Needing to Update The Environmental Sampling Program?

A recent article in Food Safety magazine ( FDA Environmental Monitoring Tactics Have Changed—Have Yours? Bryan Armentroutasks (2022)) asks if your Environmental Sampling Program can hold up to an FDA inspection's sampling regiment. It highlights aspects of the recently updated FDA Investigation Operational Manual - Chapter 4 - Sampling, specifically from this, Section 4.3.7.7.1 Environmental Sampling.

First, one should be aware and somewhat knowledgeable about the FDA Investigations Operations Manual (IOM) and within that, Chapter 4. Sampling.

The author of the Food Safety Magazine article points out keys of what FDA within their environmental sampling regiment may do that may be different than what a company's sampling plan may do.

• "They will not tell you that they are going to sample, until they are ready to start"
• "They are going to sample food contact and indirect contact surfaces"
• "They are not going to sample floors and drains"
• "They are going to sample during production, with a target of four hours of activity after a wet clean"
• "If a positive is found, they are sending it out for identification, adding it to the U.S. Centers for Disease Control and Prevention (CDC) database, and cross-referencing for any outstanding or past food safety incidents."

This does not mean that a company needs to do exactly what FDA does.  We certainly will maintain a focus on Zones 2 to 4 as a way of understanding contaminants with the facility, and focusing on preventing contamination from getting to food contact surfaces (Zone1).  But a company needs to know that Zone 1 is not contaminated and that contamination does not leak out into the facility once production is in full swing.

Selected items from 4.3.7.7.1
INVESTIGATIONS OPERATIONS MANUAL 2022 (https://www.fda.gov/media/75243/download)

4.3.7.7.1 - Environmental Sampling

• Every effort should be made to conduct Listeria sampling when the facility has been in production for at least four hours and before any wet cleaning is performed. In instances with smaller firms that have short production periods, swabbing should be conducted during the mid to tail end of their production schedule.
• In most cases, subsamples for Salmonella will be collected from the Zones 2 – 4 (see below), concentrating primarily on Zone 2. Samples should be collected from the equipment itself, particularly equipment mounting and support structures. When targeting Listeria, swabs will be collected primarily from Zones1 and 2. Perform most of the sampling for Listeria in, on, and around food contact equipment, focusing on areas where food is exposed and being processed, particularly post-treatment/pasteurization.
• A large majority of the environmental samples collected should be taken from Zones 1 (when directed and depending on the organism in question) and 2, and to a lesser degree Zone 3 areas. Very few, if any, environmental samples should be taken from Zone 4 areas.
• Swab subsample numbers for each organism are as follows:
• For Salmonella environmental swabbing, collect at least 100 swabs/subs and ideally 300 or more
• subs
• For Listeria environmental swabbing, collect at least 50 swabs/subs and ideally 100 or more subs.

Also, there can be samples taken for food samples.

Here are the FDA Zone definitions:

Zone 1: Refers to all direct food contact surfaces such as slicers, mixers, conveyors, utensils, racks, work tables, etc. For inspections focusing on the presence of Salmonellae, such as firms producing peanut products and other dry product environments, food contact surfaces are normally not  sampled unless specifically requested in the assignment or CP. In contrast, for inspections focusing on detection of Listeria monocytogenes, such as firms producing seafood or cheese products in a wet environment sampling of food contact surfaces is essential.
• Zone 2: Encompasses the areas directly adjacent to food contact surfaces (Zone 1). For investigations focusing on Salmonellae, this is the area where environmental contamination is most likely to directly affect safety of the product. In a small production room, Zone 2 encompasses all non-food contact  surfaces in the processing area, such as the exterior of equipment, framework, food carts, equipment housing, gears, ventilation and air handling equipment, and floors. In a much larger room (e.g. 20,000 square feet) Zone 2 is the area in the immediate vicinity of food contact surfaces, such as around the exposed product in which you could envision a pathway to product contamination either through the actions of man or machine.
• Zone 3: The area immediately surrounding Zone 2. Zone 3 is an area which, if contaminated with a
pathogen, could lead to contamination of Zone 2 via actions of humans or movement of machinery.
Examples of Zone 3 areas include corridors and doorways leading into food production areas or
areas in a large production room that are further away from food handling equipment than typical
zone 2 areas. Walls, phones, forklifts and “mules ”, even if physically located in Zone 2, should be
considered Zone 3 due to a decreased likelihood of cross-contamination.
• Zone 4: The area immediately surrounding Zone 3, generally considered a remote area. Zone 4 is an
area which, if contaminated with a pathogen, could lead to contamination of Zone 3 via the actions of
humans or machinery. Examples of Zone 4 areas include an employee locker room if not immediately
adjacent to food production rooms, dry goods storage warehouse, finished product warehouse, cafeterias, hallways, and loading dock area.