Hazardous Materials: Withdrawal of Radiation Protection Program Requirement

Federal RegisterDec 22, 1997

Ask Donna

What actually matters in this document.

Text

SUMMARY: RSPA is proposing to amend the Hazardous Materials Regulations

(HMR) to remove 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 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.

DATES: Comments must be received on or before February 13, 1998.

ADDRESSES: Address comments to the Dockets Management System, U.S.

Department of Transportation, 400 Seventh Street, SW, Washington, D.C.

20590-0001. Comments should identify the Docket No. [RSPA-97-2850 (HM-

169B)] and be submitted in two copies. Persons wishing to receive

confirmation of receipt of their comments should include a self-

addressed stamped postcard. The Dockets Management System is located on

the Plaza level of the Nassif Building at the above address. Public

dockets may be reviewed between the hours of 10:00 a.m. and 5:00 p.m.,

Monday through Friday, except Federal holidays. Comments may also be

submitted by E-mail to ``[email protected].'' In every case, the

comment should refer to the Docket Number set forth above.

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: 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 Docket No. HM-169A were part of RSPA's

ongoing effort to harmonize the Hazardous Materials Regulations (HMR;

49 CFR 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 Docket No. HM-169A

is 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. 174.705, 175.706, 176.703, and 177.827 should

be withdrawn, because it did not believe they could 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 it is revoking the direct final rule in a separate

document. In a final rule published in Docket No. HM-169B, RSPA is also

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

requirements, because it does not believe it would be appropriate to

require compliance with requirements which it is proposing to withdraw

in this NPRM.

Several commenters to Notice 96-7 cited modal differences as a

factor which makes application of the RPP requirements difficult.

Examples given include difficulties in tracking doses to workers

involved in shipping radioactive material by rail because of multiple

transfers from one company to another of rail cars during transport, or

to ship crews because of ships being registered under foreign flags, or

because often their operations are carried out in foreign ports.

Several commenters stated that dose to personnel involved in bulk or

containerized transport of radioactive material by highway, rail, or

vessel is usually much lower than for non-bulk shipments.

Additional comments pointed to ambiguities in the regulations. Some

of the ambiguities cited are 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 extend even to those workers

whose doses would be expected to be below the limit of detection of the

dosimeters. Most commenters noted the practical impossibility 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, and the uncertainty as to which persons are included in the

category of ``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 (EPA) 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

[[Page 66904]]

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

occupationally exposed hazmat workers, while the NRC requires

monitoring adult workers with personal dosimetry only if their annual

dose is likely to exceed 5 mSv.

Commenters stated that there are also internal inconsistencies in

the present RPP requirements. For example, one commenter noted that

entities with an RPP are required to comply with the stated limits for

dose to members of the general public, while entities which qualify for

an exception are not. Another commenter indicated that the monthly

limit of 0.5 mSv for a declared pregnant worker renders irrelevant the

additional stated limit of 5 mSv during the term of pregnancy.

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 serious disruption of the market.

In addition to the comments received, RSPA also received six

petitions. The first was a petition for reconsideration received from

the Radiopharmaceutical Shippers and Carriers Conference (RSCC) in

response to publication of Docket No. HM-169A as a final rule. This

petition was considered and denied in a May 8, 1996 Federal Register

notice (61 FR 20748). Three documents purporting to be ``petitions for

reconsideration'' of the September 28, 1995 final rule received during

the comment period established in Notice 96-7, were treated as comments

rather than petitions for reconsideration because they were received

after the thirty day period in the September 28, 1995 final rule.

Petitions for rulemaking were received from the RSCC and the Nuclear

Energy Institute (NEI). A discussion of these remaining five petitions

follows.

Lockheed Martin (Energy Research Corporation and Energy Systems,

Inc.), Los Alamos National Laboratories, and the Oak Ridge Operations

Office of the Department of Energy requested that implementation of the

RPP requirements be postponed, and that an exception to the RPP

requirements be allowed for less-than-truckload (LTL) non-exclusive use

shipments of radioactive material.

RSCC requested amendments to various paragraphs of the RPP

requirements. These included restricting the 0.02 mSv/hour (2 mrem/

hour) limit to members of the public and other non-occupationally

exposed individuals to those radioactive material transportation

activities which occur at fixed facilities; changing the threshold to

qualify for an exception from 200 TI to 1000 TI; and applying the 1000

TI threshold exception for each fixed facility. It was requested, also,

that regulations be clarified by specifically stating that

certification by the American Board of Health Physics is not the only

acceptable criterion as evidence of competency of the evaluator

referred to in 49 CFR 172.803(d)(ii). Finally, it was requested that

the wording ``200 TI'' be changed to ``1000 TI'' and ``worker'' changed

to ``occupationally exposed hazmat employee'' in 49 CFR 172.805(d); and

that the effective date of October 1, 1997 be postponed until

appropriate guidance is available.

The NEI petitioned RSPA to rescind the public radiation measurement

requirement in 49 CFR 172.803(b)(2).

The arguments presented in these petitions have been considered

along with the other comments received. However, the disposition of the

petitions for rulemaking will be decided at a later date.

Two persons submitted adverse comments on the direct final rule:

Caliber System, Inc. and Davis Transport Inc. Caliber System, Inc.,

believes that the concerns raised through public comments can be

addressed through guidance and other means. It contends 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 are already in compliance with HM-169A. In

addition, it argues that carriers who regularly engage in transporting

radioactive materials in the course of their main business also have

formal, written and approved programs. Davis Transport, Inc., argues

that RSPA did not adequately consider worker safety, overemphasized the

comments on economic ability to comply, and overstated the

inconsistency and compliance assurance issues associated with the rule.

