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As a high school teacher in Chicago, in a past career, I was on a school bus headed south to the university campus of Champaign-Urbana, riding through the flat cornfields of Illinois. One of my students pointed out the window and asked, “Dr. Knutson, what are those… factories over there?” My reply was, “that is a farm.” In light of the new FDA guidance, the question is valid. Do on-farm processing steps change a location from a traditional farm to a factory? My previous blog post started with the definitions of supplier, receiving facility, and farm mixed-type facility. Farms are not required to implement a food safety plan, and farm mixed-type facilities have been under enforcement discretion while FDA figures this out. FDA took a giant step in sharing their current thinking on the definitions of produce covered by the Produce Safety rule and the Preventive Controls for Human Food rule. FDA recognizes the variety of produce grown on farms and approaches to building in food safety.

Produce Safety Rule Exemptions:

Farms with an annual average revenue under $25,000 are exempt. This makes sense from a public health view. Small farms are not going to cause wide-scale harm, in general. There are other exemptions for farms with an annual average revenue above $25,000 and based on how much is sold directly to customers through a farm stand-like store, local grocery store or restaurant. Another exemption is based on the sale of other products like hay or wine. For farms that don’t know where they fall, my advice is to ask an accountant and attorney to interpret the farm’s sales of commodities regarding the rule. See COVERED FARMS.

Produce is the edible portion of fruits and vegetables for human consumption. Produce grown for animal feed or other uses is exempt from the Produce Safety rule.

Grains are exempt from the Produce Safety rule because grains are always going to be further processed. Produce that is rarely consumed raw (RCR) is exempt from the Produce Safety rule. Examples include potatoes and beans.

Don’t worry about your backyard garden. Produce that is grown for personal use or on-farm consumption is exempt from the Produce Safety rule.

Farm Mixed-type Facilities:

The bottom line is that as soon as produce is processed in any way to make it a new food, the activity is under the Preventive Controls for Human Food rule. Most of us understand that roasting of nuts is a processing step that requires preventive controls to create a safe product. The same is true for making bags of chopped lettuce and sliced apples. These raw agricultural commodities (RAC) have been changed into processed food, and processed food is under the Preventive Controls for Human Food rule.

Until now, FDA has been hands-off on processing of RAC on the farm. If processing is done on a farm in a farm mixed-type facility, the process is under the Preventive Controls for Human Food rule. The facility must have a written hazard analysis, implement a food safety plan, and have a Preventive Controls Qualified Individual (PCQI). The FDA is seeking comments on their published guidance for farm mixed-type facilities. In some ways, the FDA guidance seems like too much. Do we really need this for farms? Then I am reminded of Salmonella outbreaks from cantaloupe. In one outbreak the melons were only washed as a processing step, but in such a way as to not remove or kill pathogens. The outbreak covered 28 states with 143 hospitalizations of 147 documented cases. There were 33 deaths. Yes, we need this.

    “If you’re a farmer or anyone processing food whose company is interested in using ConnectFood to write or compile your food safety plan, check out our Enterprise tier. This Enterprise-level subscription allows you to experience full systems management, including having multi-facility supplier management, multi-facility records management, and direct access to food safety experts.” – Matthew Botos, CEO.

The ConnectFood website has free resources, and the folks at ConnectFood are here to help! Contact us.

About the Author
Kathy Knutson, Ph.D.
Kathy Knutson Food Safety Consulting LLC
Dr. Kathy Knutson works nationwide with food manufacturers on recall investigations, problem-solving, training, and Food and Drug Administration (FDA) compliance. After being trained in 2016 as a Lead Instructor with the FDA-recognized curriculum for Preventive Controls Qualified Individuals, she has delivered over 20 workshops to the food industry. With 35+ years in microbiology and 15 years of full-time teaching, Dr. Knutson is passionate about training and is an active communicator at all levels of an organization. She has taught and consulted with companies on laboratory methods, interpretation of lab results, quality assurance, sanitation, environmental monitoring, Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs), Hazard Analysis and Critical Control Points (HACCP) and the FDA’s Food Safety Modernization Act (FSMA). As a life-long learner, Dr. Knutson is trained in the prevention of intentional adulteration, a topic on the horizon for the food industry. Dr. Knutson is a contributing author at CannabisIndustryJournal.com. Dr. Knutson writes a food safety blog and contributes expert services to manufacturers through ConnectFood.com, an online site for writing HACCP and food safety plans. When Dr. Knutson is not traveling, she works from home in Green Bay, Wisconsin, where she lives with her husband, two sons, and an adorable Bernedoodle. Learn more about her at https://www.linkedin.com/in/kathyknutsonphd.