Food Recalls:Planning & Preparedness Procedures

Table of Contents

1. PURPOSE2. SCOPE3. BACKGROUND4. RESPONSIBILITY5. DEFNITIONS6. RECALL PROCEDURES7. RELATED DOCUMENTS8. EQUIPMENT/MATERIALS9. SAFETY10. CIRCULATION11. 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.

2. 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.

EQUAL OPPORTUNITY EMPLOYER

Georgia Department of Agriculture

Gary W. Black, Commissioner19 Martin Luther King Jr. Drive, SW · Atlanta, Georgia 30334-4201

www.agr.georgia.gov

3. 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.

4. RESPONSIBILITY

4.1. Program Managers – The Manufactured Food and Retail Food Program Managers will review and issue final approval of all food program policies and procedures.

4.2. 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.

4.3. 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.

4.4. 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.

4.5. 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.

4.6. 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.

4.7. 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.

5. DEFINITIONS

5.1. 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.

5.2. 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.

5.3. 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.

5.4. 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.

a. 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.

b. 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.

c. 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:

a. 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.

b. Retail level: This includes all retail sales of the recalled product.

c. 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.

6. PROCESS AND PROCEDURES

6.1. Product Recall TriggersIssues that can trigger a product recall include:

a. Epidemiological evidence demonstrating that a product may be linked to an outbreak;

b. Laboratory results indicating that a product is contaminated and may be potentially hazardous;

c. Regulatory evidence obtained during a facility inspection;d. Industry monitoring with mandatory reporting of a positive under

a firm’s internal testing; and/ore. Consumer complaint investigations indicating that a product may

be potentially hazardous.

6.2. Consumer Complaint InvestigationsWhen 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 RecallThe 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 FDA and 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), who serves as the primary contact for industry. A complete listing of DCR’s is available at: www.fda.gov/Safety/Recalls/IndustryGuidance/ucm129334.htm.

6.3.1. Recall Inspection: In some cases, the GDA may coordinate with federal partners on a recall inspection; however, the federal partner will 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 agency will formalize all 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, FDA provides 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 www.fda.gov/Safety/Recalls or www.fsis.usda.gov/Fsis_Recalls.

The GDA will publish 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 to assist 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 DecisionsIf 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 food products. 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 legal obstacles. 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, revocation or 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 StrategyDepending 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:

a. Determine what the firm's quality control procedures are for incoming ingredients.

b. Ascertain the quality control over ingredients at the time of use and obtain a list of the products in which the ingredients are used.

c. Obtain a detailed description of the methods used in the preparation and packaging of the processed product.

d. Determine how the finished product is stored and shipped. e. Obtain copies or photographs of the labeling of the product and any

cooking instructions for the consumer or purchaser. f. Determine what quality control testing is done on the finished product and

detail any test(s) performed by firm. g. 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?

h. Determine the impact of any additional manufacturing processes on adulterated ingredients:

i. If the firm incorporated an adulterated ingredient into a new product, assess whether the manufacturing process of the new product mitigated the adulteration.

ii. If the ingredient was contaminated with a pathogen, was there a validated kill step for the pathogen during the manufacture of the new product?

iii. If the ingredient was adulterated with extraneous material, was there a step, like sifting, that could have eliminated the extraneous material?

iv. 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.

Through the Georgia Food Safety Task Force, the GDA is able to establish routine meetings between federal, state and local personnel who are involved in recall coordination activities, in order to share informational updates and maintain lines of communication.

Additional outreach and communication coordination among state and federal partners is achieved through FoodSHEILD for confidential or potentially sensitive information. Key information for agencies to share includes:

a. Any facts regarding epidemiological and/or lab information on health risk, product contamination and/or reported illnesses or injuries;

b. Preliminary product information linked to illnesses or injuries and any positive sample results or other problems warranting a recall; and

c. Information regarding the company or companies involved, their contact information and location and the scope of the proposed recall, if known.

6.6. Initial Investigation and Data CollectionGDA and FDA should collaborate on investigation and data collection at the firm if there is shared regulatory jurisdiction, or alternatively, determine which agency is in the best position regarding available resources to investigate at the firm. In most cases, an establishment inspection should be conducted to determine the root cause(s) of the problem and document violations for possible regulatory action if appropriate, if corrective action is not being implemented, and evaluate overall compliance.

6.6.1. Prior to initiating an establishment inspection, the GDA should determine whether similar complaints have been entered into the DHD database system. The establishment inspection should, in addition to other activities:

a. Obtain the recalling firm's proposed recall strategy [21 CFR 7.46(a)], if not previously submitted by the firm.

b. Collect copies of all labeling associated with the product. c. Obtain complete distribution of all shipments of the suspect lot(s),

including complete names and addresses of all consignees. d. Obtain supporting documentation that will assist the agency in identifying

and evaluating the problem such as product complaints, product specifications and test results, including the methods used to obtain the results.

e. Assess the root causes of the problem to determine how and when the problem occurred and how and when it was discovered. Obtain the firm’s corrective action plan, which addresses preventing future occurrences.

f. Verbally tell the firm's management that the FDA Recall Coordinator and/or GDA officials should be consulted prior to the reconditioning or destruction of any returned product. Management should also be advised that a GDA Food/Feed Inspector should witness or otherwise verify product disposition.

6.7. Industry CommunicationIf/when a firm identifies a sample with a product, it must notify the GDA. If the finished product testing indicates a positive result, GDA must be notified within 24 hours of the results. If it becomes an industry-initiated recall directly by the firm, the firm and/or GDA should immediately notify the FDA DRC and District Compliance Branch Director via telephone or email.

Registered facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. are required to report when there is reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animals under section 415(a) of the FD&C Act (21 U.S.C. 350d). This information is submitted through an electronic portal called the Reportable Food Registry (RFR). The RFR applies to all FDA regulated categories of food, except dietary supplements and infant formula. It is important to note that a report filed through the RFR does not always result in a product recall.

6.8. Public Notification and Press ReleasesThe recalling firm has a responsibility to provide information when there is a need to alert the public to a serious hazard presented by exposure to the firm’s product(s). GDA should work with the firm, as needed, to ensure the public message clearly identifies the products and the potential risk involved. Public notification is important, particularly in situations where the recalled product may pose a significant health hazard and may already be in the hands of consumers. In such situations (often Class I and sometimes Class II recalls), prompt issuance of a press release should be high priority, with unique situations handled on a case-by-case basis.

When public notification is necessary, FDA and sometimes GDA will work with firms initiating a recall to issue a press release as soon as the recall situation has been identified. If appropriate, the firm should consider alternative forms of communication through licensees and other partners (e.g., schools, hospitals, etc.).

If and when FDA issues a press release, the GDA may consider using that release’s same verbiage for its own release to be issued and provided to relevant media outlets across the state.

6.8.1. The essential elements of a press release should include the following:

a. Establishment – The name and address of the firm with points of contact for additional recall information (e.g., firm’s website, recall manager/coordinator, media inquiries, consumer inquiries, etc.) with phone and fax number(s) including days and times (with time zone) when the consumer lines of communication are open;

b. Product – Exact and complete description of the specific product(s) recalled including type of packaging and sizes;

c. Production Dates and Codes – Specific identifying codes or marks on the packages along with specific dates of production including plant codes, sell-by dates, expiration dates and location of codes on the package;

d. Quantity – The amount of product under recall; e. Recall Classification – Class I, II, or III if information is available

(typically press releases are issued before the recall has been classified, so this information may be unavailable);

f. Recall Notification Level – Wholesale, retail and/or consumer; g. Reason for Recall – The problem with the product or the

reason for the recall along with the specific nature of potential hazards (e.g., allergic reaction, infection, etc.), including indication as to whether there have been any illnesses or injuries associated with the recalled product;

h. Discovery – Details regarding how and when the hazard was discovered;

i. Distribution – Geographic depth of the product distribution, including whether it was international, nationwide, statewide or to specific counties, and if possible, names of retail chains that have carried the product;

j. Media and Consumer Contacts – Two different contacts are usually given, with instructions to the public regarding typical symptoms of illness and what to do with the recalled product if they have it,

k. Risk Information – Succinct information about specific steps consumers can take to reduce their risk of illness (e.g., an explanation of the risk involved in consuming the product, including typical signs and symptoms of adverse health effects); and

l. Follow-up Activities – A statement regarding the status of the investigation and agencies involved, as appropriate (e.g., “the firm is cooperating with the investigation by state and federal officials to identify the source of contamination”).See the following attachments for additional guidance: Attachment B, Example Press Release; Attachment C, Example Customer Notification Letter; and Attachment D, Examples of Contamination or Hazard Warning Language.

6.9. Recall EffectivenessEffectiveness checks assist in the verification that all known, affected consignees have received notification about a recall and have taken appropriate action with the recalled product.

It is up to the recalling firm to determine whether its recall is progressing satisfactorily. The firm has an obligation to conduct effectiveness checks as part of its recall strategy; however, in some instances, a recalling firm may be unable to check the effectiveness of its recall, which can happen when: A recall extends to the consumer/user level; the confidential business records of a firm's customers are not accessible; wholesalers, distributors, or retailers do not cooperate; or because the urgency of the situation requires an all-out effort. In such cases, GDA may assist in the recall effectiveness checks and seek assistance from cooperating state and local agencies when appropriate.

By conducting internal recall audit checks above and beyond requested assistance, inspectors will become more comfortable with the process and the use of FDA 3177 form. See Attachment E.

6.9.1. Recall Audit Checks:Recall audit checks are made to verify everyone within the depth of the recall has received notification about the recall and has taken appropriate action. Generally, within 10 days of issuing a firm’s recall communication, the FDA-DO will issue audit check assignments at the appropriate level. Exceptions to the 10-day time frame may be for Class I situations, when the recall is to the consumer/user level and it is critical that products are removed from market or that consumer/users have

been notified of the recall action. Audit check assignments can include requesting GDA assistance.

The GDA will also conduct its own recall audit checks on a random, routine basis, utilizing FDA 3177 form. GDA will coordinate any independent audit check efforts with the FDA-DO to avoid duplication of effort. When audit checks have been completed and reviewed, the Recall Outreach Specialist will share the data with the FDA DRC, including a summary of how the data was gathered and how to interpret it.

6.9.2. Information to Obtain During an Audit Check:

a. Name and title of person interviewed;b. Verification that notification was received, understood and

followed;c. Date and method of notification (in person, phone, fax, letter,

etc.);d. Amount of recalled product on hand at time of notification

AND amount presently on hand and its status (held for sale, awaiting return, etc.);

e. Date of anticipated return or destruction, and planned method (if applicable)

f. Amount returned and the method of return or amount destroyed and method of destruction;

g. Was a sub-recall conducted? If so, obtain a list of consignees from which to select your sub-recall check locations; and

h. Have injury reports or complaints been received? If so, report details. See: FDA Recall Audit Check Form 3177 (Attachment E) for additional guidance. Also review additional SOPs: 2014 - Guidance Doc for INSPECTORS - Traceback Investigations Job Aid, and 2014 - Guidance Doc for INSPECTORS - Recall_RFR Checklist.

6.9.3. Level of Audit Checks (IOM 7.3.2.2):

a. Level A – 100 percent of the total number of consignees is contacted.

b. Level B – More than 10 percent, but less than 100 percent, of the total consignees is contacted.

c. Level C – Ten percent of the total number of consignees is contacted.

d. Level D – Two percent of the total number of consignees is contacted.

e. Level E – No audit checks are being conducted.

6.9.4. Information to Determine the Level of Audit Check:

a. Recall Classification Level (I, II, or III)b. Depth of product distributionc. Likelihood that product is still in commerced. Reports of confirmed illness linked to the producte. Target population group likely to consume product

6.9.5. Ineffective Recalls: If an audit check finds recalled product still being held for sale, or a requested sub-recall has not been initiated, inspectors should document the firm’s failure to follow recall instructions. In these instances, product should always be removed from sale before the audit check is completed.

6.9.6. Termination of Recall: A recall can be terminated once CFSAN and FDA, in conjunction with GDA, determines all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, including the reasonable assumption that the recalled product has been removed from sale with proper disposition or corrective acts made. GDA inspectors may be requested to perform post-recall inspections or sampling to ensure corrective actions have been complete and the firm is back in full compliance.

6.9.7. Recall Completed: For monitoring purposes, FDA classifies a recall action "Completed" when all reasonably expected outstanding product is recovered, impounded or corrected.

6.9.8. Documenting Effectiveness: For large scale events, it may be helpful to include recall activities and issues in the “After Action Report” (Hotwash Activity).This provides a mechanism for documenting issues encountered with the recall procedure and provide opportunity to review and revise the procedures as needed. The recalling firm should have an approved recovery plan (restoration plan) to correct issues and restore operations to full compliance. Firm will submit plans to GDA and FDA.

7. RELATED DOCUMENTS (includes References, Attachments):

Attachment A: Examples of Recall SituationsAttachment B: Example Press ReleasesAttachment C: Example of a Customer Notification LetterAttachment D: Recommended Wording for Specific ContaminantsAttachment E: Recall Audit Check Form 3177Attachment F: Alert to Recall and Attachment B GuidanceAttachment G: Example of a Recall Flow Diagram

8. EQUIPMENT/MATERIALS NEEDED

Inspection equipment listing (training materials or evaluation listing).

9. SAFETY

All GDA employees must follow the personal protective equipment requirements and field safety guidelines during a recall investigation. Never enter an area or perform any job task that you think will result in injury or illness. If you identify unsafe conditions, STOP the investigation and consult with facility management or your supervisor regarding a corrective action for the hazard(s). Lastly, stick to the specific focus of your position and as always, THINK SAFETY! Before performing an inspection, ask firm about any physical or chemical safety issues in the firm. If the inspector has concerns about in-facility safety, they should contact their supervisor IMMEDIATELY.

10. CIRCULATION

This document is circulated to the following: Food Processing Program Specialist, Food Processing Program Associate, Manufactured Food Program Manager, Retail Food Program Manager, Ag Inputs (Feed) Manager, Compliance/Enforcement Manager, Compliance Officer, Regulatory Affairs Manager, Training Coordinator, Recall/Outreach Coordinator, Chief Security Officer and staff, RRT Leaders and Members, Chief Communications Officer and staff, Assistant Division Director and Division Director.

11. APPROVAL/DOCUMENT HISTORY

Document HistoryVersion

#Status(I, R)

Change History

12

34

IR

RR

Initial Policy Drafting by Jessica Badour 1/15/13Updates by Jessica Badour incorporating feedback from Brandon Sauceda, Venessa Sims, Krissa Jones 7/11/13Trained on Policy 7/26/13Updated from “draft” to “final” version 4/1/14

Approved By: DateNatalie Adan 4/1/14

I = Initial document; R = Revised document

Attachment A: Examples of Recall Situations

Examples of Class I, II, and III Recall Situations

Recall classifications often occur on a case-by-case basis. Certain hazards may be classified as Class I, II, or III depending on circumstances and risk. Each unique situation cannot be captured in list format; therefore, the following list is a guide only and represents the most common classifications for the hazards listed. When Georgia is assisting with a recall, FDA is consulted as appropriate to assure proper recall classification.

Class I RecallsClass 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.

· Listeria monocytogenes in certain ready-to-eat foods· Clostridium botulinum toxin· Shiga toxin producing Escherichia coli including E. coli O157:H7

(as well as non-O157 Shiga toxin producing strains (STECs))· Salmonella sp. in ready-to-eat food and pet food or pet treats· Uneviscerated salt-cured, dried or smoked fish products greater

than 5-inches in length (FDA Compliance Policy Guide 540.650)· Foods containing undeclared sulfites at a level greater than 10 mg

per serving· Foods containing an undeclared allergen ingredient that contains

protein derived from any of the following (for further information on labeling foods containing allergens, click here):

o Milko Eggo Shellfish or fisho Tree nuts (chestnuts, Brazil nuts, walnuts, hazelnuts,

pecans, pine nuts, cashews)o Peanutso Soybeanso Sulfites

Class II RecallsClass 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.

· Undeclared coloring agents such as FD&C Yellow No. 5 (see 31 CFR 101.22 (k)(3) for additional requirements)

· Undeclared wheat· Certain situations where a pathogen risk in food is likely to be

mitigated by a heat-kill/processing step performed by the consumer/user (i.e., Salmonella in tea intended to be prepared using boiling water)

· Norovirus· Adulteration with hard or sharp foreign objects such as plastic,

glass or metal pieces· Histamine in seafood· Undeclared wheat allergen

Class III RecallsA situation in which use of or exposure to a violative product is not likely to cause adverse health consequences

· Undeclared certified coloring agents, other than yellow 5 (see CFSAN and FDA Federal Food, Drug and Cosmetic Act, section 721 (a)).

