National Corn Growers Association v. Environmental Protection Agency and Lisa Perez Jackson , Administrator

United States Court of Appeals
FOR THE DISTRICT OF COLUMBIA CIRCUIT
Argued March 22, 2010 Decided July 23, 2010
No. 09-1284
NATIONAL C ORN GROWERS ASSOCIATION , ET AL.,
P ETITIONERS
v.
ENVIRONMENTAL P ROTECTION AGENCY AND LISA P EREZ
J ACKSON , ADMINISTRATOR ,
R ESPONDENTS
On Petition for Review of an Order
of the Environmental Protection Agency
Kenneth W. Weinstein argued the cause for petitioners.
With him on the briefs were Claudia M. O'Brien, Drew C.
Ensign, and Dylan M. Fuge.
Lawrence S. Ebner was on the brief for amicus curiae
CropLife America in support of petitioners.
Alan D. Greenberg, Attorney, United States Department
of Justice, argued the cause for respondent. With him on the
brief was Laurel Celeste, Attorney, U.S. Environmental
Protection Agency.

-- 1 of 15 --

2
Jason C. Rylander was on the brief for amici curiae
American Bird Conservancy, Inc., et al. in support of
respondents.
Before: G INSBURG , TATEL and GRIFFITH, Circuit Judges.
Opinion for the Court filed by Circuit Judge G INSBURG .
G INSBURG , Circuit Judge: The National Corn Growers
Association, the National Sunflower Association, the National
Potato Council, and FMC Corporation petition for review of
the order of the Environmental Protection Agency denying
their objections to the EPA’s Final Regulation revoking all
“tolerances” for the pesticide carbofuran. We grant the
petition for review in part and accordingly vacate the EPA’s
final rule to the extent it revoked import tolerances for
carbofuran. We deny the petition for review in all other
respects.
I. Background
The EPA regulates pesticides pursuant to two federal
statutes: the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA), 7 U.S.C. § 136 et seq., and the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. § 356a. The
FIFRA establishes a registration system under which the EPA
controls the sale, distribution, and use of pesticides. No one
may sell a pesticide unless it has been properly registered with
the EPA, pursuant to the FIFRA, for a particular use, which
requires showing that, so used, the pesticide will not cause
“unreasonable adverse effects on the environment.” 7 U.S.C.
§ 136a(c)(5)(C).
Pursuant to the FFDCA, the EPA determines the
maximum amount of a pesticide residue, which the statute
terms a “tolerance,” that may remain on or in raw and

-- 2 of 15 --

3
processed food. The EPA may establish or leave in effect a
tolerance only if it is “safe,” that is, only if
there is a reasonable certainty that no harm will
result from aggregate exposure to the pesticide
chemical residue, including all anticipated dietary
exposures and all other exposures for which there is
reliable information.
21 U.S.C. § 346a(b)(2)(A). Absent an exemption from the
Administrator of the EPA pursuant to § 346a(c), a provision
not here at issue, any food containing a pesticide residue that
exceeds an established tolerance is deemed “unsafe” and
“adulterated” and may not be moved in interstate commerce.
Id. §§ 331, 342(a)(2)(B).
The agency is required to modify or revoke an existing
tolerance it later determines is not safe, id. § 346a(b)(2)(A)(i),
which it does by way of a multi-step process. First, in what
we refer to as the “comment stage,” it publishes a notice of
the proposed revocation, provides a period for public
comment and, having taken the comments into consideration,
issues a “Final Regulation.” Id. § 346a(e). Second, in what
we refer to as the “objection stage,” any person may file an
“objection” to and request a public evidentiary hearing on the
Final Regulation, after which the EPA issues an order stating
the action taken upon each such objection and request and
“setting forth any revision to the regulation ... the
Administrator has found to be warranted.” Id. § 346a(g)(2).
The FFDCA requires that an objection “specify[] with
particularity the provisions of the regulation ... deemed
objectionable and stat[e] reasonable grounds therefor.” Id. §
346a(g)(2)(A). The Act requires the EPA to hold a hearing
only “if and to the extent the Administrator determines that
such a public hearing is necessary to receive factual evidence

-- 3 of 15 --

4
relevant to material issues of fact raised by the objections.”
Id. § 346a(g)(2)(B). Under the EPA’s implementing
regulations:
A request for an evidentiary hearing will be granted
if the Administrator determines the material
submitted shows the following:
(1) There is a genuine and substantial issue of fact
for resolution at a hearing. An evidentiary hearing
will not be granted on issues of policy or law.
(2) There is a reasonable possibility that available
evidence identified by the requestor would, if
established, resolve one or more of such issues in
favor of the requestor .... An evidentiary hearing
will not be granted ... if the Administrator concludes
that the data and information submitted, even if
accurate, would be insufficient to justify the factual
determination urged.
(3) Resolution of the factual issue(s) in the manner
sought ... would be adequate to justify the action
requested. An evidentiary hearing will not be
granted on factual issues that are not determinative
with respect to the action requested.
40 C.F.R. § 178.32(b).
In 2006 the EPA concluded, in a dietary risk assessment,
that human exposure to carbofuran, a pesticide used to control
insect infestations in a number of crops, is “above the
Agency’s level of concern.”∗
∗ A dietary risk assessment comprises four steps: (1)
identification of the toxicological hazards posed by a pesticide; (2)
The EPA sought to limit

