index, and to restrict the use of the concept of TI to a number derived purely from the maximum radiation level at one meter from the package. In conjunction with this, we propose that the new fissile label be placed on each fissile material package, and that the CSI for that package be noted on the FISSILE label. This would make it obvious that the package is carrying fissile material, and would reduce the complexity of the system presently in use, in which for packages of fissile materials the transport index is determined through a comparison between a number related to radiation levels and another determined on the basis of a criticality analysis. It would also simplify decisions as to how many packages can be grouped together, since under the proposed system the description of radiation and criticality hazards would be uncoupled, and during transport each hazard can be considered separately. We propose to adopt the requirement that excepted packages be marked with the UN identification number, that industrial packagings be marked with the package type, and that industrial and Type A packages be marked with the international vehicle registration code of the country of origin of packaging design. We propose to remove some former requirements which would become redundant upon adoption of the new proper shipping names, such as the requirement that the shipping description contain the words “Radioactive Material” unless those words are included in the proper shipping name. Because the isotope plutonium-238 has been removed from the TS-R-1 definition of fissile material (see the discussion for Issue 9), we propose to remove it from our definition of fissile material in § 173.403, and to remove the reference to it in the list of fissile radionuclides for which the weight in grams or kilograms may be listed instead of or in addition to the activity, in the shipping paper or radioactive label description of the radioactive contents of a package. We propose to improve readability and clarity of the HMR by moving the labeling requirements for overpacks to subpart E of part 172, and by stating explicitly that the Class 7 label category for an overpack is to be determined using the maximum surface radiation level on the interior package(s) unless the overpack is the appropriate package type for its contents. Issue 5: Low Specific Activity (LSA) Materials and Surface Contaminated Objects (SCO) Background. On September 28, 1995, in a final rule, published under Docket, HM-169A (60 FR 50292), we attempted to refine the existing LSA and SCO regulations by adopting complementary, but not additional, features of the LSA and SCO provisions of the IAEA regulations. This approach was considered best because it offered minimal changes to existing requirements while facilitating international transport consistent with IAEA regulations. Shortly after implementing this new regulatory program, we recognized the shortcomings of not adopting all the provisions, such as the Safety Series No. 6 definition of contamination. IAEA TS-R-1 proposed a new class of LSA-I material (paragraph 226), consisting of radioactive material in which the activity is distributed throughout and the estimated average specific activity does not exceed 30 times the activity concentration exemption values. The purpose of this category is to allow shipment as LSA-I of very low specific activity materials containing one or more of a variety of radionuclides. Discussion. In response to the ANPRM, commenters agreed that we should adopt a definition of contamination that is consistent with the one used in TS-R-1. Due to the insufficient availability of industrial packages, significant volumes of material that would have to be repackaged and the lack of a significant safety benefit, many commenters support continued use of strong, tight packages for transport of LSA and SCO material. Commenters also suggest that due to minimal risk but large size or volume of many shipments of LSA and SCO, provisions for unpackaged material are appropriate and necessary. One commenter requests that we retain the present LSA-I classification in § 173.403 which refers to mill tailings, contaminated earth, concrete, rubble, other debris, and activated material in which Class 7 (radioactive) material is essentially uniformly distributed and the average specific activity does not exceed 10 − 6 A 2 /g. We do not agree. We propose to replace this classification with the new TS-R-1 classification of other radioactive material in which the activity is distributed throughout and the estimated average specific activity does not exceed 30 times the activity concentration values. The present LSA-I classification does not provide an equivalent level of safety to the exemption-based classification from TS-R-1 which we are proposing to adopt. In this NPRM, we are proposing to simplify the HMR by bringing them into closer harmony with the TS-R-1 by adopting a definition of contamination, an authorization to transport unpackaged LSA and SCO, and an authorization to use qualified tank containers, freight containers and metal intermediate bulk containers as industrial packagings, types 2 and 3 (IP-2 and IP-3). We also propose to adopt a new class of LSA-I material (paragraph 226), consisting of radioactive material in which the activity is distributed throughout and the estimated average specific activity does not exceed 30 times the activity concentration exemption value. We believe that incorporating these changes will greatly simplify LSA and SCO regulations by bringing them into closer harmony with the TS-R-1. Specifically, we believe that the addition of a contamination definition and the authority to transport unpackaged LSA and SCO will better focus the regulations on radioactive material that truly poses a hazard to persons, property and the environment. We also believe the authorization to use qualified tank containers, freight containers and metal intermediate bulk containers as industrial packagings and the other packaging changes made for LSA and SCO would greatly simplify the HMR with no increase in risk. We also propose to eliminate present paragraph § 173.427(d), which when offered for transportation for disposal or recovery by means other than aircraft, excepts from all requirements of the HMR for Class 7 materials LSA material and SCO that conform to the provisions of 10 CFR 20.2005. Such material is 1.85 kBq (0.05 μCi) or less of H-3 or C-14 per gram of liquid scintillation counting medium or of animal tissue. These exceptions would no longer be needed if the TS-R-1 exemption values are adopted, since the TS-R-1 exemption activity concentrations are 1 × 10 6 Bq/g (27 μCi/g) for H-3 and 1 × 10 4 Bq/g (0.27 μCi/g) for C-14. Note, however, that this does not necessarily mean that these materials would be exempt from the provisions of the HMR relating to other hazard classes. Issue 6: Uranium Hexafluoride (UF 6 ) Background. Current regulation for uranium hexafluoride (UF 6 ) packaging and transportation is a combination of NRC and HMR requirements. The HMR contain provisions that govern many aspects of UF 6 packaging and shipment preparation, including a requirement that the UF 6 material be packaged in cylinders that meet the ANSI N14.1 standard. NRC regulates fissile materials and Type B packaging designs for all