{"id":36895,"date":"2024-11-05T00:01:04","date_gmt":"2024-11-05T05:01:04","guid":{"rendered":"https:\/\/beyondpesticides.org\/dailynewsblog\/?p=36895"},"modified":"2024-11-05T15:07:55","modified_gmt":"2024-11-05T20:07:55","slug":"evaluation-of-epa-safety-data-on-neonicotinoid-insecticides-identifies-scientific-failures","status":"publish","type":"post","link":"https:\/\/beyondpesticides.org\/dailynewsblog\/2024\/11\/evaluation-of-epa-safety-data-on-neonicotinoid-insecticides-identifies-scientific-failures\/","title":{"rendered":"Evaluation of EPA Safety Data on Neonicotinoid Insecticides Identifies Scientific Failures"},"content":{"rendered":"

(Beyond Pesticides<\/em>, November 5, 2024) Published in the journal Frontiers in Toxicology,<\/em><\/a> a recent study<\/a> uncovers serious flaws in the pesticide registration process at the U.S. Environmental Protection Agency (EPA) with an in-depth evaluation of the agency\u2019s failure to protect the public from the harmful effects of five neonicotinoid (neonic) insecticides\u2014as mandated by the Federal Insecticide, Fungicide, and Rodenticide Act<\/a><\/em> (FIFRA) and amendments, including Food Quality Protection Act<\/em><\/a> (FQPA) of 1996. This coincides with EPA’s ongoing review to renew their approval for the next 15 years (set to be announced<\/a> in 2025). The report is based on the first comprehensive assessment of unpublished rodent-based Developmental Neurotoxicity (DNT) studies, conducted between 2000-2003 and submitted by pesticide manufacturers as part of the registration process. <\/p>\n

All five neonicotinoids evaluated\u2014acetamiprid<\/a>, clothianidin<\/a>, imidacloprid<\/a>, thiacloprid<\/a>, and thiamethoxam<\/a>\u2014are associated with significant shrinkage of brain tissue at the highest dosage, according to EPA data reports (see acetamiprid<\/a>, clothianidin<\/a>, imidacloprid<\/a>, thiacloprid<\/a>, and thiamethoxam<\/a>). However, with little or no data regarding the chemicals\u2019 impacts at low and mid-level dosages, EPA has either failed to find a \u201cNo Observed Adverse Effect Level\u201d (NOAEL) or, seemingly at random, set the NOAEL at the mid-level dosage. The evaluation suggests that perinatal exposure to neonicotinoids and their metabolites results in nicotine-like neurotoxic effects in rodent studies, concluding that, \u201c… the exposure limits set by EPA for human exposure are either not protective or not supported by available neurotoxicity data.\u201d The study also finds that the agency ignored significant adverse effects, allowed DNT studies that did not conform with scientific protocols, and permitted \u201cneonicotinoid registrants to unduly influence agency decision-making.\u201d\u00a0<\/p>\n

[The research was conducted by Jennifer Sass, PhD, senior scientist at Natural Resources Defense Council; Nathan Donley, PhD, environmental health science director at the Center for Biological Diversity; and, Bill Freese, science director at the Center for Food Safety. A press release<\/a> on the evaluations notes, \u201cOur study contributes to the growing body of evidence suggesting that neonicotinoids are hazardous to the developing human nervous system and should be avoided just as mothers abstain from smoking during pregnancy. EPA must act to reduce the use of and human exposure to these toxic insecticides.\u201d]<\/p>\n

While the authors conclude that EPA regulatory changes are needed to better protect public health from developmental neurotoxic neonicotinoids, many public health and environmental advocates interpret the results as a signal\u2014a need for a major shift that questions the registration of harmful pesticides, which can be replaced by organic management practices and organic-compatible production inputs. These advocates point to the study\u2019s findings as identifying a fundamentally broken regulatory system in the face of the existential health, biodiversity, and climate crises stemming from petrochemical pesticide use, including highly toxic neonicotinoid insecticides. [Additionally, read more about recent U.S. Supreme Court decisions impacting environmental regulatory authority here: Daily News<\/a> on Chevron decision, Daily News<\/a> on Sackett<\/em> decision<\/a>, and the Clean Water Act<\/em> here<\/a>].<\/p>\n

