Tag Archives: FDA

FDA

FDA Wants to Change Agricultural Water Requirements in Produce Safety Rule

By Food Safety Tech Staff
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FDA

After years of foodborne illness outbreaks that have been suspected to originate in pre-harvest agricultural water, FDA is proposing changes to the FSMA Produce Safety Rule. The proposed rule would revise subpart E, changing certain pre-harvest agricultural water requirements for covered produce other than sprouts.

“There have been far too many foodborne illness outbreaks possibly linked to pre-harvest agricultural water in recent years, including water coming from lands nearby produce farms. As a federal government agency charged with protecting public health, the FDA is committed to implementing effective modern, science-based measures designed to prevent these outbreaks from occurring in the future,” said Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response in an agency update. “The proposed rule is the latest action taken by the FDA to continue working towards implementation of key provisions of FSMA. If finalized, we’re confident this proposal would result in fewer outbreaks in the U.S. related to produce, protecting public health and saving lives. This proposed rule is a monumental step towards further improving the safety of the fruits and vegetables Americans serve their families every day, and the FDA looks forward to engaging with stakeholders on the proposed changes.”

Under the proposed rule, farms would be required to conduct yearly systems-based agricultural water assessments to assess and guide measures that would reduce risks related to pre-harvest agricultural water. According to the FDA, the assessment would consist of evaluating the water system, agricultural water use practices, crop characteristics, environmental conditions, potential impacts on source water by activities conducted on adjacent and nearby land.

With the current agricultural water compliance dates for covered produce other than sprouts set to begin in January 2022, the FDA plans to exercise enforcement discretion for those requirements while also proposing another rule that extends the compliance dates for all agricultural water requirements under the Produce Safety Rule.

The full details of the FSMA Proposed Rule on Agricultural Water are available on FDA’s website.

FDA

FDA Publishes Long-Awaited Final Rule on Lab Accreditation

By Food Safety Tech Staff
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FDA

At long last FDA has issued its final rule for Laboratory Accreditation for Analyses of Foods (LAAF). The FSMA rule establishes a lab accreditation program for testing food in certain situations and applies only to accredited bodies and food testing labs that opt to participate in the program; these ABs and labs must fulfill certain eligibility requirements.

“The establishment of the LAAF program will improve the FDA’s capacity to protect U.S. consumers from unsafe food by improving the accuracy and reliability of certain food testing through the uniformity of standards and enhanced oversight of participating laboratories,” CFSAN states in a news release.

According to CFSAN, the LAAF will apply to testing that is:

  • “to support removal of a food from an import alert through successful consecutive testing requirements;
  • to support admission of an imported food detained at the border because it is or appears to be in violation of the Federal Food, Drug, and Cosmetic Act;
  • required by existing FDA food safety regulations, when applied to address an identified or suspected food safety problem (i.e., certain tests of shell eggs, sprouts, and bottled drinking water);
  • required by a directed food laboratory order, a new procedure being implemented in this final rule that will allow the FDA to require use of a LAAF-accredited laboratory to address an identified or suspected food safety problem in certain, rare circumstances; and
  • conducted in connection with certain administrative processes such as testing submitted in connection with an appeal of an administrative detention order.”

The final rule will be published on the Federal Register on December 3.

Recall

Q3 Food Recalls Drop More than 10%, 2021 Could See Lowest Recall Levels in a Decade

By Maria Fontanazza
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Recall

FDA food recalls fell more than 11% and USDA recalls increased by just one recall in Q3. If this decreased activity continues, 2021 food recalls could fall to their lowest levels in more than a decade.

The drop in recalls is good news, but food companies remain challenged in maintaining and implementing effective employee training. “Health and safety risks related to the coronavirus, combined with labor shortages, mean that companies must double down on training, communication, and accountability, particularly in cases where employees have never worked in food manufacturing,” according to Sedgwick’s Q3 update on U.S. recalls. “All the right protocols and procedures can be in place, but without a skilled workforce and commitment to continuous improvement, no number of written policies and procedures will prove effective. Companies and their quality and safety teams must be ready, willing, and able to embrace new technologies and evolve with new regulatory guidance as the industry innovates.”

FDA Recalls: Notable Numbers (Q3 2021)

  • Recall activity dropped from 106 recalls in Q2 to 94 recalls (11.3% decline)
  • Prepared foods and produce were top categories for recalls, with 13 events each
  • Recalls affected 2.4 million units, a nearly 70% drop from Q2 (7.9 million units)
  • 33% of recalls were Class I
  • Undeclared allergens was leading cause of recall, with milk being the main cause
  • Bacterial contamination came in second for amount of recalls at 25, followed by quality concerns at 11 recalls

USDA Recalls: Notable Numbers (Q3 2021)

  • Recalls increased from 12 to 13 events (quarter-over-quarter)
  • Number of pounds increased from 207,000 pounds to 10.7 million pounds (due to a single recall of ready-to-eat poultry products that affected almost 9 million pounds)
  • Bacterial contamination was the top cause of recalls—Listeria, Salmonella, and E.coli were the named pathogens of concern
  • Eight recalls were due to undeclared allergens
  • Poultry products the most impacted product category

In November alone, there were nine recalls as a result of foreign matter contamination. Learn more about the strategies companies should implement to prevent and detect foreign materials during Food Safety Tech’s upcoming virtual event, “Food Safety Hazards: Physical Hazards”. | Thursday, December 16 at 12 pm ET.

