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TSCA Update: Revised Chemical Risk Determinations

Posted on 1/31/2023 by Roger Marks and Anthony Cardno, CHMM

Update 01/16/23

US EPA has published its final revised TSCA risk determination for trichloroethylene (TCE), finding that it poses an unreasonable risk of injury to human health.  

The agency announced availability of the final revised risk determination on January 9, 2023



Update 12/27/22

US EPA's final revised TSCA risk determination for carbon tetrachloride (CASRN 56-23-5) is now available. The revised determination finds that the chemical—also known as carbon tet, tetrachloromethane, Halon-104, or Refrigerant-10 in some industries—presents an unreasonable risk to health. 

We've added an update for carbon tetrachloride to the list below (Jump to the list).


Update 12/19/22

US EPA released revised chemical risk determinations, required under TSCA, for four chemical substances recently:     

  • Methylene Chloride (MCL)
  • Perchloroethylene (PCE)
  • 1-Bromopropane (1-BP)
  • n-Methylpyrrolidone (NMP)

These revised risk determinations reflect EPA’s “whole chemical approach” to evaluating the risks that TSCA inventory chemicals pose to workers, public health, and the environment.

Updates for MCL, PCE, 1-BP, and NMP—including links to the revised risk determination announcements—have been added to the list below (Jump to the list).


Update 09/02/22

EPA’s final TSCA risk determination for Color Index Pigment Violet 29 (PV29) was published to the Federal Register on September 6. 

EPA finds that PV29—as a whole chemical substance—presents an unreasonable risk to health. The final revised risk determination will be followed by a rulemaking to impose restrictions and/or management standards that address the risks, as required by TSCA Section 6(a).

EPA expects to propose management standards for several TSCA inventory chemicals throughout 2023. We have updated the entry for PV29 on the list of TSCA risk determination documents in the post below (Jump to the list).

TSCA Update: Revised Chemical Risk Determinations


Update 08/29/22

EPA released a draft of a revised TSCA risk determination for carbon tetrachloride and will accept public comments until September 28, 2022. The draft revision finds that carbon tetrachloride, as a whole chemical substance, poses an unreasonable risk to health when evaluated under its conditions of use.

We’ve added carbon tetrachloride to the list of updated TSCA risk evaluation documents in the post below (View the list).


Original Article (Posted 07/08/22)

EPA’s New Approach to TSCA Risk Evaluations

EPA is re-evaluating chemical risk assessments completed during the previous administration to, in their words, ensure they are based on sound science and law. Earlier risk determinations failed to sufficiently address risks to workers and the environment, EPA now says.

The updated risk determinations reflect EPA’s “whole chemical approach” to TSCA risk evaluations. EPA announced the major shift in its approach to risk evaluations about one year ago, in June 2021.

Previously, EPA made separate risk determinations for each condition of use of a chemical substance. Under the “whole chemical” approach, EPA considers all conditions of use at the same time, regardless of whether a specific use is regulated (or could be) under other environmental statutes (e.g., the Clean Air Act).

EPA also stresses that previously completed risk determinations wrongly assumed that employees who work with chemicals always wear appropriate personal protective equipment (PPE). That’s not true, EPA now believes. Some employers may fail to provide needed PPE to workers or fail to train personnel on PPE maintenance and use. Even when PPE is made available, it may not be adequate or used properly.

In addition, OSHA developed many of the permissible exposure limits (PELs) for hazardous chemicals decades ago. These PELs are now, in OSHA’s own words, “outdated and inadequate for ensuring protection of worker health.” Now when evaluating the risks of chemicals to workers, EPA does not assume that workers will use appropriate PPE.

EPA published a Final Rule on July 5 to align the TSCA regulations for “significant new uses” of chemical substances with OSHA’s Hazard Communication Standard (HCS) and make other revisions.

Revised Risk Determinations 

When finalized, these revised determinations will supersede any previous, condition of use-specific determinations of no unreasonable risk.


CI Pigment Violet 29 (PV 29)

Draft—Revised Risk Determination (03/07/22)
Final Revision to the Risk Determination (09/06/22) 
Unreasonable Risk? Yes—Health

Used to color materials and as an intermediate for high performance pigments, Color Index Pigment Violet 29 (PV 29) is used in car paints and coatings, commercial printing, and consumer watercolor paints.

The revised risk determination supersedes EPA's earlier use-specific risk findings for PV29. .

 

Cyclic Aliphatic Bromide Cluster (HBCD)

Final Revision to the Risk Determination (06/29/22)
Unreasonable risk? Yes—Health and Environment.

Cyclic Aliphatic Bromide Cluster chemicals, namely hexabromocyclododecane or HBCD, are a class of flame retardants used in building materials, recycled plastics, and car parts. HBCD has been mostly substituted out of use in the US.

EPA’s previous chemical risk evaluation for HBCD, completed in September 2020, found unreasonable risk for six of the twelve conditions of use considered.

 

Perchloroethylene (PCE)

Draft—Revised Risk Determination (06/30/22)
Final Revision to the Risk Determination (12/14/22) 
Unreasonable risk? Yes—Health.

PCE is a colorless liquid used mostly to produce fluorinated compounds for industrial gas manufacturing (e.g., HFCs and HCFCs). It’s also found in adhesives, brake cleaners, aerosol lubricants, sealants, and polishes.

Update 12/19/22: EPA finds that PCE, as a whole chemical substance, presents an unreasonable risk of injury to health. The revised risk determination supersedes EPA’s earlier finding, completed in December 2020, which found unreasonable risk in 59 out of 61 conditions of use evaluated.  



n-methylpyrrolidone (NMP)

Draft—Revised Risk Determination (07/01/22)
Final Revision to the Risk Determination (12/19/22) 
Unreasonable risk? Yes—Health.

