Reporting from Proposed FSMA-related Audits Raises Concerns

Reporting requirements from third-party audits drew many questions from stakeholders at the agency’s public meeting on proposed rules on Foreign Supplier Verification Programs (FSVP) and the Accreditation of Third-Party Auditors/Certification Bodies, held in Washington D.C., September 19-20.

As you may know, the objective of the accreditation proposal is to strengthen foreign food safety audits – although the agency has indicated that it would consider a similar approach for third-party audits conducted in the United States.

The accreditation rule calls for reports to be submitted to FDA on conditions found in an audited facility that might lead to a serious risk to health. Participants in the public meeting sought assurances from the FDA officials — including Deputy Commissioner for Foods and Veterinary Medicine, Mike Taylor –that this would only be a requirement for a regulatory audit, and not for a purely consultative audit conducted for the purposes of assessing compliance ahead of time. If FDA requires reports from consultative audits, it could cause companies to avoid this type of audit entirely, with the unintended consequence of reducing the number of audits conducted, stakeholders warned. Or, if FDA-accredited auditors had to report findings from consultative as well as regulatory audits, it would encourage companies to seek consultative audits from non-accredited firms. So there are many possibilities for unintended consequences.

Taylor assured participants at the public meeting that the agency wants to be very clear about reporting requirements and when they will and won’t be required. It doesn’t, for example, want to drive companies away from using FDA-accredited auditors in order to protect themselves from reporting requirements, he said.

Consumer groups are concerned that the agency may extend the third-party accreditation program beyond its intended application to imported food and they point out that this was specifically excluded during the deliberations by lawmakers leading to the enactment of FSMA. They view regulatory audits as the domain of the regulatory authorities and not the business of private auditing firms. This policy issue has been debated for many years – and not just with regard to FDA.

Interestingly, the requirement for inspections conducted by certified third-party auditors is limited to only two situations:

  • Imported food determined to pose a safety risk and requiring certification by FDA as a condition of granting admission into the U.S.
  • Issuing foreign facility certifications that will be used by importers to establish eligibility for the Voluntary Qualified Importer Program.

Importers who rely upon third party audits as part of their Foreign Supplier Verification Program are not required to use accredited third party auditors. However, FDA believes that there will be much broader adoption by the food industry of third-party audits performed by auditors certified by FDA-recognized accreditation bodies.

It seems to me that an effective policy must take account of what is possible in practical terms. By this measure, a preventive approach using third-party audits is the only viable option and it is preferable to the alternative, which is likely to be paralysis and no improvement in food safety measures for imported food.

 

Posted in 2013, 2013 October, FSMA Perspective.