Background<\/em><\/p>\n

Neonics are among the most widely used insecticides in the world, with the most common form of application as a treatment of seeds before dispersal. According to the report, at least 150 million acres were planted<\/a> with neonic-treated seeds in 2012, which is six times the amount of land treated with the top ten insecticides combined in 2001<\/a>. Outside of agricultural applications, neonics are commonly applied to parks and gardens, to pets as a flea treatment, and to control bed bug infestations. The result of such widespread use has led to rampant contamination in the food supply, human breast milk, and amniotic and cerebrospinal fluids. (See here<\/a>, here<\/a>, and here<\/a>). Neonicotinoids have been linked to breast cancer<\/a> by stimulating excess estrogen production, known to occur during the development of progressive hormone-dependent breast cancer. Due to their widespread use, neonicotinoids commonly contaminate water sources, including rivers and groundwater. This cumulative presence suggests, according to the authors, that children may be exposed at multiple developmental stages, including prenatally, through breastfeeding or formula mixed with contaminated tap water, and during childhood through food and water consumption. Given the likelihood of exposure, the authors argue that it is essential to sustain and enhance monitoring programs that identify pesticide residues in food, water, and biological samples. Furthermore, to address regular exposure to neonicotinoids, especially during critical early life stages, the study results suggest that risk assessments and regulatory decisions must adhere to (and ideally surpass) the safety standards established by current federal pesticide regulations.<\/p>\n

EPA employs DNT studies with rodents under established guidelines (see here<\/a> and here<\/a>) to evaluate the risks that pesticides may pose during the early development of the brain and nervous system, determine dose-response relationships, and set regulatory exposure limits. The agency then, based on the data provided, sets acute (short-term) and chronic (long-term) exposure limits by identifying a No Observed Adverse Effect Level (NOAEL). A 100-fold uncertainty factor is then applied to the NOAEL to account for differences between animals and humans and the uncertainty associated with individual variability in humans. However, this approach does not fully consider the increased vulnerability of the developing brain when exposure occurs during fetal growth or infancy. These stages are critical periods when the brain\u2019s structure is being formed via cell growth, differentiation, axon and synapse development, and cell migration. This damage is often irreversible due to the limited capacity for repair during these complex and fragile developmental processes.<\/p>\n

FQPA mandates that EPA consider the increased susceptibility of infants and children, including differences in neurological development and potential in-utero exposure to pesticides, to ensure “reasonable certainty of no harm” from all forms of pesticide exposure, including dietary and other known sources. A protective, although arbitrary, measure of FQPA is the 10X-fold child safety factor, which aims<\/a> to reduce permissible exposure levels to account for children\u2019s vulnerability to developmental toxins. Additionally, FQPA requires cumulative risk assessments for pesticides with shared mechanisms of toxicity. By law, EPA can reduce or eliminate this safety factor only if reliable data demonstrate that doing so would not compromise the safety of infants and children. Despite this mandate, EPA has often reduced or removed the child safety factor in its pesticide evaluations, including for neonicotinoids. (See here<\/a>, here<\/a>, and see Daily News<\/a> for one recent example of EPA failure to apply children\u2019s safety factor here<\/a>, specific to acephate).<\/p>\n

Study Methodology<\/em><\/p>\n

The report evaluates EPA\u2019s Data Evaluation Records, in which data for five unpublished DNT studies with highly defined protocols were previously analyzed by EPA staff. (After feeding female rats different doses of pesticides during pregnancy and lactation, labs contracted by pesticide manufacturers administer a variety of morphological, neurological, and behavioral tests from birth to 60 days old).<\/p>\n

Among the many irregularities that the report identifies:<\/p>\n