Globalization, New Regulations and Dietary Guidelines Increase Testing Requirements
The food sector in the United States (US) is experiencing its biggest changes in decades. This year, Congress passed the Food Safety Modernization Act, updating regulations first implemented in 1938. The act greatly expands the powers of the Food and Drug Administration (FDA), whose new clout now includes food recall authority. Also in 2011, the Dietary Guidelines for Americans, which are revised every five years, were updated to push for healthier diets overall, and especially for children. The guidelines target obesity now, and have already earned kudos for declines in some cancer incidences; folic acid enhancements during pregnancy; heightened awareness of the value of dietary fiber; and the eschewal of dietary trans fats, saturated fats and cholesterol.
To be sure, both the new act and the guidelines have been on the drawing board for some time, and food laboratories of all stripes have been gearing up for them. But having time is only a part of the advantage. Food labs have benefited from renewed vigilance following high-profile food contamination cases—melamine in pet foods and salmonella in peanut butter, among others, in the recent past, and the current radiation concerns about Japanese foods. Another major advantage stems from investments in advanced instrumentation, such as mass spectrometers, which significantly enhance analytical capabilities and productivity.
“Melamine had a large impact on the food industry, not just government agencies, because it was global in scale and generated a great deal of publicity,” says Antonietta Gledhill, Market Development Manager, Food and Environment with Waters Corporation. She notes that this focused the attention of the food industry on fitness-for-purpose of analytical methods, because the melamine scandal occurred as a result of the tests employed to assess protein content being open to manipulation. Many in the food industry are now employing more advanced technologies to detect this type of fraud.
Dr. Paul Young, a former European food regulator, and now Director, Chemical Analysis Operations with Waters, spends considerable time assessing and speaking on food safety regulations globally, and especially in China, India and Japan. “Most countries have revised their food safety regulations in the past ten years. Until January 4 [of] this year, the US labored under a 1938 law, so this has really been a long time coming.” Young explains that US food safety requirements require less testing than in Europe, for example, and were less stringent than for pharmaceuticals. The new law has the potential to usher in substantial changes, he says.
Paul Zavitsanos, Worldwide Food Segment Manager at Agilent Technologies, says that the new regulation empowers the FDA to deal with the likely effects of the globalization of the US food supply. He explains that the US has had substantially different food safety requirements compared with Europe and other parts of the world— largely because of safety controls at the point of production in the US.
According to Zavitsanos, the US controlled food safety through agricultural modernization procedures, and benefited from large-scale production and enhanced safety procedures at its mega farms. “The United States Department of Agriculture (USDA) also had the vision to invest heavily in agriculture modernization that stressed quality control standards throughout the production process. As a result, we did not have to test heavily at the end, because safety was controlled during production.”
On the other hand, in Europe, there were many small farms and myriad regulations, especially before the European Union (EU) was formed. “That generated an environment where there was testing for safety at the end as opposed to producing in a safe manner. The result was two different environments—sophisticated testing systems in Europe and sophisticated agricultural processes and education in the US.”
With globalization of the US food supply, however, that no longer applies, says Zavitsanos. He says it is impossible to control factors such as pesticides and water quality used in food production worldwide. “Post globalization, a lot of the controls went away, and we had to adopt the European testing paradigm. Now there’s a lot more testing in the US, as opposed to reliance on agricultural controls,” he says.
One reason is that it is difficult to differentiate between foods originating in the US and overseas. “Both raw materials and finished products are sourced from sites outside of the US agricultural system. As a result, there is a need for verification, testing and certificates of analysis like in Europe—this has been happening in the US over the past five to seven years, maybe more,” he says.
Young acknowledges the stellar role of the USDA in the US, but points to budgetary concerns. “The USDA, whilst not subject to the new law, does operate surveillance and testing programs under its Food Safety Inspection Service (FSIS),” he says. The department has been the subject of substantial budget cuts, however, especially for research that supports monitoring. “The new law has the potential for increased vigilance, but the budget isn’t matching that,” says Young.
