{"operation":"document","citation":"03-0265","title":"The Daniels Corporation — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2003-11-14","effective_on":null,"summary":"03-0265 response to The Daniels Corporation concerning 173.197.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-03-0265.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-03-0265.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-03-0265","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2003/030265.pdf","body":"<<<PAGE 1>>>\n\nof Transportation\nU.S. Department\nNOV 14 2003\n400 Seventh St., S.W.\nSpecial Programs\nResearch and\nWashington, D.C. 20590\nAdministration\nMs. Terry Grimmond\nClinical Director\nRef. No.: 03-0265\nThe Daniels Corporation\n3 Tarbett Rd Hillorest\nHamilton 2001, New Zealand\nDear Ms. Grimmond:\nThis responds to your inquiry of October 20, 2003, regarding Regulated Medical Wastes\n(RMW) and labeling of sharps containers in accordance with the Hazardous Materials\nRegulations (HMR; 49 CFR Parts 171-180).\nYour company produces a reusable sharps container that has passed UN requirements for\ncertification as a primary transport container (although the sharps container is collected and\ncompany currently supplies hospitals in the United States with these containers, and it is your\ntransported from hospitals in a large, dedicated secondary container on wheels). Your\ninfectious substances. You ask about marking and labeling requirements for the sharps\nunderstanding that the United States has adopted the international requirements for shipping\ncontainers.\nWe recently revised the requirements in the HMR for infectious substances, including sharps\nmeeting the definition of RMW, to harmonize them with international standards and\nincorporate several RMW exemptions (67 FR 53118, August 14, 2002; Docket HM-226).\nCertain of these revised requirements refer to the Food and Drug Administration's (FDA)\nrequirements for sharps containers, and the FDA is the lead agency in approving single-use\nand reusable medical devices, such as sharps containers. The HMR do not supersede these\nrequirements. For more information on the FDA's requirements, you may wish to contact\nMis. Diane Goldsberry or Ms. Carolyn Niebauer of the FDA's Centers for Devices and\nRadiological Health, Office of Compliance, Division of Enforcement, General Hospital\nDevices Branch, HFZ-333, 2094 Gaither Road, Rockville, MD, 20850, at 301-594-4618.\nSharps containers used as inner packagings in bulk packagings used to transport RMW must\nwhen the entire contents of the bulk packaging originates at a single location and is delivered\nbe durably marked or tagged with the name and location (city and state) of the offeror, except\nto a single location (see § 173.197(e)). If intended for reuse, a sharps container must be\napproved by PDA as a medical device for reuse and must be permanently marked for reuse\nsee § 173.197(e)(3)). Sharps containers used as inner packagings in bulk packagings used to\ntransport RMW need not be labeled with a Division 6.2 (INFECTIOUS SUBSTANCES) labe\nor a BIOHAZARD label. However, the outer bulk packaging must be marked with a\nBIOHAZARD marking that conforms to the requirements in § 172.323 and with the UN\n030265\n173.197\n\n<<<PAGE 2>>>\n\nidentification number (UN 3291) in accordance with § 172.302.\nFor non-bulk shipments, a sharps container must be puncture-resistant for sharps and sharps\nwith residual fluids as demonstrated by conducting the performance tests in Subpart M of Part\n178 of the HMR. A sharps container that conforms to the DOT or UN performance\nrequirements must be marked as indicated in § 178.503(f). For shipments of sharps that meet\n3291\" and with the name and address of the consignor or consignee (see § 172.301(a) and\nthe definition for RMW, the sharps container must be marked \"Regulated Medical Waste, UN\n(d)). The container must be labeled with a Division 6.2 (infectious substances) label. Only\nshipping name. When transported by a private or contract carrier, RMW, including sharps, in\none label is required to be displayed on a non-bulk packaging in association with the proper\na non-bulk package is excepted from the requirement for a Division 6.2 label if it is marked\nwith a \"BIOHAZARD\" marking in accordance with regulations of the Occupational Safety\nand Health Administration at 29 CFR 1910.1030 (see § 173.134(c))).\nRMW\nA Division 6.1 (POISON) label is not authorized under the HMR for packages containing\nI hope this satisfies your inquiry. If we can be of further assistance, please contact us.\nSincerely,\nWhos thog\nSusan Gorsky\nOffice of Hazardous Materials Standards\nSenior Transportation Regulations Specialist\n\n<<<PAGE 3>>>\n\nMessage\nPage 1 of 2\nGorsky, Susan\nFrom:\nCushmac, George\nEngrum\nSent:\nMonday, October 20, 2003 8:03 AM\nTo:\nGorsky, Susan\n$113.191\nCc:\n'terry@daniels.com.au'; Cushmac, George\nSubject: FW: Labelling sharps containers\nRegulated Medical Waste\nSusan,\n03-0265\nregarding DOT requirements for the labelling of sharps containers (see e-mail message\nPer our conversation earlier this morning, I am forwarding a question from Terry Grimmond\nbelow). Please respond directly to Mr. Grimmond.\nThanks,\nGeorge\n----Original Message-....\nSent: Friday, October 17, 2003 4:48 PM\nFrom: Terry Grimmond [mailto:Terry@daniels.com.au]\nTo: Cushmac, George\nSubject: Labelling sharps containers\nDon Burger suggested 1 put my Q to you. I am enquiring re DOT requirements for the labelling of sharps\nDear Dr Cushmac,\ncontainers.\nMy company produces a reusable sharps container that has passed UN requirements for certification as a\nTDG requirements.\necondarv container on wheels. V\n\"UN 3291\" compulsory?)\nQ1. What must be shown on a sharps container label? (ie, is the UN biohazard diamond compulsory in USA; is\nshown on a sharps container label? (ie, is the UN biohazard diamond used in USA or should it be the skull 8\n22. For the use of reusable sharps containers for disposal of chemotherapeutic sharps waste, what must be\nCrossbones 6.1 diamond? Or both?).\nQ3. If diamonds are required, are they required on opposite sides of the container?\nI have read the DOT regs fairly thoroughly but cannot see where small container labelling is covered.\nKind regards,\nTerry Grimmond\nClinical Director, The Daniels Corporation\n3 Tarbett Rd Hillcrest, Hamilton 2001, New Zealand\nPh/Fx) +64 7 856 4042\nMob (NZ): +6125,365 140\n10/20/03","truncated":false,"body_characters":5869}