*1 Harris, open question consti- agreement” at 404 U.S. prosecutions.” sive Rather, they represent tutional law. 183; 56-57, see also Castillo- 92 S.Ct. Dou- misunderstanding of the (“The fundamental Amend Basa, Fifth F.3d at 903 and the Supreme Jeopardy ble Clause Swenson, in v. ment, interpreted Ashe purpose its explain decisions Court already decid of an issue ’relitigation bars operation. evi ed, much additional no matter how intro may government wish dence Conclusion Indeed, in proceeding.”). at a second duce reasons, we foregoing hold For the collateral made clear that . Ashe the Court unreasonably applied the court the state government if applies even estoppel clearly estoppel, estab- rule of collateral evidence the second marshal better can Swenson, upheld v. lished Ashe Ashe, 446, at See time around. U.S. We perjury conviction. there- Wilkinson’s (“Once jury had determined S.Ct. judgment of the district fore affirm the testimony that there was conflicting upon for a granting petition court Wilkinson’s peti- that the a reasonable doubt at least corpus. writ of habeas robbers, the State one of the tioner was or different present the same сould not AFFIRMED. prosecu- in a second evidence
identification robbery Knight hope in the
tion for the jury might find that evi- a different convincing.”).
dence more
estoppel
part
“is a
Collateral
POLLINATOR STEWARDSHIP COUN
Amendment’s guarantee against
Fifth
Honey
CIL;
As
Producers
American
442,
Id. at
90 S.Ct.
jeopardy.”
double
Honey
sociation;
Advi
National
Bee
suspended
guarantee
That
is not
1189.
sory Board;
Beekeeping
American
new
prosecutors uncover
simply because
Smith;
Federation;
R.
Bret
Thomas
showing that defendants who
evidence
Jeffery
Anderson,
Adee;
Peti
L.
S.
taking
after
stand were
acquitted
tioners,
they
they testified that
did
lying when
Permitting
charged offenses.
commit the
PROTEC
U.S. ENVIRONMENTAL
exception.to
protection
a perjury
AGENCY;
Perciasepe,
Bob
TION
a defen
Jeopardy Clause affords
Double
acting
capacity as
his
admin
official
“overriding
con
dant would undermine
USEPA, Respondents,
of the
istrator
Clause,
prevent
is to
of the
which
cern”
vastly superior
government “with
LLC, Respondent-
Agrosciences
resources,”
“wearing] down the de
from
Intervenor.
fendant,
though
'even
innocent he
so that
No. 13-72346.
”
guilty.’ Dowling, 493 U.S.
may be found
(Brennan,
J., dissent
Appeals,
cutions *2 Brimmer, Earthjustice, K.
Janette Se- attle, WA, Gregory (argued), C. Loarie CA, Francisco, Earthjustice, San for Peti- tioners. Dreher, Acting
Robert G. Assistant At- General, torney Environment & Natural Division, L. Resources Christina Richmond (argued), and John Thomas H. Do Envi- Section, ronmental Defense States United Justice, D.C.; Washington, Department of Koch, Counsel, Erin Of Office of General Counsel, United States Environmental D.C., Agency, Washington, Protection Respondents. Landau, Ellis, Kirkland &
Christopher LLP, D.C.; Washington, David B. Wein- Consovoy, berg (argued), William S. Jo- Kakesh, Fansler, Craig seph G. S. LLP, D.C., Rein, Wiley Washington, Respondent-Intervenor. Sylvia
George A. Kimbrell and Shih-Yau Wu, Safety, Food San Francis- Center for co, CA, for Food for Amici Curiae Center Farming Asso- Safety, Organic Northeast Council, ciation Interstate Northeast Or- Association, Massachusetts ganic Farming Inc., Farming Organic Northeast Chapter, Island, Inc., North- of Rhode Association Farming Association of New Organic east Inc., York, Farmers and Organic Maine Association; Defenders Gardeners Earth, Wildlife, Center for Friends Health, Law Conservation Environmental Foundation, Organic and Sustain- Midwest Pesticides, Service, Beyond able Education of North Amer- OPINION Action Network Pesticide Club, ica, Family- National The Sierra Insecticide, Fungicide, The Federal Coalition, Bird Farm and American Con- Act, FIFRA, pro- known as Rodenticide servancy. ap- that lack pesticides hibits the sale of Environ-
proval *3 (“EPA”). Agency Protection mental 136a(a). may deny § The EPA an U.S.C. for when “neces- MARY M. SCHROEDER and Before: sary prevent unreasonable adverse ef- SMITH, Judges RANDY Circuit and N. fects on the environment.” Id. This case KRONSTADT,* Judge. A. District JOHN challenge approval is a to the EPA’s sulfoxaflor, containing which insecticides SCHROEDER; Opinion by Judge highly toxic to initial studies showed by Judge N.R. SMITH. Concurrence polli- bees. Bees essential crops years and in recent important nate AND AMENDED OPINION ORDER dying alarming have rates. Peti- been SCHROEDER, keepers tioners are commercial bee and Judge: Circuit keeping organizations.
