By Tim Curran

High-profile food recalls and food-borne illnesses continue to keep food safety top of mind. Yet, many in the industry are still struggling to put the best practices we’ve learned over the years about how to properly secure our global food chain into practice. Put simply: The focus needs to be on prevention rather than reaction.

Food safety procedures must be strengthened across the board to meet increasing regulatory pressures and prevent massive recalls and illness outbreaks. FSMA puts the principles of prevention into law. The first major update of federal food safety laws since 1938, it was signed into law by President Obama at the start of 2011. After years of debate, it is now finalized and implementation can begin. The objective of FSMA is to ensure that the U.S. food supply is safe by shifting the focus from reaction to prevention. Now, who can argue with that?

FSMA also pushes the FDA to extend beyond its traditional reactive role. For the first time, the FDA has the power to stop unsafe and possibly contaminated food from entering the food supply.

Let’s take a quick step back so we can explore how to best put it into action. FSMA is made up of five primary provisions:

Preventive controls
Inspection and compliance
Imported food safety
Response
Enhanced partnerships

I’d argue that the first provision is the true heart of FSMA: Prevention. The first provision focuses on preventative controls and provides a framework for an effective food safety program. In FSMA, this is broken into five key parts, including hazard analysis, preventative controls, monitoring, corrective action and verification. But what does that mean to you? You can best comply with these requirements by implementing better visualization, documentation and communication tools. Let’s walk through each section and the types of tools that you should consider.

Hazard Analysis. Most companies have strong HACCP plans in place, taking account food safety hazards at all stages of production. Risk assessment and risk management must be taken into account and critical control points defined. However, to manage this going forward, consider tools that enable visibility into the current and historical situation at those control points to allow your team to see their proximity to each other, as well as to other components in the plant.

Preventive Controls. Preventative controls are also called out as part of the FSMA requirements. This includes food allergen, supply-chain and sanitation controls in place, as well as sound recall plans. Again, critical control points (CCPs) are the key to ensuring your controls are effective. Also, consider trying indicator test points to stay one step ahead! Indicator test points, as advocated by food safety leader, John Butts, are one or more steps removed from your CCPs. By testing in these areas, you can identify possible risk areas before they even reach control points. This enables a much more proactive approach.

Monitoring. Your plant should have a monitoring plan that includes written procedures for monitoring preventive controls and how frequently they should be performed. This plan should take into account zone coverage, randomization, test frequency, test timing and sampling order. Depending on the business and regulatory rules of a plant, testing should include non-food contact and food contact surfaces. In order to ensure that testing is representative of the conditions in the plant, randomization of test points is important. In addition, test frequency and test timing should be defined, and organizations should seek tools that help to automate these business rules.

Corrective Action. Hope for the best, but always plan for the worst. What is your corrective action plan? You must have a written procedure for identifying and correcting a problem. For both your plant and for regulators, a clear record of your plan and that the steps were followed to close out any issues is required. Make sure that the team understands the steps that are required, number of re-tests and any recall requirements. Look for tools that automatically alert the relevant team members of the situation and track response and testing so that you can easily share this level of detail as needed.

Verification. Trust but verify. Having a plan is only half the job. Using your environmental and finished product testing programs to ensure that controls and corrective actions are effective turns your plan into action. Rapid testing technologies keep the time between testing and results tight. Also, communication of verification results keeps the team coordinated around food safety.

The move to more preventative food safety procedures does not have to create massive headaches. Compliance with FSMA will ultimately help your business and guarantee that you are providing safe food for your customers to consume. Many food companies have been implementing these best-practice guidelines for years. Thanks to FMSA, we all now get an easy-to-follow checklist.

Shifting from reaction to prevention makes food safer—and now, it is also the law. The first step is to make sure you have a good understanding of the components. Only then can you find the best tools and technologies to support you. Lastly, make sure that your team is well aligned around the goals and objectives of your food safety program. Together, we can make food safer.

January 18, 2016

FST Soapbox

Open Letter to FDA on Adoption of Systems Approach to FSMA

By Patrick Embwaga

4 Comments

The new FSMA regulations are primarily intended to enhance the protection of public health through promotion of adopting a modern, preventive and risk-based approach to food safety regulation. The general consensus industry-wide is that the new regulations will increase the capacity of firms in the industry to develop effective food safety management system at facility levels that will be effective in preventing distribution of food-related hazards to the general public, which may result in foodborne illness.

