FDA Guidance to Allow Minor Label Modifications During Pandemic

The FDA issued a guidance document to provide additional temporary flexibility in food labeling requirements to manufacturers and vending machine operators.  Manufacturers can make minor formulation changes in certain circumstances without making conforming label changes, such as making a change to product ingredients, without updating the ingredient list on the packaged food when such a minor change is made.  The goal is to help move into the retail sector that was geared to go to the foodservice or other sector.
The change or modification cannot have an impact on the following:

• Safety: the change cannot affect safety, so allergens still must be correct  - "the ingredient being substituted for the labeled ingredient does not cause any adverse health effect (including food allergens, gluten, sulfites, or other foods known to cause sensitivities in some people, for example, glutamates);" 
• Quantity: The same amount must be there - "generally present at 2 percent or less by weight of the finished food;"
• Prominence: The product must still be the same - one can't label pepperoni pizza as sausage pizza - "the ingredient being omitted or substituted for the labeled ingredient is not a major ingredient in the product;"
• Characterizing Ingredient: one can't leave the pepperoni off the pepperoni pizza - the ingredient being omitted or substituted for the labeled ingredient is not a characterizing ingredient; for example, omitting raisins, a characterizing ingredient in raisin bread;"
• Claims: an omission or substitution of the ingredient does not affect any voluntary nutrient content or health claims on the label;  
• Nutrition/Function: an omission or substitution of the labeled ingredient does not have a significant impact on the finished product, including nutritional differences or functionality. 

https://www.fda.gov/food/cfsan-constituent-updates/fda-announces-temporary-flexibility-policy-regarding-certain-labeling-requirements-foods-humans
FDA Announces Temporary Flexibility Policy Regarding Certain Labeling Requirements for Foods for Humans During COVID-19 Pandemic
Constituent Update
May 22, 2020

CDC Report - Hepatitis A Cases Among Food Handlers as All Those Infected with Hepatitis A

In a CDC report, investigators looked at the uptick of Hepatitis A in many states across the country.  Those regarded as high risk is where "infections are spreading primarily through close contact among persons who use drugs and persons experiencing homelessness, as well as among men who have sex with men (MSM)"  Of interest in the report was the percentage of food handlers, and overall, the percentage of cases associated with food handlers was low (3.8%).  Looking at food handlers, a high percentage of them were people in the high risk - people use drugs, have unstable housing or are homeless, are active in MSM, or had been incarcerated.

From the report, "Among 22,825 hepatitis A outbreak cases reported from these 26 states during July 1, 2016–September 13, 2019, 871 (3.8%) were among food handlers; 587 (67.4%) hepatitis A–infected food handlers reported one or more risk factors (i.e., drug use, unstable housing or homelessness, MSM, or incarceration) during the 15–50 days before symptom onset. "

https://www.cdc.gov/mmwr/volumes/69/wr/mm6920a4.htm
Notes from the Field: Assessing the Role of Food Handlers in Hepatitis A Virus Transmission — Multiple States, 2016–2019
Weekly / May 22, 2020 / 69(20);636–637
Megan G. Hofmeister, MD1; Monique A. Foster, MD1; Martha P. Montgomery, MD1; Neil Gupta, MD1 (View author affiliations)

COVID Times - News Shorts for Week Ending May 23, 2020

CDC Changes Wording on COVID-19 Guidelines Regarding Surfaces - "[CDC] appears to have recently changed its guidelines from early March that initially said it “may be possible” to spread the virus from contaminated surfaces. The CDC now includes "surfaces or objects" under a section that details ways in which the coronavirus does not readily transmit"

Individuals Who Recovered from SARS-CoV-2 Virus Likely to Have Immunity - In a study published in Cell, researchers found that individuals who had been exposed to the virus had a significant immune response, which bodes well for developing a vaccine to the virus.

Nearly Two Hundred FSIS Inspectors Have Tested Positive for COVID-19

Temporary reduction in daily global CO2 emissions during the COVID-19 forced confinement
"The estimated decrease in daily fossil CO2 emissions from the severe and forced confinement of world populations of –17% (–11 to –25%) at its peak are extreme and probably unseen before. Still, these only correspond to the level of emissions in 2006."

FDA Issues Guidance for Using Refer Trailers That Once Held Human Remains

FDA issued a guidance document - Returning Refrigerated Transport Vehicles and Refrigerated Storage Units to Food Uses After Using Them to Preserve Human Remains During the COVID-19 Pandemic - that allows those refrigerated trailers that once held the remains of those who passed from COVID-19 to be used for food transport, provided proper sanitation.

