FSMA Requirements

FSMA, or the Food Safety Modernization Act, is a set of regulations implemented by the United States Food and Drug Administration (FDA) in 2011 to ensure the safety of the food supply. The requirements of FSMA apply to most entities that produce, transport, distribute, and sell food products in the United States. Learn more about who is subject to the law

Planning

What is new and unique about the Preventive Controls Rule is that it focuses on preventing food safety incidents instead of reacting to them after they happen. It requires a food safety plan that includes preventive controls in addition to the process controls you will find in traditional HACCP plans. A preventive controls Food Safety Plan includes:

• An evaluation of potential food safety hazards
• Steps and controls to prevent those hazards
• A system to monitor the controls
• Routine records of the monitoring
• A recall plan

The Food Safety Plan must include:

Hazard analysis

Identify any known or reasonably foreseeable biological, chemical, and physical hazard and determine if any of those hazards require a preventive control and must consider:

• The formulation of the food;
• The condition, function, and design of the facility and equipment;
• Raw materials and other ingredients;
• Transportation practices;
• Manufacturing/processing procedures;
• Packaging activities and labeling activities;
• Storage and distribution;
• Intended or reasonably foreseeable use;
• Sanitation, including employee hygiene; and
• Any other relevant factors, such as the temporal (e.g., weather-related) nature of some hazards (e.g., levels of some natural toxins).
• Facility and product/process specific

Preventive controls

If the hazard analysis identified a hazard requiring a preventive control, you must implement risk-based measures to significantly minimize or prevent food safety hazards

Types of Preventive Controls:

• • Process Controls (equivalent to CCPs)
  • Allergen Controls (human food only)
  • Sanitation Controls
  • Supply Chain Controls
  • others

Risk-based supply chain program

If you identify any hazards related to ingredients purchased from your supplier and if you depend on the supplier to control that hazard, you must have a supply-chain control program with verification activities.

• • Evaluate suppliers for approval
  • Establish written procedures for receiving and use of approved suppliers
  • Conduct appropriate supplier verification activities

A recall plan

Written recall plan including the procedures detailing steps you will take to perform a recall and assigning responsibility for performing them. You will need this if your hazard analysis identifies a hazard requiring a preventive control.

Record keeping

• The Food Safety Plan must be signed by the owner, operator, or agent in charge, upon completion and after any modification
• Records related to the Food Safety Plan
  • must be accurate, indelible, and legible
  • must be signed, dated, and properly identified
  • must be kept for at least 2 years
  • subject to FDA review

What if we already have a HACCP plan?

That is a great start. Here are some of the things you will need to add to it:

Taken from “Hazard Analysis and Risk-based Preventive Controls for Human Food: Draft Guidance for Industry”