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

DEPARTMENT OF TRANSPORTATION

Research and Special Programs Administration

49 CFR Parts 171, 172, 173, 174, 175, 176, 177 and 178

[Docket No. RSPA-99-6283 (HM-230)]

RIN 2137-AD40

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

AGENCY:

Research and Special Programs Administration (RSPA), DOT.

ACTION:

Final rule.

SUMMARY:

In this final rule RSPA is amending requirements in the Hazardous Materials Regulations (HMR) pertaining to the transportation of radioactive materials based on changes contained in the International Atomic Energy Agency (IAEA) publication, entitled “IAEA Safety Standards Series: Regulations for the Safe Transport of Radioactive Material,” 1996 Edition, No. TS-R-1. The purpose of this rulemaking initiative is to harmonize requirements of the HMR with international standards for radioactive materials as well as to promulgate other DOT-initiated requirements.

DATES:

Effective Date:

The effective date of these amendments is October 1, 2004.

Voluntary Compliance Date:

RSPA is authorizing voluntary compliance with the amendments adopted in this final rule beginning February 25, 2004. However, RSPA may further revise this rule as a result of appeals it may receive for this rule.

Incorporation by Reference Date:

The incorporation by reference of publications listed in this final rule has been approved by the Director of the Federal Register as of October 1, 2004.

FOR FURTHER INFORMATION CONTACT:

Dr. Fred D. Ferate II, Office of Hazardous Materials Technology, (202) 366-4545, or Charles E. Betts, Office of Hazardous Materials Standards, (202) 366-8553; RSPA, U.S. Department of Transportation, 400 Seventh Street SW., Washington, DC 20590-0001.

SUPPLEMENTARY INFORMATION:

Contents

I. Background

II. Overview of Changes in this Final Rule

A. Summary of Amendments

B. Issue Discussion

Issue 1: Nuclide-Specific Exemption Values

Issue 2: Naturally Occurring Radioactive Materials

Issue 3: Changes in A

1

and A

2

Values

Issue 4: Communication Changes

Issue 5: Low Specific Activity (LSA) materials and Surface Contaminated Objects (SCO)

Issue 6: Uranium Hexafluoride (UF

6

)

Issue 7: Air Transport Requirements

Issue 8: Fissile Material Package and Transport Requirements

Issue 9: Transitional Requirements

Issue 10: Other Changes

III. Section-By-Section Review

IV. Regulatory Analyses and Notices

A. Executive Order 12866 and DOT Regulatory Policies and Procedures

B. Executive Order 13132

C. Executive Order 13175

D. Regulatory Flexibility Act, Executive Order 13272, and DOT Regulatory Policies and Procedures

E. Paperwork Reduction Act

F. Regulation Identifier Number (RIN)

G. Unfunded Mandates Reform Act

H. Environmental Assessment

I. Privacy Act

I. Background

In 1958, at the request of the Economic and Social Council of the United Nations, the IAEA undertook the development of international regulations for the safe transportation of radioactive materials. The initial regulations published by the IAEA in 1961 were recommended to member states as the basis for national regulations and for application to international transportation. Most nations have since adopted the IAEA regulations as a basis for regulations governing the transportation of radioactive materials.

In 1967, after extensive revisions, the IAEA published its regulations entitled “Regulations for the Safe Transport of Radioactive Material, Safety Series No. 6.” In October 1968, DOT published amendments to the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) for radioactive materials which were in substantial conformance with the 1967 IAEA regulations (Docket HM-2, 33 FR 14918).

Based on work done by participants from member states, including the U.S., the IAEA issued two major updates of Safety Series No. 6 in 1973 and 1985. On March 10, 1983, the Research and Special Programs Administration (RSPA, we) published a final rule (Docket HM-169, 48 FR 10218), bringing the HMR requirements relating to the transportation of radioactive materials into alignment with the 1973 IAEA regulations. On September 28, 1995, we published a final rule (Docket HM-169A, 60 FR 50291) that revised the radioactive materials requirements in the HMR to align them with the 1985 revision of Safety Series No. 6. In each case, we coordinated the HMR revisions with the Nuclear Regulatory Commission (NRC), which concurrently revised 10 CFR part 71, and in each case these revisions made the United States radioactive material transport regulations compatible with those of most other industrialized nations.

In 1996, the IAEA revised and issued IAEA Safety Standards Series No. ST-1, (“ST-1”). IAEA subsequently revised ST-1 in June 2000 to include minor editorial changes and renamed it “TS-R-1.” In this final rule, we use the nomenclature “TS-R-1” to refer to the 1996 IAEA “Regulations for the Safe Transport of Radioactive Material.” Copies of TS-R-1 may be obtained from the U.S. distributor, Bernan Associates, 4611-F Assembly Drive, Lanham, MD 20706-4391, telephone (301) 459-7666.

As in past rulemakings to incorporate updates of the international regulations into the HMR, we are working in close cooperation with NRC in the development of this rulemaking. Currently, DOT and NRC jointly regulate the transportation of radioactive material in the United States in accordance with a July 2, 1979, Memorandum of Understanding (MOU; 44 FR 38690). In accordance with this MOU (a copy of which has been placed in the docket of this rulemaking):

1. DOT regulates both shippers and carriers and has issued:

• Packaging requirements;

• Communication requirements for:

—Shipping paper contents,

—Package labeling and marking requirements, and

—Vehicle placarding requirements;

• Training and emergency response requirements; and

• Highway routing requirements.

2. NRC requires its licensees to satisfy requirements to protect public health and safety and to assure the common defense and security, and:

• Certifies Type B and fissile material package designs and approves package quality assurance programs for its licensees;

• Provides technical support to DOT and works with DOT to ensure consistency with respect to the transportation of radioactive materials; and

• Conducts inspections of licensees in accordance with DOT requirements.

This rulemaking is being coordinated by RSPA with NRC to ensure that consistent regulatory standards are maintained for radioactive material transportation regulations, and to ensure coordinated publication of rules by both agencies. This final rule addresses only the areas over which DOT has jurisdiction as defined in the MOU. Comments received on non-DOT issues

or on DOT issues not in the scope of this rulemaking will not be addressed in this rule.

On December 28, 1999 (64 FR 72633), we published an advance notice of proposed rulemaking (ANPRM) requesting comments from interested persons concerning the extent to which differences between the HMR and the IAEA publication TS-R-1 should be considered in proposing changes to the HMR. We identified a partial list of TS-R-1 requirements being considered for incorporation in the HMR. We invited interested persons to review and comment on any or all of the requirements in TS-R-1 that differ from current HMR requirements and identify related issues we should address in the NPRM. In response to the ANPRM, we received approximately 80 written comments from trade associations, hazardous materials consulting firms, chemical manufacturers, radiopharmaceutical manufacturers, shippers and carriers of hazardous materials, and private citizens.

In addition, we compared TS-R-1 to the previous version of Safety Series No. 6 to identify changes made in TS-R-1, and then identified affected sections of the HMR. Based on this comparison and comments received from the ANPRM, we identified ten issues where increased compatibility between the HMR and TS-R-1 appears to be desirable.

On February 1, 2000, we published a final rule under Docket HM-215D (66 FR 8644), in which we adopted the International Maritime Dangerous Goods (IMDG) Code, 2000 edition, including Amendment 30-00 and the UN Recommendations on the Transport of Dangerous Goods, Eleventh Revised Edition (1999), both of which authorize the use of TS-R-1. We published a final rule on June 21, 2001 (66 FR 33315), which provided that TS-R-1 could be used, as an alternative to the HMR, for international shipments of radioactive materials. Additionally, we retained Safety Series No. 6 with the same restrictions.

This final rule will address the adoption of TS-R-1 (instead of Safety Series No. 6) requirements into the HMR for domestic use. On April 30, 2002, we published a notice of proposed rulemaking (NPRM) under Docket HM-230 (67 FR 21328). The major changes to the HMR proposed in the NPRM included the following:

(1) Adopt the nuclide-specific exemption activity concentrations and the nuclide-specific exemption consignment activities listed in TS-R-1 to assure continued consistency between domestic and international regulations for the basic definition of radioactive material;

(2) Adopt the new proper shipping names and UN identification numbers, except for those referring to Type C packages, to fissile low specific activity (LSA) materials or to fissile surface contaminated objects (SCO);

(3) Require, if customary units are to be used, that the appropriate quantity and customary units be placed within parentheses positioned after the original quantity expressed in the International System of Units (SI units);

(4) Incorporate the TS-R-1 changes for packagings containing more than 0.1 kg of UF

6

;

(5) Authorize the use of the 1993 edition of International Organization for Standardization (ISO) 7195 as an alternative to American National Standards Institute (ANSI) N14.1, to require UF

6

packagings to meet the pressure, drop and thermal test requirements, to prohibit the use of pressure relief devices, and to certify the packagings in accordance with TS-R-1 requirements;

(6) Accept the IAEA transitional requirements and begin the phase-out of packages satisfying the 1967 IAEA requirements, including DOT specification packages; and

(7) Require that manufacture of all Type B specification packages conforming to Safety Series No. 6 (1967) be prohibited as of the date of implementation of this rule and that use of these packages be prohibited two years after implementation of this rule.

Those proposed changes were intended to harmonize requirements of the HMR with international standards for the transport of radioactive materials as well as to promulgate other DOT initiated requirements.

More than 150 commenters submitted over 200 comments in response to the NPRM, including representatives of Federal and state agencies, manufacturers, shippers, carriers, consultants, electric utilities, special interest groups, private citizens and trade associations.

II. Overview of Changes in This Final Rule

A. Summary of Amendments

In this final rule, we are amending the HMR to:

• Adopt the nuclide-specific exemption activity concentrations and the nuclide-specific exemption consignment activities listed in TS-R-1 to assure continued consistency between domestic and international regulations for the basic definition of radioactive material;

• Provide an exception in the HMR that certain naturally occurring radioactive materials would not be subject to the requirements of the HMR so long as their specific activities do not exceed 10 times the activity concentration exemption values;

• Incorporate the TS-R-1 changes in the A

1

and A

2

values into the HMR;

• Adopt the new proper shipping names and UN identification numbers, except for those referring to Type C packages, to fissile LSA material and to fissile SCOs;

• Require, if customary units are used, that the appropriate quantity and customary units be placed within parentheses positioned after the original quantity expressed in the International System of Units (SI units);

• Adopt the use of the Criticality Safety Index (CSI) to refer to what was formerly the criticality control transport index, and to restrict the use of the concept of transport index (TI) to a number derived purely from the maximum radiation level at one meter from the package;

• Require the new fissile label be placed on each fissile material package, and that the CSI for that package be noted on the fissile label;

• Adopt the requirement that excepted packages be marked with the UN identification number, that industrial packagings be marked with the package type, and that Type IP-2 and IP-3 industrial packages and Type A packages be marked with the international vehicle registration code of the country of origin of packaging design;

• Remove some former requirements which would become redundant upon adoption of the new proper shipping names, such as the requirement that the shipping description contain the words “Radioactive Material” unless those words are included in the proper shipping name;

• Remove plutonium-238 from the definition of fissile material. Remove the reference to Pu-238 in the list of fissile radionuclides for which the weight in grams or kilograms may be listed instead of or in addition to the activity, in the shipping paper or radioactive label description of the radioactive contents of a package;

• Adopt a definition of contamination, and include an authority to transport unpackaged LSA material and SCO, and an authority to use qualified tank containers, freight containers and metal intermediate bulk containers as industrial packagings, types 2 and 3 (IP-2 and IP-3);

• Adopt the new class of LSA-I material, consisting of radioactive

material in which the activity is distributed throughout and the estimated average specific activity does not exceed 30 times the activity concentration exemption level, and to remove the present category referring to mill tailings, contaminated earth, concrete, rubble, other debris, and activated material that is essentially uniformly distributed, with specific activity not exceeding 10

−

6

A

2

/g.

• Incorporate the TS-R-1 changes for packagings containing more than 0.1 kg of uranium hexafluoride (UF

6

);

• Require UF

6

packagings to meet the pressure, drop and thermal test requirements, to prohibit the use of pressure relief devices, and to certify the packagings in accordance with TS-R-1 requirements;

• Revise § 173.453 to reflect the NRC “fissile material exemption provisions,” to remove the definition of “fissile material, controlled shipment,” and to revise §§ 173.457 and 173.459 to remove the references to “fissile material, controlled shipment” and to base requirements for non-exclusive use and exclusive use shipments of fissile material packages on TS-R-1 package and conveyance CSI limits;

• Accept the IAEA transitional requirements and begin the phase out of packages satisfying the 1967 IAEA requirements, including DOT specification packages;

• Prohibit the manufacture of all Type B specification packages conforming to Safety Series No. 6 (1967) as of the effective date of this rule. The use of these packages would be allowed for three years after the effective date of this rule; and

• Add a requirement that the active material in an instrument or article intended to be transported in an excepted package be completely enclosed by the non-active components.

B. Issue Discussion

Issue 1: Nuclide-Specific Exemption Values

Background.

In the April 30, 2002 NPRM, we proposed to adopt the nuclide-specific exemption activity concentrations and the nuclide-specific exemption consignment activities listed in TS-R-1. The objective of the proposal was to assure continued consistency between domestic and international regulations for the basic definition of Class 7 radioactive material,

i.e.

, of radioactive material which is deemed hazardous enough to be subject to the HMR.

The new exemption activity values would replace the previous activity concentration threshold of 70 becquerels per gram (2000 picocuries per gram)(70 Bq/g (2000 pCi/g)) that has long been used to decide whether a particular radioactive material is regulated by the HMR (

i.e.

, to decide whether it is “radioactive for the purposes of transport”) the proposed exemption values include. This is in contrast to the previous use of a single threshold defined in terms of an activity concentration. In addition to nuclide-specific activity concentration thresholds proposed, nuclide-specific consignment activity thresholds such that consignments with activities below the latter thresholds would also not be considered “radioactive for the purposes of transport.”

The considerations which led to the establishment of the exemption values, and the sources from which that information was obtained, are described in the NPRM. They included calculations carried out during the development of TS-R-1, involving 20 radionuclides, which represent radionuclides actually transported, to calculate the activity concentrations and the consignment activities that would not give an annual dose to transport workers of more than 0.01 millisievert (1.0 millirem), or 0.01 mSv (1.0 mrem) during a variety of transportation scenarios. This was done for each of the 20 radionuclides by determining for each of the approximately 24 scenarios (the number of scenarios varied somewhat, depending on the physical form of the radionuclide) the activity concentration and total activity that would yield an annual dose of 0.01 mSv (1.0 mrem), and then selecting the lowest of those activity concentrations and the lowest of those activities as the exemption values for that radionuclide. These activity concentrations and consignment activities were then compared with threshold activity concentrations and threshold activities that had previously been adopted for fixed facilities as a key element in the “International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources,” Safety Series No. 115, International Atomic Energy Agency, Vienna, 1996.

The IAEA's Standing Advisory Group on the Safe Transport of Radioactive Materials (SAGSTRAM, made up of representatives of a subset of IAEA member countries) had previously agreed that exemption values for transport different from those for fixed facilities would be adopted only if they were different by more than two orders of magnitude, so that to the extent possible, entities dealing with radioactive materials would not have to deal with two different sets of exemption (threshold) values.

