Tag Archives: compliance

FST Soapbox

Technology Can Help Food Manufacturers Navigate FSMA in 2016

By Jack Payne
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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.

FSMA
Not surprisingly, most food manufacturers say they are being impacted by FSMA

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.

Risk, food safety

Seven Threats to the Food Supply Chain

By Food Safety Tech Staff
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Risk, food safety

Food businesses face a range of risks, from lack of consumer confidence to supply chain security. As FSMA regulations and issues such as climate change rise to the top of the list of priorities of global governments and regulators, food companies need to secure the reins on their businesses to ensure they can face these seven emerging risks in 2016 and beyond.

SevenEmergingRisks_FoodSupply
Infographic courtesy of EtQ, Inc.

 

Food Safety Consortium

Moving Produce Rule Forward, United States and Mexico Partnership Critical

By Food Safety Tech Staff
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Food Safety Consortium

During an FDA Town Hall at the 2015 Food Safety Consortium, FDA Deputy Commissioner for Foods and Veterinary Watch video of Taylor’s speech: Part I and Part IIMedicine Michael Taylor was asked about implementation of the produce rule from the perspective of Mexico. Taylor touched on the partnership, announced about a year ago, between the United States and Mexico in recognition of the fact that working together will be the only way to move forward in verifying compliance with the new rule. “Our work with Mexico on produce safety is one of the most important things we’re doing right now in implementing FSMA,” said Taylor.

Compliance fail

Senior Execs in for a Rude Awakening Regarding Supply Chain Compliance

By Maria Fontanazza
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Compliance fail

In previous years, supplier compliance was oftentimes built on trust. With FSMA tightening the reigns on compliance via auditing and documentation requirements and unannounced inspections, a higher level of accountability is being placed on companies, from the employees on the manufacturing floor all the way up to the C-suite. However, when senior executives start digging into the level of compliance maintained by their suppliers, they might not like what they find. In fact, they might be downright shocked, according to Randy Fields, chairman and CEO of Park City Group. “Instead of maintaining control over these issues of compliance, by delegating it and not properly supervising it, they’ve [senior management] lost visibility,” Fields says. “They have to be more involved than in the past, because they’re on the hook for it. But, they’re going to discover that their supply chain is nowhere near as compliant as they imagined.” In a Q&A with Food Safety Tech, Fields discusses how FSMA is changing the game for executives in the food business.

Food Safety Tech: In the context of supply chain accountability, increased interaction is now essential between food safety managers and executives. What level of awareness is required in the C-suite?

Randy Fields
Randy Fields, chairman and CEO of Park City Group, says the C-suite is not ready for what it is going to discover in terms of lack of compliance in the supply chain.

Randy Fields: Given the change in the law (FSMA), the regulatory world, and increasingly, the world of tort, the unfortunate reality is that the C-suite in nowhere near as aware of the issues of accountability in the supply chain as they need to be. It breaks down into two pieces: First, they have entrusted supply chain compliance to other people in the business; it’s been dropped down too far within the organization without the proper oversight.

Second, they don’t have a good way of measuring compliance—it’s been based on trust. Compliance has become more complex and as a function of the complexity, [senior management] doesn’t have a good set of tools by which they can stay on top of compliance and measure it.

With the change in the law, accountability has legally moved up to the C-suite, because FSMA, for all intents and purposes, brings Sarbanes–Oxley to the FDA. Between FSMA and tort, the way that it’s been is about to change very dramatically, but the surprises are all downside surprises. The consequence of trust without verification is now likely to lead both to litigation and possible criminal conviction. This is a different world.

The basic level of compliance in the global supply chain is far worse than anyone ever imagined. It will be not unlike turning over stones in your backyard in terms of what’s going to crawl out.

“Personal liability is probably the ultimate determinate of whether or not the C-suite starts to pay attention.” –FieldsFST: Is there a larger responsibility on the part of food safety managers to translate the compliance message to the C-suite?

Fields: I think it’s now both the appropriate responsibility and potentially the legal responsibility of food safety managers to insist that their C-suite become aware and provide them both the oversight and the tools by which compliance can be continually and professionally supervised and managed. I think failure to do that represents negligence.

