As part of the U.S. Environmental Protection Agency’s (EPA) extensive efforts to help communities address per- and polyfluoroalkyl substances (PFAS) under the PFAS Action Plan, last week the Agency released the Systematic Review Protocol for five PFAS toxicity assessments for a 45-day public comment period. The assessments are being developed under the Integrated Risk Information System (IRIS) Program. In addition to this assessment, EPA took an important step in September by sending two regulatory proposals on PFAS for interagency review. By the end of the year, EPA will issue its proposed regulatory determination for PFOA and PFAS which is the next step in the drinking water standard setting process outlined in the Safe Drinking Water Act (SDWA).

“EPA is following through on its commitment under the PFAS Action Plan to begin the IRIS process to identify the public health risks associated with a new set of PFAS,” said EPA Administrator Andrew Wheeler. “Today’s action seeks the public’s input on our approach to address five individual PFAS. This is another step in EPA’s commitment to proactively, and collaboratively tackle PFAS and provide the necessary tools to assist our communities with the tools and information they need to better monitor, detect and address PFAS.”

The Systematic Review Protocol EPA is issuing today is not a toxicity assessment itself, instead it describes how the five IRIS assessments will be conducted, including specific procedures and approaches. The five PFAS EPA is focusing on under this protocol are: perfluorodecanoic acid (PFDA), perfluorononanoic acid (PFNA), perfluorohexanoic acid (PFHxA), perfluorohexanesulfonate (PFHxS), and perfluorobutanoic acid (PFBA). Though the Systematic Review Protocol summarizes the methods in one document, there will be five separate IRIS assessments.

The IRIS assessments will identify the potential human health effects from exposure to each assessed PFAS and will develop toxicity values, as supported by the available evidence. Depending on data availability, the assessments will evaluate both cancer and noncancer effects, including potential effects on the endocrine, hepatic, urinary, immune, developmental, and reproductive systems. Systematic review protocols are released early in the IRIS assessment development process as an added effort to increase transparency, and to allow the public and stakeholders to understand how an assessment will be conducted. This includes defining what procedures will be used and describing any anticipated areas of scientific complexity that will be important to address in the toxicity assessment.

This Systematic Review Protocol will be available for a 45-day public comment period. Public input received on the protocol is considered during preparation of the draft assessments and any adjustments made to the protocol will be reflected in an updated version released in conjunction with the public release of the draft assessments.

Additional information:  https://www.federalregister.gov/documents/2019/11/08/2019-24350/availability-of-the-systematic-review-protocol-for-the-pfda-pfna-pfhxa-pfhxs-and-pfba-iris

Background

PFAS are a large group of man-made chemicals composed of one or more carbon atoms on which all hydrogen substituents have been replaced with fluorine atoms. The compounds are used in consumer products and industrial processes. In use since the 1940s, PFAS are resistant to heat, oils, stains, grease, and water—properties which contribute to their persistence in the environment.

The agency’s PFAS Action Plan is the first multi-media, multi-program, national research, management and risk communication plan to address a challenge like PFAS. The plan responds to the extensive public input the agency has received over the past year during the PFAS National Leadership Summit, multiple community engagements, and through the public docket. The PFAS Action Plan outlines the tools EPA is developing to assist states, tribes, and communities in addressing PFAS.

EPA continues to make progress under its PFAS Action Plan to protect the environment and human health. To date, EPA has:

Highlighted Action: Drinking Water

• EPA is committed to following the national primary drinking water regulation rulemaking process as established by the Safe Drinking Water Act (SDWA).
• As a next step, EPA will propose a regulatory determination for PFOA and PFOS by the end of this year.
• The Agency is also gathering and evaluating information to determine if regulation is appropriate for other chemicals in the PFAS family.

Highlighted Action: Cleanup

• On June 10, 2019, EPA concluded public comment on the draft Interim Recommendations for Addressing Groundwater Contaminated with PFOA and PFOS, when finalized it will provide cleanup guidance for federal cleanup programs (e.g., CERCLA and RCRA) that will be helpful to states and tribes.
• EPA is initiating the regulatory development process for listing certain PFAS as hazardous substances under CERCLA.

Highlighted Action: Monitoring

• EPA will propose nationwide drinking water monitoring for PFAS under the next UCMR monitoring cycle.

Highlighted Action: Toxics

• The agency recently sent two actions that address per- and polyfluoroalkyl substances (PFAS) to the Office of Management and Budget for interagency review.
• Advanced notice of proposed rulemaking that would allow the public to provide input on adding PFAS to the Toxics Release Inventory toxic chemical list.
•  A supplemental proposal to ensure that certain persistent long-chain PFAS chemicals cannot be manufactured in or imported into the United States without notification and review under the TSCA.

