Hazardous Materials: Withdrawal of Radiation Protection Program Requirement

SUMMARY: RSPA is removing regulations on ``Radiation Protection

Program'' and related modal provisions that require persons who offer,

accept for transportation, or transport radioactive materials to

develop and maintain a written radiation protection program. This

action is necessary to address difficulties and complexities concerning

implementation of and compliance with the requirements for a radiation

protection program, as evidenced by comments received from the

radioactive material transportation industry and other interested

parties.

DATE: Effective date: September 10, 1998.

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

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

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

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

20590-0001.

SUPPLEMENTARY INFORMATION:

I. Background

On September 28, 1995, RSPA published a final rule in the Federal

Register under Docket No. HM-169A (60 FR 50292). The changes made in

HM-169A were part of RSPA's ongoing effort to harmonize the Hazardous

Materials Regulations (HMR; 49 CFR parts 171-180) with international

standards and to improve radiation safety for workers and the public

during the transportation of radioactive materials.

One of the substantive regulatory changes under HM-169A was a

requirement to develop and maintain a written radiation protection

program (RPP). The RPP requirements are found in subpart I of part 172

of the HMR. Implementation provisions for rail, air, vessel and highway

are found in Secs. 174.705, 175.706, 176.703, and 177.827,

respectively. The RPP requirements apply, with certain exceptions, to

each person who offers for transportation, accepts for transportation,

or transports Class 7 (radioactive) materials. Compliance with the RPP

requirements was required after October 1, 1997.

Following publication of the September 28, 1995 final rule, many

comments were received concerning technical difficulties in

implementing the RPP requirements. Subsequently, on April 19, 1996,

RSPA published in the Federal Register a request for comments on the

implementation of 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.

RSPA received 23 comments in response to Notice 96-7. After

considering these comments, RSPA decided that the concerns expressed

could not all be resolved through guidance; new rulemaking was required

in order to adequately address many of the issues raised in the

comments. RSPA determined that the current RPP requirements in subpart

I of part 172, and Secs. 173.441, 174.705, 175.706, 176.703 and 177.827

should be withdrawn, because the RPP could not be corrected without

significant review and a further rulemaking action. Accordingly, RSPA

published a direct final rule on September 2, 1997 (62 FR 46214),

withdrawing the RPP requirements effective September 30, 1997, unless

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

received by September 30, 1997. Because RSPA received two adverse

comments the direct final rule was revoked in a separate rulemaking

action. As a result of the direct final rule revocation, on December

22, 1997 (62 FR 66898), RSPA published a notice of proposed rulemaking

(NPRM) (HM-169B; 62 FR 66903) proposing to amend the Hazardous

Materials Regulation by removing subpart I of 49 CFR part 172,

``Radiation Protection Program'' and related modal provisions that

require persons who offer, accept for transportation or transport

radioactive materials to develop and maintain a written radioactive

protection program.

In a final rule published under HM-169B (62 FR 66900), RSPA also

extended until October 1, 1999, the date for compliance with the RPP

requirements, because RSPA believed that requiring compliance with

requirements, which in the NPRM are being proposed to be withdrawn,

would be inappropriate.

II. Comments Received

A total of 14 comments were received in response to the December

22, 1997 NPRM. Commenters represented electric power utilities,

radiopharmaceutical manufacturers, and other offerors and carriers of

radioactive materials. Thirteen of the fourteen commenters agreed with

the proposal in the NPRM, citing modal differences as a factor which

makes application of the RPP requirements difficult. Examples given by

commenters include difficulties in tracking doses to railroad workers

and ship crews because rail cars are generally transferred between

carriers during transport, and because most ships are registered under

foreign flags and also operate in foreign ports. Several commenters

also stated that personnel involved in bulk or containerized transport

of radioactive material by highway, rail, or vessel usually receive

much lower doses of radioactivity than workers that handle non-bulk

shipments.

Additional comments pointed to ambiguities in the RPP requirements.

These commenters stated that the regulations do not make clear whether

the 200 transport index (TI) threshold to qualify for an exception is

to be applied over an entire company or at each site; that concepts

such as ``approved by a Federal or state agency'' and ``occupationally

exposed hazmat worker'' are vague; and that the requirement to monitor

occupationally exposed hazmat workers appears to be too inclusive and

may be interpreted to cover workers whose doses would be expected to be

below the limit of detection of the dosimeters. Most commenters noted

the difficulty of being able to assure compliance with the requirements

cited in the regulations for dose and dose rate limits for members of

the general public.

Several commenters cited inconsistencies with other regulations.

For example, in contrast to the HMR, the Nuclear Regulatory Commission

(NRC) regulations and Environmental Protection Agency guidelines do not

include a quarterly occupational dose limit, or a weekly dose or a dose

rate limit for members of the public; the HMR criteria for determining

whether monitoring is required differ appreciably from those in the

International Atomic Energy Agency (IAEA) regulations; the HMR annual

limit for members of the public is different from that of the NRC and

the IAEA regulations; the HMR recordkeeping requirements are different

from the NRC's; and the HMR require monitoring of occupationally

[[Page 48567]]

exposed hazmat workers, while the NRC requires monitoring adult workers

with personal dosimetry only if their annual dose is likely to exceed 5

millisieverts.

