FSMA Produce Safety Rule: Complete Guide

What Is the Produce Safety Rule?

The Produce Safety Rule is one of the seven foundational rules of FSMA. It establishes the first-ever federal standards specifically for the on-farm production of fruits and vegetables. The rule targets the most common contamination routes for fresh produce — water, soil amendments, worker practices, animals, and equipment — and requires farms to implement preventive measures.

The rule was finalized in November 2015 and has been phased in based on farm size. As of 2024, all covered farms must be in compliance. FDA updated the agricultural water provisions in 2024 with a pre-harvest assessment-based approach.

Who Must Comply?

The rule applies to farms that grow, harvest, pack, or hold "covered produce" — fruits and vegetables that are consumed raw. Key exemptions include:

• Produce rarely consumed raw: Asparagus, beans (except sprouts), beets, cranberries, potatoes, sweet corn, and others listed in 21 CFR 112.2
• Produce for commercial processing: Produce that receives a kill step (like canning or pasteurization) is exempt if specific documentation requirements are met
• Small and very small farms: Farms with less than $25,000 in annual produce sales are exempt. Farms with $25,000-$500,000 in sales may qualify for a qualified exemption if they sell primarily to consumers or local retailers
• Produce grown for personal consumption: Not for commercial sale

Agricultural Water Standards

Agricultural water is one of the most significant contamination pathways for fresh produce. The FDA finalized updated agricultural water requirements in 2024 that replace the original numerical testing standards with a pre-harvest assessment-based approach:

• Pre-harvest water assessments: Farms must conduct systems-based assessments of their agricultural water sources to identify and address potential contamination risks
• Harvest and post-harvest water: Water that directly contacts covered produce during or after harvest must have no detectable generic E. coli per 100 mL
• Water system inspections: Annual inspection of water distribution systems for potential contamination sources
• Corrective measures: When assessments identify risks, farms must implement corrective measures or mitigation actions

Biological Soil Amendments

The rule regulates the use of biological soil amendments of animal origin (BSAAO), such as manure and compost:

• Treated BSAAO (compost): Must meet specific treatment standards (e.g., composting at specific temperatures for required time periods)
• Untreated BSAAO (raw manure): The rule does not currently establish a specific application interval for untreated BSAAO, but farms must not use it in a way that contacts covered produce during or after growing
• Documentation: Records of treatment processes, application dates, and sources must be maintained

Worker Training and Health

Farms must establish training programs and health/hygiene requirements for all personnel who handle covered produce:

• Training topics: Principles of food safety and hygiene, FDA food safety regulations, standards established by the farm, proper handwashing, and illness/injury reporting
• Training frequency: At hiring, with periodic refresher training at least annually
• Health and hygiene: Workers must wash hands thoroughly before handling produce, after using restrooms, and after any activity that may contaminate hands
• Illness policy: Persons with symptoms of illness that could contaminate produce (diarrhea, vomiting, jaundice, open lesions) must be excluded from produce handling
• Visitor policies: Visitors to growing and packing areas must be informed of relevant food safety practices

Equipment, Tools, and Buildings

Equipment and buildings used for covered produce activities must be maintained to prevent contamination:

• Food contact surfaces must be adequate for intended use, cleanable, and maintained in sanitary condition
• Equipment and tools must be cleaned and sanitized as needed based on use and risk
• Buildings used for packing must protect produce from contamination (e.g., pest control, proper drainage, adequate lighting)
• Toilet and handwashing facilities must be accessible, properly supplied, and maintained

Domesticated and Wild Animals

The rule requires farms to take measures to prevent contamination from animals:

• Monitoring: Farms must monitor growing areas for evidence of animal intrusion or activity
• Assessment: When animal activity is detected, assess whether produce may have been contaminated
• Corrective actions: Do not harvest produce that is visibly contaminated by animal activity
• Grazing: Land used for grazing must have adequate time between grazing and produce production

Growing, Harvesting, Packing, and Holding

Additional requirements apply to specific activities:

• Growing: Take steps to prevent contamination of covered produce during growing, including managing soil amendments, water, and animals
• Harvesting: Ensure harvesting equipment is clean and in good condition; inspect containers for contamination
• Packing: Packing activities must be conducted in a manner that prevents contamination; food contact surfaces must be sanitized
• Holding: Produce must be held under conditions that protect it from contamination and deterioration

Record-Keeping Requirements

Covered farms must maintain records including:

• Agricultural water assessment and testing records
• Biological soil amendment treatment and application records
• Worker training records
• Equipment cleaning and sanitation records
• Corrective action documentation

Records must be retained for at least two years and must be available to FDA upon request during inspections.

How Assurentry Can Help

Assurentry supports farms and produce operations with FSMA compliance:

• FDA facility registration: Registration and renewal for farms that pack or hold produce
• Produce Safety Plan development: Customized compliance plans for your farm operations
• Traceability compliance: Integrating Produce Safety requirements with FSMA 204 traceability
• FSVP for imported produce: For importers of fresh produce from foreign farms