[Federal Register Volume 67, Number 157 (Wednesday, August 14, 2002)]
[Rules and Regulations]
[Pages 53118-53144]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-20118]



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Part III





Department of Transportation





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Research and Special Programs Administration



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49 CFR Part 171 et. al.



Hazardous Materials: Revision to Standards for Infectious Substances; 
Final Rule

  Federal Register / Vol. 67, No. 157 / Wednesday, August 14, 2002 / 
Rules and Regulations  

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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

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

ACTION: Final rule.

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SUMMARY: RSPA is revising transportation requirements for infectious 
substances, including regulated medical waste, to: adopt defining 
criteria and packaging requirements consistent with international 
standards; revise the current broad exceptions for diagnostic specimens 
and biological products; and authorize bulk packaging options for 
regulated medical waste consistent with requirements in international 
standards and DOT exemptions. These revisions will assure an acceptable 
level of safety for the transportation of infectious substances, and 
facilitate domestic and international transportation.

DATES: Effective Date: This final rule is effective October 1, 2002.
    Voluntary Compliance Date: Voluntary compliance is authorized 30 
days following publication of this final rule.
    Incorporation by Reference Date: The incorporation by reference of 
publications listed in this final rule has been approved by the 
Director of the Federal Register as of October 1, 2002.

FOR FURTHER INFORMATION CONTACT: Susan Gorsky (202) 366-8553, Office of 
Hazardous Materials Standards, Research and Special Programs 
Administration.

SUPPLEMENTARY INFORMATION:

List of Topics

I. Background
II. Comment Summary
    A. Pending Revisions to the UN Recommendations
    B. Infectious Substance Definition
    C. Packaging Requirements for Infectious Substances
    D. Exceptions for Domestic Shipments of Infectious Substances
    E. Diagnostic Specimens
    F. Biological Products
    G. Genetically Modified Micro-Organisms
    H. Regulated Medical Waste
    I. Used Health-Care Products
    J. Hazard Communication
    K. Training
    L. Contaminated Food and Food Products
III. Section-by-Section Review
IV. Coordination with Other Federal Agencies
V. Security Issues
VI. Regulatory Analyses and Notices
    A. Executive Order 12866 and DOT Regulatory Policies and 
Procedures
    B. Executive Order 13132
    C. Executive Order 13175
    D. Regulatory Flexibility Act
    E. Paperwork Reduction Act
    F. Regulation Identifier Number (RIN)
    G. Unfunded Mandates Reform Act
    H. Environmental Assessment

I. Background

    On January 22, 2001, the Research and Special Programs 
Administration (RSPA, we) published a notice of proposed rulemaking 
(NPRM; 66 FR 6941) to revise the current requirements in the Hazardous 
Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to the 
transportation of infectious substances, including regulated medical 
waste. The NPRM also proposed new requirements applicable to the 
transportation of genetically modified micro-organisms. The NPRM 
proposed the following changes to the HMR:
     Adoption of new classification criteria for infectious 
substances based on defining criteria developed by the World Health 
Organization (WHO) and consistent with standards contained in 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).
     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. We proposed 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 Food and Drug Administration 
(FDA) or U.S. Department of Agriculture (USDA) regulations.
     New transportation requirements for the transportation of 
genetically modified micro-organisms consistent with the UN 
Recommendations.
     New bulk packaging options for the transportation of 
regulated medical waste (RMW), based on current exemption provisions.
     New hazard communication requirements for shipments of 
Division 6.2 materials.

II. Comment Summary

    We received 46 comments on the NPRM from industry associations, 
laboratories, medical waste transporters, state departments of 
transportation and public health, a blood bank, and private citizens. 
Most were supportive of our effort to harmonize the HMR requirements 
applicable to the transportation of infectious substances with 
international requirements, and of proposals to enhance the safe 
transportation of diagnostic specimens and biological products. Based 
on comments received and our discussions with other Federal agencies 
responsible for regulating infectious substances and genetically 
modified micro-organisms, this final rule incorporates the following 
changes to the HMR:
     New classification criteria for infectious substances 
based on defining criteria developed by WHO and consistent with 
standards contained in the UN Recommendations and the ICAO Technical 
Instructions.
     Revised packaging requirements for Division 6.2 materials 
consistent with international performance standards.
     Revised materials of trade exceptions to include certain 
diagnostic specimens, biological products, and RMW. This final rule 
includes more specific packaging requirements for such materials of 
trade than were proposed in the NPRM.
     New packaging and hazard communication requirements for 
shipments of diagnostic specimens consistent with international 
requirements. Diagnostic specimens transported in dedicated motor 
vehicles by private or contract carriers are excepted from most 
requirements of the HMR. This final rule also clarifies that diagnostic 
specimens that contain a Risk Group 1 pathogen, do not contain a 
pathogen, or in which the pathogen is neutralized or inactive, are not 
subject to HMR requirements.
     Modification of the current exception from requirements in 
the HMR for biological products. This final rule revises the proposal 
in the NPRM to specify that the exception is limited to biological 
products, including experimental products, subject to Federal approval, 
permit, or licensing requirements, such as those required by FDA or 
USDA.

[[Page 53119]]

     New bulk packaging options for the transportation of RMW, 
based on current exemption provisions. The packaging options proposed 
in the NPRM are modified in this final rule to reflect commenters' 
concerns about specifications for the packagings.
     New hazard communication requirements for bulk shipments 
of RMW to assist emergency responders to identify such shipments.
    In discussions during development of this final rule, several 
federal agencies involved in the regulation of genetically modified 
organisms (i.e., the Environmental Protection Agency (EPA) and the 
Department of Agriculture (USDA)) commented that the process of 
genetically modifying an organism does not a priori make that organism 
a hazard. Rather, the product of the modification must be evaluated for 
potential risk. As several federal agencies currently regulate 
genetically modified organisms, the proposals in the NPRM concerning 
genetically modified organisms are not adopted in this final rule.
    Comments we received in response to the NPRM are discussed in 
detail below.

A. Pending Revisions to the UN Recommendations

    Most commenters support our proposal to harmonize the HMR 
requirements for infectious substances with the international 
standards. Two commenters note the United Nations may be developing a 
complete revision to its current recommendations for the transportation 
of infectious substances. According to these commenters, the UN may 
change the WHO risk group system as applied to transportation and may 
``radically'' simplify current transportation requirements. These 
commenters advise us to postpone revising the HMR until the United 
Nations completes its work.
    The commenters are correct. The UN Committee of Experts on the 
Transport of Dangerous Goods is considering revisions to the 
requirements in the UN Recommendations applicable to the transport of 
infectious substances and genetically modified micro-organisms. 
However, it is not certain whether any amendment will be adopted during 
the 2001-2002 biennium. Indeed, as yet the UN Committee of Experts has 
not received a formal proposal. Given this uncertainty, we do not agree 
with delaying action to harmonize the HMR requirements for infectious 
substances with current international standards. If the UN Committee of 
Experts adopts revisions to the UN Recommendations for transporting 
infectious substances, we will consider such revisions in a future 
rulemaking.
    One commenter notes the proposal as it relates to diagnostic 
specimens is not consistent with current requirements for transporting 
diagnostic specimens in the ICAO Technical Instructions. This is true; 
as we noted in the January 2001 NPRM, the proposal for shipping 
diagnostic specimens is consistent with a proposal for the UN 
Recommendations, since adopted. Since publication of the NPRM, the ICAO 
Dangerous Goods Panel has also adopted these amendments. As a result, 
the 2003-2004 edition of the ICAO Technical Instructions will be 
consistent with the UN Recommendations and this final rule.

B. Infectious Substance Definition

    In the NPRM, consistent with current requirements in the UN 
Recommendations, we proposed to define infectious substances, or 
Division 6.2 materials, to mean materials known to contain or suspected 
to contain a pathogen with the potential to cause disease upon 
exposure. We further proposed to require Division 6.2 materials to be 
assigned to risk groups using defining criteria developed by WHO. WHO 
defines four risk groups for infectious substances based on 
pathogenicity, mode and ease of transmission, degree of risk to 
individuals and communities, and reversibility of the disease through 
known and effective preventative agents and treatment. Risk Group 1 
includes micro-organisms unlikely to cause human or animal disease. In 
the NPRM, we proposed that Risk Group 1 materials not be subject to 
regulation under the HMR.
    Several commenters oppose using the WHO risk group criteria for 
infectious substances regulated under the HMR. They note that the WHO 
system was intended for assessing and addressing risks to researchers 
and health care workers in laboratory environments, not for 
transportation. We do not agree. While it is true the WHO risk groups 
were not originally intended for transportation environments, they do 
provide a relatively simple way to delineate and differentiate risks 
associated with specific pathogens. As such, the WHO risk groups are a 
useful tool for assessing the degree to which specific pathogens should 
be regulated in transportation, based on the potential risk to 
transportation workers and the general public. Other risk systems (for 
example, the biosafety level guidelines in the Centers for Disease 
Control and Prevention/National Institutes of Health (CDC/NIH) 
publication Biosafety in Microbiological and Biomedical Laboratories) 
were also developed for use in laboratories rather than in 
transportation. These systems can be more difficult to apply for 
transportation purposes than the WHO risk groups.
    Some commenters opposed to the use of the WHO risk groups recommend 
we create an advisory group to assign risk group classifications for 
infectious substances in transportation. We do not believe this is a 
practical or feasible approach because of the length of time that would 
be involved in establishing the advisory group and awaiting the results 
of its deliberations. Other commenters opposed to use of the WHO risk 
groups suggest we adopt government or industry consensus standards for 
risk group assignments, such as those developed by NIH. The NIH and WHO 
lists are very similar; NIH has published specific names of micro-
organisms assigned to each risk group in a table. Although not 
complete, the NIH list is a useful reference source for identifying the 
appropriate risk group for a given pathogen. (The NIH guidelines can be 
found at http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html). 
There are other risk group listings that also provide useful guidance 
for assigning a specific pathogen to a risk group, including a list 
developed by the American Biological Safety Association (available on 
line at http://www.absa.org/riskgroups/index.htm) and the list of 
agents in the CDC/NIH publication Biosafety in Microbiological and 
Biomedical Laboratories (available on line at http://www.cdc.gov/od/ohs/biosfty/biosfty.htm). We do not agree the HMR should incorporate 
one or more of these lists by reference into the HMR. However, in this 
final rule we are including these lists in the table of informational 
materials in Sec. 171.7(b).
    Instead of the WHO risk groups, one commenter suggests we utilize 
the existing Packing Group system in the HMR to address differing risks 
associated with the transportation of specific infectious substances. 
Thus, the commenter suggests Packing Group I would contain virulent 
pathogens that have a high risk of airborne infection, readily 
penetrate unbroken skin, are extremely persistent in the environment, 
and for which effective preventative or treatment measures are not 
readily available. Packing Group II would contain pathogens with a 
significantly lower risk of airborne infection, the primary exposure 
risk of which is entry through broken skin or contact with mucous 
membranes, and for which effective preventative or

