Brooks Law Digest: Animal Testing/Research

The FDA Modernization Act , which has been pending in the U.S. House of Representatives since April 2021 (H.R. 2565), has now been introduced in the Senate. The bill would amend the federal Food, Drug, & Cosmetic Act by allowing alternatives to animal testing during the development of new drugs. Since 1962, the FDA has required that experimental drugs first be tested on animals before being used on humans in clinical trials. The Senate bill has been introduced by Senators Cory Booker and Rand Paul and currently is co-sponsored by Senators Mike Braun, John Kennedy, and Ben Ray Lujan.

PETA has filed suit against the National Institutes of Health (NIH), NIH Director Francis Collins, the Department of Health and Human Services (HHS), and HHS Secretary Xavier Becerra alleging that the agency violated the Administrative Procedure Act when it continued to fund sepsis experiments on animals despite NIH’s acknowledgement that mice are not a suitable substitute for humans in these experiments. The complaint states that the NIH has spent “more than $20 million for new [animal-sepsis] projects in the past twenty months and at least $10 million for new projects in fiscal year 2021.” PETA argues this funding is a waste of taxpayer money and violates NIH’s obligation to fund research to improve human health and minimize the number of animals used in research.

H.R. 5244, the “Animal Freedom from Testing, Experiments, and Research (AFTER) Act of 2021” would amend the Animal Welfare Act to direct all federal research facilities to promulgate standards to facilitate the adoption of certain animals used in federal research, or their “non-laboratory placement” with an animal rescue organization, animal sanctuary, or animal shelter. The bill has been referred to the House Committee on Agriculture and is sponsored by Reps. Brendan Boyle and Nancy Mace.

People for the Ethical Treatment of Animals (PETA) and the Animal Legal Defense Fund have filed a lawsuit in the U.S. District Court for the District of Columbia seeking to stop the National Institutes of Health (NIH) and the U.S. Department of Health and Human Services (HHS) from automatically blocking comments containing keywords associated with viewpoints critical of animal testing on the agencies’ social media pages. The lawsuit alleges that the NIH and HHS Facebook and Instagram pages, which are open for comments from the general public, are public forums and that the agency’s practice is an unconstitutional content-based restriction. Plaintiffs are represented by the Knight 1st Amendment Institute at Columbia University.

The Mexico Senate has unanimously approved (103-0) a decree prohibiting the use of animals in cosmetic product experiments. The legislation will reform the General Law of Health by prohibiting testing of individual cosmetic ingredients or finished cosmetic products on animals, as well as banning the import, manufacture, or sales of products that have been tested on animals. The penalties for violation include substantial fines and prison sentences of two to seven years. The bill will become law after ratification by the federal executive power and publication in the Official Gazette of the Federation, at which time Mexico will make history as the first North American country to ban animal testing for cosmetic purposes.

The White Coat Waste Project has sued the United States Department of Agriculture under the Freedom of Information Act for “emails (including their attachments), memos, letters, PowerPoint presentations, reports and meeting minutes regarding feline euthanasia, feline retirement and/or feline transfer from the Beltsville Agricultural Research Center (January 1, 2019-August 1, 2019)” and “materials related to all approved research involving dogs performed by, or in conjunction with, the U.S. Department of Agriculture.”

Michigan House Bill 582 would prohibit individuals employed by, contracted by, or otherwise directed to take action on behalf of a public body from conducting a research or training activity on a dog in a manner that causes pain or distress. The bill also would prohibit such individuals from breeding, purchasing, transporting, housing, feeding, or maintaining a dog for use in a research or training activity that causes pain or distress. The prohibition would not apply when a dog owner consents to the use of his or her dog in veterinary training or veterinary clinical research involving the necessary treatment of an existing disease or ailment, nor to spay/neuter procedures by a veterinarian or animal shelter.

The Animal and Plant Health Inspection Service has proposed revisions to the requirements for research facilities and dealers, exhibitors, intermediate handlers, and carriers for contingency planning and training of personnel. By lifting an internal stay that has been in place since 2013, the agency states the revisions “would better ensure that entities responsible for animals regulated under the Animal Welfare Act are prepared to safeguard the health and welfare of such animals in the event of possible emergencies or disasters.” The agency is accepting comments on the proposal until August 24, 2021.

House Bill 4101, the Humane and Existing Alternatives in Research and Testing Sciences (HEARTS) Act, would direct the National Institutes of Health to ensure that non-animal methods are prioritized in proposals for all research funded by the agency. This would be accomplished by establishing incentives for non-animal research and testing and fully evaluating non-animal alternatives. The bill was previously introduced in 2019.

Maine Governor Janet Mills signed into law House Bill 1156 which will prohibit a manufacturer from selling or offering for sale in the state a cosmetic that was developed or manufactured using cosmetic animal testing conducted or contracted for on or after November 1, 2021.