After the situation is under control and all regulatory and safety concerns have been handled to the greatest extent possible, Faegre Baker Daniels is available to assist the client in further developing its recall and crisis response documents and in devising solutions to assure the problem never happens again. This may include reviewing a HACCP plan or creating a more comprehensive hazard analysis plan required under FSMA, perhaps with more detailed preventive controls and hazard-based analysis.
Faegre Baker Daniels will be there for the client through each step of any food safety issue to advise on legal and regulatory issues, working closely when appropriate with team members from Leavitt Partners and FaegreBD Consulting. The holistic approach maximizes the overall risk management to minimize costs and disruption to the company.
Technical, scientific and regulatory services
Contaminated animal feed fed to swine can have multiple veterinary and human health implications. It also represents the challenge of navigating a regulatory situation that bridges both the U.S. Food and Drug Administration and the Department of Agriculture’s Food Safety and Inspection Service. As such a situation evolves, there are two significant angles that have to be addressed. The first is managing the immediate crisis, and the second is finding ways to ensure that appropriate preventive controls are put in place to minimize the likelihood of a recurrence.
Managing the acute crisis situation requires a combination of skill sets that include understanding the real risk to humans and animals, making the right company decisions based on those risks and regulatory requirements, interacting with regulators as the process unfolds, and communicating company actions to customers and the public in general.
Leavitt Partners has expertise and experience in assessing public health risk by quickly analyzing the science behind the adulterant and how it can impact human health, and then presenting that information to our client in a way that is easily understood in the context of regulatory impact and potential brand damage linked to human illness and deaths. This allows the client to make informed decisions regarding next steps. Should there already be human illness that has led back to the client’s product, Leavitt Partners has the capacity to rapidly review the epidemiology linking the human illness with the client’s product to determine the strength of the association. Our relationships with federal and state investigators can be leveraged as this unfolds. Leavitt Partners’ personnel have held senior positions at both the FDA and FSIS and thus know how the agencies operate and think, and in this capacity can interact directly with the regulators along with the company to address the ongoing crisis as well as potential regulatory and enforcement actions.
Should the need arise to issue press or media communication concerning the crisis, Leavitt Partners has substantial experience in developing accurate, appropriate public health messages and can help the company communicate with the media, either via written press statements, on-camera interviews, or by other means.
History shows that once a firm is hit with a crisis, its future takes one of two paths: It suffers irreparable damage and often goes out of business, or it uses the situation to demonstrate to customers and the public that it has learned from the experience and, through communication and action, positions itself as an industry leader. Once the crisis is behind the client, it is easy to try to forget potential lessons; however, our experience has taught us that these are the perfect opportunities to examine risks that may have contributed to the likelihood of the crisis occurring in the first place. This should be addressed even during the crisis situation in which new preventive strategies are identified and communicated to customers to ensure them that the client is addressing any future risks. Leavitt Partners would work with the client in this situation to examine upstream supply chain risk and how to control it. This may require a change in approach to required specifications, certificates of analysis or supplier audits. It may involve changes in product tracking and lot control, or it may focus on internal processing using both HACCP principles and targeted prerequisite programs. It may require a reassessment of product testing as regards sampling plans, use of accredited laboratories or testing strategies. Whatever the underlying cause, situations such as these can and should be leveraged with a client to focus on the key question of “what do I need to do differently to prevent this from happening again.” Leavitt Partners has the skills to guide the client through this process.