Tag Archives: foodborne illness

Gary Nowacki
FST Soapbox

It’s Time To Embrace Ingredient Agility

By Gary Nowacki
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Gary Nowacki

In a recent Politico report, critics blasted the U.S. Food and Drug Administration (FDA) for chronic failures, including instances of contaminated baby formula, outbreaks of contaminated produce and the agency’s institutional reticence to implement changes.[1] Compounding the situation is the most fragmented global supply chain in history, making it a particularly challenging time for food and beverage companies.

Ingredients are the building blocks of the supply chain, so when circumstances threaten their integrity and availability, the ripple effect can linger for weeks, months or even years. As the FDA’s limitations become more apparent and supply chain challenges persist, brands must take responsibility for foundational change that addresses and mitigates risks related to food-, beverage- and supplement-borne illness.

Food Safety and Supply Chain Issues Challenge CPGs

As the Politico coverage pointed out, high turnover at the top of FDA has contributed to the agency’s challenges: five different commissioners have led the FDA over the last three years. In addition to concerns with federal oversight, brands are still navigating a broken supply chain, which has taken a beating over the last few years. And while the damage has come from war, trade tariffs and shipping congestion, food safety also emerged as a culprit when the FDA announced a recall of some of the country’s most popular infant formula brands. In February, the agency announced it was investigating consumer complaints of bacterial infections in four infants who were hospitalized. This bacterial infection might have contributed to death in two cases.[2]

While the recall emerged as a catalyst for the U.S. formula shortage, it wasn’t the only factor. Import restraints and market concentration (four companies produce 90% of the formula sold [3]) contributed to this perfect storm that rocked an already strained supply chain. National out-of-stock rates peaked at 70% near the end of May, and regulators announced that they did not expect relief until July. [4]

In scenarios such as this, the best defense brands can employ is to build a diverse supplier base and agile ingredient supply chain. Relying on a limited number of ingredient suppliers is a risky strategy even under the best of market conditions. But when disaster strikes, it can cripple a manufacturer and grind production to a halt. For the sake of consumers, creating agility and resilience around ingredients and sourcing is critical.

Equally important to cultivating relationships with alternate suppliers is the ability to have quick access to critical data. A robust digital document management system that offers manufacturers a unified view of products, data and processes across the business and the supply chain can help brands ensure they have a resilient ingredients network able to withstand supply chain or ingredient-sourcing issues. CPGs can benefit from instant access to millions of supplier documents to help fast-track sourcing, formulation and recipe development as well as protect themselves from potential disaster.

Pandemic Uncertainty and New Legislation

As the pandemic ramped up in March 2020, the FDA announced it would pause most foreign food inspections.[5] Additionally, regulators moved to virtual audits to keep their inspectors safe from COVID. Recalls fell. The FDA reported 495 recalls in the fiscal year 2020 and 427 in 2021. By comparison, the agency reported 526 recalls in the fiscal year 2019.[6]

The drop in recalls could be attributed to the ongoing rollout of the Food Safety Modernization Act (FSMA), which strengthened food production safeguards. In addition, a proposed rule change to FSMA, Section 204, would enforce better recordkeeping and quicker recall responses. The introduction of the Formula Shortage Reporting Act of 2022, requiring immediate action from manufacturers when future disruptions to production occur, is another step toward stricter food standards.

If passed, Section 204 would require companies who process, pack or hold items on the food traceability list (FTL) to capture and store ingredient data for two years, and submit it within 24 hours of a recall.[7] Without a formal system of record in place to manage food production, tracing ingredients—where, when and from whom they came—is a difficult and complex challenge to solve. Human error, overseas suppliers, recalls and other constantly changing variables all must be tracked and monitored constantly. This diligence demands automation and collaboration at scale.

Collaboration via holistic networked platforms can facilitate that diligence by enabling global ingredients suppliers, CPG brands, co-manufacturers and packing companies to build safer, stronger and more modern supply chain networks. Today, the stakes of not having a modern supply chain and access to real-time ingredient data have grown exponentially beyond profit and competitive advantage to a whole new level of costing lives.

