Infectious substance means a material known or reasonably expected to contain a pathogen. A pathogen is a microorganism that can cause disease in humans or animals. Examples of pathogens include bacteria, viruses, fungi, and other infectious agents. An infectious substance must be assigned to one of the following two packaging categories:
- International Mail: Mailable when they meet the definition in 346.12a2 and IMM 135 when written approval has been granted by the manager of Product Classification. Category B infectious substances may be sent with registered First-Class Package International Service or the Priority Mail International Small Flat Rate Priced Boxes using Registered Mail service.
- Domestic Mail: Mailable only when they are intended for medical or veterinary use, research, or laboratory certification related to the public health, and when such materials are properly prepared for mailing to withstand shocks, pressure changes, and other conditions related to ordinary handling in transit. Unless otherwise noted, all mailable Division 6.2 materials must meet the mail preparation requirements for air transportation and sent with First-Class Mail, Priority Mail, or Priority Mail Express service.
As required by 49 CFR 173.199:
- Substances identified in IMM 135.11b must be sent only by authorized laboratories to their foreign counterparts in those countries that have indicated a willingness to accept them.
Note: Countries distinguish between infectious and noninfectious (nonregulated) biological substances and may prohibit one or the other or both. See “Prohibitions” in the Individual Country Listings.
- Laboratories of local, state, and federal government agencies.
- Laboratories of federally licensed manufacturers of biological products derived from bacteria and viruses.
- Laboratories affiliated with or operated by hospitals, universities, research facilities, and other teaching institutions.
- Private laboratories licensed, certified, recognized, or approved by a public authority.