Disclaimer: The following industry guidance is provided by the International Fresh Produce Association (IFPA). The information provided herein is offered in good faith and believed to be reliable, but is made without warranty, expressed or implied, as to merchantability, fitness for a particular purpose, or any other matter. This information is not designed to apply to any specific operation. It is the responsibility of the user of this document to verify that this information is relevant and applicable to their operation. IFPA, our members and contributors do not assume any responsibility for compliance with applicable laws and regulations. It is recommended that users consult with their own legal and technical advisers to be sure that their own procedures meet applicable requirements.
Given that over half of the fresh produce in the U.S. marketplace is imported, understanding the import process is imperative to successfully bringing safe fruits and vegetables into the country, while avoiding delays that may lead to high financial cost and product waste.
This document is intended to provide insight and clarification to common industry questions as it pertains to FDA’s import process for fresh produce.
This document does NOT address import procedures required by U.S. Customs and Border Protection (CBP) or phytosanitary requirements of the U.S. Department of Agriculture (USDA).
For a high-level overview of the import process for FDA-regulated products, FDA has developed the following short video: Importing FDA-Regulated Products: The Import Process.
Port of Entry vs. Port of Arrival
One key piece of information that impacts the import process is understanding where the process occurs. Your flexibility to transport product during this time can differ based on whether an importer decides that the shipment’s Port of Arrival and the Port of Entry are the same location, or if they are two different locations. In many instances, the Port of Arrival and the Port of Entry are the same, but they do not have to be (note that there may be different bond requirements for CBP in this case).
The Port of Arrival is the location where the product is first offered for import into the U.S. This may be either the port of unloading (if arriving by water or air) or the port where the product first crosses the border into the U.S (if arriving by land) [21 CFR § 1.276]. It does not have to be the same port where warehouse entry is presented to CBP.
The Port of Entry is any place at which a CBP officer is authorized to accept entries of merchandise to collect duties [19 CFR § 101.1].
FDA inspections and sampling of imported produce occur within the Port of Entry geographic area. A list of Ports of Entry in all 50 states can be found on CBP’s webpage.
What if my product is sampled by FDA at the Port of Entry?
- FDA uses a risk-based screening tool “PREDICT” to determine whether a shipment “may proceed” without physical inspection or sampling, or if an inspector needs take action such as visual surveillance and verification, collecting samples for testing, or placing the product under detention (e.g., for products under ‘Detention without physical examination’ listing)
- If FDA decides to collect a sample, it will provide the filer, importer, owner and/or consignee, where appropriate, with a Notice of Action/Notice of Sampling. This notice:
- advises whether the entry is to be held intact for FDA examination or sampling; and,
- specifies the items that need to be held.
- More information on FDA import sampling can be found here.
What does this mean for transportation of my product after arriving at the Port of Entry?
- FDA does not require product to be held at or near the port of entry prior to an admissibility decision being made (i.e., no ’50-mile’ radius rule). However, if FDA decides to conduct a physical examination or collect a sample of product that has already been moved, FDA can work with CBP to require the product be returned to the Port of Entry. The same holds true if sampled product has been found to be violative.
- For this reason, if an importer decides to transport product prior to an import admissibility decision being made, product must remain in the control of that importer!
- If product has been further distributed by the importer/consignee prior to receiving an FDA release from import status, this is considered a “Failure to hold” violation.
- If the products are not returned to CBP for FDA examination or sample collection, bond action may be taken.
- Because of the perishability of fresh produce, if an importer has warehouses, cold storage facilities, or other receiving facilities in a location nearby to a Port of Entry, it may be advantageous to choose that location as the product’s Port of Entry, separate from the Port of Arrival, in the event that a shipment is sampled and/or held for examination by FDA. This way, product may be transported nearer to the ultimate destination (or a location where the importer has available storage), sooner.
What does DWPE mean, how does it relate to an Import Alert, and what is its significance?
- Import alerts are issued by FDA when there is a history of violative products (according to the Federal Food, Drug, and Cosmetic Act [FD&C Act]) associated with a specific commodity, shipper/manufacturer, and/or region, or when there is sufficient indication that future import entries may be violative.
- An import alert can be issued by shipper/manufacturer, by manufacturer/product combination, or in some circumstances by region/commodity. These listings of import alerts are also known as the Red List.
- If a firm, product, and/or region is Red Listed, future imports will be subject to Detention Without Physical Examination (DWPE). DWPE allows the agency to detain all future shipments without physically examining them at the time of entry.
- More information on FDA Import Alerts can be found here.
Can I still export product to the U.S. if my firm is listed on an import alert and subject to DWPE?
