{"operation":"document","citation":"08-0078","title":"Covance Laboratories, Inc. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2008-05-23","effective_on":null,"summary":"08-0078 response to Covance Laboratories, Inc. concerning 172.704.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-08-0078.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-08-0078.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-08-0078","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2008/080078.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nof Transportation\nPipeline and Hazardous\nMaterials Safety\nAdministration\nI-%! 2 3 2008\n1200 New Jersey Avenue, SE\nWashington. D.C. 20590\nMs. Dee Kaiser\nEHS Manager\nU.S. Clinical Pharmacology\nCovance Laboratories, Inc.\n3301 Kinsman Boulevard\nMadison, WI 53704\nReference No. 08-0078\nDear Ms. Kaiser:\nThis is in response to your March 20,2008 e-mail and recent telephone conversations with a\nmember of my staff asking if your company's small network of extensively trained hazmat\nemployees, herein described as \"designated employees,\" may provide the company's other\nhazmat employees with the training they need to prepare and offer for transport materials, and\naccommodate transport conditions, not covered in their initial training under the Hazardous\nMaterials Regulations (HMR; 49 CFR Parts 171 -1 80). You also ask if it would satisfy the\ntraining requirement for the designated employee to provide the employee needing this\ninformation with the correct packaging instructions and a completed shipping paper with a\nsigned shipper's certification.\nYou state the employees needing this information are located at multiple clinic sites\nthroughout the United States, and have received hazmat training that covers most conditions\nencountered when transporting exempt human specimens, exempt quantities of \"UN 1845,\nDry ice, 9 (miscellaneous), PG 111,\" and \"UN 3291, Regulated medical waste, n.o.s., 6.2\n(infectious), PG 11\" by motor vehicle. You also state the designated employees may not be\nlocated at each of these sites, and the packages may need to be transported by aircraft.\nAlthough self-training is acceptable and may be used, a packaging instruction and certified\nshipping paper are in themselves not \"training\" under the HNIR and may not be sufficient to\nprovide the knowledge level necessary to prepare a hazardous material package for\ntransportation in accordance with the HMR. In addition, each hazmat employer must certify\nthat each of its h m a t employees has been trained and tested, as required. No specific testing\nmethod or document is required. The requirements in Subpart H of Part 172 do not state that\nan employee must \"pass\" a test; however, a hazmat employee may only be certified in those\nareas in which the hazmat employee can successfully perform the assigned duties. A record\nof current training must be created and retained by each hazmat employer as specified in 49\nCFR 172.704(d).\n\n<<<PAGE 2>>>\n\nThe purpose of the training requirements is to ensure that each hazmat employer trains each\nhazmat employee. There are no provisions or procedures under the training requirements for\nreview or approval of training programs or certification of instructors. A hazmat employer\nmust determine the most suitable method (e.g., hands-on demonstrations, online training, or\ninteractive CD's) and source of training for its employees.\nI hope this satisfies your request.\nHattie L. Mitchell\nChief, Regulatory Review and Reinvention\nOffice of Hazardous Materials Standards\n\n<<<PAGE 3>>>\n\nFrom: Kaiser, Dee [mailto:Dee.Kaiser@covance.com]\nSent: Thursday, March 20, 2008 11:24 AM\nTo: Edmonson, Eileen <PHMSA>\nSubject: Hazmat Employee Training Requirements\nHi Eileen,\nThis is a follow-up to our conversation earlier this week regarding hazmat employee training. We\nhave multiple small clinical sites across the US, and have provided hazmat employee training\ninternally to cover general awareness, safety, security, and function-specific training\ntopics pursuant to 49 CFR 172, Subpart H. The function-specific training covers preparing and\noffering exempt human specimens (that may include exempt quantities of Class 3 liquids or\nDivision 6.1 solids or liquids), dry ice, and regulated medical waste, and transport by motor\nvehicle. Training emphasizes their function limitations and that additional training is needed\nbefore performing other functions, and who to contact for assistance (our training includes testing\non these restrictions).\nOn occasion we may need to ship other hazardous materials from the clinical sites that is not\ncovered in this training. There is a small \"network of designated employees who have\ncompleted more comprehensive 49 CFRIIATA training for classification and shipment of\nhazardous materials encountered in our business, but they are not located at each site. Are there\noptions for any of these designated employees to provide specific packaging\ninstruction/certification not already covered in our hazmat employee training to the shipper at the\nremote site? For example, would we be compliant with 49 CFR 172, Subpart H if the designated\nand trained indivduals provided the site requestor with proper packaging instructions (hazard\nclass, packaging, marking, labeling, etc.) and generatedtsigned the shippers certification?\nWe are interested in your thoughts or other recomendations to ensure conformance with hazmat\nemployee training requirements, or if you know what other companies do under similar\ncircumstances. Thank you in advance for your assistance.\nDee Kaiser\nEHS Manager, US Clinical Pharmacology\nCovance Laboratories Inc. 1 3301 Kinsman Blvd. I Madison, WI 53704\nTel: 608.242.2712 k t . 2528 1 Fax: 608.242.2706\ne-mail: dee. kaiser Qcovance.com\n.....................................................\nConfidentiality.Notice: This e-mail transmission\nmay contain confidential or legally privileged\ninformation that is intended only for the individual\nor entity named in the e-mail address. If you are not\nthe intended recipient, you are hereby notified that\nany disclosure, copying, distribution, or reliance\nupon the contents of this e-mail is strictly prohibited.\nIf you have received this e-mail transmission in error,\nplease reply to the sender, so that we can arrange\nfor proper delivery, and then please delete the message\nfrom your inbox. Thank you.","truncated":false,"body_characters":5844}