In November 2015 the Food and Drug Administration (FDA) published the final version of Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human
Consumption, otherwise known as the Produce Rule, in the Federal Register. Sixty days later, in January 2016, the rule became law. The Produce Rule is one of several new regulations mandated by the Food Safety Modernization Act (FSMA), which was signed into law in January 2011.
I have had many growers ask whether or not they are covered by this new rule. FDA has put out an excellent flow chart to help determine coverage. It can be found online at http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM472499.pdf. When determining coverage, there are some key questions that growers should ask:
- What is the value of my produce sales? Growers whose produce sales have averaged $25,000 or less for the past three years are not covered by this rule.
- What crops am I growing? FDA has listed several crops that are rarely consumed raw. Examples of these crops are winter squash and potatoes. These crops are exempt from coverage.
- What is the value of all my food sales? Growers whose total food sales (including agronomic crops and livestock) have averaged $500,000 or less over the past three years may receive a qualified exemption.
- How am I marketing my crops? In order to receive a qualified exemption, over one-half of food sales must be to a qualified end user, defined as the end consumer or a restaurant or retail food establishment located in the same state or the same Indian reservation that produced the food or not more than 275 miles from the farm that produced the food.
- Am I producing any crops for personal consumption? Crops grown for personal consumption (i.e. not for sale into the public food supply) are not covered by the Produce Rule
- Am I producing crops for processing? Crops grown for processing receive a qualified exemption, although certain conditions must be met to insure that crops are, in fact, being processed in a manner that adequately reduces pathogens.
Growers should remember that regardless of whether or not they are covered by the Produce Rule, there is never an exemption from liability. All growers who sell produce into the public food supply face the same liability, regardless of Produce Rule coverage, should the unthinkable happen and a foodborne illness outbreak is traced to their farm. As a result, all growers are reminded to use Good Agricultural Practices in the upcoming season as a means of reducing the risk of a foodborne pathogens contaminating produce on their farm.