An Environmental Protection Agency Office of Inspector General (OIG) report on Wednesday determined the EPA lacks the resources to ensure its new-chemical review process under the Toxic Substances Control Act, or TSCA, operates as intended.
The OIG’s 29-page report outlined several failings by the agency, including a shortfall of staff to conduct new-chemical reviews within its required timeframes. The EPA backlog of reviews has been an ongoing point of contention with the American Chemistry Council, a trade group that represents more than 190 chemical companies.
Under TSCA, the EPA has a 90-day deadline to complete new-chemical reviews. But Kimberly Wise White, ACC’s vice president for regulatory and science affairs wrote in a July Chemical Processing column that the EPA’s new-chemical reviews take up to one year or longer to complete. She also noted that a February Government Accountability Office report determined the EPA has missed 90% of its deadlines over a five-year period.
“A well-functioning, reliable and efficient new-chemicals program is critical for TSCA’s overall success," said Wise White, in a written statement following the release of the OIG report. “ACC continues to call on EPA to develop a transparent and comprehensive path forward with measurable metrics and goals to achieve TSCA’s statutory requirements.”
The OIG report also concluded that the EPA has not complied with recordkeeping and quality-assurance requirements and has failed to finalize guidance on program activities, such as standard operating procedures (SOPs) for recordkeeping and exposure/hazard assessments. The EPA’s own guidance for preparing standard operating procedures states that SOPs are essential parts of a successful quality system, according to the report.
Also, the EPA’s New Chemicals Division (NCD) didn’t track edits to records from its review process, which affected transparency, the OIG report noted. The NCD also used multiple, disparate recordkeeping applications, which were frequently inaccessible.
“These deficiencies existed because the NCD lacked sufficient staff resources to conduct reviews within the statutory time frames, as well as to develop and finalize guidance,” OIG stated in its report summary. The absence of final guidance increases the risk that the New Chemicals Program does not meet its legislative intent to prevent unreasonable risk to human health and the environment.”
OIG recommended the EPA take several actions to address the issues highlighted in the report. This includes developing, updating and finalizing guidance for the new-chemicals program, assessing and updating the NCD’s recordkeeping applications, as needed, and addressing workload issues. The EPA agreed to all four recommendations, which are resolved with corrective actions pending.
In its response to the report, the EPA stated that it has hired additional staff to conduct TSCA reviews and is in the process of hiring more. The agency acknowledged that it has made progress over the past six months, but the hiring and training process takes at least three to six months and additional training to perform program responsibilities.
The agency also remarked that funding for the new-chemicals program continues to be a challenge. Workloads within the agency have increased substantially since Congress amended TSCA with the Frank R. Lautenberg Chemical Safety Act in 2016. The agency indicated that a lack of funding from the previous administration contributed to its workload capacity issues.
“Despite this significant increase in responsibility, appropriations for EPA’s TSCA program were flat for the first six-and-a-half years of the new law, in no small part because the previous administration did not once request any additional funding from Congress,” the agency wrote.
OIG launched the investigation after receiving complaints to its hotline that alleged NCD staff faced pressure to prioritize deadlines over the potential risks of substances when conducting new-chemical reviews. OIG found no evidence that the NCD explicitly includes the Toxic Substances Control Act statutory 90-day review requirement as an employee performance standard.
