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EPA/OPPTS RIN: 2070-AD61 Publication ID: Spring 2009 
Title: Endocrine Disruptor Screening Program (EDSP); Policy and Procedures for Initial Screening 
Abstract: Section 408(p) of the Federal Food, Drug, and Cosmetic Act, as amended by the 1996 Food Quality Protection Act, directs EPA to establish and implement a program whereby industry will be required to screen and test all pesticide chemicals to determine whether certain substances may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other endocrine effect as the Administrator may designate. The requirements of section 408(p) were implemented through the creation of the Endocrine Disruptor Screening Program (EDSP) in 1998. EDSP consists of three major parts developed in parallel: 1) Assay validation. Under FFDCA section 408(p), EPA is required to use ‘‘appropriate validated test systems and other scientifically relevant information’’ to determine whether substances may have estrogenic effects in humans or other endocrine effects as the Administrator may designate. On March 25-27, 2008, the FIFRA Science Advisory Panel (SAP) reviewed the Agency's proposed EDSP Tier 1 screening battery, and in a report dated June 11, 2008, the SAP recommended that the Agency proceed with Tier 1 screening using the proposed battery. At this moment, validation is complete for all but one of the Tier 1 assays that were included in the proposed Tier 1 screening battery (i.e., ER Binding). The ER Binding assay is expected to complete the validation process in April 2009. The final Tier 1 battery will be announced in a separate Federal Register document that the Agency anticipates issuing in spring 2009. Efforts to validate the Tier 2 tests are underway. 2) Priority setting. EPA described its priority setting approach to select pesticide chemicals for initial screening on September 27, 2005 (70 FR 56449), and announced the draft list of initial pesticide active ingredients and pesticide inerts to be considered for screening under FFDCA on June 18, 2007 (72 FR 33486). After considering public comment, EPA issued the final list of 67 pesticide active ingredients and high production volume (HPV) pesticide inert chemicals for initial screening on April 15, 2009 (74 FR 17579). 3) Procedures. On December 13, 2007 (72 FR 70842), EPA published a draft document in the Federal Register that described the policies and procedures EPA generally intended to adopt for initial screening of chemicals under EDSP. Following review and revision based on the public comments, on April 15, 2009 (74 FR 17560), EPA described the specific details of the policies and procedures that EPA generally intends to adopt for initial screening under the EDSP, including the statutory requirements associated with and format of the test orders, as well as EPA’s procedures for fair and equitable sharing of test costs and handling confidential data. Additional information about the EDSP is available at http://www.epa.gov/scipoly/oscpendo/index.htm. 
Agency: Environmental Protection Agency(EPA)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: Not Yet Determined     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 15 USC 2603 "TSCA"    21 USC 346(a) "FFDCA"    42 USC 300(a)(17) "SDWA"    7 USC 136 "FIFRA"   
Legal Deadline:  None
Timetable:
Action Date FR Cite
Notice; Draft Procedures  12/13/2007  72 FR 70842   
Final; Procedures  04/15/2009  74 FR 17559   
Additional Information: SAN No. 4728; EPA publication information: Notice; EPA Docket information: EPA-HQ-OPPT-2007-1080
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Federal 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Information URL: http://www.epa.gov/scipoly/oscpendo/index.htm  
RIN Data Printed in the FR: No 
Agency Contact:
William Wooge
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7203M,
Washington, DC 20460
Phone:202 564-8476
Fax:202 564-8483
Email: wooge.william@epa.gov

Gary Timm
Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
7203M,
Washington, DC 20460
Phone:202 564-8474
Fax:202 564-8483
Email: timm.gary@epa.gov