On Tuesday Secretary of Agriculture Sonny Perdue announced the posting of technical documents pertaining to the shipments of U.S. beef to China. Last month the United States and China reached a trade agreement that allowed the export of American beef to China, where the meat has been banned since 2003.
The USDA Agricultural Marketing Service posted the requirements for the Export Verification program for U.S. companies shipping to China. The program will allow packers to apply for approval to export to China. In addition, FSIS updated its online Export Library with China’s requirements for certifying U.S. beef.
According to the USDA, China’s beef imports have increased from $275 million in 2012 to $2.5 billion in 2016. As the world’s largest beef producer, the United States generated more than $5.4 billion in global sales last year.
Last week a panel of industry authorities gathered to share their perspectives on the importance of transparency in the supply chain and the challenges that food companies experience in managing different aspects, from their suppliers to once product reaches retailers.
“Understand that food safety today has changed significantly and will continue to change. It’s a dynamic field and regulations have only accelerated,” said Jorge Hernandez, chief food safety officer at The Wholesome Company. “You need to be more proactive internally and externally.”
Moderated by John Wadie, U.S. marketing operations manager for 3M Food Safety, the other panelists were Melanie Neumann, president of Neuman Risk Services, LLC and Terry Levee, Senior Director, Giant Eagle.
The supply chain of a single product often involves multiple levels. For a company to adequately evaluate its risk and vulnerability, it must have a grasp on the full extent of its supply chain, according to Amy Kircher, Dr. PH, director, Food Protection and Defense Institute. “When we think about the supply chain there are two points to consider: One is just being aware of the depth and breadth of a supply chain to create a food product. It’s much larger than who you buy from and who you sell to,” says Kircher. “Second is moving from a reactive mentality to a proactive mentality. How do we get ahead and close vulnerabilities before they are exposed or monitor threats to the food system such that we can put mitigations in place.” During a discussion with Food Safety Tech, Kircher shares her perspective on how companies can understand and protect their supply chain.
Amy Kircher, Dr. PH, director, Food Protection and Defense Institute
Food Safety Tech: What are the biggest supply chain threats facing food companies?
Amy Kircher: I think one of the biggest challenges is just understanding the entire food supply chain and all the buying, selling and manufacturing that happens along that line. When food comes from a point of origin—whether it’s a farm or a manufactured nutrient—what are all the steps and movements of that product that then results in the final product that the end consumer buys? Typically companies know at least one [step] back and one [step] forward, but they don’t always know the entire breadth of the particular ingredient that they’re buying. Or, if they’re in the middle of the supply chain, [they may not know] where all of their products may be going if it’s sold multiple times (i.e., a spice as an ingredient). There are exceptions—some companies are vertically integrated and know their entire supply chain. But on average, that is a real challenge: Understanding the complexity of the supply chain, where are you in that process, whom you are buying from, and where the food is going afterwards.
FST: How can companies gain a better understanding of their supply chain?
Kircher: Ask questions of whom you’re buying product from—from where are they sourcing the ingredient or commodity? For example, if you’re making a five-component food product, ask your supplier, where does it get its stock from? From where are you sourcing? Have an open dialogue with your vendors and make sure you have the process in place so if you had to quickly identify where an [ingredient] was from, you could.
Secondly, understand the ingredients that you need to procure and be able to monitor where there might be threats for that particular product or commodity. If you need to buy peppers as an ingredient for a spice blend or a can of soup, [you should] be able to monitor what’s happening in that particular commodity: Has there been an intentional adulteration recently? Any recalls? Have there been weather issues in the part of the world where your particular pepper is sourced? If we know there is a natural disaster in a region, how quickly are you notified? Do you have alternate sources as a backup?
A great example is the Ebola [outbreak]: When Ebola happened, there were changes that were happening with cocoa almost daily, because most of the cocoa is sourced out of West Africa, exactly where Ebola was happening. There were price shifts and some transfer concerns where cargo ships weren’t coming into port in some of those countries. It’s important to have an understanding of the ingredients or commodities that you source and be well aware of what’s happening in that landscape.
FST: What steps should companies take to protect their supply chain?
Kircher: You should be doing vulnerability and risk assessments of your supply chain. Know where there are risks of that particular supply: Those risks could be a multitude of things, be it a natural risk or something related to a change in trade policy. Know where you have vulnerabilities within your system: Where could a particular product be exposed to a vulnerability, either natural or intentional? [From there], start assessing what can be done about it. If there’s a specific ingredient that you need to have to make a particular product, where does it come from and do you have alternative sources? What kind of testing mechanisms do you have in place? Some vendors only have one manufacturing site or one receiving site for a product they’re manufacturing. How secure is that processing plant? Is it in a hurricane zone? Have you had criminal activity there? Understanding where there are vulnerabilities in your supply chain allows you to prioritize which ones you should spend money on mitigating.
