This interview is part of our Food Safety Modernization Act (FSMA) case study series. In earlier case studies we interviewed other farmers and they talked about food safety practices they complete to minimize their food safety risks and be in compliance with the FSMA Produce Safety Rule (PSR). This “case study,” takes a different approach in that we were able to interview one of the California Department of Food and Agriculture (CDFA) Produce Safety Program’s FSMA Inspectors, Sarah Standiford. Please read through this interview to learn more about how your farm can prepare for a FSMA PSR Inspection and feel less stressed about it all!
Meet Sarah Standiford! She is currently a Supervisory Environmental Scientist in CDFA’s Produce Safety Program. Previously she was a FSMA PSR Inspector in the program. She virtually sat down with CAFF’s Farmer Services Director, Kali Feiereisel, to answer the FSMA PSR Inspection questions below. The interview covers three main sections: 1) Background Information, 2) A Day in the Life of a PSR Inspector, and 3) Tips for Farmers Preparing for FSMA Inspections. Please read on to learn more.
What is the CDFA Produce Safety Program?
The California Department of Food and Agriculture (CDFA) Produce Safety Program (PSP) is a unit operating under CDFA’s Inspection Services Division (ISD). PSP’s goal is to ensure that California produce farmers understand how to comply with the requirements of the U.S. Food and Drug Administration (FDA) Produce Safety Rule (PSR) under the federal Food Safety Modernization Act (FSMA). PSP, on behalf of FDA, conducts regulatory inspections on farms with more than $25,000 in average annual sales of covered fresh produce (averaged over previous three years) to ensure farms are compliant with the PSR.
When was it created?
FSMA was passed into law in 2011. The CDFA PSP was formed in 2016 and in 2019 PSP began conducting on-farm inspections in California to verify compliance with the PSR.
Congress enacted FSMA in response to dramatic changes in the global food system and in our understanding of foodborne illness and its consequences, including the realization that preventable foodborne illness is both a significant public health problem and a threat to the economic well-being of the food system. FSMA has a strong focus on educating and understanding of food safety risks and risk mitigation.
There were multiple outbreaks of foodborne illnesses that occurred in the mid-2000s that affected many people and resulted in several deaths. Notably, there were outbreaks linked to California-grown spinach (E. coli) in 2006, and tomatoes and peanut butter products (Salmonella) in 2008. There emerged a need for the food industry to focus on how these incidents occurred, figuring out the reasons behind them, and how they could be prevented in the future.
How many CDFA FSMA PSR Inspectors are there in California currently? How many are there planned to be?
A current list of CDFA FSMA PSR inspectors is available on the CDFA website at: https://www.cdfa.ca.gov/producesafety/regulate.html (Click “Meet the Regional Produce Safety Inspectors”). PSP aims to have a team of 10 inspectors this year.
Why does CDFA complete FSMA PSR Inspections in California and not the FDA?
FDA initiated a partnership with state and territory agencies in 2016 via the Cooperative Agreement Program (CAP); current agreements are through year 2026. CAP provides technical and financial assistance to state and territorial agencies to develop and implement multi-faceted Produce Safety Programs that support implementation of the Produce Safety Rule and the FDA Food Safety Modernization Act (FSMA). A large majority of the states under the CAP fall under Path B (jurisdictions that conduct produce safety inspections under FDA’s authority) and Path C (jurisdictions that will conduct produce safety inspections under their own authority). There are very few states (Path A or not part of CAP) where FDA conducts inspections directly.
California is a Path B state, with CDFA identified as the agency to conduct produce safety inspections under FDA authority. PSP staff undergo the same training and credentialing process as a directly hired FDA employee. PSP employees carry an FDA-issued badge and complete paperwork required by FDA during and after inspections. This partnership brings together CDFA’s mission of serving citizens of California by promoting and protecting a safe, healthy food supply, and FDA’s approach to implementing FSMA, i.e., “educate before and while we regulate.” By maintaining the safety of the fresh produce grown in California, this partnership plays a critical part in promoting California agriculture, helping educate growers about food safety, and protecting public health against preventable foodborne illnesses.
