May 14, 2009
FMC Corp. officials said they strongly disagree with and will file objections to EPA’s decision to revoke all U.S. food tolerances for carbofuran, the active ingredient in the company’s Furadan pesticide.
FMC’s stance is unusual in that most pesticide registrants generally accede to EPA rather than risk a prolonged legal battle with little, if any, assurance, they can bring about a change in the agency’s decision-making.
“We are very disappointed by the EPA revocation and their unwillingness to recognize that our voluntary changes to the label allowed the product to meet the dietary safety standard using EPA’s own conservative assumptions,” said Michael Morelli, director of global regulatory affairs, FMC Agricultural Products Group.
“President Obama has committed EPA to regulating on the basis of sound science, and FMC is confident that a fair hearing based on sound scientific principles will prove carbofuran's safety to the satisfaction of all."
Morelli said FMC believes EPA’s action to be highly unusual and contrary to EPA’s past position, which would have maintained at least imported food tolerances for the product. Since EPA announced its intention to cancel carbofuran registrations in 2006, FMC has modified the product label and generated additional data, all of which confirm the safety of this product.
CropLife America, the organization which represents many of the nation’s pesticide manufacturers and distributors, issued a press release questioning EPA’s May 11 announcement and its impact on the regulatory climate.
“While our individual members compete with many specific products in the marketplace and our association does not take a position on any single product, CropLife America has consistently supported a clear and transparent process for the regulation of all pesticide products,” said Jay Vroom, CLA president and CEO.
“EPA’s announcement that it will proceed with revocation of carbofuran tolerances before resolving the U.S. registered label uses of the product is completely out of phase with traditional regulatory process.”
Vroom said the new regulatory strategy being followed by EPA was initiated during the Bush administration, “to our dismay,” and the industry was hopeful the new Obama administration would put regular order back to work.
“Instead, it has chosen to extend the incorrect path it inherited. Given the publicized commitment by newly appointed EPA leadership to sound science, transparency, and the rule of law, we are even more perplexed by this announcement,” said Vroom. “In many respects, the decision to revoke carbofuran's tolerances does not live up to that commitment.”
EPA’s old registration and cancellation procedure was intended to be used to resolve issues of this nature, but EPA’s use of the tolerance revocation procedure to regulate carbofuran effectively shuts out of the pesticide decision making process those who arguably have the most critical agricultural interests, such as growers and USDA.
Vroom says CLA is concerned with this process departure since it may increase the possibility of farm produce inadvertently violating pesticide residue allowances — putting US farmers at an unnecessary risk for liability.
“The EPA’s action has the potential of creating a new and unwise regulatory precedent. CLA believes that it is critically important that the issues concerning carbofuran ultimately be resolved on the basis of sound scientific principles,” he said. “We strongly encourage further consideration by the administration.”
Morelli agrees EPA’s action is confusing to growers and others in the agricultural community as it circumvents the normal re-registration process under the Federal Insecticide, Fungicide and Rodenticide Act.
EPA has taken no action to cancel carbofuran’s registrations, which continue under FIFRA. Several major grower associations, USDA and all 50 secretaries of state Departments of Agriculture have gone on record supporting the continued, but very limited use of carbofuran where there are no alternative products, such as in sunflowers and corn rootworm rescue.
Under the EPA action, FMC can still sell and growers can use carbofuran until Dec. 31. The company will follow all available administrative procedures and hopes to have the product available for the next crop growing year.
In another development, EPA has updated its benefits assessments of endosulfan for potato, cotton, apples, tomatoes, cucumber, melons, pumpkin and squash and said it finds that the loss of pesticide will be minimal to cotton. The Agency is requesting public comments on the finding by July 6.
This action is in response to a Feb. 19, 2008 petition filed by the National Resources Defense Council and the Pesticide Action Network North America. The petition requested EPA cancel all registrations and revoke all tolerances for endosulfan, claiming endosulfan “harms the hormone system, and low levels of exposure in the womb have been linked to male reproductive harm, other birth defects and possibly autism.”
EPA’s Biological and Economic Analysis Division considered two strategies to mitigate worker exposure to endosulfan — elimination of aerial applications and extension of the Restricted Entry Interval to address, respectively, concerns for workers: 1) who mix, load and apply endosulfan and 2) who conduct various field activities following an application of endosulfan.
According to BEAD, both strategies could make the use of endosulfan impracticable for growers. As a result, growers are likely to switch to alternatives.
According to the National Cotton Council, endosulfan currently has a relatively minor overall role in cotton pest management nationwide, but is used on about 25 percent of the cotton acreage in Arizona and 9 percent in California, where high-value long staple cotton is produced. Effective alternatives from several chemical classes exist for control of the lygus bug and whitefly on cotton in Arizona and California. Endosulfan’s most important niche is in Arizona where it is used in rotation with acephate, oxamyl, and flonicamid for Lygus bug resistance management.
BEAD believes that endosulfan’s current role in resistance management is minimal and that the loss of endosulfan will not result in adverse resistance management outcomes. Given endosulfan use patterns, its target pests, effectiveness of its alternatives and the cost of its alternatives, BEAD concludes that there will be minimal impact on cotton producers that are not likely to exceed 1 percent of net operating revenue if endosulfan is not available.
Comments on EPA Impact Assessments on Endosulfan; Request for Comments and Additional Information on Importance of Use should be identified by Docket No. EPA-HQ-OPP-2002-0262 and submitted by July 6 to http://www.regulations.gov.
EPA has also revised certain provisions of the 2006 Re-Registration Eligibility Decision (RED) for the organic arsenical pesticides — which include MSMA.
In the 2006 RED, EPA concluded that all uses of the inorganic arsenicals were ineligible for re-registration primarily because of risks to drinking water resources. Additional data received since 2006 supported a decision to allow re-registration of MSMA for use on cotton only, contingent on the development of confirmatory data.
In February, EPA reached an agreement in principle with the registrants which, over time, removes from the market all organic arsenical pesticide uses, except the use of MSMA on cotton, for which confirmatory data must be received by Aug. 2010. The agreement also implements new restrictions to protect drinking water resources. For more information, see the Federal Register notice announcing these revisions is at http://www.epa.gov/fedrgstr/EPA-PEST/2009/May/Day-06/p10330.htm.
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