Stericycle, Inc. — Hazardous Materials Safety Interpretation

Page 1400 Seventh Street, S.W. Washington, D.C. 20590 Hazardous Materiais Safety Pipeline and Administration MAR 19 2007 Stericycle, Inc. Ms. Selin Hoboy Ref. No. 07-0057 2333 Waukegan Road Bannockburn, Illinois 60015 Dear Ms. Hoboy: This responds to your March 9, 2007 letter requesting clarification of the requirements for Fans 171-80: Specially, youst about the caption Ms 173l Rey apie MR: 49 CER transportation of waste cultures and stocks and for clarification of the types of ma erials that may be transported on the same vehicle as waste cultures and stocks in accordance with the exception. The exception in § 173.134(c)(2) permits a waste stock or culture of a Category B infectious substance to be offered for transportation and transported as a regulated medical waste when it is packaged in a rigid non-bulk packaging conforming to the general packaging requirements of transported by a private or contract carrier in a vehicle used exclusively to transport regulated 8§ 173.24 and 173.24a and packaging requirements specified in 29 CFR 1910.1030 and medical waste. As your letter notes, in a final rule published [insert date] under docket number HM-226A, we amended the language in this section to insert the phrase "used exclusively to transport regulated medical waste" in place of the phrase "dedicated to the transportation of regulated medical waste" The change in terminology in § 173.134(c)(2) was intended to be a non-substantive editorial change to standardize terminology used throughout the HMR. The terms "dedicated" and "used transport of radioactive materials. As used in the HMR, the terms "dedicated" and "used exclusively" are synonymous. "Exclusive use" is not defined in the HMR, for other than exclusively" mean the vehicle is used for the transportation of a single commodity or class of commodities. According to your letter, it is difficult to identify and segregate waste cultures and stocks from indicate that waste generators may ask Stericyle to transport other types of medical waste in Plant and animal waste regulated by the Animal and Plant Health Inspection Service, U.S. Department of Agriculture; 070057 173.134#

Page 2• Waste pharmaceutical materials; • Laboratory and recyclable wastes, such as fixer/developer, amalgam, lead foil, and disinfectant materials; • Infectious substances, including Category A infectious substances, that have been treated to eliminate or neutralize pathogens; • Forensic materials being transported for final destruction; • Rejected or recalled health care products; and • Documents intended for destruction in accordance with HIPAA requirements. of medical waste. You indicate that all these waste materials are transported to facilities designated for the disposal stocks to be transported as regulated medical waste in a rigid non-bulk packaging conforming to As described above, the exception in § 173.134(c)(2) permits Category B waste cultures and vehicle used exclusively to transport regulated medical waste. An exclusive-use vehicle is one certain general packaging requirements when transported by a private or contract carrier in a used for the transportation of a single commodity or class of commodities; transportation in an exclusive-use vehicle in accordance with the exception prevents inadvertent contamination of other types of materials, including non-medical waste materials. The operations you describe for the transportation of waste cultures and stocks appear to meet the intent of this exception. While the materials you transport on the same vehicle as waste cultures and stocks are not regulated medical waste, as that term is defined in the HMR, all the materials are considered medical waste and are transported to facilities designated by local authorities and designed for the disposal of medical waste. Further, under § 173.134(c)(2), you may transport medical or clinical equipment and laboratory products on the same vehicle as the waste cultures and stocks covered by the exception, provided they are properly packaged and secured against exposure or contamination. The term "laboratory products" is not defined in the HMR. However, the materials you describe are generated from laboratories and health care facilities and, thus, may be considered laboratory products for the purposes of the exception. Therefore, it is the opinion of this Office that the transportation operation you describe is consistent with the terms of the exception in § 173.134(c)(2). Therefore, you may transport the cultures and stocks. types of medical waste described in your letter on the same vehicle you use to transport waste#

Page 3I hope this information is helpful. Please let me know if I can be of further assistance. Sincerely, Susan corsk Regulations officer Office of Hazardous Materials Standards#

Page 4Stericycle ® Experts in Infection Control and Healthcare Compliance Services March 9, 2007 horsku {|73. 13 Mr. Edward Mazzullo, Director Office of Hazardous Materials Standards Exceptions for Medical Waste PHH-10 400 Seventh Street, S. W 07-0051 Washington, DC 20590 RE: FINAL RULE HM 226A - INTERPRETATION OF "EXCLUSIVE" MEDICAL WASTE CARRIER UNDER 49 CFR 173.134 Dear Mr. Mazzullo: I am writing in reference to a recent language change under Final Rule HM 226A. In this final rule there is a section relating to the transportation of regulated medical waste. Specific section reference is 49 CFR 173.134 (c)(ii)(2) "[Category B waste culture or stock] transported as regulated medical waste when it is packaged in a rigid non-bulk packaging requirements under 29 CFR 1910.1030 and transported by a private or contract packaging conforming to the general packaging requirements of 173.24 and 173.24a and carrier in a vehicle used exclusively to transport regulated medical waste." Prior to this change the term "dedicated" was used instead of "exclusively". Based on the literal interpretation of these regulations it would mean that materials other than regulated medical waste could not be on the vehicle at the same time. Although, we recognize that the mixed cultures and stock materials which may be present in the containers is minimal and often more specifically from lab type environments, the potential still exists. It is also typical that wastes generated in these environments are the way that generators package their waste to take advantage of this exception, it would pretreated prior to being disposed of in the regulated medical waste. However, due to be difficult to ensure exclusivity for these materials alone. We are requesting clarification that this new term does not change the intent of the regulation. dedicated to the transport of regulated medical waste, other materials could be present on Prior to this, the interpretation was that as a private carrier, primarily the vehicle. However, there are other waste streams that are transported as a service to generators for the safe and efficient transport of their waste materials. All drivers and these other waste materials. This provides generators with an efficient anc compliant employees are fully trained on the proper handling, transport and emergency response to option for transporting their wastes. Other such wastes which generator's may request to be transported that are not necessarily regulated medical waste by definition may include: • US Department of Agriculture - Animal and Plant Health Inspection Service - and are required to have specific packaging, documentation and destruction Wastes defined under 7 CFR as regulated garbage, including plant and an:mal waste, requirements 2333 Waukegan Road, Suite 300 • Bannockburn, IL 60015 • • • www.stericycle.ccm Stericycle, Inc.#

Page 5• Waste pharmaceuticals - pharmaceutical materials which are meant for final accordance with regulations and separately documented as required destruction and no longer have value by manufacturer definition; packaged in • Lab and Recyclable wastes - for example fixer/developer for recycling, amalgam for recycling, lead foil for recycling, disinfectant materials etc. - Packaged in accordance with regulations and separately documented as required • Treated Category A infectious substances which generators chose to over classify Documents for destruction under HIPAA requirements • Evidence materials - non weapon law enforcement materials sent for final destruction • Off specification products from manufacturers due to rejection or recal., normally considered solid waste, which is transported for destruction Current needs of the industry and generators are that other waste streams, which are also classitied, marked and packaged appropriately, could be transported with regulated responsible disposal of these materials. We would like to clarify that these additional waste materials can be transported with questions at 847-943-6685/shoboy@stericycle.com. Sincerely, Selin Hoboy Stericycle, Inc CC: Deputy Robert A. Richard - Deputy Associate Administrator for Hazardous Materials Safety Joseph Solomey - Assistant Chief Counsel for Hazardous Materials Safety Office of Chief Counsel. Alice Jacobson, Medical Waste Institute#