Human testing of pesticides: Ethical and scientific considerations

American Journal of Public Health

Volumn 94, Issue 11, 2004, Pages 1908-1916

  Lockwood, Alan H ^a,b  

^a UNIVERSITY AT BUFFALO   (United States)

^b VA WESTERN NEW YORK HEALTHCARE SYSTEM   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALDICARB; AZINPHOS METHYL; CARBAMIC ACID; CHLORPYRIFOS; DICHLORVOS; PESTICIDE;

CONCENTRATION RESPONSE; ENVIRONMENTAL PROTECTION; ETHICS; EVALUATION; FINANCIAL MANAGEMENT; HUMAN; METHODOLOGY; REGISTRATION; REVIEW; RISK ASSESSMENT; SCIENCE; STATISTICAL ANALYSIS;

EID: 7444265387     PISSN: 00900036     EISSN: None     Source Type: Journal    
DOI: 10.2105/AJPH.94.11.1908     Document Type: Review

References (34)

1. US Environmental Protection Agency. Terms of environment Web site. Available at: http://www.epa.gov/OCEPAterms. Accessed October 6, 2004.
2. Committee on Pesticide Residues in the Diets of Infants and Children. Pesticides in the Diets of Infants and Children. Washington, DC: National Academy Press; 1993.
3. Committee on the Use of Third Party Toxicity Research with Human Research Participants, National Research Council, National Academy of Sciences. Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues. Washington, DC: National Academy Press: 2004.
4. Scientific Advisory Board and FIFRA Scientific Advisory Panel. Comments on the use of data from the testing of human subjects. EPA-SAB-EC-00-017. Washington, DC: US Environmental Protection Agency; 2000.
5. Oleskey C, Fleischman A, Goldman LR, et al. Pesticide testing in humans: ethics and public policy. Environ Health Perspect. 2004;112:914-919.
6. Gledhill AJ. Dichlorvos: a study to investigate erythrocyte cholinesterase inhibition following oral administration to healthy male volunteers. Alderley Park MacClesfield, Cheshire, UK: Central Toxicology Laboratory; February 3, 1997. EPA MIRD number 443179-01.
7. Gledhill AJ. Dichlorvos: a single blind, placebo controlled, randomized study to investigate the effects of multiple oral dosing on erythrocyte cholinesterase inhibition in healthy male volunteers. Alderley Park MacClesfield, Cheshire, UK: Central Toxicology Laboratory; March 24, 1997. EPA MIRD number 442488-01.
8. Gledhill AJ. Dichlorvos: a study to investigate the effect of a single oral dose on erythrocyte cholinesterase inhibition in healthy male volunteers. Alderley Park MacClesfield, Cheshire, UK: Central Toxicology Laboratory; March 25, 1997. EPA MIRD number 442488-02.
9. Kisicki JC, Seip CW, Combs ML. A rising dose toxicology study to determine the no-observable-effect levels (NOEL) for erythrocyte acetylcholinesterase (AChE) inhibition and cholinergic signs and symptoms of chlorpyrifos at three dose levels. Lincoln, Neb: MDS Harris; April 19, 1999. Project 21438.
10. McFarlane P, Freestone S. A randomized double blind placebo controlled study with azinphos-methyl to determine the no effect level on plasma and RBC cholinesterase activity after repeat doses. Edinburgh, Scotland: Inveresk Clinical Research Ltd.; April 15, 1999.
11. Wyld PJ, Watson CE, Nimmo WS, Watson M. A safety and tolerability study of aldicarb at various dose levels in healthy male and female volunteers. EPA MIRD Number 423730-01. Edinburgh, Scotland: Inveresk Clinical Research Ltd.; March 11, 1992.
12. World Medical Association. Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects (amended up to and including 52nd WMA General Assembly, Edinburgh, Scotland, October 2000 with note of clarification on paragraph 29 added, Washington, DC 2002: World Medical Association; 2002.
13. Goldman LR, Smith DF, Neutra RR, et al. Pesticide food poisoning from contaminated watermelons in California, 1985. Arch Environ Health. 1990;45:229-236.
