After twenty years of working directly with California regulatory agencies, one thing is consistent: regulatory detail matters on the farm. Michael Wegner’s team at Wegner Consulting translates that detail into practical compliance plans for Northern California growers.

What Northern California farms should know about FSMA and the Produce Safety Rule

The Food and Drug Administration’s (FDA) Food Safety Modernization Act (FSMA) Produce Safety Rule (PSR) sets minimum standards for the growing, harvesting, packing, and holding of fruits and vegetables that are typically consumed raw. The California Department of Food and Agriculture (CDFA) operates a state-level Produce Safety Program and conducts inspections and outreach in coordination with FDA guidance. Northern California growers should understand both federal PSR requirements and how CDFA enforces those rules on the ground.

Key PSR areas that affect farms

• Agricultural water (preharvest and postharvest): microbial water quality standards and testing expectations.
• Worker health, hygiene, and training requirements.
• Biological soil amendments of animal origin (manure) and related application practices.
• Sprout production controls (if applicable).
• Recordkeeping and documentation to demonstrate compliance or eligibility for exemptions.

Agricultural water: what the rule requires and what to do now

The Produce Safety Rule includes specific microbial quality metrics for agricultural surface water used for preharvest activities. FDA uses a two-metric approach: a geometric mean (GM) and a statistical threshold value (STV). For surface water used for preharvest applications that contact the edible portion of produce, the PSR sets the target microbial metrics at a GM of 126 CFU/100 mL or less and an STV of 410 CFU/100 mL or less (colony-forming units per 100 milliliters for generic E. coli). Farms are typically required to establish an agricultural water monitoring program, take corrective actions if metrics are exceeded, and keep records of testing and remediation.

California growers should note that CDFA has publicized a schedule for inspection and enforcement of agricultural water provisions, effective April 7, 2025. That date is when CDFA’s inspections will encompass the PSR agricultural water requirements in enforcement interactions. Farms should be ready with documented water assessments, baseline test results, and written corrective action plans by that date.

Practical steps for agricultural water compliance

• Inventory water sources: categorize surface water, wells, municipal supplies, and recycled water.
• Run a baseline testing program for surface water to establish geometric mean and STV results; document methods, dates, and lab certifications.
• Develop corrective action plans when results exceed PSR metrics (e.g., treatment options, alternative sources, or harvest timing changes).
• Maintain records of water testing, treatment, and corrective actions for inspection; store them in an accessible, auditable format.
• Attend or arrange Produce Safety Alliance (PSA) or CDFA training to ensure staff understand sampling and documentation expectations.

Qualified exemptions: the $500,000 threshold and what it means

Under FSMA’s Produce Safety Rule, farms whose average annual produce sales are below the qualified exemption threshold may be exempt from certain PSR requirements. The rule defines a qualified exemption based on an average annual produce sales amount of less than $500,000 (adjusted for inflation) over the previous three-year period, and additional limits tied to the definition of a “qualified end-user.” A qualified end-user is generally a consumer, restaurant, or retail food establishment located in the same state or within 275 miles of the farm.

Important operational points for Northern California farms considering or claiming a qualified exemption:

• Record and document sales calculations for the previous three years; keep supporting invoices and financial records.
• Ensure the majority of sales meet the qualified end-user definition (local consumers, restaurants, or retail outlets within 275 miles), or the exemption may not apply.
• Recognize that claiming a qualified exemption does not eliminate all responsibilities—farms are typically required to maintain documentation of the exemption and be prepared to present it during CDFA or FDA inquiries.
• Exemptions can be limited or removed if the farm’s sales or customer mix change; monitor annual revenue and sales destinations to remain compliant.

CDFA inspections: what inspectors will look for

CDFA inspectors follow PSR requirements when evaluating produce safety on farms. During an inspection, inspectors will typically review:

• Documentation of sales and any claimed qualified exemptions.
• Agricultural water testing records and corrective action plans.
• Worker training records, handwashing facilities, and illness reporting policies.
• Handling and storage practices for biological soil amendments and compost records.
• Records retention—inspectors expect accessible records to support compliance claims.

Inspections are not solely punitive. CDFA and local Produce Safety Program staff use inspections for education and to identify high-risk gaps. Nevertheless, farms should be prepared with accurate, complete documentation and clear on-farm procedures.

Training, resources, and local support

California growers should leverage available training and technical assistance:

• Produce Safety Alliance (PSA) Grower Training courses—national curriculum used by FDA and state programs.
• CDFA Produce Safety Program resources and local outreach events for growers in California.
• University of California Cooperative Extension (UCCE) local offices for region-specific guidance and water-quality assistance.
• FDA guidance documents on the Produce Safety Rule and agricultural water guidance materials.

Engaging with these programs ahead of inspections reduces risk. Firms should schedule on-farm reviews, implement sampling protocols, and train staff on hygiene and recordkeeping well before enforcement dates.

Common compliance gaps observed in Northern California

• Incomplete water test records or improperly documented sampling plans.
• Failure to reconcile sales records with qualified exemption claims.
• Insufficient worker hygiene facilities or missing training documentation.
• No written corrective action plan when water test results exceed PSR metrics.
• Poorly organized records that are difficult for inspectors to review quickly.

Next steps for growers

Northern California farmers should take a short list of concrete steps now: verify whether the farm is covered by the PSR or eligible for a qualified exemption; inventory water sources and begin baseline testing if surface water is used; organize sales and customer records to substantiate any exemption claims; and complete Produce Safety Alliance or CDFA trainings for managers and workers. These actions are strongly recommended before CDFA’s agricultural water enforcement and inspection activities take effect on April 7, 2025.

How Wegner Consulting helps

Wegner Consulting provides hands-on compliance planning for Northern California farms, including FSMA Produce Safety Rule gap assessments, agricultural water testing protocols, written corrective action plans, qualified exemption analyses, and inspection readiness. Michael Wegner and his team have decades of experience working with FDA, CDFA, and local partners to convert regulatory requirements into farm-ready procedures.

Contact Wegner Consulting for a confidential consultation.