FDA Rolls Out Traceability Rule as Part of FSMA Regulations

FDA released (11/15/22) their latest rule, Food Traceability as a means to allow for faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and/or deaths.  (https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-foods)

Basically, if the food item is on the FTL, the Food Traceability List, there are traceability requirements.

The items that are currently on the list (below) require a Food Traceability Plan (except for those where there is an exemption)

1. A description of the procedures you use to maintain the records you are required to keep under this subpart, including the format and location of these records. 
2. A description of the procedures you use to identify foods on the Food Traceability List that you manufacture, process, pack, or hold; 
3. A description of how you assign traceability lot codes to foods on the Food Traceability List in accordance with § 1.1320, if applicable; 
4. A statement identifying a point of contact for questions regarding your traceability plan and records; and 
5. If you grow or raise a food on the Food Traceability List (other than eggs), a farm map showing the areas in which you grow or raise such foods. 
• Except as specified in paragraph (a)(5)(ii) of this section, the farm map must show the location and name of each field (or other growing area) in which you grow a food on the Food Traceability List, including geographic coordinates and any other information needed to identify the location of each field or growing area.
• For aquaculture farms, the farm map must show the location and name of each container (e.g., pond, pool, tank, cage) in which you raise seafood on the Food Traceability List, including geographic coordinates and any other information needed to identify the location of each container

You must update your traceability plan as needed to ensure that the information provided reflects your current practices and to ensure that you are in compliance with the requirements of this subpart. You must retain your previous traceability plan for 2 years after you update the plan.

Specific records (KDE) must be kept for each Critical Tracking Event (CTE) -  harvesting, cooling, initial packing, shipping, receiving, and transforming the product.

There is more information summarized on the FDA website for what needs to be recorded for each of the steps (below)  However, one can expect that most processors will already have the required tracking systems in place including lot coding.  So the KDEs for the CTL of Transformation (processing).

Transformation KDEs  (Key Data Elements)

FTL food(s) used as ingredient(s)

KDEs must be linked to the new traceability lot for the food

• Traceability lot code for the food

• Product description for the food to which the traceability lot code applies

• For each traceability lot used, the quantity and unit of measure of the food used from that lot

Transformation KDEs for New food produced

KDEs must be linked to the new traceability lot for the food

• New traceability lot code for the food

• Location description for where you transformed the food (i.e., the traceability lot code source), and (if applicable) 

the traceability lot code source reference

• Date transformation was completed

• Product description for the food

• Quantity and unit of measure of the food

• Reference document type and reference document number

So for the the items on the FTL, you will need KDEs for each of the CTLs  (oh brother).

So what items are on the FTL for now. (And items can be added to this list over time by FDA)

FDA Warning Letter Issued to Bakery for Lack of Allergen Preventive Controls

FDA issued a Warning Letter to a Chicago bakery, Third Synthesis Inc., dba Chicago Sweet Connections, Inc..  FDA determined that the ready-to-eat (RTE) cakes and paczkis manufactured in the facility were adulterated within the meaning of the regulation because they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule. 

The facility did not consider allergens a significant hazard within the food safety plan although the "facility receives, stores, and uses allergens such as wheat, milk, egg, soy, and tree nuts (including walnuts, pecans, and coconut) in production." FDA concluded "Therefore, undeclared allergens are a known or reasonably foreseeable hazard. Further, a knowledgeable person manufacturing/processing food in your circumstances would identify undeclared allergens as a hazard requiring a preventive control."  Further, "Furthermore, as mentioned above, FDA investigators observed several types of paczkis and coffee cakes which did not declare allergens, including wheat, milk and/or egg."

Another issue with the Food Safety Plan was not utilizing a Sanitation Preventive Control for pathogens in post-process environment.  The report also criticizes the plan development for not identifying mycotoxins as a hazard in the hazard analysis.

