Infectious Substances

SUMMARY: RSPA published a notice of proposed rulemaking (NPRM) in

December 1994 that proposed to revise the regulations pertaining to

infectious substances, including regulated medical waste (RMW). In this

final rule, RSPA is revising requirements for Division 6.2 materials

(infectious substances). This rule clarifies the scope of regulation

for infectious substances, provides relief for certain shipments of RMW

that conform to other Federal agency regulations, allows certain

quantities of RMW to be transported by aircraft, and makes other

changes to clarify regulatory provisions applicable to infectious

substances. This rulemaking action is necessary to ensure that the

regulations for infectious substances and regulated medical waste are

cost effective and provide an adequate level of safety in

transportation.

DATES: Effective date. The effective date of these amendments is

October 1, 1995.

Compliance date. Voluntary compliance with the regulations, as

amended herein, is authorized immediately. The mandatory compliance

date for these regulations is January 1, 1996.

FOR FURTHER INFORMATION CONTACT: Jennifer Antonielli, Office of

Hazardous Materials Standards, (202) 366-8553, Research and Special

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

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

SUPPLEMENTARY INFORMATION:

I. Background

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

revised 49 CFR 171.14(b) to delay the compliance date for requirements

applicable to RMW and materials infectious only to animals from October

1, 1994, to October 1, 1995. RSPA also delayed the compliance date for

requirements for infectious substances, other than RMW and animal-only

pathogens, from October 1, 1994, to January 1, 1995.

On December 21, 1994, RSPA published a notice of proposed

rulemaking and announced a public meeting under Docket HM-181G (59 FR

65860). In the notice, RSPA proposed to revise the requirements for

infectious substances, including regulated medical waste, which were

adopted in final rules under Docket HM-181 in December 1990 and 1991.

Some of the proposals contained in the NPRM were substantive, such as

the proposal to add an exception from specific packaging and labeling

requirements for RMW if it is prepared in accordance with the

regulations of the Occupational Safety and Health Administration

(OSHA). However, the majority of the changes proposed in the notice

were minor and primarily intended to ease compliance by clarifying the

requirements. Also in the NPRM, RSPA outlined issues for possible

future rulemaking action. The public meeting, which gave interested

persons an opportunity to orally present their comments on the notice,

was held on January 17, 1994, in Washington, DC.

This rule was developed, with the concerns of the health care

industry and medical waste companies in mind, in coordination with

other Federal agencies (e.g., OSHA, Centers for Disease Control and

Prevention (CDC), Food and Drug Administration (FDA), and Environmental

Protection Agency (EPA)) to minimize differences between the Hazardous

Materials Regulations (HMR) and other Federal agency regulations to

ease compliance and eliminate gaps and inadequacies in regulatory

coverage to assure that safety is maintained in transportation. RSPA

will continue to be aware of significant steps being taken by other

Federal agencies to remain cognizant of potential impacts regarding

infectious substances and regulated medical waste prior to their

entering, and in, transportation.

In March 1995, the President directed Federal agencies to review

all agency regulations to eliminate or revise those that are outdated

or in need of reform. RSPA issued a notice on April 4, 1995, under

Docket HM-222 (60 FR 17049), that announced its review of the HMR and

related programs and solicited comments on possible candidates for

elimination or revision to provide clarity or relief from undue

requirements. The provisions contained in this final rule contribute to

meeting the goals of the President's Regulatory Reinvention Initiative.

II. Summary of Comments and Regulatory Changes

RSPA received 41 written comments on the notice of proposed

rulemaking and 4 oral statements at the public meeting. The comments

were submitted by hospitals, pharmaceutical companies, trade

associations, packaging manufacturers, academic institutions,

transporters of medical waste, and private individuals. Commenters

generally supported RSPA's efforts to amend the regulations to

regulating those materials that likely pose a threat in transportation

to ensure the safe transportation of infectious substances and RMW. The

commenters also were pleased that RSPA coordinated with other Federal

agencies in the development of these regulations. Several commenters

stated that, although the proposed amendments narrowed the scope of and

clarified the infectious substance and RMW provisions, they need more

refinement. The commenters predominantly addressed the following

topics: (1) The definition of ``regulated medical waste''; (2)

exclusion of discarded cultures and stocks from the definition of RMW;

(3) a packaging and labeling exception for RMW; (4) a laundry

exception; (5) the definitions of ``biological product'' and

``diagnostic specimen'' and retention of exceptions for these

materials; and (6) aligning the infectious substance provisions with

the international standards. A detailed discussion of the comments and

RSPA's response to them is provided in the following summary.

