Susan Biroe, a chief ALJ with the EPA, said Bayer and fellow registrant Nichino America accepted the terms of EPA’s 2008 conditional registration, which required the companies to voluntarily cancel their registrations if EPA concluded that found the pesticide would have “unreasonable adverse effects on the environment.”
EPA’s Environmental Fate and Effects Division concluded last year that “significant effects to aquatic organisms due to the use of flubendiamide could potentially occur in as little as two years” and asked Belt and Nichino to submit voluntary cancellations of their registrations. The companies declined, setting up the administrative challenge, which now goes to EPA’s Environmental Appeals Board, which has until July 6 to decide the matter.
Bayer contended that EPA shifted the goalposts significantly by deriving a toxicity endpoint for flubendiamide’s degradate, des-iodo, from a water study, not a sediment study. The sediment study had found “no observable adverse effects of the des-iodo to benthic aquatic invertebrates at any level tested,” leading to a toxicity endpoint of 19.5 parts per billion, but the water study resulted in a toxicity endpoint of .28 ppb, Biro said in her decision.
“A toxicity endpoint is a numerical value that establishes a threshold level of a compound below which adverse effects are not seen,” the judge explained in a footnote.
Late last year, Bayer complained to Jim Jones, Assistant Administrator for the Office of Chemical Safety and Pollution Prevention, about the “sudden change in approach.” EPA “acknowledged the timing of its shift was unfortunate but necessary due to internal agency dynamics,” the judge said.
Bayer called the judge’s decision “disappointing for supporters of science-based regulations and grower choice,” but the company said it was not unexpected, given the judge’s prior preliminary rulings. The company specifically referenced her decision to exclude discussion on scientific issues raised by EPA actions. While disappointed, the company pledged to continue fighting the ruling.
“This is only one step in our appeal process and we look forward to having a careful review when (Biro’s) decision and (her) 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,” the company said in a prepared statement.
Biro also upheld the agency’s decision not to allow sales of products containing flubendiamide.
EPA “took a leap of faith” when it conditionally approved the registration for flubendiamide, the judge said, which benefited both Bayer and Nichino. EPA “could have simply denied the application based on then-existing data that suggested environmental risk.”
The companies “are intentionally out of compliance, and have no intention of coming into compliance,” Biro said. “There is no reason to allow them to continue to sell and distribute their pesticides beyond the effective date of cancellation…. I agree with (EPA) that its positive view of the conditional registration program, and potentially compliance therewith, would collapse if the agency were forced to allow sale of existing stocks even by those registrants who refuse to comply with the terms of their registration.”
Numerous grower groups and CropLife America filed amicus briefs in support of Bayer and Nichino. The Center for Biological Diversity filed a brief in support of the notice of intent to cancel the registrations.
View a copy of the Notice of Intent to Cancel and all supporting documents:
- Flubendiamide – Notice of Intent to Cancel (PDF)(4 pp, 204 K, March 4, 2016)
- Decision Memo regarding findings and conclusion on environmental impacts of flubendiamide (PDF)(11 pp, 2 MB, January 29, 2016)
- Letter from EPA to Bayer CropScience LP requesting voluntary cancellation of flubendiamide products (PDF)(2 pp, 1 MB, January 29, 2016)
- Letter from Bayer CropScience LP to EPA declining request for voluntary cancellation of flubendiamide products (PDF)(3 pp, 79 K, February 5, 2016)
- Preliminary Acceptance Letter describing the terms and conditions for registration of flubendiamide (PDF)(4 pp, 483 K, July 31, 2008)
- Ecological Risk Assessment Addendum Summarizing all Submissions to Date for flubendiamide (PDF)(52 pp, 1 MB, January 28, 2016)
- Review of 3 Years of Water Monitoring Reports for flubendiamide (PDF)(25 pp, 642 K, February 20, 2015)
- Addendum to Clarify Invertebrate Terminology for flubendiamide (PDF)(5 pp, 501 K, January 29, 2016)
- Benefits Review for flubendiamide (PDF)(8 pp, 883 K, July 28, 2015)
- Ecological Risk Assessment for flubendiamide (PDF)(90 pp, 4 MB, December 16, 2010)
- Ecological Risk Assessment for flubendiamide (PDF)(167 pp, 8 MB, May 17, 2010)
- Ecological Risk Assessment for flubendiamide (PDF)(133 pp, 6 MB, June 23, 2008)