Comment submitted by The Tennessee Center for Bioethics & Culture

Docket ID Number EPA-HQ-OW-2022-0946 To Jessica L. Kramer, Assistant Administrator, EPA: Thank you for your invaluable work to the United States, especially the role of the EPA in keeping our nation’s water supply safe to drink. A number of years ago, I spoke with the engineer in charge of the water supply for a major U.S. metropolitan area. I asked her what was one of the most important challenges to clean water. Her answer surprised me: removal of hormones from water. This is exacerbated by the fact that so many people take some form of estrogen or testosterone, she added. Mifepristone is a drug that interrupts cortisol and progesterone hormone activity at the receptor level (https://www.ncbi.nlm.nih.gov/books/NBK557612/). Persons with Cushing syndrome use the drug to treat hyperglycemia. Now the drug mifepristone (formerly known as RU-486) is available by mail for abortion in the United States. Millions of women have used it since its approval by the FDA in 2000 (https://www.ansirh.org/research/brief/analysis-medication-abortion-risk-and-fda-report-mifepristone-us-post-marketing). What happens to the waste from its use: excretion by the people using it, and any resulting embryonic or fetal elements flushed into our waterways? How much of it enters our water supply? In what ways are humans, fish, and other animals affected by the presence of this drug and its metabolites? According to the EPA’s website (https://www.epa.gov/endocrine-disruption/overview-endocrine-disruption), research “suggests that environmental contaminants can disrupt the endocrine system, leading to adverse health consequences.” Further, the EPA’s “Overview of Endocrine Disruption” states, “It is important to gain a better understanding of what concentrations of chemicals found in the environment may cause an adverse effect.” Since the diethylstilbestrol (DES) debacle, the article continues, “Congress has improved the evaluation and regulation of drugs and other chemicals. The statutory requirement to establish an endocrine disruptor screening program is a highly significant step.” An endocrine disruptor screening program is indeed a highly significant step. Since mifepristone is an endocrine disruptor, it seems essential (and only rational) to include it in the screening program. We at The Tennessee Center for Bioethics & Culture urge you to add mifepristone to the list of pharmaceuticals under EPA testing consideration as part of the contaminants of concern review. Sincerely, D. Joy Riley, M.D., M.A. Executive Director