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

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Toward assisting farmers and processors in achieving these goals, today the FDA is releasing two new, draft guidance documents, one of which will help farmers better understand the range of steps they can take to comply with the Produce Safety Rule.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 That flexibility is reflected in the new draft guidance document. The draft guidance for farmers, “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: Guidance for Industry,” gives examples of possible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.

As we continue to implement FSMA, we recognize that one of the keys to success is stakeholder awareness, understanding and compliance with the new standards. To that end, the FDA has also published “At-A-Glance” overviews of each chapter in the draft Produce Safety Rule guidance. These overviews highlight the key points as well as a glossary of the key terms. We’re also announcing today that we’ll hold four public meetings around the country to introduce and get feedback on the draft Produce Safety Rule guidance. Stakeholders will have the opportunity to discuss food safety practices with FDA experts. We’ll announce the dates and locations of these meetings soon via a notice in the Federal Register.

The second draft guidance document released today, “Guide to Minimize Food Safety Hazards of Fresh-cut Produce,” discusses how fresh-cut produce processors may comply with recently modernized requirements for current good manufacturing practices (CGMP) and with new requirements for hazard analysis and risk-based preventive controls. Fresh-cut fruits and vegetables are those that have been physically altered (e.g., chopped, diced, peeled, shredded, sliced, etc.) after being harvested without additional processing, such as cooking, that could kill potentially dangerous bacteria. This draft guidance, when finalized, will replace the 2008 guidance, “Guide to Minimize Microbial Food Hazards of Fresh-cut Fruits and Vegetables.” The aim is to give producers more up-to-date guidance.

Stakeholder input and feedback has been a critical part of the FSMA implementation process. And we’re committed to hearing all perspectives. Our aim is to ensure that the guidance we put in place will help industry comply with the new food safety standards and achieve the goal of producing safer produce.

Public comments will help us ensure that the recommendations contained within the two new draft guidance documents are effective and practical. Although you can comment on the draft guidances at any time, you should submit your comments by April 22, 2019, to ensure that we consider your comments before we begin work on the final versions of the guidances. We remain committed to helping ensure that fruits and vegetables -- whether whole or prepared as fresh-cut produce -- are safe for consumers. This starts with helping farmers and fresh-cut produce processors, at home and abroad, meet FSMA’s food safety standards. We’ll continue to collaborate with stakeholders as we implement FSMA to ensure that our nation has one of the safest food supplies in the world.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

FDA and USDA announce key step to advance collaborative efforts to streamline produce safety requirements for farmers

 

From FDA News, June 5, 2018: 

As part of the U.S. Food and Drug Administration and the U.S. Department of Agriculture’s ongoing effort to make the oversight of food safety stronger and more efficient, the FDA and the USDA today announced the alignment of the USDA Harmonized Good Agricultural Practices Audit Program (USDA H-GAP) with the requirements of the FDA Food Safety Modernization Act’s (FSMA’s) Produce Safety Rule.

The new step is part of an ongoing effort to streamline produce safety requirements for farmers. The joint announcement was made by Agriculture Secretary Sonny Perdue and FDA Commissioner Scott Gottlieb, M.D., during a visit by the Secretary to the FDA’s White Oak campus in Silver Spring, Md.

“Government should make things easier for our customers whenever possible and these important improvements help accomplish that goal,” said Secretary Perdue. “Specialty crop farmers who take advantage of a USDA Harmonized GAP audit now will have a much greater likelihood of passing a FSMA inspection as well. This means one stop at USDA helps producers meet federal regulatory requirements, deliver the safest food in the world and grow the market for American-grown food. This is an important first step. We look forward to continuing to work with FDA, other government agencies and especially our state partners to ensure proper training of auditors and inspectors, and to help producers understand changes in the audit.”

While the requirements of both programs are not identical, the relevant technical components in the FDA Produce Safety Rule are covered in the USDA H-GAP Audit Program. The aligned components include areas such as biological soil amendments; sprouts; domesticated and wild animals; worker training; health and hygiene; and equipment, tools and buildings. The alignment will help farmers by enabling them to assess their food safety practices as they prepare to comply with the Produce Safety Rule. However, the USDA audits are not a substitute for FDA or state regulatory inspections.

“We’re committed to working with USDA to pursue our shared goal of advancing food safety in a way that is efficient and helps farmers meet our regulatory standards. By working together, our two programs can advance these efforts more effectively,” said Commissioner Gottlieb. “Today’s announcement will help FDA and states better prioritize our inspectional activities by using USDA H-GAP audit information to prioritize inspectional resources and ultimately enhance our overall ability to protect public health. Inspections are key to helping to ensure that produce safety standards are being met, but they only provide a snapshot in time. Leveraging the data and work being done by USDA will provide us with more information so that we can develop a clearer understanding of the safety and vulnerabilities on produce farms as well as concentrate our oversight and resources where they are most needed.”

The Produce Safety Rule, which went into effect on Jan. 26, 2016, establishes science-based minimum standards for the safe growing, harvesting, packing and holding of fruits and vegetables grown for human consumption. The rule is part of the FDA’s ongoing efforts to implement FSMA. Large farming operations were required to comply with the rule in January 2018. However, the FDA had previously announced that inspections to assess compliance with the Produce Safety Rule for produce other than sprouts would not begin until Spring 2019. Small and very small farms have additional time to comply.

