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Making Food Safer Through Law and Technology
by Maybelle Cowan-Lincoln
The year 2013 was a big year for food safety in terms of advancements in testing, regulations, and equipment. Of course, food safety also made an impact across mainstream media headlines. One topic that proved most prevalent involved instances of food fraud—two men arrested in London as part of an investigation into beef adulterated with horsemeat; eight managers of the Toulouse, France-based company Spanghero, arrested for fraudulently supplying horsemeat labeled as beef to ready-made meal manufacturer Comigel; and over 900 people arrested in China for food safety violations, including 63 people who sold modified rat, mink, fox, and other meat as lamb. Food fraud, in the form of species misrepresentation, has become a global problem.
The issue here goes beyond deception. Animal species that are not destined to enter the food chain are not subject to the same safety standards as animals meant for human consumption. Their feed is not regulated and their meat not tested for pathogens. Also, veterinary medications can be an issue. For example, horses not raised for human consumption may have been given phenylbutazone, a substance linked to cancer in humans. The European Food Safety Authority and the European Medicines Authority pointed out in a 2013 joint statement that a maximum threshold for carcinogen risk could not be identified; therefore, the substance is banned in animals destined to enter the food chain.
Although media coverage has focused on cases of meat fraud in Europe and Asia, U.S. consumers cannot be complacent about the integrity of their meat labeling. According to international food safety lawyer Cesare Varallo, publisher of www.foodlawlatest.com, “No one thought before the [European horsemeat] scandal that this could be a real problem, so no one checked for this specific risk.” There were, however, other examples of food fraud brought to the American public’s attention this year, encompassing products like fish, olive oil, fruit juices, and honey.
During the course of 2013, the U.S. FDA finally released the five proposed rules under the Food Safety Modernization Act (FSMA), one of which covers its vigilance over imported foods. Says Varallo, “The FDA rules on imported food are strongly oriented to prevent this type of fraud from happening. Every importer will follow a Foreign Supplier Verification Program to demonstrate that imported food has the same level of safety as domestic food.”
The FSMA does not guarantee the absence of food fraud. However, DNA testing can affirm what species are contained in a piece of meat. Companies looking to verify their meat is not mislabeled may be interested in a product launched in August 2013. Lansing, Mich.-based company Neogen, providers of both ELISA (enzyme-linked immunosorbent assay) and PCR (polymerase chain reaction) species testing kits since 2009, introduced NeoSeek, a species identification lab service. To contract for the NeoSeek service, customers visit the Neogen website to request a test for the species of adulterant they are looking to find in their meat. Neogen will send out a sample shipping kit and the customer sends a 50 gram sample to Neogen’s testing facilities in Lincoln, Neb. Gerry Broski, senior marketing director, food safety for Neogen, says, “We have engineered the sample submission process to be as painless as possible. The samples are shipped to the GeneSeek Lab, and within 48 hours you get an email with DNA-definitive results on raw or cooked samples.”
NeoSeek detects adulteration at levels of 0.1 percent to 1 percent of mislabeled horse, pig, poultry, beef, or sheep meat, which corresponds to USDA MLG protocol of the levels at which food is considered adulterated. If the customer requires precise levels of the adulterant, quantitative results are available.
Looking at Allergens
Also in August 2013, the FDA published a definition of “gluten-free” to be used in voluntary food labeling. Previously there was no official federal definition for the term “gluten-free” used in claims. The new regulation sets a standard of no more than 20 parts per million (ppm) of gluten, a level that can be detected by scientifically validated, analytical methods. The agency chose this level because certain celiac researchers and some epidemiological evidence suggest most individuals with celiac disease can tolerate trace amounts of gluten in foods (including levels less than 20 ppm) without adverse health effects. FDA spokesman Arthur Whitmore explains, “The definition in the rule helps people with celiac disease and gluten sensitivity by setting a reliable and consistent standard for the claim on food products.”
Although some concerns have been raised that certain people can experience adverse effects from levels lower than this, the Gluten Intolerance Group of North America and the Celiac Disease Foundation support the new definition. The FDA recommends individuals who are extremely sensitive to any amount of gluten should consult with their physicians to develop an appropriate diet plan.
One way for companies to ensure a product meets the new FDA standards for gluten-free is to certify it through the NSF Gluten-Free Certification Program. NSF International is an independent, global organization that certifies products for the food, water, health sciences, and consumer goods industries to minimize adverse health effects and protect the environment. The NSF Gluten-Free Certification Program verifies that certified products contain 20 ppm or less of gluten, in line with Codex Alimantarius Commission Standard, the European Commission Regulation Health Canada, and the FDA regulation. When certification is successfully completed, the product earns a NSF Gluten-Free label.
