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

Authors

  • Dwayne Moore Intrinsik Ltd. https://orcid.org/0000-0002-1763-0223
  • Caleb McCarroll-Butler Intrinsik Corp.
  • Raghavendhran Avanasi Syngenta Crop Protection
  • Wenlin Chen Syngenta Crop Protection
  • Mark White Syngenta Crop Protection
  • Richard Brain Syngenta Crop Protection

DOI:

https://doi.org/10.21423/JRS-V09I2MOORE

Keywords:

pesticide risk assessment, pesticide registration, conservatism, environmental protection, regulatory science

Abstract

The media, public, and other stakeholders are generally unaware of the degree of protection provided to the environment by the current pesticide registration process in the United States. Each pesticide product must meet extensive fate and toxicological data requirements (typically 100+ studies) to be considered by the U.S. Environmental Protection Agency (EPA). The EPA uses that information to conduct ecological, human health, and benefits assessments and make decisions on whether to register pesticides and, if so, under what conditions. The assessments rely on conservative assumptions, models, and inputs to consistently err on the side of caution throughout the pesticide registration process. The rigorous compliance requirements specified in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Endangered Species Act (ESA) are designed to preclude unacceptable adverse effects. However, this reality seldom, if ever, makes headlines. Pesticides are not causing the dire widespread apocalyptic effects often portrayed by some media outlets. Rather, pesticides have been doing what they were intentionally designed to do, controlling pests and increasing yields, within the stringent limitations of registered labels. The continually evolving pesticide registration process was originally predicated on the unintended adverse effects neither anticipated nor considered over 50 years ago, due to insufficient regulation and oversight at the time. However, the contemporary regulatory paradigm in the U.S. is data rich and analysis intensive by design, and perhaps understandably, biased towards ensuring environmental protection when registering pesticides.

https://doi.org/10.21423/jrs-v09i2moore

References

Allen, T. F. H., & Starr, T. B. (1982). Hierarchy: Perspectives for Ecological Complexity. The University of Chicago Press.

AllGov. (2020). National Marine Fisheries Service. Retrieved June 25, 2020 from http://www.allgov.com/departments/department-of-commerce/national-marine-fisheries-service?agencyid=7135

Avery, M. L., Decker, D. G., & Fischer, D. L. (1994). Cage and flight pen evaluation of avian repellency and hazard associated with imidacloprid-treated rice seed. Crop Protection, 13(7), 535-540. https://doi.org/10.1016/0261-2194(94)90107-4

Avery, M. L., Fischer, D. L., & Primus, T. M. (1997). Assessing the hazard to granivorous birds feeding on chemically treated seeds. Pesticide Science, 49(4), 362-366. https://doi.org/10.1002/(SICI)1096-9063(199704)49:4%3C362::AID-PS540%3E3.0.CO;2-W

Birchfield, N., Washington Toxics Coalition, Northwest Coalition for Alternatives to Pesticides, Pacific Coast Federation of Fisherman’s Associations, & Institute for Fisheries Resources (Plaintiffs) vs. Environmental Protection

Agency & Christine T. Whitman (Defendants) vs. American Crop Protection Association et al. (Intervenor-Defendants). (2003). Case No. C01-0123C in the United States District Court for the Western District of Washington.

Boersma, K. S., Bogan, M. T., Henrichs, B. A., & Lytle, D. A. (2014). Invertebrate assemblages of pools in arid-land streams have high functional redundancy and are resistant to severe drying. Freshwater Biology, 59(3), 491-501. https://doi.org/10.1111/fwb.12280

Brain, R. A., & Anderson, J. C. (2019). The agro-enabled urban revolution, pesticides, politics, and popular culture: A case study of land use, birds, and insecticides in the USA. Environmental Science and Pollution Research, 26(21), 21717-21735. https://doi.org/10.1007/s11356-019-05305-9

Brain, R. A., & Hanson, M. L. (2021). The press sells newspapers, we should not sell ecotoxicology. Environmental Toxicology and Chemistry, 40(5), 1239-1240. https://doi.org/10.1002/etc.5003

Brain, R. A., Goodwin, G., Abi-Akar, F., Lee, B., Rodgers, C., Flatt, B., Lynn, A., Kruger, G., & Perkins, D. (2019). Winds of change, developing a non-target plant bioassay employing field-based pesticide drift exposure: A case study with atrazine. Science of the Total Environment, 678, 239-252. https://doi.org/10.1016/j.scitotenv.2019.04.411

