{"operation":"document","citation":"99-0311","title":"Dornoch Medical Systems, Inc. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2000-05-15","effective_on":null,"summary":"99-0311 response to Dornoch Medical Systems, Inc. concerning 173.134.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-99-0311.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-99-0311.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-99-0311","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/1999/990311.pdf","body":"<<<PAGE 1>>>\n\nf Transportation\nS. Departmen\nResearch and\nSpecial Programs\nAdministration\nMAY 15 2000\n• Mr. James L. Dunn\nRef. No. 99-0311\nVice President Product Development\nDomoch Medical Systems, Inc.\n4032 Riverside Street\nRiverside, MO 64150\nDear Mr. Dunn:\nThis is in response to your November 18, 1999 and March 6, 2000 letters requesting clarification on\nrequirements for shipping regulated medical waste (RMW) under the Hazardous Materials Regulations\n(HMR; 49 CFR Parts 171-180), and the use of a product you referred to as a \"solidifier.\"\nYou state the purpose of this solidifying product is to take a liquid-filled suction canister that may have\nlarge blood clots and gel the solution into a less liquid state. The end result is more like a gelatin than a\nfree flowing liquid. The blood and body fluids would be considered potentially infectious, requiring the\ncontainer to be disposed of as infectious waste. You also state that these solidifiers do not always stay\nin the gelled state, and that warm temperatures often re-liquify the material.\nIt is your understanding that RMW with free flowing liquids may not be placed in roll-off or bulk\npackaging. Your understanding is correct. Bulk packagings are not authorized for the transportation of\nRMW except under the terms of an exemption. Section 173.134(c)(2) requires that a RMW be\npackaged as prescribed in § 173.197 in non-bulk specification packagings meeting the Packing Group\nIl performance level. In addition, you state that you have several questions regarding the shipment of\nthese waste products. Your questions are paraphrased and answered as follows:\nQ1. Have hospitals or the manufacturers of the solidifier product requested or received an exemption\nfor the use of this product to allow the liquids to be placed into roll-off or bulk packaging containers for\ntransportation of the RMW. If so, could I get a copy of the exemption?\nA1. We have not received any applications for exemptions from hospitals or manufacturers of the\nsolidifiers to use solidifiers for this purpose.\nQ2. Does the Department of Transportation (DOT) ask for testing results or work off the honor\nsystem?\nA2. If a manufacturer applies for an exemption, we will require the submission of laboratory data and\ntest results as part of the exemption application review process.\n173,134\n990311\n\n<<<PAGE 2>>>\n\n•\nQ3. Does the DOT consider blood clots a liquid that would have to be handled accordingly?\nA3. A material meets the defining criteria for a liquid in § 171.8 of the HMR if its initial melting point is\n20°C (68° F) or lower at 101.3 kpa (14.7 psi). In addition, a viscous material for which a specific\nmelting point cannot be determined must be subjected to the procedures specified in ASTM D 4359\n\"Standard Test Method for Determining Whether a Material is Liquid or Solid.\"\nQ4. Does the DOT consider a gelled liquid that can return to a liquid state a liquid or a solid?\nA4. If a hazardous material meets the definition of a solid under § 171.8 when packaged and offered\nfor transportation, it is a solid material under the HMR. However, the tests referred to in § 171.8 for\ndetermining whether a material is a liquid are performed at ambient temperatures. If a solid hazardous\nmaterial will likely encounter temperatures in transportation that may cause the material to become a\nliquid, § 173.24(e)(5) requires that the packaging be capable of containing the hazardous material in the\nliquid state. In addition, § 173.134(c)(2) requires that RMW be packaged as prescribed in § 173.197\nin a non-bulk specification packaging meeting the Packing Group Il performance level. Section\n173.197 also requires that the packagings be rigid, leak resistant, impervious to moisture, of sufficient\nstrength to prevent tearing or bursting under normal conditions of use and handling, scaled to prevent\nleakage during transport, puncture resistant for sharps, and break resistant and tightly lidded or\nstoppered for fluids in quantities greater than 20 cubic centimeters.