On June 6, 2011, Keith Greenaway, Vice President ACLASS, gave a brief talk at the FDA Food Safety Modernization Act Public Meeting: Focus on Inspections and Compliance. His prepared remarks follow and you can view the accompanying slides.
The ANSI-ASQ National Accreditation Board is a non-profit, non-governmental organization that provides accreditation services to public- and private-sector organizations in the areas of management systems, laboratories, inspection, reference material producers, proficiency test providers, product certification, and personnel certification. We are jointly owned by the American National Standards Institute and the American Society for Quality.
We operate predominately in the realm of ISO international standards, which are developed, based on consensus, and then adopted globally, and subsequently adopted as American National Standards. Two organizations provide oversight and a recognition infrastructure for accreditation bodies operating inside this global infrastructure. The International Laboratory Accreditation Cooperation (ILAC) was established to oversee laboratory and inspection body accreditation and the International Accreditation Forum (IAF) was established to oversee management systems and product and personnel certification. Recognized accreditation bodies then accredit conformity assessment bodies (that is, inspection agencies, laboratories, certification bodies, and product certifiers) to specific international standards who then audit and/or test for competence.
This generic third-party conformity assessment [slide 4] model illustrates the conformity assessment activities that are offered competently and credibly by ILAC and IAF member bodies. We developed the model in conjunction with the National Institute of Justice and the National Institute of Standards and Technology to support a new private-public sector partnership for accredited third-party conformity assessment activities with oversight.
The FDA must embrace a model based on international consensus standards that has already proven to work across international borders and within multiple industries through the existing recognition infrastructure of ILAC and IAF. In today's political environment, uncertainty remains whether funding will even be available for the mandated inspectors under the Food Safety Modernization Act. Given this uncertainty, it is imperative that the FDA work together with the private sector under the existing international infrastructure and rely on accredited private sector conformity assessment bodies to work in coordination with appropriate government inspectors to help fulfill the mission of the FDA under the Food Safety Modernization Act. The food industry is already operating under a realm of uncertainty as they prepare for both private sector food safety certification programs and government inspections. This is unnecessary duplication, which increases costs to the consumer and wastes taxpayer money.
The infrastructure that's used globally and by many U.S. regulators will support the FDA's role in protecting our nation's food supply under the Food Safety Modernization Act, and it will do so without adding unnecessary duplication for private industry and without wasting taxpayer dollars.
To have a truly effective food safety system in the United States, we must have a level of oversight that works in partnership and supports the role of the FDA to provide confidence in the entire lifecycle of the product. The best way to achieve this type of system is through accredited third-party conformity assessment services with oversight, through which an independent party verifies and provides written assurance of conformance to internationally recognized standards.