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:
Establishing a zero-tolerance policy for raw beef products that contain shiga-toxin producing E. coli: O26, O103, O45, O111, O121 and O145.
Labeling mechanically tenderized meat. The blades or needles used to tenderize meat an introduce pathogens into the meat.
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.
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.
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.
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.
Training plays a crucial role in the FSMA Preventive Controls rule. As online learning becomes a more integral part of employee learning, companies may want to reexamine the methods they use to boost more effective outcomes. And for companies that currently use face-to-face training, investing in a virtual approach could encourage a more proactive employee learning experience.
“Industry research tells us that company leaders want training that is relevant, in which employees can apply skills right away.” – Kathryn Birmingham, ImEpik
“Under the [Preventive Controls for] Human Food rule we have legal roles that didn’t exist before—we must create smarter career pathways for these new positions and responsibilities, such as the Qualified Individual under the PCQI, the Preventive Controls Qualified Individual, and the auditor,” says Kathryn Birmingham, vice president, research and development at ImEpik. “The compliance required for these new positions is a great opportunity to use innovative and scalable training models. This becomes even more important for ROI (return on investment) in training, when turnover is likely or when companies want to attract new talent into the food safety industry.”
In a Q&A with Food Safety Tech, Birmingham explains how companies can navigate some of the additional training requirements under FSMA and how interactive online learning may offer both employees and companies more successful results.
Food Safety Tech:What employee training challenges do today’s food companies face?
Kathryn Birmingham: As an educator, business owner and researcher who has designed certification and degree programs for workforce training in several industries, I see [that] the food manufacturing industry must move from lifetime experience training to training standards. For the first time, the evidence of QI training and PCQI credential are owned by the person as they move from company to company.
Food companies need a cost-effective training system that can assess knowledge, skills and competency standards. Industry research tells us that company leaders want training that is relevant, in which employees can apply skills right away. They want to be able to test the knowledge of persons in these new roles who are accountable for regulatory compliance. Thus they expect valid assessments in their certification training.
The demand is for smarter pathways to reach these new legal roles in the legislation for the QI and PCQI. Assisting in this area, we need to remember that food manufacturing companies view their number one job as making food, not completing paperwork or digital documentation, so when it comes to FSMA we have to come up with relevant training that can be applied right away.
FST: In what areas do you think companies are unprepared for FSMA implementation and compliance?
Birmingham: Companies seem to be least confident in terms of training in a few areas: For the legal role of the PCQI, they seem to be least confident about the record keeping requirements and foreign supplier verification areas.
For the role of the QI, standardized training doesn’t exist, but we know from the PCQI training that if the QI is required to implement the food safety plan under the PCQI, then QIs must understand components of the food safety plan and the hazard analysis. So it follows that the QI must also understand some scientific and regulatory factors related to the preventive controls along with the new language that must be used in the food safety plan and documentation.
FST: What tools or technologies should companies leverage?
Birmingham: Research and successful practice in workforce training tells us a few things. In order to speed learning and verify the trainee’s learning, knowledge and competencies, we recommend instructional methods that are immediately relevant, engaging and motivating. Effective training for food safety regulatory compliance helps the learner with stronger critical thinking for decision-making and encourages the learner to apply the skills right away. Modular instruction allows time for practice and reflection while increasing the odds of retention of the material. Relevant work simulations can teach technical and scientific knowledge as well as communication skills.
We recommend online training that demonstrates proficiency and mastery rather than passive learning. The learner must engage and practice what they’re learning, show an understanding, practice critical thinking, and pass valid assessment exercises.
ImEpik’s survey aimed to understand expectations as well as effectiveness of online training. Infographic excerpt courtesy of ImEpik.
FST: Do you think a lot of passive learning is happening in the food industry?
Birmingham: [Birmingham cites a food safety online training survey conducted by ImEpik earlier this year; see Table I.] Survey responses from a sample of 140 companies are telling us that they’re not satisfied with lack of engagement in training offerings. Those overseeing training would like to see more valid assessments. In terms of passive learning, they don’t want to click through voice-over narration for training or have face-to-face training that is lecture style without a lot of engagement. They want to understand the learning outcomes and what they should be getting out of the curriculum as they move through the training.
