Each year roughly 48 million people get sick, 128,000 are hospitalized, and 3,000 die from
foodborne illnesses according to the CDC. As our food supply becomes progressively more
globalized, the need to strengthen food safety systems in and between countries has become
much more apparent.

Legislation like the Food Safety Modernization Act (FSMA)now enables the Food & Drug
Administration (FDA) to better protect consumers by strengthening food safety systems for
foodborne illnesses, which are mostly preventable and are a significant public health burden.
With the creation of FSMA, the FDA has become more proactive towards food safety
prevention. One solution to the ever-growing issue of foodborne illness is the inclusion of a
robust Environmental Monitoring Program (EMP).

Understanding Environmental Monitoring

According to FDA rule Verification of Implementation and Effectiveness CFR 21 section 117.165
and the Food Safety Modernization Act (FSMA) Final Rule for Preventive Controls for Human

A facility who has identified a potential environmental pathogen or indicator organism
as a hazard to ready-to-eat (RTE) foods are required to include an EMP in their food
safety plan. A trained Preventive Controls Qualified Individual (PCQI) needs to review
EMP test results to ensure that the Food Safety Plan is being followed.

It is necessary for a FSMA EMP compliant Food Safety Plan to include:

  •  Established, written and scientifically valid procedures
  •  Identified testing microorganisms, adequate locations, and number of collection sites
  •  Identified timing and frequencies for collecting and testing samples
  • Identified Corrective Action Procedures in compliance with CFR 21 section 117.150
  •  Testing performed by an accredited laboratory.

The Benefits

The purpose of an EMP is to identify problem areas where potentially harmful microorganisms
may be harboring, becoming a source of contamination; as well as verifying the effectiveness
of sanitation programs. Several benefits of an EMP include:

  • Validation and verification of cleaning and sanitation programs. i.e., procedures and
  • Provides data of the overall effectiveness of your sanitary program, personnel
    practices, and operations procedures
  • Provides data about indicator organisms, spoilage organisms, and pathogens to
    prevent outbreaks
  • Determines if facility maintenance is required, i.e., filter changes
  • Acts as a baseline microbiological assessment of a facility’s environment
  • Helps users find and eliminate potential contamination sites before it has spread

Areas of Concern

There are many routes environmental pathogens and other harmful organisms can be
introduced directly into your facility. Some of these routes are by raw materials, ingredients,
supplies, equipment, and vehicles, as well as personnel, visitors and pests. Two harmful
pathogens to keep track of are Salmonella and Listeria.


Salmonella is a widespread and resilient bacteria that is found in the environment. It can
survive in “dry” manufacturing environments, as well as “wet” manufacturing environments.
Essentially, it is a versatile bacteria that has the potential to causes harm when you
aren’t proactive.

According to the CDC, Salmonella causes around 1 million foodborne illnesses, 19,000
hospitalizations and 380 deaths in the United States annually.

Not only can Salmonella result in foodborne illnesses, but it can also result in a costly recall for
your company. FDA currently considers Salmonella to be the top environmental pathogen of
concern in low moisture foods. Outbreaks and recallscaused by Salmonella have been linked
to raw chicken, ground beef, pre-cut melon, and breakfast cereals. There is also a history of
recalls in tree nuts, nut butter, alfalfa sprouts, cantaloupes, and chicken.
Our article “Salmonella- The Most Common Bacterial Foodborne Disease”goes into detail
about Salmonella and effective ways for you to prevent it in your facility.


Listeria bacteria is prevalent in the environment. It is found in soil, water, and
decaying vegetation.There are six types of listeria, but only Listeria
monocytogenes (L. monocytogenes) is considered harmful to humans.

L. monocytogenes is persistent in and around equipment and the processing
environments in harborage sites. It can survive and grow at refrigerated
temperatures, tolerate high salt concentrations such as a brine tank, and
survive frozen storage for extended periods. Due to these factors, L.
monocytogenes presents a severe food safety concern.

