[Federal Register Volume 71, Number 106 (Friday, June 2, 2006)]
[Rules and Regulations]
[Pages 32244-32263]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-4992]



[[Page 32243]]

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Part III





Department of Transportation





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Pipeline and Hazardous Materials Safety Administration



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49 CFR Parts 171, 172, 173, and 175



Hazardous Materials: Infectious Substances; Harmonization With the 
United Nations Recommendations; Final Rule

  Federal Register / Vol. 71, No. 106 / Friday, June 2, 2006 / Rules 
and Regulations  

[[Page 32244]]


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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

49 CFR Parts 171, 172, 173, and 175

[Docket No. PHMSA-2004-16895 (HM-226A)]
RIN 2137-AD93


Hazardous Materials: Infectious Substances; Harmonization With 
the United Nations Recommendations

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA), 
Department of Transportation (DOT).

ACTION: Final rule.

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SUMMARY: PHMSA is revising the transportation requirements for 
infectious substances, including regulated medical waste, to adopt new 
classification criteria, new exceptions, and packaging and hazard 
communication requirements consistent with revised international 
standards and to clarify existing requirements to promote compliance. 
These revisions will ensure an acceptable level of safety for the 
transportation of infectious substances and facilitate domestic and 
international transportation.

EFFECTIVE DATE: This final rule is effective October 1, 2006.
    Voluntary Compliance Date: Voluntary compliance is authorized 30 
days following publication of this final rule.

FOR FURTHER INFORMATION CONTACT: Eileen Edmonson, Office of Hazardous 
Materials Standards, (202) 366-8553, Pipeline and Hazardous Materials 
Safety Administration, U.S. Department of Transportation or by e-mail 
to [email protected] or [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On May 19, 2005, the Pipeline and Hazardous Materials Safety 
Administration (PHMSA), published a notice of proposed rulemaking 
(NPRM) to revise the requirements in the Hazardous Materials 
Regulations (HMR; 49 CFR parts 171-180) applicable to the 
transportation of infectious substances affecting humans and animals, 
including regulated medical waste (67 FR 53118). In the NPRM, PHMSA 
proposed to harmonize the HMR requirements applicable to the 
transportation of Division 6.2 materials with requirements in the 13th 
and 14th Editions of the UN Recommendations for the Transport of 
Dangerous Goods (UN Recommendations), the 2005-2006 Edition of the 
International Civil Aviation Organization Technical Instructions for 
the Safe Transport of Dangerous Goods by Air (ICAO Technical 
Instructions), and the International Maritime Organization Dangerous 
Goods Code. Specifically, we proposed to:
     Revise the classification system for Division 6.2 
materials from the current four-tiered risk group system to a two-
tiered system--Category A and Category B.
     Replace the proper shipping name ``Diagnostic specimens'' 
with ``Biological substance, Category B.''
     Adopt packaging requirements for Category A and Category B 
infectious substances consistent with those in the UN Recommendations 
and ICAO Technical Instructions.
     For Category B infectious substances, require the name, 
address, and telephone number of a person knowledgeable about the 
Category B infectious substance to be provided on a written document, 
such as an air waybill, accompanying the shipment or on the package.
     Permit a sample of an unknown infectious substance shipped 
for analysis or diagnosis to be transported as a Category B infectious 
substance, unless there is a strong suspicion that the unknown 
infectious substance meets the criteria for Category A, in which case 
the unknown material must be transported as a Category A infectious 
substance.
     Require sharps packagings to be securely closed and 
leakproof in all orientations.
     Require the development and implementation of 
transportation security plans for select agents and toxins affecting 
animals, as identified in 9 CFR part 121.
    The comment period for the proposed rule closed on July 18, 2005. 
PHMSA received 13 comments, all of which support revising the 
requirements to harmonize them with current international standards. 
The following companies, organizations, and individuals submitted 
comments: Gary Gilliam (Gilliam; RSPA-2004-16889-2); Alcoa, Inc. 
(Alcoa; RSPA-2004-16889-3); Steven V. Schulte (Schulte; RSPA-2004-
16889-4); The Daniels Corporation (Daniels; RSPA-2004-16889-6); Shoolah 
Escott (Escott; RSPA-2004-16889-7); National Solid Waste Management 
Association/Medical Waste Institute (NSWAM/MWI; RSPA-2004-16889-8); 
American Blood Centers (ABC; RSPA-2004-16889-9); Air Transport 
Association of America, Inc. (ATA; RSPA-2004-16889-10); Stericycle, 
Inc; (Stericycle; RSPA-2004-16889-11); JBM Associates, Inc. (JBM; RSPA-
2004-16889-12); American Clinical Laboratory Association (ACLA; RSPA-
2004-16889-13); Air Line Pilots Association (ALPA; RSPA-2004-16889-14); 
and TEN-E Packaging Services, Inc. (TEN-E; RSPA-2004-16889-15 and -16).

II. Discussion of Comments

A. Classification of Division 6.2 Materials

    The HMR currently incorporate a risk-group-based classification 
system for infectious substances. The regulations require Division 6.2 
materials to be assigned to risk groups based on the degree to which 
they cause injury through disease, with Risk Group 1 presenting the 
lowest risk and Risk Group 4 presenting the highest risk. Assignment of 
an infectious substance to a risk group is based on the known medical 
history of the source patient or animal, endemic local conditions, 
symptoms of the source patient or animal, or professional judgment 
concerning individual circumstances of the source patient or animal. 
Division 6.2 materials assigned to Risk Group 1 are excepted from the 
HMR and the UN Recommendations.
    The current requirements for assigning pathogens to risk groups are 
based on the risks posed in the laboratory environment, not in the 
transportation environment. Pathogens in transport do not pose the same 
level of risk that they do in the laboratory. Laboratory workers 
perform extensive manipulations of infectious substances that place the 
workers at higher risk of infection because of accidental exposures 
caused by splashes or spills. Moreover, certain laboratory processes--
such as vortexing, mixing, or centrifuging--can generate aerosols or 
airborne particles that can place workers who perform such operations 
at increased risk. These conditions do not exist in transport.
    The risk group classification system resulted in transportation 
problems, including shipper confusion in assigning risk groups, and 
shipment delays or refusal to transport associated with carriers' and 
transport workers' perceptions about the risks associated with the 
transportation of infectious substances. A delay in transportation or a 
refusal to transport a specimen may have life-threatening implications 
for a patient or a population. Moreover, transportation problems can 
delay research necessary to develop treatments or slow the spread of 
disease, and can interfere with the

[[Page 32245]]

implementation of appropriate measures to address new disease 
outbreaks. Because of these transportation problems, the UN Committee 
of Experts on the Transport of Dangerous Goods worked with scientists 
and public health professionals at the World Health Organization (WHO), 
the U.S. Centers for Disease Control and Prevention (CDC), and other 
agencies to develop a classification scheme for infectious substances 
that would be more appropriate for the transportation environment.
    In December 2002, the United Nations adopted a number of revisions 
for the 13th Revised Edition of the UN Recommendations related to the 
transportation of infectious substances, primarily involving how 
infectious substances are classed and packaged. In July 2004, the UN 
Committee of Experts on Dangerous Goods recommended further revisions 
to these standards; these revisions were adopted for the 14th Revised 
Edition of the UN Recommendations in December 2004. At the same time, 
the ICAO Dangerous Goods panel adopted many of the amendments for the 
14th Revised Edition of the UN Recommendations in the 2005-2006 Edition 
of the ICAO Technical Instructions through an addendum to the ICAO 
Technical Instructions.
    The amendments in the 13th and 14th Editions of the UN 
Recommendations are the result of long and thoughtful consultations 
among regulators, scientists, medical professionals, and the transport 
community. The result is a set of standards for the transportation of 
infectious substances that are easier to use and impose a high level of 
safety appropriate to the degree of risk and conditions of transport. 
PHMSA's May 9, 2005 NPRM proposed to harmonize HMR requirements for the 
transportation of infectious substances with the international 
standards.
    Commenters generally support PHMSA's efforts to more closely align 
the requirements for transporting infectious substances with current 
international requirements by adopting a two-tiered classification 
system. The majority of commenters state they believe the requirements 
will ease the movement of these materials in transit and reduce 
confusion, thereby increasing safety. Therefore, in this final rule, we 
are adopting the classification system as proposed in the NPRM.
    The requirements adopted in this final rule establish a two-tiered 
classification system for Division 6.2 materials--Category A and 
Category B. Category A infectious substances pose a higher degree of 
risk than Category B infectious substances. Category A material is an 
infectious substance transported in a form capable of causing permanent 
disability or life-threatening or fatal disease to otherwise healthy 
humans or animals when exposure to it occurs. An exposure occurs when 
an infectious substance is released outside of its protective 
packaging, resulting in physical contact with humans or animals. 
Category A infectious substances are assigned to existing 
identification numbers UN 2814 (for substances causing disease in 
humans or in both humans and animals) or UN 2900 (for substances 
causing disease in animals only), and are to be packaged and described 
according to applicable HMR provisions for these materials. The 
following are examples of Category A infectious substances, as 
designated by scientists at WHO and the U.S. Department of Health and 
Human Services (HHS). Please note this list is not all inclusive and is 
provided only as guidance. Note also that many of the entries on the 
list include the modifier ``(cultures only).'' For these materials, 
only cultures of the listed infectious substances are considered 
Category A infectious substances. Other forms of these infectious 
substances may be transported as Category B infectious substances.

------------------------------------------------------------------------
  Category A infectious substances  UN
      No. and proper shipping name                Micro-organism
------------------------------------------------------------------------
UN 2814--Infectious substances           Bacillus anthracis (cultures
 affecting humans and animals.            only).
                                         Brucella abortus (cultures
                                          only).
                                         Brucella melitensis (cultures
                                          only).
                                         Brucella suis (cultures only).
                                         Burkholderia mallei--
                                          Pseudomonas mallei--Glanders
                                          (cultures only).
                                         Burkholderia pseudomallei--
                                          Pseudomonas pseudomallei
                                          (cultures only).
                                         Chlamydia psittaci--avian
                                          strains (cultures only).
                                         Clostridium botulinum (cultures
                                          only).
                                         Coccidioides immitis (cultures
                                          only).
                                         Coxiella burnetti (cultures
                                          only).
                                         Crimean-Congo hemorrhagic fever
                                          virus.
                                         Dengue virus (cultures only).
                                         Eastern equine encephalitis
                                          virus (cultures only).
                                         Escherichia coli, verotoxigenic
                                          (cultures only).
                                         Ebola virus.
                                         Flexal virus.
                                         Francisella tularensis
                                          (cultures only).
                                         Guanarito virus.
                                         Hantaan virus.
                                         Hantaviruses causing
                                          hemorrhagic fever with renal
                                          syndrome.
                                         Hendra virus.
                                         Herpes B virus (cultures only).
                                         Human immunodeficiency virus
                                          (cultures only).
                                         Highly pathogenic avian
                                          influenza virus (cultures
                                          only).
                                         Japanese Encephalitis virus
                                          (cultures only).
                                         Junin virus.
                                         Kyasanur forest disease virus.
                                         Lassa virus.
                                         Machupo virus.
                                         Marburg virus.
                                         Monkeypox virus.
                                         Mycobacterium tuberculosis
                                          (cultures only).
                                         Nipah virus.

