All Knowledge & Insights By Date

On December 31, 2024, the U.S. Environmental Protection Agency (EPA) announced the availability of and solicited comment on the preliminary lists of manufacturers (including importers) subject to fees for the next five chemicals undergoing risk evaluation under Section 6(b) of the Toxic Substances Control Act (TSCA). 89 Fed. Reg. 107099. The five chemicals that have been designated as High-Priority Substances (HPS) for risk evaluation and for which fees will be charged are acetaldehyde (Chemical...

The U.S. Environmental Protection Agency (EPA) has released the annual pesticide registration maintenance fee materials for fiscal year (FY) 2025. The deadline for payment of EPA’s annual maintenance fee for pesticide registration is January 15, 2025. Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 4(i)(1)(A) requires everyone who holds an active or suspended pesticide registration granted under FIFRA Sections 3 and 24(c) (special local needs) to pay an annual maintenance...

Elections bring significant change, especially in Presidential election years. During the 76-day period between Election Day and Inauguration Day, President-elect Trump and his transition team are busy selecting people to serve in his Administration. Congress has even less time, only 59 days from the election until the 119th Congress convenes January 3, 2025, at noon. A previous post looks at what Congress may do during the lame duck period. This post looks at who will...

On July 29, 2024, the California Department of Pesticide Regulation (DPR) announced that it will move forward with an emergency rulemaking package to revise the fees for pesticide registrations and renewals in late August with a proposed effective date of no later than October 1, 2024. DPR states the fee increase is necessary to meet current baseline funding needs and the new positions approved as part of the Fiscal Year (FY) 2024-2025 budget. DPR states...

On April 17, 2024, the California Department of Pesticide Regulation (DPR) announced the details of its webinar scheduled for Tuesday, April 23, 2024, at 10:00 a.m. (PDT). The webinar is to discuss and receive feedback from registrants and other stakeholders on DPR’s intent to increase registration fees to a level that, according to DPR, supports the current and future business needs of the pesticide registration program. DPR states it has determined that current registration fees...

The U.S. Environmental Protection Agency (EPA) has released the annual pesticide registration maintenance fee materials for fiscal year 2024. The January 16, 2024, deadline for payment of the U.S. Environmental Protection Agency’s (EPA) annual maintenance fee for pesticide registrations is fast approaching. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 4(i)(1)(A) requires everyone who holds an active or suspended pesticide registration granted under FIFRA Sections 3...

The U.S. Environmental Protection Agency’s (EPA) spring 2023 Unified Agenda, published on June 13, 2023, includes the following rulemakings under the Toxic Substances Control Act (TSCA) or the Toxics Release Inventory (TRI). Proposed Rule Stage Final Rule Stage...

By Lynn L. Bergeson and Carla N. Hutton The U.S. Environmental Protection Agency (EPA) will hold a webinar on December 6, 2022, to provide an overview to stakeholders about its November 16, 2022, supplemental proposed rule modifying and adjusting certain aspects of the fees rule established under the Toxic Substances Control Act (TSCA). EPA states that it is publishing these changes to ensure that collected fees provide it with 25 percent of authorized TSCA costs...

The U.S. Environmental Protection Agency’s (EPA) spring 2022 Unified Agenda, published on June 21, 2022, includes the following rulemakings under the Toxic Substances Control Act (TSCA) or the Toxics Release Inventory (TRI). Proposed Rule Stage Final Rule Stage...

By Richard E. Engler, Ph.D., and Carla N. Hutton The U.S. Environmental Protection Agency (EPA) announced on November 23, 2021, legally mandated changes to the fee requirements under the Toxic Substances Control Act (TSCA). This is not the fee adjustment we have been awaiting. It is a routine increase that TSCA directs EPA every three years to adjust the fees. The adjustment will go into effect on January 1, 2022, and will apply to all...

By Lynn L. Bergeson Under Canada’s New Substances Fees Regulations, fees must be provided with each New Substance Notification (NSN) package submitted under the New Substance Notification Regulations (Chemicals and Polymers). The amount of the fee is dependent on the annual sales in Canada for the notifier, the specific Schedule being submitted, and other services being requested (e.g., confidential search on the Domestic Substances List (DSL) or Non-Domestic Substances List (NDSL) or...

Under Canada’s New Substances Fees Regulations, fees must be provided with each New Substance Notification (NSN) package submitted under the New Substance Notification Regulations (Chemicals and Polymers).  The amount of the fee is dependent on the annual sales in Canada for the notifier, the specific Schedule being submitted, and other services being requested (e.g., confidential search on the Domestic Substances List (DSL) or Non-Domestic Substances List (NDSL) or masked name...

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. EPA announced that it is extending the public comment period on proposed updates to the Toxic Substances Control Act (TSCA) Fees Rule to give stakeholders more time to review and comment. The current comment period was set to close on February 25, 2021. Comments are now due on March 27, 2021. Information on the proposed updates is available in the Bergeson & Campbell, P.C. (B&C®) December 30, 2020, memorandum,...

The U.S. Environmental Protection Agency (EPA) announced on February 19, 2021, that it is extending the public comment period on proposed updates to the Toxic Substances Control Act (TSCA) fees rule to give stakeholders more time to review and comment.  The current comment period was set to close on February 25, 2021.  EPA is extending the comment period an additional 30 days.  Information on the proposed updates is available in our December 30, 2020, memorandum, “EPA Intends...

By  Lynn L. Bergeson  On January 11, 2021, EPA published a proposed rule that would amend the 2018 Toxic Substances Control Act (TSCA) fees rule. 86 Fed. Reg. 1890. Under TSCA, EPA collects fees from chemical manufacturers and processors to help fund implementation and to ensure that public health and the environment continue to be protected. TSCA requires EPA to review its fees every three years and, after consulting with parties potentially subject to the fees,...

On January 11, 2021, the U.S. Environmental Protection Agency (EPA) published a proposed rule that would amend the 2018 Toxic Substances Control Act (TSCA) fees rule.  86 Fed. Reg. 1890.  Under TSCA, EPA collects fees from chemical manufacturers and processors to help fund implementation and to ensure that public health and the environment continue to be protected.  TSCA requires EPA to review its fees every three years and, after consulting with parties potentially...

Last week, press reported that the U.S. Food and Drug Administration (FDA) would assess distilleries making hand sanitizer $14,060 in fees as Monograph Drug Facilities (MDF) under the Over-the-Counter (OTC) Monograph Drug user fee program for fiscal year (FY) 2021.  Several days later, on December 31, 2020, the Department of Health and Human Services (HHS) Office of Public Affairs tweeted a statement from Brian Harrison, HHS Chief of Staff.  According to the...

By Lynn L. Bergeson  On August 4, 2020, the U.S. Food and Drug Administration (FDA) Department of Health and Human Services (DHHS) announced the rates for biosimilar user fees for fiscal year (FY) 2021. The fees assessed are used by FDA for certain activities in connection with biosimilar biological product development, review of applications for approval of biosimilar biological products, and approval of product applications. The established fees will apply from October 1, 2020, through...

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...

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...