Friday, January 31, 2020

WHO Updated Coronavirus Information Indicates Increase in Case Numbers

WHO provided an update that indicates a 10 fold increase in the number of cases from last week.  CDC is monitoring the situation, and as of 1/31/20, there have been 6 confirmed cases in the US.

This is not really a food related issue in that it is transferred via infected people to other people, but China has put a ban on the wildlife trade  (which is not a bad thing anyway).

World Health Organization
https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200130-sitrep-10-ncov.pdf?sfvrsn=d0b2e480_2
Novel Coronavirus(2019-nCoV) Situation Report - 10
SITUATION IN NUMBERS 
Globally  7818 confirmed 
 China   7736 confirmed
              12167 suspected 
              1370 severe   
              170 deaths       
Outside of China       82 confirmed      18 countries
US 5 confirmed  (now 6)
Canada 3 confirmed
Ukraine 0 confirmed (the baushkas will have none of that going on)

FDA Issues Warning Letter to AZ Candy Company

An Arizona candy company was issued a Warning Letter by FDA.
The main issues were:
1) In the hazard analysis, they did not evaluate all of the ingredients used in the product.  The hazard analysis must evaluate every ingredient in the process.
2) There was an issue with the environmental monitoring.  I have a little issue here with the FDA's statements.  Environmental monitoring is specific for the facility.  There should not be a need for testing for Listeria in a candy facility.  Not to say environmental monitoring is not needed, however, I would like to see some additional support for the comments FDA is stating in this item.
3) The firm was buying raw nuts and roasting them, but the firm claimed that Salmonella was not a hazard because there was Supplier Control.  But clearly, the firm would have a Process Preventive Control in terms of Roasting.
4) The firm did not have a good pest control program.

From the report, Item 1.
Your hazard analysis for your RTE peppermint snow mints, chocolate pretzel clusters, and cinnamon honey peanut butter did not include an evaluation of all ingredients used to manufacture these products.
Specifically,
a. The hazard analysis for "[Chocolate] Molding," which applies to its use in peppermint snow mints, did not identify or evaluate potential hazards for the ingredient crushed peppermint/candy cane, such as recontamination with environmental pathogens and unapproved colors/additives.
b. The hazard analysis for "[Chocolate] Molding," which applies to its use in chocolate pretzel clusters, did not identify or evaluate potential hazards with the ingredient pretzels, such as recontamination with environmental pathogens.
c. The hazard analysis for (b)(4), which applies to the performance of this activity to make cinnamon honey peanut butter, did not identify or evaluate potential hazards for the ingredient ground cinnamon, such as Salmonella spp. and heavy metals, and for the ingredient honey, hazards such as drug residues and pesticides.

Chicago Establishment Recalls Ground Beef After 2 Complaints of Clear Plastic in Product

Amity Packing Company Inc., a Chicago, Ill. establishment, is recalling approximately 2,020 pounds of raw ground beef products that may be contaminated with extraneous materials, specifically clear, thin pliable plastic.  The problem was discovered after Pre Brands LLC. received two consumer complaints reporting findings of clear, thin pliable plastic in raw ground beef.

https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2020/recall-003-2020-release
Amity Packing Company Inc. Recalls Raw Ground Beef Products Due to Possible Foreign Matter Contamination 
Class II Recall
003-2020
Health Risk: Low
Jan 24, 2020

FDA Issues Warning Letter to Manufacturer of RTE Ingredient

FDA issued a Warning Letter to an Ohio firm that manufacturers RTE ingredients.  The problem was that the firm had a Listeria issue (discovered by their customer who tested the product and probably reported via the Reportable Food Registry).  Upon inspection by the FDA, the firm did not have good cleaning procedures and was not responding to Listeria positive samples.  The firm did not not implement effective corrective action procedures to include that root cause analysis, specifically - "did not perform an investigation to locate a potential source of contamination or make any changes to your sanitation practices."  The firm also had some poor practices including the use of high pressure hoses as well as improper cleaning of transfer pipes.