Despite the inherent challenges, the new regulations have been greeted with considerable good will and optimism. Gerry Broski, Food Science Marketing Director for Thermo Fisher Scientific, says, “The new developments set standards that will help the reputation of the food industry as a whole. There’s broad agreement about the act. There are questions over how all the requirements will be funded in light of current budget cuts—everything I see suggests that they will be funded.”
Broski says that the increased testing and traceability, certification of testing labs, and the overall harmonization of global food testing practices are net positives that will help ensure the quality and safety of our foods.
Implications for food labs
“Within the new US food safety law, there is a complete section on controlling the safety of imported foods. The US really has its options open—retaining the ability to work collaboratively with competent authorities and the right to audit current systems and foreign supplier verification systems,” says Young.
“This law, as structured, has potential for both collaborative and inspectional approaches. The FDA must carry out in the first year alone 600 overseas inspections of facilities, and will double that number every year. Five years from now, we are looking at about 20,000 overseas facility inspections,” says Young.
He cautions that an inspectional approach alone will not be sufficient given the volume of food imported in the United States. “There needs to be more collaboration, such as the International Food Safety Training Laboratory established jointly by the University of Maryland and the FDA —the Joint Institute of Safety and Applied Nutrition (JISAN). The facility will be dedicated to food safety and provide training to foreign scientists,” he says. Waters Corporation has important collaborative functions with the facility.
Zavitsanos says that these developments will translate into great increases in contract research, research expenditure, method development and analytical procedure development. “We have already started seeing heavier demand for and more emphasis on mass spectrometry for the development of new and more sensitive and rapid confirmatory techniques. The confidence and speed of the methodologies were increasing.” He expects that workload would be pushed not to the FDA but to contract labs servicing the secondary and primary food industries.
There will be greater use of ICPMS and ICP-OES for trace metals analysis. In addition, more use will be made of novel techniques for emerging contaminants like persistent organic pollutants such as dioxins, PCBs, dioxin-like PCBs, and PBHs, which were prevalent in the Gulf of Mexico during the recent oil spill. In the near future, there will be steppedup efforts in the analysis of emerging contaminants, according to Zavitsanos. There will be stepped-up research efforts to catch the next melamine— that is, unknown and unexpected contaminants that could affect the food supply, he says. “There will be considerable expansion in the testing capacity of the private contract lab infrastructure in food safety testing, both in the chemical and biological areas,” he says. He notes that even in Europe, which currently does much more testing than the US, no more than one percent of the testing is done by states—all the rest is conducted by contract labs. “This is becoming a worldwide trend now— China has made some important shifts toward contract testing as well.”
Zavitsanos says the number of food labs worldwide is increasing, and the established facilities are boosting their capacity. He says that with the reduction of contract testing in the pharmaceutical sector, a number of contract labs are turning to food testing. As a result, there is greater demand for instrumentation, especially premier tools like GCMS and LC-MS and triple quad instruments. Like Waters’ Young, he too points to a shift away from older techniques to mass spectrometric techniques in food safety specifically. He says that obtaining results rapidly is essential now—it is not enough to identify bacteria—it is important to rapidly trace them back to their source to mitigate further outbreaks and spreading.
“Another major issue now is the measurement of allergens, such as peanut, shellfish and gluten in foodstuffs. The idea is to measure precisely to determine whether they were in an ingredient incorporated into a product or they were processed in a facility that may have contaminated them indirectly,” he says.
Young does not envisage whole new lines of instrumentation and technologies emerging in response to the new guidelines, because what is required is already in place. “I suspect that any changes or improvements would have happened anyway. Producers are constantly trying to improve the quality and efficiency of their products—I often see legislation following industry efforts.”
“Quality control labs are typically associated with more core detector instrument types, whereas food safety labs are characterized by hightech, time-of-flight types of analyses for accurate mass measurements and broad purpose readings. R&D labs use high-end instrumentation, such as tandem quadrupole GC-MS-MS or high-resolution time-of-flight.”
Young says that there is a visible migration toward high-end instrumentation, not only for food safety, but also for routine nutrient analysis. “We see a number of quality control labs, especially those involved with infant formulas and vitamins, moving to mass spectrometry and away from core detector systems. The mass spectrometry systems enable them to work more effectively—they can consolidate processes, and instead of having one method for one vitamin, they can have several vitamins in one method. This increases productivity, accuracy and precision.”
