Newses & Articles

FDA Releases Landmark Rule under FSMA: What You Need to Know
Publish Date : 1395/5/20 Time 10:25:47



FDA Releases Landmark Rule under FSMA: What You Need to Know

By John H. Cox
Executive Director, FEMA

The U.S. Food and Drug Administration (FDA) recently released two new proposed rules under the Food Safety Modernization Act (FSMA), shifting its focus toward a proactive, rather than reactive, food safety monitoring programs. The two regulations, Preventive Controls for Human Food and Standards for Produce Safety, address current gaps in food production and manufacturing processes.

Together with the American Spice Trade Association (ASTA), the Flavor and Extract Manufacturers Association (FEMA) recently held a webinar wherein food safety experts Joe Levitt and Maile Gradison Hermida of Hogan Lovells took an in-depth look at the 680-page rule requiring food manufacturers to prepare and implement a written food safety plan.

During the webinar, Levitt and Hermida highlighted a number of specific questions, ranging from what organizations need to know about this landmark rule to the potential impact on their company’s business operations. The essential provisions that members would have to employ include the following:

  • Hazard analysis: Evaluate reasonably foreseeable hazards for each type of food manufactured, processed, packed or held at a facility.
  • Preventive controls: Assure that hazards can be significantly minimized and prevented through process, food allergen, and sanitation controls and a recall plan.
  • Monitoring: Provide up-to-date records on the performance of preventive controls.
  • Corrective actions: Take action if problems reoccur at facilities to prevent affected food from entering commerce. 
  • Verification: Validate that preventive controls are consistently effective.
  • Record keeping: Keep a written food safety plan that includes documentation of hazard analysis, monitoring, corrective actions and verification.

Over the next 120 days, FDA will be accepting public comments on the proposed rule and make adjustments based on the feedback received at the end of the period. Additionally, the public is welcome to attend upcoming meetings scheduled to take place in Washington, D.C., Portland, Ore. and Chicago, Ill to debate the FDA’s new rules.

FSMA recognizes the need for a global approach to food safety and aims to ensure the safety of the U.S. food supply. Across the board, companies should expect several years before full implementation. Nonetheless, it is imperative that FEMA and ASTA member companies strongly grasp these requirements right away. The rule applies to all facilities that manufacture, process, pack, or hold human food, and it’s never too early to begin planning and preparation.

What do you think of FDA’s new rule covering hazard analysis and preventive controls? Do you think the benefits will outweigh the costs of implementation? We welcome your comments below.

The Flavor and Extract Manufacturers Association of the United States (FEMA) was founded in 1909 and is the national association of the U.S. flavor industry.  FEMA’s membership is comprised of flavor manufacturers, flavor users, flavor ingredient suppliers, and others with an interest in the U.S. flavor industry.  The association is committed to ensuring a safe supply of flavor ingredients used in foods and beverages enjoyed by billions of men, women, and children around the world.