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Carbofuran Cancellation Process
Quick Resources
- Read the Carbofuran RED (PDF) (47 pp, 460k, about PDF)
- Carbofuran Reregistration information
- Carbofuran Reregistration Docket EPA-HQ-OPP-2005-0162
- Pesticide Cancellation Under EPA's Own Initiative
- Revoking Pesticide Tolerances
Current as of March 18, 2009
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.
EPA has concluded that dietary, worker, and ecological risks are of concern for all uses of carbofuran. All products containing carbofuran generally cause unreasonable adverse effects on humans and the environment and do not meet safety standards, and therefore are ineligible for reregistration.
On this page you will find information about the status of the Agency's initiative to obtain cancellation, voluntary or otherwise, of all pesticide products containing carbofuran, and to revoke all U.S. carbofuran tolerances, or legal residue limits in food commodities.
- Voluntary Cancellation of Certain Uses
- Tolerance Revocation - EPA's July 2008 Proposal
- Notice of Intent to Cancel - EPA's January 2008 Draft
Voluntary Cancellation of Certain Uses
Following a public comment period, EPA granted a request from the registrant, FMC Corporation, for voluntary cancellation of certain uses of and products containing flowable and granular carbofuran effective March 18, 2009 [Product Cancellation Order, 3-18-09 FR notice]. All federally registered uses of carbofuran are being cancelled except four food crop uses (field corn, potatoes, pumpkins and sunflowers) and two non-food crop uses (pine seedlings and spinach grown for seed). Use on artichokes will be cancelled after a 2-year phase out period. Certain state Special Local Need registrations are also being cancelled, as requested. Existing stocks of the cancelled products may be used until they are depleted, or until the effective date for revocation of the associated food tolerances.
The Agency is evaluating the remaining carbofuran food uses as part of the process of issuing a final rule with regard to tolerance revocations proposed in July 2008.
Tolerance Revocation
Tolerance Revocation Proposal
In July 2008, EPA initiated action to revoke existing carbofuran tolerances (residue limits in food) due to unacceptable dietary risks, especially to children, from consuming food or water alone or from a combination of food and water with carbofuran residues. [July 31, 2008 FR Notice.] The Agency is nearing completion of its review of comments received on the tolerance revocation proposal and is working on a final tolerance rule that will present the Agency's conclusions regarding the risks of the remaining tolerances, and the Agency's responses to the public comments. Following the tolerance revocations, EPA plans to proceed with cancellation of remaining carbofuran uses due to unreasonable ecological and worker risks.
Due to considerable risks associated with carbofuran in food and drinking water, EPA is revoking the regulations that allow carbofuran residues in food. Because dietary exposures to infants and children are of particular concern, the Agency is moving to revoke carbofuran tolerances first, before cancelling carbofuran registrations. This approach provides the most direct and timely means to realize protection of children from dietary risks. It also allows multiple stakeholders an additional opportunity to comment.
Even though carbofuran is used on a small percentage of the U.S. food supply and therefore the likelihood of exposure through food is low, EPA has identified risks that do not meet our rigorous food safety standards. The Agency is taking the necessary steps to address these risks to ensure we have the safest food supply possible. The U.S. has a safe and abundant food supply, and children and others should continue to eat a variety of foods, as recommended by the federal government and nutritional experts.
Revoking carbofuran tolerances is part of a broader series of Agency actions to cancel all uses of carbofuran in the United States due to human dietary, occupational, and ecological risks of concern. The cancellation process requires the development of several documents, including the tolerance revocation proposal. After moving to revoke carbofuran tolerances, EPA subsequently plans to publish a Notice of Intent to Cancel all carbofuran registrations.
EPA establishes tolerances for pesticides that may be found on foods, and can also revoke tolerances to better safeguard public health and the environment. The Agency must modify or revoke any tolerance that it determines is unsafe, that is, that does not meet the safety standard of the Federal Food, Drug, and Cosmetic Act (FFDCA). The Agency has proposed to revoke all tolerances for carbofuran because exposure through food and drinking water does not meet the FFDCA section 408 (b)(2) safety standard. For further information on this process, see Revoking Pesticide Tolerances.
Notice of Intent to Cancel (NOIC)
SAP and USDA Review of Draft NOIC
EPA also is proceeding on the path toward cancellation of carbofuran registrations, which will address risks to pesticide applicators and risk to birds in treated fields. In 2006, in addition to dietary risks, EPA identified significant occupational and ecological risks from the use of carbofuran. 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 concluded that carbofuran products pose an unreasonable risk to man and the environment which outweighs the benefits of continued use, and therefore all uses must be cancelled.
In January 2008, EPA submitted for FIFRA Scientific Advisory Panel (SAP) and USDA review a draft Notice of Intent to Cancel (NOIC) carbofuran pursuant to section 25(d) of FIFRA. After considering the SAP's responses and USDA's comments, EPA has determined that cancellation is still warranted. The Agency's responses to the SAP and USDA are available in the carbofuran dockets. EPA plans to issue a final carbofuran NOIC after taking steps to revoke the tolerances.
EPA's regulatory actions are part of the Agency's pesticide reregistration and tolerance reassessment programs. By law, the Agency was required to reassess by August 2006 all tolerances that were in existence as of August 2, 1996. In August 2006, EPA published its Carbofuran Interim Reregistration Eligibility Decision (IRED) (PDF) (44 pp, 392k, about PDF) concluding that no carbofuran uses met the statutory standards, and therefore no uses were eligible for reregistration. The Agency intended to cancel all uses of carbofuran due to ecological and occupational risks of concern, as well as dietary risks from residues on food crops and in contaminated drinking water.
After EPA issued the IRED, the carbofuran registrants submitted for Agency review a number of studies addressing ecological and human dietary risk, as well as other informational documents. EPA reviewed all submitted data and documents, as well as additional data developed by the Agency's Office of Research and Development. While these submissions resulted in certain refinements to the Agency's assessment, EPA continues to believe that all uses of carbofuran should be canceled for the reasons identified above.
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 unacceptable risks. Because the registrant's voluntary cancellation of a number of carbofuran uses and registrations, effective March 18, 2009, does not address all carbofuran risks, EPA plans to proceed to address the risks from the remaining uses. EPA plans to continue to first resolve the remaining dietary risks through the tolerance revocation process under section 408 of the FFDCA. Once the dietary issues have been resolved, EPA will proceed to address the remaining worker and ecological risks from any remaining uses through the cancellation process under FIFRA section 6(b). For further information on this process, see Pesticide Cancellation Under EPA's Own Initiative.