Today FDA published a draft guidance to help qualified facilities in complying with the FSMA Preventive Controls (PC) for Human and Animal Food rules. Businesses that are defined as qualified facilities are subject to modified requirements of the PC rules, which can be met by submitting a form to FDA confirming that the site is implementing PCs to address hazards related to its food or is in compliance with non-Federal food safety laws and regulations.
The draft guidance, “Qualified Facility Attestation Using From FDA 3942a (for Human Food) or Form FDA 3942b (for Animal Food)” discusses how to determine whether a business meets the “qualified facility” definition and how to submit the form that demonstrates this status.
The Federal Register is scheduled to publish the document on May 16, at which point the draft guidance will be available for public comment for 180 days.
A new industry survey is highlighting several issues facing food safety and quality assurance professionals, from employee retention to understanding the final FSMA rules. The 2016 Annual TraceGains Food Safety & Quality Assurance (FSQA) Professional Survey digs into the top priorities (FSMA compliance, audit readiness, supplier relationship management, etc.) of professionals and sheds light on some of the current challenges that companies are facing, especially in the area of compliance, FSMA readiness and supplier documentation.
“We’re seeing a recipe for stress in the food and beverage industry: Take one-part low margins, blend in one-part increased government regulation, one-part unannounced audits, one-part increasing customer demands, and one-part manual paperwork,” says Gary Nowacki, CEO of TraceGains. “Mix well, bake on high, then spread thinly with a limited pool of FSQA professionals.”
Anthony Arocha, customer success consultant at TraceGains
Nearly 500 FSQA professionals participated in the survey. In a two-part Q&A with TraceGains, Anthony Arocha (customer success consultant), Rajan Gupta (vice president of customer success), and Jason Ulrich (customer success manager) explain what the results mean in to the broader industry.
Food Safety Tech: Were there any surprises with this year’s survey?
Anthony Arocha: FSMA compliance is across the board a top priority with staffing/training as one of the biggest obstacles to overcome. I would say this is a huge opportunity for automation to help reduce the risk and long-term costs incurred by the increasing demand for accurate documentation.
22% and 19% cited training and staffing respectively as a big challenge. Graphic courtesy of TraceGains.
Rajan Gupta: I do not think there are any surprises but a very strong restatement that FSQA staff is difficult to hire/retain due to limited individual growth, low salaries, inadequate training, incentives, etc. All of these lead to the fact that most food companies look at food safety and quality as a nuisance that they must deal with versus as a function that is a necessity or a requirement with adequate funding.
Rajan Gupta, vice president of customer success, TraceGains
FST: With FSMA being a top priority among survey respondents, are you finding that companies are concerned about any of the rules in particular?
Arocha: Honestly, it seems that most folks are trying very hard to get a handle on all the new rules and what their responsibility is for compliance. Not sure they have gotten to the point of having just one or two main concerns yet. There is more emphasis on creating strong relationships with the downstream and upstream customers and suppliers than ever before. Some of the rules seem vague, which will require an operation to be prepared to support how they meet a particular requirement or may be potentially exempt from it. These have been some of the concerns that seem to be popping up most.
Survey Question: What, if anything, hinders your company’s ability to on-board, recruit, and retain skilled FSQA staff? (Graphic courtesy of TraceGains)Jason Ulrich, customer success manager, TraceGains
Gupta: The main theme that we hear from our customers is that there is confusion. Companies have had to deal with many requirements in the past, some of which conflict each other. I think lack of a thorough understanding of food safety within an organization is a key limiting factor to truly determine what is needed at each organization to meet FSMA guidelines.
Jason Ulrich: Companies are concerned about FSMA. Most are concerned with FSMA as a whole. Many have taken steps to educate themselves, but the law is vague, especially for companies that are in multiple areas of food manufacturing.
Yesterday the FDA, Canadian Food Inspection Agency (CFIA) and the Department of Health Canada signed an agreement that recognizes their food safety systems as comparable. Signed at an FDA-CFIA Health Canada Joint Committee on Food Safety meeting, the agreement will allow the agencies to leverage their regulatory systems and partner on various activities such as oversight when prioritizing inspections, scientific collaboration, and outbreak response.
