King Arthur Flour is voluntarily recalling 14,218 cases of product.
Another customer of ADM Milling Co., King Arthur Flour, Inc., is voluntarily recalling its five-pound bags of unbleached all-purpose flour due to potential contamination with E. coli O26. The recall affects 14,218 cases of product with six specific lot codes and “best used by” dates of 12/07/19, 12/08/19 and 12/14/19. According to a King Arthur Flour company announcement, ADM Milling notified them that certain wheat used to make the above-mentioned product lots has been linked to an ongoing E.coli outbreak. King Arthur Flour states that this recall does not affect its products sold through the company’s website, Baker’s Catalogue or its Baker’s Store in Norwich, VT.
Just a couple of weeks ago, ADM Milling expanded its flour recall to include all five-pound bags of Bakers Corner All Purpose Flour, which is packaged by ALDI.
Consumers are advised to discard the product or return them to the place of purchase for a credit or refund.
There are two key points that Kevin Otto of GS1 wants people to understand about blockchain: It is not a traceability solution in itself, and data standards are critical. Otto is the lead for the GS1 US Cross-Industry Blockchain Discussion Group (launched in November 2018) and the Foodservice GS1 US Standards Initiative at GS1 US. Recently the blockchain buzz has been transforming into a more realistic conversation about the future role of the technology in supply chain visibility and the necessary steps to achieve interoperability. In a Q&A with Food Safety Tech, Otto shares what GS1 is trying to accomplish with its relatively new blockchain discussion group, the important role of data standards, and supply chain traceability.
Food Safety Tech: Can you explain the role and goals of GS1’s blockchain discussion group?
Kevin Otto, lead for the GS1 US Cross-Industry Blockchain Discussion Group and the Foodservice GS1 US Standards Initiative at GS1 US.
Kevin Otto: It’s a cross industry discussion group, so it’s a bit of departure from how we typically approach industry with verticals such as foodservice or retail/grocery. For the blockchain discussion group, we decided to bring different industries together under one umbrella—leading companies within foodservice, retail/grocery, healthcare, and apparel/merchandise—to discuss the use cases and implementations for blockchain. The common thread among so many industries was a focus on improving supply chain visibility. We thought it was a good opportunity to see where we could get alignment and be industry agnostic around how blockchain can be leveraged.
There were a few overarching goals that we were trying to accomplish with the group: The first thing we heard from industry is they’d really like some education without the hype. There seemed to be some confusion with some industry partners that blockchain itself is a traceability solution, which it isn’t. We know that a blockchain implementation is only as good as the data that is feeding it. We want to help various players in these industries clear up confusion, [and understand] that there’s still a need for data standards in order for blockchain to produce meaningful results. As a neutral not-for-profit organization, we thought we’d be a good place to provide education and industry insight.
In terms of other things that this group is trying to do: One thing that we thought was abundantly clear was the need to identify and align on the necessary core standards and master data elements to even approach a trading partner with a supply chain visibility proof of concept leveraging blockchain. If you want to talk about supply chain visibility with your trading partners and you’re not capturing and sharing any standardized data about how product moves through your supply chains today, there’s really no way you can even begin to discuss blockchain with them.
This goes back to the confusion in the industry where people think they can adopt “blockchain” and therefore have traceability. Supply chain visibility is a priority across all of these industries. Now is the time for them to decide what separate pieces of traceability data and master data are needed in order to have these discussions with trading partners. The discussion group will be putting out guidance on what is specifically needed for a blockchain traceability proof of concept.
Another major thing industry had asked from us: A knowledge management center, which is an interactive space where participants in the industry discussion group can post articles, ask probing questions, and interact with people outside of their four walls, and discuss progress of their own proofs of concept. We have been developing this tool over the last couple of months and will launch this summer.
FST: Are there additional the concerns about the use and implementation of blockchain technology?
Otto: There’s a lot of investment that goes into blockchain technology, and we saw a lot of people jumping in with both feet before understanding what the benefit really was to their organization. It’s almost as though blockchain was being positioned as a solution for all supply chain problems. We thought that being able to provide some of this education and insight from industry would help to elevate some of those issues.
