Chinese protein export contamination
Encyclopedia
Protein adulteration in the People's Republic of China refers to the adulteration and contamination of several food and feed ingredients with inexpensive melamine
and other compounds such as cyanuric acid
, ammeline
and ammelide
. These adulterants can be used to inflate the apparent protein content of products, so that inexpensive ingredients can pass for more expensive, concentrated proteins. Melamine by itself has not been thought to be very toxic to animals or humans except possibly in very high concentrations, but the combination of melamine and cyanuric acid has been implicated in kidney failure. Reports that cyanuric acid may be an independently and potentially widely-used adulterant
in China have heightened concerns for both animal and human health.
Chinese protein export contamination was first identified after the wide recall
of many brands of cat and dog food
starting in March 2007 (the 2007 pet food recalls
). The recalls in North America
, Europe and South Africa
came in response to reports of kidney failure in pets. Several Chinese companies sold products claimed to be wheat gluten
, rice
protein or corn
gluten, but which proved to be wheat flour
adulterated with melamine
, cyanuric acid
, and other contaminants. The Chinese government
was slow to respond, denying that vegetable protein was exported from China and refusing to allow foreign food safety investigators to enter the country. Ultimately, the Chinese government acknowledged that contamination had occurred and arrested the managers of two protein manufacturers identified so far and took other measures to improve food safety and product quality.
Reports of widespread adulteration of Chinese animal feed with melamine have raised the issue of melamine contamination in the human food supply both in China and abroad. On 27 April 2007, the U.S. Food and Drug Administration (FDA) subjected all vegetable proteins imported from China, intended for human or animal consumption, to detention without physical examination, including: Wheat Gluten, Rice Gluten, Rice Protein, Rice Protein Concentrate, Corn Gluten, Corn Gluten Meal, Corn By-Products, Soy Protein, Soy Gluten, Proteins (includes amino acids and protein hydrosylates), and Mung Bean Protein. In a teleconference with reporters on 1 May, officials from the FDA and U.S. Department of Agriculture said that between 2.5 and 3 million people in the United States had consumed chickens that had consumed feed containing contaminated vegetable protein from China. Reports that melamine has been added as a binder in animal feed manufactured in North America also raise the possibility that harmful melamine contamination might not be limited to China.
In September 2008, Sanlu Group
had to recall baby formula
because it was contaminated with melamine. Around 294,000 babies in
China became ill after drinking the milk; at least six babies died.
As of July 2010, Chinese authorities were still reporting some seizures of melamine-contaminated dairy product in some provinces, though it was unclear whether these new contaminations constituted wholly new adulterations or were the result of illegal reuse of material from the 2008 adulterations.
The first recalls were announced by Menu Foods late on Friday, 16 March 2007 for cat and dog food products in the United States. By 30 March the United States began to ban imports of wheat gluten from China. The Chinese government responded on 4 April by categorically denying any connection to the North American food poisonings refusing to allow inspection of facilities suspected of producing contaminated products.
However, on 6 April 2007, the Chinese government told the Associated Press
they would investigate the source of the wheat gluten and by 23 April China gave permission to FDA investigators to enter the country. On 25 April Chinese authorities began to shut down and destroy the implicated factories and detain their managers. The following day, China's Foreign Ministry said it had banned the use of melamine in food products, admitting that products containing melamine had cleared customs while continuing to dispute the role of melamine in causing pet deaths.
China also vowed to cooperate with U.S. investigators to find the "real cause" of pet deaths.
The United States Senate
held an oversight hearing on the matter by 12 April. The economic impact on the pet food market has been extensive, with Menu Foods losing roughly $
30 million alone from the recall.
On 24 April 2007, for the first time FDA officials said that melamine had been detected in feed given to animals raised for human consumption within the United States.
As of 7 May 2007, United States food safety officials stated: "There is very low risk to human health from consuming meat from hogs and chickens known to have been fed animal feed supplemented with pet food scraps that contained melamine and melamine-related compounds"
to fish feed manufactured in the United States from ingredients produced in Ohio. This adulteration has not been linked to any illness. The FDA issued a Warning Letter
to Tembec, the manufacturer of the adulterated binding ingredients. In response, Tembec declared that, in addition to completing the recall of all products containing the adulterated binding ingredients, it would "discontinue manufacturing and marketing of
[the products] as aquatic feed binder. Tembec's aquatic feed binder products were also used by another US company, Uniscope, to produce a binder (XtraBond) for livestock feeds. This binder and the feeds made from it were not recalled, nor was the meat of the livestock fed on these feeds. No fish or fish products were recalled as a result of having been raised on the adulterated feeds.
In 2008, investigation of kidney problems in Chinese infants focused on domestic dairy suppliers in China.
, mainly by either catalyzed
gas-phase
production or high pressure
liquid-phase
production, and is soluble in water. Melamine is used combined with formaldehyde
to produce melamine resin
, a very durable thermosetting plastic
, and melamine foam, a polymer
ic cleaning product. The end products include counter-tops, fabrics, glue
s and flame retardant
s. Occasionally, melamine-formaldehyde resin is added to gluten for non-food purposes, such as adhesives or fabric printing.
Melamine is also a byproduct of several pesticide
s, including cyromazine
. The Food Safety and Inspection Service
(FSIS) of the United States Department of Agriculture
(USDA) provides a test method for analyzing cyromazine and melamine in animal tissues in its Chemistry Laboratory Guidebook which "contains test methods used by FSIS Laboratories to support the Agency's inspection program, ensuring that meat, poultry, and egg products are safe, wholesome and accurately labeled." In 1999, in a proposed rule published in the Federal Register
regarding cyromazine residue, the United States Environmental Protection Agency
(EPA) proposed "remov[ing] melamine, a metabolite
of cyromazine from the tolerance expression since it is no longer considered a residue of concern."
Melamine production in China has also been reported as using coal
as raw material. This production has been described as also producing "melamine scrap" which is not "pure melamine but impure melamine scrap that is sold more cheaply as the waste product after melamine is produced by chemical and fertilizer factories here." Shandong Mingshui Great Chemical Group, the company reported by the New York Times as producing melamine from coal
, produces and sells both urea
and melamine
but does not list melamine resin
as a product. Melamine production in China has increased greatly in recent years and was described as in "serious surplus" in 2006 . In the United States Geological Survey
2004 Minerals Survey Yearbook, in a report on worldwide nitrogen
production, the author stated that "China continued to plan and construct new ammonia and urea plants using coal gasification
technology."
The off-gas in production contains large amounts of ammonia (see melamine synthesis). Therefore melamine production is often integrated into urea production which uses ammonia as feedstock. Crystallization and washing of melamine generates a considerable amount of waste water, which is a pollutant if discharged directly into the environment. The waste water may be concentrated into a solid (1.5-5% of the weight) for easier disposal. The solid may contain approximately
70% melamine, 23% oxytriazines (ammeline
, ammelide
and cyanuric acid
), 0.7% polycondensates (melem
, melam
and melon).
In January 2009, China's Ministry of Industry and Information Technology promulgated draft production permit rules aiming to stem a melamine production glut. Melamine had been widely sold, including over the Internet, for around 10,000 yuan ($1,500) a metric tonne. The ministry also aimed to shrink the number of melamine producers by setting minimum production levels and strengthening controls on ingredients and waste.
Some analysis methods for determining protein content actually measure the amount of nitrogen present, on the assumption that only protein in the sample contributes significantly to its nitrogen content. Melamine contains a very high proportion of nitrogen. According to Liu Laiting, a Chinese professor of animal sciences, melamine is also hard to detect in ordinary tests.
, Jiangsu, China, which U.S. officials believe was the source of the melamine-contaminated gluten, are maintaining innocence and assert that they are cooperating with officials. The general manager for Xuzhou Anying has denied that his company exported goods and says that they are researching who might have exported their product. They note that per Chinese law, all exported wheat gluten is tested and that they were simply a middle man
for local producers. However, a truck driver who has carried goods for Xuzhou Anying contradicted this, saying "they have a factory that makes wheat gluten." Officials in the USDA and FDA believe that Xuzhou Anying labeled its wheat gluten as "nonfood" and exported through a third party, Suzhou Textiles Silk Light & Industrial Products. The nonfood designation would allow the gluten to be shipped without inspection, however a spokesman for Suzhou Textiles has denied that the company exported any wheat gluten.
There is evidence that Xuzhou Anying, despite being a food ingredient supplier, has sought out large quantities of melamine in the past. The New York Times
has reported that as recently as 29 March 2007, representatives of Xuzhou Anying wrote, "Our company buys large quantities of melamine scrap" on a message board for the trading of industrial materials. Melamine may have been added to enhance the apparent protein content of the wheat gluten. However, the importer of the wheat gluten, ChemNutra
, claims that they received from Xuzhou Anying results of analyses showing "no impurities or contamination." It has not yet been determined whether Xuzhou Anying products other than wheat gluten have been shipped to North America.
The second Chinese supplier involved in shipping melamine-contaminated food ingredients, Binzhou Futian Biology Technology, has been working with importer Wilbur-Ellis since July 2006 . Binzhou Futian supplies soy, corn and other proteins to the United States, Europe and Southeast Asia. Binzhou typically ships rice protein concentrate in white bags but on 11 April one bag was pink and had the word "melamine" stenciled on it. Binzhou explained to Wilbur-Ellis that the original bag had broken and a mislabeled, but new, bag had been used. The company only supplies food and feed ingredients.
Stephen Sundlof, director of the FDA's Center for Veterinary Medicine, said that melamine turning up in exported Chinese wheat gluten, rice protein concentrate and corn gluten supports theories of intentional adulteration. "That will be one of the theories we will pursue when we get into the plants in China."
On 29 April 2007 and 30 April 2007, the International Herald Tribune
and New York Times reported that some animal feed manufacturers in China admit to having used melamine scrap in animal feed for years. Said Ji Denghui, general manager of the Fujian Sanming Dinghui Chemical Company: “Many companies buy melamine scrap to make animal feed, such as fish feed. 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.” Such use of "melamine scrap", described as leftover from processing of coal into melamine for use in creating plastic and fertilizer, was described as widespread. Melamine is said to have been chosen in order to inflate crude protein content measures and to avoid tests for other common and illegal ingredients, such as urea
.
As of 2 May 2007, officials of the USDA and FDA still do not know who manufactured the contaminated food or where the contamination took place. The Chinese government has said that Xuzhou Anying, for instance, purchased its products from 25 different manufacturers.
On 8 May 2007, The International Herald Tribune
reported that three Chinese chemical makers have said that animal feed producers often purchase, or seek to purchase, the chemical, cyanuric acid, from their factories to blend into animal feed to give the false appearance of a higher level of protein, suggesting another potentially dangerous way that melamine and cyanuric acid might combine in protein products.
The same day, FDA officials revealed that the vegetable proteins were not only contaminated, but mislabeled. Both the wheat gluten and rice protein concentrate were actually wheat flour, a much cheaper product from which wheat gluten is extracted. The addition of nitrogen-rich compounds were necessary to make the flour test as if it were protein extract.
found in China led to recall of Baby Formula products in China. Some Chinese reports said the manufacturer of the milk products might not have consciously added Melamine to their milk powder, however they could have used a soy protein substitute to lower production costs, and the source of their soy substitute had melamine added to it. Many Chinese babies had developed kidney stones and other acute kidney problems in recent months across China, investigation led to the discovery of this contaminant. Some people were wondering how much melamine has already entered food products designated for adults without discovery. More worrying are claims reported in China that there are now new chemicals that can be added to food to lower production costs, and yet pass the tests for melamine and other related chemicals. Impact of this incident to dairy industry outside China is beginning to unravel.
By the end of September 2008, the Chinese government said that 22 dairy companies, including Sanlu and export brands like Mengniu and Yili, had produced powdered baby formula that contained traces of melamine. Some dairy farmers interviewed in Hebei Province said it was an open secret that milk was adulterated. Some dairies routinely watered down milk to increase profits, then added other cheap ingredients so the milk could pass a protein test. "Before melamine, the dealers added rice porridge or starch into the milk to artificially boost the protein count, but that method was easily tested as fake, so they switched to melamine,” said Zhao Huibin, a dairy farmer near Shijiazhuang.
Investigators say the adulteration was nothing short of a wholesale re-engineering of milk. Researchers established that workers at Sanlu and at a number of milk-collection depots were diluting milk with water; they added melamine to dupe a test for determining crude protein content. "Adulteration used to be simple. What they did was very high-tech," says Chen Junshi, co-chair of the Sino-U.S. workshop and a risk-assessment specialist at China's Center for Disease Control and Prevention. Investigators subsequently learned that the emulsifier used to suspend melamine also boosted apparent milk-fat content. Sanlu baby formula contained a whopping 2563 mg/kg of melamine, adding 1% of apparent crude protein content to the formula, where normal milk is 3.0% to 3.4% protein. Chen says a dean of a school of food science told him that it would take a university team 3 months to develop this kind of concoction. Investigators have concluded that as-yet-unidentified individuals cooked up a protocol for a premix, a solution normally designed to fortify foods with vitamins or other nutrients but, in this case, it was poisonous. Several milk-collecting companies were using the same premix, Chen says: "So someone with technical skill had to be training them."
can obtain protein from at least some forms of non-protein nitrogen
(NPN) through fermentation by their rumen bacteria, hence NPN is often added to their diet to supplement protein. Nonruminants such as cats, dogs and pigs (and humans) cannot utilize NPN. NPN are given to ruminants in the form of pelleted urea
, ammonium phosphate
and/or biuret
. Sometimes slightly polymer
ized special urea-formaldehyde resin or a mixture of urea and formaldehyde
(both are also known as formaldehyde-treated urea) is used in place of urea, because the former provides a better control on the nitrogen release. This practice is carried out in China and other countries, such as Finland, India and France.
Cyanuric acid
has also been used as NPN. For example, Archer Daniels Midland
manufactures an NPN supplement for cattle, which contains biuret, triuret, cyanuric acid and urea. FDA permits a certain amount of cyanuric acid to be present in some additives used in animal feed and also drinking water.
Melamine use as NPN for cattle was described in a 1958 patent. In 1978, however, a study concluded that melamine "may not be an acceptable nonprotein N source for ruminants"，because its hydrolysis
in cattle is slower and less complete than other nitrogen sources such as cottonseed meal
and urea.
