Tag Archives: accountability

Data protection, security

The Digital Transformation of Global Food Security

By Katie Evans
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Data protection, security

Modern food supply chains are inherently complex, with products typically passing through multiple suppliers and distributors, as well as countries and continents, before they end up on the supermarket shelf. While global supply chains offer consumers greater choice and convenience, they also make protecting the security of food products more challenging. With additional stakeholders between farm and fork, products are exposed to an elevated risk of biological or chemical contamination, as well as food counterfeiting and adulteration challenges—potentially putting consumer health and brand reputation in jeopardy.

Given the importance of maintaining the safety, quality and provenance of food products, global regulatory bodies are placing the integrity of supply chains under increased scrutiny. In the United States, for example, the adoption of FSMA moved the focus from responding to foodborne illnesses to preventing them by prioritizing comprehensive food testing measures, enforcing inspections and checks, and enabling authorities to react appropriately to safety issues through fines, recalls or permit suspensions.1 Similarly, China’s revised Food Safety Law (known as FSL 2015) is widely considered to be the strictest in the country’s history, and seeks to drive up quality standards by empowering regulators, and enhancing traceability and accountability through robust record-keeping. 2 The European Union continues to closely regulate and monitor food safety through its General Food Law, which is independently overseen by the European Food Safety Authority from a scientific perspective.

Achieving the Highest Standards of Food Security, Integrity and Traceability

For producers, manufacturers and distributors, the heightened regulatory focus on the security and integrity of the food supply chain has placed additional emphasis on accurate record-keeping, transparent accountability and end-to-end traceability. To meet the needs of the modern regulatory landscape, food chain stakeholders require robust systems and tools to manage their quality control (QC), environmental monitoring and chain of custody data. Despite this, many businesses still handle this information using paper-based approaches or localized spreadsheets, which can compromise operational efficiency and regulatory compliance.

The fundamental flaw of these traditional data management approaches is their reliance on manual data entry and transcription steps, leaving information vulnerable to human error. To ensure the accuracy of data, some companies implement resource-intensive verification or review checks. However, these steps inevitably extend workflows and delay decision-making, ultimately holding up the release of products at a high cost to businesses. Moreover, as paper and spreadsheet-based data management systems must be updated by hand, they often serve merely as a record of past events and are unable to provide insight into ongoing activities. The time lag associated with recording and accessing supply chain information means that vital insight is typically unavailable until the end of a process, and data cannot be used to optimize operations in real-time.

Furthermore, using traditional data management approaches, gathering information in the event of an audit or food safety incident can be extremely challenging. Trawling through paperwork or requesting information contained in spreadsheets saved on local computers is time-consuming and resource-intensive. When it comes to establishing accountability for actions, these systems are often unable to provide a complete audit trail of events.

Digital Solutions Transform Food Security and Compliance

Given the limitations of traditional workflows, food supply chain stakeholders are increasingly seeking more robust data management solutions that will allow them to drive efficiency, while meeting the latest regulatory expectations. For many businesses, laboratory information management systems (LIMS) are proving to be a highly effective solution for collecting, storing and sharing their QC, environmental monitoring and chain of custody data.

One of the most significant advantages of managing data using LIMS is the way in which they bring together people, instruments, workflows and data in a single integrated system. When it comes to managing the receipt of raw materials, for example, LIMS can improve overall workflow visibility, and help to make processes faster and more efficient. By using barcodes, radiofrequency identification (RFID) tags or near-field communication, samples can be tracked by the system throughout various laboratory and storage locations. With LIMS tracking samples at every stage, ingredients and other materials can be automatically released into production as soon as the QC results have been authorized, streamlining processes and eliminating costly delays.

By storing the standard operating procedures (SOPs) used for raw material testing or QC centrally in a LIMS, worklists, protocols and instrument methods can be automatically downloaded directly to equipment. In this way, LIMS are able to eliminate time-consuming data entry steps, reducing the potential for human error and improving data integrity. When integrated with laboratory execution systems (LES), these solutions can even guide operators step-by-step through procedures, ensuring SOPs are executed consistently, and in a regulatory compliant manner. Not only can these integrated solutions improve the reliability and consistency of data by making sure tests are performed in a standardized way across multiple sites and testing teams, they can also boost operational efficiency by simplifying set-up procedures and accelerating the delivery of results. What’s more, because LIMS can provide a detailed audit trail of all user interactions within the system, this centralized approach to data management is a robust way of ensuring full traceability and accountability.

