A Technical Information Bulletin
of the
Northwest Horticultural Council
Importing Shipments Rejected Overseas
(U.S. Return Goods)
Background
Fruit shipments from the United States at times have been denied entry by Israel, due to its detection of post-harvest diseases of plant health quarantine concern to that country. Shippers sometimes seek to return such rejected ocean containers to the United States only to fail due to the U.S. Food and Drug Administration’s (FDA) import clearance process at the Port of Newark, New Jersey. After an often frustrating process of trying to gain acceptance by FDA, fruit has been eventually destroyed by shippers, at costs significantly higher to them than if the fruit had been simply destroyed overseas after the initial rejection by Israel.
Decay has often been at the source of the problems encountered when seeking approval from FDA to clear returned shipments into the commerce of the United States. While reconditioning and repacking the fruit can be requested, the process for obtaining permission to do so is lengthy. Further delays and costs mount when seeking permission to destroy any rejected product.
FDA cites the Food Drug & Cosmetic Act’s prohibitory language that the “article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food,” when declaring the fruit adulterated and detaining or refusing shipments for the presence of decay.
There are no specific FDA tolerances (called defect action levels or DALs) for rot/mold/decay for fresh fruits and vegetables. When there are no DALs for a particular product, the tolerance level to determine adulteration is made on a case-by-case basis. The case-by-case determination applies regardless of where in the supply chain the inspection by FDA is conducted, e.g., in the packing house, in storage, or in transit.
General Information
The U.S. Customs and Border Protection (CBP) agency has the primary responsibility for enforcing U.S. import requirements and coordinates with other departments, such as FDA and the U.S. Department of Agriculture, to ensure that imported fruits meet U.S. law. FDA compliance officers determine if a shipment meets U.S. food law, and if not, if the shipment can be brought into compliance through repacking or reconditioning. If it is determined that the shipment should be refused entry, re-exported or destroyed, such action will normally be overseen by CBP.
Export shipments of U.S. goods (fruit) returned to the United States, regardless of ownership, are subject to the same laws and regulatory clearance process as imported goods of foreign origin. In other words, goods produced in the United States that are exported, and then returned to the U.S., are considered imports.
The rejection of a shipment by trading partners occurs infrequently, but can occur for any number of regulatory reasons. The most common of which are the detection of a plant pest of quarantine concern to the destination market or a pesticide MRL violation. Returning the shipment to the U.S. after either of these two categories of rejections should not result in denial of re-entry into our country by U.S. regulatory agencies, so long as the plant pest is not of quarantine significance to the U.S. itself or the chemical MRL in question is in compliance with U.S. standards.
Prior Notice
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 requires that FDA receive prior notice of food imported into the United States. Prior notice is designed to assist FDA in targeting inspections and determining what food might pose a threat or serious risk to human health.
The importer or customs house broker provides prior notice information through the Automated Broker Interface (ABI) of the Automated Commercial Environment (ACE) electronic system. The U.S. Customs and Border Protection passes the prior notice information to FDA through a separate electronic system, FDA’s Operational and Administrative System for Import Support (OASIS).
One of the prior notice requirements, added through the Food Safety Modernization Act, is to inform FDA if the food has been denied entry to another country and if so, name said country. This information alerts FDA to the risk of potential adulteration and flags the shipment for special attention.
Depending on the electronic portal utilized, prior notice must be received by FDA no more than 15 to 30 calendar days before the anticipated date of shipment arrival. If product is arriving by ocean vessel a minimum of 8 hours advance notice is required.
When the entry documents required for prior notice are submitted, the shipper’s clearing agent should also submit any documents that explain why the shipment was rejected overseas and why such a rejection should not prevent entry of the product into the United States.
FDA Notifications
During the life of an import entry FDA may issue a number of notifications informing interested parties of the shipment’s status. Absent a notification of entry, a “Notice of FDA Action” (e.g., “sample collected”, “detained”, “hearing”, “released”, “rejected”) is often the first indication there is a potential problem. In the event a violation is found FDA will issue a “Notice of Detention & Hearing”. These notices are often e-mailed to the importer or broker to speed the exchange of information, but official notice must be delivered to the import agent as hard copy.
It is difficult to contact FDA officials in the district offices by phone. When a “Notice of FDA Action” is issued it will indicate the name and contact information for the compliance officer that is assigned to the shipment. Further detail regarding the shipment and reason for rejection overseas can then be directed to that official by e-mail with a request to verbally discuss the situation by phone.
Detailed information on FDA’s Import Operations and Actions may be found in the Regulatory Procedures Manual.
FDA Offices
FDA District Offices manage the clearance of imported fruit shipments. Contact information for each office may be found at the Import Program.
NHC Recommendation
Before a commercial decision is made to return a shipment to the United States, carefully evaluate the level of decay and fruit condition. While there is no established tolerance for the level of decay FDA will accept, levels of decay above 15 percent have triggered rejections and requests for reconditioning.
FDA does prioritize decision making related to perishable shipments. However, the prioritization regards the initial decision to release or detain a shipment. If a decision is made to hold the shipment, decision timelines become significantly longer.
Work cooperatively with FDA’s District Offices prior to vessel arrival. Compliance officers have significant authority and absent a formal complaint or appeal there is little recourse for challenging decisions.
The Northwest Horticultural Council represents the deciduous tree fruit industry of Idaho, Oregon, and Washington on national and international policy issues affecting growers and shippers. For further information, contact the NHC at 509-453-3193.
Updated 2/6/2023
