FDA Warning Letter - Allergen Recalls Initiates Inspection of Oregon Facility

FDA issued a Warning Letter to Market of Choice, LLC  after inspecting their food manufacturing facility located in Eugene, Oregon.  The inspection was initiated as a result of a Class I recall of one of the company's products because of undeclared tree nut (almond) allergen on the product label printed and applied at the retail stores. 

Allergens

• The company did not appropriately identify undeclared allergens as a hazard requiring a preventive control in allergen-containing products.  Although the facility receives, stores, and uses allergens such as tree nuts, peanuts, milk, eggs, soy, and wheat in production, the hazard analysis indicated that the allergen hazard was not significant due to low likelihood.   [This is a common error that FDA finds...facilities think that the prerequisite programs are sufficient, but FDA is finding that this is not the case].
• The company submitted  a “New Product Label Verification Checklist” , however, this procedure for new product development does not appear to address the root cause of the recall – failure to make electronic allergen labeling revisions after reformulations that add or change the allergens in a product. In addition, the procedure does not include monitoring, corrective action, or verification procedures to ensure control of the undeclared allergen hazard.

 Other items - Of course, if FDA is there, they will conduct a broader inspection.

• The company did not appropriately identify contamination with environmental pathogens, such as Listeria monocytogenes and Salmonella for the RTE fresh salads which are exposed to the environment prior to packaging and do not receive a lethal treatment or otherwise include a control measure that would significantly minimize these environmental pathogens
• The company did not take appropriate Corrective Action  after obtaining "six Salmonella positive swab results in rooms adjacent to the main production room where ready-to-eat products are exposed to the environment prior to packaging.  The company had not established and implemented written corrective action procedures that must be taken to address the presence of an environmental pathogens.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/market-choice-llc-613557-06012021
WARNING LETTER

Market of Choice, LLC
MARCS-CMS 613557 — JUNE 01, 2021
Recipient:
Richard L. Wright Jr.
President
Market of Choice, LLC
2862 Willamette Street, Suite B
Eugene, OR 97405
United States

FDA Issues Report on Salmonella Outbreak Associated with Peaches

FDA issued a report on an August, 2020 outbreak of Salmonella Enteritidis infections linked to 

peaches packed or supplied by a large grower/producer. In total, in the U.S. there were 101 reported 

illnesses across 17 states.

• 'The traceback investigation identified multiple distributors, packing facilities, and orchards that supplied bagged and/or loose peaches during the timeframe of interest to the identified points of service, with a large grower/producer’s peaches and packing facilities supplying the majority of peaches associated with points of service during the timeframe of interest; however, a single point or source of contamination was unable to be determined by the traceback investigation.'
• 'In total, over 700 tests were conducted, including: approximately 180 tests of peach leaves and approximately 20 tests of peaches collected from multiple orchards, approximately 480 tests of environmental samples and approximately 20 tests of peach products collected from three peach packing/holding facilities, and approximately 20 tests of peach products collected from two additional distribution centers (one in Iowa and one in Illinois) for testing. While no test results matched the 2020 outbreak strain, four tests returned positives for Salmonella Alachua and two tests returned positives for Salmonella Montevideo.'
• 'Isolates from one peach test and three leaf tests, each collected from an orchard adjacent to a poultry facility, were positive for Salmonella Alachua.'
• 'Salmonella Montevideo was detected in two tests of orchard canopy leaves collected during this follow-up investigation, each collected from an orchard with adjacent or nearby cattle operations.'
  
• 'We [FDA] hypothesize that the adjacent animal operations (both poultry and cattle) were a likely contributing factor to the Salmonella Enteritidis outbreak – with fugitive dust as one possible route of product contamination. In addition, almond orchards were also identified to be in the vicinity of several identified peach orchards and almond operations have the capacity to generate significant dust due to the nature of their harvesting method in a relatively dry growing environment – as well as having the documented potential to harbor Salmonella populations'

In light of these findings, FDA encourages all farms (including growers, harvesters, etc.) to:

• Be cognizant of and assess risks that may be posed by adjacent and nearby land uses,  especially as it relates to fugitive dust exposure from adjacent or nearby livestock and poultry.
• Assess growing operations to ensure that appropriate science- and risk-based preventive  measures are in place, including applicable provisions of the FDA Food Safety  Modernization Act (FSMA) Produce Safety Rule and good agricultural practices. 
• Consider additional tools such as pre-harvest and/or post-harvest sampling and testing of  products to help inform the risk assessment and clarify the need for specific prevention  measures.
• When pathogens are identified through microbiological surveys, pre-harvest testing of  produce, or post-harvest testing of produce implement industry-led root cause analyses to  determine how the contamination likely occurred and then implement appropriate prevention and verification measures. 
• Improve traceability through increased digitization, interoperability, and standardization of  traceability records which would expedite traceback and help remove contaminated  product from the marketplace more quickly, thereby preventing further illnesses. This is  not only important for growers, but also critical for shippers, manufactures, and retailers as  well, to improve overall traceability throughout the supply chain. 

