Tag Archives: FSMA

Randy Fields, Repositrak
FST Soapbox

What Comes After FSMA?

By Randy Fields
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Randy Fields, Repositrak

The initial deadlines for Food Safety Modernization Act implementation are upon us, and while it will be a year or more before companies must comply with the regulations, now is an appropriate  time to consider the happens next with food safety in the United States. Packaging requirements, issues with imports, the move toward clean labels, updating facility auditing requirements, and a wide set of compliance issues will be near-term time-consuming issues for food safety directors and executives all the way up to the c-suite.

FSMA is the most impactful set of safety regulations to hit the grocery and restaurant industries since before World War II. But there are other elements of consumer protection that will quickly capture the attention of supermarket and foodservice executives after August, and smart companies are already looking ahead to ensure a competitive advantage.

Packaging requirements aren’t just limited to country of origin labeling. Consumers are demanding full transparency from manufacturers and the retailers from which they buy their food. Shoppers are demanding clear descriptions of what they’re eating and voicing their displeasure for companies that are not providing the details they want by buying competitive items. A quick look at the comparative sales of the big processed food companies during the last few years verifies this isn’t a fad.

Tainted imported food (for both humans and pets) nearly a decade ago was a key trigger for the legislation that ultimately became FSMA. While the act addresses record keeping and some elements of lab testing, there are still several issues to tackle, including third-party validation rules and the voluntary program for importers that provides for expedited review and entry of foods.

The move toward clean labels or reducing the number of ingredients in processed food is taking form in several different ways. For example, many manufacturers, particularly those that make products targeting young consumers, are eliminating high-fructose corn syrup from their product lines to address consumer concern about the impact the ingredient is having on obesity and other health issues.

Updating facility auditing requirements, at retail, foodservice and manufacturing operations, has been largely left to trade associations and the companies themselves. A single incident of foodborne illness or death linked to a store commissary, a restaurant or a processing facility is all it will take for consumers to demand government action to raise standards and increase inspections.

On compliance issues, FSMA requires companies to collect verification data of their supply chain’s adherence to regulations for up two years and have it accessible within 24 hours. Similar to Sarbanes-Oxley, CEOs are responsible for verifying the compliance of their supply chain under FSMA.  Given these risks, companies have started to automate their management of compliance documentation. Now forward-thinking companies are applying the same technology to ensure that information supplied by trading partners on products such as gluten-free goods or items containing nuts is frequently updated to avoid lapses that could lead to lawsuits and worse.

There certainly are a few different visions of the future of food safety. One commonality is that consumers will continue to demand an even safer food supply chain.  If companies don’t pursue this goal, legal action or governmental regulation will step in to encourage change.

Food Defense Culture is Coming

By Maria Fontanazza
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FSMA’s proposed rule on intentional adulteration isn’t the only reason companies should be paying attention to food defense.

Establishing metrics in food defense, similar to the growing awareness around the importance of measuring behaviors in a food safety culture, was a topic recently brought up at FDA’s FSMA public meeting in the spring. The agency acknowledged that it will need to both clearly define what exactly is intentional adulteration and how it can be measured.

While food safety involves assessing and mitigating hazards, food defense is all about the threat and protection against intentional contamination. “The threat of fraud is a growing problem as supply chains get more complex, resources grow scarcer and the cost of food increases. All this provides more opportunity and potential reward for food adulterers,” stated a recent PwC report on food trust.

The FSMA final rule Focused Mitigation Strategies to Protect Food Against Intentional Adulteration is scheduled to be published in spring 2016, and companies need to be revisiting and revamping their food defense plans to prepare.

Prevention is the key word and on the most fundamental level of a food defense plan, businesses need to have management commitment before building, or even revisiting, a food defense plan—do they understand the resources, time and cost involved?

Conducting a vulnerability assessment is the first step in finding the gaps and examining whether a facility is secure. Beyond the standard questions that companies may ask when embarking on this assessment, businesses should identify potential attackers, asking how an attacker could have access to a product or process and what would be the outcome of an attack. Then look at the protective measures that are already in place—would these act as a deterrent? And if deterred, would the attacker proceed to the next target or would he or she stop? What measures are in place to find the attacker before there is an effect on the product?

