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Updated: 1 hour 21 min ago

Land-grant universities boost food safety for freshcut produce

Sat, 12/16/2017 - 00:00

Editor’s note: This information is from agisamerica.org, a website supporting the work of the Association of Public & Land-Grant Universities.

Food safety and quality control are huge issues in grocery stores when it comes to products like packaged salad, carrot sticks, and pre-sliced fruit.

Ready-to-eat foods from retailers can spoil easily and have been responsible for foodborne illness outbreaks, which cost billions of dollars due to recalled products, healthcare expenses, lost wages and worker productivity.

To address such problems, the U.S. Department of Agriculture has partnered with 14 land-grant universities and international institutions. Research projects have already lead to improvements.

Achievement and continuing work includes:

  • Scientists have been able to determine the optimal ripeness for cutting and processing fresh produce so it lasts longer. They’ve also designed biodegradable packaging made from renewable resources that can control humidity and release antimicrobials. These innovations have dramatically changed the quality of these foods.
  • Scientists have experimented with different cleansing techniques, sanitizers, protective coatings, pathogen detectors, and more tools that can find, remove, and kill dangerous bacteria and the biofilms they form.
  • The scientists have produced educational materials and training courses that have allowed federal agencies, industry members, growers, processors, and consumers to accept and adopt these new practices.

For additional information on specific projects at 14 institutions, click on the following links:

The U.S. Congress launched the land-grant university concept in 1862 as a response to a growing demand for agricultural and technical education.

The Morrill Act of 1862 granted federal land to states to establish land-grant universities to focus on the practical teaching of agriculture, science and engineering. In 1890 and 1994, Congress expanded the Morrill Act to create additional land-grant universities in the western and plains states.

In 1914, Congress widened the reach of land-grant universities under the Smith Lever Act, which established Cooperative Extension Services to bring research from land-grant universities to farmers, consumers and families. With Cooperative Extension, land-grant universities are able to offer their resources directly to the public.

Today, there is at least one land-grant university in every state and territory of the United States, including the District of Columbia.

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Consumer and industry representatives meeting with FSIS

Fri, 12/15/2017 - 00:55

The USDA’s top food safety officials are for the first time making public the names of consumer and industry representatives they meet with during separate monthly meetings.

The meetings on Nov. 14 included Carmen Rottenberg, acting deputy Under Secretary for Food Safety, and Paul Kiecker, acting administrator of the Food Safety and Inspection Service.

Disclosure of the expected attendance lists came as an attachment to the just-released FSIS public calendar for November. During former FSIS Administrator Alfred “Al” Almanza’s decade-long tenure, names of individuals attending the consumer and industry meetings were not disclosed.

Both meetings allowed attendees to participate in person at FSIS headquarters in Washington D.C., or via teleconference. The session with consumer representatives was the smaller of the two meetings, with six attending in person and four on the phone.

Here’s who was signed up representing consumers’ interests:

In-person attendance
Thomas Gremillion, Consumer Federation of America
Tony Corbo, Food and Water Watch
Will Wallace, Consumers Union
Jack Barnett, Consumers Union
Jaydee Hanson, Center for Food Safety
Elise Ackley, Pew Charitable Trusts

Teleconference Attendance
Pat Buck, Center for Foodborne Illness Research and Prevention
Deirdre Schlunegger, STOP Foodborne Illness
Felicia Nestor, Food and Water Watch
Tanya Roberts, Center for Foodborne Illness Research and Prevention

Later the same day, the room was more crowded for the industry meeting with 14 people signed up to attend in person and 25 via the teleconference:

In-person Attendance
John Dillard, OFW Law
Betsy Booren, OFW Law
Lia Biondo, Western Skies Strategies
Tiffany Lee, North American Meat Institute
Laurie Bryant, Meat Import Council of America Inc.
Hilary Thesmar, Food Marketing Institute
Bob Hibbert, Lewis & Bockius LLP
Brett Schwemer, OFW Law
Ferd Hoefner, National Sustainable Agriculture Coalition
Juan Pio Hernandez, Allen F. Johnson & Associates
Keith Day, Twin Rivers Foods
Brian Eyink, Hogan Lovells U.S. LLP
Will Crosby, National Turkey Federation
Tori Ahlmeyer, National Turkey Federation

Teleconference Attendance
Ken Mastracchio, North American Meat Institute
Brian Sylvester, Heckman LLP
Jessica Wasserman, Wasserman & Associates
Casey Wooton, Triumph Foods
Kathy Simmons, National Cattlemen’s Beef Association
Charles Link, Cargill
Norm Robertson, North American Meat Institute
Randy Green, United Egg Association
Michael Bradley, Smithfield Foods
Kristin Lindahl, Cargill
Charlotte Waller, Virginia Poultry Growers Co-op
Stacey Grant, Keystone Foods
Bryan Miller, Wayne Farms LLC
Dan Kovich, National Pork Producers Council
Suzanne Finstad, Tyson Foods
Cheyenne McEndaffer, U.S. Meat Export Federation
Lindsay Cammel, U.S. Meat Export Federation
Travis Arp, U.S. Meat Export Federation
Thad Lively, U.S. Meat Export Federation
Paul Clayton, U.S. Meat Export Federation
Katie Hanigan, Smithfield Foods
Lisa Weddig, National Fisheries Institute
Len Lang, USCBIA, AGRO, SAMPCO
Lisa Wallenda Picard, National Turkey Federation
Oscar Garrison, United Egg Producers

Also on the calendar
The FSIS public calendar for November shows Rottenberg had seven other meetings with people outside the federal government. Kiecker did two sessions with outsiders on his own.

Kiecker on Nov. 1 gave a regulatory update to the National Chicken Council’s Board of Directors meeting. The next day, he met with Cargill’s Daniel Etzler about Canadian exports.

Rottenberg and Kiecker jointly met with officials from Mexico’s National Service for Plant and Animal Health (SENASICA) on Nov. 13 for a “Meet and Greet.”

On Nov. 14, the two interim leaders met with Brad Respess and Terry Bruce Sr., from Tip Top Poultry about “export concerns.” They also huddled with Johnsonville Sausage representatives about “Salmonella and establishment operations.”

Rottenberg met with congressional staff about Netherlands egg products and with Randy Russell of the Russell Group about Codex issues, both on Nov. 16.

Michael Gilsdorf from the National Association of Federal Veterinarians met with Rottenberg and Kiecker on Nov. 20 about recruitment and retention of the FSIS veterinary workforce.

Finally, Rottenberg discussed Brazil with Agri-Pulse reporter Bill Tomson on Nov. 21.

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Briefly: Whoa, chicken — Summit discounts — Bakers fined

Fri, 12/15/2017 - 00:37

Every hour of every day people around the world are living with and working to resolve food safety issues. Here is a sampling of current headlines for your consumption, brought to you today with the support of Alchemy Systems.

Food Safety Summit discount deadline
Focusing on the importance of food safety through the entire supply chain, the 20th annual Food Safety Summit is scheduled for May 7-10 in Rosemont, IL, at the Donald Stephens Convention Center.

“It is vital to understand not only your roles and responsibilities but also those in the rest of the process,” summit organizers said when they announced the agenda for the 2018 event.

A wide range of the food community’s needs and situations will be explored through case studies, educational sessions, peer-to-peer discussions, and demonstrations of new technologies.

View the “Schedule-at-a-Glance” for the Food Safety Summit’s agenda. Early registration discounts are still available, but only through Dec. 31. The code “20for20” can be used for 20 percent discounts until the Dec. 31 early registration deadline. Discounted student pricing and group discount pricing are also available.