Before the September 28, 1995 final rule under Docket No. HM-169A,

the HMR had not contained a performance standard requiring hazmat

employers to minimize radiation exposure to the lowest level possible

through a RPP. In the past, the HMR have sought to minimize radiation

hazards to workers and the public by including requirements on: (1)

packagings designed and tested to contain Type A quantities of RAM

under normal conditions, and Type B quantities of radioactive materials

under both normal and accident conditions during transportation; (2)

hazard communication, such as shipping paper information, labels, and

markings; (3) limitations on permissible rates of external radiation

and package contamination; and (4) segregation and separation of

packages from passengers and hazmat employees. This system has worked

well, but it can be improved.

RSPA believes that some form of an RPP requirement may be

appropriate in the HMR, to provide a formal and structured framework

for ensuring radiation safety during radioactive material

transportation activities. RSPA notes that many shippers of radioactive

material, specifically those who are Department of Energy contractors

or NRC or Agreement State licensees, are already subject to RPP

requirements. RSPA will continue to review criteria, such as those

adopted by the IAEA Safety Series Standards Series No. ST-1, that could

form the basis of revised RPP requirements in the HMR. As a result,

RSPA may propose in a future rulemaking the establishment of revised

RPP requirements, to provide such a formal and structured framework.

Regulatory Analyses and Notices

A. Executive Order 12866 and DOT Regulatory Policies and Procedures

This proposed 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. The effect of this rule, as proposed,

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 proposed 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 that specifically

addresses the issue of withdrawing requirements for a radiation

protection program. The regulatory evaluation prepared in support of

the final rule issued under Docket No. HM-169A (60 FR 50292; September

28, 1995) estimated annual costs attributed to radiation protection

program requirements in the amount of $6.6 million. 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.

[[Page 66905]]

The benefits of removing the radiation protection program are, at a

minimum, the $6.6 million RSPA estimated that the RPP requirements

would cost to implement. However, RSPA believes that the RPP

requirements are so overly restrictive, ambiguous, and inconsistent

with the requirements of other Federal agencies that they would tend to

cause affected parties to adopt the most conservative approach, leading

to unnecessarily high costs in order to assure compliance. Therefore,

RSPA believes that the health benefits in implementing these

requirements would be much lower than originally anticipated. Also,

because of the problems with the RPP requirements which have been

identified, RSPA believes that any improvements to safety through

implementation of the current RPP requirements would be much less than

anticipated and their value would be less than the costs of

implementation. Therefore, RSPA believe 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 proposed 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 premempt

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

(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;

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 requirements

that would be preempted by a withdrawal of the RPP requirements, as

proposed herein. RSPA invites comments on this subject and, if any

person believes that this proposed rule concerns a covered subject,

what the effective date of Federal preemption should be.

C. 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 proposed rule will not

have a significant adverse economic impact on a substantial number of

small entities.

D. Unfunded Mandates Reform Act of 1995

This proposed 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.

E. Paperwork Reduction Act

Under regulations implementing the Paperwork Reduction Act of 1995,

``* * * an agency may not conduct or sponsor, and a person is not

required to respond to, a collection of information unless it displays

a currently valid OMB control number.'' 5 CFR 1320.8(b)(iii)(6). RSPA

has reviewed the HM-169A final rule and the information collection

approval for radioactive materials transportation requirements. (OMB

control number 2137-0510 was issued in January 1995 in anticipation of

the final rule to be issued under Docket No. HM-169A. That approval

expires on January 31, 1998, unless renewed.) Based on that review,

RSPA concludes that the OMB approval is limited to information

collection requirements for radioactive materials transportation other

than the RPP requirements contained in Subpart I of Part 172.

Section 1320.8(d), Title 5, Code of Federal Regulations requires

that RSPA provide interested members of the public and affected

agencies an opportunity to comment on information collection and

recordkeeping requests. RSPA estimates that the total information

collection and recordkeeping burden for a Radiation Protection Program

is:

Number of Respondents: 497.

Total Annual Responses: 497.

Total Annual Burden Hours: 94,286.

Total Annual Burden Cost: $6.6 million.

These figures are based on RSPA's estimates from the regulatory

evaluation under HM-169A. As previously indicated, the estimate of

total annual burden cost may be higher than this estimate. However,

RSPA estimates that approximately 497 (50%) of these carriers will be

required to implement and maintain a full radiation protection program.

The cost of a radiation protection program was considered in two parts.

First, RSPA considered the cost of monitoring those workers who are not

currently required to be monitored by the existing regulations of the

Occupational Safety and Health Administration or the Nuclear Regulatory

Commission. The second cost considered was that of the hourly wages of

technical and managerial workers to implement the radiation protection

program. Other costs of a radiation protection program are already

accounted for in the requirements of the HMR for a HAZMAT employer to

give their HAZMAT employees safety training relative to the risks

associated with the material a person transports.

[[Page 66906]]

Requests for a copy of this information collection should be

directed to Deborah Boothe, Office of Hazardous Materials Standards

(DHM-10), Research and Special Programs Administration, Room 8102, 400

Seventh Street, SW, Washington, DC 20590-0001. Telephone (202) 366-

8553.

RSPA specifically requests comments on the information collection

and recordkeeping burdens associated with developing, implementing and

maintaining a radiation protection program. Written comments should be

addressed to the Dockets Unit as identified in the ADDRESSES section of

this rulemaking. Comments should be received prior to the close of

comment period identified in the DATES section of this rulemaking. If a

decision is made to retain the RPP requirements, RSPA will submit this

information collection and recordkeeping requirement to the Office of

Management and Budget for approval.

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 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 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, 174, 175, 176,

and 177 is proposed to be 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 would continue to read as

follows: