Tag Archives: foodborne illness

Stephen Ostroff, FDA

Pathogens, Partnerships and FSMA: Where FDA Is Headed

By Maria Fontanazza
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Stephen Ostroff, FDA

This year is a big year for food safety at FDA. All seven of the FSMA rules have been finalized, and the first compliance date is right around the corner (compliance with the Preventive Controls for Human Food rule starts in September for large companies). Stephen Ostroff, M.D., just took the helm from Michael Taylor as the agency’s deputy commissioner for foods and veterinary medicine. And finally, FDA is taking a hard line in both improving the tools and methods used to detect outbreaks as well as working with the Department of Justice to prioritize enforcement actions against companies that introduce adulterated foods into the supply chain.

Yesterday Ostroff provided an update on FDA’s recent initiatives and its plan of action to achieve success in FSMA implementation and pathogen detection at the IAFP annual meeting in St. Louis. Ostroff highlighted several tenets of FSMA:

  • Keys to FSMA success will be dependent upon achieving high rates of compliance
  • Domestic and import parity
  • Education before and while regulating (establishment of training and education networks)
  • Taking a risk-based approach to inspection and planning
  • Partnerships are critical
Stephen Ostroff, FDA
FDA’s Stephen Ostroff will be the opening keynote at the 2016 Food Safety Consortium, December 7 in Schaumburg, IL. LEARN MORE

Industry can expect three more rulemakings as required by FSMA in the areas of lab accreditation, a reportable food registry and product tracing. In addition, FDA is working on guidances related to the preventive controls, produce, and foreign supplier verification program rules. “We’re tantalizingly close so stay tuned,” Ostroff said.

Expect to see more program alignment with the Office of Regulatory Affairs as well. The inspection and compliance staff will be trained as specialists and there will be horizontal integration of programs between field activity and agency headquarters. Although the next fiscal year will be a transition year, Ostroff is hopeful that changes that need to be made at the agency, along with program alignment, will be in place by fiscal year 2018.

Other notable actions at FDA over the past year include:

  • In response to the OIG’s conclusion that FDA’s food recall program is not efficient or effective, the agency is ramping up its use of the strategic CORE (Coordinated Outbreak Response and Evaluation) network in order to examine recalls that might not be moving as smoothly or quickly as the agency prefers. FDA is also leveraging greater application of whole genome sequencing (WGS).
  • GenomeTrakr network and WGS. More than 50,000 genome sequences have been added to the database (largely Salmonella). Ostroff called WGS a game changer that holds the opportunity to more quickly identify problems and detect outbreaks while they’re still quite small. In partnership with the CDC, FDA set up a successful module for WGS of Listeria and the agency hopes to expand the model for use with other pathogens.
  • Nutrition (Not just what consumers are eating, but how much of it): The move that declared partially hydrogenated oils as no longer GRAS with compliance required by 2018.  The agency also issued a final guidance on menu and vending labeling in May, issued levels for arsenic in infant rice cereal, made determination for folic acid fortification in corn/masa, made revisions to nutrition facts labels that takes effect in 2018, issued a draft guidance on voluntary sodium reduction, and will continue to exam the terms “natural” and “healthy”.
  • Genetic engineering. FDA approval of GE salmon following one of the longest reviews in the history of FDA (20-year review), along with issuing voluntary labeling guidance.
  • Monitoring antimicrobial resistance through NARMS  (National Antimicrobial Resistance Monitoring System). FDA will be collecting antimicrobial sales by species and, in cooperation with USDA, hopes to release farm-based data about antimicrobial use at the farm level.

Ostroff emphasized FDA’s strategic 10-year plan, released this year, pointing to public health as a first priority, maintaining partnerships as a key to success (including re-establishing overseas offices), continuing research as a foundation, and maintaining transparently.

Deirdre Schlunegger, CEO of STOP Foodborne Illness
Food Safety Culture Club

We Know the Why

By Deirdre Schlunegger
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Deirdre Schlunegger, CEO of STOP Foodborne Illness

Food safety culture is not just a catchy phrase or the right thing to say. It is the right thing to embrace and the right thing to implement. But how is it achieved? It is relevant to start with understanding “The Why” behind food safety. Why is it important?  Do people really get sick and die? Why does that happen, and what is our role in preventing it?  How do we integrate aspects of FSMA with a culture that embraces a robust food safety culture, and how do we create passion around the culture?  I continue to address this issue, because at nearly every meeting I attend, in committees in which I serve and in simple conversations with colleagues, I hear the frantic voices of those who have so much to do, results to produce, bosses to please, and staff to supervise, and the why behind food safety is rarely mentioned.

