Federal Laws and Regulations

On Wednesday, November 15, 2017, Las Vegas City Council voted to enact “Bill No. 2017-40 – which repeals a formerly adopted ordinance which prohibits pet shops from selling or disposing of dogs, cats or potbellied pigs other than those obtained from an animal care facility or nonprofit animal rescue organization.”

As both the American Kennel Club (AKC) and Pet Industry Joint Advisory Council (PIJAC) stated in written testimony, the misrepresentations about the puppies sold at pet stores harms puppies, breeders, pet stores and consumers by removing a highly regulated source of healthy puppies for people desiring a lifelong pet with specific behavioral and physical characteristics they prefer for their families.

As PIJAC explained:

Even as we have worked to raise standards of care, PIJAC has battled misconceptions about the quality of pet store animals and the sources of such animals. The unsubstantiated assertion that pet store animals generally come from substandard breeding facilities is commonly used as a smoke screen to obscure the fact that the overwhelming majority of pet owners who choose to purchase from pet stores bring home a happy, healthy pet and remain highly satisfied with their pet store experience.

The reality is that almost all pet store puppies originate from USDA licensed breeders who are regularly inspected and found to comply with appropriate care standards. By contrast, many of the dogs and cats from other sources, including rogue Internet operators, private sales, shelters and rescues, did not come from licensed breeders.

AKC stated:

An important part of ensuring the success of a pet with a new owner is to ensure that it is an appropriate fit with the owner’s lifestyle. Treasured pets may be obtained from a variety of sources, including breeders, pet stores, rescues, and local shelters.

Under the current law, families in Las Vegas have lost an important source for choosing a quality pet that is the best fit for their lifestyle and circumstances.

There is no credible evidence that puppies purchased from pet stores originate from “puppy mills,” large commercial substandard breeding facilities, or that pet store puppies contribute to shelter populations-misrepresentations that form the bases for pet store sourcing bans.

Las Vegas City Council repealed the pet store sourcing ban. Hopefully, other communities will follow suit.

On a related note, Circuit Judge Hamilton dissented from the majority opinion in a constitutional challenge to a pet store ban in Chicago (Park Pet Shop, Inc. v. City of Chicago, 872 F. 3d 495 (7th Cir. 2017) “[o]n two points critical to the federal Commerce Clause claim.”

First, the Supreme Court itself has not yet confined the balancing test under Pike v. Bruce Church, Inc., 397 U.S. 137 (1970), as narrowly as my colleagues suggest. The majority writes that Pike balancing comes into play ‘only when the law discriminates against interstate commerce in practical application.’ Ante at 502 (emphasis in original), citing National Paint & Coatings Ass’n v. City of Chicago, 45 F.3d 1124, 1131 (7th Cir. 1995) . . . . The majority would apply Pike only when the challenged law gives ‘local firms any competitive advantage over those located elsewhere’ . . . The Supreme Court’s more recent discussions of Pike, since we decided National Paint in 1995, are difficult to reconcile with this approach. For example, the Court has explained that federal courts ‘generally leave the courtroom door open to plaintiffs invoking the rule in Pike, that even nondiscriminatory burdens on commerce may be struck down on a showing that those burdens clearly outweigh the benefits of a state or local practice.’

 

Judge Hamilton also found that “the majority errs by applying a stringent version of Iqbal and Twombly to find that plaintiffs have not plausibly alleged sufficiently burdensome effects on interstate commerce.”

 

Judge Hamilton found that the complaint had sufficiently alleged plausible impacts that the pet store sourcing ban would result in the alleged harms, concluding,

I don’t know whether the plaintiffs in this case could ultimately meet the demands of the Pike balancing test. They should be permitted to try, though, particularly now that the ordinance has taken effect and evidence of actual effects should be available. I would reverse the dismissal for failure to state a claim and remand for further proceedings.

 

 

The “PUPPERS” Act, H.R. 3197, a bill that would prohibit the use of canines in biomedical research at the Veterans Administration by eliminating required funding, is misguided and, if enacted, would be harmful to both humans and animals.

