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How The FDA Rules Are Setting The Bar For Any Size Farm

Posted by Jeffrey Forbes on Oct 13, 2016 9:00:00 AM


As part of its modernization efforts under the Food Safety Modernization Act, the Food and Drug Administration released its final rule on Produce Safety in November of 2015.  The rule is one of seven issued under the FSMA, and was rolled out at the same time as two other rules - one on foreign supplier verification and one on third party accreditation.  The rule seeks to introduce science based standards for the growing of produce within the US to ensure its safety.

Goal: Same Rules Across All Farms

One of the major concerns in crafting the rule involved establishing rules that could be consistently and effectively implemented across a wide and diverse range of farms.  Farms across the United States can differ hugely in terms of size, environment, methods, and products grown.  The FDA wanted to establish a rule that could apply broadly across these ranges while still maintaining necessary flexibility. 

Read More: The FSMA Preventive Controls For Human Food

To do that, the agency chose to focus the rule on certain key areas to prevent contamination:


Water Standards

The Final Rule creates different standards for water quality based on the presence of E.Coli.  For water used in washing hands during and after harvest, water used in sprout irrigation, water used on food contact surfaces, and water used directly to contact produce during or after harvest, no detectable E. Coli is allowed.  For water applied to growing produce, the rule creates certain standards for the levels of E. Coli detected in the water which must not be exceeded.  The rule also creates testing and corrective measure requirements.

Biological Soil

The Final Rule requires that raw manure be applied to soil in a way that does not contact covered produce in order to minimize risk of contamination.  The FDA has also tentatively endorsed the USDA Organics rule requiring specific time frames between the application of raw manure to soil and the harvesting of produce.  Finally, the FDA Rule indicates an intent to continue to study the relationship between raw manure and food contamination to craft more specific detailed rules on this issue focused on food safety.


The Final Rule includes requirements for both domesticated and wild animals to ensure that these animals do not become sources of contamination.  Farms must monitor the area for potential sources of animal contamination prior to harvest and are encouraged to establish interval periods between harvest and grazing.

Worker Training and Health

As with many of the new rules under the FSMA, the rule requires farms to train workers on appropriate techniques to ensure compliance and reduce contamination.  The rule also requires that companies to take appropriate measures to ensure produce is not contaminated by sick employees and establish hygienic food handling practices.


The rule requires certain standards be implemented to ensure that building, tools, or equipment do not become sources of food contamination.  This includes ensuring that buildings have appropriate washroom facilities as well as establishing requirements for storage and maintenance.


Finally, for those farms growing sprouts, the rule imposes a host of more extensive and complicated requirements above and beyond normal produce.  This results from an acknowledgment by the FDA that many recent incidents of food contamination arise from sprout growing conditions because they require warm, moist, and nutrient rich environments.

Ultimately, the rule only applies to farms seeking to sell their produce as a raw agricultural product and does have room for several exemptions.  Those in the food industry however, should stay abreast of these changes in regulatory compliance and do their best to ensure that both they and their suppliers remain in compliance.

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Topics: Manufacturing Risks, For Your Business