Laboratory Testing

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Genetic testing in human and animal medicine has been used for some time, and shows great promise, when used judiciously.  For example, genotyping the avian influenza virus and other pathogens has helped animal and human health officials understand the spread of pathogens so that measures can be implemented to prevent or mitigate such spread.

As reported by Greg Cima, “[f]aster, cheaper genome sequencing is helping public health researchers identify the risks of drug resistance and medical treatment failure . . . The sequences also may help federal investigators find outbreak sources, by geographic location and species, as well as guide vaccine and antimicrobial development.”  Finding risks in a flood of genetic data, JAVMAnews Issues, Aug. 1, 2016. .

According to Dr. Jerold Bell, a small animal practitioner and adjunct professor at the Tufts University Cummings School of Veterinary Medicine, “[c]ompanies are using diagnostics to determine what breeds exist in a mixed-breed dog . . . Some companies take it one step further and also tests for genes controlling body conformation and known disease-causing mutations.”  M.S, Filippo, Genetic testing for pets quickly catching up to its human counterpart, AVMA press release, 8/8/2016.

Diagnostic test results are rarely dispositive, and the reliability of the results can be influenced by many factors, including, but not limited to: sample collection; quality control and quality assurance of test reagents; method and proficiency of testing; and interpretation of test results.  Even tests performed by USDA-APHIS-approved laboratories that are part of the National Animal Health Laboratory Network, using reference materials and proficiency tests produced at the National Veterinary Services Laboratory that are accredited to international standards, must be interpreted by knowledgeable clinicians.

As a large animal veterinarian, when I received laboratory results from state or private laboratories that did not seem consistent with my patient’s clinical signs, I would consult with the laboratory director and other officials to discuss those inconsistencies.  Sometimes, additional testing was warranted.  In some cases, the final results were never definitive.

As the Director, Division of Animal Health, New Jersey Department of Agriculture I was responsible for the oversight of the only animal health diagnostic laboratory in the State, and for interpreting laboratory results related to regulated and reportable diseases.  That analysis started with the laboratory test results, and where the results appeared inconsistent with the clinical signs of the tested animal, an in depth review of the testing process from sample collection to results ensued.

Based on this extensive background and understanding of testing, I am concerned about the inappropriate use of certain genetic tests to refute the pedigree registration status of purebred dogs.  As several courts have held, genetic testing is currently not dispositive of pedigree registration status.  See, e.g., Sandra Shines v. Furry Babies Stratford Square, Inc., No. 13-3592, slip op. at 9 (Ill. 18th Jud. Cir. Jan. 22, 2014) (finding DNA test results unreliable to support plaintiff’s claim that the cocker spaniel in dispute was a mixed breed).

Mars Veterinary, a business unit of Mars Petcare that sells a DNA genetic test called Wisdom Panel® warns that the test is not “intended to be used in any judicial proceedings” and further suggests that “[i]f questions arise as to a purebred dog’s pedigree and breed ancestry, parentage testing through the AKC is the appropriate course of action. For this evaluation, the documented sire and/or dam are examined to ensure they were the genetic contributors to the dog in question. If they are confirmed as the parents, their pedigree (and breed) is conferred onto the puppy.”  See Wisdom Panel® Terms and Conditions.

The purebred status of dogs is based on documentation confirming each dog’s lineage, required by the relevant breed canine breed registries—not the results of DNA testing.  Similarly, ancestry DNA testing in humans could not be used to nullify the citizen status of a third-generation U.S. citizen, no matter what their genetic makeup reveals.

The proper use of genetic testing is reflected in AVMA’s new policy on “Inherited Disorders in Responsible Breeding of Companion Animals” which “supports research in genetic and inherited disorders to better educate the profession and breeders on identifying and minimizing inherited disorders in companion animal breeding programs.”  K. Burns, AVMA passes policy on responsible pet breeding, JAVMAnews, Feb. 15, 2017.

Undoubtedly, genetic testing will be used as a increasingly important tool for pathogen tracking, disease control purposes, to help guide responsible dog breeders and to help identify the genetic make-up of mixed breed dogs, with unknown pedigree.