FST: What technologies do you find to be the most effective in assessing risks and providing visibility throughout the supply chain?
Kircher: I think there are several products that will help. At the Food Defense and Protection Institute, we have a couple. The first is a supply chain documentation and analysis tool (CRISTAL) that allows you to document your supply chain throughout the whole system. Then it applies weights and algorithms to allow you to see what is most critical in your supply chain, and from there you can look at risks from hazards. For a lot of companies, the first step is to map the entire supply chain. Having technology that allows them to do that efficiently versus drawing or creating an Excel spreadsheet allows them to visualize where they might have gaps/challenges, followed by risk and vulnerability assessment.
Second is horizon scanning, or looking at early indications of warnings of events. Our tool is called FIDES (Focused Integration of Date for Early Signals). It looks at predicative analytics—are there conditions or drivers that are occurring that might result in an emerging event or event that might create a problem? We can always scan and monitor where we might have challenges.
We want to move people from a reactive food protection and defense to a preventive posture where you are starting to be ahead of it [threats] and understand where you might have a risk or vulnerability that gets exposed such that you can mitigate it prior to a consumer purchasing [the product].
Food importers have clear objectives: To successfully bring safe food into the country by clearing U.S. Customs and Border Protection, to avoid FDA detention and to conduct business competitively in the United States. Under the FSMA final rule on Foreign Supplier Verification Programs (FSVP), importers must ensure their food is as safe as if it were produced in the United States and that it is not adulterated or misbranded.
Compliance, of course, is of utmost importance when it comes to avoiding issues with the FDA. However, in a more realistic sense, the best way to stay out of trouble with FDA is to avoid two circumstances, advised Russell Statman, executive director at Registrar Corp. (the firm is a U.S. agent for about 15,000 foreign facilities)—being dishonest and not taking the requirements seriously.
“Once you fall into one of those boxes, you’ll never get out,” Statman said. “It’s important when dealing with FDA to remember that. It’s not a building; it’s people. They don’t want to stop your shipments; they want to facilitate trade.” If your company is honestly working toward and making an effort to follow the rules, “FDA will keep working with you until the cows come home,” he said.
Statman discussed practical information surrounding FSVP that importers should consider during the Food Safety Supply Chain Conference earlier this week. Although there is flexibility built into the FSVP rule (as there is with all seven FSMA rules), importers must follow the law. To start, every importer must have DUNS number (provided by Dun & Bradstreet), which is free of charge. However, this can be a challenge for foreign companies, particularly those in China, according to Statman, who also said there may be instances in which Dun & Bradstreet tries to charge a fee. “It’s supposed to be free and quick. If you have problems with Dun & Bradstreet, you want to let FDA know.” He offered key pieces of advice for the FSVP requirements:
Hazard analysis. “You can’t rely on other people. If you’re producing food, do your own hazard analysis. Create a pamphlet that you can give to your customers. Then you don’t have to deal with all these requests—keep updating [the pamphlet], so it’s a living document. If you’re a foreign supplier and have a booklet, you’re steps ahead of your competition.”
Approval and compliance status review of suppliers: Check their record with FDA to find out whether they have any warning letters or on import alert. “That doesn’t mean you can’t buy from them, it just means you have to investigate what the problem is,” said Statman, but added that a lot of U.S. companies will not buy from importers that are flagged with an alert. And in many cases, companies do not know that they’re on import alert, so visit FDA’s website frequently to make sure you’re not on the list. “FDA doesn’t tell you when you’re on import alert. You want to check [because] asking them might not be good enough.”
Supplier verification activities: Verify that importers follow the entire rule.
Corrective actions
Periodic reassessment of FSVP
Importer identification at entry (DUNS number)
Recordkeeping: “In a very real, practical sense, your record stays with you,” said Statman. “If you’re an importer, you don’t want your shipment detained by FDA.” FDA uses a computer system called PREDICT that determines which entries they stop. The system comes up with a score for shipments that are at the highest risk. “Your PREDICT score if very important—some of these factors are secret, [and] some are public. The most important are in your control—your record and the importers record,” he added. “Before you send your first shipment for a new product, make sure everything is correct (i.e., registration, labeling). It’s worth the time.”
Need more help with setting strategic goals and tactics for success in supply chain quality assurance management? This month an upcoming webinar will help attendees do just that, along with delve into the perspectives of two project managers of Fortune 500 companies and how they used a supplier quality management software platform to manage quality assurance.
The complimentary webinar “Achieving Significant Goals in Supply Chain QA Management” (Register) will be held June 22, 2017 at 11 am ET. Speakers include Sandy DeGroot, formerly of Campbell’s Soup organic division, John McGlinn, vice president of sales at EMNS, Inc., and Justin Ramos, partner at Brand Solutions Group.