In China, it is known that ground urea-formaldehyde resin is a common adulterant in feed for non-ruminants. Domestically it is often sold under the euphemism "protein essence" (蛋白精) and is described as "one kind of new proteinnitrogen feed additive". However, urea-formaldehyde resin itself has been suggested as appropriate for use in feed for some non-ruminants in at least one UN FAO
report, suggesting its use as a binder in feed pellets in aquaculture.
There is at least one report of inexpensively priced rice protein concentrate (feed grade) containing non-protein nitrogen being marketed for use in non-ruminants dating back to 2005 . In a news item on its website, Jiangyin Hetai Industrial Co., Ltd. warned its customers of low-priced "PSEUDO rice protein" for sale in the market by another unnamed supplier, noting that the contaminant could be detected by analyzing the isoelectric point
. It is not clear from that report whether the contaminant in that case was melamine or some other non-protein nitrogen source or whether any contaminated rice protein concentrate made it into the food supply at that time.
On 18 Apr 2007, an ad was posted on the trading website Alibaba.com
selling "Esb protein powder" in Xuzhou Anying's name. The product is said to be protein in nature and suitable for livestock and poultry feed, yet claims a crude protein content of 160-300%. It also mentions in passing the product makes use of "NPN" which is an acronym for non-protein nitrogen. Similar ads were placed on other websites, some dated as early as 31 Oct 2005. Products with similar descriptions were also sold as "EM bacterium active protein forage" by Shandong Binzhou Xinpeng Biosciences Company and "HP protein powder" by Shandong Jinan Together Biologic Technology Development Company.
Proteins, unlike most other food components, contain nitrogen
, making nitrogen measurement a common surrogate for protein content. The standard tests for crude protein content used in the food industry (Kjeldahl method
and Dumas method
are used for official purposes) measure total nitrogen.
Accidental contamination
and intentional adulteration of protein meals with non-protein nitrogen sources that inflate crude protein content measurements have been known to occur in the food industry
for decades. To ensure food quality
, purchasers of protein meals routinely conduct quality control
tests designed to detect the most common non-protein nitrogen contaminants, such as urea
and ammonium nitrate.
At least one pet food manufacturer not involved in any recalls, The Honest Kitchen, has reacted to the news of melamine contamination by announcing that it would add melamine testing to the suite of quality control tests it already conducted on all ingredients it purchases.
In at least one other segment of the food industry, the dairy industry, some countries (at least the U.S., Australia, France and Hungary), have adopted "true protein" measurement, as opposed to crude protein measurement, as the standard for payment and testing: "True protein is a measure of only the proteins in milk, whereas crude protein is a measure of all sources of nitrogen and includes nonprotein nitrogen, such as urea, which has no food value to humans. ... Current milk-testing equipment measures peptide bonds, a direct measure of true protein." Measuring peptide bonds in grains has also been put into practice in several countries including Canada, the UK, Australia, Russia and Argentina where near-infrared reflectance (NIR) technology, a type of infrared spectroscopy
is used. The Food and Agriculture Organization of the United Nations (FAO) recommends that only amino acid analysis be used to determine protein in, inter alia, foods used as the sole source of nourishment, such as infant formula, but also provides: "When data on amino acids analyses are not available, determination of protein based on total N content by Kjeldahl (AOAC, 2000) or similar method ... is considered acceptable."
reported that melamine has also been purposely added as a binder
to fish and livestock feed manufactured in the United States and traced to suppliers in Ohio and Colorado.
In autumn 2008, the Food and Drug Administration
detected traces of melamine in one top-selling brand of infant formula and traces of cyanuric acid in another brand. Separately, a third major formula maker said that in-house tests had detected trace levels of melamine in its infant formula. The three firms manufacture more than 90 percent of all infant formula produced in the United States. The FDA and other experts said the melamine contamination in U.S.-made formula had occurred unintentionally during the manufacturing process and were not a safety concern.
, a similar chemical known to be found in the waste product of at least some methods of melamine production, and which combination some American and Canadian scientists have suggested may have led to the pet deaths through kidney failure.
On 25 May 2007 in a US FDA/CSFAN Interim Melamine and Analogues Safety/Risk Assessment, FDA stated: "While it is entirely possible that the analogues are more or less potent than the parent compound, melamine, we have no information that assesses the relative potency of the three analogues as compared to melamine; therefore, for the purpose of this interim assessment, we have made an assumption of equal potency. It has been hypothesized that melamine may interact synergistically with its three analogues, but no studies have been conducted that specifically test this hypothesis. Very preliminary work suggests that if it does occur, the formation of lattice crystals, particularly between melamine and cyanuric acid, takes place at very high dose levels and is a threshold and concentration dependent phenomenon that would not be relevant to low levels of exposure. Although still under investigation, it now appears that the combination of melamine and cyanuric acid has been linked to the acute renal failure in cats and dogs that have eaten the suspect pet foods...."
In the United States, five potential vectors of impact on the human food supply have been identified. The first, which has already been acknowledged to have occurred by FDA and U.S. Department of Agriculture officials, is via contaminated ingredients imported for use in pet foods and sold for use as salvage in animal feed which has been fed to some number of hogs and chickens, the meat from which has been processed and sold to some number of consumers: "There is very low risk to human health" in such cases involving pork and poultry. On 1 May 2007, the FDA and USDA stated that millions of chickens fed feed tainted with contaminated pet food had been consumed by an estimated 2.5 to 3 million people.
The second potential vector is via contaminated vegetable proteins imported for intended use as animal feed, which has apparently been acknowledged to occur with regard to fish feed in Canada, while the third possible route is via contaminated vegetable proteins imported for intended use in human food products, and the FDA has issued an import alert subjecting all Chinese vegetable proteins to detention without examination.
A fourth potential vector is referred to in the 10 May 2007 FDA-USDA press conference, viz. incorporation of contaminated vegetable proteins into products intended for human use and subsequent importation.
A fifth vector is acknowledged to have occurred in the 30 May 2007 FDA/USDA press conference, whereby U.S. manufacturers of livestock and shrimp/fish feed have acknowledged adding melamine to their products as a binder
.
The original Xuzhou Anying wheat gluten was "human grade," as opposed to "feed grade," meaning that it could have been used to make food for humans such as bread or pasta. At least one contaminated batch was used to make food for humans, but the FDA quarantined it before any was sold. The FDA also notified the Centers For Disease Control and Prevention to watch for new patients admitted to hospitals with renal failure. There have been no observed increases in human illnesses and little human food has tested as contaminated, however the FDA still has not accounted for all of the Xuzhou Anying wheat gluten.
Reports of widespread melamine adulteration in Chinese animal feed have raised the possibility of wider melamine contamination in the human food supply in China and abroad. Despite the widely reported ban on melamine use in vegetable proteins in China, at least some chemical manufacturers continue to report selling it for use in animal feed and in products for human consumption. Said Li Xiuping, a manager at Henan Xinxiang Huaxing Chemical in Henan Province: "Our chemical products are mostly used for additives, not for animal feed. Melamine is mainly used in the chemical industry, but it can also be used in making cakes."
In 2009, The World Health Organization
(WHO) published a report on a December 2008 expert meeting held in cojunction with the FAO
concluding, inter alia, that "a tolerable daily intake (TDI) of 0.2 mg/kg body weight for melamine was established. The TDI is applicable to the whole population, including infants." However, the experts also noted: "This TDI is applicable to exposure to melamine alone. ... Available data indicate that simultaneous exposure to
melamine and cyanuric acid is more toxic than exposures to each compound
individually. Data are not adequate to allow the calculation of a health-based guidance
value for this co-exposure."
On 3 April 2007, the Boston Globe reported that tainted wheat gluten ended up in factories that produce food for human consumption. Then, on 19 April, Federal U.S. officials said that they were investigating reports that Binzhou Futian rice protein had been used in hog feed, but declined to specify where. The California Department of Food and Agriculture placed American Hog Farm in Ceres, California
under quarantine, after melamine was found in the urine of the hogs on the farm. California State Veterinarian Dr. Richard Breitmeyer said "All animals appear healthy," and that "It is unknown if the chemical will be detected in meat." American Hog Farm primarily supplies whole hogs to individuals. Anyone who has purchased a pig from American Hog Farm since 3 April is advised not to eat it. According to California state officials, approximately 45 state residents consumed pork from hogs that had been fed melamine-contaminated feed.
On 24 April 2007, FDA officials said that melamine was in feed given to hogs (and in one case, in Missouri, to chickens) in California, New York, North Carolina, South Carolina, Utah and possibly Ohio. FDA also said that it was adding testing of imported ingredients and finished products that contain cornmeal, corn gluten, rice bran and soy protein to the tests it is already conducting for melamine in wheat gluten and rice protein concentrate ingredients and products.
Dr. David Acheson, assistant FDA commissioner for food protection, announced on 3 May that the FDA had begun to investigate domestic food manufacturers who use protein products to ensure that no contaminated product is being used in foods intended for human use, noting that it has no evidence of this occurring, "but it's prudent to look."
On 30 April 2007, the USDA and the FDA updated their 28 April food safety position to include poultry, reflecting contaminated feed being fed to chickens in Indiana.
Risks to human health from this mode of entering the human food supply have been said to be low according to a number of FDA, CDC
and university toxicologists, though it was acknowledged that how melamine had harmed cats and dogs "remains something of a mystery".
On 7 May 2007, the USDA and the FDA issued a joint press release reflecting the combined judgment of five federal agencies with regard to the risk to humans in consuming meat from animals fed feed contaminated with tainted pet food scraps, concluding: "There is very low risk to human health" in such cases involving pork and poultry. The risk assessment was conducted by scientists from FDA,the Food Safety and Inspection Service
(FSIS) of USDA, Centers for Disease Control and Prevention
(CDC), the Environmental Protection Agency
(EPA), and U.S. Customs and Border Protection
: "In the most extreme risk assessment scenario, when scientists assumed that all the solid food a person consumes in an entire day was contaminated with melamine at the levels observed in animals fed contaminated feed, the potential exposure was about 2,500 times lower than the dose considered safe" using criteria established prior to current research focusing on the apparent increased toxity related to the interaction of melamine and cyanuric acid in vivo for which there is no established safe dosage. FDA and USDA are in the process of identifying a group of experts to convene a scientific advisory board that would be charged with reviewing the risk assessment and contributing to future scientific analysis related to the risk of melamine and its compounds to humans and animals.
On 8 May 2007, some fish intended for human consumption was also announced as having consumed feed contaminated with tainted pet food scraps. According to the Assistant Commissioner for Food Safety of the FDA, "We do not believe that there is any significant risk associated with consuming these fish." Though the FDA declined to identify the states involved in the recall, the Oregon Department of Fish and Wildlife said contaminated fish feed had been found at the Marion Forks Hatchery. They also said that the company that provided the feed, Skretting, had shipped the same lot of feed to six other hatcheries in Oregon.
On 10 May 2007, on further inquiry into the risk to animal and human health of ingesting melamine and cyanuric acid in combination, Dr. David Acheson, Assistant Commissioner for Food Protection with the FDA said: "I'm not aware of any published studies on that. I have seen some preliminary data that would indicate that they are additive
. When you put the two together, they are additive rather than synergistic.... The risk assessors also estimated that even if synergism were to occur, it would be unlikely to result in more than a tenfold increase in overall toxicity, and that still gives you a very large margin of safety." No data supporting additivity was produced at this time. No basis for estimating a tenfold increase in risk in the case of synergism was offered.
On 15 May 2007, USDA announced that swine that ate melamine-tainted food have been cleared for human consumption. About 56,000 pigs have been affected in several states. However, no tests have been carried out on the effects of cyanuric acid in pork as well as possible effects of interaction with melamine in the body. While the statement also said that there is no evidence of bioaccumulation
of melamine alone, no mention was made whether bioaccumulation might be affected by the interaction of melamine and cyanuric acid in vivo particularly in swine kidneys.
On 3 October 2008 (updated 28 November 2008), in response to FDA learning that melamine might be contained in infant formula manufactured by a firm in China, FDA updated its 2007 interim risk assessment: "Infants may be more sensitive than adults to exposures because, for example, infant formula is the sole source of nutrition, exposure continues for up to 12 months, and renal function may be more immature compared to adults. This raises a high degree of uncertainty with regard to the determination of safety/risk. ... Therefore, if 100% of the diet were contaminated at a level of 1.26 ppm of melamine, an infant’s daily intake would equal 0.063 mg/kg bw/d. This value of 1.26 ppm is rounded down to 1.0 ppm melamine to provide an additional margin of safety."
These ingredients are used in such diverse products as breakfast cereal, pizza dough, baby formula, and protein shakes although at the time, there is "no evidence" that any contaminated ingredients have been used to produce human foods, according to Dr. David Acheson, chief medical officer at the FDA's Center for Food Safety and Applied Nutrition.
to use its surveillance network to monitor for signs of human illness, such as increased renal failure, that could indicate contamination of the human food supply."
On 2 May 2007, Bernadette Burden, a CDC spokeswoman, was reported as saying that a CDC survey of poison control centers, veterans’ hospitals and a sample of private hospitals had found no increase in reports of kidney diseases.
(FSIS) of the United States Department of Agriculture
(USDA) provides a test method for analyzing cyromazine and melamine in animal tissues in its Chemistry Laboratory Guidebook which "contains test methods used by FSIS Laboratories to support the Agency's inspection program, ensuring that meat, poultry, and egg products are safe, wholesome and accurately labeled."
On 24 April 2007, Stephen Sundlof, director of the FDA's Center for Veterinary Medicine, told reporters: "We have found cyanuric acid. It is somewhat related to melamine. Another compound that is very high in nitrogen and we are testing for that compound as well."
On 7 May 2007, the FDA sent a letter to food manufacturers, to remind them "of their legal responsibility to ensure that all ingredients used in their products are safe for human consumption." The FDA has made available to food manufacturers a procedure providing a general guide for the sample preparation and analysis of wheat gluten and pet food matrices for melamine using gas chromatography/mass spectrometry, the same methodology used by the FERN
laboratories.
On 15 May 2007, the process for testing meat from swine was validated by USDA's Food Safety and Inspection Service
(FSIS).
Organization (WHO) and the Food and Agriculture Organization of the United
Nations (FAO) convened an Expert Meeting.
Reports of melamine-contaminated product in Europe included, in October, 2008, when shops in Britain recalled chocolate erotic spreads from Chinese manufacturer "Le Bang" due to melamine contamination in excess of 100x the legal limit.