From the Letter

  • "Specifically, your food safety plan identified environmental pathogens as a hazard requiring preventive controls and identified sanitation controls to address the hazard, but you did not fully implement your “Sanitation Standard Operating procedure (SSOP), We also gathered documentation that one of your customers tested and found your aji amarillo paste to be positive for L. monocytogenes." 
  • "In addition, a review of records of your weekly environmental monitoring program for Listeria spp. shows that (b)(4).  (b)(4) collected by FDA during our most recent inspection were positive for L. monocytogenes. Furthermore, your finished aji amarillo paste product was found to be positive for L. monocytogenes (b)(4)."
  • "Whole genome sequencing analysis showed the L. monocytogenes isolates from the environmental swabs collected by FDA were the same strain as that in the finished product aji amarillo paste tested by your customer. Your environmental testing results and these findings demonstrate that your sanitation procedures have been inadequate to significantly minimize or prevent the hazard of L. monocytogenes in your facility"
  •  "You did not implement your written corrective action procedures to address the presence of an environmental pathogen or appropriate indicator organism detected through your environmental monitoring, as required by 21 CFR 117.150(a)(1)(ii). Specifically, in your food safety plan, you identified (b)(4). (Environmental monitoring is a verification activity for preventive controls as reflected in 21 CFR 117.165(a)(3).) Your environmental monitoring program lists the following corrective actions after a presumptive positive for Listeria spp.: (b)(4). Your weekly environmental monitoring program for Listeria spp. (b)(4). Each time, your corrective actions were limited to (b)(4). You did not perform an investigation to locate a potential source of contamination or make any changes to your sanitation practices."
  • "You did not clean and sanitize utensils and equipment in a manner that protects against allergen cross-contact and against contamination of food, food-contact surfaces, or food-packaging materials, as required by 21 CFR 117.35(a). On March 28, 2019, our investigator observed an employee using a high-pressure hose to spray the mezzanine floor with water while performing sanitation operations. Water overspray created a mist surrounding the open medium ribbon blender used to manufacture aji amarillo paste. On April 2, 2019, our investigator observed water overspray around the blue (b)(4) pallets on which employees were cleaning product transfer hoses, (b)(4) blades, a (b)(4), (b)(4) hopper, and (b)(4) fixtures used in the manufacture of the aji amarillo paste. Our investigator also observed an employee cleaning a product transfer pipe without cleaning the full interior of the pipe."


FDA Warning letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/yost-foods-inc-581473-09102019
Yost Foods, Inc 
MARCS-CMS 581473 — September 10, 2019

This Week in Mislabeled Products for Week Ending February 1, 2020

Chicken Soup Packed in Wrong Package, Allergen Missing  - Bakkavor Foods USA, Inc. is voluntarily recalling 840 units of Harris Teeter’s Fresh Food Market Mushroom Barley Soup, 16 oz with “SELL BY” date codes 03/09/20 because it may contain undeclared milk.  The recall was initiated after it was discovered that Chicken Wild Rice Soup containing Milk was distributed in Mushroom Barley Soup packaging that did not reveal the presence of Milk. The problem was discovered when a Harris Teeter employee was stocking store shelves and noticed the discrepancy.

Non-Dairy Creamers Can Contain Caseinate, a Dairy Protein And Must Be Declared as Milk - Beepa’s of Beloit, WI is recalling Goulash, because it may contain undeclared milk.  The recall was initiated after it was discovered that product containing Milk was distributed in packaging that did not reveal the presence of Milk in the sub ingredients of the non dairy creamer.

Pizza Packed in Wrong Package, Allergen Missing - Astrochef LLC., a Rockwall, Texas establishment, is recalling approximately 7,363 pounds of pepperoni stuffed pizza sandwich products because the product is mislabeled and contains undeclared soy, - the products are labeled as pepperoni stuffed pizza sandwich products but may contain meatball stuffed pizza sandwich products inside the package.  The problem was discovered when the firm received consumer complaints about products labeled as Mega Sandwich Pepperoni Stuffed Pizza that contained a meatball stuffed pizza sandwich product.

Monday, January 27, 2020

EU and US Agricultural Trade Talks - Removing the Barriers Not Easy

Currently, the EU has a trade surplus for agricultural goods.   The US would like to improve on this by getting more US food into the EU, but trade barriers, both tariffs by the EU on imported goods and regulatory barriers hamper this.

In a report published in the EU,  RISKS AND OPPORTUNITIES FOR THE EU AGRI-FOOD SECTOR IN A POSSIBLE EU-US TRADE AGREEMENT, many of these issues are laid out.  A few items that pop out is the impact from US meat production, as a low cost provider, the use of surface wash treatments used in US to meet requirements of the Pathogen Reduction Act, and the use of GMO materials.

