In the processed food world, regulatory inspections and third-party audits are commonplace, and the lines between the two are fairly well established. In the fresh produce industry, the lines between audits and inspections are not quite as clear when it comes to the growing environment. Still, audits and inspections are not interchangeable.
Some of the confusion stems from the fact that government officials have audited farms for many years. Examples include USDA’s Agricultural Marketing Service (AMS), which provides Good Agricultural Practices (GAP) audits including the Harmonized Audit, to improve market access for growers. Certain industries, such as leafy greens, have worked with states like California and Arizona to establish marketing agreements that specify food safety practices which are verified by state auditors.
Until the passage of the Food Safety Modernization Act (FSMA) and implementation of its Produce Safety Rule, FDA inspectors only showed up on farms to investigate outbreaks or other issues, not to conduct routine inspections. With this new authority, FDA will be working closely with the states, generally the departments of agriculture, to conduct inspections to the Produce Safety Rule. However, the frequency will be risk based and, in many cases, may be once every few years. To further complicate things, farms that want a third party to assess their preparedness for the Produce Safety Rule can request an “On-Farm Readiness Review,” which can be conducted by specially trained individuals from the states or from cooperative extension services.
We are seeing confusion in the marketplace when buyers demand annual proof of “FSMA compliance.” First, FSMA is an act written by Congress. FDA has issued several implementing regulations that affect different parts of the supply chain. Assuming that what buyers are really looking for is implementation of the Produce Safety Rule, how is this best communicated? Is this an audit or an inspection? Do the requirements of current GAP audits align with the requirements in the Produce Safety Rule? What about growers who are exempt from the Produce Safety Rule? Can they request to be inspected by regulators? If the harmonized audit is aligned with the rule, and is conducted by USDA, isn’t that the same as an inspection?
FDA unintentionally exacerbated these issues in the Preventive Controls supply chain program and Foreign Supplier Verification Program. The rules require that the default mechanism a receiving facility/importer should use to verify that a farm is compliant with the Produce Safety Rule is an annual onsite audit. Some may now perceive that regulatory compliance is being assessed through an audit. Throw in that the audit (or “assessment”) is conducted by the government — state or federal — and there is even more confusion.
Audits, whether conducted by USDA AMS, state employees, or private audit agents, are market driven. They are not the same as inspections. Many audit schemes have a requirement that the audited grower be in compliance with local, state, and federal regulations, and some audits have gone so far as to align with the Produce Safety Rule. At the end of the audit the grower receives a report that may or may not provide a score or other indication of how the grower fared against the specific audit criteria.
Inspections can only be conducted by FDA or states working in concert with FDA. Growers (or facilities under the Preventive Controls Rule) will never receive a certificate that says, “You passed the inspection.” But through the issuance of 483s or warning letters, inspectors can certainly identify deficiencies.
During this time of flux, when industry and government alike are trying to figure out the rules, it’s important that customers and buyers remain well informed and understand what they are asking of their suppliers.
Customer requirements typically exceed regulations, but the line between a market access audit and regulatory requirement must not get confused.
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