Ask the Expert: What do processors need for rapid Salmonella detection methods?

By Food Safety Tech Staff
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Rapid technologies address the trend toward environmental testing versus finished product testing.

During the past decade, incidences of Salmonella have failed to drop, and the pathogen continues to pose a serious problem to the food supply. Meredith Sutzko, Product Manager, Food Pathogens at Romer Labs North America discusses current technology needs for the food industry.

Q: What are processors looking for in Salmonella detection methods?

Sutzko: I think we will see an increase in testing related to the Food Safety Modernization Act, and there’s a trend toward environmental testing as opposed to finished product testing. Instead of waiting to test finished products at the end of a production cycle, we’re finding that processors are taking a lot of environmental samples from the production line in different areas in order to find contamination further upstream so that when they get to the product testing, they have a lot of confidence that the product is going to be pathogen-free.

Processors are looking to identify contamination very early in the process. To do that, they need simple and cost-effective methods, especially ones that will deliver a fast time-to-result and can be used at the production facility so they don’t have to wait to obtain test results. By using test methods on-site, they can immediately take action upon getting the test result.

Q: How is RapidChek® differentiated from other rapid methods currently available?

Sutzko: The RapidChek method is an innovative, simple and easy-to-use test. With this test, we typically focus on the enrichment portion of the rapid method, because if salmonella is present in the environment, it’s going to be present at very low levels. The enrichment portion (or the growth phase), is important to get that pathogen to higher concentrations for detection.

We use innovative bacteriophage technology in our enrichment media. The bacteriophage act as selective agents during enrichment to inhibit the growth of competing microorganisms, which could be present. The phages allow an optimal growth environment for Salmonella, if it’s present, by reducing the growth of these other competitors. It helps to provide a fast time to result. Then we combine the enrichment media with a state-of-the art-lateral flow test, which uses highly purified antibodies that have been optimized for the sensitive and specific detection of Salmonella.

The technology is simple and easy to use. The end user doesn’t need any expensive equipment to run it. The method comes all-inclusive with everything necessary to run it, so there are no additional expenditures on consumables. Producers are able to do a lot more testing using the RapidChek, because it’s so cost effective. If they find contamination or a growth-niche, they can sanitize, take action and do more testing to make sure they’ve gotten rid of the pathogen.

Q: What’s the significance of Salmonella detection right now as it relates to the risk that the pathogen poses to the food supply?

Sutzko: Historically, Salmonella has been associated with meat and poultry. Recently we’ve seen a lot more outbreaks in different types of food products and matrices that historically have not been associated with Salmonella. Also, the food supply is being globalized. We’re receiving a lot of foods from different countries, possibly where their food safety standards are not as stringent as we have in the United States. We’re seeing an increased level of awareness by producers. They look at their suppliers and their raw materials to make sure they’re testing the materials before they put it into their supply chain.

Also with regulations like FSMA, we see retailers driving food safety and quality systems through third-party certification bodies such as GFSI. Retailers are requiring their suppliers to have effective food safety quality management systems in place in order to do business.  These practices will help to ensure safe food is being supplied to the consumer from farm-to-fork.   

Is Your Company Prepared to Fight Food Fraud and Product Adulteration?

By Maria Fontanazza
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Having the ability to detect and identify contamination and adulteration in product is a top priority for companies, especially when working with foreign suppliers. In a discussion with Food Safety Tech, Craig S. Schwandt, Ph.D., director of industrial services at McCrone Associates, discusses how companies, especially those with limited resources, can use technologies to improve contamination detection to be ahead of the FSMA implementation curve.

Food Safety Tech: From your perspective, what key elements of FSMA will have a big impact on manufacturers and processors?

Craig Schwandt: For U.S. manufacturers, more and more of their ingredients are coming from foreign countries. [Companies] are responsible for reporting to FDA what measures they have taken to assure food safety in all aspects. Participating in the Foreign Supplier Verification Program will be critical to [their awareness of] whether their foreign suppliers are meeting those obligations. That critical element hasn’t been realized yet.

FST: Is navigating the foreign supplier relationship more of a challenge for smaller businesses versus larger companies?

Schwandt: Global companies have the resources to address contamination concerns and can monitor the processing that takes place in foreign countries. It’s the small companies that don’t have the financial resources to be present in foreign countries. There will be many more issues for them to address—are they really receiving product that they’re paying for? Is the testing that is being conducted in foreign countries really meeting the requirements.

