FDA on Steps for the Safety of Imported Goods from China Considering Coronavirus

The US imports a lot of goods from China and of course, people are concerned about this fact regarding Coronavirus.  FDA released a statement indicating that there is no perceived issue at this time.

"Fortunately, currently, we are not seeing the impacts of this outbreak resulting in an increased public health risk for American consumers from imported products. There is no evidence to support transmission of COVID-19 associated with imported goods and there have not been any cases of COVID-19 in the United States associated with imported goods. As noted, this remains a dynamic situation and we will continue to assess, and update guidance as needed. "

 "We also continue to aggressively monitor the market for any firms marketing products with fraudulent COVID-19 prevention and treatment claims. The FDA can and will use every authority at our disposal to protect consumers from bad actors who would take advantage of a crisis to deceive the public, including pursuing warning letters, seizures, or injunctions against products on the market that are not in compliance with the law, or against firms or individuals who violate the law."

As an enveloped virus, it will not last as long as a non-enveloped virus such as Norovirus.

https://www.fda.gov/news-events/press-announcements/coronavirus-update-fda-steps-ensure-quality-foreign-products
Coronavirus Update: FDA steps to ensure quality of foreign products
For Immediate Release:
February 24, 2020

Is it Worth Wearing Masks to Prevent Coronavirus?

There has been a rush to purchase surgical masks to prevent Coronavirus.  In short, it is not going to do much and thus not worth the effort.  Surgical masks prevent the wearer from spewing out droplets, but are not overly efficient at the reverse.    So it would be recommended for someone who may have been exposed, but not for someone who is just trying to prevent illness, especially in places like the US where it is a low risk.

Healthcare workers working with potentially ill person from Coronavirus are advised to wear a heavy-duty mask called an N95 respirator.   "These respirators are designed to fit tightly around the nose and mouth, and, when worn correctly, block out at least 95% of small airborne particles, according to the CDC."  But these are not something recommended for the general public.

https://www.businessinsider.com/wuhan-coronavirus-face-masks-not-entirely-effective-2020-1
People are racing to buy face masks amid the coronavirus outbreak, but they probably won't protect you from illness
Holly Secon Feb 26, 2020, 2:45 PM

This Week in Mislabeled Product for Week Ending February 29, 2020

Wrong Formulation Adds Milk Chocolate Chips - Choice Products USA, LLC of Eau Claire, WI, is recalling 275 - 3lb tubs of Peanut Butter Cookie Dough, because it may contain undeclared milk from milk chocolate chips. Some containers of the 3lb. Peanut Butter Cookie Dough have been found to contain milk chocolate chips which were mistakenly included in the mixing process of the Peanut Butter Cookie Dough. The recall was initiated after it was discovered that product containing milk chocolate chips was distributed in packaging that did not reveal the presence of milk. Subsequent investigation indicates the problem was caused by an inadvertent adherence to the company's “production and packaging procedures."

Pasta Contains Gluten and Cannot Be Called Gluten Free- Sierra Soups of Fresno, Ca is recalling its 13 ounce packages of "Pasta e Fagioli" because the soup mix contains an individually wrapped package of pasta, which contains gluten. However outer packaging states the product is Gluten Free.   The recall was initiated after it was discovered that the gluten-containing product was distributed in packaging that did not clearly reveal the presence of gluten. Subsequent investigation indicates the problem was caused by a breakdown in the company's packaging processes.

Milk Missing from Label - Moonstruck Chocolate Co. of Portland, Oregon is recalling 1,500 / 3.1 oz. Praline Pecan & Ginger Element Bar in Dark Chocolate, 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 list the presence of milk.

Peanut and Almond Mix-up? Vitamin Cottage Natural Food Markets, Inc., a Lakewood, Colorado-based natural grocery chain, is recalling Natural Grocers brand 8 ounce Almond Clusters Dark Chocolate Non-GMO because the product contains undeclared peanut allergen and they are recalling Natural Grocers brand 8 ounce Peanut Clusters Dark Chocolate Non-GMO because the product contains undeclared almond allergen

FDA Issues Warning Letters To Two Importers for No FSVP

FDA issued Warning Letters to two importers for not having Foreign Supplier Verification Programs in place for their international suppliers.

• Banjaras Inc of Texas did not have a FSVP in place for suppliers of coriander and garlic, Rasam powders, Kesar mango pulp and Suji rusk.
• Hindy Import Inc. of Cajon, CA did not have a FSVP for suppliers of red lentils, bulgur coarse with vermicelli noodles, and vermicelli noodles, and white quinoa.

Whether a company is directly importing product or if they are using importers to bring in product, someone must be responsible for evaluating the safety of that product. While manufacturers who directly import food or ingredients can do that as part of their Preventive Controls plan, if they are using an importer, then it is critical to understand who has a program in place to evaluate and ensure the safety of that product. For food manufacturers, they often assume the broker is covering the regulatory requirements, but without delineating that on a contractual basis, one does not know for certain.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/banjaras-inc-589115-09252019
FDA WARNING LETTER
Banjaras Inc
MARCS-CMS 589115 — September 25, 2019

Allergen Related Recall Triggers FDA Inspection that Results in Warning Letter

FDA issued a Warning Letter to a Wisconsin ice cream facility for an inspection that was initiated  after a company-issued recall when the company packed Bourbon Honey Pecan Ice Cream into Gluten Free Cookies N Cream ice cream containers (gluten and tree nut allergens into a package with a gluten-free label and no nuts listed).

