Learn more about a
Produce Safety Program Inspection
Basics
Produce Safety
Rule Inspection
Scheduling
During a
Produce Safety
Program
Inspection
Inspections
and Other
Resources
Questions About
Produce Safety
Program
Inspections
The Basics:
What:
Produce farms across the nation are now required to comply with federal regulations under a section of the Food Safety Modernization Act (FSMA) called the Produce Safety Rule and are subject to mandatory inspections as required by the U.S. Food and Drug Administration (FDA).
Who:
In California, on-farm inspections are conducted on behalf of the FDA by a special unit of the California Department of Food and Agriculture (CDFA) Inspection Services Division known as the Produce Safety Program.
Most California fruit, vegetable and nut farms are subject to regulations under the Produce Safety Rule. However, some produce items are exempt from regulations .
All farms with more than $25,000 in average annual produce sales (averaged over the previous three-year period) are required to comply with some or all parts of the Produce Safety Rule.
Why:
The Produce Safety Rule is now law for produce farms in the U.S., and operators of covered farms are obligated to follow the law. Practicing food safety on your farm is the right thing to do and can prevent the occurrence of foodborne illnesses. Covered farms that do not comply with the Produce Safety Rule may face economic, regulatory and legal consequences.
How:
The Produce Safety Program's role is to educate California produce farms on how to comply with the requirements of the Produce Safety Rule and then regulate farms to ensure they are in compliance with the Rule. The Produce Safety Program will conduct an inspection of your farm to ensure you are following regulations.
The Produce Safety Program's vision is safe produce through 100 percent compliance with the law. It's our goal for Produce Safety Rule requirements to become ingrained in the culture of California produce farming so that our state continues to grow and deliver the safest produce possible.
When:
At this time, the Produce Safety Program is scheduling farm inspections based on a random selection of farms and commodity harvest periods following verification of the farm's status. To assist in this effort, California produce farms are asked to complete this farmer questionnaire.
Where:
Produce Safety Rule inspections are being conducted on farms throughout California. Inspectors are located in five regions of the state, and the Produce Safety Program is headquartered at CDFA offices in Sacramento. You can learn more about the Produce Safety Program team here.
Preparing for a Produce Safety Rule Inspection:
Step 1: Take a Produce Safety Rule Training Course
One of the most important things a farmer can do to prepare for a Produce Safety Rule inspection is to take the Produce Safety Rule Grower Training Course. In fact, it is mandatory that every produce farm have an individual employed who has completed an FDA-approved Produce Safety Rule Grower Training, or equivalent course.
This course provides training to ensure a responsible party employed by the farm understands required food safety practices, can train other employees, and can recognize conditions that could lead to contamination of covered produce and take appropriate action to correct those conditions.
A California Produce Safety Program inspector will ask to see your designated food safety employee’s certificate as part of your on-farm inspection.
For more information on the Produce Safety Rule Grower Training Course and to find out where you can take it, please visit the Produce Safety Alliance (PSA) Grower Training Course website.
Step 2: Schedule an On-Farm Readiness Review
The Produce Safety Program offers non-regulatory On-Farm Readiness Reviews (OFRRs), especially for small and very small farms. These are designed to give farmers a better understanding of what they can expect from a routine Produce Safety Rule inspection. When you schedule an OFRR, a Produce Safety Program inspector will visit your farm and walk you through what will happen when you have a real inspection. This will help you prepare for an official Produce Safety Rule inspection.
Please note that the PSA Grower Training Course (see STEP 1) is required before scheduling an OFRR, and it is preferable to schedule an OFRR during harvest periods.
For more information or to schedule an OFRR, please email cdfa.isd_produce_safety@cdfa.ca.gov. Additional information is available on the Produce Safety Program Educate webpage.
Inspection Scheduling:
Most Produce Safety Rule inspections are announced, which means they will be scheduled ahead of time.
Produce farms in California can expect to receive a phone call from a scheduler who will ask a series of questions including the name of the person on your farm designated as in charge of produce safety. The date of your inspection should be assigned within 10 days of this initial call.
Prior to your inspection date, a Produce Safety Program inspector will contact you to verify the time and location of the inspection.
What to Expect During a Produce Safety Program Inspection:
An on-farm Produce Safety Rule inspection has three parts.
Introduction
When a Produce Safety Program inspector arrives at your farm, he or she will:
- Ask to meet with the designated produce safety employee or responsible party.
- Introduce themselves as a CDFA Produce Safety Program inspector, explain they are credentialled as an agent of the U.S. Food and Drug Administration and provide their name, title and proof of identity.
- Provide you with a document titled Notice of Inspection (FDA Form 482).
- Give a brief description of the inspection to be conducted.
- Inform you that Produce Safety Rule inspections take an average of 2-4 hours, but could take longer depending on farm operations and conditions.
Farm Walk Through:
This phase of the inspection is where food safety practices being implemented on your farm will be verified for compliance with the Produce Safety Rule and will involve the inspector observing activities taking place on your farm. The inspector will ask you questions about farm procedures, review records and documents, take notes, and may take photos or in some cases even collect samples.
The Produce Safety Program inspector may recommend that you change some procedures on your farm if they are found to be out of compliance with regulations. If these changes can be quickly made, you will be asked to make the correction that day. If the change cannot be made that day, you will be asked to propose corrective actions and a time frame in which the items must be corrected will be discussed at that time. Produce Safety Program inspectors have the authority to call in public health agency officials to temporarily halt operations if necessary. In rare cases, an inspector can ask that you cease harvest, packing or holding operations if conditions indicate there may be a potential health risk to the public.
In order to fully understand what an inspector will be looking for during a Produce Safety Rule inspection, it’s very important that
you or an employee on your farm complete an FDA-approved Produce Safety Rule Grower Training Course. This course (or an equivalent course) is required and is the best way to understand what is required under the Produce Safety Rule. The Produce Safety Rule inspection will cover requirements that fall under eight food safety categories. These eight categories are listed below along with examples of the items that will be reviewed as part of your inspection. PLEASE UNDERSTAND THE ITEMS LISTED BELOW ARE EXAMPLES OF WHAT WILL BE REVIEWED DURING YOUR INSPECTION. Many other items may be reviewed during your inspection in addition to those listed below.
Examples under Subpart C—Personnel Qualifications and Training:
- Inspector will ask you to describe your employee training program.
- Inspector will ask to review the designated employee’s certificate of food safety training equivalent to the standardized Produce Safety Rule Grower Training Course.
- Inspector may ask your employees about training they receive on your farm.
- You will be asked for documentation of employee training, which should include information such as a farm name and location, date and time of trainings conducted, topics covered, names of those participating and signatures of the party responsible for confirming the training occurred.
Examples under Subpart D—Health and Hygiene:
- Inspector will observe handwashing activities.
- Inspector will observe workers to make sure they are not eating, chewing gum or using tobacco in the field.
- Inspector may talk with employees to make sure they understand the health and hygiene policies on your farm.
- Inspector will ask how you make visitors aware of food safety policies and will ask to review a visitor policy or food safety policy for the farm.
Examples under Subpart E—Agricultural Water:
Note: Water requirements of the Produce Safety Rule are under revision and not currently being inspected against, but inspector will still do the following:
- Inspector will review your water sources for the farm.
- Inspector will review records of inspections of your water source if you have them.
- Inspector will examine wells and irrigation systems and look for backflow prevention devices.
- Inspector will ask if you are testing your water and ask to view your testing results if you have them.
Examples under Subpart F—Biological Soil Amendments:
- Inspector will ask if you use biological soil amendments and if so, what specifically do you use.
- Inspector will ask to see a Certificate of Analysis demonstrating that the biological soil amendments used on your farm have been treated to eliminate pathogens that may contaminate produce.
- If you create and use your own compost on the farm, inspector will ask to observe the operations and review process control logs (e.g., time, turning and temperature logs).
- Inspector will check to make sure that manure and compost are not stored in the vicinity of produce growing operations.
- If you use synthetic fertilizer, inspector will review synthetic fertilizer records to note what soil amendments are used on the farm.
Examples under Subpart I—Domesticated and Wild Animals:
- Inspector will check to see if animals are present during harvest activities.
- Inspector will walk the farm perimeter looking for signs that animals may be present.
- Inspector will ask what measures you take to assess areas on your farm for evidence of potential contamination and how you mitigate if evidence of contamination is observed.
- Inspector will review a pre-harvest assessment record if you have them to verify that risks from animal intrusion before harvest, if observed, were addressed.
Examples under Subpart K—Growing, Harvesting, Packing and Holding Activities:
- Inspector will observe harvest, packing and holding activities.
- Inspector will check to make sure employees are washing their hands before harvest and packing activities.
- Inspector will observe lunch and break periods to make sure these activities are in compliance with the Produce Safety Rule.
Examples under Subpart L—Equipment, Tools and Building Sanitation:
- Inspector will check procedures and review records for cleaning harvest equipment and tools.
- Inspector will determine if adequate supplies (e.g., paper towels, toilet paper, soap) are available in restrooms and handwashing facilities.
- Inspector will review records of restroom cleaning schedule with signatures confirming dates and times cleaning occurred.
- Documentation of cleaning practices will be reviewed to make sure they include the date, method of cleaning and the sanitizing equipment used.
Examples under Subpart O—Records:
- Inspector will ask to review documentation of food safety practices throughout your farm.
- Inspector will verify that all required records include the name and address of the farm, the actual values of observations, the date of record creation, and other required information.
- Inspector will verify that records are accurate and have not been falsified in any way.
- For more information and templates that might be helpful, view the Produce Safety Alliance Records Required by the FSMA Produce Safety Rule .
Exit Interview:
Following the walk-through, the inspector will:
- Review and discuss any observations, regulatory concerns or findings.
- Document any corrections implemented at the time of the inspection.
- Identify a time frame to implement corrective actions that could not be corrected that day.
- Answer any questions you may have about your inspection and farming operations, and provide you with resources or technical assistance contacts if needed.
- Discuss that you will receive a complete report including an Observation Form (FDA Form 4056) at the end of the inspection and a Produce Farm Inspection Report Form that documents the inspection and findings after the Compliance Officer reviews the report within three weeks.
- Provide you with agency contact information.
Unannounced Inspections:
Most inspections will be announced, which means they will be scheduled ahead of time. There are circumstances in which unannounced inspections may be conducted. The following are examples of when an unannounced inspection may occur:
- Your farm has had produce safety issues in the past and the issues have not been corrected.
- A follow-up inspection is needed and an unannounced inspection may work best to observe the necessary changes being made;
- Your farm is unresponsive (no contact within five (5) business days after reasonable contact attempts have been made) or is unwilling to set a date for the inspection; or
- In response to a complaint, recall, or foodborne outbreak investigation.
Videos and Other Resources:
Common Questions about Produce Safety Rule Inspections:
Are Produce Safety Rule inspections required by law?
Yes, Produce Safety Rule inspections are authorized by law under the federal Food Safety Modernization Act (FSMA), which was passed by Congress in 2011. You can find a link to the Produce Safety Rule and other resources on the California Department of Food and Agriculture Produce Safety Program Implement webpage.
Many operations that grow, harvest, pack, and hold produce are covered by the Produce Safety Rule and subject to inspection. To find out your operation’s coverage status, you can follow the U.S. Food and Drug Administration Standards for Produce Safety Coverage and Exemptions/Exclusions for 21 Part 112 flowchart. Other resources include an easy-to-follow flowchart prepared by the National Sustainable Agriculture Coalition.
Are inspections announced?
Yes, Produce Safety Rule inspections will generally be announced. An inspector will contact you about a week beforehand to schedule a time to visit your farm for inspections. Unannounced inspections can occasionally occur for cause or as directed by the California Department of Public Health and/or the U.S. Food and Drug Administration. For more information, visit the California Department of Food and Agriculture Produce Safety Program What to Expect During an Inspection webpage.
How often will Produce Safety Rule inspections be conducted? Will they be annual inspections?
The inspections will be conducted on a routine basis, but the exact frequency of the inspections has not been determined. It is estimated that routine inspections may occur every 1-5 years.
What happens if I am found to be out of compliance with the Produce Safety Rule?
The California Department of Food and Agriculture takes an interactive, educational approach to most compliance issues. The inspector and the compliance officer will provide education and work with the farmer to ensure that compliance is met. Additional actions may be taken depending on the severity of the violation; situations that result in an immediate risk to public health and safety may require immediate correction.
How long do I have to comply with the observations made?
Timelines for corrective actions will be discussed between inspector and grower. Typically, growers have about one month to correct any observation, unless it is egregious (i.e., an immediate risk to public health and safety), which will require immediate correction.
When am I required to comply with the Produce Safety Rule?
All farms covered by the Produce Safety Rule are now required to comply and all covered farms are subject to inspection. Staggered compliance dates were announced with the 2015 publication of the Produce Safety Rule and subsequent rulemaking. All of those compliance dates have now passed except for requirements in subpart E (agricultural water). The agricultural water requirements (other than sprouts) are being revised and will not be inspected against until after they are published in final form. Please visit the California Department of Food and Agriculture Produce Safety Program Implement webpage for more information.
What records are required during a Produce Safety Rule inspection?
All records must include the farm name, location and an adequate description of the topic of the record, including actual values and observations made. Records must be accurate, legible, indelible and must be initialed and dated. Records may be on paper or electronic; in whatever form they are created they must be made available to inspectors within 24 hours of request. Some records must be reviewed and signed by a responsible party. For more information and templates that might be helpful, view the Produce Safety Alliance Records Required by the FSMA Produce Safety Rule . The following categories of records are required and will be reviewed by an inspector, as outlined in the Produce Safety Rule:
Worker Training: All personnel who handle covered produce or food contact surfaces, or who are engaged in the supervision thereof, must have a combination of education, training, and experience to perform their assigned duties. The Produce Safety Rule provision 112.22 details particular training topics for all such personnel (principles of food hygiene and food safety, importance of health and personal hygiene, requirements relevant to their assigned duties), as well as for harvest workers (when covered produce may not be harvested, inspection of harvest containers and equipment, correcting problems with harvest containers and equipment). The record of worker training must include the topic(s) of the training, the date, and who attended (with initials). Training records must be reviewed and signed by a supervisor or responsible party.
Supervisor Training: The farm supervisor or another responsible party must complete a food safety training course as required by the Produce Safety Rule provision 112.22(c). A certificate of completion for this training will be reviewed by the inspector. The Produce Safety Alliance (PSA) Grower Training Course is recognized as adequate for this purpose; visit the PSA Upcoming Grower Trainings webpage for course offerings. Alternate curricula that are also recognized as adequate may become available. Visit the North Central Region Center for FSMA Training, Extension, and Technical Assistance webpage on Alternate Curriculum for updates about alternate curricula.
Agricultural Water System Inspection*: The Produce Safety Rule requires inspection of all agricultural water systems under the farm operation’s control to identify conditions that are reasonably likely to introduce known or reasonably foreseeable hazards into covered produce. A record of this inspection, its findings, and any corrective actions taken is required. Findings of the inspection of your agricultural water system will be reviewed during an inspection.
Agricultural Water Test Results*: Although testing the sanitary quality of agricultural water is not currently required under Subpart E of the Produce Safety Rule because of a compliance date extension, inspectors will review water testing results when farms have them.
* The U.S. Food and Drug Administration (FDA) published a stakeholder update about the FSMA Proposed Rule on Agricultural Water in December 2021, which addresses all requirements for agricultural water other than sprouts. Although these records and other requirements are not in effect until after the rulemaking process is complete, the FDA is clear in their documentation that adulteration of food (e.g., by contact of produce with contaminated water) is prohibited under the Food, Drug, and Cosmetics Act (FD&C).
Treatment Status for Biological Soil Amendments of Animal Origin (BSAAOs): If BSAAOs, such as compost or chicken pellets, are used as "treated" products when growing covered produce, then proof of treatment must be maintained by the grower for each lot of treated BSAAO. For a treated BSAAO you produce and use for your own covered farm, documentation must be included to show that process controls (e.g., for composting: time, temperature, turnings) were achieved. For a treated BSAAO you receive from a third party, a Certificate of Conformance that documents that a scientifically valid process with appropriate process monitoring was used must be kept in the farm record. For all treated BSAAO (on-farm or third-party), documentation should also specify that the treated BSAAO was handled, conveyed, and stored in a manner and location to minimize the risk of re-contamination after treatment.
Equipment and Tools Cleaning: Documentation of cleaning practices, including date and method of cleaning and sanitizing equipment or other food contact surfaces (if sanitized), is required. This record must be kept for any equipment used in contact with covered produce during harvesting, packing, or holding activities.
If my food safety consultant has the Produce Safety Alliance Grower Training certificate, does that cover my farm?
At least one supervisor or responsible party for a covered farm must be trained and can demonstrate this with a certificate of completion for Produce Safety Rule training (e.g., the Produce Safety Alliance Grower Training certificate). In general, a food safety consultant can be a valuable resource for the farm supervisor or responsible party. However, unless the consultant spends a lot of time on the individual farm and is involved in day-to-day operational decisions, the farm also should have at least one other person trained on Produce Safety Rule requirements.
Do all my employees need to have a Produce Safety Alliance (PSA) Grower Training certificate?
Farm personnel must have food safety training applicable to their positions to comply with the Produce Safety Rule, but they are not required to attend a PSA Grower Training Course. Training can be done on the farm, and it must take place upon hiring (before the personnel work with covered produce) and at least annually thereafter. Retraining is required if issues are found with worker performance of duties that affect produce safety.
The Produce Safety Rule provision 112.22 specifies particular training topics for all personnel who handle covered produce, food contact surfaces, or supervise those who do (principles of food hygiene and food safety, importance of health and personal hygiene, requirements relevant to their assigned duties) as well as specific topics for harvest workers (when covered produce may not be harvested, inspection of harvest containers and equipment, correcting problems with harvest containers and equipment). The PSA Grower Training Course is one way to get this information, but it may not be necessary for all personnel.
At a minimum, the person responsible for food safety and Produce Safety Rule compliance on the farm should have the knowledge and experience to fulfil that role. One way to accomplish this is by taking the PSA Grower Training Course or equivalent and having the certificate of completion.
I have contract laborers. Am I responsible for giving them training?
Contract laborers who handle covered produce and/or food contact surfaces must follow Produce Safety Rule (PSR) requirements. If third party contractors are hired, the responsibility of training ultimately belongs to the farm owner to ensure the farm has required training documents for the PSR during an inspection. Contract laborers must receive job-specific training in addition to general food safety and food hygiene policies. This includes recognizing covered produce that must not be harvested, inspection of harvest containers and equipment to ensure they are functioning properly, and reporting any issues with equipment to the person in charge of food safety at the operation. As part of your PSR inspection, you will be asked to provide records that show adequate training of personnel is taking place regularly regardless of whether your farm or the contract company provides the training.
What if contract laborers are hired by the packinghouse I use (e.g., huller facility, custom handler)? As a grower, am I responsible for the contract laborers’ Produce Safety Rule requirements?
Under the federal Food Safety Modernization Act (FSMA), there are two types of farm. A primary production farm primarily grows and harvests crops (or animals). A secondary activities farm is associated with the primary production farm and primarily harvests, packs, and holds raw agricultural commodities such as crops and animal products. If a packinghouse, as a secondary activities farm, hires the contract laborers then the owner of the packinghouse is ultimately responsible for the contract laborers’ Produce Safety Rule (PSR) requirements. During the inspection, the inspector will evaluate PSR requirements of the farm (including records) and will also ask questions pertaining to the relationship between the primary production farm and the packinghouse.
Will cleaning my equipment once a year be sufficient to pass inspections?