(EFSA), in EFSA's Provisional Statement on a Request from the European Commission Related to Melamine and Structurally Related Compounds such as Cyanuric acid in Protein-rich Ingredients Used for Food and Feed, concluded: "EFSA provisionally recommends to apply a TDI of 0.5 mg/kg b.w. for the total of melamine and its analogues .... A source of uncertainty is the combined toxicity of melamine and cyanuric acid and their possible synergistic effects in relation to the recently observed toxicity linked to the acute renal failure and death of pet animals (cats and dogs) in the U.S. This mechanism is currently under investigation."
On 21 June 2007, The Health & Consumer Protection Directorate-General of the European Commission
(EC) in reporting the Summary Minutes of the Meeting of the Standing Committee on the Food Chain and Animal Health (7 June & 8) acknowledged that corn gluten contaminated with melamine and rice protein concentrate contaminated with melamine and related compounds, both originating firom China, had been intercepted in Poland and Greece, respectively. The minutes further directed that "in case food producing animals have been fed with feed contaminated with melamine and related compounds, there is for the purpose of protecting human health, taking into account the conclusions of the EFSA statement, no need to take restrictive measures as regards the animals which have been fed with contaminated feed and as regards food of animal origin originating from animals fed with contaminated feed."
On 25 September 2008, EFSA issued a press release in response to reports of contaminated milk powder from China which stated, in part: "Children with a mean consumption of biscuits, milk toffee and chocolate made with such milk powder would also not exceed the TDI. However, in worst case scenarios with the highest level of contamination, children with high daily consumption of milk toffee, chocolate or biscuits containing high levels of milk powder would exceed the TDI. Children who consume both such biscuits and chocolate could potentially exceed the TDI by up to more than three times."
Once wheat gluten had been isolated as the source of the problems, federal investigators in the United States began to trace the gluten used in the foods. All of the gluten came from ChemNutra's Kansas City warehouse. ChemNutra said it imported nearly 800 metric tons of wheat gluten from the Xuzhou Anying Biologic Technology Development Company of Xuzhou
, Jiangsu, China
between 29 November and 8 March. ChemNutra says the gluten came directly from China or from China through the Netherlands
, and that it received no reports of contamination in the chemical analysis provided by Xuzhou Anying Biologic Technology Development Company. The products were shipped from the company's Kansas City
warehouse to several pet food makers and one distributor of pet food ingredients in the US and Canada, including the companies affected by the recall. Xuzhou Anying also exports carrots, garlic, ginger, corn protein powder, vegetables and feed.
On 5 April 2007, several days after the United States halted all wheat gluten imports, the Chinese government
categorically denied any connection to the North American food poisonings to the New York Times, claiming they had no record of exporting any agricultural products that could have tainted the recalled pet foods, including the wheat gluten that has been the focus of the investigation. The general manager of the Xuzhou Anying Biologic Technology Development Company also denied that they had exported any wheat gluten to North America
.
However, on 6 April 2007, the Chinese government told the Associated Press
they would investigate the source of the wheat gluten. Although the government refused to give details on the investigation, the Xinhua News Agency
stated that "sampling and examination" of wheat gluten was under way across China, centering on the presence of melamine. Officials with office of the General Administration of Quality Supervision, Inspection and Quarantine, said that they will stay in touch with the U.S. Embassy in Beijing
and that "further measures would be taken based on developments in the United States."
Starting on 4 April 2007, the Chinese government refused US FDA requests to inspect facilities suspected of producing contaminated products. On 11 April, the director of the FDA's field investigations division said he was disappointed with the Chinese response. On 23 April, after refusing for nearly a month, China finally gave permission to FDA investigators to enter the country.
On 25 April 2007, Chinese authorities shut down Binzhou Futian Biology Technology Co. Ltd., and detained the manager, Tian Feng. Feng has denied responsibility, saying that he "didn't do anything wrong," and denying that he even knew what melamine was. The following day, China's Foreign Ministry said it has banned the use of melamine in food products, admitting that products containing melamine had cleared customs while continuing to dispute the role of melamine in causing pet deaths. China also vowed to cooperate with U.S. investigators to find the "real cause" of pet deaths. China provided a transcript of the 26 April press conference indicating that an invitation to FDA investigators had been sent on 23 April, but making no mention of banning melamine usage.
On 3 May 2007, Chinese authorities detained Mao Lijun, general manager of the Xuzhou Anying Biologic Technology Development, one of the companies accused of exporting contaminated protein, on unspecified charges, perhaps showing that the Chinese government is taking additional steps in its own investigations and signaling cooperation with US FDA investigators who arrived in China on Monday.
On 9 May 2007, Chinese authorities took a number of steps to address food safety
concerns.
On 29 May 2007, in actions not linked directly to the protein export scandal, Xinhua reported that Zheng Xiaoyu
(郑筱萸), the former head of China's ministry of food and drug safety, had been convicted of personally approving unproven and unsafe medicines after taking bribes from eight pharmaceutical companies totaling more than 6.49 million RMB
, (or a rough equivalent of 850,000 US dollars), which resulted in at least hundreds of patient deaths, or perhaps even thousands, and as a result, he was sentenced to death. It was also discovered during his eight year reign as the head of China's ministry of food and drug safety, Zheng Xiaoyu had personally ordered the approval of more than 150,000 new medicines, an astonishing average of 134 times that of FDA, which only approves 140 or so new medicines annually. Not surprisingly, most of those 150,000 medicines were the products of the eight pharmaceutical companies that bribed Zheng Xiaoyu, and a single unsafe medication of Anhui
Hua Yuan (华源) Company (since closed with its CEO committed suicide before his arrest) resulted 14 patient deaths and hundreds being permanently disabled. Zheng Xiaoyu's former deputy was also convicted, for accepting more than two million RMB (or a rough equivalent of a quarter million US dollars) to help Zheng Xiaoyu. The former deputy was sentenced to a two year delayed death sentence and a new system for unsafe food recall would be implemented by the end of the year. However, the general public sentiment in China was that this was only the tip of the iceberg, because in the case of Zheng Xiaoyu, the exact amount of the bribe is much higher than what has been revealed so far, and this is confirmed by Zheng Xiaoyu's own confession: in March 2007, Zheng Xiaoyu admitted that the exact amount might never be known for sure because the 6.49 million was only what he accepted, and his wife and son also accepted separate huge bribes which he was not part of, and the investigation on Zheng Xiaoyu's family is still on-going. The Chinese public also believes that as the investigation deepens, the number of confirmed patients who died or were disabled would certainly increase.
In August 2007, Xinhua reported on a number of steps China had recently taken to ensure food safety and product quality, including instituting new product recall and customer notification systems.
In 2008, a number of steps were taken in China in response to the 2008 Chinese milk scandal
. A September 25, 2008 article from Xinhua is provided here as a link into some of the "Lessons Learned": "Sanlu, the center of the scandal, provided a bad example of crisis management. When it was first exposed, Sanlu refused to take the blame and passed the buck to innocent dairy farmers, which ignited great anger nationwide. A further official investigation showed Sanlu had lied about its contaminated baby formula for months while thousands of infants got sick and at least three died. Sanlu didn't openly admit its products were toxic until Sept. 11. It eventually recalled baby formula manufactured on and before Aug. 6."
and Canada
were voluntary, i.e. not mandated by any government agency. In the United States, prior to the recall, the Food and Drug Administration did not keep pet foods under the same level of protection and safety ensurance as food intended for human consumption. According to the FDA, the FDA's "regulation of pet food is similar to that for other animal feeds. The Federal Food, Drug, and Cosmetic Act (FFDCA) requires that pet foods, like human foods, be pure and wholesome, safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled." However, "there is no requirement that pet food products have premarket approval by FDA."
Once the recall was announced, the Food and Drug Administration immediately began to mobilize resources to assist in the investigation. The FDA has dedicated each of its 20 district offices and three field laboratories to the investigation and more than "400 employees are involved in sample pet food collection, monitoring of recall effectiveness, and preparing consumer complaint reports." The FDA has activated its Emergency Operations Center, making sure the information on the poisoning gets to scientists and inspection teams. The agency "is also working with its regulatory partners in all 50 state agriculture and health agencies to inform them of the status of the investigative and analytical efforts." The FDA issued an alert to its field personnel that they should block import of wheat gluten from Xuzhou Anying Biologic Technology Development Company Ltd., and subject wheat gluten from China and the Netherlands to increased scrutiny.
As a result of the contamination, consumers and pets' rights groups have called for the FDA to take a more active role in ensuring pet food safety. On 2 April 2007, People for the Ethical Treatment of Animals
called for the resignation of the FDA’s commissioner, Dr. Andrew von Eschenbach
. http://www.peta.org/pdfs/IGCFax.pdf
Possibly in response to growing concern about ensuring the safety of the U.S. food supply, on 1 May 2007, Dr. von Eschenbach announced the creation of an Assistant Commissioner for Food Protection to advise on "strategic and substantive food safety and food defense matters." Dr. David Acheson will fill this roll. According to Dr. von Eschenbach, "The protection of America's food supply and therefore the safety of Americans eating food of domestic or international origin is of utmost importance to me as a physician, and to the mission of this agency."
In the aftermath of the recall, there was a call from consumers for an investigation into Menu Foods reaction to the poisonings, and the federal government's stand on pet food safety and quality control and the FDA's response to the recall. On 1 April 2007, Senator Dick Durbin (D
- Illinois
) called on the FDA to "account for weak links in the pet food inspection system." Earlier in the week, Representative Rosa DeLauro
(D
- Connecticut
) asked for an analysis of the FDA's oversight of pet food manufacturing facilities and a report of actions taken since the recall.
On 6 April 2007, Senator Durbin criticized the federal inspection process for both human and pet food and called for the hearings on the matter. According to the Los Angeles Times
who interviewed Durbin 8 April, Durbin said he would like to see the FDA set national standards and inspection rules for pet food manufacturing facilities, and to see "federal law changed to allow the FDA to order a recall of food intended for human or pet consumption rather than rely on companies to do it voluntarily."
Durbin is working with Senator Herb Kohl
(D
- Wisconsin
), the Chairman of the United States Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies. Senator Kohl initiated hearings in the Senate Appropriations Subcommittee along with Senator Durbin and Senator Bob Bennett (R
- Utah
). Senator Robert Byrd
(D
- West Virginia
), from the United States Senate Committee on Appropriations
was there as well. Witnesses included FDA officials. They looked into several areas: the delay in reporting by Menu Foods, the lack of federal inspections of pet food facilities, and incomplete reporting by the FDA since the start of the recall.
During the hearing Senators Durbin and Byrd criticized the government's response during the recall. Durbin specifically criticized the lack of any regular inspection practices or quality control with regards to pet food safety. Senator Kohl criticized the FDA's communication to the public about recalled foods, noting that volunteer websites had more detailed and easier-to-access information about the extent of the problem and which specific foods are of concern than FDA's online resources which Kohl said was contradictory of itself at times, and which the FDA official giving testimony admitted to being difficult to navigate.
On 18 April 2007, Senator Durbin and Representative DeLauro met with US FDA Commissioner von Eschenbach to discuss the additional rice protein recalls and learned that the Chinese government was blocking outside attempts to investigate the contamination. In response, they sent a letter to Zhou Wenzong, China's Ambassador to the United States saying in part that "contaminated batches of wheat gluten and rice protein responsible for these events were imported from China" and that "no level of melamine should be found in pet or human food" and asking for visas for inspectors from the United States.
poll found that 92 percent of Americans favored "country of origin" labeling on meat products, while in a USA Today
/Gallup poll, 74 percent of US respondents said they were "somewhat concerned" or "very concerned" about the safety of food imported from China.
Melamine
Melamine is an organic base and a trimer of cyanamide, with a 1,3,5-triazine skeleton. Like cyanamide, it contains 66% nitrogen by mass and, if mixed with resins, has fire retardant properties due to its release of nitrogen gas when burned or charred, and has several other industrial uses....
and other compounds such as cyanuric acid
Cyanuric acid
Cyanuric acid or 1,3,5-triazine-2,4,6-triol is a chemical compound with the formula 3. Like many industrially useful chemicals, this triazine has many synonyms. This white, odorless solid finds use as a precursor or a component of bleaches, disinfectants, and herbicides...
, ammeline
Ammeline
Ammeline is a triazine. It is the hydrolysis product of melamine.-Synthesis:Ammeline can be synthesized by the pyrolysis of urea, or the condensation reaction amond 2 moles of dicyandiamide with 1 mole of biuret....
and ammelide
Ammelide
Ammelide is a triazine and the hydrolysis product of ammeline.-Synthesis:Ammelide can be obtained by heating dicyandiamide with aqueous ammonia at 160-170°C...
. These adulterants can be used to inflate the apparent protein content of products, so that inexpensive ingredients can pass for more expensive, concentrated proteins. Melamine by itself has not been thought to be very toxic to animals or humans except possibly in very high concentrations, but the combination of melamine and cyanuric acid has been implicated in kidney failure. Reports that cyanuric acid may be an independently and potentially widely-used adulterant
Adulterant
An adulterant is a chemical substance which should not be contained within other substances for legal or other reasons. Adulterants may be intentionally added to more expensive substances to increase visible quantities and reduce manufacturing costs or for some other deceptive or malicious purpose...
in China have heightened concerns for both animal and human health.
Chinese protein export contamination was first identified after the wide recall
Product recall
A product recall is a request to return to the maker a batch or an entire production run of a product, usually due to the discovery of safety issues. The recall is an effort to limit liability for corporate negligence and to improve or avoid damage to publicity...
of many brands of cat and dog food
Pet food
Pet food is plant or animal material intended for consumption by pets. Typically sold in pet stores and supermarkets, it is usually specific to the type of animal, such as dog food or cat food...
starting in March 2007 (the 2007 pet food recalls
2007 pet food recalls
The 2007 pet food recalls comprise the contamination and wide recall of many brands of cat and dog foods beginning in March 2007, and the ensuing developments involving the human food supply. The recalls in North America, Europe, and South Africa came in response to reports of renal failure in pets...
). The recalls in North America
North America
North America is a continent wholly within the Northern Hemisphere and almost wholly within the Western Hemisphere. It is also considered a northern subcontinent of the Americas...