According to the guidance, "Refrigerated food transport vehicles and refrigerated food storage units used for the temporary preservation of human remains during the COVID-19 pandemic subsequently can be safely used for food transport and food storage under certain circumstances.  It is important that food is protected during transport and storage to ensure food is safe for humans and animals and that conditions do not exist that may adulterate the food.  Before returning to service to transport or store human or animal food, refrigerated food transport vehicles and refrigerated food storage units used to hold human remains during the COVID-19 pandemic should be thoroughly cleaned and disinfected."

I just have a problem with this.  You?

USDA Issues Report on 2017-2018 Listeria Outbreak Associated with Country-Cured Ham

USDA-FSIS issued an After Action Review Report on a 2018 Listeria Outbreak associated with country-cured hams.  The case involved product sold by Johnston County Hams of Smithfield, N.C. and in this outbreak, 4 people become infected with one death.  The company recalled close to 90,000 pounds of product.

In the report, the issues involving the product are discussed.  The product supposedly received a cook-in-bag process to eliminate listeria.

• One issue was the product was exposed to the environment  - "The implicated product was considered [by the facility] to have not been exposed to the processing environment after undergoing an initial cook-in-bag lethality step to inactivate vegetative pathogens, including L. monocytogenes. However, the investigation revealed that the product was, in fact, exposed to the processing environment after cooking, which may have allowed the product to become contaminated with L. monocytogenes.:
• "After an initial cooking step in a sealed bag, the ham was removed from the bag, drained of its juices, and placed into a second bag; during this process, the ham may have been cross-contaminated from the processing environment."
• "After being placed in the second bag, the ham and bag were placed into metal molds, the top of which was pressed down to form the ham, then re-cooked. In some instances, this process led to tears in the bag, which allowed the cooked ham to be exposed to the processing environment again."
• The other issue is that the heat treatment used for the product may not have been sufficient considering the product had a low Aw - "Before being cooked multiple times, the ham was salt-cured and dried, thus lowering its water activity. Additionally, the draining of juices may have resulted in drier conditions during cooking. The establishment used FSIS cooking guidance (“Appendix A”) as scientific support that the cooking process achieved lethality of pathogens, including L. monocytogenes. However, Appendix A guidance was not intended for lower water activity products cooked under dry conditions or for products cooked multiple times. L. monocytogenes may survive cooking under these conditions. Hence, the process may not have been lethal to L. monocytogenes."

https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/foodborne-outbreak-investigation/outbreak-lm-ham-2018
Listeria monocytogenes Illness Outbreak Associated with Ready-to-Eat, Country-Cured Ham, 2017–2018
After-Action Review Report 2018-16
May 13, 2020

This Week in Mislabeled Products for Week Ending May 16, 2020

Variety Pack Package Misses Allergen - Evans Food Group Ltd., an Arlington, Texas establishment, is recalling approximately 3,796 pounds of ready-to-eat (RTE) pork skin products due to the product containing soy which is not declared on the product label.  The issue, discovered during a record review, found that one product contains soy – the red hot fried pork skins – is packaged in a variety pack that does not declare soy on the outside package display panel; however, soy is declared on the individual 1-oz. product label and is listed in the individual product’s list of ingredients.

Chicken Wing Packaging Misses Allergens - Zilk’s Plus Resources, LLC of Austin, TX announces a voluntary recall for select 12 oz bottles of Pluckers World Famous Wing Sauces because they may contain undeclared allergens. The recall was initiated after it was discovered that these products were distributed in packaging that did not adequately reveal the presence of soy-, wheat- or milk- containing ingredients in the affected products.

Bread Put in the Wrong Bag - The Essential Baking Company of Seattle, Washington is recalling 84 loaves of 32 oz. Sliced Columbia Bread, expiration date May 6.20, due to undeclared egg. The actual product in the bags may be 16 oz. Challah Bread which was mis-labeled as Sliced Columbia Bread and the label does not declare egg.

Ice Cream with Added Spinach Recalled After Listeria Positive Test

Ramar Foods of Pittsburg, CA, is recalling its 14 ounce packages of Peekaboo branded Mint Chocolate Chip with Hidden Spinach Ice Cream product because of the potential contamination of Listeria monocytogenes, The potential for contamination was discovered after internal routine testing by Ramar Foods revealed the presence of Listeria monocytogenes in some packages of the ice cream.

First, it seems that "hiding" vegetables in ice cream is just wrong.

