All Knowledge & Insights By Date

By Lynn L. Bergeson On November 20, 2019, the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) announced a public meeting to engage with stakeholders interested on the implementation of the Toxic Substances Control Act (TSCA) New Chemicals Program. The meeting will be held on December 10, 2019, from 10:00 a.m. to 3:00 p.m. (EST), and will include: An overview of EPA’s updated “Working Approach” document that builds on...

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 11, 2019, the U.S. Environmental Protection Agency (EPA) published proposed significant new use rules (SNUR) for 31 chemical substances, including multiwalled carbon nanotubes (generic), that were the subject of premanufacture notices (PMN).  84 Fed. Reg. 54816.  EPA notes that eight of the chemical substances are subject to orders under the Toxic Substances Control Act (TSCA) issued by EPA.  The effective date of the TSCA Section 5(e) order for multiwalled...

We are pleased to announce that the Fall 2019 issue of The SciTech Lawyer, published by the American Bar Association’s (ABA) Section of Science and Technology Law, includes an article co-authored by Lynn L. Bergeson and Carla N. Hutton, “Nanotechnology and Regulatory Certainty Closer Now Than Ever.”  Nanoscale technologies and their resultant innovations have long captured the imaginations of scientists and inventors, the scrutiny of regulators, and the apprehension of...

By Lynn L. Bergeson On August 29, 2019, an article titled Population susceptibility: A vital consideration in chemical risk evaluation under the Lautenberg Toxic Substances Control Act was published in the PLOS Biology Journal. The article, written by academics, criticizes EPA for not identifying pregnant women, infants, children, families near industrial sites, and other susceptible and highly exposed populations in its risk evaluations. This lack of consideration for vulnerable populations,...

By Lynn L. Bergeson The U.S. Environmental Protection Agency (EPA) announced on August 1, 2019, that it is making additional information about new chemical notices available on its website.  The new web page, “Statistics for the New Chemicals Review Program under TSCA,” allows users to view and search monthly updates for any active Premanufacture Notice (PMN), Significant New Use Notice (SNUN), and Microbial Commercial Activity Notice (MCAN) of interest by case number. ...

The U.S. Environmental Protection Agency (EPA) announced on August 1, 2019, that it is making additional information about new chemical notices available on its website.  The new web page, “Statistics for the New Chemicals Review Program under TSCA,” allows users to view and search monthly updates for any active Premanufacture Notice (PMN), Significant New Use Notice (SNUN) and Microbial Commercial Activity Notice (MCAN) of interest by case number.  Users can also download a...

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A. On July 25, 2019, Bergeson & Campbell, P.C. (B&C®) hosted a webinar titled “New TSCA at 3: Key Implementation Issues” led by B&C’s Managing Partner, Lynn L. Bergeson. Webinar speakers included the U.S. Environmental Protection Agency’s (EPA) Assistant Administrator, Alexandra Dapolito Dunn, and B&C’s Director of Chemistry and former EPA staff, Richard E. Engler, Ph.D. Assistant Administrator...

Bergeson & Campbell, P.C. (B&C®) would like to thank all of the participants that made “TSCA: Three Years Later” such a success. Speakers, including Alexandra Dapolito Dunn, Assistant Administrator, OCSPP, EPA, and Lynn R. Goldman, M.D., M.S., M.P.H., Michael and Lori Milken Dean and Professor of Environmental and Occupational Health at Milken Institute School of Public Health, George Washington University, provided timely insights into EPA’s implementation of the...

By Lynn L. Bergeson The Environmental Defense Fund (EDF) announced on June 17, 2019, a report entitled Toxic Consequences: Trump’s attacks on chemical safety put our health at risk. EDF notes that “[c]oncern over toxic exposures and a lack of confidence in the badly outdated chemical safety system” led to Congress passing the Frank R. Launtenberg Chemical Safety for the 21st Century Act (Launtenberg Act) to reform the Toxic Substances Control Act (TSCA). The bipartisan...