 

 Guest Blog-republished with permission.First published by AMP News Service Wednesday, November 18, 2015
In a late afternoon conference call with scientific society and research advocacy leaders, a National Institutes of Health official confirmed media reports that the NIH is planning to retire the 50 NIH-owned chimpanzees that currently remain available for research, and  send them to sanctuaries.  The NIH will also phase out its funding for the remaining research chimpanzees that it supports, but does not own. A formal statement by NIH is expected later today, but as of this writing had not yet been posted to the NIH site. In 2013, following recommendations by an internal advisory panel, NIH retired over 300 chimpanzees, maintaining a reserve of 50 animals that could be called upon in case of a critical research need.  At that time, NIH indicated that it would revisit the situation every few years.  After a review of the research landscape this summer, NIH Director Francis Collins made the decision to retire the remaining chimpanzees.  Where will the animals go when few sanctuaries can adequately care for research chimpanzees and those that can are reaching capacity?  The first transfer of animals will reportedly be of 20 NIH-owned chimpanzees from the Southwest National Primate Research Center in Texas to Chimp Haven in Louisiana. That transfer will take up all but five of Chimp Haven’s currently available spaces. NIH then plans to move 139 chimpanzees from the Michale E. Keeling Center for Comparative Medicine and Research, part of the University of Texas MD Anderson Cancer Center.  Chris Abee, director of the center, told Nature that this would essentially end chimpanzee research there.  “If these chimpanzees are moved to Chimp Haven, these facilities will be empty while Chimp Haven will have to build more facilities.  This decision demonstrates a fundamental lack of understanding of the quality of care and the quality of life provided chimpanzees at the Keeling Center,” he told Nature. Nature also quotes Frankie Trull of FBR who questioned the logic of NIH’s decision, and Allyson Bennett, a scientist at the University of Wisconsin – Madison.  Bennett raises questions about the wisdom of moving the animals to sanctuaries which are not subject to the standards and oversight of NIH-supported facilities.  Peter Walsh, a disease ecologist at the University of Cambridge, told Nature that his work to produce an Ebola vaccine for wild chimpanzees has been jeopardized. The NIH official on this afternoon’s conference call was careful to state that the decision absolutely did not set a precedent, and that there was a continued need for research with other nonhuman primates and other animals. 

Nevertheless, animal rights activists are making it clear that NIH’s decision will not stop protests against research with other animals. PETA’s Justin Goodman said “we are relieved and happy that NIH is fulfilling its promise to finally end this dark legacy. We will continue to encourage the same considerations for all primates in laboratories.” In a media statement this afternoon, Wayne Pacelle of the HSUS stated, “It’s rare to close out a category of animal use so emphatically.  That’s exactly what’s happening here, and it’s thrilling!” PCRM’s John Pippin also took a victory lap in a press release this afternoon. The coming days and weeks will certainly see this story picked up by media worldwide, with animal rights groups such as PETA, PCRM and HSUS asserting that they influenced NIH in making its decision, and using the decision to mount new fundraising campaigns to support further pressure on NIH and animal-based research in general.

The New York Times published an article[1] on the use of a growth promotant (ractopamine) used by some cattle and hog producers to increase the efficiency of the final stages of growth before animals are slaughtered. I recently described the shift away from the use of antibiotics in the livestock industry.

USDA recently approved food manufacturers in the U.S. to indicate that no ractopamine was fed to the livestock producing the meat so labeled. Not that many consumers will know what ractopamine is, but as previously discussed, consumers are increasingly choosing food from animal raised with more “natural” and untreated feed. “Ractopamine” is not a term or ingredient one thinks of as “natural.”

Two things came to mind when reading this article (that prompted this blog).

First, as the NYT article pointed out, food manufacturers and livestock producers have been eliminating the use of certain feed ingredients, including ractopamine, to avoid embargoes from other countries that ban the importation of such products. The influence of international markets on of livestock production in this country is expanding exponentially and will have an even greater impact in the future. Stay tuned for more on this topic.

