全方位服务的食品安全导航

The ever-changing face of food safety and regulation has has prompted Leavitt Partners, Faegre & Benson and B&D Consulting to join forces in providing companies involved in the global food supply chain with a collaborative solution to food safety management. This joint effort offers guidance to companies seeking to navigate the shifting food safety challenges of today’s systems, and the new regulations resulting from the passage of the 2011 Food and Drug Administration Food Safety Modernization Act (FSMA).

这三个合作伙伴为饲料和谷物杂志描述他们将如何帮助公司有效管理风险并应对食品安全领域的挑战。与共同客户合作时，这三个组织将共同运营，通过这种协同作用，能够提供一套独特而强大的解决方案，以涵盖潜在的食品安全问题的各个方面。

想象一下这种情况：猪链中的饲料添加剂具有一些污染物/掺假剂，可能会影响最终的肉类产品，并且可能已进入消费者供应链。

Faegre & Benson: A Legal Perspective

潜在的ly contaminated or adulterated animal feed fed to swine can have varying legal implications ranging from customer management and regulatory compliance to complex litigation. Experienced legal counseling and representation is critical given the broad and varied implications of food safety issues, including regulatory enforcement and private litigation.

As soon as the client is aware of the feed additive that may have been contaminated or adulterated, Faegre & Benson works with that client to create a response plan and engage in risk management. Faegre & Benson is prepared to advise the client on supply chain management issues, counseling and reporting requirements, recall plans, avoiding or preparing for potential FDA enforcement actions, handling commercial claims and litigation arising from food contamination, addressing recall labeling issues, and advising on food labeling and recordkeeping requirements. Particularly important in this scenario, Faegre & Benson will assist in navigating the complex jurisdictional and regulatory issues that arise when both US Food and Drug Administration (FDA) (which regulates feed) and the United States Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) (which regulates meat) are involved in a food safety issue.

第一步是与客户合作，充分了解围绕潜在污染的背景和事实，以估计所涉及的法律含义的广度。从那里，Faegre＆Benson具有相关法定计划和代理指导声明的经验，以及其在为客户处理这些危机方面的深刻经验，将有助于客户了解与监管机构打交道时可能面临的问题。此评估对于协助客户确定下一步将采取哪些步骤至关重要。

下一步将是审查即时所需的行动；例如，是否有对FDA的报告要求，例如可报告的食品注册表。Faegre＆Benson还将帮助客户评估召回的可能性 - 知道是否需要召回，如果是的，则指导客户完成召回程序的每个步骤。这包括在此过程中采取必要步骤的咨询，以最大程度地减少对商业和消费者索赔的接触，与代理商合作谈判成本最低的行动，并帮助获得保险（如果有）。

Faegre & Benson also assists in appropriate communication of the legal issues with customers of the potentially adulterated product. This is critical in managing downstream risk. If other litigation arises, such as food-borne illness litigation, consumer lawsuits, or other commercial claims, Faegre & Benson is able to handle each step through the litigation process.

After the situation is under control and all regulatory and safety concerns have been handled to the greatest extent possible, Faegre & Benson 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＆Benson将在任何食品安全问题的每个步骤中为客户提供有关法律和监管问题的建议，并在与Leavitt Partners和B＆D Consulting的团队成员合适时紧密合作。整体方法可以最大化整体风险管理，以最大程度地减少成本和对公司的破坏。

Leavitt Partners: 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.

管理急性危机情况需要组合技能组合，包括了解人类和动物的真正风险，根据这些风险和监管要求做出正确的公司决策，随着过程的展开，与监管机构进行互动，以及向客户和客户的行为传达一般公众。

Leavitt Partners通过快速分析奸淫背后的科学及其如何影响人类健康的科学，具有评估公共卫生风险的专业知识和经验与人类疾病和死亡有关的品牌损害。这使客户可以就下一步做出明智的决定。如果已经有人类疾病已导致客户的产品，Leavitt Partners有能力迅速审查将人类疾病与客户的产品联系起来的流行病学，以确定协会的实力。随着这种情况的发展，我们与联邦和州调查人员的关系可以利用。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.

