Environmental Monitoring in the

Age of FSMA
Thomas Jones
DFA of California
Environmental monitoring can be defined as
testing the processing environment for
contaminants. Why do we want to do that?

The Raw Ingredients The Numbers &

+ Types of
Determine
The Process Itself
+ Contaminants in
The Processing Environment the Finished
Product.
The Objectives of the Program Can Vary
• Pathogen detection/elimination.
Eliminate niches/harborages.
• Validation and verification of cleaning and
sanitation programs.
Procedures & frequency.
• Determine if plant maintenance is needed.
 Change gaskets, filters.
• Evaluate hygienic design of the facility.
 The Significance of Environmental
Monitoring
• Measures the success of your food safety
programs (Sanitation HACCP GFSI).
• Many foods do not receive a kill step before
reaching the consumer.
• The monitoring functions as an “early warning
system” to detect problems early.
• Contamination=spoilage, foodborne illness &
recalls!
The Costs of Environmental Contamination
Can Be High…
2008-2009 Peanut Corporation of America (PCA):
•Foodborne illness outbreak (Salmonella typhimurium).
•Tied to peanut butter and peanut paste from PCA.
•714 illnesses, 166 hospitalizations, 9 deaths.
•Eventual recall of 3,900 products containing peanut-
derived ingredients.
•PCA is no longer in business.
The FDA Inspection of PCA:
•Lack of adequate pest controls
•Insanitary air circulation system.
•Insanitary food contact surfaces.
•Positive environmental samples for
Salmonella (floor crack, cooler
floor).
•Retesting/releasing (+) lots.

The fallout continues:

•FSMA
•Federal prison sentences.
2011 Jensen Farms (Holly, Colorado):
• Foodborne illness outbreak (Listeria
monocytogenes).
•Tied to whole cantaloupes (Rocky Ford brand).
•147 illnesses and 33 deaths.
•Jensen Farms filed bankruptcy.

The FDA investigation:

•The outbreak strain was repeatedly found:
5/10 cantaloupe samples.
13/39 environmental samples.
Jensen Farms Investigation (con’t).
• Insanitary floor conditions:
Standing water.
Difficult to clean.
• Poor equipment design:
Difficult to clean/sanitize.
Designed for another commodity.
• No pre-cooling of fruit.
• Possible cross-contamination (cattle).
• Possible contamination from growing &
harvesting operations.
 The Stakes Have Gotten Higher
2012 Sunland Farms:
• Foodborne illness outbreak (Salmonella
bredeney).
• Linked to creamy peanut butter.
• 42 illnesses.
• 240 products recalled.
The FDA Investigation:
• Shipped positive lots of product!
• Insanitary design of equipment, floors.
Sunland Products Investigation (cont’d)
• Wet food contact surfaces (in a low moisture
product).
• Inadequate pest control, worker hygiene
practices, sanitation practices.
•28 positive swab results for Salmonella:
Floors, drains, broom bristles, structural
supports, conveyor cover, roaster.
• FDA suspended Sunland’s registration!
New authority under FSMA.
Company went bankrupt.
 What Does FSMA Say?
• “We propose to require environmental monitoring,
for an environmental pathogen or for an appropriate
indicator organism, if contamination of a ready-to-
eat food with an environmental pathogen is a
significant hazard, by collecting and testing
environmental samples”.
• “Environmental monitoring would be a verification
activity to ensure that sanitation controls are being
implemented and are effective.”
-Preventive Controls Rule (September 17th, 2015)
 What Does FSMA Say?
• “For example, environmental monitoring would be
required to verify effectiveness of sanitation controls
when an RTE food is exposed to the environment
prior to packaging and the packaged food does not
receive a treatment or otherwise include a control
measure…that would significantly minimize the
pathogen…”
-Preventive Controls Rule (September 17th, 2015)
 What Does FSMA Say?
• “Foods such as peanut butter, soft cheeses, dried
dairy products for use in RTE foods, and roasted nuts
are among the products for which manufacturing
operations would need to have an environmental
monitoring program when such foods are exposed to
the environment”
- Preventive Controls Rule (September 17th, 2015

• Environmental monitoring is “must do” for most RTE

foods!
 Where Do We Start?
• Pathogen Environmental Monitoring.
Pathogens pose the highest risk.
FDA is focused here.

• Sanitation Verification.
Includes non-traditional methods (ATP).

• Program Management &

Interpretation:
What do I do with this data once I get it?
Pathogen Environmental Monitoring
Pathogen Environmental Monitoring (PEM)
• An ongoing sampling & testing
process that measures the
effectiveness of the pathogen
contamination control measures
in a plant.

