Wiley 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 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 attorneys regularly advise clients on new biotechnological techniques such as CRISPR, meganucleases, RNA interference technology, TALENs, and zinc-finger nucleases.
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 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.
With respect to the emerging agricultural technologies of biopesticides and biostimulants, Wiley boasts unique experience in the legal and policy underpinnings of the evolving regulatory scheme applicable to these products. Wiley has a former Director of EPA’s Biopesticides and Pollution Prevention Division who previously had been chief legal counsel to BPPD while an attorney with EPA’s Office of General Counsel. Thus, we have broad expertise in all aspects of pesticides regulation applicable to biopesticides and biostimulants. Wiley also provides patent counseling and services to pesticide companies throughout the entire life cycle of product development, i.e., from first ideation to commercial development and beyond.
In addition to intellectual property, regulatory, and administrative law counseling, we regularly assist companies with understanding complex requirements and potential pitfalls relative to product labeling, marketing, and advertising requirements; copyright and trademark issues, and import, export, and rules and regulations applicable to U.S. transport of pesticide materials.
- 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.
- 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.
- Climate Change
- Compliance and Enforcement
- Emerging Technologies
- End-of-Life Product Management
- Endangered Species
- Energy Efficiency
- Environmental Regulation, Litigation, and Counseling
- Hazardous Materials Transportation
- Import, Export, and Transportation
- Manufacturing and Materials Restrictions
- Occupational Health and Safety
- Pesticides and FIFRA
- Product Safety
- Product Stewardship and Recycling
- Recalls and Reverse Distribution
- Supply Chain and Transactional Support
- Toxic Substances Control Act (TSCA)
Related News & Insights
- EventContinuing Evolution of the Coordinated Framework: Implications for Agricultural Biotechnology256th ACS National Meeting & ExpositionAugust 23, 2018Keith A. Matthews
- EventEPA Registration of dsRNAi Plant Incorporated Protectants: Implications for Gene Edited Products256th ACS National Meeting & ExpositionAugust 23, 2018Keith A. Matthews
- EventCommon challenges and hurdles when navigating the regulatory framework for biopesticides and biostimulants in North AmericaAgBio Innovate USAJuly 12, 2018Keith A. Matthews
- ArticleNavigating Legal Issues in the Biotechnology IndustryAspatore Books2015Martha E. Marrapese