Tag Archives: Food Safety Consortium

FDA Reflects on Monumental Effort of FSMA

By Food Safety Tech Staff
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Four years in the making and the FSMA implementation journey has begun. Michael Taylor, deputy commissioner for Watch Part II of Taylor’s speechfoods and veterinary medicine at FDA, describes, from a high-level perspective, what lies ahead in his first public speech since five of the seven rules were finalized. The following video is Part I of Taylor’s speech at the 2015 Food Safety Consortium conference.

Palmer Orlandi, FDA, Food Safety Consortium

FSMA and Laying Groundwork for Data Acceptance in Lab Partnerships

By Food Safety Tech Staff
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Palmer Orlandi, FDA, Food Safety Consortium

Laboratories play a key role in FSMA, including providing data and analytical support, and assistance in surveillance and outbreak activities.

According to Palmer Orlandi, Ph.D., acting chief science officer and research director at FDA, success in the laboratory to support all the activity involving FSMA hinges on the following:

  • Mutual reliance on partners (federal, state and FDA)
  • Data-sharing capabilities (how data is generated and transmitted)
  • Acceptance of lab data

Establishing uniform standards of performance surrounding data quality and sharing, and ensuring that data has been verified and can be trusted lay the groundwork for data acceptance. Orlandi discussed the process of establishing data acceptance criteria at the 2015 Food Safety Consortium conference.

FSMA: Biggest Challenge is Preparation, Outbreaks Still to Come, Says FDA

By Maria Fontanazza
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FDA's Michael Taylor called the journey to FSMA an "amazingly robust process". (Click to enlarge)
FDA’s Michael Taylor called the journey to FSMA an “amazingly robust process”. VIEW VIDEO

FSMA isn’t about zero risk but rather minimizing the hazards, said Michael Taylor, FDA’s deputy commissioner for foods and veterinary medicine at the opening of the Food Safety Consortium conference yesterday. “We have hundreds of thousands of businesses that are subjected to something that they weren’t before,” said Taylor. “The reality is, we’re still going to have outbreaks this year and the next year.”

In his first public speech since three final FSMA rules (on produce safety, foreign supplier verification, and accredited third-party certification) were filed on the Federal Register last week, Taylor shared some of the highs of the formation of the regulation as well as the challenges that are to come with implementation. “Many of us who were involved in the process 20 years ago didn’t imagine we’d get here today,” he said.

Syed Hassan of PepsiCo asks Michael Taylor how FDA will handle the shift in mindset that FSMA requires of agency investigators.
Syed Hassan of PepsiCo asks Michael Taylor how FDA will handle the shift in mindset that FSMA requires of agency investigators. (Click to enlarge)

Right now FDA is looking at the big picture challenge of preparing the agency and industry, and actually getting the work done. Taylor called the implementation challenge “enormous”, thanks to the significant scale of the food system, and said the import piece of the regulation will take the most hands on deck. The ultimate goal of FSMA is real-time prevention versus reaction, and the regulation will require a lot of change within FDA. According to Taylor, the agency is revamping its internal management processes, along with its training and orientation programs, which also includes food safety culture training. Other activities include restructuring the inspection and compliance approach by realigning its field force to have fully specialized teams of inspectors.

One of the challenges that industry sees is the mindset shift in investigators from a resolutions approach to a systematic approach in assessing systems. When asked how FDA will get investigators to this level, Taylor admitted he was a lot more worried about the issue than he is now. The district folks in the front line are enthusiastic about the new approach and feel empowered by FDA’s new mission, he said. And while he didn’t want to be a Pollyanna about the extent of the effort, FDA knows that the agency workforce will not be 100% aligned on day one of implementation and is managing the process with this awareness.

Voluntary compliance is key, and while the weight of ultimate accountability stands on the shoulders of food and beverage companies, success cannot happen without collaboration with FDA. “We are convinced we’ll get 90% of the job done by working with those who are committed to doing the right thing,” said Taylor. “When that fails, there are other ways to deal with that issue.”

Five of the seven FSMA rules have been finalized. Michael Taylor and Rick Biros, publisher of Food Safety Tech and conference director of the Food Safety Consortium take a selfie to capture the "Kodak" moment.
Five of the seven FSMA rules have been finalized. Michael Taylor and Rick Biros, publisher of Food Safety Tech and conference director of the Food Safety Consortium, take a selfie to capture the “Kodak” moment.

All images by amyBcreative photography.