The IAEA working groups decided to adopt the exemption values previously adopted in Safety Series No. 115 for fixed facilities because the exemption values calculated for the 20 radionuclides using the transport scenarios did not differ by more than two orders of magnitude. This finding was true for all radionuclides (except Kr-85, a noble gas, for which it was argued that because Kr-85 is not transported in such large containers as used in the scenarios, the scenarios used were overly conservative). For those radionuclides in the transport regulations not listed in Safety Series No. 115, transport exemption values were calculated using the Safety Series No. 115 methodology.

Using the Safety Series No. 115 exemption activity concentrations and the same transport scenarios, those performing the study calculated the annual worker dose averaged over the 20 previously examined radionuclides to be about 0.23 mSv (23 mrem). This compares with an average annual worker dose of about 0.50 mSv (50 mrem) if the same 20 radionuclides had been transported with an activity concentration of 70 becquerels/gram using the same transport scenarios.

In this final rule we are incorporating in the HMR the TS-R-1 nuclide-specific exemption values to specify when radioactive material is regulated as Class 7. According to this new definition, a radioactive material offered for transport is regulated as a Class 7 hazardous material only if both the activity concentration and the consignment activity are greater than the exemption values determined for that material.

Discussion.

One commenter noted that the nuclide-specific exemption values, which are more closely dose related than a strictly activity-based system, are more defensible.

To assist the regulated community in correctly performing these calculations and for consistency another commenter requested that RSPA provide example calculations of the use of the various mixture formulas within the NPRM. To resolve doubts on how to apply the formulas for a specific scenario, any person may obtain help through one of the mechanisms described in § 105.20.

One commenter felt that the proposed changes in the exemption activity concentrations, and particularly the proposed default exemption values, do not appear to represent risk- or performance-based approaches and could negatively impact the overall safety of DOE activities. We believe that the proposed changes in the exemption

activity concentrations do result in a risk-based approach since the dose equivalent received by a person is much more directly related to the risk than is the activity. Adherence to the criterion of limiting annual worker doses to 0.01 mSv (1.0 mrem) was balanced against the cost and safety implications of having to deal with two sets of exemption values, one for fixed facilities and another for transport. As a result of deciding to use the single set of exemption values derived for fixed facilities, the calculated dose and therefore the risk, was reduced by approximately a factor of two.

It is true that the exemption activity concentrations for most of the more commonly occurring alpha emitters have gone down from 70 Bq/g to 10 Bq/g or 1 Bq/g. In several of these cases, such as U(nat), Th(nat), or Ra-226, the number refers to the maximum activity concentration of the parent nuclide in the decay chain (assumed to be in secular equilibrium). Taking into account the activity concentrations of the progeny, the actual activity concentration thresholds for materials with these radionuclides will be higher.

With respect to the proposed default exemption values, paragraph 406.1 of IAEA Safety Guide TS-G-1.1 (ST-2), Advisory Material for the IAEA Regulations for the Safe Transport of Radioactive Material, IAEA, Vienna, 2002, indicates that the default values are the lowest possible values within the alpha or beta/gamma subgroups. In the case of the default activity concentration threshold of 1 × 10

−

1

Bq/g for alpha emitters and for the case when no relevant data are available, the only nuclide in TS-R-1 Table I which has an exemption activity concentration this low is Ac-227. If any person has reason to believe through process knowledge or other means that Ac-227 is not present, or if an upper bound can be placed on the fraction of total activity concentration which may be due to Ac-227, the next lowest alpha emitter exemption activity concentration of 1 × 10

0

Bq/g be used as the default value.

Several commenters recommended that we retain the threshold activity concentration of 70 Bq/g for domestic shipments. One of these commenters argued that the proposed change in the activity concentration exemption values would add significant delays and costs for Department of Energy waste site remediation efforts. The commenter cited past shipments of 98 railcars of soil from the DOE Savannah River Site that were shipped as non-radioactive for purposes of transport because the specific activity of the soil was less than 70 Bq/g, as determined by periodic gross alpha and gross beta measurements. The commenter stated that “under the proposed regulations, the gross measurements would not provide sufficient confidence in the classification and some isotopic analyses [which would then be required] would require significant time to complete. Performing similar removal actions under the proposed regulations will result in delays and costs for isotopic analysis/confirmation as well as additional costs associated with shipping the material as Class 7. This additional time and expense will be incurred with no significant change in the risk presented by such shipments made in compliance with the current regulations.”

Just as gross alpha and beta measurements may not be sufficient with the new exemption values to determine whether the hazardous materials transport regulations apply, this has also been true in the past when determining whether the activity concentration was below 70 Bq/g. Gross counting measurements cannot yield the activity present until the isotopes and types of radiation, as well as the fractions of the counts caused by each isotope, are known. In cases where one or a few radionuclides are present, this information may be known through “process knowledge” or previous measurements, or both. If there are multiple isotopes present it is often not possible to determine this information without doing more lengthy and costly isotopic analyses.

In borderline cases, where some batches of a radioactive material have specific activities that exceed the exemption values and others do not, it may be simpler to determine whether any of the material exceeds the LSA-I limits. If not, the material could be treated conservatively and shipped as LSA-I. Although the material would now be transported under the HMR, the existing regulations for domestic shipments of LSA-I contain relatively modest communication and packaging requirements.

One commenter supported the proposal to adopt the radionuclide-specific exemption values. The commenter noted that of 2400 intermodal containers of decommissioning soil and debris shipped over a 38 month period, all would have had to be shipped as LSA rather than 10% of them, but that the additional cost would have been minimal.

One commenter objected to the nuclide-specific exemption activity concentrations because some of them are higher than the previous 70 Bq/g value. As pointed out in the NPRM, the hazards associated with radioactive materials are not directly related to their activity or activity concentration, but rather to the dose that a person in the vicinity or in contact with them would receive. The new system would, under the reasonable transport scenarios considered, raise the calculated dose due to some radionuclides from a small value to a somewhat larger, but still small value, while lowering the calculated dose from higher values for other radionuclides. For the 20 representative radionuclides for which detailed calculations were performed, the average calculated annual dose to workers transporting these materials at the proposed exemption activity concentration levels would be reduced from about 0.5 mSv (50 mrem) to about 0.23 mSv (23 mrem),

i.e.,

a reduction in dose of about 50%. Members of the public who were not actually involved in transporting these materials would presumably receive much lower doses, if any.

The commenter stated that although the proposed revision cuts the average modeled dose in half, the dose is still much too high. As pointed out above, the decision to use the Safety Series No. 115 exemption values instead of ones calculated specifically for transport, avoided the requirement to use two different sets of exemption values, one for fixed facilities (at least in the countries where these are used, for example most of the European countries) and one for transport. This in itself would likely lead to confusion and more errors, reducing safety.

We note that present NRC limits for occupational dose and dose to members of the public due to licensed activities are 50 mSv (5000 mrem) and 1.0 mSv (100 mrem), respectively. This is in addition to background radiation to which we are all exposed. The average background dose to a person living in the United States, according to information in NCRP Report No. 93, “Ionizing Radiation Exposure of the Population of the United States,” published by the U. S. National Council on Radiation Protection and Measurements in 1987, is approximately 3.6 mSv (360 mrem), of which about 1.0 mSv (100 mrem) is due to cosmic, terrestrial, and internal sources of naturally occurring radiation; about 2.0 mSv (200 mrem) is due to radon; and the remaining 0.6 mSv (60 mrem) is due mostly to medical procedures, with a small contribution from consumer products and miscellaneous sources. Thus the average modeled dose of 0.23 mSv (23 mrem) for dose to workers due to transport of the 20 radionuclides

considered, although not negligible, is small compared to accepted limits and compared to background doses that we all receive. In addition, it is expected that doses from these transport activities to persons not involved in the transport will in almost all cases be much smaller.

A commenter suggested that doses from accidents have not been adequately analyzed. The fact that the average dose for the 20 radionuclides considered diminished by a factor of two indicates that on the average, the proposed exemption values should reduce doses due to accidents involving radioactive materials transported at the exemption levels and using the scenarios chosen.

This commenter noted that the proposed revision of exemption values would create an inconsistency with the present EPA practice of setting an upper limit of 70 Bq/g on the radioactivity content of waste that can be accepted at a Resource Conservation and Recovery Act (RCRA)-regulated waste disposal site. EPA has indicated that it has no national requirement of this type for RCRA Subtitle C facilities, but that such a requirement is frequently dictated by state regulations for the acceptance of mixed waste, or included in the site permit restrictions. The commenter is correct in implying that the proposed replacement of the 70 Bq/g threshold with the new exemption values, for the purpose of regulating the transport of radioactive materials, may result in some waste being sent to the RCRA site in a radioactive material placarded vehicle. However, where this limit is in use, it was obviously based on DOT's definition of radioactive material. If the intent of using this limit is to avoid having the site receive radioactive waste considered radioactive for purposes of transport, either the state regulations or the permit requirements would have to be changed to accommodate the new exemption values.

One commenter supports adoption of the new definition for Class 7 materials. However, the commenter states that the new definition will pose an unreasonable burden to those industries involved in environmental restoration, because classifying low activities in environmental media will be costly and burdensome without benefit. The commenter hopes that RSPA will weigh the effect of each proposed change in light of all affected and adopt domestic exceptions as warranted.

As we indicated above, in this final rule we are adopting the TS-R-1 exemption values to replace the 70 Bq/g criterion for determining when radioactive material will be regulated as a Class 7 hazardous material (with one exception: as discussed under Issue 2, we are also adopting in the HMR the TS-R-1 exception that the Class 7 thresholds will be 10 times the exemption values for ores and other natural materials not intended to be used for their radioactive properties).

With respect to this issue and to the others discussed below, we note that we have reviewed the present regulations, the proposed changes, and the various comments we have received, with the objective of achieving a balance between the competing tasks of ensuring safety and of avoiding imposing unjustified economic burdens on shippers and carriers of radioactive materials. In some cases we believe that domestic exceptions are justified, and have, for example, retained the U.S. practice of only requiring that vehicles carrying category Yellow III packages, highway route controlled quantities or exclusive use shipments of LSA/SCO be placarded, as well as the domestic A

2

value of 0.74 TBq (20 Ci) for Mo-99 and A

1

value of 0.1 TBq (2.7 Ci) for Cf-252.

Issue 2: Naturally Occurring Radioactive Materials

Background.

The radioactive material transport regulations are intended to apply to natural materials or ores that form part of the nuclear fuel cycle, or that will be processed in order to utilize their radioactive properties. They do not apply to other natural materials or ores that may contain small amounts of naturally occurring radionuclides, when those materials or ores are to be used because of some other physical or chemical characteristics, provided that their activity concentration does not exceed 10 times the activity concentration in the table in § 173.436. The regulations also do not apply to natural materials and ores containing naturally occurring radionuclides when these have been subjected to physical or chemical processing, when the processing was not for the purpose of extracting radionuclides, again provided that their activity concentration does not exceed 10 times the activity concentration in the table in § 173.436. Examples of such materials are cement, coal, fertilizers, non-radioactive metals, gypsum, residues from mining and smelting processes, etc. In general these materials present a very low radiological hazard. On the other hand there are ores in nature where the activity concentration is much higher than the exemption values. The factor of 10 times the regulatory exemption activity concentration values was chosen as providing an appropriate balance between radiological protection concerns and the practical inconvenience of regulating large quantities of material with low activity concentrations of naturally occurring radionuclides.

In conjunction with the adoption of the nuclide-specific exemption values, in this final rule we are also incorporating in the HMR an exception for natural materials and ores containing radioactive material, in that natural materials and ores will be regulated as Class 7 hazardous material only if both their activity concentrations and consignment activities are greater than 10 times the corresponding exemption values.

Discussion.

One commenter supports the higher threshold of 10 times the exemption values for natural materials and ores that contain naturally occurring radioactive material but are mined for their non-radioactive components or properties, and states that without an exemption for low levels of naturally occurring radioactive materials, application of the § 173.436 exemption values to these materials would result in unnecessarily regulating enormous amounts of material not currently regulated, and that regulating these materials would provide no benefit and increase their costs to the general public. However, this commenter also states that the intent of using these materials for their radioactive components should not be a determining factor in the risk analysis when they are transported in their natural state, and adds that for whatever purpose the materials are being transported, they pose the same negligible risk. The commenter states that it is only when the materials have been processed and the radioactive components are removed from their natural state that the radioactive components should be considered, and adds that the tailings from the removal of naturally occurring radioactive materials should be included in this group, as well as naturally occurring radioactive materials that accumulate from the extraction of non-radioactive minerals.

Another commenter suggests that DOT and NRC determine if the exemption below 10 times the activity concentration values in the table in § 173.436 would apply to mill tailings and residual radioactivity in soils and debris.

Another commenter indicated that the intended use of a material should not be a factor in how the material should be regulated, and that regulations for the transport of radioactive material should be based only on the radiological properties of the material being shipped.

Still another commenter urges RSPA to clarify in the preamble to the final rule that the “10 times” (“10×”) exemption for “natural materials and ores” includes tailings, secondary materials and solid wastes resulting from non-nuclear processing of such ores. This commenter notes that the need for the shipper to determine the intended end-use of ores creates an artificial and difficult to enforce barrier to the transportation of useful materials, particularly since the eventual end-use is not always known at the time of shipment. In addition, the commenter is not aware of any other instance where DOT applies an “intent” based test when determining whether a material is hazardous.

One commenter recommends that the 10x exemption apply to the domestic transport of unimportant quantities of source material subject to the 10 CFR 40.13 (licensing) exemption provided that the material and ores not be processed for recovery of source material content.

Our intention is that use of the exemption between 1 and 10 times the activity concentration values in the table in § 173.436 be allowed for ores containing small amounts of activity when these ores are not intended to be used for their radioactive properties.

Although in most cases it will be obvious why a certain ore is being mined, we agree that there may be instances where the “intended use” test can be difficult to apply, and that it would be preferable to minimize this burden on the shipper and carrier. We also agree that the intended use of an ore containing low levels of naturally occurring radionuclides does not change the low degree of risk it would present in transport.

In determining if an ore or other material satisfies the 10× exemption criterion, one should avoid using an average activity concentration which masks volumes with much higher specific activities. We suggest that a reasonable criterion for applying the 10× exemption is to determine the “estimated average activity” of the ore or material as described in section 4.2.3 of NUREG-1608/RSPA Advisory Guidance 97-005 for “distributed throughout.” For example, if the material can be divided into 10 or more equal volumes, each no greater than 0.1 m

3

, and the specific activity differences between all pairs of volumes do not vary by more than a factor of 10, then one may average over the specific activities of all the volumes to obtain the estimated average activity, which may then be compared with 10 times the exemption activity concentration obtained from the table in § 173.436. If there are individual differences in the volume specific activities greater than a factor of 10, start with the volume with the maximum specific activity and average that specific activity with the next nine values in order of decreasing magnitude. If this average is no greater than 10 times the activity concentration from the table, the material qualifies for the 10× exemption.

