Delta Council
Farm Policy Committee
Meeting
Stoneville, Mississippi
“FIFRA Sufficiency”
November 6, 2015
James V. Aidala
Bergeson & Campbell, P.C.
Washington, D.C.
www.lawbc.com
© 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
© 2015 Bergeson & Campbell, P.C. 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
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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
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4
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)
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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
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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?
© 2015 Bergeson & Campbell, P.C. 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”
© 2015 Bergeson & Campbell, PC. All Rights Reserved.
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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?
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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
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What Can Be Done?

Communicate?

Activate?

Motivate?
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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
© 2015 Bergeson & Campbell, P.C. 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)
© 2015 Bergeson & Campbell, PC. All Rights Reserved.
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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?
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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?)
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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?
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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
© 2015 Bergeson & Campbell, PC. All Rights Reserved.
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