Frank Yiannas, FDA, Food Safety Summit, Food Safety Tech

Can We Make Progress Before the Next Food Safety Crisis?

By Maria Fontanazza
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Frank Yiannas, FDA, Food Safety Summit, Food Safety Tech

A recall or outbreak occurs. Consumers stop buying the food. Industry responds with product innovation. Government enters the picture by establishing standards, initiatives, etc. “That’s my thesis about how changes happen,” said Michael Taylor, board co-chair of Stop Foodborne Illness during a keynote presentation at last week’s Food Safety Summit. Industry has seen a positive evolution over the past 25-plus years, but in order to continue to move forward in a productive direction of prevention, progress must be made without waiting for the next crisis, urged the former FDA commissioner for foods and veterinary medicine.

The strong foundation is there, Taylor added, but challenges persist, including:

  • FSMA. There’s still much work to be done in establishing accountability across the board, including throughout supplier networks.
  • Lack of technology adoption. The failure to use already available tools that can help achieve real-time traceability.
  • Geographic hazards. This is a reference to the contamination that occurred in the cattle feedlot associated with the romaine lettuce outbreak in Yuma, Arizona. “We’re dealing with a massive hazard…and trying to manage the scientific ignorance about the risk that exists,” said Taylor. In addition, in February FDA released its report on the November 2018 E.coli O157:H7 outbreak originating from the Central Coast growing region in California, also implicating contaminated water as a potential source. “There are still unresolved issues around leafy greens,” Taylor said. “What are we going to learn from this outbreak?”

Taylor went on to emphasize the main drivers of industry progress: Consumers and the government. Consumer expectations for transparency is rising, as is the level of awareness related to supply chain issues. Social media also plays a large role in bringing consumers closer to the food supply. And the government is finding more outbreaks then ever, thanks to tools such as whole genome sequencing. So how can food companies and their suppliers keep up with the pace? A focus on building a strong food safety culture remains a core foundation, as does technological innovation—especially in the area of software. Taylor believes one of the keys to staying ahead of the curve is aggregating analytics and successfully turning them into actionable insights.

Frank Yiannas, FDA, Food Safety Summit, Food Safety Tech
Frank Yiannas is the keynote speaker at the 2019 Food Safety Consortium | October 1, 2019 | Schaumburg, IL | He is pictured here during at town hall with Steven Mandernach (AFDO), Robert Tauxe (CDC), and Paul Kiecker (USDA)

FDA recently announced its intent to put technology innovation front and center as a priority with its New Era of Food Safety initiative. “This isn’t a tagline. It’s a pause and the need for us to once again to look to the future,” said Frank Yiannas, FDA’s deputy commissioner for food and policy response during an town hall at the Food Safety Summit. “The food system is changing around us dramatically. Everything is happening at an accelerated pace. The changes that are happening in the next 10 years will be so much more than [what happened] in the past 20 or 30 years…We have to try to keep up with the changes.” As part of this “new era”, the agency will focus on working with industry in the areas of digital technology in food traceability (“A lack of traceability is the Achilles heel of food,” said Yiannas), emerging technologies such as artificial intelligence and machine learning, and e-commerce. Yiannas said that FDA will be publishing a blueprint very soon to provide an idea of what areas will be the main focus of this initiative.

Question mark

The Results Are In: FSMA Supply Chain IQ Test (Part II)

By Food Safety Tech Staff
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Thank you to everyone who participated in our latest FSMA IQ test, which focused on the supply chain. This series was developed by Kestrel Management. If you have any questions about the results, we encourage you to leave a comment.

We also invite you to learn more about important supply chain issues at our Food Safety Supply Chain Conference later this month, May 29–30. You can attend in person or virtually.

If you haven’t taken Part II yet, take the Supply Chain IQ Test now.

And now for the results!