Australian bakery fined after 200 fall ill
The two owners of the Box Village Bakeryin New South Wales, Australia, each pleaded guilty to five breaches of selling unsafe food, and five breaches of failing to meet food safety standards and were fined $61,000 each for their roles in an outbreak that sickened more than 200.

The Australian bakery owners’ shop was found to be the source of a Salmonella outbreak in January 2016. The bakery in south Sydney closed after customers complaints of Salmonella began.

Customers who became ill reported having eaten chicken rolls, salads and other items from the bakery.

According to Dr. Lisa Szabo, CEO of the NSW Food Authority, the fines served as a reminder to all food businesses and individuals as to why food safety systems are crucial.

CSPI condemns faster poultry line speeds
Production line speed limits for the processing of slaughtered chickens are up for review and consumer watchdog groups say demands by the National Chicken Council are dangerous.

Having no limit on line speeds could compromise food safety, according to the Center for Science in the Public Interest. The CSPI urged the U.S. Department of Agriculture to reject a poultry industry lobbying group’s petition, submitting comments in opposition to the faster line speeds.

Currently, the pace of chicken slaughterhouse lines are allowed to move at 140 birds per minute, which is “a speed set to allow federal inspectors adequate time to assess chicken carcasses for fecal contamination and other problems under traditional inspection procedures,” according to CSPI.

If the USDA grants the request to implement a waiver system that would allow operation of indefinite, or “any line speed at which they can maintain process control,” then a single federal inspector could be asked to observe more than 200 chicken carcasses per minute, meaning three carcasses per second. No USDA program has ever tested speeds like this.

“We question whether a third of a second is adequate time for an inspector to see much of anything, let alone evidence of fecal contamination on a chicken carcass,” according to Sarah Sorscher, CSPI deputy of regulatory affairs. “The faster line speeds have the potential to increase fatigue and injury on the part of workers and raise the probability of a human error that compromises food safety.”

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One dead; E. coli outbreak linked to romaine lettuce spreading

Fri, 12/15/2017 - 00:16

One person is dead, two more provinces are reporting illnesses and nine more people are confirmed sick, but no one has recalled any products, named any brands, or identified any retailers who sold fresh romaine lettuce that is implicated in an E. coli outbreak in Canada.

The Public Health Agency of Canada reported the death and additional victims late Thursday. The agency first acknowledged the E. coli O157:H7 outbreak Monday, reporting 21 people confirmed sick across three provinces, Quebec, New Brunswick and Labrador and Newfoundland.

Canadian health officials added Ontario and Nova Scotia to the outbreak map Thursday when they increased the confirmed victim count to 30. The outbreak update did not indicate what province had recorded the death.

The most recent person became sick on Dec. 2, suggesting the implicated romaine lettuce could still be in the stream of commerce. Canadian officials have not reported whether the romaine lettuce identified by victims was whole head, leaves, hearts or chopped.

“Many individuals who became sick reported eating romaine lettuce before their illnesses occurred,” according to the outbreak from the federal health agency. “The Canadian Food Inspection Agency (CFIA) is working with public health officials to determine the source of the romaine lettuce that ill individuals were exposed to.

“At this time, there are no product recalls associated with this outbreak. The outbreak investigation is ongoing, and this public health notice will be updated on a regular basis as the investigation evolves.”

It is likely additional victims will be identified because it can take up to 10 days after exposure for symptoms to develop. Then, it can take several weeks from the time a person becomes ill to when the illness is reported and testing confirms a link to the outbreak, according to the public health agency.

Of the 19 people for whom specific information is available, illness onset dates range from Nov. 16 through Dec. 2. A dozen of the victims have had symptoms so severs that they required hospitalization. The age range of the victims is 4 to 80 years old.

The public health agency notice does not indicate when federal officials became aware of the outbreak or why it was not revealed to the public until Dec. 11.

Advice to consumers
Although anyone can contract an E. coli infection, pregnant women, people with weakened immune systems, young children and older adults are most at risk for developing fatal infections or severe complications.

Anyone who has eaten romaine lettuce and developed symptoms of E. coli infection should immediately seek medical attention. Specific lab test are required to diagnose E. coli infection.

Symptoms can include nausea, vomiting, headache, mild fever, severe stomach cramps, and watery or bloody diarrhea. The onset of symptoms can range from 1 to 10 days after exposure.

“Some do not get sick at all, though they can still spread the infection to others. Others may feel as though they have a bad case of upset stomach. In some cases, individuals become seriously ill and must be hospitalized,” according to the health agency notice.

People who develop hemolytic uremic syndrome (HUS) need intensive medical treatment, usually including dialysis for kidney failure.

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Dairy recalls raw milk for E. coli; best-by dates through Dec. 23

Thu, 12/14/2017 - 15:59

Anyone who has whole, raw milk on hand from Old Silvana Creamery should not consume it, according to the dairy owner, because samples of it have tested positive for E. coli, which can cause serious and sometimes fatal illnesses.

Jim Sinnema, owner, issued the recall today for the milk, which has best-by dates between Dec. 15 and Dec. 23. The dairy has voluntarily and temporarily ceased sales, according to state officials.

“The recall includes both of the firm’s retail raw milk brands, ‘Jim’s Jerseys’ and ‘Guernsey Goodness,’ which were bottled in half-gallon and one-gallon plastic jugs with orange or green caps. Recalled product was sold at the on-farm store, directly to private customers, and at retail stores in Western Washington,” according to the recall notice.

“Consumers who have purchased Old Silvana Creamery retail raw milk with ‘Best By dates’ of  12/15 through 12/23 are urged not to drink the product and return it to the place of purchase for a full refund. Consumers with questions may contact the company at 425-268-7961.”

Anyone who has consumed any of the recalled milk and developed symptoms of E. coli infection should immediately seek medical attention and tell their doctors about the possible exposure. Specific tests are required to diagnose E. coli infections. No illnesses had been reported as of today, according to a spokesman with the Washington State Department of Agriculture (WSDA).

However, it can take up to 10 days for symptoms of E. coli infection to develop. Consequently, anyone who has consumed the recalled raw milk or served it to their children or others should watch for symptoms in the coming days.

Symptoms often begin slowly with mild belly pain or non-bloody diarrhea that worsens over several days, according to the Centers for Disease Control and Prevention. Other symptoms can include severe stomach cramps, bloody diarrhea, and vomiting. If there is fever, it usually is not very high, less than 101 degrees F.

A life-threatening complication — hemolytic uremic syndrome (HUS) — impacting the kidneys can occur, especially in children. It develops an average of seven days after the first symptoms appear, often when the diarrhea is improving.

This is at least the third time Old Silvana Creamery has recalled its raw milk because of contamination issues. In January 2015 the dairy recalled unpasteurized milk when Campylobacter bacteria were detected. In 2013 the dairy recalled raw milk because of antibiotic residues, according to records at WSDA.

“Old Silvana Creamery LLC and WSDA continue to work jointly to address the source of the problem while conducting additional product testing through the WSDA laboratory as well as Old Silvana Creamery’s independent laboratory,” according to the dairy’s recall notice.

It is within the law to sell unpasteurized milk and other dairy products at retail locations, according to Washington state law, but state health officials caution that it carries significant risks, especially for young children, the elderly, pregnant and nursing women and anyone with a suppressed immune system, such as cancer patients.

State law requires unpasteurized, raw milk and raw dairy products to carry warning labels.

“The potential health risks are serious,” according to state officials. “Consumers should read the warning label on the retail raw milk container carefully and ask their retailer to verify the milk was produced and processed by a WSDA-licensed operation.”

