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Definitions
Basic
Packaging Definitions
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Other
Useful Definitions
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Defining
your shipment category
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US
DOT |
IATA |
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US
DOT - "Inner packaging means a packaging for which
an outer packaging is required for transport. It does not
include the inner receptacle of a composite packaging."
49
CFR 171.8 (10-1-2004 Edition)
US
DOT FINAL RULE (Effective Oct.
1, 2006)- No changes were made. HM-226A
Final rule; Effective Date 10/1/2006; 71 FR 32243
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"Are
packagings for which an outer packaging is required for transport.
(NOTE:
The "inners" of "combination packagings"
are always termed "inner packagings" not "inner
receptacles". A glass bottle is an example of such an
"inner packaging".)" IATA DGR 46th edition
Appendix A |
EXAKT-PAK® Note: Inner packagings are comprised of the
primary container (supplied by you unless otherwise
noted), sufficient absorbent to absorb the entire contents,
and the secondary container. All our secondary containers
have been independently tested and meet the 95 kPa
requirement.
If
your primary container can meet the 95 kPa requirement,
it can serve as both the primary and secondary container
when contained with sufficient absorbent in one of
our biohazard bags.
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to Definitions
Back
to Definitions
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US
POSTAL
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US
Postal - "Secondary container is the packaging
component into which the primary receptacle(s) and
any required absorbent and cushioning material is securely
placed. The packaging of certain mailable hazardous
materials does not require the use of a secondary container." DMM
Issue (8-7-2005) 601.10.1
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to Definitions
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US
DOT
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IATA
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US
Postal
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US
DOT - "Outer packaging means 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." 49
CFR 171.8 (10-1-2004 Edition)
US
DOT FINAL RULE (Effective Oct.
1, 2006)- No changes were made. HM-226A
Final rule; Effective Date 10/1/2006; 71 FR 32243
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"The
outer protection 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." IATA DGR 46th edition Appendix A |
"Outer
shipping container is the exterior packaging component into
which a primary receptacle, along with any required absorbent
and cushioning material, and the secondary container (if required)
are securely placed. The outer shipping container bears the
addressing information along with all required markings."
DMM
Issue (8-7-2005) 601.10.1 |
Back
to Definitions
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US
DOT
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IATA
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US
DOT - "Combination packaging means a combination
of packaging, for transport purposes, consisting of
one or more inner packagings secure in a non-bulk outer
packaging. It does not include a composite packaging." 49
CFR 171.8 (10-1-2004 Edition)
US
DOT FINAL RULE (Effective Oct.
1, 2006)- No changes were made. HM-226A
Final rule; Effective Date 10/1/2006; 71 FR 32243
|
"Are
a combination of packagings for transport purposes, consisting
of one or more inner packagings secured in an outer packaging
in accordance with the relevant provisions in Section 5."
IATA DGR 46th edition Appendix A |
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to Other Useful Definitions
Back
to Other Useful Definitions
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US
DOT
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IATA
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US
DOT - "Overpack, except as provided in subpart
K of part 178 of this subchapter, means an enclosure
that is used by a single consignor to provide protection
or convenience in handling of a package or to consolidate
two or more packages. Overpack does not include a transport
vehicle, freight container, or aircraft unit load device.
Examples of overpacks are one or more packages:
(1)
Placed or stacked onto a load board such as a pallet
and secured by strapping, shrink wrapping, stretch
wrapping, or other suitable means; or
(2)
Placed in a protective outer packaging such as a
box or crate." 49
CFR 171.8 (10-1-2004 Edition)
US
DOT FINAL RULE (Effective Oct.
1, 2006)- No changes were made. HM-226A
Final rule; Effective Date 10/1/2006; 71 FR 32243
|
"An
enclosure used by a single shipper to contain one or more
packages and to form one handling unit for convenience of
handling and stowage. Dangerous goods packages contained
in the overpack must be properly packed, marked, labeled,
and in proper condition as required by these Regulations.
For
cooling purposes, an overpack may contain Carbon dioxide,
solid (dry ice), provided that the overpack meets the
requirements of Packing Instruction 904. (A Unit Load
Device is not included in this definition.)" IATA
DGR 46th edition Appendix A |
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to Other Useful Definitions
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IATA
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"Are
packagings to be filled which have been examined and found
free of defects affecting the ability to withstand the performance
tests; the term includes those which are transported with
distribution chains controlled by the shipper of the product."
