Planning & Preparedness Procedures

Food Recalls:

Planning & Preparedness Procedures

Table of Contents

1. PURPOSE

2.SCOPE

3. BACKGROUND

4. RESPONSIBILITY

5. DEFNITIONS

6. RECALL PROCEDURES

7.RELATED DOCUMENTS

8. EQUIPMENT/MATERIALS

9. SAFETY

10.CIRCULATION

11.APPROVAL/HISTORY

1. PURPOSE

The purpose of this policy is to outline and provide best practices and procedures for key areas of the recall strategy of the Georgia Department of Agriculture (GDA) as it pertains to food product recalls within the state of Georgia.

1. SCOPE

This policy applies to all GDA personnel involved in recall procedures on the state level including Georgia Food Inspectors of Manufacturing, Distributing, Wholesale and Retail food firms, including inspections conducted under contract with the Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA). This policy may also be applicable to Georgia Feed Inspectors, including inspections conducted under contract with the Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA). GDA Food Processing Specialists are required to follow this protocol unless the inspection is not covered in the policy. Applications of this protocol may also apply directly, or indirectly, to the policies associated with activities of the Georgia Food and Feed Rapid Response Team, GDA Public Affairs staff and GDA Chief Security Officer and staff.

1. BACKGROUND

A recall refers to a firm’s removal or correction of marketed food products from commerce when there is evidence of a violation, such as products that are adulterated or misbranded under the provisions of applicable state and federal laws. Manufacturers and/or distributors may voluntarily initiate a recall at any time to fulfill their responsibility to protect human and animal health from products that present a risk of injury, gross deception, or are otherwise defective. Firms may also initiate a recall following notification of a problem by GDA or FDA. Additionally, firms may initiate a recall in response to a formal or informal request by FDA, a mandatory recall statute, or an order issued by FDA.

1. RESPONSIBILITY
2. Program Managers – The Manufactured Food and Retail Food Program Managers will review and issue final approval of all food program policies and procedures.
3. Ag Inputs Manager – The Ag Inputs Manager will review all policies and procedures and issue final approval of all feed program policies and procedures. Ag Inputs Manager will also provide relevant training to RRT members and feed inspectors.
4. Rapid Response Team– Georgia RRT leadership will ensure personnel assigned to perform tasks within a recall strategy have been provided with appropriate training, in conjunction with the Regulatory, Educational and Outreach Program Coordinator.RRT members are responsible for playing an active role in maintaining both subject matter expertise and ability to work effectively in multidisciplinary and multi-agency response teams pertaining to matters of food safety and food recalls.
5. Regulatory, Educational and Outreach Program Coordinator – The Training Coordinator will ensure that all staff receives training in conjunction with carrying out the responsibilities of this SOP.
6. Food Processing Associate / Supervisor - The Food Processing Associate / Supervisor will ensure all assigned staff in their respective program area receive the appropriate training and follow the procedures described.
7. Food Safety Inspector – FSIs will follow the procedures described as applicable to their position and notify the Food Processing Associate and/or Manufactured Food Program Manager when the procedures cannot be followed.
8. Recall Outreach Specialist –The Recall Outreach Specialist will follow the procedures described as applicable to their position, focusing on recall audit checks to review effectiveness, and will serve as a liaison to the public affairs office in drafting press releases and consumer notifications.
9. DEFINITIONS
10. Recall: A firm's removal or correction of a marketed product that GDA, FDA or USDA consider to be in violation of the laws it administers and against which the FDA would initiate legal action, e.g., seizure. Recall does not include a market withdrawal or a stock recovery.
11. Market Withdrawal: A firm's removal or correction of a distributed product which involves a minor violation that would not be subject to legal action or which involves no violation, e.g., normal stock rotation practices, routine equipment adjustments and repairs, etc.
12. Stock Recovery: 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, i.e., 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.
13. Recall Classifications: The numerical designation, i.e., I, II, or III, assigned to a particular product recall to indicate the relative degree of health hazard presented by the product being recalled. See Attachment A for examples.

1. Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
2. Class II is a situation in which use of, 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 is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences

5.5.Consignee: Anyone who received, purchased, distributed or used the product being recalled.

5.6.Federal Partners: Refers to U.S. Food and Drug Administration and/or the United States Department of Agriculture. In the majority of cases, a food product will fall under the lead federal agency’s jurisdiction and the GDA will support any recall investigations as needed.

5.7.Depth of Recall: The level of product distribution to which the recall is to extend:

1. Consumer/User level: All end users of a product including households and all levels of distribution (i.e., hotels, restaurants, and other food service institutional consignees.
2. Retail level: This includes all retail sales of the recalled product.
3. Wholesale level: This is the distribution level between the manufacturer and the retailer. This level may not be encountered in every recall situation (e.g., the recalling firm may sell directly to the retail or consumer level).

