{"operation":"document","citation":"14-0153","title":"Deitrich Engineering — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2014-11-28","effective_on":null,"summary":"14-0153 response to Deitrich Engineering concerning 171.7, 173.22.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-14-0153.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-14-0153.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-14-0153","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2014/140153.pdf","body":"<<<PAGE 1>>>\n\nof Transportation\nU.S. Department\n1200 New Jersey Avenue SE\nWashington DC 20590\nSafety Administration\nPipeline and Hazardous Materials\nNOV 2 8 2014\nMr. David Dietrich\nDietrich Engineering\nP.O. Box 7\nCool, CA 95614\nRef. No.: 14-0153\nDear Mr. Dietrich:\nThis responds to your July 28, 2014 letter requesting clarification of the Hazardous Materials\nRegulations (HMR; 49 CFR Parts 171-180) applicable to a self-heating material classified as a\nDivision 4.2 spontaneously combustible material. In your letter, you state that you have a client,\nGesellschaft fuer Gefahrgut m.b.H., in Romanshorn, Switzerland, that is arranging import of a\npharmaceutical comprised of an iron-based phosphate binder for kidney disease patients. You\nfurther state that this material has been classified as \"UN3088, Self-heating solid, organic, n.o.s, 4.2,\nPG II.\" Finally, you reference 5.2.2 of Appendix 6 (Screening Procedures) of the United Nations\n(UN) Manual of Tests and Criteria which specifies that for Substances which may be liable to\nspontaneous combustion (Division 4.2):\nThe classification procedure for self-heating substances need not be applied if the results of a\nscreening test can be adequately correlated with the classification test and an appropriate safety\nmargin is applied. Examples of screening tests are:\na) The Grewer Oven test (VDI guideline 2263, part 1, 1990, Test methods for the\nDetermination of the Safety Characteristics of Dusts) with an onset temperature 80 K\nabove the reference temperature for a volume of 1 1(33.3.1.6);\nb) The Bulk Powder Screening Test (Gibson, N. Harper, D.J. Rogers, R. Evaluation of the\nfire and explosion risk in drying powders, Plant Operations Progress, 4 (3), 181-189,\n1985) with an onset temperature 60 K above the reference temperature for a volume of 1\n1(33.3.1.6).\nYour questions are paraphrased and answered below.\nQ1: You ask whether Appendix 6 is permitted to be used under the HMR?\nAl:\nThe answer is yes. As provided in § 171.7(dd) of the HMR, the \"UN Recommendations on\nthe Transport of Dangerous Goods, Model Regulations (UN Recommendations), 17th\nrevised edition, Volumes I and II (2011),\" and the \"UN Recommendations on the Transport\nrevised edition, amendment 1 (2011)\" are matters incorporated by reference in the HMR.\nof Dangerous Goods, Manual of Tests and Criteria (UN Manual of Tests and Criteria), Fifth\nTherefore, Appendix 6 to the UN Manual of Tests and Criteria is appropriate for use under\nthe HMR.\n\n<<<PAGE 2>>>\n\nQ2: You ask whether Screening Procedure 5.2.2 of Appendix 6 can be considered an alternative\n\"classification method\"?\nA2: The answer is yes, but with the following caveats. As required by § 173.22 of the HMR, it is\nthe shipper's responsibility to properly class a hazardous material. This Office generally\ndoes not perform this function. Appendix 6 to the UN Manual of Tests and Criteria provides\nthe screening procedures industry uses to identify the hazard potential of raw materials,\nreactive mixtures and intermediates, products, and by-products. The use of such procedures\nis essential to ensure safety during research and development and to ensure that new products\nand processes are as safe as possible. These procedures usually consist of a combination of a\ntheoretical appraisal and small-scale tests, and in many cases, enable an adequate hazard\nevaluation to be carried out without the need for larger scale classification tests. This\nreduces the quantity of material required, lessens any detrimental effect on the environment,\nand minimizes the amount of unnecessary testing.\nThe purpose of Appendix 6 to the UN Manual of Tests and Criteria is to present examples of\nscreening procedures. It should be used in conjunction with any screening procedures given\nin the introductions to the relevant test series. With the specified safety margin, the results\nfrom the screening procedures adequately predict when it is not necessary to perform the\nclassification test as a negative result would be obtained. They are presented for guidance\nand their use is not compulsory. Other screening procedures may be used provided that\nadequate correlation has been obtained with the classification tests on a representative range\nof substances and there is a suitable safety margin.\nIf you perform the Grewer Oven test or the Bulk Powder Screening test as provided in 5.2.2\nof Appendix 6 of the UN Manual of Tests and Criteria and the results of those screening tests\ncan be adequately correlated with the classification test and an appropriate safety margin,\nthen the classification procedure for self-heating substances need not be applied. However,\ndepending on the results of those tests, a packing group could still need to be determined or\nthe material you are classifying may meet the definition of another hazard class altogether.\nQ3: You ask whether a Special Permit is required?\nA3:\nThe answer is no.\nI trust this satisfies your inquiry. Please contact us if we can be of further assistance.\nSincerely,\nten oste\nT. Glenn Foster\nChief, Regulatory Review and Reinvention Branch\nStandards and Rulemaking Division\n2\n\n<<<PAGE 3>>>\n\nNickels\n173.125\nP.O.Box 7\nCool, CA 95614\n28 July 2013\nU.S. Dept. of Transportation\nPHMSA East Bldg, 2nd Floor\n1200 New Jersey Ave. SE\nWashington, DC 20590\nAttn: Office of Standards\nRe: Inquiry Letter\nto whom it may concern:\nOn 23 July 2014, I spoke to Mr. Matt Nichols about this matter. On 25 July I spoke\nto Ms. Diane Lavalle about special permits. Both staff of PHMSA were\nknowledegable and helpful. Because the technical questions are so complicated, i am\nrequesting a written clarification.\nThis inquiry involves a conflict between 49CFR and the UN classification of\ndangerous goods. My client, Gesellschaft fuer Gefahrgut m.b.H., in Romanshorn,\nSwitzerland, seeks to arrange import of a pharmaceutical based on UN3088, a solid,\niron-based phosphate binder for kidney disease patients. My client's UN3088 is\nDivision 4.2, PG-I, according to the UN Manual of Tests as required in\n49CFR173.125. That's the key, both 49CFR and UN regulations specify the same lab\ntest manual.\nAppendix 6 of that same UN Manual allows an alternative method of classification\nfor Division 4.2 in that:\n\"5.2.2. The classification procedure for self-heating substances need not be\napplied if the results of a screening test can be adequately correlated with the\nclassification test and an appropriate safety margin is applied. Examples of\nscreening tests are (...Grewer Oven Test and Bulk Powder Screening Test).\"\nThat gets to my question. I do not find Appendix 6 mentioned in 49CFR. Is that\nalternative classification method available in the PHMSA view? Is a special permit\nrequired or it there a simpler way?\nThank you for your attention to this urgent matter.\nSincerely,\n...!.::\nf05**55\nDatal\nDavid Dietrich, PE\nemai(\nmodesto3@gmail.com","truncated":false,"body_characters":6848}