[[Page 32246]]

 
                                         Omsk hemorrhagic fever virus.
                                         Poliovirus (cultures only).
                                         Rabies and other lyssaviruses
                                          (cultures only).
                                         Rickettsia prowazekii (cultures
                                          only).
                                         Rickettsia rickettsia (cultures
                                          only).
                                         Rift Valley fever virus
                                          (cultures only).
                                         Russian spring-summer
                                          encephalitis virus (cultures
                                          only).
                                         Sabia virus.
                                         Shigella dysenteriae type I
                                          (cultures only).
                                         Tick-borne encephalitis virus
                                          (cultures only).
                                         Variola virus.
                                         Venezuelan equine encephalitis
                                          virus (cultures only).
                                         Vesicular stomatitis virus
                                          (cultures only).
                                         West Nile virus (cultures
                                          only).
                                         Yellow fever virus (cultures
                                          only).
                                         Yersinia pestis (cultures
                                          only).
UN 2900--Infectious substances           African swine fever virus
 affecting animals only.                  (cultures only).
                                         Avian paramyxovirus Type 1--
                                          Velogenic Newcastle disease
                                          virus (cultures only).
                                         Classical swine fever virus
                                          (cultures only).
                                         Foot and mouth disease virus
                                          (cultures only).
                                         Lumpy skin disease virus
                                          (cultures only).
                                         Mycoplasma mycoides--Contagious
                                          bovine pleuropneumonia
                                          (cultures only).
                                         Peste des petits ruminants
                                          virus (cultures only).
                                         Rinderpest virus (cultures
                                          only).
                                         Sheep-pox virus (cultures
                                          only).
                                         Goatpox virus (cultures only).
                                         Swine vesicular disease virus
                                          (cultures only).
------------------------------------------------------------------------

    A Category B infectious substance is one that does not meet the 
criteria for inclusion in Category A. A Category B infectious substance 
does not cause permanent disability or life-threatening or fatal 
disease to humans or animals when exposure to it occurs. Under the 
provisions of the 13th Edition of the UN Recommendations, adopted in 
December 2002, a Category B infectious substance is described as 
``Diagnostic Specimen'' or ``Clinical Specimen'' and assigned to UN 
3373.
    Currently, the HMR define a ``diagnostic specimen'' to mean any 
human or animal material being transported for diagnostic or 
investigative purposes. In accordance with current Sec.  173.199, 
diagnostic specimens are excepted from most HMR requirements except for 
minimal packaging and hazard communication. Historically, the HMR have 
permitted a proper shipping name, such as ``Diagnostic specimen,'' 
listed in the Sec.  172.101 Table to be used to describe a non-
hazardous material on a shipping paper and package marking provided the 
UN or NA identification number is not included. See Sec. Sec.  
172.202(e) and 172.303(b)(3). However, adoption of the proper shipping 
name ``Diagnostic specimen'' in both the international standards and 
the HMR resulted in some confusion on the part of both shippers and 
carriers who are accustomed to using these terms to refer to human or 
animal samples that have a low probability of containing an infectious 
pathogen. In addition, using these terms to describe shipments of 
Category B infectious substances is not completely accurate--there are 
many shipments of Category B infectious substances that may not be 
diagnostic specimens as that term is usually defined.
    The UN Sub-Committee of Experts on the Transport of Dangerous Goods 
discussed the proper shipping name issue during its July 2004 meeting 
and agreed to adopt a different proper shipping name for Category B 
infectious substances--``Biological substance, Category B.'' The UN 
adopted this proper shipping name for the 14th Revised Edition of the 
UN Recommendations, which is effective January 1, 2007; ICAO adopted 
the new proper shipping name through an addendum to the 2005-2006 ICAO 
Technical Instructions. The addendum permits use of the new proper 
shipping name as an alternative to ``Diagnostic Specimen'' or 
``Clinical Specimen'' until January 1, 2007, at which time the new name 
must be used. Consistent with the revised international standards, the 
May 9, 2005 NPRM proposed to adopt the proper shipping name 
``Biological substance, Category B'' in the HMR. No commenters opposed 
this proposal, and it is adopted in this final rule. Thus, a Category B 
infectious substance must be described as ``Biological substance, 
Category B'' and assigned to UN 3373.

B. Packaging Requirements for Category B Infectious Substances

    Currently, the HMR require Risk Group 2 and 3 infectious substances 
(most of which will be classed as Category B infectious substances 
under this final rule) to be transported in triple packagings certified 
to comply with the performance standards in Sec.  178.609, including a 
drop test from a height of 9 m (30 ft), a water spray test, and a 
puncture test. In the NPRM, we proposed to permit Category B infectious 
substances to be transported in non-specification triple packagings 
capable of passing a drop test only at a height of 1.2 meters (3.9 
feet). Commenters support this proposal. We are adopting this 
requirement in this final rule.
    The NPRM proposed to require these packagings to be capable of 
passing the drop test set forth in Sec.  178.603, which prescribes 
tests for all non-bulk packaging designs. As suggested by one commenter 
(TEN-E), in this final rule, we are replacing the reference to Sec.  
178.603 with Sec.  178.609. The drop test established in Sec.  178.609 
applies specifically to infectious substance packagings; this testing 
configuration more appropriately addresses the integrity issues for 
infectious substance packages.

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    The NPRM proposed to require the outer packaging of the triple pack 
authorized for the transportation of Category B infectious substances 
to be rigid; the proposal is consistent with requirements adopted for 
air shipments of Category B infectious substances in the ICAO Technical 
Instructions. One commenter (ACLA) suggests this requirement is 
unnecessary because a packaging capable of passing a 1.2 meter drop 
test has sufficiently demonstrated it can withstand normal 
transportation conditions. The commenter states this requirement would 
impose unnecessary costs on clinical laboratories with no safety 
benefit. We disagree. As indicated above, Category B packagings must be 
capable of passing a drop test, but need not be capable of passing a 
puncture or other performance test. A requirement for a rigid outer 
packaging will help to ensure that the entire package can withstand 
punctures and other conditions that may be encountered during 
transportation and particularly at package sorting facilities. In 
addition, a rigid outer packaging will help to ensure that package 
markings are intact and legible in the event the package is damaged 
during transportation. We therefore find the safety benefits of a 
requirement for a rigid outer packaging outweigh the minimal additional 
cost of such packaging. However, we do agree a rigid packaging 
conforming to HMR requirements may be placed inside an envelope or 
other non-rigid overpack conforming with Sec.  173.25 of the HMR.
    The commenter (ACLA) also asks us to provide guidance concerning 
what constitutes a rigid outer packaging. An outer packaging is defined 
under Sec.  171.8 as the outermost enclosure of a composite or 
combination packaging together with any absorbent materials, 
cushioning, and any other components necessary to contain and protect 
inner receptacles or inner packagings. A rigid packaging is 
sufficiently stiff and unyielding so as to retain its original shape 
and dimensions at all times and under all conditions of transportation.
    Current HMR requirements require infectious substances packed with 
materials intended to stabilize or prevent degradation of the sample to 
be transported in accordance with provisions applicable to the hazard 
class of the stabilizing material used. In the NPRM, we proposed to 
relax this requirement to except Packing Group II or III materials used 
to stabilize or prevent degradation of infectious materials up to a 
limit of 30 mL (1 ounce) or 30 g (1 ounce) in each inner packaging from 
HMR requirements. A commenter (ACLA) suggests we permit each inner 
packaging to contain up to 250 mL (25% of the total permitted volume of 
liquid material per primary receptacle) of Packing Group II or III 
material. We disagree. For shipments by air, the maximum quantity 
contained in each inner receptacle of the package may not exceed 1 L; 
the maximum quantity contained in each outer package may not exceed 4 
L. Thus, the revision proposed by ACLA would permit as much as 1 L of a 
stabilizing material or preservative to be transported in a single 
package with no additional packaging or hazard communication 
requirements. Particularly for shipments transported by aircraft, we 
believe quantities of Packing Group II or III materials in excess of 30 
mL pose a sufficient hazard as to require at least minimal regulation. 
The limit of 30 mL per inner receptacle is consistent with the small 
quantity exception in Sec.  173.4, which excepts small quantities (up 
to 30 mL or 30 g per inner receptacle) of certain hazard materials from 
all HMR requirements provided minimal packaging requirements are met. 
Moreover, the triple packaging design for infectious substances is 
similar to the minimal packaging authorized for small quantities of 
hazardous materials under Sec.  173.4. Thus, we are adopting the 
limitation on the quantity of preservative permitted in each inner 
packaging as proposed in the NPRM. If a shipper elects to use a larger 
quantity of preservative, the shipment must conform to HMR requirements 
applicable to the specific material and quantity being shipped.
    Two commenters (Escott, JBM) asked us to clarify that the 
requirement for a pressure differential test for packagings used to 
transport Category B infectious substances applies only to 
transportation by aircraft. As discussed in the NPRM, this provision in 
existing Sec.  173.199(b)(4) is not changed in this final rule. Either 
the primary or secondary receptacle for a liquid Category B infectious 
substance must be capable of withstanding, without leakage, an internal 
pressure producing a pressure differential of 95 kPa (0.95 bar, 14 psi) 
when offered or intended for transport by aircraft.

C. Emergency Contact Information for Category B Infectious Substances

    Currently, the HMR require packages of Risk Group 2 and 3 
infectious substances (most of which will be classed as Category B 
infectious substances under this final rule) to be accompanied by 
shipping papers that include a telephone number that is monitored at 
all times the hazardous material is in transportation; the telephone 
number must be the number of a person who is knowledgeable about the 
hazardous material being shipped and has comprehensive emergency 
response and incident mitigation information for that material (see 
Sec.  172.604). Because Category B infectious substances are excepted 
from shipping paper requirements, in the May 9, 2005 NPRM, we proposed 
to require the proper shipping name; UN number; and name, address, and 
telephone number of a person knowledgeable about the material to be 
provided on a written document, such as an air waybill, accompanying a 
Category B infectious substance shipment or on the package itself. Two 
commenters object to the requirement for a contact telephone number. 
One commenter (Escott) suggests the expense of monitoring the number 
while the shipment is in transit would impose a significant cost burden 
on clinical laboratories, medical facilities, and other infectious 
substance shippers. A second commenter (JBM) suggests the address on 
the packaging should be sufficient for contacting the responsible party 
in the event of an incident.
    This provision to add the emergency contact name and telephone 
number for Category B infectious substances is intended to harmonize 
hazard communication for these materials with requirements in the 2005-
2006 ICAO Technical Instructions. The number need not be monitored at 
all times the hazardous material is in transportation, as would be 
required under Sec.  172.604 of the HMR. However, we do intend it to be 
monitored during a company's administrative office hours. Thus, we 
expect the burden of complying with this requirement will be minimal. 
Consistent with revisions adopted by ICAO in November 2005, in this 
final rule, we are not requiring an address as part of the contact 
information. Emergency contact information shown on a shipping document 
or on the package must include the name and telephone number of a 
person knowledgeable about the shipment.
    We disagree that the number should not be required. Having access 
to a telephone number will enable transport workers and emergency 
responders to contact a person knowledgeable about the shipment within 
a reasonable period of time and, thus, will facilitate the retrieval of 
information concerning the material and its potential hazards.

D. Exceptions for Certain Shipments

    The HMR currently except certain shipments of infectious substances 
from all regulatory requirements when the shipments are transported by 
a private

[[Page 32248]]

