The Environmental Protection Agency (EPA) is responsible for reviewing chemicals in commerce and those entering the marketplace. Currently there are more than 40,000 active chemical substances in commerce, with more submitted to EPA for review annually.
EPA’s Integrated Risk Information System (IRIS) database contains the agency’s scientific position on the potential human health effects that may result from exposure to various chemicals in the environment. EPA’s IRIS Program, which produces toxicity assessments, has been criticized in the past for timeliness and transparency issues. In response, the IRIS Program committed to making program improvements starting in 2011, which the National Academy of Sciences (NAS) recently commended.
The Toxic Substances Control Act of 1976 (TSCA) as amended in 2016 provides EPA with additional authority to review both existing and new chemicals and to regulate those that EPA determines pose unreasonable risks to human health or the environment.
The EPA has faced criticism for delaying work on chemicals like formaldehyde, which is listed as a probable human carcinogen, and a Government Accountability Office (GAO) report now confirms EPA leadership delayed assessments of toxic chemicals for months in 2018 and ultimately slashed the number of chemicals being assessed after saying they weren’t a priority.
The March 4 GAO report describes the extent to which the IRIS Program has addressed identified challenges and made progress toward producing chemical assessments; and the extent to which EPA has demonstrated progress implementing TSCA. GAO reviewed NAS and EPA documents and interviewed officials from EPA and representatives from two environmental and two industry stakeholder organizations.
On the positive side, GAO says IRIS, which prepares human health toxicity assessments of chemicals, has made progress addressing historical timeliness and transparency challenges in the assessment process. Efforts to address timeliness include employing project management principles and specialized software to better plan assessments and utilize staff. In addition, to address the need for greater transparency in how the program conducts assessments, IRIS officials and the IRIS Program have implemented systematic review, which provides a structured and transparent process for identifying relevant studies, reviewing their methodological strengths and weaknesses, and integrating these studies as part of a weight of evidence analysis.
The GAO investigation found that since the process improvements were implemented, the program made progress toward producing chemical assessments through May 2018. In June 2018, the EPA Administrator’s office told IRIS officials that they could not release any IRIS-associated documentation without a formal request from EPA program office leadership. In August 2018, according to IRIS officials, program office leadership was asked to reconfirm which ongoing chemical assessments their offices needed. In late October 2018, these offices were asked to limit their chemical requests further, to the top three or four assessments. At the same time—4 months after IRIS assessments were stopped from being released—28 of approximately 30 IRIS staff were directed to support implementation of TSCA, as amended, with 25 to 50 percent of their time, according to officials. Then on December 19, 2018, the Office of Research and Development released its IRIS Program Outlook, which provided an updated list of 13 assessments. Eleven of the 13 chemicals on the IRIS Program Outlook were requested by two EPA program offices. A memorandum issued earlier in December, gave no indication of when additional assessments could be requested or what the IRIS Program’s workflow would be in the near term.
The delays have also had a negative impact on industry. Representatives GAO interviewed from industry stakeholder organizations said that delays motivate companies to introduce chemicals first in foreign markets. For example, one company said it developed a new technology in the United States, but because of the lengthy delays experienced with new chemicals reviewed under TSCA, they will neither register nor commercialize the product in the United States at this time. Rather, the company has decided to pursue commercialization in Europe, which will enable the company to deliver the benefits of this new technology to their customers in the European market sooner than is possible in the United States.
GAO found that EPA has demonstrated progress implementing TSCA, which was amended in June 2016, by responding to statutory deadlines. For example, EPA finalized rules detailing the general processes for prioritizing and evaluating chemicals, known as the Framework Rules, but three of the four rules have been challenged in court. Environmental organizations have argued, among other things, that TSCA requires EPA to consider all conditions of use in prioritizing and evaluating chemicals, rather than excluding, for example, uses that EPA believes are “legacy uses,” for which a chemical is no longer marketed. EPA argued that TSCA grants it discretion to determine what constitutes a chemical’s conditions of use. Amendments to TSCA in 2016 increased EPA’s responsibility for regulating chemicals and in turn, its workload. As such, EPA is required to prioritize and evaluate existing chemicals by various deadlines over an extended period and to make a regulatory determination on all new chemicals. Senior management told GAO that they were confident that ongoing hiring and reorganization would better position the office that implements TSCA.
IRIS officials told GAO that proposed budget cuts have caused them concern about whether they will have sufficient resources to expand assessment work in the future. The human health risk assessment area, of which IRIS’s budget makes up approximately half, has been funded at about $38 million annually since fiscal year 2013. However, the President’s budget request for human health risk assessment work in fiscal years 2018 and 2019 was $22.5 million and $22.2 million, respectively. This represents a cut of approximately $17 million from previous budget levels dating back to fiscal year 2013. The IRIS Program budget would drop approximately 40 percent from $20.8 million to approximately $12 million if these cuts were enacted. Congress did not support these reductions. Specifically, according to the joint explanatory statements accompanying the Consolidated Appropriations Act, 2018, and Consolidated Appropriations Act, 2019, Congress had agreed to continue providing funding at fiscal year 2017 enacted levels.
Cuts to the program could impact EPA’s regulatory work. Officials in almost all of the program and regional offices that use IRIS assessments told the GAO investigation that they rely on IRIS assessments to do their work—it is the first place they look for chemical toxicity values, and if the IRIS Program is unable to produce assessments, their offices would be challenged to meet statutory deadlines and there would be a generally negative effect on public health.
In its official response, EPA said it met every requirement and the program has improved enough to no longer be considered “high risk” by GAO.
In addition to addressing GAO’s concerns, EPA is under attack from Democrats who are calling for the agency to finish its delayed research on formaldehyde, and for ethics officials to investigate a political appointee who agreed to recuse himself from working on health assessments for formaldehyde, and who Democrats say had a role in the agency’s decision to stop work.