Written by Anila Mehmood
As of April 2019, routine Produce Safety Rule inspections started on large farms, by CDFA if you are in California. Are you Ready? Before inspections began, On-Farm Readiness Reviews (OFRR) were being conducted to make sure that each farm was ready for their inspection. The data shows that while 9 % of farms need significant adjustments, only 39% of farms that were visited demonstrated full compliance, and 52% of farms needed minor adjustments. This article is meant to be a resource to help you understand the FDA fact sheet ‘What to Expect of a Regulatory Inspection’ for farmers and make recommendations for how you can effectively prepare for your produce safety rule inspection.
Industry Insight
While at Safe Food California 2019 conference, Steve Patton, Chief of the Compliance Branch for the CDFA Produce Safety program spoke on the Produce Safety Rule. Steve explained what to expect in 2019, including the inspection start date of April 8th and areas of concern for farmers.
The six areas that need improvement are:
- Informing visitors of food safety policies
- Keeping record of biological soil amendments
- Assessing risk for animal intrusion
- Following up with corrective actions
- Keeping records of cleaning and sanitizing
- Employee health and hygiene
Pre-Inspection
If you are a farmer in California and are not exempt you will receive a pre-inspection call. The initial produce safety rule inspection is typically announced and scheduled within five business days of the initial call. Inspections will be coordinated to work for both the inspector and farmer. These inspections will be scheduled when farm activities are taking place.
In February 2019, CDFA mailed out a survey to farms throughout the state If you did not receive the form, CDFA is encouraging all farms in California to complete this form (click here to complete survey). These survey results are used to determine how farms will be prioritized for inspection.
If the farm is exempt (qualified or commercial processing exemption) from the produce safety rule, the inspector will review records to verify the exemption.
Note * Although most inspections will be announced, unannounced inspections will occur if the farm has had previous food safety issues (if the farm has been unresponsive/unwilling, if there is a complaint, recall or foodborne outbreak investigation linked to the farm).
Recommendations for the farm:
- Monitor calls, voicemails, and emails regularly to avoid an unannounced audit. If the farm is unresponsive for five business days after the initial call, an unannounced audit may be scheduled. A majority of the time the inspector will call the farm owner, or responsible party.
- Subscribe to the FDA FSMA Rule updates and the Produce Safety Alliance so that you receive updates on any updates (recalls, rule updates/changes, additional guidance documents).
- When scheduling the audit, include the field supervisor or responsible representative that is knowledgeable on the farms activities/produce safety.
- Notify the inspector if you have specific safety protocols or practices they need to be aware of before the audit.
Produce Safety Rule Inspection Day
So you have your inspection scheduled but what now?
The initial interview will take place on the farm or a nearby location and will last no longer than one day. A nearby location may be set up if the farm location is not easily accessible. The inspector will present their credentials/identification, state the reason for inspection (may include written letter of inspection or similar documentation), review what will be inspected, and how the inspection will take place. The owner or responsible party should be present for the entire inspection.
The inspector will also discuss the farming activities that will take place during the inspection and what records they will be reviewing. According to Steve Patton, initial inspections will not focus on enforcement actions, instead the objective is to ‘Educate while regulating’. The main goal of the Produce Safety rule is to emphasize public health so inspections will be educational in nature unless there is a major non-conformity or public health threat.
Recommendations:
- Plan to have a representative from your farm that is knowledgeable on all produce safety activities including growing, harvesting, packing and holding activities.
- Be prepared to ensure an efficient inspection. Know the farm processes (ex: planting, harvesting, packing or holding of produce).
- If you have a map of the farm, make it available to the inspector. Kevin Gerrity, FDA National Food Expert encourages inspectors to request a map of the farm. If a map is not available, the inspector will draw out a diagram to include fields, water distribution systems, sanitary facilities, storage buildings, and other structures on the farm.
The inspector will walk or drive the farm perimeter (including storage and other infrastructure such as private property on farm) to identify any possible roots or sources of contamination on produce. They will explain all observations being noted, and will explain areas of concern. The inspector will also ask questions and review records throughout the inspection of on farm activities and practices, especially if they cannot be observed. They may also take pictures, collect samples, and copy records.
Recommendations for on-farm inspection:
- Check run off routes, structures around the farm that can harbor pests, evaluate drains, and any wildlife activity.
- Review training materials from the Produce Safety Grower training course and utilize checklists and record keeping templates provided.
- Ask questions during interview to understand any observations noted.
- Have records readily available (visitor logs,
water testing, cleaning and sanitizing schedule, biological soil amendments of
animal origin, and training records-including the PSA Grower training course
certificate).
- Verify all records and ensure each record includes a name, location of farm and growing area(s), description of covered produce, date and time of activity documented (should be created during the time of activity/observation) and a signature/initial.
End of Inspection
The inspection is over. You did it!
At the end of the inspection, the inspector will recap observations made throughout the inspection. No new observations will be reviewed at this time; it will be an overall review of the inspection. All immediate corrective actions will be documented on-site. If a corrective action or preventive measure is not able to be implemented during the time of inspection, the inspector will work with the farm to set up a time frame to make the correction(s). Depending on the observations and conditions of the farm, a follow up/routine inspection may be required. With the ‘Educate while regulating’ approach, the inspector will provide additional resources and technical assistance. At the end of the exit interview, the farm will receive a report that will document the inspection has taken place (FDA Form 4056). Two weeks after the inspection an additional summary report with details and corrective actions will be emailed.
Recommendations:
- Review the inspector form (FDA’s From 4056: Produce Farm Inspection Observations) before the inspection. This form will be used by the inspector to provide the farm with feedback and document observations. This can be used as a check list when reviewing the farm’s good agricultural practices.
- Have the responsible parties from the farm (owner, manager, or field supervisor) at the exit interview, especially if they were a part of the walk through. This is a good opportunity to ask any follow up questions.
- Work with a third party consultant or auditor to implement corrective actions/preventive measures before the due date. If the required corrective actions or preventive measures are not implemented, the farm may receive an unannounced audit.
Still have questions about the Produce Safety Rule? As the Produce Safety Rule Grant Recipient, Safe Food Alliance is ready to help you get to where your food safety knowledge needs to be. For more information please call (916-561-5900 ext.103) or email me at anilam@safefoodalliance.com.
Helpful Resources
FDA Website: https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM630765.pdf
YouTube:
Produce Safety Alliance:
https://producesafetyalliance.cornell.edu/training/grower-training-courses/upcoming-grower-trainings