ORDER initially proposed to condition- ally register requested sulfoxaflor and ad- Respondents’ petition panel rehear- gaps studies to address in the data ditional ing is GRANTED. regarding pesticide’s effects on bees. Opinion September filed 2015 is later, however, A few months amended as follows: unconditionally registered the insecticides mitigation measures and a with certain opinion page the first replace On lowering of the maximum rate. sentence with: obtaining any It did so without further Insecticide, Fungicide, The Federal studies. Because the EPA’s decision to Act, FIFRA, pro- Rodenticide known unconditionally register sulfoxaflor was lack pesticides hibits the sale of data, based on flawed and limited we con- registration by the Envi- approval and approval clude that the unconditional (“EPA”). Agency ronmental Protection supported by substantial evidence. 136a(a). § 7 U.S.C. registra- vacate the EPA’s We therefore opinion page replace On the first tion of sulfoxaflor and remand. with: Background sentence section prohibits companies selling FIFRA from BACKGROUND any pesticide ap- that the EPA has not prohibits companies selling FIFRA from (cid:127) proved registered. U.S.C. any pesticide ap- that the EPA has not 136a(a). § proved registered. 7 U.S.C. 136a(a). § man- FIFRA uses a “cost-benefit Petitioners’ motion for issuance of analysis date is GRANTED. The mandate shall to ensure there is no unrea- people issue forthwith. sonable risk created for or the envi- * Kronstadt, California, sitting by designation. A. United Honorable John Judge Central District States District for the (B) labeling and other materials re- Washington pesticide.” from ronment comply to be submitted with the quired EPA, 1024, 1032 413 F.3d Coal. Toxics requirement subchapter; of this Cir.2005). (9th allows FIFRA Specifically, (C) perform it will its intended function regis- deny EPA to without unreasonable adverse effects on “unreason- pesticide prevent tration of environment; 136a(a). § effects.” 7 U.S.C. able adverse (D) in accordance with when used effects” is defined adverse “Unreasonable commonly recognized widespread to man or the “any unreasonable risk un- generally it will not cause practices environment, the eco- taking into account envi- reasonable adverse effects on the social, nomic, costs and and environmental ronment. pesticide.” 7 [the] of the use of benefits 136a(c)(5). § 136(bb). 7 U.S.C. U.S.C. *4 three different applied register Dow a pesticide, a new register In order to containing sulfoxaflor as products, each must submit an
manufacturer ingredient. Sulfoxaflor main/active pesti how the describing registration, for targets range a a new insecticide used, the claims made of will be cide receptor It acts on the same insects. bеnefits, description a ingredients, insects as does the class of insecticides re studies done and the of all tests and neonicotinoids, referred to as but its mech- thereof, product’s concerning sults neonicotinoids, anism is distinct from other health, safety, and environmental effects. only member of a currently so it is 136a(c); § Thomas Union Car 7 U.S.C. subclass of neonicotinoids called sulfoxi- Co., 568, 571, 473 U.S. Agr. bide Products mines. insects that are resistant Some (1985). 3325, L.Ed.2d 409 105 S.Ct. other neonicotinoids are not resistant “unconditionally” may either unique because of the mecha- sulfoxaflor 136a(c)(5), § 7 U.S.C. register pesticide, a uses. All neonicotinoids nism sulfoxaflor it, “conditionally” register id. by interfering kill with their central insects 136a(c)(7)(C). conditionally § The tremors, system, causing paraly- nervous pesticide a when there is insuffi- registers Neonicotinoids, sis, including death. insecticides, cient data to evaluate the environmental sulfoxaflor, “systemic” are pesticide, permitting effects of a new onto they sprayed which means reason- chemicals pesticide period to be used “for which then absorb the plants, throughout plant, sub- them ably generation for the and distribute sufficient tissues, pollen, and nectar. Sul- into the requirеd 7 U.S.C. mission of data.” insecticides systemic foxaflor and other 136a(7)(C). registration § Unconditional ways: kill insects in two different therefore necessarily requires sufficient data to eval- they come into contact insects die when uate the environmental risks. they are as when pesticide, with the Dow Respondent-Intervenor In it, they ingest and also when sprayed with applied approval Agrosciences LLC pesticide. absorbed the plant which has 136a(c)(5). under 7 U.S.C. approve the EPA to sulfoxaf- Dow asked FIFRA states that the provision That crops, variety of different lor for use on a register pesti- shall a new administrator cotton, cucurbits, fruiting including citrus* if: cide strawberries, canola, soybeans, vegetables, (A)its wheat, The maximum many as to warrant others. composition is such proposed var- it; rate of proposed claims crop, high- on the with the risk to bees is identified Tier then the depending ied ingre- tiers, being pounds rate of active next Tier 2 and Tier are intended est (“lb a.i./A”) per per application. dient acre to define when and where the risks exist days minimum number of between The magnitude. and their Tiers and 3 “at- ranging by crop, also varied applications tempt to refine characterize risk and/or days. yearly maximum from 5 to the conditions of estimates determine rate of 0.266 and, relevant, risk occurrence ingredient per acre was consistent across identify spatially-and temporally-specific crops. all risks.” part registration application,
As of its regarding Dow made number of claims A. Tier 1 using benefits to sulfoxaflor over other compares At Tier the extent comparable pesticides. These claims and exposed pesti- to which bees would be to a support public for them are not in the cide with the doses at environment public record. record does indicate pesticide Spe- which that is toxic to bees. that a number of commenters to the EPA’s cifically, reviews studies to deter- conditional decision (or mine “acute median lethal dose” regarding made similar claims the need for “LD50”) pesticide, meaning of a the dose at using and benefits of sulfoxaflor. Dow which half of the individual bees tested die. also submitted studies and data about the *5 See 40 C.F.R. EPA 152.3. The looks at species, effects of sulfoxaflor on various the acute median lethal dose for both con- including bees. (i.e., tact sprayed directly doses bees with analyzed the studies submit- chemical) (bees the as well as oral doses using ted a new framework it had consuming pollen nectar or contaminated n recently analyze developed to better the chemical). with the bees, light risks to in of growing concerns on the Based studies Dow submitted as in rapid populations. about the decline part registration application, of its the I. The Pollinator Risk Assessment EPA determined that the acute median
Framework contact lethal dose sulfoxaflor for bees micrograms ingredient was 0.13 of active framework, The new called the Pollina- per bee. The EPA also determined that Framework, tor Risk Assessment was de- the acute median lethal oral dose of sulfox- veloped through consultations between the aflor for micrograms bees was 0.052 EPA, Management Regula- Canada’s Pest ingredient per active bee. These levels of tory Agency, and Department California’s acute median lethal dose mean that sulfox- Regulation. presented Pesticide It was “extremely aflor is classified as toxic” to Advocacy FIFRA in the Scientific Panel honey bees. 2012 in form the оf a document called a Paper.” explains “White The framework EPA The framework then calls for the rely is intended to be iterative and to compare these median lethal doses with multiple lines of evidence to further refine pesticide the concentration of the potential and characterize It risk. there- environment, expected would be fore establishes several tiers of evaluation. pesticide based on characteristics of that “preliminary screening-lev- proposed application The first or rate. as well as tier, identify applied el” Tier is intended to For sulfoxaflor at the maximum potential proposed, expect- whether risks to bees exist. If a rate Dow actually under- suggested oral results concentration environmental ed example, to be some data determined stated the risk. For by bees was consumption ingredient per days pesticide of active several after mierograms was collected concen- expected pro- environmental a rate lower than and at bee. for bees was exposure for contact posed. tration mierograms to bе 0.72
determined per bee.
