FSMA Implementation: What to Expect from FDA in 2017

The BRC Food Safety Americas Conference welcomed Sharon Mayl, Senior Advisor for Policy of the U.S. Food and Drug Administration (FDA) who spoke on FDA’s progress regarding FSMA implementation.

As Mayl reviewed FDA’s two-phased approach to FSMA implementation, the focus of FDA’s in progress and future FSMA work quickly turned to Phase 2—developing strategies to promote and oversee industry compliance.

With a large degree of phase 1 (i.e., setting standards) completed through the issue of final rulemaking in 2015 and 2016, as well as a fair number of guidance documents for rule interpretation published in 2016, what can we expect from FDA in 2017 and beyond?

Currently, efforts are channeled on developing and delivering against a multi-year plan implementation plan to achieve industry compliance with regulations and reduce foodborne illness. How is FDA going to do this you ask; and what does this mean in terms of agency actions?

As FDA moves through this operational phase and along the implementation continuum, we can expect to see

• Additional guidance to support final rules
• Continued training from FDA recognized Alliances
• Increased Technical Assistance Network (TAN) support
• Inspector training, calibration and mentoring
• Dynamic inspection and enforcement strategy that embraces risk-based decision-making and encourages cooperation and self-correction
• Data collection and analysis against agency performance goals and metrics

With Preventive Controls for Human Food regulation already in effect for many manufacturers and more than a year of Preventive Controls training underway, FDA’s focus on guidance and education support those organizations regulated by the Sanitary Transportation, Foreign Supplier Verification Program (FSVP), Preventive Controls for Animal Food, and Produce Safety rules with fast-approaching compliance timelines.

To spur compliance, the industry can look forward to the publication of guidance documents to support the above-mentioned rules—including publication of Intentional Adulteration guidance—along with dedicated training from FDA Alliances who develop standardized curriculum and teach courses to help carryout FDA’s central tenet of education.

This includes the Food Safety Preventive Controls Alliance (FSPCA) responsible for overseeing training related to Preventive Controls and FSVP regulation, the Produce Safety Alliance (PSA) who provides training to primary producers for compliance with the Produce Safety rule and the Sprout Safety Alliance (SSA) providing specialized training to operations that grow, harvest, pack and hold sprouts for compliance with Produce Safety standards.

Providing further guidance is the Technical Assistance Network (TAN)—launched in 2015—with a two-fold objective of supporting the industry in regulatory interpretation and supporting regulators in inspection guidance before, during and after audits.

And finally, in 2017, FDA will round out its inspection, compliance and enforcement objectives by continuing to provide training and calibration support to inspectors with the goal of achieving a consistent approach in conducting inspections and decision-making. This will be accomplished through best practice webinars, training courses—including participation in standardized curriculum such as FSPCA courses and regulator specific training—mentoring, and the TAN. 

Lori Carlson provides independent technical writing, training and consultation services to the food and beverage industry. She has over a decade of experience in verification and validation, risk assessment, food safety and quality management systems, GFSI benchmarked schemes, regulatory compliance, and third party certification. Lori has authored numerous white papers, magazine articles and guidance documents and has contributed to the development of various food safety standards and food professional training courses for GFSI scheme owners and certification bodies. Contact the author through LinkedIn.