Robert Califf, FDA

President Biden to Make Nomination for FDA Commissioner and USDA Food Safety Head

By Food Safety Tech Staff
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Robert Califf, FDA

President Biden plans to nominate former FDA Commissioner Robert Califf, M.D. to lead the agency once again—in an announcement mainly focused on clinical trials, vaccine approvals, and ending the coronavirus pandemic. Califf briefly served as FDA commissioner in 2016. His tenure was less than a year.

Perhaps more significant news for the food industry is the President’s intent to nominate Jose Emilio Esteban, Ph.D. to the post of undersecretary for food safety at the USDA. Esteban is currently the chief scientist for FSIS and has been in this role since 2018; he has served in the USDA’s FSIS since 2006. Before his time at the agency, he worked for the CDC.

The Senate must confirm both positions.

FDA

Online Food Shopping Becomes New Normal for Consumers, FDA to Ramp Up Food Safety Efforts

By Food Safety Tech Staff
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FDA

Online grocery shopping became essential during the early months of the COVID-19 pandemic. While many consumers have returned to the brick and mortar stores, many others have completely changed how they shop for food, opting for online shopping, whether out of convenience or for safety. The FDA has seen and recognizes this shift and even held a three-day virtual summit last month, “The FDA New Era of Smarter Food Safety Summit on E-Commerce: Ensuring the Safety of Foods Ordered Online and Delivered Directly to Consumers”, to discuss and gain insights into the world of business to consumer e-commerce involving food.

“It is now clear that this is not a trend that will be completely reversed in time but one likely to lead to a new normal in how consumers shop for food, whether it’s from restaurants, grocery stores, or companies providing meal kits and other products,” state Frank Yiannas, deputy commissioner for food policy and response at FDA and Andreas Keller, director, multi-commodity foods, Office of Food Safety at CFSAN on the FDA Voices blog. “Thus, the U.S. Food and Drug Administration is actively working with partners in federal, state, and local government and industry in the U.S. and other nations, as well as with consumer advocates, to help ensure that consumers aren’t ever unwittingly trading food safety for convenience.”

During last month’s meeting, many challenges and questions came up, from how to further prevent food tampering to labeling issues, especially related to allergens, to ensuring that food safety values are shared across all parties involved in producing, transporting and selling food in the e-commerce setting.

FDA announced that it will be reviewing and assessing the information it received during the meeting and is inviting industry to submit public comments now through November 20, 2021 (Docket FDA-2021-N-0929). From there, the agency will determine the critical issues that need to be addressed first.

The daily recordings of the virtual summit are available on FDA’s website.

Susanne Kuehne, Decernis
Food Fraud Quick Bites

It’s Official: FDA Designates New Webpage to Food Fraud

By Susanne Kuehne
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Susanne Kuehne, Decernis
FDA, Food fraud
Find records of fraud such as those discussed in this column and more in the Food Fraud Database, owned and operated by Decernis, a Food Safety Tech advertiser. Image Credit: Susanne Kuehne

Food fraud has become such an important issue that many governments are monitoring it much more closely. To keep producers and consumers informed on the latest developments, the FDA has generated a new web page on economically motivated adulteration (EMA). The page includes links on how to report food fraud (including a list of consumer complaint coordinators), important examples of adulteration (i.e., honey, olive oil and seafood), how food fraud is detected and monitored, enforcement and legal consequences such as recalls, seizures and import refusals, guidance documents to assist manufacturers and importers, and a list of import alerts.

Resource

  1. FDA. (November 4, 2021). “Economically Motivated Adulteration (Food Fraud)”.
Dole Garden Salad

Possible Listeria Contamination, Dole Recalls Garden Salads

By Food Safety Tech Staff
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Dole Garden Salad

Dole Fresh Vegetables, Inc. issued a voluntary recall of certain cases of its garden salad over concern of possible Listeria monocytogenes contamination. Although no illnesses have been reported, the company is pulling select lots of its garden salads marketed under the Dole, Marketside, Kroger and Salad Classics names.

The recall was taken as a precaution after a single sample of garden salad tested positive for Listeria monocytogenes in random sampling conducted by the Department of Agriculture in Georgia.

