Import Alert 34-01

(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(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).

Import Alert # 34-01
Published Date: 08/25/2020
Type: DWPE

Import Alert Name:

"Detention Without Physical Examination of Cocoa Beans From Brazil, Indonesia and Malaysia Due to Presence of Live Insects"

Reason for Alert:

NOTE: The revision to this import alert dated 8/25/2020 updates the name of the alert, the Guidance section to add release, removal, contact information, product codes, and charge verbiage. Changes are bracketed by asterisks (***).

During the first six months of FY91, the former BLT-DO detained 44 out of 57 shipments of cocoa beans from Brazil for live insect infestation (77% violation rate). These 44 detentions represented 9 Brazilian shippers.

During this same timeframe, the former BLT-DO detained 144 out of 149 shipments of cocoa beans from Indonesia for live insect infestation (96% violation rate). These detentions represented 17 Indonesian shippers.

Additionally, during this same period, the former BLT-DO detained 70 out of 122 shipments of cocoa beans from Malaysia for live insect infestation (57% violation rate). These detentions represented four shippers.

Results were obtained using Macroanalytical Procedures Manual (MPM) method V-18.

Guidance:

***Divisions may detain, without physical examination, all shipments of cocoa beans from Brazil, Indonesia, Malaysia, which are not listed on the Green List of this alert.

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

In order to secure release of an individual shipment identified for DWPE under this import alert, the owner or consignee of the affected goods should provide the results of a private laboratory analysis of a representative sample(s) collected from the affected article as evidence that the product does not contain live insects at a level that is determined to be filthy within the meaning of Section 402(a)(3) of the Federal Food, Drug & Cosmetic Act.

Sampling recommendations for private laboratory sample collections: Collect at least ten (10) representative subsamples from each lot within the shipment. Each subsample should contain one (1) pound of beans composited by taking approximately one third (1/3) from each of three (3) bags or other containers in the lot. For more information about sample preparation and analysis refer to MPM V-4A Method for Cocoa Beans (V-18).

Resources for private laboratory testing are available at: https://www.fda.gov/science-research/field-science-and-laboratories/private-laboratory-testing

Proper sampling and analytical records should be submitted to the appropriate FDA Division compliance office for consideration per the notice of detention. For further information regarding private laboratory analyses, please reference FDAís ORA Lab Manual, volume III, section 7. Following receipt and review of private laboratory 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 add a firmís product to the Green List of this Import Alert, information should be provided to the Agency to adequately demonstrate that the manufacturer has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so that the Agency will have confidence that future shipments/entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act).

For guidance on removal from detention without physical examination, refer to FDAís Regulatory Procedures Manual (RPM), 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, 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 ORA/DIO (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov.

Questions or issues involving OASIS or PREDICT screening should be addressed to ORA/DSS/Import Systems Branch at oraoismdssimpcomplsysbr@fda.hhs.gov.

Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to ORA/Office of Regulatory Science at oraorsprivatelabimportalerts@fda.hhs.gov.

Questions or issues with regard to human food on policy, sample collection recommendations, or any additional questions, should be addressed to CFSAN/Division of Enforcementís Food Adulteration Assessment Branch at (240) 402-1750 or CFSANEnforcement@fda.hhs.gov.***

Product Description:

Cocoa Beans

Product Code: ***34A[][][]***

Charge:

***The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food. *** [Adulteration, Section 402(a)(3)]

OASIS CHARGE CODE: FILTHY

Countries

BRAZIL

  • (34 A - B 99) Cocoa Bean N.E.C., Raw, Fresh, Ambient
    Desc: cocoa beans
  • (34 A - - --) Cocoa Bean
    Desc: COCOA BEANS

INDONESIA

  • (34 A - B 99) Cocoa Bean N.E.C., Raw, Fresh, Ambient
    Desc: cocoa beans
  • (34 A - - --) Cocoa Bean
    Desc: COCOA BEANS

MALAYSIA

  • (34 A - B 99) Cocoa Bean N.E.C., Raw, Fresh, Ambient
    Desc: cocoa beans
  • (34 A - - --) Cocoa Bean
    Desc: COCOA BEANS

List of firms and their products that have met the criteria for exclusion from Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Green List)


INDONESIA


PT. Bening Big Tree Farms
Date Published : 10/15/2014
Banjar Piakan, Sibangkaja, Abiansemal , Badung, ID-BA INDONESIA
34 A - - 99 Cocoa Bean N.E.C.
Date Published: 10/15/2014

Desc: Cocoa Beans

PT. GEMILANG JAYA MAKMUR ABADI
Date Published : 03/07/2012
Jl Raya Mondoroko 135 , Malang, Jawa Timur INDONESIA
34 A - - 99 Cocoa Bean N.E.C.
Date Published: 03/07/2012

Desc: Cocoa Beans