On June 14, 2019, the U.S. Environmental Protection Agency (EPA) announced that on May 24, 2019, EPA received manufacturer requests for EPA to conduct risk evaluations of diisodecyl phthalate (DIDP) from ExxonMobil Chemical Company and diisononyl phthalate (DINP) from ExxonMobil Chemical Company, Evonik Corporation, and Teknor Apex, both through the American Chemistry Council’s High Phthalates Panel.  EPA states that both DIDP and DINP belong to a family of chemicals commonly referred to...

By Lynn L. Bergeson On May 28, 2019, Bergeson & Campbell, P.C. (B&C®) posted a podcast “Inside OCSPP with EPA Assistant Administrator Alexandra Dapolito Dunn” to its All Things Chemical™ web page. In its podcast, Lynn L. Bergeson, Managing Partner of B&C, presented a very special guest, the Assistant Administrator for the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP):  Alexandra Dapolito Dunn....

Please check out Bergeson & Campbell, P.C.’s (B&C®) new podcast “Inside OCSPP with EPA Assistant Administrator Alexandra Dapolito Dunn” on its All Things Chemical™ webpage.  In this podcast, Lynn L. Bergeson, Managing Partner of B&C, presents a very special guest, the Assistant Administrator for EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP):  Alexandra Dapolito Dunn.  As Assistant Administrator Dunn...

Bergeson & Campbell, P.C. (B&C®), the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health are pleased to present the one day conference “TSCA: Three Years Later” on June 24, 2019. Panelists Alexandra Dunn, Assistant Administrator, Office of Chemical Safety and Pollution Prevention (OCSPP), EPA, and Lynn R. Goldman, Michael and Lori Milken Dean and Professor, Environmental and Occupational Health, Milken...

By Lynn L. Bergeson On May 20, 2019, the U.S. Environmental Protection Agency (EPA) announced that on May 30, 2019, it will begin publishing Toxic Substances Control Act (TSCA) Section 5 notices, including premanufacture notices (PMN), microbial commercial activity notices (MCAN), and significant new use notices (SNUN), their attachments, including any health and safety studies, any modifications thereto, and all other associated information in ChemView — in the form they are received by...

On May 16, 2019, the U.S. Environmental Protection Agency (EPA) announced that it has updated its Statistics for the New Chemicals Review Program under TSCA web page, which is under EPA’s Reviewing New Chemicals under the Toxic Substances Control Act (TSCA) section, to make it easier to find and understand how many chemicals are in each stage of the new chemicals review process.  The revised web page now includes a flow chart showing the number of new...

The U.S. Environmental Protection Agency (EPA) released on March 20, 2019, a list of 20 chemicals that EPA has suggested as candidates for high priority designation under the Toxic Substances Control Act (TSCA), as reported in our March 22, 2019, memorandum “EPA Releases List of 40 Chemicals Undergoing Prioritization for Risk Evaluation.”  Should those chemicals go forward as high priority, they will be subject to risk evaluation under TSCA Section 6.  Industry...

By Lynn L. Bergeson On April 26, 2019, the U.S. Court of Appeals for the D.C. Circuit (D.C. Circuit) issued its order on the petition for review of the U.S. Environmental Protection Agency’s (EPA) final rule on the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements (82 Fed. Reg. 37520 (Aug. 11, 2017)), which denied the petition for review on all but one claim.  Petitioner Environmental Defense Fund (EDF) challenged five distinct features of...

On May 1, 2019, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) sent a memorandum to Alexandria Dapolito Dunn, Assistant Administrator, Office of Chemical Safety and Pollution Prevention, announcing that it “plans to begin preliminary research on the Office of Pollution Prevention and Toxics processes to implement the work to meet statutory deadlines of the Lautenberg Act.”  OIG’s objectives are to determine whether EPA has met the deadlines...