Tort claims are getting more frequent and larger for foodborne illness problems. And now with both civil and criminal penalties potentially being applied by the FDA, it’s a game changer. It cannot be business as usual. This changes the world for food safety managers, and it changes the world for their bosses. We live in a world now where, whether we like it or not, the concept of accountability is about to be more legally enforceable.

The Peanut Corporation of America sentences are exemplary. But strict liability means that there can be a criminal prosecution without intent or even conceptually gross negligence. It is only a matter of fact that you supervised the function that was involved.

There’s a set of issues here that food safety managers should be bringing to the attention of senior executives. It’s beholden on them to say to these guys, ‘you have to pay more attention to this because you’re legally, civilly and criminally on the hook.’

FST: Do these factors have an impact on the type of professionals that are needed within food businesses?

Fields: Yes. I suspect that what will happen over the long term is that food safety will not be as much [about] science as it is compliance. In many companies, the food safety people tend to be the scientists who may not be as interested in the whole compliance problem. Increasingly, it’s the whole problem of compliance, not just the problem of food science.

We typically see within a company that someone manages the insurance part of the supply chain; someone else manages the food safety part of the supply chain, and someone else manages some other part of it: All of that fits under the rubric of compliance. We’re seeing more and more companies beginning to address this holistically.

Jill Bender, SafetyChain

GFSI in the Age of FSMA Series Helps Companies Prepare for FSMA Compliance

By Jill Bender
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Jill Bender, SafetyChain

The “GFSI in the Age of FSMA” three-part series wrapped up in early December, providing the food safety community insight on how leading GFSI schemes align with, and help prepare for, compliance with FSMA.  The series was presented by SafetyChain with media partner FoodSafetyTech.

Each GFSI scheme leader from SQF, BRC and FSSC 22000 discussed how their schemes align with FSMA in several key areas, including Supply Chain Controls, migrating Food Safety Plans from HACCP to HARPC, and audit readiness. While each scheme leader provided insights and details on how their scheme aligns with FSMA, common key themes across all three sessions included: 

  • FSMA’s focus on prevention vs. reaction is similar and aligns with GFSI’s objectives; Scheme certifications and ongoing compliance is centered around continuously assessing risks and putting preventive measures in place to mitigate those risks
  • GFSI’s global approach surrounding a company’s food safety program—to ensure better supply chain controls internally, upstream and downstream prepares companies to manage FSMA’s increased focus on both domestic and foreign supplier compliance
  • GFSI stringent documentation and recordkeeping requirements—along with unannounced audit protocols—are a strong foundation to help food and beverage companies prepare for FSMA’s “if it isn’t documented you didn’t do it” mantra

The GFSI scheme leaders also spoke about the importance and opportunity companies have to leverage technology tools to help more effectively manage the complexities and requirements of GFSI and FSMA compliance.  Series participants were able to see an example of how these automation tools work and the impact they can have on managing a robust food safety program via a post session demo of SafetyChain Software.

Archived recordings of all three sessions—SQF in the Age of FSMA, featuring Robert Garfield, Senior VP, SQF; BRC in the Age of FSMA, featuring John Kukoly, Director, BRC Americas; and FSSC 22000 in the Age of FSMA, featuring Jacqueline Southee, U.S. Liaison, FSSC 22000—are available and can be accessed here.

Imports

FSMA’s FSVP: Clearing the Confusion of Importing Rules

By Charles Breen
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Imports

On November 27, 2015, the Foreign Supplier Verification Programs for Food Importers (FSVP Rule) published in the Federal Register. The most significant new element is that importers are now responsible for assuring that the food they import complies with FDA requirements. Instead of action against violative food, FDA is now equipped to take regulatory action against importers that fail to provide necessary assurance of food safety.

“Importer” is defined as: “the U.S. owner or consignee of an article of food that is being offered for import into the United States. If there is no U.S. owner or consignee of an article of food at the time of U.S. entry, the importer is the U.S. agent or representative of the foreign owner or consignee at the time of entry, as confirmed in a signed statement of consent to serve as the importer under the FSVP regulations.” This differs from the importer of record as defined by Customs and Border Protection (CBP) as the person primarily responsible for paying any duties or an authorized agent acting on his behalf.

