[Federal Register Volume 67, Number 244 (Thursday, December 19, 2002)]
[Proposed Rules]
[Pages 77726-77737]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-31990]



[[Page 77726]]

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POSTAL SERVICE

39 CFR Part 111


Hazardous Materials: Proposed Domestic Mail Manual Revisions for 
Division 6.2 Infectious Substances and Other Related Changes

AGENCY: Postal Service.

ACTION: Proposed rule.

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SUMMARY: The Postal Service is proposing to revise the mailing 
standards in Domestic Mail Manual (DMM) C023 related to the 
requirements and packaging standards for mailable types of Division 6.2 
infectious substances. These DMM revisions would adopt some of the 
regulatory and packaging changes for infectious substances that the U. 
S. Department of Transportation (DOT) made to Title 49 Code of Federal 
Regulations (49 CFR) in the Federal Register final rule published on 
August 14, 2002 (67 FR 53118) and the subsequent change published on 
August 27, 2002 (67 FR 54967). If the revisions proposed by the Postal 
Service were adopted, they would provide a greater level of safety for 
handling and transporting mailable infectious substances in the 
mailstream.
    The proposed changes would also facilitate domestic and 
international air transportation by aligning the changes with the 
current international standards for the transport of hazardous 
materials via air.
    Other minor changes and clarifications are proposed to the 
hazardous materials mailing standards in DMM C021, C023, C024, and F010 
to improve clarity and reduce misunderstanding; to ensure the packaging 
integrity of mailable hazardous materials during Postal Service 
handling; and to provide a greater level of safety for Postal Service 
employees and the public.

DATES: Comments must be received on or before January 21, 2003.

ADDRESSES: Mail or deliver written comments to the Manager, Mail 
Preparation and Standards, U.S. Postal Service, 1735 North Lynn Street, 
Room 3025, Arlington, VA 22209-6038. Written comments may be submitted 
via fax to 703-292-4058. Copies of all written comments will be 
available for inspection and photocopying between 9 a.m. and 4 p.m., 
Monday through Friday, at the Postal Service Headquarters Library, 475 
L'Enfant Plaza SW., Room 11800, Washington, DC 20260-1540.

FOR FURTHER INFORMATION CONTACT: Jane Stefaniak (703) 292-3548, Mail 
Preparation and Standards, United States Postal Service.

SUPPLEMENTARY INFORMATION: The carriage of U.S. mail by the United 
States Postal Service (Postal Service) is regulated by Title 39 Code of 
Federal Regulations (39 CFR). Unlike commercial carriers, the Postal 
Service is not subject to the Federal regulations of the U.S. 
Department of Transportation (DOT) in Title 49 Code of Federal 
Regulations (49 CFR). The Postal Service is, however, subject to the 
legal restrictions in Title 18 United States Code 1716 (18 U.S.C. 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 matter is outwardly or of its own force dangerous to 
life, health, or property. Accordingly, for legal and safety reasons, 
the mailing standards for hazardous materials in the Domestic Mail 
Manual (DMM) not only closely adhere to the DOT regulations in 49 CFR, 
but also include many additional limitations and prohibitions.
    In many instances, the Postal Service standards are more 
restrictive than the DOT requirements that apply to shipments being 
transported in domestic commerce. As an example, commercial shippers 
are permitted under the DOT regulations in 49 CFR to send certain types 
of flammable materials via air transportation. In contrast, the Postal 
Service prohibits the mailing of all flammable materials via air 
transportation.
    Under Postal Service mailing standards, most hazardous materials 
are nonmailable. With few exceptions, the Postal Service generally 
limits the mailing of hazardous materials to only those materials that 
can be reclassified as an ORM-D material under the DOT Federal 
regulations in 49 CFR 173.144 and that can be renamed with the proper 
shipping name of ``Consumer Commodity.'' Additionally, mailable 
hazardous materials must meet the Postal Service quantity and packaging 
requirements, which in many instances are more restrictive than the DOT 
requirements in 49 CFR. Of all regulated hazardous materials, ORM-D 
materials present the lowest level of risk during handling and 
transportation.
    Over the past few years, the Postal Service has encountered 
increasing difficulties with the commercial carriers who are contracted 
to provide air transportation services for the carriage of U.S. mail. 
Many carriers have refused to transport mailpieces containing mailable 
hazardous materials. In some instances, an air carrier has established 
a corporate policy not to carry hazardous materials. In other cases, an 
air carrier has refused to carry a specific type of hazardous material 
(e.g., diagnostic specimens) because Postal Service packaging 
standards, which met Federal standards, did not meet the international 
standards followed by the air carrier industry.
    To ensure an acceptable level of safety and to facilitate domestic 
and international transportation, the Postal Service is proposing to 
adopt some of the regulatory and packaging changes for Division 6.2 
infectious substances that DOT adopted as revisions to 49 CFR in the 
Federal Register (67 FR 53118 and 67 FR 54967). The DOT changes are 
consistent with the current international standards found in the 
Technical Instructions for the Safe Transport of Dangerous Goods 
published by the International Civil Aviation Organization (ICAO).
    It should also be noted that many of the DOT Federal regulations in 
49 CFR involve requirements for the transport of hazardous materials 
that have moderate, high, or very high risk levels and that are shipped 
in very large quantities (exceeding 70 pounds in weight). Such 
hazardous materials are not permitted in the U.S. mail due to the legal 
restrictions in 18 U.S.C. 1716, concerns for employee and public 
safety, and Postal Service size and weight limitations. Accordingly, 
the Postal Service proposes to adopt only the new DOT regulations for 
Division 6.2 infectious substances that apply to materials that can be 
safely handled in the U.S. mail. As an example, the Postal Service 
would not adopt the new DOT bulk packaging options for regulated 
medical waste because under DOT regulations in 49 CFR, a bulk packaging 
is defined as a receptacle that has a capacity greater than 450L (119 
gallons) for liquid materials or a net mass greater than 400 kg (882 
pounds) for solid materials. As established by law, the maximum size 
and weight limits per mailpiece are 70 pounds and 108 inches in 
combined length and girth (130 inches for Parcel Post). A bulk 
packaging receptacle as defined by DOT would be nonmailable in the U.S. 
mail because it would exceed the maximum size and weight limits for 
mailing, while also posing an unacceptable risk level during Postal 
Service transport and handling.
    In this proposed rule, the Postal Service proposes the adoption of 
the following changes to the mailing standards for Division 6.2 
infectious substances:

[[Page 77727]]

