Agenda Item 5.4 | Conference Room Document 21 English only |
second fao/who global forum of food safety regulators
Bangkok, Thailand, 12-14 October 2004
(Prepared by the Philippines)
This document details the response mechanism to intentional contamination of food in the Department of Health (DOH), Philippines. The mechanism is primarily implemented by the Bureau of Food and Drugs (BFAD) which is the key regulatory agency of the DOH to ensure safety, efficacy, and quality of food products. There is no established mechanism on the prevention of intentional contamination of foods.
Bureau circular No. 8 series of 2001 of the Bureau of Food and Drug (BFAD) provides guidelines to be observed on the implementation of the Product Recall System. This circular was promulgated in support of a law called Republic Act 3720 as amended, or otherwise called the "Foods, Drugs, Devices and Cosmetics Act" which declares it the policy of the state "to ensure safe and good quality supply of food, drugs and cosmetics and to regulate the production, sale and traffic of the same to protect the health of the people".
The circular stipulates that product recalls can be initiated by the manufacturers and distributors of a violative product on their own initiative or in response to a recall order by the BFAD. Products which present a risk of injury to the general public or manifesting gross deception (such as those with erroneous labelling) are subject to recall. Recalls are classified as follows:
The recall process begins with the filing of a case report or notification regarding the product in question. Such case report may come from the responsible company (company-initiated), BFAD technical divisions, DOH or other government offices, or consumer complaints. The report should provide the following information, if it is a company initiated recall:
The BFAD Committee for Product Recall, upon receipt of a case report, will assess the hazard presented by a product being recalled or considered for recall. Health hazard evaluation will take into account the following factors among others:
The committee will submit a written recommendation to the BFAD director for the issuance of a recall order or to confirm a company initiated recall.
The BFAD director then orders a firm to initiate a recall upon the recommendation of the BFAD Committee for Product Recall. If the case report is not company-initiated, the notification from the BFAD director shall contain the following information:
The concerned DOH offices will be informed of the decision to order product recall. A public health alert will be issued within twenty-four (24) hours for the purpose of alerting concerned populations to either serious health hazards or other situations deemed to be in the public interest. The type of public health alert used will depend on the product's recall classification:
If recall is not firm-initiated, a notification will be issued to the firm regarding the recall recommendation together with a request for the submission of recall plan/procedure and other information. A recall strategy suitable for individual recall circumstances shall be developed by the BFAD and/or the recalling firm. The following elements shall be included in a recall strategy:
In developing a recall strategy, the duration to complete the recall operation should also be considered. Completion of a recall operation should be within the following recommended period:
An in-depth inspection of responsible establishment/production facilities where the violation occurred will be conducted by the concerned inspection division of the BFAD. If necessary, other DOH units and government agencies will be utilized in implementing the recall. The concerned BFAD inspection division will audit the recall operation by developing and implementing a recall audit program. In case the concerned firm refuses to conduct a product recall, regulatory action and/or other measures will be pursued by BFAD.
The recalling firm is mandated to submit product recall status reports to the BFAD so that the agency may assess the progress of the recall. The frequency of such reports will be determined by the relative urgency of the recall and will be specified by the BFAD in each recall case; generally the reporting interval will be between 2 and 4 weeks. The recall status report should contain the following information:
The BFAD will determine when a recall will be terminated and upon such determination, provide written notification of the termination to the recalling firm.
Seizure, multiple seizures or other court action shall be undertaken by the BFAD when a firm refuses to conduct a recall ordered by BFAD, or where the agency has reason to believe that a recall would not be effective, determines that a recall is ineffective, or discovers that a violation is continuing.
Products which have been subject of a recall must immediately be removed from the market and must not be allowed for distribution and sale. Upon completion of the recall procedure, the concerned company shall notify the BFAD of the final disposition of the product.
Please see attachment for flowchart of product recall procedure. The recall mechanism has worked well on several occasions when suspected intentional contamination of foods occurred in the Philippines.
The response mechanism to intentional contamination of food exists and is working well in the Philippines; however, there is a need to develop preventive measures to intentional contamination since no such mechanism exists.