# Sartorius Stedim Filters, Inc. — Hazardous Materials Safety Interpretation

- **operation:** document
- **citation:** 09-0300
- **title:** Sartorius Stedim Filters, Inc. — Hazardous Materials Safety Interpretation
- **source type:** guidance
- **agency:** Pipeline and Hazardous Materials Safety Administration
- **status:** guidance
- **official:** true
- **published on:** 2011-05-05
- **effective on:** Not available
- **summary:** 09-0300 response to Sartorius Stedim Filters, Inc. concerning 173.124, 173.21, 173.22.
- **machine formats:** - **json:** https://regulus.evalyn.ai/document/phmsa-interpretation-09-0300.json
- **markdown:** https://regulus.evalyn.ai/document/phmsa-interpretation-09-0300.md
- **app url:** https://regulus.evalyn.ai/document/phmsa-interpretation-09-0300
- **source url:** https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretations/2009/090300.pdf
**body:**

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U.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

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explosive 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

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Sartorius-Stedim Rlters, Inc, Road 126 Int 376, Yauco, Puerto Rico 00696
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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
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