FDA

FDA Issues Letter to Industry Addressing Efforts to Reduce Chemical Hazards in Foods for Babies and Young Children

By Food Safety Tech Staff
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FDA

A report released last month by the Subcommittee on Economic and Consumer Policy revealed dangerous levels of toxic heavy metals in baby food. It stirred up quite a bit of controversy and concern, and raised questions over whether baby food manufacturers were hiding dangerous levels of toxic heavy metals in food, and whether FDA was doing enough to ensure the safety of food.

In an effort to assure the public that FDA is taking the issue seriously, the agency published a constituent update about its actions to further prevent or reduce toxic elements in foods for babies and young children. It also issued a letter to manufacturers and processors of baby and toddler foods as a reminder of the “responsibility under the rulemaking to consider chemical hazards that may be present in foods when conducting your hazard analysis,” which is part of the preventive control provisions of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food FSMA rule.

“FDA takes exposure to toxic elements in the food supply extremely seriously, especially when it comes to protecting the health and safety of the youngest and most vulnerable in the population. Toxic elements, such as arsenic and lead, are present in the environment and may enter the food supply through soil, water, or air,” stated CFSAN Director Susan Mayne in the letter. “Our goal is to reduce exposure to toxic elements in foods to the greatest extent feasible and to further advance progress in this area through more research and enhanced collaboration among stakeholders.”

The agency also stated that it is finalizing a plan to reduce levels of toxic elements in baby foods, including:

  • “Reviewing current action levels, as well as developing additional action levels, to help make food safer, including finalizing the arsenic in apple juice draft guidance and publishing a draft guidance with action levels for lead in juices.

  • Focused compliance and enforcement activities, including inspections.

  • Providing guidance to industry on how to meet their obligations under current regulations.”

The agency will also continue its surveillance sampling assignment that focuses on these products.

Figure 1. HorizonScan Overview

HorizonScan Hazard Challenge: Quiz 5

Figure 1. HorizonScan Overview

We may never know which came first, the chicken or the egg, but we’re going to look at both of them over the next two weeks. At the risk of inciting a philosophical debate, we are choosing to start with eggs. Did you know that production of eggs has more than doubled since 1990, with nearly 1.4 Trillion eggs being produced in 2018? That equates to over 175 eggs per human being per year. A problem in eggs could impact a lot of people!

Hazard Question #5 – Historically, Salmonella has been the most frequently reported issue in eggs, but from July through November 2017 another issue dominated the industry and triggered massive recalls, especially in Europe. What was it?

Hint: If you had access to HorizonScan you could find the answer in a matter of seconds by doing a search on eggs, entering the date range described above in the chart filter, then clicking on the #1 issue shown in the resulting bar chart. We’ll show you what that looks like next week when we provide the answer.

The good news is that according to HorizonScan, no inspection agency in the world has reported a recurrence of this issue since March of 2018, which suggests that even though it was pretty catastrophic when it happened back in 2017, it’s probably no longer an issue that you need to spend a lot of money and resources controlling. That’s the beauty of having access to the accurate data contained in HorizonScan: you can efficiently target your budget to focus on the issues that are genuine threats to the supply chain right now, and not waste your resources controlling issues that may no longer pose a significant threat, or being unaware of new issues that do.

To request updated pricing information or a free demo of HorizonScan, just reply now to this message and we’ll get back to you shortly and answer all your questions.

Kind regards,
The HorizonScan Team at FoodChain ID

Figure 1. HorizonScan Overview
Figure 1. HorizonScan Overview

Answer to last week’s Quiz – What are the most commonly reported hazards in Cashews, Macadamias and Pine Nuts?

While Aflatoxins are far and away the most commonly reported hazard in tree nuts as a group, Salmonella has historically been the most commonly reported issue for these three nuts. (See HorizonScan summary charts below.) The good news is that unlike Aflatoxins, Salmonella can easily be mitigated with a process control such as a thermal kill step.

