TEN-E Packaging Services, Inc. — Hazardous Materials Safety Interpretation

Page 1U.S. Department of Transportation Pipeline and Hazardous Materials Safety Administration 1200 New Jersey Avenue, SE Washington, D.C. 20590 FEB 1 4 2013 Mr. Robert J. TenEyck Director, Technical Services TEN-E Packaging Services, Inc. 1666 County Road 74 Newport,~ 55055 Reference No. 12-0260 Dear Mr. TenEyck: This is in response to your November 12, 2012 letter requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to the definition of an "aerosol." In your letter, you describe a microfoam delivery system that consists of two separate 3 00 ml ( 1 0.25 ounces) canisters, one that contains "UN 1072, Oxygen, compressed, 2.2 (non-flammable compressed gas), 5.1 (oxidizer)" under 5.4 bars of pressure and the other that contains a foaming product that does not meet the definition of a Department of Transportation hazard class and "UN 1013, Carbon dioxide, 2.2" under 1.2 bars of pressure. You also state these canisters are joined together with a protective collar equipped with a safety clip and a packaging system that allows the two canisters to be twisted together, the oxygen dispensed into the canister with the foaming product, and the pressurized foaming product to be released at the time of use through the use of manometer tubing and syringe. You ask whether the microfoam delivery system meets the definition of an "aerosol." The answer is no. The HMR defines an aerosol as "any non-refillable receptacle containing a gas compressed, liquefied or dissolved under pressure, the sole purpose of which is to expel a nonpoisonous (other than a Division 6.1 Packing Group III material) liquid, paste, or powder and fitted with a self-closing release device allowing the contents to be ejected by the gas" (see§ 171.8). Based on the information you provided, the canister that contains the foaming product and carbon dioxide meets the definition of an aerosol after it has been charged with oxygen from the other canister, and this occurs when both canisters are no longer in transportation. While in transport, the canister that contains the foaming product is not under sufficient pressure at 1.2 bars of pressure to allow its product to be expelled. Further, the canister containing 300 ml of oxygen exceeds the 4 ounce capacity limit under#

Page 2§ 173.306(a)(l) that would allow it to be transported as a limited quantity. Therefore, it is the opinion of this Office that the canister containing the foaming product is not regulated as a hazardous material under the HMR, and the canister that contains the oxygen must be described as "UN 2037, Receptacles, small, containing gas (gas cartridges), 2.2, 5.1" or "UN 1072, Oxygen, compressed, 2.2." I hope this satisfies your request. Sincerely, -Y4~~ T. Glenn Foster Chief, Regulatory Review and Reinvention Branch Standards and Rulemaking Division#

Page 3November 12, 2012 Charles Betts Standards and Rulemaking, PHH-10 Office of Hazardous Materials Safety U.S. Department of Transportation Pipeline and Hazardous Materials Safety Administration £dmonson .!3 17 I· ~ ~~1~·/0_1 be-Pi tl,·f-tor1:s 12--b:LbO On behalf of the BTG International Group1 TEN-E Packaging Services is seeking a formal interpretation on a unique medical product packaging that we believe should be properly described as an "Aerosol". The aerosol system consists of 300 ml canisters locked together with a dispensing device that incorporates a protective collar. The top canister contains oxygen under a pressure of 5·4 bar and the bottom unit contains product and carbon dioxide under a pressure of 1.2 bar. The oxygen the propellant and product are separated. The design as presented in the attached schematic in essence follows the same concept in that the main propellant, the oxygen, is kept separate until the time of use. Since this package system is designed to expel a liquid under pressure we think that its classification as an aerosol is appropriate but would appreciate your input on this regulatory matter. Robert). J~ Eyck Director, Technical Services TEN-E Packaging Services, inc. Enl!e~ii: Wt<:b: wvv.wSe!l~\'!!.,~§)m#

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