Sterilex and FSMA Compliance

As of Sept 2016, FSMA, the Food Safety Modernization Act is in full effect. For food manufacturers, the implications of reaching compliance, are immense. One of the key components of compliance is the requirement for preventative controls. Although this is a broad topic, it can be summarized in three sections, Hazard Analysis, development of preventative controls, and finally management of the preventative control protocols that have been created [1].

The process of implementing preventative controls begins with determining what potential hazards exist in the processing environment, or are created by the actual process. The FDA draws no distinction between hazards that are introduced intentionally and those that are naturally occurring. For example, Listeria contamination due to the natural soil residue on incoming produce would still be considered a hazard that must be noted and addressed. From a sanitation perspective, limiting pathogen movement and recognizing pathogen harborage points in the processing environment are essential.

After processors know where hazards exist, they must create a written food safety plan for addressing all the hazards [2]. That plan, must then be managed as new hazards are presented, or the process changes. A critical part of the creation and implementation of preventative controls is verification. This includes, “Validating with scientific evidence that a preventive control is capable of effectively controlling an identified hazard.” [1].

In identifying the proper controls to put in place, manufacturers must identify adequate chemical interventions to address hazards in the processing environment. Sterilex offers a full line of EPA registered sanitizers and disinfectants that are proven to be effective in removing biofilms, which are a hazard created by harborage points on equipment or in the environment. EPA registered sanitizers such as Sterilex Ultra Step, go through exhaustive testing that meets the demand for “scientific evidence” of the capability to control organisms such as Listeria, Salmonella, and E. coli. As an EPA registered sanitizer Ultra Step is legally approved to be included in the processor’s food safety plan. As processors and sanitation experts collaborate to meet the preventative control requirements of FSMA, the Sterilex product line provides much needed solutions.

  1. https://www.fda.gov/food/guidanceregulation/fsma/ucm334115.htm
  2. http://www.foodsafetymagazine.com/magazine-archive1/octobernovember-2015/hazard-analysis-and-risk-based-preventive-controls-harpc-the-new-gmp-for-food-manufacturing/
About Sterilex

*Biofilm label claims approved for specific applications only. See product label for full label claims and usage instructions.
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