• Pathogens of greatest concern

are Salmonella, Listeria and E. coli
O157.
 The Plant Environment
• Pathogens enter the plant in many
ways (raw products, ingredients, pests,
workers).
• Once inside, they persist in niches and
move through the facility (dust, traffic
flow, condensation).
• Grow/survive within the plant.
• This a perfect recipe for
recontamination!
 Concerns with Salmonella
• There are over 2,400 serotypes of
Salmonella bacteria.
• May infect several million
Americans/yr. via tainted food
(CDC).
• Survives well in the environment
and is known to tolerate heat and
dry conditions.
 FDA Perspective on Salmonella
“Salmonella spp. is usually the environmental pathogen of
concern for most dry (e.g. low-moisture) RTE food
environments.”
-Proposed Preventive Controls Rule, FDA

Harborage Sites for Salmonella:

•Areas where food particles accumulate.
Plant environment vs. processing equipment.
•Escape the dry cleaning process.
•Salmonella grows when these areas get wet.
•Eventually contaminate food contact
surfaces.
The Salmonella Control Equation
 The Primary Salmonella Control
Area (PSCA)
• The area with the highest hygiene
requirements (& risks).
• Product is exposed prior to final
sorting/packaging.
• Especially sensitive with post-
lethality-treated product.
 The Primary Salmonella Control
Area (PSCA)
• Should be physically separate
from the rest of the facility.
• PSCA controls include:
Barriers.
Airflow changes/filtration.
Traffic control (people, materials).
Special sanitation measures.
PSCA Example
 E. coli O157:H7
• O157 survives well in the environment
(spinach) and is pH resistant (fruit juices).
• Isolated from food contact surfaces (Ex:
meat processing facilities).
- Not routinely tested in most PEM programs.

• Survival at low moisture?

- Contamination of nuts, wheat flour reported.
- Challenge studies suggest survival ranking of
Salmonella > O157 > Listeria.
 Listeria
• Includes 6 species of common soil
bacteria. One species (Listeria
monocytogenes) is a human pathogen.
• Likes wet areas of the facility (drains,
condensate, chillers).
• Good sanitation & environmental
monitoring are critical to control.
 FDA Perspective on Listeria
“L. monocytogenes is usually the environmental pathogen of concern
for most wet RTE food production environments. It is important to
sample areas where the organisms are likely to be present in
relatively high numbers.”

-Proposed Preventive Controls Rule, FDA

Harborage Sites for Listeria:

•Where food & moisture are present.
•May grow on processing equipment.
•Contaminate food during production.
 Pathogen Comparisons
Listeria
E. coli O157 Salmonella
monocytogenes
Incubation
Time: 3 to 70 days 1-6 days 12 to 72 hours

Infectious
Dose: >1,000 cells (?) <100 cells 10-100 cells
Cases/year:
1,700 73,000 4.8 million
(US)
Death Rate:
30 % 5-10 % <1%
(US)
 Establishing the PEM Program
• Step one is pick your team (like HACCP).
 Sanitation, quality, production,
maintenance, consultants.

• Evaluate the process flow & risks.

 Recontamination threats!
• Define your hygiene areas:
 PSCA.
 Basic GMP Area.
 Non-process Area.
 Establishing the PEM Program
• Based on their findings, the team selects
sampling sites.

• The “swabbing equation”:

Potential Risk = Frequency

• “Zoning” is a helpful concept in site

selection…
 Zone 1 Sites
• Direct product contact surfaces.
• Exposed product prior to package
sealing.
• Examples:
 Conveyors/buckets
 Utensils
 Employee hands (ex: sorters).
 Slicers/pitters.
 Hoppers/bins/bin liners.
 Fillers.
Zone 1 Sites
 Zone 2 Sites
• Non-product contact sites adjacent to
Zone 1.
• Examples:
 Equipment framework.
 Drip shields/housing.
 Control panels/buttons.
 Pipes over Zone 1.
 Computer screens.
 Maintenance tools.
Zone 2 Sites
 Zone 3 Sites
• Non-product contact sites adjacent to
Zone 2 (not Zone 1).
Cross-contamination risk.
• Examples include:
Floors/walls/ceilings.
Hoses/air handling units.
Drains.
Foot mats/baths.
Forklifts.
Brooms/mops
Pallets.
Zone 3 Sites
 Zone 4 Sites
• Areas remote from Zone 1.
 Cross-contamination of Zones 1-3 from
Zone 4 can occur!
• Examples:
 Locker/break rooms, offices.
 Warehouses/freezers/cold storage.
 Restrooms.
 Loading docks.
 Maintenance shop.
Zone 4 Sites
 Taking Samples
• Samples of the plant
environment may include:
 Surface swabs.
 Dust, scrapings.
 Water/air.
• Sampling Tools can include:
 Swabs (sponge & “Q-tip®” style).
 Sterile scoops, spatulas & sample
cups.
 Sample Collection
• Work out from Zone 1 to Zone 4.
• Samplers must practice good hygiene:
1. Wash/sanitize hands.
2. Put on sterile gloves before handling swab.
3. Change gloves/sanitize between swabs.
4. Only non-sterile surface the swab should
touch is the sample site!!
 Sample Collection
• The area sampled can vary:
 40-200 in2 for indicators.
 40-400 in2 for pathogens.

