FIFRA

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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
Recording Fee: $299 (Please click here for details)
NASBA Sponsor Number: 109004

 

Featured Speakers for FIFRA: Finding a Balance between the Incentive to Innovate with Research and Development Costs LIVE Webcast:


Proposed Agenda (click here to view more)
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




NERA Economic Consulting
Stefanie Perrella
Senior Analyst
speaker bio »»

K&L Gates LLP
B. David Naidu
Partner
speaker bio »»

Sidley Austin LLP
Roger R. Martella, Jr.
Partner
speaker bio »»

Latham & Watkins LLP
Claudia M. O'Brien
Partner
speaker bio »»

Who Should Attend?

- Senior Executives
- Operations Executives
- Legal Executives
- Administration Executives
- Manufacturing Executives
- Companies affected by FIFRA Compliance Issues

Why Attend?

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

Registration Information:                                                                                                                                    


 

 

 

 


FIFRA: Finding a Balance between the Incentive to Innovate with Research and Development Costs
LIVE Webcast

Speaker Firms:







 

Media Partners:



Environment News Service publishes late breaking environmental news gathered from a network of correspondents from around the world. The ENS newsfeed is available free to individuals and website owners at http://www.ens-newswire.com




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Pesticide & Toxic Chemical News is the leading source of news and analysis in relation to U.S. pesticide policy and regulation. For more than 35 years, Pesticide & Toxic Chemical News has provided its readers with critical information regarding regulatory, legislative, legal and scientific developments. Subscribers include regulators, executives, attorneys, environmental advocates and many other industry professionals, both in the U.S. and abroad. PTCN is published weekly, online and in print, with daily online news, and a searchable online archive. For more information, go to www.pesticideandtoxicchemicalnews.com.






 

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We are an approved multi-event sponsor in the state of California. Our provider ID is: 14451. In Texas, Illinois, and Virginia, we submit programs for individual approval in advance. In all other states, once attendance is verified, participants are emailed an official certificate of attendance which they submit to their respective State Bar Associations. Our programs are created with continuing education in mind and are therefore designed to meet the requirements of all State Bar Associations. If you have any questions, please email our CLE coordinator at: info@knowledgecongress.org

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.

Attention New York Attorneys:

This program is approved for CLE credit under New York’s Approved Jurisdiction policy. The Knowledge Group, LLC is an approved sponsor in the state of California, a New York Approved Jurisdiction. This program fulfills the non-traditional format requirement of exceeding 60 minutes in length. Please note only experienced attorneys (more than 2 years) are eligible to receive CLE credit via non-traditional format learning platforms. The Knowledge Group will verify attendance during the webcast via secret words (3 per credit hour) and by auditing attendees log in and log out records. All verification instructions will be provided during the webcast. Once attendance verification requirements have been completed, the attendee will be issued a certificate of attendance be The Knowledge Group for the course with the recommended number of credit hours. The Certificate of Attendance is normally sent via email in 24 hours or less.

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The attorney should simply include credits earned via Knowledge Group webcasts when computing the total number of CLE credits completed, and keep the Knowledge Group Certificate of Attendance for a period of at least four (4) years in case of audit. An attorney may count towards her/his New York CLE requirement credit earned through the Approved Jurisdiction policy without notifying the CLE Board.

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