CDC Report - 2017 E. coli Outbreak Associated with Soy Nut Butter

 CDC released a report detailing the 2017 E. coli outbreak of E. coli O157 linked to soynut butter that resulted in 32 cases from 12 states with twenty-six (81%) cases occurred in children ( <18 years old) and with 8 of those children developing hemolytic uremic syndrome (impacting kidney function).

The facility had multiple issues as was detailed in the FDA 483 report. although the ultimate ingredient source was not identified.

Items of note from the report:

• The was the first time a peanut butter alternative such as soy nut butter has been implicated as the source of an outbreak of STEC infections in the United States
• More than one-quarter of the case patients developed HUS, and all but 1 were children <18 years old.  
• CDC identified a subcluster in an Oregon child care center where secondary transmission might have contributed to the spread of the outbreak -this serves as a reminder to child care providers of the importance of appropriate hand-washing and hygiene practices to prevent the spread of infections in these settings and that children with STEC O157 infection should be excluded from attending child care centers until 2 stool cultures (obtained at least 48 hours after antimicrobial therapy, if given, has been discontinued) have negative results for STEC.
• This outbreak serves as a reminder of the important role manufacturers play in preventing foodborne outbreaks and the role brand owners have in overseeing their product safety. Soy nut butter is a ready-to-eat food with a long shelf life, and multiple foodborne outbreaks have been identified over the past few years linked to other ready-to-eat, long-shelf-life foods, such as a powdered meal replacement product, sprouted nut butters, and chia powder.
• Product contamination may have occurred through use of a contaminated ingredient or cross-contamination from contact with contaminated equipment or surfaces during manufacturing. However, because ingredient sample results were negative and multiple objectionable conditions were identified during the facility’s inspection, it was not possible to determine which specific route led to product contamination.

https://pediatrics.aappublications.org/content/early/2019/09/12/peds.2018-3978
A Multistate Outbreak of E Coli O157:H7 Infections Linked to Soy Nut Butter

This Week in Allergen Related Recalls for Week Ending September 21, 2019

Chicken Meal With Soy Ingredient Labeled as Beef Meal Astrochef LLC., a Rockwall, Texas establishment, is recalling approximately 11,475 pounds of frozen chicken pub style entrees labeled as beef pub style entrees due to misbranding and undeclared allergens, the product contains soy, a known allergen, which is not declared on the product label.  The problem was discovered when Conagra Brands received consumer complaints reporting that the product was incorrectly labeled.

Cake Item with Egg Mislabeled as Lemon Dessert Bars with No Egg - .Schwartz Brothers Bakery of Seattle, WA is recalling 24 units of Lemon Dessert Bars, sell by date 09/21/19, because it may contain undeclared Egg.  The recall was initiated after it was discovered that some of the Lemon Pound Cake, which contain Egg, was mislabeled as Lemon Dessert Bars. The Lemon Dessert Bars label does not declare Egg.

Wrong Product Labeled as Gluten Free Product - Perdue Foods, LLC, a Perry, Ga. establishment, is recalling approximately 495 pounds of frozen ready-to-eat chicken products due to misbranding and undeclared allergens, the product contains wheat, a known allergen, which is not declared on the product label. The frozen ready-to-eat chicken products are labeled as gluten free chicken breast tenders but contain chicken nugget products. The problem was discovered when the company notified FSIS that they received two consumer complaints regarding the mislabeled product.

Peanut Butter Cookies Do Contain Peanut - Southeastern Grocers (SEG), the parent company of BI-LO, Fresco y Más, Harveys Supermarkets and Winn-Dixie stores, is issuing a voluntary recall for two 18-count cookie products sold in the bakery due to the inclusion of an undeclared allergen in the products.  The 18-count Variety Pack containing Peanut Butter Cookies and the 18-count Peanut Butter Cookie did not include peanut ingredients on the label.

