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UN3373 Packaging Regulations – US Postal Service Amend Mail Regulations

4 May 2020 | Industry News & Regs

The US Postal Service have released new (temporary) guidelines for shipping Category B Infectious Substances via mail.

To support the increased deployment of COVID-19 diagnostic tests via mail, the US Postal Service has revised its Hazardous, Restricted and Perishable Mail regulations replacing Publication 52, Hazardous, Restricted and Perishable Mail, Appendix C, Packaging Instructions 6C, effective from 27th April.

As the requirement for sending COVID-19 specimen samples via mail increases and due to the infectious nature of COVID-19, it is vital that these specimens are packaged correctly when being shipped from one destination to another. It is essential that shippers are aware of the regulations surrounding the transportation of Category B Infectious Substances, as it is their responsibility to ensure any substances of this nature sent via mail are packaged correctly.

During transit the package can be subject to vibration, shock, pressure changes and other variables. If incorrectly packaged, leakages can occur resulting in a risk of exposure to postal service employees and the general public, therefore Category B Infectious Substances must be packaged, marked and labelled properly to ensure containment throughout transport.

The new Hazardous, Restricted and Perishable Mail regulations provides a detailed account of how to compliantly package Category B Infectious Substances for shipment via mail.

We have provided a basic summary of the guidelines below:

  • Shippers must obtain authorization from the Postal Service prior to mailing and will be required to provide evidence of compliance.
  • Only tests developed and being performed by laboratories certified under the CLIA or equivalent and commercial tests and home collection kits authorized by either the FDA or an Institutional Review Board will be considered for mailing.
  • The hazardous materials must be triple-packaged meeting the packaging requirements in 49 CFR 173.199 and must include absorbent material sufficient to both protect the primary receptacle and fully absorb any leakage.
  • The packaging used must be capable of passing the drop test in 49 CFR 178.609.
  • Instructions must be provided and adhered to for preparing samples and correctly assembling the package to ensure it is properly prepared for safe transportation.
  • Optional Outer Packaging, a polybag covering may be acceptable as the outer packaging, providing that the interior triple packaging is complete and labels can be applied as per regulations.
  • Only cold packs or dry ice may be used as a refrigerant and must be placed outside of the secondary packaging.
  • 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.

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