{"operation":"document","citation":"99-0124","title":"Arent Fox Kintner Plotkin Kahn, PLLC — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"1999-12-07","effective_on":null,"summary":"99-0124 response to Arent Fox Kintner Plotkin Kahn, PLLC concerning 173.134.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-99-0124.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-99-0124.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-99-0124","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/1999/990124.pdf","body":"<<<PAGE 1>>>\n\n...:-\nU.S.Department\n400 Seventh Streel, S.W.\nof Transportation\nNashington, D.C\n20590\nResearch and\nSpecial Programs\nAdministration\nDEC 7 1999\nMr. Paul Jackson Rice\nRef. No. 99-0124\nArent Fox Kintner Plotkin & Kahn, PLLC\n1050 Connecticut Avenue, N.W.\nWashington, D.C. 20036\nDear Mr. Rice:\nThis responds to your letters of May 10 and September 7, 1999, and telephone conversations\nwith Ms. Eileen Mack of my staff, concerning the transportation requirements applicable to\nused sharps under the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180).\nPlease accept my apology for our delay in answering your inquiries.\nSharps are objects that can penetrate the skin, such as needles, scalpels, broken glass, broken\ncapillary tubes, and exposed ends of dental wires. Used sharps that are not contaminated\nwith an infectious substance or any other material meeting one of the hazard classes defined\nin the regulations are not subject to the HIMR.\nFor purposes of the HMR, used sharps that are contaminated with an infectious substance\nare considered regulated medical waste, Division 6.2. Regulated medical waste is a waste or\nreusable material, other than a culture or stock of an infectious substance, that contains an\ninfectious substance and is generated in: (1) the diagnosis, treatment, or immunization of\nhuman beings or animals; (2) research pertaining to the diagnosis, treatment, or\nimmunization of human beings or animals; or (3) the production or testing of biological\nproducts. A package containing a regulated medical waste is subject to the HMR, whether\nor not that regulated medical waste is commingled with non-regulated waste. Regulated\nmedical waste must be packaged in packagings conforming to the requirements of Part 178\nof the HMR at the Packing Group II performance level. In addition, the packagings must be\nrigid, leak resistant, impervious to moisture, of sufficient strength to prevent tearing or\nbursting under normal conditions of use and handling; sealed to prevent leakage during\ntransport; puncture resistant for sharps; and break resistant and tightly lidded or stoppered\nfor fluids in quantities greater than 20 cubic centimeters (see § 173.197).\nThe HMR include several exceptions applicable to the transportation of regulated medical\nwaste. For example, a regulated medical waste that is transported by a private or contract\ncarrier is excepted from the requirement that it be labeled with an INFECTIOUS\nSUBSTANCE label provided that the outer packaging is marked with a BIOHAZARD\nmarking in accordance with the regulations of the Occupational Safety and Health\n173.184\n990124\n\n<<<PAGE 2>>>\n\n2\nAdministration (OSHA) governing bloodborne pathogens (29 CFR 1910.1030). A regulated\nmedical waste that is transported by a private or contract carrier is also excepted from the\nspecific packaging requirements of § 173.197 provided it is packaged in a rigid, non-bulk\npackaging that conforms to the general packaging requirements in §§ 173.24 and 173.24a\nand the packaging requirements specified in 29 CFR 1910.1030.\nMedical equipment that meets the definition of a Division 6.2 material and is prepared for\ntransportation in conformance with the OSHA requirements in 1910.1030(d)(2)(xiv) is not\nsubject to any of the requirements in the HMR (see § 173.134(b)(1)(iii). This OSHA\nprovision applies to equipment that has been decontaminated to the fullest extent practicable.\nThis exception was incorporated into the HMR in 1995 to relieve generators of regulated\nmedical waste from the burden of complying with both the HMR and the OSHA regulations.\nFor a discussion of the reasons for and applicability of this exception, see the preamble to\nthe final rule published September 20, 1995 (60 FR 48780). The exception applies to\nmedical equipment that is intended for reuse. The exception does not apply to medical\nequipment that is being transported for disposal. For purposes of this exception, medical\nequipment includes equipment used for diagnosis, research, or treatment, such as reusable\nsurgical equipment or equipment used for testing where the components within which the\nequipment is contained essentially function as packaging. Used sharps are not considered\nmedical equipment for purposes of this exception.