Whats New Whats Hot in Pesticide Law and

What’s New, What’s Hot in Pesticide Law and Policy Program – RODENTICIDES ACTIONS Lawrence E. Culleen Lawrence. Culleen@aporter. com 202. 942. 5477 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formed Rodenticide Stakeholder Workgroup § RSW findings issued late 2000 § Late 2001 certain mitigations in R. E. D. rescinded (bittering agents) 3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. 2 d 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 Concerns: “kids” and wildlife (including “secondary exposures”) § Registrants must “voluntarily” cancel nonconforming 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) 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 nonconforming products § Products that fail to comply by June 2011 “would be considered misbranded” 6

Litigation § Reckitt Benckiser v. EPA – District Court – 666 F. Supp. 2 d 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. 3 d 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 – 762 F. Supp. 2 d 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, 2011 8

SAP Meetings to be Held Nov. 29 – Dec. 1, 2011 20 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 1980 s § 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