Esteemed scientific associations (listed below) wrote to Congressional representatives, in opposition to H.R. 3197, explaining that while scientists embrace efforts to reduce the number of animals needed in research and to replace animals when possible, animal models are still required before drugs or devices are sufficiently proven to be both safe and efficacious for their intended use.  While the number of dogs involved in biomedical research has been reduced, their contribution remains critical in finding cures for certain diseases and disorders, like the previously incurable and fatal genetic disorder affecting skeletal muscles in both humans and dogs, called Myotubular Myopathy (MTM), recently described here.

Canines are currently playing a vital role in the moonshot to end cancer, aging and Alzheimer’s, heart disease, diabetes, and most recently the first FDA-approved artificial pancreas was brought to fruition because of work at the VA. Additionally, 22 of the 25 most prescribed medications were brought to patients’ bedsides thanks to research with canines.

Quote from letter to Congressional representatives from:

  • American Academy of Neurology (AAN);
  • American Association for Laboratory Animal Science (AALAS);
  • American College of Neuropsychopharmacology (ACNP) ;
  • American Neurological Association (ANA);
  • American Society of Laboratory Animal Practitioners (ASLAP);
  • American Society for Pharmacology & Experimental Therapeutics (ASPET);
  • American Thoracic Society (ATS);
  • Americans for Medical Progress (AMP);
  • Associated Medical Schools of New York (AMSNY);
  • Association for Research in Vision and Ophthalmology (ARVO);
  • Association of American Medical Colleges (AAMC);
  • Association of American Universities (AAU);
  • Association of American Veterinary Medical Colleges (AAVMC);
  • Association of Public and Land-grant Universities (APLU);
  • Baylor College of Medicine California Biomedical Research Association (CBRA);
  • Coalition for the Life Sciences The College on Problems of Drug Dependence, Inc. Comparative Biosciences, Inc. Council On Governmental Relations (COGR);
  • Federation of American Societies for Experimental Biology (FASEB);
  • IACUC 101 Series Massachusetts Society for Medical Research (MSMR);
  • Michigan Society for Medical Research (MISMR);
  • National Animal Interest Alliance (NAIA) National Association for Biomedical Research (NABR);
  • National Association of Veterans’ Research & Education Foundations (NAVREF);
  • New Jersey Association for Biomedical Research (NJABR);
  • North Carolina Association for Biomedical Research (NCABR)
  • Northwest Association for Biomedical Research (NWABR);
  • Oregon Health & Science University (OHSU);
  • Pennsylvania Society for Biomedical Research (PSBR);
  • RxGen SNBL USA, Ltd. Society for Neuroscience (SfN);
  • Society for the Study of Reproduction (SSR);
  • States United for Biomedical Research (SUBR);
  • Texas Society for Biomedical Research (TSBR); and
  • University of California, Los Angeles University of Illinois Urbana-Champaign Washington University in St. Louis.

Our ability to study and find cures for many human and animal diseases and disorders would not have been obtainable without studies involving animals, including the following medical achievements:

  • the cardiac pacemaker;
  • the first liver transplant;
  • nicotine patch;
  • the discovery of insulin;
  • vaccinations against canine distemper, parvovirus, rabies, coronavirus, leptospirosis, Lyme disease, measles, and hepatitis;
  • prevention of canine intestinal parasitic diseases, fleas, ticks, mites and mange.

Like the entities listed above I look forward to a time when biomedical research does not involve animal testing, but we currently are not knowledgeable or scientifically advanced enough to entirely replace animals with other models.

Therefore, federally proposed bills, including H.R. 3197 and a similar amendment offered by Rep. Dave Brat (R-VA) to the Defense, Military Construction, Veterans Affairs, Legislative Branch, and Energy and Water Development National Security Appropriations Act, 2018, if adopted, would only serve to harm both human and animal health, and should therefore be opposed.

