View source for Clothianidin

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'''Clothianidin''' is an [[insecticide]] developed by [[Takeda Chemical Industries]] and [[Bayer AG]]. Similar to [[thiamethoxam]] and [[imidacloprid]], it is a [[neonicotinoid]]. Neonicotinoids are a class of insecticides that are chemically similar to [[Nicotine#As an insecticide|nicotine]], which has been used as a pesticide since the late 1700s. Clothianidin and other neonicotinoids act on the [[central nervous system]] of insects as an agonist of [[nAChR]], the same receptor as [[acetylcholine]], the neurotransmitter that stimulates and activating post-synaptic acetylcholine receptors but not inhibiting [[AChE]]. Clothianidin and other neonicotinoids were developed to last longer than nicotine, which is more toxic and which breaks down too quickly in the environment.

A 2018 review by the [[European Food Safety Authority]] (EFSA) concluded that most uses of neonicotinoid pesticides such as clothianidin represent a risk to wild bees and honeybees.<ref>{{Cite web |date=2018-02-28 |title=Neonicotinoids: risks to bees confirmed {{!}} EFSA |url=https://www.efsa.europa.eu/en/press/news/180228 |access-date=2023-06-23 |website=www.efsa.europa.eu |language=en}}</ref><ref name="EFSA2">European Food Safety Authority (16 January 2013) [https://efsa.onlinelibrary.wiley.com/doi/abs/10.2903/j.efsa.2013.3066 "Conclusion on the peer review of the pesticide risk assessment for bees for the active substance clothianidin"] ''EFSA Journal'' '''11'''(1):3066.</ref> In 2022 the [[United States Environmental Protection Agency]] (EPA) concluded that clothianidin is likely to adversely affect 67 percent of federally listed endangered or threatened species and 56 percent of critical habitats.<ref>{{Cite web |last=US EPA |first=OCSPP |date=2022-06-16 |title=EPA Finalizes Biological Evaluations Assessing Potential Effects of Three Neonicotinoid Pesticides on Endangered Species |url=https://www.epa.gov/pesticides/epa-finalizes-biological-evaluations-assessing-potential-effects-three-neonicotinoid |access-date=2023-06-23 |website=www.epa.gov |language=en}}</ref> The pesticide has been banned for all outdoor use in the entire European Union since 2018, but has a conditional approval in the U.S. and other parts of the world, where it is widely used.<ref>{{Cite news |last=Carrington |first=Damian |last2= |first2= |date=2018-04-27 |title=EU agrees total ban on bee-harming pesticides |language=en-GB |work=The Guardian |url=https://www.theguardian.com/environment/2018/apr/27/eu-agrees-total-ban-on-bee-harming-pesticides |access-date=2023-06-23 |issn=0261-3077}}</ref><ref>{{Cite news |last=Milman |first=Oliver |date=2022-03-08 |title=Fears for bees as US set to extend use of toxic pesticides that paralyse insects |language=en-GB |work=The Guardian |url=https://www.theguardian.com/environment/2022/mar/08/us-epa-toxic-pesticides-paralyse-bees-insects |access-date=2023-06-23 |issn=0261-3077}}</ref>

Clothianidin is an alternative to [[organophosphate]], [[carbamate]], and [[pyrethroid]] pesticides. It poses lower risks to mammals, including humans, when compared to organophosphates and carbamates. It has helped prevent insect pests from building up resistance to organophosphate and pyrethroid pesticides.<ref name="USEPA19">{{cite web |title=USEPA Clothianidin fact sheet |url=http://www.epa.gov/opp00001/chem_search/reg_actions/registration/fs_PC-044309_30-May-03.pdf |access-date=14 October 2013 |publisher=U.S. Environmental Protection Agency}}</ref><ref name="AU12">{{cite web |title=Australian evaluation of the new active CLOTHIANIDIN |url=http://www.apvma.gov.au/registration/assessment/docs/prs_clothianidin.pdf |url-status=dead |archive-url=https://web.archive.org/web/20110930163143/http://www.apvma.gov.au/registration/assessment/docs/prs_clothianidin.pdf |archive-date=30 September 2011 |access-date=15 August 2011 |publisher=Australian Pesticides and Veterinary Medicines Authority}}</ref><ref name="UK12">{{cite web |title=Background Information On Use Of Neonicotinoid Pesticides And Their Effects On Bees |url=http://www.pesticides.gov.uk/environment.asp?id=2989 |access-date=16 August 2011 |publisher=U.K. Chemicals Regulation Directorate of the Health and Safety Executive}}</ref>

