© 2015 bergeson & campbell, p.c. all rights reserved. james v. aidala bergeson & campbell,...

© 2015 Bergeson & Campbell, P.C. All Rights Reserved.

James V. AidalaBergeson & Campbell, P.C.Washington, D.C.www.lawbc.com


Delta Council

Farm Policy Committee Meeting

Stonevil le, Mississippi

“FIFRA Suffi ciency”

November 6, 2015


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

© 2015 Bergeson & Campbell, PC. All Rights Reserved.3

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


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


How Extensive Is U.S. Environmental Protection Agency (EPA) Review?

EPA CostEstimated 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)


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


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?


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”


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?


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


What Can Be Done?

Communicate?

Activate?

Motivate?


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


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)


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?


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?)


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?


Thank You

James V. AidalaBergeson & Campbell, P.C.

2200 Pennsylvania Avenue, N.W.Suite 100W

Washington, D.C. [email protected]

www.lawbc.com

© 2015 bergeson & campbell, p.c. all rights reserved. james v. aidala bergeson & campbell,...

Documents

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pesticide approvals

epa approval mean

rodenticide act fifra

exhaustive review

drug approvals

cosmetic act ffdca

pesticide food residuesepa