A voluntary pilot programme has been announced by the Food & Drug Administration (FDA) which will assess the alignment of private third-party food safety and audit standards with the requirements in two regulations as set out by the FDA Food Safety Modernization Act (FSMA). These rules are Preventive Controls for Human Food (PC Human Food) and Produce Safety.

This launch comes as the FDA seeks reliable third-party audits which can help ensure food safety, including the use of audit data in risk-prioritisation for FDA regulatory activities.

Buyers and others in the food supply-chain often use third-party audits to assess the quality and safety of a product. For example, importers and receiving facilities might stipulate an audit as part of a purchase agreement. In addition, three FSMA regulations – the PC Human Food, Preventive Controls for Animal Food (PC Animal Food) rule, and Foreign Supplier Verification Programs (FSVP) rule –  allow for third-party audits to be used as supplier verification activities.

The hope is that this programme will help the agency and industry to understand how to best determine whether these standards align with FDA regulations and offer confidence that the standards used to audit suppliers adequately consider FDA’s food safety requirements.

In addition, alignment determinations could help the FDA’s investigators more efficiently determine whether importers and receiving facilities are in compliance with the FSMA supplier verification requirements.

As part of the one-year pilot, the FDA plans to selec and assess up to five third-party food safety standards for alignment with the requirements in the PC Human Food and/or Produce Safety rules. The pilot will gauge the resources required to review and assess third-party standards for alignment with these rules, the ability of the pilot participants to provide adequate information to enable FDA to make a determination of alignment, and whether FDA audit comparison templates, available at FDA.gov, are helpful in making alignment determinations.

Members of the public, including owners of third-party food safety standards, are being asked by the FDA to submit their requests to participate. This must be done within 30 days after publication in the Federal Register and include the following information: Company and contact name; contact phone number; and contact email address.

Although not required for consideration, the FDA is particularly interested in whether you are the owner of a third-party food safety standard, and the type of food safety standard you have developed.

Electronic submission of these requests can be sent to StandardsAlignmentPilot@fda.hhs.gov. Additional information about the pilot programme and how to apply can be found on the FDA website.