[Federal Register: January 22, 2001 (Volume 66, Number 14)]

[Proposed Rules]

[Page 6941-6962]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr22ja01-55]

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Part VI

Department of Transportation

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Research and Special Programs Administration

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49 CFR Parts 171, 172, 173, 177 and 178

Hazardous Materials: Revision to Standards for Infectious Substances

and Genetically Modified Micro-Organisms; Proposed Rule

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DEPARTMENT OF TRANSPORTATION

Research and Special Programs Administration

49 CFR Parts 171, 172, 173, 177, and 178

[Docket No. RSPA-98-3971 (HM-226)]

RIN 2137-AD13

Hazardous Materials: Revision to Standards for Infectious

Substances and Genetically Modified Micro-Organisms

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

ACTION: Notice of proposed rulemaking.

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SUMMARY: RSPA is proposing to revise transportation requirements for

infectious substances, including regulated medical waste, by adopting

defining criteria and packaging requirements for infectious substances

and genetically modified micro-organisms that are consistent with

international standards; revising the current broad exceptions for

diagnostic specimens and biological products; and authorizing bulk

packaging options for regulated medical waste consistent with

requirements in international standards and DOT exemptions. These

proposals are intended to assure an acceptable level of safety for the

transportation of infectious substances and to facilitate domestic and

international transportation.

DATES: Comments. Submit comments by April 23, 2001. To the extent

possible, we will consider comments received after this date in making

our decision on a final rule.

ADDRESSES: Submit comments to the Dockets Management System, U.S.

Department of Transportation, Room PL-401, 400 Seventh Street, SW.,

Washington, DC 20590-0001. Comments should identify Docket Number RSPA-

98-3971 (HM-226) and be submitted in two copies. If you wish to receive

confirmation of receipt of your written comments, include a self-

addressed, stamped postcard. You may also submit comments by e-mail by

accessing the Dockets Management System web site at ``http://

dms.dot.gov/'' and following the instructions for submitting a document

electronically.

The Dockets Management System is located on the Plaza level of the

Nassif Building at the Department of Transportation at the above

address. You can review public dockets there between the hours of 9

a.m. and 5 p.m., Monday through Friday, except federal holidays. You

can also review comments on-line at the DOT Dockets Management System

web site at

``http://dms.dot.gov/.''

FOR FURTHER INFORMATION CONTACT: Eileen Edmonson or Susan Gorsky (202)

366-8553, Office of Hazardous Materials Standards, Research and Special

Programs Administration.

SUPPLEMENTARY INFORMATION:

List of Topics

I. Background

II. Need for New Regulations

III. Summary of Proposals in NPRM

A. Classification Criteria for Infectious Substances

B. Packaging Requirements for Infectious Substances

C. Exceptions for Domestic Shipments of Infectious Substances

D. Diagnostic Specimens

E. Biological Products

F. Genetically Modified Micro-Organisms

G. Regulated Medical Waste

H. Used Health Care Products

I. Hazard Communication

J. Petition for Rulemaking

IV. Section-by-Section Review

V. Regulations of Other Agencies

A. Centers for Disease Control and Prevention

B. Occupational Safety and Health Administration

C. Food and Drug Administration

D. U.S. Department of Agriculture

E. Actions to Assure Regulatory Consistency

VI. Regulatory Analyses and Notices

A. Executive Order 12866 and DOT Regulatory Policies and

Procedures

B. Executive Order 13132

C. Executive Order 13084

D. Regulatory Flexibility Act

E. Paperwork Reduction Act

F. Regulation Identifier Number (RIN)

G. Unfunded Mandates Reform Act

H. Environmental Assessment

I. Background

On September 2, 1998, the Research and Special Programs

Administration (RSPA, we) published an advance notice of proposed

rulemaking (ANPRM) on revisions to the current requirements in the

Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable

to the transportation of infectious substances, Division 6.2, including

regulated medical waste (63 FR 46844). We asked a variety of questions

concerning classification criteria, hazard communication, and packaging

requirements for infectious substances consistent with international

standards; revisions to the current exceptions in the HMR for

diagnostic specimens and biological products; and additional packaging

requirements for regulated medical waste (RMW).