There is widespread consensus that the development and implementation of a food safety system whose primary purpose is to prevent the distribution of hazardous product to the general public and hence prevent or reduce foodborne illness is a much more effective and practical approach towards this end. This is especially the case when compared to past approaches, among which many programs were quality control based and focused on end-product testing given the highly fluid and dynamic complexity in the food industry, which is being fueled by technological advancements that occur at the speed of light.

Having stated consumer safety as the primary stakeholder of a facility’s food safety system, there are other secondary stakeholders whose requirements are subservient to the consumer’s health requirements, but they play key roles in determining the architectural structure of the food safety system:

Regulatory requirements. Primarily serve the public and act on its behalf in ensuring that all food products distributed in the market are safe for consumption. However, the regulatory requirements have their own innate requirements (i.e., the uniformity of the structure of a food safety system) at the most basic level for the purposes of compliance, which enables a harmonized structure that conveniently lends itself to a uniform approach in the inspection of facilities by FDA agents.
Organizational requirements. There are existential risks to an organization should a facility ship out contaminated product, as can be seen from the recent cases widely reported by the media. These range from market share reductions to rattled shareholders, and to employees, it becomes a job security issue. In fact, this is one of the key points I always bring out during trainings: The consumer is the ultimate boss, and if the consumer complains, it’s bad for our jobs as food manufacturers. If they are outright sickened/angry/mad by our job performance, we should expect the pink slips (I’m sure a number of employees at the Blue Bell Creameries will support this opinion).

From a regulatory requirement perspective, uniformity is a key aspect of the requirements, as can be inferred from regulatory text on the preventive rules, which describe the fundamental elements that must be implemented by a facility in order for it to be compliant with FDA registration. The lifecycle of regulatory requirements are long term—the last time comprehensive changes were conducted on cGMPs was in the mid-1980s. And hence the analytical/reductionist approach of focusing on food safety at the facility level is complementary to its enforcement strategy (i.e., facility-based registration and inspection).

From the organizational perspective, given that the food safety system serves an existential purpose to the business, organizations are leveraging the best available resources to endure its proper design and implementation, including employing the use of the latest available technologies. From the organizational perspective, the organizational requirements are highly dynamic and often tied to consumer and market trends. And as such in most corporate organizations, the food safety system adopts a holistic approach, whereby plant facility food safety systems are often nested within larger hierarchical corporate food safety systems. One of the fundamental reasons for this holistic set up is to enhance efficiency of these programs, especially given their key functional roles in mitigating or preventing organizational risks that may be presented through distribution of contaminated product.

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Maria Fontanazza, Editor-in-Chief, Innovative Publishing Co. LLC

January 10, 2016

From the Editor’s Desk

Will It All Come Tumbling Down for Chipotle?

By Maria Fontanazza

1 Comment

As of late, the problems for Chipotle have been endless. 2015 was a year of several Salmonella, norovirus and E. coli outbreaks for the restaurant chain. With the first full week of the new year wrapped up, 2016 is off to perhaps an even rockier start, with news of the company being hit with both a class action lawsuit and a federal grand jury subpoena.

Company stockholder Susie Ong filed a civil complaint against Chipotle on January 8, stating that the company made false or misleading statements and failed to disclose that its “quality controls were inadequate to safeguard consumer and employee health.” Filed in the U.S. District Court for the Southern District of New York, the complaint calls out a norovirus outbreak that occurred in August in Simi Valley, California; a Salmonella outbreak in Minnesota that sickened 64 people; the closure of all company restaurants in Portland, Oregon and Seattle, Washington in November following an E.coli outbreak; and the highly-publicized norovirus outbreak that sickened more than 140 students from Boston College in Brighton, Massachusetts last month.

Ong’s complaint also mentions the federal grand jury subpoena, which Chipotle made public two days prior (January 6) in an SEC filing. Served in December, the subpoena is part of a criminal investigation by FDA and the U.S. Attorney’s Office for the Central District of California into the Simi Valley norovirus outbreak, which sickened about 100 patrons and employees (some reports state that more than 200 people fell ill). Ong’s lawsuit states that health inspectors found “dirty and inoperative equipment, equipment directly linked to the sewer, and other sanitary and health violations” at the Simi Valley restaurant.

With December’s norovirus outbreak in Brighton and the CDC’s announcement that it was further investigating five new cases of E. coli that were reported the month prior, restaurant sales were down 30% for the month, according to the SEC filing. Ong adds up all of these unfortunate events in the lawsuit, stating, “As a result of defendants’ wrongful acts and omissions, and the precipitous decline in the market value of the Company’s securities, Plaintiff and other Class members have suffered significant losses and damages.”

