Health Care Waste Services — Hazardous Materials Safety Interpretation

Page 1S. Departmer f Transportatio 400 Seventh St., S.W. Research and MAY 1 2003 Washington, D.C. 20590 special Programs Administration Mr. Joseph Orlando Health Care Waste Services Reference No.: 02-0303 1370 Viele Avenue Bronx, NY 10474 Dear Mr. Orlando: This is in response to your letter asking if your company's 1.5 gallon reusable sharps container designed to transport "Regulated medical waste (RMW), 6.2, UN 3291, PG II" must comply with the requirements in 49 CFR 173.197(e)(3) for a sharps inner packaging in a non- specification bulk packaging under the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). We apologize for the delay in responding and any inconvenience this may have caused. The answer is no. The requirements in § 173.197(e)(3) apply only to a sharps packaging intended for transportation in a large packaging, wheeled cart (Cart), or bulk outer packaging (BOP). However, other requirements in the HMR do apply to non-bulk sharps containers. Section 173.197(b) authorizes the use of a non-bulk single or combination packaging that is puncture-resistant and meets the requirements in Part 178 at the Packing Group II performance level. Section 173.134(c) authorizes the use of a non-bulk, non-specification packaging that meets the general packaging requirements in 49 CFR 173.24 and 173.24a, and those of the U.S. provided the sharps are transported by a private or contract carrier. Also, note that § 173.28(f) Department of Labor, Occupational Safety and Health Administration, in 29 CFR 1910.1030, requires reusable Division 6.2 packagings to be disinfected prior to reuse. I hope this satisfies your request. Sincerely, Hothe 2 Mitchels Hattie L. Mitchell, Chief Regulatory Review and Reinvention Office of Hazardous Materials Standards 173.197 020303#

Page 2! Edmorson UrUC Health Safe Waste Services § 173 197 Regulated Medical Waste 02-0303 1370 Viele Ave. Bronx, NY 10474 TEL (718) 842-9486 FAX (718) 842-9722 November 16, 2002 Department of Transportation Office of Hazardous Materials Standards, Research and Special Program Administration 400 Seventh Street SW Washington DC 20590 Attn: Susan Gorsky Re: Federal Register Part III 49 CFR Part 171 et. al. Dear Ms. Gorsky, I have read Part III Department of Transportation 49 CFR Part 171 et. al. and have a question concerning section 173.197 Regulated medical waste (3) Sharps. My company Health Care Waste Services provides a reusable container exchange service to man› would like to verify that this section (173.197 Regulated medical waste (3) Sharps) nedical providers and one of our products is a 1.5 Gallon reusable sharps container. I or BOP. If the 1.5 gallon reusable container is not transported in Large Packaging, Cart, applies only if the 1.5 Gallon reusable container is transported in Large Packaging, Cart, 173.197 Regulated medical waste (3) Sharps Sharps transported in a Large Packaging, Cart, BOP must be packaged in a puncture- (i) The sharps container is specifically approved and certified by the U.S. Food (ii) (ili) The sharps container must be disinfected prior to reuse by any means effective (iv) for the infectious substance the container previously contaminated. The sharps container must have a capacity greater than 7.57 L (2 Gallons) and not greater than 151.42 L (40 gallons) in volume.#

Page 3I would appreciate a written response to my request as soon as possible. If you have any questions please call (718) 842-9627. Sincerely, Joseph Shorts. Health Care Waste Services dotletter.doc#