{"operation":"document","citation":"15-0142","title":"Covington & Burling LLP. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2016-05-17","effective_on":null,"summary":"15-0142 response to Covington & Burling LLP. concerning 173.150, 173.22.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-15-0142.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-15-0142.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-15-0142","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2016/150142.pdf","body":"<<<PAGE 1>>>\n\nof Transportation\nU.S. Department\n1200 New Jersey Avenue, SE\nWashington, D.C. 20590\nMaterials Safety\nPipeline and Hazardous\nAdministration\nMAY 1 7 2016\nMr. Thomas Brugato\nCovington & Burling LLP\nOne CityCenter\n850 Tenth Street NW\nWashington, DC 20001-495\nRef. No. 15-0142\nDear Mr. Brugato:\nThis letter is in response to your July 7, 2015 e-mail requesting clarification of the Hazardous\nMaterials Regulations (HMR; 49 CFR Parts 171-180) applicable to medicines containing\nlimited quantities of ethyl alcohol or ethanol. You ask whether Federal Drug Administration\n(EDA) regulated drugs which are transported for clinical trials or which must be dispensed to\npatients directly by doctors or similar healthcare profesionals are considered \"medicines\" for\nthe purposes of the exception provided in § 173.150(g). You also ask whether \"medicines\"\nmust be \"sold as retail products\" to be transported under the exception provided in\n§ 173.150(g).\nAs you are aware, final rule HM-233C, published March 18, 2014 [79 FR 15033] adopted\nDOT Special Permit 9275 (DOT-SP 9275) with modifications into the HMR in § 173.150(g).\nThe intent of the rule was to limit the exception to consumer products containing ethyl\nalcohol. As adopted, the exception in § 173.150(g) applies to the following specific consumer\nproducts containing ethyl alcohol, \"beverages, food, cosmetics, and medicines, medical\nscreening solutions.\" The final rule also provides an exception for ethyl alcohol contained in\n\"concentrates sold as retail products.\" The HMR does not define the terms beverages, food,\ncosmetics, or medicines. The word \"medicine\" is defined by the Merriam Webster's\ndictionary as a \"substance that is used in treating disease or relieving pain.\" In accordance\nwith § 173.22, it is the shipper's responsibility to properly classify a hazardous material. This\nOffice does not generally perform that function.\n\n<<<PAGE 2>>>\n\nHowever, it is the opinion of this Office that any medicines containing ethyl alcohol,\nincluding those intended for use in a clinical trial or administered to patients by healthcare\nprofessionals are eligible for the exception in § 173.150(g), provided all other requirements\nare met.\nI trust this information is helpful. If you have further questions, please do not hesitate to\ncontact this office.\nSincerely,\nPoste\nT. Glenn Foster\nChief, Regulatory Review and Reinvention Branch\nStandards and Rulemaking Division\n\n<<<PAGE 3>>>\n\nSuchak\n113.150(9)\nGoodall, Shante CTR (PHMSA)\nacception for class 3\nFrom:\n-0142\nSent:\nGeller, Shelby CTR (PHMSA)\nTo:\nWednesday, July 08, 2015 12:47 PM\nSubject:\nHazmat Interps\nAttachments:\nFW: Scope of 49 C.F.R. § 173.150(g)\n2015-07-07 Letter.pdf\nDear Shante and Alice,\nAttached is a request for a formal letter of interpretation.\nThanks,\nShelby\nFrom: Brugato, Thomas [mailto:tbrugato@cov.com]\nTo: PHMSA HM InfoCenter\nSent: Tuesday, July 07, 2015 5:48 PM\nSubject: Scope of 49 C.F.R. § 173.150(g)\nGood afternoon,\nPlease see the attached letter, which requests information regarding the interpretation of 49 C.F.R. §\n173.150(g).\nBest,\nThomas R. Brugato\nCOVINGTON & BURLING LLP\nOne CityCenter\n850 Tenth Street, NW\nWashington, DC 20001-495\ntel: 202.662.5515\ntbrugato@cov.com\nThis message is from a law firm and may contain information that is confidential or legally privileged. If you are not the intended recipient, please\nimmediately advise the sender by reply e-mail that this message has been inadvertently transmitted to you and delete this e-mail from your system. Thank\n\n<<<PAGE 4>>>\n\nCOVINGTON\nThomas R. Brugato\nBEIJING BRUSSELS LONDON LOS ANGELES\nSHANGHAI\nNEW YORK SAN FRANCISCO SEOUL\nCovington & Burling LLP\nSILICON VALLEY\nWASHINGTON\nOne CityCenter\nWashington, DC 20001-4956\n850 Tenth Street, NW\ntbrugato@cov.com\nT +1 202 662 5515\nBY ELECTRONIC MAIL\nJuly 7, 2015\nU.S. DOT\nAttn: PHH-10\nPHMSA Office of Hazardous Materials Standards\nEast Building\nWashington, DC 20590-0001\n1200 New Jersey Avenue, SE.