and Submitted November 17, 2016 San Francisco, California
Petition for Review of an Order of the Environmental
H. Prange (argued), San Francisco, California; Aaron
Colangelo, Washington, D.C.; as and for Petitioner Natural
Resources Defense Council.
A. Kimbrell and Sylvia Wu, Center for Food Safety, San
Francisco, California, for Petitioners Center for Food Safety
and International Center for Technology Assessment.
Chen (argued), Attorney, and John C. Cruden, Assistant
Attorney General, Environmental Defense Section, Environment
& Natural Resources Division, United States Department of
Justice, Washington, D.C.; Amber Aranda, Of Counsel, Office
of General Counsel, United States Environmental Protection
Agency, Washington, D.C.; for Respondent.
Before: Michael J. Melloy, [**] Richard R. Clifton, and Paul J.
Watford, Circuit Judges.
panel vacated the United States Environmental Protection
Agency's ("EPA") conditional registration of
the pesticide NSPW-L30SWS - an antimicrobial materials
preservative that uses nanosilver as its active ingredient -
because the EPA failed to support its requisite finding that
NSPW was in the public interest under 7 U.S.C. §
Federal Insecticide, Fungicide, and Rodenticide Act governs
the sale, use, and distribution of pesticides, and the Act
requires that pesticides generally must be registered with
the EPA before being sold or distributed. The EPA may grant a
temporary, conditional registration if it first determines
that use of a pesticide was in the public interest.
panel held that substantial evidence supported the EPA's
findings that NPSW has lower application and mobility rates
than conventional-silver pesticides.
panel held, however, that substantial evidence did not
support the EPA's finding that use of NPSW was in the
public interest because it had the "potential" to
reduce the amount of silver released into the environment.
The panel held that the EPA's finding was based on two
unsubstantiated assumptions: first, that current users of
conventional-silver pesticides would replace those pesticides
with NSPW; and second, that NSPW would not be incorporated
into new products to the extent that such incorporation would
actually increase the amount of silver released into
the environment. The panel concluded that without evidence in
the record to support the assumptions, it could not find that
the EPA's public-interest finding was supported by
substantial evidence as required by the Act.
MELLOY, Circuit Judge:
Federal Insecticide, Fungicide, and Rodenticide Act
("FIFRA"), 7 U.S.C. §§ 136-136y, governs
the sale, use, and distribution of pesticides. Under FIFRA, a
pesticide generally must be registered with the Environmental
Protection Agency ("EPA") before it is sold or
distributed. Id. § 136a(a). In order to obtain
pesticide registration, an applicant must submit sufficient
data "concerning the product's health, safety, and
environmental effects." Pollinator Stewardship
Council v. EPA, 806 F.3d 520, 523 (9th Cir. 2015). The
registration requirement thus enables the EPA to prohibit
pesticides that will cause "unreasonable adverse effects
on the environment." Id. (quoting 7 U.S.C.
§ 136a(c)(5)). Sometimes, however, the EPA may receive
sufficient data to determine that short-term use of a
pesticide is reasonable, but not enough data regarding its
long-term use. See 7 U.S.C. § 136a(c)(7)(C). If
the EPA lacks this data "because a period reasonably
sufficient for generation of the data has not elapsed since
the [EPA] first imposed the data requirement, " the EPA
may grant a temporary, conditional registration. Id.
But, to issue the conditional registration, the EPA must
first determine "that use of the pesticide is in the
public interest." Id.
case involves the pesticide NSPW-L30SS ("NSPW").
Manufactured by Nanosilva LLC, NSPW is an antimicrobial
materials preservative that uses nanosilver as its active
ingredient. Petitioners-the Natural Resources Defense
Council, the Center for Food Safety, and the International
Center for Technology Assessment-opposed the EPA's
conditional registration of NSPW during public notice and
comment. Petitioners argued the EPA failed to support its
findings that (1) use of NPSW is in the public interest; and
(2) Nanosilva LLC had insufficient time to submit the
required data. The EPA, nonetheless, conditionally registered
NSPW in May 2015. Petitioners filed a timely petition for
review and now renew their arguments before this Court. We
have jurisdiction for direct review of the agency action
pursuant to 7 U.S.C. § 136n(b).
reviewing the conditional registration for substantial
evidence, we conclude the EPA failed to support its finding
that NSPW is in the public interest. We therefore vacate the
registration in whole and need not reach Petitioners'
a materials preservative incorporated into plastic and
textile products. When so incorporated, the EPA explains,
NSPW can help "suppress the growth of bacteria, algae,
fungus, mold[, ] and mildew, which cause odors,
discoloration, stains, and deterioration." NSPW may be used
in products such as trash cans, mops, window blinds,
furniture, baseboards, light switches, plastic decking,
carpet, toilet seats, shower curtains, tubs, cell phones,
computers, plastic components in humidifiers, vacuums, combs,
brushes, electric razors, blow dryers, beds, wall coverings,
wheelchairs, linens, golf bags, exercise equipment, life
preservers, sportswear, nursing uniforms, watch bands,
restaurant uniforms, litter boxes, swimming pool equipment,
ink pens, portable toilets, office supplies, and luggage.
NSPW may not be used, however, in products designed for food
contact, food packaging, or drinking water.
active ingredient in NSPW is nanosilver. Simply put,
nanosilver is a version of "conventional" silver
that is engineered to have a much smaller particle size.
Conventional silver has long been recognized as an
antimicrobial agent and is the active ingredient in a number
of currently registered pesticides used as materials
preservatives. Nanosilver, due to its much smaller particle
size, can have significantly different properties than
conventional silver. These different properties provide new
benefits and opportunities to industry.
with these new benefits come new risks. After companies
seeking to market nanosilver and other nanomaterials began
approaching the EPA for pesticide registration, the EPA
convened a meeting of the FIFRA Scientific Advisory Panel
("the Panel") in November 2009 to discuss potential
hazards. In part, the Panel summarized its meeting as
The Panel was not aware of any information that suggested
that silver ions released from silver nanomaterials would
behave differently than silver ions generated by any other
source. However, the Panel believed that the rate of silver
ion production, as well as the distribution of silver in
[biological] tissue, may differ substantially between silver
nanomaterials and other forms of silver. Nanomaterials can
deliver ions directly to specific tissues, cell membranes or
inside cells. The biological effects of silver nanomaterials
(including temporal pattern for ion delivery), as well as
their environmental fate, can be affected by other materials
present in the preparation (e.g., surfactants).
Nanosilver can also potentially act as a carrier for other
toxic chemicals. These issues led the Panel to suggest that
the hazard profile of silver nanomaterials may differ from
other forms of silver.
Panel thus recommended that the "EPA treat nanosilver
differently from its conventional silver counterpart."
The Panel also "cautioned about extrapolating from one
nanosilver formulation to another when assessing
the Panel convened, the EPA evaluated and conditionally
registered two pesticides containing a form of nanosilver:
AGS-20 and NSPW. Like NSPW, AGS-20 is a nanosilver-based
antimicrobial pesticide used as a materials preservative.
However, unlike NSPW, which is a liquid suspension
incorporated into plastics and textiles, AGS-20 is a powder
which may be used as a surface coating or by incorporation
with textiles only. The nanosilver in AGS-20 also "has
different size range and surface coatings than the nanosilver
in NSPW[ ]." The EPA ...