{"operation":"document","citation":"02-0309","title":"RCS, Inc. - Ohio — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2003-01-02","effective_on":null,"summary":"02-0309 response to RCS, Inc. - Ohio concerning 171.8.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-02-0309.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-02-0309.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-02-0309","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2002/020309.pdf","body":"<<<PAGE 1>>>\n\nus anorion\nJAN M2 2003\n400 Seventh St., S.W.\nResearch and\nWashington, D.C. 20590\nSpecial Programs\nAdministration\nMr. Jeff Henderson\nRCS, Inc. - Ohio\nReference No.: 02-0309\n950 Taylor Station Road\nGahanna, OH 43230\nDear Mr. Henderson:\nThis is in response to your letter concerning the exceptions for Consumer commodities, ORM-D,\nunder the Hazardous Materials Regulations (HMR; 49 FR Parts 171-180). Specifically, you\nask if your products, Intravenous starting kits and Dressing change kits, that contain an alcohol\nthat the swabs contain 2 to 10 mL of alcohol or alcohol and iodine solution and are packaged in a\npad and/or an iodine/alcohol swab may be shipped as Consumer commodity, ORM-D. You state\nhermetically sealed pouch. The pouch contains free liquid when manufactured. These products\nare shipped to hospitals and health care facilities.\nIn general terms, a consumer commodity, as defined in 49 CFR 171.8, is a material that is\npackaged and distributed in a form intended or suitable for sale through retail sales agencies or\ninstrumentalities for consumption by individuals for purposes of personal care or household use.\nThe definition includes materials that are suitable for retail sale even if not specifically so\nintended and which may, in fact, be used in some other fashion. It is the opinion of this office\n\"Consumer commodity, ORM-D.\"\nthat the Intravenous starting kits and Dressing change kits would qualify for shipment as\nI hope this satisfies your request.\nSincerely,\nHollez. mitkell\nHattie L. Mitchell\nChief, Regulatory Review and Reinvention\nOffice of Hazardous Materiais Standards\n020309\n171.8\n\n<<<PAGE 2>>>\n\nCorbin\nRCS\n$171.8c)\nConsummer Commodite\nNovember 26, 2002\n02 - 0309\nResearch and Special Programs Administration\n400 7* Street SW\nDHM-10.\nWashington D.C. 20590-0001\nAttn: Edward Mazzullo-Director of the Office of Hazardous Materials Standards..\nRe: Letter of Interpretation under the Consumer Commodity Definition\nDear Mr. Mazzullo,\nThe following, requests a letter of interpretation regarding the applicability of the\ndefirition of a Consumer Commodity as stated in 49 CFR 171.8. RCS, Inc's\nproducts, requesting interpretation, are Intravenous (IV) Starting Kits and\nclient, Becton Dickinson, manufactures and ships medical products.\nDressing Change Kits, which contain an Alcohol pad and/or an lodine/Alcohol\nSwab.:\nThese. products are shipped to hospitals and health care facilities for\npatient care purposes\nAlcohol. and lodine Swabs consist of 2 ml to 10ml of alcohol or alcohol and\niodine solution.\nThe swabs are packaged in a hermetically sealed pouch and\ncontain free liquid when manufactured. These products are regarded by the FDA\n*as being Generally Regarded as Safe an Effective (GRASE) under the Tentative\"\nFinal Monograph for Health-care Antiseptic Drug Products.\nspecialized use in changing patient dressing or starting an IV.\nDressing Change Kits and IV Starting Kits are prepackaged products for\nWithin the\nprepackaged kits are Alcohol or Alcohol and lodine Swabs identical to those\nwith a Tyvek lid to maintain sterility and prevent breakage during transport or\noutlined above. IV Start Kits are packaged in a thick plastic pouch and sealed\nhandling. Dress Change Kits are packaged in rigid plastic trays and sealed with\n•a plastic pouch to prevent breakage during transportation and handling.\nA letter of interpretation is requested to allow for shipment of the above products\nas Consumer Commodity, ORM-D materials. While the above products are\nmanufactured and intended for clinical use, the type of packaging utilized for the\n• products can be suitable in household use or personal care.\n\"Under the current definition, a Consumer Commodity means a material that is\npackaged and distributed in a form intended or suitable for sale through retail\n\n<<<PAGE 3>>>\n\nsales agencies or instrumentalities for consumption by individuals for purposes of\npersonal care or household use. This term also includes drugs and medicines\nIt is the opinion. of Becton Dickinson and RCS, Inc. that the above mentioned\nproducts can\n• classified as Consumer Commodity, ORM-D materials.\nTherefore, it is requested that a letter of interpretation be formed to acknowledge\nIf the above products may be shipped as a Consumer Commodity, ORM-D\nmaterials.\nAdditional information regarding the above products can be obtained from the\nfollowing sources:\nBecton Dickinson\nRand Pugmire\nJeff. Henderson\nRCS, Inc.\n9450 South State St.\n950 Taylor Station Rd, St M\nPhone: 801-565-2550\nSandy, UT 84070\nPhone: 614-552-8530 x 31\nGahanna, OH 43230\nFax: 801-565-2749\nFax: 61.4-552-8541\nsend a hard copy to the above fax numbers and addresses. Your cooperation\nUpon determination and completion of a letter of interpretation, please fax and:\nand timeliness is greaty appreciated.:\nSincerely\nJeff Henderson\nTechnical Consultant\nRCS, Inc.","truncated":false,"body_characters":4862}