[Federal Register Volume 68, Number 109 (Friday, June 6, 2003)]
[Rules and Regulations]
[Pages 33858-33873]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-14185]


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POSTAL SERVICE

39 CFR Part 111


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

ACTION: Final rule.

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SUMMARY: In this final rule, the Postal Service adopts revisions to 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 adopt many 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 53117-53144) and the subsequent change published 
on August 27, 2002 (67 FR 54967). As adopted by the Postal Service, 
these DMM revisions will provide a greater level of safety for handling 
and transporting mailable infectious substances in the mailstream. 
These changes will also facilitate domestic and international air 
transportation by aligning the Postal Service mailing standards with 
the current international standards for the transport of hazardous 
materials.
    Other minor changes and clarifications are also adopted to the 
hazardous materials mailing standards in DMM C021, C023, C024, C050, 
and F010 to improve clarity and reduce misunderstandings; 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.

EFFECTIVE DATE: June 12, 2003. However, mailers using a business reply 
mail format for diagnostic (clinical) specimen mailpieces or a 
merchandise return service format for sharps waste or regulated medical 
waste mailpieces, are

[[Page 33859]]

provided with a phase-in period through January 1, 2004.

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

SUPPLEMENTARY INFORMATION: On December 19, 2002, the Postal Service 
published a proposed rule in the Federal Register (67 FR 77726-77737) 
that proposed revisions to the standards in DMM C023 for mailing 
Division 6.2 infectious substances. The proposal was initiated to align 
the Postal Service standards with the DOT Federal regulations in 49 CFR 
and to make other minor changes and clarifications to the related 
mailing standards in DMM C021, C023, C024, C050, and F010.
    Part A of this document provides background information on why the 
Postal Service needs to adopt these changes. Part B identifies and 
responds to the comments received by the Postal Service on the proposed 
rule. Part C summarizes the changes adopted by the Postal Service in 
this final rule. The actual changes to the DMM appear at the end of 
this final rule.

Part A--Background 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 adopting 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 53117-53144 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 is adopting only the 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 will 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 is nonmailable in the U.S. mail because it exceeds the 
maximum size and weight limits for mailing and it also would pose an 
unacceptable risk level during Postal Service transport and handling.

Part B--Comments on the Proposed Rule

    On December 19, 2002, the Postal Service published a proposed rule 
in the Federal Register (67 FR 77726-77737) that provided information 
on the revisions to the mailing standards in the DMM that the Postal 
Service proposed to adopt. The Postal Service solicited comments on the 
proposed rule from members of the general public and responses were 
received from nine parties. The parties represented: four authorized 
sharps mailers; three commercial medical laboratories that process 
diagnostic (clinical) specimens received through the mail; one 
institute comprised of two separate trade associations that represented 
members involved in private waste services and manufacturing 
businesses; and one law firm representing a group of manufacturers of 
healthcare products.
    The comments received generally fell into one of the following four 
categories: comments on the proposed effective date; comments on the 
proposed rules for diagnostic (clinical) specimens; comments on the 
proposed rules for mailable types of regulated medical waste and sharps 
waste; and comments in support of the Postal Service proposed rule. A 
summary of the comments grouped by category is detailed in items 1 
through 4.

1. Comments Related to the Effective Date of the Final Rule

    Four commenters, including three of the sharps mailers and the 
institute, opposed the Postal Service proposal of an effective date of 
April 30, 2003. Two of the sharps mailers requested an effective date 
of six months after the date of the final rule, while the other two 
commenters requested an effective date of one year after the date of 
the final rule. All commenters felt that a

[[Page 33860]]

delayed effective date was needed to allow them and their clients a 
sufficient amount of time in which to use up preexisting packaging that 
is already in circulation. The Postal Service agrees that a phase-in 
period is needed and in this final rule has adopted an effective date 
of June 12, 2003, with a phase-in period through January 1, 2004. This 
phase-in period will allow for mailer implementation of the new 
packaging requirements for diagnostic (clinical) specimen mailpieces 
using a business reply mail format and regulated medical waste or 
sharps waste mailpieces using a merchandise return service format.

2. Comments Related to the Proposed Changes Affecting Diagnostic 
(Clinical) Specimens

    Four commenters, including the three medical laboratories and the 
law firm, submitted comments related to the proposed requirements for 
clinical specimens.
    Two of the medical labs and the law firm all maintained that the 
Postal Service proposal to require placement of the biohazard symbol on 
the primary container of a Risk Group 1, 2 or 3 diagnostic (clinical) 
specimen was impractical. They noted that mailers would incur added 
costs to place the symbol on the primary container. One commenter also 
noted that under the Federal requirements issued by the U.S. Department 
of Occupational Health and Safety Administration (OSHA), the biohazard 
symbol is required to appear on the secondary container. For these 
reasons, in this final rule the Postal Service has changed the 
placement requirement for the biohazard symbol on Risk Group 1, 2, and 
3 specimens. For mailable types of Risk Group 1, 2, and 3 specimens, 
the biohazard symbol is required to appear on the secondary packaging, 
except in the instance where the secondary packaging also serves as the 
outer shipping container for a Risk Group 1 specimen. In that instance, 
then the biohazard symbol must appear on the inner packaging or on the 
primary container. The biohazard symbol must not appear on the outer 
shipping container of a mailable Risk Group 1, 2, or 3 specimen.
    One of the medical labs opposed the Postal Service proposal to 
include diagnostic (clinical) specimens in the description of Division 
6.2 materials in DMM C023.8.1 because they felt it could be confusing 
to most mailers. The text in DMM C023.8.1 is intended to generally 
identify the items that are described under the category of Division 
6.2, some of which are regulated as infectious substances, and some of 
which are not. The definition of a Division 6.2 material (infectious 
substance) is defined in DMM C023.8.2a, and that definition very 
closely mirrors the definition adopted by DOT in 49 CFR. The Postal 
Service does not feel that the general explanation in DMM C023.8.1 is 
confusing or misleading, but has made some minor changes to the text in 
the final rule for the purpose of clarity.
    The same medical lab also asked whether it was the intent of the 
Postal Service to mirror the risk group classifications adopted by DOT. 
The answer is yes. The Postal Service believes this intent was clearly 
stated in the proposed rule, and it is also restated in Part C of this 
final rule. This commenter also asked whether the Postal Service 
classified all diagnostic (clinical) specimens collected for insurance 
purposes or through drug testing programs as Risk Group 1 materials. 
The Postal Service cannot make such a determination. In the proposed 
rule and in this final rule, the Postal Service has placed the 
responsibility for the proper determination of the Risk Group on the 
sender (i.e. generally the health care professional or individual who 
collects the specimen) as stated in DMM C023.8.2f. The Postal Service 
position on this point is in alignment with the stance DOT adopted in 
49 CFR. The Postal Service suggests that packaging distributors include 
information to inform the collector of the specimen that the packaging 
may only be used to send Risk Group 1 specimens and that different 
packaging with stricter requirements must be used to send Risk Group 2, 
3, or 4 specimens.
    Another one of the medical labs that provided comments requested 
that the Postal Service clarify what materials are acceptable for a 
primary and secondary container holding a dry specimen. They also asked 
the Postal Service to clarify what would constitute a ``securely 
sealed'' primary receptacle in DMM C023.8.10b. Unlike the DOT 
regulations, the Postal Service proposed packaging requirements for dry 
clinical specimens since these types of specimens are routinely sent 
through the U.S. mail. Dry specimens often include materials such as 
saliva swabs, dried blood spots, and fecal smears. In the final rule, 
the Postal Service has made a few minor changes to the text for 
packaging a dry specimen in order to clarify the requirements. The 
Postal Service believes these changes are sufficient.

3. Comments Related to the Proposed Changes Affecting Regulated Medical 
Waste and Sharps Waste

    Five parties, including the four sharps mailers and the institute, 
submitted comments related to the proposed changes affecting the 
mailing of regulated medical waste and sharps waste. For Postal Service 
purposes, regulated medical waste is defined in DMM C023.8.2e and 
sharps waste is defined in DMM C023.8.2g.
    All four sharps mailers opposed the Postal Service proposal to 
limit the capacity of a sharps primary receptacle to a maximum of 3 
gallons. Two commenters requested a limit of 5 gallons, one requested a 
limit of 11 gallons, and the other specified no maximum limit. Over the 
past few years, the Postal Service has experienced instances in which 
mailpieces containing sharps waste and having a 5-gallon primary 
receptacle have been found broken open in the mailstream. Although the 
number of incidents is small, the Postal Service believes that when 
properly designed and packaged prior to mailing, no approved sharps 
container should break open while in the mailstream. It was for this 
reason, and to ensure the safety of postal employees who handle these 
mailpieces, that the Postal Service proposed the new design 
requirement. The Postal Service does not agree with the commenters that 
a primary receptacle used to collect sharps (and designed for return 
via the U.S. mail) needs to be larger than 3 gallons in capacity. Most 
sharps container systems previously approved by the Postal Service have 
a primary receptacle with a capacity of less than 1 gallon. Primary 
receptacles having a capacity of 3 gallons or greater are not generally 
used to collect sharps waste for mail-back purposes, rather they are 
used to collect other types of nonsharps waste. Accordingly, the Postal 
Service will adopt a 3-gallon limit for a primary receptacle used to 
collect sharps waste as defined in DMM C023.8.2g and a 5-gallon limit 
for a primary receptacle used to collect regulated medical waste as 
defined in DMM C023.8.2e.
    One sharps mailer opposed the Postal Service proposal to change the 
requirements for the secondary container for regulated medical waste 
and sharps waste packaging systems. The same sharps mailer also opposed 
the Postal Service proposal to prohibit easy-fold bottoms on outer 
shipping containers if they are not reinforced with a water-resistant 
tape. The commenter felt that the previous Postal Service requirement 
which allowed a

[[Page 33861]]

secondary container to consist of a 3 mil plastic bag with a reinforced 
fiberboard sleeve (open on the top and bottom) was sufficient. They 
also felt that requiring a reinforced bottom on the outer shipping 
container was unnecessary and would increase their production costs. 
The Postal Service feels these changes are necessary for safety 
reasons. At least two incidents have occurred in which the bottom of an 
auto-fold style outer shipping container gave way during postal 
handling causing the bagged primary receptacle to slide out of the 
reinforced sleeve and through the bottom of the outer shipping 
container. In this situation, the only level of protection from the 
primary container was the 3 mil plastic bag, which increased the safety 
risk to postal employees. For this reason, the Postal Service adopts 
the packaging change for regulated medical waste and sharps waste 
mailpieces that requires the secondary container be completely enclosed 
in a watertight 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 mil thick and be 
used in conjunction with a strong and securely sealed fiberboard box. A 
plastic bag by itself will not meet the requirement for a secondary 
container. The Postal Service also adopts the packaging change for 
regulated medical waste and sharps waste mailpieces to require that the 
bottom of the outer shipping container and all joints and flaps 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.
    One sharps mailer and the institute commented that the Postal 
Service proposed definition of ``regulated medical waste'' should also 
include sharps. Both felt that the Postal Service should not maintain a 
separate category for sharps waste since DOT had no such distinction. 
One commenter further stated that if sharps waste were included in the 
definition of regulated medical waste, then the Postal Service would 
only need one set of packaging requirements and mailers would not have 
to use different marking requirements for mailpieces containing 
regulated medical waste and sharps waste. The Postal Service does not 
agree with those arguments. Since the Postal Service began allowing 
medical waste in the mail more than ten years ago, there has been, and 
continues to be, a great deal of concern involving the potential 
dangers associated with sharps waste should package failure occur 
during postal handling. The Postal Service has experienced a few 
instances in which a used syringe was found protruding from a sharps 
waste mailpiece that was not properly packaged prior to mailing. For 
this reason, the Postal Service will continue to maintain separate 
categories for sharps waste and other mailable types of regulated 
medical waste. This distinction will include separate requirements for 
the primary receptacles and different marking requirements for the 
outer shipping container. The Postal Service does not feel this will 
present a hardship on mailers since many already design and market 
their waste container systems for specific uses. It can also be noted 
that healthcare professionals generally do not mix sharps waste in the 
same containers used to collect other nonsharps medical waste.
    Although not proposed by the Postal Service, one sharps waste 
mailer recommended the Postal Service require that sharps container 
systems be tested by ``certified'' labs, rather than by independent 
labs, as already permitted in DMM C023.8.7d. The Postal Service has not 
noted any significant problems with the use of independent labs, and 
therefore, sees no reason to adopt this recommendation. The problems 
associated with package failure of sharps waste container systems 
appear to be caused by container system design or the improper assembly 
of the container system by the end user prior to mailing.
    The institute recommended that the Postal Service establish a 
``performance-based'' standard for packaging rather than adopt new 
requirements for sealing the outer shipping container. The institute 
further suggested that the Postal Service allow a manufacturer or 
distributor to prove that their packaging material is safe when placed 
in the mail. We believe the commenter misinterpreted our intent and 
might not be aware of the preexisting requirements for package testing. 
The Postal Service has always required that packaging systems for 
sharps waste be tested by an independent testing facility using several 
of the tests detailed in 49 CFR part 178. Because the Postal Service 
has not experienced any significant problems with the test reports 
provided by the independent testing facilities, we do not feel there is 
a need to change the previously existing requirements for package 
testing. Additionally and as stated previously, the Postal Service will 
adopt new securing requirements for the outer shipping container to 
further reduce the potential for package failure during postal 
processing. The adoption of this requirement is directly related to 
specific instances of package failure that have occurred during postal 
handling.
    The institute also recommended the that Postal Service require the 
assembly instruction sheet for each sharps container system also 
include a customer service telephone number for the end user to call if 
they need assistance or find a component part is missing. Although the 
Postal Service did not include this requirement in the proposed rule, 
it will adopt a variation of it in this final rule. The adopted text 
will require that each assembly sheet for a sharp waste or regulated 
medical waste container system list a customer service telephone number 
or provide specific information on where such a telephone number is 
located elsewhere on the container system. The Postal Service does not 
feel this will present a hardship for mailers, since many already 
display a customer service phone number on their assembly instruction 
sheets. The adoption of this requirement will help provide one more 
support level to the third-party end user who is being relied on to 
properly assemble the container system before depositing it into the 
mail. Proper assembly of a sharps container system prior to mailing is 
critical to ensuring it will be safely handled and transported without 
deterioration or package failure.
    The institute further recommended that the Postal Service 
discontinue the use of the term ``waste manifest'' in the requirements 
that apply to the mailing of sharps waste and replace the term with 
``shipping paper.'' The Postal Service did not propose this change and 
feels it is unnecessary. The text in DMM C023.8.7c(3) states that the 
waste manifest serves as the shipping paper. In addition, such a change 
could pose a hardship for regulated medical waste and sharps waste 
mailers who presently identify this document as a waste manifest, by 
causing them to incur the cost for redesigning and replacing the 
documents.

4. Comments Supporting the Proposed Changes

    Seven of the commenters, including three sharps mailers, two 
medical labs, the institute, and the law firm, submitted comments that 
supported some of the requirements in the Postal Service proposed rule. 
Those comments are summarized in this section.
    Two of the sharps mailers stated that they did not oppose the 
Postal Service proposal to limit the maximum weight of a mailpiece 
containing regulated medical waste or sharps waste to 25 pounds. 
Another further stated that, in

[[Page 33862]]

general, they supported the Postal Service proposed rule.
    One medical lab stated they were pleased with the Postal Service 
changes that would improve packaging integrity and they supported them. 
The commenter further stated that they approved of the text in DMM 
C023.8.10a that included the phrase ``* * * for drug testing programs 
or for insurance purposes * * *'' within the definition of the term 
diagnostic (clinical) specimen. The commenter stated that the slightly 
stricter packaging requirements would help to ensure their receipt of 
safely packaged specimens.
    Three commenters, including one medical lab, the institute, and the 
law firm, supported the Postal Service effort to align the mailing 
standards with the DOT regulations in 49 CFR. These commenters felt 
that harmonization of the packaging requirements among all agencies and 
regulators would be a positive benefit for all mailers and shippers.
    The institute also stated that they recognized and supported the 
continued role of the Postal Service in providing mailing options for 
senders of infectious substances and mail-back systems.
    One medical lab stated they appreciated the Postal Service proposal 
to provide specific packaging requirements for dry specimens. They 
further noted they supported the development of mailing standards that 
benefit both the industry and the Postal Service.

