{"operation":"document","citation":"09-0259","title":"Revance Therapeutics, Inc. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2009-12-11","effective_on":null,"summary":"09-0259 response to Revance Therapeutics, Inc. concerning 172.101, 173.196, 173.4.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-09-0259.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-09-0259.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-09-0259","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretations/2009/090259.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nof Transportation\nPipeline and Hazardous\nMaterials Safety\nAdministration\n1200 New Jersey Avenue, SE\nWashington, D.C. 20590\nDEC 11 2009\nMr. Philip Perotti\nQA Sr. Manager\nRevance Therapeutics, Inc.\n7555 Gateway Blvd\nNewark, CA 94560\nRef. No. 09-0259\nDear Mr. Perotti:\nThis responds to your letter requesting clarification of the packaging requirements for toxic\nsubstances under the Hazardous Materials Regulations (HMR; 49 CPR Parts 171-180).\nSpecifically, you ask whether any regulatory exceptions apply to shipments of Botulinum\nToxin A, a Division 6.1 Packing Group I hazardous material, in quantities of 0.5 mg per\nshipment. Your questions are paraphrased and answered as follows:\nQ1. Do the HMR provide any packaging exceptions for hazardous materials described as\n\"UN3462, Toxins, extracted from living sources, solid, n.o.s., 6.1, PG I'~?\nAI. No. Packaging exceptions for a hazardous material are specified, if any, in a section or\nsections identified in Column (8A) of the § 172.101 Hazardous Materials Table (HMT).\nThere is no section referenced in Column (8A) of the HMT entry for \"UN3462, Toxins,\nextracted from living sources, solid, n.o.s., 6.1, PG I.\"\nQ2. Special provision 141 is referenced in Column (7) of the HMT entry for UN3462. How\ndoes this special provision impact the proper description or packaging of Botulinum Toxin A?\nAZ. Under § 172.102(c)(1) Special provision 141, if your material also meets the criteria for a\nDivision 6.2 infectious substance, it must be described as UN2900 or UN2814, as appropriate,\nand packaged in accordance with requirements in § 173.196.\n\n<<<PAGE 2>>>\n\n03. If Botulinum Toxin A does not meet the definition of an infectious substance, is it\neligible for the small quantity exceptions under § 173.4?\nA3. Yes, if all the conditions specified in § 173.4 are met.\nI trust this satisfies your inquiry. Please contact us if we can be of further assistance.\nSi~ ~\nHattie L. Mitchell\nChief, Regulatory Review and Reinvention\nOffice of Hazardous Materials Standards\n\n<<<PAGE 3>>>\n\nS+evms\n~ It.3. I~3\nE-x. e.ep~ 0 nS\nl)'1-oz..5q\n7555 Gateway Blvd.\nNewark, CA 94560\np 510.742.3400 f510.742.3401\nwww.revance.com\nThursday, October 22, 2009\nU.S. Department of Transportation\nPHMSA Office of Hazardous Materials Standards\nATTN-PHH-1O\nEast Building\n1200 New Jersey Avenue, SE\nWashington, DC 20590-0001\nDear Sir or Madam,\nRevance intends to manufacture Botulinum Toxin A for commercial sale as a medicine in the future\nmuch like commercial Botox ® is today; I wish to understand how I can alleviate our current DOT\nshipping requirement for ID# UN3462; Hazard Class 6.1; Packaging Group I; Provision 141 - we\nwill be shipping commercial scale quantities of our product in the 2011 timeframe and wish to\nunderstand what our options are per DOT regulations. We do not intend to ship anymore at one time\nthan the 0.5mg quantities regulated by the CDC APHIS form 2 and the paint-can style packaging is\nnot feasible.\nI am referring to CFR 173.153(c)(2) but I do not understand the text in the General section\n173.153(a) that states the material is only eligible if it is referenced in the 172.101 Table ofthe\nsubchapter...... I cannot locate anything to this affect.\nCan you please help? What is the process of exemption for UN3462 per l73.153?\nThe DOT operators I get on the phone when I call a DOT helpline are not knowledgeable\nwhatsoever in this regard and do not know where to direct me. I get no response from any email\naddress I have attempted to contact from the website. I have spoken to Mr. William Clark, an FAA\nSecurity and Hazardous Materials Special Agent out of the Burlingame, California office on the\nphone and he has directed me to write this letter and follow-up by phone.\nI intend to attempt to contact someone at 1-800-467-4922 after sufficient time has been given to\nreceive and read this letter. If you wish, you can contact me directly by phone or by email.\nRegards,\nPhilip Perotti IQA Sr. Manager\nRevance Therapeutics, Inc.\n7555 Gateway Blvd I Newark, CA 94560\nT 510-742-34481 F 510-742-3401\npperotti@revance.com Iwww.revance.com","truncated":false,"body_characters":4116}