All Past Events

Federal Register Notices

December 3, 2020

• Federal Register notice: PDF HTML

NTP Board of Scientific Counselors Meeting Meeting Materials

December 3, 2020

December 3, 2020

• Operationalizing the DNTP Strategic Realignment
• DNTP Strategic Planning Framework
  • Research Program Introductions for DNTP/NIEHS

December 4, 2020

• Cardiovascular Health Effects Innovation Program
• Developmental Neurotoxicity Health Effects Innovation Program

NTP Board of Scientific Counselors Meeting Presentations

December 3, 2020

December 3, 2020

• Report from NIEHS/NTP Director
• Introduction to Meeting Agenda and BSC Meetings 2020-2021
• Operationalizing the DNTP Strategic Realignment
• DNTP Strategic Planning Framework

December 4, 2020

• Introduction to Meeting and Research Programs
• Cardiovascular Health Effects Innovation Program
• Developmental Neurotoxicity Health Effects Innovation Program

Symposium Webinar: Use of the Kinetically Derived Maximum Dose in Toxicity Testing Presentations

September 30, 2020

Welcome and Introductions 
Nicole Kleinstreuer, Ph.D., NICEATM

Use and Evaluation of KMD Data at USEPA's Office of Pesticide Programs
Anna Lowit, Ph.D., EPA

Current State-of-play: OECD Discussions on Doses Selection in Chronic Toxicity Studies
Anne Gourmelon, OECD

Problem Formulation: Background, Motivation, and Expected Outcomes
Michelle Embry, Ph.D., Health and Environmental Sciences Institute

Maximum Tolerated Dose: Concepts and Background
Chad Blystone, Ph.D., DABT, NTP

Concepts of Non-linear Pharmacokinetics and KMD
Alan Boobis, Ph.D., Imperial College London

Implications of Non-linear PK in Toxicity Testing and Interpretation of Dose-response Data
Salil Pendse, Nuventra, Inc.

Determining an Inflection Point from External-internal Dose Data
Philip Villanueva, EPA

Estimating Human Exposures and Comparison to Doses Used in Testing
Jeff Dawson, EPA

Dose Setting and Considerations for the 3Rs
Fiona Sewell, Ph.D., National Centre for the Replacement Refinement & Reduction of Animals in Research

Integration of TK into Toxicity Studies and Dose Level Setting
Jean Domoradzki, Ph.D., DABT, Corteva Agriscience

Integrating KMD/TK Data with MoA and Other Information in a Weight of Evidence Approach
Harvey Clewell, Ph.D., Ramboll

Federal Register Notices

September 2, 2020

• Federal Register notice: PDF HTML

Scientific Advisory Committee on Alternative Toxicological Methods Meeting Meeting Materials

September 2, 2020

Presentation Abstracts and Background Materials

• Session 1: ICCVAM – Past, Present, Future (Wednesday, September 2)
• Session 2a: Fostering International Partnerships (Wednesday, September 2)
• Session 2b: Moving Away from Animal-based Antibodies (Wednesday, September 2)
• Session 3: Curating and Characterizing Data for Alternative Methods Use (Thursday, September 3)
• Session 4: Computational Resources (Thursday, September 3)

Public Comments

Agenda Topic	Name, Affiliation, Sponsorship	Technical and Scientific Public Comments
ICCVAM – Past, Present and Future Fostering International Partnerships Moving Away from Animal-based Antibodies Curating and Characterizing Data for Alternative Method Use Computational Resources	Vicki Katrinak, Humane Society of the United States and Gillian Lyons, Humane Society Legislative Fund	Public comment received August 26, 2020

Scientific Advisory Committee on Alternative Toxicological Methods Meeting Presentations

September 2, 2020

September 2, 2020

ICCVAM: Past, Present, and Future

• 20 Years of Scientific Accomplishments
  Emily Reinke, PhD, U.S. Department of Defense
• Implementing the Strategic Roadmap
  Nicole Kleinstreuer, PhD, NIEHS/NTP
• NTP Approaches to Assessment of Dermal Hypersensitivity: Using Alternative Methods to Predict Skin Sensitization
  Dori Germolec, PhD, NIEHS/NTP
• Measuring Success of 3Rs Initiatives
  Suzanne Fitzpatrick, PhD, U.S. Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition
• The Strategic Roadmap: What Lies on the Horizon?
  Warren Casey, PhD, NIEHS/NTP

Fostering International Partnerships

• International Partner Updates
  Anna Lowit, PhD, U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs
• FDA, ICH, and the 3Rs
  Paul Brown, PhD, FDA Center for Drug Evaluation and Research
• Nonanimal Test Methods for Hazard Classification – Update on UN GHS Activities
  Janet Carter, PhD, Occupational Safety and Health Administration

Moving Away from Animal-based Antibodies

• COVID-19 Therapeutic Development with Synthetic Antibody Technology
  Sachdev Sidhu, PhD, University of Toronto

September 3, 2020

Curating and Characterizing Data for Alternative Methods Use

• Incorporating Variability in Animal Studies into Regulatory Frameworks and NAM Assessment
  Nicole Kleinstreuer, PhD, NIEHS/NTP
• Quantitative Variability in Repeat Dose Toxicity Studies: Implications for Scientific Confidence in New Approach Methodologies
  Katie Paul-Friedman, PhD, EPA Office of Research and Development
• Machine Learning in Toxicology: Towards Intelligent Access to the Content of Research
  Robert Patton, PhD, Oak Ridge National Laboratory
• Stem Cells and Genomics for Precision Cardiovascular Medicine
  Joseph Wu, MD, PhD, Stanford University School of Medicine
  (This is a large presentation and will take a few moments to download)

Computational Resources

• Introduction
  Nicole Kleinstreuer, PhD, NIEHS/NTP
• Integrated Chemical Environment (ICE) and In Vitro to In Vivo Extrapolation (IVIVE)
  Shannon Bell, PhD, ILS (contractor supporting NICEATM)
• Collaborative Modeling Project for Predicting Acute Oral Toxicity (CATMoS)
  Kamel Mansouri, PhD, ILS (contractor supporting NICEATM)
• Toxicokinetic and Toxicological Based Geospatial Risk Mapping
  Kyle Messier, PhD, NIEHS/NTP
  

Federal Register Notices

May 21, 2020

• Federal Register notice: PDF HTML

ICCVAM Public Forum Meeting Materials

May 21, 2020

Federal Register Notices

February 21, 2020

• Federal Register notice: PDF HTML

NTP Board of Scientific Counselors Meeting Meeting Materials

February 21, 2020

• Evolving the Paradigm: In Vivo to In Vitro Extrapolation
• Understanding Human Exposure to Nanoplastics/Microplastics: Novel Agents Bring Novel Challenges
• Hypertensive Disorders of Pregnancy and Environmental Exposures: Disease as a Toxicology Focus
• NTP Studies of Per- and Poly-fluoroalkyl Substances: Understanding Human Translation

Public Comments

Agenda Topic	Name, Affiliation, Sponsorship	Technical and Scientific Public Comments
NTP Studies of Per- and Poly-fluoroalkyl Substances: Understanding Human Translation	Joseph Manuppello, on behalf of the Physicians Committee for Responsible Medicine	Public comment received Feb. 24, 2020

NTP Board of Scientific Counselors Meeting Presentations

February 21, 2020

• Introduction to Meeting Agenda
  
• Evolving the Paradigm: In Vivo to In Vitro Extrapolation
• Understanding Human Exposure to Nanoplastics/ Microplastics: Novel Agents Bring Novel Challenges
• Hypertensive Disorders of Pregnancy and Environmental Exposures: Disease as a Toxicology Focus
• NTP Studies of Per- and Poly-fluoroalkyl Substances: Understanding Human Translation

Peer Review of the Draft NTP Technical Reports on the Toxicology and Carcinogenesis Studies of 2-Hydroxy-4-methoxybenzophenone and Perfluorooctanoic Acid Final Documents

December 12, 2019

Final Reports: 2-Hydroxy-4-methoxybenzophenone and Perfluorooctanoic Acid

Federal Register Notices

December 12, 2019

• Federal Register notice: PDF HTML

Peer Review of the Draft NTP Technical Reports on the Toxicology and Carcinogenesis Studies of 2-Hydroxy-4-methoxybenzophenone and Perfluorooctanoic Acid Meeting Materials

December 12, 2019

Charge

• 2-Hydroxy-4-methoxybenzophenone
• Perfluorooctanoic Acid

Draft Technical Report

• TR-597: 2-Hydroxy-4-methoxybenzophenone (CASRN 131-57-7) Administered in Feed to Sprague Dawley (Hsd:Sprague Dawley® SD®) Rats and B6C3F1/N Mice
• TR-598: Perfluorooctanoic Acid (CASRN 335-67-1) Administered in Feed to Sprague Dawley (Hsd:Sprague Dawley® SD®) Rats

Data Tables for Peer Review

• TR-597: Data for 2-Hydroxy-4-methoxybenzophenone
• TR-598: Data for Perfluorooctanoic Acid

Public Comments

Agenda Topic	Name, Affiliation, Sponsorship	Technical and Scientific Public Comments
Toxicology and Carcinogenesis Studies of 2-Hydroxy-4-methoxybenzophenone	Joe DiNardo, Private Citizen	Public comment received Nov. 19, 2019
Toxicology and Carcinogenesis Studies of Perfluorooctanoic Acid	Oyebode A. Taiwo, M.D., M.P.H., on behalf of the 3M Company	Public comment received  Nov. 19, 2019 Cover letter received Nov. 19, 2019
Toxicology and Carcinogenesis Studies of Perfluorooctanoic Acid	Alexis Temkin, Ph.D., on behalf of Environmental Working Group	Public comment received Nov. 20, 2019
Toxicology and Carcinogenesis Studies of Perfluorooctanoic Acid	Jason Dadakis, Orange County Water District	Public comment received Nov. 20, 2019

Related Links

• Testing Status of 2-Hydroxy-4-methoxybenzophenone
• Testing Status of Perfluorooctanoic acid

Peer Review of the Draft NTP Technical Reports on the Toxicology and Carcinogenesis Studies of 2-Hydroxy-4-methoxybenzophenone and Perfluorooctanoic Acid Presentations

December 12, 2019

• Meeting Format
• Introduction to Draft Reports and Charge to the Panel
  • Presentation and Charge
• Peer Review of Health Effect Areas
• A. Toxicology and Carcinogenesis Studies of 2-Hydroxy-4-methoxybenzophenone
  • Presentation
  • Reviewer Questions
• B. Toxicology and Carcinogenesis Studies of Perfluorooctanoic Acid
• Presentation
• Reviewer Questions

Federal Register Notices

September 19, 2019

• Federal Register notice: PDF HTML

Scientific Advisory Committee on Alternative Toxicological Methods Meeting Meeting Materials

September 19, 2019

US Strategic Roadmap: New Approaches to Validation

Presentation Abstracts: Introduction and EPA Activities

Presentation Abstracts: International Activities

Background Materials

• EPA Issue Paper - Evaluation of a Proposed Approach to Refine Inhalation Risk Assessment for Point of Contact Toxicity: A Case Study Using a New Approach Methodology (NAM)
• OECD Guidance Document on the Reporting of Defined Approaches to be Used Within Integrated Approaches to Testing and Assessment
• US Strategic Roadmap Website

New Approach Methodologies: Computational Tools

Presentation Abstracts

Background Materials

• Integrated Chemical Environment
• Casey et al. 2018. Evaluation and optimization of pharmacokinetic models for in vitro to in vivo extrapolation of estrogenic activity for environmental chemicals. Environ Health Perspect https://ehp.niehs.nih.gov/doi/10.1289/ehp1655
• Alberga et al. 2019. Prediction of acute oral systemic toxicity using a multifingerprint similarity approach. Toxicol Sci 167(2):484-495.
• Kleinstreuer et al. 2018. Predictive models for acute oral systemic toxicity: A workshop to bridge the gap from research to regulation. Comput Toxicol 8:21-24.
• Ring et al. 2019. Consensus modeling of median chemical intake for the U.S. population based on predictions of exposure pathways. Environ Sci Toxicol 53(2):719-732.
• Dionisio et al. 2018. The Chemical and Products Database, a resource for exposure-relevant data on chemicals in consumer products. Sci Data 5:180125.
• Phillips et al. 2017. High-throughput screening of chemicals as functional substitutes using structure-based classification models. Green Chem 19(4):1063-1074.
• Sobus et al. 2017. Integrating tools for non-targeted analysis research and chemical safety evaluations at the US EPA. J Expo Sci Environ Epidem 28:411-426.
• EPA Fact Sheet: Rapid Chemical and Dose Research

New Approach Methodologies: Translational Impact and Human Relevance of Microphysiological Systems

Presentation Abstracts

Background Materials

• Ewart et al. 2017. Navigating tissue chips from development to dissemination: A pharmaceutical industry perspective. Exp Biol Med 242(16):1579-1585.
• Low and Tagle. 2017. Tissue chips - innovative tools for drug development and disease modeling. Lab Chip 17(18):3026-3036.
• Science vol. 364, issue 6444: Special issue on "Organoids"
  • Purnell and Lavine. 2019. Approximating organs. Science 364(6444):946-947.
  • Shahbazi et al. 2019. Self-organization of stem cells into embryos: A window on early mammalian development. Science 364(6444):948-951.
  • Tuveson and Clevers. 2019. Cancer modeling meets human organoid technology. Science 364(6444):952-955.
  • Takebe and Wells. 2019. Organoids by design. Science 364(6444):956-959.
  • Park et al. 2019. Organoids-on-a-chip. Science 364(6444):960-965.
• NCATS webpage: About Tissue Chip
• NCATS webpage: Tissue Chip Initiatives & Projects
• McAleer et al. 2019. On the potential of in vitro organ-chip models to define temporal pharmacokinetic-pharmacodynamic relationships. Sci Rep 9(1):9619.
• Sakolish et al. 2018. Technology transfer of the microphysiological systems: A case study of the human proximal tubule chip. Sci Rep 8(1):14882.
• Mina et al. 2019. Assessment of drug-induced toxicity biomarkers in the brain microphysiological system (MPS) using targeted and untargeted molecular profiling. Front Big Data https://doi.org/10.3389/fdata.2019.00023
• McAleer et al. 2019. Multi-organ system for the evaluation of efficacy and off-target toxicity of anticancer therapeutics. Sci Transl Med 11(497)pii: eaav1386.

Public Comments

Agenda Topic	Name, Affiliation, Sponsorship	Technical and Scientific Public Comments
US Strategic Roadmap: New Approaches to Validation	Jessica Ryman-Rasmussen, PhD, DABT, American Petroleum Institute	Public comment received Sept. 11, 2019
US Strategic Roadmap: New Approaches to Validation New Approach Methodologies: Computational Tools New Approach Methodologies: Translational Impact and Human Relevance of Microphysiological Systems	Vicki Katrinak, Humane Society of the United States and Gillian Lyons, Humane Society Legislative Fund	Public comment received Sept. 12, 2019
New Approach Methodologies: Translational Impact and Human Relevance of Microphysiological Systems	Elizabeth Baker, Physicians Committee for Responsible Medicine	Public comment received Sept. 12, 2019

Scientific Advisory Committee on Alternative Toxicological Methods Meeting Presentations

September 19, 2019

September 19, 2019

US Strategic Roadmap: New Approaches to Validation

• Evaluation of a Proposed Approach to Refine the Inhalation Risk Assessment for Point of Contact Toxicity: A Case Study Using a New Approach Methodology
  Monique Perron, PhD, U.S. Environmental Protection Agency
• OECD Activities to Increase the Utility and Uptake of AOPs in Regulatory Contexts Across Countries
  Bob Diderich, Organisation for Economic Co-operation and Development
• Antibodies and Non-antibody Affinity Reagents Generated Using Animal-free Technologies, for Use in Research and Diagnostics
  João Barroso, European Union Reference Laboratory for Alternatives to Animal Testing

New Approach Methodologies: Computational Tools

• Balancing Machine Learning and Mechanistic Modeling
  Nicole Kleinstreuer, PhD, NIEHS/NTP
• Collaborative Acute Toxicity Modeling Suite
  Kamel Mansouri, PhD, ILS
• New Approach Methodologies for Exposure from EPA's ExpoCast Project
  Kristin Isaacs, PhD, U.S. Environmental Protection Agency

September 20, 2019

New Approach Methodologies: Translational Impact and Human Relevance of Microphysiological Systems

• Introduction
  Brian Berridge, PhD, NIEHS/NTP
• The NIH Microphysiological Systems Program: Tissue Chips for Drug Safety and Efficacy Studies
  Danilo Tagle, PhD, and Lucie Low, PhD, National Center for Advancing Translational Sciences
• Advancing Regulatory Science by Innovation: In Vitro Microphysiological Systems
  Suzanne Fitzpatrick, PhD, U.S. Food and Drug Administration
• Beyond 3-D Models: Building Confidence in Microphysiological Models
  Szczepan Baran, PhD, Novartis

Peer Review of Draft NTP Technical Reports on the Prenatal Developmental Toxicity Studies of
Tris(chloropropyl) Phosphate (TCPP), 4-Methylcyclohexanemethanol (MCHM), Vinpocetine, and Dimethylaminoethanol Bitartrate (DMAE) Final Documents

July 31, 2019

Final Reports: Tris(chloropropyl) Phosphate (TCPP), 4-Methylcyclohexanemethanol (MCHM), Vinpocetine, and Dimethylaminoethanol Bitartrate (DMAE)

Federal Register Notices

July 31, 2019

• Federal Register notice: PDF HTML
• Amended notice PDF HTML

Peer Review of Draft NTP Technical Reports on the Prenatal Developmental Toxicity Studies of
Tris(chloropropyl) Phosphate (TCPP), 4-Methylcyclohexanemethanol (MCHM), Vinpocetine, and Dimethylaminoethanol Bitartrate (DMAE) Meeting Materials