 

FDA’s recent announcement that it is “withdrawing draft Guidance for Industry (GFI) #230, ‘Compounding Animal Drugs from Bulk Drug Substances’” reminded me that pet owners can become confused about what type of medications are available for treating their pets.  For example, while serving on the New Jersey State Board of Veterinary Medicine, I recall a fair number of consumer complaints that alleged that a veterinarian provided substandard medical care because the medication prescribed to a pet was labeled “for human use only.”  Consumers therefore concluded that the medication harmed their pet.

However, the fact that medication is not specifically approved for use in animals does not mean that it would necessarily be harmful to those animals.

In fact, the use of an approved drug in a manner that is different than stated on the label, has been a fundamental tool used in veterinary medicine since drugs were first labeled.  This “extralabel” drug use was memorialized by Congress in the Animal Medicinal Drug Clarification Act of 1994 (AMDUCA).  See AVMA’s description of AMDUCA.

As AVMA describes on it’s website, “Compounding: FAQ for Veterinarians,” “compounding for animal patients . . . [is] a subpart of  [the] Extralabel Drug Use (ELDU) Rules.”

The ability to use approved drugs in species, for treatments, or at dosages, frequencies, or routes of administration that are not included on the label, is a tool that veterinarians use on a daily basis.  Since obtaining drug approvals for all uses in all types of animal species is cost-prohibitive, the only way some animals can be treated is through the use of drugs in an extra-labeled fashion.

When used properly and pursuant to the standard of care in veterinary medicine, such use should be considered legal.

While FDA has stated that “[c]urrent law does not permit compounding of animal drugs from bulk drug substances,” whether, and to what extent FDA governs compounding in the veterinary space has been the subject of legal debate.

However, FDA’s withdrawal of its guidance document related to compounding animal drugs from bulk substances creates even more confusion and uncertainty for the regulated community.  The now withdrawn guidance document,  Guidance #230, had set forth the situations in which FDA had indicated that it would not take regulatory action against a pharmacy or veterinarian when “an animal drug compounded from bulk substances may be an appropriate treatment option.”

Now, instead of finalizing the draft guidance based on comments received, “FDA intends to publish the new draft in early 2018 for public comment.”

So, the regulated community will be without guidance for a short period of time.

Hopefully FDA’s new guidance will continue to permit compounding from bulk substances when needed to provide adequate medical care for animals in need thereof.

 

As USDA had previously suggested, it just posted a new version of the searchable database that had been dismantled this past February.  Access to the new version is available here.

Many animal rights organizations and animal-trade organizations had expressed outrage or concern when USDA initially dismantled its database.  The current version may not effectuate changes to those positions, since much of the information about individual licensees (compared to licensed businesses) appears to be redacted.

Also, it seems as if license numbers are not available for individuals, but it could be I need to more carefully review the instructions for searching the new database to find that information.

It is a given, that those clamoring for this data will be hard at work deciphering what is and what is not available.

For those pet stores and dealers in towns, cities and states that are required to provide inspection reports to sell puppies, it seems as if the only way to provide such documents from breeders licensed as individuals is to obtain the reports directly from those breeders.

The recent horrific attacks in Syria reminded me of the concerns following 9/11 about potential attacks on livestock and poultry.  Those concerns rose to the highest echelon in our government and others, exemplified by the first International Symposium on Agroterrorism, held in Kansas City, Missouri on May 5, 2005.

I attended that meeting and was awestruck by the opening video-a poignant memorial to the farmers and others involved in agriculture from across the country, highlighting their back-breaking work that feeds and clothes everyone in the United States, and much of the world.  I would love to see that video again-if anyone has a link, please share.

FBI Director Robert S. Mueller, III greeted the attendees, describing the unique challenges involved in distinguishing intentional acts of agroterrorism from natural disease outbreaks:

This distinction is important. If a car bomb explodes outside of a building, we know the attack was intentional. But if a cow contracts Foot and Mouth Disease or a soybean plant exhibits rust, it can be difficult, if not impossible, to determine whether the attack was intentional or occurred naturally.

