RCS, Inc. - Ohio — Hazardous Materials Safety Interpretation

Page 1us anorion JAN M2 2003 400 Seventh St., S.W. Research and Washington, D.C. 20590 Special Programs Administration Mr. Jeff Henderson RCS, Inc. - Ohio Reference No.: 02-0309 950 Taylor Station Road Gahanna, OH 43230 Dear Mr. Henderson: This is in response to your letter concerning the exceptions for Consumer commodities, ORM-D, under the Hazardous Materials Regulations (HMR; 49 FR Parts 171-180). Specifically, you ask if your products, Intravenous starting kits and Dressing change kits, that contain an alcohol that the swabs contain 2 to 10 mL of alcohol or alcohol and iodine solution and are packaged in a pad and/or an iodine/alcohol swab may be shipped as Consumer commodity, ORM-D. You state hermetically sealed pouch. The pouch contains free liquid when manufactured. These products are shipped to hospitals and health care facilities. In general terms, a consumer commodity, as defined in 49 CFR 171.8, is a material that is packaged and distributed in a form intended or suitable for sale through retail sales agencies or instrumentalities for consumption by individuals for purposes of personal care or household use. The definition includes materials that are suitable for retail sale even if not specifically so intended and which may, in fact, be used in some other fashion. It is the opinion of this office "Consumer commodity, ORM-D." that the Intravenous starting kits and Dressing change kits would qualify for shipment as I hope this satisfies your request. Sincerely, Hollez. mitkell Hattie L. Mitchell Chief, Regulatory Review and Reinvention Office of Hazardous Materiais Standards 020309 171.8#

Page 2Corbin RCS $171.8c) Consummer Commodite November 26, 2002 02 - 0309 Research and Special Programs Administration 400 7* Street SW DHM-10. Washington D.C. 20590-0001 Attn: Edward Mazzullo-Director of the Office of Hazardous Materials Standards.. Re: Letter of Interpretation under the Consumer Commodity Definition Dear Mr. Mazzullo, The following, requests a letter of interpretation regarding the applicability of the defirition of a Consumer Commodity as stated in 49 CFR 171.8. RCS, Inc's products, requesting interpretation, are Intravenous (IV) Starting Kits and client, Becton Dickinson, manufactures and ships medical products. Dressing Change Kits, which contain an Alcohol pad and/or an lodine/Alcohol Swab.: These. products are shipped to hospitals and health care facilities for patient care purposes Alcohol. and lodine Swabs consist of 2 ml to 10ml of alcohol or alcohol and iodine solution. The swabs are packaged in a hermetically sealed pouch and contain free liquid when manufactured. These products are regarded by the FDA *as being Generally Regarded as Safe an Effective (GRASE) under the Tentative" Final Monograph for Health-care Antiseptic Drug Products. specialized use in changing patient dressing or starting an IV. Dressing Change Kits and IV Starting Kits are prepackaged products for Within the prepackaged kits are Alcohol or Alcohol and lodine Swabs identical to those with a Tyvek lid to maintain sterility and prevent breakage during transport or outlined above. IV Start Kits are packaged in a thick plastic pouch and sealed handling. Dress Change Kits are packaged in rigid plastic trays and sealed with •a plastic pouch to prevent breakage during transportation and handling. A letter of interpretation is requested to allow for shipment of the above products as Consumer Commodity, ORM-D materials. While the above products are manufactured and intended for clinical use, the type of packaging utilized for the • products can be suitable in household use or personal care. "Under the current definition, a Consumer Commodity means a material that is packaged and distributed in a form intended or suitable for sale through retail#

Page 3sales agencies or instrumentalities for consumption by individuals for purposes of personal care or household use. This term also includes drugs and medicines It is the opinion. of Becton Dickinson and RCS, Inc. that the above mentioned products can • classified as Consumer Commodity, ORM-D materials. Therefore, it is requested that a letter of interpretation be formed to acknowledge If the above products may be shipped as a Consumer Commodity, ORM-D materials. Additional information regarding the above products can be obtained from the following sources: Becton Dickinson Rand Pugmire Jeff. Henderson RCS, Inc. 9450 South State St. 950 Taylor Station Rd, St M Phone: 801-565-2550 Sandy, UT 84070 Phone: 614-552-8530 x 31 Gahanna, OH 43230 Fax: 801-565-2749 Fax: 61.4-552-8541 send a hard copy to the above fax numbers and addresses. Your cooperation Upon determination and completion of a letter of interpretation, please fax and: and timeliness is greaty appreciated.: Sincerely Jeff Henderson Technical Consultant RCS, Inc.#