Covington & Burling LLP. — Hazardous Materials Safety Interpretation

Page 1of Transportation U.S. Department 1200 New Jersey Avenue, SE Washington, D.C. 20590 Materials Safety Pipeline and Hazardous Administration MAY 1 7 2016 Mr. Thomas Brugato Covington & Burling LLP One CityCenter 850 Tenth Street NW Washington, DC 20001-495 Ref. No. 15-0142 Dear Mr. Brugato: This letter is in response to your July 7, 2015 e-mail requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to medicines containing limited quantities of ethyl alcohol or ethanol. You ask whether Federal Drug Administration (EDA) regulated drugs which are transported for clinical trials or which must be dispensed to patients directly by doctors or similar healthcare profesionals are considered "medicines" for the purposes of the exception provided in § 173.150(g). You also ask whether "medicines" must be "sold as retail products" to be transported under the exception provided in § 173.150(g). As you are aware, final rule HM-233C, published March 18, 2014 [79 FR 15033] adopted DOT Special Permit 9275 (DOT-SP 9275) with modifications into the HMR in § 173.150(g). The intent of the rule was to limit the exception to consumer products containing ethyl alcohol. As adopted, the exception in § 173.150(g) applies to the following specific consumer products containing ethyl alcohol, "beverages, food, cosmetics, and medicines, medical screening solutions." The final rule also provides an exception for ethyl alcohol contained in "concentrates sold as retail products." The HMR does not define the terms beverages, food, cosmetics, or medicines. The word "medicine" is defined by the Merriam Webster's dictionary as a "substance that is used in treating disease or relieving pain." In accordance with § 173.22, it is the shipper's responsibility to properly classify a hazardous material. This Office does not generally perform that function.#

Page 2However, it is the opinion of this Office that any medicines containing ethyl alcohol, including those intended for use in a clinical trial or administered to patients by healthcare professionals are eligible for the exception in § 173.150(g), provided all other requirements are met. I trust this information is helpful. If you have further questions, please do not hesitate to contact this office. Sincerely, Poste T. Glenn Foster Chief, Regulatory Review and Reinvention Branch Standards and Rulemaking Division#

Page 3Suchak 113.150(9) Goodall, Shante CTR (PHMSA) acception for class 3 From: -0142 Sent: Geller, Shelby CTR (PHMSA) To: Wednesday, July 08, 2015 12:47 PM Subject: Hazmat Interps Attachments: FW: Scope of 49 C.F.R. § 173.150(g) 2015-07-07 Letter.pdf Dear Shante and Alice, Attached is a request for a formal letter of interpretation. Thanks, Shelby From: Brugato, Thomas [mailto:tbrugato@cov.com] To: PHMSA HM InfoCenter Sent: Tuesday, July 07, 2015 5:48 PM Subject: Scope of 49 C.F.R. § 173.150(g) Good afternoon, Please see the attached letter, which requests information regarding the interpretation of 49 C.F.R. § 173.150(g). Best, Thomas R. Brugato COVINGTON & BURLING LLP One CityCenter 850 Tenth Street, NW Washington, DC 20001-495 tel: 202.662.5515 tbrugato@cov.com This message is from a law firm and may contain information that is confidential or legally privileged. If you are not the intended recipient, please immediately 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#

Page 4COVINGTON Thomas R. Brugato BEIJING BRUSSELS LONDON LOS ANGELES SHANGHAI NEW YORK SAN FRANCISCO SEOUL Covington & Burling LLP SILICON VALLEY WASHINGTON One CityCenter Washington, DC 20001-4956 850 Tenth Street, NW tbrugato@cov.com T +1 202 662 5515 BY ELECTRONIC MAIL July 7, 2015 U.S. DOT Attn: PHH-10 PHMSA Office of Hazardous Materials Standards East Building Washington, DC 20590-0001 1200 New Jersey Avenue, SE. phmsa.hm-infocenter@dot.gov Re: Scope of 49 C.F.R. § 173.150(g) Dear Sir or Madam: § 173.150(g) for certain products containing ethyl alcohol The question I have is whether an PHMSA recently released a final rule which codified an exception at 49 C.F.R Investigational New Drug (regulated by the FDA) being shipped to clinical trial sites qualifies for the exception as a medicine. send to clinical trial sites for use in clinical trials. The drug is contained in 100 mL bottles and By way of background, our client produces an investigational new drug, which it plans to contains ethanol. of the term "medicine," as a "substance or preparation used in treating disease." Webster's The investigational drug at issue would seem to clearly fall within the common meaning Third International Dictionary. However, the term "medicine" in the regulation is not defined, and so it would be useful to clarify for the regulated community that "medicine" is not limited to FDA-approved drugs, but also extends to Investigational New Drugs. There is a second question of whether the exception might not apply because the investigational new drug is shipped to clinical trial sites for administration by doctors in clinical but it is not clear whether that phrase applies only to concentrates or instead to all of the listed trals, as opposed to retail sale. The regulation does contain the phrase "sold as retail products," products. Notably, DOT-SP 9275, which the regulation codified, did not contain any "retail medical screening solutions, and concentrates used therein containing ethyl alcohol classed as a product" limitation, but rather simply applied to "[b]verages, foods, cosmetics and medicines, flammable liquid or as solids containing a flammable liquid." Nothing in the NPRM or final rule codifying DOT-SP 9275 evinces an intent to narrow the scope of the exception. See 77 Fed. Reg. 64,450 (Oct. 22, 2012); 79 Fed. Reg. 15,033 (Mar. 18, 2014).#

Page 5COVINGTON July 7, 2015 Page 2 "material [including medicines] that is packaged and distributed in a form intended or suitable Moreover, other exceptions use the phrase "consumer commodity," which is limited to for sale through retail sales agencies or instrumentalities for consumption by individuals for purposes of personal care or household use." 49 C.F.R. § 171.8. Presumably PHMSA would simply have used the defined term "consumer commodity" had it intended 49 C.F.R. individuals, but instead it chose not to do so and drafted a more expansive exception. § 173.150(g) to be limited to medicines packaged and distributed for end-use consumption by The vast majority of FDA-approved drugs are dispensed by pharmacists pursuant to a and we therefore it should follow that these drugs are "retail products" that fall within the scope prescription from a physician. Such pharmacies are generally considered "retail pharmacies" of the exception. Could you confirm this assessment is correct? However, some FDA-approved drugs are only administered to patients by doctors or other healthcare providers. It seems unlikely that PHMSA intended to exclude such FDA-approved drugs from the scope of this exception, simply because the drugs are administered to patients by doctors. Could you confirm that these FDA-approved drugs are also "retail products" within the scope of 49 C.F.R. § 173.150(g)? For the foregoing reasons, in our view the exception should apply to medicines that meet "retail products" should be viewed as a broad enough term to encompass the type of clinical trial all requirements of the regulation, even if they are not "retail products." In the alternative, use and administration by doctors at issue here. Please advise whether PHMSA agrees with this understanding of the regulation. Thank you for your assistance in this matter. Regards, Thomas Brugato#