The firm was cited for not having adequate allergen controls to prevent a recall, specifically actions to prevent improper packaging with allergen declarations.  They were also cited for not implementing their sanitation controls systems including corrective action and verification.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sassy-cow-creamery-llc-587954-12042019
WARNING LETTER
Sassy Cow Creamery, LLC 
MARCS-CMS 587954 — December 04, 2019

FDA Issues Warning Letter to Sandwich Chain for Series of Outbreaks and Sprouter for Issues Leading to Outbreak

FDA issued Warning Letters to both Jimmy John's and a sprout distributor in light of a series of outbreaks associated with the chain.  The investigation "lays out evidence from five outbreaks, including the most recent outbreak in the state of Iowa during November and December 2019, of human infections with Escherichia coli O103, a Shiga toxin producing Escherichia coli (STEC)."

A bit of this announcement seems to be grandstanding for FDA's new movement, the "New Era of Smarter Food Safety".  In this news release for the action against Jimmy Johns, it goes on to state "The FDA is currently developing a Strategic Blueprint that will outline how the agency plans to leverage technology and other tools, to create a more digital, traceable and safer food system. This work will build on the advances that have been and are being made in the FDA’s implementation of the Food Safety Modernization Act to further strengthen prevention of foodborne illnesses."

So while the letter against Jimmy John's is based on outbreaks linked to the restaurant chain, the letter against the Iowa sprouter is after an invetigation associated with the an "outbreak of human infections with Shiga toxin-producing Escherichia coli O103 (E. coli O103) that sickened 22 people between November 21 and December 14, 2019."

1.  Did not test spent sprout irrigation water (SSIW) from each production batch of sprouts for E. coli O157:H7 and Salmonella, as required by 21 CFR 112.144(b). 
2.  Did not take steps to hold all product from entering commerce before receiving results from the spent sprout irrigation water tests, as required by 21 CFR 112.147(
3. Did not take corrective actions when environmental samples of your growing, harvesting, pack

FDA In Brief: FDA Issues Warning Letters to Jimmy John’s and a Sprout Distributor for Food Safety Violations
February 25, 2020

New Consumer Product for Sanitizing Surfaces Released

P&G introduced a new surface sanitizer, Microban 24, a Quaternary Ammonium based sanitizing solution.  It is important to note that this is not designed for food contact surfaces, at least not without rewashing the surface after application and before use.

So, how important is it to have the residual sanitizing affect on a non-food contact surface?  Do you want to have chemicals left on the surface or is having clean surface enough?

While it comes at a time when Coronavirus, Covid-19, is on everyone's mind, the product has not been tested against that specific virus, so it can't make that specific claim.

Asked about Microban 24’s use as a guard against the 2019 novel coronavirus (Covid-19), the spokeswoman responded carefully, noting that because it’s a new strain, “there is not yet an acceptable EPA method for claims against it.” 

But it is claimed that it has been found effective against similar viruses.

Microban 24 Product Description
Microban 24-Hour Disinfectant Sanitizing Spray, Citrus, 15 oz - Microban provides 24-hour sanitization against bacteria even after multiple touches. Kills 99.9% of bacteria in 5 minutes, and keeps killing for 24 hours. Cleans and sanitizes in one step. Suitable for everyday use. Aerosol Sanitizing Spray suitable for use on hard surfaces and non-washable soft surfaces like upholstery, backpacks, luggage, curtains and cushions.

• Provides 24-hour sanitization against bacteria even after multiple touches.
• Kills 99.9% of bacteria in 5 minutes, and keeps killing for 24 hours.
• Cleans and sanitizes in one step.
• Suitable for everyday use on hard surfaces and non-washable soft surfaces like upholstery, backpacks, luggage, curtains and cushions.

This Week in Mislabeled Products for Week Ending February 22, 2020

Cheddar Chips in Wrong Labeled Bag Results in Milk Allergen Miss -  Saratoga Potato Chips, llc of Fort Wayne, Indiana is recalling 140 cases of Kroger Sweet & Mesquite BBQ Potato Chips 17 oz (UPC 0111100320101) with the specific lot code because it may contain undeclared milk.  The issue was discovered when some consumers reported finding cheddar cheese flavored chips in the Bag of Sweet & Mesquite BBQ Potato Chips

Product With Peanut Gets Wrong Labeled Sleeve -  Containing Peanuts Mislabeled - CJ Foods, Inc., a division of CJ America, Inc., of La Palma, CA, is voluntarily recalling Annie Chun’s Japanese-Style Teriyaki Noodle Bowls because it may contain undeclared peanuts. The voluntary recall was initiated because the company discovered some bowls that were packaged in outer sleeves indicating Teriyaki Noodle Bowls contain Pad Thai noodle, which contains peanuts that are not listed on the ingredient list or allergen information.

