Tag Archives: Food Labs

Sasan Amini

NGS in Food Safety: Seeing What Was Never Before Possible

By Sasan Amini
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Sasan Amini

For the past year, Swedish food provider Dafgård has been using a single test to screen each batch of its food for allergens, missing ingredients, and even the unexpected – an unintended ingredient or pathogen. The company extracts DNA from food samples and sends it to a lab for end-to-end sequencing, processing, and analysis. Whether referring to a meatball at a European Ikea or a pre-made pizza at a local grocery store, Dafgård knows exactly what is in its food and can pinpoint potential trouble spots in its supply chains, immediately take steps to remedy issues, and predict future areas of concern.

The power behind the testing is next-generation sequencing (NGS). NGS platforms, like the one my company Clear Labs has developed, consist of the most modern parallel sequencers available in combination with advanced databases and technologies for rapid DNA analysis. These platforms have reduced the cost of DNA sequencing by orders of magnitude, putting the power to sequence genetic material in the hands of scientists and investigators across a range of research disciplines and industries. They have overtaken traditional, first-generation Sanger sequencing in clinical settings over the past several years and are now poised to supplement and likely replace PCR in food safety testing.

For Dafgård, one of the largest food providers in Europe, the switch to NGS has given it the ability to see what was previously impossible with PCR and other technologies. Although Dafgård still uses PCR in select cases, it has run thousands of NGS-based tests over the past year. One of the biggest improvements has been in understanding the supply chain for the spices in its prepared foods. Supply chains for spices can be long and can result in extra or missing ingredients, some of which can affect consumer health. With the NGS platform, Dafgård can pinpoint ingredients down to the original supplier, getting an unparalleled look into its raw ingredients.

Dafgård hopes to soon switch to an entirely NGS-based platform, which will put the company at the forefront of food safety. Embracing this new technology within the broader food industry has been a decade-long process, one that will accelerate in the coming years, with an increased emphasis on food transparency both among consumers and regulators globally.

Transitioning technology

A decade ago, very few people in food safety were talking about NGS technologies. A 2008 paper in Analytical and Bioanalytical Chemistry1 gave an outlook for food safety technology that included nanotechnology, while a 2009 story in Food Safety Magazine2 discussed spectrometric or laser-based diagnostic technologies. Around the same time, Nature magazine named NGS as its “method of the year” for 2007. A decade later, NGS is taking pathogen characterization and food authentication to the next level.

Over the last 30 years, multiple technology transitions have occurred to improve food safety. In the United States, for example, the Hazard Analysis and Critical Control Points (HACCP) came online in the mid-1990s to reduce illness-causing microbial pathogens on raw products. The move came just a few years after a massive outbreak of E. coli in the U.S. Pacific Northwest caused 400 illness and 4 deaths, and it was clear there was a need for change.

Before HACCP, food inspection was largely on the basis of sight, touch, and smell. It was time to take a more science-based approach to meat and poultry safety. This led to the use of PCR, among other technologies, to better measure and address pathogens in the food industry.

HACCP set the stage for modern-era food testing, and since then, efforts have only intensified to combat food-borne pathogens. In 2011, the Food Safety Modernization Act (FSMA) took effect, shifting the focus from responding to pathogens to preventing them. Data from 20153 showed a 30% drop in foodborne-related bacterial and parasitic infections from 2012 to 2014 compared to the same time period in 1996 to 1998.

But despite these vast improvements, work still remains: According to the CDC, foodborne pathogens in the Unites States alone cause 48 million illnesses and 3,000 fatalities every year. And every year, the food safety industry runs hundreds of millions of tests. These tests can mean the difference between potentially crippling business operations and a thriving business that customers trust. Food recalls cost an average of $10M per incident and jeopardize public health. The best way to stay ahead of the regulatory curve and to protect consumers is to take advantage of the new technological tools we now have at our disposal.

Reducing Errors

About 60% of food safety tests currently use rapid methods, while 40% use traditional culturing. Although highly accurate, culturing can take up to five days for results, while PCR and antigen-based tests can be quicker – -one to two days – but have much lower accuracy. So, what about NGS?

NGS platforms have a turnaround of only one day, and can get to a higher level of accuracy and specificity than other sequencing platforms. And unlike some PCR techniques that can only detect up to 5 targets on one sample at a time, the targets for NGS platforms are nearly unlimited, with up to 25 million reads per sample, with 200 or more samples processed at the same time. This results in a major difference in the amount of information yielded.

For PCR, very small segments of DNA are amplified to compare to potential pathogens. But with NGS tools, all the DNA is tested, cutting it into small fragments, with millions of sequences generated – giving many redundant data points for comparing the genome to potential pathogens. This allows for much deeper resolution to determine the exact strain of a pathogen.

