The American Chemistry Council (ACC) maintains that the Environmental Protection Agency (EPA) stifles innovation and puts the U.S. chemical industry at a competitive disadvantage by consistently missing its mandated 90-day deadlines to assess new chemicals.
An EPA Office of Inspector General (OIG) report released on Aug. 2 seemed to validate many of ACC’s concerns, including inconsistencies in the review process. The report also determined the agency lacks the resources to ensure its new chemicals review process under Toxic Substances Control Act (TSCA) operates as intended. The ACC and a group that represents EPA whistleblowers agree with many of the findings in the OIG report but disagree on who is responsible for the issues and the proposed solutions.
Internal complaints triggered the investigation amid allegations that the EPA was prioritizing the 90-day deadline over potential safety risks when conducting new chemical reviews. The EPA OIG found no evidence that the agency's New Chemicals Division explicitly includes TSCA’s 90-day review requirement as an employee performance standard.
For the chemical industry, the ruling offers hope that the EPA’s TSCA reviews will be more efficient and transparent, leading to faster approvals. The OIG’s 29-page report outlined several failings by the agency, including a shortfall of staff to conduct new chemicals reviews within its required timeframes and lack of standard operating procedures (SOPs) for key activities.
“SOPs and QA/QC (quality assurance/quality control) procedures help ensure that all assessments use the best available science and use a weight of evidence,” says Lynn Bergeson, managing partner with Bergeson and Campbell, P.C. and a Chemical Processing regulatory columnist.
The EPA accepted the recommendations from the internal investigation, which includes plans to regularly review and finalize guidance documents for reviews, develop an assessment process to ensure the official TSCA recordkeeping system is updated, identify root causes for ongoing technical issues and conduct period reviews of its TSCA review workforce and regularly balance the workload with adequate staffing.
While Bergeson was encouraged by the EPA’s acceptance of the OIG’s recommendations, she says much work remains to ensure innovation is not denied by misapplications and misinterpretations of TSCA. The EPA, she said, continues to interpret 2016 amendments to the Toxic Substances Control Act “in demonstrably incorrect ways.”
“OIG correctly identified problems and suggested good solutions, but serious problems will persist,” Bergeson noted in a draft of a column she wrote and shared with CP.
“There is more wrong with the new chemicals review process than the audit revealed,” Bergeson wrote.
Bergeson suggested that the EPA seek stakeholder comment to address problems in the new chemical review process, adding that the current process is leading to fewer new-chemical submissions.
More Reports Coming
The Public Employees for Environmental Responsibility, or PEER, is an organization that supports whistleblowers who have worked for government agencies. The nonprofit has filed complaints in the past on behalf of EPA scientists who alleged the agency’s managers often overlook or omit the risks of new chemicals in their reports.
PEER did not file the complaints that led to the Aug. 2 report EPA OIG report. But the organization expects reports based on its clients’ allegations to be completed soon, likely in the fall, says Kyla Bennett, director of science policy for PEER. The advocacy group contends that EPA managers and senior staff are altering risk assessments to get chemicals on the market.
But Kimberly Wise White, vice president of ACC’s regulatory and scientific affairs division, notes that gaining approval on new chemicals has become a time-consuming process. In a July 5 CP editorial, she said 91% of new chemical reviews are backlogged in the EPA’s evaluation process. As of Aug. 15, the EPA had met its required deadlines on 28 out of 399 new chemicals in TSCA review, according to ACC’s new chemicals reviews tracking tool.
PEER’s Bennett blasted the ACC’s contention that the EPA’s new chemicals reviews are innovation killers.
“There are only 36 scientists to handle all the thousands of requests that come in, and there is a 90-day statutory deadline, which they cannot meet because of resource constraints and because the chemical industry doesn’t provide them with good information,” Bennett says. “On some of these risk assessments, these scientists get the name of chemical and an abstract of one industry study, and they have 90 days to determine whether this new chemical is going to create an unreasonable risk to human health and the environment.”
Bennett adds that although the EPA has the authority to require testing and more information from the chemical industry, the agency rarely asks for it. In an email response to Bennett’s comments, ACC referenced Wise White’s July 5 column in which she stated that the current review process could force manufacturers to develop new chemistries outside the U.S.
“It is time for the EPA to take action and develop a comprehensive plan to improve the pace of new chemical reviews,” ACC stated. “ACC and its members will continue to engage EPA and offer to improve the New Chemicals Program and advocate in support of policy remedies that will strengthen and protect U.S. innovation and manufacturing.”
What Can Chemical Processing Companies Do?
Navigating TSCA can be particularly confusing for companies that are new to the review process, says Marshall Morales, an attorney and senior managing associate who specializes in environmental law for Sidley Austin LLP.
“In recent years, many emerging companies, or established companies expanding into new industries, have found the often-delayed new chemicals review process challenging to their business goals—we’ve observed this especially in areas of batteries, biofuels and semiconductors,” he says. “Each of those sectors is growing substantially and has recently robust support from the federal legislative or executive branches, but in some cases rapid growth can outpace regulatory planning or realistic submission timelines.”
Morales recommends that manufacturers impacted by TSCA first invest in strategic, multiyear regulatory planning for their regulated processes and products, while recognizing realistic timelines for agency approvals. Companies also should ensure they make detailed and complete submissions to the EPA and anticipate any technical questions or gaps the agency might raise.
Morales adds that companies should engage with the EPA staff early in the process to understand how the agency will consider a particular submission and to avoid unforeseen delays.
