Imported Pasta Recalled for Undeclared Wheat

World Variety Produce, Inc. is recalling Melissa’s Pasta Para Duros due to undeclared wheat. The product was imported from Mexico.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/world-variety-produce-inc-voluntarily-recalls-melissas-pasta-para-duros-12oz-because-it-contains
World Variety Produce, Inc. Voluntarily Recalls Melissa’s Pasta Para Duros 12oz Because it Contains Undeclared Wheat Allergens
Summary
Company Announcement Date:  December 23, 2022
FDA Publish Date:  December 23, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Wheat
Company Name:  World Variety Produce, Inc.
Brand Name:  Melissa’s
Product Description:  Pasta Para Duros

Oat-based Yogurt Alternative Recalled for Almond Allergen Due to Mislabeling Issue

Culture Fresh Foods is issuing a recall for True Goodness by Meijer Oat-Based Plain Yogurt Alternative 24 Oz due to an undeclared - almonds.  The recall was initiated after discovering that tubs labeled as Oat-Based, actually contain Almond-Based product, which is not listed on the product label.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/meijer-announces-allergy-alert-undeclared-almonds-true-goodness-oat-based-plain-yogurt-alternative
Meijer Announces Allergy Alert on Undeclared Almonds in True Goodness Oat-Based Plain Yogurt Alternative
Summary
Company Announcement Date:  December 16, 2022
FDA Publish Date:  December 22, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Tree Nuts
Company Name:  Meijer
Brand Name:  True Goodness
Product Description:  Plain Yogurt Alternative

CA Company Recalls Meatless Breakfast Sandwiches and Burritos for Undeclared Milk

Alpha Foods, Glendale, California (December 21, 2022) - Out of an abundance of caution, Miso Brothers, Inc. dba Alpha Foods, is voluntarily recalling its Meatless Breakfast Sandwiches and Burritos due to traces of undeclared milk.  This recall was initiated after it was discovered, that the products containing traces of undeclared milk (Casein - a milk protein) were distributed in retail stores and delivered directly to consumers who purchased our products online. Subsequent investigation indicates that the contamination is likely to have occurred during the production of our products.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/alpha-foods-issues-product-recall-due-undeclared-milk-meatless-burritos-breakfast-sandwiches
Alpha Foods Issues a Product Recall Due to Undeclared Milk in Meatless Burritos & Breakfast Sandwiches
Summary
Company Announcement Date:  December 21, 2022
FDA Publish Date:  December 21, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Milk
Company Name:  The Miso Brothers Inc
Brand Name:  Alpha
Product Description:  Frozen Burritos

Imported Baklava Recalled Due to Lack of Allergen Labeling

Falcon Import and Export LLC, of Ashburn, Virginia, is recalling Alsultan Sweets branded Baklava because it may contain undeclared milk and wheat, and Alsultan Sweets branded Betefour because it may contain undeclared cashews, pistachios, and almonds.   The recall was initiated after it was discovered that products containing the allergens were distributed in packaging that did not reveal the presence of the allergens. Distribution of the products has been suspended until the labeling is corrected.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/falcon-import-and-export-llc-issues-allergy-alert-undeclared-milk-wheat-mixed-alsultan-branded
Falcon Import and Export, LLC Issues Allergy Alert on Undeclared Milk & Wheat in Mixed Alsultan Branded Baklava, and Undeclared Cashews, Pistachios, & Almonds in Alsultan Branded Betefour
Summary
Company Announcement Date:  December 20, 2022
FDA Publish Date:  December 20, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Milk and Tree Nuts
Company Name:  Falcon Import and Export LLC
Brand Name:  Alsultan
Product Description:  Baklava and Betefour

Food Code 2022 Updated from 2017 Version - A Review of Pertinent Changes

FDA released the newest version of the Food Code 2022 - https://www.fda.gov/media/164194/download

"The U. S. Food and Drug Administration (FDA) publishes the Food Code, a model that assists food control jurisdictions at all levels of government by providing them with a scientifically sound technical and legal basis for regulating the retail and food service segment of the industry (restaurants and grocery stores and institutions such as nursing homes). Local, state, tribal, and federal regulators use the FDA Food Code as a model to develop or update their own food safety rules and to be consistent with national food regulatory policy."

