Wiley has extensive experience in providing compliance assistance to clients across the entire spectrum of federal and state laws governing the manufacture, distribution, and sale of consumer products. We have particular expertise in regulatory compliance matters arising under federal laws administered by the U.S. Environmental Protection Agency (EPA), U.S. Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS), U.S. Customs and Border Protection (CBP), Consumer Product Safety Commission (CPSC), U.S. Department of Transportation (DOT), the Federal Aviation Administration (FAA), U.S. Department of Energy (DOE), and the Federal Trade Commission (FTC). We also provide strategic advice in regulatory compliance issues arising at the state level (including California’s Proposition 65 and various recycling laws for electronics and batteries).
With respect to compliance assurance, we conduct compliance audits and assist clients with internal evaluations to spot and correct compliance problems before they are discovered by regulatory authorities. We support clients in conducting post-inspection compliance evaluations and root cause analyses, and assist with identifying appropriate corrective actions. We are known for our practical expertise in helping clients implement corrective actions through developing and refining SOPs, and designing training programs to prevent future compliance failures.
In addition, we have over 35 years of collective experience representing clients in enforcement matters before federal and state agencies involved in the regulation of consumer products such as pesticides, chemicals, electronics, industrial equipment, food, batteries, and other household products. We routinely assist clients in responding to requests for information, notices of violation, and stop sale orders, and we negotiate settlement agreements and consent orders under various enforcement programs involving compliance with the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Toxic Substances Control Act (TSCA), the Federal Food, Drug, and Cosmetic Act (FFDCA), the Resource Conservation and Recovery Act (RCRA), the Clean Air Act (CAA), the Hazardous Materials Transportation Act (HMTA), the Pension Protection Act (PPA), and various Customs’ laws and regulations relating to export controls.
- Serving as on-site regulatory compliance officer for major pesticide manufacturer during conduct of a wide-ranging internal compliance review and corrective action program involving several environmental statutes.
- Assisting major consumer products company with root cause investigation and compliance review arising from several recalls involving pet food.
- Assisting chemical company in designing new compliance programs for chemical exports.
- Developing training programs for pesticide manufacturer for compliance with FIFRA.
- Negotiating the successful settlement of a federal-level EPA enforcement action against a company for numerous violations of FIFRA.
- Negotiating the successful settlement of an FAA enforcement action involving alleged violations of air transport restrictions for hazardous materials.
- 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
- Toxic Substances Control Act (TSCA)
- Transactions, Due Diligence and Supply Chain
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- Press ReleaseRyan Michael Fournier and Bob Hibbert Join Wiley, Further Bolstering FDA Regulatory PracticeOctober 1, 2020Ryan Michael Fournier, Bob Hibbert, Ann M. Begley, Gary Yingling
- Media MentionErik Baptist Discusses EPA’s Critical Use Exemption Process Under TSCAChemical WatchAugust 3, 2020Erik C. Baptist