DEPARTMENT OF HEALTH & HUMAN SERVICES
November 1, 2012
Executive Vice President
National Confectioners Association's Chocolate Council
1101 30th Street NW, Suite 200
Washington, DC 20007
Dear Ms. Bodor:
This letter is a follow-up to our May 14, 2012, meeting and associated communications with you, the Chocolate Merchants Association of America, and the Intercontinental Exchange regarding FDA's approach to the reconditioning of imported cocoa beans that are detained because of the apparent presence of live insects or filth.
FDA's Regulatory Procedures Manual1 describes two acceptable methods for reconditioning imported cocoa beans subject to insect or related filth in order to bring the product into compliance with the Federal Food, Drug, and Cosmetic Act. These are summarized below:
Method 1: The importer of record or consignee submits an Application for Reconditioning (FD-766) indicating fumigation and cleaning prior to delivery to the roasting plant.
Method 2: The importer of record or consignee submits an Application for Reconditioning (FD-766) identifying the procedure for fumigation (including name and amount of fumigant, time of exposure, etc.) that is to be used; the name and address of the roasting plant where the cleaning phase will be accomplished; the identity of the equipment to be used in the cleaning operation; the date and time cleaning operations are to begin; and that a signed statement will be submitted to FDA attesting that the reconditioning was properly carried out by the processor when the entire reconditioning has been completed.
FDA has tentatively concluded that the following procedure is also acceptable for reconditioning these products, effective November 1, 2012:
Method 3: The importer of record or consignee submits an Application for Reconditioning (FD-766) identifying the procedure for fumigation (including name and amount of fumigant, time of exposure, etc.) that is to be used. The fumigation is carried out prior to the lot being moved to storage or for further processing. The importer of record or consignee also includes the following statement:
I certify that I will either clean the goods myself during their processing in accordance with standard industry practice, or I will ensure that any contract for sale of the goods will require such cleaning by the ultimate purchaser.
FDA would review the reconditioning proposal and authorize the proposal if the agency determines it to be acceptable. FDA would release the shipment based on the importer of record or consignee's actions carried out in accordance with the proposal as well as their certification that the product will be cleaned.
We have tentatively concluded that this method is acceptable based on factors and information specific to this situation. For example, the cleaning of cocoa beans for dead insects and filth is a standard part of the normal processing of the otherwise inedible raw cocoa beans that turns them into roasted cocoa beans for further manufacturing. The cocoa/chocolate industry carries out multiple cleaning steps as a matter of standard practice during the processing of cocoa beans, including removing foreign materials and other debris, removing the shells/dehulling, and incinerating any remaining evidence of filth during roasting. These cleaning activities occur regardless of whether the firm cleans the cocoa beans as part of a reconditioning plan.
The importer of record or consignee can choose among the above methods for reconditioning, or can propose an alternative to FDA that the importer of record or consignee believes would successfully recondition the product.
We believe that these methods for the reconditioning of cocoa beans will facilitate the entry and movement of raw cocoa beans while providing sufficient safeguards to ensure adulterated product does not reach consumers. Nonetheless, FDA plans to evaluate the new process for reconditioning to verify that the cocoa beans are being sufficiently cleaned. This review will help FDA determine whether it should be revised or discontinued.
Should you have questions or comments, please contact Mr. John Verbeten, Director of the Division of Imports at (301) 796-6677.
Michael M. Landa
Director, Center for Food Safety and Applied Nutrition
Melinda K. Plaisier
Acting Associate Commissioner for Regulatory Affairs