STOP Foodborne Illness, Why Behind Food Safety
We need to truly understand the “why: behind food safety.

I speak to and read about individuals daily who have been sick or lost children or parents to this preventable problem. I see the photos of their children and hear about their loving attributes, yet this aspect is often neglected in the equation of the busy lives of those involved in growing, producing and distributing our food. I get it—who wants to talk about the problem when there is a product to promote and sell? But in reality, the only reason any of us live this frantic life with a long to-do list is because people get sick and die from foodborne illnesses, and because it is our job to do what we can to prevent the illnesses. And while consumers can practice safe food handling, there is nothing they can do about Salmonella in peanut butter, or Listeria in ice cream, cantaloupe or caramel apples. Let’s start the conversation of HOW to change and sustain a strong food safety culture and include the why as our rationale in the conversation.  STOP Foodborne Illness is interested and will devote more time to the how, and I hope you will join us in this conversation and endeavor. I would love to hear your thoughts.

USDA Logo

USDA Touts Food Safety Progress Under Obama Administration

By Food Safety Tech Staff
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USDA Logo

Between 2009 and 2015 there was a 12% reduction in foodborne illnesses associated with meat, poultry and processed egg products. “We’re better now at keeping unsafe food out of commerce, whether it’s made unsafe because of dangerous bacteria, or because of an allergen, like peanuts or wheat,” said Agriculture Secretary Tom Vilsack in a USDA release. “Over the course of [President Obama’s] Administration, we have tightened our regulatory requirements for the meat and poultry industry, enhanced consumer engagement around safe food handling practices, and made smart changes to our own operations, ultimately moving the needle on the number of foodborne illness cases attributed to products that we regulate.”

USDA’s Food Safety and Inspection Service (FSIS) has implemented a number of initiatives since 2009, including:

  1. Establishing a zero-tolerance policy for raw beef products that contain shiga-toxin producing E. coli: O26, O103, O45, O111, O121 and O145.
  2. Labeling mechanically tenderized meat. The blades or needles used to tenderize meat an introduce pathogens into the meat.
  3. First-ever pathogen reduction standards for poultry parts in order to reduce consumer exposure to Salmonella and Campylobacter. The standard is expected to prevent 50,000 cases of foodborne illness each year.
  4. Requiring that all poultry facilities create a plan to prevent contamination with Salmonella and Campylobacter, instead of addressing the problem after it occurs. Poultry companies must collect samples at two points in the production line and test them to show control of enteric pathogens.
  5. Requiring meat and poultry companies to hold all products that are undergoing lab analysis until USDA microbial and chemical tests for harmful hazards are complete.
Recall

More E. Coli Illnesses, General Mills Expands Flour Recall

By Food Safety Tech Staff
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Recall

Consumers should check their pantry. As a result of newly reported illnesses connected to raw dough or batter consumption, General Mills has expanded its recall of Gold Medal flour, Wondra flour and Signature Kitchens flour to include products made last fall. The FDA and CDC have warned consumers against eating any raw products made with flour.

According to the CDC, the multi-state outbreak of Shiga toxin-producing E. Coli O121 has sickened at least 42 consumers (with 11 hospitalizations) across 21 states. No deaths have been reported. The bacteria was isolated from samples of General Mills flour that was collected from the homes of those sickened in Arizona, Colorado and Oklahoma.

General Mills has already conducted a voluntary recall of 10 million pounds of flour (unbleached, all purpose and self rising). A full list of the products included in the recall are available on FDA’s website.

Deirdre Schlunegger, CEO of STOP Foodborne Illness
Food Safety Culture Club

Spreading the Message

By Deirdre Schlunegger
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Deirdre Schlunegger, CEO of STOP Foodborne Illness

STOP Foodborne Illness receives many requests to speak at conferences, trainings and meetings.  I recently spoke at the Harris County Food Safety Summit  in Houston, along with David, one of our Texas volunteers. David became ill from Salmonella after eating at a hospital. The event’s audience consisted of health inspectors, and restaurant owners and managers. It was a great crowd.

