ConAgra Subsidiary Slapped with Largest Criminal Fine Ever in Food Safety Case

By Food Safety Tech Staff
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Earlier this week ConAgra Grocery Products, LLC, a subsidiary of ConAgra Foods, Inc., was sentenced to pay $11.2 million after pleading guilty to a criminal misdemeanor charge related to shipping peanut butter contaminated with Salmonella. The $8 million criminal fine and forfeiture of $3.2 million in assets is the largest fine ever paid in a food safety case, according to the Department of Justice.

“This case demonstrates companies – both large and small – must be vigilant about food safety,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division in a release.  “We rely every day on food processors and handlers to meet the high standards required to keep our food free of harmful contamination.”

Stephen Ostroff, 2016 Food Safety Consortium
WATCH THE VIDEO: Stephen Ostroff, M.D., FDA deputy commissioner for foods and veterinary medicine discussed the agency’s take on criminal liability at the 2016 Food Safety Consortium

ConAgra admitted that it introduced contaminated Peter Pan and private label peanut butter into interstate commerce (produced and shipped from the company’s facility in Sylvester, Georgia) during an outbreak of Salmonellosis in 2006. The company also admitted that it had been previously aware of the risk of Salmonella contamination in peanut butter dating back to 2004. Among the culprits of the contamination (as identified by company employees) were an old peanut roaster that did not uniformly heat the raw peanuts, a sugar silo damaged by a storm, and a leaky roof that permitted moisture to enter the facility, followed by airflow that may have pushed the contamination throughout the plant.

The company tried to address some of the issues, but the DOJ stated that ConAgra did not fully correct the situation until after the 2006–2007 outbreak.  “While ConAgra did take corrective action eventually, by failing to timely recognize and rectify the problem of salmonella contamination, this company damaged the health of both public consumers and of the agricultural industry overall.  I commend my staff, that of the Consumer Protection Branch of the Civil Division of the U.S. Department of Justice, and the investigators of the FDA, for the excellent work by all in bringing this incident to this conclusion and I hope that it will serve as a reminder to others in the industry of the high cost of failing to protect the public that relies on them to properly meet this responsibility.”

Watch Out, DOJ and FDA Prioritizing Prosecution

Melanie Neumann, Neumann Risk Services

Risk Mitigation and Compliance Management Strategies – Tightly Intertwined but Very Different!

Melanie Neumann, Neumann Risk Services

Melanie Neumann of Neumann Risk Services, LLC, (NRS) a global food safety and compliance law firm shares her thoughts on the similarities and differences of risk mitigation and compliance management, as well as the year ahead and what companies should be focusing on with regard to these key risk management topics.

Q.  Risk Mitigation and Compliance Management are often grouped together – in your view what is the key distinction between the two?

A.  The two are very much linked and very much codependent yet they are separate topics that need to be identified, implemented and managed differently.  Independent strategies need to be put together that are different, separate and apart based upon a company’s strategy and risk tolerance.  [more]

Q. What risk mitigation approach is most realistic, and typically deployed by the food & beverage industry?

A.  With risk management, there are 4 types of risk mitigation strategies that are typical. I’ll break down to how you can manage risk very simply – 1) avoid it, 2) limit it, 3) transfer it, and 4) if you can’t do any of these 3, you can accept it.  [more]

Q.  How does your risk management strategy tie into compliance management?

A. Tying it together, risk management identifies the risk, and establishes a way to manage that risk appropriately. Compliance management is assessing whether the process of managing that risk is actually working the way you intended it, and is meeting laws or regulatory requirements if there are any that apply.  [more]

Q.  What are some of the key risk mitigation and compliance management considerations and initiatives companies should be thinking about in 2017?

A.  As companies continue to develop and execute upon their risk mitigation and compliance management strategies – they should be focusing on: 1- Showing your work; and 2 – leveraging your data for positive outcomes.  [more]

Q. Any parting thoughts on what you’ve shared today?

A. Right now, frankly, the stakes are higher than ever.  Liability concerns are greater than ever, too.  “knowledge” is being imputed on companies more than ever before for food safety issues that occurred in the past and rear its head again in the future.  [more]

Learn how SafetyChain’s solutions can help you more effectively reduce risk and ensure program compliance – www.SafetyChain.com

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Hygiena to Acquire DuPont’s Food Safety Diagnostics Business

By Food Safety Tech Staff
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In an agreement expected to close in Q1 2017, Hygiena, a provider of rapid food safety and environmental sanitation testing, is acquiring Dupont’s global food safety diagnostics business. Financial terms of the deal were not disclosed.

