{"operation":"document","citation":"11-0227","title":"Inmark — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2011-09-21","effective_on":null,"summary":"11-0227 response to Inmark concerning 173.199, 178.609.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-11-0227.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-11-0227.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-11-0227","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretations/2011/110227.pdf","body":"<<<PAGE 1>>>\n\n1200 New Jersey Ave., S.E.\nU.S. Department Washington, DC 20590\nof Transportation\nPipeline and Hazardous\nMaterials Safety\nAdministration\nSEP 2 1 2011\nJay Johnson, DGSA\nRegulatory Compliance Manager\nInmark\n675 Hartman Road, Suite 100\nAustell, GA 30168\nReference No. 11-0227\nDear Mr. Johnson:\nThis is in response to your August 3,2011, and September 1,2011 e-mails to Mr. Dehner\nBillings, Senior Regulatory Advisor, Standards and Rulemaking Division, Pipeline and\nHazardous Materials Safety Administration (PHMSA). He directed your e-mail to my branch for\nresponse. A member of my staff responded to you informally bye-mail on September 19, 2011.\nThis is our official response to your inquiry. You ask when PHMSA plans to revise\n§ 173.199(a)( 4) to remove the steel rod puncture test from the requirements for Category B\ninfectious substance packagings. We cannot provide you with a specific time frame, but can tell\nyou that this revision is currently under consideration for inclusion in a future rulemaking.\nYou also ask if a Category B, Division 6.2 (infectious substance) must be capable of surviving\nthe conditioning requirements prescribed in §§ 1 78.609(e) (water spray), 178.609(t) (coldconditioned),\nand I 78.609(g) (dry ice dissipation) to demonstrate that it is capable ofpassing the\ndrop test in § 178.609(d). The answer is no. See page 32247, first paragraph, ofthe preamble of\nthe final rule PHMSA issued under Docket No. PHMSA-2004-16895 (HM-226A; 71 FR 32244;\nhttp://edocket.access.gpo.gov/2006/pdf/06-4992.pdf), where PHMSA stated a § 173.199\npackaging need not be capable ofpassing a puncture or other performance tests.\nI hope this satisfies your request.\nSincerely,\nrY~71-~~\nT. Glenn Foster\nChief, Regulatory Review and Reinvention\nStandards and Rulemaking Division\n\n<<<PAGE 2>>>\n\nEdmonson, Ei leen\nSubject: FW: Question about Category B Infectious Packaging -X;tf'~~hI)UJ 5 tdas tan~·\n11-02/1-7\nFrom: Jay Johnson [mailto:jayj@inmarkinc.com]\nSent: Thursday, September 01, 2011 9:40 AM\nTo: Billings, Delmer (PHMSA)\nSubject: RE: Question about Category B Infectious Packaging\nGood Morning Del,\ntesting?\nThanks\nI was wondering if you had had a chance to look at the two questions I had sent you concerning UN3373 package\nJay Johnson DGSA, Regulatory Compliance Manager Iinmark 1 675 Hartman Road, Suite 100, Austell, GA 301681\nmain: 770.373.3300 1 direct: 770.373.33561 direct fax: 770.373.33571 cellular: 770.377.0205 jayj@inmarkinc.com I\nwww.inmarkinc.com .\nConfidentiality Notice:\nThis communication constitutes an electronic communication within the meaning of the Electronic Communications\nPrivacy Act, 18 U.S.C. Section 2510, and its disclosure is strictly limited to the recipient intended by the sender of this\nmessage. This transmission, and any attachments, may contain confidential information. If you are not the intended\nreCipient, any disclosure, copying, distribution or use of any of the information contained in or attached to this transmission\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.\n-----~--------.\nFrom: Jay Johnson\nSent: Wednesday, August 03, 2011 12:21 PM\nTo: 'delmer,billings@dot.gov'\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 ofhazardous 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 §§17B.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 100 mm by 100 mm (3.9 inches).\nPHMSA clarified this requirements in an interpretation (PHIVISA Interpretation #07-0018) that:\n1\n\n<<<PAGE 3>>>\n\nA packaging used to transport a Category B infectious substance must be capable ofpassing the\ndrop test prescribed in § 178.609(d). The packaging is not required to also be capable ofpassing 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) ofthis 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\nofremoval from that atmosphere be subjected to the test described in paragraph (d) ofthis section.\nWhere the sample contains dry ice, the\nconditioning period may be reduced to 4 hours.\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 Iinmark 1675 Hartman Road, Suite 100, Austell, GA 301681\nmain: 770.373.3300 1 direct: 770.373.33561 direct fax: 770.373.33571 cellular: 770.377:0205 jaYi@inmarkinc.com I\nwww.inmarkinc.com\nConfidentiality Notice:\nThis communication constitutes an electronic communication within the meaning of the Electronic Communications\nPrivacy Act, 18 U.S.C. Section 2510, and its disclosure is strictly limited to the recipient intended by the sender of this\nmessage. This transmission, and any attachments, may contain confidential information. If you are not the intended\nrecipient, any disclosure, copying, distribution or use of any of the information contained in or attached to this transmission\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.\n2","truncated":false,"body_characters":7205}