[secondmortgagek]

It's Not Just Pet Food

By Peter Kovacs
The Washington Post
Monday, April 23, 2007; A17

Lost amid the anxiety surrounding the tainted U.S. pet food supply is this sobering reality: It's not just pet owners who should be worried. The uncontrolled distribution of low-quality imported food ingredients, mainly from China, poses a grave threat to public health worldwide.

Essential ingredients, such as vitamins used in many packaged foods, arrive at U.S. ports from China and, as recent news reports have underscored, are shipped without inspection to food and beverage distributors and manufacturers. Although they are used in relatively small quantities, these ingredients carry enormous risks for American consumers.

One pound of tainted wheat gluten could, if undetected, contaminate as much as a thousand pounds of food.

Unlike imported beef, which is inspected at the point of processing by the U.S. Agriculture Department, few practical safeguards have been established to ensure the quality of food ingredients from China.

Often, U.S. officials don't know where or how such ingredients were produced. We know, however, that alarms have been raised about hygiene and labor standards at many Chinese manufacturing facilities. In China, municipal water used in the manufacturing process is often contaminated with heavy metals, pesticides and other chemicals. Food ingredient production is particularly susceptible to environmental contamination.

Equally worrisome, U.S. officials often lack the capability to trace foreign-produced food ingredients to their source of manufacture. In theory, the Bioterrorism Prevention Act of 2001 provides some measure of traceability. In practice, the act is ineffective and was not designed for this challenge. Its enforcement is also shrouded in secrecy by the Department of Homeland Security.

Even if Food and Drug Administration regulators wanted to crack down on products emanating from the riskiest foreign facilities, they couldn't, because they have no way of knowing which ingredients come from which plant. This is why officials have spent weeks searching for the original Chinese source of the contaminated wheat gluten that triggered the pet food crisis.

That it was pet food that got tainted -- and that relatively few pets were harmed -- is pure happenstance. Earlier this spring, Europe narrowly averted disaster when a batch of vitamin A from China was found to be contaminated with Enterobacter sakazakii, which has been proved to cause infant deaths. Thankfully, the defective vitamin A had not yet been incorporated into infant formula. Next time we may not be so fortunate.

Currently, most of the world's vitamins are manufactured in China. Unable to compete, the last U.S. plant making vitamin C closed a year ago. One of Europe's largest citric acid plants shut last winter, and only one vitamin C manufacturer operates in the West. Given China's cheap labor, artificially low prices and the unfair competitive climate it has foisted on the industry, few Western producers of food ingredients can survive much longer.

Western companies have had to invest heavily in Chinese facilities. These Western-owned plants follow strict standards and are generally better managed than their locally owned counterparts. Nevertheless, 80 percent of the world's vitamin C is now manufactured in China -- much of it unregulated and some of it of questionable quality.

Europe is ahead of the United States in seeking greater accountability and traceability in food safety and importation. But even the European Union's "rapid alert system" is imperfect. Additional action is required if the continent is to avoid catastrophes.

To protect consumers here, we must revise our regulatory approaches.

The first option is to institute regulations, based on the European model, to ensure that all food ingredients are thoroughly traceable. We should impose strict liability on manufacturers that fail to enforce traceability standards.

A draconian alternative is to mount a program modeled on USDA beef inspection for all food ingredients coming into the country. This regimen would require a significant commitment of resources and intensive training for hundreds of inspectors.

Food safety is a bipartisan issue: Congress and the administration must work together and move aggressively to devise stricter standards. Rep. Henry Waxman (D-Calif.), chairman of the House Government Reform Committee, has deplored dangerous levels of lead in vitamin products originating in China. We must get to the bottom of this pressing public health issue, without self-defeating finger-pointing.

The United States is sitting on powder keg with uncontrolled importation and the distribution of low-quality food ingredients. Before it explodes -- putting more animals and people at risk -- corrective steps must be taken.

The writer was president of NutraSweet Kelco Co. from 1994 to 1997. He is a management consultant to many large food ingredient companies.

© 2007 The Washington Post Company

http://www.washingtonpost.com/wp-dyn...042201163.html

[hotelhyatt]

While China cleans up it's act, people should learn to shun food with "ingredients". Learn to cook. Buy fresh, simple stuff. Read labels. Support local farmers. Stay away from vitamins.

It's not difficult.

[RlUbQU3R]

This regimen would require a significant commitment of resources and intensive training for hundreds of inspectors.

...which the food companies should be required to pay for without passing the cost to the consumer.

Maybe some of the food processing industry would return stateside in that case.

[Sipewrio]

People in NYC cook? There's a reason that there's a Chinese take out place, a pizzeria, and a sushi bar on every block. People don't even cook with bad ingredients.

While China cleans up it's act, people should learn to shun food with "ingredients". Learn to cook. Buy fresh, simple stuff. Read labels. Support local farmers. Stay away from vitamins.

It's not difficult.

[Lkemybab]

Fab, sometimes it is not the cooking itself that is difficult, but the space and time to do it in.

For me it is the cleanup. I hate that!!!


(Edit: Not that we DON'T cook mind you!!!)

[pobrierce]

I meant to say, "...have your staff learn to cook".

[hHwJ229h]

I meant to say, "...have your staff learn to cook".

My wife will beat you up for that!

[Jellowstrom]

The New York Times
April 30, 2007

Filler in Animal Feed Is Open Secret in China


Pieces of melamine displayed by a worker.
The melamine is ground into a powder and added to animal feed as a filler to keep costs low.


By DAVID BARBOZA and ALEXEI BARRIONUEVO

ZHANGQIU, China, April 28 — As American food safety regulators head to China to investigate how a chemical made from coal found its way into pet food that killed dogs and cats in the United States, workers in this heavily polluted northern city openly admit that the substance is routinely added to animal feed as a fake protein.