This high level of operational efficiency and usability also extends to the way in which data is processed, analyzed and reported. LIMS platforms can support multi-level parameter review and can rapidly perform calculations and check results against specifications for relevant customers. In this way, LIMS can ensure pathogens, pesticides and veterinary drug residues are within specifications for specific markets. With all data stored centrally, certificates of analysis can be automatically delivered to enterprise resource planning (ERP) software or process information management systems (PIMS) to facilitate rapid decision-making and batch release. Furthermore, the sophisticated data analysis tools built into the most advanced LIMS software enable users to monitor the way in which instruments are used and how they are performing, helping businesses to manage their assets more efficiently. Using predictive algorithms to warn users when principal QC instruments are showing early signs of deterioration, the latest LIMS can help companies take preventative action before small issues turn into much bigger problems. As a result, these powerful tools can help to reduce unplanned maintenance, keep supply chains moving, and better maintain the quality and integrity of goods.

While LIMS are very effective at building more resilient supply chains and preventing food security issues, they also make responding to potential threats much faster, easier and more efficient. With real-time access to QC, environmental monitoring and chain of custody data, food contamination or adulteration issues can be detected early, triggering the prompt isolation of affected batches before they are released. And in the event of a recall or audit, batch traceability in modern LIMS enables the rapid retrieval of relevant results and metadata associated with suspect products through all stages of production. This allows the determination of affected batches and swift action to be taken, which can be instrumental in protecting consumer safety as well as brand value.

Using LIMS to Protect Security and Integrity of the Food Supply Chain

Increasingly, LIMS are helping businesses transform food security by bringing people, instruments and workflows into a single integrated system. By simplifying and automating processes, providing end-to-end visibility across the food supply chain, and protecting the integrity of data at every stage, these robust digital solutions are not only helping food supply chain stakeholders to ensure full compliance with the latest regulations; they are enabling businesses to operate more efficiently, too.

References

  1. FDA. (2011). FDA Food Safety Modernization Act. Accessed October 3, 2019. Retrieved from https://www.fda.gov/food/food-safety-modernization-act-fsma/full-text-food-safety-modernization-act-fsma.
  2. Balzano, J. (2015). “Revised Food Safety Law In China Signals Many Changes And Some Surprises”. Forbes. Accessed October 3, 2019. Retrieved from https://www.forbes.com/sites/johnbalzano/2015/05/03/revised-food-safety-law-in-china-signals-many-changes-and-some-surprises/#624b72db6e59.
Jorge Hernandez, All Baroudi, 2019 Food Safety Consortium Conference & Expo

Food Safety Professionals: Earn Respect and Be True to Yourself

By Maria Fontanazza
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Jorge Hernandez, All Baroudi, 2019 Food Safety Consortium Conference & Expo

Food safety professionals are underappreciated. This statement was met with a round of applause last week at the seventh annual Food Safety Consortium. It was made by Bob Pudlock, president of Gulf Stream Search, who has heard the remark from folks working in this demanding field many times, as his firm works to place them in food safety and quality positions within the industry. Pudlock shared his advice on how you, the food safety professional, can better market yourself and earn the respect of peers and higher-ups, as well as how those who are doing the hiring should approach the process.

