With under a week remaining for drug producers to comply with the first stages of Washington State’s King County drug take-back and disposal program, industry and regulators alike are watching closely. As one of two first-in-the nation programs requiring drug manufacturers to bear the costs of organizing and implementing a drug take-back and disposal program for county residents, the program’s success may inspire wider adoption of laws requiring manufacturers to address end-of-life management for products. Following a Ninth Circuit decision upholding a California county’s similar program and the promulgation of the Drug Enforcement Agency’s final rule authorizing the return of controlled substances, pharmaceutical manufacturers must now register in both California and Washington counties or face civil penalties of up to $1,000 or $2,000 dollars per day, respectively.

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Photo of Warren Lehrenbaum Warren Lehrenbaum

Warren Lehrenbaum represents individual companies and trade associations before the U.S. Environmental Protection Agency (EPA), the United States Department of Agriculture (USDA) and the Food and Drug Administration (FDA), where he advocates on behalf of individual products as well as broad policy issues.

Warren Lehrenbaum represents individual companies and trade associations before the U.S. Environmental Protection Agency (EPA), the United States Department of Agriculture (USDA) and the Food and Drug Administration (FDA), where he advocates on behalf of individual products as well as broad policy issues.

Warren serves as a member on the firm’s Environment and Natural Resources Group Steering Committee. His practice focuses on chemical regulation and biotechnology issues arising under the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), the Food Quality Protection Act (FQPA), the Federal Food, Drugs and Cosmetics Act (FFDCA), the Emergency Planning and Community Right-to-Know Act (EPCRA), and related State and Federal laws. He assists large and small companies in the chemical and biotechnology fields obtain regulatory approvals for their products, and he helps clients address ongoing compliance and product stewardship issues. Warren’s counseling in these areas typically involves issues such as: assisting manufacturers of chemical or biotechnology products understand their registration, premarket notification, testing and reporting obligations, and assisting manufacturers of crop protection products in protecting their data compensation rights. He also assists companies in their day-to-day compliance with pollution control obligations under the Clean Water Act, the Resource Conservation and Recovery Act (RCRA) and other statutes.

A substantial portion of Warren’s practice is devoted to helping clients develop and implement corporate compliance programs, including environmental auditing programs and comprehensive environmental management systems. He also assists clients in identifying instances of potential non-compliance and defending against administrative investigations and enforcement actions. Warren has negotiated successful settlements in numerous enforcement cases, often involving complex supplemental enforcement projects (SEPs) and challenging economic benefit and BEN model issues.