What is FSMA?
The Food Safety Modernization Act (FSMA) is applicable to food producers within and supplying the United States. It is the first major overhaul of the USA's food safety practices since 1938, and it includes new regulations for both primary producers and for facilities that process food for people to eat.
FSMA gives the USA's 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. To do so, FSMA authorizes new regulatory requirements for farmers who grow certain kinds of fresh produce, and for certain facilities that process food for people to eat.
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.
The new regulations that apply to operations that grow, harvest, pack, or hold produce is known as the Produce Safety Rule.
What is FSMA's Produce Safety Rule?
The Produce Rule establishes new standards for the growing, harvesting, packing, and holding of produce for human consumption.
FDA plans to begin routine inspections of large farms other than sprouts operations subject to the Produce Safety rule, including large produce farms in other countries, in Spring 2019.
Routine inspections of small farms (making $250,000-$500,000), other than sprouts operations, will begin in Spring 2020. However, compliance was expected starting January 2018.
Due to their unique susceptibility to contamination, the provisions covering the production of sprouts went into effect in January 2017 for farms making over $500,000. Small farms making $250,000-$500,000 will be expected to comply by January 2018, and very small farms making $25,000-$250,000 will be expected to comply by January 2019.
Key elements of the Produce Safety Rule include:
- Requirements for agricultural water quality and testing with the aim of detecting contamination by fecal matter, which may be accompanied by bacteria that cause disease.
- Requirements for the use of biological soil amendments of animal origin, including manure and compost. These requirements will help reduce the likelihood of potentially dangerous bacteria entering the food supply.
- Testing and other standards for producing sprouts to prevent contamination with dangerous microbes, such as Listeria monocytogenes.
- Methodology to identify and assess potential contamination by animals during the growing season.
- Methodology to prevent contamination of produce and food-constant surfaces by people who are sick. Includes instructing farm workers to notify their supervisors if there’s an issue with their health or hygiene that could compromise the safety of the produce.
- Standards related to equipment, tools and buildings to prevent problems, such as poor sanitation, from contaminating produce. Buildings covered by these requirements include greenhouses and germination chambers.
Does GFSI Certification Equate to FSMA Compliance, and Vice Versa?
Not necessarily; a farm that is GFSI certified cannot expect that this automatically makes it FSMA compliant, and vice versa. There are definite differences between the two, that is GFSI certified cannot expect that this automatically makes it FSMA compliant, and vice versa. There are definite differences between the two. For example, FSMA requires the existence of a Preventive Controls Qualified Individual and stipulates specific Produce Safety water requirements. None of these are mentioned by GFSI. However, being GFSI certified means you are well on your way to FSMA compliance - you just need to ensure you meet the additional FSMA-specific requirements.