, Europe and South Africa
South Africa
The Republic of South Africa is a country in southern Africa. Located at the southern tip of Africa, it is divided into nine provinces, with of coastline on the Atlantic and Indian oceans...
came in response to reports of kidney failure in pets. Several Chinese companies sold products claimed to be wheat gluten
Wheat gluten
Wheat gluten can refer to:* The gluten found in wheat, a sticky substance composed of the proteins gliadin and glutenin* Wheat gluten , a food prepared from these proteins, such as seitan or wheatmeat...
, rice
Rice
Rice is the seed of the monocot plants Oryza sativa or Oryza glaberrima . As a cereal grain, it is the most important staple food for a large part of the world's human population, especially in East Asia, Southeast Asia, South Asia, the Middle East, and the West Indies...
protein or corn
Maize
Maize known in many English-speaking countries as corn or mielie/mealie, is a grain domesticated by indigenous peoples in Mesoamerica in prehistoric times. The leafy stalk produces ears which contain seeds called kernels. Though technically a grain, maize kernels are used in cooking as a vegetable...
gluten, but which proved to be wheat flour
Wheat flour
Wheat flour is a powder made from the grinding of wheat used for human consumption. More wheat flour is produced than any other flour. Wheat varieties are called "clean," "white," or "brown" if they have high gluten content, and they are called "soft" or "weak" flour if gluten content is low...
adulterated with melamine
Melamine
Melamine is an organic base and a trimer of cyanamide, with a 1,3,5-triazine skeleton. Like cyanamide, it contains 66% nitrogen by mass and, if mixed with resins, has fire retardant properties due to its release of nitrogen gas when burned or charred, and has several other industrial uses....
, cyanuric acid
Cyanuric acid
Cyanuric acid or 1,3,5-triazine-2,4,6-triol is a chemical compound with the formula 3. Like many industrially useful chemicals, this triazine has many synonyms. This white, odorless solid finds use as a precursor or a component of bleaches, disinfectants, and herbicides...
, and other contaminants. The Chinese government
Government of the People's Republic of China
All power within the government of the People's Republic of China is divided among three bodies: the People's Republic of China, State Council, and the People's Liberation Army . This article is concerned with the formal structure of the state, its departments and their responsibilities...
was slow to respond, denying that vegetable protein was exported from China and refusing to allow foreign food safety investigators to enter the country. Ultimately, the Chinese government acknowledged that contamination had occurred and arrested the managers of two protein manufacturers identified so far and took other measures to improve food safety and product quality.
Reports of widespread adulteration of Chinese animal feed with melamine have raised the issue of melamine contamination in the human food supply both in China and abroad. On 27 April 2007, the U.S. Food and Drug Administration (FDA) subjected all vegetable proteins imported from China, intended for human or animal consumption, to detention without physical examination, including: Wheat Gluten, Rice Gluten, Rice Protein, Rice Protein Concentrate, Corn Gluten, Corn Gluten Meal, Corn By-Products, Soy Protein, Soy Gluten, Proteins (includes amino acids and protein hydrosylates), and Mung Bean Protein. In a teleconference with reporters on 1 May, officials from the FDA and U.S. Department of Agriculture said that between 2.5 and 3 million people in the United States had consumed chickens that had consumed feed containing contaminated vegetable protein from China. Reports that melamine has been added as a binder in animal feed manufactured in North America also raise the possibility that harmful melamine contamination might not be limited to China.
In September 2008, Sanlu Group
Sanlu Group
Sanlu Group was a state-owned Chinese dairy products company based in Shijiazhuang, the capital city of Hebei Province. It was one of the oldest and most popular brands of infant formula in China. New Zealand's Fonterra owned 43% of Sanlu....
had to recall baby formula
2008 Chinese milk scandal
The 2008 Chinese milk scandal was a food safety incident in the People's Republic of China, involving milk and infant formula, and other food materials and components, adulterated with melamine....
because it was contaminated with melamine. Around 294,000 babies in
China became ill after drinking the milk; at least six babies died.
As of July 2010, Chinese authorities were still reporting some seizures of melamine-contaminated dairy product in some provinces, though it was unclear whether these new contaminations constituted wholly new adulterations or were the result of illegal reuse of material from the 2008 adulterations.
History
The contaminated vegetable proteins were imported from China in 2006 and early 2007 and used as pet food ingredients. The process of identifying and accounting for the source of the contamination and for how the contaminant causes sickness is ongoing.The first recalls were announced by Menu Foods late on Friday, 16 March 2007 for cat and dog food products in the United States. By 30 March the United States began to ban imports of wheat gluten from China. The Chinese government responded on 4 April by categorically denying any connection to the North American food poisonings refusing to allow inspection of facilities suspected of producing contaminated products.
However, on 6 April 2007, the Chinese government told the Associated Press
Associated Press
The Associated Press is an American news agency. The AP is a cooperative owned by its contributing newspapers, radio and television stations in the United States, which both contribute stories to the AP and use material written by its staff journalists...
they would investigate the source of the wheat gluten and by 23 April China gave permission to FDA investigators to enter the country. On 25 April Chinese authorities began to shut down and destroy the implicated factories and detain their managers. The following day, China's Foreign Ministry said it had banned the use of melamine in food products, admitting that products containing melamine had cleared customs while continuing to dispute the role of melamine in causing pet deaths.
China also vowed to cooperate with U.S. investigators to find the "real cause" of pet deaths.
The United States Senate
United States Senate
The United States Senate is the upper house of the bicameral legislature of the United States, and together with the United States House of Representatives comprises the United States Congress. The composition and powers of the Senate are established in Article One of the U.S. Constitution. Each...
held an oversight hearing on the matter by 12 April. The economic impact on the pet food market has been extensive, with Menu Foods losing roughly $
United States dollar
The United States dollar , also referred to as the American dollar, is the official currency of the United States of America. It is divided into 100 smaller units called cents or pennies....
30 million alone from the recall.
On 24 April 2007, for the first time FDA officials said that melamine had been detected in feed given to animals raised for human consumption within the United States.
As of 7 May 2007, United States food safety officials stated: "There is very low risk to human health from consuming meat from hogs and chickens known to have been fed animal feed supplemented with pet food scraps that contained melamine and melamine-related compounds"
Investigations
In the 2007 outbreak, as all three pet food ingredients containing melamine had been imported from China, investigators focused their inquiries there. Another concern was raised by allegations that one contract manufacturer of pet food had included contaminated ingredients from China without the knowledge or approval of the pet food marketers. Melamine had also been purposely added as a binderBinder (material)
-See also:*Adhesive or Glue*Cement*Paint...
to fish feed manufactured in the United States from ingredients produced in Ohio. This adulteration has not been linked to any illness. The FDA issued a Warning Letter
FDA Warning Letter
The United States Food and Drug Adminstration defines a Warning Letter as "...a correspondence that notifies regulated industry about violations that FDA has documented during its inspections or investigations...
to Tembec, the manufacturer of the adulterated binding ingredients. In response, Tembec declared that, in addition to completing the recall of all products containing the adulterated binding ingredients, it would "discontinue manufacturing and marketing of
[the products] as aquatic feed binder. Tembec's aquatic feed binder products were also used by another US company, Uniscope, to produce a binder (XtraBond) for livestock feeds. This binder and the feeds made from it were not recalled, nor was the meat of the livestock fed on these feeds. No fish or fish products were recalled as a result of having been raised on the adulterated feeds.
In 2008, investigation of kidney problems in Chinese infants focused on domestic dairy suppliers in China.
Melamine production and use in China
Melamine is commonly produced from ureaUrea
Urea or carbamide is an organic compound with the chemical formula CO2. The molecule has two —NH2 groups joined by a carbonyl functional group....
, mainly by either catalyzed
Catalysis
Catalysis is the change in rate of a chemical reaction due to the participation of a substance called a catalyst. Unlike other reagents that participate in the chemical reaction, a catalyst is not consumed by the reaction itself. A catalyst may participate in multiple chemical transformations....
gas-phase
Gas
Gas is one of the three classical states of matter . Near absolute zero, a substance exists as a solid. As heat is added to this substance it melts into a liquid at its melting point , boils into a gas at its boiling point, and if heated high enough would enter a plasma state in which the electrons...
production or high pressure
High pressure
High pressure in science and engineering is studying the effects of high pressure on materials and the design and construction of devices, such as a diamond anvil cell, which can create high pressure...
liquid-phase
Liquid
Liquid is one of the three classical states of matter . Like a gas, a liquid is able to flow and take the shape of a container. Some liquids resist compression, while others can be compressed. Unlike a gas, a liquid does not disperse to fill every space of a container, and maintains a fairly...
production, and is soluble in water. Melamine is used combined with formaldehyde
Formaldehyde
Formaldehyde is an organic compound with the formula CH2O. It is the simplest aldehyde, hence its systematic name methanal.Formaldehyde is a colorless gas with a characteristic pungent odor. It is an important precursor to many other chemical compounds, especially for polymers...
to produce melamine resin
Melamine resin
Melamine resin or melamine formaldehyde is a hard, thermosetting plastic material made from melamine and formaldehyde by polymerization. In its butylated form, it is dissolved in n-butanol and xylene. It is then used to cross-link with alkyd, epoxy, acrylic and polyester resins, used in surface...
, a very durable thermosetting plastic
Thermosetting plastic
A thermosetting plastic, also known as a thermoset, is polymer material that irreversibly cures. The cure may be done through heat , through a chemical reaction , or irradiation such as electron beam processing.Thermoset materials are usually liquid or malleable prior to curing and designed to be...
, and melamine foam, a polymer
Polymer
A polymer is a large molecule composed of repeating structural units. These subunits are typically connected by covalent chemical bonds...
ic cleaning product. The end products include counter-tops, fabrics, glue
Glue
This is a list of various types of glue. Historically, the term "glue" only referred to protein colloids prepared from animal flesh. The meaning has been extended to refer to any fluid adhesive....
s and flame retardant
Flame retardant
Flame retardants are chemicals used in thermoplastics, thermosets, textiles and coatings that inhibit or resist the spread of fire. These can be separated into several different classes of chemicals:...
s. Occasionally, melamine-formaldehyde resin is added to gluten for non-food purposes, such as adhesives or fabric printing.
Melamine is also a byproduct of several pesticide
Pesticide
Pesticides are substances or mixture of substances intended for preventing, destroying, repelling or mitigating any pest.A pesticide may be a chemical unicycle, biological agent , antimicrobial, disinfectant or device used against any pest...
s, including cyromazine
Cyromazine
Cyromazine is a triazine insect growth regulator used as an insecticide and an acaricide. It is a cyclopropyl derivative of melamine. Cyromazine works by affecting the nervous system of the immature larval stages of certain insects....
. The Food Safety and Inspection Service
Food Safety and Inspection Service
The Food Safety and Inspection Service , an agency of the United States Department of Agriculture , is the public health agency responsible for ensuring that the nation's commercial supply of meat, poultry, and egg products is safe, wholesome, and correctly labeled and packaged...
(FSIS) of the United States Department of Agriculture
United States Department of Agriculture
The United States Department of Agriculture is the United States federal executive department responsible for developing and executing U.S. federal government policy on farming, agriculture, and food...
(USDA) provides a test method for analyzing cyromazine and melamine in animal tissues in its Chemistry Laboratory Guidebook which "contains test methods used by FSIS Laboratories to support the Agency's inspection program, ensuring that meat, poultry, and egg products are safe, wholesome and accurately labeled." In 1999, in a proposed rule published in the Federal Register
Federal Register
The Federal Register , abbreviated FR, or sometimes Fed. Reg.) is the official journal of the federal government of the United States that contains most routine publications and public notices of government agencies...
regarding cyromazine residue, the United States Environmental Protection Agency
United States Environmental Protection Agency
The U.S. Environmental Protection Agency is an agency of the federal government of the United States charged with protecting human health and the environment, by writing and enforcing regulations based on laws passed by Congress...
(EPA) proposed "remov[ing] melamine, a metabolite
Metabolite
Metabolites are the intermediates and products of metabolism. The term metabolite is usually restricted to small molecules. A primary metabolite is directly involved in normal growth, development, and reproduction. Alcohol is an example of a primary metabolite produced in large-scale by industrial...
of cyromazine from the tolerance expression since it is no longer considered a residue of concern."
Melamine production in China has also been reported as using coal
Coal
Coal is a combustible black or brownish-black sedimentary rock usually occurring in rock strata in layers or veins called coal beds or coal seams. The harder forms, such as anthracite coal, can be regarded as metamorphic rock because of later exposure to elevated temperature and pressure...
as raw material. This production has been described as also producing "melamine scrap" which is not "pure melamine but impure melamine scrap that is sold more cheaply as the waste product after melamine is produced by chemical and fertilizer factories here." Shandong Mingshui Great Chemical Group, the company reported by the New York Times as producing melamine from coal
Coal
Coal is a combustible black or brownish-black sedimentary rock usually occurring in rock strata in layers or veins called coal beds or coal seams. The harder forms, such as anthracite coal, can be regarded as metamorphic rock because of later exposure to elevated temperature and pressure...
, produces and sells both urea
Urea
Urea or carbamide is an organic compound with the chemical formula CO2. The molecule has two —NH2 groups joined by a carbonyl functional group....
and melamine
Melamine
Melamine is an organic base and a trimer of cyanamide, with a 1,3,5-triazine skeleton. Like cyanamide, it contains 66% nitrogen by mass and, if mixed with resins, has fire retardant properties due to its release of nitrogen gas when burned or charred, and has several other industrial uses....
but does not list melamine resin
Melamine resin
Melamine resin or melamine formaldehyde is a hard, thermosetting plastic material made from melamine and formaldehyde by polymerization. In its butylated form, it is dissolved in n-butanol and xylene. It is then used to cross-link with alkyd, epoxy, acrylic and polyester resins, used in surface...
as a product. Melamine production in China has increased greatly in recent years and was described as in "serious surplus" in 2006 . In the United States Geological Survey
United States Geological Survey
The United States Geological Survey is a scientific agency of the United States government. The scientists of the USGS study the landscape of the United States, its natural resources, and the natural hazards that threaten it. The organization has four major science disciplines, concerning biology,...
2004 Minerals Survey Yearbook, in a report on worldwide nitrogen
Nitrogen
Nitrogen is a chemical element that has the symbol N, atomic number of 7 and atomic mass 14.00674 u. Elemental nitrogen is a colorless, odorless, tasteless, and mostly inert diatomic gas at standard conditions, constituting 78.08% by volume of Earth's atmosphere...
production, the author stated that "China continued to plan and construct new ammonia and urea plants using coal gasification
Coal gasification
Coal gasification is the process of producing coal gas, a type of syngas–a mixture of carbon monoxide , hydrogen , carbon dioxide and water vapour –from coal...
technology."
