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U.S. Department of Transportation U.S. Department of Transportation Icon United States Department of Transportation United States Department of Transportation

Interpretation Response #09-0300 ([Sartorius Stedim Filters, Inc.] [Mr. José H. Braulio-Martinez])

Below is the interpretation response detail and a list of regulations sections applicable to this response.

Interpretation Response Details

Response Publish Date:

Company Name: Sartorius Stedim Filters, Inc.

Individual Name: Mr. José H. Braulio-Martinez

Country: PR

View the Interpretation Document

Response text:

May 4, 2011




Mr. José 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 of my staff, and e-mails 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 if these filters are excepted from regulation as a Division 4.1 material under the requirements prescribed in Special Provision (SP) 43 of § 172.102 of the 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. 10045-10047) for these filters that were prepared on April 22, 2010, by Stresau Laboratory, Inc., for Speciality Disposal Services, Inc., of Mountain Lakes, NJ.

You state the filters are manufactured in the shape of a 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) of nitrocellulose. You also state the package consists of an 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 of the base and held in place with two pieces of tape 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 of this 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 of a Division 4.1, PG 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 100 mm in 7.95 second, and a wetting agent did not inhibit the propagation of combustion." 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 explosive flames. Based upon this information, it appears that your product has the potential of being a self-ignition source. If this is the case, your product is forbidden from transportation commerce based on the requirements of § 173.21(f). Third, although you did not provide the mass of all 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.


T. Glenn Foster

Chief, Regulatory Review and Reinvention Branch

Standards and Rulemaking Division

173.22, 173.124, 173.21

Regulation Sections

Section Subject
173.124 Class 4, Divisions 4.1, 4.2 and 4.3-Definitions
173.21 Forbidden materials and packages
173.22 Shipper's responsibility