All Knowledge & Insights By Date

On January 6, 2025, the U.S. Environmental Protection Agency (EPA) announced the extension of the review period for confidential business information (CBI) claims for specific identities of all active chemical substances listed on the confidential portion of the Toxic Substances Control Act (TSCA) Inventory submitted to EPA under TSCA. 90 Fed. Reg. 645. As reported in our February 7, 2024, blog item, EPA previously extended the review period by one year, to February 19, 2025....

On December 20, 2024, the U.S. Court of Appeals for the District of Columbia Circuit denied the Environmental Defense Fund’s (EDF) petition and granted the American Chemistry Council (ACC) and American Fuel and Petrochemical Manufacturers’ (AFPM) petition for review of the U.S. Environmental Protection Agency’s (EPA) final rule updating the requirements concerning the assertion and treatment of confidential business information (CBI) claims under the Toxic Substances Control Act (TSCA)....

On September 20, 2024, the U.S. Environmental Protection Agency (EPA) announced that it is extending the submission deadline for 2024 Chemical Data Reporting (CDR) reports from September 30, 2024, to November 22, 2024. The CDR regulations require manufacturers (including importers) of chemicals listed on the Toxic Substances Control Act (TSCA) Inventory to report data on the manufacturing, processing, and use of those chemicals every four years. For the 2024 data submission period, this applies...

The Chemical Data Reporting (CDR) rule requires manufacturers (including importers) to report data to the U.S. Environmental Protection Agency (EPA) every four years. The 2024 submission period began June 1, 2024, and will end September 30, 2024. The CDR rule requires all companies to report data electronically using e-CDRweb through EPA’s Central Data Exchange (CDX) system. CDR reporting in CDX is currently malfunctioning, however. EPA has issued two alerts:...

On June 10, 2024, the U.S. Environmental Protection Agency (EPA) issued a Federal Register notice announcing the availability of a draft Pesticide Registration Notice entitled Revised Procedures for Citing Data to Support Pesticide Registrations (EPA Forms No. 8570-34 and 8570-35) (Draft PR Notice). 89 Fed. Reg. 48893. EPA states that this Draft PR Notice will supersede PR Notice 98-5, entitled New Forms for the Certification with Respect to Citation of Data,which was issued on June...

The U.S. Environmental Protection Agency (EPA) announced on January 24, 2024, that it is extending the review period for confidential business information (CBI) claims for specific identity of all active chemical substances listed on the confidential portion of the Toxic Substances Control Act (TSCA) Inventory submitted to EPA under TSCA. 89 Fed. Reg. 4605. EPA states that it “has determined that an extension of the statutory review period for the review of CBI claims under...

The U.S. Environmental Protection Agency (EPA) announced on October 6, 2023, that it is deploying application updates, supporting new requirements under the Toxic Substances Control Act (TSCA) Confidential Business Information (CBI) Procedural Rule, within its electronic reporting site Central Data Exchange (CDX). EPA states that the deployments will update the applications requiring CBI substantiations to be provided within the application instead of requiring substantiation documents/templates...

As reported in our June 12, 2023, memorandum, the U.S. Environmental Protection Agency (EPA) published on June 7, 2023, a final rule with new and amended requirements concerning the assertion and treatment of confidential business information (CBI) claims for information reported to or otherwise obtained by EPA under the Toxic Substances Control Act (TSCA). EPA announced on August 10, 2023, that to ensure the “smoothest possible reporting experience” for TSCA submitters using...

The U.S. Environmental Protection Agency (EPA) held a webinar on July 18, 2023, on its recent final procedural rule for submitting confidential business information (CBI) under the Toxic Substances Control Act (TSCA). EPA has added a second webinar date, July 20, 2023, at 2:00 p.m. (EDT). The final rule increases transparency, modernizes the reporting and review procedures for CBI, and aligns with the 2016 amendments to TSCA. The rule will become effective on August 7, 2023. EPA...

