LOAEL

Lowest Observed Adverse Effect Level

LOEL

Lowest Observed Effect Level

MTD

Maximally Tolerated Doses

NAS

National Academy of Sciences

NBAC

National Bioethics Advisory Commission

NCQA

National Committee on Quality Assurance

NIH

National Institutes of Health

NOAEL

No Observed Adverse Effect Level

NOEL

No Observed Effect Level

NRC

National Research Council

OHRP

Office for Human Research Protections

OIG

Office of Inspector General

OP

Organophosphates

OPRR

Office for Protection from Research Risks

PBPK

Physiologically-Based Pharmacokinetic

PD

Pharmacodynamic

PHS

U.S. Public Health Service

PK

Pharmacokinetic

RAC

Recombinant DNA Advisory Committee

RfC

Reference Concentrations

RfD

Reference Dose

SAB

Science Advisory Board

SAP

Science Advisory Panel

TSCA

Toxic Substance Control Act

UF

Uncertainty Factor

VOC

Volatile Organic Chemicals

Front Matter (R1-R18)

Executive Summary and Recommendations (1-20)

1 Introduction and Background (21-45)

2 The Regulatory Framework for Protecting Humans in Research (46-65)

3 Scientific Justification for and Conduct of Intentional Human Dosing Studies (66-83)

4 A Risk-Benefit Framework for Assessing Intentional Human Dosing Studies (84-109)

5 Ethical Considerations in the Review of Intentional Human Dosing Studies (110-131)

6 Procedures for EPA Review of Intentional Human Dosing Studies (132-143)

7 EPA's Use of Data from Intentional Human Dosing Studies in Risk Assessment (144-158)

Appendix A: Values and Limitations of Animal Toxicity Data (159-167)

Appendix B: Pharmacokinetics and Metabolism of Pesticides (168-172)

Appendix C: Biographical Sketches of the Members and Staff of the Committee on the Use of Third Party Toxicity Research with Human Research Participants (173-184)

Appendix D: Biographical Sketches of the Members of the Science, Technology, and Law Panel (185-191)

Appendix E: Meeting Agendas (192-200)

Appendix F: Combined Registrants List for All Meetings (201-208)