01/17/2025

EPA Floats New EtO Limits for Smaller Chemical Plants Ahead of Trump

Inside EPA | Stuart Parker | Jan. 16, 2025

EPA Floats New EtO Limits for Smaller Chemical Plants Ahead of Trump

EPA is planning new limits on emissions of the solvent ethylene oxide (EtO) from smaller “area source” chemical plants, along with tougher requirements for pressure relief devices, a facility fenceline air monitoring program and new leak detection and repair mandates, but the plan faces seemingly slim prospects under the Trump administration.

In a notice signed by Acting EPA Administrator Jane Nishida Jan. 8, but not yet published in the Federal Register, EPA says it is tightening controls under the existing National Emission Standards for Hazardous Air Pollutants (NESHAP) for Chemical Manufacturing Area Sources (CMAS) that covers nine industry sectors.

EPA is further adding a new source category under the NESHAP specifically to cover chemical manufacturing process units (CMPUs) using EtO as a feedstock, producing EtO or emitting EtO as a byproduct.

“We estimate that the proposed amendments to the CMAS NESHAP, excluding the proposed EtO emission standards, would reduce hazardous air pollutant (HAP) emissions from emission sources by approximately 158 tons per year (tpy). Additionally, the proposed EtO emission standards are expected to reduce EtO emissions by approximately 4.6 tpy,” EPA says.

Area sources are defined as those emitting less than 10 tons per year (tpy) of one HAP, or 25 tpy of a combination of HAPs. Sources emitting above these thresholds are classified as “major” and subject to tougher controls.

EPA will take public comment for 60 days following publication in the Federal Register. If the Biden administration does not publish in the Register before the presidential transition on Jan. 20, the Trump administration could withdraw the proposal from publication.

However, EPA issued the proposal under an extended Jan. 15 consent decree deadline agreed with environmentalists, and the decree requires a final rule by Jan. 15, 2026, limiting the Trump team’s options.

In total, the new rule would apply to the following source categories: Agricultural Chemicals and Pesticides Manufacturing, Chemical Manufacturing with Ethylene Oxide, Cyclic Crude and Intermediate Production, Industrial Inorganic Chemical Manufacturing, Industrial Organic Chemical Manufacturing, Inorganic Pigments Manufacturing, Miscellaneous Organic Chemical Manufacturing, Plastic Materials and Resins Manufacturing, Pharmaceutical Production, and Synthetic Rubber Manufacturing.

EPA says the tougher EtO controls are required in the light of its 2016 Integrated Risk Information System (IRIS) assessment that found cancer risks from EtO far higher than previously thought.

“Based on the revised carcinogenicity of EtO, the EPA decided to assess whether EtO emissions from CMAS should be listed as an area source category,” the agency says.

Industry groups and Texas, meanwhile, oppose the IRIS value as excessively conservative, arguing in litigation over “major source” chemical air toxics and sterilizers rules that it overstates risk. Texas promotes using its own alternative assessment that finds EtO risks far lower.

Urban HAPs

EtO is not one of the fifteen urban HAPs currently regulated by the CMAS NESHAP. “Therefore, to fully assess whether a source category including EtO emissions from area source chemical manufacturing operations presents an adverse effect to human health or the environment, facilities not currently part of the nine regulated source categories were considered,” EPA says.

“To that end, we conducted a risk assessment evaluating all reported HAP emissions from sources currently subject to the CMAS NESHAP as well as sources that we believe would become subject to the CMAS NESHAP if EtO were to be added.”

Seven area source chemical manufacturing facilities were estimated to have maximum cancer risks greater than 100-in-1 million, EPA’s typical benchmark for requiring controls, “all of which were driven primarily (greater than 90 percent) by EtO emissions.”

“Given these estimates of risk, we propose that an area source category associated with EtO emissions from area source chemical manufacturers presents a threat of adverse effect on human health,” EPA says.

Area source NESHAPs normally require generally available control technology (GACT), a less-stringent level of control than the maximum achievable control technology (MACT) needed for major sources. Also, “GACT differs from MACT in that cost can be considered in the first instance when establishing a GACT standard.”

EPA is “proposing to set additional GACT standards for the CMAS categories that would apply to certain emission sources (i.e., equipment leaks, heat exchange systems, process vents, storage tanks, wastewater, and transfer operations) associated with the proposed area source category, Chemical Manufacturing with Ethylene Oxide. In addition, we are proposing to set GACT standards for pressure vessels” and pressure relief devices.

