Tag Archives: Supply Chain

PattyMcDermott, ThermoFisher Scientific
In the Food Lab

How Digital Solutions Support Supply Chain Transparency and Traceability

By Patricia McDermott
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PattyMcDermott, ThermoFisher Scientific

Ensuring the safety and authenticity of food is a key responsibility of growers, producers, manufacturers and suppliers. With so many partners involved in the journey from farm to fork, tracking chain of custody data and maintaining a clear, unbroken record are essential to safeguard the quality and provenance of products. However, without proper systems to maintain transparent supply chain audit trails, businesses operating within the food industry run the risk of being responsible for adverse events that could result in health, economic or even legal consequences.

One of the biggest challenges associated with maintaining a clear chain of custody is the need to monitor the flow of raw materials, ingredients and products across increasingly global distribution networks. To successfully track food products throughout the value chain, information on product movements and quality control data must be accessible to those who need it. These systems must also remain compliant with the latest regulations, as well as ensure stakeholders can achieve the highest levels of productivity to meet consumer demand.

For players within the food supply chain to achieve transparent processes and complete traceability, robust information exchange mechanisms and integrated data management systems are key. The latest digital solutions are ensuring the integrity of supply networks by capturing and making available data from any stage of this journey for regulatory or product quality assurance purposes.

Food Safety: A Global Responsibility

The global nature of modern supply networks can make ensuring the safety and quality of food challenging. From honey and juice to yogurt and cheese, tracking the lifecycle of food products is essential to combat food fraud and adulteration, as well as safeguard consumers from harmful food contaminants, such as pesticides and bacteria. Unscrupulous behavior from businesses operating within the supply chain can, for example, cause consumers to purchase products that are not what they claim to be, and even put customers’ health at risk through exposure to potentially unsafe batches.

Given the global expansion of the food supply chain, regulatory bodies are putting increased focus on ensuring that products that pass through multiple channels and regions comply with the same regulations. By focusing on enforcing standards through audits and reviews, it becomes possible to prevent and therefore reduce the potential for adverse events occurring.1 As a result, voluntary standards such as the ISO 22000 guidelines, and mandatory regulations such as FSMA and EU 178/2002, have been put in place to set clear benchmarks for stakeholders’ responsibilities and better enforce food quality and safety.

Regulations such as these require extensive record keeping, transparent audit trails and accountability for all processes. While end-to-end monitoring of one process may be relatively straightforward, ensuring visibility for every process within a complex food supply network can quickly become an overwhelming task. In order to achieve regulatory compliance across all aspects of a supply chain, businesses must be able to integrate their data management systems to achieve full oversight. Moreover, with effective data management tools in place, businesses can organize and incorporate data from all aspects of a food product lifecycle in a compliant manner, enabling them to expand globally.

Integrating Digital Solutions for Better Outcomes

To preserve consumer confidence and brand integrity, businesses operating within the food industry are recognizing the need for automated infrastructures that can manage data, streamline processes, and ensure traceability and accountability for every product. By integrating all monitoring processes into a single system and enabling access to this information via the cloud, the latest digital data management platforms are working to alleviate the challenges associated with operating global supply networks.

Manually organizing inventory management, standard operating procedure (SOP) use, and product traceability can be difficult and time-consuming, especially if operations are on a global scale. Setting up automated processes to manage fail points using a laboratory information management system (LIMS), where they can be itemized and protocols established for potential hazards and preventive measures, can boost speed and efficiency while ensuring the highest levels of data integrity.

Routine food safety testing requires the consistent replenishment of supplies, and the failure to keep on top of inventory use can cause operations to grind to an unexpected stop. Automatic supply level monitoring and automated ordering using a LIMS can eliminate inventory fail points and help to ensure uninterrupted productivity. Furthermore, introducing electronic SOPs as part of a LIMS can define and outline workflows to prevent unintended errors and ensure reliability. Additionally, tracking and logging products using barcode readers throughout their lifecycle gives stakeholders confidence in the products they handle, and can simplify quality control and regulatory review processes.

With the need to monitor so many processes across the food supply chain, there are large volumes of instrument data, workflows and records that must be maintained. Leveraging a LIMS to collect and manage disparate data from all aspects of every process can help stakeholders to streamline workflows. From evaluating potential hazards to eliminating possible issues, having procedures tracked automatically not only transforms processes, but also simplifies quality assessment.

The latest LIMS are able to aggregate all of this data in a single cloud-based system, making this information available at the tap of a tablet or smartphone. Integrating a LIMS with laboratory equipment across food safety testing protocols allows for automated data transfer and increased lab efficiency. Data can be captured from laboratory equipment using a connected scientific data management system (SDMS), which is generated using the approved methods and SOPs available from a laboratory execution system (LES). Interfacing to each instrument using the LES ensures there are no input or copying errors. Subsequently, as process results are entered into the system, any out of specification parameters can be flagged and reported automatically.

The value of an LES within a LIMS can be seen in food safety labs where global demand drives time to market and thus the need for high production efficiency. By giving lab managers control over method and protocol management from any location, the actions of users can be easily recalled for performance monitoring and accountability purposes. And with protocols, regulations and corrective actions defined through the LIMS, labs can achieve faster and more effective decision-making.

Digital solutions such as LIMS are enabling food safety scientists to perform analyses based on readily available SOPs using LES platforms, collect and store data in its original form using an SDMS, and evaluate how the data is being collected, transferred, stored and accessed from a centralized, cloud-based LIMS. These integrated digital solutions offer comprehensive support for the organization of chain of custody data, ensuring full traceability and compliance, and protecting consumer safety and food integrity.

Improved Traceability for Regulatory Compliance

Current regulations are enforcing the quality and safety of food products using well-defined standards for laboratory processes, ensuring the transparency of data handling processes, from raw materials to packaged products. ISO 22000 sets recommendations for food safety management systems and requires businesses to implement hazard analysis and critical control points (HACCP) to ensure the highest levels of quality control and assurance throughout the product lifecycle.

Regulations such as EU 178/2002 and FSMA include mandatory requirements for the traceability of food, feed and any other food-related substance or animal through identification and food tracking programs. Given the unfortunate growth of food fraud, traceability and authentication are becoming increasingly important. The latest regulations are helping the food industry to maintain optimal production practices to safeguard public health, maintain consumer confidence and preserve brand integrity.

Systems that are fully harmonized with these guidelines can be used to maintain data in organized archives, simplify audit trail recording for proof of compliance, and enable easy-access for users to review data. The latest LIMS can support HACCP compliance by automatically alerting users to deviations in expected processing parameters. In this way, issues can be quickly identified, and corrective action can be taken to prevent potentially dangerous products from reaching the consumer.

Digital lab and data management solutions are helping food supply chain stakeholders to simplify tracking, improve transparency and ensure the highest levels of accountability to protect both product authenticity and consumer safety. The integration and implementation of these systems helps to fulfill production demands as well as meet future challenges, allowing the food industry to expand and develop services and checks with the growing global market. Moreover, the potential for food fraud or adulteration is greatly minimized, giving consumers additional confidence in the products they purchase.

Reference

  1. Charlebois, S. Sterling, B. Haratifar, S. and Naing, S.K. (2014). “Comparison of Global Food Traceability Regulations and Requirements,” Compr. Rev. Food Sci. Food Saf., vol. 13, no. 5, pp. 1104–1123.
Mike Robach

The Future of Food Safety: A Q&A with Cargill’s Mike Robach

By Mahni Ghorashi
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Mike Robach

Continuing on our journey to bring you the successes, best practices, challenges and accomplishments from the very best in this industry, this month I had the pleasure of interviewing Mike Robach, vice president, corporate food safety, quality & regulatory for Cargill. Mike joined Cargill in January 2004 to lead the company’s corporate food safety and regulatory affairs programs. In this role, he helps partners innovate and manage risk so they can feel empowered to nourish the world

Mike Robach
Mike Robach, vice president, corporate food safety, quality & regulatory for Cargill

Mike has also worked closely with the USDA and FDA regarding food safety policy, HACCP, and regulatory reform based on science. He serves as chairman of the board of directors of the Global Food Safety Initiative (GFSI) and is a member of the Institute of Food Technologists and the International Association of Food Protection, among many other organizations dedicated to ensuring safe food and bringing innovative technology into the agricultural industry. He has worked with the World Organization of Animal Health (OIE) and the Food and Agriculture Organization (FAO) on harmonized animal health and food safety standards.

Mahni Ghorashi: What are the biggest risks to our food safety infrastructure in 2018? What’s keeping you up at night?

Mike Robach: The biggest risks I see have to do with supply chain integrity and how companies implement their systems. Too often we do not have line-of-sight to the origin of the commodities and ingredients that make up our products. With global supply networks it’s important to understand where and from whom you are getting your inputs. There is also a need for food safety capacity building throughout the global food system. Many small and medium companies, along with some large companies, do not have the proper training for their employees to manage a food safety program. We also have an issue with constantly changing regulations that are not uniform from country to country, adding risk to our business.

Ghorashi: What are you most excited about? What’s changing in a good way in the food safety sector?

Robach: I am very excited about the application of new technology to our food safety programs. In-line, real-time testing gives an opportunity to manage our processes and make immediate adjustments to assure process control. This allows us to prevent product that is out of control from reaching the marketplace. Blockchain technology gives us the chance to drive greater transparency throughout the supply chain.

Ghorashi: Let’s talk about regulation. How is the implementation of FSMA going? Do you foresee any challenges with the next phase of implementation?

Check out last month’s Q&A with Frank Yiannas of WalmartRobach: I think FSMA implementation is going okay right now. There’s still a long way to go, and I am always concerned about making sure investigators are applying the rules and regulations in a consistent manner. I see the intentional adulteration rule as an upcoming challenge. It is one thing to conduct a vulnerability assessment and adjust your programs based on the results. It’s another to develop and implement a program that will prevent intentional adulteration as you would to reduce or prevent microbiological contamination.

Ghorashi: If you take a look at the homepage of Food Safety News, all you see is recall after recall. Are transparency and technological advancement bringing more risks to light and are things generally trending towards improvement?

Robach: I believe that food safety management programs are constantly improving and that our food is as safe as it has ever been. However, we still have a lot of work to do. At GFSI, we are continually improving our benchmarking requirements and increasing transparency in the process. We have better public health reporting and our ever-improving analytical technology allows us to detect contaminants at lower and lower levels. The industry is working collaboratively to share best practices and promote harmonized food safety management systems throughout the supply chain.

Ghorashi: What is the number one challenge of securing global supply chains for 2018?

Robach: Knowing and understanding the integrated supply chain. Having knowledge and control of the process from origination to consumption would be ideal. We need the implementation of risk-based, harmonized food safety management systems based on the principles of Codex. Assuring the application of these systems along with properly trained employees to implement these programs would be the first step towards a secure, safe global food system.

Ghorashi: How do international trade deals and the stance of the current administration affect the future of food safety policy?

Robach: International trade deals such as the Trans Pacific Partnership and NAFTA can do a lot for the assurance of safe food around the world and within regions. Making sure that food safety provisions are included in these trade deals can drive the implementation of food safety management systems that will ensure safe food for consumers everywhere. These types of deals should allow us to remove technical barriers to trade by basing the requirements on Codex principles and adhering to the WTO SPS agreement.