According to the FDA announcement, the biggest changes in this latest update include:

• Adding sesame as a major food allergen to reflect that the Food Allergy Safety, Treatment, Education, and Research Act of 2021 established sesame as the 9th major food allergen;
• Informing consumers, in writing, of major food allergens as ingredients in unpackaged food;
• Adding labeling of major food allergens in bulk food that is available for consumer self-dispensing;
• Creating new requirements for the allowance of pet dogs in outdoor dining spaces; and
• Revising the definition of intact meat, including enhancements to clarify time/temperature cooking requirements

A summary of all the changes can be found here - 

https://www.fda.gov/food/fda-food-code/summary-changes-2022-fda-food-code

Here is a closer look at some of these changes as well as a few others that stand out.  (One item to note is #8 - the lowering of temperature of the water at the handwashing sink to 85F from 100F.  Note: this is not handwashing temperature, but the requirement that the handwashing sink must be capable of delivering running water that is at least 85F)

1. Sesame was added to the list of allergens requiring proper labeling.  Employees must be trained in allergen awareness, and part of this awareness is knowing the signs and symptoms of an allergen reaction, as well as the major allergens are in the food.

2. Definitions were modified for 'intact meat' and 'mechanically tenderized meat'.

“Intact Meat” means a cut of whole muscle(s) MEAT that has not undergone COMMINUTION, MECHANICAL TENDERIZATION, vacuum tumbling with solutions, reconstruction, cubing or pounding.

"Mechanically Tenderized" means manipulating meat by piercing with a set of needles, pins, blades or any mechanical device, which breaks up muscle fiber and tough connective tissue, to increase tenderness. This includes INJECTION, scoring, and processes which may be referred to as “blade tenderizing,” “jaccarding,” “pinning,” or “needling”

This revises the definition of the term “Mechanically Tenderized” to be consistent with the USDA FSIS description of “mechanically tenderized” in the 2015 final rule titled Descriptive Designation of Needle- or Blade-Tenderized (Mechanically Tenderized) Beef Product (80 FR 28153). The rule established labeling requirements for raw or partially cooked mechanically tenderized beef products and clarified that products injected with a marinade or solution are considered mechanically tenderized.

3. Amended §1-201.10 (B) to revise the definition of the term “Ready-to-Eat Food” to indicate what Ready-to-eat Food does not include.  [This was to make it clear that just because it is manufactured by a food company, it does not make it ready-to-eat....see #6 below]

"Ready-to-eat food" does not include:
(a) Commercially pACKAGED FOOD that bears a manufacturer’s cooking instructions; and
(b) FOOD for which the manufacturer has provided information that it has not been processed to control pathogens

4.  Added additional duties to Person in charge, specifically those to ensure temperature control during thawing.  (2-103.11)

• Amended to add new paragraph (J) to address additional duty requirement for the Person in Charge to ensure food employees are properly maintaining the temperatures of time/temperature control for safety foods during thawing and redesignated paragraphs (J) – (P) as new paragraphs (K) –(Q).

(J) FOOD EMPLOYEES are properly maintaining the temperature of TIME/TEMPERATURE CONTROL FOR SAFETY FOODS during thawing through daily oversight of the FOOD EMPLOYEE’S routine monitoring of FOOD temperatures; P

5.  Added a section on food donations...basically the Food Code applies when donating food.

• Added new Subpart 3-204 on food donation under Part 3-2 Sources, Specifications, and Original Containers and Record
• Added a new § 3-204.10 titled Food Donation, to indicate when food may be offered for donation.

