The recently enacted Food Safety Modernization Act (FSMA), the first major overhaul of our food safety law in over 70 years, will transform FDA’s food safety program by providing it with new public health mandates and enhanced tools for ensuring the safety of the food supply in the 21st Century. FSMA emphasizes the concept of preventing problems before they occur and provides new tools to require manufacturers to implement prevention plans. Additionally, FSMA requires FDA to respond quickly and effectively when problems do occur.
FSMA mandates a new approach to FDA’s current food safety system, emphasizing prevention and risk-based priority setting and resource allocation to address the challenges of the modern food safety environment. Although prevention is paramount, enhanced response and investigation efforts to foodborne outbreaks when they occur, is also critical. To effectively implement this new food safety mandate, it is imperative that FDA ensures a strong science infrastructure, clearly identifies its research needs, and collaborates with other public health and research agencies in the Federal government, state government agencies, academia, and private industry. Specifically, FDA will focus on the following:
- Establish and implement centralized planning and performance measurement processes:
- Establish and implement Foods Program science/research strategic planning and operational planning processes;
- Develop mechanisms to identify and prioritize research needs critical to achieving the Agency’s public health and consumer protection goals;
- Harmonize microbiological and chemical analytical methods development and validation across the Foods Program to enhance detection and removal of unsafe contaminants from the Nation’s food and feed supply; and
- Plan and implement ongoing collaborative activities between science and research elements of programs and Centers and Federal and State partners where appropriate.
- Improve information sharing internally and externally:
- Effectively communicate research plans and results within the Foods Program to Federal and State partners, the public, and other interested stakeholders;
- Develop centralized IT infrastructure to collect, analyze, and share foods science/research data with program offices;
- Evaluate the impact of publications and presentations on the scientific and regulatory community; and
- Improve communication with food importers to provide rapid notification of negative test results.
- Maintain mission critical science capabilities:
- Identify and invest in disciplines and specialties that are critical to carrying out the Foods Program mission;
- Identify and invest in emerging disciplines, sciences, and technologies to mitigate future risks in food safety (also see section 4); and
- Maintain and enhance the science/technology infrastructure to support day-to-day operations. This will ensure the infrastructure exists at FDA to promptly recognize, evaluate, and ensure effective controls for food and feed safety hazards (microbiological, chemical, and radiological).
- Cultivate expert institutional knowledge:
- Develop integrated Foods Program training requirements and training program for cross-functional scientific staff.
As a regulatory agency tasked to ensure the safety of the nation’s food supply, it is imperative that the analytical methods our laboratories employ for surveillance, compliance, and outbreak investigations meet the highest standards of performance. FDA is meeting this challenge through the development of performance standards for all methods to detect microbial pathogens and chemical and radiological contaminants, and to harmonize method validation guidelines for all methods developed and used in our testing laboratories. Currently, guidelines to govern analytical methods designed to detect food-borne microbial pathogens are nearing completion and will cover methods for the detection of food-borne bacterial pathogens (e.g. Salmonella, Listeria, Shigella, etc.) viruses (e.g. Hepatitis A virus, Norovirus) and other pathogens (e.g. Cyclospora and Cryptosporidium). These guidelines will also address performance evaluation criteria (verification and validation) necessary for the use of commercially-available microbiological diagnostic kits and platforms in FDA regulatory laboratories. At the same time, FDA is also actively collaborating with other government agencies, international partners, and multiple accrediting bodies to achieve a similar consensus on method performance standards and validation criteria. As collaborative global food safety surveillance programs increase, harmonization of standards and validation criteria will allow for greater data sharing and data acceptance between the US and our international trading partners.
Public Health Impact:
An integrated science/research program based on the principles of prevention and risk-based priority setting provides research solutions to support current and evolving FDA regulatory issues and is critical to meet FDA regulatory science priorities outlined in this initiative. The investment in this public health focus will strengthen FDA’s ability to prevent the occurrence of future food and feed safety contamination events, and if necessary, quickly respond to microbial and chemical contamination events. This initiative will also allow for greater collaboration and coordination between operating divisions under the umbrella of the Office of Foods (i.e., CFSAN and CVM) and components of ORA and NCTR, and will enable FDA to meet emerging challenges in the food safety arena.