Under such a comparability agreement, “nations can concentrate more resources, including inspections, on foods that present a greater risk, providing for improved food safety overall,” wrote Deborah M. Autor, deputy FDA commissioner for global regulatory operations and policy, and Michael R. Taylor, deputy FDA commissioner for foods and veterinary medicine in a Dec. 13, 2012 blog posting. While comparability certification is not required for countries to export food into the U.S., “any country that believes it can meet the very high bar will have the option of seeking recognition.”
“Hundreds of customs brokers have served notice that they will no longer act as U.S. agents for any foreign food facility.”
—•Mark FeDuke, director of trade compliance, VLM Foods
An FDA systems recognition pilot project is currently underway in Canada. “Canada and the United States are working in parallel towards strong food safety systems. Enhancements over the next couple of years will mean a stronger food safety culture, safer food supply, better trade opportunities, and better regulatory cooperation,” says Prince.
According to Katherine Bond, director of FDA’s Office of Strategy, Partnerships, and Analytics, the agency has many approaches to facilitate increased collaboration. “Local, state, federal, and international regulators should ultimately form one network protecting our respective consumers to build one global product safety net. FDA is committed to working with specific countries to identify which approaches make the most sense,” she told the Food Safety Summit.
Partnering with food agencies in other countries is one of four “pillars” the FDA has established to improve product safety. The others are:
- Building global information systems and networks and proactively share data with peers,
- Expanding intelligence gathering with an emphasis on risk analytics, and
- Allocating agency resources based on risk leveraging the combined efforts of government, industry, and public and private third parties.
FSMA includes several provisions intended to improve imported food safety, including the Foreign Supplier Verification Program, third-party auditor accreditation, and the voluntary qualified importer program, among others. The White House OMB is still reviewing these regulations and some of them are expected to be released this year for public comment. Under the expected rules, imported foods will be held to the same safety standards as domestic foods, and importers and foreign suppliers must have controls in place to ensure product safety. Over the next several years, assuming adequate funding, the FDA will spend nearly $1.4 billion to hire hundreds of new staff and pay third-party private contractors to inspect foreign food suppliers, especially for high-risk foods.
Under the law, the FDA must establish offices in foreign countries and enter into agreements with foreign countries to facilitate inspections of their facilities. This expanded inspection and verification regime has the potential to trigger reciprocal requirements from other countries. As Mexico’s Fragoso puts it, “We need to recognize Mexico [will be] having third parties in the U.S. and the U.S. having third parties in Mexico.” In South Korea, lawmakers have introduced legislation that would allow Korean authorities to inspect food manufacturing facilities in foreign countries and require all food importers to supply the addresses of foreign manufacturing facilities before filing an import declaration.
“While FSMA will surely lead to improved food safety outcomes, one has to consider the potential for unintended consequences such as the impact on America’s export food supply chain when our trading partners create their own FSMA-like administrative requirements,” says Mark FeDuke, director of trade compliance at VLM Foods Inc., an international supplier of processed foods. FSMA will require U.S. importers to certify that foreign products meet all domestic food safety standards. In many cases, this means a U.S. agent or representative of a foreign company may be held liable for FDA reinspection fees and product recall-related fees and fines, he says.
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