# Hazardous Materials Transportation Regulations; Compatibility with Regulations of the International Atomic Energy Agency > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A95-22773 ## Record - **Collection:** Federal Register - **Document type:** Rule - **Published:** September 28, 1995 - **Citation:** 60 FR 50292 ## Text SUMMARY: This final rule amends the Hazardous Materials Regulations pertaining to the transportation of radioactive materials to harmonize them with those of the International Atomic Energy Agency (IAEA) and, thus, most major nuclear nations of the world. Several substantive changes are made to provide a more uniform degree of safety for various types of shipments, such as requiring offerors and carriers to maintain written radiation protection programs, revisions to the definition and packaging for low specific activity radioactive materials, and requiring use of the International System of Units for the measurement of activity in a package of radioactive material. However, the basic standards for packaging radioactive materials remain unchanged. The intended effect of this rulemaking is to increase the level of safety and facilitate international commerce concerning the transportation of radioactive materials. Elsewhere in todays Federal Register, the Nuclear Regulatory Commission (NRC) has published a corresponding final rule to its transportation regulations found in 10 CFR Part 71. DATES: Effective date. The effective date of these amendments is April 1, 1996. Incorporation by reference date: The incorporation by reference of certain publications listed in this amendment is approved by the Director of the Federal Register as of April 1, 1996. Compliance date. Voluntary compliance with these regulations, as amended herein, is authorized as of November 1, 1995. FOR FURTHER INFORMATION CONTACT: A. Wendell Carriker, Office of Hazardous Materials Technology, (202) 366-4545, or John A. Gale, Office of Hazardous Materials Standards, (202) 366-8553, U.S. Department of Transportation, 400 Seventh Street SW., Washington, DC 20590. SUPPLEMENTARY INFORMATION: I. Background On November 14, 1989, RSPA published a notice of proposed rulemaking (NPRM; Notice No. 89-8; 54 FR 47454) under Docket HM-169A proposing to amend the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) pertaining to the transportation of radioactive materials so that the HMR would be consistent with IAEA Safety Series No. 6, ``Regulations for the Safe Transport of Radioactive Material Revised 1985 and Supplemented 1988'' (IAEA SS6-85). An extension of time to file comments until May 11, 1990, was published in the Federal Register on February 8, 1990 (55 FR 4445). II. Comments Received A total of 56 comments were received, representing the views of Federal and State agencies, power utilities, and offerors and carriers of radioactive materials. All commenters were in general agreement with the NPRM, but expressed concerns on various topics. Several commenters requested that RSPA issue a second NPRM incorporating the knowledge gained from the comments received. RSPA does not agree that a second NPRM is needed or desirable. RSPA believes that the issues addressed in this Docket should not be delayed further and that the merits of comments have been addressed in this final rule, alleviating the need for another NPRM to be issued under Docket HM-169A. RSPA received many comments that were editorial and general in nature and some comments that raised issues beyond the scope of this rulemaking. All of the comments that correctly pointed out editorial errors in the NPRM are adopted. Comments that are beyond the scope of this rulemaking are not adopted, and, generally, have not been discussed in this preamble. Other comments to Notice No. 89-8 are discussed in the applicable parts of Section III and IV of this preamble. III. Discussion of Amendments While this final rule amends extensive portions of the regulations dealing with the transportation of radioactive materials, the majority of the changes are not substantive. Many changes involve the revision of section and paragraph numbers and their references and the incorporation of the International System of Units (SI units) for radiological measurements, where appropriate. In addition, some sections are rewritten to provide clarity without changing their subject matter. Although not all of 49 CFR Part 173, Subpart I, entitled ``Radioactive Materials'', has been amended, it is reissued in its entirety for convenience of the reader. Substantive changes are discussed in the following paragraphs. A. Radiation Protection On January 27, 1987, the Environmental Protection Agency (EPA) published a document entitled, ``Radiation Protection Guidance to Federal Agencies for Occupational Exposure: Recommendations Approved by the President.'' Among its recommendations, EPA specified that no exposure should occur unless an overall benefit is derived from the activity causing the exposure; that radiation doses must be maintained as low as is reasonably achievable (ALARA); that the annual effective dose equivalent be limited to 50 millisieverts (mSv) (5 rem) to the whole body, 150 mSv (15 rem) to lens of the eye, and 500 mSv (50 rem) to any other organ, tissue or extremity of the body; that occupational exposure for individuals under the age of 18 not exceed 1/10 of the values recommended for radiation workers; and that the dose equivalent to an embryo-fetus as a result of the occupational exposure of a woman who has declared herself to be pregnant should not exceed 5 mSv (500 mrem) during the entire gestation period. In establishing the requirements for radiation protection programs in this rule, RSPA believes they are consistent with the intent of the requirements issued by EPA. RSPA views the radiation exposures being received by workers and the general public as offset by beneficial uses of radioactive material. These benefits are not possible without transportation. The required radiation protection program must keep all radiation exposures as low as reasonably achievable (ALARA), which is also a basic requirement of the EPA guidance. The radiation dose limit specified for workers is 50 mSv (5 rem) per year, which is the whole body dose limit specified in the EPA guidance; and similarly workers are not subject to a radiation protection program if the expected annual radiation dose is less than 5 mSv (500 mrem). The radiation dose limit for an embryo-fetus carried by a female worker who has declared her pregnancy is consistent with the EPA requirements. The radiation protection program has elements that involve training workers, maintaining records, and providing certain kinds of information to workers and to RSPA. [[Page 50293]] The EPA guidance provides different limits for organs and parts of the body, which include concerns for radiation doses that may result from radioactive material being deposited in a person's body. RSPA recognizes the existence of these more detailed requirements that typically relate to fixed facilities. However, for purposes of transportation, RSPA believes the whole body radiation dose due to external radiation exposure is the primary concern and adequately represents the potential risk to workers and members of the general public. Therefore, these regulations impose requirements only on the whole body radiation doses received due to exposure to external sources of ionizing radiation. In the NPRM, RSPA proposed to satisfy the 50 mSv (5 rem) per year EPA dose limitation for occupationally exposed workers by establishing a three-tiered radiation protection program based on provisions in the IAEA transportation regulations. In the proposed rule, no special work patterns or monitoring would have been required for workers receiving a dose less than 5 mSv (500 mrem) per year. For doses between 5 mSv (500 mrem) and 15 mSv (1.5 rem) per year, carriers and other persons would have to determine if special work patterns or monitoring were necessary. For expected doses above 15 mSv (1.5 rem) up to 50 mSv (5 rem), individuals would need to be provided radiation dosimetry devices for monitoring doses. Most commenters agreed in principle that radiation protection requirements should be extended to transportation and transportation- related operations, but objected to some of the mandatory provisions. Several commenters were concerned about the ability of offerors and carriers to determine their applicable ``tier''. The Department of Energy (DOE) stated that carriers need criteria to evaluate the three levels. DuPont stated that transport index is the only quantitative information available to carriers in order to determine if a radiation protection program is necessary. The Hazardous Materials Advisory Council (HMAC) stated that, in making an initial assessment of exposure to determine the appropriate tier of control, a carrier has only a single piece of information to work from: the transport index (TI). HMAC went on to say that DOT should offer specific implementing guidelines on developing a radiation protection program. Other commenters stated that specific guidelines should be issued in order for offerors and carriers to develop a radiation protection program. On the basis of the data submitted to the docket, RSPA concurs with those commenters who stated that the three-tiered approach for determining the scope of a radiation protection program is too difficult and costly for most offerors and carriers to implement. RSPA also concurs with those commenters that stated that TI is the best data available to offerors and carriers in order to determine if a radiation protection program is necessary. Therefore, RSPA is replacing the three-tier approach with a radiation protection program based on the total TI that is handled by an offeror or carrier during a period of one year. A radioactive materials transportation activity involving handling packages with TI's totaling 200 or more in a period of one year is established as a threshold condition which would require a hazardous materials (hazmat) employer to implement a radiation protection program. Persons are excepted from the requirements of establishing a radiation protection program if they handle less than 200 TI in any 12-month period. Therefore, persons who offer or accept only WHITE-I or limited quantity radioactive material packages are excepted from the radiation protection program requirements. Another exception for not establishing a radiation protection program is established for offeror and carriers who handle more than 200 TI per year. This exception involves having a qualified radiation protection specialist to evaluate the doses that workers might receive during a period of one year while handling radioactive materials during transportation. If the evaluation shows that no worker would be expected to receive a dose of 5 mSv (500 mrem) in one year, then a radiation protection program is not required. If an offeror or carrier of radioactive materials is excepted from establishing a radiation protection program, they must maintain certain records and make them available to RSPA or other authorized officials upon request. The records must show that either the total TI of packages transported in any 12-month period is less than 200, or that the current radioactive materials transport activities are the same as the activities that were reviewed by a competent radiation protection specialist whose evaluation demonstrated that no worker will receive a dose exceeding 5 mSv (500 mrem) in one year and that radiation doses to members of the general public are acceptably low. The 200-TI threshold for relief from the radiation protection program requirements is based on findings in NUREG/CR-2200, ``Radiation Exposure of Transportation Workers Handling Large Quantities of Radioactive Packages.'' This study determined that the highest exposure from transporting radioactive materials was from handling of the packages, and found that the average exposure index (i.e., the collective dose to workers per total TI) for handling packages was about 0.45 person mrem/TI. This value is supported by findings presented in NUREG-0154, ``Exposure of Airport Workers to Radiation From Shipments of Radioactive Materials''. This value is also supported by data on file from holders of exemptions E-10045 and E-8308. Using the value of 0.45 (person mrem/TI) for those activities involving an annual TI of 200 or less, annual radiation doses should not exceed the recommended levels for members of the general public. Offerors and carriers subject to the radiation protection program are required to develop and implement a written radiation protection program that prohibits a person from receiving an occupational exposure (dose) of 12.5 mSv (1.25 rem) in any 3-month period or 50 mSv (5 rem) in any 12-month period. To document that no person has received such a dose, all occupationally exposed hazmat employees are required to be monitored by radiation dosimetry devices such as film badges. In conjunction with hazardous materials safety training requirements of Sec. 172.704, hazmat employers of occupationally exposed hazmat employees must implement procedures to reduce the exposures of hazmat employees to ionizing radiation to levels that are as low as reasonably achievable (ALARA). In addition, radiation protection programs must be developed and implemented in accordance with the EPA guidance. In order to provide offerors and carriers with the flexibility to tailor a radiation protection program to their specific operations, and because no set of guidelines could accommodate all of the possible activities that are involved in the transportation of radioactive materials, RSPA refrains from imposing a specific set of guidelines on developing a radiation protection program. RSPA understands the complexities involved in developing and instituting a radiation protection program and is delaying compliance with these requirements until October 1, 1997. Several commenters claimed that a radiation protection program based on the ALARA principles would be ``too subjective'' and would be difficult both to apply and to enforce and, thus, [[Page 50294]] should not be adopted as a mandatory requirement in the HMR. RSPA acknowledges the difficulties of enforcing a radiation protection program that is based on the principles of ALARA. However, the EPA guidance, and the radiation programs requirements of the NRC and the Occupational Safety and Health Administration are based on ALARA principles. The principle of reduction of exposure to levels that are ALARA is typically implemented in two different ways. First, it is applied to the design of the facility so as to reduce, prospectively, the anticipated exposure of workers. Second, it is applied to actual operations; that is work practices are designed and carried out to reduce the exposure of workers. Effective