{"id":33779,"date":"2023-10-27T00:01:27","date_gmt":"2023-10-27T04:01:27","guid":{"rendered":"https:\/\/beyondpesticides.org\/dailynewsblog\/?p=33779"},"modified":"2023-10-27T13:05:58","modified_gmt":"2023-10-27T17:05:58","slug":"epa-to-allow-genetically-based-pesticides-incomplete-testing-and-documented-adverse-effects","status":"publish","type":"post","link":"https:\/\/beyondpesticides.org\/dailynewsblog\/2023\/10\/epa-to-allow-genetically-based-pesticides-incomplete-testing-and-documented-adverse-effects\/","title":{"rendered":"EPA To Allow Genetically-Based Pesticides, Incomplete Testing, and Documented Adverse Effects"},"content":{"rendered":"\r\n

(Beyond Pesticides<\/em>, October 27, 2023) In a typical move, EPA proposes to greenlight a type of genetic engineering to solve a problem created by the industrial paradigm for pest control, i.e. vast acreages of monoculture treated with millions of tons of toxic pesticides leading to rapid resistance among crop pests. In this case EPA wants to approve using a nucleic acid\u2014double-stranded RNA (dsRNA)–called \u201cinterfering RNA,\u201d or RNAi\u2014to silence a gene crucial to the survival of the Colorado Potato Beetle (CPB), the scourge of potato farmers around the world. But EPA has skipped over important steps in its decision-making process and rushed to judgment.<\/p>\r\n

Like chemical pesticides, genetically-based pesticides are regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). In 2020, Massachusetts-based GreenLight Biosciences applied for registration of its RNAi active ingredient, Ledprona, and its end-use product, Calantha. The company executive<\/a> heading the effort is an alumnus of Monsanto and several other major chemical companies. Last May EPA granted GreenLight an Experimental Use Permit (EUP) authorizing field studies in states that produce tons of potatoes. A mere five months later, EPA announced<\/a> its decision to approve the registration based almost entirely on incomplete EUP data and giving the public very little time to comment.<\/p>\r\n

Formally titled \u201cColorado Potato Beetle (CPB)-specific recombinant double-stranded interfering Oligonucleotide GS2 Leptinotarsa decemlineata,<\/em>\u201d Ledprona disrupts an RNA process inside cells to block expression of a particular CPB gene. This prevents the gene from specifying an important protein. When a CPB ingests Ledprona on a potato leaf, the RNAi nucleotide spreads into the cells of the beetle\u2019s gut. The cells die, which shortly kills the beetle.<\/p>\r\n

Unfortunately, dsRNA molecules may wander from their intended targets. Inside a cell, the long dsRNA strand gets clipped into small pieces called siRNAs (\u201csmall interfering RNAs\u201d), whose configuration may also align with many other sections of a genome and affect nontarget genes, with entirely different effects. One experiment with interfering RNA found<\/a> complete matches in 17 percent of off-target sequences. Neither EPA nor Greenlight has addressed this risk.<\/p>\r\n

According to EPA\u2019s Environmental Risk Assessment (ERA), Greenlight intends Calantha to be applied in ground spray, aerial spray (via airplane) and in irrigation water\u2014in other words, very broadly, and in a manner that will inevitably entail some spray drift.<\/p>\r\n

The Center for Food Safety (CFS) prepared a blistering comment to EPA noting the agency\u2019s extreme disregard for both known biological processes and the unknowns of losing a novel piece of cellular machinery into the wild. According to the CFS, the EUP field trials granted to Greenlight remain incomplete and will not expire until April 30, 2025, yet EPA admits that its approval of Ledprona and Calantha relies solely on data Greenlight submitted with its application for the EUP–whose data requirements are considerably lower than those for new use approvals. FIFRA requires, for example, data on toxicity to fish, birds, and plants. GreenLight has not provided that data so far.<\/p>\r\n

