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

Prevention and Response to Intentional Contamination

(Prepared by the Philippines)

Introduction

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.

Response to Intentional Contamination

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:

1. Class I recall- is a situation in which there is a reasonable probability that the use or exposure to a violative product will cause serious adverse health consequences or death.
2. Class II recall - is a situation in which use or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
3. Class III recall - is a situation in which the use or exposure to a violative product is not likely to cause adverse health consequences.

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:

1. identify of the product involved
2. reason for the removal or correction and the date and circumstances under which the product deficiency or possible deficiency was discovered
3. evaluation of the risk associated with the deficiency or possible deficiency
4. total amount of such products produced and/or the time span of the production
5. total amount of such products estimated to be in distribution channels
6. distribution information, including the number of distribution outlets and where necessary, the names and addresses of the distribution outlets
7. a copy of the firm's recall communication if any has been issued or a proposed communication if none has been issued yet
8. proposed strategy for conducting the recall
9. name and telephone number of the official who should be contacted concerning the 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:

1. whether a disease or injury has already occurred from the use of the violative product
2. whether any existing condition(s) could contribute to a clinical situation that could expose humans or animals to a health hazard on the basis of scientific evidence
3. assessment of the hazard to various segments of the population e.g. pregnant women, children, pets, livestock etc. who are expected to be exposed to the product being considered
4. assessment of the degree of seriousness of the health hazard to which the population at risk would be exposed
5. assessment of the likelihood of occurrence of the hazard
6. assessment of the consequences (immediate or long-term) as a result of the occurrence of the hazard

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:

1. the firm's violation
2. the health hazard classification
3. the recommended recall strategy to be undertaken by the firm
4. Other instructions appropriate to the conduct of the recall.

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:

1. Depth of recall - depending on the product's degree of hazard and extent of distribution, the recall strategy will specify the level in the distribution chain which the recall is to extend (i.e. consumer level, retail level or wholesale level)
2. Public health alert warning to be used by the recalling firm - the purpose is to alert the public that a product being recalled presents a serious hazard to health
3. Effectiveness checks - the purpose is to verify that all consignees at the recall depth specified by the strategy have received notification about the recall and have taken appropriate action.

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:

1. Class I recall - seven (7) days
2. Class II recall - fifteen (15) days
3. Class III recall - thirty (30) days

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:

1. Number of consignees notified of the recall, and date and method of notification
2. number of consignees responding to the recall communication and quantity of products on hand at the time it was received
3. Number of consignees that did not respond (if needed, the identity of non-responding consignees may be requested by the BFAD)
4. Number of products returned or corrected by each consignee contacted and the quantity of products accounted for
5. Number and results of effectiveness checks that were made
6. Estimated time for completion of recall

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.

1. If the product is to be destroyed, the destruction should be witnessed by a BFAD representative
2. If the product has been reprocessed to comply with registered specifications, distribution and sale of the reprocessed product shall only be allowed following a written recommendation from the BFAD to do so.

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.

Conclusions

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.

FLOWCHART: PRODUCT RECALL