Regulatory Update: FAA Sets New Rules Governing Drone Registration

Written by M. Sean High – Staff Attorney

On December 14, 2015, the U.S. Federal Aviation Administration (FAA) announced an interim final rule (IFR) regulating the registration of drones with the stated purpose of providing “an alternative process that small unmanned aircraft [drone] owners may use to comply with the statutory requirements for aircraft operations [49 U.S.C 44102].” As a result, under IFR, beginning December 21, 2015, in addition to the current paper-based drone registration system (14 CFR part 47), FAA is required to provide an online web-based drone registration system (14 CFR part 48).

IFR applies to drones “weighing less than 55 pounds and more than 0.55 pounds (250 grams) on takeoff, including everything that is on board or otherwise attached to the aircraft and operated outdoors in the national airspace system.”  According to IFR, a drone owned prior to December 21, 2015 must be registered by February 19, 2015.  Comparably, a drone acquired after December 21, 2015 must be registered prior to that drone’s first outdoor flight.  All drone owners age 13 and older must register and if the owner is less than 13 years of age, then the drone must be registered by a person who is at least 13 years of age. 

Under IFR, FAA is to charge drone owners a $5 per drone registration fee.  Drone registration must be renewed every three years with a $5 renewal fee per drone.  Significantly, under IFR, failure to register a drone could result in civil penalties up to $27,500 and/or criminal penalties of up to $250,000 in fines (18 U.S.C. 3571) and/or imprisonment up to 3 years (49 U.S.C. 46306). 

Regulatory Update: FDA Approves Genetically Engineered Chicken

Written by M. Sean High – Staff Attorney

On December 8, 2015, the U.S. Food and Drug Administration (FDA) approved a genetically engineered (GE) chicken designed to produce eggs to be used in the manufacturing of a drug intended to treat the human enzyme disease lysosomal acid lipase deficiency (LAL-D).

LAL-D is a rare (and potentially fatal) disease that causes the build-up of fats within the tissue cells of multiple organs including the heart, liver, and spleen.  According to the pharmaceutical manufacturer Alexion Pharmaceuticals Inc. (Alexion), when LAL-D is present in infant patients (known as Wolman disease) there is currently a nearly 90% mortality rate; when LAL-D is present in pediatric and adult patients (known as cholesteryl ester storage disease) “with a clinical biopsy assessment, nearly 50% progress to fibrosis, cirrhosis, or liver transplant within 3 years of symptom onset.” Consequently, Alexion sought FDA approval for Kanuma, the company’s enzyme replacement therapy drug designed to combat LAL-D. 

Under Alexion’s manufacturing of Kanuma, GE chickens are raised so as to “produce a recombinant form of human lysosomal acid lipase (rhLAL) protein in their egg whites.” In turn, the rhLAL egg whites are to be purified and refined into the LAL-D fighting drug Kanuma.

FDA stated that the GE chickens and their eggs do not pose a human health risk because neither will be permitted to enter the food supply.  Importantly, FDA noted that their approval will “not cause a significant impact on the environment, because the chickens are raised in highly secure facilities.