Tag Archives: recall

Dr. Peyman Fatemi, Vice President of Scientific Affairs, The Acheson Group
Beltway Beat

Market Withdrawal Vs. Recall: What’s the Difference?

By Peyman Fatemi, Melanie J. Neumann
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Dr. Peyman Fatemi, Vice President of Scientific Affairs, The Acheson Group

Determining whether to initiate a market withdrawal or recall procedure depends on the situation and unfortunately, is not always a clear-cut decision. Whether due to a lack of insights into the intricacies of recall management nuances o r because you simply cannot please everyone all the time, even using the best judgment can still cause upset. Take, for example, the 2013 Chobani yogurt incident: Let’s look at some of the facts surrounding the case.

The Chobani Market Withdrawal

On August 31, 2013, Chobani initiated a market withdrawal of yogurt due to “quality concerns surrounding certain products, which were experiencing swelling or bloating.” On September 3, the company stated that the issue was caused by a type of mold “commonly found in the dairy environment”.

Although the mold (Mucor circ inelloides) was not considered to be a disease-causing foodborne microorganism and “should not pose a health risk to most consumers” (according to Chobani’s blog), the company moved from a voluntary market withd rawal of the product to a voluntary recall on September 5.

Chobani seemed to be following protocol on withdrawals and recalls, and it was providing daily updates to consumers on its blog, but it did not escape negative publicity. In fact, foodborne illness lawyer Bill Marler, who dedicated nine of his own blogs to the incident, stated, “This probably ranks near the top in a mismanaged recall/market withdraw/PR disaster that I have seen in 20 years.” And directed questions to Chobani, including: “Why did you at first try to quietly ‘withdraw’ the product instead of issuing a ‘recall?’”

Market Withdrawals vs. Recalls

So, when should you initiate a market withdrawal and when might does it need to be elevated it to a voluntary recall (and if so, at what recall class)? In addition, at what point does FDA escalate it to a mandatory recall? Or, when should you voluntarily inform FDA yourself?

Chobani’s issue was not an isolated case. There are several theories about why its recall received so much negative publicity. Was the company slow to initially respond? Could it have stayed on top of social media monitoring more proactively? Did it take too long to determine the need to elevate from a market withdrawal to a recall? Some would say yes. Others would say the company made the best decision it could with the facts it had at the time it had to make the decision. Whatever the reason—understanding the nuances between market withdrawals and recalls will help.

Since each case will be unique, there isn’t a hard-and-fast answer without discussing the particulars of each situation, but we can provide you with more information about withdrawals and recalls – so that your first reaction and call are, if nothing else, at least a bit less frantic.
FDA’s definitions:

Market withdrawal: When a product has a minor violation that would not be subject to FDA legal action. The company removes the product from the market or corrects the violation.
Recalls: Actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm’s own initiative, by FDA request, or by FDA order under statutory authority.
Class I: There is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Class II: Use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse health consequences is remote.
Class III: Use of or exposure to a violative product is not likely to cause adverse health consequences.

In the Chobani case, an initial assessment showed that “common mold” was a quality issue that did not violate food safety regulations or require a recall, so the company initiated a market withdrawal. However, as more people who consumed the yogurt allegedly became ill, the incident was escalated (although no confirmed link was established) and was eventually classified by FDA as a Class II recall.

Your company needs to ask this type of question when a product is found to be defective in any way. Not only which of the above definitions does it fit at this time, but also whether it is likely that the consequences could be more severe. Using Chobani as the example, perhaps the fact that containers were bulging and exploding would indicate that there was a component in the product that could potentially make people sick? You need to constantly reassess the situation and consider if a status or actions must change.

Additionally, you need to consider your brand reputation. No one really wants to go to the regulators and fess up to a mistake that may not become an issue. But, it’s kind of like telling Mom you accidentally spilled your red Kool-Aid on the carpet before she sees it. If immediately targeted, that stain just may come out – and she may even consider your scrubbing of the carpet and promise to NEVER again take red Kool-Aid into the living room as “corrective action” enough. But if it sits for a day and she finds it herself while you remain quiet, it could be permanent, her trust in you soiled, and the punishment more severe than if you would have just told her in the first place.

