Environmental Testing: A New Hot Button for FDA

FSMA & Environmental Monitoring
As discussed in section XII.G.1 of this document, section 418(f)(4) of the FD&C Act states that the owner, operator, or agent in charge of a facility shall verify that “the preventive controls implemented under [section 418(c) of the FD&C Act] are effectively and significantly minimizing or preventing the occurrence of identified hazards, including through the use of environmental and product testing programs and other appropriate means.’’ In addition, section 418(o)(3) indicates that preventive controls may include environmental monitoring to verify the effectiveness of pathogen controls is an example of preventive controls. The statute does not indicate the specific circumstances where environmental testing would be required or the specific manner in which such testing should be performed. Nevertheless, FDA believes that this testing can form an important component of a modern food safety system. FDA believes that the role and need for these measures varies depending on the type of products and activities of a facility. FDA further believes that the performance of environmental monitoring, for an appropriate microorganism of public health significance or for an appropriate indicator organism, is particularly useful as a verification measure for preventive controls (i.e., sanitation controls) when contamination of food with an environmental pathogen is a hazard reasonably likely to occur.

(FSMA Section XII.J.3 Request for Comment on Additional Preventive Controls and Verification Procedures Not Being Proposed)

Although it is obvious from the language of FSMA (as cited aove) that FDA supports environmental testing and monitoring, FDA did not include specific requirements to that effect in the proposed Preventive Controls Rule. It appears, from its delineation of costs to industry to conduct such testing (e.g., an estimated aggregate cost of $4 million for domestic facilities and $4.4 million for foreign facilities as noted in the rule’s appendices) that a key reason for this was the cost to industry to do so.

In fact, even though FDA suggests that current Good Manufacturing Practices (cGMPs) are not adequate to control environmental pathogens, it appears that the cost evaluation prompted the Office of Management and Budget (OMB) to remove the testing requirements before approving release of the proposed rule.

However, FDA did not simply set the issue to the side. Rather, it is requesting comment (the period for which has been extended to September 16, 2013) “on when and how environmental testing is an appropriate means of implementing the statutory directives.” FDA also requests input on the appropriate level of specificity should such provisions be included in a final rule.

Additionally, FDA identifies two sanitation processes (of product contact surfaces and to prevent cross contamination and cross contact) as potential preventive controls, for which environmental testing could be used for verification. So even without FDA requiring environmental monitoring across the board, if a facility identifies a sanitation control as necessary to address environmental pathogens as part of a preventive control program, then environmental pathogen testing is an obvious way to make sure that sanitation is being conducted in a way that addresses these pathogens.

GMPs and GFSI. It’s not just in FSMA rules that FDA is increasing its attention toward environmental testing. As shown in an article in Food and Drug Law Institute Update by Joseph Levitt (Trends From 2011 FDA Warning Letters on Adulterated Food, February 2013), warning letters are showing FDA’s trend toward focusing on the environment of the plant. “Of the more than 200 warning letters issued by FDA in 2011 regarding adulterated food, only a handful involved contamination of the food itself. ... With only one exception, all of the warning letters for foods containing a pathogen also cited environmental testing that found the pathogen in the facility.” The article goes on to state, “FDA also issued 21 warning letters for cGMP violations following positive results from environmental testing.”

Additionally, the increasing focus on GFSI in the food industry, and its relationship with many of the FSMA rules, is generating an increased focus on environmental monitoring and testing. Several of the GFSI-benchmarked audit schemes specifically call out environmental testing in their requirements. For example, BRC includes a general requirement that the plant have a “scheduled program of testing covering products and the processing environment”; and SQF requires environmental monitoring, with documentation, for high-risk foods.

There is some debate as to whether environmental testing can, itself, be considered a preventive control, as it is well recognized that every inch of a plant can’t possibly be tested—and just as you can’t test safety into a product, nor can you test safety into an environment.