FST: What steps can small companies take to ensure they have testing programs in place to meet requirements?

Schwandt: This ties in with the difference between testing and investigational analysis. Testing involves identification methods that are done to ascertain what is present—it might be an elemental concentration basis or an organic molecule basis—but they’re bulk analysis that determines whether the product is meeting the expected composition.

Then there might be components for which there are actionable levels, if the concentration exceeds actionable levels. But with bulk analysis testing methods, they only understand that they have a component in their product that exceeds an action level, and those methods don’t really specify where that component might be introduced into the product. This is where microscopy-based investigational analysis can assist smaller companies with understanding at what point the contaminant might have been introduced into the product. It can be isolated in individual particles, establishing a forensic pathway for stage of the process in which the contaminant might have been introduced.

FST: Can you expand on the technologies and methods that can be used to detect fraud or adulterated product?

Schwandt: In the case of intentional adulteration and fraud, current technologies include ultrahigh pressure liquid chromatography, liquid chromatography, and mass spectrometry, and the food industry is doing a great job of using them.

In the case of intentional adulteration or fraud, the level of adulteration has to be fairly high, otherwise there isn’t an economic incentive to adulterate it. A great example is with pomegranate juice—if you’re going to intentionally adulterate pomegranate juice with grape juice to cut it down, a fairly large percentage of the final juice will be grape juice in order to make that intentional adulteration process economically motivating. It’s not really so difficult to identify it with [current] technologies.

Where the technologies need to be improved is in instances in which there might be more unintentional adulteration or contamination at trace levels:

  • When there are solid phase particulate contaminants, use of microscopy-based methods (which isn’t new technology) where you isolate the contaminant particles of interest; they occur at trace level. Because we isolate them from the matrix, we can analyze them and [detect] if there were metal particles from processing machinery; we can identify them to the alloy level and give clients a way to trace back to what part in the process stream those particles may have originated.
  • Likewise, Liquid chromatography and mass spectrometry, especially for pesticide residue analysis, will be increasingly more valuable using the QuEChERS program FDA has outlined for quick, safe, reliable and easy analysis of trace contaminants in food products.

FST: What factors are contributing to under-use of microscopy-based methods?

Schwandt: I think the expensive–instrument vendors would like you believe it is as simple as pushing a button to receive your complete quantitative answer. In many cases, the instruments, even though they might be designed with the best intentions, actually do require expert chemists to use them for complete success. There’s a push on the part of instrument manufacturers to provide instrumentation that they sell as providing the complete answer. And there’s a willingness in the food industry to believe it would be as simple as putting a less-skilled person in front of the instrument to run the analysis, push the button, and get the answer, as opposed to hiring an analyst with a lot of expertise.

FST: What industry partnerships/collaborations are essential in testing and analysis?

Schwandt: The partnerships are productive in this area when they’re between production and quality assurance branches of companies and third-party laboratories that can offer niche solutions and third-party verification.

Compliance Deadline for ObamaCare’s Menu Labeling Rule Extended One Year

By Maria Fontanazza
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FDA gives establishments another year to comply with the controversial rule.

Whether it was Congressional pressure or the heat felt from large retail businesses and industry associations, FDA decided to extend the date for compliance with the menu labeling rule by one year. The final rule, “Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments”, was published on December 1, 2014 with the effective compliance date originally set for December 1, 2015. As announced in a Federal Register notice last week, covered establishments now have until December 2016 to make sure they comply with the requirements.

“The FDA agrees additional time is necessary for the agency to provide further clarifying guidance to help facilitate efficient compliance across all covered businesses and for covered establishments to come into compliance with the final rule,” said Michael Taylor, FDA deputy commissioner for foods and veterinary medicine, in an FDA notice.

“The final rule requirements are intended to ensure that consumers are provided accurate, clear, and consistent nutrition information for foods sold in covered establishments in a direct and accessible manner to enable consumers to make informed and healthful dietary choices.” Source: Federal Register

“Covered establishments” are restaurants or similar retail food establishments that are part of a chain and have 20 more locations that conduct business under the same name and offer the same menu items. This can include individual franchises. 