materials. Since UF 6 is a fissile material, it is also regulated by NRC. Previous editions of the IAEA regulations did not specifically address UF 6 , but TS-R-1 contains detailed requirements for UF6 packagings designed for more than 0.1 kg UF 6 . First, TS-R-1 requires the use of the International Organization for Standardization (ISO) Standard 7195, “Packaging of Uranium Hexafluoride (UF 6 ) for Transport,” instead of the ANSI N14.1 standard, with the condition that approval by all countries involved in the shipment is obtained (i.e., multilateral approval (Paragraph 629)). Second, TS-R-1 requires that all packages containing more than 0.1 kg UF 6 must meet the “normal conditions of transport” drop test, a minimum internal pressure test and the hypothetical accident condition thermal test (Paragraph 630). However, TS-R-1 does allow a competent national authority to waive certain design requirements, including the thermal test for packages designed to contain greater than 9,000 kg UF 6 , provided that multilateral approval is obtained. Third, TS-R-1 prohibits use of packages utilizing pressure relief devices (Paragraph 631). Fourth, TS-R-1 includes a new exception for UF 6 packages, regarding the evaluation of a single package. This new exception (Paragraph 677(b)) allows UF 6 packages to be evaluated without considering the in-leakage of water into the containment system if the packages satisfy certain specified conditions. Under these conditions, a single fissile UF 6 package does not have to be shown to be subcritical under the assumption that there is water inside the containment system. This provision only applies when there is no contact between the valve and any other component of the cylinder under hypothetical accident tests and the valve remains leak-tight following the thermal test, and when there is a high degree of quality control in the manufacture, maintenance, and repair of packagings coupled with tests to demonstrate closure of each package before each shipment. There are specific performance and design requirements for packages containing uranium hexafluoride (paragraphs 629-632), including conformance with ISO Standard 7195, “Packaging of Uranium Hexafluoride (UF 6 ) for Transport.” Competent Authority package design certificates are required for international shipments of uranium hexafluoride (paragraph 828). Discussion. Although many commenters to the ANPRM do not agree with the need or basis of the changes, most of the commenters do agree that we should adopt them to facilitate international transportation of UF 6 . Commenters asked for the following information to be included in the HMR: (1) Clarification of the requirements for new cylinders, cleaned cylinders, and cylinders containing residual amounts of UF 6 (heel cylinders); (2) additional details regarding approval provisions; and (3) transitional or grandfathering provisions. We agree with the need for additional information and are proposing to include all of what was requested. We also recommend that shippers and carriers of UF 6 consult with IAEA Safety Guide TS-G-1.1, “Advisory Material for the IAEA Regulations for the Safe Transport of Radioactive Material,” for further clarification. Accordingly, in this NPRM we are proposing to incorporate the TS-R-1 changes for packagings containing more than 0.1 kg of UF 6 . RSPA also proposes to authorize the use of the 2001 edition of ISO Standard 7195 as an alternative to ANSI N14.1, to require the packagings to meet the pressure, drop and thermal test requirements found in paragraphs 629-632; to prohibit the use of pressure relief devices; and to certify the packagings in accordance with paragraph 828. Issue 7: Air Transport Requirements Background. TS-R-1 has introduced two new concepts for the air transport of radioactive material: the Type C package (paragraphs 230, 667-670, 730, 734-737) and Low Dispersible Material (LDM). Type C packages are designed to withstand severe accident conditions associated with air transport without loss of containment or significant increase in external radiation levels. The LDM is a material exemption to these new air transport standards that is granted based on a material's limited radiation hazard and low dispersibility. If qualified as LDM, material in quantities that would otherwise require a Type C package could continue to be transported by aircraft in a Type B package. U.S. regulations do not contain a Type C package or LDM category, but do have specific requirements for the air transport of plutonium (10 CFR 71.64 and 71.74). These specific NRC requirements for air transport of plutonium will continue to apply. The Type C requirements apply to all radionuclides packaged for air transport that contain a total activity value above 3,000 A 1 or 100,000 A 2 , whichever is less, for special form material, or above 3,000 A 2 for all other radioactive material. Below these thresholds, Type B packages may be used in air transport. The Type C package performance requirements are significantly more stringent than those for Type B packages. For example, a 90-meter per second (m/s) impact test is required instead of the 9-meter drop test. A 60- minute fire test is required instead of the 30-minute for Type B packages. These stringent tests are expected to result in package designs that will survive more severe aircraft accidents than Type B package designs. The LDM specification was added in TS-R-1 to account for radioactive materials (package contents) that have inherently limited dispersibility, solubility, and radiation levels. The test requirements for LDM to demonstrate limited dispersibility, and leachability are a subset of the Type C package requirements (90-m/s impact and 60-minute thermal test) with an added solubility test, and must be performed on the material without packaging. The LDM must also have an external radiation level below 10 mSv/h (1 rem/hr) at 3 meters. Specific acceptance criteria are established for evaluating the performance of the material during and after the tests (less than 100 A 2 in gaseous or particulate form of less than 100 micrometer aerodynamic equivalent diameter and less than 100 A 2 in solution). These stringent performance and acceptance requirements are intended to ensure that these materials can continue to be transported safely in Type B packages aboard aircraft. LDM must be certified as such by the Competent Authority (Paragraphs 803, 804, 828, 830). In 1996, the NRC communicated to the IAEA that the NRC did not oppose the IAEA adoption of the newly created Type C packaging standards (letter dated May 31, 1996, from James M. Taylor, EDO, NRC, to A. Bishop, President, Atomic Energy Control Board, Ottawa, Canada). However, Mr. Taylor stated in the letter that, to be consistent with United States law, any plutonium air transport to, within or over the United States will be subject to the more rigorous U.S. packaging standards. Discussion. A commenter to the 1999 ANPRM asserts that the testing criteria for Type C packages is inadequate. For example, the commenter questions the rigorousness of the testing described in TS-R-1, indicating that the minimum acceptable impact speed should be increased to at least 129 m/s, as was mandated by Congress. Several commenters state that it is unclear what the differences are between a Type B and Type C package