Traditional techniques are also rife with false negatives and false positives. In 2015, a study from the American Proficiency Institute4 on about 18,000 testing results from 1999 to 2013 for Salmonella found false negative rates between 2% and 10% and false positive rates between 2% and 6%. Several Food Service Labs claim false positive rates of 5% to 50%.

False positives can create a resource-intensive burden on food companies. Reducing false negatives is important for public health as well as isolating and decontaminating the species within a facility. Research has shown that with robust data analytics and sample preparation, an NGS platform can bring false negative and positive rates down to close to zero for a pathogen test like Salmonella, Listeria, or E.coli.

Expecting the Unexpected

NGS platforms using targeted-amplicon sequencing, also called DNA “barcoding,” represent the next wave of genomic analysis techniques. These barcoding techniques enable companies to match samples against a particular pathogen, allergen, or ingredient. When deeper identification and characterization of a sample is needed, non-targeted whole genome sequencing (WGS) is the best option.

Using NGS for WGS is much more efficient than PCR, for example, at identifying new strains that enter a facility. Many food manufacturing plants have databases, created through WGS, of resident pathogens and standard decontamination steps to handle those resident pathogens. But what happens if something unknown enters the facility?

By looking at all the genomic information in a given sample and comparing it to the resident pathogen database, NGS can rapidly identify strains the facility might not have even known to look for. Indeed, the beauty of these technologies is that you come to expect to find the unexpected.

That may sound overwhelming – like opening Pandora’s box – but I see it as the opposite: NGS offers an unprecedented opportunity to protect against likely threats in food, create the highest quality private databases, and customize internal reporting based on top-of-the-line science and business practices. Knowledge is power, and NGS technologies puts that power directly in food companies’ hands. Brands that adopt NGS platforms can execute on decisions about what to test for more quickly and inexpensively – all the while providing their customers with the safest food possible.

Perhaps the best analogy for this advancement comes from Magnus Dafgård, owner and executive vice president at Gunnar Dafgård AB: “If you have poor eyesight and need glasses, you could be sitting at home surrounded by dirt and not even know it. Then when you get glasses, you will instantly see the dirt. So, do you throw away the glasses or get rid of the dirt?” NGS platforms provide the clarity to see and address problem directly, giving companies like Dafgård confidence that they are using the most modern, sophisticated food safety technologies available.

As NGS platforms continue to mature in the coming months and years, I look forward to participating in the next jump in food safety – ensuring a safe global food system.

Common Acronyms in Food Genomics and Safety

DNA Barcoding: These short, standardized DNA sequences can identify individual organisms, including those previously undescribed. Traditionally, these sequences can come from PCR or Sanger sequencing. With NGS, the barcoding can be developed in parallel and for all gene variants, producing a deeper level of specificity.

ELISA: Enzyme-linked immunosorbent assay. Developed in 1971, ELISA is a rapid substance detection method that can detect a specific protein, like an allergen, in a cell by binding antibody to a specific antigen and creating a color change. It is less effective in food testing for cooked products, in which the protein molecules may be broken down and the allergens thus no longer detectable.

FSMA: Food Safety Modernization Act. Passed in 2011 in the United States, FSMA requires comprehensive, science-based preventive controls across the food supply. Each section of the FSMA consists of specific procedures to prevent consumers from getting sick due to foodborne illness, such as a section to verify safety standards from foreign supply chains.

HACCP: Hazard analysis and critical control points. A food safety management system, HACCP is a preventative approach to quantifying and reducing risk in the food system. It was developed in the 1950s by the Pillsbury Company, the Natick Research Laboratories, and NASA, but did not become as widespread in its use until 1996, when the U.S. FDA passed a new pathogen reduction rule using HACCP across all meat and poultry raw products.

NGS: Next-generation sequencing. NGS is the most modern, parallel, high-throughput DNA sequencing available. It can sequence 200 to 300 samples at a time and generates up to 25 million reads per a single experiment. This level of information can identify pathogens at the strain level and can be used to perform WGS for samples with unknown pathogens or ingredients.

PCR: Polymerase chain reaction. First described in 1985, PCR is a technique to amplify a segment of DNA and generate copies of a DNA sequence. The DNA sequences generated from PCR must be compared to specific, known pathogens. While it can identify pathogens at the species level, PCR cannot provide the strain of a pathogen due to the limited amount of sequencing information generated.

