The Food Safety Modernization Act
In January 2011, President Obama signed the Food Safety Modernization Act (FSMA) with the goal of shifting the federal government’s focus to preventing food safety issues, rather than relying primarily on responding to problems. The FSMA is directed at the Department of Health and Human Services (HHS). Most provisions apply to the FDA or require coordination among several federal agencies.21 For example, the FDA, USDA, and Department of Homeland Security must submit to Congress on a biennial basis a joint food safety and food defense research plan.22 The FSMA also requires the FDA to collaborate with state departments of health. Select collaborations among federal agencies are outlined in Table 5.2.
The FSMA contains many specific directions to the FDA; several interesting ones are noted here. Provisions of the FSMA require the FDA to engage in pilot projects to develop recommendations for improving the tracking and tracing of food and to work with the USDA to establish a product-tracing system that improves the capacity of the FDA to track and trace domestic or imported food effectively and rapidly.23 The FDA is required to enact comprehensive, science-based preventive controls including establishing science-based, minimum standards for the safe production and harvesting of produce, overseeing food facilities’ implementation of written preventive controls plans, and issuing regulations to protect against intentional food adulteration.24
- 21 21 USC 2202.
- 22 21 USC 2204.
- 23 21 USC 2223.
- 24 Food and Drug Administration Background on Food Safety Modernization Act. FSMA FACTS. July 12, 2011.
TABLE 5.2
Selected Collaborative Mechanisms Involving the Food and Drug Administration and USDA’s Food Safety and Inspection Service
|
Name |
Description |
|
Foodborne Diseases Active Surveillance Network (FoodNet) |
A collaboration involving the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), Food Safety and Inspections Service (FSIS), and 10 state health departments. It estimates the number of foodborne illnesses, monitors trends in incidence of specific foodborne illnesses over time, and attributes illnesses to specific foods and settings, among other things. |
|
Healthy People 2020 |
A national health promotion and disease prevention initiative that includes 42 topic areas, including food safety. FDA and FSIS co-lead the food safety topic area, with an objective of, among other things, reducing rates of infection caused by foodborne pathogens. |
|
Interagency Foodborne Outbreak Response Collaboration |
A collaboration involving CDC, FDA, and FSIS to coordinate foodborne illness outbreak investigations. |
|
Interagency Food Safety Analytics Collaboration |
A collaboration involving CDC, FDA, and FSIS focusing on projects related to foodborne illness source attribution, the process of estimating the most common food sources responsible for specific foodborne illnesses. |
|
Interagency Residue Control Group |
A collaboration involving the Environmental Protection Agency, FDA, FSIS, and other agencies to discuss and resolve chemical residue issues. |
|
Interagency Risk Assessment Consortium |
A collaboration involving federal agencies with food safety responsibilities. It works to promote scientific research that will facilitate risk assessments to assist regulatory agencies in fulfilling their specific food-safety risk management mandates. |
|
National Advisory Committee on Microbiological Criteria for Foods |
A collaboration involving CDC, FDA, FSIS, and other federal agencies with food safety responsibilities. It develops methodologies for assessing microbiological hazards in foods, among other things. |
|
National Antimicrobial Resistance Monitoring System |
A collaboration involving CDC, FDA, FSIS, and state and local health departments that tracks whether foodborne and other bacteria are resistant to the antibiotics used to treat and prevent the spread of illness. |
|
PulseNet |
A collaborative surveillance network involving CDC, FDA, FSIS, and public health laboratories in each state. PulseNet uses molecular fingerprinting to connect cases of foodborne infection and detect outbreaks. |
Source: GAO Report. GAO-15-180 Federal Food Safety Oversight. Additional Actions Needed to Improve. Table 3 http://www.gao.gov/assets/670/667656.pdf
The FSMA also requires the FDA to promulgate regulations to establish recordkeeping requirements for facilities that manufacture, process, pack, or hold foods designated as “high-risk foods.”25 The FDA issued a request for comments and scientific data and information in 2014 to determine which foods should be considered high-risk.[1] The FSMA specifies that the designation of high-risk foods must be based on the: (1) known safety risks of a particular food, including the history and severity of foodborne illness outbreaks attributed to such food, taking into consideration foodborne illness data collected by the Centers for Disease Control and Prevention; (2) likelihood that a particular food has a high potential risk for microbiological or chemical contamination or would support the growth of pathogenic microorganisms due to the nature of the food or the processes used to produce such food; (3) point in the manufacturing process of the food where contamination is most likely to occur; (4) likelihood of contamination and steps taken during the manufacturing process to reduce the possibility of contamination; (5) likelihood that consuming a particular food will result in a foodborne illness due to contamination of the food; and (6) likely or known severity, including health and economic impacts, of a foodborne illness attributed to a particular food.[1]
The FSMA also provided the FDA with new authority over imported food. Importers must verify that foreign food suppliers have preventive controls in place to ensure that the food they produce is safe.[3] Further, the FDA can deny entry of foods if the agency is not allowed to inspect the foreign facility (or enter the country in which it is located).[3]
- [1] Federal Register / Vol. 79, No. 23, pages 6596-6598 (February 4, 2014).
- [2] Federal Register / Vol. 79, No. 23, pages 6596-6598 (February 4, 2014).
- [3] Food and Drug Administration Background on Food Safety Modernization Act. FSMAFACTS. July 12, 2011.
- [4] Food and Drug Administration Background on Food Safety Modernization Act. FSMAFACTS. July 12, 2011.