Nimble Access to Ingredient Data is Crucial

On May 27, U.S. Sen. Edward J. Markey, D-Massachusetts, introduced the “Ensuring Safe and Toxic Free Foods Act.” The bill, co-sponsored by Sens. Richard Blumenthal, D-Connecticut, and Elizabeth Warren, D-Massachusetts, would—among other things—strengthen the Substances Generally Recognized as Safe (GRAS) Rule, which allows companies to avoid pre-market approval for food chemicals.[8]

The bill would direct the FDA to revise the GRAS Rule to include provisions that:

  • Prohibit manufacturers from designating substances as safe without supplying proper notice and supporting information to the Secretary of Health and Human Services
  • Require safety information to be publicly available on the FDA website and subject to a 90-day public review period
  • Prohibit carcinogenic substances from receiving GRAS designation
  • Prohibit substances that show reproductive or developmental toxicity from receiving GRAS designation
  • Prohibit people with conflicts of interest from serving as experts in reviewing and evaluating scientific data regarding GRAS designations

Brands must have easy access to ingredient data to ensure compliance with the GRAS revisions as well as be proactive about food safety. Software that monitors threats and regulatory risks throughout the supply chain in real-time is essential to prevent both food safety issues and supply chain disruptions. These systems transform massive amounts of data into user-friendly, actionable insights for fast and effective risk management.

Food safety remains one of the gravest public health threats to consumers worldwide. The U.S. Centers for Disease Control and Prevention (CDC) insists that foodborne diseases cause 76 million illnesses in the U.S. annually, leading to 325,000 hospitalizations and 5,000 fatalities.[9]

With the FDA still struggling to regain the agency’s pre-pandemic diligence, it’s incumbent on manufacturers to double down on food safety. Digitization—evolving from paper to relevant, real-time data—is a critical component of the path forward to improve safety and increase ingredient agility.

Technology and automation help manufacturers and suppliers work better together, collaborate on ingredient data, move more quickly and problem solve together. In today’s modern supply chain, more CPGs are investing in partnerships to increase agility and gain more resilience over the shocks we’ve seen the past few years. More flexible and collaborative tools for engaging with global ingredient supplier networks can increase safety while improving bottom line efficiency.

References:

[1] Bottemiller Evich, H. (2022, April 8). The FDA’s Food Failure. Politico.

[2] U.S. Food & Drug Administration. (2022, May 12). Powdered Infant Formula Recall: What to Know.

[3] Muller, M. & Nyler, L. (2022, May 20). How US Baby Formula Monopolies Have Failed Families. Bloomberg.

[4] KHN. (2022, May 27). FDA Chief Suggests Stockpile Of Baby Formula Once Crisis Ends In July. Kaiser Health News.

[5] U.S. Food & Drug Administration. (2021, May). Resiliency Roadmap for FDA Inspectional Oversight.

[6] U.S. PIRG Education Fund. (2022, January 31). Food Recalls Decline in 2021, but That Doesn’t Mean Food is Safer.

[7] Govinfo.gov. (2022, June 13). Formula Shortage Reporting Act of 2022.

[8] Ensuring Safe and Toxic-Free Foods Act of 2022. (2022, May 27). Ensuring Safe and Toxic Free Foods Act.

[9] Centers for Disease Control and Prevention. (2018). Estimates of Foodborne Illness in the United States.

 

FDA

Highlights of FDA’s 2021 Achievements in Food

By Food Safety Tech Staff
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FDA

At the end of his reflection on FDA’s 2021 accomplishments in the food realm, Deputy Commissioner for Food Policy and Response Frank Yiannas stated that he believes collaboration will enable industry to “bend the curve of foodborne illnesses in this decade”. It would be a significant milestone, and in his latest FDA Voices blog, Yiannas reviewed a host of FDA achievements that bring his statement much closer to a reality:

FDA Acting Commissioner Janet Woodcock gives of full report on the agency’s work in the “FDA 2021 Year in Review: Working For You”.

Compare this year’s review with that of 2020, where Yiannas reflected on the agency’s Food Program achievements during the first year of the pandemic and the 10-year anniversary of FSMA.

