FDA investigating contaminated pig ear treats connected to Salmonella

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

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

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

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

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

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.”

The foreign supplier verification rule is foreign to many importers

My friend, Roy Costa from Florida, sent along this piece and I deemed it worthy.

The foreign supplier verification rule is foreign to many importers, October 20, 2018

The Foreign Supplier Verification Rule (FSVP), 21 CFR Part 1, Subpart L, is the part of the Food Safety Modernization Act that regulates the importation of food covered by FDA. While the Act when into effect in 2015, some importers have not yet fully implemented an FSVP program.

An FSVP program is a risk-based system that ensures that foreign suppliers meet the same US rules for food safety as domestic suppliers. This means that importers must verify that FDA’s rules, the Current GMP Hazard Analysis and Risk Based Preventive Controls for Human and Animal Foods, and the Produce Safety rules, have been implemented by suppliers.

Importers bare the responsibility for verification of the safety of foods imported into the US. The Customs filings now include a line item for the “FSVP Importer”. This entry utilizes the Dunn and Bradstreet’s unique facility identifier-the DUNS Number; no food maybe imported without this filing. Whoever is identified as the FSVP Importer must be qualified through education and experience to understand any document submitted for verification, and is subject to unannounced FDA inspection.

The FSVP rule allows third-party audits, microbial, physical and chemical testing and operational records to be used for verification purposes. The key documents an importer must verify are the Food Safety Plan of foreign manufacturers, and the records that show compliance with the Produce Safety rule.

In order to understand these complex verification documents, one must understand the Hazard Analysis and Critical Control Point (HACCP) concept. Education in the Preventive Controls and Produce Safety rules will be necessary for most importers. Without a scientific background, understanding how to successfully apply the five preliminary HACCP steps and the seven HACCP principles is impossible, and the Produce rule requires a deep understanding of Good Agricultural Practices.

Some importers will not be qualified to make decisions about supplier approval, or even understand what is required of them, without training.

An importer must prepare his own FSVP program for each commodity he obtains, based on a risk assessment similar to HACCP. He can only do this if he is a FSVP Qualified Individual, although he can hire or use another Qualified Individual, if he is not so qualified.

The barriers of entry are high. If a supplier does not meet the rules, or if the importer cannot verify the safety of foods, no such foods can be obtained. This could put some importers out of business, and restrict trade in foreign foods.

The impact is huge for the global economy. Currently, imported foods make up an estimated 15 percent of the U.S. food supply, including 50 percent of fresh fruits, 20 percent of fresh vegetables and 80 percent of seafood.

The FSVP rule prohibits anyone with a financial interest in the outcome of verification to have a financial interest in an approval decision. The problems with conflicts of interest in this scheme are readily apparent, since many importers also own the operations of the foreign supplier, and virtually all importers have some kind of monetary incentive for bringing products into the US.

FDA has the authority to inspect the records of the FSVP Importer, and they typically do not notify in advance of a routine inspection. Once in the office, FDA has access to virtually all the records of the importing firm, and will expect that the firm has a Qualified Individual, policies and procedures, records, and a risk-based system to make decisions about supplier approval, with an approved supplier list. Without these vital documents, there will be no way an importer can demonstrate compliance.

At this time, FDA is making inspections to primarily educate the industry, but they will act if they find an importer violating US rules or obtaining unsafe foods.

With such dire consequences possible, one would expect that an importer would seek education in areas of legal compliance, but the industry has not shown overwhelming interest in taking the training needed to understand their responsibilities.

Eventually, the agency will take a focused approach to weeding out the non-compliant importing operations, but the job will be difficult. Policing these complex importer arrangements will not be an easy assignment; it is well known the importers sometimes flaunt the rules that have been in place, and engage in port shopping, ignoring Import Alerts, and outright deception. These new regulations should allow FDA to be more effective in detecting criminal activity, and I expect that penalties will be severe for importers who bring in contaminated foods that cause illness and death to US consumers.

I also expect that product liability will eventually stretch back to the importer in such cases, and that lawsuits will take into consideration the compliance history of the importer when perusing justice for victims of foodborne illness.

I strongly recommend that both foreign suppliers and importers take the Food Safety Preventive Controls Alliance FSVP course, and the other FSPCA relevant courses as needed, Preventive Controls for Human and Animal Foods, and Produce Safety Rules, and learn how to develop a compliant FSVP program.

Contact Environ Health Associates, Course Administration Manager; Katherine Jones 386-316-7266 for course registration.

If you’re not too busy farming read this: Draft Guidance for industry: Standards for the growing, harvesting, packing, and holding of product for human consumption,

The purpose of this draft compliance and implementation guidance document is to help covered farms comply with the requirements of the Produce Safety Rule, which establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of produce.  Entitled “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption,” the rule is part of FDA’s implementation of the FDA Food Safety Modernization Act (FSMA). 