Chipotle has not yet publicly commented on the lawsuit.

Earlier in December, Chipotle called attention to improvements it was making to its food safety program by bringing in IEH Laboratories and Consulting Group to reevaluate its processes in an effort to prevent future outbreaks. Clearly that was not enough.

Food companies take heed. 2016 is off with a bang, and not in a good way. Last week industry was also buzzing about the DOJ’s investigation into Blue Bell Creameries over the deadly Listeria outbreak. FDA and the other federal powers-that-be are making it very clear that negligence will no longer be tolerated (Or should I say, alleged negligence, in this case). Compliance, accountability, and above all, ethical behavior are at the heart of the matter.

Will it all come tumbling down for Chipotle? It remains to be seen whether the company will be able to recover from these issues. And maybe an even bigger question is, who will be next?

December 28, 2015

FST Soapbox

Technology Can Help Food Manufacturers Navigate FSMA in 2016

By Jack Payne

1 Comment

It’s safe to say that 2015 has been one of the worst years in recent history when it comes to food contamination. Everyone from global food manufacturers to major restaurant chains and grocery stores perpetuated or experienced outbreaks of foodborne illnesses like E. coli, Listeria, Salmonella and Norovirus. From farm to fork, the food industry needs to evalutate and improve its processes to deliver the utmost health and safety to consumers.

With FSMA and tougher industry standards in place, there will be much more emphasis on preventative measures—especially for food manufacturers. FSMA establishes a legislative mandate to require comprehensive, prevention-based controls across the food supply to prevent or significantly minimize the likelihood of problems occurring.

Even though most of the regulations affiliated with the FSMA have just gone into effect, or will go into effect in 2016, food manufacturers are already feeling the heat. A recent survey found that the majority (81%) of food manufacturers are experiencing some level of impact from current and impending regulations. Processes pertaining to traceability, supplier and facility audits, HACCP and product recalls are causing the most concern. While most food manufacturers support FSMA’s mission to put prevention at the forefront, the reality is that many aren’t equipped to handle growing compliance demands.

There are still a sizeable number of food manufacturers that manually record their processes for identifying, evaluating and controlling food safety hazards. In fact, more than 30% of food manufacturers document their HACCP plan in this manner.

FSMA Infographic — 58% of manufacturers surveyed are using an in-house system for recording issues as part of their HACCP plan

With FSMA, there isn’t any room for human error. Although technology with track and trace capabilities has been available long before FSMA came into play, obstacles such as complicated interfaces, lack of interoperability and resources deterred wide-spread adoption among food manufacturers. The tide is changing here. Advanced enterprise resource planning (ERP) solutions have built in track and trace functionality that is more intuitive and integrates seamlessly with vital manufacturing execution systems (MES).

FSMA and traceability — Manufacturing execution solutions play a key in helping companies achieve traceability. All figures courtesy of Aptean. View full infographic

Although the FDA does not have the legal authority to require companies to use computerized traceability solutions, implementing track and trace technology is one of the most effective measures a food manufacturer can take when it comes to FSMA compliance. It can help create a more systematic and reliable account throughout the lifecycle of a food product, and also establish preventative measures, including automated product checkpoints and quality tests throughout the supply chain. Ultimately, this gives food manufacturers the opportunity to identify and prevent issues before they become epidemics.

In addition to taking strong measures to prevent contamination, under FSMA the FDA now has authority to initiate mandatory recalls. Although mandatory recalls are anticipated to be rare, food manufacturers should use track and trace technology to make recall preparation routine. When used properly, these tools can pinpoint specifics about a product in real time, streamline quality reporting, and launch mock recalls.

Of course, technology is not only the vessel for improvement—to actually see change, food manufacturers need to take a critical look at their processes and make adjustments. Automating poor processes will only accelerate poor results, therefore approaching FSMA compliance and implementing track and trace technology requires time and strategy.

Ultimately, your company’s reputation is on the line as well as the safety of consumers. Dedicating necessary resources toward compliance planning and technology implementation is always well worth the investment. Many of the companies and suppliers that were in this year’s spotlight for contamination will look back on 2015 with regret because safety wasn’t at the forefront. Let’s learn from the hard lessons they provided and make 2016 the year that food manufacturers win back consumer trust and focus on quality.

Deirdre Schlunegger, CEO of STOP Foodborne Illness

November 30, 2015

Food Safety Culture Club

An Inspiring Evening

By Deirdre Schlunegger

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November 17 was an inspiring evening at the Food Safety Consortium! Thanks to the generosity of Food Safety Tech and Chemstar, a number of friends were able to join STOP Foodborne Illness in celebrating two of its Food Safety Heroes.

