EPA’s chemicals office is struggling, and industry needs to stop withholding critical data on substances under risk assessment, the division’s head told a business group Wednesday.
“I have had more than one company tell me to my face they don’t want to tell the agency their information,” said Michal Freedhoff, the assistant administrator for the Office of Chemical Safety and Pollution Prevention, at a chemistry solutions summit held by the U.S. Chamber of Commerce.
Over the past few months, the agency has published a slew of proposed rules, including its framework for handling new PFAS, changes to its new chemicals review process and harsher restrictions on “high priority” chemicals such as methylene chloride and perchloroethylene, or PCE.
All of those proposals have been met with mountains of complaints, with the American Chemistry Council and companies such as Dow Chemical Co. raising concerns that the cumulative impact will inhibit innovation, result in jobs moving offshore and hinder the Biden administration’s priorities on climate change.
“We need you guys earlier in the process … and that way, there will be certainty all around so that we’re not in this fire drill situation,” Freedhoff said. “It’s your responsibility to come in earlier.”
“We’re going to be sued,” Freedhoff continued, “But I can say with a lot of confidence that my staff and I have our processes well documented.”
Kari Mavian, global director of regulatory advocacy and policy at Dow Chemical, agreed that meeting early and often with regulators “is clearly important.”
But she also defended the company’s criticism.
“Sometimes we’re not able to develop the data until we know what their endpoints are going to be,” Mavian said later during a panel at the summit, pointing to potential new workplace limits for 1,4-dioxane, a chemical that EPA has classified as a likely human carcinogen. “So we need to work with the agency, too, on getting things earlier and often.”
EPA’s chemicals office has been “playing catch-up,” Freedhoff said, to overcome its troubles dating from even before Congress passed major amendments to the Toxic Substances Control Act in 2016. Those changes require the office “to do five times the work” as before with fewer staff members and the same budget, Freedhoff said.
“All three administrations — Obama, Trump and Biden — have all struggled the same way,” Freedhoff said. “We’ve struggled with the balance, and we’ve struggled with the deadlines.”
A Government Accountability Office report released earlier this year confirmed that EPA’s chemicals office has missed more than 90 percent of the TSCA-mandated 90-day deadlines for new chemical reviews.
Industry and environmental groups have pointed at EPA’s shortcomings. The American Chemistry Council has been tracking the hundreds of new chemicals that are not allowed to enter the market until EPA makes its risk determination. On Monday, advocacy groups sued EPA over missed deadlines, requesting a new timeline for 22 “high priority” substance reviews.
Those delays have monumental effects on the automobile industry, said Mark Bacchus, a senior engineer with Toyota Motor North America Inc.
“We’re working on electrifying our fleets … but in order to do that, we’ve got to get chemicals approved by the agency,” Bacchus said at the summit. “We’re just twiddling our thumbs and thinking, when do I make the call to my executives to say, ‘Sorry, you gotta delay SOP [start of production] because we’re waiting for that chemical to be approved at the agency’?”
Health and environmental advocates have argued that EPA should take the time necessary to ensure harmful chemicals don’t enter the market before proper review — which was the case for 80 percent of chemicals before 2016, the agency has said.
Freedhoff acknowledged industry groups’ concerns and said, “We absolutely have more work we need to do.” But she said she is hopeful that new proposals — including additional data reporting requirements announced in May — will help counteract some of the complaints.
“We’re not where we need to be,” Freedhoff said. “We absolutely have more work we need to do.”
Freedhoff also hinted that EPA has whittled down its list of which existing chemicals may be deemed “high priority” and subject to a thorough risk evaluation and determination process, a procedure mandated under TSCA. That list is down to 10 to 15 substances under consideration, she said. In December, the agency will announce the final five chemicals.
Correction: An earlier version of this story incorrectly explained an acronym used by Mark Bacchus.