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

- **operation:** document
- **citation:** 69 FR 3632
- **title:** Hazardous Materials Regulations; Compatibility With the Regulations of the International Atomic Energy Agency
- **source type:** rulemaking
- **agency:** Research and Special Programs Administration
- **status:** historical
- **official:** true
- **published on:** 2004-01-26
- **effective on:** 2004-10-01
- **summary:** In this final rule RSPA is amending 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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- **source url:** https://www.federalregister.gov/documents/2004/01/26/04-67/hazardous-materials-regulations-compatibility-with-the-regulations-of-the-international-atomic
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Federal Register, Volume 69 Issue 16 (Monday, January 26, 2004) [Federal Register Volume 69, Number 16 (Monday, January 26, 2004)] [Rules and Regulations] [Pages 3632-3696] From the Federal Register Online via the Government Publishing Office [ www.gpo.gov ] [FR Doc No: 04-67] [[Page 3631]] ----------------------------------------------------------------------- Part II Department of Transportation ----------------------------------------------------------------------- Research and Special Programs Administration ----------------------------------------------------------------------- 49 CFR Parts 171, 172, et al. Hazardous Materials Regulations; Compatibility With the Regulations of the International Atomic Energy Agency; Final Rule Federal Register / Vol. 69, No. 16 / Monday, January 26, 2004 / Rules and Regulations [[Page 3632]] ----------------------------------------------------------------------- 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: Final rule. ----------------------------------------------------------------------- SUMMARY: In this final rule RSPA is amending 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: Effective Date: The effective date of these amendments is October 1, 2004. Voluntary Compliance Date: RSPA is authorizing voluntary compliance with the amendments adopted in this final rule beginning February 25, 2004. However, RSPA may further revise this rule as a result of appeals it may receive for this rule. Incorporation by Reference Date: The incorporation by reference of publications listed in this final rule has been approved by the Director of the Federal Register as of October 1, 2004. 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. Overview of Changes in this Final Rule A. Summary of Amendments B. 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: Other Changes III. Section-By-Section Review IV. Regulatory Analyses and Notices A. Executive Order 12866 and DOT Regulatory Policies and Procedures B. Executive Order 13132 C. Executive Order 13175 D. Regulatory Flexibility Act, Executive Order 13272, and DOT Regulatory Policies and Procedures E. Paperwork Reduction Act F. Regulation Identifier Number (RIN) G. Unfunded Mandates Reform Act H. Environmental Assessment I. Privacy Act 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 (HMR; 49 CFR Parts 171-180) 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 final rule, 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 final rule addresses only the areas over which DOT has jurisdiction as defined in the MOU. Comments received on non-DOT issues [[Page 3633]] or on DOT issues not in the scope of this rulemaking will not be addressed in this rule. 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 of radioactive materials. Additionally, we retained Safety Series No. 6 with the same restrictions. This final rule will address the adoption of TS-R-1 (instead of Safety Series No. 6) requirements into the HMR for domestic use. On April 30, 2002, we published a notice of proposed rulemaking (NPRM) under Docket HM-230 (67 FR 21328). The major changes to the HMR proposed in the NPRM included the following: (1) 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; (2) Adopt the new proper shipping names and UN identification numbers, except for those referring to Type C packages, to fissile low specific activity (LSA) materials or to fissile surface contaminated objects (SCO); (3) Require, 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 the International System of Units (SI units); (4) Incorporate the TS-R-1 changes for packagings containing more than 0.1 kg of UF 6 ; (5) Authorize the use of the 1993 edition of International Organization for Standardization (ISO) 7195 as an alternative to American National Standards Institute (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; (6) Accept the IAEA transitional requirements and begin the phase- out of packages satisfying the 1967 IAEA requirements, including DOT specification packages; and (7) Require that manufacture of all Type B specification packages conforming to Safety Series No. 6 (1967) 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. Those proposed changes were intended to harmonize requirements of the HMR with international standards for the transport of radioactive materials as well as to promulgate other DOT initiated requirements. More than 150 commenters submitted over 200 comments in response to the NPRM, including representatives of Federal and state agencies, manufacturers, shippers, carriers, consultants, electric utilities, special interest groups, private citizens and trade associations. II. Overview of Changes in This Final Rule A. Summary of Amendments In this final rule, we are amending the HMR 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 A 1 and A 2 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 [[Page 3634]] 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 uranium hexafluoride (UF 6 ); 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 Sec. 173.453 to reflect the NRC ``fissile material exemption provisions,'' to remove the definition of ``fissile material, controlled shipment,'' and to revise Sec.Sec. 