Summary of FDA Guidance and Resources for FSMA Compliance

By Lori Carlson

Still wondering what the FDA expects from your operation to achieve compliance with Food Safety Modernization Act (FSMA) regulation? TUV USA is here to point you to some helpful guidance documents and websites that highlight industry resources, best practices and solutions for identifying and implementing effective controls.

Are you a food manufacturing or importer struggling with hazard analysis requirements of the Preventive Controls or Foreign Supplier Verification Program (FSVP) rules? Visit FDA’s draft guidance on Conducting a Hazard Analysis (Ch. 2) or Potential Hazards Associated with the Manufacturing, Processing, Packing, and Holding of Human Food (Ch. 3) for an in depth understanding of how to ensure your hazard analysis is thorough and accurate.

The FDA’s Hazard Analysis and Risk-Based Preventive Controls: Draft Guidance for the Industry is a document still in development with five chapters complete. This document is planned as an extensive compilation of FDA’s recommendations for developing and implementing food safety practices, which are consistent with the regulation.

The currently available chapters on hazard analysis may well serve those companies regulated by the Preventive Controls rule—and those at its periphery—still developing their food safety plans and working to identify significant hazards within their supply chain and operation. The agency expects to complete the remaining nine chapters by early 2018.

Additional agency-related resources include the Food Safety Preventive Controls Alliance (FSPCA) Resources page available from the Alliance website. Not only is the FSPCA website the authoritative source for training on the Preventive Controls, FSVP and Intentional Adulteration rules, but it also boasts helpful resources aimed at FSMA compliance.

This includes a web-based Resources by Chapter tool, which is a supplement to the Preventive Controls for Human Food (PCHF) course. PCHF Resources by Chapter presents external web links to FDA, USDA, World Health Organization (WHO), Center for Disease Control (CDC), trade association, and other valuable industry resources related to identifying food hazards and implementing effective controls.

And lastly, are you working through a vulnerability assessment and food defense mitigation plan for compliance with the Intentional Adulteration (IA) rule? FSPCA has you covered on that front as well with a series of hour long training webinars. FSPCA’s Intentional Adulteration webinars provide businesses guidance on interpreting IA rule requirements as well as training on conducting a vulnerability assessment and developing appropriate mitigation strategies. The first webinar in the series was recently presented on June 20, 2017 and focused on methods for conducting a vulnerability assessment. A recording of the webinar is freely available from the link above. Follow-up webinars in the series to discuss developing and implementing mitigation strategies are planned for August and October, 2017.

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About the Author

Lori Carlson

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.