[[Page 53120]]

treatment measures are readily available. Packing Group III would 
contain pathogens classed as WHO Risk Group 2 materials.
    We do not agree the existing Packing Group system provides a viable 
alternative to the WHO risk groups. As set forth in the NPRM, the WHO 
risk groups are used to identify pathogens not subject to regulation 
(Risk Group 1) or to identify certain pathogens (Risk Group 2 and 3) 
that may be shipped under certain exceptions, such as materials of 
trade. Unless an exception is authorized, all Risk Group 2, 3, and 4 
infectious substances must be transported in specification triple 
packagings authorized under the HMR. In addition, they must be marked 
and labeled in accordance with applicable requirements, and accompanied 
by appropriate shipping and emergency response documentation. The 
packing group system suggested by the commenter would require shippers 
to distinguish between Risk Group 2 and 3 infectious substances when 
making packaging decisions, and would be more difficult, confusing, and 
burdensome to implement than the system proposed in the NPRM.
    The NPRM proposed to assign infectious substances to risk groups 
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. One commenter suggests this provision could endanger patient 
confidentiality and violate medical privacy regulations. We disagree. 
The proposal does not require health care professionals to disclose 
medical histories or patient symptoms. Rather, the proposal suggests 
these factors should be considered as the health care professional 
assigns an infectious substance to a risk group for purposes of 
transportation. Disclosure of the factors contributing to this 
determination or the name of the patient is not required. Further, the 
requirement for inclusion of an itemized list of contents within a 
package containing Division 6.2 materials requires a shipper only to 
identify the material. There is no requirement to include a patient 
name on the itemized list.
    One commenter suggests we modify the list of factors used to 
determine risk group assignments to include the type of test ordered on 
the specimen. We do not believe it is necessary to specify this 
information as a factor in making risk group determinations. Shippers 
should make risk group assignments based, in part, on professional 
judgement concerning the individual circumstances of the patient or 
animal. Such professional judgement should include the types of tests 
ordered or other factors.
    One commenter recommends we regulate infectious substances meeting 
the defining criteria for a Risk Group 1 material for transportation 
purposes We disagree. By definition, Risk Group 1 infectious substances 
are micro-organisms unlikely to cause human or animal disease. Risk 
Group 1 infectious substances in transportation pose little or no risk 
to transportation workers or to the general public. Risk Group 1 
infectious substances are not subject to regulation under international 
transportation requirements because the risk posed by such materials is 
very low. There is no compelling safety rationale for regulating such 
materials under the HMR.
    A number of commenters suggest specific revisions to the proposed 
definition of infectious substances. For example, several recommend 
including prions in the definition. Prions are not micro-organisms, but 
are proteinaceous infectious particles consisting of an abnormal 
isoform of a normal cellular protein. Prions are implicated as a cause 
for neuro-degenerative diseases such as kuru and Creutzfeldt-Jacob 
disease in humans, and bovine spongiform encephalopathy and scrapie in 
animals. We agree with commenters that a strict reading of the proposed 
definition in the NPRM would appear to exclude prions; therefore, we 
have modified the definition to specifically include them. We further 
revised the definition for clarity and to remove superfluous or 
inaccurate terminology.
    One commenter suggests limiting regulation of infectious substances 
in transportation to those capable of infecting ``immunocompetent 
humans and animals.'' For purposes of the HMR, ``immunocompetent'' 
would mean the human or animal possesses an effective body immune 
mechanism with no reduced immunity to infection by any known cause. We 
disagree. The WHO risk group system assigns infectious substances to 
risk groups based on their ability to infect immunocompetent humans and 
animals. Thus, it is not necessary to make this explicit in the HMR.
    Accordingly, in this final rule we are defining Division 6.2 
materials using the WHO risk group criteria. Division 6.2 materials 
must 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. Assignments to risk 
groups are 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 are 
excepted from all HMR requirements, unless they meet the definition of 
another hazard class.

C. Packaging Requirements for Infectious Substances

    In the NPRM, we proposed to incorporate several changes to the 
infectious substances regulations applicable to packaging requirements 
and performance tests. The changes were intended to make the HMR 
requirements consistent with the UN Recommendations and ICAO Technical 
Instructions For example, we proposed to require manufacturers to meet 
UN marking requirements for packagings represented as conforming to the 
specifications for infectious substances packagings in the HMR. In 
addition, we proposed to require manufacturers to retain packaging 
design qualification records and to retest packagings every 24 months. 
Further, we proposed to replace the current requirement for a water 
immersion test with a water-spray test to simulate exposure to 
rainfall, as required by the ICAO Technical Instructions. Similarly, we 
proposed 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 package, if an equivalent 
level of performance is maintained. Commenters endorse these proposals. 
We are adopting them in this final rule without change.
    One commenter suggests a more stringent packaging requirement for 
infectious substances. The commenter recommends we replace the current 
triple packaging requirement (water-tight primary receptacle, water-
tight secondary packaging, and outer packaging) with a quintuple 
packaging. In the quintuple packaging, the primary receptacle is 
enclosed in a sealed plastic bag with absorbent material inside a 
watertight primary container inside a watertight secondary container 
inside a tertiary container or overpack. We disagree. The accident 
record demonstrates a triple packaging meeting the performance standard 
established in the HMR is sufficient to contain the material under 
normal conditions of transportation.

[[Page 53121]]

D. Exceptions for Domestic Shipments of Infectious Substances

    In the NPRM, we proposed to expand the materials of trade (MOTS) 
exceptions currently permitted under Sec. 173.6 of the HMR. The 
proposal expanded the MOTS exception to include certain biological 
products, diagnostic specimens, and RMW, including cultures and stocks. 
MOTS 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 
MOTS exception limits the maximum gross weight of MOTS that may be 
carried on a motor vehicle and includes minimum packaging and hazard 
communication requirements. As proposed in the NPRM, the MOTS exception 
for infectious substances specified combination packagings, with 
limitations on capacity.
    A number of commenters address the proposed MOTS exception for 
infectious substances. Several commenters oppose the exception, 
suggesting it is too broad and does not provide adequate packaging or 
hazard communication. Other commenters support the exception, but 
recommend we incorporate minimal acceptable standards for packaging. 
These commenters note that most items shipped under the MOTS exception 
must be shipped in their original packaging or the equivalent. However, 
biological products, diagnostic specimens, and RMW are packaged for the 
first time when they are collected at the site from which they will be 
shipped. Thus, these commenters suggest the inner packaging should be 
puncture- and leak-resistant and there should be sufficient absorbent 
material for the contents of the inner packaging.
    We agree with commenters that the MOTS exception for Division 6.2 
materials should include general packaging standards. Therefore, in 
this final rule, we are adding performance requirements for combination 
packagings authorized under the MOTS exception for transportation of 
Division 6.2 materials. The inner packaging of the combination 
packaging must be leak tight for liquids, and the outer packaging must 
contain absorbent material sufficient to absorb the entire contents of 
the inner packagings. For sharps, which are objects that can pierce 
certain types of packaging, the inner packaging of the combination 
packaging must be constructed of a rigid, puncture-resistant material. 
For all Division 6.2 materials, the outer packaging must be a strong, 
tight packaging that is securely sealed. Note that Division 6.2 
materials shipped in conformance with the MOTS exception are subject to 
all applicable requirements in Sec. 173.6. This includes requirements 
to mark packages with a common name or proper shipping name, and to 
inform the motor vehicle operator of the presence of a hazardous 
material and the requirements of Sec. 173.6.
    A commenter asks us to clarify the MOTS exception for RMW, with 
respect to home health care providers. Specifically, this commenter 
believes the NPRM was confusing in its treatment of waste generated 
from households. The commenter states the NPRM proposed the MOTS 
exception in Sec. 173.6 as appropriate for home health care providers. 
At the same time, the NPRM provided a complete exception in 
Sec. 173.134 from HMR requirements for medical waste generated from 
households and transported in accordance with applicable state or local 
requirements. The exception for medical waste generated from households 
applies to waste collected by local sanitation workers along with 
trash, garbage, and other non-medical household waste. The MOTS 
exception applies to RMW generated through home treatment of medical 
conditions by professional health care providers. These health care 
providers remove such waste and transport it elsewhere for disposal.
    One commenter recommends the HMR include an exception from all 
transportation regulatory requirements, except for minimal packaging 
standards, for Risk Group 2 materials transported by highway. The 
commenter did not provide a reason for this recommendation. We 
disagree. Risk Group 2 infectious substances can pose risks to 
transportation workers and the general public. We believe they should 
be regulated in the same manner as Risk Group 3 infectious substances.
    One commenter suggests the final rule should include an exception 
for environmental microbiological samples collected in the field to 
evaluate occupational and residential exposure risks. An example is a 
piece of moldy wallboard. The organisms in such samples are 
predominantly from the environment rather than humans, and therefore 
pose a limited risk of infection to the individual or the community. We 
agree and so modified the list of materials excepted from the HMR to 
include environmental microbiological samples being transported for 
analysis and/or testing. Note, however, that a material or object known 
or suspected to be contaminated with an infectious substance must be 
transported in accordance with all applicable HMR requirements.
    The same commenter also expresses a concern about the effect of the 
proposals in the NPRM on samples shipped to laboratories to evaluate 
their proficiency in analyzing and identifying pathogens and other 
materials. The commenter is concerned the NPRM would require such 
samples to be identified in shipping documentation or on labels. In 
fact, this is not the case. The HMR requires the technical name of an 
infectious substances to be shown in parentheses as part of the basic 
shipping description on shipping papers and package markings. However, 
the definition of ``technical name'' in Sec. 171.8 of the HMR permits 
use of a generic description in place of the technical name for 
proficiency testing. Thus, an infectious substance sample sent to a 
laboratory for proficiency testing may show a generic microbiological 
description, such as bacteria, myobacteria, fungus, or viral sample, as 
part of the shipping description. Packaging, marking, and labeling the 
proficiency testing sample as an infectious substance and using a 
generic technical name should not compromise proficiency testing 
programs.

E. Diagnostic Specimens

    In the NPRM, we proposed regulations applicable to the 
transportation of diagnostic specimens consistent with the UN 
Recommendations. Diagnostic specimens are human or animal material 
being transported for diagnostic or investigational purposes. We 
proposed a new entry in the Hazardous Materials Table--``Diagnostic 
Specimen.'' We did not propose a UN number, warning label, or packing 
group assignment.
    As proposed in the NPRM, diagnostic specimens meeting the 
definition of a Risk Group 4 material would be classed and required to 
be transported as Division 6.2 materials, UN 2814 or UN 2900. All other 
diagnostic specimens would be packaged in non-specification packagings 
meeting minimum performance criteria. Under the proposal, packages 
containing diagnostic specimens would be required to be marked 
``Diagnostic Specimens.'' Diagnostic specimens shipped in accordance 
with these provisions would be excepted from all other HMR 
requirements, except for incident reporting for diagnostic specimens 
transported by aircraft.

[[Page 53122]]

