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Interpretation Response #99-0124 ([Arent Fox Kintner Plotkin Kahn, PLLC] [Mr. Paul Jackson Rice])

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

Interpretation Response Details

Response Publish Date:

Company Name: Arent Fox Kintner Plotkin Kahn, PLLC

Individual Name: Mr. Paul Jackson Rice

Location State: DC Country: US

View the Interpretation Document

Response text:

December 7, 1999

 

Mr. Paul Jackson Rice                     Ref. No. 99-0124
Arent Fox Kintner Plotkin
     & Kahn, PLLC
1050 Connecticut Avenue, N.W.
Washington, D.C. 20036

Dear Mr.. Rice:

This responds to your letters of May 10 and September 7, 1999, and telephone conversations with Ms. Eileen Mack of my staff, concerning the transportation requirements applicable to used sharps under the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180).
Please accept my apology for our delay in answering your inquiries.

Sharps are objects that can penetrate the skin, such as needles, scalpels, broken glass, broken capillary tubes, and exposed ends of dental wires.  Used sharps that are not contaminated with an infectious substance or any other material meeting one of the hazard classes defined in the regulations are not subject to the HMR.

For purposes of the HMR, used sharps that are contaminated with an infectious substance are considered regulated medical waste, Division 6.2. Regulated medical waste is a waste or reusable material, other than a culture or stock of an infectious substance, that contains an infectious substance and is generated in: (1) the diagnosis, treatment, or immunization of human beings or animals; (2) research pertaining to the diagnosis, treatment, or immunization of human beings or animals; or (3) the production or testing of biological products.  A package containing a regulated medical waste is subject to the HMR, whether or not that regulated medical waste is commingled with non-regulated waste.  Regulated medical waste must be packaged in packagings conforming to the requirements of Part 178 of the HMR at the Packing Group 11 performance level.  In addition, the packagings must be rigid, leak resistant, impervious to moisture, of sufficient strength to prevent tearing or bursting under normal conditions of use and handling; sealed to prevent leakage during transport; puncture resistant for sharps; and break resistant and tightly lidded or stoppered for fluids in quantities greater than 20 cubic centimeters (see § 173.197).

The HMR include several exceptions applicable to the transportation of regulated medical waste.  For example, a regulated medical waste that is transported by a private or contract carrier is excepted from the requirement that it be labeled with an INFECTIOUS SUBSTANCE label provided that the outer packaging is marked with a BIOHAZARD marking in accordance with the regulations of the Occupational Safety and Health Administration (OSHA) governing blood borne pathogens (29 CFR 1910.1030). A regulated medical waste that is transported by a private or contract carrier is also excepted from the specific packaging requirements of § 173.197 provided it is packaged in a rigid, non-bulk packaging that conforms to the general packaging requirements in §§ 173.24 and 173.24a and the packaging requirements specified in 29 CFR 1910.1030.

Medical equipment that meets the definition of a Division 6.2 material and is prepared for transportation in conformance with the OSHA requirements in 1910.1030(d)(2)(xiv) is not subject to any of the requirements in the HMR (see § 173.134(b)(1)(iii). This OSHA provision applies to equipment that has been decontaminated to the fullest extent practicable.  This exception was incorporated into the HMR in 1995 to relieve generators of regulated medical waste from the burden of complying with both the HMR and the OSHA regulations.  For a discussion of the reasons for and applicability of this exception, see the preamble to the final rule published September 20, 1995 (60 FR 48780).  The exception applies to medical equipment that is intended for reuse.  The exception does not apply to medical equipment that is being transported for disposal.  For purposes of this exception, medical equipment includes equipment used for diagnosis, research, or treatment, such as reusable surgical equipment or equipment used for testing where the components within which the equipment is contained essentially function as packaging.  Used sharps are not considered medical equipment for purposes of this exception.

I hope this information is helpful.  If you have further questions, please do not hesitate to contact this office.

Sincerely,

 

Edward T. Mazzullo
Director, Office of Hazardous Materials Standards

173.134

Regulation Sections

Section Subject
173.134 Class 6, Division 6.2-Definitions and exceptions