When in doubt, if you address the potential “stain” on your product and brand head on, admit to your error, be upfront about the cause – and what you are doing to correct it – to both FDA and your customers, FDA is likely to work with you on your situation, and your customers will forgive you and continue to buy your product once they know the issue has been corrected. Understanding the differences between market withdrawals and recalls will be key to possibly avoiding a “spill” in the first place.

Dr. David Acheson is the Founder and CEO of The Acheson Group
Beltway Beat

How the Blue Bell 483 Inspection Reports Affect Us

By Dr. David Acheson
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Dr. David Acheson is the Founder and CEO of The Acheson Group

FDA has released the 483 Inspectional Observation reports involving the Blue Bell facilities following the recent Listeria outbreaks in ice cream. While most of the information contained in a 483 is not a big surprise to a typical food safety expert, I was still struck by some of the observations. Below are extracted sections within the 483 language that raised some questions in my mind.

Point 1

“Failure to perform microbial testing where necessary to identify sanitation failures and possible food contamination… Plant Environmental Program was used as an indicator determining whether the cleaning and sanitation program was effective. However this sampli ng program failed to include the following:

  • Sampling food contact surfaces.
  • Determination of the Listeria spp. associated with the presumptive positive results.
  • Root cause analysis of why the cleaning and sanitizing treatments were inadequate in controlling the occurrences of microbiological contamination.”

Q: Does this mean that FDA expects us to do zone 1 testing on a routine basis?
A: Based on this 483 – the answer is yes. But, if so, when should this be done? Is post clean up and pre-start up adequate? I sure hope so!

Q: Does this mean whenever we identify Listeria spp. we need to get it typed to determine the type of Listeria?
A: Based on this 483, the FDA will write you up if you simply stop at Listeria spp.

Q: Does this mean that every time we have a positive finding, we must document a root cause analysis?
A: Maybe…or is it only when we have multiple positives?

Point 2

“You also stated the results of your daily total coliform sampling on finished product, in process product, and raw ingredients added post pasteurization were used as an indicator in determining whether the cleaning and sanitation program was effective. However, this sampling program failed to include the following:

  • Determination of the pathogenicity of the coliform isolates.

Q: Does this mean when we find coliforms in finished product, or in ingredients being added post lethality or with in-process product, we need to determine if any of the coliforms would be considered to be pathogens?
A: The answer would appear to be yes.

Point 3

“Failure to store cleaned and sanitized portable equipment in a location and a manner which protects food-contact surfaces from contamination.”

This observation was related to equipment that was being stored in a basement area uncovered and unprotected, and that same equipment would be re-cleaned and sanitized prior to use.

Q: If you are storing equipment that has a food-contact surface, should the food-contact surface area be fully covered and protected, even if you will clean and sanitize it prior to production?
A: Based on this observation, the answer is yes. When you store equipment you will later use and if it has a food contact surface, make sure you cover and protect that surface during storage.

Point 4

“All reasonable precautions are not taken to ensure that production procedures do not contribute contamination from any source. Specifically, you do not have cleaning and sanitizing procedures for employee shoes worn into the sanitary food production areas of the firm to ensure that any potential contamination risks are minimized.”

Q: Does this mean that, at all entries to a sanitary or RTE area, there needs to be a process for cleaning and sanitizing footwear?
A: While this is certainly a common industry practice, it appears to now be a requirement.

Point 5

“The design of equipment does not allow proper cleaning and maintenance. Specifically wooden pallets which are porous and not easily cleanable are used throughout your firm to store and transport raw ingredients, finished product, and packaging materials. The wood pallets were observed in different stages of damage and disrepair while they were being used in the kitchen, warehouse, freezer, production, and mixing areas. The top platform, bottom, and corners of the pallets were broken, discolored, and soiled. The wood pallets were also observed to be saturated from being used in the wet processing areas and were observed as having black mold-like residues and red stains.”

Q:
Is FDA declaring war on wood pallets?
A: Certainly wood pallets are known to be a potential problem, but FDA is making it clear that you should not use wood pallets if they are damaged, discolored or soiled – even to store packaging materials or containers of food that will subsequently be used in production.