There are currently only 32 licensed raw milk operators in the state.

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Springfield Smoked Fish recalls salmon after Listeria detected

Thu, 12/14/2017 - 00:03

A Massachusetts company has suspended operations and is recalling some of its pre-sliced smoked salmon because federal inspectors confirmed Listeria monocytogenes in a sample of the product.

Springfield Smoked Fish of Springfield, MA, distributed an undisclosed amount of the implicated “Nova Salmon” to retailers in Rhode Island and Connecticut, according to the recall notice posted Wednesday on the Food and Drug Administration’s website.

Consumers are urged to check their homes for the recalled smoked salmon and either discard it or return it to the place of purchase. Any surfaces, such as countertops, dishes or utensils used to prepare or serve the recalled fish should be throughly washed and disinfected.

To identify the recalled fish, which is packaged in clear plastic, consumers should look for the following label information: lot number 42173 on the back of the package, an expiration date of Dec. 22, 2017, and a UPC number of 811907018018.

Anyone who has eaten any of the recalled fish and developed symptoms of Listeria infection should seek medical attention and tell their doctors about their possible exposure to the pathogen. Also, people who have eaten the recalled fish and not become ill should monitor themselves in the coming weeks because it can take up to 70 days for symptoms to develop.

“No illnesses have been reported to date in connection with this problem,” according to the recall notice. “This issue was identified after FDA product sampling identified Listeria monocytogenes in the product. The production of the product has been suspended while FDA and the company continue to investigate the source of the problem.”

Listeria monocytogenes is a microscopic organism that can cause serious infections in young children, frail or elderly people, and others with weakened immune systems, sometimes causing death. Symptoms include high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea.

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FDA blocks tuna from Vietnamese company for hepatitis A

Thu, 12/14/2017 - 00:02

The expansion Wednesday of an Import Alert means the automatic detention at the U.S. border of fresh and frozen raw tuna from a Vietnamese seafood company because of hepatitis A contamination.

Sustainable Seafood Co. Ltd. of Cam Lam, Vietnam, is the second Asian company to make the Import Alert list for fresh and frozen raw tuna because of hepatitis A contamination. Two weeks ago, on Dec. 1, the Food and Drug Administration added fresh and frozen tuna from Indonesia’s P.T. Deho Canning Co. to the same Import Alert.

The Import Alert for fresh and frozen raw seafood for hepatitis A concerns stems from FDA testing and follow-up screening dating back to May this year.

“Hepatitis A virus is excreted in feces of infected people and can produce clinical disease when susceptible individuals consume contaminated water or foods, ” the FDA Import Alert says.

Hepatitis A transmission is mostly through person-to-person contact through fecal contamination, but common-source epidemics from contaminated food and beverages also occur.

“Poor sanitation and crowding facilitate transmission. Contamination of foods by infected workers in food production facilities/processing plants and restaurants is common. No known non-human sources of the virus exist,” according to FDA.

The agency says the hepatitis A virus contamination of the seafood is a result of unsanitary conditions in the production or packing facilities, such as reduced worker hygiene, inadequate worker sanitation facilities, and contaminated water supplies.

Import Alerts signal the world about which products or companies are experiencing food safety problems. The term FDA uses when ordering an automatic detention is “Detention Without Physical Examination” or DWPE.

If an importer does not do anything about to resolve the issues, products subjected to automatic detention at U.S. borders and ports of entry will be sent back or destroyed. FDA can also ask customs officials to seize detained products.

For FDA to consider removing a firm and product from detention without physical examination status, the agency must have evidence establishing the conditions that gave rise to the apparent violation are resolved and that FDA can have confidence that future entries will comply with the U.S. law.

“Therefore, it is expected the firm and an agent thereof will submit information outlining the firm’s investigation into the cause of the violation as well as any follow-up steps are taken to prevent violations in future shipments,” says raw tuna alert says.

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Lab robots crucial for end-to-end food safety data systems

Thu, 12/14/2017 - 00:00

Next generation sequencing is beginning to replace traditional DNA methods in food safety testing. As this trend continues, sequencing will no longer be the time intensive process it once was. Laboratories will be limited by how quickly they can prepare samples, not how quickly they can sequence them. Automation will, therefore, play an increasingly critical role in the evolution of laboratory processes.

Critical stages of the NGS (next generation sequencing) workflow are already being automated by a variety of hardware and software innovations. Robotic solutions, for example, play an important role in addressing the substantial bottlenecks created by humans preparing lab samples.

In the next two to three years, automation of a different kind will help us to fully leverage the precision and speed of NGS technologies. The effective automation of bioinformatic workflows will dramatically increase our ability to analyze enormous bodies of data and identify macro-level trends across large volumes of data.

By leveraging NGS technologies and the technologies that automate NGS workflows — from library preparation to sequencing, analysis, and interpretation — the food industry at large will finally have the kinds of tools and information it needs to proactively identify threats and prevent outbreaks from occurring.

Sequencing secrets
Next generation sequencing is on its own an automated DNA sequencing technology. The technology has revolutionized the study of genomics and is quickly making inroads in food safety applications. NGS has distinct advantages over traditional sampling methods like Polymerase Chain Reaction (PCR) or antigen-based methods.

First, NGS generates and analyzes millions of sequences per run, allowing researchers to sequence, re-sequence and compare data at a rate previously not possible. Second, NGS testing is universal, while PCR testing methods are targeted. With PCR you have to know what you expect to find in order to test for it. What’s more, each target requires a separate testing run. This is costly and doesn’t scale.

By contrast, a single NGS test exposes the precise ingredients and all potential threats — both expected — in any given sample. In the not too distant future, the cost and speed of NGS will meet and then surpass legacy technologies.

Adopting NGS technologies, however, doesn’t necessarily mean you’ve solved a number of bottlenecks in workflow. Robotics is playing a key role in automating critical stages of the NGS workflow.

Challenges to food analysis automation
Preparing sample materials for food testing workflows requires a coordinated series of molecular biology reactions. Library prep can take up to 60 percent of a lab technician’s time and directly impacts the quality of resulting analyses. This process, known as sample preparation or library preparation, can be performed manually or automatically and can vary according to application and throughput.

In clinical and pharmaceutical settings, for example, robotic systems automate numerous operations, including liquid handling, creating efficiencies and helping to generate the highest quality data possible.

Adopting existing robotics systems for food testing is not as straightforward as it might seem, though. In doing so, the food testing industry has had to overcome unique challenges. In contrast to the materials being analyzed in clinical and pharmaceutical settings, food comes in a wide variety of forms: environmental samples, packaged foods, dairy, meat, and produce in solid, liquid, powdered, frozen, cooked, raw and concentrated forms. All of these require different methods of preparation before they can be analyzed.

Another challenge inherent to food analysis is that the compounds in natural products are variably distributed throughout unprepared samples. Complex food items further complicate this issue, as dozens of ingredients can be heterogeneously distributed throughout any given product.

Cryogenic mills or grinders blend samples at low temperatures and are often used to prepare samples of fruits and vegetables being analyzed for volatile pesticides. These mills and grinders produce homogenous samples of small sizes that can be held in a relatively small volumes of solution. This is important because it increases the efficiency of liquid-handling applications, those most commonly automated in today’s food testing labs.

Robotic liquid handling
Having long been deployed in clinical settings, robotic liquid handlers are a mature and reliable technology. The same handler a food lab has used to prepare samples for PCR can be deployed to prepare samples for NGS.

