Infectious Substances; Proposed Rule DEPARTMENT OF TRANSPORTATION

SUMMARY: RSPA is proposing to revise the regulations pertaining to

infectious substances, including regulated medical waste (RMW), based

on petitions for reconsideration and comments received following

issuance of a final rule in December 1991, comments received in

response to an advance notice of proposed rulemaking issued in March

1993, and agency initiative. RSPA is proposing to clarify that RMW is a

subcategory of infectious substances; allow RMW to be offered for

transportation and transported if it conforms to certain requirements

of the Occupational Safety and Health Administration; add provisions

for transporting RMW by aircraft; and make other changes to clarify the

regulatory provisions applicable to infectious substances. The proposed

changes are intended to ensure the safe transportation of infectious

substances, provide relief from certain requirements of the hazardous

materials regulations in those instances where other Federal agency

regulations achieve an acceptable level of safety for transportation of

RMW, and clarify provisions which were adopted in the December 1991

final rule.

RSPA also is announcing a public meeting to solicit comments on the

proposals contained in this document.

DATES: Comments. Comments must be submitted on or before March 21,

1995.

Public Meeting. A public meeting will be held from 9:30 a.m. to 5

p.m. on January 17, 1995, in Washington, DC.

ADDRESSES: Comments: Address comments to the Dockets Unit (DHM-30),

Hazardous Materials Safety, Room 8421, RSPA, U.S. Department of

Transportation, 400 Seventh St., SW., Washington, DC 20590-0001.

Comments should identify the docket number (HM-181G) and Notice number

(94-11) 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 20590-0001. Office hours are 8:30 a.m. to 5 p.m., Monday

through Friday, except on public holidays when the office is closed.

Public Meeting: The public meeting will be held at the Federal

Aviation Administration Auditorium, 3rd Floor, Building FOB 10A,

Washington, DC. Any person wishing to present an oral statement at the

public meeting should notify Jennifer Antonielli, by telephone or in

writing, by January 12, 1995. Each request must identify the speaker;

organization represented, if any; daytime telephone number; and

anticipated length of presentation, not to exceed 10 minutes. It is

requested that written text of the oral presentation be presented to

the presiding officer prior to the oral presentation. The meeting may

conclude before 5:00 p.m. if all persons wishing to speak have been

heard.

FOR FURTHER INFORMATION CONTACT: Eileen Martin or Jennifer Antonielli,

Office of Hazardous Materials Standards, (202) 366-4488, Research and

Special Programs Administration, U.S. Department of Transportation, 400

Seventh Street, SW., Washington, DC 20590-0001.

SUPPLEMENTARY INFORMATION:

Table of Contents:

I. Background

II. Final Rule Extending Compliance Dates

III. Response to Petitions for Reconsideration

IV. General Summary of the ANPRM

V. Proposed Rule

VI. Scope of Future Work

VII. Regulatory Analyses and Notices

I. Background

History of Department of Transportation Regulation of Etiologic Agents/

Infectious Substances

A. Regulation Prior to 1991

The Hazardous Materials Regulations Board (Board; a predecessor to

the RSPA) adopted a final rule under Docket HM-142 on September 30,

1972 (37 FR 20554), that added ``etiologic agents'' to the list of

hazardous materials regulated by the Secretary. The final rule at 49

CFR 173.386(a)(1) defined an etiologic agent as

a viable microorganism, or its toxin, which causes or may cause

human disease, and is limited to those agents listed in 42 CFR

72.25(c) of the regulations of the Department of Health, Education,

and Welfare.

(The Department of Health, Education, and Welfare (HEW) is now the

Department of Health and Human Services (DHHS)). The final rule at 49

CFR 173.387 also specified packaging requirements for etiologic agents,

and excepted, at 49 CFR 173.386(d), from DOT regulation ``diagnostic

specimens'' and ``biological products,'' which were subject to

regulation by HEW. The final rule was adopted after notice and

opportunity to comment (36 FR 25163, December 29, 1971).

On November 29, 1972, after receiving two petitions for

reconsideration and several comments, the Board proposed in the Federal

Register (37 FR 25243) to except from DOT regulation cultures of

etiologic agents of less than 50 milliliters (1.666 fluid ounces) in

one package. The petitions stated that such an exception was necessary

to allow physicians in rural areas to transport cultures to

laboratories on passenger-carrying aircraft, rather than by slower

surface transportation which, in turn, promotes health safety. The

petitions added that cultures of etiologic agents may perish if in

transportation too long. The Board adopted the proposal as final on

March 29, 1973 (38 FR 8161). One commenter objected to excepting such

quantities of etiologic agents from all regulation. The Board noted,

however, that quantities of etiologic agents excepted from DOT

regulation would still be subject to HEW labeling and packaging

regulations under 42 CFR 72.25(c). The March 29, 1973 rule also adopted

incident notification requirements for etiologic agents, as proposed on

July 22, 1972 (37 FR 14728).

B. The 1988 notice of proposed rulemaking (NPRM) under Docket HM-142A

On November 10, 1988, RSPA proposed (Docket HM-142A, 53 FR 45525)

to revise the definition of ``etiologic agent,'' remove the 50

milliliter (ml) exception, and align the per package quantity limits of

etiologic agents aboard aircraft with the International Civil Aviation

Organization Technical Instructions for the Safe Transport of Dangerous

Goods by Air (ICAO Technical Instructions). RSPA proposed broadening

the definition of ``etiologic agent'' to include, in addition to

etiologic agents listed by DHHS (Centers for Disease Control and

Prevention (CDC)) in 42 CFR 72.3, any agent that poses a similar degree

of hazard, such as the human immunodeficiency virus (HIV). RSPA noted

that the proposed definition was not as broad as the definition for

infectious substances (Division 6.2) contained in the United Nations

Recommendations on the Transport of Dangerous Goods (UN

Recommendations) and international regulations based on the UN

Recommendations, such as the ICAO Technical Instructions. CDC has not

updated the list in 42 CFR 72.3 since July 1, 1980 (45 FR 48627). On

March 2, 1990 (55 FR 7678), CDC proposed to delete the list from its

regulations and adopt criteria to define ``etiologic agent,'' but a

final rule has not been published.

C. January 3, 1991 final rule under Docket HM-142A

On January 3, 1991, RSPA published a final rule in the Federal

Register (56 FR 197) under Docket HM-142A. The final rule (1) adopted a

revised definition of ``etiologic agent,'' (2) removed the 50 ml

exception, and (3) clarified quantity limitations for etiologic agents

transported aboard aircraft. ``Etiologic agent'' was defined to mean

a viable microorganism, or its toxin, which is listed in 42 CFR 72.3

of the regulations of the [CDC] or which causes or may cause severe,

disabling or fatal human disease.

The definition adopted differed from the proposed definition in

response to commenters who suggested that the language of the

definition be modified to better reflect agents that may pose an

unreasonable risk to health and safety during transportation.

