[Federal Register Volume 66, Number 14 (Monday, January 22, 2001)]
[Proposed Rules]
[Pages 6942-6962]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-92]



[[Page 6941]]

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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

  Federal Register / Vol. 66 , No. 14 / Monday, January 22, 2001 / 
Proposed Rules  

[[Page 6942]]


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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

[[Page 6943]]

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

[[Page 6944]]

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

[[Page 6946]]

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

[[Page 6947]]

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.
    (c) The preparation, execution, and use of shipping documents 
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 wording to emphasize that 
a written report of an incident involving infectious substances must be 
submitted to RSPA.

Part 172

Section 172.101

    For the entry ``Regulated medical waste,'' we propose to remove the 
letter ``D'' in column (1). In column (7), we propose to remove the 
reference to Special Provision A14 and to revise columns (9A) and (9B) 
to replace ``Forbidden'' with ``No Limit'' for quantity limitations on 
board aircraft. These proposed changes harmonize requirements in the 
HMR with those in the ICAO Technical Instructions and facilitate the 
transportation of RMW in non-bulk packagings by aircraft. In addition, 
column 8C is revised to replace ``none'' with 197, to indicate that 
bulk packagings authorized for the transportation of RMW can be found 
in Sec. 173.197 of the HMR. Finally, we propose to revise Special 
Provision A13 to prohibit the transportation of bulk packagings of RMW 
by aircraft.
    For the entries ``Infectious substances, affecting animals only'' 
and ``Infectious substances, affecting humans,'' we propose to add new 
special provisions in column (7). Special Provision A81 provides relief 
from quantity limits for the transport of blood or blood products that 
contain infectious substances when in primary receptacles not exceeding 
500 ml (17 ounces) and in outer packagings not exceeding 4L (1 gallon) 
and packaged in accordance with Sec. 173.196. Special Provision A82 
provides relief from UN standard packaging for transporting body parts, 
whole organs, and whole bodies.

[[Page 6948]]

    We propose to add a new entry, ``Genetically modified micro-
organism,'' to the Table as a Class 9 material consistent with entries 
in the UN Recommendations, ICAO Technical Instructions, and 
International Maritime Dangerous Goods Code.
    In addition, we propose to add a new entry, ``Diagnostic 
specimen'', to the Table as a Division 6.2 material. There is no UN 
number, hazard warning label, or packing group assignment.
    We also propose to add two new entries for ``Toxins, liquid, 
extracted from living sources, n.o.s., UN 3172'' and ``Toxins, solid, 
extracted from living sources, n.o.s., UN 3172.'' For both entries, a 
``G'' in column (1) indicates that the shipping description on shipping 
papers must include the technical names for the materials. Both entries 
indicate that the materials are Division 6.1 materials, UN 3172, PG I, 
II, or III. We propose to add Special Provision 141 to state that 
toxins that contain infectious substances or are contained in 
infectious substances must be classed as Division 6.2 materials and 
assigned to UN 2814 or UN 2900, as appropriate.

Section 172.102

    We propose to revise this section by removing Special Provision 
A14, revising Special Provision A13, and adding Special Provisions 141, 
A81, and A82, as detailed above.

Section 172.323

    We propose to add this section to require bulk packagings 
containing RMW to be marked with a BIOHAZARD marking conforming to OSHA 
regulations at 29 CFR 1910.1030.

Section 172.432

    We propose to revise the INFECTIOUS SUBSTANCE label to incorporate 
the new toll-free telephone number (1-800-232-0124) for reporting 
incidents to the CDC.

Part 173

Section 173.6

    We propose to add a materials of trade exception for diagnostic 
specimens, biological products, and RMW, other than Risk Group 4 
materials. The proposed exception includes packaging requirements and 
quantity limitations.

Section 173.28

    We propose to require Division 6.2 packagings to be decontaminated 
prior to reuse.

Section 173.134

    In paragraph (a), we propose to revise the definitions and 
classification criteria for ``infectious substance,'' ``biological 
product,'' ``diagnostic specimen,'' and ``regulated medical waste'' and 
to add definitions for ``cultures and stocks,'' ``risk group,'' 
``sharps,'' and ``toxin.''
    We propose to revise the definition of ``infectious substance'' for 
consistency with international standards and to require materials 
meeting the definition of an infectious substance to be assigned to 
risk groups based on the degree to which they cause injury through 
disease. Infectious substances assigned to Risk Group 1 are not subject 
to regulation under the HMR.
    We propose to revise the definition of ``biological product'' to 
require biological products known to contain or suspected to contain a 
pathogen in Risk Groups 2, 3, or 4 to be classed as Division 6.2 
materials, unless otherwise excepted.
    We propose to define ``cultures and stocks'' to mean a material 
that is prepared and maintained for growth and storage and that 
contains a Risk Group 2, 3, or 4 infectious substance.
    We propose to revise the definition of ``diagnostic specimen'' to 
require a diagnostic specimen known to contain or suspected to contain 
a Risk Group 4 pathogen to be classed as a Division 6.2 material. This 
determination is based on the known medical history and condition of 
the patient or animal, endemic local conditions, symptoms of the source 
patient or animal, or professional judgement concerning the individual 
circumstances of the patient or animal.
    We propose to revise the definition for ``regulated medical waste'' 
to indicate that regulated medical waste is a waste or reusable 
material that contains or is suspected to contain a Risk Group 2 or 3 
infectious substance. As proposed in this NPRM, regulated medical waste 
containing a Risk Group 4 infectious substance must be classed and 
transported as a Division 6.2 material, UN 2900 or UN 2814.
    We propose to define ``risk group'' to mean a ranking of a micro-
organism's ability to cause injury through disease. Risk group 
assignment criteria include the pathogenicity of the organism, the mode 
and relative ease of transmission, the degree of risk to both an 
individual and a community, and the reversibility of the disease 
through the availability of effective preventive agents and treatments.
    We propose to define ``sharps'' to mean any object that may be 
contaminated with an infectious substance that is also able to cut or 
penetrate the skin or packaging material. The term includes needles, 
scalpels, broken glass, culture slides, culture dishes, broken 
capillary tubes, broken rigid plastic, and exposed ends of dental 
wires.
    We propose to define ``toxin'' to mean a Division 6.1 material 
secreted from a plant, animal, or bacterial source. The proposed 
definition notes that toxins that contain an infectious substance or 
are contained in an infectious substance must be classed as Division 
6.2 materials.
    In paragraph (b), we propose to list exceptions from the HMR 
requirements applicable to Division 6.2 materials. Proposed exceptions 
include:
    1. Biological products licensed/approved for public dissemination 
by FDA or USDA;
    2. Blood collected for transfusions or the preparation of blood 
products, and blood products, tissues, and organs intended for 
transplant;
    3. Diagnostic specimens or biological products transported by 
private or contract motor carriers in dedicated motor vehicles;
    4. Material treated so that it no longer contains an infectious 
substance;
    5. Sanitary waste and sewage;
    6. Sewage sludge and compost;
    7. Animal waste generated in animal husbandry or food production;
    8. Corpses and anatomical parts intended for interment, cremation, 
or research; and
    9. Forensic material transported on behalf of the federal 
government or a state, local government, or tribal government agency.
    We also propose to modify the exception for medical waste generated 
from households to indicate that such medical waste must be transported 
in accordance with applicable state, local, or tribal government 
requirements.
    In addition, we propose to revise the exception for laundry or 
medical equipment conforming to OSHA regulations in 29 CFR 1910.1030 to 
clarify that this exception applies to medical equipment intended for 
reuse and equipment used for testing. The revised definition further 
clarifies that the exception does not apply to medical equipment 
transported for disposal.
    In paragraph (c), we propose to modify the exception for RMW 
transported by contract or private carriers to include waste cultures 
and stocks that contain Risk Group 2 or 3 infectious substances.
    Finally, we propose to add paragraph (d) to clarify that if an item 
listed in paragraphs (b) or (c) of this section meets the definition of 
another hazard class or if it is a hazardous substance, hazardous 
waste, or marine pollutant, it must be offered for transportation and

[[Page 6949]]

transported in accordance with applicable requirements of the HMR.

Section 173.140

    We propose to add new paragraphs (c) and (d) to provide defining 
criteria and exceptions for genetically modified micro-organisms that 
do not meet the definition of a Division 6.2 material, but that have 
the potential to alter animals, plants, or the environment. These 
materials are assigned to the Class 9 hazard class. Genetically 
modified micro-organisms that meet the criteria for a Division 6.2 
material must be classed as infectious substances. We propose to except 
genetically modified micro-organisms from HMR requirements if a federal 
government agency authorizes their final distribution and use. We also 
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.

Section 173.196

    We propose to revise this section for clarity and consistency with 
the UN Recommendations and ICAO Technical Instructions. These revisions 
include packaging and overpack marking requirements to ensure the 
integrity of the packagings during air transport, including 
circumstances where the refrigerant is dissipated or lost. A new 
paragraph (d) is added to prescribe non-specification packaging 
provisions for body parts.

Section 173.197

    We propose to revise this section to authorize certain bulk 
packagings for the transportation of RMW. Paragraph (a) proposes 
general requirements for both non-bulk and bulk packagings. Proposed 
paragraph (b) requires non-bulk packagings to conform to the 
requirements of part 178 at the Packing Group II performance level. 
Proposed paragraphs (c) and (d) authorize Large Packagings and non-
specification bulk containers for the transportation of RMW. These 
proposed packaging provisions are based on the terms of 29 current 
exemptions and our own initiative. Proposed paragraph (c) sets forth 
conditions governing the use of Large Packagings. Proposed paragraph 
(d) sets forth the conditions governing the use of non-specification 
wheeled carts and bulk outer packagings. Proposed paragraph (e) 
specifies the inner packagings authorized for use with bulk outer 
packagings.