EPA Finalizes TSCA Risk Evaluation for Diisononyl Phthalate (DINP)

Today, the U.S. Environmental Protection Agency (EPA) released the final risk evaluation for diisononyl phthalate (DINP) conducted under the Toxic Substances Control Act (TSCA). EPA has determined that DINP presents an unreasonable risk of injury to human health, because workers could be exposed to high concentrations of DINP in mist when spraying adhesive, sealant, paint, and coating products that contain DINP. DINP can cause developmental toxicity and harm the liver and can cause cancer at higher rates of exposure. Also, DINP can harm the developing male reproductive system, known as “phthalate syndrome” (e.g., decreased fetal testicular testosterone, male reproductive tract malformations, male nipple retention, and decreased male fertility). Therefore, EPA is including DINP in its cumulative risk analysis for six phthalates that demonstrate effects consistent with phthalate syndrome. This draft risk analysis was released earlier this month.

DINP is used as a plasticizer to make flexible polyvinyl chloride (PVC) and to make building and construction materials; automotive articles; and other commercial and consumer products including adhesives and sealants, paints and coatings, and electrical and electronic products.

Uses and Risks Associated with DINP

EPA conducted the risk evaluation for DINP at the manufacturer’s request. Under TSCA, manufacturers can request that EPA conduct risk evaluations on chemicals they manufacture. EPA received and granted this manufacturer request for a risk evaluation of DINP in 2019.

Workers may be exposed to DINP when making products or otherwise using DINP in the workplace. When it is manufactured or used to make products, DINP can be released into the water where most will end up in the sediment at the bottom of lakes and rivers. If released into the air, DINP will attach to dust particles and be deposited on land or into water. Indoors, DINP has the potential over time to come out of products and adhere to dust particles. If it does, people could inhale or ingest dust that contains DINP.

In the risk evaluation, EPA has determined that DINP poses unreasonable risk of injury to human health when workers are exposed to the chemical under four conditions of use that represent approximately 3% of the DINP production volume in the U.S. EPA found that workers are at risk if they are unprotected from the DINP contained in spray-applied adhesives and sealants, and paints and coatings. Spraying these products could create high concentrations of DINP in mist that an unprotected worker could inhale. EPA did not identify risk of injury to human health for consumers or the general population or the environment that would contribute to the unreasonable risk of DINP.

EPA did not evaluate uses and potential exposure pathways that are excluded by statute from TSCA, such as food additives or cosmetics. Past assessments, including the U.S. Consumer Product Safety Commission's risk assessment, found that DINP exposure comes primarily from diet for women, infants, toddlers, and children. While it is possible that DINP could pose risks to human health through uses or exposure pathways that are not regulated under TSCA, EPA’s risk evaluation and unreasonable risk determination cannot be extrapolated to form conclusions about uses of DINP that are not subject to TSCA, and that EPA did not evaluate.

Next Steps

EPA will now begin the risk management process to address the unreasonable risk presented by DINP. EPA will release a proposed rule under TSCA section 6 to protect workers from the identified risks.

Read the final risk evaluation for DINP.

Additional Information

Conditions of Use that Significantly Contribute to the Unreasonable Risk:

• Industrial use – adhesives and sealant chemicals (sealant (barrier) in machinery manufacturing; computer and electronic product manufacturing; electrical equipment, appliance, component manufacturing, and adhesion/cohesion promoter in transportation equipment manufacturing);
• Industrial use – construction, paint, and metal products – paints and coatings;
• Commercial use – construction, paint, electrical, and metal products – adhesives and sealants; and
• Commercial use – construction, paint, electrical, and metal products – paints and coatings.

