The new rules, drafted by the Food and Drug Administration, were mandated by far-reaching legislation passed by Congress in late 2010. They represent one piece in a broader effort to overhaul the nation's approach to food safety for the first time in generations by preventing contamination and illness rather than simply reacting to outbreaks.
"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 regulations proposed Friday, domestic importers for the first time would have to vouch for the food-safety practices of their overseas suppliers. The new 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 different 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 realistically 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. It's just not doable."
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 former FDA official. He said the agency does the best it can under current law, but "there's a lack of understanding where the risks lie.We don't know what we don't know."
The proposed rules published Friday 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, for the first time, 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 then 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 FDA proposed in January governing domestic food production. Those rules, which stretched 1,200 pages and have yet to be finalized, 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 before being released Friday, much to the frustration of consumer advocates and some FDA officials. During that time, 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. "The longer it takes, the more people are going to get sick."
All told, 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 new proposals. In reality, it could take years before the sort of food-safety system the FDA envisions takes shape. The comment period for the domestic food rules already 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."
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