Section 173.199

    We propose to add a new Sec. 173.199 to address packaging 
requirements for diagnostic specimens and used health care products. 
Diagnostic specimens meeting the definition of a Risk Group 4 material 
must be classed and transported as infectious substances, UN 2814 or UN 
2900. Generally, we propose to permit all other diagnostic specimens to 
be shipped in triple packagings that are capable of passing a 1.2 meter 
(3.9 feet) drop test.
    We propose to require liquid diagnostic specimens to be packaged in 
leakproof primary receptacles with a volumetric capacity of not more 
than 500 ml (17 ounces). For shipments by aircraft, the primary 
receptacle or secondary packaging must be able to withstand without 
leakage an internal pressure producing a pressure differential of not 
less than 95 kPa (0.95 bar, 14 psi). The secondary packaging must be 
leakproof and impervious to moisture. The volumetric capacity of the 
outer packaging may not exceed 4 L (1 gallon).
    We propose to require solid diagnostic specimens to be packaged in 
a siftproof primary receptacle with a capacity of not more than 500 g 
(1.1 pounds). The secondary packaging must be leakproof. The capacity 
of the outer packaging may not exceed 4 kg (8.8 pounds).
    We propose to permit shipment of used health care products being 
returned to the manufacturer in triple packagings, in which the primary 
and secondary containers must be constructed of plastic or metal and 
must be marked with the OSHA BIOHAZARD symbol. A used health care 
product that can cut or penetrate skin or packaging material must be 
transported in a puncture-resistant primary container.
    Under this proposal, diagnostic specimens and used health care 
products shipped in accordance with these provisions are not subject to 
any other requirements in the HMR, except for minimal training 
requirements and, for diagnostic specimens, incident reporting for 
shipments offered for transportation or transported by aircraft.

Section 173.200

    We propose to add a new Sec. 173.200 to address packaging 
requirements for genetically modified micro-organisms. We propose to 
require genetically modified micro-organisms to be packaged in 
conformance with Sec. 173.196, except that the packagings need not be 
marked in accordance with Sec. 178.503 nor tested in accordance with 
Sec. 178.609. Alternatively, we propose to permit genetically modified 
micro-organisms to be transported in packagings that meet the 
specifications in Secs. 173.203 or 173.213 at the Packing Group III 
performance level.

Part 177

Section 177.834

    We propose to revise paragraphs (a) and (g) to indicate that 
packages containing Division 6.2 materials must be properly secured in 
a transport vehicle.

Section 177.843

    We propose to add a new paragraph (d) to require a transport 
vehicle to be decontaminated prior to reuse if a Division 6.2 material 
is released from its packaging inside the vehicle.

Part 178

Section 178.503

    We propose to add a new paragraph (f) to incorporate package 
markings for infectious substances packagings consistent with those in 
the ICAO Technical Instructions and the UN Recommendations.

Section 178.601

    We propose to add a sentence to paragraph (c)(1) of this section to 
include the tests for infectious substance packaging in the definition 
of design qualification testing. As a result of this proposed change, 
manufacturers of infectious substances packagings are required to 
retain design qualification records in accordance with 
Sec. 178.601(c)(l). In addition, we propose to add a sentence to 
paragraph (c)(2) to indicate that, for infectious substances 
packagings, periodic retesting is the performance of tests specified in 
Sec. 178.609 at the frequency specified in Sec. 178.601(e). Finally, we 
propose to add a sentence to paragraph (e) to require packagings used 
to transport infectious substances to pass periodic retests.

Section 178.609

    We propose to revise the section heading to remove the wording 
``(etiologic agents).'' We propose to revise paragraph (c) to permit 
the use of expanded plastics for inner packagings and require the 
packaging tests to be determined by the most fragile inner packaging. 
Paragraphs (d)(1)(i), (d)(1)(iii), and (d)(1)(iv) are revised for 
clarity. We propose to revise paragraph (e) to replace the current 
water immersion test with a water spray test that simulates exposure to 
rainfall consistent with the ICAO Technical Instructions. Paragraphs 
(h)(1) and (h)(2) are revised to clearly indicate that,

[[Page 6950]]

during the penetration test, penetration of the primary receptacle is 
not acceptable. Current paragraph (i) is deleted. We propose to add new 
paragraph (i) to incorporate the selective testing provisions in the UN 
Recommendations and ICAO Technical Instructions. These provisions allow 
variations in the primary receptacles within the secondary packaging 
without further testing of the completed packaging if an equivalent 
level of performance is maintained.

V. Regulations of Other Agencies

    In addition to RSPA, several federal agencies have responsibility 
for regulating infectious substances and genetically modified micro-
organisms.

A. Centers for Disease Control and Prevention

    The Department of Health and Human Services is authorized to 
promulgate regulations to prevent the introduction, transmission, and 
spread of communicable diseases in the United States. CDC has been 
delegated authority to regulate the interstate shipment of infectious 
substances. The current CDC regulations are codified at 42 CFR Part 72. 
The regulations provide requirements for minimum packaging and labeling 
for diagnostic specimens and biological products, and include a list of 
select agents for which special labeling and tracking is required.
    On October 28, 1999, CDC published an NPRM, proposing to clarify 
and expand existing requirements for proper packaging and handling of 
infectious substances (64 FR 58022). The NPRM includes proposals to 
ensure that all biological materials known or suspected to contain an 
infectious substance are packaged to minimize the potential for leakage 
during transit. The proposed regulations are intended to harmonize CDC 
regulations with those of other federal agencies and with international 
standards.

B. Occupational Safety and Health Administration

    The Department of Labor's Occupational Safety and Health 
Administration (OSHA) is authorized to assure safe and healthy 
workplaces by the Occupational Safety and Health Act of 1970 (OSH Act). 
OSHA regulations governing occupational exposure to bloodborne 
pathogens in human blood and body fluids, unfixed tissues, organs, cell 
cultures, and other fluids from humans or animals are codified at 29 
CFR Part 1910.1030. The regulations require persons who handle 
bloodborne pathogens to utilize Universal Precautions as a means of 
infection control. The Universal Precautions require human blood and 
body fluids to be treated as if known to be infectious. Among other 
requirements, the regulations require specimens of blood or other 
potentially infectious materials to be placed in containers that 
prevent leakage during collection, handling, processing, storage, or 
transport. The regulations also require containers of potentially 
infectious material to be labeled with a BIOHAZARD label.

C. Food and Drug Administration

    The Food and Drug Administration (FDA) regulates, licenses, and 
approves biological and related products to ensure their purity, 
potency, safety, and efficacy. FDA regulates vaccines, blood 
derivatives, allergenic extracts, blood components, whole blood, 
tissues, monoclonal antibodies, biotech derived products, somatic cell 
and gene therapies, in vitro diagnostics, and medical devices. FDA's 
regulations are codified at 21 CFR Parts 1-1299.

D. U.S. Department of Agriculture

    The U.S. Department of Agriculture's (USDA) Center for Veterinary 
Biologics assures that pure, safe, potent, and effective veterinary 
biological products are available for the diagnosis, prevention, and 
treatment of animal diseases. The program assures that biological 
products are free of disease-producing agents, develops appropriate 
standards and procedures for product release, issues licenses and 
permits, monitors and inspects products and facilities, and controls 
field tests and the release of veterinary biological products. USDA 
regulations for veterinary biological products are codified at 9 CFR 
parts 101-124.
    Several USDA agencies regulate and monitor the use of biotechnology 
for agriculture. The Animal and Plant Health Inspection Service 
regulates the movement, importation, and field testing of Genetically 
Engineered Organisms (GEOs) through permitting and notification 
procedures. The Food Safety Inspection Service has responsibility for 
the safe use of engineered domestic livestock, poultry, and products 
derived from them. The Agricultural Research Service conducts in-house 
research on GEOs. The Cooperative State Research, Education, and 
Extension Service administers the biotechnology risk assessment program 
as well as research programs in gene mapping, sequencing and 
biotechnology applications. USDA regulations applicable to GEOs are at 
7 CFR part 340.

E. Actions to Assure Regulatory Consistency

    A number of commenters to the ANPRM urged us to work with other 
federal agencies to assure that regulations applicable to the 
transportation of infectious substances are compatible. We agree that 
persons who offer for transportation or transport infectious substances 
or genetically modified micro-organisms should not be forced to comply 
with several sets of inconsistent or conflicting regulations imposed by 
different federal regulatory agencies. We met with CDC to discuss its 
1999 NPRM and potential areas of conflict with the HMR and 
international standards. In addition, we provided CDC, USDA, FDA, and 
OSHA with copies of our NPRM in advance of publication in the Federal 
Register for their information and comment, and asked specifically for 
potential areas of conflict between their regulations and the proposals 
in this NPRM. None of these agencies identified any potentially 
conflicting regulatory requirements in their informal responses to our 
request. We encourage commenters to address this issue as well.