IATA DGR 46th edition Appendix A
Packagings,
including closures, which have been used more than
once, i.e. they have been refilled and being re-shipped
after having previously been emptied, must be inspected
thoroughly and must be in such condition that they
will protect their contents and perform their containment
functions as efficiently as new packagings. Cushioning
and absorbent materials, in used previously, must remain
capable of performing their primary functions. IATA
DGR 46th edition 2.8.3.2 |
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US
DOT
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IATA
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US
DOT - "Packaging group means a grouping according
to the degree of danger presented by hazardous materials.
Packing Group I indicates great danger; Packing Group
II, medium danger; Packing Group III, minor danger.
See 172.101(f) of
this subchapter." 49
CFR 171.8 (10-1-2004 Edition)
US
DOT FINAL RULE (Effective Oct.
1, 2006)- No changes were made. HM-226A
Final rule; Effective Date 10/1/2006; 71 FR 32243
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"An
indication of the relative degree of danger presented by
various articles and substances within a class or division.
Roman numerals I, II, and III are used to represent "high
danger", "medium danger" and "low danger"
respectively." IATA DGR 46th edition Appendix A
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to Other Useful Definitions
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US
DOT
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IATA
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US
DOT - "Proper shipping name means the name of
the hazardous material show in Roman print (not italics)
in 172.101 of
this subchapter." 49
CFR 171.8 (10-1-2004 Edition)
US
DOT FINAL RULE (Effective Oct.
1, 2006)- No changes were made. HM-226A
Final rule; Effective Date 10/1/2006; 71 FR 32243
|
"The
name to be used to describe a particular article or substance
in all shipping documents and notifications and, where appropriate,
on packaging. (NOTE: These names are indicated in the bold
face characters in the List of Dangerous Goods located in
Section 4 of IATA)." IATA DGR 46th edition Appendix
A
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to Other Useful Definitions
INFECTIOUS
SUBSTANCE/BIOLOGICAL SUBSTANCE CATEGORY A
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US
DOT
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US
DOT - "Division 6.2 (infectious substance) means
a material known to contain or suspected of containing
a pathogen. A pathogen is a virus or micro-organism
(including its viruses, plasmids, or other genetic
elements, if any) or a proteinaceous infectious particle
(prion) that has the potential to cause disease in
humans or animals. A Division 6.2 material must be
assigned to a risk group in accordance with this paragraph
(a). Assignment to a risk group is based on known medical
condition and history of the source patient or animal,
endemic local conditions, symptoms of the source patient
or animal, or professional judgment concerning individual
circumstances of the source patient or animal. Infectious
substances are subject to applicable requirements in
42 CFR Part 72— Interstate Shipment of Etiologic
Agents." 49
CFR 173.134 (10-1-2004 Edition)
US
DOT FINAL (Effective Oct. 1,
2006) - "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 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."
HM-226A
Final rule; Effective Date 10/1/2006; 71 FR 32243
|
IATA |
|
"Infectious
substances are substances which are known or are reasonably
expected to contain pathogens. Pathogens are defined as
micro-organisms (including bacteria, viruses, rickettsiae,
parasites, fungi) and other agents such as prions, which
can cause disease in humans or animals. (Note: Toxins from
plant, animal or bacterial sources which do not contain
any infectious substances or toxins that are not contained
in substances which are infectious substances should be
considered for classification in Division 6.1 and assigned
to UN3172.)" IATA
DGR 46th edition 3.6.2.1.1
"Infectious
substances must be classified in Division 6.2 and assigned
to UN 2814, UN 2900, UN 3291, or UN3373, as appropriate." IATA
DGR 46th edition Addendum II Posted March 22, 2005 3.6.2.2.1.
3.6.2.2.2 Infectious
substances are divided into the following categories.
Category
A: An infectious substance which is transported
in a form that, when exposure to it occurs, is
capable of causing permanent disability, life-threatening
or fatal disease in otherwise healthy humans or
animals. Indicative examples of substances that
meet these criteria are given in Table
3.6.D. (Amendments
to Table 3.6.D. published in Addendum II)
Note:
An exposure occurs when an infectious substance is
released outside of the protective packaging, resulting
in physical contact with human or animals.
