EPA Research Contributes to Using Alternatives to Screen Chemicals for Endocrine Disruption

Published February 2, 2023

EPA’s Office of Pesticide and Pollution Prevention (OCSPP) announced the release of a draft White Paper Availability of New Approach Methodologies (NAMs) in the Endocrine Disruptor Screening Program (EDSP) for public comment via the Federal Register. The paper describes validated NAMs that could be used as alternatives for certain EDSP tests.

Researchers in EPA’s Office of Research and Development (ORD) working on NAMs developed the estrogen receptor (ER) pathway model and contributed to the development of the androgen receptor (AR) pathway model. The ER pathway model is described in Judson et al. 2015 and was presented during a 2014 Scientific Advisory Panel meeting. The AR model is described in Kleinstreuer et al. 2016 and was reviewed during a 2017 Scientific Advisory Panel meeting. These models use high-throughput screening assays to measure chemical effects on estrogen and androgen receptors.

What is Endocrine Disruption?

Endocrine systems, also referred to as hormone systems, are found in all mammals, birds, fish, and many other living organisms. Many hormones are included in the endocrine system. Hormones regulate a diverse array of important physiological functions such as growth, development, reproduction, energy metabolism, and blood pressure. Examples of hormones include estrogen, testosterone, and thyroid hormone. Some chemicals called “endocrine disrupting chemicals” are of particular concern as these chemicals can interfere with the normal functions of the endocrine system and lead to problems with reproduction (i.e., egg and sperm production).

What are NAMs?

NAMs are defined as any technology, methodology, approach, or combination that can provide information on chemical hazard and risk assessment to avoid the use of animal testing. EPA is prioritizing ongoing efforts to develop and use NAMs to test chemicals, including endocrine disruptors as part of the EDSP, for health effects. These NAMs will allow EPA to screen chemicals faster, more efficiently, and ultimately provide better data using alternatives to vertebrate animal testing and other in vitro, or “in-the-laboratory", assays.

White Paper Public Comments

Public comments on the draft White Paper will be accepted for 60 days in docket ID number EPA-HQ-OPP-2021-0756 at www.regulations.gov. After considering public comments, EPA will issue a finalized document.  

Learn more

Read more about OCSPP’s announcement about the White Paper.

Learn more about New Approach Methodologies (NAMS) on the EPA NAMs Research page.

Learn more about the Use of High Throughput Assays and Computational Tools in the Endocrine Disruptor Screening Program.