CDC, FDA, USDA logos

IFSAC to Continue Focus on Finding Sources of Foodborne Illnesses

By Food Safety Tech Staff
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CDC, FDA, USDA logos

The Interagency Food Safety Analytics Collaboration (IFSAC) has published its 2022–2023 Interim Strategic Plan, placing continued emphasis on foodborne illness source attribution for Salmonella, E. coli O157:H7, Listeria monocytogenes and Campylobacter. Over the next year, IFSAC will address several short-term goals surrounding improvement of methods to evaluate and identify foodborne illness source attribution through the use of outbreak and non-outbreak-associated disease data, and continued collaboration with external partners in an effort to boost data access and capabilities. The group will be targeting several efforts in the coming year, including:

  • Analysis of trends related to foodborne disease outbreak-associated illnesses over the past two decades, with a subsequent peer-reviewed journal article that reveals results.
  • Development and improvement of machine-learning methods used to predict food sources of illnesses that have an unknown source. WGS will be used to compare Salmonella isolates of known and unknown sources.
  • Collaboration with FoodNet when assessing key food sources for sporadic Salmonella Enteritidis and Campylobacter illnesses. The group will develop case-control studies using specific FoodNet data.

Formed in 2011, IFSAC is a partnership between FDA, FSIS and the CDC that seeks to strengthen federal interagency efforts and maximize use of food safety data collection, analysis and use. During 2022–2023, IFSAC will publish its yearly reports on foodborne illness source attribution for the previously mentioned priority pathogens.

Food Safety in 2022: Sustainability, Supply Chain Issues, Consumer Preferences and Technology at the Forefront

By Maria Fontanazza
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The ongoing pandemic, food fraud, food insecurity, supply chain disruptions and shortages, maintaining and fostering a robust food safety culture, and foodborne illness outbreaks kept the food industry very busy last year. Looking ahead to 2022, these challenges will continue, but many food companies are becoming better at forecasting and course correcting. During a recent interview with Food Safety Tech, Waylon Sharp, vice president and chief operating officer at Bureau Veritas, discussed trends affecting food safety this year, along with how companies should respond to incoming challenges.

Waylon Sharp, Bureau Veritas
Waylon Sharp leads North American food and agriculture testing, inspection and certification operations at Bureau Veritas.

Food Safety Tech: What challenges did food companies face in 2021 and how can they apply their lessons learned in the new year?

Waylon Sharp: Supply chain disruptions were a big challenge for food companies in 2021, as much of the North American food system is reliant on production or raw materials from international locations. This theme will continue into 2022, as logistics become more costly and challenging from a labor perspective, food companies will naturally gravitate to exploring alternatives. This shift in supply will increase the need for verification of product quality and safety of new suppliers. In addition to, or alternatively, some producers may choose more local options to reduce delays and increase stability of supply.

FST: What are the key trends impacting food safety in 2022?

Sharp: This year we’ll see food safety impacted by sustainability, consumer preferences and health and wellness:

  • Sustainability: Connecting with a purpose will be a key driver for both attracting new customers and enticing top talent to join food organizations. All aspects are critical, including sourcing raw materials, the packaging used, and minimizing the CO2 footprint in production and logistics. Consequently, I suspect there will be bad actors that see the advantage of appearing to be responsible but not doing what they say. Services that hold these organizations accountable will likely continue to grow.
  • Consumer Preferences: Migration to hyper-local, community supporting businesses can be directly correlated to the COVID financial fallout. Buying local helps support the areas we reside in, and this trend will likely persist. The feel-good support should also result in fresher product with less supply chain challenges for consumers.
  • Health & Wellness: Sustainable, plant-based products are expanding in prevalence. Traditional meat alternatives witnessed an increase in volume and new entrants such as seafood alternatives also grew in consumer acceptance. I expect more to launch in 2022 to meet the rising demand for healthy and environmentally conscious alternatives.

FST: What technologies will play a role in helping food companies tackle their biggest hurdles this year?

Sharp: Technology will continue to play an important role in the industry this year. Additional automation and digital tools to manufacture, assess food quality and safety, and distribute food are all likely to grow. Staffing challenges will continue to impact those highly manual production environments and the more work that can be performed without human intervention will gain favor over labor-intensive functions. In addition, remote audits and inspections allow for an experienced individual to assess a situation without traveling and being present on-site to limit human contact.

