RCS, Inc. - Ohio — Hazardous Materials Safety Interpretation

Page 1of Transportation U.S. Department APR 15 2004 400 Seventh St., S.W. Washington, D.C. 20590 Special Programs Research and Administration Mr. Lead Technical Consultant Jeff Henderson Ref. No. 03-0294 950 Taylor Station Road RCS, Inc. - Ohio Suite M Gahanna, OH 43230 Dear Mr. Henderson: This responds to your letter regarding consumer commodities under Specifically, you are requesting confirmation that a medical the Hazardous Materials Regulations (HMR;49 CFR Parts 171-180). product, containing two flammable liquid components regulated under the HMR and being distributed by Baxter Healthcare Corporation, is eligible for the consumer commodity exception. The answer is yes. The definition of consumer commodity includes limited quantity provisions for the hazard class and packing drugs or medicines when packaged according to the appropriate group assigned to the material(s). It is our opinion that your transportation as a consumer commodity. client's product meets these requirements and may be offered for be of further assistance. I trust this satisfies your inquiry. Please contact us if we can Sincerely, Nathe 2 Mitchell. Chief, Hattie I. Mitchell Office Regulatory review and Reinvention of Hazardous Materials Standards 171.8 030294#

Page 2RC5 1998-2002 Estevers November 11, 2003 Consumer Commodity United States Department of Transportation Research and Special Programs Administration Definitions 400 7* Street SW 03-0294 Washington D.C. 20590-0001 Attn: Edward Mazzullo - Director, Office of Hazardous Materials Standards RE: Lotter of Interpretation under the Consumer Commodity Definition Dear Mr. Mazzullo, The following, requests a letter of interpretation regarding the applicability of the definition of a Consumer Commodity as stated in 49 CFR 171.8. RCS, Inc's requesting interpretation is an Anesthesia Tray, which may contain one of two client, Baxter Healthcare Corporation, distributes medical products. The product hazardous Applicator. components, a Compound Benzoin Tincture or a DuraPrep solution with a flashpoint of 50° F. This product is contained within a glass Compound Benzoin Tinctures consist of 0.67 ml, of a 75-80% Ethyl Alcohol ampul, placed in a sealed plastic applicator tube for use in a clinical setting. The DuraPrep Applicators are packaged in a quantity of 6 ml, and contain 60-100% Isopropyl Alcohol and 0.7% lodine, with a flashpoint of 55-85° F. The applicators Packaging of the anesthesia trays, explained above, are capable of containing are packaged in an inner glass vial contained within a plastic housing. 100% of the hazardous materials within the inner packaging. One of the above two products is combined with other non-hazardous materials utilized in a clinical setting for administering anesthesia to a patient. Products for use. When shipped, anesthesia trays are overpacked in strong fiberboard are placed in sealed plastic, within a tray for delivery to healthcare professionals packages, able to withstand shocks and stresses inherent during normal 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 utilized in a clinical setting, the type of packaging utilized for the products is suitable for household or personal use. 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 950 Taylor Station Roed- SutteM Gahanna, 43230/hone: (614) 552-8530 Fax (814) 552-8541 Website: www.4rca.com#

Page 3personal care or household use. This term also includes drugs and medicines. sales agencies or instrumentalities for consumption by individuals for purposas of It is the opinion of Baxter Healthcare Corporation, and RCS, inc., that the above mentioned products can be classified as Consumer Commodity, ORM-D materíals. Therefore, it is requested that a letter of interpretation be formed to acknowiedge if the above products may be shipped as Consumer Commodity, ORM-D materials under USDOT Hazardous Materiais Regulations. Additional information regarding the above products can be obtained from the following sources. Manager, Environmental, Health & Safety Bill Withrow Jeff Henderson Lead Technical Consultant Baxter Healthcare Corporation Deerfieid, IL 60015 One Baxter Parkway 50 Taylor Station Road, Suite A ‹CS, Inc.-Ohic 847-473-6173 314-552-8530 x 31 Gahanna, OH 43230 Upon determination and completion of a letter of interpretation, please reply to the above personnel at the listed addresses. Your cooperation and timeliness are greatly appreciated. Sincerely, Jeff Henderson Lead Technical Consultant RCS, Inc.-Ohio 614-552-8530 x 31 jahenderson@4rcs.com#