Preventive Controls for Human Food

Preventive Controls for Human Foods (PCHF): The Preventive Controls for Human Foods (PCHF) is one of the seven major rules of FSMA and likely the most impactful for the spice industry.

This rule represents a major shift in moving towards a preventative food safety system. Preventive controls are steps that a domestic or foreign food facility must take to reduce or eliminate identified food safety hazards (including biological hazards such as Salmonella, physical hazards such as metal, and chemical hazards such as pesticides). The PCHF rule requires all food facilities have a food safety plan in place that includes an analysis of hazards and risk-based preventive controls to minimize or prevent the identified hazards.

Under PCHF, a food safety plan requires a hazard analysis, validated preventive controls, allergen controls and sanitation controls. Compliance also requires a supply chain program and a recall plan. The rule also establishes requirements for verification, monitoring and developing corrective actions. FDA has provided additional resources and guidance for industry available here.

This rule also updated the current Good Manufacturing Practices (cGMPs) requirements. The PCHF retained existing cGMPs related to the personnel, plant and grounds, sanitary operations, sanitary facility control, equipment and utensils, processes and controls, warehousing and distribution, and defect action levels. PCHF also established new requirements pertaining to training requirements, allergen cross-contact controls, and human food byproducts used for animal food.

Guidance

ASTA has developed the following resources to support industry compliance for PCHF:
Webinar on FSMA Webinar on the Preventive Controls for Human Food Final Rule
ASTA Risk Assessment Guidance
Validation Resources
ASTA HAACP Guidance
ASTA cGMP Guidance
Ready to Eat FAQ

Key FDA References & Resources:
FDA Webpage on Preventive Controls for Human Food
Final Rule on Preventive Controls for Human Food
Code of Federal Regulations Chapter 21 Section 117
Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food

Food Facility Registration

FDA inspects both domestic and international facilities that are required to register as food facilities. FSMA requires re-registration of covered food facilities, which are required to register with the FDA biannually in even numbered years. Under FSMA, facilities must also submit additional registration information to FDA, including an assurance that FDA will be permitted to inspect the facility. Additionally, the registration gives the FDA authority to suspend the registration of a food facility in certain circumstances.

Inspection and Compliance

The following documents are tools that companies may find helpful in preparing a facility to comply with the PCHF rule and therefore a FSMA inspection.

Appendix 1 to the PCHF Guidance includes potential hazards for foods and processes, including potential biological, chemical, and physical hazards. Appendix 1 is NOT a checklist for inspections, but is intended to provide guidance on the type of information that FDA inspectors are looking to see in a food safety plan that will be scrutinized during an inspection.

FDA Investigations Operations Manual (IOM) provides information for what an FDA inspection can entail, and provides information on what processes and information an FDA inspector uses. The IOM also includes information on inspection policies on sampling, photography, imports, and more.