I think one of the other concerns that plays a role is interoperability. When you talk about the ability for these different blockchain ecosystems to effectively speak to one another, there’s certainly a need for data standards in that space. There isn’t going to be just one blockchain solution; there are going to be several different players out there and they will need to leverage standards as one step toward interoperability. Our perspective is that we have companies that are already leveraging GS1 standards today through other data sharing mechanisms, and there’s no need to reinvent the wheel. These standards already exist; let’s make sure we’re using what’s been tested over time, which is a key step in helping ecosystems speak to one another.
FST: How is the use of digitized data provoking a shift in supply chain processes?
Otto: There are still smaller players within the food space who are leveraging paper-based data exchange with their trading partners. As the supply chain grows increasingly more global, the idea that you can have effective track and trace, for example, when the only thing you know is where a product was immediately before it came to you and immediately where it went after it left just doesn’t work anymore. It’s too slow and, quick frankly, dangerous if you have that much manual interaction and that much reliance on paper-based processes in a global supply chain. Certainly we’re seeing more trading partners make digital data exchange one of the prerequisites of their sourcing. The supply chain has gotten so complex that it just isn’t realistic to expect people to play “whisper down the lane” in figuring out where their product went in the event of a recall.
And when you think about the impact of social media and how quickly a recall can become much bigger, it’s imperative that some of these companies within the food and retail industries make sure their processes are buttoned up and that they can communicate with their trading partners quickly, and pull that product out of the supply chain. I think we’re seeing companies saying, if you don’t have a mechanism to electronically exchange data, then we may have to take our business elsewhere.
FST: Talk about your thoughts related to traceability and the need for companies to “speak the same language”. Where are companies in this journey, and where do they need assistance?
Otto: Speaking the same language is imperative. The most sophisticated data sharing methods in the world are of very little use if I don’t understand the data being sent to me. There aren’t any manufacturers, retailers, operators, etc. in the food supply chain whose stated core competency is translating data from their trading partners. That’s why so many of these different companies are relying on GS1 standards—the global language of business—so they can focus on what they do best—providing high quality, safe products to their consumers
In terms of where companies are on this journey: It varies. There are companies that have been adopting standards for traceability for years, and there are always other companies being on-boarded. This is a marathon, not a sprint. The important thing to realize is that this is a business process, not a project. Food traceability is something we need to work at everyday. As we work with all these different companies, they’re increasingly saying that food safety isn’t a competitive advantage—it’s something we all need to do and we all benefit from.
Where assistance might be needed: The food service supply chain is large and complex. When looking at the tens of thousands of independent growers as you get further upstream in the supply chain, we work with other industry associations to make sure they understand our messaging and how GS1 standards can provide value for their business. The challenge is always going to be that if we want to get to farm-to-fork traceability, we have to make sure we are talking to all the independent farmers and growers that you just can’t simply call or talk to on a daily basis. We leverage partnerships to be our voice in those discussions so we can truly connect with the entire food supply chain. That will be a continuous ongoing effort.
Food accounts for one-third of the 42 million products imported into the United States each year, according to Andrew J. Seaborn, supervisory consumer safety officer, division of import operations, ORA, FDA. FSMA’s risk-based FSVP rule places responsibility on importers to ensure their food is safe, yet since the rule was implemented, the most common Form 483a observation has been a failure to develop an FSVP. In fact, from FY 2017 to present, the observation was cited 552 times, outweighing any other observation, said Seaborn at the recent Food Safety Supply Chain Conference, as he shared some of the latest trends in compliance and enforcement related to FSVP.