We honored Nancy Donley, former STOP spokesperson with the Legacy Tribute award. Since the death of her son Alex, in 1993, Nancy has selflessly advocated for stronger food safety policies and practices. Our other esteemed guest was Frank Yiannas, vice president of food safety for Walmart, a man known for passionately escalating the notion of a “food safety culture.” Frank received STOP’s Industry Advocate Hero award.

STOP Foodborne Illness and Food Safety Heroes

Another highly regarded guest, FDA Deputy Commissioner Michael Taylor, shared his reflections on the magnitude of the evening. Please take a moment to read Taylor’s eloquent and thoughtful words regarding this milestone celebration.

Ron Harrison, Ph.D., Director of Technical Services, Orkin, LLC

November 23, 2015

Bug Bytes

Don’t Welcome Pests into Your Facility This Winter

By Ron Harrison, Ph.D.

4 Comments

Days are now shorter, and temperatures are slowly dropping in most parts of the country. It is the time of year when individuals look to spend a little more time indoors and a little less time outdoors. However, did you know we aren’t the only ones looking for relief from the cold?

Similarly to us, this is the time of year when certain pests look for a nice, warm home to spend the winter months. The downside for food facilities is that they offer everything pests need for survival—food, water and harborage.

In fact, food facilities can face numerous pest challenges during the colder months, including ants, cockroaches, stored product pests and flies. Additionally, the most common and challenging winter pests are rodents. Due to their ability to squeeze through small spaces and adapt to many different environments, they can be a facility’s worst nightmare.

Don't let rats and mice threaten food safety audit scores. Image courtesy of Orkin — Don’t let rats and mice threaten food safety audit scores. All images courtesy of Orkin

The presence of rats and mice can lead to food contamination and can threaten your food safety audit scores, reputation and bottom line. Rodents are known carriers of deadly neurological and respiratory diseases like lymphocytic choriomeningitis virus (LCMV) and Hantavirus Pulmonary Syndrome. Ticks, mites and fleas can feed on infected rodents and transmit diseases like pox, plague and typhus indirectly to humans—putting not only employees in your facility at risk, but also customers.

Rodents can be tough to control and are very adaptable at living indoors. Some mice that take shelter inside due to weather can survive indefinitely as indoor mice. In fact, there is a possibility rodents may have already taken shelter by now, so it’s important to talk with your pest management professional about common areas where rodents may be hiding.

As you winterize your facility, it’s important to keep rodents and other pests in mind. A proactive approach to facility maintenance, as well as an effective Integrated Pest Management (IPM) program, can help keep pests out and your food product and business secure.

The following tips will help keep your facility off pests’ radars this winter.

Stay Vigilant in Monitoring for Pest Activity

Vigilant, ongoing monitoring is a cornerstone of an effective IPM program. With this strategy in place, there are many tactics you and your staff can use.

Identify “hot spots”. Work closely with your pest management professional to identify the most common places pests reside in around your property. These can include loading docks, utility rooms, employee break rooms, dumpsters and trash cans, storage rooms and behind any heavy, immobile pieces of equipment. By identifying these hot spots, you’ll be able to prevent pests from entering your facility.
Involve your employees. Educate your staff on the pests themselves, as well as the conditions that attract them, and encourage your employees to report any signs of problems. Utilize a reputable pest management company to provide your employees with this training—many providers offer training at no extra cost.

Look for gaps and fill them to keep those pesky critters out!

Strengthen Your Facility’s Perimeter

While certain pests can hitch a ride into your facility via shipments and even on people, the biggest pest threats start on the outside. With this in mind, you can take fight pests outside by strengthening your perimeter.

Look for and fill cracks and crevices. Crawling pests like to creep inside through small openings. Additionally, rodents can squeeze through holes the size of a quarter, mice through dime-sized openings that create gaps barely noticeable to the human eye. Regularly inspect the exterior of your facility for any cracks that may develop and pay close attention to openings that can form around pipes and utility penetrations. Don’t forget to seal any holes in exterior walls with water-resistant sealant and steel or metal mesh.
Eliminate clutter and attractants. Rodents may burrow or live up to 100 yards away from your structure, and flies, ants and cockroaches are also on the hunt for easy meals that can often be found on the property. Keep trash handling areas free of clutter, and clean up any uncovered garbage or standing water outside. Also, work with your waste management company to ensure they clean and switch out dumpsters regularly.
Keep landscaping off your building. Pests will often use vegetation as staging and feeding sites. Keep trees trimmed and plants at least 12 inches from your building, and remove leaves quickly so pests cannot use them for cover. As an extra step, consider installing a two-foot wide gravel strip around the perimeter of the building. Think of these exclusion techniques as digging a moat around your castle.
For rodents, bait stations can be set outside. Work with your pest management provider to place tamper-resistant bait stations around the exterior of the facility. However, do not place the stations near doors or entryways, as they can attract pests into the facility. Be sure to maintain an up-to-date map of bait stations and record activity at each station to determine the source of rodent pressure and target future treatments accordingly.

