Catfish farmers, funeral home operators and miners — among a host of other industry groups — convinced the Environmental Protection Agency to kill its forty-year-old chemical regulation system.
EPA Deputy Administrator David Fatouhi issued a memo on April 27 ending the 1985 Integrated Risk Information System (IRIS) method of classifying hazardous chemicals. Numerous stakeholders have criticized IRIS for dramatically overestimating the toxicity for certain industry-specific compounds to many business’ detriment.
IRIS was implemented via administrative action and has never been approved by Congress. IRIS toxicological assessments are far-reaching enough that over 80 disparate industry groups signed on to an American Chemistry Council (ACC) open letter to EPA Secretary Lee Zeldin in January 2025.
IRIS-generated toxicity values include carcinogen estimations and daily pollutant exposure considered safe for human life. EPA program offices nationwide have used these metrics to establish climate superfund cleanup standards, air quality rules, and inform chemical risk evaluations under the Toxic Controlled Substances Act. Climate superfunds are state legislative initiatives that force fossil fuels companies to pay damages for supposed climate change harms.
“While the IRIS program was designed originally to promote consistency, the development of a risk assessment often includes science policy judgments – many of which are informed by statutory and regulatory authority and objectives,” Fatouhi’s memo reads. “Over the years, it has become more clear that having a single program within one office at EPA make these judgments for all hazard and dose-response assessments for all of EPA is not optimal for developing fit-for-purpose risk assessments tailored to meet specific legal, statutory, and regulatory obligations.”
The Deputy Administrator’s letter also notes that “the IRIS toxicity value for ethylene oxide (EtO), a chemical critical for medical equipment sterilization, has been criticized because it was at least 10,000 times lower than levels naturally occurring in the human body.”
Rather than using IRIS to issue hazard classifications for virtually every chemical, the EPA will devolve this responsibility to particular program offices. EPA program offices are specialized departments that exist to implement particular laws like the Atomic Energy Act and Clean Air Act.
Industry stakeholders responded positively to Fatouhi’s memo.
“Formaldehyde is a critical chemical used by funeral directors across America. Funeral directors are taught in mortuary school how to safely use formaldehyde,” National Funeral Directors Association (NFDA) Senior Vice President Lesley Witter told the Daily Caller News Foundation. “Our members have been concerned about access to this critical tool due to regulations based on a flawed IRIS value for formaldehyde. We’re happy to see EPA moving away relying on unrealistic IRIS assessments and relying on high-quality Gold Standard science moving forward.”
The NFDA was one of the signatories of the ACC’s January letter, along with groups such as the Catfish Farmers of America and the National Mining Association (NMA).
“EPA’s IRIS formaldehyde assessment set toxicity level below the amount of formaldehyde produced by human breath,” added a chemical industry source granted anonymity to discuss sensitive policy matters.
“In the past, IRIS risk assessments have applied overly conservative approaches that have driven regulatory standards arbitrarily lower—sometimes even below background levels—while offering little to no benefits,” an NMA spokesperson agreed. “We applaud the EPA’s revised approach through its newly formed Office of Applied Science and Environmental Solutions to conduct fact-based assessments moving forward.”
The Society of Chemical Manufacturers & Affiliates (SOCMA) also supports Fatouhi’s rescission of IRIS. “SOCMA has previously raised concerns about the EPA’s IRIS Program, particularly regarding transparency and the use of the best available science, and continues to support risk assessment approaches that are scientifically robust and predictable.” SOCMA is the only U.S. industry association representing boutique and specialty chemical manufacturers.
“Toxicity values in IRIS’ hexavalent chromium assessment would result in drinking water standards lower than average background levels of naturally occurring chromium in groundwater,” another industry official told the DCNF. The official noted that the IRIS standards “would have imposed massive costs on water systems nationwide” with no measurable improvement in public health outcomes.
Despite the move’s warm reception among the private sector, ACC Vice President of Regulatory and Scientific Affairs Dr. Kimberly Wise White told the DCNF there was more to be done.
“ACC has highlighted concerns about EPA’s IRIS program, which has lacked scientific rigor and remains on the GAO’s High-Risk List for programs that are vulnerable to fraud, waste, abuse, or mismanagement,” White said. “We have called for the disbandment of the IRIS program, the return of responsibilities to program offices, and also support legislation in Congress, the No IRIS Act that would help ensure regulations are based on high-quality science.”
Republican Wisconsin Rep. Glenn Grothman introduced the No Industrial Restrictions in Secret (No IRIS) Act in February 2025. Grothman is attempting to codify the Trump EPA’s statutory revisions.
“In too many cases, IRIS assessments pushed impractical toxicity standards and emissions thresholds far below naturally occurring ambient levels. That’s a direct hit on small businesses who don’t have the resources to chase ever-changing or unattainable standards,” the lawmaker told the DCNF. “When you set targets that are effectively impossible to meet, you don’t get better outcomes; you get stalled projects, fewer jobs, less innovation, and manufacturing outsourced to countries whose scientific standards are already more lax than the United States. That’s exactly what we’ve seen, particularly for manufacturers and small operators trying to stay competitive.”
Republican Louisiana Sen. John Kennedy introduced the No IRIS Act to the Senate alongside Grothman. It has been referred to the Committee on Environment and Public Works.
“I’m encouraged to see the EPA taking steps to address these issues and moving toward a more transparent, accountable process grounded in sound science. That should provide much-needed certainty for job creators and help ensure that environmental protections go hand-in-hand with economic growth,” Grothman added. “If we truly care about reducing emissions worldwide, it needs to be a priority to keep manufacturing in the United States in a manner that reflects Gold Standard Science.”
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