{"operation":"document","citation":"15-0090","title":"Inova Diagnostics — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2015-08-17","effective_on":null,"summary":"15-0090 response to Inova Diagnostics concerning 178.601.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-15-0090.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-15-0090.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-15-0090","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2015/150090.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nof Transportation\n1200 New Jersey Avenue SE\nWashington. DC 20590\nMaterials Safety\nPipeline and Hazardous\nAdministration\nAllison E. Fowler\nEH & S Manager, BSO, CHO\nInova Diagnostics\n9900 Old Grove Road\nSan Diego, CA 92131\nAUG 1 7 2015\nRef. No. 15-0090\nDear Ms. Fowler:\nThis responds to your May 6, 2015 request for clarification on the Hazardous Materials\nis compliant with § 178.601(g)(1), Variation 1.\nRegulations (HMR; 49 CFR Parts 171-180). Specifically, you ask if the following scenario\nYou state that you had a certification for a low density polyethylene (LDPE) plastic inner\npackaging/bottle that passed the testing/certification criteria and proved capability. This\ncertification has since expired. You have a current certification that tested a high density\npolyethylene (HDPE) plastic (re: inner packaging bottle type), and it references HDPE,\nLDPE and PPCO on the certification under materials/bottle type. You ask if you comply\nwith § 178.601(g)(1), Variation 1, using an LDPE bottle type for inner packaging under the\ncurrent certification.\nYou believe that because the previous certification proved capability of LDPE and the\ncurrent certification for HDPE proves capability, an equivalent level of performance is\nmaintained on the basis of: (1) the inner packagings are of equivalent size/volume; (2) the\ninner packagings are of similar design to the tested inner packagings (i.e., shape-round);\nand (3) the material of construction of the inner packagings (re: plastic) offers resistance to\nimpact and stacking forces equal to or greater than that of the originally tested inner\npackaging. Therefore, you believe the LDPE plastic inner packaging included under the\nwith § 178.601(g)(1), Variation 1.\nHDPE certification may be used without further testing of the packaging in accordance\nYour understanding is correct. Use of the LDPE plastic inner packagings complies with\nrequirements in § 178.601(g)(1), Variation 1. Provided the inner packagings are of similar\ndesign (i.e., shape) and the material of construction offers the same or greater impact\nresistance than that of the originally tested inner packaging, further testing of a tested\ndesign type is not necessary and the LDPE inner packagings may be used. Moreover,\nprovided an equivalent level of performance can be ascertained, you may use the LDPE\ninner packagings instead of the HDPE inner packagings under Variation 1.\n\n<<<PAGE 2>>>\n\nI hope this answers your inquiry. If you need additional assistance, please contact this\nOffice at 202-366-8553.\nSincerely,\nNot Pite\nDirk Der Kinderen\nActing Chief, Standards Development Branch\nStandards and Rulemaking Division\n\n<<<PAGE 3>>>\n\nBoothe\n$178.601(1)\nDodd, Alice (PHMSA)\napplicability\n15-0090\nFrom:\nSent:\nGeller, Shelby CTR (PHMSA)\nTo:\nWednesday, May 06, 2015 3:57 PM\nSubject:\nHazmat Interps\nAttachments:\nFW: Inova Diagnostics, Interpretive Letter (HMR; 49 CFR Parts 178.601(1), Variation 1\nLDPE_VS_HDPE.Intpretative.Letter_05.05.15_Final.pdf\nHi Shante and Alice,\nAttached is a request for a formal letter of interpretation. Please let me know if you need any more information.\nThanks,\nShelby\nFrom: afowler@inovadx.com [mailto:afowler@inovadx.com]\nSent: Wednesday, May 06, 2015 3:28 PM\nTo: INFOCNTR (PHMSA)\nCc: Karen.Yoneda@faa.gov; Gary Lindsey - Dangerous Goods; steve@normaninternational.com;\nsgustafson@inovadx.com; bwaddell@sd.inovadx.com; elorusso@ilww.com; eaustin@inovadx.com\nSubject: Inova Diagnostics, Interpretive Letter (HMR; 49 CFR Parts 178.601(1), Variation 1\nDear Department of Transportation (DOT) information center,\nI am Allison Fowler, EH&S Manager with Inova Diagnostics, Inc.\nPlease see attached Interpretative Letter, we are seeking clarification on HMR; 49 CFR Parts 178.601(1), Variation 1.\nIf you have questions or concerns with the letter as written, please feel free to contact me.\nThank you so much for your time and help. We look forward to hearing back from you.\nAll the best.\nBest regards,\nAllison E. Fowler\nEH&S Manager, BSO, CHO\nallison@inovadx.com\nInova Diagnostics\n9900 Old Grove Road\nCall +1-358-449-3212 Tel. +1-858-586-9900\nSan Diego, CA 92131\nExt. 1422\ninovadx.com\n\n<<<PAGE 4>>>\n\nInova\nDiagnostics\nTo:\n: Worfen Company\ninfocntr@dot.gov\nTo whom it may concern,\nMay 05, 2015\nHazardous Materials Regulations (HMR; 49 CFR Parts 171-180).\nThis letter is written to request written clarification on 4GV non-bulk combination packaging under the\nWe are asking for your help interpreting § 178.601(g)(1), Variation 1.\nVS. high density polyethylene (HDPE).\nThis question specifically regards inner packagings of plastic mediums: low density polyethylene (LDPE)\ncriteria and we proved capability. This certification has now expired (re: JOB NO. 12211U, Norman\nWe have a certification in which we tested LDPE for inner packaging/bottle plastic type; LDPE passed the\nInternational, March 14, 2012).\nHDPE, LDPE and PPCO on the certification under materials/bottle type (Job No. 14526U, Norman\nWe have a current certification that tested HDPE plastic (re: inner packaging bottle type), it references\nInternational, September 18, 2014).\nQuestion:\nAre we compliant using an LDPE bottle type for inner packaging under this certification?\nand an equivalent level of performance is maintained, we believe:\nBecause the previous certification proved capability of LDPE, and the HDPE bottles are of similar design\n• the inner packagings are of equivalent size/volume.\nthe material of construction of the inner packagings (re: plastic) offers resistance to impact and\nthe inner packagings are of similar design to the tested inner packagings (i.e. shaperound).\nstacking forces equal to or greater than that of the originally tested inner packaging.\ncertification per 49 CFR § 178.601(g)(1), Variation 1.\nTherefore, we believe that LDPE has been proven to be equivalent to HDPE and is compliant under the\nPlease advise?\nSincerely,\n@ 05/05/15\nEH&S Manager, BSO, CHO\nInova Diagnostics\n9900 Old Grove Road\nallison@inovadk.com\nSan Dieco CA 92131\nCell +1-858 449-3212 Tel +1 858-586-9900\nEx: 1422\n...-","truncated":false,"body_characters":6066}