Michael Taylor FDA

Food Safety Over Past 25 Years: ‘Everything Has Changed’

By Maria Fontanazza
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Michael Taylor FDA

The effect that the 1993 E. coli O157:H7 outbreak had on the food industry was tremendous. Responsible for more than 600 illnesses and the deaths of four children, the outbreak led to significant changes in the industry’s approach to food safety. “[It] drove a shift in food safety that many had been working toward for years,” said Rima Khabbaz, M.D., acting deputy director for infectious diseases at CDC during the “We Were There” CDC lecture series, adding that the focus moved to food suppliers and how they could make their products safer. “The outbreak drove a paradigm shift that opened the door to food safety,” said Patricia Griffin, M.D., chief of the CDC’s enteric diseases epidemiology branch during the lecture.

Deirdre Schlunegger and Michael Taylor
Deirdre Schlunegger, CEO of Stop Foodborne Illness, and Michael Taylor at Stop event celebrating Food Safety Heroes during the 2015 Food Safety Consortium.

Within a few years, several actions and initiatives paved the way for notable progress. In 1994, Mike Taylor, who was administrator of USDA’s FSIS at the time, made a speech that “shocked and outraged the industry,” said Griffin, where he stated, “we consider raw ground beef that is contaminated with E. coli O157:H7 to be adulterated within the meaning of the Federal Meat Inspection Act.” From there, the USDA worked on legislation that was the first major advance in meat regulation. In 1996 the agency established the Pathogen Reduction Rule to improve meat inspection. The same year CDC’s PulseNet was born, the nationwide lab network that uses DNA fingerprinting to help identify outbreaks early, along with the Foodborne Diseases Active Surveillance Network (FoodNet), an epidemiological system that tracks incidents and trends related to food.

In a Q&A with Food Safety Tech, Mike Taylor, most recently the former FDA commissioner for foods and veterinary medicine, discusses the dramatic change that industry has undergone during the past 25 years, from FSMA to technology advancements to food safety culture.

Food Safety Past, Present and Future at the 2017 Food Safety Consortium: Recognizing the 1993 Jack In the Box E. coli outbreak as the event that propelled the current food safety movement. Mike Taylor, Bill Marler, Esq. and Ann Marie McNamara (Target Corp.), who took the reins from the late David Theno at Jack In the Box, will discuss Theno’s impact on the industry. The session continues through a timeline of the evolution of food safety from 1993 to present, and then the future, where we will cover the IoT, social media, food safety culture and technology. It will be followed by the STOP Foodborne Illness Award Ceremony. Wednesday, November 29, 2017, 4:00–5:30 pm | LEARN MORE

Food Safety Tech: Reflecting on how far the industry has come since the E.coli O157:H7 outbreak involving Jack in the Box in 1993, what key areas of progress have been made since?

Michael Taylor: I think there are very major ones obviously. You have to remember where things were when the Jack-in-the-Box [outbreak] happened. We were in a place where USDA programs said it was not responsible for pathogens in raw meat and that consumers are supposed to cook the product; [and] industry was operating under traditional methods. Microbial methods were typically conducted for quality not for safety; you had the loss of public confidence and a terrible situation in which consumers were pointing at industry, and industry was pointing at consumers, and no one was taking clear responsibility for safety of the product.

Now we are in a completely different environment where not only is there clarity about industry’s responsibility for monitoring pathogens, there’s also been enormous progress by industry to put in place microbial testing, something David Theno pioneered and is now a central part of food safety management systems for meat safety.

Everything has changed.

These [institutional] arrangements exist not only in the meat industry, but now across the whole food industry. There’s the emergence of GFSI taking responsibility for managing the supply chain for food safety, food safety culture taking hold broadly across leading companies in the industry, and FSMA codifying for 80% of the food supply that FDA regulates the principles of risk-based prevention and continuous improvement on food safety.

I think it’s rather dramatic how far the industry’s food safety regulatory system has come since [the] Jack in the Box [outbreak].

FST: How has FSMA helped to align industry priorities?

Michael Taylor FDA
Mike Taylor was on the front lines of change in the meat industry.

Taylor: Let’s focus on the events first leading up to FSMA—for example, the outbreaks or illnesses associated with leafy greens [and] peanut butter, and problems with imported products—those events in the world aligned industry priorities around the need to modernize the food safety laws and to enact FSMA. It was the coming together of industry and consumer interests, and the expert community around the principles of comprehensive risk-based prevention that vaporized into FSMA. Now FSMA is the framework within which companies are organizing their food safety systems in accordance with these modern principles of prevention.

