Vital Diagnostics — Hazardous Materials Safety Interpretation

Page 1U.S. Department of Transportation Pipeline and Hazardous Materials Safety Administration ju?! 1 7 2008 Ms. Sheila Hardy VP, General Manager Vital Diagnostics 1075 Larnbert Road, Unit D Brea, CA 9282 1 1200 New Jersey Avenue. SE Washington, D.C. 20590 Ref. No. 08-0 105 Dear Ms. Hardy: This responds to your letter requesting verification of the classification of one of your products under the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). Specifically, you ask whether a solution containing 99.1% water and 0.9% picric acid would be regulated under the HMR. Under 9 173.22 of the HMR, it is a shipper's responsibility to properly classify a hazardous material for transportation in commerce. This Office does not normally perform that function. Although you did not provide any additional information relevant to your products 5 18-01 8 and 5533 1, it is the opinion of this Office that these solutions do not meet the definition of a hazardous material and, thus, are not subject to the requirements of the HMR. I trust this satisfies your inquiry. Please contact us if we can be of further assistance. Sincerely, Hattie L. Mitchell Chief, Regulatory Review and Reinvention Office of Hazardous Materials Standards#

Page 2D I A G N O S T I C S Memorandum Date: April 2, 2008 From: Sheila Hardy VP, General Manager Vital Diagnostics, Brea, CA To: Ed Mazzullo, Director Office of Hazardous Materials Standards Dear Sir, I am writing you to request your assistance in verifying the classification of the Picric Acid (Trinitropheno1)-containing solution in our products 518-01 8 and 55331. 1 understand that the PHMSA does not classify products. I am only requesting verification of the classification of this solution as non-regulated. The picric acid solution in question contains 99.1% water and 0.9% picric acid. It contains no other constituents. In support of our classification, I have attached a previous interpretation letter for a similar picric acid solution. It is our opinion that the regulations regarding picric acid solutions have not changed significantly since the interpretation letter of June 2000, even with the entry of UN3644 in the Hazardous Material Table. I appreciate your consideration and look forward to your response. Providing Vital Solufions for Your ~aborafory ''#