November 13, 2015

TO: JPA Members

FROM: Patricia Faison

JPA Regulatory Update: FDA Publishes Three FSMA Final Rules/Stakeholder Briefing Scheduled Today

Today, the Food and Drug Administration (FDA) issued a press release, available here, announcing publication of three FDA Food Safety Modernization Act (FSMA) final rules. The prepublication version of the FSMA final rules may be accessed via the links below. The formal documents will be published in the Federal Register on November 27, 2015. In addition, the Agency has published a number of Fact Sheets, accessed via the links below, which provide an overview of the final rules. The FDA announced a stakeholder briefing will be held today at 1:00 p.m. (Eastern). Details regarding the conference call are available below. Details are also provided below regarding two FSMA webinars.

JPA staff is in the process of reviewing the final rules and will provide additional details in the near future.

Final Rules

The FDA also announced via a Constituent Update, available here, the release of a Final Environmental Impact Statement (EIS) and Record of Decision (ROD) regarding the produce safety rule. The EIS provides insight on the potential environmental effects of the produce safety rule. The FDA notes the ROD “explains how the provisions in the final rule best meet FDA’s public health goals while minimizing environmental impacts as much as possible.” The prepublication Federal Register notice is available here. Links to access the EIS and ROD are available via the Constituent Update.

FSMA Fact Sheets on the Final Rules

Stakeholder Conference Call

The FDA will host a stakeholder briefing today (November 13, 2015) at 1:00 p.m. EST. The call-in number is 800-857-9715 or 1-517-308-9231 (for international callers). The passcode for all callers is “INDUSTRY”. Details provided by the Agency are below.

Mr. Michael R. Taylor, J.D., Deputy Commissioner for Foods and Veterinary Medicine, will provide an overview of the final rules and will be joined by Susan T. Mayne, Ph.D., Director, Center for Food Safety and Applied Nutrition, and Dr. Dan McChesney, Director of the Office of Surveillance & Compliance in FDA’s Center for Veterinary Medicine. Also participating are FDA experts on the rules: Dr. Samir Assar, Director of the Produce Safety Staff in the FDA’s Center for Food Safety and Applied Nutrition; Brian Pendleton, Senior Policy Advisor in FDA’s Office of Policy; and Charlotte Christin, Senior Policy Advisor, on detail to FDA’s Office of Foods & Veterinary Medicine. A Question and Answer Session will follow the presentation. Teresa Rubio, Health Programs Coordinator with the FDA Office of Health and Constituent Affairs, will moderate the call.

A replay of the briefing will be available one hour after the call ends until December 13, 2015. To hear the replay, callers in the United States should dial 866-501-2957, and international callers may dial 203-369-1825. The passcode for the replay is 111315.

FSMA Webinars

The FDA also announced that two webinars will be held to review the final rules:

• November 17, 2015, 2:00 p.m. – 3:00 p.m. (ET) – Produce Safety Final Rule

• November 23, 2015, 10:00 a.m. – 11:30 a.m. (ET) – Foreign Supplier Verification Programs and Third-Party Accreditation

Details regarding these webinars are available here.

As always, please contact me with questions or comments.

Patricia Faison

(404) 252 - 3663

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