Hazardous Materials: Infectious Substances; Harmonization With the United Nations Recommendations, 32244-32263 [06-4992]
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Federal Register / Vol. 71, No. 106 / Friday, June 2, 2006 / Rules and Regulations
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
Pipeline and Hazardous
Materials Safety Administration
(PHMSA), Department of Transportation
(DOT).
ACTION: Final rule.
AGENCY:
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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
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(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 twotiered 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);
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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 riskgroup-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
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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
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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.
Micro-organism
UN 2814—Infectious substances affecting humans and animals ...........
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Category A infectious substances
UN No. and proper shipping name
Bacillus anthracis (cultures 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.
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Category A infectious substances
UN No. and proper shipping name
Micro-organism
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UN 2900—Infectious substances affecting animals 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 § 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
§ 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 §§ 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
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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).
African swine fever virus (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).
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
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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 § 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 § 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
§ 178.603 with § 178.609. The drop test
established in § 178.609 applies
specifically to infectious substance
packagings; this testing configuration
more appropriately addresses the
integrity issues for infectious substance
packages.
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The NPRM proposed to require the
outer packaging of the triple pack
authorized for the transportation of
Category B infectious substances to be
rigid; the proposal is consistent with
requirements adopted for air shipments
of Category B infectious substances in
the ICAO Technical Instructions. One
commenter (ACLA) suggests this
requirement is unnecessary because a
packaging capable of passing a 1.2 meter
drop test has sufficiently demonstrated
it can withstand normal transportation
conditions. The commenter states this
requirement would impose unnecessary
costs on clinical laboratories with no
safety benefit. We disagree. As indicated
above, Category B packagings must be
capable of passing a drop test, but need
not be capable of passing a puncture or
other performance test. A requirement
for a rigid outer packaging will help to
ensure that the entire package can
withstand punctures and other
conditions that may be encountered
during transportation and particularly at
package sorting facilities. In addition, a
rigid outer packaging will help to ensure
that package markings are intact and
legible in the event the package is
damaged during transportation. We
therefore find the safety benefits of a
requirement for a rigid outer packaging
outweigh the minimal additional cost of
such packaging. However, we do agree
a rigid packaging conforming to HMR
requirements may be placed inside an
envelope or other non-rigid overpack
conforming with § 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 § 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
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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 § 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
§ 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
§ 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
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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
§ 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 § 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
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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
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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
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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 pilotin-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 § 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
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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 lifesaving 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.
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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
§ 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
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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 § 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 § 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
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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 nonspecification 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 § 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 §§ 173.24
and 173.24a and packaging
requirements specified in OSHA
standards at 29 CFR 1910.1030. The
packaging requirements in §§ 173.24
and 173.24a address general packaging
issues such as packaging integrity,
filling limits, and closures. Specifically
with regard to leakproofness, § 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 * * *
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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 FDAcleared sharps containers for
transportation unless the container
conforms in all respects to the HMR
requirements in §§ 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 §§ 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.
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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 leakproof. One commenter (Stericycle) notes
certain sharps containers are designed
specifically to allow for venting to
assure steam penetration during
autoclaving and suggests the leakproofness 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 leakproofness 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 § 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
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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
§ 173.134(b)(12) and the requirements
for the transportation of used health
care products in § 173.199. In
accordance with § 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 § 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 § 173.199 and relocate
them to § 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
§ 173.199(d) to § 173.134(b)(12)(ii).
III. Section-by-Section Review
This section-by-section review
summarizes the changes adopted in this
final rule.
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Part 171
Section 171.8. In § 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
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the quantity limits currently specified in
the HMT for air shipments to be
exceeded for shipments of body fluids
packaged in accordance with § 173.196.
This special provision is no longer
necessary because paragraphs (b)(5) and
(c)(6) of § 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 § 172.200(b)(4) we are
clarifying the shipping paper
requirements do not apply to Category
B infectious substances prepared in
accordance with § 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 § 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
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32251
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
§ 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 § 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 § 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.
