Microbiological Food Safety

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		Microbiological Food Safety Task Force
		
	

		FOOD RELATED CONTAMINANTS
	
	
This guidance contains a set of approaches to evaluate available data on target pathogens to support the use of validation studies.
In order to ensure safety of food, a number of control measures need to be implemented by the industry. Validation studies are used to provide evidence that the implemented measures are actually capable of controlling the identified hazard.
Potential to limit the occurrence of discrepancies in the information.
By utilising this guidance, actors involved can identify product and process factors that are essential when designing a validation study. They can thus, select the criteria for identifying an appropriate target pathogen or surrogate organism for a food product and process validation.
Designed for a wide range of food-production professionals.
The document helps food manufacturers, processors, and food safety professionals to better understand, plan, and perform validation studies. It offers an overview of the choices and key technical elements of a validation plan, the necessary preparations including assembling the validation team and establishing prerequisite programs, and the elements of a validation report.
				

		Decision tree to support the decision of when and which validation study approach is most applicable
	
	
There is a great interest in the food industry to perform validations in a manner that would be accepted by all parties involved, for example, authorities and customers.
	
To download this open-access article, please click here.
			Scientific abstract 
							Expand
		
Food manufacturers are required to obtain scientific and technical evidence that a control measure or combination of control measures is capable of reducing a significant hazard to an acceptable level that does not pose a public health risk under normal conditions of distribution and storage. A validation study provides evidence that a control measure is capable of controlling the identified hazard under a worst-case scenario for process and product parameters tested. It also defines the critical parameters that must be controlled, monitored, and verified during processing. This review document is intended as guidance for the food industry to support appropriate validation studies, and aims to limit methodological discrepancies in validation studies that can occur among food safety professionals, consultants, and third-party laboratories. The document describes product and process factors that are essential when designing a validation study, and gives selection criteria for identifying an appropriate target pathogen or surrogate organism for a food product and process validation. Guidance is provided for approaches to evaluate available microbiological data for the target pathogen or surrogate organism in the product type of interest that can serve as part of the weight of evidence to support a validation study. The document intends to help food manufacturers, processors, and food safety professionals to better understand, plan, and perform validation studies by offering an overview of the choices and key technical elements of a validation plan, the necessary preparations including assembling the validation team and establishing prerequisite programs, and the elements of a validation report.
			Keywords
							Expand
		
critical control points, inactivation, pathogen, preventive control, process validation
					Range of nonthermal processing techniques in this study:
		10
					+ the critical parameters for their application and examples. 
					Key factors to consider related to the product
		8
					They are used to determine process efficiency and whether the target pathogen is capable of growth in product.
					Food categories for which examples of common pathogens of concern are given
		19
					 + the situations posing increased risk.
	
Validation studies are necessary even when safe harbors are available to ensure correct implementation of control measures.


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		Microbiological Food Safety Task Force
		
	

		FOOD RELATED CONTAMINANTS
	
	
Prevalence of pathogens of concerns for Low Moisture Foods (LMF) is considered through investigation of the reported foodborne outbreaks.
A Processing Environment Monitory programme (PEM) needs to be in place in order to identify points which need to be routinely sampled, search for harbourage niches, and detect and destroy pathogens of concern. These programmes need to be specifically designed considering the specific pathogens and production set up.
However, a monitoring programme on its own is not sufficient and needs to be accompanied by corrective and preventive action plans to ensure efficient application of the Good Hygiene Practices.
A tool for both food producers and regulators
This guidance document is intended to help set up targeted processing environment monitoring programs depending on their purpose, and therefore provide the essential elements needed to improve food safety.
Several food pathogens are of significant concern when planning monitoring programmes for LMF, and are discussed in this document:

Salmonella, 
Cronobacter spp. (posing risk to infants), 
pathogenic E. coli, 
B cereus
Listeria monocytogenes.

				
	
Overview of recalls, withdrawals and safety alerts with microbial pathogens in the EU and US in 2012-2017. EU data were extracted from RASFF (2020) and US data were extracted from FDA (2020).
	
There is a great interest in the food industry to perform validations in a manner that would be accepted by all parties involved, for example, authorities and customers.
	
Low moisture foods are foods that:

are naturally very low in moisture,
have had water removed from them,
have a higher moisture content, but that contain agents that prevent the moisture from being available to microorganisms to allow their growth.

In this work, the "production environment" includes production equipment, production surfaces, floors/walls/ceilings, and the air within the production area.
	
Link to download the full-text
			Scientific abstract 
							Expand
		
Processing environment monitoring is gaining increasing importance in the context of food safety management plans/HACCP programs, since past outbreaks have shown the relevance of the environment as contamination pathway, therefore requiring to ensure the safety of products. However, there are still many open questions and a lack of clarity on how to set up a meaningful program, which would provide early warnings of potential product contamination. Therefore, the current paper aims to summarize and evaluate existing scientific information on outbreaks, relevant pathogens in low moisture foods, and knowledge on indicators, including their contribution to a "clean" environment capable of limiting the spread of pathogens in dry production environments. This paper also outlines the essential elements of a processing environment monitoring program thereby supporting the design and implementation of better programs focusing on the relevant microorganisms. This guidance document is intended to help industry and regulators focus and set up targeted processing environment monitoring programs depending on their purpose, and therefore provide the essential elements needed to improve food safety.
			Keywords
							Expand
		
critical control points, pathogen, preventive control, recontamination, Bacillus cereus, Listeria monocytogenes, Salmonella spp., Cronobacter spp., Enterobacteriaceae, dry foods, food safety, processing, environment Monitoring
					 Low Moisture Foods are defined as having a water activity of
		1
					or below.
					In the EU and USA there were
		498
					combined alerts for microbial pathogens and LMF.
					Between 2010 and 2017, EFSA reported
		10
					salmonellosis outbreaks from LMF alone.
	
Genetic characterization of isolates provides interesting insights for understanding the difference between resident and sporadic strains in a processing environment.


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