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GAO-01-285R 1 (2000-12-20)

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       Accountability * Integrity * Reliability
United States General Accounting Office
Washington, DC 20548

          B-286970



          December 20, 2000

          The Honorable Richard G. Lugar
          Chairman
          The Honorable Tom Harkin
          Ranking Minority Member
          Committee on Agriculture, Nutrition, and Forestry
          United States Senate

          The Honorable Thomas J. Bliley, Jr.
          Chairman
          The Honorable John D. Dingell
          Ranking Minority Member
          Committee on Commerce
          House of Representatives

          Subject: Department of Health and Human Services, Food and Drug Administration:
                  Food Labeling, Safe Handling Statements, Labeling of Shell Eggs;
                  Refrigeration of Shell Eggs Held for Retail Distribution

          Pursuant to section 801(a)(2)(A) of title 5, United States Code, this is our report on a
          major rule promulgated by the Department of Health and Human Services, Fo o d and
          Drug Administration (FDA), entitled Fo o d Labeling, Safe Handling Statements,
          Labeling of Shell Eggs; Refrigeration of Shell Eggs Held for Retail Distribution (RIN:
          0910-AB30). We received the rule on December 13, 2000. It was published in the
          Federal Register as a final rule on December 5, 2000. 65 Fed. Reg. 76092.

          The final rule revises FDA's food labeling regulations to require a safe handling
          statement on cartons of shell eggs that have not been treated to destroy Salmonella
          microorganisms. The rule also requires that, when held at retail establishments,
          shell eggs be stored and displayed under refrigeration at a temperature of 7.2°C
          (45°F) or less.

          Enclosed is our assessment of the FDA's compliance with the procedural steps
          required by section 801(a)(1)(B)(i) through (iv) of title 5 with respect to the rule.
          Our review indicates that the FDA complied with the applicable requirements.


GAO-01-285R

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