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Under NLEA, the Secretary is bound by a strict timetable to disseminate the results of the study and propose changes in the Federal requirements, as appropriate. The focus of the Committee's work thus was outlined within the specific language of NLEA.

One of the Committee's tasks was to establish a definition for adequate implementation as a basis for judging current Federal requirements. The Committee began with the NLEA statutory language and examined the Congressional Record on the subject. This inquiry revealed that the debate in both chambers primarily centered on sections other than the provision mandating this study. However, in summarizing the requirements of NLEA for the full House, Representative Henry A. Waxman (D-Calif.) made the following statements:

Section 6(b)(1) requires the Secretary to enter into a contract for a study of State and local laws of the type that will be preempted by Section 403(a)(3), and of the relevant federal laws and regulations. The purpose of this study is to provide the Secretary information upon which to determine whether federal laws are adequate once the State laws are preempted [emphasis added]. It is anticipated that the study will identify an federal regulations that are applicable as well as State laws that will be preempted. The study should also survey local laws, but it is not anticipated that every local law will need to be identified (U.S. Congress, 1990).

This language emphasized in particular that Congress expected the Committee to go beyond merely determining the existence of a Federal regulation. Rather, it was to decide, once State requirements were preempted, whether the remaining Federal statutes and regulations were adequate for the protection of the public.

The Committee also sought guidance from persons who participated directly in the development of NLEA Section 6(b). William Schultz, Counsel to the House Subcommittee on Health and the Environment, and Peter Barton Hutt, Partner in the law firm of Covington and Burling, met with the Committee on separate occasions to share their recollections of the Congressional discussions of the definition of "adequate implementation" and the Committee's charge. As a result of these discussions, the Committee learned the following regarding the development of Section 6:

  • There was no attempt on the part of Congress specifically to define adequate implementation; the final determination was left to those who would conduct the study as pan of their recommendations to the Secretary.

  • The expectation of Congress was that the adequacy of the Food and Drug Administration's (FDA) implementation was to be determined by

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