In the recent ProPublica article, “She’s Supposed to Protect Americans from Toxic Chemicals. First, She Has to Fix Trump’s Mess and Decades of Neglect,” Dr. Michal Freedhoff, PhD, EPA’s head of the Office of Chemical Safety and Pollution Prevention (OCSPP) said:
“You can’t ask companies to spend a bunch of money producing data that already exists.”
Unless, of course, the data do not already exist.
Freedhoff was referring to a citizens’ petition for EPA to order the Chemours Company to conduct studies of PFAS chemicals that have contaminated communities in the Cape Fear River watershed, which provides drinking water to over a quarter of a million people in North Carolina. The article explains, “Freedhoff said she’d pushed as far as she legally could… the agency had to prove the current data was insufficient before ordering new tests.”
Dr. Freedhoff’s quote (and the related text) implies that data sufficient to assess risks are already available for the 54 PFAS chemicals included in the petition. This is not supported by EPA’s own response to the petition, which says:
- None of the 54 petition chemicals are among the few types of PFAS that EPA considers “data rich.”
- 39 petition chemicals are in “data poor” categories of PFAS (yet EPA will issue test orders for only 7 of these 39).
- EPA excludes the remaining 15 petition chemicals from consideration with an explanation that they “do not meet the definition of ‘PFAS’ for purposes of the Testing Strategy; therefore, the Agency has decided it is not appropriate to require the development of information about these substances at this time.” (EPA relies on a highly disputed technical definition of PFAS, instead of responding to community concerns about their exposure to these 15 chemicals. This disputed definition does not preclude EPA from issuing test orders.)
- EPA identifies four petition chemicals out of the excluded 15 as having “relatively robust toxicity information available.” (EPA provides no references or other supporting details for these four and states the remaining 11 will not be considered for testing despite not having adequate information.)
EPA’s response to the petition never stated that sufficient data for the 54 PFAS were available, as Dr. Freedhoff suggests. In fact, Ruthann Rudel and her colleagues at Silent Spring Institute submitted a literature review to EPA which showed that the 54 PFAS lack most or all of the studies proposed in the petition. This literature search did what Dr. Freedhoff said EPA could not do – “prove the current data was insufficient.“
EPA’s response stated that “EPA has determined that the petition sets forth facts demonstrating that it is appropriate to issue a section 4 order to address the health and environmental effects of PFAS.” In other words, EPA recognizes that sufficient information on the 54 PFAS are not available. The baffling aspect of EPA’s response was that, despite finding that the petitioners met their burden to justify testing under TSCA, EPA still failed to require testing on nearly all the 54 PFAS. Neither Dr. Freedhoff nor the petition response explains why the Agency said it was “granting” the petition but then did not order the testing sought by petitioners.
One of the motivations for amending the Toxic Substances Control Act (TSCA) in 2016 was a need to make it easier for EPA to obtain necessary health data on chemicals that are already in use and to which we are exposed. Amended TSCA, which Dr. Freedhoff helped to write as a senior congressional staffer, expanded EPA’s authority to require chemical manufacturers to conduct testing to inform the assessment of their products’ hazards and risks. Unfortunately, Dr. Freedhoff’s statement regarding EPA’s PFAS petition response does not adequately explain the Agency’s reluctance to make full use of its authority for the PFAS chemicals or for the chemicals currently subject to risk evaluation under TSCA. Failing to do so leaves the public at greater risk from harmful chemicals.
Prior to Dr. Freedhoff’s tenure, EPA issued test orders on only one of the first 10 existing chemicals evaluated under TSCA (which were prioritized for potential harm), despite numerous holes in the data of these chemicals. EPA has issued additional test orders for some of the high-priority chemicals it is now evaluating but they are limited in scope and do not include the major health effects studies needed for informed assessment of hazard and risk. This failure is disturbing for many reasons, one of which is because EPA makes assumptions that a lack of data equates with a lack of risk. This is a particular concern for PFAS, where the properties of the class point to serious health concerns even though actual data are unavailable for the great majority of PFAS chemicals.
We urge EPA to prioritize its mission of protecting health and the environment by making full use of its authority to obtain the data necessary to inform exposed communities and to properly assess hazard and risk of all the PFAS chemicals. Requiring the studies proposed in the petition would be a good first step.
About the authors
Daniel Axelrad worked at the U.S. Environmental Protection Agency for 33 years in the Office of Pollution Prevention and Toxics (1987-1993) and the Office of Policy (1993-2020).
Bob Sussman, formerly EPA Deputy Administrator and Senior Policy Counsel to the Administrator, represents the petitioners, six community groups in North Carolina, and is a leading TSCA expert.
Tracey J. Woodruff, PhD, MPH, is a former EPA senior scientist, chemical policy and research expert, and professor and director of the UCSF Program on Reproductive Health and the Environment and co-director of the Environmental Research and Translation in Health (EaRTH) Center.