The off-gas in production contains large amounts of ammonia (see melamine synthesis). Therefore melamine production is often integrated into urea production which uses ammonia as feedstock. Crystallization and washing of melamine generates a considerable amount of waste water, which is a pollutant if discharged directly into the environment. The waste water may be concentrated into a solid (1.5-5% of the weight) for easier disposal. The solid may contain approximately
70% melamine, 23% oxytriazines (ammeline
Ammeline
Ammeline is a triazine. It is the hydrolysis product of melamine.-Synthesis:Ammeline can be synthesized by the pyrolysis of urea, or the condensation reaction amond 2 moles of dicyandiamide with 1 mole of biuret....
, ammelide
Ammelide
Ammelide is a triazine and the hydrolysis product of ammeline.-Synthesis:Ammelide can be obtained by heating dicyandiamide with aqueous ammonia at 160-170°C...
and cyanuric acid
Cyanuric acid
Cyanuric acid or 1,3,5-triazine-2,4,6-triol is a chemical compound with the formula 3. Like many industrially useful chemicals, this triazine has many synonyms. This white, odorless solid finds use as a precursor or a component of bleaches, disinfectants, and herbicides...
), 0.7% polycondensates (melem
Melem
A heptazine, or tri-s-triazine or cyamelurine, is a type of chemical compound that consist of a planar triangular core group, C6N7, or three fused triazine rings, with three substituents at the corners of the triangle....
, melam
Melam (chemistry)
Melam is a condensation product of melamine.-Synthesis:Melam was discovered by Liebig in 1834 from the residue of heating ammonium thiocyanate.-Chemical property:...
and melon).
In January 2009, China's Ministry of Industry and Information Technology promulgated draft production permit rules aiming to stem a melamine production glut. Melamine had been widely sold, including over the Internet, for around 10,000 yuan ($1,500) a metric tonne. The ministry also aimed to shrink the number of melamine producers by setting minimum production levels and strengthening controls on ingredients and waste.
Suspicion of contamination in China
Melamine manufacturing and the chemical processes in which melamine are used are completely unrelated to the manufacture or processing of food products such as wheat gluten. On 9 April the FDA stated that there is a "distinct possibility" that the food was intentionally contaminated. According to Senator Richard J. Durbin, one theory that investigators are exploring is whether melamine was added to fraudulently increase the measured protein content, which determines the value of the product.Some analysis methods for determining protein content actually measure the amount of nitrogen present, on the assumption that only protein in the sample contributes significantly to its nitrogen content. Melamine contains a very high proportion of nitrogen. According to Liu Laiting, a Chinese professor of animal sciences, melamine is also hard to detect in ordinary tests.
Glutens
Xuzhou Anying Biologic Technology Development Company (徐州安营生物技术开发有限公司), an agricultural products company based in XuzhouXuzhou
Xuzhou , otherwise known as Pengcheng in ancient times, is a major city in and the fourth largest prefecture-level city of Jiangsu province, People's Republic of China...
, Jiangsu, China, which U.S. officials believe was the source of the melamine-contaminated gluten, are maintaining innocence and assert that they are cooperating with officials. The general manager for Xuzhou Anying has denied that his company exported goods and says that they are researching who might have exported their product. They note that per Chinese law, all exported wheat gluten is tested and that they were simply a middle man
Reseller
A reseller is a company or individual that purchases goods or services with the intention of reselling them rather than consuming or using them. This is usually done for profit...
for local producers. However, a truck driver who has carried goods for Xuzhou Anying contradicted this, saying "they have a factory that makes wheat gluten." Officials in the USDA and FDA believe that Xuzhou Anying labeled its wheat gluten as "nonfood" and exported through a third party, Suzhou Textiles Silk Light & Industrial Products. The nonfood designation would allow the gluten to be shipped without inspection, however a spokesman for Suzhou Textiles has denied that the company exported any wheat gluten.
There is evidence that Xuzhou Anying, despite being a food ingredient supplier, has sought out large quantities of melamine in the past. The New York Times
The New York Times
The New York Times is an American daily newspaper founded and continuously published in New York City since 1851. The New York Times has won 106 Pulitzer Prizes, the most of any news organization...
has reported that as recently as 29 March 2007, representatives of Xuzhou Anying wrote, "Our company buys large quantities of melamine scrap" on a message board for the trading of industrial materials. Melamine may have been added to enhance the apparent protein content of the wheat gluten. However, the importer of the wheat gluten, ChemNutra
ChemNutra
ChemNutra is a Summerlin, Nevada based importer of ingredients for food, animal feed and pharmaceuticals. Self-described as "The China-Source Experts" they import their products from China and provide them to North American manufacturers. The Chief Executive Officer is Stephen S...
, claims that they received from Xuzhou Anying results of analyses showing "no impurities or contamination." It has not yet been determined whether Xuzhou Anying products other than wheat gluten have been shipped to North America.
The second Chinese supplier involved in shipping melamine-contaminated food ingredients, Binzhou Futian Biology Technology, has been working with importer Wilbur-Ellis since July 2006 . Binzhou Futian supplies soy, corn and other proteins to the United States, Europe and Southeast Asia. Binzhou typically ships rice protein concentrate in white bags but on 11 April one bag was pink and had the word "melamine" stenciled on it. Binzhou explained to Wilbur-Ellis that the original bag had broken and a mislabeled, but new, bag had been used. The company only supplies food and feed ingredients.
Stephen Sundlof, director of the FDA's Center for Veterinary Medicine, said that melamine turning up in exported Chinese wheat gluten, rice protein concentrate and corn gluten supports theories of intentional adulteration. "That will be one of the theories we will pursue when we get into the plants in China."
On 29 April 2007 and 30 April 2007, the International Herald Tribune
International Herald Tribune
The International Herald Tribune is a widely read English language international newspaper. It combines the resources of its own correspondents with those of The New York Times and is printed at 38 sites throughout the world, for sale in more than 160 countries and territories...
and New York Times reported that some animal feed manufacturers in China admit to having used melamine scrap in animal feed for years. Said Ji Denghui, general manager of the Fujian Sanming Dinghui Chemical Company: “Many companies buy melamine scrap to make animal feed, such as fish feed. 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.” Such use of "melamine scrap", described as leftover from processing of coal into melamine for use in creating plastic and fertilizer, was described as widespread. Melamine is said to have been chosen in order to inflate crude protein content measures and to avoid tests for other common and illegal ingredients, such as urea
Urea
Urea or carbamide is an organic compound with the chemical formula CO2. The molecule has two —NH2 groups joined by a carbonyl functional group....
.
As of 2 May 2007, officials of the USDA and FDA still do not know who manufactured the contaminated food or where the contamination took place. The Chinese government has said that Xuzhou Anying, for instance, purchased its products from 25 different manufacturers.
On 8 May 2007, The International Herald Tribune
International Herald Tribune
The International Herald Tribune is a widely read English language international newspaper. It combines the resources of its own correspondents with those of The New York Times and is printed at 38 sites throughout the world, for sale in more than 160 countries and territories...
reported that three Chinese chemical makers have said that animal feed producers often purchase, or seek to purchase, the chemical, cyanuric acid, from their factories to blend into animal feed to give the false appearance of a higher level of protein, suggesting another potentially dangerous way that melamine and cyanuric acid might combine in protein products.
The same day, FDA officials revealed that the vegetable proteins were not only contaminated, but mislabeled. Both the wheat gluten and rice protein concentrate were actually wheat flour, a much cheaper product from which wheat gluten is extracted. The addition of nitrogen-rich compounds were necessary to make the flour test as if it were protein extract.
Dairy
On 11 September 2008, fresh reports of massive outbreak of melamine contamination2008 Chinese milk scandal
The 2008 Chinese milk scandal was a food safety incident in the People's Republic of China, involving milk and infant formula, and other food materials and components, adulterated with melamine....
found in China led to recall of Baby Formula products in China. Some Chinese reports said the manufacturer of the milk products might not have consciously added Melamine to their milk powder, however they could have used a soy protein substitute to lower production costs, and the source of their soy substitute had melamine added to it. Many Chinese babies had developed kidney stones and other acute kidney problems in recent months across China, investigation led to the discovery of this contaminant. Some people were wondering how much melamine has already entered food products designated for adults without discovery. More worrying are claims reported in China that there are now new chemicals that can be added to food to lower production costs, and yet pass the tests for melamine and other related chemicals. Impact of this incident to dairy industry outside China is beginning to unravel.
By the end of September 2008, the Chinese government said that 22 dairy companies, including Sanlu and export brands like Mengniu and Yili, had produced powdered baby formula that contained traces of melamine. Some dairy farmers interviewed in Hebei Province said it was an open secret that milk was adulterated. Some dairies routinely watered down milk to increase profits, then added other cheap ingredients so the milk could pass a protein test. "Before melamine, the dealers added rice porridge or starch into the milk to artificially boost the protein count, but that method was easily tested as fake, so they switched to melamine,” said Zhao Huibin, a dairy farmer near Shijiazhuang.
Investigators say the adulteration was nothing short of a wholesale re-engineering of milk. Researchers established that workers at Sanlu and at a number of milk-collection depots were diluting milk with water; they added melamine to dupe a test for determining crude protein content. "Adulteration used to be simple. What they did was very high-tech," says Chen Junshi, co-chair of the Sino-U.S. workshop and a risk-assessment specialist at China's Center for Disease Control and Prevention. Investigators subsequently learned that the emulsifier used to suspend melamine also boosted apparent milk-fat content. Sanlu baby formula contained a whopping 2563 mg/kg of melamine, adding 1% of apparent crude protein content to the formula, where normal milk is 3.0% to 3.4% protein. Chen says a dean of a school of food science told him that it would take a university team 3 months to develop this kind of concoction. Investigators have concluded that as-yet-unidentified individuals cooked up a protocol for a premix, a solution normally designed to fortify foods with vitamins or other nutrients but, in this case, it was poisonous. Several milk-collecting companies were using the same premix, Chen says: "So someone with technical skill had to be training them."
Non-protein nitrogen as a feed additive
Ruminant animalsRuminant
A ruminant is a mammal of the order Artiodactyla that digests plant-based food by initially softening it within the animal's first compartment of the stomach, principally through bacterial actions, then regurgitating the semi-digested mass, now known as cud, and chewing it again...
can obtain protein from at least some forms of non-protein nitrogen
Non-protein nitrogen
Non-protein nitrogen is a term used in animal nutrition to refer collectively to components such as urea, biuret, and ammonia, which are not proteins but can be converted into proteins by microbes in the ruminant stomach...
(NPN) through fermentation by their rumen bacteria, hence NPN is often added to their diet to supplement protein. Nonruminants such as cats, dogs and pigs (and humans) cannot utilize NPN. NPN are given to ruminants in the form of pelleted urea
Urea
Urea or carbamide is an organic compound with the chemical formula CO2. The molecule has two —NH2 groups joined by a carbonyl functional group....
, ammonium phosphate
Ammonium phosphate
Ammonium phosphate is the salt of ammonia and phosphoric acid. It has the formula 3PO4 and consists of ammonium cations and phosphate anion. It is obtained as a crystalline powder upon mixing concentrated solutions of ammonia and phosphoric acid, or on the addition of excess of ammonia to the...
and/or biuret
Biuret
Biuret is a chemical compound with the chemical formula H2NCNHCNH2. It is the result of condensation of two molecules of urea and is a problematic impurity in urea-based fertilizers. This white solid is soluble in hot water....
. Sometimes slightly polymer
Polymer
A polymer is a large molecule composed of repeating structural units. These subunits are typically connected by covalent chemical bonds...
ized special urea-formaldehyde resin or a mixture of urea and formaldehyde
Formaldehyde
Formaldehyde is an organic compound with the formula CH2O. It is the simplest aldehyde, hence its systematic name methanal.Formaldehyde is a colorless gas with a characteristic pungent odor. It is an important precursor to many other chemical compounds, especially for polymers...
(both are also known as formaldehyde-treated urea) is used in place of urea, because the former provides a better control on the nitrogen release. This practice is carried out in China and other countries, such as Finland, India and France.
Cyanuric acid
Cyanuric acid
Cyanuric acid or 1,3,5-triazine-2,4,6-triol is a chemical compound with the formula 3. Like many industrially useful chemicals, this triazine has many synonyms. This white, odorless solid finds use as a precursor or a component of bleaches, disinfectants, and herbicides...
has also been used as NPN. For example, Archer Daniels Midland
Archer Daniels Midland
The Archer Daniels Midland Company is a conglomerate headquartered in Decatur, Illinois. ADM operates more than 270 plants worldwide, where cereal grains and oilseeds are processed into products used in food, beverage, nutraceutical, industrial and animal feed markets worldwide.ADM was named the...
manufactures an NPN supplement for cattle, which contains biuret, triuret, cyanuric acid and urea. FDA permits a certain amount of cyanuric acid to be present in some additives used in animal feed and also drinking water.
Melamine use as NPN for cattle was described in a 1958 patent. In 1978, however, a study concluded that melamine "may not be an acceptable nonprotein N source for ruminants"，because its hydrolysis
Hydrolysis
Hydrolysis is a chemical reaction during which molecules of water are split into hydrogen cations and hydroxide anions in the process of a chemical mechanism. It is the type of reaction that is used to break down certain polymers, especially those made by condensation polymerization...
in cattle is slower and less complete than other nitrogen sources such as cottonseed meal
Cottonseed meal
Cottonseed meal is the byproduct remaining after cotton is ginned and the seeds crushed and the oil extracted. The remaining meal is usually used for animal feed and in organic fertilizers. However, the meal can be fed only to adult ruminants because it contains a compound called gossypol...
and urea.
In China, it is known that ground urea-formaldehyde resin is a common adulterant in feed for non-ruminants. Domestically it is often sold under the euphemism "protein essence" (蛋白精) and is described as "one kind of new proteinnitrogen feed additive". However, urea-formaldehyde resin itself has been suggested as appropriate for use in feed for some non-ruminants in at least one UN FAO
Fão
Fão is a town in Esposende Municipality in Portugal....
report, suggesting its use as a binder in feed pellets in aquaculture.