FDA’s Michael Taylor Joins in Honoring Food Safety Heroes

By Food Safety Tech Staff
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Last night at the Food Safety Consortium, STOP Foodborne Illness held a fundraiser to honor those who have dedicated their careers to raising awareness of foodborne illness and promoting a food safety culture. Here are some moments from the event.

FDA's Michael Taylor, deputy commissioner of foods, shares thoughts on the work and food safety advocacy of Nancy Donley and Frank Yiannas.
FDA’s Michael Taylor, deputy commissioner of foods, shares thoughts on the work and food safety advocacy of Nancy Donley and Frank Yiannas. Comments on progress made, and “There’s a lot to do to further instill food safety culture.”
Gina Kramer, Nancy Donley, STOP Foodborne Illness
Nancy Donley received the Legacy Tribute in recognition of her four-year-old son Alex, who died from an E. coli infection in 1993.
Frank Yiannas, vice president of food safety at Walmart received the 2015 Industry Advocate Hero for his role in going above and beyond in advocating food safety for the world's largest food retailer. Picture with Deirdre Schlunegger of STOP Foodborne Illness.
Frank Yiannas, vice president of food safety at Walmart received the 2015 Industry Advocate Hero for his role in going above and beyond in advocating food safety for the world’s largest food retailer. Picture with Deirdre Schlunegger of STOP Foodborne Illness. “This award will hold a special place in my heart,” said Yiannas.

All images by amyBcreative photography

Randy Fields, Repositrak
FST Soapbox

Dealing with FSMA’s Documentation Demands

By Randy Fields
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Randy Fields, Repositrak

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.

Jeff Moore, USP
FST Soapbox

Fighting the Reality of Food Fraud

By Jeff Moore, Ph.D.
Jeff Moore, USP

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.


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

FSMA Final Rules on Produce Safety, FSVP and Accredited Third-Party Certification Out

By Food Safety Tech Staff
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Unpublished documents available on Federal Register; FDA to weigh in at next week’s Food Safety Consortium.

FDA has released its final FSMA rules on produce safety, foreign supplier verification programs (FSVP) and accredited third-party certification. The documents were filed today and are scheduled to be published on the Federal Register the day after Thanksgiving, Friday, November 27.

An agency alert called the finalization of the rules “groundbreaking”, as FDA takes “major steps to prevent foodborne illness”.

The final FSMA rules (unpublished documents) are available for download:

Next week’s Food Safety Consortium will feature several sessions dedicated to the discussion of these rules, including:

  • “Ask the FDA” Town Hall with Michael Taylor, FDA Deputy Commissioner for Foods and Veterinary Medicine
  • Foreign Supplier Verification with Eric Putnam of Wixon, Inc. and Shawn Stevens of Food Industry Counsel, LLC
  • Compliance for Accredited Third Party Auditing with Trish Wester of PA Waster Consulting and Janet Raddatz of Sargento Foods, Inc.
Debby Newslow

Strong Prerequisite Programs Half the Battle in FSMA Compliance

By Maria Fontanazza
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Debby Newslow

Having a strong prerequisite program is a key part of maintaining compliance with FSMA and food safety management systems standards. In a recent discussion with Food Safety Tech, Debby Newslow, president of DL Newslow & Associates gave a preview of some of the expertise that she will be sharing during her session at next week’s Food Safety Consortium, “Food Safety/HACCP Prerequisite Programs” (session takes place Thursday, November 19).

Food Safety Tech: What are some of the challenges that companies face in establishing prerequisite programs for HACCP?

Debby Newslow: Understanding the significance of the prerequisite program—a lot of times, employees are [going through the motions] of things like wearing hairnets or not wearing jewelry—but [they need to] understand why it’s important. There’s a weakness in the education of employees. We need to redefine the word “training”, because training should mean education, too and understanding the importance of it. Companies take it for granted—they have defined procedures that they may or may not follow. And the other challenge is commitment and an understanding from management as to why it’s important.

On Wednesday, November 18, Debby Newslow will participate in the Ask the Experts session, “Food Safety Training Challenges”. LEARN MOREFST: What are best practices that companies can implement in this area?

Newslow: They need a program established, along with commitment to and support from a food safety team that has a responsibility to the team to evaluate the effectiveness. They also need support from top management. Every group and department needs to understand their requirements and why they’re important. They need to have the tools and the knowledge to understand what’s needed. Through the food safety team or internal audit team they can have the independence to monitor and look at its effectiveness. A lot of companies hold strong that the auditors need to find everything that’s wrong, and that’s an old school way of thinking.

