{"operation":"document","citation":"02-0021","title":"Sharps Compliance — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2002-01-30","effective_on":null,"summary":"02-0021 response to Sharps Compliance concerning 173.197.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-02-0021.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-02-0021.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-02-0021","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2002/020021.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nJAN 30 2002\nof Transportation\n400 Seventh St., S.W.\nWashington, D.C. 20590\nResearch and\npecial Program\ndministratio\nEdward Krisiunas, MT(ASCP), CIC, MPH\nSharps Compliance\nRef. No. 02-0021\n9050 Kirby Drive\nHouston, TX 77054\nDear Mr. Krisiunas:\nThis responds to your request during a Navember 28, 2001 telephone conversation with\nMs. Eileen Edmonson of my staff for written confirmation of a response you received from her\nby electronic mail on November 13, 2001. You asked whether an unmarked sharps-disposal-by-\nmail combination packaging, approved for use by the U.S. Postal Service (USPS) under\nauthorization no. 035J, fulfills the requirements for a sharps regulated medical waste packaging\nprescribed in § 173.197 of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180).\nYou also enclosed in an October 19, 2001 electronic mail message a copy of pages C-19 through\nC-36 of the USPS Domestic Mail Manual Issue 56 plus Postal Bulletin changes through PB\n22060 (10-4-01) that require a sharps packaging approved for use by the USPS to conform to the\nfollowing packaging performance tests in the HMR: §§ 178.604 (leakproof), 178.606 (stacking),\n178.608 (vibration), and 178.609 (infectious substance packaging). On November 8, 2001, you\nsupplied this office with an example of the packaging, a rigid 4.8-quart polyethylene bottle inside\na polyethylene bag inside a fiberboard box, but did not provide its performance test results.\nUN symbol on the packaging is responsible for ensuring that the packaging meets the UN\nUnder §$ 178.2 and 178.3, the manufacturer identified on a packaging or the person placing the\nstandard to which it is certified. However, based on the information you provided, it is the\nopinion of this office that the sharps combination packaging you described would conform to\n§§ 173.197 and 178.609 provided it successfully passes all prescribed performance tests for these\npackagings in 49 CFR Part 178 and these results are documented and maintained, as required in\n§ 178.601(l). Further, the packaging that complies with § 173.197 must be marked, as required\nin 49 CFR Part 178, Subpart L, with the symbols representing its design specification.\nI hope this satisfies your request.\nSincerely,\nTransportation Regulations Specialist\nOffice of Hazardous Materials Standards\n113.197\n\n<<<PAGE 2>>>\n\nма':\nPage 1 of 1\nEdmonson, Eileen\nNox 28\nFrom: EKrisiunas@aol.com\nSent:\nTuesday, November 20, 2001 5:20 PM\nEdmonson\nTo:\neileen.edmonson@rspa.dot.gov\nСс:\nBkunik@sharpsinc.com; cneal@sharpsinc.com\n$/73.197\nSubject: Correspondence on mailbacks\nRegulated Medical Waste\nDear Eileen:\n02-0021\nI would first like to thank you for your assistance during the past few weeks relative to the HMR and the\nmailback containers used by Sharps Compliance. Your agency has been one of the few that is always\nresponsive to questions and inquiries pertaining to its regulations.\nPer our discussions over the past few weeks, am I correct in the following summarization on the topic of\nmailbacks and the HMR:\nGiven that the USPS testing, standards found in the Domestic Mail Manual (DMM) are equivalent to DOT\nstandards, in regard to authorization required, packaging stardards and parameters, package documentation,\neduplaie sinalized manifest system with generators' certification and emergency response system, the\nmarkingtand labeling and package testing including periodic re-testing with documentation as well as a\nUSDOT acknowledges a USPS permitted regulated medical waste sharps by mail system as meeting the HMR\nstattdards in 49 CFR parts 171 - 180.\nPlease reply whether I am correct or if I have missed something. I can provide a hard copy of this letter via fax\nor Fed-Ex. If would be beneficial to receive your correspondence in writing as we will share it with our clients\nas part of our educational outreach on HMR with them.\nSincere regards,\nSharps Compliance\nEdward Krisiunas, MT(ASP), CIC, MPH\n9050 Kirby Drive\nHouston, Texas\n77054\nand\n115 Lyons Road\nBurlington, Connecticut\n06013\n860-675-1217\n860-675-1311(fax)\n12/28/01","truncated":false,"body_characters":4076}