Sharps Compliance — Hazardous Materials Safety Interpretation

Page 1U.S. Department JAN 30 2002 of Transportation 400 Seventh St., S.W. Washington, D.C. 20590 Research and pecial Program dministratio Edward Krisiunas, MT(ASCP), CIC, MPH Sharps Compliance Ref. No. 02-0021 9050 Kirby Drive Houston, TX 77054 Dear Mr. Krisiunas: This responds to your request during a Navember 28, 2001 telephone conversation with Ms. Eileen Edmonson of my staff for written confirmation of a response you received from her by electronic mail on November 13, 2001. You asked whether an unmarked sharps-disposal-by- mail combination packaging, approved for use by the U.S. Postal Service (USPS) under authorization no. 035J, fulfills the requirements for a sharps regulated medical waste packaging prescribed in § 173.197 of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). You also enclosed in an October 19, 2001 electronic mail message a copy of pages C-19 through C-36 of the USPS Domestic Mail Manual Issue 56 plus Postal Bulletin changes through PB 22060 (10-4-01) that require a sharps packaging approved for use by the USPS to conform to the following packaging performance tests in the HMR: §§ 178.604 (leakproof), 178.606 (stacking), 178.608 (vibration), and 178.609 (infectious substance packaging). On November 8, 2001, you supplied this office with an example of the packaging, a rigid 4.8-quart polyethylene bottle inside a polyethylene bag inside a fiberboard box, but did not provide its performance test results. UN symbol on the packaging is responsible for ensuring that the packaging meets the UN Under §$ 178.2 and 178.3, the manufacturer identified on a packaging or the person placing the standard to which it is certified. However, based on the information you provided, it is the opinion of this office that the sharps combination packaging you described would conform to §§ 173.197 and 178.609 provided it successfully passes all prescribed performance tests for these packagings in 49 CFR Part 178 and these results are documented and maintained, as required in § 178.601(l). Further, the packaging that complies with § 173.197 must be marked, as required in 49 CFR Part 178, Subpart L, with the symbols representing its design specification. I hope this satisfies your request. Sincerely, Transportation Regulations Specialist Office of Hazardous Materials Standards 113.197#

Page 2ма': Page 1 of 1 Edmonson, Eileen Nox 28 From: EKrisiunas@aol.com Sent: Tuesday, November 20, 2001 5:20 PM Edmonson To: eileen.edmonson@rspa.dot.gov Сс: Bkunik@sharpsinc.com; cneal@sharpsinc.com $/73.197 Subject: Correspondence on mailbacks Regulated Medical Waste Dear Eileen: 02-0021 I would first like to thank you for your assistance during the past few weeks relative to the HMR and the mailback containers used by Sharps Compliance. Your agency has been one of the few that is always responsive to questions and inquiries pertaining to its regulations. Per our discussions over the past few weeks, am I correct in the following summarization on the topic of mailbacks and the HMR: Given that the USPS testing, standards found in the Domestic Mail Manual (DMM) are equivalent to DOT standards, in regard to authorization required, packaging stardards and parameters, package documentation, eduplaie sinalized manifest system with generators' certification and emergency response system, the markingtand labeling and package testing including periodic re-testing with documentation as well as a USDOT acknowledges a USPS permitted regulated medical waste sharps by mail system as meeting the HMR stattdards in 49 CFR parts 171 - 180. Please reply whether I am correct or if I have missed something. I can provide a hard copy of this letter via fax or Fed-Ex. If would be beneficial to receive your correspondence in writing as we will share it with our clients as part of our educational outreach on HMR with them. Sincere regards, Sharps Compliance Edward Krisiunas, MT(ASP), CIC, MPH 9050 Kirby Drive Houston, Texas 77054 and 115 Lyons Road Burlington, Connecticut 06013 860-675-1217 860-675-1311(fax) 12/28/01#