Hospitec — Hazardous Materials Safety Interpretation

Page 1U.S.Department of Transportation Washington, D C 400 Seventh Street, S.W. 20590 Research and Special Programs Administration NOV - 9 2000 Mr. Christopher Hahn Reference No. 00-0296 Vice-President, Sales Hospitec 285 Granada Road West Palm Beach, FL 33401 Dear Mr. Hahn: This is in response to your letters and conversations with members of my staff concerning the requirements for a regulated medical waste packaging under § 173.197 of the Hazardous Materials Regulations (49 CFR 171-180). Specifically, you asked if a plastic sharps container that is puncture-resistant, leakproof, and has passed requirements in 49 CFR Part 178 at the Packing Group II performance level is required to have a polyethylene liner (red bag). You state that the liner was shredded during each test. If the use of a plastic liner is not necessary to that packaging's performance, such as to satisfy the moisture or leak resistance criteria, there is no requirement under § 173.197 to use a liner. I hope this satisfies your request. Sincerely, Hathe R. Mittell Hattie L. Mitchell Chief, Regulatory Review and Reinvention Office of Hazardous Materials Standards#

Page 2Oct 13 D0 12:28p Christopher Hahn-Hospitec 561-833-9179 P.1 1à : t3m134 Reaulated Medical Hospitec ne. .. Beyond tills. Waste FAX 203 - 502 Bow Valley Trail Canmore Alberta Company: D.0.J- Canada TIW IN9 Tcl: 403-609-4330 5ax: 707-366-3012 Fax: 403-609-4337 Toll Free: 1-800-337-2885 Pages (Including Cover): 2 Email: office@hospitecinc.com COVER Date: 10/13/00 From: CHRIs HAnD Reference: QUESTION REGARDINO REGULATES IN ERROR OR THE INFORMATION IS UNCLEAR, PLEASE NOTIFY US IMMEDIATELY BY TELEPHONE. THIS FAX CONTAINS INFORMATION THAT IS PRIVILEGED AND CONFIDENTIAL IF YOU HAVE RECEIVED THS COMMUNICATION TAIL IS MY SULONA TINE RESUMMITINE TATE ATTACHES QUESTION. I GRIGINAL SUMMITTRO TAIS QUESTION TO FILEEN FEDMONSON ON JuLy 26, J000 AND sAua NoS RECEIVEs A RESPONSE BACK. WOULD yOU BE KINO FENDOGA TO GIUE ME A RESPONSE AS yOUR EARLIRST CONVENIENCE, IT IS IMPONTANT THAT I HAVa TAHS INFONMATTON AS SOON AS POSSIBLEE, SO I CAN PROVIDE SOMETHING IN UNITINE TO My CUSTUMERS TARE ARE REQUESDINA IT. DOT. BUT I NICO SOMETHINE AN § NOT NECESSANY, UNITING TO SAMSFY MY CUSTUMERS , TANK 400. BEST REGAROS, PAMIC#

Page 3Oct 13 00 12:28p Christopher Hahn-Hospitec 561-833-9179 p.2 Eamnonson 8 173.134 Hospitec Regulated Medical Waste October 13, 2000 Mr. Edward Mazzullo Director of Hazardous Materials Standard U.S. Department of Transportation Research and Special Programs Administration 400 Seventh St., S.W. DHM-10 Washington, DC 20590-0001 Dear Mr. Mazzullo: I would appreciate some clarification in writing regarding the testing protocol used for the testing (red bag) be placed inside a puncture-resistant, leak-proof plastic sharps container that has passed of Group Il Packaging of Regulated Medical Waste. Is it required that a polyethylene plastic liner the Packaging Group II Performance Standards? I would like to add, that when the festing of our containers was completed by Ten-E Packaging Services, it was reported to us that the plastic liners served no purposo, since the inside liner also informed by two D.O.T. Enforcement Specialists that the inner liner was not written into the would always fail, due to the fact, that it always shredded from the sharps material inside. I was protocol, and was not necessary. Unfortunately, I found this out after the testing was completed. Please send response to the following address: 285 Granada Road, W. Palm Beach, FL 33401. Thank you for your help. Sincerely, aDar Christopher Hahn Vice-President of Sales Innovations in Healthcare#