A. Definition of RMW

RSPA received numerous comments concerning the proposed revision of

the definition of ``regulated medical waste'' (RMW). The majority of

commenters favored RSPA's proposal to limit the definition of RMW to

materials containing an infectious substance. Commenters stated that

RSPA defined RMW rationally, and that this definition would

significantly reduce the amount of medical waste required to be

specially handled without jeopardizing transportation safety. Also,

commenters stated that the proposed definition, which allows shippers

to segregate their waste, is more cost-effective than treating all

waste as RMW. One commenter stated, ``Adoption of a criteria-based

definition, as opposed to a list-based definition, also eliminates the

categories of waste (e.g., unused sharps) that are not hazardous.''

Some commenters raised concerns that the proposed definition of RMW

is impractical and does not account for the fact that RMW is rarely

``known to contain'' an infectious substance. Commenters claimed that,

in order to confirm the presence of an infectious substance, medical

waste would have to undergo cost-prohibitive testing.

[[Page 48781]]

Commenters stated that shippers are forced to make a ``best guess'' as

to whether a medical waste is subject to the HMR, increasing the

potential for undeclared shipments of RMW. In addition, commenters

argued that not all personnel who are responsible for identifying and

packaging the wastes possess the knowledge required to make an accurate

assessment. A commenter claimed that if RMW is not clearly defined and

if guidance is not provided, the volume of waste treated as RMW will

increase and potentially infectious waste will go undeclared in the

solid waste stream. One commenter stated that the definition ``fails to

provide the appropriate guidance to the health care worker responsible

for segregating the regulated medical waste stream and is virtually

impossible to enforce.'' Some commenters recommended that RSPA adopt

``Universal Precautions,'' a method of infection control introduced by

CDC which considers all blood and certain body fluids, whether or not

known to be infectious, are treated as if known to be potentially

infectious. The commenters added that universal precautions are widely

used in the health care industry and, if adopted, would be consistent

with current practices. Some commenters requested that RSPA add

language to the definition of RMW to include those materials that

``may'' or ``are suspected to'' contain an infectious substance to

eliminate some of the guesswork. While some commenters asked RSPA to

expand the definition of RMW, other commenters stated that RSPA's

definition should be narrowed further. One commenter asserted that the

proposed definition is ``inaccurate and inconsistent with science'' and

claimed that essentially all material, including human skin, harbor a

population of microorganisms capable of causing infection in a

susceptible host. The commenter stated, ``[T]he mere presence of an

infectious substance does not result in risk of infection.'' The

commenter claimed that other factors have to be present for infection

to occur such as, the presence of an infectious agent in the

environment, a susceptible host, a portal of entry into the host, and a

sufficient dose of organisms. Some commenters requested that RSPA limit

the definition of RMW to ``waste * * * which contains an infectious

substance and has been causally linked scientifically to human disease

acquisition.'' Another commenter added, ``RSPA's definition, if applied

literally, would result in classifying as regulated medical waste

virtually all of the waste that is generated in the health care

environment.''

RSPA has considered the commenters' suggestions. With regard to

universal precautions, RSPA acknowledges that they are widely used in

the workplace as recommended in CDC guidelines and required under OSHA

regulations contained in 29 CFR 1910.1030. In addition, RSPA agrees

that broadening the scope of RMW to include all waste containing blood

or certain body fluids may ease RMW identification when the exact

constituents of a waste stream are not known. However, RSPA believes

that this concept might result in overregulation if adopted for the

purposes of transportation. At this time, RSPA has no evidence to

support the conclusion that the benefits associated with implementing

universal precautions in transportation outweigh the compliance costs

and regulatory burdens imposed. Therefore, RSPA is not adopting

universal precautions in this rule. RSPA agrees with commenters that

the principles of disease transmission (i.e., presence of an infectious

agent in the environment, susceptible host, portal of entry, sufficient

virulence, and sufficient dose of organisms to cause infection) would

support limiting the definition to those wastes that in fact pose a

hazard in transportation. However, RSPA believes that this definition

would be difficult and, in some cases, impossible to implement since

certain factors, such as the dose of organisms sufficient to cause

infection, are not known by most shippers. Therefore, RSPA is not

adopting the principles of disease transmission for general

applicability. RSPA does not agree with the commenters who requested

that the definition of RMW be revised to mean ``waste * * * which

contains an infectious substance and has been causally linked

scientifically to human disease acquisition.'' While the commenters'

suggestion supports a definition based on scientific considerations,

RSPA believes that the definition is not practical for all shippers. To

determine whether a particular waste has been linked to disease

acquisition requires knowledge of any incidents that have occurred

involving that waste. This information is not available to most

shippers. Therefore, RSPA is not revising the definition as requested.

However, for shippers that possess this information for a given waste

stream, RSPA believes that the information may be used to determine

whether the waste requires special handling as RMW.