· Decomposition, which does not result in health hazard such as histamine

· Filth, which does not result in health hazard· Products which are unfit for food based on off-odor or off-taste,

but do not pose a hazard to health· Minor labeling problems (i.e., format, undeclared ingredients that

are not allergens)

Attachment B: Press Release Samples

Sample 1: Release Issued by the Firm

<Company Name><Company Address><Company City, State, Zip>

FOR IMMEDIATE RELEASE <Date of Release>

<Company Name, Title, Phone>

<Descriptive Title of Recall>

<City, State> -- <Company Name, Address> is recalling <specific product(s)> because the product <specific reason for the recall; include pathogens associated with contamination or any other reasons associated with the recall description.> <Hazard statement related to the recall; note: the phrase “potentially harmful” is NOT adequate to express the nature of the hazard for a Class I recall.>

The recalled <product> was distributed to <complete distribution description including cities and/or states, or specific stores or distribution sites.> <Specific product description should include UPC and/or lot code, packaging description, location of coding on the package, expiration or other dates.>

To date, there <have/have not> been <number> of illnesses reported in connection with this recall.

The contamination was noted after testing by the Georgia Department of Agriculture <or FDA/USDA> revealed the presence of <pathogen or issue with the product> in some < produce description>. Production of the product has been suspended while <Company Name, the Georgia Department of Agriculture and federal officials> continue their investigation into the source of the problem.

Consumers who have purchased <produce description> are urged to return the product to the place of purchase for a full refund. Consumers with questions may contact <Company Name, phone and/or email with operational business hours and time zone>.

###

Attachment B: Press Release Samples

Sample 2: Release Issued by Georgia Department of Agriculture

Georgia Department of AgricultureGary W. Black, Commissioner

19 Martin Luther King Jr. Dr. SW, Atlanta, GA 30334www.agr.georgia.gov

Press Release – For Immediate Release<Date>Office of Communications404-656-3689

N.C. company recalls tempeh after tests detect salmonella

Agriculture Commissioner Gary W. Black is alerting Georgians to the recall of some tempeh products distributed in Georgia because the product may be contaminated with Salmonella. Georgia Department of Agriculture inspectors will be checking local stores to make sure the recalled products are removed from sale. Here is the recall announcement from the FDA: Smiling Hara of Asheville is voluntarily recalling 12-ounce packages of unpasteurized soybean tempeh because of possible contamination with salmonella. The company is recalling tempeh manufactured this year between Jan. 11 and April 11. The containers are marked with a best-by date of 7/11/12 through 10/25/12. Tempeh is used as a meat substitute in vegetarian cuisine. The company is directing consumers to return the product to the place of purchase for a full refund. Consumers wanting more information can contact Smiling Hara at 828-242-1300. Smiling Hara launched the recall after samples collected by the North Carolina Department of Agriculture and Consumer Services during a routine inspection tested positive for salmonella. Additional tests will be conducted by the North Carolina Division of Public Health. Symptoms of Salmonella commonly associated with this infection may include, but are not limited to, diarrhea that may be bloody, fever, headache and abdominal pain usually one to 10 days after exposure. The illness caused by salmonella infection usually lasts four to seven days, but can last longer. For more information: Consumers with questions about the recall should contact Smiling Hara’s customer relations at 828-242-1300. Media with questions about the recall should contact Brian Long at 919-707-3007 or Mark Van Sciver at 919-855-4840. Questions for the Georgia Department of Agriculture should be directed to <Chief Communications Officer Name, phone, email>.

###About GDAThe Georgia Department of Agriculture (GDA) is the voice of the state’s agriculture community. The department's mission is to provide excellence in services and regulatory functions, to protect and promote agriculture and consumer interests, and to ensure an abundance of safe food and fiber for Georgia, America, and the world by using state-of-the-art technology and a professional workforce. For more information, visit, www.agr.georgia.gov.

Attachment C: Example of Customer Notifications

Sample 1: Letter

<Company Name><Company Address><Company Phone Number><Date>

<Customer/Consignee Firm Name><Customer/Consignee Firm Address>ATTENTION: <Contact Person Name, Title>Re: RECALL OF <Type of Product>

Dear Sir or Madam:

This letter is to confirm that <Company Name> is recalling the following product(s) because<specific reason for the recall>.

<Specific product description: Include name, brand, UPC and/or lot code, packaging size and description, establishment number, etc.>

We request that you review your inventory records and immediately discontinue selling any existing stock of this product. Please segregate the <recalled products> and <indicate proper disposition> as soon as possible. We will credit your account for product returned.