implementation of the ALARA principles involves: education of workers concerning the health risks of exposure to radiation; training in regulatory requirements and procedures to control exposure levels and doses; and management and supervision of radiation protection activities, including the choice and implementation of radiation control measures. RSPA believes that adoption of the ALARA principles as a requirement in the HMR is an important facet of a radiation protection program, and, therefore, is not adopting these commenters request to adopt the ALARA principles as a non-mandatory requirement. As noted above, radiation protection programs must be developed and implemented in accordance with the EPA guidance. In order to make it easier for the regulated community to comply with the radiation protection program requirements, RSPA has extracted from the EPA guidance and placed in the HMR some of the more important aspects of the EPA guidance. These include the limits on exposure to pregnant females and persons under the age of 18, and recordkeeping requirements. Though RSPA is not imposing a specific set of guidelines to be followed in developing a radiation protection program, RSPA is referencing two reports from the National Council on Radiation Protection and Measurements (NCRP) which provide useful information in developing and implementing a radiation protection program. NCRP Report No. 116, titled ``Limitation of Exposure to Ionizing Radiation'', addresses limits for workers as well as for members of the general public. That report is essentially consistent with the most recent guidance from the International Commission on Radiological Protection (ICRP) which is also being incorporated into the basic radiation protection standards of the IAEA. In NCRP Report No. 116 the annual radiation dose limit for workers is essentially 20 mSv (2 rem) and the limit for members of the general public is 1 mSv (100 mrem) per year. The report contains many of the requirements in the 1987 EPA Guidance, and 10 CFR Part 20. The recommendations in NCRP Report No. 116 cover existing and probable future radiation dose limits and practices for regulating the radiation doses. The other NCRP Report, No. 59 ``Operational Radiation Safety Program'' (1978) is recommended as guidance to be tailored to the needs of a hazmat employer when a radiation protection program needs to be established. The report contains information about organization, activities, emergency planning, equipment, reporting and documentation, facilities, training, personnel qualifications, etc. The information is useful for developing radiation protection programs for small and large corporations. In this final rule, the radiation dose limit for members of the general public is the same as those proposed in the NPRM, (i.e., 5 mSv (500 mrem)) per year. This value is consistent with the Federal Radiation Council (FRC) guidance of 1960 and was consistent with the NRC's 10 CFR Part 20 in 1989. Subsequently, NRC revised 10 CFR Part 20 and their annual limit for exposures to members of the general public is now 1 mSv (100 mrem) per year. EPA is currently developing guidance for regulatory agencies for limiting radiation exposures for members of the general public, and the anticipated annual limit is expected to be 1 mSv (100 mrem) with no single practice or activity causing a person to receive more than a minor fraction of that limit. In a future rulemaking, RSPA will address the new guidance from EPA concerning exposures of the general public. A number of commenters questioned the relationship between radiation exposure limits proposed in the NPRM and the minimum separation distances required in the HMR. The DOE noted that, if changes are not made, the occupational dose limits proposed in Sec. 173.405 would be quickly exceeded as a result of the modal requirements in Parts 174-177. RSPA acknowledges the differences between the dose limits established in the radiation protection programs and the dose rate limits related to TI separation distances set forth in Parts 174, 175, 176, and 177. However, RSPA believes that requirements addressing both annual dose limits and TI/separation distances are essential in establishing effective radiation protection standards. Minimization of annual doses received by occupationally exposed workers and members of the general public is the primary objective in any adequate radiation protection program. Although TI/ separation distance requirements do not, in themselves, assure that annual dose requirements will be met, they comprise minimal operational requirements that must also be satisfied. A carrier may have to impose more restrictive limits in its radiation protection program. A number of commenters asked if radiation protection requirements apply only to workers preparing the material for shipment, to workers receiving packages, or to carriers during transport. This confusion arose because the radiation protection program requirements were proposed to be adopted in Part 173. Accordingly, RSPA is clarifying the applicability of the requirements for the radiation protection program by moving the requirements to subpart I in Part 172 in order to clarify that the requirements apply to both offerors and carriers of radioactive materials. In addition, applicable sections have been added to the modal parts in Parts 174, 175, 176 and 177, in order to ensure that carriers are aware of the radiation protection requirements in subpart I of part 172. RSPA agrees with a number of commenters that provisions established in this final rule should not replace or duplicate existing approved radiation protection program requirements. Accordingly, RSPA is adding an exception which states that any radiation protection program already in place and approved by an appropriate federal or state agency is deemed adequate to meet the radiation protection requirements of the HMR. Many commenters were concerned about the definitions of several terms, particularly ``transport worker'' and ``general public''. The phrase ``transport worker'' is being replaced by the phrase ``hazmat employee'', which was defined in Sec. 171.8 as a result of Docket HM- 126F. In the context of radiation protection programs, this term is further refined to include only ``occupationally exposed hazmat employees.'' In this final rule, the term ``general public'' is defined in Sec. 171.8 to include persons other than occupationally exposed hazmat employees. Several comments compared the requirement to provide training as to the hazards of radioactive materials and the provisions in Part 172, Subpart H to provide safety training to all hazmat employees. As specified in Part 172, [[Page 50295]] subpart H, hazmat employees must receive safety training in all classes of hazardous materials with which they work; therefore, the requirement proposed in Sec. 173.405(c) to train persons as to the hazards of radioactive materials is no longer necessary and is not adopted in this final rule. B. Low Specific Activity Material and Surface Contaminated Objects Based on the provisions contained in IAEA SS6-85, RSPA proposed to revise comprehensively the regulations for the shipment of low specific activity (LSA) radioactive material. A new designation for radioactive material called surface contaminated object (SCO) was also proposed. Unlike LSA, which requires a uniform distribution of radioactive material within the material; materials classified as SCO are not inherently radioactive, rather they are objects with radioactive contamination on their surfaces. The proposals for LSA and SCO consisted of the following: 1. An expansion of the LSA definition to include new types of material; 2. A new definition of ``surface contaminated object'' (SCO) that is treated in a manner similar to LSA material; and 3. An increase of specific activity limits for nondispersible, nonrespirable forms of LSA material while at the same time limiting the quantity of LSA material that can be shipped in other than a Type B package to 2 times the A1 value (2A1) for the specific nuclide being transported. A new type of package, called the ``industrial package'', was also proposed for the handling of LSA and surface contaminated objects (SCO). Three categories of industrial packages (IP), IP-1, IP-2 and IP- 3, were proposed. RSPA proposed to require these packages for the shipment of LSA and SCO instead of currently required packages (i.e., either a modified Type A package or a strong, tight (nonspecification) package. Commenters raised concerns over various aspects of the proposed regulation of LSA materials, including the proposed definitions, potential increases in packaging costs for LSA materials, and the proposed removal of an exclusive use shipment exception in Sec. 173.425(b). Particularly, commenters objected to requiring Type B packages for the shipments of LSA exceeding 2 times the A1 value of the radionuclide. Commenters claimed that the 2A1 limit was not a close approximation of the IAEA limit of 1 rem/h at 3 meters. Commenters claimed that a closer approximation of the IAEA limit is 4 times the A1 value (4A1). Commenters stated that the IAEA limit of 1 rem/h at 3 meters, a limit 4A1, or a combination of the two, should replace the proposed 2A1 limit. One commenter stated that the IAEA limit was impractical and unworkable and favored adoption of a multiple of a A1 approach (i.e., 4A1). However, the Department of Energy stated that the IAEA approach is very practical and that it has been implemented internationally. Another commenter stated that industry can implement the IAEA limit of 1 rem/h at 3 meters and requested that RSPA replace the 2A1 limit with the IAEA limit. The IAEA added the limit of 10 mSv/hour (1 rem/hour) at 3 meters for the radiation level from the unshielded contents of LSA and SCO packages not designed to withstand accidents. This radiation level limit controls the external radiation exposures to individuals if an LSA package is severely damaged in a transportation accident. The IAEA limit considers the loss of package shielding during an accident, but it does not consider the possibility that a package's contents might be released and redistributed, causing a reduction in self-shielding of the contents. The reduction in self-shielding could result in potential accident radiation levels that significantly exceed IAEA's 10 mSv/hour (1 rem /hour) at 3 meters limit. The IAEA dose rate limit provides a significant added degree of protection over the 1973 IAEA regulations (which specify no quantity limit for LSA packages). RSPA and NRC did not believe, however that the IAEA limit provided the same level of safety for all types of LSA material, particularly for relatively large quantities of radioactive materials contained in dispersible LSA materials (e.g., resins and other media used in liquid radioactive waste treatment). In lieu of the radiation level limit, RSPA and NRC proposed a 2A1 quantity limit for all LSA packages. Although this proposal addressed the accident concern by directly limiting package quantity, it was not compatible with the IAEA provisions. Both agencies received many comments on the proposed 2A1 quantity limit that objected to the impacts on occupational dose and shipping costs. Further, the Advisory Committee on Reactor Safeguards (ACRS) issued a letter report, dated December 19, 1994, recommending, inter alia, that the requirements again be reevaluated with the objective of making them equivalent to the IAEA regulations. After consideration of ACRS and industry comments, RSPA and NRC have agreed to adopt the IAEA LSA provisions. Accordingly, the final rule imposes a limit on the external radiation level at 3 meters from the unshielded contents of LSA-I, LSA-II, LSA-III, SCO-1, or SCO-II packages of 10 mSv/hour (1 rem/hour). Numerous comments addressed the proposed removal of the present authorization for use of Type A packages and exclusive use shipments of strong, tight containers for LSA'materials. Commenters stated that LSA materials pose a minor risk to the public and that there is no justifiable safety reason to replace the currently authorized packagings with the industrial packagings. Commenters also cited an increase in the packaging costs for LSA materials without an equivalent increase in public safety if the Type A, and strong, tight packagings were not allowed for transportation of LSA material. Upon further review of the proposal to remove the Type A packaging and the strong, tight packaging as authorized packagings for LSA materials, RSPA has decided to retain these packagings for the transportation of LSA material because the benefits associated with the proposal are not commensurate with the increase in costs. However, industrial packagings are added as an authorized packaging for LSA material and SCO in order to provide the industry greater flexibility and to facilitate international commerce. Several comments addressed the definition of LSA material and SCO. One commenter requested that dewatered material be defined as a solid for LSA-II. LSA-II is expected to include nuclear reactor process wastes, including filter sludge, absorbed liquids, and lower activity resins. RSPA and NRC believe the LSA-II specific activity limit for solids, rather than that for liquids, applies to dewatered resins. Therefore, RSPA and NRC see no need to define dewatered material as a solid for LSA-II. Commenters were also concerned about their ability to measure the contamination on inaccessible surfaces of SCO's. Though it is impossible to directly measure the fixed contamination on an inaccessible surface of an object, it is possible to determine the contamination level on the inaccessible surface through physical measurements and mathematical analysis (involving geometric and attenuation factors) of the object. One commenter compared the new limits for SCO with existing limits for [[Page 50296]] LSA material in Sec. 173.403 and claimed there was a reduction in the specific activity limits in the proposed rule. RSPA notes that the proposed and final rules for shipping SCO-I contain the same limits for fixed radioactive surface contamination as were present in the previous definition of LSA material. The difference in the SCO-I definition is the addition of the normal package limits on removable external contamination. The change from existing regulations is the addition of the definition of SCO-II for solid objects which are more heavily contaminated on their surfaces then SCO-I objects. Some commenters also requested that the definition of LSA-I be expanded to include material generated from the extraction of uranium or thorium. Another commenter recommended that the term ``contaminated soil'' in LSA-I be expanded to include ``soil, earth, concrete rubble and other bulk debris.'' Another commenter expressed concern that mill tailings exceeding 