Compatibility With the International Atomic Energy Agency (IAEA)

Federal RegisterSep 28, 1995

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SUMMARY: The Nuclear Regulatory Commission (NRC) is revising the

regulations governing the transportation of radioactive material. The

final rule conforms NRC regulations with those of the International

Atomic Energy Agency, and codifies criteria for packages used to

transport plutonium by air. This action is necessary to ensure that NRC

regulations reflect accepted international standards and comply with

current legislative requirements.

EFFECTIVE DATE: April 1, 1996. Section 71.52 expires April 1, 1999.

ADDRESSES: Single copies of the regulatory analysis for this rule may

be obtained on request from the contact. Copies of the regulatory

analysis may be examined and copied, for a fee, in the Commission's

Public Document Room, at 2120 L Street (Lower Level), NW., Washington,

DC.

FOR FURTHER INFORMATION CONTACT: John R. Cook, Office of Nuclear

Material Safety and Safeguards, U.S. Nuclear Regulatory Commission,

Washington, DC 20555-0001, telephone: (301) 415-8521.

SUPPLEMENTARY INFORMATION:

Background

The U.S. Nuclear Regulatory Commission is revising its regulations,

for the safe transportation of radioactive material to make them

compatible with those of the International Atomic Energy Agency (IAEA)

and to incorporate new criteria for packages used to transport

plutonium by air. The revised rule, in combination with a corresponding

amendment of Title 49, Code of Federal Regulations, by the U.S.

Department of Transportation (DOT), would bring U.S. regulations into

general accord with IAEA regulations (Regulations for the Safe

Transport of Radioactive Material, 1985 Edition, Safety Series No. 6).

The final rule also adopts approval criteria for packages used to

transport plutonium by air. These criteria were developed in response

to Public Law 94. Except for these revisions, NRC's basic standards for

packaging and transportation remain essentially unchanged. These

regulations apply to all NRC licensees who transport, or offer for

transport, byproduct, source, or special nuclear material, and will

help ensure the continued safe transportation of radioactive materials

in domestic and international commerce.

In addition, three Petitions for Rulemaking, concerning the

transportation of Low Specific Activity (LSA) radioactive material, are

denied in this action.

In 1969, the IAEA, recognizing that its international transport

regulations should be revised from time to time on the basis of

scientific and technical advances, as well as accumulated experience,

invited member states to submit comments and suggested changes to the

regulations. As a result of this initiative, the IAEA issued revised

regulations in 1973 (Regulations for the Safe Transport of Radioactive

Material, 1973 Edition, Safety Series No. 6). The IAEA also decided to

periodically review its transportation regulations, at intervals of

about 10 years, to ensure that the regulations are kept current. As a

result, a review of IAEA regulations was initiated, in 1979, that

resulted in the publication of revised regulations in 1985 (Regulations

for the Safe Transport of Radioactive Material, 1985 Edition, Safety

Series No. 6).

On August 5, 1983 (48 FR 35600) NRC published, in the Federal

Register a final revision to 10 CFR Part 71, ``Packaging and

Transportation of Radioactive Material.'' That revision, in combination

with a parallel revision of the hazardous materials transportation

regulations of DOT, brought U.S. domestic transport regulations at the

Federal level into general accord with the 1973 edition of IAEA

transport regulations. Some of the revisions that were eventually

included in the 1985 IAEA regulations were anticipated by NRC and DOT

when they were finalizing their transportation regulations in 1983.

These changes were incorporated in Titles 10 and 49 of the Code of

Federal Regulations at that time.

On June 8, 1988 (53 FR 21550) NRC published a proposed revision to

its regulations in 10 CFR Part 71 in the Federal Register for the

purpose of making U.S. transportation regulations compatible with the

1985 edition of the IAEA regulations. In a parallel rulemaking, DOT

published a proposed revision to its radioactive material

transportation regulations on November 14, 1989 (54 FR 47454). Several

corrections to the NRC proposed rule were published in the Federal

Register on June 22, 1988 (53 FR 23484). Interested persons were

invited to submit written comments and suggestions on the NRC proposal

and/or the supporting regulatory analysis by October 6, 1988. The

public comment period was subsequently extended to February 9, 1990. On

December 8, 1994, the NRC staff provided a briefing on the proposed LSA

requirements and the other revisions at the 416th meeting of the

Advisory Committee on Reactor Safeguards (ACRS). This meeting also

provided industry and the public another opportunity to present their

views on the revisions. Based on the public comments, consultations

with DOT, and other considerations, the Commission is adopting the

proposed rule, with some modifications.

Discussion of Major Changes From Current Requirements

Most of the revisions presented in the proposed rule are being

adopted in the final rule. These include additional hypothetical

accident test criteria for certain types of packages, an increase in

the number of radionuclides with listed A1 and A2 values,

changes in the currently listed A1 and A2 values for some

radionuclides, simplification of fissile material transport classes,

revised requirements for shipment of LSA materials, and inclusion of

criteria for packages used to transport plutonium by air. These changes

are discussed in more detail in the following paragraphs.

Additional Accident Test Requirements

IAEA deep-water immersion and dynamic crush tests are adopted in

the final rule. The 200 meter (656 ft) deep-water immersion test has

been added to the requirements for Type B packages (casks) authorized

for irradiated fuel content in excess of 37 PBq (10\6\ Ci)(Sec. 71.61

Special requirement for irradiated nuclear fuel shipments). The purpose

of the deep immersion test, which can be satisfied through engineering

evaluation or actual physical test (Sec. 71.41), is to ensure that the

cask containment system does not collapse, buckle, nor allow inleakage

of water, if submerged at 200 m (656 ft).

A dynamic crush test (Sec. 71.73(c)(2) Crush) has also been added

to Type B package requirements, for certain lightweight packages that

are minimally vulnerable to damage in the 9 m (30 ft) drop test, but

which have a high potential for radiation hazard, if package failure

occurs. IAEA regulations require the crush test in place of the 9 m (30

ft) drop test, for these packages. NRC is requiring both the crush test

and drop test, for lightweight packages, to ensure that package

response to both crush and drop forces is within applicable limits.

These requirements only apply to package designs certified after

this final

[[Page 50249]]

rule becomes effective. Further, this rule does not apply to packages

fabricated under previous versions of Part 71; however, previously

fabricated packages are subject to multilateral approval, when used for

international transport (Sec. 71.13(b)).

Expansion of Radionuclide List and Changes in Radionuclide Limits

Table A-1, in 10 CFR Part 71, Appendix A, lists the Type A package

quantity limits (A1 and A2 values) for many radionuclides.

The final rule increases the number of radionuclides listed, from 284

to 378. The final rule also adopts the revised A1 and A2

values contained in the 1985 edition of the IAEA regulations. As a

result, 144 A1 values previously listed in Table A-1 are being

increased, and 73 are being decreased, while 129 A2 values are

being increased, and 95 decreased. In addition, the final rule modifies

the method used to determine A1 and A2 values for unlisted

radionuclides.

Simplification of Fissile Material Classes

The final rule revises the criteria for shipment of fissile

material. Specifically, the rule eliminates the three fissile class

designations currently used establishes a single set of criteria for

all packages of fissile material, uses the transport index as the

primary control for the number of fissile packages that may be

transported together, and requires special arrangements for fissile

packages that do not meet the established criteria.

Inclusion of Criteria for Air Shipment of Plutonium

The final rule amends Part 71 to include approval criteria for

packages used to transport plutonium by air (Secs. 71.64, 71.74, and

71.88). These criteria were developed as a result of Pub. L. 94-79,

which prohibited NRC from licensing the air shipment of plutonium, in

any form, until NRC certified to the Congress that a safe container had

been developed. The NRC subsequently developed and certified package

criteria to Congress and published the criteria in NUREG-0360,

Qualification Criteria to Certify a Package for Air Transport of

Plutonium, dated January 1978. This final rule incorporates these

criteria. There are no corresponding criteria in IAEA regulations.

Modifications From Proposed Rule

The final rule differs from the proposed rule in several

significant respects and are described as follows:

1. Package limit for Shipment of LSA and Surface-Containment-Object

(SCO) Material. In its 1985 regulations, the IAEA added a limit of 10

mSv/hour (1 rem/hour) at 3 meters for the radiation level from the

unshielded contents of LSA and SCO (Surface Contaminated Object)

packages not designed to withstand accidents. This radiation level

limit controls the external radiation exposures to individuals if an

LSA package is severely damaged in a transportation accident.

The IAEA limit considers the loss of package shielding during an

accident but it does not consider the possibility that a package's

contents might be released and redistributed, causing a reduction in

self-shielding of the contents. The reduction in self-shielding could

result in potential accident radiation levels that significantly exceed

IAEA's 10 mSv/hour (1 rem /hour) at 3 meters limit.

The IAEA dose rate limit provides a significant added degree of

protection over the 1973 IAEA regulations (which specify no quantity

limit for LSA packages). NRC and DOT did not believe, however that the

IAEA limit provided the same level of safety for all types of LSA

material, particularly for relatively large quantities of radioactive

materials contained in dispersible LSA materials (e.g., resins and

other media used in liquid radioactive waste treatment).

In lieu of the radiation level limit, DOT and NRC proposed a

2A1 quantity limit for all LSA packages. Although this proposal

addressed the accident concern by directly limiting package quantity,

it was not compatible with the IAEA provisions. Both agencies received

many comments from industry on the proposed 2A1 quantity limit

that objected to the impacts on occupational dose and shipping costs.

Further, after a briefing on the draft final rule on December 8, 1994,

the Advisory Committee on Reactor Safeguards (ACRS) issued a letter

report, dated December 19, 1994, recommending, inter alia, that the

requirements again be reevaluated with the objective of making them

equivalent to the IAEA regulations.

After consideration of comments from ACRS and industry, DOT and NRC

have agreed to adopt the IAEA LSA provisions. Accordingly, the final

rule imposes a limit on the external radiation level at 3 meters from

the unshielded contents of LSA-II, LSA-III, or SCO-II packages of 10

mSv/hour (1 rem/hour) (Sec. 71.10(b)).

2. The final rule delays imposing the LSA package external

radiation level limit for 3 years. The effect of imposing the LSA

package limit is to reduce the quantity of LSA materials that can be

transported in non-Type B, LSA packages. The final rule may increase

demand for Type B packages, and there are very few currently available.

NRC had proposed a 1 year delay in implementing the new LSA rules.

Industry comments expressed the view that 1 year is not an adequate

period of time to design a package, have it approved by NRC, and

manufacture a reasonable number of Type B waste packages. NRC agrees,

and has included a delay of 3 years from the effective date of this

rule for implementation of this provision of the final rule

(Sec. 71.52).

3. The proposed rule would have adopted 2A1 as the threshold

below which licensees are exempt from NRC requirements for packages

containing LSA material (except for Secs. 71.5, 71.88 and 71.53).

Because NRC and DOT are adopting the IAEA LSA package limit, the final

rule changes the exemption threshold to 1 rem/h at 3 m

(Sec. 71.10(b)(2)). Thus, designs for packages used to ship LSA or SCO

in quantities where the external dose rate exceeds 1 rem/h at 3 m from

the unshielded material will be subject to NRC Type B package

regulations. Package designs for lesser quantities of LSA or SCO will

be self-certified, by package designers, as meeting applicable DOT IP-

1, IP-2, IP-3, Type A, or strong tight, package regulations. [Licensees

should note that DOT has prescribed, in its final rule, the use of IAEA

Industrial Packages (IP-1, IP-2, and IP-3) for LSA and SCO material.

For domestic transportation only, DOT also provides for the use of Type

A, and strong tight, containers.]

4. For compatibility with IAEA and DOT requirements, a new,

``Sec. 71.77 Qualification of LSA-III Material,'' has been added to

Subpart F. This section prescribes assessment of LSA-III material

leaching. (In the proposed rule, Sec. 71.77 contained ``Tests for

special form radioactive material.'' Those requirements have been moved

to Sec. 71.75 ``Qualification of special form material,'' in the final

rule.)

Other Administrative Actions

The final rule corrects numerical errors in Secs. 71.20(b)(3) and

71.24(b)(4) of the current rule (Secs. (71.20(c)(3) and 71.24(c)(4),

respectively, of the proposed rule). These errors, which were not

identified at the time the proposed rule was published, resulted when

the limit for graphite was expressed as an atomic ratio, instead of a

mass ratio. The errors were inadvertently adopted, in Part 71, during a

rulemaking in 1983, to make

[[Page 50250]]

NRC regulations compatible with 1973 IAEA transportation regulations.

IAEA has subsequently corrected these errors in the 1985 edition of its

transportation regulations.

Section 71.20(b)(3), as currently written, limits the mass of

graphite to ``* * * 150 times the total mass of uranium-235 plus

plutonium.'' Section 71.20(c)(3), in the final rule, would be amended

to read as follows: ``The total mass of graphite present does not

exceed 7.7 times the total mass of uranium-235 plus plutonium.''

Section 71.24(c)(4) would be similarly revised to change the limits on

graphite from 150 to 7.7 times the total mass of uranium-235 plus

plutonium.

NRC is correcting these errors in this final rule. The affected

sections may bear on the criticality safety of fissile materials in

transport. In addition, these corrections are expected to have minimal

impact because there are no shipping casks currently being used that

were designed using the erroneous provisions.

Summary and Resolution of Public Comments

There were 171 letters of comment received on the proposed rule

from industry, State, and local governments; environmental

organizations; medical facilities; and members of the public. A

discussion of general comments is presented below, followed by

responses to comments on specific sections of the proposed rule.

One of the most frequent comments noted differences among NRC, DOT,

and IAEA definitions and requirements where there were no reasons for

the differences. Many of the differences between NRC and DOT

requirements resulted from the long period of time between publication

of the NRC proposed rule (June 8, 1988) and publication of the DOT

proposed rule (November 14, 1989; 54 FR 47454). The two proposed rules

were intended to be published on or about the same date but

circumstances did not permit concurrent publication. Between

publication of the NRC and DOT rules, IAEA published a complete set of

minor changes and changes of detail to its regulations. These changes

were not contained in the NRC proposed rule, but were introduced in the

DOT proposed rule. In addition, a large number of printing errors

appeared in the text of the NRC proposed rule. Only the most

significant errors were rectified in a correction notice published June

22, 1988 (53 FR 23484). The remaining inconsistencies have been

corrected in the final rule.

Another frequently raised comment was in response to NRC's

inclusion of new criteria for the air transportation of plutonium. Out

of 171 total letters of comment on the proposed rule, 119 of those

letters were concerned with the single issue of air transportation of

plutonium. In general, these letters requested that NRC codify the

NUREG-0360 criteria for the safe air transportation of plutonium,

notwithstanding urging by the U.S. Department of Energy (DOE) that NRC

withhold codification until it could consider rules being developed by

IAEA for the safe air transportation of plutonium. Many of these

letters, primarily from residents of Alaska, attributed development of

the NUREG-0360 1 criteria to U.S. Senator Frank Murkowski.

However, the criteria in NUREG-0360 were developed by the NRC in

response to Public Law 94-79, enacted in 1975. (Senator Murkowski

sponsored much more recent legislation on transportation of plutonium

by air, identified as Section 5062 of Public Law 100-203, for which

regulatory criteria have not been developed.) NRC has relied on the

NUREG-0360 criteria for plutonium transportation by air since the

criteria were published in 1978. DOE's request that NRC withhold the

codification of the NUREG-0360 criteria while NRC considers the IAEA

alternative cannot be accommodated because there is no existing IAEA

alternative to consider and none is expected for several years.

Although the IAEA development process has begun, the process is long

and multifaceted. Predictions as to final content of an IAEA

alternative cannot be made at this time. It also should be noted that,

under Public Law 94-79, the proposed criteria would apply to any U.S.

import, export, or domestic plutonium air transport regardless of IAEA

regulations. Accordingly, the plutonium air transport criteria are

incorporated in the final rule.

\1\ Copies of NUREG-0360 may be purchased from the

Superintendent of Documents, U.S. Government Printing Office, P.O.

