Import Alert 20-04

Import Alert # 20-04

Published Date: 11/18/2022

Type: DWPE

Detention Without Physical Examination Of Raspberries From Guatemala Due To Cyclospora Cayetanensis

NOTE: The revision of this Import Alert, dated 11/18/2022, updates the alert to include a title change, additional guidance on removal from detention without physical examination under this import alert, updated PAF and current Agency contact information. Changes are bracketed by asterisks (***).

In the spring of 1996 and 1997, there were numerous outbreaks of cyclosporiasis in the United States and Canada. Epidemiological and traceback investigations implicated fresh red raspberries from Guatemala.

*** Cyclospora cayetanensis (C. cayetanensis) is a human gastrointestinal parasite which causes cyclosporiasis. Humans are the only known host for this parasite. This parasite can cause protracted diarrheal illness in both immunocompetent and immunocompromised humans. People can become infected with C. cayetanensis by consuming food or water contaminated with the parasite. Infected people shed unsporulated (non-infective; immature) C. cayetanensis oocysts in their stool; immature oocysts usually require at least 1-2 weeks outside the host under favorable conditions to sporulate and become infective. Therefore, transmission of C. cayetanensis from person-to-person is unlikely. C. cayetanensis is endemic to Guatemala, with highest incidence of disease occurring in the summer months. The results of outbreak investigations justified detaining all raspberries from Guatemala during March 15 through August 15 of every year. Therefore, FDA believes this import alert continues to be an important part of our cyclosporiasis prevention program.***

*** Divisions 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 except those firms listed on the Green List of this import alert.

Fresh raspberries from Guatemala offered for entry at other times of the year are not considered subject to detention without physical examination (DWPE). Additionally, DWPE is not indicated for blackberries or for frozen raspberries from Guatemala. ***

*** Removal from Detention without Physical Examination (ADD TO GREEN LIST):

Since the article is subject to Refusal of Admission per Section 801(a)(1) of the Act, FDA considers submission of analytical results indicating the absence of C. cayetanensis to be insufficient to overcome the appearance the product has been prepared, packed, or held under insanitary conditions. In addition, the appearance of a violation per Section 801(a)(1) of the Act precludes reconditioning under Section 801(b) of the Act.

If a firm or their representative would like to request removal from DWPE, FDA recommends that your submission include documentation that you have implemented practices, processes, and procedures that prevent contamination of raspberries with C. cayetanensis from:

- Water. When used in contact with raspberries for irrigation, crop protection sprays, packing, and cooling. If you rely on testing for indicator organisms, such as generic E. coli, for the adequacy of your water, samples must be taken from untreated water in order to be considered as evidence that the water is not a potential source of C. cayetanensis;
- Workers. You may include evidence of worker training and monitoring of worker health and hygiene;
- Latrines and hand washing stations. You may include information on how latrines are maintained, cleaned, and located to prevent contamination of raspberries in the field and packing operations. May also include methods of disposal of cleaning water and sewage; and
- Equipment and tools. Harvesting and packing equipment that may come into contact, directly or indirectly with raspberries. May include information on proper cleaning and maintenance of tools and equipment.

In the past some firms submitted evidence of addition of lime (calcium hydroxide) as evidence that they are controlling the hazard of C. cayetanensis associated with spills from latrines. Others have cited the addition of chlorine to demonstrate that their water is safe. FDA is unaware of evidence demonstrating that lime or antimicrobials are effective against C. cayetanensis. If you rely on chemical or physical treatments for water or sewage, you may wish to include scientific support for the validity of those treatments.

Requests for removal from DWPE will be evaluated by DIO and referred to the CFSAN Office of Compliance, Division of Enforcement for review.

*** To facilitate our review of your submission, we recommend that you send all documents, except copies of original records, in English.

Guidance: Additional guidance may be accessed on FDA's website, www.fda.gov. Firms may wish to refer to FDA's guidance, "Cyclosporiasis and Fresh Produce" and "Draft Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption."

For additional guidance on removal from DWPE, refer to FDA's Regulatory Procedures Manual, Chapter 9-8, "Detention without Physical Examination (DWPE)." 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
12420 Parklawn Drive
ELEM 3109
Rockville, MD 20857

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

*** Questions or issues involving import operations should be addressed to ORA/DIO/Import Operations Branch (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov

Questions or issues with regard to human food on policy, sample collection recommendations, or any additional questions not directly related to a detained entry, should be addressed to CFSAN/Division of Enforcement's Food Adulteration Assessment Branch at CFSANEnforcement@fda.hhs.gov

                                                                                                                                                                 ***

***Fresh Raspberries (black, golden, red, and yellow)***

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

Desc: Raspberries

Notes: Problem(s); Firm changed name from Planesa S.A. to Special Fruits and Vegetable Exports; S.A.

Desc: Raspberries

Notes: Problem(s); Firm changed name from Planesa S.A. to Special Fruits and Vegetable Exports; S.A.

Desc: Raspberries

Notes: Problem(s); Firm changed name from Planesa S.A. to Special Fruits and Vegetable Exports; S.A. ;

Desc: Raspberries

Notes: Problem(s); Firm changed name from Planesa S.A. to Special Fruits and Vegetable Exports; S.A. ;

Desc: Raspberries

Notes: Problem(s); Firm changed name from Planesa S.A. to Special Fruits and Vegetable Exports; S.A. ;

Desc: Raspberries

Notes: Problem(s); Firm changed name from Planesa S.A. to Special Fruits and Vegetable Exports; S.A. ;