The Food Animal Residue Avoidance Databank (FARAD) recently provided guidance to small ruminant producers and their veterinarians in an article titled “Extralabel drug use (ELDU) in small ruminants” in JAVMA, Vol 253, No. 8, Oct. 15, 2018, pp 1001-1009.

FARAD is a university-based national program that serves as the primary source for scientifically-based recommendations regarding safe withdrawal intervals of drugs and chemicals in food-producing animals. As such, FARAD is a key resource for protection of our nation’s food supply, including meat, milk and eggs, against accidental contamination of animal-derived foods with violative residues of drugs, pesticides or other agents that could compromise food safety.”

FARAD regularly provides guidance to the food animal producing industry and veterinarians regarding “the use of therapeutic drugs, pesticides and other agents that improve overall animal health and promote safe, efficient and humane production practices.”

The purpose of its latest digest, as stated, “was to provide US veterinarians guidance regarding ELDU in small ruminants. The lack of FDA-approved drugs for sheep and goats frequently necessitates ELDU in those species. When the FDA approves a drug for use in a particular species, it establishes a tolerance or that drug in the various tissues or products (eg, milk or eggs) of that species that might be consumed by people. When a drug not labeled for use in a small ruminant is administered in an extralabel manner, there is a zero tolerance for residues of the parent drug or its metabolites in the edible tissues or products of treated animals, and detection of the parent drug or metabolites in any product marketed for human consumption is considered a violation and subject to regulatory action. Given the lack of tolerance and pharmacokinetic and tissue depletion data for many drugs administered in an extralabel manner to small ruminants, extended meat and milk WDIs are generally required to ensure that drug residues are undetectable. Veterinarians need to be cognizant of the requirements for legal ELDU in food-animal species to safeguard the human food supply while continuing to promote the health and welfare of small ruminants.”

As a former owner of a veterinary large animal practice in which 50% of my patients were small ruminants (goats, sheep, alpaca and llama), it was imperative to be able to prescribe or administer drugs in an extralabel manner to provide humane care and prevent animal suffering.

Extralabel use means actual use or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling. This includes, but is not limited to, use in species not listed in the labeling, use for indications (disease or other conditions) not listed in the labeling, use at dosage levels, frequencies, or routes of administration other than those stated in the labeling, and deviation from the labeled withdrawal time based on these different uses.  21 CFR 530.3.

Some of these uses have included medications added to commercial feeds, that are now governed under the Veterinary Feed Directive that FDA enforces for use in major, but not minor species.

According to guidance from FDA, “many commercial medical feeds that require a VFD are not approved for use in minor species,” defined by FDA as all species other than cattle, horses, swine, chickens, turkeys, dogs, and cats.  Compliance Policy Guide Sec. 615.115 Extralabel Use of Medicated Feeds for Minor Species.  A veterinarian may consider ELDU of medicated feed in minor species if:

There are no approved treatment options available;

The health of the animals is threatened; and

Failure to treat the animals would result in suffering or death.

The veterinarian must provide a written recommendation that includes the medical rationale for ELDU of medicated feed.

Before a veterinarian can provide such professional guidance, a valid veterinarian-client-patient relationship (VCPR) must exist.  While state laws govern the practice of veterinary medicine, including such relationships, FDA has inserted itself in the equation by identifying which states do not require the elements of a VCPR that FDA considers sufficient for the purposes of enforcing its Veterinary Feed Directive and other federal laws.

These multilayered state and federal laws can be difficult for veterinarians and small ruminant producers to decipher—hence the necessity of FARAD and other agencies to provide more specific guidance.

Assemblyman Daniel R. Benson introduced a bill (A4298) that would amend “animal cruelty offenses and penalties concerning animal abandonment and failure to report injuring certain animals with a motor vehicle; increases civil penalties for certain other animal cruelty offenses.”  Like so many bills in New Jersey related to animal issues, including another misguided, S2820 to be discussed later, A4298 would subject many livestock owners, including horse owners, to liability under the law, even though their animals are properly cared for.  Many of these proposed amendments are not consistent with the requirements in the “Humane Treatment of Domestic Livestock,” (the “Humane Standards”), N.J.A.C. §§2:8-1.1 et seq. which the legislature mandated for “domestic livestock,” defined as “cattle, horses, donkeys, swine, sheep, goats, rabbits, poultry, fowl, and any other domesticated animal deemed by the State Board of Agriculture and the Department of Agriculture, in consultation with the New Jersey Agricultural Experiment Station, to be domestic livestock for such purposes.”  N.J.S.A. 4:22-16.1 (c).

The Humane Standards provide for feeding, watering, keeping, marketing and sale, and care and treatment of livestock, based on animal science and veterinary medicine.  There is a rebuttable presumption that “the raising, keeping, care, treatment, marketing, and sale of domestic livestock in accordance with the standards . . . shall not constitute a violation of any provision of this title involving alleged cruelty to, or inhumane care or treatment of, domestic livestock.”  N.J.S.A. 4:22-16.1 (b)(1).  However, when both the statute and regulations were enacted, the Humane Standards were consistent with the statutory provisions, including the definition and provisions related to “necessary care.”  If the statutory provisions of “necessary care” require care inconsistent with and in excess of those required by the Humane Standards (which would occur if A4298 became law), the rebuttable presumption may not be applicable.

