Interpretation Response #02-0021 ([Sharps Compliance] [Edward Krisiunas, MT (ASCP), CIC, MPH])

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

Interpretation Response Details

Response Publish Date: 01/30/2002

Company Name: Sharps Compliance

Individual Name: Edward Krisiunas, MT (ASCP), CIC, MPH

Location State: TX Country: US

View the Interpretation Document

Response text:

January 30, 2002

Edward Krisiunas, MT (ASCP), CIC, MPH                 Reference No. 02-0021
Sharps Compliance
9050 Kirby Drive
Houston, TX 77054

Dear Mr. Krisiunas:

This responds to your request during a November 28, 2001 telephone conversation with Ms. Eileen Edmonson of my staff for written confirmation of a response you received from her by electronic mail on November 13, 2001.  You asked whether an unmarked sharps-disposal-by mail combination packaging, approved for use by the U.S. Postal Service (USPS) under authorization no. 035J, fulfills the requirements for a sharps regulated medical waste packaging prescribed in § 173.197 of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180).

You also enclosed in an October 19, 2001 electronic mail message a copy of pages C-19 through
C-36 of the USPS Domestic Mail Manual Issue 56 plus Postal Bulletin changes through PB 22060 (10-4-01) that require a sharps packaging approved for use by the USPS to conform to the following packaging performance tests in the HMR: §§ 178.604 (leakproof), 178.606 (stacking), 178.608 (vibration), and 178.609 (infectious substance packaging).  On November 8,2001, you supplied this office with an example of the packaging, a rigid 4.8-quart polyethylene bottle inside a polyethylene bag inside a fiberboard box, but did not provide its performance test results.

Under §§ 178.2 and 178.3, the manufacturer identified on a packaging or the person placing the UN symbol on the packaging is responsible for ensuring that the packaging meets the UN standard to which it is certified.  However, based on the information you provided, it is the opinion of this office that the sharps combination packaging you described would conform to §§ 173.197 and 178.609 provided it successfully passes all prescribed performance tests for these packagings in 49 CFR Part 178 and these results are documented and maintained, as required in § 178.601(1).  Further, the packaging that complies with § 173.197 must be marked, as required in 49 CFR Part 178, Subpart L, with the symbols representing its design specification.

I hope this satisfies your request.

Sincerely,

John A. Gale
Transportation Regulations Specialist
Office of Hazardous Materials Standards

173.197

Regulation Sections