Human Studies Review Board
Human Studies Review Board
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Meeting to be held at Holiday Inn National Airport/Crystal City, 2650 Jefferson Davis Hwy, Arlington, VA 22202, 703-684-4780
- Final Agenda (PDF) (4 pp, 52K)
- Federal Register Notice
- Meeting Minutes (PDF) (74 pp, 427KB)
- Board/consultant list (PDF) (4 pp, 24K)
- February 17, 2009 EPA Human Studies Review Board Meeting Report (PDF) (22 pp, 130KB)
- Background Presentation (PDF) (13 pp, 141K)
- June 24-25, 2009 Human Studies Review Board Meeting Final Report (PDF) (40 pp, 227KB)
1. Chlorpyrifos
1a. EPA White Paper
1b. Nolan et al (1982)
- MRID 124144 Nolan et al (1982) – Please contact Lu-Ann Kleibacker at 202-564-7189 for a copy of this document.
- EPA Qs and DAS Response Re Nolan Study – Please contact Lu-Ann Kleibacker at 202-564-7189 for a copy of this document.
- EPA Science Rvw (DER) Nolan (5-26-09) (PDF) (13 pp, 229KB)
- EPA Ethics Review Nolan (5-29-09) (PDF) (6 pp, 45KB)
1c. Honey Cut & DeGeare (1993)
- MRID 43062701 Honeycutt & DeGeare 1993 – Please contact Lu-Ann Kleibacker at 202-564-7189 for a copy of this document.
- DAS Supplement Re-Honeycutt & DeGeare Study – Please contact Lu-Ann Kleibacker at 202-564-7189 for a copy of this document.
- EPA Science Rvw (DER) Honeycutt Study (5-22-09) (PDF) (63 pp, 862KB)
- EPA Ethics Review Honeycutt & DeGeare (5-29-09) (PDF) (9 pp, 60KB)
1d. Kisicki et al (1999)
- MRID 44811002 Primary Report of Kisicki (1999) Study – Please contact Lu-Ann Kleibacker at 202-564-7189 for a copy of this document.
- MRID 45144101 Brzak (2000) Report of Analytical Phase of Kisicki Study – Please contact Lu-Ann Kleibacker at 202-564-7189 for a copy of this document.
- MRID 47429401 DAS Response to EPA Query (5-14-08) – Please contact Lu-Ann Kleibacker at 202-564-7189 for a copy of this document.
- EPA Science Rvw (DER) Kisicki (5-28-09) – Please contact Lu-Ann Kleibacker at 202-564-7189 for a copy of this document.
- EPA Science Rvw (DER) Kisicki (5-27-09) (PDF) (45 pp, 438KB)
- EPA Ethics Rvw Kisicki et al (6-1-09) (PDF) (11 pp, 77KB)
1e. SAP Materials
- EPA Issue Paper-Chlorpyrifos Hazard & Dose Response 4-21-08) (PDF) (81 pp, 823KB)
- SAP Meeting Minutes 2-17-08 (PDF) (80 pp, 4.6MB)
1f. Coulston et al (1972)
- MRID 95175 Coulston – Please contact Lu-Ann Kleibacker at 202-564-7189 for a copy of this document.
- EPA Qs and DAS Response Re Coulston Study – Please contact Lu-Ann Kleibacker at 202-564-7189 for a copy of this document.
- EPA Science Rvw (DER) of Coulston et al (5-26-09) (PDF) (8 pp, 141KB)
- EPA Ethics Review Coulston (5-29-09) (PDF) (9 pp, 61KB)
2. CLBR Protocol LNX-002
- CLBR Protocol LNX-002 3-23-09
- Supplemental IIRB, Inc. Documentation (PDF) (56 pp, 4.4MB)
- EPA Science & Ethics Rvw LNX-002 5-18-09 (PDF) (28 pp, 253KB)
3. ICR Completed Study A382
- MRID 47732701 A382 Primary Report – Please contact Lu-Ann Kleibacker at 202-564-7189 for a copy of this document.
- EPA 4-9-09 Email notification of gaps in record (PDF) (2 pp, 19KB)
- MRID 47734901 Supplemental LANXESS submission – Please contact Lu-Ann Kleibacker at 202-564-7189 for a copy of this document.
- EPA Science & Ethics Rvw ICR Protocol A382 3-7-08 (PDF) (34 pp, 242KB)
- Discussion of ICR A382 Protocol from HSRB Report on April 2008 mtg (PDF) (4 pp, 23KB)
- EPA Ethics Rvw ICR Study A382 5-22-09 (PDF) (15 pp, 150KB)
- EPA Science Rvw Completed Study A382 5-29-09 (PDF) (5 pp, 88KB)
4. AHEFT Mix-Load Water Soluble Packages Scenario
- Mix-Load WSP Scenario & Protocol AHE120 (PDF) (552 pp, 14.4MB)
- Supplemental AHETF Submission of SOPs (PDF) (78 pp, 1.7MB)
- EPA Science & Ethics Rvw AHE120 4-8-09 (PDF) (54 pp, 694KB)
- AHETF Response to EPA Review (5-12-09) (PDF) (13 pp, 1.9MB)
5. Final Presentations
- HSRB Criteria for Review of Pre-Rule Intentional Dosing Studies (PPT) (8 pp, 287KB)
- Three Pre-Rule Studies of Chlorpyrifos (PPT) (84 pp, 1.1MB)
- EPA Review of Carroll-Loye Protocol LNX-002 (PPT) (29 pp, 223KB)
- EPA Review of Completed ICR Study A-382 (PPT) (29 pp, 1MB)
- General AHETF Model(PPT) (1 pg, 200KB)
- AHETF Scenario Design and Field Study Protocol for Mixing and Loading of Pesticide Products in Water-Soluble Packaging (PPT) (33 pp, 2.4MB)
- Chair's Summary of Board Recommendations (PPT) (17 pp, 293KB)
For a hard copy of any of these documents, please contact Lu-Ann Kleibacker at 202-564-7189.
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