  1. Control limits must be included within the hazard analysis and preventive controls for HACCP.
    • FALSE. More clarification is needed here, as 96% of respondents said this is true.
  2. CCPs previously established under HACCP or previous hazard analysis may be a preventive control under FSMA.
    • TRUE. 91% got this right.
  3. Product testing for pathogen or indicator organism is not addressed under FSMA verification and reevaluation.
    • FALSE. 87% answered correctly.
  4. You must document justification of records not required by a food safety plan in a food operation under FSMA.
    • TRUE. Just 44% responded “true”.
  5. You must implement corrective actions and corrections properly, including procedures to address the presence of organizations in ready-to-eat as a result of product testing.
    • TRUE. Congratulations, 100% got this one right!
  6. Under section 117.150, you must implement corrective actions based on your determined response for all affected food as evaluated.
    • FALSE. This seems to be another area that needs clarity: Just 13% answered “false”.
  7. Under FSMA supply chain requirements, you must document approved suppliers.
    • TRUE. Once again, great job—100% answered correctly!
  8. A foreign supplier of food to the U.S. must ensure that all the requirements of a FSMA Food Safety Plan under cGMP117.126 be met for the manufacture of the food being exported to the United States.
    • TRUE. 91% knew this one.
  9. A food broker of foreign-supplied product to the U.S. does not have any responsibility of meeting the FSMA requirements.
    • FALSE. 91% answered correctly.
  10. Data sets must be shared between shippers, carriers, loaders & receivers to ensure rules are properly implemented.
    • TRUE. 74% answered correctly.
  11. Only the personnel of the carriers transporting food product require training and training records.
    • FALSE. 96% got this one right.
  12. Shipper & carrier can agree to a condition & temperature monitoring mechanism for foods that requires temperature control for safety.
    • TRUE. 91% answered correctly.
Rodent, Bayer, Digital pest management

Trapped Checking Traps: An Expert Details How Current Pest Monitoring Programs can Let You Down

Rodent, Bayer, Digital pest management

“Simply put, the Food Safety Modernization Act (FSMA) means that it’s no longer acceptable to have a reactive food safety policy. There is a new emphasis on proactive measures to safeguard public health.

That said, whether your pest control is managed in-house, or you hire a professional pest management company, odds are “service” is focused on the rote practice of trap checking, which is neither cost-effective, nor does it provide the holistic IPM strategy that focuses on proactive inspections that ensure FSMA compliance.

You should be challenging your service provider, holding them to the standard of this new obligation. To understand the state of the industry and what food managers need to be considering when it comes to rodents, I contacted Richard Kammerling, founder of RK Pest Management Services, whose half-century of experience gives him a unique vantage on the hallmarks of an expertly managed food safety program – past, present and future.

Joe Barile: How would you characterize the current state of the industry?

Richard Kammerling: The food industry has a problem where they sometimes assume everything is fine even when it’s not. And sometimes they’re not willing to pay the price to make sure their program is working properly until they have a real problem. One of the biggest problems in the food industry is they underestimate the time that is needed to properly perform a pest management program. The food industry tends to be reactive rather than proactive. If they’re not given the information to know a condition could be or is an issue, then they don’t address it as such.

Barile: So, what should food managers be requiring from service providers?

Kammerling: Service providers should be acting as diagnosticians. Say, through trap-checking, we found one mouse in a trap. Is it only one mouse? Or is it an infestation? What are the conditions that caused it? Most of the pest control industry is going around the perimeters, but they’re not doing the entire scope of the food warehouse.
If you can find a pest-vulnerable condition and eliminate it, that’s the key to an effective IPM program. Collecting data can help you find some of these conditions, but analysis of that data and inspections are key to a pest management program – and that’s what food safety managers should be demanding of their pest managers, internal or external. Most pest control today is based on trap checking and does not leave enough time for inspections or data analysis….”

Read the full interview, “Industry Insights, The Future of Rodent Control“.

Question mark

FSMA Supply Chain IQ Test (Part II)

By Food Safety Tech Staff
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Food Safety Tech’s FSMA Supply Chain IQ test series continues with Part II. The test was put together by the subject matter experts at Kestrel Management, LLC. Before taking Part II, let’s review the results from Part I below. (If you have not taken Part I, take the test now!)

