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

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]

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