Third of three parts
WEDNESDAY, Jan. 16, 2008 (HealthDay News) -- With every new recall of yet another staple of the American diet, demands for a solution to the food safety problem are becoming more strident.
The proposals for fixes range from reconstructing the U.S. Food and Drug Administration into a more powerful policing agency to reshaping the food industry so it can better monitor itself.
All ideas seek to modernize a system that seems to have become hopelessly outdated.
"Food is not produced, processed or distributed the way it was 20 to 30 years ago," said Dr. Pascal James Imperato, a former New York City health commissioner who now heads the department of preventive medicine and community health at the State University of New York Downstate Medical Center in New York City. "Farming is now a major agribusiness, and it introduces a variety of problems that didn't exist before. It's much more complicated and can't be addressed by regulations that were written 30 years ago."
Further straining efforts to safeguard U.S. consumers is the nation's growing appetite for imported foods. Americans now consume $70 billion worth of foods from abroad, up from $36 billion just a decade ago.
The current hodgepodge of food regulations were simply adopted as the need arose, experts say.
"You have a system that developed organically from the turn of the [20th] century," explained Jessica Milano, who wrote a report on food safety, Spoiled: Keeping Tainted Food Off America's Tables, that was published in September by the nonprofit Progressive Policy Institute. "As economies developed with more commercial food manufacturers and multi-ingredient products, you have some overlaps and redundancies."
Those overlaps and redundancies have left regulators and producers unable to guarantee the safety of all foods sold in the United States, critics contend.
Solutions to the problem fall into two broad categories: government-mandated reforms and reforms generated by the food industry itself. How these reforms would be implemented depends on whether the food is grown domestically or abroad.
The most widely discussed reforms include creating a new "superagency" that would oversee food safety (right now that responsibility is divided between the FDA and the U.S. Department of Agriculture); increasing funding, and thereby staffing, at the FDA; and giving the FDA recall authority for tainted food products.
For its part, the Grocery Manufacturers Association, which represents the nation's top food producers, unveiled a four-pronged plan in September that it said was designed to better safeguard food imports. Features include giving foreign countries and firms with good safety records expedited clearance through U.S. inspections, thereby allowing the FDA to "focus more on products that present the biggest risk;" and bolstering efforts within foreign countries to improve safety standards overseas.
A Federal 'Superagency' With Oversight
The most frequently mentioned reform calls for bringing food inspections under one tent. Right now, the FDA and the USDA work in separate, often overlapping, fiefdoms when it comes to overseeing food safety. Complicating matters, the USDA receives 80 percent of the food safety budget to regulate 20 percent of the food supply, while the FDA receives 20 percent of the budget to oversee 80 percent of the nation's food.
The idea of such a "superagency" has numerous supporters, including Sen. Carl Levin (D-Mich.), chairman of the Homeland Security and Governmental Affairs Committee's Permanent Subcommittee on Investigations.
"[Federal agencies] are stumbling over themselves," Milano said. "There's a huge opportunity for efficiencies to be gained by having one agency with one clear mandate."
Michael Doyle, a microbiologist who is director of the Center for Food Safety at the University of Georgia in Griffin, agreed.
"There really needs to be a single food safety agency so that you don't have all of this ridiculous overlap and duplication," he said. "When you have it split up into different agencies like that, there's a lot of bureaucratic infighting."
Such a merger would also address the current imbalance in agency budgets and responsibilities. The FDA's food inspection division -- which most agree is woefully underfunded -- is charged with inspecting all foods except for meat, poultry and eggs, which are covered by the better-funded USDA.
Although the "superagency" concept has been implemented in other countries, many observers doubt this will happen in the United States.
"There appears to be no industry support, so that isn't going to go anywhere," said Michael Hansen, senior scientist with Consumers Union.
"There has to be the will within the Congress to do this, and the executive branch has to be willing to tackle this," Imperato said. "Unless they do, it's just going to be business as usual, [and] that's what I've seen so far."
Asked about creating one oversight agency for food inspection, Michael Rogers, director of the FDA's Office of Field Investigations, said a spirit of cooperation -- not confusion -- best describes the relationship between the two agencies. "I think that both agencies understand their roles and responsibilities," he said.
Rogers' counterpart at the USDA agreed. "The goal right now is to continue to increase the collaboration between the agencies to continue to improve the food-safety system," said Dr. Roger Raymond, Undersecretary for Food Safety at the agency.
Calls for FDA Recall Authority
Then there's the issue of the FDA and mandatory recall authority. Every recent recall -- from spinach to baker's chocolate -- has been voluntary on the part of the manufacturer or distributor. The only food item the FDA has the authority to recall is infant formula.
An obvious fix would be to grant that authority. Is that likely?