(a)
Infectious substances meeting these criteria which
cause disease in humans or both in humans and animals
must be assigned to UN 2814. Infectious substances
which cause disease only in animals must be assigned
to UN 2900.
(b)
Assignment to UN 2814 or UN 2900 must be based on the
known medical history and symptoms of the source human
or animal, endemic local conditions, or professional
judgment concerning individual circumstances of the
source human or animal.
Notes:
1.
The proper shipping name for UN 2814 is Infectious
substance, affecting humans. The proper shipping
name for UN 2900 is Infectious substance, affecting
animals only.
2.
The table is
not exhaustive. Infectious substances, including
new or emerging pathogens, which do not appear in
the table,
but which meet the same criteria must be assigned
to Category A. In addition, if there is doubt as
to whether or not a substance meets the criteria
it must be included in Category A.
3.
In the table,
the microorganisms written in italics are bacteria,
mycoplasma, rickettsia or fungi.
Category
B: An infectious substance which does not
meet the criteria for inclusion in Category A.
Infectious substances in Category B must be assigned
to UN 3373. (Note: The proper shipping name of
UN 3373 is Diagnostic specimens, Clinical specimens
or Biological substance category B. On 1
January 2007 it is anticipated that the use of
the shipping names Diagnostic specimens and Clinical
specimens will no longer be permitted.)
3.6.2.2.3.1 Substances
which do not contain infectious substances or substances
which are unlikely to cause disease in humans or animals
are not subject to these Regulations unless they meet
the criteria for inclusion in another class. IATA
DGR 46th edition Addendum III Posted July 5, 2005
3.6.2.2.3.2 Substances
containing micro-organisms, which are non-pathogenic
to humans or animals are not subject to these Regulations
unless they meet the criteria for inclusion in another
class. IATA
DGR 46th edition Addendum III Posted July 5, 2005
3.6.2.2.3.3 Substances
in a form that any present pathogens have been neutralized
or inactivated such that they no longer pose a health
risk are not subject to these Regulations unless they
meet the criteria for inclusion in another class. IATA
DGR 46th edition Addendum III Posted July 5, 2005
3.6.2.2.3.4 Environmental
samples (including food and water samples), which are
not considered to pose a significant risk of infection,
are not subject to these Regulations unless they meet
the criteria for inclusion in another class. IATA
DGR 46th edition Addendum III Posted July 5, 2005
3.6.2.2.3.5 Dried
blood spots, collected by applying a drop of blood onto
absorbent material, or fecal occult blood screening tests
and blood or blood components which have been collected
for the purposes of transfusion or for the preparation
of blood products to be used for transfusion or transplantation
and any tissues or organs intended for use in transplantation
are not subject to these Regulations. IATA
DGR 46th edition Addendum III Posted July 5, 2005
3.6.2.6.1 A
live animal which has been intentionally infected and
is known or suspected to contain an infectious substance
must only be transported by air unless the infectious
substance contained cannot be consigned by any other
means. Infected animals may only be transported under
terms and conditions approved by the appropriate national
authority. IATA
DGR 46th edition Addendum III Posted July 5, 2005
3.6.2.6.2 Unless
an infectious substance cannot be consigned by any other
means, live animals must not be used to consign such
a substance. IATA
DGR 46th edition Addendum III Posted July 5, 2005
3.6.2.6.3 Animal
carcasses affected by pathogens of Category A or which
would be assigned to Category A in cultures only, must
be assigned to UN 2814 or UN 2900 as appropriate. Other
animal carcasses affected by pathogens included in Category
B must be transported in accordance with provisions determined
by the competent authority. IATA
DGR 46th edition Addendum III Posted July 5, 2005 |
US
POSTAL |
| "Division
6.2 (infectious substance) means a material known to contain
or suspected of containing a pathogen. A pathogen is a virus
or microorganism (including its viruses, plasmids, or other
genetic elements, if any) or a proteinaceous infectious particle
(prion) that has the potential to cause disease in humans
or animals. A Division 6.2 material must be assigned to a
risk group as defined in 10.17.2f.