Robotic liquid handlers are XYZ robotic systems that dispense selected quantities of samples, reagent, or other solutions into the appropriate containers for any given application. Some examples on the market include: BioRad’s iQ-Check Prep System, a robotics platform that performs DNA extraction and PCR plate set-up, as well as Illumina’s automated solutions that are specific to NGS sample prep.

Food safety’s next frontier
Beyond robotics, another target for automation in the near term time is in artificial intelligence and machine learning to amplify our existing bioinformatic workflows. NGS provides an enormous amount of data, much of which goes unused in food safety applications today. The next revolution in food safety is in automating data-science operations that can leverage this data.

Automating bioinformatic workflows will dramatically increase our ability to analyze enormous bodies of data and identify macro-level trends. Imagine the insights we could gain when we combine trillions of genomic data points from each phase in the food safety testing process — from routine pathogen testing to environmental monitoring to serotyping.

The first step is to unify all of the various tests performed at each stage of the food safety workflow into a single, universal test. Just having the all this data in a single place represents enormous opportunity.

We could begin to query the data for questions you’d typically ask of your food safety systems:

  • What is the risk profile of a given sample?
  • Does it contain harmful pathogens?
  • What strains are present?
  • Are the pathogens from a supplier or the environment in which it was manufactured?

A single algorithm could reveal such information in a single test run.

This is just the first layer of automation — which on its own we expect to drive down the costs of testing, increase scale, and reduce errors that emerge in today’s data silos.

Where it gets interesting is when you add in a secondary layer of automation in the form of machine learning and artificial intelligence. That’s how our industry will truly get our data to work harder for us. Imagine what’s possible when we can automate insights that are impossible to identify today without a team of bioinformaticians working with reams of data over long periods of time?

With the addition of machine learning, we can conduct analyses across bioinformatics runs. We can associate genomic data with data gathered across the supply chain. This will dramatically enhance our ability to identify emerging pathogen threats, locate problematic suppliers, build rapid response consumer-alert systems, model for long-term threats of climate change, and even draw conclusions about consumer preferences.

What’s next?
The holy grail of food safety is to have end-to-end systems in place for gathering supply chain and sequencing data, which can then be appended to and stored on immutable decentralized block chains.

We’re not too far off from that. Recent advances in IoT are making it easier than ever before to gather data at each stage of the supply chain, from farm to table.

Block chain technology is already being tested for food industry use cases in large pilots with top global brands. We’re even starting to see the first miniaturized sequencers becoming commercially available, which is the first step toward in-line sequencing.

The essential technological components exist. In order to build the end-to-end system of the food safety future, we will have to fuse these components and

their operation together. That is an enormous technological, infrastructural, and cultural challenge. I’m confident we’ll get there. The opportunities are too great to imagine otherwise.

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Dog food recalled for Salmonella; pet owners also at risk

Wed, 12/13/2017 - 14:17

Darwin’s Natural Pet Products has recalled specific production lots of its Natural Selections brand Meals for Dogs after laboratory testing detected Salmonella in samples of the products.

People who have handled the dog food are at risk of Salmonella infection and are advised to seek medical attention immediately if they develop symptoms of salmonellosis. Symptoms can include nausea, vomiting, abdominal cramps, diarrhea that is watery or bloody, fever and headache.

Countertops, utensils and pet food and water bowls should be throughly washed to prevent cross-contamination.

According to a Darwin customer service representative, the following four production lots have been recalled:

  • Natural Selections Turkey Meals for Dogs, net wt. 2 lb. Lot #39937 (manufactured 08/24/17)
  • Natural Selections Turkey Meals for Dogs, net wt. 2 lb. Lot #40507.
  • Natural Selections Duck Meals for Dogs, net wt. 2 lb. Lot #40487 (manufactured 09/29/17)
  • Natural Selections Chicken Meals for Dogs, net wt. 2 lb. Lot #40727

Darwin sells and ships its products directly to customers. The product is not available in stores, nor is it sold to distributors, according to the company. The recalled products were shipped to customers in September and early October.

Customers who were supplied with the affected products were notified of the recalls by email, with telephone follow-up where necessary, according to the company. No public recall notice was issued, although some information regarding the recall has been posted on Darwin’s Facebook page.

According to information posted on Darwin’s Facebook page, the company does not test “each and every batch of product” at present, but is re-evaluating its current processes in light of the current situation.

The Food and Drug Administration is aware of the recall, according to an agency spokesperson. No further information was available from FDA.

Between October 2010 and July 2012, FDA surveyed more than 1,000 samples of pet foods and pet treats for the presence of food-borne disease bacteria, including Salmonella. Of the 196 samples of raw pet food tested during the study, 15 were positive for Salmonella.

On July 16, 2013, FDA issued a “Compliance Policy Guide for Salmonella in Food for Animals,” affirming a zero-tolerance policy for Salmonella in pet food due to the risk to human health.

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Pork salami recalled after customer finds metal shavings

Wed, 12/13/2017 - 00:03

A customer complaint about metal shavings in pork salami has led to a small recall — just 143 pounds — by Santa Fe Importers Inc. of Long Beach, CA. The recall was issued Tuesday.

According to the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS), the recalled pork salami products were produced on Aug. 3. Products subject to the recall are:

  • 3.5 to 4.0-lbs. (random weight)  of plastic-wrapped packages of “MARISA PREMIUM QUALITY GENOA SALAMI ITALIAN BRAND,” with a packaging date of Sept. 14, 2017, with a  lot of code of 257-100161 in the upper right-hand corner.

The recalled products bear establishment number “EST. 4118” inside the USDA mark of inspection on the label. The pork salami was shipped to retail locations in California. FSIS was notified by a Santa Fe customer about the metal shavings problem on Monday.

There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.

FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers.

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Briefly: Baby milk not in U.S. — Salmonella up — Steam heat

Wed, 12/13/2017 - 00:02

Every hour of every day people around the world are living with and working to resolve food safety issues. Here is a sampling of current headlines for your consumption, brought to you today with the support of Alchemy Systems.

EU salmonella rates on the rise
Over the past three years the European Union has experienced a 3 percent increase in salmonella food poisoning cases; a “worrying reversal of a decade-long declining trend,” according to a recent report.

In 2016, Salmonella bacteria caused 94,530 human cases of salmonellosis in the EU. Of those, a total of 1,766 people were hospitalized, and 10 people died.

Mike Catchpole, chief scientist of the European Centre for Disease Prevention and Control, said that the increase shown by their surveillance data “is worrying and a reminder that we have to stay vigilant.”

“Salmonella was the most commonly detected causative agent – with one out of six outbreaks due to S. Enteritidis – followed by other bacteria, bacterial toxins and viruses. Salmonella in eggs continued to represent the highest risk agent/food combination,” according to the report.

Massive baby milk recall; 26 infants sick  
Lactalis, a French baby milk producer, is recalling certain batches of baby milk for Salmonella. The recall came after 26 infants became sick with Salmonella Agona, known to cause diarrhea and fever that is particularly dangerous for babies.

“Despite the fact that all the batches exported were conformed to the local rules, Lactalis has decided to remove batches produced since the 15th of February 2017,” according to the recall notice.

The recalled products were not distributed in the United States, though Lactalis does have a robust U.S. operating unit. Countries known to have received the recalled products include: Britain, Greece, Morocco, Sudan, Peru, Colombia, Pakistan, Bangladesh and China. Click here for the full list of recalled products, which includes brand names such as Milumel, Celia, and Picot.

