Tag: FDA

  • California Citrus Mutual Welcomes FDA Update to Orange Juice Standard

    California Citrus Mutual (CCM) recently welcomed the U.S. Food and Drug Administration’s decision to update the federal standard of identity for pasteurized orange juice. The action marks the first significant revision to the standard in more than 60 years and takes effect Aug.19.

    Under the revised standard, orange juice will be permitted to contain up to 15% juice from mandarins and mandarin hybrids while still being labeled orange juice. The rule also adjusts the minimum sugar-content threshold, known as the Brix level, to reflect current growing conditions. Together, the changes bring the decades-old standard in line with today’s citrus industry and strengthen the domestic juice supply.

    The FDA reviewed consumer sensory data during its rulemaking process and concluded that the change will not alter how consumers perceive orange juice. The agency found the update preserves the taste and quality consumers expect while giving domestic producers greater flexibility and reducing reliance on imported juice.

    CCM supported the update through the FDA’s public rulemaking process, submitting comments in favor of the change and working with members of Congress to advance it. The petitions that prompted the rule were led by Florida’s citrus industry, whose growers have faced production challenges from disease and severe weather.

    “The California citrus industry thanks the FDA for updating the orange juice standard and allowing the blending of complementary citrus varieties,” said Jacob Villagomez, CCM Director of Governmental Affairs. “This decision supports domestic juice production, reduces reliance on imports, and ensures consumers continue receiving the quality and flavor they expect.”

    The change is expected to create new opportunities for California growers, who produce large volumes of mandarins and mandarin hybrids. California is predominantly a fresh-market supplier, and the higher blending allowance opens a stronger processing outlet for fruit that does not reach the fresh market. Mandarins have become an increasingly important part of California’s citrus production.

    CCM appreciates the FDA’s willingness to update a decades-old regulation through a science-based process that benefits growers, processors, and consumers alike. — Story contributed by California Citrus Mutual

  • Cyclospora Outbreak Linked to Iceberg Lettuce

    The FDA and CDC, in collaboration with state and local partners, are investigating a multistate outbreak of Cyclospora illnesses linked to shredded iceberg lettuce served at Taco Bell locations in Indiana, Kentucky, Michigan, Ohio and West Virginia. The illnesses included in this outbreak are a subset of the Cyclospora illnesses identified nationwide.

    Based on epidemiological information collected by CDC, a total of 1,644 people infected with Cyclospora and reporting exposure to Taco Bell have been reported by five states. Illnesses started on dates ranging from May 13 to July 13. There have been 94 hospitalizations and no deaths have been reported. Michigan analyzed food exposure details from 190 of the cases who reported eating at Taco Bell and shared these findings with CDC. Ingredient level analyses on meals eaten by these cases indicate that 90% of those interviewed reported eating iceberg lettuce.

    FDA’s traceback investigation has identified convergence on a single supplier of iceberg lettuce from Mexico used by Taco Bell locations where sick people ate before becoming ill.

    FDA is working directly with the identified supplier to determine if potentially contaminated shredded iceberg lettuce remains on the market. As part of this investigation, FDA and state partners have initiated collection of product samples for testing and analysis. Additionally, FDA has increased screening at the border for products implicated in the outbreak.

    FDA is also working with Taco Bell and they have committed to stop using any lettuce from the supplier identified by FDA’s traceback investigation.

    FDA and state partners are actively investigating the source and scope of the contamination. Because the investigation remains ongoing, additional implicated brands, restaurants, retailers or distribution channels may be identified as the investigation continues. This advisory will be updated promptly as new information becomes available.

    FDA is aware that the case counts in this advisory may not match what is being reported by individual states. State data may include both probable and confirmed cases, while CDC and FDA include confirmed cases only. State case counts may also include initial case reports that have not yet been reported to CDC. As cases are confirmed, these numbers will continue to update.

    Additionally, 2026 national surveillance numbers reported by the CDC track laboratory-confirmed cases in the U.S. overall, which include this outbreak as well as illnesses that are not a part of this outbreak. — Story contributed by the U.S. Food and Drug Administration

  • Outbreak Investigation of Salmonella in California Onions

    The U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC), in collaboration with state and local partners, are investigating an outbreak of Salmonella Thompson infections linked to fresh diced onions from Gills Onions of Oxnard, California.

    Based on epidemiological data collected by CDC, 14 of 19 cases with information available reported exposure to fresh diced onions before becoming ill. Additionally, based on traceback data collected by FDA, FDA determined that onions processed at Gills Onions were available at points of service where people ate prior to becoming ill.

