All Knowledge & Insights By Date

By Lynn L. Bergeson and Carla N. Hutton   On April 25, 2023, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced that it published a new five-year strategic plan. According to APHIS, it incorporates input it received from stakeholders on the strategic framework, a summarized version of the plan that it published in June 2022. The plan includes six strategic goals that focus on working to: Protect agriculture from...

On February 22, 2023, the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) announced that it will co-host a virtual public meeting with the U.S. Food and Drug Administration’s (FDA) Center of Veterinary Medicine (CVM) on March 22, 2023. As stated in our February 17, 2023, blog, EPA and FDA are considering how best to update their respective oversight responsibilities for specific products in an efficient and...

On February 15, 2023, the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) and the U.S. Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) announced plans to seek public input on the best approaches for updating their respective oversight responsibilities for specific products. EPA states the goal is to determine responsibilities in an efficient and transparent manner and in alignment with each agency’s...

October 26, 202212:00 p.m. – 1:00 p.m. (EDT) The U.S. Food and Drug Administration (FDA) reports that 48 million people in the United States (1 in 6) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases. In 2011, President Obama signed into law the Food Safety Modernization Act (FSMA) in part to address this significant public health issue. FSMA is a comprehensive law intended to shift the focus of foodborne illness...

The U.S. Food and Drug Administration (FDA) will hold the “FDA NanoDay Symposium 2022” on October 11, 2022. The symposium will address the following topics: According to FDA, the intended audience includes:...

On August 19, 2021, the U.S. Environmental Protection Agency (EPA) announced a collaborative agreement with Unilever to explore better ways to assess chemical risks associated with consumer products. According to EPA, this agreement builds on prior cooperation between EPA and Unilever regarding New Approach Methods (NAM), “which are a promising alternative to conventional toxicity testing that are intended to reduce reliance on the use of animals.” EPA states that the collaboration...

On July 20, 2022, the Food and Drug Administration (FDA) published a request for information (RFI) to obtain data and information on the use of fluorinated polyethylene for food contact applications. 87 Fed. Reg. 43274. FDA states that it is seeking scientific data and information on current food contact uses of fluorinated polyethylene, consumer dietary exposure that may result from those uses, and the safety of certain per- and polyfluoroalkyl substances (PFAS) that may migrate from...

The National Nanotechnology Initiative (NNI) will hold a webinar on “What We Know about NanoEHS: Building International Bridges” on March 1, 2022. NNI states that it has supported the emergence of an international community of collaborative researchers on the environmental, health, and safety aspects of nanomaterials (nanoEHS). According to NNI, “[b]y advancing tools, methods, and standards for robust health and safety evaluation, these cooperative efforts have furthered the safe and...

The Food and Drug Administration (FDA) published a Federal Register notice on October 13, 2021, announcing the withdrawal of three guidance documents: “Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)”; “Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency”; and “Temporary Policy for Manufacture of Alcohol for Incorporation Into...

By Lynn L. Bergeson  On September 20, 2021, the U.S. Food and Drug Administration (FDA) announced the availability of its revised final guidance for industry on biosimilar development and the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). Titled “Questions and Answers on Biosimilar Development and the BPCI Act,” the revised guidance aims to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable...