Food Safety Experts Collaborate to Offer Integrated Approach to Regulatory Compliance

Washington: Leavitt Partners, Faegre & Benson LLP and B&D Consulting are joining forces to provide companies involved in the global food supply chain with a collaborative solution to food safety management. This joint effort will provide guidance for companies seeking to navigate the shifting food safety challenges of today's systems and those required to comply with new regulations resulting from the passage of the 2011 Food and Drug Administration Food Safety Modernization Act (FSMA).

FSMA aims to create a prevention-based 21st century food safety system and grants FDA additional regulatory authority concerning food. This food safety solutions group will integrate technical, regulatory, legal, federal affairs, management consulting and coalition-building services to assist businesses in navigating and complying with a complex set of new rules and regulations. Using an integrated approach, this partnership allows clients to address their food safety management needs holistically by working with a diverse group of experienced food safety professionals. Companies can take advantage of all or a subset of the collaboration's services based on their individual needs.

"By integrating all the expertise in this collaboration, we are able to deliver unique, cross discipline counsel on critical food safety issues," states Kim Walker, head of the food and agriculture industry focus at Faegre & Benson.

The three collaborating organizations are uniquely positioned to advise food industry stakeholders on safety issues. Founded and chaired by Michael O. Leavitt, former secretary of health and human services, Leavitt Partners is a technical, scientific and regulatory advisory group operating in the health care and food safety sectors. The organization provides assessment services to determine the gap between a company's capabilities and FSMA requirements, support and guidance in writing food plans required under FSMA, expert advice on preparing for a crisis and handling recalls, and real-time updates on food safety issues from regulatory bodies.

"The need to integrate food safety with food quality and new compliance requirements in an environment of budgetary constraint requires broad risk-based thinking and priority setting, and I believe this collaboration will provide that to the food sector," Michael O. Leavitt says.

Faegre & Benson is an international law firm with approximately 450 lawyers and locations in Minneapolis, Denver, Boulder, Des Moines, London and Shanghai. The firm represents many of the world's leading food companies on a wide variety of legal issues. Legal services include advising clients on supply chain management issues; counseling on reporting, recall plans and potential FDA enforcement actions; handling litigation regarding potential claims arising from food contamination, recall or labeling issues; advising on food labeling and recordkeeping requirements; and assisting with risk management. The firm's food, agriculture and biofuels industry focus dates back to 1912 and includes nearly 120 lawyers.

B&D Consulting is a national advisory and advocacy firm based in Washington, D.C., whose advisors have significant federal agency and congressional expertise and have served as lead drafters and negotiators for FSMA and other FDA reform bills. The firm provides federal affairs and coalition-building services such as influencing, monitoring and responding to agency and congressional activity related to food safety; organizing a multi-stakeholder food safety coalition to affect the development of related policies and regulations; building public-private research partnerships to develop food safety technologies; consulting with senior executives on structural and resource allocation for FSMA-mandated services; and providing information on key FDA, congressional and stakeholder activity.

"The leaders of this collaboration directly shaped the FSMA legislation and U.S. food safety policies and have advised the world's leading food companies on legal and technical matters," says Vince Ventimiglia, senior vice president of B&D Consulting's health and life sciences team and former assistant secretary of legislation for the Department of Health and Human Services. "These three organizations are fully equipped to help food companies or stakeholder coalitions develop comprehensive solutions in this changing regulatory environment."

The collaboration has become operational as of Oct. 26, 2011, and is prepared to advise companies in the food industry on FSMA requirements and compliance.

In January 2012, Faegre & Benson will combine with the law firm Baker & Daniels LLP to form a new firm of approximately 770 lawyers and 45 consultants, Faegre Baker Daniels. B&D Consulting is a division of Baker & Daniels and will become FaegreBD Consulting when the firms combine. The food safety solutions group will continue to operate under this new arrangement.