    In response to this investigation, Gills Onions has voluntarily recalled diced yellow onion, diced onions & celery, diced mirepoix, and diced red onions.

    The investigation is ongoing to determine the source of contamination and whether additional products are linked to illnesses. FDA will update this advisory should additional consumer safety information become available.

    Read the full update

  • FDA Will Not Conduct Broad Sampling of Salinas Valley Leafy Greens in 2022

    The U.S. Food and Drug Administration will not conduct broad sampling of leafy greens grown in the Salinas Valley region of California for the 2022 growing season.

    The decision was made based on data from Western Growers, the California Leafy Greens Marketing Agreement, and the California Department of Food and Agriculture inspection activities.

    The FDA encouraged the organizations to continue to work with the agency to enhance the sharing of industry information on pre-harvest and post-harvest testing as all parties aim to assure the safety of leafy greens.

    “Western Growers is committed to developing and deploying data collection and analytic digital tools to further enhance the sharing of industry information,” said De Ann Davis, WG’s Senior Vice President of Science. “We think this is an encouraging development for our members as we strive to grow the safest produce possible.”

    The FDA notes they are considering risk-based surveillance sampling based on historical data and information from previous outbreaks of foodborne illness and reserves the right to reassess this approach if unforeseen events occur.

  • FDA Issues Report Highlighting Salmonella Outbreak in Packaged Leafy Greens

    The U.S. Food and Drug Administration (FDA) has released a report on its investigation of the Salmonella Typhimurium outbreak that caused 31 reported illnesses and four hospitalizations in the U.S. between June and August 2021. The FDA worked with the U.S. Centers for Disease Control and Prevention (CDC) and state partners to investigate the outbreak, which was linked through epidemiology and traceback to packaged salad greens during the summer of 2021. This outbreak is believed to be FDA’s first domestic investigation of a foodborne illness outbreak associated with leafy greens grown in a Controlled Environment Agriculture (CEA) operation. The CEA operation produces leafy greens using common commercial high density hydroponic growing techniques with deep water culture and floating raft production methods. The report released today includes an overview of the traceback investigation, investigation results, and various factors that potentially contributed to the contamination of packaged leafy greens with Salmonella.

    Although a conclusive root cause was not identified, the agency identified certain conditions and practices that could result in contamination, including the presence of a different serotype of Salmonella in pond water used to grow the leafy greens, growth media storage practices, water management practices, and general sanitation practices at the CEA that were inadequate to prevent the introduction or spread of microorganisms of public health significance into the leafy greens.

    FDA isolated the outbreak strain of Salmonella Typhimurium in a stormwater retention basin adjacent to the CEA farm. However, the investigation did not reveal if that stormwater retention basin was the source of the Salmonella that ultimately contaminated the leafy greens. This highlights the importance of assessing all microbial hazards, including those associated with adjacent and nearby land uses.

    In light of this report, FDA highlights the following requirements and recommendations applicable to firms, such as the hydroponic operation implicated in this S. Typhimurium outbreak, engaged in CEA. Here are some of the requirements and recommendations:

    • Develop a keen understanding of potential sources and routes of contamination including the raw materials and inputs used, as well as possible sources of contamination throughout the operation.
    • Implement effective sanitation procedures and sampling plans while also paying close attention to hygienic operations and equipment design, ensuring cleaning procedures do not contribute to the dispersion of microbial contaminants that may be present.
    • Assess growing operations to ensure implementation of appropriate science- and risk-based preventive measures, including applicable required provisions of the FDA Food Safety Modernization Act (FSMA) Produce Safety Rule and good agricultural practices (GAPs).
    • Implement procedures that are effective in rapidly cooling and cold holding harvested leafy greens after harvest and verify the effectiveness of the cooling and cold holding procedures, including the routine monitoring of processing and storage environments and product temperatures to prevent pathogen growth in harvested leafy greens.
    • If employing tools such as pre-harvest and post-harvest sampling and testing of food, water, and the physical environment, seek to identify and inform sampling plans, limits of detection, and mitigation measures that control potential sources and routes of bacterial contamination in the growing and harvesting environment.
    • Ensure that all growing pond water is safe and of adequate sanitary quality for its intended use, which includes implementing measures (such as water treatment) necessary to reduce the potential for contamination by known or reasonably foreseeable hazards.
    • Perform a root cause analysis when a pathogen is identified in the growing environment, in raw agricultural inputs such as water, or in the agricultural commodity to determine how the contamination likely occurred and implement appropriate prevention and verification measures.
    • Assess and mitigate risks associated with adjacent and nearby land uses that may impact CEA operations, in both rural and more urbanized settings.