According to CDC, L. monocytogenes causes about 1,600 foodborne illnesses and 260
people deaths in the United States annually. Outbreaks and recalls are regularly linked to
ready-to-eat RTE sliced meats, frozen vegetables, packages salads, dairy products, and

How to be Proactive

To systemically combat these pathogens, a robust Environmental Monitoring Program usually
utilizes zoning concepts. Zones are a useful tool that can help you in site selection within your
facility. The EMP zoning concept divides risks into four zones based on the level of risk to
product contamination with Zone 1 being the highest.

Zone 1– Direct or indirect Food Contact Surfaces (FCS), i.e. product conveyors, product
chutes, storage hoppers, slicers, worktables and employee hands.

Recommended testing for zone 1 are:

  • Aerobic Plate Count (APC)
  • Enterobacteriaceae (TEB)
  • Adenosine Triphosphate (ATP) rapid testing

Pathogens need to be tested in special circumstances such as a response to Positive
Salmonella product result.

Zone 2– Non-FCS that are adjacent to or close to zone 1, i.e., equipment supports, frames,
control panels, weight scales, floor drains and air filters.

Recommended organisms to be tested:

  • Salmonella spp
  • Listeria spp

Both of these tests need to be performed weekly.

Zone 3– Non-FCS within process area but further
removed from product contact surfaces in open
product areas, i.e., forklifts, walls, floors, ceilings,
wash stations and brooms.

Recommended organisms to be tested:

  • Salmonella spp
  • Listeria spp

Both of these tests need to be performed weekly.

Zone 4– Non-FCS outside of the processing areas,
i.e., locker rooms, cafeteria, hallways, trash areas,
wash stations outside of production areas and
loading docks.

Recommended organisms to be tested:

  •  Salmonella spp
  •  Listeria spp

Both of these tests need to be performed weekly.

If you find a positive environmental result in any of the zones, immediately quarantine the
area and put affected product on hold. Next, thoroughly investigated the area both visually
and with microbial testing.

Understanding Vector Swabbing

The best way to investigate a positive
environmental result is with vector swabbing.
Vector swabbing determines the extent of the
contamination and to establish potential root
causes of the contamination.

Diagram is courtesy of the PEM Guidance on Environmental
Monitoring, Almond Board of California

Vector swabbing involves sampling of multiple environmental sample sites around the initial positive site in a radial patter. This approach gives you the best possible coverage of
the environment.

What to remember when swabbing:

  •  Vector swabbing needs to be sampled before cleaning the initial positive site.
  • Make sure the area is thoroughly cleaned and sanitized, taking great care not to
    spread the contamination to surrounding areas.
  •  Take additional environmental after the cleaning process.
  • You need to obtain three consecutive days of negative results until you can return to
    your regular EMP.


After you have established your zones and your
proposed action plan in the event of a positive environmental sample, you now need to
samples the intended sites. Various methods can be used for collecting environmental
samples such as sterile swabs and sponges. When collecting these types of samples, the
surface area sampled can vary depending on the target site. An acceptable sampling area for
indicator organisms is 40-200 in 2 and for pathogens is 40-400 in 2 .

If the sampling collection is post sanitizer application, make sure the sterile swab and
sponge has a neutralizing buffer. The neutralizing buffer counteracts cleaners and sanitizers
that have been used- we want to find any surviving bacteria if they are present. Environmental
samples are to be promptly submitted to an accredited Laboratory for testing. Ideally,
environmental samples should be transported <45 o F and processed within 48 hours.

Next Steps

The cost of environmental contamination can be high, so you must ask yourself what risk you
are willing to take? To save yourself a lot of trouble ensure you have an effective and robust
Environmental Monitoring Program!

With one, you can guarantee that you find any potential contamination risk and eliminate it
before any possible cross-contamination of your product occurs. It is important to remember
that commitment is needed throughout the facility, from senior management and cascading
down to the rest of the workforce. Sufficient resources, both in capital and personnel to do an
adequate job are also needed, and while the thought of creating a new EMP may seem like a
daunting task, the outcome is not only beneficial for your facility but also to the consumer.

Safe Food Alliance offers an online course for Environmental Monitoring to help you
understand what Environmental Monitoring is, what the requirements for FSMA are, and other
information to help with creating and understanding your Environmental Monitoring

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