10E-6A2/g could not be shipped in bulk under the proposed rule. The commenter recommended that either mill tailings be specifically included in the definition of LSA-I without an activity or concentration limit, or the specific activity limit for LSA-I be increased to 4x10E-6A2/g. RSPA agrees that ore-like materials (materials with highly uniform distribution of small quantities of radionuclides) should be transported as LSA-I material. Accordingly, the definition of LSA-I is expanded from ``contaminated soil'' to ``contaminated soil, mill tailings, concrete rubble and other debris * * * '' RSPA believes that mill tailings will meet the proposed 10E-6A2/g specific activity limit, and therefore, has not increased the limit. For clarity, the proposals contained in Secs. 173.411 and 173.414 have been combined into Sec. 173.411. In Sec. 173.427, reference to IP packagings is followed by a parenthetic reference to Sec. 173.411 to show where the requirements for industrial packagings are found. One commenter requested that the record keeping requirements for IP packagings not apply to IP-1's. RSPA concurs and has revised the final rule accordingly. Some commenters requested that an IP packaging be required to be marked in order to identify that the packaging does meet the appropriate packaging standard. Though RSPA agrees with the commenter's point, RSPA did not propose a marking requirement and, therefore, considers this recommendation outside the scope of the rulemaking. However, RSPA may propose such a requirement in a future rulemaking. C. International System of Units (SI) In the NPRM, RSPA proposed that the activity of a package of radioactive materials be described in SI units (i.e., becquerels), consistent with IAEA SS6-85, in lieu of the customary units of curies. Several commenters requested that the use of SI units on shipping papers and labels be required for international shipments only, with domestic shipments using customary units as the standard. The basis of this request appears to be for ease of training of transport workers, emergency responders, and personnel in industry and local governments. It was also noted that most emergency response radiation detection instruments specify readings in customary units only. U.S. policies and procedures for conversion to the metric system were formalized by the Metric Conversion Act of 1975 (Pub. L. 94-168, 15 U.S.C. 205a). The Act declared that U.S. policy shall be to coordinate and plan the increased use of the metric system. From a safety standpoint, the need for consistency in radioactive materials package identification is critical. All parties potentially having contact with the package must be able to understand the units used in order to establish proper controls. It is recognized that the U.S. conversion to metric units may create special problems since, in order to succeed without jeopardizing safety, the new units must be used, or at least understood, universally. It is also recognized that the use of SI units for radioactive material has proceeded internationally. IAEA SS6-85 allows the use of both units with SI units controlling. The International Civil Aviation Organization's Technical Instructions and the International Maritime Dangerous Goods Code (IMDG Code) have required the use of the SI units for several years. The fact that international shipments use SI units could give rise to safety concerns if the U.S. fails to accommodate SI units to or from countries using the internationally accepted units. RSPA recognizes the additional training required by this change; however, the safety benefits exceed the costs and it is necessary to proceed with the change to SI units. However, for domestic shipments, shipping papers and labels may be allowed to contain either SI units or the combination of SI and customary units. In addition, RSPA is delaying mandatory compliance with this requirement until April 1, 1997. Several commenters were also concerned about the inconsistencies between RSPA and NRC proposed rules with regard to units of measurement. RSPA proposed regulatory requirements using SI units followed by customary units in parenthesis. NRC proposed the reverse order. NRC, in its final rule, agreed with RSPA that SI units must be stated first. D. Expansion of Radionuclide List and Changes in Radionuclide Limits The table in Sec. 173.435, which provides A1 and A2 values, has been expanded by nearly 100 entries to include all radionuclides that have the potential to be transported. Because there now should be few instances where unlisted radionuclides would be transported, the rules for calculating values for unlisted radionuclides have been simplified. However, the determination of limits for unlisted radionuclides, except in a few cases, is subject to RSPA approval. IAEA SS6-85 modified the system for determining A2 and A2 values. Although this system is based on achieving essentially the same limitations on potential radiological accident hazards as the previous system, the new system has the following advantages: 1. It states more clearly the radiation protection criteria employed; 2. It incorporates the data and conclusions on metabolic pathways provided during the years 1977-1981 by the International Commission on Radiological Protection (ICRP); 3. It includes dosimetric routes through human organs not previously considered; and 4. It harmonizes IAEA SS6-85 with ICRP recommendations on radiological safety in Publications ICRP-26 and ICRP-30. The effect of the adoption in IAEA SS6-85 of this new system for calculating A1 and A2 values, and the subsequent incorporation of the new values in the HMR, is that most current A1 and A2 values have been amended. Of the 284 radionuclide entries in Sec. 173.435, A2 values have been raised in 129 cases and lowered in 95 cases. Of the A1 values, 144 have been raised and 73 lowered. Several commenters objected to the proposal to lower the A2 value for molybdenum-99 from 0.8 TBq (20 curies) to 0.5 TBq (13.5 curies). Commenters stated that shipments of Mo-99\Tc-99m generators to hospitals would increase significantly in order to comply with this lower limit. Instead of being able to ship 0.6 TBq (16 curies) in one generator, manufacturers would have to ship two different generators which would increase their costs and the costs to the hospital. In addition, the commenters contended, these additional shipments would increase the level of radiation exposure for those workers [[Page 50297]] who handle the generators. The commenters also cited the excellent safety record in transportation of these generators, and requested that a domestic exception be provided to allow these generators, that are DOT Specification 7A Type A packagings, to contain as much as 0.8 TBq 20 curies of molybdenum-99. Upon further review of this proposal and of the data received from the commenters, RSPA has decided to allow a domestic exception for molybdenum-99. A footnote has been added to the Sec. 173.435 Table of A1 and A2 values which authorizes, for domestic use only, the use of DOT Specification 7A Type A packagings for molybdenum-99 up to 0.8 TBq (20 curies). One commenter objected to the lowering of the A2 values for carbon-14, phosphorus-32, sulfur-35 and iodine-125. The commenter was concerned that these lower values would require Type A packagings for these materials, instead of the excepted packagings that are currently authorized. However, the commenter did not provide sufficient data to support these concerns and, therefore, this commenter's request has not been adopted. The new IAEA system for calculating A1 and A2 values is further described in Appendix I, ``The Q System for the Calculation of A1 and A2 Values,'' of IAEA Safety Series No. 7, ``Explanatory Material for the IAEA Regulations for the Safe Transport of Radioactive Material (1985 Edition).'' A copy of this document is available in RSPA's Docket Unit for review by interested parties. E. Classification of Fissile Material As a result of the evolution of the fissile material criteria, IAEA recognized that the three fissile classes could be combined and simplified into a single system. The effects of the simplification of the IAEA system now being adopted into the HMR are the: 1. Elimination of the three fissile class designations; 2. Establishment of a single set of criteria for all packages of fissile materials; and 3. Use of the TI as the primary control of accumulations of packages in transportation under nearly all conditions. F. General Design Requirements for All Packagings All packagings of radioactive materials, including excepted packages, are required to meet general design requirements prescribed in Sec. 173.410. These packagings must be designed for ease of handling and proper restraint during shipment. They must be free of protuberances, easily decontaminated, capable of withstanding the effects of vibration during transport, and also meet reduced pressure and temperature requirements. Minimum design requirements for excepted packagings will increase the overall integrity of the packages. Further discussion of Sec. 173.410 can be found in the Review-by-Section portion of this preamble. G. Docket No. HM-181 On December 21, 1990, RSPA published a final rule under Docket No. HM-181 entitled ``Performance-Oriented Packaging Standards: Changes to Classification, Hazard Communication, Packaging and Handling Requirements Based On UN Standards and Agency Initiative'' (55 FR 52402). That final rule comprehensively revised the HMR with respect to hazard communication and packaging standards. In addition, Docket No. HM-181 adopted some of the proposals in the NPRM under docket HM-169A. Those proposals adopted under Docket HM-181 include the reference to the 1985 edition of IAEA Safety Series No. 6, and its 1988 Supplement, and most of the proper shipping names. For additional discussion on the various supplements to IAEA SS6-85 see the discussion of Sec. 171.7 in the Review-By-Section portion of this preamble. H. Editorial Changes This final rule makes several editorial changes to the HMR. References to the ``Director, OHMT'' are revised to read ``Associate Administrator, Office of Hazardous Materials Safety''. The term ``radioactive material'' is revised to read ``radioactive materials'' in conjunction with the amendments under Docket No. HM-181. Section 173.411, entitled ``General design requirements'', has been redesignated as Sec. 173.410. Section 173.421-1 through 173.427 are redesignated as Secs. 173.422 through 173.428. Corresponding changes have been made to the HMR to other sections which reference the redesignated sections. In the following discussion, section references are to the new section numbers, therefore, RSPA is providing the following redesignation table to assist the reader: ------------------------------------------------------------------------ New section Old section No. No. ------------------------------------------------------------------------ Sec. 173.411.............................................. Sec. 173.4 10 Sec. 173.421-1............................................ Sec. 173.4 22 Sec. 173.421-2............................................ Sec. 173.4 23 Sec. 173.422.............................................. Sec. 173.4 24 Sec. 173.423.............................................. Sec. 173.4 25 Sec. 173.424.............................................. Sec. 173.4 26 Sec. 173.425.............................................. Sec. 173.4 27 Sec. 173.427.............................................. Sec. 173.4 28 ------------------------------------------------------------------------ IV. Review-by-Section Section 171.7. As proposed, several references to documents have been added and revised in this final rule. It was brought to RSPA's attention that some foreign countries have adopted IAEA SS6-85 or one or more of its supplements (i.e., Supplement 1986, 1988 and the As Amended 1990 edition). Because the changes in these supplements were not substantive in nature, RSPA is allowing the export or importation of radioactive materials in accordance with any of the supplements to the 1985 Edition of IAEA Safety Series No. 6. Section 171.8. This section is amended by adding definitions for ``General public'' and ``Occupationally exposed hazmat employee''. For additional discussion of these terms and how they relate to radiation protection plans, see section III of this preamble. Section 171.10. This section is amended to incorporate SI units for radioactive materials. RSPA proposed to add Sec. 173.402 which would have repeated the requirements of Sec. 171.10. Because this would have been repetitive, RSPA is not adopting proposed Sec. 173.402 but is amending Sec. 171.10. Section 171.10 is amended to phase in the SI units for radiological measurements. The HMR uses SI units followed by the customary units in parentheses. In many cases the limits in customary units are extended to 3 significant figures so they represent a functional equivalent to the limits expressed in SI units. The objective of this approach is to achieve consistency with international regulations while allowing U.S. shippers to use the units with which they are most familiar. Section 171.11. This section is amended to clarify that the provisions of Secs. 172.204(c)(4), 173.448(e)(f) and (g)(3) do not apply to limited quantity shipments transported under the provisions of the International Civil Aviation Organization's Technical Instructions for the Transport of Dangerous Goods (ICAO TI). Section 171.12. This section is editorially revised to reference the correct edition of IAEA Safety Series No. 6 and to clarify that shipments of radioactive materials transported in accordance with IAEA SS6-85 must comply with the emergency response requirements of subpart G of part 172. Section 172.101. Most of the proposals in the NPRM to amend the [[Page 50298]] Sec. 172.101 Table were adopted under Docket No. HM-181. However, several editorial changes are being made to the table to address section number changes (e.g., Sec. 173.421-1 redesignation as Sec. 173.422). Section 172.203. This section is revised to add references to SI units, replace references to Fissile Class III with ``Fissile material, controlled shipments'' and to require appropriate group notations for LSA and SCO material on shipping papers. In addition, mass information is allowed to replace activity information for uranium fissile radionuclides. For plutonium fissile radionuclides mass information may be included with the activity information on shipping papers. Also, Sec. 172.203(d)(10) is added to require that the phrase ``Exclusive Use Shipment'' be added to shipping descriptions for shipments that are transported under provisions for exclusive use shipments. This statement may appear in any visible location on the shipping paper when the entire shipment is consigned as exclusive