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Daily News Blog

06
Jun

EPA Judge Rejects Bayer’s Challenge to Keep Flubendiamide on Market after Agency Pulls Conditional Registration

(Beyond Pesticides, June 6, 2016) Bayer CropScience’s appeal of the cancellation of their toxic pesticide flubendiamide by the U.S. Environmental Protection Agency (EPA) was rejected by EPA’s Chief Administrative Law Judge (ALJ) Susan Biro on Thursday, June 1. Judge Biro dismissed the complaints, saying that the agency was acting within its authority when it pulled its approval for the pesticide earlier this year after the two manufacturers, Bayer CropScience and Nichino America, failed to meet the terms laid out in a 2008 conditional registration. A startling number of pesticides, nearly 65% of the more than 16,000 pesticides now on the market, were first approved by the process of “conditional registration,” a loophole in which EPA allows new pesticides on the market without the full range of legally mandated toxicity tests for a full registration. Meanwhile, the Canadian Pest Management Regulatory Agency finalized its  decision to discontinue granting new conditional registrations, also on June 1.

bayerlogoIn 2008, EPA granted Bayer a “conditional” registration for flubendiamide, a classification that allows a new pesticide to be registered and used in the field, despite outstanding data points on its toxicological impact. In this case, original data submitted to EPA by Bayer showed concern over the effect of the chemical and its breakdown product on freshwater benthic invertebrates, species such as crustaceans and aquatic insects that  live in stream sediment and provide important ecosystem services such as decomposition and nutrient cycling. In response, rather than declining to proceed with registration of the chemical, EPA negotiated a deal with Bayer to conditionally register the chemical for five  years with additional label restrictions, while it waited for more  data on the harm to benthic species.

The agency issued a Notice of Intent to Cancel (NOIC) the insecticide on March 4, finding that the company failed to comply with its conditional pesticide registration, backing EPA’s novel process to quickly cancel pesticides and upholding EPA’s ban on sales of existing flubendiamide stocks. The judge found that the agency’s actions in relation to the pesticide have all been consistent with the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).

As part of the additional data requirements, EPA requested a study to investigate the utility of 15 foot buffer zones (part of the new label requirements EPA assumed would mitigate hazards to benthic organisms). In a novel move, EPA’s agreement with Bayer indicated that the pesticide’s conditional registration would expire in 2013, and if additional data revealed “unreasonable adverse effects,” it would notify the  company, which would then voluntarily withdraw the chemical from the market.

Judge Biro says the agency’s arguments were essentially “unopposed” in the case, calling Bayer’s arguments untimely and unconvincing. “Petitioners do not dispute that after reviewing the data, EPA made a determination, as evidenced by its January 29, 2016 letter to them that further registration of the flubendiamide products ‘will result in unreasonable adverse effects on the environment.’”

A Bayer spokesman, in a statement to Inside EPA, said that the order is “disappointing for supporters of science-based regulations and grower choice, but it was not unexpected, given the Judge’s prior preliminary rulings, including her decision to exclude any discussion of the scientific issues raised by EPA’s actions on flubendiamide.”

However, since its conditional registration, studies showed that flubendiamide —which is registered for use on over 200 crops, including soybeans, almonds, tobacco, peanuts, and cotton— is toxic to aquatic organisms, breaking down into a more highly toxic substance that harms organisms important to aquatic ecosystems, especially fish. The insecticide is also persistent in the environment. According to EPA, after being informed of the agency’s findings on January 29, 2016, the manufacturers, Bayer CropScience, LP and Nichino America, Inc., were asked to submit a request for voluntary cancellation by Friday, February 5, 2016.  Bayer has rejected the request and EPA’s interpretation of the science.

But, Judge Biro in her June 1 order faulted that argument as unpersuasive, saying the conditional registration did not require EPA to pursue such a dialogue, yet evidence suggests that “EPA’s scientists did engage in a good faith dialogue.”

“The Petitioners here are intentionally out of compliance, and have no intention of coming into compliance,” Judge Biro stated. “There is no reason to allow them to continue to sell and distribute their pesticides beyond the effective date of cancellation.”

Yet, Bayer says that they will continue with the appeal process: “We look forward to having a careful review when the Initial Decision and the ALJ’s prior preliminary rulings are taken up by the Environmental Appeals Board, which is scheduled to issue the final EPA decision no later than July 6.”

This incident shows that even when conditional registration data is submitted and adequately reviewed, EPA is challenged in its  effective execute of the statutory obligation to prevent unreasonable adverse effects to people and  the environment. In 2013, the Government Accountability Office scolded the agency for its conditional registration process, writing, “Specifically, EPA does not have a reliable system, such as an automated data system, to track key information related to conditional registrations, including whether companies have submitted additional data within required time frames.” A significant issue related to this problem was the handling of the conditional registration for another of Bayer’s products, neonicotinoid pesticides. Despite data showing adverse effects to honey bees, and a leaked EPA analysis indicating a field study provided by Bayer was inadequate, the agency provided the chemical clothianidin with a conditional registration. EPA later reversed its stance on the field study and provided clothianidin with a full registration after it indicated that it was able to generate enough data by combining the defunct field study with other proprietary studies Bayer conducted. Now, as part of a review of another neonicotinoid, imidacloprid, EPA is finally confirming that these chemicals harm pollinators.

Given these problems and the difficulties of removing harmful pesticides from the market, a more prudent approach to protecting environmental health would be to halt the use of conditional registrations, as the Canadian Pest Management Regulatory Agency recently decided to do, which was also finalized June 1. Rather than provide avenues for chemical companies to game the system and poison the environment, advocates maintain that EPA should take strong action to encourage pest prevention and readily available alternatives to toxic pesticides.

Beyond Pesticides has long advocated a regulatory approach  that prohibits hazardous chemical use and requires alternative assessments to identify less toxic practices and products under the unreasonable adverse effects clause of FIFRA. Farm, beekeeper, and environmental groups, including Beyond Pesticides, have urged EPA to follow in the steps of countries like Canada and the European Union by following the precautionary principle, which generally approves products after they have been assessed for harm, not before. Beyond Pesticides  suggests an approach that rejects uses and exposures deemed acceptable under risk assessment calculations, and instead focuses on  safer alternatives that are proven effective, such as  organic agriculture, which prohibits the use of toxic chemicals.

All unattributed positions and opinions in this piece are those of Beyond Pesticides.

Source: Inside EPA

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