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Zipline Petition for Exemption 107.36 FINAL

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Zipline Petition for Exemption 107.36 FINAL January 14, 2021 Docket Management Facility U.S. Department of Transportation, Docket Operations 1200 New Jersey Avenue, S.E. Room W12-140, West Building Ground Floor Washington, D.C. 20590-0001 Submitted electronically through http:/www.regulations.gov Re: Zipline – Petition For Limited Exemption From 14 C.F.R. § 107.36 To Whom It May Concern: Pursuant to 14 C.F.R. Part 11, Zipline International Inc. (“Zipline,” “we,” or “us”) respectfully submits this petition requesting a limited exemption from 14 C.F.R. § 107.36 to enable it to carry hazardous materials in support of the development of a cold storage container capable of transporting the COVID-19 vaccine1 by our unmanned aircraft system (“UAS”). Specifically, we are seeking an exemption to carry (1) approximately one (1) pound of dry ice used as a refrigerant for packaging,2 and (2) lithium batteries3 contained in a data logging system to ensure the temperature remains within acceptable limits and that the vaccine is not compromised. Zipline is currently partnering with a major COVID-19 vaccine producer to develop an end-to-end cold chain solution for vaccine delivery, which would include carriage by UAS to assist with the equitable distribution of the vaccine throughout the world. While we plan to deliver the vaccine in the United States under our air carrier certificate issued under 14 C.F.R. Part 135,4 we will need to test the vaccine packaging under 14 C.F.R. Part 107 prior to distribution. Accordingly, the requested exemption is limited to these flight tests and will not be used for vaccine delivery. Carriage would be limited to test flights on two closed test ranges, each located in rural, sparsely populated areas under the control of Zipline. 1 The vaccine itself is not designated as hazardous material. 2 Dry Ice or carbon dioxide (solid) is classified as a Class 9 hazardous material (with label UN1845) under 49 C.F.R. § 172.101, and is subject to carriage limitations by 49 C.F.R. § 173.217. Pursuant to 49 C.F.R. §173.217(c)(5), dry ice in quantities not exceeding 5.5 pounds per package and used as a refrigerant for the contents of the package is excepted from all other requirements of this subchapter if packaged in accordance with §173.217(a) and marked (1) as “Dry ice” or “Carbon dioxide, solid”, (2) with the name of the contents being cooled, and (3) with either the net weight of the dry ice or an indication that the net weight is less than 5.5 pounds. 3 The lithium battery a Class 9 hazardous material under 49 C.F.R. § 172.101 (UN3481). The lithium battery contained in the equipment meets the small quantity exception in 49 C.F.R. §173.185(c). 4 Zipline is currently pursuing its Part 135 air carrier certificate and expects to obtain it early in 2021. Zipline – 14 C.F.R. § 107.36 Exemption January 14, 2021 Page 2 Granting this exemption is squarely in the public interest because it would allow testing and proof of capability to safely transport COVID-19 vaccines as cargo onboard UAS in a controlled test environment. This testing will also directly enhance the global distribution of a vaccine key to ending one of the greatest public health crises the modern world has seen. Moreover, this testing would not adversely affect aviation safety; to the contrary, it would enhance safety by ensuring that the cargo can be carried without undue hazard or compromise and contribute to the public health and welfare by demonstrating that UAS are capable of delivering COVID-19 vaccines, increasing access to the vaccine for those living in isolated and rural areas. Due to the expedited timeline required to begin testing in order to be able to assist in delivering the vaccine as early as possible in 2021, and because the public interest is served by enabling the safe delivery of vaccines by UAS to mitigate the current public health crisis, we respectfully request that this exemption request receive expedited consideration and that FAA find that the circumstances establish good cause under 14 C.F.R. § 11.87 not to publish a summary of the petition for public comment. FAA should not delay action on Zipline’s petition because our petition is non-precedential, doing so would adversely affect Zipline and the public interest by delaying validation of the delivery packaging, and because Zipline filed our request for limited exemption after discussion with FAA in which we were informed that an exemption would be required to perform the aforementioned testing activities.5 These factors weigh in favor of considering Zipline’s petition without the notice and comment period. I. BACKGROUND A. Zipline Zipline is a robotics and logistics company that designs, manufactures, and operates UAS to deliver vital medical supplies. More than two billion people across the world