Box 37082, Washington, DC 20013-7082. Copies are also available from

the National Technical Information Service, 5285 Port Royal Road,

Springfield, VA 22161. A copy is also available for inspection and

copying for a fee in the NRC Public Document Room, 2120 L Street,

NW. (Lower Level), Washington, DC.

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Section 71.0 Purpose and Scope

One comment suggested that Sec. 71.0 (a) could be clarified by

referring to the need for a Type B package rather than to licensed

material in excess of a Type A quantity. Section 71.0 (a)(2) would then

read ``Procedures and standards for NRC approval of packaging and

shipping procedures for fissile material and for other licensed

material required by this Part to be transported in a Type B

packaging.''

Although the suggested wording may be a good description of Part

71, Fissile Type A packages are still subject to NRC approval.

Therefore a scope based on quantity of radioactive material is better

than a scope based on a single type of package.

Section 71.4 Definitions

One comment noted that the term ``licensed material'' is used in

Part 71, in several locations, but is not defined in Part 71. In

response to this comment, NRC has added the definition of ``licensed

material,'' as codified in 10 CFR Part 39, to the definitions in Part

71. The term ``licensed material'' only includes radioactive material

licensed by the NRC. One comment noted that in defining the term

``exclusive use,'' the parenthetical note ``* * * also referred to in

other regulations as `sole use' or `full load' '' is no longer

necessary. Those other terms have been almost completely phased out,

and IAEA has eliminated the clarifying note. NRC agrees and also has

eliminated the clarifying note.

One comment noted that the definition of ``exclusive use'' requires

that loading and unloading be performed by personnel having

radiological training and resources appropriate for safe handling of

the consignment. However, the definition provides no criteria to

indicate what that training should be. NRC believes this is an area

where the regulation includes a sufficient level of detail to define

the intent of the provision. NRC further notes that DOT has established

requirements for hazardous material employee training (see 49 CFR Part

172, Subpart H, Secs. 172.700-172.704, effective July 2, 1992).

One comment suggested that the term ``transport index'' specify

that the number be rounded up ``to the next tenth'' rather than ``to

the first decimal place.'' NRC believes that either terminology is

adequately clear, and is retaining the original wording for uniformity.

This wording has been used satisfactorily over a number of years.

One comment suggested that the ``Natural uranium'' definition

should be clarified to indicate that the phrase ``the remainder being

uranium-238'' refers strictly to a weight basis, not to a radioactivity

basis. NRC has made the clarification.

One comment raised the question whether ``licensee'' and ``licensee

of the Commission'' are synonymous, and whether the terms include

``persons

[[Page 50251]]

licensed by an Agreement State,'' so that the general licenses of

Secs. 71.12-71.24 could apply. NRC asserts that the terms ``licensee''

and ``licensee of the Commission'' are synonymous. For uniformity, the

NRC has eliminated the longer of the two terms in the final rule.

Neither term includes Agreement State licensees. However, Agreement

State licensees engaging in activities in non-Agreement States, or in

offshore waters, under the reciprocity provisions of 10 CFR Part 150,

``Exemptions and Continued Regulatory Authority in Agreement States and

in Offshore Waters under Section 274,'' are subject to the requirements

of 10 CFR Part 71. In such instances, the NRC general licenses

mentioned above apply to Agreement State licensees.

One comment noted that the term ``specific activity'' should only

be used when describing the radioactivity of a radionuclide per unit

mass of the element. When describing the radioactivity per unit mass of

a material in general, the comment suggested the use of the words

``concentration of radioactivity.'' NRC has been unable to confirm any

preferred limited use of the term ``specific activity,'' and, in view

of the years of successful international use of the term in its broader

sense, plans to continue that broader use.

One comment noted that the NRC and DOT definitions of ``exclusive

use'' are not identical, and that the DOT definition appears

preferable. In the final rules promulgated by NRC and DOT, the

definitions of ``exclusive use'' are identical.

One comment noted a difference in quantities, for DOT's proposed

rule ``highway route controlled quantities,'' in 49 CFR 173.403, and

for NRC's ``advanced notification of shipment of nuclear waste''

requirements in 10 CFR 71.97. The limits were intended to be the same.

As the comment suggested, the error (by NRC) was caused by the rounding

of the International System (of units) (SI) and customary units and has

been corrected in this final rule.

Section 71.4 Definitions (Dual Unit System--The International System

of Units Followed or Preceded by U.S. Standard or Customary Units).

Ten comments suggested both support for the dual unit system used

in both NRC and DOT proposed regulations and potential problems that

might result from a dual unit system. Several other comments suggested

that NRC and DOT be consistent in the use of units. NRC and DOT intend

to use dual units in specifying the regulatory requirements. The

introductory language to Sec. 71.4 states that the different units are

functionally equivalent and can be used interchangeably for purposes of

this part. There are no paperwork requirements in Part 71 (e.g.,

records, reports) where the mandatory use of units is specified. DOT

regulations also specify regulatory requirements in terms of dual

units. In 49 CFR 171.10, DOT specifies that the SI units are intended

to serve as the standard, but that the customary units (rounded) are

included to provide a functionally equivalent limit. The dual unit

approaches used by NRC and DOT are compatible.

In addition, DOT specifies, in 49 CFR Part 172, the units that must

be used to satisfy the communication standards for shipping papers and

package labels. Sections 172.203(d)(4)and 172.403(g)(2) require that

shipping papers and package labels be completed either in SI units

alone or in SI units and customary units. These requirements also

permit, for a period of one year after the effective date of the final

rule, the use of customary units on shipping papers and package labels

for domestic shipments only.

One comment noted that the double conversion from customary units

to SI units, and back to customary units produces specifications that

are out of line with standard material sizes. For example, a test with

what was a standard 6-inch-diameter mild steel bar, with an edge radius

of \1/4\ inch, was proposed as a test with a 5.91-inch diameter mild

steel bar, with an edge radius of 0.236 inch. The converted customary

units of length and weight have been returned to their original values

in the final rule.

One comment suggested greater consistency of units between the NRC

and DOT transportation regulations and the Commission's ``Standards for

Protection against Radiation'' in 10 CFR Part 20. Since the NRC and DOT

transportation rules were proposed, NRC has revised 10 CFR 20.1004,

``Units of Radiation Dose,'' and 10 CFR 20.1005, ``Units of

Radioactivity,'' to permit the use of either customary or SI units,

These revisions achieve greater consistency of units among

transportation and radiation protection regulations.

One comment noted that differences between IAEA and Part 71 A

values (expressed in conventional units) may cause problems in

international transport. The curie values in Safety Series #6, Table I

are approximate, rounded down from the TBq values after conversion to

Ci, whereas the curie values in Table A-1 Part 71 are converted from

the TBq values to three significant figures without rounding down. The

Part 71 method was used because it yields values that more closely

approximate previous Table A-1 values. As noted earlier in this

preamble, DOT regulations will require the use of the SI units in

shipping papers and labels for international shipments (although

conventional units may be used in addition to the SI units). The use of

SI units should retain consistency with the IAEA regulations.

One comment suggested that the term ``transport index'' be defined

using both customary and SI units, as IAEA has done. The proposed

definition was expressed only in customary units. NRC agrees with this

suggestion and has adopted the DOT definition of ``transport index''

which includes both customary and SI units.

Section 71.4 Definitions (LSA and SCO in Particular)

Several comments related to clarification of LSA definitions.

Two comments noted the typographical error in the proposed rule in

which the ``water with tritium'' concentrations for LSA-II were printed

as 27.0 Ci/ (1 TBq/), rather than as 27.0 Ci/l (1

TBq/l). Two other comments noted that the numerical values differed

from those in the DOT proposed rule (20 Ci/l and 0.8 TBq/l,

respectively). One comment stated a preference for the 27.0 Ci/l limit.

NRC values in the proposed rule were derived from the IAEA and DOT

values by rounding up the terabequerel limit and then converting to

curies. For consistency, NRC has adopted the IAEA and DOT values in the

final rule.

Three comments were concerned with the definition of LSA-I. The

first comment noted that material generated from the extraction of

uranium or thorium was not classified into any LSA category. The

comment recommended an LSA-I classification for this material. Another

comment recommended that the term ``contaminated earth'' in LSA-I be

expanded to include ``soil, earth, concrete rubble, and other bulk

debris.'' A third comment expressed concern that mill tailings

exceeding 10-6 A2/g could not be shipped in bulk under the

proposed rule. The comment recommended that either mill tailings be

specifically included in the definition of LSA-I without an activity or

concentration limit, or the specific activity limit for LSA-I be

increased to 4x10-6 A2/g.

NRC agrees that ore-like materials (materials with highly uniform

distribution of small quantities of radionuclides) should be

transported as LSA-I material. Accordingly, the definition of LSA-I has

been changed from ``contaminated earth * * * `` to

[[Page 50252]]

``contaminated earth, mill tailings, concrete rubble and other bulk

debris * * *'' Further, NRC believes that mill tailings will meet the

proposed 10-6 A2/g specific activity limit, and therefore has

not increased the limit.

Two comments suggested that NRC include a definition of the term

``closed transport vehicle'' used in the definition of LSA-I. This term

has been removed from the definition of LSA-I because NRC and DOT

concluded the use of a vehicle-based term in the definition of a

material was inappropriate. ``Closed transport vehicle'' is defined in

DOT's rule (49 CFR 173.403(c)).

One comment suggested that LSA-II material definition be expanded

to include activated materials, consolidated wastes, and materials

intrinsically contained in a relatively insoluble matrix. LSA-II is

expected to include primarily unsolidified material in which the

radioactive material may or may not be uniformly distributed, including

lesser activity resins and filter sludges, other similar materials from

reactor operations, similar materials from other fuel cycle operations,

scintillation vials, and hospital, biological, and decommissioning

wastes. There is, however, no prohibition against activated materials,

consolidated wastes, and materials intrinsically contained in a

relatively insoluble matrix in group LSA-II, provided the specific

activity limit is met. The IAEA established the LSA-III group

principally for irradiated reactor parts and other activated, or

activated and contaminated, equipment that exceed the limits for the

other LSA groups. NRC does not believe it is necessary to expand the

LSA-II group definition to include these materials. The NRC believes

that to do so might cause confusion with the LSA-III definition.

One comment stated that dewatered material should be defined as a

solid for LSA-II. NRC agrees that dewatered resins should be subject to

the specific activity for solids under LSA-II and notes that there is

no prohibition against dewatered resins in LSA-II.

One comment asked whether the specific activity limits for LSA-II

and LSA-III materials were pre- or post-solidification. The specific

activity limits apply to materials as prepared for shipment, i.e.,

post-solidification. However, licensees should note that packaging or

shielding material may not be considered in determining either the

specific activity or the radiation level at 3 m.

One comment recommended that NRC remove the criterion for leaching

that is applicable to LSA-III solids. The criterion limits the loss of

radioactive material per package, when the package is placed in water

for 7 days, to 0.1 A2. Another comment stated that the criterion

for leaching in the definition of LSA-III needed to be compatible with

the leachability index requirements for solidified waste in 10 CFR

Parts 60 and 61.

A control on the potential intake of these LSA-III materials is

necessary because the radioactivity is not entirely insoluble. Because

non-Type A packaging might be used in transporting these materials, a

release of 10-2A in an accident is assumed, with a possible

bystander uptake of 10-3 A2, under the standard model for

determining A2 values. Because the total body uptake must be

limited to 10-6 A2, the package's dispersible radioactive

contents (i.e., the leachate liquid), must not exceed 0.1 A2. For

purposes of compatibility with IAEA and DOT requirements, a new

Sec. 71.77, ``Qualification of LSA-III Material,'' has been added to

Subpart F. This section prescribes testing requirements for assessment

of LSA-III material leaching. The hazard from the transportation of

these materials is different from that posed by their disposal;

therefore, no attempt has been made to achieve compatibility between

transportation and disposal leachability limits.

One comment found the proposed rule unclear on the need for three

LSA categories and how to classify materials under the criteria,

including compacted dry active waste. IAEA developed the three LSA

groups to differentiate controls based on the activity, distribution,

and form of LSA material. The LSA-I group accommodates very uniformly

distributed materials, such as ores. LSA-III accommodates large

activated parts or solidified materials. LSA-II accommodates less

uniformly distributed materials, such as compacted dry active waste.

One comment described radioactive atoms in activated products as

inherently non-dispersible and relatively non-leachable. The comment

recommended that activated materials be authorized for shipment as LSA-

I, provided other transportation requirements are met. Although

activated materials do not pose a dispersibility hazard, these

materials are subject to localized concentrations of non-uniformly

distributed material. Consequently activated materials are included in

groups LSA-III and LSA-II.

One comment suggested changing the definition of SCO from ``* * *

not itself radioactive * * *'' to ``* * * not classed as radioactive

material under these rules * * *,'' since nothing is free of

radioactive material. NRC and DOT have adopted this comment.

Several comments identified a typographical error in the limit for

non-fixed contamination from beta and gamma emitters on the accessible

surface of SCO-I objects. That value has been changed from 1.08 x

10-5 Ci/cm \2\ to 10-4 microcurie/cm \2\. These comments also

noted inconsistencies in the NRC and DOT contamination limits e.g.,

(1.08 x 10-4 Ci/cm \2\ and 10-4 microcurie/cm \2\,

respectively). NRC has adopted the DOT convention for these limits in

the final rule.

One comment inquired as to whether it was consistent for NRC not to

exempt SCO-I from transportation requirements when facilities with

similar contamination levels may be released for unrestricted use

according to NRC Regulatory Guide 1.86. Under the final rule, SCO-I

group materials are exempt from NRC regulations, except for one

Sec. 71.5 requirement that licensees comply with DOT requirements.

Further, the SCO-I non-fixed surface contamination limits are greater

than, not similar to, the corresponding acceptable surface

contamination levels in Table 1 of NRC Regulatory Guide 1.86.

Several comments noted that the term ``inaccessible surface'' used

in the SCO-I definition is not defined and that it was not clear how to

comply with a limit for surfaces that were inaccessible. This provision

provides for the disposal of materials that have contaminated surfaces

that are not readily accessible. Examples of inaccessible surfaces

include: inner surfaces of pipes, inner surfaces of maintenance

equipment for nuclear facilities, and inner surfaces of glove boxes.

Compliance can be achieved by sampling a small area of the surface that

may be accessible or by a documented estimate of the inaccessible

surface contamination.

One comment stated a belief that the implementation of SCO groups

would: (a) Further complicate the preparation and shipment process,

without an increase in the safety and quality of waste shipments; (b)

result in a significant increase in personnel exposure costs, and

delays for preparation and disposal of radioactive waste; (c) require

substantial initial personnel training; and (d) require extensive

revisions of existing procedures and waste shipping computer programs.

NRC acknowledges that the introduction of multiple LSA and SCO groups

complicates the transportation of LSA materials. The IAEA consensus was

that it was appropriate to regulate SCO separately from LSA materials.

The purpose of

[[Page 50253]]

these groups is to recognize the lesser hazard of LSA and SCO relative

to other radioactive materials, and to provide relief from shipment

requirements that would otherwise apply to these materials, while still

assuring safety.

With regard to exposure, it is true that the LSA groups will

require some increased material treatment or handling. However, this

handling is necessary to eliminate the current practice in which there

is no quantity limit on LSA packages. This situation poses a risk to

the public during transport. Costs will increase, but not by an amount

considered significant for the industry. Training with regard to the

LSA groups, or any new provision, will be required. Periodic training

of hazardous material employees regarding the safe transportation of

hazardous materials is required by DOT regulations (49 CFR Part 172

Subpart H); instruction with regard to the LSA and SCO groups may be

included at that time.

Implementing the LSA groups will require revision of procedures and

computer codes. These costs are judged to be acceptable in order to

achieve compatibility with the IAEA regulations for the safe transport

of radioactive materials.

A comment noted that the SCO classification ``appears to be well-

meaning,'' but that the proposed criteria (presumably the proposed

2A1 limit) ``detract from its potential benefit and utility,'' and

that it would be easier and less expensive for both producers and

consumers of electricity to enjoy the benefits of new transportation

systems without the related restrictions. As stated previously, NRC has

adopted the IAEA 10 mSv/h (1 rem/h) at 3 m limit for LSA packages, and

believes that a limit is needed to protect the public from the

potential for excessive external radiation exposure in the case of a

severe transportation accident.