When developing a food defense plan, there are several areas of potential vulnerability:

  • Shipping and receiving and packaging
  • Laboratories and testing sites
  • Recall and traceability programs and processes
  • Water used in processing/manufacturing—what is its origin?
  • Employees—what are the health risks? Is there a process for employee health reporting? Is there a process for reporting disgruntled employees?
  • Security personnel

With food fraud on the rise, it’s important for companies to continue to revisit and update their food defense plans, considering changes to facility designs or strategies, packaging changes, security improvements, etc. Companies should also be proactive in monitoring their employees both from a satisfaction (reducing the incidence of a disgruntled employee) and awareness perspective. FDA has initiatives to help companies build a food defense culture and employee awareness, including the ALERT training course for owners and operators of food facilities and Employees FIRST, and the National Center for Food Protection and Defense has programs aimed at workforce training as well as undergraduate and graduate curriculum on food defense.

FSMA Final Rules Almost Here, Guide to GFSI

By Food Safety Tech Staff
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With a host of mandatory requirements under FSMA means, businesses may want to consider GFSI certification.

The first FSMA deadlines are now two months away, and manufacturers may wonder how and where GFSI certification ties into increased regulation. First, what are some of the main differences between GFSI and FSMA? GFSI is seen as more global, while FSMA is more US-focused. Of course, the final FSMA rules will require mandatory compliance, and GFSI is voluntary. However, GFSI certification is recognized among major domestic and international retailers, so compliance with a GFSI-recognized scheme is an important part of a company’s food safety program.

The Food Safety Consortium Conference features a GFSI Services & Compliance track. With increased regulatory demands under FSMA, speakers will discuss the role of food safety certification systems. A GFSI-certified facility is one step closer to compliance with FSMA and may be held in higher regard by FDA from an auditing and inspection standpoint versus a business that has not opted to obtain certification.

Obtaining GFSI certification provides several benefits to the food industry, according to a recent TraceGains blog about the GFSI journey, including:

  • Reducing duplication of audits
  • Creating a comparable audit approach and outcomes
  • Enabling continuous improvement and customer opportunity for GFSI-benchmarked companies
  • Enhancing trade opportunities
  • Gaining cost efficiencies throughout the supply chain
  • Increasing competitiveness in the global market

Several food safety management schemes are recognized by GFSI. Among them is FSSC 22000, which touts the certification of more than 10,000 businesses worldwide. This year’s Food Safety Consortium also includes the first FSSC 22000 North American Harmonization Day on Tuesday, November 18. The meeting will provide a technical update of FSSC 22000, along with current scheme and future plans for expanding scopes and preparing for GFSI benchmarking.

Randy Fields, Repositrak
FST Soapbox

Despite FSMA Exemptions, Compliance Will Not Be Optional For Small Suppliers

By Randy Fields
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Randy Fields, Repositrak

The product recall at Blue Bell Creameries earlier this year is yet another example of food safety issues negatively impacting food marketers, growers, processers and manufacturers. We all remember the Peanut Corporation of America’s salmonella outbreak in 2008 and the Jensen Farms listeria outbreak in 2011. Salmonella-tainted eggs in 2010, E. coli in strawberries in 2011, and listeria in caramel apples last Halloween combined with dozens of others during the last six years, have sickened thousands and killed dozens of people.

The brand reputation impact from the incidents at Peanut Corporation of America and Jensen Farms was terminal—both companies went bankrupt. The effect on Blue Bell, while likely not fatal, is expected by industry experts to be substantial and include loss of revenue and market share. The company has already announced plans to lay off more than 1,000 workers as a result of the recall.

In addition, growers saw cantaloupe consumption take a nosedive after the Jensen Farms listeria outbreak, which was one of the worst foodborne illness outbreaks in U.S. history in terms of number of deaths. They are only now seeing sales levels return to those before the incident. And because the farm itself went out of business, personal injury lawyers went after the companies that sold the disease-ridden cantaloupes—the retailers. By virtue of last year’s out-of-court settlement by Walmart on the Jensen Farms lawsuit, both suppliers and retailers are now responsible for everything they sell.

