Overview and Background


What is the Food Safety Modernization Act (FSMA)?

The Food Safety Modernization Act (FSMA) is the first major update of federal food safety laws since 1938. FSMA gives the Food and Drug Administration (FDA) broad new powers to prevent food safety problems, detect and respond to food safety issues, and improve the safety of imported foods. FSMA does not change food safety regulations for meat, poultry, and egg products, which are under the U.S. Department of Agriculture’s jurisdiction.

FSMA authorizes new regulations at the farm level for producers and certain facilities. Specifically, FSMA mandates the establishment of:

FSMA includes key provisions to make these new regulations scale-appropriate, conservation-friendly, and accessible to certified organic producers and value-added producers. The regulations focus on addressing food safety risks from microbial pathogen contamination (e.g., Salmonella, E. coli O157:H7, and Shigella). FSMA does not address food safety risks from genetically engineered crops, pesticide use, or antibiotic resistance.

FDA has released its proposed (draft) Produce Rule and Preventive Controls Rule and is seeking public comments on both! 

Why Does it Matter?

Everyone has a role in ensuring safe food from field to fork. The Food Safety Modernization Act (FSMA) includes new regulations of practices on produce farms and in facilities that process food for people to eat. This means it represents some big changes to our food system – and it is extremely important for the Food and Drug Administration to get these regulations right so that they improve food safety without placing an unfair burden on family farms.

The risk of foodborne illness — that is, the risk of getting sick or dying from food contaminated with pathogens like E. coli — is largely preventable by good food safety measures applied at every stage of the food supply chain. Examples of good measures include hand washing and keeping foods at the right temperature. However, it’s not as simple as requiring all farms and facilities to meet identical safety requirements. Depending on the complexity of the supply chain, types of food, and practices implemented from farm to table, different kinds of farms and facilities face different types of risks when it comes to contamination that could cause illness.

With the right approach, we will be able to help ensure good food safety practices across the nation without placing an unfair burden on family farmers.

Ultimately, we want to ensure a safe food supply, strong on-farm conservation of natural resources, and thriving family farms and small value-added farm and food businesses. With regulations and requirements that are tailored to different types and sizes of operations, we can achieve these objectives.

Where Did FSMA Come From?

Due to a rise in major outbreaks of foodborne illnesses and increasing bioterrorism concerns after 9/11, both Congress and the Administration proposed new food safety measures in 2009 that expanded food safety regulations to the farm level. Previously, food safety regulatory oversight was focused mainly on the processing, food handling, and manufacturing sectors – areas shown to be of highest risk for foodborne pathogen contamination.

In 2009 and 2010, Congress debated a number of food safety proposals that directly and indirectly affected farms and on-farm processing. These proposals extended regulatory authorities to farms and made some on-farm safety standards mandatory. Concurrently, the Obama Administration created an inter-agency Food Safety Working Group through which the Food and Drug Administration and the U.S. Department of Agriculture started adopting new food safety standards and oversight.

Given the potential impacts of these new food safety proposals on sustainable food production, NSAC created a task force and engaged in the legislative debate. NSAC’s priority was to make sure that the new food safety measures worked for sustainable and organic farmers, and for consumers who wanted access to fresh, local food. Due to NSAC’s leadership and the actions of thousands of farmers and concerned consumers, the new food safety law that Congress passed and that President Obama signed – the Food Safety Modernization Act (FSMA) – included the following critical provisions:

  • Scale-appropriate regulations: Rejecting a “one-size-fits-all” approach, FSMA includes options for small, mid-sized, and direct-market agricultural operations to comply with equivalent state regulations or modified, scale-appropriate federal regulation.
  • Conservation practices: Recognizing that conservation practices have a number of public benefits, FSMA indicates that new regulations should not undermine beneficial on-farm conservation and wildlife practices.
  • Organic production: Acknowledging that organic production and food safety go hand-in-hand, FSMA specifies that new regulations must complement – not contradict – strict regulations for certified organic production.
  • Value-added processing: Supporting the development of new low-risk processing businesses, FSMA minimizes extra regulations for low-risk processing that is part of value-added production.
  • Paperwork reduction: Recognizing the burden on smaller operations, FSMA streamlines and reduces unnecessary paperwork for farmers and small processors.
  • Farm identity-preserved: Accepting that identity-preserved marketing has built-in traceability attributes, FSMA allows farm identity-preserved marketing as an option in place of government trace-back controls.
  • Training: Supporting the importance of training and capacity building, FSMA authorizes a new competitive grants program to train farmers and processors on food safety.

What Happens Next?

The Food and Drug Administration (FDA) has started the lengthy process of implementing the Food Safety Modernization Act (FSMA). FDA is currently in what is known as the rulemaking stage – meaning they are turning the bill – FSMA – passed by Congress into actual rules and regulations. They have released their proposed (draft) regulations for public comment as part of this process. These proposed regulations show FDA’s thinking on how to implement the provisions in FSMA and are not yet final. Currently, FDA is requesting comments on two proposed regulations:

  • Standards for produce production (Produce Rule), and
  • Food safety measures for facilities that process food for human consumption (Preventive Controls Rule).

After FDA has received and reviewed the comments, the agency will prepare to publish final rules (with rules as big as these, the agency might opt to release another draft set of rules before finalizing them). All of the positive provisions listed above that Congress passed as part of FSMA must make it into the final rules published by FDA to become part of the new regulations.

NSAC is carefully analyzing the proposed rules to ensure this happens, and we need your help – it is critical for sustainable farmers and consumers who care about where their food comes from to write comments to FDA about the proposed regulations to ensure that FDA correctly implements FSMA! Check out the links below to learn more about the two rules – and then submit your own comments to FDA!

Learn More about the Produce Rule

FSMA orange packing line

Learn More about the Preventive Controls Rule