Assignment to a risk group is based on the known medical condition
and 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. Infectious substances are subject to applicable
requirements in 42 CFR 72 (Interstate Shipment of Etiologic
Agents)." DMM
Issue (8-7-2005) 601.10.17.2 |
CDC |
| "Etiologic
agent means a viable microorganism or its toxin which causes,
or may cause, human disease." 42
CFR 72.1 (10-1-2004 Edition) |
OSHA |
|
"Bloodborne
Pathogens means pathogenic microorganisms that are present
in human blood and can cause disease in humans. These pathogens
include, but are not limited to, hepatitis B virus (HBV)
and human immunodeficiency virus (HIV)."
"Other
Potentially Infectious Materials
(1)
The following human body fluids: semen, vaginal secretions,
cerebrospinal fluid, synovial fluid, pleural fluid,
pericardial fluid, peritoneal fluid,amniotic fluid,
saliva in dental procedures, any body fluid that is
visibly contaminated with blood, and all body fluids
in situations where it is difficult or impossible to
differentiate between body fluids;
(2)
Any unfixed tissue or organ (other than intact skin)
from a human (living or dead); and
(3)
HIV-containing cell or tissue cultures, organ cultures,
and HIV- or HBV containing culture medium or other
solutions; and blood, organs, or other tissues from
experimental animals infected with HIV or HBV."
29
CFR 1910.1030 (7-1-2005 Edition) |
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DIAGNOSTIC
SPECIMEN/BIOLOGICAL SUBSTANCE CATEGORY B
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US
DOT
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US
DOT - "Diagnostic specimen means any human or animal
material, including excreta, secreta, blood and its
components, tissue, and tissue fluids being transported
for diagnostic or investigational purposes, but excluding
live infected humans or animals. A diagnostic specimen
is not assigned a UN identification number unless the
source patient or animal has or may have a serious
human or animal disease from a Risk Group 4 pathogen,
in which case it must be classed as Division 6.2, described
as an infectious substance, and assigned to UN 2814
or UN 2900, as appropriate. Assignment to UN 2814 or
UN 2900 is based on known medical condition and history
of the patient or animal, endemic local conditions,
symptoms of the source patient or animal, or professional
judgment concerning individual circumstances of the
source patient or animal.." 49
CFR 173.134 (10-1-2004 Edition)
US
DOT FINAL (Effective Oct. 1,
2006) - "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."
HM-226A
Final rule; Effective Date 10/1/2006; 71 FR 32243
|
IATA |
| "Biological
Substance, Category B: An infectious substance
which does not meet the criteria for inclusion in Category
A. Infectious substances in Category B must be assigned to
UN 3373. (Note: The proper shipping name of UN 3373 is Diagnostic
specimens, Clinical specimens or Biological substance category
B. On 1 January 2007 it is anticipated that the use
of the shipping names Diagnostic specimens and Clinical specimens
will no longer be permitted.)" IATA
DGR 46th edition 3.6.2.2.2.2 |
US
POSTAL |
| "Diagnostic
(clinical) specimen means any human or animal material, including
excreta, secreta, blood and its components, tissue, and tissue
fluids being transported for diagnostic or investigational
purposes, but excluding live infected animals. A diagnostic
specimen is not assigned a UN identification number unless
the source patient or animal has or may have a serious human
or animal disease from a Risk Group 4 pathogen, in which case
it must be classed as Division 6.2, described as an infectious
substance, and assigned to UN 2814 or UN 2900, as appropriate.
Assignment to UN 2814 or UN 2900 is based on known medical
condition and history of the patient or animal, endemic local
conditions, symptoms of the source patient or animal, or professional
judgment concerning individual circumstances of the source
patient or animal." DMM
Issue (8-7-2005) 601.10.17.2 |
CDC |
| "Diagnostic
specimen means any human or animal material including, but
not limited to, excreta, secreta, blood and its components,
tissue, and tissue fluids being shipped for purposes of diagnosis."
42
CFR 72.1 (10-1-2004 Edition) |
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to Other Useful Definitions
EXEMPT
HUMAN SPECIMEN OR EXEMPT ANIMAL SPECIMEN
|
US DOT |
US
DOT - "Exempt
human specimen" and "Exempt animal
specimen" are not currently recognized as categories
in the current regulations.