In the proposed rule, RSPA attempted to correct an existing

oversight in the HMR with regard to hazard precedence in a case

involving a material that meets the definitions of both Division 6.2

and Class 7. The oversight is found in Sec. 173.2a(c), which prescribes

that a Division 6.2 material that meets the definition of another

hazard class or division is required to be classed as Division 6.2.

RSPA did not intend for Division 6.2 to take precedence over Class 7,

other than for limited quantities of Class 7. To correct the oversight,

RSPA proposed to exclude waste materials meeting the definition of

Class 7 from the definition of RMW but failed to exclude Class 7

materials from the definition of an infectious substance. As proposed,

Class 7 materials, including wastes, containing an infectious substance

would be excepted from the RMW requirements but subject to all

applicable requirements for infectious substances. In this final rule,

RSPA is not adopting the wording ``other than Class 7 (Radioactive)

materials'' in the proposed definition of regulated medical waste. RSPA

is amending Sec. 173.2a(c)(3) to exclude Class 7 (radioactive)

materials, other than limited quantities, which also meet the

definition of Division 6.2 from being classed as Division 6.2. This

will alleviate the need to make changes in Sec. 173.134 for the

definitions of ``regulated medical waste'' and ``infectious

substances.''

Based on the merits of comments received and RSPA's own initiative,

RSPA is revising the definition of ``regulated medical waste'' as

proposed. RMW is defined as ``a waste or reusable material, other than

a culture or stock of an infectious substance, which contains an

infectious substance and is generated in: (1) The diagnosis, treatment

or immunization of human beings or animals; (2) research pertaining to

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

(3) the production or testing of biological products.'' RSPA

understands that it is not always feasible for shippers to verify the

presence of an infectious substance in a waste stream. The wording

``contains an infectious substance'' does not imply that the shipper is

required to verify the presence of an infectious substance by testing

or other means. Shippers may use information that is available to them

(e.g., source of material, patient's medical history, preliminary test

data) to make the most accurate determination possible as to whether or

not a waste meets the definition of RMW under the HMR. If the shipper

does not possess any

[[Page 48782]]

information concerning a waste stream, the shipper may employ universal

precautions, which considers waste containing human blood and certain

human body fluids as infectious. However, as previously stated, it is

not RSPA's intent to require the use of universal precautions. RSPA

strongly encourages the use of segregation and separation practices at

the point of generation. It is our understanding that many entities

currently implement such practices, which help to minimize shipping

costs and ensure that only those wastes that pose a hazard are

regulated.

In the NPRM, RSPA proposed to except certain categories of waste

from the definition of RMW. Included was an exception for waste

generated in animal husbandry or food production. RSPA received a

comment requesting clarification of whether waste generated in animal

research activities also would be excluded from the definition of RMW.

The answer is no. Waste, generated in research activities, that

contains an infectious substance and is offered for transportation or

transported in commerce is regulated as RMW. The definition of RMW, as

adopted in this final rule, includes waste that is generated in the

diagnosis, treatment or immunization of human beings or animals or

research pertaining thereto. RSPA is excluding waste generated in

animal husbandry or food production because regulation of these

activities under the HMR could impose burdens on agricultural and farm

operations disproportionate to benefits likely to be achieved.

Regulation of waste that is generated in animal research activities and

contains an infectious substance is fully within the scope of the HMR.

RSPA clarified in the notice that the exceptions applicable to

biological products and diagnostic specimens do not apply to materials

which have become wastes. One commenter recommended that RSPA limit the

definition of RMW to include only those discarded (waste) biological

products and diagnostic specimens that have been confirmed to contain

an infectious substance by a screening test required or recommended by

the Food and Drug Administration. RSPA understands that not all

biological products or diagnostic specimens are tested before shipment

for treatment or disposal. Therefore, RSPA is not adopting a

requirement to limit the application of the definition of RMW as

requested by the commenter. If the discarded biological product or

diagnostic specimen contains an infectious substance and has not been

treated to eliminate the hazard, it must be shipped as RMW.

Another commenter requested that RSPA clarify that it is the

responsibility of the shipper, and not the carrier, to properly class a

material. The commenter stated that the waste generator is in the best

position to determine whether the waste is a regulated medical waste,

an infectious substance, or not regulated. In accordance with

Sec. 173.22, a person who offers a hazardous material for

transportation in commerce is responsible for properly classing the

material in accordance with the hazard class definitions of 49 CFR Part

173. Because this requirement already appears in the HMR, RSPA is not

adding an additional requirement. Also, RSPA notes that some carriers

assume responsibilities of the waste generator through contractual

arrangement.

