EPA Must Review Complete Data for All Pesticides

EPA is proposing “streamlined proposed registration review decisions for several biopesticides.” Because EPA considers the four “biopesticides” to be “low risk,” “[t]he Agency is proposing that no further registration review is necessary for these biopesticides at this time.” Although the biopesticides listed in EPA's proposal for streamlining the registration review process for "low risk biopesticides" can be considered relatively low risk compared to conventional pesticides, the precedent for relying on the original or previous registration data and review is troublesome.

>> Tell EPA to do full registration reviews for all pesticides. 

The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires that the Environmental Protection Agency (EPA) conduct a registration review of all registered pesticides every 15 years. EPA explains, “[S]cience is constantly evolving, and new scientific information can come to light at any time and change our understanding of potential effects from pesticides.”

The four biopesticides to which this proposal pertains are alpha methyl mannoside (a plant growth regulator to improve the growth of a range of crops); Duddingtonia flagrans strain IAH 1297 (to break the cycle of parasitic nematode infections in grazing animals); Pepino mosaic virus, strain CH2, isolate 1906 (to protect greenhouse tomatoes from other viruses); and sheep fat (to repel animals like deer from ornamentals, trees, shrubs, and other plants). When considering the listed biopesticides in the proposal, EPA's summaries are predominantly dependent on limited actual data, data waiver request rationales, and purported absence of new data or adverse incidents reported. The absence of adverse effect evidence is not evidence of no adverse effects.

For alpha methyl mannoside, all human health data requirements were satisfied by a combination of data, waiver rationales, and the bridging of information from guar gum where high concentrations of mannose polymers are present. For ecological effects, all nontarget toxicology data requirements have been satisfied through guideline studies that demonstrated low acute toxicity for birds, mammals, aquatic organisms, invertebrates, and plants. EPA has concluded that adverse effects are not anticipated to birds, mammals, freshwater fish, aquatic invertebrates, insects, and nontarget plants. Curiously, the agency also determined that effects to federally listed threatened and endangered species and their designated critical habitats are not expected from these uses. However, the mode of action for alpha methyl mannoside, as a plant growth regulator, is to stimulate growth of treated plants. It is unclear why stimulating the growth of listed plant species, if exposed, or plants in the critical habitat of a listed species either plant or animal, if exposed, would not be potentially problematic or negatively affected by excessive growth. This seems worthy of more in-depth consideration as many herbicides function by excessive growth stimulation of target weeds, which can pose serious risks to nontarget plants.

For Duddingtonia flagrans strain IAH 1297, the registrant requested consideration of the history of safe use, the global ubiquity of D. flagrans, and the rationale based on literature sources to satisfy the data requirements for avian toxicity, wild mammal toxicity, aquatic organism testing, nontarget plant testing, and nontarget insect testing. EPA accepted the data waiver requests.

Similarly for Pepino mosaic virus, strain CH2, isolate 1906, scientific rationale was submitted and accepted to satisfy data requirements for Avian oral, Avian inhalation, Wild mammals, Freshwater fish, Freshwater invertebrates, Estuarine/marine fish and invertebrates, Nontarget insects, Honey bees, and Nontarget Plant toxicity/pathogenicity testing. Additionally, some nontarget plant testing, persistence in soil, persistence in water, algal toxicity, duckweed growth inhibition, and vegetative vigor studies were submitted. The results from the nontarget plant testing study are considered supplemental due to several deficiencies in the study, and it is not robust enough to conclude a lack of hazard for nontarget plants. The aquatic plant studies did not adequately describe the positive controls used, why the virus was not detectable at the start of the experiments, and did not describe the concentration (lg/L) of Pepino mosaic virus, strain CH2, isolate 1906 treatment in the Algal toxicity test which may have caused minimal growth inhibition.

EPA distinguishes three classes of biopesticides—biochemical, microbial, and plant-incorporated protectants (PIPs). The agency says, “Because it is sometimes difficult to determine whether a substance meets the criteria for classification as a biochemical pesticide, EPA has established a special committee to make such decisions.” “Biopesticides” are often assumed to be safer than “conventional” pesticides because they are assumed to be “natural.” However, EPA's definition of biopesticides—"derived from such natural materials as animals, plants, bacteria, and certain minerals”—does not mean that they are “natural.” Many of them would not qualify as “nonsynthetic” inputs in organic farming because the organic law requires consideration of manufacturing processes. Since some biopesticides—for example, pheromones—occur in minute quantities naturally, they are produced through chemical synthesis for commercial use. Such synthetic chemicals must be recommended by the National Organic Standards Board before they can be used in organic production and processing. Some microbial pesticides and PIPs would not be allowed because they result from genetic engineering.