US DOT
Proposed - 173.134(b)(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 that is 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 noninfectious diseases, such as cancer biopsies, and for which there is
a low probability that the sample is infectious.
|
IATA |
|
3.6.2.2.3.1
Substances which do not contain infectious substances or
substances which are unlikely to cause disease in humans
or animals are not subject to these Regulations unless they
meet the criteria for inclusion in another class. IATA
DGR 46th edition Addendum III Posted July 5, 2005
3.6.2.2.3.2 Substances
containing micro-organisms, which are non-pathogenic
to humans or animals are not subject to these Regulations
unless they meet the criteria for inclusion in another
class. IATA
DGR 46th edition Addendum III Posted July 5, 2005
3.6.2.2.3.3 Substances
in a form that any present pathogens have been neutralized
or inactivated such that they no longer pose a health
risk are not subject to these Regulations unless they
meet the criteria for inclusion in another class. IATA
DGR 46th edition Addendum III Posted July 5, 2005
3.6.2.2.3.4 Environmental
samples (including food and water samples), which are
not considered to pose a significant risk of infection,
are not subject to these Regulations unless they meet
the criteria for inclusion in another class. IATA
DGR 46th edition Addendum III Posted July 5, 2005
3.6.2.2.3.5 Dried
blood spots, collected by applying a drop of blood onto
absorbent material, or fecal occult blood screening tests
and blood or blood components which have been collected
for the purposes of transfusion or for the preparation
of blood products to be used for transfusion or transplantation
and any tissues or organs intended for use in transplantation
are not subject to these Regulations. IATA
DGR 46th edition Addendum III Posted July 5, 2005
3.6.2.2.3.6 Patient
specimens for which there is minimal likelihood that
pathogens are present are not subject to these Regulations
if the specimen is transported in a packaging which will
prevent any leakage and which is marked with the words "Exempt
human specimen" or "Exempt animal specimen",
as appropriate. The packaging must meet the following
conditions:
(a)
The packaging must consist of three components:
(1)
a leak-proof primary receptacle(s);
(2) a leak-proof secondary packaging; and
(3) an outer packaging of adequate strength for its capacity, mass and
intended use, and with at least one surface having minimum dimensions of
100 mm × 100 mm;
(b)
For liquids, absorbent material in sufficient quantity
to absorb the entire contents must be placed between
the primary receptacle(s) and the secondary packaging
so that, during transport, any release or leak of a
liquid substance will not reach the outer packaging
and will not compromise the integrity of the cushioning
material;
(c)
When multiple fragile primary receptacles are placed
in a single secondary packaging, they must be either
individually wrapped or separated to prevent contact
between them.
NOTE:
In determining whether a patient specimen has a minimal
likelihood that pathogens are present, an element of
professional judgment is required to determine if a
substance is exempt under this paragraph. That judgment
should be based on the known medical history, symptoms
and individual circumstances of the source, human or
animal, and endemic local conditions. Examples of specimens
which may be transported under this paragraph include
the blood or urine tests to monitor cholesterol levels,
blood glucose levels, hormone levels, or prostate specific
antigens (PSA); tests required to monitor organ function
such as heart, liver or kidney function for humans
or animals with non-infectious diseases, or therapeutic
drug monitoring; tests conducted for insurance or employment
purposes and are intended to determine the presence
of drugs or alcohol; pregnancy tests; biopsies to detect
cancer; and antibody detection in humans or animals." IATA
DGR 46th edition Addendum III Posted July 5, 2005
|
US
POSTAL |
| "Exempt
human specimen" and "Exempt animal specimen"
are not currently recognized as categories in the current
regulations.
|
Back
to Other Useful Definitions
|
|
US
DOT
|
|
US
DOT - "Biological product means a virus, therapeutic
serum, toxin, antitoxin, vaccine, blood, blood component
or derivative, allergenic product, or analogous product
used in the prevention, diagnosis, treatment, or cure
of diseases in humans or animals. A biological product
includes a material manufactured and distributed in
accordance with one of the following provisions: 9
CFR part 102 (Licenses for Biological Products); 9
CFR part 103 (Experimental Products, Distribution,
and Evaluation of Biological Products Prior to Licensing); 9
CFR part 104 (Permits for Biological Products); 21
CFR part 312 (Investigational New Drug Application); 21
CFR part 314 (Applications for FDA Approval to
Market a New Drug); 21
CFR parts 600 to 680 (Biologics); or 21
CFR part 812 (Investigational Device Exemptions).