NMP is used in chemical manufacturing, petrochemical processing, and the electronics industry as a substitute for halogenated solvents. It is also used in the manufacturing of lithium batteries. EPA’s earlier risk determination found no unreasonable risk to the environment for NMP, but found unreasonable risk to consumers, workers, and occupational non-users under some conditions of use. 

Update 12/19/22: The final revised risk determination, EPA found that NMP poses an unreasonable risk of injury to health. The revised determination supersedes the "no unreasonable risk" determination issued in December 2020. 

 

Methylene Chloride (MCL)

Draft—Revised Risk Determination (07/05/22)
Final Revision to the Risk Determination (11/10/22) 
Unreasonable risk? Yes—Health.

Following the earlier risk evaluation that found unreasonable risk, US EPA finalized a rule to prohibit the manufacture (including import), processing, and distribution in commerce of methylene chloride for consumer paint and coating removal.

Update 12/19/22: In the revised risk determination for MCL, EPA finds that the chemical presents an unreasonable risk of injury to health. EPA lists many "conditions of use" that drive this unreasonable risk, including domestic manufacturing and import, processing, and re-packaging, as well as use in solvents, adhesives, paints and coatings, and more. 

Update 05/05/23: Following completion of the chemical risk evaluation for methylene chloride, EPA proposed extensive prohibitions and restrictions under TSCA Section 6 for the manufacture, processing, distribution, and use of the substance on May 3. 



Trichloroethylene (TCE)

Draft—Revised Risk Determination (07/07/22)
Final Revision to the Risk Determination (01/09/23) 
Unreasonable risk? Yes—Health.

The initial risk determination for TCE, released in November 2020, found unreasonable risk to workers, occupational non-users, consumers, and bystanders in 52 out of 54 use cases examined.

On January 9, 2023, US EPA released a final revised risk determination that fines TCE poses an unreasonable risk of injury to health as "a whole chemical substance." 



1-Bromopropane (1-BP)

Draft—Revised Risk Determination (07/20/22)
Final Revision to the Risk Determination (12/19/22) 
Unreasonable risk? Yes—Health.

1-BP is commonly used as a solvent in vapor degreasing, dry cleaning, sealants, adhesives, and other similar activities. Use of 1-BP in the United States increased after US EPA approved it as a less-harmful replacement for ozone depleting substances (e.g., tetrachloroethylene) in 2007.

1-BP was added to the list of Clean Air Act Hazardous Air Pollutants (HAPs) in 2020.

Update 12/19/22: The revised risk determination finds that 1-BP, as a whole chemical substance, presents an unreasonable risk to health when evaluated under its conditions of use. The revised risk determination supersedes the “no unreasonable risk” determination announced in August 2020.

 

Carbon Tetrachloride

Draft—Revised Risk Determination (08/29/22)
Final Revision to the Risk Determination (12/27/22) 
Unreasonable risk? Yes—Health.

Carbon Tetrachloride (CASRN 56-23-5) is known by different names in different industries—carbon tet, tetrachloromethane, Halon-104, or Refrigerant-10, for example. The chemical is a clear, sweet-smelling liquid used in refrigerants, aerosol propellants, degreasers, spot remover products, fire extinguishers, and insect fumigants. It was also used as a pesticide until 1986.

Update 12/27/22: The final revised risk determination from US EPA finds that carbon tetrachloride, as a whole chemical substance, poses an unreasonable risk of injury to health. The revised determination supersedes the use-specific determinations finalized in 2020.


New TSCA Management Standards Planned for 2023

EPA has now revised the previously-completed risk determinations for eight of the first ten chemical substances selected in 2016 to undergo the TSCA risk evaluation process.

Now that EPA has re-evaluated the risks posed by these chemicals, the next steps are to review public comments, finalize the revised determinations, and create management standards to address unreasonable risks under TSCA Section 6(a).

Section 6 of TSCA authorizes EPA to prohibit or limit the manufacture, processing, distribution-in-commerce, use, and/or disposal of chemicals that pose an unreasonable risk to health or the environment.

EPA currently plans to propose new TSCA management standards for many chemicals throughout 2023—including methylene chloride, 1-bromopropane, TCE, PCE, carbon tetrachloride, and others—according to the latest Unified Agenda of Regulatory and De-regulatory Actions. 

EPA proposed TSCA 6(a) management standards for chrysotile asbestos earlier this year.

Asbestos (Part II) Scope Document Available

EPA released a scope document for Part 2 of its asbestos risk evaluation on June 29, 2022.

Part 1 of the risk evaluation addressed chrysotile asbestos (the most common type of asbestos). Part 2 will address other types of asbestos fibers, asbestos-containing talc, legacy uses, and associated disposal—all of which was excluded from Part 1.

1,4-dioxane 

The first risk determination for 1,4-dioxane, primarily used as a solvent, was one of three released during the final month of the previous administration. It found that 1,4-dioxane posed unreasonable risks to workers under thirteen conditions of use. No unreasonable risk was found to the environment, consumers, bystanders, or the general population. 

It is likely that EPA will re-evaluate the risks using the "whole chemical" approach they've used with all other recent revisions to TSCA risk determinations. . 

TSCA Regulations Online Course

Be confident you know how the "Lautenberg Law" and EPA's ongoing chemical risk evaluations will impact your responsibilities for chemical management, inventory reporting, and recordkeeping under TSCA.

The TSCA Regulations Online Course covers what professionals in the chemical manufacturing, import/export, storage, and processing fields must know to achieve and maintain TSCA compliance. 

Tags: chemicals, Lautenberg Law, TSCA

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