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What is an Infectious Substance? .........................

What is a Risk Group? ...........................................

Why are Infectious Substances Regulated in

Transportation? .......................................................

Definitions ...............................................................

What Items Are Excepted from the Infectious

Substances Definition? ...........................................

Requirements for Transporting Infectious

Substances .............................................................

Requirements for Transporting Diagnostic

Specimens .............................................................

Requirements for Transporting Regulated

Medical Waste (RMW) ............................................

Used Health Care Products ....................................

Material of Trade .....................................................

Security Plans ........................................................

Incident Reporting .................................................

Reuse......................................................................

Placards ..................................................................

Where To Learn More ............................................

ii How to Transp

Copyrighted materials provided by Labelmasterand I

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 How to Transport Infectious Substances 

What is an Infectious Substance? (§ 173.134(a)(1))

An infectious substance (Division 6.2) is a material known to

contain or suspected of containing a pathogen that causes disease

in humans or animals. An infectious substance must be assigned

a risk group.

What is a Risk Group? (§ 173.134(a)(6))

A risk group (RG) is a number from 1 (low risk) to 4 (high risk)

that represents the rank of a microorganism’s ability to cause inju

through disease to an individual and community based on its

severity, mode and ease of transmission, and reversibility through

available agents and treatment.

Why Are Infectious Substances Regulated in

Transportation?

Congress requires the Secretary of Transportation to prescribe

regulations for the safe transportation of hazardous materials in

commerce to ensure public safety and minimize risks in

transportation. An infectious substance is a hazardous material. I

must meet the requirements of the Department of Transportation’s

Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180

before being offered for transportation by rail, water, air, or highway

port Infectious Substances

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2 How to Transpo

or analogous product used in the prevention, diagnosis,

treatment, or cure of diseases in humans or animals.

Cultures and Stocks - a material containing a RG 2, 3, or 

infectious substance prepared and maintained for growth 

storage.

Diagnostic Specimen - any human or animal material, oth

a RG 4 infectious substance, being transported for diagno

investigational purposes, but excluding live infected huma

animals.

Material of Trade (MOT) - a Division 6.2 material that is a

diagnostic specimen, biological produ

regulated medical waste, and carried 

motor vehicle for at least one of three

purposes described under the MOT d

in § 171.8. A RG 4 infectious substan

not be transported as a MOT.

Regulated Medical Waste (RMW) - a 

reusable material known to contain or

suspected of containing a RG 2 or 3

infectious substance and generated in the diagnosis, trea

or immunization of human beings or animals, research re

these activities, or the production or testing of biological p

Sharps - any object that is or may become contaminated 

pathogen through handling or during transportation that is

capable of cutting or penetrating skin or a packaging mate

Toxin - a Division 6.1 (poisonous) material from a plant, a

bacterial source that contains or is contained in a Division 

material.

Used Health Care Product - a medical, diagnostic, or res

device or piece of equipment, or a personal care product 

consumers, medical professionals, or pharmaceutical pro

that is contaminated with potentially infectious body fluid o

material. It does not meet the definition of a diagnostic sp

biological product, or RMW.

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z A material containing a RG 1 infectious substance.

z A material that contains no pathogen or in which the pathogen 

neutralized or inactivated.

z A biological product subject to federal approval, permit, or lice

z Blood collected for transfusion or testing or to make blood prod

prepared blood products, tissues or organs intend for transplan

operations, and human cell, tissue, and cell- and tissue-based 

under the authority of the Public Health Service Act or the Food

Act. If believed to contain an infectious substance, a sample o

transfusion, or to make a blood product, that is transported for 

must comply with the requirements in § 173.199.

z A diagnostic specimen or biological product transported by a p

or contract carrier in a motor vehicle used exclusively for these

materials. The vehicle may include properly packaged medica

research equipment and lab products.

z Laundry or medical equipment, except medical equipment

transported for disposal, that conforms to the regulations in

29 CFR 1910.1030.

z A living person.

