Artegraft, Inc. — Hazardous Materials Safety Interpretation

Page 1U.S. Department 400 Seventh St., S.W. of Transportation Washington, D.C. 20590 Research and Special Programs Administration OCT 3 2000 Ms. Cathy VanDerVeer Ref. No. 00-0229 Artegraft, Inc. P.O. Box 7305 North Brunswick, NJ 08902 Dear Ms. VanDerVeer: I am responding to your August 11, 2000 letter regarding the definition of a consumer commodity under the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) as it applies to Artegraft's alcohol based "Sterilizing Solution." You stated that your company's sterilizing solution is an alcohol based sterilant utilized in the manufacturing process of an Artegraft. An Artegraft is an all collagen vascular access graft used by physicians. The sterilizing solution is 50% ethyl alcohol with the remaining balance being water. The product is a Class 3 (flammable liquid) in Packing Group III, in accordance with §§ 173.120 and 173.121, and described as "Ethyl alcohol solutions." The product is packaged in 500-milliliter inner containers, placed in a Styrofoam box, and then packaged in an outer fiberboard box. The boxes are overpacked in a fiberboard box with a higher burst/edge crush strength. The outer packaging contains from 1 to 10 units depending upon the quantities ordered. The total weight of the packages range from 4 pounds to 34 pounds. Specifically, because the components of Artegraft's sterilant are similar to many alcohol based household sterilants, you believe that the alcohol based sterilizing solution meets the definition of "Consumer commodity, ORM-D." The definition of a consumer commodity in § 171.8 includes a material that is packaged and distributed in a form suitable for retail sale for consumption by individuals for purposes of personal use or household use even if not specifically so intended. We agree that the Artegraft alcohol based sterilizing solution described in your letter is suitable for household use and qualifies to be described and classed as a "Consumer commodity, ORM-D." I hope this satisfies your inquiry. If we can be of further assistance, please contact us. Sincerely, my Hasells Delmer F. Billings Chief, Regulations Development Office of Hazardous Materials Standards 000229#

Page 2Artegraft Engrum 5/71.8 August 11, 2000 Consummer Commodity VIA US MAIL AND FACSIMILE Mr. Edward Mazzullo, Director Office of Hazardous Materials Standards U.S. Department of Transportation Research and Special Programs Administration 400 7"* Street, S.W. Washington, DC 20590 Dear Mr. Mazzullo: I am requesting formal written confirmation that the product known as the Artegraft Sterilizing Solution is a consumer commodity within the meaning of 49 C.F.R. 171.8 (pg 76 in the 10-01-99 edition). process of an Artegraft. An Artegraft is an all coilagen vascular access graft. This graft is utilized The Artegraft Sterilizing Solution is an alcohol based sterilant utilized in the manufacturing by physicians. The Sterilizing Solution is 50% ethyl alcohol with the remaining balance being water. The MSDS for the alcohol is attached. box and labeled appropriately. These packages are then packaged inside a fibreboard box. The product is packaged in 500-mililiter containers. The containers are packaged in a Styrofoam These boxes are then packaged inside of another fibreboard box with a higher burst/edge crush strength. (Outer packaging varies from 1 to 10 units dependent upon order quantity) The total weight of the packages range from 4 pounds to 34 pounds. considered hazardous material under Title 49. The Artegraft is classified as "ethyl alcohol I understand that because the packages contain 50% of ethyl alcohol, the Artegraft product is solution and is assigned a packing group Ill. These classifications are determined under 49 CFR 173.120 and 173.121. The flash point of the solution is 78°F (Closed Cup). (see attached) Artegraft can be considered a consumer commodity under 49 CFR 171.8. As such, if shipped in We feel that because the steriliant solution resembles many alcohol-based consumer products. limited quantities, Artegraft can lawfully be labeled "ORM-D" and shipped as a consumer commodity under 49 CFR 173.150 (c). Shipments of ORM-D materials are not subject to the shipping paper requirements (unless transported by air). Artegraft, Inc. P.O. Box 7305 North Brunswick, NJ 08902 732-422-8333 Fax 732-422-8647 800-631-5264#

Page 3Mr. Edward Mazzullo Page 2 August 11, 2000 called Vapo-Steril that it could be shipped consumer commodity, Ref No. 99-0108. (see For example, the Office of Hazardous Materials Standards issued an explanation of a sterilant attached). well as, our distributors. I would like to request a written response, as soon as possible, as to Your response to the above inquiry has very significant impact on us, as the manufacturer, as whether the Artegraft steriliant would qualify as a consumer commodity. Sincerely, CUDI Office Manager Cathy VanDerVeer Attachments (3)#