GMA FORUM: If third-party certification becomes reality, what will it take, in terms of internal organization, additional FDA staffers in the US and abroad (‘boots on the ground’), and time to train them, for the Agency to be able to properly evaluate the large number of audits that will be submitted to it?
At what point will FDA disallow importation of products from manufacturers who fail their first third-party audit? In general terms, what will be the appeals and/or recertification process? What will be the timeframe, so that, for example, a company is not put out of business for a minor infraction or procedural anomaly?
HHS SEC. MIKE LEAVITT: I’ve already touched on the broad points of this question in my previous answers, and its narrow specifics are mostly things that will have to be worked out over time. But the FDA does not necessarily have to train third-party certifiers. The FDA’s role is to determine how credible a given certification is and to support the whole system.
Third-party certification is a reality in today’s global market. That’s why we believe it is important to implement a program whereby the FDA would accredit independent third parties, or recognize entities that accredit such third parties, to evaluate compliance with FDA requirements. The increasing flow of goods among nations has revealed inadequacies in America’s traditional approach to import safety. The United States can no longer expect to ensure the safety of our imports by waiting until they arrive on American soil to conduct inspections. This approach
cannot handle the mass of goods arriving in this country each day. The United States is shifting its strategy to a risk-based approach aimed at ensuring import safety over the full lifecycle of the product.
The FDA simply does not have enough inspectors to check all imports coming from the hundreds of thousands of different suppliers around the world. The goal of third-party certification is to create an accreditation process that will effectively expand the FDA’s reach and its ability to enhance food safety.
GMA FORUM: As FDA itself notes, market forces ‘give companies a strong motivation to be vigilant and even innovative in ensuring food safety. The laws of regulation must encourage, not disrupt, these motivations. Rather than taking over responsibility from food companies, FDA wants to protect their flexibility to pursue it vigorously.’ In your view, what would be the advantages of a mandated approach to certification? The risks? What would be the advantages of a voluntary approach? The risks? ‘Arbitraging’ these, so to speak, what, in your view, would be the net benefits and risks? What, in your view, would be the best ways to manage these so that food safety and security are best and most quickly enhanced and consumer confidence restored to previously high levels?
HHS SEC. MIKE LEAVITT: Both approaches have their place, but voluntary actions among private actors are a crucial — and more efficient, effective, and flexible — part of ensuring food safety. My visit to Cochin, India produced an example of this.
I met with a group of business owners known as the Spice Board. My sense was they really get it. They can see the need to get ahead in product safety as a matter of brand protection and market enhancement. They have created
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