Since February, FDA has received four requests for an extension of the final rule’s compliance date. These concerns, which were submitted by a large retailer and industry associations, stated that there wasn’t enough time to fully implement requirements. The requests also detailed the extensive steps involved in compliance, which include:

  • Developing software and information systems that provide nutritional information
  • Training staff
  • Rolling out standard operating procedures
  • Developing and installing updated and consistent menus (across retail chain operations)

FDA plans to issue a draft guidance next month that will answer questions it has received about complying with the rule. The agency will also offer educational and technical help to businesses covered under the rule and will work with state, local and regulatory partners to support nationwide compliance.

Animal Feed Industry: Steps to Success to Meet FSMA Requirements

By Maria Fontanazza
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As industry awaits next month’s final rule on preventive controls for animal food, companies in the animal feed business must be prepared for the changes, especially as it relates to having an aligned system with HACCP principles. In a Q&A with Food Safety Tech, Victor Muliyil, food technical project manager at SGS SSC North America, and Mary Williams, a quality assurance and regulatory affairs expert at Land O’Lakes, Inc, discuss where companies should be looking for gaps in their systems.

Food Safety Tech: What critical changes does FSMA introduce to the animal feed industry?

Victor Muliyil: FSMA introduces the primary change that all feed manufacturers must have a feed safety hazard control program that is in line with HACCP principles. Hazards likely to occur must be identified and controls implemented; and [although] hazards related to medications and prohibited material must still be controlled, the responsibility is on the manufacturer to identify all hazards and controls. The focus is on prerequisite programs, not just on critical control points.

In addition, feed industry recalls can now be mandated by FDA, not just recommended. HACCP certification is not mandated by FDA, but several feed and food industry customers are looking for competent independent audit and certification of feed safety control programs. Trained internal auditors are required to verify the system. Traceability is required to the next level of distribution, as well as backward to key ingredients such as medications.

Mary Williams: Food industry leaders must now show they have “planned to work safely,” and this plan must be written down with documented evidence of training. This is a fundamental shift in approach, as FSMA indicates that all feed manufacturers must control feed safety hazards consistent with principles many of us have learned in HACCP. This speaks to prevention vs. reaction, so the prerequisite programs as a foundation must be in place first. This is a time of unprecedented change in the U.S. Food/Feed industry plus global supply chains that are expanding. While it is widely accepted that zero risk is unattainable, the approach that companies take to prevent having an issue, and to prepare for efficient and effective response in the event of a problem is seen as critical.

Product Safety Culture must be leadership driven and reinforced and furthermore, a strong product safety culture is a “choice”.  Leaders of an organization set the tone and must proactively reinforce the expected outcome because it’s the right thing to do, not just because it is the newest food safety law.

While many feed companies are moving toward HACCP certification, it is not mandated by the FDA.  Regardless of whether you build a HACCP plan or a Food Safety Plan, it is important for feed/food companies to start now. The cGMPs, new GMPs and most FSMA requirements are generally understood thus having more time to live and practice the programs implemented allows time for adjustments.

FST: Regarding GFSI certification, in what areas are companies in the animal feed industry the most under-prepared?

Muliyil:  Management commitment, understanding and communication are key. Better training is needed to understand feed industry specific hazards and realistic controls. Currently, internal auditing is not very thorough and must be more structured. Corrective actions are not followed through to gauge effectiveness and are often not documented in adequate detail. Finally, validation is not well understood, nor is there specific guidance on this topic.

Williams: Management does not always clearly understand the need and requirements of “Management Commitment”.  It requires active and visible participation at all levels of management. Managers must “walk the walk” and “talk the talk”.  It may also require an investment in resources such as staffing, capital improvements, and training, to name a few. Management commitment is essential to support the development of a strong product safety culture. Failures in product safety culture increase the potential risk of outbreaks and deaths from foodborne illness.

The skills needed in the industry to meet these new expectations are different than what we needed before. It is not enough to just adopt new standards.  We have to train and educate those who implement them.

We need to train for behavior – what do we want the trainee to be able to do? The training needs to be clear and practical. In addition, we need to educate for increased knowledge across the employee base.  Don’t just send the managers and supervisors to HACCP class or auditor training, make sure we educate a multi-disciplined team including production employees.

Continuous improvement is an everyday concept and involves having a strong corrective action/preventive action program. Often deficiencies are corrected quickly, but not prevented over the long term, and this requires increased due diligence.