ingredient Tier 2 B. EPA to divide step is for the The next the risk even with quotients, Because concentrations expected environmental refinement, to exceed the level continued ar- lethal doses to acute median concern, EPA to Tier of proceeded quotient,” it calls the “risk figure at a rive Whereas assessment framework. the risk determined “RQ.” The has or analysis is based framework’s Tier (called for bees over 0.4 quotients risk modeling of bees and statistical on studies “LOC”) trigger or of concern” “level Tier 3 studies laboratory, Tier quotient risk study, as a for further need effects of an are structured evaluate where 10% a scenario represents of 0.4 on bees in the environment. insecticide would be in an of bees environment more analysis focuses on the Tier 1 And whereas killed. of the on individual the effects insecticide exposure to for oral quotient The risk bees, analyses attempt Tier Tier measured at for bees was colony measure the effect on expo- for contact quotient risk while whole. was measured 2.8. to sulfoxaflor sure referred generally Thus, clearly exceeded quotients both studies”; they consist as “semi-field 0.4, expresses at which the the level enclosure placed a tunnel require further enough to concerns serious crops. pesticide-treated forced to feed testing. *6 other, each Because bees interact however, to Tier proceeding Before other, transport and con- feed each analyzed additional studies EPA also differently depending on their sume food residue, or provided regarding had Dow hive, at- role within semi-field that manifests the amount of sulfoxaflor a effect that capture the tempt to better sprayed nectar of pollen in the itself of functioning have pesticide would analysis the risk crops, in order to refine colony. the entire those residue Using exposure. for' oral levels, out differ- separated EPA also nevertheless, a studies, have Semi-field types of different quotients for ent The bees of limitations. number larvae, and different (e.g., adult bees tunnel; thus into by being put stressed worker, such as adult bees castes within tunnels, the bees where in the control even drone, on their dif- queen) depending food, they die pesticide-treated are not fed consumption patterns. ferent in their normal rates than higher at much in the envi- environment. Because quotients different The new risk variety crops, some on a of ronment feed than 0.8 to less types ranged of bees from and some may be treated of which 5.7, to exceed all of which continued not, may over- may tunnel which However, the EPA identified of 0.4. LOC spray- nearby hives effects on state the the residue stud- shortcomings in several addition, the studies crop. In ing one determine ies, that made difficult days seven to ten more than cannot last accurate were the residue results whether the added stress bees incur in the The EPA found that the results from the due to that, may tunnels. This means the studies not at the studies showed rates capture sublethal effects of insecticides (generally 3-67% of the maximum used (i.e., longer to manifest effects that take application proposed), rate the effects on immediately kill bees but ad- short-lived, that do relatively adult bees were last- in versely ability affect their to function ing days or But less. also ways, myriad leading long term de- that, majority concluded because the population). cline application studies used a lower rate than proposed, the one “[t]he direct effect analysis For its Tier Dow submittеd forag- [measures of adult six tunnel semi-field studies. These stud- mortality, flight activity, er bee and be- done at different times over the ies were havioral at the maximum abnormalities] years, widely course of and varied several application presently rate the U.S. is rate, of application terms number of Furthermore, unknown.” due to various tunnels, study replicated, times the limitations in all of the the effect timing pesticide application, dura- sulfoxaflor, applied the maxi- period, tion of observation and the time of rate, mum on both brood devel- year study at which the was conducted. opment long-term colony health was Perhaps significantly, most all but one of “inconclusive.” application the studies used rates substan- tially proposed by below the maximum The EPA’s environmental risk assess- Dow, pounds ingredient per of active ment concluded additional studies acre. The used in rates five of required, including “one or more Tier ranged the six studies from 0.006 to 0.088 2 semi-field tunnel studies conducted ac- pounds ingredient per of active acre. cording guidance.” OECD “OECD” 2012,” study, Organization
The sixth “Ythier had addi- refers to the for Economic Only tional limitations. two of the Development, seven Coordination and an inter- applications organization used the maximum national developed has rate ingredient protocols of 0.134 bee semi-field tests. per acre. The other five In applications regulations, test- the EPA has viewed the ed rates less than the maximum proposed protocols favorably, explaining OECD study they rate. The Ythier develop “can be used to data neces- crop, may sary used cotton as its test which requirements to meet FI- [of 158.70(d)(2). results, have skewed its as cotton is a FRA].” sub- 40 C.F.R. *7 optimal pollen honey source of record suggest does not that those studies and the bees were therefore not able to have ever been conducted.
