The U.S. Food and Drug Administration on Monday signed a “systems recognition” agreement with New Zealand – the agency’s first formal acknowledgement that a foreign country has a food safety system comparable to the U.S.
In an interview with Food Safety News, Deputy Commissioner for Foods Michael Taylor touted the agreement—which is the culmination of more than two years of work—as the first step in what will soon be a key part of the agency’s import safety system as it rolls out the Food Safety Modernization Act.
“FSMA is looking for higher levels of assurance, in a very comprehensive way, about the safety of food coming into [the US],” said Taylor. “Looking to the future, the more that we can formally recognize what’s happening in other countries and incorporate that into our targeting of resources…the more we can target our efforts, the more the private sector can target its efforts, the more we build on what we’re doing and avoid duplication of efforts.”
Avoiding duplication and stretching scare resources is key as the agency has failed to keep up with the flood of imported food.
According to FDA, food imports to the U.S. have increased by 300 percent over the last decade, now accounting for 15 percent of the food Americans consume each year. The products come from more than a quarter of a million food facilities in over 200 countries and territories and enter the U.S. through more than 300 ports.
Assuring all of this food is safe for consumers is an enormous task for an agency trying to rebuild a new, preventive food safety system both at home and abroad.
FDA currently has 48 staff posted in 10 countries. According to the agency’s most recent annual report to Congress, in 2011, it spent about $33 million to inspect 995 foreign food facilities out of the 254,088 that are registered. FDA said it physically examined around 2.3 percent, or 243,400 import lines out of 10,439,236.
In 2010, New Zealand accounted for about 2 percent of U.S. food imports (by value), including meat products, according to USDA.
The agency believes that establishing which countries are comparable to the U.S. when it comes to food safety will help stretch scarce resources as the agency implements FSMA.
Recognizing that a trading partner is essentially equivalent to the U.S., for example, would almost certainly mean that FDA inspections of food facilities in that country will be less frequent than they will be elsewhere. FDA officials say they will also be more likely to trust the follow-up work performed by local officials if there is a food safety problem.
“We’re not saying there will never be problems with New Zealand products,” said Camille Brewer, the Director of International Affairs at FDA’s Office of Foods and Veterinary Medicine. “We are saying that we’ll look to New Zealand to take a stronger and very active role in follow up.”
To determine that the two countries’ systems are comparable, FDA is using what it calls the International Comparability Assessment Tool (ICAT). The system, which includes an extensive in-country audit, looks at several elements, including regulatory foundation, inspection and enforcement capabilities, training, verification and audit programs, illness outbreak response capability, program and laboratory resources, industry and consumer outreach programs and international engagement.
“We’ve been developing the concept of systems recognition as a way to formalize our understanding that there are countries around the world who have very developed food safety systems and who are, generally speaking, aligned with us in terms of the movement toward a focus on prevention and using science to ensure the safety of food,” said Taylor.
The new scheme sounds a lot like establishing equivalency, which the U.S. Department of Agriculture has long required before foreign countries can send meat or poultry to the U.S.
“It’s analogous, but it is quite different,” said Taylor. “The FSIS system is based upon demonstrating, at a very detailed level, equivalence with very specific inspection mandates and requirements that FSIS administers for meat and poultry plants for this country and it focuses on meat and poultry, specific commodities. Our systems recognition is at a broader and more general level and doesn’t require the same degree of [detailed] verification that equivalence does.”
Taylor also noted that the agreement does not have legally binding consequences, like equivalency does, and that it will just be one part of the FDA’s import safety system.
“It’s a harbinger of what’s to come over the long term in terms of building partnerships, collaboration, and mutual reliance with other countries’ food safety systems,” he said.
Another key element is the Foreign Supplier Verification Program, which is one of the key rules that has been stuck under review at the White House Office of Management and Budget for a year.
When asked when the rules will be released from their lengthy review, Taylor said: “I hope soon. The process is active – we hope we’ll be able to get our proposals out very soon.”