Animal agriculture, like other animal-related industries, is a constantly evolving enterprise, informed by results from scientific studies focused on the best methods to raise livestock so as to minimize animal discomfort and disease.

With increasing concerns about the impacts on antibiotic resistance resulting from the use of antibiotics in livestock, methods to keep livestock healthy without relying on antibiotics has become the focus of scientific research.

Hence, the ability to modify animal genes to protect them from disease infection has been an area of increased interested.

Genus, a world-leading animal genetics company, recently announced “the discovery of the first pig resistant to Porcine Respiratory and Reproductive Syndrome virus (‘PRRSv’)[1] in collaboration with the University of Missouri. An exclusive global license has been signed enabling Genus to develop and commercialise the technology.”

As reported on USDA’s website[2]

PRRSV is the etiologic agent of PRRS, an economically devastating, pandemic disease of swine that is typically characterized by reproductive failure in breeding herds and respiratory problems and growth retardation in growing pigs.  Two PRRS outbreaks were first reported in the late 1980s in North America and central Europe.  The disease is now found in most pig-producing countries and affects the swine industry and food safety worldwide, causing enormous economic losses each year.  In the US, the annual loss due to PRRS is estimated to exceed $500 million.  Over the last decade, this genetic/antigenic diversity of PRRSV has expanded continuously and rapidly, highlighting the dynamic nature of PRRSV evolution and epidemiology.

Using gene editing technology, Genus and its subsidiary the Pig Improvement Company (PIC) reportedly made “small changes . . . to inactivate a single gene from the pigs that produces a protein, known as CD163, [which] the PRRS virus requires for infection to occur.”

The results allow the production of PRRSv resistant pigs.

As described on Genus’ website:

“Using precise gene editing, the University of Missouri was able to breed pigs that do not produce a specific protein necessary for the virus to spread in the animals.  The early stage studies conducted by the University demonstrate these PRRSv resistant pigs, when exposed to the virus, do not get sick and continue to gain weight normally.  Genus will continue to develop this technology, and we expect it will be at least five years until PRRS resistant animals are available to farmers.”

Since there is no cure for PRRSV and the disease results in “the suffering or death of millions of pigs and piglets each year,” this type of innovative advance in science is considered a breakthrough.

[1] While antibiotics are not effective in treating viruses like PRRSV, such infections are often accompanied by secondary bacterial infections which are susceptible to targeted antibiotic treatment.

[2] This information is from Utah State University’s submission to USDA’s Current Research Information System (CRIS).

USDA, authorized and tasked with enforcing the humane treatment of horses pursuant to the Horse Protection Act, has published amendments to its regulations pursuant to the Act.

According to a 2010 Audit Report by USDA’s Office of Inspector General:

“APHIS’ program for inspecting horses for soring is not adequate to ensure that these animals are not being abused. At present, horse industry organizations hire their own inspectors (known as designated qualified persons (DQP)) to inspect horses at the shows they sponsor. However, we found that DQPs do not always inspect horses to effectively enforce the law and regulations, and in some cases where they do find violations, they deliberately issue tickets to friends or family members of responsible individuals so that the responsible person could avoid receiving a penalty for violating the Horse Protection.”

APHIS agreed with the findings of this report and proposed regulations that would dramatically amend its regulations—not only removing the authority of horse industry organizations to train designated qualified persons, and reassigning that responsibility to APHIS—but also amends the regulations “to prohibit use of pads, substances, and action devices on horses at horse shows, exhibitions, sales, and auctions.” See 81 FR 49112, July 26, 2916.

The Tennessee Walking Horse Breeders’ and Exhibitors’ Association (TWHBEA), who will be most affected by the proposed regulations have expressed concerns about the proposed rule, warning that:

“[t]he proposed rule by the United States Department of Agriculture that would eliminate the use of any pad, action device or hoof band as well as eliminate all self-regulation will have devastating impacts. The demands on horse show management will be costly and create an unnecessary hassle and the demands on exhibitors to enter horses, regardless of the division will be prohibitive as well. Horse shows in many cases will cease to exist.

The proposed rule is clearly an overreach, typical of today’s Washington, and an overt effort to bypass Congress. In order to appease radical animal rights organizations, USDA is refusing to objectively look at the facts and instead implementing rules that are not based in science or reality. Veterinary experts at Auburn University and the University of Tennessee have proven that action devices and pads do not harm horses.”

