Recalls & Alerts
FDA recall classification categories:
Class I: there is a reasonable probability that eating the product will cause death or serious health problems.
Pathogenic organisms such as Listeria monocytogenes, Clostridium botulinum, E. coli 0157:H7, Salmonella enteritidis, undeclared peanuts or tree nuts (pecans, hazelnuts, filberts, walnuts, cashews, and brazil nuts), undeclared eggs and undeclared sulfites (10 mg or more per serving), in the product would be given this classification. Other pathogenic organisms may also be considered in this classification depending upon the specific situation, amount of product distributed, extent of product consumed, age and health of the individuals exposed, etc.
Class II: there is a remote probability that eating the product will cause serious health problems; or products that could cause temporary, reversible health problems.
Examples for this classification would be product that had pathogenic organisms, such as most Salmonella species, Shigella, Staphylococcus aureus, or indicator organisms such as generic E. coli, non-FD&C certified colors and undeclared FD&C Yellow #5 and #6, undeclared sulfites (3.7-9.9 mg per serving), undeclared wheat, oats, or corn, undeclared fish, unapproved additives, undeclared pistachios or almonds, undeclared soy (soybeans, soy protein, and soy flour), and undeclared dairy products (milk, cream, dry milk, whey). Again, depending on the specific situation, amount of product distributed, extent of the product consumed, age, and health of the individuals exposed, other pathogenic organisms may also be considered in this classification.
Class III: eating the product is not likely to cause serious health problems.
Adulterated or misbranded products that do not involve a health hazard would be given this classification. For example, undeclared certified colors (other than Yellow #5 and #6), undeclared sulfites (less than 3.7 mg per serving) and minor labeling problems (e.g. identification of a container as having 14 ounces of a product when in reality it contains only 10 ounces of product).
Any unclassified and voluntary situation of product withdrawal in which no violations are involved, or are of such a minor nature, will not place them under FDA guidelines. Examples may include product quality, nonfood safety labeling etc.
Produce Alliance Proprietary Recall System
Real Time Recall Tracking with PA Distributors
Direct Customer Contact for Product Disposition
Strict Timeline for Recall Closing and Recall Reporting
Recall, Food Safety Alert Tracking History Maintained for Review
**Food Safety Alerts are utilized to communicate to all Distributors and Customers as needed on food safety events which are not recalls but are noteworthy to the industry.
Food Safety Terms and Definitions
The Food and Drug Administration has established voluntary guidelines for conducting product recalls related to all foods. The product manufacturers or distributors carry out most recalls of product regulated by FDA voluntarily. In some instances, a company discovers that one of its products is defective (adulterated or misbranded) and recalls it entirely on its own. In others, FDA informs a company of findings that one of its products is defective and suggests or requests a recall.
FDA guidelines for companies to follow when recalling defective products under the Agency’s jurisdiction are published in Title 21 of the Code of Federal Regulations, Part 7:
These guidelines make clear that FDA expects these firms to take full responsibility for products recalls, including follow-up checks to assure that recalls are successful. Under the guidelines, companies are expected to notify FDA when recalls are started, to make progress reports to FDA on recalls, and to undertake recalls when asked to do so by the Agency.
The guidelines also call on manufacturers and distributors to develop contingency plans for product recalls that can be put into effect if, and when needed. FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. The majority of recalls are voluntary by the manufacturers or distributors even if it was brought to the attention by a governing agency. An involuntary recall is when the recall is initiated by the governing agency like the FDA executes the recall.
A product recall is the removal or correction from the channels of distribution and consumption of any product deemed to be potentially hazardous or defective. A true recall of a food product occurs only when the product violates the law and is a likely candidate for seizure, condemnation or other legal action by the government. A food product may violate the law if it is “adulterated” or “misbranded”. Whether a product defect is likely to result in government action will depend on the particular food product and the potential risk to the consuming public. Recall does not include a market withdrawal or a stock recovery.
1. A food product is adulterated if it:
- Contains a poisonous (e.g. Salmonella, E. coli O157: H7, cyanide) or deleterious substance (e.g. a piece of glass);
- Contains an unapproved pesticide or a pesticide in excess of a specific legal tolerance set by the FDA and/or the Environmental Protection Agency (EPA);
- Contains an unauthorized food or color additive;
- Contains filth (e.g. insect parts, rodent excreta) or a decomposed substance or is otherwise unfit for food;
- Was produced, prepared, packed, or stored under unsanitary conditions in which it may have become contaminated.
2. A food is misbranded if its labeling is false, misleading or does not contain information required by law. A product may be misbranded if:
- The components of the food are not fully identified in the statement of ingredients;
- The weight or volume is inaccurate or not declared properly; or
- The label does not bear the nutritional facts panel.
Market withdrawal of a product is the removal or correction from channels of distribution and consumption of any product where no legal violations have occurred, or only minor violations that under normal circumstances would not be subject to legal action, e.g. normal stock rotation practices, incorrect barcode, tampering without evidence of manufacturing or distribution problems, etc.
Stock recovery is 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. For example, the product is located on the premises owned by, or under the control of the firm, and no portions of that lot have been released for sale or use.
A product safety investigation is an internal trace of product origin/history prompted by notification by the FDA or a state health department, a customer or quality control/production personnel that there may be a potential food safety or physical defect in a specific product. The facts of the investigation will determine if a product recall, market withdrawal or stock recovery is warranted.
