EPA plans to reduce animal testing

Environmental Protection Agency officials plan to reduce the use of animals in studies assessing the risks of pesticides and other potentially hazardous chemicals.

Alternatives include in vitro studies on human or animal cells, organ-on-a-chip models, and computer-based models.

Under a directive from EPA Administrator Andrew Wheeler, agency officials will reduce requests for and funding of studies that use mammals by 30% by 2025 and allow them only in exceptional cases by 2035. The agency is giving $4.25 million toward research on ways to reduce, refine, and replace testing on vertebrate species.

Pesticide makers have to test their products for effects on humans and the environment before they're allowed to sell them in the U.S., and that currently includes tests on animals such as rats, mice, rabbits, dogs, birds, and fish. EPA officials evaluate the resulting data and decide whether to grant product registration.

An EPA spokesperson provided a statement that laboratory animal testing gives a sense whether pesticides and patterns of use could cause maladies such as cancer, chronic disease, or reproductive and developmental toxicities. Pesticides may be tested on hundreds to thousands of vertebrates, depending on the toxicity and complexity of the chemicals.

The number of vertebrates used in toxicology studies submitted to the EPA each year ranges from 20,000 to more than 100,000, an agency spokesperson said. In 2017 and 2018, the EPA granted waivers that prevented use of about 57,000 animals over those two years and reduced costs by about $19 million.

Wheeler described the timetable for the planned reductions in a Sept. 10 memo to EPA staff, and agency officials published an announcement that day. The action follows legislation and previous agency actions with similar goals.

A law signed in June 2016, the Frank R. Lautenberg Chemical Safety for the 21st Century Act, requires that the EPA minimize use of vertebrates in chemical safety testing as well as study and promote alternatives. Agency officials published a reduction plan two years later, and an agency plan for fiscal years 2018-22 also expresses commitment to reducing reliance on animal testing.

Wheeler, in his memo, said those actions together have prevented research on an estimated 200,000 animals.

Dr. Joe Thulin, director of the Biomedical Resource Center at the Medical College of Wisconsin and president of the American College of Laboratory Animal Medicine, said nobody wants to use animals in research when they are unneeded. But he questioned whether nonanimal technologies will be reliable enough by the deadlines to replace animals, especially as surrogates for humans.

He also questioned whether the decision is based in science, rather than efforts to appease animal rights advocates. Dr. Thulin stressed that everyone wants to give animals the best care and eliminate unnecessary use.

Dr. David C. Dorman is president of the American Board of Veterinary Toxicology, a member of the National Academy of Science's Board on Environmental Studies and Toxicology, and a professor of toxicology at North Carolina State University College of Veterinary Medicine. He said the NAS board discussed the EPA plan, which is consistent with some efforts by toxicologists for more than a decade to reduce reliance on animal testing.

Board members had concerns about the timeline set by the directive and whether the agency will impose firm deadlines on reducing animal use. Dr. Dorman expressed doubt that alternatives will be robust enough to replace all the studies described.

But Dr. Dorman said the directive also sets a goal and focuses attention, much as emissions limits and fuel efficiency standards do.

The grants from the EPA will fund studies at Johns Hopkins University to create a model for assessing developmental neurotoxicosis in humans, Vanderbilt University to test an organ-on-a-chip model to study damage caused by organophosphate leakage across the blood-brain barrier and the university's medical center to use those chips to study reproductive disorders in women and cellular responses to environmental toxicants, Oregon State University to test in vitro methods that incorporate fish to screen complex mixtures of chemicals, and the University of California-Riverside to create an inexpensive test that uses human cells to analyze possible skeletal embryotoxicants.