Archives

October 12, 2023

FDA Seeks Comment on Cosmetics Direct and Forms Regarding Registration of Cosmetic Product Facility and Cosmetic Product Listing

On September 15, 2023, the U.S. Food and Drug Administration (FDA) announced that it is seeking comment on its newly developed draft electronic submission portal (Cosmetics Direct) and paper forms (Forms FDA 5066 and 5067). The submission portal and paper forms are part of FDA’s implementation of the new registration and listing requirements mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). FDA has provided screenshots of the draft electronic system, draft Form...
February 2, 2022

ECHA Publishes Update to the Appendix for Nanoforms

The European Chemicals Agency (ECHA) has published a January 2022 update to the Appendix for nanoforms applicable to the Guidance on Registration and Substance Identification (version 2.0). The main changes to the document include additional guidance on the joint submission of data, clarifications regarding the need for one data set per nanoform or set of nanoforms, and information on the registration of sets of nanoforms versus single nanoforms. Changes to the Appendix are limited to...
November 24, 2021

EPA Announces Extension of Emerging Viral Pathogens Guidance for COVID 19

On November 19, 2021, the U.S. Environmental Protection Agency (EPA) announced that it is extending COVID-19 activation of the emerging viral pathogens (EVP) guidance for antimicrobial pesticides indefinitely. EPA states that its EVP guidance for antimicrobial pesticides is a part of the federal government’s pandemic preparedness, allowing manufacturers to provide EPA with data, even in advance of an outbreak, demonstrating that their products are effective against hard-to-kill...
November 3, 2021

Federal Agencies Reaffirm Commitment to Protecting Endangered Species, Providing Effective Pest Control Tools, and Regulating Pesticide Use in a Fair, Transparent, and Predictable Manner

On November 3, 2021, the U.S. Environmental Protection Agency (EPA), the White House Council on Environmental Quality (CEQ), the U.S. Department of Agriculture (USDA), the U.S. Department of Commerce, and the U.S. Department of the Interior “reaffirm[ed] their commitment to working together and with stakeholders to protect endangered species, provide effective pest control tools, and regulate pesticide use in a fair, transparent, and predictable manner.” According to EPA’s November 3,...
September 20, 2021

EPA Announces Sunset of Temporary Disinfectant Supply Chain Flexibilities

On September 15, 2021, the U.S. Environmental Protection Agency (EPA) announced that it is terminating the Temporary Amendment to Pesticide Registration (PR) Notice 98-10, effective September 15, 2022. EPA states that it is providing 12 months’ notice to registrants before the termination takes effect to give registrants time to adjust their contractual commitments. Registrants must ensure that by September 15, 2022, their product is produced using a source of active...
June 14, 2021

PMRA Issues Interim Order to Regulate Certain UV Radiation-emitting and Ozone-generating Devices under the Pest Control Products Act

On June 7, 2021, Health Canada’s Pest Management Regulatory Agency (PMRA) announced the issuance of its Interim Order Respecting Ultraviolet Radiation-emitting Devices and Ozone-generating Devices under the Pest Control Products Act (Interim Order), setting forth new requirements for certain devices claiming to control, destroy, make inactive, or reduce the level of bacteria, viruses, and other micro-organisms that are human pathogens. PMRA also issued an “Explanatory...
October 28, 2020

EPA Seeks Comment on Its Interim Guidance on Residual Efficacy Claims

On October 26, 2020, the U.S. Environmental Protection Agency (EPA) announced that it is soliciting public comment on the interim guidance on registering products that claim to have “residual” or “long-lasting” effectiveness against viruses.  This announcement follows up on EPA’s October 14, 2020, announcement that it would begin expediting its review of products with residual efficacy intended for use against SARS-CoV-2, the coronavirus that causes...
October 21, 2020

EPA’s Draft Residual Efficacy Protocols for “Long-Lasting” Efficacy for Antiviral Products

On October 14, 2020, the U.S. Environmental Protection Agency (EPA) released a much-anticipated draft guidance that will allow companies to demonstrate that their products have “long-lasting” or “residual” effectiveness on surfaces against viruses like SARS-CoV-2, the coronavirus that causes COVID-19.  EPA’s guidance specifies scientific testing requirements for two different types of products:  (1) disinfectants that also provide residual efficacy, and (2)...
October 14, 2020

EPA Announces Expedited Pathway for Companies to Claim “Long-Lasting” Efficacy for Antiviral Products

On October 14, 2020, the U.S. Environmental Protection Agency (EPA) released much-anticipated draft guidance that will allow companies to demonstrate that their products have “long-lasting” or “residual” effectiveness on surfaces against viruses like SARS-CoV-2, the coronavirus that causes COVID-19.  As most know, EPA has not before now provided guidance on how stakeholders can demonstrate to EPA’s satisfaction that their product remains efficacious for periods of time,...
July 30, 2020

EPA Announces the Approval of 13 Additional Products Effective against SARS-CoV-2

On July 30, 2020, the U.S. Environmental Protection Agency (EPA) announced it approved amended labels for 13 products based on laboratory testing that shows the products are effective against SARS-CoV-2, the virus that causes COVID-19. These products, and two previously announced products (see our July 7, 2020, blog), are the only products for which EPA has reviewed laboratory testing data and approved label claims specifically against SARS-CoV-2.  In January 2020, at the...