Clean Harbors — Hazardous Materials Safety Interpretation

Page 1U.S. Department of Transportation Pipeline and Hazardous Materials Safety Administration 1200 New Jersey Avenue, SE Washington, DC 20590 December 18, 2024 Mr. Paul Rheaume Clean Harbors 2130 E. Grauwyler Road Irving, TX 75061 Mr. Kent Bongarzone Cyn Environmental Services 100 Tosca Drive Stoughton, MA 02072 Reference No. 24-0049 Dear Messrs. Rheaume and Bongarzone: This letter is in response to your June 3, 2024, and June 11, 2024, letters requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to regulated medical waste (RMW). We have paraphrased and answered your questions as follows: Q1. In your June 11, 2024, letter you describe a scenario where urine cups are re-capped after laboratory testing is completed. The urine cups—containing liquid contents—are further placed in red bags with a single knot and then placed in 31-gallon RMW containers with folding clamshell lids. You ask whether the above-described packaging is in compliance with § 173.134(b)(12)(ii). A1. The answer is no, as the provisions in § 173.134(b)(12)(ii) apply to “used health care products”1 being returned to the manufacturer or the manufacturer’s designee. Patient specimens being transported for disposal do not meet this criterion. Q2. In your June 3, 2024, letter you describe a scenario where liquid bodily fluid contained in screw-top leak-resistant containers is classed as “UN3291, Medical waste, n.o.s., 6.2.” The containers are packaged in UN4H2 plastic boxes in accordance with § 173.197(b). You further state that the cups are braced or cushioned to prevent shifting or damage. You ask whether the above packaging scenario is authorized under § 173.197(b). 1 https://www.ecfr.gov/current/title-49/part-173/section-173.134#p-173.134(a)(8)#

Page 2A2. The answer is yes. Provided—as you describe in your letter—there are no sharps or foreign articles present, materials properly classed under “UN3291, Medical waste, n.o.s., 6.2” may be transported in UN standard packagings conforming to the requirements of part 178 of the HMR. I hope this information is helpful. Please contact us if we can be of further assistance. Sincerely, Alexander Wolcott Acting Chief, Regulatory Review and Reinvention Branch Standards and Rulemaking Division#

Page 3Pollack 24-0049 From: INFOCNTR (PHMSA) To: Dodd, Alice (PHMSA) Cc: Hazmat Interps Subject: FW: Regulations pertaining to liquid in Regulated Medical Waste Request for Answer and Interpretation Date: Friday, June 14, 2024 4:44:58 PM Attachments: Clarification Letter Liquid in RMW - Signed.pdf Hello Alice, Please see the attached interpretation request. Let me know if you need anything. -Breanna From: Rheaume, Paul <rheaume.paul@cleanharbors.com> Sent: Tuesday, June 11, 2024 6:54 PM To: INFOCNTR (PHMSA) <INFOCNTR.INFOCNTR@dot.gov> Subject: Regulations pertaining to liquid in Regulated Medical Waste Request for Answer and Interpretation CAUTION: This email originated from outside of the Department of Transportation (DOT). Do not click on links or open attachments unless you recognize the sender and know the content is safe. Good evening, Please see the attached request for regulatory guidance and interpretation. Thank you for your assistance, Paul Safety Starts With Me: Live It 3-6-5 ____________________________________________________________________________ ___ Paul Rheaume CLH Account Manager, Healthcare Services Clean Harbors South Region (C) 254-405-9530 Rheaume.Paul@CleanHarbors.com www.cleanharbors.com Upcoming PTO: from 7/4/2024 returning 7/16/2024#

