Shrimp Labeled as Chicken...Those Darn In-Store Print-and-Apply Labels - Whole Foods Market is voluntarily recalling packaged popcorn chicken with sweet chili sauce across 26 stores in Northern California and Reno, Nevada. The product is being recalled because it may contain undeclared shellfish (shrimp) that was not listed on the product label due to mislabeling. The product was sold in plastic containers in the prepared foods department and was labeled as “Popcorn Chicken Shaker with Sweet Chili” with sell by dates through Nov. 27, 2020.
How many issues have we had now related to store level errors on these labels?
Food Safety Humor
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FSPCA - Food Safety Preventive Controls Alliance
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Wednesday, November 25, 2020
Fresh-Pack Basil Recalled After State Laboratory Finds Cyclospora
Shenandoah Growers, Inc (Harrisonburg, VA) is recalling of approximately 15,000 units in select packages, due to a possible health risk from Cyclospora after a retail sample was tested by Florida Department of Agriculture on 11/2/2020 from a retail store in Florida indicated the potential presence of Cyclospora. These were packed under branded and private label fresh cut organic certified basil clamshells at its Jefferson, GA facility and Harrisonburg, VA facility with the following lot codes, all with the country of origin of Colombia.
Shennandoah Growers are one of these upcoming greenhouse operations that rely on indoor growing for controlled environment. (https://www.shenandoahgrowers.com/innovation). However, this product was from Colombia. The source of the cyclospora would be the irrigation water, and once there on the delicate leaves of the basil, it will not likely be removed through the gentle washing systems used. It is on SG to ensure that their supplier is using a good water source.
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/shenandoah-growers-inc-issues-limited-voluntary-recall-certain-imported-organic-basil-because
Shenandoah Growers Inc Issues a Limited, Voluntary Recall of Certain Imported Organic Basil Because of Potential Health Risk
Summary
Company Announcement Date: November 24, 2020
FDA Publish Date: November 24, 2020
Product Type: Food & Beverages
Reason for Announcement: Possible Cyclospora contamination
Company Name: Shenandoah Growers, Inc
Brand Name: The Fresh Market, Good & Gather and more
Product Description: Organic Basil
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/shenandoah-growers-inc-issues-limited-voluntary-recall-certain-imported-organic-basil-because
Shenandoah Growers Inc Issues a Limited, Voluntary Recall of Certain Imported Organic Basil Because of Potential Health Risk
Summary
Company Announcement Date: November 24, 2020
FDA Publish Date: November 24, 2020
Product Type: Food & Beverages
Reason for Announcement: Possible Cyclospora contamination
Company Name: Shenandoah Growers, Inc
Brand Name: The Fresh Market, Good & Gather and more
Product Description: Organic Basil
Fresh-Pack Chopped Vegetable Packs Recalled for Listeria
Hy-Vee, Inc., based in West Des Moines, Iowa, is voluntarily recalling two of its Hy-Vee Short Cuts vegetable mix products across its eight-state region (IL, IA, KS, MN, MO, NE, SD, and WI) due to possible contamination with Listeria monocytogenes. The potential for contamination was discovered during routine safety sampling at Hy-Vee’s Short Cuts production facility. To date, no illnesses have been reported in connection with these products.
This is a fresh vegetable mix that is designed to be used in a cooking application. In the case here, either for use as grilled or in a stew. Those processes, if properly cooked, would eliminate the Listeria organism. But it is hard to know whether the consumer will actually do that.
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hy-vee-voluntarily-recalls-two-short-cuts-vegetable-mix-products-because-possible-health-risk
Hy-Vee Voluntarily Recalls Two Short Cuts Vegetable Mix Products Because of Possible Health Risk
Summary
Company Announcement Date: November 24, 2020
FDA Publish Date: November 24, 2020
Product Type: Food & Beverages
Reason for Announcement: Potential to be contaminated with Listeria monocytogenes
Company Name: Hy-Vee, Inc.
Brand Name: HyVee
Product Description: Short Cuts vegetable mix products
This is a fresh vegetable mix that is designed to be used in a cooking application. In the case here, either for use as grilled or in a stew. Those processes, if properly cooked, would eliminate the Listeria organism. But it is hard to know whether the consumer will actually do that.
In chopping/slicing operations, Listeria can be a challenge. While there will be sanitizing steps in place for the vegetables, the sheer amount of moisture and organic material that is generated within that processing environment as well as the intricate nooks and crannies in the processing equipment (choppers and slicers), can create opportunities for this organism to become established.
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hy-vee-voluntarily-recalls-two-short-cuts-vegetable-mix-products-because-possible-health-risk
Hy-Vee Voluntarily Recalls Two Short Cuts Vegetable Mix Products Because of Possible Health Risk
Summary
Company Announcement Date: November 24, 2020
FDA Publish Date: November 24, 2020
Product Type: Food & Beverages
Reason for Announcement: Potential to be contaminated with Listeria monocytogenes
Company Name: Hy-Vee, Inc.
