Product Recall Template for

Manufactured Feeds

Prepared by the New Zealand Feed Manufacturers Association (Inc.)

Version 1

October 18, 2011

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Overview

This section serves as an introduction to product recalling and outlines the responsibilities of a feed manufacturer in the event of a product recall.

What is a Product recall?

Product producers use many controls to ensure the safety of their products being manufactured. Despite their best efforts, however, sometimes unsafe products, defective, or those that do not meet legislative requirements, make their way into the marketplace. When a potentially unsafe or defective product has left control of the manufacturer, it must be removed from the market. This process of removing the product is called a recall.

What is a Feed Manufacturers Roles/Responsibilities in a Product recall?

Manufacturers have the following responsibilities:

Remove the unsafe product from sale Maintain records and establish procedures that will facilitate a recall Have a written recall plan Initiate the action for implementing a recall In the case of a consumer level recall, notify the public For imported product, contact overseas supplier/manufacturer when initiating the

recall action

The manufacturer should seek to comply with the recall system to effectively and efficiently remove the product from the market place in a timely fashion.

What is a voluntary product recall?

This occurs when a product manufacturer voluntarily takes action to remove it from distribution, sale, and/or consumption. The word ‘voluntary’ does not correspond to whether or not the distribution network/chains can choose to remove the product from sale. When a recall occurs, all of the product subject to the recall must be removed from the market place. MAF must be informed.

What is a mandatory product recall?

This occurs when the MAF orders a product to be recalled from distribution, sale, and/or consumption. Mandatory recalls will occur only when the manufacturer will not voluntarily recall its product and the food product is a risk to public health and safety.

What is a product withdrawal?

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This occurs when a product is removed from the supply chain where there is no public health or safety issue. Withdrawals do not require notification to MAF or consumers. If a withdrawal is converted into a recall, then notification to MAF and consumers is required.

A product withdrawal may occur because:

The product has a quality defect (e.g. color, texture, etc.) or is underweight or has labeling irregularities that do not pose a substantial risk to public health and safety.

As a precaution, pending further investigation of a potential public health and safety risk. If a risk to public health and safety is established, then the product must be recalled.

What is a Product recall program/system?

It includes the procedures and arrangements that a manufacturer has in place which enables it to retrieve products from the supply chain if a problem arises.

What is a Product recall plan?

It is the written documents a manufacturer produces to ensure the recall system it has is in place, is followed and compiled with to recall unsafe product. It should detail the procedures, arrangements, staff responsibilities and records required as part of the product recall system.

A Product recall plan should include information on the following:

1. Recall team2. Compliant file3. Recall contact list4. Traceability 5. Production records6. Shipping and sales records7. Recalled product records8. Recall procedures9. Recall effectiveness records

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Recall Product Decision Tree:

Figure 1: A general decision tree illustration the major steps of the process of recalling or withdrawing product. Please note that the purpose of this template is to cover the process of recalling a product (see the dashed-line box).

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This product recall template serves as a guide for manufacturers. It aims in assisting manufacturers in order to:

1. Stop the delivery and sale of the product in question2. Inform the appropriate regulatory agencies3. Allow for the proper and timely removal from the marketplace of the product in

question.

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Conducting a product recall

This following section explains when a recall may be required and how to determine the extent of the product recall.

When to initiate a product recall:

A manufacturer may be informed of a problem with its feed via the following mechanisms:

In-house testing indicating that there may be a potential problem with a particular product or product batch

Customer compliant/feedback informing the manufacturer of a potential problem A supplier of feed ingredients that is used by the company manufacturing products

informs them (the company) that there is a problem with a feed ingredient Government authorities indicate that there may be a problem with a particular

product.

Such problems may include:

Chemical contamination The presence of foreign matter Labeling errors Packaging defect Under-processed product Residue limits outside of acceptable limits Veterinary medicine residue issues

It is important that all necessary information about the nature of the problem is obtained so that an assessment can be made to establish whether a food product is unsafe and recall action is required. Expert advice may be needed to assess the risk.

Once a decision to recall a product has been made, then the three primary objectives of: 1) stopping the delivery and sale of the product in question; 2) informing the appropriate regulatory agencies and; 3) allowing for the proper and timely removal from the marketplace of the product in question; will need to be performed by the manufacturer of the recalled product in question.

The level of the product recall:

Depending on the extent of the distribution of the product, the recall action will be either a trade level recall or a consumer level recall. In determining the recall level, the following should be considered:

The channels by which the product has been distributed The extent of the distribution (e.g. has the product reached the end user)

Once these are determined then a product recall plan needs to be implemented. The following section will discuss the components of a product recall plan.

