USA – The Food and Drug Administration (FDA) has launched a voluntary pilot program to evaluate alignment of private third-party food safety audit standards with the food safety requirements.

Under the program, third party food safety standards will be evaluated on their alignment with two regulations: the FDA Food Safety Modernization Act (FSMA) – the Preventive Controls for Human Food (PC Human Food) and the Produce Safety rules.

In a statement, FDA said that the pilot program will help the industry better understand how to determine whether these standards align with FDA regulations, a goal that is consistent with the New Era of Smarter Food Safety Blueprint.

Use of third-party audits

Buyers and others in the food supply-chain often use third-party audits to assess the quality and safety of a product.

For example, buyers, such as 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.

Importance of third-party audit evaluation

Determining that third-party audit standards align with the FSMA regulations provides importers and receiving facilities with confidence that the standards used to audit their 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.

Specifications of the voluntary pilot program

As part of the pilot, the FDA plans to select 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 evaluate the resources required to review and assess third-party standards for alignment with the PC Human Food and Produce Safety rules.

It will also study the ability of the pilot participants to provide adequate information to enable FDA make a determination of alignment.


The pilot will be conducted over the course of one year. Interested owners of third-party food safety standards and members of the public are invited to submit to the FDA their requests for participation.

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