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Interpretation Response #09-0186 ([Oregon Health and Science University] [Ms. Debra A. Brickey])

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

Interpretation Response Details

Response Publish Date:

Company Name: Oregon Health and Science University

Individual Name: Ms. Debra A. Brickey

Location State: OR Country: US

View the Interpretation Document

Response text:

September 4, 2009

 

 

 

Ms. Debra A. Brickey, PhD

Responsible Official Select Agent Program,

Central and Waterfront Campuses

Oregon Health and Science University, PP-170

3181 SW Sam Jackson Pk Rd

Portland, OR 97239-3098



Ref. No. 09-0186

Dear Dr. Brickey:

This responds to your June 31, 2009 email requesting an interpretation of the applicability of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) to the transport of Division 6.2 materials. Specifically, you ask whether mice infected with a replication defective adeno-associated virus (AAV) are subject to the requirements of the HMR.

The information attached to your email indicates that the mice are infected with a type of AAV that does not cause disease in humans or animals. The AAV injected into the mice is inactivated such that it does not replicate itself in the host; thus, the mice do not contain infectious AAV viral particles.

Under § 173.134, a Division 6.2 Infectious substance is defined as a material known to contain or reasonably expected to contain a pathogen, such as a virus, that can cause disease in humans or animals. Additionally, under exceptions provided in § 173.134(b), a material containing pathogens that have been neutralized or inactivated such that they no longer pose a health risk is not subject to the requirements of the HMR as a Division 6.2 material. Based on the information provided in your email, it is the opinion of this Office that the mice do not meet the definition of a Division 6.2 material and are not subject to the HMR.

I hope this information is helpful. If you have further questions, please contact this office.

Sincerely,

Charles E. Betts

Chief, Standards Development

Office of Hazardous Materials Standards

173.134(b)

Regulation Sections