Study - Growth and Survival of Vegetative Pathogens in Beef and Plant (Fake Beef) Burgers

Not that we would expect to have high levels of vegetative pathogens (STEC, E. coli, Listeria, and Salmonella) in plant-based burgers, but we would consider the risk of them being there should be low, with the possible exception of Listeria.  However, the plant-based burgers are a TCS food (they have the necessary nutrients, Aw and pH) and thus will support the growth of organisms during storage. 

Storage at refrigeration and slight temperature abuse situations - At slight temperature abuse temperatures (10C), the levels of all three pathogens increased by ca. 1.0 to ca. 2.5 log CFU/g in plant-based burgers (beef burgers showed a slight decrease).
Cooking - all pathogens were reduced equally well in plant-based burgers and regular burgers.

Key - need to treat plant based burgers like regular burgers, especially regarding storage temperatures.

Viability of Shiga Toxin–Producing Escherichia coli, Salmonella, and Listeria monocytogenes within Plant versus Beef Burgers during Cold Storage and following Pan Frying 
JOHN B. LUCHANSKY ;  BRADLEY A. SHOYER  ;  YANGJIN JUNG  ;  LAURA E. SHANE  ;  MANUELA OSORIA  ;  ANNA C. S. PORTO-FETT
J Food Prot (2020) 83 (3): 434–442.
https://doi.org/10.4315/0362-028X.JFP-19-449

ABSTRACT

The viability of Shiga toxin–producing Escherichia coli (STEC), Salmonella, and Listeria monocytogenes within plant- and beef-based burgers was monitored during storage and cooking. When inoculated (ca. 3.5 log CFU/g) into 15-g portions of plant- or beef-based burgers, levels of STEC and Salmonella decreased slightly (≤0.5-log decrease) in both types of burgers when stored at 4°C, but increased ca. 2.4 and 0.8 log CFU/g, respectively, in plant-based burgers but not beef-based burgers (≤1.2-log decrease), after 21 days at 10°C. For L. monocytogenes, levels increased by ca. 1.3 and 2.6 log CFU/g in plant burgers after 21 days at 4 and 10°C, respectively, whereas pathogen levels decreased slightly (≤0.9-log decrease) in beef burgers during storage at 4 and 10°C. Regarding cooking, burgers (ca. 114 g each) were inoculated with ca. 7.0 log CFU/g STEC, Salmonella, or L. monocytogenes and cooked in a sauté pan. Cooking plant- or beef-based burgers to 62.8°C (145°F), 68.3°C (155°F), or 73.9°C (165°F) delivered reductions ranging from ca. 4.7 to 6.8 log CFU/g for STEC, ca. 4.4 to 7.0 log CFU/g for L. monocytogenes, and ca. 3.5 to 6.7 log CFU/g for Salmonella. In summary, the observation that levels of all three pathogens increased by ca. 1.0 to ca. 2.5 log CFU/g in plant-based burgers when stored at an abusive temperature (10°C) highlights the importance of proper storage (4°C) to lessen risk. However, because all three pathogens responded similarly to heat in plant-based as in beef-based burgers, well-established cooking parameters required to eliminate STEC, Salmonella, or L. monocytogenes from ground beef should be as effective for controlling cells of these same pathogens in a burger made with plant-sourced protein.

Study - Prevalence of Salmonella and STEC E. coli in Pork Products

A study conducted by FSIS looked at the prevalence of Salmonella and STEC E. coli in pork products.  Analysis "determined that the national prevalence of Salmonella in raw pork products was highest in comminuted products (28.9%), followed by intact cuts (5.3%) and nonintact cuts (3.9%). Less than 1% of samples analyzed were positive for the top seven STEC. Our findings indicate there is a need for additional pathogen reduction strategies for raw pork products."

Journal of Food Protection
Volume 83, Issue 3
1 March 2020
https://meridian.allenpress.com/jfp/article/83/3/552/426177/Salmonella-and-Shiga-Toxin-Producing-Escherichia
Salmonella and Shiga Toxin–Producing Escherichia coli in Products Sampled in the Food Safety and Inspection Service Raw Pork Baseline Study 
MARIA E. SCOTT;  EVELYNE MBANDI ;  STEPHANIE BUCHANAN ;  NASER ABDELMAJID  ;  CHRISTIAN GONZALEZ-RIVERA;  KIS ROBERTSON HALE;   LISA JACOBSEN ;   JENNIFER WEBB;  JENNIFER GREEN ;  PAUL DOLAN 

ABSTRACT
The Food Safety and Inspection Service (FSIS) conducts microbiological baseline studies to determine national prevalence of select foodborne pathogens in federally inspected meat and poultry products and to obtain data for risk assessments. The FSIS conducted a baseline study from 1 June 2017 through 31 May 2018 to characterize and determine the prevalence of Salmonella and assess the occurrence of Shiga toxin–producing Escherichia coli (STEC) in a variety of raw pork products. In total, 4,014 samples from slaughter and processing establishments were analyzed for Salmonella; a subset of these samples (1,395) from slaughter establishments were also analyzed for STEC. Analyses determined that the national prevalence of Salmonella in raw pork products was highest in comminuted products (28.9%), followed by intact cuts (5.3%) and nonintact cuts (3.9%). Less than 1% of samples analyzed were positive for the top seven STEC. Our findings indicate there is a need for additional pathogen reduction strategies for raw pork products.

