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.

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 CDC

Case 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)

FDA Issues Draft Guidance on the Voluntary Labeling of Sesame

FDA issued a voluntary Draft Guidance for the labeling of sesame to "encourage manufacturers to clearly declare sesame in the ingredient list, when it is used as a “flavoring” or “spice” or when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

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

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

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 

November 4, 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

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

CDC - Two Current Outbreaks of E. coli Infection of Unknown Origin

CDC, the FDA and state health and regulatory officials are investigating two different multistate outbreaks of E. coli O157:H7 infections. A specific food item has not yet been identified as the source for either outbreak, although the two separate strains have been involved in past outbreaks including those linked to Romaine lettuce.  There is insufficient evidence at this point, but certainly a focus will be on leafy greens.

Outbreak 1

As of October 28, 2020, a total of 21 people in 8 states are infected with the outbreak strain of E. coli O157:H7.  

• Illnesses started on dates ranging from June 6, 2020, to October 5, 2020.
• There has been one death and other who has HUS.
• This strain was responsible previously in causing outbreaks linked to different sources, including an outbreak linked to romaine lettuce in 2018.

Outbreak 2

As of October 28, 2020, a total of 23 people infected with the outbreak strain of E. coli O157:H7 have been reported from 12 states. 

• Illnesses started on dates ranging from August 17, 2020, to October 8, 2020. 
• Of 15 ill people with information available, 10 hospitalizations have been reported, including 2 people who developed hemolytic uremic syndrome (HUS), a type of kidney failure. 
• No deaths have been reported.
• This outbreak is caused by the same strain of E. coli O157:H7 that caused an outbreak linked to romaine lettuce in 2019.

Outbreak 1.
https://www.cdc.gov/ecoli/2020/o157h7-10-20a/index.html
Outbreak of E. coli Infections in 8 States
Posted on October 28, 2020 at 4:00 PM ET

At A Glance

Reported Cases: 21

States: 8

Hospitalizations: 8

Deaths: 1

California - 7

Florida - 1

Illinois - 1

Michigan - 2

New Jersey - 1

Ohio - 7

Utah- 1

Wisconsin-1

FDA Warning Letters Issued to Three Food Importers for Not Having FSVP for Imported Food Items

FDA issued Warning Letters to three import companies for issues with their FSVP.  The three companies did not have FSVP for the imported food items.

• OCM Group USA Inc. of City of Industry, CA did not develop, maintain, and follow an FSVP for Crushed Chili, imported from (b)(4) and (b)(4) (Sesame), imported from (b)(4).
• FDA conducted a remote Foreign Supplier Verification Program (FSVP) inspection of FSVP records for the firm V-Nine Inc., of Maryland.  The company did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a).imported pad thai sauce.
• Food and Drug Administration conducted a remote Foreign Supplier Verification Program (FSVP) inspection of Aspen Sales Group, of, Bedminster, NJ  as well as an on-site inspection on March 29, 2018.  The company did not develop, maintain or follow a FSVP for fries imported from your foreign supplier, and Refined Sugar imported from your foreign supplier, (b)(4), located in (b)(4)..

FDA Warning Letter - CA Ice Cream Facility Has Inadequate Listeria Control

FDA issued a Warning Letter to a California ice cream company primarily due to inadequate Listeria control.  The FDA "inspection was initiated in response to your firm’s voluntary recall of Peekaboo branded Mint Chocolate Chip with Hidden Spinach Ice Cream (Best Before 10/08/2021), due to findings of Listeria monocytogenes (L. monocytogenes) in the product."

Listeria was found in multiple locations including the bristles of a broom.  The facility also continuously found Listeria during sampling but the corrective actions were not effective.  From the FDA report -  "it appears that your corrective actions were not adequate to address your findings, as evidenced by the recurring findings of Listeria within your environment, including some within the same locations."

This is interesting  - "You identified improper employee handling of boxes of chocolate chips that were transported into the RTE Production Room via dollies and placed on the floor before being added to the (b)(4) machine as the root cause of L. monocytogenes finding in the recalled lot of Peekaboo brand ice cream. Your corrective actions included prohibiting the use of floor dollies on the production floor and replacing them with a (b)(4) cart for transporting and holding inclusions in the RTE Production Room. However, on May 21, 2020, this cart was observed sitting outside the building with one of its wheels in standing ground water. You swabbed this ground surface on May 21, 2020, and the result was positive for Listeria spp. On May 27, 2020, this cart was observed inside the RTE Production Room and you did not have a process for cleaning and sanitizing it when bringing it from the outside into the RTE Production Room."

There were a number of GMP issues including dripping hoses, the bringing in of items from an outside warehouse into an RTE environment, inadequate hand washing station, and improper sanitation of utensils and equipment.

This Week In Mislabeled Products for Week Ending October 30, 2020

Improperly Designed Label Issue - Russ Davis Wholesale of Wadena, Minnesota is recalling individual serving cups of Mixed Veggie Cup with Dip because it may contain undeclared Egg.  The issue was discovered by Quality Control team during a routine label audit, where egg was noted on the dressing ingredient and was not reflected on the finished product label.

More Print and Apply Label Issues - Whole Foods Market is voluntarily recalling select prepared Macaroni & Cheese products from stores across five states because they contain undeclared egg. 

Regular Breaded Halibut Put in Gluten-Free Box - Orca Bay Foods of Seattle, WA is recalling 4,450 lb. (356 cases) of 10 oz. retail box Trader Joe's brand Gluten Free Battered Halibut SKU 00503822, because it contains undeclared wheat and milk allergens.  The recall was initiated after it was discovered that product containing Wheat and Milk was distributed in packaging that did not reveal the presence of the allergens.