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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

Section Subject
173.134 Class 6, Division 6.2-Definitions and exceptions