Effective April 23, 2020, the Postal Service™ is revising Publication 52, Hazardous, Restricted, and Perishable Mail, Appendix C, Packaging Instruction 6C, 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 before mailing.
These measures are necessary to ensure that diagnostic kits potentially containing Infectious Substances must be packaged, marked, and labeled properly to ensure safety and containment throughout transport.
Publication 52, Hazardous, Restricted, and Perishable Mail
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Appendix C — USPS Packaging Instructions for Mailable Hazardous Materials
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USPS Packaging Instruction 6C
Category B Infectious Substances
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Proper Shipping Name and ID Number
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Required Authorization
All shippers of COVID-19-related UN3373 Category B Infectious Substances must obtain an authorization from the Postal Service before 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 (see part 214 for address).
Under these provisions, only tests developed and 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 either the FDA or an Institutional Review Board, will be considered.
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Required Packaging
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n 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.
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Primary Receptacle (Container)
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n 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.
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Secondary Container
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Note: 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.
Outer Shipping Container
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n ***The outer packaging must be of adequate size to accommodate all required shipping information and marks.
n A poly mailer-type bag covering may be acceptable as the outer packaging provided triple packaging is complete, the selvage edge of the wrapping is less than 2 inches, and the required markings and address information are applied both on the interior rigid box and the additional outer polybag wrapping.
Markings
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n ***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 must be at least 2 mm, and letter and numbers must be at least 6 mm (0.24 inches) high.
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n 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). As this is the only information required with respect to global transportation regulations for dry ice included with UN3373 shipments, the requirements for dry ice as set forth in USPS Packaging Instruction 9A are not applicable.
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Documentation
Shippers must provide clear instructions to users, regarding the procedures to be followed for preparing the samples and packaging used to transport a Biological Substance UN3373 Category B. Specific to COVID-19, 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.
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Although effective April 23, 2020, the Postal Service will incorporate these revisions into the next edition of the online Publication 52, which is available via Postal Explorer® at pe.usps.com.
— Product Classification, Marketing, 4-23-20
