In August, the Environmental Protection Agency released the finalized IRIS Toxicological Review of Formaldehyde that addressed the potential cancer and noncancer human health effects from inhalation exposure to formaldehyde.
Industry groups have questioned the methodology of the assessment, what they call "regulatory overreach," and worry that the assessment will lead to additional regulations.
The assessment specifically focuses on the following health effects: sensory irritation; pulmonary function; immune system effects, focusing on allergic conditions and asthma; respiratory tract pathology; nervous system effects; reproductive and developmental toxicity; and cancer. For cancer, the assessment focuses on cancers of the upper respiratory tract (including nasopharyngeal
cancer, sinonasal cancer, cancers of the oropharynx/hypopharynx, and laryngeal cancer in humans) and of the lymphohematopoietic system (including Hodgkin lymphoma, multiple myeloma, myeloid leukemia, and lymphatic leukemia in humans).
Among the EPA's findings were:
- Inhaled formaldehyde can cause health effects in humans, most notably respiratory effects. Children and those with respiratory disease appear to be most susceptible.
- Formaldehyde is carcinogenic to humans by the inhalation route of exposure.
Industry groups were quick to question the assessment. The National Association of Manufacturers, in an online policy post said The formaldehyde analysis risks “creat[ing] an unachievable standard and a de facto ban” on an essential manufacturing material
NAM added that the assessment maintains the formaldehyde threshold of 11 parts per billion proposed by the agency in 2022. That’s 30 times lower than Europe’s recently updated worker-exposure limit of 300 parts per billion and “lower than what can be found in homes or even background levels for outdoor air,” the NAM told the EPA.
The American Chemistry Council's (ACC) Formaldehyde Panel issued the following statement on the IRIS Assessment of Formaldehyde:
"As required under the Toxic Substances Control Act (TSCA), any assessment of formaldehyde must begin with the best available science. This assessment fails that test and is therefore unfit for regulatory decision-making. EPA’s final assessment fails to reflect fundamental criticism from multiple peer review bodies or public comments provided by hundreds of experts, stakeholders, and other agencies. The Agency is on a path to ignore applicable scientific standards and procedural requirements, and issue unscientific and legally unsound regulatory actions based on this flawed assessment under TSCA and other laws later this year.
“If EPA continues on its current path, formaldehyde manufacturing and many of its downstream uses could be severely restricted or potentially banned in the U.S., with an overwhelmingly negative impact on the environment, human health, national security, and the economy."
Groups with direct ties to the wood products industry also argued against the assessment. The Decorative Hardwoods Association (DHA) recently joined allies in a letter to members of Congress opposing the use of IRIS risk assessments in regulatory determinations. "Despite all of the comments and criticisms of the underlying assessment, the final assessment retains most of EPA's original conclusions and no changes to the IRIS values," wrote Keith Christman, president of the DHA, in a recent post
The Environmental Protection Agency’s final formaldehyde analysis does not mandate any new restrictions on industry, but may lead to a final risk evaluation that will.
Fighting IRIS
Congressman Glenn Grothman (R-WI) and Senator John Kennedy (R-LA) introduced the No Industrial Restrictions in Secret Act (No IRIS Act) to "reduce undue red tape" imposed by the EPA'S Integrated Risk Information System (IRIS). This bill is supported by the American Chemistry Council and a variety of other groups.
For instance, on September 9, the DHA, the Kitchen Cabinet Manufacturers Association (KCMA), and the Composite Panel Association joined 50 other national associations in supporting the No Industrial Restrictions in Secret (NO IRIS) Act of 2024 (S. 3724/H.R. 7284).
The bill seeks to prohibit EPA from using Integrated Risk Information System (IRIS) assessments for regulatory decisions. The IRIS program, which the congressman said "lacks Congressional authorization," has previously influenced some of EPA’s chemical use restrictions. CPA supports this legislation to limit the potential for the formaldehyde IRIS assessment to be used to negatively impact the manufacturing and use of composite panels. Although the bill's passage this year is unlikely, it helps raise awareness of the issue in Congress, according to the CPA.
Background
The EPA established the IRIS program in 1985 to gather data on how chemicals impact human health, however, it was never authorized by Congress.
IRIS has relied on flawed scientific data, disregarded relevant information, and dismissed public input. Despite the program’s inherent flaws, it creates chemical threshold assessments that have had devastating consequences for private industries.
"There needs to be a change in the way EPA conducts its business around scientific integrity and accountability in the way in which the federal government conducts chemical risk evaluations," Grothman said.
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