Pathogen testing in food manufacturing plant

I have a two part question for a Bakery type facility that makes both RTE baked goods and frozen products.

1-Environmental monitoring program.  We are currently ramping up our program with ATP swabs and indicator (APC, Yeast/Mold) testing.  With the new FSMA requirements, do you feel as though we are required to perform pathogen testing throughout the facility? 

2-If required, we are considering performing the pathogen testing in house.  Are there any specific things that we definitely need to do with creating an in-house lab that will allow us to perform this testing and meet SQF compliance?

Hi msfs,

I'm not in USA but I I thought US manufacturing facilities were not legally allowed to do pathogen testing in-house ?

You actually just described the facility that I work in to a tee, as we make RTE and Frozen products.

As for your first question, this is from the FSMA FAQ from the FDA:

"The preventive controls final rules require that a facility verify that hazards are being controlled and take corrective action to prevent contamination; and product testing and environmental monitoring are examples of steps a firm may take. A facility’s decision to conduct product testing, and to establish the frequency of such testing, will reflect a risk-based approach consistent with its hazard analysis. Consequently, the FDA expects that facilities that produce foods that have frequently been associated with outbreaks of foodborne illness or pathogen contamination, or produce ready-to-eat foods for which an effective preventive control cannot be implemented, would establish product testing programs more often than facilities that do not produce such foods."

"Similarly, a facility that identifies an environmental pathogen as a hazard requiring a preventive control, for example, sanitation controls, would conduct environmental monitoring. Such a facility would decide what, if any, role product testing would play as a verification activity or as part of a corrective action as a result of positive findings from environmental monitoring, based on the facility, the food, the nature of the preventive control, and the role of the preventive control in the facility’s food safety system. "

Given the language used here, I would say that Environmental Monitoring throughout the production and storage areas of the facility is necessary.  The frequency of the swabs should be determined based on a solid risk analysis of each area.

I'm afraid that I can't be terribly helpful for your second question.  We contract our microbial testing to an outside lab.  I do know of a handful of facilities that have a microbiological lab on-site, but the lab tends to be in a separate building than the production floor (aka, still on 'factory' grounds, but in a separate structure).  That said, I know of one lab where it is in the same building as production.

I don't know about the US legislation but certainly in the UK the requirements of on site pathogen labs are so onerous as to not make them financially viable.  I would think that contract labs would always be able to do this cheaper, especially if you only have a small number of samples.

FSMA verbiage cites preventive controls may include sanitation procedures, environmental monitoring of pathogen controls, allergen control and current Good Manufacturing Practices (cGMPs), among others. Within the Hazard Analysis and Risk-Based Preventive Controls section of the rules, FSMA states the facility will be responsible for monitoring the effectiveness of the aforementioned preventive controls to verify that the controls are adequately addressing identified hazards. Objectively assessing the hazards in the processing environment is a prudent. A robust food safety environmental monitoring program typically includes ATP sanitation monitoring, protein surface testing (allergen screening), environmental allergen test kits and microorganism testing. I know Hygiena offer Listeria and Salmonella test swabs that are self contained to eliminates risk of contamination.

http://www.hygiena.c...od-service.html

Hope that helps.

I'm with GMO on the second part. You REALLY don't want to build your own path lab. For a start, you will need to perform daily validations with samples of live bacteria which you will hold on site. It's possible, but not worth the effort and additional risk when external labs are both fast and low cost.