  1.  FSMA requires all records for the reevaluation of cGMPs every three years.
    • FALSE. Only 28% knew this.
  2. Implementation records are required for every FSMA requirement.
    • TRUE. 74% got this right.
  3. Under some circumstances, FSMA requires that conformance of a customer’s control of a hazard is required.
    • TRUE. 90% answered correctly.
  4. Under FSMA cGMPs, you must be able to identify at least 95% all possible contaminated product.
    • FALSE. Respondents were almost evenly split. 51% answered correctly.
  5. Monitoring of frequency of preventive controls must be conducted by the operation as part of the food safety plan.
    • TRUE. 92% answered on target.
  6. Written supply chain plans are not included in FSMA food safety plans.
    • FALSE. 81% answered correctly.
  7. Mandatory recalls are provided under FSMA as a new requirement.
    • TRUE. 63% answered correctly.
  8. Verification effectiveness of the implementation of preventive controls needs to be evident but not documented under FSMA.
    • FALSE. 74% got this right.
  9. cGMPs under FSMA require that outer garments be suitable to protect against allergen contamination.
    • TRUE. 77% answered correctly.
  10. You do not need to document records of all product testing under FSMA.
    • FALSE. 82% answered correctly.
  11. FSMA preventive controls does not require hazards be addressed under the HACCP plan.
    • FALSE. 69% got this right.
  12. The food safety plan does not require hazards that are unintentionally introduced within an operation’s processes.
    • FALSE. 82% answered correctly.

Surprised by the results? Provide feedback in the comments section.

We invite you to take Part II below and then learn more about important supply chain issues at our Food Safety Supply Chain Conference, May 29–30. You can attend in person or virtually.

Create your own user feedback survey

Tyson ready-to-eat chicken strips, May 2019 recall

Tyson Recall of RTE Chicken Strips Hits 11.8 Million Pounds

By Food Safety Tech Staff
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Tyson ready-to-eat chicken strips, May 2019 recall
Tyson ready-to-eat chicken strips, May 2019 recall
One of the Tyson products involved in the recall. FSIS has provided a list of all the labels on its website.

Over the weekend Tyson Foods, Inc. announced an expanded voluntary recall of its frozen, ready-to-eat chicken strips due to more issues involving contamination with metal fragments. The initial recall occurred on March 21 and involved 69,093 pounds of product. All RTE chicken strips under the Class I recall have the establishment number “P-7221” on the product package and were produced between October 1, 2018 and March 2019, with “Use By Dates” of October 1, 2019 through March 7, 2020. The products were shipped nationwide to retail and Department of Defense locations, as well as to the U.S. Virgin Islands.

“Our company is taking corrective action at the location that makes these products. We have discontinued use of the specific equipment believed to be associated with the metal fragments, and we will be installing metal-detecting X-ray machinery to replace the plant’s existing metal-detection system. We will also be using a third-party video auditing system for metal-detection verification,” said Barbara Masters, DVM, vice president of regulatory food policy, food and agriculture for Tyson Foods in a company news release.

Thus far there have been six consumer complaints involving metals pieces, with three people claiming oral injury.

FSIS has provided images of the product labels involved in the recall.

Ned Sharpless, Frank Yiannas, FDA

FDA’s ‘New Era of Smarter Food Safety’ to Focus on Traceability, Digital Technology and E-Commerce

By Food Safety Tech Staff
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Ned Sharpless, Frank Yiannas, FDA

“It’s time to look to the future of food safety once again,” declared Acting FDA Commissioner Ned Sharpless, M.D. and Deputy Commissioner for Food Policy and Response Frank Yiannas in a press statement released yesterday. Although progress has been made in implementing FSMA and with the development of the GenomeTrakr Network, the agency wants to move forward in taking advantage of the innovative technologies that will help make the food supply more digital, traceable and safer. With that effort comes the creation of a “Blueprint for a New Era of Smarter Food Safety”, which will speak to “traceability, digital technologies and evolving food business models”. Sharpless and Yiannas outlined the significant role that these components will play.

