The 42nd SQA Annual Meeting will cover “hot topics” in GCP, GLP, GMP, pharmacovigilance, scientific archiving, computer validation, veterinary medicine, and other QA disciplines. Lara A. Hall, MS, RQAP-GLP, Senior Regulatory Scientist and Quality Assurance Specialist, B&C, will present a poster titled "Navigating EPA GLP Advisories: Aligning with Current GLP Policy Interpretations and Compliance."
Archives
November 4, 2025
OECD Preparing Guidance on In Vitro Testing for Intestinal Fate of Orally Ingested Nanomaterials
The Organisation for Economic Co-operation and Development (OECD) has published a draft guidance document on in vitro testing for intestinal fate of orally ingested nanomaterials. According to OECD, the new guidance document “would establish a conceptual framework and procedures for determining intestinal fate of orally ingested nanomaterials using an integrated in vitro approach simulating the human [gastrointestinal tract] environment.” The primary objective of the draft guidance document...
On May 27, 2025, President Trump signed an Executive Order (EO) on “Restoring Gold Standard Science.” 90 Fed. Reg. 22601. The EO states that the Trump Administration “is committed to restoring a gold standard for science to ensure that federally funded research is transparent, rigorous, and impactful, and that Federal decisions are informed by the most credible, reliable, and impartial scientific evidence available.” The EO restores the scientific integrity policies of the first Trump...
February 7, 2025
Lynn L. Bergeson, Kelly N. Garson, and Lara A. Hall, “Testing, Testing,” Environmental Forum, March/April 2025.
A key force propelling reform of the Toxic Substances Control Act through Congress in 2016 was a bipartisan belief, shared by the business and environmental communities alike, that the Environmental Protection Agency needs more information to do its job of protecting the American public from adverse effects caused by chemical exposures. After all, it has been domestic policy under TSCA for almost a half century that “adequate information should be developed . . . and that the development of...
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 requirements of data...
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...
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,...
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) to address the use of the...
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...
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...