Director Mueller highlighted the federal, state and local public-private efforts then recently adopted and deployed to investigate a potential threat:

Several months ago, the State Department received an anonymous tip that an unknown individual had threatened to introduce a virus to a large pig farm in Kansas. The State Department passed this information to the Secret Service, which notified one of its agents in Kansas. This agent was part of the FBI’s local Joint Terrorism Task Force. Together, we got the investigative ball rolling.

We coordinated with a local veterinarian, the USDA, and the FDA to assess the threat. Working with INS and local law enforcement, we found this man and questioned him. As it turns out, he had recently returned from South Africa, and it was possible that he could have transported a virus with him.

In the end, this investigation turned out to be a poison pen letter. The man we questioned had no intention of spreading a damaging virus. But because of our established networks, we were able to quickly assess the threat and move to prevent any attack.

In 2008, the FBI, Department of Justice and USDA published the “Criminal Handbook for Agroterrorism,” which “represent[ed] a joint effort of the Federal Bureau of Investigation, Counterterrorism Division; the Food and Drug Administration, Office of Criminal Investigations; the Food and Drug Administration, Center for Food Safety and Applied Nutrition; the Department of Homeland Security; and the U.S. Department of Agriculture, Office of the Inspector General.”

The handbook was considered important since “[a]n attack against the food or agriculture sector . . . requires a high level of cooperation . . .  to identify . . . the threat, prevent . . .the spread of the disease or further contamination of a food product, prevent . . . public panic, and apprehend . . . those responsible. Lack of mutual awareness and understanding, as well as the absence of established communication procedures, could hinder the effectiveness of joint law enforcement investigations. Due to the continued likelihood of attacks against the U.S. food and agriculture sector, the effective use of all resources during an incident will be critical to ensure an efficient and appropriate response.”

Protecting the food supply in this country remains a priority of the FBI, according to Mollie Halpern (not a relative), explaining:

One way the FBI ensures the safety of the nation’s food from farm to fork is through agroterrorism workshops. Our 56 field offices across the country host these workshops, which bring together the public and private sector—such as farmers, law enforcement, federal regulatory agencies, and academia. Supervisory Special Agent Kelly Decker says outreach, liaising, and awareness are the best defenses against agroterrorism.

USDA has continued its efforts to protect the nation’s food supply.  The Office of Inspector General at USDA published a report in March 2017, “Agroterrorism Prevention, Detection, and Response

“to evaluate if USDA’s [Office of Homeland Security and Emergency Coordination’s] OHSEC had developed and communicated effective plans and procedures to prevent, detect, and respond to agroterrorism threats.”

The OIG recommended:

Development and implementation of written processes to effectively oversea USDA’s agroterrorism prevention, detection, and response activities;

Development and implementation of a comprehensive process to track USDA’s compliance with Homeland Security Presidential Directive (HSPD)-9; and

Improvement of the process used to create the Sector Specific Plan (SSP).

The recommendations were largely accepted and will hopefully be completed before they are needed.

 

Japanese macaques, along with 11 other primate species were first listed as threatened on October 19, 1976 by FWS.[1]  However, by special rule, 50 C.F.R. §17.40(c)(2) captive members of these species were exempted from protections under the Endangered Species Act by FWS.  Now, People for the Ethical Treatment of Animals (PETA) has petitioned FWS to correct what they describe as the unlawful deprivation of protection under the ESA.  See Petition to Include the Captive Members of the Species of Primates Enumerated in 50 C.F.R. §17.40(c) as Protected Members of their Respective Species Under the Endangered Species Act.

PETA based its petition, at least in part, on FWS’s relisting captive chimpanzees as endangered species, along with their previously listed wild counterparts.  Endangered and Threatened Wildlife and Plants; Listing All Chimpanzees as Endangered Species, 80 Fed. Reg. 34500 (June 16, 2015).  .  In 2015 The U.S. Fish and Wildlife Service announced a final rule to classify all chimpanzees, both wild and captive, as endangered under the Endangered Species Act (ESA). Until this change, only wild chimpanzees were listed as endangered while captive chimpanzees were listed as threatened.

