FDA Warning Letter - Michigan Food Company for RTE Sandwiches, Salads and Bakery Products

FDA issued a Warning Letter to a Michigan Food company, Quality Dairy Company of Lansing, MI.  The company produces ready-to-eat (RTE) sandwiches, salads, and bakery items.  There were issues with the Preventive Control plan as well as with GMPs.

Preventive Controls

• "sanitation control procedures did not ensure cleanliness of food-contact surfaces and prevention of cross-contamination,"
• "sanitation controls monitoring records as part of the Sanitation Preventive Controls were not reviewed within 7 working days after the records were created"
• "did not implement your written sanitation control verification procedures for environmental monitoring - did not do environmental monitoring as they had written in their plan"

GMPs

• "observed five apparent dead German cockroaches and "our investigators observed one apparent live German cockroach nymph crawling on the MDARD Inspector’s white inspection coat"observed flying insects in your facility which were most concentrated along the donut lines."
• "an employee used a pressurized hose to rinse/spray cleaned production equipment and floors. We observed overspray from spraying the floors being deposited on exposed cleaned and sanitized production equipment and utensils."
• "a sanitation employee scrubbed the donut cooling conveyor, a food contact surface, with a brush that was stored in a yellow bucket with water. This bucket is the same shape, color, and style with the same markings as the yellow buckets used to mop the floors around the facility."

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/quality-dairy-company-604285-05132020
WARNING LETTER
Quality Dairy Company
MARCS-CMS 604285 — May 13, 2020

COVID-19 Prevention Plan for Food Establishments

A HACCP based approach for conducting a risk assessment for COVID-19.  While done for foodservice establishments, it can be used for any type of operation.

https://extension.psu.edu/covid-19-prevention-plan-for-food-establishments
COVID-19 Prevention Plan for Food Establishments

As restaurants and food operations reopen during the COVID-19 pandemic, owners and managers must put controls in place to limit the risk of infection for both employees and customers.

Establishments are encouraged to follow state and federal guidelines, including those published by OSHA, the Occupational Safety and Health Administration. OSHA developed a COVID-19 planning guidance based on traditional infection prevention and industrial hygiene practices. OSHA is tasked with investigating workplaces where there is the potential for SARS-Cov-2 infection.

As part of the OSHA guidance for food retail establishments, titled "Retail Workers and Employers in Critical and High Customer-Volume Environments", employers have been asked to assess their operation and implement controls to reduce the risk of infection. While there is no requirement for a written assessment, there are many advantages to having a documented assessment.

Click here for the Form - COVID-19 Risk Assessment Form for OSHA Guidelines (2020-05)

One advantage is that it allows the manager or owner to visualize what procedures need to be in place. This is especially beneficial for operations with multiple operating units where it may be easier to miss some element within a given operation. Conducting an assessment will show due diligence regarding liability in the event of an infection outbreak centered at the establishment.

It is important to remember that each operation is different, thus the types of controls used will vary depending on the specifics of a given operation. There are physical controls, or what OSHA calls Engineered Controls, that are physical elements such as plexiglass shields between the customer and the person taking the order. Another category of controls is termed Administrative and these are procedural in nature, for example, limiting the number of people in a food establishment. Finally, there are personal protective equipment, or PPE controls, which includes the use of face coverings and gloves.

It is best to have written procedures that provide more consistent application of the procedure over time and allow for more standardized training of employees. All employees should be trained, and this training should be documented.

OSHA appears to be getting more involved in workplace related COVID-19 cases. The agency has recently announced that operations should determine whether employee COVID-19 illnesses are work-related and thus recordable when employees come down with infection. Having a solid plan for preventing infection and then implementing that plan with documentation will go a long way to making a safer workplace without the need for OSHA enforcement.

Reference

FDA. Best Practices for Retail Food Stores, Restaurants, and Food Pick-Up/Delivery Services During the COVID-19 Pandemic.

OSHA. Retail Workers and Employers in Critical and High Customer-Volume Environments.

This Week In Mislabeled Products for Week Ending May 30. 2020

Chicken in the Box, but Not on the Label - Nestle Prepared Foods Company, a Jonesboro, Ark. establishment, is recalling approximately 29,002 pounds of chicken product labeled as Lean Cuisine Fettuccini Alfredo because the product contains undeclared soy.  The Lean Cuisine Fettuccini Alfredo is not supposed to contain chicken and chicken does not appear in the ingredients statement or on the label.  The problem was discovered when the firm received multiple consumer complaints that the product labeled as Lean Cuisine Fettuccini Alfredo contained chicken that is not referenced on the label or ingredients.