A biological product known to contain or suspected
of containing a pathogen in Risk Group 2, 3, or 4 must
be classed as Division 6.2, described as an infectious
substance, and assigned to UN 2814 or UN 2900, as appropriate,
unless otherwise excepted." 49
CFR 173.134 (10-1-2004 Edition)
US
DOT FINAL (Effective Oct. 1,
2006) - "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.HM-226A
Final rule; Effective Date 10/1/2006; 71 FR 32243
|
IATA
|
|
"For
the purposes of these Regulations, biological products are
divided into the following groups:
(a)
those which are manufactured and packaged in accordance
with the requirements of appropriate national authorities
and transported for the purposes of final packaging
or distribution, and use for personal health care by
medical professionals or individuals. Substances in
this group are not subject to these Regulations.
(b)
those which do not fall under paragraph (a) and are
known or reasonably believed to contain infectious
substances and which meet the criteria for inclusion
in Category A or Category B. Substances in this group
must be assigned to UN2814, UN2900 or UN3373, as appropriate.
Note: Some
licensed biological products may present a biohazard
only in certain parts of the world. In that case, competent
authorities may require these biological products to
be in compliance with local requirements for infectious
substances or may impose other restrictions." IATA
DGR 46th edition 3.6.2.3 |
US
POSTAL
|
| "Biological
product means a virus, therapeutic serum, toxin, antitoxin,
vaccine, blood, blood component or derivative, allergenic
product, or analogous product used in the prevention, diagnosis,
treatment, or cure of diseases in humans or animals. A biological
product includes a material manufactured and distributed in
accordance with one of the following provisions: 9
CFR part 102 (Licenses for Biological Products); 9
CFR part 103 (Experimental Products, Distribution, and
Evaluation of Biological Products Prior to Licensing); 9
CFR part 104 (Permits for Biological Products); 21
CFR part 312 (Investigational New Drug Application); 21
CFR part 314 (Applications for FDA Approval to Market
a New Drug); 21
CFR parts 600 to 680 (Biologics); or 21
CFR part 812 (Investigational Device Exemptions). A biological
product known to contain or suspected of containing a pathogen
in Risk Group 2, 3, or 4 must be classed as Division 6.2,
described as an infectious substance, and assigned to UN 2814
or UN 2900, as appropriate, unless otherwise excepted by standard."
DMM
Issue (8-7-2005) 601.10.17.2 |
CDC
|
| CDC - "Biological
product means a biological product prepared and manufactured
in accordance with the provisions of 9
CFR parts 102–104 and 21
CFR parts 312 and 600–680 and
which, in accordance with such provisions, may be shipped
in interstate traffic." 42
CFR 72.1 (10-1-2004 Edition) |
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USED
HEALTH CARE PRODUCTS
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US
DOT
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IATA
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US
Postal
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US
DOT - "Used health care product means a medical,
diagnostic, or research device or piece of equipment,
or a personal care product used by consumers, medical
professionals, or pharmaceutical providers that does
not meet the definition of a diagnostic specimen, biological
product, or regulated medical waste, is contaminated
with potentially infectious body fluids or materials,
and is not decontaminated or disinfected to remove
or mitigate the infectious hazard prior to transportation." 49
CFR 173.134 (10-1-2004 Edition)
US
DOT FINAL (Effective Oct 1,
2006) - No changes were made. HM-226A
Final rule; Effective Date 10/1/2006; 71 FR 32243
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IATA
does not currently recognize Used Health Care Products as
a classification. |
"Used
health care product means a medical, diagnostic, or research
device or piece of equipment, or a personal care product used
by consumers, medical professionals, or pharmaceutical providers
that does not meet the definition of a diagnostic specimen,
biological product, regulated medical waste, or sharps waste,
is contaminated with potentially infectious body fluids or
materials, and is not decontaminated or disinfected to remove
or mitigate the infectious hazard prior to transportation.
A used health care product classified in Risk Group 4 is nonmailable."
