In November 2015, the U.S. Food and Drug Administration (FDA) published the Food Safety Modernization Act (FSMA) final rule for "Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption," commonly referred to as the "Produce Rule."
On December 11, the FDA participated in a webinar covering the final Produce Rule. The presentation highlighted key provisions of the rule, what businesses and commodities are covered or not covered, and how specific provisions may or may not apply to industry members' businesses.
The webinar was hosted by PMA and United Fresh, along with regional partners California Leafy Greens Marketing Agreement, Canadian Produce Marketing Association, Florida Fruit and Vegetable Association, Fresh Produce Association of the Americas, Georgia Fruit and Vegetable Growers Association, Northwest Horticultural Council, Texas International Produce Association, and Western Growers Association.
Useful links for more information include:
Dr. Samir Assar, director of the Produce Safety Division, FDA Center for Food Safety and Applied Nutrition
The final Produce Rule builds upon extensive stakeholder outreach and input, Dr. Assar explained. The rule establishes a regulatory framework that considers may factors associated with produce and the farming community, including the diversity of operations and a broad range of crops and practices both domestically and abroad. He also noted FDA applied an integrated approach to the rule, drawing on current scientific information, outbreak data and past experiences.
The final Produce Rule revises the farm definition to clarify that the relevant entity is the farm operation. It also focuses on identified routes of contamination, rather than taking a commodity-based approach, and applies Current Good Manufacturing Practice-like provisions, numerical criteria and monitoring provisions.
The rule covers produce for human consumption, both domestic and imported, Dr. Assar noted. The rule does not cover:
- Produce for personal or on-farm consumption
- Produce not a "raw agricultural commodity"
- Certain specified produce rarely consumed raw
- Farms with produce sales of ≤ $25,000 per year
Produce that will receive commercial processing (i.e., a "kill-step" or other process that adequately minimizes hazards) is eligible for exemption, with modified requirements, Dr. Assar explained. A qualified exemption with modified requirements also exists for farms that generate less than $500,000 annual food sales, and for farms where the majority of food sales, and for farms where the majority of food sales to "qualified end-users." Produce businesses must evaluate these exemptions and the final Produce Rule in greater detail to gain certainty on compliance requirements for their specific operation.