Hazardous Materials: Radiation Protection Program Requirement

DEPARTMENT OF TRANSPORTATION

Research and Special Programs Administration

49 CFR Part 172

[Docket No. RSPA-97-2850 (HM-169B)]

RIN 2137-AD14

Hazardous Materials: Radiation Protection Program Requirement

AGENCY: Research and Special Programs Administration (RSPA), DOT.

ACTION: Final Rule; extension of compliance date.

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SUMMARY: RSPA is extending until October 1, 1999, the date for

mandatory compliance with the Radiation Protection Program (RPP)

requirements adopted in the final rule issued September 28, 1995.

During this period, RSPA intends to consider in a separate rulemaking

whether the RPP requirements should be withdrawn or revised because of

the difficulties and complexities concerning implementation of and

compliance with the RPP requirements. RSPA believes that compliance

should not be required with requirements that may be withdrawn or

substantially revised, and that overall safety in the transportation of

radioactive materials will be advanced by reexamining the RPP

requirements before requiring compliance with the current requirements.

EFFECTIVE DATE: December 22, 1997.

FOR FURTHER INFORMATION CONTACT: Dr. Fred Ferate II, Office of

Hazardous Materials Technology, 202-366-4545, or Charles E. Betts,

Office of Hazardous Materials Standards, 202-366-8553, RSPA, U.S.

Department of Transportation, 400 Seventh Street, SW, Washington, DC

20590-0001.

SUPPLEMENTARY INFORMATION: On September 28, 1995, RSPA published a

final rule in the Federal Register in this docket as part of RSPA's

ongoing effort to harmonize the Hazardous Materials Regulations (HMR),

49 CFR Parts 171-180, with international standards and to improve

safety for workers and the public during the transportation of

radioactive materials. (60 FR 50292). One of the substantive regulatory

changes in the September 28, 1995 final rule is the requirement to

develop and maintain a written radiation protection program (RPP).

The RPP requirements apply, with certain exceptions, to each person

who offers for transportation, accepts for transportation, or

transports Class 7 (radioactive) materials. The RPP

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requirements are set forth in Subpart I of Part 172 of the HMR.

Implementation provisions for rail, air, vessel, and highway are

contained in Secs. 174.705, 175.706, 176.703, and 177.827,

respectively. Compliance with the RPP requirements has been required

since October 1, 1997.

RSPA's regulatory evaluation prepared in support of the September

28, 1995 final rule considered that carriers would be primarily

affected by the RPP requirements. (Some carriers of radioactive

materials are already covered by monitoring requirements contained in

exemptions from quantity limitations in the HMR.) Many shippers of

radioactive material, especially those who are Department of Energy

contractors, or Nuclear Regulatory Commission or Agreement State

licensees, are already subject to RPP requirements, and the September

28, 1995 final rule provides that the RPP requirements are satisfied by

any radiation protection program that has been approved by an

appropriate Federal or State agency. 49 CFR 172.803(d)(2).

On May 8, 1996, RSPA published in the Federal Register editorial

corrections to the September 28, 1995 final rule and a denial of the

one petition for reconsideration (from the Radiopharmaceutical Shippers

and Carriers Conference [RSCC]) that had been timely filed. [61 FR

20747]. The editorial corrections included changes to Sec. 172.803.

In addition, on April 19, 1996, RSPA published in the Federal

Register a request for comments on the implementation of the RPP

requirements, in response to questions or comments expressing

difficulties in implementing or complying with the RPP requirements.

Notice 96-7 (61 FR 17349). In Notice 96-7, RSPA stated its intention to

develop guidance for the radioactive material industry to facilitate

compliance with the RPP requirements.

In response to Notice 96-7, RSPA received numerous comments, a new

petition for rulemaking from RSCC (that expanded upon its denied

petition for reconsideration), and three additional documents

purporting to be ``petitions for reconsideration'' of the September 28,

1995 final rule (which were treated as comments in response to Notice

96-7, rather than petitions for reconsideration, because they were not

submitted within 30 days after publication of the September 28, 1995

final rule). After considering these comments and petitions, RSPA

decided that the concerns expressed could not all be resolved through

guidance. The concerns were significant enough that RSPA determined it

would be preferable to withdraw the RPP requirements completely, and

reconsider this matter from the beginning, rather than try to amend

Subpart I before the upcoming October 1, 1997 compliance date.