If a farm hasn’t been inspected yet, but they are covered under FSMA, can you provide a timeline or an approximate timeline on when they could expect to hear about an inspection?
PSP has a goal to verify the covered status on 20,000+ produce farms in California and subsequently conduct on-farm inspections in the next 3-5 years. PSP staff contact farms through various methods, such as letters, emails and phone calls. Typically, the scheduling of routine inspections occurs as a result of discussion with farmers, based on their availability and schedule of ongoing farm activities such as growing and harvest of specific fresh produce commodities.
Have you reached out to any farms that are qualified exempt under FSMA? If so, what can farmers that fall into this category do to be prepared for CDFA’s Produce Safety Program?
Typically, the qualified exempt status of a farm is determined during our initial contact call made to verify farm status. This call includes general questions about business operations to help us determine covered or exempt status. Instances where a farm may be eligible for exemption from the PSR include but are not limited to $25,000 or less in annual produce sales and growing commodities that are identified by FDA as “rarely consumed raw.” Detailed information regarding exemptions is available on the FDA webpage: https://www.fda.gov/media/94332/download. A farm may be asked to show records required to be kept and formatted in specific ways to help properly identify the farm and/or support an exemption claim made during a verification call.
A Day in the Life of a PSR Inspector
What drew you to becoming an inspector for CDFA’s Produce Safety Program (PSP)?
I have a background in food safety and educating companies on the importance of their food safety culture. The mission of the PSP is to educate before, during, and while we regulate – the education and regulation component is key. It’s important to build the relationship with growers and explain how growers can positively impact food safety with the practices they choose. I learn something new every day in this industry. Our state is so diverse and we grow so many different crops.
What does the typical day of a CDFA PSP Inspector look like?
Every day is different! Each inspector has a region of the state (learn more on this webpage, under “Meet the Regional Produce Safety Inspectors”) that they are based out of. The majority of their inspections will be based in that area. The inspector will make phone calls to the growers and ask a few questions to determine if the grower is subject to the FSMA PSR. Both parties agree on a time for inspection. While inspectors are based in a particular region, California is a large state, and there are times inspectors need to travel overnight to cover inspections in their region or an adjoining region. When inspectors are not in the field they’re writing inspection reports, attending trainings, and conducting team debriefing sessions to enhance learning opportunities and consistency of inspections among the team.
Approximately how many farms do inspectors inspect in a week?
Inspectors aim to conduct 2-3 inspections per week. Each inspection is physically at the location where activities covered by the PSR – including growing, harvesting and packing – take place. The remaining time in an inspector’s week is used for traveling and writing up reports.
Are inspectors often working by themselves or with other colleagues?
Inspections are normally performed by one inspector, but it’s possible that two inspectors may perform an inspection together. We have a robust training program where a new inspector shadows a seasoned inspector; then they switch roles. Following this, a supervisor observes an inspector before they are cleared to go out and do inspections on their own. Often times the grower (during an inspection) will have support personnel with them (e.g., a consultant they work with). There have been scenarios where two inspectors may be paired together for large farms.
Do you have anything else you’d like to share?
It’s important to note that inspectors are available before and after the inspection to help answer any questions. One of the goals of the program is to build relationships with the growers in their region.
Tips for Farmers Preparing for FSMA PSR Inspections
How can a farmer expect to be contacted and schedule a FSMA Inspection?
The CDFA Inspectors usually contact a farm by phone. If we happen to have an email address on file, they may contact them through email as well. Sometimes a farmer that they talk to on the phone will also request CDFA email information to help prove legitimacy. The growers sometimes request a written letter, as well, and CDFA can provide written assurance, if necessary. The grower will be asked questions to determine if they are covered under the Produce Safety Rule (to make sure they don’t qualify for one of the law exemptions). If the grower is covered, then usually the inspector schedules an On-Farm Readiness Review (OFRR) or an inspection during that phone call depending on the preference of the farm.
If a farmer’s primary language is not English, does CDFA provide a translator/interpreter or is that something the farmer needs to arrange?