July 31, 2019

Charge

Draft Technical Reports

Prenatal Developmental Toxicity Studies of:

• DART-01: Tris(chloropropyl) Phosphate (CASRN 13674-84-5) in Sprague Dawley (Hsd:Sprague Dawley SD) Rats (Gavage Studies)
• DART-02: 4-Methylcyclohexanemethanol (CASRN 34885-03-5) in Sprague Dawley (Hsd:Sprague Dawley SD) Rats (Gavage Studies)
• DART-03: Vinpocetine (CASRN 42971-09-5) in Sprague Dawley (Hsd:Sprague Dawley SD) Rats and New Zealand White (Hra:NZW SPF) Rabbits (Gavage Studies)
• DART-04: Dimethylaminoethanol Bitartrate (CASRN 5988-51-2) in Sprague Dawley (Hsd:Sprague Dawley SD) Rats (Gavage Studies)

Data Tables for Peer Review

• DART-01: Data for NTP Prenatal Developmental Toxicity Studies of
  Tris(chloropropyl) Phosphate (TCPP)
• DART-02: Data for NTP Prenatal Developmental Toxicity Studies of
  4-Methylcyclohexanemethanol (MCHM)
• DART-03: Data for NTP Prenatal Developmental Toxicity Studies of
  Vinpocetine
• DART-04: Data for NTP Prenatal Developmental Toxicity Studies of
  Dimethylethanolamine Bitartrate (DMAE)

Related Links

• Testing Status of Tris(chloropropyl) Phosphate (TCPP)
• Testing Status of of 4-Methylcyclohexanemethanol (MCHM)
• Testing Status of of Vinpocetine
• Testing Status of Dimethylethanolamine Bitartrate (DMAE)
• Areas of Research: West Virginia Chemical Spill (MCHM)
• Areas of Research: Botanical Dietary Supplements (Vinpocetine)

Peer Review of Draft NTP Technical Reports on the Prenatal Developmental Toxicity Studies of
Tris(chloropropyl) Phosphate (TCPP), 4-Methylcyclohexanemethanol (MCHM), Vinpocetine, and Dimethylaminoethanol Bitartrate (DMAE) Presentations

July 31, 2019

• Meeting Format
• Introduction to Draft Reports and Charge to the Panel
  • Presentation
• A. Prenatal Developmental Toxicity Studies of Tris(Chloropropyl) Phosphate
  • Presentation
• B. Prenatal Developmental Toxicity Studies of 4-Methylcylohexanemethanol
  • Presentation
• C. Prenatal Developmental Toxicity Studies of Vinpocetine
  • Presentation
• D. Prenatal Developmental Toxicity Studies of Dimethylaminoethanol Bitartrate
  • Presentation

Federal Register Notices

June 17, 2019

• Federal Register notice: PDF HTML

NTP Board of Scientific Counselors Meeting Meeting Materials

June 17, 2019

Strategic Realignment

Translation as a Scientific Framework: Human Relevance (Part 2)

• Cancer Driver Mutations in Experimental Rodents and Prediction for Human Cancer
• Geospatial Human Health Exposure Science Connections to Toxicology

New NTP Programs: Health Effects Innovations

• Cardiovascular Hazard Assessment in Environmental Toxicology
  • Evaluating Cardiotoxicity Potential: Translational Approaches and Models
• Developmental Neurotoxicity Modeling
• Re-Envisioning Carcinogenicity Assessment at NTP

Converging on Cancer Workshop

Contract Concept: Genetic Toxicology Testing in Support of NTP

Report on Peer Review of Draft NTP Monograph on Sarin

NTP Board of Scientific Counselors Meeting Presentations

June 17, 2019

• Report from the NTP Director
• Strategic Realignment
  • Update and Recap of February 2019 BSC Meeting
  • Agency Portfolios in Support of NTP
    • NIOSH
    • FDA/NCTR
    • NIEHS/DNTP
    • NCATS
• Translation as a Scientific Framework: Human Relevance (Part 2)
• Introduction to Session
• Cancer Driver Mutations in Experimental Rodents and Prediction of Human Cancer
• Geospatial Human Health Exposure Science Connections to Toxicology
• New NTP Programs: Health Effects Innovations
  
  • Cardiovascular Hazard Assessment in Environmental Toxicology
    
    • Evaluating Cardiotoxicity Potential: Translational Approaches and Models
  • Developmental Neurotoxicity Modeling
  • Re-Envisioning Carcinogenicity Assessment at NTP
• Contract Concept: Genetic Toxicology Testing in Support of NTP
• Converging on Cancer Workshop
• Report on Peer Review of Draft NTP Monograph on Sarin

ICCVAM Public Forum Final Documents

May 23, 2019

• Read article about meeting (NIEHS Environmental Factor newsletter, July 2019)

Federal Register Notices

May 23, 2019

• Federal Register notice: PDF HTML

ICCVAM Public Forum Meeting Materials

May 23, 2019

ICCVAM Public Forum Presentations

May 23, 2019

Welcome and Introductions: Emily Reinke, U.S. Department of Defense, ICCVAM Co-chair

ICCVAM Roadmap and Implementation Plan - Progress Update: Anna Lowit, EPA, ICCVAM Co-chair

NICEATM Update: Nicole Kleinstreuer, NIEHS

Re-envisioning Toxicity Assessment @NTP: Warren Casey, NIEHS

FDA Activities: Suzanne Fitzpatrick, FDA

The NIH Microphysiological Systems Program: Bo Yeon Lee, NCATS

EPA OPP and OPPT Updates: Steven Snyderman, EPA

USDA Animal Welfare Information Center: Kristina Adams, USDA

U.S. Air Force 711th Human Performance Wing - Application of NAMs: Laura Stolle and Lisa Sweeney, Air Force Research Laboratories

U.S. Army Engineer Research and Development Center Update: Natalia Garcia-Reyero Vinas, ERDC

Predictive Toxicology at U.S. Army CCDC CBC: Kyle Glover, CCDC CBC

Department of the Interior Alternative Toxicology Test Methods Activities: Jessica Leet, Department of the Interior

Measurement Assurance Tools - Application to Alternative Test Methods: Elijah Petersen, National Institute of Standards and Technology

OECD Test Guidelines Programme Update: Wanda Hall, EPA

NIEHS SBIR/STTR Program and Toxicity Screening, Testing, and Modeling: Lingamanaidu Ravichandran, NIEHS

ICCVAM Public Forum Videos

May 23, 2019

Videocast recording on NIH VideoCasting and Podcasting website
Approximately 4 hrs 40 min – requires Adobe Flash installed and Java Script enabled

ICCVAM Public Forum Final Documents

May 23, 2019

• Read article about meeting (NIEHS Environmental Factor newsletter, July 2020)

Federal Register Notices

May 23, 2019

• Federal Register notice: PDF HTML

ICCVAM Public Forum Meeting Materials

May 23, 2019

ICCVAM Public Forum Presentations

May 23, 2019

Welcome: Anna Lowit, EPA, and Emily Reinke, U.S. Department of Defense, ICCVAM Co-chair

Reflections on 20 Years of ICCVAM: Linda Birnbaum, NIEHS

ICCVAM Workgroup Updates: Warren Casey, NIEHS

NICEATM Update: Nicole Kleinstreuer, NIEHS

Update on FDA Activities on Alternative Methods: Suzanne Fitzpatrick, FDA

IATA for Developmental Neurotoxicity: Mamta Behl, NIEHS

Update on Alternatives Research at EPA: Rusty Thomas, EPA Office of Research and Development

EPA Office of Pesticide Programs: Monique Perron, EPA Office of Pesticide Programs

Update from EPA/OSCPP/OPPT: James Cox and Todd Stedeford, EPA Office of Pollution Prevention and Toxics

USDA Animal Welfare Information Center: Jessie Kull, USDA

59MDW Science and Technology Overview and Upcoming Toxicology Projects: Amber Mallory, 59th Medical Wing, Joint Base San Antonio

OSHA Update to ICCVAM: Deana Holmes and Janet Carter, Occupational Safety and Health Administration

NCATS Update on Tox21 Activities: Anton Simeonov, National Center for Advancing Translational Sciences, National Institutes of Health

Measurement Science Activities Under ICCVAM: Elijah Petersen, National Institute of Standards and Technology

OECD Test Guidelines Programme Update: Wanda Hall, EPA

ICCVAM Public Forum Videos

May 23, 2019

Videocast recording on NIEHS website

The recording includes two videos:

• Morning session (3 hrs, 30 min)
• Afternoon session (2 hrs, 41 min)

Federal Register Notices

April 29, 2019

• Federal Register notice: PDF HTML
• Federal Register notice: PDF HTML

Workshop: Converging on Cancer Meeting Materials

April 29, 2019

Federal Register Notices

February 15, 2019

• Federal Register notice: PDF HTML

NTP Board of Scientific Counselors Meeting Meeting Materials

February 15, 2019

NTP Board of Scientific Counselors Meeting Presentations

February 15, 2019

• Update on the Strategic Realignment and Introduction to Meeting
  
• The Changing Toxicology Landscape: Challenges and the Future of Risk Assessment
  • John D. Piacentino
  • William Slikker, Jr.
  • Gina Solomon
  • William Cibulas
  • Syril D. Pettit
  • Fiona Sewell
  • Russell Thomas

Peer Review of the Draft NTP Monograph on the Systematic Review of Evidence of Long-Term Neurological Effects Following Acute Exposure to the Organophosphorus Nerve Agent Sarin Final Documents

February 4, 2019

• Final Monograph (Prepublication Copy)

Federal Register Notices

February 4, 2019

• Federal Register notice: PDF HTML
• Amended notice PDF HTML

Peer Review of the Draft NTP Monograph on the Systematic Review of Evidence of Long-Term Neurological Effects Following Acute Exposure to the Organophosphorus Nerve Agent Sarin Meeting Materials

February 4, 2019

Draft Monograph
Related Information

Peer Review of the Draft NTP Monograph on the Systematic Review of Evidence of Long-Term Neurological Effects Following Acute Exposure to the Organophosphorus Nerve Agent Sarin Presentations

February 4, 2019

• Meeting Format
• Introduction to Draft Monograph
  • Presentation
• Charge to the Panel
• Peer Review of Health Effect Areas
• A. Changes in Cholinesterase Levels 
  • Presentation
  • Animal Studies - Reviewer questions
  • Human Studies - Reviewer questions
• B. Visual and Ocular Effects
  • Presentation
  • Animal Studies - Reviewer questions
  • Human Studies - Reviewer questions
• C. Learning, Memory, and Intelligence
  • Presentation
  • Animal Studies - Reviewer questions
  • Human Studies - Reviewer questions
• D. Nervous System Morphological and Histological Changes
  • Presentation
  • Animal Studies - Reviewer questions
  • Human Studies - Reviewer questions
• E. Other Outcomes That Did Not Reach Hazard Conclusions
  • Presentation
  • Reviewer questions
• F. Integration of Animal and Human Evidence for Reaching Hazard Categorization
• Presentation
• Reviewer questions

Federal Register Notices

December 12, 2018

• Federal Register notice: PDF HTML

NTP Board of Scientific Counselors Meeting Meeting Materials

December 12, 2018

DNTP Strategic Realignment: Translation as a Scientific Framework

• Translating Science to Support Decisions
• Overview of Genomic Studies on Rodent Tumors and its Translational Relevance

CLARITY-BPA Research Program

• Integration Report Strategy 

NTP Board of Scientific Counselors Meeting Presentations

December 12, 2018

• Report from the NTP Director
• NTP Updates
• Update on DNTP’s Strategic Realignment
• DNTP Strategic Realignment: Translation as a Scientific Framework
• Introduction to Session
• Translating Science to Support Decisions
  • Overview of Assessing Health Effects Evidence
  • Literature Scoping and Evidence Mapping Approaches
  • Integrating Literature Analysis into the Research Pipeline
• Overview of Genomic Studies on Rodent Tumors and its Translational Relevance
• CLARITY-BPA Research Program
  • Integration Report Preparation Update

Webinar Series on the Utility of Zebrafish Models for Toxicology Presentations

October 25, 2018

• Robert Tanguay, Ph.D., Distinguished Professor of Molecular Toxicology, Department of Environmental and Molecular Toxicology, Oregon State University
  Presentation: AHR Gene Duplication

NTP Board of Scientific Counselors Meeting Final Documents

October 9, 2018

Final Monographs

• Antimony Trioxide
  • Appendices
  • Supplemental Materials
• Helicobacter pylori (Chronic Infection)

Federal Register Notices

October 9, 2018

• Federal Register notice: PDF HTML

NTP Board of Scientific Counselors Meeting Meeting Materials

October 9, 2018

Reports on Peer Reviews for the Report on Carcinogens

• Helicobacter pylori
• Antimony Trioxide

Revised Draft Monographs

• Revised Draft Report on Carcinogens Monograph on Antimony Trioxide
  • Appendices
  • Supplemental Materials
• Revised Draft Report on Carcinogens Monograph on Helicobacter pylori (Chronic Infection)

NTP Board of Scientific Counselors Meeting Presentations

October 9, 2018

• Strategic Realignment Update
• BSC’s Perspective for NTP Regarding Strategic Realignment
• Reports on Peer Reviews for the Report on Carcinogens
• Helicobacter pylori
• Antimony Trioxide

Federal Register Notices

October 5, 2018

• Federal Register notice: PDF HTML

Peer Review of the Draft Report on Carcinogens Monograph on Night Shift Work and Light at Night Meeting Materials

October 5, 2018

Charge

Draft RoC Monograph

• Night Shift Work and Light at Night
• Appendix A
• Appendix B
• Appendix C
• Appendix D
• Appendix E
• Appendix F
• Appendix G

Related Links

• NTP Review of Shift Work at Night, Light at Night, and Circadian Disruption

Peer Review of the Draft Report on Carcinogens Monograph on Night Shift Work and Light at Night Presentations

October 5, 2018

• Meeting Format
• Draft RoC Monograph: Objectives and Methods
  • Presentation
• Charge to the Panel
• Public Comments
  
  • Oral Public Comments from Martin Moore-Ede, Circadian
• Peer Review of Cancer Evaluation
  • A. Introduction and Exposure Light at Night and Night Shift Work: Circadian Disruption Studies 
  • B. Human Breast Cancer Studies
  • C. Other Human Cancer Studies
  • D. Cancer Studies in Experimental Animals
  • E. Mechanistic and Other Relevant Data
  • F. Evidence Integration and Preliminary Listing Recommendations
• Draft RoC Substance Profiles
  • Presentation

 

Webinar Series on the Utility of Zebrafish Models for Toxicology Presentations

September 27, 2018

• Michael Carvan, Ph.D., Shaw Professor, School of Freshwater Sciences, University of Wisconsin-Milwaukee
  Presentation: Transgenerational Inheritance

Federal Register Notices

September 5, 2018

• Federal Register notice: PDF HTML

Scientific Advisory Committee on Alternative Toxicological Methods Meeting Meeting Materials

September 5, 2018

September 5, 2018

Overview of US Strategic Roadmap and Goal: Connect End Users with the Developers of New Approach Methodologies

• US Strategic Roadmap Website
• EPA TSCA Strategy
• FDA Predictive Toxicology Strategy
• Implementation Plan Homepage
• Bibliography of all papers related to the implementation plans
• Strickland J et al. 2018. Status of acute toxicity testing requirements and data uses by U.S. regulatory agencies. Reg Toxicol Pharmacol 94:183-196.
• Hamm J et al. 2017. Alternative approaches for identifying acute systemic toxicity: moving from research to regulatory testing. Toxicology In Vitro 41:245-259.
• Clippinger AJ et al. 2018. Alternative approaches for acute inhalation toxicity testing to address global regulatory and non-regulatory data requirements: An international workshop report. Toxicol In Vitro 48:53-70.
• Daniel AB et al. 2018. International regulatory requirements for skin sensitization testing. Regul Toxicol Pharmacol 95:52-65.
• Hoffman S et al. 2018. Non-animal methods to predict skin sensitization (I): the Cosmetics Europe database. Crit Rev Toxicol 48(5):344-358.
• Kleinstreuer NC et al. 2018 Multivariate models for prediction of human skin sensitization hazard. J Appl Toxicol 37(3):347-360.
• Strickland J et al.  2017. Multivariate models for prediction of human skin sensitization hazard. J Appl Toxicol 37(3):347-360.
• Zang Q et al. 2017. In silico prediction of physicochemical properties of environmental chemicals using molecular fingerprints and machine learning. J Chem Inf Modeling 57:36-49.
• Zang Q et al. 2017. Prediction of skin sensitization potency using machine learning approaches. J Appl Toxicol 37(7):792-805.
• Strickland J et al. 2016. Integrated decision strategies for skin sensitization hazard. J Appl Toxicol 36(9):1150-62.
• EPA's Guidance on NAMs for Skin Sensitization and Dermal LD50 Waiver

Anticipated Science and Technology & Microphysiological Systems

• Ewart et al. 2017. Navigating tissue chips from development to dissemination: A pharmaceutical industry perspective. Exp Biol Med Oct;242(16):1579-1585.

US Strategic Roadmap Goal: Foster the Use of Efficient, Flexible, and Robust Practices to Establish Confidence in New Methods

• Update to ICCVAM’s “Validation and Regulatory Acceptance of Toxicological Test Methods”
• OECD Perspective on Test Methods Validation
  • OECD GD34
  • ICCVAM Guidelines for the Nomination and Submission of New, Revised, and Alternative Test Methods (NIH Publication No. 03-4508; 2003)
  • Validation and Regulatory Acceptance of Toxicological Test Methods
  • Strickland J et al. 2018. Status of acute toxicity testing requirements and data uses by U.S. regulatory agencies. Reg Toxicol Pharmacol 94:183-196.
  • Daniel AB et al. 2018. International regulatory requirements for skin sensitization testing. Regul Toxicol Pharmacol 95:52-65.

