Introduction to Session II: Incorporating Existing Data into the EDSP

1. Introduction to Session II:Incorporating Existing Data into the EDSP Erik R. Janus Director, Human Health Policy CropLife America

2. A brief history of using existing EDSP data … • August 1998 – EDSTAC final recommendations (Conceptual Framework & Principles): • All pesticides subject to HTPS should not be required to run ER and AR binding and/or transactivation studies • “there may be individual cases in which T1 is bypassed,” such as: • Food use pesticides with 2-gen repro studies • “owner has voluntarily decided to proceed directly to testing”

3. A brief history of using existing EDSP data … • EDSP Proposed Statement of Policy (Federal Register, 63(248), 28 December 1998, p. 71544) • “Functional equivalency— an assay, test, or endpoint may be defined as being ‘‘functionally equivalent’’ to another assay, test, or endpoint when it provides equivalent information for each endpoint being studied. For purposes of the EDSP, assays, tests, and endpoints must be standardized and validated prior to use. The standardization and validation process will provide data and information that will allow EPA to develop guidance on the use of functionally equivalent assays, tests, and endpoints prior to the implementation of the screening program.”

4. A brief history of using existing EDSP data … • EDSP Chemical Selection Approach for Initial Round of Screening (Federal Register, 70(186), 27 September 2005, p. 56452- 56453) •  “Although a relatively broad range of toxicity data are available for pesticide active ingredients regulated under FIFRA, in most cases EPA has not yet established how the available data might be confidently used to predict the endocrine disruption potentials of these chemicals.” • “When the draft initial list is published, any company subject to a testing requirement may request, during the comment period, a waiver (supported by appropriate data) on the grounds that the chemical is an endocrine disruptor and that EDSP screening is unnecessary.”

5. A brief history of using existing EDSP data … • EDSP Draft List of Initial Pesticide Active Ingredients and Pesticide Inerts to be Considered for Screening under FFDCA(Federal Register, 72(116), 18 June 2007) • IV. H. Bypassing Tier 1 Screening (pages 33498-33499) • “As indicated in the September 2005 Federal Register notice, any company subject to a testing requirement under Tier 1 may assert (supported by appropriate data) during the comment period for the draft list that the chemical is an endocrine disruptor and that the Tier 1 EDSP screening is unnecessary. EPA does not intend to permit chemicals on this list to bypass Tier 1 screening and move directly to Tier 2 testing without appropriate data to support such an action.”

6. 2009 EDSP Policies & Procedures • FFDCA section 408(p) test order recipients may cite or submit existing data (i.e., other scientifically relevant information) • information that identifies substances as having the potential to interact with the estrogen,androgen, and/or thyroid system(s) • information demonstrating whether substances have an effect on the functioning of the endocrine system • data from assays that perform the same function as EDSP Tier 1 assays

7. OSRI guidance • Approach for Considering Other Scientifically Relevant Information (OSRI) under the Endocrine Disruptor Screening Program • developed by EPA to provide guidance to EPA staff and managers who will be reviewing the responses to EDSP Tier 1 Orders issued under • provides general guidance and is not binding on either EPA or any outside parties. • “Anyone may provide other scientifically relevant information, and the Agency will assess the information for appropriateness on a case-by-case basis to determine whether the information can be used to satisfy part or all of the Tier 1 Order and/or otherwise inform the Tier 1 determination.” • EPA will respond to the submitter in writing and will make its determination publicly available.

8. What are the some of the issues for this session? • What are the data needs of EDSP T1? • What value is added by T1 assays above and beyond data generated by FIFRA guideline studies? • Where can existing data satisfy T1 data needs? • How can existing data satisfy T1 data needs in some “functionally equivalent” manner?

9. Overview of Session II • Dr. Steve Levine: What current information fulfills the needs of EDSP screening? • Dr. Jim Stevens: What can EDSP screening tell us that the FIFRA test guidelines cannot? • Panelists: Dr. Jim Lamb, Dr. Jeff Pregenzer, Dr. Lorenz Rhomberg