Second, it occurred to me that many reading the article may not know that USDA, not FDA is responsible for food labeling of certain meat products, but there are at least three federal agencies with some authority over how livestock are raised (USDA, FDA, and EPA)[2].

The Food Safety and Inspection Service (FSIS) is the public health agency in the U.S. Department of Agriculture responsible for ensuring that the nation’s commercial supply of meat, poultry, and egg products is safe, wholesome, and correctly labeled and packaged.

FSIS has a “glossary of meat and poultry labeling terms” on its website. Here are some defined terms:

According to FSIS “Natural” means:[1]

[1] FDA, another federal agency with authority over livestock feed and drugs, does not have a definition for “natural.”

A product containing no artificial ingredient or added color and is only minimally processed. Minimal processing means that the product was processed in a manner that does not fundamentally alter the product. The label must include a statement explaining the meaning of the term.

FSIS does not permit a label to state “No Hormones (pork or poultry)” because “hormones are not allowed in raising hogs or poultry.”

Therefore, the claim ‘no hormones added’ cannot be used on the labels of pork or poultry unless it is followed by a statement that says ‘Federal regulations prohibit the use of hormones.’

In addition to labeling requirements, FSIS also establishes and approves the laboratory methods used to test for the presence of ractopamine in bovine and swine muscle and liver.

But FSIS does not have the authority to establish which tolerance levels are permitted in these products or in the environment. FDA establishes the tolerance levels permitted in meats sold in interstate commerce, and EPA establishes permissible environmental tolerance values. For more on FDA’s authority go to “FDA’s authority over livestock production and food labeling.”

For decades pundits have discussed moving all food production and related commerce under the authority of one agency.

Maybe the next administration will consider this consolidated approach . . . Or maybe not.

[1] Stephanie Storm, New Label Identifies Pork Without a Growth Drug,” New York Times (September 5, 2015)

[2] U.S. Department of Health & Human Services lists FSIS, FDA, and CDC as three main federal agencies with authority over food safety at Selected Federal Agencies with a Role in Food Safety.

I previously described the potential pitfalls for those using DNA tests to identify dogs leaving behind specimens (aka poop) in public areas.

As expected, more communities are using the “poop detector tests” to penalize residents who do not pick up after their dogs.  As described recently in the New York Times, a condominium in Brooklyn Heights is using mandatory DNA testing of resident dogs to fine those who fail to clean up after their canine companions.

The objections and concerns described in the article included residents fearful that their neighbors would frame them with “fecal evidence” or those who believed this type of scrutiny could evolve into breed ownership limitations.

A number of laboratories are now offering DNA testing, including for example:

  1. Veterinary Genetics Laboratory at the University of California, Davis (DogPile ID Database)
  2. PooPrints

The University of California describes why its testing is reliable:

Although feces is not an ideal source for DNA profiling, the Forensic Unit of the VGL has developed new tests that can overcome problems commonly encountered with feces testing to make sure that your results are accurate, reproducible, and can hold up in court. The DogPile ID test is the only dog DNA testing offered by an accredited crime laboratory that has been accepted by a court of law.

PooPrints describes the science behind its testing.

Our instruments (electronic pipettes, balances, reagent cold storage, etc.) must pass maintenance, yearly calibration, and certification from a third party provider. Considered the industry gold standard in medium to high throughput in genetic analysis, our ABI 3730 DNA Analyzer is also certified yearly by an ABI service engineer. Our technicians must complete training and evaluation in each category before moving on to analyze our customer samples. These standards allow BioPet Vet Lab to offer precise and reproducible DNA fragment analysis.

It also explains why its DNA tests are more reliable than DNA tests used to determine breed, which are known to be somewhat unreliable.

Canine breed identification lends itself to slight variations, because results are based on statistical clustering comparison with a specific database of genotypes of purebreds. This clustering analysis produces statistics based on the database it is compared against. Meaning the actual breed percentages are only as strong as the database it is compared against; too few breeds in the database and you could be less likely to capture all breeds present in a mix-breed sample. Too many breeds in the database, and you run the risk of oversaturating and resulting too many breeds all with lower percentages. So, while the method of extracting and producing the genotype may be very precise, the clustering analysis with a purebred database is the variant in resulting. In contrast to breed identification, PooPrints creates a profile specific to the individual dog, and we do not determine any information concerning the breed makeup.

