The Food and Drug Administration will soon be micromanaging a wide range of farming-related activities for many farms.

In 2011, President Barack Obama signed into law the Food Safety Modernization Act, which impacts numerous areas of the food supply, including produce safety.

The FDA finalized a FSMA produce safety rule in 2015, with most of the major requirements kicking in over the next several years. 

Unfortunately, the FDA ignored the law’s express requirements to develop a risk-based rule.

Under FSMA, the FDA is required to develop science-based minimum standards for the production and harvesting of fruits and vegetables that are raw agricultural commodities.  In determining what produce should be covered, Congress required the FDA to cover produce that have known risks.

So what did the FDA do in its final produce safety rule?  It ignored the known risk requirement.

The rule doesn’t require a commodity to be connected to a foodborne illness outbreak in order to be regulated, or even to be similar to the small number of produce commodities that are connected to outbreaks. 

The FDA has taken the view that because an outbreak is possible, regardless of the likelihood, that’s sufficient.    As explained by the FDA, “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.”

By this logic, except for the limited exceptions that exist in the rule, no produce is safe from the regulatory reach of the FDA. 

The FDA isn’t taking a broad interpretation of FSMA’s language; instead, it is ignoring FSMA’s language and doing the exact opposite of what Congress intended.

By regulating more fruits and vegetable, the FDA has also given itself the ability to enforce its produce safety rule requirements on a far greater number of farmers.  These standards cover a wide range of issues that address potential on-farm sources of contamination from water quality and testing to sanitation of equipment, tools, and buildings.

If this weren’t bad enough, it isn’t the only major problem with the rule. The FDA is applying a one-size-fits-all mentality, enforcing standards that have no relevance for numerous commodities.

If there’s going to be federal produce safety regulations, there are several changes that need to be made, including:

  1. A commodity should be required to have a known risk.  This should mean the commodity is connected to an outbreak that was caused by an on-farm activity.  This is critical because the cause of an outbreak could have nothing to do with a farm.  For example, contamination may be caused by the transportation of a commodity or something that happened in a retail or home setting.
  2. The FDA shouldn’t have a static list of regulated produce.  If a commodity hasn’t had an outbreak in 10 years, it shouldn’t be regulated.
  3. The science-based minimum standards should only be imposed on a commodity to address known risks for that commodity.
  4. There should be peer-reviewed risk assessments and the benefits should outweigh the costs.

The FDA needs to change course by rescinding the rule and developing a new rule consistent with the requirements of FSMA.  Congress should also take action to ensure that this overreach doesn’t happen again.

Congress didn’t want the FDA, which knows little about farming, to be developing intrusive rules.  Congress wanted a risk-based approach based on sound science, not a “shotgun” approach to regulate almost all produce. 

About the Author: Daren Bakst is a research fellow in agricultural policy in the Thomas A. Roe Institute for Economic Policy Studies at The Heritage Foundation (