FDA Warning Letter - Another Importer Without a FSVP Program for Their Imported Food Items

FDA issued a Warning Letter to Mission, LLC of, Renton, WAS for not have a FSVP (Foreign Supplier Verification Program) in place for the food items that the company was importing.  Specifically, they did not have a FSVP for imported black tea.  As part of this analysis, the company would conduct a hazard analysis on this item and determine if any of the hazards are significant, requiring control by their supplier.

WARNING LETTER
Mission LLC
MARCS-CMS 593118 — February 06, 2020

FDA Closes Investigation into 2019 Fruit Mix Salmonella Outbreak

FDA closed their investigation into the 2019 Salmonella outbreak that was linked to fruit mix from a NJ facility.  The outbreak was first identified in PA health facilities where 31 became ill.  In the end, there were 165 cases with 73 hospitalizations.  While the investigation identified Tailor Cut Produce of North Brunswick, New Jersey as the source, and identified issues at that facility including:

"the inspectors observed these general deficiencies: the firm’s hazard analysis did not identify a known or reasonably foreseeable hazard that required a preventive control; the firm did not identify a preventive control for a hazard when one was needed; and the firm did not maintain the plant in a clean and sanitary condition and keep the plant in repair",

they were not able to identify the origin of the Salmonella.


https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-salmonella-javiana-fruit-mix-december-2019
Outbreak Investigation of Salmonella Javiana: Fruit Mix (December 2019)
FDA’s investigation is complete. CDC announces outbreak is over.
Case Counts
Total Illnesses: 165
 Hospitalizations: 73
 Deaths: 0
 Last illness onset: January 11, 2020
 States with Cases: CA, CO, CT, DE (49), FL, GA, IL, MA, MN, NJ (50), NY (7), PA (49), VA, WA
February 18, 2020

The Importance of Naming the Coronavirus - Covid-19

An interesting article in Vox about the naming of the novel coronavirus. It was given the name Covid-19, derived from COronaVIrus Disease 2019. Not very exciting, although giving it a technical name prevents it from being labeled with a name that can unintentionally create fear...such as tying it a location, tying it to an animal or a food. One just needs to look at swine flu that  resulted in the unneeded culling of some pigs.   Or worse, having the media label it, such as was done with Mad Cow (although that was a prion and not a virus).

VOX.com
https://www.vox.com/2020/2/14/21135208/coronavirus-wuhan-china-covid-19-name-sars-cov-2
The life-and-death consequences of naming the coronavirus

A bad name for an illness can be dangerous. That’s why it took so long to settle on Covid-19.
By Umair Irfan Feb 14, 2020, 10:40am EST

Coronavirus Update - February 14, 2020

In the Coronavirus outbreak, strain designated COVID-19, the case numbers continue to grow, but a testing change by officials in China has had a impact on those numbers, causing the total number to surge higher.  CNBC reports that there are now some 64,000 reported cases wit 1,380 deaths.  There have been 15 cases confirmed in the US, but patients are under quarantine.  The risk in the US is still considered low.

From a Market Watch article - "Health authorities in Hubei Province are now counting cases that have been diagnosed solely by a computed tomography (CT) scan, not a combination of a CT scan and an RNA test. The most recent update from China’s National Health Commission states there were 15,152 new cases, a sevenfold increase over the 2,015 new cases that had been reported the day before. "

The CT method is a quicker analysis compared to the RNA tests that takes days.  The CT scans reveal lung infection, so it is not as specific.  And with a shortage of RNA test kits, many cases were being missed.

From a business perspective, one of the big casualties is the cruise ship operations.  With passenger ships having to quarantine passengers when there is a suspect case, it is easy to see why many may not want to get aboard.

WHO RISK ASSESSMENT
China Very High Regional Level High Global Level High
Market Watch

Report on Food Recalls Fails

In a recent report put out by a public interest group, they claim that grocers do a poor job in communicating recall information.  In "Food Recall Failure Will your supermarket warn you about hazardous food?, the group gave the grocers a failing grade.  Their primary reason, so it seems, the grocers did not send the group the information they requested.  Then the firm conducted their one investigation based on their evaluation of a company's procedures.

Whatever.  This is more of a headline grab than a real evaluation.  Actual evidence will show that grocery stores do a pretty good job at removing items from the shelves, and contacting consumers as best they can.  Can they do better, sure, but it is not the catastrophic failure the article makes it to be.

This is the same group that released "New report: Meat recalls remain high; produce and processed food recalls drop".  One of their top findings - "The most hazardous meat and poultry recalls (Class I) have nearly doubled, up 85 percent percent since 2013. This is a slight increase from 2018. Total meat and poultry recalls are up 65 percent since 2013."  There was no evaluation into what the recalls were, but more of a insinuation that it is all extremely dangerous, when in fact, many of the recalls are either related to allergens or physical material contamination,  or are proactive due to a potential issue, not an actual issue.