PooPrints also explains how it can differentiate contaminated samples.

It is clear that DNA testing is a growing industry.  With increased interest and use, there will likely be additional opportunities for these laboratories to certify the validity of their techniques.

However, the mishandling of a sample when obtained and through shipment remains a concern, and could provide a defense for an owner accused of not scooping the poop.

Concerns about raw pet food, previously discussed, have resurfaced with the laboratory isolation of listeria in pet food subsequently recalled by J.J. Fuds, Inc., out of an abundance of caution, as reported on FDA’s website.

Notably, J.J. Fuds, Inc. received no complaints about the health of animals or people resulting from exposure to the pet food, and announced that “the recall was a result of a routine sampling program by the Michigan Department of Agriculture and Rural Development resulting in a positive test for Listeria monocytogenes.”

According to the Center for Food Security & Public Health, “listeriosis is most common in ruminants (sheep, goats and cattle) but occasional cases have occurred in rabbits, guinea pigs, dogs, cats, pigs, poultry, canaries, parrots and other species.”  As a large animal veterinarian, I diagnosed and treated many sheep, goats, and llama infected with this bacteria, which, in these species, causes rapid-onset encephalitis which is often fatal.

The FDA has concerns about feeding raw pet food: “compared to other types of pet food, raw pet food is more likely to be contaminated with disease-causing bacteria, such as Salmonella and Listeria monocytogenes.”

Published guidelines on FDA’s website to prevent infection if handling raw pet food include:

  • Thoroughly wash your hands with soap and water (for at least 20 seconds) after handling raw pet food, and after touching surfaces or objects that have come in contact with the raw food.
  • Thoroughly clean and disinfect all surfaces and objects that come in contact with raw pet food. First wash with hot soapy water and then follow with a disinfectant. You can also run items through the dishwasher after each use to clean and disinfect them.
  • Freeze raw meat and poultry products until you are ready to use them, and thaw them in your refrigerator or microwave, not on your countertop or in your sink.
  • Carefully handle raw and frozen meat and poultry products. Don’t rinse raw meat, poultry, fish, and seafood. Bacteria in the raw juices can splash and spread to other food and surfaces.
  • Keep raw food separate from other food.
  • Immediately cover and refrigerate what your pet doesn’t eat, or throw the leftovers out safely.
  • If you’re using raw ingredients to make your own cooked pet food, be sure to cook all food to a proper internal temperature as measured by a food thermometer. Thorough cooking kills Salmonella, L. monocytogenes, and other harmful foodborne bacteria.
  • Don’t kiss your pet around its mouth, and don’t let your pet lick your face. This is especially important after your pet has just finished eating raw food.
  • Thoroughly wash your hands after touching or being licked by your pet. If your pet gives you a “kiss,” be sure to also wash your face.

CDC tracks food borne outbreaks and has identified seven investigations involving listeria from 2006-2014:

•Commercially Produced, Prepackaged Caramel Apples (2014) – Listeria monocytogenes

•Wholesome Soy Products Sprouts (2014) – Listeria monocytogenes

•Oasis Brands Cheese (2014)– Listeria monocytogenes

•Roos Foods Dairy Products (2014)– Listeria monocytogenes

•Crave Brothers Farmstead Cheeses (2013)– Listeria monocytogenes

•Frescolina Marte Brand Ricotta Salata Cheese (2012)–Listeria monocytogenes

•Jensen Farms Cantaloupes (2011)- Listeria monocytogenes

Justin Goodman, PETA’s director of laboratory investigations as David Grimm recently described in the article titled “The Insurgent” published in Science, Vol. 347, Issue 6220, January 23, 2015 “attempt[s] to show researchers that animal experimentation is flawed, cruel, and just plain worthless.”

Goodman owns a dog and two cats, according to Grimm.  Hopefully, those pets are vaccinated against common and preventable diseases, are tested for parasites, treated if appropriate, and are also provided medications when needed.