B. Discarded Cultures and Stocks

Several commenters agreed with RSPA's proposal to exclude waste

cultures and stocks from the definition of RMW and subject them to

requirements applicable to non-waste cultures and stocks of infectious

substances. Commenters stated that cultures and stocks contain a high

concentration of microorganisms that have the potential to cause

disease in humans or animals and require special handling. In addition,

the commenters claimed that cultures and stocks typically are treated

on-site by autoclave or other treatment method. Therefore, commenters

affirmed that RSPA would not be imposing an unreasonable burden on

shippers by requiring the infectious substance requirements for

untreated cultures and stocks. However, other commenters believed that

discarded cultures and stocks should be considered as RMW. According to

one commenter, most laboratories and hospitals sterilize cultures and

stocks before transporting them off-site; therefore, the packaging for

RMW should be adequate for the hazards posed by these materials.

Another commenter asserted that waste cultures and stocks should not be

treated differently from RMW but did not substantiate its claim.

In the notice, RSPA clarified that if a material has been

sterilized or treated to eliminate its hazard as an infectious

substance, it is not subject to the HMR, provided it does not meet the

definition of any other hazard class. Therefore, cultures and stocks

that have been autoclaved, incinerated, or treated by other effective

means are not subject to the HMR, provided they do not meet the

definition of any other hazard class. In view of the comments, RSPA is

excluding untreated cultures and stocks intended for disposal from the

definition of RMW. These materials are included under the definition of

infectious substances.

C. RMW Packaging and Labeling Exception

In the notice, RSPA proposed to except RMW from the specific

packaging requirements of Sec. 173.197 and labeling requirements of

Subpart E of Part 172 if packaged in rigid non-bulk packagings

conforming to the general packaging requirements of Secs. 173.24 and

173.24a and OSHA packaging and marking requirements in 29 CFR

1910.1030. RSPA proposed to limit the exception to RMW that is offered

for transportation or transported by private or contract carrier. The

majority of the commenters addressing this subject supported the

proposed exception. Some commenters indicated that the exception will

allow generators of RMW to maintain their current practices. One

commenter recommended that RSPA limit the application of the RMW

exception to contract carriers registered with the Federal Highway

Administration (FHWA) and vehicles operated by drivers holding a

Commercial Drivers License (CDL). If the exception is not modified, the

commenter stated that the exception ``would be abused by any number of

carriers who may not be familiar or in compliance with DOT Motor

Carrier Safety Regulations or familiar with industry standards and

practices.''

RSPA disagrees with this commenter. Familiarity with the Federal

Motor Carrier Safety Regulations (FMCSR; 49 CFR Parts 300-399) and

possession of a CDL would not necessarily enhance a carrier's or

driver's specialized knowledge of medical waste requirements. In

addition, the FMCSR and CDL requirements are only applicable to highway

motor carriers and drivers. Because the HMR relate to all modes of

transportation, the commenter's suggestion to limit the applicability

of the exception to RMW transported by contract carriers registered

under the FMCSR and drivers with CDLs is not adopted.

Another commenter asserted that the exception allowing OSHA

packaging and marking does not sufficiently communicate the nature and

risk of the package to the carrier. The commenter requested that RSPA

require packages containing RMW to display the name, address, and

telephone number of the generator and the date of generation. The

commenter stated that in the event of a needle stick injury, OSHA

requires the employer/carrier to ascertain the route of exposure.

According to the

[[Page 48783]]

commenter, some carriers pick up RMW from several generators on a given

route and it is impossible to determine the route of exposure if the

source of the package is unknown.

In the NPRM, RSPA proposed to except RMW from specific packaging

and labeling requirements, but not from marking or other hazard

communication requirements. Section 172.301(d) requires that non-bulk

packages of hazardous material be marked with the name and address of

the consignee or consignor, unless the package is transported by

highway and is not being transferred from one carrier to another; or is

part of a carload, truckload, or freight container load, and the entire

contents of the rail car, truck or freight container are shipped from

one consignor to one consignee. In cases which the name and address of

the consignor or consignee are not required on package markings, a

carrier may, by contractual arrangement, have the waste generator mark

its name and address on packages or use other means to keep track of

where packages originate. RSPA does not believe there is a need for a

regulatory requirement for the consignor's name and address to appear

on a package in all instances. Therefore, the commenter's

recommendation is not adopted.

In this final rule, RSPA is authorizing non-bulk, non-specification

packagings for RMW under the conditions specified in the NPRM. RSPA

intends to monitor incident reports for these shipments to ensure that

the packaging and handling requirements achieve an acceptable level of

safety. If they do not, RSPA will propose adjustments in future

rulemaking action.

D. Exception for Laundry and Medical Equipment

To relieve the burden of compliance with both the HMR and OSHA

regulations, RSPA proposed to except from the HMR contaminated laundry

and medical equipment that conforms to OSHA regulations at 29 CFR

1910.1030. Of the few commenters addressing this issue, most supported

RSPA's proposed exception. However, one commenter contended that

laundry should not be regulated differently than RMW. The commenter

reported that although OSHA requires sharps to be separated from other

RMW, in reality, sharps are occasionally left in laundry which poses a

hazard to personnel handling the laundry. The commenter stated, ``it is

appropriate to include laundry in a RMW category because laundry, while

not itself a waste, does contain RMW.''