Moving Beyond Animal Data as the Gold Standard

• Marshall et al. 2018 Recommendations toward a human pathway-based approach to disease research. Drug Discov Today S1359-6446(17)30473-7.
• Kleinstreuer et al. 2018. Non-animal methods to predict skin sensitization: an assessment of defined approaches. Crit Rev Toxicol 48(5):359-374.
• Luechtefeld et al. 2018. Machine Learning of Toxicological Big Data Enables Read-Across Structure Activity Relationships (RASAR) Outperforming Animal Test Reproducibility Toxicological Sciences, https://doi.org/10.1093/toxsci/kfy152
• OECD Test No. 492

September 6, 2018

US Strategic Roadmap Goal: Encourage the Use and Adoption of New Methods and Approaches by Federal Agencies and Regulated Industry

• EPA Interim Science Policy: Use of Alternative Approaches for Skin Sensitization as a Replacement for Laboratory Animal Testing. https://www.regulations.gov/document?D=EPA-HQ-OPP-2016-0093-0090.
• Casati et al. 2017. ICATM position on the standardisation of defined approaches for skin sensitization testing to support regulatory use and international adoption. Archives of Toxicology 92(2):611-617.
• Clippinger et al. 2018. Alternative approaches for acute inhalation toxicity testing to address global regulatory and non-regulatory data requirements: An international workshop report.Toxicol In Vitro 48:53-70.
• Kleinstreuer et al. 2018. Predictive Models for Acute Oral Systemic Toxicity: A Workshop to Bridge the Gap from Research to Regulation. Computational Toxicology https://doi.org/10.1016/j.comtox.2018.08.002.

Future Directions

• Monticello TM et al. 2017. Current nonclinical testing paradigm enables safe entry to First-In-Human clinical trials: The IQ consortium nonclinical to clinical translational database. Toxicol Appl Pharmacol. 334:100-109.
• CEBS
• ICE
• Plunkett et al. 2015. Challenges in Using the ToxRefDB as a Resource for Toxicity Prediction Modeling. Reg Toxicol Pharmacol 72:610-614.
• Truong L et al. 2018. Predicting in vivo effect levels for repeat-dose systemic toxicity using chemical, biological, kinetic and study covariates. Arch Toxicol. Feb;92(2):587-600.

Public Comments

Agenda Topic	Name, Affiliation, Sponsorship	Technical and Scientific Public Comments
Overview of US Strategic Roadmap and Goal: Connect End-users with the Developers of New Approach Methodologies Anticipated Science and Technology – Microphysiological Systems US Strategic Roadmap Goal: Foster the Use of Efficient, Flexible, and Robust Practices to Establish Confidence in New Methods Moving Beyond Animal Data as the Gold Standard US Strategic Roadmap Goal: Encourage the Use and Adoption of New Methods and Approaches by Federal Agencies and Regulated Industry	Dr. Catherine Willett, Humane Society of the United States and Patricia L. Bishop, MSc, Humane Society International	Public comment received Aug. 29, 2018
US Strategic Roadmap and Goal Anticipated Science and Technology of Microphysiological Systems Moving Beyond Animal Data as the Gold Standard	Dr. Esther Haugabrooks, Mr. Joseph Manuppello, and Ms. Kristie Sullivan, MPH	Public comment received Aug. 30, 2018

Scientific Advisory Committee on Alternative Toxicological Methods Meeting Presentations

September 5, 2018

September 5, 2018

• Overview of US Strategic Roadmap and Goal: Connect End-users with the Developers of New Approach Methodologies
  • Public Comment
  • SACATM Discussion
• Anticipated Science and Technology – Microphysiological Systems
  • Public Comment
  • SACATM Discussion
• US Strategic Roadmap Goal: Foster the Use of Efficient, Flexible, and Robust Practices to Establish Confidence in New Methods
  • Update to ICCVAM’s “Validation and Regulatory Acceptance of Toxicological Test Methods”
  • OECD Perspective on Test Methods Validation
  • Public Comment
  • SACATM Discussion
• Moving Beyond Animal Data as the Gold Standard
• Public Comment
• SACATM Discussion

September 6, 2018

• US Strategic Roadmap Goal: Encourage the Use and Adoption of New Methods and Approaches by Federal Agencies and Regulated Industry
  • Oral Public Comment from Richard Becker
  • SACATM Discussion
• Future Directions
• Gaining Access to Large Quantities of Standardized Animal Testing Data: Considerations, Challenges, and Are There Truly Insurmountable Barriers?
• SACATM Discussion

NTP Board of Scientific Counselors Meeting Final Documents

June 20, 2018

Final Reports: Cell Phone Radiation: GSM and CDMA (Rats), Cell Phone Radiation: GSM and CDMA (Mice)

Federal Register Notices

June 20, 2018

• Federal Register notice: PDF HTML

NTP Board of Scientific Counselors Meeting Meeting Materials

June 20, 2018

Strategic Realignment: Translational Toxicology

Examples from NTP's Portfolio

• NTP Synthetic Turf/Recycled Tire Crumb Rubber Research

• Studies of Cell Phone Radiofrequency Radiation - Report on March 26-28, 2018 Peer Review of NTP Technical Reports

• Follow-up Studies of RFR

• Activities on Bisphenols 

• Evaluation of Bisphenol Analogues

• REACT Program for Per- and Polyfluoroalkyl Substances

Public Comments

Agenda Topic	Name, Affiliation, Sponsorship	Technical and Scientific Public Comments
Studies of Cell Phone Radiofrequency Radiation	Annie Sasco, Private Citizen	Public comment received June 1, 2018 (document resubmitted on June 11, 2018)
Studies of Cell Phone Radiofrequency Radiation	P.K. Mahesh, Private Citizen	Public comment received June 10, 2018
Studies of Cell Phone Radiofrequency Radiation	Environmental Working Group	Public comment received June 12, 2018
Studies of Cell Phone Radiofrequency Radiation	Phonegate Alert	Public comment received June 12, 2018

NTP Board of Scientific Counselors Meeting Presentations

June 20, 2018

• Report of the NIEHS/NTP Director
• Report from NTP Associate Director
• Strategic Realignment: Translational Toxicology
• Examples from NTP’s Portfolio
• NTP Synthetic Turf/Recycled Tire Crumb Rubber Research
• Studies of Cell Phone Radiofrequency Radiation
• Report on March 26-28, 2018 Peer Review of NTP Technical Reports
• Oral Public Comments from Annie Sasco
• Follow-up Studies of RFR
• Activities on Bisphenols
• CLARITY-BPA Research Program: Peer Review of Core Study and Next Steps 
• Evaluation of Bisphenol Analogues
• REACT Program for Per- and Polyfluoroalkyl Substances

ICCVAM Public Forum Final Documents

May 24, 2018

• Read article about meeting (NIEHS Environmental Factor newsletter, July 2018)

Federal Register Notices

May 24, 2018

•   PDF HTML

ICCVAM Public Forum Meeting Materials

May 24, 2018

ICCVAM Public Forum Presentations

May 24, 2018

Welcome from ICCVAM Co-chairs: Anna Lowit, Environmental Protection Agency (EPA) and Emily Reinke, Department of Defense (DoD)

U.S. Strategic Roadmap for Alternative Approaches

• Overview of the Strategic Roadmap: Warren Casey, National Institute of Environmental Health Sciences (NIEHS)
• Roadmap Implementation Plans
• Ocular and Dermal Irritation: Jill Merrill, Food and Drug Administration (FDA)
• Acute Systemic Toxicity: Nicole Kleinstreuer, NIEHS
• Skin Sensitization: Nicole Kleinstreuer, NIEHS

International Activities: Nicole Kleinstreuer, NIEHS

FDA Updates

• FDA Predictive Toxicology Roadmap: Suzanne Fitzpatrick, FDA
• Introduction to the Medical Device Development Tool Program: Jennifer Goode, FDA

Tox21 Update: Richard Paules, NIEHS

EPA Updates

• Office of Pesticide Programs: Garland Waleko, EPA
• Office of Pollution Prevention and Toxics: Louis Scarano, EPA

Department of Defense: Emily Reinke, DoD

Department of Agriculture: Carol Clarke, USDA

Department of the Interior: Barnett Rattner, Department of the Interior

National Institute of Standards and Technology: Elijah Petersen, National Institute of Standards and Technology

National Institutes of Health: Warren Casey, NIEHS

Public Comments

• People for the Ethical Treatment of Animals (received May 11)
• Physicians Committee for Responsible Medicine (received May 11)
• White Coat Waste Project/New England Anti-Vivisection Society (received May 17)
  Supplemental documentation
• The Humane Society of the United States (received May 24)

ICCVAM Public Forum Videos

May 24, 2018

Videocast recording on NIH VideoCasting and Podcasting website
Approximately 4 hrs 30 min – requires Adobe Flash installed and Java Script enabled

Peer Review of the Draft NTP Research Report on CLARITY-BPA Core Study Final Documents

April 26, 2018

Final Report: Clarity-BPA

Federal Register Notices

April 26, 2018

• Federal Register notice: PDF HTML

Peer Review of the Draft NTP Research Report on CLARITY-BPA Core Study Meeting Materials

April 26, 2018

Draft Research Report

• RR-09: CLARITY-BPA Core Study

Data Tables and Supplemental Appendices for Peer Review

• RR-09: Data Tables and Supplemental Appendices

Related Links

• Bisphenol A Research Program
• Testing Status of Bisphenol A

Public Comments

Name, Affiliation, Sponsorship	Technical and Scientific Public Comments
Timothy Farner, Private Citizen	Public comment received March 18, 2018
Jovan Leyva, Private Citizen	Public comment received March 22, 2018
Devan Campbell, Private Citizen	Public comment received April 2, 2018
Davis Reardon, University of Georgia, Environmental Health Science	Public comment received April 3, 2018
Katie Kearns, University of Georgia	Public comment received April 6, 2018
Joseph Laakso, on behalf of the Endocrine Society	Public comment received April 9, 2018
Jacob Siracusa, University of Georgia Athens	Public comment received April 9, 2018

Related Links

• Testing Status of Bisphenol A
• CLARITY-BPA Program

Peer Review of the Draft NTP Research Report on CLARITY-BPA Core Study Presentations

April 26, 2018

• Meeting Format
• Overall CLARITY-BPA Program
• Charge to the Panel
• Overview of CLARITY-BPA Core Study Design
• CLARITY-BPA Core Study Findings
• Oral Public Comments from Laura Vandenberg
• Reviewer Questions
• CLARITY-BPA Core Study Draft Scientific Interpretations

Peer Review of the Draft NTP Research Report on CLARITY-BPA Core Study Videos

April 26, 2018

Some browsers may experience play back issues when accessing these videos. We are working to resolve this issue. Videos may take some minutes to display depending on the size of the video and your Internet connection.

Videos and Closed Captioning

April 26, 2018

Workshop: Predictive Models for Acute Oral Systemic Toxicity Final Documents

April 11, 2018

• Workshop report (Computational Toxicology)
• Article about the workshop (NIEHS Environmental Factor newsletter, March 2016)

Federal Register Notices

April 11, 2018

•   PDF HTML

Workshop: Predictive Models for Acute Oral Systemic Toxicity Meeting Materials

April 11, 2018

Workshop: Predictive Models for Acute Oral Systemic Toxicity Presentations

April 11, 2018

Opening Session

Welcome and Introductions
Nicole Kleinstreuer, NIEHS/NICEATM

Implementation of Non-animal Approaches for Acute Systemic Toxicity
Grace Patlewicz, U.S. Environmental Protection Agency (EPA) National Center for Computational Toxicology

Amended TSCA: EPA's Strategic Plan to Promote the Development and Implementation of Alternative Test Methods
Louis Scarano, EPA Office of Pollution Prevention and Toxics (OPPT)

Regulatory Needs and Decision Contexts for Acute Oral Systemic Toxicity Data
Emily Reinke, U.S. Department of Defense (DoD)

Rat Oral Acute Toxicity Database and Variability
Agnes Karmaus, ILS

Collaborative Modeling Efforts for the Acute Oral Systemic Toxicity Endpoints
Kamel Mansouri, ILS

In Silico Approaches for Acute Oral Toxicity: Session 1

NTP Collaboration on Modeling Acute Systemic Oral Toxicity: Results and Ideas
Eugene Muratov, University of North Carolina, Chapel Hill

Modeling Quantitative Acute Oral Systemic Toxicity Based on a k-Nearest Neighbor (k-NN) Algorithm
Alessandra Roncaglioni, Instituto di Ricerche Farmacologiche "Mario Negri"

Practical Considerations for Estimation of Oral Rat LD50
Todd Martin, EPA Office of Research and Development

UL Cheminformatics Suite
Thomas Luechtefeld, Underwriters Laboratories

Mechanistic Profiling and Mentored Machine Learning: Application to Acute Toxicity
Dan Wilson, The Dow Chemical Company

In Silico Approaches for Acute Oral Toxicity: Session 2

Multitask Deep Learning Modelling of Rodent Acute Toxicity
Alexey Zakharov, National Center for Advancing Translational Sciences

Leadscope Predictive Models for Acute Oral Systemic Toxicity
Glenn Myatt, Leadscope, Inc.

A Clustering-based QSAR Model for Acute Oral Systemic Toxicity
Zhen Zhang, Dow Agrosciences

Consensus Approach for Modeling Acute Systemic Oral Toxicity and LD50 Data Using Machine Learning and In Silico Approaches
Ahmed Sayed, Rosettastein Consulting

Predicting Five Rat Acute Toxicity Endpoints with ANNE Models
Michael Lawless, Simulations Plus, Inc.

Wrap-up of Day One
Donald Cronce, DoD

End User Applications

Overview of the U.S. Strategic Roadmap
Anna Lowit, EPA Office of Pesticide Programs (OPP)

Perspective on the U.S. Army's Uses for Predictive Models of Acute Oral Toxicity
Lyle Burgoon, U.S. Army Engineer Research and Development Center

End User Applications: OECD Landscape
Kristie Sullivan, Physicians Committee for Responsible Medicine

Predictive Models for Acute Oral Systemic Toxicity Workshop: End User Application
Jeffery Gearhart, U.S. Air Force School of Aerospace Medicine

End User Applications: EPA Office of Pesticide Programs
Edward Odenkirchen, EPA OPP

Acute Oral Systemic Toxicity Modeling: End User Applications
Lawrence Milchak, 3M Corporation

End User Applications: EPA Office of Pollution Prevention and Toxics
Louis Scarano, EPA OPPT

Breakout Group Sessions

Charge to the Breakout Groups
Nicole Kleinstreuer, NIEHS/NICEATM

Summary of Breakout Group A: Practical Applications
David Allen, ILS

Summary of Breakout Group B: Interpretation, Characterization, and Extension
Grace Patlewicz, EPA NCCT

Closing Remarks
Nicole Kleinstreuer, NIEHS/NICEATM

Workshop: Predictive Models for Acute Oral Systemic Toxicity Videos

April 11, 2018

Webcast recordings on NIH Videocast website:

• Day 1 (6 hours, 23 minutes)
• Day 2 (3 hours, 14 minutes)

Peer Review of the Draft NTP Technical Reports on Cell Phone Radiofrequency Radiation Final Documents

March 26, 2018

Final Reports: Cell Phone Radiation: GSM and CDMA (Rats), Cell Phone Radiation: GSM and CDMA (Mice)

Federal Register Notices

March 26, 2018

• Federal Register notice: PDF HTML

Peer Review of the Draft NTP Technical Reports on Cell Phone Radiofrequency Radiation Meeting Materials

March 26, 2018

Charge

Draft Technical Reports

• TR-595: NTP Studies of Cell Phone Radiofrequency Radiation (Rats)
• TR-596: NTP Studies of Cell Phone Radiofrequency Radiation (Mice)

Supplemental Materials

• Capstick et al. A radio frequency radiation exposure system for rodents based on reverberation chambers. IEEE Trans Electromagn Compat. 2017; 59(4):1041-1052 https://doi.org/10.1109/TEMC.2017.2649885
• Gong et al. Life-time dosimetric assessment for mice and rats exposed in reverberation chambers for the two-year NTP cancer bioassay study on cell phone radiation. IEEE Trans Electromagn Compat. 2017; 59(6):1798-1808 https://doi.org/10.1109/TEMC.2017.2665039
• Wyde et al. Effect of cell phone radiofrequency radiation on body temperature in rodents: Pilot studies of the National Toxicology Program's reverberation chamber exposure system. Bioelectromagnetics. 2018. http://onlinelibrary.wiley.com/doi/10.1002/bem.22116/full

Data Tables for Peer Review

• TR-595: Data for NTP Studies of Cell Phone Radiofrequency Radiation (Rats)
• TR-596: Data for NTP Studies of Cell Phone Radiofrequency Radiation (Mice)

Related Links

• Testing Status of Cell Phone Radiation: CDMA
• Testing Status of Cell Phone Radiation: GSM
• Areas of Research: Cell Phones

