Centers for Disease Control and Prevention (CDC) — Hazardous Materials Safety Interpretation

Page 1U.S. Department of Transportation Pipeline and Hazardous Materials Safety Administration 1200 New Jersey Avenue, SE Washington, DC 20590 January 29, 2021 Ms. Lori J. Bane Associate Director for Policy Centers for Disease Control and Prevention (CDC) Division of Select Agents and Toxins 1600 Clifton Road MS H21-7 Atlanta, GA 30329 Reference No. 20-0035 This letter is in response to your April 24, 2020, email, and November 4, 2020, telephone call with several members of the Office of Hazardous Materials Safety, Pipeline and Hazardous Materials Safety Administration (PHMSA) requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to the marking requirements for non-bulk packagings. Specifically, you ask whether a “technical name” and/or “specific name” is required to be marked on a non-bulk package containing a material assigned one of the following proper shipping names: “UN2814, Infectious substances, affecting humans, 6.2;” “UN2900, Infectious substances, affecting animals only, 6.2;” “UN3462, Toxins, extracted from living sources, solid, n.o.s., 6.1, PG I/II/II;” or“UN3172, Toxins, extracted from living sources, liquid, n.o.s., 6.1, PG I/II/III.” For a package containing a Division 6.1 material such as UN3462 or UN3172, the answer is yes. The technical name is required to be marked on the outside of a non-bulk packaging in accordance with § 172.301(b). The HMR require a technical name, as defined in § 171.8, to be used on the shipping paper (see § 172.203(k)) and outer packaging for a material with the letter “G” assigned to column (1) of the Hazardous Materials Table (HMT; § 172.101). The HMR define a “technical name” as a recognized chemical or microbiological name currently used in scientific and technical handbooks, journals, and texts. Generic descriptions are authorized for use provided they readily identify the general chemical group or microbiological group. Conversely, for a package containing a Division 6.2 material such as UN2814 or UN2900, the answer is no. The technical name should not be included on the outside of a non-bulk package in accordance with § 172.301(b). However, it should be noted that a Division 6.2 infectious substance with a “G” in column (1) of the HMT must have a technical name included in parentheses in association with the basic description on the shipping paper (see § 172.203(k)).#

Page 2If the Division 6.2 material is assigned identification number UN2814 or UN2900 and is suspected to contain an unknown Category A infectious substance, the words “suspected Category A infectious substance” must be entered in parentheses in place of the technical name as part of the proper shipping description (§ 172.203(k)). I hope this information is helpful. Please contact us if we can be of further assistance. Sincerely, T. Glenn Foster Chief, Regulatory Review and Reinvention Branch Standards and Rulemaking Division#

Page 3Edmonson 20-0035 From: Subject: To: Edmonson, Eileen (PHMSA) Dodd, Alice (PHMSA); January, Ikeya CTR (PHMSA) Date: FW: Letter request Friday, April 24, 2020 3:35:37 PM Hi Ladies, I don't know which one of you logs in letters for processing so I'm sending this to you both. You can assign it to me. Thanks, Eileen *****Start the Letter Below Here ***** From: Bane, Lori (CDC/DDPHSIS/CPR/DSAT) <zoz1@cdc.gov> Sent: Friday, April 24, 2020 3:06 PM To: Edmonson, Eileen (PHMSA) <eileen.edmonson@dot.gov> Subject: RE: Letter request Eileen, What was provided doesn't really help, I guess we will need a letter that states for select agents and oxins, technical/specific names should not be listed on package. For select agents and toxins roper shipping description is "UN 2814, Infectious substances, affecting humans, 6.2" or "Ul 2900, Infectious substances, affecting animals." Select toxins proper shipping description is "UN 3462 - Toxins extracted from living sources, solid" or "UN 3172 - Toxins extracted from living sources, liquid." Thanks, Lori J. Bane Associate Director for Policy CDC Division of Select Agents and Toxins 1600 Clifton Road MS H21-7 Atlanta, GA 30329 404-718-2006 Fax: 404-718-2096 zoz1@cdc.gov http://www.selectagents.gov/ From: Edmonson, Eileen (PHMSA) <eileen.edmonson@dot.gov> Sent: Friday, April 24, 2020 11:04 AM To: Bane, Lori (CDC/DDPHSIS/CPR/DSAT) <zoz1@cdc.gov> Subject: RE: Letter request Hi Lori,#

