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.

FDA Investigation into E.coli Outbreak Linked to Romaine Lettuce Finds Cattle Feeding Operation as Potential Source

The FDA continues their investigation into the E. coli outbreak, but are looking at a Concentrated Animal Feeding Operation as a potential source.  This CAFO is stated as being able to hold up to 100,000 head of cattle.

E. coli and 100,000 pooping cattle....that may be a good place to be concerned about especially if there is access from that operation to the canal system.  But the release was short on information specifically the distances from the CAFO to the canal system, and then down to the farming area?  Can cattle ever get to the water?  Can rain water runoff make its way into the CAO? 

Had anyone raised a concern about the locale of the CAFO to the canal system?  Has anyone tested the water if there were a concern?  As a main component of produce safety, water quality and the potential for contamination should have been evaluated.  And as part of that, the potential contamination by farm animals should also have been evaluated.  While testing can be unreliable, a risk analysis of a nearby CAFO should have been undertaken.    But at this point, it is hard to glean this information that FDA has released.

In this outbreak, 210 were infected across 36 states with 96 hospitalizations and five deaths.  In a June 28th news release, FDA and CDC reported that the E. coli strain was found in the irrigation canal.

https://www.fda.gov/food/recallsoutbreaksemergencies/outbreaks/ucm604254.htm
FDA Investigating Multistate Outbreak of E. coli O157:H7 Infections Linked to Romaine Lettuce from Yuma Growing Region
August 6, 2018

FDA Delays Compliance Dates for Agricultural Water as Part of FSMA Produce Safety Rule

The FDA announced that it is planning to extend the deadline for compliance to agricultural water standards used in irrigation as part of the FSMA Produce Safety Rule .  Irrigation water can be a source of pathogens, but it is not an easy to control, especially when that water comes from surface waters.  Work done here at Penn State by Luke LaBorde etal (ref below) found that it was hard to make a connection between water standards and pathogen levels.  So testing water to see if it meets standards that may not mean much in terms of the pathogens present.  It is easy to see how environmental factors will constantly change...whether that be the occasional presence of animals, the amount of rainfall, the amount of sunshine, etc.

For more information on irrigation water, visit the Penn State Extension Website -http://extension.psu.edu/food/safety/farm/gaps/safe-uses-of-agricultural-water

Food Safety Modernization Act (FSMA) Updates
FDA Intends to Extend Compliance Dates for Agricultural Water Standards

Earlier this year, the U.S. Food and Drug Administration announced that it is exploring ways to simplify the agricultural water standards established by the Food Safety Modernization Act’s (FSMA) produce safety rule (PSR) after receiving feedback from stakeholders that some of the requirements are too complex to understand and implement.