Enter the Food Safety Modernization Act, signed in 2011 and about to begin finalization in August. FSMA mandates that retailers and suppliers have documentation that verifies their supply chain’s regulatory compliance is readily accessible for government inspection. Add these records to the business relationship records that retailers and suppliers should already be maintaining (including indemnifications and certificates of insurance that help manage brand risk), and you’d think our risk of foodborne illness is about be eradicated.

Although FSMA represents the most sweeping change to our food safety laws in the last 70 years, it may not have the greatest impact where the supply chain is most vulnerable. Today the largest suppliers that sell the majority of our food have very sophisticated systems to ensure safe food production and transportation. This group will have the easiest path to compliance with FSMA, and they most likely already hold themselves to a higher standard. It’s actually the smaller suppliers, which likely do not have the available resources or sophistication to comply with FSMA requirements, that will be exempt from certain documentation under FSMA based on their size. This group of suppliers is growing rapidly to meet consumer desire for fresh food that is locally grown and produced. Unfortunately for them, it’s only a matter of time before wholesalers and retailers decide that the risk is too great to continue to do business with these small suppliers.

The good news is that technology exists that can help small suppliers reduce risk in their extended supply chains. Affordable, interoperable systems have been developed to address the market need for receiving, storing, sharing and managing regulatory, audit and insurance documentation. Suppliers of any size can also track products as they move through the supply chain and trace them back in the event of a recall. This move to automation will help all suppliers not only meet the demands of FSMA, but also establish a base for retailer and consumer demands for transparency in the supply chain going forward.

Having a comprehensive food safety system is quickly becoming a competitive advantage. Retailers and consumers are looking for those suppliers that have an unblemished safety record and are transparent about their safety processes, so the time is now for small suppliers to hold themselves to a higher standard than FSMA requires for future business opportunities. The stakes are just too high for retailers and wholesalers to not verify that everything they sell to consumers is produced and transported safely.

Bug Bytes

Tis the Season for Mosquitoes. Take Preventative Action to Protect Your Facility

By Maria Fontanazza
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With the heat of summer quickly upon us, food processors should take measures to keep their facilities free of pests that can both harm workers and lead to contamination.

Memorial Day is the unofficial start of summer, a time when we can look forward to more relaxing days sitting by the pool, just enjoying life. But the season also welcomes the unwelcome: more bugs and other little critters.  It is during this time of year that food processers should be extra vigilant about inspecting their facilities to ensure that pests do not become a problem.

While small in size, mosquitoes can be big in nuisance. Ron Harrison, Ph.D., director of technical services at Orkin, LLC, offers a few steps that companies should take to prepare for the season to both protect workers from potentially serious disease transmission such as West Nile Virus or chikungunya virus, and keep mosquitoes from contaminating a food processing facility.

1.    Inspection. Conduct a thorough survey of the perimeter or outside of your building. Have your pest control professional or entomologist look for the presence of natural breeding sites and how they can be eliminated. For example, if there is standing water, how can it be drained? Can it be moved as opposed to remain standing? Growth regulators can also be used to inhibit the developing larvae.

2.    Secure your building. Make sure all screens are in place and that your heating and air system is in proper working order. Check the pressure of your building. If you have positive air pressure with a door open, it pushes air out; if you have negative air pressure, it sucks air in, so a mosquito or any type of bug could be sitting on the outside and get sucked inside.

3.    Use residual products. Mosquitos can be blown in from long distances. Using good residual products on vegetation and shrubs on the outside of your building can help reduce the population. In addition, make sure any dense landscaping is pruned to reduce the harboring sites where mosquitoes might live.

Harrison adds that the prevalence of mosquitos tends to be worse based on the location of a facility. This is where making sure your building is tightly sealed, from the cracks to the positive air pressure in entranceways, is important. “The biggest reason we struggle is that the building or processing plant is built in a swampy area, which is a haven for bugs,” he says. Other factors, including the color of the building (light-colored buildings) and the presence of excessive lighting, can attract more insects.
 
Now is the time for food processing facility managers to take action and inspect their facility. “Mosquitos are just now starting. In another two or three weeks, it’s going to get serious,” says Harrison. “Preventative activity means that later on in the season when they are bad, your processing plant won’t have problems because you took proactive steps.”