use. However, this statement does not relieve a offeror from providing exclusive use shipment controls to the carrier as required by Secs. 173.403 and 173.427. Several commenters to this section objected to requiring the statement ``Fissile Material'' to appear with shipping descriptions for fissile materials because their proper shipping name contains the words ``Radioactive material, fissile, * * * '' RSPA concurs with these commenters and has not adopted this proposal. Another commenter opposed the requirement in Sec. 172.203(d)(1) to list all radionuclides on shipping papers. RSPA recognizes that it is sometimes impractical to identify all radionuclides contained in a package of some radioactive materials. Therefore, in this final rule, RSPA is amending Sec. 172.203(d)(1) to require that the shipping paper identify the most hazardous radionuclides only. These nuclides are determined in accordance with the restriction of activity for A1 and A2 values described in Sec. 173.433(f) that specifies, through use of a formula, that those radionuclides that represent 95% of the hazard shall be listed. Section 172.310. This section is amended to require the trefoil symbol, as specified in new Appendix B to Part 172, be marked on Type B, Type B(U), and Type B(M) packages of radioactive material in a plain and durable fashion. One commenter objected to this requirement on the basis that the package would already display the trefoil on the radioactive material label. However, a label does not meet the requirement of being durable. Therefore, this amendment is adopted as proposed. Section 172.403. This section is amended to add a reference to SI units. One commenter was concerned over the proposal to allow mass information in place of activity information on labels of fissile material packages. The commenter stated that RSPA should not adopt this proposal because such information would provide insufficient information to radiological emergency response forces in the event of an incident. RSPA agrees with the commenter as it pertains to plutonium radionuclides, but believes that mass information for uranium radionuclides provides sufficient information to emergency responders. Therefore, RSPA is modifying Sec. 172.403 to authorize the substitution of mass information for uranium fissile radionuclides, and the addition of mass information to the activity information for plutonium fissile radionuclides. Section 172.407. This section is revised by adding paragraph (g) to note where the radioactive trefoil specification is located in the HMR. Section 172.504. This section is amended by revising the footnote in Table 1 to reference the new section for LSA material and to add reference to SCO. Section 172.507. This section is editorially revised by correcting section references and terminology (i.e., Class 7 rather than radioactive material). Sections 172.801-172.807. These sections are added to new subpart I of part 172, to implement a requirement for the establishment of radiation protection programs in accordance with EPA's ``Radiation Protection Guidance to Federal Agencies for Occupational Exposure'' and the IAEA SS6-85. For further discussion of these requirements, see the discussion in section III.A of this preamble. Appendix B to part 172. Appendix B to Part 172 is added to note size requirements for the trefoil symbol on package markings, labels, and placards. Several commenters noted an error in the proposed size requirements that is corrected in this final rule. Sections 173.2a and 173.4. These sections are revised to correct section references. Section 173.403. This section is amended by adding new definitions for: ``Class 7 material,'' ``Surface contaminated object (SCO)'', ``IP packagings'', and, ``Low toxicity alpha emitters''. The definitions for ``Fissile material'' is revised to specify listed radionuclides, and the reference to Sec. 173.455 is removed. The definition of Low specific activity (LSA) material is revised to conform to the IAEA definition. Many commenters requested an expansion of the definition of ``Package-excepted package'' to include Sec. 173.426, articles containing natural uranium and thorium. RSPA agrees with the commenters and is adding that reference. Several commenters requested that the definition of ``Type A package'' be revised to specify that these packages do not need Competent Authority approval. RSPA agrees, and the definition is so revised. One commenter requested that the definition of ``transport index'' include the commonly used term ``TI''. RSPA has also incorporated this request. Proposed Section 173.404. This section was proposed to specify the U.S. Competent Authority for the transport of radioactive materials. Because this term is currently defined in Sec. 171.8, thus making proposed Sec. 173.404 repetitive, this proposal has not been adopted. Section 173.410. This section, entitled ``General design requirements'', was previously found in Sec. 173.411. It is amended as follows: --A package has to be capable of withstanding the effects of acceleration, vibration or vibration resonance during transport; --The materials of the packaging and any components must be chemically and physically compatible; --All valves through which the package contents could escape must be protected; and --A package intended for air transport has to be designed to withstand reduced temperature and pressure during transport. Several commenters objected to the proposal to require that excepted packages have a minimum dimension of 10 cm. (4 inches). The commenters stated that IAEA regulations subject only Type A packagings only to the 10 cm. minimum dimension requirement. RSPA agrees with these commenters and has moved the 10 cm. minimum dimension requirement to Sec. 173.412; therefore, excepted packages are not required to have a minimum dimension of 10 cm. (4 inches). Section 173.411. See section III.B and the discussion of Sec. 173.412 in this preamble for discussion of the changes to this section. Section 173.412. This section, entitled ``Additional design requirements for Type A packages,'' is amended to permit all packages containing liquids to use a double containment system. This eliminates the previous small package prohibition of this practice as well as requiring that expansion of liquids during temperature changes be [[Page 50299]] considered during design. This section is amended to include a closure requirement on a containment system that is a separate unit of the packaging. One commenter requested that the phrase ``significant increase'' be revised to read ``20% increase'', which would be in conformance with IAEA. RSPA believes that the term ``significant'' is necessary to handle the different packaging parameters, and therefore, is not adopting this commenter's request. Section 173.413. This section is editorially revised to correct section references and terminology. Section 173.415. This section, ``Authorized Type A packages'', is amended to eliminate the reference to DOT Specification 55 packaging, which has not been authorized since July 1, 1985. This section is also amended to permit the use of Type A packagings that meet the NRC fissile material packaging requirements. Section 173.416. This section, ``Authorized Type B packages,'' is amended to eliminate the reference to the DOT Specification 55 packaging, and eliminate the use of DOT Specification 55 packaging as an inner container for DOT Specification 20WC and 21WC overpacks. Section 173.417. This section, ``Authorized packages--fissile materials,'' is amended to eliminate references to different fissile classes and to remove a direct reference to authorized packaging for 500 grams of Uranium-235 and 320 grams of plutonium. Section 173.417(a)(8) and (b)(5) specify the authorized packagings for Type A and Type B, respectively, quantities of uranium hexafluoride (UF6). Section 173.417(b)(5)(iii) limits the amount of uranium hexafluoride in a package to the amount specified in ``Table 6-- Authorized Quantities Of Uranium Hexafluoride (UF6).'' In Table 6, however, only DOT specifications 20PF-1 and 20PF-2 are authorized to contain a Type B quantity of uranium hexafluoride. Therefore, Sec. 173.417(b)(5) is revised to authorize only the DOT specifications 20PF-1 and 20PF-2 for the transportation of Type B quantities of uranium hexafluoride. In addition, because their use is no longer allowed, the Specification DOT 21PF-1 overpack has been removed from Sec. 173.417(a)(8)(ii). Sections 173.418-173.420. These sections are revised to correct section references and terminology. In addition, this section is revised, consistent with the changes in Sec. 173.423, to note that limited quantities of radioactive material that meet the definition of a hazardous substance or hazardous waste must comply with the shipping paper requirements of the HMR. Section 173.421. This section, ``Excepted packages for limited quantities of radioactive material,'' is amended to require compliance with the design requirements of Sec. 173.410. Section 173.422. The proposal in this section, ``Additional requirements for excepted packages,'' to incorporate new proper shipping names and new UN identification numbers for excepted packages, was adopted under Docket HM-181. Therefore, no changes are made in this final rule. Section 173.423. This section is revised to correct section references and terminology. This section is also revised based on changes from Docket HM-181 and to correct terminology. Since a material that meets the definition of Class 7 it cannot, by definition, meet the definition of Class 9, reference to Class 9 are removed and appropriate changes have been made to Sec. 173.421 (i.e., shipping papers are required). In addition, RSPA believes that specific references to Combustible liquids are no longer needed with the changes to Sec. 173.421, therefore, the provisions previously found in paragraph (b) have been removed. Section 173.424. The NPRM proposed amending this section, ``Excepted packages for instruments and articles,'' to require that instruments and articles be marked with the word ``radioactive.'' Several commenters objected to this proposal. The commenters indicated that devices containing radioactive materials in small quantities require approval by the NRC, who does not require the ``Radioactive'' marking. They expressed concern that the marking may cause a disproportionate public alarm for a very small quantity of radioactive material. Commenters from the lighting industry also were concerned that the ``Radioactive'' marking may discourage the use of energy efficient lighting products. Upon review of the proposed requirement, and contrasting the cost to the manufacturer and the possible effect on NRC exempt-distribution licensees versus the increase in safety that the marking may provide, RSPA is not to adopting this proposal. RSPA notes, however, that such instruments and articles must be so marked if transported in accordance with the ICAO Technical Instructions, IAEA Safety Series No. 6, or the IMDG Code. Section 173.425. As proposed, this section, ``Table of activity limits--excepted quantities and articles,'' would have removed the direct reference to tritiated water. Several commenters requested that these limits be retained for domestic use only. Because of the relatively low hazards associated with tritiated water, RSPA concurs with these commenters and has not removed these limits. Sections 173.426-173.431. See the ``Background'' section of the preamble for discussion of the changes to these sections. Section 173.433. This section, ``Requirements for determination of A1 and A2 values for radionuclides,'' is completely amended to incorporate a less complex method for calculating the A1 and A2 values. Section 173.434. This section is revised to add references to SI units. Section 173.435. This section, ``Table for A1 and A2 values for radionuclides,'' is amended to incorporate new A1 and A2 values as specified in the IAEA regulations. Section 173.441. Several commenters to this section, ``Radiation level limitations,'' requested that the limits specified be applied only to the ``accessible'' surface of the package. RSPA believes that this issue warrants further public discussion and, therefore, it is beyond the scope of this rulemaking. RSPA will consider proposing a change consistent with this request in future rulemaking. Section 173.442-173.446. These sections are revised to correct section references and terminology. Section 173.447. This section, ``Storage incident to transportation--general requirements,'' is amended to delete references to fissile classes. Additionally, two commenters requested that this section be eliminated, based on the idea that if a larger number of packages were permitted to be stored together, rather than segregated by the sum of the transport indices, the packages would shield each other and thus reduce the total potential exposure. RSPA believes that this issue is beyond the scope of this rulemaking. Section 173.448. This section, ``General transportation requirements,'' is amended to delete references to fissile classes. Section 173.451. See the ``Background'' section of the preamble for a discussion of the changes to this section. Section 173.453. This section, ``Fissile materials--exceptions,'' is amended by deleting the exception for thermal reactor irradiated uranium and thorium or uranium with not more than 0.72% fissile material. One commenter pointed out that the higher limit of 800 grams of fissile mass should apply to uranium-235 only. RSPA concurs and has modified this section accordingly. [[Page 50300]] Section 173.455. This section, ``Classification of fissile materials packages,'' is deleted entirely because of the elimination of fissile classes. Section 173.457. This section, ``Transportation of fissile material- controlled shipment--requirements,'' redefines fissile class III shipments in terms of a ``fissile material, controlled shipment.'' Section 173.459. This section, ``Mixing of fissile materials packages,'' is amended to delete references to fissile classes and to express shipment controls in terms of fissile material, controlled shipments. Section 173.461. This section, ``Demonstration of compliance with tests,'' is amended to clarify that surrogate materials may be used in packagings to demonstrate compliance with the performance requirements for the package. Sections 173.462-173.467. These sections are revised to correct section references and terminology. Section 173.468. This section, ``Test for LSA-III material'', is added to specify a leaching test to examine the solid nature of the material for qualification of the material as LSA-III. One commenter asked that the section be clarified to state whether immersion tests must be conducted on full-scale or on represented small scale samples. RSPA never intended to disallow the provisions of Sec. 173.461, which