[Federal Register Volume 59, Number 183 (Thursday, September 22, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-23566]


[[Page Unknown]]

[Federal Register: September 22, 1994]


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Part XI





Department of Transportation





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Research and Special Programs Administration



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49 CFR Part 171




Infectious Substances; Extension of Compliance Dates; Final Rule
DEPARTMENT OF TRANSPORTATION

Research and Special Programs Administration

49 CFR Part 171

[Docket No. HM-181G; Amendment No. 171-128]
RIN 2137-AC36

 
Infectious Substances; Extension of Compliance Dates

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

ACTION: Final rule; extension of compliance dates.

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SUMMARY: RSPA is extending the compliance dates for classification, 
hazard communication, and packaging requirements of the Hazardous 
Materials Regulations applicable to infectious substances, including 
regulated medical waste. The extension is intended to provide RSPA with 
time to evaluate the need for changes to regulatory requirements which 
had been scheduled to go into effect on October 1, 1994, and to 
continue coordination with other Federal agencies that have 
jurisdiction over infectious substances. The extension is responsive to 
the concerns of shippers and transporters that more interagency 
coordination is needed in order to avoid overlapping or inconsistent 
Federal requirements for infectious substances.

DATES: This amendment is effective on September 22, 1994. However, if 
RSPA receives comments by September 30, 1994, that illustrate that an 
extension of compliance dates is not in the public interest, RSPA will 
remove this final rule amendment and propose another date.

ADDRESSES: Address comments to the Dockets Unit (DHM-30), Research and 
Special Programs Administration, U.S. Department of Transportation, 400 
Seventh Street, SW, Washington, DC 20590-0001. Comments should identify 
the docket number HM-181G) and amendment number (171-128) and be 
submitted, when possible, in five copies. Persons wishing to receive 
confirmation of receipt of their comments should include a self-
addressed stamped postcard. The Dockets Unit is located in Room 8421 of 
the Nassif Building, 400 Seventh Street SW, Washington, DC. Office 
hours are 8:30 a.m. to 5 p.m., Monday through Friday, except for public 
holidays.

FOR FURTHER INFORMATION CONTACT: Ms. Eileen Martin or Ms. Jennifer 
Antonielli, Office of Hazardous Materials Standards, Research and 
Special Programs Administration, 400 Seventh St., SW., Washington, DC 
20590-0001, telephone: (202) 366-8553.

