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The FY 2022 Budget provides $1.6 billion in budget authority for food safety, an increase of $134 million, across human and animal products.

Of the increase of $134 million for food safety activities, $45 million is for efforts to support initiatives to advance the New Era of Smarter Food Safety, including $23 million for food safety requested as part of FDA’s Data Modernization and Enhanced Technologies initiative. The New Era initiative, announced in 2019, strives to leverage new technologies and approaches to create a more digital, traceable, and safer food system.

The budget also supports critical food safety initiatives that include $20 million for Emerging Chemical and Toxicology Issues, and $18 million for Maternal and Infant Health and Nutrition.

Additional funding will support the agency in keeping pace with the latest advances in science and technology and addressing issues of concern, such as maternal and infant health and nutrition and emerging chemical and toxicology issues. Likewise, without new resources for the New Era of Smarter Food Safety, the FDA's ability to maintain the safeguards needed to help keep foods safe will significantly lag behind rapid, sweeping changes in the marketplace, potentially putting consumers at risk.

As the New Era of Smarter Food Safety blueprint states: “Many believe we will see more changes in the food system over the next 10 years than we have over the past several decades. Foods are being reformulated, new foods and new food production methods are being realized, and the food system is becoming increasingly digitized. We believe modern times require modern approaches.”

The FY 2022 food safety budget request also includes $54 million to support agency-wide capacity-building and infrastructure investments. Please see the FY 2022 FDA President’s Budget for more details on these agency-level investments.

Key Accomplishments

New Era of Smarter Food Safety

In July 2020, the FDA released the New Era of Smarter Food Safety Blueprint, which outlines the steps that FDA will take over the next decade to enhance food traceability, strengthen predictive analytics, promote best practices for food safety for new models of producing and delivering foods, reduce risks seen in retail food operations, and support the establishment of food safety cultures. This approach builds on the progress that continues to be made in the agency’s implementation of the FDA Food Safety Modernization Act (FSMA), while advancing the use of technologies that are currently used in society and business sectors all around us, such as blockchain, sensor technology, the Internet of Things, and artificial intelligence. The COVID-19 pandemic has accelerated the need for many of the goals in the blueprint, such as enhancing traceability to speed outbreak response and help industry create more digital, agile, and resilient supply chains, exploring the use of remote and virtual food inspections, exploring ways to address safety vulnerabilities for foods increasingly ordered online, and supporting strong food safety cultures on farms, in facilities, and in homes.

Food Supply Chain Continuity and Vaccine Distribution to Food and Agriculture Workers

To help ensure the continuity and resiliency of the food and agriculture sector, the FDA developed a new data analysis tool called 21 Forward to provide a comprehensive, data-backed understanding of how COVID-19 is currently impacting the food supply chain. Utilizing a combination of FDA and U.S. Department of Agriculture (USDA) data and Centers for Disease Control and Prevention (CDC) forecasting for COVID-19, the 21 Forward platform is used to help the FDA identify where there may be risks for interruptions in the food supply chain with the goal of conducting targeted outreach to the food industry to offer additional resources and consultations with FDA subject-matter experts. In collaboration with the Department of Health and Human Services, CDC, and USDA, data from 21 Forward are also being made available to assist states with their planning efforts for vaccine distribution to workers in the food and agriculture sectors. 

Produce Safety

In March 2020, the FDA released the Leafy Greens STEC Action Plan to foster a more urgent and collaborative approach to preventing outbreaks of foodborne illness associated with the consumption of leafy greens. While millions of servings are consumed safely every day, fresh leafy greens have been repeatedly implicated in outbreaks of foodborne illness caused by Shiga toxin-producing E. coli, or STEC. While most strains of E. coli are harmless, STEC infections can be life-threatening. Between 2009 and 2018, the FDA and CDC identified 40 foodborne outbreaks of STEC infections with a confirmed or suspected link to leafy greens in the United States.

In 2020, the FDA made significant progress on the Leafy Greens STEC Action Plan by enhancing prevention strategies, improving response activities by the agency and other entities, and identifying and addressing the knowledge gaps that exist around STEC contamination of leafy greens. The FDA launched the California Longitudinal Study, collaborated with the Environmental Protection Agency (EPA) in its development of an efficacy protocol for the registration of antimicrobial treatments for pre-harvest agricultural water, and took critical steps to advance traceability of leafy greens. The FDA worked with the California Department of Agriculture to conduct several focused inspections, follow-up investigations, and sampling assignments to determine and evaluate potential sources of contamination.

