Domestic Mail
DMM REVISION
New Mailing Standards for Division 6.2 Infectious Substances
Effective November 1, 2006, we are revising the Mailing
Standards of the United States Postal Service, Domestic
Mail Manual (DMM®) to change the mailing standards and
packaging requirements for Division 6.2 infectious substances. The new standards are based on World Health
Organization, Department of Transportation, and International Civil Aviation Organization regulations, and prohibit
Category A infectious substances in the mail. Category A
includes infectious substances transported in a form capable of causing permanent disability or life-threatening or
fatal disease in otherwise healthy people or animals if
exposure occurs.
Our new standards:
• Change the classification system from the current
four-tiered risk group classification system to a two-
tiered system. Infectious substances are now classified as "Category A" and "Category B," depending on
the type of substance. Category A substances are
nonmailable.
• Replace the shipping name "Diagnostic Specimen"
with "Biological substance, Category B."
• Adopt new packaging requirements for Category B
infectious substances.
These changes will help ensure safety in handling and
transporting mailable infectious substances, and will also
facilitate domestic and international transportation by aligning our mailing standards with the current international
standards for the transport of hazardous materials.
In addition to these changes, we updated Tag 44, Sack
Contents Warning, for use on sacks and tubs containing
Category B infectious substances. Revised Tag 44 is dated
September 2006 and displays the proper shipping name
"Biological substance, Category B" and identification number UN 3373. Tag 44 must be attached to a sack or tub that
contains multiple mailpieces.
Mailing Standards of the United States Postal
Service, Domestic Mail Manual (DMM)
* * * * *
600 Basic Standards for All Mailing Services
601 Mailability
* * * * *
10.0 Hazardous Materials
* * * * *
10.17 Infectious Substances (Hazard Class 6,
Division 6.2)
10.17.1 General
[Revise the first and last sentences in 10.17.1 as follows:]
Division 6.2 materials include infectious substances, biological products, regulated medical waste, sharps medical
waste, used health care products, and forensic materials.
***Unless otherwise noted, all mailable Division 6.2 materials must meet the mail preparation requirements for air
transportation.
10.17.2 Definitions
* * * * *
[Revise item a as follows:]
a. 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: 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.
[Revise item b as follows:]
b. 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.
[Revise item c as follows:]
c. 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.
[Revise item d as follows:]
d. 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 regulations as hazardous materials but must be packaged
according to 10.17.10.
[Revise item e as follows:]
e. 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).
[Revise item f as follows:]
f. Regulated medical waste, for USPS purposes,
means a soft waste material (other than a sharp)
derived from the medical treatment, diagnosis,
immunization, or biomedical research of a human or
animal. Soft medical waste includes items such as
used rubber gloves, swabs, gauze, tongue depressors, and other similar material. Mark these mailpieces with identification number UN 3291.
[Delete Exhibit 10.17.2f, Risk Group Criteria. Revise item g
as follows:]
g. 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.
[Revise the last part of item h as follows:]
h.) ***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.
[Delete the last sentence in item i. Revise the last part of
the new last sentence as follows:]
i.) ***to remove or mitigate the infectious hazard prior to transport.
10.17.3 Nonregulated Materials
[Revise 10.17.3 as follows:]
The following materials are not subject to regulation as
Division 6.2 hazardous materials and are mailable when
the packaging requirements in 10.17.9 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
10.17.5. 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.
* * * * *
[Revise Exhibit 10.17.4 as follows:]
Exhibit 10.17.4 Packaging Standards for Division 6.2 Infectious Substances
Material Being Mailed
|
Packaging Standards
|
Nonregulated
|
Category A
|
Category B
|
Blood for Transfusion
|
10.17.9
|
nm
|
10.17.5
|
Biological Product
|
10.17.9
|
nm
|
10.17.5
|
Culture or Stock
|
10.17.9
|
nm
|
10.17.5
|
Patient Specimen
|
n/a
|
nm
|
10.17.5
|
Exempt Human or Animal Specimen
|
10.17.10
|
n/a
|
n/a
|
Forensic Material
|
10.17.9
|
nm
|
10.17.5
|
Regulated Medical Waste
|
10.17.6
|
nm
|
10.17.6
|
Sharps Waste
|
10.17.6
|
nm
|
10.17.6
|
Toxin *
|
10.16.4
|
nm
|
10.17.5
|
Treated Medical Waste
|
10.17.9
|
n/a
|
n/a
|
Used Health Care Product
|
10.17.7
|
nm
|
10.17.7
|
nm = Not mailable. n/a = Not applicable.
|
* 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 classified as Division 6.2; described as an infectious substance; and
assigned to UN 2814, UN 2900, or UN 3373, as appropriate. A Division 6.1 toxin that can qualify as an ORM-D material is
permitted when packaged under 10.16.3 or 10.16.4.