Accordingly, the wording was revised to include other agents that cause

or may cause severe, disabling or fatal human diseases in humans in

addition to the agents listed in 42 CFR 72.3 of the CDC regulations. In

response to comments, RSPA indicated in the preamble that it believed

most medical waste is composed of material that does not contain

etiologic agents, either because it does not contain any infectious

material or because the infectious material does not meet the

regulatory definition of etiologic agent. RSPA also stated that, in

many cases, if medical waste is known or suspected to contain an

etiologic agent, it is treated on-site to destroy the agent by using a

method such as incineration, autoclaving, or treatment with

disinfectants. However, RSPA clearly stated that ``* * * if an

infectious waste that contains an etiologic agent is offered for

transportation, it must conform with the requirements in the Hazardous

Materials Regulations (HMR; 49 CFR parts 171-180) for etiologic

agents'' (56 FR 198). As stated earlier, the final rule also removed

the 50 ml exception, as proposed in 1988. The January 3 preamble

responded to numerous comments received on the 50 ml proposal and

comprehensively discussed the reasons for this action.

The January 3 preamble also discussed the relationship of Docket

HM-142A to Docket HM-181. Docket HM-181, entitled ``Performance-

Oriented Packaging Standards; Miscellaneous Amendments,''

comprehensively revised the HMR by eliminating 350 pages of regulation

and harmonizing HMR requirements for classification, hazard

communication and packaging with standards in the UN Recommendations.

In the preamble discussion, RSPA stated that HM-181 had proposed to

replace the term ``etiologic agent'' with ``infectious substance'' for

consistency with international regulations. However, RSPA noted that

the scope of changes proposed under HM-181 was so extensive that RSPA

was unsure when that proposal would be adopted as final. As a result,

RSPA proceeded with a separate rulemaking under Docket HM-142A (an

abbreviated version of the infectious substance provisions in HM-181)

to ensure that the risks posed by etiologic agents were adequately

regulated under the HMR. RSPA intended the provisions under HM-142A to

serve as a transition until the provisions of HM-181 became effective.

Both final rules were published at approximately the same time.

However, the initial effective date for HM-142A was February 19, 1991,

and the effective date for HM-181 was October 1, 1991. Although HM-142A

was to become effective before HM-181, RSPA encouraged shippers to

implement the HM-181 provisions as soon as practicable.

D. Performance-oriented packaging standards--HM-181

In 1987, RSPA proposed to align the classification, packaging, and

hazard communications provisions in the HMR with the UN Recommendations

and the ICAO Technical Instructions. The May 5, 1987 NPRM (Docket HM-

181, 52 FR 16482) proposed to replace the term ``etiologic agent'' with

the term ``infectious substance'' and adopt the INFECTIOUS SUBSTANCE

label (52 FR 16700). RSPA proposed to include ``infectious substance''

in UN classification Class 6, Division 6.2. ``Infectious substance''

was proposed to mean

a viable microorganism, or its toxin, which causes or may cause

human disease, and is limited to those agents listed in 42 CFR 72.3

of the regulations of the [CDC]. The terms ``infectious substance''

and ``etiologic agent'' are synonymous.

(52 FR 16700).

On December 21, 1990, RSPA issued a final rule under Docket HM-181

(55 FR 52402) which comprehensively revised the HMR with respect to

hazard communication, classification, and packaging requirements.

``Infectious substance'' was defined in 49 CFR 173.134(a)(1) to mean

a viable microorganism, or its toxin, which causes or may cause

disease in humans or animals, and includes those agents listed in 42

CFR 72.3 of the regulations of the [CDC] or any other agent that has

the potential to cause severe, disabling or fatal disease. The terms

``infectious substance'' and ``etiologic agent'' are synonymous.

RSPA had planned to issue a final rule under Docket HM-142A (etiologic

agents) before issuing the final rule under Docket HM-181. However, the

final rule under HM-181 was issued on December 21, 1990, and the final

rule under HM-142A was not issued until January 3, 1991. As explained

in the preamble to the January 3, 1991 rule, the comments on HM-142A

were considered in the decisionmaking process for HM-181, and reflected

in the December 21, 1990 rule. For example, not only did the December

1990 definition of ``infectious substance'' adopt the broader

definition of etiologic agent proposed in 1988, it also reflected

RSPA's consideration of comments suggesting that the language be

modified to better define agents that may pose an unreasonable risk to

health and safety during transportation.

A document incorporating editorial and substantive revisions to the

December 1990 final rule was published on December 20, 1991 [56 FR

66124]. (These final rules are referred to jointly herein as Docket HM-

181.) The revisions contained in the December 1991 rule were primarily

in response to petitions for reconsideration received on the December

1990 final rule. The December 1991 rule also made editorial and

technical corrections to the December 21, 1990 final rule, and to the

January 3, 1991 final rule.

E. Petition for reconsideration on the January 3, 1991 rule

A petition for reconsideration filed by the National Solid Wastes

Management Association (NSWMA) recommended that RSPA revise the

definition of infectious substances (etiologic agents) to exclude solid

waste or medical waste as defined in 40 CFR 259.10 of the Environmental

Protection Agency (EPA) regulations. To allow adequate time to evaluate

the petition, RSPA delayed the effective date of the January 3 rule to

September 30, 1991 (February 22, 1991, 56 FR 7312). In a meeting to

obtain clarification of the petition, NSWMA urged RSPA to reestablish

the 50 ml exception for infectious substances. The NSWMA stated that

RSPA's regulation was inconsistent with the approach taken by EPA, and

would increase the costs of transporting medical waste for the

regulated community. The NSWMA stated that, contrary to RSPA's preamble

discussion that most medical waste did not contain etiologic agents or

was treated on-site to destroy the agent before being transported for

disposal, substantial quantities of untreated medical waste are

transported off-site. This information was the first indication RSPA

had received from any commenter that removal of the 50 ml exception

would affect a larger segment of the industry than had previously been

indicated.

On September 18, 1991 (56 FR 47158), RSPA incorporated HM-142A into

HM-181 and, in partial response to NSWMA's request, extended the 50 ml

exception from October 1, 1991, to October 1, 1992. (The September 1991

rule also required that packages exceeding the 50 ml exception comply

on October 1, 1991, with the revised hazard communication (shipping

paper, marking, and labeling) and classification requirements in Docket

HM-181). RSPA anticipated that this extension would provide enough time

to fully respond to NSWMA's comments in the final correction document

to HM-181 that was being prepared. However, NSWMA submitted a September

26, 1991 letter asking that RSPA clarify that the January 3, 1991 and

September 18, 1991 final rules ``apply to only isolated cultures or

stocks such as clinical laboratory specimens and not to 'medical waste'

as defined in 40 CFR 259.30(a) and 'mixtures' as defined in 40 CFR

259.31.'' In essence, NSWMA was requesting clarification that the HMR

did not apply to medical waste containing any amount of an infectious

substance. In order to allow RSPA additional time to carefully review

NSWMA's substantive concerns, RSPA again extended the compliance date

for all new requirements for infectious substances until October 1,

1992 (October 1, 1991, 56 FR 49830).

