{"operation":"document","citation":"98-0563","title":"STC Technologies, Inc. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"1998-05-15","effective_on":null,"summary":"98-0563 response to STC Technologies, Inc. concerning 173.306.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-98-0563.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-98-0563.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-98-0563","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/1998/980563.pdf","body":"<<<PAGE 1>>>\n\n1\nU.S. Department\nof Transportation\n:\nSpecial Programs\nResearch and\nAdministration\nMAY | 5 1998\nR. Sam Niedbala, Ph.D., BCFE\nExecutive Vice President\nSTC Technologies, Inc.\n1745 Eaton Avenue\n• Bethlehem, Pennsylvania 18018\nDear Dr. Niedbala:\nThis responds to your letter of April 27, 1998, addressed to\nMI. Edward Mazzul10, Director, Office of Hazardous Materials\nStandards, concerning limited quantity shipments of compressed\ngases.. Specifically, you' request confirmation that your\nHistofreezer® device qualifies to be shipped as a limited\nquantity under § 173.306 of the Hazardous Materials Regulations\n(HMR; 49 CFR Parts 171-180).\nIn your letter, you describe the Histofreezer® device as a metal\ncanister containing 90 milliliters (3.16 oz.) of liquefied gas.\nThe liquefied gas is a mixture consisting of 75 percent dimethyl\nYour understanding is correct. The Histofreezer® device,\nconsisting of a mixture of liquefied compressed gases in\ncontainer of not more than four fluid ounces capacity, meets the\na\nHMR and is therefore exempt from specification packaging\ndefinition for a limited quantity under $ 173.306 (a) (1) of the\nrequirements and from labeling requirements, except when offered\nfor transportation by air.\nYou may also wish to take advantage of certain exceptions to the\nregulations available for shipments of consumer commodities:\nconsumer commodity, defined in § 171.8 of the HMR, is a material\nA\nthat is packaged\nand distributed in\na form intended or suitable\nfor sale through retail sales agencies or instrumentalities for\nconsumption by individuals for purposes of personal care or\nhousehold use. This definition includes drugs and medicines.\nProducts that meet the definition of consumer commodity in\n$ 171.8 and that conform to the packaging requirements of\nORM-D material.\n$ 173.306 may be renamed \"consumer commodity\" and reclassed as\nPackages of ORM-D material must be marked\n\"Consumer Commodity, ORM-D\" in accordance with $ 172.316.\n\n<<<PAGE 2>>>\n\n•\n2\nShipments of ORM-D materials are not subject to the shipping\npaper requirements of Subpart C of Part 172 of the HMR unless the\nmaterial meets the definition of a hazardous substance or\nhazardous waste or unless offered for transportation by air.\nI hope this satisfies your request.\nSincerely,\nThoma t. All\nlen\nThomas G. Allan\nSenior Transportation Regulations Specialist\nOffice of Hazardous Materials Standards\n\n<<<PAGE 3>>>\n\n655.3/66\nSIC Technologies, Inc.\ndetection technologies for the next millennium\nApril 27, 1998\nMr. Edward T. Mazzullo\nDirector, Office of Hazardous Materials\nU.S. Department of Transportation\nResearch and Special Programs Administration\n400 Seventh Street, S.W.\nWashington, D.C. 20590\nRe:\nHistofreezer® Device\nRequest for Exception from Hazardous Materials Shipping and Labeling Requirements for\nDear Mr. Mazzullo:\nIn accordance with 49 CFR §173.306(a)(1) and for the reason stated herein, STC Technologies,\nInc. requests an exception from the Hazardous Materials shipping and labeling requirements for\nHistofreezer® device, a product used for the removal of warts and benign skin lesions.\nThe Histofreezer® device is manufactured by Koninklijke Utermöhlen N.V., located in the\nNetherlands and is distributed in the U.S. solely by STC Technologies. The Histofreezer® device is\ncomposed of a metal canister containing 90 milliliters (3.16 oz.) of liquefied gas (75 percent\ndimethyl ether and 25 percent propane) and disposable 2 millimeter or 5 millimeter plastic foam\ntips that must be attached to the canister during usage. The device operates by saturating the tip of\nthe applicator with the liquefied gas. As the liquefied gas evaporates from the bud, the applicator\nreaches a very low effective temperature thereby allowing the removal of warts or other lesions.\nAs noted above, the chemical composition of the Histofreezer® device includes a mixture of\ndimethyl ether and propane. As stated in 49 CFR §172.101, both substances are subject to\npackaging and labeling exceptions outlined in 49 CFR §173.306 for limited quantities of\ncompressed gases. A limited quantity of compressed gas is defined by 49 CFR $173.306(a)(1), in\nwhich the compressed gas is packaged in \"containers of not more than 4 fluid ounces capacity\n(7.22 cubic inches or less)...\" Based on this definition, the Histofreezer® device as described above\nmeets the requirements for limited quantities of compressed gases and should therefore be excepted\nfrom the Hazardous Materials packaging and labeling requirements specified in the regulations.\nYour rapid review and response to this request is greatly appreciated. Please do not hesitate to\ncontact me at (610)882-1820 if you have any questions or need additional information.\nSincerely,\nRSan\nR. Sam Niedbala, Ph.D., BCFE\nExecutive Vice President\n1745 Eaton Avenue • Bethlehem, Pennsylvania 18018-1799\n(610) 882-1820 • (610) 882-1830 FAX","truncated":false,"body_characters":4883}