NY Cheese Company Recalls Cotija Cheese (Queso Cotija) After State Lab Tests Show E. coli (STEC)

Quesos La Ricura LTD. of Hicksville, NY, is recalling 12 oz. packages of Cotija Cheese (Queso Cotija) after the Florida Department of Agriculture and Consumer Services discovered that a sample of the product was contaminated with Shiga toxin producing E. coli.  No injuries have been reported.  Product was distributed through retail stores in NY, NC, PA, GA, FL.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/quesos-la-ricura-ltd-recalls-cotija-cheese-queso-cotija-because-possible-health-risk
Quesos La Ricura LTD. Recalls Cotija Cheese (Queso Cotija) Because Of Possible Health Risk
Summary
Company Announcement Date: January 24, 2020
FDA Publish Date: January 24, 2020
Product Type: Food & Beverages Cheese/Cheese Product
Reason for Announcement: May be contaminated with Shiga toxin producing E. coli
Company Name: Quesos La Ricura
Brand Name: Quesos La Ricura
Product Description: Cheese

Friday, January 24, 2020

Novel Coronavirus Attracting Attention, Risk Considered Low

A lot of news coverage on the new, or novel, Coronavirus that originated in China.  Coronaviruses are a large family of virus that cause respiratory illness including the common cold with symptoms that are typically mild to moderate.

Novel forms of this virus can originate from time to time, strains evolving from animals and adapting to humans(this one may have originated in snakes),  Because the virus is new, it can take longer for the body to get it under control, and with that, it becomes more of a health issue.  But along with that, another factor is how quickly it spreads..how easily is it transmitted from person to person.

There is limited information on this current virus so far.  There have been approximately 830 cases reported so far, with 26 deaths.  Is it a huge risk...according to CDC, transmission has not been overly efficient, so the risk of a world wide pandemic is low....despite how much the main stream new media makes it seem.

My rendition of the corona virus.  The symptoms are dose dependent.

Oh, it's coronavirus, not corona virus.

https://www.cdc.gov/media/releases/2020/p0124-second-travel-coronavirus.html
Second Travel-related Case of 2019 Novel Coronavirus Detected in United States
Press Release
For Immediate Release: Friday, January 24, 2020
Contact: Media Relations
 (404) 639-3286

Two Importers Issued Warning Letters for Not Having FSVP

Two importers were issued Warning Letters by FDA for not having FSVP programs.  FDA is focusing more enforcement attention on food importers with the requirement for having a foreign supplier verification program (FSVP) as required as part of the FSMA regulation, specifically  21 CFR part 1 subpart.

Swagath Home Foods LLC of WA did not have FSVPs for for Black Pepper Powder imported from Subhash Masala Co. Pvt. Ltd., Spiced Chutney Powder imported from MTR Foods Pvt. Ltd., and Potato Chips imported from Pepsico India Holding Pvt.

Dinamix Distribution, LLC, was TX was not in compliance with the requirements of 21 CFR part 1 subpart L - did not have FSVPs for the following imported products: mayonnaise; tomatoes-spice flavored drink; and punch flavored soft drinks imported from (b)(4).

FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/swagath-home-foods-llc-594166-01072020
Swagath Home Foods LLC 
MARCS-CMS 594166 — January 07, 2020

Cornbread Dressing Product Recalled Due to Use of Recalled Eggs as Ingredient

Savannah Food Company, Inc., in a huge abundance of caution,  is recalling certain formulations of Cornbread Dressing and Bread Stuffing that included frozen diced eggs supplied to our company by Almark Foods, which were recalled due to Listeria.

With fully cook instructions on the cornbread dressing boxes, risk would be minimal.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/savannah-food-company-inc-voluntarily-recalls-cornbread-dressing-and-bread-stuffing-products-due
Savannah Food Company, Inc. Voluntarily Recalls Cornbread Dressing and Bread Stuffing Products Due to Possible Health Risk
Summary
Company Announcement Date: January 21, 2020
FDA Publish Date: January 23, 2020
Product Type: Food & Beverages  Prepared Food
Reason for Announcement:  Potential to be contaminated with Listeria monocytogenes
Company Name: Savannah Food Company, Inc.
Brand Name:  Morrison’s, Savannah Classics, Piccadilly
Product Description:  Cornbread Dressing and Bread Stuffing

Sandwich Company Expands Recall Again

Lipari Foods is yet again expanding its recall of Premo and Fresh Grab sandwiches due to potential contamination of Listeria monocytogenes.  The issue started when their supplier notified them. The initial recall was on January 6, 2020 and second on January 13, 2020 . 