F. December 20, 1991 final rule

In the December 20, 1991 final rule responding to petitions for

reconsideration in Docket HM-181, RSPA agreed with NSWMA that medical

waste containing an infectious substance should be treated differently

than other infectious substances. RSPA had no basis, however, to except

from regulation medical waste containing an infectious substance, and

stated ``* * * since the majority of these wastes are untreated and,

thus, may potentially contain infectious substances, RSPA strongly

believes that the public and transport personnel be protected from the

hazards of these materials during transportation'' (56 FR 66142).

Accordingly, RSPA revised the regulations (49 CFR 173.197 (1991)) to

specify ``* * * less rigorous requirements for infectious substances

that are `regulated medical wastes''' (56 FR 66131). RSPA observed that

EPA's regulations on medical waste in 40 CFR Part 259 had applied in

only five States and had expired on June 22, 1991, with the end of a 2-

year demonstration program that EPA had established under the Medical

Waste Tracking Act of 1988 (MWTA; Pub.L. 100-582). To provide less

rigorous requirements for medical waste containing infectious

substances, RSPA turned to the expired EPA regulations as a model that

could be adapted, with some modifications, to the HMR. RSPA wanted to

take advantage of the technical expertise and knowledge of the medical

waste industry that EPA had developed during its demonstration project

under the MWTA. Accordingly, RSPA adopted a definition of ``regulated

medical waste'' (to distinguish between all medical waste and medical

waste containing an infectious substance) and specified packaging

requirements for regulated medical waste (RMW) that were consistent

with those contained in the expired EPA regulations.

RSPA thus identified a subcategory of Division 6.2 (infectious

substances) materials, i.e., RMW, which is an infectious substance that

is contained in or constitutes medical waste, and provided packaging

requirements for RMW that were less rigorous than those for other

infectious substances.

Under the December 1991 rule, if an infectious substance is offered

for transportation or transported, the infectious substance must be

labeled, packaged, and offered for transportation in accordance with

the HMR, unless it meets one of the exceptions from regulation. The

1991 rule provided that if the infectious substance was a medical

waste, or was contained in medical waste, then a shipper could use the

less rigorous packaging requirements that were provided for RMW.

If RSPA had not provided this measure of regulatory relief in

response to petitions, all infectious substances, regardless of how

they are generated, would be classified and described as Division 6.2

materials, and would be subject to the full extent of regulation

provided in the HMR.

G. Petitions for reconsideration and comments received in response to

the December 20, 1991 rule

Following issuance of the December 1991 rule, RSPA received

additional petitions for reconsideration and a number of requests for

clarification and additional comments concerning the provisions for

infectious substances and regulated medical waste. The petitioners

requested a stay in the effectiveness of the final rule and the

reopening of the rulemaking for additional public input.

Petitions were submitted by the American Hospital Association

(AHA), the Association for Practitioners in Infection Control, Inc.

(APIC), and the Conference on Safe Transportation of Hazardous

Articles, Inc. (COSTHA). The petitioners asserted that RSPA violated

the Administrative Procedure Act (5 U.S.C. 553; ``APA'') by adopting

new requirements for medical waste in the December 20, 1991 rule

without providing an opportunity for comment; did not adequately assess

the risks associated with RMW in transportation and the costs and

benefits of regulation; and did not coordinate with other Federal

agencies to prevent imposition of conflicting regulations.

Petitioners also contended that the RMW requirements in the HMR

conflict with information contained in the report entitled ``The Public

Health Implications on Medical Waste: A Report to Congress,'' prepared

in 1990 by the Agency for Toxic Substances and Disease Registry (ATSDR)

on the Medical Waste Tracking Act. The ATSDR Report contains a

compilation of information obtained from several State health and

environmental departments on the amount and types of medical waste

generated and health and environmental implications of medical waste in

the United States. The report concludes that infection outside the

health care setting is not likely, and public health is not likely to

be adversely affected by medical waste in transportation.

COSTHA also asserted that RSPA changed the definition of infectious

substances to include substances ``infectious to animals only'' without

providing an opportunity to comment.

H. Advance notice of proposed rulemaking

On March 3, 1993, RSPA issued an advance notice of proposed

rulemaking (ANPRM) and announced a public meeting under Docket HM-181G

(58 FR 12207) concerning the issues raised by petitioners and

commenters and the need for additional regulatory changes pertaining to

infectious substances. In order to provide time to evaluate the

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 these issues. 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.

II. Final Rule Extending Compliance Dates

In a final rule published on September 22, 1994 (59 FR 48762), RSPA

revised 49 CFR 171.14(b) to once again delay compliance dates. For

regulatory requirements for RMW and for materials infectious only to

animals, the compliance date was extended from October 1, 1994, to

October 1, 1995. This time period should be adequate for RSPA to

evaluate comments received in response to this Notice, and make any

necessary changes to the HMR based on the merits of those comments.

For other infectious substances, e.g., for cultures and stocks of

substances infectious to humans, the compliance date was extended from

October 1, 1994, to January 1, 1995. The provisions for these materials

generally were not at issue in comments or petitions to the December

1991 final rule. The principal effects 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 (infectious substances)

classification, broadening 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 ml 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. The interested reader

is directed to the final rule for further information concerning the

extension of compliance dates.

III. Response to Petitions for Reconsideration

With respect to the issue of providing notice and comment, the

December 20, 1991 final rule was issued to correct obvious errors and

respond to over 250 petitions for reconsideration of the final rule

published on December 21, 1990. The rulemaking proceeding under HM-181

spanned over 10 years, provided numerous opportunities for public

comment (with over 2,500 comments received), and complied fully with

the requirements of the APA. Similarly, the final rule issued under HM-

142A was preceded by an NPRM and opportunity to comment.

The specific criteria and provisions for medical waste were

contained in the December 20, 1991 final rule to provide relief from

the more burdensome infectious substances packaging requirements

adopted in the December 21, 1990 final rule. Relief was provided in

response to petitions for reconsideration stating that packaging

prescribed in Sec. 173.196 would be both cost-prohibitive and

impractical for medical waste and that, rather than being treated on-

site, significant quantities of medical waste containing infectious

substances were routinely transported off-site for treatment or

disposal. The relief granted for medical waste was well within the

scope of the NPRM and the final rule.

Infectious substances, including medical waste containing

infectious substances, are regulated under the HMR and have been since

1973. For various reasons, many generators and transporters of medical

waste may not have been fully aware of these requirements. The change

in the definition of an etiologic agent/infectious substance under

Dockets HM-142A and HM-181, coupled with the elimination of the 50 ml

exception, increased both the awareness of this issue and the

likelihood that more medical waste would be subject to the HMR.

Moreover, the petitions appeared to be based on a misconception that

RSPA intended to regulate all medical waste, rather than only that

medical waste containing an infectious substance. To the extent that

there existed any confusion regarding the scope of RSPA's regulation of

medical waste, the notice published today sets forth a proposed

definition of RMW that clearly limits RMW to a waste containing an

infectious substance. Accordingly, in this notice, RSPA is giving those

persons who may have been unaware of, or confused by, the previous

requirements an opportunity to comment on the proposals.