WGS: Whole genome sequencing. WGS uses NGS platforms to look at the entire DNA of an organism. It is non-targeted, which means it is not necessary to know in advance what is being detected. In WGS, the entire genome is cut it into small regions, with adaptors attached to the fragments to sequence each piece in both directions. The generated sequences are then assembled into single long pieces of the whole genome. WGS produces sequences 30 times the size of the genome, providing redundancy that allows for a deeper analysis.

Citations

  1. Nugen, S. R., & Baeumner, A. J. (2008). Trends and opportunities in food pathogen detection. Analytical and Bioanalytical Chemistry, 391(2), 451-454. doi:10.1007/s00216-008-1886-2
  2. Philpott, C. (2009, April 01). A Summary Profile of Pathogen Detection Technologies. Retrieved September 08, 2017, from https://www.foodsafetymagazine.com/magazine-archive1/aprilmay-2009/a-summary-profile-of-pathogen-detection-technologies/?EMID
  3. Ray, L., Barrett, K., Spinelli, A., Huang, J., & Geissler, A. (2009). Foodborne Disease Active Surveillance Network, FoodNet 2015 Surveillance Report (pp. 1-26, Rep.). CDC. Retrieved September 8, 2017, from https://www.cdc.gov/foodnet/pdfs/FoodNet-Annual-Report-2015-508c.pdf.
  4.  Stombler, R. (2014). Salmonella Detection Rates Continue to Fail (Rep.). American Proficiency Institute.
Robert Ferguson, Strategic Consulting

Contract Food Labs Gain Traction

By Maria Fontanazza
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Robert Ferguson, Strategic Consulting

Last month Food Safety Tech and Bob Ferguson, managing director at Strategic Consulting, discussed changes that are affecting the contract lab industry, from processor concerns in keeping pathogens out of their facility to operational challenges. In part II of our interview, Ferguson reviews how these factors are increasing competition among food contract laboratories.

Food Safety Tech:  Since we published your article “Changing Landscape for Selecting a Food Contract Laboratory” you’ve mentioned that you have been getting quite a few questions about the piece, your study and your findings. What is the most common question you have received?

Robert Ferguson: It’s been interesting! I have received questions directly via email and many over various social media. People have been very interested in the overall impact that these changes will have on the market. As more and more companies outsource their food diagnostic testing, and as food contact labs companies capture a greater share of the testing market and also grow through consolidation of the market, testing labs will have greater market power. It is a common purchasing practice, of course, for buyers to commoditize services such as laboratory analysis to the extent that they can and then force the labs to sell on price. This has clearly been the case in the food lab market. But as more companies outsource, and the larger labs grow and consume greater share, the balance of bargaining power between the larger labs and processors will change.

FST:  Is it just the relative size of the labs that is having the major impact?

Robert Ferguson, Strategic Consulting
Robert Ferguson, managing director, Strategic Consulting, Inc., will discuss the results of the survey at the 2016 Food Safety Consortium in December | LEARN MORE

Ferguson:  Larger lab companies will certainly have economies of scale, operating efficiencies and bargaining power with their suppliers that the smaller labs will not that they will use to their advantage. But there is more to it than that. Close to 70% of the processors in our survey say that they outsource their pathogen samples to labs within 100 miles of their plant. Many of these processors are multi-site operations and will look to outsource their work with the fewest number of laboratory contracts. With growth and consolidation in the market, fewer and fewer lab companies will have laboratories in the right places to meet this 100-mile requirement. Fewer labs will qualify for the bidding process, and this will reduce competition.

FST:  Will this change pricing?

Ferguson: Probably, especially over time. The other thing we heard from processors is that economics is not the main criteria in their decision to outsource. Traditionally, processors would “do the math” and those with fewer samples would outsource, as it would not be economical to maintain their own lab operation, while those with high sample volumes would run their own plant lab or a consolidated corporate lab. But what we hear from processors is a greater focus on food safety and a desire to get any work with pathogens out of their plant. We also hear more reluctance from processors to be “in the lab business.” Their core competence is food production, not maintaining lab accreditations, keeping up to date on more sophisticated analytical techniques, and everything else it takes to maintain an efficient lab operation. Neither of these goals is economic, and we are seeing more companies outsource their samples at a higher cost per sample than what it was costing at their in-plant lab. Less competition and more focus on qualitative goals and not just pricing will create longer-term increases in contract lab prices.

Read part I of the Q&A with Ferguson, “Increased Testing for Pathogens and More Complex Tests Means More Outsourcing”FST:  That sounds positive for food contract laboratories. What is the risk?