RSPA agrees with the commenter that laundry and disposable garments

share similar characteristics. However, laundry and disposable

materials are handled differently from the point of generation to

decontamination or disposal. Typically, laundry is segregated from

waste materials at the point of generation and specially handled and

reprocessed by employees dealing exclusively with laundry. Conversely,

disposable garments and the like are combined with other non-sharp

wastes at the point of generation and managed as medical waste,

regulated or non-regulated. RSPA believes that the OSHA requirements

applicable to laundry and medical equipment provide an adequate level

of safety in transportation and it is unreasonable and impractical to

require RMW packaging and hazard communication for laundry and medical

equipment that are intended for reuse. OSHA prescribes that

contaminated laundry shall be placed and transported in bags or

containers labeled or color-coded in accordance with 29 CFR

1910.1030(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. See 29 CFR

1910.1030(d)(4)(iv). OSHA prescribes that medical equipment, including

equipment used for diagnosis, research, or treatment, shall be

decontaminated, to the maximum extent practicable, before

transportation. If decontamination is impractical, the equipment should

be labeled with the ``BIOHAZARD'' label. See 29 CFR

1910.1030(d)(2)(xiv). In this final rule, RSPA is adopting the

exception for laundry and medical equipment as proposed in the NPRM.

E. Biological Products and Diagnostic Specimens

In an attempt to clarify the scope of the HMR, RSPA proposed to

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

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

substance. However, commenters' responses suggest that the proposal may

have added confusion. Some commenters contended that it was illogical

for RSPA to amend the definitions of biological products and diagnostic

specimens to limit them to materials that contain an infectious

substance, but continue to except them from the HMR. Commenters

asserted that defining a ``diagnostic specimen'' as ``a material that

contains an infectious substance being shipped for purposes of

diagnosis'' is contradictory. One commenter argued that the primary

reason a diagnostic specimen is shipped is to determine, through

testing, whether or not it contains an infectious substance. Another

commenter requested that RSPA keep its previous definitions of

diagnostic specimen and biological product because they are consistent

with other Federal regulations. RSPA agrees with the commenters and is

not amending the definitions of ``biological product'' and ``diagnostic

specimen'' as proposed in the notice.

Several commenters also opposed retaining the exceptions for

biological products and diagnostic specimens, asserting that

insufficient protection will be afforded to transport workers and the

public if biological products and diagnostic specimens, especially

those that are known to contain an infectious substance, are excepted

from regulation. One commenter stated that these exceptions effectively

eliminate Division 6.2 materials from the HMR.

RSPA agrees with commenters that some level of regulation may be

needed for biological products and diagnostic specimens under the HMR

to ensure safety, but RSPA is not imposing any requirements for these

materials in this rule. Under the current requirements, a biological

product or diagnostic specimen that contains an infectious substance is

excepted from the HMR, unless the biological product or diagnostic

specimen is being discarded, in which case it would be regulated as

RMW. RSPA anticipates proposing to delete the exceptions for biological

products and diagnostic specimens and impose appropriate requirements

for these materials, if justified after evaluation of associated

benefits and costs, in future rulemaking action.

F. Extension of Compliance Date

In the notice, RSPA proposed to extend the compliance date for the

requirements applicable to RMW and infectious substances affecting

animals only, from October 1, 1995, to January 1, 1996. Some commenters

supported having additional time to come into compliance with the

requirements for RMW and infectious substances affecting animals only.

The commenters stated that an extension will also allow RSPA time to

issue its final rule and provide regulated industry sufficient time to

comply with the new changes. However, other commenters expressed

concern in regard to RSPA's proposal to

[[Page 48784]]

extend the compliance date from October 1, 1995, to January 1, 1996.

These commenters suggested that the compliance date be delayed for an

indefinite period of time until the final rule has been issued and RSPA

has resolved all of the issues.

RSPA disagrees with these latter comments and believes there is a

need to put these requirements in place as quickly as practicable, to

help eliminate ongoing confusion over what regulatory requirements

apply. Also, RSPA believes that implementation on January 1, 1996 is a

reasonable extension of time. Therefore, the proposal is adopted.

Because these amendments extend the compliance date from October 1,

1995, to January 1, 1996, they are effective without the customary 30-

day delay following publication. This will allow the changes to appear

in the next revision of 49 CFR.

