Introduction

A common perception is that the United States has lax regulation of gene tech­nology. If one examines the direct regulation of gene technology in the United States, it seems as if gene technology is relatively unregulated.

This dichotomy reflects how United States food law is organized around product characteristics rather than process characteristics. To be clear, processes are regulated, but this is largely as an effective means to regulate product char­acteristics. In addition, U.S. laws regulate products based on their specific intended uses. For instance, a pharmaceutical is regulated differently than a food, which is regulated differently than an industrial chemical.

There is strength in this approach. The main strength of this regulation by characteristic and use is that it allows science-focused attention on potential risk. Agencies and their scientists in respective areas of expertise are assigned to evalu­ate particular aspects of gene technology. For example, when protectant prop­erties are introduced into a plant, the U.S. Environmental Protection Agency (EPA), the federal agency with the expertise and responsibility for regulating pesticides, is assigned to review the pesticidal properties of the new plant variety.

However, there is also weakness in this approach. The main weakness of regulation by characteristic is that this approach may be obtuse to the public and fail to generate public confidence. There are three main federal agencies involved in the oversight of biotechnology, the U.S. Department of Agriculture (USDA), the Food and Drug Administration (FDA), and the Environmental Protection Agency. However, seven offices or centers within those three agen­cies handle different aspects of oversight.

DOI: 10.4324/9781003271918-5

Regulating Gene Technology in Food 45 framework for biotechnology products relies on several different laws, the nomenclature in these statutes for various actions is sometimes inconsistent, but this inconsistency in terms does not indicate that the reviews conducted by the different regulatory agencies are less rigorous.

Tables 4.1 and 4.2 illustrate the complex structure of the U.S. regulation of gene technology for food production. For instance, the FDA Center for Food Safety and Applied Nutrition (CFSAN) has oversight of the safety of foods derived via gene technology in plants or cultured cells, but the FDA Center for Veterinary Medicine (CVM) has responsibility for the oversight of the safety of food derived from gene technology in animals, along with the USDA Food Safety Inspection Service (FSIS) when the animal is one of the amenable spe­cies under the three inspection acts enforced by FSIS. The USDA Animal and Plant Health Inspection Service (APHIS) also becomes involved in oversight and approval when an animal- or plant-derived product from gene technology might pose a plant pest risk. The EPA Office of Pesticide Programs (OPP) has responsibility for the regulation of pesticide substances and related genetic material for human and environmental safety, including the safety of dietary exposure to pesticide residues in human and animal food. See Table 4.1.

Each agency uses already existing statutory authorities to ensure the safety of biotechnology products. These statutes define the boundaries and the scope of

Table 4.1 Oversight of gene technology in food products by EPA, FDA, and USDA¹

1 Adapted from FDA, USDA, EPA, “Modernizing the Regulatory System for Biotechnology Products: Final Version of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnol­ogy”, Jan.

The primary food safety statute is the Federal Food, Drug, and Cosmetic Act (FD&C Act). The statute mandates that the FDA ensure that all human food and animal feed is safe and that the EPA ensure that no harm will result from aggregate exposure to any pesticide residue, including all anticipated die­tary exposures and all other exposures for which there is reliable information. The EPA also bears responsibility under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for preventing and eliminating unreasonable adverse effects on the environment from any pesticidal property resulting from gene technology. For environmental and occupational risks, the EPA compares economic, social, and environmental risks to human health and the environ­ment and benefits associated with pesticide use. However, for dietary or human health effects, the sole standard is the safety of all combined exposures to the pesticide and related compounds.

The USDA under the Animal Health Protection Act (AHPA) protects livestock from animal pest and disease risks, and under the Plant Protection Act (PPA), it protects agricultural plants and agriculturally important natural resources from damage caused by organisms that pose plant pest or noxious weed risks. The USDA under the Federal Meat Inspection Act (FMIA), the Poultry Products Inspection Act (PPIA), and the Egg Products Inspection Act (EPIA) ensures that meat, poultry, and egg products are safe and wholesome. The National Environmental Policy Act (NEPA) requires that all federal agen­cies ensure that they give proper consideration to the environment before any major federal action, including approval of a product of biotechnology.

2 Ibid.

II.