Digital technology in food traceability. Digital technologies could play a crucial part in rapidly identifying and tracing contaminated food back to its origin—changing the timespan from days or weeks to minutes or seconds. FDA intends to look at new ways that it can evaluate new technologies and improve its ability to quickly track and trace food throughout the supply chain. “Access to information during an outbreak about the origin of contaminated food will help us conduct more timely root cause analysis and apply these learnings to prevent future incidents from happening in the first place,” stated Sharpless and Yiannas. This means a shift away from paper-based systems.

Ned Sharpless, Frank Yiannas, FDA
(left to right) Ned Sharpless, M.D., FDA acting commissioner and Frank Yiannas, deputy commissioner of food policy and response. Image courtesy of FDA

Emerging technologies. Artificial intelligence (AI), distributed ledgers (no, they didn’t directly say “blockchain”), the Internet of Things, sensors and other emerging technologies could enable more transparency within the supply chain as well as consumer side of things. The FDA leaders announced a pilot program that will use AI and machine learning to assess food imports at the U.S. point of entry.

E-Commerce. “Evolving food business models”, also known as e-commerce, is growing fast and changing how consumers get their food. With food delivery introduces food safety issues such as those related to packaging and temperature control. FDA is exploring how it can collaborate with federal, state and local stakeholders to figure out ways to address these potential problems.

Sharpless and Yiannas emphasized the end-goal in keeping the food of American consumers safe. “So, welcome to the new era of smarter food safety that is people-led, FSMA-based and technology-enabled!”

AFSAP, audits

AFSAP Second Annual Stakeholders Meeting to Be Held During Food Safety Supply Chain Conference

By Trish Wester
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AFSAP, audits

2018 Recap: As VQIP implementation began, confusion among the accreditation bodies (ABs) and certification bodies (CBs) was clearly evident, and options for explanations from FDA were limited. To facilitate information sharing, AFSAP hosted an open gathering of all interested parties to hear from FDA. The inaugural AFSAP Auditing Stakeholders meeting provided a unique opportunity for the auditing community at large to interact with FDA and expand their knowledge on the regulatory use of audits in FSMA. CB attendees gained valuable insight into their hybrid role as part Scheme Owner under the Third-Party Certification Program (TPP) and its operational challenges in the global community. After vigorous discussion, the development of a consensus program for FDA’s TPP audits emerged, although the definitive mechanism to achieve this objective was still to be determined. AFSAP established a membership category for CB’s, and has continued to pursue solutions to these and other audit related issues, but information sharing has been limited to members.

2019: Although progress has been made, there is still a need for information sharing among all interested parties. Once again, the 2nd Auditing Stakeholders Meeting will be co-located with the Food Safety Supply Chain Conference in Rockville, MD, May 29–30, 2019.

AFSAP extends a gracious thank you to them for supporting AFSAP’s mission and goals.

The 2019 Auditing Stakeholder meeting will build on the TPP knowledge base, incorporating other areas that overlap with auditing and auditor development in general. FDA has a new TPP management team participating this year, along with some familiar faces from 2018. Join AFSAP in welcoming them to our event!

We have an exciting agenda planned for this year that includes a members-only session, an at-large session, and updates from FDA’s new TPP team. Association announcements will be provided after the Association’s members meeting has concluded.

