Regulatory Definitions

Basic Packaging Definitions

Other Useful Definitions

 

Defining your shipment category

 

 

INNER PACKAGING
US DOT
IATA

"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 (10-1-2010 Edition)

"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 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.

 

 

PRIMARY CONTAINER
US DOT
US POSTAL

"Inner receptacle means a receptacle which requires an outer packaging in order to perform its containment function. The inner receptacle may be an inner packaging of a combination packaging or the inner receptacle of a composite packaging." 49 CFR 171.8 (10-1-2010 Edition)

 

"Primary receptacle is the container (e.g., tube, vial, bottle) that holds the hazardous material." DMM Issue (6-5-2008) 601.10.1

 

 

SECONDARY CONTAINER
US POSTAL

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 (6-5-2008) 601.10.1

 

OUTER PACKAGING
US DOT
IATA
US Postal

"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 (10-1-2010 Edition)

 

"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 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 (6-5-2008) 601.10.1

 

 

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COMBINATION PACKAGING
US DOT
IATA

"Combination packaging means a combination of packaging, for transport purposes, consisting of one or more inner packagings secured in a non-bulk outer packaging. It does not include a composite packaging."

49 CFR 171.8 (10-1-2010 Edition)

"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 Appendix A

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SIFTPROOF PACKAGING
US DOT
IATA

"Siftproof packaging means a packaging impermeable to dry contents, including fine solid material produced during transportation." 49 CFR 171.8 (10-1-2010 Edition)

"Packagings impermeable to dry contents including fine solid material produced during transport." IATA Appendix A

 

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OVERPACK
US DOT
IATA

"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 (10-1-2010 Edition)

"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 Appendix A

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REUSED PACKAGINGS
IATA

"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 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 2.8.3.2

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PACKAGING GROUP
US DOT
IATA

"Packing 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 (10-1-2010 Edition)

"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 Appendix A

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PROPER SHIPPING NAME
US DOT
IATA

"Proper shipping name means the name of the hazardous material shown in Roman print (not italics) in § 172.101 of this subchapter." 49 CFR 171.8 (10-1-2010 Edition)

"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 Appendix A

 

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INFECTIOUS SUBSTANCE/BIOLOGICAL SUBSTANCE CATEGORY A
US DOT

"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." 49 CFR 173.134 (10-1-2010 Edition)

IATA

3.6.2.1.1 "Infectious substsances 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."

 

3.6.2.2.1 "Infectious substances must be classified in Division 6.2 and assigned to UN 2814, UN 2900, UN 3291, or UN3373, as appropriate."

3.6.2.2.2 Infectious substances are divided into the following categories.

3.6.2.2.2.1 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.

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 following 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 following table, the microorganisms written in italics are bacteria, mycoplasma, rickettsia or fungi.

3.6.2.2.2.2 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 Biological substance Category B.

Exemptions:

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.

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.

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.

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.

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.

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.

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.

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.

US POSTAL
"Infectious substance means a material known or reasonably expected to contain a pathogen. A pathogen is a microorganism that can cause disease in humans or animals. Examples of pathogens include bacteria, viruses, fungi, and other infectious agents. An infectious substance must be assigned to one of the following two categories:

1. Category A: An infectious substance transported in a form capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposure occurs. Category A infectious substances are not mailable. A Category A infectious substance is assigned the identification number UN 2814 or UN 2900, 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.

2. Category B (see next section)" DMM Issue (6-5-2008) 601.10.17.2

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DIAGNOSTIC SPECIMEN/BIOLOGICAL SUBSTANCE CATEGORY B
US DOT

"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." 49 CFR 173.134 (10-1-2010 Edition)

IATA
"3.6.2.2.2.2 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 Biological substance Category B. " IATA 3.6.2.2.2.2
US POSTAL
"Category B: An infectious substance that does not meet the criteria for inclusion in Category A. A mailpiece known or suspected to contain a Category B infectious substance must bear the proper shipping name "Biological substance, Category B" on the address side of the mailpiece and must be assigned to and marked with identification number UN 3373 or, for regulated medical waste and sharps medical waste, identification number UN 3291." DMM Issue (6-5-2008) 601.10.17.2

 

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EXEMPT HUMAN SPECIMEN OR EXEMPT ANIMAL SPECIMEN

US DOT

"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." 49 CFR 173.134(b)(11) (10-1-2010 Edition)

IATA

3.6.2.2.3 Exemptions

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.

