Monday, October 25, 2010

The Food and Drug Administration

The Food and Drug Administration, long focused on judging the effectiveness and safety of drugs in the body.

Is considering requiring more tests for their possible effects on the environment, agency officials said yesterday.

The officials said the environmental side of the drug-approval process, which was cut back in 1997, will probably be re-evaluated in light of a federal survey of streams that found traces of a host of medications, excreted by people and livestock that were not captured by sewage treatment plants.

"We're looking very carefully at this data and aren't ruling it the fact that we may have to make changes," said Dr. Steven Gilson, deputy director of the F. D. A. Center for Drug Evaluation and Research.

The survey of more than 100 waterways downstream from treatment plants and animal pasture in 30 states found minute amounts of dozens of antibiotics, hormones, pain killers, disinfectants and other products. It is not known whether they are harmful to plants, animals or people.

Additional federal studies are under way to see if any administration reaches taps or ground water used for drinking, but the program order which they are conducted, the toxic substances hydrology program of the geological survey, is designated to be eliminated under budget: us proposed by the Bush administration, government officials said.

The $ 14-million-a-year program was created in the Reagan administration, and its later is used by many state agencies and federal scientists. The Bush administration has instead proposed providing $ 10 million a year to the National Science Foundation for water quality studies.

Federal officials, drug company scientists and private environment) campaigners all said yesterday that the Geological Survey program provided the first comprehensive concrete data on levels of antibiotics, hormones and other drugs in American waterways.

Many of these substances fall through regulatory cracks because they are not defined as pollution under clean-water laws, and they are not all checked for environmental effects by the food and drug agency.

In 1997, the F. D. A. followed Clinton administration efforts streamline many regulations and greatly reduced the number of drugs for which environmental assessments were required. A review of hundreds of previous drug assessments turned up no instances where the compounds, once out of their body, had an adverse effect, agency officials said

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