The draft guidance provides a broad range of recommendations on how to meet the requirements for most subparts of the rule. It also outlines how to determine whether produce or farms may be eligible for exemptions from certain requirements, or from the rule in its entirety.  

Specific regulatory or statutory requirements are cited, and in some cases, specified using the word must. The use of the word should indicates that something is recommended, but not required. The use of the word including means options that are not limited to the described items.

You are encouraged to submit comments on the draft guidance within 180 days of the publish date to ensure your comments are considered while FDA works on the final version of the guidance.

In addition to the draft guidance, there is an At-a-Glance overview of key points in each of the nine chapters described below, as well as a glossary of key terms. The overviews summarize important aspects of each chapter.  It is recommended that you review the draft guidance itself for complete information.

Frank Yiannas headed to FDA

Bob Brackett, who was the U.S. Food and Drug Administration’s point man during the E. coli spinach outbreak of 2006 ( and did a great job), told me once it was always part of the plan to work in academia, government and industry, and he’s done it.

Much praise from this critic.

 

Frank Yiannas, the vice president of food safety for Walmart and an outspoken proponent of blockchain, is leaving retail to take a post at the Food and Drug Administration.We visited Frank when he was at Disney, Frank visited us when we were in Kansas, we went shopping together at Walmart, as food safety nerds do.

 

I have a lot of respect for Frank, and hope the bureaucratic screws don’t wear him down.

He always said, where can I get the most bang for my food safety buck (OK, those are my words) but I’m fairly sure Frank would go along with that encapsulation.

And the Susies in our lives.

44 sick from Salmonella Enteritidis linked to shell eggs from Gravel Ridge Farms

Amy and I helped make breakfast for 120 grade 4 and 5 school kids this morning.

The kids had their annual sleepover Friday night at the school, in tents, with activities and endless gossip until late night or early morning (that’s Hubbell being busy in the background).

We arrived about 5:50 a.m., ready to make breakfast.

The menu was bacon and egg sandwiches on rolls, brown beans, and juice, along with vegan and halal alternatives, reflecting the multi-cultural nature of our neighbourhood and Sorenne’s school.

Amy worked in the kitchen, prepping rolls and keeping things rolling, while me and another dude worked the grill.

We cooked the bacon we had, then cleaned the grill thoroughly out of respect for others, and then the eggs.

There were no runny eggs.

There was no cross-contamination.

There wasn’t going to be some sorta Salmonella outbreak on my watch.

And Australia still has an egg problem.

What you do at home is your own business, but when cooking for 120 children, risk management is a little different.

For example, the U.S. Food and Drug Administration, along with the Centers for Disease Control and Prevention (CDC) and state and local partners, investigated a multi-state outbreak of Salmonella Enteritidis illnesses linked to shell eggs.

As of October 25, 2018, there were 44 illnesses associated with shell eggs from Gravel Ridge Farms, in Cullman Alabama. The CDC has announced that this outbreak appears to be over.

The FDA advises consumers not to eat recalled shell eggs produced by Gravel Ridge Farms. Consumers who have purchased these products should discard the eggs or return them to the store for a refund. For a complete list of stores, visit the recall notice.

Consumers should always practice safe food handling and preparation measures. Wash hands, utensils, and surfaces with hot, soapy water before and after handling raw eggs and raw egg-containing foods. Dishes containing eggs should be cooked to 160° F. For recipes that call for eggs that are raw or undercooked when the dish is use either eggs that have been treated to destroy Salmonella, by pasteurization or another approved method, or pasteurized egg products.

On September 5, 2018, the FDA and Alabama Department of Agriculture and Industry began an inspection at Gravel Ridge Farms and collected environmental and egg samples for laboratory testing. The results were used to confirm that Salmonella Enteritidis isolates collected from environmental and egg samples taken at the farm were genetically related to isolates obtained from ill persons.

As a result of the outbreak, Gravel Ridge Farms voluntarily recalled cage-free, large eggs and removed the eggs from the shelves at grocery stores, restaurants, and other retail locations.

Twenty-six of 32 (81%) people interviewed reported eating restaurant dishes made with eggs. These restaurants reported using shell eggs in the dishes eaten by ill people.

The whole restaurant dishes-made-with-raw-eggs-thing, such as mayo and aioli is problematic. My 9-year-old knows to ask how the aioli is made if she gets fish, and the server always comes back and says, chef makes it only with raw eggs, and she knows enough to say no.

But we are the poop family (it’s on the front door).

I had a couple of thermometers in my back pack but were not necessary.