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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 § 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 § 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
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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 § 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 § 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, airpermeable paper envelope) or an
attached heavy paper fold-over flap
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container placed into a secondary highquality 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 § 173.199(d) to § 173.134(b)(12)(ii).
Section 173.196. We are modifying
the Division 6.2 material packaging
requirements in § 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 § 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
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transported in accordance with the
provisions in § 173.199.
Section 173.197. We are modifying
the RMW packaging requirements in
§ 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 § 173.197(b) for
clarification by correcting in the first
sentence, ‘‘except as otherwise provided
in § 173.134 of this subpart’’ to read
‘‘except as authorized by § 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 § 173.197(d)(2)(iii), the reference to
the drop test requirement prescribed in
§ 178.603 for non-bulk packagings is not
correct. It should read ‘‘Each Cart must
be capable of meeting the requirements
of § 178.810 (drop test) at the Packing
Group II performance level.’’ This
section contains the drop test
requirements for an intermediate bulk
packaging.
In § 173.197(e)(3), in the introductory
paragraph, we are revising the wording
‘‘the performance tests in § 178.601’’ to
read ‘‘the performance tests in part 178,
subpart M’’. There are no performance
tests in § 178.601. This revision makes
§ 173.197(e)(3) consistent with
§ 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 § 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 §§ 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
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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 § 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-onpoint 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.
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Category B infectious substances
prepared in accordance with § 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 § 173.199(d) for
used health care products are relocated
to § 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
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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.
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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
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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 nonspecification 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 ×
$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
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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
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transportation of infectious substances
with international standards.
Federal hazardous materials
transportation law provides at
§ 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.
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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;
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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.
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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,
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2000 (Volume 65, Number 70; Pages
19477–78) or you may visit https://
dms.dot.gov.
reference, Radioactive materials,
Reporting and recordkeeping
requirements.
List of Subjects
I
49 CFR Part 171
Exports, Hazardous materials
transportation, Hazardous waste,
Imports, Incorporation by reference,
Reporting and recordkeeping
requirements.
PART 171—GENERAL INFORMATION,
REGULATIONS, AND DEFINITION
In consideration of the foregoing, we
are amending 49 CFR parts 171, 172,
173, and 175 as follows:
1. The authority citation for part 171
continues to read as follows:
I
49 CFR Part 172
Education, Hazardous materials
transportation, Hazardous waste,
Incorporation by reference, Labeling,
Markings, Packaging and containers,
Reporting and recordkeeping
requirements.
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.
§ 171.8
49 CFR Part 173
Hazardous materials transportation,
Incorporation by reference, Packaging
and containers, Radioactive materials,
Reporting and recordkeeping
requirements, Uranium.
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49 CFR Part 175
Air carriers, Hazardous materials
transportation, Incorporation by
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[Amended]
2. In § 171.8, the definition for ‘‘Risk
Group’’ is removed.
I
PART 172—HAZARDOUS MATERIALS
TABLE, SPECIAL PROVISIONS,
HAZARDOUS MATERIALS
COMMUNICATIONS, EMERGENCY
RESPONSE INFORMATION, AND
TRAINING REQUIREMENTS
Authority: 49 U.S.C. 5101–5127; 49 CFR
1.53.
4. In § 172.101, in the Hazardous
Materials Table, the following changes
are made:
I a. The entry ‘‘Diagnostic specimen’’ is
removed.
I b. The entry ‘‘Biological substance,
Category B’’ is added in appropriate
alphabetic order.
I 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:
I
§ 172.101 Purpose and use of hazardous
materials table.
*
*
*
3. The authority citation for part 172
continues to read as follows:
I
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02JNR2
*
*
VerDate Aug<31>2005
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G .................
G .................
G .................
(1)
Symbols
Regulated medical
waste, n.o.s.
Infectious substances, affecting
animals only.
Infectious substances, affecting
humans.
Biological substance,
Category B.
(2)
Hazardous materials
descriptions and
proper shipping
names
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*
*
*
*
(3)
6.2
6.2
6.2
6.2
Hazard
class or
Division
UN3291 ....
UN 2814 ...
UN2900 ....
UN3373 ....
(4)
Identification numbers
*
*
*
*
II ...............