FDA Releases Supplemental Draft Guidance on Food Defense Regulation

FDA released a supplemental 'draft' guidance to support the IA Rule (Intentional Adulteration or Food Defense).  It is supplemental in that it adds content on elements not covered in the previous guidance issued last year (Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration March 2019).

This supplemental guidance covers the elements for managing mitigation strategies - specifically corrective action, verification, and reanalysis.  It provides more detail on what FDA would be looking for when evaluating the mitigation strategies the facility has chosen.

As you know, the facility conducts a vulnerability assessment to determine which points in the process are most vulnerable, the actionable process steps.  For the actionable process steps, the facility must determine and implement mitigation strategies to reduce the vulnerability.  These strategies must be monitored, documented, verified, have corrective action, and be reanalyzed.

In general, the guidance allows a more basic and flexible approach than Preventive Controls regarding corrective action and verification activities. For example, if a mitigation strategy is having a tank hatch locked with a monitoring activity stated as checking the lock. The corrective action if a tank is not locked would be to lock it and retrain the employee.  Verification is simply checking records to make sure the lock check was taking place, and the corrective action of retraining the employee took place.  And of course, conducting analysis of the plan every 3 years (unless there is a process change or other special conditions).


https://www.fda.gov/regulatory-information/search-fda-guidance-documents/supplemental-draft-guidance-industry-mitigation-strategies-protect-food-against-intentional
GUIDANCE DOCUMENT
Supplemental Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration 

This Week in Mislabeled Products for Week Ending February 15

Incorrect packaging sleeve - Save A Lot is recalling 131 cases of Coburn Farms 4.5oz Sharp Yellow Cheddar Cheese, Cherry Juice- Infused Dried Cranberries & Roasted Sea Salted Cashews Snackers due to a labeling error leading to undeclared peanut allergens in Snackers packages manufactured by Great Lakes Cheese Co. Inc., headquartered in Hiram, Ohio.  The recall was initiated after it was discovered that a limited number of the Snackers contain peanuts, which, while visible through the packaging and identified on the top label of the individual Snackers tray, were not declared on the ingredient statement. This was due to an incorrect selling unit cardboard sleeve label packaged on a limited number of the Snackers.

FDA finds milk in product, but not on label - Gourmet International and Butlers Chocolates UC are recalling approximately 1900 units of the IRISH WHISKEY DARK CHOCOLATE 3.5OZ TABLET BAR because it may contain undeclared milk.   The recall was initiated after FDA testing found high levels of milk present in the product and milk is not a listed ingredient of the product.

Almond in non-almond product, precautionary statement won't help this - Lotte Int’l America Corp is recalling its 11.85-ounce packages of “Chocopie” manufactured by Lotte Confectionery Co. Ltd. Korea because of findings of small amount of almond in the product and packaging shows the “manufactured in a facility that also processes peanut & almond”.  The company are certain that the problem has been corrected and no illnesses have been reported to date in connection with this problem.  LOTTE Int’l America Corp is working fully in partnership with FDA to fully investigate the matter and comply with all necessary recall procedures. The Company is also taking the necessary steps to address this issue and apologizes for any inconvenience caused by this product issue.

Poor label design or misformulation? - McCormick & Company, Inc. is initiating a voluntary recall of Sunny Select Au Jus Gravy Mix 1 oz pouches due to an unlabeled dairy allergen.

Top label right, bottom label wrong - Missa Bay LLC of Swedesboro, N.J. is recalling 1,154 cases of Ready PacⓇ BistroⓇ Bowl Spinach Dijon Salad due to a labeling error leading to the potential for undeclared egg and wheat allergens on a limited number of the salads. The salads contain eggs and wheat, which, while visible through the packaging and identified on the top label, are not declared on the ingredient statement due to an incorrect bottom (ingredient) label on a limited number of the salads. The recall was initiated after it was discovered that a limited number of the salad bowls containing the eggs and wheat ingredients were distributed in packaging with incorrect bottom (ingredient) labels that did not indicate the presence of the two allergens. The company has taken immediate action to identify the cause of the error and implement a permanent fix to ensure it does not happen in the future.

Incorrect labels on product at packaging - Corinthian Trading, Inc./DBA Corinthian Foods is recalling 5 lb. retail bags of Uncooked Sweet Potato Crusted Alaska Pollack Nuggets 1 oz. with date code CF35319 due to mislabeling. The bag contains Chicken Nuggets instead of Fish Nuggets. The problem was discovered when cases were opened to put our for retail sale, and the label on the retail package did not match the label and description of the master case. Subsequent investigation indicates the problem was caused during the packaging process. The incorrect labels were applied to the product causing the product to be mislabeled.

Improper label design misses milk - Family Traditions Meat Company, an Ackley, Iowa establishment, is recalling approximately 270 pounds of ready-to-eat (RTE) beef stick products due to misbranding and an undeclared allergen - the product contains milk, a known allergen, which is not declared on the product label. The problem was discovered by a compliance officer with the Iowa Department of Agriculture during in-commerce surveillance activities at a retail store.

