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Carbofuran Cancellation Process

January 8, 2008

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Carbofuran is an N-methyl carbamate insecticide and nematicide registered to control pests in soil and on leaves in a variety of field, fruit, and vegetable crops. No residential uses are registered.

As of January 2008, EPA has determined that all products containing carbofuran generally cause unreasonable adverse effects on humans and the environment, and are ineligible for reregistration. This Web page provides information about the status of the Agency's initiative to obtain cancellation, voluntary or otherwise, of all pesticide products containing carbofuran.

SAP Review of NOIC

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Status Update

In August 2006, EPA issued an Interim Reregistration Eligibility Decision (IRED)(PDF) (44 pp, 393k, about PDF) document, in which it announced its determination that all products containing carbofuran are not eligible for reregistration. This decision was based on robust public input and scientific review under the Agency’s full public participation process for pesticides undergoing reregistration. Since that determination, the registrant submitted a number of studies and other documents to the Agency for review.

EPA has reviewed all submitted data, as well as additional data developed by the EPA Office of Research and Development, and continues to believe that carbofuran registrations do not meet the risk/benefit standard of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and that the tolerances do not meet the safety standard of the Federal Food, Drug and Cosmetic Act (FFDCA). However, the Agency has concluded that a transition period for certain uses and retention of certain import tolerances are justified, provided all other uses are canceled, voluntarily or otherwise, and all other tolerances are revoked.

EPA has developed a draft Notice of Intent to Cancel (NOIC) All Carbofuran Registrations, consistent with FIFRA. As required by the statute, EPA is asking the Secretary of Agriculture to comment on EPA's analysis of the impact of the proposed cancellation on the agricultural economy. EPA also is asking the FIFRA Scientific Advisory Panel (SAP) to review and comment on the Agency's proposed action in terms of human health and the environment.

Consistent with FIFRA, EPA is asking the SAP to peer review the science supporting the Agency's risk management decision; EPA is not asking the SAP to review the Agency's risk management decision. If the process proceeds to a final NOIC and the registrant requests a hearing before an administrative law judge, benefits and risks will be fully addressed during that proceeding.

The public docket (EPA-HQ-OPP-2007-1088 at Regulations.gov ) opened on January 8, 2008. The SAP meeting, which is open to the public, is scheduled to occur on February 5 - 8, 2008, at an EPA Office of Pesticide Programs conference room at One Potomac Yard in Arlington, Virginia. Details about the meeting, including how and when to submit oral and written comments are provided in the Agency’s November 20, 2007, Federal Register Notice that announced the meeting.

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New Data Since the August 2006 IRED

In the Carbofuran IRED, EPA concluded that current uses of carbofuran present significant risks to workers and wildlife that are not outweighed by the benefits associated with these uses. In addition, the Agency determined that carbofuran presents human dietary exposures that are not considered safe. EPA proposed immediate cancellation of most uses, a four-year transition period for six crops that have moderate benefits to growers, and retention of tolerances for four imported commodities because associated dietary risk is low. Further information is presented in the Carbofuran IRED fact sheet.

Since EPA issued the Carbofuran IRED, the registrant has submitted studies for Agency review addressing ecological and human dietary risk, as well as other informational documents, including a model to predict the probability that carbofuran uses would cause mortality in birds. Also, EPA's Office of Research and Development has developed additional carbofuran data. The new test data include:

Additionally, the registrant submitted information on the benefits of carbofuran use for corn, melons, potatoes, and sunflowers.

These submissions have resulted in certain refinements to EPA's assessment but do not result in changes to the conclusion that all uses of carbofuran should be canceled.

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Cancellation Process

EPA may cancel a pesticide registration on the Agency's own initiative when the risks associated with use of the pesticide are unacceptable, and the registrants have not made necessary changes to the terms and conditions of registration to address the risks. Because the registrant has not requested voluntary cancellation to address the risks of carbofuran, EPA has initiated the cancellation process under FIFRA section 6(b).

For further information on this process, see Pesticide Cancellation Under EPA's Own Initiative.

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January 2008 Draft NOIC: Risks, Benefits, and Regulatory Response

EPA's carbofuran draft NOIC confirms the risk findings of the 2006 Carbofuran IRED, further explores the benefits of continued use, and makes a risk-benefit determination.

Risks of Concern - Carbofuran poses a significant hazard to exposed persons resulting from its toxicity following acute exposure. Because it is extremely toxic, exposure to even small amounts of carbofuran creates a substantial risk to human health.

Carbofuran also presents risks of concern to terrestrial and aquatic non-target species, especially avian species. Risks to birds are particularly significant and exist for all registered uses of carbofuran. Carbofuran poses a risk of avian death from acute poisoning, as well as significant concerns for the survivial of many avian species.

Benefits - After considering four groups of use sites and registrant-submitted data for several sites, EPA has concluded that most carbofuran uses provide minimal, if any, benefits either to the individual grower or at a national level.

EPA's benefits assessment of carbofuran uses appears on pages 62 to 77 of the draft NOIC document. More detailed benefits analyses are available in the carbofuran docket, EPA-HQ-OPP-2005-0162, in documents number EPA-HQ-OPP-2005-0162-0475 through EPA-HQ-OPP-2005-0162-0481.

EPA's Regulatory Response - Because carbofuran poses significant dietary risks, especially to children, EPA must revoke carbofuran's existing tolerances and cancel the associated food uses.

In addition, carbofuran's occupational and ecological risks substantially exceed EPA's levels of concern. Although carbofuran uses have benefits, none provides sufficient benefits either to individual growers or at the national level to outweigh the substantial combined occupational and ecological risks. EPA has concluded that carbofuran risks outweigh the benefits of continued use. Carbofuran products pose an unreasonable risk to man and the environment and therefore warrant cancellation.

EPA proposes to allow existing stocks of the following carbofuran uses to continue for three years because these uses provide moderate benefits for growers, sufficient pest control alternatives are not available, and the geographic scope of these uses is small:

All other carbofuran uses will be terminated when the cancellation order becomes effective.

EPA also proposes to retain tolerances for the following imported commodities because the associated dietary risk is acceptable:

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