3-204.10 Food Donation.

FOOD stored, prepared, PACKAGED, displayed, and labeled in accordance to LAW and this Code may be offered for donation

6.  Addressing manufacturing cooking instruction (3-401.15).  Basically if a food has to be cooked per manufacturing instructions, it cannot be considered RTE.  The biggest issue may be associated with frozen vegetables that have cooking instructions that may be served. raw.

• Amended to add a new § 3-401.15 addressing manufactured food cooking instructions.

3-401.15 Manufacturer Cooking Instructions.

(A) Commercially PACKAGED FOOD that bears a manufacturer’s cooking instructions shall be cooked according to those instructions before use in READY-TO-EAT FOODS or offered in unPACKAGED form for human consumption, unless the manufacturer’s instructions specify that the FOOD may be consumed without cooking. P

(B) FOOD for which the manufacturer has provided information that it has not been processed to control pathogens, when used in READY-TO-EAT FOODS or offered for human consumption, shall be cooked according to a time and temperature appropriate for the FOOD.

7.  Amended allergen labeling for bulk foods

• Amended sub¶ 3-602.11(C)(2) to add a cross reference to sub¶ 3-602.11(B)(5) to address major food allergen labeling in bulk food available for consumer self dispensing.

(C) Bulk FOOD that is available for CONSUMER self-dispensing shall be prominently labeled with the following information in plain view of the CONSUMER:

(1) The manufacturer's or processor's label that was provided with the FOOD; or

(2) A card, sign, or other method of notification that includes the information specified under Subparagraphs (B)(1), (2), (5) and (6) of this section.

(D) Bulk, unPACKAGED FOODS such as bakery products and unPACKAGED FOODS

that are portioned to CONSUMER specification need not be labeled if:

(1) A health, nutrient content, or other claim is not made;

(2) There are no state or local LAWS requiring labeling; and

(3) The FOOD is manufactured or prepared on the PREMISES of the FOOD ESTABLISHMENT or at another FOOD ESTABLISHMENT or a FOOD PROCESSING PLANT that is owned by the same PERSON and is regulated by the FOOD regulatory agency that has jurisdiction.

8.  Lowered the water temperature requirements for hand sinks from 100F to 85F.  (5-202.12) 

• Amend ¶ 5-202.12(A) to revise the hot water temperature at the hand sink from at least 38°C (100°F) to at least 29.4°C (85°F).

5-202.12 Handwashing Sink, Installation.

(A) A HANDWASHING SINK shall be equipped to provide water at a temperature of at least 29.4oC (85oF) through a mixing valve or combination faucet. Pf

9.  Dogs MAY be allowed to be in outdoor dining areas - 6-501.115  [No mention of cats]

• Amended § 6-501.115 Prohibiting Animals to add a new exception paragraph (D) to allow for pet dogs in outdoor dining areas, where approved.

(D) If approved by the regulatory authority, food establishments may allow pet dogs in outdoor dining areas

Europe - Challenges with Increasing Level of Mycotoxins in Wheat

An article from University of Bath (UK) discusses the rise in fungal toxins in wheat and other cereal grains in Europe, specifically those toxins associated with Fusarium Head Blight.

Their findings - "Fusarium mycotoxins were discovered in every European country. Half of the wheat intended for human food in Europe contains the Fusarium mycotoxin “DON” (commonly referred to as vomitoxin) while in the UK, 70% of wheat is contaminated. Governments set legal limits on DON contamination levels in wheat that is to be consumed by humans. These regulations provide effective protection, with 95% of wheat destined for the table meeting the safety limits for DON concentration. However, the finding that mycotoxins are ubiquitous is concerning, as the effect of constant, low-level exposure to mycotoxins in our diet over the course of a lifetime is not known."