Thus far, common citations include:
No written hazard analysis to identify and evaluate known or reasonable foreseeable hazards
No written procedures that ensure appropriate foreign supplier verification activities are occurring related to imported food
Seaborn noted several additional “significant observations” related to FSVP inspections, including incorrect entry data, and the absence of documentation in the following areas:
Approval of a foreign supplier
Evaluating foreign supplier performance, along with related risks
Establishing written procedures to ensure foreign supplier verification activities are performed
Review and assessment of another party’s evaluation of foreign supplier performance
Ensuring food was produced in compliance with low acid canned foods regulations
Related to meeting the definition of a very small importer, when applicable
Main Points of FSVP
FSVP Inspections (Completed)
U.S.-based importers responsible to ensure safety of imported food
Last week USDA announced two Class I recalls involving possible foreign matter contamination. Perdue Foods, LLC has recalled about 31,703 pounds of certain ready-to-eat chicken products that may be contaminated with bone material. The products, which were shipped nationwide and include plastic trays of Simply Smart Organics Breaded Chicken Breast Tenders (gluten free and whole grain), and Chef Quik Breaded Chicken Tenders Boneless Tender Shaped Chicken Breast Patties with Rib Meat were produced on March 21. The full list of products is on the FSIS website and have the establishment number “EST. P-369” inside the USDA mark of inspection. Thus far there have been no confirmed reports of adverse reactions following consumption of these products.
Johnsville, LLC has recalled nearly 95,400 pounds of its ready-to-eat jalapeno cheddar smoked sausage products after a consumer complaint involving green hard plastic in the product. The 14-oz packages of the product were shipped both nationwide and internationally, were produced on March 12 and 13, and have the establishment number “EST. 34224” inside the USDA mark of inspection. Thus far there have been no confirmed reports of adverse reactions following consumption of these products.
Last week industry gathered for the Food Safety Supply Chain conference at USP in Rockville, MD. The following are some quick highlights of insights they shared.
Most Common Form 483 Observations
Following FSVP inspections, the most common Form 483 observation was a company’s failure to develop an FSVP. From FY 2017 to present, the observation was cited 552 times, outweighing any other observation and underscoring the need for an educational component. – AJ Seaborn, supervisory consumer safety officer, division of import operations, ORA, FDA
(left to right) AJ Seaborn, Lisa Ross and Priya Rathnam of FDA share an update on FSMA implementation at the 2019 Food Safety Supply Chain Conference
Top Citations for FY 2018
Hazard analysis (when a facility is not identifying a hazard that requires a preventive control)
Lack of a food safety plan. “There’s still work to be done on the education and outreach on this one.”
Equipment and utensils (GMP deficiency)
Allergen controls monitoring
Sanitation control verification procedures
Personnel (usually, this is related to a repeated issue)
– Priya Rathnam, supervisory consumer safety officer, CFSAN, FDA
Critical Supplier Questions Must Be Asked
How do you choose and approve your suppliers?
What must be done to ensure that we aren’t receiving hazards from suppliers?
What requirements must be defined?
Does every supplier need to be audited?
Should we treat all suppliers equally? (No, it depends on their risk profile)
How do we ensure that our program is effective?
When working with suppliers, it’s important that your decisions are reproducible and that you apply the same risk methodology across the board. – Erika Miller, food safety specialist, D.L. Newslow & Associates, Inc.
“Before you can do anything to transform your business, you have to have visibility in your supply chain.” – George Dyche, senior director, innovations & solutions, Avery Dennison
“’Compliance’ should be replaced in industry with ‘commitment’…when you’re committed, compliance will follow.” – Felix Amiri, food sector chair, Global Coalition for Sustained Excellence in Food & Health Protection (GCSE-FHP)
Putting the “P” in CAPA = Getting out in front of issues before they happen. “Don’t wait for the consumer to get sick… if you have a recall, it means you haven’t done your work on the CAPA side.” – Andrew Kennedy, director, Global Traceability Center, IFT
(left to right) Felix Amiri, Lucy Angarita and Andy Kennedy discusss supply chain vulnerabilities and solutions.
