CONFIDENTIAL

Lavonne KuceraCorporate DirectorQuality Assurance

Product Recalls: A- Z

Recalls A-Z

Raw Alfalfa Sprouts Linked to Salmonella ContaminationSat, 25 Apr 2009 23:00:00 -0500

The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) today recommended that consumers not eat raw alfalfa sprouts, including sprout blends containing alfalfa sprouts, until further notice because the product has been linked to Salmonella serotype Saintpaul contamination

Recalls A-Z

FDA Alerts Consumers to Recall of Certain PistachiosSun, 29 Mar 2009 23:00:00 -0500

The FDA and the California Department of Public Health (CDPH) are investigating Salmonella contamination in pistachio products sold by Setton Pistachio of Terra Bella Inc, Calif.

Recalls A-Z

• March 16, 2009 - Texas Star Nut & Food Company Announces Voluntary Recall of Raw Peanuts Due to Potential Health Risk

• March 16, 2009 - Grower's Outlet Recalls Honey Roasted Peanuts Because of Possible Health Risk

• March 16, 2009 - Ultimate Nut and Candy Co. Recalls, Sugar Free & Low Carb Peanut Butter Cups, Peanut Butter Crisp (a chocolate bark), and Peanut Butter Jars Because Of Possible Health Risks

• March 14, 2009 - Jay Robb Enterprises Inc. Voluntarily Recalls Peanut Butter JayBars

• March 13, 2009 - Kerry, Inc. Expands Voluntary Recall of Peanut Products Following Expanded FDA Investigation of Peanut Corporation of America

• March 13, 2009 - Weaver Popcorn Company Issues a Nationwide Precautionary Voluntary Recall of 12 oz. (340g) Trail's End® Chocolatey Peanut Clusters

• March 13, 2009 - Asia Cash and Carry Recalls Crown Farms Brand "Gulsha" Fish Because of Possible Health Risk

Recalls A-Z

Statistics:• 73 million people a year become ill from food• 350,000 are hospitalized• 5,000 deaths• Less than 10% of food borne illness is reported

Recalls A-Z • When is a Recall required?

– When a product is misbranded or misrepresented

• Health definitions such as “light” or “lite”, “low fat”, etc

• Weights are not as declared

– When a product is adulterated:

• Foreign material

• Chemical contamination

• Microbiological contamination

• Package labeling does not follow Food Code

• Ingredients decks are incorrect

• Undeclared allergens

Recalls A-Z

Allergens:

LeClerc Foods Announces a Limited Nationwide Voluntary Recall of Market Pantry Chocolate Chip Chewy Granola Bars due to Unlabeled Peanut Unlabeled Peanut AllergenAllergenMon, 04 May 2009 23:00:00 -0500

LeClerc Foods Announces a Limited Nationwide Voluntary Recall of Market Pantry Chocolate Chip Chewy Granola Bars due to Unlabeled Peanut Allergen

Food Allergens

What is a food allergy?• A food allergy is an immune system response to a food that

the body mistakenly believes is harmful.

What is a food allergen?• A food allergen is a food product that triggers an allergic

response in the body.

Food Allergens

The “Big 8”– Eight most common allergenic foods– Account for 90 percent of food allergic reactions– Include:

• Milk

• Eggs

• Peanuts

• Tree nuts (almonds, walnuts, pecans)

• Wheat

• Soybeans

• Fish (bass, flounder, cod)

• Crustacean shellfish (crab, lobster, shrimp)

Food Allergens

Statistics:

• In the U.S., more than 4 million people have food allergies

• Each year, food allergies are believed to cause:– 30,000 emergency room visits

– 2,000 hospitalizations

– 150 deaths

Recalls A-Z

• FDA – over 600 recalls to date in 2009

– Approximately 4 recalls every day

• USDA – 33 recalls to date in 2009

– 12 closed with over #100,000 product identified

– 21 cases remain active

Recalls A-Z

• Who Requests a Recall?• What is it the difference between a Recall and a Voluntary

Recall?• Who is responsible for carrying out a Food Recall?• What is the difference between a

– Recall

– Market Withdrawal

– Stock or Inventory Recovery

• Public Notice – who puts them out• How to close a Recall?

