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By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on May 28, 2020, extending the comment and reporting period on the preliminary lists of manufacturers (including importers) subject to fees associated with EPA-initiated risk evaluations under the Toxic Substances Control Act (TSCA).  85 Fed. Reg. 32036.  The new due date is June 15, 2020.  EPA states that it is extending the comment period in response to stakeholder feedback and to allow companies additional time to report, or self-identify, as to whether they are a manufacturer subject to fees for the next 20 TSCA risk evaluations.  EPA intends to issue final scope documents for the next 20 risk evaluations in summer 2020 and will publish the final list of fee payers no later than concurrently with the final scope documents.

EPA held a conference call on TSCA fees on April 16, 2020, and posted the slides and transcript for the call.  EPA’s web page on TSCA fees for EPA-initiated risk evaluations includes frequently asked questions.  Our March 2, 2020, memorandum, “The Essential Value of Forming TSCA Consortia,” provides information on forming a consortium.  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.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
On April 16, 2020, the U.S. Environmental Protection Agency (EPA) hosted a call on its recently announced plan to reduce the burden for certain stakeholders subject to the Toxic Substances Control Act (TSCA) fees rule requirements for EPA-initiated risk evaluations.  The call covered:

  • How EPA’s plan to initiate a rulemaking to consider proposing exemptions to the current rule’s requirements impacts manufacturers and other businesses;
     
  • What the “No Action Assurance” means for importers of articles and producers of byproducts and impurities; and
     
  • Reporting obligations during the current comment period, which will close May 27, 2020.

EPA announced on March 25, 2020, that plans to initiate a new rulemaking process to consider proposing exemptions to the current rule’s self-identification requirements associated with EPA-initiated risk evaluations for manufacturers that:

  • Import the chemical substance in an article;
     
  • Produce the chemical substance as a byproduct; or
     
  • Produce or import the chemical substance as an impurity.

During the call, EPA stated that it expects to begin rulemaking in the short term with the goal of issuing a final rule by October 1, 2021.  As a bridge to the final rule, EPA issued a “No Action Assurance” for these three categories of manufacturers.  EPA will not pursue enforcement action against entities in these manufacturer categories for failure to self-identify under 40 C.F.R. Section 700.45(b)(5).
 
EPA has posted frequently asked questions (FAQ) about TSCA fees for EPA-initiated risk evaluations.  The current FAQs include:

March 2020 Rulemaking Announcement and No Action Assurance

  1. Why is EPA announcing its intention to propose exemptions to the TSCA fees rule?
  2. What is the expected timing for this rulemaking?
  3. Is EPA considering any other changes to the TSCA fees rule as part of this rulemaking?
  4. What does the “No Action Assurance” mean?
  5. Do entities in the three categories in the planned regulatory change still have to self-identify during the comment period closing on May 27, 2020?
  6. Are entities in the three categories impacted by the planned regulatory change still responsible for paying a portion of the risk evaluation fee?
  7. What should I do if I’ve already self-identified as a manufacturer, but fall into one of the three categories in the planned regulatory change?
  8. What should I do if I’ve been identified on a Preliminary List, but fall into one of the three categories in the planned regulatory change?
  9. What should I do if I fall into one of the three categories in the planned regulatory change, but have NOT yet self-identified and was NOT identified on a Preliminary List?
  10. What constitutes an “article” for purposes of the planned regulatory change?
  11. What constitutes a “byproduct” for purposes of the planned regulatory change?
  12. What constitutes an “impurity” for purposes of the planned regulatory change?

Reporting for TSCA Fees

  1. What do I have to do if my entity was erroneously on a Preliminary List?

EPA has posted the slides for the call.  EPA states that it will post a transcript of the call on its website.

Resources

Our March 4, 2020, memorandum, “EPA Plans to Provide Additional Clarification on Self-Identifying as a Manufacturer or Importer of a High-Priority Chemical,” suggested 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.”


 

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.”


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on March 25, 2020, that it will consider a proposed rule that would look at potential exemptions to the Toxic Substances Control Act (TSCA) fees rule in response to stakeholder concerns about implementation challenges.  EPA states that by considering a proposal to narrow the broad scope of the current requirements, it “could significantly reduce burden on potentially thousands of businesses across the country while maintaining the ability to successfully implement the Lautenberg Act amendments” to TSCA to protect human health and the environment.  According to EPA, it plans to initiate a new rulemaking process to consider proposing exemptions to the current rule’s self-identification requirements associated with EPA-initiated risk evaluations for manufacturers that:

  • Import the chemical substance in an article;
  • Produce the chemical substance as a byproduct; or
  • Produce or import the chemical substance as an impurity.

EPA states that it may also consider proposing other changes to the rule during this process consistent with TSCA’s requirement to reevaluate the fees rule every three years.  EPA notes that it believes that considering exempting certain entities from self-identification requirements will not impede the ability to collect fully the necessary fees and will still allow it to achieve the ultimate objective of the TSCA fees rule and the statute -- “to defray a portion of EPA’s TSCA implementation costs.”  EPA intends to issue proposed amendments to the current fees rule later in 2020, with the goal of promulgating the amendments in 2021.