Those vaccines or medications are only approved by USDA or FDA, respectively, after they are sufficiently proven to be safe and efficacious.  Animal testing is an integral part of the approval process.

www.nature.com/…/v2/n1/images/nrd990-f1.gif

The history of the adoption of and amendments to the Federal Food and Drug law provides an explanation for the increasing testing and safety measures the law requires for drug approvals.

The initial passage of the Pure Food & Drugs Act of 1906 followed widespread public reaction to the publication of Upton Sinclair’s “The Jungle,” describing the unsanitary practices of the meatpacking industry in the U.S.

“The 1937 Elixir Sulfanilamide Incident” preceded the  “enactment in 1938 of the Federal Food, Drug, and Cosmetic Act, the statute that today remains the basis for FDA regulation of these products.”  The Elixir resulted in “the deaths of more than 100 people after using a drug that was clearly unsafe.”

In 1962, following the birth of thousands of babies with congenital defects resulting from fetal exposure to thalidomide in utero, the law was amended to require the premarket establishment of safety and efficacy.

The expansion of premarket approvals for medical devices in 1976 followed pacemaker failures which were reported during 1972 and 1973, and thousands of injuries reportedly caused by the Dalkon Shield intrauterine device in 1975.

In 2007, the FDA obtained additional authority to perform post market surveillance and request additional data from drug companies.

In addition to protecting human health, the law has continued to evolve to benefit animals and their health, as described on FDA’s website:

While breeders and genetic engineers are focusing on animals as sources of food, other veterinary researchers continue to develop products to improve the health of pets. In 2004, the CVM approved Vetsulin, the first FDA-approved veterinary insulin for the treatment of dogs with diabetes mellitis. “We expect progress in disease and drug research to generate new drugs for our companion animals,” says Sundlof. “We’re seeing the same type of research to develop drugs for pets as for humans, such as treatments to improve the quality of life for older dogs and cats.”

While researchers are exploring and implementing alternatives to animal testing, this remains a critical phase to prove a drug’s safety and efficacy.

So while Goodman may not think animal testing is necessary, it remains a requirement for animal and human drug and vaccine approval.

As to Goodman’s tattoos which, according to Grimm cover “most of his skin,” they too have been tested on animals.

While FDA admittedly “has not traditionally regulated tattoo inks or the pigments used in them,” laboratories, including FDA’s Arkansas-based National Center for Toxicological Research (NCTR), are researching how the body metabolizes tattoo ink, as well as their short and long term effects, using animals when needed to investigate the potential toxic effects of tattoo ink in humans.

There are a lot of myths circulated by animal rights activists about the use of animals in biomedical research, which they are opposed to, even when such research benefits the animals themselves.

Most scientists and researchers understand that biomedical progress usually requires studies in animals to prove that vaccines, medications, and medical devices are safe and efficacious before they will be approved by FDA or USDA (USDA approves vaccines used to protect animal health).

FDA’s Guidance for Industry and Reviewers for Exploratory Investigational New Drug (IND) Studies explains why animal testing is required:

“Before the human studies can begin, an IND must be submitted to the Agency containing, among other things, information on any risks anticipated based on the results of pharmacologic and toxicological data collected during studies of the drug in animals (21 CFR 312.23(a)(8)). These basic safety tests are most often performed in rats and dogs. The studies are designed to permit the selection of a safe starting dose for humans, to gain an understanding of which organs may be the targets of toxicity, to estimate the margin of safety between a clinical and a toxic dose, and to predict pharmacokinetic and pharmacodynamic parameters.”

The Center for Veterinary Medicine at FDA provides guidance for new animal drug approval:

“New animal drugs are approved for specific intended uses (indications). To get a drug approved for a new indication, a sponsor submits a new animal drug application (NADA).”

The following information that must be submitted to support an NADA, usually requires animal testing.

  • Effectiveness
  • Chemistry, manufacturing, and controls
  • Safety to the target species
  • Environmental Assessment
  • Human food safety
  • Freedom of Information (FOI) Summary (food-producing animal species), and
  • Labeling

“The target animal safety section may include studies which identify the toxic syndrome(s) associated with the drug and the margin of safety of use of the product in the treated animal. The human food safety section may include short and long term toxicology studies, total residue and metabolism studies, analytical method validation studies, and tissue residue depletion studies.”