    Several commenters oppose the NPRM proposal for diagnostic 
specimens. These commenters suggest that requirements for the shipment 
of diagnostic specimens should be applied based on whether a specimen 
could reasonably be suspected of being infectious. According to these 
commenters, any shipments other than routine screening samples or 
samples transported to investigate non-communicable diseases or 
conditions should be fully regulated as Division 6.2 materials. As we 
noted in the NPRM (66 FR 6944), we issued an ANPRM under this docket 
(63 FR 46844; September 2, 1998) proposing a regulatory regime for 
diagnostic specimens similar to this commenter's suggestion. Commenters 
to the ANPRM almost unanimously opposed this approach, stating it would 
be difficult and costly to implement. Commenters to the ANPRM also 
stated such a requirement could result in shipment delays. This would 
make early detection and treatment of disease difficult, and could 
significantly increase health care costs. We agreed. The NPRM proposal 
specifies a more practical, cost-effective, and easy-to-understand 
regulatory system for diagnostic specimens, consistent with 
requirements established in the UN Recommendations.
    A number of commenters suggest the table entry for diagnostic 
specimens is ambiguous and may cause confusion. The table entry 
indicates that diagnostic specimens are regulated as hazardous 
materials. However, the specific provisions proposed for transportation 
of diagnostic specimens except such shipments from most requirements 
applicable to hazardous materials. Several commenters recommend we 
remove the entry from the table, to clarify that diagnostic specimens 
are not regulated as hazardous materials.
    We disagree. In fact, the NPRM proposed a table entry for 
diagnostic specimens precisely to indicate diagnostic specimens would 
be regulated as hazardous materials under the HMR. There are a number 
of materials listed in the table as hazardous materials that are 
excepted from most HMR requirements, as we proposed to do for 
diagnostic specimens. For example, lithium batteries are regulated for 
transportation purposes as a hazardous material and are listed in the 
table, but are excepted from many requirements of the HMR when shipped 
in accordance with the provisions in Sec. 173.185.
    One commenter notes that diagnostic specimens are usually shipped 
with a transport media. The transport media preserves the specimen, 
prevents overgrowth, and facilitates isolation and analysis. This 
transport media may inactivate or disable any pathogens contained in 
the specimen. The commenter states that the NPRM overlooks this aspect 
of diagnostic specimens shipments, exaggerating the risk associated 
with transportation. Other commenters agree and suggest the final rule 
should clarify that if no pathogen is present in the diagnostic 
specimen or if the pathogen is neutralized, then the specimen is not 
regulated under the HMR. We agree. In this final rule, we added 
diagnostic specimens in which no pathogen is present or the pathogen is 
neutralized to the list of materials not subject to regulation as 
infectious substances under the HMR. Note, however, that a transport 
media used in the shipment of infectious substances may itself be a 
hazardous material--i.e., it meets the definition of one of the defined 
hazard classes based on flammability, corrosivity, toxicity, or other 
hazard characteristic. If so, the shipment must be transported in 
accordance with HMR requirements for the specific hazard class. Note, 
also, that a diagnostic specimen shipped in a packaging with a 
neutralizing agent designed to function only if the inside packaging 
containing the diagnostic specimen ruptures or breaks, must be shipped 
in accordance with the requirements applicable to diagnostic specimens 
in Sec. 173.199.
    Several commenters suggest the regulations should take into account 
the physical nature of a diagnostic specimen when prescribing packaging 
requirements. For example, commenters state certain diagnostic samples, 
such as dried blood spots, fecal smears, and skin punches, do not 
present the same risks in transportation as liquid or semi-solid 
diagnostic samples. Similarly, commenters state urine and oral tissues 
are incapable of transmitting disease in the same manner as blood. 
These commenters recommend modification of the regulations to 
distinguish between diagnostic specimens that pose a threat of 
infection to transport workers and the general public, and those that 
do not. We disagree. Solid-form diagnostic specimens potentially 
containing infectious substances do present a risk of infection, as do 
urine and oral tissues. Although this risk may be less than for blood, 
we believe the minimal packaging standards for the transportation of 
diagnostic specimens should apply consistently to all materials meeting 
the definition of a diagnostic specimen in this final rule. Moreover, 
the packaging standards established in this final rule do distinguish 
between solid- and liquid-form diagnostic specimens. For example, the 
capacity limits for liquid diagnostic specimens are less. Further, 
liquid diagnostic specimen packagings transported by aircraft must be 
capable of withstanding, without leakage, an internal pressure 
producing a pressure differential of not less than 95 kPa.
    Several commenters address the specific packaging requirements 
proposed for the transportation of diagnostic specimens. The NPRM 
proposed to require diagnostic specimens to be packaged in primary 
receptacles packed inside secondary packaging, secured in an outer 
packaging with suitable cushioning material. One commenter states there 
is no need to secure the secondary packaging inside the outer 
packaging, because the specimen is twice contained in leak-proof, 
watertight packaging with absorbent material in between. This commenter 
asserts the proposal adds to overall packaging costs with no 
transportation safety benefit. We disagree. The requirement to secure 
secondary packaging inside the outer packaging helps assure the 
integrity of the entire packaging, by preventing damage to the 
secondary packaging resulting from handling during transportation. 
Moreover, the requirement is consistent with international standards. 
Further, secondary packaging can be secured inside an outer packaging 
in several ways that do not necessarily involve tying or fastening the 
secondary packaging to the outer packaging. For example, if the 
secondary packaging fits snugly within the outer packaging, the 
secondary packaging would be considered to be secured within the outer 
packaging.
    In addition, several commenters state the proposed capacity limits 
on packages of diagnostic specimens should be more flexible to 
accommodate dry ice for preservation of specimens. The NPRM proposed an 
outer packaging capacity limit of 4L (1 gallon) for liquid diagnostic 
specimens, and 4 kg (8.8 pounds) for solid diagnostic specimens. These 
capacity limits apply to the diagnostic specimen only; packagings may 
be larger to accommodate dry ice used for preservation of specimens. 
Note, however, that shipments using dry ice are subject to applicable 
requirements in Sec. 173.217.
    Another commenter suggests the packaging requirements for 
diagnostic specimens should be more stringent than in the NPRM. This 
commenter recommends a quintuple packaging, consisting of a primary 
receptacle

[[Page 53123]]

enclosed in a sealed plastic bag contained in a primary container, 
inside a secondary container, inside a tertiary container. We disagree. 
The packaging for diagnostic specimens proposed in the NPRM is 
consistent with packaging requirements in the UN Recommendations. 
Further, the packaging suggested by the commenter would add 
significantly to the cost of shipping diagnostic specimens.
    One commenter addresses the ``diagnostic specimen'' marking 
requirement proposed in the NPRM. This commenter states the proposed 
marking requirement is redundant and provides no transportation 
benefit. We disagree. Under the proposal in the NPRM, packages 
containing diagnostic specimens must be marked ``Diagnostic Specimen.'' 
No other marking or labeling is required, nor are shipping papers 
required; thus, it is difficult to see how the proposed marking could 
be ``redundant.'' The marking is intended to communicate a potential 
hazard to transportation workers. Diagnostic specimens shipped in 
accordance with the provisions in the NPRM could contain infectious 
material, and the marking indicates transportation workers should take 
appropriate precautions if the package is damaged or leaking.
    Another commenter suggests we adopt and modify the ``Excepted 
Quantities Label'' authorized by International Air Transport 
Association (IATA) standards, to indicate a shipment contains a 
diagnostic specimen. We believe the marking requirement in this final 
rule accomplishes the same goal without the additional regulatory 
burden that would result from a new labeling requirement. However, this 
final rule does not prohibit shippers from voluntarily applying the 
``Excepted Quantities Label'' to such packages in addition to the 
``Diagnostic Specimen'' marking.
    In addition to the MOTS exception previously discussed, the NPRM 
also proposed a complete exception from the HMR for diagnostic 
specimens transported by private or contract motor carriers. One 
commenter opposes this exception, out of concern that inadequate 
packaging would expose untrained emergency response personnel to 
potentially infectious materials. However, most commenters generally 
are supportive of this proposal, agreeing the packaging and procedures 
used for courier shipments of diagnostic specimens are sufficient to 
assure the safety of such shipments in transportation. Further, 
couriers are familiar with the materials they transport, and are 
trained in the application of the Occupational Safety and Health 
Administration (OSHA) standards for Universal Precautions for handling 
materials potentially containing infectious substances. Therefore, this 
exception is adopted as proposed in this final rule.
    The NPRM proposed to except diagnostic specimens prepared in 
accordance with proposed Sec. 173.199 from training requirements in 
Subpart H of Part 172 of the HMR. In lieu of training, the NPRM 
proposed to require offerors and transporters of diagnostic specimens 
to be informed of the diagnostic specimen packaging requirements. 
Commenters did not specifically address this aspect of the proposed 
requirements for diagnostic specimens in the NPRM. One commenter asked 
us to clarify the meaning of ``must be informed'' as used in proposed 
Sec. 173.199.
    As used in new Sec. 173.199 of this final rule, ``must be 
informed'' means persons who offer or transport diagnostic specimens 
for transportation in accordance with Sec. 173.199 must know about and 
be able to apply the requirements of Sec. 173.199 to specific 
shipments. There are no record-keeping or certification requirements 
associated with this provision, which distinguishes this requirement as 
a less formal type of training requirement than would otherwise be 
required by subpart H of part 172. In this final rule, we modified the 
NPRM proposal to indicate persons who ship or transport diagnostic 
specimens must know about the provisions in Sec. 173.199.
    The NPRM proposed to subject diagnostic specimens transported by 
aircraft to incident reporting requirements. Several commenters oppose 
this proposal. They suggest an incident-reporting requirement may cause 
air carriers to refuse shipments of diagnostic specimens, which could 
lead to serious delays in the testing process and adversely affect the 
provision of quality health care to patients. We disagree that the 
incident reporting requirement should be removed from this final rule. 
Commenters' suggestion that air carriers may refuse shipments as a 
result of this requirement is speculative; no air carriers indicated 
they would refuse shipments as a result of this provision. Further, we 
believe the benefits of incident reporting will be significant. Since 
diagnostic specimens are currently excepted from all regulatory 
requirements in the HMR, we currently have only anecdotal information 
concerning incidents involving diagnostic specimens. Information 
provided through incident reports will allow us to more fully evaluate 
the risks posed by these materials in transportation and to assess the 
efficacy of the packaging requirements imposed by this final rule.
    One commenter suggests air carriers may not be able to identify a 
leak as coming from a package containing a diagnostic specimen. Since 
the package must be marked with the words ``Diagnostic Specimen,'' we 
do not believe such identification will be difficult.
    Two commenters suggest the proposed requirements for transporting 
diagnostic specimens will be ``prohibitively expensive'' for the 
industry. However, these commenters do not provide supporting evidence 
for this assertion. We disagree. The provisions for air shipment of 
diagnostic specimens are consistent with the UN Recommendations and 
will be consistent with the 2003-2004 Edition of the ICAO Technical 
Instructions, which most air carriers follow for both domestic and 
international transportation. Further, the final rule includes several 
exceptions for ground transportation of diagnostic specimens, thus 
minimizing new costs for health care providers.
    Accordingly, this final rule adopts the provisions applicable to 
the transportation of diagnostic specimens proposed in the NPRM. 
Diagnostic specimens meeting the definition of a Risk Group 4 material 
must be classed and transported as Division 6.2 materials, UN 2814 or 
UN 2900. Diagnostic specimens known or suspected to contain a Risk 
Group 2 or 3 infectious substance must be packaged in primary 
receptacles packed inside secondary packaging to preclude breakage, 
punctures, or leakage. For liquids, there must be sufficient absorbent 
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 
Specimen.'' Diagnostic specimens shipped in conformance with these 
provisions are excepted from all other requirements in the HMR, with 
one exception. Diagnostic specimens transported on board aircraft are 
subject to the incident reporting requirements in Secs. 171.15 and 
171.16. Under this

[[Page 53124]]

final rule, offerors and transporters of diagnostic specimens must know 
about the diagnostic specimen packaging requirements. A commenter asked 
if diagnostic specimens shipped in conformance with these provisions 
would be subject to HMR requirements for notification-of-pilot-in-
command. The answer is no.
    We note that waste diagnostic specimens--diagnostic specimens 
meeting the definition for RMW in this final rule--may not be 
transported under the exceptions established in this final rule for the 
transportation of diagnostic specimens. Waste diagnostic specimens lose 
their identity as diagnostic specimens for purposes of the HMR, and 
must be transported in accordance with the HMR requirements applicable 
to RMW.