Brand Name: HyVee
Product Description: Short Cuts vegetable mix products
Tuesday, November 24, 2020
FDA Publishes Table of Foodborne Illness Investigations
FDA published a table or "list of outbreaks investigations being managed by FDA’s CORE Response Teams. The investigations are in a variety of stages, meaning that some outbreaks have limited information, and others may be near completion"
There are three E. coli outbreaks that we have reported on previously (1 and 2, 3),as well as a Salmonella outbreak linked to peaches occurring back in August. There are three other outbreaks of Salmonella that are still being investigated - one that is considered over, one linked to juice bar in Minnesota occurring in October, and then one other Salmonella case.
Popping over to the CDC website for ongoing foodborne illness outbreaks....the CDC also has a table listing more outbreaks that are being investigated, but even less information is provided. There are 5 Listeria outbreaks, 14 Salmonella outbreaks, and 4 E. coli outbreaks. Perhaps many of these occurred long ago, but the investigation continues?
It would be better to have additional information, where every item listed links to what is known including when the outbreak started or when it was first identified (we don't care about the posting date), when the last reported case occurred, the location of the cases, a link between FDA, CDC, and USDA tables, and impact of those affected.
There are three E. coli outbreaks that we have reported on previously (1 and 2, 3),as well as a Salmonella outbreak linked to peaches occurring back in August. There are three other outbreaks of Salmonella that are still being investigated - one that is considered over, one linked to juice bar in Minnesota occurring in October, and then one other Salmonella case.
Popping over to the CDC website for ongoing foodborne illness outbreaks....the CDC also has a table listing more outbreaks that are being investigated, but even less information is provided. There are 5 Listeria outbreaks, 14 Salmonella outbreaks, and 4 E. coli outbreaks. Perhaps many of these occurred long ago, but the investigation continues?
It would be better to have additional information, where every item listed links to what is known including when the outbreak started or when it was first identified (we don't care about the posting date), when the last reported case occurred, the location of the cases, a link between FDA, CDC, and USDA tables, and impact of those affected.
The presented information is good, but it leaves one with more questions that need to be addressed.
FDA - Investigations of Foodborne Illness Outbreaks
https://www.fda.gov/food/outbreaks-foodborne-illness/investigations-foodborne-illness-outbreaks
The following is a list of outbreaks investigations being managed by FDA’s CORE Response Teams. The investigations are in a variety of stages, meaning that some outbreaks have limited information, and others may be near completion.
A public health advisory will be issued for outbreak investigations that have resulted in specific, actionable steps for consumers to take to protect themselves. Please direct your attention to those pages for the most up to date information on the investigation and for consumer protection information.
Outbreak investigations that do not result in specific, actionable steps for consumers may or may not conclusively identify a source or reveal any contributing factors. If a source and/or contributing factors are identified that could inform future prevention, FDA commits to providing a summary of those findings.
FDA - Investigations of Foodborne Illness Outbreaks
https://www.fda.gov/food/outbreaks-foodborne-illness/investigations-foodborne-illness-outbreaks
The following is a list of outbreaks investigations being managed by FDA’s CORE Response Teams. The investigations are in a variety of stages, meaning that some outbreaks have limited information, and others may be near completion.
A public health advisory will be issued for outbreak investigations that have resulted in specific, actionable steps for consumers to take to protect themselves. Please direct your attention to those pages for the most up to date information on the investigation and for consumer protection information.
Outbreak investigations that do not result in specific, actionable steps for consumers may or may not conclusively identify a source or reveal any contributing factors. If a source and/or contributing factors are identified that could inform future prevention, FDA commits to providing a summary of those findings.
Canada - Pumpkin Pie Jam Recalled Due to Botulism Concerns
The Canadian Food Inspection Agency issued a recall notice for My Grandfather's Farm's Pumpkin Pie Jam after the agency indicated that the product would be able to support the growth of Clostridium botulinum. While not stated in the notice, one would guess that the pH was too high for the type of processing used - it was probably processed as an acidified food which requires a product pH of 4.6 or lower.
My complaint with the CFIA notices is that they lack information. Because of this, news reports vary in what they report, such as this report (https://cfox.com/news/7475321/pumpkin-pie-jam-recall-botulism-risk/) which states "The Canadian Food Inspection Agency (CIFA) says a Nova Scotia brand is recalling jam after a potential toxic bacteria was detected." Well, not exactly if you read the CFIA report below. CFIA can use these recalls as an opportunity to educate.
