{"operation":"document","citation":"09-0011","title":"Association of Clinical Research Professionals — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2009-07-08","effective_on":null,"summary":"09-0011 response to Association of Clinical Research Professionals concerning 173.199.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-09-0011.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-09-0011.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-09-0011","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretations/2009/090011.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nof Transportation\nPipeline and Hazardous Materials\nSafety Administration\n1200 New Jersey Ave., SE\nWashington, DC 20590\nMr. David Vulcano\nChair, ACRP Board of Trustees\nAssociation of Clinical Research Professionals\n500 Montgomery Street, Suite 800\nAlexandria, VA 22314\nReference No. 09-0011\nDear Mr. Vulcano:\nThis is in response to your January 7, 2009 letter concerning the training requirements for\nhazmat employees who prepare and package only Category B infectious substances (Division\n6.2) in conformance with $ 173.199 of the Hazardous Materials Regulations (HMR; 49 CFR\nParts 171-180). You ask if the HMR excepts these employees froin all other training\nrequirements under the HMR if they are trained to carry out the provisions of this section.\nThe answer is yes. Employees trained to know and carry out the requirements prescribed in\n$ 173.199 for Category B infectious substances are excepted from all other training\nrequirements under the HMR when preparing and offering these materials for transportation\nin commerce. See $ 173.199(a) and (e).\nYou also ask if the learning objectives and methods your association is considering (i.e., a\npaper-based self-training module, a post test, recurring 3-year training, and a record keeping\nsystem) to satisfy the training requirements in $ 173.199 are sufficient andlor correct. It is the\nopinion of this Office that the training scenario you present is sufficient as long as all of the\nprovisions of $173.199 are covered. Section 173.199 stipulates that persons who offer and\ntransport these packages in commerce must be knowledgeable about the requirements of this\nsection. See $ 173.199(e).\nI hope this information satisfies your request.\nSincerely, ,\nHattie L. Mitchell\nChief, Regulatory Review and Reinvention\nOffice of Hazardous Materials Standards\n\n<<<PAGE 2>>>\n\nGLOBAL HEADQUARTERS\nWASHINGTON, DC\noffices in:\nWindsor, UK\nPune, India\n500 Montgomery St. Suite 800\nAlexandria, VA 22314 USA\nT) 703-254-8100\nF) 703-254-8101\nE) officeQacrpnet.org\nJanuary 7,2009\nU.S. Department of Transportation\nPHMSA Office of Hazardous Materials Standards\nAttn: PHH-10\nEast Building\n1200 New Jersey Avenue, SE\nWashington, DC 20590-0001\nRE: Request for Guidance or Interpretation on 49CFR173.199 (Category B Infectious\nSubstances)\n.. .\n! .. ; .,. . . .. i. : , . - I . . . .\nhe ~ssdeiatiori of CliriiCal ~ k k i t k h Piofessibna~s (ACRP) is~a'p~bfe&id~21:&isoc-iation of\n, .. ,,,. . .,\n~~r'-20~000'menibki~,nios't . r . within theunited states. t very li@epeken't od:oij+ :\nm ~ m b e r ' i a ~ c t i ~ i t ' y ~ i ~ v o l v e ~ c l i n i c a l trials that drawlib sbecimeniforcliagnostit purposes\nthat fit in the definition of Category B lnfectious Substance. As many of these studies\nare multi-center studies, it is not uncommon for our members to be asked to ship lab\nspecimens to a \"central lab\" that is contracted by the sponsor of a particular clinical\ntrial. 'the usual course of action is to draw the specimen and ship (with or without Dry\nIce) via commercial couriers such as FedEx, UPS etc. As regulations for Category B\nspecimens have seen several drastic changes over the past 7 years, there remains a\ntremendous amount of myth and opinions surrounding the trail?ing requirements to\nperform this task.\nYears ago when these was no \"Category B\" or \"Diagnostic Specimen\" designation in the\nHMT, people went through great expense to receive full hazmat training as required by\n49CFR172.700 to ship any biological specimen. Through a series of events,\npharmaceutical companies and other clinical trial sponsors gained a heightened\nawaren.ess and required assurance that their research site's staff \"certification\".\nAlthough the'laws have changed since then, there are still legacy interpretations and\nck;kliiti'out there as well as sales pressure from for-profit education prdvide'rs t o ,\npursue full hazmat training for hazmat \"certification\". Many of our members do not\nbelieve that this is necessary and I seek your clarifications so that we may foster a more\nuniform approach to this issue, in full compliance with the law. The prevailing\ninterpretation and proposed training is described in the subsequent paragraphs. I have\ncontacted HazMat helpline several times since 49CFR173.199 was rewritten and\nOUF Mission: TO provide global leadership to promote integrity and excellence for the clinical research profession.