\nI hope this information is helpful. If you have further questions, please do not hesitate to\ncontact this office.\nSincerely,\nElwar 7. Marg\nEdward T. Mazzullo\nDirector, Office of Hazardous Materials Standards\n\n<<<PAGE 3>>>\n\nIll Arent Fox\nATTORNEYS AT LAW\nPaul Jackson Rice\nArent Fox Kintner Plotkin & Kahn, PLLC\nDirect 202/857-6009\n1050 Connecticut Avenue, NW\nWashington, DC 20036-5339\nricepi@arentfox.com\nPhone 202/857-6000\nFax 202/857-6395\nwww.arentfox.com\nSeptember 7, 1999\nVIA FACSIMILE AND U.S. MAIL\nDirector, Office of Hazardous Materials Standards\nEdward Mazzullo\nResearch and Special Programs Administration\n400 7\" Street, S.W.\nWashington, D.C. 20590\nRE: Request for Regulatory Interpretation - 49 C.F.R. § 173.134\nDear Mr. Mazzullo:\nThis letter follows up on my May 10, 1999 letter that requested a regulatory interpretation of 49\nC.F.R. § 173.134 from the Research and Special Programs Administration (\"RSPA\"). The May\n10, 1999 letter (a copy of which is enclosed for your convenience) sought guidance with respect\nto the circumstances under which used medical instruments that are sharp, such as scalpels and\nneedles (hereinafter, \"used sharps\") are subject to the Hazardous Materials Regulations\n(\"HMR\"). As of today, we are not in receipt of any formal response from your office.\nWhile checking on the status of our request, we were put in contact with Ms. Eileen Mack, the\nconversation between Ms. Mack and Adam Cramer, one of my associates, Ms. Mack advised that\nRSPA technical writer assigned to handle the matter. During a June 29, 1999 telephone\nRSPA's response to our request was still in draft form, and that the draft response may still need\nto be reviewed by RSPA counsel. Ms. Mack explained that the regulation at issue, 49 C.F.R. §\n173.134, was complex and also contained certain references to Occupational Safety and Health\nAdministration (\"OSHA) regulations. Ms. Mack encouraged us to contact her again to check on\nthe status of the draft response.\nSubsequent to our June 29, 1999 phone conversation, we received a voice-mail message from\nMs. Mack advising us that because of the OSHA reference in 49 C.F.R. § 173.134, OSHA would\nbe in a better position to respond to our request for regulatory interpretation. Indeed, Ms. Mack\neven provided a name and telephone number of an individual at OSHA. While we do appreciate\nMs. Mack's efforts, we hesitate to rely on an OSHA interpretation of a RSPA regulation.\n1/\nSubsequent to Ms. Mack's voice-mail, we attempted, unsuccessfully, to contact her.\nWASHINGTON, DC\nNEW YORK\nRIYADH\nBUDAPEST\nBUCHAREST\n\n<<<PAGE 4>>>\n\nArent Fox\nEdward Mazzullo\nSeptember 7, 1999\nPage 2\nWe are particularly interested in a written response from your office given RSPA's long running\nand that RSPA, rather than OSHA, is the agency responsible for enforcing the HMR. Therefore,\npractice of helping the regulated community by providing written interpretations of the HMR,\nwe respectfully request that RSPA either provide the regulatory interpretation originally sought in\nthe May 10, 1999 letter, or advise us in writing that RSPA will defer to all aspects of OSHA's\ninterpretation of 49 C.F.R. § 173.134, whatever those interpretations may be.\nThis issue is of consequence to a client, and a prompt response would be greatly appreciated\nPlease contact me, or Adam Cramer (202/857-6414) if we can be of any assistance to you in this\nrequest.\nSincerely\nTau\nPaul Jackson Rice\ncc:\nAdam B. Cramer, Esq.\nEileen Mack\n\n<<<PAGE 5>>>\n\nМаск\nIll Arent Fox\n$173.134\nATTORNEYS AT LAW\nPaul Jackson Rice\n99-0124\nArent Fox Kintner Plotkin & Kahn, PLLC\nDirect 202/857-6009\nI050 Connecticut Avenue, NW\nWashington, DC 20036-5339\nricepi@arentfox.com\nPhone 202/857-6000\nFax 202/857-6395\nwww.arentfox.com\nMay 10,1999\nVIA FACSIMILE AND U.S. MAIL\nEdward Mazcullo\nDirector, Office of Hazardous Materials Standards\nResearch and Special Programs Administration\n400 7' Street, S.W.\nWashington, D.C. 20590\nRE: Request for Regulatory Interpretation - 49 C.F.R. § 173.134\nDear Mr. Mazcullo:\nThe purpose of this letter is to request a regulatory interpretation of 49 C.F.R. § 173.134 from the\nResearch and Special Programs Administration (\"RSPA\"). More specifically, we are interested\nin the circumstances under which used medical instruments that are sharp, such as scalpels and\nneedles (hereinafter, \"used sharps\") are subject to the Hazardous Materials Regulations\n(\"HMR\"). To further focus this request, we pose the following three questions:\n(1)\nAre used sharps that do not contain an infectious substance subject to the HMR?