FIFRA and the ESA:
Reconciling the Differences
Jason C. Rylander
Senior Staff Attorney, Defenders of Wildlife
50 Years Later – Similar Problem
1962 – Pesticides have been
approved for use “with little or
no advance investigation of
their effect on soil, water
wildlife and man himself ”
Today – 1,100 pesticide active
ingredients (20,000 distinct
formulas) registered under
FIFRA.
• Less than 3 dozen (< 4%)
have been screened under the
ESA for impacts to wildlife.
Endangered Species Act (ESA)
Purpose: to “provide a means whereby the ecosystems upon
which endangered and threatened species depend may be conserved.”
16 U.S.C. § 1531(b)
“Congress has spoken in the plainest of terms, making it abundantly
clear that the balance has been struck in favor of affording
endangered species the highest of priorities, thereby adopting a
policy which it described as ‘institutionalized caution.’”
TVA v. Hill, 437 U.S. at 194.
Section 7 Consultation – The “Heart of the ESA”
• Section 7(a)(1) – Federal agencies have
a duty to “utilize their authorities in
furtherance of this chapter by carrying
out programs for the conservation of
endangered species and threatened
species.” 16 U.S.C. § 1536(a)(1)
• Section 7(a)(2) – “Each federal agency
shall … insure that any action
authorized, funded, or carried out by
such agency … is not likely to jeopardize
the continued existence of any endangered
species or threatened species or result in the
destruction or adverse modification of
habitat of [critical habitat].” 16 U.S.C. §
1536(a)(2)
ESA Adds Layer of Protection
• Section 7 requires species
protection when agency takes
or authorizes an action
• Measures to protect species
may go above and beyond
the underlying statute
• Registration and use of
pesticides should be no
different than discharge of
pollutants (CWA and CAA)
or logging (NFMA) or any
other federal action.
ESA Consultation Focuses on
Species in Their Habitats
• Services must consider effects of
the action in context:
 Species’ current status
 Status of habitat, and
 Other ongoing and proposed
actions affecting species
• Determine the effects to species “in the wild”
• Using the “best available science”
Federal Insecticide Fungicide and
Rodenticide Act (FIFRA)
• FIFRA regulates pesticides by
registering active ingredients for
specific uses.
• Registration results in EPA
approval of a label, which
functions as an enforceable
federal “permit,” detailing the
approved use and any
constraints to prevent harm to
environment and human health.
Key Points About FIFRA Registration
• Registration standard: “not generally cause unreasonable
adverse effects on the environment.” 7 U.S.C. 136a(c)(5)
• EPA uses a risk-benefit analysis that allows harmful
pesticides to be registered if their economic benefit
outweighs the environmental harms.
• Relies on manufacturers: Application must include
information on chemical composition, modes of action,
proposed uses, and potential harm to humans and the
environment.
• EPA’s Ecological Risk Assessment: Focuses on effects
to wildlife generally of active ingredient; it is not species
or site-specific
FIFRA: Post-Registration
• EPA has ongoing duty to review registrations and respond to
information about pesticide effects. 7 U.S.C. 136d(a)(2)
• Re-registration review (generally every 15 years)
• Cancellation: EPA may seek cancellation if “a pesticide or its
labeling or other material required to be submitted does not
comply with the provisions of this Act or, when used in
accordance with widespread and commonly recognized practice,
generally causes unreasonable adverse effects on the
environment.”
• Suspension: to prevent an “imminent hazard” during time
required for cancellation process – much higher standard than for
registration in first instance.
EPA Risk Assessments v. ESA Consultation
• EPA Risk Assessment Process
– general inquiry looking at the
effects of an active ingredient on
broad categories of aquatic and
terrestrial species, it is not speciesor site-specific.
• Consultation Process
– looks at the current status of
specific species, considers other
stressors, and adds effects of
pesticides to that baseline to
determine effects to species in
real-world habitats.
