This June marks the ninth anniversary of the enactment of the game-changing Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg) that amended the Toxic Substances Control Act (TSCA). With a new Trump Administration and the relentless pace of regulatory developments related to Lautenberg implementation, there are many issues to consider and problems to solve. Save the date to join Bergeson & Campbell, P.C. (B&C®), the Environmental Law Institute (ELI), and...
April 30, 2025
National Biotechnology Initiative Act Would Implement Recommendations from NSCEB’s Final Report
As reported in our April 25, 2025, blog item, the National Security Commission on Emerging Biotechnology (NSCEB) announced on April 8, 2025, the availability of its final report and action plan, “urging Congressional action to bring the full weight of American innovation to improve and maintain U.S. global leadership in biotechnology.” On April 9, 2025, Senator Alex Padilla (D-CA), an NSCEB Commissioner, and the other three Congressional Commissioners introduced the bipartisan, bicameral...
The U.S. Environmental Protection Agency (EPA) announced on April 28, 2025, that it has issued an emergency fuel waiver allowing the sale of gasoline blended with 15 percent ethanol (E15) nationwide in summer 2025. EPA notes that this is consistent with President Trump’s Executive Order (EO) Declaring a National Energy Emergency, directing EPA to consider issuing emergency waivers to allow for year-round E15 sales. According to EPA, currently, in about half of the country, E15...
April 29, 2025
PFAS Updates: What’s Happening in the U.S. and EU, May 13, 2025, 11:00 a.m. – 12:00 p.m. (EDT), via webinar
Register now to join Bergeson & Campbell, P.C. (B&C®) affiliate The Acta Group (Acta®) and EPPA for “PFAS Updates: What’s Happening in the U.S. and EU,” a complimentary webinar offering expert updates on per- and polyfluoroalkyl substances (PFAS) regulatory developments. These substances are attracting global legal, regulatory, commercial, and litigation attention as no other “emerging contaminant” has. While the U.S. Administration is new, PFAS regulation continues at a...
On April 17, 2025, the U.S. Environmental Protection Agency (EPA) extended the comment period on a draft risk assessment of the potential human health risks associated with the presence of perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS) in biosolids, also known as sewage sludge. 90 Fed. Reg. 16128. According to EPA, the draft risk assessment “reflects the agency’s latest scientific understanding of the potential risks to human health and the environment posed by the...
The National Security Commission on Emerging Biotechnology (NSCEB) announced on April 8, 2025, the availability of its final report and action plan, “urging Congressional action to bring the full weight of American innovation to improve and maintain U.S. global leadership in biotechnology.” After an extensive study that included “more than 1,800 stakeholder consultations, a holistic review of unclassified and classified material, site visits across the United States, and meetings with...
On April 25, 2025, the U.S. Environmental Protection Agency (EPA) announced the availability of new resources intended to help companies with the requirements described in EPA’s December 2024 final rule governing the review of new chemicals under the Toxic Substances Control Act (TSCA). According to EPA, the new materials “provide companies with clear instructions on how to include required data elements in the current system used for new chemical submissions while the agency works to...
On April 18, 2025, the U.S. Environmental Protection Agency (EPA) announced updates to its pesticide registration tracking app, MyPest. EPA states MyPest allows registrants of pesticide products to monitor the status of their pesticide registration submissions in real time. The launch of the latest version of MyPest includes updates to an enhanced dashboard page with information about the registrant’s cases and products, the ability to view detailed information of each application, and the...
April 24, 2025
Recalibrating Regulation: EPA, Energy, and the Unfolding Consequences of Deregulatory Momentum
The U.S. Environmental Protection Agency (EPA) has long navigated the complex intersection of science, law, policy, and public trust. Under the Trump Administration, EPA faces renewed scrutiny. The Administration seeks regulatory rollbacks and is pursuing a broader deregulatory strategy that many believe risks sacrificing hard won environmental protections in the name of economic growth. While early promises to reduce bureaucratic red tape struck a chord with a number in industry, implementation...
There are a variety of accounts on the progress and success of the first days of the Trump Administration. Some put special significance on a new administration’s first 100 days, but is this the first 100 days or four years + 100 days? In particular, appearing April 21, 2025, in The Washington Post, there is a report tracing what has happened to the “Five Things” mandate coming from Elon Musk and the DOGE (Department of...
April 16, 2025
Petitions Filed to Add Chemicals to List of Chemical Substances Subject to Superfund Excise Tax
On April 2 and April 3, 2025, the Internal Revenue Service (IRS) announced that petitions have been filed to add the following chemicals to the list of taxable substances: Comments on the petitions are due June 2, 2025. More information on the Superfund excise tax on chemicals is available in our July 13, 2022, memorandum, “Superfund Tax on Chemicals: What You Need to Know to Comply” and our May 19, 2022, memorandum, “Reinstated Superfund Excise...