Ferguson: These changes will be a significant opportunity for some food contract lab companies and a significant risk for others. Those who can create the best lab network will qualify for the most outsourcing contracts and will likely be far more competitive. Single location labs, however, will find it harder to be competitive, and many will likely be acquired while others will fail. We will certainly see a continued high level of M&A activity in this market.
Some of the other questions people have asked are about the impact on lab companies’ strategies, outside of M&A. We have heard from processors that while the larger labs with the better networks are better outsourcing partners, they are also finding that these larger lab companies are more “industrialized” and have far less emphasis on customer service. This seems to introduce an opportunity for a laboratory company with a strong network that can also maintain a high level of customer service to gain a competitive advantage.  We see some indication that this is already happening as more lab companies offer services such as auditing, onsite inspections and testing, and program development. In fact, our data shows that services, while still a small proportion of most food contact lab’s revenue, is nonetheless the fastest growing component, overall growing at nearly 15%. This seems to be a clear opportunity for food contract labs to differentiate themselves and stay competitive.

AOAC Neogen

Neogen’s AccuPoint Advanced receives AOAC approval

AOAC Neogen

Neogen recently received approval from the AOAC Research Institute for its rapid and accurate AccuPoint Advanced ATP Sanitation Verification System.

Neogen’s AccuPoint Advanced is the first sanitation verification system to receive an AOAC approval, and this approval follows a recent study by NSF International that showed AccuPoint Advanced exceeded the performance of competitive systems.

“Each time we receive a validation from an independent third party on any of our tests, it provides further assurance to the food production and processing industry that our tests perform as expected,” said Ed Bradley, Neogen’s vice president of Food Safety. “The performance of our AccuPoint Advanced system in recent independent evaluations by AOAC and NSF is very gratifying. We developed the product with the goal of creating a new sanitation verification system that is superior to anything else on the market.”

The results in the AOAC validation report (Performance Tested MethodSM 091601) provided evidence that AccuPoint Advanced produces consistent and reliable data for evaluating sanitation program effectiveness in food processing and food services facilities.

AccuPoint Advanced is an enhanced version of its earlier AccuPoint test system. Improvements with AccuPoint Advanced include: improved sampler chemistry to produce more consistent results with even greater sensitivity; an enhanced instrument to produce even faster results (less than 20 seconds); and advanced Data Manager software to easily streamline the testing process by creating test plans and syncing important data, while keeping a permanent record of sanitation test results.

AOAC International is a globally recognized, independent forum for finding appropriate science-based solutions through the development of microbiological and chemical standards. The Applied Research Center at NSF International is a not-for-profit global research group that provides product development support to manufacturers and developers of products in the food safety, agriculture, clinical and life science markets.

Robert Ferguson, Strategic Consulting

Increased Testing for Pathogens and More Complex Tests Means More Outsourcing

By Maria Fontanazza
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Robert Ferguson, Strategic Consulting

Companies are under more pressure to analyze food samples for pathogens, but not all of them have the expertise to handle the complexity involved in laboratory analysis. In addition, companies don’t want to risk contamination throughout their facility. As a result, many are outsourcing these services to contract labs.

Changing Landscape for Selecting a Food Safety Contract Laboratory

Strategic Consulting, Inc. recently conducted a study of food processors and the trends in outsourcing their laboratory testing work to food contract laboratories. The firm spoke with 100 food processors nationwide in 15 food processing categories, including protein, dairy, vegetables and packaged foods, inquiring about the types of samples they collect, how many are collected on a daily and monthly basis, their target analytes, and where they have the analysis performed (an in-plant lab, central company lab or an outsourced food contract laboratory); the firm also spoke with folks at leading food companies and a number of large food contract labs.

Bob Ferguson, managing director at Strategic Consulting, shared his insights with Food Safety Tech about the survey, the details of which will be presented at the Food Safety Consortium in December.

Food Safety Tech:  What were some of the major findings?

Bob Ferguson: Food processors continue to outsource more and more of their lab analysis.  This is a trend that we outlined in our Food-8 market report in 2014, and it is clearly continuing and growing. The impact is particularly acute in microbiology testing, especially when analysis is for pathogens.  Of the companies we surveyed, 87% did some amount of routine microbiology testing and 67% of those analyzed the samples at an in-house lab. But when asked about pathogens, 77% of the companies analyze samples for pathogens but only 34% analyze the samples at an in-house lab.  Clearly there is a higher level of concern in handling pathogens at in-house labs.

Food Safety Tech: What are the processors’ concerns regarding pathogens?

Ferguson: I would say that their concerns fall into two major categories: Technical and operational. From a technical perspective, there is always a risk when working with pathogens in a food processing facility. Microbiologists understand how easily bacteria can travel through a facility—being carried on employees, their clothing, or equipment, through air currents, or even through penetration connections such as drains. And most diagnostic tests not only require handling pathogen samples but also enriching the samples prior to analysis. The presence of food samples with high concentrations of pathogens can present a risk for the spread of contamination into production areas.