    These requirements and recommendations are just some examples that serve as a reminder that as the use of CEA is increasing globally, all types of food production must continue to address basic food safety concerns, including potential sources and routes of contamination. Food safety is a shared responsibility that involves food producers, distributors, manufacturers, retailers, and regulators. Recognizing the interconnection between people, animals, plants, and their shared environment when it comes to public health outcomes, we encourage collaboration among various groups in the broader agricultural community (i.e., produce growers, state government and academia) to address this issue. The FDA is committed to working with these stakeholders to advance critical work.

    For More Information:

  • FDA Findings from Yuma Romaine Lettuce Sampling

    The FDA is releasing the findings of a sampling assignment for which FDA collected and tested romaine lettuce from commercial coolers in Yuma County, Arizona during February and March 2021. The agency tested the lettuce for Shiga toxin-producing Escherichia coli (STEC), specifically enterohemorrhagic Escherichia coli (EHEC), and Salmonella spp. This assignment was part of the FDA’s ongoing surveillance following multistate E. coli O157:H7 outbreaks of foodborne illness in recent years linked to or potentially linked to romaine lettuce.

    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. 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.

    The FDA collected 504 romaine samples for EHECs and Salmonella spp., with the testing performed by an independent laboratory on contract, as part of a pilot project. Each sample consisted of 10 subsamples, and each subsample was made up of at least 300 grams of romaine lettuce (whole heads, hearts or individual leaves).  Collecting and testing samples composed of multiple subsamples increases the probability of detecting pathogens if present, since microbial hazards may not be uniformly present.

    During the assignment the FDA detected E. coli O130:H11 in one sample.  The isolate was found to be moderate to high risk and could be capable of causing severe illness in humans, though it was not linked to any known human illnesses, and no product ever reached consumers. The owner of the product did not harvest the remaining crop from the field where it was grown.

    In response to the finding, FDA conducted an investigation at the farm to identify possible sources and routes of contamination. The FDA was able to collect romaine lettuce from the field, multiple samples of soil, water, sediment, and animal fecal material. FDA also assessed farm equipment and other surfaces. Only one of the total 24 samples yielded STEC (specifically, E. coli O116:H-). This sample came from the outer leaves of romaine lettuce. The strain was further characterized as low risk to human health, and FDA’s analysis indicated the strain was not linked with any past known foodborne illness outbreaks.

    Helping to ensure the microbiological safety of leafy greens continues to be a priority of the FDA. Romaine lettuce and other leafy greens are among the most widely consumed vegetables in the United States and are an important part of a healthy diet. The agency is working on several fronts to help prevent microbial contamination of leafy greens and to prevent outbreaks of foodborne illness. Chief among these efforts is the FDA’s Leafy Greens STEC Action Plan (LGAP), which features public health approaches related to response, prevention and addressing knowledge gaps. The FDA continues to collaborate with industry, states, academia and other stakeholders through activities outlined in the LGAP to address this important public health issue.

  • FDA Releases Findings Following 2020 Outbreak Linked to Central Valley Peaches

    The U.S. Food and Drug Administration (FDA) has released a report on its investigation of the Salmonella Enteritidis outbreak in Peaches. The FDA and multiple state and federal partners investigated an outbreak of Salmonella Enteritidis infections that were linked to the consumption of peaches during the summer of 2020. In total, the outbreak caused 101 reported illnesses across 17 states, including 28 hospitalizations. This appears to be the first time a Salmonella outbreak has been linked to peaches.

    The FDA conducted this investigation in conjunction with the U.S. Centers for Disease Control and Prevention (CDC), state partners, and Canadian public health officials between August and October 2020. The epidemiological and traceback investigation determined that peaches packed or supplied by a large grower/producer were the likely source of the outbreak. The traceback evidence informed and helped to prioritize two subsequent investigations of peach packing/holding operations and peach orchards in Cutler, Kerman, and Sanger, California.  The large grower/producer cooperated with FDA throughout the investigation and is continuing to engage with FDA on the agency’s findings and recommendations.

