NCPA - National Center for Policy Analysis

Regulators Impede Biotech

December 11, 1995

Modifying the characteristics of plants, animals and microorganisms was a $100 billion industry even before the development of gene splicing in the late 1970s launched what is now call biotechnology. Under the Clinton Administration, the Environmental Protection Agency (EPA) and Food and Drug Administration (FDA) have slowed the development and marketing of new biotechnology products through additional regulations.

The National Academy of Sciences and other scientific organizations concluded that gene splicing wasn't fundamentally different from or riskier than older methods. At the FDA, biotech regulation was conducted scientifically for 15 years, resulting in the approval of more than 1,000 new products, including treatments for diseases ranging from cancer to cystic fibrosis and multiple sclerosis.

However, during the last three years, under FDA Commissioner David Kessler, the agency's biotech policy has changed. For example:

  • In the early 1980s it only required five months for the FDA to approve human insulin and 11 months to approve human-growth hormone, the first two therapeutic products from the new technology.
  • However, the marketing of a new long-shelf-life tomato was held up for four years while the FDA considered requiring notification before foods manufactured with new biotech techniques could be marketed.
  • In 1994, the FDA's Center for Veterinary Medicine announced that it would regulate the whole area of biotech techniques applied to animals, instead of considering the likely risks from particular products.
  • The use of the synthetic hormone BST to stimulate milk production in cows was delayed while the FDA searched for a reason to disapprove it, convening two scientific advisory committees that found it posed no danger to humans.

In addition, since the 1992 elections Kessler has eliminated the Office of Biotechnology and the Office of Small Business, Scientific and Trade Affairs, placing biotech policy direction in the hands of a political appointee, an executive assistant to the Commissioner.

The EPA has also proposed new regulations aimed at the technology used, rather than any risks associated with such products. Thus, in 1994, it proposed to regulate the small-scale testing of new varieties of plants more stringently than pesticides.

Source: Henry I. Miller, "Dark Science: Al Gore and the FDA," Weekly Standard, December 11, 1995.


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