In the final article in Food Safety Tech’s Q&A series on food safety culture, Lone Jespersen, director of food safety at Maple Leaf Foods, and Brian Bedard, executive director of the GMA Science and Education Foundation sound off on the development of food safety culture this year.
Food Safety Tech: Where are we headed in the food safety culture landscape in 2016?
The GMA Science Forum takes place April 18–21, 2016 in Washington, DC | LEARN MORELone Jespersen: I think we’re going down a path of standardizing or at least agreeing on a set of definitions for food safety culture. Some of this will come out of the GFSI technical working group on food safety culture. That will lead us to better guidelines for what the different components of food safety culture are. That’s going to be strongly science based and collectively agreed upon. I think we’ll see a lot of that work done in 2016.
I think we’re also going to see a greater focus on connecting food safety culture to organizational culture. Many organizations are looking at integrating food safety and quality assessments into their organizational culture assessments and I think for larger organizations this makes sense.
Lone Jespersen of Maple Leaf Foods debates food safety culture at the 2015 Food Safety Consortium.
I hope we’ll get closer to having compared measurement systems and be able to publish work around that so we don’t fall into a trap of a fragmented and independent approach, but rather building on each other as we work [together] and have a common definition.
Brian Bedard: The measurement tools and the gap analysis for which these tools are being developed needs to be done. In terms of operationalizing and actually getting food safety embedded in companies, I would envision a roadmap that looks at a four-tiered framework of who the targets are for changing behaviors. That would be focused around senior leaders in an organization, mid-level managers, supervisors in operations, and at the fourth level, the operators on the plant floor. At GMA’s Science & Education Foundation, we have a group of companies investing in this to roll out a portfolio of training programs. We’re trying to consolidate them under the umbrella of food safety culture and dealing with the full spectrum, from entry level and plant operators through to senior leadership.
A group of industry stakeholders in sustainable agriculture, environmental, beekeeper and public interest groups are call for reform at the USDA. In a letter sent to Doug Banner, scientific integrity officer at USDA yesterday, the coalition of more than 50 organizations ask for reforms to the agency’s scientific integrity policy. “The agency must prohibit suppression and alteration of scientific findings, employ clear and enforceable procedures for conducting loss of scientific integrity investigations, assure transparency and consistency in the administration of policies, adopt strong protections for scientists who file misconduct complaints, and participate in misconduct investigations when scientists and their work face interference. These actions are needed to ensure that USDA scientists can properly do their jobs.”
A recent article in The Washington Post details the story of USDA Entomologist and whistleblower Jonathan Lundgren, who has attributed the rapid decline in honeybees to the overuse of pesticides and the lack of crop diversity. Lundgren filed a whistleblower suit last fall, claiming he was suspended to prevent his research on the harmful effects of pesticides on pollinators.
According to a news release from Friends of the Earth: “An internal scientific integrity review panel at the USDA recently rejected the complaint of scientific suppression by Lundgren, claiming that agency had not violated its scientific integrity policies. In February 2016, USDA Inspector General Phyllis Fong said the USDA will open a broad investigation into the issue of scientific censorship, but did not specify whether the investigation would be made publicly available.”
The USDA, which outlines its scientific integrity policy on its website, has not released a public statement addressing the coalition’s letter.
FDA has announced that FDA Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor is leaving the agency on June 1, 2016. Dr. Stephen Ostroff (most recently served as acting commissioner) will become the second Deputy Commissioner for Foods and Veterinary Medicine.
According to an FDA release:
Mr. Taylor joined FDA in July 2009 and was named to this position in 2010. Since that time, he has led the implementation of the FDA Food Safety Modernization Act, the most sweeping food safety reform in more than 70 years, and guided nutrition-related initiatives to reduce the risk factors for chronic disease and other adverse diet-related outcomes. He has overseen the move to eliminate the use of certain antibiotics that can contribute to the development of antimicrobial-resistant bacteria. Understanding the importance of dialogue, partnership, and active stakeholder engagement in effecting change, Mr. Taylor has sought to ensure everyone had a place at the table in designing rules and taking actions to protect Americans and contribute to a safer, more wholesome food supply.