Ghorashi: What role is blockchain technology playing in food safety? What are the prospects for the future?

Robach: Blockchain has a role to play in driving more transparency across the integrated supply chain. It can allow companies to show consumers where their food comes from. It can also be used to quickly trace back product in the event of a food safety problem. Still, it’s an enabling technology, not a solution.

Ghorashi: What about CRISPR? How is the food industry starting to respond to this technology from both a policy and GMO screening?

Robach: Gene editing holds great promise and many companies are looking at its potential benefits. However, there is always the policy question on whether or not the use of this type of technology should be labeled. I think the food industry has not done enough to promote the use of technology and how food production has improved over the years. We should let consumers know how we apply science to making food safer, more nutritious and more sustainable. At Cargill we have the vision of being the leader in nourishing the world in a safe, responsible and sustainable way.

Ghorashi: What trends are you seeing in food safety processes within food companies? Are they becoming more decentralized? Less? How are they balancing innovation with decades-old food safety practices?

Robach: Through the Global Food Safety Initiative, we have promoted harmonized, risk-based food safety management systems. The GFSI-benchmarked certification programs provide an opportunity for companies to implement consistent food safety programs regardless of where they are in the world. Through the GFSI Global Market Program there’s a tool kit that less sophisticated companies can use as a pathway towards full certification. We are constantly updating the benchmarking requirements to assure they are keeping up with changing science and technology.

Blockchain, Food Safety Supply Chain Conference

Is the Food Industry Ready for Blockchain?

By Maria Fontanazza
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Blockchain, Food Safety Supply Chain Conference

Darin Detwiler will lead a plenary session titled, “Practical Use of Blockchain in Food Safety” at the 2018 Food Safety Consortium | Learn moreOn the heels of the deadly, widespread outbreak of E.coli O157:H7 illnesses linked to romaine lettuce—and 12 years after the infamous spinach outbreak of 2006—the food industry is struggling to find the solution to prevent these outbreaks. “I think it’s indicative that we need to do something different,” said Melanie Nuce, senior vice president, corporate development & innovation at GS1 US, during a panel discussion about blockchain at the 2018 Food Safety Supply Chain conference earlier this month. The panel, led by Darin Detwiler, assistant dean and director, regulatory affairs of food and food industry at Northeastern University, delved into the strengths and weaknesses of blockchain, along with industry readiness and acceptance.

In its most basic form, the technology would allow for the addition of information from every step of the supply chain, from manufacturing to packaging to distribution to retail, and would incorporate elements such as auditing, inspection, batch information, certification of auditors, preventive control plans, HACCP information, and allergen identification.

“Blockchain could be the death of the document.” Simon Batters, Lloyd’s Register

Strengths

The increased demand for transparency and traceability could be one of the biggest drivers for the adoption of blockchain. “[Blockchain] offers us the technology for traceability,” said Simon Batters, vice president of technology solutions at Lloyd’s Register. “It allows us to have an immutable record of a transaction; it won’t solve the food safety conundrum overnight—it’s part of the tool kit that we need.”

The fact that the food supply chain consists of millions of transactions, which could not be tampered with under blockchain, while the data could be used as reference points and for verification—those are strengths. However, Batters pointed out, there should be restrictions on who has permission to write the code and who has access to putting the information into a chain.

The technology would also enable smart contracts whereby shipments wouldn’t be finalized if they didn’t meet the conditions of a supplier, for example. “All parties to a transaction have a view to the entire chain at the same time,” said Nuce. “You have real time visibility. This democratizes that.”

Kathleen Wybourn, director, food safety solutions at DNV GL, calls blockchain “the birth certificate for food.” From a consumer standpoint, it would provide information on a product’s origin—and these days, consumers—especially millennials—are very interested in the story of food from farm to fork.

2018 Food Safety Supply Chain Conference, Blockchain
The blockchain panel, led by Darin Detwiler, Director: Regulatory Affairs of Food and Food Industry, Northeastern University featured (left to right) Kathy Wybourn, Director, Food Safety Solutions, DNV GL; Simon Batters,
Vice President of Technology Solutions, Lloyd’s Register and Melanie Nuce, Senior Vice President, Corporate Development & Innovation, GS1 US.

Weaknesses and Threats

The panel pointed out several areas of improvement (and unknowns that must be answered) before blockchain can be taken to the next level in the food industry.

  • Although the technology could aid in faster transaction times, as the size of the ledger gets larger, and it will become more difficult to manage.
  • Industry involvement: “If you don’t get 100% participation, it’s not going to be successful,” Nuce said. “To have true trace back, everyone has to participate.”
  • Blockchain platforms: Will they be able to interact and share data? What type of blockchain architecture is necessary for this?
  • Poor architecture
  • Need a better grasp on the type of data being used and how it delivers value
  • What impact will it have on the role of certification bodies?
  • Politics and the competitive element: Will certain parties seek to control this space?
  • Will the culture shift be a roadblock?
Melanie Nuce, GS1 US
Read Melanie Nuce’s column, Blockchain: Separating Fact from Fiction

Final Thoughts from the Panel

“Nobody can really tell where this is going to go in the future. I think it’s going to be part of food safety in their roles in one shape or form…I think we’ll see more of where this is headed within the next 12–18 months.” – Kathy Wybourn

“I think it’s going to be a fast-moving dynamic area.”– Simon Batters, who suggested that the organizations that embrace blockchain early may be the ones who show the way

“From an information/standards perspective, you have to have foundational business processes to support any type of technology. That’s what we’ve learned through the pilots.” – Melanie Nuce

