[Federal Register Volume 85, Number 83 (Wednesday, April 29, 2020)]
[Rules and Regulations]
[Pages 23745-23746]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08256]


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POSTAL SERVICE

39 CFR Part 113


New Mailing Standards for COVID-19 Related Category B Infectious 
Substances

AGENCY: Postal ServiceTM.

ACTION: Temporary final rule.

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SUMMARY: The Postal Service is revising its Hazardous, Restricted and 
Perishable Mail regulations by replacing Publication 52, Hazardous, 
Restricted, and Perishable Mail, Appendix C, Packaging Instructions 6C, 
currently incorporated by reference, to support the rapid deployment of 
coronavirus (COVID-19) diagnostic tests using the mail during this 
public health emergency. In addition to the updated packaging 
instructions, all shippers of COVID-19 related Infectious Substances 
Category B UN3373 must obtain authorization from the Postal Service 
prior to mailing. These measures are necessary to ensure that 
diagnostic kits potentially containing Category B Infectious Substances 
are packaged, marked and labelled properly to ensure safety and 
containment throughout transport.

DATES: Effective: April 27, 2020 until the Federal public health 
emergency first declared on March 13, 2020 is terminated (following 
procedures prescribed in 50 U.S. Code Sec.  1622). The Postal Service 
will publish a document announcing the termination date in the Federal 
Register.

FOR FURTHER INFORMATION CONTACT: Mary J. Collins at (202) 268-5551 or 
Dale Kennedy at (202) 268-6592 or by email at 
[email protected].

SUPPLEMENTARY INFORMATION:

Overview

    The United States Postal Service is currently experiencing a 
greater demand for the transportation of Infectious Substances, 
Category B UN3373 as a result of the ongoing COVID-19 pandemic. Due to 
the infectious nature of these materials, there exists a need for 
higher levels of awareness, safety and compliance in order to protect 
our employees, customers, and transportation partners.
    When a package containing infectious substances is moved between 
the point of origin and its destination, it may be subjected to 
physical challenges, including movement, vibration, and changes of 
temperature, humidity and pressure. It is therefore, essential that the 
packaging used to contain infectious substances meets all required 
standards, and is able to withstand the normal conditions of 
transportation. It is the responsibility of the shipper to ensure they 
comply with all applicable regulations. The revisions will provide 
conformity and harmonization with other regulatory entities, prevent 
the shipment of fraudulent test kits in the mail, and reduce risk to 
employees and the general public by preventing exposure to this 
infectious substance.
    The current packaging requirements incorporated by reference in 
Publication 52 Appendix C, Packaging Instruction 6C are replaced with 
new required shipper authorization and updated packaging requirements 
added as Sec.  113.3. Section 113.3 will be in place until the end of 
this public health emergency.
    The Postal Service will publish a document announcing the 
termination date in the Federal Register. If you want to know whether 
this rule has been terminated, email or call either person identified 
in FOR FURTHER INFORMATION CONTACT.
    The specific requirements to be used in place of Appendix C, 
Packaging Instruction 6C to Publication 52, Hazardous, Restricted, and 
Perishable Mail adopted in this document will be published in Postal 
Bulletin 22544 on April 23, 2020, and can be viewed at http://about.usps.com/postal-bulletin.

List of Subjects in Part 113

    Administrative practice and procedure, Postal Service.

    For the reasons set forth above, the Postal Service amends 39 CFR 
part 113 as follows:

PART 113--HAZARDOUS, RESTRICTED, AND PERISHABLE MAIL

0
1. The authority citation for part 113 continues to read as follows:

    Authority: 5 U.S.C. 552(a); 13 U.S.C. 301-307; 18 U.S.C. 1692-
1737; 39 U.S.C. 101, 401, 403, 404, 414, 416, 3001-3011, 3201-3219, 
3403-3406, 3621, 3622, 3626, 3632, 3633, and 5001.


0
2. Amend Sec.  113.1 by adding a final sentence to read as follows:


Sec.  113.1  Scope and purpose.

