What is the Food Safety Modernization Act (FSMA) Produce Safety Rule?
The Produce Safety Rule is several sets of standards farmers must meet to minimize the risks associated with microbial contamination of produce on their farms. The primary standards focus on worker hygiene and training; soil amendments of animal origin; wild and domesticated animals; agricultural water; and sanitation related to equipment, tools, and buildings.
How do I know if my farm is fully covered and must comply with the Produce Safety Rule?
Your farm is covered if you have, on average over a three year rolling period:
When does a covered farm have to comply with the Produce Safety Rule?
Very small businesses, those with more than $25,000 but no more than $250,000 in average annual produce sales during the previous three year period: Jan. 2020
Small businesses, those with more than $250,000 but no more than $500,000 in average annual produce sales during the previous three year period: Jan. 2019
All other covered farms: Jan. 2018
The compliance dates for certain aspects of the water testing standards and related recordkeeping provisions allow an additional two years beyond each of these compliance dates.
What do I need to do as a covered farm?
At the basic level, the rule requires you to: "minimize the risk of significant adverse health consequences or death from the use of or exposure to covered produce." The standards and activities in the rule serve as a guide to accomplish this.
Where appropriate, these activities should be recorded and the logs kept for a minimum of three years in a manner which makes them available upon receipt of a 24 hour notice from a regulator. Guides and templates for required records are available. In addition to records, operations should have written standard operating procedures in place for controlling potential microbiological hazards present on the farm.
Worker Hygiene and Training
Farms are responsible for ensuring employees can safely handle produce. This includes:
Providing readily-accessible restroom facilities and handwashing stations
Providing appropriate food safety training to all employees
Preventing ill workers from touching produce or food contact surfaces
Implementing standards for employees' personal hygiene
Requiring the use of food-grade containers and equipment
Separating break areas for workers from harvesting and handling areas
Farms must also have at least one "responsible party" (owner, manager, etc.) attend an approved Produce Safety Rule grower training course.
Biological Soil Amendments of Animal Origin
Rules regarding the handling and application of biological soil amendments depend on whether the amendments have undergone an approved composting process to reduce microbial risks.
Compost application must be done at least 90 days before harvest if it has undergone a heat treatment. Winter days when the ground is frozen are not counted toward the 90 day interval. After treatment, compost must also cure for at least 45 days before application. Two examples of accepted treatment methods are:
Static composting that maintains aerobic (i.e., oxygenated) conditions at a minimum of 131 °F for 3 consecutive days; and
Turned composting that maintains aerobic conditions at a minimum of 131 °F for 15 days (which do not necessarily have to be consecutive), with a minimum of five turnings.
Raw (non-composted) manure must be applied at least 120 days before harvest. Winter days when the ground is frozen are not counted toward the 120 day interval.
Wild and Domesticated Animals
Farms are not required to exclude animals from outdoor growing areas, however, produce that has been contaminated by animal waste may not be harvested. If it is reasonably likely that wild or domesticated animals will enter crop production areas during the growing season, then the grower must determine if those areas could be contaminated. If evidence of potential contamination is found, the grower must evaluate whether the nearby produce could be safely harvested, and take measures to prevent the harvest of product that is reasonably likely to have been contaminated.
The Produce Safety Rule establishes two sets of criteria for microbial water quality. Both are based on the presence of generic E. coli, but which criteria apply depend on the relative risk of the water.
For uses where potentially dangerous microbes, if present, could be transferred to produce through direct or indirect contact, no detectable generic E. coli are allowed. If generic E. coli is detected, use of this water must be immediately discontinued and corrective actions taken before water can be used again.
For agricultural water applied directly to growing produce, there are two numerical criteria: the geometric mean (GM) and the statistical value threshold (STV). If the water does not meet these criteria, corrective actions are required as soon as practicable, but no later than the following year.
The GM is an average, and represents the central tendency of water testing results. The GM threshold of samples is 126 CFU of generic E. coli per 100 mL of water.
The STV represents the variability of water quality, which can help you understand how the levels of E. coli present in water sources can vary throughout a season.
These testing criteria are intended for use as a tool to better understand the microbial quality of agricultural water over time and help determine a long-term water management strategy. Different water sources carry different risks. As a result, the Produce Safety Rule bases testing frequency on the type of water source.
Untreated surface water: Considered the most vulnerable to external influences, farms must complete an initial survey using at least 20 samples collected as close to harvest as practicable over 2-4 years. These initial findings are used to calculate the GM and STV to create a "microbial water quality profile" for the farm. After the initial survey has been completed, five more samples will be taken and analyzed each growing season. The five new samples will be combined with the most recent 15 samples to create a rolling set of 20 samples which can be used to annually recalculate the GM and STV.
Untreated ground water:
When used for irrigation, farms must create a "microbial water quality profile" using at least 4 samples taken and analyzed as close as is practicable to harvest over one growing season. These findings are used to calculate the GM and STV. After the initial profile, one sample must be taken annually to confirm the water still meets the appropriate criteria.
When used for post-harvest purposes, farms must create a "microbial water quality profile" to determine if the water can be used. If no generic E. coli is detected, only one sample per growing season is required. Farms must resume testing at least four times per year if an annual test detects generic E. coli.
Public Water Systems: There are no requirements to test agricultural water sourced from a public water system. You just need to have the test results available from the public municipality.
Equipment, Tools, and Buildings
The rule establishes standards related to equipment, tools and buildings to prevent these sources, and inadequate sanitation, from contaminating produce. Required measures to prevent contamination of covered produce and food contact surfaces include:
The use of food-grade containers
Proper cleaning and sanitizing of food contact surfaces
Providing readily-accessible restroom facilities and handwashing stations