Product Recall & Withdrawal Policy. For Suppliers of United Natural Foods, Inc.

Transcription

1 Product Recall & Withdrawal Policy For Suppliers of United Natural Foods, Inc. June 2018

2 TABLE OF CONTENTS STATEMENT OF POLICY.3 PURPOSE..3 DEFINITIONS....3 SUPPLIER COMMUNICATION EXPECTATIONS....5 FEES ASSOCIATED...6 UNFI RECALL & WITHDRAWAL CONTACT NAMES AND NUMBERS...7 RECALL & WITHDRAWAL INFORMATION FLOWCHART 8 UNFI RECALL & WITHDRAWAL POLICY FOR SUPPLIERS Page 2

3 STATEMENT OF POLICY United Natural Foods, Inc. (UNFI) is committed to the distribution of safe, wholesome, high quality products that meet the highest safety, regulatory, and quality standards. While dedication to product excellence is our mission, situations may arise requiring our immediate action in order to contain the problem to avoid potentially harmful products from entering the consumer pipeline. To prepare for these incidents and provide guidance when actions are necessary, it is prudent to have guidelines in place in the form of a Product Recall & Withdrawal Policy for Suppliers. The Product Recall & Withdrawal Policy for Suppliers includes communication expectations for suppliers during a recall or withdrawal. It is imperative that all potential participants in a contingency situation become familiar with their responsibilities. The Product Recall & Withdrawal Policy for Suppliers is also an important piece of UNFI s internal recall plan to ensure that the urgency and level of details of information flow is fully understood by suppliers. The adequate and timely flow of information from suppliers to the appropriate staff at UNFI will help to ensure the effective execution of a product recall or withdrawal. PURPOSE Food recalls and withdrawals occur virtually every day and are instituted for a variety of reasons. The purpose of a Product Recall & Withdrawal Policy for Suppliers is to provide a source of information outlining communication expectations and a list of contacts for suppliers to use in case of a recall or withdrawal. Timely and effective communication will guide the decision-making processes so that the necessary actions are taken with the urgency required to protect consumers. In some cases, distributed products may be in violation of government regulations. Prompt identification, location, and retrieval of the volatile products may avoid enforcement actions by regulatory agencies and media attention. DEFINITIONS (Reference: 21CFR Part 7 Subpart C through 7.59) Recall means a firm s removal or correction of a marketed product that the Food and Drug Administration (FDA) to be in violation of the laws it administers and against which the agency would initiate legal action e.g., seizure. Recalls do not include a market withdrawal, DC withdrawal, or a stock recovery. Under a recall, the product presents a threat or potential threat to consumer health or safety, involves adulteration or is materially misleading. Recall classification means the numerical designation i.e., I, II, III, as assigned by the FDA (not the recalling firm) to a particular product recall. It indicates the relative degree of health hazard presented by the product being recalled. UNFI RECALL & WITHDRAWAL POLICY FOR SUPPLIERS Page 3

4 Effectiveness checks are used to verify that all consignees at the recall depth specified by the strategy have been notified about the recall and have taken appropriate action. Class I Recall is a situation in which there is a reasonable probability that the use of, or exposure to, a volatile product will cause serious adverse health consequences or death. Effectiveness checks are normally Level A and would be expected to account for 100% of the consignees that could reasonably be expected to be recovered. Examples: C. botulinum; Listeria monocytogenes; E. coli; cyanide; glass, or metal fragments of sufficient size to cause harm to consumer; presence of undeclared allergens including peanuts, some tree nuts, and eggs. Class II Recall is a situation in which the use of, or exposure to, a volatile product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. Product is at the retail level. Effectiveness checks normally must account for 90-99% of the product that could reasonably be expected to be recovered. Examples: Undeclared FD&C Yellow No. 5 and FD&C Yellow #6; undeclared allergens such as dairy, soy, and wheat. Class III Recall is a situation in which the use of, or exposure to, a volatile product is not likely to cause adverse health consequences. Effectiveness checks account for 75-99% of the product that could reasonably be expected to be recovered. Examples: Gross underweights, misbranding, or lesser quality problem not representing significant peril to the consumer. Market Withdrawal means a firm s removal or correction of a distributed product which involves a minor violation that would not be subject to legal action by the DFA or which involves no violation e.g., normal stock rotation practices, routine equipment adjustments and repairs, etc. The key distinction from a recall is that the suspect product is not volatile or it involves only minor violations that are not sufficient to subject the product to legal action under existing compliance policy. Product has penetrated distribution channels at warehouses, major wholesalers, and direct accounts. Effectiveness checks include 75-99% of the product that could reasonably be expected to be recovered. Examples: Underweights, flavor/odor deviations; or minor quality problems. Stock Recovery means a firm s removal or correction of a product that has not been marketed or that has not left the direct control of the firm. A stock recovery may be used regardless of the magnitude of the deviation, provided that no product has been released for commercial distribution to trade. For example, the product is located on premises owned by, or under the control of, the firm and no portion of the lot has been released for sale or use. Consignee means anyone who received, purchased, or used the product being recalled or withdrawn. Correction means repair, modification, adjustment, relabeling, destruction, or inspection of a product without its physical removal to some other location. UNFI RECALL & WITHDRAWAL POLICY FOR SUPPLIERS Page 4

