All Knowledge & Insights By Date

On February 1, 2024, the U.S. Environmental Protection Agency (EPA) released guidance to clarify how it will evaluate “absence of an ingredient” claims for pesticide products regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). EPA states that it is aware that the regulated community seeks clarity on whether and how “absence of an ingredient” claims can be made lawfully on FIFRA-regulated product labels. EPA states that it will consider an “absence of...

On July 19, 2023, the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA) posted a blog item entitled “Making Voices Heard in the Regulatory Process,” announcing the release of “guidance detailing new steps that Federal agencies should take to make it easier for interested members of the public to voice their views in the regulatory process.” According to OIRA, new directions to federal agencies in the guidance include: OIRA’s guidance...

On February 25, 2022, the U.S. Environmental Protection Agency (EPA) announced that it is revoking the 1980 guidelines and associated procedures for correcting the specific chemical identities of incorrectly described chemical substances submitted to EPA in 1978 using the original reporting form for inclusion on the Toxic Substances Control Act (TSCA) Inventory. 87 Fed. Reg. 10781. EPA states that it is providing a final opportunity to use the 1980 guidelines and form to request corrections of...

The U.S. Environmental Protection Agency (EPA) published a proposed rule on September 28, 2021, that would codify the definition of “parent company” for purposes of reporting to the Toxics Release Inventory (TRI). 86 Fed. Reg. 53577. Although the existing regulation requires a facility reporting to TRI to identify its parent company in annual reporting forms, no codified definition of this data element exists. EPA states that a codified definition of parent company would allow it to...

On August 23, 2021, the U.S. Environmental Protection Agency (EPA) announced the availability of and solicited public comment on guidance on two petition processes applicable to the Toxic Substances Control Act (TSCA) Chemical Data Reporting (CDR) regulations. 86 Fed. Reg. 47102. The guidance covers petitions for full exemption of byproduct substances that are recycled or otherwise used within site-limited, physically enclosed systems and petitions for partial exemption of chemicals for which...

On December 22, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of new interim guidance on destroying and disposing of certain perfluoroalkyl and polyfluoroalkyl substances (PFAS) and PFAS-containing materials for public comment.  85 Fed. Reg. 83554.  The interim guidance outlines the current state of the science on techniques and treatments that may be used to destroy or dispose of PFAS and PFAS-containing materials from non-consumer products,...

On February 28, 2020, the U.S. Environmental Protection Agency (EPA) announced that, in support of President Trump’s (R) Executive Order to promote transparency, EPA launched a new guidance portal that provides public access to its guidance documents.  According to EPA, the new searchable database will make it easier for the regulated community to find and follow agency guidance.  On October 9, 2019, President Trump issued Executive Order 13891, Promoting the Rule...

Bergeson & Campbell, P.C. (B&C®) will present a webinar regarding confidential business information (CBI) as related to chemical regulation on September 18, 2018.  Register for “TSCA Confidential Business Information and Generic Naming: Analyzing the New Rules” online.  This webinar is part of the 2018 Chemical Policy Summit Series presented by B&C and Bloomberg Next. On June 21, 2018, the U.S. Environmental Protection Agency (EPA) issued guidance...

On June 22, 2018, the U.S. Environmental Protection Agency (EPA) announced that it has met its statutory responsibilities under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) to release guidance and policy on confidential business information (CBI), a strategy to reduce animal testing, and a final mercury reporting rule.  As noted in our June 29, 2016, memorandum, “TSCA Reform:  EPA Publishes First Year Implementation Plan,” the...

On June 20, 2018, the U.S. Environmental Protection Agency (EPA) issued guidance intended “to improve transparency with the public and with companies seeking Agency review of their new chemical substances under the Toxic Substances Control Act (TSCA).”  EPA states that the guidance, entitled Points to Consider When Preparing TSCA New Chemical Notifications, “promotes early engagement and communication, and enhances overall understanding of EPA’s technical review and analysis to...