G. Air Transportation

RSPA received several comments concerning the proposal to add

Special Provisions ``A13'' and ``A14'' to allow certain quantities of

regulated medical waste aboard aircraft. Most of the commenters

supported removal of the prohibition to transport RMW by air. Some

commenters questioned RSPA's rationale for the quantities selected in

the proposed rule. One commenter expressed concern about allowing 12

liters of RMW by air without prescribing higher integrity packaging

requirements. Some commenters stated that RMW should not be restricted

to any quantity limits since the International Civil Aviation

Organization (ICAO) Technical Instructions do not impose quantity

limits for RMW.

RSPA selected the proposed quantity limits in the NPRM based on

comments received on the March 3, 1993 advance notice of proposed

rulemaking and for consistency with quantity limits under U.S. Postal

Service regulations. Therefore, RSPA is adding these special

provisions, as proposed, to facilitate air transportation of RMW.

H. Animal Pathogens

In the NPRM, RSPA requested comments concerning HMR regulation of

infectious substances affecting animals only. RSPA received limited

comments on this issue. One commenter stated that RSPA does not have

the authority to regulate infectious substances affecting animals only

and that the likelihood of an incident involving an animal exposed to

an infectious substance as a result of a release in transportation is

small.

RSPA agrees with the commenter that the probability of an incident

occurring involving animals exposed to animal pathogens during

transportation might be low. However, the potential exists and RSPA is

aware of at least one such incident. Under the Federal hazardous

material transportation law, RSPA is required to promulgate regulations

for the transport of materials that may pose an unreasonable risk to

health, safety and property. Protection of animals is encompassed

within this jurisdiction. In addition, RSPA has determined that the

costs incurred by regulation of these materials is minimal compared to

the benefits acquired. In regard to other applicable Federal

regulations, RSPA has examined the Department of Agriculture's

regulations concerning animal pathogens contained in 9 CFR parts 1-199

and determined that they do not adequately address transportation

concerns with regard to communication of hazard, provision of emergency

response information, and packaging. Therefore, RSPA is regulating

infectious substances affecting animals only, as proposed.

I. Other Issues

Two commenters asked RSPA to clarify its preemption authority in

the preamble. The commenters suggested that States may impose

requirements on the transportation of medical waste that go beyond

those imposed by this rule. In particular, the commenters noted, States

may define infectious substances and medical waste more broadly, to

include categories of materials not regulated under the HMR. One

commenter stated: ``a decision by RSPA not to regulate (e.g., a

decision to exclude certain materials from the definition of regulated

medical waste), should carry as much preemptive effect as a decision to

regulate.''

As provided in Subpart C to Part 107, any law, regulation, order,

ruling, provision or other requirement of a State, political

subdivision, or Indian tribe that concerns a ``covered subject,'' as

defined at Sec. 107.202(a), and that is not substantively the same as

any provision of the Federal hazmat law or any regulation issued

thereunder, is preempted. Covered subjects include classification of,

and specification of packaging and hazard communication requirements

for the transportation of, hazardous materials. Non-Federal

requirements pertaining to the transportation of infectious substances

that concern a covered subject accordingly are subject to preemption

under this standard.

The HMR do not, however, preempt non-Federal requirements imposed

on the transportation of materials that are not hazardous materials as

defined in the HMR. One exception to this general principle, however,

would be where a non-Federal law or regulation requires a method of

hazard communication for non-hazardous materials sufficiently similar

to that prescribed by the HMR for a hazardous material that the

regulation is ``tantamount to the creation of an additional class of

hazardous materials with its own marking requirements.'' 59 FR 6186,

6192 (Feb. 9, 1994) (preemption determination PD-6). Short of this type

of circumstance (de facto classification of materials as hazardous

materials), however, State, local and tribal regulation of materials

that are not hazardous materials is not subject to preemption by the

Federal hazmat law. RSPA has proposed to extend application of the HMR

to all intrastate transportation in a notice of proposed rulemaking

published on July 9, 1993, under Docket HM-200 (58 FR 36920). Further

action under that docket is pending.

RSPA received comments requesting that RSPA require treated medical

waste to be physically altered until it is unrecognizable so that it

can be readily identified as non-regulated. Although this practice may

be required under certain State medical waste regulatory programs, RSPA

is not adopting it at this time because it is beyond the scope of this

rule.

In the NPRM, RSPA invited comments on possible adoption of a

vehicle placarding requirement for Division 6.2 materials based on a

petition for reconsideration (P-1080). Due to inadequate information,

RSPA did not propose to adopt such a requirement in the NPRM but stated

that it is under consideration for future rulemaking. Several

commenters urged RSPA to clarify that RMW is not and will not be

subject to placarding requirements. The commenters asserted that

bloodmobiles carrying bulk blood intended for disposal would be subject

to CDL and drug and alcohol regulations if placarding is required. RSPA

is not adopting a placarding requirement, as requested by the

petitioner, or vehicle marking requirement for Division 6.2 materials

in this rule. However, RSPA is aware that several States have differing

marking requirements for medical wastes. It may be appropriate, for

purposes of national uniformity and minimum communication, to propose

in future rulemaking a special marking, other than a placard, to

identify the presence of these materials in a vehicle.

