FSMA and the role of environmental monitoring

Signed into law more than five years ago, The FDA Food Safety Modernization Act (FSMA) is now finalized and will take effect over the next few years. The most comprehensive reform of our food safety laws in more than 70 years, FSMA aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination, to preventing it in the first place.

To help accomplish this, one major component of FSMA is environmental monitoring. As a whole, environmental monitoring is directed at microbiological hazards and essentially proves that a facility is successfully verifying that its preventive controls are consistently implemented and are effectively working to significantly minimize or prevent previously defined hazard(s) from occurring.

An environmental monitoring program contains several aspects including sanitation monitoring as well as monitoring for pathogens or any other form of contamination or recontamination that could occur in a food production facility. Environmental monitoring is specifically mentioned under 117.165: Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food, and requires a facility to conduct validation and verification activities, as appropriate to the nature of the preventive controls to ensure a clean facility.

These validation and verification efforts are based on hazard analysis, written food safety plan, SSOPs, etc. and show that efforts to limit microbiological hazards are in fact working. Because of the variation in facilities, processes, and products produced, the specifics of the procedures needed to ensure a clean facility are very different from one facility to another. That is why the FDA does not define specific factors associated with developing an environmental monitoring program. Instead, it is stated that they are required to “be adequate for their intended purpose.”

Although environmental monitoring is listed as a possible verification activity, it is only required as appropriate to the food, facility, the nature of the preventive control, and the preventive control’s role in the facility’s food safety program. For example, in facilities that are producing ready-to-eat (RTE) items, their environmental monitoring program will be much different from one that involves foods that will be cooked or further processed before being consumed.

That being said, such methods of validation and verification could include sanitation monitoring, which tests surfaces after sanitation efforts have been complete for adenosine triphosphate (ATP). ATP is a molecule found in all living cells; thus, in and of itself, ATP is not a hazardous contaminant. However, detection of its presence after equipment has been cleaned is an indicator that food, bacteria, or other organisms have been left behind and shows that the cleaning process was not sufficient.

ATP hygiene monitoring systems have become a standard in measuring the effectiveness of cleaning efforts in the food production industry. ATP testing aligns with FSMA’s environmental monitoring rules as a form of verification and validation and could be adapted into a production facility’s sanitation standard operating procedures (SSOP) as well.

Additional testing can also be important in an environmental monitoring program including testing for foodborne pathogens such as Listeria or Salmonella, or aerobic plate count (APC). A well-designed environmental monitoring program can be used to identify hotspots, check the validity of food safety programs, and indicate trends: control, trending out of control (early warning), or requiring corrective action.

If environmental testing detects an environmental pathogen or indicator organism on a product contact surface, then the facility may consider conducting end-product testing to determine if the product was contaminated. Various detection systems can be utilized to accomplish this including lateral flow, molecular and DNA based solutions – all which could be part of a facility’s environmental monitoring program.

It’s important to remember that the plans and protocols deemed necessary for a facility are accurately recorded in detail. Upon inspection, the FDA will ask for documents showing the implementation of the food safety plan, the hazards that has been identified, how hazards have addressed, SSOPs, and records relating to the validation and verification of an environmental monitoring program.

Neogen has created a specific website (www.Neogen.com/fsma/) dedicated to FSMA, where more information as well as specific products can be found.