At this year’s Food Safety Consortium, STOP Foodborne Illness is holding a fundraiser and honoring heroes in food safety. LEARN MOREAt the United Fresh meeting, I participated on a panel with Rylee, a STOP Nevada volunteer, who spoke about her experiences as a victim of a foodborne illness.  Also include on the panel were folks from The California Leafy Green Marketing Agreement to talk about our collaborative training video project. STOP Board Member Jorge Hernandez, also the Chief Food Safety Officer for Wholesome International, moderated the discussion. The video was played (available on STOP’s website). I was asked what I thought about competitive marketing advantage as it relates to food safety. To be honest, I don’t really think about that: STOP Foodborne Illness has an obligation to do what we can to prevent illness and death that stems from foodborne illness. We know that sharing personal stories makes a difference in training.

Now that I’m back in the office, our team has three requests, one for speaking and two requests from media to talk about food safety. We hear a lot about food safety culture these days, but actually taking the steps to facilitate, implement and monitor that change can be more of a challenge. We are reading about so many new technologies and practices related to food safety, which is great, but they must be accompanied by a company’s knowledge and commitment in order to be successful.

We will continue to contribute to the conversation. We are most interested in prevention and in solutions and like you, want to make a difference. We want to have fewer and fewer conversations with devastated family members about their experience with foodborne illness.  Thanks again for all you do to create a strong food safety culture. How is your organization instilling a strong culture? Let us know how we can help.

FDA, CDC

Study Makes Connection Between Outbreak Data and Foodborne Illnesses

By Food Safety Tech Staff
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FDA, CDC

Outbreak illnesses and sporadic illnesses have similar traits. In addition, outbreak data can be used to assess the foods that are most frequently connected to particular foodborne illnesses. This analysis, all according to a recent study by the Interagency Food Safety Analytics Collaboration (IFSAC), could aid in improving the progression of science as well as provide a better understanding of the role of sporadic foodborne illnesses and their relation to an outbreak.

Scientists from IFSAC published the paper, “Comparing Characteristics of Sporadic and Outbreak-Associated Foodborne Illnesses, United States, 2004-2011”, in a July 2016 issue of Emerging Infectious Diseases. They collected data from the CDC’s Foodborne Diseases Active Surveillance Network (FoodNet) and compared outbreak illnesses with sporadic illnesses.

Available on the CDC’s website, key findings of IFSAC’s analysis include:

  • Campylobacter, Listeria monocytogenes, and E. coli O157 outbreak illnesses are not significantly different from sporadic illnesses with respect to patients’ illness severity, gender, and age.
  • Salmonella outbreak illnesses are not significantly different from sporadic illnesses with respect to illness severity and gender. For age, the percentages of outbreak and sporadic illnesses that occur among older children and adults are also similar. The percentage of outbreak illnesses in the youngest age category (0-3 years) was significantly lower compared to other age groups.
Dave Shumaker, GoJo
Retail Food Safety Forum

Navigating the Complexities of Common Foodborne Illnesses

By Dave Shumaker
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Dave Shumaker, GoJo

Did you know there are more than 250 different types of foodborne illnesses? And while that number may seem daunting, especially when one in six Americans become ill from consuming contaminated foods or beverages each year, there are a few foodborne germs that are responsible for the majority of illness outbreaks, according to the CDC.1 What are these illnesses? What are their symptoms? What can you do to help reduce the risk of an outbreak happening at your restaurant?

The CDC estimates that approximately 48 million people get sick from a foodborne illness each year, with 128,000 hospitalizations and 3,000 deaths. And of these numbers, there are two common illnesses that stand out—norovirus and Salmonella. In fact, these two pathogens account for nearly 70% of all foodborne illness outbreaks in the United States.

Norovirus

Norovirus is responsible for 58% of domestically acquired foodborne illnesses and nearly half of all foodborne disease outbreaks due to known agents.2 Of these instances, most norovirus outbreaks occur in a food service setting, particularly restaurants.

Oftentimes, infected employees are the cause of these types of outbreaks. For example, individuals who are exhibiting symptoms come to work and contaminate food by touching either ready-to-eat foods or food-contact surfaces with their bare hands, which can lead to cross contamination.

Norovirus spreads easily and quickly, so people can contract it by not only by consuming contaminated foods or beverages, but also from having direct contact with individuals who are infected with the virus or touching surfaces or objects that have norovirus on them as well. In addition, norovirus outbreaks can also occur from foods that are contaminated at their source.2

In this video about Norovirus, I discuss the actions you can take, which includes practicing good hand hygiene, to reduce the risk of a norovirus outbreak negatively impacting your restaurant.