DMM
Issue (8-7-2005) 601.10.17.2 |
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to Other Useful Definitions
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to Other Useful Definitions
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US
DOT
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IATA
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US
DOT FINAL (Effective Oct. 1,
2006) - "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)." HM-226A
Final rule; Effective Date 10/1/2006; 71 FR 32243
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"Patient
specimens are those collected directly from humans or animals,
including, but not limited to, excreta, secreta, blood and
its components, tissue and tissue fluid swabs, and body
parts being transported for purposes such as research, diagnosis,
investigational activities, disease treatment and prevention."
IATA
DGR 46th edition Addendum III Posted July 5, 2005 3.6.2.1.4.
"Patient
specimens must be assigned to UN 2814, UN 2900 or UN
3373 as appropriate except if they comply with 3.6.2.2.3." IATA
DGR 46th edition Addendum III Posted July 5, 2005 3.6.2.7. |
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to Other Useful Definitions
GENETICALLY
MODIFIED MICROORGANISMS AND ORGANISMS
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IATA
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"Genetically
modified microorganisms not meeting the definition of an
infectious substance must be classified according to Subsection
3.9." IATA
DGR 46th edition 3.6.2.4
3.9.1.2 "Genetically
modified microorganisms (GMMOs) and genetically modified
organisms (GMOs) are microorganisms and organisms in
which genetic material has been purposely altered through
genetic engineering in a way that does not occur naturally." IATA
DGR 46th edition
3.9.2.5.1
Genetically modified organisms and microorganisms which
do not meet the definition of infectious substances
but which are capable of altering animals, plants or
microbiological substances in a way which is not normally
the result of natural reproduction. They must be assigned
to UN 3245." IATA DGR 46th edition
3.9.2.5.2
GMMOs or GMOs are not subject to these Regulations
when authorized for use by the appropriate national
authorities of the States or origin, transit and destination." IATA
DGR 46th edition |
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US
DOT
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IATA
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US
Postal
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US
DOT - "Toxin means a Division 6.1 material from
a plant, animal, or bacterial source. A toxin containing
an infectious substance or a toxin contained in an
infectious substance must be classed as Division 6.2,
described as an infectious substance, and assigned
to UN 2814 or UN 2900, as appropriate." 49
CFR 173.134 (10-1-2004 Edition)
US
DOT FINAL RULE (Effective Oct.
1, 2006) - No changes were made. HM-226A
Final rule; Effective Date 10/1/2006; 71 FR 32243
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"Division
6.1 Toxic substances are substances which are liable to
cause death or injury or to harm human health if swallowed,
inhaled or contacted by the skin." IATA DGR 46th edition
3.6.1.1.1
3.6.1.2
"To be classified as "Toxic" for purposed
of these Regulations, a substance must meet the minimum
criteria for Packing Group III shown in Tables 3.6.A (Oral,
Dermal and Dust/Mist Inhalation Hazards Division 6.1 Packing
Group Criteria) and Table 3.6.B (Vapor Inhalation Hazard--
Division 6.1 Packing Group Criteria)." IATA DGR 46th
edition
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"Toxin
means a Division 6.1 material from a plant, animal, or bacterial
source. A toxin containing an infectious substance or a
toxin contained in an infectious substance must be classed
as Division 6.2, described as an infectious substance, and
assigned to UN 2814 or UN 2900, as appropriate." DMM
Issue (8-7-2005) 601.10.17.2
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to Other Useful Definitions
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US
DOT
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US
POSTAL
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US
DOT - "Sharps means any object contaminated with
a pathogen or that may become contaminated with a pathogen
through handling or during transportation and also
capable of cutting or penetrating skin or a packaging
material. Sharps includes needles, syringes, scalpels,
broken glass, culture slides, culture dishes, broken
capillary tubes, broken rigid plastic, and exposed
ends of dental wires." 49
CFR 173.134 (10-1-2004 Edition)
US
DOT FINAL RULE (Effective Oct.
1, 2006) - No changes were made. HM-226A
Final rule; Effective Date 10/1/2006; 71 FR 32243
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"Sharps,
for USPS purposes, means any object contaminated with a
pathogen or that may become contaminated with a pathogen
through handling or during transportation and that is also
capable of cutting or penetrating skin or a packaging material.
