Under the recently amended Toxic Substances Control Act (TSCA), EPA is bound by new requirements and enforceable timetables to complete risk assessments for chemicals manufactured, distributed and imported to the United States.

In October, EPA listed the first five chemicals subject to new, expedited risk assessments. On November 29, EPA announced 10 other chemicals, bringing the list to 15 chemicals that the agency must now evaluate for risks to human health and the environment. The 10 chemicals are drawn from EPA’s TSCA Work Plan list of 90 chemicals prioritized for heightened Agency review, and EPA is required to consider additional chemicals from the Work Plan list.

In light of these requirements, companies with U.S. operations, and particularly manufacturers, should:

  • Evaluate what chemicals are used in their manufacturing processes, as product ingredients or elsewhere in their supply chain;
  • Determine whether those chemicals are likely to be prioritized in EPA’s new risk assessment process;
  • Based on when those chemicals are likely to undergo risk assessment, participate in the risk assessment process by submitting comments and information for EPA consideration; and
  • Consider the potential impacts of restrictions impacts on supply chains and manufacturing processes.

In addition, companies of all types should review the list of chemicals in EPA's TSCA Work Plan, determine whether those chemicals are part of their product or process lifecycles, and plan accordingly for future Agency actions.

Background

On June 22, 2016, the Frank R. Lautenberg Chemical Safety for the 21st Century Act overhauled TSCA’s risk assessment mechanisms for new and existing chemicals. Now, subject to specific rules on prioritization and specific timetables, the U.S. Environmental Protection Agency must conduct risk assessments for all chemical substances used in commerce that are not specifically exempted from TSCA. In 2014, EPA published a Work Plan , which listed 90 chemicals that were it wished to prioritize for purposes of risk assessments, and under the amended TSCA, EPA is required to perform additional risk assessments of chemicals from the Work Plan.

Under the revised statute, EPA must assess whether chemicals pose a risk to human health and/or the environment, and where a risk is identified to mitigate it with restrictions on use up to and including a ban on the chemical or a specific use. Where TSCA previously required EPA to include cost-benefit analysis in its risk assessment, the revised statute prohibits EPA from doing so. EPA must also consider whether restrictions are necessary to protect susceptible subpopulations (e.g., infants, elderly and pregnant women). Under the revised statute, third-parties, including industry members, environmental groups, and non-governmental organizations, may submit comments and information for EPA consideration during the risk evaluation process.

Companies must stay abreast of EPA restrictions on chemicals in both their manufacturing processes and their supply chains. Chemical risk assessments could lead to more stringent regulations that could be costly to companies that use chemicals anywhere in their product or process lifecycles. As a result, manufacturers, distributors and importers of chemicals, companies of all types should pay special attention to their supply chain to identify potential risk areas, especially if chemicals already designated by EPA for risk assessment are used. While future limitations are currently unknown, it may be prudent for companies to identify feasible alternatives to these targeted chemicals.

I. First 10 Chemicals Slated for Standard Risk Assessments

On November 29, 2016, EPA announced the first 10 chemicals to be evaluated for risks to human health and the environment under the revised TSCA’s ordinary risk assessment process. The newly listed chemicals are:

  • 1,4-Dioxane – a solvent for adhesives, cellulose esters and inks, and can also be an ingredient in paint strippers, dyes and waxes. The substance is also contained in antifreeze for automobile and aircraft deicing fluids. The selection of this chemical is consistent with the increased attention given to this chemical ever since EPA’s 2012 cancer risk assessment classified it as a likely human carcinogen.
  • 1-Bromopropane (1-BP) – a solvent in adhesives for aviation equipment maintenance, synthetic fiber production and in glue that binds cushions together. 1-BP is also a component of vapor sprays that degrease metal surfaces, plastics, electronics and optical components.
  • Cyclic Aliphatic Bromide Cluster – a flame retardant in extruded polystyrene foam, textiles, and electrical and electronic appliances.
  • Methylene Chloride – also known as Dichloromethane, this chemical is widely used as a paint stripper and a degreaser, but has also been used in the food and beverage industry to decaffeinate coffee and prepare extracts of hops. It is occasionally used in the process of removing heat-sealed printings on clothing, as well as in the manufacturing of photographic film.
  • N-methylpyrrolidone (NMP) – is used as a solvent for paint and coating removal products, and for surface treatment of textiles, resins and metal coated plastics. It is also recovers hydrocarbons generated in petrochemical processing and is used to absorb hydrogen sulfide from hydrodesulphurization facilities. NMP is also used frequently in lithium ion battery manufacturing.
  • Pigment Violet 29 – an organic compound used in vat dying and in metallic varnish to make a dark red, or “bourdeaux” color.
  • Tetrachloroethylene – a colorless liquid widely used in dry cleaning products, metal degreasers, paint strippers and some spot remover consumer products.
  • Carbon Tetrachloride – this chemical was once produced in vast quantities as a CFC refrigerant and used in fire extinguishers. Since the Montreal Protocol, the chemical is now used in small quantities as a degreasing agent and in paint removal products.