{"operation":"document","citation":"02-0098","title":"CB Healthcare Consulting — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2003-03-03","effective_on":null,"summary":"02-0098 response to CB Healthcare Consulting concerning 173.134.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-02-0098.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-02-0098.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-02-0098","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2002/020098.pdf","body":"<<<PAGE 1>>>\n\nof Transportation\nU.S. Department\n400 Seventh St., S.W.\nWashington, D.C. 20590\nSpecial Programs\nResearch and\nMAR 3\n2003\nAdministration\nPresident\nCaryn M. Bing, Rph, MS, FASHP\nReference No. 02-0098\nCB Healthcare Consulting\n12 Pine Tree Lane\nBurr Ridge, IL 60527\nDear Ms. Bing:\nThis is in response to your letter and telephone conversation with Eileen Edmonson of my staff\nconcerning the applicability of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-\n180) to a commercial home health care provider who removes \"Regulated medical waste\n(RMW), 6.2, UN 3291, PG II\" from a private home for return to the provider's facility for\nsubsequent disposal. We apologize for the delay in responding and any inconvenience this may\nhave caused. Your questions are paraphrased and answered below.\nQ1. Are there any provisions that except commercial home health care providers from any or\nall of the requirements in the HMR for transporting regulated medical waste?\nA1.\nWe revised the HMR requirements for transporting RMW in a recent final rule (Docket\nNo. RSPA-98-3971 (HM-226), copy enclosed). Under revised § 173.6, RMW and other\nDivision 6.2 (infectious substance) materials, other than Risk Group 4, may be excepted\nfrom certain requirements as materials of trade (MOTs) when transported by a private\ncarrier in direct support of a principal business that may not be transportation of goods by\nmotor vehicle. The MOTs exception provides for RMW that is generated through home\nprovider.\ntreatment of medical conditions and is transported elsewhere for disposal by the medical\nculture or stock to be transported by a private or contract carrier in a non-bulk, non-\nspecification packaging that satisfies the requirements in §§ 173.24 and 173.24a of the\nHMR and the Occupational Safety and Health Administration's (OSHA's) regulations in\n29 CFR 1910.1030. Each container must be marked with the OSHA \"BIOHAZARD\"\nmarking and with the proper shipping name, identification number, and additional\nQ2a.\nIs a sealed sharps container an authorized hazardous materials package under the HMR or\nmust it be placed in another type of packaging to be acceptable in transportation?\n113\n020098\n\n<<<PAGE 2>>>\n\nA2a.\nRevised § 173.6(a)(4) prescribes the use of a combination packaging. Specifically, this\nand leaks to be used as an inner packaging. The sharps container must be placed in an\nsection permits a sharps container constructed of a rigid material resistant to punctures\nduring transportation. Revised § 173.197(b) permits sharps and sharps with residual fluid\nin a single or combination, non-bulk, puncture-resistant packaging that meets the\nrequirements in 49 CFR Part 178, Subpart M, at the Packing Group II performance level.\nQ20. What type of outer packaging must the home health care provider use to transport\nreceptacles (e.g., sharps containers) containing RMW? Are there requirements for this\npackaging under the HMR?\nA2b.\nRMW sharps may be transported in packagings that meet the requirements in revised\n§ 173.6, 173.134, 173.196 or § 173.197, as applicable. Sections 173.6(a)(4)(ii) and\n173.196(a) require RMW to be placed in a combination packaging. Sections\n173.134(c)(1) and (c)(2), and 173.197(b) require RMW to be placed in a single or\ncombination packaging depending on the packaging's design type and performance and\nwhether or not a combination packaging is required under 29 CFR 1910.1030.\nQ2c.\nAre there non-bulk packagings available for purchase today marked to show they are\n\"DOT approved\" for transporting RMW?\nA2c.\nA packaging that meets the requirements in revised § 173.197(b) is a non-bulk packaging\nthat conforms to a UN standard at the Packing Group II performance level and is required\nto be marked with a UN standard marking as prescribed in 49 CFR Part 178, Subpart L.