Instead “TWHBEA is calling on USDA to assemble a group of Equine Specialists to determine objective tests and end more than forty years of conflict,” adding that:

“TWHBEA is currently funding veterinary research in order to obtain objective, scientific tests for our show horses. Changing inspectors and eliminating our show horse will do nothing to help the welfare of our horse and will crush hundreds of civic clubs across the country who depend on our shows for fundraising.”

The American Association of Equine Practitioners, whose mission is “to improve the health and welfare of the horse, to further the professional development of its members, and to provide resources and leadership for the benefit of the equine industry,” is in favor of the proposed regulations.

 

“The AAEP is extremely pleased with the USDA’s work in proposing regulation changes to end the inhumane act of soring, which is one of the most significant welfare issues affecting any equine breed or discipline in the United States.

As doctors of veterinary medicine, we have previously recommended the use of only veterinarians to inspect horses at shows for evidence of soring, as well as a ban on action devices and performance packages. Both of these items are included in the USDA’s proposed rule changes.

Soring is an intentional, cruel act which must end. The AAEP will continue to support the Prevent All Soring Tactics (PAST) Act and work to eliminate this practice.”

In USDA’s “Regulatory Impact Analysis & Analysis in support of Certification that the Rule will not have a Significant Economic Impact on a Substantial Number of Small Entities” the agency concluded that the proposed  “rule will not have a significant economic impact on a substantial number of small entities.”

However, the agency also invited comments that refute that conclusion, which provides the TWHBEA or others negatively affected by this proposed regulation the opportunity to inform USDA about potential unintended consequences of its rule.

 

 

 

 

 

 

FDA, gearing up for the implementation of the Veterinary Feed Directive (VFD), recently “issued a letter reminding retail establishments that sell medically important antimicrobials for use in feed or water for food animals that the marketing status of those products will change from over-the-counter (OTC) to prescription (Rx) or to veterinary feed directive (VFD) at the end of calendar year 2016.”

As reported in the Daily Herald, those servicing livestock producers in Utah have also been trying to spread the word:

“Local veterinarians, feed suppliers and livestock producers gathered in Lehi on Thursday to learn how the federal feed directive, which goes into effect on Jan. 1, will affect their operations.

The meeting is just one of a series of meetings being held across the state to make sure livestock producers aren’t taken by surprise when the new directive takes effect. It is expected to affect almost everyone who raises animals for human consumption — from 4-Hers to turkey farmers to bee keepers.”

The VFD sets forth “the process for authorizing use of VFD drugs and provides a framework for veterinarians to authorize the use of medically important antimicrobials in feed when needed for specific animal health purposes” as reported by Lydia Zuraw on JUNE 3, 2015 at Food Safety News.

FDA announced that the final rule is:

“an important piece of the agency’s overall strategy to promote the judicious use of antimicrobials in food-producing animals. This strategy will bring the use of these drugs under veterinary supervision so that they are used only when necessary for assuring animal health.”

Notably, as previously discussed here, the rule memorializes the concept that veterinarian may only prescribe antibiotics to animals “within the context of a veterinarian-client-patient relationship (VCPR), which includes sufficient knowledge of the animal, visits to the farm, and follow-up evaluation or care.”

While many states include that requirement in state veterinary medical practice acts, not all states include a definition of or specifications for the “veterinarian-client-patient relationship.”  (See table of state laws compiled by AVMA).

The VFD will require veterinarians to follow state-defined VCPR requirements as long as the state requirements include the key elements in the final VFD.

FDA requires:

“the veterinarian engage with the client (i.e., animal producer or caretaker) to assume responsibility for making clinical judgments about patient (i.e., animal) health, have sufficient knowledge of the animal by conducting examinations and/or visits to the facility where the animal is managed, and provide for any necessary follow-up evaluation or care.”

However, “where the FDA determines that no applicable or appropriate state VCPR requirements exist, veterinarians will need to issue VFDs in compliance with federally defined VCPR requirements.”

FDA issued a draft revised guidance for industry, “General Principles for Evaluating the Human Food Safety of New Animal Drugs Used In Food-Producing Animals” in July 2016 that “described the type of information that the Food and Drug Administration’s (FDA’s) Center for Veterinary Medicine (CVM) recommends sponsors provide [the agency] to address the human food safety of new animal drugs used in food-producing animals.”

In addition to proving that drugs are safe and efficacious in the targeted livestock species, drug companies (sponsors) face increasing hurdles to prove that “food derived from treated animals is safe for human consumption.”

FDA has already begun implementing other changes to “the way medically important antibiotics have been used in animal agriculture for decades.” See FDA’s Guidance #213.