On June 14, 2018, the U.S. Environmental Protection Agency (EPA) announced that it will soon publish in the Federal Register a Notice of Availability (NOA) stating that worker safety training materials, including the expanded subject matter required by the 2015 Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Worker Protection Standard (WPS) for agricultural workers and pesticide handlers, are available for use.  The prepublication version of the NOA is available...

On May 30, 2018, two complaints were filed against the U.S. Environmental Protection Agency (EPA) in the United States District Court for the Southern District of New York.  Both of these suits concern a decision by EPA to defer publication of a notice of availability (NOA) of training materials prepared pursuant to the Agricultural Worker Protection Standard (WPS), 40 C.F.R. Part 170.  The WPS was originally promulgated in 1974, substantially amended in 1992, and then...

On March 13, 2018, the U.S. Environmental Protection Agency (EPA) released three draft guidance documents for public comment clarifying the circumstances under which EPA may disclose Toxic Substances Control Act (TSCA) confidential business information (CBI) with an expanded set of people.  Amended TSCA Section 14(d) expanded the categories of people to whom EPA may disclose TSCA CBI by specifically authorizing EPA to disclose TSCA CBI to state, tribal, and local governments; environmental,...

On February 1, 2018, the U.S. Environmental Protection Agency (EPA) announced it is publishing new guidance that sets forth a tiered approach intended to help manufacturers and EPA determine when the number of field trials necessary to register seed treatment uses can be reduced.  In its memo and attached Seed-Treatment Focus Group (STFG) Guidance Document dated January 26, 2018, EPA states that its Health Effect Divison (HED) has received “multiple waiver requests for seed-treatment...

On August 1, 2017, the U.S. Environmental Protection Agency (EPA) announced the availability of two final test method Standard Operating Procedures (SOP) for evaluating the efficacy of antimicrobial pesticides against two biofilm bacteria, Pseudomonas aeruginosa (P. aeruginosa) and Staphylococcus aureus (S. aureus): EPA also released regulatory guidance for test criteria and pesticide claims for these products, specifically Guidance for Testing the Efficacy of...

In a May 11, 2017, letter from U.S. Environmental Protection Agency (EPA) Acting Assistant Administrator Wendy Cleland-Hamnett to the CEO of the National Association of State Departments of Agriculture (NASDA) posted by Bloomberg’s BNA Daily Environment Report, Cleland-Hamnett states that it is appropriate to grant NASDA’s request to delay implementation of all revised provisions to the agricultural Worker Protection Standard (WPS) “until the necessary guidance and training have been...

The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on May 16, 2017, announcing the availability of and requesting public comment on a draft guidance document entitled “Guidance on EPA’s Section 8(a) Information Gathering Rule on Nanomaterials in Commerce.” 82 Fed. Reg. 22452.  The promised guidance provides answers to questions EPA has received from manufacturers (includes importers) and processors of certain chemical substances when they are...

On October 12, 2016, the U.S. Environmental Protection Agency (EPA) announced a public meeting on the draft Algae Guidance for the Preparation of [Toxic Substances Control Act (TSCA)] Biotechnology Submissions (Algae Guidance) in the Federal Register.  This meeting will receive public input and comments on the draft Algae Guidance that describes EPA’s data needs for supporting risk assessments of genetically engineered algae and cyanobacteria that are manufactured, imported, or...

The U.S. Environmental Protection Agency (EPA) posted guidance regarding changes to the requirements for making confidential business information (CBI) claims under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act.  The “key changes” that EPA notes are: New Certification Requirement.  Pursuant to TSCA § 14(c), a submitter of information claimed as CBI must now certify agreement with several...

The Environment Protection Agency (EPA) extended the comment date on its draft guidance, Pesticide Cumulative Risk Assessment: Framework for Screening Analysis, in a Federal Register notice published on August 28, 2015.  EPA’s draft framework provides guidance on how the EPA will screen groups of pesticides for cumulative evaluation.  EPA proposes using a two-step approach, beginning with the evaluation of available toxicological information and, if necessary,...