Educate everyone and encourage them to take ownership for compliance, and use the internal programs and teams to evaluate the effectiveness.

On Thursday, November 19, Debby Newslow will present, Food Safety Management Systems—Understanding the Three Legged Stool” LEARN MOREFST: What do you hope attendees gain from your session on food safety & HACCP PRPs at the Food Safety Consortium?

Newslow: My session is going to be focused on prerequisite programs and how they fit with FSMA and the preventive controls (they really go side-by-side)

  1. I want folks not to be so nervous about FSMA. If they have a strong program now for food safety and HACCP, and have the prerequisite programs identified and managed, they’ll be 95% there for FSMA [compliance]. Companies really need to focus on their internal programs and have a food safety program that is compliant with FSMA, and expand and confirm the effectiveness of these internal programs. Take pest control, for example. Some companies will hire the outside company and will monitor and know the effectiveness on a regular basis. Other companies will hire an outside firm and let them do whatever they want, and not have a clue what’s going on. Then there are smaller companies that have someone come in, spray, and send them a bill, and they won’t even know what the [outside] company is using as an insecticide. So you have different levels, and that’s why we have to understand each program and what is required for effectiveness and compliance.
  2. The role of the prerequisite program and preventive controls is that if you look at recalls in today’s world, 90% of recalls are caused from ineffective or nonexistent prerequisite programs [Newslow estimate]. Very seldom do we see a recall because a CCP fails. We get so hung up on other things and forget why do we take off our jewelry, for example. The odds of something going wrong are thin but when you look at it from the big picture, it can happen and it does happen. I’ll have some significant recent examples in my session.
Rod Wheeler, The Global Food Defense Institute

Are Food Companies Prepared for Intentional Contamination?

By Maria Fontanazza
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Rod Wheeler, The Global Food Defense Institute

Unfortunately, quite often we are reminded of the vulnerabilities throughout the food supply chain. The latest E. coli outbreak linked to Chipotle restaurants in Oregon and Washington once again has consumers and the food safety industry on edge about traceability and a company’s ability to quickly identify the source of a serious outbreak. According to the CDC’s most recent update, laboratory testing is ongoing to find the DNA fingerprint of the bacteria. Concerning as this may be, no deaths have been reported thus far, but 42 people have been reported ill and 14 have been hospitalized in Washington and Oregon. In the most recent statement released on Chipotle’s website, the company said it is “aggressively” taking steps to address the problem, including by conducting deep cleaning and sanitization of its restaurants as well as environmental testing in its restaurants, and replacing all food items in the establishments that it closed “out of an abundance of caution”.

What if this were a situation of intentional contamination? Would Chipotle or any other company in this type of scenario really be prepared? These questions were posed by Rod Wheeler, CEO of The Global Food Defense Institute during a recent conversation with Food Safety Tech about food defense, and food tampering and intentional adulteration. Wheeler and Bruce Lesniak, president of Lesniak & Associates, shared their views on the threats that the food industry is facing and why companies need to have a strong plan in place to prepare for an attack on the food supply.

During next week’s Food Safety Consortium conference, Rod Wheeler will moderate the Ask the Experts session, “Engaging Food Tampering Discussion Surrounding Food Defense” on Wednesday, November 18.  LEARN MOREFood Safety Tech: What challenges do you see companies facing in the area of food tampering and adulteration?

Rod Wheeler: Our food supply is wide open. It accounts for 13% of the overall U.S. GDP. One thing we know about terrorists is that they want to affect our financial markets. What’s the best way to do that? You attack the 13% GDP – and what infrastructure is that? It’s our wireless systems, airline systems, transportation systems, medical supply, or our food and agricultural supply. Those are the top areas in which we need to focus, and we have to make sure the food & agriculture supply remains safe and secure in the United States.

On 9/11 the world changed, and the challenge for us becomes, within all of our 18 infrastructures, but how have we changed? Do we continue to do business the same way we always have, even prior to 9/11? Over the past few years, we’ve seen a significant increase in terroristic activity around the world—from France to Syria to Yemen to Pakistan. Here in the United States, we have to be mindful of what is happening.

Rod Wheeler, The Global Food Defense Institute
Rod Wheeler, CEO of The Global Food Defense Institute

We’ve always had food safety programs: HACCP, HARPC, GFSI, SQF, etc.—those are good for unintentional contamination. But what happens if someone wants to intentionally place a deadly contaminant into a product?