In November, FDA officials released a set of proposals known as the Food Protection Plan, in which it called for recall authority for food products, but that plan is still making its way through Congress.
"I believe the FDA will someday receive mandatory recall authority, but it may be a year or two before this happens," said Doyle. "An act of Congress will be needed to authorize FDA recall authority."
However, one former FDA commissioner doesn't think recall authority would make much of a difference.
"It's helpful, but the professionals at FDA say that recall authority is way overblown in importance, because [the] FDA usually goes to a producer and says, 'We found a problem with your food and we need to recall it,' and the producers always do it," said Bill Hubbard, who was associate commissioner at the FDA for 14 years before retiring in 2005.
Overseeing Imported Foods
The solutions to the problems with imported foods basically mirror those for domestically grown foods -- creating a federal oversight superagency, a more balanced distribution of funding and duties between the FDA and the USDA, and granting the FDA recall authority.
The need for solutions is taking on added urgency, with the consumption of imported foods soaring in the last 10 years. Government statistics show that from 2003 to 2005 alone, food imports rose from 9.3 million shipments a year to 13.8 million shipments annually. Now, imported foods make up 13 percent of the typical American diet.
But, according to Milano, "as the volume of imports keeps rising but the number of [FDA] inspectors doesn't, the percentage of foods that is actually getting checked is getting squeezed."
The FDA's own statistics show that its inspectors sample only 1.3 percent of all food being sent to the United States from other countries.
Short of creating one federal "superagency," another obvious solution: Give the FDA, especially, more cash to boost the number of inspectors and inspections of imported goods.
That sounds simple. However, in testimony delivered at a congressional hearing recently on the issue of food safety, U.S. Department of Health and Human Services Secretary Mike Leavitt went on record as saying that, "We cannot inspect our way to safety."
"The federal government cannot, and it should not, attempt to physically inspect every product that enters the United States," he said. "Doing so would bring the international trade of this country to a standstill."
Still, the agency's critics say the FDA would only gain from more funding and from broader powers to monitor foods from abroad.
The third, and least radical, alternative for improving oversight of imported foods: Give the agency recall authority. The FDA routinely recalls bad drugs from the market, but it has no such jurisdiction over bad food -- with the exception of infant formula.
"Now, if you're some little firm in China, and you know that there is no mandatory [FDA] recall authority, odds are you aren't going to get caught, so you can dump your less standard products in the U.S. with little recourse to who's going to track them down or enforce it," Milano said.
U.S. Inspectors Defend Their Performance
All three recommendations -- as well as others, such as country-of-origin labeling and instituting so-called equivalency standards that would demand that imported foods be as safe as domestic products -- are already making their way through Congress as part of a bill introduced by Rep. John Dingell, a Michigan Democrat and chairman of the Energy and Commerce Committee.
The bill would also limit the number of U.S. ports that foreign foods could enter to only those equipped with FDA laboratories to help cut down on so-called "port-shopping," where importers move shoddy products from one port to the next, hoping to eventually slip the product by inspectors.
For their part, federal inspectors say they're up to the challenges of monitoring food imports.
Rogers, whose office oversees the inspection of imported goods, said his agency "is doing an excellent job, given our resource challenges."
"Certainly, I will concede that an agency with more can do more," Rogers said. But more inspections are "not the panacea for total public health protection," he added. "There are opportunities to interact with foreign governments, opportunities to collaborate with the states, to interact with those other agencies that have overlapping responsibilities -- it's all part of a network."
Raymond added that USDA teams are already working with officials at the U.S. Department of Homeland Security and Customs and Border Control on a computerized system that should boost the detection of hazardous imported goods.
As for granting the FDA recall authority, Rogers said it may not be necessary. Products made by foreign firms that resist FDA oversight are quickly targeted by the agency for inspection at the border, he noted. In that sense, "an inspection dictates whether or not a firm will have access to the U.S. market," he said.
Efforts to boost the safety of imported food will also hinge on global partnerships.
A case in point: In October, FDA Commissioner Dr. Andrew von Eschenbach and others met with their Chinese counterparts to discuss import safety. In December, the two countries signed an agreement that places new registration and inspection requirements on 10 food products exported by Chinese companies. Those products include some preserved foods, pet foods and farm-raised fish, all of which have been suspected of being tainted.
Despite continuing reports of food recalls and contaminations, the United States still has the safest food supply in the world, von Eschenbach stressed.
"But we realize the world is changing," von Eschenbach acknowledged during a November 2007 teleconference after the FDA presented its Food Protection Plan to the White House. "There was a time when we produced the food ourselves. Now we've noticed that much of this food comes to us 365 days a year, because it is being produced in other parts of the world.
"Globalization has radically changed our food supply and our food-supply chain," von Eschenbach added. And that means, he said, that the FDA needs to catch up with those changes.