\nSee for example § 178.503. A infectious substance packaging that meets revised\n§ 173.196 is a non-bulk packaging that is required to be marked as prescribed in\n§ 178.503(f). A packaging that meets the exceptions in revised § 173.6 or § 173.134 is a\nnon-bulk, non-specification packaging.\nQ2d.\nMust a \"mail-back\" packaging that meets U.S. Postal Service requirements for\ntransporting RMW also meet RMW packaging requirements under the HMR? That is, a\nby the home health provider to his or her organization's designated place of business.\nmail-back package containing RMW sealed in the patient's home would be transported\nA2d.\nYes, a mail-back package containing RMW transported by a commercial home health\ncare provider is subject to the HMR and must meet applicable requirements.\nQ3.\nWhat type of documentation (e.g., a manifest or shipping paper) is required for home\nhealth care providers transporting RMW?\nA3.\nUnless excepted from the shipping paper requirements under the MOT exceptions or the\nterms of a DOT exemption or approval, RMW in commercial transportation must be\n2\n\n<<<PAGE 3>>>\n\n•\naccompanied by a shipping paper prepared in accordance with 49 CFR Part 172, Subpart\nshipping paper may be a shipping order, bill of lading, manifest or other shipping\nC. The HIMR do not specify a particular format for shipping papers. Under § 171.8, a\ndocument serving a similar purpose.\nQ4a.\npatient's home?\nWhat training must a home health care provider receive to transport RMW from a\nAta.\nThe home health care provider must receive hazmat training as prescribed in 49 CFR Part\n172, Subpart H. Since the employee packages and transports RMW, the employee must\neceive function-specific training to ensure the employee is knowledgeable in those area:\nnd can determine that a shipment is in compliance with the requirements of the HMF\nThe employee must also receive general awareness and safety training. See\n§ 172.704(a)(1) and (a)(3).\nQ4b.\nDoes the DOT have any training resources available that outline the function-specific\ntraining required for this limited scope of transporting RMW?\nA4b.\nWe offer courses and workshops on transporting infectious substances, including RMW,\nthat may assist with function-specific training (pamphlets enclosed). However, the\nhazmat employee's job tasks may include equipment and materials that might not be\ndiscussed. The hazmat employer is responsible for ensuring each hazmat employee's\nperform their individual job function. This training may be provided by the hazmat\ntraining is sufficient to provide the employee with the knowledge, skills, and abilities to\nemployer or other public or private sources, such as outside training firms or consultants,\nFederal or State agencies, colleges and universities, or any other organization offering\ntraining that meets the objectives.\nQ4c.\nWhat are the timing requirements for training an employee transporting RMW under\nthese type of conditions?\nA4c.\nSection 172.704(c)(1) requires that a new hazmat employee or a hazmat employee who\nchanges job functions must complete their hazmat training within 90 days after\nQ4d. How often must hazmat training be repeated?\n3\n\n<<<PAGE 4>>>\n\n•\nA4d.\nA hazmat employee must receive the required training at least once every three years.\nQ4e.\nWhat type of record keeping is required for hazmat training? How long must these\nrecords be kept?\nA4e.\nSection 172.704(d) requires that a record of current training, inclusive of the past three\nyears, be kept by each hazmat employer for each hazmat employee while that employee is\nemployed as a hazmat employee and for 90 days thereafter. This means each hazmat\nrom the previous three-year training cycle. It is not necessary to retain records of\nemployer is required to retain the most current training records and the training record:\nremedial instruction, discussed in our response under A4c, that is provided for new or\nrevised requirements until the next scheduled retraining at or within the three-year cycle.\nQ5.\nAre there additional regulations on the transportation of RMW under the HMR that have\nnot be identified in this inquiry?\nAS.\nThe answer is yes, but they are too numerous to discuss in this response. The HMR\nExceptions apply to some of the transportation scenarios discussed in your inquiry, but\nI hope this satisfies your request.