Canadian Food Inspection Agency Recall Notice
https://www.inspection.gc.ca/food-recall-warnings-and-allergy-alerts/2020-11-20/eng/1605894173720/1605894179669
Food Recall Warning - My Grandfather's Farm brand Pumpkin Pie Jam recalled due to potential presence of dangerous bacteria
From: Canadian Food Inspection Agency
Recall date: November 20, 2020
Reason for recall: Microbiological - Other
Hazard classification: Class 1
Company / Firm: My Grandfather's Farm
Distribution: Nova Scotia
Extent of the distribution: Retail
Reference number: 14094
My complaint with the CFIA notices is that they lack information. Because of this, news reports vary in what they report, such as this report (https://cfox.com/news/7475321/pumpkin-pie-jam-recall-botulism-risk/) which states "The Canadian Food Inspection Agency (CIFA) says a Nova Scotia brand is recalling jam after a potential toxic bacteria was detected." Well, not exactly if you read the CFIA report below. CFIA can use these recalls as an opportunity to educate.
Canadian Food Inspection Agency Recall Notice
https://www.inspection.gc.ca/food-recall-warnings-and-allergy-alerts/2020-11-20/eng/1605894173720/1605894179669
Food Recall Warning - My Grandfather's Farm brand Pumpkin Pie Jam recalled due to potential presence of dangerous bacteria
From: Canadian Food Inspection Agency
Recall date: November 20, 2020
Reason for recall: Microbiological - Other
Hazard classification: Class 1
Company / Firm: My Grandfather's Farm
Distribution: Nova Scotia
Extent of the distribution: Retail
Reference number: 14094
Monday, November 23, 2020
Romaine Hearts Recalled After Sample Tests Positive for E. coli
Dole Fresh Vegetables, Inc. is recalling a limited number of cases of organic romaine hearts due to a possible health risk from E. coli in the two products. The recall comes after "an isolated instance in which a package of Dole™ Organic Romaine Hearts – 3pk yielded a positive result for pathogenic non-O157 E.coli STEC in a routine sample collected at a retail store by the Michigan Department of Agriculture and Rural Development."
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dole-fresh-vegetables-announces-limited-recall-organic-romaine-hearts
Dole Fresh Vegetables Announces Limited Recall of Organic Romaine Hearts
Summary
Company Announcement Date: November 21, 2020
FDA Publish Date: November 21, 2020
Product Type: Food & Beverages Produce
Reason for Announcement: Potential for Pathogenic non-O157 E. coli
Company Name: Dole Fresh Vegetables Inc.
Brand Name: Dole and Wild Harvest
Product Description: Organic Romaine Hearts
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dole-fresh-vegetables-announces-limited-recall-organic-romaine-hearts
Dole Fresh Vegetables Announces Limited Recall of Organic Romaine Hearts
Summary
Company Announcement Date: November 21, 2020
FDA Publish Date: November 21, 2020
Product Type: Food & Beverages Produce
Reason for Announcement: Potential for Pathogenic non-O157 E. coli
Company Name: Dole Fresh Vegetables Inc.
Brand Name: Dole and Wild Harvest
Product Description: Organic Romaine Hearts
Date Expired Salad Kits Recalled After Sample Yields Positive E. coli Result
Fresh Express is recalling a limited number of cases of expired 10.5 oz. Fresh Express Kit Caesar Supreme with the Use-by Date of November 8, 2020 (already expired by 8 days) as it may be contaminated with Escherichia coli STEC 026 bacteria. The recalled product was distributed primarily in Western and Southwestern U.S. states. The recall was issued after a random test discovered the organism in a sample. There have not yet been any reported illnesses.
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresh-express-recalls-limited-quantity-expired-fresh-express-kit-caesar-supreme-due-potential-health
Fresh Express Recalls Limited Quantity of Expired Fresh Express Kit Caesar Supreme Due to Potential Health Risk
Summary
Company Announcement Date: November 17, 2020
FDA Publish Date: November 17, 2020
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresh-express-recalls-limited-quantity-expired-fresh-express-kit-caesar-supreme-due-potential-health
Fresh Express Recalls Limited Quantity of Expired Fresh Express Kit Caesar Supreme Due to Potential Health Risk
Summary
Company Announcement Date: November 17, 2020
FDA Publish Date: November 17, 2020
Product Type: Food & Beverages
Reason for Announcement: Escherichia coli STEC 026 bacteria
Company Name: Fresh Express
Brand Name: Fresh Express
Product Description: Fresh Express Kit Caesar Supreme.
Reason for Announcement: Escherichia coli STEC 026 bacteria
Company Name: Fresh Express
Brand Name: Fresh Express
Product Description: Fresh Express Kit Caesar Supreme.
