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.

CDC Outbreak Notice - Listeria in Unidentified Deli Meat Linked to 10 Cases of Listeria with One Death

The CDC issues a notification of an ongoing outbreak of Listeria that has been linked to Italian style deli meat.  "As of October 22, 2020, a total of 10 people infected with the outbreak strain of Listeria monocytogenes have been reported from three states", Florida, Massachusetts, and New York, with those cases occurring from August thru October.  Deli meat were reported as both pre-packaged and deli-sliced.

CDC Outbreak Notice
https://www.cdc.gov/listeria/outbreaks/delimeat-10-20/index.html
Outbreak of Listeria Infections Linked to Deli Meats
Posted October 23, 2020 at 4:45 PM ET

At A Glance
Reported Cases: 10
States: 3
Hospitalizations: 10
Deaths: 1

Latest Outbreak Information

• 10 people infected with the outbreak strain of Listeria have been reported from Florida, Massachusetts, and New York.
• All 10 ill people were hospitalized. One death has been reported from Florida.
• Epidemiologic evidence shows that deli meat is a likely source of this outbreak.
• In interviews with 9 ill people, all reported eating Italian-style meats, such as salami, mortadella, and prosciutto. They reported purchasing prepackaged deli meats and meats sliced at deli counters at various locations.
• A specific type of deli meat and common supplier have not yet been identified.

China - Nine People Dead After Consuming Noodles Made From Fermented Corn Flour Contaminated with Toxin from Burkholderia gladiol

In China, nine people died after eating noodles made from contaminated corn flour. The flour was found to contain the toxin bongkrekic acid which is produced by bacterium Burkholderia gladioli.

Bongkrekic acid, or BA, is a highly toxic compound that inhibits the enzyme ADP/ATP translocase, the enzyme that exchanges ATP and ADP across the mitochondrial membrane. The toxin is preformed in the food. It is said to be an issue in fermented coconut fiber and corn flour. "Bongkrekic acid production depends on two distinct and sequential environmental conditions: those that support bacterial growth and proliferation, followed by those that favor BA production .Bongkrekic acid is produced in warm environments (22–30 °C) with a neutral pH, the same conditions under which tempe is made. Production is also dependent on the presence of fatty acids, particularly those found in coconut and corn"

A similar foodborne illness outbreak occurred in 2015 in Mozambique when after consuming pombe, a traditional alcoholic beverage product, during a funeral event, 230 became sick and 75 died, In this case, the provider of the pombe used corn flour that had previously gotten wet.

Newsweek
https://www.newsweek.com/family-members-die-homemade-noodles-1541320?amp=1
9 Family Members Die After Eating Year-Old Homemade Noodles

Imported Mini Jelly Cups Recalled Due to the Potential as a Choking Hazard

Two NY importing companies are recalling bags of mini jelly cup products due to the fact the product represents a choking hazard, especially for children.  While there have been no reported cases of choking, the product parameters indicate it can be an issue.

The Consumer Product Safety Commission has established standards for what represents a choking hazard.  https://www.cpsc.gov/Business--Manufacturing/Business-Education/Business-Guidance/Small-Parts-for-Toys-and-Childrens-Products/








https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hadson-toko-trading-co-inc-recalls-eishindo-mini-cup-jelly-50pcs-because-potential-choking-hazard
Hadson Toko Trading Co., Inc. Recalls Eishindo Mini Cup Jelly (50pcs) Because of Potential Choking Hazard
Summary
Company Announcement Date: October 14, 2020
FDA Publish Date:  October 14, 2020
Product Type:  Food & Beverages
Reason for Announcement:  Product poses a choking hazard.
Company Name:  Hadson Toko Trading Co., Inc.
Brand Name:  Eishindo
Product Description:  Jelly Cups

Organic Parsley Product Recalled After Testing Finds Salmonella in Same Lot

Red Monkey Foods, Inc. is recalling select organic parsley and another product made with this parsley after a recall was issued by its supplier, High Quality Organics (HQO). HQO issued a recall for this lot of parsley after another customer tested and found Salmonella in a portion of this same lot. 

