Federal

US - Research - Roadmap to Reducing Animal Testing in Preclinical Safety Studies

Summary: Executive Summary: This roadmap outlines a strategic, stepwise approach for FDA to reduce animal testing in preclinical safety studies with scientifically validated new approach methodologies (NAMs), such as organ-on-a-chip systems, computational modeling, and advanced in vitro assays. By partnering with federal agencies like NIH and VA through ICCVAM, FDA can accelerate the validation and adoption of these human-relevant methods, improving predictive accuracy while reducing animal use. This transition will enhance public health by streamlining drug development and ensuring safer therapies reach patients faster, while positioning FDA as a global leader in modern regulatory science and innovation.

Fabrizius v. Dep't of Agric.

Summary: The Tenth Circuit denied a petition for review filed by Jason Fabrizius and Fabrizius Livestock LLC, affirming a $210,000 civil penalty imposed by the USDA for violations of the Animal Health Protection Act (7 U.S.C. §§ 8301-8322) and implementing regulations (9 C.F.R. §§ 71.3, 86.5), as well as the Commercial Transportation of Equine for Slaughter Act (7 U.S.C. § 1901 note) and its regulations (9 C.F.R. §§ 88.4, 88.6). The case involved Fabrizius's interstate sales of horses, many destined for slaughter, without required health documentation. The violations included: (1) transporting 14 horses without owner-shipper certificates required by CTESA to ensure humane transport conditions; (2) selling 50 horses across state lines without Interstate Certificates of Veterinary Inspection (ICVIs) mandated by AHPA regulations for disease tracking; and (3) selling an EIA-positive horse that triggered a multi-state disease investigation, with 67 exposed horses remaining untraceable. The court upheld the USDA’s determination that Fabrizius Livestock qualified as a "person responsible" under 9 C.F.R. § 86.5(a), rejecting constitutional vagueness and due process challenges, as the regulatory language provided fair notice and encompassed sellers who knowingly facilitated interstate movement. The court also found the penalty neither arbitrary nor excessive under the Eighth Amendment, deferring to the agency’s consideration of statutory factors, including the violations’ gravity, Fabrizius’s experience in the industry, and the potential economic and health risks posed by the undocumented horse movements. The decision reinforces broad agency discretion in enforcing animal health regulations and affirms that civil penalties need not be mathematically precise so long as they are proportionate to the violations and supported by reasoned analysis.

Reaves v. Immediate Med. Care, P.A.

Summary: The United States District Court adjudicated a claim brought by Erin Reaves, an individual with diagnosed post-traumatic stress disorder, anxiety, and bipolar disorder, against Immediate Medical Care, P.A., a medical clinic in Jacksonville, Florida. Reaves alleged that the clinic violated Title III of the Americans with Disabilities Act (ADA) when staff refused to allow her service dog, Malia—a trained animal that assisted with her psychiatric disabilities—to accompany her during a scheduled April 2023 medical appointment. The clinic based its refusal on the severe dog allergies of one of its physicians, Dr. Gargin, and offered alternative accommodations, including seeing a different doctor or having the dog wait outside. After a three-day bench trial, the court found that while Reaves was disabled under the ADA and Malia qualified as a service animal, Immediate Medical Care had lawfully excluded the dog under the ADA’s "direct threat" exception. The court credited evidence that Dr. Gargin’s allergy posed a genuine health risk, noted that the clinic had conducted an individualized assessment under 28 C.F.R. § 36.208(b), and emphasized that reasonable modifications—such as rescheduling with another provider—had been offered. Accordingly, the court entered judgment in favor of Immediate Medical Care, holding that a public accommodation may exclude a service animal when objective evidence shows it would endanger another’s health and alternative accommodations are available.

US - Endangered Species - Subpart B. § 17.11 Endangered and threatened wildlife

Summary: The list in this section contains the names of all species of wildlife which have been determined by the Services to be Endangered or Threatened. It also contains the names of species of wildlife treated as Endangered or Threatened because they are sufficiently similar in appearance to Endangered or Threatened species.

