APPENDIX I: OUTLINE OF PROCEDURE FOR A PRODUCT RECALL

1. Summary - Product Recall

Potential product recalls should be quickly reported and investigated by a responsible decision-maker who has the authority to assign the recall classification to the situation. When warranted, a Recall Committee should be appointed.

The Recall Committee and its chairman should be quickly convened when a Class I, II, or III situation exists.

All information received and communication released regarding the recall should be approved by the chairman of the Recall Committee.

Complete records and samples should be kept in the control of the production manager. Communication is so critical in a recall situation that the members of the Recall Committee may need to devote nearly full time to the emergency in its earliest stages. A telephone hotline may need to be installed for customer and other inquiries.

The recall policy and procedures should be reviewed each year.

2. Definitions

The following are possible government definitions for the product recall procedure.

Class I Recall - A serious emergency recall situation involving product which may have an immediate or long range effect on the life or health of aquatic animals or human consumers.

Class II Recall - A priority situation involving product which may be a potential hazard to human or animal life or health.

Class III Recall - A situation involving product which does not pose a health threat, but which may have serious or wide-spread customer or public relations implications.

External Recall - The removal of product from the market in which distribution has been made beyond the direct control of the feed miller’s organisation.

Internal Recall - The removal of product from the market, none of which has left the direct control of the manufacturer.

Retention - Holding product from the market or from further processing or shipment when there is evidence of a quality or labelling deviation in the formula for the target species.

3. Procedures

When the potential for a recall becomes evident, the production manager and quality control manager should be informed immediately.

The quality assurance manager may assume the responsibility to immediately investigate, using any resource within the company, to determine whether the situation is a Class I, II, or III recall or is of lesser priority. The quality assurance manger needs to make the classification decision as quickly as possible.

If the decision is that it is a Class I, II, or III recall, the quality control manager should immediately convene the Recall Committee. The chairman should then co-ordinate all recall activities, keeping the committee members informed. A lesser priority situation may be handled at the plant level without a committee being convened.

The Recall Committee should include persons with expertise in these areas:

• Regulatory
• Production
• Sales
• Quality Control
• Public Relations
• Legal
• Purchasing
• Nutrition

The Recall Committee should decide the quickest and best overall procedure for handling the recall. Since each situation will be unique, the following are guidelines which may be useful:

• Determine the suspected product’s identification codes and the dates of its manufacture.
• Determine where the entire product is now located. In other words what is the status of the aquaculture feed in question?
• Immediately notify all locations where the product was shipped. Mandate a “stop sale.” If the product has been sold to consumers, contact the sellers (distribution) and ask them to make a listing of all consumers who received the product.
• Get the Recall Committee input as to how to handle all contacts outside the company, such as consumers, agents, dealers, media, etc.
• Decide whether the media need to be notified. If so, let the public relations department or its designee handle it.
• Decide whether government agencies should be immediately notified. They may be of help, but may also make matters worse if the officials believe a concealment has been attempted.
• Someone should be assigned to make and retain accurate records of what was produced, shipped and later accounted for, and finally disposed. Also a record of recall actions and their date and time may be needed for legal protection.
• Be sure any samples secured are properly identified and safeguarded; refrigerate if appropriate to prevent degradation. If sample analysis is required, have it done on an expedited basis while always retaining duplicate lots of each sample lot submitted.
• Communicate. Keep the Recall Committee, the plant manager, any customers, and the news media (if necessary) informed, so that inaccurate information cannot accidentally replace facts or is misconstrued.
• A 24-hour hotline phone number may need to be implemented, to answer any questions from consumers.

4. Recall Committee	Name	Home Phone
Chairman:	___________________________	___________________________
Public Relations:	___________________________	___________________________
Production:	___________________________	___________________________
Sales (Retail):	___________________________	___________________________
Quality Control:	___________________________	___________________________
Purchasing:	___________________________	___________________________
Legal:	___________________________	___________________________
Regulatory:	___________________________	___________________________
Nutrition:	___________________________	___________________________
Additional Contacts in a Product Recall
Insurance Carrier: ______________________ phone #
Hotline:	Government Agriculture Department

Government agencies should only be contacted by the Chairman of the Recall Committee. When reporting a recall to a government agency, be sure to record the date and time of the call and the name of the government employee taking the call.

5. Optional Recall Check List

		Yes	No	Comment
1. Has the Recall Committee been activated?		___	__________	______________
2. Has the suspect product been identified?		___	__________	______________
3. Has the identification code and date been determined?		___	__________	______________
4. Has it been determined where all the product is located at present?		___	__________	______________
5. Have all affected locations been notified?		___	__________	______________
6. Has product been shipped to consumers? If so, has a consumer list been established?		___	__________	______________
7. Have consumers been notified?		___	__________	______________
8. If appropriate, have the media been contacted?		___	__________	______________
9. Has a government agency been notified? If no, why?		___	__________	______________
10. Have the following documents been secured?
	Batching records surrounding product	___	__________	______________
	Shipping records	___	__________	______________
	Ingredients records	___	__________	______________
	Bulk records	___	__________	______________
	Bagging records	___	__________	______________
	Labelling records	___	__________	______________
	Minutes of Recall Committee	___	__________	______________
11. Have samples been received and properly identified and preserved?		___	__________	______________
12. Are samples safeguarded?		___	__________	______________
13. Have samples been analysed for the suspected source and/or cause of incident?		___	__________	______________

In notifying a customer, consumer or a dealer/distributor remember to:

• Alert, but do not alarm
• Be frank and honest
• Advise of lot (ID) numbers in question
• Have a workable feed replacement program
• Be prepared to answer questions or complaints
• Document in detail all conversations