Issue 3: Changes in A

1

and A

2

Values

Background

. A

1

and A

2

values are used in the international and domestic transportation regulations to specify the amount of radioactive material that is permitted to be transported in a particular packaging, and for other purposes. A

1

and A

2

values for the most commonly transported radionuclides are listed in § 173.435 of the HMR, and in Appendix A to 10 CFR 71.

A

1

and A

2

values for most of the commonly transported radionuclides were provided in the 1973 IAEA Safety Series No. 6, and were based on certain dosimetric models and the assumption of certain exposure scenarios and pathways. These models and scenarios were extended and improved in the 1985 Safety Series No. 6, where the calculation procedure was called the “Q system.” This resulted in changes in the A

1

and A

2

values listed there. More recent biokinetic data and dosimetric models have been used to update the Q system and the resulting A

1

and A

2

values in the 1996 TS-R-1. A description of the Q system as applied in deriving the values adopted in TS-R-1 may be found in Appendix I of the IAEA publication TS-G-1.1, “Advisory Material for the IAEA Regulations for the Safe Transport of Radioactive Material,” IAEA, Vienna, 2002.

Based on the results from the updated Q system, IAEA has adopted new A

1

and A

2

values for radionuclides listed in TS-R-1 (see paragraph 201 and Table 1 of TS-R-1). IAEA adopted these new values based on calculations that were performed using the latest dosimetric models recommended by the International Commission on Radiological Protection (ICRP) in Publication 60, “1990 Recommendations of the ICRP.” A thorough review of the Q system also included incorporation of data from updated metabolic uptake studies. In addition, several refinements were introduced in the calculation of contributions to the effective dose from each of the pathways considered. The pathways themselves are the same ones considered in the 1985 version of the Q system (

i.e.

, external photon dose; external beta dose; inhalation dose; skin and ingestion dose from contamination; and dose from submersion in gaseous radionuclides). The impact of these analyses is that for each radionuclide a thorough up-to-date radiological assessment has been performed of potential exposures to an individual should a Type A transport package of radioactive material be involved in an accident during transport. The new A

1

and A

2

values reflect that assessment.

The revised dosimetric models are accepted internationally as more accurate ways of calculating the doses from individual nuclides, and this improvement in accuracy and the additional refinements in the pathways calculations result in various changes to the A

1

and A

2

values.

Discussion

. Several commenters to the ANPRM requested retention of the present A

2

value of 20 Ci for domestic shipments of Mo-99, citing an increase in the needed number of shipments with consequent greater radiation exposure to workers and greater costs as probable consequences of eliminating the present 20 Ci domestic exception.

Two commenters to the ANPRM objected to the TS-R-1 reduction of the A

1

value for californium-252 (Cf-252) from its present value of 0.1 TBq (2.7 Ci) to 0.05 TBq (1.35 Ci), on the basis of very high costs for disposal of present Type A packages for transporting 0.1 TBq of special form Cf-252 and possible development of replacement Type B packages, or of greater radiation exposure to workers because of the need to double the number of shipments if smaller quantities had to be shipped to be able to continue to use existing Type A packagings. However, during analysis of comments to the ANPRM, RSPA and NRC staff members also learned that the IAEA is proposing, for the 2003 revision of TS-R-1, to change the A

1

and A

2

values in TS-R-1 for Cf-252 back to the values currently in the HMR.

Therefore, as proposed in the NPRM, we are adopting the revised A

1

and A

2

values, with two exceptions. We are retaining the A

2

value of 0.74 TBq (20 Ci) for domestic shipments of molybdenum-99 and the A

1

value of 0.1 TBq (2.7 Ci) and A

2

value of 0.001 TBq (0.027 Ci) for domestic shipments of californium-252. Transportation of these isotopes in accordance with international requirements would be subject to the TS-R-1 A

1

and A

2

values.

Some radionuclides for which A

1

and A

2

values are presently listed in § 173.435 and Appendix A of 10 CFR 71 do not appear in Table I of TS-R-1. These are Ar-42, Au-96, Es-253, Es-254, Es-254m, Es-255, Fm-255, Fm-257, Ho-163, Ir-193m, Nb-92m, Po-208, Po-209, Re-183, Te-118, and Tm-168. All except

the Einsteinium (Es) and Fermium (Fm) isotopes appear in Safety Series No. 6, 1985 Edition; the latter (Es and Fm) isotopes were appended to the tables in DOT's and NRC's domestic regulations when these incorporated the 1985 IAEA regulations. Through an oversight, numerical A

1

and A

2

values were never entered for Es-255. The above nuclides were not included in TS-R-1 Table I because of uncertainties in their decay schemes and/or the biological models used to determine doses from internal exposures (Dr. K. Eckerman, Oak Ridge National Laboratory). For this reason, we are removing them from § 173.435. To determine A

1

and A

2

values for these radionuclides we refer the shipper to § 173.433.

Discussion

. Several commenters to the NPRM support the new A

1

and A

2

values.

One commenter noted that the proposed wording for § 173.433(b) did not accurately reflect the TS-R-1 requirements, in that the proposed text did not make it clear that the use of an A

2

value related to the solubility class of the radionuclide, when that A

2

value is not in the table, still requires the approval of the Associate Administrator for Hazardous Materials Safety and, for international shipments, multilateral approval. We agree, and have changed the text of § 173.433(b) to reflect this.

The same commenter noted that the word “Only” for alpha emitting nuclides in Tables 10A and 10B is unnecessarily restrictive, and should be removed (even though it appears in TS-R-1). We agree, and have removed it. This commenter also felt that reference to Tables 10A and 10B should be made in §§ 173.433(e) and 173.433(f) in the case that the identity of each nuclide is known, but not all of the individual activities are known. We disagree because when one applies the directions given in these two sections, any of the prescribed ways of determining the appropriate basic radionuclide values—from the tables in § 173.435 or § 173.436, from Tables 10A or 10B, or by approval of the AAHMS—is acceptable.

This commenter also asks whether the activity of progeny in radioactive decay chains should be included in the total activity required on shipping papers and Radioactive Yellow II and Yellow III labels. The answer is: The same reasoning that led to the inclusion of footnote (a) of the table in § 173.435 of the NPRM should govern the activities to be included on shipping papers and labels. When A

1

or A

2

values include contributions from daughter nuclides with half lives less than 10 days, and no daughter has a half life greater than that of the parent, as referenced in footnote (a) to the table in § 173.435, the parent and those daughters are to be treated as a single radionuclide both for the purpose of using the table to determine the appropriate packaging type, and for the contribution of that chain to the “total activity” required by § 172.203(d) to be included on the shipping paper and by § 172.403(g) to be included on the Radioactive Yellow II and Yellow III labels. The reason is that the A

1

and A

2

values assigned to the parents of those chains have been adjusted to appropriately represent the hazard of all the nuclides in that chain. This will occasionally lead to a situation where the true activity contents of the package can be somewhat greater than the “total” activity listed on the shipping paper and labels. However, the hazard of that decay chain will have been correctly taken into account for the selection of packaging type. The above considerations also imply that in applying the rules for determining which radionuclides should be listed on the shipping paper or labels, the stated daughters in these short half life chains need not be listed, or included in the application of the 95% formula in § 173.433(f).

This commenter also noted that footnote (a) appears in both tables in the NPRM, in §§ 173.435 and 173.436, even though it only refers to A

1

and A

2

values. This was an error, and we have removed that footnote from the table of exemption values in § 173.436, and reordered the remaining footnotes for that table. This commenter also requested the inclusion of an MFP (multiple fission products) entry and an entry for uranium enriched to more than 20% in the A

1

/A

2

table in § 173.435. Multiple fission products should be dealt with by the methods described in § 173.433. A request for approval of A

1

/A

2

values for nuclides not in the table should be addressed to the Associate Administrator, as indicated in § 173.433, with appropriate justification. In general, it is expected that this determination will be made following the guidelines of the Q system, as described in Appendix I to TS-G-1.1.

Issue 4: Communication Changes

Background.

In this final rule we are adopting several changes in the regulations governing hazard communication associated with the transport of Class 7 (radioactive) materials, as well as revising and adding to the definitions in subpart I of 49 CFR 173.

Revisions in hazard communication include the following:

1. We are eliminating entries in the Hazardous Materials Table at § 172.101 presently accompanied by the symbol “D” in column (1) of the Table, and removal of the “I” in column (1) for the remaining Class 7 (radioactive) materials entries.

The “D” symbols, as well as the new proper shipping names and UN identification numbers from TS-R-1 accompanied by the “I” symbols, were introduced for radioactive material entries in the Hazardous Materials Table in the Final Rule for docket HM-215D (66 FR 33316; June 21, 2001). This was done to permit import and export shipments of radioactive materials in accordance with the new international air and sea modal requirements, and to allow shippers to reuse domestically previous imported packagings marked with the new proper shipping names and UN numbers.

As a result of the above action, as of the effective date of this final rule, we will only allow the use of proper shipping names and UN identification numbers established in TS-R-1 and in the international modal regulations. Since we are not adopting domestic use of Type C packages (see Issue 7), we are not incorporating in the HMR proper shipping names and UN identification numbers found in TS-R-1 for Type C packages, or for fissile LSA or SCO materials. In addition, we are not allowing fissile material (above the level considered fissile-excepted) to be transported domestically as LSA material or SCO.

2. We are adopting a requirement to mark UN identification numbers on excepted packages, and to mark package type, international vehicle registration code (the letters USA in the case of the U.S.) on all industrial and Type A packages, and mark the packaging manufacturer on Type A packages.

3. We are specifying that customary activity units (curies, or fractions thereof), if used in shipping paper descriptions or on radioactive labels, must be enclosed in parentheses following the required SI units.

4. We are introducing a criticality safety index (CSI) to express the former criticality control transport index (criticality TI) for fissile material, and the restriction of the term transport index (TI) to the former radiation TI, derived exclusively from the maximum radiation dose rate at one meter from the package. We are also introducing a fissile label for a package of fissile material, on which the CSI for that package must be displayed.

The fissile label will make it obvious that the package is carrying fissile material, and the use of the fissile label in conjunction with the designation of the CSI will reduce the complexity of

the system presently in use. These changes will also simplify decisions as to how many packages can be grouped together, since under the new system the description of radiation and criticality hazards is uncoupled, and during transport each hazard can be considered separately.

5. We are introducing a requirement to mark industrial packagings with the markings TYPE IP-1, TYPE IP-2 or TYPE IP-3.

6. We are removing some former requirements that have become redundant upon adoption of the new proper shipping names, such as the requirement that the shipping description contain the words “Radioactive Material” unless those words are included in the proper shipping name.

7. In accordance with the corresponding change in TS-R-1 (see the discussion for Issue 8), we have removed the isotope plutonium-238 from our definition of fissile material in § 173.403, as well as the reference to it in the list of fissile radionuclides for which the weight in grams or kilograms may be listed instead of or in addition to the activity, in the shipping paper or radioactive label description of the radioactive contents of a package.

8. To improve readability and clarity of the HMR we have moved the labeling requirements for overpacks from § 173.448 to subpart E of part 172.

Discussion.

Three commenters did not support the requirement to mark excepted packages and “empty” packages with the UN number preceded by the letters “UN,” stating this change will not assist first responders in communicating a package's hazard and will more likely than not simply confuse such personnel. The commenters added they were not aware of any situation where a responder was needlessly or excessively exposed to a hazard because, despite its limited quantity, its radioactive nature was not communicated. The commenters did not think that the extra effort to mark Limited Quantity and Empty packages will result in enhanced safety since the quantity of material in these packages has already been determined to be low-risk, and the extra effort to mark these packages is not rewarded with increased safety. We agree that the risk associated with the transport of excepted packages is small; however, in addition to the small benefit for emergency response involving these packages, the benefits of following the same practice for domestic and international regulations in this regard are sufficient to warrant harmonization with TS-R-1.

Two commenters stated that the proposal to modify § 178.350(b) by removing the wording “and Radioactive Material” from the marking requirement is commendable since this wording is already included in the proper shipping name that is also provided as a marking on the package.

One commenter referenced the proposed § 173.427(a)(6)(vi) and stated the existing § 173.427(a)(6)(vi) requires only the stenciling of non-bulk packages with the words “Radioactive-LSA” or “Radioactive-SCO” and “RQ” as appropriate. Typically only non-bulk packages are marked for reportable quantities as per § 172.324. The proposed paragraph no longer states that only non-bulk packages must be stenciled. The commenter recommended ensuring that the intention was to stencil both bulk and non-bulk packages with the words “Radioactive-LSA” or “Radioactive-SCO” and “RQ” as appropriate. We intend that the “Radioactive-LSA” or “Radioactive-SCO”, and “RQ” markings when appropriate, be placed on all Class 7 (radioactive) material packages containing LSA material or SCO, independent of their weight or capacity.

One commenter addressed concerns regarding the proposed change to § 173.424 and the burden that will be imposed upon manufacturers, importers and distributors of consumer products, such as lamps that contain small quantities of radioactive material, if it is adopted as contained in the above referenced docket. The proposed change would modify § 173.424(e) to require the marking “radioactive” on each instrument or article shipped in an excepted package, except for radio-luminescent timepieces. The commenter stated that as is the case with radioactive luminescent timepieces, lighting products, such as lamps, glow-switches or glow bottles that contain small quantities of radioactive material necessary for their operation, are manufactured or imported under either an NRC or Agreement State radioactive materials possession license and distributed (sold) to the general public under an NRC exempt distribution “E” license.

In order for a product to be licensed for exempt distribution, the manufacturer, importer or distributor must satisfy the NRC that it has been manufactured and prototype-tested according to specified standards and that the product meets specified radiation limits, where applicable. In addition, the manufacturer must develop routine quality control testing and production lot sampling procedures to the satisfaction of the agency. According to NRC regulations, a product licensed for exempt distribution may be used and in most cases disposed of by the consumer without regard to its radioactive content. The commenter cited certain other consumer products that will also be affected by this rule change, such as high intensity discharge (HID) lamps and other products which contain thorium.

The commenter argued that to require an NRC-exempt lighting product to be marked as radioactive would be burdensome because “E” licensed lighting products have already been evaluated and licensed for distribution with any marking approved by the NRC. He stated that, in most instances the individual item package, rather than the item itself, is marked with information about the radioactive content; that the new requirement of § 173.424(e) would either supersede or be in addition to the NRC approved product marking; and that the new marking requirement of § 173.424(e) would impose product marking on a large and decade old segment of HID market even though the NRC has found such labeling to be unnecessary. The proposed change to § 173.424(e) would require the product itself to be marked, regardless of size or design, which in some cases could make a readable “radioactive” marking virtually impossible, (

e.g.,

glow switches are sealed glass tubes that measure approximately 20mm long by 9mm in diameter). Individual product marking would entail modifications to production line equipment and possibly even the redesign of certain equipment to accommodate the marking of small components. Marking a lighting product as radioactive would send a mixed message to the consumer, as would be the same marking of a radioactive luminescent timepiece. The NRC has determined that such a product is safe to use without regard to its contained radioactivity and yet § 173.424(e), if enacted as currently written, would require the product to be marked, in the manner of a warning, that it is “radioactive”—a marking the NRC has not deemed necessary.