Salmonella

Each year in the United States, Salmonella is responsible for 1 million foodborne illnesses, 19,000 hospitalizations and 380 deaths.3 In fact, the pathogen accounts for 11% of all foodborne illnesses in the United States.

People become infected with Salmonella by either eating contaminated food that has not been properly cooked or has been contaminated after preparation.4 Salmonella is often found in raw food products that come from animals such as eggs, meat, and unpasteurized milk and dairy products.

While Salmonella is fairly common, measures can be taken to help reduce the risk of infection, such as through proper cooking and holding temperatures. In addition, proper disinfection and sanitization of food contact surfaces (i.e., countertops and cutting boards) helps reduce the risk of cross contamination. Practicing good hand hygiene before eating, and before and after preparing food can also help prevent the spread of this bacterium.

No one ever thinks their restaurant will fall victim to a foodborne illness outbreak, but it can happen and these outbreaks are more common than you may think. It is critical for you to share information about foodborne pathogens and prevention with your staff. This type of education and training can have a significant benefit to your restaurant.

References

  1. Centers for Disease Control and Prevention. Foodborne Germs and Illnesses. Accessed May 8, 2016. Retrieved from http://www.cdc.gov/foodsafety/foodborne-germs.html
  2. Centers for Disease Control and Prevention. Burden of Norovirus Illness and Outbreaks. Accessed May 8, 2016. Retrieved from http://www.cdc.gov/norovirus/php/illness-outbreaks.html
  3. Centers for Disease Control and Prevention. Salmonella. Accessed May 17, 2016. Retrieved from http://www.cdc.gov/salmonella/
  4. Vermont Department of Health. Salmonella. Accessed May 23, 2016. Retrieved from http://healthvermont.gov/prevent/salmonella/Salmonella.aspx

OIG Says FDA Recall Initiation Process Not Efficient or Effective

By Food Safety Tech Staff
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As a result of an ongoing audit of FDA’s food recall program, the Office of Inspector General (OIG) has concluded that FDA does not have the policies and procedures in place to ensure that voluntary food recalls are initiated in a prompt manner.

“This issue is a significant matter and requires FDA’s immediate attention,” the letter stated. “We suggest that FDA update its policies and procedures to instruct its recall staff to establish set timeframes for (1) FDA to request that firms voluntarily recall their products and (2) firms to initiate voluntary food recalls.”

The audit follows a report from June 2011 that reviewed FDA’s monitoring of imported food recalls. That particular report also found the agency’s food recall program to be inadequate due to the fact that FDA did not have the authority to require companies to recall certain foods. FSMA has changed this aspect of recall authority.

The OIG’s letter, addressed to FDA Commissioner Robert Califf, M.D., specifically calls out two recall cases:

  • A nut butter recall due to Salmonella in which 14 people became ill. According to the OIG, 165 days passed from the time FDA identified the adulterated product to the time the company initiated a recall.
  • Several recalls of cheese products due to Listeria monocytogenes in which 9 people became ill and one infant died. In this situation, 81 days passed from the time FDA was aware of adulterated product to the time the company recalled the products.

The OIG issued the letter to Califf as an early alert. The audit of FDA’s food recall process is continuing and the OIG will be issuing a draft report at the conclusion of the audit.

Randy Fields, Repositrak
FST Soapbox

Insurance and Food Safety: A Primer for the C-Suite

By Randy Fields
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Randy Fields, Repositrak

Food safety risk is now a greater concern for retailers and manufacturers than ever before due to the combination of FSMA and increased consumer concerns. Supply chains are more complex, product recalls and foodborne illness outbreaks occur more frequently, and the new normal is prevention rather than inspection. Wrap that all up with advanced technology and the 24-hour news cycle, and consumers are acutely becoming aware of food safety issues as soon as they occur.

What this means for all of the participants in the global food supply chain is that you should review your insurance policies and look for gaps in coverage where you may be exposed. While no two recalls are the same, and foodborne illness outbreaks impact affected companies in different ways, certain trends have emerged to help better understand the claim friction points that frustrate companies after a food safety event.

