{"operation":"document","citation":"98-0547","title":"Partners in Compliance, Inc. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"1998-01-12","effective_on":null,"summary":"98-0547 response to Partners in Compliance, Inc. concerning 173.196.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-98-0547.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-98-0547.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-98-0547","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/1998/980547.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nof Transportation\n400 Seventh Street, S.W.\nSpecial Programs\nResearch and\nWashington, D.C. 20590\nAdministration\nJAN 1 2 1988\nMr. Jay Johnson\nPartners in Compliance, Inc.\n1\n100 Dominion Drive Suite 102\nMorrisville, NC 27560\nDear Mr. Johnson:\nThis is in response to your letter of July 28, 1997, and August 11, 1997 telephone\nconversation with Ms. Eileen Edmonson of my staff asking if multiple primary packagings of\na Division 6.2 material must be separated by a material that is both cushioning and capable of\nabsorbing their entire contents.\nThe answer is no. Section 173.196(a)(1)(iii) requires that multiple primary packagings of a\nDivision 6.2 material be wrapped individually by a material, absorbent or non-absorbent,\nsufficient to ensure contact between the receptacles is prevented and the packaging complies\nwith the performance tests in § 178.609. However, this section does require that material\nsufficient to absorb the entire liquid contents of the inner packagings be placed between the\nprimary and secondary packagings.\n:\nYou stated the current design for your packaging has each primary receptacle surrounded with\nan absorbent foam that prevents contact between the receptacles. You questioned whether\nseparating these packagings with fiberboard or plastic dividers and placing an absorbent strip\nat the bottom of the secondary packaging would fulfill the requirements in § 173.196.\nProvided the packaging meets the performance tests required in § 178.609, this configuration\nwould be acceptable. However, please be aware that these performance tests require the\npackaging to be dropped on its bottom, top, sides, and corner, cold-conditioned and immersed\nin water with no leakage from the primary receptacle. Placing the absorbent material only at\n:\nthe bottom of the packaging may prove insufficient to meet these criteria.\nThank you for inquiry. If we can assist you further, please let us know.\nSincerely,\n:\nit Genifer Kar\nHattie L. Mitchell, Chief\nExemptions and Regulations Terminations\nOffice of Hazardous Materials Standards\n\n<<<PAGE 2>>>\n\n• •\nU.S.Department\nof Transportation\n-on seven SC 559\nResearch and\nAdministration\nSpecial Programs\nAPR\n9 IC93\nMr. Barry Sibley\nEnvironmental Packaging Systems Ltd.\n1 Research Drive\nDartmouth, N.S.\nCanada B2Y 4M9\nDear Mr. Sibley:\nThis is in response to your February 18 telefax to Mr. James Jones, and\npackaging you described for the shipment of infectious substances and\nadditional information dated March 3, 1993, concerning the suitability of the\ndiagnostic specimens.\npackaging and a fiberboard outer packaging.\nThe packaging you described consists of a plastic inner\nNew packaging requirements for infectious substances are not mandatory within\nthe United States until January 1, 1994.\nyour packaging does not meet the requirements for packagings for infectious\nFrom the information you presented,\nEdition of the United Nations Recommendations on the Transport of Dangerous\nsubstances specified in 49 CFR 173.196 and 178.609 and the Seventh Revised\nGoods for the following reasons:\nFirst, paragraph 173.196(a) (11) (and UN 6.13. (a)(11I)) requires that absorbent\nmaterial be placed between the primary and secondary receptacles, enough to\nabsorb the entire liquid contents of all primary receptacles. The absorbency\ntest result noted in your test report from Nova Scotia Research Foundation\ncorporation shows an absorbency of 50 ml. One of the packages tested\ncontained 14 \"Vacutainers\" of 5 ml capacity each. The 70 ml liquid contents\nis more than the absorbent material is capable of absorbing.\nSecond, the testing requirements of 49 CFR 178.609 (and UN 6.14.3 and 6.14.4)\nfor a plastic inner packaging in a fiberboard outer packaging include two drop\ntests.\nFor the first drop test, the packaging (assembled as for shipment)\n50+/-2 percent relative humidity. There is no indication in the test report\nthat the immersion was conducted. For the second drop, the packaging must be\ncondítioned in an atmosphere of -18°C or less for at least 24 hours. There is\nno indication in the test report that this cold conditioning was performed.\n:\nA packaging used to transport infectious substances after January 1, 1994 must\nThere is an exception from these requirements in paragraph 173.196 (h) for\ncomply with all other applicable requirements of 49 CFR 173.196 and Part 178.\ncertain diagnostic specimens.