FIFRA: Finding a Balance between the Incentive to Innovate with Research and Development Costs
Overview:The Federal Insecticide Fungicide and Rodenticide Act ("FIFRA") governs the regulation, sale, distribution, and use of pesticides in the United States. Under FIFRA, to register a pesticide the U. S. Environmental Protection Agency (“EPA”) must determine that the pesticide will perform its intended function without harm to human health or unreasonable adverse effects on the environment. The EPA relies on third party-produced studies, tests, and other data to make such decisions. To balance the incentives to conduct R&D for new, improved pesticides with entry considerations, a company seeking a new registration may cite data (via a cite-all or a selective citation method) that appear in the public literature and/or were previously submitted to the EPA by an original data submitter. FIFRA requires that if a prospective registrant relies on an original submitter’s data in support of a pesticide registration, the prospective registrant offer to compensate to the original data submitter based on a 15 year compensability period. If the parties are unable to reach a voluntary agreement as to the amount of compensation owed, a binding arbitration under the procedures of the Federal Mediation and Conciliation Service may be initiated by either party to resolve the dispute.
FIFRA does not explicitly define compensable “costs” nor does it provide a standard formula for determining the compensation a prospective registrant should pay for citing to or relying upon data generated by another entity in support of its application. Prior FIFRA arbitrations only provide guidance as to how some arbitrators have resolved the issue of cost sharing in a given data compensation dispute and do not serve as binding precedents. Given the nature of the pesticide regulatory process and FIFRA arbitrations, the unique facts and complex circumstances of each case are critical in determining the relevant components of the compensation award. One must carefully craft developing accurate and defensible data compensation claims under FIFRA. LIVE webcast, a panel of distinguished professionals will help you understand the most critical issues which will include:
- Determining the most reliable, comprehensive, and contemporaneous business records to use in
measuring the costs of generating a pesticide
- Overcoming hurdles of limited or incomplete records
- Assess the appropriate adjustments allowed under FIFRA Timing issues
- Allocating costs between parties
- Live interactive Q&A session
The Knowledge Group is producing a LIVE webcast that will provide professionals with interest in research and development, environmental regulation, and law with a comprehensive overview of FIFRA data compensation and a keen understanding of its economic intent. This webcast will also discuss other arenas in which lawmakers and industry participants are faced with the same challenges of balancing innovation and R&D expenditures (i.e. pharma). Register now by clicking the “Register“ button below. Advanced registration is recommended as enrolment is limited for this course.
- Methodology/Theory for Preparing a Defensible Data Compensation Claim
- Historical Cost Approach
- Incremental Cost Approach
- Data Sources to Support Relevant Costs
- External Invoiced Cost Documentation
- Internal Cost Documentation
- Contemporaneous Business Documentation
- Determining Relevant Costs for Compensation
- Allocation of Costs
- Estimation of Costs
- Applicability of Adjustments
Who Should Attend:
- Senior Executives
- Operations Executives
- Legal Executives
- Administration Executives
- Manufacturing Executives
- Companies affected by FIFRA Compliance Issues
Stefanie M. Perrella is an economist in the Intellectual Property and Transfer Pricing Practice at NERA Economic Consulting in Washington, DC, a global company focused on applying economic, financial, and quantitative analyses in business, legal, and public policy contexts. She has extensive experience analyzing economic issues related to pricing, valuation, competition, innovation, and regulation in industries such as agricultural chemicals. Ms. Perrella has acted as a consulting economist in multiple FIFRA arbitrations. Additionally, she co-authored numerous valuation studies for tax, litigation, and business planning purposes and is experienced in valuing tangible and intangible property and preparing damage calculations across a variety of industries including pharmaceuticals, agricultural chemicals, and automobiles. In her work, she has used accounting, financial, statistical, and econometric analyses in various business contexts (e.g., transfer pricing, sale or acquisition of intangible and tangible property, compliance with regulations, and strategic analyses) for companies. She also works on liability, damages, injunction, and other economic issues across industries in licensing/contract, antitrust, patent, and tax disputes. She is currently engaged in preparing a public policy study spanning issues such as valuation, regulation and innovation. She received B.S. degree (summa cum laude) in International Affairs with a concentration in Finance and M.A. degree in International Economic Relations from American University.
