Endocrine Disruptors Research Program and CAFOs

Endocrine Disruptors Research Program and CAFOs Elaine Z. Francis National Program Director, Pesticides and Toxics Research US EPA Workshop on Fate and Effects of Hormones in Waste from Concentrated Animal Feeding Operations August 21, 2007 ’01 Finalized Multi-Year Plan ‘95 Held 2 Int’l Workshops ’99 Named Nat’l Prog Director ’03 NRMRL Impl Plan ’04 Program Review by BOSC ’95 Issued Broad RFA ‘94 RAF IDs EDCs as an Issue ’96 ORD IDs EDCs as High Priority ‘97 RAF Published Interim Guidance Document ’98 Pub. Peer-Rev. Research Plan ’02 Began Comp Tox Program ’03 Issued Sys Bio RFA ’05 Issued Exposure RFA ’00 NHEERL Impl. Plan ’02 Issued HTPS RFA ’00 Held Workshop ’04 Issued Low Dose RFA ’06 Issued CAFOs RFA ’04 PART Review by OMB ’02 Held Workshop ’06 Held Workshop ’98 Issued Interagency RFA on Pop. Effects ’96 Issued Broad RFA ’00 Issued Interagency RFA on Epi Annotated History of EPA’s Annotated History of EPA’s EDCs Research Program EDCs Research Program 2 ’03 Updated MYP ’04 Updated NHEERL Impl Plan ’07 Held Interagency Workshop ’07 Held CAFOs Workshop ’04 Held Progress Review of Epi Grants ’07 Updated MYP ’07 BOSC Mid-Cycle Review 1994 2007 Endocrine Disruptors Research 14 12 Dollars in Millions $12.1 $10.7 $8.9 $8.0 $10.9 $10.4 $10.5 $10.5 $10.1 1998 - 2008 $12.8 $12.6 10 8 6 4 2 Total Program STAR funding 40.7 Total FTEs (’08) 31.8 NHEERL 3.9 NERL 2.0 NRMRL 3.0 NCER t ed ed ed ed ed ed ed ed ed ed es act nact nact nact nact nact nact nact nact nact equ n 8 E 99 E 00 E 01 E 02 E 03 E 04 E 05 E 06 E 07 E 08 R 9 20 20 20 20 20 20 20 20 20 19 19 0 3 Funding levels reflect total program including payroll, travel, WCF, and operating expenses. STAR: Science to Achieve Results extramural grants EDCs Extramural Research Program Supported through STAR Program since ‘96 EPA-only RFAs in 1996, 1997, 2004, 2005, 2006 Multi-Agency participation in 1998/99 and 2000 EPA-only Computational Toxicology RFAs in 2002 and 2003 Portfolio includes 55 grants (www.epa.gov/ncer) Broad array of topics, species, chemicals Support approximately $41 M total PIs have received > $15.5 M in additional funding Comp Tox supporting 7 grants ($4.8 M) Grants awarded in other research programs - >18 (>$4.6 M) 4 Lessons Learned in EDCs Extramural Research Program Value of STAR Grantee Workshops with EPA and other scientists 1998 (with NIEHS); 2000; 2002; 2004 (epidemiology); 2006; 2007 (CAFOs) Topics of early RFAs were broad and cast a large net Subsequent RFAs have been more targeted Where amenable, recently more awards have been made as cooperative agreements instead of grants Provides a greater opportunity of sharing of data and leveraging resources Appears to be a win-win situation 5 Multi-Year Plan: Long-Term Goals LTG 1 - Provide a better understanding of the science underlying the effects, exposure, assessment, and management of endocrine disruptors LTG 2 - Determine the extent of the impact of endocrine disruptors on humans, wildlife, and the environment LTG 3 - Support EPA’s screening and testing program 6 Assays Under Development Under LTG 3: Supporting Agency’s Screening and Testing Program T1 - In vitro ER (rat cytosol) hrER binding a AR (rat cytosol) hrAR binding a Steroidogenesis - rat sliced testes - H295R a Aromatase - placenta - recombinant a T1 - In vivo Hershberger Uterotrophic Pubertal (female) Pubertal (male) Frog metamorphosis Fish screen T2 - In vivo Mammalian 2-gen Avian 2-gen Amphibian dev, repro Mysid 2-gen Fish 2-gen In utero/lactation -tier ? a a alternate 7 Examples of Research - LTG 1: Understanding Underlying Science Determining classes of chemicals that act as EDCs, their modes of action, and their potencies • (Anti)androgens, (anti)estrogens, antithyroids Studying approaches to assess cumulative risk to EDCs Determining the dose-response curves for EDCs at environmentally relevant concentrations Studying the impact of developmental exposures in the short term and later in life Examining the ability to extrapolate across species 8 Examples of Research – LTG 1: Understanding Underlying Science Identifying major sources of EDCs entering the environment, focusing on: • wastewater treatment plants • drinking water treatment plants • concentrated animal feeding operations Developing tools to characterize and minimize exposures to EDCs 9 Examples of Research – LTG 2: Determining Impacts Determining the magnitude of adverse impacts on wildlife • • • Evidence that EDCs are affecting wildlife at individual level Evidence that EDC effects in individuals are causing population-level effects What tools are needed to provide linkage between population level effects and diagnostic evidence of EDC impacts Determining the magnitude of adverse impacts of EDCs on human health • Supported 12 epidemiology studies across federal agencies 10 Exposure to high levels of PBBs prenatally and via breast milk may impact puberty in girls Conducted large scale exposure studies to assess exposures of children to environmental chemicals, including some suspected EDCs Examples of Research – LTG 2: Determining Impacts Paper Mill Effluents Waste Water Treatment Effluents • Collaborations with: Office of Water, 10 EPA Regions; Global Water Research Coalition, state of Ohio, Chicago Sludge Drinking Water CAFOs Dosed Lake Study with Canada Developing novel methods to characterize exposures to mixtures Calumet Water Reclamation Plant 11 Examples of CAFOs Research – LTG 2 High levels of estrogens found in swine lagoons Androgenic activity found in run-off from cattle farms Characterized impact of exposures on current aquatic organisms and estimated future population-level effects Determined temporal patterns of androgenic activity and concentrations of both α- and β-trenbolone (metabolites of trenbolone acetate implanted in cattle) in feedlot discharge Using Kbluc, MDA-kb2 Cross-Laboratory/Center Study: Assessment of the Occurrence and Potential Risks of EDCs in Discharges from CAFOs • Issued RFA and made 7 awards 12 What’s in the Future? Updating Multi-Year Plan • Taking into consideration recommendations by BOSC Program Review Mid-cycle review in September 2007 • Continuing to develop new methods/tools and applying them to environmentally relevant issues – e.g., WWTP, CAFOs, pharmaceuticals Interest in expanding our partnerships and collaborations Communicating results • Informal interactions with client offices within EPA • Workshops • Developing a website • Synthesis document that summarizes intramural and extramural research 13 Summary There is global concern regarding exposures to some environmental agents that interfere with endocrine systems EPA has developed a research program that has three Long Term Goals and is addressing specific key science questions EPA’s EDCs’ program is unique among research organizations • • • • • 14 Human health and wildlife Effects, exposure, risk management Intramural and extramural research Core and problem-driven Leveraged with collaborators in other federal agencies, academia, and industry