d) management reviews to ensure the effective operation of the quality system; e) a process for control of documents and their revision; f) a means for control of non-conforming aerosol dispensers; g) training programs and qualification procedures for relevant personnel; and h) procedures to ensure that there is no damage to the final product. An initial audit and periodic audits shall be conducted to the satisfaction of the competent authority. These audits shall ensure the approved system is and remains adequate and efficient. Any proposed changes to the approved system shall be notified to the competent authority in advance. Pressure and leak testing of aerosol dispensers before filling (6.2.4.2.2.2) Every empty aerosol dispenser shall be subjected to a pressure equal to or in excess of the maximum expected in the filled aerosol dispensers at 55°C (50°C if the liquid phase does not exceed 95% of the capacity of the receptacle at 50°C). This shall be at least two-thirds of the design pressure of the aerosol dispenser. If any aerosol dispenser shows evidence of leakage at a rate equal to or greater than 3.3 x 10-2 mbaržLžs-1 at the test pressure, distortion or other defect, it shall be rejected. Testing of the aerosol dispensers after filling (6.2.4.2.2.3) Prior to filling, the filler shall ensure that the crimping equipment is set appropriately and the specified propellant is used. Each filled aerosol dispenser shall be weighed and leak tested. The leak detection equipment shall be sufficiently sensitive to detect at least a leak rate of 2.0 x 10-3 mbaržLžs-1 at 20°C. Any filled aerosol dispenser which shows evidence of leakage, deformation or excessive mass shall be rejected. Special Permits Required In order to avoid the hot water bath test (for other than certain foodstuffs and certain non-flammable aerosols in plastics receptacles), the filler or manufacturer must apply for and obtain a DOT Special Permit, which can be quite a daunting task (see Spray, April 2013). Special Permit applicants must be able to demonstrate an equivalency of safety and will generally be denied a permit based on a “leveling of the playing field” approach. It is important that you can demonstrate that the methods, procedures and equipment used in pre-filling and post-filling testing will satisfy the DOT’s safety concerns. Shippers, fillers and manufacturers are strongly cautioned to ensure that they review the U.S. rules very carefully and confirm that aerosols have been subjected to and pass the hot water bath test, or an alternative method has been approved and documented in a DOT Special Permit, which is generally required to travel with the other shipping documents and/or be marked on the aerosol packaging. Failure to comply with these provisions will subject inbound loads to forfeiture and/or destruction and significant penalties, which can be in the tens or even hundreds of thousands of dollars. Additionally, import shipments that do not conform to the U.S. standards for aerosols because they have either not been subjected to the hot water bath and/or do not meet the U.S. definition of aerosols may be subjected to additional penalties because the required marks and labels or documents, for example, reflect the change in classification and are not appropriate for transport within the U.S. as aerosols. If you have any questions regarding the testing or transportation requirements for aerosols, contact the author at steve@ shipmate.com or (310) 370-3600. SPRAY July 2014 SPRAY 81
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