The product was shipped nation wide under Cost Plus , Great Value, O Organics and Full Circle.  There have been no reported illnesses.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/red-monkey-foods-inc-recalls-parsley-and-herbes-de-provence-because-possible-health-risk
Red Monkey Foods, Inc. Recalls Parsley and Herbes De Provence Because of Possible Health Risk
Summary
Company Announcement Date:  October 13, 2020
FDA Publish Date:  October 13, 2020
Product Type:  Food & Beverages
Reason for Announcement:  Salmonella
Company Name:  Red Monkey Foods, Inc.
Brand Name:  Cost Plus World Market, Great Value, O Organics, Full Circle
Product Description:  Parsley and Herbes De Provence

Research Study - Prevalence of Listeria in Frozen Produce in England

A study out of the UK looked at the prevalence of Listeria monocytogenes in frozen fruits and vegetables sold at retail. Of the 1050 samples tested, "There were 78 samples (7%) from which L. monocytogenes was detected and 101 (10%) from which other Listeria species were detected. Neither L. monocytogenes nor other Listeria species were detected at levels of >100 cfu/g in any samples."

While these samples would be acceptable in the EU because the levels are not greater than 100 cfu/gm, these products would be not be acceptable in the US. Cooking would eliminate the pathogen, but the risk would arise if these items were used in a ready-to-eat application, and through preparation and storage, the organism was able to grow to higher levels.

This demonstrates the importance of control of Listeria in these types of operations. From a consumer perspective, there is the importance of following label instructions which normally requires cooking.

International Journal of Food Microbiology
https://www.sciencedirect.com/science/article/pii/S0168160520303433
Occurrence of Listeria and Escherichia coli in frozen fruit and vegetables collected from retail and catering premises in England 2018–2019

Outbreak Investigation Update - Salmonella in Red Onions - October 2020

FDA issued an update on the Salmonella outbreak associated with red onions which was first identified in July when Canadian authorities issued notice.  In the US, there were 1,127 cases with 167 hospitalizations.  The onions originated from Thompson International, which issued a recall, and that recall spurned other recalls where the onions were used in various other products.

At this point, CDC is saying that that outbreak appears over.  While FDA identified Thompson International as the source, FDA had not been able to identify any definitive reason for the contamination. 

 "FDA has completed over 2000 product and environmental analyses from multiple Thomson International Inc. locations and surrounding areas, including water, soil, and scat samples. Although a variety of genetic strains of Salmonella Newport have been detected, as well as multiple other Salmonella serotypes, a genetic match to the outbreak strain has yet to be identified in any of the samples collected. Additional sample analysis is underway. Although the outbreak is being declared over, the FDA will continue its root cause investigation and will communicate any findings that could assist future prevention efforts. "

FDA Outbreak Investigation
https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-salmonella-newport-red-onions-july-2020
Outbreak Investigation of Salmonella Newport: Red Onions (July 2020)
CDC announces the end of the outbreak; FDA continues its investigation.

Case Counts
Total Illnesses: 1,127
Hospitalizations: 167
Deaths: 0
Last illness Onset Date: September 11, 2020
States with Cases: AK (25), AL (2), AZ (39), AR (2), CA (128), CO (32), CT (2), DE (2), FL (8), GA (11), HI (3), ID (43), IL (54), IN (4), IA (31), KS (3), KY (3), ME (6), MD (7), MA (2), MI (47), MN (19), MS (5), MO (11), MT (72), NE (10), NV (11), NH (1), NJ (12), NM (3), NY (14), NC (6), ND (9), OH (11), OK (1), OR (109), PA (27), RI (3), SC (1), SD (23), TN (7), TX (2), UT (115), VA (10), WA (150), WV (3), WI (11), WY (27)

FDA Warning Letter - Inadequate Allergen Controls at Salad Kit Company

A California salad processor was issued a Warning Letter by FDA for not have an Allergen Preventive Control at the masterpack addition step (the point in the process where the add the packets of salad add-ons....like dressing, nuts, etc. In the case that required a recall, “[t]he incorrect masterpack (kit with dressing and other toppings) was unintentionally used during the production of the [Tuscan Herb Chopped Salad Kit,]” "The masterpack used held dressing that contained peanut butter and almond, cashew, and chow mein noodle (wheat) toppings" Not items that would be added to a Tuscan Herb Chopped Salad. The firm "indicated that the cause was that [the company] “did not have a robust enough verification process for product changeover.”

