9-10 - Reconditioning
9-10 - Reconditioning
To provide the districts with guidance for processing applications (Form FD-766) requesting authorization to bring detained merchandise into compliance.
Section 801(b) of the Federal Food, Drug, and Cosmetic Act provides that an importer of record (also the owner or consignee) may submit to the FDA a written application (Form FD-766) requesting permission to bring into compliance an article adulterated, misbranded, or in violation of Section 505 by relabeling or other action, or by rendering it other than a food, drug, device, or cosmetic. This Section also provides that the application should be covered by a bond for the payment of liquidated damages in the event of default. The approval of the application is at FDA's discretion.
Generally speaking, the owner or consignee (provided this firm or individual guarantees by a bond, proper custody and handling of the shipment) or their designated agent (i.e. customhouse broker, consultant, etc.) is the only one who has the legal right to submit an application to recondition or render the detained article not a food, drug, device or cosmetic. Under certain circumstances, the Importer (broker) or other designated agent authorized to act on the matter on behalf of the owner, or manufacturer (if it is a Rad. Health item) may also file an application, provided it is covered by a bond in the event of default. However, before approving an application submitted by the owner or consignee, the importer of record should be contacted to insure that he has no objection.
Frequently, applications are received from customhouse brokers or ultimate consignees who have not posted a bond covering the shipment. Such applications should not be considered and should be returned to the applicant with a notation that we can accept applications only from the importer of record, owner, or consignee, provided the application is covered by a good and sufficient bond, unless appropriate authorization to act on behalf of the owner in the matter has been provided to the district.
The Form FD-766 is essentially a four section form. A specimen copy of this form is attached as Exhibit 9-2 (front and back). A description of this form with additional comments is as follows:
Proposal Section
The applicant fills out the top portion (face page) of the form and submits it in triplicate (or quadruplicate) to the FDA district which issued the Notice of Detention and Hearing. A detailed description of the method by which the merchandise will be brought into compliance must be given. For example, such proposed methods as "fumigation and cleaning" are not adequate without the identity of the fumigant, method and duration of application, detailed description of cleaning, etc. In addition, the applicant should indicate the disposition of reject material. (Generally the application should provide for all information identified by Regulation 21 CFR Sections 1.95 and 1.96).
Action on Application Section
The "Action on Application" section of the form is used by FDA in either approving or disapproving the application. The original copy should be returned to the applicant with the first carbon copy to the district file and the second carbon copy forwarded to CBP for their information. If there is a third carbon copy, it should also be sent to the applicant.
If the district questions the adequacy of the proposed method, the matter should be referred to the appropriate headquarters center for evaluation and advice.
If past experience has shown that the proposed method will not succeed, the application should be disapproved. Applications should be approved only if it appears that the relabeling or other action will be successful and result in an acceptable product.
It is suggested that approved applications include the statement "MERCHANDISE SHOULD BE HELD INTACT PENDING THE RECEIPT OF FDA'S RELEASE NOTICE." Past experience has shown that reconditioned merchandise is sometimes distributed prior to FDA's determination of the adequacy of the reconditioning. In such cases, the applicant sometimes represents to CBP that he was not familiar with FDA procedures or that a third party (the actual reconditioner) was unsure of the procedures. Consequently, the inclusion of the aforementioned statement in the application is in FDA's best interest, if it later becomes necessary to recommend a bond action to CBP. It serves to formally advise the applicant of our procedures and his responsibilities and at the same time may discredit his petition in a bond action.
If the proposal involves a reconditioning of an adulterated product where the sanitary condition of the equipment and facilities is a critical factor, the district should not approve the application until the condition, that FDA be notified within a specified time before the start of the reconditioning to enable us to inspect the reconditioning firm, is added by the applying party. An example of such a situation would be the reconditioning of insect contaminated spices where the cleaning of the product under insanitary conditions would adulterate the article under Section 402(a)(4) of the Act.
Applications should not be "approved with the following condition." If there are conditions which we feel should be covered in the proposed procedure it should be denied and inform the applicant that we will reconsider another application if the matter is covered. Past experience has shown that on occasion the applicant either does not agree with or fails to see or understand the conditions which results in much confusion and many problems. By denying the application because of the failure to cover all areas and suggesting resubmission of another proposal to resolve it, the applicant can neither say he did not see, understand or agree to it for he is proposing it. For example, an application should be denied when the matter of rejects has not been resolved. If the applicant fails to propose an acceptable disposition of rejects, the application should be denied; inform the applicant of the reason for denial on the Form FD-766 and suggest that a new application which includes disposition of rejects will be considered. Only minor points, such as date of completion, etc. should be specified under the "approved with the following condition".
Importer's Certificate Section
The "Importer's Certificate" section of the Form FD-766 is used by the applicant to advise FDA that the relabeling or other action has been completed and that the goods are ready for inspection/sample collection. In making this certification, the applicant should fill-in the original copy of the application which was returned to him (as described in RPM page 431, "Action on Application Section", above) and then submit the application to FDA.
Report of Inspector Section
This "Report of Inspector" section of the form FD-766 is used by the examining FDA or CBP official. This section is later used by the designated district office in preparing the charge sheet and the subsequent Release Notice or Notice of Refusal of Admission.
Any changes at any time by the applicant in the reconditioning proposal must be made by the filing of an amended application and must be approved by FDA. Granting of verbal requests for changes may result in misunderstandings and may create problems if it becomes necessary to initiate bond action against the applicant at a later date.
