Memo to Food and Feed Ingredient Suppliers: Would Your Auditor Pass Muster with FDA?

By Diane B. McColl & Ricardo Carvajal –      

In an attempt to improve import safety and further implement its Food Protection Plan, FDA has issued a Guidance for Industry titled “Voluntary Third-Party Certification Programs for Foods and Feeds.”  The guidance recognizes that independent certification of a supplier’s compliance with food safety and security requirements has increasingly become a condition of doing business in the U.S. and elsewhere, and that ensuring the quality of certification programs could help FDA make more effective use of its resources and reduce the likelihood that businesses will be subject to multiple audits by different certification programs. 

The guidance is billed as a step toward “future recognition” of specific certification programs.   If and when FDA decides to recognize specific certification programs, then foods from an establishment certified by a recognized certification program would be looked upon favorably by FDA.  In FDA’s words, recognition would mean that “FDA has determined that certification may be a reliable reflection that the foods from an establishment certified by the certification body meet applicable FDA requirements,” among other criteria.

Although participation in a recognized certification program would be voluntary and would not affect the rights or obligations of an establishment, there are a number of potential carrots under consideration.  First, being certified could reduce the likelihood of inspection by FDA or expedite entry into the U.S.  Second, certified establishments could be acknowledged through inclusion in a public database.  Third, certified establishments might be excluded more quickly by FDA during outbreaks of foodborne illness.  Fourth, certification could aid removal of a product from an import alert.  Finally, although not explicitly mentioned in the guidance, we suspect that certification also could reduce the likelihood of inspection by state authorities.

Even if FDA does not go forward with recognition of specific certification programs, the criteria laid out in the guidance are likely to influence the operation and content of such programs.  In considerable detail, the guidance addresses a number of attributes of a “model” certification program, such as ensuring that the certification body has adequate authority, auditors are appropriately qualified and trained, audits are performed according to written policies and procedures, audits and auditors are monitored to provide quality assurance, appropriate steps are taken when there is noncompliance, and there is ongoing self-assessment of the certification program.