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.

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.

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.

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.

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."

US POSTAL
Exempt human or animal specimen means a human or animal sample (including, but not limited to, secreta, excreta, blood and its components, tissue and tissue fluids, and body parts) transported for routine testing not related to the diagnosis of an infectious disease. Typically, exempt human specimens are specimens for which there is a low probability that the sample is infectious, such as specimens for drug or alcohol testing; cholesterol testing; blood glucose level testing; prostate-specific antigens (PSA) testing; testing to monitor heart, kidney, or liver function; pregnancy testing; and testing for diagnosis of noninfectious diseases such as cancer biopsies. Exempt human or animal specimens are not subject to regulation as hazardous materials but must be packaged according to 10.17.9.

DMM Issue (6-5-2008) 601.10.17.2

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BIOLOGICAL PRODUCTS
US DOT

"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." 49 CFR 173.134 (10-1-2010 Edition)

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 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 or arsphenamine or derivative of arsphenamine (or any other trivalent arsenic compound) intended to prevent, treat, or cure a disease or condition of humans 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, mark these mailpieces with identification number UN 3373 when they contain a biological product known or reasonably expected to contain a pathogen that meets the definition of a Category B infectious substance." DMM Issue (6-5-2008) 601.10.17.2

 

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USED HEALTH CARE PRODUCTS
US DOT
IATA
US Postal

"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 patient 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 (10-1-2010 Edition)

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 transport.." DMM Issue (6-5-2008) 601.10.17.2

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CULTURES
US DOT
IATA
US Postal

"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." 49 CFR 173.134 (10-1-2010 Edition)

"Cultures are the result of a process by which pathogens are intentionally propagated. This definition does not include patient specimens as defined in 3.6.2.1.4." IATA 3.6.2.1.3. "Cultures are infectious substances that result from a process by which pathogens are intentionally propagated. This definition does not include a human or animal patient specimen as defined in 10.17.2e." DMM Issue (6-5-2008) 601.10.17.2

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PATIENT SPECIMEN
US DOT
IATA
US Postal

"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)." 49 CFR 173.134 (10-1-2010 Edition)

"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 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 3.6.2.7.

"Patient specimen means material that is collected directly from humans or animals and transported for purposes such as diagnosis and research. Patient specimens include excreta, secreta, blood and its components, tissue and tissue swabs, body parts, and specimens in transport media (such as transwabs, culture media, and blood culture bottles). " DMM Issue (6-5-2008) 601.10.17.2

 

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GENETICALLY MODIFIED MICROORGANISMS AND ORGANISMS
IATA

"Genetically modified microorganisms not meeting the definition of an infectious substance must be classified according to Subsection 3.9." IATA 3.6.2.4.1

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."

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."

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."

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TOXINS
US DOT
IATA
US Postal

"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 (10-1-2010 Edition)

"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 3.6.1.1.1

"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)." 3.6.1.2

"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, UN 2900, or UN 3373, as appropriate. A toxin known or suspected to contain a Category A infectious substance is not mailable. A toxin known or suspected to contain a Category B infectious substance must be marked UN 3373 and packaged under 10.17.5. Toxins from plant, animal, or bacterial sources that do not contain an infectious substance, and are not contained in an infectious substance, may be considered for classification as Division 6.1 toxic substances under 10.16.." DMM Issue (6-5-2008) 601.10.17.2

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SHARPS
US DOT
US POSTAL

"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 (10-1-2010 Edition)

"Sharps medical waste, for USPS purposes, means a medical waste object that is capable of cutting or penetrating skin or packaging material and that is contaminated with a pathogen or may become contaminated with a pathogen derived from the medical treatment, diagnosis, immunization, or biomedical research of a human or animal. 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. Mark these mailpieces with identification number UN 3291." DMM Issue (8-7-2005) 601.10.17.2

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NONREGULATED MATERIALS/EXCEPTIONS
US DOT

Exceptions. The following are not subject to the requirements of this subchapter as Division 6.2 materials:

(1) A material that does not contain an infectious substance or that is unlikely to cause disease in humans or animals.

(2) Non-infectious biological materials from humans, animals, or plants. Examples include non-infectious cells, tissue cultures, blood or plasma from individuals not suspected of having an infectious disease, DNA, RNA or other non-infectious genetic elements.

