FSMA Produce Safety Rule — Growing and Harvesting Standards for Fresh Fruits and Vegetables

The FSMA Produce Safety Rule (21 CFR Part 112) is FDA's first-ever binding science-based standard for the on-farm production of fresh fruits and vegetables. Issued under the Food Safety Modernization Act of 2011, it establishes minimum requirements for agricultural water quality, worker health and hygiene, biological soil amendments (including raw manure), wild and domesticated animal intrusion, equipment and building sanitation, and handling during growing, harvesting, packing, and holding. The rule covers farms with more than $25,000 in average annual covered produce sales and is scaled by farm size — the largest operations had to comply starting in 2018; smallest farms on a rolling schedule. Sprouts receive the most rigorous requirements of any produce category because they have been implicated in dozens of multistate outbreak investigations.

Legal Authority

• 21 U.S.C. § 350h — FSMA § 105; directs FDA to establish science-based minimum standards for the safe production and harvesting of fruits and vegetables; mandates coverage of agricultural water, biological soil amendments, wild and domesticated animals, worker health and hygiene, equipment and buildings; the primary statutory basis for 21 CFR Part 112
• 21 U.S.C. § 321 — FDCA definitions; defines "food," "adulterated food," and "interstate commerce" that determine coverage and enforcement jurisdiction for the Produce Safety Rule
• 21 CFR Part 112 — FDA's implementing regulation; establishes specific microbial standards, testing frequencies, and compliance schedules for covered produce farms; organizes requirements by hazard category (water, soil amendments, worker hygiene, equipment, sprouts)

Key Mechanics

The Produce Safety Rule applies to farms with more than $25,000 in average annual covered produce sales — with small farms (under $250,000 in sales to non-qualified end-users) and very small farms (under $25,000) either partially or fully exempt. For covered farms, the rule establishes specific microbial standards: agricultural water used in direct contact with produce must meet a geometric mean of 126 CFU generic E. coli per 100 mL and a statistical threshold value (STV) of 410 CFU per 100 mL (based on EPA recreational water standards). Biological soil amendments of animal origin — including raw manure — are subject to application-interval requirements: untreated amendments must not be applied within 9 months of harvest for produce with soil contact. The sprout provisions require in-process and finished-product testing for Salmonella and E. coli O157:H7 with corrective action and recordkeeping requirements. Worker health and hygiene provisions require that employees with communicable illnesses be excluded from produce contact activities; that hand-washing facilities be accessible; and that training in food safety basics be provided and documented.

Current Rule (2026)

What This Rule Does

The Produce Safety Rule establishes the conditions under which fresh fruits and vegetables must be grown, harvested, packed, and held to minimize microbial contamination risks — primarily Salmonella, E. coli O157:H7, Listeria monocytogenes, and Hepatitis A. Before FSMA, the fresh produce sector operated under voluntary guidance; the rule converted those best practices into enforceable federal standards.

Coverage is broad but targeted. Raw agricultural commodities that are consumed raw and not subject to a "kill step" in processing are covered — leafy greens, tomatoes, berries, tree fruits, herbs, root vegetables, and cucumbers are major examples. Produce "rarely consumed raw" is explicitly excluded: asparagus, navy beans, kidney beans, lima beans, and a specific list of other crops are carved out because they are almost always cooked before eating, eliminating the microbial risk.

The rule applies to farms — meaning facilities in one general physical location where farming occurs. It also applies to farm mixed-type facilities that both grow produce and conduct some food processing. Facilities that are primarily processing plants (not farms) fall under different FDA rules (e.g., 21 CFR Part 117 for food facilities).

Farms with average annual covered produce sales of $25,000 or less in the previous three years are fully exempt. Farms eligible for the qualified exemption — less than $1,000,000 in total food sales AND more than half of sales made directly to consumers or to restaurants or retailers in the same state — face reduced requirements: they must provide disclosures (labeling or other means) of the farm's name and address, and FDA can withdraw the exemption if the farm is associated with a foodborne illness outbreak.

