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The SECURE Rule: New Regulations for Crop Biotechnology in the United States journal article

Margaret Rosso Grossman

European Food and Feed Law Review, Volume 15 (2020), Issue 6, Page 548 - 562

In May 2020, the US Department of Agriculture enacted new regulations to govern genetically engineered organisms. The 2020 Rule focuses on the products of biotechnology and is designed to accommodate future innovation. The Rule defines genetic engineering broadly, but establishes exemptions from regulation, including certain organisms developed with innovative plant breeding techniques such as genome editing. It allows developers to determine that their new organisms are exempt, with a voluntary USDA process to confirm the exemption. A new Regulatory Status Review uses scientific risk assessment to determine whether an organism poses a plausible plant pest risk and is therefore subject to regulation. Organisms that pose plant pest risks, products intended for pharmaceutical or industrial use, and certain other GE organisms require permits for interstate movement, import, or release into the environment. The 2020 Rule reduces the regulatory burden for developers whose organisms are unlikely to pose a plant pest risk and reserves stricter USDA oversight for organisms that pose risk. Criticisms of the 2020 Rule focus on exemptions and self determination and on the possible impact of the Rule on trade.



Labeling Bioengineered Food in the United States journal article

Final Regulations from the US Department of Agriculture

Margaret Rosso Grossman

European Food and Feed Law Review, Volume 14 (2019), Issue 2, Page 142 - 151

Since the commercialization of genetically modified crop varieties, food produced from those varieties has been sold in the United States without mandatory labels to identify genetically modified content. Under a federal statute enacted in 2016 and implemented by final regulations promulgated in 2018, foods defined as ‘bioengineered’ must bear labels that disclose bioengineered food or food ingredients. These measures, which apply only to detectable bioengineered ingredients, establish detailed standards for disclosure, including a labeling threshold, several methods of disclosure, and exemptions from disclosure. Although the statute and regulations have been criticized, mandatory labeling will enhance transparency by informing consumers about genetically modified ingredients in their food.





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