By Eric D. Hargan and Kevin Qian, Contributing Editors
Of the $80 billion worth of food that is imported into the United States each year (an amount equal to 15% of the country’s total food consumption), food and food products from China play an increasingly important role. In the past decade, the value of Chinese processed food and commodity imports has more than tripled, according to USDA, and China has more food facilities registered with FDA than either Canada or Mexico. This inevitably makes FDA approval crucial for China’s food product exporters, yet that approval is not a matter of inspection alone.
Over 17 million shipments of imported products of all kinds come into the United States every year, but FDA inspects just over 1% of those shipments. FDA, of course, understands this does not allow for a perfect inspection regime. But, because of the limited number of personnel FDA can deploy, and the limited number of inspections it can make, the agency relies increasingly on risk analysis, assisted by computers.
The FDA may, at any time, reject food based on examination, on a food producer’s prior history or even on the appearance of violating FDA standards. The clear implication is that, when food producers based in China, as well as in other countries, export to the United States, their first and most practical line of defense is to meet, as closely as possible, FDA production and safety standards in their own country of origin. An understanding of some of the key issues involved is essential for such compliance efforts.
Inspection standards
FDA may reject any food for import if it appears to be adulterated, misbranded or in violation of the law. The agency may require food that is noncompliant to be relabeled, reconditioned, refused, detained, seized or destroyed. All food manufacturing facilities exporting to the U.S. must conform to FDA’s Good Manufacturing Practices (GMP), which cover standards for worker sanitation, plant construction and cleanliness. When FDA conducts surveillance and investigation of a food processing facility for GMP compliance, it may review everything from production history and firm management to direct observation of “objectionable conditions” and “deficiencies” (to use language commonly used in FDA’s Form 483 inspection report). Inspection is carried out by a complex regulatory system that includes:
· FDA Center for Food Safety and Applied Nutrition (CFSAN), which regulates most food;
· FDA Office of Regulatory Affairs, FDA’s field agents, among other things;
· USDA Food Safety and Inspection Service ( FSIS), which inspects meat and poultry;
· USDA Animal and Plant Health Inspection Service (APHIS), which regulates animal and plant products.
