The Food Safety Modernization Act (FSMA) signed by President Obama in 2011 represents the largest regulatory change in the USA since 1938 in the agri-food sector. Before FSMA, authorities and companies acted after outbreaks. The main aim of FSMA is to prevent outbreaks. It is especially designed to prevent microbiological contamination of products consumed in the USA.

This modernization deals with products regulated by the Food & Drug Administration (FDA). It results in a significant strengthening of the requirements on imports.

From September 16, 2016, every company producing food in the USA or each company aiming at exporting food products to the US will have to implement a Food Safety Plan, established by a Preventive Controls Qualified Individual (PCQI).

More generally, food companies will have to “evaluate the hazards in the operations, implement and monitor effective measures to prevent contamination and have a plan in place to take any corrective actions that are necessary”3

Focus on Prevention

Most of the food safety system in the USA is currently based on the sampling approach. Once a lot is produced or a raw batch of products is received, it is tested to check its non-pathogenicity. Unfortunately, the sampling method is fallible since only a portion of the production is analyzed. This is why so many foodborne outbreaks happen. The idea is to minimize foodborne illnesses by focusing on prevention. It is not new, the FDA and the USDA have already implemented stricter regulatory requirements for several products like eggs, juice and meat4. The goal is to use those methods for every products sold in the country, intended to people or animals.

One major change for companies exporting to the US is that they will have to prove the safety of their food, under penalty of having their imported merchandises blocked at the border. American companies will also need to verify that their suppliers comply with FMSA requirements.

These preventive measures (non-exhaustive) will ensure a notable reduction of food borne illnesses. A key idea that arises from FMSA regulation is Risk-Based Preventive Controls & Validation of Preventive Controls.

Process Validation & Verification

These food safety components are key aspects of Food Safety. From now on, the FDA focuses more on preventive controls to minimize foodborne outbreaks. Process validation and process verification are the tools to achieve this goal. Nevertheless, there is a clear difference between validation and verification, which is often misunderstood.

Process validation is the first step to take when installing new equipment, creating new products or seeking to understand the lethality of existing equipment. It is the action to scientifically give the evidence that an industrial process has a constant effect of pathogenic destruction. The evidence can be supported by documentation5, mathematical modeling, risk assessment and evaluating preventive controls using surrogate microorganisms. The main idea is to validate the kill-step used for production, i.e. the oven, extruder, frying system etc. In other words, validating that this particular industrial process is capable of systematically eliminating a predefined ratio of undesired pathogenic microorganisms: it is called ‘the log reduction’6.
Following data analysis, a validation report needs to be prepared.

As far as verification process is concerned, it is in fact the continuity of the process validation. Once the process is validated, verification ensures that the food safety plan is functioning as written and that it is effective. Verification activities, which ensure that preventive controls are consistently implemented and followed, should include confirmation that the preventive controls are adequate for their purpose and are controlling the hazard. Confirmation activities include measures that verify that controls are operating as intended and that reviews of monitoring records have occurred7.

1 Who; Who estimates of the global burden of foodborne diseases; p.10: http://apps.who.int/iris/bitstream/10665/199350/1/9789241565165_eng.pdf?ua=1
5 Validation and Verification of Food Safety Control Measures: http://www.qualityassurancemag.com/article/aib0615-food-safety-validation-verification-methods/
7 Validation and Verification: A Practical, Industry-driven Framework Developed to Support the Requirements of the Food Safety Modernization Act (FSMA) of 2011, Food Protection Trends, Nov/Dec 2014

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