In April 2021, the FDA took additional steps to advance the safety of leafy greens. The FDA released a report on the investigation into the fall 2020 outbreak of E. coli O157:H7 illnesses linked to the consumption of leafy greens. The report describes findings from the investigation, as well as trends key to understanding leafy greens outbreaks linked to the California Central Coast growing region (encompassing the Salinas Valley and Santa Maria growing areas) that have occurred every fall since 2017. The trends include the identification of a recurring strain of E. coli, and recurring issues around the presence of cattle on adjacent land.

The FDA also released an updated version of the Leafy Green STEC Action Plan, reaffirming the need for collaborative action to improve the safety of leafy greens, and building on the work accomplished in 2020. The updates for 2021 include a renewed emphasis on actions to help prevent contamination from adjacent land, and new actions that build on the accomplishments and learnings from the 2020 plan. They also renew our commitment to actions that were difficult to accomplish in 2020 due to challenges presented by the COVID-19 pandemic.

FDA-Mexico Food Safety Partnership

In October 2020, the United States and Mexico officially launched the FDA-Mexico Food Safety Partnership (FSP), broadening and strengthening the scope of our existing partnership to include the safety of all human food regulated by the FDA. The earlier Produce Safety Partnership, signed in 2014, had created a framework for Mexico and the U.S. to work together to contain potentially serious outbreaks related to produce and to lessen consumer exposure to foodborne disease.  The FSP embraces the use of new and emerging technologies, including elements of the FDA’s New Era of Smarter Food Safety initiative, to solve complex public health challenges. Further, it strengthens collaboration with academia, consumer groups, and other governmental offices in the U.S. and Mexico.

Increasing the Safety of Foods for Babies and Young Children

In March 2021, the FDA issued a letter to baby and toddler food manufacturers and processors covered by the preventive control provisions of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule. The letter reminds them of their existing responsibility to consider risks from chemical hazards—including toxic elements—when conducting a hazard analysis.

In April 2021, the FDA announced a comprehensive plan to further reduce levels of toxic elements such as lead, cadmium, mercury, and arsenic in foods for babies and young children. The “Closer to Zero: Action Plan for Baby Foods” identifies actions the agency will take to reduce exposure to toxic elements from foods eaten by babies and young children to as low as possible. The FDA has prioritized babies and young children because their smaller body sizes and metabolism make them more vulnerable to the harmful effects of these contaminants.

In addition, research has shown that reducing exposure to toxic elements is important to minimizing any potential long-term effects on the developing brains of infants and children. 

Consumer Education Initiatives

The Center for Food Safety and Applied Nutrition (CFSAN) launched two new consumer education campaigns in 2020.

In March 2020, the FDA announced “The New Nutrition Facts Label: What’s in it for You?” education campaign, which was developed to raise awareness about the changes to the Nutrition Facts label, increase its use, and help consumers, health care professionals, and educators learn how to use it as a tool for maintaining healthy dietary practices. The education campaign includes outreach through many channels including social media, indoor/outdoor advertising, videos, and consumer-friendly downloadable educational materials.

In March 2020, the FDA also launched the “Feed Your Mind” initiative in partnership with the U.S. Department of Agriculture and the U.S. Environmental Protection Agency (EPA) to provide science-based information on genetically engineered foods, commonly called GMOs. The campaign features a wide range of resources designed specifically for consumers, health care professionals and students.  These materials feature new web content, fact sheets and videos, engaging graphics and stories to provide information about genetically engineered foods.  This initiative is an ongoing effort, with additional materials planned for release later in 2021.

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The FDA will invest across the centers and offices involved in its foods program to make improvements in key areas related to food safety and nutrition. One of those areas is the New Era of Smarter Food Safety.

The goal of the New Era of Smarter Food Safety initiative, as outlined in the blueprint released on July 13, 2020, is to bend the curve of foodborne illness in this country by reducing the number of illnesses. The New Era envisions leveraging  the use of new and emerging technologies and approaches to help enhance traceability, improve predictive analytics, expand collaboration with our regulatory and public health partners when possible, respond more rapidly to outbreaks, explore ways to address new business models (such as online ordering and direct delivery of foods, which has accelerated during the COVID-19 pandemic), advance the safety of foods sold in traditional retail establishments, and foster strong food safety cultures.

