XXXXXXXXXX Rev.
December 20, 2022
ENVIRONMENTAL MONITORING PROGRAM
RISK ASSESSMENT
Risk assessment has been conducted to build the environmental monitoring program (EMP)
that meets the specific needs of XXXXXXX:
a) Relevant microbiological hazards has been defined
Potential microorganisms of concern for water are Total Coliform & E. Coli as
bacterial indicators that are used to verify the quality of the drinking water (Health
Canada, Overview of the Microbiological Aspects of Drinking Water Quality,
March 20, 2021). With regards to other potential hazards (e.g., microbiological,
general chemical & physical, inorganic, etc.), XXXXXXX relies on the
government testing reports (Drinking Water Analysis Summary and Drinking
Water System Annual Report, city of Toronto)
Potential microorganisms of concern for air are Yeast & Mold as spoilage
organisms commonly used to verify air quality in food product facilities (Diversity
and Control of Spoilage Fungi in Dairy Products, Science et Technologie du Lait,
France, July 2017; Occurrence and Growth of Yeasts in Yogurts, University of
New South Wales, Australia, July 1981; Quality of Yogurt, Journal of Dairy
Science Vol. 59, No. 2; Codex Alimentarius; Microbiological Air Quality in
Processing Areas in a Dairy Plant, Brazilian Journal of Microbiology, 2003)
Potential microorganisms of concern for surfaces is Listeria m. as pathogen
commonly found in wet environments and drains (Listeria Policy, Health Canada,
2011; FSSC 22000 Guidance Document: Environmental Monitoring, 2022;
Control measures for Listeria monocytogenes in ready-to-eat foods, Preventive
Controls, CFIA, February 2022). Also, in this category is included E. Coli as an
indicator organism associated with areas where fecal contamination may occur,
such as personnel hands (FSSC 22000 Guidance Document: Environmental
Monitoring, 2022; E. coli and Foodborne Illness, US Food & Drug Administration,
2020)
b) Zones of risk related to the different hazards have been defined. A recommended
method to organize the EMP is the zoning concept, where the facility is divided into
several zones (FSSC 22000 Guidance Document: Environmental Monitoring, 2022;
Control measures for Listeria monocytogenes in ready-to-eat foods, Preventive Controls,
CFIA, February 2022). This allows adapting a sampling and testing strategy to each
zone individually. Zones can be defined according to specific criteria, such as the level of
risk contamination, processing steps or the nature of the food. So, for XXXXXXX
the Zoning has been established as Zone 1 (food contact surfaces (FCS), locations
where the risk is higher because the surfaces are in contact with the product) and
Page 1 of 3
XXXXXXXXXX Rev. December 20, 2022
Zone 2 (non-food contact surfaces (NON-FSC), locations near food and food contact
surfaces and remote non-food contact surfaces, such as forklift, stairs handrails, etc.)
Sampling points are outlined in XXXXXXX Listeria & Other Pathogen Control Program,
2022
c) Suitable monitoring techniques have been defined:
Sample types, such as swabs, water samples, and air plates. Additionally, ATP
swabs are used for the verification of cleaning. XXXXXXXLtd. carries out regular
environmental sampling to verify the effectiveness of its sanitation program for
detecting Listeria in the plant environment. Also, the regular ATP swabbing is
performed as a verification of Listeria swabbing. The purpose of the
environmental swabbing is to assess the effectiveness of sanitation and other
GMPs in XXXXXXXLtd. facilities and reduce or eliminate a risk of product
microbiological contamination. In addition, by detecting and responsibly
responding to each positive result, consumer risk can be minimized.
Environmental swabbing includes routine sampling of FCSs, defined as Zone 1,
that come into contact with exposed XXXXXXXLtd. products before final
packaging, and non-FCSs, defined as Zone 2. Routine sampling is conducted in
accordance with a Compendium of Analytical Methods, MFLP-41 (Health
Canada)
Sampling tools such as Sanicult swabs, ATP swabs, PDA air plates, etc.
Sampling techniques as per the government guidance (Appendix B – Collection
and Transportation of Samples: Applicable to All Methods in the Compendium of
Analytical Methods, Government of Canada, 2006; Environmental Sampling for
the Detection of Microorganisms, MFLP-41, Government of Canada, 2010; Air
Quality Monitoring Method – Settle Plates, SOP 3.3, Gelda Scientific, 2001)
Sample sites based on the zoning concept as per company and process
specifics, customer and regulatory requirements, etc. (FSSC 22000 Guidance
Document: Environmental Monitoring, 2022; Control measures for Listeria
monocytogenes in ready-to-eat foods, Preventive Controls, CFIA, February
2022)
Test methods: laboratory based (except for in-house ATP swabbing),
government-approved and compliant to regulatory requirements (The
Compendium of Analytical Methods, Health Canada)
d) Appropriate monitoring frequencies for routine sampling has been defined. Due to the
fact that XXXXXXX typically produces Category 1 RTE food products (Listeria Policy,
Health Canada, 2011), the frequency of sampling is determined based on risk and
inclusive of trends from the previous period. In some situations, products in various
Page 2 of 3
XXXXXXXXXX Rev. December 20, 2022
stages of processing are used as additional samples to further assess the presence of
Listeria and other pathogens
e) Appropriate methods for sample collection, storage and transportation are defined to
ensure the integrity of the sample is maintained prior to analysis (Appendix B –
Collection and Transportation of Samples: Applicable to All Methods in the Compendium
of Analytical Methods, Government of Canada, 2006)
f) Action limits, corrective actions and responsibilities have been defined should any out-of-
specification results be detected (outlined in Section 6, Responsibilities, Section 8,
Tolerances, and Section 10, Corrective Actions in Case of Deviations, of Elite Diary
Listeria & Other Pathogen Control Program, 2022)
g) Verification system for EMP has been defined to comply with ISO 22000, paragraph 8.8
to review the program in case of:
Changes related to products, processes, or legislation, where relevant
Any testing failures related to XXXXXXX products within the scope of the EMP
Any pathogen detection during routine environmental monitoring
There are alerts, recalls, or withdrawals relating to products produced by Elite
Dairy
h) Trending of the results, obtained from EMP, has been implemented followed by
necessary actions to address the results of the trends identified. Trend Analysis results
are included into Annual Key Performance Indicator Analysis as per FSSC 22000
requirements
i) EMP review has been defined to be at least annually, or more frequently in case of any
deviations occurred
Page 3 of 3
