16
Oct
EPA Rejects Petition Seeking Review of Complete Ingredients in Pesticide Products
(Beyond Pesticides, October 16, 2023) After six years, the Environmental Protection Agency (EPA) finally responded to a citizen petition requesting that the agency evaluate complete formulations of pesticide products, not just the ingredients the manufacturer claims attack the target pest (so-called “active†ingredients). EPA’s response: No. Nowhere in EPA’s denial of the need for a more robust toxicological analysis is the problem more evident than in its refusal to require analyses of the so-called “inert ingredients†or “adjuvants†included in various formulations of pesticide products. The citizen petition [see more background] was followed by a lawsuit for the same purpose in 2022.
Inerts and formulants are substances that enhance the distribution or adhesion of the active ingredient; adjuvants enhance the effectiveness of the active ingredient. These terms suggest that those chemicals have no effect on anything in the area where the pesticide is applied—a wildly inaccurate implication. At least as early as 1987, EPA had recognized that some inerts and adjuvants were “of toxicological concern,†yet it still requires very few toxicological tests of whole-formula pesticides or their purportedly inactive components.
EPA responded to the petition as follows: “[T]he Agency appropriately assesses, as part of its review, the impacts to human health and the environment, including potential impacts from pesticide products and tank mixes, and why the additional testing that the petition sought would not in general provide a better picture of the risks of a pesticide product. As a result, EPA is denying the request to amend the regulatory testing requirements.†The agency, in its announcement, cites a full response but the links provided do not disclose it.
Despite EPA’s description of the adequacy of its pesticide product reviews, analysts have pointed to examples of the deficient full product formulation analyses, exemplifying the failure to protect pollinators and the inadequacy of the  agency’s review of products containing the glyphosate weed killer product Roundup. Glyphosate—the globally distributed herbicide widely used around homes, gardens, schoolyards, and throughout communities—has been declared “a probable human carcinogen†by the International Agency for Research on Cancer, while declared exactly the opposite—“unlikely to be a human carcinogenâ€â€”by EPA. Glyphosate entered the market in 1974, when EPA was in its infancy. Its use exploded over the next 40 years and is now marketed in hundreds of formulations including many adjuvants and inert ingredients. Toxicologists assumed that, because glyphosate affects plants by a metabolic pathway not found in animals, animals would be perfectly safe when exposed to it. Subsequent research showed that this is not true.
At no time have EPA or the original manufacturer of glyphosate, Monsanto (now Bayer AG) found it necessary to investigate the effects of the “inerts,†or the combined effects of “active ingredients†and inerts used in glyphosate products such as Roundup. The 2017 CFS petition  requested EPA to “require testing and data on the actual pesticide formulations and mixtures in regulating pesticide use, and to consider the effects of actual pesticide formulations and mixtures on endangered and threatened species.†The petition used glyphosate and its additives as a case study. Again, EPA’s most recent announcement says it will do nothing in response to the petition, and presumably the 2022 lawsuit.
In a comment supporting the petition, Beyond Pesticides pointed out that because of its refusal to require appropriate testing and consider the real world in which pesticides act, “EPA may have no knowledge of the effect of pesticide products, as commonly applied, on chronic toxicity, mutagenicity, developmental toxicity and reproduction, or subchronic oral toxicity, inhalation toxicity, and neurotoxicity, when registering pesticide products.â€
The 2022, the CFS suit against EPA, joined by Californians for Pesticide Reform (CPR), Center for Environmental Health (CEH), and Pesticide Action Network of North America (PANNA), states, “Over half of so-called inert ingredients approved by the EPA for use in pesticide formulations are considered hazardous air and water pollutants of at least moderate risk. In fact, inert ingredients can be more toxic than active ingredients to non-target species.†Their complaint cites EPA’s statement that “inert†does not mean non-toxic.â€
In parallel with pressing for inclusion of whole formulations and inerts in its evaluation of pesticides, the lawsuit also alleges that EPA has failed in its obligation to protect endangered species from pesticides. When EPA issued an interim decision in 2020, Beyond Pesticides, Rural Coalition, Organizacion en California de Lideres Campesinas, Farmworker Association of Florida, and CFS petitioned the Ninth Circuit Court of Appeals for review on the grounds that EPA’s conclusion that glyphosate posed no human health risk was premature. At the time, Beyond Pesticides executive director Jay Feldman noted that “EPA failed to consider if Roundup disrupts the balance of nature and ecosystem health, critical to the survival of a vast number of organisms on which life depends–from beneficial insects, such as parasitoid wasps, lacewings, ladybugs, and endangered bumblebees, monarch butterflies, to fish, small mammals, and amphibians.â€
A separate petition by the Natural Resources Defense Council attacked EPA’s failure to abide by the Endangered Species Act (ESA). Numerous industry groups representing growers of cotton, corn sorghum, and sugar beets, the American Farm Bureau and golf course managers filed as intervenors. Finally, in June 2022, a three-judge panel of Ninth Circuit judges came down on the side of all the petitioners. It said EPA’s reasoning as to glyphosate and cancer was “inconsistent,†and that the EPA had violated ESA. The court ordered EPA to complete its registration review, including revisiting the cancer and ESA issues, by October 2022.