z Any waste or recyclable material, other than RMW, that is:

6 garbage and trash from a residence, including households 

6 sanitary waste, sewage or sewage sludge or compost,

6 animal waste generated in husbandry or food production, o

6 medical waste generated from households and transported 

state, local, or tribal requirements.

z Corpses, remains, and anatomical parts intended for intermen

medical research.

z Forensic material transported on behalf of U.S. government, s

tribal requirements, except material known or suspected to con

substance that is:

6 a RG 2 or 3 infectious substance shipped in § 173.24 packa

ort Infectious Substances How to Transport Infectious Substances 

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 How to Transpo

ing the specification under 29 CFR 1910.1030(g

of contents between the secondary and outer pa

packaging.

z Environmental microbiological samples known or susp

non-infectious collected to evaluate occupational and r

risks.

z Agricultural products and food, as defined in the federa

Cosmetics Act.

Requirements for Transporting Infectious Subst

Division 6.2 Packaging

z A triple packaging that includes:

6 a watertight primary receptacle,

6 a watertight secondary packaging,

6 an outer packaging at least 100 mm (3.9 inches) in 

6 for a liquid, an absorbent material between the prim

secondary packaging,

6 an itemized list of contents between the secondary 

packagings,

6 a primary receptacle or secondary packaging capa

an internal pressure producing a pressure differen

95 kPa (0.95 bar, 14 psi), and

6 a primary receptacle or secondary packaging capa

withstanding temperatures ranging from -40o C to 

(-40o F to +131o F).

z Meets the test requirements in § 178.609

z Additional requirements:

6 Lyophilized (freeze dried) - primary receptacle is 

ampule or rubber-stopped glass vial fitted with a m

6 Liquid or solid infectious substances:

 Ambient or higher temperature: glass, meta

receptacle with a leakproof seal.

 Refrigerated or Frozen: ice or dry ice outsid

packaging or in an overpack with interior sup

secondary packaging.

©

4

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 How to Transport Infectious Substances 

metal vented vacuum insulated vessels or 

relief valves or similar devices in the vent l

prohibited);

6 fill and discharge openings protect against 

and

6 packaging design prevents release of liquid 

orientations.

z Live animals: transported under the terms and conditions 

(see 49 CFR Part 107, Subpart H).

z Body parts, organs, or whole bodies: packaging meets § 

(b), or § 173.197.

Required

Marking 6

z Hazardous material: 49 CFR Part 172, Subpart D.

z UN standard non-bulk packaging: § 178.503(f).

Labeling - INFECTIOUS SUBSTANCE label - § 172.432.

Shipping Paper - 49 CFR Part 172, Subpart C.

Emergency Response Information - 49 CFR Part 172, Subp

Formal Training and Recordkeeping - 49 CFR Part 172, Su

Requirements for Transporting Diagnostic Specim

Diagnostic Specimen Packaging

z Primary receptacle:

6 packed so it cannot break, be punctured, or leak into 

packaging.

6 fragile primary receptacles in a single secondary pac

individually wrapped or separated to prevent contact

6 if containing a liquid -

 leakproof with a capacity of 500 mL (16.9 ounce

 absorbent material sufficient to absorb all the liq

primary and secondary packaging.

6 if containing a solid -

 sift proof primary receptacle with a capacity of 5

or less.

z Secondary packaging:

6 secured in outer packaging with cushioning material 

protective properties and that of the outer packaging 

leak.