A nationally recognized food safety expert, Mr. Taylor has served in numerous high-level positions at FDA, as a research professor in the academic community, and on several National Academy of Sciences expert committees studying food-related issues. He also served as administrator of USDA’s Food Safety and Inspection Service (FSIS) and acting under secretary for food safety at USDA, where he spearheaded public health-oriented reform of FSIS, guided the development of new safety requirements for meat and poultry products, and addressed the hazard associated with E. coli O157:H7 in beef products.
Mr. Taylor plans to continue working on in the food safety arena, focusing on those settings where people lack regular access to sufficient, nutritious and safe food.
Prior to serving as acting FDA commissioner, Dr. Ostroff was named the agency’s chief scientist in 2014, and was responsible for leading and coordinating FDA’s cross-cutting scientific and public health efforts. Dr. Ostroff joined FDA in 2013 as chief medical officer in the Center for Food Safety and Applied Nutrition and senior public health advisor to Mr. Taylor. Prior to that, he served as deputy director of the National Center for Infectious Diseases at the Centers for Disease Control and Prevention (CDC), and as Director of the Bureau of Epidemiology and Acting Physician General at the Pennsylvania Department of Health. He is a graduate of the University of Pennsylvania of Medicine and completed residencies in internal medicine at the University of Colorado Health Sciences Center and in preventive medicine at CDC.
Dr. Ostroff’s expertise in public health and knowledge of food safety, nutrition and veterinary medicine programs will ensure a smooth and seamless transition. Between now and June 1, Mr. Taylor and Dr. Ostroff will work closely together, with FDA Commissioner Califf’s strong support, to manage a transition that sustains the program’s momentum on the many challenges and opportunities that lie ahead for FDA.
Food safety culture is yet another example of the current and future state in food safety: The movement toward being proactive versus reactive. There are still many questions surrounding how companies should be measuring behavior and a lot of companies don’t know where to start. Lone Jesperson, director of food safety at Maple Leaf Foods, provides some guidance in part 3 of Food Safety Tech’s series on food safety culture.
Food Safety Tech: What are the most important behaviors that organizations should be measuring?
Lone Jespersen, Maple Leaf Foods
Lone Jespersen: I think we need to get the order right. You start by figuring out the metrics, which should drive behavior, not the other way around. If you’re not clear on how you’re going to measure success, then how are you going to know that the behaviors you’ve identified will make a difference to the safety of your products or food?
Ultimately you want to be in a situation where people are looking out for food safety so that if something goes wrong, it’s constructively brought forward and fixed. Predictive and preventive measures are defined and implemented as needed. When talking about food safety—the metrics and behaviors—these depend on the organization’s state of maturity. [For example,] in an organization with a relatively low level of maturity that doubts whether food safety [culture] is something that is going to help the business, they’re mostly checking boxes and conducting food safety tasks because regulators are saying they have to.
So if you’re in that state of doubt, I would look at measuring something like: Are you completing your food safety training? Does that manager complete food safety communication on a regular basis? Has the plant done its risk assessment in a standardized way? Do they have tools and infrastructures in place to meet food safety requirements? That can spill over into a measurement that your plant manager actively enforces the training schedule for food safety. It [becomes] a behavior you can define outright and measure the plant manager on.
The GMA Science Forum takes place April 18–21, 2016 in Washington, DC | LEARN MOREOn the other end of the maturity model, there’s the relatively high level of sophistication and maturity for food safety. For example, a CEO completes a food safety workout session in which he or she sits down and looks at what the plant needs to do to improve food safety, and the decisions are made on the spot. When you’re in that level of maturity, you’re improving your food safety costs, because you have better control of your food safety program and you’ll get more uptime, less downtime, and make product that goes out safely.
We’ve had some great discussions around food safety culture metrics. But I think we’re a little misguided, because we’re not measuring food safety culture, we’re measuring the organization’s performance, and food safety culture is an enabler that is tracked to performance. So if you have a weak culture, it’s reasonable to assume you’ll have higher costs and a higher level of incidents, and less competent individuals. There are some characteristics you can put around the performance of food safety if you have a weak culture. There’s lots of research that shows the connection between organizational effectiveness and organizational culture. I have yet to find a counterargument that says it should be different for food safety culture.
