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RCED-92-256R 1 (1992-08-21)

handle is hein.gao/gaobackdy0001 and id is 1 raw text is: UntdStates General Accounting Office Washington, D.C. 20548 Resources, Community, and Economic Development Division B-24 96 36 August 21, 1992 147883 The Honorable Barbara Boxer House of Representatives Dear Mrs. Boxer: This letter responds to your request that we review the scientific adequacy of documentation compiled by the Food and Drug Administration (FDA) in support of its decision to (1) raise the amount of selenium permitted as an additive/supplement to animal feeds and (2) eliminate requirements for the analysis of each batch of selenium mixture (called premix) manufactured for use in animal feedstuffs. Selenium is an essential nutrient for the normal growth and development of animals. However, selenium in greater than minute (trace) amounts is toxic to human and animal life. According to FDA, the minimum dietary requirement for selenium ranges from 0.1 to 0.5 parts per million (ppm), depending on animal species, age, and other factors. Although selenium is a natural element found all over the world, FDA estimates that about 70 percent of the basic feedstuffs grown domestically do not contain enough selenium to meet the nutritional needs of animals. FDA first approved the use of selenium in small amounts as an animal feed additive in 1974 in response to a feed industry petition. FDA also required industry to analyze each batch of selenium premix to ensure that established maximum allowable levels of selenium were not exceeded. After issuing a final rule amending the selenium food additive regulation on April 6, 1987, FDA received numerous comments objecting to the increased levels of selenium allowable in animal feedstuffs. Commenters raised questions regarding the adequacy of the scientific data used to reach the decision and the potential harmful effect that increased levels of selenium might have on the environment when leached from animal wastes (manure and urine). GAO/RCED-92-256R, Selenium in Animal Feeds oS 6I /

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