In the hazard analysis, one would need to recognize that cooked or blanched vegetables would have a Listeria monocytogenes risk. The report does not indicate whether the spinach was cooked/blanched at the establishment or by the supplier. As a post-process addition, the vegetables would need sufficient controls to prevent contamination by Listeria.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ramar-foods-recalls-mint-chocolate-chip-hidden-spinach-ice-cream-because-possible-health-risk
Ramar Foods Recalls Mint Chocolate Chip With Hidden Spinach Ice Cream Because of Possible Health Risk
Summary
Company Announcement Date: May 14, 2020
FDA Publish Date: May 14, 2020
Product Type: Food & Beverages Ice Cream/Frozen Dairy
Reason for Announcement:  Potential to be contaminated with Listeria monocytogenes
Company Name:  Ramar Foods
Brand Name:  Peekaboo
Product Description:  Mint Chocolate Chip with Hidden Spinach Ice Cream

USDA Issues Alert for Ravioli from PA Establishment for E. coli

USDA FSIS issued "a public health alert because approximately 70 pounds of raw beef ravioli products, produced by P&S Ravioli Company, a Philadelphia, Pa. establishment, may be contaminated with E. coli O157:H7. A recall was not requested because the affected product is no longer available for purchase."  According to the report, "The problem was discovered when P&S Ravioli Company was notified by their third-party laboratory that a sample was positive for E. coli O157:H7, but the products associated with the sample had already been shipped into commerce. The establishment notified FSIS of the sampling results and subsequently controlled all product remaining for sale."

https://www.fsis.usda.gov/wps/portal/fsis/newsroom/news-releases-statements-and-transcripts/news-release-archives-by-year/archive/2020/pha-05122020-01
FSIS Issues Public Health Alert for Raw Beef Ravioli Products Due to Possible E. Coli O157:H7 Contamination
5/12/20

COVID Times - News Shorts for May 14, 2020

FDA Issues Alert on Accuracy of Allergen Test - FDA issued an alert that they have data that suggests potential inaccurate results from using the Abbott ID NOW point-of-care test to diagnose COVID-19. Specifically, the test may return false negative results. FDA has received 15 adverse event reports about the Abbott ID NOW device that suggest some users are receiving inaccurate negative results.  Of course, false negatives are worse than false positives in that someone has the infection but is told they don't.

CDC Report on High Infection Rate Following a Choir Practice - Following a 2.5-hour choir practice attended by 61 persons, including a symptomatic index patient, 32 confirmed and 20 probable secondary COVID-19 cases occurred (attack rate = 53.3% to 86.7%); three patients were hospitalized, and two died. Transmission was likely facilitated by close proximity (within 6 feet) during practice and augmented by the act of singing.

Why Bats Can Carry Bad Viruses and Not Get Sick - Super Immunity - “Instead of killing bat cells as the virus does with human cells, the MERS coronavirus enters a long-term relationship with the host, maintained by the bat’s unique ‘super’ immune system,” 

The Virus Can Also Infect Cats, Minks, and Ferrets - This article discusses the virus's protein pike structure, but states that "Cats, ferrets and minks are also susceptible: In order to infect a cell, features of the spike protein must bind with a receptor on the host cell’s surface, and cats have a receptor binding site that closely matches that of humans."

COVID Virus's Cellular Targets Are In More Than Just Respiratory System - The COVID-19 "virus's  “spike” protein binds to a receptor on human cells known as angiotensin-converting enzyme 2 (ACE2). Another human protein, an enzyme called TMPRSS2, helps to activate the coronavirus spike protein, to allow for cell entry."  Epithelium cells that line the airway have these receptors, and so this is the primary means of infection.  But these cell types are found in other parts of the body including the intestines.  This is the reason we see a wide variety of symptoms, including that "approximately one third of COVID-19 patients experience gastrointestinal symptoms such as diarrhea, and the fact that the virus often can be detected in stool samples ."  

Unfortunately for men, they have a higher concentration of ACE2 in their blood.

How Does COVID-19 Become Deadly - A lot of news articles have detailed the "cytokine storm”. that occurs after an infection starts.  "This storm is an over-activation of white blood cells, which release too-great amounts of cytokines – inflammation-stimulating molecules – into the blood."  "The rapidly increased cytokines attract an excess of immune cells such as lymphocytes and neutrophils, resulting in an infiltration of these cells into lung tissue and thus cause lung injury".

Hot Dog Sales are Up - "American households continue to turn to hot dogs as a convenient and kid-friendly solution with many more at-home meal occasions. The week ending May 3 marked the ninth week of multi-digit year-over-year sales gains for hot dogs vs. a nearly flat performance in 2019." 

Farmers' Markets Are Busy, But They Endure Higher Operating Costs  - Farmers' Markets have done an excellent job at providing a safe shopping experience during the COVID-19 pandemic, but their higher costs of operations have severely cut into profitability.