21
Nov
EPA’s Deficient Pesticide Analysis Contributes to Ecological Decline
(Beyond Pesticides, November 21, 2022) Once again, the Environmental Protection Agency (EPA) has registered a new pesticide without performing a thorough review of its impacts on biodiversity as well as threatened and endangered species. Inpyrfluxam was registered in 2020 and only after being sued by the Center for Biological Diversity for failure to comply with the Endangered Species Act (ESA) did EPA commit to completing draft effects determinations by Fall 2022. Once again, EPA’s draft biological evaluation is incomplete and inadequate. EPA is accepting comments on its draft biological evaluation at Regulations.gov.Â
The agency’s draft effects assessment is flawed and incomplete. We share the details because it shows that EPA is out of step with the science and its regulatory responsibility when it comes a thorough review for ecosystem effects of pesticides. Â
The agency used fish early life stage (ELS) tests to estimate chronic fish toxicity. This is inappropriate. The fish ELS is a sub-chronic test of sensitive life stages. Although it is often used as a surrogate or predictor of chronic toxicity, it does not adequately address potential adverse effects on reproduction or transfer of the test chemical to eggs/offspring from parental exposure. Only a complete life-cycle test can satisfy the 40 CFR Part 158 requirements for a valid fish chronic toxicity test. An early life-stage test cannot be appropriately substituted. A full life-cycle test (OSCPP 850.1500) or medaka extended one-generation test (OSCPP 890.2200) is needed to correctly assess reproduction impairment and chronic toxicity from long-term exposures. Such chronic reproductive toxicity testing in fish is further warranted by the observation of reproductive impairment in another vertebrate taxon (bobwhite quail). Additionally, the reduced egg production in a non-monotonic dose response seen in the bobwhite quail reproduction study suggests the potential for an endocrine disrupting modality. The higher toxicity of inpyrfluxam to another bird species (zebra finch) in a sub-acute dietary study warrants a full reproduction test with this passerine species to fully assess serious risks posed to listed avian species. An Endocrine Disruptor Screening Program evaluation of inpyrfluxam has not been completed and is also necessary for an adequate endangered species consultation with the Services.Â
The lack of appropriate chronic toxicity and endocrine disruption data is especially worrisome given the recognized environmental persistence of inpyrfluxam. Further, the registration of inpyrfluxam should not have been approved in the first place with such important data missing from the ecological risk assessment. Without these data and with the somewhat marginal benefits of inpyrfluxam use, the agency cannot honestly conclude, as statutorily required, that the use of this fungicide does not pose an unreasonable risk. The agency should immediately suspend the uses of inpyrfluxam until data addressing the chronic reproductive toxicity in fish and birds are available and the Services are consulted on potential jeopardy to these taxa. The agency should be reminded that it should not make any registration decisions until a thorough ecological risk assessment has been completed and as mandated in the Endangered Species Act that the Services have been consulted for any may affect findings noted.Â
Beyond Pesticides has previously pointed out deficiencies in EPA’s ecological risk assessments for atrazine, fludioxonil, neonicotinoids, carbaryl and methomyl, indaziflam, pyrethroids, paraquat, glyphosate, and wood preservatives. In addition, the Center for Biological Diversity and others have successfully sued EPA for numerous failures to perform complete assessments of impacts of pesticides on threatened and endangered species. All this is occurring amid documented threats to biodiversity from the combined impacts of pesticides and climate change.Â
Letter to EPA Administrator:
Once again, EPA has registered a new pesticide without performing a thorough review of its impacts on threatened and endangered species. Inpyrfluxam was registered in 2020, and only after being sued by the Center for Biological Diversity for failure to comply with the Endangered Species Act (ESA) did EPA commit to completing draft effects determinations by Fall 2022. Once again, EPA’s draft biological evaluation is incomplete and inadequate. EPA is accepting comments on its draft biological evaluation at Regulations.gov.
