Businesses face significant regulation bringing biotech products to market.

AuthorPARASCANDOLA, STEPHEN T.
PositionBiotechnology industry in North Carolina - Statistical Data Included

Biotechnology has existed since humans began domesticating plants and animals. The biotechnology of today, however, includes an astonishing array of emerging technologies such as genetic engineering, by which scientists place foreign DNA into an organism to create new life forms with novel and useful traits. Genetic engineering has resulted in genetically modified food crops, edible vaccines and anti-coagulant compounds, the enhancement of vitamins and minerals and the production of numerous anti-cancer and cholesterol-fighting substances.

The possibility of creating new treatments for disease and environmental contamination, safer food products and less damaging chemicals has spurred incredible business growth. In North Carolina alone, biotechnology and related bioscience technologies are projected to generate up to $15 billion in annual product sales and employ as many as 100,000 people within the next 15 years. It

is anticipated that biotech and related "life sciences" technologies will continue representing one of the fastest growth industries in the United States.

New technologies, new regulation

Accompanying the biotech boom is a rising tide of regulatory scrutiny. The diversity of biotechnology-generated applications, combined with the myriad substances and processes used by these technologies, result in federal regulation under more than one government agency. It is anticipated that a growing public concern about the safety of new biotechnology products may drive even more regulatory scrutiny and restrictions in the future. Three federal agencies are primarily in charge of regulating biotechnology companies in the United States: the Environmental Protection Agency, the Food and Drug Administration and the Department of Agriculture. In addition, the Occupational Safety and Health Administration is charged with protecting the health and safety of employees in the workplace, including those involved in biotechnology operations.

Laws enforced by the EPA

The EPA is responsible for protecting the environment and safeguarding human health. In this role, the agency is charged with regulating hundreds of substances and materials that could adversely affect the environment. The primary laws used by the EPA to regulate the field of biotechnology are the Toxic Substances Control Act and the Federal Insecticide, Fungicide and Rodenticide Act. Although it is not widely known, the EPA also administers certain portions of the Federal Food, Drug and...

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