Regulatory policies, development

The purpose of this document is to articulate the FDA s policy on development and use of standards with respect to international harmonization of regulatory requirements and guidelines. As used throughout this document, the term standards includes what are commonly referred to as consensus standards, voluntary standards, and industry standards. Also, the FDA sometimes accepts standards and makes them mandatory regulatory requirements. Although the draft policy focuses on international harmonization and international standards, its principles are applicable as well to domestic standards activities in which the FDA participates. 

The government s major direct and Indirect role In the creation and deployment of the nation s technical resources needs to be fully recognized as future Federal policies are developed. In particular. It Is difficult to overstate the Importance of developing economic and regulatory policies which will significantly restlmulate the private sector s Involvement and Investment In technology development and commercialization. 

Individual volumes published in the series span the wide spectrum between research, development and practice in the topic of freshwater and related areas such as gender and social aspects as well as policy, regulatory, legal and economic aspects of water. The series covers all fields and facets in optimal approaches to the ... 

Regulatory policies are often developed in response to problems. 

Worlds apart are the practices, yet the official policies and regulatory guidelines in developing countries show much influence from those of the developed world. While waste import bans are common in the developing world, the topography of recycling and disposal costs seems to assure a flow of e-waste out of the developed world down to the points of lowest-cost disposal. 

Under the new administration, this section of TSCA has come under the scrutiny of Vice President Bush s task force on regulatory relief and the Office of Toxic Substances is placing a high priority on efforts to develop more cost-effective means for achieving industry compliance with OTS policies. In addition to fostering voluntary actions by industry wherever possible in lieu of formal rules, these effects include elimination of unnecessary burdens on industry in complying with mandated TSCA requirements. 

A large part of the difficulty in developing regulatory initiatives under TSCA may be the lack of specific statutory direction. Preventing unreasonable risks is harder to implement as a policy than achieving percentage reductions in air emissions of particular pollutants. The implementation of this Act has therefore tended to focus on information-gathering objectives rather than control activities. 

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