Interpretation Response #17-0076

Below is the interpretation response detail and a list of regulations sections applicable to this response.

Interpretation Response Details

Response Publish Date: 03/20/2018

Company Name: Vyriad

Individual Name: Jon Harrington

Country: US

View the Interpretation Document

Response text:

March 20, 2018

Mr. Jon Harrington
Director of Manufacturing Operations
Vyriad
221 1^st Avenue SW, Suite 102
Rochester, MN 55902

Reference No. 17-0076

Dear Mr. Harrington:

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

Regulation Sections