“It’s not going to make a company any more ethical… a lot of what we need already exists out there; blockchain is just a tool out there. I keep warning people that this is not the only solution.” – Darin Detwiler

2018 Food Safety Supply Chain Conference, Blockchain

Beyond Supply Chain Trends: Blockchain, FSMA, Food Fraud, Audits and More

By Maria Fontanazza
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2018 Food Safety Supply Chain Conference, Blockchain
Rick Biros, Priya Rathnam, and Andrew Seaborn, 2018 Food Safety Supply Chain Conference
Priya Rathnam (middle) pictured with Rick Biros, president of Innovative Publishing (left) and Andrew Seaborn Supervisory Consumer Safety Officer, Division of Import Operations, ORA, FDA

How well do you know your suppliers? Can you trust your supplier’s suppliers? What kind of technology are you using to assess and ensure your suppliers are in compliance with regulatory requirements? These are common questions food companies must ask themselves on a regular basis. These and more were addressed at the 2018 Food Safety Supply Chain Conference, held last week at USP in Rockville, MD. Stay tuned for coverage of the event in upcoming articles. In the meantime, here are some top insights shared by FDA and others in industry.

“We’ve issued a limited number of warning letters (two), and they were due to really egregious issues. Where there were previously warning letters issued, we’re seeing a lot more ‘regulatory meetings’.” – Priya Rathnam, Supervisory Consumer Safety Officer, CFSAN, on FDA’s enforcement this fiscal year.

Criteria for FSMA auditors also includes the “soft skills”, aka ISO 19011, auditor personal attributes. –Josh Grauso, Senior Manager, Food Safety & Quality System Audits, UL

Fabien Robert, Nestle 2018 Food Safety Supply Chain Conference
Food fraud costs the industry up to $15 billion annually. – Fabien Robert, Ph.D., Director, Nestle Zone America

It’s concerning that so many QA managers (and other pros) today don’t know extent of risk assessment they need to carry out. – Chris Domenico, Safefood360, Territory Manager for North America

“Blockchain is more than a buzzword at the moment.”- Simon Batters, Vice President of Technology Solutions, Lloyd’s Register

2018 Food Safety Supply Chain Conference, Blockchain
A dynamic panel about blockchain, led by Darin Detwiler, Director: Regulatory Affairs of Food and Food Industry, Northeastern University featured (left to right) Kathy Wybourn, Director, Food Safety Solutions, DNV Business Assurance; Simon Batters,Vice President of Technology Solutions, Lloyd’s Register and Melanie Nuce, Senior Vice President, Corporate Development & Innovation, GS1 US.

Sometimes food safety doesn’t win; sometimes you need the business acumen to show that implementing supply chain efficiencies will create the win. – Gina Kramer, Executive Director, Savour Food Safety International

Bryan Cohn, 2018 Food Safety Supply Chain Conference
Building a robust & smart supply chain = reduce food miles, shrink carbon footprint, and save food waste to increase revenue/acre. – Bryan Cohn, Vice President of Operations, Seal the Seasons

The FSMA Sanitary transportation rule is not as straightforward as you think. We need more training. – Cathy Crawford, President, HACCP Consulting Group

FSMA

FDA Issues Draft Guidance on Supply Chain Program for PC Animal Food

By Food Safety Tech Staff
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FSMA

Under the FSMA Preventive Controls Animal Food rule, certain animal food manufacturers that receive raw materials and ingredients must develop and implement a risk-based supply chain program. This is required if the facility determines that a supply-chain-applied control is the appropriate preventive control for a hazard of an incoming ingredient. In order to better help animal food facilities meet these requirements, the FDA released a draft guidance, “Guidance for Industry #246: Hazard Analysis and Risk-Based Preventive Controls for Foods for Animals: Supply-Chain Program”.

According to an agency news release, the draft guidance will help facilities in the following areas:

  • “Determine whether they need a supply-chain program;
  • Identify and implement the appropriate supply-chain program activities required to approve their suppliers and verify their supplier is controlling the hazard in raw materials or other ingredients;
  • Establish frequency of supplier verification activities;
  • Meet documentation and recordkeeping requirements; and
  • Recognize situations that necessitate or allow for flexibility or different supplier verification activities.”

In addition, the document offers clarification for receiving facilities that are animal food importers and subject to the supply-chain program requirements of the FSVP rule.

The FDA is accepting public comments on the draft for the next 180 days.

Deirdre Schlunegger, Stop Foodborne Illness
Food Safety Culture Club

Educate Consumers about Food Safety Technology

By Deirdre Schlunegger
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Deirdre Schlunegger, Stop Foodborne Illness

It seems the world has gone truly global. Whether it’s using your debit card instead of having to change currency, or having great translation capabilities at our fingertips thanks to sophisticated algorithms made available to everyone, or even being able to see and talk through one portable device with friends in Spain while texting with a friend in Japan on another! Global food safety is another area where tools and technology are constantly evolving to make our lives easier, better, and safer. In the United States, FSMA is addressing this phenomenon.

Almost daily, I find myself reading about new inventions and applications that promise to, not only safely deliver food from across the globe, but also accurately track the steps food takes to get to consumers. Yet, outbreaks, recalls, and traceability issues continue to occur. Whole genome sequencing (WGS) is but one of the technologies being applied to food safety while improving tracking capabilities and changing ideas about accountability.

At Stop Foodborne Illness, we encourage more public dialog to, and education among, consumers regarding advances in food safety technology, including traceability. Consumers need to know that although the struggle with outbreaks is still very real, there is continuous research and significant improvement being made in the effort to keep the food supply safe. I wonder sometimes if there should be a one-stop food safety technology website where consumers could go learn more about how food is grown, processed, transported, and tracked, while listing recent advances, and what is next to come in food safety technology.