Brain, R. A., Perine, J., Cooke, C., Ellis, C. B., Harrington, P., Lane, A., Sullivan, C., & Ledson, M. (2017). Evaluating the effects of herbicide drift on non-target terrestrial plants: A case study with mesotrione. Environmental Toxicology and Chemistry, 36(9), 2465-2475. https://doi.org/10.1002/etc.3786

Brain, R. A., Teed, R. S., Bang, J., Thorbek, P., Perine, J., Peranginangin, N., Kim, M., Valenti, T., Chen, W., Breton, R. L., Rodney, S. I., & Moore, D. R. J. (2015). Risk assessment considerations with regard to the potential impacts of pesticides on endangered species. Integrated Environment Assessment and Management, 11(1), 102-117. https://doi.org/10.1002/ieam.1572

Briggs, G. G., Bromilow, A. A., & Evans, R. H. (1982). Relationships between lipophilicity and root uptake and translocation of non-ionised chemicals by barley. Pesticide Science, 13(5), 495-504. https://doi.org/10.1002/ps.2780130506

Briggs, G. G., Bromilow, A. A., Evans, R. H., & Williams, M. (1983). Relationships between lipophilicity and the distribution of non-ionised chemicals in barley shoots following uptake by the roots. Pesticide Science, 14(5), 492-500. https://doi.org/10.1002/ps.2780140506

Browne, A. (2000). ‘Judas’ of the eco-warriors spreads his gospel of doubt. Retrieved July 14, 2020 from https://www.theguardian.com/environment/2000/may/21/activists.uknews

Brühl, C. A., Guckenmus, B., Ebeling, M., & Barfknecht, R. (2011). Exposure reduction of seed treatments through dehusking behaviour of the wood mouse (Apodemus sylvaticus). Environmental Science and Pollution Research, 18(1), 31-37. http://doi.org/10.1007/s11356-010-0351-x

Carson, R. (1962). Silent Spring. Houghton Mifflin Company.

Cooper J, & Dobson, H. (2007). The benefits of pesticides to mankind and the environment. Crop Protection, 26(9), 1337-1348. https://doi.org/10.1016/j.cropro.2007.03.022

Covich, A. P., Palmer, M. A., & Crowl, T. A. (1999). The role of benthic invertebrate species in freshwater ecosystems. BioScience, 49(2), 119-127. http://doi.org/10.2307/1313537

Damalas, C. A. (2009). Understanding benefits and risks of pesticide use. Scientific Research and Essays, 4(10), 945-949. https://doi.org/10.5897/SRE.9000968

Ebert, E. (2004). Glufosinate Ammonium - Active Substance. Consideration on Appropriate Acute and Chronic Endpoints for Assessment of Risk to Wild Mammals. Bayer CropScience Inc., Research Triangle Park, NC. Bayer Report Code C045829.

Ehrlich, P. R., & Walker, B. (1998). Rivets and redundancy. BioScience, 48(5), 387. http://doi.org/10.2307/1313377

Federal Register. (1972). Environmental Protection Agency; Consolidated DDT Hearings; Opinion and Order of the Administrator. Federal Register, 37, 13369-13376.

Federal Register. (2007). Pesticides; Data Requirements for Conventional Pesticides, Technical Amendments, and Data Requirements for Biochemical and Microbial Pesticides; Final Rules. Federal Register, 72, 60934-60988.

Federal Register. (2020). Agencies; Fish and Wildlife Service. Retrieved June 25, 2020 from http://federalregister.gov/agencies/fish-and-wildlife-service.

Fletcher, J. S., Nellessen, J. E., & Pfleeger, T. G. (1994). Literature review and evaluation of the EPA food-chain (Kenaga) nomogram, an instrument for estimating pesticide residues on plants. Environmental Toxicology and Chemistry, 13(9), 1383-1391. https://doi.org/10.1002/etc.5620130902

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

Gianessi, L. P. (2009). Executive Summary of the Value of Insecticides in U.S. Crop Production. CropLife Foundation, Washington, D.C.

Gianessi, L. P. (2012). The Worldwide Importance of Pesticides for Crop Production. Presentation for CropLife Foundation, Washington, D.C.

Hoerger, F., & Kenaga, E. E. (1972). Pesticide Residues on Plants: Correlation of Representative Data as a Basis for Estimation of Their Magnitude in the Environment. In F. Coulston, & F. Korte (Eds.), Environmental Quality and Safety: Chemistry, Toxicology and Technology (pp. 9-28). George Thieme Publishers.

Koch, H., & Weisser, P. (1997). Exposure of honey bees during pesticide application under field conditions. Apidologie, 28(6), 439-447. https://doi.org/10.1051/apido:19970610

Lomborg, B. (2001). The Skeptical Environmentalist. Cambridge University Press.

