News Article

Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps to help produce farmers, processors more effectively comply with food safety requirements

Posted on October 26, 2018

Blog: Association of Food & Drug Officials (AFDO)

Please see today’s statement from FDA Commissioner Scott Gottlieb, M.D. on FDA’s new steps to help produce farmers, processors more effectively comply with food safety requirements:

Fruits and vegetables are a key part of a healthy diet. But because of the way produce is grown, handled and consumed – often raw – it can become contaminated with foodborne pathogens that may make consumers sick. Farmers understand the importance of food safety when they grow their crops. So did Congress when it passed the FDA Food Safety Modernization Act (FSMA). This law, for the first time, charged the FDA with establishing science-based standards for the safe production and harvesting of produce.


The resulting Produce Safety Rule requires domestic and foreign farms to put preventive measures in place during growing, harvesting, packing and holding of their fruits and vegetables. The goal is to protect these products from contamination. Another FSMA rule, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (the Preventive Controls rule), requires food facilities, such as fresh-cut produce processing plants that prepare bagged salad mixes or fruit salads, to have a food safety plan in place. These plans must include an analysis of hazards, and risk-based preventive controls to minimize or prevent those hazards. Prevention is the central aim of FSMA.


We understand that produce safety begins on the farm, but it doesn’t stop there. Everyone in the supply chain, from farm to table and in between, has an important role to play in food safety. Compliance by the produce industry with FSMA’s preventive controls is critical to achieving the public health benefits envisioned by the new law. And the FDA is committed to providing training and other support to farmers and produce processors to help achieve that goal.


Toward assisting farmers and processors in achieving these goals, today the FDA is releasing two new, draft guidance documents, one of which will help farmers better understand the range of steps they can take to comply with the Produce Safety Rule. The other will help processors better understand the relevant provisions of the Preventive Controls Rule for fresh-cut produce that apply to their practices.


To accommodate growing practices that vary by region and commodity, flexibility was built into the Produce Safety Rule. That flexibility is reflected in the new draft guidance document. The draft guidance for farmers, “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: Guidance for Industry,” gives examples of possible approaches to comply with the Produce Safety Rule to demonstrate how the rule might be implemented on different kinds of produce farms. It’s important to recognize that not every scenario is covered in the draft guidance, and farmers can always use an alternate approach as long as it satisfies the requirements of the Produce Safety Rule. But farmers can use the draft guidance as a guide to help evaluate their own on-farm practices.


See the link below for more information:

Constituent update:


Fresh cut guidance:


Produce Safety Rule guidance:


Produce Safety Rule guidance page with fact sheets.

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