    [sbull] New classification criteria for Division 6.2 infectious 
substances based on the defining criteria developed by the World Health 
Organization (WHO) and consistent with the DOT Federal regulations in 
49 CFR for domestic transport and the ICAO technical instructions for 
international transport.
    [sbull] New DOT packaging requirements that are applicable to the 
mailable types of Division 6.2 materials and consistent with the ICAO 
technical instructions. For safety reasons, the proposed Postal Service 
volume limits may be lower than the DOT limits in some instances.
    [sbull] New DOT Federal requirements that regulate diagnostic 
specimens in Risk Group 2, 3, or 4 as hazardous materials.
    [sbull] Revisions and modifications in the new DOT Federal 
regulations related to the definitions of Division 6.2 materials and 
use of the biohazard symbol.
    In addition, the Postal Service is also proposing a few minor 
clarifications and changes to the hazardous materials standards and 
certain related standards in DMM C021, C023, C024, and F010. These 
proposed clarifications and changes would improve clarity in the 
standards and reduce misunderstanding. They would also improve 
packaging integrity for medical and sharps waste and provide a greater 
level of safety during handling for both Postal Service employees and 
the public. These proposed changes include:
    [sbull] Minor revisions to the text in DMM C021 to improve clarity.
    [sbull] Minor clarifications to the definitions in DMM C023.1.1 
including added text in the definition for ``air'' transportation 
requirements to note that the Postal Service does not guarantee air 
transportation service for any class of mail. Air transportation 
service is usually provided for First-Class Mail[hairsp][reg], Priority 
Mail[hairsp][reg], and Express Mail[hairsp][reg] destined to zones 5 
through 8, however, it is dependent on the ability of the Postal 
Service to procure an air carrier.
    [sbull] Standardization of the terminology used in DMM C023 for 
identifying the different components required for the proper packaging 
of mailable hazardous materials.
    [sbull] Expansion of the Registered Mail[hairsp][reg] service 
requirement in DMM C023.8.0 for use with mailable infectious substances 
to provide added security and safety during Postal Service handling. 
Currently only the infectious substances listed in 42 CFR 72.3(f) are 
required to be sent as Registered Mail. This proposal would require 
that all mailable Risk Group 4 infectious substances be sent as 
Registered Mail.
    [sbull] Expansion of the requirements in DMM C023.8.0 to establish 
that regulated medical waste would be subject to the same authorization 
requirements as sharps waste.
    [sbull] Clarifications and minor changes to the requirements in DMM 
C023.8.0 for sharps waste containers to enhance the accuracy of the 
regulations and reduce misunderstanding of the standards. In addition, 
the Postal Service proposes additional limitations for sharps waste 
containers to ensure packaging integrity during Postal Service handling 
and to provide a greater level of safety for Postal Service employees 
and the public.
    [sbull] Clarification of the required placement of the biohazard 
symbol in DMM C023.8.0 for mailable regulated and nonregulated Division 
6.2 materials that are permitted in the mail.
    [sbull] Standardization of the maximum weight limit in DMM C023 for 
several different types of mailable hazardous materials as 25 pounds or 
less. This change would affect nonflammable compressed gasses, matches, 
medical waste, sharps, and nonspillable wet batteries.
    [sbull] Reinstatement of former DMM C024.18.0 (DMM Issue 56) with 
revised text to clarify the mailability of odd-shaped items in paper 
envelopes and to support the restrictions for harmful matter in DMM 
C021.
    [sbull] Revisions to DMM F010 that would prohibit the use of the 
ancillary service endorsement ``Change Service Requested'' on Priority 
Mail, First-Class Mail, Standard Mail, and Package Services mail 
containing mailable perishable matter (including live animals) under 
DMM C022, hazardous materials under DMM C023, and restricted matter 
under DMM C024. Also, a revision to require a return or forwarding 
endorsement on Standard Mail containing mailable perishable matter, 
hazardous materials, or restricted matter.
    A phase-in period through April 30, 2003 is proposed for mailer 
implementation of the new packaging requirements for diagnostic 
specimen mailpieces using a business reply mail format and sharps waste 
mailpieces using a merchandise return service format. This time period 
will allow mailers to exhaust any existing packaging stock presently in 
circulation.
    The Postal Service believes that the adoption of the changes in 
this proposed rule would help to ensure an acceptable level of security 
and safety during Postal Service handling for the types and quantities 
of hazardous materials that are permitted in the U.S. mail.
    Although exempt from the notice and comment requirements of the 
Administrative Procedure Act [5 U.S.C. 553(b), (c)] regarding proposed 
rulemaking by 39 U.S.C. 410(a), the Postal Service invites comments on 
the following proposed revisions of the Domestic Mail Manual (DMM) 
incorporated by reference in the Code of Federal Regulations. See 39 
CFR part 111.

List of Subjects in 39 CFR Part 111

    Administrative practice and procedure, Postal Service.

PART 111--[AMENDED]

    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, 
3001-3011, 3201-3219, 3403-3406, 3621, 3626, 5001.

    2. Revise the following sections of the Domestic Mail Manual (DMM) 
as follows:

Domestic Mail Manual (DMM)

* * * * *

C Characteristics and Content

C000 General Information

* * * * *

C020 Restricted or Nonmailable Articles and Substances

C021 Articles and Substances Generally

* * * * *
2.0 NONMAILABLE ARTICLES AND SUBSTANCES--GENERAL

2.1 Basic Information

    [Delete the last two sentences of 2.1 and insert the following text 
to read as follows:]
    * * * The mailability standards that apply to perishable, 
hazardous, and restricted matter are detailed in C022, C023, and C024, 
respectively. Publication 52, Hazardous, Restricted, and Perishable 
Mail, contains additional clarification and further describes the 
conditions of preparation and packaging under which the USPS accepts 
for mailing potentially harmful matter that is otherwise nonmailable. 
Publication 52 also contains detailed information on the mailability of 
specific hazardous materials.
* * * * *
3.0 INJURIOUS AND HARMFUL ARTICLES

3.1 General

* * * * *
    [Revise item b to read as follows:]
    b. All poisonous animals, except scorpions mailed for medical 
research purposes or for the manufacture of

[[Page 77728]]

antivenom; all poisonous insects; all poisonous reptiles; and all types 
of snakes, turtles, and spiders.
* * * * *

3.2 Hazardous Materials

    [Revise the first sentence to read as follows:]
    Harmful matter also includes regulated hazardous materials as 
defined in C023 that are likely to harm USPS employees or to destroy, 
deface, or otherwise damage mail or postal equipment.* * *
4.0 MARKING
* * * * *

4.2 Addressing

    [Revise 4.2 to read as follows:]
    For any matter mailed under the provisions in C020, the recipient's 
name and address must be affixed or applied directly to the mailpiece 
using a material or method that is not water-soluble and not easily 
smeared or rubbed off. Except for diagnostic specimen mailpieces using 
a business reply mail format and nonregulated materials, a return 
address that includes the sender's name and address must appear on all 
matter mailed under C020. The return address, when required, must be 
applied using a material or method that is not water-soluble and not 
easily smeared or rubbed off.

4.3 Warning Label

    [Revise the last sentence in 4.3 to read as follows:]
    * * * See C023 for the warning label requirements that apply to the 
mailing of hazardous materials.
* * * * *

C023 Hazardous Materials

Summary
    [Revise the Summary to read as follows:]
    C023 describes the general standards, restrictions, and 
prohibitions that apply to the mailability of hazardous materials.
1.0 GENERAL

1.1 Definitions

* * * * *
    [Revise the last sentence in item a to read as follows:]
    a. * * * In international commerce, hazardous materials are known 
as dangerous goods.
    [At the end of item b, add a new sentence to read as follows:]
    b. * * * Almost all limited quantity materials are nonmailable.
    [At the end of item c, add a new sentence to read as follows:]
    c. * * * ORM-D materials having the proper shipping name of 
``consumer commodity'' are mailable subject to USPS quantity and 
packaging standards.
* * * * *
    [Revise items e and f to read as follows:]
    e. Air transportation requirements, for the purposes of C023 only, 
apply to all mailable hazardous materials sent at the First-Class Mail, 
Priority Mail, or Express Mail rates. All mailable hazardous materials 
sent at those rates must meet the requirements that apply to air 
transportation. Mailable hazardous materials sent at any of those rates 
may or may not be transported via air depending on the distance between 
the point of origination and the point of destination, and the ability 
of the USPS to obtain an air carrier between those points.
    f. Surface transportation requirements, for the purposes of C023 
only, apply to all mailable hazardous materials sent at the Standard 
Mail or Package Services rates. All mailable hazardous materials sent 
at the Standard Mail or Package Services rates must meet the 
requirements that apply to surface transportation.
* * * * *
    [Revise item h to read as follows:]
    h. 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 do not require the use of a secondary container.
    [Revise item i to read as follows:]
    i. 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.

1.2 U.S. Department of Transportation

    [Revise 1.2 to read as follows:]
    The U.S. Department of Transportation (DOT) regulates the surface 
and air carriage of hazardous materials within the United States via 
any means of transportation. The DOT regulations for the transport of 
hazardous materials are codified in Title 49, Code of Federal 
Regulations (49 CFR) 100-185. USPS mailing standards for hazardous 
materials generally adhere to 49 CFR, but also include many additional 
limitations and prohibitions.
    [Renumber 1.3 through 1.9 as 1.4 through 1.10 and insert new 1.3 to 
read as follows:]

1.3 USPS Standards

    The USPS standards generally restrict the mailing of hazardous 
materials to ORM-D materials with the proper shipping name of 
``consumer commodity'' that meet USPS quantity limitations and 
packaging requirements. The few non-ORM-D materials permitted to be 
mailed are subject to the standards in C023. Detailed information on 
the mailability of specific hazardous materials is contained in 
Publication 52, Hazardous, Restricted, and Perishable Mail.

1.4 Hazard Class

* * * * *
    [Renumber ``Exhibit 1.3 DOT Hazard Classes and Mailability 
Summary'' as ``Exhibit 1.4 DOT Hazard Classes and Mailability 
Summary.'']
* * * * *

1.6 Mailability Rulings

    [In the first sentence, change ``package'' to ``mailpiece.'']