And clearly what’s been codified in FSMA and some of the key elements are becoming organizing principles where industry is aligning our priorities for food safety. Environmental monitoring where that’s an appropriate verification control for a company’s hygiene and pathogen control—that’s clearly a priority that folks are aligning on. The issue of supplier verification for domestic and foreign supply is a priority that has been elevated by FSMA, and so has the whole issue of training and employee capacity, whether it’s in processing facilities or on farms, as well as food safety culture. If you’re going to be effectively preventive you need to deal with the human dimension of your food safety system.

These are examples of ways in which FSMA is aligning industry priorities.

Read the rest of the interview on page 2 (link below).

FSMA

How the Sanitary Transportation Rule Waiver Applies to Retail Food Establishments

By Food Safety Tech Staff
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FSMA

This week the FDA issued another guidance document to explain a waiver to the Sanitary Transportation rule and that it applies to retail food establishments that sell food for humans as well as those that sell both human and animal food. It does not apply to establishments that exclusively sell animal food.

“The Sanitary Transportation rule established a process by which FDA may waive any of the rule’s requirements for certain classes of persons, vehicles, or types of food if doing so will not result in the transportation of food under conditions that would be unsafe for human or animal health, or contrary to the public interest.” – FDA

In April, FDA announced three waivers that apply to businesses with transportation operations subject to State-Federal controls. Since this time, FDA stated that it has received questions regarding whether the term “retail food establishment” also applies to businesses that sell animal food. “The purpose of the guidance document is to clarify that the waiver is intended to apply to establishments that are covered by human food regulations based on the FDA Food Code and administered by state and local authorities,” FDA stated in a news release.

Earlier this month FDA released three guidances related to low-acid canned foods, juice HACCP and seafood HACCP.

Egg

Egg Contamination Spreads Across Europe

By Food Safety Tech Staff
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Egg

At least 17 countries have been hit with the European egg scandal involving insecticide contamination. Ground zero of the problem has not been definitively identified, as Belgium, the Netherlands and Germany are reportedly pointing fingers over which country is to blame and how long they knew about the problem. Dutch authorities may have known about the problem as far back as November 2016.

The eggs have been tainted with the pesticide Fipronil, doses of which are not harmful to humans engaging in short-term consumption. When consumed in large doses, it can cause damage to the kidneys, liver and thyroid glands.

Farmers in the Netherlands used a company, Chickfriend, to delouse their chickens, but this company reportedly mixed fipronil into the cleaning solution and could have contaminated nearly 180 farms in the country as a result, according to The New York Times. As many as 20% of Dutch egg-laying chickens could be affected. Chickfriend was recently raided by authorities and two of its directors were arrested. Antwerp-based Poultry-Vision stated that it provided Chickfriend with fipronil via a source in Romania, according to The Guardian.

Contaminated eggs, which have been distributed to at least 17 countries (mainly in Europe) have also been found at producers in Belgium, France and Germany, and as a result, millions of eggs have either been destroyed or removed from store shelves.

FSMA

FSMA Exempt? FDA Guidances Explain

By Food Safety Tech Staff
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FSMA

This week FDA released three guidances to help food producers understand how the FSMA rules apply to their commodities. The regulations covered in the guidances pertain to low-acid canned foods (LACF), juice HACCP and seafood HACCP. Since FDA’s regulations for HACCP and LACF were in place before the FSMA final rules were established, the agency is clarifying the FSMA requirements as well as exemptions for these products.

The following guidances are available on FDA’s website:

World Factbook of Food

As Food Fraud Grows, More Comprehensive Tools Emerge

By Maria Fontanazza
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World Factbook of Food
World Factbook of Food
The World Factbook of Food is a central reference location for data related for food. (Click to enlarge image of homepage)

Many foods, from honey to olive oil to spices, fall victim to fraudsters each year. Often a time-consuming process, conducting research about each product or ingredient can involve combing through many websites and databases for information. To save companies from doing all that heavy lifting, newer tools are aggregating the data into single platforms. One most recent example is the World Factbook of Food, developed by the Food Protection and Defense Institute (FPDI) and funded by the U.S. Department of Homeland Security. The tool was released earlier this year, and Erin Mann, project manager at FPDI, explains how it is helping food companies mitigate the risk of food fraud in their supply chain.

Food Safety Tech: What are the fundamental advantages of using the World Factbook of Food and how is it different from other tools that companies can use to assess their risk?

Erin Mann: The World Factbook of Food is a central reference location for data related for food. It pulls together a lot of high quality data points from a lot of different sources into a single tool.

Companies can look for information on a lot of different food products and a lot of different sourcing regions and countries. We have more than 125 food profiles (and growing) and more than 75 country profiles (also growing). [There are 10 food profiles and 10 country profiles that are available for free] Each of the profiles covers a large number of topics. On the food profile side, there are data points on how the product is used, codes, information about standards and grades; and a lot of data about trends and consumption, production and trade patterns; there’s information about processing and supply chain characteristics; and another section about food defense and food safety.