We believe there is a great need for consumers to be educated about, and feel confident in, the security in their food supply. Being able to eat healthy food without the fear of illness is imperative. As advanced technology brings a reduction in foodborne outbreaks and recalls, trust will build and grow. It’s a circular process. Sharing what we know with the public advances food science and technology, instilling confidence along the way.

Megan Nichols
FST Soapbox

5 Ways to Manage Risk in the Global Food Supply Chain

By Megan Ray Nichols
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Megan Nichols

In 2017, the cost to import food, which has long been fairly predictable, rose by 6% over the previous year—and the number of possible risk factors has risen right alongside the higher price tag. There are several steps you can take to position yourself as an industry leader and manage risk simultaneously. First, though, it makes sense to better understand what’s at stake.

Why Take Steps to Reduce Risk?

Food has never been a more global market than it is today, and those who operate in the food supply chain are bound by the public’s trust in spoken and unspoken ways. Customers are used to taking for granted that they can walk into a supermarket and walk out with ethically sourced fish and eggs free from E. coli worries.

Not every food product is, or can be, a global one. However, some of these domestic risk factors scale up, just as our businesses do. When the food supply chain crosses borders of any kind, the familiar health and food safety risks are joined by several others:

  • Product mislabeling
  • Unplanned-for natural disasters
  • Spoilage due to any number of unforeseen circumstances
  • Damage while in transit
  • Unpredictable politics and shifts in regulations

A food company’s supply chain can be the weakest link in their food safety program. Learn more at the Food Safety Supply Chain Conference | June 12–13 | Rockville, MDIn all honesty, no list will ever encompass the scope of the risk you take on as part of the global food supply chain. That’s not to say you can’t take steps to reduce your risk—sometimes several types of risk at once—as your operation grows. The following is a look at several practical suggestions, some of them more time-intensive and perhaps cost-prohibitive than others, but all worth a look as the world grapples with globalization in the food industry.

1. Don’t Take Company Culture or Employee Training for Granted

Working safely and conscientiously in a particular trade is not knowledge we’re born with. When you consider the fact that at some level every food product we bring into our homes was handled at one point by another human being, you get a sense of the role proper training and a healthy culture can play in the safety we expect of our food.

Among recently surveyed manufacturers in the global food space, 77% of them said globalization itself was a source of risk. It’s easy to see why. In 2015, a relatively small—though still deadly—Listeria outbreak was traced to just a few Blue Bell Ice Cream factories. The company was almost ruined by the three deaths, the illnesses and the nearly crushing reputational damage.

Some momentary lapse of judgment at one or perhaps two factories almost killed this company. Now scale this type of risk up to the global level and think about the possible worst-case scenarios.

We’ll talk more in a moment about ways to introduce transparency and traceability to the food supply chain, but this is a reminder of the stakes. Mindfulness and conscientiousness in the work we do— not to mention well-rested and satisfied workers—are just as vitally important to look after as profitability.

2. Use Predictive Sales Forecasts and Intelligent Logistics to Avoid Spoilage

Unnecessary food waste and spoilage emerged as a mainstream issue in recent years all across the globe. For example, citizens in the EU are forced to discard some 89 million tons of food each year due to overstocking, poor quality control and a lack of attention paid to consumer trends. The United States throws out 35 million tons of food for the same reasons—a problem that, billed collectively, carries a price tag of $165 billion each year in the United States alone.

The solution has arrived in the form of predictive analytics and more intelligent warehouse and inventory management systems. Domestic and global supply chain partners alike now have access to, in some cases, highly customizable software systems that can provide vital data, such as:

  • Ideal stock levels for perishable items
  • Constant checks on incoming versus outgoing products
  • Intelligent insights into customer behavior patterns and near-future buying patterns

These types of data are highly actionable. They don’t just shield you from monetary risks by cutting down on waste— they can also protect you from public health risks by ensuring spoiled products never make it as far as store shelves.

3. Take Your Packaging More Seriously

Many of us don’t give packaging a second thought. So long as it’s easy to get into, eye-catching and protects the product long enough for the consumer to get their hands on it, it’s good enough — right? Not quite. When manufacturers think about packaging as merely a branding matter rather than as a safety check, the price is sometimes human health and lives.

One obvious solution to make sure your products can travel as far as they need to is to invest in vacuum packaging, even for small-scale operations. Compressed air equipment is a highly affordable way to accomplish this. The USDA and CDC provide guidelines on modified atmosphere packaging (MAP) and controlled atmosphere packaging (CAP).

Packaging material requirements are a global concern as well as a domestic one. The EU provides guidelines for packaging materials that are detailed down to the type of ink used. Knowing about the laws in your sales territories and staying aware of new breakthroughs in material sciences can help you remain in compliance and ahead of the game.

In a global supply chain, high-quality packaging serves not just as a risk mitigator, but also as a possible value proposition for your customers. Having your brand stand out as an example of high-quality products in thoughtful, health-conscious packaging could put you in a unique position.

4. Stay Abreast of Changing Regulations

American politics might be volatile, but one thing that isn’t likely to change is that consumers tend to look toward institutions like the FDA to provide updated guidelines and to pursue strong, consumer-friendly legislation. That means compliance isn’t always a choice, but it also means you have the opportunity to anticipate change and mitigate risks faster than your peers.

A recent example is FSMA. It’s had a long rollout, with plenty of advance warning for the industries it touches, but now most of its rules have reached the implementation stage. This lead time has been advantageous given the scope of the anticipated laws because it’s given food processing companies time to prepare for compliance. In fact, globalization lies at the very heart of it.

