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.
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
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.
Last week Stop Foodborne Illness announced who would be filling the role of its retiring CEO Deirdre Schlunegger: Mitzi Baum. Previously managing director of food safety at Feeding America, Baum has extensive experience in the non-profit space as well as the realm of retail management. In a Q&A with Food Safety Tech, Baum discusses where she sees Stop Foodborne Illness moving forward in its advocacy role and how the organization will work with both industry as well as consumers in the future.
“I am excited to assume the role of CEO at Stop Foodborne Illness. We are at a point in our evolution to identify new opportunities to expand awareness, create a strategy to pursue those new opportunities and implement and execute our plan,” says Baum. “You will be hearing a lot from Stop in the near future.”
Food Safety Tech: You bring a tremendous amount of experience to your new role at Stop Foodborne Illness. How will the organization work with industry to advocate for food safety moving forward?
Mitzi Baum: In my previous position, I had the opportunity to build relationships, network with food safety peers in food manufacturing and retail and work on food safety issues. I would like to use that experience to our advantage as we identify new ways to work cooperatively with industry to move toward a safer supply chain and expand foodborne illness education and awareness throughout the food system. Stop has also fostered many relationships over the years; now we would like to translate those relationships into partnerships to affect greater impact and reduce the incidence of foodborne illnesses.
FST: Where are the key areas in which Stop will be focusing in its continued effort to both promote awareness of foodborne illness as well as prevention?
Baum: Moving forward, we will build upon relationships to promote awareness of foodborne illness prevention. Currently, we have 10 industry partners working with Stop to identify new training techniques to increase awareness of the impact of foodborne illnesses. In the next few months, we will run pilots to test the techniques, gather data, make adjustments and reassess. After the pilot phase, we will work with an expanding number of companies to implement an appropriate model that will result in measurable improvements for internal foodborne illness awareness.
Mitzi Baum, CEO, Stop Foodborne Illness
FST: Given your experience in food insecurity, where do you see the most progress in addressing sustainability? Where is there work do be done?
Baum: There has been a lot of progress regarding increased awareness of sustainability and reduction of wasted food. Sustainability is an essential part of the food industry and there has been little to no discussion about the topic until the past few years. Thankfully, it has become a badge of honor for companies to include sustainability into their organizational culture. With a pivot to focus on sustainability, topics such as utilization of natural resources, types of packaging materials and long-term environmental impact have become the focus for an industry that can be a model for other industries.
With regard to food waste, the new cooperative initiative between USDA, EPA and FDA can certainly help to accelerate impact. It is my hope that the regulatory agencies can work to modify regulations that prohibit the donation of safe, wholesome foods that end up in landfill rather than on the dinner table. The amount of wasted food in this country is shameful.
FST: As FDA steps into its “New Era of Smarter Food Safety”, will Stop Foodborne Illness be collaborating with the agency on any new/current initiatives?
Baum: Absolutely. We want to participate and represent our constituents in this important work. Stop’s expertise and consumer-focused perspective is essential to have at the table. As the FDA plan rolls out, Stop will be identify the appropriate opportunities to assert its influence and continue to advocate for sound food safety policy.
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.
Records involving fraud can be found in the Food Fraud Database. Image credit: Susanne Kuehne
Pentobarbital-adulterated products were distributed to pet food manufacturers by a company in spite of receiving a formal notification letter from the FDA. Even a trace amount of this drug makes pet food “adulterated” according to the FDA; in this case the levels of the drug found were quite high. The affected company undertook some corrective measures but was unable to avoid the contamination. However, the company is now supposed to notify the FDA about specific steps regarding sufficient corrective actions within 15 days of receiving the warning letter.
One of the Tyson products involved in the recall. FSIS has provided a list of all the labels on its website.
Over the weekend Tyson Foods, Inc. announced an expanded voluntary recall of its frozen, ready-to-eat chicken strips due to more issues involving contamination with metal fragments. The initial recall occurred on March 21 and involved 69,093 pounds of product. All RTE chicken strips under the Class I recall have the establishment number “P-7221” on the product package and were produced between October 1, 2018 and March 2019, with “Use By Dates” of October 1, 2019 through March 7, 2020. The products were shipped nationwide to retail and Department of Defense locations, as well as to the U.S. Virgin Islands.
“Our company is taking corrective action at the location that makes these products. We have discontinued use of the specific equipment believed to be associated with the metal fragments, and we will be installing metal-detecting X-ray machinery to replace the plant’s existing metal-detection system. We will also be using a third-party video auditing system for metal-detection verification,” said Barbara Masters, DVM, vice president of regulatory food policy, food and agriculture for Tyson Foods in a company news release.
Thus far there have been six consumer complaints involving metals pieces, with three people claiming oral injury.
“It’s time to look to the future of food safety once again,” declared Acting FDA Commissioner Ned Sharpless, M.D. and Deputy Commissioner for Food Policy and Response Frank Yiannas in a press statement released yesterday. Although progress has been made in implementing FSMA and with the development of the GenomeTrakr Network, the agency wants to move forward in taking advantage of the innovative technologies that will help make the food supply more digital, traceable and safer. With that effort comes the creation of a “Blueprint for a New Era of Smarter Food Safety”, which will speak to “traceability, digital technologies and evolving food business models”. Sharpless and Yiannas outlined the significant role that these components will play.
