[International regulations] High Risk and Nano-particulates

International Regulations Continue to Tighten

Today international food contamination incidents are front-page news, such as the 2008 melamine-contaminated milk scandal in China. Melamine elevated the awareness of the global nature of food, underscoring the importance of complete documentation and traceability back to origin. Less obvious are the many areas of increased regulatory attention on higher risk residues such as mycotoxins, and nanoparticles, whose risks are less well understood.

As a result of the melamine contamination incidents, China is developing a three-year plan to solve its food safety issues, said Yolanda Fintschenko, manager for Food Safety Technologies, Thermo Fisher Scientific. And, she added, she expects to see China’s food safety standards tightening across the continent and its MRLs becoming more consistent with global standards.

Though not generally front-page news, mycotoxins and aflatoxins have been topics of international regulation and forums for more than 40 years. U.S. regulation began in 1968 with a focus on the concentration of the mycotoxins in food and feed after related animal and human health incidents. By the mid-2000s more than 100 countries had mycotoxin regulations.

The European Union (EU), a long-time global leader in food safety, has already placed a heavy emphasis on mycotoxins analysis. In the United States, the FDA has regulatory authority over mycotoxins, for which it has established specific “action” levels for aflatoxin present in food or feed and “advisory” levels for other mycotoxins. At the international level, the Codex Alimentarius Commission of the United Nations (Codex) has set advisory standards on natural and environmental toxins such as mycotoxins. However, these standards are advisory, not mandatory, and national standards vary widely. Most countries recognize the prudence of placing standards on the level of mycotoxins entering the food chain, but diverging perceptions of how to balance economic costs and health benefits can cause a great deal of trade friction between countries.

Japan has responded to consumer demand for food producers and distributers to show scientifically sound evidence that the food they pay a premium for, such as eels, are truly from Japan and not a country that would fetch a cheaper price, such as China.

Worldwide regulatory agencies are trying to understand the health risks of nanoparticles in the food chain. This can include antimicrobials such as nanocolloidal gold or nanotechnology used as food ingredients. The complications with nanoparticle studies is that they are difficult to measure. Fintschenko explained. “What is the effect of having this particle in the 10- to 100-nanometer size?” Does it increase the exposure, or decrease it, or does size not matter? In addition, because of its nano-size, it is very difficult to both accurately measure size and determine the composition of the particle in an efficient manner. EPA has recognized this as an emerging issue, she added, and is looking at the question primarily in relation to antimicrobials and pesticides.

Depending on the findings of the groups, facilities may have to add processes to measure and test for nanoparticles and protect food and workers.

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Mycotoxins and their Global impact

The Definition. Mycotoxins are toxic secondary metabolites of fungi. Naturally occurring chemical compounds, they can be produced on a wide range of agricultural commodities and under a diverse range of situations worldwide.

The Problem. The ability of molds to grow in many foods is due to their versatile environmental requirements. Most mycotoxins are stable compounds that are not destroyed during food processing or home cooking. Even though the generating organisms may not survive food preparation, the preformed toxin may still be present. Certain foodborne molds and yeasts may also elicit allergic reactions or cause infections.

The Health Threat. The accumulation of mycotoxins in foods and feeds represents a major threat to human and animal health as they are responsible for many different toxicities including the induction of cancer, mutagenicity and estrogenic gastrointestinal, urogenital, vascular, kidney and nervous disorders. Some mycotoxins are also immuno-compromising, and can thus reduce resistance to infectious disease.

The Economic Impact. Able to invade and grow on virtually any type of food at any time, mycotoxins cause varying degrees of deterioration and decomposition of foods. They invade crops in fields before harvest and during storage, and can grow on processed foods and food mixtures. It is estimated that 25 percent of the world's food crops are affected by mycotoxin-producing fungi, with global loss estimated at 1,000 million tons per year. Thus, there is an ongoing need to protect human and animal health by limiting exposure to mycotoxins.

The Global Issue. Despite years of research, and the introduction of good practices along the food chain, mycotoxins continue to be a problem. Since the mid-2000s, more than 100 countries have regulated for, or suggested permitted levels of, mycotoxins in foods and feed because of their public health significance and commercial impact. However, as with many food safety regulations, most mycotoxin standards focus on the product, rather than the process. That is, tolerance levels for the amount of mycotoxin in a product are established rather than regulating the production or treatment of the commodity along the supply chain.

In addition, trade disputes that are common with standardizing of mycotoxin regulations are likely to persist because mycotoxin contamination is recognized as an unavoidable risk; perceptions of tolerable health risks are not likely to narrow significantly in the near future; and countries may set precautionary standards which lack internationally accepted risk assessments.
Compiled from FDA, USDA & FAO reports.

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Melamine adulteration in food is a tragedy and a watershed event in that it was a widespread and deliberate food contamination issue, said Gerry Broski, Marketing Director for the Thermo Fisher Scientific Food Safety Program. The situation has, however, spurred greater public awareness and several proactive initiatives. “Consumers around the world are realizing that food safety doesn’t come for free, and for producers, the good news is that consumers seem to be willing to pay for assured safety and quality,” Broski said. “Retailers and producers have been promoting the need for higher safety and quality as evidenced by the addition of a ‘Food Safety Manager’ within their organizations.”

In addition, Broski said, “President Obama has stated that science will play a key role in the future of America. Many different entities are converging on the fact that food safety is science, it’s complex, and cannot be taken for granted – it is an area of public safety that requires greater resources and innovative approaches.” 

From the milk and pet food contaminations, the industry also learned that adulterated product was able to move through the supply chain to the consumer because everyone thought someone else was doing the testing, Fintschenko said. “If everyone starts doing more testing and taking more ownership, food should become safer.” This is also enhanced by the drive to develop applications through which the scientific and laboratory tools further food safety efforts and pro-actively address the next threat or regulation.

And such lessons are widespread around the globe, according to Fintschenko, who says, “People have really become engaged in trying to further food safety.”

June 2009
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