Interpretation Response #09-0062
Below is the interpretation response detail and a list of regulations sections applicable to this response.
Interpretation Response Details
April 16, 2009
Mr. Stephen C. Powell
Container-Quinn Testing Laboratories, Inc.
170 Shepard Avenue
Wheeling, IL 60090
Ref. No.: 09-0062
Dear Mr. Powell:
This in response to your March 18, 2009 letter regarding the drop test requirements specified in the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) for a combination packaging intended for the transportation of regulated medical waste (RMW). The combination packaging consists of a UN 4H2 plastic container with an inner 3-mil polyethylene bag. You ask for clarification of the failure criteria in § 178.603(f)(4) and specifically if it is acceptable for the inner packaging to develop punctures and ¼" to ½" holes upon impact if there is no leakage of the filling substance.
The answer is no. As you correctly noted in your letter, §178.603(f)(4) states a combination packaging passes the drop test if there is no damage to the outer packaging likely to adversely affect the packaging during transport, and there is no leaking of substance from the inner packaging. It is the opinion of this Office that an inner packaging of a combination packaging that develops punctures and ¼" to ½" holes after the drop test does not meet the requirements in §178.603(f)(4) and, therefore, does not pass the drop test. The inner packaging"s inability to resist punctures and holes during testing can be indicative of its integrity under transportation conditions.
Please note that, in accordance with § 173.197(e)(1), plastic film bags used as inner packagings for solid RMW must be marked and certified by the manufacturer as having passed the tests for tear resistance in ASTM D 1922, "Standard for Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method," and for impact resistance in ASTM D 1709, "Standard for Test Methods for Impact Resistance of Plastic Film by the Free-Falling Dart Method." The film bag must meet an impact resistance of 165 grams and a tear resistance of 480 grams in both the parallel and perpendicular planes with respect to the length of the bag.
I hope this information is helpful. If you have further questions, please do not hesitate to contact this office.
Hattie L. Mitchell
Chief, Regulatory Review and Reinvention
Office of Hazardous Materials Standards
|§ 173.197||Regulated medical waste|