SUPPLEMENTARY INFORMATION: On December 21, 1990, RSPA issued a final 
rule under Docket HM-181 (55 FR 52402) that comprehensively revised the 
Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) with 
respect to classification, hazard communication, and packaging 
requirements of hazardous materials. In Docket HM-181, RSPA adopted 
standards based on United Nations (UN) recommendations, including 
replacing the term ``etiologic agent'' with the term ``infectious 
substance'' and expanding the definition to include additional agents 
having the potential to cause severe, disabling, or fatal disease. On 
January 3, 1991, RSPA issued a final rule under Docket HM-142A (56 FR 
197), removing the previous exception from regulation for cultures and 
stocks of etiologic agents (infectious substances) of 50 milliliters or 
less total quantity in one outside package (the ``50 milliliter 
exception'').
    On December 20, 1991, in response to a large number of petitions 
for reconsideration, RSPA published a final rule making editorial and 
substantive revisions to the December 1990 final rule (56 FR 66124). In 
response to one petition for reconsideration, RSPA identified a 
subcategory of Division 6.2 (infectious substances) materials described 
as ``regulated medical waste'' (RMW), and provided packaging 
requirements for RMW which were less rigorous than those for other 
infectious substances. Following issuance of the December 1991 rule, 
RSPA received additional petitions for reconsideration and numerous 
comments and requests for clarification concerning provisions 
applicable to infectious substances and RMW. Petitioners were concerned 
that RSPA had not adequately considered the costs and other 
ramifications of adopting requirements for RMW. Commenters were 
concerned over potential overlaps or inconsistencies with other Federal 
agencies that regulate infectious substances. In partial response to 
the petitions, RSPA extended the compliance date for infectious 
substances from October 1, 1992, to April 1, 1993 (October 1, 1992; 57 
FR 45442). This extension and others which followed (March 3, 1993; 58 
FR 12182 and December 20, 1993; 58 FR 66302) also applied to the 50 
milliliter exception which was removed under Docket HM-142A.
    On March 3, 1993, RSPA issued an advance notice of proposed 
rulemaking (ANPRM) and announced a public hearing under Docket HM-181G 
(58 FR 12207) concerning the need for additional regulatory changes 
pertaining to infectious substances. In order to provide time to 
evaluate the oral and written comments received in response to the 
ANPRM, RSPA also extended the compliance date (58 FR 12182) for 
provisions applicable to infectious substances from April 1, 1993, to 
January 1, 1994. The ANPRM addressed a number of complex issues, 
pertaining to scope of regulation, consistency with regulations of 
other agencies, the need for revised standards for non-bulk and bulk 
packagings, and defining criteria for infectious substances and RMW. 
Following issuance of the ANPRM, RSPA continued its efforts to gain 
information on other Federal agencies' regulatory requirements, and 
hosted and participated in a number of interagency meetings on this 
issue. Federal agencies that regulate infectious substances include the 
Occupational Safety and Health Administration of the Department of 
Labor, the Centers for Disease Control (CDC) and the Food and Drug 
Administration of the Department of Health and Human Services, the 
United States Postal Service and the Animal and Plant Health Inspection 
Service of the Department of Agriculture. On December 20, 1993 (58 FR 
66302), RSPA again extended the compliance date for provisions 
applicable to infectious substances from January 1, 1994, to October 1, 
1994, to provide additional time for resolving the issues of concern.
    RSPA intends to issue a notice of proposed rulemaking (NPRM) in the 
near future. The NPRM will address those issues concerning infectious 
substances and RMW that must be addressed in the near term to ensure 
the safe transportation of these materials. The NPRM also will outline 
RSPA's intent to make a longer-term effort to harmonize requirements of 
the HMR with international regulations and with the regulations of the 
other Federal agencies, and identify and address gaps in regulation 
that may adversely impact transportation safety.
    Based on the merits of comments and petitions, RSPA believes there 
may be undue adverse impacts if regulatory provisions for infectious 
substances go into effect on October 1, 1994 without change. Therefore, 
in this document, RSPA is revising 49 CFR 171.14(b) to extend the 
compliance dates. For regulatory requirements for RMW and for materials 
infectious to animals only, the compliance date is extended from 
October 1, 1994, to October 1, 1995. This time period should be 
adequate for RSPA to publish the NPRM, evaluate comments received in 
response to the NPRM, and make any necessary changes to the HMR based 
on the merits of those comments. Without an extension of this 
compliance date, shippers and transporters of these materials would 
have to comply with regulations that are likely to be changed in the 
near future and, thereby, incur unnecessary costs.
    For other infectious substances, i.e., for cultures and stocks of 
substances infectious to humans, the compliance date is extended from 
October 1, 1994, to January 1, 1995. The requirements for these 
materials generally were not at issue in comments or petitions to the 
December 1991 final rule. The principal impacts of the January 1, 1995 
compliance date will be a nomenclature change from the old ``etiologic 
agent'' hazard class to the new ``Division 6.2'' classification, 
elimination of the 50 milliliter exception for cultures and stocks, and 
expansion of the definition of infectious substances to cover 
substances, such as the human immunodeficiency virus (HIV) and Lyme 
disease, which are not listed in the CDC regulations (42 CFR 72.3). The 
removal of the 50 milliliter exception and expansion of the definition 
of infectious substances originally were to have occurred on February 
19, 1991 (Docket HM-142A; January 3, 1991; 56 FR 197). RSPA believes it 
is necessary to implement these requirements as quickly as possible to 
ensure public safety and end confusion as to the status of materials 
that were not regulated prior to 1990.
    During the transition periods provided in Sec. 171.14, a person may 
comply with either the applicable ``old'' requirements of the HMR 
(i.e., those which were in effect on September 30, 1991), or the 
current requirements adopted under HM-181. If a material is an 
etiologic agent under the old regulations and does not meet any of the 
old exceptions, it must conform to either the old requirements (i.e., 
must be described, labeled and packaged as an ``etiologic agent'') or 
the current requirements of the HMR for ``infectious substances.'' 
(Note that Section 171.14(c)(3) provides for limited intermixing of old 
and new requirements).
    RSPA is issuing this extension of the compliance dates without 
prior notice and comments because we view this as a noncontroversial 
and necessary amendment and do not anticipate any adverse comments. 
However, if RSPA receives comments by September 30, 1994, that 
illustrate that an extension of the compliance dates is not in the 
public interest, RSPA will remove this final rule and propose another 
date. If no such comments are received, RSPA will publish a document in 
the Federal Register confirming the compliance dates.