However, it is clear that FDA does see environmental microbiological controls as a critical part of an overall preventive control strategy. Not only is FDA seeking comment in this area, as previously mentioned, but the appendix to the proposed rule provides substantial insight into the value FDA sees in an environmental pathogen management program, and this is consistent with the focus FDA has taken in its inspections— conducting a large amount of environmental microbiological sampling during both routine and for-cause inspections —and the warning letters being issued as a result.

A Verification Step. But whether considered a preventive control or not, environmental testing definitely can provide for verification of other preventive controls, and with the use of ATP tests or even visual inspections, it can provide rapid verification of sanitation standard operating procedures. As stated in FSMA (Section 103), “preventive controls” may include “an environmental monitoring program to verify the effectiveness of pathogen controls in processes where a food is exposed to a potential contaminant in the environment.” Thus, moving forward, food and beverage plants will want to consider how to structure an environmental monitoring program that is suitable for the facility and provides meaningful information that aids in food safety efforts.

The fact that FSMA considers environmental monitoring to have a verification role is important to remember. Environmental monitoring is about testing for pathogens or other indicators and should be used to verify that other appropriate controls, such as cGMPs and sanitation, are in place and working properly.

Using environmental testing as a verification step can be particularly important for ready-to-eat products, for which it is critical that environmental pathogens be controlled so as to not contaminate the product. Testing the production environment for environmental pathogens is, thus, not only a mechanism to verify the effectiveness of sanitation procedures, but is a signal that a corrective action may need to be implemented, or even that a product be pulled should a pathogen be found close to or on product-contact surfaces. However, testing of zone 1 areas for pathogens need to be done with the full recognition of the consequences of finding a positive and may also require some logistical planning due to the standard protocol of testing and holding.

Environmental pathogens may be introduced by raw materials, ingredients, people, pests, or objects (such as equipment or transportation vehicles). Testing for these pathogens, generally Salmonella and/or Listeria, can be used not only to verify that sanitation controls are working, but also to help refine the frequency and intensity of cleaning and sanitation. A well-designed environmental monitoring program can be used to identify hotspots, check the validity of food safety programs, and indicate trends.

Where and what to test. A complete program involves a number of steps, starting with understanding the pathogen risk in your facility and ensuring you have robust GMP and sanitation programs with documentation. But once those are in place, environmental testing can be an effective tool for verifying that these programs are working.

The best way to begin an environmental sampling program is to look at it in steps:

1. Divide the facility into areas based on risk. Develop a map of the facility, noting all rooms, equipment, and usual traffic flow, then using the industry-standard zone designation, label areas as:
   • Zone 1 - food contact surfaces. It is most critical that these surfaces are free of pathogens.
   • Zone 2 - non-food contact surfaces that are close to zone 1, such as equipment housing, exterior of equipment, etc.
   • Zone 3 - floors, drains, walls, etc. where product is being handled.
   • Zone 4 - other parts of the facility where product should not be handled or stored (locker rooms, break rooms, etc.).
      
2. Next, further divide zones 1 to 3 by indicating if they are located within raw, RTE, or storage areas.
3. Now you are ready to create a sampling plan, identifying all the potential sampling sites in the zone. The plan should include all areas of the facility, and then, taking into account the level of risk, should identify frequency and type of testing (e.g., specific pathogen, indicator organism, etc.) for each site.
4. Before implementing the sampling plan, it is critical that an action plan be specified as to what is to be done if a positive result is found (e.g., recall or destruction of product, stop production, corrective action, etc.). It is for this reason that testing for indicator organisms can serve as a useful measure of the state of a facility. If high levels of indicator organisms are found, this is a sign that sanitation and perhaps other controls are not adequate. It is important to address these issues and document the actions taken (including retesting).
5. Finally, the plant must have full documentation, not only of the findings, but also that a risk-based environmental strategy is in place and is being followed.

Whether you choose to implement environmental monitoring and testing as a preventive control, a verification step or both, it is critical that if you do implement it that it be followed and documented. FDA is looking; the focus is increasing; and from a regulatory perspective, if you did not document it, you did not do it.

Dr. David Acheson is a partner at Leavitt Partners and oversees its Food and Import Safety Practice; Jennifer McEntire is a senior director in the company’s food safety practice.