{"operation":"document","citation":"16-0044","title":"Hall, Render, Killiam, Heath & Lyman, PC — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2016-09-06","effective_on":null,"summary":"16-0044 response to Hall, Render, Killiam, Heath & Lyman, PC concerning 173.134, 173.197, 173.199, 173.24, 173.24a, 173.6.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-16-0044.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-16-0044.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-16-0044","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2016/160044.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nof Transportation\nWashington, D.C. 20590\n1200 New Jersey Avenue, SE\nPipeline and Hazardous\nAdministration\nMaterials Safety\nSEP 0 6 2016\nAmy Berenbaum Goodman\nAttorney\nHall, Render, Killian, Heath & Lyman, P.C.\nWriter Square\n1512 Larimer Street, Suite 300\nDenver, CO 80202\nReference No. 16-0044\nDear Ms. Berenbaum Goodman:\nThis letter is in response to both your February 8, 2016, email and your April 6, 2016,\ntelephone conversation with a member of my staff requesting clarification of the Hazardous\nMaterials Regulations (HMR; 49 CFR Parts 171-180). Specifically, you ask how the HMR\ninfectious substance.\napply to the transportation by motor vehicle of soiled linen contaminated with a Division 6.2\nThe HMR define an infectious substance as a material known or reasonably expected to\ncontain a pathogenic microorganism or other agent, such as a proteinaceous infectious\nparticle (prion), that can cause disease in humans or animals (see § 173.134(a)(1)). A person\nwho offers, causes to be transported, or transports an infectious substance must comply with\nthe HMR requirements regarding packaging, hazard communication, training, and security\n(see 49 CFR Part 172, Subparts C through I). Additional requirements may apply, depending\non the mode of transportation (e.g., 49 CFR Part 177 applies to transportation by public\nhighway).\nA person who offers an infectious substance for transportation must (1) classify the material\naccording to its inherent risks and (2) assign it to either Category A or Category B based on\nthe known medical history or symptoms of the source patient or animal, endemic local\nconditions, or professional judgment concerning the individual circumstances of the source\nhuman or animal. A Category A infectious substance is in a form capable of causing\npermanent disability or life-threatening or fatal disease in otherwise healthy humans or\nanimals upon exposure (see § 173.134(a)(1)(i)). A Category B infectious substance is not in\n(see § 173.134(a)(1)(ii)).\na form generally capable of causing permanent disability or life-threatening or fatal disease\nfollowing:\nSoiled linen or laundry containing an infectious substance may be transported as one of the\n• Materials of Trade (MOT; § 173.6);\n\n<<<PAGE 2>>>\n\n• Laundry and medical equipment (§ 173.134(b)(12));\n• \"UN 3373, Biological substance, Category B, 6.2\" (Category B; § 173.199);\n• \"UN 3291, Regulated medical waste, n.o.s., 6.2, PG II\" (RMW; § 173.197); or\n• Materials known or suspected of being contaminated with the Ebola virus (Category\nA) using Department of Transportation Special Permit (DOT-SP) 16279.\nI have described each of these packaging methods as they apply to Division 6.2 contaminated\nlaundry below.\nMaterials of Trade\nLaundry contaminated with a Division 6.2, Category B material may be transported and\ndescribed as a MOT when it meets the definition of MOT in § 171.8, complies with the\nrequirements prescribed in § 173.6, and is transported by a private carrier in direct support of\na principal business, which may not be the transportation of goods by motor vehicle.\nDivision 6.2 materials that comply with the requirements prescribed in § 173.6 are not\nsubject to any other requirements of the HMR. Division 6.2 MOT must be placed in a\ncombination packaging where the inner packaging is leakproof for liquids and both rigid and\npuncture resistant for sharps. Additional packaging provisions in § 173.6(a)(4) apply.