Patterson Companies, Inc. — Hazardous Materials Safety Interpretation

Page 1U.S. Department 1200 New Jersey Avenue SE of Transportation Washington. DC 20590 Pipeline and Hazardous Materials Safety Administration JAN 052012 Mr. Robb Boros Compliance Coordinator Patterson Companies, Inc. Patterson Logistics Services, Inc. 1905 Lakewood Drive Boone, Iowa 50036 Ref. No. 11-0142 Dear Mr. Boros: This is in response to your letter, and subsequent conversation with a member of my staff, requesting clarification of the Hazardous Materials Regulations (HMR; 49 CPR Parts 171180) applicable to a suture product and needle packaged in a hermetically-sealed foiled pouch containing between 1.2 mL and 1.5 mL of an isopropanol-based wetting agent with a flashpoint of 12°C. In your letter, you state that upon opening a sample of your client's foil pouch, free liquid was visibly present. You ask whether the proper shipping name "Solids containing flammable liquids, n.o.s." is appropriate, and, is therefore subject to the HMR. Based on the scenario described in your letter, the answer is no, you may not use the proper shipping name "Solids containing flammable liquids, n.o.s." Further, it is the opinion of this Office that your client's product is fully subject to the requirements of the HMR and another description must be selected appropriate to the packaged substance. The proper shipping name "Solids containing flammable liquids, n.o.s.," in the § 172.101 Hazardous Materials Table refers the reader to § 172.102(c)(I) Special provision 47. Special provision 47 excepts from the HMR sealed packets that contain less than 10 mL of a flammable liquid in Packing Group II or III when the liquid is completely absorbed onto a solid material. Although your client's product contains less than 10 mL of a flammable liquid, the liquid is not completely absorbed onto a solid material and free liquid is visible. I trust this satisfies your inquiry. Please contact us if we can be of further assistance. Sincerely, Chief, Regulatory Review and Reinvention Branch Standards and Rulemaking Division#

Page 2Corporate Office 1031 Mendota Heights Road PATIERSON Fax 651.686.9331 Saint Paul, Minnesota 55120 Main 800.328.5536 COMPANIES, INC. www.pattersondental.com June 9, 2011 Office of Hazardous Materials Standards Pipeline and Hazardous Materials Safety Administration Attn: PHH-lO, U.S. Department of Transportation 1200 New Jersey Avenue, SE, East Building Washington, DC 20590-0001 I have been speaking with Adam in the Hazmat Information Center in an effort to obtain confirmation that the product described below is subject to the HMR. Although he did provide verbal confirmation, I am in need of a written response. The suture product in question consists of an 18" length of catgut attached to a small curved needle. The suture and needle are placed in a hermetically sealed foil pouch with between 1.2ml and 1.5ml of an Isopropanol based wetting agent. The sealed foil packet is further sealed in another plastic/paper pouch. Each selling unit consists of twel ve packets in a heavy paper sleeve. Printed on the bottom panel of the selling unit it states "When product is packaged in fluid each package contains:" then lists the components that comprise the wetting agent. [See sleeve.pdf] The MSDS provided by our supplier indicates the wetting agent solution possesses a flash point of 12°C and is identified as UN1219, Isopropanol solutions, a class 3 packing group II flammable liquid. [Wetting Agent SDS.pdf] In a conversation with the supplier of the suture product, they stated the wetting agent is a free liquid. Upon opening and inverting the foil packet, liquid was present. Am I accurate in my understanding based on the information provided that when packaged with the alcohol-based wetting agent, the suture product is subject to the requirements of the HMR? Sincerely, Robb Boros Compliance Coordinator Patterson Companies, Inc. Patterson Logistics Services, Inc. 1905 Lakewood Drive Boone, Iowa 50036 515.433.1700#