FDA Warning Letter - Inadequate Controls to Prevent Allergen Mislabeling
FDA issued Ventura Foods facility in Birmingham, AL a Warning Letter following the company's recall of Garlic Parmesan Sauce that was labeled as Garlic Sauce. In this case the Garlic Sauce finished product labels did not declare major food allergens of milk and wheat. Further, we have determined that you did not follow the requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule)
The firm discovered that the Garlic Parmesan Sauce labeled as Garlic Sauce was at store level after being notified by a customer. According to the documentation issued to FDA, the mislabeling occurred because an operator brought an incorrect roll of labels to the line. Although the firm identified the mislabeling issue before the product left the facility, the firm did not re-label all affected jugs of product.
In an email from the firm, the firm causes and provided corrective and preventive actions. In particular, the firm indicated that they will use an improved label management process to pre-stage labels for each line and limit label room access; update procedures for label conversions and storage of new labels; require barcode scanning of gallon jugs; update a procedure to include details on how to properly escalate and manage nonconforming product; update a procedure to outline details regarding the proper handling of relabeling tasks; and will conduct training on all updated procedures by July 1, 2020.
The Warning Letter was issued on the fact the firm had not identified and implemented food allergen controls at the labeling step adequate to prevent mislabeling of allergen containing product. And the firm did not implement effective corrective action procedures to ensure that all affected product was evaluated for safety and prevented from entering commerce as evidenced by mislabeled Garlic Parmesan Sauce that reached customers.
The firm discovered that the Garlic Parmesan Sauce labeled as Garlic Sauce was at store level after being notified by a customer. According to the documentation issued to FDA, the mislabeling occurred because an operator brought an incorrect roll of labels to the line. Although the firm identified the mislabeling issue before the product left the facility, the firm did not re-label all affected jugs of product.
In an email from the firm, the firm causes and provided corrective and preventive actions. In particular, the firm indicated that they will use an improved label management process to pre-stage labels for each line and limit label room access; update procedures for label conversions and storage of new labels; require barcode scanning of gallon jugs; update a procedure to include details on how to properly escalate and manage nonconforming product; update a procedure to outline details regarding the proper handling of relabeling tasks; and will conduct training on all updated procedures by July 1, 2020.
The Warning Letter was issued on the fact the firm had not identified and implemented food allergen controls at the labeling step adequate to prevent mislabeling of allergen containing product. And the firm did not implement effective corrective action procedures to ensure that all affected product was evaluated for safety and prevented from entering commerce as evidenced by mislabeled Garlic Parmesan Sauce that reached customers.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ventura-foods-llc-609201-10282020
WARNING LETTER
Ventura Foods LLC
MARCS-CMS 609201 — October 28, 2020
WARNING LETTER
Ventura Foods LLC
MARCS-CMS 609201 — October 28, 2020
FDA Issues Warning Letters to Three Food Importers for FSVP Issues
FDA issued Warning Letters to three food importers for issues involving the Foreign Supplier Verification Program (FSVP). Two of these were remote audits.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/eh-distributors-llc-610883-11042020
E&H Distributors LLC
MARCS-CMS 610883 — November 04, 2020
- E & H Distributors LLC of , San Diego, CA did not have FSVPs for soft tamarind flavored candy from one supplier and candy imported from another foreign supplier.
- World Candy Store LLC, of Brownsville, Texas 78521. did not have FSVPs for these products, Ricolino Huevito Pinto imported from foreign supplier (b)(4), and Ricolino Huevito imported from foreign supplier (b)(4).
- WCS Trading Inc, of Los Angeles, CA 90032 did not complete a review of the supplier's hazard analysis and did not perform verification activities for dried crushed chili, dried black fungus and dried mushrooms
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/eh-distributors-llc-610883-11042020
E&H Distributors LLC
MARCS-CMS 610883 — November 04, 2020
FDA Warning Letter - RTE Salad Manufacturer Cited for Not Following Food Safety Plan
FDA issued a Warning Letter to Etai's Food, Inc of Denver Colorado, a manufacturer of RTE salad, sandwich, burritos, wraps, pasta and snack items. One of the primary themes is having items in the Food Safety Plan, but not doing them. If it is in the Plan, then you have to do it.
Issues
- Had not completed environmental sampling as they had detailed in the Food Safety Plan. They set a frequency, but did not have results to show to match that frequency as stated..
- Environmental samples completed showed some results as “indeterminate". The company had no corrective action written for indeterminate results nor did they take corrective action. FDA had "concerns based on these results (including the frequency of “indeterminate” results) and your lack of subsequent action that your procedures are not adequate to verify that your sanitation preventive controls are consistently implemented and are effectively and significantly minimizing or preventing the hazard of environmental pathogens."
- The Environmental Monitoring Program stated that the company would “Identify and Maintain a Master Site List” . There was no list.