The company announcement states that the product is beyond its “best if used by” date and should no longer be on store shelves. The products were distributed in Alabama, Florida, Georgia, Louisiana, Massachusetts, Maryland, North Carolina, Pennsylvania, South Carolina and Virginia.

FDA

FDA Releases Results of Sampling Assignment of Romaine Lettuce from Yuma, Arizona

By Food Safety Tech Staff
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FDA

As part of its efforts to prioritize the safety of leafy greens, the FDA released the results of a sampling assignment involving testing romaine lettuce from commercial coolers in Yuma County, Arizona. Earlier this year the agency announced that it would be collecting samples of romaine lettuce as part of ongoing surveillance following the spring 2018 multistate outbreak of E.coli O157:H7.

The lettuce was tested for Shiga toxin-producing Escherichia coli (STEC), specifically enterohemorrhagic Escherichia coli (EHEC), and Salmonella spp. The FDA collected 504 romaine samples, and an independent lab conducted the testing.

E.coli O130:H11 was found in one sample, and as a result, the FDA conducted an investigation at the farm to find potential sources and routes of contamination—samples of soil, water, sediment and animal fecal material were taken, and the agency also looked at farm equipment and other surfaces. Out of 24 samples, just one came back positive for STEC, and this sample was taken from the outer leaves of the lettuce. It was determined that the strain was low risk to human health, and FDA did not find that this strain was linked to any past known foodborne illness outbreaks.

“The agency’s goal in conducting this assignment was to determine whether the target pathogens and specific strains may be present in romaine lettuce from the Yuma agricultural region, to help prevent foodborne illness when possible,” FDA stated in a constituent update. “If product that tested positive for EHEC or Salmonella was found, the Agency planned to work with industry and state regulatory partners to identify the cause (e.g., farm follow-up investigation) to inform future regulatory and/or research efforts and to develop strategies that could help preventive additional outbreaks.”

FDA

FDA Launches Office of Digital Transformation

By Food Safety Tech Staff
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FDA

Taking a step further in prioritizing technology and data modernization efforts, today the FDA announced the launch of a new Office of Digital Transformation. The office realigns the agency’s information technology, data management and cybersecurity roles into a central office that reports directly to the FDA commissioner. The reorganization will also help FDA further streamline its data and IT management processes, reducing duplication of processes, and promote best practices, technological efficiencies and shared services in a strategic and secure way.

“Good data management, built into all of our work, ultimately helps us meet and advance the FDA’s mission to ensure safe and effective products for American families,” said Acting FDA Commissioner Janet Woodcock, M.D., in an FDA news release. “The agency began these efforts because, as a science-based agency that manages massive amounts of data to generate important decisions and information for the public, innovation is at the heart of what we do. By prioritizing data and information stewardship throughout all of our operations, the American public is better assured of the safety of the nation’s food, drugs, medical devices and other products that the FDA regulates in this complex world. This reorganization strengthens our commitment to protecting and promoting public health by improving our regulatory processes with a solid data foundation built in at every level.”

 

FDA

FDA Announces 12 Winners of Traceability Challenge

By Food Safety Tech Staff
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FDA

Back in May, FDA launched a technology traceability challenge with the goal of promoting innovation in the development of scalable and affordable traceability technology tools for food operations of all sizes. Today, the agency announced the winning teams and their technologies:

  • FarmTabs. Free, downloadable software run on Microsoft Excel to aid small and mid-size farmers manage records for traceability/ farm-related metrics.
  • Freshly. Traceability and batch-tracking software for small businesses (including retailers, manufacturers and distributors).
  • HeavyConnect. Cloud-based digital traceability and compliance documentation solutions, including a mobile app for producers to capture data in the field and share it across the supply chain.
  • ItemChain. Item-level traceability to each party in the supply chain.
  • Kezzler. Solution uses self-service portals to generate item-level identifiers and associate homogenized datasets at the grower level through mobile applications.
  • Mojix. Uses industry standards to link traceability events for each item or lot throughout the supply chain in an open data network.
  • OpsSmart. Cloud-based traceability software solution for food safety, recall management, and traceability in a complex supply chain.
  • Precise’s. Traceability Suite that provides end-to-end supply chain tracking to all segments of the food market, using geospatial, machine learning and IoT technologies.
  • Roambee/GSM/Wiliot’s. Solution uses low-cost IoT sensor tags in with shipment visibility and verification technologies for end-to-end traceability.
  • Rfider. Software-as-a-service that captures, secures and shares critical event data along supply chains to consumers.
  • TagOne. A role-based data capture framework that updates an open source blockchain platform, and uses industry standards to ensure interoperability, and ease of use and data security.
  • Wholechain. Supply chain traceability system that uses blockchain technology to trace products back to the original source.

The videos submitted by each winning company are available on FDA’s webpage that announces the winners.