and that the definitions should be clarified. Several commenters support the addition of the term LDM and recommend its incorporation into the HMR. Finally, one commenter suggests that the new concept of LDM was introduced to offset the problems encountered in developing a Type C package. The commenter further asserts that the nuclear industry would attempt to certify reprocessed fuel known as MOX as LDM. The commenter believes there are significant safety implications regarding the movement of these substances via transportation by air and very strongly opposes any adoption of requirements in this area. According to the DOT/NRC Memorandum of Understanding, the NRC has responsibility for matters concerning packagings for fissile and greater-than-Type-A quantities of radioactive material. The NRC is proposing not to adopt the concepts of Type C packages or LDM at this time. In accordance with the NRC position, RSPA is not proposing to adopt the IAEA standards for Type C packaging or LDM. Issue 8: Fissile Material Package and Transport Requirements Background. Under the MOU between DOT and NRC, NRC establishes the packaging requirements for the transport of fissile radioactive material. In February 1997, NRC published an emergency final rule (62 FR 5913, February 10, 1997) to amend Part 71 of Title 10 of the Code of Federal Regulations (10 CFR 71) with respect to the regulations for shipping small quantities of fissile material; this rule was issued in response to a regulatory defect in the fissile material exemption regulations in § 71.53 of 10 CFR identified by an NRC licensee. Based on the public comments on the emergency final rule, NRC contracted with Oak Ridge National Laboratory (ORNL) to perform a thorough analysis of the possible hazards involved and to provide recommendations. In July 1998, the NRC published ORNL's conclusions as NUREG/CR-5342, entitled Assessment and Recommendations for Fissile-Material Packaging Exemptions and General Licenses Within 10 CFR Part 71. Based on the research and recommendations of this report, the NRC in its notice of proposed rulemaking to harmonize 10 CFR 71 with TS-R-1, is proposing several changes to its requirements for fissile exemptions. In addition, the NRC is proposing in its NPRM the introduction of a Type B(DP) package, to be certified for use and used both to transport and to store spent nuclear fuel. Such a package would be issued an NRC Certificate of Compliance approving the design of a spent fuel (fissile material) transportation package, in accordance with the requirements of subpart I of 10 CFR 71, and an NRC Certificate of Compliance approving the design of a spent fuel storage cask, in accordance with the requirements of subpart L of 10 CFR 72. Discussion. Several commenters assert that the TS-R-1 requirements for conducting criticality analyses for fissile materials being shipped by air require clarification. The commenters stated that a guidance note should be issued and included in TS-R-2 ( now referred to as TS-G-1.1) when published and the HMR should reflect this clarification. RSPA has no authority to make unilateral changes in IAEA documents. RSPA, in coordination with the NRC, will analyze problems in performing criticality analyses for the shipment of fissile materials by air as they arise; the possibility of issuing a guidance document will be considered if it appears to be an appropriate means to address any problems encountered. These commenters further stated that RSPA should provide clear guidance regarding the requirements for obtaining U.S. Competent Authority Certificates for air transport of fissile materials prior to formal harmonization of TS-R-1 and the HMR. As indicated in Issue 7, the NRC and RSPA do not propose to adopt TS-R-1 provisions for Type C packages or LDM. The practical consequence of this is that RSPA's Office of Hazardous Materials Safety, as U.S. Competent Authority, does not intend to issue Certificates of Competent Authority for Type C packages or LDM. Other Certificates of Competent Authority for the international transport of fissile materials by air will be issued following normal procedures described in §§ 173.471 and 173.473. Accordingly, in this NPRM we propose to adopt the NRC fissile material exemption provisions in § 173.453, and to introduce the Type B(DP) package proposed by the NRC in its NPRM. We propose to remove the definition of “fissile material, controlled shipment,” and to revise § 173.457 and § 173.459 to remove the references to “fissile material, controlled shipment” and to base requirements for non-exclusive use and exclusive use shipments of fissile material packages on TS-R-1 package and conveyance CSI limits, since we feel that this would considerably simplify the transport of fissile material packages, while maintaining appropriate criticality safeguards. Issue 9: Transitional Requirements Background. Transitional requirements typically authorize: (1) Continued use of existing package designs and packagings already fabricated, although some additional requirements may be imposed; (2) completion of packagings that are in the process of being fabricated or that may be fabricated within a given time period after the regulatory change; and (3) limited modifications to package designs and packagings without the need to demonstrate full compliance with the revised regulations, provided that the modifications do not significantly affect the safety of the package. Each transition from one edition of the IAEA regulations to another (and the corresponding revisions of the NRC and DOT regulations) included transitional provisions. The transitional provisions in TS-R-1, the latest version, are found in paragraphs 815-818. Although provisions for continued use of packages and special form sources previously approved in accordance with the 1973 and 1985 editions of the IAEA regulations remain virtually unchanged, TS-R-1 does not provide transitional provisions for packages approved under the 1967 edition of the IAEA regulations. The restrictive TS-R-1 transitional provisions will have several impacts. The primary impact of these two paragraphs is that Safety Series No. 6 (1967) approved packagings are no longer authorized. The second impact is that fabrication of packagings designed and approved under Safety Series No. 6 (1985/1985A) must be completed by a specified date. In TS-R-1, packages approved for use based on Safety Series No. 6 (1973/1973A revisions) will continue to be authorized for use and can continue to be used through their design life, provided they meet the following conditions: (1) multilateral approval is obtained; (2) TS-R-1 quality assurance requirements are adhered to; (3) TS-R-1 A 1 and A 2 activity values are used; and, (4) if applicable, approval for air transport of fissile radioactive material is obtained. While existing packagings are still authorized, no new packagings may be fabricated to this design standard. Should a safety issue associated with the package be identified, this packaging will need to meet all of the applicable requirements of TS-R-1. In summary, a packaging designed to Safety Series No. 6 (1973/1973A) can continue to be used. In similar fashion, TS-R-1 states that those packages approved for use based on Safety Series No. 6 (1985/1985A revisions) may continue to be used, provided the packaging