From an operational standpoint, running a food analysis lab is becoming increasingly more complex. Analytical methods continue to get more sensitive and sophisticated, and this requires more expertise and a greater focus on instrument service and calibrations.  Requirements for accreditation of food testing laboratories are also raising the bar for in-plant labs.  Finally, running a food lab requires recruiting and hiring skilled analysts. More food processors are coming to the conclusion that none of these functions are part of their core competencies and are electing to outsource that work to a contract lab.

Robert Ferguson, Strategic Consulting
Robert Ferguson, managing director, Strategic Consulting, Inc., will discuss the results of the survey at the 2016 Food Safety Consortium in December | LEARN MORE

Food Safety Tech:  What does this mean for food contract labs?

Ferguson: This could become a significant business growth opportunity for food contract laboratories.  As we indicated in our Food Contract Laboratory market report, microbiology is one of the largest business areas for most food contract laboratories, comprising, on average, approximately 52% of lab revenues and growing on average at 12% annually. The average lab also reports pathogen testing growth at more than 13%. This is remarkable in that the overall growth in sample volume is only growing 6%, so labs are clearly gaining a greater share of samples.

Food Safety Tech: Is this good news for the food contract laboratory companies?

Ferguson: Well, I would say that this will dramatically change the nature of competition and will be good news for some lab companies, namely those who can best adapt to the changing market conditions, but certainly not all.  Our analysis shows, for example, that about 70% of pathogen samples outsourced are sent to a lab within 100 miles of the food processing facility.   This bodes well for labs with a robust national network of locations. Single-location or limited-location labs may have trouble competing and will be acquired or otherwise may not survive. Also, as more samples get outsourced, the most efficient laboratories will have a competitive advantage. Our data also shows that outsourcing does not occur uniformly across all types and sizes of food processing companies, and laboratories may be at more or less risk depending on their customer mix or concentration in a particular food processing segment. Food contract laboratories that understand these factors will be in a better position to compete and thrive as the market changes.

Food Lab count

Infographic: How Many Food Labs Are in the United States?

By Food Safety Tech Staff
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Food Lab count

Food Safety Tech: Earlier this year in “Counting Food Laboratories”, you discussed the fact that there is an unknown amount of food laboratories in the United States and an inconsistency in how we account for the labs testing our food. What impact does this have on the industry?

Robin Stombler, president of Auburn Health Strategies: There is limited information available on the presence and quality of food laboratories in the United States. Without this essential accountability, the health of the public, the economy and our nation’s security are at risk. For example, when a new food pathogen emerges, we do not have a system for contacting and educating all existing food laboratories on how to detect it. Frankly, we do not know where all food laboratories are located, so we do not know if they are properly equipped to handle the detection, monitoring or verification responsibilities. The lack of data also makes it difficult for industry to plan, track testing trends, and improve quality.

Counting Food Labs
Infographic courtesy of Auburn Health Strategies; Credit: Justin Stombler
USDA Logo

USDA Touts Food Safety Progress Under Obama Administration

By Food Safety Tech Staff
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USDA Logo

Between 2009 and 2015 there was a 12% reduction in foodborne illnesses associated with meat, poultry and processed egg products. “We’re better now at keeping unsafe food out of commerce, whether it’s made unsafe because of dangerous bacteria, or because of an allergen, like peanuts or wheat,” said Agriculture Secretary Tom Vilsack in a USDA release. “Over the course of [President Obama’s] Administration, we have tightened our regulatory requirements for the meat and poultry industry, enhanced consumer engagement around safe food handling practices, and made smart changes to our own operations, ultimately moving the needle on the number of foodborne illness cases attributed to products that we regulate.”

USDA’s Food Safety and Inspection Service (FSIS) has implemented a number of initiatives since 2009, including:

  1. Establishing a zero-tolerance policy for raw beef products that contain shiga-toxin producing E. coli: O26, O103, O45, O111, O121 and O145.
  2. Labeling mechanically tenderized meat. The blades or needles used to tenderize meat an introduce pathogens into the meat.
  3. First-ever pathogen reduction standards for poultry parts in order to reduce consumer exposure to Salmonella and Campylobacter. The standard is expected to prevent 50,000 cases of foodborne illness each year.
  4. Requiring that all poultry facilities create a plan to prevent contamination with Salmonella and Campylobacter, instead of addressing the problem after it occurs. Poultry companies must collect samples at two points in the production line and test them to show control of enteric pathogens.
  5. Requiring meat and poultry companies to hold all products that are undergoing lab analysis until USDA microbial and chemical tests for harmful hazards are complete.
Suresh Neethirajan, University of Guelph
In the Food Lab

Identifying Peanut and Other Allergens Outside the Lab

By Suresh Neethirajan, Ph.D
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Suresh Neethirajan, University of Guelph

Judging the nature and suitability of items we put in our mouths is a task we perform daily, whether it’s due to different taste preferences, being on a diet, or from particular foods not agreeing with our metabolisms. Some foods can trigger mild reactions such as an upset stomach, or more serious skin rashes and outbreaks, from shortness of breath to even death.

