Endangered Species Assessments Conducted Under FIFRA: Fomesafen Registration Review Case Study

Transcription

1 Endangered Species Assessments Conducted Under FIFRA: Fomesafen Registration Review Case Study Dan Campbell, Monty Dixon, Steven Wall, Jay Overmyer Syngenta Crop Protection, LLC, Greensboro, NC

2 Topics Fomesafen key agricultural tool for the control of glyphosate resistant weeds and for use by specialty crop farmers US EPA s Registration Review Program and Endangered Species Assessment Consultations Status of the Fomesafen Case Study Conclusions and Next Steps 2

3 Fomesafen Preplant surface, preemergence and/or post emergence Cotton, dry beans, snap beans and soybeans Expansion to other specialty crops potato, tomato, peppers, others have been requested More than 50 species of broadleaf weeds, certain grassy weeds and sedges. - Strong weed resistance tool 3

4 Fomesafen: Features and Benefits Best Polyphenol oxidase (PPO) inhibitor for glyphosate-resistant weeds. - Alternative mode of action to ALS inhibitor and glyphosate herbicides Postemergence and preemergence activity Excellent crop selectivity, residual control of major weeds Low application use rates Effective in all tillage systems conventional, minimum and no-till 4

5 US EPA s Registration Review program EPA s program to assess all AI s on a rolling 15 year cycle - Required by the Food Quality Protection Act - Update all AI s with new/emerging science Will include endangered species assessments for all AI s - Consultation with National Marine Fisheries Service (NMFS) and/or Fish and Wildlife Service (FWS) for may affect determinations Two compounds are test cases for endangered species by US EPA and Services: - Fomesafen (Syngenta) - Clomazone (FMC) 5

6 EPA s Registration Review Program General Process Phase I: Docket Opening (~ 4 Mo) Preliminary Work plan Ecological Problem Formulation Define Use / Usage 60-day Public Comment Period Inputs on science, use, usage, registrations Phase II: Case Development ( yrs) Final Work plan Issue Data Call-In (if necessary) Publish Draft Risk Assessment 60-day Public Comment Period Inputs on draft risk assessment, additional data Phase III: Final Decision (~8-12 Mo) Final Risk Assessment Propose label changes / mitigations, if needed 60-day Public Comment Period Inputs on changes / mitigations, additional data Final Decision 6

7 Status of Registration Review Dockets Status of Registration Reviews registration review dockets open Final Work Plans available - 27 final decisions have been issued Mainly natural, biologicals, mineral oils, etc. Test Cases (fomesafen and clomazone) - Phase II, Case development - Draft risk assessments issued - Public comments complete 7

8 Registration Review and Consultation Under the Endangered Species Act All federal agencies must consult with NMFS and/or FWS - Activity authorized, funded or conducted which may affect listed species or designated critical habitat Roles: - Applicant (pesticide registrants) - Action Agency (US EPA, authorizing product labels) - The Services - Fish and Wildlife Service (FWS) and/or National Marine Fisheries Service (NMFS) EPA and the Services yet to agree on content, processes, and timing of consultation 8

9 Options for Consultation Timing for May Affect Determinations Phase I: Docket Opening Preliminary Work Plan; Problem Formulation Phase II: Case Development Publish Draft Risk Assessment Option A D 2 Step Process: Consult Step 1 -in Phase II when draft Informal risk assessment Consultation at issued Phase II (draft risk -assessment) Was attempted with fomesafen and clomazone Final Risk Assessment; Phase III: Final Decision Propose Decision (mitigations, if needed); Final Decision Option B D 2 Step Process: Step Consult 2 - in Phase III, final Option risk Formal C assessment Consultation and at proposed Phase III (refined Consult decision risk after Phase phase assessment, interim III, decision) after EPA issues registration review decision 9 Source EPA lays out new options for ESA consultation during pesticide registration review, Pesticide & Chemical Policy Week in review, August 5,

10 Fomesafen Registration Review Chronology Phase I: Docket Opening Action EPA Final Work Plan Estimated Date ** Actual Date Preliminary Work Plan; Problem Formulation Docket Opened Public Comments March 2007 March June /28/07 3/28/02 6/26/07 Phase II: Case Development Publish Draft Risk Assessment Phase III: Final Decision Final Risk Assessment; Propose Decision (mitigations, if needed); Final Decision 10 ** Fomesafen Final Work Plan (FWP) For Registration Review August 2007, Environmental Protection Agency, Pesticide Re-evaluation Division, Docket ID # EPA-HQ-OPP , Page 4.

