MIL-OSI USA: EPA Announces Path Forward for TSCA Chemical Risk Evaluations

4

Source: US Environment Protection Agency

News Releases from HeadquartersChemical Safety and Pollution Prevention (OCSPP)

06/30/2021

Contact Information: 

WASHINGTON (June 30, 2021) — Today, the U.S. Environmental Protection Agency (EPA) announced important policy changes surrounding risk evaluations issued under the Toxic Substances Control Act (TSCA) by the previous administration and the path forward for the first 10 chemicals to undergo risk evaluation. After agency review to ensure these risk evaluations follow science and the law, EPA announced risk management actions to ensure these chemicals are used safely and all communities are protected. This review was done in accordance with the Biden-Harris Administration’s Executive Orders and other directives, including those on environmental justice, scientific integrity, and regulatory review.
 
“EPA is committed to ensuring the safety of chemicals used in all communities, including those that have been historically underserved,” said EPA Office of Chemical Safety and Pollution Prevention Assistant Administrator Michal Freedhoff. “The policy changes and path forward announced today will allow the agency to restore public trust, provide regulatory certainty, and most importantly, ensure that all populations that may be exposed to these chemicals are protected.”

TSCA requires EPA to review the risks associated with high-priority chemicals already on the market, then take action to manage any unreasonable risks found. Today’s announcement includes the following changes and will position EPA to move forward with actions to ensure the public is protected from unreasonable risks from chemicals in a way that is supported by science and the law.
 
Expanding Consideration of Exposure Pathways and Fenceline Community Exposure Screening Level Approach  

Under the previous administration, the first 10 risk evaluations did not assess air, water or disposal exposures to the general population because these exposure pathways were already regulated, or could be regulated, under other EPA-administered statutes such as the Clean Air Act, Safe Drinking Water Act, or Clean Water Act. The approach to exclude certain exposure pathways also resulted in a failure to consistently and comprehensively address potential exposures to potentially exposed or susceptible subpopulations, including fenceline communities (i.e., communities near industrial facilities).

In the original risk evaluation for 1,4-dioxane – and in a supplemental assessment – EPA did not evaluate certain exposure pathways or populations that could be considered potentially exposed or susceptible subpopulations. Thus, EPA currently intends to re-open and update the 1,4-dioxane risk evaluation to consider whether to include additional exposure pathways, like drinking water and ambient air, and conditions of use where 1,4-dioxane is generated as a byproduct that were excluded from the supplemental and final risk evaluations. The agency plans to take public comment on any potential revisions to the 1,4-dioxane risk evaluation before finalizing them.

For six of the first 10 chemicals, EPA plans to further examine whether the policy decision to exclude certain exposure pathways from the risk evaluations will lead to a failure to identify and protect fenceline communities. These six chemicals are methylene chloride, trichloroethylene, carbon tetrachloride, perchloroethylene, NMP, and 1-bromopropane. 

To determine if these six chemicals do present unreasonable risks to these communities, EPA is developing a screening-level approach to conduct ambient air and surface water fenceline assessments. This approach will use existing data and information to determine if there is the potential for unreasonable risk to fenceline communities associated with air and water exposures. 

If this approach yields information that there is no unreasonable risk to these communities, EPA intends to move forward to proposed risk management rulemakings. Alternatively, if the agency finds through the application of the screening-level approach that there may be unreasonable risk to these communities that cannot be addressed without supplementing the risk evaluation or through the risk management approaches the agency is already considering, EPA will conduct a more comprehensive exposure assessment of fenceline communities and supplement the risk evaluation for that chemical with the new information. 

Later this calendar year, EPA plans to make these screening approaches and methods, and their application to one or more chemicals, available for public comment and have them peer reviewed by the Scientific Advisory Committee on Chemicals. 

Use of Personal Protective Equipment

In the final risk evaluations for the first 10 chemicals, the previous administration generally assumed that workers were always provided, and used, personal protective equipment (PPE) appropriately. However, data on violations of PPE use suggest that assumptions that PPE is always provided to workers, and worn properly, are not justified. Continued use of this assumption could result in risk evaluations that underestimate the risk, and in turn, risk management rules may not provide the needed protections. 

EPA is therefore revisiting the assumption that PPE is always used in occupational settings when making risk determinations for a chemical. Instead, the agency plans to consider information on use of PPE, or other ways industry protects its workers, as a potential way to address unreasonable risk during the risk management process. 

The first 10 risk evaluations already include exposure analysis with and without PPE. Therefore, removing this assumption does not create need for new analysis. However, this shift could change some of the conclusions about risk on some conditions of use for six of the first 10 chemicals for which “no unreasonable risk” findings were made based on the use of PPE. Specifically, this shift could impact conclusions about risk for some conditions of use for methylene chloride, 1-bromopropane, HBCD, NMP, perchloroethylene, and 1,4-dioxane. 

Chemicals Moving to Risk Management

EPA has reviewed the risk evaluations issued for HBCD, PV29, and asbestos (part 1: chrysotile asbestos). EPA currently believes the risk evaluations are likely sufficient to inform the risk management approaches being considered and these approaches will be protective. Moving forward, EPA intends to reissue the risk determinations that amend the approach to PPE and include a whole chemical risk determination for these three chemicals. The agency is also working expeditiously on risk management, and believes the proposed rules for these three chemicals will likely be the first of the 10 to be ready for release. 

Whole Chemical Approach 

Under the previous administration, EPA made separate unreasonable risk determinations for every condition of use of a chemical. For the first 10 chemicals under TSCA and for any similar chemical that presents significant risks across many uses, EPA will continue to assess and analyze each conduction of use, but then the agency plans to make the determination of unreasonable risk just once for the whole chemical when it is clear the majority of the conditions of use warrant one determination. EPA intends to withdraw the previously issued orders for those conditions of use for which no unreasonable risk was found for all the first 10 risk evaluations. The agency then intends to issue revised unreasonable risk determinations for these chemicals as a “whole substance” and seek public comment on this approach. 

More information on TSCA risk evaluations can be found at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/chemicals-undergoing-risk-evaluation-under-tsca.

MIL OSI USA News