In addition, we conducted an electronic public meeting on the

Internet from September 14-16, 1998, to facilitate public comment on

the issues discussed in the ANPRM. For the Internet meeting, we posted

the questions listed in the ANPRM and additional questions to encourage

commenters to provide specific quantitative information relative to the

transportation of infectious substances.

We received 89 comments in response to the ANPRM and the Internet

meeting. Several commenters submitted more than one response. Most

comments came from industry associations, colleges and universities,

laboratories, and medical waste transporters. Comments were also

submitted by state veterinary laboratories, state departments of

agriculture, health insurance companies, a blood supplier, equipment

suppliers, private citizens, a fire department, a union, and the U.S.

Department of Agriculture.

II. Need for New Regulations

Many commenters question the need for increased regulation of

infectious substances. They cite their experience with transporting

these materials to support their view that there is little or no safety

risk associated with such transportation and, thus, no justification

for the changes proposed in the ANPRM. Commenters further assert that

the proposed packaging and hazard communication requirements will

impose significant transportation costs that are not justified by the

safety risks involved with shipping infectious substances.

We do not agree that there is little risk associated with the

transportation of infectious substances. RSPA's Hazardous Materials

Information System (HMIS) includes reports of carriers discovering

leaking, unlabeled packages containing blood and other potentially

infectious material and of packages containing infectious materials

being damaged in handling and releasing their contents. The Centers for

Disease Control receives about 400 reports each year from carriers who

detect leakage or other damage to packages of infectious substances.

Releases of infectious substances in transportation present the

possibility of exposure for transportation workers and the general

public and can result in costly shipping delays and clean-up efforts.

Further, as a result of a provision in the accident reporting

requirements in the HMR and the wording of the INFECTIOUS SUBSTANCE

label, many releases of infectious substances are reported to CDC

rather than to RSPA. Although the HMR require incident information

reported to CDC also to be

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reported to RSPA in a written incident report, carriers do not

routinely do so. This has resulted in under-reporting of these

incidents in RSPA's HMIS data base.

Over the last several years, individuals and companies commenting

on infectious substances rulemakings or on their own initiative have

reported information concerning infectious substance releases. These

reports include blood pouring from roll-offs and freight containers

transporting regulated medical waste (RMW), the disposal of HIV-

contaminated blood in municipal waste cans, overturned vehicles that

have released diagnostic specimens on highways, ruptured packages

containing diagnostic specimens being transported by aircraft, releases

of treatment-resistant diseases from inadequate packaging, and used

sharps that puncture inner packagings.

Because of these reports and our own findings, we believe that the

current regulatory requirements applicable to transportation of

Division 6.2 materials should be strengthened. Accordingly, in this

NPRM, we are proposing the following changes to the HMR:

Adoption of new classification criteria for infectious

substances based on defining criteria developed by the World Health

Organization and consistent with standards contained in the United

Nations Recommendations on the Transport of Dangerous Goods and the

International Civil Aviation Organization's Technical Instructions for

the Safe Transport of Dangerous Goods by Air.

Revision of current packaging requirements for Division

6.2 materials for consistency with international performance standards.

Elimination of the current exception from requirements in

the HMR for diagnostic specimens to impose certain packaging and hazard

communication requirements. Diagnostic specimens transported in

dedicated motor vehicles by private or contract carriers would continue

to be excepted from most requirements in the HMR.

Modification of the current exception from requirements in

the HMR for biological products, limiting the exception to biological

products licensed for use under current regulations of the Food and

Drug Administration or U.S. Department of Agriculture.

New transportation requirements for the transportation of

genetically modified micro-organisms consistent with international

requirements.

New bulk packaging options for the transportation of RMW,

based on current exemption provisions.

New hazard communication requirements for shipments of

Division 6.2 materials.

III. Summary of Proposals in NPRM

A. Classification Criteria for Infectious Substances

In the ANPRM, we indicated that we are considering revising the

classification criteria for infectious substances consistent with the

United Nations Recommendations on the Transport of Dangerous Goods (UN

Recommendations) and the International Civil Aviation Organization's

Technical Instructions for the Safe Transport of Dangerous Goods by Air

(ICAO Technical Instructions). In particular, we said we are

considering adopting the risk groups and defining criteria developed by

the World Health Organization (WHO) for Division 6.2 materials.