11 Fomesafen Registration Review Chronology Phase I: Docket Opening Action EPA Final Work Plan Estimated Date ** Actual Date Preliminary Work Plan; Problem Formulation Docket Opened Public Comments March 2007 March June /28/07 3/28/02 6/26/07 Final Work Plan August /29/07 Phase II: Case Development Draft Risk Asst Public Comments 1 st Quarter st 2 nd Quarter /22/09 4/22/09 8/21/09 Publish Draft Risk Assessment EPA Requests Consultation with NMFS and FWS /22/09 NMFS Denies Consultation 5/22/09 Phase III: Final Decision Final Risk Assessment; Propose Decision (mitigations, if needed); Final Decision 11 ** Fomesafen Final Work Plan (FWP) For Registration Review August 2007, Environmental Protection Agency, Pesticide Re-evaluation Division, Docket ID # EPA-HQ-OPP , Page 4.

12 Fomesafen Registration Review Chronology Phase I: Docket Opening Action EPA Final Work Plan Estimated Date ** Actual Date Preliminary Work Plan; Problem Formulation Docket Opened Public Comments March 2007 March June /28/07 3/28/02 6/26/07 Final Work Plan August /29/07 Phase II: Case Development Draft Risk Asst Public Comments 1 st Quarter st 2 nd Quarter /22/09 4/22/09 8/21/09 Publish Draft Risk Assessment EPA Requests Consultation with NMFS and FWS /22/09 NMFS Denies Consultation 5/22/09 Phase III: Final Decision Final Risk Assessment 3 rd Quarter 2009 Not yet Final Risk Assessment; Propose Decision (mitigations, if needed); Final Decision Public Comments Final Decision 3 rd 4 th Quarter st Quarter ** Fomesafen Final Work Plan (FWP) For Registration Review August 2007, Environmental Protection Agency, Pesticide Re-evaluation Division, Docket ID # EPA-HQ-OPP , Page 4.

13 NMFS Stated Reasons for Refusing Consultation on Draft Fomesafen Effects Determination Request for formal consultation premature - revised fomesafen registration review package may trigger subsequent consultation. EPA s effects determination for fomesafen does not contain the information necessary to initiate formal consultation. - Description of the action and action area - A description of any listed species or critical habitat that may be affected by the action - Cumulative effects analysis - Analysis of potential mixtures - Information on direct lethal or sublethal responses - Information on indirect effects on prey, primary producers, riparian vegetation - Other relevant available information: on the action, the affected species, or critical habitat 13 Reference Letter from A. Somma (NMFS/Endangered Species Division) to A. Williams (EPA/OPP/PRD) of May 22, 2009, Subject: Request for Endangered Species Act Section 7 Consultation on the Environmental Protection Agency's Review of their Registration of Pesticide Products Containing the Active Ingredient Fomesafen

14 EPA draft endangered species assessment (April 2009) Lower tier screening assessment - directly or indirectly adversely affect endangered: birds, amphibians, reptiles, small mammals, monocots, dicots, aquatic species, fish Proposed draft mitigation: - Ground application 350 feet (plants), 10 feet (animals) - Aerial application - 1,000 feet (plants), 100 feet (animals) Extensive public comments (~125) from growers/grower groups, universities, crop consultants, state departments of ag., IR-4, CLA, FESTF, Syngenta Syngenta submitted additional scientific information / assessments for refining of risk assessment 14

15 Example of Potential Impacts of the Draft Risk Assessment on Fomesafen Use Soybeans Counties in red are those listed in EPA s draft assessment where fomesafen s soybean use would be restricted on a local basis. 15

16 Proposed Refinements to EPA s May Affect Determinations from Draft Assessments Category DIRECT EFFECTS: Birds, Reptiles, Amphibians (terrestrial phase) Small Mammals - chronic Terrestrial invertebrates - acute **Terrestrial plants INDIRECT EFFECTS **Potential effects on plants in habitats, such as riparian zones, wetlands, and designated critical habitats Proposed Refinements Updated bird reproduction study submitted; no effects at highest dose tested Refine exposure values Additional insect effects data submitted showing no toxicity at high rates Refine exposure values Additional plant effects data submitted Refine proximity analysis using FESTF/ MJD Refine exposure analysis (spray drift, runoff) Additional plant effects data submitted Refine exposure analysis (spray drift, runoff) ** To be discussed in detail in presentation by Dr. Jay Overmyer; Fomesafen Endangered Species Assessment: Novel Approaches for Assessment Refinement 16

17 Conclusions EPA s registration review program for fomesafen currently delayed due to delays in the consultation process EPA s draft risk assessment was a screening level assessment with multiple conservative assumptions leading to unrealistic exposure and effects scenarios. Refinements are available to apply to a revised risk assessment in Phase III of registration review. 17