“This is a huge paradigm shift,” Michael R. Taylor, the Food and Drug Administration’s top food-safety official, said in an interview. “It’s a very big step that we’re taking in building the food-safety system of the future. . . . We think it’s important for public health, but we also think it’s important for public confidence.”
Under the proposed rules, domestic importers would have to vouch for the food-safety practices of their overseas suppliers. The rules also aim to improve the consistency and transparency of foreign food-safety audits, which many companies rely on to ensure the quality of their international supply chains.
The proposals come at a time when the global food system has grown more complex and interconnected than ever, and when the volume of food pouring into the United States from every corner of the world increases each year. According to the FDA, U.S. imports come from about 150 countries. Roughly 80 percent of the seafood, half the fresh fruits and 20 percent of the vegetables consumed in the United States come from overseas. Beef, poultry and some egg products are overseen by the U.S. Department of Agriculture.
The FDA has a growing but limited overseas presence, and while it has ramped up inspections of foreign food facilities in recent years, investigators can reach only a tiny fraction of suppliers in any given country.
“There’s no way that the China office, for example, can actually check the food being imported to the U.S.,” said Caroline Smith DeWaal, food-safety director for the Center for Science in the Public Interest. “It would be mission impossible.”
In addition, the FDA inspects less than 2 percent of the food that crosses the border into the United States.
“We don’t have good insight into what’s going on with imported foods because they are not inspected overseas in a meaningful way or really at the point of entry,” said David Acheson, a managing director for food safety at Leavitt Partners and a former FDA official. “There’s a lack of understanding where the risks lie. We don’t know what we don’t know.”
The rules are intended to leverage the agency’s limited resources by creating a set of standards and relying on U.S. companies and foreign governments to ensure that overseas importers abide by them.
If adopted, they would create a “foreign supplier verification program,” in which U.S. companies would have clear legal responsibility for making sure their overseas suppliers meet U.S. safety standards. They also would establish a system in which the FDA could authorize foreign governments and private companies to accredit third-party auditors who could inspect overseas manufacturers that have a troubled history or whose products are deemed “high risk.”