[Federal Register Volume 62, Number 169 (Tuesday, September 2, 1997)]
[Rules and Regulations]
[Pages 46214-46217]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-23083]
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DEPARTMENT OF TRANSPORTATION
Research and Special Programs Administration
49 CFR Parts 172, 174, 175, 176 and 177
[Docket No. RSPA-97-2850 (HM-169B)]
RIN 2137-AD08
Hazardous Materials: Withdrawal of Radiation Protection Program
Requirement
AGENCY: Research and Special Programs Administration (RSPA), DOT.
ACTION: Direct final rule.
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SUMMARY: RSPA is removing Radiation Protection Program regulations and
related modal provisions that require the development and maintenance
of a written radiation protection program for persons who offer, accept
for transportation, or transport radioactive materials. 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: This final rule is effective September 30, 1997, unless an
adverse comment or notice of intent to file an adverse comment is
received by September 30, 1997. RSPA will publish in the Federal
Register a document confirming the effective date of this direct final
rule.
ADDRESSES: Address comments to the Dockets Unit (DHM-30), Research and
Special Programs Administration, U.S. Department of Transportation,
Washington, DC 20590-0001. Comments should identify the Docket (HM-
169B) and be submitted in five copies. Persons wishing to receive
confirmation of receipt of their comments should include a self-
addressed stamped postcard showing the docket number. The Docket Unit
is located in Room 8421 of the Nassif Building, 400 Seventh Street,
SW., Washington, DC 20590-0001. Public dockets may be viewed between
the hours of 8:30 a.m. and 5 p.m., Monday through Friday, except
Federal holidays. Comments may also be submitted by E-mail to
rules@rspa.dot.gov.'' 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 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 operations involving the transportation of
radioactive materials.
One of the substantive rules in Docket HM-169A was a requirement to
establish a written radiation protection program (RPP). The RPP
requirements are found in subpart I of 49 CFR part 172. The RPP
implementation provisions for rail, air, vessel and highway are found
in Secs. 174.705, 175.706, 176.703, and 177.827, respectively. The RPP
requirement applies, with certain exceptions, to each person who offers
for transportation, accepts for transportation, or transports Class 7
(radioactive) materials. The effective date of the RPP requirement is
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.
Several commenters cited modal differences as a factor which makes
application of the RPP regulations 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 that
make honest efforts to develop RPP plans uncertain as to their
adequacy. 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
[[Page 46215]]
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 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 five
petitions, three of which were characterized as petitions for
reconsideration, but which are considered as petitions for rulemaking
because they were received after the thirty day period in 49 CFR
106.35. A discussion of the petitions follows.
Two different parts of 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 requirement be postponed, and that an
exception to the RPP requirement be allowed for less-than-truckload
(LTL) non-exclusive use shipments of radioactive material.
The Radiopharmaceutical Shippers and Carriers Conference requested
amendments to various paragraphs of the RPP requirement. 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 Nuclear Energy Institute petitioned RSPA to rescind the public
radiation measurement requirement in 49 CFR 172.803(b)(2).
RSPA agrees that several of the comments discussed above have
merit, and has attempted to resolve those concerns by formulation of a
guidance document. However, RSPA has decided that not all of the
concerns can be resolved through guidance, and new rulemaking is
required in order to adequately address these and other comments.
Because the necessary rulemaking actions cannot be taken before the
October 1, 1997 effective date of the RPP requirements, RSPA has
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.
The disposition of the five petitions for rulemaking will be decided at
a later date. However, the arguments presented have been considered
along with the other comments received.
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 a RPP requirement. RSPA also
continues to believe that some form of RPP requirement should be
established in the HMR, to provide a formal and structured framework
for ensuring radiation safety during radioactive material
transportation activities.
Until the September 28, 1995 final rule under Docket HM-169A, the
HMR had not generally required hazmat employers involved in the
transport of radioactive materials to specifically consider the
radiation safety of their workers and to take steps to improve that
safety, if necessary. Rather, the HMR have sought to minimize radiation
hazards to workers and the public by including requirements on: (1)
Packagings designed and tested to contain radioactive materials under
normal conditions of transportation and under accident conditions; (2)
hazard communication requirements, 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.