Part C--Summary of Changes

    In this final rule, the Postal Service adopts the following changes 
to the mailing standards in DMM C023.8.0 for Division 6.2 infectious 
substances:
    [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 International Civil Aviation 
Organization (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, in some instances the 
Postal Service volume limits are lower than the DOT limits.
    [sbull] New DOT Federal requirements that regulate diagnostic 
(clinical) specimens in Risk Groups 2, 3, or 4 as hazardous materials.
    [sbull] New DOT Federal requirements that do not regulate certain 
Risk Group 1 materials, including diagnostic (clinical) specimens, as 
hazardous materials.
    [sbull] Revisions and modifications in the DOT Federal regulations 
related to the definitions of Division 6.2 materials and clarification 
of the use of the biohazard symbol on regulated and nonregulated 
material.
    In addition, the Postal Service is adopting a few minor 
clarifications and changes to the hazardous materials standards in DMM 
C023 and certain related standards in DMM C021, C023, C024, C050, and 
F010. These changes will improve clarity in the standards and reduce 
misunderstandings. They will also improve packaging integrity for 
mailable types of regulated medical waste and sharps waste, and provide 
a greater level of safety during handling for both Postal Service 
employees and the public. These 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[reg], Priority 
Mail[reg], and Express Mail[reg] destined to zones 5 through 8; 
however, air transportation service 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 requirements in DMM C023.8.0 to establish 
that mailable types of regulated medical waste are subject to the same 
authorization requirements as sharps waste.
    [sbull] Clarifications and minor changes to the requirements in DMM 
C023.8.0 for regulated medical waste and sharps waste containers to 
enhance the accuracy of the regulations and reduce misunderstanding of 
the standards. In addition, the Postal Service adopts additional 
limitations for regulated medical waste and 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] Standardization of the maximum weight limit in DMM C023 for 
several different types of mailable hazardous materials as 25 pounds or 
less. This change affects nonflammable compressed gases, matches, 
regulated medical waste, sharps waste, 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. Additional clarifying text is also added to DMM C050.2.2d.
    [sbull] Revisions to DMM F010 that 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 hazardous materials under DMM C023. Also, a 
revision to require a return or forwarding endorsement on Standard Mail 
containing mailable hazardous materials.
    These changes are effective June 12, 2003. However, mailers are 
provided with a phase-in period through January 1, 2004, for 
implementation of the new packaging requirements for diagnostic 
specimen mailpieces using a business reply mail format and medical 
waste mailpieces (including sharps waste) using a merchandise return 
service format. This time period will allow mailers to exhaust any 
existing packaging stock already in circulation.
    The Postal Service believes that the adoption of the changes in 
this final rule will help to ensure an acceptable level of security and 
safety during Postal Service handling for the limited types and 
quantities of hazardous materials that are permitted in the U.S. mail.
    Based on the proposed rule, and after careful consideration of the 
comments received, as described above, the Postal Service adopts the 
following changes to the Domestic Mail Manual, which are 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]

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


0
2. Revise the following sections of the Domestic Mail Manual (DMM) as 
follows:

Domestic Mail Manual (DMM)

* * * * *

C Characteristics and Content

C000 General Information

* * * * *

[[Page 33863]]

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

    Except as provided in this document, any article, composition, or 
material is nonmailable if it can kill or injure another or injure the 
mail or other property. Harmful matter includes but is not limited to:
* * * * *
    [Revise item b to read as follows:]
    b. All poisonous animals except scorpions mailed for medical 
research purposes or for the manufacture of 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

    The following conditions apply:
    [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 does 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 current 1.3 through 1.9 as new 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.'']
* * * * *

[[Page 33864]]

1.6 Mailability Rulings

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

1.7 Warning Labels

    [Change ``division 6.2 materials under 8.3'' to ``Division 6.2 
materials under 8.5'' and ``as required in 1.7'' to ``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 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 the requirements for air 
transportation. 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 gases 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 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.

[[Page 33865]]

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''.]

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

    The materials covered under Division 6.2 include 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 Groups 2, 3, or 4 must be prepared to meet the 
requirements for air transportation.