FST: Are companies with FSSC 22000 certification more prepared for the preventive controls rule?

Muliyil: FSSC 22000 is one of the GFSI benchmarked schemes that offer effective integrated food safety management, covering:

  • Specific controls and scheme criteria for animal feed and pet food
  • Global buy-in and adoption by many of the world’s leading feed and food manufacturing companies
  • A top-down focus, including defined roles for management, requirements for policies and regular management review
  • Prerequisite programs focused on hazard control, in line with HARPC and FSMA
  • The HACCP system approach to structured food safety control, focused on medications & prohibited material control
  • Traceability from suppliers through to customers
  • Communication:External: Consumers, customers, service providers, suppliers, associations and regulators.
    • Internal: Within a company and between all elements of the system
    • Internal audit of the entire food safety management system and follow up
  • Regular system updating to maintain rigor

Williams: A company certified in FSSC 22000 or one of the other GFSI benchmarked standards has implemented Codex HACCP and hygiene principles in their foundation programs. These same HACCP and foundation programs overlap with the requirements in the preventive controls rule and will support compliance to FSMA.  It will be important to review all the FSMA requirements to ensure all elements are effectively covered in the current company program.

FSSC 22000 requires annual recertification and an annual self-audit. These two elements of review ensure that internal and external eyes are always looking for program compliance before a failure occurs.  These are solid “prevention” elements that support FSMA compliance as well.

Cristin Singer, assurance partner at McGladrey LLP

Security Risks, Protecting Reputation Among Concerns of Food & Beverage Companies

By Maria Fontanazza
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Cristin Singer, assurance partner at McGladrey LLP

In a recent survey of food and beverage executives, nearly half of respondents named product quality as a major risk area and cited product recall capabilities as a priority. However, only about one-third of executives expressed confidence in their companies’ current safety and recall strategies.

Cristin Singer, assurance partner at McGladrey LLP
Cristin Singer, assurance partner at McGladrey LLP

“Mitigating [product] risks starts with tone at the top and leadership within a company,” says Cristin Singer, assurance partner with McGladrey, LLP. “Companies have a strong focus on the diligence associated with quality (especially among employees involved in testing) and building long-standing, trusted relationships with suppliers and vendors.”  Many companies are also increasing their testing of imported products and making sure that their partners are familiar with the cultures of the regions from which they import goods as part of their risk mitigation strategy.

The Food and Beverage Industry survey, conducted by McGladrey, involved 179 executives, owners, and decision makers from food and beverage companies with annual revenues between $10 million and $1 billion.

Respondents consisted of retailers (51.1%), manufacturers and processors (34.8%), distributors (26.4%) and growers (6.7%). Figure courtesy of McGladrey.
Respondents consisted of retailers (51.1%), manufacturers and processors (34.8%), distributors (26.4%) and growers (6.7%). Figure courtesy of McGladrey.

Product Recalls. Some companies are basing their product recall strategy on where they actually fall within the supply chain. “I’ve found that when a company feels that they serve as a middle-man distributor, and depending on the contractual relationship with the co-packer, they look to the processor or co-packer to manage the recall process,” says Singer, who is also a member of McGladrey’s national consumer products team.  In addition, Singer sees a focus on due diligence related to co-packers and suppliers to ensure they have proper certification, and processes and procedures in place to manage risks and recalls.

Ability to respond to reputation risks

Wage and Labor. Food and beverage companies are also facing a variety of wage and labor issues. Larger companies expressed concern with increased labor costs and attracting technical talent; smaller companies are more worried about minimum wage legislation labor costs, and retaining skilled labor workers on the shop floor. Executives also cited that minimum wage legislation and the Affordable Care Act could pose challenges over the next year.

Data Security. As more companies adopt platforms that store sensitive data, the security of these systems is important. Yet only about 42% of executives are very confident that their data and systems are secure from authorized access (about 50% are “somewhat confident”). Improving employee security protocols and providing training, involving data security consultants, and conducting due diligence on vendor data security are among the actions that companies are taking to enhance the security of their platforms. “If there’s a data breach, a lot of sensitive information could be put out there, including product formulations, intellectual property, and employee data (social security numbers or healthcare data),” says Singer.  “Initially a lot of companies on the retail side were focusing on data security. Now we’re educating our clients, especially those on the distribution, processing or manufacturing side. All levels of the supply chain are at risk.”