== Authorized uses ==

Clothianidin is authorized for spray, dust, soil drench (for uptake via plant roots), [[tree injection|injectable]] liquid (into tree limbs and trunks, sugar cane stalks etc.), and [[seed treatment]] uses, in which clothianidin coats seeds that take up the pesticide via the roots as the plant grows. The chemical may be used to protect plants against a wide variety of agricultural pests in many countries, of which the following are mentioned in citable English-language sources: Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, Estonia, France, Finland, Germany, Greece, Hungary, Italy, Ireland, Japan, Korea, Lithuania, Netherlands, New Zealand, Poland, Portugal, Serbia, Slovakia, Slovenia, Spain, UK, and the United States. Seed treatment uses of clothianidin, corn in particular, have been revoked or suspended in Germany, Italy and Slovenia. The suspensions are reflective of E.U. pesticide law and are generally associated with acute poisoning of bees from pesticide dust being blown off of treated seeds, especially corn, and onto nearby farms where bees were performing pollinator services.<ref name="AU1">{{cite web |title=Australian evaluation of the new active CLOTHIANIDIN |url=http://www.apvma.gov.au/registration/assessment/docs/prs_clothianidin.pdf |url-status=dead |archive-url=https://web.archive.org/web/20110930163143/http://www.apvma.gov.au/registration/assessment/docs/prs_clothianidin.pdf |archive-date=30 September 2011 |access-date=15 August 2011 |publisher=Australian Pesticides and Veterinary Medicines Authority}}</ref><ref name="IE1">{{cite web|title=Pesticides 2011|url=http://www.pcs.agriculture.gov.ie/Docs/Pesticides2011.pdf|publisher=Ireland's Pesticide Registration & Control Division Department of Agriculture, Fisheries and Food|access-date=12 August 2011|archive-url=https://web.archive.org/web/20110721124710/http://www.pcs.agriculture.gov.ie/Docs/Pesticides2011.pdf|archive-date=21 July 2011|url-status=dead}}</ref><ref name="USEPA2">{{cite web |title=Clothianidin Status web page |url=http://www.epa.gov/opp00001/about/intheworks/clothianidin-registration-status.html |publisher=USEPA|access-date=12 August 2011}}</ref><ref name="AU2">{{cite web |title=Clothianidin registration announcement |url=http://apvma.gov.au/node/12156 |publisher=Australian Pesticides and Veterinary Medicines Authority|access-date=5 April 2015|date=2014-09-30 }}</ref><ref name="CN1">{{cite web|title=Registration Decision RD2013-14, Clutch 50 WDG, Arena 50 WDG and Clothianidin Insecticides|url=http://www.hc-sc.gc.ca/cps-spc/pubs/pest/_decisions/rd2013-14/index-eng.php|publisher=Health Canada, Pest Management Regulatory Agency|access-date=14 October 2013|archive-url=https://web.archive.org/web/20131014211253/http://www.hc-sc.gc.ca/cps-spc/pubs/pest/_decisions/rd2013-14/index-eng.php|archive-date=14 October 2013|url-status=dead}}</ref><ref name="UK2">{{cite web|title=Mode of Action Classification Table for Uk Approved Insecticide Active Substances|url=http://www.pesticides.gov.uk/uploadedfiles/Web_Assets/RAGs/IRAG_UK_MOA_vers_3_June_2009.pdf|publisher=Insecticide Resistance Action Group, U.K.|access-date=16 August 2011}}</ref><ref name="UK3">{{cite web|title=Background Information On Use Of Neonicotinoid Pesticides And Their Effects On Bees, see Action in other Member States|url=http://www.pesticides.gov.uk/environment.asp?id=2989|publisher=U.K. Chemicals Regulation Directorate of the Health and Safety Executive|access-date=16 August 2011}}</ref>

Clothianidin was prequalified for [[indoor residual spraying]] by the [[World Health Organization]] in 2017.<ref>{{cite web |title=WHO Prequalification Vector Control SumiShield 50WG |url=https://www.who.int/pq-vector-control/prequalified-lists/sumishield50wg/en/ |archive-url=https://web.archive.org/web/20180220162924/http://www.who.int/pq-vector-control/prequalified-lists/sumishield50wg/en/ |url-status=dead |archive-date=February 20, 2018 |publisher=WHO|access-date=22 April 2021}}</ref>

== Background ==

Although nicotine has been used as a pesticide for over 200 years it degraded too rapidly in the environment and lacked the selectivity to be very useful in large-scale agricultural situations. However, in order to address this problem, the neonicotinoids ([[chloronicotinyl]] insecticides) were developed as a substitute of nicotine. Clothianidin is an alternative to [[organophosphate]], [[carbamate]], and [[pyrethroid]] pesticides. It poses lower risks to mammals, including humans, when compared to organophosphates and carbamates. It also plays a key role helping to prevent the buildup in insect pests of resistance to organophosphate and pyrethroid pesticides, which is a growing problem in parts of Europe.<ref name="USEPA1">{{cite web |title=USEPA Clothianidin fact sheet |url=http://www.epa.gov/opp00001/chem_search/reg_actions/registration/fs_PC-044309_30-May-03.pdf |access-date=14 October 2013 |publisher=U.S. Environmental Protection Agency}}</ref><ref name="AU1"/><ref name="UK1">{{cite web |title=Background Information On Use Of Neonicotinoid Pesticides And Their Effects On Bees |url=http://www.pesticides.gov.uk/environment.asp?id=2989 |access-date=16 August 2011 |publisher=U.K. Chemicals Regulation Directorate of the Health and Safety Executive}}</ref>

Clothianidin was first given registration for use as a pesticide by the Japan Plant Protection Association in 2001.<ref>[https://www.sumitomo-chem.co.jp/english/rd/report/files/docs/20060202_h6t.pdf Discovery and Development of aNovel Insecticide “Clothianidin”] translated  from  R&D  Report,  “SUMITOMO  KAGAKU”,  vol.  2006-II, ''sumitomo-chem.co.jp'', accessed 11 June 2019</ref> Followed by conditional registration by the United States Environmental Protection Agency in 2003, pending the completion of additional study of its safety to be done by December 2004.  Bayer did not complete the study on time and asked for an extension.  The date was postponed to May 2005 and  they also granted Bayer the permission it had sought to conduct its study on [[canola]] in Canada, instead of on [[maize]] in the United States.  The study was not completed until 2007.  In a November 2007 memo EPA scientists declared the study “scientifically sound,” adding that it, “satisfies the guideline requirements for a field toxicity test with [[honeybees]].”<ref name="USEPA1" /><ref>[http://grist.org/article/food-2010-12-10-leaked-documents-show-epa-allowed-bee-toxic-pesticide/ Leaked document shows EPA allowed bee-toxic pesticide despite own scientists’ red flags | Grist<!-- Bot generated title -->] 11 December 2010 ''grist.org'', accessed 11 June 2019</ref>

Clothianidin continued to be sold under a conditional registration, and in April 2010 it was granted an unconditional registration for use as a seed treatment for corn and canola. However, in response to concerns raised by [[bee keepers]], in November the EPA released a memorandum in which they stated that some of the studies submitted did not appear to be adequate and the unconditional registration was withdrawn.<ref name="USEPA4">{{cite web|title=USEPA Freedom of Information Act e-Reading Room for Clothianidin|url=http://www.epa.gov/pesticides/chemical/foia/cleared-reviews/reviews/044309/044309.htm|publisher=USEPA|access-date=15 August 2011}}</ref><ref name="USEPA17">{{cite web|title=Clothinidin Status: 2010 Reclassification of Clothianidin Field Study for Pollinators|url=http://www.epa.gov/opp00001/about/intheworks/clothianidin-registration-status.html#reclassification|publisher=USEPA|access-date=15 August 2011}}</ref>

