Understanding Regulatory Requirements for Food Safety

At NEMIS, we are setting new standards in environmental monitoring, helping your facility to manage food safety risks for Listeria, Salmonella, E. coli, and ATP. Our cutting-edge solutions are designed to proactively identify and address risks, transforming the way food safety is upheld in production environments.

Our N-Light™ is your key to secure, efficient and auditor approved food production

Understanding Regulatory Requirements for Food Safety

Maintaining a robust environmental monitoring program (EMP) is essential for food production facilities to demonstrate compliance, ensure food safety, and stand confidently in front of auditors. Implementing the correct sampling strategy signals that your business takes contamination control seriously, reducing the risk of penalties or non-compliance reports.

In the United States, environmental monitoring in food production facilities is a critical component of food safety management, particularly for ready-to-eat (RTE) products. The U.S. Food and Drug Administration (FDA) emphasizes a risk-based approach tailored to each facility’s specific conditions, rather than prescribing a fixed number of samples or samplers. NEMIS can help your facility efficiently and effectively comply with food safety regulations.

Did you know?

Stringent on-site environmental monitoring testing can significantly cut the need for physical sample transport, lowering CO2 emissions. At the same time you can reduce your ecological footprint by 15%

Key considerations for environmental monitoring programs (EMPs)

Risk
Assessment
Facilities should conduct a thorough risk assessment to identify potential contamination sources and determine appropriate sampling locations and frequencies. This assessment considers factors such as the types of products processed, facility layout, and historical data on contamination.
Environmental monitoring programs
The FDA mandates that facilities develop and implement strategies to control pathogens, with environmental monitoring serving as a verification activity to ensure the effectiveness of sanitation controls. Facilities should conduct a comprehensive hazard analysis to develop an EMP tailored to the facility's specific risks.

High and Low-Risk Zones: Food Facilities

ZONE 4 locker rooms, cafeteria, halls, warehouse, loading dock
ZONE 3 phones, hand trucks, forklifts, walls, floor and drains
ZONE 2 nonproduct contact surfaces in close proximity to product (exterior of equipment, chill units, framework, equipment housing)
ZONE 1 product contact surfaces (slicers, conveyors, peelers, strip tables, utensils, racks, work tables, employee hands, dicers, pumps)
Zones relate to differing levels of risk
  • Zone 1 – highest theoretical risk and is defined as all/any piece of product contact surface
  • Zone 2 – is in adjacent areas to open product and where indirect contamination can occur
  • Zone 3 – requires some vector to transfer the contamination to Zone 1 or 2
  • Zone 4 – is typically outside a high care environment, and cross contamination typically indicates a failure in barrier control
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New N-Light™ environmental screening

Our N-Light™ environmental monitoring solution sets a new standard for food safety, ensuring your facility remains audit-ready and free from contamination.

Easy, Rapid, and Reliable

Designed to integrate seamlessly into your existing processes, delivering fast and accurate pathogen detection.

Advanced diagnostic tools and data management systems

We help your quality control department to make more informed decisions through our advanced tools and intuitive dashboard.

Our effective environmental monitoring program includes

Our specialists can evaluate your current sampling strategy and recommend a tailored solution to meet U.S. regulatory demands.

  • 1 Identification of sampling sites and zones.
  • 2 Established sampling procedures and frequencies.
  • 3 Defined corrective actions for positive findings.
  • 4 Regular review and adjustments of the program based on findings and operational changes.
  • 5 Documentation & Training.

Consider your sampling needs:
N-Light™ MaxiSampler vs N-Light™ swab

Patent pending
By choosing the right tool for each surface type and size, you can meet regulatory guidelines effectively while maximizing sampling efficiency and accuracy. Learn more

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