With regard to analysis of risk and economic impact, in the

regulatory evaluation for HM-181, RSPA performed a macroscopic analysis

of costs and benefits generically addressing all hazardous materials,

their packagings, and impacts of changes to classification and hazard

communication. The HMR address tens of thousands of hazardous materials

and over 100 different types of packagings. Under HM-181, it was not

feasible or necessary to specifically analyze each hazardous material

or category of materials or each type of packaging and determine that

the benefits of change to classification, hazard communication or

packaging for each would outweigh associated costs. The benefits of the

system put in place under HM-181, involving the assessment of levels of

hazard for materials and assignment of packagings based on levels of

hazard, were demonstrated to greatly exceed the costs of the system.

RSPA did not receive any comments in response to the notices in Dockets

HM-181 or HM-142A on any economic impacts the rule would have on the

medical waste industry. Therefore, RSPA disagrees with the petitioners

who claimed that RSPA did not adequately assess costs and benefits

attributable to changes to regulatory requirements, particularly with

regard to medical waste. For this notice, RSPA has prepared a

regulatory evaluation and is providing an opportunity to comment on the

proposals.

With respect to other Federal regulation of infectious substances,

RSPA has participated in a number of interagency meetings to exchange

information on the Federal regulations and identify any duplication,

conflict, gaps, or discrepancies. As discussed in greater detail under

Section VI of this notice, RSPA intends to continue to cooperate with

other Federal agencies to harmonize requirements on infectious

substances. With respect to State regulation, RSPA is aware that many

States have regulations on the transportation of medical waste,

although the States vary in the extent and scope of their regulation.

As discussed in Section VII.B. below, Federal law preempts State

requirements applicable to the transportation of hazardous material

that cover certain subjects and are not substantively the same as the

Federal requirements. 49 U.S.C. 5125(b)(1). These subjects include the

designation, description, classification, packaging, handling, marking,

and labeling of hazardous material.

With respect to the ATSDR Report, that report addressed all medical

waste generated in the United States. RSPA is concerned only with

regulating medical waste that contains an infectious substance, and is

proposing to regulate only that medical waste.

With respect to COSTHA's petition concerning substances infectious

only to animals, in the November 1987 NPRM under Docket HM-181, RSPA

had proposed a shipping description for ``Infectious substances,

affecting animals only'', applicable only to international

transportation (i.e., identified with an ``I'' in Column 1 of the

Hazardous Materials Table in Sec. 172.101). In the December 1990 final

rule, RSPA removed the ``I'', making the description applicable to both

domestic and international transportation, and revised the definition

for infectious substances to include those affecting animals only. This

action was taken to harmonize with the UN Recommendations to the

maximum extent practicable. In response to COSTHA's petition, RSPA is

providing notice and opportunity to comment on the proposal in this

NPRM.

Conclusion

By initiating rulemaking, including issuance of the ANPRM and this

NPRM, RSPA has granted the petitioners' requests to provide notice and

an opportunity to comment on provisions concerning RMW and infectious

substances that are infectious to animals only. RSPA agrees with the

petitioners and commenters that the HMR should be carefully tailored to

the hazards posed by these materials, so that they can be safely

transported without imposing unreasonable requirements on industry. To

the maximum extent practicable, RSPA is proposing to accommodate RMW

prepared in accordance with other Federal regulations, as discussed in

Section V of this notice. Furthermore, RSPA is proposing to amend and

clarify certain provisions that are frequently misconstrued.

IV. General Summary of the ANPRM

The ANPRM was issued to invite interested persons to participate in

the rulemaking process by submitting views and information on issues

concerning Division 6.2 materials. RSPA asked 29 questions in the

ANPRM. The questions addressed areas in the HMR that were identified as

problem areas in comments and petitions received following issuance of

the December 1991 final rule. RSPA requested information on a number of

complex issues including the burdens of compliance with the HMR and

other Federal regulations, the need for revised packaging standards,

the need to expand or narrow the definitions for infectious substances

and RMW, and the costs incurred to manage these materials in

transportation. RSPA requested commenters to provide as much

quantitative information as was available concerning costs and benefits

attributable to their recommendations.

RSPA received approximately 54 written comments in response to the

ANPRM and 13 oral comments at the public meeting. Comments were

submitted by a variety of organizations, including associations

representing hospitals, blood centers and laboratories, disposal

service companies, Federal and State agencies, packaging manufacturers,

and private individuals. In responding to the ANPRM, some commenters

submitted views on issues not specifically addressed in the ANPRM.

The commenters provided widely divergent views on the extent to

which the regulations should be revised or amended. Some commenters

believed that RSPA should adopt a ``universal precautions'' approach,

as utilized by the Occupational Safety and Health Administration (OSHA)

of the Department of Labor in regulations applicable to bloodborne

pathogens (29 CFR 1910.1030); that is, all materials that are

potentially infectious are treated as if known to be infectious. Others

suggested that RSPA should withdraw from regulation of infectious

substances and RMW, asserting that other agencies' regulations provide

an adequate level of safety in transportation. Several commenters

claimed that the regulation of RMW was best left to the EPA, even

though EPA regulation of RMW ended in 1991.

Several commenters provided information on the overall quantities

and costs of disposal for medical waste. However, there was not much

useful information as to what portion of that waste stream was subject

to RSPA requirements, either before or after the HM-181 final rules,

incremental costs or savings resulting from the December 1991 final

rule, or even what portion of the disposal costs were the result of

regulatory requirements. Commenters estimated varying disposal costs

from $0.10 to $2.00 per pound.

V. Proposed Rule

After considering the comments and petitions for reconsideration

that were filed, and following an examination of the issues surrounding

the transportation of infectious substances and RMW, RSPA is limiting

the proposals in this notice to those issues concerning infectious

substances and RMW that must be addressed in the short term to ensure

safe transportation of these materials without unduly impacting the

regulated industry. RSPA intends to address other pertinent issues,

such as harmonizing the HMR with international regulations, adopting

bulk packaging provisions for RMW, and evaluating the adequacy of

existing Federal regulations for biological products and diagnostic

specimens, in future rulemaking action. Although these issues are

important, they are complex and may result in additional requirements

or substantial changes to the HMR. Thus, it is not appropriate to

include them in this notice, except to discuss them in terms of future

action. The ``long-term'' issues are discussed further in Section VI of

this notice.

In this NPRM, RSPA is proposing to amend the provisions of the HMR

applicable to Division 6.2 materials to enhance the effectiveness of

the HMR and minimize costs incurred by industry. Interested persons are

invited to comment on these proposals. A public meeting will be held on

January 17, 1995, at which oral comments are invited.

