Is Raw Manure Dangerous to Produce Safety?

By Food Safety Tech Staff

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.

Brian Bedard, GMA, Food Safety Consortium

March 2, 2016

Food Safety Culture Series: Where the Leaders Are

By Maria Fontanazza

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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).

February 29, 2016

Senate Confirms Califf to Head FDA

By Food Safety Tech Staff

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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.”

February 25, 2016

Food Safety Culture Series: What’s the Controversy?

By Maria Fontanazza

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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: 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: 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.

February 22, 2016

Contamination, Adulteration Remain Highest Priority

By Maria Fontanazza

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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.

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.

February 18, 2016

Next-Generation DNA Sequencing Finds Unexpected Contaminants

By Food Safety Tech Staff

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With more regulatory and consumer scrutiny being placed on the authenticity of food products, companies must use technologies that can verify products and ingredients, and detect contaminants. NSF International recently acquired AuthenTechnologies, a testing laboratory that provides DNA-species identification services to improve authenticity, safety and quality of natural products. Using shorter segments and validated reference materials, AuthenTechnologies employs a DNA sequencing method that can identify “almost any” species and detect contaminants that cannot be distinguished morphologically or chemically. The method also screens for allergens, GMOs, fillers and filth.

“As the food supply chain becomes more complex and regulations continue to evolve and become more rigorous, this technology is becoming essential to achieving regulatory compliance and brand protection while preventing issues associated with fraud, mislabeling and adulteration,” said Lori Bestervelt, Ph.D, international executive vice president and chief technology officer at NSF, in a company release. AuthenTechnologies’ co-founder Danica Harbaugh Reynauld, Ph.D., adds, “We’ve developed a more highly specific DNA methodology capable of identifying a single organism to a complex blend of unlimited ingredients.” Reynauld, who will join NSF as global director of scientific innovation, will lead the NSF AuthenTechnologies center of excellence with NSF’s global network of labs.

In comparison to DNA barcoding, next-generation DNA sequencing is highly specific and can identify species in highly processed materials and complex mixtures. DNA barcoding is unable to differentiate between closely related species and is less suitable in detecting extracts as well.

February 17, 2016

GFSI and the Road to FSMA

By Maria Fontanazza

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Many companies certified to a GFSI scheme appear to have a leg up on preparing for FSMA, especially in the area of documentation and record keeping. During a quick chat with Food Safety Tech, Bob Butcher, group operations manager at Ipswich Shellfish Company, explained how GFSI has helped the seafood processor get ready for FSMA. Do you agree? Sound off in the comments section.

Food Safety Tech: What common challenges do companies experience when managing compliance with a GFSI scheme?

Bob Butcher: Every time there’s a new regulation it’s a matter of understanding how that regulation applies to us. The seafood industry has been regulated by FDA mandatory HACCP requirements for years now. Some of the items that are covered under FSMA have already been covered by the seafood regulations. Our facilities have also undergone third-party audits for a number of years and three are already SQF certified—so in order to meet those certifications, we comply with all the FSMA requirements at this point. That being said, there’s always a challenge or opportunity to make sure we comply with all the regulations and above that, make sure that the quality [of the product] we send to our customers meets both their standards and our standards.

FST: Has being certified to a GFSI scheme helped your company better prepare for FSMA compliance?

Butcher: Because we’re SQF certified and are meeting most of the requirements of the seafood industry, we’re well ahead of meeting FSMA requirements. Maintaining the GFSI requirements put us in great shape for FSMA.

GFSI covers so many areas. [Regarding] vendor compliance, we critically examine the seafood that comes in every day and it’s a very perishable commodity, but every plant is a little different in the talent they have and the number of people. We’ve been able to focus on making sure that the product meets the same criteria at each of the facilities no matter who is receiving it and documenting it accordingly. And whether [complying with] GFSI or FSMA, documentation is important.

We’ve gone the extra step in automating so we can better track how each of the plants and suppliers are performing. We started rolling it out at one plant two years ago and then extended it to all plants. All of our facilities have been under it for a year.

