FDA to California Leafy Green Growers: It is Past Time to Fix this “Reasonably Foreseeable Hazard”
“This reoccurring pathogenic E. coli strain therefore appears to be a reasonably foreseeable hazard in the California Central Coast leafy greens growing region, and specifically of concern in the South Monterey County area of the Salinas Valley growing area. Farms subject to the FSMA Produce Safety Rule are required to take all measures reasonably necessary to identify, and not harvest, produce that is likely to be contaminated with a known or reasonably foreseeable hazard.”
“The updated plan includes a renewed emphasis on actions to prevent contamination stemming from activities on adjacent land,…”
The FDA has made clear the the Leafy Green Industry is NOT doing enough to protect consumers from persistent environment contamination – specifically by E. coli.
From its investigation the FDA found:
The FDA, in collaboration with California state partners, investigated several farms with fields linked through traceback; we identified the outbreak strain in one cattle feces composite sample taken alongside a road approximately 1.3 miles upslope from a produce farm with multiple fields linked to the outbreak through traceback. In addition, several other samples tested positive for other STEC strains, including E. coli O157:H7.
The FDA reccomends:
The FDA recommends that the agricultural community in the California Central Coast growing region work to identify where this reoccurring strain of pathogenic E.coli is persisting and the likely routes of leafy green contamination with STECs.
In addition, when pathogens are identified through microbiological surveys, pre-harvest or post-harvest testing, we recommend growers implement industry-led root cause analyses to determine how the contamination likely occurred and then implement appropriate prevention and verification measures.
FDA Takes Two Important Steps to Advance the Safety of Leafy Greens April 6, 2021
Today, the U.S. Food and Drug Administration is taking two important steps to advance the safety of leafy greens. The first is the release of a report on the investigation into the Fall 2020 outbreak of E. coli O157:H7 illnesses linked to the consumption of leafy greens. The report describes findings from the investigation, as well as trends key to understanding leafy greens outbreaks linked to the California Central Coast growing region (encompassing the Salinas Valley and Santa Maria growing areas) that have occurred every fall since 2017. In addition, the FDA is also releasing an updated version of the Leafy Green Shiga-toxin producing E. coli (STEC) Action Plan, reaffirming the need for collaborative action to improve the safety of leafy greens, and building on the work accomplished in 2020.
Investigation Report
Between August and December 2020, the FDA and multiple state and federal partners were involved in an investigation into an outbreak of E. coli O157:H7 illnesses associated with the consumption of leafy greens. The outbreak caused 40 illnesses across 19 states, resulting in 20 hospitalizations, including four cases of hemolytic uremic syndrome (HUS), a type of kidney failure.
During the traceback investigation the outbreak was linked via whole genome sequencing (WGS) to outbreaks associated with the consumption of leafy greens grown in California’s Central Coast growing areas that have occurred every fall since 2017. Using the information learned during traceback, along with data collected in response to previous outbreaks, the FDA was able to narrow the scope of the investigation to fields in the Salinas Valley growing area of California. The FDA, in collaboration with California state partners, investigated several farms with fields linked through traceback; we identified the outbreak strain in one cattle feces composite sample taken alongside a road approximately 1.3 miles upslope from a produce farm with multiple fields linked to the outbreak through traceback. In addition, several other samples tested positive for other STEC strains, including E. coli O157:H7. While no direct source or route of contamination was identified, the investigation provided insights into potential sources of contamination, including livestock activities on adjacent land.
Reoccurring outbreak strain, growing region, and concerns with the potential impacts of adjacent lands
The FDA analyzed outbreaks that had occurred each fall since 2017 in light of the findings of this investigation and found three key trends in the contamination of leafy greens by E. coli O157:H7 in recent years: a reoccurring strain, reoccurring region and reoccurring concerns with the potential impacts of adjacent lands. This reoccurring pathogenic E. coli strain therefore appears to be a reasonably foreseeable hazard in the California Central Coast leafy greens growing region, and specifically of concern in the South Monterey County area of the Salinas Valley growing area. Farms subject to the FSMA Produce Safety Rule are required to take all measures reasonably necessary to identify, and not harvest, produce that is likely to be contaminated with a known or reasonably foreseeable hazard.