This approach builds on the modernized food safety regulatory framework created by the FDA Food Safety Modernization Act (FSMA) and is closely connected with FDA’s response to the unprecedented challenges of the COVID-19 pandemic by helping to ensure the safety of food and prevent disruptions in the food supply when public health emergencies arise in the future.

Among the ways in which the FDA will work toward the goals of the New Era of Smarter Food Safety, the agency will invest in enhanced technologies and data analytics to strengthen prevention of human and animal foodborne illnesses, enable food contamination to be rapidly traced to its source, and better understand food safety challenges. The FDA’s request for New Era funding includes the $22.8 million food safety component of the agency’s Data Modernization and Enhanced Technologies initiative.

The FDA will promote and support industry adoption of new traceability technologies and invest in predictive analytics to ensure that FDA can receive, efficiently process, and share new data streams, particularly in emergency response and outbreak scenarios. Improved traceability will help FDA respond more quickly to outbreaks, as well as expedite recalls. Beyond outbreaks, the current lack of traceability is also a barrier to the transparency needed to create in the long-term a more resilient and interoperable food system that can nimbly adjust supply chains during public health crises, such as the COVID-19 pandemic.

The FDA’s investment in the New Era of Smarter Food Safety will also strengthen the animal food inspection system. Domestic mutual reliance is a critical component of the New Era of Smarter Food Safety as it strengthens partnerships with states to ensure optimal use of resources and maximize food safety reach.

Working through FDA’s  Center for Veterinary Medicine and the Office of Regulatory Affairs, the FDA will provide funding to the states to help them build modern, prevention-oriented systems. Animals have died and people have been sickened because animal food has been contaminated by preventable hazards. Historically, state partners have conducted up to 80% of the FDA’s animal food safety inspections. The FDA and its state partners need these resources to help us provide risk-based oversight for the existing inventory of approximately 34,000 animal food facilities subject to FDA’s food safety regulations, including the Preventive Controls for Animal Food rule established in part by FSMA.

Goals in FY 2022 Budget Authority Request Include:

• Goals in the New Era of Smarter Food Safety blueprint:
  • Tech-Enabled Traceability: Enhance preparations to implement the Food Traceability Rule to be published in late 2022.
  • Smarter Tools and Approaches for Prevention and Outbreak Response: Formalize root cause analysis procedures with federal, state, local, tribal, and territorial partners to broaden the use of rapid deployment tools. Further develop new predictive analytical capabilities to integrate rules-based and machine learning systems to target potential sources of public health concern. Increase investments in domestic mutual reliance to create a more comprehensive food safety oversight system. (See Goals for Domestic Mutual Reliance/Animal Food Safety Oversight below.)
  • New Business Models and Retail Modernization: Conduct outreach with stakeholders and complete an evaluation of the current regulatory landscape to assess needs for future guidance, education and outreach efforts, and compliance activities to support new business models.
  • Food Safety Culture: Develop food safety culture goals, including learning about tools available for assessing and measuring progress. Develop and launch internal training for FDA inspectional staff on the behavioral and organizational principles of food safety culture.
  • Cross-cutting Investments: Meet the goals of the blueprint by strengthening project management capabilities, IT development support for critical analytics tools, and stakeholder engagement. This initiative also includes funding for FDA’s National Center for Toxicological Research to work on the development of data-driven tools to better understand foodborne pathogens.
• Goals for Domestic Mutual Reliance/Animal Food Safety Oversight:
  • Provide funding to states to expand efforts to modernize, harmonize, and transform the U.S. animal food inspection system into one that is comprehensive and preventive.
  • Update inspection and enforcement programs, develop outreach and training initiatives, and devote resources to the analysis of controls for expected animal food hazards and to understanding unknown animal food hazards.

Accomplishments Achieved with Current FY 2021 Funds

• In September 2020, the FDA issued the Food Traceability Proposed Rule. This proposed rule, mandated by FSMA, is also part of the New Era of Smarter Food Safety. Following the publication of the proposed rule, the FDA conducted three public meetings to discuss the proposal and accepted public comments through the Federal Register. The proposed rule, when finalized, would establish a standardized approach to traceability recordkeeping for certain designated foods. While the proposed rule would not require electronic recordkeeping, it would pave the way for industry to adopt, harmonize, and leverage more digital traceability systems in the future.
• As part of efforts to better leverage predictive analytics, the FDA implemented a pilot program to understand the abilities of artificial intelligence (AI), specifically machine learning (ML), to rapidly analyze data for screening foods imported into the United States. In August 2020, the FDA announced the results of the proof-of-concept for imported seafood, which demonstrated that machine learning could almost triple the likelihood of identifying a shipment containing potentially contaminated products. In February 2021, the FDA launched the second phase of the AI/ML imported seafood pilot, applying the model to field conditions.