The Accountability Factor in Food Safety Culture

By Maria Fontanazza
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To build an organizational culture that embraces true food safety preventive controls, give employees the autonomy to make critical decisions.

Strengthening food safety culture within a company goes beyond the quality function in raising the banner for food safety: Engagement across an organization, from human resources to maintenance to operations are essential. In a recent Q&A with Food Safety Tech, Laura Nelson, vice president of business development and professional services at Alchemy Systems, discusses how companies can train employees working on the plant floor to help them attain a level of empowerment to take an active, preventative role in food safety, as well as how to engage executive leadership in sharing and evaluating metrics.

Food Safety Tech: How does the accountability of employees play into FSMA implementation?

Laura Nelson: FSMA is going to be additive to what [companies] are doing now in some ways. When you look at FSMA, I think about formalized programs for some companies that may not have a full-blown environmental program that is managed as a preventive control. There’s a lot of training [involved], not only in executing the environmental program, but also in how you maintain your environment to prevent those microbial niches. You start to drill back from the actual protocol of environmental monitoring, and what you do when you receive a positive listeria. How can we start educating employees to be able to recognize the niche? [For example,] is it a cramped pushcart, or damage to [something] holding product where it can’t be properly cleaned? You start educating employees at the level that they can play a more preventative role [in recognizing] they need to take equipment out of commission or send it to maintenance because it can’t be cleaned. This is when we start to see a real change in the culture of a plant. People move beyond these SOPs and requirements to a much more facilitative and educational role to drive the support of some of the FSMA requirements.

The other thing I see is record keeping: There’s a big criticality in maintaining records. People maintain a lot of data now, and there’s a lot of ancillary information included. We just haven’t had the scrutiny on record keeping. The auditors will look through it and find the information they need, but it will be a different [level of] scrutiny when FDA inspectors start to look at the data out there. I think that provides a big opportunity for industry to look at how they maintain records, what they use, and how to capture it. Again, it rolls down to employees—educating them on what is a proper record.

FST: Is facilitating employee awareness and training a challenge faced by more smaller companies versus larger organizations?

Nelson: I think large and small companies face the same challenge, and that is to elevate the knowledge of their employees (they are the eyes and ears) to help them maintain your food safety programs. It goes beyond an SOP on how to clean a piece of equipment or wash their hands. It’s more of understanding the “whys” behind it so they can be line-of-sight. They’re [on the floor] 24/7; they’re the ones who see equipment getting damaged, or drips and leaks. For them to understand and recognize what kind of risk that introduces into a plant [enables them] to raise their hand to prompt some corrective action.

There are food companies out there that are looking to achieve that level of autonomy of giving employees the ability to stop a line because there’s a food safety issue. These are hourly workers that have the autonomy to do that. That’s a huge thing. If you’re able to do that, you’ve far surpassed the basic compliance of any kind of training or education. You’re really looking at an organizational culture that has embraced true food safety preventative controls program.

FST: Food Safety Culture makes the connection between employee behavior and accountability, and establishing metrics. What are your thoughts on Food Safety Culture moving forward?

Nelson: It’s very hard to monitor behaviors. It’s easier to do classroom training and check that box. [It’s the] “how-to”: How do you do that? How do you mature your food safety culture to a point where you get to that autonomy point? We know that you need to go beyond letting employees read SOPs and sign-in [sheets], and say they understand it and move on. You have to move beyond classroom training where you’re giving employees what they need to know and telling them the requirements. You have to connect those behaviors, and then monitor and observe those behaviors, and validate that you’re executing on them. Then it’s applied onto the plant floor.

Embrace the culture of helping each other. Once you’ve achieved this: if your employees are executing when you’re not looking, that’s culture. It’s integrated and something that people embrace.

We did some research on the topic and developed an iPad coaching tool that allows people to systematically gather the data, to capture and automate it. We found that supervisors appreciated it because they had something that was clear and gives them dialogue on what to say in the event that something was missed.

FST: Where should companies focus when training and educating employees to reach a stage of empowerment?

