2019 Food Safety Consortium, Glenn Black, CFSAN, FDA

Say What? Perspectives We Heard at the 2019 Food Safety Consortium

By Maria Fontanazza
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2019 Food Safety Consortium, Glenn Black, CFSAN, FDA

Last week’s seventh annual Food Safety Consortium brought together a variety of industry experts to discuss key topics around regulation, compliance, leadership, testing, foodborne illness, food defense and more. The following are just a few sound bytes from what we heard at the event. (Click on any photo to enlarge)

Food Safety Consortium, Frank Yiannas, FDA “The food system today, while it’s still impressive, it still has one Achilles heel—lack of traceability and transparency.” – Frank Yiannas, deputy commissioner for food policy & response, FDA. Read the full article on Yiannas’ keynote session

“A typical food company only has about 5% visibility into known supply chain threats.” – Ron Stakland, senior business development, FoodChain ID, Inc.

“For most of us, our supply chain is a big black hole. Why are we so fearful of technology? Is it the implementation itself? What if technology could help us solve some of those perennial problems? There are resources available to help us get there.” – ¬ Jeremy Schneider, business development director, food safety and quality assurance, Controlant

“The records tell the story of how well the facility is being managed. It’s the first thing the regulators are going to look at.” – Glenn Black, Ph.D., associate director for research, CFSAN, FDA, on validation considerations and regulations for processing technologies in the food industry 2019 Food Safety Consortium, Glenn Black, CFSAN, FDA

“We’ll see more robotics enter the food space.” – Gina Nicholson Kramer, executive director, Savour Food Safety International

Melody Ge, Corvium, 2019 Food Safety Consortium “Changes are happening; you can choose to face it or ignore it. We’re at least 10 years behind on technology. Automation/technology is not a new term in aerospace, etc., but to us [the food industry], it is. We will get there.” – Melody Ge, head of compliance, Corvium, Inc., on how industry should prepare for the data-driven transformation occurring in the smarter era of food safety

It’s okay to risk and fail, but how are going to remediate that with your employee? The more learners practice in different scenarios, the less they rely on specific examples. [They] become more adept with dealing with decision making.” – Kathryn Birmingham, Ph.D., VP for research and development, ImEpik, on employee training

“As a contract lab with the vision of testing for foodborne viruses for about 10 years—it wasn’t until about three or four years ago that we had the test kits to turn that into a reality. We also didn’t have a reference method.” – Erin Crowley, chief scientific officer, Q Laboratories, on the viral landscape of testing in the food industry

“You have to be strong and you have to believe in yourself before you get into any situation—especially as a food safety professional.” – Al Baroudi, Ph.D., vice president of quality assurance and food safety at The Cheesecake Factory, on what it takes to earn respect as a food safety professional Jorge Hernandez, Al Baroudi, Ph.D., 2019 Food Safety Consortium

“’See something, say something’ is likely not enough. We recommend that companies develop a formal detection program that includes management buy-in, HR and governance, and policy documents, formal training and an awareness program…While FDA focuses on the insider threat, we feel that using a broader mitigation approach works best.” – R. Spencer Lane, senior security advisor, Business Protection Specialists, Inc. on lessons learned from food defense intentional adulteration vulnerability assessments

“Food safety is a profession, a vocation, [and] a way of life.” – Bob Pudlock, president of Gulf Stream Search

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.”

Food Safety Consortium, Frank Yiannas, FDA

Industry in Midst of a Revolution, Tech Must Help Advance Food Safety, Says FDA

By Maria Fontanazza
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Food Safety Consortium, Frank Yiannas, FDA

The industry has evolved quite a bit since FSMA was passed eight years ago, and there’s been an overarching recognition that more modern methods to addressing food safety challenges—especially traceability—are essential. “The agency is at the threshold of a sea change in how we’re going to oversee food safety in the nation’s food supply,” said Frank Yiannas, deputy commissioner for food policy & response at FDA at the 2019 Food Safety Consortium. The first driver is the FDA’s new initiative announced earlier this year, coined the “New Era of Smarter Food Safety”. The agency will be looking at how new and emerging technologies can help advance food safety.

“I believe that we’re in the midst of a food revolution,” said Yiannas, pointing to the level of investment in food globally. “Products will be reformulated… new food sources and production approaches will be realized, and the food system will become increasingly digitized.” It will be the job of food safety professionals to adapt to this changing landscape and to ensure that innovation does in fact happen (and safely) in order to feed the growing population.

