FDA Issue Report on Salmonella Outbreak Linked to Leafy Greens from Indoor Growing Facility

FDA released their report on a 2021 Salmonella outbreak that was linked to packaged leafy greens produced at a Controlled Environmental Agriculture (CEA) indoor hydroponic operation [a fancy indoor greenhouse].  The outbreak occurred in July and August of 2021 and was caused by Salmonella Typhimurium which infected 31 people and resulted in 4 hospitalizations.

One would think that product produced in a controlled setting would be free from pathogens.  However, there were many opportunities for contamination and a lack of control.  And an indoor greenhouse is not much different than a processing facility where controls are needed.  While a definitive source was not found, here is a brief summary of some of the issues"

• The operation stored its nutrient-rich growth media used in an outdoor location that was not adequately protected from potential sources of contamination such as animal intrusion, bird droppings, or water runoff.
• The use of production pond water, while not intended to be an issue with leafy greens final product, but control of the water was questioned and there were inadequate controls for the water itself, with FDA isolating a different strain of Salmonella (not the one involved in the outbreak.
• Harvesting equipment lacked adequate control, and condensate with the facility.
• Inadequate validation support for cooling greens after packaging.
• Issues with storm water retention pond in close proximity to the facility (25ft).  This pond did test positive for the outbreak strain.
• The firm did not adequately document that cleaning and sanitizing of equipment, tools, and buildings used in growing operations is routinely conducted in accordance with the firm’s procedures

FDA highlighted the recommendations that focused on the need to better understand the microbial risks and put in place better controls.
The full report can be found here - https://www.fda.gov/media/155402/download

Investigation Report: Factors Potentially Contributing to the  Contamination of Packaged Leafy

Greens Implicated in the Outbreak of Salmonella Typhimurium During the Summer of 2021

https://www.fda.gov/media/155402/download

Peppermint Baking Chips Recalled for Allergens After Packing Error by Co-Packer

Lily’s Sweets, is voluntarily recalling 18,855 cases of 7-ounce Peppermint Flavor Baking Chips due to the presence of soy lecithin.  "The error was discovered after consumers contacted the company and reported finding the white candy pieces mixed with Lily’s Peppermint Flavor Baking Chips. We have determined that the error occurred at a co-manufacturer. The white disc-shaped candy pieces contain soy lecithin, sugar, and other ingredients that are not present in Lily’s Peppermint Flavor chips." 

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lilys-sweets-voluntarily-recalls-lilys-peppermint-flavor-baking-chips-due-undeclared-presence-soy
Lily’s Sweets Voluntarily Recalls Lily’s Peppermint Flavor Baking Chips Due to Undeclared Presence of Soy Lecithin
Summary
Company Announcement Date:  January 14, 2022
FDA Publish Date:  January 14, 2022
Product Type:  Food & Beverages
Reason for Announcement:  May contain undeclared soy lecithin
Company Name:  Lily’s Sweets
Brand Name:  Lily’s
Product Description:  Peppermint Flavor Baking Chips

Review Article - Kombucha

In this months Journal of Food Science , a review of Kombucha was published titled, Kombucha: A review of substrates, regulations, composition, and biological properties (Jan 2022). The article is a good review of what we know, and what we don't know, about the increasing popular drink Kombucha.

Kombucha is a beverage traditionally obtained by the fermentation technique of tea with added sugar by a SCOBY (symbiotic culture of bacteria and yeast).

The article discusses the evolution of Kombucha to include additional substrates.  This type of research is good to have for those who push the boundaries of this fermented product.  The article also details many of the benefits, but points out "According to literature data, there are many benefits attributed to kombucha, however, it is important to emphasize that the studies are carried out predominantly in animals, or in vitro in cell cultures of animals or humans, with no evidence yet to support these benefits to human health (Kapp & Sumner,2019). Still, despite not being able to receive any official claims about its health effects, kombucha can be considered a high-value food product in a healthy diet (Jayabalan et al.,2014)."

There is still a lot of research needed to better understand the science - organisms involved in the ferementation, the benefits to human health, and potential toxic affects.

