MTS Medical Waste Management — Hazardous Materials Safety Interpretation

Page 1U.S. Department of Transportation Washington, DC 20590 1200 New Jersey Ave., S.B Pipeline and Hazardou: Administration Materials Safet JUL 1 0 2007 General Manager and Director Mr. Edward Petrullo Reference No. 07-0094 MTS Medical Waste Management 333 North Seventh Avenue Phoenix, AZ 85007 Dear Mr. Petrullo: This responds to your May 11, 2007 e-mail and May 31, 2007 telephone conversation with Ms. Eileen Edmonson of my staff concerning requirements in the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to the transportation of regulated medical waste (RMW). Specifically, you ask for a clarification of our letter to Ms. Selin Hoboy, Stericycle, Inc. (Reference No. 07-0057; March 19, 2007) concerning the dedicated vehicle exceptions in § 173.134(c)(2) of the HMR. The exception in § 173.134(c)(2) permits Category B waste cultures and stocks to be transported as regulated medical waste when packaged in a rigid non-bulk packaging carrier in a vehicle used exclusively to transport RMW. An exclusive-use vehicle is one used conforming to certain general packaging requirements and transported by a private or contract for the transportation of a single commodity or class of commodities. Transportation in an other types of materials, including non-medical waste materials. exclusive-use vehicle in accordance with the exception prevents inadvertent contamination of In our March 19, 2007 letter to Stericycle, Inc., on this subject, we addressed a question concerning the transportation of other types of materials on the same vehicle as Category B waste cultures and stocks: (1) plant and animal waste regulated by the Animal and Plant Health Inspection Service, U.S. Department of Agriculture; (2) waste pharmaceutical materials; (3) laboratory and recyclable wastes, such as fixer/developer, amalgam, lead foil, and disinfectant materials; (4) infectious substances, including Category A infectious substances, that have been treated to eliminate or neutralize pathogens; (5) forensic materials being transported for final destruction; (6) rejected or recalled health care products; and (7) locuments intended for destruction in accordance with HIPAA requirements. While no onsidered regulated medical waste, as that term is defined in the HMR, all of the liste materials are considered medical waste as that term is usually defined and, according to the information provided by Stericycle, are transported to facilities designated by local authorities and designed for the disposal of medical waste. Moreover, under § 173.134(c)(2), medical or clinical equipment and laboratory products may be transported on the same vehicle as the waste cultures and stocks covered by the exception, provided they are properly packaged anc secured against exposure or contamination. The term "laboratory products" is not defined i he HMR. However, the materials described earlier in this paragraph are generated fron 173.134 (c) 173.197 070094#

Page 22 laboratories and health care facilities and, thus, may be considered laboratory products for the purposes of the exception. For these reasons, we determined that the types of medical waste described in our March 19 letter may be transported on the same vehicle as waste cultures and stocks in accordance with the exception in § 173.134(c)(2). You ask whether soiled linen and laundry may also be transported on the same vehicle as Soiled linen and laundry are not medical waste and are not transported for disposal at a waste cultures and stocks under the exception provided in § 173.134(c). The answer is no. medical waste facility; further, soiled linen and laundry are not laboratory products as that term is used and understood for purposes of the HMR. Your email refers to the transportation of soiled healthcare linen on the same vehicle as ReMIN. Vino in this read shat the ke the in 1 7% not require is ply no of most. RMW to be transported on vehicles used exclusively for such transportation. For other than transported on the same vehicle as RMW. Thus, you may transport soiled healthcare linen, waste cultures and stocks, there are no restrictions on the types of materials that may be clean linen, hospital supplies, or other materials on the same vehicle as RMW, provided the shipment does not contain waste cultures and stocks. For purposes of the HMR, "culture" means an infectious substance containing a pathogen that is intentionally propagated. The term does not include human or animal material collected directly from humans or animals and transported for research, diagnosis, investigational activities, or disease treatment or prevention, such as excreta, secreta, blood and its components, tissue and tissue swabs, body parts, and specimens in transport media (e.g., transwabs, culture media, and blood culture bottles). (See § 173.134(a)(3) and (a) (4).) Care should be taken, however, when transporting materials on the same vehicle as RMW. The surfaces of packages containing non-contaminated items may become contaminated by direct or indirect contact (e.g., transfer or aerosolization) with pathogenic materials emitted from or on the surface of RMW packages, or their transport containers or transport vehicles. when they come in contact with hands or tools used to open them. We recommend when such As a result, the clean items within the packages may inadvertently become contaminated transportation occurs that shippers and carriers take steps to prevent the contamination of the outer surface of these packages. I hope this satisfies your request. Sincerely, Susan Gorsky Dure Dy Regulations Officer Office of Hazardous Materials Standards 2#

Page 3Edmonson 5173.197-5173.134 Regulated Medical Waste Edmonson, Eileen <PHMSA> 07-0094 From: healthcare@milumtextileservices.com Sent: Friday, May 11, 20072:09 PM To: Edmonson, Eileen <PHMSA> Subject: Follow-Up On RMW Transport Interpretations Hello Eileen, It was very nice seeing you again in Atlanta. Been many years it seems from the time in San Diego. Here below I am copying the e-mail I just sent to William Stevens, Senior Hazardous Materials for a Permit or Exclusion? It seems to me that in the U.S. there are relatively few "Destination/or Designated Facilities" than receive, store, and process everything on a truck carrying RMW. Case in point is that even if just RMW and no linen or HIPPA documents, the incinerables are going to go to another facility and maybe that facility is in a different state. Please read my letter below, and then tell me what we should do. Thank you very much........ I would like to correspond with you so that I may work through some of the issues discovered while you Hello Mr. Stevens, Initially, I would like you to summarize for me the "designated vehicle" issue we discussed with the CFR and I discussed RMW transport in length thursday after the Medical Waste conference in Atlanta. sites, so that I may look them up and re-familiarize myself with them. You will remember that we discussed transporting RMW with healthcare linen. We have two plants within 15 miles of one another and so the unloading of the RMW first and then traveling to the laundry plant to unload the soiled healthcare linen is the most efficient for our small operation. I understand fixer/developer, HIPPA docs, and healthcare linen may be transported together with RMW. You made that there is an interpretation recently that Stericycle has in writing saying that some materials like consensus and through the last 10 years or so, we have had opinions from the State authorities and the point that you would write a violation for such activity, I believe. We would of course like to have a some at the D.O.T. that stated that these materials we deal with are very similiar in waste characteristics/soil, and with proper packaging and segregation that they are homogeneous for transport. I appreciate your taking the time to assist us with this. Two questions before I close: with the W.H.O. Has there? 1) I wonder also if there has the been a change in the regs or interpretations due to the re-alignment 2) Can RMW be manifested on a "Bill of Lading" using the words "Non-hazardous Waste"? I look forward to the CFR reference locations for our education and your opinion concerning these areas of concern. Thanks Edward Petrullo, General Manager & Director MTS MEDICAL WASTE MANAGEMENT, a division of Milum Textile Services 5/14/2007#

Page 4Page 2 of 2 email: healthcare@milumtextileservices.com website: www.milumtextileservices.com efax: 1-866-754-6583; fax: 602-253-3819 888 or 602-253-5173; cell 602-620-3004 5/14/2007#