Highlighted Action: Surface Water Protection

• EPA plans to develop national Clean Water Act human health and aquatic life criteria for PFAS, as data allows.
• EPA is examining available information about PFAS released into surface waters by industrial sources to determine if additional study is needed for potential regulation.

Highlighted Action: Biosolids

• EPA will be developing risk assessments for PFOA and PFOS to understand any potential health impacts.

Highlighted Action: Research

• EPA continues to compile and assess human and ecological toxicity information on PFAS to support risk management decisions.
• EPA continues to develop new methods to test for additional PFAS in drinking water.
• The Agency is also validating analytical methods for surface water, ground water, wastewater, soils, sediments and biosolids; developing new methods to test for PFAS in air and emissions; and improving laboratory methods to discover unknown PFAS.
• EPA is developing exposure models to understand how PFAS moves through the environment to impact people and ecosystems.
• EPA continues to assess and review treatment methods for removing PFAS in drinking water.
• EPA is working to develop tools to assist officials with the cleanup of contaminated sites.
• EPA is evaluating the effectiveness technologies and evaluating data on methods for managing the end-of life disposal of PFAS-contaminated materials.

Highlighted Action: Enforcement

• EPA uses enforcement tools, when appropriate, to address PFAS exposure in the environment and assists states in enforcement activities.

Highlighted Action: Risk Communications

• EPA will work collaboratively to develop a risk communication toolbox that includes multi-media materials and messaging for federal, state, tribal, and local partners to use with the public.

Attorney General Curtis Hill has asked a federal district court to reject challenges brought by the Whole Woman’s Health Alliance (WWHA) and affiliated co-plaintiffs against Indiana laws designed to protect women seeking abortions.

“Unsurprisingly,” Attorney General Hill said, “there are not among the plaintiffs any pregnant women seeking to invalidate such safeguards. Plaintiffs attack nearly every Indiana abortion statute and regulation — from licensing to physical examination — including some that do not even affect them. And while plaintiffs invoke the rights of patients, their interests as abortion providers diverge from pregnant women.”

WWHA operates a South Bend clinic that provides medication abortions, in which patients are provided medications that cause fetal death and then cause the patients to expel the deceased fetuses after they leave the clinic.

Key arguments put forward by Attorney General Hill challenge the plaintiffs’ standing to sue, and Hill laments that WWHA treats as trivial the very real threats to women’s mental and physical health inherent in abortion procedures. In documents filed as part of Indiana’s Nov. 8 motion for summary judgment, multiple women’s testimonies are included to help shed light on the experience of obtaining abortions.

One woman, speaking of an abortion induced by medication in which the patient expelled the deceased fetus at home, said: “The thing I remember most is when I passed the baby. . . . I sat on the bathroom floor and cried. Then I had to flush my baby down the toilet because that was what the clinic had told me to do.”

A meta-analysis of research cited in Indiana’s motion showed that women with a history of abortion experienced an 81% increased risk for various mental health problems compared with women who had not had an abortion. It also documented a 55% increased risk of mental health problems associated with abortion compared with women who took an unplanned pregnancy to term.

Besides mental-health concerns, women face significant threats to their physical health. Surgical abortion features such risks as “bleeding, infection, or injury to the cervix, vagina, or uterus,” as described in one physician’s testimony. Medication-induced abortions also carry risks to women’s physical health, with many women experiencing far worse pain and bleeding than expected. “There was so much pain and blood that I thought I might die,” one woman testified.

Indiana’s motion for summary judgment also highlights the importance of licensed physicians for all abortions; the need for abortion physicians to have hospital admitting privileges; the need for physicians to report abortions; the importance of hospitals and ambulatory surgery centers for late-term abortions; and abortion clinic licensing. Further, Indiana’s motion delves into appropriate content and procedures of informed consent, covering such topics as Indiana’s abortion brochure; required disclosure of information; the 18-hour waiting period; the fetal ultrasound; and in-person counseling.

Beyond WWHA’s disregard for the clear need for measures to protect the health and safety of women, Attorney General Hill said, the challenge brought by WWHA is simply based on a faulty legal premise.

“Plaintiffs’ claims fail as a matter of law,” Attorney General Hill said. “Their broad theory is that, under Whole Woman’s Health v. Hellerstedt, the benefits and burdens of all abortion restrictions are subject to judicial fact-finding and rebalancing. But as already confirmed in this very case, controlling precedents upholding abortion restrictions remain good law.”