FDA Releases Interim Results of Pathogen Testing on Fresh Herbs and Processed Avocados

FDA released preliminary results of testing fresh herbs and processed avocados.  Although the levels of contamination are low, one would need to consider these as hazards as a risk when conducting the hazard analysis for these items.

Fresh Herbs - cilantro, parsley and basil

Fresh cilantro, parsley and basil are typically eaten without having undergone a ‘kill step,’ such as cooking, to reduce or eliminate bacteria. These herbs are grown low to the ground and therefore are susceptible to contamination (e.g., from irrigation water splashing off the soil).

From 1996 to 2015, the FDA reported nine outbreaks linked to basil, parsley and cilantro, which resulted in 2,699 illnesses and 84 hospitalizations. Four of the outbreaks were linked to basil, three to cilantro, and two to parsley. Of those same nine outbreaks, seven were attributed to Cyclospora cayetanensis; one was attributed to E. coli O157:H7; and one was attributed to Shigella sonnei. T

Preliminary Findings - The following figures summarize the interim sampling results. As the testing is still underway, no conclusions can be drawn at this time.

Domestic Fresh herbs - 

Salmonella  4  positive of 742 samples (0.5%)

E. coli O157:H7 - No positives from 746 samples 

Shiga toxin-Producing E.coli,  - 4 of 742 but these strains were determined to be non-pathogenic.

Cyclospora - 4 positive from 442 samples (0.9%)

Imported Fresh herbs - 

Salmonella - 9 positive rom 459 samples (2.0%)

E. coli O157:H7 - No positives from 468 samples

Shiga Toxin-producing E. coli - 5 positive from 463 although strains were determined to be non-pathogenic.

Cyclospora - 12 positive from 224 samples (5.4%)

Processed Avocados / Guacamole

"Avocados have a high lipid and moisture content, low carbohydrates, and non-acidic pH level, which can make them a favorable growth medium for harmful bacteria. Processed avocado products, including avocado that is fresh cut, refrigerated and frozen, may be packaged and eaten without having undergone a ‘kill step’ prior to consumption. In addition, processing fresh produce into fresh-cut products increases the risk of bacterial growth by breaking the fruit’s skin and allowing for the spread and potential growth of any pathogens that may be present."

"According to the CDC, there were 12 outbreaks of foodborne illness related to avocado, avocado products or guacamole products from 2005 to 2015. Of those 12 outbreaks, nine involved Salmonella and three involved E. coli, resulting in 525 illnesses and 23 hospitalizations in all. Though no listeriosis outbreaks were reported in connection with avocados from 2005 to 2015, a recent sampling assignment by the FDA detected Listeria monocytogenes in samples collected from the fruit’s pulp and skin."

Preliminary Findings - The following figures summarize the interim sampling results. As the testing is still underway, no conclusions can be drawn at this time.

Domestic Processed Avocado / Guacamole 

Salmonella in 2 positive of 775 samples  (0.25%) 

Listeria monocytogenes - 13 positive of 764 samples (1.7%)

Imported Processed Avocado / Guacamole

Salmonella and there were no positives in 110 samples

Listeria - 2  positives in 108 samples (1.8%)

https://www.fda.gov/food/sampling-protect-food-supply/microbiological-surveillance-sampling-fy18-19-fresh-herbs-cilantro-basil-parsley-and-processed
Microbiological Surveillance Sampling: FY18-19 Fresh Herbs (Cilantro, Basil & Parsley) and Processed Avocado and Guacamole Assignments

Frozen Smoothie Products Recalled Due to Potential Listeria

Blendtopia Products, LLC is voluntarily recalling 29,078 cases of 7 ounce frozen Blendtopia brand Superfood Smoothie Kits because of potential contamination with Listeria monocytogenes. The company discovered the issue through its quality control processes. The issue is believed to be isolated to a supplied ingredient.

So what is a smoothie kit? From the website -
What is in one smoothie kit/pouch?
"Each smoothie kit contains organic frozen fruit and veggies as well as 1.5oz of frozen superfood chips. The superfood chips are comprised of our proprietary organic superfood blend + organic banana puree. All you have to do is empty the contents of the smoothie pouch into your blender, add 12oz of blending liquid and give your blender a whirl! One smoothie pouch/kit will make (1) 18oz or (2) 9oz smoothies."
Shipping
"We ship our smoothies in insulated packaging on dry ice so they stay frozen throughout the entire trip. Make sure to pop them in the freezer as soon as they arrive."

Blending Instructions:

"Remove superfood packet from pouch! Blend pouch + superfoods with 12oz liquid of choice. Plant-based milks such as almond milk or coconut milk are preferred."