A mock recall is an internal exercise to test your company’s ability to trace and recall product. Mock recall exercises are scheduled on an annual basis (at least) using differing scenarios to ensure the mock recalls run smoothly. This exercise shall be documented to measure the effectiveness of the mock recall process then reviewed to identify and correct any internal problems discovered. Key elements of the mock recall documentation include scenario, time taken, accounting for affected product, documenting time line, copies of documentation that show the traceback and any lessons learned from the exercise (see Mock Recall Form).
Mock recall exercises allow you to "fine-tune" your system. How easily can you trace and recover your products? How long does it takes from deciding to carry out a recall to actually being able to inform the affect customers? How easily can you traceback the origin of a particular fresh fruit or fresh vegetable? Can you look at your lot identification records and determine which ingredients recalled products have in common? How much product is accounted for? This might include culled materials that have been sent for the production of other animal or human foodstuffs. If a supplier or grower detects a recall issue, they should contact all affected operations to which they have sold their products. This initiates a trace forward from raw material through to finish. Mocking one of these different scenarios is also useful some times.
A product code is required under Good Manufacturing Practices and provides meaningful information regarding product lot number, packing date and packing location. The product code needs to be entered on all appropriate quality control records, production reports, procurement reports and shipping reports so that the product can be traced at a later date if necessary. The out loading product code(s) is/are usually the first step back in the traceback process through the production and storage processes, through to incoming lot or lots and vice versa in a trace forward scenario
PA Not Affected: Our system showed no usage for the item selected for the distributor and custom.
PA Affected not reported: Our system showed usage for that specific distributor and customer. Have not heard from the distributor if they are involved.
PA Affected-Recall Implemented: Our system showed that the distributor had usage for the item involved in recall therefore give a deposition for each location is given for the recalled product.
PA Affected-Reported Safe: Our system had shown usage for the item for a specific distributor/customer and report not involved in the recall.
Depth of Recall: The level of product distribution for the recall (consumer, retail, institutional, wholesale).
Distribution List - A product specific distribution list which identifies accounts that received the recalled product. Requested information includes type of business, account name, addresses, and contact information.
Press Release - A notice that alerts the public (including regulators, retailers, consignees, other distributors, processors, and consumers) that a product presents a serious hazard to health. Not all recalls require a press release; the regulatory agency will advise the firm when a press release is necessary.
Recall - A firm's removal or correction of a marketed product that the regulatory agency considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. Recall does not include a market withdrawal or a stock recovery.
Recall Committee – The group comprised of key staff with the expertise, authority, and responsibility to manage the recall. PA teams is called the Recall Response Team.
Recall Plan - The Recall Plan should be reviewed annually and revised as necessary when personnel, procedures, processes, suppliers, or as other factors change.
Recall Strategy - A planned specific course of action to be taken in conducting a specific recall, which addresses the depth and scope of recall, need for public warnings, and extent of effectiveness checks for the recall.
Scope of Recall: Defines the amount and kind of product in question.
At PA we must make sure that we have a Food Safety Management System in place to ensure that we provide only the safest food available. Food Safety Management Systems have the following components, HACCP, Management Commitment, document control , Internal Audits, Training, Management Review, prerequisite programs such as sanitation, pest control, chemical, pre maintenance, glass-brittle plastic policy, personal GMPs. The goal of the FSMS is continuous improvement. This is monitored through GFSI audits. These are audits are bench marked against a standard. Some common types of these audits are: PrimusGFS, SQF, BRC, Globalgap, Canadian gap and FSSC 22000.
GAP/GHP audits: In recent years several types of fresh produce have been implicated in illnesses. Ultimately some of these outbreaks were caused by cross contamination and are the result of how the produce was handled by the end user. Troubling however for the farming community is the fact that some of the outbreaks have been traced back to the farm where the produce commodity was grown. In light of this, consumers are looking more critically at their food source and wanting reassurance that they are being provided with safe fresh fruit and vegetables. GAP and GHP procedures should be in place in hopes of shrinking the possibility of contamination. First parts of GAP are in to educate and training the farmers of how to have best practices in food safe handling. Second part of GAP is to have self-audit utilizing workbooks and record keeping. The third part of GAP are Third Party Audit Certification, an auditor visits the farm and walks through the production, harvest and transport system with the producer and verifies that GAP is being used.
Packinghouse Audits Inspections are made in the packing houses similar to the farms with special emphasis on the following, Receiving of product, washing/packing line, GMPs, Pest Control and Traceability. It is important to maintain buildings, fixtures, and other physical facilities, and their grounds, in good condition to reduce the potential for microbial, physical and chemical contamination of the produce.
Distributors Audits: Over half our PA distributors are GSFI certified with the intentions of having all GSFI inspected as soon as possible. GSFI is an industry-driven initiative providing thought leadership and guidance on food safety systems necessary for safety along the supply chain. GSFI inspections are completed by third party audits with pre-audits recommended. All this to ensure proper safe food handling.
Risk Assessment: Is exercise carried out by the producer to determine the risks involved in their whole operation. The risk assessment based upon physical, chemical and biological. Physical risks are rocks, dirt and wood. Chemicals are pesticides, cleaning compounds and grease. Biological are bacteria such as salmonella, E.coli, Listeria and some molds/aflatoxins.