Warrenton Regional Laboratory, Virginia Department of Agriculture and Consumer Services — Hazardous Materials Safety Interpretation

Page 1Washington, D.C. 20590 400 Seventh St., S.W. Research and pecial Program dministratior MAY 8 2002 Ref. No. 02-0127 Beth E. Henricson, Ph.D. Microbiologist Supervisor Warrenton Regional Laboratory, Virginia Department of Agriculture and Consumer Services 272 Academy Hill Road Warrenton, Virginia 20186 Dear Dr. Henricson: This responds to your May 1, 2002 e-mailed request for clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) as they apply to shipments of infectious substances. Specifically, you ask whether a shipper may use a generic description as a technical name for an infectious substance in place of the specific name of the pathogen contained in the infectious substance. As defined in § 171.8 of the HMR, "technical name" means a recognized chemical name or microbiological name currently used in scientific and technical handbooks, journals, and texts. A generic description is authorized for use as a technical name provided it readily identifies the general chemical group or microbiological group. For example, an infectious substance that contains the pathogen bacillus anthracis could be described on a shipping paper as "Infectious substance, affecting humans (bacillus species), 6.2, UN 2814" since "bacillus" is the genus or group name for the micro- organism. In accordance with § 171.8, generic microbiological descriptions such as "bacteria," "fungus," or "viral samples" may be used only for samples of infectious substances that are being transported for laboratory proficiency testing. Note that the emergency response information that must accompany a shipment of an infectious substance, in accordance with Subpart G of Part 172 of the HMR, must be specific to the pathogen contained in the infectious substance. In the case of a shipment of bacillus anthracis, the emergency response information must include specific information about the health and safely risks, how to handle a spill, and preliminary first aid measures (sec § 172.602(a)). I hope this information is helpful. If you have further questions, please do not hesitate to contact this office. Sincerely, elena 4. Mazzile Edward T. Mazzullo, Direct Office of Hazardous Materials Standards 111.8 020127#

Page 2cc: Mr. Mike Hoysler Dangerous Goods Administration and Safety FED EX Express 3670 Hacks Cross Road Building G 2nd Floor Memphis, Tenn 38125#

Page 3Gorsky 8|71. 8 Definitions 1 May 2002 02-0127 DAvard Mazarious Materials Standards 400 7th Street SW DHM 10 ATTN: Ms. Susan Gorsky Washington, DC 20590 Dear Sir: Laboratory Safety Committee hosted a teleconference with officials from DOT, USDA, AAVLD committee On 29 March of this year, the Association of Veterinary Laboratory Diagnosticians (AAVLD) members, and Fed Ex. AAVLD's members are primarily scientific directors and scientific supervisors of biosecurity of 6.2 labeled packages that contain infectious agents of potential use in incidents of bio- or state and federal regulatory and university veterinary diagnostic laboratories. Because of concern over alter the labeling so the packages would not be targeted for theft of the organisms contained in them. DOT agro-terrorism, government agencies receiving those packages from our regulatory laboratories wished to of your office, determined that our request did not require an exception to existing regulations. Regulations officials from the Research and Special Programs Division, Ms. Susan Hedgepeth, and Ms. Susan Gorsky Affecting Humans and Animals-Bacterial Pathogen," rather than specifying that the package contained were interpreted to allow a generic statement of pathogens contained, such as "Infectious Substance "Bacillus anthracis", for example. requested that they receive a written interpretation of the existing regulations from DOT to that effect, I spoke with Mr. Mike Hoysler of Fed Ex again this weck, and the Fed Ex legal department has allowing them to accept use of a generic statement in place of the technical name pathogen description. At interpretation of the regulations to that effect to the appropriate Fed Ex personnel. Copies of the the suggestion of Ms. Gorsky, I am writing this letter to ask if your office will provide a written distributed to all AAVLD-associated laboratories. Thank you for your prompt attention to this matter. interpretation of DOT regulations permitting generic labeling of 6.2 packages in these instances will be Sincerely, Microbiologist Supervisor Warrenton Regional Animal Health Laboratory Quality Assurance Coordinator Virgin of Deparment SAgriculture and Consumer Services FAX: 1-540-347-6404 Phone: 1-540-347-6385 --.#