An interesting concept.  As a product with no reduction step performed by the consumer, the ingredients must be free of any biological hazards and those ingredients must be assembled / handled in a way that does not contribute contamination to the finished product.  And if Listeria were present, such as in this case, the organism would not likely grow on the items in the packet, especially if frozen.  The risk would be proliferation occurring once the smoothie was made.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/blendtopia-products-llc-voluntarily-recalls-frozen-smoothie-products-due-possible-health-risk
Blendtopia Products, LLC Voluntarily Recalls Frozen Smoothie Products Due to Possible Health Risk
Summary
Company Announcement Date: February 10, 2020
FDA Publish Date:February 10, 2020
Product Type:Food & Beverages Milk/Milk Product
Reason for Announcement: Potential to be contaminated with Listeria monocytogenes
Company Name:Blendtopia Products, LLC
Brand Name: Blendtopia
Product Description: Frozen smoothie products

RI Establishment Recalls Nut Butter After Testing Detects Listeria

Nuts ‘N More of East Providence, RI. is recalling 4143 jars of plain Peanut Spread because it has the potential to be contaminated with Listeria species and to protect the public from a potential health hazard. The recall was a result of potential Listeria species in a finished product found through routine testing conducted by an outside laboratory. The company has ceased the production and distribution of this product as State of Rhode Island and the company continue their investigation.

There was a similar issue last year involving Listeria in nut butter where a Wisconsin company detected Listeria in nut butter.   That recall expanded as it was found the company did not have control.  It will be seen if this recall is expanded beyond the one lot recalled.

How the Listeria got into the product is hard to know without knowing the process. This product is a concoction of ingredients including peanuts, pea powder, peanut oil, palm oil, flax, vanilla, maple flavor, sea salt and sunflower lecithin. It may lack a thermal process, thus having ingredients free of pathogens and having a clean process is critical.  While growth would not be expected in the product thus reducing the risk, we can never be certain how much of the organism may be present or how someone will use the product.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nuts-n-more-llc-recalls-plain-peanut-spread-because-possible-health-risk
Nuts ‘N More LLC. Recalls: Plain Peanut Spread Because Of Possible Health Risk
Summary
Company Announcement Date: February 07, 2020
FDA Publish Date: February 07, 2020
Product Type: Food & Beverages
Reason for Announcement: Potential contamination with Listeria sp,
Company Name: Nuts ‘N More LLC
Brand Name: Nuts ‘N More LLC
Product Description: Plain Peanut Spread

This Week in Mislabeled Products for Week Ending February 8, 2020

Two print-and-apply labels developed incorrectly in that they missed allergens.

New Seasons Market has issued a recall for a total of 30 Grab N' Go Vegetarian Lasagna w/ Gluten-Free Pasta units (UPC 52390), with packed on dates 2/1-2/3, and sell by dates 2/6-2/9.  This product is being voluntarily recalled due to the presence of an undeclared allergen (soy).

Whole Foods Market is voluntarily recalling select bundt cakes and chocolate dipped cookies from stores in Kentucky, Maryland, New Jersey, Pennsylvania, Ohio, Virginia and Washington D.C. because they contain undeclared milk.  I guess they just missed the milk as an ingredient when designing the labels.  (But notice the precautionary label - made in a facility that processes 'everything'...so like it's a cake facility....chocolate cakes...fish cakes, crab cakes,.....)

Coronavirus Update - WHO Situation Report - February 7, 2020

The number of cases of Coronavirus continues to rise.

In China, the doctor who first called attention to the virus has died, reportedly from the virus.  His death has sparked a backlash against China's censorship of him and others who were punished after providing early warning.

Update from World Health Organization
https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200207-sitrep-18-ncov.pdf?sfvrsn=fa644293_2
Novel Coronavirus(2019-nCoV) Situation Report – 18  - February 7, 2020

SITUATION IN NUMBERS total and new cases in last 24 hours
 Globally
              31 481 confirmed (3205 new) 
China
             31 211 confirmed (3151 new) 
              4821 severe (962 new)   
               637 deaths (73 new)
Outside of China     
                270 confirmed (54 new)       
                  24 countries         
                    1 death  .
      United States - 12 confirmed
      Canada - 7 confirmed

EU - Ongoing Salmonella Outbreak Associated with Eggs Highlights Tracking Issues

In Europe, an ongoing Salmonella outbreak associated with eggs shows the difficulty the EU is having in knowing the extent of the issue as well as understanding the egg supply element.  Further, there seems to be little information on the consumer component - what is being communicated to consumers on use of eggs in regard to handling..  Reading through the lengthy report, I am struck by the variation between countries in terms of reporting.  It seems that the issue is only in the UK, but I suspect that the UK is better at confirming, tracking and reporting.

