During this two-part session, GMA Science Forum attendees heard from a panel consisting of Michael Robach, Vice President, Corporate Food Safety and Regulatory Affairs, Cargill, Inc.; Camille Brewer, Director, International Affairs, U.S. Food and Drug Administration; Joseph A. Levitt, Partner, Hogan & Lovells US, LLP; Bradd P. Eldridge, Director, Quality Assurance, Abbott Nutrition; and Robert Guenther, Senior Vice President, Public Policy, United Fresh Produce Association.
Robach explained how across today’s consumer packaged goods landscape, emerging countries are joining the global food supply chain, presenting a unique regulatory challenge to bring those countries up to acceptable food safety standards. Some of the major supply chain challenges at the global level include danger of protectionism, food security challenges, increased global conflict and tension, government intervention, global recession and financial markets disruption.
Robach also stressed that global consumption directly impacts the complexity of food security. Food security exists when everyone has access to safe, nutritious, affordable food, which is the foundation for an active and healthy life. As the world’s population growth skyrockets, food security becomes a top priority. By 2050, the world population is expected to reach 9 billion, which places a strain on food production and requires that industry finds ways to double the amount of food production around the world. The need to double or triple the food supply with limited farmland and natural resources means that “industry innovation and technology may often have to take a back seat to simply maintaining food production levels,” said Robach.
Camille Brewer expanded on this topic by discussing what exactly the FDA is doing to address these challenges. The predominant focus of her segment was the paradigm shift taking place at the FDA from an “inspect everything, get the bad guys” approach to increased partnership development and regulatory changes that will yield added safety and security for American consumers. The Global Product Pathway Report, developed by an internal committee of experts that analyzed trends and data to bring about an action plan to move the FDA into the future, lays the road map for this shift.
“We can’t just be the police and just enforce at the border. We have to create the architecture to address the challenges of globalization,” said Brewer. One of the key strategies brought about by the report, she explained, is the notion of developing coalitions, such as the APEC/Partnership Training Institute Network, the Food and Agriculture Organization, and the World Health Organization partnership. In addition to expanding partnership involvement, the FDA is also hitting the ground running with the Food Safety Modernization Act (FSMA), by communicating its vision and statutes in a variety of formats. Already the FDA has conducted over 400 listening sessions and presentations to a broad group of stakeholders and is executing additional pre-proposal outreach, including embassy briefings, public meetings, information sessions and farm visits.
Joseph Levitt of Hogan Lovells discussed five key concepts from the U.S. regulatory perspective: preventative controls as baseline requirements; supplier verification by US manufacturers and importers; leveraging foreign governments; special tools for bad actors; fast lane for good actors. Prevention is the cornerstone of FSMA, and all companies are subject to the same requirements. Supplier verification allows for some aspect of control on the manufacturers’ side, as they can pick and choose among those suppliers who have certification and those who don’t. Third-party certification programs also eliminate suppliers from having to be repeatedly audited; instead they can just show their certification.
By leveraging foreign governments, Levitt argued, we can “move the border” across the ocean and allow FDA foreign offices to play a key facilitative role. Special tools for bad actors include intervention by accredited auditors, mandatory certification, lab testing, and other extra measures that should be used sparingly when the FDA makes a finding that a foreign food safety system is inadequate or not as safe as food in the U.S. The bottom line, Levitt says, is that “consumers want the same level of confidence about their food products, regardless of the source”. The international program parallels domestic programs, but the main difference is assuring compliance. The FDA must leverage foreign governments to take advantage of third-party certifications.
In the second part of the session Levitt presented on the two new rules of FSMA, boiling it all down to several key takeaway messages. First, the proposed rule generally tracks the statute that registered facilities must have a food safety plan and make records available to the FDA, with limited exceptions granted. Second, the FDA has tried to align this proposal with HACCP, and uses the same principles and technology. Supplier verification is not yet required, although it is expressly identified as a preventative control; FDA has not proposed to mandate supplier verification and approval activities, likely due to cost.
Testing is also not yet required, but a food safety system must be in place, so there is some elevation of expectations. There is also a heightened emphasis on validation and corrective actions in the proposal.
Another large component of the proposal is the emphasis on recordkeeping and FDA access, as well as new record creation requirements, such as always keeping the food safety plan on site. Small businesses are allowed extra time for compliance, as well as modified requirements. Large businesses have one year to reach compliance, while small businesses have two years and very small businesses have three years.
Bradd Eldridge of Abbott Nutrition addressed the major differences between old and new food safety legislation. FSMA is more process and prevention oriented than the old law; it is also proactive, global and has more focus on risk assessment and improved communication. Eldridge emphasized that the significant changes occurring as a result of FSMA will make industry a partner in safeguarding the health of US consumers.
Panelist Robert Gunther spoke specifically about the impact of the Produce Rule, which establishes science-based standards for the safe production and harvesting of produce and is the most significant revision to food safety legislation in the U.S. since 1938.