The agency’s draft effects assessment of inpyrfluxam is flawed and incomplete. The agency used fish early life stage (ELS) tests to estimate chronic fish toxicity. This is inappropriate. The fish ELS is a sub-chronic test of sensitive life stages. Although it is often used as a surrogate or predictor of chronic toxicity, it does not adequately address potential adverse effects on reproduction or transfer of test chemical to eggs/offspring from parental exposure. Only a complete life-cycle test can satisfy the 40 CFR Part 158 requirements for a valid fish chronic toxicity test. An early life-stage test cannot be appropriately substituted. A full life cycle test (OSCPP 850.1500) or medaka extended one-generation test (OSCPP 890.2200) is needed to correctly assess reproduction impairment and chronic toxicity from long term exposures. Such chronic reproductive toxicity testing in fish is further warranted by the observation of reproductive impairment in another vertebrate taxon (bobwhite quail). Additionally, the reduced egg production in a non-monotonic dose response seen in the bobwhite quail reproduction study suggests the potential for an endocrine disrupting modality. The higher toxicity of inpyrfluxam to another bird species (zebra finch) in a sub-acute dietary study warrants a full reproduction test with this passerine species to fully assess serious risks posed to listed avian species. An Endocrine Disruptor Screening Program evaluation of inpyrfluxam has not been completed and is also necessary for an adequate endangered species consultation with the Services.
The lack of appropriate chronic toxicity and endocrine disruption data is especially worrisome given the recognized environmental persistence of inpyrfluxam. Further, the registration of inpyrfluxam should not have been approved in the first place with such important data missing from the ecological risk assessment. Without these data and with the somewhat marginal benefits of inpyrfluxam use, the agency cannot honestly conclude as statutorily required that the use of this fungicide does not pose an unreasonable risk. The agency should immediately suspend the uses of inpyrfluxam until data addressing the chronic reproductive toxicity in fish and birds are available and the Services are consulted on potential jeopardy to these taxa. The agency should not make any registration decisions until a thorough ecological risk assessment has been completed and as mandated in the Endangered Species Act that the Services have been consulted for any may affect findings noted.
Beyond Pesticides has previously pointed out deficiencies in EPA’s ecological risk assessments for atrazine, fludioxonil, neonicotinoids, carbaryl and methomyl, indaziflam, pyrethroids, paraquat, glyphosate, and wood preservatives. In addition, the Center for Biological Diversity and others have successfully sued EPA for numerous failures to perform complete assessments of impacts of pesticides on threatened and endangered species. All this is occurring amid documented threats to biodiversity from the combined impacts of pesticides and climate change.
EPA must cancel the registration of inpyrfluxam and perform complete biological evaluations of all pesticides.
Thank you.
Letter to U.S. Representative and Senators:
Once again, the Environmental Protection Agency (EPA) has registered a new pesticide without performing a thorough review of its impacts on threatened and endangered species. Inpyrfluxam was registered in 2020, and only after being sued by the Center for Biological Diversity for failure to comply with the Endangered Species Act (ESA) did EPA commit to completing draft effects determinations by Fall 2022. Once again, EPA’s draft biological evaluation is incomplete and inadequate. EPA is accepting comments on its draft biological evaluation at Regulations.gov.
The agency’s draft effects assessment of inpyrfluxam is flawed and incomplete. The agency used fish early life stage (ELS) tests to estimate chronic fish toxicity. This is inappropriate. The fish ELS is a sub-chronic test of sensitive life stages. Although it is often used as a surrogate or predictor of chronic toxicity, it does not adequately address potential adverse effects on reproduction or transfer of test chemical to eggs/offspring from parental exposure. Only a complete life-cycle test can satisfy the 40 CFR Part 158 requirements for a valid fish chronic toxicity test. An early life-stage test cannot be appropriately substituted. A full life cycle test (OSCPP 850.1500) or medaka extended one-generation test (OSCPP 890.2200) is needed to correctly assess reproduction impairment and chronic toxicity from long term exposures. Such chronic reproductive toxicity testing in fish is further warranted by the observation of reproductive impairment in another vertebrate taxon (bobwhite quail). Additionally, the reduced egg production in a non-monotonic dose response seen in the bobwhite quail reproduction study suggests the potential for an endocrine disrupting modality. The higher toxicity of inpyrfluxam to another bird species (zebra finch) in a sub-acute dietary study warrants a full reproduction test with this passerine species to fully assess serious risks posed to listed avian species. An Endocrine Disruptor Screening Program evaluation of inpyrfluxam has not been completed and is also necessary for an adequate endangered species consultation with the Services.
The lack of appropriate chronic toxicity and endocrine disruption data is especially worrisome given the recognized environmental persistence of inpyrfluxam. Further, the registration of inpyrfluxam should not have been approved in the first place with such important data missing from the ecological risk assessment. Without these data and with the somewhat marginal benefits of inpyrfluxam use, the agency cannot honestly conclude as statutorily required that the use of this fungicide does not pose an unreasonable risk. The agency should immediately suspend the uses of inpyrfluxam until data addressing the chronic reproductive toxicity in fish and birds are available and the Services are consulted on potential jeopardy to these taxa. The agency should be reminded that it should not make any registration decisions until a thorough ecological risk assessment has been completed and as mandated in the Endangered Species Act that the Services have been consulted for any may affect findings noted.