On critical success factors to establish a traceability program: Technology will never fix a company’s data quality or process issues. If you don’t already have it defined, you won’t get there. And after you understand the KPIs and goals, don’t give up. This doesn’t happen overnight. Engage your leadership, because the vision has to be from the top for others to also allocate the time and effort. “It’s a journey, not a destination. If you take your eyes off data quality, data quality goes down.” – Lucy Angarita, director, supply chain traceability, IPC/Subway
In 2018, 47% of recalls were allergen related, and this rate has increased. “People still don’t get [allergen labeling]”. – Barry Parsons, senior consultant, PTI Consulting Group (Division of Paster Training)
On the significance of teaching truck drivers the importance of food safety risks: “They are part of our supply chain, and we need to incorporate them. It shouldn’t be out of sight, out of mind.” – Holly Mockus, senior industry analyst, Alchemy
Trish Wester, chair of The Association of Food Safety Auditing Professionals, leads an FDA panel discussion about the Third-Party Certification Program. (left to right) Doriliz De Leon, program coordinator, accredited third-party certification program, FDA; Marla Keller, biologist, FDA; Marianne Fatica, policy analyst, Office of Compliance, FDA; Clinton Priestley, consumer safety officer, audit staff, human and animal food operations, ORA, FDA
ADM Milling Co. announced that it is expanding a current recall to include all five-pound bags of Baker’s Corner All Purpose Flour that is packaged for ALDI due to possible presence of E. coli. The issue was uncovered when the Rhode Island Department of Health conducted testing of the product.
The particular strain of E. coli has been connected to 17 illnesses in eight states, but the recall affects flour that was distributed in ALDI stores in 11 states (Connecticut, Delaware, Massachusetts, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Vermont and West Virginia.
The previous recall only affected two lots of the five-pound bags of flour. ADM Milling is advising consumers against consuming flour that has not been thoroughly cooked.
As the use of technology in manufacturing and quality continues to expand, there are many opportunities to help food companies streamline operations and enhance efficiencies. During a brief chat with Food Safety Tech, Melody Ge, head of compliance at Corvium, Inc. talks about the benefits of using technology in manufacturing and why some companies may be hesitant to take the leap.
Food Safety Tech:Your recent Food Safety Tech article, “Changes in the Food Safety Industry: Face Them or Ignore Them”, highlighted the role of technology in improving efficiency. What are the top areas in which companies are challenged to streamline processes?
Melody Ge, head of compliance at Corvium, Inc.
Melody Ge: When talking about a company’s production process, the challenge usually comes from where to start. A company may have difficulty figuring out which areas in the processing line can either be automated or how they can use technology as an advantage.
The challenge could also come from the fact that only parts of the process can be automated with the current technology. For example, with hazard analysis or risk assessment—those processes still need the human brain. So within a process, part of it can be automated, and part of it can’t—that could be another challenge.
FST: What technologies can food companies use to better help them manage risk in manufacturing?
Ge: It depends on what’s out there and what products a company is producing. From a manufacturing perspective, they can use supply chain management software or document management software to help them manage their approved supplier program. Using technology can make it easier and more efficient for companies to manage the risks from incoming goods and suppliers as it centralizes their documentation to make it easy to access.
Technology also helps companies use online software to centralize training documents on one corporate site and deploy it to all employees at different levels.
And from a HACCP and Preventive Controls perspective, companies can use digital technology to document temperature, pH Value, humidity, pathogen testing results, etc.—all the types of data that help execute a HACCP plan can be automated and help manage risk. After all the information is centralized and digitalized, you can see the data and easily translate that to help manage risk.
FST: What are the current technology adoption hurdles, and how are you helping companies understand the value of technology versus a paper-based system?
Ge: I think some hurdles come from fear: What’s going to happen as a result of technology is unknown, and especially at this stage, how FDA will respond is unknown. FDA already announced that this smarter food safety era is coming, but no one knows whether there will be new requirements as a result. Will requirements change because manufacturers are using new technology? Those unknowns make manufacturers fearful about what’s going to happen.
Another fear factor is job loss. For example, if processes are automated, or AI is used to capture data, or record keeping is automated, then what am I going to do? Does the company still need me as a QA professional or supervisor? I think those can stand in the way of making changes. However, [companies or employees] shouldn’t think that way. Technology is not replacing QA professionals, but [rather it] helps them do higher-level jobs. For example, in the time saved by technology, QA professionals can read and digest the data results, and study the trends and recommend best practices to continuously improve their food safety management system. It makes their time more valuable to the company.
