“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.”
Some of the largest players in the food industry have supported the new regulations and have lobbied the White House to move forward with them quickly.
“We’re a large, international company, with operations in 65 countries and over 1,000 food-producing facilities. For us, having consistency in our food-safety-management systems is essential,” said Michael Robach, vice president for food safety at Cargill. He said most companies work hard to make sure their products are safe. “But some people aren’t doing it. We’d like to see a level playing field.”
The imported food proposals come on the heels of other standards the FDA proposed in January, governing domestic food production. Those rules would affect everyone from fruit and vegetable farmers to major food processing operations. For example, produce farmers would have to ensure that their crops aren’t contaminated by animal waste or a tainted water supply; they also would have to provide adequate restrooms and hand-washing facilities for field workers. Food manufacturers would face stricter sanitation standards, from increased bathroom cleanliness rules to more stringent pest-control requirements.
The proposed import rules, like the domestic versions before it, languished at the administration’s Office of Management and Budget for more than a year, much to the frustration of consumer advocates and some FDA officials. The process grew so drawn out that the nonprofit Center for Food Safety sued the FDA for missing deadlines set by Congress. Last month, a federal judge in California agreed and ordered the agency to unveil all its food-safety proposals by late this year and finalize new rules by mid-2015.
While the latest rules were pending, numerous outbreaks involving foreign imports have sickened hundreds of Americans — including pomegranates from Turkey that have caused hepatitis A and mangoes from Mexico contaminated with salmonella.
“We want these rules finalized as soon as possible. With the delays we’ve had, we’ve seen outbreak after outbreak,” said Sandra Eskin, director of the food-safety campaign at the Pew Charitable Trusts.
Contaminated foods sicken an estimated 48 million Americans and kill 3,000 each year.
FDA plans to accept comments for the next 120 days on the proposals. It could take years before the sort of food-safety system the FDA envisions takes shape. The comment period for the domestic food rules has been extended multiple times, and given the gridlock on Capitol Hill, it remains uncertain whether the agency will get the funding it says it needs to put the law in place.
“If we don’t get the resources to adequately implement these rules,” the FDA’s Taylor said, “we won’t be able to implement them.”