The following resource, developed by 2023 IFPA Food Safety Intern Justin Daniel, summarizes insight gained through interviews with IFPA Food Safety Council Members who have undergone one or more FSVP inspections. Additionally, publicly available data from the FDA website has been compiled to identify the most common findings in FSVP inspection. This information is presented as a set of case studies to identify best practices and provide recommendations on how IFPA member companies can effectively pass FSVP inspections.
The following is offered for informational purposes and does not constitute legal advice. Official interpretations of FDA rules can be obtained by submitting an inquiry to FDA’s Technical Assistance Network (TAN). For scientific and technical questions (e.g., related to hazards, test methods, etc.), reach out to the Technical Assistance Network of the Food Safety Preventive Controls Alliance. You can also visit FDA’s FSMA website for official information, and sign up to receive alerts directly from FDA.
If my company is listed as an FSVP importer and believe that it is in error, what should we do to let FDA know?
FDA publishes the list of FDA importers quarterly based on customs entry filings. If you believe you have been listed in error, FDA suggests you file a Freedom of Information Act request. Based on our discussions with FDA, we developed a document on how to file a FOIA request that is likely to provide useful information to you (below).
I got a notice from FDA that I need to have a DUNS number, and that UNK will no longer be accepted. What should I do?
The final rule requires that the Customs Entry forms indicate the FSVP importer, including their DUNS number. FDA allowed a 5-year transition period for firms to obtain a DUNS number, and allowed the use of ‘UNK’ in the interim. As of July 24, 2022, UNK is no longer being accepted. DUNS numbers are specific to location and you may get a rejection or note from FDA if they see the same DUNS number associated with more than one location. You can request a new DUNS number from Dun & Bradstreet (D&B) through the D&B’s Import Safety Lookup Portal https://www.importregistration.dnb.com. You may also use the Portal to look-up a DUNS number or request an update to a current DUNS number.
If I import produce that isn’t subject to the produce safety rule (e.g. potato, asparagus, and other produce that is rarely consumed raw– see the list here) am I exempt since my foreign supplier (grower) is not subject to the Produce Safety Rule?
No. Just because your foreign supplier is exempt from the Produce Safety Rule, it doesn’t mean that you are exempt from FSVP. You still need to conduct a hazard analysis of the food (including chemical hazards such as pesticides, which are not addressed by the PSR), at a minimum, and fulfil the other FSVP requirements based on the hazard analysis.
My supplier is a distributor, aggregator, etc. Who and what am I supposed to verify?
“Foreign supplier” is defined as “the establishment that manufactures/processes the food, raises the animal, or grows the food that is exported to the United States without further manufacturing/processing by another establishment, except for further manufacturing/processing that consists solely of the addition of labeling or any similar activity of a de minimis nature” (see p 74341 of the rule). A distributor or aggregator does not meet this definition. As defined in the rule, the foreign supplier is the one growing or producing the food, and may be more than 1 step back in the supply chain. The rule requires you to verify that that entity is controlling the hazards identified in the hazard analysis as needing control.
Who is the foreign supplier of a produce RAC, the farm or the packinghouse?
“Foreign supplier” is defined as “the establishment that manufactures/processes the food, raises the animal, or grows the food that is exported to the United States without further manufacturing/processing by another establishment, except for further manufacturing/processing that consists solely of the addition of labeling or any similar activity of a de minimis nature” (see p 74341 of the rule). FDA has indicated that since a packinghouse does not do “manufacturing/processing”, the foreign supplier of a RAC would generally be the farm.
If I’m not the importer of record (which is a requirement of Customs and Border Control; not identical to FSVP importer), but I use imported products/ ingredients, do I need to comply with FSVP?
Maybe. The FSVP importer may be different from the importer of record. It depends on whether or not you meet the definition of FSVP importer, which is “U.S. owner or consignee of an article of food that is being offered for import into the United States. If there is no U.S. owner or consignee of an article of food at the time of U.S. entry, the importer is the U.S. agent or representative of the foreign owner or consignee at the time of entry, as confirmed in a signed statement of consent to serve as the importer under this subpart.” There are instances where the importer of record may not meet this definition (e.g., by not being US based), however an FSVP importer still needs to be identified.
Should I sign a letter from my customer asking me to take responsibility as the FSVP importer?
This depends on whether or not you meet the definition of an FSVP importer. If you do not meet this definition, you cannot be the FSVP importer.
I meet the definition of FSVP importer, but so does my customer (because they have agreed in writing to purchase the imported food from me). They are asking me to sign a statement saying I will bear the responsibilities of the FSVP importer. Is that allowed?
