A FSMA Milestone 

As I prepare this FSMA Perspective article, we are anticipating a significant milestone in the implementation of FSMA’s preventive control philosophy – release of a final rule on current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food and a separate final rule on cGMPs and preventive controls for animal foods.

Because they were developed with a high degree of transparency and collaboration between the Food and Drug Administration and stakeholders, hopefully neither final rule will contain big surprises.

But there is still a lot more FSMA work to be done. A quick review of FDA’s open dockets relating FSMA provisions indicates the size and scope of this ongoing regulatory undertaking. The open dockets include 12 guidance documents, three draft guidances and one significant proposed rule – on user fees for accreditation of third-party auditors and certification bodies to conduct food safety audits and issue certifications. Comments on that proposal are due by October 7, 2015.

The guidance includes:

• Draft guidance for industry and FDA staff on Third-Party Auditor/Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards (FDA-2011-N-0146 Comments due October 7, 2015)
• Draft guidance for industry on FDA’s Voluntary Qualified Importer Program (FDA-2011-N-0144)
• Prior Notice of Imported Food Questions and Answers – Edition 3 (FDA-2011-N-0179)
• Questions and Answers Regarding Food Facility Registration (Sixth Edition) (FDA-2012-D-1002)
• What You Need to Know About Establishment and Maintenance of Records; Small Entity Compliance Guide (FDA-2013-N-1421)
• FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act (FDA-2011-D-0674)
• What You Need to Know About Administrative Detention of Foods; Small Entity Compliance Guide (FDA-2011-D-0643)
• What You Need To Know About Registration of Food Facilities; Small Entity Compliance Guide (FDA-2012-D-1003)
• Questions and Answers Regarding Food Facility Registration (Fifth Edition) (FDA-2012-D-1002)
• Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories (FDA-2012-D-0585)
• Questions and Answers Regarding Establishment and Maintenance of Records By Persons Who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food – Edition 5 (FDA-2011-D-0598)
• What You Need to Know About Administrative Detention of Foods (FDA-2011-D-0643)
• Implementation of the Fee Provisions of Section 107 of the FDA Food Safety Modernization Act (FDA-2011-D-0721)
• Fish and Fishery Products Hazards and Controls Guidance (FDA- 2011-D-0287)

In the next FSMA Perspective, I hope to be able to review the new preventive controls rules for human and animal food. In the meantime, I would like to draw your attention to a series of FDA instructional webinars that deal with implementing the preventive controls rules. The agency presented an August 27 session on industry best practices for supplier management. The next webinar in the series, on October 22, 2015, will deal with minimizing allergens.