By Lynn L. Bergeson On April 25, 2019, EPA issued a proposed rule that would amend the TSCA Section 8(a) Chemical Data Reporting (CDR) requirements and the TSCA Section 8(a) size standards for small manufacturers. The current CDR rule requires manufacturers (including importers) of certain chemical substances listed on the TSCA Inventory to report data on chemical manufacturing, processing, and use every four years.  EPA is proposing several changes to the CDR rule to make...

By Lynn L. Bergeson On April 23, 2019, the U.S. Environmental Protection Agency (EPA) issued a proposed rule regarding its plan to review certain confidential business information (CBI) claims to protect the specific chemical identities of substances on the confidential portion of the Toxic Substances Control Act (TSCA) Inventory.  84 Fed. Reg. 16826.  The CBI claims that would be reviewed under this plan are those that were asserted on Notice of Activity (NOA) Form A’s...

On April 25, 2019, the U.S. Environmental Protection Agency (EPA) issued a proposed rule that would amend the Toxic Substances Control Act (TSCA) Section 8(a) Chemical Data Reporting (CDR) requirements and the TSCA Section 8(a) size standards for small manufacturers.  84 Fed. Reg. 17692.  The current CDR rule requires manufacturers (including importers) of certain chemical substances listed on the TSCA Chemical Substance Inventory (TSCA Inventory) to report data on chemical manufacturing,...

On April 23, 2019, the U.S. Environmental Protection Agency (EPA) issued a proposed rule regarding its plan to review certain confidential business information (CBI) claims to protect the specific chemical identities of substances on the confidential portion of the Toxic Substances Control Act (TSCA) Inventory.  84 Fed. Reg. 16826.  The CBI claims that would be reviewed under this plan are those that were asserted on Notice of Activity (NOA) Form A’s filed in accordance with the...

On April 11, 2019, the U.S. Environmental Protection Agency (EPA) announced that it was partnering with the Physicians Committee for Responsible Medicine (PCRM) and the People for the Ethical Treatment of Animals (PETA) International Science Consortium to host a public webinar related to meeting the goal of reducing, refining, or replacing vertebrate animal testing as stipulated in the Frank R. Lautenberg Chemical Safety for the 21st Century Act that amended the Toxic Substances Control Act...

On March 11, 2019, the U.S. Environmental Protection Agency (EPA) released its Fiscal Year (FY) 2020 Justification of Appropriation Estimates for the Committee on Appropriations.  EPA’s budget request reduces the overall budget by $2.76 billion (31 percent), to $6.068 billion, but requests $66.418 million to support its Chemical Risk Review and Reduction (CRRR) program, an increase of $5.313 million.  EPA zeros out the other programs under Toxics Risk Review and Prevention,...

On April 5, 2019, the U.S. Environmental Protection Agency (EPA) issued a final rule that will establish final significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 13 chemical substances that are the subject of premanufacture notices (PMN).  84 Fed. Reg. 13531. The final rule is significant because the 13 chemical substances are not also subject to consent orders.  During the review, EPA identified certain reasonably foreseen conditions of use that it...

On March 27, 2019, the House Science, Space, and Technology Subcommittee on Investigations and Oversight and Subcommittee on Environment held a hearing on “EPA’s IRIS Program:  Reviewing its Progress and Roadblocks Ahead.”  The hearing focused on issues with the U.S. Environmental Protection Agency’s (EPA) Integrated Risk Information System (IRIS) Program, as described in two recent reports issued by the U.S. Government Accountability Office (GAO), Chemical Assessments:  Status of...

By Lynn L. Bergeson On March 21, 2019, the U.S. Environmental Protection Agency (EPA) announced it was releasing a list of 40 chemicals to begin the prioritization process required by the amended Toxic Substances Control Act (TSCA).  84 Fed. Reg. 10491.  New TSCA requires EPA to designate 20 chemicals as “high-priority” for subsequent risk evaluation and 20 chemicals as “low-priority,” meaning that risk evaluation is not warranted at this time.  The 20 high...

