Produce Safety: Covered Farms, Exemptions and Water Testing

The produce safety rule applies to farms, and it decides coverage with money rather than with acreage. Two averages and one customer analysis determine whether a farm is fully covered, partly covered, or outside the rule entirely. Getting that determination right is the first task, because everything else follows from it.

The two thresholds and how they are calculated

A farm with average annual produce sales at or below the lower monetary threshold, calculated on a rolling three-year average and adjusted for inflation, is not covered at all. Above that figure, the farm is covered unless an exemption applies.

The qualified exemption uses different arithmetic. It requires two things at once. Average annual food sales — all food, not only produce — below the higher threshold on the same three-year rolling basis. And more than half of that food, by dollar value, sold directly to qualified end-users. A qualified end-user is the consumer of the food, or a restaurant or retail food establishment located in the same state or the same Indian reservation as the farm, or not more than two hundred seventy-five miles away.

Both parts must hold. A farm below the sales threshold that sells mostly to a distributor is fully covered, and a farm selling entirely at a farmers market but above the sales threshold is fully covered as well. The averages must be recalculated annually and the supporting records kept.

Commodities and uses outside the rule

Some produce is outside the definition of covered produce regardless of the farm. The rule lists commodities rarely consumed raw — among them asparagus, beets, cranberries, sweet corn, eggplant, ginger, okra, potatoes, pumpkins, sugar beets and winter squash — and those are not covered produce.

Produce grown for personal or on-farm consumption is excluded. So is produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance, where the farm discloses that the food is not processed to reduce pathogens and obtains written assurance from the customer that the processing will occur. That written assurance is a document with required content, and the exclusion fails without it.

Food grains, including cereal grains and pulses, are excluded as a class. Sprouts, at the other extreme, are covered by their own subpart with substantially more demanding requirements than the rest of the rule.

Agricultural water, before and after harvest

The distinction between the two water uses is the most important in the rule. Water that touches harvested produce or food-contact surfaces is held to a numeric microbial standard. Pre-harvest water is governed by an assessment that considers the water system as a whole — its source and construction, the degree of protection from contamination, the application method, the interval between application and harvest, and the crop's characteristics — and requires mitigation where the assessment identifies a hazard. The assessment is redone annually and whenever a significant change occurs.

Soil amendments, animals and the rest of the requirements

Biological soil amendments of animal origin are handled by treatment status. Amendments treated by a validated process to defined microbial standards may be applied with a minimum interval between application and harvest where the amendment contacts covered produce. Untreated amendments, including raw manure, must be applied in a manner that does not contact covered produce during application and minimizes the potential for contact afterward; the agency has deferred setting a numeric minimum application interval for untreated amendments and has stated it does not intend to enforce one in the meantime.

Domesticated and wild animals are addressed through assessment rather than exclusion. A farm must assess the relevant areas for evidence of animal intrusion immediately before harvest and, where evidence is found, evaluate whether the produce can be harvested and take measures to prevent contamination. Fencing and clearing are not required.

The remaining subparts cover worker training and health and hygiene, equipment, tools and buildings, and growing, harvesting, packing and holding practices. Records must be kept as the rule specifies, retained for two years, and made available on request; they must be dated at creation and signed or initialed by the person who performed the activity.

Where the produce rule sits against other requirements

Coverage under this rule does not settle whether the same operation is also a food facility. An operation performing manufacturing or processing on produce it did not grow may fall outside the farm definition and into the preventive controls and food safety plan requirements, with registration and a written plan. Packing operations at the boundary should analyze the activities carefully rather than assuming the farm definition covers them.

Nothing in this rule affects grade or size regulation, which comes from the marketing order handler obligations, or organic status, which is governed by the organic certification requirements and has its own rules on manure and compost that are stricter in places than the food safety rule. Farms marketing directly to visitors should also weigh the liability structure in the agritourism statutes, which does not reach food safety claims. Where irrigation water quality is the issue, the source and its administration may raise questions under the conjunctive management of surface water and groundwater.