or contract carrier in a motor vehicle used exclusively to transport 
these materials. In the NPRM, we propose to expand this exception to 
Category B infectious substances transported for research, diagnosis, 
investigational activities, or disease treatment or prevention. One 
commenter (Escott) recommends the HMR include minimal packaging 
requirements for such shipments, such as non-specification triple 
packagings with absorbent material, and minimal marking and labeling 
requirements. Escott states, ``When I worked in a hospital, I received 
specimens that were transported by a courier and were leaking * * *'' 
We do not agree Category B shipments transported by private or contract 
carriers should be regulated under the HMR. We do not have reports of 
safety problems involving courier shipments of infectious materials 
under the exception currently provided in the HMR. Courier shipments 
typically are packaged in primary receptacles, sealed in leak-proof 
plastic bags, and placed in a leak proof outer container that includes 
cushioning material. 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 handling 
potentially infectious materials. Requiring additional packaging and 
hazard communication requirements would add to the cost of shipping 
such materials without improving safety. Therefore, we are adopting the 
exception as proposed in the NPRM.
    In the NPRM, we indicated the HMR do not apply to a human or animal 
sample transported for routine testing when the testing is not related 
to the diagnosis of an infectious disease and when there is no reason 
to suspect the sample is infectious. Routine screening tests include: 
(1) Blood or urine tests a doctor may order as part of a routine 
medical examination to monitor cholesterol levels, blood glucose 
levels, hormone levels, or prostate specific antibodies (PSA); (2) 
blood or urine tests to monitor liver or kidney functions in 
individuals who are not known to have an infectious disease and who are 
following a particular drug therapy regime; (3) blood or urine tests 
conducted for insurance or employment purposes and/or intended to 
determine the presence of alcohol or drugs; (4) DNA tests; and (5) 
pregnancy tests. Routine tests for diagnoses for other than the 
presence of pathogens include biopsies to detect cancer and antibody 
titre testing. This exception proposed in the NPRM is consistent with 
exceptions adopted in the UN Recommendations for substances unlikely to 
cause disease in humans or animals, and substances for which there is a 
low probability an infectious pathogen is present.
    Three of the four commenters addressing this issue (ACLA, Alcoa, 
ABC), support the exception from the HMR for transporting specimens 
from apparently healthy individuals and animals for routine diagnostic 
testing for other than an infectious disease. These commenters state 
many years of experience shows the probability of such samples being 
infectious is low, and, therefore, their transportation is unlikely to 
compromise safety. These commenters also state permitting the 
transportation of samples from apparently healthy individuals for 
routine testing will facilitate the processing of such samples and 
initiation of appropriate patient treatment. One commenter (JBM) 
opposes the exception. The commenter suggests samples from apparently 
healthy individuals may contain pathogens and recommends minimal 
packaging standards to guard against the release of the sample during 
transportation.
    We agree with the commenters who suggest that samples from 
apparently healthy individuals and animals being transported for 
routine testing unrelated to the diagnosis of an infectious disease are 
not likely to be infectious and, thus, pose a minimal safety risk. 
Patient specimens excepted from regulation under the HMR are those from 
persons believed by professional judgment to have a minimal likelihood 
of harboring an infectious agent. These specimens typically are blood, 
serum, urine, stool, biopsies, hair, finger or toe nails, semen, or 
other similar samples from a body. According to health care specialists 
and scientists at WHO and the U.S. Department of Health and Human 
Services, the risk of infection during transportation from samples 
taken from apparently healthy patients and animals and transported for 
routine testing is extremely small. Therefore, we are adopting the 
exception from HMR requirements for such samples as proposed in the 
NPRM.
    Shippers and carriers should be aware ICAO has adopted minimal 
standards applicable to the transportation of human or animal specimens 
for which there is minimal likelihood that pathogens are present. Such 
specimens are not subject to ICAO requirements when they are 
transported in a packaging designed to prevent any leakage and marked 
with the words ``Exempt human specimen'' or ``Exempt animal specimen,'' 
as applicable. This is a mandatory ICAO requirement; however, we are 
not adopting it in this final rule. Such samples are not transported in 
a quantity or form that poses an unreasonable risk to health and 
safety. Thus, for purposes of the HMR, such specimens are not 
considered hazardous materials and are not subject to any requirements. 
Note that use of the ``Exempt human specimen'' or ``Exempt animal 
specimen'' marks by a shipper indicates that the relevant packages do 
not contain a hazardous material. Therefore, packages bearing these 
marks may be accepted by air carriers making a business decision to not 
accept hazardous materials. Conversely, packages bearing the Proper 
Shipping Names ``Infectious Substance, affecting humans'' or 
``Infectious Substance, affecting animals'' or ``Biological Substance, 
Category B'' must be rejected by air carriers making a business 
decision to not accept hazardous materials.

E. Notification to Pilot-in-Command

    Generally, a notification to the pilot-in-command (NOPIC) is 
required for shipments of hazardous materials subject to the HMR or 
ICAO Technical Instructions. The NOPIC includes the proper shipping 
name, hazard class, and identification number of the hazardous 
material; the total number of packages; the net quantity or gross 
weight for each package; the location of the packages on the aircraft; 
any additional information required by the regulations; and 
confirmation that no damaged or leaking packages have been loaded on 
the aircraft (see Sec.  175.33 of the HMR and Chapter 4, paragraph 
4.1.1, and Chapter 7, paragraph 7.4.1 of the ICAO Technical 
Instructions). The NOPIC provides the pilot-in-command with information 
to make critical decisions and take necessary safety precautions in the 
event of an emergency on board the aircraft.?>
    In the preamble to the NPRM, we indicated, consistent with the ICAO 
Technical Instructions, we were not proposing to require a NOPIC for 
air shipments of Category B infectious substances. We noted that ICAO 
narrowly decided against such a requirement for the 2005-2006 Edition 
of the ICAO Technical Instruction. ICAO members opposed to the 
requirement cited the low risk in transportation associated with 
Category B infectious substances, new ICAO requirements for hazard 
communication for Category B shipments, and the possibility that 
increased regulation would result in fewer carriers electing to 
transport Category B shipments. Members supporting the NOPIC

[[Page 32249]]

requirement cited the benefit of information being available to the 
pilot and emergency responders in the event of an emergency or an 
accident. We invited commenters to address this issue, and whether or 
not the HMR should require a NOPIC for shipments of Category B 
infectious substances.
    Of the three commenters who address this issue, two (ATA, ACLA) 
support the ICAO decision to not require a NOPIC for Category B 
infectious substances. These commenters note Category B infectious 
substances pose a reduced risk in transportation because they do not 
cause permanent disability or life-threatening or fatal disease to 
humans or animals. These commenters agree the hazard communication 
requirements in the ICAO Technical Instruction provide sufficient 
information for package handlers and emergency responders to make 
necessary safety decisions in the event of an emergency. The commenters 
also state the NOPIC provision would increase administrative and 
training costs and could result in the refusal by some carriers to 
transport these materials. The ultimate impact of a NOPIC provision in 
the HMR, according to these commenters, could be to impede or delay 
transportation of Category B infectious substances.
    One commenter (ALPA) supports a requirement for a NOPIC for 
shipments of Category B infectious substances. This commenter suggests 
a NOPIC is necessary to enable transport workers to make informed 
judgments concerning the segregation and loading of packages and 
enhances the ability of the pilot in command to make potentially life-
saving decisions concerning the occupants of his or her aircraft and to 
advise emergency personnel.
    As indicated above, Category B infectious materials pose a reduced 
risk in transportation because they do not cause life-threatening or 
fatal disease in otherwise healthy humans or animals. The hazard 
communication requirements adopted in this final rule are adequate to 
assure transport workers exercise care in handling packages of Category 
B materials and protect themselves if they discover a damaged or 
leaking package. We agree with commenters who suggest the impact of 
requiring a NOPIC for shipments of Category B infectious materials 
would be to impede or delay transportation of these shipments; such 
delays could adversely affect patient treatment and public health. 
Therefore, we are not adopting a requirement for a NOPIC for shipments 
of Category B infectious substances in this final rule.

F. Regulated Medical Waste

    The HMR currently define regulated medical waste (RMW) to mean a 
waste or reusable material known to contain or suspected to contain 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. In the 
NPRM, we proposed to revise this definition to mean a waste or reusable 
material known to contain or suspected to contain a Category B 
infectious substance. In accordance with the definition proposed in the 
NPRM, RMW containing a Category A infectious substance must be classed 
as Division 6.2, described as an infectious substance affecting humans 
or affecting animals only, as appropriate, assigned to UN 2814 or UN 
2900, and transported in accordance with all applicable requirements. 
Medical waste containing a Category A infectious substance may not be 
transported under the shipping name ``Regulated medical waste, 
n.o.s.,'' UN 3291. Medical waste containing a Category A infectious 
substance must be described as ``Infectious substances, affecting 
humans'' or ``Infectious substances, affecting animals,'' assigned to 
UN 2814 or UN 2900, and packaged in a UN specification packaging 
conforming to the requirements of Sec.  173.196 of the HMR. Infectious 
medical waste containing a Category A infectious substance is not 
excepted from regulation under 173.134(c) of the HMR when transported 
by private or contract carriers.
    One commenter (Stericycle) expresses concern about the NPRM's 
treatment of RMW containing a Category A infectious substance, 
suggesting the proposals could be confusing for facilities generating 
RMW and the carriers transporting them. The commenter asks us to 
consider permitting RMW containing a Category A infectious substance to 
be transported as ``Regulated medical waste, n.o.s.,'' UN 3291, noting 
that about one-half of the materials listed in the preamble to the NPRM 
as Category A infectious materials are currently assigned to Risk Group 
2 or 3 materials permitted to be transported as RMW under UN 3291.
    The requirements adopted in this final rule for the transportation 
of RMW containing a Category A infectious substance are the same as the 
current HMR requirements for the transportation of RMW containing a 
Risk Group 4 infectious substance. A Category A infectious substance is 
one transported in a form capable of causing permanent disability or 
life-threatening or fatal disease to an otherwise healthy human or 
animal when exposure to it occurs. Certain Category B infectious 
substances in culture form pose a significant risk in transportation 
and were added to the Category A list under the regulations of the UN 
Recommendations, ICAO Technical Instructions, and the IMDG Code. We 
have adopted this provision as proposed in the NPRM to harmonize with 
these requirements.
    As Stericycle notes, a number of the infectious agents on the list 
of Category A infectious substances are currently considered Risk Group 
2 or 3 materials. However, they are included on the Category A list 
only as cultures--that is, when the pathogen is intentionally 
propagated. Most cultured infectious substances are not transported for 
disposal, but are destroyed or rendered non-infectious onsite. In all 
other forms, these materials are considered Category B infectious 
substances and may be transported as ``Regulated medical waste, 
n.o.s.,'' UN 3291. Requiring infectious medical waste containing a 
Category A infectious substance to be transported as an infectious 
substance, UN 2814 or 2900, appropriately addresses the risks posed by 
these materials. Therefore, we are adopting the requirements applicable 
to the transportation of RMW as proposed in the NPRM. RMW containing a 
Category A infectious substance should be handled and managed at 
medical facilities in the same manner as RMW containing a Risk Group 4 
infectious substance is currently handled.

G. Sharps Containers

    As currently required under the HMR, sharps containers generally 
must comply with Sec.  173.197, which requires sharps to be in a UN 
specification packaging that is puncture resistant for sharps and 
sharps with residual fluid, as demonstrated by conformance with the 
design and test requirements in subpart M of part 178 at the Packing 
Group II performance level. The performance tests must be conducted 
with the packaging assembled as if for transportation, including with 
the closure secured as it would be for transportation. A sharps 
container that conforms to these requirements need not be placed in an 
outer packaging for transport. Under Sec.  178.2(c), the packaging 
manufacturer must provide each person to whom the packaging is sold or 
transferred with a notification in writing specifying the types and 
dimensions of the closures, including gaskets and any other components

[[Page 32250]]

