Document 2jk376K73rJ1JMyR9q0XvX7Bp

American' Chemistry Council January 27, 2025 The Honorable Lee Zeldin Administrator-nominee Environmental Protection Agency Dear Administrator-nominee Zeldin: America's economic competitiveness and national security depend on a supply chain that is dependable and resilient. At the start of virtually every supply chain are chemistries needed to manufacture a wide range of critical products. Chemical management policies that are both predictable and based on findings supported by high quality information are fundamental to promoting American innovation and strengthening our economy. The Environmental Protection Agency's (EPA's) risk evaluations and risk management policies for chemicals must be based on the best available science. That's why we write to bring to your attention an important issue impacting American jobs and economic competitiveness that fails to meet that standard. The EPA's Integrated Risk Information System (IRIS) program has been increasingly used to develop overly burdensome regulations on critical chemistries essential for products we use every day. IRIS has often fallen short of scientific standards required of EPA and is out of step with global health agencies and regulators. IRIS fails to adequately incorporate high quality and relevant science and does not consistently utilize a "weight of the scientific evidence" approach. Also, the process IRIS uses to prioritize and select chemicals for assessment lacks transparency. Controversy over EPA's IRIS process, the resulting hazard values, and the use of those values is not a new phenomenon. Specific concerns include: a lack of impa- l tality in accurately reporting scientific information, scientific inaccuracy, lack of transparency, limited peer review, and slow progress in producing assessments - these issues and others have been raised by Congress on many occasions. Moreover, Congress has never authorized IRIS and since 2009 the program has been flagged as a "high risk" program vulnerable to waste, fraud, abuse, or mismanagement by the U.S. Government Accountability Office (GAO). EPA's IRIS values fail to go through regular rulemaking checks related to notice-and-comment, interagency review, and engagement with stakeholders. 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. Despite these concerns, EPA has relied on IRIS assessments in regulatory contexts, particularly for critical building block chemicals. These actions could result in bans, unachievable standards, enforcement actions, and litigation. 700 Second Street NE, Washington DC 20002 1 202.249.7000 1 americanchernistrv.com Sierra Club FOIA Request: 2025-EPA-04193 1 ED_018475D_00003772-00001 SC_FOIA_0000205 American' Chemistry Council Some recent examples of agencies using IRIS include: Final Formaldehyde Risk Evaluation: EPA recently issued its final risk evaluation under the Toxic Substances Control Act (TSCA) that was based on a flawed IRIS assessment. EPA's final risk evaluation concludes that virtually all occupational conditions of use contribute to "unreasonable risk" under TSCA. The TSCA risk evaluation for formaldehyde relies on a faulty IRIS value to propose workplace limits that are significantly lower than the recently updated European Union occupational limits and could result in potential bans or difficult-to-meet standards for some uses. EPA has received fundamental criticism from multiple peer review bodies and public comments provided by hundreds of experts, stakeholders, and other agencies. Members of the EPA's own Science Advisory Committee on Chemicals (SACC) have raised serious concerns over EPA's reliance on IRIS. EPA Air Rules on Ethylene Oxide: These rules affect critical industries like electric vehicles, semiconductor manufacturing, and health care. The rules rely on a deeply flawed IRIS value for ethylene oxide that is 23,000 times lower than naturally occurring levels in the human body. Biden Administration DOJ Action: An IRIS value was used to justify emergency action seeking to shut down a manufacturing facility under Section 303 of the Clean Air Act. IRIS Toxicological Review of Inorganic Arsenic: Proposes a controversial cancer risk value that is 21 times more stringent than the current value. The values from IRIS assessments 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 IRIS Review of Hexavalent Chromium: EPA's recent IRIS assessment 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. We urge you and your team to take steps quickly to address problems with the IRIS program, including: Prohibiting the use of IRIS assessments to develop, finalize, or issue a rule or regulation; Disbanding the IRIS program and returning responsibilities to program offices; Being responsive to Information Quality Act requests for correction for recent IRIS assessments; and Appointing and empowering a Science Advisor reporting to the Administrator and with authority for streamlining duplicative risk assessment activities. We thank you for your attention to this important issue and look forward to working with you. Sincerely, 700 Second Street NE, Washington DC 20002 1 202.249.7000 1 americanchernistrv.com Sierra Club FOIA Request: 2025-EPA-04193 2 ED_018475D_00003772-00002 SC_FOIA_0000206 American Chemistry Council Adhesive and Sealant Council Agricultural Retailers Association Alliance for Chemical Distribution American Cleaning Institute American Coatings Association American Composites Manufacturers Association American Feed Industry Association American Foundry Society American Fuel and Petrochemical Manufacturers American Home Furnishings Alliance American Petroleum Institute America nHort Arsenic Science Task Force Arsenical Wood Preservatives Task Force Asphalt Roofing Manufacturers Association Battery Council International Can Manufacturers Institute Catfish Farmers of America Chlorine Panel of the American Chemistry Council Color Pigments Manufacturers Association, Inc. Communications Cable and Connectivity Association Decorative Hardwoods Association Essential Minerals Association Ethylene Oxide Panel of the American Chemistry Council Ethylene Oxide Sterilization Association Extruded Polystyrene Foam Association (XPSA) Far West Agribusiness Association Florida Tropical Fish Farms Association Hawaii Aquaculture and Aquaponics Association Illinois Farm Bureau INDA, Association of the Nonwoven Fabrics Industry Independent Lubricant Manufacturers Association Institute of Makers of Explosives International Sleep Products Council International Wood Products Association Iowa Farm Bureau Kitchen Cabinet Manufacturers Association Louisiana Chemical Association Metal Construction Association National Aquaculture Association National Asphalt Pavement Association National Association for Surface Finishing National Association of Manufacturers 700 Second Street NE, Washington DC 20002 1 202.249.7000 1 americanchernistrv.com Sierra Club FOIA Request: 2025-EPA-04193 American' Chemistry Council 3 ED_018475D_00003772-00003 SC_FOIA_0000207 National Association of Printing Ink Manufacturers National Cotton Council National Electrical Manufacturers Association National Funeral Directors Association National Mining Association National Wood Flooring Association Non-Ferrous Founders' Society North American Metals Council North Carolina Manufacturers Alliance Northwest Aquaculture Alliance Ohio AgriBusiness Association Ohio Chemistry Technology Council Organic Arsenical Products Task Force Performance Racing Industry (PRI) Pine Chemicals Association International Plastics Industry Association (PLASTICS) Plumbing Manufacturers International Polyisocyanurate Insulation Manufacturers Association Polyurethane Foam Association PRINTING United Alliance RadTech International North America Inc Society of Chemical Manufacturers &Affiliates Specialty Equipment Market Association (SEMA) Spray Polyurethane Foam Alliance Steel Founders' Society of America The Fertilizer Institute The Hardwood Federation The Styrene Information and Research Center (SIRC) The Toy Association Treated Wood Council TRSA --The Linen, Uniform and Facility Services Association U.S. Chamber of Commerce USA Rice Utility Water Act Group (UWAG) Vinyl Institute West Virginia Forestry Association West Virginia Manufacturers Association American' Chemistry Council CC: Russell Vought, Director-nominee, Office of Management and Budget 700 Second Street NE, Washington DC 20002 1 202.249.7000 1 americanchernistrv.com Sierra Club FOIA Request: 2025-EPA-04193 4 ED_018475D_00003772-00004 SC_FOIA_0000208