5 Recall Strategy means a planned specific course of action to be taken in conducting a specific recall, which addresses the depth of recall, need for public warnings, and extent of the effectiveness checks for the recall. Health Hazard Evaluation* means an examination of the health hazard presented by a product being recalled or considered for recall. An evaluation will include but not be limited to the following factors: Any disease or injuries that may have already occurred from the use of the product Any existing conditions that could contribute to a clinical situation that could expose humans or animals to a health hazard Assessment of degree of seriousness of health hazard to which the population at risk would be exposed Assessment of the likelihood of occurrence of the hazards Assessment of the consequences (immediate or long term) of occurrence of the hazard *The official health hazard evaluation is conducted by an ad hoc committee of FDA scientists. They review known information about the hazard, compare that to information submitted, and assign the Recall Category. SUPPLIER COMMUNICATION EXPECTATIONS Supplier must provide their most current recalls and withdrawals contact information to their UNFI representative. Furthermore, suppliers must immediately notify their UNFI representative and all of the National Recall Team members of each and every recall and withdrawal and must provide all of the pertinent information regarding the recall or withdrawal. Suppliers must supply factual information in writing via (first) and may supplement with a phone call and must include the following on a dated official company letterhead: Product description with all relevant information: o Lot or series number o PO number o Production date o Sell date o How was product found? Date and quantity shipped When and where product was grown or manufactured Recall classification (if assigned) What hazard, health, or otherwise, does the product pose to the public? UNFI RECALL & WITHDRAWAL POLICY FOR SUPPLIERS Page 5

6 If a health hazard: o Has anyone been hospitalized? o Has anyone died? o What pathogen is involved? o Were there any injuries that did not require hospitalization? o What was the nature of the contamination-tampering? Has the supplier contacted the appropriate regulatory agency? What steps has/will the supplier take to communicate the recall to the media? Supplier should continue to contact UNFI until which time that they receive written confirmation that the recall and withdrawal information has been confirmed, received, and adequate. Suppliers should immediately update UNFI of any change in recall and withdrawal status and to the same people, by phone and written via , with the same detailed information as stated above. Suppliers may not send recall or withdrawal notifications via paper mail. Penalties will apply. FEES ASSOCIATED Category or Class Quantity of Customers Potentially Receiving Affected Product Charge per Distribution Center Affected DC Withdrawal N/A N/A $500 Market Withdrawal $1000 $2000 $500 Recall (Class I-III) $2000 $4000 $500 Expansion of Recall Original fee + ½ of the original fee Original fee + ½ of the original fee Original fee + ½ of the original fee ($500 for every new DC affected) Disposal Fees See UNFI Disposal Fees* Supplier must provide disposition within 48 hours of Recall or Withdrawal notice; otherwise, UNFI will determine the disposition e.g., destruction, return to vendor (RTV), donate, etc. Cost of doing business incurred by UNFI may be transferred to Supplier i.e., customer recall/market withdrawal penalties. Supplier must notify UNFI prior to customers or are otherwise subject to a $1000 fee. A Recall or Market Withdrawal notification that reaches UNFI >24 hours is subject to a $1000 fee. Special circumstances may apply. UNFI RECALL & WITHDRAWAL POLICY FOR SUPPLIERS Page 6

7 UNFI DISPOSAL FEES A minimum charge of $ will be applied to any product that is disposed of by UNFI weighing less than one ton per each DC plus the below charges: $50.00 admin fee $35.00 per hour per each UNFI employee to dispose of product, minimum one hour Any product weighing one ton will have the minimum charge of $ applied plus the below charges: $50.00 admin fee $ charge for dumpster pick up $70.00 per added ton $35.00 per hour per each UNFI employee to dispose of product, minimum one hour UNFI NOTICE OF DISPOSAL 1. UNFI reserves the right to deny disposal of any products in any amount that may have a potential risk to leak out of our dumpsters e.g., liquid, dry, or chemical. 2. In the event that UNFI cannot dispose of a product and notice has been given to a vendor, a storage charge of $25.00 per day will be applied to a credit for product that has not been picked up after 14 business days. UNFI RECALL & WITHDRAWAL CONTACT NAMES AND NUMBERS For all recalls and withdrawals, contact recalls@unfi.com. RECALL & WITHDRAWAL TEAM MEMBERS Recall InfoLink Customer Support: customersupport@recallinfolink.com UNFI Recall recalls@unfi.com National Director of Food Safety & Quality recalls@unfi.com National Food Recall Specialist recalls@unfi.com UNFI RECALL & WITHDRAWAL POLICY FOR SUPPLIERS Page 7

8 RECALL & WITHDRAWAL INFORMATION FLOWCHART Recall/Withdrawal Notification Received Recall Specialist (RS) Notified by Supplier of Recall/Withdrawal Recall Team receives notification and disseminates to staff within 4 hours (recalls)/24 hours (withdrawals) Inventory Control (IC) Recall Specialist (RS) Purchasing received by all Site IC Managers and Ops Managers from the RS Site places ALL affected product on hold and has all product isolated and tagged on hold IC Manager reports ALL Information RS IC completes disposition of product and reports completion to the RS Sends to Customer Service, Sales, Legal and Purchasing Runs National Recall Report based on parameters from Supplier to determine all affected Customers Initiates contact with customers via Recall InfoLink Sends list of unreached customers to Customer Service for contact by reps. Customer service manager notifies RS when all contacts have been made Contacts Supplier to elicit any and all information not received in the initial notification and forwards to RS Works with RS to recover all expenses associated with the recall In conjunction with the Recall Team, reviews the final recall documentation to determine future viability of Supplier/product line RS consolidates all information and completes Final Recall Report and maintains for 2 years UNFI RECALL & WITHDRAWAL POLICY FOR SUPPLIERS Page 8