We are undertaking this action in cooperation with the <Regulatory Authorities> and state and federal officials may contact you to confirm that you have received this notice and are cooperating in this action.

Your prompt action will greatly assist <Company Name> in this action. If you have any questions, please do not hesitate to contact <Company Recall Coordinator> at <phone and email>. Thank you for your cooperation.

Sincerely,<Company Official’s Name, Title>

During Class I Recalls, there is additional content that should be included with the letter:

In order to advise the <Georgia Department of Agriculture and/or FDA and/or USDA> about the effectiveness of this recall, please inform us of the quantity of the <recalled product> on hand immediately after receiving this recall letter and reviewing your inventory.

Please sign this letter and scan to email or fax back to <fax number> as soon as possible.

Quantity on Hand: _______________ Cases/Cans/Packages (Please circle one)

Signed,<Store Owner>

Attachment C: Example of Customer Notifications

Sample 2: Store-Issued Notification

Voluntary Recall Notice

To: <Store Name> Customers and EmployeesFrom: <Store Owner’s Name>Date: <Current Date>

We were notified on <date> that traces of <adulterant> were present in <Product Name> produced on <date(s)> in our store. We believe this to be an isolated occurrence that only affected this one batch. To date, we have had no other reports of <adulterant> in any additional products and are cooperating fully with the Georgia Department of Agriculture and federal officials investigating this event.

If you have any <Product Name> with a packed on date of <date> and a sell-by date of <date>, please return it to <Store Location and Address> for a full refund.

We appreciate your business and if you have any further questions, please feel free to call <Store Owner Name> at <phone> or Store Director <Name> at <phone>.

Thank you for your patronage,

______________________<Store Owner>

Attachment D: Recommended Wording for Common Contaminants

E. coli 0157:H7: Infections can cause watery diarrhea (bloody or non-bloody), dehydration, abdominal cramps, vomiting, and in severe cases a serious condition involving kidney failure called hemolytic uremic syndrome (HUS). The very young, the elderly, and persons with compromised immune systems are the most susceptible to foodborne illness. People experiencing these problems should seek immediate medical attention. Onset time after ingesting is one to three days.

Listeria monocytogenes: Consumption of food contaminated with Listeria monocytogenes can cause listeriosis, an uncommon but potentially fatal disease. Listeriosis can cause high fever, severe headache, muscle aches, diarrhea, and nausea. Listeriosis can also cause miscarriages and stillbirths. The very young, the pregnant, the elderly, and persons with compromised immune systems are the most susceptible to infection. People experiencing these problems should seek immediate medical attention. Onset time is unknown but may range from a few days to three weeks.

Clostridium botulinum: Botulism, a potentially fatal form of food poisoning, can cause the symptoms of general weakness, vomiting, diarrhea, dizziness, descending flaccid paralysis, double vision and trouble speaking or swallowing. Difficulty in breathing, weakness of muscles, abdominal distension and constipation can also be common symptoms. The very young, the elderly, and persons with compromised immune systems are the most susceptible to foodborne illness. People experiencing these problems should seek immediate medical attention. Onset time after ingesting is 12 to 72 hours.

Salmonella: Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstance, infection can result in the organism getting into the bloodstream and producing more severe illnesses, such as arterial infections (infected aneurysms), endocarditis and arthritis. The very young, the elderly, and persons with compromised immune systems are the most susceptible to foodborne illness. People experiencing these problems should seek immediate medical attention. Onset time after ingesting is 6 to 48 hours.

Allergens: People with severe sensitivity or allergic reactions to a specific type of allergen (i.e., peanuts, tree nuts, eggs, sulfites, milk, etc.) run the risk of a serious or life-threatening allergic reaction if they consume these products. Most severe allergic reactions occur within seconds or minutes after exposure; however, some reactions can occur after several hours, particularly if the allergen causes a reaction after it has been eaten. In very rare cases, reactions develop after 24 hours.

Attachment E: FDA Recall Audit Check Report Form 3177

To complete Form 3177:

1. Recall Information:

a) RES/Recall Number – Assigned by FDA. If available, enter the recall number assigned (or leave blank); if more than one number is involved, enter the lead number.

b) Recalling Establishment – Name and address of the firm responsible for issuing the recall notification, this MUST be filled in for the audit to be credited to the recall.

c) Recalled Codes – Provide lot, batch, or serial number under recall. d) Product – Provide the name of the product under recall (if numerous products are

involved, use generic terms, such as ice cream, dried fruit, etc.).