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The FDA will invest across the centers and offices involved in its foods program to make improvements in key areas related to food safety and nutrition. One of those areas is Emerging Chemical and Toxicology Issues.

Over the last decade, the FDA has placed a major emphasis on implementing the 2011 FDA Food Safety Modernization Act (FSMA), which sets requirements for industry and transformed the nation’s food safety laws for the first time since the 1930’s. In that time, however, many food safety programs, such as pre-market programs and our capacity to mitigate risk due to chemical hazards across our products, which fall mostly outside of FSMA’s purview, have been falling further behind in their ability to keep pace with increasing innovation by industry and advances in science.  Data gaps exist in understanding the thousands of chemicals that are contained in foods, dietary supplements, and cosmetics, and the FDA needs additional resources to identify, prioritize, and manage the smaller subset of potentially dangerous chemicals that may present health hazards.

These programs have received little if any new funding during the last 10 years and there is a critical need for resources to modernize and streamline regulatory frameworks for products that in certain cases pose potential chronic risks to human health. With new resources, the FDA will enhance and update its approach to chemicals—both those directly added as food ingredients and those that come into the food supply through food contact and environmental contamination.  In addition, FDA will work on issues such as: food additives and substances added to food, and chemicals used in food contact, such as phthalates, as well as allergens, dietary supplements, and contaminants in cosmetics, which continue to receive major attention from the public as new potential health concerns emerge. Without significant new resources to address these critical issues the FDA will be unable to acquire and use emerging science and risk-based assessments to ensure food and cosmetic safety and protect public health.

Goals in FY 2022 Budget Authority Request Include:

• Hiring additional experts
  • Increased staffing will build capacity to use science and information technology advances to make product safety determinations more quickly.
  • The FDA will recruit additional experts such as toxicologists and environmental scientists to help detect per- and Polyfluoroalkyl Substance (PFAS) in the food supply, understand associated risks, and reduce the public’s exposure to those health risks. PFAS are human-made chemicals that have been used in consumer and industrial products because of their resistance to grease, oil, water, and heat. Some PFAS have  been shown to accumulate in the human and animal body and, evidence suggests, may cause serious health conditions.
  • The FDA needs additional staff to assess the public health importance of allergens other than the nine major food allergens for which additional controls may be needed, including manufacturing controls and labeling. Staff are also needed to develop and implement new allergen and gluten testing methods and conduct additional research to inform the FDA’s regulatory work on allergens and gluten.
• Supporting data- and risk-based safety evaluations
  • Additional funding will enable the FDA to acquire new tools to support science- and risk-based pre-market and post-market safety evaluations. 
• Monitoring the food supply
  • The goal is to identify, manage, and gather relevant toxicology data on the smaller subset of potentially dangerous chemicals that may present public health hazards.
• Supporting cosmetics and dietary supplement programs
  • New funding would provide modest increases to FDA’s programs for cosmetics and dietary supplements.

Accomplishments Achieved with Current FY 2021 Funds

• The FDA has initiated a comprehensive review of available toxicological data on PFAS to determine which information is applicable to the specific PFAS chemicals found in food and to use this information to both assess exposures and determine if actions are needed to address safety concerns.
• In March 2021, the FDA issued a Consumer Update and Fact Sheet warning consumers  about the potential hazards of formaldehyde in hair smoothing products. Currently, the agency has formed a working group to formulate next steps to take.

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The FDA will invest across the centers and offices involved in its foods program to make improvements in key areas related to food safety and nutrition. One of those areas is Maternal and Infant Health and Nutrition.

Nutrition during pregnancy and in early childhood is critically important in supporting health and wellbeing of mothers and their children. Establishing healthy dietary patterns in early childhood can influence eating behaviors and health throughout life. Nutrients vital for brain development and growth must be provided in adequate amounts during early years and certain dietary constituents should be limited or avoided to prevent potentially irreversible harm. Infants, young children, and the developing fetus are especially vulnerable to toxic elements (e.g., lead, cadmium, arsenic, and mercury) due to small body size and rapid growth and development. In addition, research has shown that reducing exposure to toxic elements is important to minimizing any potential long-term effects on the developing brains of infants and children.

