The Fundamentals of the Food Safety Modernization Act (FSMA)

The Food Safety Modernization Act (FSMA) was signed into law by President Obama on January 4, 2011 with the overarching goal of tackling food safety and preventing future outbreaks of food borne illnesses. While the Act was officially signed over three years ago, regulations and rules are still being developed and implemented by the Food and Drug Administration (FDA). The three main components the Act is attempting to tackle and improve are:

  1. Prevention
  2. Inspection and Compliance
  3. Response

Prevention in FSMA

For the first time in food safety history, the FDA will mandate science-based preventative controls among the food supply. Industries will be given discrete standards for worker health and hygiene, packaging, temperature controls, and water use. Organizations will be expected to provide a written plan specific to their food products, monitor those controls and establish a corrective actions if standards are not met.

The FDA will also establish science-based produce safety standards for safe production and harvesting of fruits and vegetables. These will include standards that address the quality of the soil used to grow these fruits and vegetables, various inputs to the soil, packaging, temperature controls, water and animals in the growing area.

Currently only guidance and proposed rules have been issued for these new facets of the law – most recently a proposed supplemental rule for Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food, which addressed issues such as what types of farms are subject to preventative control rules and circumstances for when facilities need to conduct product testing to verify establishment of preventative controls.

Inspection in FSMA

FSMA will require regulatory oversight by the FDA on the food industry in order to ensure compliance. FDA will be tasked with mandatory inspections based on the level of risk for a particular facility. High-risk facilities will be determined based on the vulnerability to intentional contamination and inspections will be conducted every three years. The FDA plans to enable a stronger partnership among State and local governments to ensure a standardized and efficient approach to these inspections.

Response in FSMA

The FDA currently has the authority to issue a mandatory recall when a company fails to voluntarily recall their products after notification from the FDA. Also, in attempts of controlling a food borne illness outbreaks, the FDA is in the process of establishing systems that track and trace food products in order to locate the contaminated food source in a timely manner.

The FDA is currently undergoing pilot projects in order to assess current methods and technologies for effective tracking of food products. The FDA will use the information from these pilot projects in order to set standards and requirements for all product tracking software used by industry. Quick tracking systems enable quick response times to identify the source of an outbreak and stop the spread of illness. It saves time and resources for public health officials, government agencies and food product facilities.

Preparing for the Future of Regulations of FSMA

A main component of these new regulations from the FDA will encompass data tracking, management and control mechanisms. Investing in management software that keeps sufficient monitoring of your products and provides accurate records for the FDA and state government officials is imperative for future compliance with FSMA.

You can keep up to date on future guidance documents, proposed rules and final rules concerning FSMA that are constantly updated on the FDA‰’s website. The FDA states that facilities will have one to three years after publication of final rules to implement preventative control requirements depending on the size of the business. Farmers will have two to four years to comply with produce safety requirements depending on the size of their farms and an additional two years to comply with certain water requirements.

The FDA is tackling a multitude of food safety issues with the writing and implementation of the FSMA and it will have long-lasting effects on the food industry. It is the hope that a more pro-active approach to food safety from the FDA, participating food industries and health organizations will create a more collaborative and overall safer food system. This is the time for increased awareness and participation in the new revolutionary approach to food safety.


Contributor Sara Velardi is a Ph.D. student in Environmental and Natural Resources Policy at State University of New York School of Environmental Science and Forestry (SUNY-ESF). Her research interests focus on genetically modified organisms (GMO) and food safety policy.