I think more and more companies are acknowledging the need to automate. With paper forms it’s difficult to make sure the employee has the correct and latest version, and the filing and recovery of that document [is difficult]. If it’s digital, you can get your hands on the latest version any time you want. Plus, you can analyze digital information and easily look for trends.

However, the seafood industry isn’t like a number of other industries—the margins are low, and so cost is absolutely a factor. If it’s a single facility, having paper forms, depending on the extent of the operation, may be acceptable. But if you get into multiple locations, it’s a whole different challenge all together.

FST: What are the broader issues that the seafood industry is currently facing?

Butcher: Supply and sustainability—making sure that you have a handle on the sustainability of the species and are able to explain that to your customers. That ties into record keeping—getting the right product, when it’s an MSC [Marine Stewardship Council] or ASC [Aquaculture Stewardship Council] chain of custody, or whether it’s having the right relationship with the vendors so you know your source. Cost is a concern, along with quality and inventory levels.

There are a lot of very small companies and a lot of them aren’t GFSI certified. A lot of them don’t even have any type of third-party audits, so I’m not sure how ready they are. It’s always a challenge for a small company to get up to speed.

FST: Does compliance with a GFSI scheme help address these issues to some extent?

Butcher: As we started working on GFSI or FSMA, and even HACCP many years ago, we started looking at products differently. You’re documenting more and gaining information—and once you have that information, you can focus on cost factors and inventory. So from that standpoint, it has been very helpful. At this point, we’re SQF Level, and we plan to go Level 3, which involves more quality parameters and certification. That will greatly impact the product and the profitability as well.

FST: What are your tips for companies in terms of being audit ready?

Butcher: The software program we use helps us maintain our facilities to be as audit ready as we can from a documentation standpoint. With SQF there will be unannounced audits, and it’s always been FDA’s practice or the state inspector’s practice to pop in anyway, so you have to be ready for that inspection at any time. The whole principle of HACCP is to make sure you’re documenting what you’re doing. And whether it’s an auditor or an inspector, they’re coming in at any time and can look at records for the past two years, so you should be in compliance and be able to prove that.

February 16, 2016

PCR Assay Detects Listeria in Dairy, Produce, RTE Products

By Food Safety Tech Staff

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The AOAC Research Institute approved a method extension of Performance Test Method #030502 to include the DuPont BAX System X5 PCR Assay for Genus Listeria. The assay has been validated as a reliable method for detecting the pathogen in frankfurters, smoked salmon, spinach, and cheese, as well as from environmental surfaces. Using the system, automated PCR-based DNA amplification and automatic pathogen detection can be conducted on 32 samples simultaneously within a smaller and more lightweight unit. The system is also validated by AOAC-RI for detecting Salmonella and Listeria monocytogenes in good and environmental samples.

Gary Smith, Eurofins’ Food Safety Systems

February 15, 2016

FSMA Mandates Employee Training. Are You Prepared?

By Maria Fontanazza

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Training plays a huge role in the effective implementation of FSMA. The preventive controls for human food final rule calls out areas in which training is now obligatory, namely ensuring that employees involved in the manufacturing, processing, packaging and holding of food are properly educated on food safety and food hygiene (mandated under Current Good Manufacturing Practices). FDA has initiated an extensive training strategy, part of which includes establishing a National Coordination Center (the agency awarded a $600,000 grant to the International Food Protection Training Institute in October), along with several collaborative efforts with other federal agencies and industry partners.

Although many food companies have been conducting training as part of their standard procedures, preparing employees for the implementation phase of FSMA may be more complicated than they anticipated. In a Q&A with Food Safety Tech, Gary Smith, director of food safety services at Eurofins Scientific, shares insights on some of the hurdles that industry is encountering (including manufacturers in the animal food arena) related to training and FSMA compliance.

Food Safety Tech: How has FSMA changed the landscape of employee training?

Gary Smith: There are a couple of updates that are very important to note for the industries as a whole. First, employee training is now mandatory for both human food facilities and, probably even more importantly, animal food facilities. Many of the human food folks may have been asked by customers or by other entities via corporate internal procedures to do training of employees and to have a training program in place. For a lot of the pet food and animal feed manufacturers, having a comprehensive training program for all employees is significantly different than what has been requested and expected of them in the past.