meets the following conditions: (1) TS-R-1 quality assurance requirements, (2) TS-R-1 A 1 and A 2 activity values, and, (3) if applicable, approval for air transport of fissile radioactive material. After December 31, 2003, use of these packages may continue under multilateral approval. Should a safety issue associated with the package be identified, the packaging will need to meet all of the applicable requirements of TS-R-1. Additionally, use of this packaging will end on December 31, 2006. Beginning January 1, 2007, all packagings will be required to meet TS-R-1 packaging approval requirements. Discussion. Commenters to the ANPRM generally state that some type of transitional arrangements should be provided in the HMR to clarify how packages manufactured under earlier versions of Safety Series 6 will be phased out, and how and if these packages may be re-validated. One commenter suggests that we should provide a transition period prior to the full adoption of TS-R-1 that would provide shippers and carriers the flexibility to make shipments of radioactive materials under the current HMR requirements (equivalent to Safety Series 6) or under TS-R-1. Several commenters state that for domestic shipments, we should provide a one-year transition period for complete implementation of the TS-R-1 regulations. Other commenters suggest that we incorporate the following statement into the HMR: “Packages that have been prepared for transport prior to (five-year effective date) may be offered for transport provided that the labeling, marking, and placarding provisions of the regulations in effect at time of shipment are complied with.” We do not agree that the HMR should adopt the above suggestions. Radioactive material transport regulations in the HMR apply only to domestic transport and to the domestic portion of import and export shipments. Because the international modal organizations IMO and ICAO have adopted TS-R-1, international shipments must follow TS-R-1 requirements. Accordingly, in this NPRM, we propose to accept the IAEA transitional requirements and will begin the phase out of its Type B specification packages. We propose that manufacture of all Type B specification packages conforming to Safety Series 6 for radioactive material be prohibited as of the date of implementation of this rule and that use of these packages be prohibited two years after implementation of this rule. Issue 10: Other TS-R-1 Changes We propose to add a requirement that the active material in an instrument or article intended to be transported in an excepted package be completely enclosed by the non-active components. This is a requirement which appears in paragraph 517(c) of TS-R-1, and is a change from the wording in Safety Series No. 6. It is intended to enhance the safety of shipments of instruments or articles in excepted packages by making it explicit that the radioactive contents in such an instrument or article must be completely enclosed by the non-radioactive material of which the instrument or article is constructed in order to prevent release of the active contents under normal conditions of transport. III. Section-by-Section Review Part 171 Section 171.7 In the table of material incorporated by reference, we are proposing to remove the DOE Uranium Hexafluoride Good Practices manual, the1985 IAEA Regulations for the Safe Transport of Radioactive Material, Safety Series No. 6. and an ISO standard entry, revise the IAEA Regulations for the Safe Transport of Radioactive Material, No. TS-R-1, 1996 Edition and two ISO standard entries, and add three new entries consisting of two ISO standards and a United States Enrichment Corporation Good Handling Practices for Uranium Hexafluoride. Section 171.11 In HM-215D, [66 FR 33336], we added a paragraph to §§ 171.11 and 171.12 to clarify that only the current definition of radioactive material applies (i.e., 70 Bq/g (0.002 microcurie/g)) when transporting a Class 7 (radioactive) material domestically. In addition, we maintained the current provisions in §§ 171.11 and 171.12, including the values for Type A packaging contents. Therefore, in § 171.11, we are proposing to remove paragraph (d)(6)(vi) that limits the Class 7 (radioactive) material to the current definition in § 173.403. This would allow for the proposed adoption of the current edition of the IAEA regulations for both domestic and international shipments. To clarify that the exceptions described in § 173.422 apply to instruments or articles containing natural uranium or thorium, and empty packagings, as well as limited quantities of radioactive material, we are also proposing to change the phrase “limited quantities” in § 171.11(d)(6)(ii) and (iv) to “excepted packages.” Section 171.12 In § 171.12, we propose to revise paragraphs (d) introductory text and (d)(4) to remove the reference to Safety Series No. 6, 1985 edition and replace it with TS-R-1, 1996 edition. In addition, we propose to remove paragraph (d)(7) that limits the Class 7 (radioactive) material definition to the current definition in § 173.403. This would allow for the proposed adoption of the current edition of the IAEA regulations for both domestic and international shipments. Part 172 Section 172.101 In the Hazardous Materials Table, we propose to revise the radioactive material (Class 7) entries consistent with new entries introduced in the UN Recommendations and IAEA's “Regulations for the Safe Transport of Radioactive Material, No. TS-R-1” to allow for both domestic and international shipment. In addition, we propose to remove those radioactive material entries that currently allow for domestic shipment only. Section 172.203 In paragraph (d) we propose to remove two requirements that would become redundant upon adoption of the new proper shipping names: (1) Paragraph (d)(1) requiring that the words “Radioactive Material” be entered on the shipping paper unless already contained in the proper shipping name, and (2) paragraph (d)(11) requiring that for a shipment of low specific activity material or surface contaminated objects, the appropriate group notation of LSA-I, LSA-II, LSA-II, SCO-I, or SCO-II be entered in the shipping description. In addition, we are proposing to revise paragraph (d)(4) to require that customary units, if used, be enclosed in parentheses. Because the isotope plutonium-238 has been removed from the definition of fissile material, we propose to revise paragraph (d)(4) to remove plutonium-238 from the list of fissile radionuclides for which the weight in grams or kilograms may be listed instead of or in addition to the activity. Paragraphs (d)(7)(ii) and (d)(7)(iii) would be redesignated (d)(7)(iii) and (d)(7)(iv), and a new paragraph (d)(7)(ii) would be added to require inclusion of the criticality safety index in the shipping description for fissile material packages. Paragraphs (d)(2) through (d)(10) would be redesignated (d)(1) through (d)(9). A new paragraph (d)(10) would be added to require the words “Highway route controlled quantity” on a package containing a highway route controlled quantity of Class 7 (radioactive) materials. Section 172.301 We propose to revise paragraph (a)(1) to include the UN identification number marking requirement for excepted packages of Class 7 (radioactive) materials. Section 172.310 We are proposing to revise paragraph (b) to