For years, producers of animal feed all over China have secretly supplemented their feed with the substance, called melamine, a cheap additive that looks like protein in tests, even though it does not provide any nutritional benefits, according to melamine scrap traders and agricultural workers here.

“Many companies buy melamine scrap to make animal feed, such as fish feed,” said Ji Denghui, general manager of the Fujian Sanming Dinghui Chemical Company, which sells melamine. “I don’t know if there’s a regulation on it. Probably not. No law or regulation says ‘don’t do it,’ so everyone’s doing it. The laws in China are like that, aren’t they? If there’s no accident, there won’t be any regulation.”

Melamine is at the center of a recall of 60 million packages of pet food, after the chemical was found in wheat gluten linked this month to the deaths of at least 16 pets and the illness of possibly thousands of pets in the United States.

No one knows exactly how melamine (which is not believed to be particularly toxic) became so fatal in pet food, but its presence in any form of American food is illegal.

The link to China has set off concerns among critics of the Food and Drug Administration that ingredients in pet food as well as human food, which are increasingly coming from abroad, are not being adequately screened.

“They have fewer people inspecting product at the ports than ever before,” says Caroline Smith DeWaal, the director of food safety for the Center for Science in the Public Interest in Washington. “Until China gets programs in place to verify the safety of their products, they need to be inspected by U.S. inspectors. This open-door policy on food ingredients is an open invitation for an attack on the food supply, either intentional or unintentional.”

Now, with evidence mounting that the tainted wheat gluten came from China, American regulators have been granted permission to visit the region to conduct inspections of food treatment facilities.

The Food and Drug Administration has already banned imports of wheat gluten from China after it received more than 14,000 reports of pets believed to have been sickened by packaged food. And last week, the agency opened a criminal investigation in the case and searched the offices of at least one pet food supplier.

The Department of Agriculture has also stepped in. On Thursday, the agency ordered more than 6,000 hogs to be quarantined or slaughtered after some of the pet food ingredients laced with melamine were accidentally sent to hog farms in eight states, including California.
The pet food case is also putting China’s agricultural exports under greater scrutiny because the country has had a terrible food safety record.

In recent years, for instance, China’s food safety scandals have involved everything from fake baby milk formulas and soy sauce made from human hair to instances where cuttlefish were soaked in calligraphy ink to improve their color and eels were fed contraceptive pills to make them grow long and slim.

For their part, Chinese officials dispute any suggestion that melamine from the country could have killed pets. But regulators here on Friday banned the use of melamine in vegetable proteins made for export or for use in domestic food supplies.

Yet what is clear from visiting this region of northeast China is that for years melamine has been quietly mixed into Chinese animal feed and then sold to unsuspecting farmers as protein-rich pig, poultry and fish feed.

Many animal feed operators here [China] advertise on the Internet, seeking to purchase melamine scrap. The Xuzhou Anying Biologic Technology Development Company, one of the companies that American regulators named as having shipped melamine-tainted wheat gluten to the United States, had posted such a notice on the Internet last March.

Here at the Shandong Mingshui Great Chemical Group factory, huge boiler vats are turning coal into melamine, which is then used to create plastics and fertilizer.

But the leftover melamine scrap, golf ball-size chunks of white rock, is sometimes being sold to local agricultural entrepreneurs, who say they mix a powdered form of the scrap into animal feed to deceive those who raise animals into thinking they are buying feed that is high in protein.

“It just saves money if you add melamine scrap,” said the manager of an animal feed factory here.

Last Friday here in Zhangqiu, a fast-growing industrial city southeast of Beijing, two animal feed producers explained in great detail how they purchase low-grade wheat, corn, soybean or other proteins and then mix in small portions of nitrogen-rich melamine scrap, whose chemical properties help the feed register an inflated protein level.

Melamine is the new scam of choice , they say, because urea — another nitrogen-rich chemical — is illegal for use in pig and poultry feed and can be easily detected in China as well as in the United States.

“People use melamine scrap to boost nitrogen levels for the tests,” said the manager of the animal feed factory. “If you add it in small quantities, it won’t hurt the animals.”

The manager, who works at a small animal feed operation here that consists of a handful of storage and mixing areas, said he has mixed melamine scrap into animal feed for years.

He said he was not currently using melamine. But he then pulled out a plastic bag containing what he said was melamine powder and said he could dye it any color to match the right feed stock.

He said that melamine used in pet food would probably not be harmful. “Pets are not like pigs or chickens,” he said casually, explaining that they can afford to eat less protein. “They don’t need to grow fast.”

The resulting melamine-tainted feed would be weak in protein, he acknowledged, which means the feed is less nutritious.

But, by using the melamine additive, the feed seller makes a heftier profit because melamine scrap is much cheaper than soy, wheat or corn protein.

“It’s true you can make a lot more profit by putting melamine in,” said another animal feed seller here in Zhangqiu. “Melamine will cost you about $1.20 for each protein count per ton whereas real protein costs you about $6, so you can see the difference.”

Feed producers who use melamine here say the tainted feed is often shipped to feed mills in the Yangtze River Delta, near Shanghai, or down to Guangdong Province, near Hong Kong. They also said they knew that some melamine-laced feed had been exported to other parts of Asia, including South Korea, North Korea, Indonesia and Thailand.

Evidence is mounting that Chinese protein exports have been tainted with melamine and that its use in agricultural regions like this one is widespread. But the government has issued no recall of any food or feed product here in China.

