Import Alert 28-04

Import Alert # 28-04

Published Date: 02/21/2025

Type: DWPE

"Detention Without Physical Examination of Black and White Pepper from Brazil"

Note: The revision of this Import Alert (IA) dated 01/19/2023 updates the reason for alert, guidance section including agency contacts and product description have been updated. Changes to the import alert are bracketed by asterisks (***).

In 1980, the Center for Disease Control reported several incidents of Salmonella Kingabwa (Group U). The cause of the outbreaks was believed to be the consumption of spices or condiments from the Far East. ***Import Alert 28-04 was created on January 30, 1986, since data review continued to support Salmonella contamination of Brazilian pepper to be a problem.

Data review from FY 20 and FY 21 shows an average of 400 lines of Pepper from Brazil detained under IA 28-04. For FY 20 approximately 97% of those lines were reconditioning after the product was held for the appearance of Salmonella contamination. For FY 22 approximately 90% of those lines were reconditioning after the product was held for the appearance of Salmonella contamination.***

***Divisions may detain without physical examination, all shipments of black and white pepper in any form, (e.g., whole peppercorns, ground and crushed) from Brazil except those listed on the Green list.***

***Release of Articles Subject to Detention Without Physical Examination under This Import Alert:

In order to secure release of an individual shipment subject to DWPE under this import alert, the owner, consignee and/or other responsible party for the affected goods should provide evidence which demonstrates that the product does not contain Salmonella. Such evidence may include private laboratory analysis of samples.

Such evidence should be submitted to the appropriate FDA Division Compliance Office for consideration, per the notice of detention. If a private laboratory is used, further information regarding private laboratory analyses is found in FDA's ORA Lab Manual, volume III, section 7. Following receipt and review of analytical results, the FDA may, at its discretion, collect and analyze audit samples before rendering a final decision on the admissibility of the article. ***

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

In order to remove a firm from detention without physical examination (add to Green List), information should be provided to the Agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of a violation. The purpose of this is so the agency will have confidence that future entries will be in compliance with the FD&C Act. For guidance on removal from detention without physical examination, refer to FDA's Regulatory Procedures Manual, Chapter 9-8, "Detention Without Physical Examination (DWPE)."

If a firm and/or a representative thereof would like to petition for removal from detention without physical examination under this Import Alert (addition to Green List), all relevant information supporting the request should be forwarded to 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 OII Division of Import Operations (DIO) at (301) 796-0356 or Imports@fda.hhs.gov.

Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to FDAPRIVATELABIMPORTALERTS@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 the Human Foods Program Imports Enforcement Branch at HFP-OCE-Imports@fda.hhs.gov

  ***

***Black and white pepper (including whole peppercorns, ground, crushed or other forms.)***

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to
contain Salmonella, a poisonous and deleterious substance which may render it injurious to health."
[Adulteration, Section 402(a)(1)]

OASIS charge code - SALMONELLLA

Desc: Black pepper

Desc: Black pepper