One of the largest dairy groups in the world, Lactalis recommended “not to consume these batches or, in case of absence of alternative, to boil the recombined milk during 2 minutes and bring back it at the consumption temperature.”

Superheated steam could boost melon safety 
New research on the effectiveness of superheated steam (SHS) on watermelon and cantaloupe shows a 10- to 30-second blast can greatly reduce foodborne pathogens on their surfaces.

The specific pathogens involved in this study were E. coli, Salmonella and Listeria monocytogenes. Cantaloupe’s so-called netted rind provides the perfect hiding place for pathogens, which are difficult to wash off and easy to drag into the flesh of the fruit during cutting.

In 2011 a multistate outbreak of Listeria monocytogenes infections was linked to whole cantaloupes from Jensen Farms in Colorado. Out of the 147 ill people confirmed infected, 33 died and one pregnant woman miscarried. Additionally, 99 percent of the victims required hospitalization.

“The results of this study suggest that SHS treatment can be used as an antimicrobial intervention for cantaloupes and watermelons without inducing quality deterioration,” according to the research abstract.

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Letter from The Editor: The shameful vacancy at USDA

Wed, 12/13/2017 - 00:00

For those marking time, waiting for a new USDA Under Secretary for Food Safety, today is something of an anniversary. It was four years ago today that Dr. Elisabeth Hagen stepped down from the post.

The top food safety job in the federal government remains vacant.

Neither President Barack Obama nor President Donald Trump has appointed Hagen’s  successor. The U.S. Senate has not received any name seeking confirmation.

The 1993-94 USDA Reorganization Act requires the president to appoint someone to the top food safety job, and the Senate must vote up or down on confirmation. In the 24 years since then, the White House has sent only four nominations over to the Senate for confirmation.

Dr. Hagen served for three of the eight years of the Obama Administration. Dr. Richard Raymond and Professor Elsa Murano each held the job for about three years during the George W. Bush Administration. And Under Secretary Catherine Woteki served about the same amount of time in President Bill Clinton’s Administration.

All four were distinguished appointments with enough gravitas to oversee the $1 billion Food Safety and Inspection Service (FSIS), which assigns inspection personnel to about 6,500 meat, poultry, egg and catfish businesses across the country.

A year into his term, Trump seems no closer to making this appointment than he was on Jan. 20, 2017. But that’s not unusual. Obama was two years into his term when he finally got around to naming Hagen, and she was not hard to find as she was already serving as USDA’s chief medical officer.

It is the trend line that is peculiar. Obama went without an Under Secretary for Food Safety for five of his eight years. It’s soon going to be vacant more often than filled ever since established.

That does not seem to happen with other top federal government jobs that everyone agrees are important. Why does it happen again and again with the Under Secretary for Food Safety? The political parties are in a conspiracy of silence on this one.

We’ve learned that when there is Senate-confirmed Under Secretary for Food Safety on the job is when USDA makes advancements in food safety. Hagen’s work on E. coli strains and mechanically tenderized beef labeling are examples. She declared six additional strains of E. coli as adulterants to help prevent illnesses.

The people who fill in on an acting basis or as deputies do well enough, but they do not have the clout within the USDA bureaucracy that a confirmed Under Secretary for Food Safety has.

But if past is prologue, those who are serving on an acting basis now should be prepared for a long haul.

We begin year No. 5 without a USDA Under Secretary for Food Safety.

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E. coli cases linked to romaine lettuce; 21 sick, 10 hospitalized

Tue, 12/12/2017 - 15:51

Outbreak investigators are warning the public that romaine lettuce linked to an outbreak of E. coli O157 in Canada is a potentially deadly strain having already hospitalized half of the victims.

Three provincial health departments are reporting outbreak cases, with 21 sick people confirmed so far. Ten of the victims have had symptoms so severe that they required hospitalization. The Public Health Agency of Canada posted an outbreak notice Monday. The agency did not report whether the outbreak is ongoing.

“Individuals became sick in November 2017. Ten individuals were hospitalized. No deaths have been reported. Individuals who became ill are between the ages of 5 and 72 years of age” the federal health agency reported.

“Many individuals who became sick reported eating romaine lettuce before their illnesses occurred. The Canadian Food Inspection Agency (CFIA) is working with public health officials to determine the source of the romaine lettuce that ill individuals were exposed to.”

Health officials did not report the onset dates for the 21 sick people, so it is not known if any illnesses began in late November, which would suggest some of the implicated romaine lettuce could still be in the stream of commerce.

Tuesday a spokeswoman for the federal health agency referred Food Safety News to the outbreak notice, stating it had all of the currently available information.

The notice does not indicate when public health officials became aware of the November outbreak or why it was not revealed to the public until Dec. 11.

Also, the health agency notice does not provide any information on the brands of lettuce or retailers that sold it. Neither the health agency nor the Canadian Food Inspection Agency has posted any information about recalls of any romaine lettuce or other foods about the outbreak.

“The outbreak investigation is ongoing, and this public health notice will be updated on a regular basis as the investigation evolves,” according to the notice.

Currently, there are 21 cases of E. coli O157 illness under investigation in three provinces: Quebec with 3 cases, New Brunswick with 5 cases, and Newfoundland and Labrador with 13 cases.

Advice to consumers
Although anyone can get an E. coli infection, pregnant women, those with weakened immune systems, young children and older adults are most at risk for developing severe complications. Anyone who has eaten romaine lettuce and developed symptoms of E. coli infection should immediately seek medical attention.

Symptoms can include nausea, vomiting, headache, mild fever, severe stomach cramps, and watery or bloody diarrhea. The onset of symptoms can range from 1 to 10 days after exposure.

“Some do not get sick at all, though they can still spread the infection to others. Others may feel as though they have a bad case of upset stomach. In some cases, individuals become seriously ill and must be hospitalized,” according to the health agency notice.

“People who develop complications may need further treatment, like dialysis for kidney failure.”

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Certain Tim Hortons patrons should seek Hepatitis A treatment

Tue, 12/12/2017 - 00:02

Another restaurant worker in Michigan has tested positive for hepatitis A, this time at a Tim Hortons location in Monroe, igniting another round of recommendations from public health officials that restaurant patrons seek post-exposure treatment immediately.

The post-exposure treatment for the highly contagious virus must be given within two weeks of exposure, otherwise it is not effective.

Monroe County Health Department (MCHD) officials reported the infected employee works at Tim Hortons, 404 S. Monroe St. Anyone who consumed food or drink from the restaurant between Nov. 21 and Dec. 8 may have been exposed.

“MCHD is working closely with the restaurant to vaccinate all employees and to eliminate any additional risk of exposure,” according to a news release. The restaurant is cooperating with health officials. The infected employee is not currently working and is receiving medical treatment.

It is important for people to obtain the post-exposure treatment even if they are not exhibiting any symptoms. It usually takes two to six weeks for symptoms to develop, which is too long after exposure for the vaccine to prevent infection from developing.

Symptoms can include fatigue, poor appetite, stomach pain, nausea, vomiting, dark urine, and jaundice, according to the health department.

The Tim Hortons employee is the most recent foodservice worker to be reported with the virus, which has hit Southeast Michigan particularly hard. The state is one of several in the midst of an ongoing hepatitis A outbreak that has sickened more than 1,300 people.

In Michigan, 583 victims had been confirmed as of Thursday. Twenty of them have died. Many of the victims have been homeless people and substance abusers, but about a third are in neither of those groups.

Some public health agencies in Michigan are encouraging all foodservice employees who have not been vaccinated against the virus to seek hepatitis A vaccinations now. A number of free and reduced-cost vaccination clinics are available around the state.

