A Bigger Role for the Food Lab of the Future

A series of food safety crises, including melamine contamination in pet foods; E coli-tainted spinach, peppers and green onions; and a Salmonella typhimurium outbreak in peanut products have transformed food analysts from vigilant sentries into veritable centurions stridently safeguarding the quality, regulatory compliance and safety of our food.

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A series of food safety crises, including melamine contamination in pet foods; E coli-tainted spinach, peppers and green onions; and a Salmonella typhimurium outbreak in peanut products—linked to nine deaths and 637 illnesses in 44 states and Canada—have transformed food analysts from vigilant sentries into veritable centurions stridently safeguarding the quality, regulatory compliance and safety of our food.

Common sources of food contamination include antibiotics, accumulated pesticide residues, pathogens, and pollutants in soil and water. But unwanted impurities may enter at any stage between production and consumption. Increasing global trade adds more concern, particularly when foods originate in places that still use chemicals banned in the importing country and where detection and monitoring are less robust.

The consumption of unsafe food may impact health, thereby capturing public attention. But while food safety is a primary function, food labs have broader responsibilities, such as monitoring overall quality, including freshness, taste, and nutrient and calorific content, as well as physical characteristics such as texture and crispiness. They also assess fats and sugars in food and the suitability of packaging materials, among other analyses.

Food labs have state-of-the-art tools for sample preparation; physical, chemical and biological analyses; and data management. Some also have organoleptic capabilities—the use of sensory organs to evaluate appearance, odor, flavor and mouth feel.

Food labs also guard against counterfeiting— for example, passing off lowerquality olive oil as extra virgin, different strains of rice as the prized basmati, or farm-raised salmon for wild Pacific salmon. In general, such economic interferences cheat consumers by delivering an inferior product at a higher price. Sometimes, however, the results of such adulterations are disastrous, such as the unscrupulous addition of melamine to artificially inflate protein content measurements in baby food in China and pet food in the United States.

Legislation

To be sure, these challenges have not gone unnoticed, and a more vigilant regulatory climate has emerged as a result. In the United States, the Bioterrorism Act of 2002 and a presidential directive in 2004 mandated stricter monitoring of ingredient suppliers and manufacturing procedures. In early 2009, leaders of the House Energy and Commerce Committee introduced a bill, the Food and Drug Administration (FDA) Globalization Act, intended to increase the power of the FDA while strengthening regulations on imported drugs and food. The bill was first proposed in April 2008 by Rep. John Dingell of Michigan.

“The bill makes a lot of proposals that will impact the way food companies do business and the regulatory climate in which they operate,” says Martin Mitchell, managing director of Long Island, New York-based Certified Laboratory, a full-service, independent food-testing laboratory established in 1926.

“There appears to be almost universal agreement that the FDA is not doing a great job, and the goal is to figure out how to give the FDA enough money and authority to improve the process,” says Mitchell.

Alessandra Rasmussen, chromatography business director of PerkinElmer Life and Analytical Sciences, agrees that regulations are becoming stricter. “More pesticides are being added to the regulations list, and in Europe, about 22 to 30 are being evaluated for possible addition to the list.

“We are also seeing new regulations for known contaminants. One issue now is what level of melamine is ‘acceptable,’ a determination that is heavily dependent on the age of the person ingesting it,” says Rasmussen.

Mitchell says that an FDA study, which he describes as “an excellent assessment of the risk associated with melamine,” showed that human adults, not babies, were unaffected by melamine at concentrations of less than 250 parts per million.

“We are now being asked to find melamine in food down to 250 parts per billion, or 100 times lower than what is believed to be risky,” says Mitchell. “The question is, to what benefit?

“This drives the cost of analysis up, creates problems with trace contamination with no associated hazards—and generally makes the job more difficult.

“I think there will be a lot more intervention in the supply chain, but whether it will be done in the style of government control or in an industry-guided approach is still to be seen.

“Everyone agrees about wanting safe food, but there is great disagreement about how to accomplish it.”

Who pays?

Another key question revolves around who should pay for testing, says Gerry Broski, marketing director for food safety at Thermo Fisher. “Consumers assume that food is safe because it was tested, but, with increasing frequency, we are seeing that is not the case.

“The big question: Is testing a service or facility that the government provides, or is it the responsibility of the retailers or producers of the raw materials or the makers of the end product? Ultimately, who is responsible for testing?”

Also to be figured out are some enforcement issues. “When a company tests and the product turns out bad, how do you enforce that the product is not shipped?” asks Broski.