Prevent fruit flies by keeping employee break rooms clear of food remnants and tightly sealing garbage cans.

Reinforce Clean Conditions Inside

Once you set up an outside defense against pests, you can double down on your pest management efforts by taking a few proactive measures inside as well. The key to keeping pests from infesting your facility is removing incentives for them to go inside in the first place.

Inspect incoming shipments. When you are not receiving materials, keep loading bay doors closed—make sure the doors close securely so that pests cannot sneak under them. Inspect incoming raw materials, packaging and truck trailers for signs of infestation.
Reduce potential food sources inside your facility. Employee break rooms should be clear of any food remnants, and garbage cans with food and other waste need to be kept tightly sealed.
Monitor the plant floor. Sanitize drains and equipment with an organic cleaner to eliminate the residue that pests can feed on. With colder temperatures, pipes can break or crack, so ensure plumbing is also maintained properly to prevent leakage and property damage. Monitor for spills and clean them immediately, as pests only need a small amount of moisture to survive.

By putting proactive defenses into place, your facility can enjoy the winter seasons with a decreased likelihood of the appearance of unwanted visitors like rodents, ants, cockroaches, stored product pests and flies. Talk with your pest management professional about these steps and other tactics you can put in place to keep your facility safe against overwintering pests and relegate them to the cold.

November 18, 2015

FST Soapbox

Dealing with FSMA’s Documentation Demands

By Randy Fields

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With the signing of FSMA in 2011, wholesaler and retailer executives are now legally responsible for the safety of their supply chains. In addition, FSMA’s focus on prevention and its seven new rules requires retailers and wholesalers to collect, manage and store multiple documents from each vendor for compliance. These documents must be accessible upon FDA request within 24 hours and extend two years back. And here’s the kicker: Senior executives are now responsible for the compliance of their supply chain with FSMA.

At the Food Safety Consortium, Affiliated Foods Midwest (AFM) will talk about their preparation for FSMA compliance and decision to move away from their “home-built” and “highly manual” compliance system, which stored both soft and hard copies of vendor documents. With FSMA rules focused heavily on documenting preventive measures, AFM executive leadership assessed the company’s gaps and determined they needed to be more proactive. John Grimes, director of safety for AFM, estimated that at the start of the company’s journey, about 30% of vendors were non-compliant with the three records they required: Certificates of Liability with specified limits, Hold Harmless forms and W-9s.

“We knew compliance built on trust was not enough and wanted more business documents and regulatory records collected. We also needed to increase compliance, be more proactive, and so we were looking to automate our systems,” explains Grimes.

AFM decided to adopt the cloud-based Compliance Management System to proactively manage both business-related documents and FSMA-related records. Once implemented, the wholesaler’s non-compliance among vendors was reduced by 60% in the first 90 days through proactive alerts, automated exception reporting and focused, personal follow up.

On Thursday, November 19, Randy Fields and John Grimes will discuss “FSMA Compliance Really Starts With Knowing Your Supply Chain” at the Food Safety Consortium. LEARN MORE“With our prior system I could find a requested document within 24 hours, but with the cloud-based compliance management system, I can pull it up and instantly share it with an FDA agent even before they have a chance to leave my office,” says Grimes.

Document management at AFM is now much more proactive vs. reactive. The Compliance Management System automatically sends alerts to Grimes and the vendor when documents are missing, when insurance limits are too low, or when a document is due to expire. The system enables AFM to proactively manage more documents by vendor than ever before.

The active approach that our staff enables its customers to take in managing compliance is really its differentiator. Each customer is provided with a dedicated team to reach out to their vendors to speed enrollment and quickly address their compliance issues.

According to Grimes, as more retailers and wholesalers adopt this type of system, the vendor community will move more quickly to embrace solutions that will help them comply with FSMA.

November 16, 2015

FST Soapbox

Fighting the Reality of Food Fraud

By Jeff Moore, Ph.D.