This is a typical type of a scenario where a company finds that they never had Listeria under control.  They may have not had a sufficiently robust program to find it....doing testing, but not really looking for it.  Hard to say for sure what occurred, but further expansion of a recall is never what you want to see.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lipari-foods-issues-voluntary-recall-expansion-additional-sandwiches-due-potential-contamination-0
Lipari Foods Issues Voluntary Recall Expansion on Additional Sandwiches Due to Potential Contamination of Listeria Monocytogenes
Summary
Company Announcement Date: January 22, 2020 
FDA Publish Date: January 22, 2020 
Product Type:Food & Beverages Prepared Food Foodborne Illness 
Reason for Announcement:  Due to potential contamination of Listeria monocytogenes
Company Name:Lipari Foods
Brand Name:  Premo, Fresh Grab
Product Description:  Sandwiches

Thursday, January 23, 2020

More Tahina Recalled After Michigan Ag Finds Salmonella in Product

A Michigan company is recalling tahina (tahini) after the Michigan Dept of Ag tested and found product positive for Salmonella.  No illnesses have been reported.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/five-star-food-recalls-sham-gardens-excellent-tahina-because-possible-health-risk
Five Star Food Recalls Sham Gardens Excellent Tahina Because of Possible Health Risk
Summary
Company Announcement Date: January 15, 2020 
FDA Publish Date: January 21, 2020 
Product Type: Food & Beverages
Reason for Announcement:Foodborne Illness  Potential to be contaminated with Salmonella
Company Name: Five Star Food Inc. 
Brand Name: Sham Gardens
Product Description:  Tahina

Friday, January 17, 2020

Michigan Processor Agrees to Stop Production After Unable to Control Listeria

A Michigan food processor agreed to suspend operations after years of not being able to get compliant with regulation.   Home Style Foods of  Hamtramck, MI, a manufacturer of ready-to-eat seafood and deli salads, failed to get take sufficient corrective actions to get their Listeria monocytognes issues under control.  From the notice:
"According to the complaint filed with the consent decree, the FDA inspected the facility seven times between May 2009 and June 2018. During each inspection, the FDA investigators observed significant objectionable conditions. The FDA also found L. mono in the facility in two of the inspections, including the most recent inspection. The company was issued an FDA Form 483 after each of the seven inspections, was issued a warning letter in April 2016 and the company attended a regulatory meeting with the FDA in January 2017. The defendants repeatedly promised to take corrective actions to address the objectionable conditions. However, the FDA’s June 2018 inspection showed that the defendants have failed to take effective measures to bring Home Style Foods’ ready-to-eat food processing operations into compliance with the law."

FDA News Release
https://www.fda.gov/news-events/press-announcements/michigan-based-food-manufacturer-agrees-stop-production-after-repeated-food-safety-violations
Michigan-based food manufacturer agrees to stop production after repeated food safety violations
For Immediate Release:January 13, 2020

Sandwich Recall for Listeria Expanded

Lipari Foods expanded their recall of Premo and Fresh Grab sandwiches due to the potential for Listeria monocytogenes.  The recall comes after the supplier of those sandwiches, JLM Manufacturing expanded their recall.  The recall was initially made after environmental sampling returned a positive test result for Listeria monocytogenes.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lipari-foods-issues-voluntary-recall-expansion-additional-sandwiches-due-potential-contamination
Lipari Foods Issues Voluntary Recall Expansion on Additional Sandwiches Due to Potential Contamination of Listeria Monocytogenes
Summary
Company Announcement Date: January 13, 2020
FDA Publish Date: January 13, 2020
Product Type: Food & Beverages
Reason for Announcement:  Potential to be contaminated with Listeria monocytogenes
Company Name: Lipari Foods, LLC
Brand Name:  Premo,& Fresh Grab
Product Description:  Sandwiches

Wednesday, January 15, 2020

FDA Warning Letter to RTE Salad Processor

FDA issued a Warning Letter to a RTE Salad company after FDA's inspection found Listeria in the processing environment.  Accordingly, FDA's Warning Letter states that the facility's Preventive Control plan is not adequate.  They  did "not identify and implement a preventive control adequate to significantly minimize or prevent the hazard of the environmental pathogen L. monocytogenes from contaminating RTE produce in your facility".  Further, "did not implement your preventive control to prevent cross-contamination during washing. "