Lab settings

Today’s food analysts ply their trade mostly in at least one of three settings— in-house laboratories at raw material suppliers or food manufacturers, contract or third-party independent laboratories, and regulatory and compliance laboratories operated by governmental agencies such as the FDA. Several academic institutions also maintain impressive food laboratories for instructional and research purposes.

The in-house corporate laboratories of food producers and food product manufacturers occupy a central place in the food testing area. They focus acutely on the corporate business model, in which the goal is to produce safe, wholesome food for sale. These facilities are a part of the entire manufacturing process; in a way, they are not different from, say, accounting or marketing.

“In some cases, some manufacturers’ labs have grown substantially, have acquired some degree of independence and may even offer their services to other food companies,” says Yolanda Fintschenko, manager of food safety technologies at Thermo Fisher.

Essentially, there are two types of inhouse labs: R&D and QA/QC. In general, food companies and most tech-heavy companies conduct R&D in house in order to safeguard intellectual property, ensure that they develop new products before competitors do and maintain a marketing edge. To be sure, some R&D work is outsourced, but the companies maintain control because this is the major source of their competitive and economic advantages.

With the QC laboratories, competitive advantage is less of an issue, and the choice of in-house versus outsourcing is always cost-based. In addition to cost, the decision may be influenced by time constraints. In-house QC labs are highly suited to facilitate the production process— whereby a batch often cannot progress to the next level without analysis, and several tests done in quick succession may be required.

Contract or independent third-party laboratories generally handle the outsourced work from in-house labs. “The vast majority of our work is done for food manufacturers, importers, distributors and major fast-food chains,” says Mitchell.

The emergence of private/ contract labs

In the late ’70s to early ’80s, the FDA implemented “detention without physical examination,” reasoning that if action were taken only after detecting a noncompliant sample, certain shippers from some countries with a high percentage of failure rates would, in effect, be allowed to distribute noncompliant food in the United States. “That’s where the private labs came in to provide evidence that particular merchandise was fit and suitable for its intended use,” says Mitchell.

Even though many food companies have in-house laboratories, there are strategic reasons to use third-party services. “They rely on us for independence and specialized expertise. There are very few inhouse labs with the capabilities to test for melamine as well as to take on overflow work,” he says.

“Our food company clients may present the data we produce for them to regulatory agencies to establish compliance, but we do not work directly for the FDA or USDA,” says Mitchell.

“The most important distinction is our independence. We are third-party, and we have no connection to the outcome of our findings and no financial interest in the merchandise being tested,” says Mitchell. “Yes, we are science for hire, but our thirdparty status gives us independence.”

Certified Laboratory, like other private facilities, offers testing services spanning microbiology, challenge studies, validation studies, chemical analyses and artificial color analyses, among others. Its unique food forensics department serves the spice industry and some foreign food importers. It also offers organoleptic analysis for seafood. “We have several people on staff capable of smelling and grading seafood according to standards,” says Mitchell.

More samples to be tested

Paul Young, senior manager of chemical analysis operations at Waters Corporation, says that the different classes of laboratories have different requirements: “Manufacturers’ labs may require very high throughput. Instruments are required to have the appropriate sensitivity, but high throughput is important.”

This need could increase. Regulations are currently being developed in China that will require testing every single batch of infant formula. If a factory has several production lines, samples will be taken from each line and, at the minimum, during each shift.

The regulatory labs may not have so many samples to test, so throughput is not as important, according to Young. “They need to have the highest confidence in their results because they base key regulatory decisions—such as product recall or prosecutions—on them,” says Young, who recently joined Waters after serving as a food regulator in Europe.

Analysis tools and technologies

“Regulatory labs need to be absolutely certain that what they have identified is melamine, for example, and not another chemical that looks like it. As a result, regulators will often use two complementary techniques, whereas manufacturers may rely on a single method,” he says.

The French National Laboratory uses a very specific and selective gas chromatography- based method that can detect at about a tenth of the regulatory limit to screen for melamine in infant formula and dairy products. “If they find any presumptive positive results, they will follow up with another confirmatory technique, such as the UPLC with a tandem core detector,” says Young.

This approach makes perfect sense to Thermo Fisher’s Broski, who says, “We view government regulatory labs as the standard setters.”

The clock is ticking

A common factor among the different labs is the enormous time pressure under which they operate. This is seen in regulatory labs when dealing with a crisis. This is true for manufacturers’ labs also if a product is recalled and all raw materials have to be rechecked. “They need to work rapidly to assure customers about the quality of their brands,” says Fintschenko.

“There are many reasons a food producer lab is under the gun. In some cases, it may have to do less with safety than with deciding whether they are paying the right price for raw materials or answering questions about the flavor, texture and odor of food products or ingredients,” says Fintschenko.