- Individual shipments from parties subject to DWPE may still be imported if the owner, consignee, and/or other responsible party provides evidence which demonstrates that the product doesn’t contain the violation listed in the import alert.
- Evidence should be submitted to FDA using the Import Trade Auxiliary Communications System (ITACS).
- If importers don’t respond to FDA’s “Notice of Detention and Hearing” or if the evidence provided is not sufficient, their product will be refused entry.
Why might fresh produce commodities or fresh produce importers be added to an import alert?
- In fresh produce, the most common reasons for import alerts include illegal pesticide residues or contamination by microbial pathogens.
- Various types of processed/dried fruits and vegetables and concentrated juices from certain countries have been issued import alerts due to the presence of heavy metals (i.e., lead, arsenic, cadmium).
- This link on the FDA website includes lists of import alerts categorized by product type.
How do I get my firm off of an import alert?
- Because import alerts are typically issued in response to a history of violative product, a firm needs to demonstrate to the FDA that the issue has been addressed and corrected, and corrective actions have been applied to prevent future violations.
- In other words, firms must “overcome the appearance of violation”.
- In many instances, lab results from an established sampling plan are an important component to being Green Listed.
- In the future, any product testing being completed to support admission of an imported food must be done by an accredited lab according to the Laboratory Accreditation FSMA Final Rule.
- FDA may require a minimum of five (5) consecutive non-violative commercial shipments to confirm the continued effectiveness of any corrective actions before the agency can consider that the appearance of the violation has been overcome, and that it may be appropriate to remove the DWPE.
- This applies when product has been declared violative under violative under Section 801(a)(3) of the FD&C Act.
- The specific import alert may include more details on requirements before a firm is removed, but FDA has provided some general recommendations on supporting evidence to help with removal, including:
- Third-party laboratory analyses
- Manufacturing or processing records
- FDA establishment inspections
- Proof of registration and/or listing
- Proof of certification by a foreign government or certified body
- Evidence that labeling violations have been corrected
- Evidence that the product is in compliance
- As another example, IFPA has prepared guidance to help the Mexican papaya industry understand the kinds of information FDA may want to review when preparing a petition for green listing related to Import Alert 21-17.
How will I know, and what should I do if my supplier is listed on an import alert?
- FDA updates import alerts nightly and publishes a weekly list of firms that have been put on import alert. Anyone can sign up to receive email notifications.
- As a reminder, FDA defines “supplier” for the purpose of compliance with FSVP and Subpart G of the Preventive Controls Rule (the supply chain requirement) as the one that grew or processed/ manufactured the food. It’s important to understand the entities in your supply chain so that you can determine if one of them has been placed on import alert.
- If you find that a member of your supply chain is subject to import alert, IFPA recommends that you contact the firm directly to understand the situation and assess if your supply chain is or could be impacted. This should include details around which product/farms were implicated AND what steps are being taken to prevent the issue from recurring.
- In general, obtaining negative test results without having assessed the root cause of the problem is not an ideal solution.
Can FDA provide more details related to a firm on an import alert?
- The entry process is a commercial matter between the entities identified in the entry transaction (i.e. the importer of record or the consignee), and FDA is prevented from discussing import entries with anyone not identified as a party to the transaction.
- If you notice your supplier is included on an Import Alert, you should reach out directly to that supplier for more information.
- If your firm is listed on an Import Alert and you would like to address the issue, begin by reaching out directly to the FDA Compliance Officer at the relevant Port of Entry (provided your firm was party on an entry). You may also contact FDA's Division of Import Operations, the component overseeing FDA’s Import Alert system, at FDAImportsInquiry@fda.hhs.gov, to submit an administrative file request. This administrative file will consist of the evidence in FDA's possession leading to the Import Alert addition, including the laboratory analytical results (or other evidence) indicating the presence of the contaminant.
- Additional relevant FDA contacts may also be listed on the individual Import Alert.
How can I expedite the entry of imports into the US?
- As part of FSMA, FDA developed the Voluntary Qualified Importer Program (VQIP)
- VQIP is a voluntary fee-based program offers expedited review and import entry into the U.S. for participating importers. Product imported by a VQIP-approved importer will generally receive a “may proceed” recommendation upon arrival without going to an FDA reviewer for processing.
- Examination and/or sampling of VQIP food entries are generally limited to “for cause” situations (i.e., when the food is or may be associated with a risk to the public health) and to audit VQIP.
For additional information, see the following resources provided by FDA:
- FDA Regulatory Procedures Manual, Chapter 9: Import Operations and Actions]
- FDA Investigations Operations Manual, Chapter 6 - Imports
- FDA Resources for Private Laboratory Testing