Indeed, few people outside the agriculture business know about the use of melamine scrap. The Chinese news media — which is strictly censored — has not reported much about the country’s ties to the pet food recall in the United States. And few in agriculture here [China] do not see any harm in using melamine in small doses; they simply see it as cheating a little on protein, not harming animals or pets.

As for the sale of melamine scrap, it is increasingly popular as a fake ingredient in feed, traders and workers here say.

At the Hebei Haixing Insect Net Factory in nearby Hebei Province, which makes animal feed, a manager named Guo Qingyin said: “In the past melamine scrap was free, but the price has been going up in the past few years. Consumption of melamine scrap is probably bigger than that of urea in the animal feed industry now.”

And so melamine producers like the ones here in Zhangqiu are busy.

A man named Jing, who works in the sales department at the Shandong Mingshui Great Chemical Group factory here, said on Friday that prices have been rising, but he said that he had no idea how the company’s melamine scrap is used.

“We have an auction for melamine scrap every three months,” he said. “I haven’t heard of it being added to animal feed. It’s not for animal feed.”

David Barboza reported from Zhangqiu and Alexei Barrionuevo reported from Chicago. Rujun Shen also contributed reporting from Zhangqiu.

Copyright 2007 The New York Times Company

http://www.nytimes.com/2007/04/30/bu...ss/30food.html

[TughEmotteTug]

China makes arrest in pet food case.

[wllsqyuipknczx]

The New York Times
May 1, 2007

U.S. Says Some Chicken Feed Tainted

By ALEXEI BARRIONUEVO

CHICAGO, April 30 — Government investigators said Monday that byproducts from pet food contaminated with wheat gluten imported from China were used in chicken feed on some farms in Indiana.

The latest revelation came as part of the investigation into imported rice protein concentrate and wheat gluten that have been found to contain melamine and melamine-related compounds. Pet food contaminated with melamine has killed at least 16 cats and dogs and sickened thousands of others.

The Agriculture Department and the Food and Drug Administration said that some 30 broiler poultry farms and eight breeder poultry farms in Indiana had received contaminated feed in early February and fed it to chickens within days of receiving it. All of those potentially affected chickens have since been processed.

The two agencies said they believed the likelihood of illness to people eating contaminated chicken was low because the contamination was most likely diluted. Without evidence of harm to humans, the agencies said they were not issuing recalls of any of the processed chicken products.

The Agriculture Department and the F.D.A. revealed last week that eight pork producers in seven states had purchased adulterated feed. Some 6,000 hogs were quarantined as a result in California, Kansas, North Carolina, New York, Oklahoma, South Carolina and Utah. Authorities are also in contact with a feed mill in Missouri that might have received adulterated products.

On Monday, Tyson Foods acknowledged that it had sent nearly 200 hogs that may have eaten feed containing melamine to a pork-processing plant. But the F.D.A. and the U.S.D.A. said they were not concerned that those hogs posed any risk to people, according to Bloomberg News.

Copyright 2007 The New York Times Company

http://www.nytimes.com/2007/05/01/business/01feed.html

[seekfrieddy]

From above ^^^ article:
The two agencies said they believed the likelihood of illness to people eating contaminated chicken was low because the contamination was most likely diluted. Without evidence of harm to humans, the agencies said they were not issuing recalls of any of the processed chicken products.

[brandiweb]

The New York Times
May 18, 2007

An Export Boom Suddenly Facing a Quality Crisis



Aly Song/Reuters
China exports $30 billion a year in agricultural and drug products to Asia, Europe and North America from ports like this one in Shanghai.
By DAVID BARBOZA

SHANGHAI, May 17 — Weeks after tainted Chinese pet food ingredients killed and sickened thousands of dogs and cats in the United States, this country is facing growing international pressure to prove that its food exports are safe to eat.

But simmering beneath the surface is a thornier problem that worries Chinese officials: how to assure the world that this is not a nation of counterfeits and that “Made in China” means well made.

Already, the contamination has produced one of the largest pet food recalls in American history, heightening global fears about the quality and safety of China’s agricultural products. And evidence has also shown that China exported fake drug ingredients, threatening to undermine the credibility of another booming export.

“This isn’t an international crisis yet, but if they don’t do something about it quickly, it will be,” said David Zweig, a China specialist who teaches at the Hong Kong University of Science and Technology. “The question is whether it spills over and ‘Made in China’ becomes known as ‘Buyer Beware.’ ”

With contamination known to have spread to feed for livestock and fish, some of America’s biggest food companies, like Kraft Foods, are lobbying the United States government to press China to improve its food safety measures.

Kraft, Kellogg and other food companies have said they are reviewing their food safety procedures and upgrading equipment. These executives worry that another scare involving China could set off a consumer backlash against Chinese or foreign imports and reverse a trend that has made large food makers increasingly dependent on processed ingredients from developing countries.

Experts also say doubts about the quality of China’s food shipments and worries about its fake drugs could affect other exports if buyers begin to find safety problems or other product flaws.

Indeed, the frequency of recalls of Chinese imports has risen in recent years, according to the Consumer Product Safety Commission.

For instance, two weeks ago, Wal-Mart Stores announced a nationwide recall of baby bibs made in China after some of those bibs tested positive for high levels of lead.

Just this week, the Cardinal Distributing Company recalled 300,000 children’s rings with dice or horseshoes, and Spandrel Sales and Marketing recalled about 200,000 necklaces, bracelets and rings. In both cases, the jewelry, which was made in China and sold in American vending machines, had high levels of lead.

Many consumers have also told pet food makers that they want goods that are free of any ingredients from China, according to the Pet Food Institute.

At stake for China is more than $30 billion a year in agricultural and drug exports to Asia, Europe and North America. For multinationals, not to mention the smaller American importers, the stakes are much higher.

