Tag Archives: Fda

FDA Frank: Digital prompts key to changing food safety behavior

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Tom Karst of The Packer writes that teasing the details of a new era of smarter food safety, Food and Drug Administration deputy commissioner for food policy and response Frank Yiannas spoke Sept. 18 at the United Fresh Washington Conference.

Before coming to FDA last December, Yiannas was vice president of food safety at Walmart from 2008 to 2018.

And Disney in Orlando before that.

Yiannas said the FDA’s work on produce safety has been front and central to his work since he joined the agency.

He praised the industry for its contribution to food safety and said the public-private partnership on food safety efforts must strengthen even more in what he called a new era of smarter food safety that is set to begin in 2020.

“I was asked by the Commissioner to continue to lead our efforts on modernization,” Yiannas said. “We’ve come a long way since 2011, but there’s still work to be done.”

Tech-enabled traceability and tech-enabled outbreak response will be one area of focus for the new era of smarter food safety, Yiannas said.

While produce has an impressive safety record overall, he said there are weak points in the supply chain.

“What I have learned over the years, and especially from my vantage point with the world’s largest company, is that I do believe the food system’s Achilles heel is traceability and transparency,” he said.

He noted that in both the spinach-related foodborne illness outbreak in 2006 and the romaine-related outbreak in 2018, traceability was an issue.

“It seems eerily similar almost a decade later,” he said. “And we still are having to do these overly broad consumer advisories.”

Distributed ledger or blockchain technology can be part of the solution, he said, but that isn’t the focus.

“It is not about the technology— it is about solving some of our many public health challenges,” he said.

Helping efforts to create a culture of food safety among growers, food marketers, and consumers is another element of the new era plan, he said.

“What I’ve learned over the years, is that it’s impossible to make progress without changing and influencing behavior,” he said, noting the importance of “digital prompts” to encourage right behavior.

I agree.

Ripple: Arizona scientists to examine food safety practices after E. coli outbreak

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In the spring of 2018, an E. coli O157 outbreak linked to romaine lettuce grown in the Yuma, Arizona area resulted in 210 reported illnesses from 36 states, 96 hospitalizations, 27 cases of hemolytic uremic syndrome (HUS) and five deaths.

The U.S. Food and Drug Administration has launched a new initiative with support from the Arizona Department of Agriculture, and in conjunction with the University of Arizona Cooperative Extension, the Wellton-Mohawk Irrigation and Drainage District (WMIDD), and members of the Yuma area leafy greens industry to better understand the ecology of human pathogens in the environment in the Yuma agricultural region. This initiative will be a multi-year study which will focus on how these pathogens survive, move and possibly contaminate produce prior to harvest. 

While the FDA, the Arizona Department of Agriculture and other state partners conducted an environmental assessment from June through August 2018 that narrowed the scope of the outbreak, the specific origin, the environmental distribution and the potential reservoirs of the outbreak strain remain unknown.

Between 2009 and 2017, FDA and partners at CDC identified 28 foodborne STEC outbreaks with known or suspected links to leafy greens. Like a lot of fresh produce, leafy greens are often eaten raw without a kill-step, such as cooking, that could eliminate pathogens that may be present.

Sounds like Yuma growers could use a Box of Rain. Or maybe more knowledge of the microbial ripple effect. May death be groovy for you, long-time Grateful Dead collaborator and lyricist Robert Hunter, who passed on Tuesday, aged 78.

500 sick, 2 dead since 2011: FDA focusing on the papaya industry

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Norman Sharpless and Frank Yiannas of the U.S. Food and Drug Administration write that fresh papayas are most often eaten raw, without cooking or processing to eliminate microbial hazards; and therefore, the way they are grown, harvested, packed, held, processed and distributed is crucial to minimizing the risk of contamination with human pathogens.

Since 2011, American consumers have been exposed to eight outbreaks caused by Salmonella serotypes linked to imported, fresh papaya. And, just this June we started an investigation into an outbreak of Salmonella Uganda illnesses tied to the consumption of whole, fresh papaya imported from Mexico. While the 2019 outbreak is ongoing, the first seven outbreaks accounted for almost 500 reported cases of illness, more than 100 hospitalizations, and two deaths.

