FSMA Fact Sheet
Implementation of the Food Safety Modernization Act (FSMA) in 2014 will have an impact on the production, distribution and transportation of food in the United States. According to the FDA, which will oversee the new regulations, “the legislation transforms FDA’s approach to food safety from a system that far too often responds to outbreaks rather than prevents them. It does so by requiring food facilities to evaluate the hazards in their operations, implement and monitor effective measures to prevent contamination, and have a plan in place to take any corrective actions that are necessary.”
The impact on the manufacturing sector is going to be significant. Among the requirements in the FSMA that affect manufacturing:
Mandatory preventive controls for food facilities: Food facilities are required to implement a written preventive controls plan. This involves:
- Evaluating the hazards that could affect food safety
- Specifying what preventive steps, or controls, will be put in place to significantly minimize or prevent the hazards
- Specifying how the facility will monitor these controls to ensure they are working
- Maintaining routine records of the monitoring
- Specifying what actions the facility will take to correct problems that arise.
Mandatory produce safety standards: The FDA must establish science-based, minimum standards for the safe production and harvesting of fruits and vegetables. Those standards must consider naturally occurring hazards, as well as those that may be introduced either unintentionally or intentionally, and must address soil amendments (materials added to the soil such as compost), hygiene, packaging, temperature controls, animals in the growing area and water.
Authority to prevent intentional contamination: The FDA must issue regulations to protect against the intentional adulteration of food, including the establishment of science-based mitigation strategies to prepare and protect the food supply chain at specific vulnerable points. (Final rule due 18 months following enactment)
Among the new tools covering inspection are:
- Mandated inspection frequency: The FSMA establishes a mandated inspection frequency, based on risk, for food facilities and requires the frequency of inspection to increase immediately. All high-risk domestic facilities must be inspected within five years of enactment and no less than every three years thereafter. Within one year of enactment, the law directs FDA to inspect at least 600 foreign facilities and double those inspections every year for the next five years.
- Records access: FDA will have access to records, including industry food safety plans and the records firms will be required to keep documenting implementation of their plans.
- Testing by accredited laboratories: The FSMA requires certain food testing to be carried out by accredited laboratories and directs FDA to establish a program for laboratory accreditation to ensure that U.S. food testing laboratories meet high- quality standards.
For specific information about FSMA, go to the FDA Website, www.fda.gov.