F. Biological Products

    Commenters to the NPRM generally support its proposals concerning 
transportation of biological products. Currently, biological products 
are excepted from the HMR provided they meet FDA or USDA regulations 
governing the transfer of biological products. In the January 2001 
NPRM, we proposed to limit this exception to biological products 
meeting the definition of a Risk Group 1 material or licensed for use 
under current FDA or USDA regulations. We proposed to require 
unlicenced 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 proposed to add a special provision in Sec. 172.102 
relating to the transportation of blood and blood products. For 
consistency with ICAO Technical Instruction Special Provision A81, this 
special provision would except blood and blood products from current 
quantity limits for shipments by air when the materials are packaged in 
primary receptacles not exceeding 500 mL (17 ounces) and contained in 
outer packagings not exceeding 4 L (1 gallon).
    We also proposed to except from all HMR requirements the following: 
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.
    A number of commenters note that veterinary biological products are 
regulated by USDA, regardless of their licensing status. Such 
veterinary biological products are subject to comprehensive regulation 
(9 CFR Parts 101 through 124). For example, veterinary biological 
products in pre-license status are regulated by USDA under 9 CFR 103.3 
and are shipped only after USDA review and approval. The USDA 
requirements are designed to assure that the biological materials are 
not contaminated during shipment and pose no threat to agriculture or 
livestock. Similarly, under the Virus-Serum-Toxic Act of 1913 (21 
U.S.C. 151 et seq.), imported veterinary biological products are 
subject to permit rather than licensing requirements. USDA regulations 
assure that imported veterinary biological products meet the same high 
standards for distribution and sale in the United States as 
domestically produced biological products. Based on USDA's 
comprehensive regulatory scheme, commenters recommend that imported 
veterinary biological products subject to USDA permitting procedures be 
excepted from HMR requirements. We agree biological products subject to 
USDA regulation should be excepted from HMR requirements, and have 
modified the list of exceptions in this final rule accordingly.
    A commenter recommends we expand the exception from regulation for 
biological products subject to Federal approval and licensing 
requirements, to include products manufactured by facilities licensed 
by or registered with a Federal agency. We disagree. The current 
exception is product-specific because Federal requirements for approval 
and licensing of biological products assure their safety. Products 
manufactured by licensed or registered facilities may or may not be 
subject to Federal approval processes and so may or may not have a 
record demonstrating their safety.
    One commenter disagrees with the proposed exception in the NPRM for 
blood collected for transfusions. The commenter states all human blood 
should be treated as infectious material. If not, transport workers 
would be subject to less stringent protective requirements than 
laboratory and hospital workers. We disagree. Blood collection 
facilities are subject to the OSHA regulations for handling potentially 
infectious blood and blood products (29 1910.1030). The OSHA 
regulations include requirements for handling, packaging, and shipping 
blood. Because blood collection facilities are subject to OSHA 
regulations, we believe an exception from the HMR for blood collected 
for transfusion is justified.
    One commenter suggests the exception for blood collected for 
transfusion and blood products should be expanded to include blood and 
plasma transported for testing as part of the donor process. We agree 
that blood sent for testing as part of the donor process should be 
excepted from regulation under the HMR. Therefore, we modified the 
proposal in the NPRM to except from the HMR blood sent for testing as 
part of the donor process, unless the person collecting the blood has 
reason to believe the sample contains an infectious substance. In such 
instances, the blood sent for testing must be packaged and shipped as a 
diagnostic specimen. Note also that blood and blood products 
transported for testing as part of the donor process is subject to OSHA 
requirements for handling and shipping.
    Several commenters suggest the proposed exception from HMR 
requirements for blood collected for transfusion and blood products, 
organs, and tissues intended for transplant, should be expanded to 
include plasma derivatives. Plasma derivatives are derived from the 
same units of pre-screened blood used for transfusion. However, plasma 
derivatives are not ``transfused.'' They are ``infused.'' These 
commenters request clarifying the final rule to specify plasma 
derivatives are covered by the same exception as blood collected for 
transfusion. Plasma derivatives are covered under the exception for 
biological products in Sec. 173.34(b) of this final rule. Therefore, no 
additional clarifying language is necessary.
    A number of commenters note the proposed addition of Special 
Provision A81 does not reflect the most recent amendments to the UN 
Recommendations and the ICAO Technical Instructions. Effective June 20, 
2001, the UN Recommendations and ICAO Technical Instructions include a 
Special Provision to except from aircraft quantity limits, body fluids 
packed in primary receptacles not exceeding 1,000 mL in outer 
packagings not exceeding 4 L. In this final rule, we revised Special 
Provision A81 for consistency with the most recent editions of the UN 
Recommendations and ICAO Technical Instructions. Thus, under this final 
rule, Special Provision A81 applies to shipments of any body fluid 
(e.g., blood, plasma, urine, semen, saliva, spinal fluid, amniotic 
fluid, and the like).
    One commenter recommends we expand the exception from HMR 
requirements for blood collected for transfusions or blood products, to 
include waste generated from the collection and testing of blood and 
blood products. We disagree. Waste is not packaged and transported with 
the same care as blood and blood products intended for transfusion, 
even under the

[[Page 53125]]

exception granted in this final rule. Further, waste generated from the 
collection of blood may include sharps and similar objects.
    We note that all waste biological products--biological products 
meeting the definition for RMW in this final rule--may not be 
transported under the exceptions in this final rule 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.

G. Genetically Modified Micro-Organisms

    In the NPRM, we proposed adding ``Genetically modified micro-
organism'' to the Hazardous Materials Table as a Class 9 material. We 
proposed to require these materials to 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 also proposed two exceptions applicable to the 
transportation of genetically modified micro-organisms. First, we 
proposed 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 proposed 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.
    A number of commenters address the proposals for genetically 
modified micro-organisms. Of major concern to the commenters is that 
the proposed requirements are not risk-based, but instead assume 
genetically modified micro-organisms pose a threat during 
transportation merely because of the fact that they are genetically 
modified. One commenter asserts the proposed Class 9 definition for 
genetically modified micro-organisms is scientifically meaningless, 
burdensome, and likely to impede essential research and development 
involving these materials. Other commenters are concerned that, as 
defined in the NPRM, genetically modified micro-organisms could include 
products enhanced through biotechnology. They fear that the requirement 
to transport genetically modified micro-organisms as Class 9 materials 
could be interpreted to apply to bulk shipments of biotechnology-
enhanced agricultural commodities or products. Most commenters 
recommend we regulate genetically modified micro-organisms only when 
they also meet the definition of an infectious substance.
    We agree the NPRM proposals applicable to genetically modified 
micro-organisms may be unnecessarily broad, confusing, and difficult to 
apply and interpret. Further, there are a host of other stringent 
Federal requirements applicable to research, licensing, permitting, 
movement, and use of genetically modified micro-organisms. These 
regulatory systems were initially described in the policy statement 
referred to as ``The Coordinated Framework'' (51 FR 23302, June 26, 
1986). For more specific details, please see the appropriate agency 
websites--for example, the EPA Biopesticides and Pollution Prevention 
Division at http://www.epa.gov/pesticides/biopesticides/; the EPA 
Office of Pollution Prevention and Toxics at http://www.epa.gov/opptintr/biotech/index.html; the Animal and Plant Health Inspection 
Service at http://www.aphis.usda.gov; and the FDA Center for Food 
Safety and Applied Nutrition at http:// vm.cfsan.fda.gov/list.html.
    Because a number of Federal regulatory agencies have rigorous 
programs in place to regulate the safety and distribution of 
genetically modified micro-organisms, and because the United States is 
engaged in ongoing international negotiations concerning global 
regulation of these materials, the proposals in the NPRM applicable to 
genetically modified micro-organisms are not adopted in this final 
rule. Note, however, that genetically modified micro-organisms meeting 
the definition of a Division 6.2 material are subject to regulation 
under the HMR.

H. Regulated Medical Waste

    Commenters generally support the proposals in the NPRM to permit 
transportation of RMW in certain non-specification bulk packagings. 
However, commenters suggest several modifications to the proposals in 
the NPRM.
    The NPRM defines ``regulated medical waste'' to mean waste or 
reusable material containing or suspected of containing an infectious 
substance in Risk Groups 2 or 3. RMW 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. RMW containing an 
infectious substance in Risk Group 4 must be classed as Division 6.2, 
described as an infectious substance, and assigned to UN 2814 or UN 
2900, as appropriate. One commenter states the RMW definition is 
impossible to implement because generators of RMW will not know the 
specific materials contained in the waste. We disagree. Generators of 
RMW know the nature of the waste because of the materials they handle 
during the course of their operations. Further, Risk Group 4 materials 
are very closely regulated by the CDC, so a generator of RMW should 
know whether the waste contains a Risk Group 4 material.
    One commenter recommends we require RMW containing Risk Group 1 
infectious material to meet ``minor'' regulatory requirements. We 
disagree. As stated above, Risk Group 1 infectious substances are 
unlikely to cause human or animal disease, and so pose little or no 
risk to transportation workers or to the general public. There is no 
compelling safety rationale for regulating RMW containing only Risk 
Group 1 infectious material.
    The NPRM proposed to authorize certain non-specification bulk 
containers for use as outer packagings for the transportation of RMW. 
Two commenters oppose this proposal out of concern that it represents a 
relaxation of current requirements for authorized RMW packagings to 
meet Packing Group II performance standards. We disagree. This final 
rule retains the Packing Group II performance requirements for non-bulk 
packagings. For bulk packagings, which are currently authorized under 
the terms of 29 exemptions, this final rule permits RMW to be 
transported in certain non-specification packagings with proven safety 
records gained through exemptions experience. These packagings have a 
demonstrated safety record. In addition, this final rule establishes 
performance standards for the authorized bulk packagings, including a 
requirement for certain packagings to be capable of passing a drop test 
at the Packing Group II performance level.
    One commenter suggests the proposal would permit regulated medical 
waste to be transported in large, open-top, roll-off bulk containers. 
This is not the case. The non-specification bulk packagings authorized 
for the transportation of RMW must be closed with a lid or closure, to 
prevent intrusion of water into the packaging or release of contents 
from the packaging.
    Several commenters suggest the provisions applicable to authorized 
bulk packagings are needlessly detailed. For example, commenters 
question the necessity of the proposed requirement for a wheeled cart 
(Cart) to be mounted on a minimum of four wheels and to have a gasketed 
lid. We agree. In this

[[Page 53126]]

final rule, we modified the bulk packaging provisions to provide for 
more flexibility in their design.
    Other commenters suggest we should permit more flexibility for 
inner packagings inside bulk outer packagings. For example, one 
commenter notes that the 10-gallon limit on the size of sharps 
containers used as inner packagings, could preclude shipment of such 
items as specialized single-use drills, skin staple guns, and heart/
lung machine and cell saver canisters, as RMW. We agree and modified 
this final rule accordingly. For sharps containers, this final rule 
requires a container with a capacity greater than 20 gallons to be 
capable of passing the performance tests in Sec. 178.601 of the HMR at 
the Packing Group II performance level. A sharps container with a 
capacity of 20 gallons or less must be puncture resistant, but need not 
be capable of passing the Part 178 performance tests.
    Commenters do not address our proposal to allow RMW to be 
transported in ``Large Packagings,'' which are intermediate bulk 
packagings containing one or more inner packagings consistent with the 
requirements of the UN Recommendations. We adopted a definition for 
these packagings in a final rule issued under Docket HM-215D, published 
June 21, 2001 (66 FR 33316). The International Maritime Dangerous Goods 
Code also incorporates this definition. As defined 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 (7,000 liters, 793 
gallons, or 106 cubic feet) in volume. The proposals in the NPRM 
concerning Large Packagings are adopted without change in this final 
rule.
    One commenter raises concerns about the ``certification'' process 
for RMW packagings. The commenter suggests the ``certification'' 
standards are vague and assume manufacturing uniformity, which may or 
may not be present, according to the commenter. The commenter asserts 
``only the most sophisticated parties, that is, the larger 
transporters, have had containers certified'' and this limits 
generators' flexibility in selecting the most appropriate, cost-
effective packaging for transporting RMW. We disagree. Currently, the 
packaging standards in Sec. 173.197 specify that non-bulk packagings 
for RMW must conform to the requirements of Part 178 at the Packing 
Group II performance level. This means each packaging must be marked to 
certify the packaging conforms to all applicable requirements. The 
packaging design and manufacturing requirements apply to any 
manufacturer of a specification packaging, not just ``the most 
sophisticated parties.'' Further, bulk packagings for transportation of 
RMW are currently authorized only under the terms of exemptions. The 
proposals in the NPRM in fact increase flexibility, and thus reduce 
costs for offerors and transporters of RMW by providing a range of bulk 
packaging options. These options include non-specification packaging 
options, not currently authorized under the HMR. We are adopting the 
NPRM proposals in this final rule.
    The NPRM proposed to require inner packagings authorized for Large 
Packagings, Carts, and bulk outer packagings (BOP) to be marked or 
tagged with the name and location of the offeror. The proposal included 
an exception from these marking requirements when the entire contents 
of the Large Packaging, Cart, or BOP originate at a single facility and 
are delivered to a single location. One commenter opposes this 
exception. The commenter describes two incidents involving RMW found 
along public highways, presumably fallen from a transport vehicle. The 
bags within which the RMW was contained were not marked with the name 
and location of either the offeror or the consignee, and so could not 
be traced. The commenter suggests a lack of identification on inner 
packagings may exacerbate problems related to illegal dumping of RMW or 
poor package handling. We disagree. This exception is consistent with 
the current exception from marking for all hazardous materials 
shipments transported by highway without transfer from one motor 
carrier to another. This exception is also consistent with the current 
marking exception for shipments where the entire contents of a 
transport vehicle or freight container are shipped from one consignor 
to one consignee.
    In response to a petition for rulemaking, the NPRM proposed to 
revise the HMR to permit transportation of Risk Group 2 or 3 waste 
cultures or stocks in non-specification packagings when transported by 
common or contract carriers in dedicated vehicles. Commenters did not 
specifically address this proposal. It is adopted as proposed in this 
final rule.
    One commenter opposes the proposal in the NPRM to revise the 
quantity limitations applicable to shipments of RMW on aircraft. 
Currently, such shipments are forbidden. We proposed 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 proposed to 
continue to prohibit bulk shipments of RMW on board aircraft. The 
commenter suggests RMW shipments are not time critical, and thus do not 
need to be transported by air, except in the rare instances already 
authorized by Special Provision A14. (Special Provision A14 permits air 
shipments of small quantities of RMW when other means of transportation 
are impracticable or unavailable.) We disagree. The proposals for 
transporting RMW on board aircraft are adopted in this final rule for 
consistency with the UN Recommendations and ICAO Technical 
Instructions. When properly packaged, non-bulk shipments of RMW may be 
safely transported by air.
    One commenter notes many RMW generators depend on the entity 
transporting the RMW for many services related to the management of the 
waste. The commenter suggests the proposals applicable to RMW in the 
NPRM would require both generators and carriers to perform the same 
functions, greatly increasing the costs of compliance for generators. 
We disagree. A health care facility may contract with a waste hauler to 
perform all offeror functions associated with the transportation of its 
RMW. In this case, the waste hauler becomes the offeror of the RMW and 
is responsible for classifying the RMW, selecting appropriate 
packagings, assuring packagings are not overfilled, securing the 
closures on packagings, marking and labeling the packagings as 
appropriate, and generating shipping papers in accordance with the HMR. 
Workers in the health care facility who perform no offeror functions 
affecting the transportation safety of the shipment, but merely deposit 
medical waste in containers provided by the waste hauler, are not 
subject to HMR requirements. However, workers at a health care facility 
who perform offeror functions are subject to applicable requirements of 
the HMR. If a health care facility and a waste hauler split the 
performance of offeror functions, both the facility and the waste 
hauler are subject to the HMR as offerors.
    In the NPRM, we noted in the preamble that waste diagnostic 
specimens and waste biological products--diagnostic specimens and 
biological products meeting the definition for RMW--could not be 
transported under the exceptions proposed in the NPRM for these

