FDA released its Draft Guidance for FSMA Preventive Controls for Human Food Rule. This guidance is scheduled to appear in the Federal Register on August 24, 2016. FDA will provide a 180-day public comment period in which it will seek input from stakeholders (comments due on February 21, 2017). Below are several points that were made during a public FDA stakeholders’ conference call announcing the guidance. In addition, below is the summary from Covington related to several FSMA compliance date extensions.
- The Draft Guidance for FSMA Preventive Controls is the first five chapters of the guidance document. Additional guidance document chapters will continue to be released by the FDA through 2018. It is anticipated that the next set of chapters will be released within about a year.
- FDA will be releasing separate guidance documents for the supply chain requirements of the FSMA rule as well as the notifications/assurances portions of the Preventive Controls rule. It was implied that both of these could be out soon as FDA is very aware that the compliance date for the Preventive Controls rule is next month.
- FDA plans to hold a webinar on the draft guidance document on September 19th. More details will be posted by FDA regarding how to register for this webinar.
- Covington Summary
FDA Extends Compliance Dates for Certain Provisions of FSMA Rules
August 23, 2016
Food, Beverage, and Dietary Supplements and Animal Food and Drug
FDA has issued a final rule extending and clarifying the compliance dates for certain provisions of four final rules recently issued as part of the agency’s implementation of the FDA Food Safety Modernization Act (“FSMA”). According to the agency, the compliance dates are being extended to address concerns about the practicality of compliance with the specific regulatory provisions, to give FDA time to consider the regulatory text, and to better align the dates across the rules. Most of the date changes apply only to a narrow set of activities, and the major compliance dates for large companies remain the same. Significantly, however, the rule extends for two years the compliance dates for the written assurance provisions in the Human PC Rule, 21 C.F.R. §§ 117.136 and 117.137, and the parallel provisions in the Animal PC Rule in 21 C.F.R. §§ 507.36 and 507.37, which had been of great concern to many industry stakeholders, and FDA continues to consider the best approach to address stakeholders’ feasibility concerns about these provisions. Read the Full Article
For more information visit:
- Food Safety Modernization Act: Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules
- Compliance Date Extensions and Clarifications for FSMA Final Rules
- Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food