{"operation":"document","citation":"99-0298","title":"Micro-Med Industries, Inc. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"1999-12-13","effective_on":null,"summary":"99-0298 response to Micro-Med Industries, Inc. concerning 173.134.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-99-0298.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-99-0298.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-99-0298","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/1999/990298.pdf","body":"<<<PAGE 1>>>\n\n:\nof Transportation\nU.S. Department\nWashington, D.C.\n400 Seventh Street, S.W.\n20590\nResearch and\nSpecial Programs\nAdministration\nDEC 1 3 1999\nMr. Charles N. Hendrix\nRef. No. 99-0298\nVice President\nMicro-Med Industries, Inc.\n5169 West 12\" Street\nJacksonville, FL 32254\nDear Mr. Hendrix:\nThis responds to your letter, dated October 22, 1999, addressed to Mr. Bill Stevens in the\nResearch and Special Programs Administration's Southern Region Office of Hazardous\nMaterials Enforcement. Your letter addresses inconsistent federal and state regulatory\nrequirements for the transportation of regulated medical wastes.\nYou are correct that there appear to be some significant differences between the federal\ntransportation requirements applicable to regulated medical wastes in the Hazardous Materials\nRegulations (HMR; 49 CFR Parts 171-180) and requirements in effect in various states. The\nfederal hazardous material transportation law (49 U.S.C. 5101 et seq.) preempts many state and\nlocal laws and regulations concerning hazardous materials transportation that are not the same as\nthe federal requirements. (The enclosed index explains that preemption in detail.) Thus, where\nstate requirements do not meet the preemption standards in the law, they are superseded by the\nHMR.\nYour specific questions concerning transportation requirements for regulated medical wastes are\nparaphrased and answered below.\nQ1:\nCan a physician, clinic, or large facility offer for transport an untreated throat culture that\nis contaminated with the Streptococcus bacterium? Must the contaminated throat culture\nbe packaged according to UN or Packing Group II guidelines? If UN or Packing\nGroup II packaging is required, is it then acceptable for a solid waste garbage truck to\nreceive and compact the package, thereby destroying its integrity during transport to its\nfinal destination at a transfer station or landfill? Are shipping papers required?\nA1:\nCultures and stocks of infectious substances are considered hazardous materials under the\nHMR. Thus, a physician, clinic, or facility may offer an untreated throat culture\ncontaminated with the Streptococcus bacterium for transportation if the shipment meets\nall applicable HMR requirements. For example, under § 173.134(b)(4), a waste culture\nor stock of an infectious substance may be offered for transportation and transported as\nregulated medical waste under the following conditions: (1) the waste culture or stock\nmust conform to Biosafety Level 1, 2, or 3 as defined by the Centers for Disease Control\n(see HHS Publication 93-8395); (2) the waste culture or stock must be packaged in\n113.134\n990298\n\n<<<PAGE 2>>>\n\n2\npackagings conforming to the Packing Group II performance level as specified in Part\n178 of the HMR and to the requirements in § 173.197; and (3) the waste culture or stock\nmust be transported by a private or contract carrier using a vehicle dedicated to the\ntransportation of medical waste. Waste cultures and stocks that do not conform to the\nconditions listed in § 173.134(b)(4) must be transported in packagings that conform to the\nrequirements of § 173.196.\nNo person may offer for transportation or transport a waste culture or stock of an\ninfectious substance unless the material is handled and transported in accordance with\napplicable requirements in the HMR, including those applicable to shipping papers,\npackage marking and labeling, emergency response information, and employee training.\nIn addition, the shipment must also conform to the general packaging requirements in\nSubpart B of Part 173. With specific reference to your question, § 173.24 requires that\neach package used for the shipment of hazardous materials must be designed,\nconstructed, maintained, filled, and closed so that, under conditions normally incident to\ntransportation, the package will retain its integrity and its contents.\n02:\nCan a physician, clinic, or large facility offer for transport blood-contaminated untreated\nsyringes or needles in containers that do not meet UN or Packing Group II guidelines? If\nUN or Packing Group II packaging is required, is it then acceptable for a solid waste\ngarbage truck to receive and compact the package, thereby destroying its integrity during\ntransport to its final destination at a transfer station or landfill? Are shipping papers\nrequired for transport of contaminated syringes?