In 2012, arguing that after more than 9 years the EPA continues to maintain the registration status for clothianidin despite the fact that the registrant has failed to supply satisfactory studies confirming its safety, an alliance of beekeepers and environmental groups filed a petition on March 21 asking the EPA to block the use of clothianidin in agricultural fields until they have conducted a review of the product. The petitioners state that they are aware that the EPA has moved up its registration review of clothianidin and other neonicotinoids in response to concerns about their impacts on [[pollinators]], however they note that this process is projected by the EPA to take six to eight years and is thus grossly insufficient to address the urgency of the threat to pollinators.<ref>[http://www.panna.org/sites/default/files/CFS-Clothianidin-Petition-3-20-12.pdf Emergency Citizen Petition to the United States Environmental Protection Agency] Jeff Anderson, Manley and Linda Bigalk and 25 other commercial beekeepers and honeyproducers, and four environmental and consumer organizations,represented by:Center for Food Safety ''panna.org'', accessed 11 June 2019</ref>

== Toxicity ==

Regulatory authorities describe the toxicological database for clothianidin as "extensive", and many studies have been reviewed to support registrations around the globe for this chemical. Laboratory and field testing revealed that clothianidin shows relatively low [[toxicity]] to many test species but is highly or very highly toxic to others.  Toxicity varies depending on whether the exposure occurs on a short-term (acute) or long-term (chronic) basis.<ref name="AU1" /><ref name="CN1" /><ref name="USEPA4"/><ref name="AU4">{{cite web|title=Advice Summary, Application for Registration of a Chemical Product|url=http://www.apvma.gov.au/advice_summaries/38709.pdf|publisher=Australian Pesticides and Veterinary Medicines Authority|access-date=15 August 2011|archive-url=https://web.archive.org/web/20110930163318/http://www.apvma.gov.au/advice_summaries/38709.pdf|archive-date=30 September 2011|url-status=dead}}</ref><ref name="AU5">{{cite web|title=Advice Summary, Application for Variation of a Registered Chemical Product|url=http://www.apvma.gov.au/advice_summaries/46234.rtf|publisher=Australian Pesticides and Veterinary Medicines Authority|access-date=15 August 2011|archive-url=https://web.archive.org/web/20110930163347/http://www.apvma.gov.au/advice_summaries/46234.rtf|archive-date=30 September 2011|url-status=dead}}</ref>

=== Bees and other insect pollinators ===
{{See also|Pesticide toxicity to bees}}

[[Honey bee]]s pollinate crops responsible for about a third of the human diet; about $224 billion worth of crops worldwide.<ref>Kinver, M. (27 September 2010) [https://www.bbc.co.uk/news/science-environment-11418033 "'Pollination crisis' hitting India's vegetable farmers"] ''BBC News''</ref> Beginning in 2006, beekeepers in the United States began to report unexplained losses of hives &mdash; 30 percent and upward &mdash; leading to a phenomenon called [[colony collapse disorder]] (CCD). The cause of CCD remains under debate, but scientific consensus is beginning to emerge suggesting that there is no one cause but rather a combination of factors including lack of foraging plants, infections, breeding, and pesticides—with none catastrophic on their own, but having a synergistic effect when occurring in combination.<ref name="BAKR12DBPO">Kay, J. (August 19, 2008) [http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2008/08/18/BAKR12DBPO.DTL "Lawsuit seeks EPA pesticide data"] ''San Francisco Chronicle''</ref><ref>MacKenzie, D. (16 February 2009) [https://www.newscientist.com/article/mg20126954.600-honeybees-under-attack-on-all-fronts.html "Honeybees under attack on all fronts"] ''New Scientist''</ref><ref>McGrath, M. (5 March 2009) [http://news.bbc.co.uk/1/hi/sci/tech/7925397.stm 'No proof' of bee killer theory] ''BBC News''</ref><ref name="Alaux2010">Alaux, C. ''et al.'' (2010) [http://panna.org/sites/default/files/Alaux_Neonics+Nosema.pdf "Interactions between ''Nosema'' microspores and a neonicotinoid weaken honeybees (Apis mellifera)"] ''Environmental Microbiology'' '''12'''(3):774–82</ref>

The [[Australian Pesticides and Veterinary Medicines Authority]] notes that clothianidin ranks "among the most highly acutely toxic insecticides to bees" through contact and oral exposure.<ref name="AUx">{{cite web |title=Australian evaluation of the new active CLOTHIANIDIN, p35 |url=http://www.apvma.gov.au/registration/assessment/docs/prs_clothianidin.pdf |url-status=dead |archive-url=https://web.archive.org/web/20110930163143/http://www.apvma.gov.au/registration/assessment/docs/prs_clothianidin.pdf |archive-date=30 September 2011 |access-date=15 August 2011 |publisher=Australian Pesticides and Veterinary Medicines Authority}}</ref> Since clothianidin is a systemic pesticide that is taken up by the plant, there is also potential for toxic chronic exposure resulting in long-term effects to bees and other pollinators from clothianidin residue in pollen and nectar. According to the [[Environmental Protection Agency]] (EPA), in addition to potential effects on worker bees, there are also concerns about lethal and/or sub-lethal effects in the larvae and reproductive effects in the queen from chronic exposure. However, in a 2012 statement the EPA reported that they are not aware of any data demonstrating that bee colonies are subject to elevated losses due to long-term exposure when clothianidin products are used at authorized rates.<ref name="USEPA5">{{cite web |title=Clothianidin Status web page, Risk Assessment and Risk Mitigation section |url=http://www.epa.gov/opp00001/about/intheworks/clothianidin-registration-status.html#risk |access-date=15 August 2011 |publisher=USEPA}}</ref><ref name="FR1">{{cite web |title=Weakening, collapse and mortality of bee colonies, last bullet on p. 49 |url=http://www.anses.fr/Documents/SANT-Ra-MortaliteAbeillesEN.pdf |url-status=dead |archive-url=https://web.archive.org/web/20131014181637/http://www.anses.fr/Documents/SANT-Ra-MortaliteAbeillesEN.pdf |archive-date=14 October 2013 |access-date=15 August 2011 |publisher=French Food Safety Agency}}</ref>

