{"operation":"document","citation":"99-0108","title":"PATTON BOGGS LLP — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"1999-05-11","effective_on":null,"summary":"99-0108 response to PATTON BOGGS LLP concerning 171.1.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-99-0108.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-99-0108.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-99-0108","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/1999/990108.pdf","body":"<<<PAGE 1>>>\n\nof Transportation\nUS. Department\nWashington, D.C.\n400 Seventh Street, S.W.\n20590\nResearch and\nAdministration\nSpecial Programs\nMAY 1 | 1999\nMs. Carolina L. Mederos and\nRef No. 99-0108\nMr. Duane A. Siler\nPATTON BOGGS LLP\nAttorneys at Law\n2550 M Street, NW\nWashington, DC 20037-1350\nDear Ms. Mederos and Mr. Siler:\nThis is in response to your letter of April 26 1999, requesting confirmation of your understanding\nof the definition for \"consumer commodity\" under the Hazardous Materials Regulations (HMR;\n49 CFR Parts 171-180) as it applies to your client's product \"Vapo-Steril.\"\nYou describe \"Vapo-Steril\" as an alcohol-based sterilant, consisting of 72,36% ethanol and\n0.23% formaldehyde, with the balance being inert ingredients. It is classified ås a Class 3\n(flammable liquid) in Packing Group I and is used in a vaporizing sterilizer to sterilize\ninstruments and other apparatus, mainly for dental and medical purposes. Vapo-Steril is\npackaged in one liter containers by the manufacturer. Four such four-packs, a total of 16 one\nliter containers, are placed in an outer packaging or box. The total weight of the entire package\nis approximately 35 pounds. You indicate it is similar to household sterilizing solutions whose\nactive ingredient is alcohol and which are sold to consumers at retail\nAs you are aware, the definition of a consumer commodity in § 171.8 includes a material that is\npackaged and distributed in a form suitable for retail sale for consumption by individuals for\npurposes of personal use or household use even if not specifically so intended. We agree that the\nproduct Vapo-Steril, in the described formulation and quantity limits, is suitable for household use\nand therefore qualifies for shipment as a \"Consumer commodity, ORM-D.\"\nI hope this information is helpful. If we can be of further assistance, please contact us.\nSincerely,\nPlant. Mazal\nEdward T.\nDirector, Office of Hazardous Materials\nStandards\n990108\n\n<<<PAGE 2>>>\n\n',\nPATTON BOGGS LIP\nWashington, DC 20037-1350\n- 2550 M Street, NW\nATTORNEYS AT LAW\n202-457-6000\nFacsimile 202-457-6315\nApril 26, 1999\n202-457-5615\nDuane A. Siler\ndsiler@pattonboggs.com\n202-457-5653\nCarolina L. Mederos\ncmederos@pattonboggs.com\nVIA US MAIL AND FACSIMILE\nMr. Edward Mazzullo - DHM-10\nDirector, Office of Hazardous Materials Standards\nResearch and Special Programs Administration\nU.S. Department of Transportation\n400 7* Street, S.W.\nRoom 8102\nWashington, DC 20590\nRe:\nStatus of Alcohol-Based Vaporizer Sterilant Product Under Federal HazMat\nRegulations\nDear Mr. Mazzullo:\nWe are writing to memorialize our conversation on Thursday, April 23, 1999 and\nto request written confirmation that a product known as Vapo-Steril is a consumer\ncommodity within the meaning of 49 C.F.R. 171.8\nAs we explained, Vapo-Steril is an alcohol-based sterilant. The product contains\n72.36% ethanol and 0.23% formaldehyde, with the balance being inert ingredients.\nThe material is manufactured and marketed by Barnstead/Thermolyne, a subsidiary of\nour client, Sybron International Corporation of Milwaukee. Vapo-Steril is designed for\nuse in a specific type of vaporizing sterilizer, the Chemiclave EC Series Sterilizer, which\nis used to sterilize instruments and other apparatus, mainly in dental and medical\noffices. The current MSDS for Vapo-Steril is attached\nThe product is packaged in one-liter containers at the point of manufacture.\nThese containers are packaged in four-packs, which are shipped to customers in outer\nANCHORAGE • DALLAS • DENVER GREENSBORO\nSEATTLE\nWASHINGTON, DC\n\n<<<PAGE 3>>>\n\nPATTON BOGGS LLP\nATTORNEYS AT LAN\nMr. Edward Mazzullo\nApril 27, 1999\nPage 2\nboxes containing four such four-packs, or a total of 16 one-liter containers in each box.