Recall

FDA Continues Investigation of Listeria Outbreak in Packaged Salad

By Food Safety Tech Staff
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Recall

— UPDATE — January 12, 2022

Dole Fresh Vegetables, Inc. has now issued a voluntary recall of Dole-branded and private label packaged salads processed at its Springfield, OH (product ID lot code “W” and “Best if Used By” date December 22, 2021–January 9, 2022) and Soledad, CA production facilities containing iceberg lettuce.

–END UPDATE —

The FDA and CDC are investigating a multistate outbreak of Listeria monocytogenes illnesses linked to Fresh Express Packaged Salad and Dole Packaged Salad.

Last month Dole Fresh Vegetables issued a voluntary recall for salads processed at its facilities in Bessemer City, NC and Yuma, AZ due to the health risk. The company also temporarily suspended operations at both facilities. The brand names in which the salads were sold under include Dole, Kroger, Lidl, Little Salad Bar, Marketside, Naturally Better, Nature’s Promise and Simply Nature. The products have “Best if Used By” dates between November 30, 2021 and January 8, 2022.

The agencies’ investigation of Fresh Express Packaged Salad resulted in the company stopping production at its Streamwood, IL facility. It also initiated a recall of certain varieties of its branded and private-label salads that were produced at this facility.

The FDA’s investigation into the Listeria monocytogenes outbreak linked to both Dole and Fresh Express is ongoing. Thus far, no deaths linked to the outbreak have been reported.

FDA

FDA’s Foodborne Outbreak Response Improvement Plan Seeks to Expedite Investigations

By Food Safety Tech Staff
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FDA

Today FDA released a plan to help the agency and its partners improve the “speed, effectiveness, coordination and communication” of investigations surrounding foodborne illness outbreaks.

“We know that the 21st century has brought new challenges in identifying, investigating and controlling outbreaks of foodborne disease, but it has also brought new tools to meet those challenges,” stated Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response, and Stic Harris, D.V.M. director of the FDA’s Coordinated Outbreak Response and Evaluation Network in an agency news release. “We also recognize that today’s U.S. food system is large and decentralized, with a broad array of widely distributed products, which we must adapt to in order to help ensure the safety of these products. That is why we are taking steps through this improvement plan to evolve our outbreak investigations to meet modern-day needs using the most modern-day tools available. Our investigations must be faster, more streamlined and more effective to identify, pinpoint and remove contaminated food from the market and identify root-cause factors in the food system to prevent similar outbreaks in the future.”

The Foodborne Outbreak Response Improvement Plan targets four areas that, if improved, will have the greatest effect on foodborne illness outbreaks:

  • Tech-enabled product traceback: Being smarter about using digital technology, regularly, to streamline traceback investigations
  • Root-cause investigations: Adapting and strengthening procedures for conducting root-cause investigations
  • Working with the CDC, USDA’s FSIS and other partners to improve the analysis and distribution of outbreak data (including identifying recurring, emerging and persistent strains of pathogens)
  • Enhancing performance measures across the agency’s food programs to enable better evaluation of the timeless and effectiveness of outbreak and regulatory investigation activities

In addition to this improvement plan, the agency also released “An Independent Review of FDA’s Foodborne Outbreak Response Processes”, which was contracted with the University of Minnesota’s School of Public Health. The independent report played an important role in the development of FDA’s improvement plan.

Emily Newton, Revolutionized Magazine
FST Soapbox

Using Artificial Intelligence May Add More Transparency to the Food Supply Chain

By Emily Newton
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Emily Newton, Revolutionized Magazine

Food industry professionals know how supply chain transparency plays a major role in keeping everything running smoothly. Brand representatives want confirmation that their agricultural partners can fill upcoming orders. If things go wrong and people get sick from what they eat, better visibility is vital in addressing and curbing such issues.

Artificial intelligence (AI) is a critical part of better food supply chain awareness among all applicable parties. This article briefly discusses some interesting examples.

Applying AI to Crop Management

Even the most experienced agricultural professionals know farming is far from an exact science. Everything from pests to droughts can negatively impact a growing season, even if a farmer does anything they can to influence production in their favor.

