Carbofuran Cancellation Process
Current as of June 2011
Carbofuran is an N-methyl carbamate insecticide and nematicide that has been 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 unacceptable 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 - EPA's revocation of carbofuran tolerances became effective on December 31, 2009
- Voluntary Cancellation of Certain Uses - March 2009
- Notice of Intent to Cancel - EPA's January 2008 Draft
Tolerance Revocation Rule
- Carbofuran Order Denying FMC's Objections and Requests for Hearing; Final Rule (November 18, 2009)
- Press Release
- Carbofuran; Final Tolerance Revocations (May 15, 2009)
- Notification to World Trade Organization (May 21, 2009) (3 pp, 55k, about PDF)
- Carbofuran; Proposed Tolerance Revocations (July 31, 2008)
Under the Agency's May 15, 2009 final rule, EPA's revocation of carbofuran tolerances became effective on December 31, 2009. EPA continues to find that dietary exposures to carbofuran from all sources combined are not safe.
EPA encourages growers to switch from carbofuran to safer pesticides or other environmentally preferable pest control strategies. Since the tolerances are revoked, EPA reminds growers that carbofuran should not have been used on any food crops since December 31, 2009. Use of carbofuran after this date would result in adulterated food products, which would be subject to appropriate enforcement by the Food and Drug Administration. 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.
After requesting and considering public comment, in May 2009, EPA revoked carbofuran tolerances, the regulations that allow carbofuran residues in food, effective December 31, 2009, due to considerable risks associated with this pesticide in food and drinking water. Carbofuran; Final Tolerance Revocations - Final Rule May 15, 2009. During the objection period, the carbofuran registrant, FMC Corporation, and three grower associations (corn, sunflowers and potatoes) submitted objections to EPA’s tolerance revocations and requested an administrative hearing. EPA concluded in October 2009 that the regulatory standard for holding an evidentiary hearing had not been met. EPA’s detailed explanation about why a hearing was not warranted, and the reasons for denying the objections are included in Carbofuran; Order Denying FMC's Objections and Requests for Hearing - November 18, 2009.
FMC in conjunction with the three grower associations filed a challenge to EPA’s decision with the U.S. Federal Court of Appeals, which was heard in March 2010. The ruling handed down in July 2010 upheld EPA’s revocation of all carbofuran domestic tolerances and denial of the hearing requests, but vacated EPA’s revocation of the four import tolerances (for bananas, coffee, rice and sugarcane). In October 2010, the DC Circuit Court of Appeals denied a September 2010 petition filed by FMC and the three grower organizations for a carbofuran rehearing and rehearing en banc. The petitioners appealed this decision to the Supreme Court. On May 31, 2011, the Supreme Court declined to hear the request by FMC and the three grower associations to review EPA's 2009 decision to revoke all domestic tolerances for carbofuran, ending these legal challenges.
EPA’s May 2009 action to revoke all carbofuran tolerances effective December 31, 2009, was the culmination of a regulatory process that began in 2006 when the Agency published its risk assessments for carbofuran and determined, in August 2006, that no uses were eligible for reregistration. Although FMC voluntarily canceled 22 carbofuran uses in March 2009, the elimination of these uses was not sufficient to allow the Agency to make a finding that combined dietary exposures to carbofuran from food and water are safe. The process to cancel the remaining carbofuran registrations is underway and will address risks to pesticide applicators and birds in treated fields.
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 revoked all tolerances for carbofuran because exposure through food and drinking water combined does not meet the FFDCA section 408 (b)(2) safety standard. For further information on this process, see Revoking Pesticide Tolerances.
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 have been canceled except four food crop uses (field corn, potatoes, pumpkins and sunflowers) and two non-food crop uses (pine seedlings and spinach grown for seed). Certain state Special Local Need registrations are also being canceled, as requested. Existing stocks of the canceled products could be used until depleted, until December 31, 2009, the effective date for revocation of the associated food tolerances. Carbofuran products labeled for non-food uses (pine seedlings, spinach grown for seed) and voluntarily cancelled non-food use (ornamentals) may continue to be used in accordance with label directions, including geographical restrictions.
EPA plans to proceed with cancellation of any remaining carbofuran uses due to unreasonable ecological and worker risks.
SAP and USDA Review of Draft NOIC
EPA also is proceeding on the path toward cancellation of the remaining 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 canceled.
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 once all legal challenges are settled.
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. The registrant's voluntary cancellation of a number of carbofuran uses and registrations, effective March 18, 2009, does not address all carbofuran risks. EPA therefore plans to proceed to address the worker and ecological risks from the remaining uses of carbofuran through the cancellation process under FIFRA section 6(b), after resolving dietary risks through the tolerance revocation process under section 408 of the FFDCA. For further information on this process, see Pesticide Cancellation Under EPA's Own Initiative.