Commenters who support international harmonization of the

classification criteria for infectious substances note that the

proposal in the ANPRM would facilitate shipment of infectious

substances in international commerce and by aircraft. Commenters

opposed to the proposal are concerned about the possible

misinterpretation and misapplication of the WHO risk group criteria.

These commenters believe that the WHO risk group definitions are poorly

worded and subject to broad interpretation and, as a result, assigning

materials to risk group categories may be difficult or impossible.

As we stated in the ANPRM, the hazards posed by Division 6.2

materials vary greatly depending on the pathogenicity of the organism,

the mode and relative ease of transmission, and other factors (63 FR

46845). It should be noted that determining if a material is infectious

has always included subjective analysis in the absence of actual

testing. Classifying these materials based on the level of risk and

applying transportation requirements commensurate with that risk should

ensure an adequate level of safety without imposing an undue burden on

the regulated community. International harmonization of transportation

standards also facilitates foreign trade and helps U.S. companies

compete in the global economy. Most passenger and cargo air carriers

currently require shipments of Division 6.2 materials to conform to the

international standards.

Thus, in this NPRM, we are proposing to define Division 6.2

materials using the WHO risk group criteria. The proposal would require

Division 6.2 materials to be assigned to risk groups based on the

degree to which they cause injury through disease, with Risk Group 1

presenting the lowest risk and Risk Group 4 presenting the highest

risk. Assignment to a risk group would be based on the known medical

history of the patient or animal, endemic local conditions, symptoms of

the patient or animal, or professional judgement concerning the

individual circumstances of the patient or animal. Division 6.2

materials assigned to Risk Group 1 would be excepted from requirements

in the HMR.

Commenters to the ANPRM are concerned that updated lists indicating

risk group assignments for specific pathogens are difficult to obtain.

We are aware of several organizations that maintain such lists. The

American Biological Safety Association (ABSA) lists bacteria, fungi,

viruses, and parasites according to their assigned risk groups. These

lists can be found on-line at the ABSA web site (http://www.absa.org/).

In addition, the ABSA web site includes links to risk group listings

from Canada (in Health Canada's Laboratory Biosafety Guidelines at

http://www.hc-sc.gc.ca/hpb/lcdc/biosafty/docs/index.html) and to

Belguim's Biosafety Server (http://biosafety.ihe.be/), which includes

information on European regulation of infectious substances. The ABSA

web site also includes information on the regulation of infectious

substances in Australia, Brazil, Japan, and New Zealand at http://

biosafety.ihe.be/Menu/BiosWorld.html. We plan to work with WHO and CDC

to assure that updated guidance for determining the risk groups for

specific materials is easily available.

B. Packaging Requirements for Infectious Substances

The HMR currently require an infectious substance to be packaged in

a triple packaging that includes a water-tight primary receptacle, a

water-tight secondary packaging, and an outer packaging. The primary

receptacle or secondary packaging must be capable of withstanding,

without leakage, an internal pressure that produces a pressure

differential of not less than 95kPa (0.95 bar, 14 psi) and temperatures

in the range of -40 deg.C to +55 deg.C (-40 deg.F to +131 deg.F).

The triple packaging must be capable of passing the performance tests

specified in Sec. 178.609.

In this NPRM, we propose to incorporate several changes to the

packaging requirements and performance tests to make them

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consistent with the UN Recommendations and ICAO Technical Instructions.

For example, we propose to require manufacturers to mark packagings

represented as conforming to the specifications for infectious

substances packagings in the HMR consistent with UN marking

requirements. In addition, we propose to require manufacturers to

retain packaging design qualification records and to retest packagings

every 24 months. Further, we propose to replace the current requirement

for a water immersion test with a water-spray test that simulates

exposure to rainfall, as required by the ICAO Technical Instructions.

Similarly, we propose to incorporate the selective testing provisions

in the UN Recommendations and ICAO Technical Instructions to allow

variations in the primary receptacles within the secondary packaging

without further testing of the completed package if an equivalent level

of performance is maintained.