The commenter also argued that both fluorescent and HID lamps are typically three to four times more energy efficient than incandescent lamps. The Environmental Protection Agency and the Department of Energy actively promote the conversion to more energy efficient lighting, which reduces the amount of coal, oil and gas burned in power plants, as well as the amount of air pollutants including greenhouse gasses released from power plants. A requirement to label these products as radioactive is likely to discourage the

use of these environmentally preferable products. The commenter proposed to change the wording of the instrument or article marking exception to: “* * * (except any device either distributed under a NRC Exempt Distribution License, pursuant to 10 CFR 32.14 or exempt from NRC regulation pursuant to 10 CFR 40.13) * * *”

We agree that in some cases the physical size of the instrument or article that qualifies to be shipped in an excepted package may make it difficult to comply with the requirement to mark “RADIOACTIVE” on such instrument or article. We also agree that the degree of additional safety that this measure would provide is small, while the costs to manufacturers, particularly in the case of items of such small size that they do not easily accommodate the marking, may be unreasonably large, without a commensurate increase in safety. Therefore we are not adopting this proposal. We note, however, that excepted packages of instruments and articles containing small quantities of radioactive material must still have the “RADIOACTIVE” marking if they are to be transported under the IAEA Regulations in TS-R-1, the ICAO Technical Instructions, or the IMDG Code.

A commenter opposed the proposed revision of the requirements pertaining to the labeling of overpacks in § 172.403. Section 172.403(h)(4) in the NPRM, as did its predecessor § 173.448(g)(iv), allows the transport index (TI) of a rigid overpack to be determined by adding the individual indices of the packages inside or by direct measurement of the radiation level at one meter from the outside surface. However, § 172.403(h)(5) in the NPRM states that the label category for an overpack is to be determined by the TI, as determined according to § 172.403(h)(4), and the highest surface radiation level on an individual package inside the overpack, “unless the overpack has been demonstrated to satisfy the packaging requirements for the package type appropriate for the totality of its contents.”

The commenter stated that while the purpose of this change is described by RSPA as a clarification, this will lead to confusion. The proposed requirements could lead to a situation where an overpack may require a Yellow-III category label (because of using the highest surface dose rate on an interior package) yet the measured TI to be entered on the label for the overpack (

e.g.

less than 1.0) could correspond to a Yellow-II or White-I label. Thus this proposed change could result in the need to use a Yellow III label on the overpack when a Yellow II label would be sufficient under present requirements, thereby subjecting the carrier to placarding requirements and additional carrier requirements.

According to the commenter this would place a hardship on shippers who would now have to use placarded vehicles and carriers with Commercial Driver's Licenses (CDLs), yet the Type A packages inside would not be better protected or safer in any way. Any Type A package inside an overpack would still be expected to meet the design and performance requirements on its own, regardless of the type of overpack used. Therefore, if the shipper chooses not to or cannot use the sturdier overpack, which would allow him to use the dose rate on the surface of the overpack to determine the overpack category, more packages, with potentially higher radiation levels than that of the overpack, would then be handled by the shipper, carrier and recipient, resulting in additional radiation exposure to shippers, carriers and recipients of these packages. The commenter stated that this proposal should be abandoned.

Another commenter representing a large maritime construction firm stated that its primary concern is regulations related to transportation of Class 7 (radioactive) materials associated with industrial radiography. Radioactive isotopes, primarily iridium-192 and cobalt-60, are used for soundness inspection of welds and critical components in the submarine construction industry. The proposed requirement, to determine the category of Class 7 label on the overpack based in part on the maximum radiation level on the interior package or packages, would seriously impact his firm and many other industry users that normally transport radioactive materials in order to conduct inspections required by government specifications. Users and small businesses would be adversely impacted through costs associated with compliance with the proposed rules, since in many cases both the overpack and the interior package or packages would now be labeled Yellow-III, and whether or not the overpack is used, the vehicle would require a placard. Since DOT regulations require the driver of any vehicle requiring a placard to possess a CDL and to be a “Registered Shipper of Hazardous Materials,” this would entail additional costs for the businesses involved, with no additional benefit, or even increased radiation exposure if the company decided not to use the overpack. The commenter stated that the proposed requirement would increase the radiation exposure received by workers incident to the transportation of radioactive materials required for industrial radiography as well as other industries, such as those using moisture density gauges, well logging equipment, alloy identification equipment, and other radioactive devices, since if the labels on the packages and also on the overpack are determined by this proposed requirement to be Radioactive Yellow-III, transporters would now have less incentive to use an overpack. The proposed requirements would reduce the use of overpacks and packages would be transported at radiation levels closer to the maximum limits allowed.

Another commenter expressed concern that radiographers and some density gauge users, who under present regulations can use an overpack to reduce the category of label and therefore avoid having to placard their vehicle, would under the proposed change for determining the category of an overpack be forced to placard their trucks, and that the radiographer and gauge users and the general public could be at risk from terrorist or thieves who would be keenly aware of the presence of radioactive devices that have been invisible to them in the past by stalking the hundredfold increase in radioactive placarded vehicles on the roads. He added that even without the events of 9/11, there have been many gauge thefts out of the back of vehicles, and that placing a placard on the back of a vehicle may appear to increase the safety of the public, but it could increase the risk to the radiographers, gauge users and the public since the devices are relatively easy to steal.

We have reviewed the consequences of the wording proposed for § 172.403(h)(5) in the NPRM, and we agree with the above commenters. The requirement to use a sturdier overpack, which could often imply the need for a Type B packaging, in order to be able to use the overpack surface dose rate to determine its category for labeling purposes, is unreasonably restrictive and in many cases impossible to realize. Therefore, we are removing that restriction in § 172.403(h)(5), and simply requiring that, by the procedure described in § 172.403(b) for packages, the category of the overpack be determined using the maximum dose rate on the surface of the overpack, and the TI for the overpack determined by one of the methods prescribed in § 172.403(h)(3) for a non-rigid overpack, or in § 172.403(h)(4) for a rigid overpack.

One commenter agreed with the proposal in § 178.350(b) to remove the wording “Radioactive Material” from the marking requirement on a DOT

Specification 7A Type A package, as this wording is already included in the proper shipping name that must also be marked on the package. This commenter also agreed with the proposal to retain the ability in §§ 172.203(d) and 172.403(g) to use the customary units of activity as long as they are placed within parentheses after the original quantity in SI units. According to this commenter this will facilitate the ongoing understanding of carriers, end users and potential emergency responders who are accustomed to seeing the customary units to describe the contents of radioactive materials packages.

Two commenters stated that customary units should be required if the SI system is used. One commenter stated that customary units should be required and the SI units be optional, but put in parenthesis, if used. Three commenters supported the proposed changes for §§ 172.203(d) and 172.403(g) that would allow continued use of customary activity units as long as they are placed within parentheses after the original quantity in SI units. As noted elsewhere, we are requiring that customary units, if used, be placed after the required SI units, and be enclosed in parentheses. The present regulations allow the shipper to use customary units after the required SI units. In this final rule, we are adding the requirement that these be enclosed in parentheses.

A commenter stated that some place in the proposed regulations the format of the criticality safety index should be specified for appropriate guidance to both shippers and carriers. The following modification was suggested: The CSI for packages containing fissile material is determined in accordance with the instructions provided in 10 CFR 71.22, 71.23 and 71.59, and is a number rounded up to the nearest tenth. It is recognized that the above information is provided in 10 CFR, but the added phrase specifying the numerical format should be included in DOT's regulations. We agree, and have inserted that clarification in our definition of CSI in § 173.403.

One commenter noted that in § 175.702(b)(2), which deals with the requirements for carriage of packages containing Class 7 (radioactive materials) in a non-exclusive use cargo aircraft only, when the total transport index for all the packages is greater than 50.0 but does not exceed 200.0, and the criticality safety index for all of the packages does not exceed 50.0, the proposed section remains incompatible with IAEA TS-R-1, and in fact it is also incompatible with IAEA Safety Series No. 6, (1985 Edition as Amended 1990). The proposal in the NPRM is that the radioactive material packages be in groups not exceeding 50.0 TI and that each group of 50 TI or less is separated from all other groups of 50 TI or less by at least 6 meters and from humans by at least 9 meters.

The commenter noted that the IAEA TS-R-1 Table IX provides for 200 TI on a cargo aircraft. Paragraph 562 of TS-R-1 states that segregation between the radioactive materials and human occupied space shall be governed by paragraph 306, which prescribes annual dose limits for the purpose of calculating segregation distances. Table 7-6 in the 2001-2002 edition of the ICAO Technical Instructions is calculated on such a basis for TI's between 50.0 and 200.0. He stated that the fifty TI grouping should be abolished and the ICAO segregation table should be adopted. Grouping of packages into 50.0 TI or less involves additional handling and therefore represents a dosage increase. The 50.0 to 200.0 TI segregation table has been in ICAO and IATA for many years, ever since the adoption of IAEA Safety Series No. 6 (1985 Edition as Amended 1990), and it is unlikely that most foreign air carriers entering U.S. airspace are adhering to or are aware of the § 175.702(b)(2) operational requirement. This comment is not within the scope of this rulemaking.

The only substantive changes introduced in § 175.702 in the NPRM were the inclusion of reference to a FISSILE label in § 175.702(b), a restriction to a total CSI of 50 in § 175.702(b), and the introduction of an upper limit of 200 TI for cargo aircraft only. The remaining changes were the rearrangement and renumbering of the previous requirements.

Because we did not propose to adopt the segregation scheme of the ICAO Technical Instructions in our NPRM, we are unable to introduce these changes in this final rule. Consideration of the discrepancy between § 175.702 and the ICAO regulations may be considered in a future rulemaking.

A commenter stated packages should be labeled “Danger—Radioactive Material” rather than “fissile.” Another commenter stated that the CSI should be included in the shipping description for fissile material packages and that the fissile label is inadequate and should have more information because 99.9% of the population doesn't know what that means. The commenter suggested adding the radiation symbol and the words “Very Dangerous, Radioactive. Keep far away from public and animals. Guard at all times.” A commenter stated that it is not evident that there is a benefit in substituting the CSI for the TI and that, to minimize damages, the maximum amount of information should be given. The same commenter stated that all packages should be labeled Dangerous—Radioactive Material and a radiation warning symbol should be attached to every package. Another commenter supported the proposal to use the new “Fissile” label and the Criticality Safety Index (CSI), stating that the use of the CSI value will remove a source of confusion in the old TI values and the resulting enhancement of the safety of shipments makes the extra efforts necessary to implement this proposal worthwhile.

We agree that it is important that communications be as clear as possible, that their impact correspond to the hazard, and at the same time that the shipper, carrier or first responder not be so overwhelmed by information that the probability of errors is increased rather than diminished. For this reason we feel that the uncoupling of the concepts of TI, which refers to the external radiation hazard, and CSI, which refers to the criticality hazard, is an important improvement over the historical TI, which could have resulted from either of these hazards.

Because the two hazards are quite different, the use of one of various phrases involving the words “radioactive material” on a fissile material package without a Fissile label would actually convey less information than the presence of the Fissile label on the package. In addition, it should be noted that all radioactive material packages, aside from excepted packages and certain LSA and SCO shipments (for which the markings “RADIOACTIVE-LSA” or “RADIOACTIVE-SCO” are substituted), are required to have the proper shipping name marked on the package, and with the adoption of the TS-R-1 proper shipping names, all radioactive material proper shipping names start with the words “Radioactive material.”

A commenter questioned why Type C packages and fissile LSA and SCO are exempt from proper shipping names and UN ID numbers. We have not adopted proper shipping names and UN identification numbers for Type C packages, or for fissile LSA material and SCO, because we have decided not to recognize these categories in HMR.

A commenter stated that plutonium weight should not replace the activity but may be added to it in the shipping documents and package labels. We note that this is in fact what appears in the proposed language for §§ 172.203(d)(3) and 172.403(g)(2), and has been the case

previously. The change in these two paragraphs was the removal of reference to plutonium-238 as a fissile nuclide.

Issue 5: Low Specific Activity (LSA) materials and Surface Contaminated Objects (SCO)

Background.

On September 28, 1995, in a final rule published under Docket HM-169A (60 FR 50292), we refined the existing Low Specific Activity (LSA) and Surface Contaminated Object (SCO) regulations by adopting complementary, but not additional, features of the LSA and SCO provisions of the IAEA regulations. This approach was considered best because it offered minimal changes to existing requirements while facilitating international transport consistent with IAEA regulations. Shortly after implementing this new regulatory program, we recognized the shortcomings of not adopting the Safety Series No. 6 definition of contamination. We are now bringing the HMR into closer harmony with TS-R-1 by adopting the IAEA definition of contamination.

In accordance with TS-R-1, we have included the phrase “and other ores containing radioactive materials intended to be processed for the use of these radionuclides” in the category of LSA-I referring to uranium and thorium ores and concentrates of such ores.

TS-R-1 (paragraph 226) contains a new category of LSA-I material, consisting of radioactive material, excluding non-excepted fissile material, in which the activity is distributed throughout and the estimated average specific activity does not exceed 30 times the activity concentration exemption values. The purpose of this category is to allow shipment as LSA-I of very low specific activity materials containing one or more of a variety of radionuclides. We are adopting this new category in the definition of LSA-I. A previous LSA-I category, which specifically included 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

−

1

A

2

/g, has been eliminated. The specific materials,

e.g.

, earth, concrete, and rubble, previously listed in the definition may still be classified as LSA-I, as long as they meet the requirements of the new definition.

We are also providing an authorization to transport unpackaged LSA-I and SCO-I by means of qualified tank containers, freight containers and metal intermediate bulk containers as industrial packagings, types 2 and 3 (IP-2 and IP-3). The authorization to use qualified tank containers, freight containers and metal intermediate bulk containers as industrial packagings and the other packaging changes made for LSA and SCO will greatly simplify the HMR with no increase in risk.

We have eliminated the previous paragraph § 173.427(d), which excepted LSA material and SCO that conform to the provisions of 10 CFR 20.2005 from all requirements of the HMR for Class 7 (radioactive) materials, when offered for transportation for disposal or recovery by means other than aircraft. Such material is 1.85 kBq (0.05 μCi) or less of H-3 or C-14 per gram of liquid scintillation counting medium or of animal tissue. These exceptions are no longer needed since the TS-R-1 exemption activity concentrations for these materials adopted in this final rule are 1 × 106 Bq/g (27 μCi/g) for H-3 and 1 × 10

4

Bq/g (0.27 μCi/g) for C-14;

i.e.,

they are greater than the concentrations previously excepted. Note, however, that this does not mean that these materials would be exempt from the provisions of the HMR relating to other hazard classes.

Incorporating these changes into the HMR greatly simplifies the LSA and SCO regulations by bringing them into closer harmony with the TS-R-1. Specifically, the addition of a contamination definition and the authority to transport unpackaged LSA and SCO better focuses the regulations on radioactive material that truly poses a hazard to persons, property, and the environment.

Discussion.

Several commenters were concerned that the definitions and use of the terms LSA and SCO by DOT and NRC are not totally consistent and encouraged the review of the use of these terms to ensure compatibility with TS-R-1. We agree. This inconsistency has been resolved in this and the NRC's final rules.

