Lessons learned from the melamine crisis
September 01, 2008
by World Grain Staff
In July 2007, the former head of China’s State Food and Drug Administration Administration, Zheng Xiaoyu, was executed for corruption after being convicted of taking bribes of more than $850,000.
His trial and death came in the wake of the discovery of shipments of wheat gluten and rice protein that contained deadly levels of an adulterant known as melamine, which killed nearly 200 animals and sickened thousands of others.
Since then, Chinese exports have been under increasing scrutiny from the U.S. Food and Drug Administration (FDA) and other regulatory authorities in the U.S. and abroad. The U.S. Department of Health Human Services and China’s State Food and Drug Administration have signed a memorandum of understanding to increase the level of vigilance in monitoring the food-trade supply chain.
In addition to the execution of Xiaoyu, Chinese authorities shut down 180 food manufacturers found to have used industrial chemicals in their products. And in the U.S., in the same month as Xiaoyu’s death, President George W. Bush formed the Interagency Working Group on Import Safety (IWG), charged with identifying ways to improve the systems intended to ensure the safety of products imported into the United States.
"This situation served as a catalyst for change because it brought to the forefront a problem that most people usually don’t consider: that’s substances — and individuals — which can contaminate the feed supply," said Daniel McChesney, a doctor at the Center for Veterinary Medicine’s Office of Surveillance and Compliance in Atlanta, Georgia, U.S.
Although scrutiny and vigilance have risen in regard to the safety and purity of materials in the feed grain supply chain between China and the U.S., the relationship between the two countries has not deteriorated, said Randall Gordon, spokesman for the National Feed Grain Association (NGFA). "Some of the materials that we import, we no longer make here," Gordon said. "Of course, our grain industries are very dependent on export shipments and those being accepted by other countries, so I don’t think the relationship has been damaged. In fact, I think both the U.S. and China are working together in good faith to strengthen and improve our trade relationship because of this incident."
On that note, during the fourth session of the U.S.-China Economic dialogue in Annapolis, Maryland, U.S. on June 18, U.S. Secretary of Health and Human Services (HHS) Mike Leavitt signed a Joint Progress Statement with Li Changjiang, minister of China’s General Administration of Quality Supervision, Inspection, and Quarantine. Among other things, this will allow the FDA to establish inspection offices in China and further cooperation between the two countries.
Richard Sellers, the American Feed Industry Association’s (AFIA) director of regulation and nutrition, said that three members of the association were under indictment for their involvement in the melamine crisis, and certain details about the case were difficult for him to comment on because of a pending trial. FDA’s office of criminal investigation, Sellers says, is working together with prosecutors in Kansas City, Missouri, U.S., to determine at what point these parties became aware of the contamination, and if the adulterant was deliberately or mistakenly added to the feed supply. "One scenario involves a criminal misdemeanor, the other involves a criminal felony," Sellers says. "We do not know the nature or level of the offenses that have been alleged, so it is difficult to comment on the case at this point."
The motive for alleged actions like this — deliberately contaminating the feed supply — is very clear to Mc-Chesney. "It was to gain an economic advantage," he said. "They made a very low quality product appear to be more valuable in terms of protein content but then were able to undersell competing products and gain a market edge."
These products were significantly cheaper than similar feeds in the U.S. and Europe, and that should have caused suspicion, McChesney said. "Sometimes if a deal looks too good, it is."
The U.S.Attorney’s Office for Western Missouri is charged with prosecuting the case since the port of Kansas City is the location where ChemNutra received the contaminated shipment. Along with Las Vegas food importer ChemNutra and its owners, Sally Qing Miller and Stephen Miller, prosecutors report that there are several other defendants charged with criminal misconduct which resulted in the 2007 pet food recall. Also charged in a 26-count indictment returned by a federal grand jury in Kansas City are:
• Xuzhou Anying Biologic Technology Development Co., LTD. (XAC), a Chinese processor of plant proteins that exports products to the U.S., along with its owner and manager, Mao Linzhun;
• Suzhou Textiles, Silk, Light Industrial Products, Arts and Crafts I/E Co., LTD. (SSC), a Chinese export broker that was used by XAC to export products to the U.S., and its president, Chen Zhen Hao.
