{"operation":"document","citation":"25-0044","title":"Centers for Disease Control and Prevention — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2025-08-07","effective_on":null,"summary":"25-0044 response to Centers for Disease Control and Prevention concerning 173.134.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-25-0044.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-25-0044.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-25-0044","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/2025-08/250044.pdf","body":"<<<PAGE 1>>>\n\n1200 New Jersey Avenue, SE\nWashington, DC 20590\nU.S. Department\nof Transportation\nPipeline and Hazardous\nMaterials Safety\nAdministration\nAugust 7, 2025\nKeri Kolb\nCenters for Disease Control and Prevention\n3156 Rampart Road\nMail Stop 2\nFort Collins, CO 80521\nReference No. 25-0044\nDear Ms. Kolb:\nThis letter is in response to your April 10, 2025 email requesting clarification of the Hazardous\nMaterials Regulations (HMR; 49 CFR Parts 171-180) applicable to materials classified and\ndescribed by the International Civil Air Organization (ICAO) as Division 6.2 infectious\nsubstances. Specifically, you request clarification on the proper classification (i.e., Category A or\nB) of chimeric viruses (non-culture). In your incoming email, you reference the indicative list\nprovided in the ICAO Technical Instructions for the Safe Transport of Dangerous Goods by Air\n(ICAO Technical Instructions) and the International Air Transportation Association Dangerous\nGoods Regulations.\nPHMSA notes that the Categories A and B described in the HMR at § 173.134 do not\nincorporate by reference nor are they intended to mirror the Categories A and B for Division 6.2\ninfectious substances listed in the ICAO Technical Instructions. For purposes of transporting\ninfectious substances within the United States, the indicative list of example Category A\ninfectious substances contained in the ICAO Technical Instructions should be considered solely\nas informational guidance to assist in appropriately classifying Category A and B infectious\nsubstances commensurate with the relevant HMR criteria. The ICAO list is not exhaustive and\nmay omit new or emerging pathogens and require amendments from time to time based on the\nlatest available data. Therefore, the indicative ICAO list is not included in the HMR as it is not\nintended to be regulatory in nature.\nFurthermore, for purposes of the HMR, it is the shipper’s responsibility to properly classify the\nmaterial in accordance with § 173.134 classification criteria for Division 6.2 infectious\nsubstances. Therefore, chimeric viruses, whether in a culture or non-cultured form, must be\nclassified in accordance with the criteria in § 173.134 and assigned the appropriate category for\ntransportation.\n\n<<<PAGE 2>>>\n\nI hope this information is helpful. Please contact us if we can be of further assistance.\nSincerely,\nDirk Der Kinderen\nChief, Standards and Development Branch\nStandards and Rulemaking Division\n\n<<<PAGE 3>>>\n\n25-0045\nHorne\nJones, Jessie Jane (PHMSA)\nFrom: INFOCNTR (PHMSA)\nSent: Thursday, April 10, 2025 1:08 PM\nTo: Hazmat Interps\nSubject: FW: CFR 49 IATA clarification about Chimeric viruses UN2814\nHello Hazmat Interps,\nPlease see the below request for leer of interpretaon.\nThe mailing address for the request is:\nKeri Kolb\nCenters for Disease Control and Prevention\n3156 Rampart Rd\nMail Stop 02\nFort Collins, CO 80521\nThanks,\nJonathon, HMIC\nFrom: Kolb, Keri (CDC/NCEZID/DVBD/ADB) <ryq1@cdc.gov>\nSent: Thursday, April 10, 2025 10:05 AM\nTo: INFOCNTR (PHMSA) <INFOCNTR.INFOCNTR@dot.gov>\nSubject: CFR 49 IATA clarification about Chimeric viruses UN2814\nYou don't often get email from ryq1@cdc.gov. Learn why this is important\nCAUTION: This email originated from outside of the Department of Transportation (DOT). Do not click on links\nor open attachments unless you recognize the sender and know the content is safe.\nHello,\nI was wondering if you would be able to assist me with clarification on chimeric viruses under the UN2814\nclassification.\nI have a question about a Category A shipment item.\nOn the list for Category A items in Table 3.6.D (2024 Iata & CDF 49 book) it indicates that viruses such as West Nile virus\n(cultures only), Eastern Encephalitis (cultures only) and Dengue virus (cultures only) are considered category A items.\nWe have several variants of these items that we ship and need clarification as to whether or not these items would be\nconsidered category A items in the eyes of the government. Some of these examples are the following. They are what is\nconsidered chimeric viruses.\n1\n\n<<<PAGE 4>>>\n\nChimeriVax West Nile virus\nEastern equine encephalitis/Sindbis Chimeric virus\nThese items are not cultures but \"chimeric\" viruses of items that are on the CAT A list. This is the definition of a chimeric\nvirus per the USDA:\nA chimera or chimeric virus is a virus that contains genetic material derived from two or more distinct viruses. It is defined\nby the Center for Veterinary Biologics (part of the U.S. Department of Agriculture's Animal and Plant Health Inspection\nService) as a \"new hybrid microorganism created by joining nucleic acid fragments from two or more different\nmicroorganisms in which each of at least two of the fragments contain essential genes necessary for replication.\"[1] The\nterm genetic chimera had already been defined to mean: an individual organism whose body contained cell populations\nfrom different zygotes or an organism that developed from portions of different embryos.[citation needed] Chimeric\nflaviviruses have been created in an attempt to make novel live attenuated vaccines.[2] ( i got this from Wikipedia)\nDo we ship these items as Cat A items, based on the name, or can we ship them as a CAT B because it's not a culture?\nI also need some kind of documentation that would support the finding so that we can have it on file or even better yet,\nsomeplace where I can go to get this clarified within the government. Can you please advise?\nThank you!\nKeri Kolb\nKeri Kolb\nAdministrative Support Specialist\nUS Department of Health and Human Services\nCenters for Disease Control and Prevention\nRyq1@cdc.gov\n970-225-4293\n2","truncated":false,"body_characters":5644}