needed to assure the packaging is capable of passing the required 
tests. This notification must also include any procedures to be 
followed, including closures for inner packaging and receptacles, to 
enable a shipper to effectively assemble and close the package to 
prevent leakage during transportation.
    A sharps container placed inside a bulk packaging, such as a UN 
specification Large Packaging or a non-specification bulk outer 
packaging or wheeled cart, must be puncture resistant. A sharps 
container that is 20 gallons or less in volume need not be a UN 
specification packaging if it is to be placed in a bulk outer 
packaging. A sharps container that is larger than 20 gallons in volume 
that is placed inside a bulk packaging must be capable of passing the 
performance tests in subpart M of part 178 at the Packing Group II 
performance level. A sharps container that will be placed in a bulk 
outer packaging for transportation may be reused only if it is 
specifically cleared or approved by FDA as a medical device for reuse 
and must have a capacity of between 2 and 40 gallons.
    The HMR include an exception from certain requirements for 
regulated medical waste (RMW), including sharps, transported by a 
private or contract carriers (see Sec.  173.134(c)). Under this 
exception, RMW, including sharps, may be transported in a rigid, non-
bulk packaging that conforms to the general packaging requirements of 
Sec. Sec.  173.24 and 173.24a and packaging requirements specified in 
OSHA standards at 29 CFR 1910.1030. The packaging requirements in 
Sec. Sec.  173.24 and 173.24a address general packaging issues such as 
packaging integrity, filling limits, and closures. Specifically with 
regard to leakproofness, Sec.  173.24(f) requires closures to be 
leakproof and secured against loosening. The OSHA standards at 29 CFR 
1910.1030 require sharps containers to be puncture resistant and 
leakproof (see 1910.1030(d)(4)(iii)(A)(1)).
    The NPRM proposed to clarify that sharps containers must be 
securely closed to prevent leaks or punctures based on our enforcement 
experience indicating insecure closures permit sharps to protrude from 
sharps containers during transportation. In the last two years, we have 
initiated five civil enforcement cases related to inadequate closures 
on sharps containers; there have been a number of other instances where 
an inspector identified problems with the closures, but did not 
initiate a civil enforcement action. One commenter (Gillian) states 
``single use sharps container lids * * * will come off inside a 
transport container * * *. Some 40% of these containers have the lid 
dislodged in transport spilling their contents into the red bag.'' The 
commenters who address this issue (Gillian, NSWMA/MWI, Stericycle) are 
concerned the proposed requirement is not sufficiently precise and does 
not include sufficient guidance on the procedures to be followed to 
ensure compliance by container manufacturers or shippers. To address 
commenters' concerns that the proposal concerning closures was not 
sufficiently precise, in this final rule, we are modifying the 
provisions to specify a sharps packaging must be securely closed to 
prevent punctures or leakage during transportation in accordance with 
the instructions provided by the packaging manufacturer.
    In the NPRM, we discussed Food and Drug Administration (FDA) 
requirements for sharps containers regulated as medical devices subject 
to pre-market review by FDA and asked commenters to address whether the 
HMR should permit FDA-cleared or -approved sharps containers to be used 
for the transportation of sharps and, if so, under what circumstances. 
The two commenters who addressed this issue had mixed views. One 
commenter (NSWMA) opposes the use of FDA-cleared sharps containers for 
transportation unless the container conforms in all respects to the HMR 
requirements in Sec. Sec.  173.197 and 173.134. The commenter notes 
FDA's review process is intended to address whether the device is 
reasonable safe and effective for its intended use in hospital, 
laboratory, or healthcare facility settings, not in transportation. A 
second commenter (Stericycle), however, asserts the FDA requirements 
address the integrity of the material used to make sharps containers 
and assure containers meet puncture-resistance criteria and are leak-
proof on the sides and bottom. This commenter recommends the HMR 
require all sharps to be transported in FDA-cleared containers.
    As we stated in the preamble to the NPRM, sharps containers cleared 
or approved by FDA may not meet current HMR requirements in Sec. Sec.  
173.134 and 173.197. For example, the FDA review process is designed to 
determine, among other things, whether sharps containers are leak 
resistant on the sides and bottom and whether closures are leak 
resistant. This is a lesser standard than the leak-proofness standard 
established in the HMR. For this reason, we disagree with the commenter 
who recommends the HMR require all sharps to be transported in FDA-
cleared containers. FDA-cleared sharps containers may be used to 
transport sharps provided the container conforms to applicable HMR 
requirements or the sharps container is placed inside a leak-proof 
outer packaging.
    Two commenters express concern about the current requirement in the 
HMR for sharps containers to be leak-proof. One commenter (Stericycle) 
notes certain sharps containers are designed specifically to allow for 
venting to assure steam penetration during autoclaving and suggests the 
leak-proofness standard negatively impacts the effectiveness of 
autoclaving. This commenter suggests there are safe and effective 
alternatives to a leak-proofness standard for transportation, such as 
requiring containers to be positioned in an upright position in a 
transport vehicle or requiring absorbent material in sharps containers. 
Another commenter (Daniels) is concerned the HMR do not include a leak-
proofness test standard. This commenter asserts sharps containers 
should be required to be leak-proof without secondary containment and 
proposes a leak-proofness test for incorporation into the HMR.
    We did not propose in the NPRM to modify the current requirements 
for sharps containers to be leakproof. Thus, the comments concerning 
these requirements are beyond the scope of this rulemaking. However, we 
may consider revising the requirements for sharps containers in a 
future rulemaking.

H. Miscellaneous Comments

    The HMR currently require air carriers to inspect all hazardous 
materials packages prior to transportation to ensure that the package 
conforms to HMR requirements and has no holes, leakage, or other 
indication that its integrity has been compromised (see Sec.  175.30 
(b)). Except for radioactive materials packages, there are no current 
requirements for inspecting packages for signs of leakage when they are 
unloaded from an aircraft. In the NPRM, we proposed to require for air 
transportation each package and overpack containing a Division 6.2 
material to be inspected for signs of leakage. If evidence of leakage 
is discovered, the cargo compartment in which the package or overpack 
was transported must be disinfected. This proposal is consistent with 
the inspection requirements for air shipments in the ICAO Technical 
Instructions. One commenter (ALPA) suggests this requirement should 
also apply to packages of Division 6.2 materials transported on pallets 
or in

[[Page 32251]]

unit load devices. We agree, and are adopting this change in this final 
rule.
    One commenter (JBM) asks us to clarify the difference between the 
exception for medical equipment in Sec.  173.134(b)(12) and the 
requirements for the transportation of used health care products in 
Sec.  173.199. In accordance with Sec.  173.134(b)(12), medical 
equipment, including equipment intended for use, cleaning, or 
refurbishment is excepted from the HMR when it is transported in 
accordance with standards established by the Occupational Safety and 
Health Administration (OSHA) at 29 CFR 1910.1030. The regulations in 
Sec.  173.199 are intended for the transportation of used health care 
products that do not conform to the OSHA standards.
    A commenter (Schulte) suggests we move the requirements for the 
transportation of used health care products from Sec.  173.199 and 
relocate them to Sec.  173.134. The commenter states placing the 
requirements for used health care products in the same section as 
requirements for the transportation of Category B infectious substances 
suggests the risk from the transportation of used health care products 
is the same as for Category B infectious substances. We agree; in this 
final rule, we are relocating the requirements for used health care 
products currently in Sec.  173.199(d) to Sec.  173.134(b)(12)(ii).

III. Section-by-Section Review

    This section-by-section review summarizes the changes adopted in 
this final rule.

Part 171

    Section 171.8. In Sec.  171.8, we are removing the definition for 
Risk Group.

Part 172

    Section 172.101. In the Hazardous Materials Table, we are making 
several revisions. Most importantly, we are removing the current entry 
for ``Diagnostic Specimens'' for consistency with the 14th Revised 
Edition of the UN Recommendations. We are adding an entry for 
``Biological substance, Category B.'' This entry will apply to 
shipments of Category B infectious substances, which must be classed as 
Division 6.2, described as a ``Biological substances, Category B,'' and 
assigned to UN 3373.
    In addition, we are revising the entries for ``Infectious 
substances, affecting animals'' and ``Infectious substances, affecting 
humans'' to delete Special Provision A81 (see discussion below).
    Section 172.102. We are removing Special Provision A81, which 
permits the quantity limits currently specified in the HMT for air 
shipments to be exceeded for shipments of body fluids packaged in 
accordance with Sec.  173.196. This special provision is no longer 
necessary because paragraphs (b)(5) and (c)(6) of Sec.  173.199 include 
quantity limits for air transportation applicable to shipments of 
Category B infectious substances.
    Section 172.200. Consistent with requirements in the ICAO Technical 
Instructions, in Sec.  172.200(b)(4) we are clarifying the shipping 
paper requirements do not apply to Category B infectious substances 
prepared in accordance with Sec.  173.199 of the HMR. This is 
consistent with the requirements adopted for the UN Recommendations 
under Packing Instruction 650 and Special Provision 319, which except 
Category B infectious substances from shipping paper requirements.
    Section 172.203. Under this final rule, unknown samples of 
infectious substances shipped for analysis and diagnosis may be 
transported in accordance with requirements for Category B infectious 
substances, because historically, materials meeting this definition 
have been transported in a similar manner with no adverse safety impact 
or increased risk to transport workers or the general public. For 
situations where the identity of the agent or pathogen is not known, 
but sufficient information is available to strongly suspect a Category 
A infectious substance, this final rule requires an indication on 
shipping papers that the sample contains a Category A infectious 
material. Suspected Category A infectious substances must be shipped in 
accordance with all applicable hazard communication and packaging 
requirements for Category A infectious substances. The determination as 
to whether to ship an unknown sample as a Category A or Category B 
infectious substance should be made by appropriate medical or public 
health officials based on known medical conditions and history of the 
source patient or animal, endemic local conditions, and symptoms of the 
source patient or animal. Thus, in paragraph (k) of Sec.  172.203, we 
are authorizing a shipping paper accompanying a shipment of a suspected 
Category A infectious substance to include the words ``suspected 
Category A infectious substance'' in parentheses as an alternative to a 
technical name to describe the pathogen(s) it contains when the 
infectious substance is not known. Thus, the shipping description for a 
suspected Category A infectious substance affecting humans would read, 
``Infectious substances, affecting humans (suspected Category A 
infectious substance), 6.2, UN 2814''. For known Category A pathogens, 
the technical name of the pathogen must be indicated.
    Section 172.301. Consistent with the UN Recommendations, paragraph 
(b) of Sec.  172.301 states technical names need not be marked on the 
outer packaging of Division 6.2 materials.
    Section 172.800. We are requiring persons who offer for 
transportation or transport select agents and toxins regulated by USDA 
under 9 CFR part 121 to develop and implement security plans in 
accordance with requirements in Subpart I of part 172 of the HMR.

Part 173

    Section 173.6. The current exception for materials of trade (MOTS) 
prohibits Risk Group 4 infectious substances from being transported as 
MOTS. We are modifying Sec.  173.6(a)(4) to prohibit Category A 
infectious substances and suspected Category A infectious substances, 
rather than Risk Group 4 infectious substances, from being transported 
as materials of trade (MOTS). This amendment is consistent with the 
definition and classification criteria for infectious substances 
adopted for the UN Recommendations. In addition, we are modifying the 
packaging requirements for MOTS shipments of Division 6.2 materials. 
For consistency with international standards, we are limiting the 
amount of material each packaging may contain rather than the 
capacities of the packagings used. Finally, we are adding a requirement 
for sharps containers to be securely closed to prevent leaks or 
punctures. As indicated above, we are concerned the closures currently 
being used for sharps containers may not be adequate to assure no 
contents will be released during transportation.
    Section 173.24a. We are modifying paragraph (c)(2) in Sec.  173.24a 
to prohibit a package containing inner packagings of Division 6.2 
materials from containing any other hazardous materials except for dry 
ice, liquid nitrogen, or small amounts of other hazardous material in 
Packing Groups II or III used to preserve or stabilize the infectious 
substance. Hazardous materials most commonly used to preserve or 
stabilize an infectious substance include methanol, isopropyl alcohol, 
boric acid, formaldehyde, formalin, and sodium borate. This provision 
is consistent with a provision adopted for the 2005-2006 edition of the 
ICAO Technical Instructions and by the UN Transport of Dangerous Goods 
Subcommittee for the 14th Revised Edition of the UN Recommendations.

[[Page 32252]]