Second, the preventive controls rule for both human food and animal food specifically requires that animal food and human food manufacturers conduct training of all their employees on at least food safety and food hygiene topics. Now, what does that mean? We’re interpreting that to mean basic GMPs as well as common food safety hazards. Realistically, this will probably be a 30 to 60-minute training session in which everyone in the facility will have to attend, and FDA doesn’t state specifically that it has to be done more than at least once. There is no frequency for re-training. However, once the compliance dates are effective, it’s mandatory that the training has been completed. This is a new concept for the majority of industry who may have had corporate training programs or customer-driven training programs, but never a mandated regulatory requirement for training.

FST: What challenges do food companies face in ensuring that employees are prepared for the implementation phase?

Smith: There’s the challenge of putting together the training, which, in the big picture of FSMA, shouldn’t be that big of a deal.

Some of the biggest challenges companies face (especially in trying to get ahead of the game and be proactive) is the identification of the preventive controls qualified individual. Is it an internal person? Is it a consultant? Do they have to go through a specific training class? The answer is yes, they do. How do they deal with foreign suppliers? A lot of folks are really confused about the concept of the Foreign Supplier Verification Program rule and what it means. Do they need to audit [their suppliers]? Do they need to be GFSI certified? There are a lot of questions concerning the importation of ingredients from outside the United States—what’s the requirement? This is probably the biggest area in which people seek clarity.

Another [challenge] is internal supplier approval, because the new rule talks about supplier approval as one of the preventive controls that has to be in place. Again, who can do those audits? When do we have to conduct an audit? What does the audit have to cover? A lot of folks are struggling with this area as well.

The last challenge: A lot of folks have HACCP, whether they are human or animal food manufacturers, and this has been required or requested by customers for a while. But how do we transition from having a HACCP plan to a food safety plan that meets the preventive control requirements in addition to the HACCP requirements? How do I build in allergen management as a preventive control? How do I build in sanitation as a preventive control? How do I build in supplier approval as a preventive control? There are a lot of questions surrounding whether companies should scrap their HACCP plan and start over, or whether they have to add on to it.

FST: Eurofins offers an extensive training schedule for the first half of 2016. How do these offerings play into FSMA’s compliance requirements?

Smith: Eurofins is now offering the highly anticipated 2.5-day training created by the FDA’s Food Safety Preventive Controls Alliance (FSPCA). The standardized curriculum is designed to meet the training requirements under Title 21 Code of Federal Regulations Part 117.115 for the “preventive control qualified individual” who conducts certain Food Safety Plan activities. In addition, Eurofins offers core courses such as Environmental Monitoring, Internal Food Safety Auditing and HACCP to help support the development and implementation of a company’s food safety plan.

February 12, 2016

Part of FDA FY 2017 Budget Request to Hold Food Importers Accountable

By Food Safety Tech Staff

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UPDATE 2/22/2016 – According to an updated FDA alert, the FY2017 budget requests include an increase of $25.3 million of new budget authority to implement FSMA, with FDA focusing on two main areas:

National Integrated Food Safety System ($11.3 million). Support state capacity to implement the produce safety rule via education and technical assistance to farmers and on‑going compliance support and oversight

New Import Safety Systems ($14.0 million). Implementing the FSVP rule, which makes importers responsible for ensuring that the foods they bring in from other countries are produced in a manner that is consistent with U.S. food safety standards

– END UPDATE –

FDA wants 8% more money for its FY 2017 budget, requesting a total of $5.1 billion. Part of this $14.6 million net increase in budget authority will go toward FSMA implementation. Specifically related to food safety, FDA is asking for more than $18.4 million in budget authority and more than $193.2 million in user fees. According to an FDA press release, the agency will be using the budget to support federal and state efforts related to enforcing safety standards on produce farms. In addition, FDA wants to use the money “to hold importers accountable for verifying that imported food meets U.S. safety standards, as well as conduct food safety audits of foreign food facilities”.

FDA is also requesting more than $3 million for building and facilities funding, and more than $600,000 to support other areas to improve the agency’s infrastructure. The fiscal request is for October 1, 2016 through September 30, 2017.

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