Sterilex and FSMA Compliance

sterilex_fsma-1-copyAs of September 2016, the Food Safety Modernization Act (FSMA), is in full effect. For food manufacturers, the requirements to meet new standards compliance are significant. One of the key components for compliance with the law 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 management of the preventative control protocols that have been created [1].

Implementation of preventive controls begins with determining what potential hazards exist in the processing environment, or are actually created by the process. The FDA draws no distinction between hazards that are introduced intentionally and those that are naturally occurring. For example, Listeria monocytogenes contamination due to the natural soil residue on incoming produce would 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 understand where hazards may exist, they must create a written food safety plan for addressing the hazards [2]. That plan must then be updated and managed as new hazards are presented or when 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 determining the proper controls to put in place, manufacturers must identify adequate chemical interventions to address hazards in the processing environment. These chemical interventions must be validated with “scientific evidence” to ensure that the control can mitigate the hazard.  Sterilex offers a line of products based on its proprietary PerQuat® Technology, the only chemistry with products approved to remove biofilm in public health applications.*  Biofilms, which are considered a microbial hazard and must be controlled in processing environments, are found in microbial harborage niches on equipment or in the environment*. EPA registered sanitizers such as Sterilex® Ultra Disinfectant Cleaner Solution 1 or Sterilex® Ultra Step, go through exhaustive testing that meets the demand for “scientific evidence” of the capability to kill organisms such as Listeria, Salmonella, and E. coli on a variety of food contact and environmental surfaces. Unlike unregistered floor “treatments”, as an EPA registered floor sanitizer, Sterilex Ultra Step is legally approved to be included in the processor’s food safety plan for microbial control on floors and in floor mats. Sterilex products deliver the solutions that today’s sanitation experts and processors seek to meet the preventative control requirements of FSMA.

  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/

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