EPA assumes that only organisms that resemble the CPB might be susceptible to Ledprona\u2019s interference with their cellular machinery, yet dismisses even that possibility. The agency\u2019s ERA states that \u201cthere is a reasonable expectation of no discernible effects to occur to any non-coleopteran nontarget organisms exposed to Ledprona…EPA analysis also examined the 19 federally listed threatened and endangered (\u2018listed\u2019) coleopteran species and determined that no exposure is expected for 15 of the 19 federally listed threatened and endangered (\u2018listed\u2019) coleopteran species from a section 3 registration of Calantha containing Ledprona.\u201d (The CPB belongs to the order Coleoptera<\/a>, along with 400,000 other beetle species known to science. Many coleopterans provide beneficial services.)<\/p>\r\n

Additionally, EPA says, \u201cPhysiological barriers are present within vertebrate species that prevent the dsRNA such as Ledprona from reaching and penetrating the gut in vertebrate species.\u201d Given the unpredictable alignments of the small interfering RNAs in a genome, this too is an iffy assumption. The CFS comment notes that, although EPA has not provided any information to the public about Ledprona\u2019s nucleotide length, that data is an important factor in assessing the product\u2019s potential toxicity. EPA has designated the dsRNA in Ledprona as \u201cnon-coding,\u201d which it takes to mean that it would not function in a human body, but, in fact, nobody knows whether or how many such \u201clong, non-coding RNAs\u201d function in many species. What is<\/em> known, according to CFS, is that human innate immune systems respond to such sequences, which often come from viruses or from the body\u2019s own damaged cells, with inflammation.<\/p>\r\n

We can expect more pesticide products to be based on genetic processes such as RNAi\u2019s regulation of gene expression as farmers and chemical companies get more desperate with each passing report of pests\u2019 ability to evade pesticides. It is unsurprising that the CPB is an early target because it is notorious<\/a> for its rapid development of resistance. Currently it is resistant to more than 50 pesticides.<\/p>\r\n

In the long run CPB will win. It is already ahead. In 2021, a research team, three of whom are employed by Monsanto, found<\/a> that CPB \u201ccan develop high levels of resistance against insecticidal dsRNA\u201d when the dsRNA is applied to leaves. The study also found that the dsRNA affected more than one gene. Various analyses of CPB\u2019s response to a range of doses led the scientists to conclude that, after a few generations, resistance to dsRNA reached 11,100 times that of the founding generation of beetles. The researchers attributed CPB\u2019s virtuosic ability to resist pesticides partly to the beetle\u2019s highly flexible and transposable genetic elements. This indicates that creating precise and effective products using genetics is fraught with risks. A plain hydrocarbon molecule is understood vastly better than the interplay of the trillions of genes in the world.<\/p>\r\n

Pesticide resistance was first noted<\/a> in 1914, but the industry still fails to recognize that it cannot bet against the house. To cope with the inevitable triumph of natural selection<\/a>, pesticide manufacturers are promoting the use of dsRNA products in combination with traditional pesticides, with the idea that their mechanisms of action will alternate and prevent pests from adapting. Combining pesticides with RNA interference can be framed<\/a> as part of \u201cintegrated pest management,\u201d although as a 2018 review<\/a> in Science<\/em> noted, the notion that \u201csuch combinations will slow [the development of] resistance is theoretically controversial and lacks empirical support.\u201d<\/p>\r\n

Beyond Pesticides chronicled<\/a> in 2019 the promotion of interfering dsRNA technologies by pesticide companies despite the recognition that their effects on nontarget organisms cannot be predicted.<\/p>\r\n

\u201cWith the allowance of gene-manipulating RNAi pesticides, EPA is repeating a pattern of allowing uncertainty that has historically resulted in serious unexpected and uncontrolled hazards, despite the availability of organic practices and products that are currently available,\u201d said Beyond Pesticides\u2019 executive director, Jay Feldman. Mr. Feldman continued: \u201cThe agency has failed to fully evaluate the fate of genetic material and its degradation products on nontarget species and the likely potential for indiscriminate poisoning. We are calling for a moratorium on RNAi pesticides until these questions can be fully answered.\u201d<\/p>\r\n

The deadline for public comment on the registration of Ledprona and Calantha has been extended<\/a> to October 30. Visit here<\/a> for information about submitting comments and suggested sample wording.<\/p>\r\n

