A group of eastern North Carolina public health and environmental organizations is calling on the U.S. Environmental Protection Agency’s new leadership to overturn the former administration’s denial of a petition asking the agency to require Chemours to fund testing on more than 50 chemicals produced at its Fayetteville plant.
During the days since those organizations resubmitted their petition and concurrently filed a lawsuit challenging the denial earlier this month, changes have already been made to the EPA’s per- and polyfluoroalkyl substances, or PFAS, action plan rolled out under the Trump administration, with more likely to come as the plan is reviewed by the current administration.
Since President Biden took office in January and, as is typically the case with any new administration, the EPA has been undergoing a transition period, including the March 11 swearing-in of the agency’s 16th administrator, Michael Regan, formerly the North Carolina Department of Environmental Quality secretary.
“He’s hit the ground running, and I can say that in all the remarks that I’ve heard him make thus far that PFAS is certainly one of his top priorities, so I will say off the bat I anticipate our action plan will continue to get refined as he gets up to speed,” said Aaryn Jones, EPA interim Region 4 (Southeast) PFAS coordinator.
What that means for the organizations asking the current administration to reverse the denial of their petition remains to be seen.
What is clear at this point is that the organizations and the EPA agree that more research needs to be done to determine how these chemicals affect human health and the environment.
The debate the petition brings forth is the methods in which that research is conducted and who should cover the cost of the studies.
By the numbers, a small request
PFAS are a group of about 5,000 synthetic compounds used to make water- and grease-resistant products found in nonstick cookware, firefighting foam, water-repellent clothing, lubricants, stain-resistant carpets, paints, cosmetics and fast-food packing.
Last summer, Chemours, as part of its consent order agreement with North Carolina, showed that its Fayetteville Works Facility was releasing more than 250 unknown compounds into the Cape Fear River.
Drake Phelps is a scientific adviser to the group of petitioners, which include the Center for Environmental Health, Cape Fear River Watch, Clean Cape Fear, North Carolina Black Alliance, Democracy Green and Toxic Free NC.
“These are compounds that Chemours themselves doesn’t appear to know what they are, and this is for a variety of reasons,” said Phelps, a doctoral candidate at North Carolina State University studying how PFAS suppress the immune systems in fish and humans and a member of Clean Cape Fear. “It may be technical issues identifying them. It could be that they are very complex structurally or chemically complex. It just goes to show that this is an immense problem that our petition is a subset of 54 (PFAS), but really, this is huge.”
The petition originally submitted last October asks the EPA by authority under the Toxic Substances Control Act, or TSCA, to order Chemours to fund testing by independent scientists on 54 PFAS manufactured at the Fayetteville plant and have been found in human blood, drinking water, groundwater, soil, air and crops grown adjacent to and downstream of the plant.
PFAS have been released into the Cape Fear River, a water source for nearly 300,000 residents, for decades, a fact brought to the public’s attention in 2017 in an article published by the Wilmington Star-News.
In a multitude of public meetings held in and around the region since that article broke, one recurring question from residents has been “What do these chemicals do to our bodies?”
Take, for example, GenX, the commonly used term for perfluoro-2-propoxypropanoic acid, a chemical compound produced to make Teflon, which is used to make nonstick coating surfaces for cookware.
Last year, a study of GenX’s effects in pregnant mice and their offspring conducted by a research team at the University of North Carolina Chapel Hill showed the compound caused gestational weight gain and maternal liver damage.
The study, the results of which were shared in August with the North Carolina Secretaries’ Science Advisory Board, compared the toxicity of perfluorooctanoic acid, or PFOA and GenX in pregnant mice and their developing placenta and embryos. Both PFOA and GenX had adverse effects, including abnormal lesions in mature placenta.
“To know it’s toxic in a lab setting yet not understanding what that toxicity relates to in public health, it’s troubling,” said Emily Donovan, co-founder of Clean Cape Fear. “I can empathize with the medical community because you can treat or test or look for anything, but that doesn’t mean it’s going to be relevant to what you’re exposed to without the foundational information. There’s a severe data gap.”
The North Carolina Department of Health and Human Services has established a health goal of 140 parts per trillion for GenX. There are no federal guidelines for the chemical compound.
“I think it’s important to point out this is a very modest request and it’s funny because it is not being seen as a modest request,” Donovan said. “We know that Chemours released over 250 PFAS into the river. So, to ask for toxicity data for 54 is actually a very modest request and when we stop to look at that 300,000 (people) view and look at it at that scale, we realize this is a very modest request for a big problem.”