- Regarding the Supplier Preventive Controls - the facility did not complete all of the items as stated in the plan including collecting audits and surveys.
- GMPs - poor personnel practices that can contribute to cross contact and cross contamination (improper glove usage, water hose usage) There were a number of items associated with allergen control including how products were stored.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/etais-food-inc-607977-11052020
WARNING LETTER
Etai's Food, Inc.
MARCS-CMS 607977 — November 05, 2020
WARNING LETTER
Etai's Food, Inc.
MARCS-CMS 607977 — November 05, 2020
Friday, November 20, 2020
Are Outdoor Dining Areas Any Less Risky for COVID as Indoor Eating Areas?
An interesting article in Business Insider discusses the use of outdoor eating structures that many restaurants have erected to provide service during this COVID pandemic. While it does provide extra seating for the restaurant to help expand what was lost indoors when social distancing actions were put in place to separate tables, there are some drawbacks.
For one, the thought this is actually outdoor is not necessarily true. Especially as the weather cools, these structures are probably not much different than indoor structures. These areas are essentially four walls and a ceiling and thus there is no advantage providing as would be had by truly being outside.
On top of that, there may be no air circulation thus not providing an escape for potential virus. Or air circulation may not be controlled, resulting in one person's exhaust being blown onto another person.
Sitting in these outside structures may give a person a false sense of security in thinking that they are really outside, so those individuals may be less attentive to the need for social distancing or mask wearing.
Business Insider
https://www.businessinsider.com/outdoor-dining-tent-safety-risks-explained-2020-11
Restaurants are setting up tents and temporary structures to extend outdoor dining during the winter. But they come with their own hazards, and in some cases, could be riskier than eating indoors.
As the temperature drops in many parts of the US, restaurants are coming up with creative solutions to allow for outdoor dining. But in some cases, these solutions may increase diners' coronavirus risk.
Since the onset of the pandemic, outdoor dining has allowed restaurants and bars to stay open while offering customers a way to continue eating, drinking, and socializing in a low-risk environment. Outdoor dining has become so popular and lucrative that it's becoming a more permanent fixture everywhere from Milwaukee to Boston. But as we head into the winter months, restaurants will be hard-pressed to convince diners to sit outdoors, exposed to chilly temperatures, wind, and possibly even snow.
Enter: tents, enclosed patios, and even curbside cabanas.
City and state governments across the country seem somewhat split on what types of structures are safe. In Chicago, for example, the city mandates that temporary outdoor structures must have 50% of the sides open in order to ensure air flow. New York City has the same rule, but will allow fully enclosed structures — they'll just be regulated like indoor dining and capped at 25% capacity. Cities in Connecticut and Colorado have similar mandates.
Rest of article - https://www.businessinsider.com/outdoor-dining-tent-safety-risks-explained-2020-11
For one, the thought this is actually outdoor is not necessarily true. Especially as the weather cools, these structures are probably not much different than indoor structures. These areas are essentially four walls and a ceiling and thus there is no advantage providing as would be had by truly being outside.
On top of that, there may be no air circulation thus not providing an escape for potential virus. Or air circulation may not be controlled, resulting in one person's exhaust being blown onto another person.
Sitting in these outside structures may give a person a false sense of security in thinking that they are really outside, so those individuals may be less attentive to the need for social distancing or mask wearing.
Business Insider
https://www.businessinsider.com/outdoor-dining-tent-safety-risks-explained-2020-11
Restaurants are setting up tents and temporary structures to extend outdoor dining during the winter. But they come with their own hazards, and in some cases, could be riskier than eating indoors.
As the temperature drops in many parts of the US, restaurants are coming up with creative solutions to allow for outdoor dining. But in some cases, these solutions may increase diners' coronavirus risk.
Since the onset of the pandemic, outdoor dining has allowed restaurants and bars to stay open while offering customers a way to continue eating, drinking, and socializing in a low-risk environment. Outdoor dining has become so popular and lucrative that it's becoming a more permanent fixture everywhere from Milwaukee to Boston. But as we head into the winter months, restaurants will be hard-pressed to convince diners to sit outdoors, exposed to chilly temperatures, wind, and possibly even snow.
Enter: tents, enclosed patios, and even curbside cabanas.
City and state governments across the country seem somewhat split on what types of structures are safe. In Chicago, for example, the city mandates that temporary outdoor structures must have 50% of the sides open in order to ensure air flow. New York City has the same rule, but will allow fully enclosed structures — they'll just be regulated like indoor dining and capped at 25% capacity. Cities in Connecticut and Colorado have similar mandates.