The current scare may prompt changes in China. The former head of the nation’s food and drug safety watchdog is now on trial in Beijing, accused of accepting bribes and failing to curb the growing market in fake and dangerous medicines.

Still, few trade experts believe that China’s export boom is going to slow anytime soon. China’s shipments of vegetables and seafood have been soaring in recent years. And many importers say they would rather work with Chinese companies to raise safety levels than switch suppliers. China is also negotiating with the United States and the European Union to have them accept Chinese poultry products. That move is opposed by American and European poultry farmers, who are using the pet food scandal to press their case.

“If you bring chicken in here from China, you don’t know what that chicken ate, and I think that’s dangerous,” said Lucius Adkins, president of the United Poultry Growers Association.

Indeed, certain industries will face greater challenges, starting with feed processing, where two Chinese companies were found to have intentionally mixed an industrial chemical called melamine with wheat flour to heighten protein readings artificially.

Pharmaceuticals need to overcome even higher hurdles, particularly since last year when 100 people died in Panama after ingesting fake ingredients used in cough syrup.

“We’re now learning some of the dirty secrets behind this fast-growing economy,” said Wang Fei-ling, a professor of international affairs at the Georgia Institute of Technology. “And the dirty secret is they’re cutting corners in making things.”

In some places around the world, reaction has been swift. In Europe, food safety authorities are testing all Chinese protein imports for melamine. In South Korea, the CJ Corporation, one of the country’s largest food and feed makers, said last week that it was recalling 42 tons of wheat gluten from China even though the products had not tested positive for melamine.

“The major effect of this seems to me that the Chinese have been alerted that they should get their house in order,” says Dr. M. D. Merbis, an economist at the Center for World Food Studies in Amsterdam.

Some Chinese exports are feeling the pinch.

“A Spanish company came to visit us and was planning to buy our product,” said Sun Hong, chief executive of the Sanfu Biochemical Company, a rice protein maker in Hangzhou.

“We were going to strike a deal at the end of the month. But after what happened in the U.S. they haven’t even replied to our e-mail yet.”

Experts say that to restore confidence, China needs to confront the issue and not be seen as covering up or delaying the release of information, which seemed to be the case during recent outbreaks of severe acute respiratory syndrome, or SARS, and bird flu.

In similar fashion, after the initial news about melamine came out, China denied having shipped any wheat gluten to the United States and one official said melamine could not have harmed pets.

Only after an international storm surrounded the case in mid-April, and Senator Dick Durbin, Democrat of Illinois, publicly rebuked China for its response to the investigation did China fully cooperate with American regulators.

Now, in a turnabout, China has banned melamine from food and feed proteins and announced nationwide inspections.

“You have to realize,” said Professor Wenran Jiang at the University of Alberta, “China is going through a radical transformation and it’s hard to manage. The state just doesn’t have the expertise to keep up with these things.”

The problems here are compounded by strict controls over the media that keep the public in the dark about food and drug safety violations, experts say.

Most Chinese are still unaware of the pet food scandal in the United States because the story has largely been ignored by the Chinese news media. Several Chinese editors contacted in recent weeks said they were ordered by the government propaganda department not to report on the case.

“This has been a key,” says Steve Tsang, who teaches at Oxford. “The government has the ability to censor and manage the flow of the news.”
Hoping to investigate why melamine contaminated so much pet food, investigators from the Food and Drug Administration spent two weeks in

China this month. They said the Chinese government was cooperative.

But last week F.D.A. officials acknowledged that agency investigators had no opportunity to carry out their own work here. The Chinese government had already done it.

“We visited the two facilities but there’s essentially nothing to be found in that they are currently closed down, not operating,” Walter Batts, an F.D.A. official, said during a recent news conference.

United States investigators were not allowed to interview the managers of the Chinese pet feed companies accused of violations, even though they were being held in detention centers.

After United States investigators left, China issued a statement asking the United States not to punish other exporters of food ingredients for the misdeeds of a few rogue companies, and not to let this become a trade quarrel.

Experts say China would like to close the door on the episode. And so would America’s biggest food companies like Kraft, which is supporting an organization that is pushing to strengthen the F.D.A.

In a statement issued this week, Kraft Foods said, “We’re also lending our support to the Coalition for a Stronger F.D.A. and industry colleagues in urging Congress for substantial funding increases to the F.D.A. for the agency’s food oversight functions.”

But many experts say the real challenge lies in China — in ensuring that its aggressive entrepreneurs are tamed and that its inspectors can better monitor the contents of exports now valued at more than $1 trillion a year.

If they cannot, some analysts say there could be a shift in consumer attitudes toward products “Made in China.”

“This kind of thing is like leaves settling on the forest floor,” said Robert A. Kapp, a longtime China specialist and former president of the U.S.-China Business Council. “They gradually accumulate and change one’s impression over time.”

F.D.A. Says Fish Are Untainted Farmed fish that may have eaten food with imported Chinese ingredients show no traces of contamination and should be safe to eat, the Food and Drug Administration said yesterday.

The two fish farms that used the feed kept their fish off the market until the tests could be completed.

Dr. David W. K. Acheson, assistant commissioner for food protection, said fish being raised at Kona Blue in Hawaii and American Gold Seafoods in Washington State tested negative for the chemical melamine.

The questionable feed was also sold to 196 fish hatcheries. Because those fish are small and the feed has been recalled, Dr. Acheson said the F.D.A. believed that there was no longer any public health concern.

On Tuesday, the F.D.A. cleared for market 56,000 pigs given feed that included scraps of pet food contaminated with melamine.