Hazards in Cashews, Macadamian Nuts
Figure 2. Most commonly reported Hazards in Cashews, Macadamias and Pine Nuts
Kathy Wybourn, DNV-GL

Ask the Expert: Track and Trace–FDA FSMA Proposed Rule for Food Traceability

Kathy Wybourn, DNV-GL

Does the proposed rule apply to importers?

Kathleen Wybourn: Yes. The proposed rule will apply to all persons, who manufacture, process, pack, or hold foods on the FTL (foods on the Food Traceability List), which does include food importers, who engage in such activities. However, persons, who do not physically possess food, are not engaged in “holding” of food within the meaning of the proposed rule. This means that some persons, who import food, may not be subject to the rule, because they do not “hold” the food. As an example, a person, who coordinates the import of a listed food, but never takes physical possession of the food, would not be subject to the rule; while a person, who imports a listed food, and they physically possess it, would be subject to the rule, unless an exemption is applied.

Does the “one step forward and one step back” meet the requirements of the FDA FSMA Proposed Rule for Food Traceability?

Wybourn: No. The nearly 20-year-old requirement for tracing will not meet the new requirements of the new rule. The FDA’s proposed rule requires food and beverage companies to include the following records: a) companies should maintain a list that includes the description of all FTL foods shipped, along with a traceability product identifier; b) companies should also have a description of traceability reference records, and how different information is linked, such as purchase orders and bills of lading; c) companies must also develop traceability lot codes that identify the types of food at any point, when it is originated, created, or transformed.

Kathy Wybourn, DNV-GL
Kathy Wybourn, director of food & beverage, USA & Canada at DNV-GL

About Kathleen Wybourn, Director Food Safety, DNV GL North America

Kathleen began her career in food manufacturing at the NutraSweet Division of GD Searle/Monsanto where she held various managerial positions including managing analytical and microbiology labs, quality control, quality assurance, supplier audits and operations. Since leaving food manufacturing, Kathleen has worked in various food safety auditing management positions, including Director of Operations at the GMA as Director of the GMA SAFE program.

In 2008 Kathleen joined DNV as Director of Food Safety Solutions where she is responsible for the Food and Beverage division of DNV GL – Business Assurance. Kathleen has written articles on Food Safety Certification including: First Look: GFSI Adds New FSSC 22000 Standard, WAL-MART’s Magna Carta for Auditing, and Navigating the Jungle of Food Safety Standards – all published in various Food industry magazines. Kathleen was instrumental in the study conducted at Michigan State University on Food Safety Certification in the US titled “Food Safety in the U.S. Supply Chain – Consumer and Food Industry Perceptions.” Kathleen is very active with GFSI, having served on various Technical working groups and speaking at the GFSI Global Conferences.

Kathleen has a Bachelor of Science Degree from Northern Illinois University and an MBA from Loyola University of Chicago.

Content Sponsored by DNV.

HorizonScan

HorizonScan Hazard Challenge: Quiz 4

HorizonScan

No matter what your dietary preferences are – Vegan or Paleo on the one hand, or Snickers and Baby Ruth bars on the other – you’ve gotta love those nuts! Unfortunately, some of us are allergic to them. The presence of undeclared nuts in food products is a commonly reported issue in HorizonScan. But even for those who aren’t allergic to nuts, there are still plenty of things to worry about. The most commonly reported risk in both tree and ground nuts is excess levels of Aflatoxins, which can be very dangerous and health-threatening. But there are exceptions to this, and these are the subject of today’s quiz.

Hazard Question #4 – What are the most commonly reported hazards in Cashews, Macadamias and Pine Nuts?

Hint: It’s the same for all three, but it’s not Aflatoxins. And if you had HorizonScan you could know the answers in less than ten seconds each by simply entering each nut in the search tool, clicking a button and then viewing the hazard summary chart that pops up on the results page.

When it comes to analyzing hazards in nuts (or any food group) it’s not the case that “one size fits all.” Sometimes similar food products are susceptible to unique biological, chemical, or physical threats that need to be considered as part of your raw materials risk assessment. Stop wasting your time trying to identify supply chain hazards with Google searches or clunky government databases. With HorizonScan, all this information is right at your fingertips. It’s totally nuts how simple it is!

