FDA Issues First Injunction Under Produce Safety Rule Shutting Down an Illinois Food Processor

The FDA issued the first injunction against a firm or grower for violating the Produce Safety Rule enacted under FSMA.  The Illinois processor  of sprouts and soy products has stopped production until it undertakes corrective action and comes in compliance with the regulations.  This comes after FDA had conducted multiple inspections where they documented insanitary conditions showing that sprouts and soy products had been produced in insanitary conditions.

The company had been issued a Warning Letter in July in which identified violations where significant evidence of rodent activity and insanitary conditions and practices throughout the farm mixed-type facility. Based on these findings, FDA determined that the mung bean sprouts, tofu products, and soybean noodle products were adulterated.  They noted employees shoveling product back up off the floor, product getting hung up in equipment, poor water handling systems, an inadequate Listeria control program,  extensive rodent infestation, inadequate handwashing facilities,  inadequate allergen labeling, etc.


FDA News Release
https://www.fda.gov/news-events/press-announcements/fda-issues-first-injunction-under-produce-safety-rule-illinois-based-food-manufacturer-repeated-food
FDA issues first injunction under Produce Safety Rule to Illinois-based food manufacturer for repeated food safety violations

For Immediate Release:
September 15, 2020

The U.S. Food and Drug Administration announced today that Fortune Food Product, Inc., an Illinois-based processor of sprouts and soy products, has agreed to stop production until it, among other things, undertakes remedial action and complies with the Federal Food, Drug, and Cosmetic Act.

USDA Updates Rules for Egg Processing Operations

USDA updated regulatory inspection rules for egg products. Egg products, along with meat and poultry products, fall under the food safety jurisdiction of the USDA. Like meat and poultry product operations, egg processing facilities will move to intermediate inspection rather than continuous inspection and require companies to use HACCP to manage their own food safety systems. Processors of freeze-dried eggs and egg substitutes will also fall under USDA regulatory oversight.

This makes sense to have companies manage their own safety through HACCP systems without the need for continuous government inspection. This also brings these facilities in line with meat and poultry product regulatory rules.

USDA New Release
https://www.fsis.usda.gov/wps/portal/fsis/newsroom/news-releases-statements-transcripts/news-release-archives-by-year/archive/2020/nr-09092020-01
USDA Modernizes Egg Products Inspection

OSHA Fines CO Meat Processor for Coronavirus Protection Failures

The US Occupational Safety and Health Administration (OSHA) issued $15,615 in penalties to JBS's Colorado meat processing facility for failing to protect employees from COVID-19 virus exposure.
"OSHA guidance details proactive measures employers can take to protect workers from the coronavirus, such as social distancing measures and the use of physical barriers, face shields and face coverings when employees are unable to physically distance at least 6 feet from each other. Employers are also required to maintain injury and illness logs."

The company has 15 days to respond.

U.S. Department of Labor OSHA News Release
https://www.osha.gov/news/newsreleases/region8/09112020
September 11, 2020
U.S. Department of Labor Cites JBS Foods Inc. for Failing To Protect Employees from Exposure to the Coronavirus

ICMSF Opines that the COVID-19 Virus Not a Food Safety Risk

 The ICMSF (International Commission on Microbiological Specifications for Food) issued a position paper (ICMSF opinion on SARS-CoV-2 and its relationship to food safety)  indicating that SARS-CoV-2 or the COVID-19 virus, is not transmissible through food.  "The ICMSF believes that it is highly unlikely that the ingestion of the SARS-CoV-2 will result in illness; there is no documented evidence that food is a significant source and/or vehicle for transmission of SARS-CoV-2.  They also state that "It is vital that one differentiates a hazard from a risk, i.e., the mere presence of an infectious agent on food does not necessarily mean that an infection will occur"

This Week in Mislabeled Products for Week Ending September 12, 2020

Mislabeling Peanut Sauce By Applying Wrong Label - Pretty Thai of Austin, Texas, is recalling Pretty Thai Peanut Sauce that may have been mislabeled as Pretty Thai Sweet Chili Sauce. There is a risk that a person with an allergy or severe sensitivity to peanuts.  Subsequent investigation indicates the problem was caused by a temporary breakdown in the manufacturer's production and packaging processes.

Sourcing Error Results in Undeclared Anchovies (Fish) -  Fresco Foods Inc. of Tampa, FL is voluntarily recalling ALL units of ANCIENT GRAIN JACKFRUIT BOWL because it may contain an undeclared allergen, Fish (anchovies). The allergy alert was initiated after it was discovered that the Ancient Grain Jackfruit Bowl containing Fish (anchovies) was distributed in packaging that did not reveal the presence of Fish (anchovies). Subsequent investigation indicates the problem was caused by sourcing the wrong sub-ingredient.

Cheese, Not On Label, Identified at Store Level - Cher-Make Sausage Company, a Wisconsin establishment, is recalling approximately 429-lbs of fully-cooked meat sausage products due to misbranding and an undeclared allergen -the product contains milk (cheese), which is not declared on the packaging label. The problem was discovered after the firm received a complaint from a store employee who observed cheese in the product.

Allergen Reaction to Wheat by Customer Trigger Recall of Product Produced by Co-Packer - Goodie Girl Tribeca LLC announced today it is voluntarily recalling 389 cases of a single date code of 7 oz. Goodie Girl Magical Animal Crackers, with a “best by” date of Jan 11, 21A3, after learning that the product may contain undeclared wheat ingredients.  There has been an individual with a wheat allergy that was treated for a wheat allergen reaction.  There has been an individual with a wheat allergy that was treated for a wheat allergen reaction.  This recall was initiated in cooperation with the FDA and the third-party co-packer that produced the product.