Personally, the fugitive dust guess is a bit of a stretch considering the number of cases.  There are so many factors that could have played a major role, but would have been impossible for inspectors to see at the time of inspection with time passing and operations changing.

Factors Potentially Contributing to the Contamination of Peaches Implicated in the Summer 2020 Outbreak of Salmonella Enteritidis (fda.gov)
Investigation Report: Factors Potentially Contributing to the Contamination of Peaches Implicated in the Summer 2020 Outbreak of Salmonella Enteritidis

Chick Feed Recalled Due to Deficiently Low Salt Level

Hubbard Feeds is voluntarily recalling EASY FEED ORGANIC CHICK STARTER/GROWER ORG with batch number B01785781. The product has been found to contain deficient levels of salt.   Low sodium may cause abnormal nerve impulses so chicks’ muscles will not move well. Low sodium can also affect the cell’s normal internal pressure which can affect cardiac output due to deflated muscle not working well. The growth of birds may also be negatively impacted.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hubbard-feeds-voluntarily-recalls-easy-feed-organic-chick-startergrower-org
Hubbard Feeds Voluntarily Recalls Easy Feed Organic Chick Starter/Grower Org
Summary
Company Announcement Date:  June 08, 2021
FDA Publish Date: June 08, 2021
Product Type: Animal & Veterinary
Reason for Announcement:  Contains deficient levels of salt
Company Name: Hubbard Feeds
Brand Name: Hubbard Feeds
Product Description: EASY FEED ORGANIC CHICK STARTER/GROWER ORG

Dog Food Recalled After This Deviated Product Inadvertently Is Shipped

Freshpet Inc. is announcing a voluntary recall of a single lot of Freshpet® Select Small Dog Bite Size Beef & Egg Recipe Dog Food (1 LB bags), with Sell by Date 10/30/2021,due to potential contamination with Salmonella. Our Freshpet Team had designated this single lot for destruction, but it was inadvertently shipped to retailers in limited geographic markets between June 7 to June 10, 2021.

These are those types of recalls that occur when 'held' product  inadvertently gets shipped.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/freshpet-voluntarily-recalls-one-lot-freshpetr-select-small-dog-bite-size-beef-egg-recipe-dog-food
Freshpet Voluntarily Recalls One Lot of Freshpet® Select Small Dog Bite Size Beef & Egg Recipe Dog Food Due to Potential Salmonella Contamination
Summary
Company Announcement Date:  June 13, 2021
FDA Publish Date:  June 13, 2021
Product Type:  Animal & Veterinary
Reason for Announcement:  Potential for Salmonella
Company Name:  Freshpet Inc.
Brand Name:  Freshpet
Product Description:  Select Small Dog Bite Size Beef & Egg Recipe Dog Food

Kimchi Aioli Sauce Recalled After Putting Incorrect Back Label on Bottles Resulting in Mislabeled Allergens

Tulkoff Food Products Inc. of Baltimore Maryland is recalling Kimchi Aioli 18 fl. oz. squeeze bottles with lot code 09.18.2021M for the presence of undeclared wheat and soy allergens.  The recall was initiated after Tulkoff discovered that the incorrect back label had been affixed to the product. This error was confined to one specific product, and one specific lot.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/tulkoff-food-products-inc-issues-allergy-alert-undeclared-soy-and-wheat-kimchi-aioli
Tulkoff Food Products, Inc. Issues Allergy Alert on Undeclared (Soy and Wheat) in Kimchi Aioli
Summary
Company Announcement Date:  June 08, 2021
FDA Publish Date:  June 08, 2021
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Soy and Wheat Allergens
Company Name:  Tulkoff Food Products Inc.
Brand Name:  Tulkoff
Product Description:  Kimchi Aioli

Baby Food Manufacturer Recalls Rice Cereal, Decides to Discontinue Product Line

"Beech-Nut Nutrition today has issued a voluntary recall of one lot of Beech-Nut Stage 1, Single Grain Rice Cereal. This recall is a result of a routine sampling program by the State of Alaska which found that samples from that production lot of Beech-Nut Stage 1, Single Grain Rice Cereal tested above the guidance level for naturally occurring inorganic arsenic set by the FDA in August 2020, though the rice flour used had been tested and confirmed as being below the FDA guidance level for inorganic arsenic."

