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FDA Discusses Key FSMA Implementation Principles

On October 20, 2015, the U.S. Food and Drug Administration (FDA) hosted a public meeting regarding the agency’s implementation strategy for the Food Safety Modernization Act (FSMA). During the meeting, FDA discussed a number of key implementation principles:

Regulator Training

FDA said that regulator training will promote uniform, quality inspections and consistent decision making.  Regulator training will cover technical knowledge, inspection skills, and behavior and systems thinking.  FDA will offer training through a variety of channels, including:

  • Industry best practices webinars
  • Alliance courses with industry
  • Support and mentoring through FDA’s Technical Assistance Network

FDA also plans to host “FSMA Chats,” monthly broadcasts to FDA and State food and feed safety staff to keep them updated on what’s going on with FSMA.


FDA wants to steer away from their current “one size fits all” approach to facility inspections. “What works for a large firm may not work for a small firm,” FDA said.  Planned changes to FDA’s inspection process include:

  • Switching from observation-focused facility inspections to system-based inspections
  • Offering more interactive, cooperative inspections
  • Consideration of a facility’s food safety and management systems
  • Utilizing more data and sample collection activities
  • Recognizing firms for finding and fixing problems and displaying continuous improvement

Compliance and Enforcement

FDA plans to offer incentives to encourage industry to comply and make corrections on their own.  For example, FDA said facilities with a good compliance history will likely undergo shorter and fewer inspections.  FDA also plans to alter its enforcement of violations based on risk. The agency said it wants to recognize that not all observations on a 483 (the form FDA uses to identify inspection violations) are equal.  FDA plans to create a ranking system (critical, major, minor) based on the public health risk of various violations. The different ranks would affect factors such as the timeline FDA offers for corrective action.

For more information on FDA’s FSMA implementation strategy, read our blog about another FDA public meeting hosted earlier this year.

FDA published finalized versions of its Preventive Controls Rules for Human and Animal Food in September 2015. These are the first of the seven major FSMA rules to be finalized.  FDA said it intends to implement training for Preventive Controls for Human Food in Spring 2016 and for Animal Food in Summer 2016.  Three additional major FSMA rules (FSVP, Produce Safety, and Accreditation of Third-Party Auditors) are expected to be finalized by October 31, 2015.

Registrar Corp stays up-to-date on U.S. FDA regulations and will continue to update industry as FDA’s implementation of FSMA progresses.  If you have questions regarding upcoming regulations under FSMA or other U.S. FDA regulations for marketing food and beverages in the United States, contact Registrar Corp at +1-757-224-0177. Live help is available 24-hours a day at www.registrarcorp.com/livehelp.