Agricultural Biotechnology and APHIS Regulations: A Pathway to the Future

by Charles Kastner, Senior Regulatory Analyst, Biotechnology, Biologics, and Environmental Protection, Animal and Plant Health Inspection Service, USDA, Hyattsville, MD.

Biotechnology emerged as a powerful tool in the 1980's from breakthroughs in the biological sciences that had occurred during the previous decades.

Biotechnology is defined as any technique that uses living organisms or substances to make or modify a product, to improve plants or animals, or to develop micro-organisms for specific purposes.

In the 1990's, world agriculture needs the innovative potential of biotechnology to meet the dual challenges of feeding a growing human population and solving environmental problems.

The regulatory system of the Animal and Plant Health Inspection Service (APHIS) seeks to ensure the safe transfer of biotechnology from the laboratory to the farm. Through this process, APHIS acts to protect plant and animal health and acts as a catalyst for technology transfer.

A Crucial Time in Human History. The emergence of agricultural biotechnology comes at a crucial time in human history. In the past 50 years, the world's human population has increased from 2 billion to 5 billion, and demographers predict that it will rise to 6.1 billion by the year 2000. In this decade, 80 percent of this growth will take place in developing countries among the rural poor. Even now, at least 500 million people in Asia, Africa, and Latin America do not have enough food to eat, and a half billion more are at constant risk of hunger.

Over the past 50 years human beings have met the demand for increased food production by bringing new land into production and by making intensive use of new technology. In the 1990's, we find that new fertile farmland, the first part of the food production equation, is no longer available. Farmers have already now brought most of the good agricultural land into production and used nearly all of the irrigation water, and they are now rapidly depleting the ground water. In the 1990's productivity will have to come from innovation, not new land.

Biotechnology offers the chance for a new, more environmentally benign burst of productivity to meet world food needs. The alternative is to bring more marginal land into production, which would accelerate deforestation, erosion, and the loss of biodiversity, and condemn more of humanity to malnutrition.

Animal Health

Biotechnology is already playing a significant role in combating animal diseases. Vaccines derived from biotechnology, diagnostics, and other veterinary biological products are helping to reduce diseases that rob farm production of at least 10 percent of its value each year. Examples of licensed products derived from biotechnology include subunit vaccines, gene-deleted viral vaccines, and diagnostics using monoclonal antibodies, Enzyme-Linked Immunosorbent Assay (ELISA) kits, and amplified DNA probe kits. Additional products under development include cytokines, recombinant vaccinia, and other viral vectored vaccines.

In the developing world, diagnostic test kits for rift valley fever, foot and mouth disease, and other destructive diseases offer the chance for quick intervention to reduce the spread of disease from infected animals.

Biotechnology also holds the promise of controlling complex vectorborne parasite diseases, such as trypanosomiasis, that now make large tracts of sub-Saharan Africa unusable for livestock grazing. In the future researchers may be able to provide a herd owner with a single vaccinia vectored vaccine that would immunize livestock against several different diseases.

In the developed market economies of the world, biotechnology offers improved biologics to control the spread of disease in large-scale production of livestock. For example, APHIS licensed the first amplified DNA probe kit for an animal disease. The kit dramatically reduces the time it takes to identify the bacteria causing paratuberculosis, a serious disease common in dairy cows.

APHIS licenses both biotechnologically derived and conventionally produced veterinary biological products that are sold, distributed, or manufactured in the United States, to ensure that they are pure, potent, safe, and efficacious. This assurance of product quality plays a key role in protecting America's multibillion-dollar livestock and pet industry.

Dr. Alda Giron, at DIGESEPE Laboratory in Guatemala City, Guatemala, uses a diagnostic test kit to test for foot and mouth disease. The test kits offer the chance for quick diagnosis to reduce the spread of disease from infected animals. Laurie Smith/USDA 92BW0821