Copyright 2007 The New York Times Company

http://www.nytimes.com/2007/05/18/bu...s/18trade.html

[Kayacterype]

The New York Times
June 17, 2007

F.D.A. Tracked Tainted Drugs, but Trail Went Cold in China

By WALT BOGDANICH

After a drug ingredient from China killed dozens of Haitian children a decade ago, a senior American health official sent a cable to her investigators: find out who made the poisonous ingredient and why a state-owned company in China exported it as safe, pharmaceutical-grade glycerin.

The Chinese were of little help. Requests to find the manufacturer were ignored. Business records were withheld or destroyed.

The Americans had reason for alarm. “The U.S. imports a lot of Chinese glycerin and it is used in ingested products such as toothpaste,” Mary K. Pendergast, then deputy commissioner for the Food and Drug Administration, wrote on Oct. 27, 1997. Learning how diethylene glycol, a syrupy poison used in some antifreeze, ended up in Haitian fever medicine might “prevent this tragedy from happening again,” she wrote.

The F.D.A.’s mission ultimately failed. By the time an F.D.A. agent visited the suspected manufacturer, the plant was shut down and Chinese companies said they bore no responsibility for the mass poisoning.

Ten years later it happened again, this time in Panama. Chinese-made diethylene glycol, masquerading as its more expensive chemical cousin glycerin, was mixed into medicine, killing at least 100 people there last year. And recently, Chinese toothpaste containing diethylene glycol was found in the United States and seven other countries, prompting tens of thousands of tubes to be recalled.

The F.D.A.’s efforts to investigate the Haiti poisonings, documented in internal F.D.A. memorandums obtained by The New York Times, demonstrate not only the intransigence of Chinese officials, but also the same regulatory failings that allowed a virtually identical poisoning to occur 10 years later. The cases further illustrate what happens when nations fail to police the global pipeline of pharmaceutical ingredients.

In Haiti and Panama, the poison was traced to Chinese chemical companies not certified to make pharmaceutical ingredients. State-owned exporters then shipped the toxic syrup to European traders, who resold it without identifying the previous owner — an attempt to keep buyers from bypassing them on future orders.

As a result, most of the buyers did not know that the ingredient came from China, known for producing counterfeit products, nor did they show much interest in finding out.

China itself was a victim of diethylene glycol poisoning last year when at least 18 people died after ingesting poisonous medicine made there. In the wake of the deaths, and reports of pet food and other products contaminated with dangerous ingredients from China, officials there announced that they would overhaul the regulation of food, drugs and chemicals.

Beyond the three incidents linked to Chinese diethylene glycol, there have been at least five other mass poisonings involving the mislabeled chemical in the past two decades — in Bangladesh, Nigeria, Argentina and twice in India.

“This problem keeps coming back,” said Dr. Joshua G. Schier, a toxicologist with the Centers for Disease Control and Prevention. And no wonder: the counterfeiters are rarely identified, much less prosecuted.

Finding a way to keep diethylene glycol out of medicine, particularly in developing countries, has confounded health officials for decades. “It is preventable and we have to figure out some way of stopping this from happening again,” said Carol Rubin, a senior C.D.C. official.

In a global economy, ingredients for drugs are often bought and sold many times in different countries, sometimes without proper paperwork, all of which increases the risk of fraud, the authorities say.

The Panama poison passed through five hands, the Haitian poison six. In both cases, the factory’s original certificate of analysis, attesting to the contents of the shipment and its provenance, did not accompany the product as it moved around the world.

“Where there is a loophole in the system, a frailty in the system, it’s the ability of an unscrupulous distributor to take industrial or technical material and pass it off as pharmaceutical grade,” said Kevin J. McGlue, a board member of the International Pharmaceutical Excipients Council.

Uncovering that deception can be difficult. “It’s impossible to get anyone to do the trace-backs,” said Dr. Michael L. Bennish, co-author of a 1995 medical journal article on a poisoning epidemic in Bangladesh.

One reason, Dr. Bennish said, is the clout of local manufacturers. “We tried to follow up as amateur Sherlocks, investigators, but you don’t go down to the wholesale market and ask questions,” he said. “You are going to get your fingers burnt.”

A Crisis in Haiti

By the end of June 1996, the F.D.A. knew it might have an international crisis on its hands. A poison had found its way into fever syrup in Haiti, and the F.D.A. wanted to know if more of the same might be heading to the United States or, for that matter, to any other country. But to learn that, the agency needed to find the manufacturer.

This was not just any poison. Virtually every young poisoning victim who showed up at the main hospital in Port-au-Prince, Haiti’s capital, died.

Labeled pharmaceutical-grade glycerin, the toxic syrup was mixed into thousands of bottles of fever medicine. For months, parents gave it to children, then watched them die, in agony, from kidney failure. No one suspected the medicine until much later.

Officially, at least 88 children died, nearly half under the age of 2. But those 88 were only the ones doctors remembered or for whom hospital records could be found.

The F.D.A. traced the poison to a German broker, Chemical Trading and Consulting, but the company’s records were not much help. “They cannot trace glycerine lots to their manufacturer,” David Pulham, an F.D.A. investigator, wrote on June 30, 1996.

Chemical Trading had arranged for a Dutch company, Vos B.V., to sell 72 barrels of the suspect syrup to Haiti, records show. The agency dispatched an investigator, Ann deMarco, who made an unsettling discovery: sitting in Vos’s warehouse near Rotterdam were 66 more barrels labeled glycerin, all containing lethal concentrations of diethylene glycol.

“Some of this second shipment has been sold,” Ms. deMarco wrote in a memorandum on July 4, 1996. Although the missing barrels had gone to an industrial user, not a drug maker, the F.D.A.’s worries grew.

