{"operation":"document","citation":"04-0253","title":"LSL Industries, Inc. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2004-11-17","effective_on":null,"summary":"04-0253 response to LSL Industries, Inc. concerning 172.101.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-04-0253.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-04-0253.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-04-0253","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2004/040253.pdf","body":"<<<PAGE 1>>>\n\nJ.S. Department\nof Transportatior\n400 Seventh St., S.W.\nWashington, D.C. 20590\nSpecial Programs\nResearch and\nAdministration\nNOV 17 2004\nMr. Hussein\nDirector QA/Operations\nRef. No. 04-0253\nLS Industries, Inc.\n5535 N. Wolcott Avenue\nChicago, IL 60640\nDear Mr. Hussain:\nThis is in response to your letter dated October 26, 2004, and subsequent conversation with a\nmember of rny staff, regarding the small quantity exception in the Hazardous Materials\nRegulations (HMR; 49 CFR Parts 171-180). Specifically you ask if \"Disposable Kits\" for\nhospitals qualify for the small quantity exception in § 173.4.\nYou describe two \"Disposable Kits\" in your letter:\n(1) The first (IV Start kit #1) contains several non-hazardous materials, and 0.67 ml of\nChlorhexidine Gluconate 2% in 70% Isopropyl Alcohol, which you have classified as\n\"Isopropyl alcohol solution, 3, UN1219, PG II.\"\n(2)\ncontains 1.5 ml of the isopropyl alcohol solution.\nThe second kit (IV Start kit #2) has the same configuration as the first; however, it\nreceptacle for Class 3 (Flammable) liquids. Assuming they meet the additional requirements\nBoth of these kits meet the quantity limitation in § 173.4(a)(1)(1) of 30 ml per inner\nof § 173.4, and the outside of each package is marked with the statement, \"This package\nconforms to 49 CFR 173.4,\" the \"Disposable Kits\" you described are excepted from any\nother requirements of the HMR.\nI hope this information is helpful. Please contact us if you require additional assistance.\nOffice of Hazardous Materials Standards\n/72.101\n040253\n173.4\n\n<<<PAGE 2>>>\n\nEichenlaub\n$172.101\n5113.4.\nLabeling\nLSL Industries, Inc.\nManufacturers of Quality Medical Devices & Disposable i\n04-0253\nOctober 26, 2004\nOffice of Hazardous Material\nStandard Research Special\n400 Seventh Street\nU.S Department of Transportation\nSouth West Washington. D.C 20590-0001\nAttn: DHM-10\nRe: Verification of Shipping Classification\nDear Sir/Madam,\nI am writing to you to seek your help in properly deciding any labeling requirements of\nRecently one of our customers enquired about labeling of a product IV Start Kits under\nur shipping package. We are a small Manufacturer of Disposable Kits for the Hospitals\nDOT Regulation. For example the configuration of the IV Start kit # 1 is as follows:\n1. IV Dressing (thin film to cover IV site)\n2.\nGauze (Cotton)\n3. Chlorhexidine Gluconate 2% in 70% Isopropyl Alcohol (Antiseptic ampule 0.67\nml)\n4. Tourniquet\n5. Tape\n6. Label\nIV Start kit # 2 has the same configuration except it contains 1.5 ml Chlorhexidine\nGluconate 2% in 70% Isopropyl Alcohol. These components are packed together in a\nsmall Tyvek and moisture proof plastic pouch. 100 of these individually packaged kits\nare then urther packed in a small carton weighing about 6 pounds. Considering the above\nconfiguration with only 0.67 ml and 1.5 ml of antiseptic in each individual kit, we are\ninterested in knowing the DOT labeling requirements applicable, if any, for shipping our\nproduct. Our interpretation of CFR 49& REF: 173.4 are that this product may be\nexempted for ORM-D labeling requirements under the small quantity clause.\n\n<<<PAGE 3>>>\n\nPage 2\nDOT\nWe respectfully request you to kindly verify our interpretation. If there is any regulation\nquestions as you review this request, please feel free to call me at 773-878-1100. Thank\napplicable for labeling we will be glad to implement immediately. If you have an\nyou very much for your kind consideration and favorable action.\nSincerely,\nV. Hussain\nDirector QA/Operations","truncated":false,"body_characters":3517}