April 15, 2025
EUON Publishes Nanopinion on Enhancing the Regulatory Application of NAMs to Assess Nanomaterial Risks in the Food and Feed Sector
On April 8, 2025, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “A Qualification System to Accelerate Development and Regulatory Implementation of New Approach Methodologies (NAMs)” by Andrea Haase, Ph.D., German Federal Institute for Risk Assessment (BfR), Shirin M. Usmani, Ph.D., BfR, Irene Cattaneo, European Food Safety Authority (EFSA), Maria Chiara Astuto, EFSA, and Francesco Cubadda, Ph.D., National Institute of Health (ISS). The authors...
April 15, 2025
EPA Postpones Effective Date of Certain Provisions of TCE Risk Management Rule to June 20, 2025
On April 2, 2025, the U.S. Environmental Protection Agency (EPA) announced that it is postponing the effectiveness of certain provisions of its December 17, 2024, final risk management rule for trichloroethylene (TCE) until June 20, 2025. 90 Fed. Reg. 14415. After EPA issued the final rule in December 2024, it received multiple petitions for an administrative stay of the effective date. EPA denied the requests, and the companies submitted renewed petitions to stay the effective...
On April 11, 2025, the Office of Management and Budget (OMB) published a request for information to solicit ideas for deregulation. 90 Fed. Reg. 15481. OMB seeks proposals to rescind or replace regulations “that stifle American businesses and American ingenuity,” including regulations “that are unnecessary, unlawful, unduly burdensome, or unsound.” According to the notice, “comments should address the background of the rule and the reasons for the proposed rescission, with particular...
As reported in our April 1, 2025, blog item, the Maine Board of Environmental Protection (MBEP) was scheduled to consider the Maine Department of Environmental Protection’s (MDEP) December 2024 proposed rule regarding products containing per- and polyfluoroalkyl substances (PFAS) during its April 7, 2025, meeting. As reported in our December 31, 2024, memorandum, on December 20, 2024, MDEP published a proposed rule that would establish criteria for currently unavoidable uses (CUU) of...
Congress has approximately one month to use the Congressional Review Act (CRA) to undo qualifying Biden Administration-issued regulations. According to an updated analysis by Bloomberg Government, the estimated period to expedite repeal of Biden Administration rules ends May 8, 2025. This gives Congress approximately four weeks to act on the dozens of pending CRA bills. President Trump’s focus on overturning Biden Administration regulations through the CRA has taken a back seat of late to...
April 9, 2025
EC Scientific Committee Begins Public Consultation on Preliminary Opinion on Hydroxyapatite (Nano)
On April 3, 2024, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) began a public consultation on its preliminary opinion on the safety of hydroxyapatite (nano) in oral products. The EC asked SCCS if it considers hydroxyapatite (nano) safe when used in toothpaste up to a maximum concentration of 29.5 percent and in mouthwash up to a maximum concentration of ten percent according to the specifications as reported in the submission, taking into...
On April 3, 2025, the U.S. Environmental Protection Agency (EPA) announced changes on how the data matrix form (EPA Form 8570-35) is submitted to EPA, stating this change is an improvement to simplify the process for how companies submit data to EPA as part of a pesticide registration package. EPA states these improvements also will make EPA’s processing of this information more efficient. Companies are required to submit a data matrix form when their pesticide...
April 7, 2025
NSF Announces PFAS-Free Certification for Nonfood Compounds and Food Equipment Materials
On March 24, 2025, NSF announced the release of NSF Certification Guideline 537: PFAS-Free Products for Nonfood Compounds and Food Equipment Materials (NSF 537). The press release states that to be certified, nonfood compound products “must first be registered under NSF’s Nonfood Compounds Guidelines or certified by NSF to ISO 21469, Safety of Machinery, Lubricants with Incidental Product Contact-Hygiene Requirements.” According to the press release, food equipment materials “must be...
April 2, 2025
USDA Will Fund 543 Projects in 29 States Through Higher Blends Infrastructure Incentive Program
On March 31, 2025, the U.S. Department of Agriculture (USDA) announced that it will release obligated funding under the Higher Blends Infrastructure Incentive Program (HBIIP) for 543 projects totaling $537 million in 29 states. According to the press release, USDA is “aggressively exploring additional ways to unleash American energy and incentivize the production and use of homegrown U.S. biofuels, including working alongside the Environmental Protection Agency (EPA) to develop Renewable...
