EDSP: T IER 1 T ESTING I NFORMATION C OLLECTION ISRTP 2010 Endocrine Workshop EDSP Compliance December 13, 2010 Susan Ferenc, DVM, Ph.D

Information Collection Request (ICR) Agencies requesting submission of information by the public must demonstrate the “practical utility,” or benefit, of the information and enumerate the public “burden,” or cost, of the collection – The Tier 1 data and OSRI are needed and will be used to provide information that will allow EPA to determine “that a chemical does, or is not likely to, have the potential to interact with the endocrine system.”

ICR Practical Utility: Means “the actual not merely theoretical or potential, usefulness of information to or for an agency, taking into account its accuracy, validity, adequacy, and reliability, and the agency’s ability to process the information it collects in a useful and timely fashion…” Burden: Means “the total time, effort or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency, including: Developing, acquiring, installing, and utilizing technology and systems for the purpose of collecting, validating, and verifying information; Searching data sources.”

EDSP Information Collection Request OMB Action: Approved with Change “Terms of Clearance” “…under the principles of the PRA, EPA should promote and encourage test order recipients to submit Other Scientifically Relevant Information (OSRI) in lieu of performing all or some of the Tier I assays, and EPA should accept OSRI as sufficient to satisfy the test orders to the greatest extent possible.” “…to further validate EPA’s burden estimates, OMB requests that EPA provide a report re-estimating the burden of this information collection based on responses to the Tier I test orders, including the use of cost-sharing and data compensation, the submission and acceptance of existing data and OSRI, and description of any instances in which submission of OSRI was deemed insufficient to satisfy the testing order.” “… in order to ensure that EPA has maximized the practical utility of the Tier I assays…, EPA should ensure sufficient opportunity prior to submission of any revision to this collection for public comment and peer review of the EPA tools to be developed to guide the agency decisions on whether a chemical must proceed to Tier II, including the Weight of Evidence Approach and Standard Evaluation Procedures.”

Status of List 1 Activity All responses to List 1 Test Orders have been submitted EPA has made OSRI decisions on 15 chemicals Of the 58 List 1 pesticide active ingredients: 30 are being “supported” in consortia 143 members in total, 4-5 members per consortia on average, range of 2-17 members 21 are being “supported” by a single company 7 are not being “supported” 20 registrations have been voluntarily cancelled Of the 9 List 1 pesticide inert ingredients: 2 inerts are being “supported” in consortia One consortium of 2 companies, the other of 7 (so far) Data Submission OSRI submitted for 46 actives New Data generated for 5 actives and 2 inerts 769 Test Orders sent out: 173 responses to “support,” 596 “other” responses (e.g., formulators exemption, opt-out of pesticide market, not subject to test order, response outstanding) There will be only one final response for each “supported” chemical

ASSAYSCodeAvg In Vitro Assays: Androgen Receptor Binding (Rat Prostate) $21,035 Aromatase (Human Recombinant) $10,060 Estrogen Receptor Binding (Rat Uterine) $21,035 ER Transcriptional Activation $15,113 Steroidogenisis (Human Cell Line) $16,222 In Vivo Assays: Fish Sort Term Reproduction $114,767 Hershberger (Rat) $30,190 Female Pubertal (Rat) $76,770 Male Pubertal (Rat) $77,740 Amphibian Metamorphosis (Frog) $106,087 Uterotrophic (Rat) $32,140 TOTAL$521,158

Total Cost of OSRI (46 chemicals)*$1,584,000 Per Chemical Submission$34,435 Per Test Order Recipient*$8,909 Estimated Costs for Generation and Submission of OSRI

ASSAYSCodeAvgOSRISavings In Vitro Assays: Androgen Receptor Binding $21,0352$42,070 Aromatase (Human Recombinant) $10,0600$0 Estrogen Receptor Binding $21,0352$42,070 ER Transcriptional Activation $15,1132$30,227 Steroidogenisis (Human Cell Line) $16,2220$0 In Vivo Assays: Fish Sort Term Reproduction $114,7670$0 Hershberger (Rat) $30,1904$120,760 Female Pubertal (Rat) $76,7702$153,540 Male Pubertal (Rat) $77,7404$310,960 Amphibian Metamorphosis (Frog) $106,0872$212,173 Uterotrophic (Rat) $32,1402$64,280 TOTAL$521,158$976,080

Total Burden EPACPDA List 1 Tier 1 Program$35,923,228$70,840,814 List 2 Tier 1 Program$52,071,780$121,906,952 Battery Costs for List 1$34,917,586 Battery Costs for List 2$69,835,172

Thank you!