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; Prohibit the manufacture of all Type B specification packages conforming to Safety Series No. 6 (1967) as of the effective date of this rule. The use of these packages would be allowed for three 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. In the April 30, 2002 NPRM, we proposed to adopt the nuclide-specific exemption activity concentrations and the nuclide- specific exemption consignment activities listed in TS-R-1. The objective of the proposal was to assure continued consistency between domestic and international regulations for the basic definition of Class 7 radioactive material, i.e., of radioactive material which is deemed hazardous enough to be subject to the HMR. The new exemption activity values would replace the previous activity concentration threshold of 70 becquerels per gram (2000 picocuries per gram)(70 Bq/g (2000 pCi/g)) that has long been used to decide whether a particular radioactive material is regulated by the HMR (i.e., to decide whether it is ``radioactive for the purposes of transport'') the proposed exemption values include. This is in contrast to the previous use of a single threshold defined in terms of an activity concentration. In addition to nuclide-specific activity concentration thresholds proposed, nuclide-specific consignment activity thresholds such that consignments with activities below the latter thresholds would also not be considered ``radioactive for the purposes of transport.'' The considerations which led to the establishment of the exemption values, and the sources from which that information was obtained, are described in the NPRM. They included calculations carried out during the development of TS-R-1, involving 20 radionuclides, which represent radionuclides actually transported, to calculate the activity concentrations and the consignment activities that would not give an annual dose to transport workers of more than 0.01 millisievert (1.0 millirem), or 0.01 mSv (1.0 mrem) during a variety of transportation scenarios. This was done for each of the 20 radionuclides by determining for each of the approximately 24 scenarios (the number of scenarios varied somewhat, depending on the physical form of the radionuclide) the activity concentration and total activity that would yield an annual dose of 0.01 mSv (1.0 mrem), and then selecting the lowest of those activity concentrations and the lowest of those activities as the exemption values for that radionuclide. These activity concentrations and consignment activities were then compared with threshold activity concentrations and threshold activities that had previously been adopted for fixed facilities as a key element in the ``International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources,'' Safety Series No. 115, International Atomic Energy Agency, Vienna, 1996. The IAEA's Standing Advisory Group on the Safe Transport of Radioactive Materials (SAGSTRAM, made up of representatives of a subset of IAEA member countries) had previously agreed that exemption values for transport different from those for fixed facilities would be adopted only if they were different by more than two orders of magnitude, so that to the extent possible, entities dealing with radioactive materials would not have to deal with two different sets of exemption (threshold) values. The IAEA working groups decided to adopt the exemption values previously adopted in Safety Series No. 115 for fixed facilities because the exemption values calculated for the 20 radionuclides using the transport scenarios did not differ by more than two orders of magnitude. This finding was true for all radionuclides (except Kr-85, a noble gas, for which it was argued that because Kr-85 is not transported in such large containers as used in the scenarios, the scenarios used were overly conservative). For those radionuclides in the transport regulations not listed in Safety Series No. 115, transport exemption values were calculated using the Safety Series No. 115 methodology. Using the Safety Series No. 115 exemption activity concentrations and the same transport scenarios, those performing the study calculated the annual worker dose averaged over the 20 previously examined radionuclides to be about 0.23 mSv (23 mrem). This compares with an average annual worker dose of about 0.50 mSv (50 mrem) if the same 20 radionuclides had been transported with an activity concentration of 70 becquerels/gram using the same transport scenarios. In this final rule we are incorporating in the HMR the TS-R-1 nuclide-specific exemption values to specify when radioactive material is regulated as Class 7. According to this new definition, a radioactive material offered for transport is regulated as a Class 7 hazardous material only if both the activity concentration and the consignment activity are greater than the exemption values determined for that material. Discussion. One commenter noted that the nuclide-specific exemption values, which are more closely dose related than a strictly activity- based system, are more defensible. To assist the regulated community in correctly performing these calculations and for consistency another commenter requested that RSPA provide example calculations of the use of the various mixture formulas within the NPRM. To resolve doubts on how to apply the formulas for a specific scenario, any person may obtain help through one of the mechanisms described in Sec. 105.20. One commenter felt that the proposed changes in the exemption activity concentrations, and particularly the proposed default exemption values, do not appear to represent risk- or performance-based approaches and could negatively impact the overall safety of DOE activities. We believe that the proposed changes in the exemption [[Page 3635]] activity concentrations do result in a risk-based approach since the dose equivalent received