Scopelitis, Gavin, Light, Hanson & Feary, P.C. — Hazardous Materials Safety Interpretation

Page 1U.S. Department of Transportation Pipeline and Hazardous Materials Safety Administration August 22, 2023 1200 New Jersey Avenue, SE Washington, DC 20590 Mr. Timothy W. Wiseman Partner Scopelitis, Gavin, Light, Hanson & Feary, P.C. 10 West Market Street, Suite 1400 Indianapolis, IN 46204 Reference No. 22-0070 Dear Mr. Wiseman: This is in response to your July 14, 2022, letter requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to the transportation of used sharps. Specifically, you ask about a plastic film bag used as an inner packaging when transporting sharps in a Large Packaging. We have paraphrased and answered your questions as follows: Q1. In your letter, you note that § 173.197(e)(3) of the HMR specifies that sharps transported in a Large Packaging must be packaged in a puncture-resistant, non-bulk inner packaging (sharps container)—which in your opinion may be similar to the plastic film bag identified in § 173.197(e)(1) used to transport solid regulated medical waste. You ask whether the non-bulk inner packaging (sharps container) may be a plastic film bag provided it is puncture-resistant, and—when exceeding 20 gallons—capable of passing the performance test in Part 178, Subpart M at the Packing Group II performance level. A1. Paragraph (e)(1) of § 173.197 specifies the requirements for the inner packaging for solid regulated medical waste transported in a Large Packaging. Sharps are objects that can pierce certain types of packaging, therefore, the inner packaging for sharps transported in a Large Packaging must conform to § 173.197(e)(3). Each puncture-resistant, non-bulk inner packaging (sharps container) used to transport sharps in a Large Packaging must be securely closed to prevent leaks or punctures in conformance with instructions provided by the packaging manufacturer and each sharps container exceeding 76 L (20 gallons) in volume must be capable of passing the performance tests in part 178, subpart M at the Packing Group II performance level. A sharps container intended for reuse in a Large Packaging must be approved and certified as a medical device for reuse by the U.S. Food and Drug Administration (FDA) and meet additional requirements under § 173.197(e)(3). Please note, a sharps container may be subject to other requirements, such as The Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens standard (see 29 CFR § 1910.1030) and FDA and U.S. Environmental Protection Agency (EPA) requirements.#

Page 2Q2. You ask what specific performance test may be required under Part 178, Subpart M for the plastic film bag used as the inner packaging of a Large Packaging when transporting sharps. A2. PHMSA has not identified a testing procedure to determine whether a poly bag can resist punctures from hypodermic needles and other sharp objects generated in the medical industry. If you can identify a test standard that demonstrates puncture resistance of a poly bag to objects— such as used hypodermic needles— and provides for an appropriate level of safety for the transportation of hazardous materials, you may ask PHMSA to incorporate by reference a new standard by filing a petition for rulemaking in accordance with rulemaking procedures in §§ 106.95-106.105. I hope this information is helpful. Please contact us if we can be of further assistance. Sincerely, T. Glenn Foster Chief, Regulatory Review and Reinvention Branch Standards and Rulemaking Division#

Page 3Pollack 22-0070 From: Foster, Glenn (PHMSA) To: Date: Attachments: Dodd, Alice (PHMSA); Hillman, Kenetha CTR (PHMSA) Subject: FW: Request for Guidance Thursday, July 14, 2022 6:17:16 AM Foster - Request Interpretation 7-13-22.docx Good morning, Alice and Kenetha. Please have the attached checked in and assigned as a request for a letter of interpretation. Thanks, Glenn From: Wiseman, Tim <twiseman@scopelitis.com> Sent: Thursday, July 14, 2022 5:46 AM To: PHMSA_Guidance <PHMSA_Guidance@dot.gov> Cc: Foster, Glenn (PHMSA) <Glenn.Foster@dot.gov> Subject: Request for Guidance 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. Please find the attached Request for Guidance, and let me know if you have any questions. Thanks! -Tim Timothy W. Wiseman, Partner Scopelitis, Garvin, Light, Hanson & Feary, P.C. 10 West Market Street, Suite 1400, Indianapolis, IN 46204 twiseman@scopelitis.com | T: 317.637.1777 | D: 317.492.9221 CONFIDENTIALITY NOTICE: This message is privileged and confidential for the addressee(s) named above. If you are not the intended recipient, you are prohibited from disseminating, using, or copying the contents and should notify the sender immediately that you received this message in error. The signature(s) within this email does not constitute any binding agreement.#

Page 410 West Market Street Suite 1400 Indianapolis, IN 46204 TIMOTHY W. WISEMAN twiseman@scopelitis.com The full service transportation law firm www.scopelitis.com Main (317) 637-1777 Fax (317) 687-2414 August 23, 2023 Mr. T. Glenn Foster, Chief Regulatory Review & Reinvention Branch Standards & Rulemaking Division U.S. Department of Transportation Pipeline & Hazardous Material Safety Adm. 1200 New Jersey Avenue, SE Washington, DC 20590 Re: 49 C.F.R. § 173.197(e)(3) Request for Interpretation Dear Mr. Foster: Pursuant to 49 C.F.R. § 105.20, I write to request guidance with respect to the requirements for the transportation of sharps in a large packaging under 49 C.F.R. § 173.197(e)(3), which provides, in pertinent part, as follows: Sharps transported in a Large Packaging, Cart, or BOP must be packaged in a puncture-resistant inner packaging (sharps container). Each sharps container must be securely closed to prevent leaks or punctures in conformance with instructions provided by the packing manufacturer. Each sharps container exceeding 76 L (20 gallons) in volume must be capable of passing the performance test in Part 178, Subpart M, of this Subchapter at the Packing Group II performance level. Indianapolis ■ Chicago ■ Washington, D.C. ■ Los Angeles ■ Chattanooga Detroit ■ Dallas/Fort Worth ■ Milwaukee ■ Seattle ■ St. Louis ■ Cincinnati SERVICES OUTSIDE CALIFORNIA AND MICHIGAN PROVIDED BY SCOPELITIS, GARVIN, LIGHT, HANSON & FEARY, PROFESSIONAL CORPORATION SERVICES IN MICHIGAN PROVIDED BY SCOPELITIS, GARVIN, LIGHT, HANSON & FEARY, PROFESSIONAL LIMITED LIABILITY COMPANY SERVICES IN CALIFORNIA PROVIDED BY SCOPELITIS, GARVIN, LIGHT, HANSON & FEARY, LIMITED LIABILITY PARTNERSHIP#

Page 5Mr. T. Glenn Foster, Chief August 23, 2023 Page 2 My questions pertaining to the particular regulation are as follows: 1. Can the inner packaging referenced in § 173.197(e)(3) be a plastic film bag (similar to the film bag identified in § 173.197(e)(1)) as long as it is puncture-resistant, and, when exceeding 20 gallons, capable of passing the performance test in Part 178, Subpart M at the Packing Group II performance level? 2. If the response to Question #1 is yes, what specific performance test would be required under Part 178, Subpart M, for the plastic film bag used as the inner packaging with a large packing for the transportation of sharps? If any additional information is needed to consider this request, please do not hesitate to contact me. Very truly yours, /s/ Timothy W. Wiseman Timothy W. Wiseman TWW/kkc#