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.
|