6 if containing a liquid -

ort Infectious Substances

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6 How to Transpo

Requirements for Transporting Regulated Medi

Waste (RMW) (§§ 173.134(c) and (d), and 173.197

RMW Packaging - Non-bulk

z Non-specification (§ 173.134(c))

6 Other than a waste culture or stock:

 rigid,

 meets §§ 173.24, 173.24a, and 29 CFR 1910

 offered for transportation by private or contra

6 RG 2 or 3 infectious substance waste culture or s

 rigid,

 meets §§ 173.24, 173.24a, and 29 CFR 191

 offered for transportation by private or contract 

dedicated RMW vehicle, and

 can include medical or clinical equipment and 

properly packaged and secured.

z UN Standard (§ 173.197(b))

6 rigid,

6 meets Packing Group (PG) II performance require

49 CFR Part 178, and

6 puncture-resistant for sharps and those with fluid 

g 

 leakproof.

z Outer packaging:

6 the completed package is capable of successfully 

in § 178.603 from a height of at least 1.2 meters (

6 may not exceed 4 L (1 gallon) for liquids, and

6 may not exceed 4 kg (8.8 pounds) for solids.

Required

Marking - Hazardous material: “Diagnostic Specimen” on 

Formal Training and Recordkeeping - each person who o

diagnostic specimen for transportation must know about the 

§ 173.199.

Not required

Labeling (an INFECTIOUS SUBSTANCE label), Shipping 

Response Information.

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 How to Transport Infectious Substances 

 design, testing, and re-qualification requiremen

intermediate bulk containers under 49 CFR Par

Subpart O;

 rigid inner packagings for liquids;

 enough absorbent material in a location to abso

liquid present; and

 sharps packagings capable of retaining liquid.

Non-specification wheeled cart (Cart).

 solid one-piece body with a volume of 1,655 L (

less;

 metal, rigid plastic, or fiberglass with a fitted lid

 meets drop test in § 178.603 at the PG II perfor

 inner packaging placed and restrained in a way 

breakage.

6 Non-specification bulk outer packaging (BOP).

 metal or fiberglass with a volume of 3.5 cubic m

feet) to 45 cubic meters (1,590 cubic feet);

 fully welded or seamless bottom and side joints

 rigid and weatherproof top; and

 closure on each opening to prevent water from 

 leakproof in the upright position, and can conta

(79.2 gallons) with closures open;

 inner packagings placed in a way that minimize

 plastic film bags are separated by a rigid barrie

rigid inner packagings; and

 Division 6.1 and Class 7 chemotherapeutic was

cultures and stocks of RG 2 or 3 organisms, un

and sharps may be transported if separated as 

§ 173.197(d)(3)(v).

6 General requirements for Carts and BOPs:

 outer packagings have smooth, non-porous inte

of defects;

 used exclusively to transport RMW;

 disinfected before reuse;

 not permitted: Division 6.1 (toxic) or Class 7 (ra

unless it is chemotherapeutic waste, and untrea

and stocks;

 requires rigid non-bulk packaging that conforms 

§173.197(a): Division 6.1 and Class 7 chemoth

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8 How to Transpo

and tear-resistance tests (e.g., marked with “AST

and “ASTM D 1922.00a”),

 must pass closed inverted bag test, and

 each film bag may not weigh more than 10 kg (2

filled.

6 Liquid:

 rigid inner packaging meeting the requirements 

and

 each inner packaging may not contain more than 

(5 gallons).

6 Sharps:

 puncture-resistant container,

 capable of passing the drop test at the PG II per

level if larger than 76 L (20 gallons), and

 may be reused if:

 approved by the Food and Drug Administrat

 marked for reuse, and

 disinfected before reuse.

Required

Marking

z Hazardous material: 49 CFR Part 172, Subpart D.

z UN standard package:

6 Non-bulk: § 178.503.

6 Large: UN Recommendations, Chapter 6.6.

z Bulk Package:

6 BIOHAZARD symbol meeting the specification under

29 CFR 1910.1030(g)(1)(i), and applied as required i

Labeling - an INFECTIOUS SUBSTANCE label.

Shipping Paper - 49 CFR Part 172, Subpart C.

Emergency Response Information - 49 CFR Part 172, Subp

Formal Training and Recordkeeping - 49 CFR Part 172, Sub

Not required

Labeling - an INFECTIOUS SUBSTANCE label is not required 

§ 173.134(c) packaging with a BIOHAZARD marking.

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 How to Transport Infectious Substances 

transported as a used health care product.