Recent press reports tell of rumors of impactful (some fear catastrophic) budget cuts to the U.S. Environmental Protection Agency (EPA). Politically, priority on reducing EPA’s climate programs, along with budget and personnel cuts, are not surprising given the election results. Recent rumors include chatter that the EPA Office of Research and Development (ORD) might be eliminated and/or its staff redistributed, with a specific target on the back of ORD’s Integrated Risk Information System...
The European Commission (EC) began a public consultation on March 31, 2025, on the upcoming European Union (EU) Bioeconomy Strategy. The EC states in its March 31, 2025, press release that the Strategy “marks a significant step forward in harnessing the opportunities of the bioeconomy to support European businesses and drive progress towards the EU’s environmental, climate and competitiveness objectives.” According to the call for evidence, the Strategy’s main aims include: The EC...
April 1, 2025
Maine Board of Environmental Protection Will Consider Proposed PFAS Rule at Its April 7, 2025, Meeting
The Maine Board of Environmental Protection (MBEP) will consider the Maine Department of Environmental Protection’s (MDEP) December 2024 proposed rule regarding products containing per- and polyfluoroalkyl substances (PFAS) during its April 7, 2025, meeting. As reported in our December 31, 2024, memorandum, on December 20, 2024, MDEP published a proposed rule that would establish criteria for currently unavoidable uses (CUU) of intentionally added PFAS in products and implement sales...
March 31, 2025
APHIS Evaluates Petitions Reviewed under 2012 Process, Will Use Process Consistent with USDA Biotechnology Regulations Going Forward
The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on March 27, 2025, that it will no longer use the process it outlined in 2012 for reviewing petitions seeking a determination that a modified plant should not be subject to the regulations for the introduction of organisms altered or produced through genetic engineering (modified organisms) that are plant pests or that there is reason to believe are plant pests. On...
On March 21, 2025, the U.S. Court of Appeals for the District of Columbia Circuit heard oral argument in a case challenging the U.S. Environmental Protection Agency’s (EPA) May 3, 2024, final rule amending the procedural framework rule for conducting risk evaluations under the Toxic Substances Control Act (TSCA). United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, Allied Industrial and Service Workers International Union (USW) v. EPA, Consolidated Case No. 24-1151. If you have a...
March 27, 2025
EPA Extends 2024 RFS Compliance Reporting Deadline
The U.S. Environmental Protection Agency (EPA) issued a final rule on March 14, 2025, extending the Renewable Fuel Standard (RFS) compliance reporting deadline for the 2024 compliance year. 90 Fed. Reg. 12109. As reported in our January 8, 2025, blog item, EPA published a proposed rule on December 12, 2024, that would partially waive the 2024 cellulosic biofuel volume requirement and revise the associated percentage standard under the RFS program due to a shortfall in...
On March 24, 2025, the U.S. Environmental Protection Agency (EPA) provided an update on the effective date of the Toxic Substances Control Act (TSCA) final risk management rule for trichloroethylene (TCE). As reported in our January 13, 2025, memorandum, on December 17, 2024, EPA issued a final rule prohibiting all uses of TCE, most of which would be prohibited within one year, including TCE manufacture and processing for most commercial and all consumer products. As...
On March 14, 2025, President Trump signed Executive Order (EO) 14236, rescinding 19 executive actions, including former President Biden’s September 2022 EO 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy.” 90 Fed. Reg. 13037. According to the White House’s March 14, 2025, fact sheet, EO 14081 “funneled Federal resources into radical biotech and biomanufacturing initiatives under the guise of environmental...
March 20, 2025
Amazon Files Suit against CPSC, Challenging CPSC’s Determination That Amazon Is a Distributor
On March 14, 2025, Amazon filed suit against the Consumer Product Safety Commission (CPSC) in the U.S. District Court for the District of Maryland, challenging CPSC’s July 29, 2024, and January 16, 2025, orders determining that Amazon is “a ‘distributor’ of certain products that are defective or fail to meet federal consumer product safety standards, and therefore bears legal responsibility for their recall.” According to CPSC’s January 17, 2025, announcement, “[m]ore than 400,000...
March 19, 2025
What It Means to Be “Essential” in the Federal Workforce
Current news on the government efficiency and reform front concerns the near-miss of a government shutdown last week (the budget would have lapsed at midnight on March 14, 2025). One reason some cited against allowing a shutdown to occur is how it might encourage or otherwise aid in attempts to eliminate positions if they were deemed “essential” or not. As one who has gone through the “who is essential” exercise in a senior management position...
