{"operation":"document","citation":"10-0093R","title":"Edgcomb Law Group — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2010-09-22","effective_on":null,"summary":"10-0093R response to Edgcomb Law Group concerning 171.8, 173.156.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-10-0093r.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-10-0093r.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-10-0093r","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretations/2010/100093R.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department of Transportation Pipeline and Hazardous Materials Safety Administration\nSEP 22 2010\n1200 New Jersey Ave, SE\nWashington, D.C. 20590\nMr. John Edgcomb\nEdgcomb Law Group\n115 Sansome Street, Suite 700\nSan Francisco, CA 94104\nRef. No.: 10-0093R\nDear Mr. Edgcomb:\nThis responds to your letter dated April 22, 2010 and follow-up letter on July 22, 2010 regarding the\nrequirements for shipping a \"Consumer commodity, ORM-D\" material in accordance with the\nHazardous Materials Regulations (HMR; 49 CFR Parts 171-180). This is a revision to our original\nresponse from June 14,2010.\nAccording to your letter, your client is a pharmaceutical distributor, and proposes to unitize\nproducts classified as \"Consumer commodity, ORM-D\" into securely fastened, plastic boxes\n(\"totes\") for delivery from its distribution centers to its customers in their healthcare settings,\nincluding retail pharmacies, hospitals, physician practices, extended-care facilities, home-care\nagencies and government medical facilities. The individual totes are loaded into a contract carrier's\nmotor vehicle, which is used exclusively for the delivery of the totes. Also, your client's customers\nsometimes return the totes containing similar materials using the same methods. You ask, would\nthe exception in § 173.156(b)(I) apply to these ORM-D materials and whether the ORM-D marking\nis required on the \"totes\".\nIn general, the HMR permit materials that meet the definition of a consumer commodity in\n§ 171.8 and that are packaged as provided in the appropriate limited quantity packaging section to\nbe renamed \"Consumer commodity\" and reclassed as ORM-D. An ORM-D material is excepted\nfrom labeling, placarding and specification packaging, and except for shipments by aircraft, the\nshipping paper requirements, unless the materials meet the definition of a hazardous substance,\nhazardous waste, or marine pollutant.\nConsumer commodity, ORM-D materials may be transported utilizing the exceptions in\n§ 173.156(b)(1), including the exception from the marking requirements of Subpart D of Part 172\n(I.e., \"ORM-D\" marking), provided the material is (l) unitized in cages, carts, boxes, or similar\noverpacks; (2) offered for transportation or transported by rail, private or contract motor carrier; or\ncommon carrier in a vehicle under exclusive use for such service; and (3) transported to or from a\nmanufacturer, a distribution center, a distribution center, and a retail outlet, or transported to a\ndisposal facility from one offeror. According to your incoming letter, your clients shipping\nmethods satisfy all three ofthese conditions. Thus, your client may take advantage ofthe\n\n<<<PAGE 2>>>\n\nexceptions provided in § 173 .156(b)( 1), including the exception from marking the box or tote\n\"ORM-D\".\nI hope this information is helpful. If we can be of further assistance, please contact us.\nSincerely,\nt:S~B~~\nChief, Standards Development\nOffice of Hazardous Materials Standards\n\n<<<PAGE 3>>>\n\n115 Sansome Street, Suite 700\nSan Francisco, California 94104\n415.399.1555 direct\n415.399.1885 fax\njedgcomb@edgcomb-Iaw.com\n['i ~ V1 en (lUCb\n~ 113· I~fo (Ia)\nSxeep-hons -Por OKM- D\nBY OVERNIGHT MAIL Mex1-e n'als\n10-0/5B\nJuly 22, 2010\nMr. Edward T. Mazzullo\nDirector, Office ofHazardous Materials Standards\nU.S. DOT/PHMSA (PHH-I0)\n1200 New Jersey Avenue, SE\nWashington, D.C. 20590-0001\nRe: Request for Additional Interpretation of 49 C.F.R. § 173 . 156ili\nDear Mr. Mazzullo:\nI write to request additional clarification regarding the applicability of the exception to\nthe marking requirements for ORM-D materials provided in 49 C.F.R. § 173.156(b).\nMy April 22, 2010 letter sought clarification on whether the exception in § 173 .156(b )(1 )\napplied to \"consumer commodity\" ORM-D materials distributed by my client. More\nspecifically, we asked whether the ORM-D marking was required when such materials were\nunitized in boxes/plastic totes and offered for transport by private, contract, or common carrier\ndedicated for such service and transported from the distributor directly to a retail outlet,\npharmacy, hospitals, physician offices, or other healthcare facilities (the dedicated transporters\nmay make multiple stops/deliveries to said healthcare facilities along their routes).\nThe June 14, 20lO response I received from Charles E. Betts, Chief of Standards\nDevelopment, contains what could be construed to be an interpretation of § 173 .156(b )(1) and\n(2) that is inconsistent with a prior interpretation issued by the Pipeline and Hazardous Materials\nSafety Administration (\"PHMSA\"). Specifically, the last paragraph of Mr. Betts' June 14, 20lO\nresponse restates the requirements of both § 173.156(b)(1) and (2), and thus could be construed\nto suggest that the conditions described in both (b)(1) and (2) must be met under the factual\ncircumstances we describe above and still require the package to be marked with the ORM-D\nmarking in accordance with §172.316. We do not believe this to be correct and therefore seek a\nfurther clarification.\n\n<<<PAGE 4>>>\n\nMr. Edward T. Mazzullo\nDirector, Office of Hazardous Materials Standards\nJuly 22, 2010\nThe terms of § 173.1 56(b)(2) simply provide another, separate exception to 30 kg weight\nlimitation in addition to the one provided in § 173.156(b)(1). The terms of § 173.156(b)(2) apply\nonly to the shipping of consumer commodities with inner packagings packed in a specified\nmanner (i.e.: those set forth in sub-section (b )(2)(i)-(iv)). Thus, it is our understanding that the\nrequirement of § 173.156(b)(2) to place the ORM-D mark on such packages is inapplicable to\nour factual circumstances, to which § 173 .156(b)( 1) applies, meaning that compliance with the\nORM-D marking requirements is specifically excluded.\nOur understanding in this regard is consistent with the PHMSA's prior interpretation of\nthe ORM-D marking exception provided by § 173 .156(b)( 1). In Interpretation 99-0036, issued\non May 24, 1999, the PHMSA stated that if the requirements of § 173.156(b)(1) [alone] are met,\nthen the ORM-D marking requirements in § 172.316 need not be met. See also Interpretation\n10-0030, issued on March 10,2010.\nThus, we write to seek further clarification that a shipper whose shipment meets the\nrequirements of § 173.156(b)(1) qualifies for the exception from the ORM-D marking\nrequirements of § 172.316, without any regard to the terms of § 173.l56(b)(2) whatsoever.\nThank you for your attention to this request. I look forward to your response.\n{OOO11659,DOC-l}\n2","truncated":false,"body_characters":6510}