The packaging requirements for Division 6.2 materials, which include 
triple packaging and absorbent material, are comparable to the 
packaging permitted for transporting hazardous materials in accordance 
with the small quantity exceptions in Sec.  173.4 and should minimize 
the risk of a release in transportation. Therefore, when a hazardous 
preservative, such as a Class 3 or Class 8 material in Packing Groups 
II or III, is included in the inner packaging with the material, the 
preservative is not be subject to HMR requirements provided the amount 
in the inner packaging does not exceed 30 mL for a liquid or 30 g for a 
solid. The maximum quantity in an outer package, including a hazardous 
material used to preserve or stabilize a sample, may not exceed 4 L or 
4 kg. Note this exception applies only to materials in Packing Groups 
II or III; PG I materials are not authorized. Note also, for amounts in 
excess of 30 mL or 30 g per inner packaging, hazardous preservative 
materials are regulated under the HMR and must be transported in 
accordance with requirements applicable to their specific 
classification and characteristics.
    Section 173.134. We are making a number of revisions to Sec.  
173.134 for consistency with definitions and provisions adopted for the 
UN Recommendations, as follows:
    (1) We are modifying the definition for a Division 6.2 material. 
The definition adopted in this final rule replaces the Risk Group 
ranking system with the two-tiered Category A and Category B system 
adopted by the UN Recommendations. The definition includes a 
requirement for a Division 6.2 material to be assigned an appropriate 
identification number: UN 2814 for Category A infectious substances 
affecting humans or both humans and animals; UN 2900 for Category A 
infectious substances affecting animals only; UN3373 for Category B 
infectious substances; and UN 3291 for Regulated medical waste.
    (2) We are modifying the definition for ``biological product'' to 
replace the Risk Group ranking references with references to Category A 
and Category B infectious substances.
    (3) We are adopting a definition for ``cultures'' consistent with 
the definition for ``cultures'' adopted in the UN for the 14th Revised 
Edition of the UN Recommendations. Cultures are the result of a process 
by which pathogens are intentionally propagated by use of ideal 
conditions, including temperature, environment, and nutrient-based 
propagation media. The definition adopted in this final rule refers to 
cultures prepared for the intentional generation of pathogens and does 
not include patient specimens intended for diagnostic or clinical 
purposes.
    (4) We are adopting a new definition for ``patient specimen.'' As 
defined in this final rule, ``patient specimen'' means human or animal 
materials collected directly from humans or animals and transported for 
research, diagnosis, investigational activities, or disease treatment 
or prevention. Examples include excreta, secreta, blood and its 
components, tissue and tissue swabs, and body parts.
    (5) We are modifying the definition for ``regulated medical waste'' 
to incorporate Category A and Category B infectious substances. RMW 
containing a Category A infectious substance must be classed as 
Division 6.2, described as an infectious substance, and assigned to UN 
2814 or UN 2900, as appropriate. RMW containing Category B infectious 
substances is assigned to UN 3291.
    (6) We are modifying the listed exceptions in paragraph (b) of 
Sec.  173.134 for consistency with the UN Recommendations. Most of the 
exceptions are unchanged. However, we are adding an exception for a 
material with a low probability of containing an infectious substance 
or where the concentration of the infectious substance is at a level 
naturally occurring in the environment that will not cause disease when 
exposure occurs. Examples include foodstuffs and certain environmental 
samples. The new provision referring to environmental samples would 
replace the exception for these materials in current Sec.  
173.134(b)(13). In addition, we are adding an exception for dried blood 
spots and for specimens used to detect fecal occult blood. These are 
specimens collected from healthy patients for routine testing and 
screening (e.g., DNA analysis, forensic studies, immunologic studies, 
cancer screening, and nutritional evaluations of infants, children, and 
adults). The specimen is placed on paper, allowed to saturate the 
paper, and then dried completely. The specimens pose an extremely 
minimal risk of infection, and may be rendered unusable if placed in 
packaging that retains moisture or heat to the sample. More than 100 
million specimens have been safely transported by routine mail over the 
last 30 years. Health professionals recommend these materials should be 
transported in a double-envelope system forming a double-layer 
protective barrier (i.e., inner and outer-sealed high quality, air-
permeable paper envelope) or an attached heavy paper fold-over flap 
container placed into a secondary high-quality paper envelope.
    In addition, in this final rule, we are excepting from regulation 
under the HMR a human or animal sample transported for routine testing 
not related to diagnosis of an infectious disease and for which there 
is no reason to suspect the sample is infectious. Routine screening 
tests include: (1) Blood or urine tests a doctor may order as part of a 
routine medical examination to monitor cholesterol levels, blood 
glucose levels, hormone levels, or prostate specific antibodies (PSA); 
(2) blood or urine tests to monitor liver or kidney functions for the 
millions of people who are not known to have an infectious disease and 
who are following a particular drug therapy regime; (3) blood or urine 
tests conducted for insurance or employment purposes and/or intended to 
determine the presence of alcohol or drugs; (4) DNA tests; and (5) 
pregnancy tests. Tests for diagnoses other than for the presence of 
pathogens include biopsies to detect cancer and antibody titre testing. 
This exception is consistent with exceptions adopted in the UN 
Recommendations for substances unlikely to cause disease in humans or 
animals and substances for which there is a low probability infectious 
substances are present.
    (7) We are revising the exceptions in paragraph (c)(1) applicable 
to the transportation of regulated medical waste. We are adding a 
requirement for sharps containers shipped in accordance with this 
exception to be securely closed to prevent leaks or punctures. In 
addition, we are modifying paragraph (c)(2) to revise the current 
reference to Risk Group 2 or 3 infectious substances to Category B 
infectious substances.
    (8) We are relocating requirements for transporting used health 
care products from Sec.  173.199(d) to Sec.  173.134(b)(12)(ii).
    Section 173.196. We are modifying the Division 6.2 material 
packaging requirements in Sec.  173.196 for consistency with the UN 
Recommendations. Generally, the revisions are editorial and do not 
change current packaging requirements. We are adding a requirement for 
outer packagings to be rigid. Note the packaging requirements in Sec.  
173.196 apply to shipments of Category A infectious substances only. 
The language describing the minimum size of the outer packaging is 
revised to clarify no external dimension of the packaging, i.e., no 
measurement on any outer surface of the packaging, shall be less than 
100 mm (3.9 inches). Category B infectious substances are to be

[[Page 32253]]

transported in accordance with the provisions in Sec.  173.199.
    Section 173.197. We are modifying the RMW packaging requirements in 
Sec.  173.197 to incorporate Category A and Category B infectious 
substances. The revisions do not substantively change the current 
packaging requirements for non-bulk or bulk shipments of RMW.
    We are revising Sec.  173.197(b) for clarification by correcting in 
the first sentence, ``except as otherwise provided in Sec.  173.134 of 
this subpart'' to read ``except as authorized by Sec.  173.134(c).'' In 
addition, in current paragraph (b) non-bulk RMW packaging is currently 
described as a DOT specification packaging meeting the requirements of 
Part 178 at the PG II performance level. We are revising the phrase 
``DOT specification'' to read ``UN standard'' because non-bulk PG II 
refers to packagings in Part 178, Subpart L, conforming to a UN 
standard.
    In Sec.  173.197(d)(2)(iii), the reference to the drop test 
requirement prescribed in Sec.  178.603 for non-bulk packagings is not 
correct. It should read ``Each Cart must be capable of meeting the 
requirements of Sec.  178.810 (drop test) at the Packing Group II 
performance level.'' This section contains the drop test requirements 
for an intermediate bulk packaging.
    In Sec.  173.197(e)(3), in the introductory paragraph, we are 
revising the wording ``the performance tests in Sec.  178.601'' to read 
``the performance tests in part 178, subpart M''. There are no 
performance tests in Sec.  178.601. This revision makes Sec.  
173.197(e)(3) consistent with Sec.  173.197(b). Finally, we are adding 
a requirement for sharps containers to be securely closed to prevent 
leaks or punctures in conformance with instructions provided by the 
packaging manufacturer. We are concerned the closures currently being 
used for sharps containers may not be adequate to ensure no contents 
will be released during transportation.
    Section 173.199. We are modifying this section for consistency with 
the UN Recommendations and ICAO Technical Instructions. Under this 
final rule, the provisions of Sec.  173.199 will apply to shipments of 
Category B infectious substances. The packaging requirements are 
substantially the same as the current requirements for shipping 
diagnostic specimens, except we are requiring the outer packaging to be 
rigid. The completed packaging must be capable of passing the drop 
tests in Sec. Sec.  178.609(d) and (h) at a height of 1.2 meters (3.9 
feet). We are adopting pass/fail criteria for the drop test--there must 
be no leakage from the primary receptacle, and the primary receptacle 
must remain protected by absorbent material, when required, in the 
secondary packaging. In addition, we are requiring the use of absorbent 
materials for solids that may become liquid during transportation.
    Consistent with amendments adopted for the UN Recommendations, we 
are removing the current capacity limitations for shipment of Category 
B infectious substances, except for Category B infectious substances 
transported by air. For air shipments of these materials, we are 
modifying the current limitations on capacity consistent with the 
amendments adopted in the 2005-2006 ICAO Technical Instructions. For 
liquids, we are increasing the amount of material permitted in each 
inner packaging from 500 mL (16.9 ounces) to 1 L (34 ounces); the 
limitation on the total amount of material permitted in the outer 
packaging remains 4 L (1 gallon). For solids, we are deleting the 
limitation on the amount of material permitted in each inner packaging; 
again, the limitation on the total amount of material permitted in the 
outer packaging remains 4 kg (8.8 pounds). We are also requiring at 
least one surface of the outer packaging to have a minimum dimension of 
100 mm by 100 mm (3.9 inches).
    Consistent with provisions proposed to be adopted for the 14th 
Edition of the UN Recommendations, we are requiring a package 
containing a Category B infectious substance and prepared in accordance 
with Sec.  173.199 to be marked with the identification number ``UN 
3373'' in a square-on-point configuration and with the proper shipping 
name ``Biological substances, Category B.'' Each side of the square-on-
point mark must be at least 50 mm in length, and the proper shipping 
name ``Biological substances, Category B'' must be in letters at least 
6 mm high. The proper shipping name, UN number, and the name, address, 
and telephone number of a person knowledgeable about the shipment must 
be included on a written document, such as an air waybill or bill of 
lading, or on the outer packaging. The knowledgeable person should be 
available during the company's administrative office hours to provide 
information about how to respond to emergencies or releases involving 
the package and appropriate first aid. Finally, we are permitting small 
amounts of hazardous materials in Packing Groups II or III, not to 
exceed 30 mL (1 ounce) or 30 g (1 ounce) in each inner packaging, to be 
used to preserve or stabilize the material. Such preservatives are not 
subject to HMR requirements.
    Category B infectious substances prepared in accordance with Sec.  
173.199 are excepted from all other HMR requirements except for 
incident reporting and the requirements in Part 175 of the HMR 
prohibiting a hazardous material subject to the HMR requirements from 
being transported in the cabin of a passenger aircraft or the flight 
deck of any aircraft.
    The requirements in Sec.  173.199(d) for used health care products 
are relocated to Sec.  173.134(b)(12)(ii).

Part 175

    Section 175.630. We are adding a new paragraph (c) to this section 
to require air carriers to inspect packages containing Division 6.2 
materials for leakage when they are unloaded. If evidence of leakage is 
found, the cargo compartment must be disinfected. In response to 
comments, we are modifying the proposal in this final rule to require 
air carriers to inspect unit load devices as well as individual 
packages and packages in overpacks.

IV. Rulemaking Analysis and Notices

A. Statutory/Legal Authority for This Rulemaking

    This final rule is published under the following statutory 
authorities:
    1. 49 U.S.C. 5103(b) authorizes the Secretary of Transportation to 
prescribe regulations for the safe transportation, including security, 
of hazardous material in intrastate, interstate, and foreign commerce. 
This final rule adopts regulations to enhance the safe and secure 
transportation of infectious substances in intrastate, interstate, and 
foreign commerce. To this end, as discussed in detail earlier in this 
preamble, the final rule revises current HMR requirements applicable to 
infectious substances for classification, packaging, and hazard 
communication and for offerors and transporters of certain infectious 
substances to develop and implement security plans.
    2. 49 U.S.C. 5120(b) authorizes the Secretary of Transportation to 
ensure that, to the extent practicable, regulations governing the 
transportation of hazardous materials in commerce are consistent with 
standards adopted by international authorities. This final rule adopts 
regulations applicable to the transportation of infectious substances 
in commerce consistent with international standards applicable to such 
transportation. To this end, as discussed in detail earlier in this 
preamble, the final rule harmonizes current HMR requirements for 
infectious substances with the standards adopted for the transportation 
of

[[Page 32254]]

infectious substances in the UN Recommendations, the 2005-2006 ICAO 
Technical Instructions, and Amendment 32 to the IMDG Code. The 
continually increasing amount of hazardous materials transported in 
international commerce warrants the harmonization of domestic and 
international requirements to the greatest extent possible. 
Harmonization serves to facilitate international transportation; at the 
same time, harmonization ensures the safety of people, property, and 
the environment by reducing the potential for confusion and 
misunderstanding that could result if shippers and transporters were 
required to comply with two or more conflicting sets of regulatory 
requirements. While the intent of this rulemaking is to align the HMR 
with international standards, we review and consider each amendment on 
its own merit based on its overall impact on transportation safety and 
the economic implications associated with its adoption into the HMR. 
Our goal is to harmonize without sacrificing the current HMR level of 
safety and security and without imposing undue burdens on the regulated 
public. As discussed in detail earlier in this preamble, there are 
several instances where we elected not to propose adoption of a 
specific provision of the UN Recommendations or the ICAO Technical 
Instructions. Further, we are maintaining a number of current 
exceptions for domestic transportation to minimize the compliance 
burden on the regulated community.