Conditions of Use that Do Not Significantly Contribute to the Unreasonable Risk:

• Manufacturing – domestic manufacturing;
• Manufacturing – importing;
• Processing – incorporation into a formulation, mixture, or reaction product – heat stabilizer and processing aid in basic organic chemical manufacturing;
• Processing – incorporation into a formulation, mixture, or reaction product – plasticizers (adhesives manufacturing, custom compounding of purchased resin; paint and coating manufacturing; plastic material and resin manufacturing; synthetic rubber manufacturing; wholesale and retail trade; all other chemical product and preparation manufacturing; ink, toner, and colorant manufacturing (including pigment));
• Processing – incorporation into an article – plasticizers (toys, playground and sporting equipment manufacturing; plastics products manufacturing; rubber product manufacturing; wholesale and retail trade; textiles, apparel, and leather manufacturing; electrical equipment, appliance, and component manufacturing; ink, toner, and colorant manufacturing (including pigment));
• Processing – other uses – miscellaneous processing (petroleum refineries; wholesale and retail trade);
• Processing – repackaging – plasticizer (all other chemical product and preparation manufacturing; wholesale and retail trade; laboratory chemicals manufacturing);
• Processing – recycling;
• Distribution in commerce;
• Industrial use – construction, paint, electrical, and metal products – building/construction materials (roofing, pool liners, window shades, flooring, water supply piping);
• Industrial use – other uses – hydraulic fluids;
• Industrial use -other uses – pigment (leak detection);
• Industrial use – other – automotive articles;
• Commercial use – construction, paint, electrical, and metal products – plasticizer in building/construction materials (roofing, pool liners, window shades, water supply piping); construction and building materials covering large surface areas, including paper articles; metal articles; stone, plaster, cement, glass, and ceramic articles;
• Commercial use – construction, paint, electrical, and metal products – electrical and electronic products;
• Commercial use – furnishing, cleaning, treatment/care products – foam seating and bedding products; furniture and furnishings including plastic articles (soft); leather articles;
• Commercial use – furnishing, cleaning, treatment/care products – air care products;
• Commercial use – furnishing, cleaning, treatment/care products – floor coverings; plasticizer in construction and building materials covering large surface areas including stone, plaster, cement, glass, and ceramic articles; fabrics, textiles and apparel (vinyl tiles, resilient flooring, PVC-backed carpeting);
• Commercial use – furnishing, cleaning, treatment/care products – fabric, textile, and leather products (apparel and footwear care products);
• Commercial use – packaging, paper, plastic, hobby products – arts, crafts, and hobby materials;
• Commercial use – packaging, paper, plastic, hobby products – ink, toner, and colorant products;
• Commercial use – packaging, paper, plastic, hobby products – packaging, paper, plastic, hobby products (packaging (excluding food packaging), including rubber articles; plastic articles (hard); plastic articles (soft));
• Commercial use – packaging, paper, plastic, hobby products – plasticizer (plastic and rubber products; tool handles, flexible tubes, profiles, and hoses);
• Commercial use – packaging, paper, plastic, hobby products – toys, playground, and sporting equipment;
• Commercial use – solvents (for cleaning or degreasing) – solvents (for cleaning or degreasing);
• Commercial use – other uses – laboratory chemicals;
• Commercial use – other – automotive articles;
• Consumer use – construction, paint, electrical, and metal products – adhesives and sealants;
• Consumer use – construction, paint, electrical, and metal products – plasticizer in building/construction materials (roofing, pool liners, window shades, water supply piping, etc.);
• Consumer use – construction, paint, electrical, and metal products – electrical and electronic products;
• Consumer use – construction, paint, electrical, and metal products – paints and coatings;
• Consumer use – furnishing, cleaning, treatment/care products – floor coverings/plasticizer in construction and building materials covering large surface areas including stone, plaster, cement, glass, and ceramic articles; fabrics, textiles and apparel (vinyl tiles, resilient flooring, PVC-backed carpeting);
• Consumer use – furnishing, cleaning, treatment/care products – foam seating and bedding products; furniture and furnishings including plastic articles (soft); leather articles;
• Consumer use – furnishing, cleaning, treatment/care products – air care products;
• Consumer use – furnishing, cleaning, treatment/care products – fabric, textile, and leather products (apparel and footwear care products);
• Consumer use – packaging, paper, plastic, hobby products – arts, crafts, and hobby materials;
• Consumer use – packaging, paper, plastic, hobby products – ink, toner, and colorant products;
• Consumer use – packaging, paper, plastic, hobby products – other articles with routine direct contact during normal use including rubber articles; plastic articles (hard); vinyl tape; flexible tubes; profiles; hoses;
• Consumer use – packaging, paper, plastic, hobby products – packaging (excluding food packaging), including rubber articles; plastic articles (hard); plastic articles (soft);
• Consumer use – packaging, paper, plastic, hobby products – toys, playground, and sporting equipment;
• Consumer use – other – novelty articles;
• Consumer use – other – automotive articles; and
• Disposal.