Beyond Pesticides has previously pointed out deficiencies in EPA’s ecological risk assessments for atrazine, fludioxonil, neonicotinoids, carbaryl and methomyl, indaziflam, pyrethroids, paraquat, glyphosate, and wood preservatives. In addition, the Center for Biological Diversity and others have successfully sued EPA for numerous failures to perform complete assessments of impacts of pesticides on threatened and endangered species. All this is occurring amid documented threats to biodiversity from the combined impacts of pesticides and climate change.
Please ensure through your oversight that EPA fulfills its responsibilities according to law. EPA must cancel the registration of inpyrfluxam and perform complete biological evaluations of all pesticides.
Thank you.
Your action is even more effective if you submit your comment at Regulations.gov following this link.
Please also submit a comment to EPA at this link at Regulations.gov. See suggested language that you can copy into Regulations.gov. Adding a personal comment of concern at the beginning of the comment is helpful but not necessary.
Suggested language for a comment at Regulations.gov:
Once again, EPA has registered a new pesticide without performing a thorough review of its impacts on threatened and endangered species. Inpyrfluxam was registered in 2020, and only after being sued by the Center for Biological Diversity for failure to comply with the Endangered Species Act (ESA) did EPA commit to completing draft effects determinations by Fall 2022. Once again, EPA’s draft biological evaluation is incomplete and inadequate. EPA is accepting comments on its draft biological evaluation at Regulations.gov.Â
The agency’s draft effects assessment of inpyrfluxam is flawed and incomplete. The agency used fish early life stage (ELS) tests to estimate chronic fish toxicity. This is inappropriate. The fish ELS is a sub-chronic test of sensitive life stages. Although it is often used as a surrogate or predictor of chronic toxicity, it does not adequately address potential adverse effects on reproduction or transfer of the test chemical to eggs/offspring from parental exposure. Only a complete life-cycle test can satisfy the 40 CFR Part 158 requirements for a valid fish chronic toxicity test. An early life-stage test cannot be appropriately substituted. A full life cycle test (OSCPP 850.1500) or medaka extended one-generation test (OSCPP 890.2200) is needed to correctly assess reproduction impairment and chronic toxicity from long-term exposures. Such chronic reproductive toxicity testing in fish is further warranted by the observation of reproductive impairment in another vertebrate taxon (bobwhite quail). Additionally, the reduced egg production in a non-monotonic dose response seen in the bobwhite quail reproduction study suggests the potential for an endocrine disrupting modality. The higher toxicity of inpyrfluxam to another bird species (zebra finch) in a sub-acute dietary study warrants a full reproduction test with this passerine species to fully assess serious risks posed to listed avian species. An Endocrine Disruptor Screening Program evaluation of inpyrfluxam has not been completed and is also necessary for an adequate endangered species consultation with the Services.Â
The lack of appropriate chronic toxicity and endocrine disruption data is especially worrisome given the recognized environmental persistence of inpyrfluxam. Further, the registration of inpyrfluxam should not have been approved in the first place with such important data missing from the ecological risk assessment. Without these data and with the somewhat marginal benefits of inpyrfluxam use, the agency cannot honestly conclude, as statutorily required, that the use of this fungicide does not pose an unreasonable risk. The agency should immediately suspend the uses of inpyrfluxam until data addressing the chronic reproductive toxicity in fish and birds are available and the Services are consulted on potential jeopardy to these taxa. The agency should not make any registration decisions until a thorough ecological risk assessment has been completed and as mandated in the Endangered Species Act that the Services have been consulted for any may affect findings noted.Â
Beyond Pesticides has previously pointed out deficiencies in EPA’s ecological risk assessments for atrazine, fludioxonil, neonicotinoids, carbaryl and methomyl, indaziflam, pyrethroids, paraquat, glyphosate, and wood preservatives. In addition, the Center for Biological Diversity and others have successfully sued EPA for numerous failures to perform complete assessments of impacts of pesticides on threatened and endangered species. All this is occurring amid documented threats to biodiversity from the combined impacts of pesticides and climate change.Â
EPA must cancel the registration of inpyrfluxam and perform complete biological evaluations of all pesticides.Â
Thank you.Â
