{"operation":"document","citation":"15-0092","title":"Inmark Packaging — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2016-03-02","effective_on":null,"summary":"15-0092 response to Inmark Packaging concerning 173.199.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-15-0092.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-15-0092.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-15-0092","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2015/150092.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nof Transportation\n1200 New Jersey Avenue, SE\nWashington, D.C. 20590\nPipeline and Hazardous\nMaterials Safety\nAdministration\nMAR 022016\nJay Johnson, DGSA\nInmark Packaging\nRegulatory Compliance Manager\n675 Hartman Road, Suite 100\nAustell, GA 30168\nRef. No.: 15-0092\nDear Mr. Johnson:\nThis letter is in response to your e-mail and attached letter requesting the applicability of the\nHazardous Materials Regulations (HMR; 49 CFR Parts 171-180) to closure instructions for\nCategory B infectious substance packagings. Specifically, you ask if the closure instructions\non filling and closing a Category B packaging that are prescribed in § 173.199(a)(10) differ\nfrom the closure instruction requirements prescribed in § 178.2(c).\nWhile the packaging closure instructions prescribed in §§ 173.199(a)(10) and 178.2(c) use\nsimilar language, the instructions differ in that those prescribed in § 178.2(c) apply to\nhazardous materials subject to the requirements of 49 CFR Subtitle B, Chapter I, Subchapter\nC. The HMR excepts Category B infectious substances prepared and offered for\ntransportation in conformance with the requirements prescribed in § 173.199 from having to\nconform to the remainder of 49 CFR Subchapter C, except those requirements specifically\nprescribed in § 173.199 (see § 173.199(a)). Therefore, the packaging closure instructions\nprescribed in § 173.199(a)(10) apply only to Category B infectious substances.\nYou also refer to a letter the Pipeline and Hazardous Materials Safety Administration\n(PHMSA) issued under Reference No. 14-0060 that stated the HMR does not require closure\ninstructions for Category B infectious substances that conform to § 173.199. For clarification,\nthe HMR does require closure instructions under § 173.199(a)(10) for Category B infectious\nsubstances but does not require these materials to conform to the closure instructions\nprescribed in § 178.2(c).\nI hope this information is helpful. Please contact us if we can be of further assistance.\nSincerely,\nern taster\nT. Glenn Foster\nChief, Regulatory Review and Reinvention Branch\nStandards and Rulemaking Division\n\n<<<PAGE 2>>>\n\nEdmonson\n•\n5173.199\nB Irfectious sab\nDodd, Alice (PHMSA)\nFrom:\nINFOCNTR (PHMSA)\nSent:\nTo:\nTuesday, May 05, 2015 4:22 PM\nHazmat Interps\nSubject:\nFW: Question regarding 173.199\nAttachments:\nInterp Request on 173.199.pdf\nDear Shante & Alice, please assign to Eileen Edmonson.\nThanks,\nSent: Tuesday May 5, 2015 9:45 AM\nFrom: Jay Johnson [mailto:jayj@inmarkinc.com]\nTo: PHMSA HM InfoCenter\nSubject: Question regarding 173.199\nPlease see attached document for a request for a formal letter of interpretation of 49 CFR 173.199.\nKind Regards,\nJay Johnson, DGSA\n675 Hartman Road, Suite 100\nRegulatory Compliance Manager\nAustell GA 30168\nConfidentiality Notice:\nand its disclosure is strictly limited to the recipient intended by the sender of this message. This transmission, and any attachments, may contain\nThis communication constitutes an electronic communication within the meaning of the Electronic Communications Privacy Act, 18 U.S.C. Section 2510,\nconfidential information. If you are not the intended recipient, any disclosure, copying, distribution or use of any of the information contained in or\ntransmission and its attachments without reading or saving in any manner.\nattached to this transmission is STRICTLY PROHIBITED. Please contact us immediately by return e-mail or at +1-770-373-3300 and destroy the original\n1\n\n<<<PAGE 3>>>\n\nMr. Charles E. Betts\nU.S. DOT/PHMSA (PHH-10)\nDirector, Standards and Rulemaking Division\nWashington, DC 20590\n1200 New Jersey Avenue, SE East Building, 2nd Floor\nDear PHMSA:\nIn your recent interpretation (Reference No. 14-0060) you stated that 173.199 do not require closure instructions.\nstandard packagings that comply with the requirements in 49 CFR Part 178 (see § 178.2(c)(1) (ii) (B)). The\nA3. The answer is no. The HMR requires packaging closure instructions for DOT specification and UN\nHMR does not require closure instructions for packagings that comply with § 173.199.\ntransport a Category B infectious\" differ from the closure requirements found in § 178.2(c)?\nHow do the requirements in § 173.199(a)(10) for \"Clear instructions on filling and closing a packaging used to\ninfectious substance must be provided by the packaging manufacturer and subsequent distributors to the\n-§173.199(a)(10) Clear instructions on filling and closing a packaging used to transport a Category B\nconsignor or person who prepares the package to enable the package to be correctly prepared for\nsubsequent distributors for at least one year from the date of issuance, and made available for inspection\ntransport. A copy or electronic image of these instructions must be retained by the manufacturer and\nby a Federal or state government representative upon request. Packagings must be filled and closed in\naccordance with the information provided by the packaging manufacturer or subsequent distributor.\n-§178.2(c) (1) (i)(B) With information specifying the type(s) and dimensions of the closures, including\nthe applicable performance tests. This information must include any procedures to be followed, including\ngaskets and any other components needed to ensure that the packaging is capable of successfully passing\nclosure instructions for inner packagings and receptacles, to effectively assemble and close the packaging\nBELE\nfor the purpose of preventing leakage in transportation. Closure instructions must provide for a consistent\nit was tested. For packagings sold or represented as being in conformance with the requirements of this\nand repeatable means of closure that is sufficient to ensure the packaging is closed in the same manner as\nsubchapter applicable to transportation by aircraft, this information must include relevant guidance to\nensure that the packaging, as prepared for transportation, will withstand the pressure differential\nrequirements in $173.27 of this subchapter.\n-§178.2(c)(1)(iii) Make copies of all written notifications available for inspection by a representative of the\n-§178.2(c)(1)(ii) Retain copies of each written notification for at least one year from date of issuance; and\nDepartment.\nKind Regards,\nJay Johnson, DGSA | Regulatory Compliance Manager\nAustell GA 30168\n675 Hartman Road, Suite 100\n770-373-3300 770-373-3356 770-377-0205 770-373-3357 jayi@inmarkpackaging.com\nSAFA PAK™\nInmark*\nAN InmarkS COMPANY\nĐGS\nEXAKT PAK®\nDO SUPPLIES\nAN INMARK BRAND\n\n<<<PAGE 4>>>\n\nFollow us at:\nt in\nVisit our website or InmarkPackaging.com to learn more about our products and services.\nPlease consider the environment before printing this e-mail.\nConfidentiality Notice:\nU.S.C. Section 2510, and its disclosure is strictly limited to the recipient intended by the sender of this message. This transmission,\nThis communication constitutes an electronic communication within the meaning of the Electronic Communications Privacy Act, 18\nor use of any of the information contained in or attached to this transmission is STRICTLY PROHIBITED. Please contact us\nand any attachments, may contain confidential information. If you are not the intended recipient, any disclosure, copying, distribution\nsaving in any manner.\nimmediately by return e-mail or at +1-770-373-3300 and destroy the original transmission and its attachments without reading or","truncated":false,"body_characters":7348}