There are multiple bilingual Spanish/English Inspectors. If an English inspector connects with a Spanish speaking farmer, then that conversation is redirected to a bilingual inspector. We have had other situations where a farmer can understand enough and then they work with other family members to translate/interpret during an inspection. CDFA also has a technical assistance program funded by the state budget with UC extension. Those assistance providers are able to provide assistance in additional languages.
Can you describe the general process you go through during a FSMA PSR Inspection?
When we are scheduling the inspection with the farmer, we ask them what time of day works best and also what activities are being conducted on the day of the inspection. Sometimes inspections have started at 5:00 AM, whereas other farmers need inspections to be in the afternoon or even overnight if crops are harvested in the evening. CDFA wants to be able to observe as many activities as possible. The timing of paperwork review during the inspection is usually agreed upon between the grower and inspector at the start. Sometimes there’s a need to look at additional paperwork as an inspection progresses. In general, there will be two main parts of the inspection: 1) paperwork review and 2) observing covered produce activities.
As you’ve visited farms, what would you say are the best things farmers have done to prepare for a FSMA inspection?
One thing that helps an inspection go smoother and take less time is when the grower has all the paperwork prepared and ready to review. Farmers that have done an On-Farm Readiness Review and/or a 3rd party audit generally are very prepared. Once the inspection is scheduled CDFA sends the grower five links of documents that help the grower prepare for what records will be asked about so they can have them ready. Inspectors are aware that sometimes they have to wait while a grower finds a record. CDFA Inspectors know that a farmer’s time is valuable and do their very best to be prepared on their end so that farmers are not waiting for the inspector in any way.
If harvesting is going on, CDFA tries to assess the grower during real time to understand day-to-day operations. CDFA inspectors try their best to work with growers’ schedules and planned activities for the day of inspection.
What are the top two most important things a farmer can do to prepare for their inspection?
- Take the Produce Safety Alliance Grower (PSA) training. This training (or an equivalent one) is required under the Produce Safety Rule.
- If possible, have the Produce Safety Program conduct an On-Farm Readiness Review (OFRR) prior to an inspection. Farms can learn more and sign up for an OFRR on this webpage.
During a FSMA inspection, what are the top 3 areas you see farmers should have focused on more?
We are still learning from inspections and will have more insights on this in the future. As of now, these are the top three areas we recommend:
- Farmers engage with PSP staff to help determine if their farm is covered under the PSR
- Farmers engage in a PSA Grower Training and take advantage of the On-Farm Readiness Review as it helps serve as a practice/preparation toward a regulatory PSR inspection.
- Farmers maintain documentation of their food safety trainings, sanitation records, etc.
Do inspectors talk to employees during an inspection?
Inspectors do talk to employees during an inspection. When this occurs, CDFA Inspectors really try to make the employee feel comfortable and have the farm owner/representative present. At times the farm owner might not know the specific details that an employee might know.
Can you speak more about CDFA’s approach to FSMA Inspections as “educate then regulate?”
We try to make the inspections conversational. Some growers may take time to get used to that approach, where we are trying to learn about their business and the specific practices on their farm. The inspectors are learning about farming/what’s happening on the farm at the same time they’re asking growers questions related to the Produce Safety Rule. The first inspection with a grower is educational. The inspector discusses what they saw during the inspection with the grower and issues a form, called FDA 4056, to the grower at the time of inspection. The grower also receives a detailed final inspection report from CDFA after a few weeks. Unless the inspector observes something egregious (e.g., a porta potty is knocked over in a field and people are harvesting next to it), observations are documented in the farm’s final report. Once a farm is on its second inspection and beyond, CDFA officially documents observations and reports these to FDA via the FDA 4056 form.
Do you have anything else to share on how farmers can prepare for a FSMA PSR Inspection?
CDFA really values the soft skills in their inspectors and we understand that growers’ farms are their livelihoods. CDFA PSP is here to help farms feel comfortable with the FSMA produce safety requirements and to foster compliance with the PSR. It’s a shared responsibility between growers, inspectors, and farm employees – we all need to work together to keep our food safe.