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.
Course Level: Intermediate
Prerequisite: None
Method Of Presentation: Group-Based-Internet
Developer: The Knowledge Group, LLC
Recommended CLE/CPE Hours: 1.75 - 2.0
Important Note: Your State Bar or Accounting Board will make the final determination with respect to continuing education credit. If you are applying for CLE credit in Texas you must register 20 days before the event date or you will not be able to obtain CLE credit.
Advance Preparation: Print and review course materials
Course Code:103990
Stefanie Perrella
Senior Analyst
B. David Naidu
Partner
Roger R. Martella, Jr.
Partner
Claudia M. O'Brien
Partner
SEGMENT 1:
Roger R. Martella, Jr. , Partner,
Sidley Austin LLP
- Trends in FIFRA Implementation
- EPA Review of Registrations
- Considerations in New Registrations
- Regulatory Initiatives
- Intersection with Other Laws
- Clean Water Act
- Endangered Species Act
- Enforcement Trends
- In the U.S.
- At the Border
- Beyond EPA
- Legislative revisions
- The Courts
- The ENGO Playbook
SEGMENT 2:
B. David Naidu , Partner,
K&L Gates LLP
- Use of Nanomaterials as Pesticides
- Nanosilver
- Commercial Products
- Health and Environmental Risks of Nanomaterials
- What are the differences between nanomaterials and conventionally sized materials as to risk?
- What are the problems in determining risk for nanomaterials?
- EPA Regulation of Nanomaterials under FIFRA
- Samsung Washing Machines
- EPA Region 9 Enforcement
- Petitions to EPA
- Nanomaterials as "New Pesticides" or Not
- Arguments for and against "new pesticide" designation
- Potential Avenues for Regulation
SEGMENT 3:
Claudia M. O'Brien , Partner,
Latham & Watkins LLP
- Trends in data compensation decisions in recent years
- Cost documentation:
- How much is enough?
- Creating internal systems to facilitate cost documentation
- Methods and alternatives for addressing incomplete documentation
- What should be considered in determining reasonable compensation?
- Approaches to allocation [Note: my bias is per capita]
- Accounting for the time value of money
[Note: my bias is absolutely yes, and interest is the appropriate approach]
- Should data compensation account for regulatory risks encountered by the data generator?
[Note: my bias is yes]
- Use of experts
- Regulatory experts
- Economic experts
- Avoiding pitfalls in developing and arbitrating a data compensation case
SEGMENT 4:
Stefanie Perrella , Analyst,
NERA Economic Consulting
Role of an Economist in Preparing a Data Compensation Claim:
I. Methodology/Theory for Preparing a Defensible Data Compensation Claim
A. Historical Cost Approach
B. Incremental Cost Approach
II. Data Sources to Support Relevant Costs
A. External Invoiced Cost Documentation
B. Internal Cost Documentation
C. Contemporaneous Business Documentation
III. Determining Relevant Costs for Compensation
A. Allocation of Costs
B. Estimation of Costs
IV.Applicability of Adjustments
A. Inflation
B. Interest
C. Premium
- Senior Executives
- Operations Executives
- Legal Executives
- Administration Executives
- Manufacturing Executives
- Companies affected by FIFRA Compliance Issues
This is a must-attend event for anyone interested in Federal Insecticide Fungicide and Rodenticide Act (FIFRA)
- New guidance explained by the most qualified key leaders & experts
- Hear directly from key regulators & thought leaders
- Interact directly with panel during Q&A