A. Definitions

Several commenters requested confirmation of their understanding

that the provisions for RMW do not apply to sterilized medical wastes

or wastes that do not contain an infectious substance. This

understanding is correct. As stated in the preamble to the January 3,

1991 final rule, if a medical waste has been treated so as to eliminate

its hazard as an infectious substance, then it is not subject to the

HMR. No additional processing of the waste for aesthetics, such as that

formerly required by the EPA under the MWTA, is required. To clarify

this point, RSPA is proposing to revise Sec. 173.134 by adding

exceptions for any material that contained an infectious substance but

has been treated to eliminate the hazard. In addition, consistent with

EPA-provided exceptions under the MWTA regulations and based on RSPA's

own initiative, RSPA is proposing to clarify that the following

materials are not considered RMW: (1) EPA hazardous wastes; (2)

household waste; (3) corpses, remains, and anatomical parts intended

for ceremonial interment or cremation, and (4) animal waste generated

in animal husbandry or food production.

Based on commenters' requests and RSPA's initiative, RSPA is

proposing to simplify the definition of RMW by adopting a criteria-

based definition, rather than a list-based definition. The definition

in Appendix G to part 173 did not specify that a category of waste,

such as ``unused sharps,'' was only regulated if the waste contained an

infectious substance. RSPA never intended to regulate medical waste

that does not contain an infectious substance. Therefore, RSPA is

proposing to revise the definition of RMW to remove the Appendix G

categories and replace them with a generic definition. RMW would be

defined as a waste or reusable material, other than a Class 7

(radioactive) material or a culture or stock of an infectious

substance, which contains an infectious substance and is generated in

the diagnosis, treatment or immunization of human beings or animals,

research pertaining thereto, or the production or testing of biological

products.

Another issue of concern to RSPA was whether waste cultures and

stocks should be treated as RMW or as infectious substances for the

purposes of packaging and hazard communication for transportation.

Several commenters recommended that waste cultures and stocks should be

treated as infectious substances rather than as RMW. One commenter

stated that the hazards posed by these materials are the same

regardless of ``whether the untreated cultures and stocks are to

undergo further manipulation or are destined for disposal.'' Another

commenter stated that cultures and stocks demand very careful packaging

and handling. The commenter added that packagings required for most RMW

are not adequate for untreated cultures and stocks. Some commenters

stated that cultures and stocks should be handled as RMW because

optimal conditions for growth are no longer present in the waste stream

and most of these materials are sterilized before transportation. In

the case of the generators that cannot sterilize on-site, the Texas

Water Commission asserted that the quantity of these materials in the

waste stream is probably insufficient to make the waste significantly

more infectious than other forms of RMW.

RSPA agrees with those commenters who suggested that discarded

cultures and stocks, because of their concentration, pose a greater

degree of risk than other medical waste and should be treated as

infectious substances rather than RMW. Therefore, RSPA is proposing to

exclude untreated waste cultures and stocks from the definition of RMW

and subject them to the more rigorous packaging provisions applicable

to infectious substances other than RMW. RSPA does not believe that

this proposal will impose additional burdens on industry because, based

on comments, these materials are largely treated on-site prior to

disposal.

RSPA received comments stating that contaminated laundry and other

recyclable/reusable materials, such as used surgical instruments that

are cleaned and sterilized off-site, should be handled in accordance

with OSHA regulations. The OSHA regulations in 29 CFR 1910.1030 provide

that contaminated laundry shall be placed and transported in bags or

containers labeled or color-coded in accordance with paragraph

(g)(1)(i) of the OSHA regulations or, if utilizing universal

precautions, alternative labeling is permitted if it is recognizable to

all employees as requiring compliance with universal precautions. In

addition, OSHA requires contaminated laundry that is wet and presents a

reasonable likelihood of soak-through of or leakage from the bag or

container to be placed in bags or containers which prevent soak-through

and/or leakage of fluids to the exterior. One commenter stated that

since these waste materials are not considered hazardous wastes under

EPA regulations, they should not be RMW under DOT regulations. The

American Type Culture Collection suggested that laundry and surgical

instruments should only be regulated in transportation if they are

known to be infectious. To relieve the burden of dual compliance with

the HMR and OSHA regulations, RSPA is proposing to except contaminated

laundry and other reusable materials from the HMR if they are handled

in accordance with the OSHA requirements in 29 CFR 1910.1030.

In the ANPRM, RSPA reopened the issue of regulating infectious

substances affecting animals only. Several commenters objected to

regulating substances ``infectious to animals only.'' Commenters

suggested that RSPA include only those substances infectious to humans

and those infectious to humans and animals (zoonotic), but not those

infectious to animals only. Some commenters stated that the regulations

of the Animal and Plant Health Inspection Service (APHIS) of the United

States Department of Agriculture adequately covers substances

infectious to animals. One commenter suggested that if RSPA defers to

other regulations for these materials, the HMR should cross-reference

those Federal regulations.

Under the Federal hazardous material transportation law, RSPA must

regulate the transportation of materials that may pose an unreasonable

risk to health and safety or property. Animal pathogens may pose an

unreasonable risk to animals. Furthermore, RSPA has examined the APHIS

regulations contained in 9 CFR parts 1-199 and determined that they do

not address transportation concerns with regard to communication of

hazard, provision of emergency response information, and adequacy of

packaging. Therefore, in this notice, RSPA is proposing to regulate

Division 6.2 materials affecting animals only. Although the

requirements that were scheduled to go into effect on October 1, 1994,

included ``animals'' in the definition of ``infectious substance,''

RSPA has delayed the compliance date for these materials until October

1, 1995. See Section II for more information concerning the extension

of compliance dates. RSPA is requesting more comments on this issue.

RSPA received several requests to clarify that the terms

``biological product'' and ``diagnostic specimen'' do not include

materials that do not contain infectious substances. As previously

stated, RSPA does not intend to regulate materials that do not pose a

hazard in transportation. Therefore, for clarity, RSPA is proposing to

revise the definitions of ``biological product'' and ``diagnostic

specimen'' to include only those materials that contain an infectious

substance. RSPA also would clarify that the terms ``biological

product,'' ``diagnostic specimen,'' and ``regulated medical waste'' are

all subcategories of Division 6.2 materials.

B. RMW Exception

RSPA received several comments on the ANPRM claiming that the

regulations imposed by RSPA overlap, and sometimes conflict with,

regulations/guidelines established by other agencies, which

unnecessarily increases costs and confusion. One commenter suggested

that inconsistencies should be eliminated between Federal and State

regulations governing RMW. Another commenter stated that overlapping

regulations clearly increase non-compliance; however, the associated

costs are difficult to assess. One commenter asserted that current

Federal regulations do not appear to be financially burdensome but do

complicate compliance. One commenter claimed that overlapping Federal

regulations are not so much burdensome or costly, as that they are

largely ignored. Another commenter stated that varying medical waste

regulations increase the volume of waste that must be specially

handled. Many commenters requested consolidation of the regulations.

More specifically, commenters stated that the appearance of

multiple labels on a package of infectious substances causes

unnecessary confusion to transport workers and emergency responders.