However, AI can help predict yields, enabling farmers to maintain transparency and set accurate expectations for parties further down the supply chain. That’s especially important in the increasingly popular farm-to-table movement, which shortens how far produce travels and may entail using it on the same day someone picks it.

One newly developed machine-learning tool relies on computer vision and ultra-scale images taken from the air to categorize lettuce crops. More specifically, it captures details about the size, quality, and quantity of the heads. Combining that with GPS allows more efficient harvesting.

Tracing Foodborne Illness

CDC Statistics indicate foodborne illnesses sicken one in six people every year in the United States. FSMA contains rules and actions for food processing facilities to prevent such instances, but outbreaks still happen. AI could be yet another useful mitigation measure.

Researchers at the University of Georgia determined that, since the 1960s, approximately a quarter of Salmonella outbreaks have been from the Typhimurium variation. They trained a machine-learning algorithm on more than 1,300 Typhimurium genomes with known origins. The model eventually achieved 83% accuracy in predicting certain animal sources that would have the Typhimurium genome. It showed the most accuracy with poultry and swine.

Reducing Food Waste

Waste is a tremendous problem for the food supply chain. In the United States, data shows that upwards of 40% of packaged consumables get discarded once they reach the use-by date. That happens whether or not the products are actually unsafe to eat.

However, better visibility into this issue has a positive impact on food distribution. For example, some restaurants give people discounted meals rather than throwing them away. In other cases, grocery stores partner with charities, helping people in need have enough to eat.

Scientists in Singapore have also created an electronic “nose” that uses AI to sniff out meat freshness. More specifically, it reacts to the gases produced during decay. When the team tested the system on chicken, fish and beef, it showed 98.5% accuracy in its task. Using AI in this manner could bring transparency that cuts food waste while assuring someone that a food product is still safe to eat despite the appearance of it being expired based on Best Before’ labeling.

Removing Guesswork From Dynamic Processes

People are particularly interested in how AI often detects signs that humans miss. Thus, it can often solve problems that previously proved challenging. For example, even the most conscientious farmers can’t watch all their animals every moment of the day and night, but AI could provide greater visibility. That’s valuable since animal health can directly impact the success of entire farming operations.

One European Union-funded AI project took into account how animal health is a primary factor in milk production. The tool compared cows’ behaviors to baseline levels and characteristics of the animals at the most successful farms. It then provided users with practical insights for improvement. Europe has at least 274 million dairy cows, and their milk makes up 11%-14% of Europeans’ dietary fat requirements. Those statistics show why keeping herds producing as expected is critical.

AI is also increasingly used in aquaculture. Until recently, fish farming professionals largely used intuition and experience to determine feeding amounts. However, that can lead to waste. One company uses artificial intelligence to sense fish and shrimp hunger levels and sends that information to smart dispensers that release food. The manufacturers say this approach causes up to a 21% reduction in feed costs. Other solutions track how much fish eat over time, helping farmers adjust their care protocols.

Fascinating Advancements in Supply Chain Transparency

These instances are only a sampling of what AI can do to support the food supply chain. Although most of them are most relevant to producers, consumers will likely reap the benefits, too. For example, some food labels already show the precise field associated with the potatoes used for a bag of chips. Once technology reaches a point where most consumers could have advanced AI apps on their phones, it could be a matter of aiming a smartphone’s camera at any food product and instantly seeing the path it took before reaching the consumer. It’s too early to know when that might happen. Nevertheless, what’s already possible with innovative technology is compelling in its own right and makes people rightfully eager to see what’s on the horizon.

Recall

Onions Named as Source of Salmonella Outbreak, Distributors Agree to Recall

By Food Safety Tech Staff
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Recall

— UPDATE October 22, 2021 — Keeler Family Farms, based in Deming, New Mexico, also issued a voluntary recall for red, yellow and white onions imported from Chihuahua, Mexico and shipped from July 1 through August 25. Thus far no onions from Keeler Family Farms have tested positive for Salmonella.

— END UPDATE —

The source of the fast-growing Salmonella outbreak reported late last month has been identified: Fresh whole red, white and yellow onions imported from Chihuahua, Mexico and distributed by Illinois-based ProSource Inc.

