COMMENTS ON THE IMPLEMENTATION OF RECENT AMENDMENTS TO DOT REGULATIONS CONCERNING THE TRANSPORTATION OF RADIOACTIVE MATERIALS

Richard W. Boyle, Fred D. Ferate II
Office of Hazardous Materials Technology
Research and Special Programs Administration
U. S. Department of Transportation

ABSTRACT

On September 28, 1995, a final rule was published in the Federal Register which introduced changes to the Department of Transportation (DOT) regulations pertaining to the transportation of radioactive materials, in order to bring them more closely into conformance with International Atomic Energy Agency regulations. The effective date of the changes was April 1, 1996, with the exception of the Radiation Protection Program (RPP) requirements, for which the effective date is October 1, 1997. The DOT changes were published in coordination with the Nuclear Regulatory Commission (NRC), which published the new revision of their packaging and radioactive material transportation regulations on the same date.

Changes which may impact the waste management community are changes in A1 and A2 values, changes in shipping paper, marking and labeling requirements, the use of SI units, and the elimination of fissile classes. Changes which will probably have a significant impact are the introduction of industrial packagings, the addition of a new category called Surface Contaminated Objects (SCO), the introduction of LSA and SCO groups, and the RPP requirements for shippers and carriers of radioactive material. DOT and NRC are jointly preparing guidance for the shipment of LSA and SCO materials. DOT is preparing guidance for the implementation of the RPP requirements.

In this presentation the concerns with respect to the RPP requirements will be discussed. This is of particular interest because some transporters have decided, on the basis of the RPP requirements as they stand, to no longer carry radioactive materials, or to no longer carry less-than-full-truckload amounts. There will also be a brief discussion of some of the other changes in the DOT regulations.

INTRODUCTION

On September 28, 1995, the Research and Special Programs Administration (RSPA) of the U. S. Department of Transportation (DOT) published a final rule (1) in the Federal Register under Docket No. HM-169A. This final rule introduced changes to those sections of Parts 171 through 178 of Title 49 of the Code of Federal Regulations (49 CFR 171 - 178) which pertain to the transportation of radioactive materials. These changes were made in order to bring the DOT regulations for radioactive material transport more closely into conformance with International Atomic Energy Agency (IAEA) regulations published in Safety Series No. 6, 1985 (as amended 1990). (2) This was important in order to promote consistency in requirements for international shipments, since the international regulations had already been adopted, in more or less faithful form, by most of the other major nuclear nations. The effective date of the DOT changes was April 1, 1996, with the exception of the Radiation Protection Program (RPP) requirements, for which the effective date is October 1, 1997. The DOT changes were published in coordination with the U. S. Nuclear Regulatory Commission (NRC), which published the new revision of 10 CFR 71 on the same date, with the same effective date. (3)

Among those amendments which may impact the waste management community are changes in A1 and A2 values, changes in shipping paper, marking and labeling requirements, the use of SI units, and the elimination of Fissile Classes. Changes having a potentially significant impact are the introduction of industrial packagings, the addition of Surface Contaminated Objects (SCO) as an option for shipping some objects previously classified as Low Specific Activity material (LSA), the introduction of LSA and SCO categories, and the RPP requirements for shippers and carriers of radioactive material. DOT and NRC are jointly preparing guidance for the shipment of LSA and SCO materials. DOT is preparing guidance for the implementation of the RPP requirements.

In this presentation the concerns with respect to the RPP requirements will be discussed, and an update will be given on the status of the DOT guidance on the RPP requirements. There will also be a brief discussion of some of the other changes in the DOT regulations.

RADIATION PROTECTION PROGRAM REQUIREMENTS

The RPP requirements are found in Subpart I of 49 CFR 172, sections 172.801, 803, 805, and 807, and implementation paragraphs for the different transportation modes are found in sections 174.705 (rail), 175.706 (air), 176.703 (vessel), and177.827 (highway). They are requirements for developing and maintaining a RPP, and apply to consignors, consignees, and carriers. Mechanisms are provided to allow for exceptions under certain conditions.