On May 20, 2019, the U.S. Environmental Protection Agency (EPA) announced that on May 30, 2019, it will begin publishing Toxic Substances Control Act (TSCA) Section 5 notices including premanufacture notices (PMN), microbial commercial activity notices (MCAN), and significant new use notices (SNUN), their attachments, including any health and safety studies, any modifications thereto, and all other associated information in ChemView — in the form they are received by EPA, without...

GAO released on March 6, 2019, a report entitled High-Risk Series:  Substantial Efforts Needed to Achieve Greater Progress on High-Risk Areas.  GAO’s high-risk program identifies government operations with vulnerabilities to fraud, waste, abuse, and mismanagement, or in need of transformation to address economy, efficiency, or effectiveness challenges.  GAO’s report describes the status of high-risk areas and outlines actions necessary to assure further progress.  GAO states that in the...

On February 8, 2019, the U.S. Environmental Protection Agency (EPA) published in the Federal Register its notice extending the review periods for all Toxic Substances Control Act (TSCA) Section 5 Premanufacture Notices (PMN), Significant New Use Notices (SNUN), Microbial Commercial Activity Notices (MCAN), and exemption notices that were submitted to the Agency under TSCA Section 5 before December 29, 2018, and for which the review period had not expired as of December 29,...

On February 1, 2019, Lynn Vendinello, Acting Director, Chemical Control Division, of the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) signed the pre-publication version of a notice announcing that, due to the recent lapse of appropriations and the Agency shutdown, EPA is extending the review periods for all Toxic Substances Control Act (TSCA) Section 5 Premanufacture Notices (PMN), Significant New Use Notices (SNUN), Microbial...

On February 1, 2019, Lynn Vendinello, Acting Director, Chemical Control Division, of the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) signed the pre-publication version of a notice announcing that, due to the recent lapse of appropriations and the Agency shutdown, EPA is extending the review periods for all Toxic Substances Control Act (TSCA) Section 5 Premanufacture Notices (PMN), Significant New Use Notices (SNUN), Microbial...

Bergeson & Campbell, P.C. (B&C®) and its consulting affiliate The Acta Group (Acta®) published on January 8, 2019, our “Forecast for U.S. Federal and International Chemical Regulatory Policy 2019.”  In this richly detailed document, the legal, scientific, and regulatory professionals of B&C and Acta distill key trends in U.S. and global chemical law and provide our best informed judgment as to the shape of key developments we are likely to see in 2019.  This edition...

By Lynn L. Bergeson On December 21, 2018, the U.S. Environmental Protection Agency (EPA) announced in the Federal Register that the Syracuse Research Corporation (SRC) will be assisting the EPA Office of Pollution Prevention and Toxics (OPPT) in the creation of a database that will cover key data from past biotechnology submissions, and the creation of a biotechnology literature database with documents provided or referenced in Toxic Substances Control Act (TSCA) biotechnology submissions. The...

As the U.S. Environmental Protection Agency (EPA) is currently closed due to the lapse in appropriations, EPA has ceased all work reviewing new and existing chemicals under the Toxic Substances Control Act (TSCA).  Regarding new chemicals, although the Central Data Exchange (CDX) may still accept submissions, EPA will not process any information submitted via CDX until EPA reopens and it is not clear how EPA will set “Day 1” for TSCA Section 5 notices submitted during...

On December 31, 2018, the U.S. Environmental Protection Agency (EPA), even though they had already shut down due to funding issues, announced that if the government shutdown continues through 5:00 p.m. (EST) January 4, 2019, the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals’ (SACC) January 8, 2019, Preparatory Virtual Meeting for the January 29 through February 1, 2019, meeting on Colour Index (C.I.) Pigment Violet 29 will be cancelled, and...

