FDA Warning Letter - Bakery Supply Company with No FSVP in Place for Their Imported Food Items

FDA issued a Warning Letter to a bakery supply company for not having a Foreign Supplier Verification Program (FSVP) for items that they are importing and then selling.  These items include multi-color sprinkles, Strawberry filling, and Bavarian cream.

Companies who import products must have assurances that food made overseas meets US standards.  For those who are importing and reselling that food in the US, whether that food will be sold without further processing (sold as-is) or sold to a company who will use it as an ingredient in food they process (such as in the case here), that importer must have a FSVP in place for all items / each supplier in place.

It is important for companies who are using imported ingredients purchased from a US broker / importer, that they know that importer / broker does indeed comply with the FSVP rule.

It's also good to know if the items you use are imported.  One could guess that few question whether their multi-colored sprinkles are imported.  And it's not like someone is sourcing imported sprinkles like choosing imported fine wines...ah yes, I use only the Châteauneuf-du-Pape sprinkles please.  Or that the sprinkles can only be sourced from some exotic location...there is no Juan Valdez trekking up into the Andes to pick them from the scarce Jimmy trees.  So where do your sprinkles come from?

Is it a big deal?  From risk perspective, as an RTE item, we would want to have knowledge that the items must meet US standards for safety, including measures that prevent cross-contamination.  The FVSP Rule requires importers to evaluate the hazards of the items and ensure necessary controls are in place.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/el-molino-bakery-supplies-inc-593693-12162019
FDA WARNING LETTER 

El Molino Bakery Supplies Inc
MARCS-CMS 593693 — December 16, 2019

FDA Updates the 2017 Food Code with 2019 Supplement

Every two years, FDA updates the food code either by issuing a new code or by providing a supplement.  On this update, it provides a supplement.  Below are the items FDA viewed as important changes.  We provided a quick assessment and the rule change for ease of seeing these changes.

Item - Allow food establishments in limited circumstances, such as in a restricted office building or break room, that pose minimal risk of causing, or contributing to foodborne illness to operate without a person in charge, as approved by the regulatory authority.

Quick summary/impact - No overall impact except in breakroom applications where food is offered but there is no attendant.  Food offered is viewed as minimal risk.
Section Addition - 2-101.11Assignment.

(C)This section does not apply to certain types of FOOD ESTABLISHMENTS deemed by the REGULATORY AUTHORITY to pose minimal risk of causing, or contributing to, foodborne illness based on the nature of the operation and extent of the FOOD preparation.Pf

Application from Annex -  The concept of an unmanned food establishment that is typically located in an office building or restricted break area is a recent innovation. While a wide variety of food items may be provided, these operations are intended to offer packaged TCS and non-TCS food products that are displayed via refrigeration units, food racks, baskets and/or countertop display units. There are a number of state and local agencies that mandate the permit holder be the person in charge or designate a person in charge present at the food establishment during all hours of operation.

Item - “time without temperature control” is used as the public health control for ready-to-eat produce and hermetically sealed food upon cutting, chopping or opening of the hermetically sealed container. This exception allows these foods to begin at 70°F or less and remain at 70°F for a maximum of 4 hours.

Quick Summary/Impact - Once one cuts produce or opens a commercially sealed can, the food becomes a TCS food, and this section provides notice that foods can only be left out at room temperature (no temperature control) for a maximum of 4 hours

Section Addition- 3-501.19 Time as a Public Health Control

(B) If time without temperature control is used as the public health control up to a maximum of 4 hours:
(1) Except as specified in (B)(2), the FOOD shall have an initial temperature of 5ºC (41ºF) or less when removed from cold holding temperature control, or 57°C (135°F) or greater when removed from hot holding temperature control; P
(2) The FOOD may have an initial temperature of 21°C (70°F) or less if;
(a)It is a READY-TO-EAT fruit or vegetable that upon cutting isrendered a TIME/TEMPERATURE CONTROL FOR SAFETY FOOD as defined in ¶1-201.10(B), or
(b)It is a READY-TO-EAT hermetically sealed FOOD that uponopening is rendered a TIME/TEMPERATURE CONTROL FOR SAFETY FOOD a defined in ¶1-201.10(B),
(c)The FOOD temperature does not exceed 21°C (70°F)within a maximum time period of 4 hours from the time it was rendered a TIME/TEMPERATURE CONTROL FOR SAFETY FOOD; and
(d)The FOOD is marked or otherwise identified to indicate the time that is 4 hours past the point in time when the FOOD is rendered a TIME/TEMPERATURE CONTROL FOR SAFETY FOOD as specified in sub¶¶’s (B)(2)(a) and (b) of this section.
((3)The FOOD shall be marked or otherwise identified to indicate the time that is 4 hours past the point in time when the FOOD is removed from temperature control; Pf
(4)The FOOD shall be cooked and served, served at any temperature if READY-TO-EAT, or discarded, within 4 hours from the point in time when the FOOD is removed from temperature control; P and
(5)The FOOD in unmarked containers or PACKAGES, or marked to exceed a 4-hour limit shall be discarded. P