FSMA will be challenging at times to enforce, but its ultimate goal is to hold domestic and foreign companies in the global food supply chain responsible for a common set of guidelines and best practices.

What does this mean? It means you have yet another opportunity to establish yourself as an industry leader. The intentions of FSMA are to make every part of the supply chain more agile and better able to respond to emerging health concerns and other sources of risk as they unfold.

5. Use Data to Build Greater Transparency

There has perhaps never been a more important time to take transparency seriously in the global food supply chain. As of this writing, a historically significant outbreak of E. coli among romaine lettuce products is closing in on an “all clear” from the CDC after two difficult months. By the time you read this article it’s entirely possible another outbreak of a different kind might be underway or that some product or another has found itself under a recall. The possibility of reputational damage is greater than ever.

The good news is, even when the unfortunate happens, it’s possible to greatly reduce risk to your brand and your customers’ health. However, you need the tools to help you move quickly in tracing the problem.

Some digital technologies of a more physical nature, such as QR codes or RFID chips, can elevate your supply chain transparency and tamp down risk even further by allowing far more granular traceability for your products as they move about. In some high-profile examples, we’re seeing this concept taken to a logical, if slightly extreme, endpoint: Edible QR codes on restaurant food that contain a full history of the meal’s constituent ingredients.

Even if you don’t take your own efforts this far, this level of traceability can help you react far more quickly to emerging situations such as recalls. You’ll be able to isolate shipments with greater ease and trace contaminated products back to their sources. Also, as The Guardian points out, this technology delivers ethical and perhaps legal peace of mind by assuring you that your partners are trading in ethically sourced goods.

Vigilance and Technology in the Food Industry

The stakes in the food industry are high, as we’ve seen. However, with the right combination of a cultural approach to safety, a mindfulness of changing regulations and the sensible application of technology so you can act on the data you’re gathering, you’ll be in a prime position for global success in this quickly changing field.

Audit

First Audit Stakeholders Meeting to Take Place at Food Safety Supply Chain Conference

By Food Safety Tech Staff
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Audit

The Association for Food Safety Auditing Professionals (AFSAP) announces the selection of the Food Safety Supply Chain Conference as the site for the first Audit Stakeholders meeting on June 13 in Rockville, MD. This historic event will bring together FDA, accreditation bodies (ABs), certification bodies (CBs) and other interested parties to outline the requirements for FDA’s Accredited Certification to better understand the AB/CB roles in FSMA’s use of audits to protect the U.S. food supply.

There are two objectives for this meeting: First, the gaps in the current program must be explained so that all understand the challenges ahead. Second, and even more critical, will be to explore solutions such as creating a Voluntary Scheme Owner that will address those gaps.

Patricia Wester, PA Wester Consulting
Patricia Wester, AFSAP founder, will lead the groundbreaking audit panel at the 2018 Food Safety Supply Chain conference.

AFSAP’s founder, Patricia Wester, spearheaded the meeting to address critical questions regarding implementation of FDA’s Third-Party Audit program and provide a platform to discuss potential solutions.

“FDA’s program involves certification of regulatory compliance, which is an entirely new approach for CB’s currently involved in the GFSI system,” says Wester. “As currently structured, the individual CB’s responsibilities will include activities such as audit checklist development and auditor training requirements that will negatively impact audit consistency and dramatically increase audit costs. Another key concern is maintaining the audit documents, because regulations do not change on a regular cycle like GFSI, further adding costs and variability to the program.”

Supported by AFSAP’s food safety partners, NEHA and ANSI, long-time supporters of AFSAP’s efforts to raise awareness of FSMA’s use of audits, the Food Safety Supply Chain event provided the ideal venue to hold the discussion.

About AFSAP

The Association for Food Safety Auditing Professionals is a member driven association created to advance and support the professional development of food safety auditors globally. As a 501(c)(3) Trade Association, AFSAP provides a universal platform for individual auditors and the auditing community at large to harness their combined experience and knowledge into a powerful tool equal to the significant challenges that lie ahead. Working together, AFSAP members will have an unprecedented opportunity to engage regulatory agencies and external stakeholders with a unified voice, and collaborate on the development of creative solutions to the issues facing the food safety auditing industry.

About Food Safety Tech

Food Safety Tech is an industry-specific eMagazine and Conference series serving the global food industry. Built on the platform of the next generation model for B2B publishing, Food Safety Tech delivers top quality content in a proactive manner through a weekly eNewsletter while maintaining a website, the eMagazine that stores the content providing easy accessibility. This hybrid model provides a two way street of digital communication to the global food industry. Food Safety Tech is published by Innovative Publishing, LLC.

FDA

FDA’s Data Dashboard Helps Companies Meet FSMA Supply Chain Requirements

By Food Safety Tech Staff
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FDA

FDA has launched a new section of its Data Dashboard to help food importers, manufacturers and processors meet supply chain requirements put forth by FSMA (specifically FSVP, and the PC rules). The dashboard provides ease in finding compliance and enforcement information related to companies.

Do you trust your suppliers? What about your supplier’s suppliers? | Food Safety Supply Chain Conference | June 12–13, 2018 | Learn more“The Foreign Supplier Verification Programs rule requires importers to perform risk-based activities to verify that their suppliers are meeting applicable U.S. food safety standards. One such activity is an evaluation of a supplier’s performance and the risk associated with the food, a process that includes evaluating a supplier’s compliance with FDA regulations such as whether the supplier is subject to an FDA warning letter, import alert, or other FDA compliance action related to food safety. The Preventive Controls rules require manufacturers/processors to perform supplier approval if the ingredient supplied contains a hazard requiring a supply-chain applied control. Supplier approval includes consideration of the supplier’s compliance with food safety laws and regulations.” – FDA

The agency also made improvements to its supplier evaluation resources page and added it to the dashboard so that companies can simultaneously search several databases. Users can search for information about warning letters, import refusal and import alerts.

