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Pet Deaths Spur Call for Better FDA Screening
Imports Raise Concern About Human Foods

By Rick Weiss and Ariana Eunjung Cha
Washington Post Staff Writers
Tuesday, May 1, 2007

Amid growing revelations that suppliers in China frequently spike pet food and other food ingredients with contaminants to boost profits, momentum is building in Washington to bolster the Food and Drug Administration's capacity to detect and screen out adulterated imports.

Several Chinese suppliers conceded over the weekend that adding melamine to pet food ingredients -- now blamed for the deaths of many animals in the United States and possible contamination of the human food supply -- is but the latest technique for fooling U.S. companies into thinking they are purchasing a high-quality product.

Before melamine there was urea, Chinese traders said -- another nitrogen-rich chemical that was used to give false high scores on tests of protein content but was abandoned after it made animals ill.

The task of guarding against contaminants in imports has become far more complicated because an increasing portion of the tens of billions of dollars in Chinese food and agricultural imports involves powders and concentrates for the processed-food industry -- including the wheat gluten and rice protein at the center of the pet food scandal. Animal feed imports alone grew sevenfold from 2001 to 2006, the Commerce Department says.

Such products pose three problems: Their makeup is not obvious by mere visual inspection; they can be easily and invisibly contaminated or intentionally spiked with chemicals that are not on the FDA's standard battery of tests; and their origins are often vague, because they have been through several stages of processing and trade.

Now an increasing number of legislators, scientists and others are saying it is time to modernize FDA's authority to trace the sources of food imports and punish scofflaws -- legal powers that experts say have barely evolved over the past 70 years.

Many also want to expand the agency's food-safety budget.

"I do think this pet food thing has shown people, including people at the very highest levels of the administration, that something needs to be fixed," said William Hubbard, associate director of the FDA from 1991 to 2005. "If this isn't a wake-up call, then people are so asleep they are catatonic."

Which new powers to give the FDA, however -- and how to spend any extra funding -- remains contentious. And some legislators want assurances that the agency is worthy of added support.

"Leadership has been missing for far too long, and that needs to change quickly," said Rep. Rosa DeLauro (D-Conn.), who chairs the subcommittee that funds the agency. Others have complained that Senate-confirmed FDA commissioners have been in place for less than one-third of President Bush's tenure.

Relying largely on laws passed in 1906 and 1938, which among other things empower it to detain "filthy, putrid or decomposed" foods, the FDA today oversees $1 trillion worth of products annually, including about half of all imports. The $2 billion agency regulates products that together account for fully 25 cents of every dollar American consumers spend, and sheer volume makes it impossible to inspect more than a small fraction of incoming food.

"It's a huge amount," said Dan Michels, a former director of the FDA's Office of Enforcement and now a Silver Spring-based regulatory consultant. "You can't even look at everything, let alone sample and test it."

About 99 percent of imported foods are simply acknowledged by computer and waved ashore.

Inspections were easier when imports were identifiable foods. Products that looked like oranges were clearly oranges, even if they sometimes had to be tested for pesticides. Raspberries were raspberries, even if some were tainted with bacteria.

But processed ingredients are often nondescript. And in China, where a national passion for commerce has far outpaced the adoption of regulatory controls, marketers have repeatedly been caught adulterating such products -- spiking pig feed with diet pill chemicals to make swine leaner, for example, and hiding sawdust in fishmeal.

Officials at Chinese companies that make melamine, which is used in plastics but can also give falsely elevated readings of a food's nutritional value, have acknowledged that the chemical is sometimes sold to makers of animal food ingredients.

"It's always been like that, people buying it as animal feed," said Xu Qin Bin, a sales representative for Shandong Sanhe Chemical Co.

Other melamine brokers said the standard policy is, in effect, one of "don't ask, don't tell."

"As long as you bring money, anyone can buy," said Zhao Yan of the Shandong Taian Ningyang County Weiye Chemical Co., which markets melamine.

A recent shift from old-fashioned trade fairs to online trading has facilitated this shadowy market by adding a layer of anonymity between producers and consumers.