\nA2:\nA syringe or needle contaminated with an infectious substance is considered regulated\nmedical waste under the HMR. Regulated medical waste must be packaged in\npackagings conforming to the requirements of Part 178 of the HMR at the Packing\nGroup II performance level. In addition, the packagings must be rigid, leak-resistant,\nimpervious to moisture, of sufficient strength to prevent tearing or bursting under normal\nconditions of use and handling; sealed to prevent leakage during transport; puncture-\nresistant for sharps; and break-resistant and tightly lidded or stoppered for fluids in\nquantities greater than 20 cubic centimeters (see § 173.197). Section 173.134(b)(3) of the\nHMR provides a packaging exception for a regulated medical waste that is transported by\na private or contract carrier. In such cases, the regulated medical waste may be packaged\nin a rigid, non-bulk packaging that conforms to the general packaging requirements in\n§§ 173.24 and 173.24a and the packaging requirements specified in regulations\npromulgated by the Occupational Safety and Health Administration (OSHA) at\n29 CFR 1910.1030.\nNo person may offer for transportation or transport a regulated medical waste unless the\nmaterial is handled and transported in accordance with applicable requirements in the\nHMR, including those applicable to shipping papers, package marking and labeling,\nemergency response information, and employee training. In addition, the shipment must\nalso conform to the general packaging requirements in Subpart B of Part 173. With\nspecific reference to your question, § 173.24 requires that each package used for the\nshipment of hazardous materials must be designed, constructed, maintained, filled, and\n\n<<<PAGE 3>>>\n\n3\nclosed so that, under conditions normally incident to transportation, the package will\nretain its integrity and its contents.\n03:\nWhat is DOT's definition of an \"infectious substance\"? Does the subjective judgement of\nthe individual determining \"infectious\" require consideration of OSHA's \"universal\nprecautions\"? Is untreated discarded blood an infectious substance?\nA3:\nFor purposes of the HMR, an infectious substance is a viable microorganism or its toxin\nthat causes or may cause disease in humans or animals. The term includes those agents\nlisted in regulations of the Centers for Disease Control (see 42 CFR 72.3) and any other\nagent that causes or may cause severe, disabling, or fatal disease. Untreated discarded\nblood that is contaminated with an infectious substance is considered a regulated medical\nwaste under the HMR. The HMR do not incorporate the \"universal precaution\" standards\nthat are the basis of OSHA's regulations concerning the handling of bloodborne\npathogens in laboratories and other work environments (see 29 CFR 1910.1030).\n04:\nAre all offerors of regulated medical waste required to comply with DOT regulations?\nDo these regulations apply to both small and large facilities?\nA4:\nNo person may offer for transportation or transport a regulated medical waste unless the\nshipment conforms to the requirements of the HMR. The HMR apply irrespective of\nwhether the offeror is a large or small facility. Further, the HMR apply to all shipments\nof regulated medical waste, even those shipments transported wholly within a single\nstate.\nYou may know that we are considering revisions to the current requirements in the HMR\napplicable to infectious substances, including regulated medical wastes. On September 2, 1998,\nwe published an advance notice of proposed rulemaking (ANPRM) in the Federal Register\nrequesting comment on: (1) whether the HMR should incorporate international standards for\ntransporting infectious substances, (2) possible revisions to the current exceptions in the HMR\nfor diagnostic specimens and biological products, and (3) additional packaging options for\ntransporting regulated medical wastes. We expect to issue a notice of proposed rulemaking on\nthese issues in the next year. A copy of the ANPRM is enclosed.\nI hope this information is helpful. If you have further questions, please do not hesitate to contact\nthis office.\nSincerely,\nShand I, gula\nDirector, Office of Hazardous Materials Standards\nEnclosures\n\n<<<PAGE 4>>>\n\nMicro-Med *\n8123k4/\nIndustries, Inc.\nMedical Waste Services\n99-0298\n5169 West 12th Street, Jacksonville, Florida 32254 • Telephone 904/693-3254 = FAX 904/693-3352\nOctober 22, 1999\nMr. Bill Stevens, Hazmat. Enforcement Specialist\nUnited States Department of Transportation\nResearch and Special Programs Administration\nOffice of Hazardous Materials Enforcement\nP.O. Box 20636\nAtlanta, GA 30320\nDear Mr. Stevens,\nMy company transports regulated medical waste including cultures and stocks of\ninfectious substances in five southeastern states. As you know, most states\nhave\nregulations concerning regulated medical waste packaging\nand\ntransportation.\nWe have attempted to educate our customers explaining their\nresponsibility as \"offerers\" of regulated medical waste (RMW) to comply with both\nfederal and state regulations. In discussions with customers from various states\nthough, there is unquestionably a significant difference between individual state\nregulations and those of DOT outlined in 49 CFR. Specifically, North Carolina,\nGeorgia and Tennessee regulators refer to their regulations as the governing\nbaseline requirement.