Not Heat Treated – Shelf Stable HACCP Process Category

Aligned with USDA-FSIS HACCP Requirements – 9 CFR Part 417

Requirement Overview

The HACCP Not Heat Treated – Shelf Stable Process Category applies to establishments producing shelf-stable products that do not undergo thermal processing, such as cured meats, jerky, dry sausages, or fermented products. Under 9 CFR Part 417, establishments must conduct hazard analyses and implement CCPs to prevent microbial growth and chemical hazards, ensuring product safety without relying on heat treatment.

Non-heat-treated shelf-stable products are vulnerable to pathogens like Staphylococcus aureus, Clostridium botulinum, and spoilage organisms. Proper formulation, water activity control, and packaging are critical for ensuring safety.

Disclaimer: This content is for educational and compliance support purposes only and is not affiliated with or endorsed by USDA or FSIS. For official guidance, refer to the USDA FSIS website.

Key Compliance Objectives

  • ✓ Identify hazards specific to non-heat-treated shelf-stable products (pathogens, spoilage, chemical residues)
  • ✓ Validate water activity, pH, and preservative controls as CCPs
  • ✓ Implement monitoring for environmental and product parameters
  • ✓ Maintain thorough documentation for regulatory and third-party audits

Step-by-Step Compliance Implementation

1. Develop Shelf-Stable HACCP Strategy

  • Core Hazard Areas:
  • • Pathogen survival in reduced-moisture or fermented products (e.g., Clostridium botulinum, Staphylococcus aureus)
  • • Product spoilage resulting from moisture migration or pH fluctuations
  • • Contamination introduced through packaging materials, handling, or environmental exposure
  • Intervention Examples:
  • • Control water activity (aw) below established critical limits to prevent pathogen growth
  • • Use approved preservatives and curing agents in compliance with regulatory requirements
  • • Monitor pH throughout fermentation or curing to ensure proper microbial inhibition
  • • Maintain packaging integrity and environmental controls to prevent contamination and rehydration
  • Evidence to Maintain:
  • • Hazard analysis files and documented CCP determination for shelf-stable and cured products
  • • Process flow diagrams covering production, curing, fermentation, and packaging stages
  • • Water activity and pH monitoring records, including calibration and verification documentation

  • Testing Frequency by Risk Level:

Risk Level Verification Method Recommended Frequency
High (e.g., peanut lines) ELISA + ATP testing After every cleaning cycle
Medium (shared lines) Visual + ATP Weekly
Low (dedicated equipment) Visual inspection only Monthly

  • Intervention Examples:
  • • Steam vacuum applications for localized removal of visible contamination on carcass surfaces
  • • Organic acid sprays (e.g., lactic or acetic acid) applied to reduce microbial load post-dressing
  • • Hot water pasteurization cabinets for whole-carcass thermal intervention prior to chilling

  • Evidence to Maintain:
  • • Hazard analysis documents detailing biological, chemical, and physical risks by product and process
  • • Process flow diagrams and decision trees showing CCP identification and control logic
  • • Scientific, regulatory, and industry supporting documents for intervention effectiveness and CCP selection

2. Validate Shelf-Stable CCPs

  • Validation Protocol Should Include:
  • • Verification of water activity (aw), pH, and preservative concentrations against critical limits
  • • Testing using worst-case product formulations, batch sizes, and environmental conditions
  • • Microbial challenge studies or literature-supported validations demonstrating control of target pathogens
  • • Calibration of instruments used to monitor aw, pH, temperature, and other critical parameters
  • Evidence to Maintain:
  • • Validation reports, microbial challenge data, and supporting scientific references
  • • CCP monitoring records documenting ongoing compliance with aw, pH, and preservative limits
  • • Calibration certificates for all monitoring and verification equipment
  • • Corrective action documentation, including investigation, resolution, and preventive measures

3. Implement Routine Monitoring

  • Monitoring Program Components:
  • • Routine measurement of water activity (aw) and pH during production and storage
  • • Verification that preservative levels are correctly added and within established limits
  • • Inspection of packaging integrity and environmental conditions to prevent contamination or moisture uptake
  • • Documentation of deviations and implementation of corrective actions when critical limits are exceeded
  • Evidence to Maintain:
  • • Monitoring logs with batch identifiers, operator names, and recorded results
  • • Corrective action documentation including cause, response, and verification of effectiveness
  • • Trend reports for recurring deviations or fluctuations in aw, pH, or preservative performance