14. Furlong CE, Li WF, Richter RJ, et al. Genetic and temporal determinants of pesticide sensitivity: role of paraoxonase (PON1). Neurotoxicology. 2000;21:91-100.
15. Committee on Assessing the System for Protecting Human Research Participants, Institute of Medicine. Responsible Research, a Systems Approach to Protecting Research Participants. Washington, DC: National Academy Press; 2002.
16. International Committee of Medical Journal Editors. Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication. Available at: http://www.icmje.org. Accessed April 23, 2004.
17. Amler RW, Rice DC, Johnson BL. Assessment of mercury neurotoxicity through psychometric and neurobehavioral testing: session summary. Neurotoxicology. 1996;17:237-239.
18. Weissenborn K, Scholz M, Hinrichs H, Wiltfang J, Schmidt FW, Kunkel H. Neurophysiological assessment of early hepatic encephalopathy. Electroencephalogr Clin Neurophysiol. 1990;75:289-295.
19. Lockwood AH, Weissenborn K, Bokemeyer M, Tietge U, Burchert W. Correlations between cerebral glucose metabolism and neuropsychological test performance in non-alcoholic cirrhotics. Metab Brain Dis. 2002;17:259-270.
20. Lockwood AH. Pesticides and parkinsonism: is there an etiological link? Curr Opin Neurol. 2000;13:687-690.
21. Sherer TB, Betarbet R, Testa CM, et al. Mechanism of toxicity in rotenone models of Parkinson's disease. J Neurosci. 2003;23:10756-10764.
22. Thiruchelvam M, Richfield EK, Baggs RB, Tank AW, Cory-Slechta DA. The nigrostriatal dopaminergic system as a preferential target of repeated exposures to combined paraquat and maneb: implications for Parkinson's disease. J Neurosci. 2000;20:9207-9214.
23. Centers for Disease Control and Prevention, National Center for Environmental Health, Division of Laboratory Science. Second National Report on Human Exposure to Environmental Chemicals. Atlanta, Ga: US Department of Health and Human Services; 2003.
24. Thiruchelvam M, Richfield EK, Goodman BM, Baggs RB, Cory-Slechta DA. Developmental exposure to the pesticides paraquat and maneb and the Parkinson's disease phenotype. Neurotoxicology. 2002;23:621-633.
25. Steenland K, Jenkins B, Ames RG, O'Malley M, Chrislip D, Russo J. Chronic neurological sequelae to organophosphate pesticide poisoning. Am J Public Health. 1994;84:731-736.
26. Schuh RA, Lein PJ, Beckles RA, Jett DA. Noncholinesterase mechanisms of chlorpyrifos neurotoxicity: altered phosphorylation of Ca2+/cAMP response element binding protein in cultured neurons. Toxicol Appl Pharmacol. 2002;182:176-185.
27. Whyatt RM, Rauh V, Barr DB, et al. Prenatal pesticide exposures, birth weight and length among an urban minority cohort. Environ Health Perspect. 2004;112:1125-1132.
28. Berkowitz TS, Wetmur JGB-DE, Obel J, et al. In utero pesticide exposure, maternal paraoxonase activity and head circumference. Environ Health Perspect. 2004;112:388-391.
29. van Gemert M, Dourson M, Moretto A, Watson M. Use of human data for the derivation of a reference dose for chlorpyrifos. Regul Toxicol Pharmacol. 2001;33:110-116.
30. Office of Pesticide Programs USEPA. Revised Organophosphate Cumulative Risk Assessment. Available at http://www.epa.gov/pesticides/cumulative/rra-op/. Accessed June 10, 2002.
31. Caplan AL. Am I My Brother's Keeper? The Ethical Frontiers of Biomedicine. Bloomington, Ind: University of Indiana Press; 1997.
32. Blackburn E. Bioethics and the political distortion of biomedical science. New Engl J Med. 2004;350:1379-1380.
33. Michaels D, Bingham E, Boden L, et al. Advice without dissent. Science. 2002;298:703.
34. Lockwood, AH. Organophosphate pesticides and public policy. Curr Opin Neurol. 2002;15:725-729.