FR Doc E6-18062
[Federal Register: November 1, 2006 (Volume 71, Number 211)]
[Rules and Regulations]               
[Page 64121-64125]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01no06-6]                         

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POSTAL SERVICE

39 CFR Part 111

 
New Mailing Standards for Division 6.2 Infectious Substances

AGENCY: Postal Service.

ACTION: Interim rule with request for comments.

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SUMMARY: The Postal Service is revising its mailing standards and 
packaging requirements for Division 6.2 infectious substances based on 
the criteria published by the World Health Organization. Our revised 
standards adopt many of the changes the Department of Transportation 
made to its regulations for the shipment and packaging of hazardous 
materials. We also harmonize our standards with the World Health 
Organization Guidance on Regulations for the Transport of Infectious 
Substances and the International Civil Aviation Organization Technical 
Instructions for the Safe Transport of Dangerous Goods by Air. In 
addition, we prohibit Category A infectious substances in the mail.

DATES: These changes are effective November 1, 2006. We will accept 
your comments on or before December 1, 2006.

ADDRESSES: Mail or deliver written comments to the Manager, Mailing 
Standards, U.S. Postal Service, 475 L'Enfant Plaza, SW., Room 3436, 
Washington, DC 20260-3436. You may inspect and photocopy all written 
comments at USPS Headquarters Library, 475 L'Enfant Plaza, SW., 11th 
Floor N, Washington, DC between 9 a.m. and 4 p.m., Monday through 
Friday.

FOR FURTHER INFORMATION CONTACT: Bert Olsen, 202-268-7276.

SUPPLEMENTARY INFORMATION: The Postal Service is subject to the legal 
restrictions in Title 18 of United States Code 1716, which prohibits 
the mailing of ``all disease, germs, or scabs, and all other natural or 
artificial articles, compositions, or material which may kill or injure 
another, or injure the mails or other property'' if that material is 
outwardly or of its own force dangerous to life, health, or property. 
For legal and safety reasons, the mailing standards for hazardous 
materials in Mailing Standards of the United States Postal Service, 
Domestic Mail Manual (DMM) closely adhere to Department of 
Transportation (DOT) regulations in 49 CFR, and include additional 
limitations and prohibitions.
    On June 6, 2003, we published a final rule in the Federal Register 
(68 FR 33858) to revise the standards for mailing infectious 
substances. The revision harmonized our standards with many of the DOT 
regulations in effect at that time for the transportation of infectious 
substances. On June 2, 2006, DOT published new regulations (71 FR 
32244) to revise the transportation requirements for infectious 
substances and adopt new classification criteria, new exceptions, and 
new packaging and hazard communication requirements consistent with 
revised international standards.
    This interim rule harmonizes our mailing standards with the 
packaging category system for infectious substances developed by the 
World Health Organization (WHO) in 2005. Our revisions are largely 
consistent with DOT regulations for shipping and packaging hazardous 
materials and with the International Civil Aviation Organization (ICAO) 
Technical Instructions for the Safe Transport of Dangerous Goods by 
Air. We also 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 prohibition 
of Category A infectious substances is consistent with ICAO's 
recommendation that Category A substances not be carried by mail.
    Our interim rule:
     Revises 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.
     Identifies Category A infectious substances as 
nonmailable.
     Replaces the shipping name ``Diagnostic Specimen'' with 
``Biological substance, Category B.''
     Adopts packaging requirements for Category B infectious 
substances consistent with those in the DOT regulations, the WHO 
Guidance, and the ICAO Technical Instructions.
    These revisions to our mailing standards will provide a greater 
level of safety for handling and transporting mailable infectious 
substances. These changes will also facilitate domestic and 
international transportation by aligning our mailing standards with the 
current international standards for the transport of hazardous 
materials.
    We provide the new standards below. We will publish a final rule 
and may further revise the standards based on the comments we receive.
    Although we are exempt from the notice and comment requirements of 
the Administrative Procedure Act regarding proposed rulemaking (see 5 
U.S.C. 553(b), (c)), we invite public comments on the following 
revisions to Mailing Standards of the United States Postal Service, 
Domestic Mail Manual (DMM), incorporated by reference in the Code of 
Federal Regulations. See 39 CFR 111.1.

[[Page 64122]]

List of Subjects in 39 CFR Part 111

    Administrative practice and procedure, Postal Service.

0
Accordingly, 39 CFR part 111 is amended as follows:

PART 111--[AMENDED]

0
1. The authority citation for 39 CFR part 111 continues to read as 
follows:

    Authority: 5 U.S.C. 552(a); 39 U.S.C. 101, 401, 403, 404, 414, 
416, 3001-3011, 3201-3219, 3403-3406, 3621, 3626, 5001.

0
2. Revise the following sections of Mailing Standards of the United 
States Postal Service, Domestic Mail Manual (DMM), as follows:

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

    The terms used in the standards for Division 6.2 materials are 
defined as follows:
    [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.
    [Replace item d with new 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.
    [Replace item e with new 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).
    [Replace item f with new 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

[[Page 64123]]

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
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                                                                                Packaging standards
                      Material being mailed                      -----------------------------------------------
                                                                   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................................................              na              nm         10.17.5
Exempt Human or Animal Specimen.................................        10.17.10              na              na
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 10.7.5 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[deg]C to 55[deg]C (-40[deg]F to 130[deg]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 and renumber 10.17.7 through 10.17.10 as 10.17.6 
through 10.17.9.]

10.17.6 Sharps Waste and Other Mailable Regulated Medical Waste

    [Revise the introductory text as follows:]

[[Page 64124]]

    Regulated medical waste and sharps medical waste known or suspected 
to contain a Category A infectious substance is 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 is 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 is 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 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 the heading 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 the heading 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

[[Page 64125]]

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.
    [Insert 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.
* * * * *

Neva R. Watson,
Attorney, Legislative.
 [FR Doc. E6-18062 Filed 10-31-06; 8:45 am]

BILLING CODE 7710-12-P