If not eligible for an exception, persons covered must develop, implement and maintain a RPP. The RPP must follow ALARA principles, satisfy various effective dose equivalent limits for occupationally exposed hazardous materials (hazmat) workers and members of the public, include monitoring by radiation dosimeters, and be in accordance with U. S. Environmental Protection Agency (EPA) guidance to federal agencies for occupational exposure. Publications No. 59 "Operational Radiation Safety Program (1978)" and No. 116 "Limitation of Exposure to Ionizing Radiation (1993)" of the National Council on Radiation Protection and Measurements (NCRP) are cited as guidance documents which "should" be reviewed and followed.

Written records must be retained of RPP activities, including dosimetry records. A hazmat employer must provide a dose history to an employee within a reasonable time following a request, and no more than three months after the termination of employment. The Associate Administrator for Hazardous Materials Safety (DOT) must be notified in writing if a hazmat employee or a member of the public receives a dose over one of the specified quarterly or annual limits as a result of the hazmat employer's transportation activities.

The RPP requirements are considered to be satisfied by any radiation protection program that has been approved by an appropriate federal or state agency.

It is stated that the RPP requirements do not apply to persons who offer or carry less than 200 TI of packages in a 12-month period, or to those persons whose operations will not result in a hazmat employee receiving an exposure of 5 mSv or more per year. In order to qualify for an exception, the shipper or carrier must provide evidence that one or more of the conditions under which an exception is allowed is in fact satisfied. Presumably those persons who satisfy the 200 TI condition can document this on the basis of a review of shipping papers or a subset of them. The alternate condition, that a hazmat employee will not receive more than 5 mSv in a year, must be the conclusion of a study of the employer's radioactive materials transportation activities for a period of at least 12 months. The study must be conducted by a person experienced with radiation protection programs and transportation regulations and programs.

In either case, an additional condition in order to qualify for an exception is that the employer must develop and keep recordswhich demonstrate why a RPP is not required. Furthermore, it is implied that this justification should be reasonably up-to-date, since reference is made to a demonstration that "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."

Background

National requirements for the transportation of radioactive materials have historically been based on, but not identical to, the requirements in the international "regulations" published by the IAEA as Safety Series No. 6, "Regulations for the Safe Transport of Radioactive Material." Safety Series No. 6 is updated periodically, at approximately 10-12 year intervals. These international "regulations" are actually consensus standards, which don't take on the force of law until and unless they are incorporated into the national regulatory structure of individual member countries, such as the U. S.

Various editions of Safety Series No. 6 have contained more or less general statements for limiting the exposure of persons to radiation resulting from the transport of radioactive materials. These statements include the requirement for "periodic assessments" to be carried out to ensure that maximum exposure levels are not being exceeded, that radiation surveys be taken when there is reason to suppose that these levels are being approached, and that workers involved in transporting radioactive materials receive appropriate training.

More specific requirements for protection of transport workers and members of the public from radiation received as a result of transportation activities were published in Reference 2, paragraphs 201 through 205. Reference is made to the requirements specified in IAEA Safety Series No. 9, "Basic Safety Standards for Radiation Protection, 1982 Edition," which is based on Publication 26 of the International Commission on Radiological Protection. Here for the first time the concept of "as low as reasonably achievable" (ALARA) is introduced, a three-tiered system for controlling the dose to occupationally exposed transportation workers is proposed, and annual doses of 5 mSv for transport workers and 1 mSv for members of the public are proposed for purposes of calculating segregation distances or dose rates in regularly occupied areas.

On November 14, 1989, a Notice of Proposed Rule (NPRM) for Docket No. HM-169A was published in the Federal Register. (4) The requirement for a RPP was placed at that time in section 173.405, and essentially proposed the three-tiered system contained in Safety Series No. 6, plus various dose limits for members of the public. Several persons and organizations, in their responses to the NPRM, commented on the difficulty for carriers to determine which tier they are in. Further, several of the commenters suggested that the determination as to whether a RPP is necessary should be related to the total Transport Index (TI), since this is the only information usually available to carrier personnel.

