# Hazardous Materials Regulations; Compatibility With the Regulations of the International Atomic Energy Agency

- **operation:** document
- **citation:** 67 FR 21328
- **title:** Hazardous Materials Regulations; Compatibility With the Regulations of the International Atomic Energy Agency
- **source type:** rulemaking
- **agency:** Research and Special Programs Administration
- **status:** proposed
- **official:** true
- **published on:** 2002-04-30
- **effective on:** Not available
- **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.
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Federal Register, Volume 67 Issue 83 (Tuesday, April 30, 2002) [Federal Register Volume 67, Number 83 (Tuesday, April 30, 2002)] [Proposed Rules] [Pages 21328-21388] From the Federal Register Online via the Government Publishing Office [ www.gpo.gov ] [FR Doc No: 02-8143] [[Page 21327]] ----------------------------------------------------------------------- Part II Department of Transportation ----------------------------------------------------------------------- Research and Special Programs Administration ----------------------------------------------------------------------- 49 CFR Part 171, et. al. Hazardous Materials Regulations; Compatibility with the Regulations of the International Atomic Energy Agency; Proposed Rule Federal Register / Vol. 67, No. 83 / Tuesday, April 30, 2002 / Proposed Rules [[Page 21328]] ----------------------------------------------------------------------- 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: [[Page 21329]] 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; [[Page 21330]] Revise Sec. 173.453 to reflect the NRC ``fissile material exemption provisions,'' to remove the definition of ``fissile material, controlled shipment,'' and to revise Sec. 173.457 and Sec. 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 Ci/g) for defining a material as radioactive for purposes of transportation (see definition of radioactive material in Sec. 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 Sv (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 Sv (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 x 10 x and 3 x 10 x+1 would be replaced in the BSS tables by 1 x 10 x+1 . By determining the exemption values for each radionuclide so that they correspond to a single annual dose of 10 Sv (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 [[Page 21331]] 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 Sv (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 Sv, 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 Sv (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 Sv (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 Sv (0.3 mrem) for C-14 to about 420 Sv (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 Sv (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 [[Page 21332]] members of the public more equitably, around a value corresponding to an annual dose of approximately 230 Sv (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 Sv (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 (Sec. 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 Ci/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. [[Page 21333]] 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 Sec. 173.421 or Sec. 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 regu
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