C. Exceptions for Domestic Shipments of Infectious Substances

In the September 1998 ANPRM, we noted that we are considering

several exceptions from HMR requirements for domestic shipments of

infectious substances by motor carrier. For example, the HMR include

exceptions from most requirements of the HMR for hazardous materials

transported as materials of trade. Materials of trade include hazardous

materials carried by private motor carriers engaged in a principal

business other than transportation, such as lawn care, plumbing,

welding, and door-to-door sale of consumer goods. The materials of

trade exception limits the maximum gross weight of materials of trade

that may be carried on a motor vehicle and includes minimum packaging

and hazard communication requirements.

In the ANPRM, we invited comments on expanding the materials of

trade exception to permit certain biological products, diagnostic

specimens, and RMW to be transported by private carriage as materials

of trade. Commenters opposed to a materials of trade exception for

infectious substances assert that such an exception would not provide

an adequate level of safety for transporting infectious materials.

Commenters who support a materials of trade exception note that it

would reduce potential transportation costs, particularly if we remove

the current exceptions in the HMR for diagnostic specimens and

biological products.

In this NPRM, we are proposing to expand the materials of trade

exceptions currently permitted under Sec. 173.6 of the HMR to include

certain biological products, diagnostic specimens, and RMW, including

cultures and stocks. As proposed, this exception does not apply to

materials known to contain or suspected of containing infectious

substances in Risk Group 4.

The proposed exception specifies that the material must be

contained in combination packagings consisting of one or more inner

packagings inside an outer packaging. The capacity of each inner

packaging may not exceed 0.5 kg (1.1 pound) or 0.5 L (17 ounces), and

the capacity of the outer packaging may not exceed 4 kg (8.8 pounds) or

4 L (1 gallon). The proposed exception also permits combination

packagings consisting of a single inner packaging with a capacity that

does not exceed 16 kg (35.2 pounds) or 16 L (4.2 gallons) contained

inside a single outer packaging. For RMW in combination packagings,

each inner packaging may not exceed 4 kg (8.8 pounds) or 4 L (1 gallon)

and the outer packaging may not exceed 16 kg (35.2 pounds) or 16 L (4.2

gallons). Under this proposal, infectious substances transported as

materials of trade are subject to the general packaging, hazard

communication, and motor vehicle operator notification requirements

currently specified in Sec. 173.6. The proposed materials of trade

exception would apply to entities such as home health care providers

and diagnostic laboratories that transport smaller amounts of

infectious substances. We believe that the increased knowledge of the

personnel handling these materials, most of whom are trained in the

requirements of the Occupational Safety and Health Administration's

(OSHA) Universal Precaution regulations for handling potentially

contaminated material, will substantially reduce the risks associated

with their transportation. In addition, the exception imposes minimum

packaging requirements, at minimal cost, for materials currently

excepted from the HMR.

D. Diagnostic Specimens

In the ANPRM, we proposed removing the existing broad exception

from the HMR for diagnostic specimens and creating a regulatory system

based on the WHO risk group definitions that requires diagnostic

specimens to be packaged, described, and transported in a manner

consistent with their level of risk. We proposed retaining the broad

exception from the HMR for diagnostic specimens assigned to Risk Group

1 only. Further, we proposed exceptions to distinguish between a

diagnostic specimen known or suspected to contain an infectious

substance and one sent for routine testing.

The majority of comments we received in response to the ANPRM

address the proposed regulations for diagnostic specimens. Most

commenters oppose increased regulation for diagnostic specimens,

suggesting that the proposed regulations are not justified by the

safety record and will be difficult and costly to implement. Commenters

further state that the proposed regulations could result in shipment

delays, making early detection and treatment of disease difficult.

Commenters note that shippers of diagnostic specimens may have little

or no knowledge of what pathogens a given specimen may contain, making

application of the WHO risk groups to such materials difficult, at

best. Finally, commenters state that the proposed regulations could

significantly increase health care costs.

Commenters who support regulation of diagnostic specimens note that

releases of these materials do occur in transportation. These

commenters generally support removal of the current exception from the

HMR for diagnostic specimens to ensure packaging quality and to protect

transportation workers and the general public from the risk of exposure

to potentially infectious materials.

We agree with commenters that diagnostic specimens should be

subject to regulation under the HMR. Our HMIS data base includes

reports of packages containing these materials that were damaged in

transportation, resulting in delays and possible risk to cargo

handlers, flight crews, emergency responders, and the general public.