Sharps include used medical waste such as needles, syringes,
scalpels, broken glass, culture slides, culture dishes,
broken capillary tubes, broken rigid plastic, and exposed
ends of dental wires. Sharps waste classified in Risk Group
4 is nonmailable." DMM
Issue (8-7-2005) 601.10.17.2
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NONREGULATED
MATERIALS/EXCEPTIONS
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US
DOT
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US
DOT - "Exceptions The following are not
subject to the requirements of this subchapter as Division
6.2 materials:
(1)
A biological product known to contain or suspected of containing
a microorganism in Risk Group 1, or that does not contain
a pathogen.
(2)
A diagnostic specimen known to contain or suspected of containing
a microorganism in Risk Group 1, or that does not contain
a pathogen, or a diagnostic specimen in which the pathogen
has been neutralized or inactivated so it cannot cause disease
when exposure to it occurs.
(3)
A biological product, including an experimental product
or component of a product, subject to Federal approval,
permit, or licensing requirements, such as those required
by the Food and Drug Administration of the Department of
Health and Human Services or the U.S. Department of Agriculture.
(4)
Blood collected for the purpose of blood transfusion or
the preparation of blood products; blood products; tissues
or organs intended for use in transplant operations; and
human cell, tissues, and cellular and tissue-based products
regulated under authority of the Public Health Service Act
and/or the Food, Drug, and Cosmetic Act.
(5)
Blood collected for the purpose of blood transfusion or
the preparation of blood products and sent for testing as
part of the collection process, except where the person
collecting the blood has reason to believe it contains an
infectious substance, in which case the test sample must
be shipped in accordance with § 173.199.
(6)
A diagnostic specimen or biological product when transported
by a private or contract carrier in a motor vehicle used
exclusively to transport diagnostic specimens or biological
products. Medical or clinical equipment and laboratory products
may be transported aboard the same vehicle provided they
are properly packaged and secured against exposure or contamination.
If a diagnostic specimen or biological product meets the
definition of regulated medical waste in paragraph
(a)(5) of this section, it must be offered for transportation
and transported in conformance with the appropriate requirements
for regulated medical waste.
(7)
Laundry or medical equipment conforming to the regulations
of the Occupational Safety and Health Administration of
the Department of Labor in 29
CFR 1910.1030. This exception includes medical equipment
intended for use, cleaning, or refurbishment, such as reusable
surgical equipment, or equipment used for testing where
the components within which the equipment is contained essentially
function as packaging. This exception does not apply to
medical equipment being transported for disposal.
(8)
A material, including waste, that previously contained an
infectious substance that has been treated by steam sterilization,
chemical disinfection, or other appropriate method, so it
no longer meets the definition of an infectious substance.
(9)
A living person.
(10)
Any waste or recyclable material, other than regulated medical
waste, including—
(i)
Garbage and trash derived from hotels, motels, and households,
including but not limited to single and multiple residences;
(ii)
Sanitary waste or sewage;
(iii)
Sewage sludge or compost;
(iv)
Animal waste generated in animal husbandry or food production;
or Medical waste generated from households and transported
in accordance with applicable state, local, or tribal
requirements.
(11)
Corpses, remains, and anatomical parts intended for interment,
cremation, or medical research at a college, hospital, or
laboratory.
(12)
Forensic material transported on behalf of a US Government,
state, local or Indian tribal government agency, except
that—
(i)
Forensic material known or suspected to contain a Risk
Group 2 or 3 infectious substance must be shipped in a
packaging conforming to the provisions of §
173.24.
(ii)
Forensic material known or suspected to contain a Risk
Group 4 infectious substance or an infectious substance
listed as a select agent in 42
CFR Part 72 must be transported in packaging capable
of meeting the test standards in §
178.609 of this subchapter. The secondary packaging
must be marked with a BIOHAZARD symbol conforming to specifications
in 29
CFR 1910.1030(g)(1)(i). An itemized list of contents
must be enclosed between the secondary packaging and the
outer packaging.
(13)
Environmental microbiological samples, such as a sample
of dust from a ventilation system or mold from a wallboard,
collected to evaluate occupational and residential exposure
risks.
(14)
Agricultural products and food as defined in the Federal
Food, Drug, and Cosmetics Act." 49
CFR 173.134 (10-1-2004 Edition)
US
DOT FINAL RULE (Effective Oct.
1, 2006) - "Exceptions The following
are not subject to the requirements of this subcha | |