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Components of a product recall plan:

Recall team

A group of members within a company designated to deal with product recall issues. The recall team should include a recall coordinator who will coordinate the recall.

Being able to identify team recall members and assigning recall duties enables the recall procedures to be conducted efficiently.

The recall coordinator should have the appropriate authority to call upon other recall team members as needed to address any issues at hand.

It is also recommended that contact information should be included in a recall team list that is formulated to deal with recall issues. Including public relation personnel is highly recommended.

The recall team should include people responsible for:

Recall decision making Quality assurance/Technical advisory Media communication (may include ‘in-house’ media personnel) Complaint Investigation Contacting customers Contacting the appropriate regulatory body Possible legal counsel

Complaint file

An information file containing a particular product that requires further investigation, recall or withdrawal.

When a complaint is received, it is important to record the details and start an investigation. A complaint file should consist of the following:

Complaint information - information on the person/group lodging the complaint (name, address, contact information, any observed illness or injury).

Problem details – A description of the problem (reaction, illness, etc.). Product details – The product name, lot number or production date, package size

and type, any other possible identifying codes, a sample of the product (if possible).

Retail details – name, address of the person/business that purchased the product and the date of purchase.

How the product was stored and handled by the Complainant

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Detailed illness or injury, consumption, number ill, age of animals ill, etc. Details and records of the complaint investigation. This should include:

o An investigation of all products that may have been affected o Records containing the names of the persons involved in the investigation,

date, findings, and other product that might be affectedo Action that was taken based on findingso A record that the appropriate agencies have been included in a discussion

around the recall and confirmation that the actions the company taken are indeed satisfactory/correct.

Recall contact list

A list of persons/companies or agencies that need to be contacted in the case of a product recall. This should contain the names, address, and contact information for regulatory agencies (MAF-ACVM) and companies/distributors that receive or handle the product. All relevant parties need to be notified and are listed in attachment 1.

If any confidential commercial information is not wished to be provided, then the regulatory agency needs to be notified about this. Confidential commercial information includes:

A trade secret relating to the animal feed Any other information relating to the feed that has a commercial value that would

be, or could reasonably be expected to be, destroyed or diminished if the information were disclosed

Product distribution networks and trade customers need to be notified to prevent distribution of the product in question. This includes retailers if the product has been distributed to the retail level. Notification should be made quickly to minimize the extent of the recall product being distributed.

Public notification is also essential if the product in question has been available for sale to consumers/end-users. Consideration needs to be given to which forms of publicity are to be used and how much media contacts are to be informed.

Other organizations affected by the product recall (such as the NZFMA) should also be notified.

Traceability

The means to determine which products are in need of a recall through appropriate records throughout the manufacturing and (possibly) the distribution process. If the specific affected product cannot be identified, it may mean that the recall scope will need to be broadened.

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Production records

Records that are able to demonstrate, with accuracy, how much of each lot of product is produced. In case a recall occurs, a company must ensure that as much of the affected product is removed from the marketplace. Having sufficient production records means that a company can track affected products still on the premises or sold to customers.

Shipping and sales records

Records that can track the amount of each lot of product distributed to each customer. Sufficient shipping and sales records allow a company to limit a recall to the customers who received affected products. Shipping and sales records should include:

Customer name and contact information Product name and lot code Amount of product shipped to each customer.

Products may be recovered by returns to retailers, returns via distribution chains or direct returns from consumers.

Recalled product records

It would be beneficial to also have recall product records to ensure that recalled products were appropriately managed and controlled. Product recall records should include the name of the product that was recalled, the amount, the date the product was recalled and any possible corrective actions taken.

The recovered product may be returned to a central site or, in the case of a widely distributed food product, to major recovery sites. Some major retailers will retrieve and dispose of the stock at store level. The recovered product must be kept separate and clearly identified in some way.

Recalled product disposal should be determined by the recall team/company in conjunction with the relevant agencies. Options for disposal of the product include:

Destruction Further processing to ensure safety and suitability of the product Ascertaining that the returned food product is safe and suitable for alternative use

Recall procedures

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Every product recall plan should contain a step-by-step explanation of what to do when a product needs to be recalled.

Following this plan will assist in ensuring that important steps are not overlooked and that the product recall can be managed appropriately. Recall procedures should explain product coding, product traceability, and production and distribution records.

