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Interpretation Response #09-0102 ([Inmark, Inc.] [Mr. Junius Johnson])

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

Interpretation Response Details

Response Publish Date:

Company Name: Inmark, Inc.

Individual Name: Mr. Junius Johnson

Location State: GA Country: US

View the Interpretation Document

Response text:

May 5, 2009

 

 

Mr. Junius Johnson

Regulatory Compliance Manager

Inmark, Inc.

675 Hartman Road, Suite 100

Austell, GA 30168

Reference No. 09-0102

Dear Mr. Johnson:

This is in response to your April 29, and April 30, 2009 e-mails asking for clarification of the classification and packaging requirements for the swine flu virus under the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). Specifically, you ask if the swine flu virus must be classed as a Category A infectious substance during a pandemic. You also ask if a specimen, regardless of whether or not it is infectious, must be classed as a Category A infectious substance if it is collected from a region where a pandemic is occurring.

Based on information we received from the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO), it is our understanding that human and animal specimen samples known or suspected of containing the swine flu virus or a Category B infectious substance must be transported under the proper shipping description "UN 3373, Biological substance, Category B, 6.2." Such samples must be transported in conformance with the requirements prescribed in § 173.199 of the HMR. Cultures of the swine flu virus, cultures of certain other Category B infectious substances, and Category A infectious substances must be transported under the shipping description "UN 2814, Infectious substances, affecting humans, 6.2," or "UN 2900, Infectious substances, affecting animals, 6.2," as appropriate. Swine flu cultures must be transported in conformance with the requirements prescribed in § 173.196.

Note that for purposes of the HMR a culture is defined as an infectious substance containing a pathogen that has been intentionally propagated. The term does not include patient specimens collected directly from humans or animals and transported for diagnosis, research, or investigational purposes. Please see the definitions in § 173.134.

I hope this satisfies your request. Please feel free to contact me if you have questions or need additional information.

Sincerely,

 

Susan Gorsky

Regulations Officer

Office of Hazardous Materials Standards

173.196. 173.199

Regulation Sections

Section Subject
173.196 Category A infectious substances
173.199 Category B infectious substances