Odds favor rogue producers over underfunded, understaffed FDA, critics say
By Diedtra Henderson, Globe Staff | May 1, 2007
WASHINGTON -- Rogue exporters have had little trouble shipping suspect products into the United States because the chances of being caught by an underfunded and understaffed Food and Drug Administration are slim.
Critics say the massive pet food recall that has triggered scores of lawsuits , raised safety questions about consuming domestic pork, and spurred at least two federal raids is also the result of an FDA wedded to an outdated approach to food safety despite the emergence of new pathogens and globalization of the nation's food supply.
As a consequence, the nation has become a dumping ground for suspect imports, critics say, because suppliers know there's not much chance of being discovered by FDA inspectors.
Sometimes exporters take extra steps to avoid detection. Chinese manufacturers of melamine -- the industrial chemical that set off the recall -- told the Associated Press yesterday that it is routinely added to animal feed to "lower the production cost and increase nitrogen levels." According to the Chinese government, two Chinese suppliers blamed for one of the nation's largest pet food recalls simply lied -- they marked exports tainted with melamine as requiring no inspection, even though they could have been used for human or pet food production.
But such deception is usually not needed. Since 1997 , FDA officials say, they have examined just 1 to 1.5 percent of food imports, while shipments skyrocketed from more than 4 million entries in 1997 to more than 15 million in 2006 . Meanwhile, the FDA's regulatory affairs staff is getting leaner -- it shrank from a high of 4,003 full-time employees in the 2003 fiscal year to 3,488 this fiscal year. As a result, non criminal foreign and domestic inspections carried out by FDA Center for Food Safety and Applied Nutrition staffers amounted to 9,038 in 2005 , down from 11,566 just two years earlier.
The FDA rarely rejects such food ingredients from China, according to an AP analysis. They simply don't rank high on the agency's priority list of items to inspect, former employees say. And even if an inspector rejects ingredients at one port, the supplier can simply gamble that another port will not be so vigilant.
"These importers know their stuff is looked at very rarely," said William Hubbard , a former FDA associate commissioner who is working to increase congressional appropriations for the cash-strapped agency. " And even if FDA does catch them, all they can do is send the food back."
The picture is equally bleak for the FDA's rare inspections of foreign food manufacturing plants. Even if there were money to pay for inspectors to make site visits or visas to allow them to go, some employees are reluctant to volunteer for overseas trips.
"The whole thing, from a management perspective, is just a shipwreck," said Carl R. Nielsen , former director of the FDA division that handles import operations and policy.
Yesterday, Democratic leaders dispatched congressional investigators to West Coast ports to see how diligently the FDA inspects food products from China.
Mike Herndon , an FDA spokesman, said the agency has "no information to support the assertion" the nation has become a dumping ground for substandard foods and says all inspectors are required to perform foreign inspections. The 2007 fiscal year budget allotted greater resources for investigating imported foods than domestic food operations, Herndon said.
But critics say resolving most of the FDA's food safety woes will require an additional $400 million , and some congressional Democrats pledge to push for more.
Representative John D. Dingell , Democrat of Michigan , said the agency's field employees are growing increasingly disillusioned because they lack adequate funding to carry out their mission.
"The country is awash in dangerous food coming in from China and other places," Dingell said. He blames federal and White House leaders for turning the agency into "a ghost" by underfunding it.
"Everybody says [the FDA] is leaner and meaner. It is not meaner. It is leaner. And it is leaner to the point of extinction and vanishment," he said. Dingell, chairman of the House Energy and Commerce Committee, soon will introduce legislation that calls for user fees paid by exporters to cover the expense of food inspections.
Meanwhile, on the Senate side, Richard J. Durbin says he will offer a food safety amendment to a must-pass FDA bill expected to clear the Senate this week. Durbin , an Illinois Democrat, echoes FDA critics in saying the agency needs authority to require recalls. But the FDA also must conduct more and smarter inspections of imported food, targeting countries and foods that pose the highest risks, he said. Reports that Chinese suppliers have laced vegetable proteins with melamine for years is "proof positive the current system is not really adequate to the task," Durbin said.
But there are also problems beyond funding, says a former FDA attorney who reported to the agency's second-highest official.
"There is a culture issue there that they have to address," said Benjamin England , a 17-year FDA veteran who, like Nielsen , now consults for foreign exporters. "The agency has historically looked at the import program as the bastard stepchild."
In some respects, ChemNutra , the Las Vegas firm responsible for importing about 1.7 million pounds of Chinese wheat gluten tainted with industrial chemicals, was the ideal actor to set in motion a chain of events that triggered recalls of millions of cans and pouches of pet food. The young firm recently added wheat gluten to the portfolio of ingredients it imports and tapped trusted traders to identify a supplier based in China, Steve Miller , its chief executive , testified before Congress last week. The wild card for which neither ChemNutra, its customers, nor FDA was prepared was a supplier secretly boosting nitrogen levels by adding melamine , which is used to make plastics.
Menu Foods, a former ChemNutra client, for instance, only buys vegetable protein that tests confirm contains at least 75 percent protein. Adding melamine or cyanuric acid , a chemical used in pool cleaners, artificially inflates protein levels and the inferior product's price.
"For someone who knows how the industry testing methods work, this would allow them to cheat buyers," said Menu Foods Income Fund chief executive Paul K. Henderson , who also testified before Congress. "If it were not for the previously unknown toxicity of melamine in cats and dogs, the scam would have worked."
ChemNutra's Miller agreed: "This was an adulteration that was just off the radar screen. No one was aware of it. No one had thought of it," Miller told the US House oversight panel. "I don't believe it had ever been tested for in wheat gluten."
When inspectors analyze a product, a sophisticated computer readout compares peaks and valleys of the import's chemical "fingerprint" to a known reference sample. But wheat gluten is trickier, said Marc Ullman , ChemNutra's attorney. "St. John's Wort is St. John's Wort. Calcium is calcium," he said. "Everybody's wheat gluten is a little bit different."
The FDA last week began testing a half-dozen food ingredients imported from China for chemical contaminants, and some inspectors are poised to visit China.
But a longer list of food ingredients unlikely to get checked includes gum acacia , an emulsifier that shows up in the ingredients for chewing gum , candy bars, and ice cream . The tree from which is it produced grows in countries with "poorly developed" food regulation, said Hubbard.
And while US Customs says all ports use a uniformly rigorous risk-management strategy, making even a simple change to improve safety -- a "refused" stamp to mark imported products rejected by FDA as unsuitable for sale -- has proven difficult. Five years after Congress approved it, the measure still hasn't been implemented, Hubbard said.
Herndon, the FDA spokesman, said the proposed regulation is "undergoing legal review."