However, we also agree with commenters that the regulatory requirements

proposed in the ANRPM could increase transportation costs for shipment

of these materials.

Accordingly, in this NPRM, we are proposing regulations applicable

to the transportation of diagnostic specimens that are consistent with

proposed amendments to the UN Recommendations. We propose a new entry

in the Hazardous Materials Table--``Diagnostic Specimen.'' There is no

UN number, hazard warning label, or packing group assignment.

Under this proposal, diagnostic specimens meeting the definition of

a Risk Group 4 material are classed and transported as Division 6.2

materials, UN 2814 or UN 2900. All other diagnostic specimens must be

packaged in primary receptacles packed inside secondary packaging to

preclude breakage, punctures, or leakage, and, for liquids, with

sufficient absorbent

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material to absorb the entire contents of the primary receptacle. The

secondary packaging must be secured in outer packagings with suitable

cushioning material. For liquids transported by aircraft, either the

primary receptacle or the secondary packaging must be capable of

withstanding an internal pressure producing a pressure differential of

at least 95kPa (0.95 bar, 14 psi). The completed package must be

capable of passing a drop test from a height of at least 1.2 meters

(3.9 feet). The package must be marked with the words ``Diagnostic

Specimens.'' Diagnostic specimens shipped in conformance with these

proposed provisions are excepted from other requirements in the HMR,

except that diagnostic specimens transported on board aircraft are

subject to the incident reporting requirements in Secs. 171.15 and

171.16. Under this proposal, offerors and transporters of diagnostic

specimens must be informed of the diagnostic specimen packaging

requirements.

In addition to the materials of trade exception discussed above, we

are also proposing a complete exception from the HMR for diagnostic

specimens transported by private or contract motor carriers. Based on

comments received in response to the ANPRM, it is our understanding

that most diagnostic specimens are shipped from collection sites (e.g.,

physicians' offices, nursing homes, clinics, etc.) to testing

laboratories by private or contract couriers in dedicated vehicles. The

couriers are familiar with the materials they transport and trained in

the application of the OSHA Universal Precautions for handling

materials that may contain infectious substances. Our proposal would

require couriers to be informed about the materials they are

transporting. This proposed exception will enable the transportation of

diagnostic specimens quickly, efficiently, and safely to testing

laboratories.

It should be noted that waste diagnostic specimens--that is,

diagnostic specimens that meet the proposed definition for RMW in this

NPRM--could not be transported under the exceptions proposed in this

NPRM for the transportation of diagnostic specimens. Waste diagnostic

specimens would lose their identity as diagnostic specimens for

purposes of the HMR and would have to be transported in accordance with

the HMR requirements applicable to RMW.

Taken together, we believe that these proposals for the

transportation of diagnostic specimens are cost-effective, practical,

and easy to understand and implement. Most important, these proposals

will assure an adequate level of safety.

E. Biological Products

Commenters to the ANPRM generally support its proposals concerning

transportation of biological products. Under current provisions,

biological products are excepted from the HMR provided they meet Food

and Drug Administration (FDA) or U.S. Department of Agriculture (USDA)

regulations governing the transfer of biological products. In this

NPRM, we propose to limit this exception to biological products that

meet the definition of a Risk Group 1 material or are licensed for use

under current FDA or USDA regulations. We propose to require unlicensed

biological products meeting the definition of a Risk Group 2, 3, or 4

infectious substance to be classed as infectious substances, Division

6.2, and packaged in specification packagings authorized for the

transportation of infectious substances.

In addition, we are proposing to add a special provision in

Sec. 172.102, consistent with ICAO Technical Instruction Special

Provision A81, to except blood and blood products from current quantity

limits for shipments by air when the materials are packaged in primary

receptacles that do not exceed 500 ml (17 ounces) and contained in

outer packagings not exceeding 4 L (1 gallon).

We also propose to except from all HMR requirements blood collected

for blood transfusions, blood collected for the preparation of blood

products, blood products intended for transplant, and tissues and

organs intended for transplant.

It should be noted that waste biological products--that is,

biological products that meet the proposed definition for RMW in this

NPRM--may not be transported under the exceptions proposed in this NPRM

for the transportation of biological products. Waste biological

products lose their identity as biological products for purposes of the

HMR and, if they contain infectious substances, must be transported in

accordance with the HMR requirements applicable to RMW.

