The US FDA Food Safety Modernization Act (FSMA) aims to ensure the safety of the U.S. food supply by shifting the focus from responding to contamination to preventing it. The FDA has issued several rules under FSMA and one of them is Preventive Controls for Human Foods (PCHF). PCHF rule requires each food facility to implement a written food safety plan that focuses on preventing hazards in foods using Hazard Analysis and Risk-based Preventive Controls and updated Good Manufacturing Processes (cGMP). The PCHF requirements specify that manufacturing facility’s hazard evaluation must include an evaluation of environmental pathogens such as Salmonella or Listeria monocytogenes, whenever a ready-to-eat (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. Environmental pathogen is defined as a pathogen capable of surviving and persisting within the manufacturing / processing environment such that food may be contaminated and may result in foodborne illness if that food is consumed without treatment to significantly minimize the environmental pathogen.

The environmental monitoring program (EMP) is a verification activity (and not control measure) and an effective EMP diligently tries to find the pathogens or indicator organism in the environment before they affect the product. The primary objectives of environmental monitoring are to verify or confirm the effectiveness of sanitation and zoning controls, find pathogen harbourage sites in facility, and ensure that corrective actions have eliminated Salmonella or Listeria monocytogenes and harbourage sites when found in facility. PCHF requires written procedures and complete documentation for EMP. The EMP uses a risk-based approach in establishing strategies for environmental monitoring (e.g., environmental sampling, sampling sites and frequency, test procedures, and corrective actions) based on the characteristics of RTE food products, processing methods used, ingredients used and any history with past environmental pathogens. The types of corrective actions can vary depending on specific situation and risk, whether environmental pathogens are detected on non-food contact surface or food-contact surface. The environmental sampling test results should trigger activities such as intensified cleaning and sanitizing, intensified sampling and testing, comprehensive investigation and root cause analysis, “hold and test” procedures etc. It is also expected that the facility carries out trend analysis and interpretation from environmental monitoring and product testing data over time.

When FDA finds that a manufacturer has significantly violated FDA regulations, FDA notifies the manufacturer often in the form of a Warning Letter. Several warning letters citing non-compliance to environmental monitoring requirements of PCHF were issued to various food facilities manufacturing RTE foods – candies, snack food, nuts, bakery products, ice cream, salads and RTE spice. A summary of observations related to EMP from some of the recent warning letters issued to US food manufactures recently is provided below (observations in these warning letters may also relate to other requirements of PCHF rule):

• Facility did not establish and implement adequate written procedures for environmental monitoring;
• Facility’s hazard analysis did not identify Salmonella or Listeria monocytogenes as an environmental pathogen requiring a preventive control;
• FDA lab analysis of environmental swabs from food-contact surfaces collected during inspections found positive for Listeria monocytogenes or Salmonella;
• FDA’s Whole genome sequencing (WGS) analysis indicating the presence of a resident pathogen over a time,recurring presence of pathogen;
• Additionally, the strain of pathogen was genetically identical to one clinical isolate collected in previous years, which indicates this strain has the capability of causing human illness;
• Presence of the same strains of environmental pathogen over multiple years indicates there have been multiple resident pathogens or harbourage site in facility over time.
• As evidenced by environmental findings that indicate a resident strain of L. monocytogenes in facility, environmental pathogens are a hazard in facility; the sanitation controls are not adequate to ensure that facility is maintained in a sanitary condition to significantly minimize or prevent the hazard of the environmental pathogen. Additional measures may be needed in facility to address pathogen.
• Facility did not perform an investigation to locate a potential source of contamination or make any changes to sanitation practices.
• The number and location of sampling sites as well as frequency of sampling are not adequate to determine whether sanitation preventive controls are effective and adequacy of intended corrective action.
• Facility did not implement written corrective action procedures to address the presence of an environmental pathogen or appropriate indicator organism detected through EMP

The issue of warning letters by FDA to US food manufacturers clearly indicates the failure of manufacturing facilities to satisfactorily address the concerns/observations made during previous inspections, failure to implement corrective actions based on environmental sample test results and trend analysis etc. The review of recent warning letters also indicates lack of understanding of – regulatory requirements for EMP, the role of EMP in implementing preventive controls, test data interpretation and necessary corrective actions to be taken.

The Indian food industry (exporters to USA) must take cues from these warning letters and implement EMP in their facilities with rigour, if not being done or strengthen their existing programs. Dedicated teams could be identified and trained on environmental pathogen monitoring-including sample collection & handling, tools for collection, testing and analysing data. If implemented effectively, the manufacturing facilities can derive great value from their environmental monitoring programs and get actionable results for enhancing food safety assurance and regulatory compliance.

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