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. 

Understanding Pennsylvania’s Recreational Use and Water Act (RULWA) –Part II: Meeting the Requirements

Written by M. Sean High – Staff Attorney

Under the Pennsylvania Recreational Use and Water Act (RULWA) (68 P.S. §§ 477-1 to 477-8), in some situations, landowners are provided with an immunity defense against negligence.  In order to receive the benefits of RULWA, however, certain requirements must be met.

Who is entitled to RULWA protection?

RULWA applies to landowners that allow the public access to their (qualifying) land, free of charge, for recreational use.  Under RULWA, the owner of the land means anyone who is “the possessor of a fee interest, a tenant, lessee, occupant or person in control of the premises.” If the owner of an easement exercises sufficient control over the easement (such as a utility company actively maintaining service roads), the easement owner is entitled to invoke RULWA as an immunity defense. 

What types of land qualify under RULWA?

Under RULWA, the land that qualifies for protection includes, “land, roads, water, watercourses, private ways and buildings, structures and machinery or equipment when attached to the realty.” When determining what land qualifies under this definition, courts look at the following factors: “nature of area in question; type of recreation offered in area; extent of areas development; and character of areas development.

While the statute does not make a distinction between improved and unimproved lands, the Pennsylvanian courts have consistently ruled that improved lands (those altered from their original state) do not qualify for RULWA protection. For example, a lacrosse field used for athletic competition and a playground were not entitled to RULWA protection because in all three instances, the land in question had been improved.  Conversely, the courts have determined that an undeveloped city field used for flag football and an earthen embankment near a public pavilion were largely unimproved and entitled to RULWA protection.

What is considered recreational use under RULWA?

According to RULWA, a recreational purpose “includes, but is not limited to:  hunting, fishing, swimming, boating, recreational noncommercial aircraft operations or recreational noncommercial ultralight operations on private airstrips, camping, picnicking, hiking, pleasure driving, nature study, water skiing, water sports, cave exploration and viewing or enjoying historical, archeological, scenic, or scientific sites.”

Because the list was not designed to be exhaustive, but serves as a guide, the courts are often called upon to determine whether certain activities not on the list qualify as recreational purpose.  Accordingly, courts have found that baseball, softball, bicycling, “four-wheeling,” and bingo are all recreational purposes within the intended meaning of RULWA.    

Understanding Pennsylvania’s Recreational Use and Water Act (RULWA) –Part I: The Duty of Care

Written by M. Sean High – Staff Attorney

In 1966, the Pennsylvania General Assembly enacted the Recreational Use of Land and Water Act (RULWA).  According to the statute (68 P.S. §§ 477-1 to 477-8), the purpose of RULWA “is to encourage owners of land to make land and water areas available to the public for recreational purposes by limiting their liability.” 

What does RULWA do?

RULWA provides a landowner with a potential immunity defense against claims that an individual was injured on a property as a result of the landowner’s negligence.  Landowner negligence occurs when a landowner fails to exercise the same level of care that a reasonably prudent and careful person would exercise under similar circumstances.  Different circumstances require landowners to exercise different levels of care towards the people that enter their property.  RULWA allows landowners the possibility of reducing the level of care owed whenever their land is made available to the public, free of charge, for recreational purposes.

What are the levels of care landowners owe those that enter their land?

When someone enters land without the consent of the landowner, that person is considered a trespasser.  Landowners normally owe this uninvited individual the low duty of care not to engage in any willful, wanton, or reckless conduct that could cause harm to the trespasser.  Nonetheless, if a landowner discovers or tolerates trespassers, the landowner then has an elevated duty to either warn the trespassers of known, hidden, man-made dangers or to make the premises safe.  For example, if a landowner discovers a foot path or litter near a section of a property used as a rifle range, the landowner may need to erect a sign warning of the potentially dangerous condition. 

Child trespassers require landowners to exercise a level of care greater than that owed to standard trespassers.  Known as the “Attractive Nuisance Doctrine,” children are considered unable to resist (or comprehend the danger of) things such as swimming pools, heavy machinery, or construction sites.  As a result, landowners have a duty to take reasonable precautions to protect child trespassers against the dangers of an attractive nuisance.  Often, this duty is fulfilled through erecting a secured fence around the danger. 

Generally, landowners that open their property to the public have a heightened duty of care towards the individuals that enter the property.  If a landowner invites persons onto the land, and the landowner receives no economic benefit, the invited persons are known as licensees.  A landowner has a duty of care to warn licensees of all known dangers on the property.  If the landowner invites persons onto the land (expressly or implied) for the economic benefit of the landowner, those invited persons are known as invitees. A landowner owes invitees a duty of protection and must inspect the land for dangerous conditions and warn the invitees of all known dangers on the property, and in certain situations, remedy the dangerous conditions.

