{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,3]],"date-time":"2026-09-03T13:52:36Z","timestamp":1788443556042,"version":"build-2803163510"},"reference-count":15,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,8,22]],"date-time":"2026-08-22T00:00:00Z","timestamp":1787356800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,8,22]],"date-time":"2026-08-22T00:00:00Z","timestamp":1787356800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/501100010771","name":"Bundesanstalt f\u00fcr Landwirtschaft und Ern\u00e4hrung","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100010771","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["scijournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pest Management Science"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    RNA interference (RNAi), a naturally occurring gene\u2010silencing mechanism, has emerged as a promising platform for developing innovative, non\u2010genetically modified (GM) plant protection products. In the context of climate change, biodiversity loss, and growing resistance to traditional pesticides, the need for highly specific, environmentally compatible alternatives for sustainable pest management is increasing. RNAi\u2010based sprays are a novel approach in which double\u2010stranded RNA (dsRNA) molecules silence essential genes in target pests without acting like toxic conventional compounds. A significant advancement in this technology occurred with the 2023 approval of Calantha\u2122 (Ledprona) in the USA, marking the first authorization of an RNAi\u2010based biopesticide for agricultural use. Ledprona targets the Colorado potato beetle by silencing specific genes following foliar dsRNA application. Here, we summarize the mechanism of action, efficacy, environmental behavior, and safety assessment of Ledprona as evaluated by the US Environmental Protection Agency. In addition, we discuss the broader regulatory implications of this approval and highlight key challenges and opportunities for assessing and implementing RNAi\u2010based plant protection products within the European Union's regulatory framework. \u00a9 2026 The Author(s).\n                    <jats:italic>Pest Management Science<\/jats:italic>\n                    published by John Wiley &amp; Sons Ltd on behalf of Society of Chemical Industry.\n                  <\/jats:p>","DOI":"10.1002\/ps.71219","type":"journal-article","created":{"date-parts":[[2026,8,22]],"date-time":"2026-08-22T19:04:06Z","timestamp":1787425446000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["The first\n                    <scp>RNAi<\/scp>\n                    \u2010based biopesticide approved in the United States: regulatory implications for the European Union \u2013 the case of Ledprona (Calantha\u2122)"],"prefix":"10.1002","author":[{"ORCID":"https:\/\/orcid.org\/0009-0004-4763-1800","authenticated-orcid":false,"given":"Aline","family":"Koch","sequence":"first","affiliation":[{"name":"Institute of Plant Sciences, Plant RNA Transport University of Regensburg  Regensburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2251-593X","authenticated-orcid":false,"given":"Gabi","family":"Krczal","sequence":"additional","affiliation":[{"name":"RLP AgroScience GmbH  Neustadt an der Weinstra\u00dfe Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,8,22]]},"reference":[{"key":"e_1_2_16_2_1","doi-asserted-by":"publisher","DOI":"10.1105\/tpc.2.4.279"},{"key":"e_1_2_16_3_1","doi-asserted-by":"publisher","DOI":"10.1105\/tpc.2.4.291"},{"key":"e_1_2_16_4_1","doi-asserted-by":"crossref","first-page":"806","DOI":"10.1038\/35888","article-title":"Potent and specific genetic interference by double\u2010stranded RNA in Caenorhabditis elegans","volume":"391","author":"Fire A","year":"1998","journal-title":"Nature"},{"key":"e_1_2_16_5_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41565-019-0591-y"},{"key":"e_1_2_16_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00003-024-01507-7"},{"key":"e_1_2_16_7_1","doi-asserted-by":"publisher","DOI":"10.5073\/JFK.2022.03-04.05"},{"key":"e_1_2_16_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/nph.17364"},{"key":"e_1_2_16_9_1","doi-asserted-by":"publisher","DOI":"10.3389\/fpls.2021.755203"},{"key":"e_1_2_16_10_1","doi-asserted-by":"publisher","DOI":"10.1038\/nbt1359"},{"key":"e_1_2_16_11_1","first-page":"23","article-title":"RNA agents against the Colorado potato beetle are promising","volume":"4","author":"Koch A","year":"2023","journal-title":"Kartoffelbau"},{"key":"e_1_2_16_12_1","doi-asserted-by":"publisher","DOI":"10.3389\/fpls.2021.728652"},{"key":"e_1_2_16_13_1","unstructured":"U.S. Environmental Protection Agency Final Human Health Risk Assessment Review of Product Characterisation and Manufacturing Process for the New End\u2010Use Product Calantha\u2122 Containing 0.8% of the New Active Ingredient \u2018Ledprona\u2019 dsRNA for Use on all Raw Agricultural Products and Food Products and Associated Petition to Establish a Permanent Tolerance. Memorandum No. EPA\u2010HQ\u2010OPP\u20102021\u20100271\u20100005. United States Environmental Protection Agency(2023)."},{"key":"e_1_2_16_14_1","unstructured":"Federal Insecticide Fungicide and Rodenticide Act (FIFRA).973:92\u2013516(1972)."},{"key":"e_1_2_16_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/etc.3585"},{"key":"e_1_2_16_16_1","unstructured":"Federal Food Drug and Cosmetic Act (FD&C Act) 21:301\u2013392(2018)."}],"container-title":["Pest Management Science"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/scijournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ps.71219","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/scijournals.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/ps.71219","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/scijournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ps.71219","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,22]],"date-time":"2026-08-22T19:04:08Z","timestamp":1787425448000},"score":1,"resource":{"primary":{"URL":"https:\/\/scijournals.onlinelibrary.wiley.com\/doi\/10.1002\/ps.71219"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8,22]]},"references-count":15,"alternative-id":["10.1002\/ps.71219"],"URL":"https:\/\/doi.org\/10.1002\/ps.71219","archive":["Portico"],"relation":{},"ISSN":["1526-498X","1526-4998"],"issn-type":[{"value":"1526-498X","type":"print"},{"value":"1526-4998","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8,22]]},"assertion":[{"value":"2026-03-14","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-08-05","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-08-22","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"ps.71219"}}