As reported on its website, FDA explains:

“[o]nce the changes are fully implemented, it will be illegal to use these medically important antibiotics for production purposes, and animal producers will need to obtain authorization from a licensed veterinarian to use them for prevention, control or treatment of a specifically identified disease.”

Food animal veterinarians and livestock farmers are concerned about their ability to treat animals with antibiotics appropriately when needed. In response,

“[t]he FDA acknowledges the important role medically important antimicrobials play in treating, controlling, and preventing disease in food-producing animals. However, the agency has been actively engaging veterinary organizations, animal producer organizations and other stakeholders to express our position that medically important antibiotics labeled for continuous or undefined durations of use is not consistent with judicious use principles, as outlined in previously-released guidance documents.”

In “General Principles for Evaluating the Human Food Safety of New Animal Drugs Used In Food-Producing Animals” FDA “provides, in one document, an overview of the overall process for the human food safety evaluation of new animal drugs used in food-producing animals, including:

  • Determining an acceptable daily intake (ADI);
  • Calculating safe concentrations;
  • Assignment of a tolerance;
  • Calculation of a withdrawal period and a milk discard time; and
  • Evaluation of carcinogenic compounds.”

In addition to analyzing the appropriate withdrawal times for meat, milk, and eggs, the agency evaluates the proposed drugs for their potential to create additional pressures on antibiotic resistance in humans.

However, FDA has identified drugs that may not have to undergo this analysis if it (and its metabolites and excipients) are not:

  • “regularly considered to have properties that would exert pressure towards the emergence or selection of bacteria of public health concern;
  • used to treat zoonotic gastroenteritis or other bacterial diseases in humans;
  • under development to treat bacterial diseases in humans; or
  • indicated for a bacterial disease in food-producing animals (i.e., indication is instead antifungal, antiprotozoal, anthelminthic, etc.).”

With the emergence of new methods of disease treatment and  prevention (using, for example, genetically immune livestock) hopefully veterinarians and farmers will not have to rely on antibiotics to treat animals and keep them healthy, since it will be increasingly difficult to obtain and retain the ability to use these drugs in livestock.

Fox Rothschild’s has launched an Animal Law practice, led by attorney and licensed veterinarian Nancy E. Halpern, D.V.M., and made up of lawyers experienced in defending the rights of businesses and people to own and use animals humanely. This multi-disciplinary practice is a one-stop shop for animal-related business, providing the full range of corporate law services — including entity formation, financing, securities, ownership transition and exit strategy — as well as regulatory assistance, patent services and litigation, among many others. Visit the page to learn more about the services we provide and the people in the practice.

The Plaintiffs who sued SeaWorld “alleging misrepresentations about its treatment of orcas” will have survived SeaWorld’s motion to dismiss if they cure the defects the Court identified in the Order Granting, In Part, And Denying, In Part, Motion To Dismiss, With Leave To Amend And Setting Case Management Conference, entered August 1, 2016.

Plaintiffs assert[ed] claims for (1) violations of California’s false advertising law, Business and Professions Code sections 17500, et seq. (the “FAL claim”); (2) violations of California’s unfair competition law, Business and Professions Code sections 17200, et seq. (the “UCL claim”); and (3) violation of California’s Consumer Legal Remedies Act, California Civil Code section 1750, et seq. (the “CLRA claim”) based on their allegations that: SeaWorld’s advertisements:

“misleadingly creates the perception that orcas as a species are generally benefited by SeaWorld’s rehabilitative programs, scientific studies, and educational activities, and that the individual orcas it holds in captivity are as healthy and as stimulated as their wild counterparts . . .”

The Court accepted the factual allegations of the first amended complaint (the active pleading) as true, but in many instances found them inadequate to withstand SeaWorld’s motion.

The Court granted SeaWorld’s motion to dismiss in part but granted Plaintiffs liberal leave to amend the complaint finding that they could possibly correct the deficiencies noted.

Specifically:

  1. The Court dismissed the CLRA claim, with leave to amend.
  2. The Court granted the Motion to Dismiss the UCL and FAL claims for lack of Article III standing to seek injunctive relief, with leave to amend.
  3. The Court granted, in part, Sea World’s Motion to Dismiss for failure to comply with Rule 9(b), with leave to amend.
  4. The Court granted, in part, SeaWorld’s Motion to Dismiss for lack of statutory standing with leave to amend.

SeaWorld also argued that Plaintiff’s claims “are barred by the First Amendments, but the Court, permitting SeaWorld to “renew this argument at a later date” denied the motion in part.

Plaintiffs have until August 22, 2016 to file their Second Amended Complaint.