The validation of their process was also off the mark.   The facility "did not properly validate your preventive control for the use of (b)(4) to prevent cross-contamination. The study presented by your firm is titled “EPA Food Contact Sanitizer Test for Previously Cleaned Food Contact Surfaces (AOAC Germicidal and Detergent Sanitizing Action of Disinfectant) against Salmonella choleraesuis and Listeria monocytogenes.” That study pertains to food contact surfaces and was not designed to validate, nor is it adequate to validate, the antimicrobial efficacy of peracetic acid against pathogen cross-contamination during the produce washing process."

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/country-fresh-inc-591206-12122019
FDA WARNING LETTER
Country Fresh Inc.
MARCS-CMS 591206 — December 12, 2019

E.coli Outbreaks Linked to Salinas Romaine Declared Over, Investigation Continues

The FDA is lifting the consumer advisory to avoid romaine lettuce from Salinas growing region.  This is both E.coli outbreaks, one for the Romaine lettuce outbreak as well as the chopped Salad Kits.

"The FDA and CDC have been tracking two multi-state romaine lettuce outbreaks. Today, federal health officials are declaring both multi-state romaine lettuce outbreaks over. One of the outbreaks sickened 167 people in 27 states. The other outbreak, linked to Fresh Express salad kits, sickened 10 people in five states."

However, little has been determined on how the contamination events occurred.   The investigation continues.


https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-e-coli-romaine-salinas-california-november-2019
Outbreak Investigation of E. coli: Romaine from Salinas, California (November 2019)
Outbreak appears over; FDA investigation efforts continue
January 15, 2020

Recommendation
As of January 15, 2020, the CDC reports that the outbreak appears to be over. Contaminated romaine from the Salinas, CA growing region that made people sick in this outbreak is likely no longer available. Consumers need not avoid romaine lettuce, or any other produce, from the Salinas, CA growing area.
Case Counts

Total Illnesses: 167
 Hospitalizations: 85
 Deaths: 0
 Last illness onset: December 21, 2019
 States with Cases:  AZ (4), CA (8), CO (6), DE (1), FL (4), IA (1), ID (4), IL (15), MD (5), MI (2), MN (7), MT (1), NE (2), NJ (9), NC (3), NM (2), NY (3), OH (12), OR (1), PA (21), SC (1), SD (1), TN (1), TX (6), VA (6), WA (6), WI (35)


https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-e-coli-salad-mix-december-2019
Outbreak Investigation of E. coli: Salad Mix (December 2019)
Outbreak linked to Fresh Express brand Sunflower Crisp Chopped Salad Kits appears over
January 15, 2020


Recommendation

As of January 15, 2020, the CDC reports that the outbreak appears to be over.
Contaminated Fresh Express Sunflower Crisp Chopped salad kits that made people sick in this outbreak are likely no longer available on the market.

BPA Substitute in BPA-free Containers May Have Similar Concerns

A study out of the University of Guelph shows that a BPA-replacement chemical used in food packaging, named BPS or Bisphenol S may have similar effects to BPA.

BPA is a chemical used in plastic package manufacturing and there has been scrutiny of this chemical and its impact on health.  BPA has been eliminated from plastic used for baby bottle manufacturing.
"Because of the concern about its potential toxicity in humans, BPA is increasingly replaced by structurally similar chemicals, in particular bisphenol F (BPF) (4,4′-dihydroxydiphenyl-methane) and bisphenol S (BPS) (4,4′-sulfonylbisphenol), in the manufacturing of polycarbonates and epoxy resins."  However, surveys of urinary levels show that BPS is almost ubiquitous. {Lehmler, etal 2018

So BPA-free may not be much different than containers with BPA for those looking to avoid the packaging additive.

https://news.uoguelph.ca/2020/01/bpa-replacement-hinders-heart-function-u-of-g-study-reveals/
BPA Replacement Hinders Heart Function, U of G Study Reveals
Wednesday, January 8, 2020
BPA’s counterpart replacement BPS can hinder heart function within minutes of a single exposure, according to a new University of Guelph study.

