EPA Admits Its Chemical Rules Were Not OptimalNow 80 Industries Are Racing To Rewrite The Playbook

Written by Published

Catfish farmers, funeral directors, miners and a wide range of other industries have successfully pressed the Environmental Protection Agency to dismantle a four-decade-old chemical risk framework that many say has throttled American enterprise with dubious science.

The shift came in late April, when EPA Deputy Administrator David Fatouhi circulated an internal memorandum formally terminating the agencys 1985 Integrated Risk Information System, or IRIS, the long?standing mechanism for classifying hazardous chemicals. According to Western Journal, the move follows years of mounting criticism from businesses and scientific advocates who argued that IRIS routinely exaggerated the dangers of certain compounds, driving costly regulations that bore little relationship to real?world risk.

IRIS was never enacted by Congress; it was created administratively and then steadily expanded, giving unelected bureaucrats sweeping influence over how chemicals are labeled and controlled. Over time, its toxicological assessments became so pervasive that more than 80 industry organizations from agriculture to energy to funeral services joined an American Chemistry Council (ACC) letter to EPA Administrator Lee Zeldin in January 2025, urging the agency to rein in or dismantle the program.

The systems toxicity values, including carcinogenicity estimates and daily safe exposure levels, have been used as the backbone for a host of federal and state regulatory schemes. EPA program offices relied on IRIS numbers to set climate superfund cleanup thresholds, shape air quality standards, and guide risk evaluations under the Toxic Substances Control Act, even as states used those benchmarks to justify climate superfund laws that force fossil fuel companies to pay for alleged climate?related damages.

In his April 27 memo, Fatouhi acknowledged that IRIS had strayed far from its original purpose of promoting internal consistency in risk assessments. 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, Fatouhis memo reads.

He went on to concede that centralizing those judgments in a single office had produced one?size?fits?all standards that often ignored the legal and practical realities of specific statutes. 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.

Fatouhis letter singled out one of the most controversial IRIS determinations: the toxicity value for ethylene oxide, a compound essential for sterilizing medical equipment. The memo noted 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 continuing to run chemical hazard classifications through a centralized IRIS office, the EPA will now devolve that authority to its individual program offices. These specialized divisions which administer statutes such as the Clean Air Act and Atomic Energy Act will be responsible for tailoring risk assessments to the specific legal frameworks and scientific contexts in which they operate.

The reaction from industry was swift and largely favorable, reflecting long?standing frustration with what many see as regulatory overreach driven by worst?case assumptions. For sectors that depend on chemicals demonized by IRIS, the policy reversal represents not only regulatory relief but also a vindication of their warnings about the economic and scientific costs of the old regime.

Funeral directors, whose work relies heavily on formaldehyde, were among those who had sounded the alarm about IRIS?based restrictions. 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.

Witter argued that IRIS had effectively threatened the availability of a tool that is both time?tested and professionally managed. Our members have been concerned about access to this critical tool due to regulations based on a flawed IRIS value for formaldehyde. Were happy to see EPA moving away relying on unrealistic IRIS assessments and relying on high-quality Gold Standard science moving forward.

The NFDA joined forces with an eclectic coalition that included the Catfish Farmers of America and the National Mining Association (NMA), underscoring how widely IRIS assessments had rippled across the economy. These groups contended that the programs toxicity thresholds were often set so low that they bore no resemblance to natural background levels or everyday human exposure.

One chemical industry source, speaking anonymously due to the sensitivity of ongoing policy discussions, highlighted the absurdity of some IRIS benchmarks. EPAs 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.

Mining interests, which have long battled stringent standards for naturally occurring substances, echoed that criticism and welcomed the EPAs course correction. 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.

The NMA spokesperson praised the agencys decision to shift risk assessment work to a new structure that, in their view, is more grounded in empirical evidence and statutory reality. We applaud the EPAs 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), which represents specialty and boutique chemical producers, also endorsed the dismantling of IRIS. The group has long argued that the programs opaque processes and rigid assumptions undermined innovation and predictability for smaller manufacturers that lack the resources of multinational conglomerates.

SOCMA has previously raised concerns about the EPAs 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.

Another industry official pointed to IRIS treatment of hexavalent chromium as a case study in regulatory excess. 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.

Such standards, the official warned, would have forced water systems nationwide into costly compliance efforts with no demonstrable health benefit. The IRIS thresholds, they said, would have imposed massive costs on water systems nationwide with no measurable improvement in public health outcomes.

Even as the private sector welcomed the EPAs internal reforms, the American Chemistry Council argued that the job is not finished. ACC Vice President of Regulatory and Scientific Affairs Dr. Kimberly Wise White stressed that IRIS has been flagged for years by federal watchdogs as a program vulnerable to mismanagement and abuse.

ACC has highlighted concerns about EPAs IRIS program, which has lacked scientific rigor and remains on the GAOs 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.

On Capitol Hill, conservatives are moving to lock in the EPAs shift away from IRIS through statute, rather than leaving it to the discretion of future administrations. Republican Rep. Glenn Grothman of Wisconsin introduced the No Industrial Restrictions in Secret (No IRIS) Act in February 2025, aiming to codify the Trump?era EPAs restructuring and prevent a future White House from quietly resurrecting the old framework.

Grothman, a consistent critic of bureaucratic overreach, argued that IRIS had effectively imposed unattainable standards on small and mid?sized businesses. In too many cases, IRIS assessments pushed impractical toxicity standards and emissions thresholds far below naturally occurring ambient levels. Thats a direct hit on small businesses who dont have the resources to chase ever-changing or unattainable standards, the lawmaker told the DCNF.

He warned that when regulators set targets that cannot realistically be met, the result is not cleaner air or safer water but economic paralysis and offshoring. When you set targets that are effectively impossible to meet, you dont 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. Thats exactly what weve seen, particularly for manufacturers and small operators trying to stay competitive.

In the Senate, Republican John Kennedy of Louisiana has introduced a companion version of the No IRIS Act, signaling that the effort has support in both chambers. The bill has been referred to the Committee on Environment and Public Works, where its fate will test whether Congress is willing to rein in an entrenched regulatory apparatus that has often operated with minimal oversight.

Grothman expressed cautious optimism that the EPAs internal reforms, combined with legislative action, could restore a more balanced approach to environmental protection. Im 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.

He also framed the debate in global terms, arguing that driving industry out of the United States in the name of hyper?precautionary standards ultimately harms the environment. 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.

For conservatives, the dismantling of IRIS and the push for the No IRIS Act represent more than a technical adjustment in how the EPA crunches numbers. They see it as a broader course correction away from a regulatory culture that has too often treated economic growth and job creation as collateral damage in pursuit of theoretical risks modeled far from the realities of the marketplace.

The debate now shifts to whether Congress will cement this change and whether future administrations will respect the principle that risk assessments must be grounded in transparent, reproducible science rather than ideological precaution. With industries from catfish farming to funeral services and mining lining up behind the reforms, the political momentum appears to favor a more decentralized, statute?driven approach to chemical regulation that respects both human health and the economic backbone of the country.