The Virginia Department of Agriculture Department of Agriculture and Consumer Services has amended its Rules and Regulations Pertaining to a Pound or Enclosure to Be Maintained by Each County or City. The amendments are in the final adoption period which will end on August 24 2016 when the new regulations will be effective.

As reported on the Virginia Regulatory Town Hall website , the goals of the regulation are threefold:

  1. The protection of the public’s health, safety, and welfare with the least possible cost and intrusiveness to the citizens and businesses of the Commonwealth.
  2. The reduction of the incidence of animal diseases in pounds, so as to reduce the risk of spreading those diseases to animals outside of the shelters and to humans.
  3. The minimization of the cost of maintaining and operating shelters by providing, when the locality requests it, guidance on their design.

The previous regulation pertained only to public animal shelters. The amendments require both public and private animal shelters to provide the same standards of care.

As described in the summary of the regulatory changes:

“This action repeals the existing regulation that governs public animal shelters and replaces it with a regulation that governs both public and private animal shelters. The substantive changes in the replacement regulation (i) require animal shelters to provide each animal with an appropriate resting platform, bedding, or perch; (ii) require each shelter to have protocols that have been approved by a veterinarian for the medical treatment of animals, the control of infectious disease, and the management and care of neonatal and medically compromised animals; and (iii) require private animal shelters to have special housing for strays that are subject to a holding period.”

The importance of this regulatory change is far-reaching.

No matter the status of an animal shelter, animal rescue organization, or foster home, the standard of care provided to the animals therein should be equivalent.

It’s summertime!

Many of us are planning some time away from home. If you plan on taking your pets with you, the USDA just updated their website with important information about traveling internationally with your pet.

The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) has launched a new Web site devoted to international pet travel. Pets are often considered part of the family, but traveling with your pet isn’t as simple as just booking a flight or driving across the border. There may be very specific steps you and your veterinarian need to follow, as well as pet vaccinations, treatments, and/or testing that your veterinarian must document.

 

We know this process can be stressful. That’s why we designed a new Web site to help guide you and your veterinarian through each step. Some countries have pre-travel requirements that take advanced planning and time to complete, so it’s important to start the process early.

The website includes instructions about taking pet to other countries and bringing pets into the U.S.

APHIS explains its mission “is to protect the health and value of American agriculture and natural resources.”

To prevent the entry and spread of foreign animal diseases into our country, pets entering the United States from other countries may need to meet specific APHIS requirements.

In addition to federal requirements, airlines may have additional requirements for pet owners.

Don’t forget to bring along any medication, and the food your pet is used to eating if it is not available at your destination, to avoid gastrointestinal disorders.

Make sure your pet is properly identified and keep in mind that microchip technology and readers may not be reliable at your destination, so make sure your contact information is included on your pet’s collar.

USDA’s website also includes links to other federal agencies that have additional requirements for pet owners.

For example, the CDC has regulations that “require that dogs imported into the United States are healthy and are vaccinated against rabies before arrival into the United States. These requirements apply equally to all dogs, including puppies and service animals.”

 

Plan accordingly and be safe.

Animal rescue organizations and animal shelters have replaced pet stores as the primary source of dogs throughout the United States.

Unfathomably, concerns about the health of dogs imported from other states and countries are rarely discussed. Unsuspecting adopters could end up with dogs that have serious, sometimes fatal diseases.

For example, dogs that have been increasingly imported from Puerto Rico may be infested with heartworms and suffering from heartworm disease, which according to the AVMA is “a progressive, life-threatening disease.”

There are reportedly 100,000 stray dogs in Puerto Rico, where abandoning dogs is common and spaying and neutering is not the common practice.

According to “The Sato Project,” a nonprofit organization formed to rescue abandoned & abused dogs from Puerto Rico, heartworm infestation is widespread in Puerto Rico.

Roughly 70% of the dogs The Sato Project rescues are heartworm positive, requiring expensive and lengthy medical treatment.

The AVMA confirms that heartworm is prevalent in dogs in Puerto Rico:

There is a distinct geographic pattern for heartworm disease, with the highest prevalence of heartworm infection in 2015 occurring in the Southeastern states and Puerto Rico.

The American Heartworm Society whose “Mission is to lead the Veterinary Profession & the Public  in the understanding of Heartworm disease,,” explains that heartworm disease “is caused by foot-long worms (heartworms) that live in the heart, lungs and associated blood vessels of affected pets, causing severe lung disease, heart failure and damage to other organs in the body.”