There were also a number of label design issues that resulted in a number of products being mislabeled.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/third-synthesis-inc-dba-chicago-sweet-connections-inc-633453-09062022
Third Synthesis Inc., dba Chicago Sweet Connections, Inc.
MARCS-CMS 633453 — SEPTEMBER 06, 2022

Recipient:
Anthanasios Kailis
President/CEO/Owner
Third Synthesis Inc., dba Chicago Sweet Connections, Inc.
5569 N. Northwest Highway
Chicago, IL 60630
United States

The Importance of Reanalysis of the Food Safety Plan

An article in Food Safety Magazine discusses the importance of conducting the reanalysis of the food safety plan.  For many organizations, the reanalysis process is put off until the time it is required to be completed.  Rather, it should be an active process that is ongoing with specific triggers, including process change or failure, complaint data, or industry developments.

https://www.food-safety.com/articles/8051-reanalysisa-critical-component-of-verification
Reanalysis—A Critical Component of Verification

The Food Safety Plan/HACCP Plan is a living document that requires ongoing maintenance, including reanalysis at appropriate time intervals

CDC Investigating a Listeria Outbreak Linked to Deli meat and Cheese

CDC is investigating an Outbreak of Listeria linked to deli meat and cheese. There have been 16 illnesses and 1 death from 6 states, with NY showing the highest level (7 cases).  " Sick people range in age from 38 to 92 years, with a median age of 74, and 62% are male. Of 13 people with ethnicity information available, 11 are of Eastern European background or speak Russian. Of 14 people with information available, 13 have been hospitalized, including one Maryland resident who died. One person got sick during their pregnancy, resulting in pregnancy loss."

"In 2021, health officials in New York state and New York City found the outbreak strain of Listeria in several environmental and food samples: 1) Environmental samples from a NetCost Market deli in Brooklyn, 2)Several open packages of mortadella and ham that were sliced at the same NetCost Market deli in Brooklyn and 3) Sliced salami that a sick person bought from a NetCost Market deli in Staten Island.  In September 2022, the outbreak strain was found at the same Brooklyn NetCost Market deli; however, the most recent illness with NetCost Market exposure was in October 2021. After a deep cleaning, additional environmental testing did not identify Listeria in the deli."

https://www.cdc.gov/listeria/outbreaks/deli-11-22/index.html
Listeria Outbreak Linked to Deli Meat and Cheese
Fast Facts
Illnesses: 16
Hospitalizations: 13
Deaths: 1
States: 6
Recall: No

Non-Federally-Inspected CA Establishment Recalls Beef Dumplings

Menu19 LLC, a Modesto, Calif. establishment, is recalling approximately 5,001 pounds of frozen beef dumpling products that were produced without the benefit of federal inspection. The product subject to recall does not bear the USDA mark of inspection because Menu19 LLC is not a federally inspected establishment. These items were shipped to restaurants and retail locations in California. The problem was discovered during routine FSIS surveillance activities in retail stores when it was determined that the Mantu beef dumpling products did not have the USDA mark of inspection and were produced in an establishment that was not inspected by USDA.

https://www.fsis.usda.gov/recalls-alerts/menu19-llc-recalls-frozen-beef-dumpling-products-produced-without-benefit-inspection
Menu19 LLC Recalls Frozen Beef Dumpling Products Produced Without Benefit of Inspection

FSIS Announcement

WASHINGTON, Nov. 9, 2022 - Menu19 LLC, a Modesto, Calif. establishment, is recalling approximately 5,001 pounds of frozen beef dumpling products that were produced without the benefit of federal inspection, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today.