It’s true that in some situations, more than one entity may meet the definition of the FSVP importer. In that case, the supply chain needs to determine who, singularly, will be listed as the FSVP importer for that line of food on the Customs entry form, and be responsible for compliance (hazard analysis, supplier evaluation, approval, and verification activities). Signing a statement at your customer’s request is a business decision. Note that FDA requires records be retained for 2 years. If your supplier asks for a longer retention time, agreeing to that is a business decision; FDA will have access to records for as long as you keep them.
My foreign supplier (or broker, or customer) already conducted a hazard analysis for the product. Can I use that?
Yes, but you need to have it reviewed by a qualified individual who is able to ascertain if the original analysis is adequate. Also, you need to maintain documentation showing which hazards you are expecting the supplier to control (e.g., the hazard analysis, or comparable document).
The rule says that I don’t need to conduct a hazard analysis when I am importing produce covered by the Produce Safety Rule. Does this mean I don’t need to do anything to comply?
No. First, you do need to conduct a hazard analysis for any chemical or physical hazards (e.g., if the food is imported from a region where pesticides are not properly applied, or where there is high pollution, you may identify these hazards as needing controls). Second, the reason that you don’t need to evaluate microbiological hazards is because FDA assumes they are there and need to be controlled (through the implementation of the Produce Safety Rule). Therefore, you will always need to conduct verification of a farm growing covered produce (or ensure someone else in the supply chain is verifying the farm).
What does enforcement look like?
FDA is enforcing this rule. Importers are being contacted, often via email, to provide records demonstrating FSVP compliance. There are already several examples of FDA issuing warning letters to importers due to FSVP violations. The most common citation is not having an FSVP! A
FOIA REQUEST
Note to Industry: Addressing Erroneous Inclusion on FDA’s FSVP Importer List
Background
On a roughly quarterly basis, FDA posts the names of entities that have been identified on Customs Entry paperwork as FSVP importers. This list can be downloaded at the bottom of this page: https://www.fda.gov/food/importing-food-products-united-states/foreign-suppliers-verification-programs-list-participants. As of this writing, the list is sorted by state, and then by firm legal name, and the file contains the timeframe for which information is provided.
From time to time, companies have been surprised to see their names listed as FSVP importers. This document lays out the process to request details from FDA in order to understand how a company name/location wound up on the list.
If you don’t think you’re an FSVP importer:
At the web link above, FDA states “If you would like more information regarding entries for which you were declared as the FSVP importer, you can submit a Freedom of Information Act Request to request the publicly releasable data points for those entries for a related timeframe.” This document provides additional details on how to do this, and the information that should be provided by the inquiring firm in order to expedite a response from FDA.
- The company who feels they have been listed in error must file a Freedom of Information Act request. If the firm would like a 3rd party (e.g., an attorney) to make the request, the firm listed as the FSVP importer must grant permission to the 3rd party (e.g., on company letterhead) and this must accompany the request by the 3rd party.
- The FOIA request should include the dates/ timeframe of interest (e.g., if you’re listed in a report that covers March – May 2020, this would be the timeframe of interest). Bear in mind that implementation of the FSVP rule began May 30 2017; FSVP for importers of fresh produce covered by the Produce Safety rule began July 26, 2018. The broader the timeframe of the FOIA request, the longer it may take FDA to respond.
- The spelling of the firm name in the FOIA request should exactly match the spelling on the FDA list (even if there are typos). It’s recommended to also include the correct spelling, as well as any alternate spellings, subsidiaries, DBAs etc.
- The FOIA request should also include the DUNS number, and/or location of the alleged FSVP importer. Otherwise, a company with multiple locations may receive data for all locations (and again, the more extensive the request, the more time it will take for the agency to respond).
This information is provided as a service to the industry. It is not legal advice and is subject to change. Contact FDA or an attorney with specific questions.
Expected timeframe for response
FDA has dedicated staff and established processes to handle these FOIA requests. You should expect a response in about one month, depending on the scope of the request.
What to expect from the FOIA response
The inquirer will receive 23 data points associated with the entry(ies) in which the firm was listed as the FSVP importer. This includes the filer, the port of entry, and other information that the firm can use to follow up with those parties to address the improper naming of the FSVP importer.
NOTE
If you determine that you were improperly listed as the FSVP importer, be aware that the published list will not change, because the list reflects the company reported as the FSVP importer at the time of entry. However, your investigation into the error will be helpful so that in the future, the FSVP importer will be entered properly. You should proactively contact the filer and alert them that the declared FSVP importer is not the true FSVP importer and that they should identify the correct FSVP importer moving forward. It’s recommended to keep documentation of your inquiry, and any follow up with the filer, in case you are notified by FDA of an FSVP inspection related to this entry.