There is at least one report of inexpensively priced rice protein concentrate (feed grade) containing non-protein nitrogen being marketed for use in non-ruminants dating back to 2005 . In a news item on its website, Jiangyin Hetai Industrial Co., Ltd. warned its customers of low-priced "PSEUDO rice protein" for sale in the market by another unnamed supplier, noting that the contaminant could be detected by analyzing the isoelectric point
Isoelectric point
The isoelectric point , sometimes abbreviated to IEP, is the pH at which a particular molecule or surface carries no net electrical charge....
. It is not clear from that report whether the contaminant in that case was melamine or some other non-protein nitrogen source or whether any contaminated rice protein concentrate made it into the food supply at that time.
On 18 Apr 2007, an ad was posted on the trading website Alibaba.com
Alibaba.com
Alibaba Group is a privately owned Hangzhou, China-based family of Internet-based businesses that includes online marketplaces that facilitate business-to-business international and domestic China trade, retail and payment platforms, a shopping search engine, and data-centric cloud computing...
selling "Esb protein powder" in Xuzhou Anying's name. The product is said to be protein in nature and suitable for livestock and poultry feed, yet claims a crude protein content of 160-300%. It also mentions in passing the product makes use of "NPN" which is an acronym for non-protein nitrogen. Similar ads were placed on other websites, some dated as early as 31 Oct 2005. Products with similar descriptions were also sold as "EM bacterium active protein forage" by Shandong Binzhou Xinpeng Biosciences Company and "HP protein powder" by Shandong Jinan Together Biologic Technology Development Company.
Protein testing
Nitrogen
Nitrogen is a chemical element that has the symbol N, atomic number of 7 and atomic mass 14.00674 u. Elemental nitrogen is a colorless, odorless, tasteless, and mostly inert diatomic gas at standard conditions, constituting 78.08% by volume of Earth's atmosphere...
, making nitrogen measurement a common surrogate for protein content. The standard tests for crude protein content used in the food industry (Kjeldahl method
Kjeldahl method
The Kjeldahl method or Kjeldahl digestion in analytical chemistry is a method for the quantitative determination of nitrogen in chemical substances developed by Johan Kjeldahl in 1883.- Method :...
and Dumas method
Dumas method
The Dumas method in analytical chemistry is a method for the quantitative determination of nitrogen in chemical substances based on a method first described by Jean-Baptiste Dumas over a century and a half ago....
are used for official purposes) measure total nitrogen.
Accidental contamination
Contamination
Contamination is the presence of a minor and unwanted constituent in material, physical body, natural environment, at a workplace, etc.-Specifics:"Contamination" also has more specific meanings in science:...
and intentional adulteration of protein meals with non-protein nitrogen sources that inflate crude protein content measurements have been known to occur in the food industry
Food industry
The food production is a complex, global collective of diverse businesses that together supply much of the food energy consumed by the world population...
for decades. To ensure food quality
Food quality
Food quality is the quality characteristics of food that is acceptable to consumers. This includes external factors as appearance , texture, and flavour; factors such as federal grade standards and internal .Food quality in the United States is enforced by the Food Safety Act 1990...
, purchasers of protein meals routinely conduct quality control
Quality control
Quality control, or QC for short, is a process by which entities review the quality of all factors involved in production. This approach places an emphasis on three aspects:...
tests designed to detect the most common non-protein nitrogen contaminants, such as urea
Urea
Urea or carbamide is an organic compound with the chemical formula CO2. The molecule has two —NH2 groups joined by a carbonyl functional group....
and ammonium nitrate.
At least one pet food manufacturer not involved in any recalls, The Honest Kitchen, has reacted to the news of melamine contamination by announcing that it would add melamine testing to the suite of quality control tests it already conducted on all ingredients it purchases.
In at least one other segment of the food industry, the dairy industry, some countries (at least the U.S., Australia, France and Hungary), have adopted "true protein" measurement, as opposed to crude protein measurement, as the standard for payment and testing: "True protein is a measure of only the proteins in milk, whereas crude protein is a measure of all sources of nitrogen and includes nonprotein nitrogen, such as urea, which has no food value to humans. ... Current milk-testing equipment measures peptide bonds, a direct measure of true protein." Measuring peptide bonds in grains has also been put into practice in several countries including Canada, the UK, Australia, Russia and Argentina where near-infrared reflectance (NIR) technology, a type of infrared spectroscopy
Infrared spectroscopy
Infrared spectroscopy is the spectroscopy that deals with the infrared region of the electromagnetic spectrum, that is light with a longer wavelength and lower frequency than visible light. It covers a range of techniques, mostly based on absorption spectroscopy. As with all spectroscopic...
is used. The Food and Agriculture Organization of the United Nations (FAO) recommends that only amino acid analysis be used to determine protein in, inter alia, foods used as the sole source of nourishment, such as infant formula, but also provides: "When data on amino acids analyses are not available, determination of protein based on total N content by Kjeldahl (AOAC, 2000) or similar method ... is considered acceptable."
Allegations of manufacturing and product tampering
The 26 April 2007 and 27 April 2007 recalls by Blue Buffalo, Diamond, Harmony Farms, and Natural Balance are claimed by all 4 brands to be due to unauthorized inclusion of rice protein by American Nutrition, Inc. (ANI), their manufacturer. This adds a new potential source of contamination and distrust, namely non-compliant contract manufacturers, beyond the original problematic Chinese ingredient suppliers. Diamond and Natural Balance refer to this as a "manufacturing deviation" by ANI. Blue Buffalo and Harmony Farms characterize this as "product tampering" by ANI. ANI's recall notice makes no comment on these allegations.Melamine adulteration and contamination in the U.S.
On 31 May 2007, the International Herald TribuneInternational Herald Tribune
The International Herald Tribune is a widely read English language international newspaper. It combines the resources of its own correspondents with those of The New York Times and is printed at 38 sites throughout the world, for sale in more than 160 countries and territories...
reported that melamine has also been purposely added as a binder
Binder (material)
-See also:*Adhesive or Glue*Cement*Paint...
to fish and livestock feed manufactured in the United States and traced to suppliers in Ohio and Colorado.
In autumn 2008, the Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
detected traces of melamine in one top-selling brand of infant formula and traces of cyanuric acid in another brand. Separately, a third major formula maker said that in-house tests had detected trace levels of melamine in its infant formula. The three firms manufacture more than 90 percent of all infant formula produced in the United States. The FDA and other experts said the melamine contamination in U.S.-made formula had occurred unintentionally during the manufacturing process and were not a safety concern.
Impact on human food supply
In early 2007, U.S. officials publicly said that they do not believe melamine alone to be harmful to humans. However, there was too little data at that time to determine how it reacts with other substances, in particular, the combination of melamine with cyanuric acidCyanuric acid
Cyanuric acid or 1,3,5-triazine-2,4,6-triol is a chemical compound with the formula 3. Like many industrially useful chemicals, this triazine has many synonyms. This white, odorless solid finds use as a precursor or a component of bleaches, disinfectants, and herbicides...
, a similar chemical known to be found in the waste product of at least some methods of melamine production, and which combination some American and Canadian scientists have suggested may have led to the pet deaths through kidney failure.
On 25 May 2007 in a US FDA/CSFAN Interim Melamine and Analogues Safety/Risk Assessment, FDA stated: "While it is entirely possible that the analogues are more or less potent than the parent compound, melamine, we have no information that assesses the relative potency of the three analogues as compared to melamine; therefore, for the purpose of this interim assessment, we have made an assumption of equal potency. It has been hypothesized that melamine may interact synergistically with its three analogues, but no studies have been conducted that specifically test this hypothesis. Very preliminary work suggests that if it does occur, the formation of lattice crystals, particularly between melamine and cyanuric acid, takes place at very high dose levels and is a threshold and concentration dependent phenomenon that would not be relevant to low levels of exposure. Although still under investigation, it now appears that the combination of melamine and cyanuric acid has been linked to the acute renal failure in cats and dogs that have eaten the suspect pet foods...."
In the United States, five potential vectors of impact on the human food supply have been identified. The first, which has already been acknowledged to have occurred by FDA and U.S. Department of Agriculture officials, is via contaminated ingredients imported for use in pet foods and sold for use as salvage in animal feed which has been fed to some number of hogs and chickens, the meat from which has been processed and sold to some number of consumers: "There is very low risk to human health" in such cases involving pork and poultry. On 1 May 2007, the FDA and USDA stated that millions of chickens fed feed tainted with contaminated pet food had been consumed by an estimated 2.5 to 3 million people.
The second potential vector is via contaminated vegetable proteins imported for intended use as animal feed, which has apparently been acknowledged to occur with regard to fish feed in Canada, while the third possible route is via contaminated vegetable proteins imported for intended use in human food products, and the FDA has issued an import alert subjecting all Chinese vegetable proteins to detention without examination.
A fourth potential vector is referred to in the 10 May 2007 FDA-USDA press conference, viz. incorporation of contaminated vegetable proteins into products intended for human use and subsequent importation.
A fifth vector is acknowledged to have occurred in the 30 May 2007 FDA/USDA press conference, whereby U.S. manufacturers of livestock and shrimp/fish feed have acknowledged adding melamine to their products as a binder
Binder (material)
-See also:*Adhesive or Glue*Cement*Paint...
.
The original Xuzhou Anying wheat gluten was "human grade," as opposed to "feed grade," meaning that it could have been used to make food for humans such as bread or pasta. At least one contaminated batch was used to make food for humans, but the FDA quarantined it before any was sold. The FDA also notified the Centers For Disease Control and Prevention to watch for new patients admitted to hospitals with renal failure. There have been no observed increases in human illnesses and little human food has tested as contaminated, however the FDA still has not accounted for all of the Xuzhou Anying wheat gluten.
Reports of widespread melamine adulteration in Chinese animal feed have raised the possibility of wider melamine contamination in the human food supply in China and abroad. Despite the widely reported ban on melamine use in vegetable proteins in China, at least some chemical manufacturers continue to report selling it for use in animal feed and in products for human consumption. Said Li Xiuping, a manager at Henan Xinxiang Huaxing Chemical in Henan Province: "Our chemical products are mostly used for additives, not for animal feed. Melamine is mainly used in the chemical industry, but it can also be used in making cakes."
In 2009, The World Health Organization
World Health Organization
The World Health Organization is a specialized agency of the United Nations that acts as a coordinating authority on international public health. Established on 7 April 1948, with headquarters in Geneva, Switzerland, the agency inherited the mandate and resources of its predecessor, the Health...
(WHO) published a report on a December 2008 expert meeting held in cojunction with the FAO
Fão
Fão is a town in Esposende Municipality in Portugal....
concluding, inter alia, that "a tolerable daily intake (TDI) of 0.2 mg/kg body weight for melamine was established. The TDI is applicable to the whole population, including infants." However, the experts also noted: "This TDI is applicable to exposure to melamine alone. ... Available data indicate that simultaneous exposure to
melamine and cyanuric acid is more toxic than exposures to each compound
individually. Data are not adequate to allow the calculation of a health-based guidance
value for this co-exposure."
Background
Ceres, California
Ceres is a city in Stanislaus County, California, United States. The population was 45,417 at the 2010 census, up from 34,609 at the 2000 census. It is part of the Modesto Metropolitan Statistical Area.-General:...
under quarantine, after melamine was found in the urine of the hogs on the farm. California State Veterinarian Dr. Richard Breitmeyer said "All animals appear healthy," and that "It is unknown if the chemical will be detected in meat." American Hog Farm primarily supplies whole hogs to individuals. Anyone who has purchased a pig from American Hog Farm since 3 April is advised not to eat it. According to California state officials, approximately 45 state residents consumed pork from hogs that had been fed melamine-contaminated feed.
On 24 April 2007, FDA officials said that melamine was in feed given to hogs (and in one case, in Missouri, to chickens) in California, New York, North Carolina, South Carolina, Utah and possibly Ohio. FDA also said that it was adding testing of imported ingredients and finished products that contain cornmeal, corn gluten, rice bran and soy protein to the tests it is already conducting for melamine in wheat gluten and rice protein concentrate ingredients and products.
Dr. David Acheson, assistant FDA commissioner for food protection, announced on 3 May that the FDA had begun to investigate domestic food manufacturers who use protein products to ensure that no contaminated product is being used in foods intended for human use, noting that it has no evidence of this occurring, "but it's prudent to look."
FDA/USDA acknowledge contaminated food supply
On 28 April 2007, the USDA and the FDA, in a joint press release acknowledged that pork from hogs fed contaminated feed had entered the human food supply, stating: "Based on information currently available, FDA and USDA believe the likelihood of illness after eating pork from swine fed the contaminated product would be very low."On 30 April 2007, the USDA and the FDA updated their 28 April food safety position to include poultry, reflecting contaminated feed being fed to chickens in Indiana.
Risks to human health from this mode of entering the human food supply have been said to be low according to a number of FDA, CDC
Centers for Disease Control and Prevention
The Centers for Disease Control and Prevention are a United States federal agency under the Department of Health and Human Services headquartered in Druid Hills, unincorporated DeKalb County, Georgia, in Greater Atlanta...
and university toxicologists, though it was acknowledged that how melamine had harmed cats and dogs "remains something of a mystery".
On 7 May 2007, the USDA and the FDA issued a joint press release reflecting the combined judgment of five federal agencies with regard to the risk to humans in consuming meat from animals fed feed contaminated with tainted pet food scraps, concluding: "There is very low risk to human health" in such cases involving pork and poultry. The risk assessment was conducted by scientists from FDA,the Food Safety and Inspection Service
Food Safety and Inspection Service
The Food Safety and Inspection Service , an agency of the United States Department of Agriculture , is the public health agency responsible for ensuring that the nation's commercial supply of meat, poultry, and egg products is safe, wholesome, and correctly labeled and packaged...
(FSIS) of USDA, Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
The Centers for Disease Control and Prevention are a United States federal agency under the Department of Health and Human Services headquartered in Druid Hills, unincorporated DeKalb County, Georgia, in Greater Atlanta...
(CDC), the Environmental Protection Agency
United States Environmental Protection Agency
The U.S. Environmental Protection Agency is an agency of the federal government of the United States charged with protecting human health and the environment, by writing and enforcing regulations based on laws passed by Congress...
(EPA), and U.S. Customs and Border Protection
U.S. Customs and Border Protection
U.S. Customs and Border Protection is a federal law enforcement agency of the United States Department of Homeland Security charged with regulating and facilitating international trade, collecting import duties, and enforcing U.S. regulations, including trade, customs and immigration. CBP is the...
