New FDA Preventive Controls Rules Expand Definition of a Farm

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The U.S. FDA's recently published final Preventive Controls rules expand the definition of a farm to include two kinds of farm operations. Registrar Corp explains the new definition.

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Farms do not have to comply with FDA's Preventive Controls rules

On September 15, 2015, the U.S. Food and Drug Administration (FDA) hosted a webinar regarding the agency's new definition of a farm, which was expanded under FDA's recently released final rules for Preventive Controls for Human and Animal Food. According to FDA, the new farm definition better aligns with modern farming practices.

The Preventive Controls rules expand the farm definition to cover two kinds of farm operations:

Primary Production Farm

An operation under one management in one general, but not necessarily contiguous, location devoted to the growing of crops, the harvesting of crops, the raising of animals (including seafood), or any combination of these activities. This kind of farm can pack or hold raw agricultural commodities (including those grown on a farm under a different ownership) and may conduct certain manufacturing/processing activities, such as dehydrating grapes to produce raisins and packaging and labeling raisins.

The definition of a Primary Production Farm was expanded to include operations that solely grow or harvest crops.

Secondary Activities Farm

An operation not located on the Primary Production Farm that is devoted to harvesting, packing and/or holding raw agricultural commodities. The Secondary Activities Farm must be majority owned by the Primary Production Farm that supplies the majority of the raw agricultural commodities harvested, packed, or held by the Secondary Activities Farm.

Both Primary Production and Secondary Activities Farms can manufacture, process, pack, or hold processed food as long as all such foods are consumed on that farm or another farm under the same management. Aside from this, most manufacturing and processing activities do not fall under the farm definition. Some examples given by FDA of activities that do not fall under the definition include pitting dried plums, chopping herbs, and roasting peanuts and seeds. FDA is currently working on a guidance document to further explain activities that do and don’t fall within the farm definition.

The expanded definition of a farm is significant because farms do not have to comply with FDA's Preventive Controls rules, which require covered facilities to maintain a written Food Safety Plan, approve raw material and ingredient suppliers, and more.

Registrar Corp is a U.S. FDA consulting firm and stays up-to-date on FDA regulations. The firm can help companies determine whether or not they are required to comply with FDA's Preventive Controls rules. For those that must comply, Registrar Corp can assist with the requirements.

For questions about FDA's Preventive Controls rules or other upcoming rules under the Food Safety Modernization Act (FSMA), contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at

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David Lennarz

Liviana Callahan
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