Under FSVP, an importer’s basic responsibilities are to:

  • Determine hazards reasonably likely to cause illness or injury
  • Evaluate the risk, using hazard analysis
  • Evaluate the foreign supplier’s performance
  • Perform supplier verification activities

Determining hazards and evaluating risk parallel the preventive control rules for human food (PCHF) and animal food (PCAF). Evaluation of a foreign supplier’s food safety performance and conducting verification activities are substantially aligned with supply-chain verification in 21 CFR 117 Subpart F (PCHF) and 21 CFR 507 Subpart E (PCAF). The importer is responsible for assuring compliance with FDA standards and requirements.

Deciding what parts of FSVP are applicable to each importer’s operation requires a comparison between what the importer does, and the exemptions, exceptions and modified requirements offered in the rule. These depend on what is imported, the food safety system in country of origin, the size of the importer, and the size of the foreign supplier. FDA delivered on its promise of flexibility, but deciding what applies requires some analysis.

If a food importer meets the definition of importer and does not fall into an exempted category or qualify for exceptions or modifications, then some or all of the FSVP rule applies to them. FDA estimates that about 55,000 importers will be covered by FSVP or some portion of it.

Who Is an Importer?

The U.S. owner or consignee of an article of food that is being offered for import into the United States is the importer. If there is no U.S. owner or consignee of an article of food at the time of U.S. entry, the U.S. agent or representative of the foreign owner or consignee at the time of entry is the importer.

All importers must provide an identification number for each entry line of food that the importer brings into the country. FDA will be issuing more guidance on what it considers “an acceptable identification number.”  The agency is not mandating that each facility use a DUNS number, but is has ruled out other suggestions for the unique identification number that is required.

Exemptions to FSVP

FSVP does not apply to the following foods:

  • Fish and fishery products (in compliance seafood HACCP in 21 CRF 123)
  • Juice (in compliance with juice HACCP in 21 CFR 120)
  • Food for research or evaluation
  • Alcoholic beverages
  • Meat, poultry, and egg products regulated by USDA
  • Food imported for personal consumption,
  • Food that is transshipped through the United States
  • Food that is imported for processing and later export
  • U.S. food that is exported and returned without further manufacturing or processing in a foreign country (U.S. foods returned)

Partial exemption for import of low-acid canned foods (LACF). LACF are exempt from FSVP with respect to microbiological hazards for that food. To be exempt, the importer must verify and document that the food was produced in accordance with LACF requirements (21 CFR part 113). Other hazards not controlled by the LACF rule, if any, must be documented as controlled under FSVP.

Modified Requirements

Modified requirements for a receiving facility in compliance with the PCHF or PCAF rules that imports food:

  • If the process used controls the hazards of the imported food, the facility is considered in compliance with most of the FSVP rule.
  • If the food does not have any identified hazards requiring control, then the facility is considered in compliance with most of the FSVP rule.
  • If the facility has implemented a supply-chain program for the food in compliance with either PCHF or PCAF requirements, the facility is considered to be in compliance with most of the FSVP rule.

Receiving facilities must also accurately identify themselves to FDA for each entry line of food being imported.

Modified requirements for imported dietary supplements manufactured in compliance with CGMP requirements in 21 CFR part 111:

The importer must accurately identify itself to FDA for each entry line of dietary supplement or dietary ingredient being imported.

Modified requirements for very small importers:

Defined as less than $1 million in sales of human food a year, or less than $2.5 million in sales of animal food per year, very small importers would not have to conduct hazard analyses and would be able to verify their foreign suppliers by obtaining written assurances of compliance from those facilities.

Modified requirements for imports from small suppliers (i.e., qualified facilities under PCHF or PCAF, and some small farms not covered farms under the produce safety standards, and some small egg producers):

The importer must obtain written assurance before importing the food, and at least every two years after, that the foreign supplier is producing the food in compliance with applicable FDA food safety regulations or the laws and regulations of a country whose food safety system FDA has officially recognized as comparable or determined to be equivalent to that of the United States.

Modified requirements for food imported from a country with an officially recognized or equivalent food safety system:

Importers must determine that the supplier is in compliance with FDA requirements, or that the supplier is in compliance with food safety regulations or relevant laws in the country that FDA recognizes as equivalent.

At present, only New Zealand is officially recognized as comparable to the United States. FDA is in the process of auditing and evaluating audit results for mutual recognition with additional countries. The next countries to be recognized will most likely be Australia and Canada.

