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Laboratories that analyze food are up against a unique set of circumstances quite unlike those of other industry laboratories. Not only must they be aware of external drivers, such as business issues and regulatory requirements, but they must also be highly focused on the quality of raw materials and end products.
The food industry is just one segment of a vast interlocking system that surrounds consumables processing. It is closely tied to agriculture on the front end and to packaging and waste management on the back end. The type of food being processed dictates the regulatory requirements and laboratory data reporting criteria. Depending on the product - from meats to seafood to dairy products to wine - the lab may be accountable to the US Food and Drug Administration (FDA), the US Environmental Protection Agency (EPA), the US Department of Agriculture (USDA), the Bureau of Alcohol, Tobacco, and Firearms (ATF), the Centers for Disease Control and Prevention (CDC), or the National Marine Fisheries Service (NMFS) (see sidebar). In all cases, quality control (QC) and quality assurance (QA) mandates driven by the various regulatory agencies play a significant role, particularly in the realm of safety, sanitation, packaging, and labeling.
More recently, the Nutritional Labeling and Education Act was signed into law in 1990. According to this legislation, food companies must provide more information about their products on the labels. It is estimated that implementing the new food label requirements will cost FDA-regulated food processors between $1.4 billion and $2.3 billion over the next twenty years. However, FDA calculates that the benefits to public health - measured in monetary terms - will significantly exceed the costs. These benefits include decreased rates of coronary heart disease, cancer, osteoporosis, obesity, high blood pressure, and allergic reactions to foods (2). Needless to say, this requirement has increased the amount of data that laboratories must generate to prove label information and verify product contents, and the workload in food laboratories has increased correspondingly.
On 3 August 1996, President Clinton signed the Food Quality Protection Act (FQPA) of 1996. This law amends the two major pesticide laws: the Federal Insecticide, Fungicide, and Rodenticide Act and the Federal Food, Drug, and Cosmetic Act. The FQPA establishes a new safety standard for pesticide residues in all foods and applies to raw and processed foods. Numerous factors in making risk assessments are considered part of the tolerance-setting procedure under the new law, and the additional data generated to support the accompanying methodology and results that will now be required ratchet the laboratory work load up another notch.
Not only is general legislation on the increase (see box above), but parallel activities that are taking place internationally will have a profound impact on how food laboratories manage lab data. For example, the Montreal Treaty Protocol, originally signed in 1987 and amended in 1990 and 1992, phased out by 2000 (2005 for methyl chloroform) the use of halogen-containing chemicals, such as chlorofluorohydrocarbons, that deplete ozone in the stratosphere. Because many of the solvents on the treaty's hit list are commonly used in extractions during the sample preparation part of analyses, many analytical techniques are affected. The use of laboratory instruments that require very little or no harmful solvents for extractions has been one outcome.
Legislation aside, increased competition combined with requirements for lower operating costs and greater lab data documentation are also driving the food industry toward a dramatic change in the use and application of technology.
QC testing requirements may include accurate measurement of chloride, nitrate, nitride, fluoride, iodide, and calcium in a variety of foods and beverages. Varying the sample temperature and background matrix is an approach often used to ensure accurate test results. In many production facilities, raw materials are tested shortly after they are received, and the end product is tested on the production line.
In the case of food additives and preservatives, several criteria may be examined (see sidebar: Table 1). Additives help keep foods safe to eat, improve nutritional value, and provide distinctive flavor and color. Preservatives can retard product spoilage caused by mold, air, bacteria, fungi, or yeast, thereby allowing many foods to be available year-round. To market a new additive, a manufacturer must first petition FDA for its approval. The petition must provide convincing evidence that the proposed additive performs as intended. In deciding whether to approve an additive, the agency considers the composition and properties of the substance, the amount likely to be consumed, probable long-term effects, and various safety factors. The manufacturer might provide FDA with an assortment of assays that quantify the nutritional composition, packaging interaction studies, and microbiological shelf-life test results.
Because the relationships among the chemical, physical, nutritional, and quality properties of foods are affected by formulation, processing, and packaging, a variety of analytical techniques and instrumentation are used. These techniques include gravimetric, volumetric, titrimetric, chromatographic, and spectrophotometric methods; and the analytical method of choice depends on the application.
It is important to keep in mind that just as more than one technique
can be used to analyze a food sample, different types of food
laboratories have dif
What is the worst thing that could happen to a food manufacturer? Food poisoning and contamination from unsanitary or unsafe manufacturing processes are at the top of the list. In 1995 there was an uproar over bovine spongiform encephalopathy, or "mad cow disease," that virtually brought the British beef industry to a standstill. Salmonella in chicken eggs and other products surfaces again and again. Even when chemicals such as Alar - which was pulled from the market in 1989 after the television program "60 Minutes" falsely called it "the most potent cancer-causing agent in our food supply" - are not at fault, the government may ban a product because of public outcry.
