Thursday, October 16, 2008

Melamine Contamination Poses Global Threat

Melamine contamination of Chinese milk is posing a global threat prompting countries to impose bans and further casting a shadow on the safety of Chinese food exports. Although you’ve heard “melamine” in the media, you may not know what it is. Melamine is a chemical compound used in the production of laminates, glues, dinnerware, adhesives, molding compounds, coatings and flame retardants. Although melamine is the term used both for a chemical and for the plastic made from it, all references in the food contamination threat are to the chemical. Because melamine is high in nitrogen, adding it to food artificially increases the apparent protein content as measured with standard tests. It is important to know that there is no approved melamine use in direct addition to human or animal food in the U.S. As recently as October 1, 2008, reports indicated there have been over 53,000 illnesses, nearly 13,000 hospitalizations,100 seriously ill cases and at least four infant deaths in China. Approximately 158 of the victims thus far have suffered acute kidney failure.

Source of the Contamination

In 2007, melamine was found in pet feed manufactured in China and exported to the U.S. which caused the death of a large number of dogs and cats due to kidney failure. It is unknown when melamine contamination first resulted in human illness. However, in March 2008, Chinese manufacturer Sanlu received a complaint of illness. In early September 2008, Chinese media reported that Sanlu brand infant formula produced by Hebei-based Sanlu Group was contaminated with melamine. Sanlu's powdered infant formula is widely consumed by infants across China because the product is relatively affordable.

Chinese authorities have disclosed that, in addition to discovering contaminated infant formulas, melamine has been discovered in 24 of 1202 samples of milk and yogurt. There is little information at this stage to determine how widespread the contamination might be. However, Chinese authorities report that melamine was found in infant formula, milk, yogurt, and ice cream manufactured by 22 companies in China. There are a total of 175 infant formula manufacturers across China, of which 66 have halted production and the remaining 109 manufacturers have undergone inspection.

Chinese government officials have pinpointed milk collecting stations as the sites where the melamine was added. Tests have also found melamine in 24 batches of liquid milk produced by three of China’s best known dairy firms. Sanlu reported that contaminated milk was used in the manufacture of powdered infant formula processed before August 6, 2008. The raw milk used to produce powdered baby formula had been watered down, and the chemical melamine was added to fool quality checks. The scandal was worsened by an apparent cover-up by companies involved and the ignoring by safety officials of tips and warnings from parents and doctors. Top Sanlu executives and government officials in the northern city of Shijiazhuang, where the company is based, have been forced to resign.

Products Affected and Recalls

The FDA reports that melamine contamination has been found in liquid milk, frozen yogurt dessert, biscuits, candy, and coffee. All these products were most probably manufactured using ingredients made from melamine contaminated milk. The FDA is advising consumers not to consume the following products because of possible melamine contamination: Blue Cat Flavored Drinks, White Rabbit Candies, certain varieties of Mr. Brown Instant Coffee, Mr. Brown Milk Tea, and all infant formula manufactured in China.

On October 10, HUA XIA Food Trade USA, Inc. based in Flushing, N.Y., issued a recall for YILI Brand Sour Milk Drink packaged in 250ml flexible paperboard boxes and YILI Brand Pure Milk Drink packaged in 250ml flexible paperboard boxes because it may be contaminated with melamine. These YILI products were distributed to New York City through Asian retail grocery stores. The recall was initiated after FDA testing discovered that the product was found to contain melamine.

Recently, Hong Kong's food safety agency said its tests have found melamine in a Japanese brand's Chinese-made cheesecake. Moreover, a sample of Lotte Cream Cheese Cake manufactured by Japan's Lotte China Foods Co. Ltd in mainland China was found to contain melamine. Hong Kong and Macau authorities earlier detected excessive melamine in Lotte's popular Koala's March chocolate and strawberry cream cookies. In September, British confectioner Cadbury recalled all of its Beijing-made candy products over fears that they may be contaminated with the chemical melamine.

FDA Efforts to Protect American Consumers

On September 12, 2008, in light of reports from China of infant formula contaminated with melamine, the FDA issued an advisory to reassure Americans that there is no known threat of contamination in infant formula manufactured by companies authorized to sell in the U.S. That advisory also warns members of Asian communities in the U.S. that infant formula manufactured in China, possibly available for purchase at Asian markets, could pose a risk to infants. According to the FDA, no Chinese manufacturers of infant formula are authorized to sell infant formula in the U.S.