Chemours did not respond to a request for comment for this report.
PFAS Action Plan – a work in progress
In its Jan. 7 denial, the Trump administration said the petitioners failed to prove there is insufficient data for each of the 54 PFAS.
In their early March request to then-acting Administrator Jane Nishida, the petitioners argue that it is the responsibility of the EPA to decide how much information is available on the 54 PFAS and whether health assessments of exposure of those chemical compounds should be researched.
The group on March 3 also filed a lawsuit in the Northern District of California challenging the denial of their petition.
That petition breaks down the 54 PFAS into two tiers.
Chemicals in Tier 1 are the compounds that have been found in human blood samples taken from residents in the Cape Fear region and therefore need to be studied in detail, Phelps explained.
Compounds listed under Tier 1 require less testing because they have not been found in drinking water or human blood samples, but they have been found in the environment.
The EPA released a letter explaining its decision to deny the petition, stating in part “The denial is not based on lack of concern with PFAS.”
The letter referred to the agency’s February 2019-issued PFAS Action Plan, which identifies 23 actions the agency will undertake in identifying and understanding PFAS, ways to address current PFAS contamination and prevent future contamination and educate the public about PFAS.
The plan was updated in February 2020.
The U.S. Government Accountability Office conducted from December 2019 until January of this year a performance audit of the plan. The audit, published March 1, determined that the EPA has completed three of six selected regulatory-related actions outlined in the plan.
Two of the actions completed were in response to the National Defense Authorization Act, or NDAA, for fiscal year 2020, including a final rule that certain PFAS created as a surface coating and carpet containing certain PFAS cannot be imported into the country without being reviewed by the EPA.
The 2020 NDAA also directed the EPA to include 172 PFAS into the Toxics Release Inventory.
In March 2020, the EPA took the initial step to regulate two PFAS in drinking water, an action that was not required under the NDAA.
The EPA responded to the Government Accountability Office audit, urging that the regulatory actions reviewed should be placed in a broader context of the overall plan.
The agency “expressed concern that separating scientific work from our discussion of regulatory-related actions could create misunderstandings within Congress, among the states, and the American public about what is required under statutory requirements from a science and research perspective,” according to the report.
The agency also pointed out the steps it has taken to compile and assess human and ecological toxicity information on PFAS.
Since the completion of the Government Accountability Office’s report, the EPA under the current administration has taken action and reissued action relating to the plan, Jones said.
One of the first actions by the new administration was removing a toxicity assessment for perfluorobutane sulfonic acid, or PFBS, a common PFAS used to replace perflurooctane sulfonate, or PFOS.
“So, it’s a toxicity assessment that was long awaited,” Jones said. “It was issued the 19th of January and it was removed from our website on February 9 to undergo further review under the agency’s scientific integrity policy. We’re just reaffirming our commitment to making evidence-based decisions as developing policies and programs that are guided by the best available scientific data. So truly, this is one of our our first actions under this administration. And, again, a strong, strong foundation in science is where we want to be going forward. That review is ongoing.”
— Aaryn Jones, Environmental Protection Agency
— Aaryn Jones, Environmental Protection Agency
The agency has also reissued three water-related items for PFAS and, on March 3, published its final regulatory determination for PFOA and PFOS.
“This regulatory determination that we finalized outlines avenues that the agency consider to further evaluate additional PFAS chemicals beyond just PFOA and PFOS and would also provide the flexibility for the agency to consider groups of PFAS as supported by the available science,” Jones said. “It sets in motion how we would develop a regulation for drinking water for those two chemicals and that could still take some time so we’ll be working on developing those drinking water regulations and will publish a proposal for public comment by March 2023. As part of that process to develop the proposed rules for those we would seek input from EPA Science Advisory Board, the National Drinking Water Advisory Council and other stakeholders as we develop that proposed rule.”
Once that proposed rule rolls out, final action will be taken within 18 months.
The agency also reproposed and published the fifth Unregulated Contaminant Monitoring Rule, or UCMR 5. The proposed rule would require sample of 29 PFAS, including GenX, to be collected between 2023 and 2025, the research of which “would provide new data that is critically needed to improve EPA’s understanding of the frequency that 29 PFAS are found in the nation’s drinking water systems and at what levels,” according to the EPA.