“This arrangement is part of the US-Canada Regulatory Cooperation Council in which the countries intend to better align their food safety regulatory systems, reduce unnecessary duplication, enhance information sharing, and to the extent possible, leverage resources so that the agencies can better meet their public health objectives,” said Michael Taylor, deputy commissioner for foods and veterinary medicine at FDA in a statement.
According to an FDA release: “Systems recognition involves reviewing a foreign country’s domestic food safety regulatory system to determine if it has legal authorities and regulatory tools that together provide public health outcomes comparable to those provided by the FDA. Domestic systems provide the baseline level of public health protection that helps assure the safety of exported foods from that country. Systems recognition will help the FDA be more risk-based in planning the scope and frequency of its inspection activities, including foreign facility inspections, import field exams, and import sampling.”
The agencies used the International Comparability Assessment Tool to conduct a systems recognition review and assessment involving elements of Canada’s national food safety control system. This included examining laws and regulations, inspection programs, response to outbreaks, and other compliance, enforcement and lab support activities.
Learn innovative ways to mitigate the threat of Listeria at the Listeria Detection & Control Workshop | May 31–June 1, 2016 | St. Paul, MN | LEARN MORE–UPDATE–May 5, 2016–The CDC has reported that eight people have been infected with Listeria from three states from September 2013 to March 2016. According to an FDA release, whole genome sequencing conducted from a routine product sampling program by the Ohio Department of Agriculture revealed Listeria monocytogenes (Lm) from frozen corn and that it was closely related genetically to seven bacterial isolates from those sickened. It found a similar result from frozen peas, with an Lm isolate closely related genetically to one isolate from one person. “This close genetic relationship provides additional evidence that the people in this outbreak became ill from eating frozen vegetables produced by CRF Frozen Foods,” the release stated.
In March FDA collected environmental samples from Oregon Potato Company (also located in Pasco, WA), which were found to be closely related genetically to seven isolates of sickened people linked to the outbreak. As a result Oregon Potato voluntarily recalled its wholesale onion products. “FDA is working to identify other parts of the relevant supply chain that may have product relating to this outbreak. However, FDA is prohibited by law from releasing publicly certain information about supply chains, which may constitute confidential commercial information,” according to the release.
The agency is trying to determine whether there is a connection between product sample isolates and environmental samples taken. FDA called it a “complex and ongoing investigation”.
–END UPDATE–
Pasco, Washington-based CRF Frozen Foods has expanded a nationwide voluntary recall of its frozen fruits and vegetables over concerns that the products may be contaminated with Listeria. The recall, which also includes products sold in Canada, encompasses more than 358 consumer products sold under 42 different brands of frozen organic and traditional fruit and vegetable products that were manufactured or processed in CRF’s facility since May 2014. Seven people from at least three states have been sickened and hospitalized due to Listeria. According to an announcement on FDA’s website, “Some of these illnesses have been linked to consuming CRF-manufactured or processed products. CDC also informed us that, sadly, two of these individuals later died, but that Listeria was not the cause of death in either person.”
CRF suspended operations at its facility in Pasco, Washington on April 25 (following the first voluntary recall) and all affected retailers have been notified.
According to the FDA announcement:
“Products include organic and non-organic broccoli, butternut squash, carrots, cauliflower, corn, edamame, green beans, Italian beans, kale, leeks, lima beans, onions, peas, pepper strips, potatoes, potato medley, root medley, spinach, sweet potatoes, various vegetable medleys, blends, and stir fry packages, blueberries, cherries, cranberries, peaches, raspberries, and strawberries.”