This trend has to stop. The pattern of recurrent outbreaks we have observed since 2011, including the 2019 illnesses, have involved Salmonella infections traced back to, or are suspected of being associated with, papaya grown in Mexico. The recurring nature of these outbreaks is a clear indication that more must be done within all sectors of the papaya industry to protect its customers and to meet its legal obligations. This includes growers, importers and even retailers that can and must do more.

This is why today we have issued a letter calling on all sectors of the papaya industry to take actions to prevent these outbreaks in the future. We are urging growers, packers, shippers and retailers in the papaya industry to review their operations and make all necessary changes to strengthen public health safeguards.

Our letter calls on the papaya industry to assess the factors that make their crops vulnerable to contamination. If a foodborne pathogen is identified in the crop or growing environment, a root cause analysis should be performed to determine the likely source of contamination. Procedures and practices that minimize that contamination must be implemented.

We are strongly encouraging the papaya industry to examine the use and monitoring of water used to grow, spray (pesticides, fungicides), move, rinse or wax crops to identify and minimize risks from potential hazards. All sectors of the industry should adopt tools and practices needed to enhance traceability since papayas are a perishable commodity, to more rapidly facilitate the tracking of involved product to expedite its removal from commerce, prevent additional consumer exposures, and properly focus any recall actions.

And finally, they should fund and actively engage in food safety research to identify the potential sources and routes of contamination by microbial pathogens and develop data-driven and risk-based preventive controls.

In response to this most recent Salmonella Uganda outbreak, the FDA deployed an inspection team to the packing house and farm that was linked to the contaminated papayas via traceback and epidemiological evidence. The findings of those visits will be made public when their investigation is complete. We have also increased sampling and screening of papayas at the border. In addition, the FDA is actively collaborating with our counterparts in the Mexican government regarding this current outbreak through the agency’s Latin America Office to determine ways to further our collaborative prevention efforts.

The U.S. Federal Food, Drug, and Cosmetic Act prohibits food producers from introducing, or delivering for introduction, into interstate commerce adulterated foods (meaning foods that are potentially harmful to consumers). Additionally, there are new requirements under the FDA Food Safety Modernization Act (FSMA). The Produce Safety Rule under FSMA sets science- and risk-based minimum standards for domestic and foreign farms for the safe growing, harvesting, packing and holding of covered produce, which includes papayas. Another FSMA rule, the Foreign Supplier Verification Program (FSVP) makes importers responsible for verifying that the foods they bring into the U.S., including papayas, have been produced in a manner that meets applicable U.S. safety standards. 

I prefer mangoes.

Good year for Cyclospora bad year for humans: 205 sick linked to Mexican basil in latest outbreak

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The U.S. Centers for Disease Control (CDC), public health and regulatory officials in several states, and the U.S. Food and Drug Administration (FDA) are investigating a multistate outbreak of Cyclospora infections linked to fresh basil from Siga Logistics de RL de CV of Morelos, Mexico.

CDC is advising that consumers do not eat or serve any fresh basil from Siga Logistics de RL de CV of Morelos, Mexico. This investigation is ongoing and the advice will be updated when more information is available.

Consumers who have fresh basil from Siga Logistics de RL de CV of Morelos, Mexico, in their homes should not eat it. Throw the basil away, even if some has been eaten and no one has gotten sick.

Do not eat salads or other dishes that include fresh basil from Siga Logistics de RL de CV of Morelos, Mexico. This includes dishes garnished or prepared with fresh basil from Siga Logistics de RL de CV of Morelos, Mexico, such as salads or fresh pesto.

If you aren’t sure the fresh basil you bought is from Siga Logistics de RL de CV of Morelos, Mexico, you can ask the place of purchase. When in doubt, don’t eat the fresh basil. Throw it out.

Wash and sanitize places where fresh basil was stored: countertops and refrigerator drawers or shelves.

The FDA strongly advises importers, suppliers, and distributors, as well as restaurants, retailers, and other food service providers to not sell, serve or distribute fresh basil imported from Siga Logistics de RL de CV located in Morelos, Mexico. If you are uncertain of the source, do not sell, serve or distribute the fresh imported basil.

Two hundred and five people with laboratory-confirmed Cyclosporainfections and who reported eating fresh basil have been reported from 11 states; exposures occurred at restaurants in 5 states (Florida, Minnesota, New York, Ohio, and Wisconsin).