Marrs, R. H., & Frost, A. J. (1997). A microcosm approach to the detection of the effects of herbicide spray drift in plant communities. Journal of Environmental Management, 50(4), 369-388. https://doi.org/10.1006/jema.1996.9984

McDougall, P. (2016). The Cost of New Agrochemical Product Discovery, Development, and Registration in 1995, 2000, 2005-8 and 2010-2014. R&D Expenditure in 2014 and Expectations for 2019. Retrieved July 7, 2020 from https://croplife.org/wp-content/uploads/2016/04/Cost-of-CP-report-FINAL.pdf

Moore, D. R. J., Fischer, D. L., Teed, R. S., & Rodney, S. I. (2010). A probabilistic risk assessment model for birds exposed to granular pesticides. Integrated Environmental Assessment and Management, 6(2), 260-272. https://doi.org/10.1897/IEAM_2009-021.1

Moore, D. R. J., Teed, R. S., Greer, C. D., Solomon, K. R., & Giesy, J. P. (2014). Refined avian risk assessment for chlorpyrifos. Reviews of Environmental Contamination and Toxicology, 231, 163-217. http://doi.org/10.1007/978-3-319-03865-0_6

Muñoz-Carpena, R., Ritter, A., & Fox, G. (2019). Comparison of empirical and mechanistic equations for vegetative filter strip pesticide mitigation in long-term environmental exposure assessments. Water Research, 165(8). http://doi.org/10.1016/j.watres.2019.114983

Ortiz-Santaliestra, M. E., Maia, J. P., Egea-Serrano, A., & Lopes, I. (2018). Validity of fish, birds and mammals as surrogates for amphibians and reptiles in pesticide toxicity assessment. Ecotoxicology, 27(7), 819-833. https://doi.org/10.1007/s10646-018-1911-y

Pimentel, D. (1997). Techniques for Reducing Pesticide Use: Economic and Environmental Benefits. John Wiley and Sons.

Prosser, P., & Hart, A. D. M. 2005. Assessing potential exposure of birds to pesticide-treated seeds. Ecotoxicology, 14(7), 679-691. https://doi.org/10.1007/s10646-005-0018-4

Rodney, S., & Kramer, V. (2020) Probabilistic assessment of nectar requirements for nectar-foraging honey bees. Apidologie, 51(2), 180-200. http://doi.org/10.1007/s13592-019-00693-w

Rodney, S., & Purdy, J. (2020). Dietary requirements of individual nectar foragers, and colony-level pollen and nectar consumption: A review to support pesticide exposure assessment for honey bees. Apidologie, 51(1), 163-179. http://doi.org/10.1007/s13592-019-00694-9

Roessink, I., Merga, L. B., Zweer, H. J., & Van den Brink, P. J. (2013). The neonicotinoid imidacloprid shows high chronic toxicity to mayfly nymphs. Environmental Toxicology and Chemistry, 32(5), 1096-1100. https://doi.org/10.1002/etc.2201

Rosenfeld, J. S. (2002). Functional redundancy in ecology and conservation. Oikos, 98(1), 156-162. https://doi.org/10.1034/j.1600-0706.2002.980116.x

Sabbagh, G. J., Fox, G. A., Kamanzi, A., Roepke, B., & Tang, J. -Z. (2009). Effectiveness of vegetative filter strips in reducing pesticide loading: Quantifying pesticide trapping efficiency. Journal of Environmental Quality, 38(2), 762-771. https://doi.org/10.2134/jeq2008.0266

Schriever, T. A., & Lytle, D. A. (2016). Convergent diversity and trait composition in temporary streams and ponds. Ecosphere, 7(5), 1-12. http://doi.org/10.1002/ecs2.1350

Schulz, R. (2004). Field studies on exposure, effects, and risk mitigation of aquatic nonpoint-source insecticide pollution: A review. Journal of Environmental Quality, 33(2), 419-448. https://doi.org/10.2134/jeq2004.4190

Suarez, M. L., Sanchez-Montoya, M. M., Gomez, R., Arce, M. I., del Campo, R., & Vidal-Abarca, M. R. (2016). Functional response of aquatic invertebrate communities along two natural stress gradients (water salinity and flow intermittence) in Mediterranean streams. Aquatic Science, 79(1). http://doi.org/10.1007/s00027-016-0475-2

Teske, M. E., Bird, S. L., Esterly, D. M., Ray, S. L., & Perry, S.G. (2002). A User’s Guide for Agdrift 2.0.05: A Tiered Approach for the Assessment of Spray Drift of Pesticides. Regulatory Version. C.D.I. Report No. 01-02. Prepared for Spray Drift Task Force c/o Stewart Agricultural Services, Inc. Macon, MO.