Read Bob Pudlock’s insights on recruiting in the food safety and quality field in his column series, Architect the Perfect Food Safety TeamCompany cultures change, the popularity of products (and their safety) ebbs and flows, company leadership fluctuates and a company may even move its corporate headquarters. Amidst all of these changes, the only things that a professional can control are his or her reputation, professional acumen, and enhancing one’s education, said Pudlock. “Focus your energy on improving parts of you. Invest in your brand,” he said. “You never know how you’re being perceived and who’s out there in the crowd.” He added that it’s important to take a moment to do some deep digging and ask questions that can help draw out greater meaning:

  • What do you want to be when you “grow up”?
    • Where are you in your career today?
    • What do you aspire to?
    • What are the obstacles? What’s keeping you from getting there?
Bob Pudlock, 2019 Food Safety Consortium Conference & Expo
Bob Pudlock, president of Gulf Stream Search

“Get yourself in a position where you’re personally responsible for getting yourself in the right lane,” said Pudlock, emphasizing the importance of accountability. He also advises that professionals take a moment each day to work through organizational issues via journaling. Writing serves as a cathartic exercise and can help as one is going through the problem-solving process. “Work through your overwhelm with journaling,” he said.

On Earning Respect

On the final day of the Food Safety Consortium, Pudlock led a panel of industry stakeholders who shared their insights on how to remain motivated and earn the respect of peers and superiors in the industry.

Pudlock: As a food safety professional, what has contributed to your ability earn respect from the peers who you’ve worked with over the years?

Jorge Hernandez, Al Baroudi, 2019 Food Safety Consortium Conference & Expo
(left to right) Jorge Hernandez, vice president, quality assurance at The Wendy’s Company and Al Baroudi, Ph.D., vice president of quality assurance and food safety at The Cheesecake Factory at the 2019 Food Safety Consortium Conference & Expo

Jorge Hernandez, vice president, quality assurance at The Wendy’s Company

“What I’ve learned throughout my career is the fact that you have to understand why you are doing this. You have to reach inside and figure out for yourself, and then build your brand around that. It has to be honest; it has to be true to you. Why are you doing this? Is it to get a paycheck? Is it to get away from the kids? There are multiple reasons. There will be times in this field that you have to make the tough decisions. As you build your career, try to figure out why you really want to do this.”

April Bishop, senior director of food safety at TreeHouse Foods/Bay Valley Foods

“The ‘why’ is for those around me: We [speak] a lot of scientific jargon, and we know what we’re talking about. But the folks on the other side—in sanitation [for example], doing the most miserable job at the worst hours and in the worst condition, [for them] I need to translate all the way to the top on why we need so much time to clean the plants. Simplify the scientific jargon down to the facts that people can understand. Sell them on the ‘why’ of what they’re doing.

April Bishop, Marcus Burgess, 2019 Food Safety Consortium Conference & Expo
(left to right) April Bishop, senior director of food safety at TreeHouse Foods/Bay Valley Foods and Marcus Burgess, senior food safety and quality systems specialist at The Cheesecake Factory

Marcus Burgess, senior food safety and quality systems specialist at The Cheesecake Factory

“A lot of it is communication and being able to relate at all levels from [in the field] to the top. It’s the 30-second conversation with the server or the dishwasher about why food safety is important. Being able to connect with the front line employees goes a long way. Approach the job with professionalism and sincerity. Have integrity and know the reason why you’re doing what you’re doing. It’s easy to see the pot of gold. Be selfless and know that ultimately our obligations is to customers.”

International Brotherhood of Teamsters

Supplier Accountability Focus of Latest Protest Against Chipotle

By Food Safety Tech Staff
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International Brotherhood of Teamsters

The labor union International Brotherhood of Teamsters has been holding nationwide protests at Chipotle locations this month, taking issue with one of the restaurant chain’s suppliers. The supplier at the focus of the demonstrations is California-based produce company Taylor Farms, which supplies tomatoes and peppers to Chipotle, according to Teamsters.

“Over the past five years, Taylor Farms has had more than 20 food recalls for problems such as Listeria, Salmonella and E. coli. In November 2015, Taylor Farms products containing celery and sold at Costco and other retail outlets were recalled for possible E. coli 0157:H7 contamination,” according to a Teamster news release. “At Taylor Farms’ plant in Tracy, Calif., the company has also committed safety and health violations and violations of laws that protect workers’ rights. Recently, the company settled extensive labor rights violations that involved payments of $267,000 to illegally terminated workers and a required posting in which the company promises to never again violate a long list of employee rights.”

The Teamsters protested at 12 Chipotle locations across the country, following 30 previous protests at Chipotle over the past several months.