\nThe total weight of the entire package is approximately 35 pounds.\nWe understand that, because it contains 72:36% ethanol, Vapo-Steril is a\n\"hazardous material\" under the Hazardous Materials Table, 49 C.F.R. 172.10, and\nwould be classified as \"alcohol n.o.s.\" with UN 1987. We further understand that, due\nto its indicated flash point of 71-75 degrees F, Vapo-Steril would be considered a\nflammable liquid (Class III) and is in Packaging Group II under 49 C.F.R. 173.121.\nAs we discussed, based on the form in which Vapo-Steril solution is shipped, i.e.,\nin a strong outer box containing 16 one-liter bottles, with a gross weight of less than 66\npounds, these shipments are \"limited quantities\" within the meaning of 49 C.F.R.\n173.150(b)(2).\nYou indicated that, because it resembles many alcohol-based consumer products,\nVapo-Steril probably can be cõnsidered a \"consumer commodity\" under 49 C.F.R.\n171.8. As such, if shipped in \"limited quantities,\" as at present, Vapo-Steril can\nlawfully be labeled \"ORM-D\" and shipped as \"consumer commodities\" under 49 C.F.R.\n173.150(c) without the necessity for hazardous material shipping papers (unless\ntransported by air).\nThe term \"consumer commodity\" is defined under Department of Transportation\n(DOT) regulations as \"a material that is packaged and distributed in a form intended or\nsuitable for sale through retail sales agencies or instrumentalities for consumption by\nindividuals for purposes of personal care or household use. 49 C.F.R. 171.8. You\nadvised that this definition can include a product like Vapo-Steril that is shipped for sale\nto professional end-users for more specialized applications, provided the product is\nsubstantially similar to some household product. In terms of its composition, Vapo-Steril\nsolution is very similar to rubbing alcohol or other alcohol-based household sterilants.\nWe therefore conclude that this product can properly be considered a \"consumer\ncommodity.\"\nWe note that your advice is consistent with that previously provided by the\nOffice of Hazardous Materials Standards (OHMS). For example, in a letter dated May\n23, 1997, and posted on DOT's website, OHMS advised the manufacturer of an aerosol\nproduct used solely for industrial applications that limited quantities of the product\ncould be shipped as ORM-D. See letter from Delmer F. Billings, Chief, Regulations\n\n<<<PAGE 4>>>\n\n:\nPATION BOGGS LLP\nATTORNEYS AL LAN\nMr. Edward Mazzullo\nApril 27, 1999\nPage 3\nDevelopment, to Ms. Karen E. Liedigk (May 23, 1997) (copy attached). As OHMS\nexplained: \"this definition [of consumer commodity] includes materials that are suitable\nfor retail sale even if not specifically so intended and which may, in fact, be used in\nsome other fashion.\" (emphasis added) The letter went on to note that the shipper's\nproduct, a type of marking fluid, \"is for industrial use only and not suitable for\nhousehold use.\" Nevertheless, because of the product's similarities to spray paint, some\nof which may have household applications, OHMS concluded it met the definition of a\nconsumer commodity.\nLike the industrial marking fluid at issue in the foregoing interpretation, Vapo-\nSteril is not generally suitable or cost-effective for household use, primarily because it is\ndesigned for use in a vapor sterilizer devise by health care professionals. However, the\nproduct contains predominantly ethanol and therefore is substantially similar to\nhousehold sterilizing solutions whose active ingredient is alcohol and which are sold to\nconsumers at retail. In addition, Vapor-Sterilant would present no greater risks when\ntransported in limited quantities than would alcohol-based househöld products.\nThe status of Vapo-Sterilant under the HazMat regulations has very significant\nand time-sensitive commercial implications for its manufacturer. For this reason, we\nrespectfully ask that OHMS confirm as soon as possible in writing that, based on the\nfacts presented, Vapo-Steril would qualify as a consumer commodity under section\n171.8. We also ask that you advise us at once if you believe the foregoing analysis of\nthe regulations, or the conclusion we reach, is incorrect in any material, way.\nSincerely,\nCarolina L. Mederos\nDunne Sitteen\nDuane A. Siler\nAttachments","truncated":false,"body_characters":7963}