EPA Reorganization Supports IRIS Reform

For years, industry groups have complained about the EPA’s failure to meet its deadlines for the reviews of new chemicals as required by the Toxic Substances Control Act (TSCA). Earlier this month, the Agency announced “it would disperse scientists from its independent research office to other divisions where they … will be tasked with approving the use of new chemicals,” according to The New York Times. “Administrator Lee Zeldin announced the changes to the EPA in a video, saying the agency was ‘shifting its scientific expertise’ to focus on issues he described as ‘mission essential.’”

The American Chemistry Council (ACC) released a press release in support of the EPA’s announced plans to shift resources.

Critical programs for the EPA include its Office of Chemical Safety and Pollution Prevention (OCSPP) and Office of Pesticide Programs (OPP).

“OCSPP performs essential permitting and review functions for industrial, agricultural, and specialty chemicals,” said Chris Jahn, president and CEO of the ACC, in the statement. “The functions of this EPA office advance American competitiveness, further transformative ideas, and promote new domestic manufacturing by accessing applications for new and existing chemistries. This helps ensure that new, innovative products reach American and global consumers—goals essential to this Administration.”

The permitting and review functions of the OCSPP are governed by the EPA’s Integrated Risk Information System (IRIS) Program.

What is the IRIS Program?

The EPA’s IRIS Program develops human health assessments that provide health effects information on environmental chemicals the public may be exposed to, providing a critical part of the scientific foundation for the EPA’s decisions to protect public health.

The ACC and other industry organizations have been very vocal about what they see as fundamental problems with the use of the IRIS Program.

“EPA’s IRIS program has a troubling history of being out of step with the best available science and methods, lacking transparency, and being unresponsive to peer review and stakeholder recommendations,” states an 80-coalition-member letter led by the ACC and dated January 27, 2025. “This results in IRIS assessments that jeopardize access to critical chemistries, undercut national priorities, and harm American competitiveness. The IRIS program has never been authorized by Congress, and since 2009 the program has remained on the GAO’s (Government Accountability Office’s) High-Risk List, which identifies government programs that are vulnerable to fraud, waste, abuse, or mismanagement.”

Problems with IRIS

According to this coalition, problems with the IRIS Program include:

• Its use to develop overly burdensome regulations on critical chemistries;
• Its tendency to fall short of EPA and global health agency scientific standards;
• Its failure to adequately incorporate high-quality and relevant science;
• Its inconsistent use of a “weight of the scientific evidence” approach;
• A lack of transparency in the process used to prioritize and select chemicals for assessment;
• A lack of impartiality in accurately reporting scientific information;
• Limited peer review; and
• Slow progress in producing assessments.

GAO’s recommendations

Previous GAO recommendations to improve the IRIS Program include:

1. The administrator should direct the assistant administrator of the Office of Research and Development (ORD) to provide more information publicly about where chemical assessments are in the development process, including internal and external steps in the process and changes to assessment milestones.
2. The administrator should direct the assistant administrators of program offices and regional administrators to develop and make available guidance for chemical assessment nominations. Such guidance could include information like how to select chemicals for IRIS assessment nomination or for high-priority needs, criteria explaining how assistant and regional administrators determine which nominations to support and which they may choose not to support, and how to document these decisions.
3. The administrator should direct the assistant administrator of the ORD to issue criteria for how chemical assessment nominations are selected for inclusion in the IRIS Program’s list of assessments in development and provide quality information about such topics as defining high-priority chemicals, prioritizing assessment work, and determining the IRIS Program’s capacity to undertake work.
4. The EPA’s administrator should direct the ORD to continue evaluating the survey process used to solicit IRIS user needs and assess key elements like its purpose and timing to facilitate the collection of quality information.
5. The EPA’s administrator should include in the ORD’s strategic plan (or subsidiary strategic plans) identification of the EPA’s universe of chemical assessment needs; how the IRIS Program is being resourced to meet user needs; and specific implementation steps that indicate how the IRIS will achieve the plan’s objectives, such as specific metrics to define progress in meeting user needs.