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 
part 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 part 102 (Licenses for 
Biological Products); 9 CFR part 103 (Experimental Products, 
Distribution, and Evaluation of Biological Products Prior to 
Licensing); 9 CFR part 104 (Permits for Biological Products); 21 CFR 
part 312 (Investigational New Drug Application); 21 CFR part 314 
(Applications for FDA Approval to Market a New Drug); 21 CFR part 600-
680 (Biologics); or 21 CFR part 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, for USPS purposes, means a soft 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. 
Soft medical waste includes items such as

[[Page 33866]]

used rubber gloves, swabs, gauze, tongue depressors, etc. Regulated 
medical waste classified in Risk Group 4 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. 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. The sender 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 serious human or  High..................  High.
                  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.
3..............  A pathogen that usually causes serious human or  High..................  Low.
                  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 or animal        Moderate..............  Low.
                  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 to cause human  None or Very Low......  None or Very Low.
                  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, for USPS purposes, 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, regulated medical waste, or sharps waste, is contaminated with 
potentially infectious body fluids or materials, and is not 
decontaminated or disinfected to remove or mitigate the infectious 
hazard prior to 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.
    f. Environmental microbiological samples, such as samples of dust 
from a ventilation system or mold from a wallboard, collected to 
evaluate occupational and residential exposure risks.

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.

[[Page 33867]]

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 Waste...................................................        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--nonmailable.
n/a--not applicable.

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. 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 normal handling, and if the total volume of the 
material in all enclosed primary receptacles does not exceed 50 ml for 
liquids or 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. All mailpieces sent under 8.5 must be sent First-Class Mail or 
Priority Mail and 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. Any mailpiece classified as a Risk Group 4 material and that 
contains any of the select agents or toxins listed in 42 CFR 73.4 or 
73.5 must meet all requirements in 42 CFR 72 and must also be sent 
using Registered Mail service.
    g. Articles that include dry ice as a refrigerant for the 
infectious substance must meet the requirements in 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, Priority Mail, or Express 
Mail. Such materials must be packaged in a triple packaging, consisting 
of a primary receptacle, secondary container, and outer shipping 
container, subject to the following specific requirements:
    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 with 
sufficient cushioning material to withstand shock and pressure changes 
and with absorbent material capable of taking up the entire liquid 
contents should 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.
    (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. The secondary container must be marked with 
the international biohazard symbol as shown in Exhibit 8.7c(2).
    (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

[[Page 33868]]

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 (or Dried) Diagnostic Specimens.
    (1) The primary receptacle must be siftproof with a capacity of not 
more than 500 g (1.1 pounds).
    (2) If several fragile primary receptacles are placed in a single 
secondary container, they must be individually wrapped or separated 
with sufficient cushioning material to prevent contact between them. 
The secondary container must be siftproof to contain the contents 
should the primary receptacle(s) leak. The secondary container must be 
marked with the international biohazard symbol as shown in Exhibit 
8.7c(2).
    (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 Sharps Waste and Other Mailable Regulated Medical 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 container system 
(including all component parts required to safely mail 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 container system must be tested and certified under the 
standards in 8.7d by an independent testing facility. The manufacturer 
or distributor in whose name the authorization is being sought must 
submit a written request to the manager, Mailing Standards, 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 
waste container systems 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 container systems to be covered by 
the request, a complete sample of each mailing container system, 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 waste manifest (i.e., shipping paper) to 
be used with each mailing container system.
    (6) 24-hour toll free telephone number for emergencies.
    (7) List of the types of waste to be mailed for disposal in each 
mailing container system.
    (8) Copy of the merchandise return service label to be used with 
each mailing container system.
    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 meeting the 
definitions in 8.2e and 8.2g, respectively, must be collected in a 
rigid, securely sealed, and leakproof primary receptacle. For sharps 
waste, the primary receptacle must also be puncture-resistant and may 
not have a maximum capacity that exceeds 3 gallons in volume. For 
regulated medical waste, the primary receptacle may not have a maximum 
capacity that exceeds 5 gallons in volume. Each primary receptacle may 
not contain more than 50 ml (1.66 ounces) of residual waste liquid. 
Each primary receptacle must display the international biohazard symbol 
shown in Exhibit 8.7c(2). Each 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 mil 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. The primary 
receptacle(s) must fit securely and snugly within the secondary 
container to prevent breakage during ordinary processing.
    (3) The secondary container must be enclosed in a strong outer 
shipping container constructed of 200-pound grade corrugated 
fiberboard. 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 unless reinforced with water-resistant tape. The 
secondary container must fit securely and snugly 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 container system, the authorized manufacturer 
or distributor must include a step-by-step instruction sheet that 
clearly details the proper sequence and method of container system 
assembly prior to mailing to prevent package failure during transport 
due to improper assembly. The instruction sheet must also include a 
customer service telephone number, or provide specific information on 
where such a telephone number is located elsewhere on the container 
system, for third-party end users to contact if they have assembly 
questions or find a component part is missing.
    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, and; (c) 
the container ID number (or unique model number) signifying that the

