Dan Flynn’s June 6 article in Food Safety News, “Third-party auditor certification: Not the only tool in the toolkit,” makes the case that the Food and Drug Administration should not overly rely on third-party audits to oversee the safety of imported foods under the Food Safety Modernization Act (FSMA). This is certainly true for imported foods, given that Congress included explicit language in FSMA authorizing FDA to utilize, in a limited capacity, third-party auditors. However, the same cannot be said for domestic producers. Not only has Congress not authorized FDA to establish a domestic accreditation system, Congress has explicitly prohibited FDA from “requiring covered entities to pay a third-party to verify compliance” via the Preventive Controls and Produce Safety rules. This exclusion of third-party verifiers for domestic operations was no accident. As the FSN article astutely points out, there are substantial food safety concerns with equating a third-party audit with an inspection. There are other concerns as well. Audits are costly and both time- and labor-consuming — particularly for smaller farming operations and food businesses. Indeed, it was in recognition of these concerns that Congress included clear language in FSMA prohibiting FDA from requiring domestic producers to pay for third-party audits. Despite the prohibition against third-party audits, FDA continues to emphasize that “reliable” audits are essential to its compliance strategy for produce farms. This mixed messaging, combined with pressures from buyers to obtain third-party food safety certifications because “FSMA requires it” — even though we know this is not required — has left farmers and small food businesses between a rock and a hard place. If FSMA implementation is going to result in de facto audit requirements for farms and small businesses, then there is a public responsibility to help them pay for it. Better still, however, would be an expansion of alternative means by which smaller operations could verify compliance. This is particularly needed at the farm level where many operations are facing both market and regulatory pressures to demonstrate compliance with food safety standards. For many, this is their first time dealing with complex, regulatory processes. Self- and second-party assessments can provide valuable information on a farmer’s comprehension of food safety risks and responsibilities. Accessible and widely available training and educational opportunities — tailored to the unique needs and attributes of farms and food enterprises of varying types and sizes — would build capacity among producers, promote a deeper understanding of risk management practices, and encourage compliance among newly regulated entities. In some cases, there also can be a role for some third-party certification systems. The U.S. Department of Agriculture’s GAP/GHP food safety certification program is a prime example of a farmer-friendly certification option, one that USDA has also expanded and modified, through its GroupGAP program, to meet the needs of food hubs, farmers’ cooperatives, and other multi-owner local food businesses. By expanding education and outreach, and using self- and second-party assessments in combination with farmer-focused, third-party systems, we can create a food safety system that builds both consumer trust and farmer buy-in. We must not allow the public, or farmers, to be short-changed by a food safety system that relies on questionable, expensive third-party audits — particularly when Congress has made it clear that the costs of these new regulations not disproportionately be carried by farmers, but rather that the costs be shared by the public that benefits from them.
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