The US EPA has proposed the cancellation of all tolerances for the carbamate insecticide/nematicide, carbofuran, because of concerns that dietary risks exceed safety standards. The unusual move provides “the most direct and timely means to realise protection of children from dietary risks”, the EPA says. It will continue with the planned phase-out of the pesticide following the 2006 determination that all uses were ineligible for re-registration.
Carbofuran registrant FMCfinds the proposal “highly unusual” and “contrary to the EPA’s prior position to maintain imported food tolerances” under the re-registration process. “This action is confusing to growers and consumers and is unwarranted,” says John Cummings, North American regulatory manager of FMC’s agricultural products business. “The EPA did not indicate there was any new information prompting this action,” Mr Cummings notes. “New information developed by FMC and reviewed by [the EPA’s] Scientific Advisory Panel (SAP) in the re-registration review confirmed our position regarding product safety.”
In January, the EPA issued a draft notice of its intent to cancel carbofuran registrations and held a four-day SAP meeting in February to review the science behind its decision. After considering the SAP’s responses and comments from the USDA on the benefits of carbofuran’s continued use, the EPA has determined that cancellation is still warranted.
The Agency is moving to cancel all carbofuran tolerances because aggregate exposure from residues in food and water “substantially exceeds the safe daily levels”, the EPA notes. “It is particularly significant that under every analysis the EPA has conducted, the levels of carbofuran exceed the safe daily dose for children, even when the EPA used the most refined data and models available.”
The most sensitive children’s subpopulations receive unsafe levels of carbofuran from food alone, the Agency concludes. Moreover, adults and children who get their drinking water from vulnerable sources are exposed to residues that exceed the EPA’s level of concern “in some cases by orders of magnitude”.
FMC believes that dietary and aggregate risks from carbofuran are “acceptable when the best available science is used, contrary to the exaggerated risks as reported by the EPA”, Mr Cummings says. “It is our intent to continue to defend our US registration and tolerances.”
The EPA’s finding that aggregate exposure from all uses of carbofuran is unsafe does not necessarily mean that an individual tolerance or group of tolerances could not be maintained, the Agency points out. For example, its interim re-registration eligibility decision concluded that import tolerances for bananas, coffee, rice and sugar cane could continue if domestic uses were cancelled. The EPA invites interested parties to submit information that would allow specific tolerances to be supported. However, such tolerances could only be maintained if cumulative risks from other N-methyl carbamate pesticides were not exceeded. The EPA completed its cumulative risk assessment of this group in 2007.
In May, FMC submitted a conditional request to cancel the use of carbofuran on most crops and suggested use restrictions to mitigate ground and surface water contamination from retained uses. It sought to maintain post-planting applications on maize for corn rootworm (Diabrotica spp) rescue treatments, post-planting applications to potatoes in three states, and use on melons and sunflowers. Use on artichokes, peppers and pine seedlings would be retained during a four-year phase-out.
The cancellation request was conditional on the retention of several uses that do not meet safety standards, the EPA points out. The Agency could not accept such a request and it was subsequently withdrawn. The contribution of the retained tolerances to dietary exposure would have been unsafe for sensitive children’s subpopulations, the EPA notes. Moreover, the proposed use restrictions would not have significantly reduced exposure from drinking water, it adds.