{"operation":"document","citation":"09-0094","title":"Roche Molecular Systems, Inc. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2009-07-03","effective_on":null,"summary":"09-0094 response to Roche Molecular Systems, Inc. concerning 173.4.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-09-0094.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-09-0094.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-09-0094","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretations/2009/090094.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department of Transportation Pipeline and Hazardous Materials\nSafety Administration\n1200 New Jersey Ave, S.E.\nWashington, D.C. 20590\nMs. Julie Park\nSr. Safety & Environmental Professional\nRoche Molecular Systems, Inc.\n1080 U.S. Highway 202 South\nBranchburg, NJ 08876\nRef. No. 09-0094\nDear Ms. Park:\nThis responds to your April 22, 2009, request for clarification of the requirements for\ntransporting small quantities of hazardous materials under the Hazardous Materials\nRegulations (HMR; 49 CFR Parts 17 1 - 1 80). Specifically, you request clarification\nconcerning whether packages that pass the tests specified in the International Safe Transit\nAssociation (ISTA) Procedure 2A conform to the testing requirements specified in\n$ 173.4(a)(6).\nAccording to your letter, your company manufactures and ships a variety of medical\nchemical testing kits that are tested in accordance with ISTA Procedure 2A. The ISTA\nProcedure 2A test protocols include vibration, free fall drop, and compressive load tests. The\nchemical kits are overpacked into double wall corrugated cardboard boxes for shipment.\nSection 173.4 sets forth the conditions under which certain hazardous materials may be\ntransported utilizing the exception for small quantities. Section 173.4(a)(6) requires each\ncompleted package, as demonstrated by prototype testing, to be capable of sustaining each of\nthe drop tests in 9 173.4(a)(6)(i) (A) through (E) and the compression test in 9 173.4(a)(6)(ii).\nIt is the opinion of this Office that the ISTA Procedure 2A testing protocols demonstrate that\na package is capable of sustaining the drop tests and compression test if the drop height is\nadjusted to the 1.8m (5.9 feet) required by 5 173.4(a)(6)(i). Thus, packages that pass the\nISTA 2A tests may be transported in accordance with the small quantity exception in 9 173.4\nprovided all other listed conditions are met.\nI hope this answers your inquiry.\nCharles E. Betts\nDevelopment\nMaterials Standards\n\n<<<PAGE 2>>>\n\nApril 22, 2009\nU.S. DOT PHMSA Office of Hazardous Materials Standards\nAttn: PHH-10\nEast Building\n1200 New Jersey Avenue, SE.\nWashington, DC 20590-0001\nSubject: REQUEST FOR INTERPRETATION\nDear Sir or Madam\nThis letter requests your formal interpretation as to whether ISTA Procedure 2A package testing\ncan be used to meet the requirement for package testing specified in 49 CFR 173.4(a)(6).\nRoche Molecular Systems, Inc. manufactures and ships a variety (approximately 100) different\nmedical testing kits all of which contain several small vials of non hazardous materials and one\nto three vials or cassettes containing 7-14 mls (maximum of 21 mls total) of either isopropanol,\nsodium hydroxide or sulfuric acid, depending on the specific kit. Kits containing the vials of\nhazardous material are classified as UN3316 Chemical Kits.\nWhen shipped within the United States, we offer the chemical kits for transportation in\naccordance with the Small Quantity Exception in 49 CFR 173.4. Paragraph (a)(6) of this\nexception requires that the co~mpleted package, as demonstrated by prototype testing, be\ncapable of sustaining, drop and compressive load tests as specified in that section. We\nbelieve that ISTA Procedure 2A fulfills that requirement.\nISTA Procedure 2A tests are conducted on every chemical kit manufactured by Roche\nMolecular. Every kit undergoes this testing before it is offered for transportation and any time a\nchange is made either to the components of the kit, the number of vials in the kit or the package\ndesign, the test is repeated. No kit is shipped until the kits pass the test. ISTA Procedure 2A\ntest protocols, which are attached for your review, include a vibration, free fall drop test and\ncompressive load test. Kits which pass these tests are then overpacked into double wall\ncorrugated cardboard boxes for shipment.\nWe believe the ISTA Procedure 2A testing coupled with the overpacking of the test kits prior to\nshipment meets the requirement to ensure packages can pass the tests included in 49 CFR\n173.4(a)(6). It is our belief therefore that additional testing of our chemical kits is not necessary.\nWe look forward to your response.\nSincerely, A\nSr. Safety and Environmental Professional\nRoche Molecular Systems, Inc.\n1080 US Highway 202 South\nBranchburg, NJ 08876\n908-253-71 36\niulie.~ark@roche.com\nRoche Molecular Branchburg Township\nSystems, Inc. 1080 U.S. Highway 202\nSomerville. New Jersey 08876-3771","truncated":false,"body_characters":4432}