{"operation":"document","citation":"14-0060","title":"Safe-T- Pak, Inc. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2014-08-27","effective_on":null,"summary":"14-0060 response to Safe-T- Pak, Inc. concerning 173.134, 173.199, 173.24, 173.24a, 178.609.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-14-0060.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-14-0060.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-14-0060","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2014/140060.pdf","body":"<<<PAGE 1>>>\n\nof Transportation\nU.S. Department\nWashington, D.C. 20590\n1200 New Jersey Avenue, SE\nMaterials Safety\nPipeline and Hazardous\nAdministration\nAUG 2 7 2014\nMr. David Creighton\nRegulatory and Training Manager\nSaf-T-Pak, Inc.\n17827-111 Ave\nEdmonton, AB TSS 2X3\nCANADA\nReference No. 14-0060\nDear Mr. Creighton:\nThis is in response to your March 26, 2014 e-mail requesting clarification of the packaging\nrequirements for \"UN 3373, Biological substance, Category B, 6.2 (infectious substance)\"\nunder the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). Specifically, you\nask several questions concerning how these requirements would apply if the packaging is\ncomposed of components from sources that are different than those of the original tested\npackaging. We have paraphrased your questions and answered them in the order provided.\nQ1.\nIs it possible to alter, add, remove, or mix packaging components of a Category B\npackaging from its tested design without performing a new drop test?\nAl.\nThe answer is yes. As specified in § 173.199, a Category B packaging must be\ncapable of successfully passing the drop tests prescribed in paragraph (d) of § 178.609\nat a drop height of at least 1.2 meters (3.9 feet) but is not required to be tested using\nthis method. Capability may be demonstrated using a number of methods, including\nactual previous handling and transportation experience, design specification, or, even\nthough not required, performance testing. Category B packagings authorized under\nexceptions prescribed in § 173.134(b) are also not required to be drop tested.\nHowever, depending on the type of exception used, such packagings must meet one or\nmore of the following: the general packaging requirements prescribed in §§ 173.24\nand 173.24a, the packaging provisions of § 173.199, and/or the Department of Labor's\nOccupational Safety and Health Administration bloodborne pathogen requirements\nprescribed in 29 CFR 1910.1030.\nQ2.\nIf a shipper alters the components of a packaging that has met a tested design, is the\nshipper responsible for ensuring that the altered packaging is capable of passing the\ndrop test prescribed in § 173.199(a)(4)?\n\n<<<PAGE 2>>>\n\nA2.\nThe answer is yes. Although performance testing is not required for a packaging\nmeeting the requirements of § 173.199, the responsibility remains in effect under the\nHMR for the person who authorizes that the packaging is in compliance with that\nstandard to demonstrate it is capable of meeting a 1.2 meter drop test.\nQ3.\nIs the shipper responsible for creating new closure instructions as prescribed in\n§ 173.199(a)(10) for packagings with components that have been added, removed, or\nmixed?\nA3.\nThe answer is no. The HMR requires packaging closure instructions for DOT\nspecification and UN standard packagings that comply with the requirements in 49\nCFR Part 178 (see § 178.2(c)(1)(ii)(B)). The HMR does not require closure\ninstructions for packagings that comply with § 173.199.\nI hope this satisfies your request.\nSincerely,\nIstern rosta\nT. Glenn Foster\nChief, Regulatory Review and Reinvention Branch\nStandards and Rulemaking Division\n2\n\n<<<PAGE 3>>>\n\nEdmonson\n§143.199\nEdmonson, Eileen (PHMSA)\nCaregory B Infectious Substances\nFrom:\nDavid Creighton <DavidCreighton@saftpak.com>\n14-0060\nSent:\nWednesday, March 26, 2014 3:13 PM\nTo:\nEdmonson, Eileen (PHMSA)\nSubject:\nLetter of Interpretation\nHello Eileen\nI wanted to add my appreciation for your attendance and assistance at the ABSA shipping discussion earlier this\nmonth. There was an item from the meeting that I wanted to discuss with you. In the packaging section the question\nwas raised about mixing and matching components of Category B packages from different manufacturers, or adding or\nremoving components that are not part of the approved package design as outlined in the closure instructions. As a\npackaging manufacturer, we have come across a number of shippers who do not understand the importance of\nfollowing the closure instructions, especially in relation to drop test requirement. As such I was wondering if it is\npossible to receive a PHMSA letter of interpretation on the following questions.\nIs it possible to alter (mix for different manufacturers, add or remove) components of a Category B package from its\ntested design without performing a new drop test? If the shipper alters the components from the package design, is the\nshipper responsible to ensure the altered package design is capable of passing the drop test as outlined in 173.199 (a)\n(4) and is the shipper responsible to create new closure instructions as outlined in 173.199 (a) (10)?\nThank you\nDavid Creighton\nRegulatory and Training\na rating 25 las\nManager\n1988-2013\nSaf-T-Pak Inc.\nPhone: 780-733-7702\nSAFTPAR\nFax:\n780-486-0235\nA Cantel Medical Company\nwww.saftpak.com\nor Quality Serie\nCelebrating 25 years of Trust, Respect & Quality\nFollow us using\nThis communication (including any attachments) is intended only for use by the addressee(s) named herein and may\ncontain legally privileged or confidential information. If the reader of the message is not the intended recipient or an\nauthorized representative of the intended recipient, you are hereby notified that any dissemination or distribution of\nthis communication (or attachments) is strictly prohibited. If you have received this communication in error, please\nnotify us immediately by e-mail and permanently delete the communication and any attachments from your system.","truncated":false,"body_characters":5467}