maintain sufficient pollen during stores of Initial, Proposed II. The Conditional study. Additionally,
the the Ythier 2012 Registration study designed for quantifying the plant’s residue of sulfoxaflor the in nectar data, gaps Because of the in EPA the pollen, studying biological and not for the give approval declined to unconditional to bees; thus, effects of sulfoxaflor on the as proposed sulfoxaflor. It instead to condi- explained, the EPA’s own assessment it tionally register sulfoxaflor while it collect- only biological “limited effects in- part proposed ed additional data. As of its formation.” registration, conditional announced Jan- 2 analysis, uary After its Tier the EPA EPA con- the decided to lower the cluded that additional single application data was needed. maximum rate of sulfox- though the record reveals It did so even ingredi- of active pounds from 0.133 aflor completed requested the Dow never ingre- pounds to 0.09 acre per ent The acknowl- studies. EPA additional proposed EPA also acre. The per dient insufficiency of the data measures, including edged the mitigation other some registration at the maxi- port be- unconditional spraying on restrictions crop-specific gave but sought, mum Dow had guide- rate suggested during bloom and or fore circum- usage under modified approval to best regarding the on some labels lines stances. spray. time justified EPA its new unconditional data, insufficiency of
To address by the addition of registration decision conditional EPA’s lower maxi- mitigation measures: the various and submit to conduct required of 0.09 mum rate tests, “a specifically results of additional acre, longer mini- per ingredient im- active assessing study for Tier 2 sеmi-field between applications, mum strength and intervals colony on pacts spray- restrictions crop-specific certain in accordance brood during bloom. The record ing “an before guidelines” test OECD-established the EPA had ever re- not indicate does study to address additional residue data on the effect of ceived additional any resi- magnitude nature Moreover, the restrictions (e.g., such measures. crop pollinator-attractive dues on apply during bloom canola).” spraying could that these addi- said continuously blooming crops such “any resolve residual tional studies would crops, For cotton citrus. these of sul- the effects uncertainty” regarding language on warning added required foxaflor, it help determine and would label for cu- example, For the label. appli- maximum requested whether Dow’s was man- curbits, and citrus could strawberries pounds per acre cation rate of 0.133 following statement: to contain dated in the future. be used Notify- Advisory Pollinator Statement: about the The EPA was concerned 1 mile of beekeepers within ing known to do time it would during take to bees before area hours treatment Nevertheless, аddressing more studies. them to will product applied allow risk, determined that sulfox- their steps protect take additional while these studies aflor could be used Also, to times limiting bees. because “sulfoxaf- being performed, pollina- and native managed bees when cata- not result applications lor will active, 7 am or e.g., least before tors are time during strophic loss to brood temp- time or pm after 7 local conditional required period F at the site is below 55' erature (emphasis assessed.” performed to be risk to bees. will minimize application, added). it had clas- acknowledged that Registra- The Final III. Unconditional “very highly toxic” sified sulfoxaflor tion exist- acknowledged that the bees. And *8 as to risks inconclusive ing deci- studies announced its Although the EPA colony strength. brood registration of propose conditional sion to of the that all argued EPA Although the re- January pending data, noted, relevant data, than seven less ceipt of additional stud- decided, the six semi-field only two of later, May months at 0.09 ied the effects sulfoxaflor. “unconditionally” register (the ingredient per acre applica- DISCUSSION ultimately tion rate that the EPA uncondi- FIFRA, reviewing Under а court tionally approved). The EPA nevertheless register EPA’s decision to a new insecti- “potential concluded that while there exists cide shall uphold the EPA’s “if decision exposure hazard to from to sulfoxaf- supported by is substantial evidence when lor,” appropriately that hazard will be miti- considered on the record as a whole.” 7 rates, gated by “reduced in- 136n(b). § U.S.C. application intervals, creased minimum pollinator-related labeling' mitiga- and the jurisdiction We have under 7 tion.” 136n(b). § U.S.C. All parties agree give could unconditional that the studies underlying the EPA’s Tier registration if usage would result unrea- analyses had serious limitations. No sonable adverse environmental effects. additional studies were submitted to evalu applying concluded that sulfoxaf- ate mitigation measures the EPA add lor according to the label would not cause ed in its unconditional registration. We bees, “unreasonable adverse effects”' on cannot conclude that the reg unconditional and that “the benefits com- [sulfoxaflor] istration supported by the record as a pared registered alternatives, to the as whole. ability well as pro- [sulfoxaflor’s] to control respеct With to remedy, we conclude we target pests” blematic outweighed the must vacate the registration and remand justified costs and therefore registration. agency. to the Overall, despite its earlier grant refusal to registration unconditional pending addi- I. Limitations in Tier 2 Studies tional and despite the lack of any meaningful study of the effects of the miti- regulations The EPA’s require the EPA measures, gation the EPA concluded that all “Review[ relevant data pos- ] in [its] ” no additional data on sulfoxaflor was re- session and to “determine[ ] no ad- quired. ” ditional data are necessary to make de-
After the EPA announced its final deci- terminations of no unreasonable adverse sion to unconditionally register sulfoxaflor, 152.112(b)-(c). § effects. 40 C.F.R. petitioners a petition filed for regulations review with require also testing “field for court, this claiming that the EPA’s pollinators” deci- to be submitted as part of an supported by sion was not substantial evi- registration if data from dence in the record as a whole. Dow and other sources honey indicates a risk the EPA registration 158.630(d) (e) defend the § decision bees. 40 C.F.R. n.25. that, by arguing while the parties that, studies submit- All agree because some data limitations, ted Dow had the EPA potential indicated a risk of adverse effects glean nonetheless able to colonies, sufficient useful required Dow was data from the studies support regis- pollinator to submit testing. field In the decision, tration Paper retains White addressing the new tiered flexibility type to determine the data assessment framework for pollinators, needed to support registration in each the framework drafters noted that while case. The EPA thus requirement maintains testing of “field polli- record contains sufficient evidence to nators” in 40 general, C.F.R. 158.630 is port its unconditional at the semi-field studies satisfy would that re- lower maximum rate. quirement. *9 the effects of about slightly more data not did submitted data