One commenter claimed that multiple labels contribute to the

mismanagement of medical waste by transport workers and emergency

response personnel. Several commenters recommended that one label is

sufficient to communicate the hazard. One commenter suggested that the

CDC ``BIOMEDICAL MATERIAL'' label and the OSHA ``BIOHAZARD'' marking

should be allowed only on stationary materials and equipment. Some

commenters recommended that RSPA adopt the UN Recommendations label for

infectious substances because it is internationally recognized. One

commenter stated that appropriate worker training would eliminate much

of the confusion experienced by transport workers and emergency

response personnel.

RSPA recognizes that overlapping Federal regulations for infectious

substances and RMW cause confusion and result in frustrated shipments.

Therefore, RSPA is proposing to provide an exception from the HMR

labeling and packaging requirements for RMW, transported by private and

contract carriers, that is packaged in a packaging that complies with

OSHA requirements, is rigid, conforms to the general packaging

requirements of 49 CFR 173.24 and 173.24a, and is marked with the OSHA

``BIOHAZARD'' marking. This exception would be limited to transport by

private or contract carrier because these carriers generally transport

RMW exclusively and have the demonstrated ability to implement

appropriate handling procedures which offset potentially lesser

packaging integrity. RMW that is offered for transportation and

transported by common carrier would be subject to the packaging

requirements of Sec. 173.197. RSPA invites comments on this matter.

Other than this exception for RMW, RSPA is not proposing in this

NPRM to accept other agencies' labels or markings in place of the label

or marking requirements for infectious substances packagings. The

``INFECTIOUS SUBSTANCE'' label is internationally recognized, is

required under the ICAO Technical Instructions for transport by

aircraft, and is consistent in size and appearance with DOT's other

hazard warning labels. Unlike OSHA's ``BIOHAZARD'' marking, the DOT

label conveys the class number of the material, emergency information

in the event of a spill or incident, and has minimum size requirements

to ensure its visibility.

C. Miscellaneous

RSPA is proposing to relocate the exceptions for biological

products and diagnostic specimens in Sec. 173.196 and the definition

and exceptions for RMW in Appendix G to part 173 to Sec. 173.134 to

ease compliance. Also, in response to a question concerning use of the

term ``diagnostic specimen'' versus ``clinical specimen,'' many

commenters recommended that RSPA continue using ``diagnostic specimen''

instead of ``clinical specimen'' because the term ``diagnostic

specimen'' is commonly used in industry. RSPA agrees and would retain

the terminology. RSPA is proposing to amend the terminology used in the

incident reporting requirements in Sec. 171.15 from ``etiologic

agents'' to ``infectious substances (etiologic agents)''.

RSPA has received several requests for clarification as to whether

infectious substance packagings that successfully pass the tests in

Sec. 178.609 must be certified and marked. According to Sec. 173.196,

packagings for infectious substances are required to be capable of

passing the tests in Sec. 178.609. These packagings are not required to

be marked and certified. RSPA is proposing to add a provision in

Sec. 178.609 that clarifies that packagings conforming to this section

are not subject to the marking requirements of Sec. 173.503. However,

the eighth revised edition of the UN Recommendations prescribes

packaging certification marking requirements for infectious substances

packagings. Therefore, RSPA may propose similar requirements in the

interest of international harmonization, in future rulemaking action.

(See Section VI of this notice.)

RSPA would clarify in Sec. 173.134 that Division 6.2 materials

other than RMW are not assigned a packing group. RMW would be assigned

to a Packing Group II performance level.

D. Air Transportation

In response to a question in the ANPRM, RSPA received comments

concerning shipments of RMW by modes other than highway. Commenters

stated that RMW is transported predominantly by highway; however, other

modes of transportation also are used. Some commenters reported that

used sharps are transported by air through the U.S. Postal Service

(USPS) ``mail-in'' sharps program. RSPA received a petition requesting

an amendment to the HMR to permit the transportation of similar

quantities and packages of RMW by aircraft other than in mail. RSPA

also received comments from a number of health care facilities located

in rural areas, e.g., Alaska, requesting that the regulations

facilitate transportation of medical wastes by aircraft. The commenters

stated that health clinics in remote areas are only accessible by air

or water. Commenters reported that it is not practical for the air

carriers to provide cargo-only flights.

RSPA is proposing to add two special provisions that would permit

the transportation of RMW by aircraft. A new Special Provision ``A13''

would be added to allow the transportation of sharps aboard passenger

and cargo-carrying aircraft in quantities of not more than 16 kilograms

(35 pounds) per package and maximum liquid content of 50 milliliters

for each inner packaging. This provision is consistent with USPS

regulations for the mailability of used sharps under 39 CFR Part 111

and would serve to eliminate confusion as to whether sharps mailers are

acceptable for air transportation. RSPA also is proposing to add

Special Provision ``A14'' to allow shipments of RMW to be transported

by aircraft in quantities not exceeding 16 kilograms (35 pounds) for

solid waste and 12 liters (3 gallons) for liquid waste, when means of

transportation other than air are impracticable or unavailable. Even

though these provisions would not have any effect on the movement of

RMW until adopted, proposal of these provisions is intended to clarify

that sharps and RMW from Alaska and other remote areas are permitted

aboard aircraft. See Section VI of this preamble for possible future

rulemaking concerning quantity limitations aboard aircraft.

RSPA also is proposing to revise the I.D. number for RMW from a

domestic-only recognized I.D. number (NA 9275) to an internationally

recognized I.D. number (UN 3291). This proposed amendment is consistent

with the UN Recommendations and the ICAO Technical Instructions.

E. Proposed Extension of Compliance Date

RSPA intended to issue this notice of proposed rulemaking

simultaneously with the final rule which was published on September 22,

1994 (see Section II of this notice). Due to a delay in publication of

this notice, RSPA is proposing to extend the compliance date once again

for requirements applicable to regulated medical waste and infectious

substances affecting only animals from October 1, 1995, to January 1,

1996. This is intended to allow sufficient time for the public to

comment on the proposals contained in this notice, for RSPA to evaluate

the comments received, and, based on the merits of the comments,

publish a final rule. RSPA invites comments on the need for this

proposed extension.

VI. Scope of Future Work

RSPA believes that uniform standards, applicable to both domestic

and international transportation, are essential to ensuring the safe

and efficient movement of infectious substances. To this end, RSPA

continues to work with other Federal agencies and the United Nations

Subcommittee of Experts on the Transport of Dangerous Goods to improve

standards for classification, hazard communication, packaging and

operational control of infectious substances. The HMR are generally

consistent with the United Nations Recommendations on the Transport of

Dangerous Goods (UN Recommendations), although there are some

differences. RSPA anticipates proposing changes to the HMR in future

rulemaking concerning defining criteria, particularly the adoption of

risk groups and regulation of genetically-modified organisms and

microorganisms, and new shipping descriptions and marking requirements

for non-bulk packagings based on the UN Recommendations.