Public Comments

Name, Affiliation, Sponsorship	Technical and Scientific Public Comments
Giorgio Cinciripini, Rete Noelettrosmog Italia	Public comment received February 3, 2018
Michael Peleg, Israel	Public comment received February 5, 2018
Eval Hartogs, Ramat Gan, Israel	Public comment received February 9, 2018
P.K. Mahesh, Bangalore, Karnataka, India	Public comment received February 14, 2018
Ernest Lippert, Private Citizen	Public comment received February 16, 2018
Ronald Kostoff, Private Citizen	Public comment received February 20, 2018
Bernard Feldman, University of Missouri-St. Louis	Public comment received February 20, 2018
Sue Newton, Private Citizen	Public comment received February 21, 2018
Lorien Davy, Private Citizen	Public comment received February 27, 2018
Bernard Feldman, University of Missouri-St. Louis	Public comment received March 6, 2018
Tom Whitney, Private Citizen	Public comment received March 12, 2018
Rakuram Gandhi, Private Citizen	Public comment received March 12, 2018
Environmental Health Trust	Public comment received March 12, 2018
Annie Sasco, Private Citizen	Public comment received March 12, 2018
Barbara Stagno, on behalf of Citizens for Alternatives to Animal Research and Experiments	Public comment received March 12, 2018
Chung Chou, C-K. Chou Consulting	Public comment received March 12, 2018
Cindy Russell, Private Citizen	Public comment received March 12, 2018
Drew Fountain, on behalf of the National Antenna and Tower Safety Center	Public comment received March 12, 2018
George Carlo, Science and Public Policy Institute	Public comment received March 12, 2018
Joel Moskowitz, University of California, Berkeley	Public comment received March 12, 2018
Lagroye, Ecole Pratique des Hautes Etudes, PSL reseach University	Public comment received March 12, 2018
Lennart Hardell, The Environment and Cancer Research Foundation	Public comment received March 12, 2018
Magda Havas, Trent University	Public comment received March 12, 2018
Marc Arazi, on behalf of Association Alerte Phonegate	Public comment received March 12, 2018
Mona Nilsson, on behalf of the Swedish Radiation Protection Foundation	Public comment received March 12, 2018
Olga Naidenko, on behalf of Environmental Working Group	Public comment received March 12, 2018
Robert Morris, on behalf of Environmental Health Trust	Public comment received March 12, 2018
Ronald Melnick, Private Citizen	Public comment received March 12, 2018
Young Ahn, on behalf of the EMF Research Committee of Korean Institute of Electromagnetic Engineering and Science (KIEES) of South Korea	Public comment received March 12, 2018
Meredith Crosby, Private Citizen	Public comment received April 6, 2018
P.K. Mahesh, Bangalore, Karnataka, India	Public comment received April 10, 2018
Richard Firth, Private Citizen	Public comment received April 12, 2018

Additional Comments
Comment received February 4, 2018
Comments received February 21, 2018
Comments received February 22, 2018
Comments received February 23, 2018
Comment received February 24, 2018
Comments received February 26, 2018
Comments received March 1, 2018
Comment received March 5, 2018
Comments received March 7, 2018
Comments received March 8, 2018
Comment received March 9, 2018
Comment received March 10, 2018
Comments received March 11, 2018
Comments received March 12, 2018

Peer Review of the Draft NTP Technical Reports on Cell Phone Radiofrequency Radiation Presentations

March 26, 2018

March 26, 2018

• Meeting Format for Day 1
• Charge to Panel 1
• Nomination, NTP’s Considerations for Toxicological Evaluation of Radiofrequency Radiation Exposure in Rodents, and Background on Exposure System Selection
• Reverberation Chamber System for Radiofrequency Radiation Exposures
• Dosimetric Considerations for Rodents Exposed in Reverberation Chambers
• Reverberation Chamber System Validation and Verification
• Thermal Pilot Studies, Reproduction Studies in Rats and Exposure Level Selections for NTP’s Studies
• Oral Public Comments from Theodora Scarato
• Oral Public Comments from Devra Davis
  

March 27, 2018

• Meeting Format for Days 2 and 3
• NTP's Toxicology and Carcinogenesis Studies: Experimental Design, Statistical  Analyses, and Hazard Determinations
• NTP's Toxicology and Carcinogenesis Studies: Genetic Toxicology Testing
• NTP's Toxicology and Carcinogenesis Studies: Pathology Evaluation Process
• Charge to Panel 2
• Oral Public Comments from Theodora Scarato
• Oral Public Comments from Devra Davis
• Oral Public Comments from Marc Arazi
• Oral Public Comments from Annie Sasco
• Oral Public Comments from Young Hwan Ahn
• Oral Public Comments from Ron Melnick
• Results of the NTP Studies of Cell Phone Radiofrequency Radiation in B6C3F1/N Mice

March 28, 2018

• Charge to Panel 2
• Results of the NTP Studies of Cell Phone Radiofrequency Radiation in Hsd: Sprague Dawley Rats
• Pathology Peer Review Process and Selected Lesions for the 2-Year Study of Cell Phone Radiofrequency Radiation in Rats

Peer Review of the Draft Report on Carcinogens Monograph on Antimony Trioxide Final Documents

January 24, 2018

Final Monograph

• Antimony Trioxide
  • Appendices
  • Supplemental Materials

Federal Register Notices

January 24, 2018

• Federal Register notice: PDF HTML

Peer Review of the Draft Report on Carcinogens Monograph on Antimony Trioxide Meeting Materials

January 24, 2018

• Charge
• Scientific review information

Draft RoC Monograph

• Antimony Trioxide
  
  • Appendices

Public Comments

Name, Affiliation, Sponsorship	Public Comments
Ahmed Mostafa, MD, Ryan Surmaitis, DO, Maricel Dela Cruz, DO, Michael Greenberg, MD, Muhammad Khalid, MD, Division of Medical Toxicology at Drexel University College of Medicine	Public commentreceived 01/09/2018
Caroline Braibant on behalf of the International Antimony Association	Public commentreceived 01/10/2018
Mark Carpels on behalf of Campine	Public commentreceived 01/10/2018

Peer Review of the Draft Report on Carcinogens Monograph on Antimony Trioxide Presentations

January 24, 2018

• Meeting Format
• Process for Preparing the Draft RoC Monograph on Antimony Trioxide and Charge
• Oral Comments:  Mrs. Rita Cortvrindt, Campine
• Properties and Human Exposure 
• Human Cancer Studies 
• Cancer Studies in Experimental Animals
• Disposition and Toxicokinetics
• Mechanistic and Other Relevant Data 
• Overall Cancer Evaluation
• Substance Profile

Federal Register Notices

January 23, 2018

• Federal Register notice: PDF HTML

ICCVAM Communities of Practice Webinar: Machine Learning in Toxicology - Fundamentals of Application and Interpretation Meeting Materials

January 23, 2018

ICCVAM Communities of Practice Webinar: Machine Learning in Toxicology - Fundamentals of Application and Interpretation Presentations

January 23, 2018

• Machine Learning in Toxicology: Fundamentals of Application and Interpretation
  Sean Ekins, Ph.D., D.Sc., Collaborations Pharmaceuticals, Inc.
• Machine Learning Models: Regulatory Application, Acceptance, and Implementation
  Nicole Kleinstreuer, Ph.D., National Institute of Environmental Health Sciences

Federal Register Notices

December 7, 2017

• Federal Register notice: PDF HTML

NTP Board of Scientific Counselors Meeting Meeting Materials

December 7, 2017

December 7, 2018

• US Strategic Roadmap: New Approaches to Evaluate the Safety of Chemicals and Medical Products
  • A Strategic Roadmap for Establishing New Approaches to Evaluate the Safety of Chemicals and Medical Products in the United States
  • Agencies' Implementation of Strategic Roadmap
  • NCATS Tissue Chip for Drug Screening Program
  • NIEHS Promoting Alternatives: SBIR IIb
• NTP Assessing Alternative Approaches
  • Integrated Testing Strategies for Assessing Developmental Neurotoxicity
  • NTP's Approaches to Assessment of Dermal Hypersensitivity
  • REACT Program
  • Office of Data Science
  • Integrated Chemical Environment
• Report on Peer Review of Draft Report on Carcinogens Monograph on Haloacetic Acid

December 8, 2017

• New Approaches to Hazard Characterization and Risk Assessment
  • Report on Peer Review of Draft NTP Approach to Genomic Dose-Response Modeling
  • Tox21 Phase 3: High-Throughput Transcriptomics and the S1500+ Initiative
  • ECHA Workshop: Accelerating the Pace for Risk Assessment
• Update on NTP Studies of Glyphosate

Public Comments

Agenda Topic	Name, Affiliation, Sponsorship	Public Comments
Report on Peer Review of Draft Report on Carcinogens Monograph on Haloacetic Acids	Judith Nordgren, On Behalf of Chlorine Chemistry Division of American Chemistry Council	Public comment received 11/29/2017

NTP Board of Scientific Counselors Meeting Presentations

December 7, 2017

December 7, 2017

• Report of the NIEHS/NTP Director
• US Strategic Roadmap: New Approaches to Evaluate the Safety of Chemicals and Medical Products
  • A Strategic Roadmap for Establishing New Approaches to Evaluate the Safety of Chemicals and Medical Products in the United States
  • Agencies' Implementation of Strategic Roadmap
  • Report of Scientific Advisory Committee on Alternative Toxicological Methods’ Discussions on US Strategic Roadmap
  • NCATS Tissue Chip for Drug Screening Program
  • NIEHS Promoting Alternatives: SBIR IIb
• NTP Assessing Alternative Approaches
  • Integrated Testing Strategies for Assessing Developmental Neurotoxicity
  • NTP's Approaches to Assessment of Dermal Hypersensitivity
  • REACT Program
  • Office of Data Science
  • Integrated Chemical Environment
  • Report on Peer Review of Draft Report on Carcinogens Monograph on Haloacetic Acids
  • Report on Peer Review Panel on Dietary Zinc, 2,3-Butanedione, and p-Chloro-α,α,α-trifluorotoluene
• Report from NTP Associate Director

December 8, 2017

• New Approaches to Hazard Characterization and Risk Assessment
  • Tox21 Phase 3: High-Throughput Transcriptomics and the S1500+ Initiative
  • Report on Peer Review of Draft NTP Approach to Genomic Dose-Response Modeling
• ECHA Workshop: Accelerating the Pace for Risk Assessment
  
• Update on NTP Studies of Glyphosate

Public Meeting: Alternative Test Methods to Reduce Vertebrate Animal Testing Under the Toxic Substances Control Act Videos

November 2, 2017

View recording of plenary session webcast on National Institutes of Health Videocast site

Peer Review of Draft NTP Approach to Genomic Dose-Response Modeling Final Documents

October 23, 2017

• Final approach

Federal Register Notices

October 23, 2017

• Federal Register notice: PDF HTML

Peer Review of Draft NTP Approach to Genomic Dose-Response Modeling Meeting Materials

October 23, 2017

• Charge
• Draft NTP Approach to Genomic Dose-Response Modeling
• Webinar series

Public Comments

Agenda Topic	Name, Affiliation, Sponsorship	Public Comments
Genomic Dose-Response Modeling	Janis E. Hulla, PhD, DABT, ATS, ERT, Senior Toxicologist and Regional Technical Expert for Toxicology, US Army Corps of Engineers – Sacramento District	Public comment received 08/31/2017
Genomic Dose-Response Modeling	Kan Shao, PhD, Assistant Professor, Department of Environmental and Occupational Health, School of Public Health, Indiana University	Public comment received 09/29/2017

Peer Review of Draft NTP Approach to Genomic Dose-Response Modeling Presentations

October 23, 2017

Monday, October 23, 2017

• Introduction
• Background on NTP’s Proposed Approach to Genomic Dose-Response Modeling and Panel Charge
• Genomic Dose Response: The BIG Picture
• Overview of the NC State Approach to Genomic Dose-Response Modeling
• Toxicogenomic Dose Response Analysis to Inform Risk Assessments
• An Automated Method Identifies Dose-Responsive Genes and Quantifies Points of Departure
• Overview of the NTP Proposed Approach to Genomic Dose-Response Modeling
• Some Pertinent Findings from MAQC Related to Reproducibility of Gene Expression
• NTP’s Proposed Approach to Filtering Unresponsive Genes

Tuesday, October 24, 2017

• Interpreting the Results of EPA Dose-Response Models
• Fitting Curves Using Non-Parametric Approaches
• NTP’s Proposed Approach to Curve Fitting and Determination of Feature Potency
• When is a Pathway Changed?
• Deriving Points of Departure Using Toxicogenomics for Chemical Risk Assessment
• NTP’s Proposed Approach to Estimating Gene Set Level Potencies
• Improving Study Designs for Quantifying Biological Potency with Genomics Data
• NTP’s Proposed Approach to Study Design for Genomic Dose-Response Modeling

Wednesday, October 25, 2017

• Using the AOP Framework to Aid in Gene Set Identification
• Application of Weighted Gene Co-Expression Network Analysis (WGCNA) to Dose Response Analysis
• NTP’s Proposed Approach to Biological Interpretation of Genomic Dose-Response Results

Final Recommendations

• Final Genomics Dose-Response Recommendations

Peer Review of Draft NTP Approach to Genomic Dose-Response Modeling Videos

October 23, 2017

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Videos and Closed Captioning

October 23, 2017

 

 

October 24, 2017

 

 

October 25, 2017

Federal Register Notices

September 18, 2017

• Federal Register notice: PDF HTML

Scientific Advisory Committee on Alternative Toxicological Methods Meeting Meeting Materials

September 18, 2017

September 18, 2017

• Overview of US Strategic Roadmap
  • US Strategic Roadmap Website
• Strategic Goal: Encourage Adoption and Use of New Approaches by Federal Agencies and Regulated Industries
  • Implementation of RISK21
• How Will ICCVAM Measure the Strategic Roadmap’s Success?
• Strategic Goal: Use of Timely, Flexible, and Robust Practices to Establish Confidence in New Methods
  
  • Establishing Confidence
  • Use of Tissue Chip by FDA
  • Data Sharing
  • NIH Translator

September 19, 2017

• Tri-Service Toxicology Consortium
• Tox21 Strategic Plan
• EPA’s Implementation of Lautenberg Chemical Safety Act
  • Lautenberg Chemical Safety Act
• Strategic Goal: Connect End-users with the Development of New Tools
  • Introduction
  • NIEHS SBIR Phase llb (PDF HTML)
• Implementation Topics
  • Introduction
• Implementation: Alternatives for Skin Sensitization Testing
• Implementation: Alternatives for Acute Systemic Toxicity Testing
• Implementation in Other Areas

Public Comments

Agenda Topic	Name, Affiliation, Sponsorship	Public Comments
Implementation Acute Systemic Toxicity	Dr. Yves Alarie, University of Pittsburgh	Public comment received 08/26/2017
Overview of US Strategic Roadmap	Odette Alexander, MS, Syngenta Crop Protection LLC	Public comment received 08/31/2017
Strategic Goal: Encourage Adoption and Use of New Approaches by Federal Agencies and Regulated Industries How Will ICCVAM Measure the Strategic Roadmap’s Success? Strategic Goal: Use of Timely, Flexible, and Robust Practices to Establish Confidence in New Methods Use of Tissue Chip by FDA Data Sharing Strategic Goal: Connect End Users with the Development of New Tools Implementation: Alternatives for Skin Sensitization Testing Implementation: Alternatives for Acute Systemic Toxicity Testing Implementation in Other Areas	Dr. Amy Clippinger, People for the Ethical Treatment of Animals	Public comment received 09/11/2017
Overview of US Strategic Roadmap Strategic Goal:  Encourage Adoption and Use of New Approaches by Federal Agencies and Regulated Industries Strategic Goal:  Connect end-users with the Development of New Tools Implementation in Other Areas	Dr. Norman C. Peterson, The North American 3Rs Collaborative	Public comment received 09/12/2017
Strategic Goal:  Encourage Adoption and Use of New Approaches by Federal Agencies and Regulated Industries	Tammy Drake, Center for Responsible Science	Public comment received 09/15/2017
Overview of US Strategic Roadmap Strategic Goal: Encourage Adoption and Use of New Approaches by Federal Agencies and Regulated Industries Strategic Goal: Connect end-users with the Development of New Tools Strategic Goal: Use of Timely, Flexible, and Robust Practices to Establish Confidence in New Methods	Vickie Katrinak and Dr. Lindsay Marshall, The Humane Society	Public comment received 09/18/2017

Scientific Advisory Committee on Alternative Toxicological Methods Meeting Presentations

September 18, 2017

September 18, 2017

• Overview of US Strategic Roadmap
• Strategic Goal: Encourage Adoption and Use of New Approaches by Federal Agencies and Regulated Industries
  • Implementation of RISK21
• How Will ICCVAM Measure the Strategic Roadmap’s Success?
• Strategic Goal: Use of Timely, Flexible, and Robust Practices to Establish Confidence in New Methods
  
  • Establishing Confidence
  • Use of Tissue Chip by FDA
  • Data Sharing
  • NIH Translator

September 19, 2017

• Agency Activities
  • Introduction
  • Tri-Service Toxicology Consortium
  • Tox21 Strategic Plan
  • EPA’s Implementation of Lautenberg Chemical Safety Act
• Strategic Goal: Connect End-users with the Development of New Tools
  • Introduction
  • NIEHS SBIR Phase llb
• Implementation of the Strategic Roadmap
  • Introduction
• Implementation: Alternatives for Skin Sensitization Testing
• Application of U.S. Strategic Roadmap . . . and How the North American 3R's Collaborative May Help
• Implementation: Alternatives for Acute Systemic Toxicity Testing and Other Areas

4th International Symposium on Systematic Review and Meta-Analysis of Laboratory Animal Studies Meeting Materials

August 24, 2017

• Meeting Flyer
• Final Program

Peer Review of the Draft RoC Monograph on Haloacetic Acids Found as Water Disinfection By-Products Final Documents

July 24, 2017

• Final monograph Appendices

Federal Register Notices

July 24, 2017

• Federal Register notice: PDF HTML

Peer Review of the Draft RoC Monograph on Haloacetic Acids Found as Water Disinfection By-Products Meeting Materials

July 24, 2017

• Charge
• Scientific review information

Draft RoC Monographs

• Haloacetic Acids Found as Water Disinfection By-Products
  • Appendices

Revised Draft Monograph

• Revised Draft Report on Carcinogens Monograph on Haloacetic Acids Found as Water Disinfection By-Products
  • Appendices

Public Comments

Name, Affiliation, Sponsorship	Public Comments
Tasha Stoiber, Ph.D., Senior Scientist, On behalf of Environmental Working Group	Public commentreceived 07/11/2017
Judith Nordgren, Chlorine Chemistry Division, On behalf of American Chemistry Council	Public commentreceived 07/14/2017

   

Peer Review of the Draft RoC Monograph on Haloacetic Acids Found as Water Disinfection By-Products Presentations

July 24, 2017

• Meeting Format
• Process for Preparing the Draft RoC Monograph on Haloacetic Acids Found as Water Disinfection By-Products
• Charge
• Properties and Exposure
• Studies in Experimental Animals
• Other Relevant Data
• Evaluation of HAAs as a Class or Subclass(es)
• Overall Cancer Evaluation
• Substance Profiles

NTP Technical Reports Peer Review Panel Final Documents

July 13, 2017

Final Reports: Dietary zinc, 2,3-Butanedione, and p-Chloro-α,α,α-trifluorotoluene

Federal Register Notices

July 13, 2017

• Federal Register notice: PDF HTML

NTP Technical Reports Peer Review Panel Meeting Materials

July 13, 2017

• Charge
• Draft Technical Reports
  • TR-592: Dietary Zinc [1]
  • TR-593: 2,3-Butanedione
  • TR-594: p-Chloro-α,α,α-trifluorotoluene

• Pathology, Body Weight, and Survival Tables for Peer Review
  • TR-592: Dietary Zinc [1]
  • TR-593: 2,3-Butanedione
  • TR-594: p-Chloro-α,α,α-trifluorotoluene

Public Comments

Agenda Topic	Name, Affiliation, Sponsorship	Public Comments
2,3-Butanedione	Anders Abelmann, On behalf of Cardno ChemRisk	Public comment received 07/06/2017

[1] Zinc carbonate basic (CAS No. 5263-02-5) was used as the dietary zinc source, and the formula and molecular weight shown are for zinc carbonate basic.

