{"operation":"document","citation":"18-0131","title":"VA Pacific Islands Health Care System (119) — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2019-04-22","effective_on":null,"summary":"18-0131 response to VA Pacific Islands Health Care System (119) concerning 171.8, 173.150.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-18-0131.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-18-0131.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-18-0131","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/docs/standards-rulemaking/hazmat/interpretations/71196/180131.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nof Transportation\nPipeline and Hazardous\nMaterials Safety\nAdministration\n1200 New Jersey Avenue, SE\nWashington, DC 20590\nAPR 2 2 2019\nChaz Barit, Pharm.D.\nVA Pacific Islands Health Care System (119)\n459 Patterson Road\nHonolulu, HI 96819\nReference No. 18-0131\nDear Dr. Barit:\nThis letter is in response to your October 11, 2018, letter requesting clarification of the\nHazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to ground and/or air\nshipments of pharmaceuticals throughout the Hawaiian Islands. Specifically, you provided\nsafety data sheets that describe two products and ask how they should be transported. You note\nin your letter that the products described meet no other hazardous material classification (e.g. ,\nmarine pollutant). We have paraphrased and answered your questions below.\nYou describe Product 1 as a gel that contains 20% isopropanol, has a flashpoint of 18.5 °C\n(65.3 °F), and is classed as \"UN1987, Alcohols, n.o.s., Class 3 (flammable liquid), Packing\nGroup (PG) III.\" You asked the following five questions about this material.\nQI. You ask if Product 1 can be reclassified as a combustible liquid (alcohol < 24%) in\nconformance with § 173 .150( e )( 1) for transportation by aircraft.\nAl. Yes. An aqueous solution containing 24% or less alcohol by volume and no other\nhazardous materials may be reclassed as a combustible liquid regardless of the mode of\ntransport provided it complies with § 173 .150( e )(I). Additionally, combustible liquids\ntransported in \"non-bulk\" packagings-as defined in§ 171.8-are only subject to the\nHMR if they meet the definition of a hazardous substance, hazardous waste, or marine\npollutant (see § 173.150(±)(2)).\nQ2. You ask if it is necessary to consider the flashpoint (referenced in§ 173.150(±)) of\nProduct 1 if it is reclassified in conformance with the exception in § 173 .150( e )( 1 ).\nA2. No. The subparagraphs in § 173 .150( e) stand alone. Therefore, for the reasons discussed\nin Answer Al, an aqueous solution containing 24% or less alcohol by volume and no\nother hazardous material may be reclassed as a combustible liquid. If the solution\ncontains 50% or more water, it is excepted from the HMR (see§ 173.150(e)(2)).\n\n<<<PAGE 2>>>\n\nQ3. You seek confirmation of your understanding that Product 1 is excepted from the HMR\nwhen reclassified as a combustible liquid and placed in a non-bulk packaging provided\nthe product is not a hazardous substance, hazardous waste, or marine pollutant.\nA3. Your understanding is correct. See Answer Al.\nQ4. You ask if Product 1 must qualify for the exception in§ 173.150(f)(l) before it can be\nconsidered for the exception prescribed in paragraph (f)(2) of this section.\nA4. No. See Answer A2.\nQ5. You seek confirmation of your understanding that Product 1 is not subject to the HMR\nand may be transported in commerce to patients in the State of Hawaii by railcar, motor\nvehicle, or aircraft.\nAS. Your understanding is correct. See Answer Al.\nYou describe Product 2 as a gel that contains 55-70% ethanol, has a flashpoint of 21. 7 °C\n(71.06 °F), and is classed as \"UNI 170, Ethanol solution, Class 3, PG II.\" You asked the\nfollowing two questions about this material.\nQ6. You ask if Product 2 is excepted from the HMR under§ 173.150(g)(l).\nA6. Provided all the applicable requirements in § 173. l 50(g)(l) are met, the answer is yes.\nQ7. You seek confirmation of your understanding that Product 2 is not subject to the HMR\nand may be transported in commerce to patients in the State of Hawaii by railcar, motor\nvehicle, or aircraft provided the shipment complies with§§ 173. l 50(g)(l)(i)--(iii) and\n173. l 50(g)(3 )(i).