Archives

August 14, 2024

Ensuring Data Quality and Compliance to Support Global Antimicrobial Registrations, September 25, 2024, 12:00 p.m. – 1:00 p.m. (EDT), via webinar

Lara A. Hall, Senior Regulatory Scientist/Quality Assurance Specialist, B&C, and Michelle C. Mims, Regulatory Scientist/Quality Assurance Specialist, B&C, are pleased to present “Ensuring Data Quality and Compliance to Support Global Antimicrobial Registrations” during the Household & Commercial Products Association’s (HCPA) Antimicrobial Regulatory Frameworks Across the Globe Webinar Series. This session will explore the overarching quality and compliance...
June 6, 2024

New Date – June 13, 2024 – “Sponsor’s Role in Regulatory Testing” Webinar; Registration Open

Please note that the date of this webinar has moved forward one day, from Wednesday, June 12, 2024, to Thursday, June 13, 2024, 11:00 a.m. – 12:00 p.m. (EDT). Register now to join Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®) for “Sponsor’s Role in Regulatory Testing — Complying with GLP Standards,” a complimentary webinar covering the roles and responsibilities of Study Sponsors, as defined by Good Laboratory Practices (GLP) regulations and related...
March 7, 2024

EPA Releases New Methodology to Detect Low Levels of PFAS in HDPE Containers

On February 15, 2024, the U.S. Environmental Protection Agency (EPA) announced the release of a new methodology for detecting 32 per- and polyfluoroalkyl substances (PFAS) in high-density polyethylene (HDPE) containers. According to EPA, the method can accurately identify PFAS contamination at levels as low as 0.002 parts per billion (ppb) (or 2 parts per trillion (ppt)). EPA states that in releasing this method to the public, it “is enabling the industries that utilize HDPE containers,...
February 5, 2024

EPA Releases Draft 6PPD-Quinone Water Testing Method for Widespread Use

The U.S. Environmental Protection Agency (EPA) announced on January 30, 2024, the publication of a draft testing method (EPA Method 1634) that will enable government agencies, Tribes, and other groups to determine where and when 6PPD-quinone is present in local stormwater and surface waters. As reported in our November 3, 2023, blog item, on November 2, 2023, EPA announced that it granted a petition filed under Section 21 of the Toxic Substances Control Act (TSCA)...
September 5, 2023

EPA Announces Release of Final Guidance and Methods to Control Public Health Pathogens on Soft Surface Textiles in Non-Residential Settings

On August 29, 2023, the U.S. Environmental Protection Agency (EPA) announced the release of final guidance and methods for evaluating efficacy claims of antimicrobial products registered to reduce bacteria and viruses on soft surface textiles. EPA states that throughout the guidance, the term “soft surface textile” refers to a soft, porous, or non-porous surface that includes the outer surface of non-clothing fabrics/textiles in clinical and...
August 10, 2023

EPA Announces New Webinar Series on the Use of NAMs to Reduce Animal Testing

The U.S. Environmental Protection Agency (EPA) is launching a webinar series in collaboration with the PETA Science Consortium International (PSCI), Institute for In Vitro Sciences (IIVS), and the California Department of Pesticide Regulation (CDPR). According to EPA, the quarterly series will focus on the use of new approach methodologies (NAM), or alternative methods to reduce vertebrate animal testing, for risk assessment within EPA and CDPR. The first webinar in the series will take place...
August 10, 2023

EPA Announces New Webinar Series on the Use of NAMs to Reduce Animal Testing

The U.S. Environmental Protection Agency (EPA) is launching a webinar series in collaboration with the PETA Science Consortium International (PSCI), Institute for In Vitro Sciences (IIVS), and the California Department of Pesticide Regulation (CDPR). According to EPA, the quarterly series will focus on the use of new approach methodologies (NAM), or alternative methods to reduce vertebrate animal testing, for risk assessment within EPA and CDPR. The first webinar in the series will take place...
June 19, 2023

EPA Announces Release of Guidance for the Evaluation of Products for Claims against Viruses

On July 17, 2023, the U.S. Environmental Protection Agency (EPA) announced the release of draft guidance for the evaluation of products for claims against viruses. This new guidance provides the framework for registrants who seek to make virucidal claims for antimicrobial products. This draft guidance reiterates recommended test methods and regulatory guidance for the addition of virucidal claims to products that meet the criteria for hard surface disinfection claims...
June 1, 2023

SCCS Updates Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation

The European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) published on May 16, 2023, the 12th revision of The SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation. The guidance contains information on the different aspects of testing and safety evaluation of cosmetic substances in Europe. The emphasis of the guidance is on cosmetic ingredients, but it notes that “some guidance is also indirectly given for the safety assessment of...
April 11, 2023

Paper Proposes Further Actions to Harmonize Testing of Nanomaterials for EU Regulatory Requirements

On April 6, 2023, NanoHarmony announced publication of a paper in Regulatory Toxicology and Pharmacology entitled “Towards harmonisation of testing of nanomaterials for EU regulatory requirements on chemical safety — A proposal for further actions.” The paper provides an overview of the information requirements across different European Union (EU) regulatory areas. For each information requirement, experts identified potential needs for further action to accommodate...