The USDA Harmonized GAP Audit Program is an audit developed as part of the Produce GAP Harmonization Initiative, an industry-driven effort to develop food safety GAP standards and audit checklists for pre-harvest and post-harvest operations. The Initiative is a collaborative effort on the part of growers, shippers, produce buyers, audit organizations and government agencies, including USDA. The USDA Harmonized GAP audit, in keeping with the Initiative’s goals, is applicable to all fresh produce commodities, all sizes of on-farm operations and all regions in the United States. For more information visit: https://www.ams.usda.gov.

Today’s announcement builds on a formal agreement signed earlier this year outlining plans to increase interagency coordination regarding produce safety, inspections of dual-jurisdiction facilities and biotechnology activities. The FDA and USDA are committed to continuing to work collaboratively to ensure that the requirements and expectations of the USDA H-GAP Audit Program remain aligned with the FDA’s Produce Safety Rule.

Farmers who are interested in learning more about this alignment and what they can do to prepare for compliance with the Produce Safety Rule can contact their regional representative of the Produce Safety Network or find more information at FDA.gov.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

The U.S. Department of Agriculture (USDA) is made up of 29 agencies and offices with nearly 100,000 employees who serve the American people at more than 4,500 locations across the country and abroad. We provide leadership on food, agriculture, natural resources, rural development, nutrition, and related issues based on public policy, the best available science, and effective management. We have a vision to provide economic opportunity through innovation, helping rural America to thrive; to promote agriculture production that better nourishes Americans while also helping feed others throughout the world; and to preserve our nation's natural resources through conservation, restored forests, improved watersheds, and healthy private working lands.

 

 

Do You Still Qualify for a FSMA Exemption? FDA Updates Inflation Adjusted Cut-Offs

Most of the final rules implementing the FDA Food Safety Modernization Act (FSMA) have compliance dates or exemptions that are based on annual sales averaged over the previous three-year period and adjusted for inflation. These baseline values were set in 2011, when FSMA became law, but have changed every year because of inflation. The FDA has updated the applicable inflation adjusted values for six of the FSMA regulations covering 2015-2017, the most recent three years for which these values are available.

These values are particularly noteworthy for smaller businesses that may not be covered, may receive an exemption, or have later compliance dates based on their sales being less than the indicated value. For instance, farms or farm mixed-type facilities with an average annual monetary value of produce sold during the previous 3-year period of $25,000 or less (adjusted for inflation) are not subject to the Produce Safety Rule. That number, $25,000, was set as the baseline in 2011, however, the three-year inflation-adjusted average from 2015-2017 is $26,999. Therefore, if a farm or farm mixed-type facility’s three-year average is $26,999 or less, it is not subject to the Produce Safety Rule.  

Certain businesses subject to the Preventive Controls for Human Food, Preventive Controls for Animal Food, Produce Safety, Foreign Supplier Verification Programs, Sanitary Transportation and Intentional Adulteration Regulations should refer to the updated values at the FSMA Inflation Adjusted Cut Offs page to determine whether they meet the cut-off value for the applicable regulation.

FDA Issues Guidance For Industry on the Importation of Certain Live Animals

The U.S. Food and Drug Administration (FDA) has issued a guidance today explaining that FDA intends to exercise enforcement discretion regarding the application of the Foreign Supplier Verification (FSVP) rule to importers of certain live animals.

This guidance can be read on FDA's website, and applies to live animals that must be slaughtered and processed at establishments regulated by USDA and subject to USDA-administered hazard analysis and critical control point (HACCP) requirements (or at State-inspected establishments subject to requirements equivalent to the federal standards).  This means the agency does not intend to enforce the FSVP requirements that these importers would otherwise have to meet. This intent to exercise enforcement discretion accounts for the role of another Federal agency with regards to these animals. This is also consistent with the exemption in the FSVP rule for certain USDA-regulated products. 

Read the full guidance for industry here.  

FDA Releases Compliance Guide for Small Businesses under FSMA Produce Safety Rule

September 5, 2017

Small Entity Compliance Guides (SECGs) are designed to help small businesses meet federal standards. They are among the resources that the FDA is providing to support compliance with the new FDA Food Safety Modernization Act (FSMA) standards.

The FDA announced today the availability of an SECG to help small businesses comply with the Produce Safety Rulemandated by FSMA.

The SECG provides information that can help small and very small businesses understand how the requirements of the Produce Safety Rule apply to them. Specifically, the SECG can help farmers determine whether they are eligible for a qualified exemption, which would modify the requirements they are subject to under the Produce Safety Rule. The SECG can also help them understand those modified requirements.

The SECG was prepared in accordance with the Small Business Regulatory Enforcement and Fairness Act. The main compliance dates for small businesses and very small businesses under the Produce Safety Rule are January 28, 2019, and January 27, 2020, respectively, but certain agricultural water requirements have extended compliance dates. Sprout operations also have different compliance dates, and sprout operations that are small businesses and very small businesses have compliance dates of January 26, 2018, and January 28, 2019, respectively. Businesses that intend to claim a qualified exemption by their primary compliance date were required to begin keeping documentation supporting their eligibility for a qualified exemption on January 26, 2016.

Visit FDA.gov/FSMA for more information about the FSMA rules and compliance dates.