2 June 2006
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[Federal Register: June 2, 2006 (Volume 71, Number 106)]
[Rules and Regulations]
[Page 32243-32263]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02jn06-15]
[[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
[[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 Eileen.Edmonson@dot.gov or infocntr@dot.gov.
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.
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Category A infectious substances UN
No. and proper shipping name Micro-organism
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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.
[[Page 32247]]
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