Setting Pesticide Reference Doses: A Retrospective Analysis Examining Key Data and Choices

Human and Ecological Risk Assessment

Volumn 20, Issue 6, 2014, Pages 1550-1564

  Holman, Elizabeth ^a,b   Gray, George ^b  

^a U S ENVIRONMENTAL PROTECTION AGENCY   (United States)

^b GEORGE WASHINGTON UNIVERSITY   (United States)

Author keywords

pesticides; reference dose; risk assessment; science policy

Indexed keywords

EID: 84898603475     PISSN: 10807039     EISSN: 15497860     Source Type: Journal    
DOI: 10.1080/10807039.2013.879017     Document Type: Article

References (41)

1. Becker RA, Borgert CJ, Webb S, et al. 2006. Report of an ISRTP workshop: Progress and barriers to incorporating alternative toxicological methods in the US. Regul Toxicol Pharmacol 46(1):18-22
2. Billington R, Lewis R, Mehta JM, et al. 2010. The mouse carcinogenicity study is no longer a scientifically justifiable core data requirement for the safety assessment of pesticides. Crit Rev Toxicol 40(1):35-49
3. CFR (Code of Federal Regulations). 2013a. Title 40, Part 180-Tolerances and Exemptions for Pesticide Chemical Residues in Food. Available at http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&tpl=/ecfrbrowse/Title40/40cfr180_main_02.tpl (accessed March 1, 2013)
4. CFR. 2013b. Title 40 §158.500-Toxicology data requirements table, see Footnote 7. Available at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=aa4ad67ac3694225a131745daa99f82d&rgn=div6&view=text&node=40:25.0.1.1.9.6&idno=40 (accessed March 1, 2013)
5. Contrera JF and DeGeorge JJ. 1998. In vivo transgenic bioassays and assessment of the carcinogenic potential of pharmaceuticals. Environ Health Perspect 106(Suppl 1):71
6. Crump KS. 1984. A new method for determining allowable daily intakes. Fundam Appl Toxicol 4(5):854-71
7. Dellarco VL, Rowland J, and May B. 2010. A retrospective analysis of toxicity studies in dogs and impact on the chronic reference dose for conventional pesticide chemicals. Crit Rev Toxicol 40(1):16-23
8. Doe JE, Boobis AR, Blacker A, et al. 2006. A tiered approach to systemic toxicity testing for agricultural chemical safety assessment. CRC Crit Rev Toxicol 36(1):37-68
9. Dudley SE and Gray GM. 2012. Improving the use of science to inform environmental regulation. In: Johnston J (ed), Institutions and Incentives in Regulatory Science, 1st edit, pp 165-94. Lexington Books, Lanham, MD, USA
10. Evans JS and Baird SJS. 1998. Accounting for missing data in noncancer risk assessment. Hum Ecol Risk Assess 4(2):291-317
11. Federal Register. 2007. 60940, Vol. 72, No. 207, Rules and Regulations. Available at http://www.gpo.gov/fdsys/pkg/FR-2007-10-26/pdf/E7-20826.pdf (accessed March 1, 2013)
12. Food Quality Protection Act (FQPA) of 1996,. 7 U.S.C §136d.
13. Goldman LR. 2007. Managing pesticide chronic health risks. J Agromedicine 12(1):67-75
14. Goldman LR and Koduru S. 2000. Chemicals in the environment and developmental toxicity to children: A public health and policy perspective. Environ Health Perspect 108(Suppl 3):443
15. Gray GM and Cohen JT. 2012. Policy: Rethink chemical risk assessments. Nature 489(7414):27-8
16. Gray GM, Li P, Shlyakhter I, et al. 1995. An empirical examination of factors influencing prediction of carcinogenic hazard across species. Regul Toxicol Pharmacol 22(3):283-291
17. Hansson SO and Rudén C. 2007. Towards a theory of tiered testing. Regul Toxicol Pharmacol 48(1):35-44
18. Kavlock R and Dix D. 2010. Computational toxicology as implemented by the US EPA: Providing high throughput decision support tools for screening and assessing chemical exposure, hazard, and risk. J Toxicol Environ Health, Part B 13(2-4):197-217
19. Knudsen TB, Martin MT, Kavlock RJ, et al. 2009. Profiling the activity of environmental chemicals in prenatal developmental toxicity studies using the US EPA's ToxRefDB. Reprod Toxicol 28(2):209-19