Trask, J. R., Williams, W. M., & Ritter, A. M. (2010). Overview of USEPA-OPP’s Terrestrial Risk Assessment Models. Prepared by Waterborne Environmental, Inc., Leesburg, VA for CropLife America, Washington, D.C.

Trask, J. R., Williams W. M., & Ritter, A. M. (2010). Options for Refining the Exposure Component of USEPA-OPP’s Terrestrial Risk Assessment Models. Prepared by Waterborne Environmental, Inc., Leesburg, VA for Croplife America, Washington, D.C.

United States Department of Agriculture. (2000). Conservation Buffers to Reduce Pesticide Losses. Natural Resources Conservation Service, U.S. Department of Agriculture, Washington, D.C.

United States Department of Agriculture. (2020). Agricultural Productivity in the U.S. Economic Research Service. U.S. Department of Agriculture, Washington D.C. Retrieved from https://www.ers.usda.gov/data-products/agricultural-productivity-in-the-us/

United States Environmental Protection Agency. (2000). Generic Estimated Environmental Concentration Model – Tier I Screening Model for Pesticide Aquatic Ecological Exposure Assessment, Version 2.0. Office of Pesticide Programs, U.S. Environmental Protection Agency, Washington, D.C. Retrieved July 13, 2020 from http://www.epa.gov/oppefed1/models/water/index.htm

United States Environmental Protection Agency. (2002). Guidance for Selecting Input Parameters in Modeling the Environmental Fate and Transport of Pesticides. Office of Pesticide Programs, U.S. Environmental Protection Agency, Washington, D.C. Retrieved June 25, 2020 from http://www.epa.gov/oppefed1/models/water/input_guidance2_28_02.htm

United States Environmental Protection Agency. (2003). Pesticide Root Zone Model Field and Orchard Crop Scenario Metadata. Office of Pesticide Programs, U.S. Environmental Protection Agency, Washington, D.C. Retrieved June 25, 2020 from http://www.epa.gov/oppefed1/models/water/index.htm

United States Environmental Protection Agency. (2004). Overview of the Ecological Risk Assessment Process in the Office of Pesticide Programs, U.S. Environmental Protection Agency: Endangered and Threatened Species Effects Determinations. Office of Pesticide Programs, U.S. Environmental Protection Agency, Washington, D.C. Retrieved July 13, 2020 from http://www.epa.gov/espp/consultation/ecorisk-overview.pdf

United States Environmental Protection Agency. (2006). Interim Reregistration Eligibility Decision for Methyl Parathion. Office of Pesticide Programs, U.S. Environmental Protection Agency, Washington, D.C. Retrieved June 15, 2020 from https://archive.epa.gov/pesticides/reregistration/web/pdf/methyl_parathion_red.pdf

United States Environmental Protection Agency. (2011). Evaluation Guidelines for Ecological Toxicity Data in the Open Literature. U.S. Environmental Protection Agency, Washington, D.C. Retrieved June 15, 2020 from https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/evaluation-guidelines-ecological-toxicity-data-open#guidance

United States Environmental Protection Agency. (2012). Guidance for Considering and Using Open Literature Toxicity Studies to Support Human Health Risk Assessment. Office of Pesticide Programs, U.S. Environmental Protection Agency, Washington, D.C. Retrieved June 15, 2020 from https://www.epa.gov/sites/production/files/2015-07/documents/lit-studies.pdf

United States Environmental Protection Agency. (2015). Compliance Monitoring Strategy for Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Office of Enforcement and Compliance Assurance, U.S. Environmental Protection Agency, Washington D.C. Retrieved July 7, 2020 from https://www.epa.gov/sites/production/files/2015-09/documents/fifra-cms.pdf

United States Environmental Protection Agency. (2016). Label Review Manual. Office of Pesticide Programs, U.S. Environmental Protection Agency, Washington, D.C. Retrieved July 14, 2020 from https://www.epa.gov/pesticide-registration/label-review-manual

United States Environmental Protection Agency. (2016). Refined Ecological Risk Assessment for Atrazine. Office of Pesticide Programs, U.S. Environmental Protection Agency, Washington D.C.

