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Pyrethroid Registration: Review and Updates Daniel Dawson, Phd AMCA Legislative and Regulatory Committee Chemical Control Subcommittee Talk Outline

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Pyrethroid Registration: Review and Updates Daniel Dawson, Phd AMCA Legislative and Regulatory Committee Chemical Control Subcommittee Talk Outline Pyrethroid Registration: Review and Updates Daniel Dawson, PhD AMCA Legislative and Regulatory Committee Chemical Control Subcommittee Talk Outline Pyrethroid Overview Re-registration Registration Food Quality Protection Act Safety Factor Pyrethroids Synthetic pyrethrins Natural pesticides derived from chrysanthemums Neurotoxic Mode of Action Sodium channel blocker Paralyzes effected organism Toxic to arthropods Generally of low toxicity to vertebrates Can be toxic to fish Pyrethrin I Pyrethroids Pyrethrins degrade rapidly via solar radiation Pyrethroids chemically altered Be more resistant to solar degredation Resmethrin: Class 1 Pyrethroid Increase bio-activity Useful for Agricultural production Pest control Vector risk Changes bring increased risks Humans Cypermethrin: Class 2 Pyrethroid Non-target species Cyano-group Pyrethroid Use >3500 registered products Pets Treated Clothing Agriculture Mosquito Control Permethrin Resmethrin D-Phenothrin Re-registration As part of the Federal Insecticide Fungicide, and Rodenticide Act (FIFRA): Pesticides registered before 1984 had to be reviewed Ensure compliance with scientific and regulatory standards Authorized reregistration reviews 1988 Scientific studies Input from stakeholders Summarized in Reregistration Eligibility Decisions (REDs) Completed some 384 “cases” of pesticides by 2008 Concurrently, the Food Quality Protection Act (FQPA) required the reassessment tolerances of pesticides in food for human safety Completed 99% of tolerance assessment in 2006 Re-registration Process for implementing REDs Ensure required risk mitigation determined in review is reflected on labels Each product in a RED is individually considered Data Labeling If meets standards, may be reregistered If not, may be amended, suspected, or canceled. Registration Review Following registration and/or re-registration, EPA is mandated to review pesticides at least every 15 years to determine if they continue to meet FIFRA standards For all pesticides registered as of 2007, they have until 2022 to review their registration 10 pyrethrins, pyrethroids and synergists were registered before 1984, and had re-registration reviews by 2008. Pyrethroids, Pyrethrins and Synergists began registration review between 2010-2012 Registration Review Parts Ecological Risk Assessment Some pesticides reviewed as groups if they share Structure Chemical class Mode of action Human Health Risk Assessment Conducted individually Food Quality Protection Act Safety Factor Review Registration review: Pyrethroids Proposed interim decisions for 5 pyrethroids (As of Spring, 2020) Cyphenothrin Imiprothrin Tetramethrin Flumethrin Momfluorothrin Registration Review: Pyrethroids Ecological Risk Mitigation Proposal 8 pyrethroids/pyrethrins in 2016 23 pyrethroids/pyrethrins in 2019 Assessed as a class to “increase efficiency and consistency” Reduce spray drift Reduce runoff Promote soil conservation practices Registration Review: Pyrethroids Human Health Risk Assessments Conducted individually Risk assessments released in 2016-2018 Re-evaluated FQPA Safety Factor 2011 2019 Pyrethroids/Pyrethrins under Review Docket Chemical Status Number Special Docket for the Pyrethroids and EPA-HQ-OPP-2008-0331 Accepting comments on the Pyrethroids and Pyrethrins Pyrethrins Ecological Risk Mitigation Proposal and the FQPA Safety Factor until 1/13/20 (11/12/19) Allethrins EPA-HQ-OPP-2010-0022 Interim decision (12/24/14) Bifenthrin EPA-HQ-OPP-2010-0384 Draft ecological assessment (11/29/16) Draft human health risk assessment (12/15/17) Cyfluthrin and beta-cyfluthrin EPA-HQ-OPP-2010-0684 Draft ecological assessment (11/29/16) Draft human health risk assessment (12/15/17) Cypermethrin (alpha and zeta) EPA-HQ-OPP-2012-0167 Draft ecological assessment (11/29/16) Draft human health risk assessment (2/28/18) Cyphenothrin EPA-HQ-OPP-2009-0842 Accepting comments on the proposed interim decision until 1/13/20 (11/12/19) Draft ecological assessment (11/29/16) Draft human health risk assessment(5/25/17) d-phenothrin EPA-HQ-OPP-2011-0539 Draft ecological assessment (11/29/16) Draft human health assessment (11/29/16) Deltamethrin EPA-HQ-OPP-2009-0637 Draft ecological assessment (11/29/16) Draft human health risk assessment (8/03/17) *Esfenvalerate EPA-HQ-OPP-2009-0301 Draft ecological assessment (11/29/16) Draft human health risk assessment (8/03/17) Etofenprox EPA-HQ-OPP-2007-0804 Draft ecological assessment (11/29/16) Draft human health risk assessment (9/13/17) Fenpropathrin EPA-HQ-OPP-2010-0422 Draft ecological assessment (11/29/16) Draft