March 17, 2025
Council of the EU Agrees on Negotiating Mandate on Plants Obtained by New Genomic Techniques
The Council of the European Union (EU) announced on March 14, 2025, that the Committee of the Permanent Representatives of the Governments of the Member States to the EU (Coreper) endorsed the Council’s negotiating mandate on the regulation on plants obtained by new genomic techniques (NGT) and their food and feed. The regulation proposed by the European Commission (EC) would create two ways for NGT plants to be placed on the market: The proposed regulation...
After President Trump’s address to Congress on Tuesday, March 4, 2025, it is unclear if there will be much desire or willingness on behalf of the Democrats and Republicans to collaborate on legislation during the 119th Congress. President Trump and congressional Republicans are moving toward “one big, beautiful” reconciliation bill (that is possible to enact without Democratic support) that will reflect most of President Trump’s priorities. The question is: what happens after...
March 12, 2025
EPA Reschedules SACC Meetings to Consider 1,3-Butadiene Draft Risk Evaluation, Will Issue Supplement
The U.S. Environmental Protection Agency (EPA) announced on March 11, 2025, the rescheduled meeting dates of the Science Advisory Committee on Chemicals (SACC) that had been previously scheduled for February 2025 to consider and review the draft risk evaluation for 1,3-butadiene. 90 Fed. Reg. 11737. The rescheduled preparatory meeting for the SACC to consider the scope and clarity of the revised draft charge questions for the peer review will now be held on March 25,...
The U.S. Environmental Protection Agency (EPA) announced on March 7, 2025, that it is extending the comment period on the draft risk evaluation for dicyclohexyl phthalate (DCHP) under the Toxic Substances Control Act (TSCA). EPA released the risk evaluation for DCHP on January 7, 2025, with a comment period that closed March 10, 2025. EPA states that it will soon publish a Federal Register notice extending the public comment period for an additional 60 days....
March 11, 2025
EU Advocate General Recommends Overturning Decision Annulling Harmonized Classification and Labeling of Titanium Dioxide
On February 6, 2025, the European Union (EU) Advocate General (EU AG) recommended that the European Court of Justice (ECJ) overturn the 2022 decision of the General Court annulling the 2019 harmonized classification and labeling of titanium dioxide as a carcinogenic substance by inhalation in certain powder forms. As reported in our December 6, 2022, memorandum, the court annulled the European Commission’s (EC) decision to classify titanium dioxide as a suspected human carcinogen. The French...
March 10, 2025
EPA Extends Comment Period on Draft Scope Document for Vinyl Chloride TSCA Risk Evaluation
On March 5, 2025, the U.S. Environmental Protection Agency (EPA) extended the comment period on the draft scope of the risk evaluation to be conducted under the Toxic Substances Control Act (TSCA) for vinyl chloride. 90 Fed. Reg. 11315. As reported in our January 28, 2025, memorandum, under TSCA, the scope documents must include the conditions of use (COU), hazards, exposures, and the potentially exposed or susceptible subpopulations (PESS) that EPA expects to consider in...
The U.S. Environmental Protection Agency (EPA) announced on March 6, 2025, that it plans to issue a rule “soon” to extend the reporting deadline for a rule under Section 8(d) of the Toxic Substances Control Act (TSCA) requiring manufacturers (including importers) of 16 chemicals to report data from unpublished health and safety studies to EPA. The rule applies to manufacturers in the North American Industrial Classification System (NAICS) codes for chemical manufacturing (NAICS code 325)...
On March 4, 2025, the U.S. Environmental Protection Agency (EPA) announced that it is reopening the comment period for the January 2025 proposed rule to address the unreasonable risk of injury to human health presented by Color Index (C.I.) Pigment Violet 29 (PV29) under its conditions of use (COU) as documented in EPA’s January 2021 risk evaluation and September 2022 revised risk determination. 90 Fed. Reg. 11142. Comments are due April 29, 2025. As reported...
On January 16, 2025, Senators Jerry Moran (R-KS), Chuck Grassley (R-IA), Tammy Duckworth (D-IL), Pete Ricketts (R-NE), Amy Klobuchar (D-MN), and Joni Ernst (R-IA) reintroduced the Farm to Fly Act (S. 144), which would help accelerate the production and development of sustainable aviation fuel (SAF) through existing U.S. Department of Agriculture (USDA) programs to allow further growth for alternative fuels to be used in the aviation sector and create new markets for American farmers. According...
Headlines this weekend refer to “renewed chaos” over e-mails sent to federal employees at most (some? all?) agencies of the government — asking employees to list their five accomplishments for the week. In our February 24, 2025, blog item, we explored how employees might answer such vague requests in the absence of more guidance about who is asking and what is to be reported. The larger issue is that the current turmoil and confused information...