1.7 Warning Labels

    [Change ``division 6.2 materials under 8.3'' and ``as required in 
1.7'' to ``Division 6.2 materials under 8.5'' and ``as required in 
1.8''.]

1.8 Package Markings

    [Delete the last sentence in 1.8 and insert two new sentences to 
read as follows:]
    * * * The designation ``ORM-D'' or ``ORM-D AIR'', as required, must 
be placed within a rectangle that is approximately 6.3 mm (\1/4\ inch) 
larger on each side than the designation. Mailable ORM-D materials sent 
as Standard Mail or Package Services must also be marked on the address 
side as ``Surface Only'' or ``Surface Mail Only.''

1.9 Shipping Papers

    [Revise 1.9 to read as follows:]
    A shipper's declaration for dangerous goods (i.e., shipping paper) 
prepared under 49 CFR 172.200 through 172.205 is required for certain 
types of hazardous materials when mailed. The shipping paper must be 
completed and signed in triplicate by the mailer. It must be affixed to 
the outside of the mailpiece within an envelope or similar carrier that 
can be easily opened and resealed to allow viewing of the document. 
Shipping papers are required as follows:
    a. Air transportation requirements. Except for nonregulated 
materials sent under 8.3 or 8.10 and diagnostic specimens sent under 
8.6, mailpieces containing mailable hazardous materials sent at the 
First-Class Mail, Priority

[[Page 77729]]

Mail, or Express Mail rates must include a shipping paper.
    b. Surface transportation requirements. Except for nonregulated 
materials sent under 8.3 or 8.10 and mailable ORM-D materials, 
mailpieces containing mailable hazardous materials sent at the Standard 
Mail or Package Services rates must include a shipping paper.

1.10 Air Transportation Prohibitions

    [Revise the first two sentences in 1.10 to read as follows (the 
remainder of 1.10 is unchanged):]
    All mailable hazardous materials sent at the First-Class Mail, 
Priority Mail, or Express Mail rates must meet air transportation 
requirements. The following types of hazardous materials that are 
prohibited from carriage on air transportation must not be sent at the 
First-Class Mail, Priority Mail, or Express Mail rates:
* * * * *
2.0 EXPLOSIVES (HAZARD CLASS 1)

2.1 Definition

    [In the second sentence, change ``Exhibit 1.3'' to ``Exhibit 
1.4''.]

2.2 Mailability

    [In the second sentence, change ``division 1.4'' to ``Division 
1.4S.'']
3.0 GASES (HAZARD CLASS 2)

3.1 Definition

    [In item b, change ``division 2.1 or 2.3'' to ``Division 2.1 or 
2.3''.]

3.2 Mailability

    [In the second, third, and fourth sentences, change ``division'' to 
``Division.'']

3.3 Container

    [Revise 3.3 to read as follows:]
    An other-than-metal primary receptacle containing a mailable gas 
may be acceptable if the water capacity of the primary receptacle is 4 
fluid ounces (7.22 cubic inches) or less per mailpiece and the primary 
receptacle meets 49 CFR requirements. Mailable nonflammable and 
flammable compressed gases are acceptable in metal primary receptacles 
that have a water capacity up to 33.8 fluid ounces (1 liter or 61.0 
cubic inches), depending on their internal pressure. A DOT 2P container 
must be used as the primary receptacle if the internal pressure is from 
140 to 160 psig at 130[deg]F (55[deg]C). A DOT 2Q container must be 
used as the primary receptacle if the pressure is from 161 to 180 psig 
at 130[deg]F (55[deg]C). A container with an internal pressure over 180 
psig at 130[deg]F (55[deg]C) is prohibited from mailing. Mailable 
flammable compressed gases are restricted to 33.8 fluid ounces (1 
liter) per mailpiece. Mailable nonflammable compressed gasses are 
permitted in individual 33.8 fluid ounce (1 liter) containers that must 
be securely packed within an outer shipping container. Each mailpiece 
must not exceed a total of weight of 25 pounds.

3.4 Marking

    [In the first sentence, change ``Surface Mail Only'' to `` 
``Surface Only'' or ``Surface Mail Only.'' '']
4.0 FLAMMABLE AND COMBUSTIBLE LIQUIDS (HAZARD CLASS 3)
* * * * *

4.2 Flammable Liquid Mailability

    [In items a and b, change ``secondary packaging'' to ``secondary 
container''; change ``outer packaging'' to ``outer shipping 
container''; and change ``Surface Mail Only'' to `` ``Surface Only'' or 
``Surface Mail Only.'' '']

4.3 Combustible Liquid Mailability

    [In items a and b, change ``secondary packaging'' to ``secondary 
container''; change ``outer packaging'' to ``outer shipping 
container''; and change ``Surface Mail Only'' to `` ``Surface Only'' or 
``Surface Mail Only.'' '']
    [Revise item c to read as follows:]
    c. For air or surface transportation, if the flashpoint is above 
200[deg]F (93[deg]C) the material is not regulated as a hazardous 
material. Such nonregulated materials must be properly and securely 
packaged to prevent leakage under the general packaging requirements in 
C010.

4.4 Cigarette Lighters

    [In the second sentence, change ``division 2.1'' to ``Division 
2.1''.]
    [In item c, change ``Surface Mail Only'' to `` ``Surface Only'' or 
``Surface Mail Only.'' '']
5.0 FLAMMABLE SOLIDS (HAZARD CLASS 4)
* * * * *

5.2 Mailability

    [Change ``outer packaging'' to ``outer shipping container'' and 
change ``Surface Mail Only'' to `` ``Surface Only'' or ``Surface Mail 
Only.'' '']

5.3 Matches

* * * * *
    [Revise items c and d to read as follows:]
    c. They are tightly packed in a securely sealed primary receptacle 
to prevent any shifting or movement that could cause accidental 
ignition by rubbing against adjoining items. The primary receptacle(s) 
is placed securely within an outer shipping container made of 
fiberboard, wood, or other equivalent material. Multiple primary 
receptacles may be placed in a single outer shipping container. The 
address side of the mailpiece must be marked ``Surface Only'' or 
``Surface Mail Only'' and ``Book Matches,'' ``Strike-on-Card Matches,'' 
or ``Card Matches,'' as appropriate. A shipping paper is not required.
    d. The gross weight of each mailpiece is not more than 25 pounds.
6.0 OXIDIZING SUBSTANCES, ORGANIC PEROXIDES (HAZARD CLASS 5)
* * * * *

6.2 Mailability

    [Revise 6.2 to read as follows:]
    Oxidizing substances and organic peroxides are prohibited in 
international mail. For domestic mail, a material that can qualify as 
an ORM-D material is permitted via air or surface transportation. 
Liquid materials must be enclosed within a primary receptacle having a 
capacity of 1 pint or less; the primary receptacle(s) must be 
surrounded by absorbent cushioning material and held within a leak-
resistant secondary container that is packed within a strong outer 
shipping container. Solid materials must be contained within a primary 
receptacle having a weight capacity of 1 pound or less; the primary 
receptacle(s) must be surrounded with cushioning material and packed 
within a strong outer shipping container. Each mailpiece may not exceed 
a total weight of 25 pounds. The address side of each mailpiece must be 
plainly and durably marked with ``ORM-D AIR'' or ``ORM-D,'' as 
applicable, immediately following or below the proper shipping name. A 
mailable Class 5 material sent via surface transportation must be 
marked ``Surface Mail'' or ``Surface Mail Only'' on the address side. A 
mailable material sent via air transportation must bear a shipper's 
declaration for dangerous goods.
7.0 TOXIC SUBSTANCES (HAZARD CLASS 6, DIVISION 6.1)

7.1 Definitions

    [In the first sentence, change ``division 6.1'' to ``Division 
6.1''.]

7.2 Mailability

    [In the second sentence, change ``division 6.1'' to ``Division 
6.1''.]

[[Page 77730]]

7.3 Authorized Parties

    [In the first sentence, change ``division 6.1'' to ``Division 
6.1''.]

7.4 Packaging and Marking

    [In item a, change ``inner receptacle(s)'' to ``primary 
receptacle(s)''; change ``secondary packaging'' to ``secondary 
container''; change ``outer packaging'' to ``outer shipping 
container''; and change ``Surface Mail Only'' to ``''Surface Only'' or 
``Surface Mail Only.'' '']
    [In item b, change ``secondary leakproof (for liquids) or siftproof 
(for solids) packaging'' to ``leakproof (for liquids) or siftproof (for 
solids) secondary container''; change ``secondary packaging'' to 
``secondary container''; change ``outer packaging'' to ``outer shipping 
container''; and change ``Surface Mail Only'' to ``''Surface Only'' or 
``Surface Mail Only.'' '']
* * * * *
8.0 INFECTIOUS SUBSTANCES (HAZARD CLASS 6, DIVISION 6.2)
    [Revise 8.0 to read as follows:]

8.1 General

    Division 6.2 includes infectious substances (i.e., etiologic 
agents), biological products, cultures and stocks, diagnostic 
(clinical) specimens, regulated medical waste, sharps waste, toxins, 
and used health care products. Division 6.2 materials are not permitted 
in international mail or domestic mail, except when they are intended 
for medical or veterinary use, research, or laboratory certification 
related to the public health; and only when such materials are properly 
prepared for mailing to withstand shocks, pressure changes, and other 
conditions related to ordinary handling in transit. Mailable Division 
6.2 materials sent as international mail must meet the standards in 
International Mail Manual 135. For domestic mail, mailable Division 6.2 
materials must meet the applicable standards in 8.0. Unless otherwise 
noted, all mailable Division 6.2 materials in Risk Group 2, 3, or 4 
must be prepared to meet air transportation requirements.

8.2 Definitions

    The terms used in the standards for Division 6.2 materials are 
defined as follows:
    a. Division 6.2 (infectious substance) means a material known to 
contain or suspected of containing a pathogen. A pathogen is a virus or 
microorganism (including its viruses, plasmids, or other genetic 
elements, if any) or a proteinaceous infectious particle (prion) that 
has the potential to cause disease in humans or animals. A Division 6.2 
material must be assigned to a risk group as defined in 8.2f. 
Assignment to a risk group is based on the known medical condition and 
history of the source patient or animal, endemic local conditions, 
symptoms of the source patient or animal, or professional judgment 
concerning individual circumstances of the source patient or animal. 
Infectious substances are subject to applicable requirements in 42 CFR 
72 (Interstate Shipment of Etiologic Agents).
    b. Biological product means a virus, therapeutic serum, toxin, 
antitoxin, vaccine, blood, blood component or derivative, allergenic 
product, or analogous product used in the prevention, diagnosis, 
treatment, or cure of diseases in humans or animals. A biological 
product includes a material manufactured and distributed in accordance 
with one of the following provisions: 9 CFR 102 (Licenses for 
Biological Products); 9 CFR 103 (Experimental Products, Distribution, 
and Evaluation of Biological Products Prior to Licensing); 9 CFR 104 
(Permits for Biological Products); 21 CFR 312 (Investigational New Drug 
Application); 21 CFR 314 (Applications for FDA Approval to Market a New 
Drug); 21 CFR 600-680 (Biologics); or 21 CFR 812 (Investigational 
Device Exemptions). A biological product known to contain or suspected 
of containing a pathogen in Risk Group 2, 3, or 4 must be classed as 
Division 6.2, described as an infectious substance, and assigned to UN 
2814 or UN 2900, as appropriate, unless otherwise excepted by standard.
    c. Cultures and stocks means a material prepared and maintained for 
growth and storage and containing a Risk Group 2, 3, or 4 infectious 
substance.
    d. Diagnostic (clinical) specimen means any human or animal 
material, including excreta, secreta, blood and its components, tissue, 
and tissue fluids being transported for diagnostic or investigational 
purposes, but excluding live infected animals. A diagnostic specimen is 
not assigned a UN identification number unless the source patient or 
animal has or may have a serious human or animal disease from a Risk 
Group 4 pathogen, in which case it must be classed as Division 6.2, 
described as an infectious substance, and assigned to UN 2814 or UN 
2900, as appropriate. Assignment to UN 2814 or UN 2900 is based on 
known medical condition and history of the patient or animal, endemic 
local conditions, symptoms of the source patient or animal, or 
professional judgment concerning individual circumstances of the source 
patient or animal.
    e. Regulated medical waste means a waste material (other than a 
sharp) known to contain or suspected of containing an infectious 
substance in Risk Group 2 or 3 and generated in the diagnosis, 
treatment, or immunization of human beings or animals; research on the 
diagnosis, treatment, or immunization of human beings or animals; or 
the production or testing of biological products. Regulated medical 
waste containing an infectious substance in Risk Group 4 must be 
classed as Division 6.2, described as an infectious substance, and 
assigned to UN 2814 or UN 2900, as appropriate. Regulated medical waste 
classified in Risk Group 4 (including sharps waste) is nonmailable.
    f. Risk group means a ranking of a microorganism's ability to cause 
injury through disease. A risk group is defined by criteria developed 
by the World Health Organization (WHO) that are based on the severity 
of the disease caused by the organism, the mode and relative ease of 
transmission, the degree of risk to both an individual and a community, 
and the reversibility of the disease through the availability of known 
and effective preventive agents and treatment. There is no relationship 
between a risk group and a DOT packing group. The mailer is responsible 
for accurately ranking a mailable material within the correct risk 
group. Exhibit 8.2f details the criteria for each risk group according 
to the level of risk.

Exhibit 8.2f Risk Group Criteria

----------------------------------------------------------------------------------------------------------------
            Risk group                          Pathogen               Risk to individuals    Risk to community
----------------------------------------------------------------------------------------------------------------
4................................  A pathogen that usually causes     High................  High
                                    serious human or animal disease
                                    and that can be readily
                                    transmitted from one individual
                                    to another, directly or
                                    indirectly, and for which
                                    effective treatments and
                                    preventive measures are not
                                    usually available..

[[Page 77731]]

 
3................................  A pathogen that usually causes     High................  Low.
                                    serious human or animal disease
                                    but does not ordinarily spread
                                    from one infected individual to
                                    another, and for which effective
                                    treatments and preventive
                                    measures are available..
2................................  A pathogen that can cause human    Moderate............  Low.
                                    or animal disease but is
                                    unlikely to be a serious hazard,
                                    and, while capable of causing
                                    serious infection on exposure,
                                    for which there are effective
                                    treatments and preventive
                                    measures available and the risk
                                    of spread of infection is
                                    limited..
1................................  A microorganism that is unlikely   None or Very Low....  None or Very Low.
                                    to cause human or animal
                                    disease. A material containing
                                    only such microorganisms is not
                                    subject to regulation as a
                                    hazardous material, but it is
                                    subject to the packaging
                                    requirements in 8.10, unless
                                    otherwise noted in 8.0..
----------------------------------------------------------------------------------------------------------------

    g. Sharps means any object contaminated with a pathogen or that may 
become contaminated with a pathogen through handling or during 
transportation and that is also capable of cutting or penetrating skin 
or a packaging material. Sharps include used medical waste such as 
needles, syringes, scalpels, broken glass, culture slides, culture 
dishes, broken capillary tubes, broken rigid plastic, and exposed ends 
of dental wires. Sharps waste classified in Risk Group 4 is 
nonmailable.
    h. 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.
    i. Used health care product means a medical, diagnostic, or 
research device or piece of equipment, or a personal care product used 
by consumers, medical professionals, or pharmaceutical providers that 
does not meet the definition of a diagnostic specimen, biological 
product, or regulated medical waste, is contaminated with potentially 
infectious body fluids or materials, and is not decontaminated or 
disinfected to remove or mitigate the infectious hazard prior to 
transportation. A used health care product classified in Risk Group 4 
is nonmailable.

8.3 Nonregulated Materials

    The following materials are not subject to regulation as Division 
6.2 hazardous materials and are mailable when the packaging 
requirements in 8.10 are met:
    a. A diagnostic (clinical) specimen known to contain or suspected 
of containing a microorganism in Risk Group 1, or that does not contain 
a pathogen. Also, a diagnostic specimen in which the pathogen has been 
neutralized or inactivated so that exposure to it cannot cause disease.
    b. A biological product known to contain or suspected of containing 
a microorganism in Risk Group 1, or that does not contain a pathogen. 
Also any biological product, including an experimental product or 
component of a product, subject to federal approval, permit, or 
licensing requirements, such as those required by the Food and Drug 
Administration (FDA) of the Department of Health and Human Services 
(HHS) or the U.S. Department of Agriculture (USDA).
    c. Blood collected for blood transfusion or the preparation of 
blood products; blood products; tissues intended for use in surgical 
procedures; and human cell, tissues, and cellular and tissue-based 
products regulated under authority of the Public Health Service Act 
and/or the Food, Drug, and Cosmetic Act. Also, blood collected for 
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 pathogen in 
Risk Group 2 or 3, in which case the test sample must be packaged under 
8.6.
    d. A material, including a Division 6.2 waste, that previously 
contained an infectious substance that has been treated by steam 
sterilization, chemical disinfection, or other appropriate method, so 
it no longer meets the definition of an infectious substance in Risk 
Group 2, 3, or 4.
    e. Forensic material in Risk Group 1 transported on behalf of a 
U.S. government, state, local, or Indian tribal government agency.

8.4 Packaging--General

    All materials mailable under the provisions in 8.0 must be properly 
packaged. Exhibit 8.4a lists the specific reference in 8.0 under which 
each type of mailable material must be packaged.

Exhibit 8.4a Packaging References for Materials Mailable Under 8.0

----------------------------------------------------------------------------------------------------------------
                                                                                      Risk group
                              Material                               -------------------------------------------
                                                                          1          2          3          4
----------------------------------------------------------------------------------------------------------------
Blood for Transfusion...............................................       8.10        8.6        8.6         NM
Biological Product..................................................       8.10        8.5        8.5        8.5
Culture or Stock....................................................       8.10        8.5        8.5        8.5
Diagnostic Specimen.................................................       8.10        8.6        8.6        8.5
Division 6.2 (Infectious Substance).................................       8.10        8.5        8.5        8.5
Forensic Material...................................................       8.10        8.9        8.9        8.5
Regulated Medical Waste.............................................        8.7        8.7        8.7         NM
Sharps..............................................................        8.7        8.7        8.7         NM
Toxin (Division 6.2)................................................       8.10        8.5        8.5        8.5
Treated Medical Waste...............................................       8.10        n/a        n/a        n/a
Used Health Care Product............................................        8.8        8.8        8.8        NM
----------------------------------------------------------------------------------------------------------------
NM means nonmailable; n/a mean not applicable


[[Page 77732]]

8.5 Packaging of Division 6.2 Infectious Substances

    Division 6.2 materials include infectious substances (etiologic 
agents), biological products, cultures or stocks, and toxins known or 
suspected to contain a Risk Group 2, 3, or 4 pathogen. It also includes 
diagnostic specimens known or suspected to contain a Risk Group 4 
pathogen. The packaging of Division 6.2 infectious substances is 
subject to these standards:
    a. All Division 6.2 materials must meet the packaging requirements 
in 49 CFR 173.196 and 42 CFR 72.3. Either the primary receptacle or the 
secondary container must be capable of withstanding, without leakage, 
an internal pressure that produces a pressure differential of not less 
than 0.95 bar, 14 psi (95 kPa), and temperatures in the range of -
40[deg]F to 131[deg]F (-40[deg]C to 55[deg]C) as required by 49 CFR 
173.196.
    b. The material must be packaged in a securely sealed and 
watertight primary receptacle (test tube, vial, etc.) that is enclosed 
in another watertight and durable secondary container that is securely 
sealed. Several primary receptacles may be enclosed in the secondary 
container if there is adequate cushioning material between them to 
prevent breakage during ordinary handling, and if the total volume of 
the material in all enclosed primary receptacles does not exceed 50 ml 
for liquids and 50 g for solids. The primary receptacle(s) and the 
secondary container must be marked with the international biohazard 
symbol as shown in Exhibit 8.7c(2).
    c. The space between the primary receptacle(s) and the secondary 
container at the top, bottom, and sides must contain enough absorbent 
material to take up the entire contents of the primary receptacle(s) in 
case of breakage or leakage.
    d. The primary receptacle(s) and the secondary container must be 
securely enclosed in an outer shipping container constructed of 
fiberboard or other equivalent material. No external surface of the 
outer shipping container may be less than 3.9 inches (100 mm) as 
required by 49 CFR 173.196. An itemized list of the contents of the 
primary receptacle(s) must be enclosed between the secondary container 
and the outer shipping container.
    e. Each mailpiece must be designed and constructed so that, if it 
were subject to the environmental and test conditions in 49 CFR 
178.609, there would be no release of the contents to the environment 
and no significant reduction in the effectiveness of the packaging.
    f. The address side of the mailpiece must bear the ``Etiologic 
Agents/Biohazard Material'' label required by 42 CFR 72.3(d) and must 
be sent First-Class Mail or Priority Mail using Registered Mail 
service. Each mailpiece must be marked on the address side with the 
proper shipping name and UN number of the material (e.g., ``UN 2814, 
Infectious Substances, Affecting Humans'' or ``UN 2900, Infectious 
Substances, Affecting Animals''). Each mailpiece must bear a DOT Class 
6 label for infectious substances (etiologic agents), proper UN package 
specification markings, and orientation markings. A shipping paper is 
required.
    g. Articles that include dry ice as a refrigerant for the 
infectious substance must meet the requirements of 42 CFR 72.3(c) and 
49 CFR 173.196(b)(2)(ii).

8.6 Packaging for Diagnostic Specimens in Risk Group 2 or 3

    A diagnostic (clinical) specimen known or suspected to contain a 
Risk Group 4 pathogen must be packaged under 8.5. A diagnostic specimen 
classified in Risk Group 1 must be packaged under 8.10. A diagnostic 
specimen classified in Risk Group 2 or 3 and that meets the definition 
in 8.2d must be sent as First-Class Mail or Priority Mail. Such 
materials must be packaged in a triple packaging, consisting of a 
primary receptacle, secondary container, and outer shipping container. 
The following specific packaging requirements apply:
    a. Liquid Diagnostic (Clinical) Specimens.
    (1) The specimen must be contained in a leakproof and securely 
sealed primary receptacle. A single primary receptacle may not contain 
more than 500 ml of a specimen. Multiple primary receptacles are 
permitted in a single mailpiece if the mailpiece does not contain more 
than 4,000 ml. The primary receptacle(s) must be surrounded by 
absorbent material capable of taking up the entire liquid contents if 
the primary receptacle(s) leak.
    (2) The primary receptacle(s) and the absorbent material must be 
securely packed within a secondary container in such a way that, under 
normal conditions of transport, the primary receptacle cannot break, be 
punctured, or leak its contents into the secondary container. Each 
primary receptacle must be marked with the international biohazard 
symbol as shown in Exhibit 8.7c(2).
    (3) The secondary container must be leakproof, securely sealed, and 
placed within a strong outer shipping container having suitable 
cushioning material such that any leakage of the contents does not 
impair the protective properties of the cushioning material or the 
outer shipping container.
    (4) The primary receptacle(s) or the secondary container must be 
capable of withstanding, without leakage, an internal pressure 
producing a pressure differential of not less than 0.95 bar, 14 psi (95 
kPA). The completed mailpiece must be capable of successfully passing 
the drop test in 49 CFR 178.603 at a drop height of at least 1.2 meters 
(3.9 feet). The address side of the outer shipping container must be 
clearly and durably marked ``Diagnostic Specimen.'' A shipping paper is 
not required.
    b. Solid Diagnostic Specimens.
    (1) The primary receptacle must be siftproof with a capacity of not 
more than 500 g (1.1 pounds). The primary receptacle must be marked 
with the international biohazard symbol as shown in Exhibit 8.7c(2).
    (2) If several fragile primary receptacles are placed in a single 
secondary container, they must be individually wrapped or separated to 
prevent contact between them. The secondary container must be siftproof 
to contain the contents if the primary receptacle(s) leak.
    (3) The outer shipping container may not exceed 4 kg (8.8 pounds) 
capacity. The outer shipping container must be clearly and durably 
marked ``Diagnostic Specimen.'' A shipping paper is not required.

