The U.S. Food and Drug Administration (“FDA”) issued three new rules on November 13 implementing the 2011 Food Safety Modernization Act. The Final Rule on Produce Safety establishes microbial water quality standards for water that is likely to have contact with produce and separate standards for purely irrigation water; establishes standards for raw manure and compost applied to crops to prevent contamination of produce; establishes rules to avoid contamination of produce by domesticated and wild animals; requires farm worker training on health and hygiene; and creates rules for tools, equipment and buildings to prevent contamination of produce.  The Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals requires importers of foreign food products into the United States to establish a program in place to verify that their foreign suppliers produce food in a manner that protects public health, avoids allergen misbranding, and prevents adulteration.  Importers will have to conduct a hazard analysis for all reasonably foreseeable health risks, evaluate each of their suppliers’ ability to minimize or prevent such hazards, establish and follow written procedures to ensure that they only import food from suppliers who minimize health risks, and verify foreign supplier compliance (by on-site audits of suppliers, by sampling and testing of a foreign supplier’s products, or by other means).  Importers have as little as 18 months to comply with the new rules. The Final Rule on Accredited Third-Party Certification establishes requirements and procedures for accrediting third-party certification bodies (or “auditors”) to conduct food safety audits and issue certifications of foreign facilities and foods produced by such facilities.  Among other things, the auditors will be required to perform unannounced facility audits and to notify the FDA of conditions posing a significant health risk.

For additional information regarding the new FDA rules, please contact Chip Magid via magid.chip dorsey.com.

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