USDA's Procedure For Regulating Transgenic Organisms

Under the Plant Protection Act (“PPA”) USDA requires that anyone desiring to import, transport interstate, or plant a “regulated article” must apply for a permit or make a notification to APHIS that an introduction will be made.

Introduction to The Regulation of Genetically Modified Organisms by the USDA

Introduction to The Regulation of Genetically Modified Organisms by the USDA

The United States Department of Agriculture shares significant regulatory authority over GM crops with FDA and EPA. Transgenic, or genetically modified, plants are regulated by USDA’s Animal and Plant Health Inspection Service (“APHIS”) under the Plant Protection Act (“PPA”).

The Food and Drug Administration's Policy on Genetically Modified Foods

The FDA’s regulatory approach thus focuses on the end product, rather than the process used to create genetically modified foods. In short, the FDA regards GM products as “generally regarded as safe,” (“GRAS”) and does not subject GM food products to food additive review.

Introduction To The Regulation of Genetically Modified Foods by the FDA

Introduction To The Regulation of Genetically Modified Foods by the FDA

The Food and Drug Administration is the lead regulatory agency of food articles. It is in charge of ensuring the safety and effectiveness of food (other than meat), food additives, medical devices, drugs, veterinary drugs, cosmetics and genetically engineered food.

Environmental Protection Agency's Role Under the Toxic Substances Control Act

TSCA provides the EPA with authority to regulate chemical substances which may present an unreasonable risk of injury to health or the environment during manufacture, processing, distribution in commerce, use, or disposal. TSCA applies to uses of substances that are not specifically covered by another statute, i.e., TSCA does not apply to pesticides, food, drugs or cosmetics. TSCA is therefore a “catch-all” or “gap-filler” statute.

Environmental Protection Agency's Role Under Federal Food, Drug and Cosmetic Act

In the case of herbicide-tolerant crops, EPA establishes tolerances for the allowable amount of herbicide residues that may remain on the crop.

Environmental Protection Agency's Role Under The Federal Insecticide, Fungicide, and Rodenticide Act

EPA uses its authority under FIFRA to regulate plant incorporated protectants, or substances produced to control pests, both, to ensure that the production of such a pesticide in plants is safe for the environment, and to establish allowable levels of the pesticide in the food supply.

U.S. Regulatory Regime of GMO’s – Jurisdiction Of The EPA

U.S. Regulatory Regime of GMO's - Jurisdiction Of The EPA

Any substance produced and used in a living plant, whether through conventional breeding or genetic modification is regulated by the EPA if it is intended to control pests. As such, the EPA has a role in regulating the several types of genetically modified organisms.

Introduction to the U.S. Regulatory Regime for GMOs

Presently, it is questionable whether the genetically engineered foods are adequately controlled and/or regulated under U.S. law. There is no single federal statute or federal agency that governs the subject matter. Three federal agencies are primarily responsible for the regulation of genetically engineered foods – the Food and Drug Administration (FDA), the Environmental Protection Agency (EPA), and the U.S. Department of Agriculture (USDA).

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