FDA Issues Reminder to Facilities for Biennial Registration

FDA issued a reminder that U.S. and foreign human and animal food facilities under FDA jurisdiction must renew their registration this year before December 31.

"The FDA will consider the registration of a food facility to be expired if the facility does not renew its registration by December 31, 2020. There is no fee associated with registration or renewal. Owners and operators of food facilities must submit their renewal information electronically through their FDA Industry Systems account, unless they have received a waiver to submit a paper submission."

https://www.fda.gov/food/cfsan-constituent-updates/fda-reminds-human-and-animal-food-facilities-about-years-biennial-registration-renewal-period-and
FDA Reminds Human and Animal Food Facilities About This Year’s Biennial Registration Renewal Period and Provides Updated Guidance on How to Obtain and Submit a DUNS Number

Constituent Update
December 1, 2020

U.S. and foreign human and animal food facilities that are required to register with the U.S. Food and Drug Administration must renew their registration this year before December 31.

This Week in Mislabeled Food Products for November 24, 2020

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?

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

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.  

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

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.

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.

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

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

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 

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.

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.

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