Recommendations
The FDA recommends that the agricultural community in the California Central Coast growing region work to identify where this reoccurring strain of pathogenic E.coli is persisting and the likely routes of leafy green contamination with STECs. In the report, the FDA encourages producers in the Central Coast of California growing region to participate in the California Longitudinal Study, and in the locally-led, locally-convened California Agricultural Neighbors (CAN) workgroup. In addition, when pathogens are identified through microbiological surveys, pre-harvest or post-harvest testing, we recommend growers implement industry-led root cause analyses to determine how the contamination likely occurred and then implement appropriate prevention and verification measures.
Leafy Greens STEC Action Plan
The FDA recognizes that more work is needed from all leafy greens stakeholders to advance the vision outlined in the Leafy Green STEC Action Plan. Originally released in March 2020, the action plan was designed to foster a more urgent and collaborative approach to preventing leafy greens outbreaks caused by STEC. Progress made to date includes the launch of the California Longitudinal Study, the development of an efficacy protocol to aid in the development and registration of antimicrobial treatments for pre-harvest agricultural water, and several focused inspections, follow-up investigations, sampling assignments, and critical steps taken to advance traceability of leafy greens.
Building on this work, the FDA released an updated version of the Leafy Green STEC Action Plan today which reaffirms our commitment to advancing leafy greens safety. The updated plan includes a renewed emphasis on actions to prevent contamination stemming from activities on adjacent land, announces new actions that build on the accomplishments and learnings from the 2020 plan, and renews our commitment to completing certain actions that were difficult to accomplish in 2020 due to challenges presented by the COVID-19 pandemic.
Shared Responsibility
We know that we cannot fix the issue of leafy green contamination on our own. Recognizing the interconnection between people, animals, plants, and their shared environment, we strongly encourage collaboration to address the issues contributing to produce contamination. Industry leadership, along with collaboration among growers, processors, retailers, state partners and the broader agricultural community, is critical to establishing needed prevention measures and preventing foodborne illness.
Republished with permission from Bill Marler and Marler Clark. Copyright (c) Marler Clark LLP, PS. All rights reserved.
Source: https://www.marlerblog.com/legal-cases/fda-to-california-leafy-green-growers-it-is-past-time-to-fix-this-reasonably-foreseeable-hazard/
Anyone can join.
Anyone can contribute.
Anyone can become informed about their world.
"United We Stand" Click Here To Create Your Personal Citizen Journalist Account Today, Be Sure To Invite Your Friends.
Before It’s News® is a community of individuals who report on what’s going on around them, from all around the world. Anyone can join. Anyone can contribute. Anyone can become informed about their world. "United We Stand" Click Here To Create Your Personal Citizen Journalist Account Today, Be Sure To Invite Your Friends.
LION'S MANE PRODUCT
Try Our Lion’s Mane WHOLE MIND Nootropic Blend 60 Capsules
Mushrooms are having a moment. One fabulous fungus in particular, lion’s mane, may help improve memory, depression and anxiety symptoms. They are also an excellent source of nutrients that show promise as a therapy for dementia, and other neurodegenerative diseases. If you’re living with anxiety or depression, you may be curious about all the therapy options out there — including the natural ones.Our Lion’s Mane WHOLE MIND Nootropic Blend has been formulated to utilize the potency of Lion’s mane but also include the benefits of four other Highly Beneficial Mushrooms. Synergistically, they work together to Build your health through improving cognitive function and immunity regardless of your age. Our Nootropic not only improves your Cognitive Function and Activates your Immune System, but it benefits growth of Essential Gut Flora, further enhancing your Vitality.
Our Formula includes: Lion’s Mane Mushrooms which Increase Brain Power through nerve growth, lessen anxiety, reduce depression, and improve concentration. Its an excellent adaptogen, promotes sleep and improves immunity. Shiitake Mushrooms which Fight cancer cells and infectious disease, boost the immune system, promotes brain function, and serves as a source of B vitamins. Maitake Mushrooms which regulate blood sugar levels of diabetics, reduce hypertension and boosts the immune system. Reishi Mushrooms which Fight inflammation, liver disease, fatigue, tumor growth and cancer. They Improve skin disorders and soothes digestive problems, stomach ulcers and leaky gut syndrome. Chaga Mushrooms which have anti-aging effects, boost immune function, improve stamina and athletic performance, even act as a natural aphrodisiac, fighting diabetes and improving liver function. Try Our Lion’s Mane WHOLE MIND Nootropic Blend 60 Capsules Today. Be 100% Satisfied or Receive a Full Money Back Guarantee. Order Yours Today by Following This Link.
