Locus Biosciences, Inc. — Hazardous Materials Safety Interpretation

Page 1U.S. Department of Transportation Pipeline and Hazardous Materials Safety Administration 1200 New Jersey Avenue, SE Washington, DC 20590 MAY? 3 2019 Nick Conley, PhD Principal Scientist Locus Biosciences, Inc. 523 Davis Drive, Ste. 350 Morrisville, NC 27560 Reference No. 19-0032 Dear Dr. Conley: This letter is in response to your March 6, 2019, email requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to classification of a specific strain of E. coli bacteria. Specifically, you ask whether a culture of non-pathogenic E. coli that is believed to be not capable of causing disease in humans is subject to the HMR. The HMR defines a Division 6.2 material in § 173 .134 as a material known to contain or suspected of containing a pathogen. A pathogen is a microorganism (including bacteria, viruses, rickettsiae, parasites, fungi) or other agent, such as a proteinaceous infectious particle (prion) that can cause disease in either humans or animals. In accordance with § 173.22, it is the shipper's responsibility to properly class and describe a hazardous material. This Office does not perform that function. If your material consists wholly of microorganisms that cannot cause disease in either humans or animals, and does not meet the definition of any other class of hazardous material, then it is not subject to the HMR. I hope this information is helpful. Please contact us if we can be of further assistance. Sincerely, ~ 40!/J/. '1 /// //2~;> 1,,1 .. f;<,~ ffur{ Der KinZ Chief, Standards Development Branch Standards and Rulemaking Division#

Page 2p~ ~ /73. { 0<f (9-003s9 Dodd, Alice (PHMSA) From: Sent: To: Subject: Attachments: INFOCNTR (PHMSA) Monday, March 18, 2019 12:18 PM Hazmat Interps 35382.pdf FW: request for written opinion: 49 CFR 173.134 Class 6, Division 6.2, Section b Hello Alice and lkeya, Below is a request for letter of interpretation. Breanna provided 09-0065. Caller still wants a letter. Thanks, Jonathon From: Nick Conley [mailto:nick.conley@locus-bio.com] Sent: Wednesday, March 06, 2019 2:21 PM To: INFOCNTR (PHMSA) <INFOCNTR.INFOCNTR@dot.gov> Cc: Beverly Green <beverly.green@locus-bio.com> Subject: request for written opinion: 49 CFR 173.134 Class 6, Division 6.2, Section b Hi, My name is Nick Conley, and I am a principal scientist at Locus Biosciences. I work with a Biosafety Level 1 (BSLl) £. coli bacteria strain, which is not believed to cause disease in healthy humans. The product can be found here, and the SDS is attached . As an employee, I would like to transport this material by private vehicle between two sites of my company that are located about 1.5 miles apart. The addresses are listed in my signature line below. I am writing to request a written opinion from US DOT confirming that this material is not subject to regulation as a Category A or Category B infectious substance due to the following two exemptions under 49 CFR 173.134 Class 6, Division 6.2, Section b: (1) a material that does not contain an infectious substance or that is unlikely to cause disease in humans or animals (3) a material containing micro-organisms that are non-pathogenic to humans or animals. Can you please provide a written opinion on this? You can reach me by e-mail or at 650-200-9569 if you have any questions. Best, Nick Nick Conley, PhD Principal Scientist 1#

Page 3Locus Biosciences, Inc. GMP Mfg.: 7020 Kit Creek Rd., Ste. 270, Morrisville, NC 27560 R&D: 523 Davis Dr., Ste. 350, Morrisville, NC 27560 +1.650.200.9569 mobile I nick.conley@locus-bio.com This email message is for the sole use of the intended recipient(s) and may contain confidential and privileged information. Any unaut11orized review, use , disclosure 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. If 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 Administrator. 2#

Page 4ATCC Product Sheet Escherichia coli (A TCC® 35382™) Please read this FIRST ~1 Intended Use This product is intended for research use only. It is not intended for any animal or human therapeutic or diagnostic use. Citation of Strain If use of this culture results in a scientific publication, it should be cited in that manuscript in the following manner: Escherichia coli (ATCC® 35382™) American Type Culture Collection PO Box 1549 Manassas, VA 20 108 USA www .atcc.org 800.638.6597 or 703.365.2700 Fax: 703.365.2750 Email : Tech@atcc.org Or contact your local distributor Page 1 of 1 Ci) Description Designation: ECOR 63 Deposited Name: Escherichia coli (Migula) Castellani and Chalmers •• 'ii' Propagation Medium ATCC® Medium 3: Nutrient agar or nutrient broth Growth Conditions Temperature: 37.0"C II References References and other information relating to this product are available online at www.atcc.org. ~ Biosafety Level: 1 Appropriate safety procedures should always be used with this material. Laboratory safety is discussed in the current publication of the Biosafety. in Microbiological and Biomedical Laboratories from the U.S. Department of Health and Human Services Centers for Disease Control and Prevention and National Institutes for Health. ATCC Warranty ATCC® products are warranted for 30 days from the date of shipment, and this warranty is valid only if the product is stored and handled according to the information included on this product information sheet. If the ATCC® product is a living cell or microorganism, ATCC lists the media formulation that has been found to be effective for this product. While other, unspecified media may also produce satisfactory results, a change in media or the absence of an additive from the ATCC recommended media may affect recovery, growth and/or function of this product. If an alternative medium formulation is used, the A TCC warranty for viability is no longer valid. Disclaimers This product is intended for laboratory research purposes only. It is not intended for use in humans. While ATCC uses reasonable efforts to include accurate and up-to-dale information on this product sheet, ATCC makes no warranties or representations as to its accuracy. Citations from scientific literature and patents are provided for informational purposes only. ATCC does not warrant that such information has been confirmed to be accurate. This product is sent with the condition that you are responsible for its safe storage, handling, and use. ATCC is not liable for any damages or injuries arising from receipt and/or use of this product. While reasonable effort is made to insure authenticity and reliability of materials on deposit, ATCC is not liable for damages arising from the misidentification or misrepresentation of such materials. Please see the enclosed Material Transfer Agreement (MTA) for further details regarding the use of this product. The MTA is also available on our Web site at www.atcc.org Additional information on this culture is available on tile ATCC web site at www.atcc.org. @ A TCC 2018. All rights reserved. ATCC is a registered trademark of the American Type Culture Collection. /081 08)#