This issue is compounded by three major factors:

  1. Those enforcing animal cruelty statutes often believe (erroneously) that any time an animal is injured or becomes sick, the owner or caretaker is at fault and liable under the animal cruelty statutes;
  2. Those enforcing animal cruelty statutes are often inadequately trained in animal care, particularly care involving livestock;
  3. Animal activist groups, opposed to animal use by humans, increasingly target law makers and enforcers, providing them with biased, non-scientifically sound, misleading and inaccurate information and proposed statutory language intended to ban the breeding, sale, and use of animals.

Concerns about A4298 relate largely to the amendments of the definition of “necessary care” described below:

The bill would amend the definition of “necessary care” to provide for “care sufficient to preserve the health and well-being of an animal . . . including:

(2)          open or adequate access to drinkable water of an appropriate temperature* in sufficient quantity and quality to satisfy the animal’s needs;

(3)          access to adequate protection from the weather, including access to an enclosed non-hazardous structure sufficient to protect the animal from the weather that has adequate bedding to protect against cold and dampness, and adequate protection from extreme or excessive sunlight and from overexposure to the sun, heat and other weather conditions;

(4)          veterinary care deemed necessary by a reasonably prudent person to prevent or relieve injury, neglect or disease, alleviate suffering, and maintain health; and

(5)          reasonable access to a clean and adequate exercise area.

Taken one by one, here are the concerns:

  1. What does “open” access to drinkable water mean?

Livestock, including horses, must be provided “daily access to water in sufficient quantity and quality to satisfy the animal’s physiologic needs as evidenced by the animal’s hydration status.”  N.J.A.C. 2:8-2.3.  However, animals do not require access to water 24/7, if that is what the definition of “open” access to water means.

  1. The requirement to provide water “of an appropriate temperature” is unnecessary and can lead to unfounded charges of animal cruelty.

The Humane Standards already require the provision of water of sufficient quality which “refers to the acceptability of water sources for animal consumption with response to the presence of contaminants, accessibility and quantity.  Acceptable water quality means that the water is provided in ways that minimize contamination by urine, feces and other material but is accessible to the animals.  It may be provided from natural sources or manmade containers and must be sufficient quantities to prevent dehydration.  Signs of dehydration include sunken eyes, increased capillary refill time of the gums, and/or skin that tents when pinched.  Human standards for potability are not required but there should not be contaminants present in amounts that discourage the animals from drinking adequate amounts.”  N.J.A.C. 2:8-1.2.

Adding a requirement related to the temperature of the water is unnecessary, vague and ambiguous.  Prior attempts to check water temperature have placed livestock in harm’s way.  Agents or officers of the NJSPCA used to attend 4-H fairs regularly and, going livestock pen to livestock pen, would dip their hands in water buckets to “test” the temperature.  Not only was this a completely unscientific method to measure the adequacy of hydration of animals, it presented a huge biosecurity risk through the intentional introduction of potential pathogens from bucket to bucket.

  1. The bill would also require “access to an enclosed non-hazardous structure sufficient to protect the animal from the weather that has adequate bedding to protect against cold and dampness,” a provision that is inconsistent with the Humane Standards.

Each species-based section of the Humane Standards includes provisions relating to housing requirements, which expressly does not require housing in a “non-hazardous structure.”  It does require:

(a) The animal’s environment must provide relief from the elements, such as excessive wind, excessive temperature and excessive precipitation, that result in hyperthermia or hypothermia detrimental to the animal’s health.

(b) Relief under (a) above can be accomplished with natural features of the environment including, but not limited to, trees, land windbreaks, overhangs, or other natural weather barriers or constructed shelters.  N.J.A.C. 2:8-2.4.

  1. The bill would also require animal owners to provide veterinary care deemed necessary by a reasonably prudent person to prevent or relieve injury, neglect or disease, alleviate suffering, and maintain health.

Such provisions could expose any animal owner to liability if they failed to prevent diseases for which vaccines or other preventive treatments are available, but were not administered.  This is not consistent with the basic tenors of veterinary medicine, which requires consideration of the needs of each animal, based on their risk exposure.  The American Animal Hospital Association’s Canine Vaccination Guidelines, for example, states:

Not all dogs need every vaccine. Your veterinarian will ask you questions about your dog’s lifestyle, environment, and travel to help tailor the perfect vaccination plan for him. AAHA’s Lifestyle-Based Vaccine Calculator uses factors such as whether your dog visits dog parks, groomers, competes in dog shows, swims in freshwater lakes, or lives on converted farmland to help you and your veterinarian develop your dog’s individualized vaccination plan.

There are “core” and “noncore” vaccines. Vaccinations are designated as either core, meaning they are recommended for every dog, or noncore, which means they are recommended for dogs at risk for contracting a specific disease. However, your veterinarian may reclassify a “noncore” vaccine as “core” depending on your dog’s age, lifestyle, and where you live—for instance, in a region like New England where Lyme disease is prevalent, that vaccine may be considered “core.”

  1. The bill would also require reasonable access to a clean and adequate exercise area.

This is inconsistent with provisions in the Humane Standards that permits housing in caged systems, stabling of horses, etc.

Significant amendments to A4298 and sister bill S2159 are required to allow for the continued existence of animal agriculture and other animal businesses in the State of New Jersey.

 

*Underlined text are proposed amendments.