Solutions, Inc. — Hazardous Materials Safety Interpretation

Page 1: of ransportation 400 Seventh St., S.W. Washington, D.C. 20590 MAY 23 2003 Mr. Victor B. Anderson Solutions, Inc. Reference No. 02-0222 5948 Timber Ridge Drive, Ste. 102 Prospect, Kentucky 40059 Dear Mr. Anderson: This is in further response to your letter and telephone conversations with Ms. Eileen Edmonson "Regulated medical waste, 6.2 (infectious), UN 3291, PG I," packaged in UN standard or non- of my staff. You asked if a hazardous materials carrier may transport sharps described as DOT specification packagings under the Hazardous Materials Regulations (HIMR; 49 CFR Part 171-180) that do not meet the sharps packaging requirements of the U.S. Food and Drug Administration (FDA). 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). While certain of these revised requirements, some of which are discussed below, refer to FDA requirements for sharps containers, the FDA is the lead agency in approving single-use and reusable medical devices, such as sharps containers. The HMR do not supercede these requirements. For more information on the FDA's requirements, you may wish to contact Ms. Diane Goldsberry or Ms. Carolyn Niebauer of the FDA's Centers for Devices and Radiological Health, Office of 2094 Gaither Road, Rockville, MD, 20850, at (301) 594-4618. Compliance, Division of Enforcement, General Hospital Devices Branch, HFZ-333, Under the new HIMR requirements, the following RMW packagings are authorized for Division 6.2 (infectious) sharps that are not a Risk Group 4 material: (1) a non-bulk, puncture-resistant Subpart M, as specified in § 173.197(b); (2) a puncture-resistant Large packaging capable of packaging that meets the Packing Group Il performance level requirements in 49 CFR Part 178, retaining liquids that meets the testing requirements for an intermediate bulk container prescribed in 49 CFR Part 178 in § 173.197(d)(1) and (d)(3). Inner packagings used in a Large packaging, Cart, or BOP must conform to the requirements in § 173.197(e). You also asked if an inner packaging containing sharps and a polyethylene bag containing RMW may be placed in the same outer packaging under the HMR. For non-bulk packagings, the 173.19 020222#

Page 2answer is yes. However, inner packagings in a Cart or BOP must be restricted in a manner that packaging must be separated from a plastic-film bag with rigid barriers or dividers that will minimizes breakage. See §§ 173.197(d)(2)(iv) and 173.197(d)(3)(v). Further, in a BOP, a rigid prevent damage to inner packagings from load shifts. See § 173.197(d)(3)(v). Sharps may be transported as RMW in a non-specification, non-bulk packaging by a private or contract carrier under the provisions in §§ 173.134(c)(1) and (2). A sharps container intended for reuse in a Large packaging, Cart, or BOP must be approved and certified as a medical device for reuse by the FDA and meet additional requirements under § 173.197(e)(3). Sharps meeting the definition of a Risk Group 4 material must be classed and transported as a UN 2814 or UN 2900 infectious substance in packagings tested and marked as required under §§ 173.196 and 173.503(f), tespectively. See § 173.134(a)(4). I hope this satisfies your request. Sincerely, stable z. Mittet Hattie L. Mitchell Chief, Regulatory Review and Reinvention Office of Hazardous Materials Standards#

Page 3wanderson 502-228-2931 P.2 •Solutions, inc. Corbin $173.197 August 22, 2002 Pregulated Medical Waste US Department of Transportation RSPA 02-0222 400 7th Street, S.W. DHM-10 Washington, DC. 20590 Ed Mazzulo, Director of Office of Hazardous Materials Dear Mr. Mazzulo; I am a packaging provider for the medical waste industry. I have a customer that needs to ship ater. Fleas a vise me ed my understanding i bored and that police is legal and conforms to the intent of the regulations. may reply by mail to; Please reply back to me by fax or mail'as soon as possible. Fax # 502-228-2931, You Solutions Inc. Prospect, KY. 40059 5948 Timber Ridge Drive, Suite 102 If you have any questions please feel free to call me at 502-228-2901 Thank you, Victor B. Anderson P.O. Box 1091 Prospect, Kentucky 40059 502-228-2901 fox:502-228-2931 www.a-solutionsinc.com#