So FDA issued a Warning Letter for not identifying and implementing food allergen controls adequate to significantly minimize or prevent the hazard of undeclared allergens as evidenced by [the] firm using an incorrect masterpack in your Tuscan Herb Chopped Salad Kit. This masterpack addition error caused {the] product to contain undeclared major food allergens."


FDA Warning Letter

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dole-fresh-vegetables-inc-608414-09252020

Dole Fresh Vegetables, Inc. 

MARCS-CMS 608414 — September 25, 2020 

FDA Warning Letter - Inadequate Allergen Controls at Chip Factory

An Indiana potato chip manufacturer was issued a Warning Letter as part of an inspection in response to a recall.  The recall was issued "after being notified by consumers that cheddar cheese flavored chips were found in bags of Kroger brand Sweet & Mesquite BBQ Flavored Potato Chips"

The company was cited for having an inadequate Food Safety plan, specifically, the company "did not identify and implement food allergen controls at the seasoning step adequate to significantly minimize or prevent the hazard of undeclared allergens as evidenced by [the] firm using cheddar and sour cream flavored seasoning instead of barbecue flavored seasoning while producing Sweet & Mesquite BBQ Flavored Potato Chips".  

Basically, there was no substantial control to make sure the flavor added to the product matched the label on the bag in which the finished chips were packed.  A pretty easy preventive control to implement, and perhaps one the company did not see as necessary because a simple control had worked in the past.  Not this time.  A simple error could have been easily been avoided by raising this to the level of a preventive control.

FDA Warning Letter

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/saratoga-potato-chips-llc-608017-09242020

Saratoga Potato Chips LLC
MARCS-CMS 608017 — September 24, 2020 

Intentional Contamination - Man Arrested for Putting Razor Blades in Pizza Dough

In Maine, a 38 man was arrested for putting razor blades in pizza dough sold at the supermarket.  The man was a former employee of the company which makes the dough.  

The razor blades were discovered by a customer who purchased the product.  The supermarket reviewed surveillance video and were able to identify the suspect.  "Authorities immediately released a physical description of Mitchell as well as a description of his car in an appeal to the public to help them track down the suspect as quickly as possible. They were able to arrest him within about two hours approximately 50 miles away in Dover, New Hampshire, according to a separate police statement announcing his arrest."

ABC News
https://abcnews.go.com/US/man-arrested-stuffing-razor-blades-consumers-pizza-dough/story?id=73559166
Man arrested for stuffing razor blades into consumers' pizza dough
The supermarket chain has now issued a full product recall.
ByJon Haworth
October 12, 2020, 6:20 AM

A man has been arrested after he was reportedly caught putting razor blades into pizza dough that was then sold to customers, according to the Saco Police Department in Maine.

Recent Studies Renew Call for Sanitizing Surfaces and Handwashing to Control COVID-19 Virus

Two recently published studies demonstrated that the COVID-19 virus can survive on surfaces for long periods of time.  An Australian study found that with "initial viral loads broadly equivalent to the highest titres excreted by infectious patients, viable virus was isolated for up to 28 days at 20 °C from common surfaces such as glass, stainless steel and both paper and polymer banknotes."  A study out of Japan found that the virus can survive on the skin up to 9 hours.

Certainly aerosolized virus is the primary route of infection.  But as these studies show, contact transmission, such as when the SARS-CoV-2 is on surfaces or on the hands, must be considered.  So with this, surface sanitizing and handwashing must be routinely done.  

The focus for many people has been on mask wearing, but there must be renewed attention to sanitizing surfaces including the hands.  My retail operations have reduced their support for this through not having hand sanitizer or sanitizing wipes available.  This needs to improve.

Virology Journal
https://link.springer.com/epdf/10.1186/s12985-020-01418-7

The effect oftemperature onpersistence ofSARS-CoV-2 oncommon surfaces

Abstract Background: The rate at which COVID-19 has spread throughout the globe has been alarming. While the role of fomite transmission is not yet fully understood, precise data on the environmental stability of SARS-CoV-2 is required to determine the risks of fomite transmission from contaminated surfaces. 