Preference for Specific Online Learning Attributes
I Dislike It
I Can Tolerate
I Expect It
I Like It
Multi-languages
—
10%
Valid Assessments
—
—
91%
Research-based Instructional Methodologies
—
—
79%
Learner Engagement
—
—
77%
Interactive Activities
—
—
73%
Certificate of Completion
—
—
65%
Supplementary Manual
—
—
55%
Animation
—
—
35%
Learning Analytics
—
—
55%
Table I. Results from ImEpik survey about food safety online training. While animation and learning analytics are not as expected in online learning, these attributes are an important part of simulating the work experience in order to apply new knowledge, test specific content areas for clarity and assist the learner in remediation as needed. Data courtesy of ImEpik.
In the 2015 survey, 73% said they expect interactive activity in training while 91% expect valid assessment. People are looking for feedback as they progress through training. In the end they want to have the ability to prove what they know and can do.
With the emphasis now on FSMA, for companies to develop their entire food safety team, we need to rethink training and remember that it is possible to look at other industries and see what they’ve done with these career pathways for new roles that have been legislated. We can compare online training that is accessible anywhere and agile enough to train for new concepts quickly. Science and GMPs change. This is where a tool like online learning—not only full-course certification courses but also micro-learning modules—can really help the industry. And in the long run, it could be a better return on investment than face-to-face and long-term experiential learning.
The U.S. Senate Committee on Agriculture, Nutrition, and Forestry has come to an agreement on the first-of-its-kind nationwide mandatory labeling of food products that contain genetically modified organisms (GMOs). Although the deal requires labeling on far more products than those required under the Vermont GMO labeling law (which goes into effect July 1), the way in which disclosure of genetically engineered ingredients is revealed on food products is not as straightforward as it seems. Under the bill, disclosure methods of GMOs on labeling includes on the actual packaging; an electronic/digital link that a consumer can scan with a smartphone to retrieve more information online; or a phone number in which a consumer can call to get more information. Thus, companies are not required to include all of the information on the product label.
The Center for Food Safety estimates that 75% of processed foods contain genetically engineered ingredients.The Senate Agriculture Committee praises the bill as a “win for consumers”, but there are industry folks who disagree. “While we are pleased this proposal will finally create a national, mandatory GMO disclosure system, protects organic labels, and will cover more food than Vermont’s groundbreaking GMO labeling law, we are disappointed that the proposal will require many consumers to rely on smart-phones to learn basic information about their food.,” said Gary Hirshberg, chairman of Stonyfield Farm and advocacy group Just Label It in a release.
It hides in the crevices. Once it gets onto equipment, it can linger for years. It’s biofilm, a formation of bacteria that adheres to surfaces and can be quite difficult to eradicate. A host of microorganisms, including Listeria and Salmonella, are linked to biofilm contamination. The following are insights gathered from Dominique Blackman, general manager at Realzyme, LLC and Jeff Mitchell, vice president of food safety at Chemstar during Food Safety Tech’s recent Listeria Detection & Control Workshop.
Biofilm Facts
Protected by multiple layers of polysaccharides
Acts as binding site for antimicrobials as well as a diffusion site, protecting bacteria within
Mechanisms of dispersal
Active: Releases cells based on environmental changes
Passive: Occurs as a result of shear or agitation (i.e., when doing deep cleans or moving equipment)
Hot spots
Transfer points in facility
Product contact points on equipment
Drains
Seams in walls/floor-wall junctures
Door seals
Cart wheels
Overhead vents and pipes
Causes a variety of problems within food manufacturing facilities, including:
Product contamination = Economic loss (i.e., as a result of recalls)
Reduced product shelf life (i.e., result of recurring contamination)
Reduced productivity, especially when equipment isn’t cleaned properly
Bacterial resistance to disinfection
Surface corrosion (the longer biofilm is in one place, the more time it has to damage equipment)
Successful removal requires complete penetration of extracellular polymeric substance without inactivating any sanitizer
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.
