Sartorius Stedim Filters, Inc. — Hazardous Materials Safety Interpretation

Page 1U.S. Department of Transportation 1200 New Jersey Avenue, SE WAY ,., 4 2011 Washington, OC 20590 Pipeline and Hazardous Materials Safety Administration Mr. Jose H. Braulio-Martinez Sartorius Stedim Biotech Supply Chain Manager Sartorius Stedim Filters, Inc. Road 128 Int 376, P.O. Box 6 Yauco, Puerto Rico 00698 Reference No. 09-0300 Dear Mr. Braulio-Martinez: This is in response to your letter, telephone conversations with a member ofmy staff, and emails concerning "UN 3270, Nitrocellulose membrane filters, with not more than 12.6% nitrogen, by dry mass, 4.1 (flammable solid), Packing Group (PG) II," your company manufactures and distributes. You ask ifthese filters are excepted from regulation as a Division 4.1 material under the requirements prescribed in Special Provision (SP) 43 of § 172.102 ofthe Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). On July 22, 2010, you provided this Office with United Nation's (UN) Gap, Scientific Weight, and Burn Rate test results (Laboratory Report No.1 0045-1 0047) for these filters that were prepared on April 22, 2010, 1:>Y Stresau Laboratory, Inc., for Speciality Disposal Services, Inc., of Mountain Lakes, NJ. You state the filters are manufactured in the shape ofa circular disc and range in diameter from 13 millimeters (0.51 inches) to 90 millimeters (3.54 inches). You state the largest filter contains 0.42 grams (0.02 ounces) ofnitrocellulose. You also state the package consists ofan inner packaging that contains 100 filters in one sealed packet with wax paper separators between each filter, the packets are then placed in a plastic tray base, a tray cap is closed onto the top ofthe base and held in place with two pieces oftape on opposite sides, and several closed tray packagings (e.g., 1,000 discs) are placed in one non-specification fiberboard box. Under § 173.22, it is a shipper's responsibility to properly classify and describe a hazardous material. This office does not normally perform that function. However, based on the information you provided, it is the opinion ofthis office that the nitrocellulose membrane filters you describe do not qualifY for the two exceptions prescribed in SP 43. First, the laboratory test results do not support their entire exclusion from the HMR. The filters meet the definition ofa Division 4.1, PO II material, as defined by UN and U.S. Department of Transportation criteria for testing flammable solids (see Modified UN Division 4.1 Burn Rate Test N.1 and 49 CFR 173.124(a)), because "the sample ignited and traveled a distance of 1 00 mm in 7.95 second, and a wetting agent did not inhibit the propagation ofcombustion." Second, as stated in your company's material safety data sheet, improperly stored nitrocellulose membrane filters may decompose and produce nitrous vapors or self-ignite, and when exposed to fire may also produce#

Page 2explosive flames. Based upon this information, it appears that your product has the potential of being a self-ignition source. Ifthis is the case, your product is forbidden from transportation commerce based on the requirements of § 173.21(t). Third, although you did not provide the mass ofall the filters your company manufactures, you did state the largest filter weighs 0.42 grams. Therefore, please note that your company's packaging of 100 filters in one sealed packet will exceed the 0.5 gram limit that SP 43 requires to be enclosed individually within an article or sealed packet to be excepted from the HMR. I hope this satisfies your request. Sincerely, c-7'//~~ T. Glenn Foster Chief, Regulatory Review and Reinvention Branch Standards and Rulemaking Division 2#

Page 3Sartorius-Stedim Rlters, Inc, Road 126 Int 376, Yauco, Puerto Rico 00696 ~CH) 0 • '''000 0$00 • sartorius • "oeo .0000 Edtnanf>tJn biotech ~ 112. ./()1 ~ )1'2... 1()'2. SP-y~ COpe e c a. \ Pro VI bf~ (').!. DQ-6-S0D Contact: Sartorius-Stedim Filters, Inc. PO Box 6 Yauco, Puerto Rico 00698 Phone: 787-856-5020 Fax: 787-856-1292/1-631-253-5104 www.sartorius-stedim.com Email: jose.braulio@sartorius-stedim.com Date: 4 December 2009 Dear Sir I Madam Sartorius Stedim Filters submit this request for interpretation. We produce and ship Nitrocellulose membrane filters discs; UN number UN3270. These are 13mm to 90mm in diameter and packed in quantities of 1,000 discs. They are packed with waxed paper disc separators between each filter disc, placed in a plastic tray (tray base and cap); tray-cap are closed with two glued~tape pieces at opposite side and then placed in shipping fiberboard boxes. The amount ofNitrocellulose per disc is 0.42 g in the largest disc. Our request for interpretation is ; based on the Nitro cellulose amount and packaging type; can we ship as non-hazardous based on 49 CFR parts 171~180; Special Provision 43. Ifyou have questions I can be contacted at (787)856-5020. Thanks in advance for your response. Sincerely Jose H. Braulio Supply Chain Manager#