Enrichment Time for Salmonella

By Food Safety Tech Staff
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In less than two weeks, FDA is holding a Demo Day at the Center for Food Safety and Applied Nutrition in Maryland. The agency will be awarding $500,000 to the team that can develop a technique or technology that creates “significant improvements” in the speed at which FDA can detect Salmonella in fresh, minimally processed produce.

A few months ago, Capt. Palmer Orlandi, Ph.D., senior science advisor at FDA’s Office of Veterinary Medicine, describes exactly why FDA is offering such a hefty prize. It can take between three and five days to detect Salmonella in product, and with full serotyping, it can take as long as two to three weeks to obtain results.

FSMA Final Rules Almost Here, Guide to GFSI

By Food Safety Tech Staff
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With a host of mandatory requirements under FSMA means, businesses may want to consider GFSI certification.

The first FSMA deadlines are now two months away, and manufacturers may wonder how and where GFSI certification ties into increased regulation. First, what are some of the main differences between GFSI and FSMA? GFSI is seen as more global, while FSMA is more US-focused. Of course, the final FSMA rules will require mandatory compliance, and GFSI is voluntary. However, GFSI certification is recognized among major domestic and international retailers, so compliance with a GFSI-recognized scheme is an important part of a company’s food safety program.

The Food Safety Consortium Conference features a GFSI Services & Compliance track. With increased regulatory demands under FSMA, speakers will discuss the role of food safety certification systems. A GFSI-certified facility is one step closer to compliance with FSMA and may be held in higher regard by FDA from an auditing and inspection standpoint versus a business that has not opted to obtain certification.

Obtaining GFSI certification provides several benefits to the food industry, according to a recent TraceGains blog about the GFSI journey, including:

  • Reducing duplication of audits
  • Creating a comparable audit approach and outcomes
  • Enabling continuous improvement and customer opportunity for GFSI-benchmarked companies
  • Enhancing trade opportunities
  • Gaining cost efficiencies throughout the supply chain
  • Increasing competitiveness in the global market

Several food safety management schemes are recognized by GFSI. Among them is FSSC 22000, which touts the certification of more than 10,000 businesses worldwide. This year’s Food Safety Consortium also includes the first FSSC 22000 North American Harmonization Day on Tuesday, November 18. The meeting will provide a technical update of FSSC 22000, along with current scheme and future plans for expanding scopes and preparing for GFSI benchmarking.

House Votes to Repeal COOL for Beef, Pork and Chicken

By Maria Fontanazza
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The debate over country-of-origin labeling isn’t over yet.

In a 300-131 ruling, the House voted to pass the highly contentious COOL Amendments Act of 2015 (H.R. 2393) last week. This means that country-of-origin labeling will no longer be required for beef, pork and chicken. Consumer advocacy groups such as the Consumers Union (a division of Consumer Reports) are clearly unhappy about the passage of the bill, while industry associations such as GMA immediately applauded the decision.

“Without these changes to U.S. COOL rules, U.S. food and agricultural sectors could face financial losses in the billions when Mexico and Canada impose WTO authorized retaliatory tariffs as early as this summer,” said Denzel McGuire, executive vice president for government affairs at GMA, in a statement. “The financial impact of these tariffs will be felt even before they are implemented because the targets of these retaliatory tariffs will begin to experience a substantial drop in export sales almost immediately due to supply chain disruptions. A wide array of product categories will be impacted by these tariffs.”

On the opposing side, the Consumers Union states that the U.S. can avoid trade sanctions. According to the advocacy group, 90% of Americans surveyed want country-of-origin labeling on the meat they purchase. “No penalties have yet been accepted by the WTO, and the U.S. may still avoid trade sanctions by negotiating a settlement with Canada and Mexico,” said Jean Halloran, director of Consumers Union’s Food Policy Initiatives, in a letter sent to the House of Representatives, urging them to vote against a repeal. “Even if retaliation occurs, it is not likely to begin for many months, during which time the United States could develop and implement a solution preserving consumers’ access to country-of-origin information.  Contrary to statements made by the proponents of H.R. 2393, a settlement with our trade partners would be the true “targeted response” to the WTO ruling.”

Now it’s up to the Senate.

Does your product contain PHOs? FDA says they're not GRAS.

