Once a commodity has been shown to contain an illegal pesticide residue, the shipment is refused entry into the United States, and either must be re-exported to another country or destroyed. US Food and Drug Administration places the EXPORTER of that commodity under its DWE Program.
Under the Automatic Detention program, every new shipment from that exporter must be analyzed by a private laboratory for the same illegal pesticide. Only if the new shipment is found to be below established tolerance the Level of Quantification (LOQ) for that pesticide, will the FDA allow it to be released into the channels of trade.
Everything from sampling to analytical methodology to reporting must be performed using extremely strict protocols, or the analytical data package will be rejected, subjecting the importer to further delays, or possible refusal of entry. Generally after 5 clean shipments in a row the exporter may petition to be removed from Automatic Detention.
FDA sampling procedures requires that a third party perform the sampling. EMA does not offer sampling services for DWE except in very special circumstances. Please contact us if you need assistance finding a third party sampler. Here is some helpful information on the sampling process:
FDA Sampling Protocol: For a printable version please click here. For a printable version of FDA Sampling Form please click here.
Collecting samples on FDA Detention Withou Pysical Examination requires careful attention to detail. This is the first stage in a legal process to ensure that the commodity meets legal pesticide residue tolerance laws, and a data package wich includes the sample collection form is required by FDA to release product for distribution into the United States. Deviations from the procedures or incomplete documentation may result in delays for release or rejection of the data package by FDA.
Here are the proper sampling steps:
1) Gather sample collection materials. These should include FDA Sample Collection Form, Import Documents (including Bill of Lading, FDA Notice of Action, and Commercial Invoice), a digital camera, 10 individual sample collection containers (usually gallon size zip-lock bags will suffice), shipping container(s), blue ice or dry ice (Unless dehydrated or canned), as indicated, a marker to label sample collection containers, rubber gloves, and a top loading scale.
2) Count all containers in the shipment, to verify that the number matches the notice of action. Verify that the container and item or lot codes on the invoice and bill of lading match the shipment.
3) Select 10 containers at random from the shipment. Ensure that each subsample is collected from a different pallet, and at a different part (Top, Middle, Bottom) of each pallet (if applicable). Open each container and select a sub-sample of about 2 pounds from each container if fresh, or 100g if dehydrated. Place that sub-sample into a zip lock bag and seal it. Label each bag with the Entry Number, followed by the sub sample number (1 of 10, 2 of 10, etc.), date sampled, and sampler name and initials.
4) Complete all sample collection portions of the FDA Sample Collection form, leaving the “Laboratory” section to be filled in by the laboratory. Be sure to include Entry Number and line number, provide informationon how the lot identity was verified, and a description of where each sample was pulled from.
5) Ensure that the following photos for each line being sampled are taken during the sampleing: entire lot(s) being sample, the case’s product label, a photo showing containers being taken from different parts of the pallets, a picture of all subsamples gathered for an individual entry/line, and a picture showing the samples packed into the shipping container.
6) Load all samples into the shipping container with the blue ice (unless the product is dried), place the FDA Sample collection form and sample collection photos into a plastic bag along with a copy of the import documents, and place it into the shipping container as well. For multiple samples being shipped in the same box, ensure that each entry/line’s sampling documents are kept separate from each other.
7) Send the shipping container by overnight courier to:
EMA Inc.,
460 N. East St.
Woodland, CA 95776