This Week in Mislabeled Products for Week Ending October 10, 2020

Peanut Butter Cookies Packaged as Wheat Crackers - B&G Foods is recalling a very limited number of boxes of a single date code of 6 oz. Back to Nature Organic Rosemary & Olive Oil Stoneground Wheat Crackers, with a “best by” date of APR 25 2021, after learning that a very limited number of the cracker boxes were inadvertently filled with foil wrapped pouches of peanut butter cookies.  B&G Foods discovered this issue when it received consumer complaints that the foil bags within two boxes of Back to Nature Organic Rosemary & Olive Oil Stoneground Wheat Crackers contained peanut butter cookies. The foil bags do correctly indicate whether the product contains rosemary & olive oil crackers or peanut butter cookies.

Company Recalls Spice Items After Notification by Ingredient Supplier of Potential Salmonella Risk

Sauer Brands, Inc. is  recalling a number of its The Spice Hunter Products due to the potential for  Salmonella. The Salmonella was associated with lots of parsley were used on two specific days in production.   The company states that after initially certifying that the raw material had tested negative for Salmonella, the parsley supplier notified the company that specific lots of organic parsley had the the potential to be contaminated with Salmonella.  The company then went and recalled other products produced on those same days out of an abundance of caution regarding potential cross contamination.  

This supplier issue forced the company to evaluate its other products that were produced at the same time as when they handled the potentially contaminated ingredient.  Generally once spices are cleared through testing, they should be good to go.  But what happens when your supplier then calls and says that there may be an issue with one of those approved lots of spice?

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sauer-brands-inc-voluntarily-recalls-certain-spice-hunter-products-because-potential-salmonella
Sauer Brands, Inc. Voluntarily Recalls Certain The Spice Hunter Products Because of Potential Salmonella Contamination
Summary
Company Announcement Date: October 12, 2020
FDA Publish Date:  October 12, 2020
Product Type:  Food & Beverages
Reason for Announcement:  Salmonella
Company Name:  Sauer Brands, Inc.
Brand Name:  The Spice Hunter
Product Description:  Spices and blends 

Pet Food Company Expands Recall of Pet Food Due to Aflatoxin

Sunshine Mills, Inc. is expanding its September 2 recall of certain pet food products after an FDA investigation determined that additional corn-based products may also contain aflatoxin.  These products were made with corn ingredient that contained Aflatoxin at levels above FDA’s action levels. The product was produced between April 3, 2020 and April 5, 2020 may contain corn from a single load of corn with elevated levels of aflatoxin. 

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sunshine-mills-inc-expands-previously-announced-voluntary-recall-certain-pet-food-products-due
Sunshine Mills, Inc. Expands Previously Announced Voluntary Recall of Certain Pet Food Products Due to Potentially Elevated Levels of Aflatoxin
Summary
Company Announcement Date:  October 08, 2020
FDA Publish Date:  October 08, 2020
Product Type:  Animal & Veterinary
Food & Beverages   Pet Food  
Reason for Announcement:  May Contain Aflatoxin
Company Name:  Sunshine Mills, Inc.
Brand Name:  Champ, Field Trial, Good Dog, and Others
Product Description:  Pet Food

Whole and Cut Cantaloupe Recalled for Potential Salmonella Contamination Discovered Through State Testing

Meijer, in conjunction with Eagle Produce, LLC in Aguila, AZ., is recalling of whole cantaloupe and select cut cantaloupe fruit trays and bowls due to the potential risk of Salmonella after sampling by the Michigan Department of Agriculture and Rural Development.  There have been no reported illnesses.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/meijer-recalls-whole-cantaloupes-and-select-cut-cantaloupe-trays-due-potential-health-risk
Meijer Recalls Whole Cantaloupes and Select Cut Cantaloupe Trays Due to Potential Health Risk
Summary
Company Announcement Date:  October 07, 2020
FDA Publish Date:  October 07, 2020
Product Type:  Food & Beverages   Fruit/Fruit Product
Reason for Announcement:  Salmonella
Company Name:  Meijer
Brand Name:  Kandy Brand, Meijer Brand
Product Description:  Whole Cantaloupe, Select Cut Cantaloupe Fruit Trays & Bowls

Cinnamon Apple Chips Recalled Due to Potential for Salmonella Contamination in Spice