\n\n<<<PAGE 3>>>\n\nU.S. Department of Transportation\nPHMSA Office of Hazardous Materials Standards\nPage 2\nJanuary 7, 2009\nRE: Request for Guidance or Interpretation on 49CFR173.199 (Category B lnfectious\nSubstances)\nreceived agreement with the below interpretation. As our industry always appreciates\nwhen the FDA puts their guidance in writing, it was suggested that I send this request to\nyou so that I may have a formal, written interpretation.\n49CFR172.700 describes the training that a \"HazMat\" employee must undergo prior to\nundertaking their duties. The regulation states that the employee must be \"trained\"\n[.702(a)] and \"tested\" [.702(d)] on the specific requirements (as listed in .704) pertaining\nto hazardous materials. There are also requirements set forth regarding recordkeeping\nof such training, specifically .704(d)(5) stating \"Certification that the hazmat employee\nhas been trained and tested, as required by this subpart\". Finally, the regulations state\nthat the employee should receive training every 3 years [.704(c)(2)].\nWhile such intense training is required for a person handling Category A lnfectious\nSubstances, we read in the regulations pertaining to Category B Infections Substances\n[49CFR173.199(a)] that \"Category B infectious substances are excepted from all other\nrequirements of this subchapter when offered for transportation or transported in\naccordance with this section\". We interpret this as meaning that the requirements of\n49CFR172.700 do not apply when an individual shipping Category B lnfectious\nSubstances is trained under .199(e), which only requires that \"Each person who offers or\ntransports a Category B infectious substance under the provisions of this section must\nknow about the requirements of this section\". Given that, we interpret this as an\nindividual who only packages Category B lnfectious Substances for shipment does not\nneed the full \"certification\" that the hazmat employees shipping Category A substances\nrequire but, instead, needs to demonstrate awareness of the content of 49CFR173.199.\nAssuming our prevailing interpretation is correct (that full hazmat training as required\nby 49CFR172.700 is not required for those only shipping Category B lnfectious\nSubstances that meet the training requirement of 49CFR173.199(e)), we request an\nopinion on if a paper-based self-training module that had the following learning\nobjectives would be sufficient to meet the requirements of 49CFR199(e).\n1) The trainee shall be able to differentiate between Category A and Category B\nlnfectious Substances.\n2) The trainee will demonstrate knowledge that the subsequent training is only\nadequate for the packaging and shipping of Category B lnfectious Substances\nand that should they desire to pack or ship Category A lnfectious Substances,\nthey require additional training outside the scope of the module.\n3) The trainee will recall the requirements of 49CFR199(a)-(d).\n4) The trainee will recall the requirements of 49CFR173.217 (for dry ice).\n\n<<<PAGE 4>>>\n\nU.S. Department of Transportation\nPHMSA Office of Hazardous Materials Standards\nPage 3\nJanuary 7, 2009\nRE: Request for Guidance or Interpretation on 49CFR173.199 (Category B Infectious\nSubstances)\nWe also have 3 other considerations we would like comments on, assuming our\ninterpretation is correct.\n1) Although not required to be tested (as in 49CFR172.702(d)), we believe that a\npost-test would be a good suggestion to our members to deveiop in conjunction\nwith the training module.\n2) Although employees are not required to receive recurring training (as in\n49CFR172.704(~)(2)), we believe that our members should embrace the need for\nrecurring training in this area at the same three year interval by policy.\n3) Although recordkeeping is not required by 49CFR199(e), we believe that a\nrecordkeeping system should be suggested to our members in the form of\nmaintaining the names of the employees trained and their dates of training. This\nmay be accomplished by maintaining for each employee a copy of the training\nmodule attached to the dated and signed posttest (if applicable).\nOn behalf of over 20,000 clinical research professionals in the United States who want\nto do the right thing, I thank you for your attention to this matter so that we may\nprotect the safety of others through the compliant transport of Category B lnfectious\nSubstances while we pursue medical advances.\nLooking forward,\nDavid Vulcano\nChair, ACRP Board of Trustees\nDaytime Phone Number: (615) 268-2638","truncated":false,"body_characters":8892}