Clinical trials are commonly used during the development of drugs studied for approval by FDA for the use in animals.  Similar use in veterinary medicine has been increasing, but there are a number of interesting issues not considered in human clinical trials, where the individual involved in such trials is able to provide consent for inclusion in the trial.  Clearly, the animals that may be subject to such studies, cannot provide specific consent—their owner would have to do so on their behalf.  Those advocating for a change in status of animals as “property” to “persons” would be expected to object to such clinical trials, even if they benefit animals and people and help save their lives.

This issue was critically analyzed by veterinarians analyzing whether clinical veterinary studies must be reviewed by institutional animal care and use committees pursuant the Animal Welfare Act; the Office of Laboratory Animal Welfare for those studies funded by NIH; and/or reviewed and approved by a Veterinary Clinical Studies Committee established by a research entity, in a JAVMA published study, “Institutional animal care and use committee review of clinical studies.”

The study found

Determining whether activities conducted under the auspices of a clinical study are regulated by the USDA or OLAW, and thus require IACUC oversight, is not always a clear and simple issue. Institutions should develop their own guidance on how the IACUC oversees-or does not oversee-clinical trials.

Whether and to the extent certain clinical trials required review and approval by the IACUC pursuant to the Animal Welfare Act and/or OLAW requirements was dependent on whether the studying entities purchased the animals involved in the clinical trial and whether the proposed procedures would be required for the animal’s care, or were additional procedures only required for the purposes of the clinical trial.

The article presents 6 examples to help determine when USDA or OLAW oversight would be required.

Clearly, clinical trials, as utilized in human medicine, provide critical data related to the final approval of drugs and medical devices that will help prevent, diagnose and/or treat animals affected with life-altering diseases and conditions.

 

The impact of USDA’s newly adopted final rule to certain exhibitors of farm animals remains unclear.

A positive result of the rule is the definition of “domesticated farm-type animals.”  Farm-type animals are defined as “animals that have historically been kept and raised on farms in the United States.”  Except for the use of the term “domesticated” this definition should be adopted by states to insure that livestock and poultry remain regulated by state and local laws even if owned as “pets” or for “companionship.”

However, the term “domesticated” should be replaced by “domestic,” since courts have held that certain dangerous and exotic animals can be “domesticated” based on the case-specific facts.  See City of Rolling Meadows v. Kyle, 494 N.E.2d 766 (Ill. App. Ct. 1986) (reversing holding that owners monkey was not a domesticated house pet); Turudic v. Stephens, 31 P.3d 465, 471 (Or. Ct. App. 2001) (concluding that “although the cougar may be more exotic than goldfish or hamsters, they are, nevertheless, indisputably family pets.”).  Unfortunately the term “domesticated” instead of “domestic” is used in existing and the amended rule.

Certain exhibitors of ‘domesticated farm-type animals’ are exempt from licensure, including: (1) those who “have a de minimis size of business based on the number of animals maintained, capability of providing adequate care and treatment of such animals, and public oversight . . .”; (2) “country fairs, livestock shows, rodeos, field trials, coursing events . . . and any other fairs or exhibitions intended to advance agricultural arts and sciences, as may be determined by the Secretary”; and (3) owners of “livestock or poultry used or intended for use as food or fiber, or livestock or poultry used or intended for use for improving animal nutrition, breeding, management, or production efficiency, or for improving the quality of food or fiber.”

The amendments exclude from licensure “[a]ny person who maintains a total of eight or fewer pet animals as defined in part 1 of this subchapter, small exotic or wild mammals (such as hedgehogs, degus, spiny mice, prairie dogs, flying squirrels, jerboas, domesticated ferrets, chinchillas, and gerbils), and/or domesticated farm-type animals (such as cows, goats, pigs, sheep, llamas, and alpacas) for exhibition, and is not otherwise required to obtain a license.”

For those who maintain more than eight domesticated farm-type animals, they can also be exempt from licensure if: the animals are used or intended for use as food or fiber; for improving animal nutrition, breeding, management, or production efficiency; or for improving the quality of food or fiber,  even if those animals are exhibited.  However, that was not the holding in In re: Daniel J. Hill and Montrose Orchards, Inc., AWA Docket No. 06-0006, Chief ALJ Hillson (USDA April 18, 2007).

