{"operation":"document","citation":"14-0140","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":"2014-10-15","effective_on":null,"summary":"14-0140 response to Centers for Disease Control and Prevention concerning 171.8, 172.203.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-14-0140.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-14-0140.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-14-0140","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2014/140140.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nof Transportation\n1200 New Jersey Avenue, SE\nWashington, D.C. 20590\nMaterials Safety\nPipeline and Hazardous\nAdministration\nOCT 1 5 2014\nPaul J. Meechan, Ph.D., MPH\nDirector, Environment, Health\nand Safety Compliance Office\nCenters for Disease Control and Prevention\nBuilding 20, Room 2211, M/S F-05\n1600 Clifton Road\nAtlanta, GA 30329\nReference No. 14-0140\nDear Dr. Meechan:\nThis is in response to your April 25, 2014 letter requesting clarification of the U.S.\nDepartment of Transportation (DOT) regulations applicable to transporting select agents\nunder the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). Specifically,\nyou ask if \"Suspected Category A Infectious Substance\" may be used as the proper shipping\nname to describe all Division 6.2 (infectious) select agents under the HMR. Ms. Lori Bane,\nAssociate Director for Policy, Centers for Disease Control and Prevention (CDC),\nDepartment of Health and Human Services, forwarded your letter to us on July 16, 2014.\nWe have no past record of receiving your letter. We apologize for the delay in responding\nand any inconvenience this may have caused.\nYou state your agency and the U.S. Department of Agriculture's (USDA's) Animal and Plant\nHealth Inspection Service (APHIS) have issued guidance in the past in support of using\n\"Suspected Category A Infectious Substance\" as the technical name as part of the proper\nshipping description for an infectious substance, even when the name of the agent is known,\nto encourage the safe transport of these materials through a \"lost in the crowd\" concept.\nHowever, you state since 2009 DOT and other inspectors have increasingly cited packages\ndescribed in this manner as failing to use an authorized technical name under the HMR. You\nrecommend using this technical name as the proper shipping name to reduce the chance of\nthese packages becoming frustrated in transit while still supporting the \"lost in the crowd\"\nconcept.\nUnder § 172.203(k), a Division 6.2 material assigned identification number UN 2814 or\nUN 2900 that is suspected to contain an unknown Category A infectious substance must have\nthe words \"suspected Category A infectious substance\" entered in parentheses in place of the\n\"technical name\" as part of the proper shipping description. When the identity of the\npathogen contained in an infectious substance is known, the technical name (see § 171.8),\nwhich can be a recognized chemical name or microbiological name or generic group, or for\nproficiency testing a generic microbiological description, of the pathogen must be indicated\nin parentheses in association with the basic description on a shipping paper as prescribed in\n§ 172.203 (k).\n\n<<<PAGE 2>>>\n\nIf you wish to transport the select agent materials in the manner you described, you have the\nfollowing options. A \"person,\" as this term is defined in § 171.8, may petition PHMSA to\nadd or amend the HMR to include this wording as a proper shipping name through a\nrulemaking action in conformance with the procedures prescribed in 49 CFR 106.95 through\n106.130. Proper shipping names are part of a uniform system of internationally accepted\nwords and images designed to provide transportation workers and emergency responders\nwith sufficient information to properly prepare the material for transport and to respond\nappropriately to contain risks that may be present if the material is released.