Of all the potential reasons for a recall, the food safety perspective is typically the most serious.
By Adam Fahrenholz, Wilmer Pacheco, and Charles Stark
In 2019 we first shared this article on the establishment and use of recall plans. Coincidentally, around the same time the FDA issued a draft guidance on the initiation of voluntary recalls under 21 CFR part 7 subpart C. The FDA has now published the final guidance document on the topic, and so it seems like a good time to revisit recall plans and their components. The following is a general synopsis of good business practices and policies, but we certainly recommend reviewing the applicable guidance documents, collecting information from relevant trade associations, and familiarizing yourself with the regulatory language in order to best understand the requirements and expectations for creating and implementing a recall plan if it becomes necessary.
Modern feed manufacturing processes and feed quality assurance programs are designed to ensure that customers are provided with wholesome and safe animal foods. However, there may be occasions when animal foods need to be recalled due to inferior quality (high level of fines, non-uniformity in appearance, off odors, etc.), improper labeling, or because of food safety concerns. Of all the potential reasons for a recall, the food safety perspective is typically the most serious and animal foods have been recalled due to biological hazards such as Salmonella in pet foods, nutrient deficiencies or toxicities, issues with medications, or high levels of mycotoxins.
Recalls are actions taken by a company to remove an adulterated, misbranded, or violative product from the market. Having a recall plan that describes the course of action to be followed if an adulterated or misbranded product has been distributed is the best way to be prepared. According to the FDA, recalls can be classified in three ways based on the degree of health hazard presented by the product being recalled: Class I: situation in which there is a reasonable probability that the exposure or use of violative product will cause serious adverse health consequences or death to animals or humans; Class II: A priority situation involving a product that may cause temporary or medically reversible adverse health consequences to animals or humans; Class III: A situation involving a product that is not likely to cause adverse health consequences to animals or humans. In the event of a recall, companies are responsible for removing products from sale or distribution that may pose a health risk to animals or humans. Moreover, to comply with the Food Safety Modernization Act (FSMA), a facility is required to develop a recall plan if, during a hazard evaluation, the facility identified a hazard requiring a preventive control. FSMA also grants FDA mandatory recall authority to require a Class I recall, if necessary.
However, it is a good industry practice to have a recall plan regardless of the outcome of the hazard analysis. The recall plan must describe the actions to directly notify consignees/customers regarding the animal food being recalled and how to return or dispose the product, notify the public, conduct effectiveness checks to verify that customers have been notified and product has been recalled, as well as the appropriate disposition of the animal food by reprocessing, reworking, or disposing if necessary.
One of the first steps in developing a recall plan is to identify a recall management team. Depending on the size of the company, the recall team can be made up of one or several employees. If several employees are part of the recall team, the team should include members from different areas with a broad level of expertise. It is important to include the phone numbers of all the members and update their contact information on a regular basis. Each recall team member should have clearly defined roles and responsibilities, as it will help to ensure that the recall is completed correctly and in a timely manner. Some people can be assigned to multiple tasks, but their role should be defined in the recall plan. For example, facility managers and production personnel must gather production data to determine the cause of the failure in the process, collect manufacturing and shipping records, secure inventory, and design a process to handle the recalled product. Although the method of identification may vary depending on the animal food being recalled, the sales group must notify customers and collect lot numbers of the product, contact farmers to shut-off bins, and determine if animals need to be placed on a market hold or stop sale. The nutrition and quality assurance group must obtain samples at the facility and in the field, coordinate laboratory analysis, determine potential rework or disposal based on the results of the analysis, and contact the company veterinarian to get advice regarding health and residue potential if category II medications are involved in the recall. The communications group must develop press releases, set up a customer’s hotline if necessary, refer the customers to the correct technical group, and communicate with top management about all the aspects of the recall. While press releases can’t be established until the recall occurs, the recall plan can include templates to describe the information and where the press release needs to be sent. The communications team can also notify the regulatory agencies and the state recall coordinator as necessary. At the end of the recall process, the effectiveness of the recall must be evaluated by reconciling the number of bags or tons recovered compared to the total quantity recalled. To ensure that the recall process is working as intended and to identify and correct any problems ahead of time, mock recalls should be conducted on an annual or semiannual basis. Mock recalls should be designed to assist the recall team in practicing the implementation of the recall from incident identification to process conclusion. Keep in mind that a mock recall should also involve all members of the team, including alternate contacts on a regular basis. Mock recalls could involve the identification of one finished item and being able to trace the batch or lot number through the production process, while also identifying the ingredients that were used in its production. Similarly, a mock recall could involve the identification of a particular ingredient and being able to identify all the finished feeds in which it may have been included. Having a good traceability program to trace ingredients and products one-step forward and one-step back in the supply chain is important to make the recall more effective. This means creating and maintaining records of production and distribution at the facility. However, mock recalls are more than just a traceability exercise; in order to implement an effective recall program, the mock recall should engage a broader range of internal and external stakeholders in order to practice the whole recall process. Remember that Current Good Manufacturing Practices (CGMPs), sampling and monitoring the quality and safety of the incoming ingredients, and good quality control and traceability of your ingredients and finished products can prevent recalls or reduce the overall scope should one need to be implemented.
References Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals; Final Rule. Recall Plan. Code of Federal Regulations title 21, section 507.38, 2015.
Code of Federal Regulations. Title 21, Part 7, Subpart C: Recalls (Including Product Corrections) – Guidance on Policy, Procedures, and Industry Responsibilities. Available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-7/subpart-C?toc=1, accessed March 24th, 2022.
U.S. Food & Drug Administration. 2019. Investigations and operations manual, Chapter 7: Recall activities. Available at: https://www.fda.gov/media/75263/download, accessed March 24th, 2022.
U.S. Food & Drug Administration. 2018. Questions and Answers Regarding Mandatory Food Recalls: Guidance for Industry and FDA Staff. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-and-fda-staff-questions-and-answers-regarding-mandatory-food-recalls, accessed March 24th, 2022.
U.S. Food & Drug Administration. 2022. Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C: Guidance for Industry and FDA Staff. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/initiation-voluntary-recalls-under-21-cfr-part-7-subpart-c, accessed March 24th, 2022.