Honey bees and other pollinators are particularly sensitive to clothianidin, as evidenced by the results of laboratory and field toxicity testing and demonstrated in acute poisoning incidents in France and [[2008 German Beekill Incident|Germany in 2008]], and in Canada in 2010 and 2013{{citation needed|date=June 2017}} associated with the planting of corn seeds treated with clothianidin.<ref name="FR3">{{cite web |title=Weakening, collapse and mortality of bee colonies, p.88 |url=http://www.anses.fr/Documents/SANT-Ra-MortaliteAbeillesEN.pdf |url-status=dead |archive-url=https://web.archive.org/web/20131014181637/http://www.anses.fr/Documents/SANT-Ra-MortaliteAbeillesEN.pdf |archive-date=14 October 2013 |access-date=15 August 2011 |publisher=French Food Safety Agency}}</ref><ref name="CN5">{{cite web |title=Evaluation of Pesticide Incident Report 2010-3100 |url=http://www.hc-sc.gc.ca/cps-spc/pubs/pest/_decisions/erc2010-3100/index-eng.php |archive-url=https://web.archive.org/web/20130111023448/http://www.hc-sc.gc.ca/cps-spc/pubs/pest/_decisions/erc2010-3100/index-eng.php |archive-date=January 11, 2013 |access-date=October 14, 2013 |publisher=Health Canada, Pest Management Regulatory Agency}}</ref><ref name="CN6">{{cite web |title=Evaluation of Pesticide Incident Report 2010-3391 |url=http://www.hc-sc.gc.ca/cps-spc/pubs/pest/_decisions/erc2010-3391/index-eng.php |archive-url=https://web.archive.org/web/20130111023449/http://www.hc-sc.gc.ca/cps-spc/pubs/pest/_decisions/erc2010-3391/index-eng.php |archive-date=January 11, 2013 |access-date=October 14, 2013 |publisher=Health Canada, Pest Management Regulatory Agency}}</ref><ref name="CN7">{{cite web |title=Evaluation of Pesticide Incident Report 2010-4374 |url=http://www.hc-sc.gc.ca/cps-spc/pubs/pest/_decisions/erc2010-4374/index-eng.php |archive-url=https://web.archive.org/web/20130111023453/http://www.hc-sc.gc.ca/cps-spc/pubs/pest/_decisions/erc2010-4374/index-eng.php |archive-date=January 11, 2013 |access-date=October 14, 2013 |publisher=Health Canada, Pest Management Regulatory Agency}}</ref> To reduce the risk to pollinators from acute exposure to clothianidin sprays, label instructions prohibit the use of these products when crops or weeds are in bloom and pollinators are nearby, but in the U.S. label instructions do not require the use of a "sticker", a sticking agent meant to reduce dust from treated seeds during planting. However, according to the EPA, the use of sticking agents to reduce dust from treated seeds is standard practice in the U.S.<ref name="USEPA18">{{cite web |title=Pesticide News Story: EPA Acts to Protect Bees |url=http://www.epa.gov/oppfead1/cb/csb_page/updates/2008/bees-act.htm |url-status=dead |archive-url=https://web.archive.org/web/20110204045731/http://www.epa.gov/oppfead1/cb/csb_page/updates/2008/bees-act.htm |archive-date=4 February 2011 |access-date=15 August 2011 |publisher=USEPA}}</ref><ref name="BVL3">{{cite web |title=BVL 2.9.2009 Press Release |url=http://www.bvl.bund.de/EN/08_PresseInfothek_engl/01_Presse_und_Hintergrundinformationen/2009_02_09_pi_Maissaatgut_Mesurol_en.html?nn=1414138 |url-status=dead |archive-url=https://web.archive.org/web/20111005203622/http://www.bvl.bund.de/EN/08_PresseInfothek_engl/01_Presse_und_Hintergrundinformationen/2009_02_09_pi_Maissaatgut_Mesurol_en.html?nn=1414138 |archive-date=5 October 2011 |access-date=15 July 2011 |publisher=Federal Office of Consumer Protection and Food Safety}}</ref>

In a July [[2008 German Beekill Incident|2008 German beekill incident]], [[Germany|German]] beekeepers reported that 50 to 100 percent of their hives had been lost after [[pneumatic]] equipment used to plant corn seed blew clouds of pesticide dust into the air, which was then pushed by the wind onto neighboring [[canola]] fields in which managed bees were performing [[pollinator]] services. The accident was found to be the result of improper planting procedures and the weather. However, in 2009, Germany suspended authorization for the use of clothianidin on corn, citing unanswered questions that remained about potential exposure of bees and other pollinators to neonicotinoid pesticides.<ref name="BVL3" />
 
A 2011 Congressional Research Report describing some of the reasons why scientists believe honey bee colonies are being affected by CCD reported that the [[United States Department of Agriculture]] had concluded in 2009, "it now seems clear that no single factor alone is responsible for the malady." According to the research report, the neonicotinoids, which contain the active ingredient [[imidacloprid]], and similar other chemicals, such as clothianidin and [[thiamethoxam]], are being studied for a possible link to CCD. Honey bees are thought to possibly be affected by such chemicals, which are known to work their way through the plant up into the flowers and leave residues in the nectar and pollen that bees forage on. The scientists studying CCD have tested samples of pollen and have indicated findings of a broad range of substances, including insecticides, [[fungicides]], and [[herbicides]]. They note that the doses taken up by bees are not lethal, but they are concerned about possible chronic problems caused by long-term exposure.<ref name="fas.org">Renée Johnson for the Congressional Research Service January 7, 2010 [http://www.fas.org/sgp/crs/misc/RL33938.pdf Congressional Research Service Honey Bee Colony Collapse Disorder]</ref><ref name="beetox">Decourtye and Devillers (2010) [[doi:10.1007/978-1-4419-6445-8|"Ecotoxicity of Neonicotinoid Insecticides to Bees"]] in ''Insect Nicotinic Acetylcholine Receptors'' ed. by Steeve Hervé Thany (New York: Springer/Landes) Chapter 8, pp. 85-95, on p. 86</ref>

