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 |