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Fish Short-Term Reproduction (Fish Screen) Assay Peer Review Materials

EPA announced in a July 2007 Federal Register Notice (PDF) (4 pp, 67K, About PDF) the approach it intends to take for conducting peer reviews of the Tier 1 screening assays and Tier 2 testing assays that are being validated.  As described in the Federal Register Notice, peer review materials will be posted as they become available. Materials may include the documents to be peer reviewed, background documents, the charge to the peer reviewers, and reports that summarize the results of peer reviews. Peer review materials for the Fish Screen Assay can be accessed below:

You will need the free Adobe Reader to view some of the files on this page. See EPA's PDF page to learn more. If you need help accessing these PDF documents, please contact William Wooge at 202-564-8476 or wooge.william@epa.gov for assistance.

Charge to Peer Reviewers

Charge to Peer Reviewers (PDF) (2 pp, 14K)

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Integrated Summary Report

Validation of the Fish Short-Term Reproduction Assay: Integrated Summary Report (PDF) (104 pp, 461K)

Attachment A: Endocrine Disruptor Screening Program Validation Paper

Validation of Screening and Testing Assays Proposed for the EDSP (PDF) (21pp, 131K)

Attachment B: OECD Fish Screening Assay Detailed Review Paper

OECD Series on Testing And Assessment Number 47 Detailed Review Paper on Fish Screening Assays For The Detection of Endocrine Active Substances (PDF) (177 pp, 906K)

Attachment C: OECD Fish Short-term Reproduction Assay Phase 1B Report

Series on Testing And Assessment Number 61 Report of The Validation of The 21-Day Fish Screening Assay For The Detection of Endocrine Substances (Phase 1B) (PDF) (140 pp, 1.2M)

Attachment D: Revised Draft Final Report on Fathead Minnow Fish Screening Assay OECD Phase 1 B Follow-Up

Revised Draft Final Report on Fathead Minnow (Pimephales promelas) Fish Screening Assay OECD Phase 1 B Follow-Up (PDF) (656 pp, 51.2M)

Attachment E: US EPA Fish Short-term Reproduction Assay Inter-laboratory Study Report

DRAFT FINAL REPORT Inter-Laboratory Validation of the Fish Short-term Reproduction Assay, Run Simultaneously Across Three Independent Contract Laboratories (PDF) (96 pp, 3.7M)

DRAFT FINAL REPORT and 12 Corresponding Individual Laboratory Reports (ZIP) (13 PDF files, 113M)

Attachment F: Fish Short-term Reproduction Assay Protocol

Fish Short-Term Reproduction Assay Test Protocol Fathead Minnow (PDF) (29 pp, 415K)

Attachment G: Short-term Test Method for Assessing the Reproductive Toxicity of Endocrine Disrupting Chemicals Using the Fathead Minnow

EPA/600/R-01/067: A Short-term Test Method for Assessing the Reproductive Toxicity of Endocrine Disrupting Chemicals Using the Fathead Minnow (Pimephales promelas) (PDF) (170 pp, 7.4M)

Attachment H: Histopathology Guidelines for the Fathead Minnow 21-day Reproduction Assay

Histopathology guidelines for the Fathead Minnow (Pimephales promelas) 21-day Reproduction Assay July 6, 2006 (PDF) (59 pp, 5.1M)

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Background Documents

Reference 1: Reference 1 OECD Phase 2 Report: Draft Report of the Validation of the 21-Day Fish Endocrine Screening Assay for the Detection of Endocrine Active Substances (Phase 2-Testing Negative Substances)

Draft Report of The Validation of The 21-Day Fish Endocrine Screening Assay For The Detection Of Endocrine Active Substances Phase 2-Testing Negative Substances (PDF) (68 pp, 366K)

Reference 2: Reference 2 OECD Guidance Document 23: Testing and Assessment: Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures

OECD Series On Testing And Assessment Number 23 Guidance Document On Aquatic Toxicity Testing Of Difficult Substances And Mixtures (PDF) (53 pp, 218K)

Reference 3: Fish Short-term Reproduction Assay Discussion Paper

Fish Screening Assay Discussion Paper 9/18/2006 U.S. EPA (PDF) (87 pp, 1.6M)

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Peer Review Results

Peer Review Results for the Fish Short-Term Reproduction (Fish Screen) Assay (PDF) (110 pp, 491K)

EPA Response to Peer Review Comments (PDF) (26 pp, 249K)

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