A trial has been set for Nov. 3, 2008, according to Don Ledford, public affairs liaison for the U.S. Attorney’s office in Kansas City.
Prosecutors believe that the parties indicted intended to "defraud and mislead" by introducing falsely labeled food into interstate commerce. "The labeling of the food was false because the food was represented to have a minimum protein level of 75%, when it did not, and because the food labeled as wheat gluten contained two or more ingredients, including melamine. But melamine was not listed on the label," according to the indictment.
ChemNutra and the Millers also face 13 misdemeanor charges for delivering adulterated food that contained melamine, "a deleterious substance that rendered the wheat gluten injurious to health, into interstate commerce." The food was also adulterated, prosecutors say, because melamine was substituted wholly or in part for the protein requirement of the wheat gluten. As McChesney suggested, this allowed the wheat gluten to appear to be of a greater value than it was. LESSONS LEARNED
Close to 15% of the U.S.’s food supply is imported. "This is a global market, and ingredients for manufacturing can be pieced together from many different places," McChesney said, adding that it can be extremely difficult at times to trace back inputs to their sources. Now, sources say that a new emphasis has been placed on traceability. Tyson Foods Inc. says this is the procedure for tracing the "history, application or location of that which is under consideration."
In the future, pet food manufacturers as well as feed lots will have to improve their traceability systems to document the history of a product and locate it in the process chain. Luckily, this crisis was primarily relegated to the pet food sector. But 56,000 hogs and close to 20 million broiler chickens slated for human consumption were also quarantined as a result of the recalls in March 2007. Overruns of certain products, in addition to off-spec materials not suitable for pets, are often sold into the feed sector. "But after the FDA investigated, the risk was found to be negligible that those animals would have been contaminated for human consumption," Sellers says. "Because this feed usually has animal matter in it, it cannot be fed to cows because of the BSE rule…so cattle weren’t affected."
The FDA was overwhelmed during this period, receiving almost three times their annual number of complaints in only a couple of months. "Recalls usually involve only one or two companies. The melamine recall, however, involved thousands of products and upwards of 100 companies, so all the stakeholders have had to work together to solve the problem," McChesney said. "We’ve had to consolidate our response because we found that affected consumers wanted all the information in one place."
In addition, the FDA is also looking at ways to improve how information is coming into the agency. "We’re working more intimately with veterinary hospitals because they are often the closest to a problem as it is happening," he said.
Working together has been a theme for industry and government in response to the melamine crisis. Therefore, the AFIA, NGFA, National Oilseed Processors Association, National Renderers Association and the Pet Food Institute presented a "guidance for industry" to the FDA in March of 2008. "The segment addressed, selecting ingredient suppliers, was directly related to recent adulteration events in our collective industries," stated a letter sent to Bernadette Dunham, director of the Center for Veterinary Medicine, in Rockville, Maryland, U.S., accompanying a draft of the guidance for industry. "We believe this document provides FDA the basis for providing to the industry at large its "current thinking" on ingredient supplier selection and only that topic."
Officials say that adulterants in the animal food supply can be introduced through manufacturing processes, during transport or many other variables. Guidance documents advise manufacturing firms to "consider visiting one or more of a potential supplier’s facilities to assess its process controls and product safety" as well as procuring representative samples for independent testing. "Distributors need to know their suppliers very well and develop relationships with them," McChesney said. "You’re putting yourself at risk by dealing with parties you’re unfamiliar with."
The next step is to select a certified laboratory by evaluating the testing methodology, quality programs and repeatability of results at the facility that may impact accuracy. "Many of the protocols outlined in the guidance for industry were in place before the recall," Sellers said. "But now they have been presented in one place."
At the plant level, personnel should refer to the facility’s established standard operating procedures for regular or interval testing of a sample for adulterants based on the firm’s sampling and analytical protocols. "When medicated feeds are made, they can be mixed at the wrong concentrations. In fact, most of the problems that we see are unintentional," McChesney said. "The key is to have more than one person involved in the process, and if a mistake is caught it should be corrected in the early stages of production."
Plant personnel should be wary of ingredients that signal significant concerns, including differing color, odor, texture, extraneous material, consistency and handling properties that may be an indicator of potential adulterants.
Nicholas Zeman is a correspondent for World Grain and Biofuels Business magazines. He can be reached at firstname.lastname@example.org.
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