Part 117 Calculator

Determine if your food business is subject to FDA's Preventive Controls for Human Food rule (21 CFR Part 117)

Evaluate Your Business

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Total sales of food (adjusted for inflation)
Include all employees across all business locations

Compliance Assessment

Compliance Status

Subject to Part 117? --
Qualified Facility? --
Compliance Date: --
Applicable Subparts: --

Requirements

Requirement Status Notes

Potential Exemptions

Exemption Applies? Details
Important Disclaimer

This calculator provides general guidance only and does not constitute legal advice. Regulations change over time, and specific circumstances may affect your compliance requirements. We recommend consulting with a food safety professional or legal expert for a definitive assessment.

Part 117 Overview

Key Subparts of 21 CFR Part 117

Subpart Description
Subpart A General Provisions (definitions, exemptions)
Subpart B Current Good Manufacturing Practice (CGMP)
Subpart C Hazard Analysis and Risk-Based Preventive Controls
Subpart D Modified Requirements (for qualified facilities)
Subpart E Withdrawal of Qualified Facility Exemption
Subpart F Requirements for Records
Subpart G Supply-Chain Program

Qualified Facility Status

A "qualified facility" is a facility that is either:

  1. A "very small business" (averaging less than $1,000,000 per year in sales of human food plus market value of food manufactured, processed, packed, or held without sale), OR
  2. A facility where:
    • The majority of the food sold was sold directly to "qualified end-users" (consumers or local restaurants/retail food establishments), AND
    • The average annual value of food sold directly to qualified end-users exceeded the average annual value of food sold to all other buyers during the 3-year period preceding the applicable calendar year.
Compliance Dates

Compliance dates for Part 117 vary based on business size:

  • Small Business (fewer than 500 full-time equivalent employees): September 18, 2017
  • Very Small Business (averaging less than $1,000,000 per year in sales): September 17, 2018
  • Other Businesses: September 19, 2016

Understanding FDA's Part 117 Requirements

The FDA Food Safety Modernization Act (FSMA) Part 117 represents a significant shift from responding to foodborne illness to preventing it. Understanding these regulations is crucial for food businesses to ensure compliance and maintain food safety.

Core Requirements

  • Food Safety Plan: Written plan developed by a preventive controls qualified individual (PCQI)
  • Hazard Analysis: Identify and evaluate known or reasonably foreseeable hazards
  • Preventive Controls: Measures to ensure hazards are minimized or prevented
  • Monitoring Procedures: Ensure preventive controls are consistently performed
  • Corrective Actions: Procedures to address deviations from preventive controls
  • Verification: Ensure preventive controls are consistently implemented and effective
  • Record-Keeping: Documentation of monitoring, corrective actions, and verification
  • Supply-Chain Program: Ensure control of hazards in raw materials and ingredients
  • Recall Plan: Written procedures for product recalls

Common Exemptions

  • Qualified Facilities: Subject to modified requirements
  • Certain Farm Activities: Covered under the Produce Safety Rule instead
  • Seafood HACCP: Facilities already complying with seafood HACCP regulations
  • Juice HACCP: Facilities already complying with juice HACCP regulations
  • Dietary Supplements: Facilities in compliance with dietary supplement GMPs
  • Alcoholic Beverages: Under certain conditions
  • Low-Risk Activities: Certain on-farm low-risk manufacturing/processing activities

Preventive Controls Qualified Individual (PCQI)

A PCQI is someone who has successfully completed training in the development and application of risk-based preventive controls or is otherwise qualified through job experience to develop and apply a food safety system.

Key responsibilities include:

  • Preparing the food safety plan
  • Validating preventive controls
  • Reviewing records
  • Reanalyzing the food safety plan

Modified Requirements for Qualified Facilities

Qualified facilities are subject to modified requirements, which include:

  • Submitting attestations to FDA regarding:
    • Qualifying for the exemption
    • Either implementing preventive controls and monitoring, OR
    • Compliance with applicable non-federal food safety laws
  • Maintaining records to support attestations
  • Still subject to CGMPs (Subpart B)

Implementation Steps

Step 1: Determine Applicability

Determine if your facility is subject to Part 117 and which requirements apply. Assess if you qualify for any exemptions or modified requirements based on facility size, types of activities, and products.

Step 2: Develop Food Safety Plan

Have a PCQI develop a written food safety plan that includes hazard analysis, preventive controls, monitoring procedures, corrective action procedures, verification procedures, and a recall plan.

Step 3: Implement and Monitor

Implement the food safety plan, conduct monitoring activities, take corrective actions when needed, conduct verification activities, and maintain required records to document compliance.

Resources for Compliance