FDA Reflects on Monumental Effort of FSMA

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

Palmer Orlandi, FDA, Food Safety Consortium

FSMA and Laying Groundwork for Data Acceptance in Lab Partnerships

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

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

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

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

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

David Hammond, Eurofins, food fraud

Proactive Approach to Preventing Food Fraud

By Food Safety Tech Staff
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David Hammond, Eurofins, food fraud

Several different approaches can be used to verify authenticity of food, from a heteroduplex assay to microsatellite analysis. In part II of a presentation by fruit juice and authenticity expert David Hammond, Ph.D. of Eurofins Scientific at the 2015 Food Labs Conference, learn about the DNA methodologies as well as the proactive steps that companies should be taking to prevent food fraud or economically motivated adulteration of product.

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

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

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

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

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

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

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

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

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

All images by amyBcreative photography.

FDA’s Michael Taylor Joins in Honoring Food Safety Heroes

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

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

All images by amyBcreative photography

A Multi Residue Pesticide Method using Ion Chromatography-Mass Spectrometry for Polar Ionic Pesticides. A Dream or Reality?

Some polar ionic pesticides and their associated metabolites are not “amenable” to common multi residue methods, such as QuEChERS. These compounds need alternative extraction conditions for improved recovery and/or alternative separation conditions for improved retention and/or peak shape. Currently the polar pesticides tend to be treated as a series of selective single residue methods adding significant cost to the analysis and therefore, are often excluded from pesticide monitoring programs. At Fera we have coupled the QuPPe generic extraction conditions with determination by suppressed ion chromatography tandem quadrupole mass spectrometry. This presentation will describe our experiences and challenge faced in implementing this method, presenting validation data in a cereals matrix. View the presentation here.

Don’t Let Fraud Turn Fruit Juice Sour

By Food Safety Tech Staff
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In 2009, FDA officially recognized food fraud as an issue. Driving forces behind the problem include seeking an opportunity to make an illicit profit, a lack of premium raw materials, and a lack of supplier awareness. At the 2015 Food Labs Conference, fruit juice and authenticity expert David Hammond, Ph.D. of Eurofins Scientific offered the basics of protecting against the adulteration of fruit juices.

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

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

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

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

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

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

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

Strong Prerequisite Programs Half the Battle in FSMA Compliance

By Maria Fontanazza
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Debby Newslow

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

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

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

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

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

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

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

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

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