by a person is much more directly related to the risk than is the activity. Adherence to the criterion of limiting annual worker doses to 0.01 mSv (1.0 mrem) was balanced against the cost and safety implications of having to deal with two sets of exemption values, one for fixed facilities and another for transport. As a result of deciding to use the single set of exemption values derived for fixed facilities, the calculated dose and therefore the risk, was reduced by approximately a factor of two. It is true that the exemption activity concentrations for most of the more commonly occurring alpha emitters have gone down from 70 Bq/g to 10 Bq/g or 1 Bq/g. In several of these cases, such as U(nat), Th(nat), or Ra-226, the number refers to the maximum activity concentration of the parent nuclide in the decay chain (assumed to be in secular equilibrium). Taking into account the activity concentrations of the progeny, the actual activity concentration thresholds for materials with these radionuclides will be higher. With respect to the proposed default exemption values, paragraph 406.1 of IAEA Safety Guide TS-G-1.1 (ST-2), Advisory Material for the IAEA Regulations for the Safe Transport of Radioactive Material, IAEA, Vienna, 2002, indicates that the default values are the lowest possible values within the alpha or beta/gamma subgroups. In the case of the default activity concentration threshold of 1 x 10 - \1\ Bq/g for alpha emitters and for the case when no relevant data are available, the only nuclide in TS-R-1 Table I which has an exemption activity concentration this low is Ac-227. If any person has reason to believe through process knowledge or other means that Ac-227 is not present, or if an upper bound can be placed on the fraction of total activity concentration which may be due to Ac-227, the next lowest alpha emitter exemption activity concentration of 1 x 10\0\ Bq/g be used as the default value. Several commenters recommended that we retain the threshold activity concentration of 70 Bq/g for domestic shipments. One of these commenters argued that the proposed change in the activity concentration exemption values would add significant delays and costs for Department of Energy waste site remediation efforts. The commenter cited past shipments of 98 railcars of soil from the DOE Savannah River Site that were shipped as non-radioactive for purposes of transport because the specific activity of the soil was less than 70 Bq/g, as determined by periodic gross alpha and gross beta measurements. The commenter stated that ``under the proposed regulations, the gross measurements would not provide sufficient confidence in the classification and some isotopic analyses [which would then be required] would require significant time to complete. Performing similar removal actions under the proposed regulations will result in delays and costs for isotopic analysis/confirmation as well as additional costs associated with shipping the material as Class 7. This additional time and expense will be incurred with no significant change in the risk presented by such shipments made in compliance with the current regulations.'' Just as gross alpha and beta measurements may not be sufficient with the new exemption values to determine whether the hazardous materials transport regulations apply, this has also been true in the past when determining whether the activity concentration was below 70 Bq/g. Gross counting measurements cannot yield the activity present until the isotopes and types of radiation, as well as the fractions of the counts caused by each isotope, are known. In cases where one or a few radionuclides are present, this information may be known through ``process knowledge'' or previous measurements, or both. If there are multiple isotopes present it is often not possible to determine this information without doing more lengthy and costly isotopic analyses. In borderline cases, where some batches of a radioactive material have specific activities that exceed the exemption values and others do not, it may be simpler to determine whether any of the material exceeds the LSA-I limits. If not, the material could be treated conservatively and shipped as LSA-I. Although the material would now be transported under the HMR, the existing regulations for domestic shipments of LSA-I contain relatively modest communication and packaging requirements. One commenter supported the proposal to adopt the radionuclide- specific exemption values. The commenter noted that of 2400 intermodal containers of decommissioning soil and debris shipped over a 38 month period, all would have had to be shipped as LSA rather than 10% of them, but that the additional cost would have been minimal. One commenter objected to the nuclide-specific exemption activity concentrations because some of them are higher than the previous 70 Bq/ g value. As pointed out in the NPRM, the hazards associated with radioactive materials are not directly related to their activity or activity concentration, but rather to the dose that a person in the vicinity or in contact with them would receive. The new system would, under the reasonable transport scenarios considered, raise the calculated dose due to some radionuclides from a small value to a somewhat larger, but still small value, while lowering the calculated dose from higher values for other radionuclides. For the 20 representative radionuclides for which detailed calculations were performed, the average calculated annual dose to workers transporting these materials at the proposed exemption activity concentration levels would be reduced from about 0.5 mSv (50 mrem) to about 0.23 mSv (23 mrem), i.e., a reduction in dose of about 50%. Members of the public who were not actually involved in transporting these materials would presumably receive much lower doses, if any. The commenter stated that although the proposed revision cuts the average modeled dose in half, the