Tip of the Week: The Extent and Scope of Product Testing and Environmental Monitoring

Building on our FSMA tip of the week series, let's take a look at verification activities as they relate to environmental and product testing. Pending the release of guidance documents from the FDA on this subject, we know that environmental hazard analysis is required if your product is considered to be ready-to-eat (RTE), which includes raw and processed foods that do not have formulation controls to significantly minimize pathogens. Your site hazard evaluation for environmental pathogens will dictate the rigor of your environmental and product testing of both raw materials and finished product to verify that existing preventive controls are effective.

Listeria monocytogenes

Listeria monocytogenes

By definition in the rule, an environmental pathogen is a pathogen capable of surviving and persisting within the manufacturing, processing, packing, or holding environment such that food may be contaminated and may result in foodborne illness. This means the scope could be your entire facility. For environmental pathogens the rule specifically cites Listeria monocytogenes and Salmonella spp. and excludes spore-forming pathogenic bacteria. Under subpart 117.130 (2) the environmental evaluation must consider the following as it affects food safety for the intended consumer:

  • Formulation of the food
  • Condition, function, and design of the facility and equipment
  • Raw materials and other ingredients
  • Transportation practices
  • Manufacturing/processing procedures
  • Packaging and labeling activities
  • Storage and distribution
  • Intended or reasonably foreseeable use
  • Sanitation, including employee hygiene
  • Temporal (e.g. weather-related) that can affect the nature of some hazards (e.g. level or toxins)

Any preventive controls identified in your hazard evaluation need appropriate verification activities. This includes product and environmental testing to verify effectiveness of those controls for pathogens or appropriate indicator organisms in raw materials; environmental swabs of equipment/facility, packaging, and storage areas; sanitation; and employee hygiene. The true intent and scope of your testing is to prove you know where your potential or actual food safety issues are and then demonstrate through records and plant conditions that your preventive controls are effective. If areas of weakness, ineffective implementation, or previously unidentified food safety hazards are encountered, then you will need to reanalyze those situations and perform corrective action to prevent recurrence.

Environmental monitoring and product testing verification activities provide valuable information about what plant conditions and materials could or will allow product contamination so that rigorous self-correcting verification activities can be applied to maintain and improve your food safety plans. The ultimate goal is to prove that your company is operating in a food-safe mode so that if food safety is compromised, appropriate decisions are made to prevent unsafe food from entering commerce. 

Coming up next week, we'll discuss supply chain program setup and management.

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