\nPHMSA designs and revises hazardous material proper shipping names, coded numbers, and\nimages as needed in consultation with the specialized agencies of United Nations (UN)\nCDC and APHIS. We believe this system of hazard communication supports the\nEconomic and Social Council and other federal and international agencies, including the\nCDC/APHIS \"lost in the crowd\" concept in that it is also designed to attract minimal\nattention from the general public. However, if additional changes are needed to ensure the\nsafe transportation of select agent materials, we welcome discussing this matter with you.\nSincerely,\nThen resta\nT. Glenn Foster\nChief, Regulatory Review and Reinvention Branch\nStandards and Rulemaking Division\n2\n\n<<<PAGE 3>>>\n\nFrame shipping 204)\nDEPARTMENT OF HEALTH AND HUMAN SERVICES\nPublic Health Service\n14-0140\nCenters for Disease Control\nand Prevention (CDC)\nAtlanta GA 30333\nU.S. Department of Transportation\nCenters for Disease Control\nPHMSA Office of Hazardous Materials Standards\nand Prevention\nAttn: PHH-10\n1600 Clifton Road\nEast Building\nBldg 20, Room 2211\n1200 New Jersey Avenue, SE.\nM/S F-05\nWashington, DC 20590-0001\nAtlanta, GA 30329\n25 April 2014\nSubject: Request for Interpretation of 49 CFR 172.101 and 172.202 and Technical name\nrequirements for Select Agents (42 CFR part 73, 9 CFR part 121, and 7 CFR part 331).\nDear Sir or Madam:\nI am writing to request an interpretation from the Department of Transportation (DOT)\nHazardous Materials regulations (49 C.F.R. Parts 171-180) concerning the completion of the\nShipper's Declaration for Dangerous Goods (Declaration) for shipments of biological agents and\ntoxins listed in 42 C.F.R. §§ 73.3,4 and 9 C.F.R. §8 121.3, 4. (select agents and toxins).\nAs we read them, the DOT Hazardous Materials regulations currently require entities that ship\ninfectious materials, such select agents and toxins, enter \"INFECTIOUS SUBSTANCE,\nAFFECTING HUMANS\" or \"INFECTIOUS SUBSTANCE, AFFECTING ANIMALS ONLY\"\nin the Declaration's \"Proper Shipping Name\" block followed by the specific technical name such\nas \"Ebola virus\" or \"Foot and Mouth disease virus.\"\nHowever, we have received guidance from the Centers for Disease Control and Prevention's\nDivision of Select Agent and Toxins (DSAT) and the Animal and Plant Health Inspection\nService's Agriculture Select Agent Services (AgSAS) that, for security purposes, entities\nshipping select agents and toxins should use a \"lost in the crowd\" concept. Specifically, DSAT\nguidance is that in filling out the Declaration, an entity should enter \"INFECTIOUS\nSUBSTANCE, AFFECTING HUMANS\" followed by \"SUSPECTED CATEGORY A\nINFECTIOUS SUBSTANCE\" in the \"Proper Shipping Name\" block even when the entity\nknows the technical name of the infectious substance, such as \"Ebola virus.\" AgSAS guidance is\nthat in filling out the Declaration, an entity should enter \"INFECTIOUS SUBSTANCE,\nAFFECTING ANIMALS ONLY\" and \"SUSPECTED CATEGORY A INFECTIOUS\nSUBSTANCE\" in the \"Proper Shipping Name\" block even when the entity knows the technical\nname of the infectious substance, such as \"Foot and Mouth disease virus.\" The DSAT and\n\n<<<PAGE 4>>>\n\nAgSAS guidance states that the \"DOT recommends the use of 'lost in the crowd' for all\nshipments of a select agent and toxin.'\"\nWe were implementing the \"lost in the crowd\" concept until we were cited by DOT inspectors in\n2009 for tailing to use an agent's technical name in filling out the Declaration. 1 am requesting a\nDOT interpretation whether the term \"Suspected Category A Infectious Substance\" can be used\nas the proper shipping name for all Select Agents.