Regulating the Environmental Risks
A. National Environmental Policy Act
The National Environmental Policy Act establishes the consistent process by which federal agencies must consider the consequences of their proposed actions on the human environment before a decision.[175] NEPA requires federal agencies to prepare a detailed “environmental impact statement” (EIS) for all major federal actions significantly affecting the quality of the human environment.[176]
Food additive approvals are also subject to the National Environmental Policy Act requirements.
Similarly, the potential environmental impacts of genetically engineered animals must be examined before they are approved under the NEPA. However, confidential requirements for new drug applications generally prevent FDA from releasing information in a new animal drug application before approval of the new animal drug. To encourage public transparency, FDA has sought permission of the drug sponsor to allow and consider public input in the agency’s evaluation of the potential effects on the environment from an investigational use or approval of a genetically engineered animal.B. EPA
1. Federal Insecticide, Fungicide, and Rodenticide Act
Under FIFRA, the EPA regulates the sale, distribution, and use of all pesticides, including those produced through gene technology.[177] An application to EPA for a pesticide registration requires extensive scientific data and information on the environmental effects of a pesticide. EPA must establish that the pesticide cannot harm non-target organisms, including humans, wildlife, and plants, and cannot harm endangered species. For an applicant to generate data, the EPA may allow field testing through an experimental use permit (EUP). The EUP will require controls be put in place to prevent unreasonable adverse effects on health and the environment.
When the pesticide is a genetically engineered microorganism, the applicant must notify EPA before testing. EPA may issue an EUP only when the test will not cause unreasonable adverse effects on the environment.[178] As needed to protect the environment, the EPA may place obligations in connection with the registrations, which may include, among other things, record-keeping requirements and limits on sale, distribution, and use.2. Toxic Substances Control Act
Under the Toxic Substances Control Act (TSCA), the EPA has oversight authority and responsibility for non-food commercial and industrial applications of microbial gene technology.[179] All “new chemical substances,” including microorganisms subjected to gene technology, are under TSCA pre-manufacturing review to prevent the manufacturing, processing, distribution in commerce, use, or disposal from presenting an unreasonable risk of injury to health or the environment, including to a potentially exposed or susceptible population.
C. USDA
The USDA Animal and Plant Health Inspection Service is responsible for protecting agriculture from pests and diseases. The Animal Health Protection Act (AHPA) and the Plant Protection Act (PPA) give USDA the authority and responsibility to regulate products of gene technology that may pose a risk to agricultural plant and animal health. The AHPA gives USDA regulatory oversight over any products of gene technology that are pests to or cause disease in livestock. The PPA gives USDA regulatory oversight over products of gene technology deemed plant pests or noxious weeds.
In addition, the USDA must comply with the provision of NEPA in its decision making. Thus, for example, before authorizing a genetically engineered plant, the USDA must take a hard look at the environmental impact of that decision. The USDA APHIS prepares either an environmental assessment (EA) or the more comprehensive environmental impact statement before making decisions about issuing permits. Draft EAs and EISs are published in the Federal Register, and the public has an opportunity to comment, which the agency considers before publishing the final version of the EA or EIS.
IV.
More on the topic Regulating the Environmental Risks:
- Regulating Food Safety Risks
- The Risks Associated With the Development of SME Operations via E-Commerce
- Regulating Gene Technology in Food
- Regulating Nanomaterials in Food as Product Category
- Perennial agriculture uses crops that do not need to replanted each year, which results in a number of environmental and climate benefits.330
- Lehner Peter. Farming for Our Future: The Science, Law and Policy of Climate-Neutral Agriculture. Environmental Law Institute,2021. — 255 p., 2021
- A variety of federal, state, and local agencies outside of the U.S. Department of Agriculture (USDA) support or regulate agricultural production.
- Notes on the Contributors
- The Response of the FDA to Antibiotic Resistance Due to Overuse in Food Animals
- At first glance, reducing net agricultural greenhouse gas emissions through public law poses a considerable challenge.
- The Evolution of Rules Concerning “Novel Food” in China
- About the Authors
- After having treated, in the first two chapters, the problems of mandatory norms — rules and principles — and of power-conferring rules, purely constitutive rules and definitions, we will now set out to examine permissive sentences.
- Criminal Law and Procedure
- The food system encompasses the full life cycle of food. In addition to agriculture, this includes activities that take place off the farm
- Curbs on rapacity: jurisdiction
- Concluding Remarks