The acquisition includes DuPont Diagnostics’ BAX system for pathogen detection (used globally by food manufacturers, quality labs and governments worldwide) and RiboPrinter Systems, the company’s globally and technically trained sales, R&D and manufacturing, and its in-house production capacity.

“The combination of DuPont Diagnostics and Hygiena will create a broad food safety diagnostics company that can better serve our customers, said Steve Nason, CEO of Hygiena in a press release. “The combined company’s microbiology products will cover the full manufacturing process, from in-process environmental tests to finished products tests.”

Hygiena is a portfolio company of private equity firm Warburg Pincus. Its products are distributed in 80 countries and include rapid hygiene monitoring systems, environmental collections systems, and its ATP testing system.

Scott Mahloch, FBI, Food Safety Consortium

FBI Says Terrorists May Target Food Sector

By Maria Fontanazza
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Scott Mahloch, FBI, Food Safety Consortium

Many people associate terrorism with spectacular attacks such as those that occurred on September 11. However, lone wolf attacks are far more likely to happen in what has unfortunately become the new normal. “The last thing on your mind is a terrorist being interested in food. It does exist, and bad guys do have an interest in this area,” said Special Agent Scott Mahloch, weapons of mass destruction coordinator for the Chicago division of the FBI during the Food Safety Consortium last week. What does this mean for the food industry?

SA Scott Mahloch will present FBI’s Role in Food Defense on November 29 at the 2017 Food Safety Consortium | Learn moreAccording to the Department of Homeland Security, with 2.2 million farms and 900,000 restaurants in the United States, the food and agricultural sector accounts for 1/5 of the national economic activity. There are several industry targets for terrorism: Food processing facilities; food storage and distribution; restaurants, grocery stores and markets; commercial facilities; and cruise lines.

While Mahloch emphasized that there is no imminent threat to the food sector, one of the biggest areas of concern for this particular industry is the insider threat. “The insider threat is that person [who] knows the facilities, processes, distribution network and can cause the greatest impact,” said Mahloch. This can be in the form of a disgruntled employee who has or can gain access to equipment or other areas of a facility that would otherwise be secure and then introduce contaminants into food products. Mahloch stressed the important role that a food company plays in monitoring employees and reporting any deviation from normal behavior. This is not an easy task—in fact, it is the most difficult threat to detect, and the most difficult threat to protect against, Mahloch pointed out.

Insider Threat: The threat posed by an individual who exploits his/her position, credentials or employment to achieve trusted access to the means, processes, equipment, material, location, facility and/or target necessary to carry out a terrorist action.

The likelihood of an employee becoming an insider threat increases with a variety of personal factors, including financial need, feelings of anger or revenge, being a sympathizer with terrorist ideology, having problems at work, compulsive and destructive behavior, ego and family issues. Food organizations also open themselves up to vulnerabilities via the following:

  • Allowing easy access to restricted or sensitive areas within a facility (i.e., not limiting personnel access to certain areas or clearly labeling access controls)
  • Failure to have physical security controls over personal items that are either brought into or taken from the workplace
  • Vague security policies/Lax security perception
  • High employee turnover
  • Lack of proper employee vetting
  • Failure to train employees in proper security protocols
  • Failure to have consequences for violating security policy

Surveillance

When assessing the insider threat, what should food companies look for in an effort to protect their facility and products? “You’re the first line of defense,” said Mahloch. “We get a lot of phone calls where people run things by us. If something doesn’t seem right, say something.” He provided several key behaviors that may be characterized as suspicious in some instances:

  • Someone taking a photograph or video, or notes/sketches, of food processing operations or sensitive areas
  • Someone attempting to gain information about company operations, especially related to security and personnel, in person, or by phone or email
  • Someone conducting surveillance of self services areas such as salad bars, condiment stands or open bulk containers
  • Shipping area: Unscheduled deliveries, driver who is unfamiliar with facility delivery protocols, items left on dock at unusual hours, illegally parked or unattended vehicles, or shipping documents that don’t match

Be Proactive

Companies can take several preventive steps to protect their facilities, products and personnel. Proactive measures include:

  • Monitoring products for evidence of tampering, resealing or damage
  • Securing open containers of food or ingredients in storage areas
  • Controlling access to specific areas of facility by delivery personnel, employees, vendors and contractors, and general visitors
  • Securing loading dock area, and standardize delivery and pickup protocol
  • Developing a written food defense plan
  • Training employees, contractors and vendors to recognize suspicious activity and report it accordingly

Take Action

It’s important to stay alert and be aware—employee observations are critical, said Mahloch. Once suspicious activity is observed, the facility security officer or manager should be notified, and from there a decision can be made on whether external parties need to be involved. In general, state and local partners investigate an incident before the FBI gets involved.