[[Page 53127]]

materials. One commenter opposes this distinction, stating that 
excepted products should continue to be excepted from HMR requirements 
when their status changes to waste. The commenter states regulating a 
material differently at various stages places an undue and unrealistic 
burden on medical staff in the field. We disagree. By definition, RMW 
is a waste or reusable material containing or suspected of containing a 
Risk Group 2 or 3 infectious substance. If a diagnostic specimen is 
found not to contain a pathogen, then it is not subject to regulation 
as RMW. Similarly, if an excepted biological product is not 
contaminated during use or handling with an infectious material, then 
it is not subject to regulation as RMW. Laboratory workers, health care 
providers, and medical staff should have no problem identifying those 
diagnostic specimens or biological products meeting the RMW definition, 
and transporting them with other RMW generated by the facility.

I. Used Health Care Products

    In the NPRM we proposed to except from the HMR used health care 
products returned to the manufacturer, provided the products are 
shipped in a triple packaging conforming to certain manufacturing and 
marking requirements. The proposal required the primary and secondary 
containers to be marked with the OSHA BIOHAZARD symbol. In addition, we 
proposed to require the secondary container to be a watertight metal or 
plastic packaging designed and constructed in a manner to assure the 
used health care product and primary container remain intact during 
transportation. The NPRM proposed to require offerors and transporters 
of used health care products potentially contaminated with an 
infectious substance to be informed about the used health care product 
packaging requirements.
    Several commenters address this proposal. Most suggest that the 
proposal is too broad. Further, commenters suggest that, for purposes 
of the HMR, the definition of used health care products should be 
limited to used products contaminated with potentially infectious body 
fluids or materials. Transportation requirements should apply only to 
products where the infectious hazards cannot be removed or mitigated 
prior to transportation. We agree and modified this final rule 
accordingly.
    Commenters also suggest the packaging requirements for shipment of 
used health care products should be risk-based performance standards 
rather than triple-pack specification standards, as proposed in the 
NPRM. We agree. Therefore, in this final rule we are revising the 
packaging requirements proposed in the NPRM to provide more flexibility 
for shippers.
    Note that the person offering a used health care product for 
transportation under the HMR, not the original manufacturer of the 
product, is responsible for assuring compliance with the transportation 
requirements.

J. Hazard Communication

    In the NPRM, we proposed to require bulk packagings containing RMW 
to be marked with the appropriate UN identification number and with a 
BIOHAZARD marking. The BIOHAZARD marking would have to conform to OSHA 
specifications for the BIOHAZARD marking in 29 CFR 1910.1030(g)(1)(i) 
to communicate to emergency response personnel the nature of the 
material being transported. We proposed to require the size of the 
BIOHAZARD marking to measure at least 273 mm (10.8 inches) on each 
side. Two commenters note many states require a 152.4 mm (6 inches) 
size marking, and ask us to consider changing our proposed size 
requirement. We agree and modified this final rule accordingly. In 
addition, the final rule includes a graphic representation of the 
BIOHAZARD symbol.
    One commenter requests we allow a transition period for the new 
BIOHAZARD marking for bulk shipments of RMW, and for the marking 
requirements on inner packagings authorized for use inside bulk 
packagings authorized for the transportation of RMW. We agree. In this 
final rule we are specifying the effective date for both marking 
requirements as one year after the effective date of this final rule.
    One commenter suggests all unique marking requirements for 
infectious substances, including regulated medical wastes, should be 
consolidated into one section in subpart D of part 172, rather than 
located in sections authorizing exceptions from certain requirements or 
in packaging authorization sections. We disagree. Placing some marking 
requirements with authorized exceptions or with packaging authorization 
requirements helps shippers easily identify all requirements with which 
they must comply when preparing packages for transportation.
    Several commenters note certain packages of infectious substances 
may be subject to labeling requirements under both the HMR and the OSHA 
BIOHAZARD labeling requirements in 29 CFR 1910.1030. These commenters 
suggest we adopt a single labeling requirement, or we work 
cooperatively with OSHA to clarify that the OSHA BIOHAZARD label should 
not be used for transportation. While we agree with commenters that a 
dual labeling requirement for certain packages of infectious substances 
may be confusing, we determined that the OSHA BIOHAZARD label is not 
prohibited under Sec. 172.401 of the HMR. We do permit use of the 
BIOHAZARD label in place of the INFECTIOUS SUBSTANCE label under 
certain conditions. However, substituting the BIOHAZARD label for the 
INFECTIOUS SUBSTANCE label in all cases is not feasible. The INFECTIOUS 
SUBSTANCE label is consistent with labels authorized by the UN 
Recommendations and the ICAO Technical Instructions for international 
shipments of infectious substances. We do work with OSHA to minimize 
regulatory duplications and inconsistencies and will continue to do so.
    State, local, and tribal governments should be aware the Federal 
hazardous materials transportation law (Federal hazmat law; 49 U.S.C. 
5101 et seq.) contains an express preemption provision preempting 
state, local, and Indian tribe requirements on certain covered subjects 
(49 U.S.C. 5125(b)). 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.
    The marking of a hazardous material for purposes of transportation 
in commerce 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 
applicable to transportation in commerce is preempted when it is not 
``substantively the same'' as Federal hazmat law or a regulation issued 
under it. 49 U.S.C.

[[Page 53128]]

5125(b)(1). After August 14, 2003, non-Federal marking requirements 
applicable to hazardous materials transportation not substantively the 
same as the marking requirements for RMW included in this final rule 
are preempted, unless authorized by another Federal law or a waiver of 
preemption.

K. Training

    Several commenters addressed training requirements associated with 
the regulation of infectious substances under the HMR. Currently, 
Subpart H of Part 172 requires a hazmat employer to assure each of its 
hazmat employees is trained, including general awareness/
familiarization training, function-specific training, and safety 
training. A hazmat employee may not perform any function regulated 
under the HMR unless he or she is trained. One commenter states this 
level of training is infeasible and unnecessary for health care 
professionals, and suggests training should be more abbreviated and 
targeted to specific functions. This commenter further suggests we 
consider increasing the packaging integrity for shipments of infectious 
substances, in lieu of applying the hazmat employee training 
requirements to health care professionals.
    We disagree that application of the training requirements to health 
care professionals is ``infeasible'' and ``unnecessary.'' Training is 
essential to successful compliance with the HMR. Most health care 
professionals are already familiar with and trained in requirements 
that can be used to satisfy some training obligations under the HMR, 
such as the OSHA Universal Precautions procedures. Further, increased 
packaging integrity cannot be a substitute for training. Health care 
professionals need training to properly use any packaging authorized 
for the transportation of infectious substances, or the regulatory 
requirements would be meaningless. Moreover, for shipments conforming 
to requirements for materials of trade or diagnostic specimens in this 
final rule, the associated training requirements are minimal. They do 
not include the certification and record keeping provisions in subpart 
H of part 172.
    Another commenter recommends we specify the level of training 
required for health care professionals, and other offerors and 
transporters of infectious substances. We disagree. Flexibility is 
built into the HMR training requirements, allowing hazmat employers to 
determine the method of training and the level to which each employee 
must be trained. This flexibility helps to minimize the training burden 
on both hazmat employers and hazmat employees. This commenter also 
recommends we delay enforcement of the new requirements in this final 
rule to allow an appropriate period for retraining. Again, we disagree. 
This final rule is effective October 2, 2002; this should provide ample 
time to assure hazmat employees are trained in the new requirements.

L. Contaminated Food and Food Products

    One commenter states that the definition of ``infectious 
substance'' in Sec. 173.134, as proposed, could be read to require food 
and food ingredients tainted with salmonella to be shipped in 
accordance with requirements for transportation of infectious 
substances. Salmonella is listed in 42 CFR 72.3 as an infectious 
substance. This commenter notes salmonella-tainted food does not pose a 
significant, acute threat to transport workers or to the general public 
since it must normally be ingested to cause disease. This commenter 
suggests the final rule incorporate an exception from regulation for 
food and food ingredients tainted with salmonella or other bacteria. We 
agree. Indeed, there is no significant threat to life or property from 
the transportation of food, food ingredients, or food products 
contaminated with bacteria or other types of pathogens, particularly 
when such food is being transported as a result of a recall by the 
original processor. We modified the list of exceptions from HMR 
requirements in the final rule accordingly.

III. Section-by-Section Review

Part 171

Section 171.7

    We are revising 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 are required for plastic 
inner packagings used to transport RMW inside Large Packagings and non-
specification bulk packagings. We are also revising the table of 
informational material not requiring incorporation by reference. This 
revision will add three resources for shippers to use to assign a risk 
group to a specific infectious substance.

Section 171.8

    We are adding definitions for ``biological product,'' ``cultures 
and stocks,'' ``diagnostic specimen,'' ``risk group,'' ``sharps,'' and 
``toxin.'' These definitions refer readers to the definitions in 
Sec. 173.134 of the HMR.

Section 171.14

    We are allowing a two-year transition period for the revised 
Division 6.2 labels adopted in this final rule.

Section 171.15

    We are removing the term ``etiologic agents'' from paragraphs 
(a)(3) and (b) and replacing it with ``infectious substances.'' In 
addition, in paragraph (b) we are adding 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 are removing the 
letter ``D'' in column (1). In column (7), we are removing the 
reference to Special Provision A14 and revising columns (9A) and (9B) 
to replace ``Forbidden'' with ``No Limit'' for quantity limitations on 
board aircraft. These 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 bulk 
packagings authorized for the transportation of RMW can be found in 
Sec. 173.197 of the HMR. Finally, we are revising 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 are adding new 
special provisions in column (7). Special Provision A81 provides relief 
from quantity limits for the transport of body fluids containing 
infectious substances, when in primary receptacles not exceeding 1,000 
mL (34 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.
    In addition, we are adding 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 are also adding two new entries for ``Toxins, extracted from 
living sources, liquid, n.o.s., UN 3172'' and ``Toxins, extracted from 
living sources, solid, n.o.s., UN 3172.'' For both entries, a ``G'' in 
column (1) indicates that the

[[Page 53129]]

shipping description on shipping papers must include the technical 
names for the materials. Both entries indicate the materials are 
Division 6.1 materials, UN 3172, PG I, II, or III. We are adding 
Special Provision 141 to state that toxins containing infectious 
substances or 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 are revising this section by removing Special Provision A14, 
revising Special Provision A13, and adding Special Provisions 141, A81, 
and A82, as above detailed.