Related Links

• Testing Status of 2,3-Butanedione
• Testing Status of p-Chloro-α,α,α-trifluorotoluene
• Testing Status of Zinc Carbonate, Basic

NTP Technical Reports Peer Review Panel Presentations

July 13, 2017

• Charge
• Draft Technical Report on p-Chloro-α,α,α-trifluorotoluene (TR-594)
• Draft Technical Report on 2,3-Butanedione (TR-593)
• Draft Technical Report on Dietary Zinc (TR-592)

Federal Register Notices

June 29, 2017

• Federal Register notice: PDF HTML
• Amended notice PDF HTML

NTP Board of Scientific Counselors Meeting Meeting Materials

June 29, 2017

• Strategies for Studying Combined Exposures and Mixtures
• Where the Rubber Meets the Road: Update on the NTP Crumb Rubber Research Program
• Screening for Biological Activities of Concern in Consumer Products
• Transgenerational Inheritance of Health Effects: A State-of-the-Science Review
• A Roadmap for the Implementation of New Approaches for Safety Testing

Public Comments

Agenda Topic	Name, Affiliation, Sponsorship	Public Comments
Strategies for Studying Combined Exposures and Mixtures, Screening for Biological Activities of Concern in Consumer Products, Transgenerational Inheritance of Health Effects: A State-of-the-Science Review, A Roadmap for the Implementation of New Approaches for Safety Testing	Olga Naidenko, On Behalf of Environmental Working Group	Public comment received 06/20/2017
A Roadmap for the Implementation of New Approaches for Safety Testing	Elizabeth Baker and Kristie Sullivan, On Behalf of Physicians Committee for Responsible Medicine	Public comment received 06/21/2017
Screening for Biological Activities of Concern in Consumer Products	Alexander Hoepker, Ph.D., Private Citizen	Public comment received 06/26/2017
Where the Rubber Meets the Road: Update on the NTP Crumb Rubber Research Program	Jill Schilling, On Behalf of Safe Healthy Playing Fields Coalition	Public comment received 06/28/2017 Attachment 1 Attachment 2
Where the Rubber Meets the Road: Update on the NTP Crumb Rubber Research Program	Amy Stephan, On Behalf of Safe Healthy Playing Fields Coalition	Public comment received 06/28/2017 Attachment 1 Attachment 2 Attachment 3 Attachment 4 Attachment 5
Where the Rubber Meets the Road: Update on the NTP Crumb Rubber Research Program	Dr. Christi Davis, Washington Alliance for Nontoxic Play and Athletic Fields	Public comment received 06/29/2017 Attachment 1
Where the Rubber Meets the Road: Update on the NTP Crumb Rubber Research Program	Dr. Stephanie Fox-Rawlings, National Center for Health Research	Public comment received 06/29/2017

NTP Board of Scientific Counselors Meeting Presentations

June 29, 2017

• Report of the NIEHS/NTP Director
• Strategies for Studying Combined Exposures and Mixtures
• Where the Rubber Meets the Road: Update on NTP Crumb Rubber Research
• Screening for Biological Activities of Concern in Children's Products
• Report of the NTP Associate Director
• Transgenerational Inheritance of Health Effects: A State-of-the-Science Evaluation
• A Strategic Roadmap for the Implementation of New Approaches to Safety Evaluation

NTP Board of Scientific Counselors Meeting Videos

June 29, 2017

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Videos and Closed Captioning

June 29, 2017

Workshop: BioMed21 - A Human Pathway-based Approach to Disease and Medicine Final Documents

June 26, 2017

• Workshop report (Drug Discovery Today)
• Article about the workshop (NIEHS Environmental Factor newsletter, August 2017)

Workshop: BioMed21 - A Human Pathway-based Approach to Disease and Medicine Meeting Materials

June 26, 2017

• White paper
• Langley et al. 2015. Lessons from Toxicology: Developing a 21st-Century Paradigm for Medical Research. Environ Health Perspect 123(11):A268-A272
• Download article as PDF
  

Workshop: BioMed21 - A Human Pathway-based Approach to Disease and Medicine Presentations

June 26, 2017

Workshop Presentations (Human Toxicology Project Consortium website)

ICCVAM Public Forum Final Documents

May 23, 2017

Public Comments Submitted Before Meeting

• Comments on the Strategic Roadmap
• Physicians Committee for Responsible Medicine (May 12)
• Center for Responsible Science (May 17)
• Global In Vitro Validation In Silico Human (May 17)

Public Statements Presented During Meeting

• Elizabeth Baker (Physicians Committee for Responsible Medicine)
• Richard Becker (American Chemistry Council)
  Presentation: Challenges and Opportunities: Establishing Scientific Confidence for Specific Fit-for-purpose Use
• Amy Clippinger (People for the Ethical Treatment of Animals)
• Christine Rowen (GIVVISH)
  Presentation: GIVVISH: Streamlining Human-relevant Method Validation - A 21st Century Collaboration Platform
• Sue Leary (Alternatives Research and Development Foundation)

Federal Register Notices

May 23, 2017

• Federal Register notice: PDF HTML

ICCVAM Public Forum Meeting Materials

May 23, 2017

• Environmental Factor Newsletter article (June 2017)
• Link to Strategic Roadmap
  
• ICCVAM Committee Roster
• Roster with Contact Information

ICCVAM Public Forum Presentations

May 23, 2017

Presentations

Welcome from ICCVAM Co-Chairs: Abigail Jacobs, Food and Drug Administration (FDA) and Anna Lowit, Environmental Protection Agency (EPA)

Developing a Strategic Roadmap to Establish New Approaches for Evaluating the Safety of Chemicals and Medical Products in the United States: Warren Casey, National Institute of Environmental Health Sciences (NIEHS)

ICCVAM and ICCVAM Agency Updates

• ICCVAM Update: Anna Lowit, EPA
• Skin Sensitization Update: Nicole Kleinstreuer, NIEHS
• OECD Test Guidelines Programme Update: Wanda Hall, EPA, U.S. National Coordinator for the Test Guidelines Programme of the Organisation for Economic Co-operation and Development
• Globally Harmonized System for Classification and Labelling (GHS) Informal Working Group on Non-animal Testing: Joanna Matheson, Consumer Product Safety Commission
• Updates: National Toxicology Program Nigel Walker, NIEHS
• An Update from the Department of Defense for ICCVAM: LTC Marla Brunell, Department of Defense Human Performance, Training, and BioSystems Directorate
• Recent FDA 3Rs Efforts: Abigail Jacobs, FDA Center for Drug Evaluation and Research
• Reducing Hamster Usage in Leptospira Vaccine Potency Testing: Carol Clarke, Animal and Plant Health Inspection Service, U.S. Department of Agriculture
• EPA Office of Pesticide Programs Update: Garland Waleko, EPA
• TSCA Amendments: Gino Scarano, EPA
• National Library of Medicine: Bert Hakkinen, Office of Clinical Toxicology
• Tox21: A New Strategic Plan for Continued Leadership: Kevin Crofton, EPA
• Advancing Regulatory Science at FDA: Suzanne Fitzpatrick, FDA Center for Food Safety and Applied Nutrition
• NIH Tissue Chip Program: Updates: Lucie Low, National Center for Advancing Translational Sciences
• Measurement Assurance Tools and Potential Application to Alternative Test Methods: Elijah Peterson, National Institute of Standards and Technology
• Department of Transportation: An ICCVAM Update: Steve Hwang, Pipeline and Hazardous Materials Administration, Department of Transportation

ICCVAM Public Forum Videos

May 23, 2017

Webcast of the ICCVAM Public Forum: May 2017 (approx. 4 hr. and 50 min.)

Webinar Series on Using Informatics to Improve Data Analysis of Chemical Screening Assays Conducted in Zebrafish: A Review of Relevant Ontologies and Application of Reasoners Presentations

March 2, 2017

• Melissa Haendel, Ph.D., Director, Ontology Development Group, Department of Medical Informatics and Clinical Epidemiology, Oregon Health and Science University
  Presentation: A Review of Relevant Ontologies and Application of Reasoners

Webinar Series on the Utility of Zebrafish Models for Toxicology Presentations

March 2, 2017

• John Postlethwait, Ph.D., Professor of Biology, Institute of Neuroscience, University of Oregon
  Presentation: Genome Duplication

Webinar Series on Using Informatics to Improve Data Analysis of Chemical Screening Assays Conducted in Zebrafish: Ontologies 101 Presentations

February 16, 2017

• Lyle Burgoon, Ph.D., Leader, Bioinformatics and Computational Toxicology Group, U.S. Army Engineer Research and Development Center
  Presentation: Ontology 101: An Introduction

Webinar Series on Using Informatics to Improve Data Analysis of Chemical Screening Assays Conducted in Zebrafish: Introduction to Zebrafish Screening Presentations

February 2, 2017

• Nigel Walker, Ph.D., Deputy Division Director for Research, National Toxicology Program
  Presentation: An Overview of SEAZIT
• David Reif, Ph.D., Associate Professor, Bioinformatics Research Center and Center for Human Health and the Environment, Department of Biological Sciences, North Carolina State University
  Presentation: Using Informatics to Improve Data Analysis of Chemical Screening Assays Conducted in Zebrafish
• Jon Hamm, Ph.D., Senior Staff Toxicologist, Integrated Laboratory Systems, Inc.
  Presentation: SEAZIT: Current and Proposed Activities

ICCVAM Communities of Practice Webinar: Incorporating Chemical Information: Resources, Limitations, and Characterizing the Domain of Applicability for 21st Century Toxicity Testing Presentations

January 24, 2017

Characterizing, Navigating, and Modeling the Chemical Space Using Next-Generation Cheminformatics Methods
Denis Fourches, Ph.D., Department of Chemistry, Bioinformatics Research Center, North Carolina State University

Recent Cheminformatics Development at NCCT Applied to ER, AR, and Physicochemical Properties of Chemicals
Kamel Mansouri, Ph.D., National Center for Computational Toxicology, U.S. Environmental Protection Agency

NTP Board of Scientific Counselors Meeting Meeting Materials

December 14, 2016

Supplemental materials for events, meetings, and workshops prior to 2017 have been archived. These archived materials frequently include presentations, background materials, and public comments. Email us or use our contact form to request a list or copy of archived materials for the following meeting.

Scientific Advisory Committee on Alternative Toxicological Methods Meeting Meeting Materials

September 27, 2016

Supplemental materials for events, meetings, and workshops prior to 2017 have been archived. These archived materials frequently include presentations, background materials, and public comments. Email us or use our contact form to request a list or copy of archived materials for the following meeting.

Alternative Approaches for Acute Inhalation Toxicity to Address Global Regulatory and Non-regulatory Data Requirements Final Documents

September 22, 2016

• Workshop report (Toxicology In Vitro)

Alternative Approaches for Acute Inhalation Toxicity to Address Global Regulatory and Non-regulatory Data Requirements Presentations

September 22, 2016

• Presentations (PETA International Science Consortium website)

Webinar Series on Alternative Approaches for Acute Inhalation Toxicity: 21st Century Testing Approaches Final Documents

September 8, 2016

• Webinar series and workshop report (Toxicology In Vitro)

Webinar Series on Alternative Approaches for Acute Inhalation Toxicity: 21st Century Testing Approaches Presentations

September 8, 2016

• Kelly BéruBé, Ph.D., Cardiff University (PISC website)
• Dan Huh, Ph.D., University of Pennsylvania (PISC website)

Webinar Series on Alternative Approaches for Acute Inhalation Toxicity: 21st Century Testing Approaches Videos

September 8, 2016

• Webinar recording (YouTube)

Peer Review of the Draft NTP Monograph on Immunotoxicity Associated with Exposure to Perfluorooctanoic Acid (PFOA) or Perfluorooctane Sulfonate (PFOS) Final Documents

July 19, 2016

• Final monograph

Peer Review of the Draft NTP Monograph on Immunotoxicity Associated with Exposure to Perfluorooctanoic Acid (PFOA) or Perfluorooctane Sulfonate (PFOS) Meeting Materials

July 19, 2016

Supplemental materials for events, meetings, and workshops prior to 2017 have been archived. These archived materials frequently include presentations, background materials, and public comments. Email us or use our contact form to request a list or copy of archived materials for the following meeting.

Webinar Series on Alternative Approaches for Acute Inhalation Toxicity: Adverse Outcome Pathways Final Documents

July 12, 2016

• Webinar series and workshop report (Toxicology In Vitro)

Webinar Series on Alternative Approaches for Acute Inhalation Toxicity: Adverse Outcome Pathways Presentations

July 12, 2016

• Mathieu Vinken, Ph.D., Free University of Brussels (PISC website)
• Barbara Buckley, Ph.D., U.S. Environmental Protection Agency (PISC website)

Webinar Series on Alternative Approaches for Acute Inhalation Toxicity: Adverse Outcome Pathways Videos

July 12, 2016

• Webinar recording (YouTube)

Webinar Series on Alternative Approaches for Acute Inhalation Toxicity: GHS Additivity Approach to Classify Mixtures Based on Ingredient Toxicity Final Documents

June 28, 2016

• Webinar series and workshop report (Toxicology In Vitro)

Webinar Series on Alternative Approaches for Acute Inhalation Toxicity: GHS Additivity Approach to Classify Mixtures Based on Ingredient Toxicity Presentations

June 28, 2016

• Marco Corvaro, Ph.D., Dow AgroSciences (PISC website)

Webinar Series on Alternative Approaches for Acute Inhalation Toxicity: GHS Additivity Approach to Classify Mixtures Based on Ingredient Toxicity Videos

June 28, 2016

• Webinar recording (YouTube)

NTP Board of Scientific Counselors Meeting Meeting Materials

June 15, 2016

Supplemental materials for events, meetings, and workshops prior to 2017 have been archived. These archived materials frequently include presentations, background materials, and public comments. Email us or use our contact form to request a list or copy of archived materials for the following meeting.

Webinar Series on Alternative Approaches for Acute Inhalation Toxicity: State-of-the-science and Practical Application of In Silico Methods Final Documents

May 26, 2016

• Webinar series and workshop report (Toxicology In Vitro)

Webinar Series on Alternative Approaches for Acute Inhalation Toxicity: State-of-the-science and Practical Application of In Silico Methods Presentations

May 26, 2016

• Grace Patlewicz, Ph.D., U.S. Environmental Protection Agency (PISC website)
• Dan Wilson, Ph.D., The Dow Chemical Company

Webinar Series on Alternative Approaches for Acute Inhalation Toxicity: State-of-the-science and Practical Application of In Silico Methods Videos

May 26, 2016

• Webinar recording (YouTube)

ICCVAM Public Forum Final Documents

May 25, 2016

• Read article about meeting (NIEHS Environmental Factor newsletter, July 2016)

ICCVAM Public Forum Presentations

May 25, 2016

• ICCVAM Update
• NICEATM Update

ICCVAM Agency Updates

• Food and Drug Administration: Abigail Jacobs, Ph.D.
• National Institute of Standards and Technology: Elijah Petersen, Ph.D.
• Department of Defense: LTC Dawn Fitzhugh, V.M.D.
• National Institutes of Health/National Center for Advancing Translational Sciences Chemical Genomics Center: Anton Simeonov, Ph.D.
• NIEHS/NTP: Rick Paules, Ph.D.
• Environmental Protection Agency
  • Office of Pesticide Programs: Dr. Lowit
  • National Center for Computational Toxicology: Kevin Crofton, Ph.D.
  • Endocrine Disruptor Screening Program: Seema Schappelle, Ph.D.

Public Statements

• Kathy Archibald and Tamara Drake (Safer Medicines Trust and Center for Responsible Science)
• Aryenish Birdie and Elizabeth Baker (Physicians Committee for Responsible Medicine)
• George Bittner, Ph.D. (University of Texas as Austin; CertiChem, Inc.)
  Presentation: Proposed Test Battery for Estrogenic Activity
• Pascaline Clerc, Ph.D. (Humane Society of the United States)
• Amy Clippinger, Ph.D. (People for the Ethical Treatment of Animals)

ICCVAM Public Forum Videos

May 25, 2016

Webcast recording (total runtime 4:12:46)

Workshop: Addressing Challenges in the Assessment of Botanical Dietary Supplement Safety Meeting Materials

April 26, 2016

Supplemental materials for events, meetings, and workshops prior to 2017 have been archived. These archived materials frequently include presentations, background materials, and public comments. Email us or use our contact form to request a list or copy of archived materials for the following meeting.