What only of two different Portions application. at either approval port regarding the effects provided data of pounds 0.133 rate of maximum proposed application the maximum sulfoxaflor at of the reduced acre or per ingredient active acre: Ythier 2012 per pounds rate of 0.09 pounds 0.09 of maximum rate rate at or above 0.089 application used an reg- original conditional In its ingredient. appli- for four of its per acre sеven pounds decision, required EPA had istration applica- an 2009 used cations. Hecht-Rost guidance.” “OECD testing per additional of acre as one pounds per of tion rate 0.088 deficien- a of number The record reveals applications. five studies, submitted semi-field cies Dow’s to OECD not conform of did most which it was study, because 'The Ythier regula- Although the EPA’s guidelines. residues, not plant quantify designed per- be that studies not mandate tions do effects, had other limitations. biological guide- with OECD in accordance flight formed forager mortality, It not did assess that studies lines, state regulations behavior, reference intensity, forager protocol with OECD (meaning done accordance of sul- the effect toxicant effects requirements meet the data toxic will suffice to known compared foxaflor 158.70(d)(2). tunnels), C.F.R. and it did ofFIFRA. 40 chemicals on control for in- controls any include concurrent not Dow’s sub- the deficiencies Some de- effects or brood biological terpreting the fact unrelated were mitted studies in the were noted velopment. These comply with did not that these studies assessment. EPA’s environmental in- Such deficiencies guidelines. OECD a number of in the tunnel also had inhеrent Hecht-Rost 2009 limitations cluded of a bees was an infestation that limitations: there fact study design, such mite, honey bee in a can kill placed which pest, stress when Varroa undergo significant colonies; long pre-exposure to the related there was tunnel, limitations and some which, days, of 11 used were in the period rates tunnels application fact that the being in stressed the maximum that given than lower generally much data; the colo- tunnels, compromises rate. Some application proposed ameliorated, different widely between the varied limitations have been nies would tunnels; a short observation with there was however, studies conformed had n were few days; and there example, proper only period For guidance. OECD Furthermore, used, tunnels. the studies in the been larvae have controls could times, included no observation more replicated Hecht-Rost 2009 been could have from the removed have been observed after the hives could and the bees applica- of the five being only re- And one time after tunnels. longer period an data about provided tions the tunnels. moved from per acre. pounds аround rate 0.09 originally problems One of the Moreover, regardless of the all was the Tier .2 studies identified addi- rate, an suffered from studies used one of only in- provided they flaw: significant rate, tional pounds 0.133 maximum the ef- data on or insufficient conclusive' study, acre, Ythier per on brood residue, fects of sulfoxaflor quantifying designed for Because colony health. Yet, long-term effects. studying biological “su- interdependent colony is honey bee approved, rate lower an insecticide effect of only perorganism,” the acre, per *10 type ripple through on one of bee can appear ative effects could on the hive-level hive. The two studies that a longer period: over time for example, best the death evaluating foraging data for the effects on bees that occurs immediately development, sprayed brood Schmitzer 2011a and after sulfoxaflor is 2011b, might premature lead to application used rates less than half recruitment of hive bees into forager of the EPA’s new maximum work force. rate of 0.09 studies, pounds per acre. In these two It the basis of all of these defi- measurements brood termination rate noted, ciencies and others it that the EPA (the number of brood that fail to develop January in 2013 concluded that it needed in through emergence) the control tun- additional regarding studies the effect on quite high, nels was with 56% and 65% of development brood long-term colony failing By compari- the brood to survive. strength. That was EPA when the decid- son, other studies according done grant ed to only conditional reported OECD Guideline 75 brood termi- registration. nation control in rates 8^13% five con- Though the EPA specified January studies, trol with three of the five controls that the additional necessary studies were
reporting high brood termination rates to evaluate whether sulfoxaflor could ever only poor because of weather. be used at proposed the maximum applica-
Because the
emerge
brood failed to
tion rate of
pounds
ingredi-
active
high rates even in the control tunnels in
acre,
per
ent
approval
unconditional
the Schmitzer
the controls were May
rate,
2013 was for a
application
lower
comparison
suitable
with the brood the limitations of the data regarding brood
termination rates of the tunnels treated
devеlopment
long-term
colony
sulfoxaflor; thus,
there was inconclu-
strength exist even with the lowered appli-
sive data
toas
the effect of sulfoxaflor on
pounds
cation rate of 0.09
per
By
acre.
brood
Accordingly,
termination rate.
even the EPA’s own reckoning, the data was
these two studies reveal little about the
insufficient to evaluate the effect of sulfox-
effect of sulfoxaflor on brood development,
aflor on brood development and long-term
both due to the low
rates used
colony strength. The decisions are not
problems
and due to
with the control tun-
later,
consistent. The
ap-
unconditional
high
nels that caused
brood losses.
proval
support.
lacks
addition,
In
all of the semi-field
In
studies
addition to needing studies on brood
provided limited
longer
about
long-term
information
colony
colony
term effects on
strength.
strength,
it is clear that
the EPA was
three studies with valid controls that stud-
lacking sufficient data
impact
on the
colony
ied
strength all used application sulfoxaflor generally even at the reduced
rates of
half
about
the new maximum ap-
rate of 0.09
plication rate. The studies that
ingredient per
did not
acre. The EPA
only
had
have valid controls measured
colony portions of two studies evaluating the ef-
strength before
and after
and fects of sulfoxaflor at that rate. And the
did not discern a measurable decline in
recognized
EPA also
condi-
however,
colony strength;
these
tional
it needed more
colony
measured
health
relatively
over a
regarding
the residue of sulfoxaflor
period,
short time
days
between 7 and 17
that appears in nectar
pollen
crop
ain.
after sulfoxaflor treatment.
pollinator-attractive,
as-
that is
such as canola.
sessment acknowledged that different neg-
submitted,
On the basis of the studies
of concern”
of the “level
its definition
evidence
substantial
lacked
*11
But at least
inherently conservative.
sul-
is
of
that
its conclusions
port
the
do exceed
acre
of the measurements
per
some
pounds
of 0.09
a rate
at
foxaflor
concern,
indicates
and where data
of
adverse
level
unreasonable
not have an
would
the EPA’s
pollinators,
risk to
potential
the environment.
effect on
field
pollinator
test-
mandate
regulations
since the
that
argue
EPA and Dow
The
(e)
158.630(d) and
n.25
40
ing.
C.F.R.
risks
as to the
inconclusive
arе
studies
non-
(table
requirements for
showing data
bees,
affirma
the studies
organisms,
aquatic
target
terrestrial
not cause
does
that sulfoxaflor
tively prove
bees). Moreover,
the
including
on bees.
effects
adverse
unreasonable
significant
noted
short-
assessment
EPA’s
can sustain
precedent
nor
logic
Neither
which creat-
in the
studies
comings
residue
held
previously
have
position. We
this
the
extrapolation of
uncertainty in the
ed
ambiguous
rely on
agency cannot
that an
may
understated
which
have
results
that the
of a conclusion
evidence
studies
in accordance
EPA acted
risk.
