Pesticide Regulatory Consultation
EnviroReg LLCSM is a pesticide regulatory practice that advises U.S. and global pesticide companies on state and federal regulatory, transactional, litigation and enforcement matters. Clients are counseled on regulatory issues related to Federal Insecticide, Fungicide and Rodenticide Act [FIFRA], and work closely with the U.S. Environmental Protection Agency (EPA) and state agencies on regulatory matters.
Telisport Putsavage bring decades of experience in the regulations of chemicals and the pest control industry, as well as years of navigating Federal and state pesticide regulations and labeling requirements. In addition to his years of private practice, Mr. Putsavage has also served as an Assistant Counsel with the New York State Department of Environmental Conservation and an Assistant Attorney General with the Maryland Department of the Environment.
His real-world experience from different industries enables him to bring a holistic perspective to client representation. His dedication to the interests of the clients is reflected in the loyalty of clients, many of whom have been represented for years.
Enviroreg’s representation is vigorous, strategic and detail-oriented, yet cost-efficient. Staunch advocacy, combined with our understanding of the business context in which regulatory issues arise, sets Enviroreg apart from competitors and facilitates obtaining favorable outcomes for clients.
Enviroreg represent clients across the entire breadth of the pesticide arena, including registrants of agricultural chemicals, structural and residential pesticides, and biocides and, distributors of minimum risk pesticides. The practice covers every step of the regulatory process, including developing and submitting registration applications to the necessary regulatory authorities, including managing all laboratory studies. This experience includes developing study protocols, placing and monitoring studies required by the EPA Office of Pesticide Programs for registration of technical and end-use products.
Entry into the U.S. Market
Enviroreg assists companies seeking to enter the U.S. crop protection, biocides, and biopesticide markets. Most agricultural pesticides are produced outside of and imported to the United States. By providing competition in the marketplace, Enviroreg’s generic producer clients help distributors and farmers obtain high-quality products at a competitive price to produce and protect the foods that Americans consume and export.
Enviroreg has assisted companies based throughout the world regarding the importation and sale of pesticides in the U.S., and has worked with many companies from their nascent interest in the U.S. market through the successful entry, overcoming difficult barriers to entry imposed by the dominant economic interests. Enviroreg represented the first Indian company and the first Taiwanese company to enter the U.S. market by obtaining registrations for technical-grade generic pesticides.
To assist prospective entrants in assessing market viability of proposed technical registration, Enviroreg can provide analysis of data valuation and help registrants in evaluating claims made by data owners following securing of registration. EnviroReg is experienced in assisting pesticide manufacturers in data compensation negotiations under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). Enviroreg can provide analyses of the amount of data compensation a prospective new entrant may expect to pay to data owners, including to multi-company Task Forces, and assist registrants in assessing compensation claims made by data owners.
In data compensation matters, we work closely with Telisport Putsavage of the law firm Putsavage PLLC, who has extensive experience with FIFRA data compensation negotiations and arbitration proceedings before the American Arbitration Association (AAA).
Enviroreg is experienced in assisting in the representation of pesticide registrants and other market participants in state and federal enforcement actions. Cooperating with Putsavage PLLC, we have assisted with the defense of clients whose products have been alleged to lack registration or to be misbranded or adulterated, and have contributed in securing beneficial settlements in cases where enforcement authorities have sought significant penalties. We also have experience in assisting with the implementation of post-settlement compliance actions, including pesticide registration and label audits.
Representative Client Work
- Represented multiple generic agricultural chemical companies entering the U.S. market, including the first Indian company to be awarded a technical registration by the U.S. EPA
- Secured the first U.S. generic technical registration of paraquat herbicide
- Prevailed before the EPA Human Studies Review Board in a challenge to EPA’s proposed use of historic data from an outmoded clinical drug trial
- Assisted counsel in assessing data in multi-million dollar negotiations and arbitrations addressing the compensation due to reliance upon pesticide data previously filed with EPA
- Designed, executed, and supervised an audit for pesticide compliance for a client holding more than 100 pesticide registrations
- Obtained for clients the first registrations of insect-repellent fabric for use in commercially-available outdoor activity apparel and insect-controlling fabric for use in bedding
- Prepare and submit state registration applications and renewals