Digital technology in food traceability. Digital technologies could play a crucial part in rapidly identifying and tracing contaminated food back to its origin—changing the timespan from days or weeks to minutes or seconds. FDA intends to look at new ways that it can evaluate new technologies and improve its ability to quickly track and trace food throughout the supply chain. “Access to information during an outbreak about the origin of contaminated food will help us conduct more timely root cause analysis and apply these learnings to prevent future incidents from happening in the first place,” stated Sharpless and Yiannas. This means a shift away from paper-based systems.
(left to right) Ned Sharpless, M.D., FDA acting commissioner and Frank Yiannas, deputy commissioner of food policy and response. Image courtesy of FDA
Emerging technologies. Artificial intelligence (AI), distributed ledgers (no, they didn’t directly say “blockchain”), the Internet of Things, sensors and other emerging technologies could enable more transparency within the supply chain as well as consumer side of things. The FDA leaders announced a pilot program that will use AI and machine learning to assess food imports at the U.S. point of entry.
E-Commerce. “Evolving food business models”, also known as e-commerce, is growing fast and changing how consumers get their food. With food delivery introduces food safety issues such as those related to packaging and temperature control. FDA is exploring how it can collaborate with federal, state and local stakeholders to figure out ways to address these potential problems.
Sharpless and Yiannas emphasized the end-goal in keeping the food of American consumers safe. “So, welcome to the new era of smarter food safety that is people-led, FSMA-based and technology-enabled!”
2018 Recap: As VQIP implementation began, confusion among the accreditation bodies (ABs) and certification bodies (CBs) was clearly evident, and options for explanations from FDA were limited. To facilitate information sharing, AFSAP hosted an open gathering of all interested parties to hear from FDA. The inaugural AFSAP Auditing Stakeholders meeting provided a unique opportunity for the auditing community at large to interact with FDA and expand their knowledge on the regulatory use of audits in FSMA. CB attendees gained valuable insight into their hybrid role as part Scheme Owner under the Third-Party Certification Program (TPP) and its operational challenges in the global community. After vigorous discussion, the development of a consensus program for FDA’s TPP audits emerged, although the definitive mechanism to achieve this objective was still to be determined. AFSAP established a membership category for CB’s, and has continued to pursue solutions to these and other audit related issues, but information sharing has been limited to members.
2019: Although progress has been made, there is still a need for information sharing among all interested parties. Once again, the 2nd Auditing Stakeholders Meeting will be co-located with the Food Safety Supply Chain Conference in Rockville, MD, May 29–30, 2019.
AFSAP extends a gracious thank you to them for supporting AFSAP’s mission and goals.
The 2019 Auditing Stakeholder meeting will build on the TPP knowledge base, incorporating other areas that overlap with auditing and auditor development in general. FDA has a new TPP management team participating this year, along with some familiar faces from 2018. Join AFSAP in welcoming them to our event!
We have an exciting agenda planned for this year that includes a members-only session, an at-large session, and updates from FDA’s new TPP team. Association announcements will be provided after the Association’s members meeting has concluded.
AFSAP Membership Meeting
Association updates; Accomplishments, Partnerships & Alliances, Plans and Activities
Committee Updates
The Auditor Development Committee/Chair introductions
AFSAP’s Voluntary Consensus Standard (VCS) for FDA’s 3rd Party Audit
VCS Board: Introductions and Nominations
The review and publication process for a VCS
Auditing Community Meeting Highlights
SGS’ Hank Karayan
The Accreditation Experience – Lessons Learned
Just the FAQ’s – Common questions and misconceptions
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 the Food Safety Supply Chain Conference
A food company’s supply chain can be the weakest link in their food safety program. Food ingredient adulteration, fraud, and counterfeiting negatively impacts everyone in the food supply chain. FDA has recognized the risk in the food supply chain. Sanitary transportation and the Foreign Supplier Verification Program (FSVP) are major components of FSMA. The Food Safety Supply Chain Conference addresses best practices, and new tools and technologies that can help food companies, including manufacturers, retailers and food service companies protect their brands and customers from food safety threats in their supply chain while being compliant with regulators.
Learn more about food fraud at the Food Labs Conference | June 2–4, 2020 | Rockville, MDThis week FDA made an announcement during a public meeting that the agency’s routine inspection to verify compliance with the FSMA Intentional Adulteration rule will start next March.
The first compliance date for the rule is this July. It is a requirement for food facilities covered under this rule to develop and implement a food defense plan that identifies vulnerabilities and the consequent mitigation plan.
FDA stated that it has received feedback on the “novel nature” of the rule’s requirements and that stakeholders want more time to develop their food defense plans. “ To allow industry time with the forthcoming materials, tools, and trainings, and because the IA rule represents new regulatory territory for all of us, we will be starting routine IA rule inspections in March 2020,” FDA stated and added that it is working on developing more resources as well as the final part of draft guidance to continue to assist industry.
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