As a result, the final rule contains no reference to the three-tiered system. Instead, an attempt was made to provide the opportunity for an exception based solely on TI, or, as an alternative, on an evaluation leading to the conclusion that no hazmat employee would receive 5 mSv or more per year.

Request for Comments

During the months which followed publication of the final rule, several persons commented verbally to members of the DOT staff that they were having difficulties with the RPP requirements. Consequently on April 29, 1996, DOT/RSPA published in the Federal Register (5) a request for comments on the implementation of the RPP requirements. With the request for comments it was also stated that RSPA is developing guidance for the radioactive material industry to facilitate compliance with those requirements.

Twenty five written comments were received, as well as three petitions for reconsideration and one petition for rulemaking.

General conclusions from the comments received are:

  1. Most shippers and receiving institutions are licensed under NRC regulations, and therefore already operate under a RPP as a condition of their license to use radioactive material. Thus, most of the impact of these requirements falls on the carriers.
  2. Because of the perceived difficulty in applying the new rules, either in demonstrating that a RPP is not needed, or in establishing and maintaining a RPP, several carriers have declared that they will no longer carry radioactive materials. This in turn can cause delays and bottlenecks in deliveries, and/or greatly raise the cost of radioactive material transport.
  3. Several persons argued that a RPP is not needed, because the traditional emphasis on the use of packaging and procedures to minimize dose to workers and the public already works admirably.
  4. The inclusion of the 0.02 mSv/hour limit for radiation exposures to members of the public, without specifying that this requirement is for fixed facilities, has the consequence for highway vehicles that the only way to guarantee compliance is for the driver to erect a barrier around a loaded vehicle, or to station a guard there, every time it is parked.
  5. It was noted that some of the language used is ambiguous, or possibly does not say what was intended. For example, an exception is allowed for "persons who offer for transportation or transport less than 200 TI, not including TI calculated for criticality purposes, of packages in a 12-month period," and it appears open to question as to whether this exception is only for companies whose total TI for the year is 200 or less, or whether it means that an exception is allowed if no single worker handles more than 200 TI in a year.
  6. The statement that "the evaluator's competency may be evidenced by being certified by the American Board of Health Physics ..." is apparently being interpreted by some persons as meaning that the evaluator must be so certified.
  7. Several complaints were received on the 200 TI exception limit. Generally it was felt that it is too small, for various reasons. One person noted that the 0.0045 mSv (0.45 millirem)/TI ratio on which it is based was derived principally from radiopharmaceutical data, which is irrelevant for other types of ground shipments. Others claimed that it is equivalent to allowing the exception only if no worker would receive more than 1 mSv/year, when the annual limit for members of the public in the same regulations is 5 mSv. Still others argued that the ratio is from data that reflects conditions 15 to 20 years ago, and that a similar study done today would result in a smaller ratio, and therefore allow a higher TI threshold.
  8. It was pointed out that the NRC annual limit for members of the public is now 1mSv. Also, the NRC's allowed response times for an employer to answer requests by employees for dose information are different from those listed in these DOT regulations.
  9. Generally, several persons indicated that the requirements as they stand are confusing, and/or too burdensome and costly for smaller carriers to implement.

There were additional comments and questions, but the above list gives an idea of some of the concerns.

Status of Development of Guidance

Milestones for an orderly solution to the questions raised are being developed. Elements which are presently being considered are:

  1. Official postponement of the implementation date, for a period of time adequate to clarify issues, develop and disseminate guidance, and prepare the industry for the changes involved.
  2. Examination of radiation exposure data available from quarterly reports for carriers party to existing DOT exemptions which have RPPs as a condition of their use.
  3. Sponsoring a contract study of annual dose per TI rates for different segments of the radioactive material transport industry.
  4. Development of a guidance document for dealing with the RPP requirement, which will include industry input. This may or may not be accompanied by modifications of the rules, as necessary.

