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Comparative Perspective on Thermal Processing: Regulations and Practices in Mexico and the U.S.

Comparative Perspective on Thermal Processing

By Fernanda Estefanía Jiménez Garzón, EAS Consulting Group Independent Consultant

What if the foodborne illness you experienced… could have been prevented? According to the World Health Organization (2024), approximately 600 million people worldwide suffer from foodborne illnesses each year, with 420,000 fatalities attributed to the consumption of contaminated food. The primary causes of these illnesses are infections from bacteria, viruses, and parasites. Advances in scientific risk assessment, improvements in food control systems, and the application of modern thermal processing technologies have significantly enhanced the industry’s ability to prevent, detect, and respond to food safety hazards.

In countries like Mexico and the United States, regulatory frameworks have been developed to establish mandatory food safety parameters for food processing operations. In Mexico, Mexican Official Standard 130 (NOM-130-SSA1-1995) establishes the sanitary requirements and specifications for hermetically sealed foods that require heat treatment. This standard defines heat treatment as the physical method to which food is exposed by heating it to a specific heat source for a determined period, with the objective of achieving biological stability and ensuring shelf stability.

Conversely, the Code of Federal Regulations Title 21, Part 113 (21 CFR Part 113, FDA, 2023) regulates the processing of low-acid canned foods (LACF) in the United States. This regulation specifies that thermal processing consists of applying heat to food for a specific duration and at a controlled temperature, ensuring the destruction of pathogenic microorganisms. While each country maintains its own regulatory criteria, both emphasize the monitoring, control, and scientific validation of critical factors that affect food safety, particularly during thermal processing.

Equipment Requirements and Process Validation in Mexico and the U.S.

In Mexico, NOM-130 requires that thermal processing systems be equipped with monitoring and recording devices for temperature, time, and pressure to ensure effective process control. Food manufacturers should retain batch-specific process records, including thermal processing charts, for at least one year after the expiration date of the product.

In the U.S., 21 CFR Part 113 requires the use of calibrated TID (Temperature Indicating Devices) with NIST traceability, verified at least annually with an accuracy of ±0.5°C. In addition, proper placement of measuring and recording devices, automated data logging, pressure control systems and safety valves are mandatory to ensure accurate monitoring of critical control points (CCPs) during processing.

While NOM-130 does not mandate specific formats or authorities for thermal process validation, in practice, validation is supported by internal documentation and third-party or export customer audits. In contrast, U.S. regulations require all establishments to register their facilities and submit a scheduled process, which must be scientifically validated by a recognized Process Authority in accordance with FDA standards.

Hygienic Design as Preventive Control

Beyond process parameters, hygienic design plays a key role in maintaining food safety throughout the production chain. Equipment and process systems must be designed to ensure cleanability, resistance to corrosion, and the elimination of product accumulation points or dead legs. The European Hygienic Engineering & Design Group (EHEDG) provides comprehensive guidelines based on preventive design principles, including CIP (clean-in-place) compatibility, food-contact material compliance, and geometry optimization for full drainage and easy sanitation.

Finally, although Mexico and the United States differ in their regulatory structure, technical specifications and enforcement mechanisms, both share the overall objective of ensuring food safety and protecting public health. Validated and properly documented thermal processes improve traceability, reduce microbiological risks and facilitate access to high-end international markets. In today’s global food supply chain, robust thermal process controls are not only a regulatory requirement, but a strategic imperative for food manufacturers committed to safety, quality and market competitiveness.

References

Posted in Foods, Issue of the Month.