Application from Annex - At the 2018 meeting of the CFP it was recommended that Section 3-501.19 be amended to allow raw agricultural commodities (RACs) that are cut on-site (such as tomatoes, melons, or leafy greens) or shelf-stable hermetically sealed containers (such as canned tuna) opened on-site have an initial temperature of 21°C (70°F) or less when time without temperature control is used as a public health control for a maximum of 4 hours. Peer-reviewed scientific literature and the above-mentioned pathogen modeling has shown Salmonella spp. and L. monocytogenes will not exceed a 1-log increase in growth when started and maintained at 21°C (70°F) or less for up to 4 hours.

Item - Remove the allowance for use of chemically treated towelettes for hand washing because the means to wash hands in limited situations is readily available and hand washing has been determined to be effective.

Quick Summary / Impact - The use of chemically treated towelettes was allowed for handwashing stations.  This was dropped, so no longer can be used to fulfill handwashing stations.

Deleted Section - 5-204.11

(C) If APPROVED, when FOOD exposure is limited and HANDWASHING SINKS are not conveniently available, such as in some mobile or TEMPORARY FOOD ESTABLISHMENTS or at some VENDING MACHINE LOCATIONS, EMPLOYEES may use chemically treated towelettes for handwashing.

Item -  Expand and clarify the type of information that should be included when a Hazard Analysis and Critical Control Point Plan is required by a regulatory authority.

Quick Summary/Impact - Adds information on what needs to be required in a HACCP plan.  If one goes through HACCP training, they would know they need to have this.

• General information on the establishment including name, address, and contact information;
• The types of foods covered
• flow diagram or chart for each specific FOOD or category type that identifies each step in the process; those steps that are designated CRITICAL CONTROL POINTS; Pf
• The ingredients, recipes or formulations, materials and equipment used in the preparation of each specific FOOD or category type and methods and procedural control measures that address the FOOD safety concerns involved; Pf
• A CRITICAL CONTROL POINTS summary for each specific FOOD or category type that clearly identifies:
• (1) Each CRITICAL CONTROL POINT, Pf
• (2) The significant HAZARDS for each CRITICAL CONTROL POINT, Pf
• (3) The CRITICAL LIMITS for each CRITICAL CONTROL POINT, Pf
• (4) The monitoring procedure for each CCP including method and frequency as well as designated person
• (5) Correction Action
• (6) Verification
• (7) Record keeping

Item - Added guidance documents for chicken livers and for mail order foods.

Quick Summary / Impact - documents for reference on chicken livers and mail order food.

The mail order document provides good information on those mailing food and is worth reviewing.

Section- Amend 3. Supporting Documents to add the following new sections W and X to read as follows:

W.Minimizing the Risk of Campylobactor and Salmonella Illnesses Associated with Chicken Liver

USDA-FSIS has found that from 2000 to 2015, chicken livers were associated with 22 outbreaks most commonly due to undercooking. USDA-FSIS’ Compliance Guideline, Minimizing the Risk of Campylobacter and Salmonella Illnesses Associated with Chicken Liver provides additional guidance that retailers and others can use to reduce or eliminate pathogens, thereby decreasing the likelihood of foodborne illness outbreaks from this product. The guidance document explains why searing the outside of the liver is not adequate for pathogen elimination in chicken livers and emphasizes appropriate cooking to an internal temperature of 165F to avoid illnesses. Thorough cooking is the only method to eliminate pathogens. This guidance also provides other recommendations to minimize (but not eliminate) pathogen contamination associated with undercooked chicken liver dishes.

This document is available for download at:

https://www.fsis.usda.gov/wps/wcm/connect/b3f4efe7-27d4-4c39-bce7-011b7bbd1e7d/Chicken-Liver-Guidance-July-2018.pdf?MOD=AJPERES

X.Guidance Document for Mail Order Food Companies

This guidance document is intended for retail food establishments delivering perishable foods to the consumer by mail order. The intent of the guide is primarily to provide best practices for preventing biological, physical and chemical contamination, as well as the growth of harmful bacteria and/or the formation of toxins within the food being shipped. Foodborne illness may occur if products are not prepared, packed and shipped using sanitary conditions and proper temperature controls. It is the result of a joint effort by the FDA and the Conference for Food Protection.

