Proposed Risk Mitigation Decision; Notice of Availability.
This notice announces the availability of EPA's proposed risk mitigation decision for nine rodenticides, the economic impact assessment for the proposed risk mitigation decision, the revised comparative ecological risk assessment, updated human health and ecological incident reports, and other related documents, and opens a 60-day public comment period on the proposed risk mitigation decision. The nine rodenticides covered by this risk mitigation decision are brodifacoum, bromadiolone, difethialone, chlorophacinone, diphacinone, warfarin, zinc phosphide, bromethalin, and cholecalciferol. Documents available:

Extension of Comment Period to January 21, 2005, re: Rodenticides; Availability of Revised Comparative Ecological Risk Assessment. Documents available are:
• Potential Risks of Nine Rodenticides to Birds and Nontarget Mammals: a Comparative Approach - July 2004 (230 pages)
• Update to the Overview of the Rodenticide Comparative Ecological Assessment - September 9, 2004 (4 pages)
• Analysis of Rodenticide Bait Use - September 10, 2004 (43 pages)
• EFED Response to USDA/APHIS’ “Partner Review Comments: Preliminary Analysis of Rodenticide Bait Use and Potential Risks of Nine Rodenticides to Birds and Nontarget Mammals: A Comparative Approach (June 9, 2004)” - September 7, 2004 (24 pages)
• Response to Public Comments on EFED's Risk Assessment: "Potential Risks of Nine Rodenticides to Birds and Nontarget Mammals: a Comparative Approach", dated December 19, 2002- July 17, 2004 (24 pages)
• "Potential Risks of Nine Rodenticides to Birds and Nontarget Mammals: A Comparative Approach"; revised document dated July 2004 - July 22, 2004 (2 pages)

Excerpts from Potential Risks of Nine Rodenticides to Birds and Nontarget Mammals: a Comparative Approach - July 2004 (230 pages)
-- Mammalian predators and scavengers are at risk from feeding on animals poisoned with anticoagulant baits. Although the non-anticoagulant rodenticides appear to be much less hazardous to secondary consumers, confirmatory data are still needed to make this assumption for bromethalin and cholecalciferol baits.

-- Bromethalin, a diphenylamine, is a neurotoxicant that causes respiratory arrest from inadequate nerve impulse transmission after fluid build-up and demyelination inside the central nervous system (Spaulding and Spannring 1988, Hyngstrom et al. 1994).

-- Risks to Nontarget mammals ... Too few data are available to adequately assess potential risks of either bromethalin or cholecalciferol (page 85).

-- Little information is available on methodology for detecting bromethalin or cholecalciferol in body tissues (page 90).

-- Lack of data for some rodenticides accounts for the most uncertainty in the comparative analysis model results. Data gaps include no secondary-hazards data for difethialone and few for bromethalin and cholecalciferol (page 105).

-- Two factors are identified as contributing the greatest uncertainty to the analysis: (1) missing data, especially secondary mortality data for difethialone, bromethalin, and cholecalciferol, and blood and liver retention values for a number of rodenticides; ... (page 149)

Availability of Revised Comparative Ecological Risk Assessment. Note from FAN: Bromethalin contains both bromide and fluoride. From the research performed by FAN's Pesticide Project, this combination induces the most severe effects on the brain.
Documents available are:
• Potential Risks of Nine Rodenticides to Birds and Nontarget Mammals: a Comparative Approach - July 2004 (230 pages)
• Update to the Overview of the Rodenticide Comparative Ecological Assessment - September 9, 2004 (4 pages)
• Analysis of Rodenticide Bait Use - September 10, 2004 (43 pages)
• EFED Response to USDA/APHIS’ “Partner Review Comments: Preliminary Analysis of Rodenticide Bait Use and Potential Risks of Nine Rodenticides to Birds and Nontarget Mammals: A Comparative Approach (June 9, 2004)” - September 7, 2004 (24 pages)
• Response to Public Comments on EFED's Risk Assessment: "Potential Risks of Nine Rodenticides to Birds and Nontarget Mammals: a Comparative Approach", dated December 19, 2002- July 17, 2004 (24 pages)
• "Potential Risks of Nine Rodenticides to Birds and Nontarget Mammals: A Comparative Approach"; revised document dated July 2004 - July 22, 2004 (2 pages)