The latest crisis involves Escherichia coli contamination in Odwalla's (Half Moon Bay, CA) unpasteurized apple juice. On 31 October 1996, the US Department of Health and Human Services announced an E. coli contamination in Odwalla's (Half Moon Bay, CA) unpasteurized apple juice. On 31 October 1996, the US Department of Health and Human Services announced an E. coli 0157:H7 outbreak associated with Odwalla apple juice products. Odwalla was already cooperating with FDA in a voluntary recall of all its apple juice products and all blended juice products containing apple juice. The product was pulled from shelves in 4,600 retail outlets in seven Western states and British Columbia, Canada, less than two weeks after the first reported case of illness.
Odwalla makes a variety of 100 percent fresh specialty fruit and vegetable juices, capitalizing on the latest trend in healthful products with no artificial additives or preservatives. The company brings fresh fruits and vegetables from the trees and fields to be squeezed, pressed, blended, and then chilled and bottled at their 65,000 square-foot facility in Dinuba, CA. From this production facility, the product is kept in cold storage facilities during transport and at the stores that sell the product. Despite these precautions, E. coli was present.
FDA investigated Odwalla's recalled apple juice samples as well as the sourcing, production, and distribution processes in place at the company. After eleven days of testing, FDA did not find any E. coli at Odwalla's Dinuba plant, although it had previously found the bacteria in one unopened customer-returned bottle in Seattle, WA. However, the agency found numerous violations of guidelines at the plant, including apple washing in which the cleansing agent was too diluted. FDA officials have shifted the investigation to the growers and packers who supplied the apples. Given this shift, the problem is not just Odwalla's, but one that affects the entire industry.
The E. coli bacterium is elusive and challenging, because it continues to appear in food products previously thought to be inhospitable. Organic foods are often fertilized with cow manure, and E. coli flourishes in cattle. Experts speculate that the apples Odwalla used most likely became infected with the E. coli bacteria when they fell to the ground and came into contact with cow or deer feces in the orchard, or from fruit pickers who came in contact with fecal matter and spread it to the apples.
Pasteurization, the heating process that kills bacteria, would almost surely have prevented the outbreak. The use of growth-regulating chemicals such as Alar might also have forestalled the Odwalla poisoning. Alar prevents fruit from dropping off trees prematurely and thus keeps them off the ground and away from pests and fecal matter. The upshot is that, despite the fact that the problem appears to originate at the farms that grow the apples and not at Odwalla's processing facility, Odwalla made the difficult choice of implementing flash pasteurization, a process by which the juice is quickly heated to a high temperature that kills bacteria and then rapidly cooled so that the flavor is relatively unaffected.
While bacterial outbreaks are increasing, so is America's consumption of all-natural foods - an industry that has grown about 20 percent a year since 1990 and projects 1996 sales of $3.3 billion. The likelihood of new regulations, which could range from pasteurization to washing apples with some kind of disinfectant to forbidding the use of apples that have hit the ground, is high.
One of the world's leading food manufacturers, Nestlé (Vevey, Switzerland), has more than 450 facilities in seventy countries, with about 220,000 employees. Founded in 1866, the company has had more than a century to refine process techniques and accumulate product data. This is necessary because the company is so decentralized that only 2 percent of sales are generated in the headquarters country. Nevertheless, Nestlé has set industry standards for product quality. The only way to be absolutely confident of the results is by accurate monitoring and control of laboratory data.
According to Reinhold Kranzer, LIMS project manager at Nestlé Deutschland AG, "Every aspect of our business is dedicated to making products look and taste good and to meeting stringent manufacturing and regulatory requirements. Raw materials used in the production process determine the quality of the finished goods to a high degree. Therefore, it is imperative that we test all raw materials before allowing them to be used in our production process" (3).
At Nestlé's three production plants in Germany, laboratory data are managed with Hewlett-Packard's ChemLMS, an Oracle-based LIMS that operates within an open-systems environment. For consistency, all three labs use the same version of software. Each plant processes a different set of foods. The Singen plant near Lake Constance processes instant soups and sauces, canned soups, and other, similar products. The other two Nestlé facilities with LIMS are in Bavaria at Weiding and Biessenhofen, and they manufacture baby food and milk products such as condensed milk. All three labs do a wide range of analyses, including heavy metals, pesticides, radioactivity, and sensory testing. On average, the Singen site handles about 10,000 samples per year, testing 2-200 parameters for each raw material sample. Indeed, at least 60 percent of the samples at the Bavarian laboratories are tested for more than 200 parameters.
