Food Safety Modernization Act (FSMA)

The FDA Food Safety Modernization Act (FSMA), the most sweeping reform of our food, animal feed, and pet food laws in more than 70 years, was signed into law by President Obama on January 4, 2011. The Act aims to ensure the U.S. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it. 

The U.S. Food and Drug Administration (FDA) published its final regulations mandated by FSMA to establish requirements for CGMPs; hazard analysis and risk-based preventive controls; and supply chain management programs for human food, animal feed, and pet food on September 17, 2015. 

These regulations apply to domestic and foreign facilities that manufacture, process, pack or hold (store) animal feed and/or pet food, and ingredients used in such products. In general, the requirements apply to facilities that are required to register with the FDA under the agency's existing facility registration regulations implemented as part of the Bioterrorism Act.  More Info - Biennial Registration Food Facility

In November 2015, FDA released the agency's final rules mandated by FSMA for produce safety, foreign supplier verification programs (FSVP), and accreditation of third-party certification bodies/auditors. FDA's final rules for FSVP and accreditation of third-party certification cover a wide variety of entities involved with importing food, including importers of raw agricultural commodities, such as grains and oilseeds, animal feed, feed ingredients, human food, and food ingredients. 

Food Safety Modernization Act Dashboard

The FDA has finalized seven major rules to implement FSMA, recognizing that ensuring the safety of both the human and animal food supply is a shared responsibility among many different parties at various points in the global supply chain. The FSMA rules outline specific actions the food industry must take at each of these points to prevent contamination. For each rule, the FDA has identified measures that will help to evaluate how well the rules are being implemented and where there could be room for improvement.  
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Deadlines Set for FDA to Establish Reporting Requirements for “High-Risk” Foods (June 2019)

As part of the FSMA regulations, FDA was to (1) designate high-risk foods for which additional recordkeeping requirements are appropriate and necessary to protect the public health; and (2) publish a notice of proposed rulemaking to establish recordkeeping requirements for facilities that manufacture, process, pack, or hold such foods. The FSMA also required FDA to publish the list of foods designated as high-risk on FDA’s website at the time the Agency promulgates the final rule establishing recordkeeping requirements.
  • Sept. 8, 2020 – Deadline for FDA to designate the list of “high risk” foods as required by the FSMA Section 204(d)(2)(A).
  • Sept. 8, 2020 – Deadline for FDA to publish a proposed rule, including record-keeping requirements for high-risk foods, also as required by FSMA Section 204(d)(2)(A).
  • Nov.7, 2022 – Deadline for FDA to issue a final rule, including record-keeping requirements for high-risk foods, also as required by FSMA Section 204(d)(2)(A).
In February 2014, FDA previously put out a Draft Approach for Designating High-Risk Foods, which outlined several criteria for designating a food as high-risk: (1) outbreak frequency and illness occurrence, (2) severity of illness, (3) likelihood of microbial or chemical contamination, (4) microbial growth potential/shelf life, (5) the probability of contamination and steps taken during manufacturing to reduce contamination, (6) food consumption patterns, and (7) economic impact. Whether the Agency will utilize its draft approach to develop its list of “high risk” foods remains to be seen.

Link to FSMA Website


Current Good Manufacturing Practices (CGMPs)

  1. Personnel
  2. Plant and Grounds
  3. Sanitary Operations
  4. Sanitary Facilities and Controls
  5. Equipment and Utensils
  6. Processes and Controls
  7. Warehousing and Distribution

Hazard Analysis Risk-Based Preventive Control (HARBPC)

  1. Food Safety Plan
    1. Must be implemented by "qualified" individual.
    2. Must be readily available on-site and site-specific.
    3. Retain records for a minimum of 2 years.
  2. Hazard Analysis
  3. Preventive Controls
  4. Recall Plan
  5. Monitoring
  6. Corrective Action
  7. Verification
    1. Reanalysis of the plan must be conducted every three years, when significant changes are made at the facility, whenever new hazards are identified, when preventive controls are found to be ineffective or not properly implemented.
In 2014, FDA estimated the annual cost of compliance for an "average" facility to be around $14,700 to $20,100 per facility. At this time, the grain and feed industry estimated the annual cost per facility to be at least $65,000 per facility.