Learn what controls your Environmental Monitoring Program (EMP) should include to prevent pathogens from entering your facility and what common pitfalls to avoid for more effective pathogen containment. Presenter: Mary Hoffman | Director, Food Safety | The Acheson Group Watch the Replay: https://youtu.be/A9QNk9sqsLk Related Resource - Free eGuide: 5 Keys to Building a Better Food Safety Culture https://info.safetychain.com/download-5-keys-building-better-food-safety-culture

1. FSMA Fridays Webinar Series
Monthly Industry News, Updates & Trends for Food, Beverage, & CPG Manufacturers
Mary Hoffman
Director, Food Safety
Environmental Controls:
Keeping Pathogens Out

2. ✔Monthly FSMA Related News
✔Regulation Changes & Updates
✔Industry Trends
✔Q&A with TAG
What is FSMA Fridays?
FSMA FRIDAYS
A global food safety and public
health consulting group made up
of seasoned industry experts
A digital plant management
platform to ensure quality,
maximize yield & optimize labor
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3. ✔Only panelist microphones are on
✔Ask questions! (Q&A at end)
✔Recording link will be shared
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Watch prior FSMA Friday recordings at
safetychain.com > Resources > FSMA Friday
Before We Get Started…
FSMA FRIDAYS

4. Meet Your FSMA Friday Speaker
FSMA FRIDAYS
Mary Hoffman
Director, Food Safety
Mary holds 19+ years experience in food
safety/quality program development and
continuous improvement, and currently leads
proactive initiatives such as supply chain risk
mitigation, allergen control, environmental
controls & monitoring, and behavior-based
food safety culture programs.

5. FSMA FRIDAYS
FSMA FRIDAYS
FSMA: Regulatory Updates from the FDA
FDA Compliance Guides:
• Small Entity Compliance Guide: Requirements for Additional Traceability Records for
Certain Foods: What You Need to Know About the FDA Regulation
• Draft Compliance Policy Guide on Major Food Allergen Labeling and Cross-Contact
VQIP Portal will close on May 31, 2023 for FY2024 benefits

6. FSMA FRIDAYS
Keeping Pathogens Out: Why it Matters
• Salmonella spp.
• Listeria monocytogenes
• Escherichia coli O157:H7
3,000
deaths
48
million foodborne
illness cases
128,000
hospitalizations
$70M
economic cost
to single
business

7. FSMA FRIDAYS
Where do pathogens come from?
Listeria monocytogenes
• Widely distributed in nature
• Soil, water, vegetation and the
feces of some animals
• Wet and cold areas of the facility
• Areas where food and water are
present (cracks, hard to clean areas)
Salmonella spp.
• Found in guts of warm-blooded animals
• Excreted in feces
• Tolerates heat, and dry conditions
• Harborage is where foods accumulate

8. FSMA FRIDAYS
How do pathogens get in?
Raw products, ingredients
Packing materials
People
Pests

9. FSMA FRIDAYS
Once they’re inside the plant…
Moves around in facility
Stick to niches & hard-to-reach areas
Take up residence
Contaminate food and food contact surfaces

10. FSMA FRIDAYS
Environmental Control Strategy
Control Growth
•Control of water
•Sanitary design of
equipment and facilities
•Frequency of cleaning
and sanitation
•Time/temp control
•Zoning areas
Kill or Remove
•Cleaning and sanitation
•Sanitary design of equipment
and facilities
•Inactivation technologies
Prevent Entry
•Raw material control
•Pest control
•Construction and
visitor procedures
Adapted from: Benjamin Warren, Food Safety Director,
Land O’Lakes, inc. IAFP European Workshop 2012.
Control Transfer
•Raw material and personnel
traffic patterns
•Separation of pre- and post-
lethality areas
•Control of sources (niches)
•Control of vectors (air,
contact surfaces and water)

11. FSMA FRIDAYS
Supply Chain Controls
Ingredients/Materials
• Who controls the hazard, you or the supplier?
o Hazard analysis of ingredients/materials
o Verification activities
Sanitary Transportation
o Food safety expectations
External Partners
o External warehouse
o Contract manufacturers

12. FSMA FRIDAYS
Environmental Controls: Segregation
Raw
-vs-
Ready-To-Eat (RTE)
Dedicated Equipment,
Utensils & Tools
for each section
Wet
-vs-
Dry
Personnel
Risk-Based Controls

13. FSMA FRIDAYS
Environmental Controls: Segregation
Hygienic Zoning
● Hygiene requirements for different zones/areas based on risk of
contaminating product
● Ready-to-Eat production facilities
● Assessment of facility

14. FSMA FRIDAYS
Environmental Controls: Hygiene Areas
Define hygiene areas
Assessment & Mapping
Barriers: physical or procedural
Transition areas
Traffic: people, walk-through flow

15. FSMA FRIDAYS
Environmental Controls: Good Manufacturing Practices
Personnel
● Training and General Awareness
● Well-defined and communicated expectations
● Personal hygiene & cleanliness
● Uniform & personal protective equipment (PPE) expectations
Behaviors
● Routine monitoring
● Cross-functional walkthroughs to create ownership
● Assess plant conditions
● Proper disposal and waste
Food Safety Culture

16. FSMA FRIDAYS
Environmental Controls GMPs: Maintenance
Tools
● Regularly cleaned, inspected, and sanitized
● Dedicated tools
Equipment
● Sanitation after maintenance
● “Clean before use” program
Maintenance Personnel
● Ensure everyone understands flow of traffic & hygiene areas
Construction/Maintenance Planning
● Communication
● Control contamination