Webinar Series on Alternative Approaches for Acute Inhalation Toxicity: State-of-the-science, Practical Application, and Dosimetry Considerations for In Vitro and Ex Vivo Methods Final Documents

April 26, 2016

• Webinar series and workshop report (Toxicology In Vitro)

Webinar Series on Alternative Approaches for Acute Inhalation Toxicity: State-of-the-science, Practical Application, and Dosimetry Considerations for In Vitro and Ex Vivo Methods Presentations

April 26, 2016

• Marianna Gaca, Ph.D., British American Tobacco (PISC website)
• Annie Jarabek, Ph.D., U.S. Environmental Protection Agency (PISC website)

Webinar Series on Alternative Approaches for Acute Inhalation Toxicity: State-of-the-science, Practical Application, and Dosimetry Considerations for In Vitro and Ex Vivo Methods Videos

April 26, 2016

• Webinar recording (YouTube)

NTP Board of Scientific Counselors Meeting Meeting Materials

April 11, 2016

Supplemental materials for events, meetings, and workshops prior to 2017 have been archived. These archived materials frequently include presentations, background materials, and public comments. Email us or use our contact form to request a list or copy of archived materials for the following meeting.

Webinar Series on Alternative Approaches for Acute Inhalation Toxicity: Current Testing Practices: Regulatory Requirements and Non-regulatory Testing Final Documents

March 29, 2016

• Webinar series and workshop report (Toxicology In Vitro)

Webinar Series on Alternative Approaches for Acute Inhalation Toxicity: Current Testing Practices: Regulatory Requirements and Non-regulatory Testing Presentations

March 29, 2016

• Jon Hotchkiss, Ph.D., The Dow Chemical Company (PISC website)
• Ian Indans, United Kingdom Chemicals Regulation Directorate (PISC website)

Webinar Series on Alternative Approaches for Acute Inhalation Toxicity: Current Testing Practices: Regulatory Requirements and Non-regulatory Testing Videos

March 29, 2016

• Webinar recording (YouTube)

Workshop: Shift Work at Night, Artificial Light at Night, and Circadian Disruption Final Documents

March 10, 2016

Workshop Report

• PubMed
• ScienceDirect

Workshop: Shift Work at Night, Artificial Light at Night, and Circadian Disruption Meeting Materials

March 10, 2016

Federal Register Notices

• Feb 2016
  • PDF
  • HTML
• March 2016 (amended notice)
• PDF
• HTML

Flyer
Speaker Information

Meeting Materials

• Session Abstract
• Appendix A: Overview of human studies: Cancer, biomarkers, and interventions
• Appendix B: Overview of experimental animal studies: Carcinogenicity
• Appendix C: Overview of animal studies: Non-cancer health outcome
• Appendix D: Overview of experimental animal studies: Non-cancer health outcome
• Appendix E: Meeting participants

Workshop: Shift Work at Night, Artificial Light at Night, and Circadian Disruption Videos

March 10, 2016

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Videos and Closed Captioning

Friday March 11, 2016

Discussion

 

In Vitro to In Vivo Extrapolation for High Throughput Prioritization and Decision Making Final Documents

February 17, 2016

• Workshop Report (Toxicology In Vitro)

In Vitro to In Vivo Extrapolation for High Throughput Prioritization and Decision Making Meeting Materials

February 17, 2016

• Presentation Abstracts
• Breakout Group Questions
• Poster Abstracts
• Speaker Biographies

In Vitro to In Vivo Extrapolation for High Throughput Prioritization and Decision Making Presentations

February 17, 2016

Workshop Presentations

Opening Session

• Welcome
  Warren Casey, NIEHS/NICEATM
• The EURL ECVAM Toxicokinetics Report and EURL ECVAM Strategy
  Alicia Paini, European Union Reference Laboratory for Alternatives to Animal Testing
• Workshop Background and Summaries of Webinars
  John Wambaugh, U.S. Environmental Protection Agency (EPA)

Session 1: Application in Risk Assessment: What Do We Need for Decision-making and Prioritization?

• Using In Vitro Data in Quantitative Risk Assessments (QRAs)
  Paul Price, EPA
• Interindividual Variability in High Throughput Risk Prioritization of Environmental Chemicals
  Caroline Ring, EPA
• Quantitative Considerations of Dose-Response for IVIVE
  Ted Simon, Ted Simon LLC
• Toxicokinetics in Risk Assessment: From Predictive Evaluations to Regulatory Testing
  Mike Bartels, The Dow Chemical Company
• Development and Application of Biologically Based Dose-Response Modeling for Pregnancy Conditions: Evaluation of Thyroid Active Chemical Exposure During Sensitive Life Stages
  Annie Lumen, U.S. Food and Drug Administration

Session 2: Metabolism and Excretion

• Strength and Limitations of In Vitro Xenobiotic Metabolism Assays and In Silico Models
  Stephen Ferguson, NIEHS
• In Silico Screening of Primary Clearance Mechanisms
  John Troutman, The Procter & Gamble Company
• In Vitro Models for Quantitative Prediction of Hepatobiliary Clearance
  Kim Brouwer, University of North Carolina at Chapel Hill

Session 3: In Silico Modeling

• Predictive Power of PBPK Modeling and In Silico/In Vitro-In Vivo Extrapolation Using GastroPlus™ and ADMET Predictor™ Software Tools
  Grazyna Fraczkiewicz, Simulations Plus, Inc.
• In Vitro In Vivo Extrapolation and its Applications in Predicting Pharmacokinetic Population Variability
  Alice Ke, SimCyp, a Certara Company

Summary Presentations

• Day 1 Wrap-up
  Barbara Wetmore, ScitoVation, LLC
• Breakout Group Summary

Webinar Materials

October 7: Setting the Stage: Purpose, Definitions, Scope, and Assumptions

Barbara Wetmore, Ph.D., The Hamner Institutes for Health Sciences

• October webinar slides
• Wetmore bio

November 4: Building Fit-for-purpose Pharmacokinetic Models

John Wambaugh, Ph.D., National Center for Computational Toxicology, U.S. Environmental Protection Agency

• Hidden on web page View November webinar recording (1 hour, 4 minutes; requires Adobe Connect plug-in)
• November webinar slides
• Wambaugh bio

December 3: The Role of Pharmacokinetic Model Evaluation

Lisa Sweeney, Ph.D., Naval Medical Research Unit Dayton and Jackson Foundation for the Advancement of Military Medicine

• Hidden on web page View December webinar recording (54 minutes; requires Adobe Connect plug-in)
• December webinar slides
• December webinar abstract
• Sweeney bio

January 6: Framework for Establishing an Internal Threshold of Toxicological Concern

Corie Ellison, Ph.D., Sharon Woods Innovation Center, The Procter & Gamble Company

• Hidden on web page View January webinar recording (56 minutes; requires Adobe Connect plug-in)
• January webinar slides
• January webinar abstract
• Ellison bio
  
  

NTP Technical Reports Peer Review Panel Final Documents

February 16, 2016

NTP Technical Reports Peer Review Panel Meeting Materials

February 16, 2016

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ICCVAM Communities of Practice Webinar: Fundamentals of Using Quantitative Structure-Activity Relationship Models and Read-across Techniques in Predictive Toxicology Presentations

January 26, 2016

• Fundamentals of QSAR Modeling: Basic Concepts and Applications
  Alex Tropsha, Ph.D., University of North Carolina at Chapel Hill
• Application of QSAR Principles in the Regulatory Environment: The U.S. EPA Chemicals Program
  Louis (Gino) Scarano, Ph.D., Office of Pollution Prevention and Toxics, U.S. Environmental Protection Agency

Webinar Series on In Vitro to In Vivo Extrapolation for High Throughput Prioritization and Decision Making: Framework for Establishing an Internal Threshold of Toxicological Concern Meeting Materials

January 6, 2016

Corie Ellison, Ph.D., Sharon Woods Innovation Center, The Procter & Gamble Company

• January webinar slides
• January webinar abstract
• Ellison bio

Peer Review of the Draft RoC Monograph on Selected Viruses Final Documents

December 17, 2015

• Final monographs: EBV, KSHV, HIV, HTLV-1, MCV
• NTP response to the peer review report

Peer Review of the Draft RoC Monograph on Selected Viruses Meeting Materials

December 17, 2015

Peer Review of the Draft RoC Monograph on Selected Viruses Presentations

December 17, 2015

Webinar Series on In Vitro to In Vivo Extrapolation for High Throughput Prioritization and Decision Making: The Role of Pharmacokinetic Model Evaluation Meeting Materials

December 3, 2015

Lisa Sweeney, Ph.D., Naval Medical Research Unit Dayton and Jackson Foundation for the Advancement of Military Medicine

• December webinar slides
• December webinar abstract
• Sweeney bio

NTP Board of Scientific Counselors Meeting Meeting Materials

December 1, 2015

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Webinar Series on In Vitro to In Vivo Extrapolation for High Throughput Prioritization and Decision Making: Building Fit-for-purpose Pharmacokinetic Models Meeting Materials

November 4, 2015

John Wambaugh, Ph.D., National Center for Computational Toxicology, U.S. Environmental Protection Agency

• November webinar slides
• Wambaugh bio

Webinar Series on In Vitro to In Vivo Extrapolation for High Throughput Prioritization and Decision Making: Setting the Stage: Purpose, Definitions, Scope, and Assumptions Meeting Materials

October 7, 2015

Barbara Wetmore, Ph.D., The Hamner Institutes for Health Sciences

• October webinar slides
• Wetmore bio

Alternative Approaches to Identifying Acute Systemic Toxicity: Moving from Research to Regulatory Testing Final Documents

September 24, 2015

Workshop report (Toxicology in Vitro)

Alternative Approaches to Identifying Acute Systemic Toxicity: Moving from Research to Regulatory Testing Presentations

September 24, 2015

Session 1: The Regulatory Landscape: When Is Acute Toxicity Data Required and How Is It Used?

U.S. Consumer Product Safety Commission
Joanna Matheson, Ph.D., Directorate for Health Sciences, U.S. Consumer Product Safety Commission

Acute Toxicity Testing: Office of Pesticide Programs
Elissa Reaves, Ph.D., Office of Pesticide Programs, U.S. Environmental Protection Agency (EPA)

Requirements and Evaluation of Toxicity Testing in the TSCA New Chemicals Program
Louis Scarano, Ph.D., Office of Pollution Prevention and Toxics, EPA

Session 2: State of the Science for Acute Toxicity Testing Methods

Alternative Methods for Acute Systemic Toxicity Testing
Rabea Graepel, Ph.D., Systems Toxicity Unit, European Union Reference Laboratory for Alternatives to Animal Testing

From QSAR to Big Data: Developing Mechanism-Driven Predictive Models for Animal Toxicity
Hao Zhu, Ph.D., Department of Chemistry, Rutgers University-Camden

Biokinetic Considerations in the Use of In Vitro Systems for Estimating Acute (Systemic) Toxicity
Bas Blaauboer, Institute for Risk Assessment Sciences, Utrecht University

NRC Report: Application of Modern Toxicology Approaches for Predicting Acute Toxicity for Chemical Defense
David Dorman, D.V.M., Ph.D., Department of Molecular Biosciences, North Carolina State University

Session 3: Case Studies

Vision for Animal-free Pesticide Formulation Assessments
Sean Gehen, Ph.D., Dow AgroSciences LLC

Predicting Acute Toxicity Hazard in the Absence of Experimental Data: Case Studies from the Alternatives Assessment Paradigm
Jay Tunkel, Ph.D., SRC, Inc.

Zebrafish Models for Human Organophosphorus Poisoning
Natalia Garcia-Reyero, Ph.D., U.S. Army Engineer R&D Center, U.S. Army Corps of Engineers

Session 4: Looking Ahead: Mechanisms and Adverse Outcome Pathways

Mechanisms of Acute Toxicity
Dan Wilson, Ph.D., The Dow Chemical Company

Computationally Predicted AOPs
Shannon Bell, Ph.D., Integrated Laboratory Systems, Inc.

High-throughput In Vitro Assays at NCATS
Menghang Xia, Ph.D., Division of Preclinical Innovation, National Center for Advancing Translational Sciences

Scientific Advisory Committee on Alternative Toxicological Methods Meeting Meeting Materials

September 2, 2015

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Peer Review of the Draft RoC Monograph on Cobalt and Certain Cobalt Compounds Final Documents

July 22, 2015

Peer Review of the Draft RoC Monograph on Cobalt and Certain Cobalt Compounds Meeting Materials

July 22, 2015

Peer Review of the Draft RoC Monograph on Cobalt and Certain Cobalt Compounds Presentations

July 22, 2015

NTP Technical Reports Peer Review Panel Meeting Final Documents

June 25, 2015

• Final Report: Pentabromodiphenyl ether mixture [DE–71 (technical grade)]

NTP Technical Reports Peer Review Panel Meeting Meeting Materials

June 25, 2015

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NTP Board of Scientific Counselors Meeting Meeting Materials

June 16, 2015

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ICCVAM Public Forum Final Documents

May 27, 2015

• Read article about meeting (NIEHS Environmental Factor newsletter, July 2015)
• Correction to Dr. Carol Clarke's (USDA) remarks about the NIH Office of Laboratory Animal Welfare Annual Report

ICCVAM Public Forum Presentations

May 27, 2015

• ICCVAM Update
  Anna Lowit, PhD, ICCVAM Co-Chair
• NICEATM Update
  Warren Casey, PhD, DABT, NICEATM Director

ICCVAM Agency Updates

• Department of Defense
  LTC Dawn Fitzhugh, VMD, MPH
• Department of Transportation
  Steve Hwang, PhD
• Environmental Protection Agency
  Dr. Lowit and Patience Browne, PhD
• Food and Drug Administration
  Abigail Jacobs, PhD
• National Institute of Environmental Health Sciences
  Nigel Walker, PhD, DABT
• National Library of Medicine
  Pertti Hakkinen, PhD
• National Institute of Standards and Technology
  Elijah Petersen, PhD

Public Comments

• Summary of written comments
  Dr. Casey
  • Amy Clippinger, PhD, and Kristie Sullivan (PETA/PCRM)
  • Jayanta Das, PhD (Florida International University)
  • Katherine Tsaioun, PhD, and Tamara Drake (Safer Medicines Trust/Center for Responsible Science)
• University of California, Berkeley
  Amy Kyle, PhD
• People for the Ethical Treatment of Animals
  Ashley DeCoux, PhD
  Follow-up comments submitted June 4
• Safer Medicines Trust/Center for Responsible Science
  Dr. Tsaioun
• Physicians Committee for Responsible Medicine
  Kristie Sullivan, MPH (phone)

ICCVAM Public Forum Videos

May 27, 2015

Webcast recording (total runtime 2:57:07)

Identifying Research Needs for Assessing Safe Use of High Intakes of Folic Acid Final Documents

May 11, 2015

Final monograph

Expert Panel report (Chapter 6 of final monograph)

Identifying Research Needs for Assessing Safe Use of High Intakes of Folic Acid Meeting Materials

May 11, 2015

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ICCVAM Communities of Practice Webinar: Reverse Toxicokinetics Presentations

January 27, 2015

Developing Reverse Toxicokinetic Models to Correlate In Vitro and In Vivo Activity
Dr. John Wambaugh, EPA National Center for Computational Toxicology

Incorporating Population Variability and Susceptible Subpopulations into Dosimetry for High-Throughput Toxicity Testing
Dr. Barbara Wetmore, The Hamner Institutes for Health Sciences

NTP Board of Scientific Counselors Meeting Meeting Materials

December 9, 2014

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Scientific Advisory Committee on Alternative Toxicological Methods Meeting Meeting Materials

September 16, 2014

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Scientific Workshop - Adverse Outcome Pathways: From Research to Regulation Final Documents

September 3, 2014

Group Discussion Summaries

• Breakout Group 1: The Process of Regulatory Acceptance
• Breakout Group 2: Using AOPs for Regulatory Decisions: Confidence and Criteria
• Breakout Group 3: Taking Qualitative AOPs to the Next (Quantitative) Level

Other Documents

• Workshop Report (Regulatory Toxicology and Pharmacology)
• Newsletter article: Adverse outcome pathway workshop generates enthusiasm and collaboration

Scientific Workshop - Adverse Outcome Pathways: From Research to Regulation Presentations

September 3, 2014

Workshop Presentations

Opening Session

• Welcome
  Warren Casey, NIEHS/NICEATM
• Innovation in Toxicology at NCATS
  Christopher Austin, U.S. National Center for Advancing Translational Sciences
• From Mode of Action to Adverse Outcome Pathways: Moving Towards Regulatory Applicability
  Bette Meek, University of Ottawa
• What is an AOP (and What ISN’T It?)
  Donna Mendrick, U.S. Food and Drug Administration (FDA)

Session 1: Building Upon Other Efforts

• AOP Activities at the OECD
  Joop de Knecht, Organisation for Economic Co-operation and Development (OECD)
• AOP Knowledge Base/Wiki Tool Set
  Steven Edwards, U.S. Environmental Protection Agency (EPA)
• Outcomes from the March Somma Lombardo Workshop
  Edward Perkins, U.S. Army

