How Protective is the Pesticide Risk Assessment and Registration Process to Humans in the United States?

Authors

  • Raghavendhran Avanasi Syngenta Crop Protection, LLC https://orcid.org/0000-0003-1122-4854
  • Aubrey Glover Syngenta Crop Protection, LLC.
  • Caleb Lord Syngenta Crop Protection, LLC.
  • Jessica Macari Syngenta Crop Protection, LLC.
  • Michael Munday Syngenta Crop Protection, LLC.
  • Carol McKillican Syngenta Crop Protection, LLC.
  • Nestor Algarin Syngenta Crop Protection, LLC.
  • Amy McCaskill Syngenta Crop Protection, LLC.
  • Ronald Hampton Syngenta Crop Protection, LLC.
  • Richard Brain Syngenta Crop Protection, LLC.
  • Kevin Leiner

DOI:

https://doi.org/10.21423/JRS.REGSCI.111249

Keywords:

pesticide risk assessment, pesticide registration, compounding health-protectiveness, human health protection

Abstract

The need to feed the growing world population is a daunting challenge and improving crop yield using technology (e.g., synthetic pesticides) is a primary solution being utilized by growers globally. However, there is a general perception that the U.S. population is not well protected from the effects of using pesticides. This leads us to a natural question: how protective to humans is the pesticide risk assessment and registration process in the U.S.? In this commentary, we aim to give an overview of the regulatory history of pesticides in the U.S. and systematically discuss the data-driven, comprehensive, and health-protective methods employed by the U.S. Environmental Protection Agency (EPA) in accordance with the stringent mandates of the laws passed by U.S. Congress and the regulations enacted by the EPA to protect the U.S. population. By describing the studies required under the Code of Federal Regulations (CFR), along with the health-protective models and assumptions employed by the EPA to evaluate the potential for human health risks from pesticides, we aim to highlight the compounding health-protectiveness of the existing regulatory framework. We emphasize the need to maintain a regulated risk-benefit balance in using modern agricultural technology, similar to what is done with other indispensable modern human innovations and technologies.      

References

Boone, M. D., Bishop, C. A., Boswell, L. A., Brodman, R. D., Burger, J., Davidson, C., Gochfeld, M., Hoverman. et al. (2014) Pesticide regulation amid the influence of industry. Bioscience 64(10):917–922

Bruce, A. B., Borlu, Y., Glenna, L. L. (2022). Assessing the scientific support for U.S. EPA pesticide regulatory policy governing active and inert ingredients. Journal of Environmental Studies and Sciences. J Environ Stud Sci. https://doi.org/10.1007/s13412-022-00788-4

Council for Agricultural Science and Technology (CAST). (2019). Interpreting Pesticide Residues in Food. Issue Paper 66. Retrieved from https://www.cast-science.org/publication/interpreting-pesticide-residues-in-food/

Crépet, A., Luong, T. M., Baines, J., Boon, P. E., Ennis, J., Kennedy, M., Massarelli, I., Miller, D., Nako, S., Reuss, R., Yoon, H. J., & Verger, P. (2021). An international probabilistic risk assessment of acute dietary exposure to pesticide residues in relation to codex maximum residue limits for pesticides in food. Food Control, 121(August 2020). https://doi.org/10.1016/j.foodcont.2020.107563

Food and Agriculture Organization. (2009). Declaration of the World Summit on Food Security. Retrieved from https://www.fao.org/fileadmin/templates/wsfs/Summit/Docs/Final_Declaration/WSFS09_Declaration.pdf

Food Quality Protection Act. (1996). Food Quality Protection Act of1996, Public Law 104-170

Gehen, S., Corvaro, M., Jones, J., Ma, M., & Yang, Q. (2019). Challenges and Opportunities in the Global Regulation of Crop Protection Products [Review-article]. Organic Process Research & Development, 23, 2225–2233. https://doi.org/10.1021/acs.oprd.9b00284

Hays, S. M., Becker, R. A., Leung, H. W., Aylward, L. L., Pyatt, D. W. (2007). Biomonitoring equivalents: a screening approach for interpreting biomonitoring results from a public health risk perspective.Regul Toxicol Pharmacol47:96-10917030369

Lewis, R. W., Billington, R., Debryune, E., Gamer, A., Lang, B., & Carpanini, F. (2002). Recognition of Adverse and Nonadverse Effects in Toxicity Studies. Toxicologic Pathology, 30(1), 66–74. https://doi.org/10.1080/01926230252824725

Maienfisch, P., & Stevenson, T. M. (2015). Modern agribusiness - Markets, companies, benefits and challenges. ACS Symposium Series, 1204, 1–13. https://doi.org/10.1021/bk-2015-1204.ch001

Moore, D. R. J., Mccarroll-butler, C. A., Avanasi, R., & Chen, W., White, M. & Brain R.A. (2021). Regulatory Science How Protective to the Environment is the Pesticide Risk Assessment and Registration Process in the United States ? Journal of Regulatory Science, 9(2), 1–20.