Page 4I apologize for the delay in responding with this information. A few projects came up that required my immediate attention. We have two requirements that affect the choice of technical name in a proper shipping description- -the definition of “technical name” in 49 CFR 171.8, and the instructions on how to select a technical name and insert it on a shipping paper in § 172.101(k). For convenience, I’ve included both below. § 171.8 Technical name means a recognized chemical name or microbiological name currently used in scientific and technical handbooks, journals, and texts. Generic descriptions are authorized for use as technical names provided they readily identify the general chemical group, or microbiological group. Examples of acceptable generic chemical descriptions are organic phosphate compounds, petroleum aliphatic hydrocarbons and tertiary amines. For proficiency testing only, generic microbiological descriptions such as bacteria, mycobacteria, fungus, and viral samples may be used. Except for names which appear in subpart B of part 172 of this subchapter, trade names may not be used as technical names. § 172.203(k) (k) Technical names for “n.o.s.” and other generic descriptions. Unless otherwise excepted, if a material is described on a shipping paper by one of the proper shipping names identified by the letter “G” in column (1) of the §172.101 Table, the technical name of the hazardous material must be entered in parentheses in association with the basic description. For example “UN 1760, Corrosive liquid, n.o.s., (Octanoyl chloride), 8, II”, or “UN 1760, Corrosive liquid, n.o.s., 8, II (contains Octanoyl chloride)”. The word “contains” may be used in association with the technical name, if appropriate. For organic peroxides which may qualify for more than one generic listing depending on concentration, the technical name must include the actual concentration being shipped or the concentration range for the appropriate generic listing. For example, “UN 3102, Organic peroxide type B, solid, 5.2, (dibenzoyl peroxide, 52-100%)” or “UN 3108, Organic peroxide type E, solid, 5.2, (dibenzoyl peroxide, paste, <52%)”. Shipping descriptions for toxic materials that meet the criteria of Division 6.1, PG I or II (as specified in §173.132(a) of this subchapter) or Division 2.3 (as specified in §173.115(c) of this subchapter) and are identified by the letter “G” in column (1) of the §172.101 Table, must have the technical name of the toxic constituent entered in parentheses in association with the basic description. A material classed as Division 6.2 and assigned identification number UN 2814 or UN 2900 that is suspected to contain an unknown Category A infectious substance must have the words “suspected Category A infectious substance” entered in parentheses in place of the technical name as part of the proper shipping description. For additional technical name options, see the definition for “Technical name” in §171.8. A technical name should not be marked on the outer package of a Division 6.2 material (see §172.301(b)). (1) If a hazardous material is a mixture or solution of two or more hazardous materials, the technical names of at least two components most predominately contributing to the hazards of the mixture or solution must be entered on the shipping paper as required by paragraph (k) of this section. For example, “UN 2924, Flammable liquid, corrosive, n.o.s., 3 (8), II#

Page 5(contains Methanol, Potassium hydroxide)”. (2) The provisions of this paragraph do not apply— (i) To a material that is a hazardous waste and described using the proper shipping name “Hazardous waste, liquid or solid, n.o.s.”, classed as a miscellaneous Class 9, provided the EPA hazardous waste number is included on the shipping paper in association with the basic description, or provided the material is described in accordance with the provisions of §172.203(c) of this part. (ii) To a material for which the hazard class is to be determined by testing under the criteria in §172.101(c)(11). (iii) If the n.o.s. description for the material (other than a mixture of hazardous materials of different classes meeting the definitions of more than one hazard class) contains the name of the chemical element or group which is primarily responsible for the material being included in the hazard class indicated. (iv) If the n.o.s. description for the material (which is a mixture of hazardous materials of different classes meeting the definition of more than one hazard class) contains the name of the chemical element or group responsible for the material meeting the definition of one of these classes. In such cases, only the technical name of the component that is not appropriately identified in the n.o.s. description shall be entered in parentheses. Here are the website links to the most recent letters my agency issued where I found explanations of the technical name and how it used for a Category A infectious substance. Each web page includes a link to the PDF for the letter. Reference No. 14-0140 https://www.phmsa.dot.gov/regulations/title49/interp/14-0140 Reference No. 11-0258 https://www.phmsa.dot.gov/regulations/title49/interp/11-0258 I hope this satisfies your request. Please let me know if you need additional information. Sincerely, Eileen Edmonon USDOT/PHMSA From: Bane, Lori (CDC/DDPHSIS/CPR/DSAT) <zoz1@cdc.gov> Sent: Tuesday, April 21, 2020 6:13 PM To: Edmonson, Eileen (PHMSA) <eileen.edmonson@dot.gov>#

Page 6Subject: RE: Letter request Whichever is easiest would be great. I’ll see if that will work. Thanks, Lori J. Bane Associate Director for Policy CDC Division of Select Agents and Toxins 1600 Clifton Road MS H21-7 Atlanta, GA 30329 404-718-2006 Fax: 404-718-2096 zoz1@cdc.gov http://www.selectagents.gov/ From: Edmonson, Eileen (PHMSA) <eileen.edmonson@dot.gov> Sent: Tuesday, April 21, 2020 3:57 PM To: Bane, Lori (CDC/DDPHSIS/CPR/DSAT) <zoz1@cdc.gov> Subject: RE: Letter request Hi Lori, The fastest way to get this information is from something we’ve already published or released. I think we’ve done clarification letters on this in the past. It may even be in a rulemaking preamble. I have to do some research. Can I give you the results of my research tomorrow? Or are you asking for a letter formally prepared and signed by the agency to you on this subject? This response will take several weeks or months to get reviewed and signed. Eileen USDOT/PHMSA From: Bane, Lori (CDC/DDPHSIS/CPR/DSAT) <zoz1@cdc.gov> Sent: Tuesday, April 21, 2020 1:33 PM To: Edmonson, Eileen (PHMSA) <eileen.edmonson@dot.gov> Subject: Letter request Eileen, Is it possible to get a letter from DOT to clarify to our regulated community that instead of listing the specific name for select agents and toxins should be classified as a Category A infectious substance. Select agents proper shipping description is “UN 2814, Infectious substances, affecting humans, 6.2” or “UN 2900, Infectious substances, affecting animals.” Select toxins proper shipping description is “UN 3462 - Toxins extracted from living sources, solid” or “UN 3172 - Toxins extracted from living sources, liquid.”#

Page 7Thanks, Lori J. Bane Associate Director for Policy CDC Division of Select Agents and Toxins 1600 Clifton Road MS H21-7 Atlanta, GA 30329 404-718-2006 Fax: 404-718-2096 zoz1@cdc.gov http://www.selectagents.gov/#