Interpretation Response #09-0151 ([Solstice Neurosciences] [Mr. David Schaper])
Below is the interpretation response detail and a list of regulations sections applicable to this response.
Interpretation Response Details
Response Publish Date:
Company Name: Solstice Neurosciences
Individual Name: Mr. David Schaper
Location State: CA Country: US
View the Interpretation Document
Response text:
January 12, 2011
Mr. David Schaper
Senior Manager Environmental Health and Safety
Solstice Neurosciences
701 Gateway Boulevard, Suite 250
South San Francisco, CA 94080
Reference No. 09-0151
Dear Mr. Schaper:
This is in response to your e-mail to this Office, and telephone conversation with a member of my staff, requesting clarification of the requirements for determining if your company"s licensed drug product, "Myobloc," a dilute Type B botulism toxin, meets the definition of a Division 6.1 (poisonous) hazardous material under the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). We apologize for the delay in responding and any inconvenience this may have caused.
According to your e-mail, you state the drug product may be best described as "UN 3172, Toxins extracted from living sources, liquid, n.o.s.," but your company"s toxicity test results for this material are outside the parameters prescribed in § 173.133 of the HMR for a Division 6.1 material. You also e-mailed a copy of the product"s test report (Report No. 09D0529G-X01G, dated June 4, 2009) that states the product "produced no mortality or toxic signs."
As specified in § 173.22, it is the shipper's responsibility to properly class and describe a hazardous material. Such determinations are not required to be verified by this office. However, based on the information you provided, it is our opinion that the product does not meet the definition of a Division 6.1 material under the HMR. If the material does not meet any other hazard class definition, the tested material is not subject to the HMR and not regulated for purposes of the transportation of hazardous materials in commerce. Please note, a shipping name from the Hazardous Materials Table (§ 172.101), such as "Toxins extracted from living sources, liquid, n.o.s.," may be used to describe a non-hazardous material provided neither the hazard class or identification number (UN or NA) are used in the description. See §§ 172.202(e) and 172.303(b)(3).
I hope this satisfies your request.
Sincerely,
T. Glenn Foster
Chief, Regulatory Review and Reinvention Branch
Standards and Rulemaking Division
173.133, 173.22