F. Genetically Modified Micro-Organisms

The UN Recommendations and the ICAO Technical Instructions treat

any genetically modified micro-organism that meets the definition of a

Division 6.2 material as an infectious substance. In addition, these

international standards class a genetically modified micro-organism

that does not meet the definition of a Division 6.2 material, but is

capable of altering plants, animals, or microbiological substances in a

way not normally the result of natural reproduction, as a Class 9

material. The UN Recommendations also contain a provision that excludes

from regulation genetically modified micro-organisms that are

authorized and licensed for use by the government of origin, transit,

and destination.

In the ANPRM, we invited comment on whether the HMR should

incorporate the international transportation standards for genetically

modified micro-organisms. Commenters who addressed this issue are

concerned that the proposed regulations could interfere with food and

animal production. We appreciate their concerns, but we believe that

the potential for environmental and property damage as a result of the

release of genetically modified micro-organisms in transportation

justifies their regulation as Class 9 materials.

Accordingly, in this NPRM, we propose to add ``Genetically modified

micro-organism'' to the Hazardous Materials Table as a Class 9

material. Under this proposal, these materials must be packaged in

conformance with the requirements for packaging infectious substances,

except that the packagings need not be marked or tested in accordance

with Part 178 requirements.

The NPRM proposes two exceptions applicable to the transportation

of genetically modified micro-organisms. First, we propose to except

genetically modified micro-organisms from all requirements in the HMR

if a federal government agency authorizes their final distribution and

use. Second, we propose to except genetically modified micro-organisms

from HMR requirements when transported in a non-passenger-carrying

transport vehicle operated by a private or contract motor carrier. The

materials must be packaged to conform to the provisions described

above, and the package must be marked with the proper shipping name

``Genetically modified micro-organism.'' Further, our proposal requires

couriers to be informed about the materials they are transporting.

G. Regulated Medical Waste

Commenters generally support the proposals outlined in the ANPRM to

permit transportation of RMW in non-specification bulk packagings.

Currently, bulk packagings for the transportation of RMW are only

authorized under the terms of 29 exemptions. For the most part, these

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packagings have demonstrated that they provide an acceptable level of

safety in transportation.

To ensure consistency with international regulations and to provide

the broadest selection of authorized bulk packagings, we are also

proposing to allow the use of ``Large Packagings,'' which are

intermediate bulk packagings containing one or more inner packagings

consistent with the requirements of the UN Recommendations. A

definition for these packagings was proposed in an NPRM issued under

Docket HM-215D, published October 23, 2000 (65 FR 63294) and in the

International Maritime Dangerous Goods Code and ICAO's Technical

Instructions. As proposed under HM-215D, a Large Packaging consists of

an outer packaging containing articles or inner packagings and designed

for mechanical handling. A Large Packaging has a capacity greater than

400 kg (882 lbs.) or 450 liters (119 gallons), but does not exceed 3

cubic meters in volume.

Accordingly, in this NPRM we propose to authorize Large Packagings

and certain non-specification bulk containers for use as outer

packagings for the transportation of RMW. Plastic film bags meeting

performance and test requirements for impact and tear resistance are

authorized as inner packagings for solid RMW. Inner packagings for

liquid RMW must be rigid, leak resistant, puncture resistant, break

resistant, impervious to moisture, and sealed to prevent leakage.

In addition to the above, we propose to revise the quantity

limitations applicable to shipments of RMW on aircraft. Currently, such

shipments are forbidden. We propose to revise the quantity limitations

for non-bulk shipments of RMW on board aircraft to read ``No limit''

for consistency with the ICAO Technical Instructions applicable to

quantity limitations for RMW on airplanes. We propose to continue to

prohibit bulk shipments of RMW on board aircraft.

H. Used Health Care Products

One commenter suggests that the HMR include an exception for used

health care products. The commenter states that used health care

products potentially contaminated with infectious substances, such as

wound care and sanitary products, surgical equipment, diagnostic and

blood testing products, and contraceptives used by consumers, medical

professionals, and pharmaceutical providers are routinely returned to

manufacturers. Used health care products may be returned for assessment

of clinical trials, new product development, customer complaints,

product investigations for government compliance, service and repair,

and competitor trade-ins.

