New FDA Produce Safety Rule Exemptions

AMES, Iowa – The Food Safety Modernization Act signed into law in January 2011 addressed improvements needed to the U.S. food supply. One proposed section to the law addresses the safety of fresh produce by defining new produce standards for foods often consumed in raw form.

“Also identified by the Food and Drug Administration in this section are foods not typically consumed in raw form such as eggplant, lentils or sweet potatoes,” said Catherine Strohbehn, food safety specialist with Iowa State University Extension and Outreach. “These standards are in addition to the Bioterrorism Act of 2002 which continues and requires food facilities to follow preventative control rules and register with FDA.”

New definitions in proposed regulations
Under these new proposed regulations, growers need to be aware of new definitions, said Strohbehn. The proposed rule would define “farm” to mean a facility in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood) or both.

“Farm” includes (i) facilities that pack or hold food, provided that all food used in such activities is grown, raised, or consumed on that farm or another farm under the same ownership; and (ii) facilities that manufacture/process food, provided that all food used in such activities is consumed on that farm or another farm under the same ownership.

A broad definition of food is used – thus any item grown or produced on a farm that is ultimately intended for human consumption is considered a food.

"This includes seeds, soybeans and livestock, not just produce sales," said Angela Shaw, extension food safety specialist. "This also includes prepared foods such as pies and cookies that might be sold with farm-grown produce at a roadside stand."

Three categories of farm exemptions are defined. These exemptions apply to very small and small businesses. When estimating a farm’s average annual sales, farmers must include ALL defined food sources. Farms with three-year average annual sales for all defined food types going to any vendor of $25,000 or less are exempt as they are considered very small businesses.

Those farms with $300,000 or less with defined food types going to any vendor are exempt also as they are classified as small businesses. For example, a soybean grower for human consumption (annual sales of $300,000) with a small produce road side stand ($10,000) would total all the sales amounts ($310,000) and would no longer be exempt from this proposed ruling.   

The third category of exemptions applies to whether a qualified end-user is sold the product during the previous three-year period preceding the applicable calendar year: The average annual monetary value of the food sold directly to qualified end-users during such period exceeded the average annual value of the food sold to all other buyers during that period; AND The average annual monetary value of all food sold during such period was less than $500,000, adjusted for inflation.  

A qualified end user is defined as (a) a consumer of the food or (b) a restaurant or retail food establishment located within the same state as the farm that produced the food or not more than 275 miles from such farm. For example, a farm operation in Iowa selling a three-year average of $300,000 dollars’ worth of food to a restaurant or food establishment less than 275 miles from the farm and which also sold $100,000 at farmers’ markets would be exempt (combined annual monetary value is less than $500,000 and all sales to qualified end user).

It must be noted that such farms exempted under the new Produce Safety Ruling are NOT exempt under the adulteration provisions of the Federal Food, Drug and Cosmetic Act, which requires production of fruits and vegetables that are free of biological, chemical and physical contamination.

Produce Safety Alliance housed at Cornell University has provided additional information on exemptions of the ruling at Comments on proposed ruling can be expressed at!docketDetail;D=FDA-2011-N-0921. Specific questions about the proposed ruling can be emailed to