 Detroit Health Department
Phone: 313-876-4000  Monroe County Health Department
Phone: 734-240-7800  Central Michigan District Health Department
Isabella Phone: (989) 773-5921  Oakland County Health Division
Phone: 1-800-848-5533 or Email: noc@oakgov.com  Ingham County Health Department
Phone: 517-887-4311  St. Clair County Health Department
Phone: 810-987-5300  Lapeer County Health Department 
Phone: 810-667-0448  Sanilac County Health Department
Phone: 810-648-4098  Livingston County Health Department 
Phone: 517-546-9850  Washtenaw County Public Health
Phone: 734-544-6700  Macomb County Health Department
Phone: 586-469-5372  Wayne County Department of Health, Veterans & Community Wellness 
Phone: 734-727-7078

 

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Do FDA ‘guidance’ documents skirt the regulatory process?

Tue, 12/12/2017 - 00:01

The Food and Drug Administration’s penchant for “guidance” documents as opposed to formal rulemaking needs to end, according to a business-oriented public interest legal foundation.

“FDA’s turn away from notice-and-comment rulemaking has an obvious motive: Formal rulemaking can be quite cumbersome, and FDA would prefer where possible to avoid the time and expense involved,” says attorney Richard Samp. “But the agency’s embrace of informal rulemaking imposes significant and unwarranted regulatory burdens on affected businesses.”

Samp is chief counsel for the 40-year-old Washington Legal Foundation (WLF).

While WLF’s seven-page comment was in response to how FDA might improve regulations on drug evaluations, the agency frequently uses guidance documents to direct food safety efforts as well.

Samp says FDA’s “heavy reliance” on guidance documents as a regulatory tool undercuts the notice-and-comment rulemaking requirements of the federal Administrative Procedure Act (APA) of 1946 and imposes excessive burdens on regulated businesses.

The WLF comments suggest FDA should begin curtailing its use of both guidance and draft guidance documents. It points to two Executive Orders issued by President Donald J. Trump, directing agencies to reduce regulatory burdens on the public.

“There is no question that FDA guidance documents are encompassed with the review process mandated by the two executive orders,” WLF’s comments say. Both executive orders cover any “agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy.”

While FDA routinely states that guidance documents do not operate to bind FDA or the public, it also emphasizes that such documents embody FDA’s “current thinking” on regulatory issues. Also, agency enforcement personnel regularly point to guidance documents as their basis for concluding that a regulated entity is not complying with the federal Food, Drug, and Cosmetic Act.

In documenting FDA’s increasing reliance on guidance documents, WLF says the agency has released more than 2,000 guidance and draft guidance documents in recent decades. Many cover topics that were previously covered by formal regulations. The FDA has standard language that accompanies its guidance documents:

“This guidance represents the Food and Drug Administration’s (FDA or Agency) current thinking on this topic. It does not establish any rights for any person and does not bind FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance using the contact information on the title page.”

The Washington Legal Foundation says businesses cannot afford to ignore guidance and draft guidance documents from FDA, but it’s not possible to get courts to review them because of their informal nature.

Federal courts recognize the value of “notice and comment” requirements for public involvement, fairness, and creating a record for judicial review. FDA “in recent decades” has been “far less likely” to adhere to formal regulatory processes, according to the group.

It also calls for these reforms:

  • Draft guidance should automatically expire if not placed into final status within two years.
  • Any guidance that has been in effect for at least five years should be subjected to formal review to determine whether the subject matter of the guidance would more properly be incorporated into formal regulation.
  • No guidance will be issued in draft or final form until after FDA has made a formal determination that the use of APA notice-and-comment procedures is not feasible.

Among its involvements with the FDA regulatory processes, WLF has litigated FDA’s authority to restrict manufacturer speech, including the dissemination of medical texts and peer-reviewed journal where it said FDA’s attempted regulation was “particularly inept.”

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Holiday Hazard: ‘Canned’ bread a recipe for botulism poisoning

Tue, 12/12/2017 - 00:00

Holiday baking is a staple for many gift givers, but bread makers should take caution: Making bread in canning jars creates a readymade package, but poses life-threatening risks.

According to the National Center for Home Food Preservation, some bread and cake recipes call for baking in canning jars and then closing with a canning lid. However, these recipes have very little or no acid, providing the perfect habitat for the growth of Clostridium botulinum and its toxin that causes botulism poisoning. Botulism is a sometimes fatal foodborne illness that paralyzes muscles, including respiratory muscles.

“When breads and cakes in jars are made for sale commercially by reputable companies, additives, preservatives and processing controls (that are) not available for home recipes are used,” according to University Extension Food Specialists from the University of Georgia. “Safety tests would have been conducted for each specific recipe for commercial products.”

The National Center for Home Food Preservation also reminds consumers that canning jar manufacturers do not endorse baking in their canning jars, for a variety of reasons.

Additionally, there is a risk of consuming broken glass from bread and cakes baked jars. Since canning jars are intended for use with moist heat, in boiling water baths or pressure canners, they are not made to withstand the “thermal stresses” that dry oven heat inflicts during baking.

The UGA Extension report concluded that because “no reliable, safe recipes for baking and sealing cakes or breads in jars for room temperature storage are available to the home cook, it is best to say these products are not recommended at this time.”

Also, frozen recipes should always be chosen over their room-temperature counterparts to help eliminate the growth of dangerous bacteria. Kick the canning jars to the curb and keep freshly baked bread and cakes a food safe gift this season of giving.

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Lack of food safety knowledge can be a problem for retailers

Mon, 12/11/2017 - 00:02

Editor’s note: This is the third of a four-part series on technology and food safety sponsored by PAR Technologies.

Pizza, meatloaf, pasta salad, deli sandwiches, rotisserie chicken, a full Chinese food buffet – and yes, even sushi are common fan favorites found in supermarket café’s and deli section for grocery shoppers wanting to dine in or pick up a quick and easy meal while grocery shopping.

While this diversification in retail offerings opens the door to winning over cliental, the same door also opens supermarkets up to liabilities in the event of a food safety compromise or its prepared products.

According to Donna F Schaffner, Associate Director in Food Safety, Quality Assurance and Training for Rutgers Food Innovation Center, using Hazard Analysis and Critical Control Points, better known as HACCP, is an effective way to reduce dangers.

Ensuring that food prepared by store employees is done so in a way that comples with the Food Safety Modernization Act is crucial, especially with high-risk foods such smoked meats, pickled or fermented products, sushi and during reduced-oxygen packaging of foods.

While food safety and HACCP should be at the forefront of every retailer’s agenda behind the deli counter, it can sometimes become compromised because of a lack of understanding of its importance.

“With some notable exceptions, the managers of grocery stores seldom seem to understand the significance of the potential food safety hazards that could be generated in their deli departments, and do not require their food preparation employees to attend a HACCP certificate training,” Schaffner said.

Such a lack of understanding may lead to using a “whatever is available” approach to operations rather than following the HACCP plan. That, Schaffner said, can cause food safety compromises such as cross-contamination of by allergens and pathogens. While this unavailability of knowledge and understanding is the most common issue Schaffner sees, she said the high rate of turnover for employees in food service adds another difficult layer in terms of adequate employee training.

According to Schaffner, advancements in technology have made implementation of HACCP in retail stores easier while overcoming challenges.

“Several companies are offering standard-template type computer programs for documenting and storing the records of HACCP checks in the food service environment,” Schaffner said.

Other pieces of technology include better designed paper towel dispensers to encourage employees wash and dry hands properly, training aids such as UV sprays to make germs visible to the naked eye, automated temperature tracking sensors, and preloaded HACCP checklists on handheld devices, notes Schaffner.