Outline of Proposed Guidance

The proposed guidance, when ready, will be made available in draft form to interested parties for additional comment and possible modification before it is formally published. A general outline of the approach used to develop the guidance is:

  1. The RPP should be required only when needed.
  2. The tests and documentation needed for demonstrating that an RPP is not needed should be as simple as possible.
  3. When an RPP is needed, it should have the minimum complexity needed for the operation in question.
  4. The DOT RPP requirements should be as consistent as possible with, and no more restrictive than, the NRC RPP requirements.
  5. Protection of the workers, and particularly of the public, should be based as much as possible on the passive restraints provided by existing RAM transport regulations.
  6. Common sense should rule; an organization should be given the flexibility to make reasonable professional decisions about who should be monitored.
  7. The rules should be written in as clear a fashion as possible, and clear and comprehensive guidance provided.

Although this outline doesn't lead directly to specific solutions, the philosophy is to minimize the burden so far as possible.

OTHER CHANGES IN THE DOT REGULATIONS

Changes in A1 and A2 values

In the 1985 Edition of Safety Series No. 6, as amended in 1990, a new modeling procedure was used to determine A1 and A2 values, and calculations were performed for additional isotopes not previously considered. The overall result is that most of the A1/A2 values underwent some modification, and values for additional isotopes were included in the list. Since the DOT regulations in this regard have mirrored the IAEA regulations, these changes in A1/A2 values were reflected in the recent amendments to the DOT regulations. The net result is that of 284 entries in 49 CFR 173.435, A1 values increased for 128 cases and decreased for 95 cases, 144 A2 values increased and 73 were reduced, and the other A1/A2 values remained unchanged. Also, 115 new isotopes were added to the list.

A special situation exists with respect to the A2 value for the isotope molybdenum-99. Formerly 0.8 TBq (20 Ci), the new value is 0.5 TBq (13.5 Ci). However, for domestic shipments only, the A2 value for 99Mo is still 0.8 TBq (20 Ci). This exception was made on the basis of cost implications and health and safety arguments by the radiopharmaceutical industry, and because of the excellent safety record for the transportation of 99Mo generators.

Requirements Concerning Shipping Papers, Marking and Labeling

Several minor changes were made in shipping paper requirements. The words "RADIOACTIVE MATERIAL" are no longer required in the shipping description, unless they are part of the proper shipping name. There has been a slight relaxation in the requirement that the shipping paper contain the name of each isotope in the contents listed in 173.435; this is now necessary only for any combination of radioisotopes which accounts for at least 95% of the total hazard, as described in 49 CFR 173.434(f). Activity units are now to be SI units (terabecquerels, gigabecquerels, etc.) with optional use of customary units (Curies, millicuries, etc.) in parentheses, although for domestic shipments, use of customary units only is permitted until April 1, 1997.

Radioactive material packaging which is Type B, Type B(U), or Type B(M) must now be marked with the trefoil symbol, as described in Appendix B to Part 172.

Fissile classes are no longer used and therefore the fissile class is no longer a criterion for determining the appropriate package label. Isotopes which account for at least 95% of the total hazard must be listed on the label, and the activity units used follow the same restrictions listed above for shipping papers.

The Elimination of Fissile Classes

In coordination with the NRC, fissile class designations were eliminated. Instead, the transport index has been redefined to be the larger of the transport index determined by radiation measurements and the one, for fissile materials, determined for the purpose of criticality control. Thus, the transport index is now the primary control for determining the number of fissile packages which may be transported together.

Low Specific Activity Material

LSA was previously defined as satisfying one of several criteria listed in the definitions of 173.403, and provided a means of transporting greater than Type A quantities in less rigorously constructed packages than those needed for more concentrated Type B material. To bring DOT regulations more closely into conformance with international regulations, this definition of LSA was replaced by definitions of categories called LSA-I, LSA-II, and LSA-III. These were determined roughly on the basis of increasing hazard, and intended to correspond to increasingly sturdy industrial packagings, IP-1, IP-2, and IP-3.