Accordingly, 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 a revised RPP requirement. RSPA may propose in a
future rulemaking the establishment of a revised RPP requirement, to
provide such a formal and structured framework.
This direct final rule is issued under the procedures set forth in
49 CFR 106.39. Because this direct final rule removes regulatory
requirements that otherwise would be effective on October 1, 1997, this
direct final rule is effective September 30, 1997, without the
customary 30-day delay following publication and unless RSPA receives
an adverse comment by September 30, 1997. Interested parties should
refer to Sec. 106.39(c) for a discussion of what constitutes an adverse
comment.
Regulatory Analyses and Notices
A. Executive Order 12866 and DOT Regulatory Policies and Procedures
This final 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). This
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.
RSPA did not prepare a regulatory evaluation that specifically
addressed the issue of withdrawing requirements for a radiation
protection program. However, the regulatory evaluation proposed in
support of the final rule issued under Docket HM-169A (60 FR 50292;
September 28, 1995) estimated annual costs attributed to radiation
protection program requirements in the amount of $6.6 million. RSPA did
not have sufficient data to quantify estimated benefits derived from
the radiation protection program requirements.
Comments submitted in response to RSPA's effort to develop
regulatory guidance for development, implementation, and maintenance of
an effective radiation protection program conforming to requirements in
49 CFR part 172, subpart I, lead RSPA to conclude that it cannot
provide
[[Page 46216]]
appropriate guidance, based on the final rule published under Docket
No. HM-169A, that meets the needs for safety in transportation through
procedures that are consistent with other Federal regulations and at
costs that are not unnecessarily high. That being the case, RSPA
cannot, at this time, justify the need for persons who offer for
transportation, accept for transportation, or transport radioactive
materials to develop, implement, and maintain a written radiation
protection plan.
B. Executive Order 12612
This final 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 an express preemption provision that preempts State, local and
Indian tribe requirements on certain covered subjects. Covered subjects
are:
(i) The designation, description, and classification of hazardous
materials;
(ii) The packing, repacking, handling, labeling, marking, and
placarding of hazardous materials;
(iii) The preparation, execution, and use of shipping documents
pertaining to hazardous materials and requirements related to the
number, contents, and placement of those documents;
(iv) The written notification, recording, and reporting of the
unintentional release in transportation of hazardous materials; and
(v) The design, manufacturing, fabricating, marking, maintenance,
reconditioning, repairing, or testing of a packaging or a container
which is represented, marked, certified or sold as qualified for use in
the transportation of hazardous material.
This final rule does not have sufficient federalism impacts to
warrant the preparation of a federalism assessment.
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 many of those carriers through RSPA's exemption program, or
that of 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.
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 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
This final rule does not impose any information collection burdens.
Information collection requirements addressing radioactive materials
requirements are currently approved under OMB approval number 2137-
0510. This approval expires January 31, 1998. RSPA plans to submit a
revised information collection to OMB for renewal prior to the
expiration date. Under the Paperwork Reduction Act of 1995, no person
is required to respond to an information collection unless it displays
a valid OMB control number.
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 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.
Subpart I--[Removed]
2. In part 172, subpart I is removed.
PART 174--CARRIAGE BY RAIL
3. 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]
4. Section 174.705 is removed.
PART 175--CARRIAGE BY AIRCRAFT
5. 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]
6. Section 175.706 is removed.
PART 176--CARRIAGE BY VESSEL
7. 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]
8. Section 176.703 is removed.
PART 177--CARRIAGE BY PUBLIC HIGHWAY
9. 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]
10. Section 177.827 is removed.
[[Page 46217]]
Issued in Washington, DC, on August 22, 1997, under authority
delegated in 49 CFR Part 1.
Kelley S. Coyner,
Acting Administrator.
[FR Doc. 97-23083 Filed 8-29-97; 8:45 am]
BILLING CODE 4910-60-P