FDA is taking a new mindset that builds on the success of FSMA but also leverages a people-led, technology enabled method to get there. Just a few days ago the agency launched FDA-TRACK, a new food safety dashboard through which FDA intends to track and measure the performance of the seven FSMA rules—and these measurements will be publicized and available for all stakeholders. Initial available metrics will be tracking outcomes for the FSMA Preventive Controls and the Foreign Supplier Verification Program related to inspections and recalls.

The second driver of this sea change at the FDA involves a shift in its current approach to FSMA and the evolution of the regulation. While the agency continues to educate while it regulates, this past summer FDA took actions that are indicating a shift in its approach to FSMA compliance. On July 30, FDA issued its first warning letter using FSVP authorities to a tahini importer for lack of FSVP compliance. This was followed a month later by actions surrounding the most recent Salmonella outbreak linked to imported papaya. “If you pause and look back, there have been eight outbreaks in eight years,” said Yiannas. The outbreak involved 500 documented cases, 100 hospitalizations and two deaths. “I thought, enough is enough,” he added, and this prompted Acting FDA Commissioner Ned Sharpless, M.D. and Yiannas to issue a statement asking the papaya industry to do more—and urged them to work together to review their practices and make necessary changes to ensure that the papayas they’re offering to the public are safe. The FDA also issued a warning letter to the papaya importer, with the possibility of barring the company for the next five years. “When there’s a public health hazard, FDA will act decisively,” said Yiannas, stating that parity and oversight is important, and domestic and imported food must be safe. “We regulators, we’re going to strike the right balance, and are committed and as passionate as ever in trying to bend the foodborne illness curve.”

Yiannas added that over the next eight years, the trajectory of papaya-related illness will look very different from the last eight years, thanks to the adoption of better technologies—and that’s part of what the FDA’s New Era of Smarter Food Safety is about. “The food system today, while it’s still impressive, it still has one Achilles heel—lack of traceability and transparency,” said Yiannas. There’s a lack of knowledge in where food comes from, where it’s produced, and the fact that many companies simply don’t know as much about their supply chains as they think. With FSMA, Congress anticipated the need to track and trace food, and now the agency is exploring how new technology can enhance tracking and tracing. With regards to tracking foodborne illnesses, the food industry has been in a race between detection and prevention. “We’re getting so good at finding the needle in the haystack, but we can’t find the haystack,” said Yiannas. “We have to provide the same level of investment for technologies for trace backs….we will do that together.”

Food Safety Consortium, Frank Yiannas, FDA
Frank Yiannas, FDA deputy commissioner for food policy & response, addresses the ways that the public and private sector must work together as part of the agency’s initiative, the New Era of Smarter Food Safety during the 2019 Food Safety Consortium (Image Credit: amybcreative)

When looking at implementing smarter tools and approaches for prevention, the industry needs to work together at not just collecting the data but also converting this data into actionable information. Yiannas emphasized that the agency is not chasing the shiny object—new technology will not be a distraction; it will help solve industry problems and address the new issues that arise with the evolving food system (i.e., cell-cultured meat, plant-based meat, etc.). The agency is also holding a public meeting on October 21 to encourage discussion between the public and private sector, all surrounding this new initiative on smarter food safety.

“What’s become clear to me is [that] there’s so much we an do working together—the public and private sector… Think. Think about how you can do your work differently,” said Yiannas. “We’re all working for the same boss, the consumer. [We have the] same mission and they’re counting on us.”

2019 Food Safety Consortium, Bayer

Moments from the 2019 Food Safety Consortium

By Food Safety Tech Staff
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2019 Food Safety Consortium, Bayer

The 7th annual Food Safety Consortium Conference & Expo featured dynamic discussions both in the sessions as well as on the exhibit floor. A special thank you to our Advisory Board, who contributed tremendously to the educational content, as well as our sponsors and exhibitors. (Click on the images to enlarge)

All image credit: amyBcreative

FDA

FDA Updates Food Defense Plan Builder to Support Compliance with Intentional Adulteration FSMA Rule

By Food Safety Tech Staff
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FDA

Attend the Food Defense Plenary Panel Discussion at the 2019 Food Safety Consortium | Tuesday, October 1, 2019Today FDA released an updated version of its Food Defense Plan Builder in efforts to help companies comply with the International Adulteration FSMA rule. Version 2.0 of the tool includes the following sections to help food facility owners and operators in developing a facility-specific food defense plan:

  • Facility Information
  • Process/Product Description
  • Vulnerability Assessment
  • Mitigation Strategies
  • Food Defense Monitoring Procedures
  • Food Defense Corrective Action Procedures
  • Food Defense Verification Procedures
  • Supporting Documents
  • Signature

The tool is for use on a computer, and FDA states that it does not have access to any content or documents used with the tool, nor does it track or monitor how the tool is being used. The agency also emphasizes that use of this tool is not required by law and its use does not mean that a company’s food defense plan is FDA approved or compliant with the IA rule requirements.

