The FDA Food Safety Modernization Act (FSMA) was signed into law in 2011. It aims to ensure the U.S. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it and represents a significant revamp of food safety rules in decades.
Below are the key requirements of the Produce Safety rule for the growers and the Preventive Controls rule for handlers. The California Walnut Commission and Board will be partnering with DFA of California to offer regional in-depth FSMA trainings, so stay tuned.
PRODUCE SAFETY
Agricultural Water
Water Quality: No detectable generic E. coli are allowed for certain uses of agricultural water (hand washing, produce contact surface, for example). Secondly, geometric mean (GM) and the statistical threshold (STV) to be used as numeric criteria rather than a single test. The GM of samples is 126 or less CFU of generic E.coli per 100 mL of water and the STV of samples is 410 CFU or less of generic E.coli in 100 mL of water.
Water Testing
Untreated Surface Water: 20 samples in the first 2-4 years to establish a baseline; 5 samples every year thereafter.
Untreated Ground Water: 4 samples in the first year to establish a baseline; minimum 1 sample every year thereafter.
Compost or Organic Soil Amendments
The FDA had deferred to the National Organic Program (NOP) rules for using raw manure or compost. Raw manure will follow a 90 or 120 day pre-harvest interval depending on whether the manure comes in contact with the produce or not. Certified compost does not have a pre-harvest interval.
Domesticated and Wild Animals
FDA notes that growers should take reasonable care to avoid intrusion of domestic and/or wild animals during harvest. However, arms are not required to exclude animals from outdoor growing areas, destroy animal habitat, or clear borders around growing or drainage areas. Nothing in the rule should be interpreted as requiring or encouraging such actions.
Worker Training and Health and Hygiene
Farm workers who handle produce and/or food-contact surfaces, and their supervisors, must be trained on certain topics, including the importance of health and hygiene.
COMPLIANCE DATES
- 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 : four years
- 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: three years
- All other farms: two years
- The compliance dates for water quality standards allow an additional two years beyond each of these compliance dates for the rest of the final rule.
PREVENTIVE CONTROLS
Hazard Analysis
The rules require a written food safety plan that is based on hazard analysis (physical, chemical, biological and radiological) at key operational steps.
Preventive Controls
These measures are required to ensure that hazards requiring a preventive control will be minimized or prevented. They include process, food allergen, and sanitation controls, as well as supply-chain controls and a recall plan.
Management of Preventive Controls
For an effective implementation of preventive controls, monitoring, record keeping, corrective actions and verification are key steps. Product and/or environmental monitoring generally would be required if contamination of a ready-to-eat food with an environmental pathogen is a hazard requiring a preventive control.
‘Farm’ Definition
FDA has clarified the definition of ‘farm’ to cover ‘Primary Production Farm’ i.e. a typical growing operation, and ‘Secondary Activities Farm’, which may be located further away from the main farm. Examples of secondary farm include off-farm warehouse or holding area or hulling and dehydrating. The caveat being the primary farm must be a majority owner in the off-farm activities.
NOTE: Commercial huller/dehydrators do not meet the definition of Secondary Activities Farm and will fall under Preventive Controls rule.
Training
Management is required to ensure that all employees who manufacture, process, pack or hold food are qualified to perform their assigned duties. Such employees must have the necessary combination of education, training, and/or experience necessary to manufacture, process, pack, or hold clean and safe food. Individuals must receive training in the principles of food hygiene and food safety, including the importance of employee health and hygiene.
COMPLIANCE DATES
Compliance dates for businesses are staggered over several years after publication of the final rule.
- Very Small Businesses (averaging less than $1 million per year (adjusted for inflation) in both annual sales of human food plus the market value of human food manufactured, processed, packed, or held without sale): Three years, except for records to support its status as a very small business (January 1, 2016).
- Small Businesses (a business with fewer than 500 full-time equivalent employees): Two years
- All other businesses: One year
(Reference: FDA)