\nIt seems that some explanation for the differences between state requirements\ncan be attributed to interpretation of federal OSHA requirements. It seems also,\nthat though federal DOT regulations have been in place for some time, a\ncombination of general interpretation through many years coupled with lack of\ncommunication and lack of enforcement probably played a part in the disparity of\neach state's ultimate regulations. North Carolina firmly believes that their\ndeveloped regulations\naddress\nan acceptable level and was confirmed\nacceptable by OSHA.\nFurthermore, \"offerers\" in these states often call the state agency and receive\nconfirmation that the state regulations are the governing requirement. Hence our\nconfusion as to where the communication between federal and state agencies\nlies to establish a standard. Likewise, we are sure this same conflict applies\nelsewhere and any official record DOT statement as to minimum requirements\nwould suffice in most instances.\n\"Safety, Service and Savings\"\nPrinted on 100% Recycled Paper\n\n<<<PAGE 5>>>\n\nFor example, North Carolina DEHNR rules (copy enclosed) allow the disposal of\ncontaminated syringes, sharps and other items, including blood in quantities less\nthan 20 cc's, bloody gauze, tubing and dressings to be disposed of as solid\nwaste (reference NCDEHNR reg's 1202(b), .1202(c), 1201(9). Thousands of\npounds of regulated medical waste, including thousands of untreated syringes,\nare transported daily to landfills in North Carolina in apparent violation of federal\nlaw. This daily occurrence is a direct contradiction of the intent of all medical\nwaste regulations as this is completely unregulated in both treatment and\ntransportation aspects.\nWithout outlining each states regulations, we might pose these direct questions\nfor DOT to provide clarification which can be used to educate state officials and\n\"offerers\" of regulated medical waste in these states:\n1. Can a physician, clinic or large facility offer for transport an untreated throat\nculture that is contaminated with the Streptococcus bacterium (thousands of\npositive \"strep\" cultures are generated by pediatric offices annually)? Must\nthe contaminated throat culture be packaged according to UN or packaging\nif UN or packaging group I! packaging is required, is it then acceptable for a\ngroup II guidelines?\nsolid waste garbage truck to receive and compact thereby destroying the\nintegrity of the package while in transport to its final destination at a transfer\nstation or landfill?\nAre shipping papers required?\n2. Can a physician, clinic or large facility offer for transport blood contaminated\nuntreated syringes or needles in non-UN or packaging group I approved\nIf UN or packaging group I approved containers are required, is it then\ncontainers?\nacceptable for a solid waste garbage truck to receive and compact thereby\ndestroying the integrity of the package while in transport to its final\ndestination at a transfer station or landfill?\nAre shipping papers required for transport of contaminated syringes?\n3. Given the DOT definition of \"regulated medical waste\", what is the DOT's\nDoes the subjective judgement of the individual determining \"infectious\"\ndefinition of an \"infectious substance\"?\nrequire consideration of OSHA's \"universal precautions\"?\nUnder DOT's definition, is untreated discarded blood an\n\"infectious\nsubstance\"?\n4. Are all offerers of regulated medical waste required to comply with DOT\nregulations? Do these regulations apply to both small and large facilities?\n\n<<<PAGE 6>>>\n\nWe applaud DOT's efforts to help clean up the industry and standardize\ncompliance. Further, we appreciate DOT taking compliance enforcement to the\ngenerators as offerers of regulated medical waste and infectious substances.\nWe would note however, that a mutual consideration be afforded as we work\ntogether to educate and inform the healthcare industry of these directives. It is\nobvious that all parties involved in the process have been operating at\nsignificantly different levels of interpretation and compliance for years.\nAs the senior enforcement specialist in our southeast region, we appreciate your\nefforts to meet and discuss these requirements. CFR regulations are not so\nblack and white when applied in the field. We believe that a coordinated\nschedule of meetings with state regulators open to haulers and generators is\nvery helpful.\nWith published notice, this would provide some structure to the\ntraining and information while affording maximum participation.\nThank you for answers or a referral of these questions to clarify this information.\nA prompt response to these issues is certainly in the interest of minimizing risk to\nthe general public and many downstream garbage workers. Thank you for your\nhelp and I look forward to your reply.\nCathet\nCC:\nMr. Edward Mazzullo\nMs. Eileen Edmonson Mack\nMr. Todd Clark\nMs. Edith Coulter\nMs. Alice Jacobson, Esquire","truncated":false,"body_characters":14632}