\n\n<<<PAGE 3>>>\n\nis stated above, the requirements for infectious substances contained in\n§$ 173.196 and 178.609 are not mandatory until January 1, 1994. Voluntary\ncompliance with the new requirements is currently authorized.\nJanuary 1, 1994, packagings for infectious substances which are \"etiologic\nSeptember 30, 1990) must meet the requirements of 49 CFR 173.387 (of the same\nagents, \" as defined in 49 CFR 173.386 (of the of the regulations in effect on\npackaging meets those requirements.\nFrom the information presented in your letter, it appears that your\nYou also asked whether your company would qualify for an \"M\" number to place\non the outer packaging.\nUN packaging, part of the marking is an indication of the country authorizing\nIf your packaging will be certified and marked as a\nallocation of the mark.\nmanufactured and marked in the United States. The \"M\" numbers issued by our\nThe letters \"USA\" may only be marked on a packaging\nOffice of Hazardous Materials Exemptions and Approvals are only issued for\npackagings manufactured and marked in the United States.\nSincerely,\n-...\nI la 1 7i Mazzill\nDirector\nedward 1.\nOffice of Hazardous\nMaterials Standards\n\n<<<PAGE 4>>>\n\n:\nEdmansas\nPARTNERS IN COMPLIANCE. INC.\nFile: 173.19610)01) (ind\n100 Dominion Drive, Suite 102, Morrisville, NC 27560\nPhone: 919-468-0333\nFaX: 919-408-0311\nSC: 300,\nJuly 28, 1997\nEdward T. Mazzullo\nDirector, Office of Hazardous Materials Standards\nU.S. Department of Transportation\nResearch & Special Programs Administration\nDHM-10, Room 8100\nashington, DC 20590-000\n0 Seventh Street, ST\nSUBJECT: Request for Interpretation\n49 CFR, Section 173.196(a)(1)(iüi) an absorbent material must be placed between the primary\nreceptacle and the secondary packaging. If multiple-primary receptacles are placed in a single\nsecondary packaging they must be wrapped individually to ensure that contact between them is\nprevented. The absorbent material, such as cotton wool, must be sufficient to absorb the entire\ncontents of all primary receptacles.\nPartners In Compliance, Inc. is committed to compliance with the regulations governing the\ntransportation of hazardous materials. We are currently developing a packaging system for the\ntransport of infectious substances. Each individual primary receptacle will be surrounded in an\nabsorbent foam rack that protects and prevents contact.\nBased on a conversation with Helen Engrum of the DOT/RSPA and our understanding of the\nregulations, multiple primary receptacles placed in a single secondary packaging must be\nindividually surrounded by material that is both absorbent and cushioning to prevent breakage or\nleakage and control movement. We feel that the use of corrugate or plastic dividers to separate\nprimary receptacles with an absorbent strip at the bottom of the secondary packaging does not\nmeet the requirements for individual wrapping stated in the regulations. Please respond with your\nconcurrence/non-concurrence.\nSincerely,\nPartners In Compliance, Inc.\n\n<<<PAGE 5>>>\n\nTELEPHONIC CONVERSATION RECORD\nSpecialist Receiving Call: Eileen Edmonson\nROUTING\nDate of Call: 8/11/97\nSYMBOL INT\nPerson (s) Contacted: Mr. Jay Johnson\nTheir Organization: Partners in Compliance, Inc\nDate of Incoming Letter: 7/28/97\nwords): Mr. Johnson is designing an infectious\nSpecific Subject (including section #'s and key\nsubstance packaging.\n173.196 (a) (1) (lii) was instructing him to wrap\nHe wanted to know if §\neach primary packaging with an absorbent\nmaterial that would simultaneously separate each\nprimary packaging to prevent damage and absorb\nits entire contents.\nletter\nSummary: On August 7, 1997, I faxed Mr. Johnson a related\n4/9/93) we did on absorbent material for infectious substance\nEnvironmental Packaging Systems Ltd.,\npackagings as an example of the type of information we needed\nJohnson called me on August 11 and stated he has only begun to\nabout his packaging to provide him with a response.\ndesign his packaging and, as a result, has no drawing or test\nresults to send me. I told him that the dividers between the\nprimary receptacles did not have to meet the absorbent\ncriteria in §\nwished to design it that way. I\nprevent the inner packagings from being damaged. I told him\nhowever he designed the packaging, it would have to pass the\nperformance tests located in § 178.609. He requested this\nresponse in writing.\nComments for Further Action: I drafted the response on August\n11, 1997, and forwarded it for review.\nspecialist signature: Gillen & Edmanen\nDate:\n8/11/97\n\n<<<PAGE 6>>>\n\n•\nFFICE OF HAZARDOUS MATERIALS STANDARD\n'ORRESPONDENCE TRACKING SHEEL\nDATE\nCOMPANY\nSPECIALIST\n07/28/97\nPARTNERS IN COMPLIANCE INC\n/FROM: JAY JOHNSON\nEDMONSON\nRECEIVED:\nDUE:\nASSIGNED: 08/07/97\nSUBJECT\n09/04/97\n173.196\nSIGNED:\nCOMMENTS:\nSUMMARY:\nCOMPLEXITY:\nH\nM\nL\nSIGNATURE:\nDRAFTS:","truncated":false,"body_characters":9194}