require industrial packagings to be marked Type IP-1,” “Type IP-2,” or “Type IP-3,” as appropriate. We propose to revise paragraph (c) to remove the reference to Type B package designs, and to bring the wording into closer correspondence to that in TS-R-1. We further propose to redesignate paragraphs (c) and (d) as (d) and (e), and to add a new paragraph (c) to require the outside of a Type IP-2, Type IP-3 or Type A packaging to be marked with the international vehicle registration code of the country of origin of design. Section 172.400 For fissile material packages, TS-R-1 (paragraph 218) introduced the concept of a CSI to replace the “TI for criticality control purposes,” in use until now, and decoupled it from the determination of the TI for such a package. The CSI must be displayed on shipments of fissile material (paragraphs 544 and 545) using a new “FISSILE” label. The redefined TI is determined in the same way as the “TI for radiation control purposes” and continues to be displayed on the traditional “radioactive material” label. Therefore, we propose to revise the table in § 172.400 to add the new “FISSILE” label. Section 172.402 Paragraph (d) would be revised to require each package containing fissile material, other than fissile excepted, to bear the new FISSILE label. (See discussion under § 172.400 above.) Section 172.403 We propose to add a new paragraph (e) to require each FISSILE label to be completed with the CSI. (See discussion under § 172.400 above.) Paragraph (g)(2) would be revised to require that customary units, if used, be enclosed in parentheses. Because the isotope plutonium-238 has been removed from the definition of fissile material, we are also proposing to revise paragraph (g)(2) to remove plutonium-238 from the list of fissile radionuclides for which the weight in grams or kilograms may be listed instead of or in addition to the activity. For convenience to the reader, we propose to add a new paragraph (h) to incorporate the requirements presently in § 173.448(g) pertaining to the labeling of overpacks, and to add a clarification that the label category for the overpack must be determined using the maximum surface radiation level of the interior package(s) unless the overpack qualifies as an appropriate package type for its contents. Section 172.441 We are proposing to add a new § 172.441 to identify the specification requirements for the new “FISSILE” label. (See discussion under § 172.400 above.) Part 173 Section 173.401 We are proposing to revise paragraphs (b)(2) and (b)(3) for clarity. In addition, we propose to add new paragraph (b)(4) to expand upon those areas when the HMR would not apply by including under specific conditions Class 7 (radioactive) material in natural material and ores containing naturally occurring radionuclides, respectively. In regard to paragraph (b)(2), the proposed language accurately and more succinctly reflects the present contents of § 173.401(b)(2) and (b)(3). In regard to paragraph (b)(3) the proposed language is intended to codify actual practice. In regard to paragraph (b)(4), the proposed language is intended to except from the HMR the majority of shipments of ores and materials that contain naturally occurring radionuclides, but that are to be used to produce materials whose benefits lie in their non-radiological qualities (such as coal, gypsum, phosphates, non-radioactive metals, etc.). The upper limit of 10 times the activity concentration or consignment activity thresholds assures that worker and public doses will remain small from these unregulated materials, while the exemption permits their continued use in commerce without making that use economically unfeasible. Section 173.403 We propose to revise this section by removing the definitions for “Non-fixed radioactive contamination,” and “Fissile material, controlled shipment,” and revising the definitions for “Exclusive use,” “Fissile material,” “Low Specific Activity (LSA) material,” “Low toxicity alpha emitters,” “Maximum normal operating pressure,” “Multilateral approval,” “Package,” “Radioactive contents,” “Radioactive material,” “Special form Class 7 (radioactive) material,” “Surface Contaminated Object (SCO),” “Transport Index (T)(I),” “Unilateral approval,” “Unirradiated uranium,” and “Uranium—natural, depleted, or enriched.” New definitions for “Consignment,” “Contamination,” “Criticality Safety Index (CSI),” “Exemption value”, and “Quality assurance” would be added. The following definitions would be removed: Non-fixed radioactive contamination. We propose to remove this definition but its essential elements would be added to the definition of “contamination” for clarity. (See discussion under the definition for contamination below.) Fissile material, controlled shipment. We propose to remove this definition as part of the revision of §§ 173.457 and 173.459 of this subchapter, in order to simplify the requirements for transporting fissile material. The following definitions would be revised: Exclusive use. We propose to clarify that a vehicle survey is required under certain circumstances after use. Fissile material. We propose to revise this definition for consistency with TS-R-1 and to include uranium-233, uranium-235, plutonium-239, plutonium-241, or any combination of these radionuclides. Plutonium-238 would be removed from the definition of “fissile material,” because plutonium-238 is only fissionable, not fissile. It refers only to the fissile radionuclides themselves and does not include the non-fissile material containing these fissile radionuclides. Low Specific Activity (LSA) material. We propose to revise the definition of LSA-I to allow shipments of very low specific activity materials containing one or more of a variety of radionuclides, and to remove the present category which refers to mill tailings, contaminated earth, concrete, rubble, other debris, and activated material in which Class 7 (radioactive) material is essentially uniformly distributed and the average specific activity does not exceed 10 −6 A 2 /g. Low toxicity alpha emitters. This definition would be revised for consistency with TS-R-1 and primarily includes physical and chemical concentrates in addition to natural uranium, depleted uranium, natural thorium, uranium-235, uranium-238, thorium-228 and thorium-230 when contained in ores; or alpha emitters with a half-life of less than 10 days. Maximum normal operating pressure. We propose to revise this definition to align the HMR with the wording in TS-R-1 and 10 CFR 71.4. Multilateral approval. We propose to revise this definition for clarity by adding the word “design.” The Competent Authority approval for a package is actually for the package design. Package. We propose to revise this definition for clarity. The definitions of each package type in § 173.403 include the requirements they must satisfy if their contents are not fissile. Therefore, we are proposing to include the caveat that if the contents are fissile, additional requirements must be satisfied. In addition, the definitions of types of packages would be rearranged, to put the package types in an order more closely reflecting their increased capability to retain the contents under normal, as well as hypothetical accidental, conditions of transportation. Finally, the revision of the definition of Package would include