Washington Roundup – December 2024
By: Lowell Randel
Outlook for Continuing Resolution and Farm Bill Extension Unclear
On December 17th, Congressional leaders announced an agreement to fund the federal government until March 14th. The package, totaling over 1500 pages, includes a one-year extension of the 2018 Farm Bill as well as $100 billion in disaster relief and $10 billion in assistance to farmers. The legislation also includes funding and legislative language covering a wide variety of other programs and issues. The agreement has come under fire from President Trump, Elon Musk and others criticizing the breadth of additional provisions outside the extension of appropriations to avert a government shutdown. Trump has also suggested that Congress should use the vehicle to address the debt ceiling, which is expected to be hit early in 2025. Given the mounting opposition to the broad package, Congressional leaders are now exploring other options to keep the government funded into 2025, including a “clean” continuing resolution. Extending the 2018 Farm Bill before January 1st will be critical to avoid reverting to permanent law, with dairy programs the first to be impacted at the beginning of the year.
USDA and FDA Release Dietary Guidelines Committee Report
On December 10th, USDA and FDA jointly announced the availability of the Scientific Report of the 2025 Dietary Guidelines Advisory Committee on DietaryGuidelines.gov. The report contains the 2025 Dietary Guidelines Advisory Committee’s findings and advice to the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA). The report has been met with criticism from animal agriculture as it discounts the nutritional contributions of meat and recommends decreased intake of red meat and increased plant-based protein consumption. The report, alongside public comments and federal agency input, will inform the two departments as they develop the Dietary Guidelines for Americans, 2025-2030, which is expected to be published in late 2025.
FDA and APHIS Release Charter on Animal Biologicals Jurisdiction
On December 17th, the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) and the U.S. Food and Drug Administration (FDA) released a charter that details how the two agencies will work together to determine the appropriate agency to regulate animal biologicals for which jurisdiction may be unclear.
Representatives from APHIS and FDA originally signed a Memorandum of Understanding in 2013 (FDA MOU 225-05-7000) that outlined which animal biologicals each would regulate. Since 2013, science has continued to advance, and the jurisdiction of some products is not clear under the MOU. As regulatory science and the nature of animal biologicals have evolved over time, APHIS’ Center for Veterinary Biologics and FDA’s Center for Veterinary Medicine have worked together to develop a common approach, consistent with the law, for both agencies to make jurisdictional determinations on the regulation of products as either drugs under the Federal Food, Drug, and Cosmetic Act or biological products under the Virus-Serum-Toxin Act.
The charter includes a flowchart to help clarify which agency will regulate a given product, as well as information on how to request a jurisdiction determination from APHIS and FDA for animal biologicals. The charter also discusses the agencies’ approach for products with multiple claims where oversight may fall to both agencies and describes a reconsideration process for jurisdiction decisions.
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