{"operation":"document","citation":"10-0188","title":"American Veterinary Medical Association — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2011-01-30","effective_on":null,"summary":"10-0188 response to American Veterinary Medical Association concerning 171.1, 172.704, 173.134, 173.199.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-10-0188.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-10-0188.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-10-0188","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretations/2010/100188.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department of Transportation 1200 New Jersey Ave, SE\nWashington. D.C. 20590\nPipeline and Hazardous Materials\nSafety Administration\nKristi Henderson, DVM\nAssistant Director, Scientific Activities\nAmerican Veterinary Medical Association\n1931 North Meacham Road, Suite 100\nSchamburg, IL 60173\nReference No. 10-0188\nDear Dr. Henderson:\nThis is in response to your e-mail requesting clarification ofthe Hazardous Materials Regulations\n(HMR; 49 CFR Parts 171-180) applicable to training requirements. Specifically, you request\nguidance on what type of hazardous materials (hazmat) training and documentation is required to\nship veterinary medical samples. You also ask if the statements posted on your website pertaining\nto this subject are correct, or need to be revised or supplemented. We have paraphrased your\nstatements and responded in the order you provided.\nQ I: Is specific formal hazmat training and documentation ofthis training required for all staff,\nincluding veterinarians, who package and/or transport Category A, Division 6.2 (infectious)\nmaterials?\nAI: The staff and veterinarians who package and transport Category A infectious substances are\nrequired to have hazmat training. These requirements are prescribed in 49 CFR Part 172,\nSubparts H (training) and I (security) of the HMR, and apply to all hazmat employers,\nincluding those who are selfemployed, and hazmat employees who transport hazardous\nmaterials in commerce. See § 171.1 (c) for the \"transportation functions\" description and\n§ 171.8 for the definitions of\"hazmat employer,\" \"hazmat employee,\" and \"hazardous\nmaterial.\" A hazmat employer must ensure that each of its hazmat employees has been\ntrained and tested, and create and retain a record oftheir current training as specified in\n§§ 172.702 and 172.704(d). Hazmat employees must be retrained at least every three years.\nThe HMR are available at \"www.ecfr.gov\" under Title 49, Parts 1 00-180, or through the\nregulations portion of our web site at ''http://hazmat.dot.gov.''\nThe standard hazmat training requirements of the HMR consist of five parts: (1) general\nawareness; (2) function-specific; (3) safety; (4) security awareness training; and, when\ntransporting certain high hazard materials such as select agents, 5) in-depth security training\n(see § 172.704(a»). Additional training requirements or exceptions to this training are\nprescribed throughout the HMR based on the risks a hazardous material poses in\ntransportation and other safety factors, such as its packaging, employee knowledge of the\n\n<<<PAGE 2>>>\n\nmaterial, or operational effects on a material or packaging that may occur in a specific mode\nof transportation.\nOn October 1,2010, the Pipeline and Hazardous Materials Safety Administration (PHMSA)\nrevised the requirements for in-depth security training (see Docket Nos. PHMSA-06-25885\n(HM-232F; 75 FR 10974) and PHMSA-201O-0195 (HM-244C; 75 FR 53593). These\nchanges include requiring that in-depth training contain information on organizational\nsecurity structure; specific security responsibilities for each employee; specific actions to be\ntaken by each employee if a security breach occurs; and expanded the list of materials that\nrequire a security plan. They also include requiring that the plan contains an assessment of\nthe site and location-specific risks at the facilities where these materials are being prepared,\nstored, or unloaded in transportation. Further, they expand the information that must be\nincluded in the plan, require it to be reviewed annually, and require that all employees\nresponsible for implementing the plan be notified when the plan is updated or revised. See\n§§ 172.704(a)(5), 172.800(b), and 172.802. If this in-depth security plan is revised within\nthe three-year recurrent training period, hazmat employees must receive training on the\nrevised plan within 90 days of its implementation (see § 172.704(c)(2».\nQ2: Is informal hazmat training and documentation of this training required for all staff,\nincluding veterinarians, who package and/or transport Category B, Division 6.2 (infectious)\nmaterials?\nA2: A \"UN 3373, Biological substance, Category B\" infectious substance must be transported in\nconformance with the requirements prescribed in §§ 173.134 or 173.199 of the HMR. A\nCategory B infectious substance that meets the exceptions prescribed in § 173.134(b), such\nas patient samples transported for research, or human or animal samples transported for\nroutine testing, is excepted from all other requirements of the HMR, including those for\nhazmat training, provided the package conforms with the conditions required for the\nmaterial in § 173 . 134(b ). A hazmat employee that offers or transports a waste culture or\nstock of a Category B infectious substance as a \"UN 3291, Regulated medical waste, n.o.s.,\n6.2, PG II\" in the manner prescribed in § 173. 134(c)(2) must be hazmat trained. Category B\ninfectious substances packaged in conformance with § 173.199 need only be trained on, and\ncomply with, the requirements in that section (see § 173.199(e».\nQ3: Most clinics package and transport Category B infectious substances on a routine basis. If\nindividuals who package these materials have not had the required training, is it imperative\nthat they receive this training immediately and that this training is documented? Will clinics\nshipping Category A infectious substances need to have responsible staff formally trained on\ntransporting these materials?\nA3: Unless otherwise excepted, individuals who perform pre-transportation and transportation\nfunctions for Category A or B infectious substances for transportation in commerce are\nhazmat employees and must be hazmat trained before performing these tasks. A record\nmust be made of this training, as described in Answers Al and A2. Hazmat employees\nperforming these tasks without this training may be in violation of the HMR. Enforcement\nprocedures and civil penalty guidelines for violations of the HMR are prescribed in 49 CFR\n2\n\n<<<PAGE 3>>>\n\nPart 107, Subpart D. However, the HMR permit a new employee to perform regulated\nfunctions and activities prior to the completion oftraining provided the employee performs\nthe functions under the direct supervision of a properly trained and knowledgeable hazmat\nemployee, and the new employee's training is completed within 90 consecutive days from\nthe first time they perform a regulated function. See § 171.1 (b) and ( c), and § 172. 704( c)( 1).\n\"Direct supervision\" consists ofthe supervising employee instructing the new employee\nhow to properly perform the hazmat function, observing the employee's performance ofthe\nfunction, and being able to take corrective action with regard to any function not performed\nin conformance with the HMR.\nQ4: Is each clinic responsible for maintaining the hazmat training record of its employees for at\nleast three years for each employee it has trained to package these materials?\nA4: Each hazmat employer must create and retain a record ofcurrent hazmat training, inclusive\nofthe preceding three years, for each hazmat employee for as long as that employee works\nfor that employer, and for 90 days after the employee stops working for that employer, as\nspecified in § 172.704(d). However, the HMR do not specify the location of the training\ndocuments, provided they are retained by the hazmat employer. Therefore, they may be\nretained at an individual clinic or at a clinic's parent company headquarters. Wherever they\nare retained, under 49 U.S.C. § 5121(b)(2), a hazmat employer must make the required\ntraining documentation specified in § 172.704(d)(l) through (d)(5) available for inspection\nto a designated officer, employee, or agent ofthe Secretary of Transportation when the\nSecretary or his authorized representative conducts an investigation or makes a request. In\naddition, a hazmat employer must make the security plan prescribed in 49 CFR Part 172,\nSubpart I, available upon request to an authorized official ofthe Department of\nTransportation or the Department of Homeland Security (see § 172.802(d).