In the preamble of the notice, RSPA stated that this rulemaking

action was limited to amendments that could be accomplished in the

short term and that

[[Page 48785]]

more substantive issues would be addressed in future rulemaking. Some

commenters contended that dividing the problematic issues into two or

more rulemakings would be confusing. These commenters urged RSPA to

make all necessary adjustments to the regulations in one rule.

RSPA believes that certain changes to the requirements for RMW

adopted under Docket HM-181 on December 20, 1991, are necessary, before

they become mandatory, to eliminate confusion and facilitate

transportation of RMW. However, in order to make the necessary changes

to the RMW requirements and publish the rule before October 1, 1995,

RSPA had to limit the amendments in this rule to minor, short-term

adjustments.

RSPA received comments requesting that bulk packaging standards for

RMW be incorporated into the HMR. Currently, their use is authorized

under the provisions of a number of exemptions. RSPA stated in the

preamble of the notice that it anticipates proposing to convert the

provisions of some or all of these exemptions into regulations of

general applicability. RSPA intends to address bulk packagings for RMW

in a future rulemaking.

Several commenters encouraged RSPA to align the classification,

hazard communication, and packaging requirements for Division 6.2

materials in the HMR with the most recent edition of the UN

Recommendations and ICAO Technical Instructions. Specifically, some

commenters recommended that RSPA require infectious substances

packagings to be UN marked and certified for consistency with

international standards.

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 generally are

consistent with the United Nations Recommendations on the Transport of

Dangerous Goods (UN Recommendations), although there are 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,

biological products and diagnostic specimens, and new shipping

descriptions and marking requirements for non-bulk packagings based on

the UN Recommendations. Both through rulemaking action and in working

with other Federal agencies, RSPA anticipates advocating standards

based on UN Recommendations.

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. Moreover, as new information becomes available,

RSPA may propose to make adjustments to the requirements for Division

6.2 materials in future rulemaking as necessary.

III. Section-by-Section

Part 171

Section 171.14. RSPA is amending Sec. 171.14(b)(7) to change the

compliance date from October 1, 1995, to January 1, 1996, to give

industry additional time to comply with the changes adopted in this

final rule.

Part 172

Section 172.101. RSPA is amending Column (8A) of the Hazardous

Materials Table for the entries, ``Infectious substances, affecting

humans'', ``Infectious substances, affecting animals'' and ``Regulated

medical waste'', to reflect the correct section references. RSPA is

revising the identification number in Column 4 for ``Regulated medical

waste'' from ``NA9275'' to ``UN3291.'' RSPA also is adding two special

provisions, ``A13'' and ``A14,'' in Column 7 for ``Regulated medical

waste.''

Section 172.102. RSPA is adding Special Provisions ``A13'' and

``A14'' to permit transportation of RMW by aircraft as proposed.

Special Provision A13 allows the transportation of sharps aboard

passenger and cargo-carrying aircraft in quantities not exceeding 16

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

milliliters (1.7 ounces) for each inner packaging. Special Provision

A14 permits the transportation of RMW by aircraft in quantities of not

more than 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. These provisions are necessary to

facilitate transportation of RMW in rural areas and ensure that

shippers of used sharps do not encounter unnecessary delays or

frustration of shipments.

Part 173

Section 173.2a. RSPA is amending Sec. 173.2a(c)(3) to provide that

Division 6.2 materials do not include those meeting the criteria for

Class 7 (radioactive) materials, other than limited quantities. RSPA

did not intend for Division 6.2 to take precedence over Class 7

materials.

Section 173.134. RSPA is revising Sec. 173.134 for clarity and to

provide relief from overly restrictive requirements for certain

shipments of RMW. RSPA is not amending the definitions of ``biological

product'' and ``diagnostic specimen'' as proposed. RSPA believes, based

on commenters' observations, that clarifying RSPA's intent in the

preamble is likely to be more effective than revising the definitions.

Based on comments received, RSPA is relocating the definition of

``regulated medical waste'' and its exceptions from Appendix G of Part

173 to Sec. 173.134 to ease compliance with the HMR. In addition, RSPA

is relocating the exceptions for biological products and diagnostic

specimens from Sec. 173.196 to Sec. 173.134. RSPA is adding an

exception for material that once contained an infectious substance but

has been treated to eliminate the hazard. In addition, RSPA is

clarifying that the following materials are not considered RMW: (1) EPA

hazardous wastes; (2) waste derived from households; (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 initiative, RSPA is revising

the definition of RMW by adopting a criteria-based definition as

opposed to a list-based definition, that is, removing the categories in

Appendix G and replacing them with a general definition. Regulated

medical waste is defined as a waste or reusable material, other than a

culture or stock of an infectious substance, that 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.