The infectious status of many of these returned used health care

products may not be known. An individual consumer may be unaware that

he has an infectious disease or may be reluctant to reveal this

information, or a patient may be infectious, but not symptomatic. In

addition, patient confidentiality requirements prohibit health care

providers from communicating a patient's infectious status to others.

Further, in the case of potentially contaminated used health care

products, it is the inanimate product that is being shipped, not the

infectious agent. While used health care products may be contaminated

with human blood or other body fluids or tissues, these substances

usually are dried on the health care product. Special conditions

necessary to promote or sustain biological integrity are not available

prior to or during shipment. If infectious agents are present on used

health care products, they are, in the words of the commenter,

``unwanted hitchhikers'' and are subject to hostile conditions that may

inactivate pathogens over time or, at least, do not support their

amplification.

The commenter suggests that neither the HMR nor international

standards clearly address the shipment of potentially contaminated used

health care products. We agree. Thus, in this NPRM we are proposing to

except used health care products being returned to the manufacturer

from the requirements of the HMR provided the products are shipped in a

triple packaging that conforms to certain manufacturing and marking

requirements. Under this proposal, the primary and secondary containers

must be marked with the OSHA BIOHAZARD symbol and must be constructed

of metal or plastic in a manner that assures that they remain intact

during transportation. Under this NPRM, offerors and transporters of

used health care products potentially contaminated with an infectious

substance must be informed about the used health care product packaging

requirements.

I. Hazard Communication

In the ANPRM, we stated that we are considering several options

with respect to the marking or placarding of bulk packagings and

transport vehicles containing infectious substances, including RMW.

Some commenters support a requirement for Division 6.2 placards on each

vehicle or bulk packaging that contains any quantity of a Risk Group 4

infectious substance because of the extreme risks to emergency

responders and the general public associated with the possible release

of such material. These commenters also generally support a requirement

for placards on all bulk shipments of infectious substances. Commenters

who oppose placarding for shipments of infectious substances suggest

that such a requirement is unnecessary, noting that there are

significant differences in the potential harm that could result from a

transportation incident involving infectious substances as compared to

one involving flammable, toxic, or explosive materials.

We agree with commenters that communication of a Risk Group 4

hazard to transportation workers and emergency response personnel is

important. However, we are concerned that placarding transport vehicles

containing Risk Group 4 infectious substances could compromise the

security of the shipments. Further, shipments of Risk Group 4

infectious substances are strictly controlled by CDC regulation. Thus,

we are not proposing a placarding requirement in this NPRM.

However, we believe bulk packagings and transport vehicles

containing RMW should be marked to communicate to emergency response

personnel the nature of the material being transported. We are aware

that a number of states and local governments have promulgated marking

regulations applicable to the transportation of RMW. Many of these

state and local regulations include a requirement for vehicles

containing shipments of RMW to be identified with a marking similar to

the BIOHAZARD symbol prescribed by OSHA regulations for containers of

potentially infectious material. State, local, and tribal governments

should be aware that the preemption provisions of Federal hazardous

materials transportation law (federal hazmat law; 49 U.S.C. 5101 et

seq.) generally preclude non-federal governments from imposing

requirements applicable to hazardous materials transportation if such

requirements are not consistent with the HMR. 49 U.S.C. 5125. Thus, in

the absence of a waiver of preemption by the Secretary, where state or

local requirements conflict with or are inconsistent with the HMR

requirements, the HMR control.

Federal hazmat law codifies the ``dual compliance'' and

``obstacle'' criteria for preemption of non-federal regulations. As set

forth in 49 U.S.C. 5125(a), these criteria provide that, in the absence

of a waiver of preemption by the Secretary

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under 49 U.S.C. 5125(e) or unless it is authorized by another federal

law, a requirement of a state, political subdivision of a state, or

Indian tribe is explicitly preempted if:

(1) complying with a requirement of the state, political

subdivision or Indian tribe and a requirement of Federal hazardous

materials transportation law or a regulation issued under the law is

not possible; or

(2) the requirement of the state, political subdivision, or Indian

tribe, as applied or enforced, is an obstacle to accomplishing and

carrying out Federal hazardous materials transportation law or a

regulation prescribed under the law.

