{"operation":"document","citation":"00-0128","title":"Sure-Way Systems, Inc. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2000-10-18","effective_on":null,"summary":"00-0128 response to Sure-Way Systems, Inc. concerning 173.134.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-00-0128.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-00-0128.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-00-0128","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2000/000128.pdf","body":"<<<PAGE 1>>>\n\n.S. Departmer\n400 Seventh St., S.W.\nresearch and\nf Transportation\nWashington, D.C. 20590\nOCT 1 8 2000\nMr. Gary Chilcott\nRef. No. 00-0128\nCEO/President\nSure-Way Systems, Inc.\n310 East Harry Bridges Boulevard\nWilmington, CA 90744\nDear Mr. Chilcott:\nThis is in response to your letter and telephone conversations with members of this office\nconcerning whether your company's reusable sharps container conforms to the packaging\nrequirements for the transport of a regulated medical waste (RMW) under the Hazardous\nMaterials Regulations (49 CFR Parts 171-180).\nYou described the sharps container as a rigid, oblong, high-density polyethylene container with\nabsorbent foam at the bottom and a locking lid. Planges extending from the edge of the container\nhd are designed to be attached to, and suspended from, a metal cart rack. When offered for\ntransportation, the top, bottom and sides of the cart rack holding the containers are surrounded\nwith 1/8-inch thick polyethylene sheeting. The ends of the cart rack, where the containers are\nloaded and unloaded, are locked during transportation. You enclosed test reports that state the\nsharps container meets the Occupational Safety and Health Administration (OSHA) requirements\nin 29 CFR 1910.1030, and certain other performance criteria. Also, you enclosed several\nphotographs of the containers, which appear to be marked with the OSHA \"BIOHAZARD\"\nmarking, and the cart racks.\nBased on the information you submitted, it is our opinion that the polyethylene container meets\nthe criteria in $$ 171.8, 173.24, and 173.24a for a non-bulk, non-specification package. Under\n§ 173.134(b)(3), the container may be used for RMW (i.e., Regulated medical waste, 6.2, UN\n3291, PG II) that does not contain a waste culture or stock provided it is transported by private or\ncontract carrier. Each container must be marked in conformance with the proper shipping name,\nidentification number, etc., as required in 49 CFR Part 172, Subpart D, and with the ÖSHA\n\"BIOHAZARD\" marking. If the markings on the containers are not visible through the\n173134\n000128\n\n<<<PAGE 2>>>\n\npolyethylene sheeting, the sheeting must be marked according to the requirements for an\noverpack, as prescribed in § 173.25.\nI hope this satisfies your request.\nSincerely,\nHotte z. michels\nHattie L. Mitchell\nChief, Regulatory Review and Reinvention\nOffice of Hazardous Materials Standards\n\n<<<PAGE 3>>>\n\ncamorisu .\nSWS\n§173.134\n00 - 0128\nSure-Way Systems, Inc.\nApril 16, 2000\nEdward Mazzullo, Director\nOffice of Hazardous Waste Materials Standards\n400 Seventh St. S.W.\nU.S. D.O.T.\nWashington, D.C.\n20590\nDear Mr. Mazzullo,\nWe talked at the National medical waste conference in October about the need for secondary containment\nof our reusable sharps containers while they are being transported in transport cart racks during shipment\nad any continer\nto and from the hospital. You had indicated that you thought they did not need to be in certified\nsecondary containment enclosure given the fact we had gone through the D.O.T. testing.\nI would like to formally request a letter from your office clarifying the transportation of our FDA cleared\nsharps containers in our proprietary custom transport (Picture Attached). Our transport carts are specially\nconstructed to insure that the containers are upright and do not rub against each other except at the flange\nedge of the container. This design best protects the container form any damage while in route to and from\nthe hospital and treatment facility. These carts are also used to transport the containers around the\nhospital when the empty containers are exchanged with the filled containers.\nWhen the sharps containers are placed in the cart at the hospital, they are each locked with pins which\nrequire a special tool for their removal. Independent testing was done on the containers by 2 different\ncompanies testing the containers for puncture resistance, ability to hold liquids, drop tests for breakage,\nand a vibration test was done to simulate 5 years of typical transportation operation usage. Th\ncontainers that we have are approximately twice as thick as the disposable ones that they are replacing\nWe are enclosing a picture of the naked transport rack so the you can see how the containers ride in the\nransport cart. The carts that we will be using are just like the one in the picture, except they will have 1/\nnch thick polypropylene sheeting on the top, sides, and bottom. The ends of the transport cart, where the\ncontainers are loaded and unloaded, are locked during transport to secure the load.\nWe are attaching the independent test results as will as a picture of the unsheeted cart. Anything that you\n- Hey chI.\nHan Chilcot\nSure-Way Systems, Inc.\nProcessing plants Butte, MT Valley Cily, ND. Wilmington, CA 800-822-3929","truncated":false,"body_characters":4805}