Since late last month, the outbreak has grown from 29 to 37 states (However, the products were distributed nationwide), and from 280 to 652 reported illnesses. According to the CDC, the last of the onions were imported into the United States on August 27 (note, the import date ran from July 1 until August 27). However, businesses and consumers keep onions in storage for up to three months.

Illness subclusters have been linked to restaurants and food service locations. FDA is currently working to determine if these onions have also been distributed to customers via grocery stores. The agency is also continuing to traceback investigations to determine whether more products or suppliers have been affected by the contamination.

“ProSource Inc. has agreed to voluntarily recall red, yellow, and white onions imported from the State of Chihuahua, MX, with import dates from July 1, 2021 through August 27, 2021. Descriptions of these onion types include, but are not limited to, jumbo, colossal, medium, and sweet onions. Additional recall information will be made public as soon as it is available from ProSource Inc.,” according to recall information posted on FDA’s website.

Currently no deaths have been reported, but 129 people have been hospitalized. The last illness onset recorded was September 30.

FDA

FDA Releases Results of Sampling Assignment of Romaine Lettuce from Yuma, Arizona

By Food Safety Tech Staff
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FDA

As part of its efforts to prioritize the safety of leafy greens, the FDA released the results of a sampling assignment involving testing romaine lettuce from commercial coolers in Yuma County, Arizona. Earlier this year the agency announced that it would be collecting samples of romaine lettuce as part of ongoing surveillance following the spring 2018 multistate outbreak of E.coli O157:H7.

The lettuce was tested for Shiga toxin-producing Escherichia coli (STEC), specifically enterohemorrhagic Escherichia coli (EHEC), and Salmonella spp. The FDA collected 504 romaine samples, and an independent lab conducted the testing.

E.coli O130:H11 was found in one sample, and as a result, the FDA conducted an investigation at the farm to find potential sources and routes of contamination—samples of soil, water, sediment and animal fecal material were taken, and the agency also looked at farm equipment and other surfaces. Out of 24 samples, just one came back positive for STEC, and this sample was taken from the outer leaves of the lettuce. It was determined that the strain was low risk to human health, and FDA did not find that this strain was linked to any past known foodborne illness outbreaks.

“The agency’s goal in conducting this assignment was to determine whether the target pathogens and specific strains may be present in romaine lettuce from the Yuma agricultural region, to help prevent foodborne illness when possible,” FDA stated in a constituent update. “If product that tested positive for EHEC or Salmonella was found, the Agency planned to work with industry and state regulatory partners to identify the cause (e.g., farm follow-up investigation) to inform future regulatory and/or research efforts and to develop strategies that could help preventive additional outbreaks.”

STOP Foodborne Illness

STOP Foodborne Illness Kicks Off National Food Safety Education Month with STOP3000 Campaign

By Maria Fontanazza
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STOP Foodborne Illness
Mitzi Baum, Stop Foodborne Illness
Mitzi Baum, CEO, STOP Foodborne Illness, will moderate a panel about STOP’s Recall Modernization Working Group during an episode of the 2021 Food Safety Consortium Virtual Conference Series. Join us on Thursday, October 14.

Each year the CDC estimates that more than 3000 people die as a result of contracting a foodborne illness. This month—National Food Safety Education Month—STOP Foodborne Illness is launching a fundraising campaign to educate the broader community about the issue, by encouraging participants to take 3000 steps per day.

STOP3000 begins today and runs through the entire month of September. This fundraiser will help STOP Foodborne Illness in its continued efforts to push food safety initiatives forward while engaging with key industry stakeholders, including federal regulatory agencies, food manufacturers, food retailers and the food service community.

“This is a way for everyone to participate in raising awareness about food safety,” Mitzi Baum, CEO of STOP told Food Safety Tech. “It’s about how you can make small changes in your daily habits to reduce the incidence of foodborne illness. People can sign up to walk, ask friends and family to post on their social media, or you can make a donation. Each day we’ll push out food safety facts and information, so you’re getting a little bit of knowledge every day during National Food Safety Education Month.”

If you’re interested in participating in the campaign, you can sign up on the JustGiving website. You can also search for and donate to current participants by typing “STOP3000” into the Search box on the JustGiving site.