Erin Mann, Food Protection and Defense Institute
Erin Mann, Food Protection and Defense Institute

It’s a resource that can be used anytime a company needs to get up to speed quickly on a product, because it covers a lot of different types of risks. If a company wanted access to information related to risk about past economically motivated adulteration (EMA) or intentional adulteration (IA) incidents, the Factbook has that. There’s also data on past recalls, information about major producing countries around the world—a wealth of information in one place that companies can use broadly for risk assessment—basically any use case where they want access to a lot of information from lots of sources, the Factbook can be a great place for that.

FST: Can you expand on the food defense component of the Factbook?

Mann: One of the primary sources that we pull for the food defense section comes from a complementary tool that we use here at FPDI—our food adulteration incidence registry, called the FAIR tool, which is a database of past EMA and IA incidents. On the technology side, the Factbook is directly linked with the FAIR tool. If you’re looking at a profile for a particular product, it will access the FAIR tool and display relevant incidents for that product. It won’t give you access to the entire FAIR database, but it will give you a high-level summary of what food defense incidents have happened in the past with the product, where they happened, the year and a summary.

What we’ve seen with the FAIR tool is high incidents of food adulteration in products like oils, spices, seafood—those are the major products impacted by food adulteration, particularly EMA.

Food Adulteration Incidents Registry
Food Adulteration Incidents Registry (FAIR) tool

FST: From what sources are the data curated?

Mann: There’s a source list at the bottom of each profile and all the data points are referenced throughout. In terms of a high-level description of where we pull data from, it includes the USDA, FDA, Codex, the U.S. International Trade commission, United Nations data, and other industry and trade groups. It also pulls data from the World Bank and the FAIR tool.

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FST: How can companies use the Factbook as part of their overall risk mitigation process?

Mann: One of primary strengths of the Factbook is that companies can use it in many different ways. Our institute has done a lot of work with big data and using multiple data sources, and one of the biggest takeaways we learned through several years in this field is that whenever you use big data or you use lots of data sources, they must produce intelligence and information that is actionable. All of the data and information doesn’t do much good if there’s not a clear summary of what to do with that information.

The Factbook aims to do that. It’s a collection and synthesis of data and clean information that’s in an easy to use and easy to navigate user interface. From there, companies can take a look and see how to use the Factbook where they see a gap in their processes. It’s a great place to access lots of information about a food product in a single place. If we can see several points in an overall risk mitigation process where the Factbook can be used, it could be used to inform decisions related to procurement. [For example], if a company suddenly needed to procure a product from a new source region or if they were developing a new product and had to procure an ingredient that they hadn’t worked with before, the Factbook would be a great place to get smart quickly on that ingredient.

The Factbook could be used for understanding supplier review and specific risks related to that ingredient, or simply horizon scanning—if companies want to take a look at some of the products they’ve determined to be high risk and learn more about the product from a holistic perspective.

As stated in the Q&A, 10 food profiles and 10 country profiles are available for free. Subscribers to the World Factbook of Food pay $600 annually for full access to the tool, and bundled pricing is available for users who are interested in access to both the Factbook and the FAIR tool.

USDA Logo

New Leadership at USDA, Almanza Heads to JBS

By Food Safety Tech Staff
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USDA Logo

Over the past week, the USDA has undergone changes in top leadership. Following 39 years with FSIS, Deputy Undersecretary for Food Safety and FSIS Administrator Al Almanza retired. U.S. Secretary of Agriculture Sonny Perdue announced the appointment of Carmen Rottenberg as acting deputy undersecretary for food safety and Paul Kiecker was named acting administrator for FSIS. Rottenberg and Kiecker will serve in these roles until presidential nominees are confirmed by the Senate.

“Highlights for me have been using a science-based approach to modernize the poultry slaughter inspection system, implementing the Public Health Information System (PHIS), reducing listeriosis and E. coli O157:H7 illnesses from FSIS-regulated products and adding six other dangerous strains of E. coli to the zero-tolerance list, and implementing performance standards for Campylobacter and Salmonella.” – Al Almanza reflecting on his time leading the USDA

Almanza has been hired by U.S.-based meat processor JBS to serve as the global head of food safety and quality assurance. The company has more than 300,000 customers in more than 150 countries. “During his long and storied career at FSIS, Al earned the respect and admiration of his peers for his team-based management approach and his willingness to partner with both industry and public health organizations to ensure the provision of safe, quality food to consumers,” said JBS Global President of Operations Gilberto Tomazoni in a company press release. “JBS is privileged to have someone of Al’s caliber join our company.”