One final note: FSVP requires coverage of food contact surfaces, such as packaging. Manufacturers of food contact surfaces are not required to register with FDA. PCHF and PCAF rules are limited to those facilities required to register. The language requiring FSVP makes no exception for food contact surfaces.

Mobile technology and food safety

The Digital Revolution in Food Safety

By Manik Suri
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Mobile technology and food safety

News concerning the safety of food seems to be everywhere these days. On a daily basis there’s a story about a salmonella outbreak or a company initiating a product recall due to possible contamination. Why is this the case?

If you visit most food businesses, whether it’s a restaurant, grocery store, manufacturer or foodservice operator, chances are you’ll see the same thing: Employees using pen and paper checklists, forms and log books to manage their food safety operations.

The recent E. coli outbreak traced to Chipotle Mexican Grill infected more than 50 people and led the company to shut down several restaurants. The outbreak was also a PR disaster for the company and damaged its reputation as a reliable provider of safe meals. Chipotle lost out on potential revenue and probably spent a good amount of money on hiring outside food safety consultants to examine its safety standards.

Since starting the business, Chipotle has remained focused on a core mission: Make great-tasting food, and more recently, food that is not modified with GMOs. While its goal has not changed, running a food company is vastly different today than in the past.

Modern Food Safety Isn’t So Modern

For one thing, there is a lot more paper to manage in today’s world. Between time and temperature controls, HACCP and HARPC requirements, and a whole host of industry certifications and brand standards, food businesses implement several safety processes. Even with advancements in technology, food safety operations are often run manually and therefore are error-prone.

In the early 1990s, food companies could handle the volume of paperwork themselves. Today, they’re swamped. Visit a food business, and you’ll see the same thing everywhere: Stacks of documents that need to be typed up and sent to food agencies. As one quality assurance manager recently stated, “We can barely keep track of them all.”

Surrounded by stacks of paper in their office, quality assurance (QA) managers explain that much of the pileup is due to more rules and regulations related to food safety. Food companies must comply with a growing number of local, state and federal laws that regulate food safety. The focus of recent laws such as FSMA is toward prevention of foodborne illness, placing even more emphasis on internal audits and recordkeeping. In addition to these laws, food companies must compete with the wealth of information available to customers about how their food safety operations work. Especially in the realm of social media, as Taco Bell has learned, one photo of an employee playing with food can lead to a PR nightmare.

A Day in the Life of a QA Manager

Complying with food safety laws often falls on a company’s QA manager who supervises food safety. She walks through the facility several times a day with clipboard in hand, reviewing a list of safety and quality measures.

The QA manager will then manually key this data into a spreadsheet, create reports, and file the results with industry partners and government regulators. These seemingly routine and time-consuming compliance tasks matter. Failing to comply with the appropriate laws can lead to costly penalties, permitting delays, loss of business from industry partners (such as retailers with strict requirements), and even legal action.

The legal requirements are often complex, overlapping, and they change every couple of years. The laws are designed, of course, to ensure that food preparation and delivery is safe, thereby protecting consumers. But an expanding body of regulations and fear of litigation have increased the time, cost and stress that play into compliance.

Mobile technology and food safety
Mobile tools can help companies improve food safety processes.

Improve Food Safety with Technology

So how can companies improve their food safety operations? By using food safety technology, particularly mobile software tools, to improve their processes. Since food safety operations are still manual, they tend to be hard to standardize and difficult to track—especially at larger companies where employees are working in multiple shifts across dozens of locations. Mobile food safety software offers several major benefits:

  • No More Pen and Paper. Replacing paper-and-pencil clipboards with digital tools saves time and money. Digital audits and task-lists can be logged and tracked, ensuring that staff are performing tasks in real-time. Digital entries are more accountable; managers can confirm when and where tasks where conducted and completed (including requiring photos to be taken). And digital clipboards can be loaded with reference materials like images and training videos, which helps staff learn best practices and prepare for real inspections by government agencies.
  • Quality and Safety Checklists. Instead of letting employees complete tasks ad hoc and make notes on clipboards and log books, companies can use quality and safety checklists to ensure that key tasks are standardized across the organization. For example, data can be collected to show that a company is always forgetting to label produce with an expiration date. Digital food safety and quality checklists that are loaded on smartphones or tablets makes it easier to ensure that all employees are following brand standards and best practices.
  • Automated Reports. Instead of sifting through binders filled with audit logs, food safety software captures and stores data in a structured format, making it easy to search and analyze. Why waste hours at the end of every week or month sifting through binders full of paper, when software lets you generate insights with the click of a button?
  • Real-Time, Centralized Management. Food companies often have multiple locations in which employees are conducting food safety operations in their own way. For companies that have multiple locations, mobile software being used by employees at each location can help corporate managers track performance by location, provide critical alerts, and give employees real-time feedback to help standardize food safety operations.