...................
...................
...................
(5)
PG
Frm 00015
*
*
6.2 ............................
6.2 ............................
*
6.2 ............................
*
...................................
(6)
Label Codes
*
*
A13 ...........
A82 ...........
*
A82 ...........
*
A82 ...........
(7)
Special
provisions
*
*
134 ...........
134 ...........
*
134 ...........
*
134 ...........
(8A)
Exceptions
197 ...........
196 ...........
196 ...........
199 ...........
(8B)
Non-bulk
(8C)
Bulk
*
*
197 ...........
None .........
*
None .........
*
None .........
(8)
Packaging (§ 173.* * *)
*
*
No limit .....
50 mL or
50 g.
*
50 mL or
50 g.
*
4 L or 4 kg
(9A)
Passenger
aircraft/ rail
No limit .....
4 L or 4 kg
4 L or 4 kg
4 L or 4 kg
(9B)
Cargo aircraft only
(9)
Quantity limitations
B ...............
B ...............
B ...............
A ...............
(10A)
Location
40
40
40
40
(10B)
Other
(10)
Vessel stowage
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§ 172.102
Federal Register / Vol. 71, No. 106 / Friday, June 2, 2006 / Rules and Regulations
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PART 173—SHIPPERS—GENERAL
REQUIREMENTS FOR SHIPMENTS
AND PACKAGINGS
[Amended]
5. In § 172.102, in paragraph (c)(2),
Special Provision A81 is removed.
I 6. In § 172.200, paragraph (b)(4) is
added to read as follows:
I
§ 172.200
9. The authority citation for part 173
continues to read as follows:
I
Authority: 49 U.S.C. 5101–5127, 44701; 49
CFR 1.45, 1.53.
Applicability.
*
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*
(b) * * *
(4) Category B infectious substances
prepared in accordance with § 173.199.
I 7. In § 172.203, in paragraph (k)
introductory text a sentence is added
after the last sentence to read as follows:
§ 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.
*
*
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*
I 8. In § 172.301, paragraph (b) is
revised to read as follows.
§ 172.301 General marking requirements
for non-bulk packagings.
*
*
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*
*
(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 § 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
§ 172.203(k) of this part. A technical
name should not be marked on the outer
package of a Division 6.2 material.
*
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I 9. In § 172.800, paragraph (b)(6) is
revised to read as follows:
§ 172.800
Purpose and applicability.
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(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
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10. In § 173.6, paragraph (a)(4) is
revised to read as follows:
I
§ 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).
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I 11. In § 173.24a, paragraph (c)(2) is
revised to read as follows:
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§ 173.24a Additional general requirements
for non-bulk packagings and packages.
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(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.
*
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*
I 12. In § 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:
§ 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
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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.
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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.
*
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(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 microorganisms 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
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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 § 173.196
or § 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.
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(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;
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(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 § 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 § 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 § 173.197, if packaged
in a rigid non-bulk packaging
conforming to the general packaging
requirements of §§ 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 §§ 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
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be securely closed to prevent leaks or
punctures.
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I 13. In § 173.196, the section title and
paragraphs (a) introductory text, (a)(2),
(a)(3), and (b) are revised, to read as
follows.
§ 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 § 178.609 of this
subchapter and must be marked in
conformance with § 178.503(f) of this
subchapter. A packaging for a Category
A infectious substance is a triple
packaging consisting of the following
components:
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(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.
*
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(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 § 178.503 of
this subchapter. Interior supports must
be provided to secure the secondary
packagings in the original position after
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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
§ 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
§ 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.
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I 14. In § 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:
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§ 173.197
Regulated medical waste.
(a) General provisions. Non-bulk
packagings, Large Packagings, and nonspecification 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 § 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
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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
§ 178.2(c) of this subchapter.
*
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(d) * * *
(1) * * *
(iv) Untreated concentrated stock
cultures of infectious substances
containing Category A materials may
not be transported in a Cart or BOP.
*
*
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*
(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 § 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.
