{"operation":"document","citation":"15-0154","title":"Inmark Packaging, Inc. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2016-02-01","effective_on":null,"summary":"15-0154 response to Inmark Packaging, Inc. concerning 173.199, 178.609.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-15-0154.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-15-0154.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-15-0154","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2016/150154.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nof Transportation\n1200 New Jersey Avenue SE\nWashington. DC 20590\nPipeline and Hazardous\nAdministration\nMaterials Safety\nFEB 01. 2015\nMr. Jay Johnson\nRegulatory Compliance Manager\nInmark Packaging, Inc.\n675 Hartman Road, Suite 100\nAustell, GA 30168\nReference No. 15-0154\nDear Mr. Johnson:\nThis is in response to your July 27, 2015 email and subsequent telephone conversation with a\nmember of my staff concerning packaging requirements for Category B infectious substances\ncontained in the Hazardous Materials Regulations (HMR: 49 CFR Parts 171-180).\nSpecifically, you ask whether a Category B packaging is required to meet the conditions\nspecified in §S 178.609(e) and 178.609(f) for water spray and cold conditioning, respectively,\nbefore subjecting the packaging to the drop test in § 178.609(d).\nAs specified in § 173.199(a)(4), a Category B packaging must be capable of successfully\npassing the drop test in § 178.609(d) at a drop height of at least 1.2 meters (3.9 feet) but is not\nrequired to be tested using this method. Further, as stated in the preamble to a final rule\nissued under Docket No. PHMSA-2004-16895 (71 FR 32244), a § 173.199 packaging need\nnot be capable of passing a puncture or other performance tests. Therefore, the HMR do not\nrequire that a Category B infectious substance packaging be subjected to the conditions\nprescribed in §§ 178.609(e) and 178.609(f) in preparation for the drop test prescribed in\n§ 178.609(d).\nI hope this information is helpful. Please contact this office if we can be of further assistance.\nSincerely,\nDone A. Pad\nDuane A. Pfund\nInternational Standards Coordinator\nStandards and Rulemaking Division\n\n<<<PAGE 2>>>\n\n\".\nSuchat\n$/73.199\nDodd, Alice (PHMSA)\nCatagory В сприном\nsubstances\nFrom:\nFoster, Glenn (PHMSA)\n15-0154\nSent:\nTuesday, July 28, 2015 8:33 AM\nTo:\nDodd, Alice (PHMSA); Goodall, Shante CTR (PHMSA)\nSubject:\nQuestion about Category B Infectious Packaging\nAlice and Shante,\nPlease check in the email below as a request for letter of interpretation.\nThanks,\nGlenn\nFrom: Foster, Glenn (PHMSA)\nSent: Tuesday, July 28, 2015 7:40 AM\nTo: 'Jay Johnson'\nCc: Betts, Charles (PHMSA); Supko, Ben (PHMSA)\nSubject: RE: Question about Category B Infectious Packaging\nHello Jay,\nYour inquiry below will be logged in as a request for Interpretation and responded accordingly.\nThanks,\nGlenn\nFrom: Jay Johnson [mailto:jayj@inmarkinc.com]\nSent: Monday, July 27, 2015 4:42 PM\nTo: Foster, Glenn (PHMSA)\nCc: Betts, Charles (PHMSA); Supko, Ben (PHMSA)\nSubject: RE: Question about Category B Infectious Packaging\nHello Glenn,\nWhile you are working on this, I have another question on 173.199 package performance capability.\nDoes Category B packaging that is being dropped according to 178.609(d) subject to the cold conditioning and water\nspray conditioning as defined in 178.609(b) and 178.609(c)?\nKind Regards,\nJay Johnson, DGSA | Regulatory Compliance Manager\nSAF\\PAK™\nInmark i\nAN Inmarkyl COMPANY\n1\n\n<<<PAGE 3>>>\n\nE\nEXAKT-PAK®\nDO SUPPLIES\nAN INMARK BRAND\n675 Hartman Road, Suite 100 Austell GA 30168\n0 770-373-3300 | d 770-373-3356 | m770-377-0205 | f770-373-3357 | e jayi@inmarkpackaging.com\nFollow us at:\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:\ntransmission and its attachments without reading or saving in any manner.\nFrom: Glenn.Foster@dot.gov [mailto:Glenn.Foster@dot.gov]\nTo: Jay Johnson\nSent: Wednesday, June 24, 2015 11:48 AM\nCc: charles.betts@dot.gov; Ben. Supko@dot.gov\nSubject: RE: Question about Category B Infectious Packaging\nJay,\nIn the meantime, here is a PDF of the NPRM under HM-218 \"Miscellaneous Amendments\" where the revision was\nproposed. I will have the final rule forwarded to you when it is published, as well.\nThanks,\nGlenn\nFrom: Foster, Glenn (PHMSA)\nTo: 'Jay Johnson'\nSent: Wednesday, June 24, 2015 10:56 AM\nCc: Betts, Charles (PHMSA); Supko, Ben (PHMSA)\nSubject: FW: Question about Category B Infectious Packaging\nHello Jay,\nThanks for the follow-up. Our plan is to include this revision in an upcoming rulemaking. We will send you a\nnotification/link to the rule when it is published.