FDA's Produce Safety Rule Set for Importer Verification Beginning 2017
The Food and Drug Administration’s recently released produce safety regulations (here) that, alongside its preventive controls rules, form the final piece of the food safety system with which importers must verify their suppliers’ equivalence. Foreign and domestic farms will have to begin complying with the produce safety rule over a six-year period beginning on the final rule’s effective date of Jan. 26. FDA’s concurrently-issued regulations establishing Foreign Supplier Verification Program require that importers verify their produce suppliers’ compliance with the produce safety rule beginning six months after their suppliers must comply (see 1511160014). For importers of sprouts, that could come as early as June 2017. The final rules are set to be published in the Nov. 27 Federal Register.
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Covered Products and Exemptions
The final rule applies to domestic and foreign farms that grow, harvest, pack and hold fresh fruits and vegetables meant for human consumption. The following products, farms and activities are exempt from coverage or receive modified treatment:
- Specified produce commodities that are rarely consumed raw
- Produce used for personal or on-farm consumption, or that is not a raw agricultural commodity
- Produce that receives commercial processing that adequately reduces the presence of microorganisms
- Farms that have an average annual value of food sold during the previous three-year period of $25,000 or less
- A “qualified exemption” for farms that (1) have food sales averaging less than $500,000 per year during the last three years, and (2) sell the majority of their food to consumers, or to restaurants or retail food establishments either in the same state or less than 275 miles away. These farms would be subject to modified requirements.
Farm Requirements
FDA’s produce safety rule relies on an “integrated approach” to regulating fresh fruits and vegetables, drawing from elements of food Current Good Manufacturing Practices, shell egg regulations, and Hazard Analysis and Critical Control Point (HACCP) programs. Specific provisions of the regulations would include:
Worker training and health and hygiene. Farms must establish qualification and training requirements for all handlers of covered produce or food-contact surfaces, as well as their supervisors. Hygienic practices and measures must be implemented, and documentation is required of required training.
Agricultural water. All agricultural water, defined as “water that is intended to, or is likely to, contact the harvestable portion of covered produce or food-contact surfaces,” must be of “safe and of adequate sanitary quality for its intended use.” Requirements must be established for inspection, maintenance, and other actions related to the use of agricultural water relating to covered produce. The final rule also establishes specific requirements for agricultural water quality depending on purpose, sets requirements for treatment of unsanitary water, and includes a recordkeeping requirement.
Biological soil amendments. The new regulations establish requirements for use of biological soil amendments of animal origin, and prohibit use of human waste for growing covered produce except in compliance with Environmental Protection Agency requirements.
Domestic and wild animals. If “significant evidence” of contamination of produce by domesticated or wild animals is found, farms cannot harvest produce that is reasonably likely to be contaminated with a known or reasonably foreseeable hazard.”
Equipment, tools, and buildings. The final rule sets requirements for equipment and tools that contact covered produce, including transportation equipment, and requires recordkeeping related to the requirements.
Sprouts. Special requirements apply to sprouts, which have been the subject of more FDA recalls than any other fresh produce, according to the proposed rule.
Staggered Compliance Date Ranges from Two to Six Years
Compliance dates for FDA’s new produce safety regulations are staggered based the size of the farm and the type of produce, with small businesses selling less than $500,000 of produce per year over a three-year period, and very small businesses selling less than $250,000 of produce per year over a three-year period, each receiving longer periods to comply. The default compliance dates for the produce safety rule are by Jan. 26, 2018 for most farms, Jan. 26, 2019 for farms that are small businesses, and Jan. 26, 2020 for farms that are very small businesses. However, different compliance dates may apply under the following circumstances:
Sprouts. For covered activities involving sprouts, compliance with the produce safety rule is required earlier, by Jan. 26, 2017 for most farms, Jan. 26, 2018 for farms that are small businesses, and Jan. 26, 2019 for farms that are very small businesses.
Agricultural water. Later compliance dates apply for agricultural water requirements in FDA’s final rule, with compliance required by Jan. 26, 2020 for most farms, Jan. 26, 2021 for farms that are small businesses, and Jan. 26, 2022 for farms that are very small businesses.
Qualified exemptions. For farms receiving qualified exemptions because of a low value of food sales to qualified suppliers, records supporting eligibility for the exemption must be kept beginning Jan. 26, 2016. Compliance with special labeling requirements for farms receiving qualified exemptions take effect Jan. 1, 2020. Compliance with all other requirements for farms receiving qualified exemptions is required by Jan. 26, 2019 for farms that are small businesses, and Jan. 26, 2020 for farms that are very small businesses.