The original version of this tool was released in 2013. FDA will be conducting a demonstration of the Food Defense Plan Builder v. 2.0 during a webinar on October 10.

AFSAP

FDA Issues First Import Alert for FSVP Non Compliance

By Trish Wester
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AFSAP

The Import Alert for FSVP noncompliance is applicable to any human and animal food subject to the FSVP regulation, and allows FDA to detain imported foods at the port of entry under the protocol for Detention Without Physical Examination (DWPE). DWPE is a standard enforcement tool for FDA.

July 31, 2019: FDA issued Import Alert #99-41, the first Import Alert based on noncompliance with the Foreign Supplier Verification Program (FSVP) regulation.
The FSVP Import Alert contains the following reason for the alert and the relevant charge.

Reason

“Section 805 of the FD&C Act (21 U.S.C. 384a) requires each importer of food to perform risk-based foreign supplier verification activities for the purpose of verifying that the food imported by the importer is produced in compliance with the requirements of section 418 (21 U.S.C. 350g) (regarding hazard analysis and risk-based preventive controls) or section 419 (21 U.S.C 350h)(regarding standards for produce safety) of the FD&C Act, as appropriate; and that the food is not adulterated under section 402 or misbranded under section 403(w).” – FDA

Charge

“The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in that it appears that the importer (as defined in section 805 of the FD&C Act) is in violation of section 805.” – FDA

Join Trish Wester for the closing plenary 2019 Food Safety Consortium panel discussion FDA Presentation on The Third-Party Certification Program | Thursday, October 3, 2019“Import alerts inform the FDA’s field staff and the public that the agency has enough evidence to allow for Detention Without Physical Examination (DWPE) of products that appear to be in violation of the FDA’s laws and regulations. These violations could be related to the product, manufacturer, shipper and/or other information,” states FDA on its webpage about import alerts.

A Trend of Increased Import Enforcement?

FDA enforcement actions in this area have recently seen a dramatic increase. Only one alert was posted in the first quarter, and less than 10 food-related alerts were posted prior to June. July 2019 saw eight food alerts, including one on radionuclides and the FSVP. FDA posted more than 30 food-related import alerts in August, and September is on a similar pace currently showing 21 food-related alerts, indicating this may be an ongoing focus for the agency.

The information in this update is provided by AFSAP, the Association for Food Safety Auditing Professionals. Please contact Patricia Wester @ trish@pawesta.com if you have any questions regarding DWPE, or to request a complete copy of the alert.

FDA

FDA’s Pesticide Analysis Finds Most Foods Tested Below EPA Tolerance Levels

By Food Safety Tech Staff
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FDA

Today FDA released the results of its yearly report on pesticide residues, and the good news is that of the 6504 samples taken, most of them were below EPA tolerance levels. As part of the Pesticide Residue Monitoring Program for FY 2017, FDA tested for 761 pesticides and industrial chemicals in domestic and imported foods for animals and humans. The following are some highlights of the FDA’s findings:

  • Percentage of foods compliant with federal standards
    • 96.2% of domestic human foods
    • 89.6% of imported human foods
    • 98.8% domestic animal foods
    • 94.4% imported animal foods
  • Percentage of food samples without pesticide residues
    • Milk and game meat: 100%
    • Shell egg: 87.5%
    • Honey: 77.3%
  • Percentage of food samples without glyphosate or glufosinate residues
  • Milk and eggs: 100%
  • Corn: 82.1%
  • Soybeans: 60%

“Ensuring the safety of the American food supply is a critical part of the work of the U.S. Food and Drug Administration. Our annual efforts to test both human and animal foods for pesticide residues in foods is important as we work to limit exposure to any pesticide residues that may be unsafe,” said Susan Mayne, Ph.D., director of FDA’s CFSAN, in an agency release. “We will continue to do this important monitoring work, taking action when appropriate, to help ensure our food supply remains among the safest in the world.”

