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FDA moving forward with FSMA’s produce safety rule

foodsafetynews 2019-02-11
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When the FDA Food Safety Modernization Act (FSMA) was signed into law in 2011, one of the most challenging parts of Congress’ mandate was to transform the nation’s food safety system as it related to produce safety and implement a system of preventive controls that aimed to avert problems. At that time, U.S. produce farmers, and those in countries that export to the United States, had never been subject to this level of federal food safety oversight and, quite frankly, we at FDA had a lot to learn about the unique challenges farmers face every day. The idea of implementing preventive measures to head off food safety problems was a new and modern approach to regulation that promised to bring significant benefits for consumers.

The produce farming community is diverse, as are farming practices across our country and around the world. And, importantly, in the majority of cases, the farms are people’s homes. Knowing these challenges, FDA has invested many hours and resources, in partnership with the states, to pave a smooth path as we prepare for routine inspections. We’re pleased to affirm that routine inspections of the largest domestic and international farms, other than sprouts operations, will begin this spring.

Fresh produce is an important part of an overall healthy diet. The vast majority of fresh produce we eat is generally safe, especially when you consider per capita consumption rates. Unfortunately, in too many cases, foodborne illnesses are still being linked to fresh produce.

The Produce Safety Rule established under FSMA sets, for the first time, science-based standards for the safe growing, harvesting, packing and holding, of fruits and vegetables. In crafting this rule, and its series of preventive controls, we undertook an unprecedented amount of outreach, visiting farms and regulatory partners all over the world to get feedback and insights on the most effective and feasible ways to prevent produce contamination.

Even so, when the time came a year ago to begin routine inspections of large farms, other than sprouts operations (which have requirements specific to them), for compliance with the rule, we heard — and agreed — that more time was needed to ensure that produce farmers have the training and information they need to help them comply with the new requirements. We also wanted to give the states more time to establish strong produce regulatory programs. After all, states will be doing most of the routine inspections.

To achieve these goals, we postponed these large-farm inspections until the spring of 2019, except for certain potentially high-risk situations, such as ongoing outbreak investigations. We also determined that routine inspections of small farms, other than sprouts operations, subject to the Produce Safety Rule should not begin until Spring 2020. Their first major compliance date — January 28, 2019 – arrived a year after the corresponding compliance deadline for large farms.

With a few months to go before routine inspections begin for these large farms in the spring of 2019, we’d like to take this opportunity to let you know what we’ve been doing to support stakeholders’ work to comply with this rule and fulfill our promise to address some remaining needs before initiating the inspections. We’ve continued an intense effort to provide more resources to everyone involved in making these new standards a reality, including farms of all sizes, state and federal regulators, and cooperative extension agents.

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