DETENTION WITHOUT PHYSICAL EXAMINATION OF RASPBERRIES FROM GUATEMALA

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. Cyclospora cayetanensis is a human-specific protozoan parasite that causes a prolonged and severe diarrheal illness known as cyclosporiasis. Cyclospora is endemic to Guatemala, with highest incidence of disease occurring in the summer months. Infection of food most commonly occurs when food or water becomes contaminated with feces. The geographical results of the investigations and data justified detaining all raspberries from Guatemala during March 15 through August 15 of every year.

Fresh raspberries from Guatemala are not allowed entry into the United States during the time period specified above, unless the firm appears on the Green List of this import alert.

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 shipments of fresh raspberries (black, golden, red, or yellow) from Guatemala offered for entry from March 15 through August 15 of every year.

Fresh raspberries from Guatemala offered for entry at other times of the year are not considered subject to detention without physical examination.

Firms listed on the Green List of this import alert should not be subject to detention without physical examination for the reasons in this import alert. As other firms 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 to show the following:

1.Information demonstrating that the conditions or practices that gave rise to the appearance of a violation have been resolved.

and

2.Evidence that future entries will be in compliance with the Federal Food, Drug, and Cosmetic Act.

To enable FDA to assess the adequacy of the firms agricultural, processing and transportation practices, it would assist FDA if firms addressed their practices in the following areas to the extent that they apply to the prevention of contamination of raspberries with Cyclospora:

Safety of water used in irrigation, packing and cooling;
Worker health and hygiene;
Sanitary facilities in field and packing house, and disposal of sewage;
Maintenance program for cleaning, sanitizing equipment;
Field and packing facility sanitation;
Steps taken to identify and correct insanitary conditions.

Results of laboratory analysis conducted to assess ongoing implementation of a firm¿s preventive controls should be included with the documentation submitted to FDA. Further details and examples of the types of information that would be helpful to FDA in its assessment can be found in FDA¿s Guidance for Industry Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables (October 26, 1998) and FDA¿s Final Guidance: Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables (February 2008).

After reviewing these submissions, FDA, either solely or in conjunction with the relevant Guatemalan regulatory authority, may conduct a limited number of on-site inspections of the growing/processing areas to audit the validity of the information submitted to FDA.

Requests for removal from detention without physical examination should be sent to FDA at the following address:

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

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

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, Food Adulteration Assessment Branch, (HFS-607) at (240)402-2772

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