{"operation":"document","citation":"19-0032","title":"Locus Biosciences, Inc. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2019-05-23","effective_on":null,"summary":"19-0032 response to Locus Biosciences, Inc. concerning 173.134, 173.22.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-19-0032.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-19-0032.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-19-0032","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/docs/standards-rulemaking/hazmat/interpretations/71551/190032.pdf","body":"<<>>\n\nU.S. Department\nof Transportation\nPipeline and Hazardous\nMaterials Safety\nAdministration\n1200 New Jersey Avenue, SE\nWashington, DC 20590\nMAY? 3 2019\nNick Conley, PhD\nPrincipal Scientist\nLocus Biosciences, Inc.\n523 Davis Drive, Ste. 350\nMorrisville, NC 27560\nReference No. 19-0032\nDear Dr. Conley:\nThis letter is in response to your March 6, 2019, email requesting clarification of the Hazardous\nMaterials Regulations (HMR; 49 CFR Parts 171-180) applicable to classification of a specific\nstrain of E. coli bacteria. Specifically, you ask whether a culture of non-pathogenic E. coli that is\nbelieved to be not capable of causing disease in humans is subject to the HMR.\nThe HMR defines a Division 6.2 material in § 173 .134 as a material known to contain or\nsuspected of containing a pathogen. A pathogen is a microorganism (including bacteria, viruses,\nrickettsiae, parasites, fungi) or other agent, such as a proteinaceous infectious particle (prion) that\ncan cause disease in either humans or animals. In accordance with § 173.22, it is the shipper's\nresponsibility to properly class and describe a hazardous material. This Office does not perform\nthat function. If your material consists wholly of microorganisms that cannot cause disease in\neither humans or animals, and does not meet the definition of any other class of hazardous\nmaterial, then it is not subject to the HMR.\nI hope this information is helpful. Please contact us if we can be of further assistance.\nSincerely, ~\n40!/J/.\n'1 ///\n//2~;> 1,,1 .. f;<,~\nffur{ Der KinZ\nChief, Standards Development Branch\nStandards and Rulemaking Division\n\n<<>>\n\np~\n~ /73. { 0\nCc: Beverly Green \nSubject: request for written opinion: 49 CFR 173.134 Class 6, Division 6.2, Section b\nHi,\nMy name is Nick Conley, and I am a principal scientist at Locus Biosciences.\nI work with a Biosafety Level 1 (BSLl) £. coli bacteria strain, which is not believed to cause disease in healthy\nhumans. The product can be found here, and the SDS is attached . As an employee, I would like to transport\nthis material by private vehicle between two sites of my company that are located about 1.5 miles apart. The\naddresses are listed in my signature line below.\nI am writing to request a written opinion from US DOT confirming that this material is not subject to regulation\nas a Category A or Category B infectious substance due to the following two exemptions under 49 CFR 173.134\nClass 6, Division 6.2, Section b:\n(1) a material that does not contain an infectious substance or that is unlikely to cause disease in humans or\nanimals\n(3) a material containing micro-organisms that are non-pathogenic to humans or animals.\nCan you please provide a written opinion on this? You can reach me by e-mail or at 650-200-9569 if you have\nany questions.\nBest,\nNick\nNick Conley, PhD\nPrincipal Scientist\n1\n\n<<>>\n\nLocus Biosciences, Inc.\nGMP Mfg.: 7020 Kit Creek Rd., Ste. 270, Morrisville, NC 27560\nR&D: 523 Davis Dr., Ste. 350, Morrisville, NC 27560\n+1.650.200.9569 mobile I nick.conley@locus-bio.com\nThis email message is for the sole use of the intended recipient(s) and may contain confidential and privileged information. Any unaut11orized review, use ,\ndisclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply email and destroy all copies of the original message.\nIf you are the intended recipient. please be advised that the content of this message is subject to access, review and disclosure by the sender's Email System\nAdministrator.\n2\n\n<<>>\n\nATCC\nProduct Sheet\nEscherichia coli (A TCC®\n35382™)\nPlease read this FIRST\n~1\nIntended Use\nThis product is intended for research use only. It is not\nintended for any animal or human therapeutic or\ndiagnostic use.\nCitation of Strain\nIf use of this culture results in a scientific publication, it\nshould be cited in that manuscript in the following\nmanner: Escherichia coli (ATCC® 35382™)\nAmerican Type Culture Collection\nPO Box 1549\nManassas, VA 20 108 USA\nwww .atcc.org\n800.638.6597 or 703.365.2700\nFax: 703.365.2750\nEmail : Tech@atcc.org\nOr contact your local distributor\nPage 1 of 1\nCi) Description\nDesignation: ECOR 63\nDeposited Name: Escherichia coli (Migula) Castellani and Chalmers\n•• 'ii' Propagation\nMedium\nATCC® Medium 3: Nutrient agar or nutrient broth\nGrowth Conditions\nTemperature: 37.0\"C\nII References\nReferences and other information relating to this product are available online at www.atcc.org.\n~ Biosafety Level: 1\nAppropriate safety procedures should always be used with this material. Laboratory safety is discussed in\nthe current publication of the Biosafety. in Microbiological and Biomedical Laboratories from the U.S.\nDepartment of Health and Human Services Centers for Disease Control and Prevention and National Institutes\nfor Health.\nATCC Warranty\nATCC® products are warranted for 30 days from the date of shipment, and this warranty is valid only if the\nproduct is stored and handled according to the information included on this product information sheet. If the\nATCC® product is a living cell or microorganism, ATCC lists the media formulation that has been found to be\neffective for this product. While other, unspecified media may also produce satisfactory results, a change in\nmedia or the absence of an additive from the ATCC recommended media may affect recovery, growth and/or\nfunction of this product. If an alternative medium formulation is used, the A TCC warranty for viability is no\nlonger valid.\nDisclaimers\nThis product is intended for laboratory research purposes only. It is not intended for use in humans.\nWhile ATCC uses reasonable efforts to include accurate and up-to-dale information on this product sheet,\nATCC makes no warranties or representations as to its accuracy. Citations from scientific literature and\npatents are provided for informational purposes only. ATCC does not warrant that such information has been\nconfirmed to be accurate.\nThis product is sent with the condition that you are responsible for its safe storage, handling, and use. ATCC\nis not liable for any damages or injuries arising from receipt and/or use of this product. While reasonable effort\nis made to insure authenticity and reliability of materials on deposit, ATCC is not liable for damages arising from\nthe misidentification or misrepresentation of such materials.\nPlease see the enclosed Material Transfer Agreement (MTA) for further details regarding the use of this\nproduct. The MTA is also available on our Web site at www.atcc.org\nAdditional information on this culture is available on tile ATCC web site at www.atcc.org.\n@ A TCC 2018. All rights reserved. ATCC is a registered trademark of the American Type Culture Collection. /081 08)","truncated":false,"body_characters":7284}