In short: From 19 September 2016, larger food facilities covered by the US FDA’s Preventive Controls for Human Food rule must have a written food safety plan based on hazard analysis and risk-based preventive controls. Smaller businesses follow in later phases.
What does the rule require?
- A written food safety plan prepared or overseen by a Preventive Controls Qualified Individual (PCQI)
- Hazard analysis covering biological, chemical and physical hazards
- Preventive controls for process, allergens, sanitation and the supply chain
- Monitoring, corrective actions, verification and records
- A recall plan where needed
Who is affected first?
Businesses that do not qualify as small or very small businesses must comply first; small and very small businesses have later compliance dates.
What should exporters to the US do?
Foreign facilities registered with the FDA must also comply. Exporters should review their HACCP plans against the preventive controls requirements.
Key takeaways
- Large facilities must comply from 19 September 2016.
- A PCQI must oversee the food safety plan.
- Foreign facilities supplying the US are also covered.
Frequently asked questions
What is a PCQI?
A Preventive Controls Qualified Individual trained or experienced in developing and applying risk-based preventive controls.
Does HACCP meet FSMA?
HACCP is a strong foundation, but the preventive controls rule includes additional requirements.
Are small businesses exempt?
Small and very small businesses have later compliance dates and, in some cases, modified requirements.