Another hurdle is understanding which steps in processes can be automated. There are so many technologies out there that have pros and cons, and whether it will fit with the manufacturer or the facility—there’s an overwhelming amount of information, and the QA technician needs time to digest and understand the process at the facility as well as the technology out there to then select the most suitable technology for a process.
As far as helping companies understand the ROI of technology, there are four areas where I think technology can add value:
It provides increased efficiencies and accuracy of daily operations and data collection. It reduces human error. Let the technology help the food safety professionals document daily operational data.
It streamlines the food safety management system for continuous improvement. Because technology helps the food safety professional do the job of daily data collection, the time saved can be used wisely to study the data and outcomes, and truly understand how they can bring their food safety management system to another level.
It centralizes all the documents and records for management. Using technology, the food safety professional can see their SOPs, records and any related documents in one place. They don’t have to physically go to several places to see what’s happening operationally. This can also help increase efficiency during the audit process.
Centralized data helps the food safety professional more easily see where the deficiencies are located.
Ultimately, the ROI is that advanced technology can help the food safety professional increase operational efficiency, reduce product waste and production downtime.
FST: Any additional comments about the role of technology in food manufacturing?
Ge: In echoing on FDA’s announcement, although the smarter food safety era comes with using advanced technology, the mentality has not changed as all—it’s always FSMA based and people led. We need people to use the technology, and that foundation isn’t changing. We are protecting our consumers from any potential food safety risk. We’re just using a more efficient way to help all of us achieve this goal. I believe in the future, all food facilities will use at least one technology out there to help them automate one or more processing steps. And if you start with one step at a time, it will generally take over the entire production process.
A recall or outbreak occurs. Consumers stop buying the food. Industry responds with product innovation. Government enters the picture by establishing standards, initiatives, etc. “That’s my thesis about how changes happen,” said Michael Taylor, board co-chair of Stop Foodborne Illness during a keynote presentation at last week’s Food Safety Summit. Industry has seen a positive evolution over the past 25-plus years, but in order to continue to move forward in a productive direction of prevention, progress must be made without waiting for the next crisis, urged the former FDA commissioner for foods and veterinary medicine.
The strong foundation is there, Taylor added, but challenges persist, including:
FSMA. There’s still much work to be done in establishing accountability across the board, including throughout supplier networks.
Lack of technology adoption. The failure to use already available tools that can help achieve real-time traceability.
Geographic hazards. This is a reference to the contamination that occurred in the cattle feedlot associated with the romaine lettuce outbreak in Yuma, Arizona. “We’re dealing with a massive hazard…and trying to manage the scientific ignorance about the risk that exists,” said Taylor. In addition, in February FDA released its report on the November 2018 E.coli O157:H7 outbreak originating from the Central Coast growing region in California, also implicating contaminated water as a potential source. “There are still unresolved issues around leafy greens,” Taylor said. “What are we going to learn from this outbreak?”
Taylor went on to emphasize the main drivers of industry progress: Consumers and the government. Consumer expectations for transparency is rising, as is the level of awareness related to supply chain issues. Social media also plays a large role in bringing consumers closer to the food supply. And the government is finding more outbreaks then ever, thanks to tools such as whole genome sequencing. So how can food companies and their suppliers keep up with the pace? A focus on building a strong food safety culture remains a core foundation, as does technological innovation—especially in the area of software. Taylor believes one of the keys to staying ahead of the curve is aggregating analytics and successfully turning them into actionable insights.
Frank Yiannas is the keynote speaker at the 2019 Food Safety Consortium | October 1, 2019 | Schaumburg, IL | He is pictured here during at town hall with Steven Mandernach (AFDO), Robert Tauxe (CDC), and Paul Kiecker (USDA)
FDA recently announced its intent to put technology innovation front and center as a priority with its New Era of Food Safety initiative. “This isn’t a tagline. It’s a pause and the need for us to once again to look to the future,” said Frank Yiannas, FDA’s deputy commissioner for food and policy response during an town hall at the Food Safety Summit. “The food system is changing around us dramatically. Everything is happening at an accelerated pace. The changes that are happening in the next 10 years will be so much more than [what happened] in the past 20 or 30 years…We have to try to keep up with the changes.” As part of this “new era”, the agency will focus on working with industry in the areas of digital technology in food traceability (“A lack of traceability is the Achilles heel of food,” said Yiannas), emerging technologies such as artificial intelligence and machine learning, and e-commerce. Yiannas said that FDA will be publishing a blueprint very soon to provide an idea of what areas will be the main focus of this initiative.