IFT Journal of Food Science
https://ift.onlinelibrary.wiley.com/doi/epdf/10.1111/1750-3841.16029
Kombucha: A review of substrates, regulations,composition, and biological propertiesJeniffer Ferreira de Miranda1Larissa Fernandes Ruiz1Cíntia Borges Silva1Thais Matsue Uekane1Kelly Alencar Silva1Alice Gonçalves Martins Gonzalez1Fabrício Freitas Fernandes2Adriene Ribeiro Lima

Abstract:

NC Company Expands Recall of Cream Puffs Due to Metal Fragments

A NC food company is expanding their late December recall  of chocolate covered cream puffs for potential metal fragments.  "Poppies International, Inc. of Battleboro, NC is expanding their voluntary recall to include the Taste of Inspirations Crème Puffs 30ct container, UPC 7 25439 99597 9, Lot # L2I5021 Best Before Date 06/08/23 that were made during December 7-10, 2021, due to the possible presence of small metal fragments. The issue was discovered during production. To date no injuries or incidents have been reported in connection with the recalled items."


FDA Recall Notice
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/poppies-international-expands-voluntary-recall-chocolate-enrobed-and-cream-puff-products-due
Poppies International Expands Voluntary Recall of Chocolate Enrobed and Cream Puff Products Due to Presence of Metal
Summary
Company Announcement Date:  January 10, 2022
FDA Publish Date:  January 11, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Possible presence of small metal fragments.
Company Name:  Poppies International, Inc.
Brand Name:  Taste of Inspirations
Product Description:  Cream Puffs

FDA Revokes Standard of Identity for French Dressing

FDA is revoking the Standard of Identity for French Dressing. The Standard, initially established in 1950 and modified over time. "The French dressing standard allowed for certain flexibility in manufacturers’ choice of oil, acidifying ingredients, and seasoning ingredients. Tomatoes or tomato-derived ingredients were among the seasoning ingredients permitted, but not required. Amendments to the standard since 1950 have permitted the use of additional ingredients, such as any safe and suitable color additives that impart the color traditionally expected (39 FR 39543 at 39554-39555"

"Most, if not all, products currently sold under the name “French dressing” contain tomatoes or tomato-derived ingredients and have a characteristic red or reddish-orange color. They also tend to have a sweet taste. Consumers appear to expect these characteristics when purchasing products represented as French dressing. Thus, it appears that, since the establishment of the standard of identity, French dressing has become a narrower category of products than prescribed by the standard. These products maintain the above characteristics without a standard of identity specifically requiring them." Plus there are variations in fat (oil).

So basically, the Standard of Identity is not needed.   "Therefore, after considering the petition and related information, through the proposed rule, we tentatively concluded that the standard of identity for French dressing no longer promotes honesty and fair dealing in the interest of consumers consistent with section 401 of the FD&C Act and proposed to revoke the standard of identity for French dressing. The preamble to the proposed rule also noted that the proposed revocation is consistent with section 6 of Executive Order 13563, “Improving Regulation and Regulatory Review” (January 18, 2011), which requires agencies to periodically conduct retrospective analyses of existing regulations to identify those “that might be outmoded, ineffective, insufficient, or excessively burdensome, and to modify, streamline, expand, or repeal them” accordingly."

FDA Warning Letter - GA Ice Cream Facility with Listeria Control Issues

FDA issued a Warning Letter to Greenwood Ice Cream, an ice cream manufacturing facility located in Chamblee, GA.

The biggest issue was inadequate control in the post-processing area where product is exposed.  As a RTE product, Listeria, as well as allergens, are a significant risk.  From the inspection notes, the company was not doing an very good job.  FDA "found that eight (8) of eighty-five (85) swabs were positive for L. monocytogenes. Of the positive findings, one (1) swab was collected from an area adjacent to food-contact surface where RTE ingredients were being prepared on the filling table. This was not the first time L. monocytogenes was found in environmental samples collected at your facility. In 2017, FDA detected L. monocytogenes in one (1) environmental swab of a floor drain, and in 2018 FDA detected L. monocytogenes in eight (8) environmental swabs, including from areas adjacent to food-contact surfaces."

On further analysis, "Whole genome sequencing (WGS) was conducted on the above referenced L. monocytogenes isolates obtained from the FDA environmental samples. Based on the results of the WGS analysis, the seventeen (17) isolates comprise three (3) different strains of L. monocytogenes. Of particular significance, fourteen (14) isolates derived from the environmental samples collected at your facility during our 2021, 2018, and 2017 inspections were genetically identical, representing a single strain of L. monocytogenes. Additionally, these fourteen (14) isolates were also genetically identical to three (3) environmental swabs collected by Georgia Department of Agriculture (GDA) during a 2016 inspection of your facility. The presence of the same strain of L. monocytogenes over multiple years is indicative of a resident pathogen or harborage site in your facility since 2016. We advised you of the importance of these WGS results via a conference call on August 3, 2021."