VI. Regulatory Analyses and Notices

A. Executive Order 12866 and DOT Regulatory Policies and Procedures

    This proposed rule is not a significant regulatory action under 
Executive Order 12866 and, therefore, was not reviewed by the Office of 
Management and Budget. This proposed rule is not a significant 
regulatory action under the Regulatory Policies and Procedures of the 
Department of Transportation (44 FR 11034). A preliminary regulatory 
evaluation that considers various regulatory alternatives is available 
for review in the public docket.
    The costs of these proposed regulations identified in the 
regulatory evaluation are attributed to the regulation of shipments of 
diagnostic specimens that include a Risk Group 2, 3 or 4 pathogen. Our 
tentative estimate of costs is slightly more than $2 million per year.
    Because of a lack of reliable information concerning deaths, 
injuries, property damage, and other costs attributable to incidents 
involving the release of an infectious substance, we are unable to 
quantify potential savings that may result from these proposed rules, 
if adopted as final. Affected parties and other concerned persons are 
requested to provide comments on costs and/or potential benefits.
    Benefits resulting from implementation of the NPRM proposals 
include the following:

[[Page 6951]]

    1. International harmonization: Harmonization of requirements in 
the HMR with standards specified in the UN Recommendations, ICAO 
Technical Instructions, IMDG Code, and TDG will remove current 
inconsistencies among the regulations, thereby facilitating efficient 
transportation of infectious substances across national borders. More 
importantly, harmonized regulations reduce the potential for 
misunderstanding and confusion and, thus, enhance safety.
    2. Conversion of exemptions to regulations of general 
applicability: Conversion of 29 exemptions applicable to the bulk 
transportation of RMW to regulations of general applicability will 
result in a slight cost savings to the 29 exemptions holders and 65 
parties-to-the-exemption holders. In addition, the industry will be 
able to take advantage of the added flexibility provided by the 
increased number of packaging options for transporting RMW.
    3. Modification of current exceptions for diagnostic specimens and 
biological products: We believe that potentially infectious diagnostic 
specimens and biological products should not be transported without 
regard to packaging and with no communication of hazard to those who 
may come into contact with them. The HMIS data base and anecdotal 
information indicate that packages of these currently excepted 
materials are sometimes damaged during transportation, resulting in 
delays and possible risk to cargo handlers, flight crews, emergency 
responders, and the general public. The proposed requirements in the 
NPRM for more stringent packaging for these materials combined with the 
proposed exceptions for transportation of these materials as materials 
of trade or by private or contract carriers in dedicated vehicles will 
assure swift and efficient transportation while reducing the risks to 
transportation workers and the general public. Enhancements to 
packaging would also reduce the risk of exposure for laboratory workers 
opening and handling packages at the point of receipt. The minimal 
level of regulation proposed for these materials would enhance overall 
safety while imposing insignificant costs on the regulated industry.
    4. New requirements for genetically modified micro-organisms: We 
believe that genetically modified micro-organisms that have not been 
approved for distribution should not be transported without regard to 
packaging and communication of hazard. Thus, we are proposing new 
packaging and hazard communication requirements for these currently 
unregulated materials. The proposal to incorporate into the HMR 
international standards applicable to genetically modified micro-
organisms will enhance transportation safety and reduce potential 
adverse environmental impacts while imposing minimal requirements on 
the regulated industry.
    Although we cannot assign definitive dollar amounts to these 
potential benefits, we believe that, taken together, the proposals are 
the least costly alternatives available for ensuring an acceptable 
level of transportation safety and that the potential benefits to 
society more than offset the potential costs associated with this 
proposed rule.

B. Executive Order 13132

    This proposed rule has been analyzed in accordance with the 
principles and criteria contained in Executive Order 13132 
(``Federalism''). This proposed rule would preempt state, local, and 
Indian tribe requirements but does not propose any regulation that has 
substantial direct effects on the states, the relationship between the 
national government and the states, or the distribution of power and 
responsibilities among the various levels of government. Therefore, the 
consultation and funding requirements of Executive Order 13132 do not 
apply.
    The Federal hazardous materials transportation law, 49 U.S.C. 5101-
5127, contains an express preemption provision (49 U.S.C. 5125(b)) that 
preempts state, local, and Indian tribe requirements on certain covered 
subjects. Covered subjects are:
    (1) The designation, description, and classification of hazardous 
materials;
    (2) The packing, repacking, handling, labeling, marking, and 
placarding of hazardous materials;
    (3) The preparation, execution, and use of shipping documents 
related to hazardous materials and requirements related to the number, 
contents, and placement of those documents;
    (4) The written notification, recording, and reporting of the 
unintentional release in transportation of hazardous material; or
    (5) The design, manufacture, fabrication, marking, maintenance, 
recondition, repair, or testing of a packaging or container 
represented, marked, certified, or sold as qualified for use in 
transporting hazardous material.
    This proposed rule addresses covered subject items 1-5 above and 
would preempt state, local, and Indian tribe requirements not meeting 
the ``substantively the same'' standard. This proposed rule is 
necessary to assure an acceptable level of safety for the 
transportation of infectious substances and facilitate international 
transportation of these materials.
    Federal hazardous materials transportation law provides at section 
5125(b)(2) that, if DOT issues a regulation concerning any of the 
covered subjects, DOT must determine and publish in the Federal 
Register the effective date of federal preemption. The 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. 
We propose that the effective date of federal preemption be one year 
from publication of a final rule in the Federal Register.

C. Executive Order 13084

    This proposed rule has been analyzed in accordance with the 
principles and criteria contained in Executive Order 13084 
(``Consultation and Coordination with Indian Tribal Governments''). 
Because this proposed rule does not significantly or uniquely affect 
the communities of the Indian tribal governments and does not impose 
substantial direct compliance costs, the funding and consultation 
requirements of Executive Order 13084 do not apply.

D. Regulatory Flexibility Act

    The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) requires an 
agency to review regulations to assess their impact on small entities 
unless the agency determines that a rule is not expected to have a 
significant impact on a substantial number of small entities. Based on 
the assessment in the preliminary regulatory evaluation, I hereby 
certify that while the proposed rule would apply to a substantial 
number of small entities, there would not be a significant economic 
impact on those small businesses. This certification is based upon a 
consideration that the identified costs are randomly distributed to the 
more than 441,000 establishments (offices and clinics of doctors of 
medicine, dentists, doctors of osteopathy, chiropractors, optometrists, 
podiatrists, and health practitioners; nursing and personal care 
facilities; hospitals; and medical and dental laboratories) that 
comprise Standard Industrial Classification (SIC) Major Group 80 
(Health Services). The slightly more than $2 million in annual costs 
attributed to this proposed rule is a mere fraction of the $300 billion 
in receipts reported by the health services industry. We believe none 
of those costs will be disproportionately borne by any of the 
identified groups of small businesses. If your business or organization 
is a small entity and if adoption of some or all of the proposed

[[Page 6952]]

provisions could have a significant economic impact on your operations, 
please submit a comment to explain how and to what extent your business 
or organization could be affected.

E. Paperwork Reduction Act

    RSPA has current information collection approvals under OMB No. 
2137-0039, Hazardous Materials Incident Reports, which expires March 
31, 2002, with 33,811 burden hours and $811,221.66 annual costs; and 
OMB No. 2137-0557, Approvals for Hazardous Materials, which expires 
August 31, 2003, with 180,302 burden hours and $413,737.40 annual 
costs. We believe that this proposed rule may result in an increase in 
annual burden hours and costs. If these proposals are finalized, the 
current approvals would be required to be revised and resubmitted to 
OMB for extension and re-approval.
    Section 1320.8(d), Title 5, Code of Federal Regulations requires 
RSPA to provide interested members of the public and affected agencies 
an opportunity to comment on information collection and recordkeeping 
requests. This notice identifies information collections that we may 
submit to OMB for extension and re-approval based on the requirements 
in this proposed rule. We have revised burden estimates, where 
appropriate, to reflect current reporting levels or adjustments based 
on changes in this proposed rule since the information collection was 
last approved. We estimate that the total information collection and 
recordkeeping burden as proposed in this rule would be revised as 
follows:
    OMB No.: 2137-0039.
    Total Annual Responses: 22,900.
    Total Annual Burden Hours: 34,441.
    Total Annual Burden Cost: $825,621.66.

    OMB No.: 2137-0557.
    Number of Respondents: 3,523.
    Total Annual Responses: 3,875.
    Total Annual Burden Hours: 18,405.
    Total Annual Burden Cost: $415,237.40.
    We specifically request comments on the information collection and 
recordkeeping burdens associated with developing, implementing, and 
maintaining these requirements for approval under this proposed rule.
    Requests for a copy of the information collection should be 
directed to Deborah Boothe, Office of Hazardous Materials Standards 
(DHM-10), Research and Special Programs Administration, Room 8102, 400 
Seventh Street, SW., Washington, DC 20590-0001, Telephone (202) 366-
8553.
    Written comments should be addressed to the Dockets Unit as 
identified in the ADDRESSES section of this rulemaking. Comments should 
be received prior to the close of the comment period identified in the 
DATES section of this rulemaking. Under the Paperwork Reduction Act of 
1995, no person is required to respond to an information collection 
unless it displays a valid OMB control number. If these proposed 
requirements are adopted in a final rule, RSPA will submit the revised 
information collection and recordkeeping requirements to the Office of 
Management and Budget for approval.

F. 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 contained in the heading of 
this document can be used to cross-reference this action with the 
Unified Agenda.

G. Unfunded Mandates Reform Act

    This NPRM imposes no mandates and thus does not impose unfunded 
mandates under the Unfunded Mandates Reform Act of 1995.

H. Environmental Assessment

    We find that there are no significant environmental impacts 
associated with this proposed rule. An environmental assessment has 
been placed in the public docket for this rulemaking.

List of Subjects

49 CFR Part 171

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

49 CFR Part 172

    Education, Hazardous materials transportation, Hazardous waste, 
Labeling, Markings, Packaging and containers, Reporting and 
recordkeeping requirements.

49 CFR Part 173

    Hazardous materials transportation, Packaging and containers, 
Radioactive materials, Reporting and recordkeeping requirements.

49 CFR Part 177

    Hazardous materials transportation, Motor carriers, Radioactive 
materials, Reporting and recordkeeping requirements.

49 CFR Part 178

    Hazardous materials transportation, Motor vehicle safety, Packaging 
and containers, Reporting and recordkeeping requirements.
    In consideration of the foregoing, we propose to amend 49 CFR parts 
171, 172, 173, 177, and 178 as follows:

PART 171--GENERAL INFORMATION, REGULATIONS, AND DEFINITIONS

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

    Authority: 49 U.S.C. 5101-5127; 49 CFR part 1.

    2. In Sec. 171.7, in the table in paragraph (a)(3), two new entries 
would be added in alphanumeric sequence under the American Society for 
Testing and Materials, to read as follows:


Sec. 171.7  Reference material.