The U.S. Department of Energy’s (DOE) Bioenergy Technologies Office (BETO) announced on February 7, 2025, that its 2025 Project Peer Review, initially planned for April 22-25, 2025, is postponed until a future, yet to be determined, date. According to BETO, approximately 200 projects in its research, development, and demonstration portfolio “will be presented to the public and systematically reviewed by experts from industry, academia, and federal agencies.” BETO notes that the 2025...
March 3, 2025
ABA and B&C Announce Release of “Chemical Product Law and Supply Chain Stewardship” Book
Bergeson & Campbell, P.C. (B&C®) is pleased to announce the release by American Bar Association (ABA) Publishing of Chemical Product Law and Supply Chain Stewardship: A Guide to New TSCA, edited by B&C Managing Partner Lynn L. Bergeson and authored by Ms. Bergeson and members of B&C’s highly experienced Toxic Substances Control Act (TSCA) practice group. This invaluable guide provides a road map to navigate efficiently the transformational changes in chemical product law,...
February 28, 2025
EPA OIG Publishes Independent Audit of EPA’s FYs 2022 and 2021 (Restated) TSCA Service Fee Fund Financial Statements
On February 26, 2027, the U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) published a report entitled Independent Audit of the EPA’s Fiscal Years 2022 and 2021 (Restated) Toxic Substances Control Act Service Fee Fund Financial Statements. Under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, EPA is required to prepare and OIG to audit the accompanying financial statements of the...
The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on February 27, 2025, that it will begin to accept petitions for nonregulated status according to APHIS biotechnology regulations at 7 C.F.R. Part 340 (2019) on March 3, 2025. APHIS notes that its biotechnology regulations enable developers to petition for a determination that an “article” is not regulated. The petition process applies only to plants that meet the regulatory definition...
February 27, 2025
GAO’s Updated High-Risk List Still Includes EPA’s Process for Assessing and Controlling Toxic Chemicals
On February 25, 2025, the U.S. Government Accountability Office (GAO) issued a report entitled High-Risk Series: Heightened Attention Could Save Billions More and Improve Government Efficiency and Effectiveness, “highlight[ing] 38 areas across the federal government that are seriously vulnerable to waste, fraud, abuse, and mismanagement or that are in need of transformation.” The category “Seizing Opportunities to Better Protect Public Health and Reduce Risk” lists high-risk areas...
February 27, 2025
House Leadership Announces Priorities for Congressional Review Act Action; No TSCA Rules Are in the Top Ten Targets
Much has been written about the Congressional Review Act (CRA), which Congress can use to repeal qualifying federal agency actions. The CRA was enacted as part of the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA). According to the Congressional Research Service (CRS), through 2024 the CRA was used to repeal 20 rules, including 16 during President Trump’s first term. The CRA was also used successfully one time in the 107th Congress (2001-2002) under...
On February 21, 2025, the U.S. Environmental Protection Agency (EPA) extended the comment deadline for the January 17, 2025, proposed rule to clarify the timeframe for when companies must first notify a customer that one of its mixtures or trade name products contains a per- or polyfluoroalkyl substance (PFAS) listed on the Toxics Release Inventory (TRI). 90 Fed. Reg. 10043. As reported in our January 22, 2025, blog item, the Biden EPA proposed the rule...
February 24, 2025
How to Summarize Government Work in Five Easy Bullets
It was reported this weekend that all federal employees received an e-mail from the Office of Personnel Management (OPM) telling employees to report “five bullets about what you did last week.” The e-mail also states that failure to do so would be interpreted to mean that the employee is offering their resignation. This is reported as part of the drive to shake up or reform, review, or rebuke the federal workforce. Whatever one speculates about...
February 21, 2025
March 14, 2025, Looming as Important Date for Congressional Republicans and President Trump, and May Provide Leverage to Democrats
March 14, 2025, looms as an important deadline in the middle of President Trump’s first 100 days in office, a milestone often used to evaluate the effectiveness of a new President. March 14 is the day that the American Relief Act, 2025 (Public Law 118-158), which provides temporary funding for the federal government, expires. The law was enacted during the 118th Congress and signed into law by President Biden. At the time, some questioned whether...
February 14, 2025
OECD Tour de Table Includes Information on International Developments Regarding Nanomaterials
The Organisation for Economic Co-operation and Development (OECD) has published the Developments in Delegations on the Safety of Manufactured Nanomaterials and Advanced Materials between July 2023 and June 2024 — Tour de Table (Tour de Table). Below are highlights on international developments from the Tour de Table:...