One comment suggested that the rule make clear that not every SCO

needs to be surveyed and that a random representative survey is

adequate. There is no requirement that each SCO in a package be

surveyed. The shipper must be able to demonstrate, however, that the

package contents comply with applicable SCO definitions.

One comment objected to the upper limit for removable surface

contamination for SCO-II (10-2 Ci/cm \2\ for beta and

gamma emitters) because this limit is a factor of 90 less than current

LSA limits, and would require extensive decontamination of reactor

outage equipment at each site. The comment stated such decontamination

is not warranted because it violates the as low as reasonably

achievable (ALARA) principle, and is not justified based on shipping

experience. The comment suggested that an SCO-III group be defined for

materials exceeding SCO-II, and that Type A packaging be required for

such materials.

Apparently, this comment is comparing the SCO-II limit for

removable (non-fixed) surface contamination with the current LSA limit

that applies to nonradioactive material objects that are externally

contaminated with radioactive material that is not readily dispersible.

The SCO-II limit for fixed surface contamination is a more appropriate

comparison with the current limit for not readily dispersible

contamination. The SCO-II fixed contamination limit is 20 times greater

than the current LSA limit for not readily dispersible contamination.

Section 71.5 Transportation of Licensed Material

Two comments asked for clarification of the specification ``* *

*outside of the confines of its plant or other place of use,'' when

describing transportation made subject to DOT regulations. One of those

comments suggested that the provision be reworded as ``* * *outside the

site of usage, as specified in the NRC license, or where transport is

on public highways.'' This wording clarifies the provision and has been

included in the final rule. Similar wording has been substituted in

Sec. 71.0(c).

A comment asked whether Sec. 71.5(b) means ``that an approval must

be obtained when the shipment is covered by local State regulations and

those regulations will be followed.'' The purpose of Sec. 71.5(b) is to

impose, by NRC authority, pertinent DOT requirements on shipments, by

NRC licensees, that are not normally subject to DOT requirements. There

is no exemption from the requirement of Sec. 71.5(b) regarding

compliance with State or local regulations.

Section 71.10 Exemption for Low Level Materials

A comment noted that the SI unit specification of 74 kBq/kg

(0.002Ci/g) for exempted low-level radioactive material in

Sec. 71.10(a) is not consistent with the 70 Bq value specified in the

DOT proposed rule. The specification in Sec. 71.10(a) has been changed

to 70 Bq/g, the value in the DOT's final rule. This exemption is

applicable only with respect to transportation, and is not generally

applicable to other Commission-regulated activities.

A comment noted that it would be useful to have an exemption for

small quantities of radioactive material in Sec. 71.10(a) as well as

the exemption for LSA material. The safety rationale developed by IAEA

2 for LSA material does not extend to other radioactive materials.

IAEA has been informed that a small quantity exemption may be a useful

concept. However, this exemption has not been developed yet.

\2\ International Atomic Energy Agency Safety Series #7--

``Explanatory Material for the IAEA Regulations for the Safe

Transport of Radioactive Material'' (1985 Edition). Available from

Bernam-Unipub, 4611-F Assembly Drive, Lanham, MD 20706-4391. Tel.

(301) 459-7666.

---------------------------------------------------------------------------

One comment asked that NRC clarify the use of a reference to

Sec. 71.53 in the ``Exemption for low-level materials'' provision of

Sec. 71.10(b), a provision that pertains to Type A and LSA packages. In

addition to control over excessive radiation, the Commission's

responsibility with respect to fissile material is to provide

reasonable controls to avoid the occurrence of accidental criticality.

The regulatory standards for this are found in Secs. 71.55 and 71.59.

There are some relatively common types of fissile material packages for

which there is no credible risk of criticality in transport, even in

the absence of controls. These packages are described in Sec. 71.53,

and are exempted from the criticality controls of Secs. 71.55 and

71.59, because the controls are unnecessary.

The provisions of Sec. 71.10, ``Exemption for low-level

materials,'' provide broad exemptions from 10 CFR Part 71 rules that

relinquish to DOT the control of types of shipments that are of low

risk both from radiation and criticality standpoints. To ensure that

only low criticality risk shipments are included in Sec. 71.10(b), NRC

restricts the exemption to Type A and LSA packages that either contain

no fissile material or satisfy the fissile material exemptions in

Sec. 71.53. It should be noted that the exemption does not relieve

licensees from DOT transportation requirements by reason of NRC

authority, nor does the exemption relieve licensees from the

restrictions on air transportation of plutonium imposed by Congress.

The proposed rule introduced a 2A1 quantity limit, for LSA

packages not designed to withstand accidents (non-Type B packages), to

control potential external radiation exposures. Thirty comments were

received requesting that the limit be changed in the final rule. Two

comments supported no limit; nine supported the IAEA dose limit of 10

mSv/h (1 rem/h)r at a distance of 3 meters for an unshielded package; 4

supported higher multiples of A1; and 15 supported the optional

use of either the IAEA limit or a higher multiple of A1. As

described previously in this

[[Page 50254]]

preamble, NRC and DOT have decided that the best overall response on

the LSA issue and these comments is to drop the proposed 2A1

quantity limit, and to adopt the IAEA radiation level limit of 10 mSv/h

(1 rem/h) at 3 m from the unshielded contents.

One comment suggested that the need for labels on LSA packages

should be reconsidered. Package labelling falls under DOT jurisdiction.

In its final rule, DOT has retained the exception from package marking

and labeling requirements for domestic LSA shipments consigned as

exclusive use (see 49 CFR 173.427).

One comment expressed concern over the transition of control of

packages for shipping Type B quantities of LSA radioactive material

from NRC to DOT. NRC has a centralized package design approval

authority, whereas DOT authority allows a shipper to determine

acceptable package designs (i.e., self-certify package designs). The

comment expressed apprehension about permitting each shipper to review

package and shipping restrictions against DOT regulations, a situation

that could result in some confusion and different interpretations of

the regulations.

In the final rule, the IAEA limit of 1 rem/h at 3 m from the

unshielded material contents has been established as the threshold for

NRC regulation of LSA or SCO package designs. NRC will review and

approve, if adequate, designs for packages that contain quantities of

LSA or SCO material that exceed that limit. The review by regulatory

authority of package designs for quantities that exceed the IAEA limit

is consistent with the approach used by other IAEA member states.

Section 71.13 Previously Approved Package

One comment proposed that the date specified in Sec. 71.13(b)(2) be

December 31, 1990, instead of December 31, 1992, to be consistent with

IAEA transportation regulations. The original 1985 IAEA transport

regulations specified December 31, 1990, as the cutoff date for the

routine use of packages manufactured under the 1973 edition of the

regulations. That date was subsequently extended for 2 years by one of

the periodic updates of IAEA regulations and was properly used in the

proposed rule. However, since the proposed date of December 31, 1992,

has passed, the final rule has been revised (by eliminating reference

to any particular date) to make this provision effective on the date

that the final rule becomes effective.

Two comments noted that the preamble to the proposed Part 71

indicated that Type B and fissile packages fabricated before a certain

date and not used internationally could continue to be used

domestically until the end of their useful lives. The licensee would

not need to demonstrate that the packages satisfy the new crush test or

deep-immersion test. The comments would take that provision one step

further and require the crush and deep-immersion tests only for

international use packages.

NRC believes that the international package standards should be

used by the United States for both domestic and international

shipments, to the extent practicable. However, based on a history of

safe use under earlier safety standards, and the absence of unfavorable

operational data, NRC will allow the continued use of existing packages

in domestic transport until the end of their useful lives. NRC will not

allow, however, the continued fabrication of packages to the old

designs. This action permits use of existing packages. It does not

perpetuate package designs that can be discarded or upgraded to satisfy

the new standards.

Another comment suggested grandfathering the existing Type A casks

now approved for transporting Type B quantities of LSA radioactive

material, until the Type B waste casks required to satisfy the new

standards become available. NRC has adopted the suggestion, extending

the proposed provisions in Sec. 71.52, ``Exemption for low-specific-

activity (LSA) packages,'' to a 3 year period, to give the industry

time to design, receive approval, and fabricate new Type B waste

packages.

Section 71.22 General license: Fissile Material, Limited Quantity,

Controlled Shipment

One comment requested clarification as to whether the Type A limit

imposed in Sec. 71.22(c) also applies to Sec. 71.22(d).

The requirements of Secs. 71.22(a) through 71.22(e) are cumulative,

each imposing additional requirements on the use of the general

license. The radioactivity limit and mass limits of Sec. 71.22(c) apply

to packages, whereas the mass and mass ratio limits of Sec. 71.22(d)

apply to shipments.

A comment noted an error, in Sec. 71.22(d)(3), which changed the

intent of the section. The commenter suggests that the phrase ``exceeds

unity'' at the end of Sec. 71.22(d)(3) be replaced by the phrase ``does

not exceed unity.'' NRC agrees and has made that change.

Section 71.24 General License: Fissile Material, Limited Moderator,

Controlled Shipment

One commenter asked if the statement in Sec. 71.24(b), ``* * * a

quality assurance program approved by the Commission as satisfying the

provisions of Subpart H of this part,'' is any different from ``* * * a

quality assurance program approved by the Commission.'' The two

statements are different in that the first is more specific and

provides more detail. There are several different quality assurance

programs, in different licensing areas, approved by the Commission.

Specifying that the program must satisfy Subpart H makes it clear as to

the type of quality assurance program is required.

One commenter recommended inserting ``by weight'' after ``1

percent'' in Sec. 71.24(c)(6). NRC agrees and has made this change in

Sec. 71.24(c)(7), as well.

With respect to a general license for a package containing fissile

contents, one commenter requested clarification of what is meant by

``no uranium-233'' in Sec. 71.24(c)(6). For a general license under

Sec. 71.24(c)(6), a package containing fissile contents must have no

detectable U-233. The method for making this determination can be

decided by the licensee. For example, the licensee can make this

determination by performing an assay or by knowing the history of the

material.

Subpart D--Application for Package Approval

One comment suggested changing the title of Subpart D to

``Application for Type B Package Approval'' for clarity. Because NRC

also approves Type A packages for fissile material, the title of

Subpart D continues to refer to ``Package Approval.''

Section 71.38 Renewal

One comment suggested that NRC provide some administrative

acknowledgment when a timely application for renewal of a certificate

of compliance has been received to provide proof that timely renewal is

in effect. The Commission does not believe that proof of timely renewal

is particularly important and that providing an acknowledgment to each

registered user of a package would be too burdensome for the benefit

gained.

Section 71.43 General Standards for All Packages

Four comments suggested the addition of IAEA regulations relating

to packaging of liquids and gases to Part 71, including those

pertaining to the special free drop and penetration tests

[[Page 50255]]

for liquids and gases. The NRC approves only Type B and fissile

material packages. The NRC also notes that fissile material packages

must be evaluated for hypothetical accident conditions more severe than

the tests for liquids. Furthermore, there are currently no NRC-licensed

packages designed for gaseous fissile materials and NRC does not

anticipate any future applications for such packages. These additional

provisions would complicate regulations that are presently adequate.

IAEA standards on absorbent material and double containment have been

selectively included in DOT regulations.

Eight comments disagreed with the NRC view that Sec. 71.43(f)

should continue to restrict to ``no significant increase'' any change

in external surface radiation levels, as a result of subjecting a

package to the defined normal conditions of transport. The comments

argued that the 20 percent increase specified in IAEA regulations is a

safe, reasonable, and practical number that could not reasonably be

lower, and that specifying a value in the rule provides the package

design engineer and the NRC review engineer a measurable goal that is

consistent both with IAEA and with engineering practice.

Type B and fissile material packages can be readily designed so

that normal conditions of transport result in no significant increase

in dose rates, and that a twenty percent increase in dose rates because

of normal handling is excessive. In addition, if a package were

designed so that the external dose rate could increase 20 percent

during normal handling, the package could exceed the dose rate limits

in Sec. 71.47 during transport, and would be an item of non-compliance.

NRC and DOT have therefore decided to not adopt the IAEA ``20 percent

increase'' provision, and to retain the current ``no significant

increase'' provision.

Four comments suggest the addition of the special provisions of

IAEA regulations pertaining to the transportation of radioactive

material by the air mode. NRC has determined that special requirements

for transport of packages by air should be excluded from Part 71

because these provisions are properly incorporated in the carrier

restrictions imposed by the Department of Transportation.

Two comments suggested that the phrase ``Account must be taken of

the behavior of materials under irradiation'' be clarified and

quantified, perhaps in a regulatory guide, or deleted from Part 71.

Although there is no regulatory guidance now available relating this

requirement to transportation packages, it is clear that any effects of

irradiation on materials used in the package must be taken into

account. These effects could be the accelerated aging or embrittlement

of elastomers or elastics and may result in requiring a frequent change

of gaskets, for example.

One comment suggested the performance requirement of Sec. 71.43(f)

be changed to include a numerical sensitivity for the requirement that

there be ``no loss or dispersal of radioactive contents'' as a result

of subjecting a package to the specified normal conditions of

transport. The equivalent paragraph in the IAEA regulations for Type A

packages is paragraph 537, and does not contain a numerical

sensitivity. Paragraph 548, of IAEA Safety Series #6, is the equivalent

of 10 CFR 71.51, for Type B package leaktight sensitivity. Both those

provisions require Type B packages to be leaktight to a sensitivity of

10-6 A2/h.

Three comments noted that IAEA no longer prohibits continuous

venting of packages in its 1985 edition and urged the NRC to allow the

practice domestically for Type B packages. The commenters argued that

although NRC took a strong position, in the preamble to the proposed

rule, that continuous package venting is ``poor engineering practice,''

NRC did not explain why. The commenters noted that DOT regulations do

not prohibit continuous venting for Type A packages, leaving the

acceptability of continuous venting to be decided by performance

requirements. The commenters stated that in some cases it would make

good sense to allow continuous venting to provide pressure equalization

and discharge of organically generated hydrogen gas.

NRC is continuing its ban on continuous venting of Type B packages

for the following reasons:

1. Venting of a package containment system during normal conditions

of transport defeats the purpose of the containment system;

2. It is practical to design packages that do not rely on venting,

to relieve pressure under normal conditions of transport;

3. The use of a vent does not necessarily prevent the generation of

potentially flammable or explosive gas mixtures; and

4. The reliability of filters under temperature extremes, varied

operating conditions, and sustained service has not been established.

Two comments stated that Mo-99/Tc-99m radiopharmaceutical

generators are open to the atmosphere to allow changes in ambient

pressure and that the generators do not vent radioactive material. The

comments recommended that the prohibition against venting be limited to

venting radioactive material only and that NRC continue current

practices.

NRC believes these comments arise from concern over the reduction

in the A2 quantity for Mo-99 from 20 curies to 13.5 curies in the

proposed rule. NRC recognizes that the shipment of Mo-99/Tc-99m

generators is a special case, and is retaining the 20 curie A2

value for Mo-99, to permit the continuation of current practices.

Section 71.47 External Radiation Standards for All Packages

NRC used the term ``accessible external surface'' in its proposed

rule for determining radiation levels on package surfaces, whereas DOT

used the term ``external surface'' in its proposed rule. Four comments

argued that the NRC and DOT regulations for radiation level limits on

package surfaces should be identical. Most believed that a limit on

accessible surfaces was the more reasonable standard.

DOT has indicated that it is considering a petition for rulemaking

to add the word ``accessible'' to its radiation level regulations and

will consider that complex issue in a separate action. Pending

completion of the DOT separate action, NRC has deleted the word

``accessible'' from this section of the final rule but does not intend

to alter its practices regarding this provision.

One comment stated that this paragraph tends to be confusing in

that it establishes a limit of 2 mSv/h (200 mrem/h) for package surface

radiation levels, yet Sec. 71.47(b)(2) seems to state that packages

transported on a flatbed trailer can exceed 2 mSv/h (200 mrem/h),

provided the radiation level at the planar edges of the trailer is less

than or equal to 2 mSv/h (200 mrem/h).