    (a) * * *
    (3) Table of material incorporated by reference. * * *

------------------------------------------------------------------------
                                                              49 CFR
              Source and name of material                   reference
------------------------------------------------------------------------
 
      *         *         *         *         *         *         *
American Society for Testing and Materials
      *         *         *         *         *         *         *
ASTM D 1709-97 Standard Test Methods for Impact                  173.197
 Resistance of Plastic Film by the Free-Falling Dart
 Method, 1997 Edition..................................
      *         *         *         *         *         *         *
ASTM D 1922-94A Standard Test Method for Propagation             173.197
 Tear Resistance of Plastic Film and Thin Sheeting by
 Pendulum Method, 1994 edition.........................
      *         *         *         *         *         *         *
------------------------------------------------------------------------


[[Page 6953]]

* * * * *
    3. Section 171.8 would be amended by adding the following 
definitions in alphabetical order to read as follows:


Sec. 171.8  Definition and abbreviations.

* * * * *
    Biological product. See Sec. 173.134 of this subchapter.
* * * * *
    Cultures and stocks. See Sec. 173.134 of this subchapter.
* * * * *
    Diagnostic specimen. See Sec. 173.134 of this subchapter.
* * * * *
    Genetically modified micro-organism. See Sec. 173.140 of this 
subchapter.
* * * * *
    Risk group. See Sec. 173.134 of this subchapter.
* * * * *
    Sharps. See Sec. 173.134 of this subchapter.
* * * * *
    Toxin. See Sec. 173.134 of this subchapter.
* * * * *
    4. Section 171.14 would be amended by adding paragraph (f) to read 
as follows:


Sec. 171.14  Transitional provisions for implementing certain 
requirements.

* * * * *
    (f) Division 6.2 labels that conform to specifications in 
Sec. 172.432 of this subchapter in effect on October 1, 2000, may be 
used until [two years from the effective date of final rule].


Sec. 171.15  [Amended]

    5. In Sec. 171.15, the following changes would be made:
    a. Paragraph (a)(3) would be amended by removing the term 
``(etiologic agents)''.
    b. Paragraph (b) introductory text would be amended by removing the 
term ``etiologic agents'' and in its place adding the term ``infectious 
substances''.
    c. Paragraph (b) introductory text would be amended by adding the 
wording ``; however, a written report is still required as stated in 
paragraph (c) of this section'' immediately after the number ``202-267-
2675''.

PART 172--HAZARDOUS MATERIALS TABLE, SPECIAL PROVISIONS, HAZARDOUS 
MATERIALS COMMUNICATIONS, EMERGENCY RESPONSE INFORMATION, AND 
TRAINING REQUIREMENTS

    6. The authority citation for part 172 would continue to read as 
follows:

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

    7. In Sec. 172.101, the following proper shipping names would be 
added, in alphabetical order, or revised in the Hazardous Materials 
Table to read as follows:


Sec. 172.101  Purpose and use of hazardous materials table.

* * * * *

                                                        Sec.  172.101.--Hazardous Materials Table
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                     (8)  Packaging (Sec.  173.*     (9)  Quantity        (10)  Vessel
             Hazardous                                                                          * *)                  limitations           stowage
             materials      Hazard                                                 ---------------------------------------------------------------------
 Symbols    descriptions   class or  Identification     PG      Label     Special                                              Cargo
             and proper    division      Numbers                codes   provisions                Non-            Passenger    air-
           shipping names                                                           Exceptions    bulk     Bulk   aircraft/    craft   Location   Other
                                                                                                                     rail      only
(1)       (2)............       (3)  (4)             (5)           (6)  (7)              (8A)      (8B)     (8C)  (9A)       (9B)      (10A)       (10B)
--------------------------------------------------------------------------------------------------------------------------------------------------------
           [ADD]
          Diagnostic            6.2                  ........           A82               134       199     None  4L or 4kg  4L or     A              40
           specimen.                                                                                                          4kg
 
                   *                  *                  *                  *                  *                  *                  *
          Genetically             9  UN3245          ........        9  ..........        140       200     None  No Limit   No Limit  A              40
           modified micro-
           organisms.
 
                   *                  *                  *                  *                  *                  *                  *
G         Toxins, liquid,       6.1  UN3172          I             6.1  141                         201      243  1 L        30 L      B              40
           extracted from                            II                                             202      243  5 L        60 L      B              40
           living sources                            III                                  153       203      241  60 L       220 L     A              40
           n.o.s.
G         Toxins, solid,        6.1  UN3172          I             6.1  141                         211      243  5 kg       50 kg     B
           extracted from                            II                                             212      243  25 kg      100kg     B
           living sources                            III                                  153       213      241  100 kg     200kg     A
           n.o.s.
 
                   *                  *                  *                  *                  *                  *                  *
          [REVISE]
G         Infectious            6.2  UN2900                        6.2  A81, A82          134       196     None  50 ml or   4L or     B              40
           substances,                                                                                             50 g       4kg
           affecting
           animals only.
G         Infectious            6.2  UN2814                        6.2  A81, A82          134       196     None  50 ml or   4L or     B              40
           substances,                                                                                             50 g       4kg
           affecting
           humans.
 
                   *                  *                  *                  *                  *                  *                  *
          Regulated             6.2  UN3291          II            6.2  A13          134, 197       197      197  No Limit   No Limit  A              40
           medical waste.
 
                   *                  *                  *                  *                  *                  *                  *
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 6954]]

* * * * *
    8. In Sec. 172.102, in paragraph (c)(1), Special provision 141 
would be added, and in paragraph (c)(2), Special Provision A13 would be 
revised, Special provision A14 would be removed, and Special Provisions 
A81 and A82 would be added in alphanumeric order to read as follows:


Sec. 172.102  Special provisions.

* * * * *
    (c) * * *
    (1) * * *

Code/Special Provisions

* * * * *
    141  A toxin from a plant, animal or bacterial source that 
contains an infectious substance, or a toxin that is contained in an 
infectious substance, must be classed as Division 6.2 and assigned 
to UN 2814 or UN 2900, as appropriate.

    (2) * * *

Code/Special Provisions

* * * * *
    A13  Bulk packagings are not authorized for transportation by 
aircraft.
* * * * *
    A81  The quantity limits in columns (9A) and (9B) do not apply 
to blood or blood products known to contain or suspected of 
containing an infectious substance when transported in primary 
receptacles not exceeding 500 ml (17 ounces) and in outer packagings 
not exceeding 4 L (1 gallon) and packaged in accordance with 
Sec. 173.196 of this subchapter. A82 The quantity limits in columns 
(9A) and (9B) do not apply to human or animal body parts, whole 
organs or whole bodies known to contain or suspected of containing 
an infectious substance.

* * * * *
    9. A new Sec. 172.323 would be added to read as follows:


Sec. 172.323  Infectious substances.

    (a) In addition to any identification number required by this 
subpart, a bulk packaging containing a regulated medical waste, as 
defined in Sec. 173.134(a)(5) of this subchapter, must be marked with a 
BIOHAZARD marking that conforms to 29 CFR 1910.1030(g)(1)(i)--
    (1) On two opposing sides or two ends other than the bottom if the 
packaging has a capacity of less than 3,785 L (1,000 gallons). The 
BIOHAZARD marking must measure at least 273 mm (10.8 inches) on each 
side and must be visible from the direction it faces.
    (2) On each end and each side if the packaging has a capacity of 
3,785 L (1,000 gallons) or more. The BIOHAZARD marking must measure at 
least 273 mm (10.8 inches) on each side and must be visible from the 
direction it faces.
    (b) For a bulk packaging contained in or on a transport vehicle or 
freight container, if the BIOHAZARD marking on the bulk packaging is 
not visible, the transport vehicle or freight container must be marked 
as required by paragraph (a) of this section on each side and each end.
    10. In Sec. 172.432, the illustration in paragraph (a) would be 
revised to read as follows:


Sec. 172.432  INFECTIOUS SUBSTANCE label.

    (a) * * *
* * * * *
BILLING CODE 4910-60-P

[[Page 6955]]

[GRAPHIC] [TIFF OMITTED] TP22JA01.166

* * * * *

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

    11. The authority citation for part 173 would continue to read as 
follows:

    Authority: 49 U.S.C. 5101-5127, 44701; 49 CFR 1.45, 1.53.

    12. In Sec. 173.6, paragraph (a)(1) introductory text would be 
revised, paragraph (a)(4) would be redesignated as paragraph (a)(5), 
and a new paragraph (a)(4) would be added to read as follows:


Sec. 173.6  Materials of trade exceptions.

* * * * *
    (a) * * *
    (1) A Class 3, 8, 9, Division 4.1, 5.1, 5.2, 6.1, 6.2, or ORM-D 
material contained in a packaging having a gross mass or capacity not 
over--
* * * * *
    (4)(i) A Division 6.2 material, other than a Risk Group 4 material, 
that is a diagnostic specimen, biological product or regulated medical 
waste. The material must be contained in a combination packaging 
consisting of--
    (A) One or more inner packagings where the gross mass or capacity 
of each inner packaging does not exceed 0.5 kg (1.1 pound), or 0.5 L 
(17 ounces), and an outer packaging having a gross mass or capacity not 
exceeding 4 kg (8.8 pounds) or 4 L (1 gallon); or
    (B) A single inner packaging with a gross mass or capacity not 
exceeding 16 kg (35.2 pounds) or 16 L (4.2 gallons) in a single outer 
packaging.
    (ii) Regulated medical waste may be packaged in a combination 
packaging consisting of inner packagings having a gross mass or 
capacity not exceeding 4 kg (8.8 pounds) or 4 L (1 gallon), and an 
outer packaging having a gross mass or capacity not exceeding 16 kg 
(35.2 pounds) or 16 L (4.2 gallons). Packagings intended to contain 
sharps must be resistant to puncture and leak resistant.
* * * * *
    13. Section 173.28 would be amended by adding paragraph (f) to read 
as follows:


Sec. 173.28  Reuse, reconditioning and remanufacture of packagings.

