Registration in the United States
Carbofuran was first registered in the United States in 1969. Today, carbofuran (Furadan) is registered in the United States for use on corn, pine seedlings, potatoes, pumpkins, spinach grown for seed, and sunflowers. However, there are no tolerances for these U.S. crops, so Furadan is not currently available for purchase from FMC in the United States. In 1991, the U.S. Environmental Protection Agency (EPA) and FMC agreed to phase down and limit the use of granular formulations (2,500 lbs. active ingredient annually) to minimize risk to birds. There have been no confirmed reports of bird mortality from labeled uses of carbofuran since 2000.
The EPA continues to evaluate the re-registration eligibility of carbofuran, although the Agency has revoked all domstic tolerances.
- (September 2007) The EPA determined that all uses of carbofuran do not meet the standard for continued registration due to ecological and occupational risks of concern and dietary risks of concern from some crops. However, the Agency noted that import tolerances for bananas, coffee, rice, and sugarcane met the standard for acceptable dietary risk. Also, a four year phase out period was decided upon for several uses. These uses do not pose dietary risks of concern and do have benefits to growers.
- (January 2008) The EPA issued a draft Notice of Intent to Cancel All Registrations for Pesticide Products Containing Carbofuran. The EPA is currently evaluating scientific and benefits comments from FMC, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel, and the U.S. Department of Agriculture (USDA)
- (July 2008) The EPA proposes to revoke all carbofuran crop tolerances. The EPA is evaluated scientific comments from FMC, as well as several commodity and trade organizations, demonstrating that a group of crop tolerances meets the safety standard.
- (March 2009) FMC's voluntary cancellation of most carbofuran uses is approved by the EPA. The remaining registered uses are corn, pine seedlings, potatoes, pumpkins, spinach grown for seed, and sunflowers.
- (May 2009) EPA published a final tolerance revocation; all crop tolerances including import tolerances are revoked as of December 31, 2009.
- (June 2009) FMC filed objections and requested an administrative hearing to challenge EPA’s decision to revoke all carbofuran tolerances. FMC will look to an administrative law judge to evaluate the merits of the science. It is FMC’s position that carbofuran has acceptable dietary risk even using EPA’s own ultra-conservative assumptions such as a 400-fold safety factor and taking into account all sources of drinking water exposure.
- (November 2009) FMC and three national growers groups filed a petition with the D.C. Circuit Court of Appeals challenging EPA's action to deny an Administrative Hearing.
- (December 2009) The D.C. Circuit Court of Appeals denied a request for a stay, granted our request for expedited review, and granted the request of CropLife America and others to file amicus briefs. Both the EPA and FMC filed briefs and the court heard oral arguments on Monday, March 22.
- (July 2010) The U.S. Court of Appeals for the D.C. Circuit ordered the EPA to reinstate import tolerances for carbofuran for rice, bananas, coffee and sugar cane. Although the court did not endorse EPA's views on the safety of carbofuran, for procedural reasons it did not overturn the agency's decision to deny an administrative hearing regarding revocation of domestic tolerances.
- (December 2010) The U.S. Supreme Court approved FMC’s request for an extension to file a petition for the court to review our case for having EPA grant a hearing.
- (July 2009) The Pest Management Regulatory Agency (PMRA) issues the draft Proposed Re-evaluation Decision (PRVD) for Carbofuran for public comment. The preliminary decision is to phase out all carbofuran product registrations and amend or revoke all maximum residue limits (MRLs).
- (October 2009) FMC submits comments to PMRA recommending revisions to the preliminary risk assessments which, if incorporated into the assessments, result in acceptable levels of risk for the registered uses.
- (January 2010) FMC provides additional studies and U.S. EPA reviews to PMRA to supplement comments provided in October 2009.
- (February 2010) FMC responds to PMRA request for use patterns support and mitigation measures with request for meeting to discuss mitigation.
- (July 2010) PMRA informs FMC that they have not changed their conclusions in the July 2009 Proposed Re-evaluation Decision.
- (October 2010) FMC meets with PMRA on Re-evaluation Decision and requests revised risk assessments supporting regulatory decision.
- (December 2010) PMRA publishes Re-evaluation Decision to phase out all carbofuran product registrations.
(January 2011) FMC considers options for objecting to PMRA regulatory decision and to work with PMRA on timing for relevant product phase outs.
Registration in the European Union
On July 13, 2007, the European Commission issued its decision not to include carbofuran in Annex I to Directive 91/414/EEC. A number of concerns had been identified late in the review process and consequently certain risk assessments could not be concluded. FMC had submitted the additional data two years before the decision, but these were not reviewed because they were submitted after the legal deadline.
The Commission stated that the decision did not prejudice the submission of a new application for registration.