Illnesses started on dates ranging from June 10, 2019 to July 18, 2019.

Five people have been hospitalized. No deaths attributed to Cyclospora have been reported in this outbreak.

Epidemiologic evidence and early product distribution information indicate that fresh basil from Siga Logistics de RL de CV of Morelos, Mexico is a likely source of this outbreak.

2019 Outbreak of Cyclospora infections linked to fresh basil from Mexico

15.aug.19

CDC

https://www.cdc.gov/parasites/cyclosporiasis/outbreaks/2019/weekly/index.html

Outbreak investigation of Cyclospora illness linked to imported fresh basil, July 2019

16.aug.19

FDA

https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-cyclospora-illnesses-linked-imported-fresh-basil-july-2019

FDA investigating contaminated pig ear treats connected to Salmonella

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One of daughter Sorenne’s chores is to feed our two cats every night, with their special anti-neurotic food.

And every night I say, wash your hands.

Same with Ted the Wonder Dog and treats.

With the recent announcements of the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) investigating contaminated Pig Ear Treats connecting to Salmonella, Pet Supplies Plus is advising consumers it is recalling bulk pig ear product supplied to all locations by several different vendors due to the potential of Salmonella contamination. Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.

Testing by the Michigan Department of Agriculture and Rural Development revealed that aging bulk pig ear product in one of our stores tested positive for Salmonella. We have pulled bulk pig ear product from the shelves at all of our stores and have stopped shipping bulk pig ears from our Distribution Center. We are working with the FDA as they continue their investigation as to what caused the reported Salmonella related illnesses.

Frank talks about sprouts

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Frank didn’t waste any time after leaving Wal-Mart for government.

Good on ya.

But guidance is not enforcement.

My group learned that the hard way 20 years ago.

And they still serve sprouts to immunocompromised people in Australian hospitals despite a ridiculous number of outbreaks.

“Over the past 22 years, the U.S. Food and Drug Administration (FDA) has investigated 50 reported outbreaks of foodborne illness associated with contaminated sprouts. Together, these outbreaks resulted in more than an estimated 2,600 cases of illness. Last year, there were two reported outbreaks associated with sprouts, resulting in more than an estimated 100 illnesses. Studies indicate that contaminated seed is the likely source of most sprout-related outbreaks, as this commodity is inherently more susceptible to these issues because they are grown in warm and humid conditions that are favorable for bacteria like Salmonella, Listeria and E. coli,” said FDA Deputy Commissioner for Food Policy and Response Frank Yiannas.

“The FDA is committed to taking swift action to respond to outbreaks related to sprouts and keep our food supply safe, but we also know that measures to prevent issues from happening in the first place are an important element of protecting consumers. By studying outbreaks related to sprouts over the years, we have been able to recommend changes in the industry to help lower the incidence of sprout-related outbreaks. Today’s new draft guidance is another critical step, like the Sprout Safety Alliance or sprout-specific requirements of the Produce Safety Rule, the agency is taking to prevent illnesses related to sprouts.”

FDA today released a proposed draft guidance, “Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting,” intended to make the sprout seed industry (seed growers, conditioners, packers, holders, suppliers, and distributors) aware of the agency’s serious concerns with the continuing outbreaks of foodborne illness associated with the consumption of raw and lightly-cooked sprouts.

Incorporating aspects of the Codex Code of Hygienic Practice for Fresh Fruits and Vegetables Annex II, Annex for Sprout Production; the International Sprout Growers Association-Institute for Food Safety and Health’s “U.S. Sprout Production Best Practices”; and Good Agricultural Practices, the FDA’s draft guidance issued today provides the agency’s recommendations to firms throughout the production chain of seed for sprouting. It states that if a grower, holder, conditioner, or distributor reasonably believes that its seeds are expected to be used for sprouting, we recommend that the grower, holder, conditioner, or distributor take steps that are reasonably necessary to prevent those seeds from becoming contaminated. We also recommend that firms throughout the supply chain – from seed production and distribution through sprouting – review their current operations related to seeds for sprouting.

During the 60-day comment period for this draft guidance, stakeholders will be able to provide comments on the draft provisions. For more information on this guidance, as well as instructions on how to submit your comments, please visit Draft Guidance for Industry: Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting.