In this country, on a daily basis we see contaminations occurring.  We were recently notified of a massive outbreak of E. coli that has occurred throughout the Chipotle system: 47 Chipotle stores have been closed. What does that mean? Is that just a food safety issue? What if that E. coli could have been intentionally grown in a test tube and placed into the food supply? Going forward, we have a duty and an obligation to look at these things, not just at face value but think about whether they are intentional events.  

FST: Where are the biggest holes within food defense plans?

Wheeler: With more than 15 years of visiting food processing facilities, agricultural farms, dairy farms, and dairy processing facilities, the biggest concern that resonates with me is the fact that the culture of security is not there. The culture of security is simply security awareness—not planning. People in food plants are being taught to be mindful not vigilant. The largest of food companies have well thought out and active safety and defense plans, and their employees are educated, trained and empowered. We find that this falls off sharply with the mid-sized and small manufacturers and suppliers.  All food providers must have a comprehensive and strategic security plan that is active and measureable.

For example, let’s say a contractor is walking though a food plant. You have worked in that plant for five years but have never seen this person before. Would you question that person about their credentials? Are people thinking about the things they can personally do to reduce or mitigate the risk… are they empowered?

Darin Detwiler of STOP Foodborne Ilness, PCA sentencing
“When Someone Dies, It’s Not Business as Usual”: Darin Detwiler of STOP Foodborne Illness discusses the impact of the PCA sentencing on the food industry. Watch the video

So, the question is “what do you do when/if”: This is one of the topics we will be discussing at the [Food Safety Consortium] conference. It’s interesting that when we present this scenario to the management of a food company, many answer back with a blank stare. We ask, do you shut down your facility? Do you notify your customers? Do you notify the national media? This question goes to the root of the company’s security culture and the strength of its strategic planning. Until we develop the necessary plans, processes and protocols to respond proactively, we will continue to remain vulnerable.  

FST: Do you think many food companies assume something catastrophic won’t happen to them?

Wheeler: I always ask why it is that we don’t anticipate these things in advance. People are complacent. “It’s not going to have happen here,” they say. “What terrorist would come to our small town and do this? We’re just a small mom and pop [business].”

Recently, I received a call from a 17-employee company in Tennessee. This particular company processes honey for 100 large box retail stores. I received a call from the CEO who said, “My client wants us to have one of those vulnerability things.” He was referencing the vulnerability assessment. He said, “I don’t know why they’d want us to have one of those. We’re a small company down here in Tennessee, why does my client think some terrorist would come here?” The fact is, attackers will find the weakest link to attack: The small honey company is not the target; they are the vessel by which the attackers get to the primary target, and in this case, the big box retailer. The big box retailer/supplier is the target and the simplest, most effective way to get to them is through the hundreds of small, low to no protection suppliers.

These are the issues we need to enlighten and educate companies about; we need to get them thinking differently, because this way of thinking is completely different. If you ask someone who’s been in this industry for years, they’ll say, we never had to worry about locking our doors, or use biometrics to gain access to certain areas. We never had to think about these things in the Food & Ag supply before.

During our front line training course, we place a significant amount of focus on the food plant blending areas and why it is the number one threat area for intentional/unintentional contamination of our food supply in the United States. The blending area is exposed to a number of vulnerabilities and once attacked, the tainted ingredients are spread among numerous products that once distributed, are not necessarily quickly traced once they are blended into the final product.

Bruce Lesniak: The consequences of such an emergency are multifaceted; they affect the consumer and their product confidence, the manufacturer through recall and the retailer through recall, brand damage and loss of consumer loyalty. Often, this ripple effect begins with the small supplier and works its way upstream to affect the entire process.

We are seeing this scenario unfold in real time with Chipotle—this is huge in the food industry. FDA has not been able to determine exactly where that genetic fingerprint has originated resulting in location closures, shaken consumer confidence and brand damage. –Rod Wheeler

FST: What will it take the industry to wake up to what could become a serious reality?

Wheeler: Unfortunately it’s probably going to take a major incident for people to wake up and smell the coffee. With that said, we firmly believe that it is critical to awaken the sleeping giants before something happens. We must increase the awareness and provide education to heighten the reality of what can potentially happen and promote proactive engagement of risk mitigation.

FST: In the context of FSMA, are companies prepared for the compliance stage?