A report released in 2012 found a close relationship between the deaths of bees and the use of pneumatic drilling machines for the sowing of corn seeds coated with clothianidin and other neonicotinoid insecticides. In pneumatic drilling machines, seeds are sucked in, causing the erosion of fragments of the insecticide shell, which are then expelled with a current of air. Field tests found that foraging bees flying through dust released during the planting of corn seeds coated with neonicotinoid insecticides may encounter exposure high enough to be lethal. They concluded: "The consequent acute lethal effect evidenced in all the field sowing experiments can be well compared with the colony loss phenomena widely reported by beekeepers in spring and often associated to corn sowing."<ref name="tapparo2012">Tapparo ''et al'' (2012) [http://pubs.acs.org/doi/abs/10.1021/es2035152 "Assessment of the Environmental Exposure of Honeybees to Particulate Matter Containing Neonicotinoid Insecticides Coming from Corn Coated Seeds"] ''Environmental Science and Technology''</ref> Another field study released in 2012 looked at sublethal effects of clothianidin and imidacloprid in amounts that bees might be exposed to during foraging. Sublethal doses can affect orientation, foraging, learning ability and brood care. The study found: "clothianidin elicited detrimental sub-lethal effects at somewhat lower doses (0.5 ng/bee) than imidacloprid (1.5 ng/bee). Bees disappeared at the level of 1 ng for clothianidin, while we could register the first bee losses for imidacloprid at doses exceeding 3 ng."<ref name="schneider2012">Schneider ''et al'' (2012) [http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0030023 "RFID Tracking of Sublethal Effects of Two Neonicotinoid Insecticides on the Foraging Behavior of ''Apis mellifera''"] ''PLoS ONE''</ref>

In a 2012 study, scientists found that an analyses of bees found dead in and around hives from several apiaries in [[Indiana]] showed the presence of the neonicotinoid insecticides clothianidin and thiamethoxam. The research showed that the insecticides were present at high concentrations in waste [[talc]] that was exhausted from farm machinery during planting and that is left outside after cleaning the planting equipment. Talc is used in the vacuum system planters to keep pesticide treated seeds flowing freely and was studied by the investigators since the waste talc can be picked up by the wind, and could spread the pesticide to non-treated areas; they did not however investigate whether and how much pesticide spreads this way. The insecticides were also consistently found at low levels in soil up to two years after treated seed was planted, and on nearby dandelion flowers and corn pollen gathered by the bees.<ref>[http://www.purdue.edu/newsroom/research/2012/120111KrupkeBees.html "Researchers: Honeybee deaths linked to seed insecticide exposure"] January 11, 2012 ''(Purdue University News Service)''</ref><ref name="krupke2012">Krupke ''et al'' (2012) [http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0029268 "Multiple Routes of Pesticide Exposure for Honey Bees Living Near Agricultural Fields"] ''PLoS ONE''</ref> Also in 2012, researchers in Italy published findings that the pneumatic drilling machines that plant corn seeds coated with clothianidin and imidacloprid release large amounts of the pesticide into the air, causing significant mortality in foraging honey bees.<ref>{{cite journal |author1=Andrea Tapparo |author2=Daniele Marton |author3=[[Chiara Giorio]] |author4=Alessandro Zanella |author5=Lidia Soldà |author6=Matteo Marzaro |author7=Linda Vivan |author8=Vincenzo Girolami |year=2012 |title=Assessment of the Environmental Exposure of Honeybees to Particulate Matter Containing Neonicotinoid Insecticides Coming from Corn Coated Seeds |journal=Environmental Science & Technology |volume=46 |issue=5 |pages=2592–2599 |bibcode=2012EnST...46.2592T |citeseerx=10.1.1.454.6772 |doi=10.1021/es2035152 |pmid=22292570}}</ref>

Studies have shown that [[Asclepias|milkweed]] plants contaminated with clothianidin can have a detrimental effect on the development and survival of [[monarch butterfly]] [[caterpillar]]s.<ref>{{cite journal |last1=Knight |first1=Samantha M. |last2=Flockhart |first2=D. T. Tyler |last3=Derbyshire |first3=Rachael |last4=Bosco |first4=Mark G. |last5=Norris |first5=D. Ryan |date=July 2021 |title=Experimental field evidence shows milkweed contaminated with a common neonicotinoid decreases larval survival of monarch butterflies |journal=Journal of Animal Ecology |volume=90 |issue=7 |pages=1742–1752 |doi=10.1111/1365-2656.13492}}</ref><ref>{{cite journal |last1=Pecenka |first1=Jacob R. |last2=Lundgren |first2=Jonathan G. |date=April 2015 |title=Non-target effects of clothianidin on monarch butterflies |journal=The Science of Nature |volume=102 |issue=3-4 |pages=19 |doi=10.1007/s00114-015-1270-y}}</ref>

==== Data gaps ====

North American and European pesticide regulatory authorities have identified specific data gaps and uncertainties for which clothianidin manufacturers must provide data.<ref name="USEPA1" /><ref name="CN4">{{cite web |title=Evaluation Report ERC2011-01, under ''What Additional Scientific Information Is Being Requested?'' |url=http://www.hc-sc.gc.ca/cps-spc/pubs/pest/_decisions/erc2011-01/index-eng.php#a8 |url-status=dead |archive-url=https://web.archive.org/web/20120819141701/http://www.hc-sc.gc.ca/cps-spc/pubs/pest/_decisions/erc2011-01/index-eng.php#a8 |archive-date=19 August 2012 |access-date=15 August 2011 |publisher=Health Canada, Pest Management Regulatory Agency}}</ref><ref name="UK1x">{{cite web |title=Re-registration Requirements Following Further Annex I Inclusion Decisions, see Other updates section |url=http://www.pesticides.gov.uk/approvals.asp?id=2874 |access-date=16 August 2011 |publisher=U.K. Chemicals Regulation Directorate of the Health and Safety Executive}}</ref> Studies required of the manufacturers will further investigate clothianidin's:
* environmental persistence in soil and subsequent uptake in rotational crops
* availability in pollen and nectar
* long-term effects on honey bees and other pollinators
* [[Developmental immunotoxicology|developmental immunotoxicity]]
* effects on aerobic aquatic metabolism
* ability to leach from treated seeds and
* acute toxicity to freshwater invertebrates