the addition of the definition for the proposed NRC Type B(DP) package. Radioactive contents. We propose to revise this definition to be consistent with TS-R-1. Radioactive material. We propose to revise this definition to be consistent with TS-R-1. Currently, we use a specific activity threshold of 70 Bq/g (0.002 microcurie/g) for defining a material as radioactive for transportation purposes. The HMR applies to all radioactive materials with specific activities above this value. Therefore, radioactive materials with specific activities equal to or below this value are not regulated. The 70 Bq/g specific activity value is applied collectively for all radionuclides present in a material; i.e., if a chain of radionuclides is present, the sum of the activities of all radionuclides in the chain is to be compared with 70 Bq/g. During the development of TS-R-1, it was recognized that there is no technical justification for the use of a single activity-based exemption (70 Bq/g) value for all radionuclides. As a result, it was concluded that a more rigorous technical approach would be to base radionuclide exemptions on a uniform dose basis, rather than a uniform specific activity (also known as activity concentration) basis. (Please refer to a more detailed discussion of this in Section II of this notice under Issue No. 1.) Special form Class 7 (radioactive) material. We propose to revise this definition to be consistent with TS-R-1. Surface Contaminated Object (SCO). We propose to revise this definition for clarity. Transport Index. We propose to revise this definition consistent with TS-R-1. This is the number which is used to provide control over radiation exposure and is assigned to a package, overpack or freight container, or to unpackaged LSA-I or SCO-I. Unilateral approval. We propose to revise this definition by adding the word “design.” The Competent Authority approval for a package is actually for the package design. Unirradiated uranium. We propose to revise this definition to be consistent with TS-R-1. Uranium—natural, depleted, or enriched. We propose to revise this definition for clarity. Minor word and number changes, in addition to clarifying that “natural uranium” does not refer to ores, and that all unirradiated uranium contains a small amount of uranium-234. We propose to add the following definitions: Consignment. We propose to add this definition to clarify to what total quantity of radioactive material the consignment activity exemption values are to be applied. Contamination. We propose to add this definition for consistency with TS-R-1. The proposed definition includes the definitions for “fixed radioactive contamination” and “non-fixed radioactive contamination.” The quantitative definition of contamination is in Safety Series No. 6, 1985 Edition (As Amended 1990) as well as TS-R-1; it was inadvertently omitted in the previous harmonization rulemaking (HM-169A, September 28, 1995). The consequence would be that non-radioactive materials with radioactive substances on the surface in levels below those listed in the definition for contamination would not be considered radioactive for purposes of transportation. Criticality Safety Index (CSI). This definition would be added to be consistent with TS-R-1. The introduction of the CSI is intended to simplify the representation on labels, and in shipping papers of a package's criticality hazard and its radiation hazard by using separate numbers to describe the two. Currently, the TI serves a dual role, in that for fissile packages a TI is determined for the radiation hazard, another for the criticality hazard, and then the final TI assigned to the packages is the greater of the two. The introduction of the CSI permits the use of the TI exclusively for describing the radiation hazard. This reduces the uncertainty inherent in not knowing whether the TI value is because of one hazard or the other, and should aid shippers, carriers, and emergency responders in understanding the hazards associated with a radioactive materials package. Exemption value. This definition would be added to clarify that the phrase refers to the activity concentration or consignment activity thresholds above which a material would be considered sufficiently radioactive to be subject to the HMR, and to distinguish if from a DOT exemption, defined in § 171.8. Fissile material package. This definition would be added to clarify that Type AF package, Type BF package, Type B(U)F package, Type B(M)F package, or fissile material package means a fissile material packaging together with its fissile material contents. Fixed radioactive contamination. This definition would be added to be consistent with TS-R-1. (See discussion under the definition for “contamination” above.) Quality assurance (QA). This definition would be added to be consistent with TS-R-1. We currently require evidence of a QA program for issuing Certificates of Competent Authority, but do not define it, except to indicate that a USNRC approved program is acceptable, or also that adhering to §§ 173.474 and 173.475 is acceptable for export of DOT Specification packages. Therefore, the introduction of the TS-R-1 definition would clarify what we mean by a QA program, and call attention to the fact that this is something we associate with radioactive material transport. Section 173.411 We propose to revise paragraph (b)(5)(ii) to correct the reference to the ISO Standard 1496. As described in the 1985 Edition of Safety Series No. 6 and in TS-R-1, the reference should be to Part 1, Cargo Containers, instead of Part 3, Tank Containers. Section 173.415 We propose to revise paragraph (a) to clarify that after April 1, 1997, the use of Specification 7A packagings designed in accordance with the requirements of § 178.350 in effect on October 1, 1996 would continue to be authorized. Section 173.416 We propose to remove paragraphs (d), (e) and (f) to discontinue the use of DOT Specification 20WC and 21WC as authorized Type B packaging. We also propose to revise paragraph (c) to discontinue the use of DOT Specification 6M as an authorized Type B package, and to specify that 2 years after the effective date of the final rule, these DOT Specification packages may no longer be used. Section 173.417 We propose to remove paragraphs (a)(1), (a)(2), (a)(6), (b)(1) and (b)(2) to discontinue the use of DOT Specification 6L, 6M and 1A2 as authorized fissile materials packagings. We also propose to add a new paragraph (c) to specify that 2 years after the effective date of the final rule, these packages may no longer be used. Tables 2, 4, and 5 would be removed. Tables 3 and 6 would be redesignated as Tables 2 and 3, respectively. Paragraphs (a)(3), (a)(4), (a)(5), (a)(7) and (a)(8) would be redesignated as (a)(1) through (a)(5), respectively, and (b)(3), (b)(4), and (b)(5) as (b)(1) through (b)(3). The new paragraphs (a)(3) and (b)(2) would have the references to Safety Series No. 6 changed to No. TS-R-1. The new paragraph (a)(4) would be revised to include the greater than 0.1 kg of uranium hexafluoride provision. The proposed NRC Type B(DP) packaging would be added to new paragraph (b)(1), and Type B packagings would be removed from the new paragraphs (a)(2), (a)(3), (b)(1) and (b)(2). Section 173.420 We propose to revise § 173.420 to introduce new performance packaging requirements