DETENTION WITHOUT PHYSICAL EXAMINATION OF RASPBERRIES FROM GUATEMALA

This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or product(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public.

NOTE: Revision to this Import Alert dated 01/05/2012 updates the background information and the Guidance section to include information regarding exemption from DWPE. Changes noted and bracketed by three asterisks (***).

In the spring of 1996 and 1997, there were numerous outbreaks of cyclosporiasis in the United States and Canada reported to FDA by the Centers for Disease Control and investigations and other data implicated fresh red raspberries from Guatemala. The geographical results of the investigations and data justified detaining all raspberries from Guatemala based upon the appearance of a violation.

During the spring of 1998 (March 15 through August 15), fresh raspberries from Guatemala were not allowed entry into the United States.

*** Review of this program in 2011 indicates Detention Without Physical Examination of fresh raspberries from Guatemala continues to be warranted.

Note: DWPE is not indicated for blackberries from Guatemala or for frozen raspberries from Guatemala.
***

Districts may detain without physical examination fresh raspberries (black, golden, red, or yellow) from Guatemala.

Farms listed in the Attachment to this import alert should not be subject to detention without physical examination for the reasons in this import alert. As other growers (farms) are determined not to be subject to physical examination, they will also be identified in the Green List of the Import Alert.

If a firm wishes to request removal from detention without physical examination, the firm should provide documentation with sufficient evidence that future shipments of their raspberries will not be adulterated. In addition, the firm should provide at least five consecutive, non-violative, commercial shipments over a period of time as part of the request for removal from DWPE.

In its request, the firm should forward information supporting its position to FDA to the following address:

Food and Drug Administration
Division of Import Operations and Policy
12420 Parklwan Drive
ELEM 3109
Rockville, MD 20857

Or via-email: Importalerts2@fda.hhs.gov

Requests for removal from detention without physical examination will be reviewed by DIOP and then referred to CFSAN for additional evaluation.

For questions or issues concerning import operations, contact DIOP Operations and Policy Branch at (301)796-0356.

For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at (301)796-6600.

Other questions may be directed to CFSAN, Office of Compliance, Product Adulteration Branch (HFS-606) at (240)402-2058

Fresh raspberries (black, golden, red, and yellow)

PROBLEM: Cyclospora

The article is subject to refusal of admission pursuant to Section 801(a)(1) of the Act in that it appears to have been manufactured, processed, or packed under insanitary conditions. [ADULTERATION, Section 402(a)(4)]

OASIS Charge Code: MFR INSAN