Two of the most important tools to mitigate food safety risk are contaminated product insurance (CPI) and product recall insurance (PRI). Inventory, cost of refunds and recall expenses are three of the largest recall loss items suffered by companies. Combined, they are the largest percentage of loss (nearly 50%) and represent a substantial portion of uncovered loss for any insured under CPI/PRI. The sole basis for this frustrating friction point is simple—lack of traceability.

CPI/PRI only covers losses that result directly from a covered insured event. If a company is unable to support its claim that costs are directly related to the event and the resulting recall or outbreak, it will not be reimbursed under a CPI/PRI policy. And, as such, loss amounts are generally not covered under general liability and property policies either, so a significant portion of a company’s loss remains uncovered.

Here’s a recent claim example to illustrate the impact on a company that lacked the capability to properly trace its products. An insured purchased a CPI policy with a $2 million Accidental Contamination limit. An event occurred involving a contaminated food product, which triggered that coverage. During the review, the insured provided spreadsheets supporting nearly $1.1 million in customer credits for product shipped and either returned by the customer for disposal or destroyed by the customer. Unfortunately, based on a review of the information provided in support of the spreadsheets, the accountants found that the insured was unable to properly trace and support its claim that the returned or destroyed product was affected by the insured event recall. Under these circumstances, the accountants were only able to confirm $187,000 in losses. The result: The company was unable to recover nearly $1 million in potentially covered losses because it lacked traceability. These outcomes are not uncommon.

The insurance industry understands food safety risks and the need to evolve products to meet the needs of food industry clients. Companies can’t totally mitigate all food safety issues, but understanding the risks is the best way for a business to protect itself. Insurance industry leaders are working in partnership with their food sector clients to ensure that risks are better understood and that the client has appropriate systems in place to help mitigate them.

Insurance companies are tailoring their products to ensure that policies are developed to address the recall risks caused by regulatory changes and help companies ensure compliance as well as an understanding of the regulatory requirements. However, food companies may increasingly find coverage and limits adjusted lower for government recalls in high-risk environments. Insurers are also a key player in the promotion of food safety standards, and some offer favorable rates to food industry clients who are graded top tier for safety.

Some insurers go a step further, allowing clients to allocate a portion of their premium for pre-incident risk-analysis and crisis-response services. Top insurers provide clients access to a network of crisis management specialists as part of their food safety coverage. They should offer risk management guidance in areas such as food safety risk, regulatory compliance, supply chain management and product security.

One of the most critical risk mitigation tactics is developing long-term relationships with trusted, but verified, suppliers, distributors and other key partners. It is also important for companies to undertake regular site visits to their manufacturers or suppliers, and commission third-party audits to maintain reliability and transparency.

Not if, but when a product recall occurs, a company faces a myriad of risks. As with food safety, preventive planning can pay off significantly. By proactively working with insurers, trading partners and technology vendors you can reduce if not eliminate the negative impact of the event.

International Brotherhood of Teamsters

Supplier Accountability Focus of Latest Protest Against Chipotle

By Food Safety Tech Staff
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International Brotherhood of Teamsters

The labor union International Brotherhood of Teamsters has been holding nationwide protests at Chipotle locations this month, taking issue with one of the restaurant chain’s suppliers. The supplier at the focus of the demonstrations is California-based produce company Taylor Farms, which supplies tomatoes and peppers to Chipotle, according to Teamsters.

“Over the past five years, Taylor Farms has had more than 20 food recalls for problems such as Listeria, Salmonella and E. coli. In November 2015, Taylor Farms products containing celery and sold at Costco and other retail outlets were recalled for possible E. coli 0157:H7 contamination,” according to a Teamster news release. “At Taylor Farms’ plant in Tracy, Calif., the company has also committed safety and health violations and violations of laws that protect workers’ rights. Recently, the company settled extensive labor rights violations that involved payments of $267,000 to illegally terminated workers and a required posting in which the company promises to never again violate a long list of employee rights.”

The Teamsters protested at 12 Chipotle locations across the country, following 30 previous protests at Chipotle over the past several months.

Teamster Vice President Rome Aloise points the finger at Chipotle for allowing Taylor Farms to “have a total disregard for consumers’ and workers’ health and safety, as well as workers’ rights,” he said. “Chipotle claims to serve ‘Food With Integrity’, but where’s the integrity when it turns a blind eye to its supplier’s behavior? Chipotle must not cut and run – which would hurt Taylor Farms workers – it must carry out its social responsibility and demand Taylor Farms treat workers fairly and with respect.”

Taylor Farms has not released a statement addressing the protests.