{"operation":"document","citation":"00-0104","title":"EnviroTech of America, Inc. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2000-10-23","effective_on":null,"summary":"00-0104 response to EnviroTech of America, Inc. concerning 173.134.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-00-0104.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-00-0104.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-00-0104","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2000/000104.pdf","body":"<<<PAGE 1>>>\n\nof Transportation\nU.S. Department\n400 Seventh St., S.W.\nWashington, D.C. 20590\nResearch and\npecial Programs\ndministratior\nAUG 2\n2000\n•\nMr. Jeffrey A. Paiste\nReference No. 00-0104\nVice President, Enviro Tech of\nAmerica, Inc.\nP.O. Box 239\nEast Syracuse, New York 13057\nDear Mr. Paiste:\nThis is in response to your inquiry and telephone conversations with me and a member of my\nstaff concerning the marking of non-bulk packages that will be used to transport regulated\nmedical waste (RMW) that does not contain a culture or stock of an infectious substance. You\nasked if a packaging manufacturer is permitted to mark \"UN 3291, PG II\" on the outside of an\nempty, knocked-down fiberboard box that has not been performance tested without assuming\nliability for the marking or the packaging. You also stated the RMW shipments are transported\nby private or contract carrier.\nThe answer is yes. RMW that does not include cultures or stocks of an infectious substance,\nand is transported by a private or contract carrier is not required to be placed in a packaging\nmeeting the Packing Group II performance level. Section 173.134(b)(3) authorizes the use of\na non-specification packaging for such materials, if certain requirements are met. Based on the\ninformation you provided, your packaging satisfies these requirements.\nFurther, please note that the proper shipping name \"Regulated medical waste\" must also be\nmarked on a package containing RMW. See § 172.301.\nI hope this satisfies your request.\nSincerely,\nHallez, pittell\nHattie L. Mitchell, Chief\nRegulatory Review and Reinvention\nOffice of Hazardous Materials Standards\n173.134.\n000104\n\n<<<PAGE 2>>>\n\n798 Hartwell Avenue\nEast Syracuse, New York 13057\nP.O. Box 239\nEnviroTech of America, Inc.\nTelephone: (315) 463-7178\nFax: (315) 463-7134\nVia Facsimile\nmack\nMarch 28, 2000\n§173.134\nU.S. Department of Transportation\nAttn: Mr. Edward 1. Mazzulio, Director\n00 - 0104\nOffice of Hazardous Materials Standards\n400 Seventh Street, S. W.\nWashington, D.C. 20590\nFacsimile:\n1-202-366-3012\nSubject:\nRequest for Confirmation of Regulated Medical Waste Packaging and Labeling\nRequirements\nDear Mr. Mazzullo:\nThis letter is sent to your office to request written DOT confirmation of the standards which must be\nused for the transportation of regulated medical waste (RMW) in cases in which the 49 CFR 173.134\nmet in order to allow manufacturers to imprint the \"UN 3291 PG I\" identifier on outer packages to be\n(b)(3) exemption applies.\ncompliance with 6 NYCRR Part 364 requirements for packaging and transportation of RMW. As\nMy company is a commercial RMW transporter permitted by the State of New York, operating in\nsuch, we are able to employ the 49 CFR 173.134 (b)(3) exemption for contract carriers of RMW.\nTo the best of my knowledge, through compliance with 6 NYCRR Part 364 packaging requirements,\not cardboard or plastic and inner containments of plastic liner bags, sharps containers or fluid\ncontainers, sufficiently meet the applicable DOT and OSHA performance standards, in that they are\n1) Rigid;\n2) Leak-resistant;\nImpervious to moisture;\n4) Of sufficient strength to prevent tearing or bursting under normal conditions of use and\n5)\nSealed to prevent leakage during transport\nhandling\nPuncture resistant for sharps and sharps with residual fluids;\nBreak-resistant and tightly lidded or stoppered for fluids in quantities greater than 20 cubic\ncentimeters, and;\n8)\nLabeled with a biohazard symbol.\nEnviroTech does not rely on packaging manufacturers to supply complete systems of inner and outer\nurchase single-use outer cardboard boxes and reusable plastic outer bins, plastic liner bags, and\njackaging for transportation of regulated medical waste. Instead, as is the practice in our industry, we\nplastic sharps and fluid containers from numerous vendors. We then provide these packaging\n-\n\n<<<PAGE 3>>>\n\nMr. Edward T. Mazzullo, Director\nPage 2\nleak-proof packages suitable for safe transport of their RMW. (Of note, within New York State, this\ncomponents to our customers, the medical waste generators, who in turn assemble fully contained,\nassignment of medical waste packaging responsibility is dictated by the 6 NYCRR Part 364\nmedical waste packaging using the appropriate inner and outer containments.)\nregulations, which very clearly make the medical waste generator responsible for assembling the\nThe problem we are encountering is that the manufacturers of our outer cardboard and plastic\ncontainers do not believe that they are permitted to provide the \"UN 3291 PG I\" imprint on these\nouter containers without completion of performance testing of the complete packaging system, yet\nthey are unable to accomplish this performance testing because they do not control or sell the complete\npackaging system.\nI believe that much of the problem stems from conflicting direction between the 49 CFR 173.134\nand testing so long as the requireinents of 173.24 and 173.24a are met, and the section 173.24 (d)(1)\n(b)(3) exemption, which allows avoidance of Section 173.197 requirements and Part 178 specifications\nrequirement to perform Part 178 testing for UN specification packaging. If a UN identifier is required\nin cases for which the 49 CFR 173.134 (b)(3) exemption applies, then a clarifying statement from the\nneeded.\nDOT explaining how to resolve this apparent regulatory conflict on package testing is definitely\nMy understanding of the packaging and labeling requirements applicable when the 49 CFR 173.134\n(b)(3) exemption is in force is that manufacturers of our outer packages are authorized to produce these\nouter cardboard or plastic containers for EnviroTech's use imprinted with the \"UN 3291 PG I\"\nidentifier without having to conduct any Part 178 performance testing. It is also my understanding that\nEnviroTech and its medical waste customers, not the outer container manufacturers, bear responsibility\nfor assessment that each complete packaging system employed satisfactorily meets the general DOT\nand OSHA performance criteria enumerated above.\nI believe that a letter from the DOT confirming the correctness of our understanding of these particular\nI can be reached at either 610-366-0312 early most weeks or 315-463-7178 late most weeks if you'd\nlike more details on our regulated medical waste packaging concerns. Thanks.\nRespectfully,\nfatase\nreffrey A. Paiste\nVice President","truncated":false,"body_characters":6363}