One commenter additionally noted that entities with an RPP are

required to comply with the stated dose limits for members of the

general public, while entities which qualify for an exception are not.

Commenters also stated that implementation of the RPP requirements

would force affected shippers and carriers to adopt the most

conservative approach, leading to unnecessarily high costs and

potentially causing some carriers to no longer carry radioactive

materials.

One commenter stated that RSPA should not remove the RPP

requirements from the HMR. The commenter stated that all shippers and

consignees of radioactive materials already have formal, approved,

written procedures for the handling of radioactive material and

exposure monitoring for their personnel and as a result, all shippers

and consignees already meet the RPP requirements. The commenter did not

provide information on how those current formal, written procedures

align with the provisions of the HMR's RPP requirements for shippers

and how they could be implemented by carriers. For example, no

information was provided on how a shipper or carrier could determine or

measure exposure to the general public, which has been stated by other

commenters to be a significant problem with the current RPP

requirements. The commenter also stated that any such difficulties and

complexities with the HMR's RPP can and should be dealt with in a

combination of: (a) Amending the RPP; (b) issuing more detailed

guidelines or other means; and (c) flexible cooperative enforcement.

The commenter did not support this position by providing specific

recommendations relative to revisions to the current RPP, the type of

guidelines that could be developed, and did not explain what was meant

by ``flexible and cooperative enforcement.''

RSPA agrees with commenters that the current RPP program is not

clear in its application and is not fully compatible with other

regulations, such as those issued by the EPA and NRC. RSPA further

believes that certain aspects of the current RPP requirements are not

able to be practically implemented, such as those addressing public

exposure.

RSPA does believe that hazmat workers and the public should be

protected from exposure to radiation. RSPA reminds hazmat employers

that the training requirements in subpart H of part 172, require that

each hazmat employer train each of its hazmat employees prior to

performing any hazmat function under the HMR. Such training must

provide a general awareness of the requirements of the HMR, including

meanings of package markings and labels. A hazmat employee must receive

function specific training applicable to their performance of specific

regulatory requirements under the HMR. For example a hazmat employee

that handles and transports packages of radioactive materials should

receive specific training that includes: properly determining the

Transport Index (TI) of a radioactive material package; determining the

maximum TI allowed on a transport vehicle; and procedures that address

the storage, segregation, and separation requirements for radioactive

materials packages. Additionally, a hazmat employee must receive safety

training that provides information regarding the hazards presented by

radioactive materials, use of appropriate safety and monitoring

equipment, and how to protect themselves from unnecessary exposure to

radioactive materials (e.g., ``Do not sit on a package containing

radioactive materials.''). The intent of the radioactive materials

requirements of the HMR is to minimize radiation hazards to workers and

the public. These provisions include: limits on the amount of

radioactive materials that may be transported in a package; shielding

requirements for packagings to limit surface radiation; specific

testing of Type A packagings to ensure that they can survive conditions

normally incident to transportation; testing of Type B packages for

radioactive materials for both normal and accident conditions during

transportation; hazard communication, including shipping paper

information, labels, and markings to provide identification of the

hazards of the material being transported; package surface

contamination limits; and requirements addressing the segregation and

separation of packages from passengers and hazmat employees. RSPA also

notes that many radioactive material shippers, specifically Department

of Energy contractors or NRC or Agreement State licensees, are already

subject to RPP requirements, though not identical with the HMR's RPP.

In addition, several carriers who transport radioactive materials under

exemptions issued by RSPA are required to have an RPP in place which

includes use of a qualified health physicist to monitor employee

exposure. RSPA believes that the requirements in the HMR and the other

agencies RPP's ensure an acceptable level of safety for both hazmat

employees and the public.

RSPA will continue to review and evaluate criteria for developing

RPP's, such as the Recommendations Approved by the President entitled

``Radiation Protection Guidance to Federal Agencies for Occupational

Exposure,'' and criteria adopted by the IAEA Safety Standards Series

No. ST-1. RSPA may propose a revised RPP as a means of incrementally

improving safety for hazmat workers and the public in the future.

Based on the foregoing discussion and as proposed, RSPA is removing

subpart I of 49 CFR part 172, ``Radiation Protection Program'' and

related modal provisions that require persons who offer, accept for

transportation or transport radioactive materials to develop and

maintain a written radioactive protection program.

Regulatory Analyses and Notices

A. Executive Order 12866 and DOT Regulatory Policies and Procedures

This final rule provides relief to persons who offer for

transportation, accept for transportation, or transport Class 7

(radioactive) materials by eliminating the need to develop and maintain

a radiation protection program. This rule is not considered a

significant regulatory action under section 3(f) of Executive Order

12866 and 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 prepared a regulatory evaluation in support of the final

rule that specifically addresses the issue of withdrawing requirements

for a radiation protection program.

