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. Our team consists of highly skilled scientific and regulatory experts with both industry and research experience and extensive state and federal regulatory and enforcement experience. We counsel our clients on regulatory issues and work closely with the U.S. Environmental Protection Agency (EPA) and state agencies on regulatory matters.
Our representation is vigorous, strategic and detail-oriented, yet cost-efficient. We work as a team to evaluate issues and protect our clients’ interests while seeking the certainty of a settlement. Our creativity and staunch advocacy, combined with our understanding of the business context in which data compensation disputes occur, set us apart from our competitors and enable us to obtain favorable outcomes for our clients.
We represent clients across the entire breadth of the pesticide arena, including agricultural chemicals, structural and residential pesticides and biocides. Our practice covers every step of the regulatory process. We develop and submit 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. We work closely with clients to draft and produce pesticide product labels ensuring that final printed labeling is compliant with regulations. We also prepare amendments, notifications and other actions needed to maintain and expand registrations. Also, we obtain tolerances or exemptions from tolerances.
Entry into the U.S. Market
We assist 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, our 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.
We have counseled companies based throughout the world regarding the importation and sale of pesticides in the U.S., and we have 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. Our experienced staff scientists work with clients to develop the necessary data, complete the applications required by state and federal authorities, and help to create labels that will be approved by the regulatory agencies. We 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, we provide analysis of data valuation. We also 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). We 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).
We are experienced in assisting in the representation 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 and supervised audit of pesticide compliance for 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