Bags of Flour Recalled After Sample Test Positive for E. coli

General Mills announced today a voluntary national recall of five-pound bags of its Gold Medal Unbleached All Purpose Flour with a better if used by date of September 6, 2020. The recall is being issued for the potential presence of E. coli O26 which was discovered during sampling of the five-pound bag product.  No illnesses have been reported.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/general-mills-recalls-five-pound-bags-gold-medal-unbleached-all-purpose-flour
General Mills Recalls Five Pound Bags of Gold Medal Unbleached All Purpose Flour

Summary
Company Announcement Date:  September 16, 2019
FDA Publish Date:  September 16, 2019
Product Type:  Food & Beverages
Reason for Announcement:  E. coli O26
Company Name:  General Mills
Brand Name:  Gold Medal
Product Description:  Unbleached All Purpose Flour

Producer of Ultra-fresh, Organic Meals is Recalling Salads After Spinach Supplier Has E. coli Positive Samples

A California-based food company, self-described as a producer of ultra-fresh, organic meals,  is voluntarily recalling 76 salads and wraps that contain spinach that may be contaminated with E. coli.  Spinach from a supplier tested positive for a 'small amount' of Escherichia coli (E. coli) bacteria.  Urban Remedy will no longer buy spinach from that supplier.  At this point, the product has already exceeded it's shelf-life date. 

Not sure whether it was pathogenic E. coli or generic E. coli.  Not sure what constitutes 'a small amount.'  Not really sure what differentiates fresh from ultra-fresh.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/urban-remedy-voluntarily-recalls-76-salads-wraps-may-contain-ecoli-bacteria-no-illnesses-reported
Urban Remedy Voluntarily Recalls 76 Salads, Wraps That May Contain E.Coli Bacteria No Illnesses Reported, Company Taking Preventive Action

Summary

Company Announcement Date:  September 12, 2019

FDA Publish Date:  September 13, 2019

Product Type:  Food & Beverages Prepared Food

Reason for Announcement:  may be contaminated with E. coli

Company Name:Urban Remedy

Brand Name: Urban Remedy

Product Description: Salads and Wraps

This Week in Allergen Related Recalls for Week Ending September 14, 2019

NY Ag and Markets Test Finds Undeclared Milk Allergen in Sports Drink - Stark Group International of Greenvale, NY is recalling all codes of its 100 gram packages of Ritter Sport -KAFFEESPLITTER because they may contain undeclared milk allergens.  The recall was initiated after routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis by Food Laboratory personnel revealed the presence of undeclared milk allergens in the 3.5 ounce/100 gram packages of Ritter Sport– KAFFEESPLITTER which did not declare a milk ingredient on the label.

FSIS Inspector Discover Missing Milk on Label Hy-Vee Fresh Commissary, an Ankeny, Iowa establishment, is recalling approximately 6,233 pounds of ready-to-eat (RTE) beef and chicken products due to misbranding and undeclared allergens - the products contain milk, a known allergen, which is not declared on the product label.  The problem was discovered during FSIS in-plant verification activities.

Internal Testing Finds Gluten in Gluten Free Product - Hometown Food Company today initiated a limited, voluntary, consumer-level recall of approximately 374 cases of two specific lot codes of its Martha White Gluten Free Sweet Cornbread Muffin Mix, due to standard quality batch testing that indicated the presence of gluten derived from wheat, rye, barley, or crossbreeds of these grains.

NY Ag and Markets Test Finds Undeclared Milk Allergen - Rong Shing of Brooklyn, NY is recalling 1) its 450g packages of FuPaiYuan Nougat candy amd 2) 450g packages of FuPaiYuan Matcha  candy because both products may contain undeclared eggs and milk allergens  The recall was initiated after routine sampling be New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis by Food Laboratory personnel revealed the presence of undeclared eggs and milk in the products which did not declare eggs and milk ingredient on the label.

CDC Updates Reported Cases of Hepatitis A Across Country

CDC updated their information on the nationwide Hepatitis A outbreak.  In August of this year, CDC reported 24, 280 cases.   Since that time, 1,200 more cases have been recorded, with the total at 25,484.