Conclusion

There are always opportunities to learn from others’ 483s, however, the above 483 extractions a little alarming. Not many companies will speciate Listeria spp., they will treat a Listeria finding as though it were LM and act accordingly. But based on these 483s, FDA could issue a 483 if you don’t speciate your Listeria spp. They could issue a 483 if you don’t test your coliforms in finished product or raw ingredients being used in finished product to see if any are pathogenic.

The language in the Blue Bell 483s is sending a strong prevention message to the food industry. It is also clearly using FSMA-like approaches. I see some of the observations in these 483s as being grenades that FDA has lobbed out – and it will be interesting to see if they have pulled out the pins as FSMA continues to roll out and FDA kicks up its inspections of food safety plans and preventive controls a notch. My message to the industry is this: Watch out and learn from others’ mistakes.

Blue Bell Recalls All Products Over Listeria Concerns

By Food Safety Tech Staff
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Blue Bell pulls all of its frozen treats from the shelves of grocery stores and retail outlets nationwide.

Today Blue Bell Creameries recalled all of its products—ice cream, frozen yogurt, sherbet and frozen snacks—made at all Blue Bell facilities because they might be contaminated with Listeria monocytogenes. FDA has open investigations at the company’s facilities.

Consumers should not eat any of the recalled the products.  If these ice cream products are in your freezer, they should be thrown away or returned, even if some of them have been eaten without anyone becoming ill.

More information is available on the FDA Update: FDA Investigates Listeria monocytogenes in Ice Cream Products from Blue Bell Creameries

 

About 170,000 pounds of Beef Recalled in Chicago

Chicago-based El Cubano Wholesale Meats is recalling 169,620 pounds of beef products that may be contaminated with E. coli O157:H7 according to the Illinois Department of Agriculture.

The products subject to recall bear the establishment number “EST. 4653a” inside the USDA mark of inspection and establishment name “Iowa Best Beef”. The products were distributed by establishment “El Cubano” to retail stores and restaurants in Chicago.

Labels of the products have a “For Cooking Only” instructional statement. Product bearing the instructional or disclaimer statement can only be distributed to other official/inspected establishments that have an appropriate production process. Such a disclaimer is an indication that the product has not been tested for E. coli O157:H7 and implies that the pathogen may be a food safety hazard reasonably likely to occur in the product in the absence of controls.

The problem was discovered by IDOA personnel during routine inspection. The Illinois Department of Agriculture is concerned that some product may be frozen in restaurants/retail store freezers.

Environmental Monitoring Programs and The Cost of Failure

What happens when a food company does not have an effective environmental monitoring program in place? The cost of failure can be significant, warns Prof. Ann Draughon, ranging from placing contaminated food in the markets, to managing product recalls, and businesses getting shut down.

Effective Environmental Monitoring, Sampling and Testing (EMS) Programs are absolutely necessary to protect our consumers, and make safe food, and are also required from a regulatory and food safety point of view, and to verify that our food safety programs are working.

In a recent webinar, Prof. Ann Draughon offered some insights on what happens when such an EMS program is not set in place – the cost of failure is much greater, and the repercussions can be severe, she warns.

What is on the horizon with EMS given the new regulatory landscape under the Food Safety Modernization Act and the proposed rules? Prof. Draughon talked about the Mandatory Preventive Controls described in Section 103 of the Act that lists the following controls that FDA will require:

  • Environmental monitoring programs;
  • Sanitation and cleaning requirements;
  • Allergen control;
  • Mitigation of hazards; and
  • Supplier verification.

How will FSMA affect FDA’s regulatory sampling of food facilities and products? The volume of environmental samples will increase at a much higher rate than sampling for allergens or ingredients, she adds. And in order to meet such a high demand for environmental inspection and sampling, it will be important to have in place effective EMS programs. Prevention will be cost-effective and give companies the ability to detect and destroy the microorganism before they cause any issues. Prof. Draughon provided the following numbers as cost of reinspection: $224 per hour for domestic inspections, $325 per hour for foreign inspections, and cost of FDA reinspection in FY 2012 estimated to be around $21,000.