AFSAP Membership Meeting

  • Association updates; Accomplishments, Partnerships & Alliances, Plans and Activities
  • Committee Updates
    • The Auditor Development Committee/Chair introductions
  • AFSAP’s Voluntary Consensus Standard (VCS) for FDA’s 3rd Party Audit
  • VCS Board: Introductions and Nominations
    • The review and publication process for a VCS

Auditing Community Meeting Highlights

  • SGS’ Hank Karayan
    • The Accreditation Experience – Lessons Learned
  • Just the FAQ’s – Common questions and misconceptions
  • New! TPP Audit Templates and Auditor Trainings

Contact AFSAP for registration information: info@afsap.org

About AFSAP

The Association for Food Safety Auditing Professionals is a member driven association created to advance and support the professional development of food safety auditors globally. As a 501(c)(3) Trade Association, AFSAP provides a universal platform for individual auditors and the auditing community at large to harness their combined experience and knowledge into a powerful tool equal to the significant challenges that lie ahead. Working together, AFSAP members will have an unprecedented opportunity to engage regulatory agencies and external stakeholders with a unified voice, and collaborate on the development of creative solutions to the issues facing the food safety auditing industry.

About the Food Safety Supply Chain Conference

A food company’s supply chain can be the weakest link in their food safety program. Food ingredient adulteration, fraud, and counterfeiting negatively impacts everyone in the food supply chain. FDA has recognized the risk in the food supply chain. Sanitary transportation and the Foreign Supplier Verification Program (FSVP) are major components of FSMA. The Food Safety Supply Chain Conference addresses best practices, and new tools and technologies that can help food companies, including manufacturers, retailers and food service companies protect their brands and customers from food safety threats in their supply chain while being compliant with regulators.

Question mark

FSMA Supply Chain IQ Test (Part I)

By Food Safety Tech Staff
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Food Safety Tech’s FSMA IQ test series continues with a two-part series that addresses supply chain considerations under FSMA. Once again, the test was put together by the subject matter experts at Kestrel Management, LLC. We invite you to take the 12-question test and then learn more about important supply chain issues at our Food Safety Supply Chain Conference, May 29–30. You can attend in person or virtually.

Results of Part I will be posted next week, at which point Part II will be available.

Create your own user feedback survey

FDA

FDA Says Routine Intentional Adulteration Inspections Will Start March 2020

By Food Safety Tech Staff
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FDA

Learn more about food fraud  at the Food Labs Conference | June 2–4, 2020 | Rockville, MDThis week FDA made an announcement during a public meeting that the agency’s routine inspection to verify compliance with the FSMA Intentional Adulteration rule will start next March.

The first compliance date for the rule is this July. It is a requirement for food facilities covered under this rule to develop and implement a food defense plan that identifies vulnerabilities and the consequent mitigation plan.

FDA stated that it has received feedback on the “novel nature” of the rule’s requirements and that stakeholders want more time to develop their food defense plans. “ To allow industry time with the forthcoming materials, tools, and trainings, and because the IA rule represents new regulatory territory for all of us, we will be starting routine IA rule inspections in March 2020,” FDA stated and added that it is working on developing more resources as well as the final part of draft guidance to continue to assist industry.

Upcoming Web Seminar to Tackle Technologies in Supply Chain Traceability

By Food Safety Tech Staff
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Next month, Food Safety Tech invites you to join us for an afternoon of dynamic discussions about how technology (both emerging and current) can help the industry in its quest for full supply chain traceability. This is a complimentary web seminar. Our lineup of speakers includes Lucy Angarita, director of supply chain traceability for IPC, SUBWAY’s Purchasing Cooperative; Thomas Burke, food traceability and safety scientist at the Institute of Food Technologists; and Sharan Lanini, director of food safety at Pacific International. These subject matter experts will talk about the technologies that enable end-to-end visibility from farm to fork, emerging technologies and the components for success, and how to make the business case for technology adoption to the C-suite. A technology spotlight will follow each session to offer attendees a preview of available solutions that tackle supply chain challenges. You’ll also have the opportunity to ask speakers your questions during three Q&A sessions.

Event Details

Supply Chain Traceability: Using Technology to Address Challenges and Compliance
Tuesday, May 14, 2019
1–4 pm ET
Register for the event

Lucy Angarita, Thomas Burke and Sharan Lanini
Speakers (left to right) Lucy Angarita, Thomas Burke and Sharan Lanini.