B. Executive Order 12866 and DOT Regulatory Policies and Procedures

    This final rule is not a significant regulatory action under 
section 3(f) of Executive Order 12866 and, therefore, was not reviewed 
by the Office of Management and Budget. This final rule is not 
considered significant under the Regulatory Policies and Procedures of 
the Department of Transportation (44 FR 11034). This final rule will 
reduce transportation costs for shipments of certain infectious 
substances. We estimate annual cost savings of $3.85 billion. 
Additional benefits resulting from the adoption of the amendments in 
this final rule include enhanced transportation safety, security, and 
efficiency resulting from consistent domestic and international 
transportation requirements. The final rule will result in new costs of 
compliance related to the development and implementation of 
transportation security plans for persons who ship USDA-regulated 
select agents and toxins. A regulatory evaluation for this final rule 
is in the public docket for this rulemaking.
    This final rule relaxes requirements for transporting Category B 
infectious substances. Currently, many of these infectious substances 
must be shipped in appropriately marked and labeled UN specification 
packagings and accompanied by shipping papers and emergency response 
information; these infectious substances are also subject to incident 
reporting requirements. Under this final rule, Category B infectious 
substances may be shipped in non-specification packagings, marked with 
the appropriate UN number. However, they are excepted from labeling and 
shipping documentation requirements. Category B infectious substances 
are also excepted from incident reporting requirements, except for 
shipments by aircraft.
    We estimate that shippers of most infectious substances will 
realize an average cost savings of $77 per shipment. There are no 
published data on the number of infectious substances shipments 
transported each year. Industry estimates suggest about 160 million 
patient samples are shipped outside of a local area each year (ground 
transportation of infectious substances is excepted from most HMR 
requirements). A shipment may contain from one to 20 test tubes or 
primary containers, with an average of about 3 primary containers per 
package. Thus, the number of shipments transported annually by air may 
total 53 million. Under this final rule, most of these shipments will 
realize a cost savings of $77, for a total annual cost savings of $3.85 
billion (50 million shipments x $77/shipment).
    This final rule will also result in significant non-monetized 
benefits. The final rule harmonizes the requirements in the HMR for 
transporting infectious substances with international standards in the 
UN Recommendations, the ICAO Technical Instructions, and the 
International Maritime Dangerous Goods Code. Harmonization of 
requirements in the HMR with international standards will allow us to 
avoid inconsistencies between the regulations, thereby facilitating 
rapid and efficient transportation of infectious substances across 
national or international borders, which is critical to public health. 
Moreover, harmonized regulations reduce the potential for 
misunderstanding and confusion and, thus, enhance safety.
    Estimating the security benefits of this final rule is difficult. 
In the end, when security measures are evaluated, an element of 
judgment is required to determine whether the costs of the measures are 
justified by the benefits that will accrue. We believe the relatively 
small costs imposed on individual companies to comply with the security 
plan requirements are more than offset by the benefits if there is a 
finite chance that these measures might avert a successful attack. Most 
entities handling USDA-regulated select agents and toxins likely have 
already implemented security measures similar to those required under 
the HMR. The security requirements are not onerous. They are prudent, 
common sense security measures in line with public expectations about 
the need to take action to protect hazardous materials shipments from 
terrorist acts.

C. 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 (49 U.S.C. 5125(b)) 
preempting State, local, and Indian tribe requirements on certain 
covered subjects. Covered subjects are:
    (1) The designation, description, and classification of hazardous 
materials;
    (2) The packing, repacking, handling, labeling, marking, and 
placarding of hazardous materials;
    (3) The preparation, execution, and use of shipping documents 
related to hazardous materials and requirements related to the number, 
contents, and placement of those documents;
    (4) The written notification, recording, and reporting of the 
unintentional release in transportation of hazardous material; or
    (5) The design, manufacture, fabrication, marking, maintenance, 
recondition, repair, or testing of a packaging or container 
represented, marked, certified, or sold as qualified for use in 
transporting hazardous material.
    This final rule addresses covered subject items (1), (2), (3), (4), 
and (5) described above and preempts State, local, and Indian tribe 
requirements not meeting the ``substantively the same'' standard. This 
final rule is necessary to harmonize domestic regulations for the

[[Page 32255]]

transportation of infectious substances with international standards.
    Federal hazardous materials transportation law provides at Sec.  
5125(b)(2) that, if DOT issues a regulation concerning any of the 
covered subjects, DOT must determine and publish in the Federal 
Register the effective date of Federal preemption. The effective date 
may not be earlier than the 90th day following the date of issuance of 
the final rule and not later than two years after the date of issuance. 
The effective date of Federal preemption of this final rule will be 90 
days from publication in the Federal Register.

D. 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''). Because this proposed 
rule does not have tribal implications and does not impose direct 
compliance costs, the funding and consultation requirements of 
Executive Order 13175 do not apply.

E. Regulatory Flexibility Act, Executive Order 13272, and DOT 
Procedures and Policies

    The Regulatory Flexibility Act (5 U.S.C. 601-611) requires each 
agency to analyze proposed regulations and assess their impact on small 
businesses and other small entities to determine whether the proposed 
rule is expected to have a significant impact on a substantial number 
of small entities. A regulatory evaluation for this NPRM, which 
includes a detailed small business impact analysis, is in the public 
docket for this rulemaking.
    Businesses likely to be affected by the provisions of this final 
rule are the more than 441,000 establishments comprising North American 
Industrial Classification System Major Groups 32, 48, 54, and 62, 
including offices and clinics of doctors of medicine, dentists, doctors 
of osteopathy, chiropractors, optometrists, podiatrists, and health 
practitioners; nursing and personal care facilities; hospitals; medical 
and dental laboratories; and patients. For purposes of the small 
business impact analysis, the definition of ``small business'' has the 
same meaning as under the Small Business Act. The majority of the 
businesses likely to be affected by the provisions of this final rule 
are small businesses (from 68% of general medical and surgical 
hospitals to nearly 100% of doctors' offices and research 
laboratories).
    For the most part, affected businesses will incur no increased 
costs to comply with the provisions of this final rule; indeed, the 
provisions of this final rule will reduce overall transportation costs 
for most of these entities. Manufacturers and distributors of packages 
intended for the transportation of infectious substances will incur 
costs associated with retaining copies of filling and closure 
instructions for such packages; we estimate the cost per company will 
be about $750/year. In addition, air carriers will incur increased 
costs associated with new cargo inspection requirements; we estimate 
these costs would amount to $1.34 per package of infectious substances 
transported. Finally, the final rule imposes new costs on the regulated 
industry for shipments of select agents and toxins regulated by USDA; 
we estimate these costs would amount to $1,125 per company to develop a 
security plan and a subsequent annual cost of $225 per entity to update 
and maintain the security plan. The annual costs attributed to the 
provisions of 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.
    Benefits resulting from the adoption of the amendments in this 
final rule include reduced transportation costs for shipments of 
certain infectious substances and enhanced transportation safety, 
security, and efficiency resulting from consistent domestic and 
international transportation requirements. For example, companies 
shipping infectious substances can expect to experience an average cost 
savings of $77 per shipment as packaging costs decrease from between 
$88.30-$143.78 to between $29.85-$48.07 as a result of new packaging 
requirements for Category B infectious substances and $1.90 per 
shipment as a result of revised hazard communication requirements for 
Category B infectious substances. In addition, the final rule will 
result in enhanced security for the transportation of select agents. 
Finally, the final rule removes inconsistencies between the HMR and 
international transportation standards applicable to the transportation 
of infectious substances, thereby facilitating efficient transportation 
across national and international borders and reducing the potential 
for misunderstanding and confusion in applying the regulatory 
requirements.
    Based on the above analysis, I certify that while this final rule 
will affect a significant number of small entities it will not have a 
significant economic impact on a substantial number of small entities.
    This final rule has been developed in accordance with Executive 
Order 13272 (``Proper Consideration of Small Entities in Agency 
Rulemaking'') and DOT's procedures and policies to promote compliance 
with the Regulatory Flexibility Act to ensure potential impacts of 
draft rules on small entities are properly considered.

F. Unfunded Mandates Reform Act of 1995

    This final rule does not impose unfunded mandates under the 
Unfunded Mandates Reform Act of 1995. It will not result in costs of 
$120.7 million or more, in the aggregate, to any of the following: 
State, local, or Native American tribal governments, or the private 
sector.

G. Paperwork Reduction Act

    This final rule does not impose any new information collection 
requirements.

H. 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 number contained in the heading 
of this document may be used to cross-reference this action with the 
Unified Agenda.

I. Environmental Assessment

    The National Environmental Policy Act of 1969 (NEPA), as amended 
(42 U.S.C. 4321-4347), requires Federal agencies to consider the 
consequences of major federal actions and prepare a detailed statement 
on actions significantly affecting the quality of the human 
environment. There are no significant environmental impacts associated 
with this final rule. We are adopting changes to certain HMR 
requirements for the transportation of infectious substances in order 
to promote safer transportation practices, facilitate international 
commerce, and make these requirements compatible with new international 
standards regarding the transportation of infectious substances.

J. Privacy Act

    Any comments received into any of our dockets may be searched 
electronically by the name of the individual submitting the comments 
(or signing the comment, if submitted on behalf of an association, 
business, labor union, etc.). You may review DOT's complete Privacy Act 
Statement in the Federal Register published on April 11,

[[Page 32256]]

2000 (Volume 65, Number 70; Pages 19477-78) or you may visit http://dms.dot.gov.

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, 
Incorporation by reference, Labeling, Markings, Packaging and 
containers, Reporting and recordkeeping requirements.

49 CFR Part 173

    Hazardous materials transportation, Incorporation by reference, 
Packaging and containers, Radioactive materials, Reporting and 
recordkeeping requirements, Uranium.

49 CFR Part 175

    Air carriers, Hazardous materials transportation, Incorporation by 
reference, Radioactive materials, Reporting and recordkeeping 
requirements.


0
In consideration of the foregoing, we are amending 49 CFR parts 171, 
172, 173, and 175 as follows:

PART 171--GENERAL INFORMATION, REGULATIONS, AND DEFINITION

0
1. The authority citation for part 171 continues to read as follows:

    Authority: 49 U.S.C. 5101-5127, 44701; 49 CFR 1.45 and 1.53; 
Pub. L. 101-410 section 4 (28 U.S.C. 2461 note); Pub. L. 104-134 
section 31001.


Sec.  171.8  [Amended]

0
2. In Sec.  171.8, the definition for ``Risk Group'' is removed.

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

0
3. The authority citation for part 172 continues to read as follows:

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

0
4. In Sec.  172.101, in the Hazardous Materials Table, the following 
changes are made:
0
a. The entry ``Diagnostic specimen'' is removed.
0
b. The entry ``Biological substance, Category B'' is added in 
appropriate alphabetic order.
0
c. The entries ``Infectious substances, affecting animals only;'' 
``Infectious substances, affecting humans;'' and ``Regulated medical 
waste, n.o.s.'' are revised.
    The additions and revisions read as follows:


Sec.  172.101  Purpose and use of hazardous materials table.

* * * * *

[[Page 32257]]



 
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                       Hazardous                                                                                                 (8)  Packaging (Sec.   173.* * *)           (9)  Quantity limitations         (10)  Vessel stowage
                       materials        Hazard                                                                           ---------------------------------------------------------------------------------------------------------------
     Symbols       descriptions and    class or     Identification          PG            Label Codes         Special
                    proper shipping    Division        numbers                                              provisions      Exceptions       Non-bulk          Bulk          Passenger      Cargo air-       Location          Other
                         names                                                                                                                                            aircraft/ rail    craft only
(1)               (2)...............         (3)  (4)..............  (5)............  (6)...............  (7)...........  (8A)..........  (8B)..........  (8C)..........  (9A)..........  (9B)..........  (10A).........  (10B)
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 
                                                                                                              * * * * * * *
                  Biological                 6.2  UN3373...........  ...............  ..................  A82...........  134...........  199...........  None..........  4 L or 4 kg...  4 L or 4 kg...  A.............  40
                   substance,
                   Category B.
 
                                                                                                              * * * * * * *
G...............  Infectious                 6.2  UN2900...........  ...............  6.2...............  A82...........  134...........  196...........  None..........  50 mL or 50 g.  4 L or 4 kg...  B.............  40
                   substances,
                   affecting animals
                   only.
G...............  Infectious                 6.2  UN 2814..........  ...............  6.2...............  A82...........  134...........  196...........  None..........  50 mL or 50 g.  4 L or 4 kg...  B.............  40
                   substances,
                   affecting humans.
 
                                                                                                              * * * * * * *
G...............  Regulated medical          6.2  UN3291...........  II.............  6.2...............  A13...........  134...........  197...........  197...........  No limit......  No limit......  B.............  40
                   waste, n.o.s.
 
                                                                                                              * * * * * * *
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 32258]]

* * * * *


Sec.  172.102  [Amended]

0
5. In Sec.  172.102, in paragraph (c)(2), Special Provision A81 is 
removed.