如果需要发行有关危机的新闻或媒体沟通，Leavitt Partners在开发准确，适当的公共卫生信息方面具有丰富的经验，可以帮助公司通过书面新闻报表，相机访谈或通过其他手段。

历史表明，一旦一家公司遭受危机袭击，其未来就会采取两条途径之一：它遭受了无法弥补的损害，经常倒闭，或者它利用这种情况向客户和公众证明了从经验中学到的东西并且，通过沟通和行动，将自己定位为行业领导者。一旦危机在客户后面，就很容易忘记潜在的课程。但是，我们的经验告诉我们，这些是检查可能导致危机可能导致危机可能发生的风险的绝佳机会。即使在危机情况下，也应解决这一问题，在危机情况下，将新的预防策略确定并传达给客户，以确保客户解决未来的任何风险。Leavitt合作伙伴将在这种情况下与客户合作，以​​检查上游供应链风险以及如何控制它。这可能需要更改所需规范，分析证书或供应商审核的方法。它可能涉及产品跟踪和批次控制的变化，或者可以使用HACCP原则和有针对性的先决条件程序来重点进行内部处理。在采样计划，使用认可的实验室或测试策略方面，可能需要对产品测试进行重新评估。无论基本原因，诸如此类的情况都可以并且应该与客户一起利用，以关注“我需要做些什么以防止这种情况再次发生”的关键问题。 Leavitt Partners has the skills to guide the client through this process.

B＆D咨询：处理联邦事务，联盟建设

The crisis will trigger (in a well-run federal agency and department) establishment of a government crisis-response team whose actions will directly impact the company. Agency subject matter experts and political leaders may literally gather in a war room-like setting and by teleconference to gather situation-status information, identify problems and solutions, and impose their view of the best federal response.

这场危机也可能引发高度政治活动，因为国会的各个成员可以通过捍卫他们代表的当地公司或利用这种情况来煽动煽动者，寻求媒体关注，呼吁听证会和推动政策改革来利用这种情况。。

公司必须制定政府事务和公共交流策略，该战略纳入了食品安全法，政策和法规的广泛知识，以最大程度地提高沟通和对公司自身反应的信心，最大程度地减少公司的妖魔化，建设性地利用政府支持，并进行政府的支持以及从长远来看，保护公司收入。

clo工作sely with our partners in this collaboration, B&D Consulting would immediately take some of the following steps:

• 与USDA，HHS和FDA政治领导（以及白宫（如果这是严重的国家级危机））合作，以使他们了解发展并确保开放的沟通方式，确保公司可以避免与政治动机有关的惊喜报复。经营良好的代理机构将利用公司的其他信息，这是如果媒体激起狂野的场景，使凉爽的头部盛行。

• 与公司的代表/参议员合作，以确保他们拥有完整的信息，并有助于支持公司的回应。

• 与对农业和FDA问题具有管辖权的国会委员会合作，以使他们类似地了解发展，并立即赶紧赶往新的立法解决方案。委员会还将考虑建立“监督和调查”询问，其中涉及文件或公司管理层的传票，以进行国会简报或公开听证会。与委员会进行过度反应的早期参与至关重要。如果实际上举行了听证会，该公司将需要额外的帮助来起草书面证词并准备证人回答记录中的问题。

• 与公司的政府事务和沟通团队合作，以确保向所有受众（包括媒体，公众一般，社交媒体）的公共通信/消息传递与政府消息一致。

It is essential that the company establish a federal affairs crisis response that is rooted in a deep knowledge of the food safety-related issues at hand, that understands the agency's own crisis team and the other federal actors’ response in such a situation, and that delivers timely information, credibility, and results.

—杰基·罗姆克（Jackie Roembke）