XXV\. Analysis of Environmental Impact

We have carefully considered the potential environmental effects of this
action. We have concluded under 21 CFR 25.30(h) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

XXVI\. Federalism

We have analyzed this final rule in accordance with the principles set
forth in Executive Order 13132. We have determined that the interim
final rule does not contain policies that have substantial direct
effects on the States, on the relationship between the National
Government and the States, or on the distribution of power and
responsibilities among the various levels of government. Furthermore, we
did not receive any comments from States or their representative
organizations regarding to our analysis of the proposed rule regarding
the principles set forth in Executive Order 13132. Accordingly, we
conclude that the final rule does not contain policies that have
federalism implications as defined in the Executive Order and,
consequently, a federalism summary impact statement is not required.

XXVII\. References

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2\. U.S. Food and Drug Administration, Memorandum of Site Visit, August
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3\. U.S. Food and Drug Administration, Memorandum of Site Visit, August
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4\. U.S. Food and Drug Administration, Memorandum of Site Visit,
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5\. U.S. Food and Drug Administration, Memorandum of Site Visit,
September 21, 1999, to Shaklee Manufacturing Center, Norman, OK.
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Food Safety and Applied Nutrition.

6\. U.S. Food and Drug Administration, Memorandum of Site Visit,
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