FSMA Inspection Case Study: New Natives Farm

Key Details:

Location: California Central Coast

Main Crop(s): Microgreens

FSMA PSR Inspection: 1/7/2020

3rd Party Audit(s): USDA Harmonized GAP/GMP

Certified Organic by National Organic Program: Yes

Owners: Ken and Sandra Kimes

New Natives Farm was started in 1980. Today their main crop is various types of microgreens that they grow in greenhouses and sell at Farmers Markets and to retailers around the Bay Area and across northern California. Due to their gross sales income they are required to be in full compliance with the Federal Food Safety Modernization Act’s (FSMA)  Produce Safety Rule (PSR). Farm’s that need to be in full compliance are inspected by the California Department of Food and Agriculture’s Produce Safety Program. Ken Kimes, co-owner of New Natives, participated in a PSR Inspection on January 7th, 2020. This case study shares how that experience went and some tips he has for other growers on preparing for a FSMA PSR Inspection. 

One of New Native’s co-owners, Ken Kimes, has been working on food safety related practices for their farm since 1998. Since New Natives grows one of the more “high risk” produce items (microgreens) they have been intentional about their food safety practices from the beginning. Starting around 2000 buyers started requiring New Natives to have passed a 3rd Party Food Safety Audit to be able to sell to them. What’s the difference between a 3rd Party Audit and FSMA PSR Inspection? 3rd party food safety audits are voluntary and required by buyers/industry. FSMA PSR compliance and inspections are required by law for farmers that don’t have an exemption from it. 

Ken, Sandra, and their staff figured out what they needed to do to pass an audit that first year in 2001.

One tip Ken recommends to other growers that are thinking about getting a 3rd party audit is to download the audit “scheme” (an example) then schedule an “instructional audit” where the auditor comes out to do a “practice audit” and provides feedback. This helped them be less stressed and feel prepared for their official audit. Another tip Ken shared is that it’s really helpful to have two people jointly in-charge and knowledgeable about food safety for the farm so that everything doesn’t fall on one person. And it makes it easier during audits or inspections to have another person there to answer questions. New Natives staff were familiar with 3rd party food safety audits for a number of years prior to their first FSMA PSR Inspection in 2020.

CDFA called New Natives on the phone and asked them to schedule a FSMA PSR inspection. New Native’s had that inspection in January, 2020. It took approximately 2.5 hours and involved about 1.5 hours at a desk reviewing various documents and records and then approximately an hour of walking around the farm and observing employees. An important note for farmers to know is that you can have anyone present during the inspection that you’d like. Ken had a neighbor that has experience in food safety join for the inspection to help take notes while Ken was answering questions. Additionally, prior to the inspection, Ken set up his binders of records on a couple of desks so all the documents were organized and accessible right from the start. 

Ken also shared that the first impression your farm makes on an inspector is huge. It is important for food safety that your farm be clean and organized and it also helps the inspection go smoother and be less stressful. Have whatever records you have organized and ready for the inspector. He’s also noticed that the first 20 minutes of the inspection are really important to make sure to set a good tone. Answer questions and do not provide more information than is necessary. Provide the inspector with a desk area, place to plug in a computer, and wifi (if possible). Currently there is no FSMA PSR Inspection checklist or resource provided by CDFA or FDA. He also recommends that farmers can reference the USDA Harmonized GAP Audit checklist (found on this webpage) to help prepare for the FSMA PSR Inspection. 

The CDFA Inspector asked questions related to these topics below:

  • Who is in charge of food safety?
  • Has that person completed the Produce Safety Rule required training (PSA training)?
  • Do you participate in any 3rd Party Audit programs?
  • What is the scope of the operations within the pack house?
  • What crops are being grown?
  • How do you maintain coolers, cold storage, and cooler trucks?
  • Number of fields and scope of each location?
  • Do you have contract harvest crews? If so, how is their training conducted?
  • Number of employees?
  • Do you service your restrooms or a separate company?
  • Explain details about your water source and any testing currently being done. 
  • Is postharvest water being treated? If so, with what product?
  • What soil amendments are used? 
  • What inputs are in your compost (e.g. are their animal inputs)?
  • What is happening on the adjacent land to the farm?
  • Do you have any pest pressure?
  • Employee training logs, water system assessment, visitor policy

The main item of feedback that New Natives received during the inspection was that not all of their records had the farm address and supervisor initials, which is required on some records. So they had to fix that post-inspection. At the end of the inspection the inspector writes up a Summary Report. Any non-conformances observed during the inspection are written up on a FDA Farm Form 40-56. This form is subject to Freedom of Information Act requests. Overall, New Natives felt that the inspection was done in a way that was educational and reasonable. As of the publication of this document New Natives has gone through one FSMA PSR Inspection. 

Ken’s top four tips for preparing for a FSMA PSR Inspection are:

  1. If you’d feel more comfortable with other people present with you during the inspection, make sure to invite them to be there and supporting you how you’d like (e.g. taking notes).
  2. Compile as many records as possible in one location with a desk, access to power, and a space where you and the inspector can go over the records part of the inspection.
  3. Make sure your farm makes a good “first impression” – have things be as clean and organized as possible. 
  4. Let the inspector drive the inspection, listen carefully and do not over answer the questions. The inspector has to take notes on observations and what was discussed. If you volunteer derivative information it will only prolong the audit/inspection.

Hopefully this case study has helped you feel more comfortable preparing for your FSMA PSR Inspection.

Has your farm gone through a FSMA PSR Inspection? If so, please email Kali (kali@caff.org) to share your experience and be featured in a case study! 

This material is based upon work that is supported by the National Institute of Food and Agriculture, U.S. Department of Agriculture, under award number USDA-NIFA-FSMA-2020-70020-32266.