Pathogen Listeria Monitoring Services

  1. Purpose

                1.1.        To provide services in developing, implementing, and monitoring your establishments requirements for protecting Company’s products against Listeria contamination in accordance to 21 CFR 117.130 Hazard Analysis (b)(1) (i), 21 CFR 117.135 Preventive Controls (c)(1)(i)(ii), and 21 CFR 117.165 Verification of Implementation and Effectiveness (a)(2).

                1.2.        The purpose of this service is to provide the programs, policies, procedures (SOPs), forms for records, and training materials for Listeria control to be implemented and monitored by employed personnel.

          1.3.      To comply with cGMP requirements of Part 117 with respect to measures that can significantly minimize or prevent the contamination of food with L. monocytogenes whenever food is exposed to the environment prior to packaging and the packaged food does not receive a treatment or otherwise include a control measure (such as formulation lethal to L. monocytogenes) that would significantly minimize L. monocytogenes.

  1. Introduction

                2.1.        L. monocytogenes is an environmental pathogen that can contaminate foods and cause a mild, non-invasive illness (called listerial gastroenteritis) or a severe, invasive illness (called listeriosis).

                2.2.       Foods that have caused outbreaks are typically contaminated from the environment during manufacturing/processing or packing.

  1. Services

                3.1.        Environmental Monitoring Program

                                3.1.1.     Verification of the effectiveness of environmental control programs for L. monocytogenes;

                                3.1.2.    Monitoring of corrective actions has eliminated L. monocytogenes and harborage sites when found in the plant.

                                3.1.3.    Monitoring of sample collection and testing from Food Contact Surfaces and Non-Food Contact Surfaces

                                3.1.4.    Drafting and Implementing Corrective Actions

                                3.1.5.    Strategies for Environmental Monitoring

                                3.1.6.     Vector Swabbing Protocols and Implementation.

                                3.1.7.    Listericidal Treatment monitoring

                                3.1.8.    Food Formulation Controls

                                3.1.9.    Handling Controls

                              3.1.10.    Shelf-Life Controls

                              3.1.11.    Storage Controls 

                3.2.        Sampling Areas

                                3.2.1.    Zone 1 Controls - Food-Contact Surfaces

                                3.2.2.    Zone 2 Controls – Non-food-contact surfaces in close proximity to food and food contact surfaces.

                                3.2.3.    Zone 3 Controls - More remote non-food-contact surfaces that are in or near the processing areas and could lead to contamination of zones 1 and 2

                                3.2.4.    Zone 4 Controls - Non-food-contact surfaces, remote areas outside of the processing area, from which environmental pathogens can be introduced into the processing environment 

                3.3.        Written Procedures for Environmental Monitoring

                                3.3.1.    Scientifically valid

                                3.3.2.    Testing for Listeria spp. or L. monocytogenes;

                                                Location Identification

                                               Timing and Frequency of Sampling and Testing

                                               Testing Methodology

                                               Laboratory Identification

                                              Corrective Action (intensified cleaning and sanitation, sampling, testing, root cause analysis, and implementing “hold and test” procedures).

                3.4.        Preventive Controls per 21 Part 117 requirements development, implementation and monitoring;

                                3.4.1.    Sec. 117.126 – Food safety plan

                                3.4.2.    Sec. 117.130 – Hazard analysis

                                3.4.3.    Sec. 117.135 – Preventive controls

                                3.4.4.    Sec. 117.139 – Recall plan

                                3.4.5.    Sec. 117.140 – Preventive control management components

                                3.4.6.    Sec. 117.145 – Monitoring

                                3.4.7.    Sec. 117.160 – Validation

                                3.4.8.    Sec. 117.165 – Verification of implementation and effectiveness

                                3.4.9.    Sec. 117.170 – Reanalysis

                              3.4.10.    Sec 117.190 – Implementation records required for this subpart.

    4.        Responsibility

                4.1.        Sanitation Personnel

                4.2.        Warehouse and Storage Personnel

                4.3.        PCQI / QC / Qualified Personnel

                4.4.        QC Department Personnel

                4.5.        Compliance Personnel

                4.6.        Senior Management


    5.        Documents (References)

                5.1.        Assessment Checklist

                5.2.        Forms Time / Temperature Logs

                5.3.        Sampling Procedures

                5.4.        Environmental Monitoring Log and Forms

                5.5.        Cold Storage Logs

                5.6.        Lab Submission Forms and Log

                5.7.        Delivery Vehicle Inspection Procedures


-       Title 21-Food and Drugs, Chapter I - Food and Drug Administration, Department of Health and Human Services, Subchapter B - Food for Human Consumption, Part 117 – Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food.

-       Sec. 117.9 Records required for this subpart

-       Control of Listeria monocytogenes in Ready-To-Eat Foods: Guidance for Industry  Draft Guidance, U.S. Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition January 2017