By Lynn L. Bergeson and Carla N. Hutton   The U.S. Environmental Protection Agency (EPA) will hold a webinar on July 18, 2023, at 2:00 p.m. (EDT) on its recent final procedural rule for submitting confidential business information (CBI) under the Toxic Substances Control Act (TSCA). The final rule increases transparency, modernizes the reporting and review procedures for CBI, and aligns with the 2016 amendments to TSCA. The rule will become effective on August 7,...

The U.S. Environmental Protection Agency (EPA) will hold a webinar on July 18, 2023, at 2:00 p.m. (EDT) on its recent final procedural rule for submitting confidential business information (CBI) under the Toxic Substances Control Act (TSCA). The final rule increases transparency, modernizes the reporting and review procedures for CBI, and aligns with the 2016 amendments to TSCA. The rule will become effective on August 7, 2023. EPA states that the webinar will be useful for anyone looking...

The Organization for Economic Cooperation and Development (OECD) has published the latest edition of the Developments in Delegations on the Safety of Manufactured Nanomaterials and Advanced Materials — Tour de Table. The Tour de Table compiles information provided by delegations on the occasion of the 22nd meeting of the OECD Working Party on Manufactured Nanomaterials (WPMN) in June 2022.  The Tour de Table lists U.S. developments on the human health and...

May 17, 202311:00 a.m. – 12:00 p.m. EDT REGISTER NOW The U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) has advanced groundbreaking science policy initiatives in furtherance of implementation of the Toxic Substances Control Act (TSCA). As EPA advances New Approach Methodologies (NAM), cumulative risk assessment methodologies, and systematic review procedures, chemical stakeholders must understand directionally how these initiatives are...

The U.S. Environmental Protection Agency (EPA) announced on February 16, 2023, that the latest Toxic Substances Control Act (TSCA) Chemical Substance Inventory is now available on its website. The TSCA Inventory is a list of all existing chemical substances manufactured, processed, or imported in the United States. According to EPA, this update to the public TSCA Inventory is part of its biannual posting of non-confidential Inventory data. EPA plans the next regular update of the TSCA...

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  Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On May 12, 2022, EPA published a proposed rule relating to the assertion and maintenance of confidential business information (CBI) claims under TSCA. EPA states in its May 12, 2022, press release that the proposed rule includes new and amended requirements that, if made final, would increase transparency, modernize reporting and review procedures, and ensure consistency with the 2016 amendments to TSCA. In addition to providing...

On May 12, 2022, the U.S. Environmental Protection Agency (EPA) published a proposed rule relating to the assertion and maintenance of confidential business information (CBI) claims under the Toxic Substances Control Act (TSCA). 87 Fed. Reg. 29078. EPA states in its May 12, 2022, press release that the proposed rule includes new and amended requirements that, if made final, would increase transparency, modernize reporting and review procedures, and ensure consistency with the 2016...

On January 20, 2022, the U.S. Environmental Protection Agency (EPA) submitted a proposed rule to the Office of Management and Budget (OMB) concerning the procedures for submitting information subject to business confidentiality claims under the Toxic Substances Control Act (TSCA). According to an item in the fall 2021 Unified Agenda, EPA is considering proposing new and amended rules concerning the assertion and maintenance of claims of business confidentiality (i.e., confidential...

By Lynn L. Bergeson   On May 5, 2021, the U.S. Environmental Protection Agency (EPA) published a notice of disclosure to all obligated parties under the Renewable Fuel Standard (RFS) program that have submitted small refinery exemption (SRE) petitions and to all parties whose RFS information otherwise resides in EPA’s Moderated Transaction System (EMTS).  EPA’s action is in response to a U.S. Government of Accountability Office (GAO) request to disclose such...

On April 29, 2021, the U.S. Environmental Protection Agency (EPA) announced the release of a list of 390 chemicals that it states are “expected to lose their confidential status and move to the public portion of the Toxic Substances Control Act (TSCA) Inventory, furthering the agency’s commitment to data transparency.”  According to EPA, the specific identities of these chemicals were reported as non-confidential during Chemical Data Reporting (CDR) cycles from the 2012, 2016, and/or...