It’s not a food safety culture metric that you need, it’s a performance effectiveness measure. We are looking at culture because we want to improve our performance—for consumer and business protection.
On Friday FDA released its 2015 Annual Report to Congress on the Use of Mandatory Recall Authority and there was not much news to report. According to the agency: “In FY 2015, FDA had no mandatory recall activity to report under section 423 of the FD&C Act. As a result, FDA did not issue any public health advisories as described in section 206(f) of FSMA.”
This is the third report of its kind since FSMA was enacted. It is worthy to not that it only deals with recalls themselves, not other agency communication efforts such as public health advisories, which include consumer advisories, warning letters and reports of outbreak investigations.
In light of the FSMA Produce Safety rule, FDA is asking industry for feedback on the use of raw manure (which has been seen as an effective method to enrich soil quality) and its potential to contain disease-causing bacteria. In a Federal Register notice just released, FDA is requesting “scientific data, information, and comments that would assist the agency in its plan to develop a risk assessment for produce grown in fields or other growing areas amended with untreated biological soil amendments of animal origin (including raw manure).” The risk assessment will evaluate and quantify any risk of human illness related to consuming produce grown in fields or other areas that contain such untreated soil for pathogens including E. coli O157:H7 and Salmonella.
The agency is asking industry for more information about how farms use raw manure, along with strategies that should be taken into account in order to reduce the health risk to the public.
The Federal Register notice will be published March 4. There is a 60-day period to submit comments and scientific data.
Most industries face issues with breaking down silos and promoting cross-functional collaboration. For the next class of leaders to be well equipped to promote and practice a strong food safety culture, more work needs to be done on alignment within organizations and across industry. In part II of Food Safety Tech’s series on food safety culture, Brian Bedard, executive director of the GMA Science and Education Foundation and Lone Jespersen weigh in on leadership.
Food Safety Tech: Food Safety Culture requires strong professional leaders. How can industry work together to develop the leadership that is needed?
The GMA Science Forum takes place April 18–21, 2016 in Washington, DC | LEARN MORELone Jespersen: We start by acknowledging that we have an abundance of strong leaders in the food industry. We don’t need to build from the ground up or something new. We need to look at what makes [these leaders] strong. Why are some leaders more successful than others? Identify the companies that have strong food safety leaders that are not within food safety—those that come from finance, HR, procurement, and the CEO—and formally acknowledge their technical and leadership competencies.
I’m aware of three organizations that are actively looking at what constitutes a food safety professional and its competencies—IFPTI (International Food Protection Training Institute) in the United States, Safe Food Canada, and the International Union of Food Science and Technology. Alignment between the work conducted by each of these organizations is important to shorten the time between development and business impact. It’s really important to get this alignment. The more we keep working in small subgroups while not comparing notes and agreeing on those competencies, the more we’re going to see the cost of developing leaders going up. And we’ll have fewer strong leaders, because it will be hard for individuals to move on in their career if it is not clear what it means to be a competent, strong food safety leader.
There’s a very large group of food safety leaders, the ‘Malcolms-in-the-Middle’ who are excellent leaders and are one or two steps down from the head of food safety in an organization. Sometimes we forget that we have strong leaders at this level, and they have a much stronger handle on food safety culture because they’re the ones who have to make sure programs work for frontline associates, supervisors, and managers. Letting that level become more visible to what their competencies are or should be and making sure that they contribute and are heard in the conversations [is important].
Brian Bedard: We need to collaborate and get some alignment around what we think leaders need. Unfortunately, this is creating a competitive space among service providers and training entities that can work with leaders.
There are a couple of fundamental principles that need to be addressed:
The leaders at the top need to recognize and drive it down through their entire system so that everyone is responsible in terms of their annual work and development plans, including metrics and the deliverables in their annual evaluations
The ‘Malcolms-in-the-Middle’ who, in most cases, manage the budget. It’s critical to get them on board to ensure that, when making investments, they’re spending money on driving food safety culture throughout an organization
Several specific opportunities now exist to promote food safety culture leadership, including the Food Safety Leadership Workshop being offered by the GMA Science and Education Foundation at the upcoming GMA Science Forum (April 18, Washington, DC).
