BD Preanalytical Solutions — Hazardous Materials Safety Interpretation

Page 1* .. of Transportation U.S.Department 400 Seventh Street, S.W. Washington, D.C. 20590 Research and AUG 2 0 2001 Administration Special Programs • Ms. M. Wendy Bosshardt Regulatory Affairs Specialist Ref. No. 01-0101 BD Preanalytical Solutions 1 Becton Drive Franklin Lakes, NJ 07417 Dear Ms. Bosshardt: This is in response to your April 24, 2001, letter and subsequent telephone conversation with a member of my staff, requesting clarification on the small quantity exception under the Hazardous Materials Regulations (HMR; 49 CER Parts 171-180). Specifically, you ask if a vacuum (i.e., negative pressure) in each receptacle and shrink wrap around the tray and stoppered tubes meet the requirement for a positive closure as specified in § 173.4 (a) (3) of the HMR. You sent in a sample packaging for our review. To qualify for the small quantity exception, each inner receptacle with a removable closure must have the closure held securely in place with wire, tape, or other positive means. positive means of closure. [S 173.4 (a) (3)] Negative pressure in a receptacle is not a which securely holds each tube's closure in place may be used to However, shrink wrap around the tray satisiy the requirement of § 173.4 (a) (3) • Based on the sample which you submitted we note that the shrink wrap is placed loosely over the test tubes and may not ensure that test tubes in the center of the tray have their closures held in place by positive means. This could easily be corrected by placing a piece of fiberboard or other such material over the test tubes before the shrink wrap is affixed or by placing the shrink wrap tightly around the test tubes. I hope this satisfies your request. Sincerely, Transportation Regulations Specialist Office of Hazardous Materials Standards#

Page 2: - * m Becton Drive BD Preanalytical Solutions + BAH. tel: 201.847.4500 Franklin Lakes, New Jersey 07417 www.bd.com Small Quantity Exceptions 01-0101 • BD Indispensable to human health April 24, 2001 Mr. Edward T. Mazzullo Director, Office of Hazardous Materials Standards (DHM-10) Research and Special Programs Administration ('RSPA") 400 7* Street, SW U.S. Department of Transportation Washington, DC 20590-0001 Facsimile (202) 366-3012 Dear Mr. Mazzullo: Enclosed are plastic blood collection tubes for Demonstration Purposes Only with an visual purposes only. The plastic tubes are to demonstrate our belief that our product has explanation letter. We have provided plastic, unlabeled empty blood collection tubes for a positive means of closure that will support BD's certification in accordance with HMR § 173.4(a)(10). lach blood collection tube is sealed with a rubber stopper, the negative pressure of th vacuated tube provides positive means of closure and the use of plastic shrink wrappins of the seal tubes within the polystyrene tray provide further positive means of closure. Thank you for your assistance and we look forward to hearing from you. If you need any further information regarding our products please do not hesitate to contact me at (201) 847-6280. Regards, wendy sasharat M. Wendy Bosshardt Regulatory Affairs Specialist Becton, Dickinson and Company#