National Research Council. 1983. Risk assessment in the federal government. Managing the process. National Academy Press, Washington, DC.

Organisation for Economic Co-operation and Development. (2016). OECD document on crop field trials. OECD Environment, Health and Safety Publications, Paris, 2016. Retrieved December 1 2021 from https://one.oecd.org/document/ENV/JM/MONO(2011)50/REV1/en/pdf

Popp, J., Hantos, K. (2011). Studies in agricultural economics. No. 113. Stud Agric Econ, 113, 47–66.

Popp, J. (2011). Cost-benefit analysis of crop protection measures. Journal Fur Verbraucherschutz Und Lebensmittelsicherheit, 6(SUPPL. 1), 105–112. https://doi.org/10.1007/s00003-011-0677-4

Sobus, J. R., DeWoskin, R. S., Tan, Y., Pleil, J. D., Philips, M. B., George, B. J., Christensen, K., Schreinemachers, D. M., Williams, M, A., Cohen-Hubal, E. A., Edwards, S. (2015). Uses of NHANES Biomarker Data for Chemical Risk Assessment: Trends, Challenges, and Opportunities. Environ Health Perspect 123: 919-927; doi.org/10.1289/ehp.1409177.

United States Department of Agriculture. (2015). Pesticide Data Program. Retrieved December 1 2021 from https://www.ams.usda.gov/sites/default/files/media/PDP%20factsheet.pdf

United States Environmental Protection Agency. (1988). EPA History: FIFRA Amendments of 1988. U.S. Environmental Protection Agency, Washington, D.C. Retrieved December 1 2021 from https://archive.epa.gov/epa/aboutepa/epa-history-fifra-amendments-1988.html#:~:text=The%20Federal%20Insecticide%2C%20Fungicide%20and%20Rodenticide%20Act%20(FIFRA)%20governs,sold%20or%20distributed%20in%20commerce

United States Environmental Protection Agency. (1994). The role of BEAD in pesticide regulation. U.S. Environmental Protection Agency, Washington, D.C. Retrieved December 1 2021 from https://nepis.epa.gov/Exe/ZyPDF.cgi/200001EH.PDF?Dockey=200001EH.PDF

United States Environmental Protection Agency. (1996a). Summary of the Federal Insecticide, Fungicide, and Rodenticide Act. U.S. Environmental Protection Agency, Washington, D.C. Retrieved December 1 2021 from https://www.epa.gov/laws-regulations/summary-federal-insecticide-fungicide-and-rodenticide-act

United States Environmental Protection Agency. (1996b). Summary of the Food Quality Protection Act. U.S. Environmental Protection Agency, Washington, D.C. Retrieved December 1 2021 from https://www.epa.gov/laws-regulations/summary-food-quality-protection-act

United States Environmental Protection Agency. (2000a). Available information on assessing exposure from pesticides in food- A User's guide. U.S. Environmental Protection Agency, Washington, D.C. Retrieved December 1 2021 from https://www.regulations.gov/document/EPA-HQ-OPP-2007-0780-0001

United States Environmental Protection Agency. (2000b). Choosing a percentile of acute dietary exposure as a threshold of regulatory concern. U.S. Environmental Protection Agency, Washington, D.C. Retrieved December 1 2021 from https://www.epa.gov/sites/default/files/2015-07/documents/trac2b054_0.pdf

United States Environmental Protection Agency. (2001a). General Principles For Performing Aggregate Exposure And Risk Assessments. U.S. Environmental Protection Agency, Washington, D.C. Retrieved December 1 2021 from https://www.epa.gov/sites/default/files/2015-07/documents/aggregate.pdf

United States Environmental Protection Agency. (2001b). Science advisory council for exposure policy 9.1. Standard values for daily acres treated in agriculture. U.S. Environmental Protection Agency, Washington, D.C.