Section 172.323

    We are adding this section to require bulk packagings containing 
RMW to be marked with a BIOHAZARD marking conforming to OSHA 
regulations at 29 CFR 1910.1030. In response to comments, this final 
rule requires the size of the marking to be at least 152.4 mm (6 
inches) on each side. In this final rule, we are adding new paragraph 
(c) to require the BIOHAZARD marking to be displayed on a background of 
contrasting color. In addition, this final rule includes a graphic 
representation of the BIOHAZARD symbol.

Section 172.432

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

Section 172.502

    We are revising paragraph (b) to indicate the restrictions on 
placarding in paragraph (a) of this section do not apply to the display 
of a BIOHAZARD marking on a white square-on-point background.

Part 173

Section 173.6

    We are adding a MOTS exception for diagnostic specimens, biological 
products, and RMW, other than Risk Group 4 materials. The exception 
includes packaging requirements and quantity limitations. As suggested 
by commenters, this section incorporates minimum performance packaging 
standards for MOTS that are diagnostic specimens, biological products, 
or RMW.

Section 173.28

    We are adding a requirement for Division 6.2 packagings to be 
disinfected prior to reuse. As suggested by a commenter, this 
requirement is modified from the NPRM proposal to substitute the term 
``disinfect'' for ``decontaminate.''

Section 173.134

    In paragraph (a), we are revising the definitions and 
classification criteria for ``infectious substance,'' ``biological 
product,'' ``diagnostic specimen,'' and ``regulated medical waste;'' 
and adding definitions for ``cultures and stocks,'' ``risk group,'' 
``sharps,'' ``toxin,'' and ``used health care product.''
    We are revising 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. In response to comments, we revised the 
definition proposed in the NPRM for clarity and specificity.
    We are revising 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 are defining ``cultures and stocks'' to mean a material prepared 
and maintained for growth and storage, and containing a Risk Group 2, 
3, or 4 infectious substance.
    We are revising 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 and 
described by the proper shipping name ``Infectious Substance''. 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 are revising the definition for ``regulated medical waste'' to 
indicate regulated medical waste is a waste or reusable material 
containing or suspected to contain a Risk Group 2 or 3 infectious 
substance. 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 are adding a definition for ``risk group'' to mean a ranking of 
a micro-organism's ability to cause injury through disease. For 
consistency with terminology used by other entities that use risk group 
definitions, in this final rule the definition is modified to 
substitute ``the severity of the disease caused by the organism'' for 
``the pathogenicity of the organism'' as proposed in the NPRM. Thus, 
risk group assignment criteria include: the severity of the disease 
caused by 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 are defining ``sharps'' to mean any object that may be 
contaminated with an infectious substance, and is able to cut or 
penetrate the skin or packaging material. The term includes needles, 
syringes, scalpels, broken glass, culture slides, culture dishes, 
broken capillary tubes, broken rigid plastic, and exposed ends of 
dental wires. In response to comments, we have the definition proposed 
in the NPRM to include uncontaminated objects that may become 
contaminated during handling and transportation.
    We are defining ``toxin'' to mean a Division 6.1 material obtained 
from a plant, animal, or bacterial source. The definition notes toxins 
containing an infectious substance or contained in an infectious 
substance, must be classed as Division 6.2 materials.
    In paragraph (b), we are listing exceptions from the HMR 
requirements applicable to Division 6.2 materials. These exceptions 
include:
    1. Biological products subject to Federal approval, permit, or 
licensing requirements.
    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, including diagnostic specimens that do not contain a 
pathogen or in which the pathogen is inactivated or neutralized.
    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.
    9. Environmental microbiological samples collected to evaluate 
occupational and residential exposure risks.
    10. Agricultural and food products.
    In the NPRM, we proposed an exception from most HMR requirements 
for forensic material transported on behalf of the Federal government 
or a

[[Page 53130]]

state, local government, or tribal government agency, provided the 
material was shipped in a packaging conforming to the provisions of 
Sec. 173.24. After the NPRM was published, we discussed this exception 
with officials from the Federal Bureau of Investigation (FBI). We were 
particularly concerned with shipments of forensic material associated 
with bio-terrorism incidents. Based on our discussions with the FBI, 
this final rule modifies the exception proposed in the NPRM. This final 
rule requires forensic material known or suspected to contain a Risk 
Group 4 infectious substance or an infectious substance listed as a 
select agent in 42 CFR part 72 to be transported in packaging capable 
of meeting the HMR performance test standards for infectious substance 
packaging. In addition, the secondary packaging must be marked with a 
BIOHAZARD symbol conforming to specifications in 29 CFR 
1910.1030(g)(1)(i). An itemized list of contents must be enclosed 
between the secondary packaging and the outer packaging.
    We are also modifying the exception for medical waste generated 
from households, to indicate such medical waste must be transported in 
accordance with applicable state, local, or tribal government 
requirements.
    In addition, we are revising the exception for laundry or medical 
equipment conforming to OSHA regulations in 29 CFR 1910.1030. This 
final rule clarifies 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 this final rule, we modified the exception for blood and blood 
products to add human cell, tissues, and cellular and tissue-based 
products regulated under authority of the Public Health Service Act 
and/or the Food, Drug, and Cosmetic Act.
    In paragraph (c), we are modifying the exception for RMW 
transported by contract or private carriers, to include waste cultures 
and stocks containing Risk Group 2 or 3 infectious substances.
    Finally, we are adding paragraph (d) to clarify that if an item 
listed in paragraphs (b) or (c) of this section meets the definition of 
another hazard class, it must be offered for transportation and 
transported in accordance with applicable requirements of the HMR. 
Similarly, if an item listed in paragraphs (b) or (c) of this section 
is a hazardous substance, hazardous waste, or marine pollutant, it must 
be offered for transportation and transported in accordance with 
applicable requirements of the HMR.

Section 173.196

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

Section 173.197

    We are revising this section to authorize certain bulk packagings 
for the transportation of RMW. Paragraph (a) includes general 
requirements for non-bulk and bulk packagings. Paragraph (b) requires 
non-bulk packagings to conform to the requirements of part 178 at the 
Packing Group II performance level. Paragraphs (c) and (d) authorize 
Large Packagings and non-specification bulk containers for the 
transportation of RMW. Paragraph (c) sets forth conditions governing 
the use of Large Packagings. Paragraph (d) sets forth the conditions 
governing the use of non-specification carts and bulk outer packagings. 
Paragraph (e) specifies the inner packagings authorized for use with 
bulk outer packagings.

Section 173.199

    We are adding 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, 
as appropriate. Generally, all other diagnostic specimens may be 
shipped in triple packagings capable of passing a 1.2 meter (3.9 feet) 
drop test.
    Liquid diagnostic specimens must 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. The 
volumetric capacity of the outer packaging may not exceed 4 L (1 
gallon).
    Solid diagnostic specimens must 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).
    Shipments of used health care products contaminated with an 
infectious substance and being returned to the manufacturer, must be 
transported in triple packagings 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. In response to comments, we revised this section to 
provide more packaging flexibility.
    Diagnostic specimens and used health care products shipped in 
accordance with these provisions are not subject to most other 
requirements in the HMR. However, these shipments are subject to 
minimal training requirements. Further, diagnostic specimens are 
subject to incident reporting for shipments offered for transportation 
or transported by aircraft.

Part 177

Section 177.834

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

Section 177.843

    We are adding paragraph (d) to require a transport vehicle to be 
disinfected prior to reuse if a Division 6.2 material is released from 
its packaging inside the vehicle. As suggested by a commenter, we 
modified this requirement to substitute the term ``disinfect'' for 
``decontaminate.''

Part 178

Section 178.503

    We are adding paragraph (f) to incorporate markings for infectious 
substances packagings consistent with those in the ICAO Technical 
Instructions and the UN Recommendations.

Section 178.601

    We are adding 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, manufacturers of 
infectious substances packagings are required to retain design 
qualification records in accordance with Sec. 178.601(c)(l). In 
addition, we are adding a sentence to paragraph (c)(2) to indicate, 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 are adding a

[[Page 53131]]

sentence to paragraph (e) to require packagings used for transporting 
infectious substances to pass periodic retests.

Section 178.609

    We are revising the section heading to remove the wording 
``(etiologic agents).'' We are revising 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 are 
revising paragraph (e) to replace the current water immersion test with 
a water spray test to simulate exposure to rainfall consistent with the 
ICAO Technical Instructions. We are revising paragraphs (h)(1) and 
(h)(2) to clearly indicate that, during the penetration test, 
penetration of the primary receptacle is not acceptable. We are 
deleting current paragraph (i). We are adding 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.

IV. Coordination with Other Federal Agencies

    In addition to RSPA, several Federal agencies have responsibility 
for regulating infectious substances. We provided CDC, USDA, FDA, EPA, 
and OSHA with copies of this final rule in advance of publication in 
the Federal Register for their information and comment. We asked them 
specifically to identify potential areas of conflict between their 
regulations and the provisions of this final rule. None of these 
agencies identified any potentially conflicting regulatory 
requirements.

V. Security Issues

    As a result of the terrorist attacks of September 11, 2001, and 
subsequent threats related to biological materials, we are reviewing 
the HMR to determine if additional requirements are necessary to assure 
the security of hazardous materials in transportation. Certain 
infectious substances, including Bacillus anthracis (anthrax) and other 
materials listed as select agents by the CDC (42 CFR part 72), are 
materials that may pose a potential security risk. We initiated a 
project to address security issues related to infectious substances and 
other hazardous materials to determine if rulemaking action is 
necessary.

VI. Regulatory Analyses and Notices

A. Executive Order 12866 and DOT Regulatory Policies and Procedures

    This final rule is considered a significant regulatory action under 
Executive Order 12866, and the Regulatory Policies and Procedures of 
the Department of Transportation (44 FR 11034). A regulatory evaluation 
is available for review in the public docket.
    The costs identified in the regulatory evaluation are minimal. They 
are primarily attributed to the regulation of shipments of diagnostic 
specimens containing a Risk Group 2, 3 or 4 pathogen and of new 
specification packaging requirements for infectious substances. Our 
estimate of costs is for a one-time initial cost of $33,332, and a 
subsequent annual cost of $28,351.
    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 this final rule. 
Reported incidents to RSPA between 1990 and the present resulted in 2 
minor injuries and $3,281 in property damage. However, we believe that 
incidents are significantly under-reported.
    Benefits resulting from implementation of this final rule include 
the following:
    1. International harmonization. Harmonization of requirements in 
the HMR with standards specified in the UN Recommendations, ICAO 
Technical Instructions, and IMDG Code will remove current 
inconsistencies among the regulations. This action will facilitate 
efficient transportation of infectious substances across national 
borders. More importantly, harmonized regulations reduce the potential 
for misunderstanding and confusion, enhancing 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 entire 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 potentially infectious diagnostic 
specimens and biological products should be transported in authorized 
packaging. Further, such shipments should include communication of 
hazard to those who may come into contact with them. The HMIS data base 
and anecdotal information indicate packages of these currently excepted 
materials are sometimes damaged during transportation. This damage can 
result in delays and possible risk to cargo handlers, flight crews, 
emergency responders, and the general public. The requirements in this 
final rule for more stringent packaging for these materials, combined 
with the exceptions for transportation of these materials as MOTS or by 
private or contract carriers in dedicated vehicles will assure swift 
and efficient transportation. This final rule will also reduce the 
risks to transportation workers and the general public. Enhancements to 
packaging 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 enhances overall 
safety while imposing insignificant costs on the regulated industry.
    Although we cannot assign definitive dollar amounts to these 
potential benefits, we believe the final rule adopts the least costly 
alternatives available for ensuring an acceptable level of 
transportation safety, and the potential benefits to society exceed the 
potential costs associated with this final rule.