Nelson: The training needs to be at the [appropriate] education level; it needs to be in the language they that understand. [For example,] companies may be able to do a lot more with pictures to accommodate non-English speaking folks in their plant.

Employees need to be challenged and quizzed to make sure they understand the information. The training itself needs to be tied to metrics:  What are you trying to achieve as a plant and therefore [need] to train people on? This should be tied into factors such as customer complaints, quality issues, and what has a direct impact on what employees are doing or not doing, as this [leads to] much more accountability. That’s where the role of the frontline supervisor is critical. That position is absolutely key to the success of driving food safety program compliance. We have to recognize that our frontline supervisors need the skills to motivate employees and communicate effectively with them, including discussing the challenges in conflict resolution.

Elevating food safety so employees as are aware. Awareness programs have a documented advance to people trying to drive specific requirements. We’ve seen a lot of people develop awareness programs around food safety and provide the focus in the plant on key elements that people struggle with. That way, they’re able to have multiple touch points (posters, digital signage, huddle guides). This is absolutely key as we move forward: not just training, but ongoing awareness.

FST: How can companies further educate management to understand the value of food safety culture and reach a point of alignment?

Nelson: There is and can be a pretty big disconnect between executive leadership and what is going on related to food safety. When you talk about the collaboration of the team and those within the plant, you have to include your executive management team. They should understand the different activities and efforts that go into driving a food safety program in a plant. When talking about metrics and evaluating effectiveness, that data should be shared with the executive team on a routine basis so that everyone is clear on what is happening in the plant as well as the results. If the results aren’t where we want them to be, and we’re not in a continuous improvement mode, then what is it going to take to get there? That dialogue should be had.

If you don’t continue to educate your executive team on what issues you’re seeing, then you start creating a divide within the organization. That’s part of what stems from people struggling with a lack of resources and time; this disproportionate disconnect is between other activities within a plant. Communication needs to be routine; people need to be held accountable for metrics so that you’re actually tracking to them. And if you need [more] resources, it’s the perfect way to start building a case for getting additional sales, technology, programs or procedures.

Food Safety Tech’s Food Safety Culture Series

Embed Food Safety Culture. There’s No On/Off Switch

Food Safety Culture: Measure What You Treasure

Randy Fields, Repositrak
FST Soapbox

The Silver Lining of FSMA Compliance: Leverage the Cloud to Mitigate Risk

By Randy Fields
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Randy Fields, Repositrak

It may seem counter-intuitive that any government regulation could generate an opportunity for food industry manufacturers, processors and marketers. But that is exactly the case with the Food Safety Modernization Act (FSMA). Manufacturers as well as your suppliers and customers need to invest in and change some business practices to comply with FSMA regulations, and doing so will enable them to bolster other processes and technologies to further cut costs and help mitigate risks not directly associated with food safety.

FSMA requires food manufacturers and your trading partners (both upstream and downstream) to have the documentation for regulatory compliance readily accessible for government inspection, with specific records required for companies that transport food or are deemed to be the procurer of foreign products. When you add these records to the business relationship records that food manufacturers, your suppliers and customers should already be maintaining (such as indemnifications and certificates of insurance that help manage brand risk), the databases start to become very large, very quickly.

The easy part of FSMA compliance for food manufacturers is with your largest customers and suppliers, because they likely have the processes and technologies in place to ensure both companies have the proper documentation. It’s really the group of smaller customers and ingredient providers, which can represent thousands of companies, that may not have the sophistication to supply the data points required under the law. Collecting and managing the information from these firms can be costly and labor intensive.

The good news is that cloud-based technology now exists to help all trading partners in the food supply chain meet FSMA requirements while working to prevent outbreaks and quickly limiting situations when they occur. This technology goes beyond just storing digital copies of documents—it helps to manage compliance with exception-based alerts for expired, missing or inaccurate records. It can also be the basis of an approval process for new vendors that incorporate record compliance. By linking and automating the management of compliance documentation and new vendor approvals, companies save time and allow for redeployment of resources to more productive activities. 

If you are serious about reducing brand risk, linking compliance management data with your purchase order system will swiftly and effectively accomplish that goal. Holding a purchase order for a non-compliant vendor protects the retailer, manufacturers and the consumer, and communicates a commitment to food safety within the entire supply chain. 