for packagings containing more than 0.1 kg of UF 6 to include ISO Standard 7195 as an alternative to American National Standard N14.1. Section 173.421 We propose to revise paragraph (a) to indicate that an excepted package of a limited quantity of Class 7 (radioactive) material is not excepted from all marking requirements. Section 173.422 Consistent with the new marking provisions for excepted packages containing radioactive materials in TS-R-1, we propose to eliminate the requirement in § 173.422(a) for a certification statement for such packages. In addition, we are proposing to add the requirement that excepted packages be marked with the UN identification number, and to remove the reference to § 173.423, since § 173.422 deals with Class 7 (radioactive) material classed as Class 7, while § 173.423 refers only to multiple hazard limited quantity Class 7 (radioactive) materials. Section 173.424 We propose to revise § 173.424 to indicate that an excepted package containing a radioactive instrument or article is not excepted from all marking requirements. In addition, we propose to require each instrument or article, except radio luminescent time-pieces or devices, to be transported in an excepted package bearing the marking “RADIOACTIVE,” and that the active material in an instrument or article containing radioactive material be completely enclosed by the non-active components. Section 173.426 We propose to revise § 173.426 to indicate that excepted packages of articles containing natural uranium or thorium are not excepted from all marking requirements. Section 173.427 We propose to revise § 173.427 to clarify: (1) LSA/SCO transportation and packaging requirements; (2) that fissile LSA is prohibited; i.e., that material containing fissile radionuclides may be classified as LSA only if it satisfies one of the sets of conditions in § 173.453 to be considered fissile-excepted material; and (3) exclusive use requirements and provisions. In addition, we are also proposing to revise this section to authorize the transportation of unpackaged LSA-I and SCO-I material, and to remove the present exception for LSA material and SCO conforming to the provisions specified in 10 CFR 20.2005. Section 173.428 We propose to revise § 173.428 to include a requirement for marking an empty package with the UN identification number. We propose to redesignate paragraphs (c), (d) and (e) as (d), (e) and (f). In addition, we propose to add a new paragraph (c) to require that the outer surface of any uranium or thorium component of a radioactive materials package intended to be shipped as an empty package be covered by an inactive sheath. This is a safety improvement, and makes this requirement consistent with that in TS-R-1 for the transport of empty radioactive material packages. Section 173.431 We propose to revise paragraph (b) to remove the reference to a Type B package. Section 173.433 We propose to revise § 173.433 to reference the nuclide-specific exemption values, and clarify how these may be calculated for mixtures. We also propose to revise the wording to reflect more closely the wording in TS-R-1, and to incorporate the TS-R-1 expression for determining the limits on activities of radionuclides which may be transported in a Type A package when some of the material is in special form and some in normal form. Section 173.435 We propose to replace the present “Table of A 1 and A 2 values for radionuclides,” with accompanying footnotes, with the A 1 and A 2 values and accompanying footnotes from Table I of TS-R-1. The exception to allow the domestic transport of up to 20 Ci of Mo-99 in a Type A package would be retained. In addition, the Safety Series No. 6 values of A 1 and A 2 would be retained for Cf-252. Section 173.436 In accordance with our proposal to adopt the nuclide-specific exemption values found in TS-R-1, we propose to add a new § 173.436 to contain a table entitled “Exempt material activity concentrations and exempt consignment activity limits for radionuclides.” This table, along withaccompanying footnotes, would be taken from Table I of TS-R-1. Section 173.441 The title would be revised to include exclusive use provisions. Paragraph (d) would be redesignated paragraph (e). A new paragraph (d) would be added in order to assemble in one location the total TI restrictions for non-exclusive use and exclusive use shipments, and storage in transit, of Class 7 (radioactive) materials. Section 173.443 We propose to revise Table 11, in § 173.443 to list the true non-fixed contamination limits for the outer surfaces of packages. In addition, we propose to revise paragraph (a)(1) to indicate that in calculating the contamination level from the activity measured on the wipe, the true wipe efficiency must be used or a default efficiency of 0.10 may be assumed. Section 173.448 We propose to revise § 173.448 to remove the requirements in § 173.448(g)(1) for the labeling of overpacks and relocate them to § 172.403(h). Relocating the requirements for the labeling of overpacks to § 172.403(h) is more logical and should aid the reader. Section 173.453 We propose to revise § 173.453 to be consistent with the new fissile material exceptions included in NRC rulemaking. Section 173.457 We propose to simplify the requirements for transporting fissile material packages by incorporating in § 173.457 the TS-R-1 concept of CSI and TS-R-1 CSI limits, and by eliminating the concept of “fissile material, controlled shipment,” which was originally developed to control transport of Fissile Class III materials, under a now obsolete scheme for classifying fissile material packages. Because all fissile material transport is now limited by the total CSI which may be carried on a conveyance, this concept is no longer needed. Section 173.459 We propose to revise § 173.459(a) to replace the reference to the criticality control transport index with the criticality safety index. With the elimination of the concept of “fissile material, controlled shipment” and the inclusion of the total TI limits in § 173.441 and total CSI limits in § 173.457, we propose to remove § 173.459(b) and (c), that refer to circumstances under which a shipment would become a fissile material, controlled shipment. Because the total CSI conveyance limits provide adequate safeguards against criticality, these paragraphs are no longer needed. Section 173.469 To allow for the substitution of the Class 4 impact test from ISO 2919-1980(E) for the basic impact and percussion tests, we propose to revise paragraph (d)(1) to include the TS-R-1 restriction that the sealed capsule and contents have a mass less than 200 g. In addition, we propose to revise the reference for the alternate leak test methods in paragraph (a)(4)(ii) from ISO/TR 4826-1979(E) to ISO 9978-1992(E), and other minor revisions of syntax would be incorporated in this section to reflect more accurately the wording of TS-R-1. Section 173.471 We propose to revise the introductory text to remove Type B as a sub-class of NRC approved packages, since the NRC no longer issues certificates for this sub-class. Section 173.473 We propose to revise the introductory text to clarify the types of foreign-made packages that would require certification, and to change the reference to Safety Series No. 6 to that for No. TS-R-1. Section 173.476 We propose to revise