Session 2: AOPs Under Development

• Embryonic Vascular Disruption and Adverse Prenatal Outcomes
  Nicole Kleinstreuer, ILS/NICEATM
• Using Adverse Outcome Pathway Analysis to Identify Gaps in High-Throughput Screening for Thyroid Disruption 
  Katie Paul, Bayer CropScience
• Application of the Adverse Outcome Pathway (AOP) Concept to Neurotoxicology: A Challenging Approach
  Ellen Fritsche, IUF Dusseldorf
• AOP Development: After the Heights of the Mountains – the Hardship of the Plains; the Example of Liver Fibrosis
  Brigitte Landesmann, European Commission Joint Research Center (JRC)
• Fish Early Life Stage: Developing AOPs to Support Targeted Reduction and Replacement
  Dan Villeneuve, EPA
• Adverse Outcome Pathway for Effects of Anticoagulant Rodenticides on Predatory Birds
  Barnett Rattner, U.S. Geological Survey, U.S. Department of the Interior
• Adverse Outcome Pathway (AOP) for Sustained Aryl Hydrocarbon Receptor Activation Leading to Rodent Liver Tumor Promotion
  Ted Simon, Ted Simon LLC
• Developing AOPs from PPAR Activation Leading to Reproductive Toxicity
  Malgorzata Nepelska, European Union Joint Research Centre
• Framework for Computationally-Predicted AOPs
  Shannon Bell, EPA

Session 3: Case Studies: Regulatory Uses for Well-Identified AOPs

• Testing of the Predictive Power and Robustness of an AOP Construct for Bile Salt Export Pump Inhibition to Cholestatic Injury
  Mathieu Vinken, Vrije Universiteit Brussel
• An Adverse Outcome Pathway (AOP) Framework for Screening for Potential Endocrine Disruption
  David Dix, EPA
• AOPs and Regulatory Decisions: Problem Formulation, Development and Acceptance
  Rita Schoeny, EPA
• Identifying Integrated In Vitro/In Silico Testing Strategies (IATA/ITS) by Mapping to the Skin Sensitization AOP
  Joanna Matheson, U.S. Consumer Product Safety Commission

Session 4: The Risk Context

• Exposure and Dosimetry Considerations for AOPs
  John Wambaugh, EPA
• Ozone-Induced Lung Inflammation and Injury: From Mechanism to Adversity in Humans
  Robert Devlin, EPA
• Suspected Modes of Action Affected by Pesticides Exposure: Informing an Adverse Outcomes Pathway (AOP) for Cancer
  Michael Alavanja, U.S. National Cancer Institute

Breakout Groups

Group 1: The Process of Regulatory Acceptance

• Breakout Group Summary Presentation
  David Dix, EPA, and Craig Rowlands, The Dow Chemical Company
• AOP Development Processes in OECD and Regulatory Agency Acceptance
  Working Group of National Coordinators, OECD Test Guidelines Programme
  Christine Olinger and Melissa Panger, EPA
• How Do We Establish Scientific Confidence in AOPs?
  Rick Becker, American Chemistry Council
• Regulatory Acceptance: How to Strengthen Protection of Susceptible Populations in AOP Approaches
  Ruthann Rudel, Silent Spring Institute

Group 2: Using AOPs for Regulatory Decisions: Confidence and Criteria

• Breakout Group Summary Presentation
  Suzanne Fitzpatrick, FDA, and Annie Jarabek, EPA
• Contaminants in the Food Supply: How the AOP Concept Can Help Regulators Make Decisions Using Arsenic as a Case Study
  Christina Powers, EPA
• Decision Analytic Approach to Advance Application of AOPs in Risk Assessment: Characterization Criteria to Establish Confidence 
  Annie Jarabek, EPA
• Using Evidence-Based Toxicology to Evaluate AOPs 
  Thomas Hartung, Center for Alternatives to Animal Testing, Johns Hopkins University

Group 3: Taking Qualitative AOPs to the Next (Quantitative) Level

• Breakout Group Summary Presentation
  Nicole Kleinstreuer, ILS/NICEATM, and Kristie Sullivan, Physicians Committee for Responsible Medicine
• A Quantitative AOP for Skin Sensitization
  Gavin Maxwell, Unilever
• A Conceptual Model that Enables Quantitative Integration of Data Into an AOP
  Catherine Willett, Humane Society of the United States
• Applying Semantic and Network Methods in AOP Knowledge
  David Wild, University of Indiana School of Informatics and Computing

Presentations by Junior Investigators with Outstanding Poster Abstracts

• Quantitative Weight of Evidence Model for Assessing Adverse Outcome Pathways 
  Dasha Agoulnik, University of Massachusetts Lowell/U.S. Army Engineer Research and Development Center
• Developmental Neurotoxicity of Epigallocatechin Gallate by Interference With beta-1-Integrin Function: A Novel AOP Framework Supporting Neurodevelopmental Toxicity Research and Risk Assessment
  Marta Barenys, Liebniz Research Institute of Environmental Medicine
• Cross-Species Extrapolation of an Adverse Outcome Pathway for Ecdysteroid Receptor Activation 
  Carlie LaLone, EPA
• Short-Term Atrazine Exposure Alters the Plasma Metabolome of Male C57BL/6 Mice and Disrupts Specific Metabolic Pathways
  Zhoumeng Lin, University of Georgia

Hands-On Demonstration/Training

• Entering an AOP into the OECD Wiki
  Stephen Edwards, EPA
• Introduction to Effectopedia
  Hristo Aladjov, OECD

Scientific Workshop - Adverse Outcome Pathways: From Research to Regulation Videos

September 3, 2014

Videocasts of Workshop Plenary Sessions on NIH Website

• Day 1 (Wednesday, Sept. 3)
• Day 2 (Thursday, Sept 4)
• Day 3 (Friday, Sept 5)

Workshop on Alternatives to the HIST for Acellular Pertussis Vaccines: Progress and Challenges in the Replacement of HIST Final Documents

August 24, 2014

• Workshop Report (Pharmeuropa Bio Scientific Notes)

Workshop on Alternatives to the HIST for Acellular Pertussis Vaccines: Progress and Challenges in the Replacement of HIST Meeting Materials

August 24, 2014

• Workshop Flyer
• Report from March 2015 Follow-up Workshop (Pharmeuropa Bio Scientific Notes)

Peer Review of Draft Report on Carcinogens (RoC) Monograph on Trichloroethylene (TCE) Final Documents

August 12, 2014

Webinar on Lessons Learned in Application of the OHAT Framework for Systematic Review and Evidence Integration to Case Studies Meeting Materials

July 31, 2014

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ICCVAM Public Forum Final Documents

June 25, 2014

• Read article about meeting (NIEHS Environmental Factor newsletter, August 2014)

ICCVAM Public Forum Meeting Materials

June 25, 2014

• Summary (NIEHS Environmental Factor newsletter)

ICCVAM Public Forum Presentations

June 25, 2014

ICCVAM and NICEATM Updates

• ICCVAM Committee Activities
  Anna Lowit, Office of Pesticide Products, U.S. Environmental Protection Agency; ICCVAM Co-chair
• Skin Sensitization Working Group Activities
  Joanna Matheson, U.S. Consumer Product Safety Commission
• NICEATM Update
  Warren Casey, National Institute of Environmental Health Sciences

ICCVAM Agency Updates

• Food and Drug Administration
  Abby Jacops, Center for Drug Evaluation and Research, U.S. Food and Drug Administration; ICCVAM Co-chair
• Environmental Protection Agency
  Anna Lowit, OPP/EPA
• National Institute of Environmental Health Sciences
  Raymond Tice, NIEHS
• Department of the Interior
  Barnett Rattner, Department of the Interior
• National Institutes of Health
  Christine Kelley, National Institute of Biomedical Imaging and Bioengineering

NTP Board of Scientific Counselors Meeting Meeting Materials

June 17, 2014

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NTP Technical Reports Peer Review Panel Final Documents

May 22, 2014

Final Reports: Bromodichloroacetic Acid, CIMSTAR 3800, Green Tea Extract, Indole-3-carbinol

NTP Technical Reports Peer Review Panel Meeting Materials

May 22, 2014

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Collaborative Workshop on Aquatic Toxicity Models and 21st Century Toxicology Final Documents

May 5, 2014

• Workshop Report (ALTEX)

Collaborative Workshop on Aquatic Toxicity Models and 21st Century Toxicology Meeting Materials

May 5, 2014

• Speaker Biosketches
• Poster Presentation Abstracts

Collaborative Workshop on Aquatic Toxicity Models and 21st Century Toxicology Presentations

May 5, 2014

• Opening Session Abstracts
• Session 1: Cardiovascular Toxicity (abstracts)
• Session 2: Developmental Processes in Toxicity and Disease (abstracts)
• Session 3: Emerging Technologies (abstracts)
• Session 4: Models of Neurobehavior and Neurotoxicity (abstracts)
• Session 5: Predicting Alterations to the Immune System (abstracts)
• Session 6: Emerging Issues (abstracts)

NTP Board of Scientific Counselors Meeting Meeting Materials

April 16, 2014

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NTP Report on Carcinogens Webinar on Trichloroethylene Meeting Materials

March 17, 2014

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Peer Review of Draft RoC Monographs for ortho-Toluidine and Pentachlorophenol Final Documents

December 12, 2013

Peer Review of Draft RoC Monographs for ortho-Toluidine and Pentachlorophenol Meeting Materials

December 12, 2013

Draft Monographs

• ortho-Toluidine
• Pentachlorophenol (Updated 8/30/2013 with revised cover)

Public Comments

Date Received	Name/Affiliation	Agenda Topic
September 23, 2013	Steven H. Wodka, Attorney at Law	Ortho-toluidine
September 24, 2013	Dr. Herbert Estreicher, Attorney at Law	Pentachlorophenol
September 24, 2013	Pentachlorophenol Task Force	Pentachlorophenol
December 13, 2013	Dr. Robert Golden	Pentachlorophenol

Peer Review of Draft RoC Monographs for ortho-Toluidine and Pentachlorophenol Presentations

December 12, 2013

• Format of the Peer Review 
• Preparation of the Draft RoC Monographs: ortho-Toluidine and Pentachlorophenol and By-products of its Synthesis 
• Scientific Issues in Written Public Comments in the Draft RoC Monographs
• Draft Report on Carcinogens Monograph on ortho-Toluidine 
• Draft Report on Carcinogens Monograph on Pentachlorophenol and By-products of its Synthesis
• Draft Report on Carcinogens Monograph on Pentachlorophenol and By-products of its Synthesis – Human Cancer Studies 
• Draft Report on Carcinogens Monograph on Pentachlorophenol and By-products of its Synthesis – Concentration of PCP By-products 
• Draft Report on Carcinogens Monograph on Pentachlorophenol and By-products of its Synthesis – Key Issues for Discussion 

NTP Technical Reports Peer Review Panel Final Documents

October 29, 2013

Final Reports: Cobalt Metal, Tetrabromobisphenol A, Glycidamide, Vinylidene Chloride

NTP Technical Reports Peer Review Panel Meeting Materials

October 29, 2013

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Webinar on OHAT Approach for Systemic Review Meeting Materials

September 26, 2013

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Scientific Advisory Committee on Alternative Toxicological Methods Meetings Meeting Materials

September 24, 2013

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NTP Board of Scientific Counselors Meeting Meeting Materials

June 25, 2013

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Informational Meeting on the Draft OHAT Approach for Systematic Review and Evidence Integration for Literature-based Health Assessments – February 2013 Meeting Materials

April 23, 2013

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NTP Report on Carcinogens Webinar on Pentachlorophenol: Human Cancer Studies on Exposure to Pentachlorophenol (PCP): Differentiating Potential Cancer Effects of PCP Exposure from Effects Due to Occupational Co-exposures or PCP Contaminants Meeting Materials

April 11, 2013

• Abstracts
• Additional information on Pentachlorophenol

NTP Report on Carcinogens Webinar on Pentachlorophenol: Human Cancer Studies on Exposure to Pentachlorophenol (PCP): Differentiating Potential Cancer Effects of PCP Exposure from Effects Due to Occupational Co-exposures or PCP Contaminants Presentations

April 11, 2013

• NTP Report on Carcinogens Public Webinar on Pentachlorophenol: Introduction (Lunn)
• Overview of Occupational Exposures to Pentachlorophenol: Components, Contaminants, and Common Co-Exposures (Dunn)
• Occupational Exposure to Pentachlorophenol and Other Agents (Ruder)
• Occupational Studies of Workers in Pentachlorophenol Production (Collins)
• Epidemiologic Studies of Pentachlorophenol Users (Demers)

Peer Review of Draft RoC Monographs for 1-Bromopropane and Cumene Final Documents

March 21, 2013

• Final monographs: 1-Bromopropane and Cumene

Peer Review of Draft RoC Monographs for 1-Bromopropane and Cumene Meeting Materials

March 21, 2013

Peer Review of Draft Report on Carcinogens Monographs for 1-Bromopropane and Cumene on March 21-22, 2013

Draft Monographs

• 1-Bromopropane
• Cumene

Public Comments

• 1-Bromopropane
  • Dr. Carr J. Smith, Albemarle Corporation
  • Tina D. Craft, Albemarle Corporation
  • Dr. Adam Finkel, University of Pennsylvania
• Cumene
  • Dr. James S. Bus, The Dow Chemical Company
  • Dr. Richard A. Becker and Mr. Jonathan T. Busch, American Chemistry Council (ACC)

Peer Review of Draft RoC Monographs for 1-Bromopropane and Cumene Presentations

March 21, 2013

• Process for Preparing the Draft RoC Monographs for 1-Bromopropane and Cumene
• Written Public Comments Summaries for the Draft RoC Monographs
• Draft Report on Carcinogens Monograph for Cumene
• Draft Report on Carcinogens Monograph for Cumene - Data for Evaluating Alpha-2u Criteria
• Draft Report on Carcinogens Monograph for 1-Bromopropane

Webinar on the Assessment of Data Quality in Animal Studies Meeting Materials

March 20, 2013

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NTP Board of Scientific Counselors Meeting Meeting Materials

December 11, 2012

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International Workshop on Alternatives to the Murine Histamine Sensitization Test (HIST) for Acellular Pertussis Vaccines: State of the Science and the Path Forward Final Documents

November 28, 2012

• Workshop Report (Biologicals)
• Workshop Summary

International Workshop on Alternatives to the Murine Histamine Sensitization Test (HIST) for Acellular Pertussis Vaccines: State of the Science and the Path Forward Presentations

November 28, 2012

Opening Session

• Welcoming Remarks and Introduction to ICCVAM and ICATM Organizations
  William Stokes, DVM, RADM, USPHS, NIEHS/NICEATM
  Karen Midthun, MD; Director, Center for Biologics Evaluation and Research (CBER), U.S. FDA
• Workshop Introduction and Objectives
  Juan Arciniega, DSc, CBER, U.S. FDA
• Plenary Presentation: The Many Faces of Pertussis Toxin
  Nicholas Carbonetti, PhD, University of Maryland Medical School, USA
• Current Regulatory Requirements for Residual Pertussis Toxin Testing of Acellular Vaccines
  Sue Nelson, PhD, Sanofi Pasteur, Canada
• International Collaborative Study on Validation of an In Vitro Assay System as an Alternative to the Current Histamine Sensitization Test for Acellular Pertussis Vaccines
  Dorothy Xing, PhD, National Institute for Biological Standards and Control (NIBSC), United Kingdom
• Overview of the International Working Group for Alternatives to HIST (Phase 1)
  Richard Isbrucker, PhD, Health Canada

Session 1: Alternatives to HIST: Methods and Evaluations: Reports on Alternative Methods to HIST and Results Using Pertussis Toxin-Spiked Vaccine Samples

Biochemical Assays: Carbohydrate-Binding Assay; Enzymatic/HPLC Assays

• Analyses of Pertussis Toxin ADP-ribosyltransferase and Carbohydrate-Binding Activities as an In Vitro Alternative to the In Vivo HIST
  CT Yuen, PhD, NIBSC, United Kingdom
• In Vitro Assays for the Detection of Pertussis Toxin: BSP114 Collaborative Study Results
  Amélie Castiaux, Ir, GlaxoSmithKline, Belgium
• Alternative In Vitro Methods for Detection of Pertussis Toxin in Component Pertussis Vaccines: Results of a BSP114 Phase 1 International Collaborative Study
  Juthika Menon, PhD, Sanofi Pasteur, Canad
• Characteristics of Enzymatic and Binding Activities of Pertussis Toxin According to Chemical Detoxifying Agents
  Hokyung Oh, PhD, Korea Food and Drug Administration, Republic of Korea

Biochemical and Cell-Based Assays: Carbohydrate-Binding Assay, Enzymatic/HPLC Assays, CHO Cell Clustering Assay

• Detection of PTx in Acellular Pertussis Vaccines Using a CHO Cell Clustering Assay, a Carbohydrate-Binding Assay, and an Enzymatic/HPLC Assay
  Richard Isbrucker, PhD, Health Canada
• Cell-Based Assays for Detection of Pertussis Toxin in Acellular Vaccines: The cAMP-PTx Assay and the Pertussis ATP Test (PAT)
  Christina Bache, PhD, Paul-Ehrlich-Institut, Germany
  Marieke Hoonakker, MSc, Netherlands Vaccine Institute, The Netherlands

Genetic Assays: Differential Gene Expression in Monocyte-Derived Dendritic Cells

• Using Pertussis Toxin-Sensitive Genes in Dendritic Cells to Evaluate the Safety of Acellular Pertussis Vaccines
  Stefan F.C. Vaessen, PhD, University of Applied Sciences Utrecht, The Netherlands
• Summary Analysis of Reported Data Sets
  Lev Sirota, PhD, CBER, U.S. FDA

Session 2: The Path Forward: Gaps to Cross and Bridges to Build in the Road Toward the Adoption of Alternatives to HIST

• Opening Remarks
  Richard Isbrucker, PhD, Health Canad
• Plenary Presentation: Pertussis Toxin and the CHO Cell Response
  Erik L. Hewlett, MD, University of Virginia School of Medicine, USA

Draft NTP Monograph on Developmental Effects and Pregnancy Outcomes Associated with Cancer Chemotherapy Use during Pregnancy Final Documents

October 1, 2012

Final Monograph

Draft NTP Monograph on Developmental Effects and Pregnancy Outcomes Associated with Cancer Chemotherapy Use during Pregnancy Meeting Materials

October 1, 2012

Supplemental materials for events, meetings, and workshops prior to 2017 have been archived. These archived materials frequently include presentations, background materials, and public comments. Email us or use our contact form to request a list or copy of archived materials for the following meeting.