Partially Hydrogenated Oils Not GRAS, Says FDA

By Maria Fontanazza
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Does your product contain PHOs? FDA says they're not GRAS.

FDA has made it official. The main source of artificial trans fat in processed foods, partially hydrogenated oils (PHOs), are not generally recognized as safe (GRAS) for use in human food. The agency is giving food manufacturers three years to comply. Companies can either reformulate products without PHOs and/or petition FDA to allow specific uses.

Does your product contain PHOs? FDA says they're not GRAS.
Does your product contain PHOs? FDA says they’re not GRAS.

FDA is defining PHOs as “fats and oils that have been hydrogenated, but not to complete or near complete saturation, and with an iodine value greater than four”.

“This determination is based on extensive research into the effects of PHOs, as well as input from all stakeholders received during the public comment period,” said Susan Mayne, Ph.D., director of the FDA’s Center for Food Safety and Applied Nutrition, in an FDA press release. Manufacturers have been required to indicate the presence of trans fats on product labeling since 2006. The agency estimates that between 2003 and 2012, consumption of trans fat decreased by nearly 78%, and attributes this drop to labeling requirements and consumer awareness. For the past decade, the Institute of Medicine has recommended limiting trans fat consumption.

“The FDA’s action on this major source of artificial trans fat demonstrates the agency’s commitment to the heart health of all Americans,” stated Stephen Ostroff, M.D, acting commissioner of FDA. “This action is expected to reduce coronary heart disease and prevent thousands of fatal heart attacks every year.”

After issuing its notice in November 2013 that PHOs were not GRAS, FDA received more than 6000 comments in response to this tentative determination. According to the Federal Register notice, the majority of comments from industry, trade associations, advocacy groups, health professionals, and government stakeholders were in favor of FDA’s tentative determination. Those who expressed dissent cited the agency’s scientific analysis as well as its potential effect on trade, taxes, and the potential that it could lead to bans on other substances; some provided alternatives to dealing with the issue of trans fat in food.

Scanning electron micrograph shows a colony of Salmonella typhimurium bacteria. Photo courtesy of CDC, Janice Haney Carr

State of Salmonella: Technology and Industry Trying to Reduce Rates

By Maria Fontanazza
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Scanning electron micrograph shows a colony of Salmonella typhimurium bacteria. Photo courtesy of CDC, Janice Haney Carr

By 2020, the CDC has targeted a reduction in Salmonella cases at 11.4 per 100,000 people (last year’s rate was 15.4 per 100,000). Considering that the number of cases has not declined in the past 10+ years, regulators and industry will need to work together more closely on utilizing methods and technologies that provide effective pathogen detection.

Scanning electron micrograph shows a colony of Salmonella typhimurium bacteria. Photo courtesy of CDC, Janice Haney Carr
Scanning electron micrograph shows a colony of Salmonella typhimurium bacteria. Photo courtesy of CDC, Janice Haney Carr

It is a well-known fact within the food safety industry that Salmonella is the second most common foodborne illness in the United States, and the bacteria comes in first place in the category of foodborne illnesses that lead to hospitalization or death.  Unfortunately, there has been no change in the number of confirmed infections between the 2006-2008 period and last year, according to the CDC’s Foodborne Diseases Active Surveillance Network (FoodNet) 2014 Food Safety Progress Report. 

“The major threat Salmonella poses is that its public health impact has remained largely unchanged despite many years of regulatory oversight and technological improvements,” says Evan Chaney, Ph.D., senior manager, scientific affairs at Roka Bioscience. “Reducing the existing public health burden of Salmonella is a complex challenge that will require new and innovative thought, research, and technological developments or processes.”

Each year Salmonella makes its way into the food supply through a variety of sources, sickening more than 1 million people in the United States and costing the country nearly $3.7 billion, according to the USDA. Although it is most commonly found in contaminated animal-derived products, the level of serious outbreaks over the past few years is cause for concern, as the bacteria have appeared in processed foods such as peanut butter and fresh produce, including cucumbers, cantaloupes, alfalfa sprouts and jalapeno peppers.

USDA’s Food Safety and Inspection Service (FSIS) proposed federal measures in January to lower the rate of Salmonella in poultry, including a pathogen reduction performance standard for chicken parts, and ground chicken and turkey. FSIS began the sample project for raw chicken parts in March (only for firms that produce more than 1,000 lbs of chicken parts daily) and a verification testing program for poultry carcass inspection, using a moving window of sampling results, in May (view the full Federal Register notice).

