FDA Needs Structural Change to Emphasize Prevention By Sonia Salas, AVP, Science On Sept. 26, 2022, the U.S. Food and Drug Administration (FDA) announced it is working on developing food safety prevention strategies. Specifically, they shared their first two strategies for 1) salmonellosis and listeriosis associated with imported enoki and wood ear mushrooms and 2) salmonellosis associated with bulb onions. (Additional details are on the FDA Food Safety Prevention Strategy webpage.)
For years, Western Growers has encouraged the agency to focus on and devote resources to promoting prevention instead of primarily advancing compliance-based activities such as inspections, product surveillance sampling and outbreak investigations. We agree with the agency that preventing foodborne illness in fresh produce requires active partnerships among industry, the FDA and various stakeholders, which are founded on collaboration and trust. This all sounds great on paper when, in reality, it is not happening. Implementing the Food Safety Modernization Act (FSMA) regulations has been cumbersome and slow; many believe this is primarily due to the agency’s fragmented organizational structure, which has detrimentally affected the FDA’s culture and sense of accountability. This is corroborated by an independent review of the national food control systems of Australia, Canada, New Zealand and the United States, which was released by the U.K. Food Standards Agency in December 2021. It revealed significant differences in how each country implements and enforces food safety regulations. The review found that the United States’ development and enforcement of food regulations are fragmented, with responsibilities being split among multiple entities leading to unequal regulatory oversight for different regions and foods. The FDA’s current emphasis and use of public resources to conduct inspections and sampling assignments promote a compliance-centric agenda that provides limited opportunities for the industry to learn from these activities. Even outbreak investigations have not shed light on insights for the industry to learn and adjust. So, what is needed? In keeping with the agency’s “ Blueprint for A New Era of Smarter Food Safety,” food safety prevention strategies would leverage technology and data science to identify, establish and implement the practices and measures that have consistently been shown to reduce foodborne illness outbreaks. For prevention strategies to work, ALL stakeholders must work together, and the agency must shift food safety focus away from compliance and toward prevention strategies. Continuing to operate in individual silos has not resulted in substantial progress.
As previously stated, the FDA’s current areas of focus (inspections, sampling assignments and outbreak investigations) are not preventive and have resulted in very few valuable insights or learnings for the produce industry. We know that relying on FDA inspections as a primary regulatory tool is not an effective barometer of food safety. We also know the produce industry is not learning how to prevent contamination from sampling assignments or outbreak investigations. Prevention is not a “one-and-done strategy” and requires education, outreach and technical support. We need to work smarter and not make it more difficult for domestic produce growers to offer safe and healthy food sustainably. One example of a collaborative effort related explicitly to a foundational pillar of the FDA’s Blueprint for a New Era for Smarter Food Safety would be using private-public data trusts similar to the aviation industry. The Federal Aviation Administration, in collaboration with the airline industry, employs a cooperative framework that incorporates investigation, data collection, risk analysis and information sharing to create prevention strategies and reduce failures. Western Growers urges the agency to make structural changes within the organization, shift focus to advance prevention strategies, and, more importantly, embrace data science, technology and innovation in advancing efforts. While cultural and structural changes may take time, we are asking the agency to consider the following three crucial immediate actions: 1. A robust, sustained prevention agenda for farms that includes increases in state support and authority 2. Realized commitment to the four core elements of the agency’s New Era of Smarter Food Safety 3. FDA investments in food safety programs focused on applied research, outreach, and education. If we continue under the present model of allowing the development and implementation of foodborne illness detection efforts to outpace the necessary development of prevention programs, we will fail the consumer by undermining the accessibility, affordability, and trust in these nutritionally essential foods. Effectively reducing failures (outbreaks) in the produce industry requires a mindset change from compliance-centric to sound prevention strategies.
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NOVEMBER | DECEMBER 2022
Western Grower & Shipper | www.wga.com
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