"FDA has recognized that trace elements such as these are widely present in the environment, including water, soil and food; and has also stated that exposure to elevated levels of naturally occurring inorganic arsenic can pose a health hazard to young children."

"In addition to issuing the voluntary recall, Beech-Nut has also decided to exit the market for Beech-Nut branded Single Grain Rice Cereal. Beech-Nut is concerned about the ability to consistently obtain rice flour well-below the FDA guidance level and Beech-Nut specifications for naturally occurring inorganic arsenic."

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/beech-nut-nutrition-company-issues-voluntary-recall-one-lot-beech-nut-single-grain-rice-cereal-and
Beech-Nut Nutrition Company Issues a Voluntary Recall of One Lot of Beech-Nut Single Grain Rice Cereal and Also Decides to Exit the Rice Cereal Segment
Summary
Company Announcement Date:  June 08, 2021
FDA Publish Date:  June 08, 2021
Product Type:  Food & Beverages
Reason for Announcement:  Presence of Inorganic Arsenic above Guidance Levels
Company Name:  Beech-Nut
Brand Name:  Beech-Nut
Product Description:  Stage 1, Single Grain Rice Cereal

Fish Dip Recalled After Using Recalled Smoked Fish Product

Smilin’ Bob’s, a Florida establishment, is voluntarily recalling Smilin’ Bob’s Original Smoked Fish Dip and Smilin’ Bob’s All Natural Smoked Fish Dip after using recalled product from Banner Smoked Fish, Inc. which recalled smoked fish due to possible contamination with Listeria monocytogenes.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/smilin-bobs-voluntarily-recalls-smilin-bobs-smoked-fish-dip-products-because-possible-health-risk
Smilin’ Bob’s Voluntarily Recalls Smilin’ Bob’s Smoked Fish Dip Products Because of Possible Health Risk
Summary
Company Announcement Date:  June 07, 2021
FDA Publish Date:  June 08, 2021
Product Type:  Food & Beverages
Reason for Announcement:  Listeria monocytogenes
Company Name:  Smilin’ Bob’s
Brand Name:  Smilin’ Bob’s
Product Description:  Smoked Fish Dip

Determining the Impact of Cyber Attacks on Food Safety in Light of the JBS Event

An article in Huffington Post (below) discusses the recent cyber attack on JBS, the world's largest meat supplier.  While this resulted in a momentary hold up of the meat supply and not a food safety risk, it does show the vulnerability of a company's digit control system to an attack.

But what if this was impacted the controls for formulation or temperature control, there could be a food safety issue, and certainly a food quality issue.

A white paper titled "Adulterating More Than Food The Cyber Risk to Food Processing and Manufacturing" developed by the Food Protection and Defense Institute (link below) outlines cyber risk and some actions that food companies can take.  One of those actions is to extend your Food Defense and Food Safety programs to address cybersecurity.  

This begins with a risk analysis of the operations involving maintenance and IT staff to understand the involvement of digital control systems within the work flow and then developing practices that would mitigate potential issues.

Huffington Post
What The JBS Meat Hack Means For Consumers, Pricing And Food Safety | HuffPost Life
What The JBS Meat Hack Means For Consumers, Pricing And Food Safety
Will prices go up? Will the meat make us sick? Here's what to know for both the present and the future.
By Heide Brandes
06/04/2021 05:45am EDT

Organic Coriander Recalled After Sampling Finds Salmonella

Olde Thompson LLC. Oxnard, CA in cooperation with the FDA is recalling Olde Thompson and Sun Harvest Organic Ground Coriander in 1.5oz glass jar with flip top closure, Lot # 23632 and 23631 due to possible contamination by Salmonella.  The bacterium was discovered during routine sampling of raw materials.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/olde-thompson-llc-issues-voluntary-recall-olde-thompson-and-sun-harvest-organic-ground-coriander-due
Olde Thompson LLC Issues A Voluntary Recall of Olde Thompson And Sun Harvest Organic Ground Coriander Due to Possible Salmonella Risk
Summary
Company Announcement Date:  June 04, 2021
FDA Publish Date:  June 04, 2021
Product Type:  Food & Beverages
Reason for Announcement:  Potential Salmonella Contamination
Company Name:  Olde Thompson, Sun Harvest
Brand Name:  Olde Thompson, Sun Harvest
Product Description:  Organic Ground Coriander