The Daniels Corporation — Hazardous Materials Safety Interpretation

Page 1of Transportation U.S. Department NOV 14 2003 400 Seventh St., S.W. Special Programs Research and Washington, D.C. 20590 Administration Ms. Terry Grimmond Clinical Director Ref. No.: 03-0265 The Daniels Corporation 3 Tarbett Rd Hillorest Hamilton 2001, New Zealand Dear Ms. Grimmond: This responds to your inquiry of October 20, 2003, regarding Regulated Medical Wastes (RMW) and labeling of sharps containers in accordance with the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). Your company produces a reusable sharps container that has passed UN requirements for certification as a primary transport container (although the sharps container is collected and company currently supplies hospitals in the United States with these containers, and it is your transported from hospitals in a large, dedicated secondary container on wheels). Your infectious substances. You ask about marking and labeling requirements for the sharps understanding that the United States has adopted the international requirements for shipping containers. We recently revised the requirements in the HMR for infectious substances, including sharps meeting the definition of RMW, to harmonize them with international standards and incorporate several RMW exemptions (67 FR 53118, August 14, 2002; Docket HM-226). Certain of these revised requirements refer to the Food and Drug Administration's (FDA) requirements for sharps containers, and the FDA is the lead agency in approving single-use and reusable medical devices, such as sharps containers. The HMR do not supersede these requirements. For more information on the FDA's requirements, you may wish to contact Mis. Diane Goldsberry or Ms. Carolyn Niebauer of the FDA's Centers for Devices and Radiological Health, Office of Compliance, Division of Enforcement, General Hospital Devices Branch, HFZ-333, 2094 Gaither Road, Rockville, MD, 20850, at 301-594-4618. Sharps containers used as inner packagings in bulk packagings used to transport RMW must when the entire contents of the bulk packaging originates at a single location and is delivered be durably marked or tagged with the name and location (city and state) of the offeror, except to a single location (see § 173.197(e)). If intended for reuse, a sharps container must be approved by PDA as a medical device for reuse and must be permanently marked for reuse see § 173.197(e)(3)). Sharps containers used as inner packagings in bulk packagings used to transport RMW need not be labeled with a Division 6.2 (INFECTIOUS SUBSTANCES) labe or a BIOHAZARD label. However, the outer bulk packaging must be marked with a BIOHAZARD marking that conforms to the requirements in § 172.323 and with the UN 030265 173.197#

Page 2identification number (UN 3291) in accordance with § 172.302. For non-bulk shipments, a sharps container must be puncture-resistant for sharps and sharps with residual fluids as demonstrated by conducting the performance tests in Subpart M of Part 178 of the HMR. A sharps container that conforms to the DOT or UN performance requirements must be marked as indicated in § 178.503(f). For shipments of sharps that meet 3291" and with the name and address of the consignor or consignee (see § 172.301(a) and the definition for RMW, the sharps container must be marked "Regulated Medical Waste, UN (d)). The container must be labeled with a Division 6.2 (infectious substances) label. Only shipping name. When transported by a private or contract carrier, RMW, including sharps, in one label is required to be displayed on a non-bulk packaging in association with the proper a non-bulk package is excepted from the requirement for a Division 6.2 label if it is marked with a "BIOHAZARD" marking in accordance with regulations of the Occupational Safety and Health Administration at 29 CFR 1910.1030 (see § 173.134(c))). RMW A Division 6.1 (POISON) label is not authorized under the HMR for packages containing I hope this satisfies your inquiry. If we can be of further assistance, please contact us. Sincerely, Whos thog Susan Gorsky Office of Hazardous Materials Standards Senior Transportation Regulations Specialist#

Page 3Message Page 1 of 2 Gorsky, Susan From: Cushmac, George Engrum Sent: Monday, October 20, 2003 8:03 AM To: Gorsky, Susan $113.191 Cc: 'terry@daniels.com.au'; Cushmac, George Subject: FW: Labelling sharps containers Regulated Medical Waste Susan, 03-0265 regarding DOT requirements for the labelling of sharps containers (see e-mail message Per our conversation earlier this morning, I am forwarding a question from Terry Grimmond below). Please respond directly to Mr. Grimmond. Thanks, George ----Original Message-.... Sent: Friday, October 17, 2003 4:48 PM From: Terry Grimmond [mailto:Terry@daniels.com.au] To: Cushmac, George Subject: Labelling sharps containers Don Burger suggested 1 put my Q to you. I am enquiring re DOT requirements for the labelling of sharps Dear Dr Cushmac, containers. My company produces a reusable sharps container that has passed UN requirements for certification as a TDG requirements. econdarv container on wheels. V "UN 3291" compulsory?) Q1. What must be shown on a sharps container label? (ie, is the UN biohazard diamond compulsory in USA; is shown on a sharps container label? (ie, is the UN biohazard diamond used in USA or should it be the skull 8 22. For the use of reusable sharps containers for disposal of chemotherapeutic sharps waste, what must be Crossbones 6.1 diamond? Or both?). Q3. If diamonds are required, are they required on opposite sides of the container? I have read the DOT regs fairly thoroughly but cannot see where small container labelling is covered. Kind regards, Terry Grimmond Clinical Director, The Daniels Corporation 3 Tarbett Rd Hillcrest, Hamilton 2001, New Zealand Ph/Fx) +64 7 856 4042 Mob (NZ): +6125,365 140 10/20/03#