Samples must be analyzed shortly after the delivery of goods to the factory. The Singen lab, for example, tests all incoming raw materials such as tomatoes, eggs, and wheat. Deliveries are held in the warehouse and not released for production until the analytical results are received. Materials that do not comply with standards are returned to the vendor.
"Before implementing the LIMS, the entire process, from receiving materials through QC testing, was paper driven," Kranzer explained. "All necessary procedures were performed manually, including production of work lists, collection and centralization of results, and release of approved raw materials. The LIMS improved the process of QC by closing the loop for data and processes within a controlled system. The system not only provides a simplified verification process but also allows the laboratory to check exceptions or events and to track an audit trail. Now, our QC is exactly defined and used, with no gray areas remaining."
A subsidiary of the National Food Processing Association that provides services to the foods industry, the NFL addresses the needs of food manufacturers and processors, food ingredients, agricultural chemicals, and food-related packaging. More than fifty chemists and microbiologists do a variety of analyses on all types of samples, from raw ingredients to the finished product, using techniques ranging from GC and HPLC to GC/MS, UV-visible spectrophotometry, and AAS.
Because it is not a food producer, the NFL has no vested interest in any of the samples it analyzes. "Most food companies have their own research and development labs," explained Bradford Allen, a research chemist, "and much of the regulation in the industry is self-regulatory with respect to the quality of foods. However, because of downsizing and reengineering, there's more outsourcing of sample analysis to contract labs like ours. Many growers and food manufacturers have small sample volumes. It makes sense for them to outsource their sample analysis."
Since the E. coli contamination of Odwalla's apple juice products, the NFL has been assisting Odwalla with sample analysis. Samples are received from clients and are accompanied by a list of the required tests and turnaround time. Some clients send only one sample from every lot, but some send more, depending on the food product and the type of analysis to be run. Some clients require a twenty-four-hour turnaround if the sample is from a production environment.
Before 1991, the NFL used a paper-based system to track samples, tests, and results. However, "only a certain amount of information can be input and tracked manually," Allen pointed out. "We not only wanted to implement a LIMS, we wanted to upgrade our instruments to electronic control of data acquisition at the same time." Because the NFL's laboratory operations are organized by specialty - from nutrition to microbiology labs to the pilot proving plant - and because many samples are multidisciplinary and require analysis from several different units, data had to be accessible throughout the laboratories in a common, easy-to-use, and upgraded format. In addition, the NFL wanted to leverage its existing investment in PCs and workstations.
The key requirements for the LIMS narrowed down to a system that was PC-based, had a flexible report output, and was able to interface to a variety of instruments. The LIMS would need to provide sample tracking, offer immediate access to information about the status of the workload, and set workload priorities. The NFL selected Analytical Automation Specialists' (Baton Rouge, LA) LabWorks LIMS and recently upgraded the system from DOS to Windows 3.1. The new interface made sense because Windows was being used with other applications in the lab.
"Windows changed the data in the LIMS quite a bit," recalled Allen. "It's now much easier to export data into reports, databases, word processing programs, and the like." Allen particularly likes using a LIMS because results entry is now automatic, not manual, and he is much more productive as a result.
The food business is conservative and slower to change than many other industries, in part because it operates on very tight margins. There are not many LIMS in food laboratories because the labs are small, the testing profile is relatively simple, and many labs are just starting to move from a paper environment to PCs.
Even so, many food labs already enter information into stand-alone PCs. Placing the information from those PCs into a LIMS environment eliminates much manual data entry and significantly reduces the unnecessary duplication of data input as well as the potential for error. A LIMS can accept and organize sample information, assist in the automation of sample preparation, coordinate instrument analysis of the results, verify the results, generate appropriate reports, and store data for future retrieval. It also maintains electronic logbooks and an audit trail. Even better, LIMS can be integrated into the supervisory packages used to control production plant operations, providing timely information not just to the lab but also to administration and other business units.
Although the food industry has not been as highly regulated as others, such as the pharmaceutical industry, it is becoming more so. The intent of any new regulations will remain the same - ensuring adequate and uniform sanitary and QC measures - but the cost to implement additional measures will require many food manufacturers and processors to engage in some level of business process reengineering to control costs. Whether this means implementing a quality management system or automating processes and reducing head count, or both, remains to be seen.
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