Tuesday, January 14, 2020

MSG Added to Popular Chicken Sandwiches

The fast food chains are battling it out on the chicken sandwich front, and with news that McDonald is testing a new chicken sandwich, it was revealed that the top chicken sandwiches (Chick-fil-a and Popeyes) are using MSG - monosodium glutamate - as a flavor enhancer. Over the past years, MSG has garnered a bad reputation for causing headaches in people who are sensitive. It is also said to trigger migraines, those intense throbbing headaches that can last a day or so.

Many companies have removed MSG from their product labels years ago (although replaced by natural substitutes actually containing MSG), so it is surprising to find MSG in these popular chicken sandwiches.

MSG is naturally present in many foods and as an ingredient, it adds savory flavor or 'umami'. "Monosodium glutamate (MSG) is the sodium salt of the common amino acid glutamic acid. Glutamic acid is naturally present in our bodies, and in many foods and food additives"

FDA considers the addition of MSG to foods to be “generally recognized as safe” (GRAS). Although many people identify themselves as sensitive to MSG, in studies with such individuals given MSG or a placebo, scientists have not been able to consistently trigger reactions."

"FDA requires that foods containing added MSG list it in the ingredient panel on the packaging as monosodium glutamate. However, MSG occurs naturally in ingredients such as hydrolyzed vegetable protein, autolyzed yeast, hydrolyzed yeast, yeast extract, soy extracts, and protein isolate, as well as in tomatoes and cheeses. While FDA requires that these products be listed on the ingredient panel, the agency does not require the label to also specify that they naturally contain MSG. However, foods with any ingredient that naturally contains MSG cannot claim “No MSG” or “No added MSG” on their packaging. MSG also cannot be listed as “spices and flavoring.”

Meatingplace
https://www.meatingplace.com/Industry/News/Details/89734
Industry News - PM
Chicken sandwich wars may heat up as McDonald’s tests MSG
By Chris Scott on 1/14/2020

The ongoing tests of fried-chicken sandwiches by McDonald’s Corp. reportedly are being conducted with a flavor enhancer the fast-food giant does not use in its other food items: monosodium glutamate, more commonly known as MSG.

Friday, January 10, 2020

FDA Warning Letter for Importer Negligent of Having a FSVP Program for Layered Omelets

FDA issued a Warning Letter to an importer who was not in compliance with FSVP (Foreign Supplier Verification Program) for the frozen baked eggs/atsuyaki tamago manufactured by Ahjikan Co., LTD. (Shizuoka Factory), Japan.   The firm did not have a FSVP for this product.

The FSVP regulation requires that importers perform certain risk‐based activities  to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards.   More specifically, the company should have performed a hazard analysis on the frozen atsuyaki tamago product (a traditional Japanese multi-layered omelet).

So what hazards would one need to consider.  First, Salmonella if the product was not properly cooked.  Then, Listeria contamination would be a hazard to consider for potential cross contamination in the post-process environment.  Depending on what else the facility processed, allergens may also be a hazard requiring control.

WARNING LETTER
Kohyo America, Inc.

MARCS-CMS 593593 — December 23, 2019

This Week in Mislabeled Products for Week Ending January 11, 2020

Rookie Error - Missing the Anchovies in the Worcestershire Sauce - Carso’s Pasta Company, a Lynnwood, Wash. establishment, sold 636 pounds of ready-to-eat (RTE) Swedish meatball products that were misbranded. The products contain anchovies (fish), which are not declared on the product label. A recall was not requested because it is believed that the products are no longer available for consumers to purchase. The problem was discovered by FSIS during routine label verification activities.

Supplier Cross Contact Issue Results in Undeclared Dairy - Jeni’s Splendid Ice Creams has initiated a voluntary recall of three batches of Cold Brew with Coconut Cream Non-Dairy Frozen Dessert pints because they may contain an undeclared milk allergen. The recall was initiated following receipt of a single customer complaint of an allergic reaction. From the Recall Notice..."We have isolated the issue to the sorbet swirl in the flavor. Our investigation is ongoing, but we strongly suspect that a dry ingredient, used only in this flavor, came into contact with dairy powder as the dry ingredient was being produced for us in a partner’s facility.”