To request updated pricing information or a free demo, just reply now to this email and we’ll get back to you shortly and answer all your questions.

Kind regards,
The HorizonScan Team at FoodChain ID

Figure 1. HorizonScan Overview
Figure 1. HorizonScan Overview

Answer to last week’s Quiz – Which food category has had the most fraud incident reports over the past 20 years?

Most fraud is economically motivated so It should come as no surprise that Spices have historically been a favorite target of fraudsters since their high prices can make it quite lucrative to add a cheap filler or substitute a similar but inferior substance. Sometimes the impact of food fraud goes beyond pure economics and becomes a safety issue, too, as was the case in 2015 when ground up peanuts and shells were discovered in ground cumin, triggering a nationwide recall in the USA.

HorizonScan
Figure 2. Fraud Incident Reports by Category
2021 Food Safety Consortium

FDA to Take Questions in Advance of 2021 Food Safety Consortium

By Food Safety Tech Staff
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2021 Food Safety Consortium

This year’s Food Safety Consortium Virtual Conference Series kicks off on Thursday, May 6 with a keynote presentation from Frank Yiannas, FDA deputy commissioner for food policy and response. This year we are extending the Q&A period with Yiannas to 30 minutes, and we are providing attendees the opportunity to bring their questions to the top of the list by filling out the below form. We had a lot of questions during last year’s FDA Town Hall, and we’d love to be able to get to more of them this year.

The Spring Program will run every Thursday in May, with each episode starting at 12 pm ET. The weekly episodes will tackle a range of critical topics in foods safety, including FSMA and traceability, food protection strategies, COVID-19’s lasting impact on the food industry by segment, audits and supply chain management. Registration is open now.

Create your own user feedback survey

 

About the Food Safety Consortium Conference

The Food Safety Consortium is an educational and networking event for Food Protection that has food safety, food integrity and food defense as the foundation of the educational content of the program. With a unique focus on science, technology and compliance, the “Consortium” enables attendees to engage in sessions that are critical for advancing careers and organizations alike. Over the past 9 years the Food Safety Consortium has built a reputation for delivering the most knowledgeable and influential perspectives in food safety. The speaker line-up has driven key food safety decision-makers to the event (both in-person and virtually)—facilitating an environment for vendors, suppliers, food industry professionals, and consultants to network and build long-lasting business relationships.

Due to COVID-19, the 2020 Food Safety Consortium was converted to a virtual conference series that featured specific topics in a weekly episode series. The 2021 Food Safety Consortium Virtual Conference Series will feature a Spring and Fall program, running in May and October, respectively.

El Abuelito Cheese

Recall Alert: Listeria Outbreak Linked to Hispanic-Style Fresh and Soft Cheeses

By Food Safety Tech Staff
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El Abuelito Cheese

–UPDATE March 9, 2021 — Today the FDA confirmed that the recalled cheeses were also distributed to Rhode Island. “States with confirmed distribution now include: AL, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, NC, NJ, NY, NE, OH, PA, RI, SC, TN, VA, and WI.”

–UPDATE February 24, 2021 — FDA has expanded its warning related to El Abuelito Cheese to include all cheese branded by the company “until more information is known”.

—END UPDATE—

A multistate outbreak of Listeria monocytogenes has been linked to Hispanic-style fresh and soft cheeses produced by El Abuelito Cheese, Inc. As a result, the company has recalled all Questo Fresco products with sell by dates through March 28 (032821).