This document is available for download at:

http://www.foodprotect.org/media/site/cfp-mail-order-committee-draft-document-per-2018-iii-004.pdf

Retail Food Protection
https://www.fda.gov/retailfoodprotection
FDA Releases Supplement to the 2017 Food Code
December 23, 2019

Michigan Company Recalls Tahini After State Tests Indicate Salmonella

Emesa Foods, Taylor, MI is voluntarily recalling 23 cases and each case 6 containers of 800 gram of “Premium Sesame Tahini” because it has the potential to be contaminated with Salmonella.  This potential problem was revealed as a result of a random sampling by the Michigan Department of Agriculture and Rural Development. Although we have not received the final laboratory reports, Emesa Foods is taking the precaution of recalling product with the product code listed above.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/emesa-foods-recalls-premium-sesame-tahini-because-possible-health-risk
Emesa Foods Recalls Premium Sesame Tahini Because of Possible Health Risk
Summary
Company Announcement Date:  December 20, 2019
FDA Publish Date: December 20, 2019
Product Type: Food & Beverages
Reason for Announcement: Product has the potential to be contaminated with Salmonella
Company Name: Esmea Foods
Brand Name: Esmea
Product Description: Sesame tahini

Food Companies Issue Recalls After Using Eggs Recalled for Listeria

A number of food companies have issued recalls after using eggs recalled as part of the Almark egg recall due to Listeria.

• Meijer Recalls Diced Hard Boiled Eggs Due to Potential Health Risks Product Bought at Two Stores in Grand Rapids Affected
• Veggie Noodle Co., LLC is voluntarily recalling its Cece’s® Veggie Co. brand Fresh Veggie Ramen with Chicken Broth (11.5 oz, UPC 5228700653), all expiration dates, sold at retail stores nationally, 
• Reichel Foods Inc. is voluntarily recalling Pro2Snax to the Max Sliced Apples, Hard Boiled Egg, Mild Cheddar Cheese, Cashews & Dried Cranberries and Pro2Snax to the Max Sweet Gala Apples, Hard Boiled Egg, White Cheddar Cheese, Almonds & Dried Cranberries.
• Great American Deli of Ooltewah, Tennessee is recalling GAD #114 Egg Salad Sandwich 4.8 oz. 
• Bakkavor Foods USA, Inc. is voluntarily recalling Trader Joe’s Egg Salad, 6 oz and Trader Joe’s Old Fashioned Potato Salad, 20 oz with “USE BY” date codes up through and including 12/27/19 

As part of the hazard analysis for receiving eggs, Listeria would be a hazard of concern and would be handled by Supplier Preventive Control.  After this recall, a more substantive system will be need for RTE peeled eggs.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/meijer-recalls-diced-hard-boiled-eggs-due-potential-health-risks-product-bought-two-stores-grand
Meijer Recalls Diced Hard Boiled Eggs Due to Potential Health Risks Product Bought at Two Stores in Grand Rapids Affected
Summary
Company Announcement Date: December 31, 2019
FDA Publish Date: December 31, 2019
Product Type:  Food & Beverages Egg/Egg Product Foodborne Illness
Reason for Announcement: Product has the potential to be contaminated with Listeria monocytogenes
Company Name:Meijer
Brand Name: None
Product Description:  Hard-boiled eggs

Georgia Egg Processing Facility Expands Egg Recall Due to Listeria

Almark Foods, a GA egg processing facility expanded a recall after product was linked to a Listeria outbreak.  The recall issued on Dec 20, was expanded on Dec 23rd.  In an update provided by CDC and FDA, the suspect strain was found in the processing facility.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/almark-foods-expanded-recall-all-products-its-georgia-facility-due-possible-listeria-monocytogenes
Almark Foods Expanded Recall to all Products from its Georgia Facility Due to Possible Listeria monocytogenes Contamination
Summary
Company Announcement Date: December 23, 2019
FDA Publish Date: December 23, 2019
Product Type: Food & Beverages Egg/Egg Product Foodborne Illness
Reason for Announcement: Potential to be contaminated with Listeria monocytogenes
Company Name: Almark Foods\
Brand Name: Almark, 7 Select, Best Choice, more\
Product Description: All hard-boiled eggs manufactured at the firm’s Gainesville, Georgia facility, including all retail, pillow pack, pouch pack, frozen diced, and protein kit products
Company Announcement

Developing a Food Fraud Prevention System

Over the past several years, we have had more questions on food fraud and developing a program to prevent the potential for food fraud.  An article in Food Safety News this past month, discusses a Food Fraud Management System.   Like a HACCP or even more so, a Food Defense system, it entails conducting a vulnerability assessment and identifying mitigating actions.  One of the key takeaways from the article, and it certainly makes sense, this system must constantly evolve.  It is not a system that can be developed and then be shelved for a year.  It requires continuous surveillance and probing by employees throughout the organization.