Wrong Package Results in Missed Walnut Allergen -
Purely Elizabeth is initiating a voluntary recall of their Chocolate Sea Salt Probiotic granola due to a mislabeling error that has resulted in an undeclared allergen (walnuts) being present. This recall has been initiated because it has come to their attention that briefly during production, pouches of Chocolate Sea Salt Probiotic Granola were used to package Maple Walnut Probiotic Granola. All mislabeled pouches of granola were packed into master cases labeled as 8oz Maple Walnut Probiotic Granola.

Wrong Label on Hearing in Cream Sauce - Ducktrap River of Maine of Belfast, Maine is announcing a voluntary recall of Herring Center Cuts in Wine Sauce identified with sell by date Jul 29, 2020 because these products contain undeclared milk due to an incorrect label. While the product in the containers is Herring Center Cuts in Cream Sauce, which contains milk, the containers were mistakenly labeled with the Herring Center Cuts in Wine Sauce labels. Ducktrap initiated the recall after discovering the labeling mistake. Subsequent investigation indicates that the issue is limited only to the specific lot identified above.

Consumer Finds Noodles In a Product with No Noodles
- Kettle Cuisine Midco, LLC, a Lynn, Mass. establishment, is recalling approximately 200 pounds of ready-to-eat (RTE) lentil and beef soup products due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The products contain egg and wheat. The problem was discovered when the company received a complaint from a consumer who reported finding noodles in their lentil and beef soup.

Wrong Package with Malted Balls Packed in Chocolate Covered Cashews Container
- Cargill is voluntarily recalling 39 one-pound bags of product incorrectly packaged as Wilbur Dark Chocolate Covered Cashews. Sold locally through the Wilbur Chocolate Store in Lititz, Penn., the bags are being recalled out of an abundance of caution because of a wheat allergen presence. Wilbur Dark Chocolate Malted Milk Balls were incorrectly labeled and packaged as Dark Chocolate Covered Cashews. The Malted Milk Balls contain wheat, which is not listed on the incorrect ingredient label. The Dark Chocolate Covered Cashews labels do, however, bear a “may contain wheat” statement.

Thursday, January 9, 2020

Tennessee Company Recalls Protein Snack Trays and Mixes that Used Recalled Hard Boiled Eggs Due to Listeria

Fresh Location, of Lenoir City, Tennessee is recalling Protein Snack Tray and Protein Trail Mix which both used hard boiled eggs recalled by Almark Foods for Listeria monocytogenes.  Almark issued their recall on December 23, 2019.





https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresh-location-announces-product-recall-due-possible-listeria-contamination
Fresh Location Announces Product Recall Due to Possible Listeria Contamination

Summary
Company Announcement Date: January 07, 2020
FDA Publish Date: January 08, 2020
Product Type:Food & Beverages Snack Food Item
Foodborne Illness Reason for Announcement: Potential to be contaminated with Listeria monocytogenes
Company Name:Fresh Location
Brand Name: Fresh Location
Product Description: Protein snack tray and protein trail mix

Deli Sandwiches Recalled After Environmental Sample Positive for Listeria

Lipari Foods has issued a voluntary recall of various Premo and Fresh Grab wedge sandwiches due to potential contamination of Listeria monocytogenes. This was brought to our attention by JLM Manufacturing after environmental sampling returned a positive test result for Listeria monocytogenes. 

The product looks to have at least 3 weeks shelf-life, plenty of time for Listeria to grow at refrigeration temperatures.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lipari-foods-issues-recall-various-wedge-deli-sandwiches-due-potential-contamination-listeria
Lipari Foods Issues Recall of Various Wedge Deli Sandwiches Due to Potential Contamination of Listeria Monocytogenes
Summary
Company Announcement Date: January 06, 2020
FDA Publish Date: January 06, 2020
Product Type:Food & Beverages
Reason for Announcement: Potential to be contaminated with Listeria monocytogenes
Company Name: Lipari Foods, LLC
Brand Name: Premo, Fresh Grab
Product Description: Wedge Sandwiches

Friday, January 3, 2020

This Week in Mislabeled Products for Week Ending January 4, 2020

Incorrect Packaging - Dianne's Fine Desserts of Newburyport, MA 01950 is recalling twenty six cases of product Sienna Turtle Brownie 8495241115 lot code 19198 , because it may contain undeclared peanuts. The recall was initiated after it was discovered that product containing peanuts was distributed in packaging that did not reveal the presence of peanuts. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company's production and packaging processes.