For this reason, RSPA published a direct final rule on September 2,

1997, withdrawing the RPP requirements effective September 30, 1997,

unless (in accordance with RSPA's procedural rules at 49 CFR 106.39) an

adverse comment or notice of intent to file an adverse comment was

received by September 30, 1997. [62 FR 46214]. Because two persons

submitted adverse comments on the direct final rule, RSPA is publishing

a separate document, revoking the direct final rule and leaving the RPP

requirements in effect.

As noted above and in the direct final rule, many shippers of

radioactive materials are already subject to an RPP requirement. RSPA

considers that it may also be appropriate to establish in the HMR some

form of RPP requirement for carriers and any shippers not already

covered by other existing requirements, to provide a formal and

structured framework for ensuring safety during radioactive material

transportation activities. However, RSPA has also concluded that the

problems with the current RPP requirements in Subpart I of 49 CFR Part

172 are sufficiently great that compliance with them should not be

required while RSPA reconsiders this entire matter.

As a first step, RSPA intends to publish a notice of proposed

rulemaking (NPRM) in the near future to address the merits of all the

comments and petitions directed to the RPP requirements and to request

additional comments concerning the need to withdraw or revise the RPP

requirements. To allow this separate rulemaking to proceed in an

orderly fashion, without the threat of enforcement or liability based

on noncompliance, and in response to a request for a stay of the

compliance date from RSCC, RSPA is extending the date for mandatory

compliance with the RPP requirements until October 1, 1999. As also

discussed below, RSPA has concluded that a lack of approval by the

Office of Management and Budget (OMB) for information collection

requirements precludes Federal enforcement of the RPP requirements at

this time.

Regulatory Analyses and Notices

A. Executive Order 12866 and DOT Regulatory Policies and Procedures

This rule provides relief to persons who offer for transportation,

accept for transportation, or transport Class 7 (radioactive) materials

by extending until October 1, 1999, the requirement to develop and

maintain a radiation protection program. The effect of this rule is not

considered a significant regulatory action under Section 3(f) of

Executive Order 12866, and this rule was not reviewed by the Office of

Management and Budget. This rule is not considered significant under

the regulatory policies and procedures of the Department of

Transportation. [44 FR 11034 (February 26, 1979)].

RSPA has not prepared a regulatory evaluation that specifically

addresses the issue of extending the date for developing and

maintaining a radiation protection program. The regulatory evaluation

prepared in support of the September 28, 1995 final rule considered

that the health benefits to the transportation community of limiting

radiation exposures, through a radiation protection program, would be

significant. That regulatory evaluation also estimated that the

benefits of making U.S. regulations for the transportation of

radioactive materials consistent with international standards would

exceed the total estimated costs of the September 28, 1995 final rule

involved in converting to the international system of units (SI) and

meeting the RPP requirements. However, the costs of implementing the

RPP requirements will be greatly increased (and overall safety will

likely be reduced) if compliance with the current regulations is

required, then if these requirements are withdrawn or significantly

revised. RSPA, in support of the NPRM, will be preparing a regulatory

evaluation to address the issue of removing the radiation protection

program requirement from the HMR.

B. Executive Order 12612

This rule has been analyzed in accordance with the principles and

criteria contained in Executive Order 12612 (``Federalism''). The

Federal hazardous material transportation law contains express

preemption provisions at 49 U.S.C. 5125 that preempt State, local, and

Indian tribe requirements if

(1) Complying with a requirement of the State, political

subdivision, or Indian tribe and Federal hazardous material

transportation law or regulations is not possible;

(2) The requirement of the State, political subdivision, or Indian

tribe, as applied or enforced, is an obstacle to accomplishing and

carrying out Federal hazardous material transportation law or

regulations; or

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(3) The requirement of the State, political subdivision, or Indian

tribe concerns any of the following ``covered subjects'' and is not

substantially the same as a provision of Federal hazardous material

transportation law or regulations:

(A) The designation, description, and classification of hazardous

material;

(B) The packing, repacking, handling, labeling, marking, and

placarding of hazardous material;

(C) The preparation, execution, and use of shipping documents

related to hazardous material and requirements related to the number,

contents, and placement of those documents;

(D) The written notification, recording, and reporting of the

unintentional release in transportation of hazardous material; and

(E) The design, manufacture, fabricating, marking, maintenance,

reconditioning, repairing, or testing of a packaging or container

represented, marked, certified, or sold as qualified for use in

transporting hazardous material.

Federal law (49 U.S.C. 5125(b)(2) provides that if DOT issues a

regulation concerning any of the covered subjects, DOT must determine

and publish in the Federal Register the effective date of Federal

preemption. The effective date may not be earlier than the 90th day

following the date of issuance of the final rule and not later than two

years after the date of issuance.

RSPA is not aware of any State, local, or Indian tribe requirement

that would be preempted by an extension of the date for compliance with

the RPP requirements.

C. Regulatory Flexibility Act

The Regulatory Flexibility Act, 5 U.S.C. 601-612, directs agencies

to consider the potential impact of regulations on small business and

other small entities. In the regulatory evaluation originally prepared

to consider RPP requirements, RSPA estimated a total of 497 carriers

(primarily motor carriers) would be subject to these requirements. All

but a few of these carriers are thought to meet criteria of the Small

Business Administration as ``small business,'' e.g., motor freight

carriers with annual revenue less than $18.5 million.

Extending the date for compliance with the RPP requirements will

allow those carriers to continue to transport radioactive materials,

until October 1, 1999, without having to develop and implement a

written plan (or for those carriers transporting radioactive materials

under an exemption, a plan that goes beyond what is now required).

Based on the above, I certify that this rule will not have a

significant adverse economic impact on a substantial number of small

entities.

D. Unfunded Mandates Reform Act of 1995

This rule does not impose unfunded mandates under the Unfunded

Mandates Reform Act of 1995. It does not result in costs of $100

million or more, in the aggregate, to any of the following: State,

local, or Indian tribal governments, or the private sector. This rule

is the least burdensome alternative that achieves the objective of the

rule.

E. Paperwork Reduction Act

This rule does not impose any information collection burdens. RSPA

has concluded that the information collection approval under OMB

control number 2137-0510 (which expires January 31, 1998, unless

renewed) does not cover the information collection requirements in the

RPP requirements. Because Subpart I of 49 CFR Part 172 does not display

a valid OMB control number, no person is required to respond to its RPP

requirements.

If RSPA decides to retain the RPP requirements, in the form of

Subpart I of 49 CFR Part 172 or otherwise, RSPA will submit this

information collection and recordkeeping requirement to OMB for

approval. As part of that process, RSPA will provide interested members

of the public and affected agencies an opportunity to comment on

information collection and recordkeeping requests, as provided in OMB's

regulations.

F. Regulation Identifier Number (RIN)

A regulation identifier number (RIN) is assigned to each regulatory

action listed in the Unified Agenda of Federal Regulations. The

Regulatory Information Service Center publishes the Unified Agenda in

April and October of each year. The RIN contained in the heading of

this document can be used to cross-reference this action with the

Unified Agenda. The September 28, 1995 final rule and the May 8, 1996

final rule were published under RIN 2037-AB60.

List of Subjects in 49 CFR Part 172

Hazardous materials transportation, Hazardous waste, Labeling,

Packaging and containers, Reporting and recordkeeping requirements.

In consideration of the foregoing, the following provisions in 49

CFR part 172 is amended as follows:

PART 172--HAZARDOUS MATERIALS TABLE, SPECIAL PROVISIONS, HAZARDOUS

MATERIALS COMMUNICATIONS, EMERGENCY RESPONSE INFORMATION, AND

TRAINING REQUIREMENTS

1. The authority citation for part 172 continues to read as

follows:

Authority: 49 U.S.C. 5101-5127, 49 CFR 1.53.

2. Section 172.807 is revised to read as follows:

Sec. 172.807 Transitional provisions.

Compliance with the requirements of this subpart is required after

October 1, 1999.

Issued in Washington, DC on December 12, 1997, under authority

delegated in 49 CFR Part 1.

Kelley S. Coyner,

Acting Administrator.

[FR Doc. 97-33030 Filed 12-19-97; 8:45 am]

BILLING CODE 4910-60-P