Tag Archives: FDA

FDA

FDA Sampling of Romaine Lettuce in Yuma Finds No Widespread STEC or Salmonella Contamination

By Food Safety Tech Staff
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FDA

Following last year’s widespread E.coli O157 outbreak involving romaine lettuce linked to the Yuma, Arizona growing region (Spring 2018), FDA launched a sampling assignment to test romaine lettuce for pathogenic Shiga toxin-producing Escherichia coli (STEC) and Salmonella spp. The microbiological surveillance sampling began on December 18, 2018 in the Yuma region and focused on 26 commercial coolers and cold storage facilities to allow FDA to sample multiple farms from several locations at once. The agency collected and tested a total of 188 samples for both pathogens. It did not detect Salmonella in any sample; STEC was detected in one sample, but additional analysis found that the bacteria was not pathogenic.

“The findings of this assignment suggest that there was no widespread Salmonella or STEC contamination of romaine lettuce from the Yuma growing region during the period when sampling occurred. As a next step, the FDA is working with leafy green stakeholders in the Yuma region to consider a longer-term environmental study to identify and control risks that will prevent future outbreaks, with the ultimate goal of protecting consumers. – FDA

The point of the sampling assignment was to determine whether target pathogens were present, and if so, to respond quickly before contaminated products reached consumers.

Lab grown meat

“Real” Beef: It May Not Be What’s For Dinner Anymore

By Maria Fontanazza
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Lab grown meat

As the consumer craze over plant-based meat continues, cell-cultured meat is next on the list of alternatives to “real meat”. There are several factors driving this market, including increased demand for meat as the world’s population grows and becomes more affluent, and the concern that if more sustainable solutions are not implemented, there won’t be enough protein to feed the world’s population by 2050, according to Paul Mozdziak, professor at NC State University. Mozdziak, who presented his perspective on cell-cultured meat during the IAFP Annual Meeting last month, has been working in the cell-cultured meat space for 25 years. It’s not a new concept, he pointed out, but sustainability issues, concerns over the efficiency of the animal industry (i.e., the biological limits of animals), along with a waning enthusiasm in eating animals have sparked even more interest in animal technologies during the past few years.

Animal cell culture technology involves a controlled growth of animal cells from livestock, poultry, fish or other animals, their subsequent differentiation into various cells types, and their collection and processing into food, according to Roberta Wagner, assistant administrator, Office of Policy and Program Development at FSIS, USDA. Wagner shared the regulatory perspective on this emerging segment at IAFP. And although the session in which Wagner and Mozdziak spoke was titled, “Is Cell-cultured Meat Really Meat?”, neither of them answered this question. Rather, they discussed the status of the sector and the challenges ahead.

Scale Up

“The technology has been around,” said Mozdziak. “The issue is getting it to scale and myogenic to actually produce product.” Muscle cells want to attach to something. The process of making cultured meat involves isolating cells, getting them to grow in suspension and transferring them to a bioreactor to grow. In order to create a fully formed muscle, the cells needs to attach to a scaffold and differentiate, he explained. The bioreactor facilitates a sterile environment, but when scaling up, the challenge is the unknowns (which could introduce food safety issues) during downstream processing. “Once it’s out of the bioreactor and in a non-sterile environment, there are a variety of ways it can be contaminated,” said Mozdziak.

The production process could be cost prohibitive as well. “Currently, serum-based media cost $25 a liter; serum-free is $104 a liter. How much lower can we go from that?” said Mozdziak. “A kilo of turkey at ALDI is $6… therefore the media costs would have to be below $12 a liter for this to ever be profitable.”

How Will It Be Regulated?