RSPA concludes that the benefits of removing the radiation

protection program requirement are, at a minimum, the $6.6 million per

year that the RPP requirements would cost to implement, as estimated by

RSPA in the regulatory evaluation prepared in support of the final rule

issued under Docket No. HM-169A. At that time, RSPA did not have

sufficient data to quantitatively assess benefits to be derived from

the radiation protection program requirements. However, the regulatory

evaluation considered the health benefits to the transportation

community of limiting radiation exposures to be significant.

RSPA now considers that the RPP requirements are so overly

restrictive, ambiguous, and inconsistent with the requirements of other

Federal agencies

[[Page 48568]]

that they would tend to cause affected parties to adopt the most

conservative approach, leading to greater costs than previously

estimated. Therefore, RSPA concludes that the costs of implementation

of RPP requirements will exceed their benefits and that withdrawing the

requirements is cost-effective.

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, (49 U.S.C. 5101-5127)

contains express preemption provisions at 49 U.S.C. 5125.

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

that would be preempted by a withdrawal of the RPP requirements. This

final rule does not have sufficient federalism impacts to warrant the

preparation of a federalism assessment.

C. Executive Order 13084

This rule has been analyzed in accordance with the principles and

criteria contained in Executive Order 13084 (``Consultation and

Coordination with Indian Tribal Governments''). Because this rule would

not significantly or uniquely affect the communities of the Indian

tribal governments, the funding and consultation requirements of this

Executive Order do not apply.

D. Regulatory Flexibility Act

The Regulatory Flexibility Act (Act), as amended, 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 requirements for a radiation protection

program, RSPA estimated a total of 497 carriers (primarily motor

carriers) would be subject to those requirements. All but a certain few

of those carriers are thought to meet criteria of the Small Business

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

annual revenue of less than $18.5 million. The effect of withdrawing

requirements for a radiation protection program is to allow those

carriers to continue to transport radioactive materials without having

to develop and implement a written plan that goes beyond what is now

required of them by the HMR, by a RSPA exemption, or by other Federal

departments and agencies.

Based upon the above, I certify that this final rule will not have

a significant economic impact on a substantial number of small

entities.

E. Unfunded Mandates Reform Act of 1995

This final 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 to either State, local, or tribal governments, in

the aggregate, or to the private sector, and is the least burdensome

alternative that achieves the objective of the rule.

F. Paperwork Reduction Act

There are no information collection requirements in this final

rule.

G. 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 number contained in the heading

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

Unified Agenda.

List of Subjects

49 CFR Part 172

Hazardous materials transportation, Hazardous waste, Labeling,

Packaging and containers, Reporting and recordkeeping requirements.

49 CFR Part 173

Hazardous materials transportation, Packaging and containers,

Radioactive materials, Reporting and recordkeeping requirements,

Uranium.

49 CFR Part 174

Hazardous materials transportation, Radioactive materials, Railroad

safety.

49 CFR Part 175

Air carriers, Hazardous materials transportation, Radioactive

materials, Reporting and recordkeeping requirements.

49 CFR Part 176

Hazardous materials transportation, Maritime carriers, Radioactive

materials, Reporting and recordkeeping requirements.

49 CFR Part 177

Hazardous materials transportation, Motor carriers, Radioactive

materials, Reporting and recordkeeping requirements.

In consideration of the foregoing, 49 CFR parts 172, 173, 174, 175,

176, and 177 are 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.

Secs. 172.801--172.807 (Subpart I) [Removed]

2. In part 172, subpart I consisting of Secs. 172.801 through

172.807, is removed.

PART 173--SHIPPERS--GENERAL REQUIREMENTS FOR SHIPMENTS AND

PACKAGINGS

3. The authority citation for part 173 continues to read as

follows:

Authority: 49 U.S.C. 5101-5127, 49 CFR 1.45 and 1.53.

4. In Sec. 173.441, paragraph (b)(4) is revised to read as follows:

Sec. 173.441 Radiation level limitations.

* * * * *

(b) * * *

(4) 0.02 mSv/h (2mrem/h) in any normally occupied space, except

that this provision does not apply to carriers if they operate under

the provisions of a State or federally regulated radiation protection

program and if personnel under their control who are in such an

occupied space wear radiation dosimetry devices.

* * * * *

PART 174--CARRIAGE BY RAIL

5. The authority citation for part 174 continues to read as

follows:

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

Sec. 174.705 [Removed]

6. Section 174.705 is removed.

PART 175--CARRIAGE BY AIRCRAFT

7. The authority citation for part 175 continues to read as

follows:

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

Sec. 175.706 [Removed]

8. Section 175.706 is removed.

PART 176--CARRIAGE BY VESSEL

9. The authority citation for part 176 continues to read as

follows:

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

Sec. 176.703 [Removed]

10. Section 176.703 is removed.

[[Page 48569]]

PART 177--CARRIAGE BY PUBLIC HIGHWAY

11. The authority citation for part 177 continues to read as

follows:

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

Sec. 177.827 [Removed]

12. Section 177.827 is removed.

Issued in Washington, DC on September 4, 1998, under authority

delegated in 49 CFR part 1.

Stephen D. Van Beek,

Deputy Administrator.

[FR Doc. 98-24343 Filed 9-9-98; 8:45 am]

BILLING CODE 4910-60-P