[[Page 33869]]

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).
[GRAPHIC] [TIFF OMITTED] TR06JN03.014

    (3) Each mailpiece must have a four-part waste manifest, which also 
serves as the 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 container system 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 of.
------------------------------------------------------------------------
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 USC 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.
------------------------------------------------------------------------

[[Page 33870]]

 
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 authorized 
medical waste mailer.
    (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 by an independent 
testing facility on one sample of each type of mailing container system 
to prove compliance with 8.7a. The sample mailing container system 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 container system 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 whenever a change is made to the design of the container 
system or every 24 months, whichever occurs first.

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, Priority Mail, or Express 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, Priority Mail, or Express Mail when 
packaged in a triple packaging, consisting of a primary receptacle, 
secondary container, and outer shipping container as follows:
    a. 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).
    b. The primary receptacle and the absorbent and cushioning material 
must be enclosed in a watertight and securely sealed secondary 
container. The secondary container must also display the international 
biohazard symbol as shown in Exhibit 8.7c(2).
    c. The secondary container must be firmly and snugly packed within 
a strong outer shipping container that is securely sealed. A shipping 
paper and a content 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, Express 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. 
Either the primary receptacle or the inner packaging must be marked 
with the international

[[Page 33871]]

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 in Risk Group 1 (e.g., a urine 
specimen or blood specimen used in drug-testing programs or for 
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. 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) should leak during transport. The 
secondary container must be securely sealed and it may serve as the 
outer shipping container provided it has sufficient strength to 
withstand ordinary postal processing. The secondary container must be 
marked with the international biohazard symbol as shown in Exhibit 
8.7c(2), except when the secondary packaging 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. A shipping 
paper and a content marking on the outer shipping container are not 
required.
    (2) Exceeding 50 ml. A clinical specimen 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 having 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 as shown in 
Exhibit 8.7c(2). 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. The maximum amount of a 
specimen that may be enclosed in a single mailpiece must not exceed 
4,000 ml. A shipping paper and a content marking on the outer shipping 
container are not required.
    b. Solid (or Dried) Specimens. A solid or dry specimen, such as a 
saliva swab, blood spot, or fecal smear in Risk Group 1 must be 
completely dried prior to placing it in or on a secure primary 
receptacle. Cushioning material to withstand shock and pressure changes 
is only required if the dry specimen is held in a breakable primary 
receptacle. 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 must 
be securely sealed and it may serve as the outer shipping container 
provided it has sufficient strength to withstand ordinary postal 
processing. The secondary container must be marked with the 
international biohazard symbol as shown in Exhibit 8.7c(2), except when 
the secondary packaging 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. 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 
containers''; 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, remove ``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 current 11.5 as new 12.0 to read as follows:]

[[Page 33872]]

12.0 OTHER REGULATED MATERIALS--MAGNETIZED MATERIALS
    [Change the introductory paragraph in new 12.0 to read as follows 
(the remainder of new 12.0 is unchanged):]
    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 in item a, change ``a hazard class 9 
material'' to ``a hazardous material.'']
    b. Mailability.
    [In the third sentence in item b, change ``Publication 52'' to 
``Publication 52, Hazardous, Restricted, and Perishable Mail.'']
* * * * *

C024 Other Restricted or Nonmailable Matter

* * * * *

    [Renumber current 18.0 and 19.0 as new 19.0 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 sent at the First-Class Mail or Standard 
Mail nonautomation rates may be subject to the nonmachinable surcharge 
under E130 or E620, as applicable. Certain types of odd-shaped items, 
when properly wrapped, are permitted as automation rate letter-size 
mail subject to the standards in C810. Flat-size automation rate mail 
is subject to the uniform thickness requirement in C820.
* * * * *