Just Puppies, Inc. v. Brown

Summary: The plaintiffs, including retail pet stores and a USDA-licensed breeder, challenged Maryland's 2021 Pet Store Statute, which prohibits retail pet stores from selling or transferring dogs and cats, alleging it conflicts with the federal Animal Welfare Act (AWA) and violates the Commerce Clause. The Pet Store Statute aims to curb the sale of dogs from "puppy mills" by banning retail pet stores and brokers from selling dogs, while exempting breeders who sell animals born at their establishments. Plaintiffs argued that the statute effectively shifts dog sales from regulated retail pet stores sourcing from out-of-state breeders to unregulated internet sales and local breeders, undermining the AWA's regulatory framework. The AWA establishes federal standards for the humane treatment of animals, including licensing requirements for breeders and brokers, but explicitly allows states to enact additional animal welfare regulations. The court rejected plaintiffs' claim that the AWA preempts the Pet Store Statute, finding no conflict because the AWA does not occupy the field of animal welfare regulation and permits concurrent state laws. Plaintiffs also argued that the statute obstructs the AWA's objectives by eliminating USDA-licensed brokers from the Maryland market, but the court found no evidence that the statute impedes federal licensing or inspection processes. The court dismissed plaintiffs' Commerce Clause claims, finding no discriminatory purpose or effect against out-of-state breeders, as the statute applies equally to in-state and out-of-state entities and does not prohibit interstate sales. The statute allows out-of-state breeders to sell directly to Maryland consumers, either in person or online, and does not regulate sales occurring wholly outside Maryland. The court upheld the statute's legitimacy, recognizing Maryland's interest in addressing puppy mills, protecting consumers from unhealthy animals, and reducing shelter populations, which are valid state police powers. The court affirmed the dismissal of the complaint, concluding that the Pet Store Statute is not preempted by the AWA and does not violate the Commerce Clause, as it regulates animal welfare within Maryland's traditional authority. The judgment of the district court was affirmed.

Animal Legal Def. Fund, Inc. v. Vilsack

Summary: The Animal Legal Defense Fund (ALDF) sued the U.S. Department of Agriculture (USDA) for declaratory and injunctive relief alleging that the USDA violated the Poultry Products Inspection Act (PPIA) and the Administrative Procedure Act (APA) by approving the labels for Perdue's “Fresh Line” chicken and turkey products. Specifically, ALDF claims that the USDA adopted a policy of evaluating only the text and not any graphics that appear on poultry-product labels. Fresh Line chickens and turkeys were raised strictly indoors and the approved product labels depict birds freely roaming outside a barn. ALDF asked the Department to reject any Perdue labels containing that kind of imagery because they claim the imagery misleads consumers into thinking the birds were raised in pastures, when they in fact spent the entirety of their lives in overcrowded warehouses. The Food Safety and Inspection Service (FSIS) has been delegated to enforce the PPIA labeling requirements and rejected ALDF's request to reject Fresh Line's "misleading" labels. After denial, the ALDF sued the USDA and FSIS, alleging the Fresh Line labels violated the PPIA and APA and that FSIS has a "pattern and practice" of not reviewing such graphical imagery on poultry-label products. The government moved to dismiss both claims and the district court agreed, finding ALDF lacks both organizational and associational standing. On appeal here of only associational standing, this court found that the member who was harmed cannot show a substantial likelihood that the member will suffer non-self-imposed harm in the future. In other words, the court was not convinced that the consumer member will continue to purchase the product in the future now that she knows the label is misleading. As to ALDF's claim that FSIS' policy of not reviewing imagery on poultry labels also harms the member because it causes a "lack of confidence" in any chicken labels, the court found that injury was sufficiently concrete. However, the member did not have an ongoing or imminent injury because there was no proof presented that there were other products that exist or will exist with this labeling issue. The district court's dismissal was affirmed.