During an onsite NSF inspection for certification, a random sample is collected and tested using ELISA-based methods to establish gluten-free integrity at 10 ppm or less. (Testing for a significantly lower gluten threshold than certification requirement of 20 ppm or less takes into account the variability of ingredient lots and batches and ensures, as well as possible, the food being tested never exceeds the allowed ceiling of 20 ppm of gluten.) The inspector verifies that the manufacturing process prevents gluten contamination of products, and raw ingredients have been tested for gluten. The inspector also verifies the allergen affidavits and certificate of analysis, as well as confirms raw ingredients were sourced from QAI (Quality Assurance International) Gluten-Free suppliers.
According to Jaclyn Bowen, general manager of NSF International Agriculture and QAI, “A well-developed and well-executed gluten-management program goes hand in hand with other food safety management systems. Testing alone is not sufficient to ensure the gluten-free compliance of your product. An investment in a quality management system that evaluates supplier assurance, good manufacturing practices, and ongoing training is your best option to ensure your products reproducibly meet the requirements of the FDA Gluten-Free Final Rule.”
The publication of the gluten-free definition draws more focus on the overall presence of various allergens. The year 2013 saw an advance in allergen testing born from a collaboration between Romer Labs of Tulin, Austria, and ifp Institüt fur Produktqualität of Berlin, Germany, when they launched the AgraQuant F.A.S.T. (Fast, Accurate, Simple Technology) ELISA test kit to meet the increasing number of restrictive government regulations.
Romer Labs gathered feedback from the food industry to help guide the development of the benefits of AgraQuant F.A.S.T. According to the company, it is currently the fastest allergen testing kit on the market, with an extraction time of one minute and an assay performance time of 30 minutes. A 1 gram sample is required, although Romer Labs recommends taking multiple samples that are well-homogenized then subsampled to ensure it is representative of the product. Two capsules, using a proprietary technology developed by ifp, are then added to the sample, one filled with extraction buffer and one with additional extraction enhancement substances. After 20 milliliters of hot water (80 degrees to 100 degrees Celsius) are added, the sample is shaken for 15 seconds so the capsules dissolve and proteins from the sample are extracted. The sample is then filtered or centrifuged so it can be used for the ELISA assay.
In addition to its fast time to results, Elisabeth Halbmayr-Jech, technical manager with Romer Labs, points out, “AgraQuant F.A.S.T. allows the technician to use one extract over multiple test kits to look for several allergens. This feature adds to the speed of the process and reduces the chance for error. Also, the test kit requires very little training.”
Testing for Pathogens
In 2013, Bio-Rad Laboratories, a Calif.-based food safety solutions provider, introduced a technology that marries process innovation and advanced data collection. The iQ-Check Prep is an automated PCR solution that tests for foodborne pathogens. The first element of the process is a line of highly nutritive broths that minimize enrichment time. After enrichment, the user takes samples from the broth and transfers them to a 96-deep well plate. The batch of samples is placed on the automated processing instrument which takes over the sample preparation and places it on the PCR plate. The user then removes the plate, seals it, and places it in the thermal cycler for PCR detection.
The system provides several advances, such as minimal handling of the sample to reduce error. In addition, the iQ-Check Prep uses air displacement pipettes that operate like plungers instead of a conventional vacuum system. This means there is no liquid passing through the system which could cause contamination. The instrument also features a liquid detection sensor that verifies if the lab technician did, in fact, transfer the liquid samples. The user can be confident therefore that a negative reading means that a sample is clean because no pathogenic bacteria are in the sample, not because there was no sample present to be tested.
This last innovation is part of the traceability capability the iQ-Check Prep offers. The machine documents each step of the process and exports information to the user’s laboratory information management system. At a later date, users can look up previously tested samples and find that a sample was actually present in the instrument, as well as review the results of the PCR assay. This documentation is valuable to meet documentation requirements.
Offering a variety of pricing solutions for companies, Wendy Lauer, senior product manager of the Bio-Rad Food Science Division, explains, “We look at it from a process standpoint. We want to help our customers optimize their workflow and traceability, so we work with them to make sure it is a fit for their lab.”
Another facet of FSMA is the requirement for preventative control systems modeled on Hazard Analysis and Critical Control Points (HACCP) for facilities that manufacture, process, pack, or hold food for human consumption. “We think that the proposed rule provides a science- and risk-based, as well as flexible, approach to preventing hazards in foods,” states Jenny Scott, senior advisor, office of food safety of the FDA. “It is based on internationally recognized principles of HACCP and best practices of industry.”