allows scale model testing, for the tests required in Sec. 173.468. The second sentence of proposed Sec. 173.468(a), which stated that ``[e]ach solid specimen to be tested must be representative of the actual solid LSA-III material that will be transported'', might have been misinterpreted. To clarify that a representative scale model sample may be used as the test specimen, RSPA is not adopting that sentence. Section 173.469. This section, ``Tests for special form Class 7 (radioactive) material,'' is amended to add an alternative method to qualify special form radioactive material under the specific impact and temperature tests prescribed in the specified standard of the International Organization for Standardization (ISO). One commenter stated that the ISO standard allowed leakage and leaching tests that are not as sensitive as the tests prescribed in Sec. 173.469(a)(4) and (b) and, therefore, should not be adopted. RSPA agrees that some of the ISO test methods are not as sensitive for some source designs as those prescribed in the regulations. However, ISO's test method has a lower acceptance criteria which compensates for the less sensitive test methods. Therefore, RSPA is not adopting this commenters request. Sections 173.471-173.473. These sections are amended to require that applicants for Competent Authority Approvals of Type B packaging designs, including those requesting to become registered users, submit a description to RSPA of the quality assurance program in effect during the design, manufacture, testing, documentation, use, maintenance, and inspection of the package as required by IAEA. These sections are also amended to require that submissions be made in triplicate and 90 days in advance of the shipment. It should be noted that IAEA regulations require that the serial number be marked on Type B packagings. Though not required by RSPA in this final rule, packages shipped in accordance with the IAEA regulations will be required to be marked with the serial number of the packaging. Sections 173.474-173.475. These section are not amended but are reprinted for ease of understanding. Section 173.476. This section, ``Approval of special form Class 7 (radioactive) materials,'' is amended to require that the original applicant provide evidence of the quality assurance program in effect during the design, manufacture, testing, documentation, use, maintenance, and inspection of the material as required by IAEA. In addition, this section is amended to require that submissions be made in triplicate and 90 days in advance of the shipment. Section 173.477. This section, ``Approval for export shipments,'' is amended to delete references to fissile classes. Additionally, a new subparagraph addresses the contents of an application for shipment approval under special arrangement. Section 173.478. This section, ``Notification to competent authorities for export shipments,'' is amended to delete references to fissile classes and requires additional information to be submitted to other national competent authorities for special arrangement shipments. Specifically, notification of a special arrangement shipment is required to include the name of the radionuclide, a description of the physical and chemical form, and the activity of the material. Section 174.705. This section, entitled ``Radiation Protection Program,'' is added to prohibit the transport of radioactive material by a rail carrier that does not maintain a radiation protection program for each of its occupationally exposed hazmat employees as required by subpart I of part 172. For further discussion of these requirements, see section III.A of this preamble. Section 175.704. This section has been added, which incorporates proposed 10 CFR 71.88(c), as proposed by NRC. This new section imposes loading and storage restrictions on packages of plutonium. Because these requirements are more appropriate to 49 CFR part 175 than in 10 CFR part 71, RSPA is adopting them in this section. Section 175.706. This section, entitled ``Radiation Protection Program,'' is added to prohibit the transport of radioactive material by an air carrier that does not maintain a radiation protection program for each of its occupationally exposed hazmat employees as required by subpart I of part 172. For further discussion of these requirements, see section III.A of this preamble. Section 176.703. This section, entitled ``Radiation Protection Program,'' is added to prohibit the transport of radioactive material by a vessel operator that does not maintain a radiation protection program for each of its occupationally exposed hazmat employees as required by subpart I of part 172. For further discussion of these requirements, see section III.A of this preamble. Section 177.827. This section, entitled ``Radiation Protection Program,'' is added to prohibit the transport of radioactive material by a motor carrier that does not maintain a radiation protection program for each of its occupationally exposed hazmat employees as required by subpart I of part 172. For further discussion of these requirements, see section III.A of this preamble. In addition to the foregoing section changes, other sections contained in parts 174 through part 178, involving radioactive material transportation, have been updated to for consistency with changes in parts 171 through part 173. Some of these changes include the addition of metric and SI units and changes in regulatory references. The following is list of those sections: ------------------------------------------------------------------------ Part 174 Part 175 Part 176 Part 177 Part 178 ------------------------------------------------------------------------ 174.700............. 175.700 176.700 177.842 178.350 [[Page 50301]] 174.715............. 175.702 176.704 177.843 ........... 174.750............. 175.703 176.708 177.861 ........... ........... 176.715 ........... ........... ------------------------------------------------------------------------ V. Regulatory Analyses and Notices Executive Order 12866 and DOT Regulatory Policies and Procedures This final rule is not considered a significant regulatory action under section 3(f) of Executive Order 12866 and was not reviewed by the Office of Management and Budget. The rule is not considered significant under the regulatory policies and procedures of the Department of Transportation (44 FR 11034). A regulatory evaluation is available for review in the docket. Executive Order 12612 This final rule has been analyzed in accordance with the principles and criteria contained in Executive Order 12612 (``Federalism''). The Federal hazardous materials transportation law (49 USC 5101-5127) contains an express preemption provision that preempts State, local, and Indian tribe requirements on certain covered subjects. Covered subjects are: (i) The designation, description, and classification of hazardous materials; (ii) The packing, repacking, handling, labeling, marking, and placarding of hazardous materials; (iii) The preparation, execution, and use of shipping documents pertaining to hazardous materials and requirements respecting the number, content, and placement of such documents; (iv) The written notification, recording, and reporting of the unintentional release in transportation of hazardous materials; or (v) The design, manufacturing, fabrication, marking, maintenance, reconditioning, repairing, or testing of a package or container which is represented, marked, certified, or sold as qualified for use in the transportation of hazardous materials. This final rule concerns the packaging and classification of radioactive materials. This final rule preempts State, local, or Indian tribe requirements in accordance with the standards set forth above. The Federal statute provides that if DOT issues a regulation concerning any of the covered subjects after November 16, 1990, DOT must determine and publish in the Federal Register the effective date of Federal preemption (49 USC 5125(b)(2)). That effective date may not be earlier than the 90th day following the date of issuance of the final rule and not later than two years after the date of issuance. RSPA has determined that the effective date of Federal preemption for these requirements is April 1, 1996. Thus RSPA lacks discretion in this area, and preparation of a federalism assessment is not warranted. Executive Order 12778 Any interested person may petition RSPA's Administrator for reconsideration of this final rule within 30 days of publication of this rule in the Federal Register, in accordance with the procedures set forth at 49 CFR 106.35. Neither the filing of a petition for reconsideration nor any other administrative proceeding is required before the filing of a suit in court for review of this rule. Regulatory Flexibility Act I certify that this final rule will not have a significant economic impact on a substantial number of small entities. This rule applies to shippers and carriers of radioactive materials, some of whom are small entities. Paperwork Reduction Act The information collection requirements contained in this rule have been approved by the Office of Management and Budget under the provisions of the Paperwork Reduction Act of 1980 (44 U.S.C. 3504(h)) and assigned control number 2137-0510. Regulation Identifier Number (RIN) A regulation identifier number (RIN) is assigned to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. The RIN number contained in the heading of this document can be used to cross-reference this action with the Unified Agenda. List of Subjects 49 CFR Part 171 Exports, Hazardous materials transportation, Hazardous waste, Imports, Incorporation by reference, Reporting and recordkeeping requirements. 49 CFR Part 172 Hazardous materials transportation, Hazardous waste, Labeling, Packaging and containers, Reporting and recordkeeping requirements. 49 CFR Part 173 Hazardous materials transportation, Incorporation by reference, Packaging and containers, Radioactive materials, Reporting and recordkeeping requirements, Uranium. 49 CFR Part 174 Hazardous materials transportation, Radioactive materials, Railroad safety. 49 CFR Part 175 Air carriers, Hazardous materials transportation, Radioactive materials, Reporting and recordkeeping requirements. 49 CFR Part 176 Hazardous materials transportation, Maritime carriers, Radioactive materials, Reporting and recordkeeping requirements. 49 CFR Part 177 Hazardous materials transportation, Motor carriers, Radioactive materials, Reporting and recordkeeping requirements. 49 CFR Part 178 Hazardous materials transportation, Packaging and containers, Reporting and recordkeeping requirements. In consideration of the foregoing, 49 CFR parts 171, 172, 173, 174, 175, 176, 177 and 178 are amended as follows: PART 171--GENERAL INFORMATION, REGULATIONS, AND DEFINITIONS 1. The authority citation for part 171 continues to read as follows: Authority: 49 U.S.C. 5101-5127; 49 CFR part 1.53. Sec. 171.7 [Amended] 2. In Sec. 171.7, the Table of material incorporated by reference, in paragraph (a)(3), is amended by removing the entry for ``USAEC, ORO- 651,'' under the Department of Energy (USDOE), revising the entry for ``IAEA, Regulations for the Safe Transport of Radioactive Materials, Safety Series No. 6,'' under the International Atomic Energy Agency (IAEA) and by adding an entry for ``ORO-651'' under the Department of Energy and three new entries following [[Page 50302]] the exiting entries, under the International Organization for Standardization, to read as follows: ------------------------------------------------------------------------ 49 CFR Source and name of material reference ------------------------------------------------------------------------ Department of Energy (USDOE) * * * * * * * ORO-651 - Uranium Hexafluoride; A Manual of Good Practices, Revision 6, 1991 edition.................................. 173.417 * * * * * * * International Atomic Energy Agency (IAEA), * * * * * * * IAEA, Regulations for the Safe Transport of Radioactive Materials, Safety Series No. 6, 1985 Edition (As Amended 1990); Including 1985 Edition (Supplemented 1986 and 1988) 171.12 * * * * * * * International Organization for Standardization (ISO) * * * * * * * ISO/TR 4826-1979(E) - Sealed radioactive sources--Leak test methods................................................... 173.469 ISO 2919-1980(E) - Sealed radioactive sources-- Classification............................................ 173.469 ISO 1496-3-1995(E) - Series 1 Freight Containers-- Specification and Testing--Part 3: Tank Containers for Liquids, Gases and Pressurized Dry Bulk................... 173.411 * * * * * * * ------------------------------------------------------------------------ * * * * * 3. In Sec. 171.8, the following definitions are added in appropriate alphabetical order to read as follows: Sec. 171.8 Definitions and abbreviations. * * * * * General public means, for purposes of subpart I of part 172, and subpart I of part 173 of this subchapter, any person other than an occupationally exposed hazmat employee. * * * * * Occupationally exposed hazmat employee means a hazmat employee whose duties involve exposure to ionizing radiation. * * * * * 4. In Sec. 171.10(c)(2), the ``Table of Conversion Factors For SI Units'' is amended by adding the following entries in appropriate alphabetical order and the note following the table is revised to read as follows: Sec. 171.10 Units of measure. * * * * * (c) * * * (2) * * * Table of Conversion Factors For SI Units ------------------------------------------------------------------------ Measurement SI to US standard US standard to SI ------------------------------------------------------------------------ Activity............... 1 TBq=27 Ci............ 1 Ci=0.037 TBq. * * * * * * * Radiation level........ 1 Sv/hr=100 rem/hr..... 1 rem/hr=0.01 Sv/hr ------------------------------------------------------------------------ Abbreviation for units of measure are as follows: Unit of measure and abbreviation: (SI): millimeter, mm; centimeter, cm; meter, m; gram, g; kilogram, kg; kiloPascal, kPa; liter, L; milliliter, ml; cubic meter, m \3\; Terabecquerel, TBq; Gigabecquerel, GBq; millisievert, mSv; (U.S.): Inch, in; foot, ft; ounce, oz; pound, lb; pounds per square inch, psi; gallon, gal; cubic feet, ft \3\; Curie, Ci; millicurie, mCi; millirem, mrem. 5. Section 171.11(d)(6)(iii) is revised to read as follows: Sec. 171.11 Use of ICAO Technical Instructions. * * * * * (d) * * * (6) * * * (iii) Except for limited quantities of Class 7 (radioactive) material, the provisions of Secs. 172.204(c)(4), 173.448(e), (f) and (g)(3) of this subchapter apply. * * * * * Sec. 171.11 [Amended] 6. In addition, in Sec. 171.11(d)(6)(iv), remove the words ``Sec. 173.422 or Sec. 173.424'' and add, in their place, the words ``Sec. 173.424 or Sec. 173.426''. 