According tho the Wall Street Journal, President Trump has signed off on a plan to fire Food and Drug Administration Commissioner Marty Makary.
Top administration officials have become increasingly convinced Makary has to go because, in addition to months of turmoil, complaints from some in the pharmaceutical industry have continued to mount, people familiar with the matter said. Kennedy last year had considered installing someone else to run the FDA while Makary remained a figurehead.
The Wall Street Journal reported that Trump recently became frustrated with Makary for not moving fast enough to approve flavored vapes and other nicotine products. Makary in February refused to authorize blueberry and mango vape flavors from Los Angeles manufacturer Glas, worried that fruit flavors would encourage youth vaping. After the pressure from Trump, he reversed course and authorized the flavors. Makary has also run into criticism from biotech companies with rare-disease drugs, as well as patients and their advocates.
Marjorie Dannenfelser, the influential president of antiabortion group Susan B. Anthony Pro-Life America, recently renewed her call for Makary to be fired. The Wall Street Journal reported that Makary said he could have stalled approval of a generic form of the abortion pill, but didn’t.
Trump tapped Makary for the FDA post in November 2024, as Kennedy and other health department leaders bonded in meetings at Dr. Mehmet Oz’s oceanfront Florida mansion. Kennedy described Makary, along with Oz and National Institutes of Health Director Jay Bhattacharya, as “friends” who stayed in each other’s homes and vacationed together, in a Fox News interview last year.
Update March 30, 2026: Since the last FDA announcement on March 15, 2026, two (2) additional illnesses have been reported. A total of nine (9) people infected with the outbreak strain of E. coli have been reported from three (3) states. Illnesses started on dates ranging from September 1, 2025, to February 20, 2026. Three (3) people have been hospitalized and one (1) person developed hemolytic uremic syndrome (HUS), a serious condition that can cause kidney failure. No deaths have been reported. Over half of the illnesses are in children under five (5) years old.
State and local public health officials are interviewing people or their caregivers about the foods they ate in the week before they got sick. Of the eight (8) people interviewed, all eight (8) (100%) in this outbreak reported consuming or being served raw dairy products.
Of the eight (8) people interviewed, seven (7) had brand information available. One (1) person drank raw milk but didn’t know the brand. Of the seven (7) people interviewed who knew a brand, seven (7) (100%) reported RAW FARM-brand dairy products. In 2026, five (5) people reported consuming or being served RAW FARM-brand raw cheddar cheese. In 2025, two (2) sick people reported consuming RAW FARM-brand raw milk. Affected RAW FARM-brand raw milk from 2025 should no longer be for sale.
Whole genome sequencing (WGS) analysis of E. coli isolates from ill people shows that they are all closely related genetically to each other. This means that people in this outbreak are likely to share a common source of infection.
FDA has initiated an onsite inspection at RAW FARM, LLC in coordination with state partners. To date, FDA is not aware of any positive E. coli tests in RAW FARM-brand raw cheddar cheese products from this time period. FDA will update this advisory should additional information become available.
Original News Story March 19, 2026: The FDA and CDC, in collaboration with state and local partners, are investigating a multistate outbreak of E. coli O157:H7 infections as reported on FDA’s website
As of March 14, 2026, a total of 7 confirmed infections have been reported from three states, including CA (5), FL (1), and TX (1). Known illness onset dates range from September 1, 2025 to February 13, 2026. Whole genome sequencing analysis of E. coli isolates from ill people shows that they are all closely related genetically to each other. This means that people in this outbreak are likely to share a common source of infection. Additionally, 4 of 7 cases are 3 years old or younger. Two patients have been hospitalized. No deaths or HUS cases have been reported.
State and local public health officials have interviewed 3 ill people about food exposures of interest in this outbreak. All 3 people (100%) reported eating RAW FARM- brand raw cheddar cheese. State and local officials are working to gather additional data for the 4 other illnesses, including 2 illnesses that occurred in 2025. Epidemiologic evidence indicates that RAW FARM-brand raw cheddar cheese products made by RAW FARM, LLC are the likely source of this outbreak.
FDA has recommended that RAW FARM, LLC voluntarily remove their raw cheese products from the market, and the firm has declined.
On the company’s website, RAW FARM issued their official statement “We 100% disagree with FDA’s false possible link and extreme allegations.” Aaron McAFee, President of RAW FARM is filmed in a 2:13 minute YouTube video explaining their position.
FDA states, the investigation is ongoing to determine the source of contamination and whether additional products are linked to illnesses. To date, to FDA’s awareness, no RAW FARM-brand cheddar cheese products from this time period have tested positive for E. coli. As part of this investigation, state partners initiated collection of product samples for testing and analysis, but results are not yet available.
