May 2015

Biennial Report to Congress on the Food Safety and Food Defense Research Plan
Submitted Pursuant to Section 110(g) of the FDA Food Safety and Modernization Act (P.L. 111-353)
U.S. Department of Health and Human Services
Food and Drug Administration

Download the Full Report (PDF: 1.36MB)

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While the responsibility for food safety and the protection of the nation’s food and agriculture supply against unintentional and intentional contamination and other emerging threats is an important responsibility shared by federal, state, local, tribal, and territorial governments and private sector partners, the principal responsibility lies with the Department of Health and Human Services (HHS), the United States Department of Agriculture (USDA), and the Department of Homeland Security (DHS). Research to support food safety and food defense efforts is primarily conducted by several agencies within these departments (e.g.,at HHS, the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), at USDA, the Agricultural Research Service (ARS), the Economic Research Service (ERS), the Food Safety Inspection Service (FSIS), and the National Institute of Food and Agriculture (NIFA), as well as by various academic institutions primarily funded through federal grants and collaborative agreements. These agencies are positioned to contribute science-based information to public health decision making and policymaking that will ultimately help improve the safety and security of the food supply. In addition to federally supported research, private industry, particularly food companies, conduct research to assist them in developing and updating their company-based food safety programs. However, there is a clear need for the development of additional public-private research partnerships with regards to identifying priorities and mitigation strategies aimed at improving food safety.

Identifying and conducting science and research to support foodborne illness reduction strategies is a challenging and constant undertaking due to the complexity and continual evolution of food production and processing practices, food distribution, and consumer preferences and practices. In addition, new foodborne hazards continue to emerge, and others that have existed for some time are being found in foods not historically associated with a particular foodborne pathogen. Recent data on foodborne illness from CDC illustrate that many food safety issues persist and that we need to be alert to new challenges since many hazards can be transmitted through a variety of foods.

As food safety knowledge and activities have evolved, the objectives of the federal agencies responsible for the safety and security of the food supply have as well. The research goals across these agencies provide both broad and focused strategic approaches depending on their respective regulatory responsibilities. Their range provides the opportunity to develop research applicable to addressing current recognized foodborne microbial and chemical contaminant risks and threats, while also providing the framework for research and extension activities to address long-term, as well as emerging needs. As technologies and methods advance, new pathogens and chemical contaminants are often identified. Examples of salient issues of concern, both existing and emerging, include produce food safety, the detection and characterization of chemical (or bio-threat) contaminants, the potential effects from climate change on food safety, and the development and evaluation of prevention and intervention strategies along the food production continuum. Bringing this to the forefront was the enactment in 2011of the FDA Food Safety and Modernization Act (FSMA or the Act) (Public Law 111-353), which calls for a science-based, public health, prevention-oriented food safety system, and the establishment of an infrastructure needed to support such a system as well as identifying and highlighting the critical role science and research will continue to play in ensuring a safe food supply.

Continuation of mission critical research is essential for supporting science-based prevention standards, understanding and detecting foodborne hazards, and developing intervention strategies to protect the U.S. food supply and consumers. This report highlights food safety research being conducted or supported by individual agencies as well as collaborations among federal agencies. For the purposes of meeting the reporting requirement in section 110(g) of FSMA, research projects have been divided into eight general categories:

• Prevention, intervention, and control of foodborne hazards;
• Detection of microbial, chemical, and radiological hazards in food, feed, and dietary supplements;
• Molecular characterization of foodborne pathogens as it relates to research on the mechanism of disease and/or epidemiology of foodborne disease;
• Antimicrobial resistance/susceptibility of foodborne microorganisms;
• Designed epidemiologic studies of foodborne illness/associated organisms;
• Risk assessment, modeling, management, and communication;
• Safety assessments of foodborne hazards, including toxicological studies; and
• Economic analysis.

The federal government has invested significant resources to maintain and build its scientific foundation in these areas and each agency is increasingly prioritizing food safety research needs in alignment with their respective public health goals and mission.

Of note is the FSMA requirement in section 108 that calls for the development of a National Agriculture and Food Defense Strategy (NAFDS) that details specific food and agriculture defense goals, objectives, key initiatives, and activities to be accomplished by HHS (primarily FDA), USDA, DHS, and other stakeholders. The Act also mandates that the NAFDS shall include a coordinated research agenda for use by the Secretaries of HHS and Agriculture in conducting research to support its goals and activities. To avoid duplication of efforts, the agencies have agreed that the food defense research activities and plans will be captured as part of the FSMA section 108 requirement and the section 110(g) Biennial Food Safety and Food Defense Research Plan and will focus on broad food safety activities, with cross-reference to the NAFDS for the food defense research activities, as appropriate.

The federal agencies engaged in food safety research are involved at times in overlapping areas of research, albeit tailored to the individual needs and applicable laws under which each agency exists and operates. These needs are largely dictated by the different applications of research outcomes for public health regulation or public service. Hence, there are differences in the scope of the research, the technologies employed, and the ultimate use of the knowledge gained from research activities. Nevertheless, it is recognized that the FSMA legislation emphasizes more active engagement by the agencies in coordinating and integrating food safety research.

This report to Congress is the first step in documenting progress toward a coordinated, risk-based, and mission-critical federal food safety research strategy. Implementation of an enhanced, integrated approach to research will position the federal agencies to more effectively address the issues threatening the food supply. Strategically and operationally linking research needs to the regulatory goals of the agencies will create focused synergy and momentum and will increase the ability of the agencies to meet their public health goals. Fostering a culture of collaboration with other research and health agencies in the federal government, state government agencies, academia, private industry, and foreign regulatory counterparts will expand scientific capability and permit all stakeholders to benefit from the great strides being made nationally and internationally. With transparent, collaborative processes for prioritizing science and research needs, HHS, USDA, and DHS can collectively move forward strategically and achieve a clear and consistent focus on mutual goals while leveraging the regulatory and research capabilities of partners to help meet the highest priorities. These efforts will require significant investments in cutting edge technologies and expert human capital that strengthen science and technology infrastructure with the future in mind. Future reports will expand on progress made in prioritizing research areas, allowing for greater collaboration and coordination among the agencies, promoting integrated capacity-building among stakeholders, and facilitating more efficient leveraging of existing and future research resources.