Two commenters disagreed with the decision to remove the LSA-I definition of mill tailings, contaminated earth, concrete, rubble or other debris with average specific activity less than 10

−

6

/g, since much of the LSA shipped today is from this category. The commenter stated that eliminating these categories from the regulation will cause confusion and shipping delays. The specific materials mentioned,

e.g.,

earth, concrete, and rubble in the previous definition may still be classified as LSA-I as long as they meet the requirements of the new definition. Furthermore, it is believed the revised activity limits will ultimately reduce confusion and shipping delays by standardizing with the international community and the content of TS-R-1. Training on the new requirements should eliminate any confusion or shipping delays due to the revised definition.

One commenter stated that the actual meaning of “unpackaged” as discussed on 67 FR 21336-21337 and 21358 was unclear. The commenter noted that we had proposed to allow transport of unpackaged LSA-I and SCO-I in § 173.427. The commenter correctly interpreted the proposal to mean that LSA-I and SCO-I material may be shipped unpackaged in accordance with the proposed modification of § 173.427(c) which requires for the unpackaged material, other than for ores containing only naturally occurring radionuclides, that there be no escape of the contents from the conveyance nor a loss of shielding (Shipment of unpackaged LSA-I or SCO-I must also be by exclusive use; note however that unpackaged SCO-I is allowed to be transported non-exclusive use if the conditions of the modified § 173.427(c)(2) are met.) The commenter also correctly concluded that an LSA-I or SCO-I shipment no longer is required to be in a DOT Specification 7A, an industrial packaging, or a strong tight packaging, as is currently required by regulation, if the requirements of the modified § 173.427(c) are met.

One commenter incorrectly assumed that SCO-I material, such as pipes, can serve as their own packaging. The commenter cited TS-R-1 paragraphs 241 (a)(iii) and 523(c) and supplemental TS-G-1.1 (ST-2) information. Specifically, it was stated that SCO-I is allowed to have non-fixed contamination on inaccessible surfaces in excess of the values specified for accessible surfaces. Therefore, items such as pipes resulting from the decommissioning of a facility can be prepared for unpackaged transport in a way to ensure that there is no release of non-fixed contamination from inaccessible surfaces (for which allowable contamination levels may exceed the accessible surface non-fixed contamination limits) into the conveyance by, for example, applying end caps or plugs at both ends of the pipes. The commenter went on to state that the same principle applies equally to valves, compressors, tanks, or other surface contaminated articles which, because the contamination that renders the article SCO is limited to internal surfaces, may effectively serve as their own packagings. While the effective end result is virtually the same, the commenter is mistaken in saying these items serve as their own packaging. Rather, if they meet the definition of

SCO-I material, or suspected non-fixed contamination levels exceed the accessible surface non-fixed contamination limit, but measures are taken to ensure radioactive material is not released into the conveyance by making these surfaces inaccessible, thereby rendering the material fully compatible with the definition for SCO-I, then the material may be transported unpackaged in accordance with § 173.427(c).

The commenter also indicated that the LSA-I and SCO-I provisions addressed in paragraph 540 of TS-R-1 state that, when these materials are transported according to the provisions of paragraph 523, the marking “RADIOACTIVE LSA-I” or “RADIOACTIVE SCO-I” described in paragraph 540 is optional, and is not mandated by (the IAEA) regulation. The commenter encouraged DOT to permit similar flexibility in marking SCO and LSA materials. We interpret this to mean that the commenter would like to have the freedom to make exclusive use shipments of LSA-I or SCO-I without such markings.

We believe that, in accordance with past requirements for similar marking of domestic shipments of LSA or SCO that are required to be transported exclusive use, such markings serve the useful purpose of alerting emergency response personnel, Class 7 (radioactive) material is present in relatively low concentrations. We have therefore decided to retain this requirement. However, the comment focuses our attention on the lack of detail in § 173.427 in our proposed rulemaking concerning transport requirements for unpackaged LSA-I materials and unpackaged SCO-I. Therefore, in this final rule we have included wording in § 173.427(a)(4), (a)(6)(iii), and (a)(6)(vi) to indicate that unpackaged LSA-I and SCO-I are subject to the same transport controls as packaged LSA material and SCO.

Two commenters stated that the new definition for contamination and LSA-I will allow radioactive material to enter industrial and consumer goods. Another commenter stated that the LSA-I definition allowing exemption of materials having an estimated specific activity up to 30 times the exempt activity concentration should be eliminated because it fits the definition of volumetrically contaminated material and neither the NRC nor DOE currently allows for release or recycle of volumetrically contaminated radioactive materials.

We believe the commenters misinterpreted the proposed § 173.403 definition of LSA-I. No section of the proposed LSA-I definition provides an exemption, rather the sections provide bounding criteria of what may be considered LSA-I material.

A commenter stated that all ores, even if not intended to be processed, should be regulated because in the past certain companies have contaminated large areas from ores. As stated previously in Issue 2, we will continue to regulate natural materials and ores that are not intended to be processes for their radioactive content, when their specific activities are greater than ten times the activity concentration exemption values in § 173.436. One commenter stated that external dose rates for LSA and SCO should be required to be less than 1 mrem/year at 3 meters. We believe this comment is outside the scope of the rulemaking.

This commenter also stated there should be no exemptions for H-3 or C-14 in animal tissues. These exceptions have been removed in the final rule since the TS-R-1 exemption activity concentrations for these materials adopted in this final rule are 1 × 10

6

Bq/g (27 μCi/g) for H-3 and 1 × 10

4

Bq/g (0.27 μCi/g) for C-14 (

i.e.,

they are greater than the concentrations previously excepted). Note, however, that this does not mean that these materials would be exempt from the provisions of the HMR relating to other hazard classes.

Several commenters disagreed with the new rules that would allow LSA-I and SCO-I to be transported unpackaged, citing the conveyance could become contaminated. We agree that given the amounts of radioactive material contained in LSA-I and SCO-I materials there is a likelihood that cross-contamination of the interior of a conveyance used for unpackaged transport of these materials, in accordance with the proposed § 173.427(c), could occur. However, in order to prevent the spread of contamination to subsequent non-radioactive material shipments in the same conveyance, it is incumbent upon the carrier of an exclusive use shipment to ensure that the conveyance is surveyed and decontaminated, if necessary, in accordance with § 173.443(c), prior to unrestricted release of the conveyance. The carrier may perform such measurements, or these may be made by the consignee or other persons, through appropriate arrangements among the interested parties.

One commenter stated that it is not clear in the definition for “contamination” what is meant by the statement “Non-fixed (removable) radioactive contamination is not significant if it does not exceed the limits specified in § 173.443.” We point out that our definition of contamination is similar to our definition of radioactive material, in that the definition designates a threshold value below which the material in question is not subject to the Class 7 hazardous materials transport regulations. In that context we agree that the statement referred to by the commenter is ambiguous and, if “Non-fixed (removable) radioactive contamination” were interpreted as referring to the physical (non-regulatory) definition of contamination, is redundant. Hence, we have removed this phrase from the definition of contamination.

The commenter also requested that the meaning of the terms “distributed throughout” and “estimated average specific activity” be clarified in the definition for LSA-I, and asked whether these terms are intended to be applied as discussed in NUREG-1608/RSPA Advisory Guidance 97-005 for LSA materials. The guidance concerning “distributed throughout” and “essentially uniformly distributed” would be appropriate as provided in NUREG-1608, “Categorizing and Transporting Low Specific Activity Materials and Surface Contaminated Objects.” For packages containing at least 0.2 m

3

of LSA material, ten or more equal volumes no greater than 0.1 m

3

each, of objects or materials that are “distributed throughout,” should not vary by more than a factor of ten. The specific activity among similarly defined volumes for materials that are “essentially uniformly distributed” should not vary by more than a factor of three. It should be noted that, where the LSA materials contain radionuclides in quantities less than 1 A

2

, this determination may be made either quantitatively or qualitatively. The “estimated average specific activity” for radioactive material “distributed throughout” would be an arithmetic average specific activity of material where the range of specific activities does not vary by more than a factor of ten.

Issue 6: Uranium Hexafluoride (UF

6

)

Background.

Uranium hexafluoride (UF

6

) packaging and transportation is regulated under both NRC and DOT requirements. The HMR contain provisions that govern many aspects of UF

6

packaging and shipment preparation. The NRC regulates fissile materials and Type B packaging designs for all materials. Since UF

6

may be a fissile material, it may also be regulated by the NRC.

TS-R-1 contains detailed requirements for UF

6

packagings designed for more than 0.1 kg UF

6

. First, TS-R-1 requires the use of the International Organization for Standardization (ISO) Standard 7195, “Packaging of Uranium Hexafluoride (UF

6

) for Transport,” instead of the ANSI N14.1 standard, previously referenced in DOT's regulations, with the condition that approval by all countries involved in the shipment is obtained (

i.e.

, multilateral approval (Paragraph 629)). Second, TS-R-1 requires that all packages containing more than 0.1 kg UF

6

meet the “normal conditions of transport” drop test, a minimum internal pressure test and the hypothetical accident condition thermal test (Paragraph 630). However, TS-R-1 does allow a national competent authority to waive certain design requirements, including the thermal test for packages designed to contain greater than 9,000 kg UF

6

, provided that multilateral approval is obtained. Third, TS-R-1 prohibits use of packages utilizing pressure relief devices (Paragraph 631). Fourth, TS-R-1 includes a new exception for UF

6

packages, regarding the evaluation of a single package.

This new exception (Paragraph 677(b)) allows UF

6

packages to be evaluated without considering the in-leakage of water into the containment system if the packages satisfy certain specified conditions. Under these conditions, a single fissile UF

6

package does not have to be shown to be subcritical under the assumption that there is water inside the containment system. This provision only applies when there is no contact between the valve and any other component of the cylinder under hypothetical accident tests and the valve remains leak-tight following the thermal test, and when there is a high degree of quality control in the manufacture, maintenance, and repair of packagings coupled with tests to demonstrate closure of each package before each shipment. In addition, competent authority package design certificates are also required for international shipments of uranium hexafluoride (paragraph 828).

Commenters to the December 28, 1999 ANPRM asked for the following information to be included in the HMR: (1) Clarification of the requirements for new cylinders, cleaned cylinders, and cylinders containing residual amounts of UF

6

(heel cylinders); (2) additional details regarding approval provisions; and (3) transitional or grandfathering provisions. We agreed with the need for additional information and included the requested guidance in the proposed and final rule. Furthermore, we recommend that shippers and carriers of UF

6

consult with IAEA Safety Guide TS-G-1.1, “Advisory Material for the IAEA Regulations for the Safe Transport of Radioactive Material,” for further clarification.

In this final rule we have incorporated the TS-R-1 changes for packagings containing more than 0.1 kg of UF

6

. We have required that the packagings meet the pressure, drop and thermal test requirements found in paragraph 630. We have prohibited the use of pressure relief devices and provided designated packaging certification identification marks in accordance with IAEA TS-R-1 paragraph 828. We have not incorporated our proposal from the NPRM to allow uranium hexafluoride to be packaged and transported in accordance with ISO 7195. The reason is that the 1993 revision of ISO 7195 referenced in TS-R-1 is inconsistent with the ANSI N14.1 requirements, and there has been a delay in publishing a new revision which harmonizes the two standards.

Discussion.

Two commenters supported RSPA's position to make only minimal changes to the regulation of uranium hexafluoride. While the commenters did not support the inclusion of industry consensus standards in regulations, they did support RSPA's recognition of the compatibility of ISO 7195 with ANSI N14.1.

One commenter disagreed that the thermal test should be required for domestic shipments of cylinders containing natural or depleted UF

6

given how extremely unlikely it would be for these cylinders to encounter thermal conditions similar to those of the hypothetical accident conditions and the safety basis for imposing such a requirement is questionable. The commenter referenced USEC's study “Probabilistic Safety Evaluation of 48-inch Loaded Depleted and Natural UF

6

Cylinders Involved in the ST-1 Regulatory Fire.” The commenter noted the study of North American shipments of the 48-inch cylinders showed the expected frequency of occurrence of the regulatory fire resulting in cylinder rupture was extremely low, ranging from 1,800 to 29,000 years, depending on the mode of shipment.

Another commenter stated that large quantities of depleted UF

6

(about 60,000 Type 48G packages filled with UF

6

tails) are presently in storage. Furthermore, the DOE issued the “Final Programmatic Environmental Impact Statement for Alternative Strategies for the Long-Term Management and Use of Depleted Uranium Hexafluoride” on April 23, 1999. The document considered the environmental impacts, benefits, costs, and institutional and programmatic needs associated with the management and use of approximately 700,000 metric tons of depleted uranium hexafluoride. In the Record of Decision for the Long-Term Management and Use of Depleted Uranium Hexafluoride, a decision has been made to convert the depleted UF

6

inventory to depleted uranium oxide for use, storage and disposal, as necessary. Approximately 4,700 cylinders of depleted UF

6

at one facility will need to be transported to a conversion facility. The commenter noted that if the proposed requirements for thermal protection are incorporated into the HMR for the depleted uranium hexafluoride cylinders, costs for overpacking and transporting these cylinders will increase substantially without any demonstrated additional safety benefit. The commenter recommended that the current HMR requirements for cylinders of depleted UF

6

be retained for domestic transportation for a period of five years.

Although the predicted frequency of occurrence of a fire resulting in a cylinder rupture is arguably low, when considering the potential increase in societal risks resulting from transport accidents involving fire and the long-term benefits ensuing from international radioactive material transport harmonization resulting from requiring thermal tests for packages designed to contain UF

6

, we believe requirements for the thermal tests for domestic shipments are necessary.

One commenter stated the proposed revisions to modify the packaging requirements for uranium hexafluoride would relax the current requirement that a fissile material package must be designed, or the contents limited, so that a single package would be critically safe if water were to leak into the containment vessel. The commenter suggests the proposed regulations would provide an exception whereby a single fissile UF

6

package does not have to be shown to be subcritical under the assumption that there is water inside the containment system as long as certain conditions are met. The commenter concluded that given the potential serious consequences of a criticality accident, this proposed revision should not be considered or adopted in the absence of better justification and analysis. We disagree. Although this new section of the IAEA regulations (Paragraph 677(b)) allows UF

6

packages to be evaluated without considering the in-leakage of water into the containment system if the packages satisfy certain specified conditions

described above in the Discussion section, this is not a relaxation of previous regulatory requirements, rather, it is an enumeration of existing regulatory agency practices.

Issue 7: Air Transport Requirements

Background.

TS-R-1 has introduced two new concepts for the air transport of radioactive material: the Type C package (paragraphs 230, 667-670, 730, 734-737) and Low Dispersible Material (LDM). Type C packages are designed to withstand severe accident conditions associated with air transport without loss of containment or significant increase in external radiation levels. The LDM is a material exception to these new air transport standards that is granted based on a material's limited radiation hazard and low dispersibility.

If qualified as LDM, material in quantities that would otherwise require a Type C package could continue to be transported by aircraft in a Type B package. U.S. regulations do not contain a Type C package or LDM category, but do have specific requirements for the air transport of plutonium (10 CFR 71.64 and 71.74). These specific NRC requirements for air transport of plutonium will continue to apply.