FDA’s food and nutrition programs are well-positioned to make progress in maternal and infant health and nutrition. The requested resources will facilitate FDA’s  regulatory and other actions to address issues of concern, such as toxic elements in foods consumed by babies and young children; premarket review of infant formula submissions to evaluate the safety and nutritional adequacy of infant formula, for which there is limited staff review capacity; and nutrition work specific to infants, toddlers, and pregnant and lactating women. The FDA is uniquely positioned to address these critical areas and meaningful progress will be accelerated by an infusion of new resources to perform this work.

Toxic metals such as lead, arsenic, mercury, and cadmium are present in water, and soil, so some exposure through food is unavoidable, but exposure for infants and young children could potentially be reduced. These actions can also work to advance health equity. Improving awareness of how to achieve healthy dietary patterns while reducing toxic elements during pregnancy and for infants and young children is likely to benefit to a greater degree certain racial, ethnic and socioeconomic subgroups, who may be at increased risk for nutrition-related chronic diseases and dietary exposure to toxic elements.

Goals in FY 2022 Budget Authority Request Include:

• Increase staffing
  • With additional resources, the FDA will recruit risk analysts, consumer safety officers, data analysts, public health information specialists, toxicologists, and chemists, among others.
  • Increased staffing in these areas will allow the FDA to expand research on the occurrence of multiple toxic elements in foods and impacts on the development of the nervous system and evaluate how laboratory procedures and methods can be improved to detect levels of concern.
• Establish action levels for toxic elements
  • The FDA plans to establish reference levels for exposure to toxic elements from foods, set expectations to strive for continual improvement, and provide action levels with the expectation that, if supported by the evidence, they will decrease over time for lead, arsenic, cadmium, and mercury for different categories of foods consumed by babies and very young children.
  • The FDA is scheduled to publish a draft guidance that will establish action levels for lead in juice.
    • (Action levels are a level of contamination at which a food may be regarded as adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic (FD&C) Act. The FDA considers action levels, in addition to other factors and scientific evidence, when considering whether to bring enforcement action in a particular case. A reference level is a measure of exposure to a substance from food that the FDA may use to determine if the amount of exposure to an individual substance across foods could result in a specific health impact.)
• Develop communications materials and guidance
  • Increased resources will also allow the FDA to create risk communication and education materials for consumers on the risks from toxic elements in foods, and the importance of healthy dietary patterns and variety as a strategy for reducing toxicants in the diet.
  • The FDA will also develop education and outreach materials for industry which outline ways to manage and minimize the presence of toxic elements in their products.
• Review infant formula submissions
  • Infant formula is a significant or even sole source of nutrition for many infants during a critical period of growth and development. Increased resources will allow the expansion of agency capacity to review the increasing number, size, and complexity of infant formula submissions.
    • Under the FD&C Act and implementing regulations, a person who introduces or delivers for introduction into interstate commerce a new infant formula must provide to FDA, at least 90 days before marketing such new infant formula, a submission that includes information about the formulation and assurances relating to its manufacture.
• Promoting understanding of the Dietary Guidelines for Americans
  • The FDA will partner with USDA, other agencies in the Department of Health and Human Services and others to explore opportunities to better help consumers understand information contained in the new 2020-2025 Dietary Guidelines specific to pregnant and lactating women and early childhood while also reducing dietary exposure to toxic elements. 

Accomplishments Achieved with Current FY 2021 Funds

• Letter to manufacturers and processors of baby and toddler food
  • In March 2021, the FDA issued a letter to baby and toddler food manufacturers and processors covered by the preventive control provisions of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule. The letter reminds them of their existing responsibility to consider risks from chemical hazards—including toxic elements—when conducting a hazard analysis.
• Closer to Zero
  • In April 2021, the FDA announced a comprehensive plan to further reduce levels of toxic elements such as lead, cadmium, mercury, and arsenic in foods for babies and young children. The “Closer to Zero: Action Plan for Baby Foods” identifies actions the agency will take to reduce exposure to toxic elements from foods eaten by babies and young children to as low as possible.