Join Food Safety Tech on April 15 for the complimentary Food Safety Hazards Series: Listeria Detection, Mitigation, Control & Regulation“As the FDA stated, about this outbreak investigation, the Connecticut Department of Public Health collected product samples of El Abuelito-brand Hispanic-style fresh and soft cheeses from a store where a sick person bought cheeses. Sample analysis showed the presence of Listeria monocytogenes in samples of El Abuelito Queso Fresco sold in 10 oz packages, marked as Lot A027 with an expiration date of 02/26/2021,” the company stated in an announcement posted on FDA’s website. “Samples are currently undergoing Whole Genome Sequencing (WGS) analysis to determine if the Listeria monocytogenes found in these samples is a match to the outbreak strain. At this time, there is not enough evidence to determine if this outbreak is linked to El Abuelito Queso Fresco.”.

The recalled products were distributed to Connecticut, Maryland, New Jersey, North Carolina, New York, Pennsylvania and Virginia. Thus far seven people, all of whom have been hospitalized, have fallen ill.

FDA recommends that consumers, restaurants and retailers do not consume, sell or serve any of the recalled cheeses. The agency also states that anyone who purchased of received the recalled products use “extra vigilance in cleaning and sanitizing any surfaces and containers that may have come in contact with these products to reduce the risk of cross-contamination.”

FDA

FDA Responds to Subcommittee Report on Toxic Metals in Baby Food

By Food Safety Tech Staff
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FDA

Following a report released nearly two weeks ago about the potential danger posed by toxic heavy metals found in baby foods manufactured by several major companies, FDA has issued a response. The report, “Baby Foods Are Tainted with Dangerous Levels of Arsenic, Lead, Cadmium, and Mercury”, was released by the U.S. House of Representatives Committee on Oversight and Reform Subcommittee on Economic and Consumer Policy on February 4. The Subcommittee stated that FDA should require baby food manufacturers to test their finished products for toxic heavy metals and require any toxic heavy metals be reported on food labeling. It also stated that FDA should set maximum levels of toxic heavy metals allowed in baby foods.

“The FDA has been actively working on this issue using a risk-based approach to prioritize and target the agency’s efforts. Consumers should know that FDA scientists routinely monitor levels of toxic elements in baby foods, along with other foods consumed in the country’s diet, through the Total Diet Study,” the agency stated in a CFSAN update. “Further, the FDA also monitors baby food under the FDA’s compliance program for Toxic Elements in Food and Foodware, and Radionuclides in Food and through targeted sampling assignments.”

FDA cited its work in sampling infant rice cereal for arsenic, which it says has resulted in safer products on the market, along with its recent court order to stop a U.S. company from distributing adulterated juice that had potentially harmful levels of inorganic arsenic and patulin (a mycotoxin).

The CFSAN update, however, did not specifically address the companies or baby foods called out in the Subcommittee’s report.

Bretty Gray, DNV

Ask the Expert: What Is Blockchain for the Food Supply Chain—Explained Simply

Bretty Gray, DNV

Why do we need traceability solutions for the supply chain?

Brett Gray: Supply chains changed from a linear model to more like ecosystems. Raw materials and ingredients are traveling from multiple sources multiple times, and you are no longer relying on a single supplier, but, rather, on a large number of suppliers and an entire new network of people, who enable you to accomplish the objectives for your business. These new ecosystems have made things more complex, and forced companies to change their business models, forming multiple relationships, thus storing data in multiple locations. As a result, consumer trust has shifted from known brands to products. With multiple sourcing of raw materials or ingredients by [previously] trusted producers, consumers want to know, how these ingredients were grown, transported and stored. Consumers are looking now at the labels, rather than logos. While consumers are asking for proofs of origin, quality, social responsibility and sustainability, brands are struggling to share about all efforts and investments made into specific products, as well as create engaging for this or that group of consumers touch points.

So, how is this technology – blockchain – appeared to be best suitable to fulfill the current market requirements for the proof of products origins for the end consumer?

Gray: Blockchain is a decentralized (no single ownership), distributed ledger-like digital structure that allows a community to record, share and maintain information. The documents are like IDs we know: A passport or a driving license, except these are for products. These documents are protected by encryption from being modified and irreversibly time stamped. Each document in the blockchain is connected to the previously produced one and the one produced after, so it forms a chain of blocked documents. Blockchain technology acts as a perfect trust generator for different types of businesses. The authenticity of data in it renders trust among stakeholders previously unknown to each other.

