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Carbofuran Cancellation Process

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Current as of July 31, 2008

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.

Tolerance Revocation

Tolerance Revocation Proposal

Public comments on EPA's carbofuran tolerance revocation proposal are due to EPA by September 29, 2008 - July 31, 2008 FR Notice. How to submit comments.

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.

In a Federal Register notice published on July 31, 2008, EPA is proposing to revoke all U.S. carbofuran tolerances. The Agency specifically is requesting comment on whether any individual carbofuran tolerances, or group of tolerances, meet the Federal Food, Drug, and Cosmetic Act safety standard. It is possible that one or more individual carbofuran tolerances could be maintained, if information is provided to demonstrate that the tolerance(s) would be safe.

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 this proposed tolerance revocation. 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 is proposing 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.

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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 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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How to Submit Comments

July 31, 2008, FR Notice - Comments will be accepted on EPA's carbofuran tolerance revocation proposal until September 29, 2008. All comments should be identified by Docket ID number EPA-HQ-OPP-2005-0162.

Publicly available docket materials are available either in the electronic docket at Regulations.gov, or in hard copy at the Office of Pesticide Programs (OPP) Regulatory Public Docket.

Comments may be submitted by one of the following methods:

Please do not e-mail or fax your comments. For questions or assistance, contact the OPP Regulatory Public Docket at (703) 305-5805.

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