FDA Produce Safety Rule Would Cover Farms, Serve as HARPC's Counterpart for FSVP Purposes
The Food and Drug Administration’s proposed “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” would serve as the companion regulation to the simultaneously released Hazard Analysis and Risk-Based Preventative Controls (HARPC) proposed rule. While HARPC would cover foreign and domestic food facilities that must register with FDA, the produce safety rule would cover growing, harvesting, packing and holding raw fruits and vegetables on foreign and domestic farms, with some exceptions. As proposed, the two regulations would not apply to the same activities. Pursuant to the upcoming Foreign Supplier Verification Program, importers will have to verify their foreign suppliers’ compliance with either the produce safety rule or HARPC, depending on the product being imported.
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Comments on the produce safety rule are due May 16.
Proposed Covered Products and Exemptions
The proposed rule would apply to farms that grow, harvest, pack and hold fresh domestic and imported produce. “Mixed-type” facilities, or farms that also conduct activities that trigger facility registration requirements and would therefore be subject to HARPC requirements, would be covered under the produce safety rule for their farm activities, and HARPC for their other activities. The following products, farms and activities would be exempted from coverage:
- 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, as well as restaurants or retail food establishments either in the same state or less than 275 miles away. These farms would be subject to modified requirements.
Proposed Requirements
FDA’s produce safety rule would rely 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 would have to establish qualification and training requirements for all handlers of covered produce or food-contact surfaces, as well as their supervisors. Hygienic practices and measures would need to be implemented, and documentation would be required of required training.
Agricultural water. All agricultural water would be required to be of “safe and sanitary quality for its intended use.” Requirements would be established for inspection, maintenance, and follow-up actions related to the use of agricultural water relating to covered produce. The proposed rule would also establish specific requirements for agricultural water quality depending on purpose, require treatment of unsanitary water, and include a recordkeeping requirement.
Biological soil amendments. The proposal would 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. After animals graze or work in fields where covered produce is grown, farms would be required to wait for an “adequate” period if there is a chance the animals will contaminate covered produce. Areas where there is a reasonable probability of intrusion by wild animals that could contaminate covered produce would have to be monitored.
Equipment, tools, and buildings. The proposed rule would establish requirements for equipment and tools that contact covered produce, as well as instruments and controls, and require recordkeeping related to the requirements.
Sprouts. Special requirements would 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 Would Range from Two to Four Years
The produce safety rule would be effective 60 days after the final rule is published. Compliance would not be required immediately, however. Small businesses with average annual sales under $500,000 would have to comply within three years of the effective date. Very small businesses, or those with average annual sales under $250,000, would get four years to comply. All other farms would have two years after the final rule’s effective date to comply, with certain exceptions.
FDA to Conduct Outreach to Foreign Facilities
“Recognizing that foreign farms in some countries may have difficulty understanding the rule’s applicability to them,” FDA said it will identify areas for outreach and technical cooperation to assist foreign farms in their compliance efforts..
(See ITT’s Online Archives 13010429 for summary of FDA’s proposed HARPC rule.)