Section 71.47 establishes a generally applicable 2 mSv/h (200 mrem/

h) Package surface radiation-level limit. The section further

establishes that, if a package is shipped as exclusive use, the

radiation level may exceed 2 mSv/h (200 mrem/h), provided the

applicable provisions of paragraphs (a) (with repect to Transport

Index) through (d) are met. Paragraph (b)(2) restricts the radiation

level at any point on the vertical planes projected by the outer edges

of a flat-bed style vehicle to 2 mSv/h (200 mrem/h) (the same limit

imposed in paragraph (a) for the outer surfaces of closed transport

vehicles). Thus, provided packages are shipped as exclusive use,

external radiation levels may exceed 2 mSv/h (200 mrem/h) at the

surface of packages on flatbed trailers, but not at the outer-edge

planes of the vehicle.

[[Page 50256]]

Section 71.51 Additional Requirements for Type B Packages

One comment suggested that the clarifying provision following

paragraphs 548(a) and (b) of IAEA regulations be added to Part 71 for

consistency. The clarifying provision pertains to allowable releases of

radioactive material from a package containing a mixture of

radionuclides. This is the case, for example, with spent nuclear fuel

casks. That clarifying provision has been added.

Section 71.52 Exemption for LSA Packages

Twelve comments expressed concern that the proposed Part 71 affords

only a 1-year delay in applying the new LSA rules. NRC established the

1-year delay to give the industry an opportunity to design and build

the Type B waste casks that would be required under the new rules. The

comments uniformly argued that 1 year was not a sufficient period of

time to design a waste cask, to have it reviewed and approved by NRC,

and to fabricate an adequate number of casks, to approved designs, that

satisfy the needs of the new LSA rule. The commenters differed in how

long they thought that process would take, varying over 2, 3, and 5

year periods. NRC agrees with the thrust of this comment and has

established the exemption period at 3 years. Thus existing packagings

may be used for 3 years and new packagings may be fabricated from

existing designs for 3 years.

A consequence of establishing the IAEA LSA/SCO package limit as the

delineator between NRC and DOT regulation of LSA and SCO packaging [see

Sec. 71.10(b)(2)] is that, after the 3 year exemption period, LSA will

be shipped either in DOT authorized packagings, or in NRC certified

Type B packagings. Accordingly, NRC is discontinuing the practice of

certifying Type A LSA packages. NRC has therefore not adopted a

proposed exemption (Sec. 71.52(a)) that only would have applied to NRC

certification of new Type A LSA package designs.

One comment stated that the demand for waste casks would rise until

1993 and then fall again because few of the low-level radioactive waste

disposal site compacts will permit disposal access. Vendors will

hesitate to invest in casks that will not be used after 1993 and waste

will need to be stored onsite.

NRC is unwilling to accept this proposition and believes that as

long as NRC specifies the requirements for transportation of waste,

given adequate time, industry will continue to develop disposal

options.

One comment argues that the specific reference to Sec. 71.43(f)

should be deleted because it is included in the broader reference to

Secs. 71.41-71.47.

Section 71.52 exempts exclusive use LSA and SCO packages from the

additional requirements for Type B packages for a period of 3 years

from the effective date of the final rule. These LSA packages are still

subject to other requirements that apply to all packages. The referral

to these other package requirements includes Secs. 71.41-71.47, plus a

specific reference to. An argument could also be made for deleting the

entire reference because those requirements apply regardless of the

reference in this section. However, NRC chose to include the reference

in Sec. 71.52 as a reminder that the exemption is only from Sec. 71.51,

not from all packaging requirements. NRC believes the reference to

Sec. 71.43(f) (normal conditions of transport tests) is important and

has decided that it will be retained.

One comment suggested that SCO be included within the scope of

Sec. 71.52, and that the 2A1 limit be included in the section for

clarity. NRC agrees with the comment and has made the clarifications,

substituting the IAEA LSA limit for 2A1.

Section 71.53 Fissile Material Exemptions

One comment suggested spelling out the word ``liter'' instead of

using ``l'' as the abbreviation. Considering the typing errors caused

by the use of that abbreviation, the final rule spells out the word

``liter'' wherever it appears.

Section 71.55 General Requirements for Fissile Material Packages

One comment suggested that by adding the word ``full'' to the water

reflection criterion of Sec. 71.55(b)(3), the NRC has added more cost

with no apparent benefit ``* * * since transport limits already take

this consideration into account.'' The latter part of this comment

probably refers to the ``transport index'' controls that limit the

number of packages which can be transported and stored together, but do

not consider the safety of an individual package in isolation. Addition

of the word ``full'' in Sec. 71.55(b)(3) is a matter of clarification.

NRC has always required ``full'' reflection wherever reflection is

required. IAEA regulations required ``full'' reflection in the 1973

edition, and go a step further in the 1985 edition, to define ``full''

as ``water 20-cm thick (or its equivalent).'' NRC has retained the word

``full,'' in Sec. 71.55(b)(3), and has added the word ``full,'' in

Sec. 71.55(e)(3), for consistency.

A commenter agrees that the proposed Part 71 begins to simplify the

system of shipping fissile material but that most of the difficulties

still exist. The commenter advocates development of ``a system of

performance-oriented packaging,'' to reduce the current complexity of

the ``design-oriented package choices.'' NRC agrees that there are a

number of radiation control design requirements that apply to the

fissile material packages as well as to packages of other radioactive

material. However, NRC views the criticality control provisions as

performance-oriented rather than design-oriented. NRC must specify the

conditions against which the package must be designed. Without the

environmental tests and package objectives, there would be no level of

protection against which to design packages.

Section 71.61 Special Requirement for Irradiated Nuclear Fuel

Shipments

One comment recommended that the rule clarify that the deep

immersion test is to be applied to an otherwise undamaged package. This

important detail is implied, but not specifically stated. The

Commission agrees and has made that clarification.

In the final rule, this section has been modified to require that

the external pressure test be applied directly to the containment

system of a package. NRC does not believe the external structure should

play a part in helping the containment system of a package withstand an

external pressure test and has chosen to ignore its existence in

specifying the requirement.

A comment recommended that the word ``rupture,'' as used in this

requirement, be defined as a gross structural collapse and not just an

inleakage of water. Although the word ``rupture'' in the proposed rule

did mean gross structural collapse, NRC has since decided that the term

``rupture'' cannot be determined by engineering analysis. NRC has

decided to change the acceptance criteria for the deep immersion test

from ``rupture'' to ``collapse, buckling, or inleakage of water.''

A comment stated that this requirement should include the 1-hour

time specification included in the IAEA requirement to avoid later

misinterpretation of the test. The NRC agrees that adding the 1-hour

test specification would help prevent confusion between IAEA and

domestic regulations, and has included the time specification.

[[Page 50257]]

A comment noted that the term ``at least'' is used two times in the

proposed requirement, thereby creating an opportunity for

misinterpretation. Although the term is used in the IAEA text, the NRC

agrees with the commenter that it serves no useful purpose and has

deleted the term.

A comment stated that the deep-water immersion test should be

clarified to ensure that an engineering evaluation is an acceptable

alternative to a physical test because an actual 200-m test would be

costly and difficult. NRC believes it is clear that an engineering

evaluation is acceptable because the equivalent external gauge pressure

is specified in the text of the requirement. The provisions of

Sec. 71.41(a) are intended to allow the use of engineering evaluations

when they are reasonably applied.

The remaining three comments relating to this section all deal with

transition periods and special provisions for casks for which there

will be no further fabrication and that are not used internationally.

The earlier portion of this preamble dealing with the provisions of

Sec. 71.13 presents the NRC view on these matters.

Section 71.63 Special Requirements for Plutonium Shipments

Four comments argued that the extension of this provision to

radionuclides other than plutonium is unjustified and that the

provision, even without the extension to other radionuclides, differs

from IAEA rules and is inconsistent with the principles of IAEA rules.

Two of the commenters argued further that the existing provisions, if

examined in the light of current regulatory analyses, probably could

not be justified.

NRC recognizes that some requirements have been added to the

regulations over the years strictly on the basis of prudent judgment.

Because the basis for current rules is not a part of this rulemaking

action, NRC will simply refrain from extending the present rule to

other radionuclides.

One commenter argued that the rule should be rewritten using

multiples of the A2 values, not only to define radionuclides

subject to the rule, but also to define the level of activity at which

the extra requirements come into effect. Because the extension to other

radionuclides is being withdrawn, the inclusion of A values does not

appear to improve the requirement.

Section 71.71 Normal Conditions of Transport

Three comments noted that the provision of IAEA's paragraph 528

requiring consideration of a temperature range from -40 deg.C to +70

deg.C for the components of the packaging is not reflected in Part 71.

NRC omitted this provision because NRC does not want to limit the high

end temperature consideration to 70 deg.C because that would imply

that +70 deg.C is the highest temperature that has to be considered

for package design. This does not take into account the considerably

higher temperatures resulting from decay heat in certain Type B

packages.

Three comments noted that 10 CFR 71.71(c)(4) prescribes an

increased external pressure specification of 140 kPa absolute but IAEA

regulations do not have that exact requirement. NRC believes there is a

need for an external pressure test for normal conditions to ensure that

a package filled at low pressure or high altitude will withstand an

external pressure increase. The additional pressure test has been

retained.

Three comments observed that Sec. 71.71(c)(7) states that the free

drop test be conducted between 1.5 and 2.5 hours after the conclusion

of the water spray test but the same requirement is not included in the

IAEA regulations. The IAEA rules, however, do include restrictions, in

paragraph 620, on the timing of the mechanical tests after the water

spray test. NRC has retained the water spray test as is and believes

the NRC test meets the intent of the IAEA test.

One comment noted that with the deletion of the fissile classes,

the corner drop test, which was required only for Fissile Class II

packages, is proposed to be applied to all fissile packages. The

commenter argued that for a large and heavy package, such as a spent

fuel shipping cask, ``it is considered highly implausible for a package

to undergo a one-foot corner drop as a normal condition of transport.

Only a free drop with the package in its normal orientation should be

specified as a normal condition of transport for large and heavy

packages, therefore saving valuable analysis effort and time.''

NRC agrees with the comment and has deleted the corner drop test

for fiberboard, wood, or fissile material rectangular packages weighing

more than 50 kg (110 lb), and for fissile material cylindrical packages

weighing more than 100 kg (220 lb). For these packages, NRC does not

believe that the corner drop tests are significant in developing a safe

fissile material package.

Section 71.73 Hypothetical Accident Conditions

One comment stated that reversing the order of the two immersion

tests in Secs. 71.73 (c)(5) and (c)(6) would restore the order of the

tests, which must be run consecutively, and would therefore clarify the

text. NRC agrees and has made the change.

One comment recommended that the temperature extremes specified for

the initial test conditions in Sec. 71.73(b) be given a reasonable

tolerance because ambient air temperatures cannot be controlled. NRC

agrees that temperatures, as with other required parameters of the test

conditions, cannot be accurately controlled. NRC's position, however,

is not to establish tolerances, but to require that the effects of test

conditions different from those specified be analyzed as part of the

overall evaluation. Every analysis would then be normalized to the same

set of specifications.

One comment recommended that the word ``single,'' in the second

line of the thermal test in Sec. 71.73(c)(4), should be ``simple''. NRC

agrees and has made that change.

Two comments asked that NRC include some information as to how the

effects of solar radiation should be treated. One comment stated, ``The

solar insolation can be a significant factor and should be consistently

evaluated.'' Others have argued that the effects of solar insolation

are insignificant compared with the thermal effects of the fire test

and should be ignored.

NRC adopts the view of the thermal experts who participated in

developing the IAEA regulations. Those experts thought the effects of

solar radiation may be neglected before and during the thermal test but

that such effects should be considered in the subsequent evaluation of

the package response.

One comment recommended the development of guidance on how

designers should interpret the revised thermal test requirement.

Although there is guidance provided in the IAEA's companion documents

to its transportation regulations (IAEA Safety Series No. 7,

``Explanatory Material for the IAEA Regulations for the Safe Transport

of Radioactive Material--1985 Edition,'' and IAEA Safety Series No. 37,

``Advisory Material for the IAEA Regulations for the Safe Transport of

Radioactive Material--1985 Edition''), further guidance may be

necessary. If so, it is the industry that can best propose guidance,

based on its capabilities. If coordinated under the auspices of the

American National Standards Institute (ANSI), Committee N-14, with NRC

representation, there is a good chance that a consensus standard could

be developed that could be endorsed by NRC as a satisfactory means to

satisfy regulatory requirements.

[[Page 50258]]

One comment stated that packages that are subjected to the crush

test should not also be subjected to the 30-foot free drop test, as

required in the proposed rule. Instead, consistent with IAEA, the crush

test should be in lieu of the 30-foot free drop test.

NRC believes that the crush test and the free drop test impart

different types of loadings onto the package. Having sufficient crush

resistance for the crush test does not ensure the adequacy of the

package under the inertial loadings that occur during the 30-foot drop

tests. NRC believes that it is important for packages to have

resistance to impact and that the crush test should not be a substitute

for the impact test.

One comment stated that a crush scenario is not likely during

``dedicated'' shipments because heavy loads are not placed above the

shipment at any time during transport. The comment questioned the

applicability of the test for dedicated shipments, and requested that

at least an engineering evaluation be allowed as an alternative to a

physical test. NRC has made it clear (see Sec. 71.41) that appropriate

analyses may be used to demonstrate the ability of a package to meet

crush test conditions.

Section 71.75 Qualifications of Special Form Radioactive Material

One comment indicates that changes in Sec. 71.75(a) from the

current rule have changed the concept of special form from being a

provision for special properties of the radioactive material contents

of the package to being a provision for special properties of the

package--a change from qualifying a ``special form source'' to

qualifying a ``special form package.''

NRC regrets the confusion, but intended no substantive change to

the concept of special form. Special form criteria in this final rule

have been brought closer to those of DOT, but still without any basic

changes.

One comment noted that the reference in Sec. 71.75(e)

[Sec. 71.75(d), in the final rule], to a standard of the International

Standard Organization (ISO) is vague and should be made more specific.

Although the ISO standard could be written in all its detail in

Part 71, rather than simply referenced there, most comments over the

years have encouraged NRC to have less repetition and more simple

references to other requirements.

Section 71.83 Assumptions as to Unknown Properties

One comment pointed out an error in line 7 of Sec. 71.83, where the

proposed rule referred to ``known properties'', where it should have

referred to ``unknown properties.'' That error has been corrected.

Section 71.85 Preliminary Determinations

One comment recommended that the term ``durable'' in the context of

``durably mark the packaging,'' as in Sec. 71.85, be defined in terms

of the conditions that the markings on the packaging must be able to

withstand. When developing its regulations, NRC must decide at what

level of detail they are to be written. Sometimes that level of detail

is changed as a result of experience if a widespread misuse of a

standard becomes known because of a lack of detail. NRC is not aware of

any problem with the term ``durably,'' even though it has been used

since 1968 in the preliminary determinations section. In the absence of

a significant problem, NRC prefers to leave the term as is.

Section 71.87 Routine Determinations

One comment recommended that NRC's Table V ``Removable External

Radioactive Contamination Wipe Limits,'' be used by DOT in place of its

Table 11. NRC notes that the only significant difference between the

two tables is that the term ``low toxicity alpha emitters'' is replaced

by its definition in the NRC table. The NRC final rule simply refers to

the DOT requirement (49 CFR 173.443) for maximum permissible

contamination limits.