paragraph (c)(4) to specify what the required quality assurance program should cover. In addition, we propose to add a new paragraph (c)(5) to require that a description of any planned pre-shipment actions for use in the consignment of special form radioactive material be included in an application for a U.S. Competent Authority Certificate for Special Form Material. The former is in Safety Series No. 6, 1985 Edition, but never included in the HMR; the latter is new to TS-R-1. Section 173.477 We propose to add a new § 173.477 to define the approval requirements for packagings containing more than 0.1 kg of UF 6 . Part 174 Section 174.700 We propose to revise paragraph 174.700(b) to reflect the fact that the upper TI limit of 50 refers to both the total TI and the total CSI for non-exclusive use shipments. In addition, we propose to add a new paragraph (d) to emphasize that the appropriate transport restrictions for fissile material packages apply to transport by rail. Part 175 Section 175.700 We propose to revise paragraph (a) by adding a requirement to limit the CSI to a maximum of 3.0 for a fissile material package transported in a passenger carrying aircraft; this is necessary because under TS-R-1 the historical limitation of 3.0 TI on a passenger carrying aircraft would only limit the radiation hazard and not the criticality hazard. In addition, we propose to add a new paragraph (e) to ensure that on a passenger aircraft neither the total TI nor the total CSI exceeds 50. Section 175.702 We propose to revise § 175.702 to include the requirements for non-exclusive use cargo aircraft only, based on the separate TS-R-1 limits on total transport index and total criticality safety index. Section 175.703 We propose to add a new paragraph (c) to emphasize that the appropriate transport restrictions for fissile material packages also apply to transport by air. Current paragraphs (c), (d), and (e) would be redesignated paragraphs (d), (e), and (f) respectively, and the redesignated paragraph (d) would be revised to replace the reference to fissile material, controlled shipment with requirements for exclusive use shipments by air. Part 176 Section 176.700 We propose to remove paragraph (c) due to the proposed elimination of the term “fissile material, controlled shipment. Paragraphs (d) and (e) would be redesignated (c) and (d) respectively. In addition, the requirement that groups of radioactive material packages containing fissile material be separated by at least 6 m (20 feet) from all other such groups would be moved to § 176.704. Section 176.704 We propose to revise § 176.704 including the section title to reflect the introduction of additional transportation controls based on the criticality safety index for fissile material packages, and the decoupling of package controls according to transport indexes and criticality safety indexes. We also propose to replace Table III with Table IIIA to list “Transport Index Limits” and Table IIIB for the “Criticality Safety Index Limits.” In addition, we propose to add to this section the requirement that groups of radioactive material packages containing fissile material be separated by at least 6 m (20 feet) from all other such groups (see discussion under § 176.700 ). Section 176.708 We propose to revise § 176.708 to provide a more detailed dose rate guidance pertaining to an alternate method for determining segregation distances, in accordance with the requirements of the latest IMDG Code. We also propose to restrict the use of this alternate method to the case of exclusive use shipments, for which the proposed § 176.704(f) requires a radiation protection program approved by the competent authority of the flag state of the vessel. Part 177 Section 177.842 In § 177.842, in paragraph (g), a reference to transport index for fissile material packages would be replaced by one to criticality safety index. Part 178 Section 178.350 In § 178.350, paragraph (b) would be revised to remove the wording “and Radioactive Material” from the marking requirement. It is duplicative since all proposed proper shipping names include the words “Radioactive Material.” In addition, we propose to add a new paragraph (c) to require that each Specification 7A package be marked with the manufacturer's or offeror's name. Section 178.352 As a result of our proposal to discontinue the use of DOT Specification 6L metal packagings as an authorized fissile material packaging, we propose to remove in its entirety § 178.352. Section 178.354 As a result of our proposal to discontinue the use of DOT Specification 6M metal packagings as an authorized Type B and fissile material packaging, we propose to remove in its entirety § 178.354. Section 178.362 As a result of our proposal to discontinue the use of DOT Specification 20WC wooden protective jacket as an authorized Type B packaging, we propose to remove in its entirety § 178.362. Section 178.364 As a result of our proposal to discontinue the use of DOT Specification 21WC wooden-steel protective overpack as an authorized Type B packaging, we propose to remove in its entirety § 178.364. IV. Regulatory Analyses and Notices A. Executive Order 12866 and DOT Regulatory Policies and Procedures This proposed rule is not considered a significant regulatory action under section 3(f) of Executive Order 12866 and, therefore, was not reviewed by the Office of Management and Budget. The proposed rule is not considered a significant rule under the Regulatory Policies and Procedures of the Department of Transportation [44 FR 11034]. In consideration of the proposed changes in this notice, we looked to the “Draft Regulatory Analysis of Major Revision of 10 CFR Part 71” NUREG/CR-6713, dated March 2001 prepared for the Nuclear Regulatory Commission (NRC) in support of its related notice of proposed rulemaking. A copy of that document is available for review in this docket (RSPA-99-6283). Potential benefits identified in this NPRM include enhanced safety resulting from the consistency of domestic and international requirements for transportation of radioactive materials. In addition, the proposed changes should permit continued access to foreign markets by domestic shippers of radiopharmaceuticals and other radioactive materials. The NUREG/CR-6713 analysis of regulatory proposals concerning revisions to packaging standards, including the phased elimination of certain DOT specification packagings (e.g., DOT 6L, 6M, 20WC and 21WC) in favor of NRC approved packagings indicates that none of the evaluated changes (individually or collectively) are expected to result in significant economic impacts to NRC licensees. We believe the same holds true for all other shippers, e.g., contractors performing work in support of the Department of Defense and the Department of Energy. One area that has the greatest potential for substantially increased costs to shippers of radioactive materials, concerns large stocks of depleted uranium hexafluoride (UF 6 ) stored in currently authorized packagings at three different locations. If it is eventually determined that this material should be moved off-site to one or more conversion facilities, then it is likely that the current packagings will not meet the standards proposed in this NPRM. [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%3A02-8143. Public record. Not legal advice.