\nQ5. What does the DOT recommend for the management of liquid RMW in the hospital setting?\nAS. DOT does not regulate the management of RMW in a hospital setting. We regulate the\ntransportation of RMW in commerce.\nQ6. Is the use of the product solidifier a way to get around the DOT regulations for free flowing\nliquids?\nA6. See response in A4.\nQ7. Since the U.S. Environmental Protection Agency (EPA) has determined that the solidifying\nproduct known as \"Premicide\" does not treat blood clots in suction canisters and should not be used in\nthis manner, should the transportation of these suction canisters with blood clots fall under the DOT's\njurisdiction and not be transported as treated waste?\nA7. Yes. A blood clot treated with chemical disinfectant, such as that contained in Premicide, that still\nmeets the hazard of an infectious substance does not qualify for exception from the HMR as treated\nmaterial. See § 173.134(b)(iv).\nQ8. What would be the associated fines for the transportation of untreated blood and body fluids from\nthe DOT?\n\n<<<PAGE 3>>>\n\nA8. The associated fines will depend on the violation. Appendix A to Subpart D of Part 107,\n\"Guidelines for Civil Penalties and List of Frequently Cited Violations,\" provide general guidance for\nmaking initial decisions for civil penalties in enforcement cases.\nI hope this answers your inquiry.\nSincerely,\non tell\nDelmer F. Billings\nChief, Standards Development\nOffice of Hazardous Materials Standards\n\n<<<PAGE 4>>>\n\nBoothe\n$173.134\nAssociate Administrator for Hazardous Materials Safety.\nResearch and Special Programs Administration\n11/18/99\n00 7' Street SV\nJ.S. Department of Transportatio:\n20590-0001\nWashington DC\n99-0311\nRoute DHM-10\nATTENTION: Department of Interpretation\nLiquid Infectious Waste Exeruption HE 10821\nDOT Exemption for Bulk Packaging and restriction of frce flowing liquids\nBy Phil Olsen\nDear Mr. / Ms.,\nspecific product used on the market today in the hospital setting. They have referred me to you. The generic\nI spoke to Jeff Fetner, Regulatory Specialist and Ann Mazzuilo, and Phil Olsen from the DOT about a\nliquid filled suction canister that may have large blood clots and gel the solution into a less liquid state. The\nname for this product is \"solidifier\". The name itself is a misnomer. The purpose of this product is to take a\npotentially infectious requiring the container to be placed in the infectious waste stream.\nend result is more like a gelatin vs. frec flowing liquid The blood and body fluids would be considered\nliquids require special handling and can not be placed in roll off or bulk packaging. I have several questions\nThe understanding I have for the DOT regulation of infectious waste handling requires that free flowing\ncontainers to be placed into non specialized infectious waste containers. Solidifiers do not always stay in\nin regards to the use of \"solidifiers\" and if the use of these types of products would justify the liquid\nperformance of the product. The use of this product is found in approximately 30% of the hospitals.(2000)\nthe gelled state. Warm temperatures will often re-liquefy the gel. The amount of solidifier used impacts the\nThe average hospital uses approximately 12,000 1/2 gallon canisters a year. This is a significant amount of\nTuid that is being transported from hospitals.\nI) Have hospitals or the manufacturers of the solidifier product requested or reocived an exemption for\nMy questions:\nthe use of this product to allow the liquids to be placed into roll off or bulk packaging containers for\ntransportation of the infectious waste. If so, could i get a copy of the exemption?\n2)\nHave the manufactures provided the DOT with the necessary laboratory data that proves that the\ngelled fluids would not return to a liquid state in warmer climates such as hospital storage areas or\nwaste trucks? Does the DOT ask for testing results or work off the honor system?\n3)\nDoes the DOT consider blood clots a liquid that would have to be handled accordingly.\n4)\nDoes the DOT consider a gelled liquid that can return to a liquid state a liquid or a solid?\n5)\n6) Is the use of the product \"solidifier\" a way to get around the DOT regulations of free liquids?\nWhat does the DOT recommend for the management of liquid infectious waste in the hospital setting?\nI appreciate your attention and response to these issues.\nThank You.\nJames L. Dunn Riv\nVice President\nProduct Development\nDoroch Medical Systems, Inc.\n4b32 Riverside Street\nRiverside, MO 441570","truncated":false,"body_characters":8493}