COVID-19 Prevention - The Importance of Controlling Aerosols with Proper Masks and Ventilation

Aerosols are considered one of the primary means for spread of the COVID-19 virus, thus the control of aerosols are critical for reducing risk. Two articles on the topic cover important aspects of control.

First is an article, Face Shields, Masks with Valves Ineffective Against COVID-19 Spread, that looks at a recently published study evaluating face shields and masks with valves. While these face shields are easier for some to use, they are not effective in controlling aerosols. The same goes with the masks that have vents. These are not effective at controlling aerosols from the person wearing them. One could probably figure that these would not be able to control aerosols, but here is research that proves that they are not effective controls for minimizing the risk of spreading virus.

The second was an article in the Wall Street Journal that looks at the need for good airflow in classrooms and other settings where there are a group of people. The article, Key to Preventing Covid-19 Indoors: Ventilation, discusses the importance of air movement with the need for moving air in the room - bringing in fresh air and expelling air from the room without it blowing from one person to another.

The article discusses a few cases where improper ventilation was a problem

"Five people sitting at tables adjacent to an infected but presymptomatic diner inside a Guangzhou, China, restaurant in January later tested positive for Covid-19, despite video that indicates the separate parties didn’t have close contact, according to an April study published on a preprint server. Some patrons who contracted the virus, the authors said, were seated as far as 15 feet away from the infected diner."

FDA Warning Letters Issued to Importers for Non-compliance to FSVP

FDA issued Warning Letters to four importers for not have Foreign Supplier Verification Programs in place for the food items these companies were importing. 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.


Martinez Mexican Produce, LLC, at 1704 N. International Blvd., Hidalgo, TX 78557.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/martinez-mexican-produce-llc-607645-06162020

Fides New York Inc. located at 4725 208th Street, Bayside, NY 11361-3214
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fides-ny-inc-608989-07292020

Gourmet and More, Inc. located at 2976 Alvarado St., Ste D, San Leandro, CA 94577.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gourmet-more-608887-07312020

Grupo RM USA, Inc., located at 7991 NW 82nd Ave. Miami, FL 33166.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/grupo-rm-usa-inc-609291-08062020

FDA Issues Warning Letter to South Carolina RTE Sandwich Company for Failure to Control Listeria

FDA Issued a Warning Letter to Grand Strand Sandwich Shop after investigators found Listeria in the processing environment.  This strain was the same strain that was found in previous inspections.

"Environmental swabs collected during each of the past three FDA inspections revealed L. monocytogenes in your facility as follows:

- 2020: four (4) swabs collected from locations adjacent to food contact surfaces.

- 2018: seventeen (17) swabs primarily collected from food contact surfaces and locations adjacent to food contact surfaces.

- 2017: five (5) swabs within your facility primarily collected from locations adjacent to food contact surfaces.

Whole genome sequencing (WGS) was conducted on the above referenced L. monocytogenes isolates obtained from the FDA environmental samples. The current WGS analysis determined that the isolates derived from the samples collected at your facility during our 2020, 2018, and 2017 inspections represent a single strain of L. monocytogenes0".

FDA indicated that the company's corrective action when finding Listeria was not adequate in that FDA found Listeria in the same locations that the company had found Listeria.

"Your firm implemented corrective actions, which included cleaning and sanitizing, followed by conducting environmental swabbing on that location to determine these were effective. On February 24, 2020, FDA’s environmental swabbing isolated L. monocytogenes from a (b)(4) in your (b)(4), which appears to be the same location of your January 6, 2020 finding."

The company also failed to recognize a hazard for an ingredient they purchased...more specifically L. monocytogens in the purchased RTE ingredients used in making sandwiches.

There were additional issues associated with verification and allergen control.

FDA Warning Letter

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/grand-strand-sandwich-company-inc-607559-08042020
Grand Strand Sandwich Company, Inc.
MARCS-CMS 607559 — August 04, 2020

FDA Update on Peaches Recalled for Salmonella - International and National Distribution

In FDA's update on peaches recalled for Salmonella,  Canada, Singapore, and New Zealand have issued recalls of Prima Wawona peaches. FDA indicates that recalled Wawona peaches were shipped to foreign consignees in Australia, Canada, China, Costa Rica, Ecuador, El Salvador, Guatemala, Honduras, Mexico, Panama, the Philippines, Singapore, Taiwan, and the United Arab Emirates.

Within the US, retailers across the nation have received the Wawona peaches.

Consumers who purchased Wawona peaches or if they cannot identify the brand or remember the date of purchase, should throw the product away. Consumers who may have frozen peaches supplied by Prima Wawona should throw them away.

There is no further information on the source of the Salmonella. Within the US, 78 have been infected with 23 hospitalizations.

https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-salmonella-enteritidis-peaches-august-2020
Outbreak Investigation of Salmonella Enteritidis: Peaches (August 2020)
Do not eat, sell, or serve recalled loose or bagged peaches packed or supplied by Prima Wawona

Case Counts
Total Illnesses: 78
Hospitalizations: 23
Deaths: 0
Last illness onset Date: August 3, 2020
States with Cases: CT, IA, KY, MD, MI, MN, MO, NJ, NY, PA, VA, WI
Product Distribution*: Nationwide