Federal hazmat law also includes additional preemption provisions

on certain ``covered subject'' areas. The covered subject areas are:

(a) The designation, description, and classification of hazardous

material.

(b) The packing, repacking, handling, labeling, marking, and

placarding of hazardous material.

related to hazardous material and requirements related to the number,

contents, and placement of those documents.

(d) The written notification, recording, and reporting of the

unintentional release in transportation of hazardous material.

(e) The design, manufacturing, fabrication, marking, maintenance,

reconditioning, repairing, or testing of a package or container

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

transporting hazardous material. 49 U.S.C. 5125(b).

Marking is a covered subject for purposes of preemption. Thus,

unless authorized by another federal law or a waiver of preemption from

the Secretary of Transportation, a non-federal marking requirement is

preempted when it is not ``substantively the same'' as federal hazmat

law or a regulation issued under it. 49 U.S.C. 5125(b)(1).

In the interest of uniformity, we believe it is essential that

state, local, and tribal marking requirements be consistent from

jurisdiction to jurisdiction. Thus, in this NPRM, we propose to require

bulk packagings containing RMW to be marked with the appropriate UN

identification number. We are also proposing to require bulk packagings

of RMW to be identified with a BIOHAZARD marking that conforms to OSHA

specifications for the BIOHAZARD marking in 29 CFR 1910.1030(g)(1)(i).

In this NPRM, we are also proposing to revise the INFECTIOUS

SUBSTANCE label to reflect the new toll-free number to report

infectious substances incidents to the CDC. That toll-free number is 1-

800-232-0124.

J. Petitions for Rulemaking

The ANPRM requested comments on a petition for rulemaking (P-1350)

submitted by the Medical Waste Institute (MWI) requesting relief for

transportation of waste cultures and stocks that meet the definition

for Division 6.2 materials. Specifically, MWI requests that we revise

the HMR to allow contract and private motor carriers to transport

discarded cultures and stocks of infectious substances in non-

specification packagings if the carriers use dedicated vehicles.

Currently, under Sec. 173.134(b)(3), the HMR allow this type of

transportation for RMW that does not contain a culture or stock of an

infectious substance.

In support of its petition, MWI states that the current packagings

required in the HMR for discarded cultures and stocks are not justified

because they are expensive and lack a safety record that proves their

actual public health and safety benefits. With its petition, MWI

includes HMIS and state incident data on infectious substances for the

period 1989 through March 1997.

Experience under exemption DOT-E 11588 has demonstrated that

Packing Group II packagings transported by a private or contract

carrier in dedicated vehicles provide an acceptable level of protection

for waste cultures and stocks of infectious substances. Private and

contract carriers that transport these materials have an increased

level of knowledge about these materials. Moreover, the use of

dedicated vehicles limits public exposure and assures that packages are

handled by experienced personnel. We also have found that the general

packaging requirements in Secs. 173.24 and 173.24a, coupled with OSHA's

packaging requirements in 29 CFR 1910.1030 for bloodborne pathogens,

are adequate for less virulent types of infectious substances.

Therefore, in this NPRM, we are proposing to revise Sec. 173.134(b) to

permit transportation of waste cultures and stocks of Risk Group 2 or 3

infectious substances in non-specification packagings when transported

by private or contract carriers in dedicated vehicles.

IV. Section-by-Section Review

Part 171

Section 171.7

We propose to revise the table of material incorporated by

reference to add two new references to test methods developed by the

American Society for Testing and Materials. These tests would be

required for plastic inner packagings used to transport RMW inside

Large Packagings and non-specification bulk packagings.

Section 171.8

We propose to add definitions for ``biological product,''

``cultures and stocks,'' ``diagnostic specimen,'' ``genetically

modified micro-organism,'' ``risk group,'' ``sharps,'' and ``toxin.''

These definitions would refer readers to the definitions in Part 173 of

the HMR.

Section 171.14

We propose to allow a two-year transition period for Division 6.2

labels revised as proposed in this NPRM.

Section 171.15

We propose to remove the term ``etiologic agents'' from paragraphs

(a)(3) and (b) and replace it with ``infectious substances.'' In

addition, in paragraph (b) we propose to add