Food fraud is not a known risk, it is a risk that can emerge out of nowhere as a perpetrator finds a new way to take advantage of a vast food supply chain.  Catching this may not be an easy task, especially for one person assigned to the task.

Food Safety Magazine
https://www.foodsafetymagazine.com/magazine-archive1/december-2019january-2020/reducing-the-risk-of-fraud-in-the-spice-industry/
Reducing the Risk of Fraud in the Spice Industry
By Jill Hoffman

FDA Update on E. coli Outbreak Associated with Romaine from Salinas CA - Dec 19

FDA provided an update on the E. coli Outbreak associated with Romain from Salinas CA.  There are not 138 cases with 72 hospitalizations.  The last case reported is now Dec 1, 2019.

Wisc Dept of Health found the outbreak strain of E. coli in a bag of Fresh Express brand Leafy Green Romaine collected from an ill person’s home.  This allowed them to identify one of the growers who also provided Romaine to others linked to this outbreak.

https://www.fda.gov/food/outbreaks-foodborne-illness/investigation-e-coli-o157h7-outbreak-linked-romaine-salinas-california-november-2019
Investigation of E. coli O157:H7 Outbreak Linked to Romaine from Salinas, California, November 2019
FDA continues to warn against eating romaine from Salinas; farm investigations continue

December 19, 2019

Case Counts

• Total Illnesses: 138
• Hospitalizations: 72
• Deaths: 0
• Last illness onset: December 1, 2019
• States with Cases: AZ (3), CA (4), CO (6), FL (2), IA (1), ID (3), IL (10), MD (5), MI (1), MN (5), MT (1), NE (2), NJ (9), NC (2), NM (2), OH (12), OR (1), PA (17), SC (1), SD (1), TN (1), TX (6), VA (6), WA (4), WI (33)

CDC Alert on Listeria Outbreak Associated with Hard-boiled Peeled Eggs from GA Processor

CDC issued a food safety alert regarding hard boiled eggs from Alamark Foods as a potential source of Listeria.   "As of December 17, 2019, a total of seven people infected with the outbreak strain of Listeria monocytogenes have been reported from five states...... Epidemiologic and laboratory evidence indicates that bulk hard-boiled eggs produced by Almark Foods of Gainesville, Georgia, are a likely source of this outbreak." 

These eggs are hard-boiled, peeled, and packaged in plastic pails of various sizes.  It is during the peeling and packaging process where the eggs can become contaminated with Listeria.  Being a RTE product, the eggs will generally be eaten without further preparation, or certainly without preparation that would provide bacterial reduction (deviled eggs for example).  With a 49 day shelf-life at refrigeration temperatures, that is plenty of time to allow for the growth of this psychrotropic pathogen (capable of growth at refrigeration temperatures).


CDC Food Safety Alert
https://www.cdc.gov/listeria/outbreaks/eggs-12-19/index.html
Outbreak of Listeria Infections Linked to Hard-boiled Eggs
Posted December 18, 2019 at 6:30 PM ET

FDA Warning Letter to RTE Cheese Processor

FDA issued a Warning Letter to a cheese facility in Miami.  Issues include no Preventive Control Plan and really poor GMPs (dripping condensate, leaking pipes, and inadequate sanitation).  And they are producing RTE cheese product of some sort.

The thing that gets you is the company name....US Dairy Unlimited.   You are thinking with a name like that, that is a serious operation.  Could have called it Ury's Cheese, but who would buy that.  But US Dairy Unlimited....there are no limits to what they can do, or so one would think.

But looking at the facility (based on address from notice on Google Map Street view), it looks like nothing like Dairy Unlimited.  Not to say they can't make good products, but if this is your supplier, you may want to investigate a little closer.  For example, your purchasing person informs you that they have contracted a new co-packer....US Dairy Unlimited.  What supplier approval process granted this?

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/us-dairy-unlimited-llc-590413-11192019
WARNING LETTER
U.S. Dairy Unlimited, LLC
MARCS-CMS 590413 — November 19, 2019