FDA Draft Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon

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Draft Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon[附网盘链接]是Food And Drug Administration发布的FDA标准，适用于美国。

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Contains Nonbinding Recommendations Draft-Not for Implementation Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon: 1

Guidance for Industry This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or we) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page. I. Introduction This document provides guidance intended to assist food manufacturers that wish to voluntarily label their food products or ingredients (for humans or animals) derived from Atlantic salmon as 2 either containing or not containing products from genetically engineered (GE) Atlantic salmon. This document also provides guidance on voluntary statements that may be appropriate for species of salmon that have no GE counterparts. FDA’s main concern within the context of this guidance is that such voluntary labeling be truthful and not misleading. 1

This guidance has been prepared by the Office of Nutrition and Food Labeling in the Center for Food Safety and Applied Nutrition and the Office of the Director in the Center for Veterinary Medicine at the U.S. Food and Drug Administration. 2 In July 2016, the National Bioengineered Food Disclosure Standard (NBFDS), PL 114-216, was signed into law. This law amended the Agricultural Marketing Act and charged the U.S. Department of Agriculture’s (USDA) Agricultural Marketing Service (AMS) with developing a national mandatory standard for disclosing the presence of bioengineered material in human food. The term “bioengineered” as defined in that law includes products that are GE. The law primarily applies to human food derived from plants; however, it does apply to some animal-derived foods, including salmon. As a result, Federal law now requires that human food that is derived from or contains GE Atlantic salmon must bear a disclosure on the label that conforms to the national standard, as further defined through final USDA regulations. Therefore, FDA no longer has authority over voluntary labeling to indicate the presence of GE content in human foods, including salmon. FDA retains jurisdiction over labeling statements to indicate the absence of GE content in human food. The NBFDS does not apply to animal food. In light of the NBFDS and its implementing regulations issued on December 20, 2018, FDA is reviewing this draft guidance to consider what additional or new recommendations may be needed for the kinds of products or statements, including claims of non-GE content, that are not covered by the NBFDS.

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