US EPA announces plans for chemical risk evaluations under TSCA

On 30 June 2021, the Environmental Protection Agency (EPA) announced policy changes regarding risk evaluations under the Toxic Substances Control Act (TSCA), and the path forward for the first 10 chemicals to undergo risk evaluation. The Agency's announcement included the following changes:

Expanding consideration of exposure pathways and fenceline community exposure screening level approach

General population exposure via air, water or disposal were not assessed during the first 10 risk evaluations because these exposure pathways were regulated or could be regulated under other EPA-administered statutes (i.e. the Clean Air Act, Safe Drinking Water Act, or Clean Water Act). The exclusion of some exposure pathways resulted in a failure to completely address potential exposures to exposed or susceptible subpopulations, including fenceline communities. EPA will examine whether excluding exposure pathways from risk evaluations will lead to a failure to identify and protect fenceline communities for six of the first ten chemicals. These six chemicals are:

1. Methylene Chloride
2. Trichloroethylene
3. Carbon Tetrachloride
4. Perchloroethylene
5. NMP
6. 1-bromopropane

EPA is developing a screening-level approach to conduct ambient air and surface water fenceline assessments using existing data and information to determine if such exposures could cause unreasonable risks. If this approach determines that there is no unreasonable risk to these communities, EPA will move forward with proposed risk management rules. If unreasonable risks are found that cannot be addressed, the Agency will conduct a more detailed exposure assessment and augment its risk evaluation with new information. EPA will make these screening approaches available for public comment later this year.

Use of Personal Protective Equipment (PPE)

EPA is also reassessing the assumption made by the previous administration during the final risk evaluations for the first 10 chemicals, that PPE is always used in occupational environments. To address this, the Agency will consider data on how industry protects workers with PPE or other methods. For six of the first ten chemicals where "no unreasonable risk" findings were made based on the use of PPE, conclusions might be altered. This shift may affect the conclusions about the risks associated with the following chemicals:

1. Methylene Chloride
2. 1-bromopropane
3. HBCD
4. NMP
5. Perchloroethylene
6. 1,4-dioxane

Whole chemical approach

Previously, EPA made separate determinations of unreasonable risk for every condition of use of a chemical. For the first ten chemicals and similar chemicals for which significant risks exist across many uses, EPA will assess and analyze each condition of use. EPA plans to make the unreasonable risk determination just once for the whole chemical when it is clear the majority of the conditions of use warrant a single determination. Any previous orders will be withdrawn for those conditions of use for which no unreasonable risk was determined for all of the first 10 risk evaluations. A revised unreasonable risk determination for these chemicals will then be issued under the "whole substance" approach, and will request public comment on this approach.

How TSG can help

TSG’s consultants are well versed in all aspects of chemical compliance under TSCA. TSG’s consultants can assist with the best regulatory approach for your products that may be impacted by any rules EPA may promulgate as part of the approach to risk management. Have a question? Get in touch: [email protected]