RULWA provides qualifying landowners with an exception to the general duty of care owed towards those that enter their land.  If a qualifying property is made available to the public, free of charge, for recreational purposes, under RULWA, the landowner does not owe a duty to keep the property safe for the recreational users or to warn the recreational users of dangerous conditions.  In essence, RULWA only requires that landowners treat recreational land users with the same low duty of care that is owed to a trespasser (to not engage in willful, wanton, or reckless conduct that could cause harm to the recreational user). 

Vermont Farm Agrees to Settlement with DOJ Regarding Tainted Animals Sold for Human Consumption

M. Sean High – Staff Attorney

One day after the Department of Justice (DOJ) filed a complaint for permanent injunction to prevent a Vermont dairy farm’s use of unauthorized animal drugs in animals sold for human consumption, the parties filed an agreed upon settlement.

On December 7, 2015, on behalf of the United States of America, DOJ filed a complaint in the United States District Court for the District of Vermont requesting a permanent injunction against Correia Farm Limited Partnership for allegedly violating the Federal Food, Drug, and Cosmetic Act (FDCA) by administering unapproved new animal drugs which resulted in unsafe drug residue levels in animals slaughtered for human consumption.   

On December 8, 2015, the parties filed a settlement consent decree for permanent injunction.  As part of the settlement, Correia Farm Limited Partnership agreed to a heightened level of Federal Drug Administration (FDA) oversight and scrutiny of their operation and to cease operations until the implementation of FDA approved “record-keeping and operational protocols designed to ensure consumer safety.” Significantly, Correia Farm Limited Partnership agreed not to resume food production (excluding milk) until an FDA determination that the operation’s manufacturing practices have come into compliance with the law.  

The agreed upon consent decree for permanent injunction now awaits judicial approval from the U.S. District Court for the District of Vermont.

WTO Arbitrator Rules against U.S. COOL Law

Written by M. Sean High – Staff Attorney

On December 7, 2015, the U.S. Country of Origin Labeling (COOL) law suffered a significant blow as a World Trade Organization (WTO) arbitrator determined that COOL violated international trade obligations, and awarded Canada and Mexico the right to impose over $1.2 billion in retaliatory tariffs against U.S. exports.

Under COOL, certain food retailers (such as supermarkets and grocery stores) are required to provide the name of the country of origin on the labels on specific food products including “muscle cut and ground meats: beef, veal, pork, lamb, goat, and chicken; wild and farm-raised fish and shellfish; fresh and frozen fruits and vegetables; peanuts, pecans, and macadamia nuts; and ginseng.” 

According to Canada and Mexico, through the enactment of COOL, the U.S. violated Article 2.1 of the Agreement on Technical Barriers and Trade (TBT Agreement) requiring that all signatory members (which include the U.S., Canada, and Mexico) “shall ensure that in respect of technical regulations, products imported from the territory of any Member shall be accorded treatment no less favourable than that accorded to like products of national origin and to like products originating in any other country.” Canada and Mexico contended that by requiring country of origin labeling, the two nations were “accorded less favourable treatment of imported livestock than to like domestic livestock,” and because of this treatment, the U.S. failed to carry-out its TBT Agreement obligations.

During the arbitration proceedings, Canada and Mexico’s asserted that because of COOL, they each experienced “export revenue losses” and “revenue loss as a result of domestic price suppression.” Canada claimed annual revenue losses totaling $1,054,729,000 and Mexico claimed annual revenue losses totaling $227,758,000.  Ultimately, the presiding arbitrator agreed with Canada and Mexico and awarded each nation the ability to impose retaliatory tariffs on the U.S. commensurate with their claimed annual revenue losses.  

Following the WTO arbitral ruling, U.S. House Agriculture Committee Chairman K. Michael Conaway (R-TX) stated, “We have known for some time that the Country of Origin Labeling law violates our international trade obligations.” Significantly, on June 10, 2015, legislation sponsored by Chairman Conaway that would repeal COOL (H.R. 2393), passed the U.S. House of Representatives by a vote of 300-131.  Currently, H.R. 2393 awaits action by the U.S. Senate. 

EU Extends Measures to Combat Highly Pathogenic Avian Influenza

Written by M. Sean High – Staff Attorney

Effective November 30, 2015, the European Union (EU) passed Implementing Decision 2015/2225.  The legislation, which extends current measures intended to protect against outbreaks of highly pathogenic avian influenza, coincides with recent avian influenza detections in France. 

Extended under 2015/2225 was Decision 2005/734/EC; a biosecurity measure designed to 1) reduce the spread of highly pathogenic avian influenza from wild birds to domestic poultry; and 2) provide a system for early detection of the disease.  Also extended under 2015/2225 was Decision 2006/415/EC; a measure designed to protect EU member states in the event of an outbreak of highly pathogenic avian influenza.

According to the text of 2015/2225, because of recent outbreaks and the serious risks associated with avian influenza, “[i]t is therefore appropriate to continue mitigating the risks posed by highly pathogenic avian influenza by maintaining biosecurity measures, early detection systems and certain protection measures in relation to future outbreaks of that disease in poultry flocks in the Union.”

All measures extended by 2015/2225 were scheduled to expire December 31, 2015 and have been extended until December 31, 2017.