[Revise title and text of 10.17.5 as follows:]
10.17.5 Packaging Category B Infectious Substances
A material that is classified as a Category B infectious substance and that meets the definition in 10.17.2a2 must be
triple-packaged, meeting the packaging requirements in
49 CFR 173.199, and sent as First-Class Mail, Priority Mail,
or Express Mail. Each primary receptacle containing a liquid must be leakproof and surrounded by absorbent material sufficient to protect the primary receptacle and absorb
the total amount of liquid should the primary receptacle leak
or break. Each primary receptacle containing a solid must
be siftproof. Secondary containers for liquids must be leakproof. Secondary containers for solids must be siftproof.
The primary and secondary packaging must be enclosed in
a rigid outer shipping container. A single primary receptacle
must not contain more than 1 liter (34 ounces) of a liquid
specimen or 4 kg (8.8 pounds) of a solid specimen. Two or
more primary receptacles whose combined volume does
not exceed 4 liters (1 gallon) for liquids or 4 kg (8.8 pounds)
for solids may be enclosed in a single secondary container.
In addition:
a. The secondary container must be marked with
the international biohazard symbol shown in
Exhibit 10.17.6c2.
b. The primary receptacle or secondary packaging must
be capable of withstanding, without leakage, an internal pressure producing a pressure differential of not
less than 95 kPa (0.95 bar, 14 psi) in the range of
-40° C to 55° C (-40° F to 130° F).
c. All mailpieces sent under 10.17.5 must be marked on
the address side with the shipping name "Biological
substance, Category B" and "UN 3373" as outlined in
49 CFR 173.199 (a)(5). Regulated medical waste
and sharps medical waste as defined in 10.17.2f and
10.17.2g must be marked UN 3291. See 10.17.6.
d. Orientation arrows are not required on these mailpieces but may be used.
e. The outer packaging must show the name and telephone number of a person who is knowledgeable
about the material shipped and has comprehensive
emergency response and incident mitigation information, or of someone who has immediate access to the
person with such knowledge and information.
[Delete 10.17.6. Renumber current 10.17.7 through
10.17.10 as new 10.17.6 through 10.17.9.]
10.17.6 Sharps Waste and Other Mailable Regulated
Medical Waste
[Revise the introductory text in renumbered 10.17.6 as
follows:]
Regulated medical waste and sharps medical waste known
or suspected to contain a Category A infectious substance
are not mailable. Regulated medical waste and sharps
medical waste as defined in 10.17.2f and 10.17.2g, and
containing materials classified as Category B infectious
substances, must be marked UN 3291 and are permitted
for mailing only using merchandise return service (see
507.10.0) with First-Class Mail or Priority Mail service, subject to the following requirements:
* * * * *
[Revise item b as follows:]
b. Packaging. Regulated medical waste and sharps
medical waste that also meets the definition of a
Category A infectious substance are not mailable. A
medical waste material treated by steam sterilization,
chemical disinfections, or other appropriate method
so that it no longer contains a Category A or
Category B infectious substance must be packaged
under 10.17.9. The packaging for regulated medical
waste and sharps medical waste containing or
suspected of containing a Category B infectious substance is subject to these standards:
* * * * *
10.17.7 Packaging Used Health Care Products
[Revise the introductory text in renumbered 10.17.7 as
follows:]
A used health care product known or reasonably suspected
to contain a Category A material is not mailable. A used
health care product not suspected to contain an infectious
material, or that is known or suspected to contain a
Category B infectious substance, and is being returned to
the manufacturer or manufacturer's designee is mailable as
First-Class Mail, Priority Mail, or Express Mail subject to the
following packaging requirements:
* * * * *
[Revise title and introductory text in renumbered 10.17.8 as
follows:]
10.17.8 Packaging Forensic Material
Forensic material containing a biological material, such as
tissue, body fluid, excreta, or secreta, and sent on behalf of
a U.S. government agency or a state, local, or Indian tribal
government agency must be packaged under 10.17.9
when it is not known or suspected to contain a Category A
or Category B infectious substance. Forensic material
known or suspected to contain a Category A infectious substance is not mailable. Forensic material known or suspected to contain a Category B infectious substance as
identified in 10.17.5 is mailable as First-Class Mail, Priority
Mail, or Express Mail when triple-packaged in a primary
receptacle, secondary container, and a rigid outer shipping
container as follows:
* * * * *
[Revise title and text in renumbered 10.17.9 as follows:]
10.17.9 Packaging Nonregulated Materials
Nonregulated materials as defined in 10.17.3 are not subject to regulation as hazardous materials but must be properly packaged when presented for mailing. Regulated
medical waste, sharps medical waste, and used health
care products must be packaged and mailed under 10.17.6
and 10.17.7. Exempt human and animal specimens must
be packaged under 10.17.10. Nonregulated materials are
mailable as First-Class Mail, Priority Mail, Express Mail, or
Package Services mail. Such materials must be held within
a securely sealed primary receptacle. The primary receptacle must be surrounded by sufficient absorbent material
(for liquids) and cushioning material to protect the primary
receptacle from breakage. The absorbent material must be
capable of taking up the entire liquid contents of the primary
receptacle in case of leakage. Either the primary receptacle
or the inner packaging must be marked with the international biohazard symbol shown in Exhibit 10.17.6c2. The primary receptacle and the absorbent and cushioning material
must be snugly enclosed in a rigid outer shipping container
that is securely sealed. A shipping paper and a content
marking on the outer shipping container are not required.