By far the largest online marketplace in China, and perhaps the world, is Alibaba.com. It is based in the southeastern city of Hangzhou and specializes in business-to-business transactions. On Alibaba, buyers can order garden gnomes, customized political campaign buttons, bolts of taffeta, as well as wheat gluten and other foodstuffs -- all with a click of a mouse.

On a typical day, Alibaba vendors advertise about 1.75 million individual products, more than 30,000 of them agricultural.

Xuzhou Anying Biologic Technology Development Co. and Binzhou Futian Biology Technology Co., the two companies under investigation by Chinese and U.S. officials, sell vegetable proteins on Alibaba. Scores of others hawk wheat gluten, rice protein or corn gluten -- virtually all advertising their products as high-quality "feed grade," "food grade" or "export grade" and none offering inferior "industrial" grade.

In its ad, Xuzhou Anying, which American authorities say supplied toxic wheat gluten to pet food makers, does not specify what uses its wheat gluten is meant for. But it cites "feed additives" as one of its main exports and claims that its gluten is "reference grade three a" -- a term that FDA officials say has no formal regulatory meaning.

When reached by phone, seven wheat gluten companies advertising on Alibaba declined to answer specific questions about where their products come from.

That kind of opacity poses enormous challenges to pet food makers, said Rodney Noel, a state chemist in Indiana and a member of the pet food committee of the Association of American Feed Control. "How can these companies know the source?" Noel asked. "They don't necessarily know if it came from China or Timbuktu."

It also poses problems for the FDA, which has limited authority to demand records identifying the sources of food.

But that is just one of many ways in which the agency is hobbled, experts said. Another: Despite a temporary post-Sept. 11, 2001, staff increase inspired by fears of terrorist attacks on food, the number of FDA employees working on port inspections has returned to pre-Sept. 11 levels -- part of a gradual shriveling of the agency's food safety division relative to its burgeoning pharmaceutical branch.

Moreover, while the Agriculture Department -- which has parallel responsibilities for imported beef and poultry -- has the legal authority to designate 10 U.S. ports as the only ones eligible to accept foreign meat, allowing its inspectors to focus their efforts in those places, FDA inspectors -- who are far fewer in number -- must cover every U.S. border crossing.

Inspectors would also benefit from portable high-speed analyzers. Most samples today are sent overnight to distant labs. And because officials can sideline only those shipments they deem suspicious, imported foodstuffs are typically well into the chain of commerce by the time test results come back.

That problem is exacerbated by FDA's lack of authority to order recalls, which means it must rely on the cooperation of companies when products need to be pulled off shelves. And that assumes the agency has managed to detect a contaminant, which is not easy.

"There is this popular assumption -- maybe it comes from people watching 'CSI' -- that you can put a sample in a machine and get all the answers," said Michels, the consultant. "Unfortunately, it's not like that." You have to have some idea of what you might be looking for."

Congress has a variety of avenues open to it as it considers how to strengthen the beleaguered agency. One is to make permanent some provisions of the Bioterrorism Act of 2002. In response to the pet food crisis, the FDA invoked the act recently for the first time -- not because of any suspicion that bioterrorism was at play but because of the added powers it provides to obtain shipping records and detain shipments.

Some advocates want an expansion of the so-called Hazard Analysis and Critical Control Point (HACCP) program that USDA uses to prevent microbial contamination of meat and poultry, and which the FDA recently adopted for imported seafood. The program makes companies legally liable for identifying where contamination is likely to occur and instituting suitable controls at those points.

"As long as the system depends on government inspectors to detect problems and pull dangerous foods, it's a failed system," said Michael Taylor, former director of the Agriculture Department's Food Safety and Inspection Service and a former FDA deputy commissioner. HACCP, Taylor said, "allows us to hold companies accountable."

Discussion of enhancements could start this week, as Congress begins to debate reauthorizing the Prescription Drug User Fee Act, a controversial program that aims to speed drug approvals with injections of pharmaceutical company money.

"We need to take FDA from being a toothless agency to one with the authority to act to protect the public health," DeLauro said.

That effort could still stall, but it is riding a wave it never thought it would catch: a wellspring of concern for the nation's dogs and cats.

Staff writer Nancy Trejos and researcher Crissie Ding contributed to this report. Cha and Ding reported from China.

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