UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C

. 20460 

### JAN 16 2013

OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION MEMORANDUM

SUBJECT: FROM:

THRU:

TO: BEAD Chemical Profile for Registration Review: Niclosamide (077401) Colwell Cook,

# Entomologist~~ Biological Analysis Branch Rafael Prieto, 

### Environmental Protection Specialisa 

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# -P**~** Science Information and Analysis Branch 

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# v7**'""'-** JohnFaulkner, Economist 

# \J...JAll Economic Analysis Branch

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### ~**~iological** and Economic011 Anl sis Division (7503P) Arnet Jones, Chief Biological Analysis Branc Diann Sims, Chief 

# J{1**"? ~** **Lr~~r­** Science Information and Analysis Branch Timothy Kiely, Chief 

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# 0 Economic Analysis Branch \.} ) 

# 'fA-() Biological and Economic Analysis Division (7503P) Kelly Ballard, Chemical Review Manager Risk Management and ImplementationBranch 1 Pesticide Re-evaluation Division (7508P) 

### Product Review Panel date: November 28,2012 INTRODUCTION The purpose ofthis document is to convey usage information and a broad overview ofthe pest managementroles ofpesticides that are beginning to undergo registrationreview. The anticipated audience consists ofthe team ofEPA staffcurrently evaluatingthe registration status ofniclosamide, and eventually the general public. This documentbuilds upon the data already provided inthe usage and label use datapackages that are also provided to Registration Review

1teams by BEAD. The document is based on information and data available to BEAD as of November 19, 2012. Niclosamide is a critically importantpesticide. It is a chloronitrophenol derivative that is used to kill Atlantic sea lamprey larvae, Petromyzon marinus, in combinationwith another lampricide, 3- trifluoromethyl-4-nitrophenol, TFM (EPA 1999; USGS 2012 Focus Meeting). These invasive pests are aggressive parasites offish and have reduced the populations ofnative fish in all ofthe Great Lakes (University ofWisconsin Sea Grant Institute 2002). Sealampreys are native to the Atlantic Ocean. They are an ocean, eel-like, fish that spawn infresh water. Theywere found in Lake Ontario in 1835, and introduced into Lake Erie in 1921, probablythroughthe Weiland Canal (USDA 2011). Niclosamide targets the mitochondria and uncouples oxidative phosphorylation, whichresults inthe lampreys notbeing able to meettheir energy demands (Bayluscide Label). These products are manufactured by and for the U.S. Fish and Wildlife Services. HISTORY OF BEAD ASSESSMENTS FORNICLOSAMIDE BEAD reviewed an emergency exemption from Mississippi (EPA, 2000) requesting the use of niclosamide to control the ram's hom snail, genus Planorbis, which is the intermediate host ofa trematode that infects many species offish. BEAD concluded that catfish farmers would suffer a significant economic loss withthe pest, since there were no alternatives for control. It appears thatthis could have been an ongoing problem. In 2004, niclosamide was registered for use against freshwater snails incatfish and fish ponds, when the ponds do not contain fish. FORMULATIONS Niclosamide is formulated as a granular, wettable powder and emulsifiable concentrate. USE SITES Agricultural Use Sites Niclosamide is used onfish and catfishponds as a watertreatment, when no fish are present. Non-Agricultural Use Sites Niclosamide is used only for aquatic sites [seines, potable water, irrigation supply systems, ponds (ornamental and fish), impounded water, lakes and ponds], and water treatment for rivers and streams to control sea lamprey. Granular niclosamide is used in lentic areas where the larvae live in still waters. Itis sprayed over infested area, sinks to bottom, and dissolves. Larvae infest some lentic areas associated with streams (EPA, 2012). USAGE Available data from proprietary data, USDA/NASS, and CaliforniaDepartmentofPesticide Regulation databases did not show any uses for this chemical oneither agricultural crops ornonagricultural sites. In 2011 nine lentic areas were treated inthe U.S. and seventeen areas were

2treated in Canada. In 2010 and 2011 over 2000 acres were treated inthe St. Marys River. The largest lentic areas are interconnecting waterways (St. Marys, St. Clair Rivers, which border Michigan and Canada) (EPA, 2012). BIOLOGICAL ASPECTS The sea lamprey is an invasive species introduced into the Great Lakes. This blood-sucking fish has devastated the native fishes ofthe Great Lakes (University ofWisconsin Sea Grant Institute 2002). Niclosamide, in conjunction with TFM, is the lampricide used to control sea lamprey larvae intributaries to the Great Lakes, the Finger Lakes and Lake Champlain (EPA 1999). These are the onlyproducts available to control sealampreys. CONCLUSION The sea lamprey is an invasive, aggressive pest thathas greatly impacted the native fish ofthe Great Lakes, and itis critical to control. Niclosamide is a major lampricide, used in conjunction with TFM, to control this significantpest; itis highly restricted to the tributaries ofthe Great Lakes; and can only be purchased and applied by certified applicators ofthe U.S. Fish and Wildlife Services, Fisheries and Oceans Canada, and provincial and state fish and game employees. In addition, there are no alternatives to control freshwater snails infish ponds. INFORMATION THAT MAY BE USEFUL FORBEAD'S FUTURE WORK ON NICLOSAMIDE The U.S. Fish and Wildlife Services will provide usage data to the Agency when it becomes available. BEAD will also need data regarding the use ofthis chemical in snail control. REFERENCES: EPA. 1999. Niclosamide Reregistration Eligibility Document (RED). Available at: http://www.epa.gov/oppsrrd1!REDs/3082red.pdf

. Accessed November 19, 2012. EPA, 2000. BEAD Review ofDocumentation in Support ofan Emergency Exemption for the Use of Niclosamide (Bayluscide®) in Catfish Ponds to Control the Rams Hom Snail (00-MS-0021), September 13. EPA, 2012. Registration Review Focus Meeting with Fish and Wildlife Service, U.S. Geological Survey, and Great Lakes Fishery Commission. November 5, 2012 NYS Department ofEnvironmental Conservation. 2011. Found at: http://www.dec.ny.gov/animals/7240.html. Accessed: August 6, 2009. USDA. 2011. Sealamprey. Sealamprey control. Found at: http://www.invasivespeciesinfo.gov/aquatics/lamprey.shtml. Accessed: August 6, 2009. University ofWisconsin Sea Grant Institute. 2002. Sea lamprey. Found at: http://seagrant.wisc.edu/greatlakesfish/sealamprey.html. Accessed: August 6, 2009.



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