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  1. FDA Voices

Paving the Road to Produce Safety Rule Inspections

By: Scott Gottlieb, M.D., Frank Yiannas, MPH, and Melinda Plaisier, MSW

FDA Commissioner Scott Gottlieb, M.D.
Scott Gottlieb, MD

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.

FDA Deputy Commissioner for Food Policy and Response Frank Yiannas, MPH
FDA Deputy Commissioner for Food Policy and Response Frank Yiannas, MPH

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.

Helping the States

FDA Associate Commissioner of Regulatory Affairs Melinda Plaisier, MSW
FDA Associate Commissioner of Regulatory Affairs Melinda Plaisier, MSW

FDA has granted 46 states and one territory more than $85 million through the State Produce Implementation Cooperative Agreement Program (CAP). These funds are being used to develop state produce safety systems that will provide education, outreach and technical assistance to meet the unique needs of their produce farming communities.

Most states opted to also use this funding to conduct produce farm inspections. A key goal for FDA’s CAP program is creating an inspectional system in which the state experts who are most familiar with local farming practices conduct the bulk of inspections. FDA will also be doing inspections. But our resources will be focused on inspections in states that didn’t sign up for the CAP inspections, conducting foreign produce inspections, and working with state partners in certain “for cause” inspections, like those conducted during an outbreak investigation.

Providing Training

With our support, the Produce Safety Alliance and the Produce International Partnership for Education and Outreach, have led efforts to train more than 31,000 produce farmers around the world on the requirements of the Produce Safety Rule. We’ll continue to provide training to FDA staff and state partners who perform produce farm inspections. We’ve also provided training for state cooperative extension agents who are recognized by the farming community as a source for valuable information and resources for farms in their regions.

Issuing Guidance

Last October, we published the draft compliance and implementation guidance for the Produce Safety Rule, along with fact sheets highlighting key information in each chapter. When finalized, the draft guidance will provide FDA’s recommendations to help produce farmers understand how to develop their own food safety practices that comply with the Produce Safety Rule. We have conducted four public meetings to discuss the draft guidance with stakeholders. These resources are available at fda.gov.

Sharing Expertise

Our Produce Safety Network staff continues to work with states and other stakeholders to implement our national produce regulatory system.

Located throughout the country, these produce safety experts and specialized investigators provide localized regulatory and technical assistance. Basing produce safety staff in specific growing regions allows them to develop a deep understanding of and expertise in the growing practices and conditions unique to their area and the produce grown there.

Reviewing Readiness

The National Association of State Departments of Agriculture (NASDA), with FDA participation, has developed and implemented the On-Farm Readiness Review (OFRR) program. These voluntary reviews are designed to help produce farmers determine how prepared they are to comply with the Produce Safety Rule and to provide specific recommendations for improving their operation and implementing good practices. More than 350 farms have had this evaluation thus far. These reviews will continue to be available even as inspections begin.

Creating Specialized Inspectional Forms and Procedures

FDA, NASDA, and our state partners, have collaborated to develop a new inspection form to provide feedback to farms and document observations. This form — called FDA 4056/Produce Farm Inspection Observations — was designed around the specific provisions in the Produce Safety Rule. As produce inspections begin, we’ll pilot this as an alternative to our traditional inspectional form - FDA 483, used in inspections of food manufacturing facilities.

Farms are different and require a different approach. This form has been made available to our state partners for their use in produce regulatory programs. FDA will issue the new form at the end of every farm inspection, whether or not any non-compliance issues were identified, to explain what’s being examined and how any observation relates to the regulation.

Additionally, we’ve created a fact sheet with NASDA outlining for stakeholders what they can expect from a regulatory inspection. This resource is provided to produce farmers and other stakeholders to help clarify the steps/processes for what will happen before, during, and after an inspection. Produce farmers may not have experienced a food safety regulatory inspection before. These resources are designed to help farmers meet our shared goals and standards.

For more information about, and links to, these resources, we’ve created a new Produce Inspections web page at fda.gov. This page serves as a central location for our stakeholders and state partners to find resources as they make their final preparations for the start of routine inspections this spring. The importance of our efforts to achieve high rates of compliance with the new produce standards is underscored by the outbreaks of foodborne illness we’ve seen recently in fresh produce. We understand the important role fresh produce plays in an overall healthy diet. To advance these goals, we want to further strengthen the safeguards and the confidence that consumers have in these products, which are vital to our well-being. We’ll continue to educate while we regulate and look for knowledge gaps. And we’ll provide resources necessary to help stakeholders in the produce industry protect the public from foodborne illnesses.


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