At this year’s IAFP 2015 conference, there was a lot of buzz surrounding food safety culture and employee behavior. Laura Nelson, vice president of business development at Alchemy, shares her insights on the importance of empowering employees. This is achieved through providing training that gives them the confidence to make immediate decisions on the facility floor.
“We have to own the fact that employees are the key. They are exposed to the product and they’re really the ones touching our food every day,” says Nelson. “And yet, we don’t do a really good job at training and measuring that effectiveness in their execution of the behaviors that we train them on, on the plant floor.”
In the following video, Nelson talks about what industry is doing right in food safety culture, and the areas in which improvement is needed moving forward.
With publication of the first set of final rules for FDA’s Food Safety Modernization Act (FSMA) expected any day now, food safety teams are busy strategizing as to how they are going to prepare for compliance and be “FSMA-ready” on Day 1.
Across industry, it is generally agreed that being certified to a GFSI scheme is a solid foundation for FSMA compliance. In a new three-part online series, “GFSI in the Age of FSMA: How GFSI Schemes Align With and Prepare You for FSMA”, the North American leaders of the three major GFSI schemes – SQF, BRC and FSSC 22000 – will discuss the following topics:
How certification to their scheme prepares a company for FSMA compliance in terms of alignment with:
Supplier Controls
Building a food safety plan
Migrating from HACCP to HARPC
Being audit ready all the time
Environmental monitoring … human & animal food rules … and much more
What changes to the scheme have been made (or are planned) to better align with FSMA
Gaps the leaders see in FSMA that are filled by their scheme
What companies who are, or plan to be, GFSI certified should be doing now for Day 1 FSMA compliance
(left to right) John Kukoly of BRC, Jacqueline Southee of FSSC 22000, and Robert Garfield of SQFI are the featured speakers of the GFSI series.
Food company teams working in Regulatory, Food Safety & Quality Assurance, Operations, C-Suite, Legal and other related positions in companies who are – or are planning to become – certified in a GFSI scheme are encouraged to attend one, two or all three sessions.
The series is being sponsored by SafetyChain Software with media partner Food Safety Tech.
As FSMA promises to increase the responsibility of food laboratories, companies must pave a path forward by working more closely with industry as a whole, government and non-government organizations, as well as with each other. This was the clear message relayed by Pamela Wilger , assistant director of global food safety at Cargill, at IAFP 2015.
“We consider a lab any person generating data,” said Wilger, who emphasized the “lab” is not just the room itself. Lab testing should not focus on a single narrow view (i.e., one test); companies should be efficiently applying their resources, considering both science and risk. “Non-science based testing can lead to conflicts between suppliers and customers and manufacturers and regulators, and destruction of wholesome product.”
Here’s where improvement is needed in food labs:
Disseminating best practices. “We don’t even share that [as an industry],” said Wilger. “We don’t have time to replicate the same work.”
Aligning international rules
Cooperating with national regulators, including local/regional entities.
Testing and improving compliance policies
Building consumer trust and confidence
Training/competency development. Finding the right people, and encouraging employee knowledge sharing
Being prepared for the next intentional economic adulteration
Palmer Orlandi, Ph.D., CAPT, U.S. Public Health Service Sr. Science Advisor in the Office of Foods and Veterinary Medicine at FDA, shared insights on how FSMA will affect lab responsibilities moving forward, with a focus on prevention versus reaction. The objective for lab capacity programs is to facilitate submission and acceptance of meaningful and actionable data to all regulatory agencies, he said.
Reset, expand and integrate: A need to focus on resources
Method performance and “fit for purpose”, harmonized standards
Large-scale focused surveillance activities; statistical significance, real-time evaluation of data generated
Real-time communications, bioinformatics, IT infrastructure, data-sharing platforms
Technology and innovation partnerships, including on an international basis
With the upcoming regulations right around the corner, the good news is that FDA is still on track to meet the FSMA deadlines for August (preventive controls for human and animal food). But as industry looks to the future of FSMA and its implementation, resources and funding will be a challenge. Michael Taylor, deputy commissioner for foods and veterinary medicine at FDA, continued this message (which he declared several months ago) at the 2015 IAFP conference in Portland, OR.
“We’ve been given a brand new mandate by Congress to do things we haven’t done before,” said Taylor, as he emphasized that FDA will be in a do-more-with-less resource-challenged state. FDA would need, over the five years following the enactment of FSMA, $580 million, said Taylor. Over the first five years, FDA has received about $162 million (through 2015). “2016 is the absolute crunch year for FSMA funding,” he said. President Obama’s budget request for FY2016 would provide $109.5 million.
The issue is that there simply isn’t enough funding to get it all done, or as Taylor put it, not enough money to “maintain momentum towards comprehensive implementation of the FSMA vision.” As a result of the funding limitations, Taylor said that FDA will be making “hard choices” and will be forced to prioritize the funding that it receives. He indicated that the agency will focus on preventive controls implementation first. But this leaves a potential for disruption due to the investments needed for implementing the produce safety rule and building a strong system for imports, which may pose the biggest challenge over the next decade, Taylor warned. While trying to remain positive, the deputy commissioner also maintained that he wanted to be transparent about the situation.