Penn State Extension has a piece on Fusarium Head Blight - Fusarium Head Blight (psu.edu)

So what may have led to this this increase?  Speaking with our European expert on grain Mold, Dr. Voloshchuk, she said two factors that need investigation are  weather conditions associated with global climate change and along with that, the push to decrease the use of fungicides.

Harmful fungal toxins in wheat: a growing threat across Europe (bath.ac.uk)
Harmful fungal toxins in wheat: a growing threat across Europe
Harmful fungal toxins are on the rise in Europe’s wheat and affect almost half of crops, according to a new study led by the University of Bath.

FDA Food Fraud - Economically-Motivated Adulteration - Honey

FDA recently issued a report on sampling and testing of imported honey for economically motivated adulteration.

• More than 70% of honey consumed in the US is imported.
• Adulteration is the addition of undeclared cheaper sweeteners to honey, such as syrups derived from cane, corn, rice or sugar beets
• Of the 144 import samples collected and tested, the FDA found 14 (10%) to be violative. The remainder were in compliance.
• Of the 144 import samples, 75 were collected from bulk shipments and 69 were collected from retail shipments.
• Violative samples are subject to compliance actions, such as recalls and import refusal, consistent with the FDA’s mission to ensure that food is safe, wholesome, and properly labeled. When appropriate, the agency may consider pursuing criminal investigations. 
• When other sweeteners are added to honey, the Federal Food, Drug & Cosmetic (FD&C) Act requires that the resulting product be labeled as a “blend,” and not as “honey,” and have an ingredient statement.

https://www.fda.gov/food/economically-motivated-adulteration-food-fraud/fy2122-sample-collection-and-analysis-imported-honey-economically-motivated-adulteration
FY21/22 Sample Collection and Analysis of Imported Honey for Economically Motivated Adulteration

Case Studies - Allergen Root Cause Analyses

An article in Food Safety Magazine, titled Anatomy of Food Allergen Recalls,  sheds light on the root cause of six different allergen-related recalls.  Key points from that article:

Egg residue in pasta product - Line spillover form one product to another

• "The pasta in this product was obtained from a pasta supplier. The manufacturer of the implicated product decided to conduct an inspection of the pasta supplier's facility. In the course of that inspection, a location was discovered where a line transporting egg noodles crossed over a line transporting this company's non-egg product. The inspector was able to discern that egg noodles would periodically drop from the noodle line into the non-egg pasta. Subsequently, a tote of the finished non-egg pasta ingredient was found to contain several egg noodles on visual inspection. Since these noodles were discrete particulates, they were not likely present in every container of the manufacturer's retorted product. Thus, the presence of egg evaded detection when only a few containers were selected for egg analysis."
• "The line crossover was identified as the root cause, and a shield was placed over the non-egg line to prevent egg noodles from dropping into the non-egg pasta."

Peanut in Chocolate Ice Cream - Rework Issue

• "A review of rework records at the manufacturing facility clearly and astonishingly showed that peanut butter swirl ice cream had been incorporated into the chocolate ice cream. The use of rework as an ingredient explains why consistent and moderately high levels of peanut residues were detected in the chocolate ice cream. Further investigation revealed that a key employee had interpreted the like-into-like as permitting the use of any flavor in rework that would not affect the color or flavor of the chocolate ice cream."
• "The use of peanut-containing rework was identified as the root cause of this recall. Corrective actions included more specific and detailed employee training on preventive allergen controls and implementation of a new rework policy (exact-into-exact), where rework was only allowed to be incorporated into the same SKU of product from which it had been generated."

Peanut in Spice Mix - Poor Supplier

• "Due to the very high levels of peanut found in the cumin, the manufacturer suspected intentional adulteration; however, such allegations are difficult to prove. Other spice mix companies that were customers of the same Turkish supplier were also found to have received and distributed seasoning mixes and ground cumin with high levels of undeclared peanut. Initially, no consumer complaints were received, but several complaints ultimately were linked to products associated with the implicated cumin. Hundreds of product recalls ensued."
• "The root cause was the presence of undeclared peanut in cumin obtained from a specific supplier. The corrective action was the cessation of the import of ground cumin from the particular Turkish supplier. Some affected companies began to source ground cumin from U.S. suppliers that imported whole cumin seeds and ground the spice in U.S. facilities."