    * * * Follow the requirements of Sec.  113.3 in place of 
Publication 52, Appendix C, Packaging Instruction 6C.

0
3. Add Sec.  113.3 to read as follows:


Sec.  113.3  Mailing Standards for COVID-19 related Category B 
Infectious Substances.

    (a) Required Shipper Authorization. (1) All shippers of COVID-19 
related Infectious Substances Category B must obtain an authorization 
from the Postal Service prior to mailing. It is the responsibility of 
the shipper to ensure that they are aware of, and comply with, all 
other applicable requirements and regulations for the mailing of these 
materials; and they must be able to provide evidence of compliance 
before a written request is submitted to the manager of Product 
Classification, Postal Service Headquarters.
    (2) Under this section, only tests developed and being performed by 
laboratories certified under the Clinical Laboratory Improvement 
Amendments (CLIA) or equivalent clinical oversight regulations, and 
commercial tests and home collection kits authorized by

[[Page 23746]]

either the FDA or an Institutional Review Board will be considered for 
mailing.
    (b) Required Packaging. The materials must be triple-packaged, 
meeting the packaging requirements in 49 CFR 173.199. Such materials 
must be properly packaged to withstand shocks, pressure changes, and 
other conditions related to ordinary handling in transit, and 
surrounded by absorbent material sufficient to protect the primary 
receptacle and to absorb the total amount of liquid should the primary 
receptacle leak or break. The outer packaging must be of adequate size 
to accommodate all required shipping information and marks and will 
include the size of the mark on each side must not be less than 50 mm 
(1.97 inches) in length, the width of the border lines at least 2 mm, 
and letter and numbers must be at least 6 mm (0.24 inches) high.
    (c) Package Drop Test. The completed triple packaging must be 
capable of successfully passing the drop test in 49 CFR 178.609(d) at a 
drop height of at least 1.2 meters (3.9 feet). Following the drop test, 
there must be no leakage from the primary receptacle, which must remain 
protected by absorbent material, when required, in the secondary 
packaging.
    (d) Instructions. Shippers must provide clear instructions to users 
regarding the procedures to be followed for preparing the samples and 
packaging used to transport an Infectious Substance Category B. 
Shippers must instruct users to adhere to all applicable mail related 
preparation requirements before mailing, to ensure the package is 
properly prepared for safe transportation.
    (e) Optional Outer Packaging. A polybag covering may be acceptable 
as the outer packaging, providing that the interior triple packaging is 
complete, the selvage edge of the wrapping is less than 2 inches, all 
required markings and address information are applied both on the 
interior rigid box and the additional outer polybag wrapping.
    (f) Use of a Refrigerant (If Applicable). (1) Only cold packs or 
dry ice may be used as a refrigerant and must be placed outside of the 
secondary packaging. Interior supports must be provided to secure the 
secondary packaging in the original position. If a cold pack is used, 
the packaging must be leak-proof. If dry ice is used, the outside 
packaging must permit the release of carbon dioxide gas and otherwise 
meet the provisions in 49 CFR 173.217. The primary receptacle and 
secondary packaging must maintain their integrity at the temperature of 
the refrigerant used, as well as the temperatures and pressures of 
transport by aircraft they could be subjected to if refrigeration were 
lost, and sufficient absorbent material must be provided to absorb all 
liquid, including melted ice.
    (2) When dry ice is used, the package must include the markings 
``Carbon dioxide, solid'' or ``Dry ice'' and an indication that the 
material being refrigerated is used for diagnostic or treatment 
purposes (e.g., frozen medical specimens). Marking requirements in USPS 
Packaging Instruction 9A are not applicable.
    (g) Other Allowance. Only small quantities of Class 3, Class 8, 
Class 9, or other materials in Packing Groups II and III may be used to 
stabilize or prevent degradation of the sample, provided the quantity 
of such materials does not exceed 30 mL (1 ounce) or 30 g (1 ounce) in 
each inner packaging.

Joshua J. Hofer,
Attorney, Federal Compliance.
[FR Doc. 2020-08256 Filed 4-27-20; 11:15 am]
BILLING CODE 7710-12-P