The challenges associated with studying potential long-term effects of pesticides on honey bee colonies are well documented and include the inability to adequately monitor individual bee health or extrapolate effects on individuals to whole hives. Behavior changes between bees and/or colonies in laboratory or field test conditions versus natural environments also add to the challenges.<ref name="FR2">{{cite web |title=Weakening, collapse and mortality of bee colonies, pp.143-144 |url=http://www.anses.fr/Documents/SANT-Ra-MortaliteAbeillesEN.pdf |url-status=dead |archive-url=https://web.archive.org/web/20131014181637/http://www.anses.fr/Documents/SANT-Ra-MortaliteAbeillesEN.pdf |archive-date=14 October 2013 |access-date=15 August 2011 |publisher=French Food Safety Agency}}</ref> Studies submitted by Bayer AG to USEPA have provided some useful information about clothianidin's potential long-term effects on honey bees but outstanding questions remain. USEPA's analysis of nine pollinator field studies submitted concluded that three were invalid, so EPA did not use the data they provided in making its regulatory decision for clothianidin. EPA classified the remainder as supplemental, generally because Bayer AG conducted the studies without EPA first approving the protocols.<ref name="USEPA6">{{cite web |title=Data Evaluation Record, Honey Bee - Field Testing for Pollinators MRID 45422440 |url=http://www.epa.gov/pesticides/chemical/foia/cleared-reviews/reviews/044309/044309-2003-03-20L-45422440.pdf |access-date=15 August 2011 |publisher=USEPA}}</ref><ref name="USEPA8">{{cite web |title=Data Evaluation Record, Honey Bee - Field Testing for Pollinators MRID 45422439 |url=http://www.epa.gov/pesticides/chemical/foia/cleared-reviews/reviews/044309/044309-2003-03-20K-45422439.pdf |access-date=15 August 2011 |publisher=USEPA}}</ref><ref name="USEPA9">{{cite web |title=Data Evaluation Record, Honey Bee - Field Testing for Pollinators MRID 45422431 |url=http://www.epa.gov/pesticides/chemical/foia/cleared-reviews/reviews/044309/044309-2003-07-16a-45422431.pdf |access-date=15 August 2011 |publisher=USEPA}}</ref><ref name="USEPA11">{{cite web |title=Data Evaluation Record, Honey Bee - Field Testing for Pollinators MRID 45422436 |url=http://www.epa.gov/pesticides/chemical/foia/cleared-reviews/reviews/044309/044309-2003-03-19b-45422436.pdf |access-date=15 August 2011 |publisher=USEPA}}</ref><ref name="USEPA12">{{cite web |title=Data Evaluation Record, Honey Bee - Field Testing for Pollinators MRID 45422437 |url=http://www.epa.gov/pesticides/chemical/foia/cleared-reviews/reviews/044309/044309-2003-03-19c-45422437.pdf |access-date=15 August 2011 |publisher=USEPA}}</ref><ref name="USEPA13">{{cite web |title=Data Evaluation Record, Honey Bee - Field Testing for Pollinators MRID 45422435 |url=http://www.epa.gov/pesticides/chemical/foia/cleared-reviews/reviews/044309/044309-2003-03-19a-45422435.pdf |access-date=15 August 2011 |publisher=USEPA}}</ref><ref name="USEPA14">{{cite web |title=Data Evaluation Record, Honey Bee - Field Testing for Pollinators MRID 45422438 |url=http://www.epa.gov/pesticides/chemical/foia/cleared-reviews/reviews/044309/044309-2003-03-19a-45422438.pdf |access-date=15 August 2011 |publisher=USEPA}}</ref><ref name="USEPA15">{{cite web |title=Data Evaluation Record, Honey Bee - Field Testing for Pollinators MRID 45422434 |url=http://www.epa.gov/pesticides/chemical/foia/cleared-reviews/reviews/044309/044309-2003-03-20i-45422434.pdf |access-date=15 August 2011 |publisher=USEPA}}</ref> Supplemental studies are ones that don't definitively answer uncertainties but still provide some data that might be useful in characterizing risk.<ref name="USEPA10">{{cite web |title=Reclassification of MRID 46907801 Data Package for Clothianidin |url=http://www.epa.gov/pesticides/chemical/foia/cleared-reviews/reviews/044309/044309-2010-12-22a.pdf |access-date=15 August 2011 |publisher=USEPA}}</ref> Indicative of the rapid advance of regulators' understanding of pollinator science, USEPA first accepted one of the studies as sound science in 2007, then reclassified it as invalid in November 2010 only to reclassify it as supplemental one month later.<ref name="USEPA16">{{cite web |title=Data Evaluation Record, Honey Bee - Field Testing for Pollinators MRID 46907801/46907802 |url=http://www.epa.gov/pesticides/chemical/foia/cleared-reviews/reviews/044309/044309-090201-113501-079801-2010-12-22a.pdf |access-date=15 August 2011 |publisher=USEPA}}</ref> The changes in EPA's classification of this study have no effect on the regulatory status for clothianidin in the U.S. because the study does not provide data with which EPA can legally justify altering its 2003 registration decision.<ref name="USEPA17" /> An international group of pesticide regulators, researchers, industry representatives, and beekeepers is working to develop a study protocol that will definitively answer remaining questions about the potential long-term effects on bee colonies and other pollinators.<ref name="SETAC">{{cite web |title=January 24, 2011 International SETAC Pellston Workshop |url=http://www.setac.org/node/155#item_487 |url-status=dead |archive-url=https://web.archive.org/web/20110919024215/http://www.setac.org/node/155#item_487 |archive-date=19 September 2011 |access-date=15 August 2011 |publisher=The Society of Environmental Toxicology and Chemistry (SETAC)}}</ref>

