Stephen Ostroff, M.D. will keynote at the 2017 Food Safety Consortium on November 29 | Learn moreHow will the FDA gauge how well the food industry understands FSMA? This question was posed to agency Deputy Commissioner for Foods and Veterinary Medicine Stephen Ostroff, M.D. at the 2016 Food Safety Consortium.
While it will be important for FDA to have measures that it can use in assessing compliance, the process will take time. Watch Ostroff’s response in the following video.
Today FDA updated its FSMA training strategy to reflect the progress made during 2016. The program, which targets farmers, small food processors and small produce merchant wholesalers, includes the following updates:
Cooperative agreement for small and mid-size businesses involved in local food production awarded to the National Farmers Union Foundation
Cooperative agreement for preparing food producers in Native American tribes awarded to the University of Arkansas in Fayetteville
Federal grants awarded for establishing regional centers to facilitate training under FDA’s partnership with USA’s National Institute of Food and Agriculture
Stephen Ostroff, M.D. will keynote at the 2017 Food Safety Consortium on November 29 | Learn moreEarlier this month Stephen Ostroff, M.D., deputy commissioner for foods and veterinary medicine at FDA, told attendees at the 2016 Food Safety Consortium about the agency’s commitment to a proactive food safety system. He also discussed FDA’s stance on criminal liability and took questions from the audience, one of which was: Now that the FSMA rules are final, are they cast in stone? Does FDA have any flexibility in making changes. Listen to Ostroff’s answer in the following video.
The increasing complexity of the global food chain has also increased the complexity of traceability of ingredients. However, FSMA has made this task a critical part of the seed to fork process. More vigilance and awareness of the supply chain is an essential part of protecting consumers and the company brand, and plays in an important role in the event of a recall. In a Q&A with Food Safety Tech Dean Wiltse, CEO of FoodLogiQ, explains the issues the food industry is experience in this area and why transparency in the supply chain will become the new normal.
Food Safety Tech: What are the biggest supply chain challenges you see industry facing today?
Dean Wiltse: The biggest challenge we see in the food supply chain is getting beyond the “one-up and one-back” approach to supply chain management to achieve real transparency in the supply chain. Now I think more than ever consumers want to know more information about their food and 2017 is going to be the year of transparency. A year of getting beyond one-up and one-back, and beyond the four walls of the food manufacturing facility to really dig down and understand what is going on two, three, four, or five levels down the supply chain, from a safety and risk mitigation standpoint.
I also think food companies will continue to be challenged by the ripple effect of increased recalls: Sunflower seeds, flour, powdered milk. Many food companies were rocked with these recalls in 2016. We expect these recalls to continue in scale and frequency going into 2017.
Another challenge is in the area of quality incidents—and the monitoring of those quality incidents. Oftentimes these quality issues go unchecked and it’s damaging to the quality of your food—and of course your brand—as well as damaging to the bottom line.
FST: How should companies monitor and ensure that they are getting high quality product from suppliers?
Wiltse: It sounds simple, but it all starts with being aware of exactly where you are experiencing quality issues across your supply chain. At FoodLogiQ, we pull all of the quality and incident data together in our dashboard to enable food companies to know exactly which suppliers you are having quality issues with and which ones you aren’t.
FoodLogiQ dashboards enable users to monitor quality issues in the supply chain and document incidents. (Click above images to enlarge the dashboards)
Tracking and documenting these incidents—followed by the corrective actions—is critical. It is also important that all of the requirements and expectations are communicated openly; it makes the food supply chain safer by opening up transparency.
Customers can also use our technology to aggregate the quality and safety data into a star rating for their suppliers. Defining what is important to you from a quality and safety standpoint and aggregate that data in the software, and then assign a star rating for your suppliers. You can then use this star rating to formulate your preferred and approved supplier list.
FST: Where are the biggest disconnects in the supply chain? And how can companies rectify this?
Wiltse: Back to what the consumer is demanding: More information about their food, where it came from and what exactly is in it. Leading food brands want to provide this level of transparency to their consumers, but many are struggling with delivering this information in an authentic, real-time fashion.
Today there’s technology that can deliver it to them. In order to get more granular and provide more detailed information through the supply chain, there’s a cost associated with that, even down to the labeling at the grower for traceability. Many in the industry view this as an additional cost, but the leaders see this as a strategic investment and realize there is significant ROI in supply chain transparency.
FST: What are the most serious concerns surrounding FSMA and the supply chain?
Wiltse: Clearly the majority of the industry has been preparing for FSMA for several years now, getting their processes in place, if they weren’t already. Where we see a significant opportunity for companies to be proactive is in centralizing their required records, safety plans, and other essential processes into one platform for their entire supply chain.
We see many food companies who may have the required documentation and corrective actions in place, but they are scattered or siloed throughout the organization, and not centralized and easily accessible when the FDA calls on you to provide that information.
Another challenge is certainly top of mind is foreign supplier verification. The wave of required verification for foreign suppliers will be significant for many companies so they must be vigilant and start that process now or risk a significant disruption to their business.
FDA also announced its fiscal year 2017 fee rate for accreditation bodies that are applying to be recognized by the third-party certification program. The fee will remain in effect through September 30, 2017.
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.”
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.”
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
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.
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, 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.
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