Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C. law firm providing chemical and chemical product stakeholders unparalleled experience, judgment, and excellence in matters relating to TSCA, and other global chemical management programs.

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.


 

By Lynn L. Bergeson and Margaret R. Graham

On September 27, 2018, the U.S. Environmental Protection Agency (EPA) issued the user fees final rule for the administration of the Toxic Substances Control Act (TSCA), the fourth and remaining framework rule to be issued in final under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg).

This final rule, that amends 40 C.F.R. Parts 700, 720, 723, 725, 790, and 791, “describes the final TSCA fees and fee categories for fiscal years 2019, 2020, and 2021”; “explains the methodology by which the final TSCA fees were determined”; “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.”   The final rule has not been published yet in the Federal Register so an effective date is not yet available; a pre-publication version is available here.

Specifically, EPA is establishing fees applicable to any person required to submit information to EPA under TSCA Section 4; or a notice, including an exemption or other information, to be reviewed by EPA under TSCA Section 5; or who manufactures (including imports) a chemical substance that is the subject of a risk evaluation under TSCA Section 6(b).  EPA is also establishing standards for determining which persons qualify as "small business concerns" and thus would be subject to lower fee payments.  

In the press release announcing the rule, EPA Acting Administrator Andrew Wheeler states that this rule will “provide resources needed to support the valuable work EPA does to review chemicals for safety, manage risk as required, and make chemical information available as appropriate.”  During fiscal years 2019-2021, EPA states it will “work to track costs and will use that information to adjust future fees, if appropriate.”

EPA also announced that it will be hosting a series of webinars focusing on making TSCA submissions and paying fees under the final rule.  The webinars are scheduled for October 10, 2018, from 1:00 p.m. - 2:30 p.m. (EST); October 24, 2018, from 1:00 p.m. - 2:30 p.m. (EST); and November 7, 2018, from 1:00 p.m. - 2:30 p.m. (EST).

More information on TSCA implementation is available on our website under key phrase Lautenberg Implementation.  A detailed Bergeson & Campbell, P.C. (B&C®) memorandum on the TSCA user fees final rule is forthcoming.


 

By Lynn L. Bergeson and Carla N. Hutton

On August 31, 2018, the U.S. Environmental Protection Agency (EPA) submitted to the Office of Management and Budget (OMB) for review a final rule regarding user fees for the administration of the Toxic Substances Control Act (TSCA).  As reported in our February 9, 2018, memorandum, “Administrator Pruitt Signs TSCA User Fee Proposal,” as amended by the Frank Lautenberg Chemical Safety for the 21st Century Act, TSCA provides EPA the authority to levy fees on certain chemical manufacturers, including importers and processors, to “provide a sustainable source of funding to defray resources that are available for implementation of new responsibilities under the amended law.”  Under the amendments to TSCA, EPA has authority to require payment from manufacturers and processors who:

  • Are required to submit information by test rule, test order, or enforceable consent agreement (ECA) (TSCA Section 4);
  • Submit notification of or information related to intent to manufacture a new chemical or significant new use of a chemical (TSCA Section 5); or
  • Manufacture or process a chemical substance that is subject to a risk evaluation, including a risk evaluation conducted at the request of a manufacturer (TSCA Section 6(b)).

EPA’s February 26, 2018, proposed rule described the proposed TSCA fees and fee categories for fiscal years (FY) 2019, 2020, and 2021, and explained the methodology by which the proposed TSCA user fees were determined and would be determined for subsequent FYs.  In proposing the new TSCA user fees, EPA also proposed amending long-standing user fee regulations governing the review of Section 5 premanufacture notices (PMN), exemption applications and notices, and significant new use notices (SNUN).  Under the proposed rule, after implementation of final TSCA user fees regulations, certain manufacturers and processors would be required to pay a prescribed fee for each Section 5 notice or exemption application, Section 4 testing action, or Section 6 risk evaluation for EPA to recover certain costs associated with carrying out certain work under TSCA.  EPA did not propose specific fees for submission of confidential business information (CBI).


 

By Lynn L. Bergeson and Margaret R. Graham

On April 24, 2018, the U.S. Environmental Protection Agency (EPA) is scheduled to publish a notice in the Federal Register that it will be adding a supplemental analysis, “Supplemental Analysis of Alternative Small Business Size Standard Definitions and their Effect on TSCA User Fee Collection,” to the rulemaking docket for the User Fees for the Administration of the Toxic Substances Control Act (TSCA) proposed rule published on February 26, 2018.  EPA will also be extending the comment period for the proposed rule for an additional 30 days “to give interested parties the opportunity to consider this additional analysis and prepare meaningful comments.”  Comments will be due within 30 days of publication (by May 24, 2018).  The original comment deadline was April 27, 2018.

Regarding the supplemental analysis, EPA states that it “provides additional estimates for the impact of setting the small business definition based on an employee-based threshold.”  More information on the proposed rule is available in our February 9, 2018, memorandum “Administrator Pruitt Signs TSCA User Fee Proposal.”


 
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