“In the contract testing labs, the mission is to provide data, often to a food producer or manufacturer. Here, speed is of the essence, because until they provide the results, it may not be possible for the next step to occur,” she says.

One case in point is the alleged “lab shopping” by Peanut Corporation of America, a central player in the salmonella-tainted peanut products scandal. The plant’s inhouse labs in Blakely, Georgia, found salmonella strains in its products about a dozen times during the past two years, according to the FDA.

The company had the product retested, and after it obtained a negative salmonella status report, it decided to ship the product. Dubbing that “lab shopping,” Georgia’s agriculture commissioner, Tommy Irvin, says that the correct practice when a food product tests positive for salmonella and another test comes back negative is to accept and act on the basis of the positive test.

Despite the occasional setback, our food supply has been maintained at impressive quality and safety levels, largely because of the vigilance of food lab scientists and the array of instrumentation they use to prepare, test and measure samples.

Rasmussen says that in these tough economic times, food labs are keen to improve their productivity and efficiency, especially as they relate to their analytical capabilities.

“Contamination or recall has a huge financial impact on food companies; hence, they want to have the necessary watchdog systems to ensure that their final products are free of adulterants and contaminants,” says Rasmussen.

On the managerial side, she says that while there is an utmost need for the same level of performance, laboratories are looking for much greater ease of use. This means that less-trained personnel—not necessarily PhD-level chemists—should be able to run the equipment and get the required data. “This is especially true in areas of the food industry that are not so research-oriented but still need the right result for informed and critical results,” says Rasmussen.

Melamine detection tools

Melamine detection is one area that was attacked very vigorously by instrumentation manufacturers, and today a number of solutions have been offered by several major analytical instrumentation designers and manufacturers.

Melamine first came to light around March 2007, when the deaths of some pet cats and dogs in the United States were traced back to deliberate adulteration by some unscrupulous raw material suppliers in China.

When food is assessed, the protein content is usually analyzed as a mark of quality. The problem is that the Kjeldahl method that is used for this analysis is a measure of nitrogen content and not specific to protein at all. Melamine, a readily available by-product of plastic manufacturing, has high nitrogen content— so when it is added to food, if tests are not specifically for melamine (and none were a few years ago), then the melamine is, in effect, interpreted as protein.

When Waters designed its melamine analyzer, it did not fall into that trap, according to Young. “Now the vast majority of users will employ mass spectroscopy methods. We have just issued new instrumentation—the Acuity UPLC—for infant formula manufacturers, with very high throughput and short turnaround time.

“This system uses the PDA detector for greater sensitivity, allowing for detection below the regulatory requirements, which are technically 1 part per million for infant formula. The Acuity UPLC can detect validated levels at 50 parts per million (0.05 part per billion), so there is very high confidence in the results,” says Young.

Last year, PerkinElmer launched its melamine analyzer, which consists of the Clarus 600 T GC/MS with PSS injector and liquid autosampler, TurboMass GC/MS software, consumables, and a melamine application CD.

PerkinElmer’s Clarus 600T GC/MS melamine analyzer.

“Melamine is not a contaminant that was usually tested for, so a new method needed to be developed so that operators with varying skill sets could do the analysis using the FDA-approved GC/MS method,” says Rasmussen.

In collaboration with an independent testing lab, PerkinElmer scientists developed a method following the FDA guidelines, wrote the standard operating procedure for running melamine on the GC/MS and packaged it as part of the melamine analyzer, according to Rasmussen.

“This enabled customers to get up and running quickly on the method—it takes just about 1.5 hours from when the instrument is installed to when the customer can actually run the melamine analysis,” says Rasmussen.

Thermo Fisher’s Fintschenko says, “The newest product we have in food safety is the Exactive, which allows us to use exact mass for the identification of small molecules in the presence of interference.”

This is a competitively priced benchtop instrument that uses technology typically seen in proteomics. It is delivered in turnkey form, is easy to use and does not require special environments such as time of flight.

Future testing

“One of the biggest problems facing thought leaders in food safety right now is that most labs do targeted analysis—where they look for a fixed list of compounds. Melamine helped everyone realize what some thought leaders had already recognized—that you only find what you are looking for,” says Fintschenko.

“The need to have an exact mass screening tool that will allow you to find everything in food and then evaluate whether those things should be there or not is extremely important,” she says.

One of the ideas that forward thinkers have come up with to prevent a melamine-like scenario in the future is to do non-targeted screens. “There has been considerable thought around this already—melamine has just brought it more sharply into focus,” says Fintschenko.

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Investment Confidence

Published: April 1, 2009

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Investment Confidence

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