On March 17, 2026, the U.S. Food and Drug Administration’s (FDA) Office of Coordinated Outbreak Response, Evaluation, & Emergency Preparedness (CORE+EP) released its annual report summarizing the investigations of foodborne illness outbreaks and certain adverse events in FDA-regulated human foods for the 2024 calendar year.
The FDA’s CORE+EP, originally established in 2011 as the CORE Network, expanded in October 2024 to include an emergency preparedness team focused on food defense, traceability, and supply chain management. One of CORE+EP’s missions is to find, stop, and aid in the prevention of foodborne illness outbreaks. This is accomplished through disease surveillance, outbreak response, post-response activities, and collaboration with the U.S. Centers for Disease Control and Prevention (CDC), state and local public health agencies, and international public health partners. Every year, CORE teams evaluate and respond to numerous foodborne outbreaks and certain adverse events linked to FDA-regulated products.
In 2024, CORE teams evaluated 72 incidents, responded to 26, and issued advisories for 10. These numbers remain similar to those from recent years, with 69 incidents evaluated, 25 responses, and 10 advisories issued in 2023. In 2024, CORE investigations resulted in numerous public health actions, including recalls, public health advisories, a Warning Letter, a consent decree of permanent injunction, and FDA prevention strategies.
The 2024 annual report highlights a few noteworthy outbreaks: a large outbreak of E. coli linked to carrots, a historical outbreak of illnesses associated with cheese, and a novel series of adverse events linked to certain chocolate bars, cones, and gummies.
By Allen R. Sayler, Benjamin J. Reading, Ph.D., Jason Bashura, MPH, R.S., Mehrdad Tajkarimi, DVM, MPVM, Ph.D. No Comments
The United States (U.S.) food protection system is fragmented across federal, state, and local jurisdictions, resulting in duplication, inefficiency, and systemic failures that undermine public health and erode consumer trust. Foodborne pathogens such as Listeria, Salmonella, and E. coli do not respect institutional boundaries, yet responsibility for oversight is divided among more than 15 federal agencies, 75 state entities, and thousands of local jurisdictions, operating under more than 30 laws and 70 interagency agreements. This structure has proven incapable of reducing the persistent burden of foodborne illness in the U.S. The Centers for Disease Control and Prevention (CDC) estimate one in six Americans is affected annually, causing 10 million illnesses, 53,000 hospitalizations, and more than 900 deaths.
The term food protection, in use since at least 1924, conceptually unifies food safety, defense, authenticity, and infrastructure protection. However, the lack of an integrated federal entity has perpetuated disjointed responses. The 2025 recall of chicken fettuccine alfredo meals—linked to 17 illnesses, 16 hospitalizations, three deaths, and one fetal loss (as of this date)—illustrates the shortcomings of the system. Oversight was split between the Department of Health and Human Services (DHHS) Food and Drug Administration (FDA), which regulated the non-meat components, and the U.S. Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS), which oversaw the chicken ingredient. Despite involvement from CDC, the outbreak was not contained in time to prevent fatalities. Similarly, the 2024 deli meat Listeria outbreak, responsible for 10 deaths and 61 illnesses, highlighted the failure of FSIS to enforce corrective actions despite documented ongoing sanitation-based violations. These preventable events underscore the limitations of the current model.
The Government Accountability Office (GAO) has repeatedly called for consolidation—in 2005 and again 20 years later in 2025—emphasizing that inefficiencies, regulatory conflicts, and siloed data hindering effective food protection, resulting in preventable public health impacts. Reports also document how FSIS’s 6,500-employee continuous inspection program expends enormous resources without measurably improving outcomes. Decentralized data management further impedes trend analysis, predictive modeling, and risk-based decision-making that could anticipate and prevent outbreaks.
A unified federal food protection entity would provide structural and scientific coherence, resulting in the desired outcomes described herein. By consolidating regulatory authority, streamlining enforcement, and centralizing data, such an entity could accelerate response times, enhance accountability, and foster consistent risk-based regulation. Integrating modern technologies such as artificial intelligence and predictive analytics would strengthen surveillance, while harmonized training and inspections would maximize public health protections and reduce duplication and industry burden. Examples from Canada and the United Kingdom—both of which have lower per-capita illness rates—demonstrate the effectiveness of nationally unified food protection systems.
Congressional recognition of these systemic weaknesses has spurred legislative proposals in 2025 to establish a single food protection authority. This initiative reflects both scientific necessity and policy urgency. A consolidated approach would align regulatory practice with the realities of microbial ecology, supply chain complexity, and consumer demand for safe and wholesome foods.