Today the USDA announced that is providing $6 million in funding for research surrounding antimicrobial resistance. Available via the Agriculture and Food Research Initiative and USDA’s National Institute of Food and Agriculture, funded applications must tackle one or more areas:
Development of new systems approaches to investigate the ecology of microbial resistance microbes and gene reservoirs in the environment in animals, crops, food products or farm-raised aquaculture products
Development, evaluation and implementation of effective and sustainable resources and strategies. This approach includes alternative practices, techniques, technologies or tools that mitigate emergence, spread or persistence of antimicrobial resistant pathogens
Identify critical control points for mitigating antimicrobial resistance in pre- and post-harvest food production
Design training, education, and outreach resources (including web-based) that are adaptable by users across the food chain (from policy makers to producers and processors to retailers and consumers)
Design and conduct studies that evaluate the impact and efficacy of proposed research, education and extension/outreach interventions on antimicrobial resistance across the food chain
Learn innovative ways to mitigate the threat of Listeria at the Listeria Detection & Control Workshop | May 31–June 1, 2016 | St. Paul, MN | LEARN MOREOn Friday the news broke that the U.S. Department of Justice (DOJ) was investigating Dole Food Co. over the Listeria outbreak involving packaged salad. The deadly outbreak was linked to salad produced at Dole’s Springfield, Ohio facility. Although the DOJ has not yet commented on the criminal investigation, The Wall Street Journal reports that Dole reported positive Listeria samples at its facility as early as July 2014.
In January 2016, Dole voluntarily recalled all salad mixes produced at the Springfield plant, by which point 33 people in the United States and Canada had fallen ill with Listeria and four had died. The CDC reported on March 31 that the outbreak appeared to be over and Dole restarted production at the Springfield facility in April.
In a press release on the company’s website, Dole stated that the issues FDA reported at its Springfield facility have been corrected. “We have been working in collaboration with the FDA and other authorities to implement ongoing improved testing, sanitation and procedure enhancements, which have resulted in the recent reopening of our Springfield salad plant.” It also acknowledged that it had been contacted by the DOJ related to an investigation and will be cooperating with the department.
More effective environmental monitoring and improved sanitation practices, along with databases such as PulseNet, are helping the industry find Listeria contamination. However, once detected, many processing facilities have difficulty removing the bacteria.
Next month Food Safety Tech is holding a Listeria Detection & Control Workshop to educate food industry professionals about how to integrate prevention and mitigation procedures into existing sanitation, operation and testing programs. The two-day workshop, which takes place May 31 – June 1 in St. Paul, MN, will cover the basics of controlling Listeria, along with the following topics:
Detecting and penetrating biofilm
How to build an effective environmental testing program
Producing reliable testing to detect and control Listeria
Sanitation departmental role in prevention, control and mitigation
Building a master sanitation schedule
Innovative Listeria mitigation programs
Gaps in proactive food safety programs
Hygienic equipment design
Industry speakers include:
John Besser, Ph.D., deputy chief, enteric disease laboratory branch, CDC
Gina (Nicholson) Kramer, Savour Food Safety International
Dominique Blackman, Realzyme
Janet Buffer, The Kroger Company
Ken Davenport, Ph.D., 3M Food Safety
Bert de Vegt, Micreos Food Safety
Joellen Feirtag, Ph.D., University of Minnesota
Melinda Hayman, Ph.D., GMA
Sanja Illic, Ph.D., Ohio State University
Paul Lorcheim, ClorDiSys Solutions
Douglas Marshal, Ph.D., Eurofins Scientific
Jeff Mitchell, Chemstar
Megan Murn, Microbiologics
Robin Peterson, Micreos
Errol Raghubeer, Ph.D., Avure Technologies
The event takes place at the 3M Innovation Center in St. Paul, Minnesota. Workshop hours are Tuesday, May 31 from 11:00 am–6:00 pm and Wednesday, June 1 from 8:30 am–5:00 pm. For more information, visit the Listeria Detection & Control Workshop event website.
Economically motivated adulteration (EMA) has considerable economic ramifications, impacting businesses from a financial and liability perspective, posing dangers to consumers, and eroding product confidence. One of the biggest issues with monitoring the volume and type of adulterated products is the fact that the landscape of food fraud is ever changing. “The perpetrators are always two steps ahead, so innovation is needed to keep up,” said Jeff Moore, Ph.D., director of science, food program at U.S. Pharmacopeial Convention (USP), at the GMA Science Forum last week.
GMA and Battelle have teamed up to launch EMAlert, a tool that companies can use to quantitatively assess the vulnerability of their supply chains to EMA. The secure, cloud-based platform comes with 50 commodities off the shelf (including spices, grains, dairy, seafood, meat, oils, fruits, veggies, and food ingredients). It was developed fairly rapidly (Battelle, which serves as the technology provider, started development at the beginning of this year) and still needs to be validated; full validation will be presented at the IAFP meeting this summer. And if EMAlert lives up to its potential, it could help companies be more nimble in monitoring and acting on threats in their supply chain.