5.8.Scope: This defines the amount and kind of product in question (i.e., products of a specific lot number produced during a specific date range). Distribution of the product can also be a factor in determining the scope of the recall.

5.9.Correction: The repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a product without its physical removal to some other location.

5.10.Product: An article subject to the jurisdiction of the FDA or USDA, including any food product intended for human or animal use.

5.11.Recall Effectiveness Check: Effectiveness checks assist in the verification that all known, affected consignees have received notification about a recall and have taken appropriate action. The firm has an obligation to conduct recall effectiveness checks as part of its recall strategy.

5.12.Audit Check: A personal visit, telephone call, email or letter (or combination thereof) to a consignee of a recalling firm, or user or consumer in the chain of distribution made to verify all consignees at the recall depth specified by the firm’s recall strategy have received notification about the recall and have taken appropriate action. Audit checks are selectively carried out by food regulatory agencies, separate from the effectiveness checks of the recalling firm, to assess the adequacy of a firm's recall effort.

1. PROCESS AND PROCEDURES
2. Product Recall Triggers
   Issues that can trigger a product recall include:

1. Epidemiological evidence demonstrating that a product may be linked to an outbreak;
2. Laboratory results indicating that a product is contaminated and may be potentially hazardous;
3. Regulatory evidence obtained during a facility inspection;
4. Industry monitoring with mandatory reporting of a positive under a firm’s internal testing; and/or
5. Consumer complaint investigations indicating that a product may be potentially hazardous.

6.2.Consumer Complaint Investigations
When the GDA receives a consumer complaint it is documented by the GDA Food Safety Consumer Complaint Specialist. Currently, all complaints are registered via phone, on the Consumer Complaint Line at 404-656-3621. For additional information, please review the GDA’s Consumer Complaint Procedures Protocol Document.

6.3.Initiation of a Recall
The GDA does not have the authority to mandate a recall. Typically, recalls are voluntary actions carried out by the manufacturer or distributors of the food product. In some cases, the firm will discover a product is defective or misbranded and conduct a recall entirely of its own volition; in other cases, the GDA will notify FDAand the company that one of its products is defective. If the company does not recall the product, the GDA and/or federal partner may seek legal action, which can include product withhold or seizure of product, including public notification of risks associated with the product. FDA may take authority to mandate recalls under its authority.
Recalls in Georgia are done in collaboration with FDA district offices, including the FDA District Recall Coordinators (DCR), whoserves as the primary contact for industry. A complete listing of DCR’s is available at:

6.3.1.Recall Inspection: In some cases, the GDA may coordinate with federal partners on a recall inspection; however, the federal partnerwill serve as the lead agency for a recall in the State of Georgia.

6.3.2.Classification and Strategy: The Center for Food Safety and Applied Nutrition (CFSAN) classifies recalls and notifies the FDA-DO of the classification.
In some cases, the GDA may coordinate with federal partners to classify the recall after assessing the health hazard presented by the recalled product; otherwise, the lead federal agencywill formalizeall recall actions and provide the firm with a recall letter.

6.3.3.Notification and Public Warning: For recalls mandated or formally requested by the lead federal agency, FDAprovides written notification to the firm that their action meets the definition of a recall with specification of the hazard level (Class I, II or III) of each product under recall. FDA assesses the need for public notification, usually in the form of a press release, which may be issued by the recalling firm and/or by FDA. As appropriate, primarily for Class I recalls, recall announcements will be posted online at or
The GDAwillpublish recall announcements through social media outlets (currently, Twitter @GDAFoodSafety). While it is the firm’s responsibility to ensure distribution of the press release, the GDA will assist the firm in formulating and distributing the recall message within its borders to the appropriate media channels.

6.3.4.Monitoring Recalls: The GDA will assist the lead federal agency, upon request or as-needed, in monitoring recalls in the event it is necessary to re-inspect the firm between the initiation and closeout of a recall to monitor its progress and verify the recalled product’s disposition. These visits are limited inspections.

6.3.5.Auditing Recalls: The GDA will implement a recall audit strategy toassist federal partners in assessing the adequacy of the recall and to ensure the recall action has been effective for the product(s) distributed within GDA jurisdiction. This will be done at random when a distribution source has been confirmed, and time and resources allow for Food Safety Inspectors to work with the Recall Outreach Specialist in conducting a recall audit. FDA may request GDA assistance in conducting a recall audit check. The GDA will use FDA 3177 as the reporting mechanism in order to accurately collect the necessary information to ensure the effectiveness of the recall. The need for, and the number of, audit checks to be conducted should be prioritized based on the level of health hazard, the remaining amount of product that may exist in the marketplace and the recall effectiveness data.