The
Her
Tucson
support. See
do not
studies
and common sense
regulations
its
Salazar,
F.3d
566
v.
Soc.
petological
Tier 2.
proceeding
(9th Cir.2009)
the Secre
(finding that
affirma
he
erred when
the Interior
tary of
that we cannot
held
previously
haveWe
and inconclusive
ambiguous
tively relied
regulations
avoid its
the EPA to
own
allow
conclusion).
limi
The
support
studies
risk
trigger
measurements
when actual
case
in this
underlying data
tations
concerns,
the measurements
even where
be
can
conclusion
no
that
such
mean
of measure-
neighborhood”
“in the
were
reached.
trigger such concern.
not
ments that would
be
may
an argument
such
said
We have
2Tier
argues that
EPA also
is
matter” but
practical
taken as a
“well
analysis at
only required
are
See Natu-
legal
as a
matter.”
“irrelevant
above
measurements
phase
shows
EPA,
F.3d
Council
ral Res.
and,
at
lower
concern
level of
Def.
Cir.2013)
that,
(9th
(holding
873, 883-84
pounds
rate of
by a
triggered
was
risk concern
where
acre,
the residue
few of
per
ingredient
1,000,
equal
than
less
measurement
trig-
enough to
high
measurements were
ex-
measured
four treatments
one
Thus, the
of concern.
acute level
ger the
that
argue
1,000,
EPA could not
actly
showing was
us to conclude
EPA asks
triggered).
concern
the risk
trigger
as not to
enough”
“close
so
that
that case
similarly argued in
had
2 studies.
for Tier
requirement
very
conser-
based
its
were
calculations
that
that
is irrelevant
contends
therefore
estimate
so a
assumptions,
vative
severely flawed.
2 studies
the Tier
was close
threshold
to the
was “close”
is
fly.
It
just does not
argument
This
argument,
rejected
Id. We
enough.
pounds
that,
rate of 0.09
lower
trae
as-
EPA’s
cannot “revise
holding that we
measure-
acre,
nectar
only of
per
decision, or
rule of
its
alter
sumptions,
mеasure-
pollen
the 66
and 1 of
ments
Id.
risk assessment.”
our own
perform
study
above
in the Ythier
ments
EPA chose
here. The
is
The same
true
1 of the
only
And
of concern.
the level
at a measure-
concern
level of
set
other residue
measurements
nectar
conservative,
overly
it now feels
(MRIDs
ment
own
agency’s
alter the
court cannot
but a
48755601)
of concern.
the level
was above
set its level
And because
rule.
argues,
true,
be
It
well
may
concern
accordingly,
because at least weigh the seriousness of
agency’s
er
some of the residue measurements with
against
rors
“the disruptive consequences
the lower
rate of 0.09
of an interim change
may
itself be
per acre still triggered the acute level of
changed.”
Toxics,
Cal.
Against
Cmties.
concern, pollinator
testing-
field
was re-
“It is
See,
well-established that
agen
an
risk such harm.
e.g., Idaho Farm
cy’s
all,
action must
upheld,
Fed’n,
be
if at
(choos-
on the Bureau
58
F.3d
1405-06
by
agency
basis articulated
ing
itself.”
not to vacate
setting
because
aside
U.S.,
Motor Vehicle
Ass’n
listing
Inc.
of snail species
endangered
as
Mfrs.
Co.,
State Farm
Mut. Auto. Ins.
would
potential
risk
extinction of that spe-
463.
29, 50,
2856,
U.S.
103
cies);
S.Ct.
FIFRA
(1989);
& Elec.
Balt. Gas
Co.
377
must L.Ed.2d
court
FIFRA,
reviewing
a
Under
87,
Inc.,
Council,
462 U.S.
Nat. Res.
regis-
v.
if the
pesticide
a
sustain
Def.
(1983);
2246, L.Ed.2d 437
76
103, 103 S.Ct.
evi-
by substantial
supported
“is
tration
Club, 427 U.S.
v. Sierra
Kleppe
see also
as a
the record
considered
dence
2718,
576
49 L.Ed.2d
412,
390,
96 S.Ct.
136n(b).
“Substantial
7 U.S.C.
whole.”
a
requires
(1976) (“Resolving
issues
these
a mere scintilla
more than
means
evidence
and is
expertise
technical
level of
high
it is such
preponderance;
than a
but less
discretion
informed
left
properly
mind
a reasonable
evidence
relevant
agencies.”). We
federal
responsible
a
adequate
support
accept
might
length
our
this deference
v. discussed
Council
Res.
Nat.
conclusion.”
Def.
v.
Council
Lands
Cir.2013)
decision
(9th
banc
en
873,
EPA,
877
F.3d
735
Cir.2008) (en
(9th
McNair,
981
F.3d
586,
537
Astrue,
F.3d
572
v.
Vasquez
(quoting
by Winter
grounds
banc),
on other
rev’d
Cir.2009)).
is “rela-
(9th
The standard
591
7,
Inc.,
Council,
555 U.S.
Res.
factfinder,” Nat.
agency
to the
tively deferential
Def.
(2008). In
249
365, 172 L.Ed.2d
careful,
129 S.Ct.
“searching and
be
still
but must
it “is not
Council,
explained
we
close Lands
decision to
agency’s
subjecting
court”
appellate
a federal
proper
a
role
Corp.
Containerfreight
scrutiny.”
judicial
in-
scientists
panel of
(9th
as a
to “act
419,
States,
F.2d
v. United
its
to validate
how
agency]
[an
structs
omit-
Cir.1985) (internal
marks
quotation
among scientific
..., chooses
hypotheses
ted).
...,
and orders the agency to ex-
rationally connected to the data. The
plain every possible scientific uncertainty.” EPA has not
a satisfactory
“articulate[d]
Rather,
Id. at 988.
agency
“must have
explanation for its
action” or
rely
discretion to
on the
opin-
reasonable
adequate basis for us to reasonably discern
ions of
qualified
its own
experts even if ...
path.
