The FDA Needs to End Its Improper One-Size-Fits-All Approach to Produce Safety

Report Agriculture

The FDA Needs to End Its Improper One-Size-Fits-All Approach to Produce Safety

May 15, 2019 8 min read Download Report

Authors: Daren Bakst and Jeremy Dalrymple


Congress directed the Food and Drug Administration (FDA) to develop risk-based regulations for the production and harvesting of fruits and vegetables. The FDA, though, has instead taken a one-size-fits-all approach to produce safety, failing to take into account different risk levels across commodities. As a result, farmers who grow “non-risky” produce will have to unnecessarily comply with complex FDA regulations, and consumers will likely have to pay higher prices for that produce. The FDA needs to reverse course and follow the path that Congress laid out in law—to only regulate produce based on the risk associated with a given commodity.

Key Takeaways

The FDA’s produce safety regulation fails to account for the different risk levels for fruits and vegetables.

As a result, the FDA is ignoring legal requirements and regulating far more produce than warranted, likely driving up food prices, without adding to food safety.

The current Administration should revise the previous Administration’s misguided Produce Safety Rule—and should do so quickly.

In 2011, President Barack Obama signed the Food Safety Modernization ActREF into law. This sweeping federal law gave the Food and Drug Administration (FDA) the authority to regulate numerous areas of the food supply.

Produce safety is one of those regulated areas. Specifically, Congress directed the FDA to develop risk-based regulations for the production and harvesting of fruits and vegetables.REF However, the Obama Administration’s FDA ignored this risk-based approach when it finalized these regulations (the Produce Safety Rule).REF

Instead, the FDA chose to adopt a one-size-fits-all approach toward produce safety,REF regardless of whether there is a known or even a reasonable foreseeable risk of foodborne illness from specific types of produce.REF

The FDA’s implementation of the Produce Safety Rule is just starting to kick in.REF The FDA needs to reverse course and follow the path that Congress laid out in law.

The FDA’s Failure to Consider Different Levels of Risk

In 2015, the FDA stated that of the total produce-associated outbreaks from 1996 to 2014, 85 percent can be traced to just eight commodities (sprouts, leafy greens, tomatoes, melons, berries, herbs, cucumbers, and green onions).REF Sprouts alone accounted for about a quarter of the produce-related outbreaks.REF Despite this data, the FDA did not limit its regulation to these “risky”REF commodities, but instead decided to also regulate produce that has never even been associated with an outbreak.

The FDA has argued that a commodity should still be subject to regulation even if it has never been associated with an outbreak of foodborne illness—because at some point in the future it may be implicated in an outbreak. In its economic analysis of the proposed rule, the FDA explained that “it is likely that at least some commodities that currently have never been implicated in an outbreak have a positive probability of being implicated in a future outbreak.”REF A Mercatus Center report succinctly captured the absurdity of this logic: “This argument, if followed to its logical end, would not allow exemptions for any product for any health or safety rule ever.”REF

The Negative Impact of the FDA Ignoring Different Levels of Risk

As a result of failing to take into account different risk levels across commodities, farmers who grow “non-risky” produce will have to unnecessarily comply with prescriptive and complex FDA regulations covering issues like water testing and worker sanitation.REF

In its comment on the proposed rule, United Fresh, which represents the produce industry, argued: “By applying the same requirements to all commodities despite significant variation in risk profile across the vast diversity of fruits and vegetables, the Agency unnecessarily adds huge economic burdens on producers with little to no impact on risk reduction.”REF

Similarly, the American Farm Bureau Federation, in its comment on the proposed rule, urged the FDA to “reconsider standards that take into account the relative risks and comparative benefits associated with individual commodities.”REF

It is not merely farmers who will have to bear these unnecessary costs (estimated by the FDA to be over $350 million a year).REF Consumers will likely feel the brunt of this agency overreach through higher food prices.

From a food safety perspective, covering “non-risky” produce diverts the FDA’s attention away from addressing where the risks actually may exist. This approach does not help food safety efforts; in fact, it may very well undermine them.


While the Obama Administration’s FDA might have ignored Congress and its desire for risk-based regulation, the Trump Administration’s FDA should do what agencies across the federal government have recently done: Respect the rule of law and the plain language of statutes.

The agency should revise the Produce Safety Rule to reflect what the law actually says, not what the bureaucrats would like it to say. This would include:

  • Considering risk. The FDA should follow the law and revise its rule to regulate only those fruits and vegetables for which there is an actual risk of foodborne illness.
  • Limiting regulation to produce with previous outbreaks. The best way to determine if a fruit or vegetable poses a risk is to examine whether there has been an outbreak. This approach provides a clear and objective way for the agency to determine the “risky” commodities.
  • Updating the list of “risky” produce. The list of regulated produce should not be set in stone. Just because there has been an outbreak in the past for specific produce does not necessarily mean that this produce should be regulated indefinitely. After a sufficient period of time has elapsed without an outbreak (such as 10 years), the FDA should remove that produce from the “risky” list.REF Some limited exceptions might be appropriate, such as if peer-reviewed research clearly demonstrates that the risk of foodborne illness remains. This updating process would work the other way as well: Produce that has a new outbreak should be added to the “risky” list.
  • Ensuring that the risk is connected to on-farm practices. Congress directed the FDA to address produce safety issues connected to on-farm practices. Outbreaks, even if they can be shown to be caused by a specific commodity, could be the result of off-farm activities, such as transportation, retail practices, or actions taken by the consumer. The FDA should not use the off-farm contamination of produce as justification for controlling on-farm practices.

Regardless of whether the FDA makes these changes, Congress, at a minimum, should amend the Food Safety Modernization Act in order to leave no doubt that the FDA may only regulate produce safety based on the risk connected with specific commodities.


The Food Safety Modernization Act is a law that seeks to prevent food contamination, not respond to it. However, the FDA is not preventing foodborne illnesses by regulating “non-risky” fruits and vegetables. It is instead ignoring the law, unnecessarily intervening in farming practices, and likely driving up food prices for consumers. There is a window of opportunity for the current Administration’s FDA to get things right before the previous Administration’s Produce Safety Rule goes into full effect. This opportunity should not be lost.

—Daren Bakst is Senior Research Fellow in Agricultural Policy in the Thomas A. Roe Institute for Economic Policy Studies, of the Institute for Economic Freedom, at The Heritage Foundation. Jeremy Dalrymple is a Research Associate in the Roe Institute.


Daren Bakst
Daren Bakst

Former Senior Research Fellow

Jeremy Dalrymple
Jeremy Dalrymple

Former Research Associate, Thomas A. Roe Institute