BRCGS participated in the U.S. Food and Drug Administration’s (FDA) voluntary Third-Party Food Safety Standards Alignment Pilot Program, which aimed to evaluate the requirements of third-party standards, such as Food Safety Issue 9, against the requirements of FDA regulations. This pilot focussed on the Preventive Controls for Human Food regulation (Preventive Controls for Human Food Rule), one of the regulations issued to implement the FDA Food Safety Modernization Act (FSMA).

We are delighted to announce that BRCGS Global Standard Food Safety Issue 9 and its Interpretation Guideline have been evaluated as part of this programme and recognised by the FDA to be in alignment with the existing requirements of the Preventive Controls for Human Food Rule.

The pilot aimed to understand whether third-party standards align with FDA regulations, and are  consistent with the New Era of Smarter Food Safety Blueprint published in July 2020. Although specific requirements of the Preventive Controls for Human Food Rule and the requirements of a BRCGS food safety audit standard are not identical, in general, the relevant technical components of the Preventive Controls for Human Food Rule are addressed in BRCGS Global Standard Food Safety, Issue 9.

Whilst a BRCGS Food Safety audit is not a substitute for FDA or state regulatory inspections for compliance with FDA regulations, this recognition will provide confidence to BRCGS Food Safety certificated sites that they are meeting certain requirements of the Preventive Controls for Human Food Rule. The findings of the alignment programme could also lead to efficiencies for the industry and provide importers and receiving facilities with confidence that their suppliers meet FDA food safety requirements.  Furthermore, this information, along with results of a sites audits could help inform the FDA in determining risk prioritization and resource allocation.

Find out more about Food Safety Issue 9