In this case, a Complaint was issued on January 13, 2006, by Kevin Shea, Administrator of the Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture to “Respondents, Daniel J. Hill and Montrose Orchard, Inc., for operating as exhibitors under the Animal Welfare Act without obtaining the requisite license.”

The Findings of Fact, included, in relevant part:

Respondents operate a business which offers the public an opportunity to purchase apples, blueberries, Christmas trees, asparagus, pumpkins and other products. Most products are sold in the Orchard’s gift shop, and some products are also offered to the public on a self-pick basis.

Respondents display to the public a number of animals including, at various times, a pig, a cow, English fallow deer, Barbados sheep and goats. These animals were displayed in large pens. There were signs directing the public to these pens.  There were signs on some of the pens identifying the animal(s) inside.  There were food dispensing machines where members of the public could insert some money and buy food to feed the animals, and a hand washing station near the pens available for public use.

The Court rejected Respondents’ argument that it was exempt from licensure because it made less than $500 from its animal operations.  It also rejected the argument that Respondents were exempt from licensure because “the animals on display at Montrose Orchards were ultimately raised for food.”

Instead the Court held,

Respondents did operate as an exhibitor under the Animal Welfare Act.  I find that Respondents’ operations were in interstate commerce or at least affected commerce, and that the display of animals as part of an inducement to visit a commercial operation constituted the charging of compensation.  I find that the exemption for those who make less than $500 from animal operations applies to dealers, and is inapplicable to Respondents.  I find that while the animals on display at Montrose Orchards were ultimately raised for food, the fact that they were on display for extended periods of time still requires an exhibitor’s license. Finally, I impose a civil penalty of $1,000 against Respondents jointly.

Whether and to the extent that similar “exhibitors” would be considered exempt pursuant to the newly adopted rules, remains to be seen.

Perhaps further clarity from USDA-APHIS would be instructive.

 

On June 4, the regulation titled “Thresholds for De Minimis Activity and Exemptions From Licensing Under the Animal Welfare Act” which purportedly implement[s] amendments to the Animal Welfare Act (AWA), was published by USDA-APHIS, effective on the date of publication.

The regulation expands some exemptions to the licensing requirements pursuant to the AWA.  There are some unintended consequences to these expansions that may be detrimental to certain animal owners.  For example, the ever-expanding pet store sourcing bans often limit sources to USDA-licensed dog breeders—if these professional breeders are not entirely excluded.  Many exempt breeders—those who own four or fewer breeding females—would prefer to be licensed so that they can sell to pet stores.  However, because the provision that permits an exempt breeder to apply for a voluntary license was previously deleted from the regulations, these breeders have cannot obtain an USDA license.

USDA notes that the “four or fewer exemption” has been in place since 2004 (addressing a comment related to licensure of small exotic and wild animal owners), there was no discussion about the growing impact to dog “hobby” breeders, perhaps because no one submitted a relevant comment.  (There was a comment that permitting these breeders to go unlicensed created a loophole, but USDA “made no changes in response to that comment”).

If these breeders were to try to use third party certifiers to prove to the public that it complies with or exceeds standards required pursuant to the AWA, the reliance on such certification may be questioned based on USDA’s recent announcement that it “will not establish new criteria for recognizing third-party inspection and certification programs when determining the Agency’s own inspection frequency under the Animal Welfare Act (AWA).”

USDA explained:

In this case, APHIS found the vast majority of the comments we received to not be in favor of establishing new criteria for recognizing third party inspection and certification programs.  Stakeholders on all sides of the issue expressed concern about APHIS’ ability to maintain responsibility for inspections and AWA compliance should third-party inspections be taken into account when determining APHIS inspection frequencies.

APHIS will continue to use its current risk-based inspection system to determine the frequency of inspections, and will continue to promote compliance with the AWA by conducting quality inspections, offering voluntary compliance support and learning opportunities, and taking enforcement action, as appropriate.