Stefanie M. Perrella is an economist in the Intellectual Property and Transfer Pricing Practice at NERA Economic Consulting in Washington, …
Mr. Naidu has extensive transactional, litigation and regulatory compliance experience involving a diverse set of environmental areas including CERCLA, FIFRA, brownfield redevelopment, eminent domain, natural resource damages, Clean Water Act, Clean Air Act, TSCA, OSHA, RCRA, oil spills and nanotechnology. He also advises clients on federal and state statutes and environmental, health and safety regulations.
He has written several articles on these subjects, including a treatise published by the Oxford University Press entitled Biotechnology & Nanotechnology Regulation Under Environmental, Health, and Safety Laws (2009). His articles on nanomaterials have been published in Chemical Week and Industry Week.
Mr. Naidu has extensive transactional, litigation and regulatory compliance experience involving a diverse set of environmental areas including CERCLA, FIFRA, …
Roger Martella is a partner in the Environmental Practice Group at Sidley Austin LLP. He recently rejoined Sidley Austin LLP after serving as the General Counsel of the United States Environmental Protection Agency, concluding 10 years of litigating and handling complex environmental and natural resource matters at the Department of Justice and EPA.
Mr. Martella was unanimously confirmed by the United States Senate as EPA General Counsel. In that role, Mr. Martella served as EPA’s chief legal advisor supervising an office of 350 attorneys and staff in Washington and 10 regional offices. In particular, Mr. Martella lead the team responsible for developing for the first time under the Clean Air Act the federal government’s climate change legal framework and options in response to the landmark Supreme Court decision Massachusetts v. EPA, which held greenhouse gases to be air pollutants under the Clean Air Act. His efforts included developing a full range of legal options for decision makers related to greenhouse gas regulation, alternative and renewable fuels, the development of regulatory carbon sequestration controls, and the intersection of climate change and natural resource issues including the National Environmental Policy Act and the Endangered Species Act. Recognized for his knowledge on legal approaches to addressing climate change, Mr. Martella focuses specifically on dissecting the extraordinarily complex and interrelated ramifications of climate change on numerous provisions of the Clean Air Act relating to mobile and stationary sources, as well as other laws, such as the ESA and NEPA. Mr. Martella’s experience in this area enables him to work to forecast for clients the likelihood of upcoming regulations and controls in the area of climate change, clean energy, and sustainability, and to develop strategic approaches to be best prepared for such controls. Mr. Martella also focuses on international climate issues, working with Chinese institutes on climate and clean energy issues and advocating for conformity between United States climate rules with the European Union. Since the April 2007 Massachusetts decision, Mr. Martella has been invited to address climate change regulation more than twenty five times in the United States and abroad.
Roger Martella is a partner in the Environmental Practice Group at Sidley Austin LLP. He recently rejoined Sidley Austin LLP …
Claudia O’Brien is a partner in the Washington, D.C. Office of Latham & Watkins and co-chair of the Firm’s Global Climate Change Practice Group. Her practice is focused on climate change and emerging trends in air quality control, risk policy and pesticide and toxic substances. Ms. O’Brien represents companies and industry groups in petitions, agency rulemaking and litigation under federal and state environmental statutes.
Ms. O’Brien joined the firm after six years at the Environmental Protection Agency, where she worked on water, air, and toxic substance issues, including drafting regulations to implement the Clean Air Act’s first national cap-and-trade program, to address acid rain emissions from power plants. While working full time at EPA, Ms. O’Brien attended law school at Georgetown, where she received her JD in 1994. She received her B.A. from Yale University in 1987. She is admitted to the bars of Virginia, the District of Columbia, the Third, Fourth, Sixth, Seventh, Ninth and D.C. Circuits and the US Supreme Court.
Claudia O’Brien is a partner in the Washington, D.C. Office of Latham & Watkins and co-chair of the Firm’s Global …
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