17. FSMA FRIDAYS
Environmental Controls: Controlled Conditions
● Temperature, humidity
● Keep dry areas dry
● Control and eliminate condensation
● HVAC units (cleanable, accessible)
● Avoid high-pressure water and compressed air for cleaning
Controlled conditions prevent the
growth and spread of pathogens

18. FSMA FRIDAYS
Environmental Controls: Sanitary Facility Design
● Cleanable
● Resistant to deterioration from chemicals
● Designed to address separation of hygiene areas
● Designed to support practices:
○ Wet-clean practices: wash-down capable rooms
○ Dry-clean practices: ventilation, dust collection
● Able to control condensation
● Floors, drains, walls, ceilings, junctions
Facilities and equipment should be:

19. FSMA FRIDAYS
Environmental Controls: Facility Exterior
● Roads/walkways/parking lot surfaces
● Water drainage
● Walls
● Vegetation control
● Roof
● Entryways/openings
● Site security
● Equipment storage
Facility Maintenance: Exterior

20. FSMA FRIDAYS
Environmental Controls: Sanitary Design
Risk Management
● Identify and Evaluate risks
● Collaborative teams
● Enhanced cleaning and sanitizing
● Routine inspection, testing, preventive maintenance
Modify Infrastructures and Controls to Reduce Risk
● Consider infrastructure
● Consider equipment replacements
Upgrade Equipment

21. FSMA FRIDAYS
Environmental Controls: Facility Maintenance
● Potable water
○ Municipal water vs. private well
○ Where are you sourcing water from?
● Prevent backflow between potable and non-
potable sources
● Ice for food contact, use potable water
● Temperature and pressure
Water Supply & Plumbing

22. FSMA FRIDAYS
Environmental Controls: Cleaning & Sanitation
● Critical part of plant operations
● Cornerstone of Good Manufacturing Practices (GMPs)
● Written program based on:
○ Sanitary design of equipment and facility
○ Microbiological profile, production run and history
○ Degree of product exposure to the
line/environment

23. FSMA FRIDAYS
Environmental Controls: Cleaning & Sanitation
● Cleaning removes the grime (soil, particulates, etc.)
● “Grime” can inactivate the sanitizer before it kills the microbes
● If proper cleaning doesn’t happen, grime can build-up!
● Build-up can allow microbes to also build-up!
● Microbe build-up = biofilm
○ Biofilms are highly resistant to sanitizers

24. FSMA FRIDAYS
Environmental Controls: Cleaning & Sanitation
● End of a predetermined production cycle
● What is cleaned?
○ Processing equipment
○ Hand-held tools
○ product catch pans
○ Carts (wheels)
○ Transfer hoses, etc.
● Identify and store clean equipment (designated area)
Routine Cleaning

25. FSMA FRIDAYS
Environmental Controls: Cleaning & Sanitation
● Master Sanitation Schedule
● Infrastructure Cleaning
○ Floors
○ Walls
○ Ceilings, ductwork
● Equipment Cleaning
○ Pumps
○ Scales
Periodic Cleaning

26. FSMA FRIDAYS
Environmental Controls: Cleaning & Sanitation
● Unplanned, unexpected, or “bad” things
● Risk assessment – “Source of Contamination” evaluation
● Increase monitoring activities
Special Cause Cleaning

27. FSMA FRIDAYS
Environmental Controls: Sanitation Verification
● Are the sanitation procedures working?
● Verification will be dependent
● Examples:
○ Measuring chemical concentrations
○ Visual, smell
○ ATP swabs, microbial count swabs
○ Environmental monitoring for pathogens

28. FSMA FRIDAYS
Environmental Controls: Training
● Personalize training
● Significance of each person’s role
in preventing a recall or food contamination event
● Empowerment – protecting others
● Engagement – protecting my job
● Create a food safety culture

29. FSMA FRIDAYS
Environmental Monitoring
● Sanitary facility and equipment design
● Hygienic zoning
● Traffic patterns
● Separation of RTE and non-RTE areas
● GMPs
● SSOPs
● Employee hygiene training
● Water control programs
Environmental Monitoring is a verification program to determine
the effectiveness of your environmental controls

30. FSMA FRIDAYS
What An Effective EMP Will Provide
• A baseline microbiological assessment of a plant’s environment
• Identification of potential sources of microbial contamination and
possible vectors that may harbor or spread contamination
• Verification of the effectiveness of sanitation practices
• Verification of the effectiveness of procedures used to segregate and
control traffic (including personnel and equipment)
• Data to correct problem areas before they pose a risk to product
• Trending data to modify and update programs in response to results
and observations

31. FSMA FRIDAYS
Understand and Control Your Risk
Environmental
Controls
Environmental
Monitoring
Safe Food
Environment

32. FSMA FRIDAY
Questions?
Mary Hoffman
Director, Food Safety
Environmental Controls: Keeping Pathogens Out

33. ✔ FSMA Friday Session Recordings & Content Library
Resources & Future Events
FSMA FRIDAYS
✔ TAG Newsletter
✔ Global Food Safety Consultants: AchesonGroup.com
✔ FSMA Friday LinkedIn Group
✔ Q&A, Articles & Updates … Join FSMA FRIDAYS!
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