Section 71.88 Air Transport of Plutonium

One comment recommended that the forward tie-down specification of

9 g detailed in Sec. 71.88(c)(2) be reduced to 1.5 g for plutonium

packages transported on a Boeing 747 aircraft. The reason for this

recommendation has to do with the 14 CFR 25.561 regulatory requirement

of the Federal Aviation Administration (FAA), that the supporting

structure of an airplane must be designed to restrain, up to specified

inertial forces, including 9-g in the forward direction, ``* * * each

item of mass that could injure an occupant if it came loose in a minor

crash landing.'' NRC, in prescribing tie-down requirements for

plutonium packages in aircraft, took note of the supporting structure

requirements of the FAA and required a 9-g tie-down system for the

package on the main deck of the aircraft. The Boeing 747 cargo

aircraft, however, with no passengers and the cockpit located above the

main deck, is not subject to the requirements of 14 CFR 25.561 because

there are no occupants to injure if ``* * * the package came loose in a

minor crash landing.'' Thus, the Boeing 747 ``Weight and Balance

Manual,'' DG-13700, shows a load factor of 1.5 g in the forward

direction.

The purpose of the NRC tie-down requirement was not to protect

occupants of the aircraft from cargo that has come loose in a minor

crash landing. Therefore, the comparison with the FAA supporting

structure requirement is not germane. The purpose of the NRC

requirement was to protect the plutonium package from the uncontrolled

potential for damage inherent in having the package unrestrained in a

crash landing.

Paragraph (c) of Sec. 71.88 proposed a requirement that the

licensee make special arrangements with the carrier on where to place

the plutonium cargo in the aircraft, how to tie it down, and what

restrictions are to be placed on other cargo. Recognizing that these

restrictions would be more appropriately placed directly on the carrier

rather than through the shipper, the DOT has placed these restrictions

in its air carrier regulations (Sec. 175.704 of 49 CFR Part 175,

``Carriage By Aircraft.'') These regulations are now referenced in

Sec. 71.88.

Section 71.95 Reports

All three public comments on this section were directed at the

newly proposed provisions of paragraph (c), which require a 30-day

report of ``* * * instances in which the conditions of approval in the

certificate of compliance were not observed in making a shipment.''

One comment requested clarification whether Sec. 71.95(c) applies

to shippers or receivers.

The scope of Part 71 (Sec. 71.0(c)) makes the regulation applicable

only to shippers of radioactive material. Therefore, Sec. 71.95(c)

applies only to shippers of radioactive material. However, shipment

deficiency may be detected by the receiver of the shipment. If the

receiver reports that deficiency to the shipper, the shipper is

obligated to report it to NRC. Further, note that 10 CFR Part 21,

``Reporting of Defects and Noncompliance'', is applicable to receiving

facilities.

The other two comments dealt with the substance of the event that

would prompt the report. One suggested the regulation be more specific

on conditions that would require a report. The second comment suggested

that the report include the consequences of the deficient shipment such

as radioactive contamination, a loosened sealing cap, etc.

Although both of these suggestions have merit, neither has been

[[Page 50259]]

incorporated in the final rule. The purpose of the requirement is to

provide feedback to NRC on quality assurance program effectiveness by

an indication of the number and type of packaging and other mistakes

and on the safety significance of those mistakes by an indication of

the mistake consequences. NRC believes the reporting requirement should

retain its broad scope. A large number of reports is not expected. NRC

also believes that individual follow-up is the only reasonable way to

uncover any procedural deficiency that might cause mistakes.

One comment questioned whether this type of report is important

enough to be required within 30 days. NRC judges that the timing is

about right, and expects the staff's review of submitted reports to be

completed within a similar time frame.

Section 71.97 Advance Notification of Shipment of Irradiated Reactor

Fuel and Nuclear Waste

Of the five comments submitted on this notification requirement,

two suggested changing the value for the number of curies in

Sec. 71.97(b)(3)(iii), so it corresponds to the same limit in the

regulations of DOT and IAEA. That change has been made.

The other three comments stated that this requirement was not

clearly expressed. The requirement has been reorganized in the final

rule, and consists of the following parts:

1. Paragraph (a) provides a broad general requirement that

licensees pre-notify governors of States of any shipments of

radioactive material going to, through, or across the boundary of the

State;

2. Paragraph (b) limits the prenotification requirement to certain

types of shipments. All the conditions of paragraph (b) must be

satisfied for the prenotification requirement to apply. The licensed

material must be required to be in a Type B package, limiting the

requirement to shipments of relatively high potential hazard. The

shipment must be destined to a disposal site or to a collection point

for transport to a disposal site, further limiting the requirement to

waste material. The quantity of radioactive waste in a single package

must exceed the limits specified in the DOT regulations for highway-

route controlled quantities. Lastly, for irradiated fuel, the quantity

contained in a single package must be less than that subject to the

similar advance notification requirement of 10 CFR 73.37(f).

3. Paragraphs (c), (d), (e) and (f) contain the details for timing,

information in the notification, revisions, and cancellation.

One comment noted that from the wording in Sec. 71.97(a), a reader

would expect to find exceptions in Sec. 71.97(b). The comment notes

that the provision does not contain exceptions. NRC agrees with this

comment and has revised Sec. 71.97(a) for clarity.

One comment questioned the value of proposed Sec. 71.97(b)(4)

[Sec. 71.97(b) in the final rule] which required that ``* * * the

quantity of irradiated fuel is less than that subject to advance

notification requirements of Sec. 73.37(f) of this chapter.'' Paragraph

73.37(f) refers to a separate part of the Commission's regulations, 10

CFR Part 73, ``Physical Protection of Plants and Materials,'' and

imposes an advance notification requirement for irradiated fuel

shipments similar to the one under discussion. The scope of Part 73

(see Sec. 73.1(b)(5)) limits its applicability regarding shipments of

irradiated reactor fuel to ``* * * quantities that in a single shipment

both exceed 100 grams in net weight of irradiated fuel, exclusive of

cladding or other structural or packaging material, and have a total

radiation dose rate in excess of 100 rems per hour at a distance of 3

feet from any accessible surface without intervening shielding.'' If

the quantity of irradiated fuel in a shipment exceeded the quantity

specified in Sec. 73.1(b)(5), the notification would be made under

Sec. 73.37(f). If not, the notification would be made under Sec. 71.97.

The proposed provision in Sec. 71.97(b)(4) was intended to prevent

duplicate notifications for some shipments.

The final comment on Sec. 71.97 included a clear rewrite of

Sec. 71.97(b) that has been used in its entirety in the final rule.

Comments on Appendix A

Five comments supported the inclusion of new radionuclides in Table

A-1 of Appendix A as useful and justified. Five other comments pointed

out errors and inconsistencies between NRC and DOT for the A1/

A2 values in Table A-1. These inconsistencies have been corrected

in the NRC and DOT final rules.

Three comments recommended a grandfathering provision for the

continued authority to transport molybdenum (Mo) 99/technetium (Tc) 99m

generators, in Type A packages, with radioactivity between the current

A2 value of 20 Ci and the new A2 value of 13.5 Ci for Mo-99.

The lower A2 value is the result of a new dosimetric model, for

beta-emitting radionuclides, to address skin contamination. In the

preamble to the NRC proposed rule, the NRC noted, with respect to the

changes in the A1 and A2 values:

Based on our most current knowledge of radioactive material

shipments in the United States, the economic impacts of these

changes are not likely to be large. However, any situations where a

potential exists for significant economic impacts as a result of

changes in the A1 or A2 values should be brought to the

NRC's attention in public comments.

NRC agrees that this is a situation where health care in the United

States could be significantly impacted as a result of forcing the

larger quantity Mo-99/Tc-99m generators now transported in Type A

packages into Type B packages. In view of the favorable experience over

the years with these generators, NRC and DOT will allow the continued

domestic transportation of generators that contain up to 20 Ci of

radioactive material in Type A packages.

Two similar proposals to grandfather the transportation of carbon-

14, phosphorus-32, sulfur-35, and iodine-125 at existing levels were

not as persuasive and have not been adopted. The decrease in A1

and A2 values would apparently force many shipments out of the

``limited quantity'' category, where they are excepted from

specification packaging, shipping papers and certification, and marking

and labeling requirements, and into the ``Type A'' category.

Although there are clearly more packaging and communication

requirements associated with the ``Type A'' category than with the

``limited quantity'' category, NRC does not view that change as

creating the same economic impact as a change from the ``Type A'' to

the ``Type B'' category.

One comment suggested that the radionuclides einsteinium-253 and

einsteinium-254 be added to Table A-1 because shipment of those

transuranics are increasing in number and the default values are not

expected to be adequate. NRC has added those radionuclides and will

also propose them for addition to the IAEA regulations. Until they are

included in IAEA Safety Series No. 6, however, multilateral approval is

required for international shipments. This limitation is identified by

footnote in Table A-1.

One comment objected to having to obtain NRC approval of A1/

A2 values that are not in Table A-1. In addition to NRC approval,

international shipments require multilateral approval of A values that

are not included in the IAEA regulations by each country through or

into which the consignment is to be transported. The development of A

values may not be a simple matter, requiring consideration of daughter

[[Page 50260]]

radionuclides and differing radioactive emissions. Although a competent

health physicist or nuclear engineer should not have too much

difficulty determining an A value, NRC must assure that a system exists

to protect against faulty determinations. Use of the conservative A

values from Table A-2 does not require regulatory approval.

One commenter questioned the unlimited values, for A1 and

A2 in Table A-1, for uranium-235 enriched less than 5 percent. The

comment argued that U-235 is a fissile material and the unlimited

values may not be appropriate. The A1/A2 values are for

radiological, not fissile, considerations. The A1/A2 values

set the maximum quantity of radioactive material that can be shipped in

a Type A package (except for LSA); other package characteristics, such

as heat generation, weight, criticality, external radiation, etc., can

further limit the quantity of radioactive material in that Type A

package. Limitations with respect to fissile characteristics, for

example, are addressed in Secs. 71.53, 71.55, and 71.59. NRC has

decided to add a clarifying note, currently in the IAEA regulations, to

the A1/A2 Table in Appendix A of Part 71. The Appendix A note

reads ``Where values of A1 and A2 are unlimited, it is for

radiation control purposes only. For nuclear criticality safety, some

materials are subject to controls placed on fissile material.''

Finally, one comment suggested that we eliminate the specific

activity column from Table A-1. The comment argues that ``Specific

activity information is not required or explained in the regulations,

and it is difficult to keep the information accurate.''

Although the NRC is in basic agreement with the comment and would

have no problem in eliminating the specific activity data from Part 71

if there were a good source of comparable data available for the times

it is needed to implement the transportation regulations. NRC is not

familiar with any good substitute source. Though IAEA Safety Series No.

37, ``Advisory Material for the IAEA Regulations for the Safe Transport

of Radioactive Material (1985 Edition),'' third edition, published in

June 1987, includes a table of half-lives and specific-activities,

there is no indication yet of a system of periodic reviews that would

keep that information up to date.

Comments on Draft Regulatory Analysis

Ten persons commented on the impacts associated with the proposed

changes to limit the content of LSA/SCO packages to 2A1. The main

thrust of these comments is that the impacts are much greater than

presented. In part in response to these comments, NRC has adopted in

the final rule the IAEA LSA/SCO package limit of 10 mSv/h (1 rem/h) at

3 m, in lieu of the proposed 2A1 limit.

Because the NRC data base for determining the additional shipments

expected to be caused by the proposed rule dated back to 1980, and

because a clear preference was developing in the public comments for

the IAEA radiation level limit rather than the 2A1 limit, NRC

repeated its analysis using more recent data. An NRC contractor

gathered 1989 data from the 3 shallow land burial facilities for all

waste shipments of resins, evaporator bottoms, and filter media. The

contractor analyzed the characteristics of those 4600 Type A cask

shipments and found that approximately 150 of those shipments would

have exceeded the IAEA limit. NRC assumes that each shipment exceeding

the limit is split into 2 shipments due to the smaller capacity of Type

B packaging. Thus 150 additional shipments are caused by the LSA limit.

The impacts of preparing additional packages of LSA waste for

shipment and receiving those additional shipments at the burial ground

were absent from the draft regulatory analysis. One comment advised the

NRC of the results of an exposure study which concluded that the extent

of the collective exposure for preparation and receipt of waste casks

was approximately 0.5 person-rem per shipment. The NRC noted that half

of the 0.5 person-rem per shipment factor multiplied by the 4600 waste

cask shipments per year from the new data base corresponds fairly well

to a large portion of the 1726 person-rem collective exposure reported

for all light water reactors for 1986 under the category ``waste

processing'' by Barbara G. Brooks, NRC, and D. Hagemeyer, SAIC in

NUREG-0713, Vol. 8, dated August 1989 (this version was current at the

time the contractor prepared the regulatory analysis). On the basis of

this data, NRC has accepted the 0.5 man-rem per shipment number as a

reasonable estimate. Multiplying that 0.5 man-rem per shipment

conversion factor by the 150 additional shipments which the limit of 1

rem per hour at 3 meters would cause, the effect of the limit would be

75 person-rem per year.

Because the IAEA LSA provisions permit a greater quantity of LSA/

SCO material to be shipped in a package, fewer packages and shipments

are needed to transport a given quantity of material. The estimated

burden on industry from the final rule is therefore less than that for

the proposed rule. The NRC draft regulatory analysis dated November,

1987 developed industry costs resulting from a 2A1 limit on LSA

shipments of $1.7 million per year. These costs consist of package

costs and shipment costs resulting from an estimated 311 additional

cask shipments per year. Through the same simple modeling used in the

older analysis, the new NRC regulatory analysis shows increased dollar

costs associated with the 150 additional LSA/SCO shipments of $1.0

million per year. These estimates include differential package costs

and differential shipping and handling costs, annualizing and summing

each component. These estimates do not include cost components

recognized but not quantified in the public comments as training,

procedure revisions, computer program changes and upgrades, insurance

premiums, and disposal costs.

There were no significant comments related to the projected number

of non-radiological deaths and injuries associated with the increased

shipments caused by the new standards.

Agreement State Compatibility

Section 274d.(2) of the Atomic Energy Act of 1954, as amended,

requires that before entering into an agreement with any State, the

Commission shall make a determination that the State's program is

compatible with the Commission's program. Section 274g authorizes and

directs the Commission to cooperate with the States in the formulation

of standards to assure that State and Commission programs will be

coordinated and compatible. The basic objective of NRC's State

Agreements Program has been to achieve uniformity among the various

programs to the maximum extent practicable recognizing that the States

must be allowed some flexibility to accommodate local conditions. Under

this Program, procedures have established criteria for better defining

compatibility, and for determining the degree to which States

regulations must show uniformity with Commission regulations. In

practice, the Commission's regulations are categorized as Division 1-4

Rules according to the degree of State regulation uniformity required,

as summarized in the following table:

------------------------------------------------------------------------

Division Agreement State regulation uniformity

------------------------------------------------------------------------

1............ Agreement States are expected to adopt, essentially

verbatim, the regulation to provide consistency between

Federal and State requirements.

[[Page 50261]]

2............ Agreement States have the flexibility to adopt similar or

more stringent requirements based on their radiation

protection experience, professional judgements, and

community values.

3............ Agreement States should adopt the requirement, but there

is no degree of uniformity between NRC and Agreement

States required.

4............ Agreement States should not adopt the requirement since

these are regulatory functions reserved to NRC.

------------------------------------------------------------------------

The final rule does not affect the current compatibility

categorization of Part 71 regulations. The following table lists the

Part 71 Sections and corresponding rule categorization (Division 1-4):

----------------------------------------------------------------------------------------------------------------

Division Section Title

----------------------------------------------------------------------------------------------------------------

1......................... 71.4...................... Definitions.

1......................... 71.5...................... Transportation of Licensed Material.

1......................... 71.10..................... Exemption for Low-Level Materials.

1......................... Appendix A................ Determination of A1 and A2.

2......................... 71.12..................... General License: NRC-Approved Package.

2......................... 71.13..................... Previously Approved Package.

2......................... 71.14..................... General License: DOT Specification Container.

2......................... 71.16..................... General License: Use of Foreign Approved Package.

2......................... 71.81..................... Applicability of Operating Controls and Procedures.

2......................... 71.85..................... Preliminary Determinations.

2......................... 71.87..................... Routine Determinations.

2......................... 71.88..................... Air Transport of Plutonium.

2......................... 71.89..................... Opening Instructions.

2......................... 71.97..................... Advance Notification of Shipment of Irradiated Reactor

Fuel and Nuclear Waste.

3......................... 71.0...................... Purpose and Scope.