4. Monitor, Analyze & Improve

  • Data Management Best Practices:
  • • Conduct trend analysis of water activity, pH measurements, and microbial test results to identify patterns and risk areas
  • • Review CCP monitoring performance and corrective actions on a scheduled basis to verify ongoing process control
  • • Reassess HACCP plan annually or whenever product formulations, equipment, or processing conditions change
  • Evidence to Maintain:
  • • Monthly trend and deviation reports for aw, pH, preservatives, and microbial performance
  • • Root cause investigation documentation for non-conformances and implemented preventive measures
  • • Updated SOPs, competency records, and staff training documentation

Common Audit Findings & Recommended Fixes

Audit Finding Recommended Solution
No validation for water activity or pH control Perform in-plant testing or reference validated studies
Inconsistent preservative addition Implement standardized addition logs and batch checks
Missing environmental or packaging checks Establish inspection schedules and monitoring logs
No microbial verification Include routine challenge studies or swab testing
Outdated hazard analysis Update annually or after formulation/process changes

Auditor Verification Checklist

  • Auditors will expect to review:
  • • Hazard analysis and CCP determination specific to non-heat-treated shelf-stable products
  • • Validation studies supporting water activity (aw), pH, and preservative controls, including scientific references or challenge data
  • • CCP monitoring logs and deviation records demonstrating compliance and process control
  • • Corrective action documentation detailing investigation, resolution, and preventive measures
  • • Process flow diagrams and batch records covering curing, fermentation, storage, and packaging

Implementation Roadmap

Build Your Program

  • ✓ Identify hazards and determine CCPs for shelf-stable products
  • ✓ Map process flow diagrams for curing, fermentation, or packaging operations
  • ✓ Develop monitoring and corrective action procedures

Train and Validate

  • ✓ Train staff on monitoring water activity, pH, and preservative addition
  • ✓ Validate worst-case product formulations and batch conditions
  • ✓ Verify calibration and competency of monitoring equipment

Operate and Monitor

  • ✓ Conduct routine CCP monitoring
  • ✓ Track deviations and corrective actions
  • ✓ Maintain environmental and batch records

Improve Continuously

  • ✓ Perform annual HACCP reassessment
  • ✓ Revalidate CCPs after formulation or process changes
  • ✓ Conduct monthly trend analysis

Why This Matters?

Effective HACCP for non-heat-treated shelf-stable products:

  • ✓ Ensures products remain safe without thermal processing
  • ✓ Prevents pathogen growth and spoilage
  • ✓ Demonstrates compliance with FSIS regulations
  • ✓ Protects consumer health and brand reputation
  • ✓ Strengthens audit readiness and due diligence

Not Heat Treated – Shelf Stable HACCP Services & Pricing

HACCP Service Description Price Action
Shelf-Stable HACCP Assessment Hazard analysis for non-heat-treated shelf-stable foods including CCP identification, ingredient hazard review, and process flow mapping for dehydrated, fermented, cured, or acidified products in alignment with Codex and U.S. regulatory expectations. $599 / session Get Started
aw & pH Validation Validation of water activity (aw), acidity levels, and preservative parameters to prevent pathogen survival and toxin formation. Includes instrument calibration benchmarking, challenge study review, and regulatory reference thresholds. $899 / project Get Started
CCP Monitoring Setup Development of monitoring logs for aw, pH, preservative concentrations, packaging integrity, and ingredient controls including calibration intervals, acceptance criteria, verification signatures, and decision-tree outputs. $499 / module Get Started
Corrective Action Program Root-cause analysis and deviation management for failures in aw testing, pH control, preservative dosing, packaging breach, or ingredient non-conformance, including isolation protocols and documentation for traceability and regulatory audits. $699 / project Get Started
Verification & Review Periodic assessment of monitoring performance, calibration records, trend reviews of aw / pH results, validation study updates, and readiness for regulatory inspection or third-party certification audits. $999 / site / month Get Started
HACCP Toolkit Shelf-stable focused documentation package including process flow diagrams, CCP monitoring logs, validation sheets for aw and pH, corrective action forms, verification checklists, and audit-ready reference templates. $1,299 one-time Get Started
Implementation Support On-site or virtual guidance to implement shelf-stable HACCP controls, configure monitoring systems, train staff, and align documentation with FSIS, FDA, or GFSI expectations for aw and pH-regulated products. $699 / project Get Started

Need Help Developing or Validating Your Non-Heat-Treated Shelf-Stable HACCP Program?

Consultare Inc. Group provides:

  • ✓ Shelf-stable product HACCP plan development
  • ✓ CCP validation and intervention support
  • ✓ Monitoring and sanitation training materials
  • ✓ Audit preparation and documentation templates

GET STARTED NOW

This document is for internal training and compliance use only and is not affiliated with USDA or FSIS.

Please refer to official USDA FSIS guidelines for regulatory requirements.