Teamster Vice President Rome Aloise points the finger at Chipotle for allowing Taylor Farms to “have a total disregard for consumers’ and workers’ health and safety, as well as workers’ rights,” he said. “Chipotle claims to serve ‘Food With Integrity’, but where’s the integrity when it turns a blind eye to its supplier’s behavior? Chipotle must not cut and run – which would hurt Taylor Farms workers – it must carry out its social responsibility and demand Taylor Farms treat workers fairly and with respect.”

Taylor Farms has not released a statement addressing the protests.

DOJ Launches Criminal Investigation into Dole

By Food Safety Tech Staff
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Learn innovative ways to mitigate the threat of Listeria at the Listeria Detection & Control Workshop | May 31–June 1, 2016 | St. Paul, MN | LEARN MOREOn Friday the news broke that the U.S. Department of Justice (DOJ) was investigating Dole Food Co. over the Listeria outbreak involving packaged salad. The deadly outbreak was linked to salad produced at Dole’s Springfield, Ohio facility. Although the DOJ has not yet commented on the criminal investigation, The Wall Street Journal reports that Dole reported positive Listeria samples at its facility as early as July 2014.

In January 2016, Dole voluntarily recalled all salad mixes produced at the Springfield plant, by which point 33 people in the United States and Canada had fallen ill with Listeria and four had died. The CDC reported on March 31 that the outbreak appeared to be over and Dole restarted production at the Springfield facility in April.

In a press release on the company’s website, Dole stated that the issues FDA reported at its Springfield facility have been corrected. “We have been working in collaboration with the FDA and other authorities to implement ongoing improved testing, sanitation and procedure enhancements, which have resulted in the recent reopening of our Springfield salad plant.” It also acknowledged that it had been contacted by the DOJ related to an investigation and will be cooperating with the department.

FDA

Part of FDA FY 2017 Budget Request to Hold Food Importers Accountable

By Food Safety Tech Staff
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FDA

UPDATE 2/22/2016 – According to an updated FDA alert, the FY2017 budget requests include an increase of $25.3 million of new budget authority to implement FSMA, with FDA focusing on two main areas:

  • National Integrated Food Safety System  ($11.3 million). Support state capacity to implement the produce safety rule via education and technical assistance to farmers and on‑going compliance support and oversight
  • New Import Safety Systems ($14.0 million). Implementing the FSVP rule, which makes importers responsible for ensuring that the foods they bring in from other countries are produced in a manner that is consistent with U.S. food safety standards

– END UPDATE –

FDA wants 8% more money for its FY 2017 budget, requesting a total of $5.1 billion.  Part of this $14.6 million net increase in budget authority will go toward FSMA implementation. Specifically related to food safety, FDA is asking for more than $18.4 million in budget authority and more than $193.2 million in user fees. According to an FDA press release, the agency will be using the budget to support federal and state efforts related to enforcing safety standards on produce farms. In addition, FDA wants to use the money “to hold importers accountable for verifying that imported food meets U.S. safety standards, as well as conduct food safety audits of foreign food facilities”.

FDA is also requesting more than $3 million for building and facilities funding, and more than $600,000 to support other areas to improve the agency’s infrastructure. The fiscal request is for October 1, 2016 through September 30, 2017.

Food Safety Tech

Most Popular Stories of 2015

By Food Safety Tech Staff
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Food Safety Tech
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.

5: FSMA’s FSVP: Clearing the Confusion of Importing Rules

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.

4: When Someone Dies, It’s Not Business as Usual

“His actions resulted in technically more deaths than that of Charles Manson,” said Darin Detwiler, senior policy coordinator for food safety at STOP Foodborne Illness.

3: Marijuana Edibles: Update on a Rapidly Developing Market

Marijuana has catapulted into mainstream thinking via activism, state decriminalization, and medical reforms while investors and banks are beginning to trust the market more, further legitimizing the nascent industry

Steward Parnell, PCA, salmonella outbreak
Stewart Parnell sentenced to 28 years in prison.

2: Food Safety Culture: Measure What You Treasure

A renewed recognition of the importance of individual employee behavior within food processing and manufacturing organizations is shining a spotlight on awareness and accountability, but a standardized measure of food safety culture must be defined.