On April 29, 2021, the U.S. Environmental Protection Agency (EPA) announced the release of a list of 390 chemicals that it states are “expected to lose their confidential status and move to the public portion of the Toxic Substances Control Act (TSCA) Inventory, furthering the agency’s commitment to data transparency.”  According to EPA, the specific identities of these chemicals were reported as non-confidential during Chemical Data Reporting (CDR) cycles from the...

By Lynn L. Bergeson  EPA published on February 8, 2021, a periodic update of the TSCA confidential business information (CBI) review statistics. TSCA Section 14(g)(1) requires that EPA, within 90 days of receipt of a CBI claim: Review and make determinations on CBI claims for chemical identity after the chemical substance has been offered for commercial distribution; and   Review and make determinations on a representative subset of at least 25 percent of other CBI claims...

The U.S. Environmental Protection Agency (EPA) published on February 8, 2021, a periodic update of the Toxic Substances Control Act (TSCA) confidential business information (CBI) review statistics.  TSCA Section 14(g)(1) requires that EPA, within 90 days of receipt of a CBI claim: The updated data summarize the number of CBI cases under review and results of completed reviews through December 28, 2020.  In addition, a spreadsheet is available showing the details of completed TSCA...

On January 12, 2021, the U.S. Environmental Protection Agency (EPA) and the Occupational Safety and Health Administration (OSHA) announced a memorandum of understanding (MOU) that advances collaboration and communication on EPA’s review of new chemicals under the Toxic Substances Control Act (TSCA).  EPA states that the MOU provides a framework for coordination and communication between the two agencies on exposure to new chemicals in the workplace and will help achieve the...

By  Lynn L. Bergeson  EPA announced on January 5, 2021, that it is reopening the reporting period under the TSCA Inventory notification active-inactive rule where companies identified chemicals that were manufactured, imported, or processed in the United States during the ten-year time period ending on June 21, 2016. As reported in our June 26, 2017, memorandum, “EPA Issues Final TSCA Framework Rules,” the final TSCA Inventory notification (active-inactive) rule established...

The U.S. Environmental Protection Agency (EPA) announced on January 5, 2021, that it is reopening the reporting period under the Toxic Substances Control Act (TSCA) Inventory notification active-inactive rule where companies identified chemicals that were manufactured, imported, or processed in the United States during the ten-year time period ending on June 21, 2016.  As reported in our June 26, 2017, memorandum, “EPA Issues Final TSCA Framework Rules,” the final TSCA Inventory...

On October 16, 2020, the U.S. Environmental Protection Agency (EPA) reminded companies that if they filed a retrospective activity notice (Notice of Activity (NOA) Form A) under the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Rule and claimed the specific chemical identity as confidential business information (CBI), they have until November 1, 2020, to submit or amend their CBI substantiations.  Companies that amend, update, or file new CBI...

On May 29, 2020, the U.S. Environmental Protection Agency (EPA) released updated data collected during the 2016 Chemical Data Reporting (CDR) period.  EPA notes that the updated 2016 CDR data now include information that was previously classified as confidential business information (CBI), such as aggregate production volumes and site-specific production volumes.  EPA published an initial release of the 2016 CDR data in May 2017.  The Frank R. Lautenberg Chemical Safety...

By Lynn L. Bergeson EPA will host a webinar on May 19, 2020, from 1:00 p.m. to 3:00 p.m. (EDT) to provide an overview of the 2020 CDR requirements. The webinar will include information about the revised reporting requirements, including: New requirements for making confidential business information (CBI) claims; Reporting refinements related to byproducts, including exemptions; Phasing in certain processing and use data codes; and Process improvements for reporting co-manufacturing. The webinar...