\nA7. Your understanding is correct. See Answer A6.\nI hope this information is helpful. Please contact us if we can be of further assistance.\nSincerely,\n----7~~~~\nT. Glenn Foster\nChief, Regulatory Review and Reinvention Branch\nStandards and Rulemaking Division\n2\n\n<<<PAGE 3>>>\n\nI 8 -- OJ 3 i\nDr. Chaz Barit, Pharm.D.\nVA Pacific Islands Health Care System (119)\n459 Patterson Rd\nHonolulu, HI 96819\nOctober 11, 2018\nU.S. DOT\nPHMSA Office of Hazardous Materials Standards\nAttn: PHH-10\nEast Building\n1200 New Jersey Avenue, SE .\nWashington, DC 20590-0001\nDear U.S. DOT:\nVA Pacific Island's Health Care System Pharmacy provides medications through shipping in\ncommerce (non-bulk packaging), that may be considered hazardous in ground or air transport,\nthroughout the islands in the state of Hawaii. Therefore, we are requesting a clarification of the\napplicable regulations with several scenarios below, with a response in a formal letter of\ninterpretation.\nIt is understood that it is the shipper's responsibility to properly classify a hazardous material, and\nthat the PHMSA Office does not perform that function. However, we appreciate your guidance with\nthe following questions.\nProduct #1 in question: Diclofenac 1% gel\nDiclofenac 1% gel is a product that contains 20% lsopropanol (CAS# 67-63-0). The MSDS for this\nproduct states its classification as Class 3, UN 1987, Alcohols n.o.s, flash point 18.5°C, PG-Ill. There\nare no other classifications associated with this product (ie, marine pollutant, etc). In looking to\nship this product via air, we determined the applicability of 173.150(e)(l) to reclassify this product\nas a combustible liquid (alcohol <24%). Is this a correct interpretation of the CFR based on the\nproduct information provided? Do we need to consider the flash point if we have already reclassed\nthe product per 173.150(e)(l)?\nContinuing the latter, after reclassifying the Diclofenac 1% gel product as a combustible liquid we\nhave determined that 173.150(f)(2) applies in that the requirements in this subchapter do not apply\nto a material classed as a combustible liquid in a non-bulk packaging unless the combustible liquid is\na hazardous substance, a hazardous waste, or a marine pollutant. It is our understanding that the\nproduct is not applicable via 173.150(f)(l) due to it's flashpoint, but we have already determined to\n\n<<<PAGE 4>>>\n\nU.S. DOT\nOctober 11, 2018\nPage 2\nreclassify it as previous mentioned. Is this a correct interpretation and use of the CFR? Does the\nproduct need to follow 173.150(f)(l) first to be considered for 173.150(f)(2)?\nContinuing the latter, it is our interpretation that shipping this product is not subject to the\nregulations of this subch~pter, therefore we are able to ship this product in commerce to patients in\nthe state of Hawaii via ground or air without full regulation set forth by the CFR. Is that an accurate\ninterpretation?\nProduct #2 in question: Testosterone 1.62% gel\nTestosterone 1.62% gel is a product that contains 55-70% Ethanol (CAS# 64-17-5). The MSDS for\nthis product states its classification as Class 3, UN1170, Ethanol Solution, PG-Ill. There are no other\nclassifications associated with this product (ie, marine pollutant, etc). In looking into the CFR, we\nhave determined that this product is excepted from the HMR per 173.150(g)(l) as it contains no\nmore than 70% ethanol (ethyl alcohol). Is this a correct interpretation of the CFR?\nContinuing the latter, it is our interpretation that since this product is excepted from the HMR, we\nare able to ship this product in commerce to patients in the state of Hawaii via ground or air\nwithout full regulation set forth by the CFR, provided we follow the requirements of 173.150(g)(l)(i-\niii) and 173.150(g)(3)(i). Is that an accurate interpretation?\nWe appreciate the time and attention towards our request and look forward to your response. If\nyou have questions please feel free to contact me at 808-433-4979.\nSincerely,\nDr. Chaz Barit, Pharm.D.\nVA Pacific Islands Health Care System {119)","truncated":false,"body_characters":7701}