In December 2023, the U.S. Food and Drug Administration (FDA) issued nine Warning Letters for the manufacture and distribution of unapproved over-the-counter (OTC) antimicrobial animal drugs for use in aquarium fish and...more
On September 26, 2023, the U.S. Environmental Protection Agency (EPA) requested comment on a proposed framework to strengthen the assessment of antimicrobial-resistance risks associated with pesticide use. EPA, the U.S....more
The U.S. Environmental Protection Agency (EPA) published an advanced notice of proposed rulemaking (ANPRM) on October 12, 2023, soliciting public comment and suggestions on specific issues related to seed treated with...more
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...more
By Heather F. Collins, M.S. and Lisa R. Burchi On July 17, 2023, the U.S. Environmental Protection Agency (EPA) announced the release of draft guidance for the evaluation of products for claims against viruses.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...more
On June 29, 2023, the U.S. Environmental Protection Agency (EPA) announced a new effort closing out notification actions for minor pesticide label or product formulation changes in an effort to reduce the backlog, which, EPA...more
The European Commission (EC) has just published its draft proposals to overhaul the European Union (EU) general pharmaceutical legislation. Tackling the problem of antimicrobial resistance was a key priority in the 2020...more
The U.S. Department of Agriculture (USDA) announced on April 11, 2023, that its Agricultural Research Service (ARS) recently developed sustainable, machine-washable antimicrobial wipes that can be used at least 30 times for...more
The Nanotechnology Industries Association (NIA) has posted a recording of its March 6, 2023, webinar on “Nano in Action: Antimicrobial Treatment.” The webinar explored a topic where relevance has been amplified by the...more
The U.S. Environmental Protection Agency (EPA) announced on May 11, 2022, that it is launching a new, modern Design for the Environment (DfE) logo that will appear on antimicrobial products like disinfectants and sanitizers...more
Concerns about the potential for antibiotic resistance started when they were first introduced as life-saving tools in human medicine. Despite such concerns, the importance of these tools for public and animal health have...more
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...more
Key Takeaways: • What Happened: EPA has indefinitely extended its activation of the emerging viral pathogens guidance for antimicrobial pesticides, permitting registrants with a pre-qualified “emerging viral pathogen...more
The International Organization for Standardization (ISO) recently published ISO/TS 23650:2021, “Nanotechnologies — Evaluation of the antimicrobial performance of textiles containing manufactured nanomaterials.” ISO states...more
On October 15, 2021, the U.S. Environmental Protection Agency (EPA) announced that it has revised its guidance for evaluating the efficacy of antimicrobial pesticides against Candida auris (C. auris). EPA states that...more
FDA issued an updated Q&A guidance in September 2021, Microbiological Considerations for Antimicrobial Agents Used in Food Applications: Guidance for Industry (Antimicrobial Agents Guidance), which replaces a guidance...more
On August 25, 2021, the U.S. Environmental Protection Agency (EPA) announced that it issued a penalty against Seychelle Environmental Technologies, Inc. (Seychelle), based in Aliso Viejo, California, for violations of the...more
Since the SARS-CoV-2 pandemic began, many companies have continued to develop antimicrobial products and devices to address health and safety concerns. Many of those companies are surprised to learn that the way in which they...more
FDA has continued to exercise its authority, via guidance documents, which FDA says, while not legally enforceable, represent the agencies current thinking on the topic. To further the judicious use of medically important...more
On July 2, 2021, the U.S. Environmental Protection Agency (EPA) announced it is taking action to alleviate a supply-chain issue facing the pesticide industry. EPA stated that it is allowing registrants of non-antimicrobial...more
FDA recently published Guidance #263 titled, “Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to...more
With everything that was happening this past winter, it would have been easy to miss the introduction of S. 4760: The PASTEUR Act. On December 9, U.S. Representatives Mike Doyle (D-PA) and Drew Ferguson (R-GA) introduced the...more
According to the Centers for Disease Control and Prevention (CDC) 2019 report Antibiotic Resistance Threats in the United States (“CDC Report”), “more than 2.8 million antibiotic-resistant infections occur in the United...more
On January 20, 2021, Health Care Without Harm (HCWH) Europe and 12 other health, environment, and justice organizations sent a letter to Bjorn Hansen, Executive Director of the European Chemicals Agency (ECHA) “seeking...more
On December 10, 2020, the U.S. Environmental Protection Agency (EPA) announced a new policy that will allow registrants of antimicrobial pesticide products voluntarily to disclose all inert ingredients more efficiently in...more