0
6. In Sec.  172.200, paragraph (b)(4) is added to read as follows:


Sec.  172.200  Applicability.

* * * * *
    (b) * * *
    (4) Category B infectious substances prepared in accordance with 
Sec.  173.199.

0
7. In Sec.  172.203, in paragraph (k) introductory text a sentence is 
added after the last sentence to read as follows:


Sec.  172.203  Additional description requirements.

* * * * *
    (k) * * * A material classed as Division 6.2 and assigned 
identification number UN 2814 or 2900 because it is suspected to 
contain an unknown Category A infectious substance must have the words 
``suspected Category A infectious substance'' entered in parentheses in 
place of the technical name as part of the proper shipping description.
* * * * *

0
8. In Sec.  172.301, paragraph (b) is revised to read as follows.


Sec.  172.301  General marking requirements for non-bulk packagings.

* * * * *
    (b) Technical names. In addition to the marking required by 
paragraph (a) of this section, each non-bulk packaging containing a 
hazardous material subject to the provisions of Sec.  172.203(k) of 
this part, except for a Division 6.2 material, must be marked with the 
technical name in parentheses in association with the proper shipping 
name in accordance with the requirements and exceptions specified for 
display of technical descriptions on shipping papers in Sec.  
172.203(k) of this part. A technical name should not be marked on the 
outer package of a Division 6.2 material.
* * * * *

0
9. In Sec.  172.800, paragraph (b)(6) is revised to read as follows:


Sec.  172.800  Purpose and applicability.

* * * * *
    (b) * * *
    (6) A select agent or toxin regulated by the Centers for Disease 
Control and Prevention under 42 CFR part 73 or, by April 1, 2007, a 
select agent or toxin regulated by the United States Department of 
Agriculture under 9 CFR part 121; or
* * * * *

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

0
9. 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.


0
10. In Sec.  173.6, paragraph (a)(4) is revised to read as follows:


Sec.  173.6  Materials of trade exceptions.

    (a) * * *
    (4) A Division 6.2 material, other than a Category A infectious 
substance, contained in human or animal samples (including, but not 
limited to, secreta, excreta, blood and its components, tissue and 
tissue fluids, and body parts) being transported for research, 
diagnosis, investigational activities, or disease treatment or 
prevention, or is a biological product or regulated medical waste. The 
material must be contained in a combination packaging. For liquids, the 
inner packaging must be leakproof, and the outer packaging must contain 
sufficient absorbent material to absorb the entire contents of the 
inner packaging. For sharps, the inner packaging (sharps container) 
must be constructed of a rigid material resistant to punctures and 
securely closed to prevent leaks or punctures, and the outer packaging 
must be securely closed to prevent leaks or punctures. For solids, 
liquids, and sharps, the outer packaging must be a strong, tight 
packaging securely closed and secured against movement, including 
relative motion between packages, within the vehicle on which it is 
being transported.
    (i) For other than a regulated medical waste, the amount of 
Division 6.2 material in a combination packaging must conform to the 
following limitations:
    (A) One or more inner packagings, each of which may not contain 
more than 0.5 kg (1.1 lbs) or 0.5 L (17 ounces), and an outer packaging 
containing not more than 4 kg (8.8 lbs) or 4 L (1 gallon); or
    (B) A single inner packaging containing not more than 16 kg (35.2 
lbs) 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, each of which may not contain 
more than 4 kg (8.8 lbs) or 4 L (1 gallon), and an outer packaging 
containing not more than 16 kg (35.2 lbs) or 16 L (4.2 gallons).
* * * * *

0
11. In Sec.  173.24a, paragraph (c)(2) is revised to read as follows:


Sec.  173.24a  Additional general requirements for non-bulk packagings 
and packages.

* * * * *
    (c) * * *
    (2) A packaging containing inner packagings of Division 6.2 
materials may not contain other hazardous materials except--
    (i) Refrigerants, such as dry ice or liquid nitrogen, as authorized 
under the HMR;
    (ii) Anticoagulants used to stabilize blood or plasma; or
    (iii) Small quantities of Class 3, Class 8, Class 9, or other 
materials in Packing Groups II or III used to stabilize or prevent 
degradation of the sample, provided the quantity of such materials does 
not exceed 30 mL (1 ounce) or 30 g (1 ounce) in each inner packaging. 
The maximum quantity in an outer package, including a hazardous 
material used to preserve or stabilize a sample, may not exceed 4 L (1 
gallon) or 4 kg (8.8 pounds). Such preservatives are not subject to the 
requirements of this subchapter.
* * * * *

0
12. In Sec.  173.134, paragraph (a) introductory text and paragraphs 
(a)(1), through (a)(5) are revised; paragraph (a)(6) is removed; 
paragraphs (a)(7), (a)(8), and (a)(9) are redesignated paragraphs 
(a)(6), (a)(7), and (a)(8) respectively, and paragraphs (b), 
(c)(1)(ii), and (c)(2) are revised to read as follows:


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

    (a) Definitions and classification criteria. For the purposes of 
this subchapter, the following definitions and classification criteria 
apply to Division 6.2 materials.
    (1) Division 6.2 (Infectious substance) means a material known or 
reasonably expected to contain a pathogen. A pathogen is a 
microorganism (including bacteria, viruses, rickettsiae, parasites, 
fungi) or other agent, such as a proteinaceous infectious particle 
(prion), that can cause disease in humans or animals. An infectious 
substance must be assigned the identification number UN 2814, UN 2900, 
UN 3373, or UN 3291 as appropriate, and must be assigned to one of the 
following categories:
    (i) Category A: An infectious substance in a form capable of 
causing permanent disability or life-threatening or fatal disease in 
otherwise healthy humans or animals when exposure to it occurs. An 
exposure occurs when an infectious substance is released outside of its 
protective packaging, resulting in physical contact with humans or 
animals. A Category A infectious

[[Page 32259]]

substance must be assigned to identification number UN 2814 or UN 2900, 
as appropriate. Assignment to UN 2814 or UN 2900 must be based on the 
known medical history or symptoms of the source patient or animal, 
endemic local conditions, or professional judgment concerning the 
individual circumstances of the source human or animal.
    (ii) Category B: An infectious substance that is not in a form 
generally capable of causing permanent disability or life-threatening 
or fatal disease in otherwise healthy humans or animals when exposure 
to it occurs. This includes Category B infectious substances 
transported for diagnostic or investigational purposes. A Category B 
infectious substance must be described as ``Biological substance, 
Category B'' and assigned identification number UN 3373. This does not 
include regulated medical waste, which must be assigned identification 
number UN 3291.
    (2) Biological product means a virus, therapeutic serum, toxin, 
antitoxin, vaccine, blood, blood component or derivative, allergenic 
product, or analogous product, or arsphenamine or derivative of 
arsphenamine (or any other trivalent arsenic compound) applicable to 
the prevention, treatment, or cure of a disease or condition of human 
beings or animals. A biological product includes a material subject to 
regulation under 42 U.S.C. 262 or 21 U.S.C. 151-159. Unless otherwise 
excepted, a biological product known or reasonably expected to contain 
a pathogen that meets the definition of a Category A or B infectious 
substance must be assigned the identification number UN 2814, UN 2900, 
or UN 3373, as appropriate.
    (3) Culture means an infectious substance containing a pathogen 
that is intentionally propagated. Culture does not include a human or 
animal patient specimen as defined in paragraph (a)(4) of this section.
    (4) Patient specimen means human or animal material collected 
directly from humans or animals and transported for research, 
diagnosis, investigational activities, or disease treatment or 
prevention. Patient specimen includes excreta, secreta, blood and its 
components, tissue and tissue swabs, body parts, and specimens in 
transport media (e.g., transwabs, culture media, and blood culture 
bottles).
    (5) Regulated medical waste means a waste or reusable material 
derived from the medical treatment of an animal or human, which 
includes diagnosis and immunization, or from biomedical research, which 
includes the production and testing of biological products. Regulated 
medical waste is assigned to UN 3291, except for regulated medical 
waste containing a Category A infectious substance, which must be 
classed as a Division 6.2 material, described as an infectious 
substance, and assigned to UN 2814 or UN 2900, as appropriate.
* * * * *
    (b) Exceptions. The following are not subject to the requirements 
of this subchapter as Division 6.2 materials:
    (1) A material that does not contain an infectious substance or 
that is unlikely to cause disease in humans or animals.
    (2) Non-infectious biological materials from humans, animals, or 
plants. Examples include non-infectious cells, tissue cultures, blood 
or plasma from individuals not suspected of having an infectious 
disease, DNA, RNA or other non-infectious genetic elements.
    (3) A material containing micro-organisms that are non-pathogenic 
to humans or animals.
    (4) A material containing pathogens that have been neutralized or 
inactivated such that they no longer pose a health risk.
    (5) A material with a low probability of containing an infectious 
substance, or where the concentration of the infectious substance is at 
a level naturally occurring in the environment so it cannot cause 
disease when exposure to it occurs. Examples of these materials 
include: Foodstuffs; environmental samples, such as water or a sample 
of dust or mold; and substances that have been treated so that the 
pathogens have been neutralized or deactivated, such as a material 
treated by steam sterilization, chemical disinfection, or other 
appropriate method, so it no longer meets the definition of an 
infectious substance.
    (6) A biological product, including an experimental or 
investigational product or component of a product, subject to Federal 
approval, permit, review, or licensing requirements, such as those 
required by the Food and Drug Administration of the U.S. Department of 
Health and Human Services or the U.S. Department of Agriculture.
    (7) Blood collected for the purpose of blood transfusion or the 
preparation of blood products; blood products; plasma; plasma 
derivatives; blood components; 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 (42 U.S.C. 264-272) and/or the Food, Drug, and Cosmetic Act 
(21 U.S.C. 332 et seq.).
    (8) Blood, blood plasma, and blood components 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 as 
a Category A or Category B infectious substance in accordance with 
Sec.  173.196 or Sec.  173.199, as appropriate.
    (9) Dried blood spots or specimens for fecal occult blood detection 
placed on absorbent filter paper or other material.
    (10) A Division 6.2 material, other than a Category A infectious 
substance, contained in a patient sample being transported for 
research, diagnosis, investigational activities, or disease treatment 
or prevention, or a biological product, when such materials are 
transported by a private or contract carrier in a motor vehicle used 
exclusively to transport such materials. 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 the human or animal sample 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.
    (11) A human or animal sample (including, but not limited to, 
secreta, excreta, blood and its components, tissue and tissue fluids, 
and body parts) being transported for routine testing not related to 
the diagnosis of an infectious disease, such as for drug/alcohol 
testing, cholesterol testing, blood glucose level testing, prostate 
specific antibody testing, testing to monitor kidney or liver function, 
or pregnancy testing, or for tests for diagnosis of non-infectious 
diseases, such as cancer biopsies, and for which there is a low 
probability the sample is infectious.
    (12) Laundry and medical equipment and used health care products, 
as follows:
    (i) 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.

[[Page 32260]]

    (ii) Used health care products not conforming to the requirements 
in 29 CFR 1910.1030 and being returned to the manufacturer or the 
manufacturer's designee are excepted from the requirements of this 
subchapter when offered for transportation or transported in accordance 
with this paragraph (b)(12). For purposes of this paragraph, a health 
care product is used when it has been removed from its original 
packaging. Used health care products contaminated with or suspected of 
contamination with a Category A infectious substance may not be 
transported under the provisions of this paragraph.
    (A) 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).
    (B) 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).
    (C) 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.
    (D) Each person who offers or transports a used health care product 
under the provisions of this paragraph must know about the requirements 
of this paragraph.
    (13) 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.
    (14) Corpses, remains, and anatomical parts intended for interment, 
cremation, or medical research at a college, hospital, or laboratory.
    (15) 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 Category B 
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 Category A 
infectious substance or an infectious substance listed as a select 
agent in 42 CFR Part 73 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.
    (16) Agricultural products and food as defined in the Federal Food, 
Drug, and Cosmetics Act (21 U.S.C. 332 et seq.).
    (c) * * *
    (1) * * *
    (i) * * *
    (ii) The specific packaging requirements of Sec.  173.197, if 
packaged in a rigid non-bulk packaging conforming to the general 
packaging requirements of Sec. Sec.  173.24 and 173.24a and packaging 
requirements specified in 29 CFR 1910.1030, provided the material does 
not include a waste concentrated stock culture of an infectious 
substance. Sharps containers must be securely closed to prevent leaks 
or punctures.
    (2) A waste stock or culture of a Category B 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 Sec. Sec.  173.24 
and 173.24a and packaging requirements specified in 29 CFR 1910.1030 
and transported by a private or contract carrier in a vehicle used 
exclusively to transport 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. Sharps containers must be securely closed to 
prevent leaks or punctures.
* * * * *

0
13. In Sec.  173.196, the section title and paragraphs (a) introductory 
text, (a)(2), (a)(3), and (b) are revised, to read as follows.