Ms. deMarco learned that another broker, Metall-Chemie, a German trader, had arranged for Vos to buy the barrels from Sinochem International Chemicals Company, a giant exporter in Beijing owned by the Chinese government.

But Metall-Chemie also did not know the manufacturer, and one of its officials predicted that the F.D.A. would have trouble finding that out. “It is difficult to get any information from Chinese traders,” Ms. deMarco wrote.

More complete shipping records would have identified who made the poison. But in this case, records provided few clues.

“The original source of the material had been obliterated on documents and product containers,” Ms. deMarco wrote to senior F.D.A. officials.

“One trader referred to this practice as ‘neutralization.’ I was advised that neutralization is a common practice among traders in order to protect their business interests.”

With no paper trail, American officials turned to Sinochem for help.
Initially, they took an indirect approach. In July 1996, the American Embassy in China contacted the company and asked for a list of Chinese glycerin makers, without saying that it was investigating the Haiti poisonings. Sinochem, however, “would not reveal the names of actual manufacturers in order to prevent the prospective foreign customer from bypassing Sinochem,” an embassy official reported to Washington.

In early August, American officials asked Sinochem representatives specifically about the origin of the Haiti poison. “They want to investigate further and were unable (or unwilling) to give the name of the manufacturer at this time,” the officials reported.

Federal investigators sought help from senior Chinese drug regulators, who promised to help find the manufacturer, but said it “will take time,” records show.

When another month passed without any word from either regulators or Sinochem, the embassy tried again. Chinese regulators said they had done nothing to find the factory, according to a confidential State Department telegram from September 1996.

Sinochem did finally offer the manufacturer’s name: the Tianhong Fine Chemicals Factory in the city of Dalian in northeastern China. But Sinochem “refused” to provide an address, saying it was illegible. A telephone number would have to suffice, it said.

That, too, was unproductive. When American investigators called the plant manager, Zhang Gang, they were told he was not available. Send a fax, they were told. That did not work either. “The phone was always busy,” investigators reported.

Finally, they got Mr. Zhang on the phone, but he, too, refused to give out his factory’s address. He said that tests had found no signs of diethylene glycol, adding that “there had been no cases in China of poisoning resulting from the ingestion” of glycerin contaminated by diethylene glycol, investigators wrote.

After months of trying to trace the poison to its source, United States investigators were at a dead end.

“The Chinese officials we contacted on this matter were all reluctant to become involved,” a State Department official wrote in late September 1996, saying that drug regulators and the plant manager had insisted on communicating only on the telephone “to avoid leaving a paper trail.”

He added, “We cannot be optimistic about our chances for success in tracking down the other possible glycerine shipments.”

The following May, Mr. Pulham, who was part of the original F.D.A. investigative team in Haiti, tried to revive the investigation. “Is it possible to block-list all Chinese pharmaceutical products until we gain cooperation?” he asked.

The suggestion went nowhere. Five months later, Ms. Pendergast of the F.D.A. wrote her memorandum, imploring investigators to keep digging.
“China is turning into one of the major bulk pharmaceutical producers in the world,” she wrote. “Unless they have an open, transparent and predictable system for dealing with problems and other countries, it is going to be rough sledding in the years ahead.”

On Nov. 17, 1997, federal investigators once again questioned Sinochem officials. They denied any wrongdoing, saying that two certificates of analysis showed that the suspect shipment was safe, pharmaceutical-grade syrup. But when the F.D.A. asked to see them, Sinochem refused.

“The officials were not willing to explain why they could not provide the copies,” an American official reported at the time.

Chen Liusuo, who handled the glycerin sales, strongly disputed the F.D.A.’s account. In an interview with The Times, Mr. Chen said Sinochem cooperated. “We gave them everything they wanted,” Mr. Chen said, adding that the agency was satisfied.

“The product we sold was glycerin,” he said. “It passed through three or four companies after us. To find the problem you need to look at every link in the supply chain.”

A Chinese government official familiar with the F.D.A.’s inquiries said the Americans’ frustration might have stemmed from their misunderstanding about who regulated chemical companies, which led them to seek help from the wrong officials. “This was a truly tragic event, and we expressed our sadness and sympathy,” said the official, who asked not to be identified.

At the end of 1997, a year and a half after the F.D.A. began tracing the poisonous shipments, one of its investigators, Ted Sze, finally got inside the Tianhong chemical plant in Dalian. But glycerin was no longer made there, and Mr. Sze had no records to inspect. The plant manager, Mr. Zhang, told investigators that he had received no complaints about his products and that his company had not produced the poison.

Mr. Sze, now retired from the F.D.A., said in an interview that he had no choice but to accept the manager’s word and clear the company of wrongdoing. “By the time I went there, the plant was already shut down,” he said. “The agency can only do so much.”

The Experts’ Recommendations

The United States may not have gotten what it wanted from China, but the Haiti crisis did bring together health groups to search for ways to stop diethylene glycol poisonings. At a workshop in Washington in February 1997, health experts recommended that certificates of analysis be improved to allow users to “trace the product back through every intermediary, broker and repackager to the original manufacturer.”

The workshop participants also called for better testing of drug ingredients and asked governments to tighten oversight of drug manufacturing.

The next year, the World Health Organization offered many of the same recommendations. And a 1998 article in JAMA, the Journal of the American Medical Association, warned that failure to strictly follow the guidelines could cause poisonings “even in countries where quality control procedures are usually strictly applied.”

Much of this had been said before, yet the poisonings have continued.
Just as the JAMA article was being published, three dozen children began dying of acute renal failure at two hospitals in Delhi, India. A local drug maker had unwittingly mixed diethylene glycol into acetaminophen syrup, much as the Haitian pharmacist had.