So, complying with government regulations such as FSMA doesn’t have to represent a significant one-time investment in technology and ongoing upkeep. Look to cloud-based technology with an eye for streamlining current processes, reducing overhead and supporting new customer or regulatory requirements.  And, being proactive to ensure the safety of your company and your customers will put you in a position to sell more and grow your market share. 

Unleashing the power of the cloud on Food Safety and Food Quality

By Food Safety Tech Staff
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SafetyChain’s FSQA Tech Talk conversation continues next week with a discussion on why cloud and mobile technologies are becoming a game changer for food safety and quality assurance (FSQA).

As part of an ongoing series that focuses on how technology is being leveraged to solve FSQA execution challenges, the next FSQA Tech Talk session’s special guest speaker will be Michele Eddy, Corporate QA Manager with UniSea.  Eddy will be sharing her experience and insight as to how realtime FSQA data, which is  available, anywhere, and at anytime, is helping to provide sales with immediate quality gradings, better manage HACCP, CAPA, and direct observations for UniSea’s pillars of sanitation,  and how the cloud is making it easier for participants in their supply chain to work together.  Eddy will also discuss use and employee adoption of mobile devices.

The session will start with SafetyChain’s Director of Technical Solutions who will discuss key benefits of the cloud on FSQA, including the ability to have realtime data proactively pushed out and acted upon,  as well as how cloud and mobile devices support FSQA transparency and visibility across the value chain. Also discussed will be common cloud misperceptions including security and employee adoption.

The speakers will be taking questions live from the audience, and FSQA attendees are encouraged to bring their IT folks to participate. Attendees who would like to see what the cloud and mobile FSQA apps look like in action, are invited to stay online after the Tech Talk for a 15 minute demo of SafetyChain’s cloud and mobile solutions. The session is being held on Tuesday, May 19 at 10:00 am PDT, and those interested in attending can visit here for more information and to register.

The FSQA Tech Talks are a part of SafetyChain’s 2015 FSQA Technology Series: “Enabling Technologies – The Food Safety & Quality Assurance Game Changer” – which includes Leadership Forums, FSQA Tech Talks and Executive Briefs. Jill Bender, SafetyChain Vice President of Marketing Communications, said, “SafetyChain has been very proactive these past several years in educating industry on key FSQA challenges such as FSMA, GFSI, cost of quality and more. Input from the thousands of people who have attended our webinar forums was that they’d also like to learn more about how their peer companies are leveraging technology to execute on these challenges – and so the 2015 FSQA Technology Series was born!” “So far more than 1,500 hundred FSQA and food company IT folks have participated in the series, and we’re very excited to continue with fabulous speakers such as Michele Eddy,” Bender continued.

To learn more about SafetyChain’s FSQA Technology series visit www.safetychain.com/2015techseries.

Upcoming FSQA Tech Talks Include:
June 23: Harnessing Cost of Quality
July 21: Conquering HACCP, HARPC and Food Safety Plan Management
Participants of this series need only sign-up once and will automatically receive notice of the next topic and login/call information.  Register here for this complimentary series.

Maria Fontanazza, Editor-in-Chief, Innovative Publishing Co. LLC
From the Editor’s Desk

Translating the Talk into Action

By Maria Fontanazza
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Maria Fontanazza, Editor-in-Chief, Innovative Publishing Co. LLC

With a little less than two months under my belt as an editor in the food safety industry, I have already started to become a bad dinner date and my hands beg for mercy as a result of my newfound obsession with soap and water.

Quirks aside, I am seeing some common threads in this industry, although they are themes we see in any highly regulated industry. Partnerships. Collaboration. Transparency. Alignment. Accountability. Now more than ever, these words mean something. FSMA has forced the issue of food safety to the forefront. Yet, we’ve barely begun and I’m already hearing the phrase “FSMA Fatigue”.

For the folks who have been involved in preparing for FSMA from the start, they probably are a bit fatigued. There have been many meetings, and there’s been a lot of talking surrounding what’s going to happen, what needs to be done, and what challenges we’ll face (in many cases, together). But let’s not forget that not everyone is as well versed on the nuances of the regulation. I admit, I am raising my hand here… for now.

