PRODUCT RECALLS BY MARC E. SORINI
ood safety situations and the closelyrelated question of whether to conduct a recall rank among the most stressful that a distillery decision-maker can face. The safety of your consumers, your short-term sales and the long-term reputation of your distillery and brand hang in the balance. Things move fast and decisions must be made with less-than-perfect information. No preparation will render such situations easy or routine. A distiller can, however, reduce the stress level and help navigate this “worst-case” scenario by understanding the process and taking certain steps to prepare. Of course, careful quality control and good manufacturing practice protocols are every company’s best defense against a potential product safety problem. However, even the best companies cannot prevent every potential hazard, many of which may arise from circumstances (e.g., the purchase of defective bottles) entirely outside the distiller’s control. This outline aims to familiarize you with the recall processes and situations while suggesting areas where preparation can help.
KNOW YOUR TEAM Reacting swiftly and properly to a potential food hazard requires expertise from a number of disciplines.
Operations (production and supply) personnel usually are in the best position to identify the potential source and root cause of any issue.
Personnel responsible for sales and distribution are needed to identify affected product and, if necessary, organize a recall of product in the market.
Marc E. Sorini is a partner in the law firm of McDermott Will & Emery LLP, based in the Firm’s Washington D.C. office. He leads the Firm’s Alcohol Regulatory & Distribution Group, where he concentrates his practice on regulatory and litigation issues faced by supplier-tier industry members. His practice for distillers includes distribution agreements, distribution counseling and litigation, product formulation, labeling, promotional compliance, compliance strategy, and federal and state tax and trade practice enforcement defense.
• Communications skills may be needed to ensure that a recall notice reaches its intended audiences swiftly and accurately. •
Legal counsel with product recall experience is needed to advise on the process, legally-required filings, and to handle communications with relevant government bodies. Moreover, involving counsel can help provide certain sensitive communications and studies with the confidentiality protection of the attorney-client privilege and/or attorney work product doctrine. Companies also need expert assistance in identifying and understanding the nature of the risks arising from a given hazard situation. A number of consulting groups with substantial food safety credentials are available to help, and should be retained through counsel to at least partially protect the confidentiality of their work under the attorney work-product doctrine. Finally, but perhaps most importantly, decisions on responding to a potential product safety issue can profoundly impact the future of a company. For this reason, the decision-making circle generally must involve people with the authority to make important decisions. A distiller can help prepare for worstcase scenarios by identifying the members of its team (both internal and external) before a crisis arises. Moreover, holding occasional “drills” with this group will help regularize and organize the crises response team, allowing for a smoother response when an actual issue arises.
GATHERING FACTS TO “BOUND” THE SITUATION When a situation arises, a company must move quickly to protect the public and its
own reputation. At its most general, this starts with gathering relevant information as quickly as possible and being ready to act on the basis of often-incomplete or imperfect information. While every situation is different, a number of facts form the core of what a decision maker needs to know. At the outset, it is important to note that not every reported safety issue is created equal. In my experience virtually every company above a reasonable size experiences a certain amount of “background noise” that theoretically could represent a safety problem. For example, the occasional phone call complaining of feeling bad the day after consumption or chipped bottles may not be cause for particular alarm if protocols are strong, the report remains unsubstantiated (e.g., a supposedly defective bottle is never provided), and the frequency of such reports remains at a low level. But distillers must carefully evaluate communications from consumers so they can separate the reports requiring serious consideration from the “background noise” of day-to-day consumer communications. Where a potentially serious situation DISTILLERS arises (and when in MUST CAREFULLY doubt, EVALUATE treat COMMUNICATIONS FROM a
CONSUMERS SO THEY CAN SEPARATE THE REPORTS REQUIRING SERIOUS CONSIDERATION FROM THE “BACKGROUND NOISE” OF DAY-TO-DAY CONSUMER COMMUNICATIONS. 33
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