43,
the EPA’s
Id. at
Pursuant
assessing im-
study for
Tier 2 semi-field
mitiga-
identify and evaluate
colony strength
assessment,
pacts
a Tier
conduct
options,
tion
with
accordance
2 brood
a Tier
conducted
or do both.
guidеlines.”
test
OECD-established
are used
2Tier
assessments
assessment.
only-
that Dow’s studies
EPA also noted
empirically-
specific,
pesticide
“obtain
cotton, so “addition-
tested sulfoxaflor
repre-
potentially
data
exposure
based
magnitude
the nature
al data on
by bees.” Unlike
received
sent doses
pollina-
more
in one or
residues
risks identified
Tier 1
quantitative
be needed.”
crops would
tor-attractive
quali-
are described
2 assessments
in Tier
still
2 assessments
EPA’s Tier
tatively.
com-
assessments
After the
rates of
study application
purported
conditionally reg-
the EPA
plete,
However,
of the
only one
lbs
0.133
a.i./A.
rate of
at a reduced
istering sulfoxaflor
submitted
semi-field
tunnel
six
proposed conditional
In its
lbs
a.i./A.
appli-
used
assessment
for Tier
about
nothing
said
registration,
*15
tested
remaining studies
cation rate.
unconditional-
sulfoxaflor
registering
later
or less.
lbs
of 0.089
rates
application
a.i./A
Rather,
stat-
the EPA
ly at 0.09 lbs a.i./A.
condition-
registering sulfoxaflor
2 ed it was
Tier
from the
conclusions
The EPA’s
obtain
time
the EPA
to
ally .only provide
to
corre-
The results
tepid.
studies were
uncertainty
any residual
“resolvfing]
data
de-
categories: brood
three
sponded with
appli-
sulfoxаflor
of
effects
potential
effect,
colony on
and
direct
velopment,
long-
brood
EPA cations
development,
Of brood
strength.
appli-
maximum
colony health at the
term
consider-
and in
as a whole
stated: “Taken
(0.133
...
initially proposed
limitations,
rate
cation
respective
of their
ation
[a.i/A]).”
determined
The EPA
lbs
tunnel
2]
the six
from
[Tier
results
“necessary,” be-
data was
additional
this
conclusively demonstrate
to
are unable
evidence
“no conclusive
was
cause there
adversely
applications
whether sulfoxaflor
brood
more subtle
long-term
rule out
at
development, even
impact brood
Regard-
by sulfoxaflor.
caused
impacts”
Regarding
used.”
rates
application
lower
lbs
rate of 0.09
ing the lower
not
did
effects,
EPA stated it
direct
data
only that
a.i./A,
EPA said
had
sulfoxaflor
direct effect
know what
applications [would]
indicated “sulfoxaflor
the maximum
at
applied
brood
loss to
catastrophic
Instead,
result in
not
lbs
of
rate
a.i./A.
during
period
the time
required
the Specifically, I
return
only
EPA’s
for
conditional studies
be performed
clear statement explaining how it arrived
assessed.” The EPA
public
received
com- at its finаl decision: “After
review the
ment concerning the proposed
public
conditional
comments and further consideration
registration. The EPA did not
database,
conduct of the
EPA has concluded that
any additional studies.
registration
unconditional
sulfoxaflor,
with lowered application rates and other
Ultimately, the
granted
EPA neither
mitigation is supported by available data
conditional registration,
for which it had
and therefore the appropriate regulatory
public comment,
received
nor the uncondi-
decision.” The
questions
obvious
in read-
tional registration
a.i./A,
at 0.133 lbs
ing
(1)
explanation
this
are: What “data-
which it
requested
had
more data.
In-
(2)
base”? and What “available data”? As
stead, the EPA granted
reg-
unconditional
court,
the reviewing
we must know the
istration of
at
0.09 lbs a.i./A
questions. Yet,
answers
these
the EPA
with numerous mitigation measures
explains
never
which data it
included
place.
no opportunity
analysis.
public
comment on this unconditional
registration. However, the EPA
argue
did
record,
From the
it seems certain that
in favor
unconditional registration in the EPA relied on two sets of studies in
its responses to comments
made
the. making its final decision: the
Tier
publiс regarding
conditional
Tier
which were conducted to
registration. The EPA’s
regis-
decision to
determine whether sulfoxaflor posed a risk
ter sulfoxaflor unconditionally at 0.09 lbs
to pollinators when applied at the maxi-
based on new
a.i./A
evidence.
mum
rate of 0.133 lbs
In
a.i./A.
Rather it was based
aon
“review of the
words,
other
to unconditionally register
public comments [on the conditional regis-
sulfoxaflor at
the maximum application
tration] and further consideration of the
rate of 0.09
a.i./A,
lbs
the EPA relied on:
database.”
(1) the same
Tier
studies that found
Based on
action,
this
course
I have to
sulfoxaflor’s risk
effects on
all life stages
wonder whether
the EPA actually ob-
and castes of bees exceeded the level of
tained substantial evidence to support the
concern;
(2)
the same
registration,
unconditional
shortly after it
that the EPA called unreliable in the exec-
proposed the
conditional
summary
utive
of its Environmental Fate
rate.
I
same
am inclined to believe
and Ecological Risk Assessment for Sul-
the EPA instead
register
decided
sul-
Registration.
foxaflor
fair,
To be
foxaflor unconditionally in response to only found the
2Tier
studies unreliable as
*16
public pressure for
product
the
and at-
to
on
data
colony strength
brood
and
de-
tempted
support
to
its decision retroactive-
velopment,
effects,
not direct
but this does
ly with studies it had previously found not lessen the import of that critique. Nor
inadequate. Such
capricious.
action seems
did the EPA’s concerns disappear after
further review of the data.