8.7 Regulated Medical Waste and Sharps Waste

    Regulated medical waste and sharps waste known to contain or 
suspected of containing an infectious substance in Risk Group 4 are 
nonmailable. Regulated medical waste and sharps waste as defined in 
8.2e and 8.2g, respectively, and classified in Risk Group 1, 2 or 3 are 
permitted for mailing only using merchandise return service (see S923) 
with First-Class Mail or Priority Mail, subject to the following 
requirements:
    a. Authorization. Each distributor or manufacturer of a complete 
regulated medical waste or sharps waste mailing kit, including 
containers, cartons, and any other related components intended for 
mailing such waste to a storage or disposal facility, must obtain 
authorization from the USPS prior to mailing. Before applying for 
authorization, each type of mailing kit must be tested and certified 
under the standards in 8.7d by an independent party. The manufacturer 
or distributor in whose name the authorization is

[[Page 77733]]

being sought must submit a written request to the Mail Preparation and 
Standards manager, USPS Headquarters (see G043 for address). The 
request for authorization must contain the following:
    (1) An irrevocable 50,000 surety bond or letter of credit as proof 
of sufficient financial responsibility to cover disposal costs if the 
manufacturer (or distributor) ceases doing business before all its 
shipping containers are disposed of or to cover cleanup costs if spills 
occur while the containers are in USPS possession. The surety bond or 
letter of credit must be issued in the name of the manufacturer or 
distributor seeking the authorization and must name the USPS as the 
beneficiary or obligee, as appropriate.
    (2) Address of the headquarters or general business office of the 
distributor or manufacturer seeking the authorization.
    (3) Address of each disposal and storage site.
    (4) List of all types of mailing kits to be covered by the request, 
a complete sample of each mailing kit, and proof of package testing 
certifications performed by the independent testing facility that 
subjected the packaging materials to the testing requirements in 8.7d.
    (5) Copy of the proposed manifest to be used with all mailings.
    (6) 24-hour toll free telephone number for emergencies.
    (7) List of the types of waste to be mailed for disposal.
    (8) Copy of the merchandise return service label to be used with 
each mailing kit.
    b. Packaging. Regulated medical waste and sharps waste in Risk 
Group 4 are nonmailable. A waste material treated by steam 
sterilization, chemical disinfection, or other appropriate method, so 
it no longer meets the definition of an infectious substance in Risk 
Group 2, 3, or 4 must be packaged under 8.10. The packaging for 
regulated medical waste and sharps waste in Risk Group 1, 2, or 3 is 
subject to these standards:
    (1) Regulated medical waste and sharps waste must be collected in a 
rigid, securely sealed, and leakproof primary receptacle. For sharps 
waste, the primary receptacle must also be puncture-resistant. The 
primary receptacle may not contain more than 50 ml (1.66 ounces) of 
residual waste liquid and may not have a maximum capacity that exceeds 
3 gallons in volume. The primary receptacle must display the 
international biohazard symbol shown in Exhibit 8.7c(2). The primary 
receptacle must maintain its integrity when exposed to temperatures 
between 0[deg] and 120[deg]F.
    (2) The primary receptacle must be packaged within a watertight 
secondary container or containment system. The secondary container may 
consist of more than one component. If one of the components is a 
plastic bag, it must be at least 3 ml in thickness and be used in 
conjunction with a strong fiberboard box. A plastic bag by itself does 
not meet the requirement for a secondary container. Several primary 
receptacles may be enclosed in a secondary container.
    (3) The secondary container must be enclosed in a strong outer 
shipping container constructed of 200-pound grade corrugated 
fiberboard. The box certification must be displayed on the bottom of 
the fiberboard box. The joints and flaps of the outer shipping 
container must be securely taped, glued, or stitched to maintain the 
integrity of the container. When tape or glue is used to secure an 
outer shipping container, the material must be water-resistant. 
Fiberboard boxes with interlock bottom flaps (i.e., easy-fold) are not 
permitted as outer shipping containers. The secondary container must 
fit securely within the outer shipping container to prevent breakage 
during ordinary processing.
    (4) There must be enough material within a watertight barrier to 
absorb and retain three times the total liquid allowed within the 
primary receptacle (150 ml per primary receptacle) in case of leakage.
    (5) Each mailpiece must not weigh more than 25 pounds.
    (6) In each mailing kit, the authorized manufacturer or distributor 
must include a step-by-step instruction sheet that clearly details the 
proper sequence and method of kit assembly prior to mailing to prevent 
package failure during transport due to improper assembly.
    c. Mailpiece Labeling, Marking, and Documentation. Regulated 
medical waste and sharps waste must meet the following requirements:
    (1) Each primary receptacle and outer shipping container must bear 
a label, which cannot be detached intact, showing:
    (a) The company name of the manufacturer or the distributor to 
which the mailing authorization is issued.
    (b) The USPS Authorization Number.
    (c) The container ID number (or unique model number) signifying 
that the packaging material is certified and that the manufacturer or 
distributor obtained the authorization required by 8.7a.
    (2) The primary receptacle(s) and the outer shipping container must 
bear the international biohazard symbol in black with either a 
fluorescent orange or fluorescent red background as shown in Exhibit 
8.7c(2).

Exhibit 8.7c(2) International Biohazard Symbol
[GRAPHIC] [TIFF OMITTED] TP19DE02.005

    (3) Each mailpiece must have a four-part waste manifest, which also 
serves as a shipping paper. The manifest must be affixed to the outside 
of the mailpiece in an envelope or similar carrier that can be easily 
opened and resealed to allow review of the document. The manifest must 
comply with all applicable requirements imposed by the laws of the 
state from which the kit is mailed. At a minimum, the information in 
Exhibit 8.7c(3) must be on the manifest.
Exhibit 8.7c(3)

Manifest for Regulated Medical Waste and Sharps Waste Containers

1. Generator (Mailer)
    a. Name.
    b. Complete address (not a Post Office box).
    c. Telephone number.
    d. Description of contents of mailing container. ``Regulated 
Medical Waste'' or ``Regulated Medical Waste--Sharps'' is required as 
appropriate.
    e. Date container was mailed.
    f. State permit number of approved facility in which contents are 
to be disposed.
2. Destination Facility (Disposal Site)
    Complete address (not a Post Office box).
3. Generator's (Mailer's) Certification
    The following certification statement must be printed on manifest:
    ``I certify that this container has been approved for the mailing 
of [insert either ``regulated medical waste'' or ``sharps waste,'' as 
appropriate], has been prepared for mailing in accordance with the 
directions for that purpose, and does not contain excess liquid or 
nonmailable material in violation of the applicable Postal Service 
regulations. I AM AWARE THAT FULL RESPONSIBILITY RESTS WITH THE 
GENERATOR (MAILER) FOR ANY VIOLATION OF 18

[[Page 77734]]

U.S.C. 1716 WHICH MAY RESULT FROM PLACING IMPROPERLY PACKAGED ITEMS IN 
THE MAIL. I also certify that the contents of this consignment are 
fully and accurately described above by proper shipping name and are 
classified, packed, marked, and labeled, and in proper condition for 
carriage by air according to the national governmental regulations.''
    This statement must be followed by printed or typewritten name of 
generator (mailer), signature of generator, and date signed.
4. Destination Facility (Storage or Disposal Site)
    The following certification statement of receipt, treatment, and 
disposal must be printed on manifest:
    ``I certify that the contents of this container have been received, 
treated, and disposed of in accordance with all local, State, and 
Federal regulations.''
    This statement must be followed by printed or typewritten name of 
an authorized recipient at destination facility, signature of 
authorized recipient, and date signed.
5. Transporter Intermediate Handler Other Than the Postal Service (If 
Different From Destination Facility)
    a. Name.
    b. Complete address (not a Post Office box).
    c. Printed or typewritten name of transporter or intermediate 
handler.
    d. Signature of transporter or intermediate handler and date 
signed.
6. Serialized Waste Manifests
    Each waste manifest or mail disposal service shipping record must 
be serialized using a unique numbering system for identification 
purposes.
7. Comment Area
    Each manifest must contain an area designated for entering comments 
or noting discrepancies.
8. Completion and Distribution of Waste Manifest
    Each manifest must contain instructions for properly completing the 
four-part form. Copies of the form must be distributed as follows:
    a. One copy must be kept by generator (mailer).
    b. One copy must be kept by transporter or intermediate handler for 
90 days.
    c. One copy must be kept by destination facility for 90 days.
    d. One copy must be mailed to generator by destination facility.
9. Emergency Telephone Number
    Each manifest must bear the following statement with appropriate 
information:
    ``IN CASE OF EMERGENCY, OR THE DISCOVERY OF DAMAGE OR LEAKAGE, CALL 
1-800--
.''
    (4) The outer shipping container must bear a properly prepared 
merchandise return service label (see S923). The merchandise return 
service permit must be held in the same name as that of the 
authorization.
    (5) The outer shipping container must be marked on two opposite 
side walls with the package orientation marking in 49 CFR 173.312 to 
identify the proper upright position of the mailpiece during handling.
    (6) Mailpieces containing regulated medical waste or sharps waste 
must be marked on the address side with the correct UN number and 
proper shipping name (e.g., ``Regulated Medical Waste, UN 3291'' or 
``Regulated Medical Waste--Sharps, UN 3291'').
    d. Package Testing. Testing must be performed on one sample of each 
type of kit to prove compliance with 8.7a. The sample mailing kit must 
withstand the tests in 49 CFR 178.604 (leakproof test), 178.606 
(stacking test), 178.608 (vibration standard), and 178.609(e), (f), and 
(h) (test requirements for packaging for infectious substances). In 
addition, the absorbent material must withstand an absorbency test that 
satisfies the requirements in 8.7b(4). The test results must show that 
if every kit prepared for mailing were to be subject to the 
environmental and test conditions in 49 CFR, there would be no release 
of the contents to the environment and no significant reduction in the 
effectiveness of the packaging. Periodic retesting must be performed at 
least once every 24 months.