\n(2)\nAre used sharps that are believed to contain an infectious substance, but handled\nand transported consistently with the Occupational Safety and Health\nAdministration (\"OSHA\") regulations pertaining to blood-borne pathogens, 29\nC.F.R. § 1910.1030, exempt from the HMR?\n(3)\nIf used sharps that contain an infectious substance are commingled with other\nused sharps, and the aggregate collection of used sharps is handled and\ntransported consistently with 29 C.F.R. § 1910.1030, is this commingled\nOur reading of the HMR suggests that used sharps free from infectious substances are not subject\nto the HMR, and that if used sharps contain an infectious substance, such used sharps are exempt\nfrom the HMR to the extent they are handled and transported according to 29 C.F.R. §\n1910.1030. The analysis that supports our reading of the HMR follows.\nWASHINGTON, DC\nNEW YORK\nRIYADH\nBUDAPEST\nBUCHAREST\n\n<<<PAGE 6>>>\n\nArent Fox\nEdward Mazcullo\nMay 10, 1999\nPage 2\nRegulated Medical Waste\nThe HMRs define Regulated Medical Waste (\"RMW\") in pertinent part:\n(4) A regulated medical waste means a waste or reusable material ... that contains an\ninfectious substance and is generated in —\n(i) The diagnosis, treatment or immunization of human beings or animals.\"\nnot considered a hazardous material under the HMR.\nExceptions Under the HMR for Regulated Medical Waste\nAlthough used sharps that contain an infectious substance fit the HMR definition of RMW, there\nappear to be significant regulatory exceptions if the used sharp is handled and transported\naccording to certain OSHA regulations. Section 173.134(b) provides in pertinent part:\n(1) The following are not subject to any requirements of this subchapter if the items as\npackaged do not contain any material otherwise subject to the requirements of this\nsubchapter:\n...\n(ii) Laundry or medical equipment that conforms to 29 CFR 1910.1030 of the\nregulations of the Occupational Safety and Health Administration of the\nDepartment of Labor 3\nIt appears that a used sharp that contains an infectious substance, and thus is a RMW under the\nHMR, is nonetheless exempt from the HMR if handling and transportation of the used sharp\nconforms with OSHA regulations at 29 C.F.R. $ 1910.1030. Indeed, it seems that when\ntransporting used sharps that meet the definition of RMW, a regulated entity is effectively given\na \"choice\" to follow either the HMR or the OSHA regulations at 29 C.F.R. § 1910.1030.\n49 C.F.R. § 173.134(a)(4) (1998).\nInfectious substance is defined under the HMR at 49 C.F.R. § 173(a)(1) (1998).\n3/\n49 C.F.R. § 173.134(b)(1) (1998).\n\n<<<PAGE 7>>>\n\nArent Fox\nEdward Mazcullo\nMay 10, 1999\nPage 3\nThe exception at 49 C.F.R. § 173.134(b)(1) is conditioned on the requirement that materials\nbeing transported not contain any \"material otherwise subject to the requirements of this\nsubchapter.\" We interpret this condition as applying to circumstances where the RMW has some\nadditional attribute (other than containing an infectious substance) that makes it a hazardous\nmaterial under the HMR such as, ignitability or corrosivity. Indeed, reading the condition any\nother way would appear to make the entire exception in 49 C.F.R. § 173.134(b) superfluous.\nCommingling\nIf the transportation of used sharps that contain an infectious substance, regardless of OSHA\nsharps (some of which contain an infectious substance, some of which do not) would be treated,\ncompliance, is not excepted from the HMR, then it appears that a commingled package of used\nas far as the HMR are concerned, as RMW.\nConclusion\nIn short, it appears that used sharps that do not contain an infectious substance do not meet the\nHMR definition of a RMW, and thus are not subject to the HMR. Used sharps that contain an\ninfectious substance meet the definition of RMW, but if such used sharps are handled and\ntransported consistently with OSHA regulations regarding blood-borne pathogens, they are\nexcepted from the HMRs. Please advise whether our interpretation (and the reasoning\nunderlying the same) of 49 C.F.R. § 173.134 is accurate. İf our interpretation is incorrect, please\nexplain RSPA's interpretation of 49 C.F.R. § 173.134.\nPlease contact me, or Adam Cramer (202/857-6414) if we can be of any assistance to you in this\nrequest.\nSincerely,\nJait\nPaul Jackson Rice\ncc:\nAdam B. Cramer, Esq.","truncated":false,"body_characters":13123}