Recalls A-Z

Initiating a recall…..

Recalls A-Z

• Regulated product – USDA: meat, poultry and eggs– FDA: all other food including seafood, water, and non-food related

• Protect the consumer – Remove items that may cause temporary or irreversible health

consequences

• Protect the Brand– Suppliers– Manufacture

Recalls A-Z

1st celebrity falls victim to Swine Flu….

Recalls A-Z

Recalls A-Z

Recalls begin in one of two ways:

• Company discovers a problem with product– Company production records, routine testing, etc.

– Customer Complaint process

• Regulatory Agency (FDA, USDA)– Routine destination or origin testing

– Conducted by Federal Agency, military, State or local health departments

Terminology

Recall/Voluntary Recall

Removal of product that has left the firm’s control, distributed in interstate commerce and there is reason to believe the product is adulterated or misbranded within the meaning of the Federal Food Code.

• Recall does not include a market withdrawal or stock recovery

Terminology

Market Withdrawal Firm’s voluntary removal of distributed product that exhibits a minor company quality issue or regulatory program infraction that would not cause the product to be adulterated or misbranded.

• Defect would not be subject to FDA regulatory action

• i.e.: product does not meet company quality standards due to discoloration

Terminology

Stock or Inventory Recovery Removal or correction of product that has not been marketed or has left the direct control of the firm

• Product has not been marketed, or sold to a secondary party

• Must be located on the premises owned by the producing firm or under it’s control

• All product can be accounted for and has not been released for sale or use

Classifications

FDA/USDA (FSIS) Classifications:– Class I : Reasonable probability that use or exposure would

cause serious adverse health consequences or death• i.e.: product contaminated with glass

– Class II: Use may cause temporary or medically reversible adverse health consequences

• i.e.: presence of undeclared allergens

– Class III: Use is not likely to cause adverse health consequences

• i.e.: presence of an undeclared, generally recognized as safe substance

• i.e.: product not meeting specification, such as weight

Depth of Recall

• Wholesale level– Product has been distributed to a warehouse of distribution

center and it is not under the control of the manufacture

• Retail Level– Product is at retailers, but has not been sold to consumers

• HRI Level– Product is at hotels, restaurants or other institutional

customers

• Consumer Level– Product has been sold to consumers, some product may

remain under control of the retailer.

Recalls

Who Requests a Recall?– Regulatory Agency (FDA, USDA)– Military, local and State Health Departments

via Regulatory Agency– Supplier of ingredients– Manufacturer of finished goods

Recalls

• What is the difference between a Recall and a Voluntary Recall?– Recall: initiated by regulatory agency when the manufacturer

does not initiate the removal of adulterated product.• FDA has the power to institute a seizure of food via court

order that it believes is adulterated or misbranded• USDA inspectors can withdraw from inspected facilities,

effectively banning product from interstate commerce• Order manufacturing to stop until compliance with Code of

Federal Regulations is met• Detention and seizure of product in commerce• Initiates a recall letter and media notification

– Voluntary Recall: initiated by the manufacturer

Recalls

• Who is responsible for carrying out a Food Recall?– Manufacturer of the adulterated finished product

– Supplier of ingredients

– Distributor

– Warehouses

– Retail Stores

– Regulatory Agencies (Federal, State, Health, etc.)

– Media

– Consumers

Recalls

Focus on Manufacture’s or Suppliers Responsibilities..