 Pine Nuts Missed on Label - J&J Distributing, a St. Paul, Minn. establishment, is recalling approximately 136 pounds of ready-to-eat salad products that contain meat due to misbranding and undeclared allergens,the products contain pine nuts (tree nut), a known allergen, which is not declared on the product label.   The problem was discovered during routine FSIS inspection activities.

Missed Allergens Result in Reactions - Whole Foods Market is voluntarily recalling 365 Everyday Value Dark Chocolate Peppermint Sandwich Cremes and 365 Everyday Value Dark Chocolate Caramel Sea Salt Sandwich Cremes because the products may contain undeclared milk or tree nuts (coconut),  Two reactions have been reported to date.

Imported String Cheese Recalled After Listeria Positive Test Result

A Palm Springs, FL. company, Limena, LLC, is recalling its 1 lb. (16 ounce) blocks of Salvadorean String Cheese (Quesillo Cheese) semi-soft cheese after routine testing by the Florida Department of Agriculture and Consumer Services revealed the presence of Listeria monocytogenes in one sample of 1 lb. (16 ounce) blocks of Salvadorean String Cheese (Quesillo Cheese). The recalled "Salvadorean String Cheese (Quesillo Cheese)" was distributed to retail stores and through mail orders.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/limena-llc-recalls-salvadorean-string-cheese-quesillo-cheese-because-possible-health-risk
Limena, LLC Recalls "Salvadorean String Cheese (Quesillo Cheese)" Because of Possible Health Risk
Summary
Company Announcement Date: January 02, 2020
FDA Publish Date: January 02, 2020
Product Type: Food & Beverages Cheese/Cheese Product
Reason for Announcement:Potential to be contaminated with Listeria monocytogenes
Company Name: Limena, LLC
Brand Name: Limena, LLC
Product Description: Salvadorean String Cheese (Quesillo Cheese) semi-soft cheese

Thursday, January 2, 2020

Sprouts Recalled After Potentially Linked to E. coli Outbreak

Sprouts Unlimited of Marion IA is recalling clover spouts in 4 oz packages because it may be contaminated with Escherichia coli O103 bacteria (E. coli O103)after receiving information from the Iowa Department of Inspections and Appeals, Des Moines, IA that a cluster of E. coli O103 illnesses epidemiologically linked to clover sprouts from Sprouts Unlimited Inc

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sprouts-unlimited-inc-recalling-clover-sprouts-4-ounce-packages-due-possible-health-risk
Sprouts Unlimited Inc. is Recalling Clover Sprouts in 4-ounce Packages Due to a Possible Health Risk

Summary
Company Announcement Date: December 27, 2019
FDA Publish Date: December 27, 2019
Product Type: Food & Beverages Vegetable Products
Reason for Announcement: May be contaminated with Escherichia coli O103 bacteria
Company Name: Sprouts Unlimited\
Brand Name: Sprout Unlimited
Product Description: Clover Sprouts

Review Article - Growth and Survival of Listeria monocytogenes on Intact Fruit and Vegetable Surfaces during Postharvest Handling: A Systematic Literature Review

Does LM grow on the surfaces of produce?  A review article in the Journal of Food Protection surveyed research on the topic and provides insight into factors that affect growth on the surface including moisture, topography, nutrient availability, and microflora.   Some key items from the discussion:

FDA Update on the Salmonella Outbreak Associated with Fresh Cut Produce

FDA provided an update on the Salmonella outbreak associated with Tailor Cut Produce Fruit Mix.  The initial announcement in early December occurred when 31 cases of salmonellosis were identified in 4 Pennsylvania healthcare facilities.  FDA now reports 96 cases in 11 states with a high concentration of cases in PA, DE, and NJ.  The last onset case was on December 10, 2019.  "The firm recalled the fruit mix, called Fruit Luau, as well as cut honeydew, cut cantaloupe and cut pineapple products on December 7".

https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-salmonella-javiana-potentially-linked-tailor-cut-produce-fruit-mix-winter
Outbreak Investigation of Salmonella Javiana Potentially Linked to Tailor Cut Produce Fruit Mix, Winter 2019
FDA’s investigation continues. Food service companies and institutions should not serve recalled products

Case Counts
Total Illnesses: 96
Hospitalizations: 27
Deaths: 0
Last illness onset: December 10, 2019
States with Cases: CA, CO, CT, DE (39), IL, MN, NJ (12), NY (4), PA (34), VA, WA
January 2, 2020

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

Wednesday, January 1, 2020

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