Container-Quinn Testing Laboratories, Inc. — Hazardous Materials Safety Interpretation

Page 1U.S. Department of Transportation Pipeline and Hazardous Materials Safety Administration 1200 New Jersey Ave, S.E. Washington, D.C. 20590 Mr. Stephen C. Powell Lab Director 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 17 1-1 80) 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 fj 178.603(0(4) and specifically if it is acceptable for the inner packaging to develop punctures and Yt" to %" holes upon impact if there is no leakage of the filling substance. The answer is no. As you correctly noted in your letter, fj 178.603(0(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 ?A" to %" 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 9 173.197(e)(l), 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. 1 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#

Page 2CONTAINER-QUINN TESTING LABORATORIES, INC. A division of H.H. Holmes Testing Laboratories, 1nc: 170 Shepard Avenue Wheeling, IL 60090 knd"& Phone: 847-537-9470 Fax: 847-537-9098 e-mail: spowell6j)container-quinn.com 3 17% ~03,&c)@) Te5-6 ny 18 March 2009 by-006z Mr. Edward T. Mazzullo Director, Ofice of Hazardous Materials Standards US DOT I PHMSA (PHH-10) 1200 New Jersey Avenue, SE East Building, 2" Floor (PH) Washington, DC 20590 Mr. Mazzullo; Re. SA-9009004, ID Code +AX RMW testing of a combination package After discussion with Anthony Lima, USDOT and at his suggestion, I am requesting an interpretation and clarification of passlfail criteria in the testing of a Regulated Medical Waste (RIMW) container. With IWr Lima as an observer, I conducted testing of a 4H2 plastic container, for use with RMW. Description is as follows: UN 4H2 17-gallon oblong openhead plastic container with sliding transport cover containing one (1) 3-mil polyethylene red bag. Bag is secured by twisting the top and then tightly knotting it. Container is secured with cable ties. Test weight is 15.9kg. Drop height was 1.2M During the testing, the redbag is removed and inspected after each individual drop. 'There were some holes (114" to W ) and punctures found in the bag after the drops but bag integrity was intact (bag was lifted completely out of the container and inspected). As per 49CFR, 178.603(9(4), "For a composite or combination packaging, there is no damage ks the outw packaging likely $0 adverse@ affect safety during trans~ort, and there is no leakage of t h e fillrng substance f o m the inner packaging;" Under this section, as the bag was able to contain all product within and the outer container showed no damage, I considered this to be a pass. Mr Lima raised a concern with the holes in the bag and whether this compromised the test. This is the area that is under question, whether these holes and punctures are acceptable and, as the bag does contain all the inner product, if this should be considered a pass in accordance with the Criteria for Passing the Test as listed above. Thank you for your assistance in this matter. Sincerely - --+. Stephen C. Powell Lab Director Container-Quinn Testing Laboratories, Inc. Cc: Mr. Anthony Lima, US DOTIPHMSA#