Now let’s back up a couple of sentences. “There’s been a lot of talk…” Yes, there has been. While these are enthusiastic discussions about what we as regulators, food processors, retailers, suppliers, scientists and everyone in between should be anticipating with FSMA rules and the consequent implementation, HOW are we going to navigate this new frontier?

Let’s start this conversation now.

You’ll see a lot of changes to Food Safety Tech this year. We’ve already started the information exchange with industry stakeholders about how we’re going to work together to get through FSMA implementation and the tools we need to arm our audience with to help them along this journey. We also just announced our Call for Abstracts for the Food Safety Consortium Conference in November.  The Consortium will bring together leaders and regulators in this industry and facilitate a forum for that candid “how” discussion. Food Safety Culture will receive strong attention, and key players will be presenting a case history of how to apply metrics to food safety culture within organizations.

I’m excited to join this industry, and thank you to those who have already extended a warm welcome. And for the many who I have yet to meet, please drop me a note as you encounter challenges or have ideas about critical food safety topics. Our job at Food Safety Tech is to provide a platform through which we can enable a constructive dialogue about overcoming challenges, working together effectively, and navigating this journey into the future of food safety.

Maria Fontanazza
Editor-in-Chief

Prepare Your Food Safety Plan for the Preventive Controls Rule

By Maria Fontanazza
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As FDA prepares to issue its next final FSMA rule, Preventive Controls for Human Food, companies should already be laying the groundwork for training staff.

With the August 31 deadline for the Preventive Controls for Human Food rule only months away, careful attention must be paid to training, metrics and collaboration between larger and smaller players to prepare for implementation.

Training surrounds all aspects of a food safety plan, from understanding validation and verification to proper recordkeeping. “Regardless of what happens, training is critical and imperative,” said Donna Garren, Ph.D., American Frozen Food Institute, at the Food Safety Summit last week in Baltimore. “FDA is measuring food safety culture in an operation, and training must be ongoing.”  Garren pointed to the FDA-funded Food Safety Preventive Control Alliance (FSPCA), which was established to develop standardized curriculum and help companies, especially those small and mid-sized, with training programs to meet requirements of the preventive controls regulation. The FSPCA curriculum is fairly broad and includes content that addresses an overview of food safety plans and GMPs, preventive controls related to allergens, sanitation, and suppliers, recall plans and record-keeping procedures. FSPCA has planned its pilot sessions for April, May and June of this year, with a train-the-trainer course planned for the fall.

Formed in January, the FSMA training workgroup has been working to develop training curriculum specifically for regulators on how to evaluate a facility against the preventive controls requirements. According to Priya Rathnam, supervisory consumer safety officer, Division of Enforcement/Office of Compliance at CFSAN/FDA, the agency plans to take a staggered approach to training based on deadlines, beginning with larger companies, as it is not practical to train all safety staff at once.

FDA’s Preventive Controls Phase 2 Workgroup is developing a metrics plan to measure progress (specifically measures that directly tie in with public health outcomes) and track trends, making adjustments as necessary. The agency plans to issue a guidance document to help industry and food and feed safety staff identify significant hazards and implement preventive control strategies. An internal technical assistance network is also planned to assist in consistent implementation in the field.

Start the journey now

While many in the industry may suffer from “FSMA fatigue”, discussing the implications of FSMA day in and day out, a lot of education and outreach still remains. Not everyone within an organization is aware of the intricacies of the regulation. “[We] need to make sure others have the same level of insight that we do,” said Tim Jackson, Ph.D., director of food safety at Nestlé North America.  In addition, the bigger industry players need to work with smaller suppliers and manufacturers that don’t have the resources.

When developing an implementation approach, a company should standardize an internal approach now, rather than wait until the rule comes out in August. This begins with establishing a FSMA team. Jackson advises that this specialized team perform a detailed review of the preventive controls rule requirements and conduct a face-to-face workshop to confirm a rollout strategy and action plan. “We’re looking at our own HACCP plan,” Jackson says of Nestle, adding that they are reviewing validation of control measures and the company’s documentation system, challenging whether it’s “good enough,” and enhancing its early warning system.