• As previously covered on this blog, the Food Safety Modernization Act (FSMA) established the Voluntary Qualified Importer Program (VQIP) for expediting the review and import entry of human and animal foods into the United States. Certification through FDA’s Accredited Third-Party Certification Program is one of the eligibility criteria for participation in the VQIP. Under the VQIP, certification bodies (1) conduct consultative and/or regulatory food safety audits and (2) issue certifications to eligible entities that produce food for humans and animals. Aside from certifications issued for participation in the VQIP, which is fee-based and completely voluntary, certification may be required by FDA as a condition of entry for imported food products in limited circumstances when specific, risk-based criteria are met.
  • Third-party “certification bodies,” otherwise known as third-party auditors, must be recognized by accreditation bodies before they can issue certifications under the Accredited Third-Party Certification Program. Accreditation bodies, in turn, must apply for and receive recognition from FDA before they may accredit certification bodies. FDA announced the recognition of International Accreditation Services, Inc. (IAS) of Brea, California as an accreditation body in an August 23, 2018 constituent update.
  • As can be seen on FDA’s Public Registry of Recognized Accreditation Bodies, IAS is only the fourth accreditation body recognized so far under the Accredited Third-Party Certification Program. IAS joins ANSI-ASQ National Accreditation Board (ANAB), the American National Standards Institute (ANSI), and the National Bureau of Agricultural Commodity and Food Standards (ACFS) which were recognized – with more limited scopes of authority – earlier this year. IAS is currently the only recognized accreditation body whose scope of authority includes FDA’s regulations on Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers (LACF) and Acidified Foods. IAS and some of the other three FDA-recognized accreditation bodies have the ability to recognize certification bodies for conducting food safety audits under FDA’s Current Good Manufacturing Practice, Hazard Analysis and Risk Based Preventive Controls for Human Food (Preventive Controls for Human Food rule), Current Good Manufacturing Practice, Hazard Analysis and Risk Based Preventive Controls for Animal Food (Preventive Controls for Animal Food rule), Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption (Produce Safety Rule), Hazard Analysis and Critical Control Point (HACCP) Systems (Juice HACCP), and Fish and Fishery Products (Seafood HACCP).