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FDA: We’ll publish FSMA foreign supplier verification rules ‘soon’

By Elaine Watson , 17-Jan-2012
Last updated on 17-Jan-2012 at 19:36 GMT

FDA: We’ll publish FSMA foreign supplier verification rules ‘soon’

The Food and Drug Administration (FDA) has missed its January 4 deadline for publishing details of how it will regulate imported food under the Food Safety Modernization Act (FSMA), but says it will update the industry “soon”.

Asked when it would publish rulemaking on its proposed Foreign Supplier Verification Program, come up with a definition of ‘high-risk foods’ and outline the associated certification scheme, a spokesman told FoodNavigator-USA: “The specifics of these programs are being developed now.

“Congress set a deadline for the regulations for the Foreign Supplier Verification Program at one year after the law was signed [January 4, 2011] - so we hope to release the proposed regulation soon, though I cannot speculate on when.

“The high risk foods have not been defined yet. The process for certification of foods is yet to be defined as well.”

He added: “Congress set a deadline for the 3rd party audit program for imports at two years after signing - so that would be next January. The voluntary qualified importer program (VQIP) would follow after that.”

Devil is in the detail

Quite how the foreign supplier verification scheme will work in practice was a source of much consternation in the trade, said Benjamin England, founder of legal practice Benjamin L. England & Associates and consultancy FDAImports.com.

According to the FDA, the scheme will “require importers to verify that their suppliers are in compliance with reasonably appropriate risk-based preventive controls that provide the same level of public health protection as those required under FSMA”.

But the devil would be in the detail, he said. “The FDA seems to be basing its thinking on an assumption of bilateral trade – whereas in fact most is multilateral. If you are importing chocolate from China, but the highest risk ingredient in it – the dairy protein – is in turn being imported by the Chinese company from New Zealand, the trail is dead in China.

“Far better that the FDA should pump all available resources into the VQIP - which I see as a kind of frequent traveler pass for trusted players to expedite entry into the US of imported food from eligible, qualified importers.”

Re-examination fees: Food import user fee by the back door?

Under FSMA, FDA can now charge food importers a fee (based upon an hourly rate of $224 or $325 if foreign travel is required) for any ‘re-examination’ required because FDA discovered a problem during an initial examination, noted England.

While this seemed eminently reasonable, he said, FDA has such a broad definition of what constitutes the ‘first examination’ that “virtually every imported food shipment detained for an apparent food safety reason will become subject to a re-examination fee”.

For example, FDA’s ‘first examination’ definition includes tasks and operations that “clearly do not involve any FDA inspection of the imported food at all, such as reviewing sample results from a third party, reviewing any relevant epidemiological evidence, reviewing a third party facility inspection, and almost any activity related to an FDA import alert”, he claimed

“FDA could not convince Congress to give the agency a food importation user fee so FDA made one up out of the re-examination fee language of FSMA… FDA appears to be looking at this fee requirement as a simple means to capture additional operational funds through a user fee system rejected by Congress in other food safety bills.”

Click here for more information on how FSMA affects imports.

Click here to find out more about a new series of webinars hosted by the Food Institute and OFW Law on the implementation of FSMA. The first webinar runs on February 6 at 12.00 EST.

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