IA Company Recalls Granola Product Due to Undeclared Milk

Big Sky Bread Company of Urbandale, IA is recalling their Big Sky Chocolate Chunk Granola and Big Sky Chocolate Chunk Peanut Butter Chip Granola because it may contain undeclared milk.  The recall was initiated after it was discovered during a routine inspection that a product containing milk was distributed in packaging that did not reveal the presence of milk.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/big-sky-bread-company-issues-allergy-alert-undeclared-milk-chocolate-chunk-granola-and-chocolate
Big Sky Bread Company Issues Allergy Alert on Undeclared Milk in Chocolate Chunk Granola and Chocolate Chunk Peanut Butter Chip Granola
Summary 
Company Announcement Date:  November 09, 2022
FDA Publish Date:  November 14, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared milk
Company Name:  Big Sky Bread Company
Brand Name:  Big Sky Bread Company
Product Description:  Chocolate Chunk Granola and Chocolate Chunk Peanut Butter Chip Granola

Whole Food Supplier Recalls Crumb Cakes Due to Undeclared Pecans

BOSTON BAKING, Inc. of Boston, MA, is recalling its 3-ounce, individually wrapped packages "Boston Baking Mini Cinnamon Crumb Cakes" food snacks sold exclusively at Whole Foods Market stores because they may contain undeclared pecans.  The recall was initiated after it was discovered by Whole Foods Market team member that the pecan-containing product was distributed in packaging that did not include pecans in the ingredient list. Subsequent investigation indicates the problem was caused by an isolated error in the company's production and packaging processes.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/boston-baking-issues-allergy-alert-undeclared-pecans-boston-baking-mini-cinnamon-crumb-cakes
Boston Baking Issues Allergy Alert on Undeclared Pecans in "Boston Baking Mini Cinnamon Crumb Cakes"
Summary
Company Announcement Date:  November 14, 2022
FDA Publish Date:  November 14, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared pecans
Company Name:  Boston Baking, Inc.
Brand Name:  Boston Baking
Product Description:  Mini Cinnamon Crumb Cake

RTE Smoked Salmon Recalled After Sample Tests Positive for Listeria

Seven Seas International USA, LLC of St. Petersburg, Florida is voluntarily recalling 540 cases of Giant Food Private Label Sockeye Smoked Salmon, because it has the potential to be contaminated with Listeria monocytogenes.  The product was distributed by Giant Food in Maryland, Virginia, Washington D.C. and Delaware.  The issue was discovered through routine regulatory testing conducted by the Maryland Department of Health.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/seven-seas-international-usa-llc-voluntarily-recalls-giant-food-private-label-wild-caught-alaskan
Seven Seas International USA, LLC Voluntarily Recalls Giant Food Private Label Wild Caught Alaskan Sockeye Smoked Salmon Because of Possible Health Risk
Summary
Company Announcement Date:  November 08, 2022
FDA Publish Date:  November 08, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Potential Listeria monocytogenes contamination
Company Name:  Seven Seas International USA, LLC
Brand Name:  Giant
Product Description:  Smoked Salmon

Marshmallow Cookies Recalled After Routine Sampling Finds Salmonella Positive Sample

Comercializadora PepsiCo S. de R.L. de C.V. today issued a voluntary recall for 15.5 oz, 6 count box of Gamesa Arcoiris Marshmallow Cookies due to the potential presence of Salmonella.  The recall was initiated as the result of a routine sampling program by the company, which revealed the finished product may contain Salmonella.  The company initiated the voluntary recall on the product below out of a commitment to and concern for consumers. The product covered by this recall was distributed to warehouses in California and Texas and may have reached consumers through select retail stores.  No illnesses related to Salmonella have been confirmed to date.

Recalls like this are the reason why you need to make sure your laboratory is doing a good job by having controls in place to ensure accuracy of testing.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/comercializadora-pepsico-s-de-rl-de-cv-issues-voluntary-recall-gamesar-arcoiris-marshmallow-cookies
Comercializadora PepsiCo S. de R.L. de C.V. Issues Voluntary Recall of Gamesa® Arcoiris Marshmallow Cookies Due to Possible Health Risk
Summary
Company Announcement Date:  November 07, 2022
FDA Publish Date:  November 07, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Potential presence of Salmonella
Company Name:  Comercializadora PepsiCo S. de R.L. de C.V.
Brand Name:  Gamesa
Product Description:  Arcoiris Marshmallow Cookies