In an 89-4 vote by the U.S. Senate, Robert Califf, M.D., was confirmed as the next commissioner of FDA last week. The accomplished cardiologist and researcher will take on the task of implementing FSMA, along with responsibilities in overseeing medical device and pharmaceutical regulations, and tobacco products.
“I commend the Senate for their bipartisan vote today and am pleased that President Obama’s nominee, Dr. Robert Califf, will become the commissioner of the Food and Drug Administration, said Sylvia M. Burwell, HHS secretary, in a statement. “I look forward to working with Dr. Califf to ensure the FDA can carry out every aspect of its critical mission; from ensuring the safety and effectiveness of the medical products we use, to protecting the nation’s food supply and implementing its oversight of tobacco products, to furthering our efforts to combat opioid abuse.”
From measurement tools to a shift in mindset and leadership, a recent debate at the Food Safety Consortium brought to light the varying levels of opinion and understanding about food safety culture. In a four-part series with Food Safety Tech, Brian Bedard, executive director of the GMA Science and Education Foundation and Lone Jespersen, director of food safety at Maple Leaf Foods continue the conversation about food safety culture and where it’s headed in 2016.
Food Safety Tech: What is the most controversial aspect to the concept of Food Safety Culture?
Lone Jespersen debates food safety culture at the Food Safety Consortium in November.
Lone Jespersen: I don’t think there are a lot of controversial aspects. I think the debate in Chicago [at the Food Safety Consortium] showed exactly that—companies understand the importance of food safety culture. The challenges that we collectively face lies in what food safety culture is and how we can best measure improvements within our organization to sustain a strong and effective food safety culture. That, by definition, requires that we know what food safety culture is and what we are going to measure. That is where the lack of clarity, understanding, and alignment is.
Over the last few months, I’ve done a lot of comparisons between the measurement tools, and they’re actually not terribly different, but as usual, we get confused by words. As long as we have a clear understanding of how tools are different and what they actually measure, it will be possible for each of us to select the best method for our organization. It’s more confusion than controversy. If we speak of controversy, I think it is with manufacturers and processors who are increasingly worried about what FDA is going to do when they talk about the food safety culture—will investigators come and look for food safety culture without a clear understanding of what it is? Again, it requires that we have a common understanding, which we don’t have today.
Brian Bedard of the GMA SEF at the Food Safety Consortium
Brian Bedard: I agree. It’s not really controversy; it’s more of confusion and misunderstanding. We’re seeing some alignment and a better understanding that food safety culture is not something totally different and out in left field; it’s a new way of looking at food safety that is all-encompassing and gets around what was happening in the past, which was an ad-hoc, disjointed approach to dealing with food safety issues. It gives companies a more refined process to drive food safety that everyone can understand, from senior managers right on down.
Regulators around the world are looking at food safety culture as one way to help them do their work better. Our concern is that food safety culture shouldn’t become a regulatory tool per se but should be awareness and [an] appreciation that food safety culture at a company can help regulators better understand the risks they are supposed to be evaluating in a preventive manner.
The GMA Science Forum takes place April 18–21, 2016 in Washington, DC | LEARN MOREJespersen: It’s also about looking at food safety culture and the discussion today, which largely takes place in the forum of food scientists, food safety leaders, heads of food safety at large organizations—in other words, between individuals who are educated and experienced food safety professionals. Their experience is in developing microbiological environmental testing programs, full-scale food safety management systems that go across manufacturing facilities—very complex and technical issues, all of which couldn’t be more different than that required of a professional within an organizational where it’s about behaviors and consequences. The same goes for investigators and auditors [and their roles]—they’re good at assessing written systems, etc. What about behavioural observations and assessments? This stakeholder assessment hasn’t been a part of the debate, and we need to bring it in.
