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.

holstein

Dairy farmers, and other food animal producers, should be ever-vigilant in their use of medications to treat their herds and flocks, otherwise they may be at risk of violating certain federal laws.  Following through with its promise to increase its enforcement activities, FDA has already issued more warning letters to dairy farmers, for misuse of medications, in the first two months of 2014, than they had in all of 2013. (See FDA’s website).

A warning letter from the FDA requires an expedited written response-within 15 days-outlining the steps the farmer taken to come into compliance.  Farmers, who fail to respond timely or sufficiently, risk facing the threatened regulatory action of seizure or injunction.

The violations recently cited by the FDA in warning letters to dairy farmers resulted from:

  1. the presence of drugs approved for use in food animals, but identified in tissues at slaughter at levels which exceed those established by FDA; or
  2. the presence of drugs not approved for use in food animals and identified in tissues at slaughter.

The use of drugs in a manner that is not indicated on the label is considered an “extralabel use” and is only permitted under limited circumstances in food animals, and only “by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship.”

If drug residues are identified at slaughter, FDA usually sends investigators to the farm to inspect the farming operation and interview farmers and their employees.  These unannounced on-farm investigations often occur months after the treated animal has been tested, and can result in additional violations cited.

To ensure that farm operations are in compliance with the law, dairy farmers should consult with their veterinarians about the proper use of medications approved for use in cattle, including the appropriate route of administration, dosage, documentation of treatment, separation of treated animals, and withholding times required to ensure that residues in meat and milk products will not exceed permitted levels.

 

Following the lead from New York City, the enforcement of New Jersey’s Animal Cruelty Statute should be placed squarely under the authority of state and local police, with animal control officers, animal cruelty investigators, certified livestock investigators, and SPCA officers providing technical support and expertise, when needed.

As recently reported by the ASPCA, the long-standing voluntary enforcement of the NYC animal cruelty statute by ASPCA officers was relinquished to the NYPD “to do what the ASPCA cannot accomplish alone: incorporate the enforcement of animal cruelty laws into routine, everyday law enforcement work; elevate the importance of preventing crimes against animals; and provide necessary resources to combat those crimes.”

The enforcement of the NJ statute, by state and county SPCA agents who receive only minimal law enforcement training, has been critically reviewed by the State Commission of Investigation and the Animal Welfare Task Force, as previously reported.  As recognized in New York, the enforcement of this statute should be a clear responsibility of law enforcement professionals to help insure the protection of animals while also providing for safety of those responding to potentially dangerous conditions.  Acknowledging the importance of enforcing this statute is consistent with the apparent interest by state legislators to amend the cruelty statute, and by increasing penalties and expanding conduct considered criminally or civilly actionable.

It is time for violations of the animal cruelty statute to be considered a prime responsibility of the state’s professional law enforcement officers.

The new mayor of New York City promised to ban the use of carriage horses in the city, an iconic attraction for city dwellers and visitors from around the globe.  Like my brother who proposed to my sister-in-law on a horse-drawn NYC carriage, these carriages have served as much more than a mere source of transportation.

Despite the fact that the carriage horses are apparently healthy and humanely treated, according to veterinarians who have recently examined them and inspected the stables in which they are housed, their current use has been condemned as inhumane.

If this use is inhumane, then what about other uses of horses, namely:

  • As service animals for law enforcement and crowd control, navigating the same streets of New York that activists claim are unsafe for carriage horses;
  • As carriage horses for the Amish and Mennonites, used to transport their occupants on highways alongside automobiles and trucks; and
  • As athletes in equestrian competitive events, including cart, carriage, and pulling events.

Opponents of the use of carriage horses in NYC claim that these horses are deprived of access to pasture, despite their 5 week/year required relocation to farms for such access.  If lack of pasture access is a measure of inhumane treatment, then the treatment of many show and race horses, similarly restricted,  would also be considered inhumane.  Additionally, many stables in the tri-state area have minimal, if any, land available for pasture.  Many horses living on these premises are extradorinary athletes who receive exemplary care.  Finally, restricting access to pasture is often beneficial to horses, especially when during icy, snowy, or other treacherous conditions.

