What’s New, What’s Hot in Pesticide Law and Policy Program – RODENTICIDES ACTIONS Lawrence E. Culleen Arnold & Porter LLP 555 Twelfth St., NW Washington, DC 20004

Brief History  Re-registration consideration during 1990’s  R.E.D. issued 1998  Several categories of active ingredients considered: –FGARs –SGARs –Non-anticoagulants 2

Brief History (cont’d.)  1998 R.E.D. included mitigation measures for both consumer and non-consumer use products and EPA stated ecological risks needed for further review  EPA formed Rodenticide Stakeholder Workgroup  RSW findings issued late 2000  Late 2001 certain mitigations in R.E.D. rescinded (bittering agents) 3

Brief History (cont’d.)  Litigation ensued over 2001 rescission –West Harlem Env. Action v. EPA, 380 F. Supp. 2d 289 (S.D.N.Y. 2005) –R.E.D. “remanded” to EPA on issue of children’s exposures  “Comparative” ecological risk assessment vetted  Risk Mitigation proposal 2007 Reclassify SGARs as RUPs Consumer use products in bait stations 4

Risk Mitigation Decision – May 2008  Registrants must “voluntarily” cancel non- conforming products  SGARs may not be labeled/sold for consumer use  FGARs and non-anticoagulants must be sold with bait stations  Pellets/grains and liquids may not be sold to consumers (even in bait stations) Concerns: “kids” and wildlife (including “secondary exposures”) 5

Risk Mitigation Decision – May 2008 (cont’d.)  PCOs may continue to buy and use all products  Manufacturers may continue to sell in bulk at farming and rural supply centers  Below ground use out of doors may continue  Registrants must “voluntarily” cancel non- conforming products  Products that fail to comply by June 2011 “would be considered misbranded” 6

Litigation  Reckitt Benckiser v. EPA –District Court – 666 F. Supp. 2d 131 (D.D.C. 2009) No subject matter jurisdiction because determination that the RMD could be enforced outside of Section 6 was “regulatory action” under Section 4 and thus only reviewable by the court of appeals –Court of Appeals – 613 F.3d 1131 (D.C. Cir. 2010) EPA determination that it may bring enforcement action without Section 6 process is final agency action, not subject to Section 4 and not an order following a hearing under Section 16, so proper jurisdiction is in District Court –District Court – 762 F. Supp. 2d 34 (D.D.C. 2011) EPA lacks authority under FIFRA to bring a misbranding action instead of a cancellation action for products that do not comply with the RMD  Woodstream v. EPA (filed May 9, 2011 – D.D.C.) –Woodstream alleges that EPA mis-used conditional registration authority by imposing time limitations linked to RMD compliance –Cross- Motions for summary judgment pending 7

EPA Actions  Press releases – June 7, 2011  Fed. Reg. – Sept. 7, 2011  Press statement – Nov. 3,

SAP Meetings to be Held Nov. 29 – Dec. 1, Products 4 “pending” applications being “denied” 9

Process  SAP (Nov. 29 – Dec. 1, 2011)  Consultation with USDA and HHS  EPA considers input and may issue NOIC to registrants  Recipients and affected parties may request a hearing  Hearing is before ALJ 10

Process (cont’d.)  Last hearings were in 1980s  Those proceedings lasted months/years  Standard for cancellation –A product “when used in accordance with widespread and commonly recognized practice, generally causes unreasonable adverse effects on the environment.” –“Unreasonable” includes risks and benefits consideration  “Public health” products –EPA shall “weigh any risks of the pesticide against the health risks such as the diseases transmitted by the vector to be controlled by the pesticide.” FIFRA 2(bb) 11