{"operation":"document","citation":"02-0222","title":"Solutions, Inc. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2003-05-23","effective_on":null,"summary":"02-0222 response to Solutions, Inc. concerning 173.197.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-02-0222.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-02-0222.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-02-0222","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2002/020222.pdf","body":"<<<PAGE 1>>>\n\n:\nof ransportation\n400 Seventh St., S.W.\nWashington, D.C. 20590\nMAY 23 2003\nMr. Victor B. Anderson\nSolutions, Inc.\nReference No. 02-0222\n5948 Timber Ridge Drive, Ste. 102\nProspect, Kentucky 40059\nDear Mr. Anderson:\nThis is in further response to your letter and telephone conversations with Ms. Eileen Edmonson\n\"Regulated medical waste, 6.2 (infectious), UN 3291, PG I,\" packaged in UN standard or non-\nof my staff. You asked if a hazardous materials carrier may transport sharps described as\nDOT specification packagings under the Hazardous Materials Regulations (HIMR; 49 CFR Part\n171-180) that do not meet the sharps packaging requirements of the U.S. Food and Drug\nAdministration (FDA).\nWe recently revised the requirements in the HMR for infectious substances, including sharps\nmeeting the definition of RMW, to harmonize them with international standards and incorporate\nseveral RMW exemptions (67 FR 53118, August 14, 2002). While certain of these revised\nrequirements, some of which are discussed below, refer to FDA requirements for sharps\ncontainers, the FDA is the lead agency in approving single-use and reusable medical devices,\nsuch as sharps containers. The HMR do not supercede these requirements. For more\ninformation on the FDA's requirements, you may wish to contact Ms. Diane Goldsberry or\nMs. Carolyn Niebauer of the FDA's Centers for Devices and Radiological Health, Office of\n2094 Gaither Road, Rockville, MD, 20850, at (301) 594-4618.\nCompliance, Division of Enforcement, General Hospital Devices Branch, HFZ-333,\nUnder the new HIMR requirements, the following RMW packagings are authorized for Division\n6.2 (infectious) sharps that are not a Risk Group 4 material: (1) a non-bulk, puncture-resistant\nSubpart M, as specified in § 173.197(b); (2) a puncture-resistant Large packaging capable of\npackaging that meets the Packing Group Il performance level requirements in 49 CFR Part 178,\nretaining liquids that meets the testing requirements for an intermediate bulk container prescribed\nin 49 CFR Part 178\nin § 173.197(d)(1) and (d)(3). Inner packagings used in a Large packaging, Cart, or BOP must\nconform to the requirements in § 173.197(e).\nYou also asked if an inner packaging containing sharps and a polyethylene bag containing RMW\nmay be placed in the same outer packaging under the HMR. For non-bulk packagings, the\n173.19\n020222\n\n<<<PAGE 2>>>\n\nanswer is yes. However, inner packagings in a Cart or BOP must be restricted in a manner that\npackaging must be separated from a plastic-film bag with rigid barriers or dividers that will\nminimizes breakage. See §§ 173.197(d)(2)(iv) and 173.197(d)(3)(v). Further, in a BOP, a rigid\nprevent damage to inner packagings from load shifts. See § 173.197(d)(3)(v).\nSharps may be transported as RMW in a non-specification, non-bulk packaging by a private or\ncontract carrier under the provisions in §§ 173.134(c)(1) and (2). A sharps container intended for\nreuse in a Large packaging, Cart, or BOP must be approved and certified as a medical device for\nreuse by the FDA and meet additional requirements under § 173.197(e)(3). Sharps meeting the\ndefinition of a Risk Group 4 material must be classed and transported as a UN 2814 or UN 2900\ninfectious substance in packagings tested and marked as required under §§ 173.196 and\n173.503(f), tespectively. See § 173.134(a)(4).\nI hope this satisfies your request.\nSincerely,\nstable z. Mittet\nHattie L. Mitchell\nChief, Regulatory Review and Reinvention\nOffice of Hazardous Materials Standards\n\n<<<PAGE 3>>>\n\nwanderson\n502-228-2931\nP.2\n•Solutions, inc.\nCorbin\n$173.197\nAugust 22, 2002\nPregulated Medical\nWaste\nUS Department of Transportation\nRSPA\n02-0222\n400 7th Street, S.W.\nDHM-10\nWashington, DC. 20590\nEd Mazzulo, Director of Office of Hazardous Materials\nDear Mr. Mazzulo;\nI am a packaging provider for the medical waste industry. I have a customer that needs to\nship ater. Fleas a vise me ed my understanding i bored and that police is legal\nand conforms to the intent of the regulations.\nmay reply by mail to;\nPlease reply back to me by fax or mail'as soon as possible. Fax # 502-228-2931, You\nSolutions Inc.\nProspect, KY. 40059\n5948 Timber Ridge Drive, Suite 102\nIf you have any questions please feel free to call me at 502-228-2901\nThank you,\nVictor B. Anderson\nP.O. Box 1091 Prospect, Kentucky 40059\n502-228-2901 fox:502-228-2931\nwww.a-solutionsinc.com","truncated":false,"body_characters":4386}