(3) A material containing micro-organisms that are non-pathogenic to humans or animals.

(4) A material containing pathogens that have been neutralized or inactivated such that they no longer pose a health risk.

(5) A material with a low probability of containing an infectious substance, or where the concentration of the infectious substance is at a level naturally occurring in the environment so
it cannot cause disease when exposure to it occurs. Examples of these materials include: Foodstuffs; environmental samples, such as water or a sample of dust or mold; and substances that have been treated so that the pathogens have been neutralized or deactivated, such as a material treated by steam sterilization, chemical disinfection, or other appropriate method, so it no longer meets the definition of an infectious substance.

(6) A biological product, including an experimental or investigational product or component of a product, subject to Federal approval, permit, review, or licensing requirements, such as those required by the Food and Drug Administration of the U.S. Department of Health and Human Services or the U.S. Department of Agriculture.

(7) Blood collected for the purpose of blood transfusion or the preparation of blood products; blood products; plasma; plasma derivatives; blood components; tissues or organs intended for use in transplant operations; and human cell, tissues, and cellular and tissue-based products regulated under authority of the Public Health Service Act (42 U.S.C. 264–272) and/or the Food, Drug, and Cosmetic Act (21 U.S.C. 332 et seq.).

(8) Blood, blood plasma, and blood components collected for the purpose of blood transfusion or the preparation of blood products and sent for testing as part of the collection process, except where the person collecting the blood has reason to believe it contains an infectious substance, in which case the test sample must be shipped as a Category A or Category B infectious substance in accordance with § 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.

(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) Household waste as defined in § 171.8, when transported in accordance with applicable state, local, or tribal requirements.

(ii) Sanitary waste or sewage;

(iii) Sewage sludge or compost;

(iv) Animal waste generated in animal husbandry or food production; or

(v) Medical waste generated from households and transported in accordance with applicable state, local, or tribal requirements.

(14) Corpses, remains, and anatomical parts intended for interment, cremation, or medical research at a college, hospital, or laboratory.

(15) Forensic material transported on behalf of a U.S. Government, state, local or Indian tribal government agency, except that—

(i) Forensic material known or suspected to contain a Category B infectious substance must be shipped in a packaging conforming to the provisions
of § 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 asdefined in the Federal Food, Drug, and Cosmetics Act (21 U.S.C. 332 et seq.).

49 CFR 173.134 (10-1-2010 Edition)

IATA

3.6.2.2.3 Exemptions

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.

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.

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.

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.

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.

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."

US POSTAL

The following materials are not subject to regulation as Division 6.2 hazardous materials and are mailable when the packaging requirements in 10.17.8 are met:

a. 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. A biological product known or suspected to contain a Category B infectious substance must be marked UN 3373 and packaged under 10.17.4. A biological product known or suspected to contain a Category A infectious substance is not mailable.

b. 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 the Public Health Service Act (42 U.S.C. 264-272) or the Food, Drug, and Cosmetic Act (21 U.S.C. 332 et seq.).

c. Blood, blood plasma, and blood components collected for the purpose of blood transfusion or the preparation of blood products and sent for testing as part of the collection process, except where the person collecting the blood has reason to believe it contains a Category B infectious substance, in which case the test sample must be shipped as a Category B infectious substance. Materials known or suspected to contain a Category A infectious substance are not mailable.

d. Dried blood spots, collected by applying a drop of blood to absorbent material, or dried specimens for fecal occult blood detection. (These materials are not classified as exempt human or animal specimens.)

e. Forensic material containing a biological material, such as tissue, body fluid, excreta, or secreta, not expected to contain a Category A or Category B infectious substance and transported on behalf of a U.S. Government agency or a state, local, or Indian tribal government agency. A forensic material known or suspected to contain a Category B infectious substance must be shipped as a Category B infectious substance. A forensic material known or suspected to contain a Category A infectious substance is not mailable.Packaging—General

 

All materials mailable under the provisions in 10.17 must be properly packaged. Exhibit 10.17.3 lists the specific reference in 10.17 under which each type of mailable material must be packaged. DMM Issue (6-5-2008) 601.10.17.3

 

Back to Other Useful Definitions

 

References:

IATA Dangerous Goods Regulations 52th Edition, Effective 1 January - 31 December, 2011

Code of Federal Regulations, 49CFR Parts 100 to 185, revised as of October 1, 2010.