EPA states that additionally, “in light of the extremely unusual circumstances of this situation and the undue hardship imposed on certain businesses who would be required to collect and report information” under the TSCA fees rule, EPA issued a “no action assurance” for the three categories of manufacturers at this time.  More specifically, EPA “will exercise its enforcement discretion regarding the self-identification requirement for the three categories of manufacturers” for which EPA intends to propose an exemption.

EPA suggests that businesses that are erroneously on the preliminary lists of fee payers or fall into one of the three categories discussed above should see its frequently asked questions (FAQ) for more information about how to certify as such to EPA and to avoid fee obligations.  EPA posted more information on its announcement, as well as a copy of the no-action assurance, on its website.  More information is available in our March 9, 2020, blog item, “EPA Extends Deadline to Self-Identify as a Manufacturer or Importer of a High-Priority Chemical to May 27.”


 

By Lynn L. Bergeson and Carla N. Hutton

On March 9, 2020, the U.S. Environmental Protection Agency (EPA) announced that it has extended the deadline to self-identify as a manufacturer or importer of a high-priority chemical to May 27, 2020.  EPA states that it is working to address issues identified with implementation of the Toxic Substances Control Act (TSCA) Fees Rule and EPA-initiated risk evaluations.  EPA “is actively seeking ways to address the many implementation impracticalities that have been brought to our attention and to reduce concerns by affected entities.”  During the extended comment period extension, EPA “will continue to receive input from the regulated community and analyze options to address some of the implementation challenges with the final rule and reduce stakeholder concerns.”  EPA will publish a Federal Register notice announcing the extension of the comment deadline.  A pre-publication version of the notice is available.

Background

As reported in our February 26, 2020, memorandum, on February 24, 2020, EPA hosted a conference call to review certain provisions of the final rule on fees for the administration of TSCA, particularly those related to EPA-initiated risk evaluations.  EPA published a Federal Register notice on January 27, 2020, identifying the preliminary lists of manufacturers (including importers) of the 20 high-priority chemical substances for risk evaluation for which fees will be charged.  85 Fed. Reg. 4661.  During the comment period, manufacturers (including importers) are required to self-identify as manufacturers of a high-priority substance irrespective of whether they are included on the preliminary lists identified by EPA.

Resources

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.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
The Office of Inspector General (OIG) for the U.S. Environmental Protection Agency (EPA) announced on February 27, 2020, that it plans to begin its audit of the EPA’s Toxic Substances Control Act (TSCA) Service Fee Fund financial statements for the period from inception, June 22, 2016, to September 30, 2018.  According to the Project Notification, the audit objectives are to determine whether:

  1. The financial statements are fairly presented in all material respects in accordance with generally accepted accounting principles;
  2. EPA’s internal control structure over financial reporting related to the financial statements is in place and provides reasonable assurance that:
    • Financial transactions are executed in compliance with applicable laws, regulations, contracts, and grant agreements;
    • Assets are safeguarded against loss from unauthorized acquisition, use, or disposition; and
    • Transactions are properly recorded, processed, and summarized to permit the preparation of reliable financial statements;
  3. EPA has complied with laws and regulations that would have a direct and material effect on the financial statements; and
  4. The information and manner of presentation contained in the Management’s Discussion and Analysis, and any other accompanying information, are materially consistent with the information contained in the principal statements.

OIG states that the Frank R. Lautenberg Chemical Safety for the 21st Century Act requires that the annual audit of the financial statements also include:

  1. An analysis of the fees collected and amounts disbursed;
  2. The reasonableness of the fees in place as of the date of the audit to meet current and projected costs of administering the provisions of the law; and
  3. The number of requests for a risk evaluation made by manufacturers.

OIG notes that since fees have not been collected, however, it does not anticipate work in this area for the financial statements for the period from inception, June 22, 2016, to September 30, 2018.

 

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Tags: Fees, Audit, OIG

 

By Lynn L. Bergeson and Carla N. Hutton
 

The U.S. Environmental Protection Agency (EPA) will host a conference call on February 24, 2020, from 12:30 to 1:00 p.m. (EST) to review certain provisions of the final rule on fees for the administration of the Toxic Substances Control Act (TSCA).  In light of the recent publication of the preliminary list of manufacturers/importers subject to risk evaluation fees, as reported in our January 29, 2020, blog item, EPA states that it will give a brief overview of the fees associated with an EPA-initiated risk evaluation, the entities subject to fees, requirements for self-identification, and how fees will be divided among those identified on final lists.  The publication of the lists has inspired considerable confusion and the call is intended to address as many as possible of them.  Questions can be submitted in advance to Ryan Schmit at .(JavaScript must be enabled to view this email address).  Additional questions will be answered as time permits.  To attend, call the following number and enter the conference ID:

Call-in Number: (877) 317-0679
Conference ID: 3372249

The preliminary list of manufacturers/importers subject to risk evaluation fees is available in Docket EPA-HQ-OPPT-2019-0677.  Reference 9 from the final rule on fees, TSCA Fee Reporting Notice (Sept. 2018), is available in the docket for the final rule at https://www.regulations.gov/document?D=EPA-HQ-OPPT-2016-0401-0079.  More information about TSCA fees is available on EPA’s website at http://www.epa.gov/TSCA-fees.


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) is scheduled to publish 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.  Publication of the Federal Register notice will begin a 60-day comment period during which manufacturers (including importers) will be required to self-identify as a manufacturer of a high-priority substance irrespective of whether they are included on the preliminary lists identified by EPA.  EPA states that where appropriate, entities may also avoid or reduce fee obligations by making certain certifications consistent with the final rule on fees for the administration of the Toxic Substances Control Act (TSCA).  During the 60-day comment period, the public will have the opportunity to correct errors or provide comments on the preliminary lists.  According to the notice, EPA expects to publish final lists of manufacturers (including importers) subject to fees no later than concurrently with the publication of the final scope document for risk evaluations of the 20 high-priority substances.  Manufacturers (including importers) identified on the final lists will be subject to applicable fees.

Once the Federal Register notice is published, the preliminary lists will be available in docket number EPA-HQ-OPPT-2019-0677 at http://www.regulations.gov and on EPA’s website at http://www.epa.gov/TSCA-fees.  EPA states that it developed each preliminary list “using the most up-to-date information available, including information submitted to the Agency (e.g., information submitted under TSCA section 8(a) (including the Chemical Data Reporting (CDR) Rule) and section 8(b), and to the Toxics Release Inventory (TRI)).”  According to the notice, EPA considered using other sources of information, such as publicly available information or information submitted to other agencies to which EPA has access, but EPA “concluded that data quality limitations would create more false positives than appropriate additions to the lists.”  Additionally, EPA notes that it believes the Self-Identification process, established by 40 C.F.R. Section 700.45(b)(5), will be sufficient to identify additional manufacturers (including importers), as appropriate.  To include the two most recent CDR reporting cycle data (collected every four years) and to account for annual or other typical fluctuations in manufacturing (including import), EPA states that it used six years of data submitted or available to it under CDR and TRI to create the preliminary lists (2012-2018).

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.”

See Also: "Are You Potentially Responsible for TSCA Fees? EPA Issues Preliminary Lists of Companies Responsible for TSCA Risk Evaluation Fees" episode of All Things Chemical™ podcast


 

By Lynn L. Bergeson and Carla N. Hutton
 
On December 19, 2019, from 2:00 p.m. to 2:30 p.m. (EST), the U.S. Environmental Protection Agency (EPA) will host a conference call to review certain provisions of the final rule on fees for the administration of the Toxic Substances Control Act (TSCA).  EPA states that it will provide a brief overview of the fees associated with an EPA-initiated risk evaluation, the creation of the preliminary list that identifies manufacturers and importers subject to fees, and how it divides fees among the identified businesses.  Questions should be submitted in advance to .(JavaScript must be enabled to view this email address).   The call-in number is (877) 317-0679, and the conference code is 1480769.  More information on EPA’s 2018 final rule is available in our September 28, 2018, memorandum, “EPA Issues Final TSCA Fees Rule.”

Tags: CBI, Fees

 

By Lynn L. Bergeson and Margaret R. Graham

On October 17, 2018, the U.S. Environmental Protection Agency (EPA) issued its final fees rule under the Toxic Substances Control Act (TSCA) in the Federal Register.  83 Fed. Reg. 52694.  The final rule largely tracks the proposed rule.  EPA is establishing fees applicable to any person required to submit information to EPA; or a notice, including an exemption or other information, to be reviewed by EPA; or who manufactures (including imports) a chemical substance that is the subject of a risk evaluation.  This final rulemaking describes the final TSCA fees and fee categories for fiscal years 2019, 2020, and 2021, and explains the methodology by which the final TSCA fees were determined.  It identifies some factors and considerations for determining fees for subsequent fiscal years; and includes amendments to existing fee regulations governing the review of premanufacture notices, exemption applications and notices, and significant new use notices. As required in TSCA, EPA is also establishing standards for determining which persons qualify as “small business concerns” and thus would be subject to lower fee payments.  Small businesses will be eligible to receive a substantial discount of approximately 80 percent on their fees.  EPA will host a series of webinars focusing on making TSCA submissions and paying fees under the final rule.  The first webinar was held on October 10, 2018.  The other two webinars will be held on October 24, 2018, from 1:00 p.m. to 2:30 p.m. (EDT) and on November 7, 2018, from 1:00 p.m. to 2:30 p.m. (EDT).  Our memorandum provides an overview of the final rule with specific information about final fee amounts and timing and a commentary.  The final rule is effective on October 18, 2018.


 
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