DNV GL started developing its My Story blockchain based solution about a decade ago, when this technology was not well known. Now it enables companies to prove that their “marketing buzzwords” are, in fact, true, verified statements. For companies seriously investing in sustainable processes and value chains, it enables sharing about these efforts directly with the end consumer, setting such companies apart from less serious, greenwashing players.

About Brett Gray

As the Digital Transformation Manager at DNV, I oversee all digital projects, strategy, and solution for the entire region of North America, with the intention of bringing technology stacks and other emerging technologies like blockchain, AR/VR, artificial intelligence and big data analytics to change the way we interact with and provide services to our customers.

Content Sponsored by DNV.

FDA

FDA Begins Phase Two of Artificial Intelligence Imported Seafood Pilot Program

By Food Safety Tech Staff
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FDA

FDA is beginning phase two of its Artificial Intelligence Imported Seafood Pilot Program. The program, which is expected to run from February 1 through July 31, intends to improve FDA’s response in quickly and efficiently identifying potentially harmful imported seafood products.

Phase one of the pilot looked at using machine learning to find violative seafood shipments. “The pilot program will help the agency not only gain valuable experience with new powerful AI-enabled technology but also add to the tools used to determine compliance with regulatory requirements and speed up detection of public health threats,” FDA stated in a news release. “Following completion of the pilot, FDA will communicate on our findings to promote transparency and facilitate dialogue on how new and emerging technologies can be harnessed to solve complex public health challenges.”

The pilot program is part of the agency’s efforts that fall under the New Era of Smarter Food Safety.

Select Subcommittee on the Coronavirus Crisis

OSHA, Tyson, Smithfield and JBS Under Investigation for COVID Outbreaks

By Food Safety Tech Staff
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Select Subcommittee on the Coronavirus Crisis

Last week U.S. Congressman and chairman of the Select Subcommittee on the Coronavirus Crisis James E. Clyburn (D-SC) launched an investigation into OSHA, Tyson Foods, Smithfield Foods and JBS USA over the nationwide coronavirus outbreaks at meatpacking plants that have led to the deaths of at least 270 employees. Nearly 54,000 workers at 569 U.S. meatpacking plants have tested positive for COVID-19, according to the Subcommittee and media reports.

Select Subcommittee on the Coronavirus Crisis“Public reports indicate that under the Trump Administration, the Occupational Safety and Health Administration (OSHA) failed to adequately carry out its responsibility for enforcing worker safety laws at meatpacking plants across the country, resulting in preventable infections and deaths. It is imperative that the previous Administration’s shortcomings are swiftly identified and rectified to save lives in the months before coronavirus vaccinations are available for all Americans,” the letter to James Frederick, deputy assistant secretary of labor for OSHA stated. “The Select Subcommittee strongly encourages you to take all necessary steps, including under President Biden’s Executive Order on Protecting Worker Health and Safety1and your other existing statutory authorities, to protect workers from the risks of the coronavirus by issuing clear guidance to employers, enacting an emergency temporary standard, and enhancing enforcement efforts.”

Clyburn and the Subcommittee issued a letter to Dean Banks, president and CEO of Tyson Foods, Dennis Organ, president and CEO of Smithfield Foods, and Andre Nogueira, president and CEO of JBS USA. Each letter pointed out the shortcomings of each company in adequately addressing the outbreaks that occurred among its workers.

“Public reports indicate that meatpacking companies … have refused to take basic precautions to protect their workers, many of whom earn extremely low wages and lack adequate paid leave, and have shown a callous disregard for workers’ health,” Clyburn stated in the letter. “These actions appear to have resulted in thousands of meatpacking workers getting infected with the virus and hundreds dying. Outbreaks at meatpacking plants have also spread to surrounding communities, killing many more Americans.”

The Subcommittee has asked OSHA and each company for documentation related to the COVID infections and deaths, as well as their enforcement of worker protections under the Trump administration.