 

Compliance, food safety

Leveraging FSVP Compliance: Do Less, Get More

By Benjamin England, Nicole Trimmer
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Compliance, food safety

With an ever-expanding international food trade and new government demands for food safety and supply chain transparency, the U.S. regulatory landscape is becoming increasingly more complex. FSMA (especially the Foreign Supplier Verification Program) aims to shift responsibilities for imported food safety from FDA to importers in an effort to reduce the regulatory burden on FDA. New regulations bring new burdens to food trade stakeholders, requiring significant investment. However, many of the data obligations of the FSVP rule dovetail with other agencies’ requirements.

Investments in one dataset can be leveraged to improve a company’s overall compliance related to international trade. The key is to integrate FSVP requirements into a strong regulatory compliance program without breaking the bank. This requires identifying data overlap, utilizing compliance integration to work smarter, not harder, leveraging the window of opportunity to collect more (and necessary) data from your foreign suppliers, and calling in the right help when needed.

TRUST…..BUT VERIFY: 2018 FSMA Focuses on Supplier Verification Activities | Learn more at the Food Safety Supply Chain Conference | June 12–13, 2018 | Rockville, MDToday’s International Supply Web

No longer can we reasonably talk about establishing, monitoring and maintaining a supply “chain” when importing anything. International trade in food and its ingredients is rarely bilateral—except for perhaps fresh produce, meat and seafood. Instead, food moves throughout a complex supply web of international transactions. Most processed food now contains ingredients from multiple countries, leading to food safety verification challenges and country of origin questions for finished goods.

The international supply web includes farms (land and aquaculture), agriculture cooperatives, food grade chemicals manufacturers, color and flavoring formulators and manufacturers, raw materials processors and fabricators, finished food processors & packers, warehouses, transportation companies, cooking, canning and irradiating facilities, shippers, exporters, product and commodities brokers, importers, wholesalers, retailers and e-tailers. Any (or all) of these players may be small operations located in different countries or multi-national conglomerates operating on several continents. There is very little food consumed in the United States that is not affected, in some way or another, by international commerce and trade.

Shift to a Preventive System

In 2011, Congress passed FSMA with the goal of moving U.S. food safety from a reactive to a preventive system, and integrating HACCP-like principles into the production of all food. Over the ensuing years, FDA issued seven major regulations that address various facets of food safety.

The Foreign Supplier Verification Program (FSVP) rule was included as a way to ensure that foods imported into the United States are produced in a manner that meets U.S. safety standards. FSVP requires that “importers,” which can be the distributors or retailers of products, verify and document the steps taken to ensure safe production of animal and human food. While the exact FSVP requirements vary depending on the commodity, the FSVP process often includes developing, maintaining and documenting a food safety plan and, as its name suggests, verifying that foreign suppliers are controlling for appropriate hazards. Developing and implementing these plans requires a wide variety of skills, including hazard analysis and risk assessment, establishing preventive controls, developing recall plans, and careful documentation of the process. FSVP also requires that verification activities be carried out by parties who have specific preventive control training, or “PCQIs” (Preventive Control Qualified Individuals).

Most importantly, FSMA and the FSVP rule shift the burden of safety from FDA to the importer. With increased interconnectedness, flaws in food safety documentation can become magnified throughout the system. Note that FSVP covers food safety only—not necessarily food traceability or food security defense—although there are opportunities for crossover ROIs. To achieve FSVP compliance, you need to know who is handling your food before it is imported, what they know about food safety, and how they apply food safety principles.

Cross-agency Data Usage

Approaching FSVP as a stand-alone regulatory compliance initiative is expensive and inefficient. Many activities and data elements that must be kept for other government agencies and their compliance programs should be linked together. The data your foreign suppliers must provide to international carriers for advanced notice to U.S. Customs and Border Protection (“CBP” or “Customs”) by importing carriers (airlines, trucking companies and vessel operators) is relevant to both Customs entry and FDA food safety compliance and documentation. This overlap presents an ideal opportunity to relieve the burden of the new FSVP requirements and kill two birds with one stone. And the overlap and leveraging opportunities are actually quite substantial—if one knows where and how to look for them.

For example, the USDA’s National Organic Program (NOP) regulations specify requirements for the processing, handling and labeling of raw materials and processed goods to meet organic standards. Organic labeling and marketing claims are affirmative assertions that the labeled food has not been exposed to processing steps, processing chemicals or particular substances (e.g., sewage sludge, ionizing radiation) that would cause it to fall out of the regulatory bounds of an organic food product. Where organic processing and handling crosses over to food safety, leveraging organic compliance documentation buttresses the safety of the resulting food—and the importer’s FSVP program.

Additionally, much of the information that the importer must know to properly classify their product under the Harmonized Tariff Schedule (HTS) is the same information that the importer needs for their FSVP plan; the importer must know the products, what they are made from, how they are processed, and how they are intended to be used to both properly classify and verify the safety of their product. Because FDA requires the importer to verify that its foreign supplier has a system that meets the domestic food safety standards, the foreign supplier must also be able to identify its own ingredient and raw material suppliers and their systems for food safety, as applicable. Therefore, the food importer’s FSVP process promotes documentation compliance with CBP’s and other government agencies’ requirements governing the country of origin of materials for applicability of preferential duty rates (e.g., under a free trade agreement) and country of origin labeling.