Seneca Snack Company, a Washington Corporation, is recalling its Seneca Cinnamon Apple Chips and Clancy’s Cinnamon Apple Chips after a supplier notified them that a lot of cinnamon ingredient had the potential to be contaminated with Salmonella.   This only affects Clancy’s product sold by ALDI and Seneca products sold nationwide through Amazon and Gemline.  There have been no know reported cases of illness.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/seneca-recalls-cinnamon-apple-chips-because-possible-health-risk
Seneca Recalls Cinnamon Apple Chips Because of Possible Health Risk
Summary
Company Announcement Date:  October 02, 2020
FDA Publish Date:  October 05, 2020
Product Type:  Food & Beverages
Reason for Announcement:  Possible Salmonella contamination
Company Name:  Seneca Snack Company
Brand Name:  Seneca, Clancy’s
Product Description:  Seneca Cinnamon Apple Chips and Clancy’s Cinnamon Apple Chips

Produce Company Expands Listeria-linked Recall

Country Fresh is extending the recall they issued last week to include various containers of fresh cut and/or sliced apples, grapes, mangos, pineapples and cantaloupe distributed by Walmart.  As is often the case with recalls involving Listeria, the recall is expanded when there are no clean lines to separate the initial lot of product recalled from other lots of the same product or different products.  Products processed in the same facility, whether that is on the same equipment or in the same area are also potentially exposed to the same contamination point.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/country-fresh-expands-voluntary-recall
Country Fresh Expands Voluntary Recall
Summary
Company Announcement Date: October 03, 2020
FDA Publish Date:  October 03, 2020
Product Type:  Food & Beverages
Reason for Announcement:  Potential to be contaminated with Listeria monocytogenes
Company Name:  Country Fresh
Brand Name:  Walmart
Product Description:  Cut or sliced apples, grapes, mangoes, pineapples, and cantaloupe

FDA Releases Proposed Traceability Regulation

As part of the FSMA requirements (FSMA 204(s)(1), FDA is establishing record keeping requirements for certain foods. While there are existing requirements for lot tracking – the requirement to know the immediate source and immediate recipient, or one-up, one back – these FSMA related requirements add to that, specifically for foods the agency has designated as high-risk human foods.

• The rule only applies to certain food items that are on the list, although FDA would hope that companies would adopt these practices industry wide.  Currently, the list includes:

1. Cheese, other than hard cheese
2. Shell eggs
3. Nut butter
4. Cucumbers
5. Fresh herbs
6. Leafy greens
7. Melons
8. Peppers
9. Sprouts
10. Tomatoes
11. Tropical tree fruits
12. Fresh-cut fruits and vegetables
13. Finfish and smoked finfish
14. Crustaceans
15. Mollusks
16. RTE deli salads

• The rule applies to all entitles that manufacture, process, pack, or hold foods that appear on the Food Traceability List. The proposed rule has exemption for small farms, processed produce, food transporters
• Although the rule does not state that an electronic record is required, it does state that the entity must produce records within 24 hours of FDA request.
• It applies to the specific foods/ingredients including when those high risk foods are used in making other foods (unless those foods are thermally processed.)
• Lot numbers must be applied to those ingredients. When product is shipped to another entity, the lot information must be conveyed including description and quantity of product. The rule establishes KDEs, Key Data Elements associated with Critical Tracking Events (CTEs). Basically, important points along the supply chain must keep certain kinds of information. Critical tracking event (CTE) are events in the supply chain of that food involving the growing, receiving (including receipt by a first receiver), transforming, creating, or shipping of the food. (Creating is different than transforming).
• Those entities receiving product, including retailers, would need to capture that information on a record such as a bill of lading and match it to any outbound records.
• A distributor who receives these high risk food items would have to be able to link, by lot number, a product in inventory with the immediate previous source of the food, the location, date and time the food was received, and the quantity and unit of measure of the food received.

This will require some further study to find pitfalls, if any.  Really hate to see the creation of additional jargon and all of the areas that can be open for interpretation on who needs to keep what information. 