Many of us have been somewhere where someone with a peanut allergy has been brought to everyone’s attention. The situation may have been publicized before boarding a plane, at a school where parents are asked to refrain from giving their children any food containing peanut products, or restaurants that clearly indicate which dishes are peanut-free on their menu, or that the kitchen is absent of the legume.

The number of people with food allergies continues to rise, and although many theories have been provided for the increase, the exact cause is unknown. Many foods are documented as being able to produce an allergic reaction—milk, eggs, soy and shellfish, to name a few—but peanuts and gluten are highlighted as major offenders. Canadian government regulations require that manufacturers label products that contain certain allergens, even if they are made in a facility where allergens are in another product.

The Threat of Gluten and Peanuts

Gluten contained in wheat has become a widely avoided food substance, although the reason for this might has more to do with health concerns than allergies. The American College of Allergy, Asthma and Immunology (ACAAI) estimates that 400,000 U.S. school children have a peanut allergy, with many of those also having other food allergies. According to the ACAAI, many children will eventually outgrow most food allergies, but only 20% of those who have a peanut tolerance will outgrow it.

The charity organization Food Allergy Canada states that 2.5 million people suffer from a food allergy in Canada, while 2 in 100 children are susceptible to peanuts causing a reaction. There isn’t a cure for food allergies, so governments and food inspectors have the weighty task of ensuring that commercially produced products are packaged or served with proper labeling and information to protect consumers. This requires constant checking and testing of products that may have come in contact with peanuts or gluten.

New Tool for Food Inspectors

To provide regular analysis, the procedure has been lengthy and expensive, but scientific researchers at Canada’s University of Guelph have developed an apparatus that can identify allergens in a much shorter time span while being considerably more cost effective. The new allergen detector could expedite allergen reporting and possibly reduce the number of allergic reactions through more timely results.

Biosensor, University of Guelph
Schematic of the biosensor for the rapid detection of food allergens. Image courtesy of BioNanoLab, University of Guelph.

Based on the ELISA (enzyme-linked immunosorbent assay) platform that is widely used in diagnostic labs to identify allergens, the new apparatus provides comparable accuracy. The technology has been miniaturized so that equipment is portable, about the size of an audiocassette case, and tests can be conducted on location instead of relying on a lab that may be far away.

An Allergen that Glows

In the case of peanuts, the scientists focused on a prominent allergen named Ara h 1, because it can be identified through non-radioactive fluorescence. Although there are other allergens in peanuts, they don’t share the same property by which they can be identified, as does Ara h 1.

The process requires a small amount of the suspected food to be liquefied in a suspension so that it can be injected using a filter syringe into a silicon-based plate, or chip, of microcapillaries. As the sample passes through tiny tubes of the microfluidic chip using capillary action, it travels through a beam of light from a LED source that is monitored by a specialized camera, which is also a product of the scientists’ work.

The image captures Ara h 1 protein particles that fluoresce when they come in contact with the chemical properties of the suspension. Currently, the camera records the data and sends it to a computer to be analyzed and deciphered with a result being provided within 20 minutes, compared to a conventional lab test that takes up to four hours after a sample has been received.

In a modification to provide an extremely portable system, research is underway to develop an app to enable results via a smartphone. Testing foods in the near future will be as convenient and prompt as holding the detector in one hand and a smartphone in the other so that a restaurant owner, for example, will be assured that dishes are allergen-free before being served to customers.

Imitating the Human System for Detection

To enable the allergen to fluoresce, the compound graphene oxide (GO) was utilized in combination with a bio-sensing component, known as an aptamer. The aptamer acts similarly to antibodies that identify and attach themselves to foreign and hostile elements that enter our blood system. Once a GO-aptamer mixture is attached to the allergen, the light source allows the protein particle to be detected and its image captured electronically.