Page 5Paul Rheaume Clean Harbors 2130 E. Grauwyler Road Irving, TX 75061 254-405-9530 June 11, 2024 U.S. Department of Transportation Pipeline and Hazardous Materials Safety Administration 1200 New Jersey Avenue, SE Washington, DC 20590 Via: Certified U.S. Mail and Email Re: Question Regarding Liquid Regulated Medical Waste Packaging Requirements Follow-up In a follow up to my previous email and Kent Bongarzone’s letter dated June 3, 2024, included. I would like to get the PHMSA’s guidance on the current practice of one of our accounts and an interpretation of 49 CFR 173.134(b)(12)(ii)(A). First, the current practice is to recap urine cups after testing and disposing of them into a red bagged lined 31 gallon regulated medical waste tub, with folding clamshell lids. Assuming the red bag is single knot tied or closed using a zip tie, is this practice compliant with applicable packaging standards and exemptions for medical waste transported on a dedicated hazardous material truck? Secondly, is the below regulation applicable to the urine cups mentioned in the previous question? 49 CFR 173.134(b)(12)(ii)(A) (A) Each used health care product must be drained of free liquid to the extent practicable and placed in a watertight primary container designed and constructed to assure that it remains intact under conditions normally incident to transportation. For a used health care product capable of cutting or penetrating skin or packaging material, the primary container must be capable of retaining the product without puncture of the packaging under normal conditions of transport. Each primary container must be marked with a BIOHAZARD marking conforming to 29 CFR 1910.1030(g)(1)(i). Thank you for your time and assistance in providing a written answer and interpretation. Sincerely, Paul Rheaume CLH Account Manager, Healthcare Clean Harbors Environmental Services “People and Technology Creating a Safer, Cleaner Environment”#

Page 6CleanHarbors® June 3, 2024 FROM: Kent Bongarzone Cyn Environmental Services 100 Tosca Drive Stoughton, MA 02072 TO: US Department of Transportation Pipeline and Hazardous Materials Safety Administration 1200 NEW JERSEY AVENUE, SE WASHINGTON, DC 20590 Via: Certified US Mail Re: Question Regarding Liquid Regulated Medical Waste Packaging Requirements. I hope this message finds you well. I would like to request clarification as to if I have a proper understanding of the packaging regulations applicable to Regulated Medical Waste (RMW) under 49CFR $173.197 Regulated medical waste. Paragraphs A, B & C are for reference. (A) Waste: A medical facility regularly generates containers of Regulated Medical Waste. The RMW consists of liquid bodily fluid placed into leak resistant non-rated plastic containers, smaller than 10 ounce capacity, closed with screw top lids, commonly referred to as Closed Cups. The are no sharps or foreign articles present. The proper USDOT shipping name has been determined by the shipper to be UN3291, MEDICAL WASTE, N.O.S., 6.2, PG II. (B) Packaging: A UN Rated plastic closed bin meeting the UN rating of UN4H2/430/S/23/USA/+AA6065 manufactured by Rehrig Medical Systems. Attached please find the UN/DOT Performance Testing Results for this container. This package UN rating specifies this container is as follows: a. 4= Box, b. H= Plastic, c. 2 = Removable top. d. Y = PG||. e. 30.7 = Gross mass rating in kg. f. S = Intended to contain solids only or inner packagings. g. 23 = year of manufacturer. h. USA = state of manufacture. i. Symbol of the manufacturer.#

Page 7ENVIRONMENTAl CleanHarbors (C) Regulation: §173.197 details the packaging requirements for RMW. For the material above, the regulations require the packaging must be rigid containers meeting the provisions of subpart B of part 173 (21-67), and be UN standard packagings conforming to the requirements of part 178 of this subchapter at the Packing Group II performance level. Question: Since the closed cups of RMW are inner packagings, would you agree that if all of the provisions of subpart B of part 173 (21-67) are met, including the inner packagings being braced or cushioned to prevent shifting or damage, that it would be acceptable to place the waste in (A) above into package (B) under regulation (C)? Please do not hesitate to contact me if you have any questions, concerns, or need more information provided. Thank you for your time and assistance, it is very much appreciated. Respectfully, Kent Baggare Kent Bongarzone Transportation Compliance Specialist Cyn Environmental Services / Clean Harbors Inc. Bongarzone.kenton@cleanharbors.com 781-664-8310 (cell) Attachment: Ten-E Test Report# 19-MN20298 / UN/DOT Performance Testing Results#