dose is still much too high. As pointed out above, the decision to use the Safety Series No. 115 exemption values instead of ones calculated specifically for transport, avoided the requirement to use two different sets of exemption values, one for fixed facilities (at least in the countries where these are used, for example most of the European countries) and one for transport. This in itself would likely lead to confusion and more errors, reducing safety. We note that present NRC limits for occupational dose and dose to members of the public due to licensed activities are 50 mSv (5000 mrem) and 1.0 mSv (100 mrem), respectively. This is in addition to background radiation to which we are all exposed. The average background dose to a person living in the United States, according to information in NCRP Report No. 93, ``Ionizing Radiation Exposure of the Population of the United States,'' published by the U. S. National Council on Radiation Protection and Measurements in 1987, is approximately 3.6 mSv (360 mrem), of which about 1.0 mSv (100 mrem) is due to cosmic, terrestrial, and internal sources of naturally occurring radiation; about 2.0 mSv (200 mrem) is due to radon; and the remaining 0.6 mSv (60 mrem) is due mostly to medical procedures, with a small contribution from consumer products and miscellaneous sources. Thus the average modeled dose of 0.23 mSv (23 mrem) for dose to workers due to transport of the 20 radionuclides [[Page 3636]] considered, although not negligible, is small compared to accepted limits and compared to background doses that we all receive. In addition, it is expected that doses from these transport activities to persons not involved in the transport will in almost all cases be much smaller. A commenter suggested that doses from accidents have not been adequately analyzed. The fact that the average dose for the 20 radionuclides considered diminished by a factor of two indicates that on the average, the proposed exemption values should reduce doses due to accidents involving radioactive materials transported at the exemption levels and using the scenarios chosen. This commenter noted that the proposed revision of exemption values would create an inconsistency with the present EPA practice of setting an upper limit of 70 Bq/g on the radioactivity content of waste that can be accepted at a Resource Conservation and Recovery Act (RCRA)- regulated waste disposal site. EPA has indicated that it has no national requirement of this type for RCRA Subtitle C facilities, but that such a requirement is frequently dictated by state regulations for the acceptance of mixed waste, or included in the site permit restrictions. The commenter is correct in implying that the proposed replacement of the 70 Bq/g threshold with the new exemption values, for the purpose of regulating the transport of radioactive materials, may result in some waste being sent to the RCRA site in a radioactive material placarded vehicle. However, where this limit is in use, it was obviously based on DOT's definition of radioactive material. If the intent of using this limit is to avoid having the site receive radioactive waste considered radioactive for purposes of transport, either the state regulations or the permit requirements would have to be changed to accommodate the new exemption values. One commenter supports adoption of the new definition for Class 7 materials. However, the commenter states that the new definition will pose an unreasonable burden to those industries involved in environmental restoration, because classifying low activities in environmental media will be costly and burdensome without benefit. The commenter hopes that RSPA will weigh the effect of each proposed change in light of all affected and adopt domestic exceptions as warranted. As we indicated above, in this final rule we are adopting the TS-R- 1 exemption values to replace the 70 Bq/g criterion for determining when radioactive material will be regulated as a Class 7 hazardous material (with one exception: as discussed under Issue 2, we are also adopting in the HMR the TS-R-1 exception that the Class 7 thresholds will be 10 times the exemption values for ores and other natural materials not intended to be used for their radioactive properties). With respect to this issue and to the others discussed below, we note that we have reviewed the present regulations, the proposed changes, and the various comments we have received, with the objective of achieving a balance between the competing tasks of ensuring safety and of avoiding imposing unjustified economic burdens on shippers and carriers of radioactive materials. In some cases we believe that domestic exceptions are justified, and have, for example, retained the U.S. practice of only requiring that vehicles carrying category Yellow III packages, highway route controlled quantities or exclusive use shipments of LSA/SCO be placarded, as well as the domestic A 2 value of 0.74 TBq (20 Ci) for Mo-99 and A 1 value of 0.1 TBq (2.7 Ci) for Cf-252. Issue 2: Naturally Occurring Radioactive Materials Background. The radioactive material transport regulations are intended to apply to natural materials or ores that form part of the nuclear fuel cycle, or that will be processed in order to utilize their radioactive properties. They do not apply to other natural materials or ores that may contain small amounts of naturally occurring radionuclides, when those materials or ores are to be used because of some other physical or chemical characteristics, provided that their activity concentration does not exceed 10 times the activity concentration in the table in Sec. 173.436. The regulations also do not apply to natural materials and ores containing naturally occurring radionuclides when these have been subjected to physical or chemical processing, when the processing was not for the purpose of extracting radionuclides, again provided that their activity concentration