: "In the most extreme risk assessment scenario, when scientists assumed that all the solid food a person consumes in an entire day was contaminated with melamine at the levels observed in animals fed contaminated feed, the potential exposure was about 2,500 times lower than the dose considered safe" using criteria established prior to current research focusing on the apparent increased toxity related to the interaction of melamine and cyanuric acid in vivo for which there is no established safe dosage. FDA and USDA are in the process of identifying a group of experts to convene a scientific advisory board that would be charged with reviewing the risk assessment and contributing to future scientific analysis related to the risk of melamine and its compounds to humans and animals.
On 8 May 2007, some fish intended for human consumption was also announced as having consumed feed contaminated with tainted pet food scraps. According to the Assistant Commissioner for Food Safety of the FDA, "We do not believe that there is any significant risk associated with consuming these fish." Though the FDA declined to identify the states involved in the recall, the Oregon Department of Fish and Wildlife said contaminated fish feed had been found at the Marion Forks Hatchery. They also said that the company that provided the feed, Skretting, had shipped the same lot of feed to six other hatcheries in Oregon.
On 10 May 2007, on further inquiry into the risk to animal and human health of ingesting melamine and cyanuric acid in combination, Dr. David Acheson, Assistant Commissioner for Food Protection with the FDA said: "I'm not aware of any published studies on that. I have seen some preliminary data that would indicate that they are additive
Food additive
Food additives are substances added to food to preserve flavor or enhance its taste and appearance.Some additives have been used for centuries; for example, preserving food by pickling , salting, as with bacon, preserving sweets or using sulfur dioxide as in some wines...
. When you put the two together, they are additive rather than synergistic.... The risk assessors also estimated that even if synergism were to occur, it would be unlikely to result in more than a tenfold increase in overall toxicity, and that still gives you a very large margin of safety." No data supporting additivity was produced at this time. No basis for estimating a tenfold increase in risk in the case of synergism was offered.
On 15 May 2007, USDA announced that swine that ate melamine-tainted food have been cleared for human consumption. About 56,000 pigs have been affected in several states. However, no tests have been carried out on the effects of cyanuric acid in pork as well as possible effects of interaction with melamine in the body. While the statement also said that there is no evidence of bioaccumulation
Bioaccumulation
Bioaccumulation refers to the accumulation of substances, such as pesticides, or other organic chemicals in an organism. Bioaccumulation occurs when an organism absorbs a toxic substance at a rate greater than that at which the substance is lost...
of melamine alone, no mention was made whether bioaccumulation might be affected by the interaction of melamine and cyanuric acid in vivo particularly in swine kidneys.
On 3 October 2008 (updated 28 November 2008), in response to FDA learning that melamine might be contained in infant formula manufactured by a firm in China, FDA updated its 2007 interim risk assessment: "Infants may be more sensitive than adults to exposures because, for example, infant formula is the sole source of nutrition, exposure continues for up to 12 months, and renal function may be more immature compared to adults. This raises a high degree of uncertainty with regard to the determination of safety/risk. ... Therefore, if 100% of the diet were contaminated at a level of 1.26 ppm of melamine, an infant’s daily intake would equal 0.063 mg/kg bw/d. This value of 1.26 ppm is rounded down to 1.0 ppm melamine to provide an additional margin of safety."
FDA detains Chinese imports without examination
On 27 April 2007, the FDA subjected all vegetable proteins imported from China, intended for human or animal consumption, to detention without physical examination, including: Wheat Gluten, Rice Gluten, Rice Protein, Rice Protein Concentrate, Corn Gluten, Corn Gluten Meal, Corn By-Products, Soy Protein, Soy Gluten, Proteins (includes amino acids and protein hydrosylates), and Mung Bean Protein.These ingredients are used in such diverse products as breakfast cereal, pizza dough, baby formula, and protein shakes although at the time, there is "no evidence" that any contaminated ingredients have been used to produce human foods, according to Dr. David Acheson, chief medical officer at the FDA's Center for Food Safety and Applied Nutrition.
FDA requests monitoring by Centers for Disease Control
In addition to now testing a wide variety of imported food products and ingredients for melamine contamination, FDA has also "asked the Centers for Disease Control and PreventionCenters for Disease Control and Prevention
The Centers for Disease Control and Prevention are a United States federal agency under the Department of Health and Human Services headquartered in Druid Hills, unincorporated DeKalb County, Georgia, in Greater Atlanta...
to use its surveillance network to monitor for signs of human illness, such as increased renal failure, that could indicate contamination of the human food supply."
On 2 May 2007, Bernadette Burden, a CDC spokeswoman, was reported as saying that a CDC survey of poison control centers, veterans’ hospitals and a sample of private hospitals had found no increase in reports of kidney diseases.
U.S. federal testing methods
The Food Safety and Inspection ServiceFood Safety and Inspection Service
The Food Safety and Inspection Service , an agency of the United States Department of Agriculture , is the public health agency responsible for ensuring that the nation's commercial supply of meat, poultry, and egg products is safe, wholesome, and correctly labeled and packaged...
(FSIS) of the United States Department of Agriculture
United States Department of Agriculture
The United States Department of Agriculture is the United States federal executive department responsible for developing and executing U.S. federal government policy on farming, agriculture, and food...
(USDA) provides a test method for analyzing cyromazine and melamine in animal tissues in its Chemistry Laboratory Guidebook which "contains test methods used by FSIS Laboratories to support the Agency's inspection program, ensuring that meat, poultry, and egg products are safe, wholesome and accurately labeled."
On 24 April 2007, Stephen Sundlof, director of the FDA's Center for Veterinary Medicine, told reporters: "We have found cyanuric acid. It is somewhat related to melamine. Another compound that is very high in nitrogen and we are testing for that compound as well."
On 7 May 2007, the FDA sent a letter to food manufacturers, to remind them "of their legal responsibility to ensure that all ingredients used in their products are safe for human consumption." The FDA has made available to food manufacturers a procedure providing a general guide for the sample preparation and analysis of wheat gluten and pet food matrices for melamine using gas chromatography/mass spectrometry, the same methodology used by the FERN
FERN
FERN is a Dutch foundation created in 1995. It is an international non-governmental organization to keep track of the EU’s involvement in forests and to co-ordinate NGO activities at the European level...
laboratories.
On 15 May 2007, the process for testing meat from swine was validated by USDA's Food Safety and Inspection Service
Food Safety and Inspection Service
The Food Safety and Inspection Service , an agency of the United States Department of Agriculture , is the public health agency responsible for ensuring that the nation's commercial supply of meat, poultry, and egg products is safe, wholesome, and correctly labeled and packaged...
(FSIS).
Human food supply outside of U.S.
Media reports have raised the possibility that melamine may be widely used as an ingredient in human food products in China. According to a report from the Chinese Ministry of Health, 294,000 infants had been affected by melamine-contaminated infant formula by the end of November 2008. More than 50,000 infants have been hospitalized, and six deaths have been confirmed. Because of the large potential health impact, the World HealthOrganization (WHO) and the Food and Agriculture Organization of the United
Nations (FAO) convened an Expert Meeting.
Reports of melamine-contaminated product in Europe included, in October, 2008, when shops in Britain recalled chocolate erotic spreads from Chinese manufacturer "Le Bang" due to melamine contamination in excess of 100x the legal limit.
Official EC statements
On 7 June 2007 (updated 4 July 2007), the European Food Safety AuthorityEuropean Food Safety Authority
The European Food Safety Authority is an agency of the European Union that provides independent scientific advice and communication on existing and emerging risks associated with the food chain, created by European Regulation 178/2002....
(EFSA), in EFSA's Provisional Statement on a Request from the European Commission Related to Melamine and Structurally Related Compounds such as Cyanuric acid in Protein-rich Ingredients Used for Food and Feed, concluded: "EFSA provisionally recommends to apply a TDI of 0.5 mg/kg b.w. for the total of melamine and its analogues .... A source of uncertainty is the combined toxicity of melamine and cyanuric acid and their possible synergistic effects in relation to the recently observed toxicity linked to the acute renal failure and death of pet animals (cats and dogs) in the U.S. This mechanism is currently under investigation."
On 21 June 2007, The Health & Consumer Protection Directorate-General of the European Commission
European Commission
The European Commission is the executive body of the European Union. The body is responsible for proposing legislation, implementing decisions, upholding the Union's treaties and the general day-to-day running of the Union....
(EC) in reporting the Summary Minutes of the Meeting of the Standing Committee on the Food Chain and Animal Health (7 June & 8) acknowledged that corn gluten contaminated with melamine and rice protein concentrate contaminated with melamine and related compounds, both originating firom China, had been intercepted in Poland and Greece, respectively. The minutes further directed that "in case food producing animals have been fed with feed contaminated with melamine and related compounds, there is for the purpose of protecting human health, taking into account the conclusions of the EFSA statement, no need to take restrictive measures as regards the animals which have been fed with contaminated feed and as regards food of animal origin originating from animals fed with contaminated feed."
On 25 September 2008, EFSA issued a press release in response to reports of contaminated milk powder from China which stated, in part: "Children with a mean consumption of biscuits, milk toffee and chocolate made with such milk powder would also not exceed the TDI. However, in worst case scenarios with the highest level of contamination, children with high daily consumption of milk toffee, chocolate or biscuits containing high levels of milk powder would exceed the TDI. Children who consume both such biscuits and chocolate could potentially exceed the TDI by up to more than three times."
Impact on human pharmaceutical supply
In August 2009 the United States Food and Drug Administration advised pharmaceutical manufacturers that they should determine if they are using components possibly contaminated with melamine and test those components at risk, as well as make sure they get certifications from suppliers that at-risk components have been tested appropriately. A new guidance lists 27 components the agency considers to be at risk of melamine contamination based on its search of U.S. Pharmacopeia/National Formulary monographs and its Inactive Ingredient Database. The list — which includes adenine, ammonium salts, gelatin, guar gum, lactose, povidone and taurine — is not all-inclusive, the guidance says. "For the purpose of this guidance, we use the term at-risk component to mean those ingredients or raw materials that rely on a test for nitrogen content for their identity or purity or strength, and that contain nitrogen in amounts greater than 2.5 percent."Chinese government
Xuzhou
Xuzhou , otherwise known as Pengcheng in ancient times, is a major city in and the fourth largest prefecture-level city of Jiangsu province, People's Republic of China...
, Jiangsu, China
People's Republic of China
China , officially the People's Republic of China , is the most populous country in the world, with over 1.3 billion citizens. Located in East Asia, the country covers approximately 9.6 million square kilometres...
between 29 November and 8 March. ChemNutra says the gluten came directly from China or from China through the Netherlands
Netherlands
The Netherlands is a constituent country of the Kingdom of the Netherlands, located mainly in North-West Europe and with several islands in the Caribbean. Mainland Netherlands borders the North Sea to the north and west, Belgium to the south, and Germany to the east, and shares maritime borders...
, and that it received no reports of contamination in the chemical analysis provided by Xuzhou Anying Biologic Technology Development Company. The products were shipped from the company's Kansas City
Kansas City, Missouri
Kansas City, Missouri is the largest city in the U.S. state of Missouri and is the anchor city of the Kansas City Metropolitan Area, the second largest metropolitan area in Missouri. It encompasses in parts of Jackson, Clay, Cass, and Platte counties...
warehouse to several pet food makers and one distributor of pet food ingredients in the US and Canada, including the companies affected by the recall. Xuzhou Anying also exports carrots, garlic, ginger, corn protein powder, vegetables and feed.
On 5 April 2007, several days after the United States halted all wheat gluten imports, the Chinese government
Government of the People's Republic of China
All power within the government of the People's Republic of China is divided among three bodies: the People's Republic of China, State Council, and the People's Liberation Army . This article is concerned with the formal structure of the state, its departments and their responsibilities...
categorically denied any connection to the North American food poisonings to the New York Times, claiming they had no record of exporting any agricultural products that could have tainted the recalled pet foods, including the wheat gluten that has been the focus of the investigation. The general manager of the Xuzhou Anying Biologic Technology Development Company also denied that they had exported any wheat gluten to North America
North America
North America is a continent wholly within the Northern Hemisphere and almost wholly within the Western Hemisphere. It is also considered a northern subcontinent of the Americas...
.
However, on 6 April 2007, the Chinese government told the Associated Press
Associated Press
The Associated Press is an American news agency. The AP is a cooperative owned by its contributing newspapers, radio and television stations in the United States, which both contribute stories to the AP and use material written by its staff journalists...
they would investigate the source of the wheat gluten. Although the government refused to give details on the investigation, the Xinhua News Agency
Xinhua News Agency
The Xinhua News Agency is the official press agency of the government of the People's Republic of China and the biggest center for collecting information and press conferences in the PRC. It is the largest news agency in the PRC, ahead of the China News Service...
stated that "sampling and examination" of wheat gluten was under way across China, centering on the presence of melamine. Officials with office of the General Administration of Quality Supervision, Inspection and Quarantine, said that they will stay in touch with the U.S. Embassy in Beijing
Beijing
Beijing , also known as Peking , is the capital of the People's Republic of China and one of the most populous cities in the world, with a population of 19,612,368 as of 2010. The city is the country's political, cultural, and educational center, and home to the headquarters for most of China's...
and that "further measures would be taken based on developments in the United States."
Starting on 4 April 2007, the Chinese government refused US FDA requests to inspect facilities suspected of producing contaminated products. On 11 April, the director of the FDA's field investigations division said he was disappointed with the Chinese response. On 23 April, after refusing for nearly a month, China finally gave permission to FDA investigators to enter the country.
On 25 April 2007, Chinese authorities shut down Binzhou Futian Biology Technology Co. Ltd., and detained the manager, Tian Feng. Feng has denied responsibility, saying that he "didn't do anything wrong," and denying that he even knew what melamine was. The following day, China's Foreign Ministry said it has banned the use of melamine in food products, admitting that products containing melamine had cleared customs while continuing to dispute the role of melamine in causing pet deaths. China also vowed to cooperate with U.S. investigators to find the "real cause" of pet deaths. China provided a transcript of the 26 April press conference indicating that an invitation to FDA investigators had been sent on 23 April, but making no mention of banning melamine usage.