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Briefly: Hot stockings — Healthy as a horse — Drugs down

Mon, 12/11/2017 - 00:01

Every hour of every day people around the world are living with and working to resolve food safety issues. Here is a sampling of current headlines for your consumption, brought to you today with the support of Alchemy Systems.

Watchdog group pleased with drug drop
The Food and Drug Administration’s 2016 results show a 10 percent decrease in antimicrobials sold for use in animals, which is good news for animals and people, according to the Center for Food Safety.

The continuation of such declines in recent years is an encouraging development, signaling “a lasting change in the food industry,” according to Cameron Harsh senior manager for Organic and Animal Policy at the center.

This step toward safer food is partly a result of big companies like McDonald’s, Subway and KFC asking suppliers to eliminate unnecessary uses of antibiotics in chicken during the last few years, after pressure from various organizations, including the Center for Food Safety.

A threat to food safety, “misuse of antibiotics important to human medicine in food animals is linked to the development and spread of antibiotic-resistant bacteria that pose significant harm to humans. Antimicrobials have been routinely used to promote rapid weight gain and keep animals from succumbing to illness and disease in overcrowded, filthy conditions,” according to the center.

John (right), ridden by owner Doug Parker, overcame botulism poisoning to qualify for the World Series of Team Roping. Courtesy of UC-Davis

‘John’ is healthy as a horse again
Near death earlier this year because of food poisoning, a champion roping horse has recovered from a case of botulism linked to contaminated grain. Doug Parker, owner-rider of “John” was quick to seek help, as a stablemate had previously died from a case of botulism.

Emily Schaefer, a resident at the UC Davis Veterinary Medicine Center, said that when John arrived for treatment, “he preferred to lay down for long periods and eventually became so weak that he could not physically get up without help. He was becoming paralyzed.”

John remained hospitalized at UC Davis for 26 days. During that time, he was treated with botulism anti-toxin plasma. He received other supportive care including intravenous fluid therapy, anti-inflammatories, and vitamin E.

Clostridium botulinum, the bacterium that produces the toxins that cause botulism, is sometimes found in human food, especially in improperly home-canned foods. The infection is life threatening and is just as dangerous to horses and other domesticated animals as it is to people.

In humans, symptoms can include double or blurred vision, slurred speech, difficulty swallowing, dry mouth, thick-feeling tongue, and general muscle weakness. Patients often spend a long time on respirators because the toxin paralyzes muscles used for breathing

Hot stocking stuffer for college cooks
Along with the majority of their parents, college students put themsevles and others in danger every day by incorrectly assessing the color, firmness, color of juices or shrinkage as indications of whether meat, poultry and other foods are cooked.

Food thermometers are an essential step in preventing foodborne illness from E. coli, Salmonella, Listeria and other bacteria, viruses and parasites, according to public health officials at all levels.

“Using thermometers is the only way to really know your food is thoroughly cooked, and that it has reached a temperature that will destroy any harmful bacteria,” according to the Michigan State University Extension Service.

About two-thirds of people own food thermometers, but less than 10 percent actually use them. The Extension Service says looking for visual signs of doneness can result in food becoming overcooked and dry, whereas using a food thermometer can assure that the food has reached a safe temperature and is not overcooked.

There are a variety of different types of food thermometers, any of which fit nicely into a holiday stocking.

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FDA warns dairy, airline caterer, seafood and juice importer.

Mon, 12/11/2017 - 00:00

A Nebraska dairy, an airline catering facility, and a New York seafood and juice importer are all on notice from the Food and Drug Administration for violations of federal food safety rules.

The FDA sent the warning letters to the companies in May, November andDecember, and posted them for public view in recent days. Companies are allowed 15 working days to respond to FDA warning letters. Failure to promptly correct violations can result in legal action without further notice, including, without limitation, seizure and injunction.

Hilgenkamp Farm Inc., Arlington, NB
In a Nov. 15 warning letter to owners Milton and Ronald Hilgenkamp, the FDA described violations observed during an inspection Sept. 12 through 14 at the Hilgenkamp Farm Inc. operation in Arlington, NB. Investigators found that the firm holds animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the human food supply.

The FDA’s inspectors discovered drug residues in a dairy cow the company sold for slaughter as human food.

On or about May 24, the animal was slaughtered, according to the warning letter. During routine testing of tissue samples from the animal the USDA’s Food Safety and Inspection Service (FSIS)  found the antibiotic ceftiofur in the kidney at 6.691 parts per million (ppm), and the presence of flunixin at 0.213 ppm in the liver tissue.

The legal limit under federal law is 0.4 ppm for residues of ceftiofur in the edible tissues of cattle, and 0.125 ppm for residues of flunixin in edible tissues.

The dairy owner also failed to maintain adequate treatment records, according to FDA inspectors. Records on hand did not include the drug administered, dosage given, and route of administration. The firm also failed to maintain an adequate inventory system for determining the quantities of drugs used to medicate animals, and failed to segregate treated animals. Specifically, “you keep treated animals together in the same pen with non-treated animals,” in which a treated animal could be offered for sale before proper meat withdrawals are met.

“We also found that you adulterated the new animal drug CeftiFlex® (ANADA 200-420, ceftiofur sodium sterile powder). Specifically, our investigation revealed that you did not use CeftiFlex® as directed by its approved labeling. Use of this drug in this manner is an extralabel use.”

The firm’s extralabel use of CeftiFlex® was not under the supervision of a licensed veterinarian and also resulted in illegal drug residues, according to the warning letter.

The dairy owner responded to the FDA’s warning letter, but it was “not adequate,” for example:

  • The firm indicated that only one person, the herdsman, will have access to the drugs and will be allowed to treat animals. “In a dairy operation, such as yours, it appears unrealistic to expect one person to be on duty 365 days a year.” The firm did not address how or who will be responsible for drug treatments when he is not on duty.
  • The firm not include any physical separation of animals being treated. During the inspection, the firm explained they physically separate animals into a hospital pen and mark them with a colored leg band when animals are under a drug withdrawal period for milk residues. But animals that are under a withdrawal time for meat residues are placed back with the rest of the cows with no such physical separation or markings.

“You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur,” the FDA advised.

As a producer of animals offered for use as food, firms are responsible for ensuring that their overall operation and the food they distribute is in compliance with the law.

Tufos To Go LLC, Hebron, OH

In a May 19 warning letter to company owner Steven H. Tufo the FDA described violations observed during an inspection between May 25 and June 8 at the firm’s airline catering facility in Hebron, OH. According to the warning letter, the investigators observed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods.

The violations cause products produced in the firm’s facility to be adulterated  “…in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to heath.”