Another example of data overlap is the FSVP requirement for supplier verification and the responsibility to show correct valuation of your product for Customs. FSVP requires that you verify your suppliers and ensure your product is genuine, and Customs requires that you declare an appropriate valuation and identity for your shipment. If Customs investigates your shipment and determines your valuation is incorrect, it may trigger the Department of Commerce to investigate whether there are anti-dumping and countervailing issues going on with the product.

Issues with anti-dumping and countervailing duties are extremely time-consuming and expensive. In both 2008 and 2016, federal authorities investigated rumors of companies circumventing anti-dumping duties by transshipping food products through third countries (to conceal actual origin of the material). When Customs investigated a honey processing plant, they found evidence that the purported processor of Vietnamese honey was receiving finished product from China and relabeling it as originating from Vietnam. When importers declared imported Vietnamese honey, Customs determined from trace mineral testing that the honey was, as they suspected, Chinese. Customs seized the product. The lesson to learn from this is to know your suppliers and the actual supply web. In the case of country of origin violations, not verifying the country of origin can be costly. Where CBP finds negligence is involved, the agency can look back five years to recoup lost duty plus interest, and can even reopen old liquidated entries and assess monetary penalties. In completing your FSVP plan, requesting documentation demonstrating origin is a small additional step that furthers the strength of CBP-required documentation to support the origin declaration at entry. That’s leveraging.

Document, Document, Document

Under the Customs Modernization Act of 1993, the compliance watch-words for all importers (and customshouse brokers) are “record keeping,” “shared responsibility,” “reporting,” and “due diligence.” Anything that is required for a proper importation is subject to CBP review and audit—whether the requirement arises as supply chain and source data under the Seafood Import Monitoring Program (SIMP) under the National Marine Fisheries Service (NMFS), or organic labeling and compliance under USDA’s NOP regulations, or speciation documentation under the Lacey Act enforced by U.S. Fish and Wildlife (USFW), or FSVP implemented by FDA. Therefore, the engagement between food importer and foreign food supplier forced by FSVP opens the opportunity for the importer to clarify and shore up its documentation obligations for many other coexisting regulatory regimes.

A clear demonstration of this fact is borne out by the regular process that ensues when CBP issues to an importer of record a Customs Form 28 (or “CF28”). The CF28 is a CBP request for additional information relating to an imported shipment. The importer is usually required to respond within 30 days of its issuance. But ordinarily the CF28 is issued months (and sometimes years) after the importation occurred. Therefore, the CF28 process represents a significant challenge to the importer’s record keeping and compliance documentation systems, and legal liability to the importer’s bottom line.
Documents needed to respond adequately to a CF28 include contracts, purchase orders, packing lists, shipping documents, declarations to government authorities throughout the import process, powers of attorney, country of origin certifications, emails and other communications discussing any of these documents. CBP requests these documents to confirm the proper electronic data was submitted with the importation. And, of course, CBP is checking to see if the importer is attempting to circumvent U.S. import or export laws that may deprive the government of revenue.

The identity and location of an importer’s trading partners (including the foreign supplier and its suppliers), contracts between and among them (e.g., related to description, processing methods, equipment used, quality and condition of goods), origin documentation, proofs of packing and shipping, etc., are all subject to production via the CF28 process. Penalties for errors in the documentation that result in a regulatory or administrative action are imposed upon the importer (for failing to document or exercise due diligence in performing its function as an importer under U.S. law).

The FSVP regulation presents an ideal opportunity for the importer to establish and populate a compliance program that integrates its FDA import regulatory obligations with those of CBP and other regulatory agencies, as applicable. Failing to take this rare opportunity—at a time when foreign suppliers are expecting probing questions from their U.S. trading partners—is a mistake.

Because the government is more connected, it is essential to change how you prepare for and respond to issues that arise. Just as the FDA’s FSVP rule aims to move food safety from a reactionary to preventive system, coordinated proactive compliance with all government agency requirements will be necessary for the future. Further, with new regulations, your customs broker may not be equipped to deal with certain areas or when administrative matters escalate. But how do you prepare for any eventuality when the enforcement possibilities seem endless?

When preparing your FSVP plans, reviewing your Customs documentation, and reviewing other government agency requirements, it is critical that you think through all the potential issues that may arise with your product or its supply chain, and address them proactively in your documentation. What might an inspector or compliance officer think about the information provided? Is it thorough, clear, and logical? Does it tell a consistent narrative? What if another agency sees this information? Will they have further questions? The ultimate goal is accurate and thorough data for submissions to FDA, Customs and any other partner government agencies.

Key Steps to Prepare for the Worst-case Scenario

Lastly, let’s not forget that part of being prepared is preparing for the worst-case scenario. What happens when you are confronted by an issue? We recommend taking four key steps. First, marshal your resources (documents, documents). Second, ask, “Who are the key players in the story (e.g., which agencies are involved or could possibly be involved, and what are they requesting)?” The third question, a bit less straightforward, is, “How must I respond? (e.g., is the agency within its regulatory authority and required time constraints; are there conflicts of interest; what is the potential legal exposure to risk for different actions)?” Finally, do a gut check: Are the examinations subjective in nature or qualitative (rather than quantitative)? Is any required testing appropriate for the product? If you feel you cannot confidently answer these questions using current staff, we recommend you prepare for import issues by selecting professionals who have experience with integrated agency regulations and legal compliance requirements. The keys to expediting the process when working with multiple government regulatory agencies are integrating your compliance to ensure you have a true green-means-go light before you ship and being able to present a clear and consistent regulatory narrative to all agencies. This requires a clear understanding of how the government regulatory requirements actually intersect.