** note that all necessary forms to be used in case of a recall will be listed in the attachments of this product recall template (see Attachments).

The steps in any recall are similar and should:

Identify the concern Assemble the recall team Notify MAF Decide to recall/ or not Identify all products to be recalled Segregate (put on hold) affected product that are in the company’s direct control Prepare a distribution list Prepare a press release (if necessary) Notify customers (informing them what to do with the recall products) Control recalled products and decide what to do with them Dispose of the recalled products or rework product Perform any corrective actions as a result of the recall and ensure that the corrective

actions remedy the situation

Recall effectiveness records

A company recalling a product is responsible for notifying all customers who bought the affected products. They should also verify that all customers have stopped the distribution of the affected products, and that all recalled products have been returned to the distributor or the company or any other designated area instructed in in the recall notification.

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Attachment 1 – Contact details for relevant New Zealand Agency and Feed Manufacturing Association:

Ministry of Agriculture and Forestry –ACVM

Glen BradburyManager, ACVM Appraisal and Programmes

Tel:       04 894 2500      Fax:      04 463 2566Mobile: 029 894 2500

NZFMA

Michael BrooksExecutive Director, New Zealand Feed Manufacturers Association (Inc.)

Tel: 09 520 4300Mobile: 027 221 8228Email: michael@pianz.org.nz

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Attachment 2 – Written notification template for agencies/organizations:

RE: NOTIFICATION OF PRODUCT RECALL

(Insert Date)(Insert Company name, product, product size and product description)

To (Insert the relevant person in their agency/organization)

We would be grateful if you could acknowledge this (Insert either the word ‘email’ or ‘letter’) as official notification for the above product recall.

Nature of the product(Insert information that will help identify the product – for example, name of product, package size, lot identification (batch and/or code numbers), packaging date, type of product, the animal species that the product is intended for)

Nature of the problem(Describe the problem)

Action taken or proposed(Say what you have done or are going to do. For example:

We have notified all our outlets/distributors/customers We have notified the relevant organizations We are in the process of recovering the product from the above identified outlets and

consumers We are going to perform a (Insert either the word ‘customer’ or ‘trade’)-level recall We have scheduled press advertisements to appear in the (Insert all applicable

newspaper(s) or relevant press agencies) on (Insert the date corresponding to when the press advertisements will appear/be announced).

Should you require any further information please contact us on (Insert telephone number or email address).

Yours sincerely

(Insert your first name and address)

(Insert the date)

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Attachment 3 – Written notification template for distributors/customers:

Initial notification should be done initially by telephone and followed up with a written communication. Recall letters should include factual information of the reason(s) for the recall of the product, plus specific details that will allow the product to be easily identified. The text should be agreed upon by MAF-ACVM before the letter is sent.

Notification to Distributors and CustomersPLEASE CONTACT BY PHONE AND FAX ALL YOUR DISTRIBUTORS AND CUSTOMERS AND GIVE THEM THE FOLLOWING INFORMATION

Distributors name and address

PRODUCT RECALL(Insert Company name) is conducting a product recall.

The product involved is (Insert information that will help identify the product – for example, name of product, package size, lot identification (batch and/or code numbers), packaging date, type of product, the animal species that the product is intended for)

Consumers are being advised that the above product is being recalled because (Insert the reason for the recall).

As a precaution we are recalling all supplies of the product with the above identification. Consumers have been asked to return the purchased product. They will receive a refund.

If any of the recalled stock has been distributed by you to other distributers or customers then please immediately inform those distributors or customers of this recall. Then telephone our office (included below) so that we can make contact with these distributors or consumers.

Please hold the recalled product in an isolated and secure area pending further advice.

We apologize for this inconvenience.

(Insert the name of the Company, address and contact phone numbers)

(Insert the date)

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Attachment 4 – Paid advertisements and media releases:

Paid advertisements and media releases are used to notify the public of a consumer level product recall. A newspaper advertisement is the most common method used (Figure 2). If immediate dissemination is required, a media release may be utilized.

Paid advertisementsIf the recall is at the consumer level, the company may need to organize and pay for the advertisements to be placed in daily media print in the relevant region where the product was distributed to.

Sample press advertisementsA draft advertisement should be submitted to MAF-ACVM for comment prior to the advertisement being sent out for publication. Figure 2 gives such an example.

SizeIt is recommended that the minimum size for recall press advertisements is 2 columns wide and 10 centimeters in height. It should be enclosed in a diagonally hatched border, preferably with the internationally recognized safety triangle in the top left-hand corner. Note: consideration should be given to the appropriate font size (minimum of size 8) and style to be used in the advertisement to ensure the printed text is easy to read.