By altering an aptamer’s composition to identify other allergens, such as gluten, the detector is a versatile piece of scientific equipment for identifying potentially hazardous food ingredients. The developers of the technology are confident that their discovery will change the future of identifying potentially hazardous food components. The final step in the allergen detector’s development seems to be fine tuning the detection process for certain processed foods, such as roasted peanuts, that can alter the composition of Ara H 1 making it less obvious to be identified.

Counting Food Laboratories

By Robin Stombler
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What We Think We Know

Food laboratories in the United States may voluntarily choose to become accredited to an international standard known as ISO/IEC 17025:2005. This standard outlines the general requirements for the competence of testing laboratories.

More recently, the FDA issued a final rule on the Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications (Third-Party rule). Effective January 26, 2016, this final rule states that “for a regulatory audit, (when) sampling and analysis is conducted, the accredited third-party certification body must use a laboratory accredited in accordance with ISO/IEC 17025:2005 or another laboratory accreditation standard that provides at least a similar level of assurance in the validity and reliability of sampling methodologies, analytical methodologies, and analytical results.”  In short, for a segment of food laboratories, accreditation has become a necessary credential. At present, it remains a voluntary activity for most food laboratories.

There are accreditation bodies that accredit food laboratories to the ISO/IEC 17025 standard. The major accreditation bodies report on their individual websites which U.S. food laboratories are accredited under their watch.

To find the number of accredited laboratories, a quick search of the websites of four major food laboratory accreditation bodies, A2LA (American Association for Laboratory Accreditation), AIHA-LAP (American Industrial Hygiene Association – Laboratory Accreditation Programs, LLC), ANAB (American National Standards Institute-American Society for Quality), and PJLA (Perry Johnson Laboratory Accreditation) was performed on February 24, 2016. It yielded some debatable results. Here are some of the reasons for the skepticism:

  • The numbers are self-posted to individual websites. The frequency with which these websites are reviewed or updated is unknown.
  • Sites list both domestic and international laboratories. While foreign addresses were excluded from the count, those laboratories could perform testing for U.S. entities.
  • It can be difficult to separate the names of laboratories performing testing on human food versus animal feed.
  • There are several ways to duplicate or even exclude numbers. As examples, laboratories may be accredited within a food testing program, but may also be accredited under “biological” and/or “chemical” schemes—or vice versa.
  • In some cases, it is difficult to discern from the listings which laboratories are accredited for food testing versus environmental or pharmaceutical testing.

With all these caveats, the four major laboratory accreditation bodies accredit approximately 300 food laboratories. A2LA captures the lion’s share of this overall number with approximately 200 laboratories.

Let’s move to another source of numbers. A Food Safety News article about food testing and accreditation published in October 2013 states:

But, when it comes to testing our food, experts estimate that less than five percent of the food testing laboratories in the U.S. are accredited according to international standards…

Some believe that FDA will begin requiring accreditation for at least some significant segment of the food testing industry, of which the U.S. has roughly 25,000 laboratories. Whether that’s restricted to third-party labs – numbering roughly 5,000 – or will also include all food manufacturers’ internal labs is yet to be seen.

Using the writer’s sources, simple arithmetic finds 25,000 laboratories multiplied by the estimated 5% accreditation equals roughly 1,250 accredited laboratories in the United States. This, of course, falls far short of the 300 accredited laboratories noted by the major accreditation bodies. This is not to question either the writer’s sources or the websites of the accreditation bodies, but it does highlight an inconsistency in how we account for the laboratories testing our food.

To go a step further, Auburn Health Strategies produced in 2015, a survey of food laboratory directors, technical supervisors and quality assurance managers on the state of food testing. The survey, commissioned by Microbiologics, asked a series of questions, including: “Are the laboratories you use accredited?”  The respondents replied that, for their on-site laboratories, 42% were accredited and 58% were not. For their outside, contract laboratories, 90% of respondents stated that these laboratories were accredited and five percent did not know.

A second question asked: “Some laboratories are accredited to an internationally-recognized standard known as ISO 17025. Is this important to you?”  Approximately 77% of respondents answered affirmatively. Equally telling, 15% said they did not know or were unsure.

ISO 17025

What we do know is that there is not a definitive accounting of food laboratories—accredited or not. This lack of accounting can present very real problems. For example, we do not have a centralized way of determining if a particular laboratory has deficiencies in testing practices or if its accreditation has been revoked. Without knowing where and by whom testing is conducted, we are at a disadvantage in developing nationwide systems for tracking foodborne disease outbreaks and notifying laboratory professionals of emerging pathogens. We most certainly do not know if all food laboratories are following recognized testing methods and standards that affect the food we all consume.