cannot easily access the medicine they need because of last-mile transportation challenges. We built Zipline, the world’s first and only national scale on-demand UAS delivery service, to solve that problem. At Zipline, we see every day the impact that commercial UAS operations at scale can have, including providing rural communities fast and reliable access to lifesaving medicines, eliminating unnecessary waste in scarce blood products, and improving the efficiency of the medical product supply chain. Since launching our service in Rwanda in 2016 and Ghana in 2019, Zipline has made over 90,000 UAS commercial deliveries and flown over 4.8 million miles. For the past three years, Zipline participated in the Integration Pilot Program (“IPP”) in close partnership with the North 5 See 14 C.F.R. § 11.87(a), (c), (d). Zipline – 14 C.F.R. § 107.36 Exemption January 14, 2021 Page 3 Carolina Department of Transportation (“NCDOT”) and other IPP participants. The IPP sought to accelerate the integration of small UAS operations into the national airspace system by assisting FAA and DOT in crafting rules, policies, and guidance to support more complex small UAS operations. Through its IPP participation, Zipline has worked closely with FAA to develop safe and reliable UAS operations in support of one of the NCDOT’s primary stated objectives for the IPP to “help improve healthcare access for all North Carolinians.” In May 2020, Zipline began providing UAS flight services in partnership with fellow IPP Partner Novant Health, Inc. (Novant Health) in response to the COVID-19 pandemic. As part of that partnership, Zipline has flown over 115 flights and 2,500 miles on behalf of Novant Health to distribute PPE, including N95 masks, gloves, and gowns, to frontline health staff in two Novant Health facilities in Huntersville, North Carolina. Zipline has also developed humanitarian and medical emergency response operational capabilities in partnership with the U.S. military. Since 2018, Zipline has partnered with the U.S. Department of Defense’s Defense Innovation Unit and the Naval Medical Research Center to conduct research and development and fulfill a prototype demonstration contract designed to help the U.S. Marine Corps better utilize UAS technology for operations such as disaster response and humanitarian aid missions. Zipline deployed to Australia in July 2019 to participate in a joint military exercise to demonstrate how instant UAS delivery capability could help save lives in emergency environments. With Zipline, even hard-to-reach communities can have fast and reliable access to lifesaving medical products like blood, vaccines, and essential medicines. In fact, our mission is to provide instant access to vital medical supplies for every human on Earth. Zipline now seeks to leverage its considerable experience globally and within the United States to assist in the equitable distribution of COVID-19 vaccines to help ensure rural and underserved communities have access to this life-saving medical treatment. Zipline is partnering with a major COVID-19 vaccine producer to build an end-to-end cold-chain system for drone delivery of COVID-19 vaccines. The new system will allow smaller shipments of the leading vaccine candidates—including those by Pfizer or Moderna—to be safely delivered by drone to rural and at-risk populations. The new service will also eliminate the need for health facilities to have on-site cold storage. While Zipline is developing the system for national-scale distribution across Africa, India, and other developing world countries, it could also help communities in the United States facing similar access challenges. Zipline now seeks to test this packaging inflight within the United States under an exemption from 14 C.F.R. § 107.36’s prohibition on the carriage of hazardous materials. Zipline – 14 C.F.R. § 107.36 Exemption January 14, 2021 Page 4 B. Zip UAS Zipline utilizes a thorough and holistic approach to managing risk in our operations using a combination of flight testing, ground testing, simulation, and analysis. In the course of our extensive commercial UAS operations abroad, no Zipline aircraft has experienced an uncontained flyaway, or done any material damage to people or property in the air or on the ground. At the highest level, Zipline’s safety goal is to minimize the occurrences of accidents as we conduct our operations, both commercially and in testing. Zips are highly-automated fixed-wing small UAS designed by Zipline for airborne delivery of internally-carried packages. The Zip propulsion system consists of twin electric motors with three bladed propellers arranged in a co-axial tractor-pusher configuration. Zips are launched from a Zipline facility, called a Nest, using an electronic launcher, fly pre-planned routes to and from a Delivery Site, and return to the Nest for recovery via an automated arresting line system.
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