Rest of article - https://www.businessinsider.com/outdoor-dining-tent-safety-risks-explained-2020-11
Friday, November 13, 2020
This Week in Mislabeled Products for Week Ending November 14, 2020
Wrong Package - Stuffed Foods LLC, a Wilmington, Mass., establishment is recalling approximately 1,818 pounds of snack products due to misbranding and an undeclared allergen - the product contains soy which is not declared on the product label. The problem was discovered after the firm received a customer complaint that a “Mac & Cheese Bite” carton contained “Buffalo Style Chicken Poppers.”
https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2020/recall-026-2020-release
Stuffed Foods LLC Recalls Frozen Snack Products Due to Misbranding and an Undeclared Allergen
Class II Recall
026-2020
Health Risk: Low
https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2020/recall-026-2020-release
Stuffed Foods LLC Recalls Frozen Snack Products Due to Misbranding and an Undeclared Allergen
Class II Recall
026-2020
Health Risk: Low
Nov 11, 2020
FDA Issues Warning Letters to Two Importers for Lack of FSVP
FDA issued Warning Letters to two different companies for FSVP. Neither company had a FSVP in place.
Italfoods, Inc.
MARCS-CMS 610183 — October 27, 2020
- Italfoods, Inc., of South San Francisco, CA did not have it in place for cheese products improted from Italy including Pecorino Toscano DOP Stagionato cheese, your Pecorino Cacio Di Bosco Tartufo Stagio cheese, and your Pecorino Brillo Formaggio cheese. One of the products had been found to have Listeria monocytogenes contamination.
- Handylee USA Corp. of Maspeth, NY did not have FVSP for imported canned corn. canned mushrooms and canned bamboo.
Italfoods, Inc.
MARCS-CMS 610183 — October 27, 2020
FDA Issues Warning Letter on Supply Chain Controls for Cyclospora in Salad Items
FDA issued a Warning Letter to Fresh Express regarding their Illinois processing facility that was linked a the 2020 Cyclospora outbreak. In this outbreak, there were a reported 701 cases in 14 states that were linked to bagged salad mixes containing iceberg lettuce, carrots, and red cabbage. The notice points out that the facility was also involved in a 2018 outbreak that affected over 500 people.
In short, FDA states that the normal supplier controls have not been sufficient, and that the company must do more to control a difficult-to-control pathogen. This is worth a read in how far FDA pushes the idea of Supply Chain Preventive Control.
The FDA first states this product is considered adulterated - "bagged salad mixes are also adulterated within the meaning of section 402(a)(4) [21 U.S.C § 342(a)(4)] in that they have been prepared, packed or held under insanitary conditions whereby they may have been contaminated with filth or whereby they may have been rendered injurious to health."
In the hazard analysis, the facility did have parasites listed as a hazard with the preventive control being a Supply Chain Preventive Control where the facility will "have written procedures which describe your supplier approval of growers and harvesters and your verification of your supply-chain controls, such as food safety record reviews, GFSI third-party audits, second-party audits conducted by Fresh Express, and periodic supplier questionnaires." The facility did do testing, but initially, just to more or less keep an eye on the situation. At the time of the outbreak, the company started to test more product.
FDA essentially points out that product testing is not a good control because it is hard to find this contaminate because it is at such low levels. Rather FDA states that the company needs to ensure the adequate controls by the supplier and doing surveillance of the growing area - "We recommend that you reanalyze your Food Safety Plan to determine whether your preventive controls and grower/harvester verification activities are adequate to ensure control of the hazard of Cyclospora cayetanensis, particularly focusing on potential sources and routes human fecal contamination that would allow partially and fully mature oocysts to contaminate produce in the field before and during harvest. This should include additional focus on handwashing as part of the evaluation for harvesting crew audits, as well as sanitation and cleaning practices for portable toilets, worker health and hygiene, harvest practices, and employee foot traffic through fields, all which may contribute to Cyclospora contamination in the field. In addition, you should consider seasonal environmental surveillance for Cyclospora to determine potential sources of contamination near growing regions where you source your produce."
Next, FDA states that the company needs to enhance traceability - FDA "encourage[s] Fresh Express to improve its traceability systems and processes, thus improving the speed and accuracy by which the company complies with records and information requests from the Agency in the future. Greater expediency on the part of Fresh Express in providing the requested traceback records might have aided in tracing back to potential sources of contamination sooner. Our hope is that improved traceability records on the part of industry will allow the FDA to more quickly and accurately investigate foodborne outbreaks, helping to avoid human illnesses and unnecessary, costly recalls."
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fresh-express-inc-609899-div-chiquita-brands
Fresh Express Inc - Div of Chiquita Brands
MARCS-CMS 609899 — October 20, 2020
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fresh-express-inc-609899-div-chiquita-brands
Fresh Express Inc - Div of Chiquita Brands
MARCS-CMS 609899 — October 20, 2020
Thursday, November 12, 2020
FDA Outbreak Notice of Third E. coli Outbreak Occurring This Fall
FDA issued notice that they are investigating on third E. coli outbreak. The notice goes on to discuss the sample of Romaine lettuce contaminated with E. coli O157:H7. The company in this case had issued a recall the day before this notice was released.