Key Provisions

• § 112.1 — Coverage: raw agricultural commodities that are produce (as defined in § 112.3) and consumed in raw form are covered; produce that is rarely consumed raw (an explicit exhaustive list in § 112.2) is excluded; produce destined for commercial processing providing adequate kill steps is also excluded
• § 112.4 — Farm size thresholds: farms with average annual covered produce sales > $25,000 are subject; sales are calculated as a 3-year rolling average; if sales rise above the threshold, compliance is required the following year
• § 112.5 — Qualified exemption: farms with < $1,000,000 total food sales AND where more than 50% of sales are direct-to-consumer (or to in-state restaurants/retailers) qualify for modified requirements; the exemption is annual and must be re-verified each year
• § 112.11 — General requirement: covered farms must take appropriate measures to minimize the risk of serious adverse health consequences or death from covered produce, including measures reasonably necessary to prevent the introduction of known or reasonably foreseeable hazards
• § 112.21–112.23 (Subpart C) — Personnel qualifications and training: all covered farm workers who handle covered produce or food contact surfaces must receive training in food hygiene and food safety relevant to their duties; a qualified individual must be identified who is trained in food safety and responsible for overseeing produce safety activities; training must be in a language workers understand
• § 112.31–112.33 (Subpart D) — Health and hygiene: workers with symptoms of illness (vomiting, jaundice, diarrhea, open wounds) must be excluded from contact with covered produce; handwashing with soap is required at specific intervals including after restroom use, after touching animals, before handling produce; tobacco use, eating, and drinking in areas where produce is handled or packed must be restricted
• § 112.41–112.50 (Subpart E) — Agricultural water: all agricultural water must be safe and of adequate sanitary quality for its intended use; for harvest, packing, and holding water (including sprout irrigation water), there must be no detectable generic E. coli; for pre-harvest irrigation water, farms must assess water sources for contamination risks and take corrective action if contamination is found; a 2024 amendment (89 FR 37514) replaced the original statistical testing-based approach with an inspection-and-assessment framework, giving farms more flexibility while maintaining safety outcomes
• § 112.56–112.60 (Subpart F) — Biological soil amendments: treated biological soil amendments (composted manure meeting specific time-temperature standards) may be applied at any time relative to harvest; untreated biological soil amendments (raw manure, uncomposted materials) may only be used if sufficient time elapses between application and harvest for the amendment to break down — FDA has not finalized a specific numeric interval but has indicated it is evaluating scientific evidence; in the interim, farms must apply any application interval that minimizes contamination risk
• § 112.81–112.86 (Subpart I) — Animals: farms must assess intrusion by domesticated animals and wildlife into growing areas; steps to minimize the potential for contamination must be taken (fencing, deterrents); farms may not use covered animal intrusion as a basis for blanket harvesting prohibition but must evaluate and use judgment about whether affected produce is likely contaminated
• § 112.111–112.116 (Subpart K) — Growing, harvesting, and packing activities: harvested produce that has dropped to the ground before harvest (dropped produce) may not be distributed as covered produce; produce must be packaged in materials that are adequate, cleanable, and do not transmit hazards; food contact surfaces must be maintained in adequate sanitary condition
• § 112.121–112.128 (Subpart L) — Equipment, tools, buildings: all equipment and tools in contact with covered produce must be of adequate design, construction, and workmanship to enable cleaning; buildings must be suitable in size, construction, and design to reduce contamination potential; toilet and handwashing facilities must be accessible to workers and maintained
• § 112.141–112.150 (Subpart M) — Sprouts: the most rigorous category; seed sanitation treatment is required; water used as sprout irrigation water must have no detectable E. coli; mandatory testing of spent sprout irrigation water and sprouts for Salmonella and E. coli O157:H7 after each growing cycle; environmental monitoring for Listeria is required; positive tests trigger investigation, corrective action, and product hold/destruction procedures; the sprout requirements reflect the category's disproportionate role in produce-related outbreak investigations