Although the biopesticides listed in EPA's proposal for streamlining the registration review process for "low risk biopesticides" can be considered relatively low risk compared to conventional pesticides, the precedent for relying on the original or previous registration data and review is troublesome. EPA's rationale for registration review—that “science is constantly evolving, and new scientific information can come to light at any time and change our understanding of potential effects from pesticides,” should guide the agency in its decisions—especially when previous decisions have depended on limited actual data, data waiver request rationales, and purported absence of new data or adverse incidents reported. 

>> Tell EPA to do full registration reviews for all pesticides. 

The target for this Action is the U.S. Environmental Protection Agency, via comments through Regulations.gov.

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Letter to EPA:

Although biopesticides in the proposal for streamlining the registration review process for "low risk biopesticides" can be considered low risk compared to conventional pesticides, the precedent for relying on the original or previous registration data and review is unacceptable.

The Federal Insecticide, Fungicide, and Rodenticide Act requires that EPA conduct a registration review of all registered pesticides every 15 years. EPA states, “[S]cience is constantly evolving, and new scientific information can come to light at any time and change our understanding of potential effects from pesticides.”

EPA’s summaries concerning Alpha methyl mannoside; Duddingtonia flagrans strain IAH 1297; Pepino mosaic virus, strain CH2, isolate 1906; and sheep fat are predominantly dependent on limited actual data, data waiver request rationales, and purported absence of new data or reported adverse incidents. Absence of adverse effect evidence is not evidence of no adverse effects.

All human health data requirements for alpha methyl mannoside were satisfied by a combination of data, waiver rationales, and data from guar gum where high concentrations of mannose polymers are present. EPA concluded from guideline studies that adverse effects are not anticipated to birds, mammals, freshwater fish, aquatic invertebrates, insects, and nontarget plants. Although the agency also determined that effects to federally listed threatened and endangered species and their designated critical habitats are not expected from these uses, the mode of action as a plant growth regulator is to stimulate growth of treated plants. It is unclear why stimulating growth of listed plant species or plants in a critical habitat of a listed species, either plant or animal, would not result in negative impacts. This seems worthy of more in-depth consideration, as many herbicides function by excessive growth stimulation of target weeds, posing serious risks to nontarget plants.

For Duddingtonia flagrans strain IAH 1297, the registrant requested consideration of the history of safe use, the global ubiquity of D. flagrans, and a rationale based on literature sources to satisfy the data requirements for avian toxicity, wild mammal toxicity, aquatic organism testing, nontarget plant testing, and nontarget insect testing. EPA accepted the data waiver requests.

Similarly for Pepino mosaic virus, strain CH2, isolate 1906, scientific rationale was accepted to satisfy data requirements for avian oral, avian inhalation, wild mammals, freshwater fish, freshwater invertebrates, estuarine/marine fish and invertebrates, nontarget insects, honey bees, and nontarget plant toxicity/pathogenicity testing. Some nontarget plant testing, persistence in soil, persistence in water, algal toxicity, duckweed growth inhibition, and vegetative vigor studies were submitted. The nontarget plant testing study has several deficiencies and is insufficient to support a lack of hazard for nontarget plants. The aquatic plant studies did not adequately describe the positive controls used, why the virus was not detectable at the start of the experiments, and did not describe the concentration of the treatment in the algal toxicity test which may have caused minimal growth inhibition.

The EFSA 2021 peer review of the sheep fat risk assessment found toxicity data were not available for any group of nontarget organisms. A low acute and chronic risk to birds and mammals was presumed. Toxicity data to assess the chronic risk to aquatic organisms was deemed unnecessary.

Although these biopesticides may be considered low risk compared to conventional pesticides, relying on the original or previous registration data and review is problematic. Science is constantly evolving, and new scientific information can come to light that changes our understanding of potential effects from pesticides.

Thank you.