Food Safety Tech recently spoke with Katy Jones, chief marketing officer at FoodLogiQ about consumer preferences and their expectations during a product recall, along with how food companies can manage better visibility further in their supply chain.
The complimentary webinar, Top Tips to Mitigate Food Fraud, takes place on June 22 at 1 pm ET. Register now.Recently, the topic of food fraud has been discussed with increasing urgency. From understanding the basics of what is food fraud to navigating the regulatory requirements, quality assurance, compliance and procurement professionals must have a general understanding of the components.
An upcoming free webinar will review the hazard analysis requirements surrounding the FSMA Preventive Control for Human Food, GFSI requirements for raw materials and risk assessments and food fraud mitigation plans. Attendees will also learn about food fraud mitigation implementation strategies. The speakers participating in this webinar are Jeff Chilton, vice president of professional services at Alchemy Systems and Peter Claise, marketing director for foods programs at USP.
Accurate labeling of gluten-free products is a big deal for consumers who have celiac disease, as they can suffer potentially serious health issues when they eat gluten. FDA set standards for the labeling of gluten-free products in August 2013 (with a compliance date of August 5, 2014) and recently announced results of a sampling assignment that was conducted to assess compliance with the final rule.
Of the 702 samples taken from 250 products labeled as “gluten-free”, FDA found that more than 99.5% of the samples to be in compliance with the agency’s requirement.
“Of the total number tested, five samples from one product source contained gluten in excess of the regulatory limit of 20 parts per million (ppm), for a product-based rate of compliance with that requirement greater than 99.5 percent. A voluntary recall was conducted to address concerns related to the violative samples. In addition to carrying out the recall, the manufacturer conducted an extensive root cause analysis and immediately implemented additional corrective actions to prevent recurrence.” – FDA
Over the past few days, there have been two more large meat recalls. In both cases, there have been no confirmed reports of adverse reactions due to product consumption.
Golden Gourmet Recall
Golden Gourmet has recalled more than 5,000 pounds of frozen waffle and turkey sausage products over concerns of contamination with Listeria monocytogenes. The issue was uncovered when the company received a letter of notification from US Foods, its supplier, that products had been recalled. The Class I recall involves products that were produced and packaged on December 21, 28, 29 and 30, 2016 and shipped to locations in Georgia, Iowa, Illinois, Ohio, South Carolina and Tennessee.
Armour Eckrich Meats Recall
FSIS also announced a Class II recall initiated by Armour Eckrich Meats, LLC over concerns of metal contamination. The company recalled nearly 91,000 pounds of ready-to-eat fully cooked pork, turkey and beef breakfast sausage products that were produced and packaged from April 26 through April 28, 2017 and shipped to distribution centers in Arkansas, Indiana, Kansas, Louisiana, Oklahoma and Texas. Armour Eckrich Meats discovered the problem when it was notified by an FSIS-regulated establishment that pieces of metal were embedded in the sausage product produced by Armour Eckrich.
With several FSMA compliance dates now in effect, much of the focus is on where companies need help. According to Kathy Gombas, former deputy director at CFSAN, the industry is struggling with FSMA training. Many companies don’t understand the FSMA rule exemptions and supply chain requirements, and they just don’t know where to start. “Industry needs affordable and timely resources,” said Gombas during a panel discussion at the Food Safety Summit earlier this month. “There are a lot of tools out there, but they’re costly.”
Efforts are underway to address these challenges. FDA has issued more than a dozen guidance documents pertaining to the rule. In addition, tools such as model plans and templates can help companies with their food safety plans, and the agency is almost ready to publish a web-based food safety plan builder that will be freely accessible on FDA’s website, according to Gombas. Several sources of technical assistance are available, including state and trade associations, academia, and the technical assistance network (TAN). However, when companies have inquiries, the key is to provide them with a response in a timely manner, said Gombas.
The Produce Safety rule is another hot spot for hurdles. Although 90% of it aligns with Good Agricultural Practices that have been in place for more than a decade, industry’s response to the rule remains one of fear and confusion, said David Gombas, former vice president of technical services for the United Fresh Produce Association. “Water testing is probably the most complicated aspect of the regulation,” he said. The rule calls for testing procedures that many produce companies never had to conduct before. Some testing must be done within a certain period of time, and the lower number of testing labs in rural areas of the United States will pose a problem for some producers, warned David Gombas.
There is also confusion among producers regarding whether they should follow the Produce Safety Rule or the Preventive Controls rule, which could significantly impact the steps they must take to be in compliance of either rule. To further complicate matters, Gombas pointed out that many foreign suppliers aren’t even aware that they have to be in compliance with the rule. Finally, the Produce Rule does provide a lot of room for flexibility, so Gombas predicts much of the responsibility will fall on the agency inspectors and how they expect rule to be met.
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