Although these GAO recommendations are now marked as complete, the program still needs work, according to the trade and manufacturing associations.

“EPA’s IRIS values fail to go through regular rulemaking checks related to notice-and-comment, interagency review, and engagement with stakeholders,” states the ACC letter. “These assessments are not valid for use in regulatory settings and often omit key information. For example, IRIS toxicity values are often set below naturally occurring background levels, detection limits, or levels of the chemical produced by the human body. Nearly all recent assessments have established toxicity values that are also well below existing standards set by EPA, OSHA, or the European Union.”

Examples of flawed assessments

Despite the perceived problems, the EPA continues to rely on flawed assessments, according to the ACC. The trade organizations included the following examples of flawed assessments in their January 27 letter:

• The recent EPA TSCA final formaldehyde risk evaluation concluded that virtually all occupational conditions of use contribute to “unreasonable risk” under TSCA because it relies on a faulty IRIS value to propose workplace limits that are significantly lower than the recently updated European Union occupational limits. This limit could result in potential bans or make it difficult to meet standards for some uses.
• EPA air rules on ethylene oxide rely on an IRIS value for ethylene oxide that is 23,000 times lower than naturally occurring levels in the human body. This flawed assessment impacts critical industries like electric vehicles, semiconductor manufacturing, and health care.
• A flawed IRIS value was used to justify an emergency Biden administration Department of Justice (DOJ) action seeking to shut down a manufacturing facility under Section 303 of the Clean Air Act (CAA).
• The IRIS toxicological review of inorganic arsenic proposes a controversial cancer risk value that’s 21 times more stringent than the current value. This value could be used to drive new regulatory levels for inorganic arsenic that are significantly lower than the background levels of arsenic in soil and water in many states, with impacts to soil remediation programs, drinking water standards, crops, and other food supplies.
• Final EPA IRIS review of hexavalent chromium disregarded the weight of evidence and may lead to a new drinking water standard far lower than the average background levels of naturally occurring hexavalent chromium in groundwater. This could impose massive costs to water systems nationwide with little to no public health benefit.

Call to action

The ACC coalition letter urges the EPA to take the following actions to correct the IRIS Program:

• Prohibit the use of IRIS assessments to develop, finalize, or issue a rule or regulation.
• Disband the IRIS Program, and return responsibilities to program offices.
• Respond to Information Quality Act requests for correction for recent IRIS assessments.
• Appoint and empower a science advisor who would report to the administrator and have authority for streamlining duplicative risk assessment activities.

“ACC also supports legislation in Congress, the No IRIS Act, that would protect American manufacturing and help ensure regulations are based on sound science,” states the ACC press release.

Just the beginning

More changes are planned for reorganizing EPA scientific priorities.

“Scientists who were on the call said they were left with the impression that if they did not move into one of the new areas, their current jobs might be eliminated,” The New York Times article says. “‘This feels like the Hunger Games,’ said one employee of the research office who spoke on condition of anonymity, for fear of retaliation. Other scientists will move into the administrator’s office as part of a new Office of Applied Science and Environmental Solutions, which Mr. Zeldin said would ‘put science at the forefront of the agency’s rule making.’”

Politicized assessment agenda?

Part of the Agency’s publicized reorganization plan includes the creation of the Office of Applied Science and Environmental Solutions (OASES) in the Office of the Administrator to align research with the EPA administrator’s priorities.

Analysts have pointed out the obvious: Aligning scientific research with the EPA administrator’s priorities isn’t an impartial foundation.

Critics of the reorganization disagree that science is being used correctly. Many have accused the Agency of politicizing EPA research.

“This so-called ‘reorganization’ is a thinly veiled attempt to extinguish the agency’s world-renowned scientific expertise by shuffling scientists to process chemical reviews for industry,” Representative Chellie Pingree, Democrat of Maine, said in a statement, according to The New York Times.

The research office “is intentionally separate from E.P.A.’s policy offices, ensuring it produces unbiased studies,” said Chitra Kumar, the managing director of the climate program at advocacy group the Union of Concerned Scientists. Moving the scientists into policy offices “could subject those experts to political influence, particularly in this administration.”