Amendment Requires Scientific Evidence on Antibiotic Use

June 8, 2011 — 

An amendment to the fiscal 2012 agriculture appropriations bill passed by the House Appropriations Committee last week would require the U.S. Food and Drug Administration to use "hard science," including risk assessments, before restricting the use of animal health products.

According to the bill's language, FDA could not use funds to "write, prepare, develop or publish a proposed, interim, or final rule, regulation, or guidance that is intended to restrict the use of a substance or a compound unless the Secretary bases such a rule, regulation or guidance on hard science (and not on such factors as cost and consumer behavior), and determines that the weight of toxicological evidence, epidemiological evidence, and risk assessments clearly justifies such action."

FDA has proposed guidance that suggests that food-animal producers reduce the use of certain animal health products. The agency said the guidance would be used to develop public policy on animal antibiotic use. When it was proposed last June, the National Pork Producers Council warned that the guidance could lead to the elimination or costly review of previously approved animal health products.

The organization also said there appeared to be no science on which FDA based the guidance. NPPC repeatedly has pointed out that numerous peer-reviewed risk assessments show that the risk to public health from animal uses of antibiotics is negligible. The full House is expected to take up the agriculture appropriations bill the week of June 13.

Source: NPPC

By: PorkNetwork news source