In addition, companies that manufacture infant formula for distribution in the U.S. have reported to the FDA that they do not import formula and do not source milk-based ingredients from China. The FDA – in conjunction with state and local officials – continues to check Asian markets for food items that are imported from China and that could contain a significant amount of milk or milk proteins. The FDA has broadened its domestic and import sampling and testing of milk-derived ingredients as well as finished food products containing milk or milk-derived ingredients from Chinese sources.

The sampling is being done either when products are offered for entry into the U.S. or at the retail level. In addition to working with state and local governments, FDA is working in close cooperation with Customs and Border Protection within the U.S. Department of Homeland Security, the U.S. Department of Agriculture, other federal agencies, and foreign governments.

FDA’s Advice to Importers and U.S. Food Manufacturers

The FDA recently issued a “Dear College Letter” to importers and U.S. food manufacturers advising how to protect against melamine contamination. The letter indicated that for food manufactured in the last twelve months which might still be on retail shelves or in stock elsewhere, the supplier should determine whether the food might contain any milk-derived ingredients from China. Moreover, the FDA advised that importers and manufacturers know the precise origin of each milk-derived ingredient and to determine that milk-derived ingredients originating from China are free of melamine and its analogues prior to usage. Furthermore, the letter advised that manufacturers should be alert to the possibility that non-milk-derived ingredients from China that are or may be sold on the basis of protein content, such as soy protein, also could be contaminated with melamine. To issue a recall for any product due to the presence of melamine, firms should follow the FDA guidelines in 21 CFR Part 7 Subpart C as well as communicate with the local FDA district office.

Importers and manufacturers can test for the presence of melamine using a gas chromatography-mass spectrometry (GC-MS) as well as a liquid chromatograph-tandem mass spectrometry (LC-MS/MS). More information is available at the FDA website. FDA Field laboratories are using LC-MS/MS methods that are capable of determining melamine and cyanuric acid at levels of 0.25 ppm (parts per million) in powdered infant formula and other dairy-containing food products or ingredients.

Measuring the Risk Level of Melamine Tainted Products

The FDA conducted an interim safety/risk assessment to identify the level of melamine and melamine-related compounds in food which would not raise public health concerns. For infant formula, the assessment concluded that currently FDA is unable to establish any level of melamine and melamine-related compounds in infant formula that does not raise public health concerns. Largely, this is due to gaps in our scientific knowledge. In food products other than infant formula, the safety/risk assessment concludes that levels of melamine and melamine-related compounds below 2.5 ppm do not raise public health concerns. According to the State Council of China, the levels found in the batches ranged between 0.09 mg/kg and 619 mg/kg. Batches from the company Shijiangzhuang Sanlu Co. contained the highest levels, up to 2563 mg/kg. (Note: parts per million are the same as mg/kg. Since mg/kg = 0.001/1000 = 0.000001 = 1/1,000,000 = ppm).

Detention of Products Without Physical Examination

The FDA has issued an import alert to announce the detention without physical examination (DWPE) of certain food products due to the presence of melamine. The agency’s authority for such action is found in the Federal Food, Drug and Cosmetics Act. The FDA may refuse import admission pursuant to Section 801(a)(3) for adulterated foods under the meaning of section 402(a)(2)(C)(i), for foods that contain poisonous or deleterious substance which may render it injurious to health under section 402(a)(1) and appear unfit for food under section 402(a)(3).

To secure release of an individual shipment subject to the import alert, the importer is required to provide the results of a third-party laboratory analysis of a representative sample of the lot verifying that it does not contain melamine or melamine analogs. To remove a firm from detention without physical examination, information should be provided to FDA to adequately demonstrate that the manufacturer has resolved the conditions that gave rise to the appearance of the violation, so that the agency will have confidence that future entries will be in compliance. Requests for removal from DWPE should be directed to FDA's Division of Import Operations and Policy.

