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Produce Safety Rule

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Key Rule Requirements

Phone (360) 902-1848
Email producesafety@agr.wa.gov

What is the FSMA Produce Safety Rule?

The FSMA 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.

Summary of Key Parts

Worker 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.

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 FSMA Proposed Rule on Agricultural Water for FDA's proposed revisions to Subpart E.

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.

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).

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.

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.
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