EPA Finalizes Rule: TSCA Reporting and Recordkeeping Requirements for PFAS

On September 28, 2023, EPA finalized the rule for Recordkeeping and Reporting Requirements of Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) under the Toxic Substances Control Act (TSCA). This rule requires reporting of information on uses, production volume, disposal, exposure, and hazards of PFAS manufactured or imported since January 1, 2011. Reporting will be submitted electronically through [...]

The Ripple Effect of Regulations: Cosmetic Regulation (EC) No. 1223/2009 Amendments

On August 15, 2023, amendments to the European Union’s Cosmetic Regulation (EC) No. 1223/2009 will take effect. Among these amendments is an update to fragrance allergens listed in Annex III, which adds 56 new substances. Although these amendments are specific to an EU regulation, products sold into the state of California may be impacted. California’s [...]

2023-08-10T18:20:25+00:00EPA|

EPA Releases Draft Guidance to Expand Availability of Virus Claims to Additional Antimicrobial Products 

On July 17, 2023, EPA released for public comment its Draft Guidance for the Evaluation of Products for Claims Against Viruses. This draft guidance outlines the pathway and testing requirements for food and non-food contact sanitizer products to make claims against viruses. Historically, a sanitizer has not been eligible for virucidal claims unless it was [...]

2023-07-24T20:46:52+00:00EPA|

EPA Extends Emerging Viral Pathogens Policy for Rabbit Hemorrhagic Disease Virus (RHDV2) Indefinitely

UPDATE: On July 27, 2023, EPA updated the Emerging Viral Pathogens Policy web page with the indefinite extension of the EVP policy for Rabbit Hemorrhagic Disease Virus (RHDV2). In July 2020, EPA triggered its Emerging Viral Pathogens Policy (EVP) to allow off-label claims against Rabbit Hemorrhagic Disease Virus (RHDV2) to address the U.S. outbreak of [...]

2023-07-27T19:42:21+00:00EPA|

The EPA Non-PRIA Notification Close Out Has Arrived

Effective June 28, 2023, all antimicrobial notifications submitted to the Antimicrobials Division (AD) prior to October 1, 2022 have been closed out by the Environmental Protection Agency (EPA). The Agency announcement, released on June 29, 2023, followed months of discussion between AD and the antimicrobial industry about how to best address the growing backlog of [...]

EPA Triggers Emerging Viral Pathogens Policy for Marburg Virus

In response to recent simultaneous outbreaks of Marburg virus in Tanzania and Equatorial Guinea the United States EPA has engaged the Emerging viral Pathogens Policy (EVP). The Ministry of Health and Social Welfare for Equatorial Guinea first announced the outbreak on February 7, 2023. Since the announcement, 15 cases and 11 deaths have been confirmed [...]

Interim Guidance for Products Including or Adding Efficacy Claims for Use on Porous Materials in Non-Residential Settings

On December 21, 2022, EPA published an Interim Guidance and two new methods to add bacterial and viral disinfection claims on porous surfaces.  The guidance and methods may be used immediately for claim support, though registrants should be aware that EPA released the guidance with a 30-day comment period that was then extended through February [...]

2023-01-19T15:37:27+00:00EPA, Test Management|

SRC Summary of Changes in EPA Guidance for Products Adding Residual Efficacy Claims

On October 7th, EPA released its new Guidance for Products Adding Residual Efficacy Claims. After a thorough review including a comparative review of historical documents and all linked methods, and the Response to Comments document, Scientific & Regulatory Consultants, Inc. (SRC) has created the below summary of changes. Registrants are being given a 1-year implementation [...]