*
*
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*
*
(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
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sharps container may be reused only if
it conforms to the following criteria:
*
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15. In § 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:
§ 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
§§ 171.15 and 171.16 of this subchapter
and to the requirements in § 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 §§ 178.609(d) and (h) of this
subchapter at a drop height of at least
1.2 meters (3.9 feet). Following the drop
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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.
(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
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19:07 Jun 01, 2006
Jkt 208001
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
PO 00000
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Fmt 4701
Sfmt 4700
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 § 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
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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
16. The authority citation for part 175
continues to read as follows:
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I
VerDate Aug<31>2005
19:07 Jun 01, 2006
Jkt 208001
Authority: 49 U.S.C. 5101–5127; 49 CFR
1.53.
17. In § 175.630, the section heading
is revised and paragraph (c) is added to
read as follows:
I
§ 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
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Fmt 4701
Sfmt 4700
32263
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
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]]>Agencies
[Federal Register Volume 71, Number 106 (Friday, June 2, 2006)]
[Rules and Regulations]
[Pages 32244-32263]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-4992]
[[Page 32243]]
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Part III
Department of Transportation
-----------------------------------------------------------------------
Pipeline and Hazardous Materials Safety Administration
-----------------------------------------------------------------------
49 CFR Parts 171, 172, 173, and 175
Hazardous Materials: Infectious Substances; Harmonization With the
United Nations Recommendations; Final Rule
Federal Register / Vol. 71, No. 106 / Friday, June 2, 2006 / Rules
and Regulations
[[Page 32244]]
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DEPARTMENT OF TRANSPORTATION
Pipeline and Hazardous Materials Safety Administration
49 CFR Parts 171, 172, 173, and 175
[Docket No. PHMSA-2004-16895 (HM-226A)]
RIN 2137-AD93
Hazardous Materials: Infectious Substances; Harmonization With
the United Nations Recommendations
AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
Department of Transportation (DOT).
ACTION: Final rule.
-----------------------------------------------------------------------
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.
------------------------------------------------------------------------
Category A infectious substances UN
No. and proper shipping name Micro-organism
------------------------------------------------------------------------
UN 2814--Infectious substances Bacillus anthracis (cultures
affecting humans and animals. only).
Brucella abortus (cultures
only).
Brucella melitensis (cultures
only).
Brucella suis (cultures only).
Burkholderia mallei--
Pseudomonas mallei--Glanders
(cultures only).
Burkholderia pseudomallei--
Pseudomonas pseudomallei
(cultures only).
Chlamydia psittaci--avian
strains (cultures only).
Clostridium botulinum (cultures
only).
Coccidioides immitis (cultures
only).
Coxiella burnetti (cultures
only).
Crimean-Congo hemorrhagic fever
virus.
Dengue virus (cultures only).
Eastern equine encephalitis
virus (cultures only).
Escherichia coli, verotoxigenic
(cultures only).
Ebola virus.
Flexal virus.
Francisella tularensis
(cultures only).
Guanarito virus.
Hantaan virus.
Hantaviruses causing
hemorrhagic fever with renal
syndrome.
Hendra virus.
Herpes B virus (cultures only).
Human immunodeficiency virus
(cultures only).
Highly pathogenic avian
influenza virus (cultures
only).
Japanese Encephalitis virus
(cultures only).
Junin virus.
Kyasanur forest disease virus.
Lassa virus.
Machupo virus.
Marburg virus.
Monkeypox virus.
Mycobacterium tuberculosis
(cultures only).
Nipah virus.
[[Page 32246]]
Omsk hemorrhagic fever virus.
Poliovirus (cultures only).
Rabies and other lyssaviruses
(cultures only).
Rickettsia prowazekii (cultures
only).
Rickettsia rickettsia (cultures
only).
Rift Valley fever virus
(cultures only).
Russian spring-summer
encephalitis virus (cultures
only).
Sabia virus.
Shigella dysenteriae type I
(cultures only).
Tick-borne encephalitis virus
(cultures only).
Variola virus.
Venezuelan equine encephalitis
virus (cultures only).
Vesicular stomatitis virus
(cultures only).
West Nile virus (cultures
only).
Yellow fever virus (cultures
only).
Yersinia pestis (cultures
only).
