FDA focuses on FSMA Phase 2 implementation

The Food and Drug Administration (FDA) focused on implementation of Phase 2 of the Food Safety Modernization Act (FSMA) at its public meeting in Chicago on October 20.
According to Roberta Wagner, associate director for FSMA operations, Center for Food Safety and Applied Nutrition at the FDA, FSMA is being implemented in three phases:

• Phase 1: Setting standards by developing regulations and policy.
• Phase 2: Designing strategies to promote and oversee industry compliance by identifying performance metrics to measure success.
• Phase 3: Transitioning strategies and performance metrics from design to operation and evaluating their success.

To implement Phase 2, which is the next step in the process, FSMA workgroups were established by the FDA’s food and veterinary medicine executive council. Those workgroups are charged with developing the framework and multi-year implementation plan for ensuring compliance.
“We’ve set ourselves up so we are not operating in silos within the agency,” Wagner said.
Guiding Phase 2 FSMA implementation is a Program Alignment Initiative that relies on several factors to result in successful FSMA implementation:

• Vertically integrated, commodity-based programs
• Specialization of inspection and compliance staff and regulatory labs
• Clear, current and consistently applied policy
• Streamlined decision-making
• Risk-based allocation of program resources
• Agreed-upon performance and public health metrics

Key implementation principles

Joann Givens, food and feed program director for the FDA Office of Regulatory Affairs, explained that Phase 2 implementation relied on several key principles. Those are:

• Industry education, outreach and technical assistance: This can be achieved by facilitating industry compliance with prevention-oriented standards through guidance documents, tools and resources for education, alliances with stakeholders, and technical assistance networks.
• Regulator training: Stringent training will promote uniform, quality inspections, which will result in consistent decision-making by regulators.
• Inspections: Systems-based inspections, as opposed to observation-focused ones, will be interactive and cooperative.  
• Compliance and enforcement: The development and implementation of explicit inspection and enforcement strategies will facilitate consistent decision-making by regulators. The FDA also will encourage the industry to comply with regulations and make corrections on its own. The agency says it realizes that not all observations are equal relative to risk and the potential for public health impact and that it is aiming for a dynamic regulatory strategy.
• Accountability and stakeholder engagement: The FDA is looking to develop meaningful public health and performance metrics to measure the success of FSMA implementation. It says it recognizes the role of the marketplace in influencing and expanding industry compliance with FSMA rules and therefore plans to work closely with industry, government agencies, academia, other key stakeholders and partners.