Nonregulated material specimens and biological products
are subject to the following packaging standards:
a. Liquid Patient Specimens and Biological Products.
Mailers must package a liquid nonregulated patient
specimen, a forensic specimen, or a biological product (such as polio vaccine) as follows:
1. Not exceeding 50 ml. A patient specimen or biological product consisting of 50 ml or less per
mailpiece must be packaged in a securely sealed
primary receptacle. Two or more primary receptacles whose combined volume does not exceed
50 ml may be enclosed within a single mailpiece.
Sufficient absorbent material and cushioning
material to withstand shock and pressure changes
must surround the primary receptacle(s), or be
otherwise configured to take up the entire liquid
contents in case of leakage. The primary receptacle(s) and the absorbent cushioning must be
enclosed in a secondary container with a leakproof barrier that can prevent failure of the secondary container if the primary receptacle(s) should
leak during transport. The secondary container
must be securely sealed, and it may serve as the
outer shipping container if it has sufficient strength
to withstand ordinary postal processing. The secondary container must be marked with the
international biohazard symbol shown in
Exhibit 10.17.6c2, except when the secondary
container also serves as the outer shipping container. In that case, the biohazard symbol must
appear on the inner packaging or on the primary
container. A shipping paper and a content marking
on the outer shipping container are not required.
2. Exceeding 50 ml. A liquid patient specimen, forensic material, or biological product that exceeds
50 ml must be packaged in a securely sealed primary receptacle. A single primary receptacle must
not contain more than 500 ml of specimen. Two or
more primary receptacles whose combined volume does not exceed 500 ml may be enclosed in
a single secondary container. Sufficient absorbent
material and cushioning material to withstand
shock and pressure changes must surround the
primary receptacle(s), or be otherwise configured
to take up the entire liquid contents in case of
leakage. The primary receptacle(s) and the absorbent cushioning must be enclosed in a secondary
container with a leakproof barrier that can prevent
failure of the secondary container if the primary
receptacle(s) should leak during transport. The
secondary container cannot serve as the outer
shipping container. The secondary container must
be marked with the international biohazard symbol shown in Exhibit 10.17.6c2. The secondary
container must be securely and snugly enclosed
in a fiberboard box or container of equivalent
strength that serves as the outer shipping container. A shipping paper and a content marking on the
outer shipping container are not required.
b. Solid (or Dry) Specimen. A solid or dry specimen,
such as a saliva swab, blood spot, fecal smear, culture or stock, or forensic material, must be completely dried before packaging in a mailing container or
envelope. Cushioning material to withstand shock
and pressure changes is required only if the dry
specimen is placed in a breakable primary receptacle. When required, the cushioning material must
surround the primary receptacle. The primary receptacle (and cushioning material, if required) must be
enclosed in a secondary container with a siftproof
barrier that can prevent failure of the secondary container if the primary receptacle breaks during shipment. The secondary container must be securely
sealed, and it may serve as the outer shipping container if it has sufficient strength to withstand ordinary
postal processing. The secondary container must be
marked with the international biohazard symbol
shown in Exhibit 10.17.6c2, except when the secondary container also serves as the outer shipping container. In that case, the biohazard symbol must
appear either on the inner packaging or on the primary container receptacle. A shipping paper and a content marking on the outer shipping container are not
required.
[Add new 10.17.10 as follows:]
10.17.10 Packaging Exempt Human or Animal
Specimens
Exempt human or animal specimens as defined in 10.17.2d
are not subject to regulation as hazardous materials but
when presented for mailing must be triple-packaged in
leakproof (for liquids) or siftproof (for solids) primary receptacles. Sufficient cushioning and absorbent materials must
surround each primary receptacle containing liquid. Secondary containers for liquids must be leakproof. Secondary
containers for solids must be siftproof. The primary and
secondary packaging must be enclosed in a rigid outer
shipping container. A single primary receptacle must not
contain more than 500 ml of a liquid specimen or
500 grams of a solid specimen. Two or more primary
receptacles whose combined volume does not exceed
500 ml (for liquids) or 500 grams (for solids) may be enclosed in a single secondary container. The secondary container cannot serve as the outer shipping container. The
secondary container must be marked with the international
biohazard symbol shown in Exhibit 10.17.6c2. The secondary container must be securely and snugly enclosed in a
fiberboard box or container of equivalent strength that
serves as the outer shipping container. A shipping paper is
not required. The outer shipping container must be marked
on the address side with the words "Exempt human specimen" or "Exempt animal specimen," as appropriate. In
addition, at least one surface of the outer packaging must
have a minimum dimension of 3.9 inches x 3.9 inches (100
mm x 100 mm). Exempt human and animal specimens are
mailable as First-Class Mail, Priority Mail, Express Mail, or
Package Services mail.
* * * * *
We will incorporate this revision into the November 9,
2006, update of the online DMM available on Postal
Explorer® at http://pe.usps.com and into the next printed
edition of the DMM.
— Mailing Standards,
Pricing and Classification, 11-9-06
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