does not exceed 10 times the activity concentration in the table in Sec. 173.436. Examples of such materials are cement, coal, fertilizers, non- radioactive metals, gypsum, residues from mining and smelting processes, etc. In general these materials present a very low radiological hazard. On the other hand there are ores in nature where the activity concentration is much higher than the exemption values. The factor of 10 times the regulatory exemption activity concentration values was chosen as providing an appropriate balance between radiological protection concerns and the practical inconvenience of regulating large quantities of material with low activity concentrations of naturally occurring radionuclides. In conjunction with the adoption of the nuclide-specific exemption values, in this final rule we are also incorporating in the HMR an exception for natural materials and ores containing radioactive material, in that natural materials and ores will be regulated as Class 7 hazardous material only if both their activity concentrations and consignment activities are greater than 10 times the corresponding exemption values. Discussion. One commenter supports the higher threshold of 10 times the exemption values for natural materials and ores that contain naturally occurring radioactive material but are mined for their non- radioactive components or properties, and states that without an exemption for low levels of naturally occurring radioactive materials, application of the Sec. 173.436 exemption values to these materials would result in unnecessarily regulating enormous amounts of material not currently regulated, and that regulating these materials would provide no benefit and increase their costs to the general public. However, this commenter also states that the intent of using these materials for their radioactive components should not be a determining factor in the risk analysis when they are transported in their natural state, and adds that for whatever purpose the materials are being transported, they pose the same negligible risk. The commenter states that it is only when the materials have been processed and the radioactive components are removed from their natural state that the radioactive components should be considered, and adds that the tailings from the removal of naturally occurring radioactive materials should be included in this group, as well as naturally occurring radioactive materials that accumulate from the extraction of non-radioactive minerals. Another commenter suggests that DOT and NRC determine if the exemption below 10 times the activity concentration values in the table in Sec. 173.436 would apply to mill tailings and residual radioactivity in soils and debris. Another commenter indicated that the intended use of a material should not be a factor in how the material should be regulated, and that regulations for the transport of radioactive material should be based only on the radiological properties of the material being shipped. [[Page 3637]] Still another commenter urges RSPA to clarify in the preamble to the final rule that the ``10 times'' (``10x'') exemption for ``natural materials and ores'' includes tailings, secondary materials and solid wastes resulting from non-nuclear processing of such ores. This commenter notes that the need for the shipper to determine the intended end-use of ores creates an artificial and difficult to enforce barrier to the transportation of useful materials, particularly since the eventual end-use is not always known at the time of shipment. In addition, the commenter is not aware of any other instance where DOT applies an ``intent'' based test when determining whether a material is hazardous. One commenter recommends that the 10x exemption apply to the domestic transport of unimportant quantities of source material subject to the 10 CFR 40.13 (licensing) exemption provided that the material and ores not be processed for recovery of source material content. Our intention is that use of the exemption between 1 and 10 times the activity concentration values in the table in Sec. 173.436 be allowed for ores containing small amounts of activity when these ores are not intended to be used for their radioactive properties. Although in most cases it will be obvious why a certain ore is being mined, we agree that there may be instances where the ``intended use'' test can be difficult to apply, and that it would be preferable to minimize this burden on the shipper and carrier. We also agree that the intended use of an ore containing low levels of naturally occurring radionuclides does not change the low degree of risk it would present in transport. In determining if an ore or other material satisfies the 10x exemption criterion, one should avoid using an average activity concentration which masks volumes with much higher specific activities. We suggest that a reasonable criterion for applying the 10x exemption is to determine the ``estimated average activity'' of the ore or material as described in section 4.2.3 of NUREG-1608/RSPA Advisory Guidance 97-005 for ``distributed throughout.'' For example, if the material can be divided into 10 or more equal volumes, each no greater than 0.1 m\3\, and the specific activity differences between all pairs of volumes do not vary by more than a factor of 10, then one may average over the specific activities of all the volumes to obtain the estimated average activity, which may then be compared with 10 times the exemption activity concentration obtained from the table in Sec. 173.436. If there are individual differences in the volume specific activities greater than a factor of 10, start with the volume with the maximum specific activity and average that specific activity with the next nine values in order of decreasing magnitude. If this average is no greater than 10 times the activity concentration from the table, the
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