7. In Sec. 171.12, the heading and introductory text of paragraph (d) and paragraph (d)(4) are revised, paragraph (d)(5) is amended by removing the period and adding ``; and'' in its place, and paragraph (d)(6) is added to read as follows: Sec. 171.12 Import and export shipments. * * * * * (d) Use of IAEA regulations for Class 7 (radioactive) materials. Class 7 (radioactive) materials being imported into, or exported from, the United States, or passing through the United States in the course of being shipped between places outside the United States, may be offered and accepted for transportation when packaged, marked, labeled, and otherwise prepared for shipment in accordance with IAEA ``Regulations for the Safe Transport of Radioactive Materials, Safety Series No. 6,'' if: * * * * * [[Page 50303]] (4) The country of origin for the shipment has adopted the IAEA ``Regulations for the Safe Transport of Radioactive Materials, Safety Series No. 6''; * * * * * (6) Shipments comply with the requirements for emergency response information prescribed in Subpart G of Part 172 of this subchapter. PART 172--HAZARDOUS MATERIALS TABLE, SPECIAL PROVISIONS, HAZARDOUS MATERIALS COMMUNICATIONS, EMERGENCY RESPONSE INFORMATION, AND TRAINING REQUIREMENTS 8. The authority citation for Part 172 continues to read as follows: Authority: 49 U.S.C. 5101-5127; 49 CFR part 1.53. 9. The following entries in the Sec. 172.101 Hazardous Materials Table are removed, added in alphabetical order or revised to read as follows: Sec. 172.101 Purpose and use of hazardous materials table. * * * * * Sec. 172.101 Hazardous Materials Table ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ (8) Packaging authorizations (9) Quantity (10) Vessel stowage (Sec. 173.***) limitations requirements (2)Hazard Label(s) --------------------------------------------------------------------------- Symbols (1)Hazardous materials descriptions and class or (3)Identification Packing required Special Passenger proper shipping names Division Numbers group (if not provisions Nonbulk Bulk aircraft Cargo Vessel Other excepted) Exceptions packaging packaging or aircraft stowage stowage railcar only provisions (1) (2)..................................... (3) (4) (5) (6)....... (7) (8A)...... (8B)..... (8C)..... (9A) (9B) (10A) (10B) ........................................ [Remove] Radioactive material, excepted package- 7 UN2910 ........... EMPTY..... .......... 427....... 427...... 427...... ......... ........ A empty packaging. * * * * * * * Radioactive material, low specific activity, n.o.s. or Radioactive material, LSA, n.o.s.. [Add] * * * * * * * Radioactive material, excepted package- 7 UN2910 ........... EMPTY..... .......... 421, 428.. 421, 428. 421, 428. ......... ........ A empty package or empty packaging. * * * * * * * Radioactive material, low specific 7 UN2912 ........... RADIO- .......... 421, 428.. 427...... 427...... ......... ........ A .......... activity or Radioactive material, LSA, ACTIVE. n.o.s. * * * * * * * Radioactive material, surface 7 UN2913 ........... RADIO- 421, 424, 427....... 427...... ......... ......... A contaminated object or Radioactive ACTIVE. 426 material, SCO. * * * * * * * [Revise] * * * * * * * Radioactive material, excepted package- 7 UN2910 ........... None...... .......... 422, 426.. 422, 426. 422, 426. ......... ........ A articles manufactured from natural or depleted uranium or natural thorium. * * * * * * * Radioactive material, excepted package- 7 UN2910 ........... None...... .......... 422, 424.. 422, 424. 422, 424. ......... ........ A instruments or articles. [[Page 50304]] Radioactive material, excepted package- 7 UN2910 ........... None...... .......... 421, 422.. 421, 422. 421, 422. ......... ........ A limited quantity of material. * * * * * * * Radioactive material, n.o.s............. 7 UN2982 ........... RADIO- .......... 421, 428.. 415, 416. 415, 416. ......... ........ A 40, 95 ACTIVE. Radioactive material, special form, 7 UN2974 ........... RADIO- .......... 421, 424.. 415, 416. 415, 416. ......... ........ A n.o.s.. ACTIVE. * * * * * * * ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Sec. 172.101 [Amended] 10. In addition, in Sec. 172.101, in the Hazardous Materials Table, for the entry ``Uranium hexafluoride, fissile excepted or non-fissile'' the column (8A) section reference ``421-2'' is revised to read ``423''. 11. In Sec. 172.203, paragraphs (d)(1), (d)(4), and (d)(7) are revised and paragraphs (d)(10) and (d)(11) are added to read as follows: Sec. 172.203 Additional description requirements. * * * * * (d) * * * (1) The name of each radionuclide in the Class 7 (radioactive) material that is listed in Sec. 173.435 of this subchapter. For mixtures of radionuclides, the radionuclides that must be shown must be determined in accordance with Sec. 173.433(f) of this subchapter. * * * * * (4) The activity contained in each package of the shipment in terms of the appropriate SI units (e.g. Becquerel, Terabecquerel, etc.) or in terms of the appropriate SI units followed by the customary units (e.g. Curies, millicuries, etc.). Alternatively, for domestic transportation, the activity in a package of Class 7 (radioactive) materials may be described solely in terms of curies until April 1, 1997. Abbreviations are authorized. Except for plutonium-238, plutonium-239, and plutonium- 241, the weight in grams or kilograms of fissile radionuclides may be inserted instead of activity units. For plutonium-238, plutonium-239, and plutonium-241 the weight in grams or kilograms of fissile radionuclides may be inserted in addition to the activity units. For the shipment of a package containing a highway route controlled quantity of Class 7 (radioactive) materials (see Sec. 173.403 of this subchapter) the words ``Highway route controlled quantity'' must be entered in association with the basic description. * * * * * (7) For a shipment of fissile Class 7 (radioactive) materials: (i) The words ``Fissile Excepted'' if the package is excepted pursuant to Sec. 173.453 of this subchapter; (ii) For a fissile material, controlled shipment, the additional notation: ``Warning--Fissile material, controlled shipment. Do not load more than * * * packages per vehicle.'' (Asterisks to be replaced by appropriate number.) ``In loading and storage areas, keep at least 6 meters (20 feet) from other packages bearing radioactive labels''; and (iii) If a fissile material, controlled shipment is to be transported by water, the supplementary notation must also include the following statement: ``For shipment by water, only one fissile material, controlled shipment is permitted in each hold.'' * * * * * (10) For a shipment required by this subchapter to be consigned as exclusive use: (i) An indication that the shipment is consigned as exclusive use; or (ii) If all the descriptions on the shipping paper are consigned as exclusive use, then the statement ``Exclusive Use Shipment'' may be entered only once on the shipping paper in a clearly visible location. (11) For a shipment of low specific activity material or surface contaminated objects, the appropriate group notation of LSA-I, LSA-II, LSA-III, SCO-I, or SCO-II. * * * * * 12. Section 172.310 is revised to read as follows: Sec. 172.310 Class 7 (radioactive) materials. In addition to any other markings required by this subpart, each package containing Class 7 (radioactive) materials must be marked as follows: (a) Each package with a gross mass greater than 50 kilograms (110 pounds) must have the its gross mass marked on the outside of the package. (b) packaging must be marked on the outside of the package, in letters at least 13 mm (0.5 inch) high, with the words ``TYPE A'' or ``TYPE B'' as appropriate. A packaging which does not conform to Type A or Type B requirements may not be so marked. (c) Each Type B, Type B(U) or Type B(M) packaging must be marked on the outside of the package with a radiation symbol that conforms to the requirements of Appendix B to Part 172. (d) Each package destined for export shipment must also be marked ``USA'' in conjunction with the specification marking, or other package certificate identification. (See Secs. 173.471, 173.472, and 173.473 of this subchapter). [[Page 50305]] 13. In Sec. 172.403, the section heading, and paragraphs (b), (c), (d), (g)(1) and (g)(2) are revised to read as follows: Sec. 172.403 Class 7 (radioactive) material. * * * * * (b) The proper label to affix to a package of Class 7 (radioactive) material is based on the radiation level at the surface of the package and the transport index. The proper category of label must be determined in accordance with paragraph (c) of this section. The label to be applied must be the highest category required for any of the two determining conditions for the package. RADIOACTIVE WHITE-I is the lowest category and RADIOACTIVE YELLOW-III is the highest. For example, a package with a transport index of 0.8 and a maximum surface radiation level of 0.6 millisievert (60 millirems) per hour must bear a RADIOACTIVE YELLOW-III label. (c) Category of label to be applied to Class 7 (radioactive) materials packages: ------------------------------------------------------------------------ Maximum radiation Transport index level at any point on Label category1 the external surface ------------------------------------------------------------------------ 02...................... Less than or equal to WHITE-I. 0.005 mSv/h (0.5 mrem/ h). More than 0 but not more Greater than 0.005 mSv/ YELLOW-II. than 1. h (0.5 mrem/h) but less than or equal to 0.5 mSv/h (50 mrem). More than 1 but not more Greater than 0.05 mSv/ YELLOW-III. than 10. h (50 mrem) but less than or equal to 2 mSv/h (200 mrem/h). More than 10............ Greater than 2 mSv/h YELLOW-III (Must be (200 mrem/h) but less shipped under than or equal to 10 exclusive use mSv/h (1,000 mrem/h). provisions; see 173.441(b) of this subchapter). ------------------------------------------------------------------------ 1 Any package containing a ``highway route controlled quantity'' (Sec. 173.403 of this subchapter) must be labelled as RADIOACTIVE YELLOW- III. 2 If the measured TI is not greater than 0.05, the value may be considered to be zero. (d) EMPTY label. See Sec. 173.428(d) of this subchapter for EMPTY labeling requirements. * * * * * (g) * * * (1) Contents. The name of the radionuclides as taken from the listing of radionuclides in Sec. 173.435 of this subchapter (symbols which conform to established radiation protection terminology are authorized, i.e., \99\Mo, \60\Co, etc.). For mixtures of radionuclides, with consideration of space available on the label, the radionuclides that must be shown must be determined in accordance with Sec. 173.433(f) of this subchapter. (2) Activity. Activity units must be expressed in appropriate SI units (e.g., Becquerels (Bq), Terabecquerels (TBq), etc.) or in both appropriate SI units and appropriate customary units (Curies (Ci), milliCuries (mCi), microcuries (uCi), etc.). Alternatively, the activity may be expressed solely in terms of curies until April 1, 1997. Abbreviations are authorized. Except for plutonium-238, plutonium-239, and plutonium-241, the weight in grams or kilograms of fissile radionuclides may be inserted instead of activity units. For plutonium-238, plutonium-239, and plutonium-241, the weight in grams or kilograms of fissile radionuclides may be inserted in addition to the activity units. * * * * * 14. In Sec. 172.407, paragraph (g) is added to read as follows: Sec. 172.407 Label specifications. * * * * * (g) Trefoil symbol. The trefoil symbol on the RADIOACTIVE WHITE-I, RADIOACTIVE YELLOW-II, and RADIOACTIVE YELLOW-III labels must meet the appropriate specifications in Appendix B of this part. Sec. 172.504 [Amended] 15. In Sec. 172.504, in Table 1 of paragraph (e), footnote one is revised to read as follows: \1\ RADIOACTIVE placard also required for exclusive use shipments of low specific activity material and surface contaminated objects transported in accordance with Sec. 173.427(b)(3) or (c) of this subchapter. 16. In Sec. 172.507, paragraph (a) is revised to read as follows: Sec. 172.507 Special placarding provisions: Highway. (a) Each motor vehicle used to transport a package of highway route controlled quantity Class 7 (radioactive) materials (see Sec. 173.403 of this subchapter) must have the required RADIOACTIVE warning placard placed on a square background as described in Sec. 172.527. * * * * * 17. In Sec. 172.519, paragraph (g) is added to read as follows: Sec. 172.519 General specifications for placards. * * * * * (g) Trefoil symbol. The trefoil symbol on the RADIOACTIVE placard must meet the appropriate specification in Appendix B of this part. 18. A new subpart I is added to part 172 to read as follows: Subpart I--Radiation Protection Program Sec. 172.801 Applicability of the radiation protection program. 172.803 Radiation protection program. 172.805 Recordkeeping and notifications. 