Any legitimate concerns over the care and use of carriage horses should be addressed by amending the laws governing the standards of their care.  Whether used for work, entertainment, exhibition, racing, or other equestrian purposes, the best remedy is to require standards that ensure that the care of horses is humanely provided.  Bans on specific uses, like the use of carriage horses in NYC, is not the answer.  The partnership between humans and horses, one which has endured throughout history, is worthy of preservation, for the benefit of both species.

A new proposed law in New Jersey, Assemby Bill No. 1717, would make “assault by animal” a crime when a person purposely uses an animal to intimidate or put another person in fear of bodily injury.  Most people would think this is a good law.  However, the bill may unintentionally criminalize the use of guard dogs—used to intimidate would-be intruders.

While there are many people who are opposed to the use of dogs to guard property, it is not at all clear that the intent of this proposed law was to criminalize the use of guard dogs.

On November 25, 2013, the New Jersey Judiciary Committee voted in favor of this bill.  During the committee hearing, nj.com reported that Assemblywoman Holly Schepsi abstained from the vote, because she was concerned that homeowners may be charged with this crime if an owner’s dog attacked an intruder in the home.  That question was not answered.

However, if a homeowner could be liable under those circumstances, then it would appear that the owner of a dog used to guard property could be charged with such a crime, no matter how minor the charges. And if an intruder is injured by a dog used in this way, the charges would escalate.

To be clear, the question here is not about whether the use of dogs to guard property should be illegal. Instead, the first question is whether this proposed bill will, intentionally or not, affect a dog owner’s currently legal right to use dogs in this fashion.

This bill exemplifies the complexity of issues involving animals and the law, and the necessity to carefully review the impact of any bill proposals, for the intended and untended consequences that would result from its adoption.  While the intent of this bill may be laudable—to criminalize the act of attacking another person with the use of an animal, the language should be clarified to protect home owners and property owners.  On the other hand, if the intent includes the elimination of the use of guard dogs, that should be clearly articulated in the bill statement, to ensure that public discussion on the merits of such a proposal occurs before the bill becomes law.

 

 

Dog owners should be aware of a study performed by MGA Research Corporation, a nationally certified testing facility, which tested 11 different dog harnesses for safety and efficacy.  Testing was funded by the Center for Pet Safety, which published the results on its website.

Keeping in mind that there are no approved standards for safety of dogs traveling in cars, MGA analyzed three sizes of each type of harness tested, recognizing that the size of the dog and harness used are different variables that might affect the outcome of a crash.

 

 

 

 

 

 

This study, and many of the harness manufacturers advertising the safety of their products, refer to the Federal Motor Carrier Safety Administration’s safety standards for child restraint systems, Federal Motor Vehicle Safety Standard (FMVSS) 213.  Extrapolating from children to dogs may not be the most accurate method for such testing, but with no other national guidelines available, it provides, at least, for some uniformity.

What pet owners should keep in mind is that not all restraints are safe to use in a car.

  • A leashed dog could choke or suffer neck and back injuries, if kept on a leash while in the car, particularly if the leash is tied to a part of the interior of the car.
  • Pets traveling inside pet carriers that are not properly secured to the vehicle’s interior, could become even more hazardous projectiles, than if they were not traveling inside a carrier.

Size matters: products should be selected for the type and size of animal for which it will be used.  One size fits all will not work the way it is intended to work.

What works for dogs, will often not work for cats, or other pets.

Bottom line: everyone wants their pets and other passengers to be safe inside vehicles.  Since federal guidelines do not yet exist for pet harnesses or other safety measures for traveling pets, it pays to read the research available, whether provided by harness manufacturers or third parties, and make sure your pets are not distractions for the driver.

Safe travels!