{"operation":"document","citation":"60 FR 50292","title":"Hazardous Materials Transportation Regulations; Compatibility with Regulations of the International Atomic Energy Agency","source_type":"rulemaking","agency":"Research and Special Programs Administration","status":"historical","official":true,"published_on":"1995-09-28","effective_on":null,"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.","machine_formats":{"json":"https://regulus.evalyn.ai/document/federal-register-95-22773.json","markdown":"https://regulus.evalyn.ai/document/federal-register-95-22773.md"},"app_url":"https://regulus.evalyn.ai/document/federal-register-95-22773","source_url":"https://www.federalregister.gov/documents/1995/09/28/95-22773/hazardous-materials-transportation-regulations-compatibility-with-regulations-of-the-international","body":"Federal Register, Volume 60 Issue 188 (Thursday, September 28, 1995) [Federal Register Volume 60, Number 188 (Thursday, September 28, 1995)] [Rules and Regulations] [Pages 50292-50336] From the Federal Register Online via the Government Publishing Office [ www.gpo.gov ] [FR Doc No: 95-22773] [[Page 50291]] _______________________________________________________________________ Part III Department of Transportation _______________________________________________________________________ Research and Special Programs Administration _______________________________________________________________________ 49 CFR Part 171, et al. Hazardous Materials, Transportation Regulations; Compatibility with Regulations of the International Atomic Energy Agency; Final Rule Federal Register / Vol. 60, No. 188 / Thursday, September 28, 1995 / Rules and Regulations [[Page 50292]] DEPARTMENT OF TRANSPORTATION Research and Special Programs Administration 49 CFR Parts 171, 172, 173, 174, 175, 176, 177, and 178 [Docket No. HM-169A; Amdt. Nos. 171-135, 172-143, 173-244, 174-80, 175- 53, 176-37, 177-85, 178-109] RIN 2137-AB60 Hazardous Materials Transportation Regulations; Compatibility with Regulations of the International Atomic Energy Agency AGENCY: Research and Special Programs Administration (RSPA), DOT. ACTION: Final rule. ----------------------------------------------------------------------- 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 A 1 value (2A 1) 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 A 1 value of the radionuclide. Commenters claimed that the 2A 1 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 A 1 value (4A 1). Commenters stated that the IAEA limit of 1 rem/h at 3 meters, a limit 4A 1, or a combination of the two, should replace the proposed 2A 1 limit. One commenter stated that the IAEA limit was impractical and unworkable and favored adoption of a multiple of a A 1 approach (i.e., 4A 1). 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 2A 1 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 2A 1 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 2A 1 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-6A 2/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-6A 2/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-6A 2/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 A 1 and A 2 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 A 2 and A 2 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 A 1 and A 2 values, and the subsequent incorporation of the new values in the HMR, is that most current A 1 and A 2 values have been amended. Of the 284 radionuclide entries in Sec. 173.435, A 2 values have been raised in 129 cases and lowered in 95 cases. Of the A 1 values, 144 have been raised and 73 lowered. Several commenters objected to the proposal to lower the A 2 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 A 1 and A 2 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 A 2 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 A 1 and A 2 values is further described in Appendix I, ``The Q System for the Calculation of A 1 and A 2 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 vibrati","truncated":true,"body_characters":272154}