Someone Grabbed the Out-Dated Labels - Johnson Sea Products of Coden, AL, is recalling its 12oz package of frozen “Home Style Crab cakes” because they contain undeclared ingredients of wheat and soy.   The recall was initiated after it was discovered that the wheat and soy containing product was distributed in packaging that did not reveal the presence of wheat or soy. Subsequent investigation indicates the problem occurred when an out-dated sample label was used on the Home Style Crab Cakes that contain wheat and soy.

The Importance of Masks in Reducing the Risk of COVID-19

An article in the journal Science details the importance of masks in reducing transmission of the SARS-CoV-2 virus.  Social distancing may not be sufficient by itself, especially in indoor conditions., so masks help to reduce aerosols, the leading method of spread, especially from asymptomatic or pre-symptomatic individuals.  Even the act of speaking can emit aerosols.  And any properly fitting mask will help reduce the risk.   (Of course, wearing a mask down around your chin, with mouth and nose exposed, does nothing).

Science
https://science.sciencemag.org/content/early/2020/05/27/science.abc6197
Reducing transmission of SARS-CoV-2

Kimberly A. Prather1, Chia C. Wang,2,3 Robert T. Schooley4 1Scripps Institution of Oceanography, University of California San Diego, La Jolla, CA 92037, USA. 2Department of Chemistry, National Sun Yat-sen University, Kaohsiung, Taiwan 804, Republic of China. 3Aerosol Science Research Center, National Sun Yat-Sen University, Kaohsiung, Taiwan 804, Republic of China. 4Department of Medicine, Division of Infectious Diseases and Global Public Health, School of Medicine, University of California San Diego, La Jolla, CA 92093, USA. Email: kprather@ucsd.edu 

Masks and testing are necessary to combat asymptomatic spread in aerosols and droplets

Excerpts:

"Recent studies have shown that in addition to droplets, SARS-CoV-2 may also be transmitted through aerosols. A study in hospitals in Wuhan, China, found SARS-CoV-2 in aerosols further than 6 ft from patients with higher concentrations detected in more crowded areas (8). Estimates using an average sputum viral load for SARS-CoV-2 indicate that 1 min of loud speaking could generate >1000 virion-containing aerosols (9). Assuming viral titers for infected super-emitters (with 100fold higher viral load than average) yields an increase to more than 100,000 virions in emitted droplets per minute of speaking."

"The World Health Organization (WHO) recommendations for social distancing of 6 ft and hand washing to reduce the spread of SARS-CoV-2 are based on studies of respiratory droplets carried out in the 1930s. These studies showed that large, ~100 μm droplets produced in coughs and sneezes quickly underwent gravitational settling (1). However, when these studies were conducted, the technology did not exist for detecting submicron aerosols. As a comparison, calculations predict that in still air, a 100-μm droplet will settle to the ground from 8 ft in 4.6 s whereas a 1-μm aerosol particle will take 12.4 hours (4). Measurements now show that intense coughs and sneezes that propel larger droplets more than 20 ft can also create thousands of aerosols that can travel even further (1). Increasing evidence for SARS-CoV-2 suggests the 6 ft WHO recommendation is likely not enough under many indoor conditions where aerosols can remain airborne for hours, accumulate over time, and follow air flows over distances further than 6 ft (5, 10)."

"Overall, the probability of becoming infected indoors will depend on the total amount of SARS-CoV-2 inhaled. Ultimately, the amount of ventilation, number of people, how long one visits an indoor facility, and activities that affect air flow will all modulate viral transmission pathways and exposure (10). For these reasons, it is important to wear properly fitted masks indoors even when 6 ft apart. Airborne transmission could account, in part, for the high secondary transmission rates to medical staff, as well as major outbreaks in nursing facilities."