The American Association for Laboratory Animal Science (AALAS), an association of professionals that advances responsible laboratory animal care and use to benefit people and animals, describes the regulatory oversight of laboratory facilities:

“Laboratory facilities containing animals must meet strict federal, state and local requirements. Federal regulators routinely inspect laboratories to ensure that animals are adequately housed and cared for. Additionally, many laboratories submit to additional voluntary inspection for accreditation through the Association for the Assessment and Accreditation of Laboratory Animal Care, International (AAALAC).”

“Further, each institution must establish an animal care and use committee [an Institutional Animal Care and Use Committee (IACUC)] that includes an outside member of the public and a veterinarian. This committee oversees, inspects and monitors every potential study to ensure optimal animal care.”

The Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC), a private, nonprofit organization, promotes the humane treatment of animals in science through voluntary accreditation and assessment programs.

“More than 900 companies, universities, hospitals, government agencies and other research institutions in 39 countries have earned AAALAC accreditation, demonstrating their commitment to responsible animal care and use. These institutions volunteer to participate in AAALAC’s program, in addition to complying with the local, state and federal laws that regulate animal research.”

The IACUC, veterinarians, laboratory technicians, and researchers insure that the highest quality of animal care and treatment is provided to the animals they work with to provide the vital information required for the development and approval of life-saving drugs, vaccines, and medical devices.

As AALAS explains, the scientific community advocates highest quality of animal care the for two key reasons.

“First, working with animals in research is a privilege, and those animals helping us unlock the mysteries of disease deserve our respect and compassion. Second, only healthy animals are reliable models for the study of disease.”

Biomedical research remains vitally important to continue the amazing advancements in human and veterinary medicine that have saved hundreds of thousands of lives. The scientists and researchers on the front lines, and the animals they work with, should be respected and honored for their work.

 

Equine Infectious Anemia (“EIA”), a long-dreaded, infectious disease of horses, spread mostly by horse flies and deer flies (the “insect vectors”) made headlines again, when a man reportedly admitted to providing fraudulent EIA (“Coggins”) test records when selling his horse in Louisiana, as reported by Pat Raia, in the Horse.  Louisiana is one of several states where horses infected with this often fatal disease have often been identified, based on annual reports provided by USDA.

EIA, first identified in the U.S. in the late 1800’s, causes acute and chronic disease in horses, and can be prevented by decreasing or eliminating exposure to infected horses through vigorous testing; pest control to minimize exposure of potentially infected vectors; and following protocols to avoid the spread of the virus from contaminated needles and instruments used between horses for routine husbandry procedures.  No vaccines or specific treatment are available to treat infected animals.  Once diagnosed with the disease, horses are either euthanized or placed in strict quarantine for the remainder of their lives.  USDA’s factsheet on EIA provides more detailed information on this important equine disease.

Effective control over the transmission of this disease has been accomplished through a combination of federal and state regulations.  USDA’s Equine Infectious Anemia: Uniform Methods and Rules, dated January 10, 2007, provides:

  • Procedures and criterion for testing;
  • Procedures for handling infected or exposed horses; and
  • Other control procedures.

Many states, including New Jersey, have additional requirements governing the frequency of Coggins testing, often requiring negative tests prior to or upon importation into the state or a change in ownership of the horse.

Since 2011 there has been a decrease in EIA test-positive horses, as monitored and reported by USDA.

  1. In 2011 82 horses tested positive of the 1,681,570 tests performed on horses in the U.S.;
  2. In 2012 36 positive horses were identified from the 1,443,959 tests performed in the U.S.;
  3. In 2013 38 positive horses were identified from the 1,373,008 horses tested in the US.

With the downward trend in positive cases reported annually by USDA, there has also been a tendency by the states to decrease their testing requirements.  However, while the prevalence of the disease has certainly decreased, it has not been eradicated.  Furthermore, the illegal conduct of those few who may falsify test documents, increases the potential exposure of many uninfected horses.

