FIFRA and the ESA: Reconciling the Differences

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1 FIFRA and the ESA: Reconciling the Differences Jason C. Rylander Senior Staff Attorney, Defenders of Wildlife

2 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.

3 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.

4 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)

5 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.

6 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

7 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.

8 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

9 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.

10 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.

11 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)

12 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!

13 ESA Key Concept: Insure Against Jeopardy 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. FIFRA Key Concept: Unreasonable adverse effect 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).

14 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 Interagency conflict stalls progress Lack of resources

15 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.

16 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

17 Cyantraniloprole Feb. 29, EPA announced receipt of application June 6, EPA states intent to register ingredient Jan. 24, 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.

18 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?

19 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?

20 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?

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