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- USDA Announces Proposal to Regulate Agricultural Animal Biotechnology
USDA Announces Proposal to Regulate Agricultural Animal Biotechnology
December 23, 2020, Covington Alert
On December 21, 2020, the United States Department of Agriculture (USDA) released an Advanced Notice of Proposed Rulemaking (ANPR) to seek comment on a contemplated regulatory framework that, if finalized, would transition to USDA portions of the Food and Drug Administration’s (FDA’s) pre-existing animal biotechnology regulatory oversight.
In particular, USDA proposes to use its existing authorities under the Animal Health Protection Act (AHPA), the Federal Meat Inspection Act (FMIA), and the Poultry Products Inspection Act (PPIA) to provide end-to-end regulatory oversight from pre-market reviews through post-market food safety monitoring for livestock, horses, Siluriformes (including catfish) and poultry that are intended for agricultural purposes and that are modified or developed using genetic engineering. Under this framework, USDA’s Animal and Plant Health Inspection Service (APHIS) would conduct a safety assessment to ensure that the covered animals are not more susceptible to or more likely to transmit pests or diseases. The USDA’s Food Safety and Inspection Service (FSIS) would conduct a pre-slaughter food safety assessment to ensure that the slaughter and processing of these animals would not result in adulterated products.
This ANPR was developed in response to a June 2019 Executive Order on agricultural biotechnology, which directed federal agencies to modernize the regulatory framework for agricultural biotechnology products.
November 9, 2020, Covington Alert
Now that former Vice President Biden has been projected to win the 2020 U.S. Presidential Election, expect the transition to commence from the Trump Administration to a Biden Administration. Control of the U.S. Senate remains in the balance with two runoff elections in Georgia on January 5, but either way, the Senate majority will be razor thin and hence less ...
September 22, 2020, Covington Alert
Yesterday, FDA released a proposed rule that, if finalized, would impose additional traceability recordkeeping requirements for certain high-risk foods. This rulemaking is required by section 204 of FSMA, and is an additional action in FDA’s ongoing FSMA implementation. FDA proposes to establish a “Food Traceability List” (FTL) that would enumerate certain foods ...
September 15, 2020, Covington Alert
The first half of September has seen two major regulatory updates from USDA’s Food Safety and Inspection Service (FSIS). First, on September 14, 2020, FSIS published a proposed rule to expand the circumstances under which FSIS will generically approve the labels of meat, poultry, and egg products, which specifically proposes that FSIS will cease evaluating ...