The U.S. Environmental Protection Agency (EPA) will host a webinar on May 19, 2020, from 1:00 to 3:00 p.m. (EDT) to provide an overview of the 2020 Chemical Data Reporting (CDR) requirements.  The 2020 CDR submission period is from June 1, 2020, to November 30, 2020.  The webinar will include information about the revised reporting requirements, including: The webinar will also introduce the updated e-CDRweb reporting tool.  EPA notes that the presentation will...

By Lynn L. Bergeson On April 10, 2020, the U.S. Environmental Protection Agency (EPA) published a quarterly update of the Toxic Substances Control Act (TSCA) confidential business information (CBI) review statistics. The data summarize the number of CBI cases under review and results of completed reviews through March 1, 2020. In addition, a spreadsheet showing the details of completed TSCA CBI determinations through March 1, 2020, is available. EPA states that making this information publicly...

 The U.S. Environmental Protection Agency (EPA) published on August 11, 2020, its quarterly update of the Toxic Substances Control Act (TSCA) confidential business information (CBI) review statistics.  These data summarize the number of CBI cases under review and results of completed reviews through June 15, 2020: CBI Review Statistics (cases received between June 22, 2016 and June 15, 2020) Cases in which the specific chemical identity is subject to CBI review 3,326 Cases in...

The U.S. Environmental Protection Agency (EPA) published on April 10, 2020, the quarterly update of the Toxic Substances Control Act (TSCA) confidential business information (CBI) review statistics.  The data summarize the number of CBI cases under review and results of completed reviews through March 1, 2020.  In addition, a spreadsheet showing the details of completed TSCA CBI determinations through March 1, 2020, is available.  EPA states that making this information publicly available...

By Lynn L. Bergeson On March 6, 2020, EPA published its final rule on procedures for review of confidential business information (CBI) claims made under TSCA. 85 Fed. Reg. 13062. The final rule includes the requirements for regulated entities to substantiate certain CBI claims made under TSCA to protect the specific chemical identities of chemical substances on the confidential portion of the TSCA Inventory, and EPA’s plan for reviewing certain CBI claims for specific chemical...

By Lynn L. Bergeson On March 6, 2020, EPA announced via the Federal Register its final rule on requirements for regulated entities to substantiate certain confidential business information (CBI) made under TSCA. The substantiation requirements describe the applicable procedures and provide instructions for regulated entities, providing the review criteria and related procedures that EPA will use to complete the reviews within the five-year time frame set in TSCA. The final rule will be effective...

By Lynn L. Bergeson On February 19, 2020, the U.S. Environmental Protection Agency (EPA) released its review plan for certain confidential business information (CBI) claims under the Toxic Substances Control Act (TSCA). Aiming to provide clarity for affected stakeholders and efficiently fulfill CBI requirements under TSCA, EPA will review CBI claims made for chemical substance identity for chemicals on the “active” portion of the TSCA Inventory. The final rule is a follow-on to the...

The U.S. Environmental Protection Agency (EPA) released on February 19, 2020, a final rule concerning the process companies must follow to make certain confidential business information (CBI) claims and EPA’s plan for reviewing those claims.  EPA describes its final rule as creating “an efficient process” for fulfilling the CBI requirements under the Toxic Substances Control Act (TSCA) and providing clarity for affected stakeholders.  Following the procedures set forth in the...

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...

By Lynn L. Bergeson The U.S. Environmental Protection Agency (EPA) announced on December 9, 2019, that in advance of its December 10, 2019, public meeting on new chemicals, it is providing the meeting materials and announcing the availability of a new web page detailing cases with completed confidential business information (CBI) determinations under the Toxic Substances Control Act (TSCA). Materials for the December 10, 2019, meeting include: Agenda; and   Presentation. The new CBI web...

The U.S. Environmental Protection Agency (EPA) announced on December 9, 2019, that in advance of the December 10, 2019, public meeting on new chemicals, it is providing the meeting materials and announcing the availability of a new web page detailing cases with completed confidential business information (CBI) determinations under the Toxic Substances Control Act (TSCA).  Materials for the December 10, 2019, meeting include: The new CBI web page includes a table of all the final CBI...