B. Executive Order 13132

    This final rule has been analyzed in accordance with the principles 
and criteria contained in Executive Order 13132 (``Federalism''). This 
final rule preempts state, local, and Indian tribe requirements, but 
does not propose any regulation with 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 that preempts state, 
local, and Indian tribe requirements on certain covered subjects (49 
U.S.C. 5125(b)). 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

[[Page 53132]]

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 final rule addresses covered subject items 1-5 above and 
preempts state, local, and Indian tribe requirements not meeting the 
``substantively the same'' standard. This final 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 
Sec. 5125(b)(2) that, if we issue a regulation concerning any of the 
covered subjects, we 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. The 
effective date of Federal preemption is one year from publication of 
this final rule in the Federal Register.

C. Executive Order 13175

    This final rule has been analyzed in accordance with the principles 
and criteria contained in Executive Order 13175 (``Consultation and 
Coordination with Indian Tribal Governments''). This final rule does 
not have tribal implications, does not impose substantial direct 
compliance costs, and is not required by statute. Consequently, the 
funding and consultation requirements of Executive Order 13175 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 a rule is not expected to have a 
significant impact on a substantial number of small entities. Based on 
the assessment in the regulatory evaluation, I hereby certify that 
while this final rule applies to a substantial number of small 
entities, there will not be a significant economic impact on those 
small entities. 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 annual costs 
attributed to this final rule are minimal, especially when compared to 
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.

E. Paperwork Reduction Act

    RSPA has current information collection approvals under OMB No. 
2137-0039, Hazardous Materials Incident Reports, which expires May 31, 
2004, with 34,441 burden hours and $825,621.66 annual costs; and OMB 
No. 2137-0557, Approvals for Hazardous Materials, which expires May 31, 
2004, with 18,405 burden hours and $415,237.40 annual costs. This final 
rule will result in small increases in annual burden hours and costs.
    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 record keeping 
requests. The NPRM identified and requested comment on revised 
information collections submitted to OMB for approval. We estimated the 
total information collection and record keeping burden as proposed in 
the NPRM would be revised as follows:
    OMB No. 2137-0039:
    Number of Respondents: 1,536.
    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 received no comments on these revised information collections. 
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. OMB approved the revised information collections 
proposed in the NPRM on May 4, 2001, and May 9, 2001.

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

H. Environmental Assessment

    We find there are no significant environmental impacts associated 
with this final rule. An environmental assessment is in the public 
docket for this rulemaking.

List of Subjects

49 CFR Part 171

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

49 CFR Part 172

    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 are amending 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 continues 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 
are added in alphanumeric sequence under the American Society for 
Testing and

[[Page 53133]]

Materials, and three new entries are added in alphabetical order to the 
table in paragraph (b), 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 1709-01 Standard Test Methods for Impact Resistance       173.197
 of Plastic Film by the Free-Falling Dart Method...........
 
*                  *                  *                  *
                  *                  *                  *
ASTM D 1922-00a Standard Test Method for Propagation Tear        173.197
 Resistance of Plastic Film and Thin Sheeting by Pendulum
 Method....................................................
 
*                  *                  *                  *
                  *                  *                  *
------------------------------------------------------------------------

* * * * * * *
    (b) List of informational materials not requiring incorporation by 
reference. * * *

------------------------------------------------------------------------
                                                                49 CFR
                Source and name of material                   reference
------------------------------------------------------------------------
American Biological Safety Association 1202 Allanson Road,
 Mundelein, IL 60060
    Risk Group Classification for Infectious Agents, 1998..      173.134
 
*                  *                  *                  *
                  *                  *                  *
Centers for Disease Control and Prevention 1600 Clifton
 Road, Atlanta, GA 30333
    Biosafety in Microbiological and Biomedical                  173.134
     Laboratories, Fourth Edition, April 1999..............
 
*                  *                  *                  *
                  *                  *                  *
National Institutes of Health Bethesda, MD 20892
    NIH Guidelines for Research Involving Recombinant DNA        173.134
     Molecules (NIH Guidelines), January 2001, Appendix B..
 
*                  *                  *                  *
                  *                  *                  *
------------------------------------------------------------------------


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


Sec. 171.8  Definitions 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.
* * * * *
    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 is amended by adding paragraph (e) to read as 
follows:


Sec. 171.14  Transitional provisions for implementing certain 
requirements.

* * * * *
    (e) A Division 6.2 label conforming to specifications in 
Sec. 172.432 of this subchapter in effect on September 30, 2002, may be 
used until October 1, 2005.


Sec. 171.15  [Amended]

    5. In Sec. 171.15, the following changes are made:
    a. Paragraph (a)(3) is amended by removing the term ``(etiologic 
agents)''.
    b. Paragraph (b) introductory text is amended by removing the term 
``etiologic agents'' and in its place adding the term ``infectious 
substances'', and 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 continues 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 are 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.

* * * * *

[[Page 53134]]



                                                                            Sec.  172.101.--Hazardous Materials Table
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                 (8)  Packaging (Sec.  173.***)           (9)  Quantity          (10)  Vessel
                  Hazardous                                                                                 ---------------------------------------        limitations              stowage
                  materials        Hazard     Identification                                      Special                                          ---------------------------------------------
   Symbols     descriptions and   class or        Numbers           PG          Label Codes      provisions                                          Passenger      Cargo
               proper shipping    Division                                                                    Exceptions    Non-bulk       Bulk      aircraft/     aircraft     Location   Other
                    names                                                                                                                               rail         only
(1)           (2)..............         (3)  (4).............  (5).........  (6)..............  (7)........  (8A).......  (8B).......  (8C).......  (9A).......  (9B).......  (10A)......  (10B)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
              [Add]............
                                       *                  *                  *                  *                  *                  *                  *
              Diagnostic                6.2  ................  ............  .................  A82........  134........  199........  None.......  4 L or 4kg.  4L or 4 kg.  A..........   40
               specimen.
                                       *                  *                  *                  *                  *                  *                  *
G...........  Toxins, from              6.1  UN3172..........  I...........  6.1..............  141........  None.......  201........  243........  1 L........  30 L.......  B..........   40
               living sources,                                 II..........                     141........  None.......  202........  243........  5 L........  60 L.......  B..........   40
               liquid, n.o.s..                                 III.........                     141........  153........  203........  241........  60 L.......  220L.......  A..........   40
G...........  Toxins, from              6.1  UN3172..........  I...........  6.1..............  141........  None.......  211........  243........  5 kg.......  50 kg......  B..........
               living sources,                                 II..........                     141........  None.......  212........  243........  25 kg......  100 kg.....  B..........
               solid, n.o.s..                                  III.........                     141........  153........  213........  241........  100 kg.....  200 kg.....  A..........
                                       *                  *                  *                  *                  *                  *                  *
              [Revise].........
G...........  Infectious                6.2  UN2900..........  ............  6.2..............  A81, 82....  134........  196........  None.......  50 mL or 50  4 L or 4 kg  B..........   40
               substances,                                                                                                                           g.
               affecting
               animals only.
G...........  Infectious                6.2  UN2814..........  ............  6.2..............  A81, 82....  134........  196........  None.......  50 mL or 50  4 L or 4 kg  B..........   40
               substances,                                                                                                                           g.
               affecting humans.
                                       *                  *                  *                  *                  *                  *                  *
              Regulated medical         6.2  UN3291..........  II..........  6.2..............  A13........  134, 197...  197........  197........  No Limit...  No Limit...  A..........   40
               waste.
                                       *                  *                  *                  *                  *                  *                  *
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 53135]]


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


Sec. 172.102  Special provisions.

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

Code/Special Provisions

* * * * *
    141  A toxin obtained from a plant, animal, or bacterial source 
containing an infectious substance, or a toxin contained in an 
infectious substance, must be classed as Division 6.2, described as 
an infectious substance, 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 body fluids known to contain or suspected of containing an 
infectious substance when transported in primary receptacles not 
exceeding 1,000 mL (34 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. Section 172.323 is added to read as follows:


Sec. 172.323  Infectious substances.

    (a) In addition to other requirements of this subpart, after 
September 30, 2003, 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 conforming 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 152.4 mm (6 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 152.4 mm (6 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.
    (c) The background color for the BIOHAZARD marking required by 
paragraph (a) of this section must be orange and the symbol and letters 
must be black. Except for size the BIOHAZARD marking must appear as 
follows:

[[Page 53136]]

[GRAPHIC] [TIFF OMITTED] TR14AU02.005

    (d) The BIOHAZARD marking required by paragraph (a) of this section 
must be displayed on a background of contrasting color. It may be 
displayed on a plain white square-on-point configuration having the 
same outside dimensions as a placard, as specified in Sec. 172.519(c) 
of this part.

    10. In Sec. 172.432, the illustration in paragraph (a) is revised 
to read as follows:


Sec. 172.432  INFECTIOUS SUBSTANCE label.

    (a) * * *

[[Page 53137]]

[GRAPHIC] [TIFF OMITTED] TR14AU02.006

* * * * *
    11. In Sec. 172.502, paragraph (b)(2) is revised to read as 
follows:


Sec. 172.502  Prohibited and permissive placarding.

* * * * *
    (b) * * *
    (2) The restrictions of paragraph (a) of this section do not apply 
to the display of a BIOHHAZARD marking, a ``HOT'' marking, or an 
identification number on a white square-on-point configuration in 
accordance with Secs. 172.323(c), 172.325(c), or 172.336(b) of this 
part, respectively.
* * * * *

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

    12. The authority citation for part 173 continues to read as 
follows:

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


    13. In Sec. 173.6, paragraph (a)(4) is redesignated as paragraph 
(a)(5), and a new paragraph (a)(4) is added to read as follows:


Sec. 173.6  Materials of trade exceptions.

* * * * *
    (a) * * *
    (4) 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. For 
liquids, the inner packaging must be leak tight, and the outer 
packaging must contain sufficient absorbent material to absorb the 
entire contents of the inner packaging. For sharps, the inner packaging 
must be constructed of a rigid material resistant to punctures and 
leaks. For all Division 6.2 materials, the outer packaging must be a 
strong, tight packaging securely closed and secured against movement.
    (i) For a diagnostic specimen or biological product, combination 
packagings must conform to the following capacity limitations:
    (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) For a regulated medical waste, a combination packaging must 
consist of one or more inner packagings having a gross mass or capacity 
not exceeding 4 kg (8.8 pounds) or 4 L (1 gallon), and an

[[Page 53138]]

outer packaging having a gross mass or capacity not exceeding 16 kg 
(35.2 pounds) or 16 L (4.2 gallons).
* * * * *

    14. Section 173.28 is amended by adding paragraph (f) to read as 
follows:


Sec. 173.28  Reuse, reconditioning and remanufacture of packagings.

* * * * *
    (f) A Division 6.2 packaging to be reused must be disinfected prior 
to reuse by any means effective for neutralizing the infectious 
substance the packaging previously contained. A secondary packaging or 
outer packaging conforming to the requirements of Sec. 173.196 or 
Sec. 173.199 need not be disinfected prior to reuse if no leakage from 
the primary receptacle has occurred.