Matrix Sciences and Savour Food Safety International

Matrix Sciences Acquires Savour Food Safety International and Savor Safe Food

By Food Safety Tech Staff
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Matrix Sciences and Savour Food Safety International
Gina Kramer
Gina (Nicholson) Kramer, executive director of Savour Food Safety International

Matrix Sciences International, Inc. has announced the acquisition of Savour Food Safety International and Savor Safe Food, organizations that provide consulting, auditing and training services in food safety and quality, and product development.

“Gina and her teams have built two strong companies with outstanding reputations that come from providing a unique level of service to their customers,” said Robert Wiebe, CEO of Matrix Sciences, in a company press release. “This strategic investment adds to the scope and depth of our Advisory business and has real linkage to our other services. ” Gina (Nicholson) Kramer is the executive director of Savour Food Safety International and also a member of Food Safety Tech’s Editorial Advisory Board. She will continue to serve in the same role and said the acquisition will not change how Savour Food Safety does business. However, the deal will give the firm access to new services, including laboratory testing, process validation, environmental monitoring program assessments, and R&D and sensory testing. “Matrix Sciences is creating an unparalleled team of expert services to provide customers with resources of a large company while maintaining a very focused, personalized approach to service for every client,” said Kramer.

Matrix Sciences has operations nationwide to address the needs of food and beverage industries and has grown through acquisitions of Richter International and Neumann Risk Services as well.

Gina (Nicholson) Kramer will be moderating Salmonella Detection & Control Sanitation Workshop at the 2019 Food Safety Consortium Conference & Expo.

Data protection, security

Threat of Cyberattacks to Food Safety on the Rise

By Food Safety Tech Staff
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Data protection, security

A new report released by the University of Minnesota’s Food Protection and Defense Institute warns that the food industry is vulnerable to cyberattacks, suggesting that food companies need to beef up their security and IT systems. According to the report, “Adulterating More Than Food: The Cyber Risk to Food Processing and Manufacturing”, the systems that food companies use for processing and manufacturing could be the most vulnerable and as such, serve as an attractive target for an attack—especially as industries that are currently common targets improve their cybersecurity.

“The food industry has not been a target of costly cyberattacks like financial, energy, and health care companies have,” said Stephen Streng, lead author of the FPDI report, in a news release. “However, as companies in those sectors learn to harden their defenses, the attackers will begin looking for easier victims. This report can help food companies learn about what could be coming their way and how to begin protecting themselves.”

The report calls out that in 2011, researchers and manufacturers found more than 200 vulnerabilities in industrial control systems. In addition to the fact that these vulnerabilities are in many components from different vendors, many of these systems have obsolete operating systems and passwords that are easy to hack. Compounding this issue, “Companies often lack knowledge about how their industrial control systems and IT systems interact and lack awareness about cyber risks and threats,” the FPDI release notes.

And if you’re a small company, don’t think you’re immune, the report cautions. It cites that 74% of U.S. food manufacturers have fewer than 20 employees—yet software company Symantec Corp. points out that small companies have been targeted as often, or sometimes even more, than large companies.

How can food companies address this risk? The report recommends the following “critical” steps all companies should take:

  • Bridge the gap and facilitate more communication between OT (operational technology) and IT (information technology) personnel
  • Conduct risk assessments of inventory control systems and IT systems
  • Ensure that staff with the cybersecurity knowledge is involved in procuring and deploying inventory control system devices
  • Incorporate cybersecurity into your food safety and food defense culture.

FPDI’s full report is available on the organization’s website.

FDA

FDA and NASDA Collaborate on $1.3 Million Produce Safety Program

By Food Safety Tech Staff
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FDA

Yesterday FDA announced a five-year cooperative agreement with the National Association of State Departments of Agriculture (NASDA) to enable more support of developing, implementing and improving programs related to the Produce Safety rule. The agreement will provide funding to help NASDA work with state and territorial produce safety regulatory programs to facilitate the safe production of fresh fruits and vegetables, along with better understanding of the Produce Safety Rule and its requirements.

“This advances the agency’s efforts to develop a nationally integrated food safety system by helping to ensure consistency of state and territorial produce safety regulatory programs with the Produce Safety Rule,” FDA stated in a release.

The current program has $1.3 million in funding. During the first two years of the cooperative agreement, NASDA will work with FDA on implementing and updating the On-Farm Readiness Review system with the agency and its partners in state and territorial produce safety programs. During the third through fifth years of the program, NASDA will help FDA in establishing and promoting a “uniform foundation of produce safety” to help create a national produce safety regulatory program.