=== Mammals ===

Clothianidin is moderately toxic in the short-term to mammals that eat it, and long-term ingestion may result in reproductive and/or developmental effects.<ref name="USEPA1" /><ref name="AU1" /><ref name="AU2" /> Using laboratory test animals as surrogates for humans and dosages much higher than are expected from exposure related to actual use, rats showed low short-term oral, dermal, and inhalation toxicity to clothianidin. For mice, acute oral toxicity was moderate to high. Rabbits showed little to no skin or eye irritation when exposed to clothianidin, and the skin of guinea pigs was not sensitized by it. When extrapolated to humans, these results suggest that clothianidin is moderately toxic through oral exposure, but toxicity is low through skin contact or inhalation. While clothianidin may cause slight eye irritation, it is not expected to be a skin sensitizer or irritant. Clothianidin does not damage genetic material nor is there evidence that it causes cancer in rats or mice; it is unlikely to be a human carcinogen.<ref name="USEPA1" /><ref name="AU1" /><ref name="CN3" />

Permissible amounts of clothianidin residue on food and animal feed vary from crop to crop and nation to nation. However, regulatory authorities around the globe emphasize that when used according to the label instructions, clothianidin residues on food are not expected to exceed safe levels (as defined by each nation's laws and regulations).<ref name="CN3">{{cite web|title=Evaluation Report ERC2011-01, Clutch 50 WDG, Arena 50 WDG and Clothianidin Insecticides|url=http://www.hc-sc.gc.ca/cps-spc/pubs/pest/_decisions/erc2011-01/index-eng.php|publisher=Health Canada, Pest Management Regulatory Agency|access-date=15 August 2011|archive-url=https://web.archive.org/web/20120819141701/http://www.hc-sc.gc.ca/cps-spc/pubs/pest/_decisions/erc2011-01/index-eng.php|archive-date=19 August 2012|url-status=dead}}</ref><ref name="CN2">{{cite web|title=Proposed Maximum Residue Limit PMRL2011-30, Clothianidin|url=http://www.hc-sc.gc.ca/cps-spc/pest/part/consultations/_pmrl2011-30/pmrl2011-30-eng.php|publisher=Health Canada, Pest Management Regulatory Agency
| access-date=12 August 2011}}</ref><ref name="AU3">{{cite web|title=Advice Summary, Application for Variation of a Registered Chemical Product|url=http://www.apvma.gov.au/advice_summaries/42490.pdf|publisher=Australian Pesticides and Veterinary Medicines Authority|access-date=15 August 2011|archive-url=https://web.archive.org/web/20110930163255/http://www.apvma.gov.au/advice_summaries/42490.pdf|archive-date=30 September 2011|url-status=dead}}</ref><ref name="USEPA3">{{cite web|title=U.S. Federal Register Notice: Clothianidin; Pesticide Tolerances
| url=http://edocket.access.gpo.gov/2009/E9-29339.htm|publisher=USEPA|access-date=15 August 2011}}</ref><ref name="UK5">{{cite web|title=Keeping our Food Safe: Measuring, Monitoring and Assessing Residues.|url=http://www.pesticides.gov.uk/food_safety.asp?id=632|publisher=U.K. Chemicals Regulation Directorate of the Health and Safety Executive|access-date=16 August 2011}}</ref><ref name="UK6">{{cite web|title=Official Journal of the European Union, amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for chlorothalonil clothianidin, difenoconazole, fenhexamid, flubendiamide, nicotine, spirotetramat, thiacloprid and thiamethoxam in or on certain products|url=http://www.pesticides.gov.uk/uploadedfiles/Web_Assets/PSD/Com_Reg_765_2010.pdf|publisher=U.K. Chemicals Regulation Directorate of the Health and Safety Executive|access-date=16 August 2011}}</ref>

=== Aquatic life ===

In the 2003 United States EPA assessment report it was stated that clothianidin should not present a direct acute or chronic [[aquatic toxicity|risk to freshwater and estuarine/marine fish]], or a risk to terrestrial or aquatic vascular and nonvascular plants. It is considered to be toxic to aquatic invertebrates if disposal of wastes according to disposal instructions are not followed.<ref name="USEPA1"/> The Pest Management Regulatory Agency of Canada lists it as "very highly toxic" to aquatic invertebrates, but only slightly toxic to fish.<ref name="CN1" />

In the 2003 EPA report it was stated that although no water monitoring studies had been conducted, due to the extreme mobility and persistence of clothianidin in the environment, clothianidin has the properties of a chemical which could lead to widespread groundwater contamination should the registrant (e.g. Bayer or Takeda) request field uses involving direct application of clothianidin to the land surface.  In a 2010 EPA report, it was noted that the registrant (e.g. Bayer or Takeda) had recently added new uses on the labels, including using the pesticide directly applied to the soil surface/foliage at much higher application rate than as specified in 2003.  As a result, the potential for clothianidin to move from the treated area to the nearby surface water body under the new uses is much greater than with use as a seed treatment.<ref>[http://grist.files.wordpress.com/2010/12/memo_nov2010_clothianidin.pdf UNITED STATES ENVIRONMENTAL PROTECTION AGENCY MEMORANDUMSUBJECT: Clothianidin  Registration  of Prosper  T400  Seed  Treatment  on  Mustard  Seed (Oilseed and Condiment) and Poncho/Votivo Seed Treatment on Cotton] Joseph DeCant, Ecologist Michael Barrett, Chemist Environmental Risk Branch V, Environmental Fate and Effects Division ''grist.files.wordpress.com'', accessed 11 June 2019</ref>

=== Birds ===

According to the EPA, clothianidin is practically non-toxic to test bird species that were fed relatively large doses of the chemical on an acute basis. However, EPA assessments show that exposure to treated seeds through ingestion may result in chronic toxic risk to non-endangered and endangered small birds (e.g., songbirds). [[Bobwhite quail]] eggshell thickness was affected when the test birds were given a diet consisting of relatively large amounts of clothianidin-treated seeds.<ref name="USEPA1" /><ref name="AU1" /><ref name="AU2" /> The Pest Management Regulatory Agency of Canada lists clothianidin as "moderately toxic" to birds.<ref name="CN1" />

=== Environmental persistence ===

Laboratory and field testing shows that clothianidin is persistent and mobile in the environment, stable to [[hydrolysis]], and has potential to leach to [[ground water]] and be transported via runoff to surface water bodies. Worst-case scenario estimates indicate that if applied at the maximum rate repeatedly over years, clothianidin has the potential to accumulate in the top 15&nbsp;cm of soil. However, the Australian pesticide authority's review of rotational crop studies determined that clothianidin generally is not taken up by crops sown in fields where treated corn seeds were planted, even when the test corn seeds were coated with an intentionally large amount of the chemical (2&nbsp;mg/seed vs the authorized maximum application rate of 1.25&nbsp;mg).<ref name="USEPA1" /><ref name="AU1" />

