Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
Effective Since: January 26, 2016
The FSMA Final Rule on Produce Safety is a landmark regulation by the U.S. Food and Drug Administration (FDA), establishing—for the first time—science-based minimum standards for the safe production of fruits and vegetables intended for human consumption. This rule is a core part of the FDA’s efforts under the Food Safety Modernization Act (FSMA) to shift the focus from responding to contamination to preventing it.
Who Must Comply and When
The rule applies to “covered farms” based on their average annual produce sales over the past three years, with compliance deadlines staggered according to business size.
General Produce (Excluding Sprouts)
- Large farms (>$500,000): Compliant since January 26, 2018
- Small businesses ($250,001–$500,000): Compliant since January 28, 2019
- Very small businesses ($25,001–$250,000): Compliant since January 27, 2020
Sprout-Specific Requirements (Subpart M)
Sprouts pose higher risks due to their moist, warm growth conditions.
- Large sprout farms: Compliant since January 26, 2017
- Small sprout farms: Compliant since January 26, 2018
- Very small sprout farms: Compliant since January 28, 2019
Agricultural Water – Non-Sprout Produce
Harvest and Post-Harvest Use:
- Large farms: Compliant since January 26, 2022
- Small businesses: January 26, 2023
- Very small businesses: January 26, 2024
Pre-Harvest Water Use:
- Large farms: Must comply by April 7, 2025
- Small businesses: April 6, 2026
- Very small businesses: April 5, 2027
(Visit the FDA’s dedicated webpage for enforcement discretion details and transition guidance.)
Key Requirements of the Produce Safety Rule
- Agricultural Water
Water used during growing, harvesting, and post-harvest handling must meet quality standards to minimize contamination. Rules vary by use type (pre-harvest vs. post-harvest) and include microbial testing, corrective actions, and records.
- Biological Soil Amendments
- Raw Manure: While FDA research continues, farms may follow USDA Organic Program guidelines—120 days between application and harvest for crops in contact with soil, 90 days if not.
- Stabilized Compost: Must meet microbial standards for pathogens like Salmonella, Listeria monocytogenes, and E. coli O157:H7. The rule outlines two validated composting methods to achieve compliance.
- Sprouts
Due to their history in foodborne outbreaks, sprout growers must meet strict additional requirements:
- Treat seeds to kill harmful pathogens.
- Test spent irrigation water or sprouts from every production batch.
- Conduct environmental monitoring for Listeria species.
- Take immediate corrective actions if pathogens are detected.
- Domesticated and Wild Animals
Farms must visually inspect fields and harvest areas for animal intrusion and contamination risks. If contamination is suspected, affected areas must be flagged and avoided during harvest. However, farmers are not required to exclude wildlife or alter natural habitats.
- Worker Health, Hygiene, and Training
All personnel handling produce or food contact surfaces must:
- Practice good hygiene (e.g., handwashing after restroom use)
- Avoid work if ill or infected
- Be properly trained in food safety principles
Supervisors must ensure that staff are qualified through training, education, or experience.
- Equipment, Tools, and Facilities
Farms must ensure that tools, equipment, and buildings (e.g., packing houses, greenhouses) are properly maintained, cleaned, and stored to avoid contamination. Toilets and handwashing stations must be accessible and sanitary.
Exemptions from the Rule
The rule does not apply to:
- Produce rarely consumed raw (e.g., potatoes, sweet corn, beets)
- Food grains (e.g., rice, wheat, oats, soybeans)
- Produce grown for personal/on-farm use
- Farms with ≤$25,000 in average annual produce sales over the past three years
Commercial Processing Exemption
Produce that will undergo commercial processing (e.g., pasteurization) that significantly reduces pathogens may be exempt under certain conditions.
Qualified Exemption
Farms may qualify for modified requirements if:
- Food sales average less than $500,000/year, and
- Over half of sales are to local end-users (consumers or local businesses within 275 miles or the same state/reservation)
Qualified farms must:
- Include their farm’s name and address at the point of sale or on the label
- Maintain documentation to verify exemption eligibility
FDA may revoke the exemption if:
- A foodborne illness outbreak is linked to the farm
- The farm’s practices pose a public health risk
Before doing so, FDA must notify the farm and allow a 15-day response window.
Variances
States, tribes, or foreign countries can request variances to specific rule provisions if they can demonstrate:
- Equal or better public health protection
- Scientific justification considering local conditions (e.g., climate, soil, crops)
Requests must come from competent authorities (e.g., food safety regulators) and do not require a systems recognition agreement with FDA.
Examples include variances for:
- Water quality standards
- Pathogen die-off periods
- Water testing frequencies
Compliance Dates for Modified Requirements
For farms under qualified exemptions:
- Labeling (if applicable): January 1, 2020
- Recordkeeping: As of the rule’s effective date
- Other modified provisions:
- Small businesses: Compliant since January 26, 2019
- Very small businesses: January 26, 2020
Environmental Impact
The FDA conducted an Environmental Impact Statement (EIS) to assess potential consequences of the rule. Key findings include:
- Anticipated reduction in foodborne illness
- Low risk of environmental disruption due to flexible provisions
- Potential cost-related challenges for Native American farmers due to lower average incomes
This rule reflects FDA’s commitment to improving food safety through prevention. As of 2025, most farms should already be in full compliance, including those under staggered water requirements. However, the agency continues to provide guidance, consider variances, and support implementation for farms of all sizes and types.
Source: United States Food and Drug Administration (FDA)
Reach out to Fresh Group Food Safety And Quality Consulting for any inquiries related to food quality and safety.