Interpretation Response #03-0265 ([The Daniels Corporation] [Ms. Terry Grimmond])

Below is the interpretation response detail and a list of regulations sections applicable to this response.

Interpretation Response Details

Response Publish Date: 11/14/2003

Company Name: The Daniels Corporation

Individual Name: Ms. Terry Grimmond

Country: NZ

View the Interpretation Document

Response text:

Nov 14, 2003

Ms. Terry Grimmond                Ref. No.: 03-0265

Clinical Director

The Daniels Corporation

3 Tarbett Rd Hillcrest

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 transported from hospitals in a large, dedicated secondary container on wheels). Your company currently supplies hospitals in the United States with these containers, and it is your understanding that the United States has adopted the international requirements for shipping infectious substances. You ask about marking and labeling requirements for the sharps containers.

We recently revised the requirements in the HMR for infectious substances, including sharps meeting the definition ofRMW, 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 Ms. Diane Goldsberry or Ms. Carolyn Niebauer ofthe 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 be durably marked or tagged with the name and location (city and state) of the offeror, except when the entire contents of the bulk packaging originates at a single location and is delivered to a single location (see § 173.l97(e)). If intended for reuse, a sharps container must be approved by FDA as a medical device for reuse and must be permanently marked for reuse (see § 173.l97(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) label 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 identification 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 ofthe 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 the definition for RMW, the sharps container must be marked "Regulated Medical Waste, UN 3291" and with the name and address of the consignor or consignee (see § 172.301 (a) and (d)). The container must be labeled with a Division 6.2 (infectious substances) label. Only one label is required to be displayed on a non-bulk packaging in association with the proper shipping name. When transported by a private or contract carrier, RMW, including sharps, in 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)).

A Division 6.1 (POISON) label is not authorized under the HMR for packages containing RMW.

I hope this satisfies your inquiry. Ifwe can be offurther assistance, please contact us.

Sincerely,

Susan Gorsky

Senior Transportation Regulations Specialist

Office of Hazardous Materials Standards

Regulation Sections