Manufacture Responsibilities

• Key Recall Steps:

– Determine the extent of the affect product by lot, quantity, customers, states, etc. via production and distribution records

– Initiate the voluntary recall with the Federal Agency

– Notify consumer, further processing agents, distributors, warehouses

– Track action of all that handle product

– Assure proper destruction of affected product

Manufacture Responsibilities• Key Recall Steps continued:

– Conduct Effectiveness Checks

– Handle Media inquiries

– Handle consumer concerns and questions

– Conduct daily update meetings with Recall team

– Determine root cause and implement corrective action

– Clear production to produce safe, wholesome product to fill pipeline

– Maintain accurate records of actions taken and request closure of recall

Manufacture Recall Responsibilities

In Depth Look:– Determine the extent of the affect product by lot, quantity,

customers, states, etc. via production and distribution records

– Determine root cause and implement corrective action

– Clear production to produce safe, wholesome product to fill pipeline

– Maintain accurate records of actions taken and request closure of recall

Manufacture Responsibilities • Validation of product name and loting to production records

• Lot tracking of inbound ingredients– Quantities received vs. shipped from manufacture– Dates received with quantities

• Production Records– Date(s) when ingredient utilized – Names of finished product(s) that are affected – How much was produced – What are the affected lots– Product remaining in inventory or warehouse– Quantity in process (WIP), R&D, etc – Rework– Waste calculations– Quantity in carry over– Other items that were run same day or same equipment – clean to

clean

Manufacture Responsibilities• Shipment records

– Dates finished goods received into inventory

– Inventory reconciliation records

– Quantities shipped vs inventory in freezer/refrigerated warehouse, distribution centers

– Damaged goods, samples, employee purchased, etc

– PO or Customer shipment lists

– Items in transit

• Quarantine inventory at facilities, warehouses, distribution centers – Remove and physically HOLD

– Deplete any electronic inventory system

Manufacture Responsibilities• Determine root cause of adulterated or misbranded product

– HACCP Review– Validate and implement corrective action

• Swabbing records, additional swabs to find source• Engineering for PM, equipment disassembly/reassembly• Sanitation for records, personnel and on demand cleaning• Floor personnel for common links

– Resources• Food Safety extension• Regulatory Agents

• Clear production to manufacture– COA’s on in-bound ingredients– Elevated Environmental Swabbing– HOLD & test – Finished goods testing

Manufacture Responsibilities

• Maintain accurate records of action– Potential causes

– Actions taken

– Conclusions

• Work with regulatory agency on daily basis– In plant program and record review

– Facility swabbing and monitoring

• Establish Recall communications…

Communications

• Distribution channels– Warehouses– On-line customers– Retail stores

• Public Notice – Voluntary Recall: Initiating firm issues the press release with approval of

USDA/FDA– All Class I recalls must have a press release– Regulatory agency sends to Associated Press– Recalling firm can send directly to affected states for inclusion – Posted on FDA’s website: www.fda.gov– FDA weekly publication entitled “Enforcement Reports”– USDA (FSIS) posts on Recall Notification report

Communications

• Clear and concise is key– Why the product is being recalled (may be contaminated with...)– Brand Names product can be recognized as– Name of the product as found on package– Name of company recalling product– Loting of the product being recalled (use by, sell by, etc)– Risks involved in consuming products;

• symptoms and people that are at risk– Directions on what to do with product

• Return to store• Hold for pick up for central destruction

– Certificate of Destruction at landfill, notify Regulatory Agency• Properly destroy adulterated product

– Deface package and destroy contents– Consumer contact information– Media contact information, name and number

Nestlé USA’s Baking Division Initiates Voluntary Recall 

Contact:Laurie MacDonald(818) 549-6235Roz O’Hearn(440) 264-5170

 FOR IMMEDIATE RELEASE -- Solon, OH - June 19, 2009 - Nestlé USA’s Baking Division is initiating a voluntary recall of Nestlé® TOLL HOUSE® refrigerated cookie dough products. Nestlé is taking this action out of an abundance of caution after being notified that the Food and Drug Administration, together with the Centers for Disease Control, are conducting an investigation into reported E. coli 0157:H7 illnesses that may be related to consumption of raw cookie dough.