Melamine Threat Results in Global Bans

The scandal has sparked global concern about Chinese food imports, with more than 30 countries restricting Chinese dairy products, and in some cases all Chinese food imports. In addition to the recalls announced by the FDA, other countries have all identified products containing melamine including flavored milks, cakes, candies, crackers, rice snacks, coffee creamer, lactoferrin, and cereal. Milk and milk products that could originate from China include condensed, dried, and non-fat milk, condensed and dried whey, lactose powder, permeate powder, demineralized and partially demineralized whey powders, caseins, yogurt, ice cream, cheese, whey protein concentrate, and milk protein concentrate.

In Vietnam, authorities established inspection teams to test milk products while India's Health Ministry imposed a three-month ban on the import of Chinese milk and milk products. In South Korea, the government banned the importation of all Chinese products containing milk after Chinese biscuits tainted with melamine were discovered. Meanwhile, health officials in Singapore and Indonesia announced additional recalls of products made with the contaminated milk. Products pulled from store shelves range from flavored milks and ice creams to cookies and candies. Authorities in a variety of places have stopped importing some Chinese products made from milk including Indonesia, Taiwan, Japan, Singapore, Malaysia, Burundi, Gabon, Tanzania, Brunei and the Philippines. In late September, Taiwan announced Monday it was banning the importation of all dairy products from China because of melamine contamination in milk supplies on the mainland, Taiwan's Health Ministry said Monday. On September 25, 2008, the European Union announced a ban on imports of baby food containing Chinese milk. In addition to the ban, the European Commission called for tighter checks on other Chinese food imports.

Chinese Action to Curb Melamine Threat

On October 10, China's State Council tightened quality control regulations for the dairy industry. The new regulations, effective immediately, tighten control over cattle breeding, the purchase of raw milk and the production and sale of dairy products, the official Xinhua News Agency said. The measures also increase punishments for those caught violating safety standards.

Chinese police have arrested 40 people in the tainted-milk scandal, including 22 in northern China's Hebei province. Nineteen of those were managers of pastures, breeding farms and milk-purchasing stations, the Xinhua news agency reported, citing a panel investigating the case. Authorities say they raided 41 locations in Hebei and seized 490 pounds (222 kilograms) of melamine. Eighteen arrests were announced earlier. They include two brothers who face charges of selling contaminated milk. The brothers could face death if convicted, according to China Daily, a state-run newspaper.

Police in northern Hebei province arrested a suspect accused of producing 600 tons of melamine-spiked protein powder, Xinhua said. Eight dairy farm owners and milk buyers were also arrested purchasing the powder. Chinese government investigations finding 37 Chinese dairy companies, including the most reputable brands, had sold tainted products. Police have arrested 36 people in connection with the scandal in Hebei, where Sanlu is headquartered.

The head of China's quality watchdog is reported to have resigned over the scandal. Li Changjiang had quit with the approval of China's State Council. Li's agency is responsible for ensuring that China's food supply chain is safe. Monday's resignation came hours after the World Health Organization said the scandal had highlighted flaws in the country's entire food supply chain.

Melamine Product Liability Cases Pending in China

In late September, one lawyer reported that the Beijing Judicial Bureau asked Beijing lawyers not to accept problematic milk powder-related cases. Other Beijing lawyers told the Associated Press they had not come under any pressure to reject such cases. Parents of an 11-month-old diagnosed with kidney stones filed a lawsuit against the Sanlu Group Co. - the dairy company at the heart of the tainted milk crisis. It is the second known lawsuit against the company. Earlier in September, parents from central Henan province filed suit against Sanlu, seeking $22,000 in compensation for medical, travel and other expenses incurred after their 14-month-old baby developed kidney stones. It is not clear if courts will allow these suits to progress as product liability lawsuits are still relatively rare in China, and lawyers have complained of government pressure to withdraw from the cases.

Global Scandal Affecting Chinese Milk Farmers

Yangjiazhai milk farmers in north China’s Hebei province say the collection center once supplied seven tons of milk a day to Sanlu. Operations ceased after Hu Shumin, the owner of the collection center, was arrested for allegedly selling four packets of the chemical melamine to a cow breeder for mixing into milk, but it was not clear if Hu was accused of using the chemical at his own collection center. Lacking buyers, the farmers are now forced to dump freshly pumped milk or peddle it to nearby villagers. And as uncertainties grow over the global scale of the crisis, others say they plan to sell their cows before further losses mount due to feed costs they can’t recoup.

[Thanks to Rosa Dunnegan for her assistance in preparing this article.]