Here’s an example of a QA manager running a food safety audit using mobile software. During a random spot check, the manager shows up on the line with a smartphone in hand. As she walks around, she pulls up a food safety application and answers a series of pre-set multiple choices questions that cover key criteria, dictates comments into the device using the built-in voice recognition, and takes high-resolution color photos of several problematic issues. If a QA manager is unsure about food safety requirements, she can use her mobile device to quickly pull up a reference document (or even the official code citation) from state, FDA, USDA or other agencies.

After running a digital audit with food safety software, the QA manager can immediately print or e-mail a report that shows all of the items out of compliance, creating actionable intelligence for her team. The QA manager can then share this with line workers during their weekly team meeting, which help to train staff on best practices in food safety.

The data the QA manager collected through her mobile device is immediately stored in the cloud. From there it can be easily accessed by a colleague (i.e., her manager at corporate headquarters) at any time. Over time, the data from each of these spot checks is stored in a central database that a manager can analyze, looking for trends in performance, issues that keep arising, or locations that may need extra training and attention. Mobile software makes it easier to generate insights that can drive major improvements in an organization’s safety and performance.

By using software to help manage food safety audits, logs and line checks, businesses can save time and money on compliance, train staff on best practices, and most importantly, keep customers safe and satisfied.

Today, food safety technology, especially mobile software, should be a critical part of any modern food company’s operations. Mobile audit and task-management software allows QA managers to streamline and standardize quality and safety operations across large teams and multiple locations, helping save valuable time and money. Whether you’re a mobile food vendor or a large-scale food processor, modern software tools can help food businesses of all sizes effectively manage time-consuming tasks around food safety and compliance, from digitizing audit logs for analysis to created automated filings for supply chain partners.

Michael Taylor reflects on FSMA journey

Metrics for FSMA Compliance a Work in Progress

By Food Safety Tech Staff
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Michael Taylor reflects on FSMA journey

Ideally, FDA wants to have the ability to use metrics for monitoring and measuring reductions in foodborne illnesses. However, this is extremely difficult right now, according to Michael Taylor, FDA deputy commissioner for foods and veterinary medicine. At the 2015 Food Safety Consortium, Taylor responds to an audience question of whether metrics for FSMA compliance have been established.

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.

FDA

FDA Awards $600,000 for FSMA Training Center

By Food Safety Tech Staff
1 Comment
FDA

Today FDA announced its strategy for training the food industry as part of the successful implementation of FSMA. This included awarding a $600,000 grant to the International Food Protection Training Institute (IFPTI) to establish a National Coordination Center. This center will serve an important function in the training process for the food industry.

“One size won’t fit all when it comes to training,” according to an FDA release. “The most important goal that the FDA expects of any training program is the outcome—that it advances knowledge among the food industry to meet FSMA requirements.” The agency indicated that there will be different options and delivery formats for the training, but wants all hands on deck—domestic and international stakeholders from government, industry and academia—to work with FDA on developing and delivering the training to food suppliers.

The major components of the FSMA Training Strategy include:

  • Crafting the FSMA alliance curricula
    • The alliances include the Produce Safety Alliance, the Food Safety Preventive Controls Alliance and the Sprout Safety Alliance
  • Alternate training options
  • Cooperative agreements, including a five-year agreement with the National Association of State Departments of Agriculture
  • Establishing the National Coordination and Regional Centers to support training delivery
  • Delivering the training
    • The three above alliances are developing a Train-the-Trainer program to provide training via an established process. A range of partners will be involved, including the Association of Food and Drug Officials, the Association of Public Health Laboratories, and the Association of American Feed Control Officials
  • A FSMA collaborative training forum co-chaired by FDA and USDA