3......................... 71.1...................... Communications.

3......................... 71.2...................... Interpretations.

3......................... 71.3...................... Requirement for License.

3......................... 71.7...................... Completeness and Accuracy of Information.

3......................... 71.8...................... Specific Exemptions.

3......................... 71.9...................... Exemption of Physicians.

3......................... 71.91..................... Records.

3......................... 71.93..................... Inspections and Tests.

3......................... 71.95..................... Reports.

3......................... 71.99..................... Violations.

3......................... 71.101.................... Quality Assurance Requirements.

3......................... 71.103.................... Quality Assurance Organization.

3......................... 71.105.................... Quality Assurance Program.

3......................... 71.107.................... Package Design Control.

3......................... 71.109.................... Procurement Document Control.

3......................... 71.111.................... Instructions, Procedures, and Drawings.

3......................... 71.113.................... Document Control.

3......................... 71.115.................... Control of Purchased Material, Equipment, and Services.

3......................... 71.117.................... Identification and Control of Materials, Parts, and

Components.

3......................... 71.119.................... Control of Special Process.

3......................... 71.121.................... Internal Inspection.

3......................... 71.123.................... Test Control.

3......................... 71.125.................... Control of Measuring and Test Equipment.

3......................... 71.127.................... Handling, Storage, and Shipping Control.

3......................... 71.129.................... Inspection, Test and Operating Status.

3......................... 71.131.................... Nonconforming Materials, Parts, or Components.

3......................... 71.133.................... Corrective Action.

3......................... 71.135.................... Quality Assurance Records.

3......................... 71.137.................... Audits.

4......................... 71.6...................... Information Collection Requirements: OMB Approval.

4......................... 71.18..................... General License: Fissile Material, Limited Quantity per

Package.

4......................... 71.20..................... General license: Fissile Material, Limited Moderator per

Package.

4......................... 71.22..................... General License: Fissile Material, Limited Quantity,

Controlled Shipment.

4......................... 71.24..................... General License: Fissile Material, Limited Moderator,

Controlled Shipment.

4......................... 71.31..................... Contents of Application.

4......................... 71.33..................... Package Description.

4......................... 71.35..................... Package Evaluation.

4......................... 71.37..................... Quality Assurance.

4......................... 71.38..................... Renewal of a Certificate of Compliance or Quality

Assurance Program Approval.

4......................... 71.39..................... Requirement for Additional Information.

4......................... 71.41..................... Demonstration of Compliance.

4......................... 71.43..................... General Standards for all Packages.

4......................... 71.45..................... Lifting and Tie-down Standards for all Packages.

4......................... 71.47..................... External Radiation Standards for all Packages.

4......................... 71.51..................... Additional Requirements for Type B Packages.

[[Page 50262]]

4......................... 71.52..................... Exemption for Low-Specific-Activity (LSA) Packages.

4......................... 71.53..................... Fissile Material Exemptions.

4......................... 71.55..................... General Requirements for Fissile Material Packages.

4......................... 71.59..................... Standards for Arrays of fissile Material Packages.

4......................... 71.61..................... Special Requirement for Irradiated Nuclear Fuel

Shipments.

4......................... 71.63..................... Special Requirements for Plutonium Shipments.

4......................... 71.64..................... Special Requirements for Plutonium Air Shipments.

4......................... 71.65..................... Additional Requirements.

4......................... 71.71..................... Normal Conditions of Transport.

4......................... 71.73..................... Hypothetical Accident Conditions.

4......................... 71.74..................... Accident Conditions for Air Transport of Plutonium.

4......................... 71.75..................... Qualification of Special Form Radioactive Material.

4......................... 71.77..................... Qualification of LSA-III Material.

4......................... 71.83..................... Assumptions as to Unknown Properties.

4......................... 71.100.................... Criminal Penalties.

----------------------------------------------------------------------------------------------------------------

Petitions for Rulemaking

Three petitions for rulemaking were filed with the NRC in

connection with the rules for transporting LSA radioactive material.

The substance of each of the three petitions was essentially the same,

to request that NRC exempt LSA materials from its requirements in Part

71.

The petitioners were the Energy Research and Development

Administration (now the U.S. Department of Energy) in its letter dated

July 23, 1975 (PRM-71-1); ANSI Committee N14, in its letter dated March

10, 1976 (PRM-71-2); and Chem-Nuclear Systems, Inc., in its letter

dated November 22, 1976 (PRM-71-4). At the time these petitions were

filed, DOT regulated carriers and shippers of small quantities of all

radioactive materials (including LSA materials) through provisions in

its regulations in 49 CFR Parts 170-189, whereas NRC regulated shippers

of fissile material and of larger quantities of other radioactive

materials (including LSA materials) through its regulations in Part 71

and its licensing program. All three petitioners argued that the

control NRC was exerting over transportation of LSA materials created

an inconsistency between NRC regulations and those of the IAEA and

should be discontinued. A proposed rule that would have provided the

exemption for LSA materials requested in the petitions was published by

NRC for public comment on August 17, 1979 (44 FR 48234). Before

finalization of that rule, however, a deficiency in the new LSA

requirements, as proposed, was recognized so that the entire LSA

proposal, including the exemption, was withdrawn. In the interim, the

corresponding deficiency in the LSA requirements in the IAEA

regulations was recognized and corrected. That correction is discussed

under the ``major modifications from proposed rule'' section of this

preamble. This correction is implemented in both DOT regulations and

NRC regulations.

The exemption requested in the three petitions has been superseded

by the changes in LSA requirements. The LSA requirements imposed in NRC

regulations are an integral part of the NRC/DOT regulatory scheme for

LSA materials. This scheme is based on IAEA regulations. There is an

exemption provided for LSA materials in Sec. 71.10 that clearly defines

the level where NRC regulations impose additional packaging

requirements. For the above reasons, NRC has denied the petitions.

Administrative Correction

At about the same time the Notice of Proposed Rulemaking regarding

compatibility with IAEA transportation regulations was published for

public comment on June 8, 1988 (53 FR 21550), a separate notice of

final rulemaking was issued, by NRC, affecting the retention periods

for records (53 FR 19240, May 27, 1988). Included in that separate

notice were changes to the transportation regulations in Part 71,

specifically to Secs. 71.105, ``Quality assurance program,'' and

71.135, ``Quality assurance records.'' Because the two rules were being

processed at the same time by different organizations, NRC's internal

controls failed to recognize that the new quality assurance provisions

needed to be incorporated in the June 8, 1988, notice of proposed

rulemaking. No written comments were filed with respect to the quality

assurance sections proposed, although two phone calls were received

advising NRC of its error. The quality assurance changes that were made

effective by the final rule, published on May 27, 1988, are included in

this final rule.

Finding of No Significant Environmental Impact: Availability

The Commission has determined, under the National Environmental

Policy Act of 1969, as amended, and the Commission's regulations in

Subpart A of 10 CFR Part 51, that this rule is not a major Federal

action significantly affecting the quality of the human environment,

and therefore an environmental impact statement (EIS) is not required.

The Commission's ``Final Environmental Statement on the

Transportation of Radioactive Material by Air and Other Modes,'' NUREG-

0170,3 dated December 1977, is NRC's generic EIS, covering all

types of radioactive material transportation by all modes (road, rail,

air, and water). From the Commission's latest survey of radioactive

material shipments and their characteristics, ``Transport of

Radioactive Material in the United States,'' SAND 84-7174, April 1985,

it can be concluded that current radioactive material shipments are not

so different from those evaluated in NUREG-0170 as to invalidate the

results or conclusions of that EIS. Environmental impacts associated

with this rulemaking are evaluated in ``Regulatory Analysis of Changes

to 10 CFR Part 71--NRC Regulations on Packaging and Transportation of

Radioactive Material,'' dated April 1995.

\3\ Copies of NUREG-0170 may be purchased from the

Superintendent of Documents, U.S. Government Printing Office, P.O.

Box 37082, Washington, DC 20013-7082. Copies are also available from

the National Technical Information Service, 5285 Port Royal Road,

Springfield, VA 22161. A copy is also available for inspection and

copying for a fee in the NRC Public Document Room, 2120 L Street,

NW. (Lower Level), Washington, DC.

---------------------------------------------------------------------------

NUREG-0170 established the non-accident related radiation exposures

associated with transportation of radioactive material in the United

States as 98 person-Sv (9800 person-rem) which, based on the

conservative linear

[[Page 50263]]

radiation dose hypothesis, resulted in a maximum of 1.7 genetic effects

and 1.2 latent cancer effects per year. More than half this impact

resulted from shipment of medical-use radioactive materials. Accident

related impacts were established at a maximum of one genetic effect and

one latent cancer fatality for 200 years of transporting radioactive

materials. The principal nonradiological impacts were found to be two

injuries per year, and less than one accidental death per 4 years. In

contrast, non-accident related radiation exposures associated with this

rulemaking would be increased by 0.75 person-Sv/y (75.0 person-rem/y),

whereas accident related impacts would be decreased by approximately

0.006 person-Sv/y (0.6 person-rem/y). Nonradiological traffic injuries

would be increased by 0.06 per year and nonradiological traffic deaths

by 0.003 per year (less than 1 accidental death per 330 years). These

impacts are judged to be insignificant compared with the baseline

impacts established in NUREG-0170.

The environmental assessment and finding of no significant impact

on which this determination is based are available, for inspection, at

the NRC Public Document Room, 2120 L Street NW. (Lower Level),

Washington, DC. Single copies of the environmental assessment and

finding of no significant impact are also available from the contact

listed under the Addresses heading.

Paperwork Reduction Act Statement

This final rule amends information collection requirements that are

subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et

seq.). These requirements were approved by the Office of Management and

Budget, Approval Number 3150-0008.

The public reporting burden for this collection of information is

estimated to average 7 hours per response, including the time for

reviewing instructions, searching existing data sources, gathering and

maintaining the data needed, and completing and reviewing the

collection of information. Send comments regarding this burden estimate

or any other aspect of this collection of information, including

suggestions for reducing this burden, to the Information and Records

Management Branch (T-6F33), U.S. Nuclear Regulatory Commission,

Washington, DC 20555-0001; and to the Desk Officer, Office of

Information and Regulatory Affairs, NEOB-10202, (3150-0008), Office of

Management and Budget, Washington, D.C. 20503.

Regulatory Analysis

The NRC has prepared a regulatory analysis on this final

regulation. The analysis examines the costs and benefits of the

alternatives considered by NRC. Interested persons may examine a copy

of the regulatory analysis at the NRC Public Document Room at 2120 L

Street NW. (Lower Level), Washington, DC. Single copies of the analysis

may be obtained from the contact listed under the Addresses heading.

Regulatory Flexibility Act Certification

In accordance with the Regulatory Flexibility Act of 1980 (5 U.S.C.

605(b)), the Commission certifies that this rule does not have a

significant economic impact on a substantial number of small entities.

This final rule affects NRC licensees, including operators of nuclear

power plants, who transport or deliver to a carrier, for transport,

relatively large quantities of radioactive material, in a single

package. These companies do not generally fall within the scope of the

definition of ``small entities'' set forth in the Regulatory

Flexibility Act or the size standards adopted by the NRC (10 CFR

2.810).

Backfit Analysis

The Commission has determined that the backfit rule does not apply

to the Part 71 final rule because the final rule is not a backfit under

10 CFR Part 50.109. However, NRC analyzed the accident-resistant

packaging requirement for the specified LSA shipments and found that

there is an increase in overall protection to be derived from the

requirement and that direct and indirect costs of implementation are

justified in view of this increased protection.

The factors normally considered in a backfit analysis are evaluated

in the ``Regulatory Analysis of Changes to 10 CFR Part 71--NRC

Regulations on Packaging and Transportation of Radioactive Material,''

dated April 1995. That evaluation shows very small changes in accident

risks as a result of the adoption of the revision, but some reduction

in maximum consequences given an accident. The evaluation shows broad

improvement in NRC regulatory consistency with IAEA, at an initial cost

of $1.375 million to industry, and continual annual costs to industry

of $1.0 million (See Table S.1 of Regulatory Analysis). NRC costs are

estimated at $0.463 million.

The continuing costs are associated with the addition of new limits

on the quantity of LSA radioactive material allowed in a single

transportation package. Internationally, a new limit is considered to

be a necessary safety requirement to limit the consequences of a severe

transportation accident involving LSA material.

The one-time costs are chiefly associated with industry upgrading

of its package safety analyses to include the proposed new accident

crush and immersion tests and with NRC review of those new analyses.

The estimated costs are overstated because of the assumption that all

licensees using packages approved under earlier regulatory standards

would take immediate steps to upgrade the package analyses so the

package approvals would reflect approval, under the latest revised

standards. Although that is a prudent assumption, absent any reasonable

basis for predicting actual licensee reaction, there is little reason

licensees would take any immediate action to upgrade their package

approvals. Both domestic and international regulations are based on the

responsible agency's confidence that packages built to a design

approved under earlier standards are adequately safe for continued use,

although new package construction to that design would be limited, and

international use requires approval by all countries through which the

package is to be transported. In actual practice, some package

approvals would never be upgraded. Those that would be upgraded would

be done over a period of several years as guidance and experience in

upgrading become available.

Although the regulatory analysis shows a small reduction in

accident risks from the amendments to this rule and some reduction in

maximum consequences given an accident, the primary benefit of this

rulemaking is to achieve consistency in radioactive material

transportation regulations between the United States and the rest of

the world. This consistency would not only facilitate the free movement

of radioactive materials between countries for medical, research,

industrial, and nuclear fuel cycle purposes, but it would also

contribute to safety by concentrating the efforts of the world's

experts on a single set of safety standards and guidance (those of the

IAEA) from which individual countries could develop their domestic

regulations. In addition, the accident experience of every country that

bases its domestic regulations on those of the IAEA could be applied to

every other country with consistent regulations to improve its safety

program.

In summary, the effort to make U.S. regulations compatible with

those of the IAEA provides major benefits including

[[Page 50264]]

a substantial increase in the overall protection of the public health

and safety, and it is associated with short-term and relatively minor

costs that are justified in view of this increased protection. This

effort is associated with ongoing costs, but the new limit is

considered to be a justified safety requirement, to limit the

consequences of a severe transportation accident involving LSA

material.

List of Subjects in 10 CFR Part 71

Criminal penalties, Hazardous materials transportation, Nuclear

materials, Packaging and containers, Reporting and recordkeeping

requirements.

For the reasons set out in the preamble and under the authority of

the Atomic Energy Act of 1954, as amended, the Energy Reorganization

Act of 1974, as amended, and 5 U.S.C. 552 and 553, 10 CFR part 71 is

revised to read as follows:

PART 71--PACKAGING AND TRANSPORTATION OF RADIOACTIVE MATERIAL

Subpart A--General Provisions

Sec.

71.0 Purpose and scope.

71.1 Communications and records.

71.2 Interpretations.

71.3 Requirement for license.

71.4 Definitions.

71.5 Transportation of licensed material.

Subpart B--Exemptions

71.6 Information collection requirements: OMB approval.

71.7 Completeness and accuracy of information.

71.8 Specific exemptions.

71.9 Exemption of physicians.

71.10 Exemption for low-level materials.

71.11 [Reserved]

Subpart C--General Licenses

71.12 General license: NRC-approved package.

71.13 Previously approved package.

71.14 General license: DOT specification container.

71.16 General license: Use of foreign approved package.

71.18 General license: Fissile material, limited quantity per

package.

71.20 General license: Fissile material, limited moderator per

package.

71.22 General license: Fissile material, limited quantity,

controlled shipment.

71.24 General license: Fissile material, limited moderator,

controlled shipment.

Subpart D--Application for Package Approval

71.31 Contents of application.

71.33 Package description.

71.35 Package evaluation.

71.37 Quality assurance.

71.38 Renewal of a certificate of compliance or quality assurance

program approval.

