About the Act

The Food Safety Modernization Act (FSMA) was passed into law in 2011 to further the food safety across the food supply chain. This law is the most sweeping change to our food safety regulatory landscape in decades, and attempts to reduce the risks of foodborne illnesses by generally prioritizing effective risk prevention strategies. Congress tasked the Food and Drug Administration (FDA) in the US Department of Health and Human Services to develop and implement regulations related to FSMA. Further information about those regulations can be found below.

training & guidance on the fsma

FDA is working with public and private partners to ensure training programs meet the needs of those who must comply with the new FSMA standards, no matter their size, nature, or location. It is important to make sure that those involved in the food supply chain know what training and education resources are available and how to gain access to the trainings.

Since the FSMA was signed into law, FDA has released a series of notices and guidances related to the various rules and regulations:click here to browse all current notices and guidances. 

THE RULES & regulations of the fsma

There are seven major rules associated with the FSMA that the FDA has finalized so far: 

Click the links above to read the text of each final rule, or scroll down for a brief overview of these seven foundational rules. 

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standards for produce safety rule

The FDA Food Safety Modernization Act (FSMA) Produce Safety rule is final, and the earliest compliance dates for some larger farming operations began in January 2018. The rule establishes the country's first science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption.  Does your operation need to follow FSMA? We can help! Attend a Grower Training or contact our team for more information today!

 

preventative controls for human food rule

The FDA Food Safety Modernization Act (FSMA) Preventive Controls for Human Food rule is final, and compliance dates for some businesses begin in September 2016.  The goal of the final rule is to ensure safe manufacturing/processing, packing, and holding of food products for human consumption. Farms are largely exempt from this rule. 

 

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preventative controls for animal food rule

The FDA Food Safety Modernization Act (FSMA) Preventive Controls for Animal Food rule is now final, and compliance dates for some businesses begin in September 2016. This rule establishes Current Good Manufacturing Practices and preventive controls for food for animals.

Sanitary transportation of human & animal food

The FDA Food Safety Modernization Act (FSMA) rule on Sanitary Transportation of Human and Animal Food is now final. This rule is part of FDA’s efforts to protect foods from farm to table by keeping them safe from contamination during transportation. The goal of this rule is to prevent practices during transportation that create food safety risks, such as failure to properly refrigerate food, inadequate cleaning of vehicles between loads, and failure to properly protect food. The requirements do not apply to transportation by ship or air because of limitations in the law, but the rule does establish requirements for vehicles and transportation equipment and transportation operations.

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foreign supplier verification program rule

The FDA FSMA rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals is final, and the first compliance dates began May 30, 2017. The final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable U.S. safety standards.

mitigation strategies to protect against intentional food adulteration rule

The FDA Food Safety Modernization Act (FSMA) final rule is aimed at preventing intentional adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply. Such acts, while not likely to occur, could cause illness, death, economic disruption of the food supply absent mitigation strategies.Rather than targeting specific foods or hazards, this rule requires mitigation (risk-reducing) strategies for processes in certain registered food facilities.

ACcredited third-party certification rule

The FDA Food Safety Modernization Act (FSMA) rule on Accredited Third-Party Certification was finalized in November 2015. The rule establishes a voluntary program for the accreditation of third-party certification bodies, also known as third-party auditors, to conduct food safety audits and issue certifications of foreign entities and the foods for humans and animals they produce. These requirements are intended to help ensure the competence and independence of the accreditation bodies and third-party certification bodies participating in the program.

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This website was supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of an award totaling $424,456 with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government. For more information, please visit FDA.gov.