Covance Laboratories, Inc. — Hazardous Materials Safety Interpretation

Page 1U.S. Department of Transportation Pipeline and Hazardous Materials Safety Administration I-%! 2 3 2008 1200 New Jersey Avenue, SE Washington. D.C. 20590 Ms. Dee Kaiser EHS Manager U.S. Clinical Pharmacology Covance Laboratories, Inc. 3301 Kinsman Boulevard Madison, WI 53704 Reference No. 08-0078 Dear Ms. Kaiser: This is in response to your March 20,2008 e-mail and recent telephone conversations with a member of my staff asking if your company's small network of extensively trained hazmat employees, herein described as "designated employees," may provide the company's other hazmat employees with the training they need to prepare and offer for transport materials, and accommodate transport conditions, not covered in their initial training under the Hazardous Materials Regulations (HMR; 49 CFR Parts 171 -1 80). You also ask if it would satisfy the training requirement for the designated employee to provide the employee needing this information with the correct packaging instructions and a completed shipping paper with a signed shipper's certification. You state the employees needing this information are located at multiple clinic sites throughout the United States, and have received hazmat training that covers most conditions encountered when transporting exempt human specimens, exempt quantities of "UN 1845, Dry ice, 9 (miscellaneous), PG 111," and "UN 3291, Regulated medical waste, n.o.s., 6.2 (infectious), PG 11" by motor vehicle. You also state the designated employees may not be located at each of these sites, and the packages may need to be transported by aircraft. Although self-training is acceptable and may be used, a packaging instruction and certified shipping paper are in themselves not "training" under the HNIR and may not be sufficient to provide the knowledge level necessary to prepare a hazardous material package for transportation in accordance with the HMR. In addition, each hazmat employer must certify that each of its h m a t employees has been trained and tested, as required. No specific testing method or document is required. The requirements in Subpart H of Part 172 do not state that an employee must "pass" a test; however, a hazmat employee may only be certified in those areas in which the hazmat employee can successfully perform the assigned duties. A record of current training must be created and retained by each hazmat employer as specified in 49 CFR 172.704(d).#

Page 2The purpose of the training requirements is to ensure that each hazmat employer trains each hazmat employee. There are no provisions or procedures under the training requirements for review or approval of training programs or certification of instructors. A hazmat employer must determine the most suitable method (e.g., hands-on demonstrations, online training, or interactive CD's) and source of training for its employees. I hope this satisfies your request. Hattie L. Mitchell Chief, Regulatory Review and Reinvention Office of Hazardous Materials Standards#

Page 3From: Kaiser, Dee [mailto:Dee.Kaiser@covance.com] Sent: Thursday, March 20, 2008 11:24 AM To: Edmonson, Eileen <PHMSA> Subject: Hazmat Employee Training Requirements Hi Eileen, This is a follow-up to our conversation earlier this week regarding hazmat employee training. We have multiple small clinical sites across the US, and have provided hazmat employee training internally to cover general awareness, safety, security, and function-specific training topics pursuant to 49 CFR 172, Subpart H. The function-specific training covers preparing and offering exempt human specimens (that may include exempt quantities of Class 3 liquids or Division 6.1 solids or liquids), dry ice, and regulated medical waste, and transport by motor vehicle. Training emphasizes their function limitations and that additional training is needed before performing other functions, and who to contact for assistance (our training includes testing on these restrictions). On occasion we may need to ship other hazardous materials from the clinical sites that is not covered in this training. There is a small "network of designated employees who have completed more comprehensive 49 CFRIIATA training for classification and shipment of hazardous materials encountered in our business, but they are not located at each site. Are there options for any of these designated employees to provide specific packaging instruction/certification not already covered in our hazmat employee training to the shipper at the remote site? For example, would we be compliant with 49 CFR 172, Subpart H if the designated and trained indivduals provided the site requestor with proper packaging instructions (hazard class, packaging, marking, labeling, etc.) and generatedtsigned the shippers certification? We are interested in your thoughts or other recomendations to ensure conformance with hazmat employee training requirements, or if you know what other companies do under similar circumstances. Thank you in advance for your assistance. Dee Kaiser EHS Manager, US Clinical Pharmacology Covance Laboratories Inc. 1 3301 Kinsman Blvd. I Madison, WI 53704 Tel: 608.242.2712 k t . 2528 1 Fax: 608.242.2706 e-mail: dee. kaiser Qcovance.com ..................................................... Confidentiality.Notice: This e-mail transmission may contain confidential or legally privileged information that is intended only for the individual or entity named in the e-mail address. If you are not the intended recipient, you are hereby notified that any disclosure, copying, distribution, or reliance upon the contents of this e-mail is strictly prohibited. If you have received this e-mail transmission in error, please reply to the sender, so that we can arrange for proper delivery, and then please delete the message from your inbox. Thank you.#