2 Comments

Economically motivated adulteration (EMA) of food, or food fraud, has been estimated to cost the food industry $30–40 billion per year. The 2008 incident of melamine adulteration of milk powder has cost billions of dollars to companies and invaluable loss of consumer confidence. Even more significant than the economic cost or loss of confidence, the impact on public health was enormous. An estimated 290,000 consumers were affected with more than 50,000 hospitalizations including at least six deaths. There is also collateral damage caused by incidences of EMA, including the loss of confidence in government regulatory systems around food safety. Although major incidents like the melamine scandal happen infrequently, food fraud commonly occurs under the radar. According to a 2014 report by the Congressional Research Service, it is estimated that up to 10% of the food supply could be affected by food fraud Thus, the costs of fraud food are borne by industry, regulators and, ultimately, consumers.

Attend the Food Safety Supply Chain Conference, June 5–6, 2017 in Rockville, MD | LEARN MOREFood fraud is not a new phenomenon. During the time of the Roman Empire, Pliny the Elder wrote in Natural History about the adulteration of wine, bread and pepper, and tracked the fluctuation of their prices with the appearance of adulteration. In Medieval Germany, the adulteration of saffron was such a problem that the Safranschou Code was enacted, which described standards for saffron and allowed convicted adulterators to be executed.¹ When there is an opportunity for economic gain, adulterators tend to come out of the woodwork.

As recently as the 1980s, food fraud was mostly an event confined to local markets. In 1981 the adulteration of olive oil with an industrial lubricant injured thousands and killed hundreds, but because the oil was not widely distributed, the primary effects were limited to Spain. Similarly, when apple juice adulteration occurred in the United States in the 1980s, the consequences were basically confined to the United States.

However, with the increasing globalization of the food supply chain and freer movement of foods and ingredients among countries, the opportunities for food fraud not only increased, but the consequences also now more easily have a global impact. By the late 1990s, the global consequences of food fraud became more evident with the contamination of fats intended for animal feed with industrial oils containing PCBs and dioxins. This scandal, which started with an oil recycler in Belgium, led to massive recalls of products throughout Europe and concerns about contaminated products reaching the United States. The impact of this episode arguably changed the food safety environment in Europe and led to the formation of the European Food Safety Authority. Likewise, the fallout from the adulteration of wheat gluten with melamine in 2008 likely contributed to the passage of new food safety legislation in the United States, including FSMA.

FDA has always acted against food fraud whenever there was an indication of public health hazards. With the passage of FSMA and the Preventive Controls for Human Food rule (published in September 2015), the agency has come full circle to its roots with Harvey W. Wiley, M.D. and his famous Poison Squad. Dr. Wiley formed his famous group to go after adulterators of foods. The Poison Squad was famously known for their willingness to consume suspect foods to test for adulteration. FDA’s history of Dr. Wiley states that “In the 1880s, when Wiley began his 50-year crusade for pure foods, America’s marketplace was flooded with poor, often harmful products. With almost no government controls, unscrupulous manufacturers tampered with products, substituting cheap ingredients for those represented on labels: Honey was diluted with glucose syrup; olive oil was made with cottonseed; and “soothing syrups” given to babies were laced with morphine. The country was ready for reform…” While the opportunities for fraud have not changed, luckily we no longer have to rely on human volunteers to detect adulterated food.

The new Preventive Controls rule published in September addresses EMA when there is a reasonable possibility that adulteration could result in a public health hazard. Companies are required to conduct a written hazard analysis, which should include hazards identification and evaluation. Companies are expected to identify “…known or reasonably foreseeable hazards that may be present in the food…The hazard may be intentionally introduced for the purposes of economic gain.”[i] While companies were previously expected to be knowledgeable about microbiological hazards in their products, it appears that they now also have the responsibility to be knowledgeable about known or reasonably foreseeable hazards from EMA.

How can organizations identify potential EMA threats as part of hazards analysis? One way is via the Food Fraud Database, which is designed to help answer this question by taking a look into the past. Launched in 2012, the database provides the information necessary to identify ingredients with a past pattern or history of adulteration and the adulterants used—a perfect fit for the EMA requirement in FSMA. The database has more than 140,000 users from 194 countries documented.

After identifying an ingredient with a pattern/history of EMA, companies need to determine whether the ingredient may introduce potential food safety hazards and how to develop a control plan in response. To address those issues, USP undertook a project in 2013 to take a more holistic approach to identifying EMA vulnerable ingredients by looking at factors beyond history. It assembled a group of leading food adulteration experts to develop a first-of-its-kind guidance document that offers a framework for the food industry to help develop and implement preventive management systems to deal specifically with EMA.