\nSincerely,\ntitle z mithell\nHattie L. Mitchell, Chief\nRegulatory Review & Reinvention\nOffice of Hazardous Materials Standards\nEnclosures\n\n<<<PAGE 5>>>\n\nEdmonson\n§173.134\nCB Healthcare Consulting\n12 Pine Tree Lane\nRegulated Medical\nBurr Ridge, IL 60527\nWaste\n02-0098\nJune 6, 2002\nEdward T. Mazzullo\nDirector, Office of Hazardous Material Standards\nUS Department of Transportation/RSPA (DHM-10)\n400 Seventh Street, S.W.\nWashington, DC 20590-0001\nRE: Clarification of Document No 00-0295\nDear Mr. Mazzullo:\nIn the above referenced letter to Ms. Alice Jacobsohn, Esq. dated September 26, 2001,\nhome health care provider removes regulated medical waste (RMW) from a private\nyou clarified that the 'household' exemption to 49 CFR § 173.134(b) does not apply if a\nhome for disposal elsewhere. I would like to be sure that I understand the implications\nof the applicability Hazardous Materials Regulations (HMR) to commercial home care\nproviders, many of whom have historically needed only a limited background in DOT\nand HMR regulations. My interest relates to the transportation of materials that can be\nclassified as RIVW which are removed from the premises by a commercial home care\nprovider, not to waste that may be generated by an individual in a private residence and\ntreated as household waste exempted from HMR.\nI have included specific questions in the attached outline. If there are additional issues\nthat you would like to clarify related to DOT and HMR applicability to commercial home\nmatter.\ncare providers, that would also be appreciated. Thank you for your assistance in this\nSincerely,\nCary a Bing\nPresident\nCaryn M. Bing, RPh, MS, FASHP\n630-789-1771\nCB Healthcare Consulting\ncarynbing@earthlink.net\nattachment\n\n<<<PAGE 6>>>\n\nAttachment to June 6, 2002 letter to Mr. Edward Mazzullo, Director, Office of\nHazardous Materials Substances, US Department of Transportation\nQuestions regarding applicability of Hazardous Materials Regulations\n(HMR) regarding Regulated Medical Waste (RMW) to home health care\nproviders:\n1.\nQuantity of RMW:\nIs there an quantity (volume or weight) of RMW below which HMR might\nregarding transporting RMW (such as when a home care nurse carries a\nexempt a commercial home care provider from any or all of the regulations\nsmall sharps container from a patient's home back to the agency for\nappropriate holding and subsequent disposal according to HMR?)\nPackaging Requirements for Transporting RMW:\nIs a sealed sharps container sufficient to meet HMR, or does the provider\nneed to use a special type of packaging to hold these receptacles during\ntransport?\nIf required, what type of outer packaging must a home care provider use\nto transport receptacles (i.e. sharps containers) containing RMW (are\nthere specifications for these in the HMR?)\nAre there specific types of packaging available on the market today that\nare noted as 'DOT approved' for these purposes?\nIf a home care provider uses a 'mail back' system that meets US Postal\nServices requirements for shipping RMW, would the proper use of this\npackaging meet HMR (i.e. sealed in the home prior to transporting to the\nhome care provider organization's designated place of business?)\n3.\nDocumentation:\nWhat type of documentation (e.g. manifest/shipping paper) is required for\nthe transportation of RMW generated and transported under these\nconditions?\n06/06/02\nPage 2 of 3\n\n<<<PAGE 7>>>\n\nAttachment to June 6, 2002 letter to Mr. Edward Mazzullo, Director, Office of\nHazardous Materials Substances, US Department of Transportation\n4.\nTraining Requirements for Commercial Home Health Care Providers:\npersonnel who transport RMW from patient homes?\nWhat specific HazMat training is required for home care provider\nDoes the DOT have any specific resources available that outline the\nfunction-specific training required for this limited scope transporting of\nRMW?\ntraining for transporting RMW under these types of conditions?\nWhat are the HMR requirements regarding the timing of any special\nHow often must special training that meets HMR be repeated?\nWhat type of record keeping is required for training, and how long must\nthese records be retained.\nAdditional requirements or issues:\nAre there any additional issues in the HMR related to this type of RMW\nthat have not been identified in this inquiry?\n06/06/02\nPage 3 of 3","truncated":false,"body_characters":12429}