Import Sample Related Frequently Asked Questions*

Catherine L. Vieweg, Director of Compliance Branch

Southwest Import District, FDA

December, 2012

1)How long will it take for my fresh produce sample to be analyzed? Which fresh produce commodities get tested for which microorganisms?

Initial results for fresh product pesticide analyses are that either no residues are found or that residues are found; initial results for microbiological analyses are that either no organisms of concern have been found or that a possible organism of concern has been found. For microbiological samples, Saturday is also a business day.

Fresh Produce Pesticide Samples: by the end of the next business day after the lab receives the sample, which is ordinarily the day after the sample is collected. For example, if a sample is collected on a Monday, we often have an initial result on Tuesday and consider it late if we do not have an initial result by close of business on Wednesday.

Fresh Produce Salmonella Samples: by the end of the second business day after the lab receives the sample, which is ordinarily the day after the sample is collected. For example, if a sample is collected on a Monday, we often have an initial result on Wednesday and consider it late if we do not have an initial result by close of business on Thursday.

Fresh Produce E. coli O157:H7 and Listeria Monocytogenes Samples: by the end of the fourth business day after the lab receives the sample, which is ordinarily the day after the sample is collected. For example, if a sample is collected on a Monday, initial results are expected Saturday.

Fresh Produce Hepatitis A Samples: by the end of the fourth business day after the lab receives the sample, which is ordinarily the day after the sample is collected. For this analysis, there are no initial results, only final results. For example, if a sample is collected on a Monday, final results are expected Saturday.

Commodity: Possible Sample Analyses

Cantaloupe:Listeria monocytogenes and/or Salmonella

Tomatoes:Salmonella

Leafy Greens:E. coli O157:H7, Listeria monocytogenes and/or Salmonella

Basil:E. coli O157:H7 and/or Salmonella

Peppers, sweet (bell):Salmonella

Peppers, hot jalapeno, Serrano: Salmonella

Green Onions: Hepatitis A and/or Salmonella

Mango:Salmonella

Cilantro: E. coli O157:H7 and/or Salmonella

Parsley:E. coli O157:H7 and/or Salmonella

Cucumbers:Salmonella

Papaya:Salmonella

2)What is a Customs Broker? Do I have to have one? How do I find one? Can I import the shipment myself?

A customs broker is a person who has passed a licensing examination and a background check, and been granted authority by Customs to act on the behalf of an importer of merchandise. Every customs brokerage (company) has to have a qualified customs broker on hand. The broker will prepare the paperwork, post any duties, fees and taxes due the government, and on the behalf of the importer, answer questions about the shipment from Customs and other agencies, such as FDA. The broker will also do all the electronic record transmissions required by Customs. The importer of the merchandise remains liable for the accuracy of the shipment information, and any money owed the government, even when a broker is involved.

Customs will determine whether a particular shipment requires a formal entry. Any importer has the right to import their own shipment without engaging a broker, but often times complying with the government requirements, or the cost and difficulties of obtaining a bond to cover duties, fees and taxes will make the choice to use a broker the prudent business decision.

Local port offices have list of brokers authorized to conduct business in their port. The CBP website ( also has an area where brokers can be located by port. Neither FDA nor CBP can recommend a broker for you.

3)What is OASIS? What is MARCS?

OASIS stands for Operational and Administrative System for Import Support. OASIS is an automated FDA system for processing and making admissibility determinations for shipments of foreign-origin FDA-regulated products seeking to enter domestic commerce. OASIS enables FDA to handle more efficiently and effectively the burgeoning volume of shipments.

4)What is the ABI? The ABI message is ‘Doc/Req’? Where do I send the documents?

ABI stands for Automated Broker Interface. The ABIconnects brokers to Customs and Border Protection and permits qualified participants to file import data electronically. ABI is a voluntary program available to brokers, importers, carriers, port authorities, and independent service centers. Currently, over 96% of all entries are filed through ABI.

ABI expedites the release of merchandise for the trade community. Entry summaries are electronically transmitted, validated, confirmed, corrected, and paid. Administrative messages keep participants informed of all current information and issues. Brokers have access to current entry status via the ABI 24 hours a day, seven days a week, 365 days a year.

The ABI message of ‘Doc/Req’ means that entry documents have been requested by FDA and the filer needs to provide entry documents to the FDA office handling the entry.

We encourage entry documents are sent through ITACS – Import Trade Auxiliary Communication System, found here:

5)What is ‘entry review’ and how long does it take?

Entry review is what the FDA calls the initial review of electronic and/or documentation and/or examination/sampling of the goods offered for entry. Products that have a very short life, such as fresh produce, are prioritized for entry review. In general, the FDA will usually either release the goods or request documents (see Question #4, above) within one to two working days. If documents are requested, then the FDA usually considers itself to have approximately five working days after receipt of the documents to decide upon further action.

The FDA is committed to timely review and often does not require all the time described in the above paragraph.

6)FDA has collected a sample from my entry. How do I find out the results? How long will it take to get the results? What if the results show there is a problem?

The FDA investigator or inspector who collected the sample should have provided a general idea of how long the sample analysis will take. is an email address you may use to inquire as to the status of a sample, also.

If the results show a violation, then the Compliance Officer will usually detain the goods. See the FAQ for Detention for more information.

Your broker has access to current entry status via the ABI 24 hours a day, seven days a week, 365 days a year, see question #4, above.