Still, no one should be surprised if activists use USDA’s decision to support their unsubstantiated position that certain third party certifications are meaningless.

While it is understandable that USDA has adopted this rule to “allow . . . APHIS to focus its limited resources on situations that pose a higher risk to animal welfare and public safety” I hope that these exemptions do not create additional hardships for animal owners, breeders, and exhibitors.  More to follow in PART TWO.

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.

 

 

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.

California AB485 will criminalize what has been considered lawful interstate commerce since at least 1966, when Congress first passed the Animal Welfare Act, 7. U.S.C. §2131 et seq.

“The Congress finds that animals and activities which are regulated under this chapter are either in interstate or foreign commerce or substantially affect such commerce or the free flow thereof, and that regulation of animals and activities as provided in this chapter is necessary to prevent and eliminate burdens upon such commerce and to effectively regulate such commerce, in order – (1) to insure that animals intended . . . for use as pets are provided humane care and treatment . . .”  7 U.S.C. §2131 (Congressional statement of policy).

Pet stores in California will no longer be able to purchase and sell pets from USDA licensed and exempts breeders and dealers of dogs, cats and rabbits if AB485 becomes law.  Instead, pet store would only be able to source from the highly unregulated animal shelters and rescue organizations that distribute pets from random sources, often imported from overseas, and often infected or infested with diseases or pests that unwitting consumers have to contend with and pay for.

Pet stores that have provided a historic and lawful service matching up pet-seeking owners with professionally and purposely-bred pets with the physical and behavioral characteristics perspective owners desire, would be considered criminals under the new California law, upon adoption.

Unfortunately, this is no longer a novel attempt by nonprofit animal rights organizations’ decades-long campaign to eliminate professional, purposeful dog breeding, along with animal ownership (replaced with guardianship) and a host of other animal rights’ agenda.

The question is, when will consumers realize that their choices in pet purchases have been supplanted by activists who believe that pet breeding (and the intentional breeding of any species) is immoral and should be outlawed.

The public, clamoring for the 9,000,000 dogs needed each year for pet-owners seeking new pets, will soon have their choices severely limited.

What a sad state of affairs for pets and people alike and as we have repeatedly alleged, unconstitutional.

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.

The Animal Welfare Act (AWA) has been disemboweled by local jurisdictions around the country that have banned sales to pet shops from USDA licensees and those specifically exempted from licensure, which shops rely upon to provide healthy puppies to people choosing to purchase a specially-bred puppy with specific physical and behavioral traits best suited to that pet owner’s particular needs.

Beginning around 2008, animal rights organizations began persuading lawmakers to implement decades-long campaigns to eliminate commercial dog breeding by banning sales of puppies in pet shops that they claim are sourced from “puppy mills,” a pejorative term used for any dog breeder, licensed or not. At their urging, lawmakers in many jurisdictions have limited pet shops to sales of animals sourced from shelters and rescues, which are largely unregulated entities that transfer ownership of randomly sourced dogs that have an unacceptably high prevalence of infectious diseases and other disorders.

While the AWA permits local jurisdictions to adopt more rigorous standards of care than the law prescribes, the bans have gone too far—in many cases sales are banned from USDA licensees based solely on the existence of validly held licenses. Sourcing bans that are not based on the standards of care licensees provide to animals should be considered pre-empted by the AWA. Reliance on the mere citation of a violation of the AWA on an inspection report as the basis for such bans is not legally sound. Congress established the mechanisms for licensure and loss thereof, which these local laws ignore.

Through the adoption of as over 150 laws across the country, the animal health and welfare requirements set forth by Congress in the AWA to protect animals and people have been effectively removed. If such laws are not enjoined, they will cumulatively render the federal regulation superfluous to the local sales bans or, at best, be subject to a labyrinthine patchwork of local regulation. This is precisely the situation the Framers of the Constitution sought to avoid through the Supremacy Clause.

Under the false banner of humane care and consumer protection, these bans will harm animals, their owners, and create a public health risk through the introduction of infectious diseases, which, like rabies, are fatal. If these local laws are not enjoined, they will eliminate the market that Congress has sought to regulate through the AWA. This cannot be a proper result.