A number of consumers reporting illness reported consuming raw Nestlé TOLL HOUSE refrigerated cookie dough. While the E. coli strain implicated in this investigation has not been detected in our product, the health and safety of our consumers is paramount so we are initiating this voluntary recall. We have been and will continue to cooperate fully with the Food and Drug Administration and the Centers for Disease Control in this investigation. Providing safe, high quality products to our consumers is our number one priority.

No other Nestlé TOLL HOUSE products are impacted, including already baked TOLL HOUSE cookies purchased outside the home, all varieties of Nestlé TOLL HOUSE morsels, chocolate baking bars, or cocoa, and Dreyer’s and Edy’s ice cream products with Nestlé TOLL HOUSE cookie dough ingredients.

We want to strongly advise consumers that raw cookie dough should not be eaten. This message also appears prominently on our packaging. Nestlé TOLL HOUSE cookies made from refrigerated dough are safe to consume when baked as directed on the package. Consumers who have purchased these products should not consume them. Instead, we are asking that consumers return these products to their local grocer for a full refund. We invite consumers with questions to contact Nestlé Consumer Services at 1-800-559-5025 and visit our web site at www.verybestbaking.com.

The products involved in the voluntary recall include all varieties of Nestlé TOLL HOUSE refrigerated Cookie Bar Dough, Cookie Dough Tub; Cookie Dough Tube; Limited Edition Cookie Dough items; Seasonal Cookie Dough and Ultimates Cookie Bar Dough. Variety information is included in the list below. 

DescriptionNestle Toll House Cookie & Brownie DoughConsumerUnit Code (UPC)  COOKIE & BROWNIE DOUGH BAR Chocolate Chip bar 16.5oz0 50000 62231 3Chocolate Chip bar 16.5oz 0 50000 11308 ………

Closing a Recall

• Effectiveness Checks– Recalling firms means of evaluating how effective the recall process

was in notifying direct customers of the recall and assuring it was read, understood and followed.

• Verifies recall reached the appropriate level in the distribution chain

• If not effective, a second communication notice should be sent

• Effectiveness checks are:– Conducted by the initiating firm – Validated by Regulatory Agency

• Methods– Consignee lists– Set of questions to verify notice was received and followed– Can be conducted via mail, telephone, personal visit or via returned

electronic methods such as e-mail or fax

Closing Recalls• Initiating firm requests close from governing agency

• Written closure to include: – Name of firm requesting closure– Information regarding recalled product (name, package info, etc.)– Why product was originally recalled– Amount of product recovered– Where product was recovered from by type of business;

• Warehouse• Distributors• Stores• Consumers

– How product was destroyed, include letter of destruction if necessary– Action taken to assure process deviation that caused recall has been

corrected– Method and percent effectiveness checks– When firm believes all product was out of the market– Any reports of customer illness

Closing Recall

• Governing agency;– Conduct Effectiveness checks

– Visit processing site to assure corrections have occurred

– Issue closure if recall actions taken have been satisfactory

Recall Learning’s

• Communication is critical – Receiver needs to understand action required – Distributors through retail stores must have solid

practices in place so product does not end up back in out-bound inventory

• Retail and Consumers do not always heed…– Communication for following required steps

• Stores may be busy• Personnel understanding of need to act

– Loting information with size and manufacture codes• Complicated – pull it all

Recall Learning’s

• Understand the risk associated with ingredients

• Manage suppliers to control potential risks “you are only as good as your suppliers”

• Watch carry over and rework process…

Recall Learning’s

• Third party audits do serve a purpose, but understand they are usually announced, paid for, snap shot in time inspections. Read the fine print!

• Distribution chain has emergency information for key contacts

Recalls A-Z

• Recalls are Common– In 2009, approx 4 per day

• Have a solid recall program in place, people understand their roles and practice for preparedness– Practice, practice, practice

– Emergency contacts

– Model letters and notices prepared in advance

Recalls A-Z

Work together to remove adulterated product

CONFIDENTIAL

Lavonne Kucera Product Recalls: A-Z

THANK YOU!