Preventing these food hazards would include sanitation controls. Providing HACCP management capabilities, BioControl Systems recently launched LIGHTNING MVP ICON system to test for cleanliness through the detection of adenosine triphosphate (ATP), a molecule found in most food residues as well as bacteria, yeast, and mold. The system consists of a handheld device to take readings and PC software for data analysis and tracing. The handheld unit can be used as follows to validate cleaning effectiveness and manage HACCP parameters.
Surfaces. A proprietary sampling device containing a luciferin/luciferase reagent is used to swab a surface. The reagent reacts with any ATP it finds on the swab to produce light. The ICON reads the light signal and interprets its intensity to determine where it falls within Pass/Warn/Fail parameters.
Rinse Water. A device designed specifically for sampling liquids collects a rinse water sample that is tested by the ICON to verify ATP thresholds in liquid samples are not exceeded.
Other HACCP Parameters. External probes to test for pH, temperature, and concentration can be connected via USB connection to the ICON. Acceptable thresholds for each can be entered into device and stored, and measurements are compared to these metrics to produce Pass/Fail results.
The ICON’s color touchscreen identifies each test point by name, date, and time taken, and also displays the results. ICON can be connected to a PC through a USB port and the results uploaded to the ICON Dashboard software that contains widgets to report on the current state of test points as well as their historic readings.
ICON Dashboard can be a valuable tool for HACCP monitoring. According to Anita Kressner, vice president global sales and marketing, “The MVP ICON Dashboard software provides at-a-glance reporting of the most critical performance metrics of a sanitation program. Essential information including the number of samples taken and the retest rate is updated in the dashboard each time the MVP ICON is synched with the computer. The dashboard also displays a reminder for the date the next calibration is due, which can be done onsite.”
Risk Management Technologies
FDA legislation centers around assessing and managing risk. A company called Battelle in Columbus, Ohio, has recently developed a technology called PRIA that can help the poultry industry in this endeavor. PRIA is actually based on Department of Homeland Security software that performs risk assessments using mathematical and statistical projections to map out the scope of the disaster should a biological or chemical attack assault the food supply chain. Because foodborne pathogens would follow the same path of distribution as a foodborne biological attack, the same risk assessment models can be used to identify the route and degree of damage of a pathogen.
PRIA can be used to model the outcomes of any safety measures a poultry company might potentially employ. A variety of alterations can be input, including Salmonella inoculations, an antimicrobial dip, or an initiative to prevent temperature abuse in distribution and retail. The program projects what changes would result downstream of the poultry company for each variable, allowing users to evaluate the outcomes and choose the most beneficial and most cost-effective improvements to be made. Brian Hawkins, senior research scientist at Battelle, explains, “You can look at these possibilities side by side and make a quantitative decision based on the impact. You can see by how much it will reduce projected illnesses or projected contamination.” At press time, Battelle was currently working with two poultry companies to take the PRIA prototype to launch.
Despite the most stringent sanitation and testing standards, foodborne pathogens can find their way into commerce, resulting in recalls. To keep consumers as safe as possible, the agency randomly demands food processing companies to stage mock recalls. In one of these exercises, companies must be able to identify the location of each lot of food they have shipped within two to four hours.
One of the challenges encountered during a food recall is locating where a particular lot number of raw ingredient has been used, thereby limiting the recall to strictly the contaminated food. Many manufacturing facilities are still using manual records, so in the event of a recall, finding the one paper that lists the final destination of an ingredient or finished product can be daunting. Often the company recalls everything on the shelf, doing deep and unnecessary damage to the brand. GE Intelligent Platforms, a division of General Electric, developed Proficy, a software package, to digitize this recordkeeping.
Compatible with multiple hardware and software products, Proficy collects data stored in the computer brain of each machine in the automated food processing factory including oven temperature, belt speed, and humidity, as well as data input by operators such as ingredient lot numbers. The program integrates the data, giving food suppliers a holistic “snapshot” of any moment or aspect of production. Moreover, if any problems arise, a warning is sent automatically to the person who needs to take appropriate corrective action. They can know in an instant if machinery was functioning properly, if conditions were correct, as well as where each ingredient and finished product wound up. According to Katie Moore, global industry manager, food and beverage for GE Intelligent Platforms, “Proficy is not just about collecting data for its own sake, but about collecting information seamlessly and getting it to the people who need it when they need it.”
As we enter 2014, there’s little doubt that the more comprehensive strategies adopted by food growers and processors will continue to offer food industry technology providers challenging, and potentially rewarding, opportunities for innovation. Though the full impact of FSMA has not yet been realized as the comment period for the final proposed rules are still ongoing, Scott reminds us that all the regulations promulgated by FSMA emphasize that the primary responsibility for food safety lies with the industry.
Cowan-Lincoln is a science/technical writer based in New Jersey. She is a frequent Wiley contributor who has been featured in numerous publications. Reach her at firstname.lastname@example.org.