Interesting, California, one of the first states to report (and has a huge homeless population), had declared their outbreak over in 2018.

https://www.cdc.gov/hepatitis/outbreaks/2017March-HepatitisA.htm
Widespread person-to-person outbreaks of hepatitis A across the United States

At A Glance
Since the outbreaks were first identified in 2016, 30 states have publicly reported the following as of September 6, 2019

• Cases: 25,484
• Hospitalizations: 15,330 (60%)
• Deaths: 254

FDA Warning Letter Issued to MA Bakery for Being Nasty

FDA issued a Warning Letter to a Massachusetts bakery, a manufacture of Peggy Lawton Ready-to-Eat (RTE) bakery products, including cookies and brownies.  It seems like this operation checked all the boxes on inspection sheet.  This operation has been operating for over 60 years doing it they way they have always done it.  A write-up in the Boston Globe discusses the company and their success and challenges.  It can be guessed that because they do not sell into larger chains, there was probably never a third party audit conducted.  Keeping low key has allowed them to stay under the radar...unfortunately for their customers.

"FDA determined that "the RTE food products manufactured in your facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)] in that they were prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of part 117) is prohibited by Section 301(uu) of the Act [21 USC 331(uu)]."

• No Preventive Control Plan 
• Potentially contaminating product with raw flour (which we know can contain Salmonella) -  empty bags of raw flour were observed placed over racks of ready-to-eat brownies and in direct contact with the pans of cooling brownies
• Improper maintenance - tape is not acceptable for fixes - multiple layers of electrical tape were observed wrapped around a cookie die. The cookie dough is pressed out of the die to make dough in the shape of cookies.
• Improper surfaces for holding RTE product - ready-to-eat brownies were observed placed onto mats prior to being sliced. Areas of the mats appeared to be porous, and the ends of the mats were frayed.
• Unsanitary cleaning equipment - a wire brush duct taped to a wooden pole was observed being used to remove cookie crumbs from the chain conveyor located before the first cooling tunnel. The duct tape was frayed, and there was as an accumulation of apparent food residue on the handle of the wire brush and duct tape and on the bristles of the wire brush.
• Inadequately cleaned transfer containers -  the gray totes used for holding brownie scraps were observed to have an accumulation of apparent food residue on the inside of the tote that comes into direct contact with the brownie scraps that are used to manufacture brownies.
• Non-approved sanitation chemicals and poor cleaning practices- the agent used for cleaning and sanitizing food contact surfaces consists (b)(4), Production employees were observed using this mixture of (b)(4) to wipe down food contact equipment including brownie mats, round blades for slicing brownies, brownie packing line conveyor belts, and the conveyor belts on the cookie line.
• Backflow devices needed on hoses - a hose at a two-bay sink was connected to a drum containing floor cleaner. The hose was equipped with a shut off valve where the hose connects to the drum. The hose lacked an appropriate backflow prevention device.
• Inadequate hand washing stations -  the hand washing sinks located in the cookie packing room were observed to not be operating from May 28, 2019 – May 30, 2019. Additionally, the sink located in the ingredient prep area and the sink located between the dishwasher and floor cleaner dispenser were not equipped with hand sanitizer.
• Unsanitary employee clothing - an employee working in the brownie mixing area was observed to have heavily soiled pants at the beginning of the production day (approximately 5:35 AM) and the employee’s clothing became increasingly more soiled throughout the work day. The employee's soiled pants were observed coming into direct contact with the edge of the depositor hopper each time they leaned over the brownie depositor hopper as they scraped the contents of the brownie batter mixing bowl into the depositor hopper.
• Improper sanitation procedures - the equipment used to manufacture brownie batter was cleaned with water only; the cleaning did not include the use of detergent, physical scrubbing, and a sanitizer.
• Potential cross contamination issues - an employee was observed removing sheet pans of cooked brownies and placing them on a rack immediately beneath sheets pans of uncooked brownies. Additionally, your firm uses the same oven racks for holding sheet pans of uncooked brownies prior to placing the sheet pans in the oven and for holding pans of cooked brownies after they are baked. The brownie racks, which are not placed in the oven, are cleaned every (b)(4) to (b)(4) and were observed to be soiled with apparent uncooked brownie batter and cooked brownie particles.
• Improper dishwasher usage - the dishwasher is loaded along with water and detergent at the beginning of the day. This water/detergent mixture is recycled all day and is not discharged until the end of the day. Additionally, the dishwasher does not utilize a chemical sanitizing agent. The highest temperature achieved during a complete wash cycle according to the temperature monitoring probe on the dishwasher was observed to be 142 °F.
• Inadequate hand washing by employees - numerous occasions identified where employees did not wash their hands as they should have. (see item #9)
• Probable allergen cross contact - the last batch of cookies manufactured on May 28, 2019, consisted of Chocolate Chip Cookies (which contain walnuts), and the first batch of cookies manufactured on the same equipment on May 30, 2019 (the next day of manufacturing), were Oatmeal Cookies (which do not contain walnuts). The equipment was inspected at the end of the day on May 28, 2019, but on May 30, 2019, prior to manufacturing the Oatmeal Cookies, cookie and cookie residue were observed on the chain conveyors, turn tables, cookie magazines, and cookie chutes. You stated the last time the conveyors were cleaned was January 2019.
• Improper bulk storage with the potential for contamination -  an exposed bulk size (b)(4) was observed stored on top of unopened cardboard boxes (b)(4).
• Floors inadequately cleaned and maintained - The flooring near the brownie mixing station and brownie oven was observed to have an accumulation of apparent food residue and grime after cleaning was conducted on May 29, 2019. Additionally, floor tiles were observed in disrepair with an accumulation of apparent food residue and grime in the production area.
• Standing water, a big no-no in dry operations due to microbial proliferation - Water was observed pooling over the floor drain where brownie packing operations are conducted and where employees stand and walk when packaging brownies. Additionally, pooling water was observed in an area along the wall near the shortening dispenser in the brownie batter prep area. 
• Rust and flaking paint - Paint was observed to be peeling and chipping along the wall behind the flour sifter where opened buckets of flour were held.  And the door frames to the humidifier tunnel contained apparent rust and flaking paint.
• No training records - did not have records documenting training in the principles of food hygiene and food safety for employees who manufacture, process, pack, or hold brownies

