Regulation and the U.S.–China Dynamic

In its inspections, the FDA now uses a standard for food safety, formerly used for food aesthetics, called “otherwise unfit for food.” Due to increasing public demand for food safety, as well as changing expectations at the FDA, food producers in China and other countries must now exercise more collective responsibility throughout the supply chain. They must know the origin of food commodities, verify production compliance with all applicable U.S. laws, and supply all required documentation, including the food manufacturer registration number.

Producers in China must also be prepared to deal with the growing regulatory shift to computer-assisted risk analysis, which includes systems such as the FDA’s Prior Notice System Interface and the anticipated Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting system. To pass such computer-assisted assessments, food exporters must be able to track and document, to the satisfaction of the FDA, the path of food products “from farm to fork.” This information is vital for compliance with the second half of the food regulatory equation: proper documentation for import into the U.S.

Import Standards

In May 2009, the FDA finalized a rule and compliance policy guide explaining the new requirements for food imported, or offered for import, into the United States. These new rules build on the FDA’s authority to reject imported food products. Differences between the FDA rules and those of the Customs and Border Protection (CBP) agency can be confusing and challenging for Chinese exporters.

The new rules require that the FDA be given prior notice of the importation of food: a minimum of two hours for arrival by road, four hours for arrival by air or rail, and eight hours for arrival by water. Maximum notice times range from 15 to 30 days.

The new rules also require facilities to register with the FDA if they manufacture, process, pack, or hold food for human or animal consumption in the United States. For example, food that is not in its natural state may not be imported into the United States unless the FDA receives the name of the manufacturer and either the registration number, city, and country of the manufacturer, or the full address and the reason the registration number is not provided. The FDA’s list of acceptable reasons for not providing a registration number is very limited.

Failure to provide prior notice of imports can result in the United States refusing entry of the food. If entry is denied, the food will be held at the port of entry, unless the CBP agrees that it may be exported under its supervision, or either the FDA or CBP directs delivery to another location. The FDA can also bring civil or criminal charges in federal court or seek debarment of an importer. Importers should remember that if they attempt to bring in food articles from a food manufacturer that is not registered (so that the importer cannot provide its registration number), entry might be refused because the identity of the facility is incomplete. Clearly, importers must know the identity of the manufacturer and its registration number.

The CBP’s requirement that the “country of origin” of the food be identified can be confusing. “Country of production” and “country of origin” are not the same. For example, if beans grown in the United States are sent to China to be canned and then exported back to the United States, the CBP “country of origin” is the United States, but the FDA “country of production” is China. In this case, the FDA defines the “article of food” as canned beans.