71.39 Requirement for additional information.

Subpart E--Package Approval Standards

71.41 Demonstration of compliance.

71.43 General standards for all packages.

71.45 Lifting and tie-down standards for all packages.

71.47 External radiation standards for all packages.

71.51 Additional requirements for Type B packages.

71.52 Exemption for low-specific-activity (LSA) packages.

71.53 Fissile material exemptions.

71.55 General requirements for fissile material packages.

71.57 [Reserved]

71.59 Standards for arrays of fissile material packages.

71.61 Special requirement for irradiated nuclear fuel shipments.

71.63 Special requirements for plutonium shipments.

71.64 Special requirements for plutonium air shipments.

71.65 Additional requirements.

Subpart F--Package, Special Form, and LSA-III Tests

71.71 Normal conditions of transport.

71.73 Hypothetical accident conditions.

71.74 Accident conditions for air transport of plutonium.

71.75 Qualification of special form radioactive material.

71.77 Qualification of LSA-III Material

Subpart G--Operating Controls and Procedures

71.81 Applicability of operating controls and procedures.

71.83 Assumptions as to unknown properties.

71.85 Preliminary determinations.

71.87 Routine determinations.

71.88 Air transport of plutonium.

71.89 Opening instructions.

71.91 Records.

71.93 Inspection and tests.

71.95 Reports.

71.97 Advance notification of shipment of irradiated reactor fuel

and nuclear waste.

71.99 Violations.

71.100 Criminal penalties.

Subpart H--Quality Assurance

71.101 Quality assurance requirements.

71.103 Quality assurance organization.

71.105 Quality assurance program.

71.107 Package design control.

71.109 Procurement document control.

71.111 Instructions, procedures, and drawings.

71.113 Document control.

71.115 Control of purchased material, equipment, and services.

71.117 Identification and control of materials, parts, and

components.

71.119 Control of special processes.

71.121 Internal inspection.

71.123 Test control.

71.125 Control of measuring and test equipment.

71.127 Handling, storage, and shipping control.

71.129 Inspection, test, and operating status.

71.131 Nonconforming materials, parts, or components.

71.133 Corrective action.

71.135 Quality assurance records.

71.137 Audits.

Appendix A to Part 71--Determination of A1 and A2

Authority: Secs. 53, 57, 62, 63, 81, 161, 182, 183, 68 Stat.

930, 932, 933, 935, 948, 953, 954, as amended, sec. 1701, 106 Stat.

2951, 2952, 2953 (42 U.S.C. 2073, 2077, 2092, 2093, 2111, 2201,

2232, 2233, 2297f); secs. 201, as amended, 202, 206, 88 Stat. 1242,

as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846).

Section 71.97 also issued under sec. 301, Pub. L. 96-295, 94

Stat. 789-790.

Subpart A--General Provisions

Sec. 71.0 Purpose and scope.

(a) This part establishes--

(1) Requirements for packaging, preparation for shipment, and

transportation of licensed material; and

(2) Procedures and standards for NRC approval of packaging and

shipping procedures for fissile material and for a quantity of other

licensed material in excess of a Type A quantity.

(b) The packaging and transport of licensed material are also

subject to other parts of this chapter (e.g., 10 CFR parts 20, 21, 30,

40, 70, and 73) and to the regulations of other agencies (e.g., the

U.S. Department of Transportation (DOT) and the U.S. Postal Service

1) having jurisdiction over means of transport. The requirements

of this part are in addition to, and not in substitution for, other

requirements.

\1\ Postal Service Manual (Domestic Mail Manual), section 124.3,

which is incorporated by reference at 39 CFR 111.1.

---------------------------------------------------------------------------

(c) The regulations in this part apply to any licensee authorized

by specific or general license issued by the Commission to receive,

possess, use, or transfer licensed material, if the licensee delivers

that material to a carrier for transport, transports the material

outside the site of usage as specified in the NRC license, or

transports that material on public highways. No provision of this part

authorizes possession of licensed material.

(d) Exemptions from the requirement for license in Sec. 71.3 are

specified in Sec. 71.10. General licenses for which no NRC package

approval is required are issued in Secs. 71.14 through 71.24. The

general license in Sec. 71.12 requires that an NRC certificate of

compliance or other package approval be issued for the package to be

used under the general license. Application for package

[[Page 50265]]

approval must be completed in accordance with subpart D of this part,

demonstrating that the design of the package to be used satisfies the

package approval standards contained in subpart E of this part, as

related to the tests of subpart F of this part. The transport of

licensed material or delivery of licensed material to a carrier for

transport is subject to the operating controls and procedures

requirements of subpart G of this part, to the quality assurance

requirements of subpart H of this part, and to the general provisions

of subpart A of this part, including DOT regulations referenced in

Sec. 71.5.

(e) The regulations in this part apply to any person required to

obtain a certificate of compliance or an approved compliance plan

pursuant to part 76 of this chapter if the person delivers radioactive

material to a common or contract carrier for transport or transports

the material outside the confines of the person's plant or other

authorized place of use.

Sec. 71.1 Communications and records.

(a) All communications concerning the regulations in this part

should be addressed to the Director, Office of Nuclear Material Safety

and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC

20555-0001, or may be delivered in person, at the Commission offices,

at 11545 Rockville Pike, Rockville, Maryland.

(b) Each record required by this part must be legible throughout

the retention period specified by each Commission regulation. The

record may be the original or a reproduced copy or a microform provided

that the copy or microform is authenticated by authorized personnel and

that the microform is capable of producing a clear copy throughout the

required retention period. The record may also be stored in electronic

media with the capability for producing legible, accurate, and complete

records during the required retention period. Records such as letters,

drawings, specifications, must include all pertinent information such

as stamps, initials, and signatures. The licensee shall maintain

adequate safeguards against tampering with and loss of records.

Sec. 71.2 Interpretations.

Except as specifically authorized by the Commission in writing, no

interpretation of the meaning of the regulations in this part by any

officer or employee of the Commission, other than a written

interpretation by the General Counsel, will be recognized to be binding

upon the Commission.

Sec. 71.3 Requirement for license.

Except as authorized in a general license or a specific license

issued by the Commission, or as exempted in this part, no licensee

may--

(a) Deliver licensed material to a carrier for transport; or

(b) Transport licensed material.

Sec. 71.4 Definitions.

The following terms are as defined here for the purpose of this

part. To ensure compatibility with international transportation

standards, all limits in this part are given in terms of dual units:

The International System of Units (SI) followed or preceded by U.S.

standard or customary units. The U.S. customary units are not exact

equivalents, but are rounded to a convenient value, providing a

functionally equivalent unit. For the purpose of this part, either unit

may be used.

A1 means the maximum activity of special form radioactive

material permitted in a Type A package. A2 means the maximum

activity of radioactive material, other than special form, LSA and SCO

material, permitted in a Type A package. These values are either listed

in Appendix A of this part, Table A-1, or may be derived in accordance

with the procedure prescribed in Appendix A of this part.

Carrier means a person engaged in the transportation of passengers

or property by land or water as a common, contract, or private carrier,

or by civil aircraft.

Certificate holder means a person who has been issued a certificate

of compliance or other package approval by the Commission.

Close reflection by water means immediate contact by water of

sufficient thickness for maximum reflection of neutrons.

Containment system means the assembly of components of the

packaging intended to retain the radioactive material during transport.

Conveyance means:

(1) For transport by public highway or rail any transport vehicle

or large freight container;

(2) For transport by water any vessel, or any hold, compartment, or

defined deck area of a vessel including any transport vehicle on board

the vessel; and

(3) For transport by aircraft any aircraft.

Exclusive use means the sole use by a single consignor of a

conveyance for which all initial, intermediate, and final loading and

unloading are carried out in accordance with the direction of the

consignor or consignee. The consignor and the carrier must ensure that

any loading or unloading is performed by personnel having radiological

training and resources appropriate for safe handling of the

consignment. The consignor must issue specific instructions, in

writing, for maintenance of exclusive use shipment controls, and

include them with the shipping paper information provided to the

carrier by the consignor.

Fissile material means plutonium-238, plutonium-239, plutonium-241,

uranium-233, uranium-235, or any combination of these radionuclides.

Unirradiated natural uranium and depleted uranium, and natural uranium

or depleted uranium that has been irradiated in thermal reactors only

are not included in this definition. Certain exclusions from fissile

material controls are provided in Sec. 71.53.

Licensed material means by-product, source, or special nuclear

material received, possessed, used, or transferred under a general or

specific license issued by the Commission pursuant to the regulations

in this chapter.

Low Specific Activity (LSA) material means radioactive material

with limited specific activity that satisfies the descriptions and

limits set forth below. Shielding materials surrounding the LSA

material may not be considered in determining the estimated average

specific activity of the package contents. LSA material must be in one

of three groups:

(1) LSA-I.

(i) Ores containing only naturally occurring radionuclides (e.g.,

uranium, thorium) and uranium or thorium concentrates of such ores; or

(ii) Solid unirradiated natural uranium or depleted uranium or

natural thorium or their solid or liquid compounds or mixtures; or

(iii) Radioactive material, other than fissile material, for which

the A2 value is unlimited; or

(iv) Mill tailings, contaminated earth, concrete, rubble, other

debris, and activated material in which the radioactive material is

essentially uniformly distributed, and the average specific activity

does not exceed 10-6 A2/g.

(2) LSA-II.

(i) Water with tritium concentration up to 0.8 TBq/liter (20.0 Ci/

liter); or

(ii) Material in which the radioactive material is essentially

uniformly distributed, and the average specific activity does not

exceed 10-4 A2/g for solids and gases, and 10-5 A2/

g for liquids.

(3) LSA-III. Solids (e.g., consolidated wastes, activated

materials) in which:

(i) The radioactive material is essentially uniformly distributed

[[Page 50266]]

throughout a solid or a collection of solid objects, or is essentially

uniformly distributed in a solid compact binding agent (such as

concrete, bitumen, ceramic, etc.);

(ii) The radioactive material is relatively insoluble, or it is

intrinsically contained in a relatively insoluble material, so that,

even under loss of packaging, the loss of radioactive material per

package by leaching, when placed in water for 7 days, would not exceed

0.1 A2; and

(iii) The average specific activity of the solid does not exceed 2

x 10-3

A2/g.

Low toxicity alpha emitters means natural uranium, depleted

uranium, natural thorium; uranium-235, uranium-238, thorium-232,

thorium-228 or thorium-230 when contained in ores or physical or

chemical concentrates or tailings; or alpha emitters with a half-life

of less than 10 days.

Maximum normal operating pressure means the maximum gauge pressure

that would develop in the containment system in a period of 1 year

under the heat condition specified in Sec. 71.71(c)(1), in the absence

of venting, external cooling by an ancillary system, or operational

controls during transport.

Natural thorium means thorium with the naturally occurring

distribution of thorium isotopes (essentially 100 weight percent

thorium-232).

Normal form radioactive material means radioactive material that

has not been demonstrated to qualify as ``special form radioactive

material.''

Optimum interspersed hydrogenous moderation means the presence of

hydrogenous material between packages to such an extent that the

maximum nuclear reactivity results.

Package means the packaging together with its radioactive contents

as presented for transport.

(1) Fissile material package means a fissile material packaging

together with its fissile material contents.

(2) Type B package means a Type B packaging together with its

radioactive contents. On approval, a Type B package design is

designated by NRC as B(U) unless the package has a maximum normal

operating pressure of more than 700 kPa (100 lb/in2) gauge or a

pressure relief device that would allow the release of radioactive

material to the environment under the tests specified in Sec. 71.73

(hypothetical accident conditions), in which case it will receive a

designation B(M). B(U) refers to the need for unilateral approval of

international shipments; B(M) refers to the need for multilateral

approval of international shipments. There is no distinction made in

how packages with these designations may be used in domestic

transportation. To determine their distinction for international

transportation, see DOT regulations in 49 CFR Part 173. A Type B

package approved before September 6, 1983, was designated only as Type

B. Limitations on its use are specified in Sec. 71.13.

Packaging means the assembly of components necessary to ensure

compliance with the packaging requirements of this part. It may consist

of one or more receptacles, absorbent materials, spacing structures,

thermal insulation, radiation shielding, and devices for cooling or

absorbing mechanical shocks. The vehicle, tie-down system, and

auxiliary equipment may be designated as part of the packaging.

Special form radioactive material means radioactive material that

satisfies the following conditions:

(1) It is either a single solid piece or is contained in a sealed

capsule that can be opened only by destroying the capsule;

(2) The piece or capsule has at least one dimension not less than 5

mm (0.2 in); and

(3) It satisfies the requirements of Sec. 71.75. A special form

encapsulation designed in accordance with the requirements of Sec. 71.4

in effect on June 30, 1983, (see 10 CFR part 71, revised as of January

1, 1983), and constructed before July 1, 1985, and a special form

encapsulation designed in accordance with the requirements of Sec. 71.4

in effect on March 31, 1996, (see 10 CFR part 71, revised as of January

1, 1983), and constructed before April 1, 1998, may continue to be

used. Any other special form encapsulation must meet the specifications

of this definition.

Specific activity of a radionuclide means the radioactivity of the

radionuclide per unit mass of that nuclide. The specific activity of a

material in which the radionuclide is essentially uniformly distributed

is the radioactivity per unit mass of the material.

State means a State of the United States, the District of Columbia,

the Commonwealth of Puerto Rico, the Virgin Islands, Guam, American

Samoa, and the Commonwealth of the Northern Mariana Islands.

Surface Contaminated Object (SCO) means a solid object that is not

itself classed as radioactive material, but which has radioactive

material distributed on any of its surfaces. SCO must be in one of two

groups with surface activity not exceeding the following limits:

(1) SCO-I: A solid object on which:

(i) The non-fixed contamination on the accessible surface averaged

over 300 cm2 (or the area of the surface if less than 300

cm2) does not exceed 4 Bq/cm2 (10-4 microcurie/cm2)

for beta and gamma and low toxicity alpha emitters, or 0.4 Bq/cm2

(10-5 microcurie/cm2) for all other alpha emitters;

(ii) The fixed contamination on the accessible surface averaged

over 300 cm2 (or the area of the surface if less than 300

cm2) does not exceed 4x104 Bq/cm2 (1.0 microcurie/

cm2) for beta and gamma and low toxicity alpha emitters, or

4x103 Bq/cm2 (0.1 microcurie/cm2) for all other alpha

emitters; and

(iii) The non-fixed contamination plus the fixed contamination on

the inaccessible surface averaged over 300 cm2 (or the area of the

surface if less than 300 cm2) does not exceed 4x104 Bq/

cm2 (1 microcurie/cm2) for beta and gamma and low toxicity

alpha emitters, or 4x103 Bq/cm2 (0.1 microcurie/cm2) for

all other alpha emitters.

(2) SCO-II: A solid object on which the limits for SCO-I are

exceeded and on which:

(i) The non-fixed contamination on the accessible surface averaged

over 300 cm\2\ (or the area of the surface if less than 300 cm\2\) does

not exceed 400 Bq/cm\2\ (10-2 microcurie/cm\2\) for beta and gamma

and low toxicity alpha emitters or 40 Bq/cm\2\ (10-3 microcurie/

cm\2\) for all other alpha emitters;

(ii) The fixed contamination on the accessible surface averaged

over 300 cm\2\ (or the area of the surface if less than 300 cm\2\) does

not exceed 8 x 10\5\ Bq/cm\2\ (20 microcuries/cm\2\) for beta and gamma

and low toxicity alpha emitters, or 8 x 10 \4\ Bq/cm\2\ (2 microcuries/

cm\2\) for all other alpha emitters; and

(iii) The non-fixed contamination plus the fixed contamination on

the inaccessible surface averaged over 300 cm\2\ (or the area of the

surface if less than 300 cm\2\) does not exceed 8 x 10\5\ Bq/cm\2\ (20

microcuries/cm\2\) for beta and gamma and low toxicity alpha emitters,

or 8 x 10\4\ Bq/cm\2\ (2 microcuries/cm\2\) for all other alpha

emitters.