“We are listing all chimpanzees, whether in the wild or in captivity, as endangered under the Endangered Species Act of 1973, as amended (Act). We have determined that the Act does not allow for captive chimpanzees to be assigned separate legal status from their wild counterparts on the basis of their captive state, including through designation as a separate distinct population segment (DPS). It is also not possible to separate out captive chimpanzees for different legal status under the Act by other approaches. Therefore, we are eliminating the separate classification of chimpanzees held in captivity and listing the entire species, wherever found, as an endangered species under the Act.”

FWS will only issue permits for studies of chimpanzees “only for scientific purposes to benefit wild chimpanzees or to enhance the propagation or survival of chimpanzees, including habitat restoration and research on chimpanzees in the wild that contributes to improved management and recovery.”

If FWS adopts this position for the species currently listed as threatened, more than 316 Japanese macaques involved in research at various biomedical research facilities would be subject to the same fate as many chimpanzees, who unfortunately died when moved to “sanctuaries” since they were not permitted to remain under the care of knowledgeable and trained experts at research facilities.  See Dr. Collins please save our chimps, by Cindy Buckmaster.

Regardless of the outcome of this petition, these animals should remain in facilities where they can be properly cared for, and, if at all possible, the research they have been involved with should be completed so that it is not a loss.

[1] One of the original 12 primates was relisted as endangered in 1990.

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.

 

After a whirlwind of comments and criticisms, USDA has updated its statement regarding the abrupt deactivation of its Animal Care Search Tool, available here https://content.govdelivery.com/accounts/USDAAPHIS/bulletins/185b051.

Similar to statements published on interested parties’ websites, USDA confirmed that this decision was based on internal discussions and review that predated the new administration.

In 2016, well before the change of Administration, APHIS decided to make adjustments to the posting of regulatory records.

USDA noted that the deactivation resulted not only based on guidance from the Department of Justice (see Department of Justice Guide to the Freedom of Information Act and Overview of the Privacy Act), that provides a comprehensive review of litigation related to FOIA and the Privacy Act, but that their action was also related to litigation “APHIS is currently involved in . . . concerning, among other issues, information posted on the agency’s website.”

USDA/APHIS did not identify which litigation it referenced in its updated statement.

Like USDA, many federal agencies struggle to balance transparency with personal and business protections required by federal law.

 Recently, PETA (largely) lost it’s lawsuit against HHS, alleging that the Centers for Disease Control and Prevention had impermissibly withheld information pursuant to PETA’s FOIA request “seeking records submitted by importers of nonhuman primates . . . to CDC pursuant to certain agency regulations.”   People for the Ethical Treatment of Animals v. United States Department of Health and Human Services, No. 15-cv-309, slip op. (D.D.C. January 5, 2017).

In the final Order, the Court granted Defendant’s Corrected Motion for Relief under Fed. R. Civ. P. 60(b) holding:

“The four categories of information the Court previously held qualified for protection pursuant to FOIA Exemption 4 with respect to the records of seven objecting importers—quantity of animals imported, the descriptions of crates used in shipments, the names of the companies that export the animals, and the names of the airline carriers that transport the animals—also qualify for such protection with respect to the records of Central State Primate (‘CSP’), Dallas Zoo Management (‘DZM’), and SBNL USA (‘SNBL’). It is further ORDERED that Plaintiff’s [52] Cross-Motion for Relief under Fed. R. Civ. P. 60(b) is GRANTED-IN-PART and DENIED-IN-PART. Plaintiff’s motion is GRANTED in that information regarding the quantity of animals imported and the descriptions of crates used in shipments on the records of Worldwide Primates, Inc. (‘WWP’) and Primate Products Inc. (‘PPI’) does not qualify for protection pursuant to FOIA Exemption 4. Plaintiff’s motion is DENIED in all other respects.  Id., slip op. (D.D.C. Feb. 6, 2017).”