The Food Fraud Mitigation Guidance became official in the Food Chemicals Codex (FCC) in September 2015, just as FSMA’s Preventive Rule for Human Food was published. The aim of the guidance is to assist manufacturers and regulators with identifying the ingredients most vulnerable to fraud in their supply chains and how to choose effective mitigation tools to combat EMA. This is a significant leap forward in the battle against food fraud—and a way to get ahead of criminals engaging in EMA. The guidance provides not only a solution to deal with FSMA’s EMA provision, but goes beyond FSMA to help organizations fulfill GFSI requirements to conduct a food fraud vulnerability assessment and control plan.

Thenadier (The innkeeper), in Les Miserables said in the lyrics of Master of the House:

“…

watering the wine and making up the weight

…

Food beyond compare. Food beyond belief

Mix it in a mincer and pretend it’s beef

Kidney of a horse, liver of a cat

Filling up the sausages with this and that”

While deceiving the unwary can seem humorous in fiction, in real-life food fraud can have extremely serious consequences to consumers and everyone involved with the production of safe food. There are multiple large-scale efforts in many regions and countries to address food fraud. The attention that is now focused on food fraud and the development of new tools such as Food Fraud Database cast a bright light that will hopefully make it more difficult for food fraudsters to operate.

Reference

Willard, P. (2002), Secrets of Saffron: The Vagabond Life of the World’s Most Seductive Spice, Beacon Press, ISBN 978-0-8070-5009-5

November 13, 2015

In the Food Lab

FSMA to Increase Role for Food Microbiology Testing Laboratories

By Jacob Bowland

No Comments

As a result of the finalization of FSMA regulations on September 10, 2015, increasing requirements for procedures, documentation and testing will soon be impacting the food industry. The major effects on the food microbiology testing market will come in the form of an increase in the volume of samples that must be processed in accordance with the new FSMA rules, along with an improved emphasis on accurate and complete record keeping. The goals of FSMA are to create a new safety standard across the entire food chain. Increasing food pathogen testing will minimize possible recalls and the probability that dangerous food outbreaks occur.

Food manufacturers’ testing labs and third-party accredited testing labs can meet the demand for increased testing and improved record keeping in one of two ways: Via facility expansion or via implementing new technologies into the laboratory. While facility expansion might be an ideal long-term solution, it will not address the immediate surge in lab demand brought on by the new FSMA requirements, as it takes time to build new laboratories and hire employees. Implementing new technologies in the lab, then, makes the most sense, and where automation can be introduced into traditionally-manual processes, higher throughput may be realized using existing personnel and facilities. Automation further removes human error and improves the quality of the test being performed. The challenge for lab managers will be to objectively look at the current production bottlenecks in their testing operations and determine where technology may be introduced to increase throughput.

In addition to mandating additional testing, the FSMA regulations will require improved lab record keeping, as well as a new accreditation process that FDA will implement. The food testing industry faces the same dilemma that the healthcare industry faced some years ago in migrating from manual files to electronic health records. Lab notebooks have a real purpose in the lab, but their purpose should be more as a backup system to information that is gathered and stored electronically. While Laboratory Information Management Systems (LIMS) have been around for many years, their full potential in pathogen testing has yet to be realized. A properly designed LIMS provides an electronic database that not only aids in the accreditation process, but also allows samples to be traced throughout the testing facility. This allows positive test results to be screened from false positives or false negatives, and points to which equipment or procedures in the testing process need to be improved upon. LIMS technology for recording digital information can also trace user, operation time and performance specifications more accurately than lab notebook-based processes.

In summary, many changes are coming to the food industry as a result of increased regulations, presenting exciting opportunities to develop new products and technologies to alleviate the pain points within testing labs. The industry of food pathogen testing must change alongside the regulatory atmosphere in order to be competitive in a post-FSMA era.

SVP, Food Safety, United Fresh Product Association

November 9, 2015

FST Soapbox

GFSI and FDA’s Preventive Controls: Complementary or Redundant?

By Jennifer McEntire, Ph.D.

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Accreditation, certification, certificates…the structure that supports the third-party audit system can be very confusing! Further, an audit company offers a menu of audits: An audit to their own private standard, audits to several GFSI benchmarked schemes, and perhaps in the future, an “FDA accredited” audit. How do you know which one you need? How do you know which best prepares you for FSMA?