Surface Contaminated Objects

In accordance with international regulations, the concept of surface contaminated objects, or SCOs, was introduced, for materials which are not inherently radioactive, but which carry radioactive contamination on their surfaces. Two categories have been defined, SCO-I and SCO-II, in order of increasing contamination. The advantage of the SCO definition is that if the contamination limits are not exceeded, these objects may be transported in industrial packagings; a more highly contaminated object would have to be transported in a Type B package.

Packagings

Limited quantities, instruments and articles meeting appropriate activity and dose rate requirements were previously allowed to be transported in "strong, tight packages so that there will be no leakage of radioactive material under conditions normally incident to transportation." Similarly LSA could be transported in DOT Specification 7A Type A packages, or in strong, tight packages if these were shipped in an exclusive use vehicle. The amended regulations now require that packaging for all such items meet (at least) the general package design requirements of 173.410. These also now include a requirement that the package be able to withstand the effects of certain defined accelerations, vibrations or vibration resonances. A domestic exception was retained for LSA-I materials, so that they may still be transported in DOT Specification 7A Type A packages, or in strong, tight packages if these are transported in an exclusive use vehicle.

The concept of industrial packagings was introduced to provide appropriate packagings for LSA and SCO materials. The primary requirements for industrial packagings are found in 173.411. IP-1 packagings have to meet the general design requirements of 173.410. IP-2 and IP-3 packagings must satisfy these and more stringent requirements.

Packaging requirements for LSA and SCO materials are found in 49 CFR 173.427. Table 8 of that section lists the minimum category of industrial packaging required for each category of LSA or SCO. One of the limitations for the use of industrial packagings is that the external dose rate from the material to be shipped in them must not exceed 10 mSv/h at 3meters from the unshielded material. If this dose rate limit, or the other limitations listed here, cannot be met, the material must be packaged in accordance with 10 CFR 71.

Guidance in the application of the rules for LSA and SCO is being developed jointly by DOT and NRC, and is described in a separate presentation by a representative of the NRC.

SUMMARY

On April 1, 1996, a major revision of U. S. DOT and NRC regulations for the transport of radioactive materials became effective. Most changes were relatively minor. Those with most impact on the waste management community are the introduction of industrial packagings, of Surface Contaminated Objects, and of categories for LSA and SCO. An additional requirement for certain shippers, carriers and receivers to have a Radiation Protection Program does not become effective until October 1, 1997. DOT is developing guidance for these RPP requirements. This guidance is intended to make implementation of the requirements as easy and reasonable as possible.

REFERENCES

  1. Federal Register, Vol. 60, No.188, September 28, 1995, pp. 50292-50336, "49 CFR Part 171, et al: Hazardous Materials, Transportation Regulations; Compatibility with Regulations of the International Atomic Energy Agency; Final Rule." See also Federal Register, Vol. 61, No. 90, May 8, 1996, pp. 20747-20753, "49 CFR Parts 172, 173, 174, and 176: Hazardous Materials, Transportation Regulations; Compatibility with Regulations of the International Atomic Energy Agency," for editorial revisions of the final rule.
  2. Safety Series No. 6, Regulations for the Safe Transport of Radioactive Material, 1985 Edition (As Amended 1990), International Atomic Energy Agency, Vienna, 1990.
  3. Federal Register, Vol. 60, No. 188, September 28, 1995, pp. 50248-50289, "10 CFR 71: Compatibility With the International Atomic Energy Agency (IAEA); Final Rule."
  4. Federal Register, Vol. 54, No. 218, November 14, 1989, pp. 47454-47490, "49 CFR Part 171 et al: Hazardous Materials, Transportation Regulations; Compatibility with Regulations of the International Atomic Energy Agency; Notice of Proposed Rule."
  5. Federal Register, Vol. 61, No. 77, April 19, 1996, p. 17349, "Guidance for Radiation Protection Programs; Request for Comments."