In October 2018, FSIS and FDA held a joint public meeting to discuss the use of cell culture technology to develop products derived from livestock and poultry. The agencies also started talking about what regulatory oversight might look like. In March of this year the USDA and FDA reached a formal agreement on joint framework for regulating cell-cultured meat and poultry products. FDA will regulate the extraction of cells from live animals and jurisdiction will be transferred to FSIS during the cell harvest stage, and FSIS will oversee production and labeling. “The agreement roughly mirrors our jurisdiction of both agencies for traditionally produced livestock,” said Wagner. She added that regarding FSIS authority over cell-cultured products, the agency does not expect there will be a need for additional legislation nor will there be new regulation to inspect the products (Establishments that harvest cells or process the cells must comply with sanitation, HACCP and any other applicable FSIS regulations). Labeling for cell-cultured meat and poultry products must be approved.

Wagner noted two major challenges ahead in the federal regulation of cell-cultured meat. “We’ve received very little information about the process and technology being developed or used by cell-cultured meat and poultry manufacturers,” she said. “If industry doesn’t share such information, there could be a delay in review of products.” She added that the agency is encouraging industry to come forward sooner than later with this information. The second big challenge involves research and science gaps—more is needed to understand the risks.

So, is cell-cultured meat really meat? “Before we can answer that, someone needs to actually have a product,” said Mozdziak. He believes industry will get there in creating marketable cell-cultured meat, but there is no telling how long it will take.

Northfork Buffalo Burgers, recall

Possible E. Coli Contamination in Ground Bison, Recall Issued

By Food Safety Tech Staff
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Northfork Buffalo Burgers, recall

Northfork Bison Distributions, Inc. has issue a voluntary recall of its Bison Ground and Bison/Buffalo Burgers following a multistate outbreak of E. coli O121 and E. coli O103 linked to its ground bison. The ground bison was produced between February 22, 2019 and April 30, 2019, and has expiration dates through October 8, 2020.

Thus far, 21 people have become ill, and eight have been hospitalized, with cases reported in Connecticut, Florida, Mississippi, Missouri, New Jersey, New York and Pennsylvania.

The FDA regulates bison meat, as the authority is not assigned to USDA’s FSIS. Several images of the affected products have been posted on the agency’s website.

During the investigation, the FDA and CDC used traceback and epidemiological information to link to affected ground bison to Northfork Bison, which the agency noted was quick to initiate the recall.

2019 Food Safety Consortium Conference & Expo

Mark Your Calendars: 2019 Food Safety Consortium Includes Panels on Recalls, Food Defense and Supply Chain Transparency

By Maria Fontanazza
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2019 Food Safety Consortium Conference & Expo

The 2019 Food Safety Consortium Conference & Expo kicks off on Tuesday, October 1 and is packed with two-and-a-half days of informative sessions on a variety of topics that are critical to the food safety industry. We invite you to check out the full agenda on the event website, but below are several event highlights that you should plan on attending.

  • Opening Keynote: Frank Yiannas, Deputy Commissioner for Food Policy and Response, FDA
  • Recalls Panel Discussion: Led by Rob Mommsen, Director of Global Quality & Food Safety, Sabra Dipping Company
  • Food Defense Panel: Led by Steven Sklare, REHS, CP-FS, LEHP. Invited Panelists include Jason P. Bashura, MPH, RS, Sr. Mgr., Global Food Defense, PepsiCo and Jill Hoffman, Director, Global Quality Systems and Food Safety at McCormick & Company and Clint Fairow, M.S. Global Food Defense Manager, Archer Daniels Midland Company
  • “Validation Considerations and Regulations for Processing Technologies”: General Session presented by Glenn Black, Ph.D., Associate Director for Research, Division of Food Processing Science and Technology (DFPST), Office of Food Safety (OFS), CFSAN, FDA
  • “Food Safety Leadership: Earning respect – real-life examples of earning and maintaining influence as a Food Safety leader”: Panel Discussion moderated by Bob Pudlock, President, Gulf Stream Search
  • Supply Chain Transparency Panel Discussion: Led by Jeanne Duckett of Avery Dennison
  • Taking an Aggressive Approach to Sanitation: Planning for a Contamination Event: Presented by Elise Forward, President, Forward Food Safety
  • Three Breakout Tracks: Food Safety Leadership; Food Testing & Analysis and Sanitation and Operations

Register by September 13, 2019 for a special discount!