The Type C requirements apply to all radionuclides packaged for air transport that contain a total activity value above 3,000 A

1

or 100,000 A

2

, whichever is less, for special form material, or above 3,000 A

2

for all other radioactive material. Below these thresholds, Type B packages may be used in air transport. The Type C package performance requirements are significantly more stringent than those for Type B packages. For example, a 90-meter per second (m/s) impact test is required instead of the 9-meter drop test. A 60-minute fire test is required instead of the 30-minute for Type B packages. These stringent tests are expected to result in package designs that will survive more severe aircraft accidents than Type B package designs.

The LDM specification was added in TS-R-1 to account for radioactive materials (package contents) that have inherently limited dispersibility, solubility, and radiation levels. The test requirements for LDM to demonstrate limited dispersibility, and leachability are a subset of the Type C package requirements (90-m/s impact and 60-minute thermal test) with an added solubility test, and must be performed on the material without packaging. The LDM must also have an external radiation level below 10 mSv/h (1 rem/hr) at 3 meters. Specific acceptance criteria are established for evaluating the performance of the material during and after the tests (less than 100 A

2

in gaseous or particulate form of less than 100 micrometer aerodynamic equivalent diameter and less than 100 A

2

in solution). These stringent performance and acceptance requirements are intended to ensure that these materials can continue to be transported safely in Type B packages aboard aircraft. LDM must be certified as such by the Competent Authority (Paragraphs 803, 804, 828, 830).

In 1996, the NRC communicated to the IAEA that the NRC did not oppose the IAEA adoption of the newly created Type C packaging standards (letter dated May 31, 1996, from James M. Taylor, EDO, NRC, to A. Bishop, President, Atomic Energy Control Board, Ottawa, Canada). However, Mr. Taylor stated in the letter that, to be consistent with United States law, any plutonium air transport to, within or over the United States will be subject to the more rigorous U.S. packaging standards.

A commenter to our 1999 ANPRM asserted that the testing criteria for Type C packages are inadequate. For example, the commenter questioned the rigorousness of the testing described in TS-R-1, indicating that the minimum acceptable impact speed should be increased to at least 129 m/s, as was mandated by Congress. Several commenters stated that it is unclear what the differences are between a Type B and Type C package and that the definitions should be clarified. Several commenters supported the addition of the term LDM and recommended its incorporation into the HMR. Finally, one commenter suggested that the new concept of LDM was introduced to offset the problems encountered in developing a Type C package. The commenter further asserted that the nuclear industry would attempt to certify reprocessed fuel known as MOX as LDM. The commenter believed there are significant safety implications regarding the movement of these substances via transportation by air and very strongly opposed any adoption of requirements in this area.

According to the DOT and NRC MOU, the NRC has responsibility for matters concerning packagings for fissile and greater-than-Type-A quantities of radioactive material. The NRC is not adopting the concepts of Type C packages or LDM at this time. In accordance with the NRC position, RSPA is not adopting the IAEA standards for Type C packaging or LDM in this final rule.

Discussion.

All commenters supported the proposal not to adopt the IAEA standards for Type C packaging or Low Dispersible Material. Therefore, as proposed in the NPRM, we are not adopting the IAEA standard for Type C packaging or LDM.

Issue 8: Fissile Material Package and Transport Requirements

Background.

Under the MOU between DOT and NRC, the NRC establishes the packaging requirements for the transport of fissile radioactive material, including excepted fissile material (

i.e.

, fissile material which may be transported as if it were non-fissile Class 7 (radioactive) material). In February 1997, the NRC published an emergency final rule (62 FR 5913, February 10, 1997) to amend 10 CFR 71 with respect to the regulations for shipping small quantities of fissile material. This rule was issued in response to a regulatory defect in the fissile material exemption regulations in § 71.53 of 10 CFR identified by an NRC licensee.

Based on the public comments on the emergency final rule, the NRC contracted with Oak Ridge National Laboratory (ORNL) to perform a thorough analysis of the possible hazards involved and to provide recommendations. In July 1998, the NRC published ORNL's conclusions as NUREG/CR-5342, entitled “Assessment and Recommendations for Fissile-Material Packaging Exemptions and General Licenses Within 10 CFR Part 71.” Based on the research and recommendations of this report, the NRC in its NPRM to harmonize 10 CFR 71 with TS-R-1, proposed several changes to its requirements for fissile exemptions, which were reiterated in § 173.453 of our NPRM. As a result of comments received by the NRC to the proposed wording in its NPRM, it has made several modifications in its final rule, and we have adopted those changes in this final rule. For further information the reader is directed to the NRC's discussion of Issue 16 in its final rule.

In its NPRM, the NRC also proposed the introduction of a Type B(DP) package, to be certified for use and used both to transport and to store spent nuclear fuel. Such a package would be issued an NRC Certificate of Compliance approving the design of a spent fuel (fissile material) transportation package, in accordance with the requirements of subpart I of 10 CFR 71, and an NRC Certificate of Compliance approving the design of a spent fuel storage cask, in accordance with the requirements of subpart L of 10 CFR 72. To maintain consistency between the NRC and DOT's regulations, we proposed wording in subpart I of 49 CFR 173, in our NPRM in which the concept of a

Type B(DP) was introduced. As a result of comments received by the NRC to the proposed wording in its NPRM, it has decided to withdraw reference to a Type B(DP) package in its final rule. Consequently, we have revised the text in this final rule to remove references to a Type B(DP) package.

As a result of the publication of our ANPRM, several commenters asserted that the TS-R-1 requirements for conducting criticality analyses for fissile materials being shipped by air required clarification. The commenters stated that a guidance note should be issued and included in TS-R-2 (now referred to as TS-G-1.1) when published and the HMR should reflect this clarification. Although we have no authority to make unilateral changes in IAEA documents, we stated we would analyze problems in performing criticality analyses for the shipment of fissile materials by air as they arise, in coordination with the NRC, and the possibility of issuing a guidance document would be considered if it appeared to be an appropriate means to address any problems encountered.

Other commenters stated DOT should provide clear guidance regarding the requirements for obtaining U.S. Competent Authority Certificates for air transport of fissile materials prior to formal harmonization of TS-R-1 and the HMR. However, the NRC and DOT did not propose to adopt TS-R-1 provisions for Type C packages or Low Dispersible Radioactive Material (LDRM). The practical consequence of this is that RSPA's Office of Hazardous Materials Safety, as U.S. Competent Authority, does not intend to issue Certificates of Competent Authority for Type C packages or LDRM. Other Certificates of Competent Authority for the international transport of fissile materials by air will be issued in accordance with §§ 173.471 and 173.473.

Accordingly, in this rulemaking we are: (1) Adopting the NRC fissile material exemption provisions in § 173.453; (2) removing the definition for “fissile material, controlled shipment,”; (3) revising §§ 173.457 and 173.459 to remove the references to “fissile material, controlled shipment”; and (4) establishing requirements for non-exclusive use and exclusive use shipments of fissile material packages based on TS-R-1 package and conveyance CSI limits, since we feel that this will considerably simplify the transport of fissile material packages, while maintaining appropriate criticality safeguards.

Discussion.

We received four comments concerning fissile material package and transport requirements regarding the fissile material exceptions in the proposed § 173.453. In accordance with the MOU, we ensured that the comments had been addressed by the NRC review and we have incorportated the revised NRC language for fissile material exceptions into § 173.543 in this final rule. It should be noted that the final rule concerning fissile material exceptions applies to domestic situations only. International transport concerning fissile material exceptions will also need to comply with the requirements of the International Civil Aviation Organization's Technical Instructions (ICAO), the International Maritime Dangerous Goods Code (IMDG Code) or Canadian regulations, as applicable.

A commenter stated that the wording of proposed § 173.417(c) is confusing as it is presently written since the 1A2 steel drum/Type A combination packaging is not a Type B packaging and then suggested that “Type B packaging” be changed to “packaging for fissile material.” We agree and the change has been incorporated into this final rule.

Issue 9: Transitional Requirements

Background.

Transitional requirements typically authorize: (1) Continued use of existing package designs and packagings already fabricated, although some additional requirements may be imposed; (2) completion of packagings that are in the process of being fabricated or that may be fabricated within a given time period after the regulatory change; and (3) limited modifications to package designs and packagings without the need to demonstrate full compliance with the revised regulations, provided that the modifications do not significantly affect the safety of the package.

Each transition from one edition of the IAEA regulations to another (and the corresponding revisions of the NRC and DOT regulations) included transitional provisions. The transitional provisions in TS-R-1, the latest version, are found in paragraphs 815-818 of that document. Although provisions for continued use of packages and special form sources previously approved in accordance with the 1973 and 1985 editions of the IAEA regulations remain virtually unchanged, TS-R-1 does not provide transitional provisions for packages approved under the 1967 edition of the IAEA regulations.

The TS-R-1 transitional provisions will have several impacts. The primary impact is that under TS-R-1 provisions, Safety Series No. 6 (1967) approved packagings will no longer be authorized. The second impact is that fabrication of packagings designed and approved under Safety Series No. 6 1985 (As Amended 1990) must be completed by a specified date.

In TS-R-1, packages approved for use based on Safety Series No. 6 (1973/1973A revisions) will continue to be authorized for use and can continue to be used through their design life, provided they meet the following conditions: (1) Multilateral approval is obtained, as applicable; (2) TS-R-1 quality assurance requirements are adhered to; (3) TS-R-1 A

1

and A

2

activity values are used; and, (4) if applicable, approval for air transport of fissile radioactive material is obtained. While existing packagings are still authorized, no new packagings may be fabricated to this design standard. Should a safety issue associated with the package be identified, this packaging will need to meet all of the applicable requirements of TS-R-1. In summary, a packaging designed to Safety Series No. 6 (1973/1973A) may continue to be used.

In similar fashion, TS-R-1 states that those packages approved for use based on Safety Series No. 6 (1985/1985A revisions) may continue to be used, provided the packaging meets the following conditions: (1) TS-R-1 quality assurance requirements, (2) TS-R-1 A

1

and A

2

activity values, and, (3) if applicable, approval for air transport of fissile radioactive material. After December 31, 2003, use of these packages may continue under multilateral approval if applicable. Should a safety issue associated with the package be identified, the packaging will need to meet all of the applicable requirements of TS-R-1. Additionally, use of this packaging will end on December 31, 2006. Beginning January 1, 2007, all packages shipped internationally will be required to meet TS-R-1 packaging approval requirements.

The NRC has stated in its final rule that it believes that packages approved under the 1967 edition of Safety Series No. 6 lack the enhanced safety features that have been incorporated in the packages approved under later revisions of the regulations. NRC cites the fact that more recent packages are required to be more leakage resistant, and that all packages presently approved by the NRC must satisfy the pertinent quality assurance requirements described in subpart H of 10 CFR 71. A more complete list of enhancements to package safety requirements since the 1967 IAEA regulations is found in the NRC NPRM (67 FR 21406), and includes: (1) The introduction of the

A1/A2 system; (2) standards for defining acceptable containment system performance; (3) the immersion test for Type A fissile material packages; (4) maximum normal operating pressure; (5) the definition of appropriate test parameters for evaluation of the package under normal and accident condition tests; and (6) quality assurance requirements for the design, fabrication, and use of Type B packages. NRC has also noted that the elimination of packages approved against the 1967 IAEA regulations first became public knowledge in 1996, with the IAEA's publication of ST-1 (later renamed TS-R-1). The NRC is therefore phasing out all of its package design certificates based on the 1967 IAEA Regulations.

In its analysis, NRC considered that designs for 1967-based packages would fall into one of five categories: (1) Package designs that may meet current safety standards with no modifications but have until now not been submitted to the NRC for review against these standards; (2) package designs that can be shown to meet current safety standards after relatively minor design changes; (3) spent fuel casks certified to the 1967 standards, for which stringent quality assurance requirements for design and fabrication did apply; (4) package designs that cannot be shown to meet current safety standards; and (5) packages for which the safety performance of the package design under the current safety standards is not known. NRC believes that it is appropriate to phase out use of designs that fall into the last two categories.

DOT Specification 6L, 6M, 20WC and 21WC packages are packages that have not been shown to satisfy packaging requirements of the 1973, 1985, or 1996 IAEA radioactive material transport regulations. In accordance with the decision by the NRC to phase out packages approved against the 1967 IAEA Regulations, and recognizing that under the MOU between the two agencies that NRC has cognizance over domestic use of Type B and fissile material packages, we proposed in our NPRM that as of the effective date of this final rule no new manufacture of packages of these types be allowed, and that all use of these packages cease as of two years following the effective date of this final rule.

In this final rule, to provide more time for affected parties to adjust to the new requirements and in consultation with the NRC, we have doubled the transition period to four years from the effective date of the rule, and have set the effective date to be nine months after publication of this final rule in the

Federal Register

. Thus, from the date of publication of this final rule, affected parties will have approximately five years to establish appropriate packaging alternatives.

It has been known since the publication of IAEA's ST-1 in 1996 that packages designed in accordance with the 1967 IAEA regulations would no longer be allowed for international transport. Moreover, NRC made clear that it was considering adopting this restriction for domestic transport. Thus, by the end of the five year period affected parties will have had approximately 12 years to adapt to the domestic elimination of these packages.

Discussion.

Commenters to the NPRM generally stated that some type of transitional arrangements should be provided in the HMR to clarify how packages manufactured under earlier versions of Safety Series 6 will be phased out, and how and if these packages may be re-validated. One commenter suggested that we should provide a transition period prior to the full adoption of TS-R-1 that would provide shippers and carriers the flexibility to make shipments of radioactive materials under the current HMR requirements (equivalent to Safety Series 6) or under TS-R-1. Several commenters stated that for domestic shipments, we should provide a one-year transition period for complete implementation of the TS-R-1 regulations. Other commenters suggested that we incorporate the following statement into the HMR: “Packages that have been prepared for transport prior to (five-year effective date) may be offered for transport provided that the labeling, marking, and placarding provisions of the regulations in effect at time of shipment are complied with.”

We agree that shippers and carriers will need time to adjust to the changes in the regulations introduced in this final rule, and that there should be a sufficiently long transition period for affected shippers to adapt to the removal of the DOT Specification packages. Accordingly, as we mentioned earlier, for most of the new requirements we are delaying the effective date of this rule to one year after its publication in the

Federal Register

. In addition, for reasons discussed below and in Section D, “Regulatory Flexibility Act, Executive Order 13272, and DOT Regulatory Policies and Procedures,” we are substantially lengthening the transition period before use of the DOT Specification packages is prohibited, from the two years originally proposed to four years after the effective date of this final rule. Thus, the regulated community will essentially have five years from the date of publication of this final rule before all use of the DOT Specification packages must cease, unless they have been shown to satisfy current performance requirements and are certified by the NRC.

A commenter supported the overall intent of the proposed modifications. As the number of international shipments increases, a common set of regulations will enhance the safety of these shipments. However, the commenter stated that DOT and NRC regulations should also provide allowance for domestic shipments that are unique to the United States. One example is the grandfathering of shipping packages. The commenter suggests that packages manufactured to the 1967 safety standard should be allowed to continue in domestic service, unless a safety problem is identified. The commenter stated that it is a small business and has estimated that replacing the two-year old DOT Specification 6L packages currently in use with newly-designed packages will cost about $500,000.