An expert at another federal agency once observed<\/a> that it is not a good idea to rely on \u201ca conclusion drawn from a consensus\u201d rather than from empirical evidence when making important decisions. In this case, EPA has done exactly that, mistaking suppositions for facts. EPA\u2019s decision rests on a foundation of uncertain assumptions, many of which are implicit in EPA\u2019s evaluation rather than explicitly enumerated, and whose reliability EPA did not examine.<\/p>\r\n

>>Click here to Take Action and tell EPA not to register genetically engineered pesticides without complete data!<\/a> Please take action by Monday, October 30, 2023 at 11:59 PM Eastern.<\/em><\/strong><\/p>\r\n

All unattributed positions and opinions in this piece are those of Beyond Pesticides.<\/em>\u00a0<\/p>\r\n

Sources:
\r\nEPA Opens Public Comment Period on Proposal to Register Novel Pesticide Technology for Potato Crops
\r\nhttps:\/\/www.epa.gov\/pesticides\/epa-opens-public-comment-period-proposal-register-novel-pesticide-technology-potato<\/a><\/p>\r\n

Environmental Risk Assessment for a FIFRA Section 3 Registration of the New Product GS2 Formulation (Calantha) Containing Ledprona
\r\nhttps:\/\/www.regulations.gov\/document\/EPA-HQ-OPP-2021-0271-0006<\/a><\/p>\r\n

Human Health Risk Assessment, Review of Product Characterization and Manufacturing Process for the New end-use product, CalanthaHuman Health Risk Assessment, Review of Product Characterization and Manufacturing Process for the New end-use product, Calantha
\r\nhttps:\/\/www.regulations.gov\/document\/EPA-HQ-OPP-2021-0271-0005<\/a><\/p>\r\n","protected":false},"excerpt":{"rendered":"

(Beyond Pesticides, October 27, 2023) In a typical move, EPA proposes to greenlight a type of genetic engineering to solve a problem created by the industrial paradigm for pest control, i.e. vast acreages of monoculture treated with millions of tons of toxic pesticides leading to rapid resistance among crop pests. In this case EPA wants to approve using a nucleic acid\u2014double-stranded RNA (dsRNA)–called \u201cinterfering RNA,\u201d or RNAi\u2014to silence a gene crucial to the survival of the Colorado Potato Beetle (CPB), the scourge of potato farmers around the world. But EPA has skipped over important steps in its decision-making process and rushed to judgment. Like chemical pesticides, genetically-based pesticides are regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). In 2020, Massachusetts-based GreenLight Biosciences applied for registration of its RNAi active ingredient, Ledprona, and its end-use product, Calantha. The company executive heading the effort is an alumnus of Monsanto and several other major chemical companies. Last May EPA granted GreenLight an Experimental Use Permit (EUP) authorizing field studies in states that produce tons of potatoes. A mere five months later, EPA announced its decision to approve the registration based almost entirely on incomplete EUP data and giving the public very […]<\/p>\n","protected":false},"author":2,"featured_media":33822,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[249,354,5,276,1,13],"tags":[],"class_list":["post-33779","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-agriculture","category-environmental-protection-agency-epa","category-genetic-engineering","category-take-action","category-uncategorized","category-wildlifeenvironment"],"yoast_head":"\nEPA To Allow Genetically-Based Pesticides, Incomplete Testing, and Documented Adverse Effects - Beyond Pesticides Daily News Blog<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/beyondpesticides.org\/dailynewsblog\/2023\/10\/epa-to-allow-genetically-based-pesticides-incomplete-testing-and-documented-adverse-effects\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EPA To Allow Genetically-Based Pesticides, Incomplete Testing, and Documented Adverse Effects - Beyond Pesticides Daily News Blog\" \/>\n<meta property=\"og:description\" content=\"(Beyond Pesticides, October 27, 2023) In a typical move, EPA proposes to greenlight a type of genetic engineering to solve a problem created by the industrial paradigm for pest control, i.e. vast acreages of monoculture treated with millions of tons of toxic pesticides leading to rapid resistance among crop pests. 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