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.

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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 in 2016 and 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).

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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, , 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.

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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. All aspects of the Zip UAS are designed, manufactured, and operated by Zipline. Zipline is actively working with the FAA on aircraft type certification for the Zip UAS and remains engaged on a weekly basis with the FAA on that effort. Additional details on the Zip are as follows:

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Wingspan: 10 ft 10 in Length: 6 ft 2 in Height: 2 ft Control Surfaces: 2 Ailerons, 2 Flaperons, 4 Ruddervators (V-tail/split control surfaces) MTOW: 46 lbs Airspeed (Cruise): 56 knots Max Payload Weight: 3.9 lbs Service Range with payload: 100 mi (50 mi each way) Propulsion: Twin electric motors (only one required) Power Type: Rechargeable Lithium-ion battery Maximum Endurance: 2 hours Service Ceiling (MSL): 12,000 ft (400’ AGL maximum proposed operating altitude)

The Zip is designed and engineered to prioritize safety and reliability. The flight critical systems of each Zip have been made redundant in several areas. Zips have dual motors and are able to continue flight back to a Nest under the power of a single motor. Zips also have redundant control surfaces on each wing and on each ruddervator such that a Zip is capable of flying safely

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even after the failure of any control surface actuator. Similarly, the GNSS system onboard each Zip has two independent and redundant receivers and the command and control system has separate line of sight, cellular, and satellite radios. Additionally, the Zip is electrically powered via a custom lithium ion battery capable of supplying redundant power with single fault tolerant battery design including having been designed and tested to be fault tolerant to single cell thermal runaway events.

As an additional layer of safety, each Zip has a Paraland System that manually or automatically deploys a parachute and lands the Zip if the Zip enters a critical state. For example, the Paraland System automatically deploys if a Zip leaves its permitted flight route, exceeds a maximum allowed velocity, or experiences a power loss, software failure, or loss of both motors. The Paraland System is mechanically and electrically isolated from a Zip’s avionics, and runs on an independent processor with an independent power supply. The independent processor and power supply enable the Paraland System to remain operative even when there is total failure of a Zip’s avionics or battery system. When triggered, the Paraland System rapidly terminates flight and limits a Zip’s rate of descent, thus reducing the risk to objects and people on the ground, as well as to the Zip’s cargo.

Moreover, the fuselage of the Zip is covered in deformable crash foam (of a similar type to what is commonly used in bicycle safety helmets). This frangible design and use of lightweight materials provides a measure of energy absorption in the event of an impact to further reduce the possibility of injury.

II. RELIEF SOUGHT AND EXTENT OF THAT RELIEF

Zipline seeks a limited exemption from 14 C.F.R. § 107.36 – the prohibition on carriage of hazardous materials – in order to permit Zipline UAS to carry (1) approximately one (1) pound of dry ice as a refrigerant in packaging for the COVID-19 vaccine, and (2) a lithium battery contained in a data logging system to ensure the temperature remains within acceptable limits when operating on two closed test ranges located in rural California controlled by Zipline and where Zipline is currently conducting operations under 14 C.F.R. § 107 and related waivers.6 The first test site is located in Yolo County, California on a rural 7,600-acre private ranch, and the second test site is located approximately 10 miles outside of Half Moon Bay, California on a rural 100-acre private ranch. Neither site has any public roads, and both are protected by fencing, locked gates, and are otherwise access controlled by Zipline. No unauthorized personnel are permitted within the test

6 See Certificate of Waiver or Authorization No. 107W-2020-04037 (Dec. 4, 2020) (granting Zipline waivers to 14 C.F.R. §§ 107.29 (Daylight operation), 107.31 (Visual line of sight aircraft operation), 107.33(b) and (c)(2) (Visual observer), and 107.35 (Operation of multiple small unmanned aircraft). To the extent necessary, Zipline requests that it be allowed to conduct operations under this grant of exemption combined with these waivers.

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site. The purpose of the test flights is to ensure and confirm that the container can be carried in a safe and secure manner without compromising the dry ice and lithium battery that are essential to maintain the cold temperature of the COVID-19 vaccine while in transit.

III. BENEFIT TO THE PUBLIC AS A WHOLE

The COVID-19 pandemic has sickened millions and killed more than 1.7 million people, including 315,000 Americans.7 In December 2020, the FDA authorized the use of two vaccines from Pfizer and Moderna.8 This remarkable milestone is, however, just the beginning; the nation and the world now face the challenge of equitable and efficient distribution of the vaccine.