FSMA will give FDA the ability and technology to act in real-time when issues occur, but it will also require new skills and training, as well as a shift in culture. In November, Taylor will be the opening plenary speaker for the Food Safety Consortium Conference and will surely have more insights, as industry will be entering the implementation phase.
The presence of Listeria monocytogenes in retail establishments can become a persistent problem. While maintaining vigilant and strict cleaning practices is key to reducing the risk, Haley Oliver, Ph.D., associate professor of food science at Purdue University cautions there is no silver bullet for a cleaning strategy, because every store is different. The rate of Listeriosis has not decreased but rather has plateaued, and controlling Listeria is a growing problem, forcing it to be a hot topic at this year’s IAFP conference.
“Attempting to regulate an industry as broad as retail in the United States is a huge challenge,” said Kevin Smith, Ph.D., senior advisor for food safety at FDA’s Center for Food Safety and Applied Nutrition. According to Smith, more than 2200 agencies are responsible for the licensing and inspection of retail facilities. Due to the massive size of the industry, much of the actions surrounding driving compliance and enforcing regulations occur through state, local, and tribal authorities.
The Food Safety and Inspection Service (FSIS) attributed 83% of Listeriosis cases to deli meats that were sliced at a retail counter, (as opposed to meats prepackaged at a facility). Retailers should be using the FSIS guidelines released in June, “Best Practices Guidance for Controlling Listeria monocytogenes in Retail Delicatessens“, for specific information about how they can ensure the safety of products such as deli meats. Revisions to the guidance include a clarification that food processing equipment should be taken apart during cleaning and sanitizing; an added recommendation that retailers scrub surfaces during cleaning to prevent biofilm formation; and clarification that retailers rotate sanitizers to avoid development of resistance. According to Kristina Barlow of FSIS, these practices can extend beyond deli meats to any products that are prepared at retail.
Barlow outlined areas that the Listeria best practices guidelines address, including:
Product handling. “Use products formulated with antimicrobial agents to prevent growth of Lm—96% illnesses could be reduced if retailers used these products,” said Barlow.
Cleaning and sanitizing. It is recommended that retailers develop written sanitation procedures outlining the daily frequency in which utensils and equipment should be cleaned and sanitized. Equipment should be cleaned every four hours, and surfaces scrubbed to prevent biofilm formation. Barlow advised that retailers document all actions they perform to ensure that procedures are carried out each day.
Facility and equipment controls. Ensure that the floors, walls and overhead structures are clean. Listeria that is harbored in drains is more likely to creep its way into equipment, and the bacteria can also hide under dust and floors, so it is important to avoid construction when food products are exposed.
Employee practices. Use gloves, train in sanitation practices, and make sure that information is available to employees in multiple ways (i.e., other languages and use of images). In addition, implement policies to ensure that ill employees are not working with food; and limit employee traffic in the deli area—develop traffic flow plans for product, employees and other items to prevent contamination by both consumers and employees. Finally, employees should change aprons or other frocks when soiled. “Gone are the days when the butcher is covered in blood [and] serving people,” said Barlow.
Manual management of HACCP and HARPC plans is often a resource-intensive and inefficient process that can create a data rich vs. information poor sentiment. Next week Dan Bernkopf, vice president of food safety applications at SafetyChain, will share insights on how companies can use automation to help assess risks to effectively create critical control points and preventive controls, during a webinar, “Conquering HACCP/HARPC Plan Management: The Power of Automation”. He will also share insights to help companies learn how automation can ensure that HACCP and HARPC plan components are scheduled, monitored and documented.
How else can automation help companies with their HACCP and HARPC plans?
Provide real-time non-conformance reports for CAPAs, minimizing waste and rework
Leverage mobile technology to collect food safety data at the source
Conduct meaningful trend analysis for continuous improvement with accessible, actionable data
Be audit ready for USDA, FDA and customer inquiries
Pathogen enrichment is a critical part of any microbiological testing workflow.
Pathogen detection – made challenging with the increase in numbers of composite samples that require even larger volumes of media per sample – are time-consuming and involve bulky media handling by laboratory personnel. Not only do these factors make life in the lab more difficult, but also, they increase the risk of introducing contamination.
The following questions provide insight into more efficient ways to prepare media.
Q: What are some ways to manage the increased media production requirements, and what are some of the bottlenecks in the media kitchen when dealing with composite samples for pathogen testing?
A: Composite samples are larger than traditional food samples and therefore require the addition of more culture media before incubation. Larger volumes of media preparation (i.e. sorting, autoclaving) is one of the largest sources of bottleneck for composite samples for pathogen testing. It’s not unusual for several hundred composite samples to be tested daily on a regular basis – this situation is only magnified when managing composite samples that require up to 15 times more than a traditional sample.
The issue with large volumes of media is that media containers and samples are fairly heavy and cumbersome to move, with equally demanding turnaround time. For these reasons, the entire process must be industrialized to maintain lab productivity.