Rulemaking Analyses and Notices

Executive Order 12866 and DOT Regulatory Policies and Procedures

    This final rule is exempted from review by the Office of Management 
and Budget under Executive Order 12866. Although the underlying rule 
was significant under the Regulatory Policies and Procedures of the 
Department of Transportation (44 FR 11034), this action is not 
significant because it does not impose additional requirements and has 
the effect of extending compliance dates. A regulatory evaluation for 
the December 20, 1991 final rule is available for review in the docket.

Executive Order 12612

    This final rule has been analyzed in accordance with the principles 
and criteria contained in Executive Order 12612 (``Federalism''). 
Federal law expressly preempts State, local, and Indian tribe 
requirements applicable to the transportation of hazardous material 
that cover certain subjects and are not substantively the same as 
Federal requirements. 49 U.S.C. 5125(b)(1). These subjects are:
    (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 
pertaining to hazardous material and requirements respecting the 
number, contents, and placement of those documents;
    (D) The written notification, recording, and reporting of the 
unintentional release in transportation of hazardous material; or
    (E) The design, manufacturing, fabrication, marking, maintenance, 
reconditioning, repairing, or testing of a package or container 
represented, marked, certified, or sold as qualified for use in 
transporting hazardous material.
    This final rule concerns classification, packaging, labeling, and 
marking of hazardous material. Therefore, this final rule preempts 
State, local, or Indian tribe requirements that are not substantively 
the same as Federal requirements on these subjects.
    Section 5125(b)(2) of title 49 U.S.C. provides that when DOT issues 
a regulation concerning any of the covered subjects, after November 
1990, DOT must determine and publish in the Federal Register the 
effective date of Federal preemption. That effective date may not be 
earlier than the 90th day following the date of issuance of the final 
rule and no later than two years after the date of issuance. RSPA has 
determined that the effective date of Federal preemption of this final 
rule will be April 3, 1995. Because RSPA lacks discretion in this area, 
preparation of a federalism assessment is not warranted.

Regulatory Flexibility Act

    This rule affects shippers and carriers of infectious substances 
and regulated medical waste, some of whom may be small entities. The 
effect of the rule is to provide regulatory relief to these entities. 
Therefore, I certify that this rule will not have a significant 
economic impact on a substantial number of small entities.

Paperwork Reduction Act

    This amendment does not impose information collection or 
recordkeeping requirements.

List of Subjects in 49 CFR Part 171

    Exports, Hazardous materials transportation, Hazardous waste, 
Imports, Incorporation by reference, Reporting and recordkeeping 
requirements.

    In consideration of the foregoing, 49 CFR Part 171 is amended as 
set forth below:

PART 171--GENERAL INFORMATION, REGULATIONS, AND DEFINITIONS

    1. The authority citation for Part 171 is revised to read as 
follows:

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

    2. In Sec. 171.14, paragraph (b)(6)(iii) is removed, paragraphs 
(b)(6) and (b)(7) are redesignated as paragraphs (b)(5) and (b)(8), 
respectively, and new paragraphs (b)(6) and (b)(7) are added to read as 
follows:


Sec. 171.14  Transitional provisions for implementing requirements 
based on the UN Recommendations.

* * * * *
    (b) * * *
    (6) January 1, 1995. On January 1, 1995, all applicable regulatory 
requirements, including those pertaining to classification (see 
Sec. 173.134 of this subchapter), hazard communication, and packaging, 
are effective for Division 6.2 materials (infectious substances) other 
than regulated medical waste and infectious substances affecting 
animals only.
    (7) October 1, 1995. On October 1, 1995, all applicable regulatory 
requirements, including those pertaining to classification (see 
Sec. 173.134 of this subchapter), hazard communication, and packaging 
are effective for regulated medical waste (Division 6.2) and infectious 
substances affecting animals only (Division 6.2).
* * * * *
    Issued in Washington, DC on September 20, 1994, under authority 
delegated in 49 CFR Part 1.
D.K. Sharma,
Administrator.
[FR Doc. 94-23566 Filed 9-21-94; 8:45 am]
BILLING CODE 4910-60-P