Produce Safety Rule

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The Produce Safety Rule

Program Manager: Roger Beekman
Phone (360) 902-1848

What is the FDA Produce Safety Rule?

The Produce Safety Rule (PSR) establishes, for the first time, science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables for human consumption. Prior to its publication in 2015, the only food safety law that applied to produce farms was the regulation against the selling of “adulterated” food as defined under the U.S. Food and Drug Administration Act (21 U.S. Code §342). That law continues to exist today and helps to prevent against, as a general definition, the sale of impure, unsafe or unwholesome food.

The PSR requires farms to adopt safe handling practices that help to minimize the growth and spread of pathogens that cause foodborne illnesses and outbreaks. Common bacteria linked to produce include toxigenic Escherichia coli (E.coli), Salmonella and Listeria monocytogenes. Fresh produce is susceptible to contamination - because it does not receive a “kill step” like cooked or commercially processed foods and pathogens are hard to remove or wash from the surface of produce. That is why preventive measures are so critical.

The PSR is structured by subparts that are summarized briefly below:
1. Worker Training and Health and Hygiene:

Subpart C sets specific training requirements for employees and supervisors that vary based on their assigned responsibilities. Subpart D defines general hygiene practices that must be followed, including proper handwashing, managing contamination from visitors, dealing with injured or sick employees and visitors, and setting policies related to glove and jewelry use, eating and smoking in production areas, etc.


2. Agricultural Water: Subpart E sets specific microbial quality criteria requirements for production and post-harvest agricultural water based on analytical tests for the indicator microorganism, generic E.coli. Subpart E requires general maintenance and annual inspection of agricultural water sources. It also provides corrective actions for managing hazardous issues or water quality concerns.  See the WSDA Produce Safety Program News and Resources page for updates on Subpart E.
3. Biological Soil Amendments of Animal Origin (BSAAO): Subpart F is focused on regulating soil amendments with animal waste or byproducts - including, but not limited to, raw manure, fish emulsions, bone meal and table waste. FDA establishes standards for when to apply BSAAO based on treatment types and how they are applied. Certain aspects of this subpart are reserved for further research and review.
4. Domesticated and Wild Animals: Subpart I pertains to covered activities that take place in an outdoor area or a partially-enclosed building, and sets requirements for grazing animals, working animals and animal intrusion. This subpart makes clear that nothing in the regulation authorizes the “taking” of threatened or endangered species as defined by the Endangered Species Act (16 U.S.C. 1531-1544).
5. Equipment, Tools and Buildings: Subpart L covers equipment and tool cleaning, sanitizing and maintenance requirements. Requirements cover food contact surface and non-food contact surfaces such a tractors or forklifts. Building maintenance includes pest and domestic animal control, toilet and handwashing facility maintenance, disposal of trash and sewage, etc.
6. Sprouts: Subpart M outlines specific requirements for sprouts, including different compliance timelines and testing requirements, as they are considered an especially high-risk food. Growers should consult the Sprout Safety Alliance (SSA) [external link]for more guidance and training information.
FDA’s factsheet, “Key Requirements: Final Rule on Produce Safety,” [external link] and National Sustainable Agriculture Coalition’s report, “Understanding FDA’s FSMA Rule for Produce Farms,” are two additional summary resources that provide effective interpretations of the Produce Safety Rule.

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