US New Guidelines for Regulating Imported Food and Drug Safety

The US Food and Drug Administration (FDA) Commissioner Margaret Hamburg said the agency will adopt a new regulatory approach to imported food and drug safety. The new approach takes into account the complexity of the entire supply chain and product safety issues at every point in the supply chain. The bureau believes that it is not possible to rely on a small number of inspectors to detect problems at border or foreign factories, and it is necessary to implement a system that can prevent problems before they happen.

The FDA works with regulators, manufacturers and suppliers around the world and now has permanent offices in China, India, Costa Rica, Mexico, and Chile, and is expanding to Jordan in the short term to help strengthen the ability to monitor product safety in these regions. The FDA has signed more than 30 agreements with foreign regulators to share inspection reports and other non-public information to make better decisions about the safety of foreign products.

Hamburg stresses that importers are also responsible for their supply chain; there are already some examples of good work practices that are pursued by some companies, and there is a need to become a standard operating method for the entire industry. FDA plans to work with industry to develop technology standards that help strengthen supply chain security.

FDA has launched a new online risk assessment tool, the English abbreviation "PREDICT", to help auditors lock in high-risk goods for inspection and speed up the clearance of low-risk goods (provided that importers and customs agents must provide accurate and complete information). This PREDICT system takes into account various factors, whether the product is at high risk (such as raw seafood), and even the FDA's data from past shippers or manufacturers inspection results will be covered. The FDA may also enter other information such as flooding, hot weather or market conditions. The inspector will take the risk scores based on various factors and take the lead in dealing with the goods with high risk.

The PREDICT system was piloted in Los Angeles and is now being implemented in New York. It is expected to expand to all parts of the United States by the end of the spring.