Technologies Taking Down Salmonella

Providing rapid pathogen detection for Salmonella in less than 24 hours has been a priority for industry. Companies want to both prevent contaminated foods from entering the market as well as ensure that products can be quickly tested so that they are not sitting in a warehouse for days awaiting results. With this focus comes a need to provide testing in the processing environment.

“I think we will see an increase in testing related to the Food Safety Modernization Act, and there’s a trend toward environmental testing as opposed to finished product testing,” says Meredith Sutzko, Product Manager, Food Pathogens of Romer Labs North America. “Processors are looking to identify contamination very early in the process. To do that, they need simple and cost-effective methods, especially ones that will deliver a fast time-to-result and can be used at the production facility so they don’t have to wait to obtain test results.”

From enzyme immunoassays (EIA) and enzyme-linked immunosorbent assays (ELISA) to PCR assays, there are a large variety of established testing and identification technologies on the market. However, in taking a different approach to lowering the risk of Salmonella from entering the market, companies can employ limits testing as an additional tool to verify process control within a production shift. Salmonella limits testing is a semi-quantitative method that provides a “positive” or “no-go” result based on initial contamination levels of a sample, and does so within a day.

Limits testing provides a semi-quantitative approach to lowering Salmonella levels. Image courtesy of Roka Bioscience
Limits testing provides a semi-quantitative approach to lowering Salmonella levels.
Image courtesy of Roka Bioscience

“A key difference in this testing approach is the utilization of a pathogen test as a means of process control or intervention, an example of a tool utilized in a new manner,” says Chaney, adding that in most cases, pathogen testing is conducted on finished product or on lots of product in concordance with COA requirements. While it is important to provide results that indicate both qualitative (presence or absence) and quantitative (estimates concentration), having insight into actual concentration levels provides another layer of risk mitigation. “We need tools to help us understand what Salmonella loads are in the system in a rapid manner so that action can be taken. This is the purpose of limits testing.”

As a case example of limits testing being used in the field, Cargill asked Roka Bioscience to develop a limits-based approach for testing its ground turkey for Salmonella. Roka was required to provide Salmonella detection levels at about 1 CFU/g in a 375 g sample size of ground meat in less than eight hours (total time to result). Roka successfully developed the limits application, and Cargill now uses the tool to make product disposition decisions prior to shipping its ground turkey. Roka is also looking at other areas in which limits testing can be used, from the pre-harvest to live production environments.

Calling on industry to push harder to innovate in foodborne pathogen detection, FDA announced its 2014 Food Safety Challenge last fall. The agency is offering a hefty prize—$500,00—to the team that can develop a technique or technology that creates “significant improvements” in the speed at which FDA can detect Salmonella in fresh, minimally processed produce. The finalists, announced last month, have received $20,000 to further develop their concepts and are being mentored by FDA in food safety and pathogen testing.

Technology contenders for the challenge include:

  • A handheld magnetoelastic biosensor and surface-scanning detector that can be passed over food to detect surface contamination. The portable device can be used both in a process facility as well as remote locations in which produce is being harvested and delivers results in minutes, according to the team’s leader, Bryan Chin, director of the Auburn University Detection and Food Safety Center.
  • Patented high-throughput technology for capturing Salmonella in large sample volumes. Developed by UC Davis School of Veterinary Medicine and scientists from Mars, Inc., the test uses fluidized bed technology to detect bacteria in less than four hours and presents potential for larger food processors. View the UC Davis video
  • DNA aptamer-magnetic bead sandwich assay, for use with a handheld florescence reader. Developers of the assay are from Pronucleotein, Inc. and Xgenex
  • Method for concentrating salmonella to detectable levels using automated microfiltration, developed by Purdue University.
  • Portable system for multiplexed detection of foodborne pathogens in microfluidic biochips through isothermal DNA amplification and electrical detection, developed by University of Illinois and Purdue University.

On July 7, FDA is holding a Demo Day at the Center for Food Safety and Applied Nutrition in Maryland where the finalists will present their refined concepts to judges from the FDA, USDA, and CDC, and a live audience. The winner of the Food Safety Challenge will also be announced sometime next month.