United States Environmental Protection Agency. (2002a). Summary of the Federal Food, Drug, and Cosmetic Act. U.S. Environmental Protection Agency, Washington, D.C. Retrieved December 1, 2021 from https://www.epa.gov/laws-regulations/summary-federal-food-drug-and-cosmetic-act

United States Environmental Protection Agency. (2002b). Determination of the appropriate FQPA safety factor(s) in tolerance assessment. U.S. Environmental Protection Agency, Washington, D.C. Retrieved December 1, 2021 from https://www.epa.gov/sites/default/files/2015-07/documents/determ.pdf

United States Environmental Protection Agency. (2002c). A review of the reference dose and reference concentration processes. U.S. Environmental Protection Agency, Washington, D.C. Retrieved December 1, 2021 from https://www.epa.gov/sites/default/files/2014-12/documents/rfd-final.pdf

United States Environmental Protection Agency. (2002d). Guidance on Cumulative Risk Assessment of Pesticide Chemicals That Have a Common Mechanism of Toxicity. U.S. Environmental Protection Agency, Washington, D.C. Retrieved December 1, 2021 from https://www.epa.gov/sites/default/files/2015-07/documents/guidance_on_common_mechanism.pdf

United States Environmental Protection Agency. (2005). Chemicals Evaluated for Carcinogenic Potential by the Office of Pesticide Programs. U.S. Environmental Protection Agency, Washington, D.C. Retrieved December 1, 2021 from http://npic.orst.edu/chemicals_evaluated.pdf

United States Environmental Protection Agency. Exposure Factors Handbook 2011 Edition (Final Report). U.S. Environmental Protection Agency, Washington, DC, EPA/600/R-09/052F, 2011.

United States Environmental Protection Agency. (2012a). Exposure Models: DEEM-FCID/Calendex/SHEDS. U.S. Environmental Protection Agency, Washington, D.C. Retrieved December 1, 2021 from https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/deem-fcidcalendex-software-installer#models

United States Environmental Protection Agency. (2012b). Standard Operating Procedure for Residential Exposure and Risk Assessment for Pesticides. U.S. Environmental Protection Agency, Washington, D.C. Retrieved December 1, 2021 from https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedure-residential-exposure

United States Environmental Protection Agency. (2012c). Guidance for Requiring/Waiving Turf Transferable Residue and Dislodgeable Foliar Residue Studies. U.S. Environmental Protection Agency, Washington, D.C. 2012.

United States Environmental Protection Agency. (2016). Office of Pesticide Programs’ Framework for Incorporating Human Epidemiologic & Incident Data in Risk Assessments for Pesticides Environmental Protection Agency, Washington, D.C. Retrieved December 1, 2021 from https://www3.epa.gov/pesticides/EPA-HQ-OPP-2008-0316-DRAFT-0075.pdf

United States Environmental Protection Agency. (2018a). PRIA Overview and History. U.S. Environmental Protection Agency, Washington, D.C. Retrieved December 1, 2021 from https://www.epa.gov/pria-fees/pria-overview-and-history#pria4

United States Environmental Protection Agency. (2018b). Assessment of Occupational Exposure for Post-Harvest Commodity Pesticide Treatments. U.S. Environmental Protection Agency, Washington, D.C. 2012

United States Environmental Protection Agency. (2019). Directive to Prioritize Effects to Reduce Animal Testing. U.S. Environmental Protection Agency, Washington, D.C. Retrieved December 1, 2021 from https://www.epa.gov/sites/production/files/2019-09/documents/image2019-09-09-231249.pdf

United States Environmental Protection Agency. (2020a). PART 180—Tolerances and exemptions for pesticide chemical residues in food. U.S. Environmental Protection Agency, Washington, D.C. Retrieved December 1, 2021 from https://www.govinfo.gov/content/pkg/CFR-2020-title40-vol26/pdf/CFR-2020-title40-vol26-part180.pdf

United States Environmental Protection Agency. (2020b). PART 160—Good Laboratory Practice Standards. U.S. Environmental Protection Agency, Washington, D.C. Retrieved December 1, 2021 from https://www.govinfo.gov/content/pkg/CFR-2020-title40-vol26/pdf/CFR-2020-title40-vol26-part160.pdf