172.807 Transitional provisions. Subpart I--Radiation Protection Program Sec. 172.801 Applicability of the radiation protection program. (a) Scope. This subpart prescribes requirements for developing and maintaining a radiation protection program. (b) Applicability. This subpart applies to persons who offer for transportation, accept for transportation, or transports Class 7 (radioactive) materials. Sec. 172.803 Radiation protection program. Each person who offers for transportation, accepts for transportation, or transports Class 7 (radioactive) materials must develop, implement and maintain a written radiation protection program in accordance with the following: (a) Radiation exposures must be kept as low as reasonably achievable (ALARA), with economic and social factors being taken into account. (b) Radiation exposures must be control such that: (1) An occupationally exposed hazmat employee's annual effective dose equivalent for occupational radiation exposure will not exceed 12.5 mSv (1.25 rem) in any 3 month period or 50 mSv (5 rem) in any 12 month period. For workers under the age of eighteen, the radiation dose will not exceed 1.250 [[Page 50306]] mSv (0.125 rem) in any 3 month period or 5.0 mSv (0.5 rem) in any 12 month period; (2) Radiation exposures to members of the general public must be less than 0.02 mSv (2 mrem) per hour. This level will be measured as if an individual were present for an hour in any area where the general public could be exposed to radiation during the course of transportation, except that, if there is an occurrence where the dose to a member of the general public equals or exceeds 0.02 mSv (2 mrem) in one hour, the program must provide limits that will prevent an individual from receiving cumulative doses totaling 1.0 mSv (100 mrem) in any week or 5.0 mSv (500 mrem) in any twelve-month period; (3) The radiation dose to an embryo-fetus in a pregnant female occupationally exposed hazmat employee, who has declared her pregnancy to her employer, must not exceed 5.0 mSv (500 mrem) during the pregnancy. This limit is to be achieved by limiting the radiation dose of the declared pregnant worker to not more than 5.0 mSv (500 mrem) during the nine months and not greater than 0.5 mSv (50 mrem) in any one month; and (4) The radiation doses received by occupationally exposed hazmat employees must be monitored by radiation dosimetry devices. (c) The Environmental Protection Agency report entitled ``Radiation Protection Guidance to Federal Agencies for Occupational Exposure (January 1987)''. This document is available from the U.S. Environmental Protection Agency, Washington, DC 20460. (d) Exceptions. (1) The requirements of this subpart do not apply to: (i) Persons who offer for transportation or transport less than 200 TI of packages in a 12-month period; or (ii) Those persons whose operations will not result in a hazmat employee receiving an exposure of 5 mSv (500 mrem) or more per year. This evaluation must consider the hazmat employers Class 7 (radioactive) materials transportation activities for a period of at least 12 months. An evaluation must be conducted by a person experienced with radiation protection programs and transportation regulations and programs. The evaluator's competency may be evidenced by being certified by the American Board of Health Physics, or by a letter of recommendation from any Regional Administrator of the Nuclear Regulatory Commission or from a State Radiation Official listed in the most current issue of the ``Directory of Personnel Responsible For Radiological Health Programs'' published annually by the Conference of Radiation Control Program Directors, Frankfort, KY. (2) The requirements of this subpart may be satisfied by any radiation protection program that has been approved by an appropriate federal or state agency. (e) Guidance. Each hazmat employer should review and follow the guidance provided in the following documents when establishing and maintaining their radiation protection program: (i) National Council on Radiation Protection and Measurements (NCRP) Report No. 59, ``Operational Radiation Safety Program (1978)''. The guidance in this report should be tailored to the practical needs and operations of the hazmat employer and their occupationally exposed hazmat employees. (ii) NCRP Report No. 116, ``Limitation of Exposure to Ionizing Radiation (1993)''. (2) The reports referenced in paragraph (e)(1) of this section are available from NCRP Publications, 7910 Woodmont Avenue, Bethesda, MD 20814. Sec. 172.805 Recordkeeping and notifications. (a) A hazmat employer must document their radiation protection program and maintain written records of the radiation protection program activities, including dosimetry records, described in this subpart. These records must be made available to the Associate Administrator for Hazardous Materials Safety or other authorized officials in written form within seven days of a written request. (b) A hazmat employer must keep a record of the radiation dose that each hazmat employee has received and provide it to the employee in reasonable time following a request during employment and no more than three months after end of employment. (c) Each hazmat employer must notify the Associate Administrator for Hazardous Materials Safety, in writing, if a hazmat employee receives a dose exceeding 12.5 mSv (1250 mrem) in any calendar quarter or 50 mSv (5,000 mrem) in one year, or if a member of the general public is likely to receive a dose exceeding 5 mSv (500 mrem) in one year as a result of the hazmat employer's transportation activities. Such a notification must be made as soon as practicable following awareness of the occurrence. (d) If an offeror or carrier of Class 7 (radioactive) materials is not required to establish a radiation protection program, they must develop and keep records which demonstrate why a program is not required (i.e., either the total TI of packages transported in any 12 month period is less than 200, or that the current Class 7 (radioactive) materials transport activities are the same as the activities that were reviewed by a competent radiation protection specialist whose evaluation demonstrated that no worker will receive a dose exceeding 5 mSv (500 mrem) in one year). Sec. 172.807 Transitional provisions. Compliance with the requirements of this subpart is required after October 1, 1997. 19. APPENDIX B is added to Part 172 to read as follows: Appendix B to Part 172--Trefoil Symbol The trefoil symbol required for RADIOACTIVE labels and placards, and required to be marked on certain packages of Class 7 (radioactive) material, must conform to the following design and size: BILLING CODE 4910-60-P [[Page 50307]] [GRAPHIC][TIFF OMITTED]TR28SE95.005 BILLING CODE 4910-60-C 1= Radius of Circle-- Minimum Dimensions 4 mm (0.16 inch) for markings 5 mm (0.2 inch) for labels 12.5 mm (0.5 inch) for placards 2= 1 1/2 Radii 3= 5 Radii PART 173--SHIPPERS--GENERAL REQUIREMENTS FOR SHIPMENTS AND PACKAGINGS 20. The authority citation for Part 173 continues to read as follows: Authority: 49 U.S.C. 5101-5127; 49 CFR part 1.53. Sec. 173.2a [Amended] 21. In Sec. 173.2a(c)(5), the phrase ``Sec. 173.421-2'' is removed and replaced with the phrase ``Sec. 173.423''. 22. In Sec. 173.4, paragraphs (a)(1)(iv) and (b) are revised to read as follows: Sec. 173.4 Exceptions for small quantities. (a) * * * (1) * * * (iv) An activity level not exceeding that specified in Secs. 173.421, 173.424, 173.425 or 173.426, as appropriate, for a package containing a Class 7 (radioactive) material. * * * * * (b) A package containing a Class 7 (radioactive) material also must conform to the requirements of Sec. 173.421(a)(1) through (a)(5) or Sec. 173.424(a) through (g), as appropriate. 23. Subpart I of Part 173 is revised to read as follows: Subpart I-Class 7 (Radioactive) Materials 173.401 Scope. 173.403 Definitions. 173.410 General design requirements. 173.411 Industrial packagings. 173.412 Additional design requirements for Type A packages. 173.413 Requirements for Type B packages. 173.415 Authorized Type A packages. 173.416 Authorized Type B packages. 173.417 Authorized fissile materials packages. 173.418 Authorized packages--pyrophoric Class 7 (radioactive) materials. 173.419 Authorized packages--oxidizing Class 7 (radioactive) materials. 173.420 Uranium hexafluoride (fissile, fissile excepted and non- fissile). 173.421 Excepted packages for limited quantities of Class 7 (radioactive) materials. 173.422 Additional requirements for excepted packages containing Class 7 (radioactive) materials. 173.423 Requirements for multiple hazard limited quantity Class 7 (radioactive) materials. 173.424 Excepted packages for radioactive instruments and articles. 173.425 Table of activity limits--excepted quantities and articles. [[Page 50308]] 173.426 Excepted packages for articles containing natural uranium or thorium. 173.427 Transport requirements for low specific activity (LSA) Class 7 (radioactive) materials and surface contaminated objects (SCO). 173.428 Empty Class 7 (radioactive) materials packaging. 173.431 Activity limits for Type A and Type B packages. 173.433 Requirements for determining A1 and A2 values for radionuclides and for the listing of radionuclides on shipping papers and labels. 173.434 Activity-mass relationships for uranium and natural thorium. 173.435 Table of A1 and A2 values for radionuclides. 173.441 Radiation level limitations. 173.442 Thermal limitations. 173.443 Contamination control. 173.444 Labeling requirements. 173.446 Placarding requirements. 173.447 Storage incident to transportation--general requirements. 173.448 General transportation requirements. 173.451 Fissile materials--general requirements. 173.453 Fissile materials--exceptions. 173.457 Transportation of fissile material, controlled shipments-- specific requirements. 173.459 Mixing of fissile material packages. 173.461 Demonstration of compliance with tests. 173.462 Preparation of specimens for testing. 173.463 Packaging and shielding--testing for integrity. 173.465 Type A packaging tests. 173.466 Additional tests for Type A packagings designed for liquids and gases. 173.467 Tests for demonstrating the ability of Type B and fissile materials packagings to withstand accident conditions in transportation. 173.468 Test for LSA-III material. 173.469 Tests for special form Class 7 (radioactive) materials. 173.471 Requirements for U.S. Nuclear Regulatory Commission approved packages. 173.472 Requirements for exporting DOT Specification Type B and fissile packages. 173.473 Requirements for foreign-made packages. 173.474 Quality control for construction of packaging. 173.475 Quality control requirements prior to each shipment of Class 7 (radioactive) materials. 173.476 Approval of special form Class 7 (radioactive) materials. 173.477 Approval for export shipments. 173.478 Notification to competent authorities for export shipments. Subpart I--Class 7 (Radioactive) Materials Sec. 173.401 Scope. (a) This subpart sets forth requirements for the packaging and transportation of Class 7 (radioactive) materials by offerors and carriers subject to this subchapter. The requirements prescribed in this subpart are in addition to, not in place of, other requirements set forth in this subchapter for Class 7 (radioactive) materials and those of the Nuclear Regulatory Commission in 10 CFR Part 71. (b) This subpart does not apply to: (1) Class 7 (radioactive) materials produced, used, transported, or stored within an establishment other than during the course of transportation, including storage in transportation. (2) Class 7 (radioactive) materials contained in a medical device, such as a heart pacemaker, which is implanted in a human being or live animal. (3) Class 7 (radioactive) materials that have been injected into, ingested by, or are otherwise placed into, and are still in, human beings or live animals. Sec. 173.403 Definitions. For purposes of this subpart-- A1 means the maximum activity of special form Class 7 (radioactive) material permitted in a Type A package. A2 means the maximum activity of Class 7 (radioactive) material, other than special form, LSA or SCO, permitted in a Type A package. These values are either listed in Sec. 173.435 or derived in accordance with the procedure prescribed in Sec. 173.433. Class 7 (radioactive) material. See the definition of Radioactive material in this section. Closed transport vehicle means a transport vehicle or conveyance equipped with a securely attached exterior enclosure that during normal transportation restricts the access of unauthorized persons to the cargo space containing the Class 7 (radioactive) materials. The enclosure may be either temporary or permanent, and in the case of packaged materials may be of the ``see-through'' type, and must limit access from top, sides, and bottom. Containment system means the assembly of components of the packaging intended to retain the radioactive contents during transportation. Conveyance means: (1) For transport by public highway or rail: any transport vehicle or large freight container; (2) For transport by water: any vessel, or any hold, compartment, or defined deck area of a vessel including any transport vehicle on board the vessel; and (3) For transport by aircraft, any aircraft. Design means the description of a special form Class 7 (radioactive) material, a package, packaging, or LSA-III, that enables those items to be fully identified. The description may include specifications, engineering drawings, reports showing compliance with regulatory requirements, and other relevant documentation. Exclusive use (also referred to in other regulations as ``sole use'' or ``full load'') means sole use by a single consignor of a conveyance for which all initial, intermediate, and final loading and unloading are carried out in accordance with the direction of the consignor or consignee. The consignor and the carrier must ensure that any loading or unloading is performed by personnel having radiological training and resources appropriate for safe handling of the consignment. The consignor must issue specific instructions in writing, for maintenance of exclusive use shipment controls, and include them with the shipping paper information provided to the carrier by the consignor. Fissile material means plutonium-238, plutonium-239, plutonium-241, uranium-233, uranium-235, or any combination of these radionuclides. The definition does not apply to unirradiated natural uranium and depleted uranium, and natural uranium or depleted uranium that has been irradiated in a thermal reactor. Certain additional exceptions are provided in Sec. 173.453. Fissile material, controlled shipment means any shipment that contains one or more packages that have been assigned, in accordance with Sec. 173.457, nuclear criticality control transport indices greater than 10. Freight container means a reusable container having a volume of 1.81 cubic meters (64 cubic feet) or more, designed and constructed to permit its being lifted with its contents intact and intended primarily for containment of packages in unit form during transportation. A ``small freight container'' is one which has either one outer dimension less than 1.5 meters (4.9 feet) or an internal volume of not more than 3.0 cubic meters (106 cubic feet). All other freight containers are designated as ``large freight containers.'' Highway route controlled quantity means a quantity within a single package which exceeds: (1) 3,000 times the A1 value of the radionuclides as specified in Sec. 173.435 for special form Class 7 (radioactive) material; (2) 3,000 times the A2 value of the radionuclides as specified in Sec. 173.435 for normal form Class 7 (radioactive) material; or (3) 1,000 TBq (27,000 Ci), whichever is least. [[Page 50309]] Limited quantity of Class 7 (radioactive) material means a quantity of Class 7 (radioactive) material not exceeding the materials package limits specified in Sec. 173.425 and conforming with requirements specified in Sec. 173.421. Low Specific Activity (LSA) material means Class 7 (radioactive) material with limited specific activity which satisfies the descriptions and limits set forth below. Shielding materials surrounding the LSA material may not be considered in determining the estimated average specific activity of the package contents. LSA material must be in one of three groups: (1) LSA-I. (i) Ores containing only naturally occurring radionuclides (e.g., uranium, thorium) and uranium or thorium concentrates of such ores; or (ii) Solid unirradiated natural uranium or depleted uranium or natural thorium or their solid or liquid compounds or mixtures; or (iii) Class 7 (radioactive) material, other than fissile material, for which the A2 value is unlimited; or (iv) Mill tailings, contaminated earth, concrete, rubble, other debris, and activated material in