National Solid Wastes Management Association — Hazardous Materials Safety Interpretation

Page 1.S. Departmer f Transportatio 400 Seventh Street, S.V Washington, D.C. 2059( Pipeline and Hazardous Materials Safety APR 26 2007 Administration Ms. Alice P. Jacobsohn Reference No. 06-0277 National Solid Wastes Management Association Director, Medical Waste Institute 4301 Connecticut Avenue, NW, Suite 300 Washington, DC 20008 Dear Ms. Jacobsohn: the requirements for transporting "Regulated medical waste, 6.2 (infectious), UN 3291, PG This corrects our January 18, 2007 response to your November 30, 2006 letter concerning Parts 171-180) that were revised in June and December 2006 to harmonize them with Il" (RMW) prescribed in sections of the Hazardous Materials Regulations (HMR; 49 CFR international requirements. See Docket Nos. PHMSA-06-25476 (HM-2151, 12/29/06, 71 FR 78595) and PHMSA-2004-16895 (HM-226A, 6/1/06, 71 FR 32243). The correction concerns our original response to your questions concerning the exceptions authorized in § 173.134(c)(2) for the transportation of waste cultures and stocks. We have paraphrased the questions in your November 30, 2006 letter and answered them in the order provided. Q1 The final rule issued under Docket No. HM-2151 changes the sequence of information required to describe a hazardous material on a shipping paper. but not the sequence of information required on a package marking and label. Is our understanding correct? Al. § 172.202(b) to require the UN identification number of a hazardous material to Yes. effective January 1, 2007, the final rule issued under Docket HM-2151 revised appear first in its basic description on a shipping paper followed by its proper shipping name, hazard class and packing group for consistency with international requirements. Under $ 171.14(e), this new shipping description sequence is mandatory as of January 1. 2013. The sequence of marking and labeling requirements for a hazardous material under the HMR remain unchanged. Q2. Under Docket No. HM-226A, the letter "G" was added in Column I alongside the 172.101(b)(4) requires that HMT entries denoted with this symbol must have the entry on the Hazardous Materials Table (HMT: § 172.101), for RMW. Section 172.101 173-1346)E) 060277 172.203 (k)#

Page 2for RMW and this makes compliance with this requirement difficult. Under Docket No. HM-215I the letter "G" no longer appears alongside this entry. Does the removal of this notation mean a technical name is no longer required as part of the RMW proper shipping description? A2. Yes. Q3. Medical waste haulers collect hazardous materials that cannot be separated from RMW, such as contaminated chemotherapeutic wastes the U.S. Environmental these materials are packaged and disposed of in compliance with the requirements Protection Agency also requires to be manifested as hazardous waste. Currently, for their hazard class under the HMR, but may not be transported on the same vehicle as waste cultures and stocks transported in accordance with § 173.134(c)(2). Would the Pipeline and Hazardous Materials Safety Administration (PHMSA) consider expanding this exception to include RMW that may also meet the definition of another hazard class? The Medical Waste Institute (MWI) asserts there is no change or increase in risk by allowing these substances to be transported onboard the same vehicle with RMW when these materials are packaged for their hazard class and transported to facilities designed to handle these materials in conformance with the HMR. A3. The exception in § 173.134(c)(2) permits Category B waste cultures and stocks to be transported as RMW in a rigid non-bulk packaging conforming to certain general packaging requirements when transported by a private or contract carrier in a vehicle used exclusively to transport regulated medical waste. An exclusive-use commodities; transportation in an exclusive-use vehicle in accordance with the vehicle is one used for the transportation of a single commodity or class of exception prevents inadvertent contamination of other types of materials, including other RMW that also meets the definition of another hazard class on the same non-medical waste materials. The transportation of chemotherapeutic waste and vehicle as Category B waste cultures and stocks is consistent with the intent of this exception and, therefore, is permitted under current regulatory requirements. 04. Under 7 CFR 330.400, the U.S. Department of Agriculture, Plant and Animal Health Inspection Service (APHIS), arranges compliance agreements for the proper disposal of plant and animal materials imported into the United States. The agreements include specific requirements for handling and disposing of these materials, also known as"regulated garbage," such as inspections by APHIS agents and the use of leakproof covered receptacles. These materials go to the same disposal facilities as those for RMW, but under the HMR cannot be placed on the same vehicle with RMW and take advantage of the dedicated-exclusive use vehicle exception for RMW waste cultures and stocks prescribed in § 173.134(c)(2). Would PHMSA consider expanding this exception to include APHIS regulated garbage? MWI asserts there is no change or increase in risk by allowing these substances to be transported onboard the same vehicle with RMW when these to handle these materials in conformance with the HMR. materials are packaged for their hazard class and transported to facilities designed 2#

