Environmental Assessment
for the U.S. 

In the U.S., the following areas require an Environmental Assessment; food, human drugs and biologics, animal drugs and veterinary, and tobacco products when seeking FDA approval for sale in the U.S. Environmental Assessments are a requirement of FDA Pre-market Tobacco Applications (PMTA) and Modified Risk Tobacco Product (MRTP) submissions. 

No. In general, the absence of an Environmental Assessment or an inadequate Environmental Assessment will result in either a ‘Refuse to accept’ or a ‘Refuse to file’ decision.

Yes. Each product or stock-keeping unit (SKU) requires a separate Environmental Assessment.

An Environmental Assessment will either result in a Finding of No Significant Impact (FONSI) or, if significant environmental impacts appear likely, a Notice of Intent (NOI) to prepare an Environmental Impact Statement (EIS). An EIS is a much more comprehensive environmental assessment process and document.

The Environmental Assessment process helps regulatory agencies identify potential adverse environmental impacts that could delay or derail your project. It, therefore, supports planning and decision-making by giving insight into potential risks helping you develop effective mitigation strategies to reduce, avoid, or offset the potential adverse environmental consequences.

Environmental Assessments should be considered at all project stages, from concept, through feasibility, design and engineering, realization, and post market surveillance. However, considering the process early can result in efficiencies, especially for characterizing natural resources around U.S. based facilities and engaging with manufacturers and other vendors to understand product supply chains.

Deep understanding and previous experience with NEPA and FDA requirements are essential when choosing a consultancy to support a regulatory submission requiring an Environmental Assessment. Our team has years of combined experience in submitting Environmental Assessments for various industry sectors and learned valuable lessons along the way, including what type of information should be included in and excluded from an Environmental Assessment. Understanding such agency preferences provides a smoother pathway to regulatory approval.