8.8 Packaging of Used Health Care Products

    A used health care product known or suspected to contain a Risk 
Group 4 pathogen is nonmailable. A used health care product meeting the 
definition in 8.2i, classified in Risk Group 1, 2, or 3, and being 
returned to the manufacturer or manufacturer's designee is mailable as 
First-Class Mail or Priority Mail subject to the following packaging 
requirements:
    a. Each used health care product must be drained of liquid to the 
extent possible and placed in a watertight primary receptacle designed 
and constructed to ensure that it remains intact under normal 
conditions of transport. For a used health care product capable of 
cutting or penetrating skin or packaging material, the primary 
receptacle must be capable of retaining the product without puncture of 
the packaging under normal conditions of transport. The primary 
receptacle must be marked with the international biohazard symbol as 
shown in Exhibit 8.7c(2).
    b. Each primary receptacle must be placed inside a watertight 
secondary container designed and constructed to ensure that it remains 
intact under normal conditions of transport. The secondary container 
must also be marked with the international biohazard symbol as shown in 
Exhibit 8.7c(2).
    c. The secondary container must be placed inside an outer shipping 
container with sufficient cushioning material to prevent movement 
between the secondary container and the outer shipping container. An 
itemized list of the contents of the primary receptacle 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 outer shipping container. A shipping 
paper and a content marking on the outer shipping container are not 
required.

8.9 Packaging of Forensic Material in Risk Groups 2 and 3

    Forensic material in Risk Group 1 sent on behalf of a U.S. 
government, state, local, or Indian tribal government agency must be 
packaged under 8.10. Forensic material known or suspected to contain a 
Risk Group 4 infectious substance must be packaged under 8.5. Forensic 
material known or suspected to contain a Risk Group 2 or 3 pathogen is 
mailable as First-Class Mail or Priority Mail when packaged in a triple 
packaging, consisting of a primary receptacle, secondary container, and 
outer shipping container. The forensic material 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 container from breakage. The 
absorbent material must be capable of taking up the entire liquid 
contents of the primary receptacle in case of leakage. The primary 
receptacle must be marked with the international biohazard symbol as 
shown in Exhibit 8.7c(2). The primary receptacle and the absorbent and 
cushioning material must be enclosed in a watertight and securely 
sealed secondary container that is snugly packed within a strong and 
securely sealed outer shipping container. The secondary container must 
also display the international biohazard symbol as shown in Exhibit 
8.7c(2). A shipping paper and a content

[[Page 77735]]

marking on the outer shipping container are not required.

8.10 Packaging for Risk Group 1 Materials

    Division 6.2 materials in Risk Group 1 are not subject to 
regulation as hazardous materials (see 8.3), but when presented for 
mailing they must be properly packaged. Regulated medical waste, sharps 
waste, and used health care products classified in Risk Group 1 must be 
packaged and mailed under the applicable requirements in 8.7 or 8.8. 
All other Risk Group 1 materials are mailable as First-Class Mail, 
Priority Mail, or Package Services. 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. The primary 
receptacle must be marked with the international biohazard symbol as 
shown in Exhibit 8.7c(2). The primary receptacle and the absorbent and 
cushioning material must be snugly enclosed in a strong outer shipping 
container that is securely sealed. A shipping paper and a content 
marking on the outer shipping container are not required. Risk Group 1 
diagnostic specimens and biological products are subject to the 
following packaging standards:
    a. Liquid Diagnostic (Clinical) Specimens and Biological Products. 
A diagnostic (clinical) specimen in Risk Group 4 or a biological 
product in Risk Group 2, 3, or 4 must be packaged under 8.5. A 
diagnostic specimen in Risk Group 2 or 3 must be packaged under 8.6. 
The packaging of a diagnostic specimen (e.g., a urine specimen or blood 
specimen used in drug-testing programs or insurance purposes) or a 
biological product (e.g., polio vaccine) in Risk Group 1 is subject to 
the following standards:
    (1) Not Exceeding 50 ml. A diagnostic 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. The primary receptacle(s) must be marked with the 
international biohazard symbol as shown in Exhibit 8.7c(2). 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 having a leakproof barrier that can 
prevent failure of the secondary container if the primary receptacle(s) 
leaks during shipment. The secondary container may serve as the outer 
shipping container. A shipping paper and a content marking on the outer 
shipping container are not required.
    (2) Exceeding 50 ml. In addition to meeting the requirements in 
8.10a(1), a clinical specimen or biological product that exceeds 50 ml 
per mailpiece also is subject to these requirements:
    (a) A single primary receptacle must not contain more than 1,000 ml 
of specimen; two or more primary receptacles whose combined volume does 
not exceed 1,000 ml may be enclosed in a single secondary container.
    (b) The secondary container cannot serve as the outer shipping 
container; the secondary container must be enclosed in a fiberboard box 
or container of equivalent strength that serves as the outer shipping 
container; the maximum amount of a specimen that may be enclosed in a 
single mailpiece must not exceed 4,000 ml.
    b. Dry Specimens. A dry specimen, such as a blood spot or fecal 
smear in Risk Group 1 must be completely dried prior to enclosing it in 
a securely sealed primary receptacle. The primary receptacle must be 
marked with the international biohazard symbol as shown in Exhibit 
8.7c(2). Cushioning material to withstand shock and pressure changes is 
only required if the dry specimen is held within a breakable receptacle 
or on a glass slide. When required, the cushioning material must 
surround the primary receptacle to prevent breakage or damage to the 
primary receptacle. The primary receptacle (and cushioning material, if 
required) must be enclosed in a secondary container having a leakproof 
barrier that can prevent failure of the secondary container if the 
primary receptacle breaks during shipment. The secondary container may 
serve as the outer shipping container. A shipping paper and a content 
marking on the outer shipping container are not required.
9.0 RADIOACTIVE MATERIALS (HAZARD CLASS 7)
    [Change ``Publication 52, Acceptance of Hazardous, Restricted, or 
Perishable Matter'' to ``Publication 52, Hazardous, Restricted, or 
Perishable Mail.'']
10.0 CORROSIVES (HAZARD CLASS 8)
* * * * *

10.2 Mailability

    [In item a, change ``secondary packagings'' to ``secondary 
container''; change ``secondary packaging'' to ``secondary container''; 
and change ``outer packaging'' to ``outer shipping container''.]
    [In item b, change ``secondary packaging'' to ``secondary 
container'' and change ``outer packaging'' to ``outer shipping 
container''.]

10.3 Marking

    [In the first sentence, change ``Surface Mail Only'' to ``Surface 
Only'' or ``Surface Mail Only.'']

10.4 Nonspillable Wet Electric Storage Batteries

* * * * *
    [Revise item a to read as follows:]
    a. The nonspillable battery must be protected from short circuits, 
surrounded with sufficient cushioning material, and securely packaged 
in a strong fiberboard box that serves as the outer shipping container. 
[In item b, change ``outer packaging'' to ``outer shipping 
container''.]
* * * * *
    [In item d, change ``50 pounds'' to ``25 pounds.'']
11.0 MISCELLANEOUS HAZARDOUS MATERIALS (HAZARD CLASS 9)

11.1 Definition

    [In the second sentence, delete ``magnetized materials,''.]
* * * * *

11.3 Marking

    [In the first sentence, change ``Surface Mail Only'' to ``Surface 
Only'' or ``Surface Mail Only.'']

