By Dan Bolton
A spring cleaning of the Food and Drug Administration’s (FDA) foreign food facilities database eliminated more than a quarter of registered food suppliers (28%), an unusually high number that possibly foretells even larger reductions of registered foreign-based suppliers in 2018.
The FDA database (as of February 2, 2017) listed 149,933 registered food facilities, a number than includes all coffee and tea processing locations in the US. Approximately 47% were outside of the United States (70,976). In the previous purge, done in 2014, only 14% of the food processing firms were deleted.
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Even more telling is the fact that only 9% of the attrition was domestic food facilities. Attrition was very high among foreign suppliers.
• Mexico – 53% drop (9,575 down to 4,499 registered food facilities)
• China – 46% drop (9,667 down to 5,236)
• India – 44% drop (3,455 down to 1,944).
• Italy – 39% drop (10,125 down to 6,169)
• Canada – 38% drop (6,690 down to 4,169)
Attrition, mergers, and forgetfulness all contribute to churn. Foreign firms that cease doing business typically do not cancel their registration, they simply do not renew and are purged. Food facilities located outside the US are now required to designate a US agent for FDA communications in their registration renewal. Many foreign firms did not comply by the Dec. 31, 2016, deadline.
A reason for additional concern are provisions of the Food Safety Modernization Act (FSMA) require that all foreign suppliers comply with US regulations. Should an importer become aware of non-compliance by one of its approved suppliers, the importer must ensure corrective action is taken. FSMA’s foreign supplier verification program requirements are effective next year. At that time US agents of foreign firms that meet the definition of importers will have to ensure that food and dietary ingredients imported into the US meet applicable US food safety standards, including having a preventive controls plan in place.
The challenge is that foreign suppliers were not previously required to complete a detailed food safety assessment. To be in compliance, exporters must analyze their products for possible hazards, provide product histories and other relevant information and pass that on to US based importers.
“Unlike in previous years, individuals or entities listed as US Agents in 2016 were required to confirm with FDA acceptance of their designation and corresponding responsibility,” explains David Lennarz, vp Registrar Corp. “FDA did not consider a facility’s 2016 renewal confirmed unless the designated US agent affirmatively agreed in writing. If a foreign facility submitted its registration renewal but its US agent did not affirmatively agree, its registration was removed from FDA’s food facility registration database,” he writes. Manufacturing, processing, packing, or storing food for US consumption without a valid FDA registration is a prohibited act, he writes.