* * * * *
    (f) A Division 6.2 packaging that is to be reused must be 
decontaminated prior to reuse by any means that is effective for 
neutralizing the infectious substance the packaging previously 
contained. A secondary packaging or outer packaging that conforms to 
the requirements of Sec. 173.196 or Sec. 173.199 need not be 
decontaminated prior to reuse if no leakage from the primary receptacle 
has occurred.
    14. Section 173.134 would be revised to read as follows:

[[Page 6956]]

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

    (a) Definitions and classification criteria. For the purpose of 
this subchapter, the following definitions and classification criteria 
apply:
    (1) Division 6.2 (infectious substance) means a material known to 
contain or suspected of containing a pathogen that has the potential to 
cause disease when exposure to it occurs. Pathogens are micro-organisms 
(including bacteria, viruses, rickettsia, parasites, and fungi) or 
recombinant micro-organisms (hybrid or mutant) that cause infectious 
disease in humans or animals. A Division 6.2 material must be assigned 
to a risk group in accordance with this paragraph (a). Assignment to UN 
2814 or UN 2900 is based on known medical condition and history of the 
source patient or animal, endemic local conditions, symptoms of the 
source patient or animal, or professional judgement concerning 
individual circumstances of the source patient or animal.
    (2) Biological product means:
    (i) A Division 6.2 material that is derived from a living organism 
that includes, but is not limited to, materials manufactured and 
distributed in accordance with one of the following provisions:
    (A) 9 CFR part 102 (Licenses for Biological Products);
    (B) 9 CFR part 103 (Experimental Products, Distribution, and 
Evaluation of Biological Products Prior to Licensing);
    (C) 9 CFR part 104 (Permits for Biological Products);
    (D) 21 CFR part 312 (Investigational New Drug Application); or
    (E) 21 CFR parts 600 to 680 (Biologics).
    (ii) A biological product is used for prevention, treatment, or 
diagnosis of disease in humans or animals, or for developmental, 
experimental, or investigational purposes related to these uses. This 
term includes a finished product such as a vaccine or an unfinished 
product intended for further processing into a finished product; 
however, it does not include a diagnostic specimen. Biological products 
known to contain or suspected of containing a pathogen in Risk Group 2, 
3, or 4 must be classed as Division 6.2 and described under UN 2814 or 
UN 2900, as appropriate, unless otherwise excepted.
    (3) Cultures and stocks means a material that is prepared and 
maintained for growth and storage and that contains a Risk Group 2, 3 
or 4 infectious substance.
    (4) Diagnostic specimen means any human or animal material, 
including excreta, secreta, blood and its components, tissue, and 
tissue fluids being transported for diagnostic or investigational 
purposes, but excluding live infected humans or animals. A diagnostic 
specimen is not assigned a UN identification number unless the source 
patient or animal has or may have a serious human or animal disease 
from a Risk Group 4 micro-organism, in which case it must be assigned 
to UN 2814 or UN 2900, as appropriate. Assignment to UN 2814 or UN 2900 
is based on known medical condition and history of the patient or 
animal, endemic local conditions, symptoms of the source patient or 
animal, or professional judgement concerning individual circumstances 
of the source patient or animal.
    (5) Regulated medical waste means a waste or reusable material that 
contains or is suspected of containing an infectious substance in Risk 
Group 2 or 3 and is generated in the diagnosis, treatment, or 
immunization of human beings or animals; research on the diagnosis, 
treatment or immunization of human beings or animals; or the production 
or testing of biological products. Regulated medical waste containing 
an infectious substance in Risk Group 4 must be classed as Division 6.2 
and described under UN 2814 or UN 2900, as appropriate.
    (6) Risk group means a ranking of a micro-organism's ability to 
cause injury through disease. A risk group is defined by criteria 
developed by the World Health Organization (WHO) based on the 
pathogenicity of the organism, the mode and relative ease of 
transmission, the degree of risk to both an individual and a community, 
and the reversibility of the disease through the availability of known 
and effective preventative agents and treatment. There is no 
relationship between a risk group and a packing group. The criteria for 
each risk group according to the level of risk are as follows:

                                                Risk Group Table
----------------------------------------------------------------------------------------------------------------
    Risk  group                      Pathogen                    Risk to individuals      Risk to the community
----------------------------------------------------------------------------------------------------------------
4..................  A pathogen that usually causes serious   HIGH                      HIGH
                      human or animal disease and that can
                      be readily transmitted from one
                      individual to another, directly or
                      indirectly, and for which effective
                      treatments and preventive measures are
                      not usually available.
3..................  A pathogen that usually causes serious   HIGH                      LOW
                      human or animal disease but does not
                      ordinarily spread from one infected
                      individual to another, and for which
                      effective treatments and preventive
                      measures are available.
2..................  A pathogen that can cause human or       MODERATE                  LOW
                      animal disease but is unlikely to be a
                      serious hazard, and, while capable of
                      causing serious infection on exposure,
                      for which there are effective
                      treatments and preventive measures
                      available and the risk of spread of
                      infection is limited.
1..................  A micro-organism that is unlikely to     NONE OR VERY LOW          NONE OR VERY LOW
                      cause human or animal disease. A
                      material containing only such micro-
                      organisms is not subject to the
                      requirements of this subchapter.
----------------------------------------------------------------------------------------------------------------

    (7) Sharps means any object that may be contaminated with a 
pathogen that is also capable of cutting or penetrating skin or a 
packaging material. The term includes needles, scalpels, broken glass, 
culture slides, culture dishes, broken capillary tubes, broken rigid 
plastic, and exposed ends of dental wires.
    (8) Toxin means a Division 6.1 material secreted from a plant, 
animal, or bacterial source. A toxin that contains an infectious 
substance or a toxin that is contained in an infectious substance must 
be classed as Division 6.2 and described under UN 2814 or UN 2900, as 
appropriate.
    (b) Exceptions. The following are not subject to the requirements 
of this subchapter as Division 6.2 materials:
    (1) Biological products that are known to contain or suspected of 
containing a pathogen in Risk Group 1, or that do not contain a 
pathogen.
    (2) Biological products that have successfully completed all 
applicable

[[Page 6957]]

federal approval or licensing requirements, such as those required by 
the Food and Drug Administration of the Department of Health and Human 
Services or the U.S. Department of Agriculture.
    (3) Blood that has been collected for the purpose of blood 
transfusion or for the preparation of blood products, and blood 
products, tissues, or organs intended for use in transplant operations.
    (4) A diagnostic specimen or biological product when transported by 
a private or contract carrier in a motor vehicle used exclusively to 
transport diagnostic specimens or biological products. Medical or 
clinical equipment and laboratory products may be transported aboard 
the same vehicle provided they are properly packaged and secured 
against exposure/contamination to the diagnostic specimen. If a 
diagnostic specimen or biological product meets the definition of 
regulated medical waste in paragraph (a)(5) of this section, it must be 
offered for transportation and transported in conformance with the 
appropriate requirements for regulated medical waste.
    (5) Laundry or medical equipment that conforms to the regulations 
of the Occupational Safety and Health Administration of the Department 
of Labor in 29 CFR 1910.1030. This exception includes medical equipment 
that is intended for use, cleaning, or refurbishment, such as reusable 
surgical equipment, or equipment used for testing where the components 
within which the equipment is contained essentially function as 
packaging. This exception does not apply to medical equipment that is 
being transported for disposal.
    (6) A material, including waste, that previously contained an 
infectious substance that has been treated by steam sterilization, 
chemical disinfection, or other appropriate method, so that it no 
longer meets the definition of an infectious substance.
    (7) A living person.
    (8) Any waste or recyclable material, other than regulated medical 
waste, including--
    (i) Garbage and trash derived from hotels, motels, and households, 
including but not limited to single and multiple residences;
    (ii) Sanitary waste or sewage;
    (iii) Sewage sludge or compost;
    (iv) Animal waste generated in animal husbandry or food production; 
or
    (v) Medical waste generated from households and transported in 
accordance with applicable state, local, or tribal requirements.
    (9) Corpses, remains, and anatomical parts that are intended for 
interment, cremation, or medical research at a college, hospital, or 
laboratory.
    (10) Forensic material that is transported on behalf of a U.S. 
Government, state, local or Indian tribal government agency. The 
material must be shipped in a packaging conforming to the provisions of 
Sec. 173.24.
    (c) Exceptions for regulated medical waste. The following 
provisions apply to the transportation of regulated medical waste:
    (1) A regulated medical waste that is transported by a private or 
contract carrier is excepted from--
    (i) The requirement for an ``INFECTIOUS SUBSTANCE'' label if the 
outer packaging is marked with a ``BIOHAZARD'' marking in accordance 
with 29 CFR 1910.1030; and
    (ii) For other than a waste culture or stock of an infectious 
substance, the specific packaging requirements of this section if 
packaged in a rigid non-bulk packaging conforming to the general 
packaging requirements of Secs. 173.24 and 173.24a and packaging 
requirements specified in 29 CFR 1910.1030.
    (2) A waste culture or stock of a Risk Group 2 or 3 infectious 
substance may be offered for transportation and transported as a 
regulated medical waste when it is packaged in a rigid non-bulk 
packaging conforming to the general packaging requirements of 
Secs. 173.24 and 173.24a and packaging requirements specified in 29 CFR 
1910.1030 and transported by a private or contract carrier using a 
vehicle dedicated to the transportation of regulated medical waste.
    (d) If an item listed in paragraph (b) or (c) of this section meets 
the definition of another hazard class or if it is a hazardous 
substance, hazardous waste, or marine pollutant, it must be offered for 
transportation and transported in accordance with applicable 
requirements of this subchapter.
    15. Section 173.140 would be amended by removing ``; or'' at the 
end of paragraph (a) and adding a period in its place and by adding 
paragraphs (c) and (d) to read as follows:


Sec. 173.140  Class 9-Definitions.