The following significant violations are noted regarding the adulterated foods:

  • All food-contact surfaces, including utensils and food-contact surfaces of equipment, are not cleaned as frequently as necessary to protect against contamination of food;
  • Buildings, fixtures, and other physical facilities of the plant are not being maintained in a sanitary condition or kept in repair sufficient to prevent food from becoming adulterated within the meaning of the act;
  • Cleaning and sanitizing of utensils and equipment is not being conducted in a manner that protects against contamination of food, food-contact surfaces, or food packaging;
  • All operations in the receiving, inspecting, transporting, segregating, preparing, manufacturing, packaging, and storing of food are not being conducted in accordance with adequate sanitation principles;
  • Appropriate quality control operations were not employed to ensure that food is suitable for human consumption, and overall sanitation of the plant is not under the supervision of one or more competent individuals assigned responsibility for this function;
  • Sanitizing agents are not adequate and safe under conditions of use;
  • Cleaned and sanitized portable equipment with food-contact surfaces and utensils were not stored in a location and manner that protects food-contact surfaces from contamination;
  • Toxic cleaning compounds, sanitizing agents, and pesticide chemicals were not identified, held, and stored in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials;
  • Employees were not observed washing their hands thoroughly in an adequate hand-washing facility before starting work, after each absence from the work station, and at any other time when the hands may have become soiled or contaminated;
  • Effective measures are not being taken to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests;
  • All plant equipment and utensils are not so designed and of such material and workmanship as to be adequately cleanable, and properly maintained;
  • Single-service articles are not being stored in appropriate containers or handled in a manner that protects against contamination of food or food-contact surfaces; and
  • The firm failed to provide sufficient space for such placement of equipment and storage of materials as is necessary for the maintenance of sanitary operations and the production of safe food.

According to the warning letter, the FDA acknowledged receipt of a written response from the firm. However, after reviewing the information, the FDA determined that the response is inadequate because it does not include sufficient detail or supporting documentation for the corrective actions. The FDA added that “These reported corrections will be evaluated during a subsequent inspection of your firm.”

Additionally, FDA records indicate that, to date, the firm’s facility has not been registered with FDA; “The owner, operator, or agent in charge of your facility, or an individual authorized by your facility’s owner, operator, or agent in charge, should register the facility with FDA immediately.”

Bedessee Imports Inc., Brooklyn, NY
Bedessee Imports Inc. in Brooklyn, NY, is on notice from the FDA because of significant deviations from the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation, the juice Hazard Analysis and Critical Control Point regulation, and the Current Good Manufacturing Practice regulation for foods under the Federal Food, Drug, and Cosmetic Act (the Act). The firm imports fish and fishery products, and juice, to their U.S. facility.

Staff from the Food and Drug Administration inspected the Brooklyn, NY, location of Bedessee Imports Inc. from May 2 through May 16. They discovered the “serious violations” regarding the firm’s affected products, according to a Dec. 1 warning letter made public by the FDA in recent days.

“As an importer of fish or fishery products, you must operate in accordance with the requirements, … there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply,” according to the warning letter sent to company president Verman Bedessee.

If upon inspection, the FDA does not find assurance that the imported fish or fishery product have been processed under conditions that are equivalent to domestic processor requirements, then the fish or fishery products will appear to be adulterated under the Act, and will be denied entry.

“Your Ready-to-eat Sardines in Tomato Sauce and Tomato Sauce with Chili and Ready-to-eat Mackerel in Water, Tomato Sauce, Hot Tomato Sauce and Soya Oil are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health,” according to the warning letter.

The FDA also found serious deviations from the juice processing regulation. As “an importer of juice”, the firm’s “Fruit of Life Coconut Water (No Pulp)(Diabetic Choice)(17.5 oz/ 520 ml)” was found, “adulterated in that it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health.”

Additionally, the claims on the firm’s website “establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease,” resulting in the firm’s Fruit of Life Coconut Water 100% Frozen Pouch, Fruit of Life Coconut Water No Pulp, Fruit of Life Coconut Water with Pulp, Fruit of Life Coconut Water Diabetic Choice 100% Natural, and Fruit of Life Coconut Water 100% Natural Frozen to be misbranded.

“Your productsFruit of Life Coconut Water 100% Frozen Pouch, Fruit of Life Coconut Water No Pulp, Fruit of Life Coconut Water with Pulp, Fruit of Life Coconut Water Diabetic Choice 100% Natural, and Fruit of Life Coconut Water 100% Natural Frozen are intended for the treatment and prevention of one or more diseases that are not amenable to self-diagnosis or prevention without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, these products fail to bear adequate directions for their intended use and, therefore, the products are misbranded.”

Additionally, the FDA investigator observed the following significant violations of the Current Good Manufacturing Practice regulation for foods:

  • The firm failed to provide, where necessary, adequate screening or other appropriate protection against pests; “Specifically, the FDA investigator observed 13 plastic strips in the loading dock that barred birds from entering the facility were cut and/or torn and three pigeons were observed roosting in the loading bay while the overhead door was open.”
  • The firm failed to provide sufficient space for placement of equipment and storage of materials as is necessary for the maintenance of sanitary operations and the production of safe food; “Specifically, the FDA investigator observed pallets were stored directly against walls and in aisles hampering cleaning and inspection.”
  • The firm failed to store and dispose of rubbish to minimize the potential for waste becoming an attractant and harborage or breeding place for pests; “Specifically, your firm was storing numerous empty boxes just inside the overhead door in the loading dock, just beyond an overhead door left ajar. Empty boxes and other debris may contribute to pests and pest harborage sites within food storage areas of your facility.”

FDA officials warned that they may pursue additional enforcement actions if the firm does not promptly correct these violations.

“You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action by FDA without further notice, including, without limitation, seizure and injunction.”

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Food bank recalls candy for chemical risk; two people sick

Sun, 12/10/2017 - 00:00

Federal officials and local police are warning the public about “Bibi Frutix” candy in small plastic containers shaped like baby bottles because it is expected of containing a chemical substance that has sickened at least two people. Food banks distributed at least some of the implicated candy.

The Wamego (KS) Police Department posted this photo of the implicated candy on its Facebook with a public warning after receiving reports of illnesses.

The Wamego (Kansas) Police Department posted its warning Dec. 5 after receiving several reports about the candy, including two about people who had “adverse reactions.” The department posted a photo of the implicated candy, saying its label indicates it is a product of Mexico.

“While this is an isolated report it is unknown where the candy has been distributed as the candy was not purchased at a local store,” according to the Wamego Police Department warning.

“The powdery substance — normally sugar — has not been analyzed at this time. However several people who sampled contents reported the powder had a chemical taste and two people had adverse reactions.”

A similar warning from the U.S. Food and Drug Administration, dated Dec. 8, included similar information, but referenced only one reported illness.

“A partner food pantry agency in Wamego, KS, notified Harvesters — The Community Food Network of potentially contaminated Bibi Frutix candy product it received through Harvesters’ distribution program,” according to the warning posted Dec. 9 on the FDA’s website.

“Harvesters followed recall procedures, including issuing a recall notice to all of its food pantry partners and checking to see if any product remained in its warehouses. To date, no product has been found beyond what was involved in the initially reported incident in Wamego, KS.”

It was not clear from the police and FDA notices whether the implicated candy, which was donated to Harvesters, had been distributed to retailers, wholesalers or other charitable food distribution entities. Harvesters officials estimated they received six or fewer cases of the candy.

However, the FDA reported that Harvesters agencies in a 19-county area in Kansas and Missouri, including the Kansas City metro area, could have received the candy.

Harvesters’ agencies that could have received the product are located in the following 19 counties of Harvesters’ service area in Kansas and Missouri are:

  • Kansas — Johnson, Wyandotte, Miami, Franklin, Douglas, Jefferson, Shawnee, Nemaha, Pottawatomie, Wabaunsee; and
  • Missouri — Jackson, Platte, Clay, Ray, Lafayette, Johnson and Bates. Harvesters continues to cooperate with local and state authorities to determine the potential scope of the distribution.

The FDA has advised, if a member of the community has possession of the candy product, do not consume the product and dispose of it immediately.

People who experience symptoms should contact their health care provider for treatment. If you believe product you received was contaminated, you may file a complaint with the FDA consumer complaint coordinator for Kansas and Missouri at 800-202-9780.

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