From the Ninth Circuit opinion: “According to EPA’s conclusion in the Cancer Paper, glyphosate is ‘not likely’ to be carcinogenic to humans because animal-tumor and genotoxicity studies showed no reason for concern. But this conclusion is in tension with parts of the agency’s own analysis and with the guidelines it purports to follow†(emphasis added). The court saw what any reasonable person can see: That EPA suffers from severe cognitive dissonance. There is no reasonable explanation for this internal conflict but political interference, which has been documented to occur in glyphosate registration as early as 1976, and repeatedly since. Beyond Pesticides has covered this governmental and industry malfeasance here, here, and here.
EPA also issued a biological evaluation of glyphosate’s effects on endangered species in 2021. This document admits outright that 93 percent of all endangered animal and plant species and 96 percent of their critical habitats are likely to be adversely affected by glyphosate exposure. For each category of species—mammals, plants, fish, invertebrates, etc.–a large majority of species met the “likely to adversely affect†threshold. EPA listed no species in any category that would likely experience zero effect.
Given EPA’s failures, there is insufficient data about nontarget effects and the actions of inert and adjuvant ingredients in pesticides. Two California scientists—Caroline Cox, formerly with the Center for Environmental Health, and Michael Zeiss, formerly with the California Department of Pesticide Regulation—conducted a case study in 2022 on an adjuvant called a-(p-nonylphenyl)-x-hydroxypoly(oxyethylene) (APNOHO). They found that the chemical is included in more than 150 adjuvant products in California and identified as inert in a further 650 pesticides nationally. EPA does not register inerts, but California classes them as pesticides and identifies APNOHO as the most-used pesticide in the state. The California study found that the number of acres treated with APNOHO in California doubled in 20 years, reaching over 10 million acres in 2020. The authors also observed that EPA considers inerts “confidential business information,†which makes it difficult for the public and researchers to learn about them.
The European Union has identified APNOHO as an endocrine disrupter (ED), but EPA has not formally evaluated its ED properties. The California researchers found studies back to 1993 clearly demonstrating APNOHO’s ED activity, and a 2000 lab study showed APNOHO causing estrogen-responsive breast cancer cells to proliferate. It may be a more potent ED than methoxychlor and vinclozolin, two notorious active pesticide ingredients. Environmental studies of APNOHO have demonstrated APNOHO’s severe toxicity to fish and aquatic invertebrates.
This case study of one of hundreds of adjuvants and inerts illustrates the urgency of EPA’s failure to require their testing, yet there is no evidence EPA has seen the light. To add insult to a growing mountain of insults, EPA issued an outrageous letter to CFS on September 28. Despite all the intervening court rulings, its own misgivings about inerts and adjuvants, and its own biological evaluation under the ESA, EPA denied CFS et al’s 2017 petition to revise the agency’s testing protocols to include the chemicals that are mixed with the technical-grade active ingredients. EPA claims “the additional testing that the petition seeks would not in general provide a better picture of the risks of a pesticide product…the acute and chronic toxicity data EPA currently receives are sufficient for evaluating the potential risk from the registered use of a pesticide product.†EPA proposes some ineffectual steps, such as requiring more reporting of adverse incidents, rather than reaching for the root of the problem.
Conservation and environmental groups have not given up. In a press release, CFS lead attorney on the case Sylvia Wu promises that CFS would be “rigorously exploring and pursuing all next steps to protect communities and the environment.” EPA apparently sees no limit to its refusal to obey U.S. laws, which means more rounds of litigation while the agency delays.
“This failure on EPA’s part is yet another compelling reason to shift society away from dependency on toxic pesticides and to organic land management,†says Mr. Feldman.
All unattributed positions and opinions in this piece are those of Beyond Pesticides.
Source: 2017 Citizen Petition; 2022-10-12-CFS complaint; EPA-Petition-Denial-CFS-9.28.23; Regulations.gov
