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Enforcement Discretion to be Exercised for FSMA Regulatory Provisions

Monday, January 08, 2018
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration has announced its intent to not enforce certain provisions in four rules issued under the Food Safety Modernization Act concerning preventive controls for human and animal food, the foreign supplier verification program for importers of such food, and produce for human consumption. FDA Commissioner Scott Gottlieb said this enforcement discretion is designed to allow the agency to address certain challenges with implementing FSMA requirements as it works to find long-term solutions. The FDA had previously extended the compliance dates for many of these same provisions in recognition of these challenges.

The provisions the FDA does not intend to enforce relate to the following.

- preventive controls and current good manufacturing practices requirements in the human and animal food rules for foreign and domestic facilities that conduct activities typically conducted on farms but that fall outside the current definition of farm (e.g., facilities that would qualify as farms if they did not color raw agricultural commodities, or as secondary activities farms except for (a) the ownership of the facility or (b) the fact that they pack, package, label, and/or hold processed food that consists only of raw agricultural commodities that have been dried or dehydrated to create a distinct commodity)

- customer provisions in all four rules intended to provide written assurance to importers, manufacturers, processors, or farmers that the food will be processed to control for hazards before it reaches consumers

- foreign supplier verification programs for importers of food contact substances

- activities performed on certain human food byproducts for use as animal food

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