US FDA Outbreak Investigation
https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-e-coli-o157h7-unknown-food-fall-2020
Outbreak Investigation of E. coli O157:H7: Unknown Food (Fall 2020)
This notice is a bit confusing. It reports that there is a third outbreak and states this:
On November 6, 2020, the Michigan Department of Agriculture and Rural Development (MDARD) reported that as a part of routine sampling, they collected a product sample of romaine lettuce for testing. The sample tested positive for E. coli O157:H7 and subsequent whole genome sequencing (WGS) analysis determined that the E. coli O157:H7 present in the samples matches the strain that has caused illnesses in this outbreak.Then the Notice states this:
At this time, there is not enough epidemiologic and traceback evidence to determine if ill people in this outbreak were exposed to romaine lettuce from Tanimura & Antle, Inc. Additional information will be provided as it becomes available.
The notice is a little vague on the outbreak itself, but does provide the CDC information.
From the CDCCase Counts
Total Illnesses: 12
Hospitalizations: 5
Deaths: 0
Last Illness Onset Date: October 14, 2020
States with Cases: CA (2), IL (4), MI (2), OH (1), PA (2), VA (1)
US FDA Outbreak Investigation
https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-e-coli-o157h7-unknown-food-fall-2020
Outbreak Investigation of E. coli O157:H7: Unknown Food (Fall 2020)
Tuesday, November 10, 2020
FDA Issues Draft Guidance on the Voluntary Labeling of Sesame
FDA issued a voluntary Draft Guidance for the labeling of sesame to "encourage manufacturers to clearly declare sesame in the ingredient list, when it is used as a “flavoring” or “spice” or when the common or usual name (such as tahini) does not specify sesame."
Sesame is not currently included in the group of eight major allergens specified in the regulation to be declared in clear terms if included on the label. "The FDA does not have the authority to amend the eight major food allergens established by FALCPA; however, it has the authority under the Federal Food, Drug, and Cosmetic Act to require labeling for other food allergens not covered by the requirements in FALCPA."
This is a draft, so comments can be made by stakeholders.
US FDA Constituent Updates Center for Food Safety and Applied Nutrition
https://www.fda.gov/food/cfsan-constituent-updates/fda-issues-draft-guidance-industry-voluntary-disclosure-sesame-when-added-flavoring-or-spice
FDA Issues Draft Guidance for Industry on Voluntary Disclosure of Sesame When Added as Flavoring or Spice
Constituent Update
November 10, 2020
US FDA Constituent Updates Center for Food Safety and Applied Nutrition
https://www.fda.gov/food/cfsan-constituent-updates/fda-issues-draft-guidance-industry-voluntary-disclosure-sesame-when-added-flavoring-or-spice
FDA Issues Draft Guidance for Industry on Voluntary Disclosure of Sesame When Added as Flavoring or Spice
Constituent Update
November 10, 2020
Monday, November 9, 2020
Romaine Lettuce Recalled After State Laboratory Finds E. coli O157:H7
Tanimura & Antle Inc. is recalling its packaged single head romaine lettuce under the Tanimura & Antle brand, labeled with a packed on date of 10/15/2020 or 10/16/2020, after the State of Michigan test and found a sample with E. Coli 0157:H7. Product was distributed in the United States to the following states: AK, OR, CA, TX, AR, OK, IN, NE, MO, TN, WI, NM, SC, WA, NC, OH, VA, MA, PR, and IL
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/tanimura-antle-voluntary-recalls-packaged-single-head-romaine-lettuce-due-potential-e-coli-0157h7
Tanimura & Antle Voluntary Recalls Packaged Single Head Romaine Lettuce Due to Potential E. Coli 0157:H7 Contamination
Summary
Company Announcement Date: November 06, 2020
FDA Publish Date: November 06, 2020
Product Type: Food & Beverages
Reason for Announcement: Possible contamination with E. Coli 0157:H7
Company Name: Tanimura & Antle Inc.
Brand Name: Tanimura & Antle
Product Description: Single head romaine lettuce
The statement states that this product has not been linked to reported cases of E. coli infection, which would seem to indicate that this product is not liked to the two E. coli outbreaks reported in the last few weeks.
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/tanimura-antle-voluntary-recalls-packaged-single-head-romaine-lettuce-due-potential-e-coli-0157h7
Tanimura & Antle Voluntary Recalls Packaged Single Head Romaine Lettuce Due to Potential E. Coli 0157:H7 Contamination
Summary
Company Announcement Date: November 06, 2020
FDA Publish Date: November 06, 2020
Product Type: Food & Beverages
Reason for Announcement: Possible contamination with E. Coli 0157:H7
Company Name: Tanimura & Antle Inc.
