The Food Safety Modernization Act (FSMA) extended FDA’s authority to include produce all the way to the farm level, which put the agency in unfamiliar regulatory territory. To avoid burdening covered facilities with unreasonable compliance demands, the agency proceeded with due caution in developing a final rule on Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, published November 27, 2015.
That rule, which went into effect on January 26, 2016, applies to both domestic and imported produce and has phased implementation dates, beginning in as little as one year for certain sprout growers.
With the exception of sprouts, the implementation dates are two years after the effective date for covered businesses, three for small businesses and four for very small businesses. Again with the exception of sprout operations, the final rule allows an additional two years to comply with some water quality standards, and testing and recordkeeping provisions.
The produce rule includes requirements for agricultural water quality and testing, manure and compost, and the exclusion of animals from growing areas, as well as hygiene and training requirements for farm workers. It also includes standards related to equipment, tools and buildings, and special testing and other requirements for sprouts.
As a first step, produce facilities should determine if they are covered by the rule. In essence, the rule applies to raw agricultural commodities (RACs). But there are numerous exemptions and opportunities for seeking a variance from one or more requirements.
The rule exempts fruits and vegetables that will go through a pathogen-reducing process such as a microbial “kill step” – provided it is appropriately documented — and food that is rarely consumed raw. Items on the rarely consumed raw list include: asparagus; black beans, great Northern beans, kidney beans, lima beans, navy beans, and pinto beans; garden beets (roots and tops) and sugar beets; cashews; sour cherries; chickpeas; cocoa beans; coffee beans; collards; sweet corn; cranberries; dates; dill (seeds and weed); eggplants; figs; horseradish; hazelnuts; lentils; okra; peanuts; pecans; peppermint; potatoes; pumpkins; winter squash; sweet potatoes; and water chestnuts.
The new rule does not apply to food grains, including barley, dent-corn or flint-corn (also known as Indian corn), sorghum, oats, rice, rye, wheat, amaranth, quinoa, buckwheat, and oilseeds such as cotton seed, flax seed, rapeseed, soybean, and sunflower seed.
The rule contains modified requirements for certain types of facilities, for example a farm with food sales averaging less than $500,000 per year during the previous 3 years that sell mainly to “qualified end-users.” Qualified end-users can be consumers or restaurants or retail food establishments in the same State.
The agency faced significant challenges in crafting the water quality requirements, which involve two sets of criteria for monitoring microbial water quality, depending on the product involved. The rule prohibits the use of untreated surface water in various situations, including for sprout irrigation, handwashing during and after harvest, washing food-contact surfaces, or for directly contacting produce during or after harvest.
The rule includes a second set of numeric criteria for agricultural water applied directly to growing produce other than sprouts.
The agency anticipates developing an online tool for use by farms to input their water sampling data and calculate the statistical values.
Because this is a whole new regulatory area for the agency, working through the complex compliance issues – especially for the water quality and testing requirements – will be a significant challenge.