If found guilty of falsifying Coggins reports, in addition to state penalties, the federal government provides for significant fines and imprisonment.

As indicated on the Coggins form:

“Falsification of this form or knowingly using a falsified form is a criminal offense and may result in a fine of not more than $10,000 or imprisonment for not more than 5 years or both (U.S.C. Section 1001).”

If purchasing a horse, you should review all the information on the Coggins test form carefully, before finalizing the purchase.  If only provided by the seller, consider contacting the veterinarian who completed the form, to confirm the accuracy of the information provided.  While veterinary records are generally considered confidential, the seller should willingly permit such disclosures if they have nothing to hide.

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.

 

Legislators plan to re-introduce Moose’s Law in New Jersey’s new legislative session, despite Governor Christie’s pocket veto of the bill.  The law would prohibit anyone from working with animals in New Jersey, unless the Department of Health (“DOH”) certifies that each employee (volunteer or paid) never violated any part of New Jersey’s animal cruelty statute, or committed any similar violations in other states.  The logistics and cost of these investigations have never been addressed, and it is not clear if the information required for review is readily available, can be obtained within the time frame proscribed in the bill, or will actually protect animals from abuse.  However, anyone who is not certified is barred from employment which involves contact with animals in New Jersey.

Additionally, the employment bar is permanent, and mandatory, upon a finding of criminal or civil liability of any provision of the animal cruelty statute.  The type of businesses that will be affected by these new employment restrictions include:

  • Pet stores
  • Animal Shelters and Rescues
  • Farms with animals-dairy, beef, chickens, ducks, swine, fish, llama, etc.
  • Horse barns, stables, racing facilities, including those run by the State of New Jersey
  • Veterinary hospitals
  • Animal breeders, kennels, doggie day care facilities
  • Slaughterhouses
  • Livestock haulers
  • Live bird markets
  • Auctions
  • Zoos and aquaria
  • State and federal officials who work with animals
  • Research facilities
  • Schools with animals in the classroom
  • Animal trainers and groomers
  • Farriers

Everyone currently working at these facilities would have to be cleared by the Department of Health before they are permitted to retain their employment.  Any new employees cannot work directly with animals, unsupervised, until the DOH provides the certification.

In addition to concerns about this bill that were previously addressed, some of the outstanding legal issues and unintended consequences of this bill include:

  • Due process concerns for individuals who previously pled guilty to animal cruelty charges, or agreed to pay a civil penalty instead of pursuing legal defenses.  Barring these individuals from employment in any animal-related enterprise, after the fact, is not only unfair, but violates their constitutional rights.

 

  • Criminal violators may be able to expunge their records, and, once expunged, the bar to employment with animals could be reversed.  Compare that with an individual who violated a similar provision of the statute, but was only found civilly liable.  That individual would not have the ability to expunge their record.  Not only is that result nonsensical, defendants may be inclined to reject the ability to plea to a lesser civil charge, because of this permanent punishment.  Criminal charges require proof beyond a reasonable doubt, instead of merely a preponderance of the evidence.  Therefore, these cases would consume considerably greater prosecutorial and judicial resources than they currently require.

 

  • Veterinarians, licensed by the State Board of Veterinary Medical Examiners, could have their license revoked without any review by the licensing board, and their professional career permanently terminated.

 

  • Other business owners could face similar draconian results, with no recourse seemingly available, once found criminally or civilly liable.  Recent amendments to the cruelty statute added negligence as a statutory violation.  Therefore, even unintentional acts could result in a permanent bar to one’s chosen field of work.

The mandatory bar to employment in the re-introduced bill should be amended to permit a judge to consider whether such a bar is reasonable, on a temporary or permanent basis, based on the facts of each case.

To be clear, there are situations where a violator should be banned from working with animals, for a proscribed or permanent period of time. However, that determination should be left to the trier of fact.

It is unfortunate that the suffering endured by Moose is not better memorialized by a law that could actually prevent the cruelty he was exposed to.  As written, Moose’s Law is unenforceable, unreasonable, and almost certainly doomed to fail.