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Regulatory Support
Registration, Evaluation, and Authorization of Chemicals
Endocrine Disrupter Screening Program (EDSP)
Tier 1 Screening Battery (T1S) consists of a series of studies designed to detect chemicals that can interfere with hormone systems. The screening battery, which includes ecotoxicity tests with fish and amphibians, is due to be implemented shortly by the US EPA under authority granted by the Federal Food, Drug, and Cosmetic Act.
Environmental Assessments for Pharmaceuticals
U.S. Food and Drug Administration (FDA) requires that an environmental assessment accompany any New Drug Application (NDA) or Animal NDA for a drug with an expected environmental concentration greater than one part per billion (ppb), as well as those known to cause adverse ecotoxicological effects at lower concentrations.
REACH (Registration, Evaluation, and Authorization of Chemicals)
is a new European Union regulation on chemicals and their safe use. Regulation (EC) No 1907/2006 is the central act of the new European chemical substance policy and is often referred to as the "REACH Regulation."
FIFRA (Federal Insecticide, Fungicide and Rodenticide Act)
This statue regulates the registration and use of pesticides. ABC provides a variety of services designed to assist our clients in the pesticide development and registration process for new products and to maintain and defend existing products.
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