PETA has appealed this decision.

In a stunning turn of events, USDA has deactivated it’s Animal Care Search Tool, as indicated on its website:

Animal Care Search Tool-DEACTIVATED
Animal Care Search Tool-DEACTIVATED.

USDA inspection reports of licensees pursuant to the Animal Welfare Act, among other data, were previously available on this search engine.

The following alert is provided when clicking on the link (now deactivated):

If the law requiring such disclosure is not specific about where the pet store must obtain the inspection reports, then the pet stores may have to obtain those documents from their sources.  Certainly, they will be unable to obtain the reports quickly through a FOIA request (unless that process has drastically changed).  Even if obtainable through FOIA, it seems likely that the breeder’s personal information, required by many laws, will be redacted by USDA.

It will be incredibly interesting and insightful to hear more about the legal basis USDA relied upon to protect this personal information under the Privacy Act and other laws, as mentioned in the alert.

It seems likely that USDA will be explaining this in court when this policy is undoubtedly challenged.  See some of their thinking at their Q&A on their website.

Without access to USDA inspection reports, animal activists, intent on closing pet stores and eliminating dog breeding, will be unable to misrepresent the meaning of non-compliant citations on those reports, as they have consistently done to convince legislators to ban sales of pets based on mere citations.  Such citations do not mean that licensees have violated the AWA.  As described in USDA’s alert, inspection reports and other legal proceedings that have not received final adjudication are no longer available.  Hopefully, this will help ensure that licensees are provided with due process of the law that the Constitution and justice requires before their businesses are effectively shuttered.

I had the opportunity to present an “Animal Law Update” on October 21, 2016 at the New Jersey Association for Biomedical Research’s 23rd Annual IACUC Conference – the region’s premier training conference for professionals in laboratory animal research field.  Among this year’s 110 participants were key institution decision makers, Animal Care and Use Committee members, lab animal veterinarians, animal welfare compliance specialists and other lab animal research team members from the pharmaceutical industry, contract research organizations, academic research institutions, and government officials from USDA and NIH.

 

During my presentation I discussed the legal issues affecting animal-related industries, including the biomedical research community and analyzed activist activities that can help the research community predict, prepare for, and defend against such challenges.   I was also re-elected to the Board of Directors of the New Jersey Association for Biomedical Research during the annual meeting, held at the beginning of this conference.

 

Dr. William Stokes, Assistant Director, Animal Welfare Operations, USDA, APHIS, Animal Care provided an informative USDA Regulatory Update and Insights.  Dr. Stokes shared USDA Animal Care’s “5-year Strategic Plan” including the mission and vision of the agency, also available on its website:

New to the agency is the introduction of the term “critical noncompliant items” (“NCI’s) which includes all “direct noncompliant items” and certain “indirect noncompliant items.”  Dr. Stokes explained that this term was not really new, and had been used in practical effect, by the agency for a long time.

Dr. Stokes also provided important data from USDA’s inspections authorized by the Animal Welfare Act including:

  • There were over 10,000 unannounced inspections in FY16 of research facilities, breeders, dealers, exhibitors, transporters and intermediate handlers;
  • There were about 1350 inspections of the 1050 registered research facilities;
  • 76% of these inspections had no NCI’s;
  • Of the 561 NCI’s in research facilities, 38% of those were related to activities and conduct of Institutional Animal Care and Use Committees, and specifically related to the semi-annual reports that are required by the AWA.

Dr. Stokes  informed the attendees about the updated public search engine that serves as the database for USDA licensees and related inspection reports, known as the Animal Care Information System (ACIS3).  USDA  sent a bulletin on  09/22/2016 to stakeholders titled “New Terms Will Appear on USDA Inspection Reports.” As Dr. Stokes explained, there are two new terms that will appear on reports and in search results:

  • Focused inspections
  • Critical noncompliant items.

Dr. Stokes ended his presentation reminding all attendees that the goal of USDA and its licensees is to “optimize welfare.”