Efficient distribution of vaccines by all means, including by contact-less aerial delivery, is essential to stem the effects of the pandemic. Similarly critical is the development and implementation of an ultra-cold supply chain capable of safely storing and transporting vaccines at temperatures as low as -94 degrees Fahrenheit. This challenge is particularly acute for rural and remote communities.

Rural populations are the most vulnerable to COVID-19 and among the most in need of a vaccine. As Alan Morgan, Chief Executive of the National Rural Health Association, recently said, “Hundreds of rural, small towns all across the U.S. have a higher percentage of elderly, low- income [residents], [and] a higher percentage of the community with multiple chronic health issues.”9 As of late October, “about one in four deaths from the virus is recorded in a rural county.”10

Rural areas of the United States in particular face “significant disparities in access to health care, such as fewer providers and reduced access to pharmacies.”11 Most rural hospitals “can’t afford these high-end [ultra-cold freezer] units, meaning health workers and residents in those

7 Johns Hopkins Coronavirus Resource Center, https://coronavirus.jhu.edu/map.html (last accessed Dec. 23, 2020); United States COVID-19 Cases and Deaths by State, CDC Covid Data Tracker, https://covid.cdc.gov/covid-data- tracker/#cases_casesper100klast7days (last accessed Dec. 21, 2020). 8 FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine, FDA News Release (Dec. 18, 2020), https://www.fda.gov/news-events/press-announcements/ fda-takes-additional-action-fight-against-covid-19-issuing-emergency-use-authorization-second-covid. 9 Olivia Goldhill, “‘We’re being left behind’: Rural hospitals can’t afford ultra-cold freezers to store the leading Covid- 19 vaccine,” STAT News (Nov. 11, 2020), https://www.statnews.com/2020/11/11/rural-hospitals-cant-afford-freezers- to-store-pfizer-covid19-vaccine/. 10 Lauren Leatherby, “The Worst Virus Outbreaks in the U.S. Are Now in Rural Areas” New York Times (Oct. 22, 2020), https://www.nytimes.com/interactive/2020/10/22/us/covid-rural-us.html. 11 Alyssa Yancey, “UofSC Center Improving Access to Health Care in Rural Communities,” University of South Carolina (Nov. 17, 2020), https://www.sc.edu/uofsc/posts/2020/11/healthcare_rural_health.php#.YADNtthKgdU.

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communities may have difficulty getting the shots.”12 State officials estimate that $1.2 billion in emergency federal funding may be needed to solve the problem.13

The Pfizer vaccine in particular must be administered in two doses, given 21 days apart. It will be delivered in special dry ice-packed boxes holding 1,000 to 5,000 doses. Because many hospitals lack the ultra-low freezers required to keep the vaccine viable for up to six months, all doses must be administered within 15 days, assuming a plentiful supply of dry ice and opening the special boxes no more than twice a day. Otherwise, all 1,000 to 5,000 doses must be kept in a standard medical freezer and used within five days.14 Rural health officials have “urged Pfizer to figure out a way to package its vaccine in smaller shipments so it could be delivered directly to rural hospitals.”15 According to Imelda Garcia, the associate commissioner for the Texas Department of State Health Services’ Division for Laboratory and Infectious Disease Service, “If Pfizer comes out and says they’re going to provide doses of 25 instead of 1,000, that’s a game- changer”16

Delivery by small unmanned aircraft is a key component of such an integrated and comprehensive ultra-cold distribution system that can reach rural and remote communities with the precision and quantities they need. Affording Zipline the exemption authority to conduct tests of small UAS carrying a limited quantity of hazardous material as described in this petition is critical to demonstrating that drones can safely contribute to vaccine delivery.

IV. GRANTING THE EXEMPTION WOULD NOT ADVERSELY AFFECT SAFETY

Zipline’s requested exemption is limited to flight tests of its small UAS on a closed range, conducted in the first quarter of 2021. It is thus limited by location and time, and by the very small amount of hazardous material carried on board the aircraft. The requested exemption is very limited in scope: exercisable only in a test flight environment. Once the tests are completed, Zipline has no plans to use the exemption for actual deliveries. Rather, Zipline plans to seek a limited Hazmat “will carry” authority in its OpSpecs for 14 C.F.R. Part 135 operations to allow our UAS to carry the dry ice and lithium battery in onboard containers used to deliver COVID-19

