LSL Industries, Inc. — Hazardous Materials Safety Interpretation

Page 1J.S. Department of Transportatior 400 Seventh St., S.W. Washington, D.C. 20590 Special Programs Research and Administration NOV 17 2004 Mr. Hussein Director QA/Operations Ref. No. 04-0253 LS Industries, Inc. 5535 N. Wolcott Avenue Chicago, IL 60640 Dear Mr. Hussain: This is in response to your letter dated October 26, 2004, and subsequent conversation with a member of rny staff, regarding the small quantity exception in the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). Specifically you ask if "Disposable Kits" for hospitals qualify for the small quantity exception in § 173.4. You describe two "Disposable Kits" in your letter: (1) The first (IV Start kit #1) contains several non-hazardous materials, and 0.67 ml of Chlorhexidine Gluconate 2% in 70% Isopropyl Alcohol, which you have classified as "Isopropyl alcohol solution, 3, UN1219, PG II." (2) contains 1.5 ml of the isopropyl alcohol solution. The second kit (IV Start kit #2) has the same configuration as the first; however, it receptacle for Class 3 (Flammable) liquids. Assuming they meet the additional requirements Both of these kits meet the quantity limitation in § 173.4(a)(1)(1) of 30 ml per inner of § 173.4, and the outside of each package is marked with the statement, "This package conforms to 49 CFR 173.4," the "Disposable Kits" you described are excepted from any other requirements of the HMR. I hope this information is helpful. Please contact us if you require additional assistance. Office of Hazardous Materials Standards /72.101 040253 173.4#

Page 2Eichenlaub $172.101 5113.4. Labeling LSL Industries, Inc. Manufacturers of Quality Medical Devices & Disposable i 04-0253 October 26, 2004 Office of Hazardous Material Standard Research Special 400 Seventh Street U.S Department of Transportation South West Washington. D.C 20590-0001 Attn: DHM-10 Re: Verification of Shipping Classification Dear Sir/Madam, I am writing to you to seek your help in properly deciding any labeling requirements of Recently one of our customers enquired about labeling of a product IV Start Kits under ur shipping package. We are a small Manufacturer of Disposable Kits for the Hospitals DOT Regulation. For example the configuration of the IV Start kit # 1 is as follows: 1. IV Dressing (thin film to cover IV site) 2. Gauze (Cotton) 3. Chlorhexidine Gluconate 2% in 70% Isopropyl Alcohol (Antiseptic ampule 0.67 ml) 4. Tourniquet 5. Tape 6. Label IV Start kit # 2 has the same configuration except it contains 1.5 ml Chlorhexidine Gluconate 2% in 70% Isopropyl Alcohol. These components are packed together in a small Tyvek and moisture proof plastic pouch. 100 of these individually packaged kits are then urther packed in a small carton weighing about 6 pounds. Considering the above configuration with only 0.67 ml and 1.5 ml of antiseptic in each individual kit, we are interested in knowing the DOT labeling requirements applicable, if any, for shipping our product. Our interpretation of CFR 49& REF: 173.4 are that this product may be exempted for ORM-D labeling requirements under the small quantity clause.#

Page 3Page 2 DOT We respectfully request you to kindly verify our interpretation. If there is any regulation questions as you review this request, please feel free to call me at 773-878-1100. Thank applicable for labeling we will be glad to implement immediately. If you have an you very much for your kind consideration and favorable action. Sincerely, V. Hussain Director QA/Operations#