Cumin with peanut - Farming practices

• "The cumin-growing region of India is also home to peanut farms. An observation was made by inspectors in India that many of these farmers were reusing burlap bags that may have been previously used for peanuts or peanut meal. Peanuts in India are sometimes processed into peanut oil, leaving behind peanut meal that farmers might transport in burlap bags to feed cows; those same bags might be later used to carry cumin."
• "This root cause was never fully documented, but several spice manufacturers began supplying the farmers with new burlap bags. This practice coincided with fewer cumin or cumin-containing spice mixes testing positive for peanut residues."

Undeclared Almond in Paprika - Testing failure

• "In the EU, retail paprika samples were recalled for the presence of undeclared almond. The source of the ground paprika was a Middle Eastern supplier. This supplier had no almonds in its facility, although the supplier indicated that it used shared equipment to grind both paprika and mahaleb, a popular Middle Eastern spice made from the pits of a variety of mahaleb cherries."
• "Subsequent analysis revealed that mahaleb residues would test positive in the almond ELISA methods, and mass spectrometric analysis revealed that the residues in the ground paprika had come from cherry pits and not almonds. Canada rescinded its recalls for undeclared almond in paprika. Allergen ELISA methods are typically quite specific; however, in the case of botanical cousins such as almond and mahaleb cherries, cross-reactivity is possible."
• "The root cause of these recalls was a faulty analytical method. The corrective action involved the use of a more specific analytical method to distinguish between almonds and cherry pits. Due to the close relationship between almonds and mahaleb cherries, the proteins from these two foods are likely to be highly homologous, suggesting that ingestion of mahaleb might cause reactions in almond-allergic individuals."

Cereal with undeclared milk - Overspray transfers allergens

• "A breakfast cereal manufacturer used shared processing and packaging equipment for the processing of one cereal product with milk and another with no milk-derived ingredients."
• "The manufacturer realized that droplets from the wet washing procedure were transferring onto the roll stock plastic packaging used as the inner liner for the boxes of cereal. Corrective actions involved moving the packaging equipment further away and shrouding it during allergen cleaning."

Animal Feed Recall - Alfalfa Blocks Recalled, Linked to Death of 45 Horses Due to Botulism Poisoning

Manzanola Feeds is voluntarily recalling certain lots of Top of the Rockies Alfalfa Cubes because it has the potential to be contaminated with Clostridium botulinum.  The recalled Top of the Rockies Alfalfa Cubes are approximately 1 inch cubes, packaged in a 50 pound bag,  There have been 45 horse deaths associated with this issue, to date.

According to the FDA Advisory - "Some of the alfalfa cubes have been reported to contain what appears to be fur and animal tissues, indicating that material from an animal or animals may have been incorporated into the cubes during alfalfa harvesting. Some people have reported a foul odor in some of the bags. Clostridium botulinum, the bacterium that causes botulism, is commonly present in decaying animal carcasses. Testing of the alfalfa cubes and other feed and tissue samples is in progress."


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/manzanola-feeds-recalling-certain-lots-top-rockies-alfalfa-cubes-due-possible-clostridium-botulinum
Manzanola Feeds is Recalling Certain Lots of Top of the Rockies Alfalfa Cubes due to Possible Clostridium botulinum Health Risk
Summary
Company Announcement Date:  December 16, 2022
FDA Publish Date:  December 16, 2022
Product Type:  Animal & Veterinary  Livestock Feed
Reason for Announcement:  Potential to be contaminated with Clostridium botulinum
Company Name:  Manzanola Feeds
Brand Name:  Top of the Rockies
Product Description:  Alfalfa Cubes