By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on September 24, 2021, that it is extending the submission deadline for manufacturers (including importers) of 50 chemicals to report data from certain unpublished health and safety studies. The deadline for the reporting rule was originally September 27, 2021, and EPA has extended the deadline until December 1, 2021, for 20 of the 50 chemicals and to January 25, 2022, for 30 of the 50 chemicals. The 50 chemicals include:

• Twenty chemicals designated by EPA as high-priority substances and currently undergoing risk evaluation under the Toxic Substances Control Act (TSCA). The deadline for manufacturers to submit studies on these chemicals will be December 1, 2021. EPA states that this deadline “ensures that health and safety studies will be received in time for use in risk evaluations on these chemical substances.”
   
• Thirty organohalogen flame retardants being evaluated for health risks by the Consumer Product Safety Commission (CPSC) under the Federal Hazardous Substances Act (FHSA). The deadline for manufacturers to submit studies on these chemicals will be January 25, 2022.

EPA will publish a notice in the Federal Register extending the deadline. A pre-publication version of the notice is available on EPA’s website. EPA has also posted a “historic” question and answer document about reporting under TSCA Section 8(d). Detailed information about the reporting rule is available in our June 29, 2021, memorandum, “Manufacturers and Importers of 20 High-Priority Chemicals and 30 Organohalogen Flame Retardants Must Submit Data to EPA.”

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By Lynn L. Bergeson and Carla N. Hutton
 
On December 21, 2020, the U.S. Environmental Protection Agency (EPA) announced that a report compiling the letter peer reviewers’ comments on the revised draft Toxic Substances Control Act (TSCA) risk evaluation of C.I. Pigment Violet 29 (PV29) is now available in Docket EPA-HQ-OPPT-2018-0604.  EPA states that it is in the process of reviewing the letter peer reviewers’ comments and will use the feedback received from the peer review and public comments to inform the final risk evaluation.
 
According to EPA, after it issued the draft risk evaluation in November 2018, it received additional data in response to test orders, as well as additional information voluntarily submitted by the sole U.S. manufacturer.  EPA states that these new data led it to revise its analytical approach for evaluating the potential exposure and health effects of PV29.  As a result of this updated analysis, the revised draft risk evaluation now shows unreasonable risk to workers for 11 out of 14 conditions of use.  Because these new data had a significant impact on EPA’s risk evaluation and ultimately the risk determinations, EPA provided an opportunity for the public to give input before issuing the final risk evaluation.
 
EPA notes that it also conducted a letter peer review of the revised draft risk evaluation using independent scientists, including one who has served as a member and several who have served as ad hoc peer reviewers for the TSCA Science Advisory Committee on Chemicals (SACC).  The peer review focused on charge questions supplied by EPA.  The report made available December 21, 2020, is the result of this letter peer review.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on October 29, 2020, that it is releasing a revised draft risk evaluation for C.I. Pigment Violet 29 (PV29) for public comment and peer review under the Toxic Substances Control Act (TSCA).  EPA states that after it issued a draft risk evaluation in November 2018, it received additional data on PV29 in response to test orders, as well as additional information voluntarily submitted by the sole U.S. manufacturer.  According to EPA, these new data led EPA to revise its analytical approach for evaluating the potential exposure and health effects of PV29.  EPA’s updated analysis, reflected in the revised draft risk evaluation, now shows unreasonable risk to workers for 11 out of 14 conditions of use.  EPA states that because the new data had a significant impact on its risk evaluation and ultimately the risk determinations, it is providing an opportunity for the public and independent scientific experts to give input before the risk evaluation is prepared in final.
 
EPA will publish a Federal Register notice on October 30, 2020, beginning a 30-day comment period.  During the public comment period, EPA states that it will also conduct a letter peer review of the revised draft risk evaluation using independent scientists, including one who has served as a member and several who have served as ad hoc peer reviewers for the TSCA Science Advisory Committee on Chemicals (SACC).  The peer review will focus on charge questions supplied by EPA, and EPA states that “the public is encouraged to focus their comments on those issues as well.”
 
EPA will use feedback received from the letter peer review and public comment process to inform the final risk evaluation.  EPA notes that the revised draft risk evaluation is not a final agency action and represents its current review of the scientific information on PV29.  As with any chemical product, EPA “strongly recommends that users carefully follow all instructions on the product’s label/safety data sheet.”

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By Lynn L. Bergeson and Carla N. Hutton
 
On August 26, 2020, the U.S. Environmental Protection Agency (EPA) released an interim final list of businesses subject to fees for the 20 chemicals designated as high priority for risk evaluation under the Toxic Substances Control Act (TSCA).  EPA notes that the interim list is an updated version of the preliminary list released in January 2020.  According to EPA, making the interim final list available now gives businesses and other stakeholders an opportunity to review the list for accuracy and provides time for businesses to engage in initial outreach regarding the formation of consortia to share in fee payments.  As reported in our January 29, 2020, blog item, EPA published a Federal Register notice on January 27, 2020, identifying the preliminary lists of manufacturers (including importers) of the 20 chemical substances that EPA designated as high-priority substances for risk evaluation and for which fees will be charged.  85 Fed. Reg. 4661.  During the comment period, manufacturers (including importers) were required to self-identify as manufacturers of a high-priority substance irrespective of whether they are included on the preliminary lists identified by EPA.  EPA used this information, along with feedback received during the public comment period, to develop the interim final list.
 