In conclusion, the U.S. food protection system requires modernization and unification. Reform should focus on five core directives:
Improving public health through risk-based regulation
Eliminating overlap and duplication
Streamlining enforcement and compliance
Increasing accountability and modernizing governance
Strengthening food protection as a component of national security
A unified federal food protection entity would provide a vision forward with four prime outcomes:
Protect public health more effectively
Reduce regulatory and economic burden
Improve resilience against both natural and intentional threats
Deliver a modern, science-based food protection system for the 21st century and beyond
“One system, one standard, one mission: Protecting America’s food supply from farm to fork.”
—Guiding principle for U.S. food safety efforts, FSIS
Click on the image to download the complete 45 page Whitepaper:
ICYMI: Click on the image to watch this recorded webinar with two of the Whitepaper Authors, Jason Bashura and Ben Reading:
Ben and Jason discuss the need for truly unified, risk-based U.S. food protection system in this 26 minute recorded webinar
The FDA is releasing a risk assessment that was conducted to evaluate and quantify the risk of human illness associated with consumption of produce grown in fields or other growing areas with untreated biological soil amendments of animal origin (BSAAO), including raw manure. Results of the risk assessment will be used to inform policy decisions regarding appropriate standards for the use of raw manure and other untreated BSAAO when growing produce.
Pathogens on produce, such as Shiga toxin-producing Escherichia coli (STEC) O157:H7, Salmonella, and STEC non-O157 can cause human illness. The survival rate of pathogens from untreated BSAAO and their risk of contaminating crops are determined by various factors, including environmental conditions and agricultural practices. The FDA’s risk assessment investigated these factors and provides critical insights essential for protecting the nation’s produce supply and helping to ensure safe food for all Americans.
The untreated BSAAO risk assessment was completed in two phases. Part 1 focused on pre-harvest practices and conditions to determine the likelihood of produce being contaminated with pathogens before it is picked. It specifically analyzes how interventions, such as the waiting period between applying untreated BSAAO and harvesting the crops, affect the potential concentration of pathogens on the produce at the time of harvest. Part 2 modelled the path of potentially contaminated produce from the farm through the supply chain to the consumer. It includes processing activities, potential for cross-contamination during processing, transportation and storage, produce consumption, and the amount of pathogen exposure (STEC O157:H7, Salmonella, and STEC non-O157) required to cause illness through consumption of the produce commodity.
The main conclusion of this risk assessment is that extending the time between the application of untreated BSAAO and produce harvest significantly reduces the potential level of human pathogens on produce at the time of harvest. The effectiveness of this waiting period varied among the human pathogens analyzed and type of untreated BSAAO, as influenced by regional environmental conditions and the initial level of human pathogens in the raw manure.
The risk assessment model may also serve as a tool for stakeholders and industry in evaluating risks that may be associated with their agricultural practices and environmental conditions.
The U.S. Food and Drug Administration reported that it is sharing initial findings from a multi-year environmental study conducted in California’s Central Coast agricultural region that will inform efforts to further improve the safety of produce — an essential component of a healthy diet. The California Longitudinal Study was conducted in partnership with the Western Center for Food Safety at the University of California, Davis, the California Department of Food and Agriculture, and regional agricultural stakeholders.
The Central Coast of California is farmed year-round and supplies a large volume of produce, which includes more than 400 commodities. However, there have been periodic foodborne illness outbreaks associated with the region, including several that occurred between 2016 and 2020 caused by the same E. coli O157:H7 strain. This study sought to identify environmental factors that significantly contribute to the introduction, persistence, and spread of foodborne pathogens that could contaminate produce prior to harvest. Increasing FDA’s understanding of the ecology of this growing region as it pertains to foodborne pathogens is to the benefit of consumers, producers, academia, and food safety officials as it allows for continued improvement in best growing practices to enhance food safety.
The longitudinal study, which began in 2020, followed an adaptive research design in which sample collection matrices, sites, and frequencies were continually assessed and refined to obtain maximum useful, practical information. Through repeated sample collection, testing, measurement, and analysis, the research team observed trends in pathogen presence in this region over time, providing insightful information on prevalence, location, and potentially influencing factors such as seasonality, weather conditions, and domesticated and wild animal activities on adjacent and nearby land.
Initial findings related to E. coli O157:H7 and other Shiga toxin-producing Escherichia coli (STEC) have been posted to the FDA’s California Longitudinal Study webpage and are summarized below:
Animal Sources of Contamination: Fecal samples from rangeland beef cattle, feral pigs, deer, birds, and coyotes were frequent sources of STEC. Viable STEC was recovered from fresh and older, drier feces from livestock and wildlife found in the sampling area. These results suggest that STEC may remain viable in fecal material for extended periods.
