Solstice Neurosciences — Hazardous Materials Safety Interpretation

Page 1U.S. Department of Transportation 1200 New Jersey Ave, SE Washington, D.C. 20590 Pipeline and Hazardous Materials JAN 1 2 2011 Safety Administration 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 emailed a copy ofthe product's test rep011 (Report No. 09D0529G-XOIG, 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 detenninations 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, r-~//L'V~ T. Glenn Foster Chief, Regulatory Review and Reinvention Branch Standards and Rulemaking Division#

Page 2Drakeford. Carolyn (PHMSA) From: INFOCNTR (PHMSA) Sent: Wednesday, July 01, 2009 9:39 AM To: Drakeford, Carolyn (PHMSA) Subject: FW: Hazmat Information Center Feedback: Hazardous Materials Table, Special ProviSions, Hazardous Materials Communications Me11\..-kJ re.. ~ '12.· 16 l -----Original Message-----~ (13.13;>... Sent: Tuesday, June 30, 2009 4:15 PM From: PHMSA-Feedback [mailto:PHMSA-Feedback] Appl iced;;, ';Y To: PHMSA HM InfoCenter; PHMSA Webmaster 0'1-0 I Subject: Hazmat Information Center Feedback: Hazardous Materials Table, Special Provisions, Hazardous Materials Communications Mr. Edward T. 1'1azzullo, I am requesting clarification of the designation we have assigned to our licensed product under the Hazardous Materials Regulations (HMR; 49 CFR 171-180). According to 49 CFR 172.101 our product meets the definition of a hazardous material as it is listed on the table as: Toxins, extracted from living sources, liquid,n.o.s. with a hazard class of 6.1. However, our toxicit results are outside the parameters of the tables in 49 CFR 173.133 and therefore we bel it does not meet the criter~a to be classified as a hazardous material. Do you agree with our conclusion that this material ~s not classified as a hazardous material under 49CFR 171-180? Thank you, David Schaper Sr. Manager EHS Solst~ce Neurosciences 701 Gateway Blvd., Suite 250 S. San Francisco, CA 94080 650-291-8206 david.schaper@solsticeneuro.com Name: David Schaper Organization: Solstice Neurosciences Email: david.schaper@solsticeneuro.com Address: 701 Gateway Blvd. Suite 250 : South San Francisco Code: 94080 Phone: 650-291-8206 FAX: 650-243-4478 1#