Frank Yiannas, VP of Food Safety, Walmart
Watch this video from when Frank Yiannas was the vice president of food safety at Walmart. He presented at the 2015 Food Safety Consortium.

Steven Sklare, USP, Aaron Biros, Food Safety Tech
Watch this video of Steven Sklare speaking with Aaron Biros of Cannabis Industry Journal at the 2017 Food Safety Consortium.

Bob Pudlock, Gulf Stream Search
Read Bob Pudlock’s exclusive series on Food Safety Tech, Architect the Perfect Food Safety Team.

Elise Forward, Forward Food Solutions
Elise Forward discusses how to take food defense beyond the four walls of your business.
Food Safety Consortium - October 1-3, 2019 - Schaumburg, IL

Food Safety Consortium Early Bird Discount Expires This Week

By Food Safety Tech Staff
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Food Safety Consortium - October 1-3, 2019 - Schaumburg, IL

View the range of content associated with the Food Safety ConsortiumThe 2019 Food Safety Consortium Conference & Expo attracts some of the most influential stakeholders in the industry. This year’s event, which runs October 1–3, will not disappoint, with several features that provide a maximum networking and educational benefit to attendees.

The following is a snapshot of just a few of the benefits of attending this year’s Food Safety Consortium:

  • The Food Defense Consortium Meeting. This pre-conference workshop is open to all participants of the Food Safety Consortium
  • FSSC 22000 North American Information Day. This pre-conference workshop takes place on the morning of Tuesday, October 1 and is open to all Food Safety Consortium participants
  • A complimentary Sanitation Pre-conference Workshop (Tuesday, October 1)
  • Keynote Plenary Session by Frank Yiannas, FDA deputy commissioner for food policy and response
  • Recalls panel led by Rob Mommsen, director of global quality & food safety, Sabra Dipping Company
  • Food defense panel led by Steven Sklare, president of The Food Safety Academy; participants include Jason Bashura, senior manager of global food defense at PepsiCo
  • Focused breakout tracks on food safety leadership, food testing & analysis, and sanitation and operations

Don’t miss the opportunity to have access to the premier industry event at a significant value. The super early bird discount expires this Friday, June 28.

King Arthur Flour, E.coli, Recall

ADM Milling Recall Extends to King Arthur Flour, Voluntary Recall Issued

By Food Safety Tech Staff
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King Arthur Flour, E.coli, Recall
King Arthur Flour, E.coli, Recall
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.

Thus far, the investigation of E.coli O26 involving ADM Milling Flour has been linked to 17 illnesses and three hospitalizations.

magnifying glass

Failure to Have Foreign Supplier Verification Plan a Common Inspection Observation

By Maria Fontanazza
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magnifying glass

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 FY 2017 285
Risk-based (hazards, importers and suppliers) FY 2018 792
Align with PC supply chain provisions FY 2019 (as of 5/28/19) 458 (FDA is planning for 880)
FDA oversees compliance via importer inspection
Foreign suppliers can help importers comply

 

Recall

ADM Milling Expands ALDI Flour Recall Due to E. Coli Concern

By Food Safety Tech Staff
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Recall

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.

Mitzi Baum, Stop Foodborne Illness
Food Safety Culture Club

Building a Safer Supply Chain, Increasing Foodborne Illness Awareness, and Progress in Sustainability: A Q&A with Stop’s New CEO

By Maria Fontanazza
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Mitzi Baum, Stop Foodborne Illness

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, Stop Foodborne Illness
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.

Frank Yiannas, FDA, Food Safety Summit, Food Safety Tech

Can We Make Progress Before the Next Food Safety Crisis?

By Maria Fontanazza
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Frank Yiannas, FDA, Food Safety Summit, Food Safety Tech

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, FDA, Food Safety Summit, Food Safety Tech
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.