Inspections, Compliance, Enforcement, and Criminal Investigations
9-13 - Import Information Directives
To identify and disseminate import information (problems, violative trends, etc.) for providing an effective import coverage program.
To formalize the procedures for initiating, preparing, clearing, issuing, revising, and canceling import information directives (Import Alerts and Import Bulletins).
Prior to 1972, FDA had no formal system to disseminate import problem information, although Import Circulars were occasionally issued for that purpose. FDA's coverage of imported products was often conducted on a district-by-district basis, resulting in less effective consumer protection.
A formal system known as Import Alert Procedures was established in 1972. Import Alerts replaced the Import Circulars. Detailed guidance for initiation, preparation, clearance, issuance, revision, and cancellation of alerts has been added in this latest RPM revision.
The FDA Import Alert Retrieval System (FIARS) was made operational in August 1987. FIARS is a computerized format for Import Alerts and Bulletins, enabling users to search for an alert or bulletin by keyword or full text search. The FIARS program resides on the district VAXs and is updated by Division of Import Operations, (DIO) after new alerts or bulletins are issued by EMS.
Import information directives consist of the following documents issued by the DIO:
- 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 detention without physical examination (see RPM subchapter 9-6 for discussion of detention without physical examination).
- Import Bulletins are generally informational only. While the information may identify possible problems, bulletins may not provide policy or coverage guidance, although in some cases sample collections will be advised.
Import alerts significantly improve the uniformity of enforcement in import problem areas. Import alerts may have a significant impact on national and international economic and trade matters.
Initiating an Import Alert
New import alerts may be proposed by the field, the centers, or any other headquarters unit. Recommendations for import alerts should have the concurrence of the appropriate management of the requesting unit.
Submit recommendations for import alerts to the Division of Import Operations (DIO). Include the following information in the recommendation memorandum:
- Purpose of the import alert.
- All pertinent background information such as sample results, violation rates or trends, etc.
- The national significance of the problem (health hazard, etc.).
- The volume of entries, number of importers, foreign shippers, countries involved, other product information such as whether it is seasonal in nature, etc.
- An accurate and complete description of the product, including its packaging and how it is to be stored.
While not required, the submission of a proposed draft of the import alert with the recommendation is highly recommended. FIARS guideline document #00-05, provides the import alert format.
After review, DIO will prepare a clearance package containing an import alert draft, the form FD-2306 (Clearance Record), and any other pertinent information. If the data is incomplete or insufficient the initiator of the draft will be advised.
Import Alert Clearance Procedures:
DIO is responsible for proper clearance and issuance of import alerts. The clearance package will be sent to the appropriate center, Office of Operations (OO), and Office of Chief Counsel for clearance and the Office of Regulatory Science (ORS) and the Office of Enforcement and Import Operations (OEIO) as necessary. If revision is necessary, the package should be returned to DIO for correction. Upon clearance, DIO will issue the alert via electronic mail service (EMS), load the alert into the Compliance Management System (CMS) and provide appropriate screening in the national entry database.
Every effort should be made to expedite clearance of import alerts. Each clearance point should attempt to review and clear each alert within 2 days. Import alerts involving health hazards should be hand- carried to the next clearance point and/or telephone clearance should be obtained.
When clearance delays are encountered, clearance units should inform DIO (301-796-0356). Upon approval, DIO will issue the import alert via electronic mail.
Review of Import Alerts
As conditions permit, all import alerts over two years old will be reviewed semi-annually by DIO to determine whether they are current. This review will include an evaluation of detention activity for the previous one year period, the health significance of the problem, etc. When the evaluation so indicates and the Centers agree the alert will be deleted or revised as needed.
Import Alert Filing Procedure
Import Alerts will be numbered within industry code (i.e., import alerts dealing with seafood begin with industry code "16").
DIO will issue Import Bulletins on an as-needed basis. Bulletins are usually advisory only and may not disseminate policy or procedures. They will issue on the responsibility of DIO. They will be numbered chronologically within Industry Code preceded by "B" (16-B01, etc.). Import Bulletins are generally valid for 90 days after issuance. Any information from field or headquarters units which falls into this category may be forwarded for consideration as an Import Bulletin.
DIO will review Import Bulletins to see if information has developed which indicates the need for an alert. If districts develop such information they should notify DIO.