The FDA Invites Comments from Food Processors on Proposed New FSMA Rules

The U.S. Food and Drug Administration (FDA) recently released a new strategy document that outlines the agency’s guiding principles for implementing the Food Safety Modernization Act (FSMA). This latest move by the FDA is designed to encourage dialogue and collaboration between the agency and the food industry as FSMA moves into its next phase – the effective and efficient implementation of the new standards.

According to the FDA’s Deputy Commissioner, “this is where the rubber meets the road.” The FDA is seeking comments from the food processing industry on the initiatives outlined in this strategy document before the final FSMA rules are released in late 2015 and early 2016.

The strategy document includes programs to provide greater support to food processors and help them achieve high rates of compliance with FSMA. It also includes a number of internal initiatives for the FDA to improve its outreach and response to food safety incidents. Highlights of the new strategy include:

  • Advancing public health — Reducing the risk of foodborne illness through modern preventive practices and ensuring that food processing facilities are effectively implementing prevention controls is at the core of FSMA.
  • Leveraging and collaborating — The FDA will leverage its relationships with outside partners in the food safety industry including international organizations, the food industry, growers, academic experts, and consumers. This component also includes data integration, analysis, and information sharing among partners.
  • Strategic and risk-based industry oversight — Food processors will be equipped with a tool kit, developed by the FDA, that includes education to ensure expectations and requirements are understood, along with technical assistance to facilitate compliance. Additional tools include regulatory incentives for compliance such as less frequent inspections and reliable third-party audits to verify compliance.
  • Planning — Internal performance metrics will be established for the FDA, which will be aligned with the FSMA’s mission of prevention, emphasizing the need for seamless data sharing and collaborative data analysis. 
  • Execution — The FDA plans to provide food processors with access to subject matter experts before, during and after inspections. These streamlined processes will enable more timely decisions and resolutions regarding corrective actions, enforcement, and other measures to achieve public health and consumer protection.
  • Evaluation  The establishment of program-wide, public health-oriented outcome metrics with systematic collection will benefit the entire industry.

Food industry representatives are encouraged to review the strategy document and provide comment on these issues that will drive new rules. The FDA offers easy online access to provide comment on this strategy document via this link on their website.


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