United States Environmental Protection Agency. (2020c). PART 158—Data requirements for pesticides. U.S. Environmental Protection Agency, Washington, D.C. Retrieved December 1, 2021 from https://www.govinfo.gov/content/pkg/CFR-2020-title40-vol26/pdf/CFR-2020-title40-vol26-part158.pdf

United States Environmental Protection Agency. (2020d). PART 170—Worker protection Standard. U.S. Environmental Protection Agency, Washington, D.C. Retrieved December 1, 2021 from https://www.govinfo.gov/content/pkg/CFR-2020-title40-vol26/pdf/CFR-2020-title40-vol26-part170.pdf

United States Environmental Protection Agency. (2021a). Pesticide Registration Manual. U.S. Environmental Protection Agency, Washington, D.C. Retrieved December 1, 2021 from https://www.epa.gov/pesticide-registration/pesticide-registration-manual

United States Environmental Protection Agency. (2021b). About Pesticide Registration. U.S. Environmental Protection Agency, Washington, D.C. Retrieved December 1, 2021 from https://www.epa.gov/pesticide-registration/about-pesticide-registration

United States Environmental Protection Agency. (2021c). The U.S. EPA's What We Eat in America - Food Commodity Intake Database, 2005-2010 (WWEIA-FCID 2005-10). Environmental Protection Agency, Washington, D.C. Retrieved December 1, 2021 from https://fcid.foodrisk.org/#

United States Environmental Protection Agency. (2021d). Occupational Pesticide Handler Unit Exposure Surrogate Reference Table. Environmental Protection Agency, Washington, D.C. Retrieved December 1, 2021 from https://www.epa.gov/sites/default/files/2021-05/documents/occupational-pesticide-handler-unit-exposure-surrogate-reference-table-may-2021.pdf

United States Environmental Protection Agency. (2021e). Science Advisory Council for Exposure(ExpoSAC) Policy 3. Environmental Protection Agency, Washington, D.C. Retrieved December 1, 2021 from https://www.epa.gov/sites/default/files/2021-03/documents/usepa-opp-hed_exposac_policy_3_march2021_0.pdf

United States Environmental Protection Agency. (2021f). OPP Report on Incident Information: The Baseline. Environmental Protection Agency, Washington, D.C. Retrieved December 1, 2021 from https://archive.epa.gov/pesticides/ppdc/web/pdf/session10-finalrpt.pdf

United States Environmental Protection Agency. (2021g). Restricted Use Products (RUP) Report. Environmental Protection Agency, Washington, D.C. Retrieved December 1, 2021 from https://www.epa.gov/pesticide-worker-safety/restricted-use-products-rup-report

United States Environmental Protection Agency. (2021h). Conventional Reduced Risk Pesticide Program. Environmental Protection Agency, Washington, D.C. Retrieved December 1, 2021 from https://www.epa.gov/pesticide-registration/conventional-reduced-risk-pesticide-program

United States Environmental Protection Agency. (2022a). Standard Operating Procedures (SOPs) for Seed Treatment. Environmental Protection Agency, Washington, D.C. Retrieved December 1, 2021 from https://www.epa.gov/system/files/documents/2022-01/exposac-policy-14_seed-treatment-exposure-data.pdf

United States Environmental Protection Agency. (2022b). Standard Values for Amount of Seed Treated and/or Planted Per Day. Environmental Protection Agency, Washington, D.C. Retrieved December 1, 2021 from https://www.epa.gov/system/files/documents/2022-01/exposac-policy-15_amount-seed-treated-planted.pdf

United States Environmental Protection Agency. (2022c). PRN 97-6: Use of Term "Inert" in the Label Ingredients Statement. Environmental Protection Agency, Washington, D.C. Retrieved November 1, 2022 from https://www.epa.gov/pesticide-registration/prn-97-6-use-term-inert-label-ingredients-statement

United States Environmental Protection Agency. (2022d). PRN 97-6: Developing Relative Potency Factors For Pesticide Mixtures: Biostatistical Analyses Of Joint Dose-Response. Environmental Protection Agency, Washington, D.C. Retrieved November 1, 2022 https://cfpub.epa.gov/ncea/risk/recordisplay.cfm?deid=66273

Winter, C. K., & Katz, J. M. (2011). Dietary exposure to pesticide residues from commodities alleged to contain the highest contamination levels. Journal of Toxicology, 2011(6). https://doi.org/10.1155/2011/589674

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2023-02-01 — Updated on 2023-02-04

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