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.
One year ago, the industry was speculating about the details of the final FSMA rules, but was very much taking a “wait-and-see” approach. With all seven rules finalized, companies are now preparing for compliance. Beyond taking the steps to ensure that companies understand their responsibilities pertaining to each rule, there has been continual concern over a lack of C-suite awareness—both related to FSMA and knowing what is really happening at the ground level. “I think there’s been a culture shift with food safety professionals having more visibility to the leadership team and to the C-suite,” said Christina Romas, senior vice president at Repositrak, during a recent interview with Food Safety Tech.
When asked whether she thought the C-suite adequately understands FSMA, Romas succinctly replied, “no”. Watch the rest of the video to hear what Romas had to say about FSMA compliance challenges and which rule is getting the most attention from industry thus far.
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.
The ubiquitous nature of Listeria has made it a difficult pathogen to detect, control, and find its root cause. Led by Gina Kramer, executive director of Savour Food Safety International, attendees of last week’s Listeria Detection & Control Workshop learned everything from the cost of Listeria ($1.4 million per case and $2.3–$22 billion in the United States annually) to the challenges of breaking down biofilms to the steps a company should be taking to do sanitation right and get rid of resident Listeria in their facility. Here’s a snapshot of what experts said as they addressed industry’s obligation to ensure that their facilities are constantly monitored for contamination to ensure that safe product comes out of their plants.
People equate local and organic with safer, safer, safer. That’s not true, because pathogens are agnostic. – Gina Kramer, executive director, Savour Food Safety International
Whole genome-based outbreak detection allows us to detect more quickly, with greater precision in identifying source — John Besser, Ph.D., Deputy Chief, Enteric Diseases Laboratory Branch, CDC
What’s happening in your plants? What are you taking into your processing plant? What time of year is it coming in? What is your environment—is it more urban or rural? The presence of Listeria isn’t any greater in an urban or rural environment. You might find it in different places, but there isn’t a difference in incidence. – Janet Buffer, corporate food safety manager, The Kroger Co.
Biofilm erupts like a volcano. But once it has erupted, your volcano goes dormant. And for how long? Nobody knows. That’s the problem. The biofilm can release two days later, a week, or a month later. – Dominique Blackman, general manager, Realzyme
Listeria testing is the ugly duckling in preventive controls. Companies need to ask themselves whether the method they use is able to detect potential positives in the environment. – Ted Andrews, senior director, product marketing, Roka Bioscience
Sanitation is not one size fits all. You need to have specific controls in place that look at controlling Listeria not just for equipment but periodic infrastructure and equipment and routines. Validate that they work. Train employees so they properly execute. – Jeff Mitchell, vice president of food safety, Chemstar
You’ve identified Listeria in your facility. Now what? Review touch points: This includes the air, surfaces, transportation and packaging areas. – Troy Smith, CEO, Radiant Industrial Solutions, LLC
If you get everything mostly right, what are the odds that you’ll find a pathogen in end product testing? Getting the proper data point is a big deal. – Douglas Marshall, Ph.D., chief scientific officer, Eurofins
With less than a week under his belt as the new Deputy Commissioner for Foods and Veterinary Medicine, Stephen Ostroff, M.D., has made one of his first official statements about food safety. Calling the FSMA final rules a paradigm shift in prevention versus response, he emphasized the importance of the implementation stage on FDA Voice, the agency’s blog.
“The people of FDA, under the leadership of Michael R. Taylor, worked tirelessly to find the right intersection between science and policy; to develop innovative and practical solutions to complex challenges; and, to engage in open and meaningful discussions with the many communities within the diverse food supply system,” said Ostroff in the blog.
Although industry has “miles to go” during implementation, Ostroff emphasized the behind-the-scenes work that made FSMA happen—thanking specific members of Congress, consumer activists such as STOP Foodborne Illness, public policy organizations, national associations such as the Grocery Manufacturers Association, government organizations and global regulatory counterparts.
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