11.4 Dry Ice

    [In item a, change the heading ``Air Transportation'' to ``Air 
Transportation Requirements.'']
    [In item b, change the heading ``Surface Transportation'' to 
``Surface Transportation Requirements''. Also change ``Surface Mail 
Only'' to ``Surface Only'' or ``Surface Mail Only.'']
* * * * *
    [Renumber 11.5 as 12.0 and change the heading to read as follows:]
12.0 OTHER REGULATED MATERIALS

12.1 Magnetized Materials

    [Change the first sentence in 12.1 to read as follows (the 
remainder of 12.1 is unchanged):]

[[Page 77736]]

    A magnetized material is not classified within any of the nine 
hazard classes. Such material is regulated as a hazardous material only 
if offered for carriage on air transportation and when it has a 
magnetic field strength capable of causing the deviation of aircraft 
instruments. Regulated magnetized materials are mailable subject to the 
following limitations:
    a. Definition.
    [In the second sentence, change ``a hazard class 9 material'' to 
``a hazardous material.'']
    b. Mailability.
    [In the third sentence, change ``Publication 52'' to ``Publication 
52, Hazardous, Restricted, and Perishable Mail.'']
* * * * *

C024 Other Restricted or Nonmailable Matter

* * * * *
    [Renumber 18.0 and 19.0 as19.0 and 20.0, and insert new 18.0 to 
read as follows:]
18.0 ODD-SHAPED ITEMS IN PAPER ENVELOPES
    Pens, pencils, key rings, bottle caps, and other similar odd-shaped 
items are not permitted in letter-size or flat-size paper envelopes 
unless they are wrapped within the other contents of the envelope to 
streamline the shape of the mailpiece and prevent damage during postal 
processing. If an odd-shaped item is not properly wrapped, it could 
burst through the envelope and cause injury to employees and damage to 
USPS processing equipment. Odd-shaped items that are properly wrapped 
within paper envelopes and are sent at the First-Class Mail or Standard 
Mail nonautomation rates may be subject to the nonmachinable surcharge 
under E130 or E620, as applicable. Properly wrapped odd-shaped items in 
automation rate letter-size mail are subject to the standards in C810. 
Flat-size automation rate mail is subject to the uniform thickness 
requirement in C820.
* * * * *

F Forwarding and Related Services

F000 Basic Services

F010 Basic Information

* * * * *
5.0 CLASS TREATMENT FOR ANCILLARY SERVICES

5.1 First-Class Mail and Priority Mail

* * * * *
    [Revise item e to read as follows:]
    e. First-Class Mail or Priority Mail bearing ``Change Service 
Requested'' must include the appropriate Address Change Service (ACS) 
participant code from an authorized ACS participant. ``Change Service 
Requested'' is not permitted for the following:
    (1) Priority Mail, except for Priority Mail containing perishable 
matter under C022 (other than live animals).
    (2) First-Class Mail or Priority Mail containing live animals under 
C022, hazardous materials under C023, or restricted matter underC024.
    (3) First-Class Mail or Priority Mail with a special service other 
than Delivery Confirmation or Signature Confirmation.

Exhibit 5.1 Treatment of Undeliverable First-Class Mail and Priority 
Mail

    [Revise the listing for ``Change Service Requested'' to read as 
follows:]

------------------------------------------------------------------------
      Mailer endorsement              USPS treatment of UAA pieces
------------------------------------------------------------------------
 
                                * * * * *
``Change service requested''   In all cases: Separate notice of new
 \2\.                           address or reason for nondelivery
                                provided (in either case, address
                                correction fee charged); piece disposed
                                of by USPS.
                               Restrictions: This endorsement may be
                                used only by mailers authorized to
                                participate in Address Change Service
                                (ACS) and only for: (1) First-Class Mail
                                (excluding live animals, hazardous
                                materials, and restricted matter)
                                bearing a proper ACS participant code.
                                (2) Priority Mail containing perishable
                                matter (other than live animals) and
                                bearing a proper ACS participant code
                                and the marking ``Perishable.''
                               Delivery Confirmation and Signature
                                Confirmation are the only special
                                services permitted with this
                                endorsement.
                               Prohibitions: This endorsement is not
                                permitted for First-Class Mail or
                                Priority Mail containing live animals,
                                hazardous materials, or restricted
                                matter.
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
    [Revise the text of footnote 2 to read as follows:]
    2. Valid only for ACS participating pieces, other than pieces 
containing live animals, hazardous materials, or restricted matter.
* * * * *

5.3 Standard Mail

* * * * *
    [Reletter items c through j as d though k, and insert new item c to 
read as follows:]
    c. The endorsement ``Change Service Requested'' is not permitted 
for Standard Mail containing perishable matter under C022, hazardous 
materials under C023, or restricted matter under C024. Standard Mail 
containing perishable matter, hazardous materials, or restricted matter 
must bear the endorsement ``Address Service Requested,'' ``Forwarding 
Service Requested,'' or ``Return Service Requested.''
* * * * *

Exhibit 5.3a Treatment of Undeliverable Standard Mail

    [Revise the listing for ``Change Service Requested'' to read as 
follows:]

------------------------------------------------------------------------
      Mailer endorsement              USPS Treatment of UAA Pieces
------------------------------------------------------------------------
No endorsement \1\...........  In all cases: Piece0 disposed of by USPS.
                               Prohibitions: Standard Mail containing
                                perishable matter, hazardous materials,
                                or restricted matter must bear a
                                permissible endorsement.

[[Page 77737]]

 
``Address Service Requested''  * * * * *
 \2\.
 
* * * * *                      * * * * *
 
``Change Service Requested''   In all cases: Separate notice of new
 \3\.                           address or reason for nondelivery
                                provided (in either case, address
                                correction fee charged); piece disposed
                                of by USPS.
                               Restrictions: Delivery Confirmation is
                                the only special service permitted with
                                this endorsement.
                               Prohibitions: This endorsement is not
                                permitted for Standard Mail containing
                                perishable matter, hazardous materials,
                                or restricted matter.
------------------------------------------------------------------------

    [Revise footnote 1 and add new footnotes 2 and 3 to read as 
follows:]
    1. Not valid for pieces containing perishable matter, hazardous 
materials, or restricted matter.
    2. Valid for all pieces, including Address Change Service (ACS) 
participating pieces.
    3. Not valid for pieces containing perishable matter, hazardous 
materials, or restricted matter. Valid for all other pieces, including 
Address Change Service (ACS) participating pieces.
* * * * *

5.4 Package Services

* * * * *
    [Reletter items c through e as d through f, and insert new item c 
to read as follows:]
    c. The endorsement ``Change Service Requested'' is not permitted 
for Package Services mail containing perishable matter under C022, 
hazardous materials under C023, or restricted matter under C024.
* * * * *

Exhibit 5.4 Treatment of Undeliverable Package Services Mail

    [Revise the listing for ``Change Service Requested'' to read as 
follows:]

------------------------------------------------------------------------
            Mailer endorsement              USPS Treatment of UAA Pieces
------------------------------------------------------------------------
* * * * *                                   * * * * *
 
``Change Service Requested'' \2\..........  In all cases: Separate
                                             notice of new address or
                                             reason for nondelivery
                                             provided (in either case,
                                             address correction fee
                                             charged); piece disposed of
                                             by USPS.
                                            Restrictions: Delivery
                                             Confirmation and Signature
                                             Confirmation are the only
                                             special services permitted
                                             with this endorsement.
                                            Prohibitions: This
                                             endorsement is not
                                             permitted for Package
                                             Services Mail containing
                                             perishable matter,
                                             hazardous materials, or
                                             restricted matter.
------------------------------------------------------------------------

    [Add new footnote 2 to read as follows:]
    2. Not valid for pieces containing perishable matter, hazardous 
materials, or restricted matter. Valid for all other pieces, including 
Address Change Service (ACS) participating pieces.
* * * * *
    An appropriate amendment to 39 CFR part 111 to reflect these 
changes will be published if the proposal is adopted.

Stanley F. Mires,
Chief Counsel, Legislative.
[FR Doc. 02-31990 Filed 12-18-02; 8:45 am]
BILLING CODE 7710-12-P