Law and Policies Effect on EPA Work Plans and Non-Animal Vertebrate Timeline

By Andrea Uhlig | October 12, 2023

Government agencies, such as the Environmental Protection Agency (EPA), make regulatory decisions based on laws set by Congress, and policies put in place by past or current administrations. These decisions influence how science moves forward, in this instance toxicological studies non-vertebrate animal models. In 2016, the Frank R. Lautenberg Chemical Safety for the 21st Century Act was put into place to update the Toxic Substance Control Act. Under section 4(h)(1) “Reduction of Testing on Vertebrates” of the Lautenberg Act, the EPA Administrator can reduce reliance on vertebrate animal testing. Section 4(h)(2) gives the EPA instructions to implement alternative testing methods with deadlines for a strategic plan.

EPA can create or change policies to accommodate the requirements in the Lautenberg Act or for other purposes. In 2019, EPA Administrator Andrew Wheeler issued a directive which, among other things, sought to eliminate mammal testing if feasible by 2035. In June 2020 the EPA published a New Approach Methods Work Plan highlighting Administrator Wheeler’s directive and this 2035 goal. Toward the end of 2021, the EPA published an updated New Approach Methods Work Plan that deleted the goal to eliminate mammalian testing by 2035 and changed the language pertaining to animals from “mammals” and “non mammal” to “vertebrate animals” and “non-vertebrate animals.” The updated NAMs Work Plan also included updated deliverable dates, pushing many deadlines back one to two years. According to the EPA, these changes better match the goals and language created in the Lautenberg Act. While the shift from mammals to specifically “vertebrate animals” seems like a necessary change to follow the Lautenberg Act, the abandonment of the 2035 aspirational deadline raises questions (1) about EPA’s commitment to non-animal testing methods and (2) whether this policy change will impact the science and research done in offices within the EPA.

According to the FY2023 budget request of the US Government relating to the “EPA Implementation of the Lautenberg Act, $124 million and 449 FTE (full-time equivalent) could be dedicated to implementation of the Lautenberg Act.  In the FY 2022 Department of the Interior, Environment, and Related Agencies Appropriations Bill, EPA was instructed to report to Congress their efforts to use more New Approach Methodologies (NAMs) to replace vertebrate animals. Congress also urged the EPA to expedite its timeline to end the use of mammalian testing, although the EPA Work Plan deadlines have become more relaxed.

To fulfill Congressional requests and meet public demands EPA must focus on phasing out vertebrate animal testing while at the same time producing better scientific methods for decision-making.  The government must continue to fund and drive EPA to use and develop NAMs.

The views expressed do not necessarily reflect the official policy or position of Johns Hopkins University or Johns Hopkins Bloomberg School of Public Health.