What We Need Now

FSMA includes a provision calling for the establishment of a public registry of accreditation bodies recognized by the Secretary of Health and Human Services. The registry would also contain the laboratories accredited by such recognized organizations. The name and contact information for these laboratories and accreditation bodies would be incorporated into the registry. Rules for the registry have not yet been promulgated by the FDA, but should be. This is a small step toward greater accountability.

David Fried, Food Labs
In the Food Lab

Food Labs: Authentic and Safe Food is Key

By David Fried
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David Fried, Food Labs

The recent Foods Lab Conference (co-located with Pittcon) was an intersection of compliance, technology and best possible practices. One of the goals of this international symposium was to have laboratories and the food industry recognize one another as part of an effort for a more intentional and collaborative system in the industry, especially in terms of policies and practices.

As a Food Science student from Tallahassee, Florida I ended up at this incredible conference after seeing a blurb for it on LinkedIn and was able to attend as an intern. The two main objectives of my role were to assist with various tasks to help ensure the event transitioned smoothly, as well as further my knowledge base of the enormous realm of food safety. The following are some themes that I heard throughout the two days.

Having the analysis and validation performed or overseen with preventative types of controls from a qualified individual should ideally occur before the food safety plan is implemented. This appears to be desired by the consensus and was a common thread during the conference. If there is a change in a process control, it can have a serious impact on the legitimacy of the documentation if the change is not taken into account. The ISO implementations are food safety management systems and hazard analysis identification, which is the international benchmark for compliance standards.

Analytical scientific instrumentation is absolutely necessary for guaranteeing data and reproducibility on a consistent basis. The scope and complexity of modern technology should be considered when used for repeated trials in which the narrowest margins of results are being demanded by consumers and industry. Microbiologists confirm their peace of mind is reliant on the ability for reproducible experimental trials. In a laboratory, the presence of variables and species must be handled in an extremely controlled manner. All too frequently undesirable organisms appear in foods, and this is often the result of poor food handling practices, fraudulent practices or summed up, lazy shortcuts for the most unthinkable reasons. An effort to decrease these microbes is being made through transparency in supply chains to trace the journey of the food from seed to the table.

Food production is being shaped as a result of FSMA, which is a milestone in food safety. A few features of this legislation are to offer assistance for the food technology sector and address questions about policy and safe handling practices. It has and will continue to influence the process of laboratory accreditation, validation and compliance in order to provide thorough transparency for the development of more modern food systems. There were many fascinating perspectives shared about validation and accreditation for both laboratories and facilities. Many large companies have their laboratories in-house, because it is easier from a production perspective if the product is going to market, to test it repeatedly in order to have less delay in the market launch. There have been times in which carcinogenic fillers or fake foods were portrayed. Examples would be the horse meat and melamine scandals. An additional perspective would be the possibility in protecting the own interests of the company by not disclosing true ingredients, practices, or actual comprehensive food safety evaluation. All are truly unacceptable with regards to mega food base distribution companies. Small- to medium-sized businesses typically source laboratory evaluations to third-party assessors to perform product validation because it’s simply too expensive to implement on their own because of labor, technology and space constraints. Claims of 100% pure olive oil are not true the majority of the time. A sunflower oil and chlorophyll solution can be made to mimic the coloration of pure extra virgin olive oil. So it is commonplace for this sort of solution to be created and combined with pure olive oil at a ratio of 2:1, as a conservative figure. True wording and claims are becoming a thing of the past, because it is way too simple for big food business to engage in such unthinkable practices to maximize their own profits.

A key thread running throughout the conference was the importance of necessitating the collaborative efforts needed to achieve a comprehensive dialogue set in place as a universal type of database. This database would serve as the foundation to ensure safe food practices throughout worldwide food production companies, accredited laboratories, governments, and consumers.

The Food Labs Conference was truly one of fantastic speakers, interesting participants, and fascinating conversation. The advanced topics were explored by professionals who share a deep passion for this vital industry sector. Food Laboratories and the conference, respectively, will become even more revolutionary in terms of future technology, the influence garnered by key publics, and future experts.

Palmer Orlandi, Food Labs Conference

Problem: Lab Systems for Data Don’t Talk to Each Other

By Food Safety Tech Staff
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Palmer Orlandi, Food Labs Conference

FDA has standard templates and worksheets, along with an electronic submission form that can be used to pull data related to lab testing. However, within industry not all of these electronic systems speak to each other. During an FDA Town Hall at the Food Labs Conference last week, Palmer Orlandi, Ph.D., acting chief science officer and research director at FDA’s Office of Food and Veterinary Medicine, answers an audience question about the issue and discusses the challenges associated with standardized templates that are used by various federal and state labs and the compatibility issues.