Cleary much of this falls onto the produce industry, where even a highly sophisticated system may not be able to circumvent all issues faced during an outbreak investigation.  However, standardizing the basics such as uniform lot code usage, capture, and tracking  would certainly be a good start.

https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-proposed-rule-food-traceability

FSMA Proposed Rule for Food Traceability

9/21/29

This Week in Mislabeled Products Thru October 3, 2020

Mislabeled Pecan Containing Ice Cream - Homestead Creamery of Wirtz, VA is recalling one lot of Homestead Creamery chocolate ice cream quarts, dated 5/13/2021, because it may contain undeclared pecans.   The recall was initiated after it was discovered that product containing the pecans may have been distributed in packaging that did not reveal the presence of pecans.

Mislabeled Salad Dressing - GHSW, LLC. is voluntarily recalling 1512 units of Trader Joe’s Southwest Style Sweet Potato Sauté Bowl due to undeclared milk and egg allergens in the dressing that are not declared on the label.  The recall was initiated after it was discovered that the dressing containing milk and egg was distributed in packaging that did not declare the presence of milk or egg.

Mislabeled Chicken Salad Contains Walnuts Not on Label  - Willow Tree Poultry Farm, Inc., an Attleboro, Mass. establishment is recalling approximately 6,890 pounds of ready-to-eat (RTE) chicken salad products due to undeclared walnuts, a known allergen, which are not declared on the product labels. The RTE chicken salad product labeled as “Classic Chicken Salad” may actually contain “White Meat Cranberry Walnut Chicken Salad” 

Watermelon Chunks Recalled After FDA Finds Listeria on Packing Equipment

Country Fresh is recalling watermelon chunks sold at Walmart and RaceTrac in several southcentral states after FDA found Listeria on packaging equipment.  The testing was conducted as part of an inspection.  There have been no illness reported to date.

Processors of fresh cut produce must have tight controls on Listeria in the processing environment.  At this point, this facility will need to detail clean its operation and conduct a root cause analysis on how the organism was able to get onto the equipment.  We may see additional products recalled after further investigation by FDA.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/country-fresh-voluntary-product-recall
Country Fresh Voluntary Product Recall
Summary
Company Announcement Date: October 01, 2020
FDA Publish Date: October 01, 2020
Product Type:  Food & Beverages
Reason for Announcement:  Potential to be contaminated with Listeria monocytogenes
Company Name:  Country Fresh
Brand Name:  Walmart  RaceTrac
Product Description:  Watermelon Chunks

FDA Testing of Dark Chocolate Products for Milk Allergens - Verifying the Absence Claims

Dark chocolate should be free from milk, especially when labeled as dairy free.  But can a person with milk allergies count on that?  FDA conducted analysis of 119 samples representing 52 products -  all products being manufactured in the U.S.  bearing a dairy-free or similar claim[ on their package or website, and consisting solely of dark chocolate (e.g., be free of cream or nougat filling, a candy shell, or inclusions such as nuts, fruit, or seeds).  Samples were collected from 2018 to 2019.

"The FDA determined that four of the 52 products tested had potentially hazardous levels of milk allergen. These four products – all dark chocolate bars – were made by three different manufacturers. Together the four products were responsible for 12 positives out of the 119 samples....The agency found the 12 samples from the four products to have milk allergen levels ranging from 600 ppm to 3,100 ppm. The agency determined that, at these levels, the four products held the potential to cause severe reactions in consumers with milk allergy. The FDA took action as warranted to address each of these positives."

"The FDA does not define the terms “dairy free,” “milk free” or other “absence” claims, except for “gluten free.” Absence claims are voluntary statements that indicate a specific ingredient or food component is not present in a product.  Absence claims, when used, must be truthful and not misleading, per the Federal Food, Drug and Cosmetic Act.  If a product or references to a product on a company website were to bear a dairy-free or similar claim, the FDA would expect there to be no milk allergen in the product given that consumers with milk allergy depend on the accuracy of dairy-free claims for their health. The presence of milk allergen in a product bearing a dairy-free claim may lead the agency to conduct an investigation and to consider enforcement action, depending on the investigational findings."

https://www.fda.gov/food/sampling-protect-food-supply/fy1819-sample-collection-and-analysis-domestically-manufactured-dairy-free-dark-chocolate-products
FY18/19 Sample Collection and Analysis of Domestically Manufactured, Dairy-Free Dark Chocolate Products for Milk Allergen