At times the applicant cannot complete the reconditioning operation within the specified time period. Additional time may be granted by the district upon a written request from the applicant and the showing of reasonable grounds.
Requests for extensions of unduly long periods should not be granted, as the possibility of accidental or intentional diversion and additional adulteration of the shipment increases with the time factor. Normally, a second request for an extension of time should not be granted unless the applicant shows compelling reasons to do so.
At times the applicant is not successful in the reconditioning of an adulterated shipment, particularly in cases where the product is contaminated with filth (insects, rodent excreta pellets, etc.). Permission should not be granted for a second attempt at reconditioning without the benefit of another application (Form FD-766).
The applicant may submit a second application if he so desires. However, this application should not normally be approved unless it contains meaningful changes in the reconditioning operation to insure a reasonable chance at success. A second application should not be approved if it merely is a resubmission of the original application.
In approving a second application, the district should include in the "ACTION ON APPLICATION" section of the application the statement "IF THIS ATTEMPT AT RECONDITIONING DOES NOT BRING THE MERCHANDISE INTO COMPLIANCE FUTURE APPLICATIONS TO DO SO MAY NOT BE CONSIDERED."
Request for a third attempt at reconditioning generally should not be granted. It is our opinion that to allow unlimited attempts at reconditioning only encourage importers to import grossly adulterated merchandise into the U.S.
If the applicant is not able to recondition a shipment to FDA's satisfaction, a Notice of Refusal of Admission should be issued in the usual manner. See RPM page 429, "Refusal of Admission." If FDA supervisory charges are involved, a Form FD-790 should be issued. See RPM page 434, "Supervisory Charges."
Relabeling of New Drugs
At times an importer of record may desire to bring a drug shipment detained on a new drug charge into compliance by revising the labeling to remove claims which placed the product into the category of a new drug. Sometimes such a drug appears to be composed of harmless ingredients. A typical example is Chinese herbal medications labeled for the promotion of blood circulation, sexual rejuvenation, headaches, anemophobia, back neuralgia, bone pain, acute or chronic neuralgia and other pain caused by rheumatism.
Do not permit the relabeling of a drug detained on a new drug charge as a means to bring the item into compliance. To do otherwise is not in the best interest of the consuming public. Experience has shown that such drugs may contain undeclared ingredients, such as phenylbutazone and aminopyrine, which present serious hazards to the users. Likewise, it should be noted that any drug seized in domestic commerce on a new drug charge cannot be relabeled and introduced into commerce, but if condemned by the court must be destroyed.
Reconditioning of Green Coffee and Cocoa Beans Due to the Presence of Live and/or Dead Insects
This procedure was originally instituted for reconditioning green coffee beans detained under Administrative Guideline 7403.01 due to the presence of live and/or dead insect infestation (CPG 510.500). The procedure has now been expanded to include cocoa beans (CPG 515.750).
In the past when green coffee beans were detained for live and/or dead insect infestation, the importer of record submitted an Application for Reconditioning (FD-766) indicating fumigation and cleaning prior to delivery to the roasting plant. The coffee industry contended that part of the processing of coffee beans at most roasting plants includes a cleaning procedure for removal of dead insects and extraneous material. The cleaning and rebagging before processing purportedly causes duplication of cleaning and results in additional charges for the importer and ultimately for the consumer.
To avoid duplication the following alternate reconditioning procedure can be used if the importer chooses.
After a detention due to live insect infestation is issued, the importer of record or consignee must submit an Application for Reconditioning (FD-766). The FD-766 shall identify the procedure for fumigation (including name and amount of fumigant, time of exposure etc.) which is to be used. The application shall also include 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. When it is deemed necessary, for monitoring purposes, the FD-766 should be approved with the condition that rejects (tailings) are to be held for FDA examination and subsequent destruction under U.S. CBP or FDA supervision.
As part of the approval of this application (FD-766) the fumigation must be accomplished prior to permitting the lot's movement to the roasting plant. The district, at its discretion, may examine the lot to determine the effectiveness of the fumigation. If the stated date or time of cleaning has to be changed, the importer should notify the district supervising the reconditioning at least 72 hours prior to the time noted in the application.
At the time of the initial submission of the FD-766 application under this procedure, the file should be checked to determine if there has been a recent inspection of the cleaning facility. If not, the application should be approved with the condition that the roasting plant will be inspected to determine if it is acceptable to FDA prior to the movement of the beans to that plant. If the plant is found acceptable, the district will advise the importer that the lot may be sent to the roasting plant. Inspections should be made without undue delay to avoid causing importers excessive storage charges.
After the initial inspections the districts, at their discretion, may make follow-up inspections to determine if the plants' cleaning operations are being maintained to properly recondition detained lots.
All time to conduct inspections to determine if the processors plant and equipment is acceptable and those made to check on specific lots after reconditioning shall be included in the supervisory charges issued to the importer of record. All movement of detained lots shall be under CBP's bond and by acceptable conveyances.
The procedure outlined above, is to be used, with the exception of the fumigation procedure, when the detention is for dead insect infestation only. As previously stated this procedure is not to be accepted when the detention is for insect damaged and/or moldy coffee beans.
Reconditioning of Biologicals
Unlicensed biologicals or biologicals without an effective IND which were refused admission are not subject to reconditioning except in the instances where the intended use of the product is changed to render the product a non-biological, non-drug product, and is so reflected in the associated labeling. Center for Biologics Evaluation and Research (CBER) concurrence with any reconditioning application for a biological product is required.
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