    Investigators conducted over 700 tests on environmental, peach, and peach tree leaf samples.  While no test results matched the 2020 outbreak strain, four tests conducted on peach and peach tree leaf samples collected from an orchard adjacent to a poultry operation yielded positives for Salmonella Alachua which were further linked via whole genome sequencing (WGS) to 2019 and 2020 chicken isolates. This finding prompted a follow-up investigation more closely focused on growing areas and a voluntary recall by the firm, preventing the tested, contaminated product from reaching the market. During the follow-up investigation, two tests of peach tree leaf samples collected from orchards adjacent to a cattle feedlot yielded positives for Salmonella Montevideo that were genetically similar via WGS to 2018-2020 beef and cattle isolates.

    While investigators did not find the outbreak strain, and the strains of Salmonella found during this outbreak were not linked to any clinical illnesses, the investigational findings reinforce the FDA’s concern about the potential impact that adjacent land uses can have on the safety of produce.

    The FDA views the implementation of appropriate science- and risk-based measures to reduce the potential for contamination of peaches and other produce as the most effective and practicable means to improve the safety of fresh produce, especially when measures are tailored to the specific practices and conditions on individual farms. The FDA encourages all growers to be cognizant of and assess risks that may be posed by adjacent and nearby land uses, including for the potential impact of dust exposure. The FDA also recognizes the interconnection between people, animals, plants, and their shared environment when it comes to public health outcomes, and we encourage collaboration among various groups in the broader agricultural community (e.g., produce growers, those managing animal operations, state and federal government agencies, and academia) to address this issue.

    For additional information

  • FDA Issues Report Highlighting Salmonella Outbreak in Red Onions

    The U.S. Food and Drug Administration (FDA) has released a report on its investigation of the Salmonella Newport outbreak that caused more than 1,600 reported illnesses in the U.S. and Canada between June and October 2020. The FDA worked with the U.S. Centers for Disease Control and Prevention (CDC), state partners, and Canadian officials (Public Health Agency of Canada and Canadian Food Inspection Agency) to investigate the outbreak, which was linked through epidemiology and traceback to whole red onions supplied by Thomson International Inc., headquartered in Bakersfield (Southern San Joaquin Valley) with additional operations in Holtville (Imperial Valley), California. The outbreak is the largest Salmonella foodborne illness outbreak in over a decade. The report released today includes an overview of the traceback investigation, subsequent on-site interviews, visual observations of the growing fields, and environmental sampling, and various factors that potentially contributed to the contamination of red onions with Salmonella.

    Although a conclusive root cause could not be identified, several potential contributing factors to the 2020 Salmonella outbreak linked to red onions were identified. These include:

    • potentially contaminated sources of irrigation water;
    • sheep grazing on adjacent land;
    • signs of animal intrusion, including scat (fecal droppings), and large flocks of birds that may spread contamination; and
    • food contact surfaces that had not been inspected, maintained, or cleaned as frequently as necessary to protect against the contamination of produce.

    In sampling conducted in Holtville, CA, the FDA found Salmonella Newport in 10 water (irrigation, seepage, and drainage) and one sediment subsamples. However, the whole genome sequencing of these samples did not match the outbreak strain.

    Although a conclusive root cause could not be identified, several potential contributing factors to the 2020 red onion outbreak were identified, including a leading hypothesis that contaminated irrigation water used in a growing field in Holtville, CA may have led to contamination of the onions.

    In light of this report, the FDA encourages all farms to:

    • assess growing operations to ensure implementation of appropriate science and risk-based preventive measures, including applicable provisions of the FDA Food Safety Modernization Act (FSMA) Produce Safety Rule and good agricultural practices;
    • implement industry-led root-cause analyses to determine how the contamination likely occurred when pathogens are identified through pre-harvest or post-harvest testing of produce, or microbiological surveys;
    • be aware of and consider the risks that may be posed by adjacent and nearby land uses, especially as it relates to the presence of livestock and the interface between farmland, rangeland, irrigation water, and other agricultural areas;
    • consider additional tools such as pre-harvest and/or post-harvest sampling and testing of products to help inform the risk assessment and clarify the need for specific prevention measures; and
    • improve traceability by increasing digitization, interoperability and standardization of traceability records; and
    • follow good agricultural practices to maintain and protect the quality of water sources.

    Thomson International Inc. cooperated with the FDA throughout the investigation and is continuing to engage with the FDA on the agency’s findings and recommendations.

    Food safety is a shared responsibility that involves food producers, distributors, manufacturers, retailers, and regulators. Recognizing the interconnection between people, animals, plants, and their shared environment when it comes to public health outcomes, we encourage collaboration among various groups in the broader agricultural community (i.e. livestock owners and produce growers, state government and academia) to address this issue. The FDA is committed to working with these stakeholders to advance critical work.

