FSIS implementation of validation requirements
FSIS will soon verify that establishments are in compliance with all HACCP validation regulatory requirements.
According to FSIS, there are two elements of validation:
- Scientific support and
- In-plant validation.
Until now, FSIS only has been verifying establishment compliance with the first element — whether the establishment has scientific support for the design of its HACCP plan. After January 4, 2016, at large plants — and April 4, 2016, at small and very small plants — FSIS will begin verifying the second element: that the establishment has in-plant data to demonstrate the HACCP plan is working effectively at that establishment.
Training — FSIS is in the process of developing training and instructions for its field personnel on how to conduct the verification activities. An initial training video (which is available on YouTube) was announced in FSIS Notice 66-15. FSIS expects to issue more formal instructions (Notice or Directive) before the implementation dates.
Inspection Program Personnel (IPP) Verification — At this time, the IPP are to continue to ascertain whether establishment has scientific support for its HACCP plan when conducting a Hazard Analysis Verification (HAV) task pursuant to Directive 5,000.6. After the above effective dates, the IPP will also verify, as part of the HAV task, whether the establishment has in-plant data to support that the HACCP plan is operating as intended. Non-compliance is to be documented with a non-compliance report (NR). If the IPP have questions as to whether the establishment validation comports with the regulations, the IPP are to request review by an EIAO.
EIAO Verification — The EIAOs also will review validation during Food Safety Assessments pursuant to Directive 5,100.1 or in response to a request from the IPP. The EIAO review will be more detailed than the IPP’s.
Initial Validation Data — FSIS will ask for the initial HACCP validation data. The validation regulation, 9 CFR § 417.4 (a)(1), requires establishments to conduct an initial validation of the HACCP plan. In an initial validation, the establishment is to conduct repeated testing of HACCP plan to demonstrate the plan is functioning as intended. If the plant no longer has the initial data, the establishment should review its last 90 calendar days of data, including monitoring/verification checks, microbial testing and other supporting data, to be able to demonstrate that the HACCP plan is indeed operating as intended.
Enforcement — FSIS has indicated a Notice of Intended Enforcement (NOIE) will be issued for validation concerns only when supported by the Rules of Practice (9 CFR Part 500), such as when an insanitary condition exists. Please note, FSIS will deem a failure to comply with a validation requirement, such as lack of scientific support or in-plant data on an intervention, as creating an insanitary condition. Put another way, an NOIE for insanitary conditions can be expected if the establishment does not meet the validation requirements.
Given the upcoming verification activities, a prudent establishment would review its validation support so that it will meet the regulatory requirements by the effective dates.
FSIS expressly delayed implementation of its verification activities to provide establishments with the opportunity to review the last 90 calendar days of data to validate the HACCP plan is working as intended. This would include establishment review of the critical operational parameters in the scientific support to ensure the support is consistent with the plant’s actual process. The establishment should also demonstrate that these critical operational parameters are being monitored and verified. As part of this review, the establishment should review equipment calibration data, especially calibration relating to a critical operational parameter in the scientific support.
Depending on the amount of data an establishment has generated already in connection with operating under the HACCP plan (this could include microbial sample results, consumer complaints, audits, inspection findings, etc.), the establishment may need to increase the frequency of its monitoring and on-going verification activities during the 90-day period to demonstrate that the process is being executed effectively.
The agency has been discussing verification of establishment validation for several years and has postponed implementation to provide establishments time to prepare. By the effective dates, establishments should be ready. NP