The drug maker was prosecuted, but according to interviews and government records no progress had been made in identifying the supplier of the poison.

“My experience as an investigator tells me that many of these things will not be proven,” said Dr. M. Venkateswarlu, the drug controller general of India.

Finding counterfeiters often means pursuing leads across foreign borders, and no international authority has the power to do that. Dr. Howard Zucker, who helps to oversee drug issues for the W.H.O., said individual countries must conduct their own trace-back investigations.

But if the United States could not do that on behalf of Haiti, poorer, less influential nations would have little chance of tracking down counterfeiters.

After the Haiti poisoning, a more accurate, less expensive test for diethylene glycol was developed, but last year’s case in Panama shows that suppliers and governments do not always use it.

And as long as counterfeiters do not fear prosecution, the poisonings are likely to continue, experts say.

Dr. Mohammed Hanif, a prominent physician in Dhaka, Bangladesh, said the foreign suppliers of diethylene glycol were never prosecuted for the deaths of thousands of children from 1982 to 1992. “The traumatizing memories of those days still torment me,” said Dr. Hanif, who wrote a paper about the deaths from toxic medicine.

In Argentina, a court official said no one had been prosecuted for supplying the diethylene glycol that ended up in a health supplement, killing 29 people in 1992.

David Mishael, a Miami lawyer, knows the difficulty of assigning blame in these deaths. For 10 years, Mr. Mishael has unsuccessfully pursued legal claims in the United States and Europe against European traders that helped to arrange the shipment of toxic syrup to Haiti. “You can imagine the cost,” said Mr. Mishael, who is representing Haitian parents whose children died from the fever medicine.

He said Dutch authorities assessed a $250,000 fine against Vos, which tested the counterfeit syrup, found it impure and did not alert anyone in Haiti. But given how many died, he called the size of the fine “a joke.” A lawyer who represents Vos, Jeffrey B. Shapiro, declined to comment.

A few children survived after being flown to the United States by humanitarian groups. One of them, Faika Jean, was 2 months old at the time and nearly died en route. Now 11, she has learning disabilities as a result of the poisoning, said her father, Wislin Jean.

Ms. Pendergast, now a private lawyer and consultant, said China had the most to answer for. “Everybody else is just reacting to initial failures,” she said. “It needs to take steps to protect not just its own consumers but also consumers all around the world.”

After The Times reported in May that the Panama poison had been made and exported by Chinese companies as 99.5 percent pure glycerin, Chinese regulators said they would reopen their investigation of the incident. Three weeks later, the officials acknowledged some “misconduct” in how Chinese companies labeled the toxic syrup.

But most of the blame, they said, rested with a Panamanian importer who changed the paperwork to make the syrup look safer than it actually was.
The F.D.A. disagrees, saying the deception began with Chinese companies falsely labeling a poisonous product glycerin. “If the drums had been 99.5 percent glycerin, the deaths in Panama would never have occurred,” the F.D.A. said in a statement.

A Dissatisfied Customer

The F.D.A.’s Haiti investigation never did find more counterfeit glycerin from China, despite a global hunt. But its concerns, it turns out, were not unfounded.

In 1995, the same year babies began to die in Haiti, 284 barrels of a chemical labeled glycerin arrived in New York on container ships. Although the chemical was not intended for use in drugs, it was labeled 98 percent pure. An official with the company that bought the barrels, Dastech International, of Great Neck, N.Y., would later say, “It smelled like glycerin, it looked like glycerin.” But after one of its customers complained, Dastech took a closer look.

Although the chemical was labeled 98 percent pure glycerin, Dastech said in court records that the syrup actually contained sugar compounds — as well as diethylene glycol.

The exporter was Sinochem. Claiming that it was fleeced, Dastech tried to get its money back from the broker who arranged the sale, court records show.

It never did.

Reporting was contributed by Jake Hooker from Beijing, Hari Kumar from New Delhi, Anand Giridharadas from Mumbai, and Julfikar Ali Manik from Dhaka, Bangladesh.

Copyright 2007 The New York Times Company

http://www.nytimes.com/2007/06/17/health/17poison.html

[fkisjjdhh]

Mwahahaa...pretty soon we'll all be eating organic food from China that will actually be grown on the polluted lands without fertilizer

[pKgGpUlF]

Eugenious, I'm so glad that you post here - otherwise I might be posting to myself. Also, you're funny.


China protests US halt to China seafood

By ALEXA OLESEN, Associated Press Writer
June 29, 2007

A key Chinese official criticized a U.S. block on its seafood as `'indiscriminate," and urged closer cooperation on food safety between the two trading partners, state media said Saturday.

"China cannot accept the indiscriminate and automatic detention of four kinds of Chinese seafood by the United States" Li Changjiang, the head of China's top quality watchdog, was quoted as saying.

Li made his comments late Friday during a telephone conversation with U.S. Health and Human Services Secretary Michael Leavitt, the official Xinhua News Agency reported.

The U.S. Food and Drug Administration announced Thursday it would detain three types of fish — catfish, basa and dace — as well as shrimp and eel after repeated testing turned up contamination with drugs unapproved in the United States for use in farmed seafood.

U.S. officials said there have been no reports of illnesses nor do the products pose any immediate health risk. They stopped short of ordering a ban on the fresh and frozen seafood.**

The action comes amid a slew of consumer alerts by U.S. federal regulators over lead paint in Chinese-made toy trains, defective tires from the eastern city of Hangzhou, and imported Chinese toothpaste made with diethylene glycol, a toxic ingredient more commonly found in antifreeze.

The safety scandals have put at risk surging Chinese agricultural exports to the United States, which reached $2.26 billion last year, led by poultry products, sausage casings, shellfish, spices and apple juice.