Two commenters reiterated how important the grandfathering issue pertaining to previously approved packages is to the future success of their organization as well as other small businesses that routinely transport Type B quantities of radioactive materials domestically. The commenters questioned why some packages with proven safety records would be phased out for domestic shipments in as little as two years after the final rule is issued. They noted that significant resources have been invested in transportation packages designed specifically for certain applications, and these packages will no longer be authorized for use should the regulations change as proposed. The commenters did not support the IAEA grandfathering provision for packages designed in accordance with the 1967 standard when such package(s) are limited to domestic-only shipments.

A primary concern of the commenter was with regard to transporting iridium-192, which is used for industrial radiography, and which is an integral part of the oil and gas pipeline industry, commercial and military aircraft safety maintenance programs, and ship construction and repair. The commenter stated that his company is the only domestic commercial source of this radioisotope for industry. The commenter cited extensive shipping experience using the GE-8500 transport container, without incident, for the past 23 years and stated that if the proposed regulations are adopted, none of these containers will be available for use and

there are no other containers available in the world that meet the proposed new requirements for domestic use within the United States.

The commenter estimated that the cost of replacing these transport containers with ones meeting the proposed regulations, and having these packages reviewed and accepted by the NRC, would be at over a million dollars; and disregarding cost, it is unlikely the NRC would approve any new containers before the implementation date. Therefore, adoption of the new regulations would eliminate the company's ability to provide a domestic supply of critical radioisotope for both commercial and military applications and would dictate that only foreign companies could import this material.

A second concern expressed by the commenter was that the proposed rules would essentially remove from service any and all containers that could be used to transport isotopes from the Department of Energy's Advanced Test Reactor for medical or industrial use, and that in order to use this rare domestic reactor source for isotope production a new transportation package would have to be constructed that would meet the Safety Series 6, 1985 criteria. The commenter further stated that the time and cost associated with the design, manufacture, testing, and approval of such a container would likely exceed the financial ability of the commenter's company.

The commenter recommended currently approved DOT specification packages (such as welded special form sources inside a Type A package, within a 20WC overpack) should continue to be approved for domestic shipments. The commenter stated that the cost associated with phasing out transportation packages that have been in use safely for decades cannot be justified solely on the basis of harmonizing the regulations with the IAEA Transportation Safety Standards (TS-R-1). The commenter further recommended that DOT accept Competent Authority Certificates for foreign made Type B packages without requiring revalidation by a U.S. Competent Authority. The commenter stated that the basis for this suggestion is that revalidation by the U.S. of foreign made (Type B(U)) packages for which another country has already issued a Competent Authority Certificate in accordance with TS-R-1 is a redundancy that provides no additional benefit.

We disagree. For safety reasons it has long been NRC and DOT policy that revalidations of foreign package design approvals should be made for import and export, or for domestic use of such packages, only after we have assured ourselves that the packages do in fact meet our safety standards.

Another commenter focused on the proposal to eliminate the manufacture and use of all packages manufactured to IAEA 1967 Safety Series No. 6 requirements used for shipment of Type B quantities of special form radioactive material, two years after the effective date of the regulation. Specifically, the commenter referenced DOT Type 7A packages fitted with a metal jacket and contained in a DOT Specification 20WC overpack, and overpacks manufactured pursuant to NRC Certificate of Compliance (CoC) 6280. The commenter stated that after these packages are prohibited the only means of certifying new transportation packages (either new designs or recertifications of 1967 designs) would be via new Certificates of Compliance issued by the NRC, and there are reasons why the proposal should not be incorporated into regulation. The supporting rationale for the commenter's position can be described under five broad headings; these are discussed in detail below: (1) Increased costs; (2) safeguard/security issues; (3) safety record of 1967 Specification packages; (4) unnecessary harmonization; (5) transition period.

(1)

Increased costs:

The commenter stated that if the proposal is applied to domestic shipments, it is likely to have far different effects than those intended including unacceptably high costs for many small but important business entities, thus either substantially weakening firms or literally driving them out of business with no ready successors. The commenter suggested that there is also a potential for substantial delay in approving new designs or recertifying existing designs. The commenter's organization typically makes approximately 200 shipments per year for its operations and does not own any other overpacks suitable for its shipments. The commenter stated that there are between 100 and 200 20WC Specification containers in use in the United States today, in addition to the 15 owned and used by the commenter, and there are probably between 25 and 50 active NRC-approved 1967 containers in service, in addition to the two owned by the commenter's organization. If these estimates are accurate, the commenter asserts that the overall effect of implementation of the proposal to eliminate use of packages designed to the 1967 IAEA standards would be on the order of 10 to 15 times that projected by the commenter's organization alone.

The commenter stated that it manufactures some 1000 devices and ships them in either NRC CoC or DOT Specification containers built to the 1967 standards in current use throughout the United States, and it is certain that under the proposed regulations at least two CoCs would have to be obtained, either to requalify existing containers or to construct new ones meeting the TS-R-1 requirements. The commenter asserts that it is also possible that as many as a dozen or more CoCs would have to be obtained, depending on the NRC's licensing flexibility.

The commenter estimated that for each required CoC, it will cost at least $500,000 and take upwards of two years to design, test and obtain regulatory approval from the NRC for the corresponding new or requalified package. Thus, the commenter provided the following cost estimates: (1) Redesign/reapproval would range between $1 million and $6 million for the commenter's organization; (2) new overpack construction would cost about $50,000 each, with anticipated total costs of between $600,000 and $750,000; (3) the value of existing overpacks, with a per-unit depreciated value of about $30,000 apiece, would be lost, for a total of approximately $500,000. Therefore, the commenter estimated its overall cost of compliance to be $2-8 million. The commenter concluded that given this cost estimate compared to the commenter's organization's annual revenues and net worth, to proceed would be a sufficiently questionable economic decision that the company would, instead, probably close its doors and go out of business.

Upon consulting with the NRC, we believe that the estimated costs for certifying existing packagings or new designs against current requirements will be far less than the commenter estimated, on the order of $40,000 to $390,000 for each package design, or an estimated $120,000 to $1.17 million total (if complete redesigns consolidate content requirements to three designs). Individual packaging rework or full construction costs are further estimated at $200 to $50,000 each.

The commenter also stated that if the devices they service cannot be legally shipped, the value of these devices will be largely or totally lost from the time they need to be re-sourced or refurbished. At an average cost of approximately $50,000 per unit, this would mean an aggregate cost on the order of $50 million, distributed among several hundred customers. Since we believe a cost-effective solution will be

readily achievable, the value of the devices will not be lost, so we feel that this cost estimate is moot.

The commenter also stated that the organization's devices, which were built to be shipped in DOT Specification packages, contained source shielding and housing containers that were built under Quality Assurance standards that were not governed by the NRC's QA program in 10 CFR Part 71, §§ 71.101-71.135. As a result, the documentation or “QA Paper” for these devices may not conform to NRC QA requirements even though actual design, procurement and construction standards may have been identical or equivalent to NRC standards. Therefore, the commenter stated, it would not be possible to document the “pedigree” of such components as the shielding and the housing of these devices, which are integral to the device but technically part of the “packaging” as defined in NRC and DOT regulations (10 CFR 71.4 and § 173.403). Therefore, unless the NRC either amends or relaxes its interpretation of its QA requirements, the commenter suggests it likely that NRC will not accept packages initially designed and manufactured to DOT specifications. In that event, according to the commenter, the cost of compliance would rise dramatically, as one of three scenarios would follow:

a. Transportation containers weighing upwards of 60,000 pounds would have to be designed that could transport existing devices without taking any credit for the radioactive shielding or structural housing surrounding the source, which would require special highway authorizations and increase costs. The commenter estimated that designing, licensing and constructing such a container, with dedicated tractor and specially designed trailer, would cost upwards of $2,250,000. The cost of succeeding containers, each with its own trailer, would approach $1,000,000 apiece. Shipping costs for these containers would also be an order of magnitude higher than those for current devices ($35,000-$40,000 vs. $3000 per trip now). Even then, the transportation rig would be unable to access numerous locations that can now be reached, thus running the risk that some sources would be stranded. Therefore, this alternative, while technically feasible, is physically cumbersome and sufficiently more costly than current shipping modes that many existing customers would be tempted to buy and ship new devices rather than have existing ones re-sourced or hauled away for decommissioning.

b. Sources could be transferred at the customer's site from the existing device to a specially designed “transportation container,” using a portable hot cell transported to the customer's site. This option has not been fully cost estimated because it appears to have almost insuperable obstacles. First, most of the devices are fabricated with welded end-caps, in order to prevent tampering by unauthorized persons. As a result, removing the source is a difficult, potentially high-exposure process when conducted in the field. Second, setting up a hot cell is an unavoidably expensive business—on the order of $300,000 per installation. Even if devices were designed with screw-on end caps (and some are) and special shipping containers were designed to operate with them—thus substantially lessening the labor and radioactive exposure associated with a transfer—it would still be necessary to set up a portable hot cell. This alternative is prohibitively expensive except in extreme conditions. It is also inconsistent with the as low as reasonable achievable (ALARA) goal of minimizing occupational exposures to radiation.

c. Existing sources in existing devices manufactured to DOT specifications would become unshippable in existing packages, and their value would be lost as of the time their sources next need to be removed. There are nearly 1,000 of these devices in service throughout the U.S., so the cost to customers, at an average value of $50,000, would be $50 million. The commenter regarded this scenario as the most likely, since the cost of the other two scenarios is likely to deter market entrants.

As a result, the commenter stated that the actual total numbers of 20WC overpacks and the devices shipped in them are on the order of 10 to 15 times its own. In that event, the commenter stated that the industry-wide economic costs projected can be extrapolated as follows:

Cost of design, testing and licensing of new designs: $10,000,000 to $90,000,000

Costs of construction of new overpacks: $6,250,000 to $12,500,000

Loss of value of existing overpacks: $5,000,000 to $10,000,000

Loss of value of existing devices: $500,000,000 to $1,000,000,000.

Finally, the commenter stated that numerous participants in this market sector are small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 9 601

et seq.

, and the draft Regulatory Analysis does not account for this fact. The commenter stated that both the NRC and DOT have mis-assessed the impact of their proposals on small entities protected by the Regulatory Flexibility Act. In any event, the commenter suggests that the NRC's characterization of nuclear power plant operators as the typical type of entity affected by the proposal under discussion is incomplete. In addition, the commenter states that affected entities include hospitals, research facilities, blood banks, colleges and the like, numerous of which fall within the size or income categories of small entities.

We do not agree. We find it implausible, given activity levels that are currently routinely transported in legal weight vehicles, that these devices will require overweight vehicle transport. Therefore, we discount this cost estimate. We agree that the option of setting up satellite hot cells to perform refurbishment may not be a cost-effective viable option; however we do not rule out the possibility free market initiatives could make this a desired alternative. We do not believe there will be a loss of value to devices currently in use, since packages that conform to current safety standards will be found to replace those being phased out.

We note that the fact that a packaging may lack complete QA documentation, although “the actual design, procurement and construction standards may have been identical or equivalent to NRC standards,” is an important reason for upgrading the packaging, or for replacing it with a packaging that can be shown to satisfy current safety requirements. Only when and if it can be shown that the design, procurement and construction standards were in fact equivalent to current requirements can we have confidence that such is the case.

Assuming conservatively that on the order of 10 to 20 new package designs for the 20WC would need to be approved by the NRC, that from 50 to 100 replacements for the 20WC packagings would need to be manufactured, using typical cost estimates from the NRC of $300,000 to $390,000 for design, testing, and licensing, manufacturing costs of $50,000 per manufactured package, and the commenter's estimate of $30,000 per package for depreciation costs, we believe that a conservative estimate of the industry-wide cost can be projected as follows:

Cost of design, testing and licensing of new designs: $3,000,000 to $7,800,000

Costs of construction of new overpacks: $2,500,000 to $5,000,000

Loss of value of existing overpacks: $1,500,000 to $3,000,000

Estimated total cost to industry: $7,000,000 to 15,800,000.

Therefore, we conclude that the realistic costs are relatively modest and we believe the commenter has overestimated total industry-wide costs resulting from the proposal by almost two orders of magnitude.

With respect to the assertion by the commenter that numerous participants in this market sector are small entities, we received only three comments regarding the economic cost of removing the 1967 Specification Packages from service. In addition, NRC staff found that only 15 of 127 NRC licensed quality assurance programs belong to small entities, and that of these, only 2 or 3 would be appreciably affected by the elimination of the 1967 based packages. They concluded from these data that this requirement would not cause a significant economic impact for a substantial number of small entities.

(2)

Safeguard/security issues:

The commenter stated that at some point in time every device containing a radioactive source needs either a fresh source, refurbishment, or retirement. The commenter also stated the proposal would make devices and sources now shipped in currently approved packages not legally transportable in any currently licensed container, thus creating hundreds of sites with thousands of orphan sources that could no longer be used, could not be shipped for orderly disposition, and would have to be maintained and safeguarded indefinitely. For instance, one obsolete type of device distributed under the aegis of the former AEC is known to be located in at least five high schools and 28 colleges or universities around the country, awaiting shipment for decommissioning. According to the commenter, under the proposed regulations these would then be orphaned. Therefore, the commenter asserts that facility managements, in coordination with state governments (in Agreement States) or the NRC, must then store them safely, indefinitely, keeping them physically secure, protecting personnel against radiological hazards, and guarding against security hazards, such as theft by terrorists.

To make matters worse, the commenter suggests that as long as these devices are unable to be shipped, no entity possessing them can conduct a final radiation survey and terminate its license. Every such licensee must remain indefinitely on NRC or Agreement State rolls. In the meantime, the commenter asserts that any closure of any facility containing such a device, or any sale or other transfer or conversion, becomes virtually impossible since the current licensee must either remain on the license for the device or transfer it to another qualified potential licensee. This not only greatly complicates normal real estate transactions but basically freezes any facility in its current use and ownership indefinitely. The commenter raised the possibility that one collateral effect of the pending proposal may be that it constitutes a major federal action significantly affecting the human environment, thereby requiring a full-blown Environmental Impact Statement under the National Environmental Policy Act, 42 U.S.C. 4331

et seq.

We do not agree, especially given an effective five-year transition period from publication of the final rule, that the loss of authorization to use 1967 Specification packages could result in thousands of sources becoming orphaned. For example, a situation exists where non-licensees find themselves to be in possession of radioactive sources that they did not seek to possess, at hundreds of sites. Even with no transition time, the sources will not immediately become orphaned.

Additionally, we believe that five years will provide a sufficient transition period, in the near future, as an interim transport methodology for those devices that require refurbishment, repair, relocation etc., or if the licensee is undergoing a license termination evolution, while the concurrent process of designing, constructing, and approving packages, in accordance with current safety standards will allow sufficient time for an orderly phase out of the 1967 Specification packages.

(3)

Safety record of 1967 Specification packages:

The commenter stated that the packages designed and built to 1967 specifications and properly maintained have an excellent safety record, and that neither agency alleges any safety problem with their design, which was subjected to 30-foot drop, fire and immersion tests by Sandia Laboratory in 1968. The commenter added that both the NRC and DOT concede in their rulemaking notices that their proposal to eliminate 1967 Specification containers from domestic use does not rest on a health-and-safety foundation and that current container regulations provide adequate safety.