• Wipe Zone 1 sites with alcohol-based

sanitizer after sampling.
• Always submit a negative control swab:
 Removed from bag & returned w/o being used.

• Submit samples promptly!

 Transport < 45 oF.
 Test < 48 hrs.
 Types of Sample Testing:
• Indicator Organisms.
 Non-pathogens.
 Indicators for contamination.
 Examples:
 Aerobic plate count (APC).
 Coliforms.
 Total Enterobacteriacea (TEB).

• Pathogens…
Salmonella Listeria O157
 Sample Testing by Zone
• Zone 1 testing is typically indicators.
 (+) pathogen = product holds/recalls.
 Indicators allow you to quantify
sanitation efforts.
 Sample after cleaning/before sanitizing.

• Zones 2-4 are tested for

pathogens.
 Raw process areas will have some (+)
hits.
 Usually taken during production.
 FSMA PEM Program Requirements
• Procedures must be written and scientifically valid.
• Identify the test organism (pathogen or indicator).
• Locations and number of test sites:
– “must be adequate to determine whether
preventive controls are effective”.
• Test methods used and testing laboratory identified.
– Recommend accredited laboratories.
• Identify Corrective Action Procedures.
 Sampling Summary
Microbiological Minimum
Examples of Sampling Typical Number
Zone Frequency of
Sites Test of Samples
Sampling
Indicator
Organisms Weekly, post-
Product Contact Site
cleaning pre-
1 (conveyers, hoppers, (APC, coliforms, sanitizer
Line Dependent
utensils, etc.) TEB) pathogens application.
sometimes.

Adjacent to Zone 1
2 (framework, control Pathogens Weekly 10-15
panels, catwalks, etc.)

Further From Zone 1

3 (forklifts, floors, drains, Pathogens Weekly 10-15
walls, brooms, etc.)

Outside the Process

Area (warehouse, plant
4 entrance, restrooms,
Pathogens Monthly 5-10
office, etc.)
 Sampling Frequency
• Initial sampling is intensive to establish
a baseline…
 25-50 swabs/zone/day for a month!
• Routine sampling:
 Weekly in Zone 1 (# can vary).
 10-15/week in Zones 2-3.
 5-10/month in Zone 4.
• Rotate sites.
 Allow monitor discretion in site
selection
 Test each site 4 times/year.
 The Results…
• The quantitative data from Zone 1 can be
used to evaluate sanitation programs:
 Pathogen Results
• A response for (+) pathogen results is
essential. Some typical corrective
actions:
 Cease production/quarantine the affected area
(& product if zone 1).
 Vector swab site & adjacent areas (zones 2&3).
 Breakdown lines for inspection, swabbing &
cleaning (zones 1&2).
 Thoroughly clean site (50 ft. radius, zones 3&4).
 Increase sampling frequency to daily until 3 (-)
results occur.
Example of Vector Swabbing
 Positive Result Follow-up…
• Reassemble your team.
 Root cause investigation (what happened?).
 Review facility practices.
 Possible causes include:
Maintenance/construction events.
Structural damage/roof leaks.
Changes in personnel, traffic patterns.
Changes in cleaning/sanitation.
 Positive Result Follow-up…
• Use the team’s findings to improve
operations:
Reinforce training (GMPs).
Cleaning/sanitation.
Repairs/improvements.
Traffic patterns.
 Positive Result Follow-up…
• Proper disposition of product
(zone 1 positive).
 Product placed on hold.
 Product can be re-worked or
condemned.
 Validated processes only.

 Testing alone is not a suitable

method of clearing product!
 Recurring Positive Results
• May indicate the presence of a resident strain:
 Become established in “tough to clean areas”.
 The same strain reappears and can contaminate
product over long periods of time.
S. agona persisted for 10 years in a cereal facility!

