FDA makes templates available for third-party standards

By David Fairfield, Senior Vice President of Feed Services

The U.S. Food and Drug Administration (FDA) this week made available templates that food and feed facilities and importers may use to compare the standards established in third-party audits to FDA food safety requirements.

The templates are designed to facilitate comparisons between the safety standards used in third-party audits and the food safety requirements of the Food Safety Modernization Act (FSMA)-related rules for current good manufacturing practice and preventive controls for human food (PCHF), current good manufacturing practice and preventive controls for food for animals (PCAF), and produce safety. The templates present certain food safety requirements in a table format, which can be used to compare third-party food safety audit standards to these food safety requirements more easily.

Under the rules for PCHF, PCAF and Foreign Supplier Verification Programs (FSVP), receiving facilities and importers may need to conduct onsite audits to determine if their suppliers are producing food in compliance with FDA food safety standards. An annual onsite audit is required under the PCHF, PCAF and FSVP rules when a hazard will result in a serious adverse health consequences or death to humans or animals (SAHCODHA) and is controlled by the supplier, unless the receiving facility or importer has made a written determination that other verification activities and/or less-frequent onsite auditing of the supplier provide adequate verification.

While receiving facilities and importers are to consider all applicable food safety regulations when conducting an onsite audit, FDA is providing templates for the rules for PCHF, PCAF and produce safety because importers are required to verify that their suppliers are using processes and procedures that provide the same level of public health protection as those required under these three regulations.

FDA does not require that these templates be used. Receiving facilities, importers and other stakeholders may use other means to determine that audits used as verification activities meet the supply chain requirements of the PCHF, PCAF or FSVP regulations.

The templates of the audit standards are available online:

• Audit Standards Comparison to the FDA Preventive Controls for Human Food Rule
• Audit Standards Comparison to the FDA Preventive Controls for Food for Animals Rule
• Audit Standards Comparison to the FDA Produce Safety Rule