Sec.  173.196  Category A infectious substances.

    (a) Category A infectious substances packaging. A packaging for a 
Division 6.2 material that is a Category A infectious substance 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. A 
packaging for a Category A infectious substance is a triple packaging 
consisting of the following components:
* * * * *
    (2) A watertight secondary packaging. If multiple fragile primary 
receptacles are placed in a single secondary packaging, they must be 
either wrapped individually or separated to prevent contact between 
them.
    (3) A rigid outer packaging of adequate strength for its capacity, 
mass and intended use. The outer packaging must measure not less than 
100 mm (3.9 inches) at its smallest overall external dimension.
* * * * *
    (b) Additional requirements for packaging Category A infectious 
substances. Category A infectious substances must be packaged according 
to the following requirements, depending on the physical state and 
other characteristics of the material.
    (1) Infectious substances shipped at ambient temperatures or 
higher. Primary receptacles must be made 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, paraffin sealing tape, or manufactured locking closure. 
Lyophilized substances may also be transported in primary receptacles 
that are flame-sealed with glass ampoules or rubber-stoppered glass 
vials fitted with metal seals.
    (2) Infectious substances shipped refrigerated or frozen (ice, pre-
frozen packs, dry ice). Ice, dry ice, or other refrigerant must be 
placed around 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

[[Page 32261]]

the ice or dry ice has dissipated. If ice is used, the outer packaging 
or overpack must be leakproof. If dry ice is used, the outer packaging 
or overpack 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 
transport by aircraft to which they could be subjected if refrigeration 
were lost.
    (3) Infectious substances shipped in liquid nitrogen. 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 transport by aircraft to which they could be subjected if 
refrigeration were lost. Refrigerated liquid nitrogen packagings must 
be metal vacuum insulated vessels or flasks 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.
* * * * *

0
14. In Sec.  173.197, paragraphs (a), (b), (d)(1)(iv), (d)(1)(vi), 
(d)(2)(iii), (d)(3)(vi), (e)(2) and (e)(3) introductory paragraph are 
revised to read as follows:


Sec.  173.197  Regulated medical waste.

    (a) General provisions. Non-bulk packagings, Large Packagings, and 
non-specification 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 provided in Sec.  173.134(c) of 
this subpart, non-bulk packagings for regulated medical waste must be 
UN standard packagings conforming to the requirements of Part 178 of 
this subchapter at the Packing Group II performance level. A non-bulk 
packaging used as a sharps container 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. 
Sharps containers must be securely closed to prevent leaks or punctures 
in conformance with the instructions provided by the packaging 
manufacturer in accordance with Sec.  178.2(c) of this subchapter.
* * * * *
    (d) * * *
    (1) * * *
    (iv) Untreated concentrated stock cultures of infectious substances 
containing Category A materials may not be transported in a Cart or 
BOP.
* * * * *
    (vi) Division 6.1 or Class 7 chemotherapeutic waste; untreated 
concentrated stock cultures of infectious substances containing 
Category B infectious substances; 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) * * *
    (iii) Each Cart must be capable of meeting the requirements of 
Sec.  178.810 (drop test) at the Packing Group II performance level.
* * * * *
    (3) * * *
    (vi) Division 6.1 or Class 7 chemotherapeutic waste, untreated 
concentrated stock cultures of infectious substances containing 
Category B infectious substances, unabsorbed liquids, and sharps may be 
transported in a BOP only if separated and secured as required in 
paragraph (d)(3)(v) of this section.
* * * * *
    (e) * * *
    (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 provisions of subpart B of this part. 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 must be securely closed to prevent 
leaks or punctures in conformance with instructions provided by the 
packaging manufacturer. Each sharps container exceeding 76 L (20 
gallons) in volume must be capable of passing the performance tests in 
Part 178, subpart M, of this subchapter at the Packing Group II 
performance level. A sharps container may be reused only if it conforms 
to the following criteria:
* * * * *
    15. In Sec.  173.199, the section title and paragraphs (a), (b) 
introductory text, (b)(1), (b)(2), (b)(5), and (c), (d), and (e) are 
revised, to read as follows:


Sec.  173.199  Category B infectious substances.

    (a) Category B infectious substances. Except as provided in this 
paragraph (a), Category B infectious substances are excepted from all 
other requirements of this subchapter when offered for transportation 
or transported in accordance with this section. Category B infectious 
substances offered for transportation or transported under the 
provisions of this section are subject to the incident reporting 
requirements in Sec. Sec.  171.15 and 171.16 of this subchapter and to 
the requirements in Sec.  175.85 of this subchapter concerning cargo 
location. Except as provided in paragraph (a)(9) of this section, a 
Category B infectious substance 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) A Category B infectious substance must be packaged in a triple 
packaging consisting of a primary receptacle, a secondary packaging, 
and a rigid 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 rigid 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 designed, constructed, 
maintained, filled, its contents limited, and closed so that under 
conditions normally encountered in transportation, including removal 
from a pallet or overpack for subsequent handling, there will be no 
release of hazardous material into the environment. Package 
effectiveness must not be substantially reduced for minimum and maximum 
temperatures, changes in humidity and pressure, and shocks, loadings 
and vibrations normally encountered during transportation. The 
packaging must be capable of successfully passing the drop tests in 
Sec. Sec.  178.609(d) and (h) of this subchapter at a drop height of at 
least 1.2 meters (3.9 feet). Following the drop

[[Page 32262]]

tests, there must be no leakage from the primary receptacle, which must 
remain protected by absorbent material, when required, in the secondary 
packaging. At least one surface of the outer packaging must have a 
minimum dimension of 100 mm by 100 mm (3.9 inches).
    (5) The following mark must be displayed on the outer packaging on 
a background of contrasting color. The width of the line must be at 
least 2 mm (0.08 inches) and the letters and numbers must be at least 6 
mm (0.24 inches) high. The size of the mark must be such that no side 
of the diamond is less than 50 mm (1.97 inches) in length. The proper 
shipping name ``Biological substances, Category B'' must be marked on 
the outer packaging adjacent to the diamond-shaped mark in letters that 
are at least 6 mm (0.24 inches) high.
[GRAPHIC] [TIFF OMITTED] TR02JN06.012

    (6) When packages are placed in an overpack, the package markings 
required by this section must be either clearly visible or reproduced 
on the outside of the overpack.
    (7) The name and telephone number of a person who is either 
knowledgeable about the material being shipped and has comprehensive 
emergency response and incident mitigation information for the 
material, or has immediate access to a person who possesses such 
knowledge and information, must be included on a written document (such 
as an air waybill or bill of lading) or on the outer packaging.
    (8) For transportation by aircraft, each package, overpack, pallet, 
or unit load device containing a Category B infectious substance must 
be inspected for leakage when it is unloaded from the aircraft. If 
evidence of leakage is found, the cargo compartment in which the 
package, overpack, pallet, or unit load device was transported must be 
disinfected. Disinfection may be by any means that will make the 
material released ineffective at transmitting disease.
    (9) A packaging containing inner packagings of Category B 
infectious substances may not contain other hazardous materials 
except--
    (i) Refrigerants, such as dry ice or liquid nitrogen, as authorized 
under paragraph (d) of this section;
    (ii) Anticoagulants used to stabilize blood or plasma; or
    (iii) Small quantities of Class 3, Class 8, Class 9, or other 
materials in Packing Groups II and III used to stabilize or prevent 
degradation of the sample, provided the quantity of such materials does 
not exceed 30 mL (1 ounce) or 30 g (1 ounce) in each inner packaging. 
Such preservatives are not subject to the requirements of this 
subchapter.
    (10) Clear instructions on filling and closing a packaging used to 
transport a Category B infectious substance must be provided by the 
packaging manufacturer and subsequent distributors to the consignor or 
person who prepares the package to enable the package to be correctly 
prepared for transport. A copy or electronic image of these 
instructions must be retained by the manufacturer and subsequent 
distributors for at least one year from the date of issuance, and made 
available for inspection by a Federal or state government 
representative upon request. Packagings must be filled and closed in 
accordance with the information provided by the packaging manufacturer 
or subsequent distributor.
    (b) Liquid Category B infectious substances. Liquid Category B 
infectious substances must be packaged in conformance with the 
following provisions:
    (1) The primary receptacle must be leakproof.
    (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 
either individually wrapped or separated to prevent contact between 
them. The absorbent material must be of sufficient quantity to absorb 
the entire contents of the primary receptacles and not compromise the 
integrity of the cushioning material or the outer packaging.
* * * * *
    (5) For shipments by aircraft, the maximum quantity contained in 
each primary receptacle, including any material used to stabilize or 
prevent degradation of the sample, may not exceed 1 L (34 ounces), and 
the maximum quantity contained in each outer packaging, including any 
material used to stabilize or prevent degradation of the samples, may 
not exceed 4 L (1 gallon). The outer packaging limitation does not 
include ice, dry ice, or liquid nitrogen when used to maintain the 
integrity of the material.
    (c) Solid Category B infectious substances. Solid Category B 
infectious substances 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.
    (2) If several fragile primary receptacles are placed in a single 
secondary packaging, they must be either individually wrapped or 
separated to prevent contact between them.
    (3) The secondary packaging must be siftproof.
    (4) If residual liquid may be present in the primary receptacle 
during transportation, then the material must be transported in 
accordance with requirements in paragraph (b) of this section. A solid 
material that may become liquid during transportation must be 
transported in accordance with paragraph (b) of this section.
    (5) Except for packages containing body parts, organs, or whole 
bodies, for shipment by aircraft, the outer packaging may not contain 
more than 4 kg (8.8 pounds), including any material used to stabilize 
or prevent degradation of the samples. The outer packaging limitation 
does not include ice, dry ice, or liquid nitrogen when used to maintain 
the integrity of the material.
    (d) Refrigerated or frozen specimens (ice, dry ice, and liquid 
nitrogen). In addition to complying with the requirements in this 
paragraph (d), dry ice and liquid nitrogen must be offered for 
transportation or transported in accordance with the applicable 
requirements of this subchapter.
    (1) Ice or dry ice must be placed outside the secondary packaging 
or in an overpack. 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 
or must have a leakproof liner. 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 
secondary packaging must maintain their integrity at the temperature of 
the refrigerant used, as well as the temperatures and pressures of 
transport by aircraft they could be subjected to if refrigeration were 
lost, and sufficient absorbent material must be provided to absorb all 
liquid, including melted ice.
    (2) The package is marked ``Carbon dioxide, solid'' or ``Dry ice'' 
and an

[[Page 32263]]

indication that the material being refrigerated is used for diagnostic 
treatment purposes (e.g., frozen medical specimens).
    (e) Training. Each person who offers or transports a Category B 
infectious substance under the provisions of this section must know 
about the requirements of this section.

PART 175--CARRIAGE BY AIRCRAFT

0
16. The authority citation for part 175 continues to read as follows:

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

0
17. In Sec.  175.630, the section heading is revised and paragraph (c) 
is added to read as follows:


Sec.  175.630  Special Requirements for Division 6.1 (poisonous) 
material and Division 6.2 (infectious substances) materials.

* * * * *
    (c) When unloaded from the aircraft, each package, overpack, 
pallet, or unit load device containing a Division 6.2 material must be 
inspected for signs of leakage. If evidence of leakage is found, the 
cargo compartment in which the package, overpack, or unit load device 
was transported must be disinfected. Disinfection may be by any means 
that will make the material released ineffective at transmitting 
disease.

    Issued in Washington, DC, on May 24, 2006, under the authority 
delegated in 49 CFR part 1.
Brigham A. McCown,
Acting Administrator.
[FR Doc. 06-4992 Filed 6-1-06; 8:45 am]
BILLING CODE 4910-60-P