    15. Section 173.134 is revised to read as follows:


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

    (a) Definitions and classification criteria. For purposes 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. A pathogen is a virus or 
micro-organism (including its viruses, plasmids, or other genetic 
elements, if any) or a proteinaceous infectious particle (prion) that 
has the potential to cause 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 a risk group 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. Infectious substances are subject to applicable requirements in 
42 CFR Part 72--Interstate Shipment of Etiologic Agents.
    (2) Biological product means a virus, therapeutic serum, toxin, 
antitoxin, vaccine, blood, blood component or derivative, allergenic 
product, or analogous product used in the prevention, diagnosis, 
treatment, or cure of diseases in humans or animals. A biological 
product includes a material manufactured and distributed in accordance 
with one of the following provisions: 9 CFR part 102 (Licenses for 
Biological Products); 9 CFR part 103 (Experimental Products, 
Distribution, and Evaluation of Biological Products Prior to 
Licensing); 9 CFR part 104 (Permits for Biological Products); 21 CFR 
part 312 (Investigational New Drug Application); 21 CFR part 314 
(Applications for FDA Approval to Market a New Drug); 21 CFR parts 600 
to 680 (Biologics); or 21 CFR part 812 (Investigational Device 
Exemptions). A biological product known to contain or suspected of 
containing a pathogen in Risk Group 2, 3, or 4 must be classed as 
Division 6.2, described as an infectious substance, and assigned to UN 
2814 or UN 2900, as appropriate, unless otherwise excepted.
    (3) Cultures and stocks means a material prepared and maintained 
for growth and storage and containing 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 pathogen, in which case it must be classed as 
Division 6.2, described as an infectious substance, and 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 
known to contain or suspected of containing an infectious substance in 
Risk Group 2 or 3 and 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, described as an infectious substance, and assigned to 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 severity 
of the disease caused by 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 to        Risk to the
   Risk group           Pathogen          individuals       community
------------------------------------------------------------------------
4...............  A pathogen that       High...........  High.
                   usually causes
                   serious 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       High...........  Low.
                   usually causes
                   serious 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   Moderate.......  Low.
                   cause human or
                   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      None or very     None or very
                   that is unlikely to   low.             low.
                   cause human or
                   animal disease. A
                   material containing
                   only such micro-
                   organisms is not
                   subject to the
                   requirements of
                   this subchapter.
------------------------------------------------------------------------


[[Page 53139]]

    (7) Sharps means any object contaminated with a pathogen or that 
may become contaminated with a pathogen through handling or during 
transportation and also capable of cutting or penetrating skin or a 
packaging material. Sharps includes needles, syringes, 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 from a plant, animal, or 
bacterial source. A toxin containing an infectious substance or a toxin 
contained in an infectious substance must be classed as Division 6.2, 
described as an infectious substance, and assigned to UN 2814 or UN 
2900, as appropriate.
    (9) Used health care product means a medical, diagnostic, or 
research device or piece of equipment, or a personal care product used 
by consumers, medical professionals, or pharmaceutical providers that 
does not meet the definition of a diagnostic specimen, biological 
product, or regulated medical waste, is contaminated with potentially 
infectious body fluids or materials, and is not decontaminated or 
disinfected to remove or mitigate the infectious hazard prior to 
transportation.
    (b) Exceptions. The following are not subject to the requirements 
of this subchapter as Division 6.2 materials:
    (1) A biological product known to contain or suspected of 
containing a micro-organism in Risk Group 1, or that does not contain a 
pathogen.
    (2) A diagnostic specimen known to contain or suspected of 
containing a micro-organism in Risk Group 1, or that does not contain a 
pathogen, or a diagnostic specimen in which the pathogen has been 
neutralized or inactivated so it cannot cause disease when exposure to 
it occurs.
    (3) A biological product, including an experimental product or 
component of a product, subject to Federal approval, permit, 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.
    (4) Blood collected for the purpose of blood transfusion or the 
preparation of blood products; blood products; tissues or organs 
intended for use in transplant operations; and human cell, tissues, and 
cellular and tissue-based products regulated under authority of the 
Public Health Service Act and/or the Food, Drug, and Cosmetic Act.
    (5) Blood collected for the purpose of blood transfusion or the 
preparation of blood products and sent for testing as part of the 
collection process, except where the person collecting the blood has 
reason to believe it contains an infectious substance, in which case 
the test sample must be shipped in accordance with Sec. 173.199.
    (6) 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 or contamination. 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.
    (7) Laundry or medical equipment conforming 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 
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 being transported 
for disposal.
    (8) A material, including waste, that previously contained an 
infectious substance that has been treated by steam sterilization, 
chemical disinfection, or other appropriate method, so it no longer 
meets the definition of an infectious substance.
    (9) A living person.
    (10) 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.
    (11) Corpses, remains, and anatomical parts intended for interment, 
cremation, or medical research at a college, hospital, or laboratory.
    (12) Forensic material transported on behalf of a U.S. Government, 
state, local or Indian tribal government agency, except that--
    (i) Forensic material known or suspected to contain a Risk Group 2 
or 3 infectious substance must be shipped in a packaging conforming to 
the provisions of Sec. 173.24.
    (ii) Forensic material known or suspected to contain a Risk Group 4 
infectious substance or an infectious substance listed as a select 
agent in 42 CFR Part 72 must be transported in packaging capable of 
meeting the test standards in Sec. 178.609 of this subchapter. The 
secondary packaging must be marked with a BIOHAZARD symbol conforming 
to specifications in 29 CFR 1910.1030(g)(1)(i). An itemized list of 
contents must be enclosed between the secondary packaging and the outer 
packaging.
    (13) Environmental microbiological samples, such as a sample of 
dust from a ventilation system or mold from a wallboard, collected to 
evaluate occupational and residential exposure risks.
    (14) Agricultural products and food as defined in the Federal Food, 
Drug, and Cosmetics Act.
    (c) Exceptions for regulated medical waste. The following 
provisions apply to the transportation of regulated medical waste:
    (1) A regulated medical waste 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. 
Medical or clinical equipment and laboratory products may be 
transported aboard the same vehicle provided they are properly packaged 
and secured against exposure or contamination.

[[Page 53140]]

    (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.

    16. Section 173.196 is 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 consisting of the following components:
    (1) A watertight primary receptacle.
    (2) A watertight secondary packaging. If multiple fragile 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 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 producing a pressure differential of not less than 
95 kPa (0.95 bar, 14 psi).
    (7) The primary receptacle or secondary packaging used for 
infectious substances must be capable of withstanding without leakage 
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 (freeze-dried) 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 must be provided, 
such as heat seal, skirted stopper, or metal crimp seal. 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(a) 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 
containing or 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 meeting the requirements of Sec. 173.197.

    17. Section 173.197 is revised to read as follows:


Sec. 173.197  Regulated medical waste.

    (a) General provisions. Non-bulk packagings, large packagings, and 
bulk outer packagings used for the transportation of regulated medical 
waste must be rigid containers meeting the provisions of subpart B of 
this part.
    (b) Non-bulk packagings. Except as otherwise provided in 
Sec. 173.134 of this subpart, non-bulk packagings for regulated medical 
waste must be DOT specification packagings conforming to the 
requirements of Part 178 of this subchapter at the Packing Group II 
performance level. A non-bulk 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) intended to be transported in the packagings.
    (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 the waste 
is contained in inner packagings conforming to the requirements of 
paragraph (e) of this section. Each Large Packaging design 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. Only 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.

[[Page 53141]]

    (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 design intended for the transportation 
of sharps containers must be puncture resistant and capable of 
retaining liquids. The design must also be tested and certified as 
meeting 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) Regulated medical waste in each Cart or BOP must be contained 
in non-bulk inner packagings conforming to paragraph (e) of this 
section.
    (ii) Each Cart or BOP must have smooth, non-porous interior 
surfaces free of cracks, crevices, and other defects that could damage 
plastic film inner packagings or impede disinfection operations.
    (iii) Except as otherwise provided in this paragraph (d), each Cart 
or BOP must be used exclusively for the transportation of regulated 
medical waste. Prior to reuse, each Cart or BOP must be disinfected by 
any means effective for neutralizing the infectious substance the 
packaging previously contained.
    (iv) Untreated cultures and stocks of infectious substances 
containing 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 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 containing 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 conforming 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 with a 
nominal volume not exceeding 1,655 L (437 gallons).
    (ii) Each Cart must be constructed of metal, rigid plastic, or 
fiberglass fitted with a lid to prevent 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 to prevent the 
intrusion of water (e.g., rain or snow).
    (iii) Each opening in a BOP must be fitted with a closure to 
prevent 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 to 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 containing 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. After September 30, 2003, 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 1709-01, 
Standard Test Methods for Impact Resistance of Plastic Film by the 
Free-Falling Dart Method (see Sec. 171.7 of this subchapter), and for 
impact resistance in ASTM D 1922-00a, Standard Test Method for 
Propagation Tear Resistance of Plastic Film and Thin Sheeting by 
Pendulum Method (see Sec. 171.7 of this subchapter). 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 transported in a Large 
Packaging, Cart, or BOP must be packaged in a rigid inner packaging 
conforming to the requirements of paragraph (a) of this section. Liquid 
materials are not authorized for transportation in inner packagings 
having a capacity greater than 19 L (5 gallons).
    (3) Sharps. Sharps transported in a Large Packaging, Cart, or BOP 
must be packaged in a puncture-resistant inner packaging (sharps 
container). Each sharps container exceeding 76 L (20 gallons) in volume 
must be capable of passing the performance tests in Sec. 178.601 of 
this subchapter at the Packing Group II performance level. A sharps 
container may be reused only if it conforms to the following criteria:
    (i) The sharps container is specifically approved and certified by 
the U.S. Food and Drug Administration as a medical device for reuse.
    (ii) The sharps container must be permanently marked for reuse.
    (iii) The sharps container must be disinfected prior to reuse by 
any means

[[Page 53142]]

effective for the infectious substance the container previously 
contained.
    (iv) The sharps container must have a capacity greater than 7.57 L 
(2 gallons) and not greater than 151.42 L (40 gallons) in volume.

    18. A new Sec. 173.199 is added to read as follows:


Sec. 173.199  Diagnostic specimens and used health care products.

    (a) Diagnostic specimens. Except as provided in this paragraph (a), 
diagnostic specimens are excepted from all 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 meeting 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). The outer packaging 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:
    (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, conforming 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 leakproof.
    (4) The outer packaging may not exceed 4 kg (8.8 pounds) capacity.
    (d) Used health care products. A used health care product being 
returned to the manufacturer or the manufacturer's designee is 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 primary container 
designed and constructed to assure that it remains intact under 
conditions normally incident to transportation. For a used health care 
product capable of cutting or penetrating skin or packaging material, 
the primary container 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 conforming to 
29 CFR 1910.1030(g)(1)(i).
    (2) Each primary container must be placed inside a watertight 
secondary container designed and constructed to assure that it remains 
intact under conditions normally incident to transportation. The 
secondary container must be marked with a BIOHAZARD marking conforming 
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 know about the requirements of this section.

PART 177--CARRIAGE BY PUBLIC HIGHWAY

    19. The authority citation for part 177 continues to read as 
follows:

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

    20. In Sec. 177.834, paragraphs (a) and (g) are 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 and containing 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 
loaded to minimize the likelihood of damage thereto during 
transportation.
* * * * *

    21. In Sec. 177.843, paragraph (d) is added to read as follows:


Sec. 177.843  Contamination of vehicles.

* * * * *
    (d) Each transport vehicle used to transport Division 6.2 materials 
must be

[[Page 53143]]

disinfected prior to reuse if a Division 6.2 material is released from 
its packaging during transportation. Disinfection may be by any means 
effective for neutralizing the material released.

PART 178--SPECIFICATIONS FOR PACKAGINGS

    22. The authority citation for part 178 continues to read as 
follows:

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

    23. In Sec. 178.503, paragraph (f) is added to read as follows:


Sec. 178.503  Marking of packagings.

* * * * *
    (f) A manufacturer must mark every UN specification package 
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 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 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.

    24. In Sec. 178.601, paragraphs (c)(1), (c)(2), and (e) are 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 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.
* * * * *
    25. In Sec. 178.609, the section heading, the text of 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) are 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, 
categorizes 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 that 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;
* * * * *
    (iii) Flat on the longest side;
    (iv) Flat on the shortest side; and
* * * * *
    (e) The samples must be subjected to a water spray to simulate 
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). For a successful test, 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 the steel rod will impact 
the primary receptacle(s). For a successful test, 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

[[Page 53144]]

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.
    (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, DC, on August 2, 2002, under authority 
delegated in 49 CFR part 106.
Ellen G. Engleman,
Administrator, Research and Special Programs Administration.
[FR Doc. 02-20118 Filed 8-13-02; 8:45 am]
BILLING CODE 4910-60-P