Choosing a media that is composed of premium raw materials ensures high recovery and growth rates of bacteria, which are essential for the subsequent use of rapid testing methods. Additionally, selecting a media that meets industry performance standards as described in ISO 11133, helps reduce required quality control measures.
Q: How can I increase my media production without having to scale up my media kitchen to handle the workload?
A: Merck Millipore’s Readybag® media pouches with granulated culture media enable pathogen testing of composite food without making major changes. Readybag media pouches do not require capital equipment investment and involve less labor than both high efficiency and traditional methods for sterile media production. Use of pre-weighed, gamma-irradiated Readybag pouches eliminate all preparation steps and reduce typical sample preparation and autoclaving time by more than 50 percent. Performance tests confirm that Readybag media provides equivalent results compared to non-irradiated, autoclaved culture media.
A study performed by Cherney Microbiological Services (Green Bay, WI, USA) demonstrated the time, utility and space savings using Readybag granulated enrichment media for composite food samples as compared to both high efficiency and traditional preparation methods using autoclaving. The study examined the labor required, media cost, utility and associated electricity costs for each of the three methods (traditional autoclave, high efficiency and Readybag method). Observations and measurements were made using laboratory personnel within the normal workflow of Cherney’s laboratory.
The agency wants to establish a user fee program to facilitate audits.
About 15% of the U.S. food supply is imported. And within that figure nearly 80% of seafood, 50% of fresh fruit, and 20% of vegetables come from outside the United States, according to FDA. Under FSMA, the commitment to ensuring the safety of imported foods is a high priority. FDA is releasing a proposed rule, and a companion draft guidance document, to aid foreign entities in proving that they are meeting food safety import requirements.
Accreditation bodies (ABs) submitting applications or renewal applications for recognition in the third-party accreditation program
Recognized ABs and accredited CBs that are participating in the third-party accreditation program and subject to FDA monitoring
Certification bodies (CBs) submitting applications or renewal applications for direct accreditation
In addition to naming those subject to the user fee, the proposed rule defines how the fees would be computed and collected, the agency’s public notification process, and what happens if those subject to the fee do not pay it (i.e., suspension of recognition).
Today FDA announced the winner of the 2014 Food Safety Challenge. The Purdue University team snagged the $300,000 grand prize for its physical method for concentrating Salmonella to detectable levels via automated microfiltration. The technique can potentially reduce sample preparation time from 24-48 hours to a two- to three-hour timeframe.
Runner-up Pronucleotein received $100,000 for its portable device that enables rapid pathogen screening via DNA aptamer-magnetic bead sandwich assays.
A notable section of the Food Safety Modernization Act (FSMA) calls for the development and implementation of model laboratory standards. To ascertain the level of laboratory standards currently employed by food laboratories, a laboratory testing services company commissioned a survey of laboratory directors, quality assurance managers and technical supervisors. One area of questioning focused on certified reference materials (CRM).
According to a recent survey, more than 50% of laboratory directors, quality assurance managers and technical supervisors report using certified reference materials. (Click to enlarge)
In response to whether their laboratory uses CRM, 65% of respondents said yes. Most of the remaining survey respondents (31%), volunteered that they sometimes use these materials, if required. Only 4% replied “No” (see Figure 1).
The responses are significant in that they provide a glimpse into current food laboratory quality practices. FSMA tasks the U.S. Department of Health and Human Services with making certain that analytical procedures and quality systems are established and followed. Yet, it is not clear what procedures and systems are currently employed. This survey provides a baseline measure from a segment of the food laboratory community, indicating, that a majority of respondents use certified reference materials.
Quality Controls vs. CRM
A food laboratory aims to provide the correct result every time a test is performed. In order to achieve this consistency and reliability, laboratories should use standard measurements, known as quality controls. Quality controls are essentially the stable norm against which testing processes and instruments may be assessed. By using quality controls, it is possible to find areas in the testing process that may be weak or failing.
CRM, used as a form of quality control, are highly characterized, homogenous, authenticated control materials. Food laboratories often have options available for obtaining commercially sourced materials for quality controls, but not all of these options are well characterized or authenticated. CRM are used by laboratories to assess the quality of method validation as well as to trace to an established standard. In the food lab, CRM help provide a level of certainty in the results when instruments and processes are validated and verified. CRM may be obtained from accredited producers, as established under ISO Guide 34.
The survey also asked whether on-site and contract laboratories use quality controls. Interestingly, not all laboratories surveyed are using quality control materials as part of their testing processes and procedures. For on-site laboratories, 81% of survey respondents acknowledged using quality control materials. For contract laboratories, the number slips to 67%. For survey respondents not using quality control materials, it is unknown if or how their test results are validated and verified.
Quality control is a basic component of laboratory testing as well as a requirement for accreditation. Whether CRM or non-certified reference materials are used, quality controls are important components needed to ensure test results are valid and reliable for food consumers and industry alike. As future FSMA rules on model standards are likely to address this essential provision of laboratory testing, these survey results support the use of CRM.
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