Under this rule third-party auditors will be established as Certifying Bodies (CBs) to conduct food safety audits and issue certificates to foreign facilities and foods. The audits may be either regulatory or consultative.
Summary of How the Program Works
- The FDA recognizes an Accrediting Body (AB)
- The AB accredits qualified third-party CBs
- The CBs audit and issues certificates to the foreign facilities and foods
AB bodies may include foreign government agencies or private entities. An AB has the ability to suspend, withdraw or reduce the scope of accreditation of CBs. ABs must demonstrate their competency by meeting FDA and international standards ISO/IEC 17011 including having adequate number of qualified assessors and adequate resources to sustain operation.
Requirements for Third-Party Auditors
- Be competent, fair and objective
- Perform inspections unannounced
- Verify that the processor is meeting regulatory requirements that meets FDA food safety standards
- Notify the FDA on discovery of conditions that could cause or contribute to a serious risk to public health
- Provide audit report translations to the FDA in English within a reasonable time
Exemptions from the Program
- Alcoholic beverages
- Meat, poultry and eggs products under USDA oversight
The model of Accrediting Body/Certifying body relationship is the same as the relationship between the American National Standards Institute (ANSI) and HACCP Certification Bodies in the US. ANSI is an accrediting body. It accredits independent firms to offer HACCP audits and certification according to Global Food Safety Initiative (GFSI)-recognized certification programs such as SQF, BRC, FSSC 2000 and IFS.