Signs of heartworm disease may include a mild persistent cough, reluctance to exercise, fatigue after moderate activity, decreased appetite, and weight loss. As heartworm disease progresses, pets may develop heart failure and the appearance of a swollen belly due to excess fluid in the abdomen. Dogs with large numbers of heartworms can develop a sudden blockages of blood flow within the heart leading to a life-threatening form of cardiovascular collapse. This is called caval syndrome, and is marked by a sudden onset of labored breathing, pale gums, and dark bloody or coffee-colored urine. Without prompt surgical removal of the heartworm blockage, few dogs survive.

Heartworm is not the only disease of concern in dogs imported from Puerto Rico for adoption. Rabies cases in dogs from Puerto Rico have been diagnosed, as reported by the CDC:

During 2014, domestic animals accounted for 47.9% of all animals submitted for testing, but only 7.37% (n = 445) of all rabies cases reported, representing a decrease of 4.71% compared with the 467 reported in 2013.

Of the fifty-nine rabid dogs reported in 2014 . . . [m]ost of the rabid dogs were reported from Texas (n = 14 [23.7%]), Puerto Rico (12 [20.3%]), and Oklahoma (9 [15.2]).

While clearly there are abandoned, stray dogs in Puerto Rico in need of homes, these animals may harbor diseases that will decrease their longevity or require significant veterinary care and related expenses, that unwitting adopters may not be aware of.

Moving the unwanted stray dogs from Puerto Rico to adopters on the mainland will not stop the continued overpopulation on that island without more.

Animal rescue organizations like The Sato Project and Second Chance Animal Rescue importantly do not just remove dogs from Puerto Rico and offer them for adoption, they also educate local residents about the importance of responsible pet ownership, which includes preventing unplanned dog breeding by proper sterilization of owned dogs.  That still may not be enough to change the landscape on the island.

.At the same time, responsibly and purposely-bred dogs should not be banned to force pet owners to obtain dogs only from rescue sources.

A disabled woman, Ms. Rubin, has been denied the ability to purchase a unit in Kennedy House, Inc., a “residential cooperative building” with a no-pet policy, because she was unable to prove that her dog provides assistance for her claimed disabilities, as recently decided by the Commonwealth Court of Pennsylvania in Kennedy House Inc v Philadelphia Comn on Human Relations, 2016 WL 3667992 (Pa. Commw. Ct. July 11, 2016).

The opinion analyzes the burden of proof required by individuals claiming the need for a service or assistance dog in order to overcome a prohibition on pets in residential buildings.

In this case Kennedy House agreed that Ms. Rubin was suffering from a number of physical ailments and medical conditions that constitute a physical disability, but disagreed with the Philadelphia Commission on Human Relations (Commission) that had found Kennedy House had impermissibly discriminated against Ms. Rubin by denying her application to purchase a unit and live with her service dog, Mira, at the cooperative.

The Commonwealth Court reversed the Commission’s decision, rejecting the test used by the Commission, that an accommodation to a disabled individual is required if keeping the animal has “some relation to their disability” and instead held that there must be “a sufficient nexus between the disability described in the medical information and the assistance provided by the animal.” Id., at 11.

Ms. Rubin testified that Mira helps her order her life, and reminds her to take medications, eat meals, and when to get up. The Court concluded that because Ms. Rubin did not demonstrate a need for her assistance animal directly related to the disability described by her physician, we cannot conclude that Ms. Rubin satisfied her burden.

It is clear that Mira is important to Ms. Rubin and enhances her quality of life. Ms. Rubin’s physician stated:

[Ms.] Rubin has multiple medical issues that affect her mobility. She benefits from the support of a service dog. She currently has a dog that serves this role for her. Please consider allowing [Ms. Rubin] to keep the dog. Loss of this animal would impair her ability to function.

But the Court Opinion concluded:

because Ms. Rubin’s physician described a disability related to her mobility, and there was no evidence establishing a nexus between her mobility-related needs and the requested assistance animal, Ms. Rubin did not meet her burden of proving that it was necessary for Kennedy House to waive its no-dog policy.

There is increasing evidence (for those who did not believe it empirically) that pet ownership benefits humans physically and emotionally, whether disabled or able-bodied.

As people become more reliant on this bond with their pets, we should expect to see the attempted use of service and assistance animals continue to expand, as previously discussed on several occasions (Colorado Attempts to Crack Down on Fake Service Animals ; Protecting the Rights of Disabled Individuals’ Continued Use of Service Animals ; A Commission to Ensure Integrity in the use of Service Animals ; Service Animal or Playful Pet? Complying with the Americans with Disabilities Act ).