NOTE: Comment period extended to January 21, 2005 - see above

Reopening of Comment Period. This document reopens the public comment period established in the Federal Register of January 29, 2003. In that document, EPA announced the availability of the preliminary comparative ecological assessment for nine rodenticides and invited comment on issues directly associated with the nine rodenticides that were included in the assessment. Due to the many requests received for additional time to comment, EPA is hereby reopening the comment period, which was set to end on March 31, 2003, to May 30, 2003 -- see ``Potential Risks of Nine Rodenticides to Birds and Nontarget Mammals: A Comparative Approach." [See also External Peer Review of this document.]

Rodenticides; Availability of Preliminary Comparative Ecological Assessment. This notice announces the availability of the new assessment for nine rodenticides, which included those addressed in the Reregistration Eligibility Decisions (REDs) for the the rodenticide cluster (brodifacoum, bromadiolone, bromethalin, chlorophacinone, diphacinone,) and zinc phosphide, as well as three other rodenticides, warfarin, difethialone, and cholecalciferol. This notice also starts a 60-day public comment period for the preliminary comparative ecological risk assessment - see ``Potential Risks of Nine Rodenticides to Birds and Nontarget Mammals: A Comparative Approach.'' Comments are to be limited to issues directly associated with the nine rodenticides that are included in the risk assessment which has been placed in the docket and should be limited to issues raised in the document. [See also External Peer Review of this document.]

[FAN comment: this document has little solid information on bromethalin. For the grave risks associated with bromethalin see Abstracts on bromethalin. EC.]

-- Brodifacoum and bromethalin are used under FIFRA emergency exemptions to control introduced rats on U. S. islands in the Pacific Ocean [p 9].
-- Comparative anticoagulant studies: ... No hazard data are available for bromethalin. Some whole-body residue data are available for zinc phosphide but none was found for cholecalciferol or bromethalin[p 35].
-- Potential Secondary Risks Birds ... Some information is available for zinc phosphide, but additional data are needed to characterize potential secondary risks of bromethalin and cholecalciferol [p 74].
-- Nontarget mammals ... Too few data are available to adequately assess potential risks of either bromethalin or cholecalciferol [p 78].
-- Incident Data: Birds and Nontarget Mammals ... Little information is available on methodology for detecting bromethalin or cholecalciferol in body tissues [p 83].
-- Conclusions ... Data gaps include no secondary-hazards data for difethialone and few for bromethalin and cholecalciferol [p 95]. ... Zinc phosphide potentially poses minimal risks to either predatory birds or mammals, but insufficient data are available for bromethalin and cholecalciferol [p 98].
-- Acute toxicity reference values... Two factors are identified as contributing the greatest uncertainty to the analysis: (1) missing data, especially secondary mortality data for difethialone, bromethalin, and cholecalciferol, and blood and liver retention values for a number of rodenticides [p 135-136]...
-- Attachment D: Incident Data For Birds and Nontarget Mammals... There are no incident data for bromethalin and cholecalciferol [p 170].

AGREVO - Request to voluntarily cancel 2 pesticide registrations: Gold Crest Vengeance Rodenticide, EPA Reg. No. 000432-00746; and Gold Crest Vengeance Rodenticide Small Bait Packs, EPA Reg. No. 000432-00748.

AGREVO - Request to Voluntarily Cancel Pesticide Registration for Gold Crest Vengeance Rodenticide. EPA Reg. No. 000432-00746.

OPP-34240

Case Number 2765