Public comments on the proposed UCMR 5 will be accepted through May 10.
The new administration has also taken the step of soliciting data on the presence and treatment of PFAS in wastewater discharges from PFAS formulators and manufacturers.
“This is particularly relevant to the eastern North Carolina issues with Cape Fear and Chemours being along the river there,” Jones said. “This action is under the Clean Water Act and EPA would be evaluating if the wastewater discharges from industrial sources of PFAS warrant a regulation through the national effluent limitation guidelines.”
The public comment period for that proposed action ends May 17.
“We have several things that are still open for comment and then we have the drinking water regulation process that has now been set forward, but it can be a lengthy process and could take a number of years to develop as regulation,” Jones said.
Decisions made at the federal level directly affect the oversight of the chemicals at the state level.
“Multiple states including North Carolina have been asking for enforceable federal limits to aid efforts to address PFAS compounds in the environment,” Anna Gurney, public information officer for the North Carolina Division of Water Resources, said in an email.
“When a federal agency, like EPA, undertakes the research review and scientific analysis to set a standard such as a drinking water maximum contaminant level, or MCL, the resources in states are preserved for other activities such as monitoring and testing. If each state has to undertake the establishment of standards, health goals, etc., many resources are used in multiple states,” Gurney said. “If a federal agency handles the task of setting a standard or health advisory level, then the resources of the federal government are used once, versus multiple states undertaking the question of a health level for a given compound. The EPA can help with establishing lab test standards as well, so that all the states and private labs across the country are analyzing for PFAS compounds consistently and the results can be compared without many caveats as to how a given sample was analyzed.”
Understanding the effects PFAS has in humans and the environment may also take years.
“It’s a process and it’s one of those things that we see it as a useful time investment and a money investment because we’re talking about people’s health,” Phelps said. “We’re talking about our children being exposed. We’re talking about our pets being exposed, our parents, the innocent animals and the environment that rely on the Cape Fear River so that’s why it’s necessary to perform these tests because we’re talking about the health of so many living organisms in this state. Every year we don’t act we are spending more and more money in medical costs and in costs to clean (PFAS) up rather than we are to act on these chemicals.”
In its denial of the petition, the EPA stated it is in the process of testing five of the compounds included in Tier 1 list of the 54 PFAS the petitioners want Chemours to pay independent scientists to study.
Phelps calls the EPA’s testing method of those PFAS “insufficient” because the compounds are being tested in vitro, meaning tests are conducted on a plate of cells.
He argues the best testing method to determine the effects of PFAS in mammals is through in vivo, work done with an entire living organism.
“When we think about the general public drinking these harmful compounds in their water, they’re an intact, full organism essentially where you have a heart that’s beating to pump the chemical around in your body,” Phelps said. “You have a liver that is responding to this new chemical in your body. You have kidneys that are working to try to eliminate it.”
Jones said a number of exposure experiments are being conducted at the EPA’s campus in Research Triangle Park. She did not have details of those ongoing experiments.
The debate on the best method with which to study health effects of PFAS in humans does not eclipse the sheer number of PFAS that exists.
“There are by EPA’s own count now probably more than 9,000 different PFAS,” Phelps said.
“Really the snowball is already coming down the hill on this. We can’t nickel-and-dime this when we go just one chemical at a time because there’s not enough time and not enough resources to go that route. We’re saying that all PFAS are bad and we need to address them as a chemical class. This has been done for other chemical classes in the past … so it’s not unheard of to treat chemicals as a class, but it’s complicated when you don’t have certain data and that’s what EPA comes back to when EPA says we need to have data on hand to support this class approach,” Phelps said. “Right now, the American taxpayer is paying for those invitro tests to be performed by the EPA. But EPA has the power under the 2016 amendments to the Toxic Substances Control Act to request that industry perform and pay for these tests that the EPA requests and that is the authority under which we filed this petition. It’s a big issue for a number of reasons and it’s time that the chemical industry foot this bill.”
Jones said she is not familiar with the petition but she reiterated the EPA’s commitment to researching PFAS.
“We’re going to continue to conduct research,” she said. “There’s going to be a heavy emphasis on studying PFAS harms to the people and the environment, how people are exposed and looking at how different technologies can be used to remove PFAS from drinking water. We’re looking to make all future decisions with that strong underpinning of science and working in partnership with our states.”
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