Page 3A4. As indicated above, the intent of the exception in § 173.134(c)(2) is to prevent inadvertent contamination of other types of materials, including non-medical waste materials. The transportation of APHIS-regulated plant and animal waste appears medical waste, as that term is defined in the HMR, the plant and animal waste is to meet the intent of this exception. While these materials are not regulated considered medical waste and is 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, APHIS-regulated plant and animal wastes are generated from laboratories and health care facilities and, thus, may be considered laboratory products for the purposes of the exception. I hope this information is helpful. Please accept my apology for any confusion our earlier response may have caused. Sincerely, Susan Gorsky Office of Hazardous Materials Standards Regulations Officer#

Page 4Edmonson $172.101 $172.2034GX2) November 30, 2006 Applicabiri47, Shippingtapers dical Waste Ms. Hattie L. Mitchell 06 - 0277 Chief, Regulatory Review and Reinvention U.S. Department of Transportation Office of Hazardous Materials Standards 400 Seventh Street, SW Pipeline and Hazardous Materials Safety Administration Washington, DC 20590-0001 Dear Ms. Mitchell: Institute (MWI) on October 12, 2006. As discussed at the Thank you for meeting with the Medical Waste Institute neeting, there are a number of issues for which MW nembers need clarification or a change in the PHMSA's description of each of these issues. Hazardous Materials Regulations (HMR). Below is a Package Markings and Labels 1. Interpretation on the Sequence of Information on nor proposed rules require a sequence of information on package markings and labels. equirement such that members have a letter in the fil he MWI requests a written interpretation of thi should a question arise during an inspection and for business planning purposes. 4301 Connecticut Ave.. NW 2. Technical Name for Regulated Medical Waste Suite 300 In the regulations under 49 CFR 171.101 (b)(4) when the letter G appears in the symbol column in the Washington. DC 20008 hazardous materials table a technical name must be included in parentheses after the proper shipping name 202-364-3724 phone on package labeling and shipping papers. The letter G 202-364-3792 fax appears in this column for "Regulated medical waste .o.s." However, there is not a technical rame fo difficult. regulated medical waste, which makes compliance#

Page 5MWI Letter/November 30, 2006/Page 2 of 3 technical name problem. The issue is whether the proposed rule will be finalized in this In proposed rule HM-215I, the G no longer appears in the table, which would fix the Tormat and in a timely fashion. Therefore, MWI requests that the PHMSA finalize HM- 215l before October 2007 in the manner proposed (no technical name requirement). If this is not possible, MWI requests that the PHMSA's enforcement office offer relief to the regulated comrunity until rule finalization. 3. "Dual Substances" and Dedicated Carrier Exception basis that were not fully considered by the PHMSA in the regulations. These include There are a number of materials that medical waste transporters collect on a regular "dual substances" where the regulated medical waste component cannot be separated contaminated chemotherapeutic wastes listed as a hazardous waste by the U.S rom the other components that usually are other hazardous materials, i.e. Environmental Protection Agency and also a regulated medical waste by the PHMSA. included in the same vehicle as regulated medical waste, n.o.s. and still allow the Under the current rules, a package holding these dual substances could not be transporter to take advantage of the dedicated/exclusive vehicle exception. packaging exception. The MWI is asking the PHMSA to extent the dedicated/exclusive carrier exception to allow for transport of these dual substances. MWI asserts that there is not a change or 4. APHIS Waste ard Dedicated Carrier Exception The U.S. Department of Agriculture's Plant and Animal Health Inspection Service PHMSA's regulated medical waste. included in the same vehicle as regulated medical waste, n.o.s. and still allow the Under the current HMSA rules, a package holding these APHIS wastes could not be transporter to take advantage of the dedicated/exclusive vehicle exception.#

Page 6MWI Letter/November 30, 2006/Page 3 of 3 Department of Agriculture. In this situation, MWI is only asking that the dedicated The HMR includes an separate exception for other materials managed by the U.S. carrier exception apply to these APHIS wastes rather than a separate exception such that knowledgeable people will still be handling these materials at the same level of risk as already considered in the HMR. As discussed at our meeting, there are a number of different ways procedurally these or, if a letter of interpretation was possible, that this letter would serve as a sufficient issues may be addressed. We agreed that this letter would either serve as a first step request. If additional information is required, please contact me at 202-364-3724 or alicej@envasns.org. Thank you. Sincerely, Alice P. fantash Alice P. Jacobsohn Director, Medical Waste Institute National Solid Wastes Management Association cC: Ed Mazullo, PHMSA MWI Members Eileen Edmonson, PHMSA#