6.3.6.Termination of a Recall: After the firm has provided FDA with its final report, indicating the recall is complete, the FDA-DO will review the information along with all audit checks. If the recall has been deemed effective, the FDA-DO notifies the CFSAN and recommends the recall be closed. Once approved for termination, the FDA will provide written notification to the recalling firm. The GDA may assist FDA and work with industry partners to terminate recalls for products sold exclusively within Georgia’s boundaries.

6.4.Immediate Risk Management Decisions
If a product is still on-site at the firm/facility, the GDA inspector on site can control the product by:

6.4.1.Seizure of Existing Product:FDA has the authority to seize or embargo foodproducts. The state does not have that authority; however, GDA may enact withhold from sale or destruction of final disposition of condemned goods more expediently and with fewer legalobstacles. The GDA and FDA-DO should be aware of each other’s authorities and work collaboratively to ensure these actions are initiated as quickly and effectively as possible to control potentially hazardous food products.

6.4.2.Limitation of Future Production: The GDA may limit the products a firm may produce temporarily or permanently through license limitation, revocationor other means. FDA in coordination with the GDA (and local agencies when applicable) should determine if production limitation will be the most expedient control.

6.4.3.Control of Product in Distribution:If product has not left the direct control of the firm, it is possible for the firm to control the product using procedures other than a recall by performing a stock recovery operation. When product is in commerce and has left the direct control of the firm, it is necessary to conduct a recall to regain control of the product. The GDA and FDA will coordinate actions for best use of each organization’s staff and resources in exercising appropriate regulatory controls over recalled products.

6.5.Recall Strategy
Depending on the product's degree of hazard and extent of distribution, the recall strategy will specify the “depth of recall,” or level in the distribution chain to which the recall extends, i.e., wholesaler, retailer, user/consumer. If the recall extends below the wholesaler depth, the recall strategy should ensure that wholesalers conduct sub-recalls of the product to the appropriate recall depth.

6.5.1.Food and recalls require specific information be obtained from firms that have used recalled material in the production of another product. This is necessary to decide if the recall must be extended to any additional product(s). In those instances, the following areas should be covered during the recall investigation:

1. Determine what the firm's quality control procedures are for incoming ingredients.
2. Ascertain the quality control over ingredients at the time of use and obtain a list of the products in which the ingredients are used.
3. Obtain a detailed description of the methods used in the preparation and packaging of the processed product.
4. Determine how the finished product is stored and shipped.
5. Obtain copies or photographs of the labeling of the product and any cooking instructions for the consumer or purchaser.
6. Determine what quality control testing is done on the finished product and detail any test(s) performed by firm.
7. For products produced in USDA plants, determine if the USDA was notified of the suspect incoming ingredient? If notification was provided, did USDA determine what testing was done by the firm?
8. Determine the impactof any additional manufacturing processes on adulterated ingredients:
9. If the firm incorporated an adulterated ingredient into a new product, assess whether the manufacturing process of the new product mitigated the adulteration.
10. If the ingredient was contaminated with a pathogen, was there a validated kill step for the pathogen during the manufacture of the new product?
11. If the ingredient was adulterated with extraneous material, was there a step, like sifting, that could have eliminated the extraneous material?
12. For those ingredients that are misbranded, is there labeling on the finished product that could mitigate the misbranding of the ingredient? (i.e., the ingredient may be contaminated with peanut residue, but if the finished product is meant to and labeled as containing peanuts, then the misbranding of the ingredient is mitigated).

6.5.2.Federal Role: Federal agencies have established protocols for obtaining information necessary to both classify and determine the necessary depth of recall, need for public notification, etc., and may coordinate with GDA officials to collect it. The lead federal agency may notify the firm of the classification and necessary changes in its recall strategy, including the need for press releases for those recalls conducted voluntarily.

6.5.3.State Role: The GDA, working in conjunction with federal partners, may also notify firms within our jurisdiction of the classification and the need for press releases for those recalls conducted voluntarily. When appropriate, the GDA may assist the firm with composing the press release language and may coordinate with the federal partner to ensure all parties have a clear understanding of the recall message. Additionally, the GDA may issue a press release announcing the recall of the product in their state.

6.5.4.Intra/Inter-Agency Sharing: Local, state and federal authorities should have 24-7 contact information for their own and each other’s staff. Contact lists for the GDA is updated annually to ensure the appropriate information is available. Memorandums of Understanding regarding commercially confidential information allows for open, accurate and rapid information sharing between agencies.

FDA also has the ability to share investigatory and/or pre-decisional information with GDA personnel who have signed 20.88 Confidentiality Commitment Agreements or are commissioned through the Federal commissioning procedure. The current FDA commissioning policies and procedures grant specific authority in a specific program area to GDA personnel pursuant to the following laws: Section 702(a) of the Federal Food, Drug, and Cosmetic Act; Section 360 E(2) of the Public Health Service Act; and authority delegated to the Commissioner of Food and Drugs by the Secretary of Health and Human Services under 21 CFR 5.35.