The U.S. Environmental Protection Agency (EPA) will hold a public meeting on December 10, 2019, to engage with interested stakeholders on the implementation of EPA’s Toxic Substances Control Act (TSCA) New Chemicals program.  At the meeting, EPA will: By the end of 2019, EPA intends to announce the availability of the updated “Working Approach” document and provide an opportunity for written public comment.  EPA states that feedback from the public meeting and comments...

On November 8, 2019, the U.S. Environmental Protection Agency (EPA) published in the Federal Register a supplemental notice of proposed rulemaking regarding revisions to the confidential business information (CBI) substantiation requirements under the Toxic Substances Control Act (TSCA).  84 Fed. Reg. 60363.  EPA states that in response to a recent federal circuit court decision, it is proposing revisions to existing and proposed substantiation requirements for...

By Lynn L. Bergeson On October 30, 2019, EPA announced that in response to an April 2019 court decision on the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements Final Rule, EPA will publish a supplemental notice of proposed rulemaking that includes two additional questions about “reverse engineering” that manufacturers and processors would be required to answer when making confidential business information (CBI) claims. According to EPA, these...

On October 30, 2019, the U.S. Environmental Protection Agency (EPA) announced that in response to an April 2019 court decision on the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements Final Rule, EPA will publish a supplemental notice of proposed rulemaking that includes two additional questions about “reverse engineering” that manufacturers and processors would be required to answer when making confidential business information (CBI)...

The U.S. Environmental Protection Agency (EPA) announced on September 19, 2019, that it posted the first public Toxic Substances Control Act (TSCA) Inventory to include unique identifier (UID) information.  EPA states that the UID is a numerical identifier assigned to a chemical substance when EPA approves a confidential business information (CBI) claim for specific chemical identity.  When EPA approves such a claim, it assigns a UID to that chemical identity; applies the UID...

In a significant victory for industry, on August 27, 2019, the State of New York Supreme Court invalidated the New York Department of Environmental Conservation (NYDEC) Household Cleansing Product Information Disclosure Program (Disclosure Program).  Information related to NYDEC’s prior delay of its enforcement of its Disclosure Program is available here, and general information regarding the Program and its extensive requirements for manufacturers of certain consumer cleaning products to...

In a significant victory for industry, on August 27, 2019, the State of New York Supreme Court invalidated the New York Department of Environmental Conservation (NYDEC) Household Cleansing Product Information Disclosure Program (Disclosure Program).  Information related to NYDEC’s prior delay of its enforcement of its Disclosure Program is available here, and general information regarding the Program and its extensive requirements for manufacturers of certain consumer cleaning products to...

 In a significant victory for industry, on August 27, 2019, the State of New York Supreme Court invalidated the New York Department of Environmental Conservation (NYDEC) Household Cleansing Product Information Disclosure Program (Disclosure Program).  Information related to NYDEC’s prior delay of its enforcement of its Disclosure Program is available here, and general information regarding the Program and its extensive requirements for manufacturers of certain consumer...

The cost of generating health and safety studies is considerable and data owners have every right to expect some protection from disclosure to preserve the value of their intellectual property.  This is no longer guaranteed as Lynn L. Bergeson, Richard E. Engler, Ph.D., and Kathleen M. Roberts wrote in a two-part article in Bloomberg Environment Insights. The authors propose that the U.S. Environmental Protection Agency’s (EPA) practice of...

The U.S. Environmental Protection Agency (EPA) has published statistics concerning its review of confidential business information (CBI) cases received between June 22 2016, and June 25, 2019.  The Frank R. Lautenberg Chemical Safety for the 21st Century Act, enacted in 2016, amended the CBI provisions of the Toxic Substances Control Act (TSCA).  Since then, EPA “has established numerous new processes, systems, and procedures to enable submitters to provide the information...