Jennifer McEntire spoke during the session, “Staying Ahead of New USDA and FDA Mandates for Controlling Pathogens in Food Processing” at the Food Safety Consortium conference. LEARN MOREUntil the compliance dates for the Preventive Controls rules pass, food manufacturers really only need to be compliant with good manufacturing practices (GMPs), from a regulatory standpoint. There are some specific audits that evaluate adherence to GMPs, but many companies wanted to take their food safety programs to the next level by demonstrating that they were implementing effective food safety management systems. Certification to a GFSI-benchmarked audit scheme (BRC, SQF, FSSC22000, IFS, etc.) was a primary means to show a commitment to food safety and the demonstration of exemplary programs. With the finalization of the Preventive Controls Rules, FDA is catching up. So how do the FDA requirements compare with the main elements of the GFSI Guidance Document?

Let’s evaluate the extent to which the scope of GFSI aligns with FSMA. In September, the Preventive Controls for Human Food rule was finalized, and the areas addressed within that rule constitute the bulk (although not all) of the topics covered by GFSI (GFSI covers additional areas for which FDA has not yet finalized rules, such as food defense and traceability). The question on everyone’s mind is, “If I’m certified to a GFSI-benchmarked audit scheme, am I compliant with the rule?” The answer is, “You’re probably in way better shape than someone who is not certified.” The reason is, regardless of which GFSI benchmarked audit scheme you choose, your facility will need to demonstrate, through fairly exhaustive documentation, the nature and validity of the programs that are in place, and the proof that those programs are followed day in and day out. FDA is looking for the same thing.

The Preventive Controls rules go beyond strict HACCP in that they require facilities to consider what has historically been termed the HACCP system. This includes programs that may not be critical control points (CCP) per se, but are critical to the safety of the food product. FDA identifies elements of sanitation and allergen control, as well as a supplier program, in this category. If you’re familiar with FSSC 22000, you might call these “operational prerequisite programs”. FDA will want to see how each and every hazard is evaluated to determine if it needs a preventive control, whether that is a traditional CCP or another control. For the most part, this is aligned with the GFSI benchmarked schemes, although some of the language may differ.

When it comes to the implementation of a supplier program, facilities should be aware that FDA’s requirements of such a program are much more explicit than most of the GFSI-benchmarked schemes. Even if the result is the same at the end of the day, FDA inspectors may be looking for companies to follow a fairly structured approach compared to a GFSI auditor.

To further complicate matters, FDA will be finalizing a program for the accreditation of third-party auditors. If an effective private third-party audit system exists, why is FDA adding another layer with its own form of audits (separate from inspections)? The answer lies with Congress, not FDA, as it identified two specific circumstances in which a special regulatory audit would be necessary. One situation is when a facility (or their customer) wishes to participate in the forthcoming Voluntary Qualified Importer Program. The second is if FDA has determined that the food poses food safety risks such that a facility wishing to export that food needs a certification issued by an auditor under this program. In neither case will domestic facilities be audited under this program; this program only applies to foreign facilities and only in very limited instances.

Since the rule and accompanying guidance documents related to accreditation of third-party auditors hasn’t been issued by FDA, it is premature to comment on how these audits will compare to those in use by private industry today.

So with the implementation of new rules from FDA, is there still a market for audits? Absolutely. From a very practical standpoint, FDA won’t be inspecting most facilities on an annual basis, and many private audits are conducted on an annual schedule. Plus, industry typically pushes itself further than regulations, which lag behind. Regulations can be viewed as the floor for expectations, but not the ceiling. Moving forward, we expect audit standards and private audits to become even more stringent and aggressive in terms of promoting the very best food safety practices. But beware, as history has shown us, a certificate is not a guarantee or indication of the ongoing quality of a plant’s food safety system. This is why FDA will not blindly accept that a facility has a favorable audit; regardless of the audit certifications you hold, FDA will still inspect you. That said, depending on the audit, it can serve as a credible certification of a food safety system in a plant and demonstrate to your customers your level of food safety commitment. And poor performance during an audit can find its way to FDA too, since in some instances the agency will have access to the conclusions of the audit and corrective actions taken in response to significant deficiencies identified during the audit. FDA initially proposed that serious issues uncovered during consultative audits conducted as part of the third-party accreditation of auditor program would be shared with FDA, and when audits are used as part of supplier programs, FDA will see how serious deficiencies in audits have been addressed. Be clear on why you are pursuing a particular audit, and take the program seriously. Audits should reflect your food safety culture, not serve as your motivation.

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