DC Circuit Court Upholds Denial of Hearing to Challenge Carbofuran Tolerance Revocation

Client Advisory

On July 23, the U.S. Court of Appeals for the DC Circuit rejected FMC’s attempt to overturn EPA’s denial of a hearing to challenge the revocation of the tolerances for carbofuran.  The Court did reverse the revocation of the import tolerances.

The Agency had found that carbofuran presented an unacceptable risk resulting from both food and water exposure.  Rather than seeking to cancel the uses of carbofuran, the Agency instead determined that it would revoke the domestic and import tolerances for carbofuran.  In the absence of a tolerance, food containing carbofuran could not travel in interstate commerce, thus in effect canceling the registration without formally doing so.

As you likely are aware, tolerances are established under the Federal Food, Drug and Cosmetic Act (“FFDCA”).   A tolerance is actually a rule, so a revocation involves the repeal of a rule.  To do so, EPA must first propose the revocation and offer a comment period.  If the revocation is finalized, there is then an opportunity for opponents to file objections and request a hearing.  The FFDCA gives the Administrator wide discretion in deciding whether to hold a hearing on a proposed tolerance revocation. 

In this instance EPA asserted that FMC had not proposed to present any new information and thus there was no reason to hold a hearing. The Court upheld this position, ruling that if data and arguments opposing revocation are not presented at the comment stage, such information or arguments cannot be used at the objection stage to support a demand for a hearing.   An example of the data FMC sought to present at the objection stage was information on the percentage of crop treated (“PCT”).  EPA had assumed 100% PCT, while FMC argued that it had county-level data showing a maximum PCT of 4.25.  EPA rejected the data, claiming that it was not detailed enough to support a determination that a lower PCT could be used in the risk assessment with assurance that there would be no small watersheds where the PCT could spike much higher, leading to the a greater likelihood of carbofuran presence in water.  

In a statement to CropLife America, counsel for FMC has expressed surprise at the Court’s upholding of EPA’s standard for granting a hearing, noting that the Court took no notice of the fact that EPA shifted its position as the revocation proceeded, necessitating the submission of additional information.  The options at this point are to seek a rehearing or file a Petition for Certiorari with the Supreme Court.

The Court very pointedly directed EPA to reverse the revocation of the import tolerances in light of the fact that EPA had determined that the risk from imported food alone was acceptable.  In dismissing EPA’s defenses of the import tolerance revocation, the Court stated that “rejection of [EPA’s position] requires no display of learning.”

If this decision stands, EPA will have available an alternative avenue for eliminating use of an agricultural pesticide that avoids the formalities of a FIFRA Section 6 cancellation hearing.  Given the wide leeway that the Agency will now be afforded, any party seeking to secure a hearing to challenge a tolerance revocation will face significant procedural and substantive hurdles.

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Questions regarding this advisory should be addressed to Telisport W. Putsavage (202-623-5704, putsavage@clm.com).

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Carter Ledyard & Milburn LLP uses Client Advisories to inform clients and other interested parties of noteworthy issues, decisions and legislation which may affect them or their businesses. A Client Advisory does not constitute legal advice or an opinion. This document was not intended or written to be used, and cannot be used, for the purpose of (i) avoiding penalties under the Internal Revenue Code or (ii) promoting, marketing or recommending to another party any transaction or matter addressed herein. © 2012 Carter Ledyard & Milburn LLP.
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