Environmental Sources of Contamination: Surface waters and associated sediments may facilitate STEC persistence, and in the case of water, STEC movement in the region. STEC was not recovered in a substantial amount of soil or air samples, indicating that these are not likely impacting the spread of STEC in the region. However, STEC was observed in water and sediment from rivers and creeks, and to a lesser extent in irrigation tailwater and tailwater sediment (accumulations of field runoff from irrigation practices) collected at field edges.
STEC Diversity, Persistence, and Movement: Twelve different E. coli O157:H7 strains were isolated from environmental samples; however, the strain responsible for outbreaks between 2016 and 2020 was not recovered. STEC isolated from wildlife feces genetically matched strains from cattle feces, other wildlife feces, and in some cases, water, sediment, and soil. Six different highly pathogenic STEC serotypes were identified and some strains of these serotypes persisted for nearly two years.
The FDA will engage with stakeholders to further discuss the data and findings from this study and assist stakeholder efforts to develop practices to manage the risks posed by the potential sources of contamination. Additional information and publications will be added to FDA’s California Longitudinal Study webpage as they become available.
Dr. Mindy Brashears, Under Secretary for Food Safety, USDA and Dr. Donald A. Prater, Principal Deputy Director for Human Foods, FDA will present at the Food Safety Hazards Conference, April 20-22 in St. Louis MO. The format is a fireside chat with a town hall Q&A, moderated by Brian Ronholm, Director of Food Policy, Consumer Reports.
The Food Safety Hazards Conference will take place April 20-22 in St. Louis MO. The Program starts on Monday April 20 at 12 pm which leads into two full days of high-level panel discussions and educational presentations concluding Wednesday, April 22 at 12 noon CST. Presentations include:
* Regulators in the Spotlight: FDA & USDA’s Vision for Safer Food
* Practical Pathogen Control Strategies for Complex Food Operations: Lessons from Real-World Implementation
* Food Allergen Safety – On the Other Side of the Threshold
* Assessing Heavy Metal Risks in Food Systems: A Preventive Food Safety Approach to Protect Public Health
* Forecasting Microbial Behavior: Predictive Tools for Smarter Hazard Analysis
* Transforming Pest Control Through FMEA: A Predictive, Risk-Based Framework for Preventing Food Safety Hazards
* Cybersecurity and Food Safety: HACCP Meets Hacking
* End to End Foreign Material Control: A Practical Guide for Manufactures
* Less Chemicals, More Microbes? The Use of Clean-Label Ingredients to Formulate Processed Meats
* Sanitary Transportation – Bulk Tankers – cross contamination?
* From Known to Reasonably Foreseeable: Rethinking Biological Hazard Identification in Food Safety Programs
* Food Safe Facility Drainage Design
Organized by Food Safety Tech, who also runs the Food Safety Consortium Conference since 2012, the Food Safety Hazards Conference will focus on the detection, mitigation, control and regulations of food safety hazards through technology, best practices and data analytics. The Hazards addresses in the program include Listeria, e-Coli, Salmonella, Allergens, Chemicals and Foreign Matter. The conference scope includes both human and pet foods. The complete agenda, speakers and registration information is on the Food Safety Hazards Conference website.
The Food Traceability Rule establishes additional recordkeeping requirements, beyond those in existing regulations, for those who manufacture, process, pack, or hold foods FDA has designated for inclusion on the Food Traceability List. The final rule requires such entities to maintain records containing information on critical tracking events in the supply chain for these designated foods, such as initial packing, shipping, receiving, and transforming these foods. The requirements established in the final rule will help FDA rapidly and effectively identify recipients of these foods to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death.
Questions and Answers Guidance on the Food Traceability Rule
The guidance issued includes questions and answers to assist industry with understanding the scope of the Food Traceability Rule and meeting the requirements of the rule. The guidance addresses several topics, including:
Applicability of the rule to entities such as farms, farmers’ market stalls, fishing vessels, first land-based receivers, retail food establishments, and restaurants;
Applicability of the rule to activities such as intracompany shipments, commingling, initial packing, and transformation, including answers to questions about breaking pallets and culling produce;
Details about the exemption for raw molluscan shellfish;
Determining if a product is “fresh-cut” for the purpose of identifying whether it is on the Food Traceability List; and
Additional information on the food traceability plan and recordkeeping requirements.
