# UNITED STATES DISTRICT COURT EASTERN DISTRICT OF MISSOURI EASTERN DIVISION WILLIAM R.

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2/10/2017 Meeting | EPA Science Advisory Board (SAB) | US EPA A rn A ^ b rW UnimJSWn ^ nTM la' ^riK tin EPA Science Advisory Board (SAB) Meeting Chartered SAB Quality Review of Draft Report Reviewing EPA's Reanalysis of Key Issues Related to Dioxin Toxicity and Response to NAS Comments 06/06/2011 12:00 PM - 04:00 PM Federal Register Notice Announcing the Meeting Type of Meeting Location Advisory Telephone only Expert Committee or Panel SAB Contacts Stephanie Sanzone 202-564-2067 sanzone. stephanie@epa.gov See EPA's PDF page to learn more about PDF files.

3 February 2009 Draft Selection Criteria to identify Key In Vivo Mammalian Studies that Inform Dose-Response Modeling for 2,3,7,8-Tetrachlorodibenzo-p-dioxin (TCDD)a Study Feature Chemical, purity, matrix/medium Peer review Study design, execution, and reporting Study subject: species, strain, and sensitivity for given endpoint; litter; life stage; gender Exposure route Dose level Exposure frequency, duration, and timing Controls Response Statistical evaluation Selection Rationale Primary*3 Secondary^ TCDD-only doses included, purity specified, TCDD purity or matrix not clearly identified matrix in which TCDD is administered is identified Independently peer-reviewed, publicly available Supplementary materials accompanying peer-reviewed publication Clearly documented and consistent with standard Testing protocol provides incomplete toxicological principles, testing protocols, coverage of relevant endpoint-specific and practice (i.e., endpoint-appropriate, measures, particularly for negative findings particularly for negative findings) Mammalian species Mammalian species, in vivo, but only Strain and gender identified studying an artificially sensitive subject Animal age at beginning of treatment identified (e.g., knockout mouse) Litter confounders (within/between) accounted for Currently Excluded Studies of dioxin-like compounds (DLCs) or mixtures Not formally peer-reviewed; literature not publicly available Studies not meeting standard principles and practices Non-mammalian or not in vivo Oral Parenteral (e.g., intravenous, intramuscular, Inhalation, dermal, ocular intraperitoneal, subcutaneous) Lowest dose <200 ng/kg-d for noncancer endpoints and <1 ^g)/kg-d for cancer Lowest dose >200 ng/kg-d for noncancer endpoints, or >1.0 ^.g/kg-d for cancer Dosing regimen characterized and explained Characterization/explanation missing or cannot be determined Appropriate and well characterized Effect reported, but with no negative control Effect relevant to human health Magnitude outside range of normal variability Precursor effects, or adaptive responses Lethality potentially relevant to human health Clearly described and appropriate to the endpoint Limited statistical context and study design (e.g., per error variance, magnitude of effect) a NAS (2006) commented that the selection of data sets for quantitative dose-response modeling needed to be more transparent.

Cable Viewer Viewing cable 06BANGKOK3237, SEED PIRACY IN THAILAND: A "GROWING" PROBLEM If you are new to these pages, please read an introduction on the structure of a cable as well as how to discuss them with others.

Cable Viewer Viewing cable 10NEWDELHI355, NSA MENON DISCUSSES REGIONAL SECURITY AND TRADE If you are new to these pages, please read an introduction on the structure of a cable as well as how to discuss them with others.

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Telephone: (702) 385-4202 BRADLEY & MERRELL c/o Jones, Jones, Close & Brown 300 South Fourth Street, Seventh Floor Las Vegas, Nevada 89101-6026 Fax: (702) 385-1655 July 21, 1993 VIA HAND DELIVERY Honorable Lawrence R.

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