She described two case studies of companies that suffered bankruptcy, and business losses due to massive food safety related recalls, caused by inadequate or lack of environmental monitoring programs.

3M-Envi-Monitoring_March2015-1

“This company is currently bankrupt due to a massive recall. While they had a great food safety plan, they did not back it up with a strong EMS program,” Prof. Draughon explained.

Speaking about the second company, she explained that the strong and capable leadership had done everything right for the company, but what went wrong? “There was a:

  • 3M-Envi-Monitoring_March2015-2Lack of trend analysis of environmental data;
  • Lack of communication within company about any positives Listeria results;
  • Sporadic Listeria positives occurred – while the problem was fixed, they continue to reoccur and the source was never detected or fixed;
  • The company had a reactive EMS, but not proactive,” she explained.

What are some of the recurring problems due to ineffective EMS programs? Prof. Draughon listed these as:

  • Increased risk of recall;
  • Increase loss of product;
  • Increased liability exposure;
  • Build-up of pathogens and spoilage agents or chemicals in environment;
  • Lack of regulatory compliance; and
  • Reaction to problems, not prevention.

Based on this high cost of compliance, Prof. Draughon strongly recommended establishing an effective EMS program, which has the following attributes:

  • Focus on having the appropriate indicators and hazards;
  • Ensure the best procedures selected and validated;
  • Strong sampling plan, which is well-designed and dynamic;
  • Data analysis and data management; and
  • Education and training.

Learn more by listening to the series of webinars on Environmental Monitoring, presented by 3M Food Safety. Click here for more details.

Kraft Recalls Mac & Cheese Due to Possible Metal Pieces

The company is voluntarily recalling approximately 242,000 cases of select code dates and manufacturing codes of the Original flavor of Kraft Macaroni & Cheese Dinner – due to the possibility that some boxes may contain small pieces of metal.

Kraft Foods Group is voluntarily recalling approximately 242,000 cases of select code dates and manufacturing codes of the Original flavor of Kraft Macaroni & Cheese Dinner – due to the possibility that some boxes may contain small pieces of metal.

Approximately 6.5 million boxes of original flavor Kraft Macaroni & Cheese are involved in the recall.

KraftMac-CheeseThe recalled product is limited to the 7.25-oz. size of the Original flavor of boxed dinner with the “Best When Used By” dates of September 18, 2015 through October 11, 2015, with the code “C2” directly below the date on each individual box. The “C2” refers to a specific production line on which the affected product was made.

Some of these products have also been packed in multi-pack units that have a range of different code dates and manufacturing codes on the external packaging (box or shrink-wrap), depending on the package configuration (see table).

Recalled product was shipped to customers in the U.S. and several other countries, excluding Canada. The affected dates of this product were sold in only these four configurations:

  • 7.25 oz. box, Original flavor
  • 3-pack box of those 7.25 oz. boxes Original flavor
  • 4-pack shrink-wrap of those 7.25 oz. boxes, Original flavor
  • 5-pack shrink-wrap of those 7.25 oz. boxes, Original flavor

No other sizes, varieties or pasta shapes and no other packaging configurations are included in this recall. And no products with manufacturing codes other than “C2” below the code date on the individual box are included in this recall.

Kraft has received eight consumer contacts about this product from the impacted line within this range of code dates and no injuries have been reported. The recalled product was shipped by Kraft to customers nationwide in the U.S. The product was also distributed to Puerto Rico and some Caribbean and South American countries — but not to Canada.

Consumers who purchased this product should not eat it. They should return it to the store where purchased for an exchange or full refund. Consumers also can contact Kraft Foods Consumer Relations at 1-800-816-9432 between 9 am and 6 pm (Eastern) for a full refund. 

Click here for more information.

Undeclared Allergens Continue to Serve as a Primary Factor in Product Recalls

In the fourth quarter of 2014, undeclared allergens accounted for 50 percent of all FDA food-related recalled units and 83 percent of USDA recalled units.

In the past few months, retailers pulled hundreds of products from shelves after a spice supplier found traces of peanut proteins in their cumin spice – an ingredient that dozens of manufacturers use in products across the country.