2. Program Data:

a) Only complete the “Hours” section of this box (recording the hours spent on-site or on the phone conducting the audit check). Most of the other fields in this section will be filled in by FDA.

3. Audit Accounts: (Note that not all audits will go all the way down to the tertiary level, based on distribution. Complete address and contact information for each account identified as part of the distribution to the consignee.)

a) Direct Account – The firm that received the recalled product directly from the company who has issued the recall.

b) Secondary Account – Any firms that received recalled product from the “Direct Accounts” listed in 3a.

c) Tertiary Account – Any firms that received recalled product directly from the “Secondary Account” in 3b.

4. Consignee Data: "Consignee" is the account at which the audit check is being conducted; it can be a retail facility, distributor, food bank, etc. and is considered to be the last facility in the distribution chain listed on the audit.

a) If the audit check is being conducted at the “Secondary Account” facility, they are considered the Consignee, and both the Direct Account and Secondary Account address and contact information should be shown on the audit form.

b) If the consignee currently has, or has had, the product in stock during the time frame covered by the recall, 4c would be marked “Yes.”

c) If the consignee has further distributed product and a sub-recall is needed to reach the appropriate recall depth, obtain a copy of their distribution list for the recalled product.

5. Notification Data:

In Box 5 (a-d), each section must have a checkbox completed and the detail of how the firm was notified.

a) Did consignee receive a specific written, verbal or personal contact providing recall notification?

b) From whom and when was notice received? c) If they only heard about it from the media, include this information.

6. Action and Status Data:

a) Did the consignee follow the directions received from their supplier/recalling company regarding what to do with the product? If ‘no,’ record the consignee explanation along with any other findings in Block 10.

b) Record the amount the consignee said they had when they received notification of the recall (NOT the amount they have when you contact them, you’ll include this info in another block); if firm can’t remember how much they had, document ‘not available.’ If they didn’t have any when they were notified, enter ‘none.’

c) Record information for product both on-site at time of audit as well as product they may have disposed of or sent back to the supplier.

d) Document the firm’s actions to the best of their recollection.

7. Sub-Recall Needed: If consignee supplies/supplied product to other accounts, then they may need to do a sub-recall in order to meet the appropriate recall depth. The inspector should mark item 7 ‘Yes.’

a) If the firm needs to do a sub-recall, obtain a copy of the distribution list for all of the recalled products and describe firm's sub-recall procedures in Block 10 ‘Remarks.’

b) The inspector may also be asked to complete Attachment B information if directed by a supervisor and submit all information collected.

c) If firm has refused to sub-recall properly without justification, include the GDA’s follow-up actions in Block 10 and give reason why firm states they refuse to conduct a sub-recall. Mark “Ineffective” or “Not Effective” in the endorsement block in the lower right hand corner.

8. Amount of Recalled Product Currently In Stock:

a) If none on hand at time of audit, document ‘none,’ please do not leave blank.

9. Injuries/Complaints and other Remarks:Provide all information not covered in 1-8 that could aids in the evaluation of recall effectiveness at this consignee.

a) CHECK Section (lower left corner of document): i. Signature of CSO/CSI: Inspector’s name goes here, preferable to

physically sign and scan document to send electronically, if possible.ii. Date of Check needs to be completed

iii. District will be provided to inspector

b) ENDORSEMENT Section (lower center/right corner):i. This section is left blank by the Consumer Safety Officer (CSO),

Consumer Safety Inspector (CSI), or field inspector for completion by the supervisor.

ii. The endorsement box needs to be completed by the supervisor with their name, statement “effective” or “not effective” and date of endorsement.

iii. Examples:· “Ineffective/Not Effective” – Audit check has found recalled

product being held for sale or a requested sub-recall has not been initiated. Document the responsibility for failure to follow recall instructions (especially important if the firm received the recall notice and ignored it). The audit check is also considered ineffective if the consignee did not receive notification from the recalling firm or distributor that sold the recalled product to the consignee.

· “Effective” – Recall notice was received from the recalling firm or distributor that sold the recalled product to the consignee and the consignee followed the instructions in the recall notification.