The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on December 7, 2018, withdrawing significant new use rules (SNUR) promulgated under the Toxic Substances Control Act (TSCA) for 28 chemical substances, including single-walled carbon nanotubes, that were the subject of premanufacture notices (PMN).  As reported in our October 10, 2018, blog item, EPA issued the SNURs through a direct final rule on October 10, 2018.  EPA states that it...

The U.S. Environmental Protection Agency (EPA) is scheduled to publish a Federal Register notice on December 4, 2018, withdrawing significant new use rules (SNUR) promulgated under the Toxic Substances Control Act (TSCA) for 26 chemical substances, including carbon nanomaterial (generic), that were the subject of premanufacture notices (PMN).  As reported in our October 2, 2018, blog item, EPA issued the SNURs through a direct final rule on October 3, 2018.  EPA states that it received...

On October 17, 2018, the Trump Administration published its Unified Agenda of Regulatory and Deregulatory Actions (Regulatory Agenda).  There are many interesting entries, some of which are flagged here. Not surprisingly, the U.S. Environmental Protection Agency (EPA) listed implementing Toxic Substances Control Act (TSCA) amendments to enhance public health and chemical safety as one of its top priorities.  According to EPA, the amendments to TSCA that were enacted in June 2016...

By Lynn L. Bergeson On October 16, 2018, the Office of Information and Regulatory Affairs released the Trump Administration’s Fall 2018 Unified Agenda of Regulatory and Deregulatory Actions (Agenda). The Agenda aims to report on actions that administrative agencies, such as EPA, plan to put forward in the near- and long-terms. As its name implies, the Agenda includes both regulatory and deregulatory actions and attempts to justify any burden associated with these actions. According to...

By Lynn L. Bergeson 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)...

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...

By Lynn L. Bergeson On September 27, 2018, the U.S. Environmental Protection Agency (EPA) announced 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...

The U.S. Environmental Protection Agency (EPA) is scheduled to publish on October 3, 2018, a direct final rule promulgating significant new use rules (SNUR) for 26 chemical substances, including carbon nanomaterial (generic), that were the subject of premanufacture notices (PMN).  The chemical substances are subject to orders issued by EPA pursuant to Sections 5(e) and 5(f) of the Toxic Substances Control Act (TSCA).  The direct final rule requires persons who intend to...

The U.S. Environmental Protection Agency (EPA) published on October 10, 2018, a direct final  rule promulgating significant new use rules (SNUR) for 28 chemical substances, including  single-walled carbon nanotubes, that were the subject of premanufacture notices (PMN).  The chemical substances are subject to orders issued by EPA pursuant to Section 5(e) of the Toxic Substances Control Act (TSCA).  The direct final rule requires persons who intend to manufacture...

On October 5, 2018, the U.S. Environmental Protection Agency (EPA) issued the general approaches that the Office of Pollution Prevention and Toxics (OPPT) may use to identify potential candidate chemicals for prioritization under TSCA.  83 Fed. Reg. 50366.  EPA notes that it will seek public comment on the approach document and on which chemicals should be identified as potential candidates for the initial 20 high-priority and 20 low-priority chemicals that must be identified...

Borrowing from William Shakespeare … WHAT’S IN A NAME? That which we call a biobased chemical. By any other name would stand as sustainable. And yet, it is the mere name of the biobased chemical that hinders its ability to go to market! Did you know that the Toxic Substances Control Act (TSCA) is interpreted and applied in ways that often cause new biobased chemicals and their derivatives to be subject to stringent premarket review...

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...

By Lynn L. Bergeson On September 11, 2018, Bloomberg Environment Insights published a three-part article series, written by Bergeson & Campbell, P.C. (B&C®), on the impact of the new Toxic Substances Control Act (TSCA) Section 5 and its implementation. Despite the U.S. Environmental Protection Agency’s (EPA) overall timely and balanced efforts in the implementation of TSCA, EPA’s approach to TSCA Section 5 implementation has proved itself less successful. With emphasis on...