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peggy-lawton-kitchens-inc-586321-08292019

WARNING LETTER

Peggy Lawton Kitchens, Inc.
MARCS-CMS 586321 — 

August 29, 2019

Imported Spice Packets Recalled After FDA Sampling Finds Salmonella

House of Spices, an Indian food specialty company, is recalling its Sambar Masala spice after FDA had tested and found that the product was positive for Salmonella.  Based on the picture of the packaged which was posted on the FDA website, the product was sourced from the Middle East.

As part of the requirements, the importer of this product, House of Spices, would have been required to have a FSVP, or Foreign Supplier Verification Program in place, and as part of that program, measures in place to ensure that the supplier of this product had controls for hazards.   And with spices, Salmonella would be a potential hazard.  These measures could include:

• requiring a COA for each lot with sampling and testing from a reputable laboratory, 
• an onsite audit to ensure that 1) spices are being properly treated and 2) the facility had controls to protect against environmental contamination in mixing and packing areas
• the importers own testing protocol which would check incoming lots and serve as a verification of the COA.  One would be looking at large sample quantities (375 g rather than 25g) over multiple units within the lot. 

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/house-spices-india-issues-recall-mdh-sambar-masala-due-salmonella-contamination
House Of Spices (India) Issues Recall of "MDH Sambar Masala" Due To Salmonella Contamination
Summary
Company Announcement Date: September 07, 2019 

FDA Publish Date:September 07, 2019 

Product Type: Food & Beverages 

Reason for Announcement: Salmonella
Company Name: House Of Spices India 

Brand Name: MDH
Product Description:  MDH SAMBAR MASALA

Hamburger Buns Recalled After Dough Scrapper Gets 'Incorporated' into Dough

Conagra Brands is voluntarily recalling approx. 2,200 cases of Udi’s Classic Hamburger Buns due to the potential presence of small pieces of white plastic. "The company discovered the issue which occurred when a dough scraper was inadvertently incorporated into the production process for a small amount of the product."  'Inadvertently incorporated' could mean accidently dropped, left in mixer after use, etc.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/udis-classic-hamburger-buns-recalled-due-potential-presence-foreign-material
Udi’s Classic Hamburger Buns Recalled due to Potential Presence of Foreign Material
Summary
Company Announcement Date: September 06, 2019
FDA Publish Date: September 06, 2019
Product Type: Food & Beverages
Reason for Announcement: Foreign Object White Plastic
Company Name:Conagra Brands
Brand Name: Udi's
Product Description:  Classic Hamburger Buns