7 sickened with Salmonella linked to Duncan Hines cake mixes

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Flour comes from dried wheat that’s milled and not heat treated (because it messes with the gluten). Because wheat is grown in nature, Salmonella or E. coli or other nasties can be present. As Salmonella dries out it gets hardier and survives for months (or longer).

In 1957, Duncan Hines and his wife, Clara, cut a cake at the Duncan Hines test kitchen in Ithaca, N.Y.

From Dec. 2015 to Sept. 2016, pathogenic E. coli (both O121 and O26 serogroups) sickened 56 people in 22 states linked to raw flour.

In Nov. 2018, the U.S. Food and Drug Administration investigated recalled Duncan Hines Cake Mixes potentially linked to seven Salmonella Agbeni illnesses.

On January 14, 2019, the Centers for Disease Control reported the outbreak appeared to be over. The FDA, CDC, public health and regulatory officials in several states worked together to investigate this multistate outbreak of Salmonella Agbeni infections.

The FDA recommends consumers to not bake with or eat the recalled product. Additionally, consumers should not eat uncooked batter, flour, or cake mix powder.

The FDA advised consumers not to bake with or eat any recalled cake mix. If already purchased, consumers should throw it away or return to the place of purchase for a refund.

Consumers should always practice safe food handling and preparation measures. It is recommended that they wash hands, utensils, and surfaces with hot, soapy water before and after handling food.

FDA offers these tips for safe food handling to keep you and your family healthy:

Do not eat any raw cake mix, batter, or any other raw dough or batter product that is supposed to be cooked or baked.

Wash hands, work surfaces, and utensils thoroughly after contact with flour and raw batter or dough products.

Keep raw foods separate from other foods while preparing them to prevent any contamination that may be present from spreading. Be aware that flour or cake mix may spread easily due to its powdery nature.

Fresh peaches, nectarines and plums recalled in US because of Listeria

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It’s not often that stone fruit – peaches, nectarines and plums are recalled for Listeria.

Jac. Vandenberg, Inc. of Yonkers, New York is doing just that.

The Fresh Peaches, Fresh Nectarines and Fresh Plums were distributed in Alabama, California, Georgia, Illinois, Kentucky, Maine, Massachusetts, Michigan, Mississippi, New Jersey, New York, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, West Virginia and Virginia through small retail establishments and the following select retail stores:

Retail Stores States Product
ALDI Alabama, Georgia, Kentucky, Mississippi, North Carolina, South Carolina, Tennessee, Virginia Nectarines, Peaches, Plums
Costco California Nectarines
Fairway Market New York Nectarines, Peaches
Hannaford Maine Peaches
Market Basket Massachusetts Nectarines, Peaches
Walmart Kentucky, Maryland, New Jersey, New York, Ohio, Pennsylvania, Virginia, West Virginia Nectarines (MD, NJ, NY, PA, VA, WV), Peaches (KY, NJ, NY, OH, PA, WV)

The peaches and nectarines are sold as a bulk retail produce item with PLU sticker (PLU# 4044, 3035, 4378) showing the country of origin of Chile. The peaches, nectarines and plums sold at ALDI are packaged in a 2-pound bag with the brand Rio Duero, EAN# 7804650090281, 7804650090298, 7804650090304. The nectarines sold at Costco are packaged in a 4-pound plastic clamshell with the brand Rio Duero, EAN# 7804650090212.

No illnesses have been reported to date in connection with this problem to date.

The recall was the result of a routine sampling program by the packing house which revealed that the finished products contained the bacteria. The company has ceased the distribution of the product as FDA and the company continue their investigation as to what caused the problem.

It’s explained by shit in irrigation water: Santa Barbara farm first fingered with outbreak strain of E coli O157 in Romaine lettuce that sickened 59 in US, 28 in Canada: Tumble those dice

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Welcome to Washington, D.C., Frank, and government PR.

On Nov. 20, the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention warned the American public of a multi-state outbreak of E. coli O157:H7 linked to romaine lettuce and advised against eating any romaine lettuce on the market at that time.