Finalizing Exemption for Certain Cottage Cheese Products from the Requirements of the Food Traceability Rule
In the preamble to the final Food Traceability Rule, FDA announced its intention to consider initiating a process to exempt certain cottage cheese products from the rule. In 2024, FDA published a notice proposing to exempt Grade “A” cottage cheese that appears on the Interstate Milk Shippers (IMS) List (“IMS listed Grade “A” cottage cheese”) from the rule. FDA published a notice announcing that they are finalizing that exemption.
Much of the cottage cheese produced in the U.S. is regulated through the National Conference on Interstate Milk Shipments (NCIMS). FDA and NCIMS have together developed a cooperative, Federal-State program (the IMS Program) to ensure the sanitary quality of milk and milk products shipped interstate. The IMS program relies on the Pasteurized Milk Ordinance (PMO), which represents the most current science-based knowledge and experience concerning the safe production and processing of Grade “A” milk products, including cottage cheese.
After considering the comments on the proposal, FDA has concluded that the exemption is warranted because the processing requirements specified in the PMO for IMS listed Grade “A” cottage cheese address the risk factors that resulted in cottage cheese being included on the Food Traceability List, and because of the enhanced oversight of the manufacturing of IMS listed Grade “A” cottage cheese through the IMS program. In keeping with the statutory and regulatory provisions that allow for this type of exemption, facilities required to register with FDA that manufacture, process, pack, or hold IMS listed Grade “A” cottage cheese will still be required to maintain records identifying the immediate previous source of such food and the immediate subsequent recipient of such food.
Stakeholder Engagement Sessions
The FDA is also announcing a series of engagements with stakeholders, organized by the Partnership for Food Traceability (PFT), to fulfill a directive from Congress in the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act of 2026. FDA will engage quarterly with regulated entities, including farms, restaurants, retail food establishments, and warehouses distributing to retail food establishments and restaurants, to better understand concerns and explore options for assisting regulated entities with complying with the Food Traceability Rule. The PFT and FDA will hold a series of listening sessions on these topics. The sessions will include opportunities for public input as well as smaller group discussions. The listening sessions will provide an opportunity to engage with FDA on Food Traceability Rule implementation of lot-level tracking, challenges facing regulated entities, and potential solutions. The first session will take place March 6, 2026, for PFT members, with a public session the following quarter. Additional sessions will be announced as they are scheduled.
The webinar will discuss how to avoid complacency through proactive, ongoing reinforcement of organizational values. Webinar participants will include Sean Leighton, Global Vice President of Food Safety, Quality and Regulatory at Cargill and Sarah Nayani, Director of Compliance with Arctic Storm Management, as well as speakers from FDA and the Alliance to Stop Foodborne Illness.
This is the third in the ongoing series of interactive, hour-long webinars throughout the year designed to deepen your knowledge and strengthen your commitment to food safety. Each session will feature industry experts who will share valuable insights, real-world tools and actionable strategies to enhance food safety culture across your organization.
Click this link to view the complete list of webinars and reserve your spot for the rest of the series.
FDA’s Human Foods Program (HFP) released its priority deliverables for 2026. As part of HFP’s comprehensive plan, these targeted deliverables represent more than incremental progress; they signal a transformation in how HFP fulfills its mission to protect and enhance public health.
According to a press release, in 2026, HFP will build on accomplishments in 2025, guided by the three risk pillars, to strengthen and shape the next phase of FDA’s efforts. Throughout this year, FDA intends to provide periodic updates on their progress.
The planned activities include:
Food Chemical Safety: Improving the safety of food ingredients by systematically reviewing and, where appropriate, banning additives from the food supply.
Nutrition: Helping to reduce the prevalence of diet-related chronic disease by increasing transparency and empowering consumers to make informed choices through enhanced food labeling, such as front-of-package nutrition labeling; and expanding options for safe, reliable, and nutritious infant formula for American families through Operation Stork Speed initiatives.
Microbiological Food Safety: Enhancing food safety by advancing strategies and best practices for preventing contamination in human foods, strengthening protection by leveraging state oversight to complement FDA’s resources, and improving transparency of FDA’s regulatory and enforcement decisions.
In line with these 2026 priorities, HFP is also publishing its proposed 2026 guidance agenda to increase transparency of their work and processes, enhance food safety, and empower consumer nutrition choices, including the following impactful public health actions:
Establishing action levels for cadmium and inorganic arsenic in infant and young children’s foods, plus issuing guidance on preventive controls for chemical hazards.
Issuing guidance to assist industry in implementing effective sanitation controls consistent with the Preventive Controls for Human Food rule.
Issuing guidance to assist with food labeling for online grocery store platforms to give consumers access to nutrition information wherever they shop.
FDA states its goals for 2026 are ambitious, but claims HFP has the dedication, knowledge, and experience to tackle them.
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