"In most countries, the number of cases found to be genetically linked to this outbreak (confirmed and historical-confirmed cases) is not only influenced by the incidence of the infection, but also by national laboratory practice and capacity. If not available at national level, ECDC has supported countries who have identified probable cases by MLVA with sequencing services for case confirmation. However, for about half of the Member States who are not routinely reporting MLVA or sequencing data to ECDC, the epidemiological situation of this outbreak remains unknown. The true extent of this outbreak is likely under-estimated. Information on the travel history of some outbreak cases point at transmission occurring in countries not yet performing molecular typing and therefore without the capacities to detect outbreak cases."

https://www.ecdc.europa.eu/en/publications-data/multi-country-outbreak-salmonella-enteritidis-infections-linked-eggs-fourth
Multi-country outbreak of Salmonella Enteritidis infections linked to eggs, fourth update 
Risk assessment  
6 Feb 2020
Executive summary

More Bad Press for Chipotle as Workers Throw Jabs Regarding Food Safety Practices

A new report was made public on allegations from 47 workers on food safety practices at Chipotle in NY City.  In the Business Insider article, "workers said that bonuses paid to restaurant managers are based on performance goals "that include minimizing labor costs," creating a "highly pressurized environment." That pressure can lead to "cutting corners on food safety," workers said. Bloomberg previously reported on the workers' allegations on February 5."

It goes on to report that "Workers also said that managers at locations across New York City are often tipped off about when their restaurant will be audited for cleanliness, and that managers "have relaxed rule following outside of inspection periods" but increase food safety protocols "when an audit is imminent." "Workers also raised concerns about lack of training, understaffing, and aging equipment."

The restaurant chain stated that all matters will be investigated.

Delish.com
https://www.delish.com/food-news/a30798397/chipotle-employees-food-safety-cocern/
Chipotle Employees Say That Workers 'Cut Corners' When It Comes To Food Safety
Chipotle is following up on every allegation.
By Alexis Morillo
Feb 6, 2020

PA Dairy Closed After Owner Charged with Securities Fraud

A PA dairy has closed after it's majority owner was charged with fraud in that he lured investors, mostly local Mennonite and Amish, to invest in a failing organic dairy, about $60 million.  "Court documents said Riehl, 68, lured investors to a fund that made most of its loans to Trickling Springs and paid off older investors with money from new investors. He and a co-conspirator also sold promissory notes in an effort to prop up the struggling creamery, lying to investors that it was profitable when in reality it was losing money, according to court documents."

AP Newswire
https://apnews.com/b0a809bf713992bb5ff7e5889e9a2f07
Prosecutors: Owner of shuttered organic dairy ran $60M fraud
By MICHAEL RUBINKAM
January 31, 2020

Patrons Ill After Doing Shots of Cleaning Chemical Stored in Liquor Bottle

Never put food in non-food containers and never put chemicals in food containers.  A simple rule.  Unfortunately, people do it all the time and the results can be disastrous.  Such as a recent case where a bar worker put cleaning solution into a used liquor bottle.  Somehow that liquor bottle with cleaner inside made it's way back to the bar and was then accidentally served as shots to two patrons (as well as the bartender).  Not a way to clean out the pipes.

KIRO 7
https://www.kiro7.com/news/trending/customers-accidentally-served-shots-toxic-cleaning-solution-movie-theater-bar/B7DEYUY5GBARHP44UXR4ALTMKU/
Customers accidentally served shots of toxic cleaning solution at movie theater bar
By: Cox Media Group National Content Desk
Updated: January 31, 2020 - 12:24 PM

Deer Hunters Contract Toxoplasmosis From Undercooked Venison

A recent study published by CDC involves a group of hunters who became infected after all consumed undercooked deer meat.  A group of 10 hunters traveled from Canada to Illinois for a deer hunt.  After returning, about 8 days later, six of the 10 hunters had symptoms of fever, severe headache, myalgia, and articular pain.  It was diagnosed as an acute toxoplasmosis

"Human T. gondii infection is caused by ingestion of tissue cysts in undercooked meat; ingestion of soil, water, or food contaminated with oocysts; or, less frequently, directly from feline feces"

"Little is known of the natural epidemiology of T. gondii infection in white-tailed deer. Given that deer are strict herbivores, it is believed that they become infected postnatally by ingesting oocysts from the environment (7). When ingested, the parasites form tissue cysts in the skeletal muscle and other tissues. When the infected deer die, tissues are scavenged by feline carnivore species, including bobcats and cougars (7). The life cycle then continues, and these cats shed more oocysts into the environment. Estimated Toxoplasma spp. prevalence among white-tailed deer varies across the United States from 15% to 74% (Ohio, Pennsylvania, and Minnesota) (7,9,10,12)."

"Recommendations include not eating raw or undercooked game meat and cooking to an internal temperature of at least 160°F. They also recommend washing hands with soap and water after handling raw meat and cleaning all materials that come in contact with raw meat thoroughly after use. In addition, cysts and oocysts of toxoplasmosis might be destroyed by freezing the meat (23,24). Because the prevalence seems to be high in wild animals in which study prevalence was determined, freezing the meat seems to be efficient to destroy cysts and oocysts."

Emerging and Infectious Diseases
https://wwwnc.cdc.gov/eid/article/26/2/19-1218_article
Volume 26, Number 2—February 2020
Acute Toxoplasmosis among Canadian Deer Hunters Associated with Consumption of Undercooked Deer Meat Hunted in the United States
Colette GaulinComments to Author , Danielle Ramsay, Karine Thivierge, Joanne Tataryn, Ariane Courville, Catherine Martin, Patricia Cunningham, Joane Désilets, Diane Morin, and Réjean Dion

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.

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

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

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

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

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.

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.

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