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- FDA Issues a Final Rule on Substances Generally Recognized as Safe
FDA Issues a Final Rule on Substances Generally Recognized as Safe (GRAS) for Their Intended Use in Food
August 17, 2016 , Covington Alert
This morning, August 17, 2016, FDA published in the Federal Register its final rule on substances generally recognized as safe (GRAS) for their intended use in food. Coming nineteen years after the proposed rule, under which industry has effectively been operating for some time, the final rule mostly codifies the status quo. The final rule formalizes, through regulation, the voluntary notification program that has been running as an interim pilot for nearly two decades. It also modernizes the regulations in a few key respects, sweeping out obsolete provisions about a GRAS petition process that is no longer used and replacing them with a description of the voluntary GRAS notification procedure already familiar to the food industry.
November 2, 2016, Covington Alert
Last week, FDA released a draft guidance1 clarifying requirements for the “disclosure statement” provisions of its four major Food Safety Modernization Act (FSMA) rules. Entities subject to these provisions must disclose, in documents accompanying the food, that certain hazards have not been controlled. The draft guidance provides insight into the circumstances in which FDA would expect covered entities to utilize the “disclosure statement” provisions, explains how the covered entity should describe the identified hazard, and discusses what type of documents may be used for the disclosure statement. Additionally, FDA reminds industry stakeholders that the entity receiving such a disclosure statement is responsible for taking appropriate steps to ensure that the identified hazards are controlled before the food reaches the consumer.
August 24, 2016, Law360
April 7, 2016, Covington Alert
Yesterday, FDA published in the Federal Register its final rule establishing sanitary transportation requirements for both human and animal food. The rule is intended to ensure that food transportation practices do not create food safety risks. FDA provides a flexible, risk-based approach that largely aims to allow the transportation industry to continue to use industry best practices that are likely already in place concerning cleaning, inspection, maintenance, loading and unloading of, and operation of vehicles and transportation equipment to satisfy the requirements in the final rule. These requirements also align in part with the hazard analysis and risk-based preventive controls requirements for food facilities that were established in FDA’s preventive control final rules for human food and animal food released earlier this year.