1. © 2015 Bergeson & Campbell, P.C. All Rights Reserved. James V. Aidala Bergeson & Campbell, P.C. Washington, D.C. www.lawbc.com © 2015 Bergeson & Campbell, P.C. All Rights Reserved. Delta Council Farm Policy Committee Meeting Stoneville, Mississippi “FIFRA Sufficiency” November 6, 2015

2. © 2015 Bergeson & Campbell, P.C. All Rights Reserved. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Has a Very Long History  Legislation in 1910, 1947, 1972, 1978, 1988, 1996  Last major legislation was Food Quality Protection Act (FQPA) in 1996  No serious discussion of amendment in many years  Each of these cycles responded to public concerns to toughen the standards for approval

3. © 2015 Bergeson & Campbell, PC. All Rights Reserved. What Does EPA Approval Mean?  Under FIFRA:  “no unreasonable adverse effects” when used according to the label Taking into account benefits  Under the Federal Food, Drug, and Cosmetic Act (FFDCA):  “reasonable certainty of no harm” from exposure to residues in food ‒ Includes aggregate, 10x safety factor, etc. ‒ “No benefits” considerations 3

4. © 2015 Bergeson & Campbell, PC. All Rights Reserved. How Much Does It Cost?  Costs to Registrants  $150-$250 million from discovery to market (research and development (R&D), capital plant)  Data costs for specific product: $20- $30 million Additional costs for global registrations 4

5. © 2015 Bergeson & Campbell, PC. All Rights Reserved. How Extensive Is U.S. Environmental Protection Agency (EPA) Review?  EPA Cost  Estimated internal EPA cost for new molecule review: $2 million (includes industry PRIA fee >$600 thousand) Approximately 14-15 person years of work  Program Budget (Fiscal Year (FY) 2015)  FY 2015 Appropriations $120 million + fees = $162 million  Supports approximately 600 full time employees (FTE ) 5

6. © 2015 Bergeson & Campbell, PC. All Rights Reserved. EPA Review  EPA uses very conservative assumptions  Examples:  Olympic swimmers training in pool 5+ hours/day  Children petting dogs with flea products applied (how long, how much, etc.)  Children/adults rolling on residential lawns, hand to mouth exposures, residues on carpet  99.9 percentile for pesticide residue exposure in food  Food Quality Protection Act (FQPA) added “extra 10x” safety factor for kids and pesticide food residues EPA now adding “FIFRA” 10x for occupational risks 6

7. © 2015 Bergeson & Campbell, P.C. All Rights Reserved. So, What Does EPA Approval Mean?  It means an approval based on extensive data, generated at great cost, with an exhaustive government review using very conservative assumptions applying the toughest standards of any environmental law in the U.S.  Note: Pesticide approvals are the most exhaustive review of any material allowed in the U.S. Drug approvals do not receive ecological impact review  How can the agricultural community get that message across?

8. © 2015 Bergeson & Campbell, PC. All Rights Reserved. Issue: Pesticide Approvals Constantly under Challenge  Routine criticism; often centering on the “chemical of the month”  Critics finding new approaches to challenge approvals (Endangered Species Act (ESA), Clean Water Act (CWA))  “Europe” standards are “better” with precautionary approach  State and local governments second-guessing EPA  General public distrust of institutions: “Washington,” “Government,” “Big Agriculture,” “Chemical Companies,” “Them” 8

9. © 2015 Bergeson & Campbell, PC. All Rights Reserved. Why Does EPA Not Defend Its Work?  Answer: “Not my job to defend your chemical”  Real question:  Why does EPA not defend its regulatory decisions? 9

10. © 2015 Bergeson & Campbell, PC. All Rights Reserved. Pesticide Industry Narrative Is a Good One  Over decades, industry has responded to regulatory concerns  More extensive data  Lower impact materials  Lower volume use rates  Exposure reduction technologies  Overall: Regulatory standards have changed; requirements are more stringent -- industry innovation has responded to public concerns and regulatory directions  Observation: Products introduced over the last 20+ years have not been subject to controversies over human health concerns 10

11. © 2015 Bergeson & Campbell, PC. All Rights Reserved. What Can Be Done?  Communicate?  Activate?  Motivate? 11

12. © 2015 Bergeson & Campbell, P.C. All Rights Reserved. Communicate?  Answer pesticide critics so that with an EPA approval growers and registrants can enjoy greater business certainty  How to tell story of rigorous oversight and regulation, and  Are there deficiencies in what EPA does (if so, what is response)?  Example: Tailor responses to state and local regulation  Involve EPA in explaining/defending its decisions  Involve users to explain need for and precautions taken when using products

13. © 2015 Bergeson & Campbell, PC. All Rights Reserved. Activate?  Re-energize “traditional” agriculture coalition – growers, food producers, registrants, farm advocates  CropLife outreach to grower groups as part of Pesticide Policy Coalition (PPC)  CropLife Local Issues Team created to help outreach and awareness of both industry and the public  What has worked; lessons learned/effective messages  Ongoing process; where to next?  How to involve/activate allies (traditional agricultural coalition) 13

14. © 2015 Bergeson & Campbell, PC. All Rights Reserved. Activate? (cont’d)  Involve Capitol Hill as a bully pulpit  Educate new members  Possible hearings to examine information evaluated and “what approval means”  Get EPA on record defending decisions; that record can help in other forums (state, local)  Push/Pull of Re-Energized Agricultural Coalition  Longer term strategy for Hill involvement to get and keep Members interested  Keep agricultural allies informed and involved Easier with modern communication, social media tools? 14

15. © 2015 Bergeson & Campbell, PC. All Rights Reserved. Motivate?  How can companies engage and empower allies to communicate this information and tell this story?  What information will most resonate with (1) members of the agriculture family and (2) the public?  What networks or other existing organizations can be tapped into to get this information more widely circulated?  What interaction with EPA might help meet these goals (growers, extension, state lead agencies?) 15

16. © 2015 Bergeson & Campbell, PC. All Rights Reserved. Outlook  Litigation and court decisions driving outcomes/second-guessing EPA decisions  Pollinators – example: Sulfoxaflor  Endangered Species Act – example: Enlist, Cyantraniliprole  Net result: new product approvals will be slowed and may be stopped  2016 is last year of Obama Administration  “legacy issues” Environmental justice Tougher standards - example: Chlorpyrifos Worker protection, bystander risk, bees, surface water  November 2016 Presidential Election  If Democrats win – more of the same?  If Republicans win – more litigation, more “investigations”?  What will agenda be for Congress in 2017? 16

17. © 2015 Bergeson & Campbell, PC. All Rights Reserved. Thank You James V. Aidala Bergeson & Campbell, P.C. 2200 Pennsylvania Avenue, N.W. Suite 100W Washington, D.C. 20037 jaidala@lawbc.com www.lawbc.com 17