Brand Name: Tanimura & Antle
Product Description: Single head romaine lettuce
Wednesday, November 4, 2020
USDA Issues Warning on Meatballs Potentially Contaminated with Metal Pieces
USDA-FSIS issued a public health alert for heat treated, not fully cooked, not shelf stable, spaghetti and meatballs in marinara sauce products due to concerns that the products may be contaminated with metal pieces. USDA did not issue a recall because they believe that most product is not available to consumers any longer, however it is important for consumer to be aware. The product was from Kwik Trip of La Crosse, WI (Est 20852) and was distributed in WI, IA, and MN.
"The problem was discovered when the firm received consumer complaints reporting findings of metal embedded in meatballs in Kwik Trips, Inc., Spaghetti and Meatball in Marinara Sauce product. There have been no confirmed reports of adverse reactions due to consumption of these products."
https://www.fsis.usda.gov/wps/portal/fsis/newsroom/news-releases-statements-transcripts/news-release-archives-by-year/archive/2020/pha-11042020-01
FSIS Issues Public Health Alert for Spaghetti and Meatballs in Marinara Sauce Products Due to Possible Foreign Matter Contamination
https://www.fsis.usda.gov/wps/portal/fsis/newsroom/news-releases-statements-transcripts/news-release-archives-by-year/archive/2020/pha-11042020-01
FSIS Issues Public Health Alert for Spaghetti and Meatballs in Marinara Sauce Products Due to Possible Foreign Matter Contamination
November 4, 2020
Tuesday, November 3, 2020
VA Creamery Recalls Product Packed in Returnable Glass Bottles With Potential Residual Sanitizer
A Virginia creamery is recalling various products packed in returnable glass bottles after it was discovered that here was an issue with the bottle sanitizing process. According to the notice, "Glass bottled product in question may have a strong sanitizer odor which may affect the taste and quality of the product. There is no known health risk associated with the issue at this time.....The recall was initiated after it was discovered that product smelled like cleaning agent."
Product was shipped to multiple states including Pennsylvania, New York, and Georgia.
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/homestead-creamery-issues-voluntary-glass-bottled-product-recall
Homestead Creamery Issues Voluntary Glass Bottled Product Recall
Summary
Company Announcement Date: October 28, 2020
FDA Publish Date: October 30, 2020
Product Type: Food & Beverages
Reason for Announcement: Potential for residual chlorine from the sanitizing process
Company Name: Homestead Creamery
Brand Name: Homestead Creamery
Product Description: Lemonade half gallon
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/homestead-creamery-issues-voluntary-glass-bottled-product-recall
Homestead Creamery Issues Voluntary Glass Bottled Product Recall
Summary
Company Announcement Date: October 28, 2020
FDA Publish Date: October 30, 2020
Product Type: Food & Beverages
Reason for Announcement: Potential for residual chlorine from the sanitizing process
Company Name: Homestead Creamery
Brand Name: Homestead Creamery
Product Description: Lemonade half gallon
Colorado Market Recall Elderberries After Notification from Supplier
Vitamin Cottage Natural Food Markets, Inc., a Lakewood, Colorado-based natural grocery retailer, is voluntarily recalling Natural Grocers Brand 4-ounce Organic Whole Elderberries after being notified by its supplier of the potential presence of Salmonella. According to the recall notice, "After initially certifying that this product had tested negative for Salmonella and was fit for human consumption, our supplier subsequently notified the company of the potential presence of Salmonella in specific lots of organic elderberries."
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/natural-grocers-issues-voluntary-recall-organic-elderberries-due-potential-presence-salmonella
Natural Grocers Issues Voluntary Recall on Organic Elderberries Due to Potential Presence of Salmonella
Summary
Company Announcement Date: October 29, 2020
FDA Publish Date: November 02, 2020
Product Type: Food & Beverages
Reason for Announcement: Salmonella
Company Name: Vitamin Cottage Natural Food Markets, Inc.
Brand Name: Natural Grocers
Product Description: Organic Whole Elder Berries
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/natural-grocers-issues-voluntary-recall-organic-elderberries-due-potential-presence-salmonella
Natural Grocers Issues Voluntary Recall on Organic Elderberries Due to Potential Presence of Salmonella
Summary
Company Announcement Date: October 29, 2020
FDA Publish Date: November 02, 2020
Product Type: Food & Beverages
Reason for Announcement: Salmonella
Company Name: Vitamin Cottage Natural Food Markets, Inc.
Brand Name: Natural Grocers
Product Description: Organic Whole Elder Berries