Stericycle-Recall-March-2015

Ramifications from the recall, which began in December, still occur daily; over two months after the spice supplier first identified the issue. To some the recall may seem miniscule, however, to the nearly 15 million Americans the CDC says has food allergies, undeclared allergens can be a life-threatening scare.

Despite increasing regulations and industry scrutiny, undeclared allergens continue to serve as a primary cause of food recalls in the U.S. According to the latest Stericycle Recall Index, in the fourth quarter of 2014, undeclared allergens accounted for 50 percent of all FDA food-related recalled units and 83 percent of USDA recalled units.

According to FDA, the most common foods involved in food allergen recalls are bakery products, snack foods, candy, dairy products and dressings. The FDA also identifies the most common allergens causing the recalls as milk, wheat and soy.

Undeclared allergen recalls are often a result of a simple manufacturing operational error, such as mislabeling, mis-packaging or unintentional cross-contamination. In the U.S., manufacturers of FDA regulated foods are required to identify major food allergens on the label; if mistakes occur in manufacturing, companies may be subject to a product recall.

As recent recalls show, the more complex the supply chain, the more complex product recalls become. Globalization of the supply chain also complicates recalls, especially when regulatory agencies from multiple countries have different recall mandates. The Stericycle Recall Index highlights some of these unique challenges in the global supply chain, including accessibility to remote areas.

Companies with proactive recall strategies in place can navigate their supply chain with ease when a supplier or an undeclared allergen issue arises. Having these processes identified prior to an event can save valuable time, money and help a company maintain regulatory compliance, while also concentrating on future growth.

Click here to access the report.

Canadian Poultry Products Recalled for Lack of Import Inspection

The products subject to recall bear the establishment number “Canada 591”. These products were shipped to retail locations in Washington.

Sunrise Poultry Processors of Lethbridge, Alberta, is recalling approximately 2,705 pounds of poultry products that were not presented at the U.S. point of entry for inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The following poultry items, produced on Feb. 2, 2015, are subject to recall:

  • 40-lb. bulk cases of “Sunrise Poultry CHICKEN THIGHS.”
  • 25-lb. cases of “Sunrise Poultry CHICKEN THIGHS BONELESS.”
  • 25-lb. cases of “Sunrise Poultry BONELESS CHICKEN BREAST.”
  • 2.5-lb. cases of “Sunrise Poultry CHICKEN WHOLE FRYER.”
  • 4-lb. cases of “Sunrise Poultry CHICKEN WHOLE FRYER.”
  • 3.25 to 3.75-lb. cases of “Sunrise Poultry CHICKEN WHOLE FRYER.”

The products subject to recall bear the establishment number “Canada 591”. These products were shipped to retail locations in Washington.

The problem was discovered when the import facility reported to FSIS that product with an estimated date of arrival of Feb. 4, 2015, had not been received at that location.

FSIS and the company have received no reports of adverse reactions due to consumption of these products. Anyone concerned about a reaction should contact a healthcare provider.

Neogen Responds to Cumin and Spice Blend Contamination Involving Peanut

The company has announced that its comprehensive line of food allergen tests includes quantitative and screening test kits that can quickly and accurately detect peanut and almond allergens in cumin and spice blends.

In response to recent recalls of products containing cumin found to be contaminated with peanuts and almonds, Neogen has announced that its comprehensive line of food allergen tests includes quantitative and screening test kits that can quickly and accurately detect peanut and almond allergens in cumin and spice blends.

Neogen’s AOAC-approved Veratox® for Peanut Allergen has been validated to detect and fully quantify peanut residues in cumin in about 30 minutes, with minimal training and equipment. Neogen also offers its Alert® for Peanut Allergen, which screens samples at 5 parts per million (ppm), and is based on the same technology of its Veratox test. The company offers the same options to test samples for the presence of almonds. In addition, the Reveal® for Peanut Allergen test kit is an effective screening tool for the presence of peanut residues in these sample types.

For companies that prefer not to do their own on-site testing, Neogen also offers a rapid laboratory testing service at its locations in Lansing, Mich., and Ayr, Scotland.

“Both food allergic consumers and food producers rely on the accurate labeling of food products to protect themselves from the consequences of the accidental ingestion of food allergens,” said Tony Lupo, Neogen’s Director of Technical Services. “Testing that we have done with numerous raw ingredient and finished product samples containing cumin have detected the presence of peanuts, in high levels in some cases. Tests can protect businesses in the food value chain — and their consumers.”

Neogen’s tests detect both the nut and residual protein remaining in shell components of peanuts and almonds.

Neogen has created a special website where processors, producers and test labs can go for further information, including a new white paper on contaminated cumin. The address is www.neogen.com/CuminResponse. On the site you will find information on contacting Neogen to speak to a specialist, and be able to download our new white paper, our allergen supplier checklist, and our Food Allergen Control Handbook.

Neogen’s food allergen testing products have been developed in close cooperation with the University of Nebraska’s Food Allergy Research and Resource Program (FARRP). FARRP is a food industry and university partnership that was formed to provide research and resource tools to the food industry. It is the leader in training and educating the industry on allergen awareness.

Neogen Corporation develops and markets products dedicated to food and animal safety. The company’s Food Safety Division markets dehydrated culture media, and diagnostic test kits to detect foodborne bacteria, natural toxins, food allergens, drug residues, plant diseases and sanitation concerns. Neogen’s Animal Safety Division is a leader in the development of animal genomics along with the manufacturing and distribution of a variety of animal healthcare products, including diagnostics, pharmaceuticals, veterinary instruments, wound care and disinfectants.

Apple Recall – Here are 5 Fruits and Veggies at Greater Risk

“Fresh fruits and vegetables are probably the biggest source of foodborne illness today in North America, and that’s because they’re fresh — we don’t cook them — so anything that comes into contact has the potential to contaminate.”

A Listeria outreak in apples has killed seven people and hospitalized 31, according the Centers for Disease Control and Prevention, which has trace the outbreak to Bidart Bros. apple-packing plant in California.

While apples are the second most popular fruit in America, according the Agricultural Marketing Resource Center, outbreaks linked to apples are rare, due to the natural hard surface of the fruit, which, prevents bacteria from entering the fruit, says Doug Powell, PhD, a former professor of food safety in the U.S. and Canada who publishes barfblog.com.

In a Yahoo! Health article, Amy Rushlow quotes Prof. Powell: “Fresh fruits and vegetables are probably the biggest source of foodborne illness today in North America, and that’s because they’re fresh — we don’t cook them — so anything that comes into contact has the potential to contaminate.” Powell especially sounds caution about the following five fruits and vegetables, which have been linked to a significant number of foodborne illness outbreaks over the past years:

1. Sprouts: A 2011 outbreak in Germany killed more than 50 people and sickened more than 4,000. In late 2014, more than 100 Americans became ill after eating sprouts tainted with E. coli. Sprouts are particularly prone to bacteria because they germinate in a high-temperature, high-moisture environment — the same environment where germs thrive. The CDC recommends that pregnant women, children, older adults, and people with weak immune systems avoid eating raw sprouts. Cooking sprouts destroys harmful bacteria.

2. Cantaloupe: Cantaloupes’ porous rinds allow bacteria to enter the fruit. In addition, the fields where cantaloupes are grown are often flooded, resulting in the fruits sitting in water that may have come downstream from a livestock operation.”

3. Leafy greens: Bacteria becomes trapped on the inner leaves as the head is forming, and leafy greens are difficult to wash effectively. Over the past several years in the U.S., bags of romaine lettuce, prepackaged salad mix, spinach, and spring mix have all been linked to E. coli outbreaks.

4. Tomatoes: There are several ways for germs to enter the fruit of the tomato, including via groundwater or through the water tomatoes are plunged into to give them a little shine.

5. Garnishes, such as green onions, cilantro, and parsley: Green onions and other herbs and vegetables used as garnishes are at high risk for outbreaks because we typically don’t cook them.

However, Powell advises that while there is no one measure that will keep you completely safe, a few small steps can add up such as rinsing fresh produce, and cooking then when you can.

Source: Yahoo! Health