- Commercial Chemicals and Toxic Substances Control Act (TSCA)
- Compliance and Enforcement
- Emerging Technologies
- End-of-Life Product Management
- Import, Export, and Transportation
- Manufacturing and Materials Restrictions
- Pesticides and FIFRA
- Product Safety
- Product Stewardship and Recycling
- Recalls and Reverse Distribution
- Supply Chain and Transactional Support
Wiley Rein provides strategic advice to clients involved in emerging technologies—such as synthetic biotechnology and nanotechnology—that are so new, the policy implications are still being gauged. New technologies push the fabric of society and often challenge the boundaries of health, safety, and environmental law. Wiley Rein has substantial experience in counseling clients in this complex area.
Emerging technologies are revolutionizing fields as varied as electronics, medicine, communications, agriculture, and energy. For the economic and public benefits of these advancements to become a reality, steps must be taken to ensure safety without stifling innovation, stigmatizing emerging technologies, or creating trade barriers. Wiley Rein attorneys regularly advise clients on new biotechnological techniques such as CRISPR, meganucleases, RNA interference technology, TALENs, and zinc-finger nucleases. Many of our attorneys have served within the government, implementing the complex regulatory structure applicable to genetically engineered products.
We have substantial expertise in representing stakeholders before the Coordinated Framework agencies to obtain clearances for highly regulated genetically engineered products. Under the Federal Coordinated Framework for the Regulation of Biotechnology, products developed for food use, food production, pest control, and industrial manufacturing are regulated, in varying combinations depending upon the particular use, by the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA). We are poised to represent clients in navigating the first comprehensive revisions of USDA’s regulation since 1987.
In the area of nanotechnology, Wiley Rein counsels companies on a range of legal issues involving the manufacture and use of nanomaterials in industrial, food, pesticide, and consumer applications. We routinely advise brand owners on evaluating and using nanoscale materials in consumer products including matters relating to product labeling and marketing claims. We served as a leading negotiator for U.S. interests in the development of international labeling standards for consumer products containing manufactured nanomaterials.
- Counseling clients on the separate and distinct regulatory requirements of FIFRA, TSCA, the FFDCA, and the Plant Protection Act.
- Assisting a major agribusiness company in developing a comprehensive analysis of statutory, regulatory, and common law requirements applicable to the development, sale, and distribution of genetically engineered food crops in the United States.
- Assisting numerous clients in navigating the unique regulatory requirements applicable to biopesticides—including the critical initial step of demonstrating to EPA that the substance meets the requisite criteria for classification as a biochemical pesticide.
- Representing a trade association of processors and downstream users of nanotechnology on regulatory issues with a focus on advancing U.S. manufacturing sectors.
- Advising clients on TSCA Section 8 requirements for nanomaterials on the TSCA inventory.
- Successfully negotiating with the EPA TSCA program to secure regulatory approval for the use of fullerenes, carbon nanotubes, and nanocellulose.
- Assisting companies in addressing safety and potential liability risks arising from the sale and distribution of consumer products containing nanotubes and nanosilver.
News & Insights
News & Insights
- 2015 | ArticleNavigating Legal Issues in the Biotechnology IndustryAspatore Books
- Summer 2014 | ArticleNatural Resources & Environment
- May 2014 | ArticleJ. Craig Venter Institute