Johnson v. Smith

Summary: Scott Johnson and Harlene Hoyt, the plaintiffs, challenge the constitutionality of the Kansas Pet Animal Act (the Act), which authorizes warrantless inspections of their homestead, where Mr. Johnson operates a business housing and training bird dogs. They argue that the Act violates the Fourth Amendment by permitting warrantless inspections and infringes on their constitutional right to travel by requiring premises to be made available for inspection within 30 minutes of an inspector’s arrival. The United States District Court for the District of Kansas granted the state’s motion to dismiss, prompting the plaintiffs to appeal. The court analyzed the Act, noting that it imposes varying inspection requirements and housing standards on different licensees, with all licensees subject to initial and routine inspections “at reasonable times.” Refusal to permit inspections constitutes grounds for license suspension or revocation. The court then examined whether the Act violates the Fourth Amendment, applying precedent from Burger and subsequent cases. It identified relevant factors for determining whether an industry is closely regulated, including the history of warrantless inspections, the extensiveness of the regulatory scheme, whether similar schemes exist in other jurisdictions, and the potential threat to public welfare if left unregulated. The parties disputed whether Mr. Johnson’s business qualifies as part of a closely regulated industry. The court credited the plaintiffs’ allegation that training kennels are distinct from other animal-related operations, noting that Kansas treats them as a separate category requiring specific licenses. The court concluded that the boarding or training-kennel industry does not qualify as closely regulated under the Fourth Amendment’s narrow exception for warrantless inspections. It emphasized the industry’s lack of a long tradition of regulation and found that the regulatory scheme does not clearly inform industry participants of unannounced warrantless inspections. Applying Patel, the court held that the regulatory scheme must satisfy three criteria for warrantless searches to be reasonable: a substantial government interest, necessity of warrantless inspections to further the regulatory scheme, and a constitutionally adequate substitute for a warrant. The court found that dismissal of the plaintiffs’ Fourth Amendment claim was improper, as the complaint did not establish that the closely regulated industry exception applies or that the Burger factors were satisfied. It also reversed the dismissal of the claim that the Act unconstitutionally conditions licensure on waiving Fourth Amendment rights. However, the court affirmed that the 30-minute inspection availability requirement does not violate the constitutional right to travel. The judgment was affirmed in part, reversed in part, and remanded.

Nantucket Residents Against Turbines v. U.S. Bureau of Ocean Energy Mgmt.

Summary: In this case, the U.S. Bureau of Ocean Energy Management (“BOEM”) approved the construction of Vineyard Wind, a wind power project off the coast of Massachusetts after consulting with the National Marine Fisheries Service (“NMFS”). A group of Nantucket residents, organized as "Nantucket Residents Against Turbines" (“Residents”), allege that the federal agencies violated the Endangered Species Act by concluding that the project's construction likely would not jeopardize the critically endangered North Atlantic right whale. The United States District Court for the District of Massachusetts granted summary judgment for BOEM and NMFS. On appeal of summary judgment, the Residents further allege that BOEM violated the National Environmental Policy Act by relying on NMFS's flawed analysis. The court rejected the Residents' argument, finding that NMFS's biological opinion properly analyzed the current status and environmental baseline of the right whale. Further, the biological opinion properly analyzed the effects of the project (e.g., noise) on the right whale, along with mitigation measures, and did not ignore the project's additive effects on the right whale's long-term recovery prospects. Finally, BOEM's reliance on the biological opinion did not violate NEPA. The judgment of the district court was affirmed.

Denise Venero v. Prince George's County Maryland

Summary: Plaintiffs filed this putative class action to challenge the Prince George's County, Maryland Pit Bull Ordinance and enforcement of the ordinance. Plaintiffs assert multiple due process and equal protection claims in violation of the Fourteenth Amendment, as well as several violations of the Fair Housing Act. The ordinance bans the keeping of pit bull terriers in the county, and requires any pit bull owners at the time the ordinance was adopted to register the dog, pay a fee, maintain a secure kennel, and keep the dog secure at all times. The court in this case found that the plaintiffs lack standing, since they could not show an injury in fact relating to the county's enforcement of the ordinance, the county has returned seized dogs to the plaintiffs, and the plaintiffs have been afforded due process through the county's administrative process.

Center for Biological Diversity v. Little

Summary: This case was brought by plaintiffs to challenge an Idaho law that authorizes wolf trapping and snaring in grizzly bear habitat. Plaintiffs argue that the authorization of this trapping activity will lead to the unlawful taking of grizzly bears, in violation of the Endangered Species Act (ESA). Plaintiffs seek to enjoin the state's authorization of trapping in these areas until the state obtains an incidental take permit from the US Fish and Wildlife Service. The court found that there was ample evidence to show that that lawfully set wolf traps and snares are reasonably likely to take grizzly bears in Idaho. However, the court did not find sufficient evidence to show that trapping needs to be banned year round to protect grizzly bears in the state. Accordingly the court granted the injunction, but limited it to the period when grizzly bears are reasonably certain to be out of their dens.