Li, the head of China's General Administration of Quality Supervision, Inspection and Quarantine, said there were a "handful of Chinese seafood enterprises" that had problems with quality control but that this did not warrant a blanket detention on all Chinese exporters of those types of seafood, Xinhua reported.

He told Leavitt some U.S. exports to China also had quality issues and that the two sides should properly resolve such problems by cooperating more closely.

Earlier this week, China announced it had seized shipments of U.S.-made orange pulp and dried apricots containing high levels of bacteria and preservatives.

Leavitt was quoted as saying the U.S. would send a team to China soon to negotiate a solution to the seafood ban.

The FDA said sampling of Chinese imported fish between October and May repeatedly found traces of the antibiotics nitrofuran and fluoroquinolone, as well as the antifungals malachite green and gentian violet. The FDA will allow individual shipments of the five seafood species into the country if a company can show the products are free of residues of these drugs.

Copyright © 2007 The Associated Press. All rights reserved.

http://news.yahoo.com/s/ap/20070630/...inted_products


**Note to self: It may not be banned, but don't buy it.

[FliveGell]

The New York Times
July 13, 2007

Tougher Safety Rules Are Prepared for Imports


Ryan Pyle for The New York Times
A worker packaging toy trains for
export at the Li Cheng Industrial Park
in Dong Guan, China.

By ERIC LIPTON

WASHINGTON, July 12 — Responding to the outcry over dangerous imports from China and other unsafe products, the head of the Consumer Product Safety Commission is preparing regulatory proposals that could mandate broader inspections of imports and stiffer penalties for ignoring safety rules.

Consumer safety advocates welcomed the proposals Thursday as a departure for the agency, which has been criticized repeatedly during the Bush administration as being reluctant or slow to approve new product safety mandates.

Agency officials said the initiatives were inspired by the surge in problematic imports from China and reports of dangers associated with other products, including all-terrain vehicles, as well as efforts by Democrats in Congress to take up their own regulatory changes.

“It ends up being the perfect storm,” said Julie Vallese, an agency spokeswoman.

The new rules are, however, far from imminent. They would require approval by Congress and enforcement by the commission, which since January has been unable to take votes because it lacks a quorum. Industry officials have already expressed opposition to some of the ideas.

Nancy A. Nord, a Republican appointed by President Bush who is the commission’s acting chairwoman, is drafting the proposed changes. Ms. Nord’s staff has recently provided briefings to major United States importers and manufacturers as well as consumer advocates.

White House officials have also been briefed, members of her staff said. It is unclear whether the White House, which has generally favored loosening regulations on businesses, will formally endorse the plan.

Under her plan, importers and manufacturers would have to certify that products comply with regulatory standards, which might mean more inspections before goods are sent to the United States or placed on store shelves. Such an inspection might have detected the lead paint in Thomas & Friends wooden train toys made in China, which were recently recalled.

The commission might also decide to enforce certain voluntary industry standards for items, including cigarette lighters and all-terrain vehicles, both of which have been connected to consumer injuries and deaths.

That would give the agency the power to seize products or block their entry to the country. Now, the agency must sometimes wait until products are on the market and then push for a recall.

Discount retailers and Internet-based companies, among others, would also be explicitly prohibited from selling products that have been the subject of a recall.

Ms. Nord is also considering supporting an increase in the maximum fine the commission can impose, to as much as $10 million from about $2 million, said the commission’s chief of staff, Quin D. Dodd. A separate proposal already before Congress would allow fines of up to $20 million.

The list of specific changes Ms. Nord will propose is still incomplete and subject to revision, Mr. Dodd said. Thomas Moore, a Democrat who is the only other current member of the commission, is preparing his own list of proposed regulatory changes, the details of which have not been disclosed.

Charles A. Samuels, a lawyer in Washington who represents the nation’s major appliance manufactures, said that although he supported the effort, he was concerned that some of the measures might disrupt trade.

“There is some public crisis of confidence with some of the products coming into the U.S.,” Mr. Samuels said. “But if all of a sudden you are into some kind of a Russian-styled bureaucracy involving product certification that is not going to help at all.”

Frederick B. Locker, a New York lawyer who represents the nation’s largest importers and manufacturers of toys and nursery products, said a top fine of $10 million would be excessive.

“Most of American businesses are small businesses — and most small businesses cannot handle a fine of that magnitude,” Mr. Locker said.
Consumer advocates reacted with cautious praise, saying they want to know more about the proposals.

“The devil is in the details,” said Alan Korn, general counsel for Safe Kids Worldwide, a group based in Washington, which was briefed by Mr. Dodd on the plan. “But it sounds like you are trying here. There is an attempt here.”

Sally Greenberg, senior product safety counsel for Consumers Union, which publishes Consumer Reports, said the changes should include the repeal of a provision that prohibits the release of information about certain products, including injuries or deaths, before consulting with the manufacturer, a requirement that often means such reports are never released.

The regulatory proposals are being developed after months of strong criticism of the commission. For example, it was accused of moving slowly to recall magnetic toys that severely injured several children and killed one child who accidentally swallowed small magnets. Critics have also said the commission was reluctant to ban the sale of adult all-terrain vehicles for use by children.

Representative Bobby L. Rush, Democrat of Illinois and chairman of the House subcommittee that oversees the commission, said on Thursday that he looked forward to seeing the proposals.

“Right now, the agency is a distant sixth cousin to the federal government or a stepchild,” Mr. Rush said. “The American public needs to know that wherever products are imported from, in any part of the world, there is a standard of safety that is met.”

Copyright 2007 The New York Times Company
http://www.nytimes.com/2007/07/13/wa...er.html?ref=us