Also in Sec. 173.134, RSPA is adding an exception for RMW that is

packaged in a rigid, non-bulk packaging that meets the general

packaging requirements of Secs. 173.24 and 173.24a, meets packaging and

marking requirements in 29 CFR 1910.1030, and is offered for

transportation or transported by private or contract carrier.

[[Page 48786]]

In paragraph (c) of this section, RSPA is clarifying that Division

6.2 materials other than RMW are not assigned a packing group. RMW is

assigned to a Packing Group II performance level.

Part 178

Section 178.609. RSPA is adding a new paragraph (i) to clarify that

packagings for infectious substances conforming to this section are not

required to be marked and certified in accordance with Sec. 178.503.

IV. Regulatory Analyses and Notices

A. Executive Order 12866 and DOT Regulatory Policies and Procedures

This final 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 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 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 final rule concerns the classification, packaging, labeling,

and handling of hazardous material, among other covered subjects.

This rule preempts 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. The

effective date of Federal preemption for the requirements in this final

rule that concern covered subjects is January 1, 1996.

C. Regulatory Flexibility Act

This final rule revises requirements for infectious substances and

regulated medical waste contained in the HMR by narrowing the scope of

these provisions. The changes in this rule provide relief to shippers,

carriers of infectious substances and regulated medical waste, and some

packaging manufacturers. Although the changes will affect many small

entities, such as medical clinics, we expect the economic impact on

each of them to be minimal. Therefore, I certify that this rule will

not have a significant economic impact on a substantial number of small

entities.

D. Paperwork Reduction Act

There are no new information collection requirements in this final

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 are amended as follows:

PART 171--GENERAL INFORMATION, REGULATIONS, AND DEFINITIONS

1. The authority citation for part 171 continues to read as

follows:

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

2. In Sec. 171.8, the following definition is added in appropriate

alphabetical order to read as follows:

Sec. 171.8 Definitions and abbreviations.

* * * * *

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

* * * * *

Sec. 171.14 [Amended]

3. In Sec. 171.14, as revised at 59 FR 67406, effective October 1,

1995, in paragraph (a)(1)(ii), in the heading, the wording ``October 1,

1995'' is revised to read ``January 1, 1996'' and, in the regulatory

text, the wording ``October 1, 1995'' is revised to read ``January 1,

1996''.

Sec. 171.15 [Amended]

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

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

substances (etiologic agents)''.

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

MATERIALS COMMUNICATIONS, EMERGENCY RESPONSE INFORMATION, AND

TRAINING REQUIREMENTS

5. The authority citation for part 172 continues to read as

follows:

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

Sec. 172.101 [Amended]

6. In Sec. 172.101, in the Hazardous Materials Table, as revised at

59 FR 67409, effective October 1, 1995, the following changes are made:

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

only'', in Column (8A), ``196'' is removed and replaced with ``134''.

[[Page 48787]]

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

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

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

identification number ``NA9275'' is removed and replaced with

``UN3291''; in Column (7), ``A13, A14'' is added; and in Column (8A),

``197'' is removed and replaced with ``134''.

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

A14 are 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 only 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

8. The authority citation for part 173 continues to read as

follows:

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

9. In Sec. 173.2a, paragraph (c)(3) is revised to read as follows:

Sec. 173.2a Classification of a material having more than one hazard.

* * * * *

(c) * * *

(3) A Division 6.2 (infectious substance) material that also meets

the definition of another hazard class or division, other than Class 7,

or that also is a limited quantity Class 7 material, shall be classed

as Division 6.2;

* * * * *

10. Section 173.134 is 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 constitute Division 6.2 are defined as

follows:

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

toxin, that 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

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

components, tissue, and tissue fluids, being shipped for purposes of

diagnosis.

(3) A biological product means a material that 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 culture or stock of an infectious substance, that 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 that 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, that previously contained an

infectious substance and has been treated by steam sterilization,

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

longer poses the hazard of an infectious substance;

(v) Any waste material, including garbage, trash and sanitary waste

in septic tanks, derived from households, including but not limited to

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 of 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 and 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]

11. Appendix G to part 173 is removed.

PART 178--SPECIFICATIONS FOR PACKAGINGS

12. The authority citation for part 178 continues to read as

follows:

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

13. In Sec. 178.609, paragraph (i) is 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 September 14, 1995, under authority

delegated in 49 CFR part 1.

D.K. Sharma,

Administrator, Research and Special Programs Administration.

[FR Doc. 95-23243 Filed 9-15-95; 8:45 am]

BILLING CODE 4910-60-P