The U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA) announced today a formal-agreement coordinating joint jurisdiction over the production of products derived from cell lines of livestock and poultry. This agreement marks the next significant step in establishing the regulatory framework for these products and
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USDA’s AMS Issues Final Rule on National Bioengineered Food Disclosure Standard
By Martin Hahn & Veronica Colas on
Yesterday the U.S. Department of Agriculture’s (USDA’s) Agricultural Marketing Service (AMS) released its final rule implementing the National Bioengineered Food Disclosure Standard (NBFDS) passed by Congress in July 2016. In this post we summarize the top ten key highlights of the final rule.
USDA and FDA Announce Joint Oversight Over Cell Cultured Products
By Gary Kushner, Brian Eyink & Mary Lancaster on
On Friday, November 16, 2018, the U.S. Department of Agriculture (USDA) Secretary Perdue and U.S. Food and Drug Administration (FDA) Commissioner Gottlieb announced a joint regulatory framework to oversee cell cultured products. Under the proposed framework, FDA plans to oversee cell collection, cell banks, cell growth, and cell differentiation. USDA will oversee cell harvest, production,…
USDA Sends National Bioengineered Food Disclosure Standard to OMB While Facing Lawsuit for Failing to Meet Statutory Deadline
By Martin Hahn, Veronica Colas & Leigh Barcham on
On August 1, 2018, two consumer groups sued the U.S. Department of Agriculture (USDA), USDA Secretary Sonny Perdue, and Agricultural Marketing Service (AMS) Administrator Bruce Summers for failing to meet the statutory rulemaking deadlines for the National Bioengineered Food Disclosure Standard (NBFDS). The suit was filed by the Center for Food Safety (CFS) and Center…
FSIS Issues Guidance on Retailer and Restaurant Exemptions from Inspection Under the Federal Meat Inspection Act
By Gary Kushner, Brian Eyink & Samantha Dietle on
The U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) recently released a guidance document to help companies determine whether their operations are exempt from the inspection requirements of the Federal Meat Inspection Act (FMIA). This guidance marks FSIS’s first significant attempt to articulate policy addressing the applicability of its retailer and restaurant…
USDA’s AMS Issues Proposed Rule on National Bioengineered Food Disclosure Standard
By Martin Hahn & Veronica Colas on
On May 3, the U.S. Department of Agriculture’s (USDA’s) Agricultural Marketing Service (AMS) issued its proposed rule implementing the National Bioengineered Food Disclosure Standard (NBFDS) passed by Congress in July 2016. AMS is proposing a crop-based approach, where disclosure would be required when a food is or contains a crop, or a derivative of a…
FDA Finalizes Extension of Compliance Date for Nutrition Labeling Final Rules
The Food and Drug Administration (FDA) has issued a final rule extending the compliance date for the final rules revising the requirements for the nutrition and supplement facts labels and the declared serving sizes and reference amounts customarily consumed (RACCs). The final rule extends the compliance date for manufacturers with $10 million or more in…
USDA Withdraws Final Rule on Organic Livestock and Poultry Practices
By Steve Steinborn, Brian Eyink & Christine Forgues on
The United States Department of Agriculture (USDA) Agricultural Marketing Service (AMS) recently issued a final rule withdrawing the Organic Livestock and Poultry Practices (OLPP) Final Rule published in the Federal Register on January 19, 2017. The OLPP rule promised to impose various animal handling and raising requirements on livestock and poultry labeled Organic, but it…
FDA and USDA Announce Agreement on Cooperation and Coordination
By Joe Levitt, Brian Eyink & Leigh Barcham on
U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., and U.S. Department of Agriculture (USDA) Secretary Sonny Perdue announced a formal agreement on January 30, 2018, intended to increase coordination and collaboration between the two agencies. The high-level agreement is limited on details, but includes commitments to developing interagency working groups for the following…
OMB Issues Additional Guidance on Implementation of Executive Order 13771 and the Government-wide Reform Plan
By Joe Levitt, Leigh Barcham & Samantha Dietle on
Earlier this spring, the White House Office of Management and Budget (OMB) issued additional guidance for agencies on implementing Executive Order (EO) 13771, entitled “Reducing Regulation and Controlling Regulatory Costs.” EO 13771 established the expectation that for every new regulatory action an agency issues, it must offset the cost of the regulatory action with two…