C050 Mail Processing Categories

* * * * *
2.0 LETTER-SIZE MAIL
* * * * *

2.2 Nonmachinable Criteria

    A letter-size piece is nonmachinable if it has one or more of the 
following characteristics (see C010.1.3 to determine the length, 
height, top, and bottom of a mailpiece):
* * * * *
    [Revise item d by adding a reference to C024.18.0 to read as 
follows:]
    d. Contains items such as pens, pencils, or loose keys or coins 
that cause the thickness of the mailpiece to be uneven (see C024.18.0).
* * * * *

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. ``Change Service Requested'' is not permitted for the following:
    (1) Priority Mail, other than Priority Mail containing perishable 
matter under C022 (except for live animals).
    (2) First-Class Mail or Priority Mail containing hazardous 
materials under C023.
    (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''    Option 1 \2\
 \2\.                           In all cases (regardless of whether a
                                 change-of-address order is on file):
                                 Separate notice of new address or
                                 reason for nondelivery provided (in
                                 either case, address correction fee
                                 charged); piece disposed of by USPS.
                                Option 2 \2\
                                If no change-of-address order on file:
                                 Piece disposed of by USPS; separate
                                 notice of reason for nondelivery
                                 provided (address correction fee
                                 charged).
                                If change-of-address order on file:
                                Months 1 through 12: piece forwarded (no
                                 charge); separate notice of new address
                                 provided (address correction fee
                                 charged).
                                Months 13 through 18: piece disposed of
                                 by USPS; separate notice of new address
                                 provided (address correction fee
                                 charged).
                                After month 18: piece disposed of by
                                 USPS; separate notice of reason for
                                 nondelivery provided (address
                                 correction fee charged).
                                Restrictions (for Options 1 and 2): The
                                 following restrictions apply:
                                (1) This endorsement is limited to use
                                 on valid mailpieces bearing a proper
                                 ACS participant code and only for: (a)
                                 Priority Mail containing perishable
                                 matter (other than live animals) and
                                 the marking ``Perishable'' and; (b)
                                 First-Class Mail (excluding hazardous
                                 materials).
                                (2) Delivery Confirmation and Signature
                                 Confirmation are the only special
                                 services permitted with this
                                 endorsement.
 
                              * * * * * * *
------------------------------------------------------------------------


* * * * *
    [Revise the text of footnote 2 to read as follows:]
    2. Valid only for ACS participating pieces (subject to F030) other 
than pieces containing hazardous materials.
* * * * *

5.3 Standard Mail

* * * * *

[[Page 33873]]

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

Exhibit 5.3a Treatment of Undeliverable Standard Mail

    [Revise the listings for ``No endorsement'', ``Address Service 
Requested'', and ``Change Service Requested'' to read as follows:]

------------------------------------------------------------------------
      Mailer endorsement              USPS treatment of UAA pieces
------------------------------------------------------------------------
No endorsment \1\.............  In all cases: Piece disposed of by USPS.
                                Restrictions: Standard Mail containing
                                 hazardous materials must bear a
                                 permissible endorsement (see 5.3e).
``Address Service Requested''   * * * * *
 \2\.
 
                              * * * * * * *
``Change Service Requested''    In all cases: Separate notice of new
 \1,\\3\.                        address or reason for nondelivery
                                 provided (in either case, address
                                 correction fee charged); piece disposed
                                 of by USPS.
                                Restrictions: The following restrictions
                                 apply:
                                (1) Delivery Confirmation is the only
                                 special service permitted with this
                                 endorsement.
                                (2) This endorsement is not permitted
                                 for Standard Mail containing hazardous
                                 materials.
------------------------------------------------------------------------

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

5.4 Package Services

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

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''    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: The following restrictions
                                 apply:
                                (1) Delivery Confirmation and Signature
                                 Confirmation are the only special
                                 services permitted with this
                                 endorsement.
                                (2) This endorsement is not permitted
                                 for Package Services Mail containing
                                 hazardous materials.
------------------------------------------------------------------------

* * * * *
    [Add new footnote 2 to read as follows:]
    2. Not valid for pieces containing hazardous materials. Valid for 
all other pieces, including ACS participating pieces.
* * * * *
    An appropriate amendment to 39 CFR part 111 to reflect these 
changes will be published.

Neva Watson,
Attorney, Legislative.
[FR Doc. 03-14185 Filed 6-5-03; 8:45 am]
BILLING CODE 7710-12-P