By Lorrie Ritter, Sr. Chemical Regulatory Compliance Specialist
Late June 2021, 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 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.
The first 10 chemicals for which risk evaluations were released under the previous administration are:
|Cyclic aliphatic bromide cluster (HBCD)||25637‐99‐ 4; 3194‐55‐6; 3194‐57‐8|
|N-methyl pyrrolidone (NMP)||872-50-4|
|Pigment violet||29 81-33-4|
|Tetrachloroethylene, also known as perchloroethylene||127-18-4|
What is Changing?
Expanding Exposure Pathways
This new approach will consider exposure pathways and fenceline communities meaning communities near industrial facilities. The EPA plans to invite public comment on any potential revisions to the 1,4-dioxane risk evaluation before finalizing them partly because the original risk evaluation and supplemental assessment for 1,4-dioxane did not evaluate pathways the EPA regulates under other statutes such as the Clean Air Act, Safe Drinking water Act or the Clean Air Act. So, they intend to re-open the risk evaluation for this substance to consider whether to include additional exposure pathways, such as drinking water and ambient air, as well as the conditions of use where this substance is generated as a byproduct.
For 6 of the 10 chemicals, the 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 6 chemicals are:
- methylene chloride
- carbon tetrachloride
If the EPA determines that there is no unreasonable risk to these communities, it intends to move forward to proposed risk management rulemakings. In the alternative, the EPA will conduct a more comprehensive exposure assessment of communities near industrial communities and will supplement the risk evaluation for the chemical in question with that updated information.
Later this year, the EPA plans to make these screening approaches and methods, as well as their application to one or more chemicals, available for public comment and have them peer-reviewed by the Scientific Advisory Committee on Chemicals.
Personal Protective Equipment
The EPA is trying to ensure that Personal Protective Equipment is provided to workers and worn properly in an effort to protect workers and will address unreasonable risks during the risk management process. The first 10 risk evaluations, which include exposure analysis with and without PPE, do not need additional analysis. This policy shift could change some of the conclusions about the risk for 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 and impact conclusions about the risk for some conditions of use for methylene chloride, 1-bromopropane, HBCD, NMP, perchloroethylene, and 1,4-dioxane.
Chemicals Moving to Risk Management
The EPA has reviewed the risk evaluations issued for HBCD, PV29, and asbestos (part 1: chrysotile asbestos). Based on this review, the agency believes that the risk evaluations are sufficient to inform the risk management approaches being considered and that these approaches will be protective. Moving forward, the agency intends to reissue the risk determinations that amend the approach to PPE and include a whole chemical risk determination for these three chemicals. In addition, the EPA is 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
EPA will continue to assess and analyze each condition of use, but then the agency plans to make the determination of unreasonable risk just once for the whole chemical as opposed to unreasonable risk determination for every condition of use of a chemical. The agency then intends to issue revised unreasonable risk determinations for these first ten chemicals as a “whole substance” and seek public comment on this approach.
Further information can be found at https://www.epa.gov/.
GSM has a team of Regulatory Compliance Specialists trained in monitoring all governmental changes impacting the Safety Data Sheets and labels for our customers. Contact us to assist businesses that manufacture (including import) or sell any articles containing any of the 10 chemicals evaluated under the first 10 risk evaluations.