"After evidence revealed that airborne transmission by asymptomatic individuals might be a key driver in the global spread of COVID-19, the WHO recommended universal use of face masks. Masks provide a critical barrier, reducing the number of infectious viruses in exhaled breath, especially of asymptomatic people and those with mild symptoms (12) (see the figure). Surgical mask material reduces the likelihood and severity of COVID-19 by substantially reducing airborne viral concentrations (13). Masks also protect uninfected individuals from SARS-CoV-2 aerosols (12, 13). Thus, it is particularly important to wear masks in locations with conditions that can accumulate high concentrations of viruses, such as health care settings, airplanes, restaurants, and other crowded places with reduced ventilation. The aerosol filtering efficiency of different materials, thicknesses, and layers used in properly fitted homemade masks was recently found to be similar to that of the medical masks that were tested (14). Thus, the option of universal masking is no longer held back by shortages."

"From epidemiological data, countries that have been most effective in reducing the spread of COVID-19 have implemented universal masking, including Taiwan, Hong Kong, Singapore, and South Korea."

FDA and USDA Issue Guidance to Help Make PPE Available to Food Establishments During COVID-19 Pandemic

 FDA and USDA has developed the following recommendations shortages in PPE, cloth face coverings, disinfectants, and sanitation supplies during the COVID-19 pandemic.  As a critical infrastructure, food facilities need access to these items.    "If suppliers are unable to provide for your needs, and the PPE and/or cloth face coverings are urgently required, submit a request for assistance to your state emergency management agencies. If the state is unable to address the PPE and/or cloth face covering shortfall, the state should submit a request for support to their FEMA Regional Response Coordination Center."

https://www.fda.gov/food/food-safety-during-emergencies/food-and-agriculture-considerations-prioritization-ppe-cloth-face-coverings-disinfectants-and
Food and Agriculture: Considerations for Prioritization of PPE, Cloth Face Coverings, Disinfectants, and Sanitation Supplies During the COVID-19 Pandemic

Purpose

The purpose of this document is to share recommendations for addressing shortages of personal protective equipment (PPE), cloth face coverings [1], disinfectants, and sanitation supplies in the food and agriculture industry in order to help maintain employee safety, continuity of the food supply, food safety, and employee/consumer confidence.

Frozen Meals Recalled Due to Complaints of Small Rocks in Product

Conagra Brands, Inc., Russellville, Ark. and Marshall, Mo. establishments, are recalling approximately 276,872 pounds of not ready-to-eat chicken and turkey bowl products because the products may contain extraneous material, specifically small rocks,   This release is being issued as an expansion of the April 10, 2020 recall to include additional products (to include Healthy Choice Power Bowls Chicken Feta & Farro Bowls, Healthy Choice Power Bowls Unwrapped Burrito Scramble Power Bowls, and Healthy Choice Power Bowls Turkey Sausage & Egg Scramble Power Bowls produced on various dates. The products were produced at two different establishments.)  The problem was discovered when the firm received additional consumer complaints about rocks being in the products and the firm then notified FSIS of the issue.

"In a statement sent to USA TODAY, Conagra spokesman Dan Hare said a limited amount of the bowls was being "voluntarily recalled due to the potential presence of small rocks that likely remained from harvesting ingredients contained in the product."

https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2020/recall-007-2020-exp-release

Conagra Brands, Inc. Recalls Frozen Not-Ready-To-Eat Chicken and Turkey Bowl Products due to Possible Foreign Matter Contamination
Class I Recall
007-2020-EXP
Health Risk: High
May 22, 2020

Curry Spice Recalled Due After FDA Testing Finds Salmonella

New Hoque and Sons, Inc. of Maspeth, NY is recalling Radhuni Curry Powder, contained in 400g plastic bottles, because it has the potential to be contaminated with Salmonella.  "The recall was as the result of a routine sampling program by the FDA, which revealed that the finished products contained the bacteria. The company has ceased the distribution of the contaminated products and has also physically removed the contaminated products from stores as FDA and New Hoque and Sons, Inc. continue their investigation as to what caused the problem."

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/new-hoque-and-sons-inc-recalls-radhuni-curry-powder-because-possible-health-risk
New Hoque and Sons, Inc. Recalls Radhuni Curry Powder Because of Possible Health Risk
Summary
Company Announcement Date:  May 21, 2020
FDA Publish Date:  May 21, 2020
Product Type: Food & Beverages   Spices, Flavors & Salts
Reason for Announcement:  Salmonella
Company Name:  New Hoque and Sons, Inc.
Brand Name:  Radhuni
Product Description:  Curry Powder

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)