Infectious substances

March 20, 2018

Reference No. 17-0076

This letter is in response to your July 24, 2017, email requesting clarification of the Hazardous
Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to infectious substances. Specifically,
you currently offer for transportation two live viruses: 1) Vesicular stomatitis virus (Indiana), or VSV,
as a Category A infectious substance, and 2) Measles, as a Category B infectious substance. You ask
if the HMR provide any exceptions for biological products as defined in § 173.134(a)(2), and if so,
whether they may be used for live viruses stored for manufacturing purposes.

The answer to both of your questions is yes. As prescribed in § 173.134(b)(6), a biological product,
including an experimental or investigational product or component of a product, subject to Federal
approval, permit, review, or licensing requirements, such as those required by the Food and Drug
Administration of the U.S. Department of Health and Human Services or the U.S. Department of
Agriculture Animal and Plant Health Inspection Service (APHIS), is not subject to the requirements of
the HMR as a Division 6.2 material.

Since APHIS granted you a permit to import and transport the VSV, it is not subject to the
requirements of the HMR as a Division 6.2 material. However, because the Measles virus is not
subject to another Federal approval, permit, review, or licensing requirement, it is subject to the HMR
as a Division 6.2 material, and as a Category B infectious substance, it must be described as
“Biological substance, Category B” and assigned identification number “UN3373” for transportation in
commerce. Live viruses stored for manufacturing purposes are also eligible for the exceptions
provided by § 173.134 of the HMR.

I hope this information is helpful. Please contact us if we can be of further assistance.

Sincerely,

T. Glenn Foster
Chief, Regulatory Review and Reinvention Branch
Standards and Rulemaking Division

173.134(a)(2), 173.134(b)(6), 173.134