Even before a product is ready for commercial release, many regulatory requirements and non-regulatory considerations apply to its research and development. Beveridge & Diamond helps clients identify and manage these issues. For example, our attorneys have assisted product manufacturers and importers in the following areas.
- The regulatory approval pathways for nanomaterials and related product stewardship programs that identify potential risks and protect against human and environmental exposure.
- The green chemistry considerations of product development under the federal Pollution Prevention Act and state programs such as California’s Green Chemistry Initiative.
- Product eligibility under federal, state, and corporate environmentally preferred purchasing programs.
- Product-related due diligence regarding the impact of global environmental treaty requirements on potential natural product ingredients, including under the Convention on Biological Diversity and the Antarctic Treaty System.
- The regulatory aspects of research and development of bioengineered organisms under National Institutes of Health Guidelines, Environmental Protection Agency regulations under the Federal Insecticide, Fungicide, and Rodenticide Act and the Toxic Substances Control Act, and Animal and Plant Health Inspection Service regulations under the Plant Protection Act.
- The need for experimental use permits under the Federal Insecticide, Fungicide, and Rodenticide Act and assistance in obtaining them.
- Testing needed for product development under a variety of statutes and programs:
- Requirements for the humane testing of animals under the Animal Welfare Act, and protection of human participants in testing under the “Common Rule” regulations of EPA, the Food and Drug Administration, and the Department of Health and Human Services.
- The Good Laboratory Practice requirements of EPA, FDA, and their foreign counterparts.
- Reporting requirements associated with testing and other information under the Toxic Substances Control Act, the Federal Insecticide, Fungicide, and Rodenticide Act, and the Consumer Product Safety Act.
- The R&D and test marketing exemptions from premanufacture notification requirements for new chemicals under the Toxic Substances Control Act.