FIFRA Risk Assessments and ESA Consultations
Address Different Factors
To make an ESA determination, Services must analyze:
• The current status of the species and other stressors
• Direct effects, including acute lethality, but also
sublethal effects on growth, reproduction, migration,
susceptibility to disease
• Indirect effects, including
effects to prey or other aspects
of habitat (e.g. herbicide effect
on plants)
FIFRA Risk Assessments and ESA Consultations
Address Different Factors (continued …)
To make an ESA determination, Services must analyze:
• Effects of all ingredients (inerts)
in formulated pesticide products, not
just active ingredients
• Additive or synergistic effects of
mixtures of more than one pesticide
occurring in species habitat
• None of these features are shared by EPA’s ecological
risk assessment process!
ESA
FIFRA
Key Concept:
“Insure Against Jeopardy”
Key Concept:
“Unreasonable adverse effect”
• The duty to “insure” that species
are not jeopardized and critical
habitat is not destroyed or
adversely modified is a high bar
that drives all aspects of
Section 7 analysis, particularly
the assessment of scientific
uncertainty.
• Avoids Type II error (too little
protection.
• Registration is based on costbenefit analysis that says little
about a pesticide’s overall safety
or its impact on specific species.
Focus is on impacts to human
health and the environment in
light of social and economic
concerns, not particular species.
• Avoids Type I error (too much
protection).
The Problem: Consultation FAIL!
• For many years, EPA refused to consult with FWS and NMFS
• EPA and Services disagree on how to properly assess risk
– EPA’s approach requires limited or no consideration of
sublethal, cumulative, and synergistic effects of pesticides.
– FWS believes these effects must be considered under the ESA.
• Backlog – FWS has 170+ pending requests for consultation.
EPA has 1,100 active ingredients scheduled for registration review
by 2022.
– Interagency conflict stalls progress
– Lack of resources
Rozol Prairie Dog Bait
• May 13, 2009, EPA registered Rozol
(chlorophacinone) for use on prairie
dogs in 10 mid-western states.
• Second Generation anti-coagulant
with strong risk of secondary
poisoning for BFFs and raptors.
• EPA provided no notice and no
opportunity for comment in violation
of FIFRA.
• EPA refused to consult, even after
FWS and WAFWA called for
registration to be rescinded.
Rozol
• Case result: Judge Ellen Huvelle (DDC)
found EPA in violation of the ESA.
• EPA and Liphatech agreed to voluntarily
rescind registration pending completion
of consultation, and amend label and
provide endangered species warnings
through BulletinsLive.
• EPA also agreed to publish notice of
receipt of applications in the Federal
Register.
• Case improved registration process but
did not lead to more consultations
Cyantraniloprole
• Feb. 29, 2012 - EPA announced receipt of application
• June 6, 2013 - EPA states intent to register ingredient
• Jan. 24, 2014 - EPA registers cyantraniloprole and 14 end use
products despite finding that “the proposed uses have the potential
for direct adverse effects to listed and non-listed mammals
(chronic), freshwater invertebrates (acute), terrestrial invertebrates,
estuarine/marine invertebrates (acute) and benthic invertebrates
(acute and chronic).” Cyan. RA at 5.
• RA concludes: Acute and chronic harm will occur for nearly all
taxonomic groups that are represented on the list of T&E species.
Id. at 149.
Cyantraniloprole
• Most pesticides are STILL registered
without consultation, or are registered
concurrent with initiation of
consultation.
• EPA’s new approach focuses on “worst
of the worst” in the reregistration
process, and skips new registrations,
but how do we know if the analysis is
never done?
• Why keep adding to the backlog?
Key Challenges to Improving Pesticide Consultation
• Policy Question – Under the ESA, what level of risk to listed
species is acceptable from the registration of a pesticide under
FIFRA?
• Science Question – what is the proper method of assessing
those risks?
• Funding Question – How will the Services and EPA address
current and future pesticide consultation workload?
• Process Question – How can the Services and EPA improve the
process of consultation so that it is more effective, efficient,
transparent, and predictable?
The Future of Consultation
The Goal: A durable, effective, and politically sustainable pesticide
consultation process that addresses concerns before registration
• Current administrative reform effort must continue
– NAS study/Interim Approaches document
– EPA and FWS must work together to address differences
• New pesticide registrations require consultation now
• Adequate resources needed to complete re-registrations
– EPA has 40 FTEs for pesticide RAs, FWS has 4, NMFS 7
– Pesticide Registration Improvement Act (PRIA) funds for
Consultation?