\nQ5: Must hazmat training records be made available to the proper regulatory authorities upon\nrequest?\nA5: See A4.\nQ6: Does the PHMSA publication \"What You Should Know: a Guide to Developing a\nHazardous Materials Training Program\" provide valuable information and resources,\nincluding sample training records?\nA6: PHMSA's Hazardous Materials Training Program guidance document explains the training\nrequirements in the HMR, identifies those employees who must be trained, and provides\nseveral tools, including a sample employee training record, to help hazmat employers\ndevelop and implement an effective training program for their employees. If you have not\nalready done so, you may also want to consult our publications entitled 1) \"Transporting\nInfectious Substances Safely,\" 2) \"Enhanced Security Requirements (however, the list of\nmaterials that require this training has changed - see Answer AI),\" and 3) \"Does Your\nHazmat Training Measure Up?\" In addition, you may also find our interactive compact\ndisks (CDs), entitled \"Hazmat General AwarenesslFamiliarization Training,\" and \"Hazmat\nTransportation Security Awareness Training Module Revised,\" helpful. These publications\n3\n\n<<<PAGE 4>>>\n\nmay be downloaded from our website or ordered, along with the CDs, at\n\"https:llhazmatonline.phmsa.dot.gov/services/\" under the link for \"Training Materials and\nPublications.\" However, please note these materials must not be used as a substitute for the\nrequirements prescribed in the HMR.\nI hope this satisfies your request.\nSincerely,\n~/~~-\nT. Glenn Foster\nChief, Regulatory Review and Reinvention Branch\nStandards and Rulemaking Division\n4\n\n<<<PAGE 5>>>\n\nDrakeford, Carolyn (PHMSA)\nFrom: Betts, Charles (PHMSA)\nSent: Friday, September 03, 2010 1:46 PM\nTo: Drakeford, Carolyn {PHMSA}\nCc: Simon, Candace (PHMSA); Foster, Glenn (PHMSA)\nSubject: FW: Questions about training -- infectious substances Cat. A & B\nFrom: Dr. Kristi Henderson [mailto:KHenderson@avma.org]\nSent: Tuesday, August 17, 2010 12:34 PM\nTo: training (PHMSA)\nSubject: Questions about training -- infectious substances cat. A & B\nMy name is Dr. Kristi Henderson, and I am one of the veterinarians on staff with the American Veterinary Medical\nAssociation (AVMA) working with various topics, including those related to packaging and shipping of veterinary medical\nsamples. The AVMA and its membership need guidance on the type of training and documentation of such required for\nveterinary practices I clinics I hospitals sending samples that fall within Category A or Category B infectious substances\nbecause we have had questions from our membership about them.\nThe following is some of the information that we have recently compiled on our website at\nhttp://www.avma.orq/issues/pack ship lab specimens.asp pertaining to specimen shipping. Can you tell me if the\nfollowing bullet points are correct, or if DOT recommends any edits, corrections, or additions? Other thoughts??\n• Category A: Specific formal training and documentation of it is required for all staff (including\nveterinarians) who package or transport items in this category.\n• Category B: Training and documentation of it is required for all staff {including veterinarians} who\npackage or transport items in this category; however, the training may be informal and in-house.\n• Most clinics package and ship Category B items on a routine basis. If the individuals who package these\nitems have not had the required training, it is imperative that they receive it immediately and that the\ntraining is documented. Any clinics shipping Category A items will need to have the responsible staff\nformally trained on the subject.\n• Each clinic is responsible for maintaining the training record for at least 3 years for each employee trained\nto package these substances.\n• Training records must be made available to the proper regulatory authorities upon request.\n•\nrecords.\nAny guidance you can provide regarding this will be greatly appreciated.\nSincerely,\n'l(risti Jfenaerson, qy~;W\nAssistant Director, Scientific Activities\nAmerican Veterinary Medical Association\n1931 N. Meacham Road, Suite 100\nSchaumburg, IL 60173\nPhone: 847-285-6651 or 800-248-2862 x 6651\nFax: 847-925-9329\nKHenderson@avma.org\nwww.avma.org\nhttps:llwww.avmanetwork.org/default.aspx\n1","truncated":false,"body_characters":12353}