The purpose of the tool is to generate quantitative vulnerability results that allow people to make actionable decisions based on numeric values. As such, it has been designed to be dynamic and customizable, since every company has its own risk tolerance. In addition, it looks at real-time environmental changes, because you can’t have a static tool to monitor vulnerability when it’s always changing, said Joseph A. Scimeca, Ph.D., vice president, global regulatory & scientific affairs at Cargill, Inc.
A screenshot of EMAlert
“The EMA threat is changing,” said Ashley Kubatko, principal research scientist at the Battelle Memorial Institute. “A static assessment is only a snapshot in time.” EMAlert pulls live, automated data that takes into account economic drivers (value, volume, and scarcity of product), historical drivers (how often has product adulteration occurred in the past, geopolitical stability), and ease drivers (how frequently the commodity is tested; whether there are government regulations around the commodity group; how often the product changes hands or is repackaged). Data is pulled from several databases, including FDA, UN Comtrade, USP, Quandi, and Transparency International.
When creating the tool Battelle borrowed from its approach in working with the U.S. Department of Homeland Security to develop models that predict terrorist decision making and used the same mathematical methodology, providing a predictive model of fraudster behavior. Keeping in mind that perpetrators are also constantly monitoring how law enforcement and industry is keeping track of their strategies, EMAlert not only requires a subscription, but Kubatko says that Battelle will also be monitoring its users to ensure there is no suspicious activity within EMAlert.
WATCH VIDEO I: Apply Behaviorial Science Techniques to Food Safety Most people are influenced by the behavior that surrounds them, especially in a professional environment. In part III of a video series of his presentation at the 2015 Food Safety Consortium, Frank Yiannas, vice president of food safety at Walmart, discusses the key role that behavioral science plays in food safety culture and how companies can build a stronger culture by considering the principle of social norms.
Yiannas also touches on how learning through the mistakes of others can be an effective teaching tool.
“I think we have to teach food safety the wrong way sometimes to teach it the right way,” said Yiannas. “I think a lot of food safety professionals create curriculum and modules that are teaching it the right way…when the research is clear—teaching the wrong way can be pretty good.”
Since 2002, the amount of FDA-regulated food imported to the United States has nearly doubled. With the implementation of FSMA well underway, expect that FDA will be increasing its inspections at foreign manufacturing facilities. When prioritizing inspections, FDA looks at a facility’s compliance history, the risk of the product manufactured in the plant, the date of its last inspection, and any import alerts associated with the site.
First and foremost, it’s important to make sure your foreign facility understands what a food safety plan under FSMA requires, said Chengboey Lau, principal scientist for North America scientific & regulatory affairs at Mondelēz International. Today at the GMA Science Forum Lau pulled from the experience of Mondelez (the $30 billion-company has more than 165 manufacturing plants worldwide and requires all of its suppliers to be GFSI certified) to provide some helpful tips on how a company can get ready for an FDA inspection of a foreign facility, what it should do during the event, and the steps that should be taken afterwards.
Prepare for the Inspection
Develop an internal policy for foreign inspections
To ensure readiness at all times, implement a proactive program that involves the following activities
Annual review of registered facilities
Review of any products or materials made for U.S. markets (including R&D samples)
Gap assessments to ensure compliance with FDA requirements, followed by an action plan to close identified gaps
Employee training on FDA requirements
Create a site-specific FDA inspection manual for all necessary documentation
Survive the Inspection
Align expectations with the inspector at the start of the inspection
Have an employee who has strong English skills present to help with translation (the employee should have an understanding of American slang, too)
Consider having a U.S. regulatory support colleague available for questions during the inspection
Post-inspection
Email the inspector or make a Freedom of Information Act request if you don’t receive an establishment inspection report after six months
If a form 483 letter is issued, respond in writing within 15 days, and follow up within 40 days to inform FDA of the completion of any corrective actions
At the end of the day, make sure you have a firm understanding of which final FSMA rules apply to your organization, advised Lau. From there companies should perform a gap analysis, identify the resources necessary and any constraints involved, train employees on the new FSMA expectations, and be prepared to implement new and/or modify current policies and procedures to ensure inspection readiness.
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