In its Decision
Explanation
II.
and Connection with Document, the EPA wrote: “The effect of
Data
sulfoxaflor on
brood
is con-
Setting aside the EPA’s procedure, I
sidered inconclusive due to the limitations
”
still do not find that
EPA supported
the
its
associated with the available studies....
decision with a satisfactory explanation
It continued:
design
“[T]he
the Tier 2
that was rationally connected to the facts.
studies does not
potential
enable the
for
con-
evaluations
coloniesjto
primary
the
dis-
reviewed
be
[on
effects
long-term
colleagues,
their international
by
ducted
completely.”
counted
extensively
specif-
on
and communicated
no
us with
also
has
EPA
The
issues. Additional
disciplines
ic
and
original
the
whether
to
basis
determine
the
further reviewed
committees
EPA
2Tier
the six
or
1Tier
studies
refined
pro-
review
joint
the
under
work done
stan-
procedural
with
conformed
studies
ject.
a poor
done
EPA
only has the
Not
dards.
run
tests were
many
the
explained
how
explaining
However,
EPA never
job
followed,
has
conducted,
the EPA
results
they
what
were
how
type of
for
comparison
any
provide
to
Nor did
also failed
obtained.
or
results
what
of tests
determine what number
us to
of its “exten-
the outcome
explain
the EPA
The
acceptable.
are
of results
range
con-
analysis
what
this
analysis,” whether
sive
compare with
we have
only guidelines
pes-
for other
analyses
with similar
formed
Eco-
for
Organization
are the
the studies
relied on
ticides,
how the EPA
or even
Development
Cooperation and
nomic
The
making its final decision.
analysis in
Office of
(OECD)
guidelines
any conclu-
explain
not
certainly
EPA
did
Prevention
Pollution
Safety and
Chemical
the rea-
studies or
from those
sions drawn
not
EPA
(OCSPP)
does
The
guidelines.
reli-
to be
the studies
sons
considered
it
in describing
guideline
to either
refer
Council,
at 994.
537 F.3d
Lands
able. See
In-
sulfoxaflor.
for
conducted
tests Dow
reliance
the EPA’s
concern is
equal
Of
acknowledges that
stead,
EPA
its re-
In
in the database.
on
not
data
2Tier
did
for
submitted
semi-field
comments,
fre-
the EPA
public
sponses
guidelines.
with OECD
comport
not
of information
cites lack
quently
compen-
argues
EPA
that
instance,
For
final
port
its
decision.
Tier 1
in the
any uncertainties
sated
cause
will not
that sulfoxaflor
as evidence
mitigation
adopting
2 studies
and Tier
losses,
EPA states
honey bee
However,
EPA has
measures.
any sulfoxaf-
[of]
no reports
“has received
the record show-
studies in
any
pointed to
use
the 2012
from
incidents
lor-related
data
these
EPA obtained
ing that the
exemption]
[emergency
section
under
does
measures. Nor
mitigation
agencies
lead
state
authorizations.-
testimony
or
any
scientific
point
asked
were not
they
informed
its conclusions
support
in the record
they re-
investigations
any
to conduct
See
measures:
mitigation
regarding
adverse incidents.”
reports
no
ceived
Council,
at 994.
537 F.3d
Lands
that sulfoxaflor'
its
bolster
claims
And to
pesticides
to other
refers
than
periodically
is better
The EPA
“not
isit
re-
the EPA states
throughout
replace,
will
in the “database”
data
indi-
that would
pro-
information
any
comments
aware
public
sponses to
aas
result
losses
'honey
but none
registration,
cate that
conditional
posed
exceed
would
in detail in
to sulfoxaflor
exposure
explained
these data
currently ex-
those
instance,
the EPA refers
different than
any
be
record. For
insec-
registered
currently
studies:
analysis”
perienced
of outside
an “extensive
It is
cites no studies.
The EPA
analy-
ticides.”
an extensive
conducted
*17
evi-
record contains
that the
noting
worth
in collaboration
sis
would
sulfoxaflor
pesticides
dence that
in Canada
agencies
counterpart
honey bees
more harmful
replace
au-
all
from three
Australia. Scientists
has
However, the EPA
than sulfoxaflor.
peer
400
reviewed over
thorities
pointed
to this evidence or
376,
demon- U.S. at
However,
S.Ct. 1851.
strated that
it deems those studies reli-
there
a great
difference between order-
Council, Inc.,
able. See N. Plains Res.
ing
agency
an
“explain every
possible
F.3d at
1075. Nor has
pro-
uncertainty,”
Council,
scientific
Lands
vided
connection between the evidence
988,
F.3d
and requiring it to “articulate
in the record and the EPA’s decision.
satisfactory
explanation for its action”
Farm,
43,
State
Rather than citing to definitive informa- not meet thе substantial evidence standard tion, the EPA repeatedly dismisses data independent of data Otherwise, and facts. gaps and inconclusive evidence with the always standard could be met with the explanation “believed,” that the EPA “had sworn declaration expert stating knowledge,” or profes- “relied on its best expert’s experience alone made opinion his sional judgement.” instance, For trustworthy. me, For unless I am provid- states: “Although statistical weaknesses ed with evidence of the EPA’s basis for its studies], documented for [the Tier judgment and knowledge, I can only as- Agency rely did not exclusively on sume it acted with none. interpretation statistical of results in its Rather, findings. risk it relied on its best
professional judgment in evaluating the
magnitude and duration of effects from
these studies.” also said:
Although longer-term results from tun-
nel studies conducted at the current single
maximum application rate of 0.086 lb are desirable for confirming a.i./A DeWayne JONES, Ernest results of the assessment, Petitioner-Appellee, Agency believes that when results of Tier 1 and mitigation considered, measures are the existing DAVIS, Ron Warden, Respondent- limitations in the Tier 2 studies do not Appellant.
preclude registration of given (such mitigation measures as re- No. 14-56373. duced rates and increased United States of Appeals, Court intervals) spray minimum that are in- Ninth Circuit. cluded on the label and the benefits provided by sulfoxaflor. Argued Aug. Submitted 2015. Although the EPA certainly authority has Filed Nov. 2015. rely beliefs, its well-founded scienti- fically-derived knowledge, and experience-
driven professional judgment, it must beliefs,
port the knowledge, and judgment
with evidence. We will grant continue to
agencies great deference, particularly in
cases, one, such as this which involve “sub-
stantial agency Marsh, expertise.”