According to FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner Frank Yiannas, we  have new results to report from this investigation tracing the source of the contamination to at least one specific farm. Based on these and other new findings, we’re updating our recommendations for the romaine lettuce industry and consumers.
Today, we’re announcing that we’ve identified a positive sample result for the outbreak strain in the sediment of a local irrigation reservoir used by a single farm owned and operated by Adam Bros. Farms in Santa Barbara County.

The FDA will be sending investigators back to this farm for further sampling. It’s important to note that although this is an important piece of information, the finding on this farm doesn’t explain all illnesses and our traceback investigation will continue as we narrow down what commonalities this farm may have with other farms that are part of our investigation. While the analysis of the strain found in the people who got ill and the sediment in one of this farm’s water sources is a genetic match, our traceback work suggests that additional romaine lettuce shipped from other farms could also likely be implicated in the outbreak. Therefore, the water from the reservoir on this single farm doesn’t fully explain what the common source of the contamination. We are continuing to investigate what commonalities there could be from multiple farms in the region that could explain this finding in the water, and potentially the ultimate source of the outbreak.

As of Dec. 13, our investigation yielded records from five restaurants in four different states that have identified 11 different distributors, nine different growers, and eight different farms as potential sources of contaminated romaine lettuce. Currently, no single establishment is in common across the investigated supply chains. This indicates that although we have identified a positive sample from one farm to date, the outbreak may not be explained by a single farm, grower, harvester, or distributor.

At the same time, the U.S. Centers for Disease Control updated its warning to advise U.S. consumers to not eat and retailers and restaurants not serve or sell any romaine lettuce harvested from certain counties in the Central Coastal growing regions of northern and central California. If you do not know where the romaine is from, do not eat it.

  • Some romaine lettuce products are now labeled with a harvest location by region. Consumers, restaurants, and retailers should check bags or boxes of romaine lettuce for a label indicating where the lettuce was harvested.
      • Do not buy, serve, sell, or eat romaine lettuce from the following California counties: Monterey, San Benito, and Santa Barbara.
      • If the romaine lettuce is not labeled with a harvest growing region and county, do not buy, serve, sell, or eat it.
      • The Public Health Agency of Canada has identified ill people infected with the same DNA fingerprint of E. coliO157:H7 bacteria in Canada.

Raw is still risky: Say no to raw dough

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My mother used to make and lot of cakes and brownies with her groovy 1960s hand mixer and I always got to lick the beaters.

No more.

And it’s not just the raw eggs, it’s the raw flour.

In June, 2009, an outbreak of shiga-toxin producing E. coli (STEC, primarily O157:H7) in Nestle Toll House cookie dough sickened at least 77 people in 30 American states. Thirty-five people were hospitalized – from cookie dough.

The researchers could not conclusively implicate flour as the E. coli source, but it remains the prime suspect. They pointed out that a single purchase of contaminated flour might have been used to manufacture multiple lots and varieties of dough over a period of time as suggested by the use-by dates on the contaminated product.

The study authors concluded that “foods containing raw flour should be considered as possible vehicles of infection of future outbreaks of STEC.”

So it wasn’t much of a surprise when 63 people fell sick from the outbreak strain of E. coli O121 from Dec. 2015 to Sept. 2016 linked to raw General Mills flour.

There have been about a dozen other flour-related outbreaks. STEC means people – and kids – get quite sick.

Flour is a raw commodity, crops the flour is derived from could be exposed to anything, and testing is so much better than it used to be.

There are some brands of pasteurized flour out there, but people seem to have gotten used to flour as a cheap source of play-dough-like stuff for kids and something to throw at people.

The U.S. Centres for Disease Control says, nope.

This is not a Christmas conspiracy (although I prefer Solstice Season): it’s CDC providing information, like they are supposed to.

People can, and will, do what they want.

As Maggie Fox of NBC reports, “Do not taste or eat any raw dough or batter, whether for cookies, tortillas, pizza, biscuits, pancakes, or crafts made with raw flour, such as homemade play dough or holiday ornaments,” the CDC advises.

“Do not let children play with or eat raw dough, including dough for crafts.”

Handling food, including flour, requires care and hygiene.

“Keep raw foods such as flour or eggs separate from ready-to eat-foods. Because flour is a powder, it can spread easily,” the CDC notes. “Follow label directions to refrigerate products containing raw dough or eggs until they are cooked. Clean up thoroughly after handling flour, eggs, or raw dough.”