\nLaundry and medical equipment\nLaundry and medical equipment contaminated with a Division 6.2 material that conforms to\nthe bloodborne pathogen requirements prescribed in 29 CFR 1910.1030 of the Department of\nLabor, Occupational Safety and Health Administration, are not subject to the HMR as\nDivision 6.2 materials. This exception includes medical equipment intended for use,\ncleaning, or refurbishment (e.g., reusable surgical equipment, or equipment used for testing\napply to medical equipment being transported for disposal.\nwhere the outer components essentially function as packaging). This exception does not\nBiological substance, Category B\nSection 173.199 requires a Category B infectious substance to be packaged in triple\npackaging that is designed, constructed, and maintained so that under conditions normally\nencountered in transportation there will be no release of the hazardous material into the\nenvironment. The packages must also be capable of passing the drop tests in § 178.609(d), in\naccordance with § 173.199(a)(4). While the package must be capable of meeting these\nrequirements, it does not require testing and is not subject to the design qualification testing,\nperiodic retesting, or record retention (i.e., test report requirements) in § 178.601. Laundry\ncontaminated with a Division 6.2, Category B material that is transported for disposal or\nrecycling may also be described and packaged as a RMW.\nRegulated medical waste\nSection 173.197(b) permits sharps and sharps with residual fluid in a single or combination,\nnon-bulk, puncture-resistant packaging that meets the requirements in 49 CFR Part 178,\nSubpart M, at the Packing Group II performance level. Paragraphs (c) and (d) of § 173.197\n2\n\n<<<PAGE 3>>>\n\npermit RMW in UN standard Large Packagings, non-specification bulk packagings (i.e.,\nwheeled carts (Carts)), and bulk outer packagings (BOPs), respectively. Paragraph (e) of\n§ 173.197 prescribes what inner packagings may be used in Large Packagings, Carts, and\nBOPs. Section 173.134(c)(1)(ii) states RMW must not be transported on the same vehicle\nwith materials that contain a Division 6.2 waste stock or culture. However,\n§ 173.134(c)(2)(i) permits waste cultures and stocks of a Category B infectious substance to\nbe placed on board the same vehicle with RMW and other materials listed in this section\nprovided the RMW is offered for transportation and transported as RMW; packaged in a rigid\nnon-bulk packaging conforming to the general packaging requirements of §§173.24 and\n173.24a and packaging requirements specified in 29 CFR 1910.1030; and transported by a\nprivate or contract carrier in a vehicle used exclusively to transport regulated medical waste.\nEbola virus (Category A) using DOT-SP 16279\nDOT-SP 16279 authorizes approved parties permission to transport for disposal materials\ncontaminated with or suspected of being contaminated with the Ebola virus, which is a\nCategory A infectious substance. The special permit prescribes packaging and handling\nrequirements for non-bulk and bulk combination packagings transported by motor vehicle\nand cargo vessel. If the materials to be transported are too large to use the packaging system\ndescribed in paragraph 7.b.(1) of DOT-SP 16279, the special permit requires that the\nmaterials be placed in larger article packagings prescribed in paragraph 7.b.(2) and that the\nofferor notify the Pipeline and Hazardous Materials Safety Administration that this\npackaging method is to be used.\nAlso, please note soiled linen or laundry that meets the definition of another hazard class or\nthat is a hazardous substance, hazardous waste, or marine pollutant, must be offered for\ntransportation and transported in accordance with the applicable requirements of the HMR.\nI hope this information is helpful. Please contact us if we can be of further assistance.\nSincerely,\nTAlenn\nFasten\nT. Glenn Foster\nChief, Regulatory Review and Reinvention Branch\nStandard and Rulemaking Division\n\n<<<PAGE 4>>>\n\nINTERPRETATION LETTERS\nDate Received:\n3/17/2016\nRequester\nAmy Berenbaum Goodman\nTracking\n16-0044\nCompany\nHall, Render, Killian, Heath & Lyman, P.C.\nRevision Date:\n3/17/2016\nPhone\n303-802-1298\nDate Assigned\n3/17/2016\nDate of Letter\n3/16/2016\nStaff\nEdmonson\nFirst Draft Due:\n41712016\nSection\n173.134\nFirst Draft Date:\nSubject\nDefinitions\nConcurrence\nStatus\nStatus Date\n3/17/2016\nSign Date\nSignor\nHBP\nCopy to Docket\nCopy to DHM-60\nComment","truncated":false,"body_characters":7874}