The ICAO Technical Instructions prescribe no air quantity limits

for RMW. RSPA may propose to align its air quantity limits for RMW with

the ICAO in future rulemaking action.

Transportation safety for all categories of infectious substances

(i.e., cultures and stocks, diagnostic specimens, biological products

containing infectious substances, and RMW) could be enhanced through

imposition of uniform classification, hazard communication and

packaging requirements. Both through rulemaking action and in working

with other Federal agencies, RSPA anticipates advocating standards

based on UN Recommendations, such as for the internationally-recognized

``INFECTIOUS SUBSTANCE'' label and for performance-oriented packaging.

RSPA intends to continue its review of the HMR and the regulations

of other Federal agencies and to work with these agencies to identify

and eliminate inconsistencies, overlaps, gaps and inadequacies in

regulatory coverage. Although RSPA is aware of allegations of

inconsistent regulations, RSPA has not identified any regulatory

impediment to compliance with the HMR and the regulations of other

agencies.

There are obvious overlaps between agency regulations, such as

differing labeling and packaging requirements of RSPA and the CDC for

cultures and stocks of infectious substances. CDC has expressed a

willingness to work with RSPA in resolving these differences through

changes to one or both agencies' regulations. There also are differing

labeling and packaging requirements of RSPA and OSHA for medical waste

as discussed in the proposed rule change elsewhere in this notice.

Although compliance with two or more differing agencies' regulations

may be burdensome, RSPA has not identified any situation where

compliance with one agency's regulations is a barrier to compliance

with another agency's regulations. However, RSPA agrees with

commenters' contentions that differing requirements cause confusion and

increase compliance costs and the likelihood of non-compliance based on

misunderstanding. RSPA intends to work with other Federal agencies to

eliminate overlaps, where feasible.

Of more concern to RSPA than overlapping requirements are gaps or

inadequacies of regulation which may impact transportation safety. RSPA

is particularly concerned that diagnostic specimens and biological

products known or suspected to contain infectious substances may be

transported with inadequate or no hazard communication (e.g., shipping

paper descriptions identifying them as hazardous, package markings and

labels to identify the hazard class and name of the hazardous material,

emergency response information specifying steps to be taken in the

event of an incident in transportation) and may be transported in

packagings which are inadequate for the conditions of transport and the

risks posed by the materials contained therein.

RSPA recognizes that the regulations under the Food and Drug

Administration (FDA) of the Department of Health and Human Services (21

CFR parts 312 and 600-680) and APHIS of the United States Department of

Agriculture (9 CFR parts 102-104) are designed to protect the safety,

potency, and purity of the biological product and are not specifically

intended to protect transport workers or the public against exposure to

biological products. RSPA also understands that CDC regulations in 42

CFR 72.3 govern packaging and labeling for diagnostic specimens that

are equivalent to the HMR for infectious substances. However,

regulatory gaps may exist in CDC's regulations because the list of

agents is outdated. For example, the list does not include HIV or Lyme

disease.

Because of the need for expeditious delivery, many biological

products and diagnostic specimens are transported by aircraft. Although

not subject to incident reporting requirements of the HMR, RSPA

understands that packages of these materials often are damaged in

transit aboard aircraft, causing costly delays and posing risks to

cargo handlers, emergency responders, others who may be exposed to the

materials and property. Although many commenters to the ANPRM on this

issue supported regulation of these materials under the HMR, RSPA is

not proposing to impose requirements on biological products and

diagnostic specimens at this time. RSPA would continue to except

biological products and diagnostic specimens from the HMR. RSPA

anticipates proposing deletion of exceptions for these materials, if

justified in terms of benefits versus costs, in future rulemaking

action. Other exceptions, such as those for hazardous wastes, may be

reconsidered at a future date if safety concerns warrant.

RSPA would authorize, by today's proposed rule, non-bulk, non-

specification packagings for RMW under specified conditions. RSPA

intends to monitor closely incident reports for these shipments to

ensure that the packaging and handling requirements achieve an

acceptable level of safety and, if not, will propose adjustments in

future rulemaking action.

Several other issues may be considered in future rulemaking action.

Although no bulk packagings for RMW are specified in the HMR, their use

is authorized under the provisions of a number of exemptions. RSPA

anticipates proposing to convert the provisions of some or all of these

exemptions into regulations of general applicability. RSPA currently

requires the segregation of poisons from foodstuffs. There may be

sufficient justification, in terms of safety, to impose similar

restrictions on all infectious substances or RMW only. RSPA is aware

that a number of States have differing vehicle marking requirements for

vehicles containing RMW. Although RSPA has not required a vehicle

marking to date, there may be a need to propose one. Finally, in the

interest of minimizing cost impacts on the regulated industry, RSPA did

not adopt vehicle placarding requirements for Division 6.2 materials.

For purposes of emergency response and international harmonization, it

may be beneficial to adopt an ``INFECTIOUS SUBSTANCE'' placard in

future rulemaking action.

VII. Regulatory Analyses and Notices

A. Executive Order 12866 and DOT Regulatory Policies and Procedures

This proposed rule is considered a significant regulatory action

under section 3(f) of Executive Order 12866 and, therefore, was

reviewed by the Office of Management and Budget. This rule is

significant under the Regulatory Policies and Procedures of the

Department of Transportation (44 FR 11034), because of substantial

public interest. A regulatory evaluation is available for review in the

docket.

B. Executive Order 12612

This proposed 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 the 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, content, 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 which

is represented, marked, certified, or sold as qualified for use in the

transportation of hazardous material.

This proposed rule concerns the classification, packaging,

labeling, and handling of hazardous material, among other covered

subjects.

If adopted as final, this rule would preempt any State, local, or

Indian tribe requirements concerning these subjects unless the non-

Federal requirements are ``substantively the same'' (see 49 CFR

107.202(d)) as the Federal requirements.

Federal law (49 U.S.C. 5125(b)(2)) provides that if DOT issues a

regulation concerning any of the covered subjects after November 16,

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 not later than two years after the date of issuance. RSPA

requests comments on what the effective date of Federal preemption

should be for the requirements in this proposed rule that concern

covered subjects.

C. Regulatory Flexibility Act

This proposed rule would revise the requirements for infectious

substances and regulated medical waste contained in the HMR by

narrowing the scope of these provisions. The proposed changes in this

rule would provide relief to shippers, carriers of infectious

substances and regulated medical waste, and some packaging

manufacturers, some of whom are small entities (e.g., medical clinics,

governmental jurisdictions, and not-for-profit organizations).

Therefore, I certify that this proposal will not, if promulgated, have

a significant economic impact on a substantial number of small

entities. This certification is subject to modification as a result of

a review of comments received in response to this proposal.

D. Paperwork Reduction Act

There are no new information collection requirements in this

proposed rule.

E. 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 numbers 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 171

Exports, Hazardous materials transportation, Hazardous waste,

Imports, Incorporation by reference, Reporting and recordkeeping

requirements.