* * * * *
    (c) Genetically modified micro-organism. A genetically modified 
micro-organism is a micro-organism that has been purposely altered 
through genetic engineering in a way that does not occur naturally.
    (1) A Class 9 genetically modified micro-organism does not meet the 
definition of a Division 6.2 material, but has the potential to alter 
animals, plants or microbiological substances in a way not normally the 
result of natural reproduction.
    (2) A genetically modified micro-organism that also meets the 
definition for a Division 6.2 material must be classed as a Division 
6.2 material.
    (3) A live animal that contains, or is contaminated with, a 
genetically modified micro-organism, including a genetically modified 
micro-organism that also meets the definition of a Division 6.2 
material, must be transported under terms and conditions approved by 
the Associate Administrator for Hazardous Materials Safety.
    (4) A genetically modified micro-organism known or suspected to be 
dangerous to the environment may not be transported by air unless 
approved by the Associate Administrator for Hazardous Materials Safety.
    (d) Exceptions for genetically modified micro-organisms. (1) A 
genetically modified micro-organism that is authorized by a U.S. 
Government agency for final distribution and use is not subject to 
requirements of this subchapter.
    (2) A genetically modified micro-organism is excepted from all 
other requirements of this subchapter when transported in a non-
passenger carrying transport vehicle operated by a private or contract 
motor carrier. The material must be packaged in accordance with the 
provisions in Sec. 173.203 or Sec. 173.213 at the Packing Group III 
performance level, and marked with the proper shipping name 
``Genetically modified micro-organism''. Each person who offers or 
transports a genetically modified micro-organism under the provisions 
of this paragraph (d) must be informed of the requirements of this 
paragraph (d).
    16. Section 173.196 would be revised to read as follows:


Sec. 173.196  Infectious substances.

    (a) Division 6.2 packaging. A Division 6.2 packaging must meet the 
test standards of Sec. 178.609 of this subchapter and must be marked in 
conformance with Sec. 178.503(f) of this subchapter. Division 6.2 
packaging is a triple packaging that consists of the following 
components:
    (1) A watertight primary receptacle.
    (2) A watertight secondary packaging. If multiple primary 
receptacles are placed in a single secondary packaging, they must be 
wrapped individually to prevent contact between them.
    (3) An outer packaging of adequate strength for its capacity, mass 
and intended use. The outer packaging must

[[Page 6958]]

measure at least 100 mm (3.9 inches) at its smallest overall external 
dimension.
    (4) For a liquid infectious substance, an absorbent material placed 
between the primary receptacle and the secondary packaging. The 
absorbent material must be sufficient to absorb the entire contents of 
all primary receptacles.
    (5) An itemized list of contents enclosed between the secondary 
packaging and the outer packaging.
    (6) The primary receptacle or secondary packaging used for 
infectious substances must be capable of withstanding, without leakage, 
an internal pressure that produces a pressure differential of not less 
than 95 kPa (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).
    (b) Additional requirements for packaging infectious substances. 
Infectious substances must be packaged according to the following 
requirements depending on the physical state and other characteristics 
of the material:
    (1) Infectious lyophilized substances. Primary receptacles must be 
flame-sealed glass ampules or rubber-stopped glass vials fitted with 
metal seals.
    (2) Liquid or solid infectious substances--(i) Infectious 
substances shipped at ambient temperatures or higher. Authorized 
primary receptacles are those of glass, metal, or plastic. Positive 
means of ensuring a leakproof seal, such as heat seal, skirted stopper, 
or metal crimp seal, must be provided. If screw caps are used, they 
must be secured by positive means, such as with adhesive tape.
    (ii) Infectious substances shipped refrigerated or frozen (ice, 
pre-frozen packs, dry ice). Ice or dry ice must be placed outside the 
secondary packagings or in an overpack with one or more complete 
packages marked in accordance with Sec. 178.503 of this subchapter. 
Interior supports must be provided to secure the secondary packagings 
in the original position after the ice or dry ice has dissipated. If 
ice is used, the outside packaging must be leakproof. If dry ice is 
used, the outside packaging must permit the release of carbon dioxide 
gas and otherwise meet the provisions in Sec. 173.217. The primary 
receptacle and the secondary packaging must maintain their integrity at 
the temperature of the refrigerant used as well as the temperatures and 
pressures of air transport to which they could be subjected if 
refrigeration were lost.
    (iii) Infectious substances shipped in liquid nitrogen. Primary 
receptacles capable of withstanding very low temperatures must be used. 
Secondary packaging must withstand very low temperatures and in most 
cases will need to be fitted over individual primary receptacles. The 
primary receptacle and the secondary packaging must maintain their 
integrity at the temperature of the liquid nitrogen as well as the 
temperatures and pressures of air transport to which they could be 
subjected if refrigeration were to be lost. Refrigerated liquid 
nitrogen packagings must be metal vacuum insulated vessels or flasks 
(also called ``dry shippers'') vented to the atmosphere to prevent any 
increase in pressure within the packaging. The use of safety relief 
valves, check valves, frangible discs, or similar devices in the vent 
lines is prohibited. Fill and discharge openings must be protected 
against the entry of foreign materials that might cause an increase in 
the internal pressure. The package orientation markings specified in 
Sec. 172.312(b) of this subchapter must be marked on the packaging. The 
packaging must be designed to prevent the release of any refrigerated 
liquid nitrogen irrespective of the packaging orientation.
    (c) Live animals may not be used to transport infectious substances 
unless such substances cannot be sent by any other means. An animal 
that contains or is contaminated with an infectious substance must be 
transported under terms and conditions approved by the Associate 
Administrator for Hazardous Materials Safety.
    (d) Body parts, organs or whole bodies meeting the definition of 
Division 6.2 material must be packaged as follows:
    (1) In Division 6.2 packaging, as specified in paragraphs (a) and 
(b) of this section; or
    (2) In packaging that meets the requirements of Sec. 173.197(a).
    17. Section 173.197 would be revised to read as follows:


Sec. 173.197  Regulated medical waste.

    (a) General provisions. Non-bulk and bulk packagings used for the 
transportation of regulated medical waste must be rigid containers that 
meet the provisions of subpart B of this part. The packaging must be 
puncture-resistant for sharps and sharps with residual fluid as 
demonstrated by conducting the performance tests in part 178, subpart 
M, of this subchapter on packagings containing materials representative 
of the sharps and fluids (such as sterile sharps) that are intended to 
be transported in the packagings.
    (b) Non-bulk packagings. Except as otherwise provided in this 
subchapter, non-bulk packagings for regulated medical waste must 
conform to the requirements of part 178 of this subchapter at the 
Packing Group II performance level.
    (c) Large packagings. Large Packagings constructed, tested, and 
marked in accordance with the requirements of the UN Recommendations 
and conforming to other requirements of this paragraph (c) may be used 
for the transportation of regulated medical waste, provided that the 
inner packagings conform to the requirements of paragraph (e) of this 
section. Each Large Packaging must be capable of meeting the vibration 
test specified in Sec. 178.819 of this subchapter. Each Large Packaging 
is subject to the periodic design requalification requirements for 
intermediate bulk containers in Sec. 178.801(e) of this subchapter and 
to the proof of compliance requirements of Sec. 178.801(j) and record 
retention requirements of Sec. 178.801(l) of this subchapter. Inner 
packagings used for liquids must be rigid.
    (1) Authorized packagings. The following Large Packagings are 
authorized for the transportation of liquid or solid regulated medical 
waste:
    (i) Metal: 50A, 50B, or 50N.
    (ii) Rigid plastic: 50H.
    (2) Additional requirements. Each Large Packaging used to transport 
liquid regulated medical waste must contain absorbent material in 
sufficient quantity and appropriate location to absorb the entire 
amount of liquid present in the event of an unintentional release of 
contents. Each Large Packaging intended for the transportation of 
sharps containers must be puncture resistant and capable of retaining 
liquids and must meet the performance tests specified for intermediate 
bulk containers intended for the transportation of liquids in subpart O 
of part 178 of this subchapter.
    (d) Non-specification bulk packaging. A wheeled cart (CART) or bulk 
outer packaging (BOP) is authorized as an outer packaging for the 
transportation of regulated medical waste in accordance with the 
provisions of this paragraph (d).
    (1) General requirements. The following requirements apply to the 
transportation of regulated medical waste in CARTs or BOPs:
    (i) Each CART or BOP must have non-bulk inner packagings that 
conform to paragraph (e) of this section.
    (ii) Each CART or BOP must have interior surfaces that are smooth, 
non-porous, and free of cracks, crevices, and other defects that could 
damage inner packagings or impede decontamination operations.
    (iii) Except as otherwise provided in this paragraph (d), each CART 
or BOP

[[Page 6959]]