Recall

Agroson’s Recalls Nearly 2500 Boxes of Maradol Papayas

By Food Safety Tech Staff
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Recall

Agroson’s LLC is taking precautionary measures and has recalled 2483 boxes of Maradol Papaya Cavi Brand over Salmonella concerns. The papayas were grown and packed by Carica de Campeche—and other brands that have bought from this farm tested positive for Salmonella. Although no illnesses have been reported, the company initial the recall after FDA notified it about these other brands testing positive.

The papayas (carton codes 3044, 3045 and 3050) were distributed to wholesalers in New York, New Jersey and Connecticut between July 16 and July 19, and were sold until July 31, 2017.

Freshtex Produce of Alamo, TX also announced a voluntary recall of its “Valery” brand Maradol Papayas grown and packed by Carica de Campeche.

Following one death, Grande Produce recalled its Caribeña brand Maradol papayas more than a week ago.

FoodLogiQ

FoodLogiQ in Top 25 Ag-Tech Startups List by Forbes

FoodLogiQ

FoodLogiQ was recently included in Forbes Magazine’s list, “The 25 Most Innovative Ag-Tech Startups”.

“The average food recall costs companies $10 million. FoodLogiQ aims to reduce those costs by using data to track a supply chain (i.e, food) from the farm to the fork, ensuring the correct foods are recalled.” – Forbes

The publication’s process of finding the 25 ag-tech startups with the most potential involved surveying experts, venture capitalists and accelerators, and looking at company financials and agricultural credentials.

“This distinction reflects the dedication of our team and our customers who we routinely collaborate with to develop the best technology to connect the world’s food chain,” said FoodLogiQ CEO Dean Wiltse in a company press release.

FSMA

Company Resources Critical to FSMA Implementation

By Maria Fontanazza
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FSMA

In Part II of Food Safety Tech’s Q&A with Kathy Wybourn, Director Food & Beverage, USA & Canada at DNV-GL, we discuss FSMA preparedness and alignments of the regulation with GFSI.

Food Safety Tech: Now that we’re in the compliance phase, how prepared are food companies to meet FSMA requirements?

Read Part I: Embracing Big Data as an Asset to Your CompanyKathy Wybourn: It depends. Food companies must want to stay informed and make the necessary changes. What is critical in this change is the resources and organization, and not the size of a company. We still see large companies that are not ready for FSMA, same as with smaller companies. It comes down to what they have done proactively to keep up with the regulations, understanding the preventive pieces of that and the shift within their organization.

There are two pieces: It’s about being informed, plus the company’s culture for change. It comes down to management commitment. If you don’t have the management commitment to move an organization to being compliant with FSMA, you can be informed, but the culture isn’t there to support it.

FST: GFSI recently released Version 7.1 to incorporate more harmonization with FSMA. Any thoughts on this new version?

Wybourn: I was in the Technical Work Group for Version 7 guidance document. Adding in the food fraud and food defense components, and the new 7.1 Version brings the GFSI benchmark document closer to FSMA around suppliers and the use of non-approved suppliers.

It puts more requirements on the food manufacturer if they have supplier problems. For example, if there’s an interruption in the supply of a critical ingredient and you don’t have another supplier that’s going through the preventive hazard. It’s very important to know how to follow the requirements around non-approved suppliers. It all fits with the bigger picture of supply chain risks and transferring risks from a supplier (those things you don’t know about), understanding your suppliers and having a contingency plan. And if you don’t have that formal approval through your system, what are the requirements around using a non-approved supplier.

FST: How can the BRC FSMA Readiness Module help food companies with the Preventive Controls rule?

Wybourn: If you’re a BRC-certified site, it gives you guidance on what is needed to be FSMA ready. BRC benchmarked and identified what was missing in the standard and created a module that minimizes the gap. It gives you guidance and reference to the actual CFR and explains what’s needed.

Papaya recall, Salmonella

One Death, Grande Produce Issues Voluntary Recall of Caribeña Papayas

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Papaya recall, Salmonella
Papaya recall, Salmonella
Grande Produce has recalled papayas with the brand name Caribeña labeled on cartons.

One person has died (New York City), 12 people have been hospitalized and a total of 47 people have been infected with a strain of Salmonella Kiambu, according to the CDC. Epidemiological and lab evidence points to yellow Maradol papayas as the “likely” culprit of this multistate outbreak.

Thus far, one brand has been linked to the outbreak, Grande Produce, which has recalled its Caribeña brand Maradol papayas distributed between July 10 and July 19, 2017. The CDC will announce other brands once more information is available. During its investigation, an illness cluster was identified in Maryland.

Grande Produce, a distribution center located in Maryland, has stopped importing papayas from its grower and “is taking all precautionary measures to ensure the safety of its imported produce”, according to a company announcement on FDA’s website. According to Grande Produce, environmental microbial testing of its facilities has, to date, tested negative for Salmonella. “Specific sources of what health officials now believe may be two separate Salmonella outbreaks have not yet been determined,” the announcement states.