{"operation":"document","citation":"99-0067","title":"Arnold & Porter — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"1999-05-28","effective_on":null,"summary":"99-0067 response to Arnold & Porter concerning 171.8.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-99-0067.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-99-0067.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-99-0067","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/1999/990067.pdf","body":"<<<PAGE 1>>>\n\n•\nof Transportation\nU.S. Department\nWashington, D.C. 20590\n400 Seventh Street, S.W.\nResearch and\nSpecial Programs\nAdministration\nMAY 28\n1999\nMr. Lawrence E. Culleen\nRef. No. 99-0067\nCounsel to Cottrell, Ltd.\nArold & Porter\n555 Twelfth Street, N. W.\nWashington, DC 20004-1206\nDear Mr. Culleen:\nThis is in response to your letter dated March 9, 1999, inquiring whether your client's product,\n\"VapoCide™\", which is a Class 3, Packing Group II material, qualifies for shipment as a\nConsumer commodity, ORM-D, under the Hazardous Materials Regulation (49 CFR Parts 171-.\n180).\nYou stated that the product is composed of alcohols (92%), formaldehyde (23%), and other non-\nhazardous materials (7.7%). It is packaged in conformance with the limited quantity provision in\n§ 173.150(b)(2). The product is primarily used by medical and dental professionals to sterilize\nhealth care instruments and is not directly distributed for retail sale to personal or household\nconsumers.\nThe definition of a consumer commodity in § 171.8 includes a material that is packaged and\ndistributed in a form suitable for retail sale for consumption by individuals for purposes of\npersonal use or household use even if not specifically so intended. Wè agree that the product is\nsuitable for household or individual use and, therefore, qualifies for shipment as \"Consumer\nCommodity, ORM-D.\"\nI trust this satisfies you inquiry. Please contact us if we can be of further assistance\nSincerely,\nHothe z Michell\nHattie L. Mitchell, Chief\nRegulatory Review and Reinvention\nOffice of Hazardous Material Standards\n990067\n\n<<<PAGE 2>>>\n\nMAR-09-99\n15:01\nFrom: AdP DC 951\n2029425999\n1-395 P. 02/05\nJ0b-U44\nARNOLD & PORTER\nNEW YORK\nWASHINGTON, D.C. 20004-1206\n555 TWELFTH STREET, N.W\nDENVER\n(2021 842-5477\nLAWRENCE E. CULLEEN\nFACSIMILE: 12021042:5091\n(202) 9425000\nLOS ANGELES\nLONDON\nStevens\nMarch 9, 1999\n$1718\nYIA FACSIMILE\nEdward Mazzullo, Director\nConsumer Commodity\nOffice of Hazardous Materials Standards\n99-0067\nU.S. Department of Transportation\n400-7' Street, S. W.\nWashington, D.C. 20590\nDear Mr. Mazzullo:\nI am writing on behalf of Cottrell, Ltd. (Cottrell) to request your written\ndetermination that a certain product qualifies for the exemption from the Hazardous\nMaterials Regulations (HMR) for certain materials when they are packaged in limited\nquantities, renamed as a \"Consumer commodity\", and reclassified as Other Regulated\nMaterials (ORM-D) pursuant to 49 C.F.R. §5 173.150(b) and (c).\nCottrell is a manufacturer and distributor of an homogeneous, single-phase liquid\nproduct known as VapoCide™M which is composed of ethanol (57%), methanol (35%),\nformaldehyde (23%), and other non-hazardous materials (7.7%). VapoCide™M has a\nflashpoint of approximately 65°F when measured using test methods specified in\n§ 173.120 (ASTM D-56). This product is distributed by Conrell primarily to wholesalers\nand to a limited number of end-users. VapoCide™ is intended for use in medical and\ndental offices in conjunction with a Chemiclave® (a tabletop device used to sterilize\nhealth-care instruments).\nVapoCide™ is packaged for surface transportation in combination packaging\nincluding one liter inner packaging (plastic bottles) within a strong outer packaging (a\ncorrugated cardboard carton) weighing no more than 30 kilograms gross weight. Based\nupon its flashpoint and composition, VapoCide™M would be considered to be a Packaging\nGroup II material; and when packaged and shipped as described, it qualifies for the\nlimited quantities exemption. See §§ 173.121 and 173.150(b).\nAlthough it is not distributed by Cottrell directly for retail sale to consumers for\ntheir personal use, VapoCide™ is packaged within small individual-use bottles and with\ninstructions for its use by individuals in medical and dental offices (some of which could\nbe situated within home offices).' Further, Cottrell does not restrict its distributors or\n' To our knowledge, consumers who undergo certain home therapies or medical treatments also may own\nor lease a Chemiclaved and raquire VapoCide™M as an adjunct to is use.\n200313\n\n<<<PAGE 3>>>\n\n1...\nFrom: Adr Do wol\nARNOLD\n& PORTER\nOffice of Hazardous Materials Standards\nEdward Mazzullo, Director\nMarch 9, 1999\nPage 2\nprivate labelers from distributing VapoCide™ into wholesale or retail markets from\nwhich medical professionals and consumers might obtain it. Applying previous\ninterpretations issued by your office concerning functionally identical products, we\nconclude that VapoCide™ qualifies for reclassification as a Consumer commodity,\nORM-D. See 5$ 171.8 and 173.150(c) and Ms. Hattie L. Mitchell's April 17, 1998 letter\nto Dr. Roger L. Goodman, enclosed along with his September 19, 1997 inquiry. This\nconclusion also is consistent with advice we have received in telephone inquiries made\non February 16 and 17, 1999 to Mr. Michael Stevens of the Research and Special\nPrograms Administration (RSPA) hotline.\nCottrell intends to rely upon the advice received from the RSPA hotline staff and\nrequests that you please confirm in writing the accuracy of the interpretation that has\nbeen provided as applied to Cottrell's VapoCide™M product. If you require additional\ninformation concerning this product, please contact me at once (at 202/942-5477).\nSincerely,\nE lul\nLawrence E. Culleen\nCoansel to Cottrell, Ltd.\nEnclosures\ncc: Ed Cassinis, Cottrell, Ltd.","truncated":false,"body_characters":5371}