“When it comes to intentional contamination [or a] terrorist incident—that’s an area that we investigate and ultimately prosecute,” said Mahloch. He emphasized the FBI is not a regulatory agency, so it would not show up at a facility due to a company’s lack of compliance to FSMA, for example. The agency is interested in food defense and intentional contamination that has the purpose of causing harm.

For more information about the FBI’s role in food defense, the agency has a document on its website that summarizes food defense for the industry, including some of the above-mentioned factors to look for when trying to identifying suspicious behavior. If a company wants to report suspicious activity that is not an emergency, it can call 1-855-TELL-FBI (1-855-835-5324).

Stephen Ostroff, 2016 Food Safety Consortium

FDA’s Take on Criminal Liability

By Food Safety Tech Staff
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Stephen Ostroff, 2016 Food Safety Consortium

Stephen Ostroff, M.D. will keynote at the 2017 Food Safety Consortium | Learn moreCriminal liability has been a hot topic in food safety over the past year. During the 2016 Food Safety Consortium, FDA Deputy Commissioner for Foods and Veterinary Medicine Stephen Ostroff, M.D., clarified FDA’s stance on enforcement.

“Our goal is for us to promote food safety, not to resort first and foremost to enforcement actions,” said Ostroff.

For Ostroff’s full comment, watch the video.

FSC 2016, Audits panel

Collaborating on Food Safety: Images from the 2016 Consortium

By Food Safety Tech Staff
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Image credits: amyBcreative

FDA on Enforcement: Our Goal is To Help, Not Punish

By Maria Fontanazza
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Over the past year and a half, much attention has been given the federal government’s commitment to prioritizing prosecution of food companies that engage in criminal behavior. In some instances, this has been used as a scare tactic, shining a spotlight on the executive responsibility of company executives.  Although focusing on executive liability isn’t necessarily a bad thing, Stephen Ostroff, M.D., deputy commissioner for foods and veterinary medicine at FDA, wants food manufacturers to know that FDA isn’t out to get them.

During yesterday’s opening keynote presentation at the 2016 Food Safety Consortium, Ostroff commented on FDA’s approach to enforcement. “I often have to scratch my head as why this has been such a tremendous concern in a regulated industry…sitting at FDA, we have not had any change in our thinking and approach about liability,” said Ostroff. “FDA pursues legal action against companies that are clearly negligent and clearly violating the law.” He emphasized that FDA’s goal moving into the FSMA compliance phase hasn’t changed; it’s about implementing a food safety system focused on preventive controls.

Ostroff encouraged attendees to look at the areas in which their food safety system is vulnerable, take proactive action and build redundancies into their system. “The best defense is to comply with the new requirements, and document how you are creating a food safety culture where everyone understands the expectations,” he added. “If you’re making a good faith attempt—our goal is to help you accomplish that goal, not to punish you for the attempts that you’ve made in good faith.”

The deputy commissioner also commented on the agency’s progress since FSMA’s seven rules were finalized in May, pointing out that these rules are foundational, and additional rules are to come. These rules will address lab accreditation, traceability related to imported products and a reportable food registry tool.

“If when we visit we identify very significant food safety hazards that we think pose an imminent risk of foodborne illness, we will have to take action.” – Stephen Ostroff, M.D.

Other key areas Ostroff discussed regarding agency progress and initiatives included:

