IS ENVIRONMENTAL MONITORING REQUIRED FOR EVERY PLANT?
The process of producing high quality, safe food demands more precise attention to a clean environment than any other industry. Every consumer trusts and relies on the food producers to follow all guidelines for clean and safe food every step of the way–from the farm to the table. However, the food industry environmental standards can be difficult to maneuver, as we each focus on our area of expertise—whether that be agriculture, manufacturing, distribution, packing, or direct food service to the consumer. There has been confusion on the requirements for environmental monitoring programs, the degree to which it is implemented, and the methodology in how the implementation is approached.
These factors can be challenging for quality professionals who often must provide clear supporting documentation to senior management that outlines the requirements for programs with seemingly ambiguous requirements that also come with implementation as well as ongoing costs. So often the primary question is how do we demonstrate, not only to organizational leadership, but also to regulatory oversight bodies, GFSI certification bodies, and customers that we are meeting the burden of proof when it comes to environmental monitoring programs?
In short, while most regulatory bodies and no GFSI certification schemes explicitly require environmental monitoring as a default requirement — they all require a risk-based assessment on the products produced, the conditions under which they are produced, the intended use, and the environmental exposure at each processing step. The results of this scientifically data-driven risk assessment shall determine the requirements for environmental monitoring program implementation and the robustness of the overall program. The burden of proof lies on the producer in determining this outcome and the approach to assessment, implementation, and robustness must employ scientific methodology, supporting data, and supporting documentation including peer-reviewed literature, government and regulatory body guidance documentation.
BACKGROUND ON REGULATORY LANDSCAPE AND REQUIREMENTS FOR ENVIRONMENTAL MONITORING:
With the advent of FSMA and Preventive Controls in conjunction with already established USDA-FSIS requirements (Listeria Final Rule) and guidances, the groundwork for requiring environmental monitoring programs is largely in place. FSMA takes the position of risk assessments, like GFSI schemes largely do, and they put the burden of proof on the manufacturer to demonstrate any scientifically valid “proof” for the absence of such programs.
BACKGROUND ON GFSI REQUIREMENTS FOR ENVIRONMENTAL MONITORING:
GFSI schemes have historically been largely non-prescriptive in regards to environmental monitoring programs focusing almost entirely on doing “risk assessments” for the products and processes however this is evolving with the release of BRC Edition 8, SQF Edition 8 and FSSC 22000 4.1. All schemes are working towards FSMA and preventative controls alignment and have made significant strides in this regard. Whether it is specifying high hygiene zones, high risk product categories, or foods handled post- lethality treatment the standards are dialing in on requiring environmental monitoring programs outright. Even low risk foods will be subject to auditors’ scrutiny in the absence of appropriate and reasonable EMPs.
HOW TO MOVE FORWARD WITH RISK ASSESSMENTS AND IMPLEMENTATION:
In order to effectively assess and map out the implementation or enhancement of environmental program one must simply start with getting the data. While much literature and knowledge exists around product risk categorization as well as around manufacturing process and sanitary design of equipment, relying on supporting documentation alone may not be enough. A structured, mapped, scientifically designed study to assess microbial loads and associated risks, under the guidance of a Subject Matter Expert, should be considered in many cases. The use of indicator organism swabbing in conjunction with pathogen swabbing can greatly enhance the quality of the study as it enables better resolution into microbiological conditions of the environment.
Once we have the data taken from pre-operational conditions, operational, and outer zones we can map out geographically the potential ingress points, sanitation practices and efficacies, wet and dry cleaning methods, extended run impacts, equipment and operational impacts. The more robust the study design (sample size, locations, and operational timing) the greater a base for knowledge a risk assessment can be achieved. Thought must be given at all times however to not asking for data one is not ready to respond to. If the organizations CAPAs routines, documentation, and mitigation methods are not established those must be put in place to manage against any potential positives.
At this point the implementation of new environmental monitoring programs or enhancement of existing programs can be undertaken now that we know where and when attention should be focused. It is critical to understand the expectations and standards of environmental regulations, as well as comprehend the collected data and be proactive in developing a plan of how to use the data to promote safety.