How It Affects You

If you farm fresh fruits and vegetables: The rule is enforced by FDA inspectors who visit farms as part of the agency's FSMA inspection program. FDA prioritizes larger farms, farms associated with outbreak investigations, and farms that grow higher-risk produce (leafy greens, sprouts, melons). An FDA inspection of a covered farm typically includes a review of records (water testing results, training logs, soil amendment application records), observation of operations, and potentially collection of environmental swab or product samples. Non-compliance findings can result in a Warning Letter, followed by injunctions or mandatory recall if FDA finds an imminent hazard. First-time inspection findings for farms with good faith compliance efforts typically result in compliance assistance rather than immediate enforcement.

The qualified exemption benefits small farms that sell primarily at farmers markets, farm stands, or to local restaurants. If you sell a majority of your produce direct-to-consumer and have under $1 million in total food sales, you are exempt from most Part 112 requirements but must be able to document your exemption eligibility annually. If FDA withdraws your exemption following a foodborne illness outbreak linked to your farm, you face the same compliance timeline as a fully covered farm.

If you grow sprouts: You face the most demanding requirements under Part 112. Microbial testing of spent irrigation water or finished sprout product is mandatory after every growing cycle — typically every 7 days or at harvest. A single positive test for Salmonella or E. coli O157:H7 requires immediate corrective action, investigation of the source, hold of the affected batch, and determination of whether the product is adulterated. FDA inspects sprout operations with higher frequency than other produce farms and has used outbreak-investigation authority to seek injunctions against repeat violators.

If you buy fresh produce from farms: The Produce Safety Rule is the legal basis for the food safety controls that underlie the fresh produce supply. Retailers and food service companies that operate food safety supplier qualification programs rely on Part 112 compliance (verified through third-party audits like LGMA, PrimusGFS, or SQF) as a baseline. A produce farm's compliance history is increasingly visible through FDA's inspection database; buyers can check whether a supplier has received Warning Letters or been subject to recall.

State Variations

• Several states have entered into cooperative agreements with FDA to conduct Part 112 inspections on behalf of FDA — California, Florida, New York, and others participate; a state inspection counts as an FDA inspection
• Some states (particularly California for leafy greens, cantaloupe) have commodity-specific marketing agreements with additional microbial testing and traceability requirements that exceed Part 112 minimums
• States with their own food safety programs may conduct additional inspections independent of federal requirements; state and federal enforcement can run concurrently

Statutory Authority

This rule implements:

• 21 U.S.C. § 350h — Produce safety: directs FDA to promulgate science-based minimum standards for safe production and harvesting of fruits and vegetables raw agricultural commodities; enacted as Section 105 of FSMA (Pub. L. 111–353, 2011)
• 21 U.S.C. § 321 — Federal Food, Drug, and Cosmetic Act definitions: provides FDA's foundational authority over food and the definition of "adulterated" food
• 42 U.S.C. § 243 — Public Health Service Act: FDA's general communicable disease prevention authority

Recent Rulemakings

• 80 FR 74547 (November 27, 2015) — Original final rule establishing 21 CFR Part 112; set compliance dates staggered by farm size (large farms: 2018; small farms: 2019; very small farms: 2020); the sprout requirements had an earlier compliance date
• 89 FR 37514 (May 6, 2024) — Major amendment to the agricultural water requirements (Subpart E); replaced the original approach requiring statistical analysis of testing results with an inspection- and assessment-based framework; FDA acknowledged the original water testing approach was technically complex and burdensome for farms with multiple water sources; the 2024 revision maintains the safety objective while giving farms more operational flexibility; compliance dates extended into 2025–2026

Pending Action

FDA has indicated it continues to evaluate the appropriate minimum application interval for untreated biological soil amendments (raw manure) — this has been one of the most contested aspects of Part 112 since publication. The agency has not finalized a numeric interval, leaving farms to apply their own science-based judgment. Organic farming advocates and conventional agriculture groups have taken opposing positions on whether the finalized interval should match the National Organic Program's 90/120-day interval or be set at a different threshold based on pathogen survival data.