• Transient strains:
 Are “just passing through”…
 Generally eliminated by cleaning/sanitation.
Example of a Resident Strain:

Equipment
isolates are
different from
the fruit,
irrigation
water, etc!

Cantaloupe Study from Texas A & M (Duffy et. al, JFP, 2005)
 Documentation
•Monitoring:
Procedures & methods.
Training records
Assignment list.
Pre-operation Inspection logs.

•Corrective Action Records.

•Hold/Release Records.
 General Record-keeping Requirements
(Subpart F)
• Original records, true copies or electronic.
• Must be accurate, indelible and legible.
• Contain actual observations, values.
• Created concurrently with the activity.
• Identify facility, date and time of activity.
• Signature or initials of creator.
• Retained for at least 2 years.
• Be retrievable within 24 hrs. of request.
 Two Recurring Issues with Programs
1.Not Enough Samples Are Taken.
-Too much time between samplings.
-Not enough samples/day or zone.
2.Positive Results Are Not Correctly Dealt
With.
-Pathogen hits require immediate response!
 The Value of a PEM Program
• It can make your operation better.
 Eliminate niches/hot spots before they cause
trouble.

• Demonstrates your food safety

competence to visitors.
 Auditors, buyers & regulators.

• A powerful training tool!

 Can bring food safety home to workers!
Questions on PEM?!
Sanitation Verification
 So What is Sanitation Verification?
• A pre-operational examination of the food
processing equipment/facilities.
Emphasize Zones 1 & 2.

• Determines if cleaning & sanitation have been

effective.
• Establishes corrective steps to be taken if sanitation
has been inadequate.
• Provides documentation of this process.
 Verification Techniques
Two of the oldest methods around use our own
senses…

Look for visible product

residues, scrape for biofilms.

Smell for spoilage/microbial growth

(fermentation, rancidity).
 Verification Techniques
• Microbiological swabs from the PEM
program.
• Key indicator organisms can also include:
Yeast/Mold Counts (major spoilage organisms).
Coliforms (sanitizer effectiveness).
E. coli (FDA allows <0.36/gram in tree nuts).

• Waiting for results is a disadvantage…

Chemical Methods of Verification
• ATP/Bioluminescence.
– Detects food residues/microbes.
– Limit of Detection = 1,000 microbes.
• Allergens
– ELISA Kits
– Specific for each type.
• Protein
– Can be used for allergens.
– Not sensitive enough for microbes.
 ATP/Bioluminescence
• Some drawbacks:
Calibrate for each process line (ATP levels vary).
 Doesn’t always work in a dry process:
Almond Huller

Micro Data ATP data

(black) (clear)

Source: Du, et. al, FPT, 2007

 Establishing the Verification Program
• Same approach as establishing the PEM:
– Assemble your team.
– Establish sampling sites.
– Determine your limits:
• Industry standards (ABC data).
• Collect your own baseline data
– Set up routine monitoring:
• Weekly for micro.
• After each sanitation cycle (ATP).
Establishing the Verification Program
• Results > Acceptable Limit = Sanitation Failure
• A failing result requires a response!
• Corrective actions include:
Repeat sanitation & verification
(visual/ATP/allergen).
Product holds, review of sanitation practices &
product testing (microbiological swabs).
Documentation is critical!
 Data Interpretation
• Tracking the data from each monitoring site
can detect problems with sanitation:
 Positive trending: value = sanitizer efficacy
 Increased variability = inconsistent cleaning.
 Increased readings & variability: cleaning and
sanitizing are both in trouble!
Success in Sanitation = Success in Swabbing!

With that in mind, let’s review sanitation basics…

Sanitizing Without Cleaning is Pointless
• Soils can inactivate the sanitizer before it
kills the microbes. Ex: Hypochlorites and
proteins.
• Microbes will form biofilms on a dirty
surface.
• Biofilms are highly resistant to sanitizers..
Birth of a Biofilm
90 Minute Exposure to 4 ppm Chloramine

Green (dead cells) Red (living cells)

 Listeria spp. form biofilms
on many surfaces (stainless
steel, rubber,
polypropylene).

Biofilms can survive heat

treatments, various
sanitizers (hypochlorite,
periacetic acid, quats).
Biofilm (+) strains Biofilm formation increases
Salmonella survival in dry
environments…

Biofilm (-) strains

Iibuchi, et. al., J Food Protection 73(8) 2010, pp1506-1510

Questions on Sanitation
Verification?
 Concluding Remarks
• Environmental monitoring is your “early
warning system”!
• Measures the performance of your food
safety programs.
• Shows regulators & customers that you
are serious about food safety.
• Provides valuable legal protection.