Wheeler: Over the years, I’ve seen a number of companies begin to ramp up security at their facilities. But a number of them are doing it because they realize they need to comply with the food defense elements of FSMA; the larger companies are driving compliance and are requiring that their suppliers comply. But I think convincing companies about “Why” this is important, is the challenge. Often times companies will say, “we’re doing this training”, or “we’re doing this vulnerability assessment because it’s a requirement of FSMA.”

We feel that if being compliant is your “Why “reason, then you are spending time and money for the entirely wrong reason. You don’t do vulnerability assessment or training in food defense because you want to comply with the law. You do it because you want to protect your company and the consumer from the reality of what can happen and proactively work to avoid a threat.

Lesniak: We see the adoption trend take hold as it has traditionally, in three phases. First are the early adopters—they understand the importance of compliance for the right reasons and the need for food defense, Second are those who feel the urgency to comply due to a compelling issues (an incident or have been instructed to do so by larger suppliers in order to retain contracts), and third are those who will come kicking and screaming.

Wheeler: A lot of the requirements of FSMA were generated as a result of the PCA event in 2009. The prosecution and subsequent conviction of the Parnell brothers isn’t the last prosecution we’re going to see for someone violating a food safety protocol. This is the first, and it’s a wake up call.

Ryan Gooley, Mock Recalls

Practice, Practice, Practice. Why Mock Recalls Are So Important

By Maria Fontanazza
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Ryan Gooley, Mock Recalls

Being recall ready goes beyond checking off the boxes for meeting traceability requirements, qualification standards, or meeting auditing requirements for certifications. “It’s really a discussion that needs to happen from a business continuity standpoint within an organization so that should there be an issue, the team has actually talked through different strategies and ways of technically executing a recall within the organization,” says Ryan Gooley, recall consultant at Stericycle ExpertSolutions. During an interactive workshop at next week’s Food Safety Consortium conference, Gooley will lead attendees through recall scenarios and help them create a recall plan to address global needs, communications strategies, resource allocation, and business continuity requirements. Gooley recently sat down with Food Safety Tech to discuss the importance of mock recalls within the food industry.

Food Safety Tech: What are the most common mistakes food companies make in preparing (or not preparing) for a recall?

Ryan Gooley: One of the mistakes companies make is not having the discussion internally about a recall and whether they are ready and able to respond to and support a recall. Although it’s becoming less of an issue, people still don’t want to talk about recalls—they’re afraid if they talk about it, it will happen to them.

They also take their industry partners, whether supply chain partners or existing vendors, for granted.

Ryan Gooley is leading a session, The Multiplier Effect: How One Ingredient Can Lead to Multiple Recalls, at the 2016  Food Safety Consortium conference  on Thursday, December 8 | Learn More In addition, companies miss the amount of effort and resources it takes to properly support a recall once a communication goes out. This specifically relates to class I or class II recalls that go down to the consumer level and involve press releases and media exposure.

In any industry, your resources are geared toward producing product and getting it into the market; it’s not the reverse of managing take-backs and returns, and communicating to customers. A lot of it comes down to resource allocation.

FST: What are the most important elements of a recall plan in the food industry?

Gooley: Traceability is huge. Most companies have a pretty good understanding of traceability as it relates to where they receive ingredients, where the ingredients go within their processes, and ultimately where they are distributed. Traceability is important, because you can’t initiate a recall if you cannot identify where the suspect product went.

The other part of the recall plan is testing the plan. Going through your recall plan and testing it pulls together the different departments that are responsible for supporting the recall exercise and effort within the company. Having conversations about who is responsible for what, the information [that should be] pulled, and who needs that information is really important for building the team. [It ensures that] should a company need to initiate a recall, the team members who are engaged and responsible have actually talked through the process and practiced. With more practice comes more efficiency and less chance for error or oversights.

Another important element of a recall plan is understanding your communication plan and communication crisis management plan. A lot of people talk about recalls as just identifying the product and notifying downstream what to stop selling, etc., but a lot of what goes into the recall plan is business strategy—how are you going to manage not only retailer and customer calls, but consumer calls and media calls? Who is responsible for communicating what, when and where? Do you notify just your impacted customer or do you notify your non-impacted customers? What type of communication and messaging do you have? When companies have not done a mock recall exercise, oftentimes they have not had these conversations, and they really struggle on the communications piece, especially because it needs to be drafted, approved, and communicated in a very short period of time.