As we continue our analysis and review of the rules, our focus this week is on environmental monitoring. As expected, FDA is developing guidance on environmental monitoring, but until then, it is helpful to understand the key points of the provisions and what you will be required to do.
The simplest explanation of the requirements for environmental monitoring come straight from the rule: This final regulation requires domestic and foreign facilities to “institute risk-based environmental monitoring … as appropriate to the food, the facility, and the nature of the preventive controls.” This statement is repeated in various ways throughout the rule, particularly in FDA responses to comments.
To go into more detail of what that means and what you need to be doing, the rules, first and foremost, require that you establish and implement written procedures for environmental monitoring, which must:
- Be scientifically valid.
- Identify the test microorganism(s).
- Identify the locations from which the samples will be collected and the number of sites to be tested during routine environmental monitoring.
- Identify the timing and frequency for collecting and testing samples.
- Identify the test(s) conducted, including the analytical method(s) used.
- Identify the laboratory conducting the testing.
- Include the corrective action procedures [required by § 117.150(a)(1)].
- Document implementation of the food safety plan records as relates to verification of environmental monitoring.
- Provide for reanalysis of the food safety plan as a whole at least every 3 years, and reanalysis of the plan or any applicable preventive control, if new information is available.