On January 26, 2012, the Natural Resources Defense Council (NRDC) sued the U.S. Environmental Protection Agency (EPA) for approving a pesticide product containing nanosilver under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). This article summarizes the lawsuit, explains what’s at stake, and discusses the lawsuit’s implications.
HeiQ, a company headquartered in Bad Zurzach, Switzerland, filed an application in 2008 for HeiQ AGS-20, a materials preservative in textiles. After considerable administrative review and an EPA Scientific Advisory Panel (SAP) review, EPA proposed to approve the registration conditionally and requested comment on its proposal. Importantly, as part of the conditional approval, EPA would require that HeiQ conduct certain studies during a 4-year period following issuance of the conditional registration. The required tests include route-specific toxicity studies for occupational exposure scenarios, as well as product characterization and stability tests to determine if nanosilver breaks away from AGS-20.
NRDC objected to the registration, and contended that HeiQ should produce the data before commercializing the product, not while it’s selling the product. EPA considered all public comments and ultimately disagreed with NRDC. EPA noted that because it hadn’t reached a final decision with regard to the types of data that would be required, HeiQ didn’t have a reasonable period of time within which to generate and submit the data to EPA. EPA concluded the absence of data didn’t undermine its conclusion that marketing the nanopesticide product posed no unreasonable adverse health or environmental effects.
On December 1, 2011, EPA granted conditional approval of HeiQ AGS-20.
NRDC used FIFRA Section 16(b) to challenge EPA’s actions. This provision allows “any person” who claims to be adversely affected by an EPA order issued after a “public hearing” to obtain judicial review “praying that the order be set aside in whole or in part.” Although no “public hearing” took place in connection with the HeiQ registration application, legal decisions have constructed Section 16 broadly.
The courts interpret the phrase “public hearing” to include administrative proceedings that have resulted in a well-developed factual record. In the HeiQ case, the record is extensive and includes the original and revised registration application, the proceedings of the SAP, all data submitted in support of the registration, the extensive public comment, EPA’s response to comment document, and related documents. In short, the record appears to fall well within the scope of FIFRA Section 16(b)’s judicial review providing the court with jurisdiction to hear the case.
The court now must determine whether EPA’s decision to grant the registration was consistent with the safety standard set out under FIFRA or if EPA violated FIFRA, as NRDC contends, by allowing the product on the market before submittal of the data required for registration. Regardless of whether NRDC prevails, the challenge to the registration has important far-reaching implications.
First, it’s likely to cause additional commercial uncertainty both for HeiQ and the nanopesticide community, and perhaps the nano community at large. Here, the record is robust as EPA carefully reviewed the registration application and engaged in extensive deliberations over a period of years. With this in mind, EPA has reason to be confident that the record will survive judicial scrutiny.
Second, to some extent, EPA’s review of new technology as it relates to pesticide active ingredients would appear to be on trial here. The court could determine, for example, that due to the nature of the technology and certain inherent deficiencies in the state of the science related to nanopesticides, EPA’s review insufficiently protected human health and the environment and the record is inadequate for purposes of demonstrating the safety standard under FIFRA.
Third, the case demonstrates that third parties have considerable leverage in pesticide registration cases simply by filing a petition for review in federal appellate court given the generous interpretation of the “public hearing” provision in FIFRA Section 16(b). Virtually any controversial pesticide decision on which EPA seeks public comment is amenable to challenge provided EPA has developed a sufficiently robust record for the court of appeals to review.
Nano stakeholders are urged to monitor this case carefully and intervene or file “friends of the court” briefs as appropriate. The case is one of first impressions and, therefore, is important to get right.
LYNN BERGESON is Chemical Processing's Regulatory Editor. You can e-mail her at firstname.lastname@example.org.
Lynn is managing director of Bergeson & Campbell, P.C., a Washington, D.C.-based law firm that concentrates on chemical industry issues. The views expressed herein are solely those of the author.