This content is sponsored by the American Chemistry Council.
While the Environmental Protection Agency (EPA) plays a key role in assessing the safety of chemicals used in various products, the agency’s effectiveness has been hindered by its inability to meet statutory deadlines and manage its resources efficiently, resulting in a burgeoning backlog of new chemicals awaiting review.
Under the Toxic Substances Control Act (TSCA), the EPA is required to determine the safety of new chemicals before they can be manufactured in or imported into the United States, and the agency must complete those safety reviews within 90 days of a manufacturer or importer submitting an application.
Unfortunately, the EPA almost always misses its statutorily mandated deadlines.
“Imagine America’s role as the most innovative country in the world being at the mercy of a bureaucratic backlog at EPA and then think about how China will happily fill that void,” said Chris Jahn, president and CEO of the American Chemistry Council (ACC), which represents more than 190 companies engaged in the business of chemistry. “If EPA can’t keep pace with Americans going to work every day to drive progress through chemistry, then businesses will be forced to take their products and people elsewhere. It’s happening in Europe already, but we cannot let it happen here in the United States.”
Chemistry is the starting point of every supply chain. Chemistry is key to American innovation and critical to the manufacturing of advanced products such as semiconductors, electric vehicles, battery storage, lifesaving medical devices, materials designed to make buildings more energy efficient, and more.
“Now is the time for renewed focus and action,” Jahn said. “ACC and America’s chemical industry urge Congress to ensure the EPA is prioritizing its resources, focusing on its statutory mandates and effectively implementing the TSCA program.”
Research shows that Americans are paying attention.
At least two-thirds of adults both nationally and across battleground states believe that the chemical sector is essential to the Biden administration’s priorities, according to a recent ACC survey.
“Americans agree with us that chemistry is essential. However, in the nearly eight years since Congress overwhelmingly passed and President Obama signed into law significant legislative reforms to TSCA, the nation’s chemical management regulations remain challenged and in need of attention,” Jahn said.
When ’90 days’ turns into five years and counting
A web tool launched by the ACC that tracks the progress of TSCA new chemical reviews found that, as of Feb. 9, 379 new chemicals were undergoing TSCA review, and 94% of them (357) were beyond the 90-day statutory deadline.
“The lack of timeliness and uncertainty in TSCA new chemical reviews have an adverse effect across the supply chain and economy,” said Kimberly Wise White, Ph.D., ACC’s vice president for regulatory and scientific affairs.
In some cases, it takes the EPA years to complete a review.
As a result, more than 70% of ACC members are considering bringing new chemistries to market outside the U.S.
“We are currently witnessing this effect on new investments and innovations, resulting in many chemical producers choosing to manufacture and introduce their new chemistries offshore,” said White.
Such chemistries create new products and improve existing ones that can help solve global sustainability, climate, clean energy and infrastructure challenges.
For example, one ACC member reported waiting five years for approval of a new chemical that will be used in electric vehicle batteries.
Another ACC member was informed by the EPA that two of its products under review would take an additional year to complete, despite already being six months into the review process.
“This coupled with the EPA’s approach and timeliness for the risk evaluations of existing chemicals already in commerce could dramatically impact the economy and the marketplace,” White explained, noting that the EPA often does not assess real-world exposure scenarios or conditions of use when making TSCA safety determinations on existing chemicals.
What should Congress do?
The EPA’s problems have been getting the attention of lawmakers from both sides on Capitol Hill.
In January, the Senate Environment and Public Works Committee took a closer look at TSCA chemical reviews, hearing testimony directly from Dr. Michal Freedhoff, the EPA’s assistant administrator in charge of the chemical safety office.
Freedhoff made numerous commitments, agreeing to be more transparent in how the EPA uses data submitted by chemical manufacturers in its decision-making.
“We know that our stakeholders on all sides are frustrated,” Freedhoff said. “We have a responsibility to do better.”
ACC appreciates these commitments and agrees that more work is needed to ensure that innovative new chemistries – which require years of investments, research and development to create – are not needlessly held up in the review process.
“We recognize there are continuing concerns that we are not moving fast enough, and I know there is more we can improve upon,” Freedhoff said. “I believe we can and must do more.”
In response to Freedhoff’s comments, the ACC commended EPA for the actions underway but continued to encourage Congress to ensure that the agency is managing TSCA properly and making progress to meet its goals.
“What we didn’t hear from Dr. Freedhoff was a concrete plan to turn these promises into actions,” said Jahn. “It’s time for the EPA to deliver on its TSCA promises.”
The ACC said that the ongoing and growing backlog of new chemicals in the review process had climbed to “unacceptable levels.”
“We are calling on Congress and the EPA to work with industry and stakeholders to ensure TSCA is being effectively implemented,” said Ryan Jackson, vice president of federal affairs at ACC. “We want to support innovation, smart regulation, and ensure the chemical industry is able to fully contribute to new U.S. manufacturing.”
