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B-114836 1 (1978-05-04)

handle is hein.gao/gaobachkr0001 and id is 1 raw text is: &18 COMPTROLLER GENERAL OF THE UNITED STATES WASHINGTON, D.C. 20545 r? Alt A 1978 B-114836 The Honorable Harrison A. Williams, Jr. Chairman, Committee on Human Resources United States Senate Dear Mr. Chairman: As requested in your letter dated February 20, 1978, we have the following comments on S. 2540, 95th Congress, which if enacted will be known as the Food Amendments Act of 1978. The bill contains a number of provisions that should (1) pro- vide greater protection to the public from adulterated foods., (2) provide better information to consumers, and (3) result in more efficient and effective enforcement of the Federal Food, Drug, and Cosmetic (FD&C) Act (21 U.S.C. 301) by the Food and Drug Administration (FDA).-- Many of the bill's proposed amendments to the FD&C Act are consistent with conclusions and recommendations contained in General Accounting Office reports issued to the Congress. Pertinent sections of these reports are briefly discussed below. 1. In our report entitled Dimensions of Insanitary Conditions in the Food Manufacturing Industry (B-164031(2), April' 18:,: 1972):, we pointed out- that -FDA- needed- to take mor.e aggressive regulatory action when the reinspection of a plant-. historically shows a disregard-for sanitation--standards.-- Enforcement alternatives provided by the FD&C Act include criminal penalties, injunctions, and letters of warning. In our opinion, .the difference between the rather severe conse- quences of criminal penalties o'r injunctions, which FDA stated it was reluctant to initiate, and the relatively inconsequen- tial letters of warning indicated that intermediate enforce- ment powers, such as civil penalties, would provide an effec- tive means to obtain timely corrective action. Accordingly, we suggested that the Congress amend the law to provide for civil penalties. Section 6 of the bill would add to the FD&C Act section 308 to provide for civil' penalties which would allow FDA greater flexibility in enforcing the act. Also, we pointed out that FDA needed a complete and accurate inventory of food manufacturing plants to (1) know' HR.-BILL-8

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