\nphmsa.hm-infocenter@dot.gov\nRe: Scope of 49 C.F.R. § 173.150(g)\nDear Sir or Madam:\n§ 173.150(g) for certain products containing ethyl alcohol The question I have is whether an\nPHMSA recently released a final rule which codified an exception at 49 C.F.R\nInvestigational New Drug (regulated by the FDA) being shipped to clinical trial sites qualifies for\nthe exception as a medicine.\nsend to clinical trial sites for use in clinical trials. The drug is contained in 100 mL bottles and\nBy way of background, our client produces an investigational new drug, which it plans to\ncontains ethanol.\nof the term \"medicine,\" as a \"substance or preparation used in treating disease.\" Webster's\nThe investigational drug at issue would seem to clearly fall within the common meaning\nThird International Dictionary. However, the term \"medicine\" in the regulation is not defined,\nand so it would be useful to clarify for the regulated community that \"medicine\" is not limited to\nFDA-approved drugs, but also extends to Investigational New Drugs.\nThere is a second question of whether the exception might not apply because the\ninvestigational new drug is shipped to clinical trial sites for administration by doctors in clinical\nbut it is not clear whether that phrase applies only to concentrates or instead to all of the listed\ntrals, as opposed to retail sale. The regulation does contain the phrase \"sold as retail products,\"\nproducts. Notably, DOT-SP 9275, which the regulation codified, did not contain any \"retail\nmedical screening solutions, and concentrates used therein containing ethyl alcohol classed as a\nproduct\" limitation, but rather simply applied to \"[b]verages, foods, cosmetics and medicines,\nflammable liquid or as solids containing a flammable liquid.\" Nothing in the NPRM or final rule\ncodifying DOT-SP 9275 evinces an intent to narrow the scope of the exception. See 77 Fed. Reg.\n64,450 (Oct. 22, 2012); 79 Fed. Reg. 15,033 (Mar. 18, 2014).\n\n<<<PAGE 5>>>\n\nCOVINGTON\nJuly 7, 2015\nPage 2\n\"material [including medicines] that is packaged and distributed in a form intended or suitable\nMoreover, other exceptions use the phrase \"consumer commodity,\" which is limited to\nfor sale through retail sales agencies or instrumentalities for consumption by individuals for\npurposes of personal care or household use.\" 49 C.F.R. § 171.8. Presumably PHMSA would\nsimply have used the defined term \"consumer commodity\" had it intended 49 C.F.R.\nindividuals, but instead it chose not to do so and drafted a more expansive exception.\n§ 173.150(g) to be limited to medicines packaged and distributed for end-use consumption by\nThe vast majority of FDA-approved drugs are dispensed by pharmacists pursuant to a\nand we therefore it should follow that these drugs are \"retail products\" that fall within the scope\nprescription from a physician. Such pharmacies are generally considered \"retail pharmacies\"\nof the exception. Could you confirm this assessment is correct? However, some FDA-approved\ndrugs are only administered to patients by doctors or other healthcare providers. It seems\nunlikely that PHMSA intended to exclude such FDA-approved drugs from the scope of this\nexception, simply because the drugs are administered to patients by doctors. Could you confirm\nthat these FDA-approved drugs are also \"retail products\" within the scope of 49 C.F.R.\n§ 173.150(g)?\nFor the foregoing reasons, in our view the exception should apply to medicines that meet\n\"retail products\" should be viewed as a broad enough term to encompass the type of clinical trial\nall requirements of the regulation, even if they are not \"retail products.\" In the alternative,\nuse and administration by doctors at issue here. Please advise whether PHMSA agrees with this\nunderstanding of the regulation.\nThank you for your assistance in this matter.\nRegards,\nThomas Brugato","truncated":false,"body_characters":7787}