12 Olivia Goldhill, “‘We’re being left behind’: Rural hospitals can’t afford ultra-cold freezers to store the leading Covid-19 vaccine,” STAT News (Nov. 11, 2020), https://www.statnews.com/2020/11/11/rural-hospitals-cant-afford- freezers-to-store-pfizer-covid19-vaccine/. 13 Association of State and Territorial Health Officials and the Association of Immunization Managers, Congressional Emergency Funding Request (Oct. 15, 2020), https://www.astho.org/Federal-Government- Relations/Correspondence/ASTHO-AIM-Funds-for-Vaccination-Distribution-Letter/. 14 Carl O'Donnell, “The COVID-19 Vaccine Challenge You Might Not Have Known About.” The World Economic Forum (Nov. 11, 2020), https://www.weforum.org/agenda/2020/11/pfizer-vaccine-covid19-cornavirus-storage- hospital-healthcare/. 15 Isaac Arnsdorf et al., “Most States Aren’t Ready to Distribute the Leading COVID-19 Vaccine” ProPublica (Nov. 10, 2020), https://www.propublica.org/article/most-states-arent-ready-to-distribute-the-leading-covid-19-vaccine. 16 Id.

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vaccines. Because Zipline does not yet have Part 135 operating authority, Zipline must operate under 14 C.F.R. Part 107 in order to accomplish necessary flight tests.

Flying with dry ice is not a novel concept. In fact, FAA and airlines permit the carriage of up to 5.5 pounds of dry ice that is properly packaged, vented, and marked and with airline approval.17 Likewise, air transportation of the small lithium batteries contained in the equipment subject to this petition has become so routine that the batteries are excepted from most of the hazardous materials regulations.18 In recognition that the public health emergency created by the pandemic merits the transport of COVID-19 vaccines by air, FAA has issued information and recommendations to manned aircraft operators about carriage of large quantities of dry ice.19 Nor would FAA granting an exemption from 14 C.F.R. § 107.36 to allow a small UAS operator to carry Hazmat be precedential.20 Here, the individuals packaging and loading the dry ice on the Zips will be trained in the proper handling, packaging, and loading of the small UAS, and the very small amount of dry ice would be carried in a purpose-built container as the only cargo onboard an aircraft flying highly controlled test operations in remote areas.

V. SUMMARY FOR PUBLICATION IN THE FEDERAL REGISTER (IF NECESSARY)

Zipline requests a limited exemption from 14 C.F.R. § 107.36 in order to carry (1) approximately one pound of dry ice, and (2) lithium batteries contained in a data logging system in a cargo container on board small unmanned aircraft for the purpose of testing the capability of the aircraft to safely carry the COVID-19 vaccine as part of an end-to-end ultra-cold chain vaccine delivery system.

Petitioner Point of Contact: Zipline International Inc. ATTN: Jeffrey Immel 333 Corey Way South San Francisco, CA 94080 E-mail: [email protected]

17 Dry Ice, TSA, https://www.tsa.gov/travel/security-screening/whatcanibring/items/dry-ice (last accessed Dec. 21, 2020). 1849 C.F.R. §173.185(c). Notably, UAS, including those operated by Zipline, are powered by lithium batteries. 19 FAA, Transportation of COVID-19 Vaccines Requiring Large Quantities of Dry Ice, SAFETY ALERT FOR OPERATORS (SAFO) 20017 (Dec. 10, 2020), https://www.faa.gov/other_visit/aviation_industry/airline_operators/airline_safety/safo/all_safos/media/2020/SAFO 20017.pdf. 20 See, e.g., In re Prairie Sky UAV LLC, Exemption No. 18140, Dkt. No. FAA-2018-0757 (Mar. 6, 2019) (exemption granted – without publication of summary – to carry and dispense agricultural pesticides); In re Hart Media LLC, Exemption No. 18070, Dkt. No. FAA-2018-0878 (Nov. 30, 2018) (same); In re Drone Seed Co., Exemption No. 17261, Dkt. No. FAA-2016-9247 (Mar. 17, 2017) (exemption granted to carry agricultural pesticides).

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Telephone: +1-415-993-0604

* * *

In summary, Zipline respectfully petitions FAA to expeditiously grant its exemption request in order to accomplish necessary tests of small UA carrying dry ice. Doing so advances aviation safety and public health, and is in the public interest. Expedited processing of the request, including not publishing the petition for public comment, is likewise in the public interest. The relief sought is limited, timely filed, non-precedential, and urgent.

Please do not hesitate to contact me if you have any questions or concerns.

Sincerely,

Jeffrey Immel Head of U.S. Regulatory