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USDA Seeks Lightning-Speed Industry Input for Upcoming Proposed Bioengineered Food Disclosure Rule

USDA’s Agricultural Marketing Service (AMS) posted 30 questions for stakeholder input regarding the establishment of a national disclosure requirement for identifying bioengineered foods and food ingredients. The legislation requiring the disclosure of bioengineered foods was enacted on July 29, 2016, and gave AMS two years to establish a national standard and the procedures necessary for implementation (see New GMO Legislation Signed Into Law, for more information on the legislation). AMS is now seeking input from stakeholders in order to issue a proposed rule this fall, such that it may promulgate a final rule by the mandated July 2018 deadline.

With regard to the questions posed, several go to the scope of what will be considered a “bioengineered” food, including whether a bioengineered food should include highly refined products such as oils or sugars derived from crops, or what amount of a bioengineered substance would make a food be deemed “bioengineered.” Other questions seek information regarding the types of disclosures that would be adequate under the standard (e.g., text, symbols, electronic links) and the types of products that may be exempt from the disclosure requirement or that may be permitted to bear alternative disclosures (e.g., bulk products or small packages). AMS also asks what types of records would establish regulatory compliance and what an appropriate adjudication process would be like for audits and compliance actions.

As we have recommended in the past, food companies should participate in the rulemaking process given that the scope of the disclosure standard, as well as timing and logistics, pose challenges to the industry.

An unusually short time frame has been provided to submit comments to the USDA on this matter—about three weeks. Responses to the questions should be submitted to by July 17, 2017.

Copyright © 2020 by Morgan, Lewis & Bockius LLP. All Rights Reserved.National Law Review, Volume VII, Number 193


About this Author

Ann Begley, Regulatory and compliance lawyer, Morgan Lewis

Ann M. Begley advises clients on a range of US Food and Drug Administration (FDA) legal and regulatory issues relating to drug, cosmetic, dietary supplement, food, and medical device products, with an emphasis on matters involving clinical practice and over-the-counter (OTC) drugs. Ann counsels institutional review boards, clinical investigators, and sponsors on compliance and strategic issues. She also provides extensive guidance on product approval pathways, formulation, labeling, and product advertising.

Robert Hibbert, Civil litigation attorney, Morgan Lewis

Robert G. Hibbert advises clients in the food and agricultural industries on federal regulation, particularly relating to the US Department of Agriculture (USDA), as well as the US Food and Drug Administration (FDA). Clients seek his counsel on labeling, advertising, recalls, food safety compliance, animal health, and new product development issues. Bob’s experience with civil litigation in federal court includes successful challenges to the scope of USDA jurisdiction and authority over major segments of the food processing industry.

Hilary Lewis, Morganlewis, FDA lawyer, consumer product attorney, medical device

Hilary L. Lewis counsels clients on US Food and Drug Administration (FDA), US Department of Agriculture (USDA), Federal Trade Commission (FTC), and state regulatory compliance issues involving food and dietary supplements, over-the-counter and prescription drug products, and cosmetics. Hilary applies her background litigating on behalf of FDA-regulated companies to assist clients in their defense against FDA, USDA, and Consumer Product Safety Commission (CPSC) enforcement actions, and has helped companies resolve import detentions, manage product recalls...