which the Class 7 (radioactive) material is essentially uniformly distributed and the average specific activity does not exceed 10-\6\A2/g. (2) LSA-II. (i) Water with tritium concentration up to 0.8 TBq/liter (20.0 Ci/ liter); or (ii) Material in which the Class 7 (radioactive) material is essentially uniformly distributed and the average specific activity does not exceed 10-\4\A2/g for solids and gases, and 10-\5\A2/g for liquids. (3) LSA-III. Solids (e.g., consolidated wastes, activated materials) that meet the requirements of Sec. 173.468 and which: (i) The Class 7 (radioactive) material is essentially uniformly distributed throughout a solid or a collection of solid objects, or is essentially uniformly distributed in a solid compact binding agent (such as concrete, bitumen, ceramic, etc.); and (ii) The Class 7 (radioactive) material is relatively insoluble, or it is intrinsically contained in a relatively insoluble material, so that, even under loss of packaging, the loss of Class 7 (radioactive) material per package by leaching when placed in water for seven days would not exceed 0.1 A2; and (iii) The average specific activity of the solid does not exceed 2 x 10-\3\A2/g. Low toxicity alpha emitters are: (1) Natural uranium, depleted uranium, and natural thorium; (2) Ores, concentrates or tailings containing uranium-235, uranium- 238, thorium-232, thorium-228 and thorium-230; or (3) Alpha emitters with a half-life of less than 10 days. Maximum normal operating pressure means the maximum gauge pressure that would develop in a receptacle in a period of one year, in the absence of venting or cooling, under the heat conditions specified in 10 CFR 71.71(c)(1) Multilateral approval means approval of a package or shipment by the relevant competent authority of the country of origin and of each country through or into which the package or shipment is to be transported. This definition does not include approval from a country over which Class 7 (radioactive) materials are carried in aircraft, if there is no scheduled stop in that country. Natural thorium means thorium with the naturally occurring distribution of thorium isotopes (essentially 100 percent by weight of thorium-232). Non-fixed radioactive contamination means radioactive contamination that can be readily removed from a surface by wiping with an absorbent material. Non-fixed (removable) radioactive contamination is not significant if it does not exceed the limits specified in Sec. 173.443. Normal form Class 7 (radioactive) material means Class 7 (radioactive) material which has not been demonstrated to qualify as ``special form Class 7 (radioactive) material.'' Package means, for Class 7 (radioactive) materials, the packaging together with its radioactive contents as presented for transport. (1) ``Excepted package'' means a packaging together with its excepted Class 7 (radioactive) materials as specified in Secs. 173.421- 173.426 and 173.428. (2) ``Type A package'' means a packaging that, together with its radioactive contents limited to A1 or A2 as appropriate, meets the requirements of Secs. 173.410 and 173.412 and is designed to retain the integrity of containment and shielding required by this part under normal conditions of transport as demonstrated by the tests set forth in Sec. 173.465 or Sec. 173.466, as appropriate. A Type A package does not require Competent Authority Approval. (3) ``Type B package'' means a Type B packaging that, together with its radioactive contents, is designed to retain the integrity of containment and shielding required by this part when subjected to the normal conditions of transport and hypothetical accident test conditions set forth in 10 CFR Part 71. (i) ``Type B(U) package'' means a Type B packaging that, together with its radioactive contents, for international shipments requires unilateral approval only of the package design and of any stowage provisions that may be necessary for heat dissipation. (ii) ``Type B(M) package'' means a Type B packaging, together with its radioactive contents, that for international shipments requires multilateral approval of the package design, and may require approval of the conditions of shipment. Type B(M) packages are those Type B package designs which have a maximum normal operating pressure of more than 700 kilopascals per square centimeter (100 pounds per square inch) gauge or a relief device which would allow the release of Class 7 (radioactive) material to the environment under the hypothetical accident conditions specified in 10 CFR Part 71. (4) ``Industrial package'' means a packaging that, together with its low specific activity (LSA) material or surface contaminated object (SCO) contents, meets the requirements of Secs. 173.410 and 173.411. Industrial packages are categorized in Sec. 173.411 as either: (i) ``Industrial package Type 1 (IP-1)''; (ii) ``Industrial package Type 2 (IP-2)''; or (iii) ``Industrial package Type 3 (IP-3)''. Packaging means, for Class 7 (radioactive) materials, the assembly of components necessary to ensure compliance with the packaging requirements of this subpart. It may consist of one or more receptacles, absorbent materials, spacing structures, thermal insulation, radiation shielding, service equipment for filling, emptying, venting and pressure relief, and devices for cooling or absorbing mechanical shocks. The conveyance, tie-down system, and auxiliary equipment may sometimes be designated as part of the packaging. Radiation level means the radiation dose-equivalent rate expressed in millisievert(s) per hour or mSv/h (millirem(s) per hour or mrem/h). Neutron flux densities may be converted into radiation levels according to Table 1: [[Page 50310]] Table 1.--Neutron Fluence Rates To Be Regarded as Equivalent to a Radiation Level of 0.01 mSv/h (1 mrem/h) \1\ ------------------------------------------------------------------------ Flux density equivalent to 0.01 mSv/ h (1 mrem/ Energy of neutron h) neutrons per square centimeter per second (n/cm\2\/s) ------------------------------------------------------------------------ Thermal (2.510E-8)MeV...................................... 272.0 1 keV...................................................... 272.0 10 keV..................................................... 281.0 100 keV.................................................... 47.0 500 keV.................................................... 11.0 1 MeV...................................................... 7.5 5 MeV...................................................... 6.4 10 MeV..................................................... 6.7 ------------------------------------------------------------------------ \1\ Flux densities equivalent for energies between those listed in this table may be obtained by linear interpolation. Radioactive contents means a Class 7 (radioactive) material, together with any contaminated liquids or gases within the package. Radioactive instrument and article means any manufactured instrument and article such as an instrument, clock, electronic tube or apparatus, or similar instrument and article having Class 7 (radioactive) material in gaseous or non-dispersible solid form as a component part. Radioactive material means any material having a specific activity greater than 70 Bq per gram (0.002 microcurie per gram) (see definition of ``specific activity''). Special form Class 7 (radioactive) material means Class 7 (radioactive) material which satisfies the following conditions: (1) It is either a single solid piece or is contained in a sealed capsule that can be opened only by destroying the capsule; (2) The piece or capsule has at least one dimension not less than 5 millimeters (0.2 inch); and (3) It satisfies the test requirements of Sec. 173.469. Special form encapsulations designed in accordance with the requirements of Sec. 173.389(g) in effect on June 30, 1983 (see 49 CFR Part 173, revised as of October 1, 1982), and constructed prior to July 1, 1985 and special form encapsulations designed in accordance with the requirements of Sec. 173.403 in effect on March 31, 1996 (see 49 CFR Part 173, revised as of October 1, 1995), and constructed prior to April 1, 1997, may continue to be used. Any other special form encapsulation must meet the requirements of this paragraph. Specific activity of a radionuclide means the activity of the radionuclide per unit mass of that nuclide. The specific activity of a material in which the radionuclide is essentially uniformly distributed is the activity per unit mass of the material. Surface Contaminated Object (SCO) means a solid object which is not itself radioactive but which has Class 7 (radioactive) material distributed on any of its surfaces. SCO must be in one of two groups with surface activity not exceeding the following limits: (1) SCO-I: A solid object on which: (i) The non-fixed contamination on the accessible surface averaged over 300 cm2 (or the area of the surface if less than 300 cm2) does not exceed 4 Bq/cm2 (10-4 microcurie/cm2) for beta and gamma and low toxicity alpha emitters, or 0.4 Bq/cm2 (10-5 microcurie/cm2) for alpha emitters; (ii) The fixed contamination on the accessible surface averaged over 300 cm2 (or the area of the surface if less than 300 cm2) does not exceed 4 x 104 Bq/cm2 (1.0 microcurie/ cm2) for beta and gamma and low toxicity alpha emitters, or 4 x 103 Bq/cm2 (0.1 microcurie/cm2) for all other alpha emitters; and (iii) The non-fixed contamination plus the fixed contamination on the inaccessible surface averaged over 300 cm2 (or the area of the surface if less than 300 cm2) does not exceed 4 x 104 Bq/ cm2 (1 microcurie/cm2) for beta and gamma and low toxicity alpha emitters, or 4 x 103 Bq/cm2 (0.1 microcurie/cm2) for all other alpha emitters. (2) SCO-II: A solid object on which the limits for SCO-I are exceeded and on which: (i) The non-fixed contamination on the accessible surface averaged over 300 cm2 (or the area of the surface if less than 300 cm2) does not exceed 400 Bq/cm2 (10-2 microcurie/ cm2) for beta and gamma and low toxicity alpha emitters or 40 Bq/ cm2 (10-3 microcurie/cm2) for all other alpha emitters; (ii) The fixed contamination on the accessible surface averaged over 300 cm2 (or the area of the surface if less than 300 cm2) does not exceed 8 x 105 Bq/cm2 (20 microcurie/ cm2) for beta and gamma and low toxicity alpha emitters, or 8 x 104 Bq/cm2 (2 microcuries/cm2) for all other alpha emitters; and (iii) The non-fixed contamination plus the fixed contamination on the inaccessible surface averaged over 300 cm2 (or the area of the surface if less than 300 cm2) does not exceed 8 x 105 Bq/ cm2 (20 microcuries/cm2) for beta and gamma and low toxicity alpha emitters, or 8 x 104 Bq/cm2 (2 microcuries/cm2) for all other alpha emitters. Transport index (TI) means the dimensionless number (rounded up to the next tenth) placed on the label of a package to designate the degree of control to be exercised by the carrier during transportation. The transport index is determined as follows: (1) For nonfissile material packages, the number determined by multiplying the maximum radiation level in milliSievert(s) per hour at one meter (3.3 feet) from the external surface of the package by 100 (equivalent to the maximum radiation level in millirem per hour at one meter (3.3 feet)); or (2) For fissile material packages, the number determined by multiplying the maximum radiation level in milliSievert per hour at one meter (3.3 feet) from any external surface of the package by 100 (equivalent to the maximum radiation level in millirem per hour at one meter (3.3 feet)) or, for criticality control purposes, the number obtained by dividing 50 by the allowable number of packages which may be transported together, whichever number is larger. Type A quantity means a quantity of Class 7 (radioactive) material, the aggregate radioactivity which does not exceed A1 for special form Class 7 (radioactive) material or A2 for normal form Class 7 (radioactive) material, where A1 and A2 values are given in Sec. 173.435 or are determined in accordance with Sec. 173.433. Type B quantity means a quantity of material greater than a Type A quantity. Unilateral approval means approval of a package solely by the competent authority of the country of origin. Unirradiated thorium means thorium containing not more than 10-7 grams uranium-233 per gram of thorium-232. Unirradiated uranium means uranium containing not more than 10-6 grams plutonium per gram of uranium-235 and a fission product activity of not more than 9 MBq (0.24 millicuries) of fission products per gram of uranium-235. Uranium--natural, depleted or enriched means the following: (1) ``Natural uranium'' means uranium with the naturally occurring distribution of uranium isotopes (approximately 0.711 weight percent uranium-235, and the remainder essentially uranium-238). (2) ``Depleted uranium'' means uranium containing less uranium-235 than the naturally occurring distribution of uranium isotopes. (3) ``Enriched uranium'' means uranium containing more uranium-235 than the naturally occurring distribution of uranium isotopes. [[Page 50311]] Sec. 173.410 General design requirements. In addition to the requirements of subparts A and B of this part, each package used for the shipment of Class 7 (radioactive) materials must be designed so that-- (a) The package can be easily handled and properly secured in or on a conveyance during transport. (b) Each lifting attachment that is a structural part of the package must be designed with a minimum safety factor of three against yielding when used to lift the package in the intended manner, and it must be designed so that failure of any lifting attachment under excessive load would not impair the ability of the package to meet other requirements of this subpart. Any other structural part of the package which could be used to lift the package must be capable of being rendered inoperable for lifting the package during transport or must be designed with strength equivalent to that required for lifting attachments. (c) The external surface, as far as practicable, will be free from protruding features and will be easily decontaminated. (d) The outer layer of packaging will avoid, as far as practicable, pockets or crevices where water might collect. (e) Each feature that is added to the package will not reduce the safety of the package. (f) The package will be capable of withstanding the effects of any acceleration, vibration or vibration resonance (see Sec. 178.608 of this subchapter) that may arise under normal conditions of transport without any deterioration in the effectiveness of the closing devices on the various receptacles or in the integrity of the package as a whole and without loosening or unintentionally releasing the nuts, bolts, or other securing devices even [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%3A95-22773. Public record. Not legal advice.