Deal would require toxicity studies for 5 chemicals released at NC plant

Studies into the potential toxicity of five additional fluorochemicals that Fayetteville-area chemical maker has been releasing could result in additional state health advisories, similar to the one in place for the same company’s release of GenX, according to a scientist who researches such compounds.

The studies are among several requirements Chemours must meet under a proposed agreement with the state. The agreement would settle regulatory claims resulting from pollution that has contaminated the drinking water of hundreds of thousands of residents in Southeastern North Carolina.

The proposal also calls for Chemours to pay a record $12 million fine, foot $1 million of the state’s investigative costs, meet pollution abatement and remediation goals, and commit to regular monitoring and prompt disclosure.

Regulators may use information gleaned from the studies to develop regulations governing Chemours’ releases, according to the agreement. Those regulations include a permit allowing Chemours to resume discharging its manufacturing-related wastewater into the Cape Fear River. Such discharges stopped late last year.

The North Carolina Department of Environmental Quality has said it would not commit to prohibiting Chemours from discharging fluorochemicals. When questioned this month, the agency would not say whether it would await results of these studies before issuing a new discharge permit.

Anyone may comment on the proposed settlement until Dec. 21. It must be approved by a Bladen County Superior Court judge.

DEQ and the North Carolina Department of Health and Human Services are scheduled to discuss the agreement and other issues related to fluorochemicals at 6 p.m. today at Bladen Community College Auditorium in Dublin.

‘It seems like a no-brainer’

Jamie DeWitt, a professor in the Department of Pharmacology and Toxicology at East Carolina University, said the types of studies stipulated in the agreement are similar to those used by DHHS to develop its health advisory for GenX in drinking water.

The U.S. Environmental Protection Agency also used similar information to develop draft reference doses for GenX.

A reference dose — the level of daily oral exposure considered unlikely to affect a person’s health over a period of time — is an interim step from the results of toxicity studies to a standard such as the state’s GenX advisory. DHHS considers 140 parts per trillion to be the maximum concentration of GenX humans may consume in water without health risks.

“If you look at the GenX guidelines that the EPA just put out, if you look at the GenX guidelines put out by the state Department of Health and Human Services, their data came from these types of 28-day or 90-day oral toxicity studies,” DeWitt said.

“So they would hopefully get a sufficient amount of data to make a decision on whether or not they needed to generate a reference dose for these compounds,” she said. Reference doses could form the basis of health advisories should the studies point to potential problems.

“It kind of seems like a no-brainer,” DeWitt said. “If you’re making these compounds and putting them into the environment, you should be the one to conduct the tests or you should pay for the testing to be done so that those of us in the public can get a little bit of information about their potential toxicity and those in the regulatory arena have sufficient information to make a decision about whether or not these compounds should be permitted to be released into the environment.”

DHHS spokesman Cobey Culton wrote in an email that the studies “could contribute to the body of science that could be used to generate a reference dose, but may not be sufficient by themselves.”

“There is still a significant need for better health information about the PFAS mentioned in the draft consent order and other PFAS, so these studies would be a welcome addition.”

PFAS, or per- and polyfluoroalkyl substances, are a group of compounds that include the substances to be studied under the agreement.

No health monitoring for residents

The studies specified in the proposed agreement will look at some short- and longer-term effects on mice and rats.

That information may provide clues about whether the compounds pose risks to humans, but unlike with the better-known fluorochemical perfluorooctanoic acid (PFOA), also called C8, people will not be evaluated directly.

C8 contamination in the mid-Ohio Valley resulted in several regulatory and legal actions, including a class-action lawsuit filed in 2001 alleging C8 from DuPont’s Washington Works plant in Parkersburg, West Virginia, tainted water supplies of about 80,000 people in Ohio and West Virginia.

As part of a 2004 settlement, DuPont paid $70 million for a health project that included tests on more than 69,000 people. Results showed links between C8 exposure and a number of serious health problems, including testicular and kidney cancer.

DuPont created Chemours as a separate company in 2015 from business units that included the Parkersburg and Fayetteville-area plants.

Sheila Holman, DEQ assistant secretary for the environment, said last month that the animal studies are “the extent of the health study requirements. We did not include medical or health monitoring” in the proposed settlement with Chemours.

The agreement does stipulate that “DEQ reserves the right to seek additional health studies or health information beyond the scope of the initial set of studies required by this paragraph. DEQ shall consider public comments in determining what additional health studies or health information are needed.”

Verifying Chemours’ work

The studies must follow protocols from EPA and other government agencies, which include guidelines that DeWitt said “lay out the basic types of information that are acceptable to make a determination about the hazard potential of a particular chemical or other agent.”

“The guidelines do not specify that you must test for A, B and C. They lay out in general what you should collect and what is acceptable to the agency under these guidelines.

“You can do more,” she said, “but if you do less, you generally have to justify why you’re going to do less.”

DeWitt considers the studies a “step in the right direction.” Even so, she has some concerns.

The proposed agreement includes no reproductive and developmental studies, and she questioned whether the ones specified will provide sufficient detail about immune system effects.

Government protocols for the 28-day tests in the agreement include assessments for immune effects “in general,” she said. She wondered, though, if 30-day tests, with “more robust” guidelines to assess immune function, might be more appropriate.

“It seems like a very fine point, but it could be a very critical point in terms of getting appropriate information on the impact of these PFAS on the immune system,” she said.

“Until we see the work plan from Chemours, we won’t know specifically what aspect of the immune system they’re going to evaluate.”

Regardless of what happens, work is underway in DeWitt’s lab that could help verify Chemours’ results.

“I’m actually using the (more stringent) guidelines on some of these compounds,” she said. “We will have those data that will support or refute data that are generated by Chemours or whomever Chemours hires.”

Chemours must submit a plan to DEQ by Feb. 28 detailing how an independent lab will conduct studies on the five compounds to evaluate how toxic they may be to rodents and aquatic life.

How long the studies may take to complete remains unclear.

Obtaining a sufficient amount of each compound in purified form presents a particular challenge.

Brian Long, manager of Chemours’ Fayetteville Works, said in an interview last month that although he could not estimate the time required to complete the studies, “they’re going to take a fairly long time to complete.”

“These aren’t compounds that we make (commercially). They’re byproduct compounds,” Long said. “So to actually synthesize those compounds out of our (waste) streams takes time.”

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