20. McDougall P and Business V. 2010. The cost of new agrochemical product discovery, development and registration in 1995 and 2000. 2003. Final Report. Verfügbar.Available at http://Www.Croplife.Org/Files/Documentspublished/1/Enus/REP/5344_REP_2010_03_04_Ph-illips_ McDougal_Research_and_Development_study.pdf [Abfrage Am 24.04.2010] (accessed March 1, 2013)
21. NRC (National Research Council). 2007. Toxicity Testing in the 21st Century: A Vision and a Strategy. National Academies Press, Washington, DC, USA
22. NRC. 2009. Science and Decisions. National Research Council (NRC), National Academy of Sciences, Washington, DC, USA
23. Parham F and Portier C. 2006. Benchmark dose approach. In: Edler L and Kitsos C (eds), Recent Advances in Quantitative Methods in Cancer and Human Health Risk Assessment, 1st edit, pp 239-54, John Wiley and Sons, West Sussex, UK
24. Solecki R, Davies L, Dellarco V, et al. 2005. Guidance on setting of acute reference dose (ARfD) for pesticides. Food Chem Toxicol 43(11):1569-93
25. Solecki R, Moeller T, Herrmann M, et al. 2010. A retrospective analysis of acute reference doses for pesticides evaluated in the european union. Crit Rev Toxicol 40(1):24-34
26. USEPA (US Environmental Protection Agency). 1999. EPA's Risk Assessment Process for Tolerance Reassessment, Staff Paper #44. Available at http://www.epa.gov/oppfead1/trac/paper44.pdf (accessed March 1, 2013)
27. USEPA. 2001. General Principles for Performing Aggregate Exposure and Risk Assessments. Available at http://www.epa.gov/pesticides/trac/science/aggregate.pdf (accessed March 1, 2013)
28. USEPA. 2002a. A Review of the Reference Dose and Reference Concentration Processes. EPA/630/P-02/002F. Risk Assessment Forum, Washington, DC, USA
29. USEPA. 2002b. Determination of the Appropriate FQPA Safety Factor(s) in Tolerance Assessment. Office of Pesticide Programs, Washington, DC, USA
30. USEPA. 2011. Vocabulary Catalog List Detail-Integrated Risk Information System (IRIS) Glossary. Available at http://ofmpub.epa.gov/sor_internet/registry/termreg/searchandretrieve/glossariesandkeywordlists/search.do?details=&glossaryName=IRIS%20Glossary (accessed March 1, 2013)
31. USEPA. 2012a. Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Available at http://www.epa.gov/agriculture/lfra.html (accessed March 1, 2013)
32. USEPA. 2012b. Pesticides: Glossary. Available at http://www.epa.gov/pesticides/glossary/index.html (accessed March 1, 2013)
33. USEPA. 2012c. Human Health Benchmarks for Pesticides. Available at http://iaspub.epa.gov/apex/pesticides/f?p = HHBP:home (accessed March 1, 2013)
34. USEPA. 2012d. Benchmark Dose Technical Guidance. EPA/100/R-12/001. Risk Assessment Forum, Washington, DC, USA
35. USEPA. 2012e. Common Mechanism Groups; Cumulative Exposure and Risk Assessment. Available at http://www.epa.gov/oppsrrd1/cumulative/common_mech_groups.htm (accessed March 1, 2013)
36. USEPA. 2012f. Guidance for Waiving or Bridging of Mammalian Acute Toxicity Tests for Pesticides and Pesticide Products. Available at http://www.epa.gov/pesticides/science/acute-data-waiver-guidance.pdf (accessed March 1, 2013)
37. USEPA. 2013a. Harmonized Test Guidelines. Available at http://www.epa.gov/ocspp/pubs/frs/home/guidelin.htm (accessed March 1, 2013)
38. USEPA. 2013b. EPA Announces New Guidance and Policies for an Integrated Approach to Pesticide Testing and Assessment. Available at http://www.epa.gov/oppfead1/cb/csb_page/updates/2013/new-testing-approach.html (accessed March 1, 2013)
39. USEPA. 2013c. A Retrospective Analysis of the Immunotoxicity Study (OCSPP Test Guideline No. 870. 7800). Available at http://www.epa.gov/pesticides/regulating/immunotoxicity-retro-analysis.pdf (accessed March 1, 2013)
40. USEPA. 2013d. Part 158 Toxicology Data Requirements: Guidance for Neurotoxicity Battery, Subchronic Inhalation, Subchronic Dermal and Immunotoxicity Studies. Available at http://www.epa.gov/pesticides/regulating/part158-tox-data-requirement.pdf (accessed March 1, 2013)
41. Yokota F, Gray G, Hammitt JK, et al. 2004. Tiered chemical testing: A value of information approach. Risk Analysis 24(6):1625-39