Conditional registration status is acceptable under section 136a(c)(7)(C) of FIFRA (7 U.S.C. §§ 136-136y), which states:
“The Administrator may conditionally register a pesticide containing an active ingredient not contained in any currently registered pesticide for a period reasonably sufficient for the generation and submission of required data (which are lacking because a period reasonably sufficient for generation of the data has not elapsed since the Administrator first imposed the data requirement) on the condition that by the end of such period the Administrator receives such data and the data do not meet or exceed risk criteria enumerated in regulations issued under this subchapter, and on such other conditions as the Administrator may prescribe. A conditional registration under this subparagraph shall be granted only if the Administrator determines that use of the pesticide during such period will not cause any unreasonable adverse effect on the environment, and that use of the pesticide is in the public interest.”
For insight in interpreting this section of FIFRA, the court looked to the legislative history of the statute. The court noted that congressional testimony consistently discussed how conditional registration would be saved for “truly exceptional cases” and that “a more stringent test” would need to be met to meet the public-interest requirement. The court held that Nanosilva’s “potential” to be in the public interest failed to pass this “more stringent test."
In considering the EPA’s public-interest finding, the court analyzed three premises disputed by the Petitioners that underlie the EPA’s finding that Nanosilva had the potential to reduce the amount of silver released into the environment:
1. Nanosilva’s lower application rate (i.e., it uses less silver)
- The court found that the EPA presented substantial evidence to support its findings regarding Nanosilva’s toxicity profile. In doing so, the court deferred to the EPA for “making predictions, within its area of special expertise, at the frontiers of science.”
2. Nanosilva’s lower mobility rate (i.e., it is less likely to release silver into the environment):
- The court found the EPA’S reliance on an undisputed textile-leaching study, as well as a contested plastic-leaching study, constituted substantial evidence. Nanosilva’s stability achieved through attachment to a larger particle and diminished release rate relative to silver salts persuaded the court that Nanosilva retained a lower mobility rate.
3. Current users of conventional, silver-containing pesticides would switch to Nanosilva (the substitution assumption), and/or Nanosilva would not be incorporated into new products to the extent that it would increase the amount of silver released (the no-new-product assumption):
- In analyzing the substitution assumption, the court found the EPA’s argument, that market saturation and inelasticity would influence users to substitute conventional silver-containing pesticides with Nanosilva, to be inadequate. The court considered this argument to be a post-hoc rationalization, irrelevant to the silver-containing pesticide market and incapable of supporting the substitution assumption.
- In the absence of factual support, the court concluded that the potential for Nanosilva’s incorporation into new products was inconsistent with the EPA’s no-new-product assumption. Despite prohibitive costs, the potential for incorporation into new products weighed against public interest, given the unsupported substitution assumption.
- Without evidence in the record to support either assumption, the court posited that Nanosilva could elevate the total quantity of silver in the environment. The EPA should have, the court said, used information collected from another silver nanoparticle-containing pesticide, AGS-20, to substantiate the EPA’s assumptions. The court had “to imagine that at least some data about the use of AGS-20 and adoption were ascertainable and would have been useful in evaluating the EPA’s assumptions.”
The void in the EPA’s evidence contravened the language of section 136a(c)(7)(C). The closing of section 136a(c)(7)(C) reads, “that use of the pesticide is in the public interest.” In accordance with the statute, the court interpreted this language to mean that substantial evidence, supporting the public-interest requirement, should have been provided prior to Nanosilva’s conditional registration. Data collected during the conditional registration period cannot fulfill the public-interest requirement.