Increased media attention and consumer awareness of verifying ingredients, detecting allergens and effectively tracing the source of outbreaks has placed much higher scrutiny on food processors and manufacturers. With the anticipated FSMA final rule on intention adulteration (Focused Mitigation Strategies to Product Food Against Intentional Adulteration) expected in late spring, having the ability to effectively detect and address product contamination and adulteration will be of significant importance to manufacturers. In preparation for the upcoming Food Labs Conference March 7–8, Food Safety Tech sat down with Craig Schwandt, Ph.D., director of industrial services at McCrone Associates, to learn how contamination is currently affecting food companies and what they should be doing to protect their products and ensure consumer safety.
Craig Schwandt will be presenting “Contaminant Particle Identification: Establishing Provenance and Complying with FSMA” at this year’s Food Labs Conference | March 7–8 | LEARN MOREFood Safety Tech: What are the big issues facing the food industry related to product contamination?
Craig Schwandt: I think the biggest issue facing the food safety industry is realizing that FSMA, in its final ruling, comes with requirements to ensure food safety from farm to table. In the past, many [ingredients] were GRAs, or generally recognized as safe, so when there was a contaminant, [food companies] had a lot of liberty in disposing of the batch and weren’t too concerned about where it came from.
FSMA is going to require that [food companies] keep records of what contaminants are found, how they address it and whether it’s a recurring problem, and [that they] have a procedure in place to track back and [conduct] forensic analysis. In the analytical services industry we call it investigational analysis, which is a description of what actually takes place for ascertaining what the contaminant is and how it got there. That information is provided to clients so they can track back in their production process—all the way to the raw materials and then ascertain where the contaminants came from in that production chain.
The big challenge will be in recognizing that they have to start keeping records and then actually doing the investigation to determine what contaminants are there and determine where they’re coming in.
Craig Schwandt, Ph.D., McCrone Associates
FST: Are companies taking the right steps to detect and identify contaminants in food?
Schwandt: Some of them do and some don’t. At last year’s Institute of Food Technologist’s conference in Chicago, there was a session on FSMA in which there were representatives from FDA, the Grocery Manufacturers Association and a major food company. I was a little bit shocked by the food company’s position. They felt they didn’t need to take all of the steps required by FSMA because they dealt directly with producers from all over the world. They felt removing intermediaries from their supply chain sufficiently protected their products from adulteration. This seems to be oversimplifying the production and supply chain process. Even though they may directly deal with farmers, there’s still opportunity from the time food stuff is harvested to being dried, placed in containers, and shipped from overseas to the U.S.—there are several steps where unintentional contaminants can arise. So to say they didn’t need to look at the potential for contamination because they dealt directly [with farmers] is a bit oversimplified. I think this perspective typifies some of the industry’s viewpoint at the moment.
The Foreign Supplier Verification Program specifically addresses this concern. Even companies that deal directly with producers and supplies in the country of the product’s origin will be required to demonstrate that they tested it and verified it as uncontaminated.
The understanding and recognition by suppliers of these new regulations is the biggest issue facing the food industry right now—especially now that the final rulings have been issued and we’re in the grace period before compliance with the regulation is required.
FST: What technologies are helping in the effort to fight product adulteration, especially as it relates to FSMA compliance?
Schwandt: Handheld instrumentation is making headway at identifying, at a gross scale, screening capabilities—handheld x-ray fluorescence instrumentation and handheld infrared spectroscopy, to identify things at the bulk level. Mass spectrometry methods and chromatography are exceptional at their ability to do really fast general screening for chemical adulterants. I think many of the food laboratories and food companies have in-house laboratories and screen in that general way.
In terms of some of the solid phase contaminants, I think there’s a lack of in-house capability at the moment where one can use simpler [methods] like optical microscopy and another microscopy-based methods to identify the physical solid phase contaminants.
A good example is the use of magnetometers. Many companies use large-scale process line magnetometers to highlight the presence of metal pieces in their product. A magnetometer tells you that there are metal contaminants in your product, it does not provide a specific alloy identification. Whether one needs to go further to use additional methods and actually ascertain the composition of the alloy, is the question. That’s a new requirement—to identify what it is and then to try and assess where in the process it may have occurred. Using a microscopy-based method is advantageous because metal pieces are easily isolated and identified. Once food industry clients have an idea of what the alloy is, they can compare it to the metal alloys that make up their machinery along the way, whether it’s packaging or sorting machinery, [and] essentially establish where the particles enter into the food process.
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