7)What is an ‘FDA Notice of Action’ and what does it mean? Will I always get a notice for each entry?

An ‘FDA Notice of Action’ is the written legal notice that FDA uses to communicate information about an entry. When generated, a copy is provided to the importer, filer and consignee. Such notices are generated only if the FDA takes certain steps such as sampling or detaining an entry and so notices are not generated for every entry.

8)What is an Import Alert? What is Detention Without Physical Examination? If my product is sampled and has a bad result, will you stop the next shipments? Will it be placed on Import Alert?

Detention Without Physical Examination, abbreviated DWPE and first used by FDA in 1974, is appropriate when there exists a history of the importation of violative products, or products that may appear violative, or when other information indicates that future entries may appear violative. Detention without physical examinationhas the effect of reminding the importing community that FDA is a regulatory agency, not a quality control laboratory. Detention without physical examinationproperly places the responsibility for ensuring compliance with the law on the importer.

Import Alerts identify problem commodities and/or shippers and/or importers and provide guidance for import coverage. Import Alerts will identify those products or shippers that have met the criteria for DWPE.

For example, if an entry of lettuce from a particular source is found to have an illegal pesticide residue, then the next entry of lettuce from that same source would be subject to DWPE. That lettuce would also be added to the appropriate Import Alert (in this case, Import Alert 99-05). See Question #11 to learn about how products come off of an Import Alert or become exempt from DWPE.

The significance of detention is that if the appearance of the violation is not overcome, or the violation is not otherwise fixed, then the product will be refused entry by the FDA.

9)How do I get my product off of an Import Alert?

To lean about how to qualify for exemption from an Import Alert, first you must review the specific Import Alert your entry is subject to and see if there are any specific instructions or requirements contained within regarding qualification for exemption. The Import Alerts are found here:

Removal or exemption from Import Alerts (Detention Without Physical Examination) is handled by the FDA’s Division of Import Operations and Policy (known as DIOP, located at 5600 Fishers Lane, Room 12-38, Rockville, MD20857; (301) 443-6553). The topic is covered in the Regulatory Procedures Manual, Chapter 9, Subchapter titled Detention Without Physical Examination), heading of Removal from Detention Without Physical Examination: see page 9-25.

Requests for removal provided to the FDA’s DIOP should include a written explanation of the investigational steps taken to identify how the problem came about and a description of corrective actions taken, as well as copies of the private laboratory analysis and entry documentation for all of the entries cited as evidence that the problem has been corrected.

For fresh produce subject to DWPE for pesticide residues only, contact your monitoring FDA Compliance Officer to see if he or she can evaluate your exemption packet instead of DIOP.

If you submit an exemption packet you have three options about new entries while your packet is being evaluated: 1) Stop importing new entries of the product while you wait. 2) Offer new entries for import and request extensions for the testimony time period until the exemption packet review is completed; or, 3) Offer new entries for import and have them tested by the private laboratory also or otherwise overcome the appearance of the violation.

It is important to include in your request for exemption a statement that you request exemption fo9r any entries offered for import after you submit the packet. You should also state that the entries offered for import after you submitted the packet are compliance with all applicable FDA requirements.

10)What is Prior Notice? Do I have to provide it? How do I provide it?

Prior Notice is required for most food entries. If it is required, then it must be provided for the entry to clear FDA. Prior notice must be submitted electronically using CBP's ABI/ACS or FDA's PNSI. Both the CBP and FDA systems for prior notice are available 24 hours a day, 7 days a week for information submission.

See this webpage for an overview of Prior Notice:

See this webpage about filing Prior Notice:

11)What is an ‘Import for Export’ entry?

Import for Export is also known as IFE and refers to products that are violative and therefore not normally eligible for release. If these goods are going to be further processed in the US and then exported, they may be considered IFE if so declared and if multiple additional criteria are met. Some of these additional criteria include providing FDA certain data when offering the goods for entry. To learn more about IFE entries, see the FDA’s Regulatory Procedures Manual, Chapter 9, Imports, sub-chapter 9-15, Import For Export:

12)If my goods end up refused, can I sell them to another country?

An FDA Refusal means the goods have been rejected by FDA and are not allowed to be entered into US commerce. Refusal is a final decision made by FDA. Refusal triggers a demand for redelivery by CBP.

Redelivery means that you either destroy the goods or export the goods, per the CBP described process. If it is acceptable to CBP and to the receiving country, then, yes, you may satisfy the redelivery demand by exporting to any foreign country.

There is not a requirement that you export only to the country from which you imported.

13)I want to export my FDA regulated goods. Who can I contact for information about that?

Firms exporting food products from the United States are often asked by foreign customers or foreign governments to supply an "export certificate" for products regulated by the Food andDrug Administration (FDA). See and

FDA’s Office of International Programs serves as the agency focal point for interpretation and implementation of the provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that govern exports of unapproved, adulterated, or misbranded products and the FD&C Act provisions relating to the issuance of export certificates. See

14)Where do I go to find out information about FDA requirements for the products FDA regulates?

Here is the FDA's webpage of resources to assist industry organized by subject:

Also, here is a webpage with the contact information for the FDA’s Small Business Representatives:

* The information in this document was believed to be correct at the time it was developed. However, laws and regulations are subject to change. Always check for the most current information before proceeding on the basis of the information contained herein. This document does not convey any waive of responsibility to the firm, nor impart any immunity to the firm for violations that may occur, even if you implement our recommendations as per 21 CFR 10.85(k).