UN 2900--Infectious substances African swine fever virus
affecting animals only. (cultures only).
Avian paramyxovirus Type 1--
Velogenic Newcastle disease
virus (cultures only).
Classical swine fever virus
(cultures only).
Foot and mouth disease virus
(cultures only).
Lumpy skin disease virus
(cultures only).
Mycoplasma mycoides--Contagious
bovine pleuropneumonia
(cultures only).
Peste des petits ruminants
virus (cultures only).
Rinderpest virus (cultures
only).
Sheep-pox virus (cultures
only).
Goatpox virus (cultures only).
Swine vesicular disease virus
(cultures only).
------------------------------------------------------------------------
A Category B infectious substance is one that does not meet the
criteria for inclusion in Category A. A Category B infectious substance
does not cause permanent disability or life-threatening or fatal
disease to humans or animals when exposure to it occurs. Under the
provisions of the 13th Edition of the UN Recommendations, adopted in
December 2002, a Category B infectious substance is described as
``Diagnostic Specimen'' or ``Clinical Specimen'' and assigned to UN
3373.
Currently, the HMR define a ``diagnostic specimen'' to mean any
human or animal material being transported for diagnostic or
investigative purposes. In accordance with current Sec. 173.199,
diagnostic specimens are excepted from most HMR requirements except for
minimal packaging and hazard communication. Historically, the HMR have
permitted a proper shipping name, such as ``Diagnostic specimen,''
listed in the Sec. 172.101 Table to be used to describe a non-
hazardous material on a shipping paper and package marking provided the
UN or NA identification number is not included. See Sec. Sec.
172.202(e) and 172.303(b)(3). However, adoption of the proper shipping
name ``Diagnostic specimen'' in both the international standards and
the HMR resulted in some confusion on the part of both shippers and
carriers who are accustomed to using these terms to refer to human or
animal samples that have a low probability of containing an infectious
pathogen. In addition, using these terms to describe shipments of
Category B infectious substances is not completely accurate--there are
many shipments of Category B infectious substances that may not be
diagnostic specimens as that term is usually defined.
The UN Sub-Committee of Experts on the Transport of Dangerous Goods
discussed the proper shipping name issue during its July 2004 meeting
and agreed to adopt a different proper shipping name for Category B
infectious substances--``Biological substance, Category B.'' The UN
adopted this proper shipping name for the 14th Revised Edition of the
UN Recommendations, which is effective January 1, 2007; ICAO adopted
the new proper shipping name through an addendum to the 2005-2006 ICAO
Technical Instructions. The addendum permits use of the new proper
shipping name as an alternative to ``Diagnostic Specimen'' or
``Clinical Specimen'' until January 1, 2007, at which time the new name
must be used. Consistent with the revised international standards, the
May 9, 2005 NPRM proposed to adopt the proper shipping name
``Biological substance, Category B'' in the HMR. No commenters opposed
this proposal, and it is adopted in this final rule. Thus, a Category B
infectious substance must be described as ``Biological substance,
Category B'' and assigned to UN 3373.
B. Packaging Requirements for Category B Infectious Substances
Currently, the HMR require Risk Group 2 and 3 infectious substances
(most of which will be classed as Category B infectious substances
under this final rule) to be transported in triple packagings certified
to comply with the performance standards in Sec. 178.609, including a
drop test from a height of 9 m (30 ft), a water spray test, and a
puncture test. In the NPRM, we proposed to permit Category B infectious
substances to be transported in non-specification triple packagings
capable of passing a drop test only at a height of 1.2 meters (3.9
feet). Commenters support this proposal. We are adopting this
requirement in this final rule.
The NPRM proposed to require these packagings to be capable of
passing the drop test set forth in Sec. 178.603, which prescribes
tests for all non-bulk packaging designs. As suggested by one commenter
(TEN-E), in this final rule, we are replacing the reference to Sec.
178.603 with Sec. 178.609. The drop test established in Sec. 178.609
applies specifically to infectious substance packagings; this testing
configuration more appropriately addresses the integrity issues for
infectious substance packages.
[[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 syste