must be used exclusively for the transportation of regulated medical 
waste. Prior to reuse, each CART or BOP must be decontaminated by any 
means that is effective for neutralizing the infectious substance the 
packaging previously contained.
    (iv) Untreated cultures and stocks of infectious substances that 
contain Risk Group 4 materials may not be transported in a CART or BOP.
    (v) Division 6.1 toxic waste or Class 7 radioactive waste, with the 
exception of materials that are chemotherapeutic waste, may not be 
transported in a CART or BOP.
    (vi) Division 6.1 or Class 7 chemotherapeutic waste; untreated 
stocks and cultures of infectious substances that contain Risk Group 2 
or 3 pathogenic organisms; unabsorbed liquids; and sharps containers 
may be transported in a CART or BOP only if packaged in rigid non-bulk 
packagings that conform to paragraph (a) of this section.
    (2) Wheeled cart (CART). A CART is authorized as an outer packaging 
for the transportation of regulated medical waste if it conforms to the 
following requirements:
    (i) Each CART must consist of a solid, one-piece body, mounted on a 
minimum of four (4) fixed wheels, with a nominal volume that does not 
exceed 1,655 liters (437 gallons).
    (ii) Each CART must be constructed of metal, rigid plastic, or 
fiberglass with a hinged and gasketed lid that, when closed, prevents 
leakage during transport.
    (iii) Each CART must be capable of meeting the requirements of 
Sec. 178.603 (drop test), as specified for solids at the Packing Group 
II performance level.
    (iv) Inner packagings must be placed into a CART and restrained in 
such a manner as to minimize the risk of breakage.
    (3) Bulk outer packaging (BOP). A BOP is authorized as an outer 
packaging for regulated medical waste if it conforms to the following 
requirements:
    (i) Each BOP must be constructed of metal or fiberglass and have a 
capacity of at least 3.5 cubic meters (123.6 cubic feet) and not more 
than 45 cubic meters (1,590 cubic feet).
    (ii) Each BOP must have bottom and side joints of fully welded or 
seamless construction and a rigid, weatherproof top that prevents the 
intrusion of water (e.g., rain or snow).
    (iii) Each opening in a BOP must be fitted with a closure that 
prevents the intrusion of water or the release of any liquid during all 
loading, unloading, and transportation operations.
    (iv) In the upright position, each BOP must be leakproof and able 
to contain a liquid quantity of at least 300 liters (79.2 gallons) with 
closures open.
    (v) Inner packagings must be placed in a BOP in such a manner as to 
minimize the risk of breakage. Rigid inner packagings may not be placed 
in the same BOP with plastic film bag inner packagings unless separated 
from each other by rigid barriers or dividers that prevent damage to 
the packagings caused by load shifting during normal conditions of 
transportation.
    (vi) Division 6.1 or Class 7 chemotherapeutic waste, untreated 
cultures and stocks of infectious substances that contain Risk Group 2 
or 3 pathogenic organisms, unabsorbed liquids, and sharps may be 
transported in a BOP only if separated and secured as provided by 
paragraph (d)(3)(v) of this section.
    (e) Inner packagings authorized for Large Packagings, CARTs, and 
BOPs. Inner packagings must be durably marked or tagged with the name 
and location (city and state) of the offeror, except when the entire 
contents of the Large Packaging, CART, or BOP originates at a single 
location and is delivered to a single location.
    (1) Solids. A plastic film bag is authorized as an inner packaging 
for solid regulated medical waste transported in a CART, Large 
Packaging, or BOP. Waste material containing absorbed liquid may be 
packaged as a solid in a plastic film bag if the bag contains 
sufficient absorbent material to absorb and retain all liquid during 
transportation.
    (i) The film bag may not exceed a volume of 175 L (46 gallons). The 
film bag must be marked and certified by its manufacturer as having 
passed the tests prescribed for tear resistance in ASTM D 1709-97, 
Standard Test Methods for Impact Resistance of Plastic Film by the 
Free-Falling Dart Method, 1997 Edition, and for impact resistance in 
ASTM D 1922-94A, Standard Test Method for Propagation Tear Resistance 
of Plastic Film and Thin Sheeting by Pendulum Method, 1994 edition. The 
film bag must meet an impact resistance of 165 grams and a tearing 
resistance of 480 grams in both the parallel and perpendicular planes 
with respect to the length of the bag.
    (ii) The plastic film bag must be closed with a minimum of 
entrapped air to prevent leakage in transportation. The bag must be 
capable of being held in an inverted position with the closed end at 
the bottom for a period of 5 minutes without leakage.
    (iii) When used as an inner packaging for CARTs or BOPs, a plastic 
film bag may not weigh more than 10 kg (22 lbs.) when filled.
    (2) Liquids. Liquid regulated medical waste that is transported in 
a Large Packaging, CART, or BOP must be packaged in a rigid inner 
packaging that conforms to the requirements of paragraph (a) of this 
section. Liquid materials are not authorized for transportation in 
inner packagings larger than 19 L (5 gallons).
    (3) Sharps. Sharps that are transported in a Large Packaging, CART, 
or BOP must be packaged in a puncture-resistant inner packaging (sharps 
container). Each inner packaging may not exceed 38 L (10 gallons) in 
volume.
    18. A new Sec. 173.199 would be added to read as follows:


Sec. 173.199  Diagnostic specimens and used health care products.

    (a) Diagnostic specimens. Diagnostic specimens are excepted from 
other requirements of this subchapter when offered for transportation 
or transported in accordance with this section. Diagnostic specimens 
offered for transportation or transported by aircraft under the 
provisions of this section are subject to the incident reporting 
requirements in Secs. 171.15 and 171.16 of this subchapter. A 
diagnostic specimen that meets the definition of a hazard class other 
than Division 6.2 must be offered for transportation or transported in 
accordance with applicable requirements of this subchapter.
    (1) Diagnostic specimens must be packaged in a triple packaging, 
consisting of a primary receptacle, a secondary packaging, and an outer 
packaging.
    (2) Primary receptacles must be packed in secondary packaging in 
such a way that, under normal conditions of transport, they cannot 
break, be punctured, or leak their contents into the secondary 
packaging.
    (3) Secondary packagings must be secured in outer packagings with 
suitable cushioning material such that any leakage of the contents will 
not impair the protective properties of the cushioning material or the 
outer packaging.
    (4) The completed package must be capable of successfully passing 
the drop test in Sec. 178.603 of this subchapter at a drop height of at 
least 1.2 meters (3.9 feet). Each package must be clearly and durably 
marked with the words ``Diagnostic Specimen.''
    (b) Liquid diagnostic specimens. Liquid diagnostic specimens must 
be packaged in conformance with the following provisions:

[[Page 6960]]

    (1) The primary receptacle must be leakproof with a volumetric 
capacity of not more than 500 ml (16.9 ounces).
    (2) Absorbent material must be placed between the primary 
receptacle and secondary packaging. If several fragile primary 
receptacles are placed in a single secondary packaging, they must be 
individually wrapped or separated so as to prevent contact between 
them. The absorbent material must be of sufficient quantity to absorb 
the entire contents of the primary receptacles.
    (3) The secondary packaging must be leakproof.
    (4) For shipments by aircraft, the primary receptacle or the 
secondary packaging must be capable of withstanding without leakage an 
internal pressure producing a pressure differential of not less than 95 
kPa (0.95 bar, 14 psi).
    (5) The outer packaging may not exceed 4 L (1 gallon) capacity.
    (c) Solid diagnostic specimens. Solid diagnostic specimens must be 
packaged in a triple packaging, consisting of a primary receptacle, 
secondary packaging, and outer packaging, that conforms to the 
following provisions:
    (1) The primary receptacle must be siftproof with a capacity of not 
more than 500 g (1.1 pounds).
    (2) If several fragile primary receptacles are placed in a single 
secondary packaging, they must be individually wrapped or separated so 
as to prevent contact between them.
    (3) The secondary packaging must be siftproof.
    (4) The outer packaging may not exceed 4 kg (8.8 pounds) capacity.
    (d) Used health care products. Used health care products are 
medical, diagnostic, or research devices and equipment, and personal 
care products used by consumers, medical professionals, or 
pharmaceutical providers that may be contaminated with an infectious 
substance but do not meet the definition of a diagnostic specimen, 
biological product, or regulated medical waste. Used health care 
products being returned to the manufacturer are excepted from the 
requirements of this subchapter when offered for transportation or 
transported in accordance with this section. For purposes of this 
section, a health care product is used when it has been removed from 
its original inner packaging. Used health care products contaminated 
with or suspected of contamination with a Risk Group 4 infectious 
substance may not be transported under the provisions of this section.
    (1) Each used health care product must be drained of free liquid to 
the extent practicable and placed in a watertight metal or plastic 
primary container. The primary container must be designed and 
constructed in such a manner as to assure that it remains intact under 
conditions normally incident to transportation. Each primary container 
used to transport a used health care product that is capable of cutting 
or penetrating skin or packaging material must be capable of retaining 
the product without puncture of the packaging under normal conditions 
of transport. Each primary container must be marked with a BIOHAZARD 
marking that conforms to 29 CFR 1910.1030(g)(1)(i).
    (2) Each primary container must be placed inside a watertight metal 
or plastic secondary container. The secondary container must be 
designed and constructed in such a manner as to assure that it remains 
intact under conditions normally incident to transportation. The 
secondary container must be marked with a BIOHAZARD marking that 
conforms to 29 CFR 1910.1030(g)(1)(i).
    (3) The secondary container must be placed inside an outer 
packaging with sufficient cushioning material to prevent movement 
between the secondary container and the outer packaging. An itemized 
list of the contents of the primary container and information 
concerning possible contamination with a Division 6.2 material, 
including its possible location on the product, must be placed between 
the secondary container and the outside packaging.
    (e) Training. Each person who offers or transports a diagnostic 
specimen or used health care product under the provisions of this 
section must be informed of the requirements of this section.
    19. A new Sec. 173.200 would be added to read as follows:


Sec. 173.200  Genetically modified micro-organisms.

    A genetically modified micro-organism must be packaged as follows:
    (a) In accordance with the provisions in Sec. 173.203 or 
Sec. 173.213 for liquids or solids, respectively, at the Packing Group 
III performance level; or
    (b) In accordance with the provisions of Sec. 173.196(a), except 
that the completed package is not subject to the test requirements in 
Sec. 178.609 of this subchapter.

PART 177--CARRIAGE BY PUBLIC HIGHWAY

    20. The authority citation for part 177 would continue to read as 
follows:

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

    21. In Sec. 177.834, paragraphs (a) and (g) would be revised to 
read as follows:


Sec. 177.834  General requirements.

    (a) Packages secured in a vehicle. Any tank, barrel, drum, 
cylinder, or other packaging not permanently attached to a motor 
vehicle that contains any Class 2 (gases), Class 3 (flammable liquid), 
Division 6.1 (poisonous), Division 6.2 (infectious substance), Class 7 
(radioactive), or Class 8 (corrosive) material must be secured against 
movement within the vehicle on which it is being transported, under 
conditions normally incident to transportation.
* * * * *
    (g) Prevent relative motion between containers. Containers of Class 
1 (explosive), Class 2 (gases), Class 3 (flammable liquid), Class 4 
(flammable solid), Class 5 (oxidizing), Division 6.1 (poisonous), 
Division 6.2 (infectious substance), or Class 8 (corrosive) materials 
must be so braced as to prevent motion thereof relative to the vehicle 
while in transit. Containers having valves or other fittings must be so 
loaded that there will be the minimum likelihood of damage thereto 
during transportation.
* * * * *
    22. In Sec. 177.843, new paragraph (d) would be added to read as 
follows:


Sec. 177.843  Contamination of vehicles.

