{"operation":"document","citation":"09-0151","title":"Solstice Neurosciences — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2011-01-12","effective_on":null,"summary":"09-0151 response to Solstice Neurosciences concerning 173.133, 173.22.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-09-0151.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-09-0151.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-09-0151","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretations/2009/090151.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department of Transportation 1200 New Jersey Ave, SE\nWashington, D.C. 20590\nPipeline and Hazardous Materials JAN 1 2 2011\nSafety Administration\nMr. David Schaper\nSenior Manager Environmental Health and Safety\nSolstice Neurosciences\n701 Gateway Boulevard, Suite 250\nSouth San Francisco, CA 94080\nReference No. 09-0151\nDear Mr. Schaper:\nThis is in response to your e-mail to this Office, and telephone conversation with a member of my staff,\nrequesting clarification of the requirements for determining if your company's licensed drug product,\n\"Myobloc,\" a dilute Type B botulism toxin, meets the definition of a Division 6.1 (poisonous)\nhazardous material under the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). We\napologize for the delay in responding and any inconvenience this may have caused.\nAccording to your e-mail, you state the drug product may be best described as \"UN 3172, Toxins\nextracted from living sources, liquid, n.o.s.,\" but your company's toxicity test results for this material\nare outside the parameters prescribed in § 173.133 of the HMR for a Division 6.1 material. You also emailed\na copy ofthe product's test rep011 (Report No. 09D0529G-XOIG, dated June 4,2009) that states\nthe product \"produced no mortality or toxic signs.\"\nAs specified in § 173.22, it is the shipper's responsibility to properly class and describe a hazardous\nmaterial. Such detenninations are not required to be verified by this office. However, based on the\ninformation you provided, it is our opinion that the product does not meet the definition of a Division\n6.1 material under the HMR. If the material does not meet any other hazard class definition, the tested\nmaterial is not subject to the HMR and not regulated for purposes of the transportation of hazardous\nmaterials in commerce. Please note, a shipping name from the Hazardous Materials Table (§ 172.101),\nsuch as \"Toxins extracted from living sources, liquid, n.o.s.,\" may be used to describe a non-hazardous\nmaterial provided neither the hazard class or identification number (UN or NA) are used in the\ndescription. See §§ 172.202(e) and 172.303(b)(3).\nI hope this satisfies your request\nSincerely,\nr-~//L'V~\nT. Glenn Foster\nChief, Regulatory Review and Reinvention Branch\nStandards and Rulemaking Division\n\n<<<PAGE 2>>>\n\nDrakeford. Carolyn (PHMSA)\nFrom: INFOCNTR (PHMSA)\nSent: Wednesday, July 01, 2009 9:39 AM\nTo: Drakeford, Carolyn (PHMSA)\nSubject: FW: Hazmat Information Center Feedback: Hazardous Materials Table, Special ProviSions,\nHazardous Materials Communications Me11\\..-kJ re..\n~ '12.· 16 l\n-----Original Message-----~ (13.13;>...\nSent: Tuesday, June 30, 2009 4:15 PM \n From: PHMSA-Feedback [mailto:PHMSA-Feedback]\nAppl iced;;, ';Y\nTo: PHMSA HM InfoCenter; PHMSA Webmaster 0'1-0 I\nSubject: Hazmat Information Center Feedback: Hazardous Materials Table, Special\nProvisions, Hazardous Materials Communications\nMr. Edward T. 1'1azzullo,\nI am requesting clarification of the designation we have assigned to our licensed\nproduct under the Hazardous Materials Regulations (HMR; 49 CFR 171-180).\nAccording to 49 CFR 172.101 our product meets the definition of a hazardous material as it\nis listed on the table as: Toxins, extracted from living sources, liquid,n.o.s. with a\nhazard class of 6.1.\nHowever, our toxicit results are outside the parameters of the tables in 49 CFR 173.133\nand therefore we bel it does not meet the criter~a to be classified as a hazardous\nmaterial.\nDo you agree with our conclusion that this material ~s not classified as a hazardous\nmaterial under 49CFR 171-180?\nThank you,\nDavid Schaper\nSr. Manager EHS\nSolst~ce Neurosciences\n701 Gateway Blvd., Suite 250\nS. San Francisco, CA 94080\n650-291-8206\ndavid.schaper@solsticeneuro.com\nName: David Schaper\nOrganization: Solstice Neurosciences\nEmail: david.schaper@solsticeneuro.com\nAddress: 701 Gateway Blvd. Suite 250\n: South San Francisco\nCode: 94080\nPhone: 650-291-8206\nFAX: 650-243-4478\n1","truncated":false,"body_characters":3960}