On 3 May 2007, Chinese authorities detained Mao Lijun, general manager of the Xuzhou Anying Biologic Technology Development, one of the companies accused of exporting contaminated protein, on unspecified charges, perhaps showing that the Chinese government is taking additional steps in its own investigations and signaling cooperation with US FDA investigators who arrived in China on Monday.
On 9 May 2007, Chinese authorities took a number of steps to address food safety
Food safety
Food safety is a scientific discipline describing handling, preparation, and storage of food in ways that prevent foodborne illness. This includes a number of routines that should be followed to avoid potentially severe health hazards....
concerns.
On 29 May 2007, in actions not linked directly to the protein export scandal, Xinhua reported that Zheng Xiaoyu
Zheng Xiaoyu
Zheng Xiaoyu was director of the State Food and Drug Administration of the People's Republic of China. He was sentenced to death in the first instance trial at Beijing No.1 Intermediate Court on May 29, 2007...
(郑筱萸), the former head of China's ministry of food and drug safety, had been convicted of personally approving unproven and unsafe medicines after taking bribes from eight pharmaceutical companies totaling more than 6.49 million RMB
Renminbi
The Renminbi is the official currency of the People's Republic of China . Renminbi is legal tender in mainland China, but not in Hong Kong or Macau. It is issued by the People's Bank of China, the monetary authority of the PRC...
, (or a rough equivalent of 850,000 US dollars), which resulted in at least hundreds of patient deaths, or perhaps even thousands, and as a result, he was sentenced to death. It was also discovered during his eight year reign as the head of China's ministry of food and drug safety, Zheng Xiaoyu had personally ordered the approval of more than 150,000 new medicines, an astonishing average of 134 times that of FDA, which only approves 140 or so new medicines annually. Not surprisingly, most of those 150,000 medicines were the products of the eight pharmaceutical companies that bribed Zheng Xiaoyu, and a single unsafe medication of Anhui
Anhui
Anhui is a province in the People's Republic of China. Located in eastern China across the basins of the Yangtze River and the Huai River, it borders Jiangsu to the east, Zhejiang to the southeast, Jiangxi to the south, Hubei to the southwest, Henan to the northwest, and Shandong for a tiny...
Hua Yuan (华源) Company (since closed with its CEO committed suicide before his arrest) resulted 14 patient deaths and hundreds being permanently disabled. Zheng Xiaoyu's former deputy was also convicted, for accepting more than two million RMB (or a rough equivalent of a quarter million US dollars) to help Zheng Xiaoyu. The former deputy was sentenced to a two year delayed death sentence and a new system for unsafe food recall would be implemented by the end of the year. However, the general public sentiment in China was that this was only the tip of the iceberg, because in the case of Zheng Xiaoyu, the exact amount of the bribe is much higher than what has been revealed so far, and this is confirmed by Zheng Xiaoyu's own confession: in March 2007, Zheng Xiaoyu admitted that the exact amount might never be known for sure because the 6.49 million was only what he accepted, and his wife and son also accepted separate huge bribes which he was not part of, and the investigation on Zheng Xiaoyu's family is still on-going. The Chinese public also believes that as the investigation deepens, the number of confirmed patients who died or were disabled would certainly increase.
In August 2007, Xinhua reported on a number of steps China had recently taken to ensure food safety and product quality, including instituting new product recall and customer notification systems.
In 2008, a number of steps were taken in China in response to the 2008 Chinese milk scandal
2008 Chinese milk scandal
The 2008 Chinese milk scandal was a food safety incident in the People's Republic of China, involving milk and infant formula, and other food materials and components, adulterated with melamine....
. A September 25, 2008 article from Xinhua is provided here as a link into some of the "Lessons Learned": "Sanlu, the center of the scandal, provided a bad example of crisis management. When it was first exposed, Sanlu refused to take the blame and passed the buck to innocent dairy farmers, which ignited great anger nationwide. A further official investigation showed Sanlu had lied about its contaminated baby formula for months while thousands of infants got sick and at least three died. Sanlu didn't openly admit its products were toxic until Sept. 11. It eventually recalled baby formula manufactured on and before Aug. 6."
Federal government
All of the food recalls executed by companies in the United StatesUnited States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
and Canada
Canada
Canada is a North American country consisting of ten provinces and three territories. Located in the northern part of the continent, it extends from the Atlantic Ocean in the east to the Pacific Ocean in the west, and northward into the Arctic Ocean...
were voluntary, i.e. not mandated by any government agency. In the United States, prior to the recall, the Food and Drug Administration did not keep pet foods under the same level of protection and safety ensurance as food intended for human consumption. According to the FDA, the FDA's "regulation of pet food is similar to that for other animal feeds. The Federal Food, Drug, and Cosmetic Act (FFDCA) requires that pet foods, like human foods, be pure and wholesome, safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled." However, "there is no requirement that pet food products have premarket approval by FDA."
Once the recall was announced, the Food and Drug Administration immediately began to mobilize resources to assist in the investigation. The FDA has dedicated each of its 20 district offices and three field laboratories to the investigation and more than "400 employees are involved in sample pet food collection, monitoring of recall effectiveness, and preparing consumer complaint reports." The FDA has activated its Emergency Operations Center, making sure the information on the poisoning gets to scientists and inspection teams. The agency "is also working with its regulatory partners in all 50 state agriculture and health agencies to inform them of the status of the investigative and analytical efforts." The FDA issued an alert to its field personnel that they should block import of wheat gluten from Xuzhou Anying Biologic Technology Development Company Ltd., and subject wheat gluten from China and the Netherlands to increased scrutiny.
As a result of the contamination, consumers and pets' rights groups have called for the FDA to take a more active role in ensuring pet food safety. On 2 April 2007, People for the Ethical Treatment of Animals
People for the Ethical Treatment of Animals
People for the Ethical Treatment of Animals is an American animal rights organization based in Norfolk, Virginia, and led by Ingrid Newkirk, its international president. A non-profit corporation with 300 employees and two million members and supporters, it claims to be the largest animal rights...
called for the resignation of the FDA’s commissioner, Dr. Andrew von Eschenbach
Andrew von Eschenbach
Andrew C. von Eschenbach was the Commissioner of the United States Food and Drug Administration from 2006–2009. He became acting Commissioner on September 26, 2005, after the resignation of his predecessor Lester Crawford, and was confirmed as Commissioner by the Senate on December 7, 2006...
. http://www.peta.org/pdfs/IGCFax.pdf
Possibly in response to growing concern about ensuring the safety of the U.S. food supply, on 1 May 2007, Dr. von Eschenbach announced the creation of an Assistant Commissioner for Food Protection to advise on "strategic and substantive food safety and food defense matters." Dr. David Acheson will fill this roll. According to Dr. von Eschenbach, "The protection of America's food supply and therefore the safety of Americans eating food of domestic or international origin is of utmost importance to me as a physician, and to the mission of this agency."
U.S. Congress
In the aftermath of the recall, there was a call from consumers for an investigation into Menu Foods reaction to the poisonings, and the federal government's stand on pet food safety and quality control and the FDA's response to the recall. On 1 April 2007, Senator Dick Durbin (D
Democratic Party (United States)
The Democratic Party is one of two major contemporary political parties in the United States, along with the Republican Party. The party's socially liberal and progressive platform is largely considered center-left in the U.S. political spectrum. The party has the lengthiest record of continuous...
- Illinois
Illinois
Illinois is the fifth-most populous state of the United States of America, and is often noted for being a microcosm of the entire country. With Chicago in the northeast, small industrial cities and great agricultural productivity in central and northern Illinois, and natural resources like coal,...
) called on the FDA to "account for weak links in the pet food inspection system." Earlier in the week, Representative Rosa DeLauro
Rosa DeLauro
Rosa L. DeLauro is the U.S. Representative for , serving since 1991. She is a member of the Democratic Party.The district is based in New Haven, and includes most of that city's suburbs.-Early life, education and career:...
(D
Democratic Party (United States)
The Democratic Party is one of two major contemporary political parties in the United States, along with the Republican Party. The party's socially liberal and progressive platform is largely considered center-left in the U.S. political spectrum. The party has the lengthiest record of continuous...
- Connecticut
Connecticut
Connecticut is a state in the New England region of the northeastern United States. It is bordered by Rhode Island to the east, Massachusetts to the north, and the state of New York to the west and the south .Connecticut is named for the Connecticut River, the major U.S. river that approximately...
) asked for an analysis of the FDA's oversight of pet food manufacturing facilities and a report of actions taken since the recall.
On 6 April 2007, Senator Durbin criticized the federal inspection process for both human and pet food and called for the hearings on the matter. According to the Los Angeles Times
Los Angeles Times
The Los Angeles Times is a daily newspaper published in Los Angeles, California, since 1881. It was the second-largest metropolitan newspaper in circulation in the United States in 2008 and the fourth most widely distributed newspaper in the country....
who interviewed Durbin 8 April, Durbin said he would like to see the FDA set national standards and inspection rules for pet food manufacturing facilities, and to see "federal law changed to allow the FDA to order a recall of food intended for human or pet consumption rather than rely on companies to do it voluntarily."
Durbin is working with Senator Herb Kohl
Herb Kohl
Herbert H. "Herb" Kohl is the senior U.S. Senator from Wisconsin and a member of the Democratic Party. He is also a philanthropist and the owner of the Milwaukee Bucks National Basketball Association team...
(D
Democratic Party (United States)
The Democratic Party is one of two major contemporary political parties in the United States, along with the Republican Party. The party's socially liberal and progressive platform is largely considered center-left in the U.S. political spectrum. The party has the lengthiest record of continuous...
- Wisconsin
Wisconsin
Wisconsin is a U.S. state located in the north-central United States and is part of the Midwest. It is bordered by Minnesota to the west, Iowa to the southwest, Illinois to the south, Lake Michigan to the east, Michigan to the northeast, and Lake Superior to the north. Wisconsin's capital is...
), the Chairman of the United States Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies. Senator Kohl initiated hearings in the Senate Appropriations Subcommittee along with Senator Durbin and Senator Bob Bennett (R
Republican Party (United States)
The Republican Party is one of the two major contemporary political parties in the United States, along with the Democratic Party. Founded by anti-slavery expansion activists in 1854, it is often called the GOP . The party's platform generally reflects American conservatism in the U.S...
- Utah
Utah
Utah is a state in the Western United States. It was the 45th state to join the Union, on January 4, 1896. Approximately 80% of Utah's 2,763,885 people live along the Wasatch Front, centering on Salt Lake City. This leaves vast expanses of the state nearly uninhabited, making the population the...
). Senator Robert Byrd
Robert Byrd
Robert Carlyle Byrd was a United States Senator from West Virginia. A member of the Democratic Party, Byrd served as a U.S. Representative from 1953 until 1959 and as a U.S. Senator from 1959 to 2010...
(D
Democratic Party (United States)
The Democratic Party is one of two major contemporary political parties in the United States, along with the Republican Party. The party's socially liberal and progressive platform is largely considered center-left in the U.S. political spectrum. The party has the lengthiest record of continuous...
- West Virginia
West Virginia
West Virginia is a state in the Appalachian and Southeastern regions of the United States, bordered by Virginia to the southeast, Kentucky to the southwest, Ohio to the northwest, Pennsylvania to the northeast and Maryland to the east...
), from the United States Senate Committee on Appropriations
United States Senate Committee on Appropriations
The United States Senate Committee on Appropriations is a standing committee of the United States Senate. It has jurisdiction over all discretionary spending legislation in the Senate....
was there as well. Witnesses included FDA officials. They looked into several areas: the delay in reporting by Menu Foods, the lack of federal inspections of pet food facilities, and incomplete reporting by the FDA since the start of the recall.
During the hearing Senators Durbin and Byrd criticized the government's response during the recall. Durbin specifically criticized the lack of any regular inspection practices or quality control with regards to pet food safety. Senator Kohl criticized the FDA's communication to the public about recalled foods, noting that volunteer websites had more detailed and easier-to-access information about the extent of the problem and which specific foods are of concern than FDA's online resources which Kohl said was contradictory of itself at times, and which the FDA official giving testimony admitted to being difficult to navigate.
On 18 April 2007, Senator Durbin and Representative DeLauro met with US FDA Commissioner von Eschenbach to discuss the additional rice protein recalls and learned that the Chinese government was blocking outside attempts to investigate the contamination. In response, they sent a letter to Zhou Wenzong, China's Ambassador to the United States saying in part that "contaminated batches of wheat gluten and rice protein responsible for these events were imported from China" and that "no level of melamine should be found in pet or human food" and asking for visas for inspectors from the United States.
Public
The protein export scandal inspired a significant amount of US media attention to Chinese food safety concerns, and increased unease about Chinese imports amongst the American public. A July 2007 Consumer ReportsConsumer Reports
Consumer Reports is an American magazine published monthly by Consumers Union since 1936. It publishes reviews and comparisons of consumer products and services based on reporting and results from its in-house testing laboratory. It also publishes cleaning and general buying guides...
poll found that 92 percent of Americans favored "country of origin" labeling on meat products, while in a USA Today
USA Today
USA Today is a national American daily newspaper published by the Gannett Company. It was founded by Al Neuharth. The newspaper vies with The Wall Street Journal for the position of having the widest circulation of any newspaper in the United States, something it previously held since 2003...
/Gallup poll, 74 percent of US respondents said they were "somewhat concerned" or "very concerned" about the safety of food imported from China.
See also
- 2007 pet food recalls2007 pet food recallsThe 2007 pet food recalls comprise the contamination and wide recall of many brands of cat and dog foods beginning in March 2007, and the ensuing developments involving the human food supply. The recalls in North America, Europe, and South Africa came in response to reports of renal failure in pets...
- 2007 Chinese export recalls2007 Chinese export recallsIn 2007 a series of product recalls and import bans were imposed by the product safety institutions of the United States, Canada, the European Union, Australia and New Zealand against products manufactured in and exported from the mainland of the People's Republic of China because of numerous...
- 2008 Chinese milk scandal2008 Chinese milk scandalThe 2008 Chinese milk scandal was a food safety incident in the People's Republic of China, involving milk and infant formula, and other food materials and components, adulterated with melamine....
- International Reaction to the 2008 Dairy Scandal
- Food safety in the People's Republic of ChinaFood safety in the People's Republic of ChinaFood safety in the People's Republic of China is a growing concern relating to agriculture. China's principal crops are rice, corn, wheat, soybeans, and cotton in addition to apples and other fruits and vegetables. China's principal livestock products include pork, beef, dairy, and eggs...