Along with this, there was inadequate controls for allergens, and a number of GMP issues that would have exasperated the Listeria issue.

After the Listeria outbreak associated with Blue Bell ice cream, you would think that there would be a greater level of concern for Listeria control in ice cream processing facilities. 

FDA WARNING LETTER

Greenwood Ice Cream, LLC - 616395 - 12/17/2021 | FDA
Greenwood Ice Cream, LLC
MARCS-CMS 616395 — DECEMBER 17, 2021

FDA Warning Letter - Illinois Food Repacking and Distribution Facility

FDA issued a Warning Letter to International Golden Foods, a repackaging and storage facility, located in Bensenville, IL.  The company repackages a variety of ready-to-eat (RTE) foods (e.g., tree nuts, seeds, and dried herbs and spices) and non-RTE foods (e.g., milled rice, rice flour, dried pasta, and wheat flour). The facility also stores and distributes RTE soft fresh cheeses (e.g., feta cheese and goat’s milk cheese) and pre-packaged ready-to-eat food products (e.g., tahini, grilled eggplant, pickles, dates, and figs). 

The company did not prepare, or have prepared, and did not implement a food safety plan, as required by regulation.  Preventive Controls were not in place including Allergen Preventive Controls.

From a facility and operational standpoint, there were some major issues including:

• cheeses stored at incorrect temperatures (>59F)
•  a machine used for repackaging with a cracked observation panel, a machine transfer chute made of cloth material that was not washed, and a hopper with rough seams that were discolored. 
• a live bird in your warehouse which opens directly to the repackaging room where is food is exposed. In addition, bird droppings were observed on the floor throughout the warehouse between pallets of products. 

From the company's website, we can see an importer who distributes international products.  They also repack these items to meet retail client needs.  So often we see distributors who decide to repack items without considering regulations.

FDA WARNING LETTER
International Golden Foods Inc - 619417 - 12/15/2021 | FDA
International Golden Foods Inc
MARCS-CMS 619417 — DECEMBER 15, 2021

SE PA Hepatitis Outbreak Affects 11 with One Death, Restaurant Under Investigation But Denies Involvement

The Montgomery County, PA,  Department of Health is reporting 11 cases of Hepatitis (9 confirmed) with one death.  The infections occurred in late November (it can take up to 6 weeks to see symptoms) so this makes the investigation more difficult.  

A pizzeria is being investigated as the link by the Health Department, which closed the restaurant.  The restaurant ownership denies involvement citing a clean inspection and no ill workers.

6 ABC Action News

https://6abc.com/hepatitis-a-outbreak-montgomery-county-restaurant-ginos-ristorante-west-norriton/11438258/
Montco restaurant closed amid investigation into deadly Hep A outbreak; 11 cases under investigation

Officials said 11 total cases are under investigation, with nine confirmed cases of Hepatitis A and two potential cases.

WI Establishment Recalls Snack Sticks After Packaging Label Error

Abbyland Foods, Inc., an Abbotsford, Wisc. establishment, is recalling approximately 14,976 pounds of beef sticks due to misbranding and undeclared allergens, the product contains milk, a known allergen, which is not declared on the product label.  The smoked beef sticks were produced between Nov. 15 and Nov. 17, 2021.  The problem was discovered after the firm received consumer complaints of cheese in the product and reported the event to FSIS.

So snack sticks with cheese were incorrectly labeled with the label for regular beef stick product.

https://www.fsis.usda.gov/recalls-alerts/abbyland-foods-inc.-recalls-beef-stick-product-due-misbranding-and-undeclared
Abbyland Foods, Inc. Recalls Beef Stick Product Due to Misbranding and Undeclared Allergens
FSIS Announcement

WASHINGTON, January 8, 2022 – Abbyland Foods, Inc., an Abbotsford, Wisc. establishment, is recalling approximately 14,976 pounds of beef sticks due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains milk, a known allergen, which is not declared on the product label.
The smoked beef sticks were produced between Nov. 15 and Nov. 17, 2021. The following products are subject to recall: