March 5, 2019
Food safety inspections on produce farms are beginning this month, but there are still questions as to what the first round of Food Safety Modernization Act (FSMA) Produce Safety Rule inspections will look like. The fact that the Food and Drug Administration (FDA) will be regulating farms for the first time is concerning for many produce farmers who have never interacted with FDA before on a regular basis. Adding to the anxiety for some producers, is the fact that this will be the first time in history that they will have to deal with regular inspections on their farm.
In order to help producers prepare, FDA has provided a preview of what a produce farm inspection might look like. Using the information provided by FDA and our own additional resources, the National Sustainable Agriculture Coalition (NSAC) details in this post what produce farmers might expect from the upcoming inspections, and provides some best practice tips for getting through the process as painlessly as possible.
There are several different types of inspections that might occur under the new FSMA regulations. Firstly, there will be a routine inspection for all farms covered under the Produce Safety Rule to ensure that they are in compliance. Routine inspections begin this year; in some states, inspections for larger farms will begin this month. For small farms (farms with a three year average of annual produce sales between $250,000-$500,000), routine inspections begin in Spring 2020.
There are also other reasons an FDA official or state regulator might show up on a farm. An unannounced inspection may be conducted if:
If a farm operation is conducting any processing or manufacturing activities that fall within the scope of the Preventive Controls Rule for Human Food, a separate inspection will most likely occur. NSAC’s resource Understanding FDA’s FSMA Rule for Food Facilities describes what type of farm activities might fall under the regulatory purview of the Preventive Controls Rule for Human Food.
FDA has agreed to allow state partners, like a State Department of Agriculture, to conduct inspections for FDA. In 44 states, a local state agency inspector, most likely from the State’s Department of Agriculture, will inspect the farm. In six states (Oregon, Wyoming, North Dakota, South Dakota, Iowa, Illinois, and the District of Columbia and all U.S. territories) FDA will conduct the inspections.
A significant number of produce farmers in the U.S. will most likely never interact with an FDA inspector. For more information on the states’ role in Produce Safety Rule inspections, read NSAC’s blog on the topic.
Before anything happens on the farm, an inspector will conduct a pre-inspection call to first determine whether the farm even falls under the Produce Safety Rule, and second to coordinate scheduling. Farmers should be prepared to answer a number of pre-inspection questions, including any questions about an exemption from the Produce Safety Rule.
To determine whether or not your operation is exempt from the Produce Safety Rule, start by walking through NSAC’s Produce Safety Rule section of the Am I Affected by the New Food Safety Rules flowchart. Farms that are exempt from all or parts of the Produce Safety Rule must provide records proving their exemption to the inspector. For additional information, please review FDA’s Regulatory Guidance document. Resources are also available through NSAC member NCAT via their ATTRA hotline (1-800-346-9140) and email (email@example.com).
If a farm is not exempt from the Produce Safety Rule, the inspection will be scheduled within five days of the initial pre-inspection phone call.
Farmers should inform the inspector during the pre-inspection phone call about any biosecurity practices the inspector is expected to follow, and any other safety protocols (for example, a visitors policy to prevent the contamination of produce).
On the day of an inspection, the inspector must first describe the type of inspection (for-cause, routine, etc.) that will take place and show their identification. Once the inspection begins, the farmer and any other individuals invited by the farmer to attend the inspection may be present (e.g., any person in charge of food safety on the farm, a food safety consultant, an attorney).
There are several things an inspector will most likely observe around the farm to ensure compliance with the Produce Safety Rule. For more information on the requirements produce farms must comply with, check out NSAC’s Understanding FDA’s FSMA Rule for Produce Farms publication.
The inspector will then fill out FDA’s new Form 4056 (NOTE: this pdf form cannot be viewed in a browser and must be downloaded to view). The inspector will check one of two boxes under the “Reportable Observations Made During the Inspection” section on the form. If the inspector checks the first box, then the inspector did not observe any conditions to be reported; in other words, there were no violations to report. If this is the case, the remainder of the document will not be filled out.
If the inspector checks the second box, that means that observed reportable conditions were present. Each violation will then be listed under the appropriate section of the rule on the form. The inspector will also note if a corrective action was taken under the appropriate section on the form.
If the inspector finds an issue or condition that will lead to the contamination of covered produce, the inspector will discuss with the farmer a plan for correcting the issue(s). There might be some actions the inspector recommends the farm take immediately to correct any violations.
If the farm corrects all of the inspector’s reported conditions, and no contaminated produce is made available for sale to consumers, then it is highly unlikely a regulatory response will occur. Different regulatory responses might occur if a farm is unable to sufficiently address the issue or violation, including but not limited to: a stop sale order to prevent any further sales of the farm’s produce; a fine; a seizure of the farm’s produce; a mandatory recall.
At the end of the inspection, the inspector will leave the completed Form 4056 with the farmer.
Answer your phone!
Designate someone to check the farm’s frequently used phone numbers and voicemail if the main operators are away. If the farm fails to respond to an inspection inquiry within five days, an inspector will most likely show up unannounced on the farm. The inspector might follow up with a letter in the mail or an email to the farm’s business address, or if known, the farm owner’s personal email address. Designate someone to check these as well if the main operators are on vacation, ill, or away for some other reason.
There is a new inspection form
FDA’s Form 4056 Produce Farm Inspection Observations is specific to the Produce Safety Rule. NSAC applauds FDA and the National Association of State Departments of Agriculture’s (NASDA) efforts to create a new form for the Produce Safety Rule. The form used for inspections of food facilities, Form 483, would not have been adaptable or practical for farm inspections.
Address violations while the Inspector is present, if possible
An inspector may not return for an unannounced inspection or issue any regulatory response if the violation is immediately corrected during the routine inspection.
What about agricultural water?
While FDA’s new Form 4056 currently notes the water testing requirements and records, the agricultural water compliance dates are not for a few more years. Farmers should pay attention in future years to when an inspector might begin to enforce these sections of the Produce Safety Rule.
There are still several unanswered questions about how inspections will be conducted. With both states and FDA conducting inspections, one big question is how inspections, compliance, and regulatory action might differ depending on states’ laws and regulations.
Compliance and enforcement actions might also differ based on whether the state or FDA is the enforcing authority. In the states where the State Department of Agriculture conducts the inspection and the state has adopted (at a minimum) the authority to enforce the federal produce safety rule requirements, that state will decide what enforcement action to take in the event of a violation. If the state has not adopted authority to enforce the Produce Safety Rule, the State Department of Agriculture will inform FDA of the violation and FDA will determine the appropriate enforcement action.
In some states, such as Arizona, a violation of the Produce Safety Rule can result in a fine, re-inspection, stop sale order, and seizure and embargo of contaminated produce. It is not clear, however, what enforcement and compliance actions will be taken in every state. The FDA and the states should include in their inspection factsheets additional details on what types of violations might trigger certain types of regulatory responses. Farmers should have adequate notice about what type of action might occur if an inspector finds an alleged violation during a routine inspection.
Are there different rules or requirements depending on varying state laws and regulations?
In some states, farms are encouraged to register or fill out a survey to determine whether or not the farm is exempt or covered by the produce safety rule. FDA does not, however, require farms to register.
No clear process exists for issuing complaints against an inspector or appealing an adverse decision
The process will most likely differ depending on whether the decision was made by a state inspector or the FDA. FDA has stated that all FDA inspector issues can be directed to either Joann Givens, Program Director, Offices of Human and Animal Food Operations, at 301-796-7761, or Glenn Bass, Senior Advisor, Human and Animal Food Program, at 240-402-4894.
Is the information collected from an inspection protected from public disclosure?
The general public may or may not be able to access certain information about a farm’s inspection depending on the laws governing the enforcement authority. It’s currently unclear whether or not the Freedom of Information Act (FOIA) will require FDA to disclose certain inspections documents. As for the states, it will most likely vary depending on state law, but some states have already passed laws stating that the public will not be able to access certain inspection records.
How will the states and FDA inspect qualified exempt farms?
It is unclear how these inspections will play out practically, and also if exempt and qualified exempt farms should show an inspector their records proving their exemption (or any other required records). FDA has stated that they are considering on-farm record reviews for qualified exempt farms, while states will follow their own protocols for qualified exempt farms. NSAC encourages FDA and the states to provide exempt and qualified exempt farmers with clarity about when and how these records will be inspected. There is also a lack of clarity around what an inspector will observe if they show up on a qualified exempt farm. NSAC urges FDA and the states to confirm that only required records will be observed on a qualified exempt farm.
What actions beyond those observed at a routine inspection could lead to an unannounced inspection?
Several unclear definitions could be cause for concern regarding this question. For example, what qualifies as a “complaint” that would lead to an unannounced inspection? What “past issues” might lead to an unannounced inspection? We urge FDA and the states to provide additional details regarding what could lead to unannounced inspections.
How long are inspections expected to last, and will they vary by operation size?
Once inspectors have a clear idea of an estimated amount of time for an inspection, they should provide that estimate to the farmer who is about to undergo an inspection. This will allow farmers to prepare for the amount of time an inspection will take and ensure daily operations are not interrupted.
NSAC hopes to address several of the above questions with FDA in the future, and will provide additional information on the Produce Safety Rule and inspections as it is available.
NASDA’s inspection protocol documents and inspection training video for state inspectors are expected be released soon; these will be an important resource as NASDA collaborated with FDA on the forms and inspection documents that FDA recently released. In the future, additional inspection protocol resources from NASDA may also become available. FDA released a new resource earlier this year, a video on “Produce Inspections for Regulators”.
Lastly, several Produce Industry Coalition partners – including NSAC, United Fresh, the Produce Marketing Association, Western Growers, and the Canadian Produce Marketing Association – developed an FDA webinar series on the Produce Safety Rule Guidance Document and Produce Safety Rule Inspections. Those resources will be available at www.pma.com next week.
This post is not legal advice. For specific information on how a Produce Safety Rule Inspection might impact your operation, please contact an attorney.