human health assessment (11/29/16) Pyrethroids/Pyrethrins under Review Flumethrin EPA-HQ-OPP-2016-0031 Accepting comments on the proposed interim decision until 1/13/20 (11/12/19) Draft ecological assessment (11/29/16) Draft human health risk assessment (5/24/18) Gamma-cyhalothrin EPA-HQ-OPP-2010-0479 Draft ecological assessment (11/29/16) Draft human health risk assessment (9/13/17) Imiprothrin EPA-HQ-OPP-2011-0692 Accepting comments on the proposed interim decision Draft ecological assessment (11/29/16) Draft human health assessment (11/29/16) Lambda-cyhalothrin EPA-HQ-OPP-2010-0480 Draft ecological assessment (11/29/16) Draft human health risk assessment (9/13/17) Momfluorothrin EPA-HQ-OPP-2015-0752 Accepting comments on the proposed interim decision until 1/13/20 (11/12/19) Draft ecological assessment (11/29/16) Draft human health assessment (11/29/16) Permethrin EPA-HQ-OPP-2011-0039 Draft ecological assessment (11/29/16) Draft human health risk assessment (9/13/17) Prallethrin EPA-HQ-OPP-2011-1009 Draft ecological assessment (11/29/16) Draft human health assessment (11/29/16) Pyrethrins EPA-HQ-OPP-2011-0885 Draft ecological assessment (11/29/16) Draft human health risk assessment (9/13/17) Resmethrin EPA-HQ-OPP-2010-0306 Ingredient canceled Tau-fluvalinate EPA-HQ-OPP-2010-0915 Draft ecological assessment (11/29/16) Draft human health assessment (11/29/16) Tefluthrin EPA-HQ-OPP-2012-0501 Draft ecological assessment (11/29/16) Draft human health assessment (11/29/16) Tetramethrin EPA-HQ-OPP-2011-0907 Accepting comments on the proposed interim decision until 1/13/20 (11/12/19) Draft ecological assessment (11/29/16) Draft human health assessment (11/29/16) Tralomethrin EPA-HQ-OPP-2012-0425 Registration review decision completed Evaluation of the FQPA Safety Factor Food Quality Protection Act Requires that default safety factors are applied to chemicals to account for Interspecies differences (in-vivo toxicological assays are conducted on lab animals) Intraspecies variation (children vs adults, female vs male, etc) Also requires that an additional 10X interspecies safety factor to be protective of children and neo-natal toxicity Typically broken up into two parts(on log scale), including 3.16 X for Toxicokinetics(TK) 3.16 X for Toxicodynamics(TD) Can adjust safety factor if reliable data shows revised factor would be sufficiently protective Data-derived Extrapolation factor (DDEF) Quick aside: Toxicodynamics and Toxicokinetics Toxicodynamics: what the chemical does to the body Pharmacological effects (i.e., intended therapy) Toxicity (i.e., intended/unintended harm to body systems) Toxicokinetics: What the body does to the chemical Characterized by: Measured/modeled chemical concentration in tissue Where does chemical end up and how fast after exposure? Evaluation of the FQPA Safety Factor Previous review (2011) had resulted in 3x reduced to 1X for TD (toxicological mechanism and affects sufficiently similar between adults and children) Retention of 3x for TK(2011), based on higher modeled concentrations in tissues of juvenile rats, analogs for young children (<6 years old) New analysis convinced EPA that Infants/children are NOT more sensitive than adults 3X can be reduced to 1X for TK (2019) How was this determined? EPA white paper* says: “Based on a review of the available guideline and literature studies as well as data from the Council for the Advancement of Pyrethroid Human Risk Assessment (CAPHRA) program, the Agency concludes that the PK contribution to the FQPA factor is also 1X for adults, including women of child-bearing age, and children. Therefore, the total FQPA safety factor for pyrethroids can be reduced to 1X for all populations.” *USEPA Office of Pesticide Programs’ Re-Evaluation of the FQPA Safety Factor for Pyrethroids: Updated Literature and CAPHRA : Program Data Review (2019) https://www.epa.gov/sites/production/files/2019-08/documents/2019-pyrethroid-fqpa-caphra.pdf Council for the Advancement of Pyrethroid Human Risk Assessment (CAPHRA)? Following the reduction of the PD SF in 2011, EPA said: Some evidence for “higher sensitivity” to pyrethroids to juveniles following high doses Not enough data for risk assessment purposes Requested additional study designs/protocols to quantify differences in sensitivity Pyrethroid registrants formed Council for the Advancement of Pyrethroid Human Risk Assessment (CAPHRA) Develop research program to fill in data gap FQPA Safety Factor Evaluation Systematic Review(2019): Intensive literature review to assess for informative studies Found no new studies that could be used to inform guidelines CAPHRA TD: Conducted several rounds of studies; all found to be insufficiently informative to change previous ruling of 1x safety factor TK: Developed generic human Physiologically-based Toxicokinetic Model (PBTK) that can be parameterized for all pyrethroids, and for adults
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