A PEM program should test for a mix of indicator organisms and a mix of pathogens based on
product susceptibility and risk.

A sanitation program is a key component of any food processor’s or food handler’s food safety
plan. A well-written and well-executed sanitation program can mitigate, or reduce to an
acceptable level, all three classifications of hazards (microbiological, chemical, and physical)
in a hazard analysis. Sanitation is one of the four preventive controls (process controls,
allergen, sanitation, and other) in the Preventive Controls for Human Food rule of the Food
Safety Modernization Act (FSMA). Sanitation has long been a major prerequisite program for
Hazard Analysis and Critical Control Points (HACCP). Consequently, it is imperative that the
sanitation program be functioning and performing according to expectations.

Verification is one method of ensuring that the sanitation program is being consistently
implemented and is performing to the expectations of the food safety plan’s hazard analysis.
Verification is one of the seven principles of HACCP.

Many methods are available for verifying the viability of a sanitation program, and most
facilities use a combination of different methods to ensure that the sanitation program is
performing as expected.
Some tools for sanitation verification include:

  • In-process or finished product testing
  • Testing a sanitation cycle for temperature, chemical concentration, flowrate, etc.,
    according to the validated sanitation recipe/procedure
  • Visual inspection: In food facilities, a pre-operational inspection is completed between
    changeovers and before starting production; however, the human eye cannot see a
    microorganism or an allergenic protein, and so caution must be taken if this is the only
    sanitation verification method chosen
  • Records review: Reviewing all log sheets and documentation associated with the
    sanitation program to ensure it was completed according to procedure, and that the
    personnel completed the necessary tasks according to schedule
  • Rapid testing methods including ATP or lateral flow allergen testing
  • Microbial environmental monitoring

Environmental Monitoring Programs
The food processing environment and equipment must be tested for microbiological
contaminants. As previously stated, an environmental monitoring program (EMP) can serve
as a verification tool for a sanitation program. In addition, an organized and well-managed
EMP can save a facility from a potential costly (or business-ending) recall and/or downgraded
product. Aside from recalls and operational efficiencies, there are many more benefits to a
robust EMP including:

  • Serving as an early warning system, enabling the pathogen to be found in the facility
    before it makes its way into the product
  • Identifying potential maintenance issue or harborage locations in the facility
  • Reducing the number of hazards requiring a preventive control or critical control point
    (CCP) in the food safety plan, and controlling the hazard before it increases to a
    preventive control or CCP level
  • Providing a methodology for data collection and trending
  • Meeting customer, third-party, and regulatory requirements.
    Environmental monitoring programs have several common names and acronyms in the
    industry. A quick search through Food Safety Magazine’s archives reveals several including:
  • EM (Environmental Monitoring)
  • EMP (Environmental Monitoring Program)
  • EMPC (Environmental Monitoring Pathogen Control)
  • PEM (Pathogen Environmental Monitoring).
    All have the same purpose—”seek and destroy”—i.e., proactively looking for microorganisms
    on the equipment and in the environment before the product is comprised. There is no “onesize-fits-all” PEM program in the industry, because each PEM program is based on the risks
    unique to each processing facility, equipment, product, people, history, etc. A facility making
    a dairy product will have a much different program than a facility packaging fresh-packed
    potatoes. PEM programs can be expensive and, therefore, must be configured properly to be
    functional and provide the right information to make data-based decisions