* * * * *
    (d) Each transport vehicle used to transport Division 6.2 materials 
must be decontaminated prior to reuse if a Division 6.2 material is 
released from its packaging during transportation. Decontamination may 
be by any means that is effective for neutralizing the material 
released.

PART 178--SPECIFICATIONS FOR PACKAGINGS

    23. The authority citation for part 178 would continue to read as 
follows:

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

    24. In Sec. 178.503, paragraph (f) would be added to read as 
follows:


Sec. 178.503  Marking of packagings.

* * * * *
    (f) A manufacturer must mark every UN specification package that is 
represented as manufactured to meet the requirements of Sec. 178.609 
for packaging of infectious substances with the marks specified in this 
section. The markings must be durable, legible, and must be readily 
visible, as specified in Sec. 178.3(a). An infectious substance 
packaging that

[[Page 6961]]

successfully passes the tests conforming to the UN standard must be 
marked as follows:
    (1) The United Nations symbol as illustrated in paragraph (e) of 
this section.
    (2) The code designating the type of packaging and material of 
construction according to the identification codes for packagings 
specified in Sec. 178.502.
    (3) The text ``CLASS 6.2''.
    (4) The last two digits of the year of manufacture of the 
packaging.
    (5) The country authorizing the allocation of the mark. The letters 
``USA'' indicate that the packaging is manufactured and marked in the 
United States in compliance with the provisions of this subchapter.
    (6) The name and address or symbol of the manufacturer or the 
approval agency certifying compliance with subparts L and M of this 
part. Symbols, if used, must be registered with the Associate 
Administrator for Hazardous Materials Safety.
    (7) For packagings meeting the requirements of Sec. 178.609(i)(3), 
the letter ``U'' must be inserted immediately following the marking 
designating the type of packaging and material required in paragraph 
(f)(2) of this section.
    25. In Sec. 178.601, paragraphs (c)(1), (c)(2), and (e) would be 
revised to read as follows:


Sec. 178.601  General requirements.

* * * * *
    (c) * * *
    (1) Design qualification testing is the performance of the tests 
prescribed in Sec. 178.603, Sec. 178.604, Sec. 178.605, Sec. 178.606, 
Sec. 178.607, Sec. 178.608, or Sec. 178.609, as applicable, for each 
new or different packaging, at the start of production of that 
packaging.
    (2) Periodic retesting is the performance of the drop, 
leakproofness, hydrostatic pressure, and stacking tests, as applicable, 
as prescribed in Sec. 178.603, Sec. 178.604, Sec. 178.605, or 
Sec. 178.606, respectively, at the frequency specified in paragraph (e) 
of this section. For infectious substances packagings that are required 
to meet the requirements of Sec. 178.609, periodic retesting is the 
performance of the tests specified in Sec. 178.609 at the frequency 
specified in paragraph (e) of this section.
* * * * *
    (e) Periodic retesting. The packaging manufacturer must achieve 
successful test results for the periodic retesting at intervals 
established by the manufacturer of sufficient frequency to ensure that 
each packaging produced by the manufacturer is capable of passing the 
design qualification tests. Changes in retest frequency are subject to 
the approval of the Associate Administrator for Hazardous Materials 
Safety. For single or composite packagings, the periodic retests must 
be conducted at least once every 12 months. For combination packagings, 
the periodic retests must be conducted at least once every 24 months. 
For infectious substances packagings, the periodic retests must be 
conducted at least once every 24 months.
* * * * *
    26. In Sec. 178.609, the section heading, paragraph (c) preceding 
the table, the introductory text of paragraph (d)(1), paragraphs 
(d)(1)(i), (d)(1)(iii), (d)(1)(iv), (e), (h)(1), (h)(2), and (i) would 
be revised to read as follows:


Sec. 178.609  Test requirements for packagings for infectious 
substances.

* * * * *
    (c) Packagings prepared as for transport must be subjected to the 
tests in Table I of this paragraph (c), which, for test purposes, 
categorize packagings according to their material characteristics. For 
outer packagings, the headings in Table I relate to fiberboard or 
similar materials whose performance may be rapidly affected by 
moisture; plastics, which may embrittle at low temperature; and other 
materials, such as metal, for which performance is not significantly 
affected by moisture or temperature. Where a primary receptacle and a 
secondary packaging of an inner packaging are made of different 
materials, the material of the primary receptacle determines the 
appropriate test. In instances where a primary receptacle is made of 
more than one material, the material most likely to be damaged 
determines the appropriate test.
* * * * *
    (d) * * *
    (1) Where the samples are in the shape of a box, five must be 
dropped in sequence:
    (i) Flat on the base;
    (ii) * * *
    (iii) Flat on the longest side;
    (iv) Flat on the shortest side; and * * * * *
    (e) The samples must be subjected to a water spray that simulates 
exposure to rainfall of approximately 50 mm (2 inches) per hour for at 
least one hour. They must then be subjected to the test described in 
paragraph (d) of this section.
* * * * *
    (h) * * *
    (1) Samples must be placed on a level, hard surface. A cylindrical 
steel rod with a mass of at least 7 kg (15 pounds), a diameter not 
exceeding 38 mm (1.5 inches), and, at the impact end edges, a radius 
not exceeding 6 mm (0.2 inches), must be dropped in a vertical free 
fall from a height of 1 m (3 feet), measured from the impact end of the 
sample's impact surface. One sample must be placed on its base. A 
second sample must be placed in an orientation perpendicular to that 
used for the first. In each instance, the steel rod must be aimed to 
impact the primary receptacle(s). There must be no leakage from the 
primary receptacle(s) following each impact.
    (2) Samples must be dropped onto the end of a cylindrical steel 
rod. The rod must be set vertically in a level, hard surface. It must 
have a diameter of 38 mm (1.5 inches) and a radius not exceeding 6 mm 
(0.2 inches) at the edges of the upper end. The rod must protrude from 
the surface a distance at least equal to that between the primary 
receptacle(s) and the outer surface of the outer packaging with a 
minimum of 200 mm (7.9 inches). One sample must be dropped in a 
vertical free fall from a height of 1 m (3 feet), measured from the top 
of the steel rod. A second sample must be dropped from the same height 
in an orientation perpendicular to that used for the first. In each 
instance, the packaging must be oriented so that the steel rod will 
impact the primary receptacle(s). There must be no leakage from the 
primary receptacle(s) following each impact.
    (i) Variations. The following variations in the primary receptacles 
placed within the secondary packaging are allowed without additional 
testing of the completed package. An equivalent level of performance 
must be maintained.
    (1) Variation 1. Primary receptacles of equivalent or smaller size 
as compared to the tested primary receptacles may be used provided they 
meet all of the following conditions:
    (i) The primary receptacles are of similar design to the tested 
primary receptacle (e.g., shape: round, rectangular, etc.).
    (ii) The material of construction of the primary receptacle (glass, 
plastics, metal, etc.) offers resistance to impact and a stacking force 
equal to or greater than that of the originally tested primary 
receptacle.
    (iii) The primary receptacles have the same or smaller openings and 
the closure is of similar design (e.g., screw cap, friction lid, etc.).
    (iv) Sufficient additional cushioning material is used to fill void 
spaces and to prevent significant movement of the primary receptacles.

[[Page 6962]]

    (v) Primary receptacles are oriented within the intermediate 
packaging in the same manner as in the tested package.
    (2) Variation 2. A lesser number of the tested primary receptacles, 
or of the alternative types of primary receptacles identified in 
paragraph (i)(1) of this section, may be used provided sufficient 
cushioning is added to fill the void space(s) and to prevent 
significant movement of the primary receptacles.
    (3) Variation 3. Primary receptacles of any type may be placed 
within a secondary packaging and shipped without testing in the outer 
packaging provided all of the following conditions are met:
    (i) The secondary and outer packaging combination must be 
successfully tested in accordance with paragraphs (a) through (h) of 
this section with fragile (e.g., glass) inner receptacles.
    (ii) The total combined gross weight of inner receptacles may not 
exceed one-half the gross weight of inner receptacles used for the drop 
test in paragraph (d) of this section.
    (iii) The thickness of cushioning material between inner 
receptacles and between inner receptacles and the outside of the 
secondary packaging may not be reduced below the corresponding 
thicknesses in the originally tested packaging. If a single inner 
receptacle was used in the original test, the thickness of cushioning 
between the inner receptacles must be no less than the thickness of 
cushioning between the outside of the secondary packaging and the inner 
receptacle in the original test. When either fewer or smaller inner 
receptacles are used (as compared to the inner receptacles used in the 
drop test), sufficient additional cushioning material must be used to 
fill the void.
    (iv) The outer packaging must pass the stacking test in 
Sec. 178.606 while empty. The total weight of identical packages must 
be based on the combined mass of inner receptacles used in the drop 
test in paragraph (d) of this section.
    (v) For inner receptacles containing liquids, an adequate quantity 
of absorbent material must be present to absorb the entire liquid 
contents of the inner receptacles.
    (vi) If the outer packaging is intended to contain inner 
receptacles for liquids and is not leakproof, or is intended to contain 
inner receptacles for solids and is not sift proof, a means of 
containing any liquid or solid contents in the event of leakage must be 
provided. This can be a leakproof liner, plastic bag, or other equally 
effective means of containment.
    (vii) In addition, the marking required in Sec. 178.503(f) of this 
subchapter must be followed by the letter ``U''.

    Issued in Washington, D.C., on December 27, 2000, under 
authority delegated in 49 CFR part 106.
Robert A. McGuire,
Associate Administrator for Hazardous Materials Safety, Research and 
Special Programs Administration.
[FR Doc. 01-92 Filed 1-19-01; 8:45 am]
BILLING CODE 4910-60-P