Getting Candid about Environmental Monitoring Programs

This also assumes that the company has a hold-and-release program in place. The dilemma some industries face (produce for example), is the shelf life of the product dictates that almost immediately after packaging the product is into distribution—often before results are available. The response to that situation is the company should have a well-founded, extensive sanitation program, environmental monitoring program (EMP), and one heck of a Work in Process testing program with rapid methods that are: 1) reliable, 2) recognized reliable and applicable to your matrix, and 3) being used effectively to provide the warnings before the product gets out of the control of the company.

FDA has always taken the following approach: You cannot test enough samples to prove the product is not contaminated or test your way out of a problem. This is basically why most companies do not test for the pathogen but rather test for an indicator that does not incriminate the product. Keep in mind that by not testing Zone 1 sites, it doesn’t mean the product does not represent a potential health hazard in the marketplace. Should that product be associated with an illness outbreak, there are severe consequences to:

• Failing to keep the product safe;
• Having a paper trail that indicates you knew, or should have known, there were potential issues associated with the finished product based on the Zone 1 swab result, or lack thereof; and
• Testing the product, finding nothing in the few samples you tested, and assuming that the rest of the “untested” production was acceptable.

Finding a positive environmental swab result, regardless of the Zone, still requires the offending area be cleaned and that subsequent swabs are negative. I will also add that if the remedial actions and result aren’t documented, then you didn’t do them.

The Food Safety Modernization Act (FSMA) has expanded the swab zone to be a 12-inch-by-12-inch area. The increase in size represents an increased potential of finding a positive, and that is exactly the point of any well-designed environmental program. John Butts, PhD, one of the foremost authorities on Listeria and environmental sampling, preaches the Seek and Destroy mission, which is the fundamental foundation of every environmental swab program. Seek out the niche places that harbor the offending microorganisms and adjust the sanitation programs and environmental surveillance to destroy that harborage. FDA expects:

• A positive environmental swab to be attacked and eliminated;
• Negative results for a minimum of three consecutive swabs be conducted on separate dates;
• That the once-positive site be monitored and continually swabbed for at least six months; and
• Documentation, documentation, documentation!

Positive environmental swab results are telling you something, and you need to listen. A positive result in a drain that is cross connected to other drains tells you all the drains are potentially positive, and cleaning that one single positive in no way ensures you’ve eliminated the source of the problem. Establish the fact that you have a drain cleaning program and use things like quaternary-containing socks or appropriate biocides throughout the production day to minimize the chances that aerosolization of the drain water is not allowing pathogens to become airborne. Having a intermittently positive drain may also indicate that your cast iron drain pipe is harboring a biofilm and continuing to put chlorine and other harsh chemicals down the drain in an attempt to eliminate the problem is actually making it worse.

The corrective action to consider is to isolate the entire drain area with floor-to-ceiling polyethylene and sandblast the corrosion off the inside of the drain. Once the drain is again smooth, a metal epoxy coat should be applied to the inside of the drain to prevent further rust development and/or pitting. Consider inserting a cleanable, stainless steel insert that extends significantly down into the drains.