Transport index means the dimensionless number (rounded up to the

next tenth) placed on the label of a package, to designate the degree

of control to be exercised by the carrier during transportation. The

transport index is determined as follows:

(1) For non-fissile material packages, the number determined by

multiplying the maximum radiation level in millisievert (mSv) per hour

at one meter (3.3 ft) from the external surface of the package by 100

(equivalent to the

[[Page 50267]]

maximum radiation level in millirem per hour at one meter (3.3 ft)); or

(2) For fissile material packages, the number determined by

multiplying the maximum radiation level in millisievert per hour at one

meter (3.3 ft) from the external surface of the package by 100

(equivalent to the maximum radiation level in millirem per hour at one

meter (3.3 ft)), or, for criticality control purposes, the number

obtained as described in Sec. 71.59, whichever is larger.

Type A quantity means a quantity of radioactive material, the

aggregate radioactivity of which does not exceed A1 for special

form radioactive material, or A2, for normal form radioactive

material, where A1 and A2 are given in Table A-1 of this

part, or may be determined by procedures described in Appendix A of

this part.

Type B quantity means a quantity of radioactive material greater

than a Type A quantity.

Uranium--natural, depleted, enriched

(1) Natural uranium means uranium with the naturally occurring

distribution of uranium isotopes (approximately 0.711 weight percent

uranium-235, and the remainder by weight essentially uranium-238).

(2) Depleted uranium means uranium containing less uranium-235 than

the naturally occurring distribution of uranium isotopes.

(3) Enriched uranium means uranium containing more uranium-235 than

the naturally occurring distribution of uranium isotopes.

Sec. 71.5 Transportation of licensed material.

(a) Each licensee who transports licensed material outside the site

of usage, as specified in the NRC license, or where transport is on

public highways, or who delivers licensed material to a carrier for

transport, shall comply with the applicable requirements of the DOT

regulations in 49 CFR parts 170 through 189 appropriate to the mode of

transport.

(1) The licensee shall particularly note DOT regulations in the

following areas:

(i) Packaging--49 CFR part 173: Subparts A and B and I.

(ii) Marking and labeling--49 CFR part 172: Subpart D,

Secs. 172.400 through 172.407, Secs. 172.436 through 172.440, and

subpart E.

(iii) Placarding--49 CFR part 172: Subpart F, especially

Secs. 172.500 through 172.519, 172.556, and appendices B and C.

(iv) Accident reporting--49 CFR part 171: Secs. 171.15 and 171.16.

(v) Shipping papers and emergency information--49 CFR part 172:

Subparts C and G.

(vi) Hazardous material employee training--49 CFR part 172: Subpart

H.

(vii) Hazardous material shipper/carrier registration--49 CFR part

107: Subpart G.

(2) The licensee shall also note DOT regulations pertaining to the

following modes of transportation:

(i) Rail--49 CFR part 174: Subparts A through D and K.

(ii) Air--49 CFR part 175.

(iii) Vessel--49 CFR part 176: Subparts A through F and M.

(iv) Public Highway--49 CFR part 177 and parts 390 through 397.

(b) If DOT regulations are not applicable to a shipment of licensed

material, the licensee shall conform to the standards and requirements

of the DOT specified in paragraph (a) of this section to the same

extent as if the shipment or transportation were subject to DOT

regulations. A request for modification, waiver, or exemption from

those requirements, and any notification referred to in those

requirements, must be filed with, or made to, the Director, Office of

Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory

Commission, Washington, DC 20555-0001.

Subpart B--Exemptions

Sec. 71.6 Information collection requirements: OMB approval.

(a) The Nuclear Regulatory Commission has submitted the information

collection requirements contained in this part to the Office of

Management and Budget (OMB) for approval, as required by the Paperwork

Reduction Act of 1980 (44 U.S.C. 3501 et seq.). OMB has approved the

information collection requirements contained in this part, under

control number 3150-0008.

(b) The approved information collection requirements contained in

this part appear in Secs. 71.5, 71.6a, 71.7, 71.12, 71.13, 71.31,

71.33, 71.35, 71.37, 71.38, 71.39, 71.47, 71.85, 71.87, 71.89, 71.91,

71.93, 71.95, 71.97, 71.101, 71.103, 71.105, 71.107, 71.109, 71.111,

71.113, 71.115, 71.117, 71.119, 71.121, 71.123, 71.125, 71.127, 71.129,

71.131, 71.133, 71.135, and 71.137.

Sec. 71.7 Completeness and accuracy of information.

(a) Information provided to the Commission by an applicant for a

license, or by a licensee, or information required by statute or by the

Commission's regulations, orders, or license conditions to be

maintained by the applicant or the licensee must be complete and

accurate in all material respects.

(b) Each applicant or licensee shall notify the Commission of

information identified by the applicant or licensee as having, for the

regulated activity, a significant implication for public health and

safety or common defense and security. An applicant or licensee

violates this requirement only if the applicant or licensee fails to

notify the Commission of information that the applicant or licensee has

identified as having a significant implication for public health and

safety or common defense and security. Notification must be provided to

the Administrator of the appropriate Regional Office within two working

days of identifying the information. This requirement is not applicable

to information that is already required to be provided to the

Commission by other reporting or updating requirements.

Sec. 71.8 Specific exemptions.

On application of any interested person or on its own initiative,

the Commission may grant any exemption from the requirements of the

regulations in this part that it determines is authorized by law and

will not endanger life or property nor the common defense and security.

Sec. 71.9 Exemption of physicians.

Any physician licensed by a State to dispense drugs in the practice

of medicine is exempt from Sec. 71.5 with respect to transport by the

physician of licensed material for use in the practice of medicine.

However, any physician operating under this exemption must be licensed

under 10 CFR part 35 or the equivalent Agreement State regulations.

Sec. 71.10 Exemption for low-level materials.

(a) A licensee is exempt from all requirements of this part with

respect to shipment or carriage of a package containing radioactive

material having a specific activity not greater than 70 Bq/g (0.002

Ci/g).

(b) A licensee is exempt from all requirements of this part, other

than Sec. 71.5 and Sec. 71.88, with respect to shipment or carriage of

the following packages, provided the packages contain no fissile

material, or the fissile material exemption standards of Sec. 71.53 are

satisfied:

(1) A package containing no more than a Type A quantity of

radioactive material;

(2) A package in which the only radioactive material is low

specific activity (LSA) material or surface contaminated objects (SCO),

provided the external radiation level at 3 m from the unshielded

material or objects does not exceed 10 mSv/h (1 rem/h); or

[[Page 50268]]

(3) A package transported within locations within the United States

which contains only americium or plutonium in special form with an

aggregate radioactivity not to exceed 20 curies.

(c) A licensee is exempt from all requirements of this part, other

than Secs. 71.5 and 71.88, with respect to shipment or carriage of low-

specific-activity (LSA) material in group LSA-I, or surface

contaminated objects (SCOs) in group SCO-I.

Sec. 71.11 [Reserved]

Subpart C--General Licenses

Sec. 71.12 General license: NRC-approved package.

(a) A general license is hereby issued to any licensee of the

Commission to transport, or to deliver to a carrier for transport,

licensed material in a package for which a license, certificate of

compliance, or other approval has been issued by the NRC.

(b) This general license applies only to a licensee who has a

quality assurance program approved by the Commission as satisfying the

provisions of subpart H of this part.

(c) This general license applies only to a licensee who--

(1) Has a copy of the certificate of compliance, or other approval

of the package, and has the drawings and other documents referenced in

the approval relating to the use and maintenance of the packaging and

to the actions to be taken before shipment;

(2) Complies with the terms and conditions of the license,

certificate, or other approval, as applicable, and the applicable

requirements of subparts A, G, and H of this part; and

(3) Submits in writing to the Director, Office of Nuclear Material

Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington,

DC 20555-0001, before the licensee's first use of the package, the

licensee's name and license number and the package identification

number specified in the package approval.

(d) This general license applies only when the package approval

authorizes use of the package under this general license.

(e) For a Type B or fissile material package, the design of which

was approved by NRC before April 1, 1996, the general license is

subject to the additional restrictions of Sec. 71.13.

Sec. 71.13 Previously approved package.

(a) A Type B package previously approved by NRC but not designated

as B(U) or B(M) in the identification number of the NRC Certificate of

Compliance, may be used under the general license of Sec. 71.12 with

the following additional conditions:

(1) Fabrication of the packaging was satisfactorily completed by

August 31, 1986, as demonstrated by application of its model number in

accordance with Sec. 71.85(c);

(2) A package used for a shipment to a location outside the United

States is subject to multilateral approval, as defined in DOT

regulations at 49 CFR 173.403; and

(3) A serial number that uniquely identifies each packaging which

conforms to the approved design is assigned to, and legibly and durably

marked on, the outside of each packaging.

(b) A Type B(U) package, a Type B(M) package, a low specific

activity (LSA) material package or a fissile material package,

previously approved by the NRC but without the designation ``-85'' in

the identification number of the NRC Certificate of Compliance, may be

used under the general license of Sec. 71.12 with the following

additional conditions:

(1) Fabrication of the package is satisfactorily completed by April

1, 1999 as demonstrated by application of its model number in

accordance with Sec. 71.85(c);

(2) A package used for a shipment to a location outside the United

States is subject to multilateral approval as defined in DOT

regulations at 49 CFR 173.403; and

(3) A serial number which uniquely identifies each packaging which

conforms to the approved design is assigned to and legibly and durably

marked on the outside of each packaging.

(c) NRC will approve modifications to the design and authorized

contents of a Type B package, or a fissile material package, previously

approved by NRC, provided--

(1) The modifications of a Type B package are not significant with

respect to the design, operating characteristics, or safe performance

of the containment system, when the package is subjected to the tests

specified in Secs. 71.71 and 71.73;

(2) The modifications of a fissile material package are not

significant, with respect to the prevention of criticality, when the

package is subjected to the tests specified in Secs. 71.71 and 71.73;

and

(3) The modifications to the package satisfy the requirements of

this part.

(d) NRC will revise the package identification number to designate

previously approved package designs as B(U), B(M), AF, BF, or A as

appropriate, and with the identification number suffix ``-85'' after

receipt of an application demonstrating that the design meets the

requirements of this part.

Sec. 71.14 General license: DOT specification container.

(a) A general license is issued to any licensee of the Commission

to transport, or to deliver to a carrier for transport, licensed

material in a specification container for fissile material or for a

Type B quantity of radioactive material as specified in DOT regulations

at 49 CFR parts 173 and 178.

(b) This general license applies only to a licensee who has a

quality assurance program approved by the Commission as satisfying the

provisions of subpart H of this part.

(c) This general license applies only to a licensee who--

(1) Has a copy of the specification; and

(2) Complies with the terms and conditions of the specification and

the applicable requirements of subparts A, G, and H of this part.

(d) This general license is subject to the limitation that the

specification container may not be used for a shipment to a location

outside the United States, except by multilateral approval, as defined

in DOT regulations at 49 CFR 173.403.

Sec. 71.16 General License: Use of foreign approved package.

(a) A general license is issued to any licensee of the Commission

to transport, or to deliver to a carrier for transport, licensed

material in a package the design of which has been approved in a

foreign national competent authority certificate that has been

revalidated by DOT as meeting the applicable requirements of 49 CFR

171.12.

(b) Except as otherwise provided in this section, the general

license applies only to a licensee who has a quality assurance program

approved by the Commission as satisfying the applicable provisions of

subpart H of this part.

(c) This general license applies only to shipments made to or from

locations outside the United States.

(d) This general license applies only to a licensee who--

(1) Has a copy of the applicable certificate, the revalidation, and

the drawings and other documents referenced in the certificate,

relating to the use and maintenance of the packaging and to the actions

to be taken before shipment; and

(2) Complies with the terms and conditions of the certificate and

revalidation, and with the applicable requirements of subparts A, G,

and H of

[[Page 50269]]

this part. With respect to the quality assurance provisions of subpart

H of this part, the licensee is exempt from design, construction, and

fabrication considerations.

Sec. 71.18 General license: Fissile material, limited quantity per

package.

(a) A general license is issued to any licensee of the Commission

to transport fissile material, or to deliver fissile material to a

carrier for transport, without complying with the package standards of

subparts E and F of this part, if the material is shipped in accordance

with this section.

(b) The general license applies only to a licensee who has a

quality assurance program approved by the Commission as satisfying the

provisions of subpart H of this part.

(c) This general license applies only when a package contains no

more than a Type A quantity of radioactive material, including only one

of the following:

(1) Up to 40 g of uranium-235;

(2) Up to 30 g of uranium-233;

(3) Up to 25 g of the fissile radionuclides of plutonium, except

that for encapsulated plutonium-beryllium neutron sources in special

form, an A1 quantity of plutonium may be present; or

(4) A combination of fissile radionuclides in which the sum of the

ratios of the amount of each radionuclide to the corresponding maximum

amounts in paragraphs (c)(1), (2), and (3) of this section does not

exceed unity.

(d) (1) This general license applies only when, except as specified

below for encapsulated plutonium-beryllium sources, a package

containing more than 15 g of fissile radionuclides is labeled with a

transport index not less than the number given by the following

equation, where the package contains x grams of uranium-235, y grams of

uranium-233, and z grams of the fissile radionuclides of plutonium:

Minimum Transport Index = (0.40x+0.67y+z) (1-15 ).x+y+z

(2) For a package in which the only fissile material is in the form

of encapsulated plutonium-beryllium neutron sources in special form,

the transport index based on criticality considerations may be taken as

0.026 times the number of grams of the fissile radionuclides of

plutonium in excess of 15 g. In all cases, the transport index must be

rounded up to one decimal place and may not exceed 10.0.

Sec. 71.20 General license: Fissile material, limited moderator per

package.

(a) A general license is issued to any licensee of the Commission

to transport fissile material, or to deliver fissile material to a

carrier for transport, without complying with the package standards of

subparts E and F of this part if the material is shipped in accordance

with this section.

(b) The general license applies only to a licensee who has a

quality assurance program approved by the Commission as satisfying the

provisions of subpart H of this part.

(c) This general license applies only when--

(1) The package contains no more than a Type A quantity of

radioactive material;

(2) Neither beryllium nor hydrogenous material enriched in

deuterium is present;

(3) The total mass of graphite present does not exceed 7.7 times

the total mass of uranium-235 plus plutonium;

(4) Substances having a higher hydrogen density than water (e.g.,

certain hydrocarbon oils), are not present, except that polyethylene

may be used for packing or wrapping;

(5) Uranium-233 is not present, and the amount of plutonium does

not exceed 1 percent of the amount of uranium-235;

(6) The amount of uranium-235 is limited as follows:

(i) If the fissile radionuclides are not uniformly distributed, the

maximum amount of uranium-235 per package may not exceed the value

given in Table I of this part; or

(ii) If the fissile radionuclides are distributed uniformly (i.e.,

cannot form a lattice arrangement within the packaging), the maximum

amount of uranium-235 per package may not exceed the value given in

Table II of this part; and

(7) The transport index of each package, based on criticality

considerations, is taken as 10 times the number of grams of uranium-235

in the package divided by the maximum allowable number of grams per

package in accordance with Table I or Table II of this part, as

applicable.

Table I.--Permissible Mass of Uranium-235 per Fissile Material Package,

Applicable to Sec. 71.20(c)(6)(i)

[Nonuniform distribution]

------------------------------------------------------------------------

Permissible

maximum

Uranium enrichment in weight percent of uranium-235 not grams of

exceeding uranium-235

per package

------------------------------------------------------------------------

24......................................................... 40

20......................................................... 42

15......................................................... 45

11......................................................... 48

10......................................................... 51

9.5........................................................ 52

9.......................................................... 54

8.5........................................................ 55

8.......................................................... 57

7.5........................................................ 59

7.......................................................... 60

6.5........................................................ 62

6.......................................................... 65

5.5........................................................ 68

5.......................................................... 72

4.5........................................................ 76

4.......................................................... 80

3.5........................................................ 88

3.......................................................... 100

2.5........................................................ 120

2.......................................................... 164

1.5........................................................ 272

1.35....................................................... 320

1.......................................................... 680

0.92....................................................... 1,200

------------------------------------------------------------------------

Table II.--Permissible Mass of Uranium-235 per Fissile Material Package,

Applicable to Sec. 71.20(c)(6)(ii)

[Uniform Distribution]

------------------------------

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