United States Environmental Protection Agency. (2017). Pesticide Registration Manual. Office of Pesticide Programs, U.S. Environmental Protection Agency, Washington, D.C. Retrieved July 7, 2020 from https://www.epa.gov/pesticide-registration/pesticide-registration-manual

United States Environmental Protection Agency. (2019). Directive to Prioritize Effects to Reduce Animal Testing. U.S. Environmental Protection Agency, Washington, D.C. Retrieved July 7, 2020 from https://www.epa.gov/sites/production/files/2019-09/documents/image2019-09-09-231249.pdf

United States Environmental Protection Agency. (2019). Overview of Risk Assessment in the Pesticide Program. Office of Pesticide Programs, U.S. Environmental Protection Agency, Washington, D.C. Retrieved July 7, 2020 from https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/overview-risk-assessment-pesticide-program

United States Environmental Protection Agency. (2020). About Pesticide Registration. U.S. Environmental Protection Agency, Washington, D.C. Retrieved July 7, 2020 from https://www.epa.govpesticide-registration/about-pesticide-registration#::text=Federal%20Pesticide%20Laws,-We%20regulate%20pesticides&text=These%20laws%20have%20been%20amended,to%20be%20registered%20by%20EPA

United States Environmental Protection Agency. (2020). New Approach Methods Work Plan: Reducing Use of Animals in Chemical Testing. U.S. Environmental Protection Agency, Washington, D.C. Retrieved July 7, 2020 from https://www.epa.gov/sites/production/files/2020-06/documents/epa_nam_work_plan.pdf

United States Environmental Protection Agency. (2020). Plant Assessment Tool (PAT) Version 1.0. User’s Guide and Technical Manual for Estimating Pesticide Exposure to Terrestrial, Wetland, and Aquatic Plants in EPA’s Listed Species Biological Evaluations. Office of Pesticide Products, U.S. Environmental Protection Agency, Washington, D.C.

United States Environmental Protection Agency. (2020). Revised Method for National Level Listed Species Biological Evaluations of Conventional Pesticides. Office of Pesticide Programs, U.S. Environmental Protection Agency, Washington, D.C.

United States Environmental Protection Agency. (2020). Summary of the Federal Insecticide, Fungicide, and Rodenticide Act. U.S Environmental Protection Agency, Washington, D.C. Retrieved July 7, 2020 from https://www.epa.gov/laws-regulations/summary-federal-insecticide-fungicide-and-rodenticide-act#::text=FIFRA%20defines%20the%20term%20'',from%20a%20use%20of%20a

United States Environmental Protection Agency, PMRA, Cal DPR. (2012). White Paper in Support of the Proposed Risk Assessment Process for Bees. Office of Pesticide Programs, U.S. Environmental Protection Agency, Washington, D.C.; Environmental Assessment Directorate, Pest Management Regulatory Agency, Health Canada, Ottawa, Canada; California Department of Pesticide Regulations, Sacramento, CA.

United States Environmental Protection Agency, PMRA, CDPR. (2014). Guidance for Assessing Pesticide Risks to Bees. Office of Pesticide Programs, U.S. Environmental Protection Agency, Washington, D.C; Environmental Assessment Directorate, Pest Management Regulatory Agency, Health Canada, Ottawa, Canada; California Department of Pesticide Regulations, Sacramento, CA. Retrieved June 27, 2020 from https://www.epa.gov/pollinator-protection/pollinator-risk-assessment-guidance

United States Fish and Wildlife Service. (1973). Endangered Species Act of 1973; As Amended through the 108th Congress. United States Fish and Wildlife Service, Washington, D.C.

Vecchia, A. V. (2018). Model Methodology for Estimating Pesticide Concentration Extremes Based on Sparse Monitoring Data. National Water Quality Program, U.S. Geological Survey, Bismarck, ND. Scientific Investigations Report 2017–5159. https://doi.org/10.3133/sir20175159

Whitfield-Aslund, M., Winchell, M., Bowers, L., McGee, S., Tang, J., Padilla, L., Greer, C., Knopper, L., & Moore, D. R. J. (2017). Ecological risk assessment for aquatic invertebrate communities exposed to imidacloprid as a result of labeled agricultural and non-agricultural uses in the United States. Environmental Toxicology and Chemistry, 36(5),1375-1388. http://doi.org/10.1002/etc.3655

Whitford, F., Pike, D., Johnson, B., & Blessing, A. (2008). Pesticide Benefits Assessment: EPA Balances Risks and Benefits. Purdue University, West Lafayette, IN. Retrieved July 7, 2020 from https://ppp.purdue.edu/wp-content/uploads/2016/08/PPP-78.pdf

Willson, M.F. (1972). Seed size preference in finches. The Wilson Bulletin, 84, 449-455.

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