Position of advertisement in print mediaIt is important that recall advertisement appear at least in the first half of the chosen daily print media.

Heading of advertisementThe heading should be ‘Product Recall’.

Advertisement textThe text of the recall advertisement should provide information about each of the following:

The name of the product The package size The date packaged’ Any other details necessary for identification The reason for recall The need to identify and quarantine the product Where appropriate a description of possible symptoms and/or advice to consult a

veterinarian should be included Contact details of the company, including telephone number

Media releaseTo ensure the widest possible dissemination, and to cover both electronic and print media, companies undertaking a consumer level recall should also consider issuing a media release. This is practically pertinent if the product is of very high risk to animal health or safety. The media release should contain the same information as the paid advertisement and should be developed jointly with the company and MAF-AVCM.

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Expert advice from a veterinarian, ‘in-house’ media personnel or other specialist may be required.The company should identify a company contact person to liaise with the media. Their contact details should be included on the media release to allow access to further information.

Media releases are intended to bring the problem to the attention of consumers as quickly as possible, and are used when there may be a delay of several days in the publication of a paid advertisement in the newspaper.

Figure 2: An example of a product recall press advertisement; (1) Type of Recall (2) Name, size and description of product (3) Reason for recall (4) Hazard (5) Identity (6) Disposal (7) Company contact details

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PRODUCT RECALL

Al’s Feed MillLayer Hen Pellet Feed plus– 20 kg bags

Manufacture Date: 26/10/11

Al’s Feed Mill Ltd is conducting a voluntary consumer level recall of the above product due to veterinary medicine residue issues.

Tests have detected residues of lincomycin. Layer Hens should not consume this feed. Any farmers concerned about the health of their hens should seek

veterinary advice.The recall applies to only the above product with the nominated size and

manufacture date. No other Al’s Feed Mill products are affected by this recall. Customers are asked to return the product to the point of purchase for

immediate refund.Al’s Feed Mill is greatly concerned at any risk to hens consuming this product.

This recall is being undertaken to ensure the safety our customers hens as an on-going commitment to maintain the highest possible standards of safety and

product quality at all times.We apologise for any inconvenience.For further information please call:

09 520 4300Al’s Feed Mill Ltd.

96D Carlton Gore Rd, Newmarket, NZ, 1023

(1)

(2)

(3)

(4)

(5&6)

(7)

A basic list of some New Zealand Newspapers for press advertisements

Herald tel 09 379 5050

Dominion Post tel 04 474 0196

Northern Advocate tel 09 470 2875

Daily Post tel 07 348 6199

Waikato Times tel 07 849 6180

The Press tel 03 379 0940

Otago Daily Times tel 03 477 4760

Straight Furrow tel 09 523 5056

Also it might be advantageous to place this on the company website (if applicable) or on the NZFMA website.

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Attachment 5 – Post recall reporting:

One or two months after the implementation of the recall, the company should provide MAF recall coordinator (if known) with an interim and final report, respectively, on the recall. The reports should contain the following information:

A copy of the recall letter to customers The circumstances of the recall The action taken by the company, including any publicity, with names of newspapers

in which advertisements appeared The extent of the relevant batch of food product in New Zealand and overseas (if

applicable) The result of the recall (quantity of stock returned, corrected, outstanding, and so on) The method of disposal or otherwise of recalled stock, with certificates of destruction Action proposed for the future to prevent a reoccurrence of the problem Any difficulties experienced in conducting the recall Details of written information provided by government authorities or industry

organizations that assisted the recall

All of this above information can also be used for modifying recall procedures and practices.

The interim and final reports provide information about the effectiveness of the recall.

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Attachment 6 – Example of a Recall Distribution Register

Recall Distribution Register

The Recall Distribution Register is a log of the complete distribution of the affected product. This information on the following form is derived from dispatch records and sale invoices. For an effective recall to occur, it is important that not only quantities are recorded, but also product batch codes and dates of dispatch, etc. This system needs to be robust and the information readily available to senior management if needed.

Recall Distribution RegisterProduct name: Batch Code(s):

Product Size: Date of Manufacture:

Total Amount Produced (Kg): Additional Information:

Distribution Profile (From dispatch records)

Date Customer Name Location

Amount of

product sent to

customer

Date customer

was contacted

about recall

Amount of stock

remaining

Total Stock accounted for =

Total Stock unaccounted for (in trade/consumed) =

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