The commenter is correct in stating the packages were subjected to drop, fire, and immersion tests. However, concerning the 1967 Specification packages, since there is often no quality assurance program element, inadequate testing to international contemporary consensus standards, and no stand-alone safety analyses report, the packages, unless recertified to current standards, need to be recognized as being outdated and obsolete.

We also agree there is no current safety issue that would require the immediate elimination of the 1967 Specification packages. However we believe there will be an increase in the level of safety resulting from adopting the proposed regulations, and this increased level of safety is provided at a reasonable cost. Therefore, we are adopting the proposed elimination of the DOT Specification packagings, with a modified implementation time of four years from the effective date of this rule, after a one year period between publication of the final rule in the

Federal Register

and the effective date.

(4)

Unnecessary harmonization:

The commenter stated that neither the NRC nor DOT has advanced a substantial argument, other than consistency with IAEA requirements (which are not binding under U.S. law), for compelling the elimination of these containers from continued use in U.S. domestic commerce. The commenter added it is useful to incorporate technical advances in equipment into regulations, but not sensible to require costly change with respect to adequate existing equipment absent significant offsetting safety or other statutory-policy justifications. The commenter also stated that IAEA requirements, or regulations, are not self-implementing inasmuch as they do not bind the United States, or any member State, unless ratified or accepted by that State's government. Indeed, IAEA recognizes in TS-R-1 that national-level departures from its provisions may be “necessary for solely domestic purposes” and DOT is only obligated to ensure only that U.S. domestic regulations are “consistent with” international standards, and then only “to the extent practicable.” Finally, the commenter stated there is neither a tangible safety benefit to be achieved nor a definable risk to be avoided from the proposed elimination of 1967 Specification packages as applied to domestic shipment of Type B quantities of special form radioactive materials.

We agree that the IAEA regulations are not binding in the U.S., unless adopted, and have implemented exceptions when deemed necessary. Since the old packages will be replaced by packages that will have shown to conform to current safety standards, we believe elimination of the 1967 specification packages will increase the level of transportation safety.

(5)

Transition period:

The commenter urged the rulemaking be modified so as to permit the indefinite continued use of

properly maintained existing packages built to 1967 IAEA Safety Series No. 6 Specifications for the shipment of Type B quantities of special form radioactive material within the United States. However, the commenter stated any “sunset” deadline on use of any package design being phased out under this proposal should permit its continued use pending ultimate decision by the NRC on either re-certification of the existing design or approval of a new design.

The commenter suggests that if a specific “sunset” date is chosen, it should be significantly longer than the ones proposed by either the NRC or DOT, which should agree on a common “sunset” date. Due to the time necessary to design, fabricate, test and gain NRC review of a new CoC design, the commenter asserts that the two-year transition period proposed by DOT would cause a shipping hiatus even if costs were not an issue.

We agree. Due to the reasons cited earlier, and after consultation with the NRC, we are providing a nine month window from publication of this final rule in the

Federal Register

to the effective date when it becomes obligatory, and a four year transition period from the effective date before use of the DOT specification packages is no longer allowed. The total transition period from the publication of the final rule to the date when these packages may no longer be used will be approximately five years. This will increase the level of transportation safety at an acceptable cost, provide a reasonable, low-impact solution taking all concerns into consideration, and allow a sufficiently long transition period for introduction of replacement packages.

This five-year transition period is in addition to the time that it can reasonably be assumed that it became general industry knowledge that the use of these packagings would be eliminated domestically. The IAEA “Regulations for the Safe Transport of Radioactive Material” have provided a basis for U.S. radioactive material transport regulations for decades. Paragraph 713 of the 1985 Edition (As Amended 1990) of Safety Series No. 6 stated “Packagings manufactured to a design approved by the competent authority under the provisions of the 1967 Edition of these Regulations may continue to be used, subject to multilateral approval.”

The 1996 Edition of the IAEA regulations (TS-R-1) completely eliminated any transitional arrangements for the use of packagings manufactured to a design meeting the requirements of the 1967 Edition of the IAEA regulations. As a consequence of this change, DOT notified all registered users of the Certificate of Competent Authority USA/5800/B for the use of the DOT Specification 20WC packaging for import and export, including this commenter, that the 1996 IAEA regulations had removed the transitional approval provisions for Type B packages constructed in accordance with the 1967 Edition of the IAEA regulations, and that therefore, users of DOT Specification 20WC packaging would be required to show that their package meets the performance criteria of the 1996 regulations or it would have to be transported under a Special Arrangement when used for import or export.

This notification was made via written memoranda sent on each of four different occasions, in 1997, 1998, 1999, and 2000. These memoranda further stated that no Special Arrangements were envisioned after January 1, 2001, since the advent of this requirement would by that time have already been public knowledge for several years. Consequently, for those users who also used this packaging for international shipments, these notifications, along with an effective five-year transition period from the publication of this final rule, will have provided an effective transition period of more than a decade for elimination of the 20WC packaging.

Another commenter stated that DOT and NRC must recognize that while IAEA standards generally have good technical bases, they are consensus standards that do not necessarily consider the risk-informed, performance-based aspects of regulations that we have developed in the United States. Therefore, this commenter suggests that while most of the IAEA standards should be incorporated into U.S. regulations, the unique aspects of the U.S. regulations need to be considered. The commenter agrees that the IAEA standards are appropriate for international shipments, but believes that DOT and NRC regulations should also provide allowance for domestic-only applications. This would include for example, a grandfathering provision.

We believe that this rulemaking process is the appropriate forum that takes into consideration the risk-informed, performance-based aspects the commenter referenced, and that balances individual concerns with the overall lack of clarity in the ability of these packages to meet current safety standards. Therefore as discussed earlier, we have decided to allow a transition period of four years from the effective date of the rule, which is in turn set to nine months after publication of the final rule in the

Federal Register

. This will result in an effective five-year transition period from the date of the final rule publication in the

Federal Register

.

Two commenters stated that the discontinuation of DOT specification packages two years after the effective date of this rule has the potential to impact the timely remediation and closure of U.S. Department of Energy (DOE) sites and the DOE has an excellent safety record using DOT specification packages. Additionally, since significant volumes of material (9,000 packages) are presently prepared in specification packages, the commenter states that repackaging would be time consuming, very costly and would increase the risk to workers whenever it is required. Since it may take two to four years to complete the design, construction, and certification processes to replace these packages, the commenters asserted that the continued use of these packages for five years after the effective date of the rule would allow the DOE to complete many of its shipping campaigns without initiating design, certification and production of new packagings, or to do so in an orderly manner.

We agree. We believe that the two-year time frame was insufficient. We have therefore, changed the transition period to four years from the effective date of the rule, with a nine month effective date from final rule publication in the

Federal Register

. This will allow an effective five-year transition period from the date the rule is published in the

Federal Register

, which would only require a slight acceleration of remediation campaign activities.

Three commenters were concerned the separate DOT and NRC rulemaking proposals had different effective implementation dates and they encouraged DOT to work with the NRC to ensure a common effective date. We agree. We have reached consensus with the NRC to implement a four-year transition time, beginning at the effective date of the rulemakings, with a nine month effective date from final rule publication in the

Federal Register

. This change has been included throughout this final rule as appropriate.

Two commenters supported the proposal to accept the IAEA transitional requirements including the phase out of Type B specification packages and the termination of authorization of Safety Series 6 (1967) packages. The commenters stated that Specification packages and Safety Series 6 (1967) packages have not been designed and

constructed according to standards where their continued use would be consistent with the intent of the regulations. We agree, as discussed above.

Two commenters stated that an issue that is overlooked in the transition to a new regulation is the fact that recurrent training is only required once every three years. Therefore, many organizations only send their personnel to be “DOT Trained” every three years. It may therefore take three years for the shippers to recognize that there have been major changes in the regulation. The commenters recommended that serious consideration be given to reducing the time for recurrent training to one year or incorporating a three-year transition period into the proposal, consistent with these training requirements.

We do not agree. The HMR (§ 172.702(b)) states * * * “a hazmat employee who performs any function subject to the requirements of this subchapter may not perform that function unless instructed in the requirements of this subchapter that apply to that function.” Our position regarding all HMR changes is that if a new regulation is adopted, or an existing regulation is changed, that relates to the function performed by a hazmat employee, that hazmat employee must be instructed in those new or revised function specific requirements without regard to the timing of the three year training cycle (Docket HM-222B, 61 FR 27169).

A commenter stated that during the transition phase when DOT Specification packagings would still be authorized for use, the proposed rule does not appear to specify the proper shipping name that would apply for fissile material shipped in a DOT specification packaging and the final rule should make clear what name should be used during transition phase.

We agree. We consider that during the transition period, when a non-fissile or fissile-excepted Type B quantity is transported domestically in a 1967 DOT Specification package or in an NRC-approved B( ) package, the proper shipping name and UN number “Radioactive material, Type B(U) package” and “UN2916” may be used. Similarly, during the transition period when a fissile Type B quantity is transported in a 1967 DOT Specification package or in an NRC-approved B( )F package, “Radioactive material, Type B(U) package, fissile” and “UN3328” may be used.

Issue 10: Other Changes

Background.

We are requiring in § 173.424 that the active material in an instrument or article intended to be transported in an excepted package be completely enclosed by the non-active components. This is a requirement which appears in paragraph 517(c) of TS-R-1, and is a change from the wording in Safety Series No. 6. It is intended to enhance the safety of shipments of instruments or articles in excepted packages by making it explicit that the radioactive contents in such an instrument or article must be completely enclosed by the non-radioactive material of which the instrument or article is constructed in order to prevent release of the active contents under normal conditions of transport.

Discussion.

A commenter noted that the term “completely enclosed” is not defined in the NPRM. The commenter asked for clarification regarding the exception provided in § 173.424 regarding items that are “completely enclosed” by non-radioactive components. The commenter specifically asked whether items like smoke detectors, which by necessity must have openings for smoke to enter the active volume, would qualify for this exception. The commenter went on to explain that smoke alarms contain a small amount of radioactive material, Americium-241, which is embedded in a gold foil matrix within an ionization chamber, and that the thin gold-americium foil is sandwiched between a thicker silver backing and a palladium laminate. The laminate is thick enough to completely retain the radioactive material, but thin enough to allow the alpha particles to pass.

The commenter requested that RSPA clarify in the final rule that an instrument is not required to provide an air-tight enclosure for the radiation source in order to be considered “completely enclosed.” Rather, where the radioactive material is enclosed in or forms a component part of an instrument or other manufactured article where an added degree of protection is provided against escape of material in the event of an accident, such instrument or article should qualify for the exception in § 173.424.

We agree that the intent of the requirement in § 173.424 is not to exclude items such as Americium-241 smoke detectors, and the requirement that the active material be completely enclosed by non-active components is met, in the case of a smoke detector or a similar device, by the combination of the thin laminate and the positioning of the active element within the outer case, even though that case is not air-tight.

In addition to the above comment, we received numerous comments that did not lend themselves to categorization in one of the other nine issues. Therefore, we have elected to discuss these comments here.

One commenter provided a petition signed by several thousand people that called for the United States President, Vice President, Congress and all Federal, state and international regulators and legislative bodies to recapture, stop and prevent release/clearance recycling of radioactive wastes and materials into consumer products and the environment. The petition further supported regulation and isolation of radioactive wastes from nuclear power and weapons and also opposed the use of radioactive materials and wastes in consumer products and building materials including, but not limited to metals, concrete, plastics, glass, paper, wood, soil, and equipment.

The commenter's petition called on the NRC to reverse its efforts and expenditures to release radioactive wastes, to initiate a policy requiring regulatory control and isolation of all radioactive wastes, and demanded the recall of radioactive material and wastes that have been released into the marketplace. The petition also called on DOE to halt all releases of radioactive wastes and materials into the marketplace, to recapture that which has been released, and revocation of the Radioactive Recycle 2000 policy immediately. We acknowledge receipt of the comment; however the comment is not within the scope of this rulemaking.

A commenter stated the proposed rule is too confusing and complicated. We disagree. Although the regulating of radioactive materials involves a degree of technical complexity, particularly because of the need to determine quantities in terms of activity limits and potential exposures, we believe the requirements adopted in this final rule are capable of being understood and complied with. One reason we are allowing an implementation time of one year from publication of the final rule in the

Federal Register

is to allow adequate time for preparation and training for persons responsible for complying with these requirements.

Several commenters stated that over-reliance is placed on unchallenged information of the International Commission on Radiation Protection (ICRP), outdated and incomplete models, lack of information on 350 radionuclides, and a biased scientific opinion on radiation health effects. We

disagree. We believe the ICRP offers a quality and reasonably comprehensive perspective on radiation protection standards. However, during the rulemaking process we do evaluate alternative information and opinions, when submitted to us, which provide reasoned arguments.

Two commenters stated that all the proposals should be withdrawn and that we should adopt public recommendations that improve safety and security and take into account the growth of future radioactive shipments. We disagree. We believe that the proposed rulemaking will improve public safety and is based on projected levels of transportation activities, and that to restart the rulemaking issue would be a public disservice.

Several commenters were opposed to harmonization promulgated by the United Nations and the IAEA. They stated that the international standards-setting process is not democratic, the documents are not freely available, and the deliberations and negotiations are not accessible. The commenters questioned if this process meets the Federal Advisory Committee Act, the Sunshine Act, the Administrative Procedure Act, and the Open Meetings Act. One commenter requested we put interested parties on notice of impending IAEA rulemaking, and receive comments for its consideration as a participant in IAEA's rulemaking process, because neglecting the interests of U.S. stakeholders in the IAEA rulemaking process leaves DOT open to criticism for ill-informed rulemaking that is more in the nature of a legislative fiat from IAEA than a product of the democratic process.

Another commenter stated that although IAEA standards generally have good technical bases, they are consensus standards that do not necessarily consider the risk-informed, performance-based aspects of domestic regulations. Therefore, while most of the IAEA standards should be incorporated into U.S. regulations, the unique aspects of the U.S. regulations need to be considered; the IAEA standards are appropriate for international shipments, but DOT and NRC regulations should also provide allowance for domestic-only applications.

We disagree. We believe that although international agencies, such as the IAEA are not subject to the aforementioned acts, conducting the rulemaking process in accordance with 49 CFR 106, to consider incorporation of their recommendations into U.S. regulations, provides the necessary forum to comply with the Administrative Procedure Act (5 U.S.C. 553). Furthermore, the rulemaking process provides a methodology to deviate from IAEA regulations domestically, where appropriate.

Several commenters generally supported the overall intent of the proposed modifications since a uniform set of requirements for the movement of nuclear materials worldwide is in the public interest for the safe transport of these materials. However, the commenters expressed a concern regarding the slowness of the governmental rulemaking actions. Global businesses are required to comply with the regulations of many countries and many international organizations as well as those of the U.S. during these transitional times, and are therefore forced to operate to two regulatory systems, one for domestic and one for international shipments. This situation places complex demands on management systems, procedures, personnel and training, and for this reason, the commenters stated that the transition to international standards needs to be streamlined so that this impact is minimized more so than is currently the case.

One commenter noted the IAEA two-year cycle is needlessly frequent, resulting in demands on

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