Western Growers Response to Reagan Udall Report: Roadmap to Produce Safety

The Reagan Udall Report:  Roadmap to Produce Safety states “The FDA’s implementation of FSMA’s regulatory framework and the national integrated produce safety that FSMA envisioned are incomplete.”

FSMA’s intention was to reimagine food safety oversight as a pro-active, science-driven system rather than a reactive one. To state that the FDA’s implementation of this intent is incomplete with respect to fresh produce is an unfortunately all too accurate statement.

Supporters of domestic growers, such as Western Growers, have long been concerned about the FDA’s overemphasis on inspections and sampling as primary methods of improving food safety. Given the agency’s resource constraints and the sheer number of growers, neither of these regulatory activities can—or will ever be—conducted at a reasonably preventive level.

Failure to adequately emphasize and fund education and outreach has left many domestic growers with too little directly applicable information to improve food safety. It seems the FDA’s emphasis has been to try to find what a grower may have done wrong with little direction on what a grower can do to improve.

We encourage regulators to seek a collaborative prevention-based partnership with domestic growers focused on improving food safety knowledge and its operational application.

• Within state cooperative programs, the FDA should prioritize funding for local and regional food safety technical assistance and research.
• FDA should partner with the fresh produce industry to develop and support standardized Food Safety Best Practices.
• FDA should leverage public/private data-sharing partnerships.

Moreover, investigations of food safety events, such as outbreaks of foodborne illnesses, need a swift investigative response and root cause analysis. Information regarding the investigation findings need to be shared with other growers in a timely and actionable manner, and the affected grower(s) provided reasonable support to resolve the issue that led to the event. Achieving this requires technical experts, research capacity and local support. If these steps aren’t taken, then food safety events are likely to be repeated, causing unnecessary additional foodborne illnesses.

Modern genomic techniques facilitate the FDA’s ability to trace a food safety event to a farm; this helps public health authorities limit and understand outbreaks. The association of a pathogenic whole genome sequence with a specific farm or section of a farm makes it difficult for a grower to recover economically (which does not happen when imported produce is associated with a foodborne illness because the agency cannot easily access the foreign farm).

There remain many scientific unknowns regarding how environmental pathogens move around a farm and its surrounding ecosystem, and growers often cannot resolve the environmental source of pathogen. Coupled with sparse technical food safety resources to assist growers to address food safety events at the field level, farms have been decommissioned or moved to other non-edible crops when a pathogen whole genome sequence is associated with a farm or farm lot.

To best support domestic production of fresh produce in the U.S., the FDA needs to focus its resources on sustained prevention of foodborne illness, particularly to help growers avoid repeated similar events, rather than on “gotchas” when there are reoccurrences of the same event.

Western Growers members look forward to building a productive prevention-focused collaboration with the FDA, and we believe our recently announced data-sharing agreement is a strong step forward in this direction. For the agency, commissioning the Reagan-Udall Report certainly demonstrates their openness to engage with growers and other stakeholders to build more efficient ways of working. Consumers deserve a better food safety system—one that delivers accessible, proactive and science-based solutions that support fresh produce growers.