Law Library

U.S. Food and Drug Administration
Center for Food Safety & Applied Nutrition
Industry Affairs Staff Flyer: 1996


      FDA IMPORT PROCEDURES

 

 

1.   Importer  or  agent  files  entry   documents  with  U.S.

     Customs  Service within five working days of the date of

     arrival of a shipment at a port of entry.

 

2.    FDA is notified of an entry of a regulated food through:

 

     -    Duplicate copies of Customs Entry Documents (CF 3461,

          CF 3461 ALT, CF 7501 or alternative),

 

     -    Copy of commercial invoice, and,

 

     -    Surety to cover potential duties, taxes and penalties.

 

3.   FDA reviews Importer's Entry  Documents

     to determine if a physical examination, wharf examination,

     sample examination should be made.

 

4A.  Decision is made not to collect a sample. FDA sends a "May

     Proceed Notice" to U.S. Customs and the importer of record.

     The shipment is released as far as FDA is concerned.

 

4B.  Decision is made to collect a sample based on:

 

        -  Nature of the product,

 

        -  FDA priorities, and,

 

        -  Past history of the commodity.

 

     FDA sends a "Notice of Sampling"  to U.S.

     Customs and the importer of record.  The shipment must be

     held   intact pending further notice. A sample will be

     collected from  the  shipment.   The importer of record may

     move the shipment   from the dock to another port or

     warehouse (contact  U.S.  Customs for details).

 

5.   FDA obtains a physical sample.  The sample is sent to an

     FDA District Laboratory for analysis.

 

6A.  FDA analysis finds the sample to be in compliance with

     requirements.  FDA sends a Release Notice

     to U.S. Customs and the importer of record.

 

6B.  FDA analysis determines that the sample "appears to be in

     violation of the FD&C Act and other related Acts."    FDA

     sends U.S. Customs and the importer of record a Notice of

     Detention and Hearing  which:

 

      -   Specifies the nature of the violation, and,

 

      -   Gives the importer of record 10 working days to

          introduce testimony as to the admissibility of the

          shipment.

 

     The hearing is the importer's only opportunity to present a

     defense of the importation and/or to present  evidence as to

     how  the shipment may be made eligible for entry.

 

7A.  Consignee, true owner, importer of record, or a designated

     representative responds to the Notice of Detention and

     Hearing.  The response permits the introduction of

     testimony, either orally or written, as to the

     admissibility of the shipment.

 

7B.  Consignee, true owner, importer of record, or a designated

     representative neither responds to the Notice of Detention

     and Hearing nor requests an extension of the hearing period.

 

8A.  FDA conducts a hearing concerning the admissibility of the

     product.  The hearing is an opportunity to present relevant

     matters and is confined to the submission of pertinent

     evidence.

 

8B.  FDA issues a Notice of Refusal of Admission to the importer of

     record.  This is the same person or firm who was sent a Notice

     of Sampling.  All recipients of the Notice of Sampling and the

     Notice of Detention and Hearing are sent a copy of the Notice

     of Refusal.

 

9A.  Importer of record presents evidence indicating that the

     product is in compliance.  Certified analytical results of

     samples, examined by a reliable laboratory and which are

     within the published guidelines for levels of contaminants

     and defects in food for human use, may be presented.

 

9B.  Importer of record submits an Application for Authorization

     to Recondition or to Perform Other Action (FDA Form FD 766).

     The form requests permission to try to bring a food that is

     adulterated or misbranded into compliance by relabeling or

     other action, or by converting to a non-food use.  A

     detailed method to bring the food into compliance must be

     given.

 

9C.  FDA receives verification of the exportation or destruction

     of the shipment from U.S. Customs.  The exportation or

     destruction of the merchandise listed on the Notice of

     Refusal of Admission is carried out under the direction of

     U.S. Customs.

 

10A. FDA collects follow-up sample to determine compliance with

     guidelines.

 

10B. FDA evaluates the reconditioning procedure proposed by the

     importer.  A bond is required for payment of liquidated

     damages.

 

11A. FDA finds that the sample is "in compliance."  A  Release

     Notice with the statement "Originally Detained and Now Released" is sent to

     U.S. Customs and the importer.

 

11B. FDA finds that the sample is not in compliance.  The

     importer may either submit an Application for Authorization

     to Recondition or to Perform Other Action (see  9B), or, FDA

     will issue a Notice of Refusal of Admission (see 8B).

 

11C. FDA approves importer's reconditioning procedures.  The

     approved application contains the statement "Merchandise

     Should Be Held Intact Pending the Receipt of FDA's Release

     Notice."

 

11D. FDA disapproves applicant's reconditioning procedure if

     past experience shows that the proposed method will not

     succeed.  A second and final request will not be considered

     unless it contains meaningful changes in the reconditioning

     operation to ensure a reasonable chance of success.  The

     applicant is informed on FDA Form FD 766.

 

12.  Importer completes all reconditioning procedures and advises

     FDA that the goods are ready for inspection/sample

     collection.

 

13.  FDA conducts follow-up inspection/sample collection to

     determine compliance with the terms of the reconditioning

     authorization.

 

14A. FDA analysis finds that the sample is in compliance. A

     Release Notice is sent to the importer and to U.S. Customs.

     The charges for FDA supervision are assessed on FDA Form FD 790.

     Copies are sent to U.S. Customs which is responsible for obtaining

     total payment including any expenses incurred by their personnel.

 

14B. FDA analysis finds that the sample is still not in

     compliance.  Charges for FDA supervision are assessed on FDA

     Form FD 790.  Copies are sent to U.S. Customs which is

     responsible for obtaining total payment including  expenses

     incurred by their personnel.

 

 

 

 

IMPORTERS CAN SPEED FOOD ENTRIES!

 

 

 

     -    Determine before shipment that the product to be

          imported is legal.

 

     -    Have private laboratories examine samples of foods to

          be imported and certify the analysis of the processor.

          While not conclusive, these analyses might serve as an

          indication of the processor's ability to produce

          acceptable, legal products.

 

     -    Become acquainted with FDA's legal requirements, before

          contracting for a shipment.

 

     -    Request assistance from the FDA District Office

          responsible for your port of entry.

 

     -    Know the food importing procedures described on this

          information sheet.


01/18/97