\nThank you for your assistance in this matter. If you have additional questions, please contact me\neither via email at pmeechan@cdc.gov or at 404-639-3147.\nSincerely,\nPaul J. Meechan, Ph.D., MPH\nDirector, Environment, Health and Safety Compliance Office\nCenters for Disease Control and Prevention\n\n<<<PAGE 5>>>\n\nEdmenson\n173.134\nDefinitions\nDodd, Alice (PHMSA)\n14-0140\nFrom:\nSent:\nEdmonson, Eileen (PHMSA)\nThursday, July 17, 2014 10:26 AM\nTo:\nDodd, Alice (PHMSA); Goodall, Shante CTR (PHMSA)\nSubject:\nAttachments:\nFW: Interpretation for CDC\nDOT LETTER.DOCX\nAlice and Shante,\nPlease log the attached letter into Filemaker and assign it to me. I just received it yesterday.\nThanks,\nEileen Edmonson\nUSDOT/PHMSA\n(202) 366-7041 (f)\n(202) 366-4481 (W)\neileen.edmonson@dot.gov (e-mail)\nhttp://www.phmsa.dot.gov/hazmat (website)\ninfocntr@dot.gov (Hazmat Info Center E-mail)\nFrom: Bane, Lori (CDC/OPHPR/DSAT) [mailto:zoz1@cdc.gov]\nSent: Wednesday, July 16, 2014 4:58 PM\nTo: Edmonson, Eileen (PHMSA)\nCc: Stevens, William (PHMSA); Foster, Glenn (PHMSA)\nSubject: RE: Interpretation for CDC\nEileen,\nI apologize for not being cleared. Please find attached the letter from the registered entity, CDC.\nThanks,\nLori J. Bane\nAssociate Director for Policy\n1600 Clifton Road MS A-46\nCDC.Division of Select Agents and Toxins\nAtlanta, GA 30333\n404-718-2006\nFax: 404-718-2096\nzozl@cdc.gov\nhttp://www.selectagents.gov/\nDSAT Vision: To be the preeminent resource for the safety and security of biological agents and toxins.\nThis document is intended for the exclusive use of the recipients) named above. It may contain sensitive information that\nis protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized\nto receive such information. If you are not the intended recipients), any dissemination, distribution, or copying is strictly\nprohibited. If you think you have received this document in error, please notify the sender immediately and destroy the\noriginal. Thank you.\n1\n\n<<<PAGE 6>>>\n\nFrom: eileen.edmonson@dot.gov [mailto: eileen.edmonson@dot.gov]\nSent: Wednesday, July 16, 2014 3:32 PM\nTo: Bane, Lori (CDC/OPHPR/DSAT)\nSubject: RE: Interpretation for CDC\nCc: William. Stevens@dot.gov; Glenn.Foster@dot.gov\nHello Lori,\nAre you referring to the document I provided edits to you on July 35d (see e-mails below and the attachment)?\nI searched my office's catalogue of the requests its received for letters of clarification on my agency's regulations and\ncannot find a recent one from the CDC. If the attached e-mail is not what you seek, can you tell me the topic of the\nrequest and who it came from?\nSincerely,\nUSDOT/PHMSA\nEileen Edmonson\n(202) 366-4481 (W)\neileen.edmonson@dot.gov (e-mail)\n(202) 366-7041 (f)\ninfocntr@dot.gov (Hazmat Info Center E-mail)\nhttp://www.phmsa.dot.gov/hazmat (website)\nFrom: Bane, Lori (CDC/OPHPR/DSAT) [mailto:zoz1@cdc.gov]\nSent: Wednesday, July 16, 2014 12:35 PM\nTo: Edmonson, Eileen (PHMSA)\nSubject: Interpretation for CDC\nCc: Stevens, William (PHMSA)\nEileen,\nCan I get the status on the letter for interpretation for CDC?\nThanks,\nLori J. Bane\nAssociate Director for Policy\nCDC Division of Select Agents and Toxins\n1600 Clifton Road MS A-46\n404-718-2006\nAtlanta, GA 30333\nFax: 404-718-2096\nzoz1@cdc.gov\nhttp://www.selectagents.gov/\nDSAT Vision: To be the preeminent resource for the safety and security of biological agents and toxins.\nThis document is intended for the exclusive use of the recipients) named above. It may contain sensitive information that\nis protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized\nto receive such information. If you are not the intended recipient(s), any dissemination, distribution, or copying is strictly\nprohibited. If you think you have received this document in error, please notify the sender immediately and destroy the\noriginal. Thank you.\n2","truncated":false,"body_characters":10939}