The Produce Safety Rule provisions 112.123(d)(1) and (2) state that you must inspect, maintain, and clean as frequently as reasonably necessary to protect covered produce. The necessary frequency of cleaning is based on how the equipment is used in your individual operation. If, during an inspection, the inspector encounters unclean food contact surfaces on equipment or other signs of potential contamination of covered product, a reassessment of the cleaning frequency will be done to ensure it is adequate to prevent foreseeable hazards. In addition, records must be maintained of cleaning activities.
How do I know if the equipment I use is suitable for produce?
In order to maintain clean and sanitary food contact surfaces, a farm should keep in mind Produce Safety Rule provision 112.123(a) that you must use equipment and tools that are of adequate design, construction, and workmanship to enable them to be adequately cleaned and properly maintained. This is one measure that is "reasonably necessary" to protect covered produce, food contact surfaces, and foodpacking material from contamination. More detailed information is available at the Food Safety Resource Clearinghouse Hygienic Design for Produce Farms website.
I do chemical testing on my water (alkalinity) but heard I must take more samples for produce safety. Can you explain what is needed in terms of water quality?
The water requirements of the Produce Safety Rule (PSR) are being revised; until then FDA recommends following Good Agricultural Practices (GAPs). Both GAPs and the proposed revision to the PSR require that farms inspect all agricultural water distribution systems at least once annually. The PSR also states that you are responsible to adequately maintain all agricultural water sources under your control and to implement reasonable measures to reduce the potential for foodborne contamination. In general, the contamination of concern for produce safety is fecal material from humans, wildlife, or domesticated animals. Other concerns may be apparent in your inspection, though (such as, trash and debris or dead animals).
Another water-related need (not currently required) is to test the water that is used in contact with covered produce or food contact surfaces, including irrigation water, pesticide applications, produce wash or cooling water, and hand washing. The specific test is for generic E. coli, because the presence of generic E. coli is a risk factor for presence of fecal contamination. For surface water sources, the proposed revision to the agricultural water requirements includes the option to sample for generic E. coli to understand the quality of your water. If you are using a municipal water source (city water), then you can obtain testing results from the water district. If you are using a ground water source like well water, then you might sample once or more per year: detection (presence) of any generic E. coli in the 100 mL sample indicates vulnerability of your well to contamination. For surface water sources, you might sample three to five times per year and calculate statistics (e.g., geometric mean) on the quantitative results of the tests. If you are covered by a program such as the California Leafy Greens Marketing Agreement (LGMA), follow program guidance about acceptable levels of generic E. coli.
What if I produce my own compost for fertilizer?
The Produce Safety Rule is clear about requirements for compost and other biological soil amendments of animal origin (BSAAO). The language in provision 112.52 says, in part, that you must handle, convey, and store any biological soil amendment of animal origin in a manner and location so that it does not become a potential source of contamination to covered produce, food contact surfaces, areas used for covered activities, water sources or distribution systems, or other soil amendments.
If the compost or other BSAAO is being used as a treated amendment (e.g., shorter time from application to harvest, or less restrictions on potential for contact with covered produce) then use a controlled, physical process; chemical process; or biological process (or combination of these) that has been scientifically validated to satisfy the microbial standards in provision 112.55 for (a) Listeria monocytogenes, Salmonella species, and E. coli O157:H7 or for (b) fecal coliforms and Salmonella species. Two examples that are validated to satisfy the microbial standards in provision 112.55(b) are static composting and turned composting, as long as process controls are followed and documented.
The Produce Safety Rule includes specific requirements for records related to treated BSAAOs such as compost; please view the "Treatment Status for Biological Soil Amendments of Animal Origin (BSAAOs)" section in the Records entry above for more information. In short, the record should show that control parameters were achieved and that the treated product was not re-contaminated.
Am I going to get a citation if a flock of birds lands out in my field when inspectors show up?
The Produce Safety Rule states that you must conduct a pre-harvest assessment of the growing area prior to harvest. In the situation described, the inspector will likely discuss remedies with the grower if it appears the flock of birds may lead to potential contamination of covered produce. The inspector might also ask about what steps are in place to determine and ensure any contaminated covered produce is not harvested.