{"operation":"document","citation":"00-0229","title":"Artegraft, Inc. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2000-10-03","effective_on":null,"summary":"00-0229 response to Artegraft, Inc. concerning 171.8.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-00-0229.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-00-0229.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-00-0229","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2000/000229.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\n400 Seventh St., S.W.\nof Transportation\nWashington, D.C. 20590\nResearch and\nSpecial Programs\nAdministration\nOCT\n3 2000\nMs. Cathy VanDerVeer\nRef. No. 00-0229\nArtegraft, Inc.\nP.O. Box 7305\nNorth Brunswick, NJ 08902\nDear Ms. VanDerVeer:\nI am responding to your August 11, 2000 letter regarding the definition of a consumer commodity\nunder the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) as it applies to Artegraft's\nalcohol based \"Sterilizing Solution.\"\nYou stated that your company's sterilizing solution is an alcohol based sterilant utilized in the\nmanufacturing process of an Artegraft. An Artegraft is an all collagen vascular access graft used by\nphysicians. The sterilizing solution is 50% ethyl alcohol with the remaining balance being water. The\nproduct is a Class 3 (flammable liquid) in Packing Group III, in accordance with §§ 173.120 and\n173.121, and described as \"Ethyl alcohol solutions.\"\nThe product is packaged in 500-milliliter inner containers, placed in a Styrofoam box, and then\npackaged in an outer fiberboard box. The boxes are overpacked in a fiberboard box with a higher\nburst/edge crush strength. The outer packaging contains from 1 to 10 units depending upon the\nquantities ordered. The total weight of the packages range from 4 pounds to 34 pounds. Specifically,\nbecause the components of Artegraft's sterilant are similar to many alcohol based household sterilants,\nyou believe that the alcohol based sterilizing solution meets the definition of \"Consumer commodity,\nORM-D.\"\nThe definition of a consumer commodity in § 171.8 includes a material that is packaged and distributed\nin a form suitable for retail sale for consumption by individuals for purposes of personal use or\nhousehold use even if not specifically so intended. We agree that the Artegraft alcohol based sterilizing\nsolution described in your letter is suitable for household use and qualifies to be described and classed\nas a \"Consumer commodity, ORM-D.\"\nI hope this satisfies your inquiry. If we can be of further assistance, please contact us.\nSincerely,\nmy Hasells\nDelmer F. Billings\nChief, Regulations Development\nOffice of Hazardous Materials Standards\n000229\n\n<<<PAGE 2>>>\n\nArtegraft\nEngrum\n5/71.8\nAugust 11, 2000\nConsummer\nCommodity\nVIA US MAIL AND FACSIMILE\nMr. Edward Mazzullo, Director\nOffice of Hazardous Materials Standards\nU.S. Department of Transportation\nResearch and Special Programs Administration\n400 7\"* Street, S.W.\nWashington, DC 20590\nDear Mr. Mazzullo:\nI am requesting formal written confirmation that the product known as the Artegraft Sterilizing\nSolution is a consumer commodity within the meaning of 49 C.F.R. 171.8 (pg 76 in the 10-01-99\nedition).\nprocess of an Artegraft. An Artegraft is an all coilagen vascular access graft. This graft is utilized\nThe Artegraft Sterilizing Solution is an alcohol based sterilant utilized in the manufacturing\nby physicians. The Sterilizing Solution is 50% ethyl alcohol with the remaining balance being\nwater. The MSDS for the alcohol is attached.\nbox and labeled appropriately. These packages are then packaged inside a fibreboard box.\nThe product is packaged in 500-mililiter containers. The containers are packaged in a Styrofoam\nThese boxes are then packaged inside of another fibreboard box with a higher burst/edge crush\nstrength. (Outer packaging varies from 1 to 10 units dependent upon order quantity) The total\nweight of the packages range from 4 pounds to 34 pounds.\nconsidered hazardous material under Title 49. The Artegraft is classified as \"ethyl alcohol\nI understand that because the packages contain 50% of ethyl alcohol, the Artegraft product is\nsolution and is assigned a packing group Ill. These classifications are determined under 49 CFR\n173.120 and 173.121. The flash point of the solution is 78°F (Closed Cup). (see attached)\nArtegraft can be considered a consumer commodity under 49 CFR 171.8. As such, if shipped in\nWe feel that because the steriliant solution resembles many alcohol-based consumer products.\nlimited quantities, Artegraft can lawfully be labeled \"ORM-D\" and shipped as a consumer\ncommodity under 49 CFR 173.150 (c). Shipments of ORM-D materials are not subject to the\nshipping paper requirements (unless transported by air).\nArtegraft, Inc.\nP.O. Box 7305\nNorth Brunswick, NJ 08902\n732-422-8333 Fax 732-422-8647\n800-631-5264\n\n<<<PAGE 3>>>\n\nMr. Edward Mazzullo\nPage 2\nAugust 11, 2000\ncalled Vapo-Steril that it could be shipped consumer commodity, Ref No. 99-0108. (see\nFor example, the Office of Hazardous Materials Standards issued an explanation of a sterilant\nattached).\nwell as, our distributors. I would like to request a written response, as soon as possible, as to\nYour response to the above inquiry has very significant impact on us, as the manufacturer, as\nwhether the Artegraft steriliant would qualify as a consumer commodity.\nSincerely,\nCUDI\nOffice Manager\nCathy VanDerVeer\nAttachments (3)","truncated":false,"body_characters":4947}