  • Initial compliance date for FSMA Preventive Controls Rule (for large companies). FDA wants to be a partner in assisting companies with the preventive controls requirements. “That for us will require a lot of work on the part of those who are going to be conducting these inspections, but our goal is to help you and tell you in which areas you’re doing quite well and in which areas you can do better,” said Ostroff, adding that many of the aspects of the preventive controls rule are very similar to what many companies have already done.
  • Foodborne outbreaks. With several outbreaks in the 2015–2016 timeframe (ice cream–Listeriosis; cilantro–cyclospora; cucumbers­–Salmonellosis; Mexican-style fast food–E.coli O26; flour–E.coli O121), the Inspector General expressed concern over the FDA recall process and criticized the agency for not having  better defined timeframes. In response to that report, FDA implemented the SCORE (Strategic Coordinated Outbreak Response and Evaluation) team, which guides concrete action plans for measures that the agency must take in the areas of recalls, for example. The team consists of decision makers from key operations and enforcement offices with a goal of expediting the evaluation of compliance and enforcement options. Since April, SCORE has addressed flour contaminated with peanut protein, facilities contaminated with Listeria, Salmonella in pistachios, and baby food that was not manufactured in compliance with infant formula regulations.
  • Antimicrobial resistance. The issue is “getting attention at the highest levels of government,” said Ostroff, adding that the best way to address antimicrobial resistance is to not have to treat it in the first place—and to do this is through reducing the incidence foodborne illness. The agency is moving forward in several areas here, including addressing non-judicial use of food animals and veterinary settings; enhancing NARMS data and isolate collection; and collecting data on antimicrobial sales by species.
Attendees listen to Stephen Ostroff, M.D., deputy commissioner for foods and veterinary medicine at FDA, give the keynote presentation at the 2016 Food Safety Consortium.
Attendees listen to Stephen Ostroff, M.D., deputy commissioner for foods and veterinary medicine at FDA, give the keynote presentation at the 2016 Food Safety Consortium.

During the Town Hall part of the presentation, Ostroff was asked, with the finalization of the FSMA rules, are they cast in stone? His answer: Not necessarily. “It took five years to get in place…because we did it in a very systematic way with a lot of stakeholder input. When you put together rules that are this complicated, there’s no guarantee that you got everything right,” he said. “[We] have to recognize that sometimes some of the flaws don’t become apparent into you implement them. You always have to be of the mindset that if everything didn’t work out exactly the way things were anticipated…we always have to be open to the fact that as we move forward and implement the rules, we might have to make course corrections.”

STOP Foodborne Illness

STOP Shines Spotlight on Commitment to Fight for Safe Food

By Food Safety Tech Staff
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STOP Foodborne Illness

Last night STOP Foodborne Illness recognized food safety heroes for their dedication to food safety. The fundraiser was held during the 2016 Food Safety Consortium.

Jeff Almer, STOP Foodborne Illness
Jeff Almer received the Food Safety Hero award for his work in bringing attention to the Salmonella outbreak involving Peanut Corporation of America. The illness took the life of Almer’s mother. Almer received the award from Gina Kramer, executive director of Savour Food Safety International.
LGMA, STOP Foodborne Illness
Dan Sutton (left) and Scott Horsfall (right) accepted the Food Safety Training Award on behalf of California Leafy Green Marketing Association from Deirdre Schlunegger (middle), CEO of STOP Foodborne Illness.
Tauxe, STOP Foodborne Illness
Robert Tauxe, M.D., MPH, deputy director of the CDC’s Division of Foodborne, Waterborne and Environmental Diseases at the National Center for Emerging and Zoonotic Infectious Diseases received the Advancing Science for Food Safety Award.
Recall

Possible Adulteration, About 2 Million Pounds of RTE Chicken Recalled

By Food Safety Tech Staff
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Recall

National Steak and Poultry has recalled about 1,976,089 pounds of ready-to-eat chicken products over concerns of bacterial pathogen survival in its products. According to FSIS, the product was adulterated due to “possible undercooking”. The expanded recall (the original recall included more than 17,000 pounds of product) was a result of a food service customer compliant  to an establishment on November 28 that a product appeared to be undercooked. The products of concern were produced from August 20 through November 30, 2016.

FSIS has provided a complete list of the expanded recall products on its website. There have been no reports of adverse events due to consumption of the products, but consumers are being urged to discard or return the items.

Clemson, Center for Produce Safety

Research to Prevent Heat-Resistant Salmonella in Poultry Litter

By Food Safety Tech Staff
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Clemson, Center for Produce Safety

Recent research funded by the Center for Produce Safety (CPS) found that Salmonella cells may be more heat resistant during poultry litter heat treatments. This can be an issue because heat treatment is used to reduce or eliminate pathogenic microorganisms. A two-year project conducted at Clemson University is examining how moisture and heat treatment can work together to inactivate Salmonella in chicken litter. Researchers are about half way through the project and are working with two large poultry litter processors to validate heat-treatment processes in an industrial setting, and are using Salmonella surrogate and indicator microorganisms that the researchers identified in the study.

The goal of the study, according to investigator Xiuping Jiang, Ph.D. of Clemson University, is to help create guidelines that include residence time, temperature and moisture levels, and tools to assist the fertilizer industry in providing more microbiological safety in their products.

More details about the study, “Validating a physically heat-treated process for poultry litter in industry settings using the avirulent Salmonella surrogates or indicator microorganisms”, are available on the CPS website.