    For More Information:

  • FDA to Implement Sampling Effort for Lettuce Grown in Salinas

    The U.S. Food and Drug Administration will be collecting and testing samples of lettuce grown in California’s Salinas Valley from local commercial coolers from May through November 2021. The agency will test the samples for Shiga toxin-producing Escherichia coli (STEC), including E. coli O157:H7, and Salmonella spp. as part of ongoing surveillance efforts following reoccurring outbreaks linked to this region, including most recently in the fall of 2020.

    The FDA assignment will direct sampling to be conducted at commercial cooling and cold storage facilities where field heat is removed from harvested lettuce and where product is cold-stored before processing. Sampling may include pre-cooled product (preferred) or post-cooled product. Sample collection at commercial coolers helps the FDA efficiently obtain samples from multiple farms at centralized locations and facilitates prompt traceback and follow-up if contamination is detected.

    The agency plans to collect and test a total of approximately 500 post-harvest samples of iceberg, leaf and romaine lettuce. Each sample will consist of 10 subsamples, each made up of one head of lettuce (trimmed, cored and possibly wrapped), or in the case of romaine lettuce, loose leaves or one package of hearts.  FDA laboratories will conduct all testing.

    During this sampling assignment, the FDA will take extra precautions to help ensure the safety of agency investigators and firm employees during the COVID-19 pandemic. FDA investigators will preannounce their visits to firms per the Agency’s COVID-19 safety practices. They will be outfitted with personal protective equipment (PPE) and will carry out their work while adhering to local, state and applicable CDC guidance.

    Helping to ensure the safety of leafy greens remains a high priority of the FDA. This assignment adds to other work underway in collaboration with stakeholders in the California Central Coast growing region to identify where the recurring strain of pathogenic E. coli is persisting and the likely routes of leafy green contamination with STECs.  This includes continued implementation of actions identified in the recently updated Leafy Greens Action Plan, including a multi-year longitudinal  study to assess the environmental factors impacting the presence of foodborne pathogens in this region. Consistent with the action plan, if the FDA detects a pathogen such as E. coli O157:H7, the agency will conduct a follow-up investigation to identify potential sources and routes of contamination. Such investigations are designed to inform what additional preventive measures may be needed to help prevent outbreaks of foodborne illness.

  • FDA, CDFA, Western Center for Food Safety, and CA Ag Stakeholders Partner to Enhance Food Safety

    California leads the world in leafy greens production and innovation. Industry and food safety officials are proud to partner on this in-depth scientific study protecting public health.” — CDFA Secretary Karen Ross

    The U.S. Food and Drug Administration is announcing the launch of a multi-year study to improve food safety through enhanced understanding of the ecology of human pathogens in the environment that may cause foodborne illness outbreaks. This initiative is being launched with partners including the California Department of Food and Agriculture (CDFA), the University of California, Davis, Western Center for Food Safety (WCFS), and agricultural stakeholders in the Central Coast of California.

    The launch of this study follows a series of E. coli O157:H7 outbreaks in recent years linked to California’s lettuce production regions, particularly the most recent three outbreaks in the fall of 2019 which collectively resulted in 188 people falling ill. In response, FDA launched an investigation, the findings of which are outlined in a report released in May 2020. The FDA also published a Leafy Green STEC Action Plan to address issues associated with leafy green Shiga toxin-producing E.coli (STEC) contamination. This new longitudinal study is included in the action plan, as well as the continuation of a similar study being conducting in the Yuma, Arizona, growing region.

    A key component of the Leafy Green STEC Action Plan is the need to address knowledge gaps in order to advance prevention. The multi-year study will examine how pathogens survive and move through the environment and possibly contaminate produce through work with water quality, food safety, and agricultural experts from the Western Center for Food Safety, representatives from various agriculture industries, and members of the leafy greens industry.

    Research teams will be collecting and examining samples from the environment including adjacent land, well and surface waters, soil inputs that include compost, dust and animal fecal samples.

    The California Central Coast region grows a significant portion of the nation’s leafy greens. The findings from this study will contribute new knowledge on how various environmental factors may influence bacterial persistence and distribution in this region, and how those factors may impact the risk of leafy greens becoming contaminated. Results from this collaboration will lead to improved practices to prevent or mitigate food safety risks, and ultimately enhance the safety of leafy greens grown in California.