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Lion News July 2022

TSCA Update: Revised Chemical Risk Determinations

Posted on September 02, 2022 by Roger Marks and Anthony Cardno, CHMM

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’ve updated the entry for PV29 on the list of updated TSCA risk evaluation documents in the post below (View the list).

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.

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 Drafted

If finalized, these revised determinations will supersede the 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.

In 2021, EPA finalized its first risk evaluation for PV29, finding that the chemical posed unreasonable risk to workers in ten out of fourteen conditions of used evaluated.

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)
Comments closed 08/01/22.
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.

EPA’s earlier risk determination was completed in December 2020 and found that PCE posed “unreasonable risk” in 59 out of 61 conditions of use evaluated.  

n-methylpyrrolidone (NMP)
Draft—Revised Risk Determination (07/01/22)
Comments closed 08/01/22
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. 

Methylene Chloride (MCL)
Draft—Revised Risk Determination (07/05/22)
Comments closed 08/04/22
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.

Trichloroethylene (TCE)
Draft—Revised Risk Determination (07/07/22)
Comments closed 08/08/22
Unreasonable risk? Yes—Health.

The previous 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.

1-Bromopropane (1-BP)
Draft—Revised Risk Determination (07/20/22)
Comments closed 08/19
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. The original risk evaluation for 1-BP, completed in August 2020, found unreasonable risk to health for 16 out of 25 conditions of use considered.

Carbon Tetrachloride
Draft—Revised Risk Determination (08/29/22)
Comments due by 09/28/22
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. It’s 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.

If finalized, the revised risk determination would supersede the use-specific determinations made in 2020. At that time, EPA found that carbon tetrachloride posed an unreasonable risk to health for 13 of the 15 conditions of use evaluated.

New TSCA Management Standards Planned for 2023

EPA has now revised the previously-completed risk determinations for nine 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.

After completing Part 1 of the risk evaluation, EPA proposed new restrictions for chrysotile asbestos to address the unreasonable risks. The comment period for the proposed rule ends on July 13, 2022.

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.




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