EPA states that it will publish the final list of businesses subject to fees for the 20 high-priority chemicals concurrently with the release of the final scope documents for these chemicals.  Companies on the final list are subject to a portion of the TSCA fee for these risk evaluations and have 60 days to notify EPA of the formation of consortia.  According to EPA, it plans to begin invoicing for the fees after those 60 days have passed.  Due to the public health emergency, EPA states that it is exploring options for payment flexibilities.  Information on forming a consortium is available in our March 2, 2020, memorandum, “The Essential Value of Forming TSCA Consortia.”

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By Lynn L. Bergeson and Carla N. Hutton
 
On April 17, 2020, the U.S. Environmental Protection Agency (EPA) released the second set of draft scope documents for the seven remaining chemicals designated as high-priority substances for risk evaluation under the Toxic Substances Control Act (TSCA).  As reported in our December 20, 2019, memorandum, EPA designated these chemicals as a high priority for risk evaluation in December 2019.  According to EPA, seeking public input on the conditions of use to be included in the risk evaluations for these chemicals is the next step in the process outlined in TSCA.  EPA states that “[‌i]t is important to note that being designated as a high-priority chemical does not mean that a chemical is high risk.”
 
EPA is releasing draft scope documents for the following chemicals:

• Butyl benzyl phthalate (BBP) (1,2-benzenedicarboxylic acid, 1-butyl 2-(phenylmethyl) ester);
• Dibutyl phthalate (DBP) (1,2-benzenedicarboxylic acid, 1,2-dibutyl ester);
• Dicyclohexyl phthalate (1,2-benzenedicarboxylic acid, 1,2-dicyclohexyl ester);
• Di-ethylhexyl phthalate (DEHP) (1,2-benzenedicarboxylic acid, 1,2-bis(2-ethylhexyl) ester);
• Di-isobutyl phthalate (DIBP) (1,2-benzenedicarboxylic acid, 1,2-bis(2-methylpropyl) ester);
• Formaldehyde; and
• Phthalic anhydride (1,3-isobenzofurandione).

 
EPA will publish a Federal Register notice announcing the availability of the draft scope documents for public comment.  Publication of the notice will begin a 45-day comment period.  EPA states that it will use feedback received from the public comment process to inform the final scope documents.  More information on the second batch of draft scope documents will be available in a forthcoming memorandum that will be posted on our website.  Our April 7, 2020, memorandum, “EPA Seeks Public Comment on First Batch of Draft Scope Documents,” offers an overview of the draft scope documents on the other 13 of the 20 chemicals undergoing risk evaluation, as well as an insightful commentary.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) will hold a call on April 16, 2020, from 1:00 p.m. to 2:00 p.m. (EDT) on its recently announced plan to reduce burden for certain stakeholders subject to the Toxic Substances Control Act (TSCA) fees rule requirements for EPA-initiated risk evaluations.  The call will cover:

• TSCA fees rule requirements and processes associated with EPA-initiated risk evaluations;
   
• EPA’s March 25, 2020, rulemaking announcement and “No Action Assurance” and the implications for certain manufacturers who:  (1) import a high-priority chemical in an article; (2) produce a high-priority chemical as a byproduct; or (3) produce or import a high-priority chemical as an impurity; and
   
• Reporting obligations during the current comment period for the preliminary lists of fee payers, closing May 27, 2020.

EPA asks stakeholders to submit questions by April 14, 2020, to Ben Dyson, .(JavaScript must be enabled to view this email address), and EPA will address them during the call.  Additional questions from participants will be answered during the call as time permits.  Registration is now open.

Resource

Our March 4, 2020, memorandum, “EPA Plans to Provide Additional Clarification on Self-Identifying as a Manufacturer or Importer of a High-Priority Chemical,” suggests that industry stakeholders that believe they may be impacted by the January 27 notice may wish to consider suspending ongoing internal deliberations on self-reporting obligations until EPA provides additional guidance.
 
Information on forming a consortium is available in our March 2, 2020, memorandum, “The Essential Value of Forming TSCA Consortia.”
 
More information on the 20 substances designated as high-priority substances is available in our December 20, 2019, memorandum, “Final List of High-Priority Chemicals Will Be Next to Undergo Risk Evaluation under TSCA.”
 
More information on the final TSCA fees rule is available in our September 28, 2018, memorandum, “EPA Issues Final TSCA Fees Rule.”

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