December 18, 2017

December 15, 2017

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FDA Takes New Approach to Produce Safety

  • FDA’s Produce Safety Rule, implemented under the Food Safety Modernization Act (FSMA), establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption.  Our detailed summary of the rule is available here.

  • When the Produce Safety Rule became final in November 2015, FDA began building the Produce Safety Network (PSN) to support the efforts of farmers, state regulators and other key stakeholders to implement the rule.  The network is comprised of FDA produce safety experts, located in various locations throughout the country, and is staffed by seven produce safety experts and one team leader from the Center for Food Safety and Applied Nutrition (CFSAN), and 11 investigators and two branch chiefs from the Office of Regulatory Affairs (ORA). They work closely with key produce stakeholders, such as state produce safety programs, to provide regulatory support and technical assistance.  In particular, the PSN:

    • establishes regionally based policy and regulatory experts throughout the country, making them uniquely suited to address the issues specific to the states they’re supporting; and

    • places these experts, from two very different FDA offices, within one team. The network combines the regulatory expertise from the FDA’s Office of Regulatory Affairs (ORA) with the policy and science expertise from the Center for Food Safety and Applied Nutrition (CFSAN).

  • This week, FDA released an interview with Stephen Hughes, the PSN’s Team Lead from CFSAN and Brittany Laymon, one of two Branch Chiefs leading the investigators from ORA, discussing how the PSN works with industry to achieve FDA’s food safety and public health goals.  The complete interview is available here.  Of note, Hughes indicated that PSN investigators will be involved with domestic and foreign inspections.  Domestically, in states that do not have a produce safety program under the State Produce Implementation Cooperative Agreement Program (CAP), PSN intends to conduct routine and for-cause inspections. In states that do develop a produce safety program, FDA may accompany state inspectors during for-cause and routine inspections upon request.

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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