 

International Workshop on Alternative Methods for Leptospira Vaccine Potency Testing: State of the Science and the Way Forward Final Documents

September 19, 2012

• Workshop Proceedings (Biologicals)
• Workshop Summary

International Workshop on Alternative Methods for Leptospira Vaccine Potency Testing: State of the Science and the Way Forward Meeting Materials

September 19, 2012

• Breakout Group Questions
• Poster Session Abstracts
  • Alt DP, et al. Evaluation of Ocular Exposure to Leptospira borgpetersenii Serovar Hardjo in the Golden Syrian Hamster
  • Wilson-Welder J, Alt DP. Evaluation of Bovine Neutrophil Activation by Leptospira

International Workshop on Alternative Methods for Leptospira Vaccine Potency Testing: State of the Science and the Way Forward Presentations

September 19, 2012

Opening Session

Welcoming Remarks and Introduction to ICATM Organizations
William Stokes, DVM, RADM, USPHS, NIEHS/NICEATM
Workshop Overview and Objectives
Richard McFarland, PhD, MD, Center for Biologics Evaluation and Research, U.S. FDA
View presentation 

Welcome and Introduction to CVB 
Richard Hill, DVM, MS, Center for Veterinary Biologics, USDA

Session 1: Overview of Public Health Needs, Regulatory Requirements, and Research Initiatives for Leptospira Vaccine Potency Testing

• Leptospirosis: Public Health Perspectives
  Marta A. Guerra, MPH, DVM, PhD, Bacterial Special Pathogens Branch, CDC
• Leptospirosis: Animal Health Perspectives
  Ronald D. Schultz, MS, PhD, University of Wisconsin–Madison, USA
• USDA Regulatory Guidelines and Practices for Veterinary Leptospira Vaccine Potency Testing
  Geetha B. Srinivas, DVM, PhD, Center for Veterinary Biologics, USDA
• European Regulatory Framework and Practices for Veterinary Leptospira Vaccine Potency Testing
  Lukas Bruckner, DVM, Institute of Virology and Immunoprophylaxis, Switzerland
• Next-Generation Human Leptospira Vaccines
  Albert Ko, MD, Yale School of Public Health, USA
• Current NIH Research in Human Leptospira Vaccines
  Joseph J. Breen, PhD, Bacteriology and Mycology Branch, National Institute of Allergy and Infectious Diseases, NIH, USA

Session 2: In Vitro Replacement Alternatives for Potency Testing of Leptospira Vaccines: Development, Validation, and Implementation

• Development of In Vitro Assays for Measuring Relative Potencies of Leptospiral Bacterins Containing Serovars Pomona, Canicola, Grippotyphosa, and Icterohaemorrhagiae
  Kevin W. Ruby, MS, PhD, Center for Veterinary Biologics, USDA
• Validation of Monovalent Leptospira Reference Bacterins for In Vitro Potency Testing: Host Efficacy Trials
  Carole Bolin, DVM, PhD, College of Veterinary Medicine, Michigan State University, USA
• Product-Specific Validation of an In Vitro Assay for Leptospira Potency Testing: An Industry Perspective (1)
  Brett Webster, Boehringer Ingelheim Vetmedica, USA
• Product-Specific Validation of an In Vitro Assay for Leptospira Potency Testing: An Industry Perspective (2)
  Jeffrey Galvin, PhD, Pfizer Animal Health, USA
• Development of Leptospira In Vitro Potency Assays: EU/Industry Experience and Perspectives
  Eric Klaasen, DVM, PhD, MSD Animal Health, The Netherlands
• Expansion of the In Vitro Assay for Leptospira Potency Testing to Other Serovars: Case Study with Leptospira Hardjo
  David P. Alt, DVM, PhD, Infectious Bacterial Diseases Research Unit, ARS, USDA

Session 3: Reduction and Refinement Alternatives for Potency Testing of Leptospira Vaccines: Development, Validation, and Implementation

• Development and Validation of a Serological Potency Test for the Release of Leptospira Vaccines in the European Union
  Elisabeth Balks, DVM, Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Germany
• Product-Specific Validation of a Serological Potency Test for Release of Leptospira Vaccines in the European Union
  Catrina Stirling, PhD, Pfizer Animal Health, United Kingdom
• Opportunities and Strategies to Further Reduce Animal Use for Leptospira Vaccine Potency Testing
  Angela Walker, DVM, PhD, Center for Veterinary Biologics, USDA
• Opportunities and Strategies to Further Refine Animal Use for Leptospira Vaccine Potency Testing
  Elsio A. Wunder, Jr., DVM, PhD, Yale School of Public Health, USA
  Karen K. Brown, PhD, Pair O’Docs Consultants, USA

Scientific Advisory Committee on Alternative Toxicological Methods Meetings Meeting Materials

September 5, 2012

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NTP Board of Scientific Counselors Meeting Meeting Materials

June 21, 2012

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NTP Technical Reports Peer Review Panel Final Documents

February 8, 2012

Final Reports: 3´-Azido-3´-Deoxythymidine (AZT), Mixtures of AZT, Lamivudine (3TC), and Nevirapine (NVP), Pyrogallol, Trimethylolpropane Triacrylate (Technical Grade), Ginkgo biloba extract, N,N-Dimethyl-p-toluidine, β-Picoline

NTP Technical Reports Peer Review Panel Meeting Materials

February 8, 2012

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NTP Board of Scientific Counselors Meeting Meeting Materials

December 15, 2011

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Proposed NTP Review Process for the Report on Carcinogens (RoC) Public Listening Session Meeting Materials

November 29, 2011

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Draft NTP Monograph on Health Effects of Low-level Lead Final Documents

November 17, 2011

Final Monograph

Draft NTP Monograph on Health Effects of Low-level Lead Meeting Materials

November 17, 2011

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International Workshop on Alternative Methods for Human and Veterinary Rabies Vaccine Testing: State of the Science and Planning the Way Forward Final Documents

October 11, 2011

• Workshop Report (Biologicals)
• Workshop Summary

International Workshop on Alternative Methods for Human and Veterinary Rabies Vaccine Testing: State of the Science and Planning the Way Forward Meeting Materials

October 11, 2011

• Poster Session Abstracts
• Workshop Overview

NIEHS Workshop - Advancing Research on Mixtures: New Perspectives and Approaches for Predicting Adverse Human Health Effects Meeting Materials

September 26, 2011

No other materials archived.

Scientific Advisory Committee on Alternative Toxicological Methods Meetings Meeting Materials

June 16, 2011

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NTP Board of Scientific Counselors Meeting Meeting Materials

April 13, 2011

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NTP Technical Reports Peer Review Panel Final Documents

April 5, 2011

Final Reports: AIDS Therapeutics, Acrylamide, Nondecolorized Whole Leaf Extract of Aloe barbadensis Miller, Senna

NTP Technical Reports Peer Review Panel Meeting Materials

April 5, 2011

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NTP Technical Reports Peer Review Panel Final Documents

January 26, 2011

Final Reports: Retinoic Acid/Retinyl Palmitate, alpha,beta-Thujone, Kava Kava Extract, Methyl Trans-styryl Ketone, SAN Trimer

NTP Technical Reports Peer Review Panel Meeting Materials

January 26, 2011

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Best Practices Workshop: Assessing the Potential for Chemically Induced Allergic Contact Dermatitis Final Documents

January 20, 2011

• Article about the workshops (NIEHS Environmental Factor, Feb 2011)

Best Practices Workshop: Assessing the Potential for Chemically Induced Allergic Contact Dermatitis Meeting Materials

January 20, 2011

• Goals, Objectives, and Background Information
• Poster Session Abstracts

Best Practices Workshop: Assessing the Potential for Chemically Induced Allergic Contact Dermatitis Presentations

January 20, 2011

Introduction and Public Health Impact of Chemically Induced Allergic Contact Dermatitis (ACD)
RADM William Stokes, DVM, U.S. Public Health Service, NICEATM, NIEHS

Review of Alternative Test Methods and Integrated Strategies for ACD Hazard Assessments
Joanna Matheson, PhD, Consumer Product Safety Commission

Study Director and IACUC Responsibilities: Consideration of Available Reduction, Refinement, and Replacement Alternative Test Methods
Jodie Kulpa-Eddy, DVM, Animal and Plant Health Inspection Service, Department of Agriculture

Conducting and Interpreting the Murine Local Lymph Node Assay
Michael Woolhiser, PhD, The Dow Chemical Co.

The Reduced Murine Local Lymph Node Assay — Validation Status and Appropriate Use
David Allen, PhD, ILS, Inc., Contractor Supporting NICEATM

The Murine Local Lymph Node Assay: BrdU-ELISA
Judy Strickland, PhD, ILS, Inc., Contractor Supporting NICEATM
View video on cell suspension to accompany slide 5 [WMV]
View video on supernatant removal to accompany slide 6 [WMV]
Captioned and narrated versions of videos available on archived webcast: begin at 120 minutes

The Murine Local Lymph Node Assay: DA
Eleni Salicru, PhD, ILS, Inc., Contractor Supporting NICEATM

Application of Peptide Reactivity for Screening ACD Hazard Potential
Darrell Boverhof, PhD, The Dow Chemical Co.

Roundtable Discussion: Regulatory Agency Requirements and Acceptable Alternative Test Methods for ACD Hazard Assessments

• Consumer Product Safety Commission
  Joanna Matheson, PhD
• Environmental Protection Agency
  Jack Fowle, PhD
• Food and Drug Administration
  Suzanne Fitzpatrick, PhD
• Occupational Safety and Health Administration
  Surender Ahir, PhD

Alternative Test Methods for ACD Hazard Assessment: Case Studies in Breakout Groups
View case study presentations and discussion summaries

New Models in the Validation Pipeline for ACD Hazard Testing

• Joanna Matheson, PhD, Consumer Product Safety Commission
• Hitoshi Sakaguchi, PhD, Kao Corporation

Best Practices Workshop: Assessing the Potential for Chemically Induced Allergic Contact Dermatitis Videos

January 20, 2011

• Webcast Recording (NIH Videocast website, 4 hours, 15 minutes)

Best Practices Workshop: Assessing the Potential for Chemically Induced Eye Injuries Final Documents

January 19, 2011

• Article about the workshops (NIEHS Environmental Factor newsletter, Feb 2011)

Best Practices Workshop: Assessing the Potential for Chemically Induced Eye Injuries Meeting Materials

January 19, 2011

• Goals, Objectives, and Background Information
• Poster Session Abstracts

Best Practices Workshop: Assessing the Potential for Chemically Induced Eye Injuries Presentations

January 19, 2011

Introduction and Public Health Impact of Chemically Induced Eye Injuries
RADM William Stokes, DVM, U.S. Public Health Service, NICEATM, NIEHS

Review of Alternative Test Methods and Integrated Strategies for Ocular Safety Assessments
Jill Merrill, PhD, Center for Drug Evaluation and Research, FDA

Study Director and IACUC Responsibilities: Consideration of Available Reduction, Refinement, and Replacement Alternative Test Methods (USDA)
Jodie Kulpa-Eddy, DVM, Animal and Plant Health Inspection Service, Department of Agriculture

Current Guidelines for Ocular Safety Testing
Deborah McCall, Office of Pesticide Programs, EPA

ICCVAM Evaluation and Recommendations on Best Practices for Incorporating Pain Management and Humane Endpoints in Ocular Safety Testing
RADM William Stokes, DVM, U.S. Public Health Service, NICEATM, NIEHS

The Bovine Corneal Opacity and Permeability (BCOP) Test Method: Validation Status
Elizabeth Lipscomb, PhD, ILS, Contractor Supporting NICEATM

Conducting and Interpreting the BCOP Test Method
Hans Raabe, Institute for In Vitro Sciences, Inc.

The Isolated Chicken Eye Test Method: Validation Status/Conducting and Interpreting the Method
David Allen, PhD, ILS, Contractor Supporting NICEATM
View video on application of liquid test substance to accompany slide 13 [AVI]
View video on application of solid test substance to accompany slide 13 [AVI]
Captioned and narrated versions of videos available on archived webcast: begin at 163 minutes

The Cytosensor Microphysiometer (CM) Test Method: Validation Status
Elizabeth Lipscomb, PhD, ILS, Contractor Supporting NICEATM

Conducting and Interpreting the CM Test Method
Rodger Curren, PhD, Institute for In Vitro Sciences, Inc.

Roundtable Discussion: Regulatory Agency Requirements and Acceptable Alternative Test Methods for Ocular Safety Testing

• Consumer Product Safety Commission
  Joanna Matheson, PhD
• Environmental Protection Agency
  Jack Fowle, PhD
• Food and Drug Administration
  Suzanne Fitzpatrick, PhD
• Occupational Safety and Health Administration
  Surender Ahir, PhD

Alternative Test Methods for Ocular Safety Testing: Case Studies in Breakout Groups
View case study presentations and discussion summaries

New Models in the Validation Pipeline for Ocular Safety Testing

• Jill Merrill, PhD, Center for Drug Evaluation and Research, FDA
• Hitoshi Sakaguchi, PhD, Kao Corporation

Best Practices Workshop: Assessing the Potential for Chemically Induced Eye Injuries Videos

January 19, 2011

• Webcast Recording (NIH Videocast website, 5 hours, 16 minutes)

NTP Workshop: Role of Environmental Chemicals in the Development of Diabetes and Obesity Meeting Materials

January 11, 2011

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NTP Board of Scientific Counselors Meeting Final Documents

November 30, 2010

Biomolecular Screening Branch (BSB) Report (188 kb)  

NTP Board of Scientific Counselors Meeting Meeting Materials

November 30, 2010

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Workshop on Alternative Methods to Reduce, Refine, and Replace the Use of Animals in Vaccine Potency and Safety Testing Final Documents

September 14, 2010

• Workshop report (published in Procedia in Vaccinology)
• Poster presentation abstracts

Workshop on Alternative Methods to Reduce, Refine, and Replace the Use of Animals in Vaccine Potency and Safety Testing Meeting Materials

September 14, 2010

• Agenda
  
  

Workshop on Alternative Methods to Reduce, Refine, and Replace the Use of Animals in Vaccine Potency and Safety Testing Presentations

September 14, 2010

Selected U.S. and International Regulations and Guidances

• Minimum Requirements for Biological Products (2006)
  National Institute of Infectious Diseases, Japan
• ICH Harmonised Tripartite Guideline
  Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products (1999)
  International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
• 21 CFR Part 610: General Biological Products Standards (2008)
  Food and Drug Administration, USA
• General Requirements for the Production and Control of Live and Inactivated Vaccines intended for Fish (1994)
  European Medicines Evaluation Agency
• Guidance for Sponsors: Lot Release Program for Schedule D (Biologic) Drugs (2005)
  Health Canada
• Requirements for Diptheria, Tetanus, Pertussis, and Combined Vaccines (1989)
  Amendments (2003)
  World Health Organization

International Workshop on Alternative Methods to Reduce, Refine, and Replace the Use of Animals in Vaccine Potency and Safety Testing: State of the Science and Future Directions Final Documents

September 14, 2010

• Workshop Report (Procedia in Vaccinology)

International Workshop on Alternative Methods to Reduce, Refine, and Replace the Use of Animals in Vaccine Potency and Safety Testing: State of the Science and Future Directions Meeting Materials

September 14, 2010

• Poster Presentation Abstracts
• Speaker Bios
• References

NTP Board of Scientific Counselors Meeting Meeting Materials

June 21, 2010

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Related Links

• Response to BSC Comments on RoC Draft Substance Profiles (290KB)

Scientific Advisory Committee on Alternative Toxicological Methods Meetings Meeting Materials

June 17, 2010

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NTP Board of Scientific Counselors Meeting Meeting Materials

May 10, 2010

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Related Links

• NTP Brief on Soy Infant Formula: Peer-Review Comments and NTP Response (145KB)

NTP at the 49th SOT Meeting Materials

March 7, 2010

No other materials were archived for this meeting.

NTP Board of Scientific Counselors Meeting Meeting Materials

December 9, 2009

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NTP Board of Scientific Counselors Meeting Technical Reports Review Subcommittee Meeting Materials

November 19, 2009

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Report on Carcinogens (RoC) Expert Panel Meeting: Formaldehyde Final Documents

November 2, 2009

Final Background

Expert Panel Report Part A

• NTP Response to Peer Review Comments

Expert Panel Report Part B

• Recommendation for Listing Status, and the Scientific Justification for the Recommendation 
• NTP Response to the Expert Panel Peer Review Report

Report on Carcinogens (RoC) Expert Panel Meeting: Formaldehyde Meeting Materials

November 2, 2009

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Scientific Advisory Committee on Alternative Toxicological Methods Meetings Meeting Materials

June 25, 2009

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Report on Carcinogens (RoC) Expert Panel Meeting: Glass Wool Fibers Final Documents

June 9, 2009

Final Background

Expert Panel Report Part A

• NTP Response to Peer Review Comments
• NTP Response to Expert Panel Report

Expert Panel Report Part B

• Recommendation for Listing Status, and the Scientific Justification for the Recommendation
• NTP Response to the Expert Panel Peer Review Report

Report on Carcinogens (RoC) Expert Panel Meeting: Glass Wool Fibers Meeting Materials

June 9, 2009

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NTP Board of Scientific Counselors Meeting Technical Reports Review Subcommittee Meeting Materials

February 25, 2009

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