The food lab in a major food company
Unlike many food companies and the global trend, Hormel Foods does most of its laboratory work in-house. Its primary research facility has a little over 100 employees, with the staff equally divided between new product development and quality and safety. “Some of our subsidiaries may contract out their microbiology work because of time constraints. We handle about 250,000 different product samples over the course of a year. Included among those are about 300,000 microbiological assays and 550,000 chemical assays,” says Phil Minerich, VP for R&D. Hormel’s worldwide operations include two plants in China, one each in Beijing and Shanghai, and joint ventures in South Korea, the Philippines, Vietnam, Australia, Denmark, England and Central America.
The R&D side develops dozens of new products every year. “Product development scientists access the sensory methods for qualitative descriptive analyses to describe attributes of different foods. That is a specific skill set based on the ability to determine better taste, color and other attributes. We also use the chemical and microbiology labs to formulate products from a nutritional and functional perspective, and also to validate processes and food safety interventions,” he says.
Addressing the impact of the Food Safety Modernization Act on their processes, Minerich says, “A lot of our primary products are FSIS controlled. So, we are kind of a step ahead of what came in the modernization act.”
“Most of our products are USDA based, and our labs have updated equipment, methodologies, and the required proficiency and efficiency to properly analyze these samples. As the act was unfolding, we worked with the GMA, AMI and other organizations to understand how to make the transition,” says Rick Christianson, Group Manager of Lab Services.
This is more likely to relate to us through our ingredients suppliers, says Christianson. “After the melamine and Salmonella incidents, we reviewed all our supplier arrangements and validations. We rely on our ingredient manufacturers—so in the last five or six years we have drastically reduced suppliers we work with, particularly those that provide more than 90 percent of our ingredients. Our relationship with them has become much stronger through validations, interventions, environmental monitoring, auditing and the certificates of analysis they provide us. We better understand their methodologies, and QC conducts site visits and our own or third-party audits through the Global Food Safety Initiative (GFSI),” he says.
With respect to the dietary guidelines, Minerich says, “In our health and wellness initiatives, we are looking at a number of ways to develop healthy products—with low fat, low sodium, moderated calories, portion control, higher fiber and other key attributes.”
He says, “I thought the 2010 guidelines were presented quite well. They were extremely neutral in terms of not turning it into a good food/bad food scenario. It was about portion control, balanced diets—meats, fish and different protein sources. It focused on cutting calories and exercise, and was based on common sense. A number of interest groups target and demonize certain foods for one reason or another—so I really applaud the FDA for applying neutral ideas like portion size and calorie counting.”
He says that requirements such as those around trans fats have not been a large problem for the protein-based industry. “At Hormel, we do have some fryers with tortilla shells and we have a few products where oils would be a concern, but we switch those oils out to eliminate trans fats. The fat industry has really been cooperative in that initiative; they have modified their chemistry so that trans fats have been virtually eliminated from the retail market.”
Turning to the centrality of the food lab in their operations, Christianson says, “The labs help all our processes—whether through formulation, nutritional analysis, sensory analysis, shelf-life determination, validation of food safety interventions, or the use of less or different kinds of energy, water recycling, verifying the potability of the water we use, or in efficacy of water treatment. These are the host of ways that the lab provides sound scientific support to our initiatives.”
Hormel’s Christiansen says that in the food industry, competitor companies often work together on safety issues. “Food safety is not a competitive issue—we work together as a whole scientific community to address these issues,” he says.
That bodes well for the future, and Agilent’s Zavitsanos concurs, “In the US and Europe, the quality of the food supply will continue to be safe, and will get safer. It will be protected against a wider range of contaminants, both chemical and biological. The possibility that you will encounter a contaminated product will go down.
“This is against the backdrop that the amounts of imported food are going up every year. In China and India, there will be dramatic increases in food safety both for export products and for domestic consumption—both countries have domestic food safety testing laws and they are building an infrastructure for domestic and export testing.
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Bernard Tulsiis a freelance writer based in Newark, Del. He may be contacted at firstname.lastname@example.org or 302-266-6420.