49 CFR part 172

Hazardous materials transportation, Hazardous waste, Labeling,

Marking, 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 178

Hazardous materials transportation, Motor vehicle safety, Packaging

and containers, Reporting and recordkeeping requirements.

In consideration of the foregoing, 49 CFR parts 171, 172, 173, and

178 would be amended as follows:

PART 171--GENERAL INFORMATION, REGULATIONS, AND DEFINITIONS

1. The authority citation for part 171 would continue to read as

follows:

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

2. In Sec. 171.8, the following definition would be added in

appropriate alphabetical order:

Sec. 171.8 Definitions and abbreviations.

* * * * *

Regulated medical waste. See Sec. 173.134 of this subchapter.

* * * * *

Sec. 171.15 [Amended]

3. In Sec. 171.15, the wording ``etiologic agents'' in paragraphs

(a)(3) and (b) introductory text would be revised to read ``infectious

substances (etiologic agents)''.

PART 172--HAZARDOUS MATERIALS TABLE, SPECIAL PROVISIONS, HAZARDOUS

MATERIALS COMMUNICATIONS, EMERGENCY RESPONSE INFORMATION, AND

TRAINING REQUIREMENTS

4. The authority citation for part 172 would continue to read as

follows:

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

Sec. 172.101 [Amended]

5. In Sec. 172.101, in the Hazardous Materials Table, the following

changes would be made:

a. For the entry, ``Infectious substances, affecting animals

only'', in Column (8A), ``196'' would be removed and replaced with

``134''.

b. For the entry, ``Infectious substances, affecting humans'', in

Column (8A), ``196'' would be removed and replaced with ``134''.

c. For the entry, ``Regulated medical waste'', in Column (4), the

identification number ``NA9275'' would be removed and replaced with

``UN3291''; in Column (7), ``A13, A14'' would be added; and in Column

(8A), ``197'' would be removed and replaced with ``134''.

6. In Sec. 172.102, in paragraph (c)(2), Special Provisions A13 and

A14 would be added in alphanumeric sequence, to read as follows:

Sec. 172.102 Special provisions.

* * * * *

(c) * * *

(2) * * *

Code/Special Provisions

* * * * *

A13 Non-bulk packagings conforming to Sec. 173.197 of this

subchapter not exceeding 16 kilograms (35 pounds) gross mass

containing used sharps are permitted for transportation by aircraft.

Maximum liquid content in each inner packaging may not exceed 50

milliliters (1.7 ounces).

A14 Non-bulk packagings of regulated medical waste conforming to

Sec. 173.197 of this subchapter not exceeding 16 kilograms (35

pounds) gross mass for solid waste or 12 liters (3 gallons) total

volume for liquid waste may be transported by passenger and cargo

aircraft when means of transportation other than air are

impracticable or not available.

* * * * *

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

PACKAGINGS

7. The authority citation for part 173 would continue to read as

follows:

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

8. Section 173.134 would be revised to read as follows:

Sec. 173.134 Class 6, Division 6.2--Definitions, exceptions and

packing group assignments.

(a) Definitions. For the purposes of this subchapter, the

categories of materials that comprise Division 6.2 are defined as

follows:

(1) An infectious substance means a viable microorganism, or its

toxin, which causes or may cause disease in humans or animals, and

includes those agents listed in 42 CFR 72.3 of the regulations of the

Department of Health and Human Services and any other agent that causes

or may cause severe, disabling or fatal disease. The terms infectious

substance and etiologic agent are synonymous.

(2) A diagnostic specimen means any human or animal material being

shipped for purposes of diagnosis which contains an infectious

substance including, but not limited to, excreta, secreta, blood, blood

components, tissue, and tissue fluids.

(3) A biological product means a material which contains an

infectious substance and is prepared and manufactured in accordance

with the provisions of 9 CFR part 102 (Licenses for biological

products), 9 CFR part 103 (Experimental products, distribution, and

evaluation of biological products prior to licensing), 9 CFR part 104

(Permits for biological products), 21 CFR part 312 (Investigational new

drug application), or 21 CFR parts 600 to 680 (Biologics).

(4) A regulated medical waste means a waste or reusable material,

other than a Class 7 (radioactive) material or a culture or stock of an

infectious substance, which contains an infectious substance and is

generated in--

(i) The diagnosis, treatment or immunization of human beings or

animals;

(ii) Research pertaining to the diagnosis, treatment or

immunization of human beings or animals; or

(iii) The production or testing of biological products.

(b) Exceptions. (1) The following are not subject to any

requirements of this subchapter if the items as packaged do not contain

any material otherwise subject to the requirements of this subchapter:

(i) Biological products;

(ii) Diagnostic specimens;

(iii) Laundry or medical equipment which conforms to 29 CFR

1910.1030 of the regulations of the Occupational Safety and Health

Administration of the Department of Labor;

(iv) A material, including waste, which previously contained an

infectious substance, that has been treated by steam sterilization,

chemical disinfection, or other appropriate methods, so that it no

longer poses the hazard of an infectious substance;

(v) Household waste, i.e., any waste material, including garbage,

trash and sanitary waste in septic tanks, derived from households,

including single and multiple residences, hotels and motels;

(vi) Corpses, remains and anatomical parts that are intended for

ceremonial interment or cremation; and

(vii) Animal waste generated in animal husbandry or food

production.

(2) A hazardous waste is not subject to regulation as a regulated

medical waste.

(3) A regulated medical waste that is transported by a private or

contract carrier is excepted from--

(i) The requirement for an ``INFECTIOUS SUBSTANCE'' label if the

outer packaging is marked with a ``BIOHAZARD'' marking in accordance

with 29 CFR 1910.1030; and

(ii) The specific packaging requirements of Sec. 173.197, if

packaged in a rigid non-bulk packaging conforming to--

(A) The general packaging requirements of Secs. 173.24 and 173.24a;

and

(B) Packaging requirements specified in 29 CFR 1910.1030.

(c) Assignment of packing groups/applicable packaging sections. (1)

Division 6.2 materials, other than regulated medical waste, are not

assigned a packing group. Packaging requirements for these materials

are prescribed in Sec. 173.196.

(2) Except as otherwise provided, regulated medical waste is

assigned to Packing Group II and must be packaged as specified in

Sec. 173.197.

Appendix G [Removed]

9. Appendix G to part 173 would be removed.

PART 178--SPECIFICATIONS FOR PACKAGINGS

10. The authority citation for part 178 would continue to read as

follows:

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

11. In Sec. 178.609, paragraph (i) would be added to read as

follows:

Sec. 178.609 Test requirements for packagings for infectious

substances (etiologic agents).

* * * * *

(i) Packagings subject to this section are not subject to

Sec. 178.503 or any other requirements of this subpart, except

Sec. 178.608.

Issued in Washington, DC on December 14, 1994, under authority

delegated in 49 CFR part 106, appendix A.

Alan I. Roberts,

Associate Administrator for Hazardous Materials Safety.

[FR Doc. 94-31174 Filed 12-20-94; 8:45 am]

BILLING CODE 4910-60-P