Packaging

6 product is drained of liquid,

6 product is placed in a watertight primary container,

6 packaging is capable of retaining without puncture a

product that can cut or penetrate skin or packaging

material,

6 a watertight secondary container,

6 an outer packaging with sufficient cushioning materi

prevent movement of the secondary packaging, and

6 an itemized list of contents in between the secondar

and outer packaging.

Required

Marking - primary and secondary containers must be marked 

the BIOHAZARD symbol under 29 CFR 1910.1030(g)(1)(i).

Formal Training and Recordkeeping - each person who off

for transportation or transports a used health care product mu

know about the requirements of § 173.199.

Not required

Labeling - an INFECTIOUS SUBSTANCE label.

Emergency Response Information; Shipping Paper.

The product is excepted from all other HMR requirements wh

returned to the manufacturer or its designee, and packaged a

required under § 173.199(d).

ort Infectious Substances

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6 For liquids:

 leak-tight inner packaging,

 leak-tight outer packaging, and

 enough absorbent material to absorb the ent

of the inner packaging.

6 For sharps:

 rigid, and

 puncture- and leak-resistant inner packaging

 Outer packaging:

6 strong,

6 tight,

6 securely closed, and

6 secured against movement.

 Capacity limitations:

6 inner packagings with a gross mass or capacity o

 0.5 kg (1.1 pound) or less, or

 0.5 L (17 ounces) or less.

6 an outer packaging having a gross mass or capa

 4 kg (8.8 pounds) or less, or

 4 L (1 gallon) or less; or

6 a single inner packaging within a single outer pac

with a gross mass or capacity of:

 16 kg (35.2 pounds) or less, or

 16 L (4.2 gallons) or less.

For RMW

 Capacity limitations:

6 inner packagings with a gross mass or capacity o

 4 kg (8.8 pounds) or less, or

 4 L (1 gallon) or less.

6 a single inner packaging within a single outer pac

mass or capacity of:

 16 kg (35.2 pounds) or less, or

 16 L (4.2 gallons) or less.

10 How to Transpo

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 How to Transport Infectious Substances 

Not required

Shipping Paper, Emergency Response Information, Forma

Recordkeeping.

Security Plans (§§ 172.800 and 172.804)

Shippers and carriers of the following are required to develop 

implement a security plan:

z a highway route-controlled quantity of a

Class 7 (radioactive) material

in a motor vehicle, rail car, or freight

container;

z more than 25 kg (55 pounds) of a Division

1.1, 1.2, or 1.3 explosive in a motor vehicle,

rail car, or freight container;

z more than 1 L (1.06 quarts) per package of

a material poisonous by inhalation, Hazard

Zone A;

z a shipment of hazardous material in a bulk

packaging with a capacity of 13,248 L (3,500 gallons) 

liquids or gases, or more than 13.24 cubic meters (46

for solids;

z a shipment in non-bulk packagings with a gross weigh

(5,000 pounds) or more of one class of hazardous ma

required to be placarded under 49 CFR Part 172, Sub

z a select agent or toxin regulated by the Centers for D

Control and Prevention under 42 CFR Part 73; or,

z a quantity of material that requires a placard.

ort Infectious Substances

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Incident Reporting (§§ 171.15 and 171.16)

You must report any release of an infectious substance in

transportation to the Department of Transportation. See § 17

for telephonic report requirements and § 171.16 for written re

requirements.

Exception (§ 173.199(a)): For a diagnostic specimen, an

incident report is required only when a release occurs during

transportation by aircraft.

Reuse (§§ 173.28(f) and

177.843(d))

Containers and transport vehicles: 

infectious substance container or trans

vehicle must be cleaned before reuse 

any means that will neutralize the infec

tious substance the packaging previou

contained.

Exception: The secondary or outer

packaging do not need to be disinfected prior to reuse if the

primary receptacle did not leak. The transport vehicle does n

need to be disinfected unless a Division 6.2 material is releas

from its packaging.

Placards

No placards are required for Division 6.2 materials.

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