Thank you to everyone who participated in our latest FSMA IQ test, which focused on the supply chain. This series was developed by Kestrel Management. If you have any questions about the results, we encourage you to leave a comment.
We also invite you to learn more about important supply chain issues at our Food Safety Supply Chain Conference later this month, May 29–30. You can attend in person or virtually.
Control limits must be included within the hazard analysis and preventive controls for HACCP.
FALSE. More clarification is needed here, as 96% of respondents said this is true.
CCPs previously established under HACCP or previous hazard analysis may be a preventive control under FSMA.
TRUE. 91% got this right.
Product testing for pathogen or indicator organism is not addressed under FSMA verification and reevaluation.
FALSE. 87% answered correctly.
You must document justification of records not required by a food safety plan in a food operation under FSMA.
TRUE. Just 44% responded “true”.
You must implement corrective actions and corrections properly, including procedures to address the presence of organizations in ready-to-eat as a result of product testing.
TRUE. Congratulations, 100% got this one right!
Under section 117.150, you must implement corrective actions based on your determined response for all affected food as evaluated.
FALSE. This seems to be another area that needs clarity: Just 13% answered “false”.
Under FSMA supply chain requirements, you must document approved suppliers.
TRUE. Once again, great job—100% answered correctly!
A foreign supplier of food to the U.S. must ensure that all the requirements of a FSMA Food Safety Plan under cGMP117.126 be met for the manufacture of the food being exported to the United States.
TRUE. 91% knew this one.
A food broker of foreign-supplied product to the U.S. does not have any responsibility of meeting the FSMA requirements.
FALSE. 91% answered correctly.
Data sets must be shared between shippers, carriers, loaders & receivers to ensure rules are properly implemented.
TRUE. 74% answered correctly.
Only the personnel of the carriers transporting food product require training and training records.
FALSE. 96% got this one right.
Shipper & carrier can agree to a condition & temperature monitoring mechanism for foods that requires temperature control for safety.
“Simply put, the Food Safety Modernization Act (FSMA) means that it’s no longer acceptable to have a reactive food safety policy. There is a new emphasis on proactive measures to safeguard public health.
That said, whether your pest control is managed in-house, or you hire a professional pest management company, odds are “service” is focused on the rote practice of trap checking, which is neither cost-effective, nor does it provide the holistic IPM strategy that focuses on proactive inspections that ensure FSMA compliance.
You should be challenging your service provider, holding them to the standard of this new obligation. To understand the state of the industry and what food managers need to be considering when it comes to rodents, I contacted Richard Kammerling, founder of RK Pest Management Services, whose half-century of experience gives him a unique vantage on the hallmarks of an expertly managed food safety program – past, present and future.
Joe Barile: How would you characterize the current state of the industry?
Richard Kammerling: The food industry has a problem where they sometimes assume everything is fine even when it’s not. And sometimes they’re not willing to pay the price to make sure their program is working properly until they have a real problem. One of the biggest problems in the food industry is they underestimate the time that is needed to properly perform a pest management program. The food industry tends to be reactive rather than proactive. If they’re not given the information to know a condition could be or is an issue, then they don’t address it as such.
Barile: So, what should food managers be requiring from service providers?
Kammerling: Service providers should be acting as diagnosticians. Say, through trap-checking, we found one mouse in a trap. Is it only one mouse? Or is it an infestation? What are the conditions that caused it? Most of the pest control industry is going around the perimeters, but they’re not doing the entire scope of the food warehouse.
If you can find a pest-vulnerable condition and eliminate it, that’s the key to an effective IPM program. Collecting data can help you find some of these conditions, but analysis of that data and inspections are key to a pest management program – and that’s what food safety managers should be demanding of their pest managers, internal or external. Most pest control today is based on trap checking and does not leave enough time for inspections or data analysis….”
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