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Interpretation Response #19-0032

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

Interpretation Response Details

Response Publish Date:

Company Name: Locus Biosciences, Inc.

Individual Name: Nick Conley

Location State: NC Country: US

View the Interpretation Document

Response text:

May 23, 2019

Nick Conley, PhD
Principal Scientist
Locus Biosciences, Inc.
523 Davis Drive, Ste. 350
Morrisville, NC 27560

Reference No. 19-0032

Dear Dr. Conley:

This letter is in response to your March 6, 2019, email requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to classification of a specific strain of E. coli bacteria. Specifically, you ask whether a culture of non-pathogenic E. coli that is believed to be not capable of causing disease in humans is subject to the HMR.

The HMR defines a Division 6.2 material in § 173.134 as a material known to contain or suspected of containing a pathogen. A pathogen is a microorganism (including bacteria, viruses, rickettsiae, parasites, fungi) or other agent, such as a proteinaceous infectious particle (prion) that can cause disease in either humans or animals. In accordance with § 173.22, it is the shipper's responsibility to properly class and describe a hazardous material. This Office does not perform that function. If your material consists wholly of microorganisms that cannot cause disease in either humans or animals, and does not meet the definition of any other class of hazardous material, then it is not subject to the HMR.

I hope this information is helpful. Please contact us if we can be of further assistance.

Sincerely,

Dirk Der Kinderen
Chief, Standards Development Branch
Standards and Rulemaking Division

173.134, 173.22

Regulation Sections

Section Subject
173.134 Class 6, Division 6.2-Definitions and exceptions
173.22 Shipper's responsibility