1: PCA Executives Sentenced: Stewart Parnell Gets Virtually Life in Prison

The landmark case sets a precedent for the food safety industry.

Fontanazza and Fields

Food Companies: Know Your Suppliers

By Food Safety Tech Staff
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Fontanazza and Fields

Read the Q&A with Randy Fields, “Senior Execs in for a Rude Awakening Regarding Supply Chain Compliance”Both accountability and liability will play a role in how food companies work with their suppliers moving forward. “The global food supply chain has really been based on trust for the last 70 years,” said Randy Fields, chairman and CEO of Park City Group and Repositrak. In a video interview with Food Safety Tech at the 2015 Food Safety Consortium, Fields explains how companies must go beyond simply “trusting” their suppliers to having a keen awareness of their suppliers’ activities from a compliance perspective.

 

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.

Top 10 Tips for Creating a Sustained Food Safety Culture

By Holly Mockus
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After much anticipation, FDA has finally published the FSMA final rules. If you’ve had time to dig into the details, you most likely noted the new initiative that requires companies to measure food safety culture. The industry is also seeing SQF, BRC and other GFSI audit schemes ramping up discussions around measuring food safety culture. However, FDA and GFSI audits aside, how do you create a culture for sustained compliance with this initiative? Follow these 10 tips to ensure your food safety culture is constant and in line with the new requirements

Photo credit: Dennis Burnett for Alchemy Systems
Set clear expectations for employees across the board. Photo credit: Dennis Burnett for Alchemy Systems

1: Create a solid foundation of programs, procedures and policies

Have a preset annual schedule for review and update of all programs, procedures and policies. Don’t let the schedule slide because there are competing priorities. A small pebble is all it takes to start ripple effect in the company, making it difficult to recover.

2: Set clear expectations, driven from the top down

Everyone should follow the rules and guidelines—from visitors to the CEO to the plant manager to the hourly employee. A “no exceptions” policy will drive a culture that is sustainable and drive a “this-is-just-how-we-do-things” mindset.

3: Use record keeping to ensure that food safety culture is well documented and data-driven

Collect the data that is measureable and non-subjective to help drive continuous improvement. If you collect it, you must do something with it. Good documentation is imperative to proving you did what you said you were going to do, especially in the event of an audit. Be stringent in training, and review all documentation before it hits the file cabinet to ensure it is accurate and appropriate.

4: Implement a robust continuous improvement process

Forward momentum through a continuous improvement process cannot be achieved unless management nurtures the program. If you are not continuously improving, you are falling behind.

5: Have a 360-degree approach to employee engagement with 24/7 awareness and communication

Top-down communication is critical to highlighting the priorities and needs of an organization and will not be effective unless an organized program is in place. Organizations that are not making the necessary pivots to communicate with the multiple generations within their workplace today will struggle to sustain change.

6: Foster an atmosphere of mutual respect

Treat people as you would like to be treated, turn the other cheek, etc. There may be lots of adages you quote, but which one best describes your facility and the relationships with management and peers on a daily basis?

7: Be sure employees have consumer awareness for the products they produce

Do your employees know who the end consumer is of the product that they are producing every day?  Does your culture include a review of consumer complaints and customer complaints with your frontline workers?  Listening in to a call center is a very powerful way to help employees understand what affects consumers and how their job is critical to avoiding a food safety or quality issue.

8: Create accountability across the board

Hold folks who do not support the culture in which you are striving to develop or maintain accountable, regardless of their position or stature.

9: Provide positive reinforcement. It’s the best motivator

Work to catch people doing things right and make a big fuss when you do. Positive reinforcement for a job well done is the most powerful motivator. It helps keep every team member on board with food safety commitments.

10: Celebrate often

We spend too much time at work not to celebrate all the good things that are accomplished. Whether it’s a cake and recognition for those that served in the armed forces on Veterans Day or a successful launch of a new product—celebrations are a great way to recognize and reinforce your employees’ hard work. Identifying and correcting mistakes should also be celebrated; they are fertile ground for making changes and provide great nutrients for continuous improvement.

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.