=== Risk mitigation ===

Once laboratory and field data identify hazards associated with a chemical, regulatory authorities take different approaches to mitigate those hazards and bring the risks down to acceptable levels, as defined by each nation's laws and regulations. For clothianidin, hazard mitigation includes establishing the maximum amount of the chemical that can be used (e.g. kg/acre or mg/seed), requiring buffer zones around treated fields to protect water supplies, and prohibiting the use of low-technology seed treatment methods or equipment that can send clouds of clothianidin dust or spray up into the air during seeding operations.<ref name="USEPA1" /><ref name="AU1" /><ref name="CN3" /><ref name="UK7">{{cite web|title=Notice of Approval Number: 0065 of 2011, Approval and Consent for a Plant Protection Product|url=https://secure.pesticides.gov.uk/pestreg/getfile.asp?documentid=15675|publisher=U.K. Chemicals Regulation Directorate of the Health and Safety Executive|access-date=16 August 2011}}</ref>

Clothianidin users are also required to monitor the weather and not use the chemical or seeds treated with it on windy days or when rain is forecast. Workers are protected from clothianidin exposure through requirements for personal protective equipment, such as long-sleeve shirts, gloves, long pants, boots, and face mask or respirators as appropriate. To reduce the possibility that birds and small mammals might eat treated seeds, users are required to ensure that soil covers planted seeds and that any spilled seed is picked up.

== Regulation ==

=== Neonicotinoids banned by the European Union ===
{{See also|Neonicotinoid#European Union}}

In 2012, several peer reviewed independent studies were published showing that neonicotinoids, including clothianidin, had previously undetected routes of exposure affecting bees including through dust, pollen, and nectar; that sub-nanogram toxicity resulted in failure to return to the hive without immediate lethality, the primary symptom of colony collapse disorder; and showing environmental persistence in agricultural irrigation channels and soil. These reports prompted a formal peer review by the [[European Food Safety Authority]] (EFSA), which stated in January 2013 that neonicotinoids, including clothianidin, pose an unacceptably high risk to bees, and that the industry-sponsored science upon which regulatory agencies' claims of safety have relied on may be flawed and contain several data gaps not previously considered. Their review concluded, "A high acute risk to honey bees was identified from exposure via dust drift for the seed treatment uses in maize, oilseed rape and cereals. A high acute risk was also identified from exposure via residues in nectar and/or pollen."<ref name="EFSA">European Food Safety Authority (16 January 2013) [https://efsa.onlinelibrary.wiley.com/doi/abs/10.2903/j.efsa.2013.3066 "Conclusion on the peer review of the pesticide risk assessment for bees for the active substance clothianidin"] ''EFSA Journal'' '''11'''(1):3066.</ref><ref>European Food Safety Authority (2012) [https://efsa.onlinelibrary.wiley.com/doi/abs/10.2903/j.efsa.2012.2792 "Assessment of the scientific information from the Italian project 'APENET' investigating effects on honeybees of coated maize seeds with some neonicotinoids and fipronil"] ''EFSA Journal'' '''10'''(6):2792</ref> In April 2013, the [[European Union]] voted for a two-year restriction on neonicotinoid insecticides.<ref>Tania Rabesandratana for ScienceInsiderApril 29, 2013 [https://www.science.org/content/article/european-commission-goes-ahead-controversial-pesticide-ban European Commission Goes Ahead With Controversial Pesticide Ban]</ref>  The ban restricted the use of imidacloprid, clothianidin, and thiamethoxam for use on crops that are attractive to bees (maize, cotton, sunflower, and rapeseed), and goes into effect on December 1, 2013. Eight nations voted against the motion, including the British government which  argued that the science was incomplete.<ref name=victory>{{cite news|title='Victory for bees' as European Union bans neonicotinoid pesticides blamed for destroying bee population|work=The Independent|date=29 April 2013|author=Charlotte McDonald-Gibson|url=https://www.independent.co.uk/environment/nature/victory-for-bees-as-european-union-bans-neonicotinoid-pesticides-blamed-for-destroying-bee-population-8595408.html|access-date=1 May 2013}}</ref>

Following on the release of the EFSA report in January 2013, the UK Parliament has asked manufacturer [[Bayer Cropscience]] to explain discrepancies in evidence they have submitted to an investigation.<ref>Damian Carrington (16 January 2013) [https://www.theguardian.com/environment/2013/jan/16/insecticide-unacceptable-danger-bees "Insecticide 'unacceptable' danger to bees, report finds"] ''The Guardian''</ref>

In February 2018, the [[European Food Safety Authority]] published a new report indicating that [[neonicotinoids]] pose a serious danger to both [[honey bee]]s and wild [[bee]]s.<ref>Damian Carrington, [https://www.theguardian.com/environment/2018/feb/28/total-ban-on-bee-harming-pesticides-likely-after-major-new-eu-analysis "Total ban on bee-harming pesticides likely after major new EU analysis"], ''[[The Guardian]]'', 28 February 2018 (page visited on 29 April 2018).</ref> In April 2018, the member states of the [[European Union]] decided to ban the three main neonicotinoids (clothianidin, [[imidacloprid]] and [[thiamethoxam]]) for all outdoor uses.<ref>Damian Carrington, [https://www.theguardian.com/environment/2018/apr/27/eu-agrees-total-ban-on-bee-harming-pesticides "EU agrees total ban on bee-harming pesticides "], ''[[The Guardian]]'', 27 April 2018 (page visited on 29 April 2018).</ref>

== See also ==

*[[Bees and toxic chemicals]]
*[[Pesticide misuse]]
*[[Pesticide toxicity to bees]]
*[[Pollinator decline]]

== References ==
{{Reflist|30em}}

{{Commons category|Clothianidin}}

{{Portal bar|Chemistry|Insects}}

[[Category:Insecticides]]
[[Category:Nitroguanidines]]
[[Category:Thiazoles]]
[[Category:Neonicotinoids]]
[[Category:Chloroarenes]]