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HRD-77-81 1 (1977-06-27)

handle is hein.gao/gaobaacjh0001 and id is 1 raw text is: 





                         DOCUMENT RESUME           ,2/     ,2

02513 - [A1852875] (*&ZtV1ite4-

Need to Establish Safety and Effectieness of Antibiotics Used
in Animal Feeds. HRD-77-81; B-164031(2). June 27, 1977. 47 pp. +
2 appendices (5 pp.).

Report to Rep. John Z. Ross, chairman, House Committee on
Interstate and Foreign Commerce: oversight and Investigations
Subcommittee; by Elmer B. Staats, Comptroller General.

Issue Area: Consumer and Worker Protection: Identifying Needs
    for Standards and Regulations (901); Food (1700) ;Consumer
    and Worker Protection: Standards, Laws, and Regulations
    Enforcement (903).
Contact: Human Resources Div.
Budget Function: Health: Prevention and Control of Health
    Problems (553); Agriculture (350).
Organization Concerned: Dpartment of Health, Education, and
    Welfare; Food and Drug Administration.
Congressional Relevance: House Committee on Interstate and
     Foreign Commerce: oversight and Investigations Snbcommittee.
 Authority: Federal Food, Drug, and Cosmetic Act, as amended (21
     U.S.C. 301 et seq.). Food Additive Amendments of 1958 (P.L.
     85-929). Drug Amendments of 1962 (P.L. 89--781). 21 U.S.C.
     360 et seq. 21 C.F.R. 514.1 et seq.

          The Food and Drug Administration (FDA) has permitted
 the continued use of low levels of several antibiotics in animal
 feeds. Findings/Conclusions: The Sdfety and effectiveness of
 the continued use in animal feeds of several antibiotics,
 particularly penicillin, tatraclclines, and sulfaquinoxaline,
 has not been established. The possibility ekists that
 antibiotic-resistant bacteria may develop, and that this
 resistance may be transferred from animal to man. on April 15,
 1977 the FDA decided to restrict the use of these drugs in
 animal feeds. Questions are raised concerning the use of the
 Rational AdvLsory Food and Drug Committee by the FDA, including
 insufficient expertise, conflict of interest, and improper
 involvement in regulatory matters instead of policy only.
 Recommendations: FDA shodld determine the safety and
 effectiveness of antibiotics used in animal feeds based on
 available data,and withdraw approval of any not shown to be safe
 and effective. Policy advisory committees should be used only to
 review brot-1 policy questions in accordance with FDA
 regulations, and their members made aware of their
 responsibilities with regard to and the restrictions of
 conflict-of-interest laws and regulations. (Author/DJ?,)

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