\nThanks,\nGlenn\nFrom: Jay Johnson [mailto:jayj@inmarkinc.com]\nSent: Wednesday, June 24, 2015 6:21 AM\nTo: Betts, Charles (PHMSA); Supko, Ben (PHMSA)\nSubject: FW: Question about Category B Infectious Packaging\nHello Ben and Charles,\n2\n\n<<<PAGE 4>>>\n\nI am curious how things are progressing with two questions | asked Del Billings back in 2011\nHas there been any changes regarding this topic?\nThanks\nJay Johson\nInmark\nFrom: Jay Johnson\nTo: 'delmer.billings@dot.gov'\nSent: Wednesday, August 03, 2011 12:21 PM\nSubject: Question about Category B Infectious Packaging\nHello Del,\nI have two questions about the package testing for Biological Substance, Category B and I hope you\ncan help me with this. Currently §§173.199(a)(4) states that packages must be capable of\nsuccessfully passing the drop tests in §§178.609(d) and (h) of this subchapter.\n173.199(a)(4) The completed package must be designed, constructed, maintained, filled, its contents\nlimited, and closed so that under conditions normally encountered in transportation, including removal\nfrom a pallet or overpack for subsequent handling, there will be no release of hazardous material into\nthe environment. Package effectiveness must not be substantially reduced for minimum and\nmaximum temperatures, changes in humidity and pressure, and shocks, loadings and vibrations\nnormally encountered during transportation. The packaging must be capable of successfully passing\nthe drop tests in §§178.609(d) and (h) of this subchapter at a drop height of at least 1.2 meters (3.9\nfeet). Following the drop tests, there must be no leakage from the primary receptacle, which must\nremain protected by absorbent material, when required, in the secondary packaging. At least one\nsurface of the outer packaging must have a minimum dimension of 100mm by 100 mm (3.9 inches).\nPHMSA clarified this requirements in an interpretation (PHMSA Interpretation #07-0018 ) that:\nA packaging used to transport a Category B infectious substance must be capable of passing the\ndrop test prescribed in § 178.609(d). The packaging is not required to also be capable of passing the\nsteel rod impact test in § 178.609(h). We will correct this error in a future rulemaking.\nQuestion 1: Do you know when the rulemaking to correct this error is going to occur?\nQuestion 2: When conduction the drop testing in §§178.609(d) to establish if the packages are\ncapable of passing the drop test, do the samples have to be conditioned as described in the\nrequirements of §$178.609(e), §§178.609(f), and §$178.609(g)?\n§§178.609(e) The samples must be subjected to a water spray to simulate exposure to rainfall of\napproximately 50 mm (2 inches) per hour for at\nleast one hour. They must then be subjected to the test described in paragraph (d) of this section.\n§§178.609(f) The sample must be conditioned in an atmosphere of -18 [deg]C (0 [deg]F) or less for a\nperiod of at least 24 hours and within 15 minutes\nof removal from that atmosphere be subjected to the test described in paragraph (d) of this section.\nWhere the sample contains dry ice, the\nconditioning period may be reduced to 4 hours.\n3\n\n<<<PAGE 5>>>\n\n§$178.609(g) Where packaging is intended to contain dry ice, a test additional to that specified in\nparagraph (d) or (e) or (f) of this\nsection must be carried out. One sample must be stored so that all the dry ice dissipates and then be\nsubjected to the test described in\nparagraph (d) of this section.\nThanks for your clarification on the matter.\nBest regards,\nJay Johnson DGSA, Regulatory Compliance Manager | Inmark | 675 Hartman Road, Suite 100, Austell, GA 30168|\nwww.inmarkinc.com\nmain: 770.373.3300 | direct: 770.373.3356| direct fax: 770.373.3357| cellular: 770.377.0205 jayi@inmarkinc.com |\nThis communication constitutes an electronic communication within the meaning of the Electronic Communications\nConfidentiality Notice:\nPrivacy Act, 18 U.S.C. Section 2510, and its disclosure is strictly limited to the recipient intended by the sender of this\nrecipient, any disclosure, copying, distribution or use of any of the information contained in or attached to this transmission\nmessage. This transmission, and any attachments, may contain confidential information. If you are not the intended\nis STRICTLY PROHIBITED. Please contact us immediately by return e-mail or at +1-770-373-3300 and destroy the\noriginal transmission and its attachments without reading or saving in any manner.","truncated":false,"body_characters":8638}