-- 4 of 15 --

5
exposure to carbofuran by revoking all tolerances under the
FFDCA, which action would effectively ban the use of
carbofuran on both domestic and imported food for human
consumption. Referencing its earlier risk assessment, the
EPA stated in the notice of proposed revocation that
aggregate dietary exposure to residues of carbofuran is “not
safe.” Carbofuran; Proposed Tolerance Revocations, 73 Fed.
Reg. 44,864, 44,865/2 (July 31, 2008) [hereinafter Proposed
Revocation]. Specifically, the EPA concluded (1) estimated
exposure from food alone, as well as from food and water,
“significantly exceed[s] EPA’s level of concern for children”;
and (2) estimated exposure for both children and adults who
receive their drinking water from “vulnerable” sources
exceeds the EPA’s level of concern. Id. at 44,865/3.
The petitioners submitted extensive Comments in
response to the proposed revocation. Also during the
comment period, FMC, the only manufacturer of carbofuran
in the United States, voluntarily cancelled its registrations
under the FIFRA for all but six crops and proposed that the
EPA amend the remaining registrations to limit usage in areas
particularly susceptible to drinking water contamination (the
“First FMC Proposal”), which proposal the EPA accepted,
Carbofuran; Product Cancellation Order, 74 Fed. Reg. 11,551
(Mar. 18, 2009).
In May 2009 the EPA issued a Final Regulation revoking
all tolerances for carbofuran. Carbofuran; Final Tolerance
Revocation, 74 Fed. Reg. 23,046 (May 15, 2009). It
concluded that although the First FMC Proposal would reduce
exposure to carbofuran, the aggregate exposure from drinking
determination of the “level of concern” for humans; (3) estimation
of human exposure to the pesticide; and (4) characterization of risk
to humans based upon a comparison between the estimated
exposure and the level of concern.

-- 5 of 15 --

6
water would still exceed the level of concern with respect to
both children and adults. Id. at 23,047/3. FMC then proposed
another amendment to its registration under the FIFRA, which
would further limit carbofuran usage (the “Second FMC
Proposal”), and the petitioners filed Objections and a Hearing
Request. In November 2009 the EPA denied the petitioners’
Objections and Hearing Request. Carbofuran; Order Denying
FMC’s Objections and Requests for Hearing, 74 Fed. Reg.
59,608 (Nov. 18, 2009) [hereinafter Hearing Denial].∗
II. Analysis
The
petitioners seek review of that decision pursuant to 21 U.S.C.
§ 346(h).
The petitioners contend they raised four material issues
of fact with respect to the revocation of domestic tolerances,
each of which merits a hearing: What are the concentrations
of carbofuran in (1) surface water and (2) ground water; (3)
what is the half-life of carbofuran, which is relevant in
determining the extent to which an individual recovers
between exposures; and (4) what is the “safe dose” of
carbofuran, “i.e., the level below which exposures will not
result in adverse effects.” Below we conclude the EPA did
not abuse its discretion by denying the petitioners’ requests
for a hearing on the first two issues, which obviates the need
to address the second two issues, for they are not by
themselves outcome-determinative. The petitioners also
contend that, because the EPA agrees the level of exposure to
carbofuran from imported foods alone is safe, the agency
acted arbitrarily and capriciously by revoking import
tolerances. Before reaching any of these arguments, we
∗ Because the merits of the Second FMC Proposal were to be
evaluated under the FIFRA rather than the FFDCA, the EPA’s
order was “not a determination on [those] proposed registration
amendments.” Hearing Denial, 74 Fed. Reg. at 59,609/2.

-- 6 of 15 --

7
consider the petitioners’ contention that the EPA applied the
wrong standard in determining whether an evidentiary hearing
was warranted.
A. Standard for Holding an Evidentiary Hearing
The parties agree the FFDCA and the EPA’s regulations
establish a “summary-judgment type” standard for
determining whether to hold a hearing: The EPA must hold a
hearing if it determines an objection raises a material issue of
fact. Contrary to the position of the petitioners, however, our
review of the EPA’s exercise of discretion in determining
whether an issue is material differs from our review of a
summary judgment rendered by a district court, which we
review de novo, Venetian Casino Resort, LLC v. EEOC, 530
F.3d 925, 929 (D.C. Cir. 2008).
The proper standard of review here, as we stated in
another case arising under the FFDCA, is “necessarily
deferential.” Cmty. Nutrition Inst. v. Young, 773 F.2d 1356,
1363 (1985).
Mere differences in the weight or credence given to
particular scientific studies, or in the numerical
estimates of the average daily intake of [a
substance], are insufficient. [We] will not substitute
[our] judgment on highly technical and factual
matters for that of the agency charged with the
supervision of the industry.
Id. Rather, our review is “limited to an evaluation of whether
[the agency] has given adequate consideration to all relevant
evidence in the record.” Id. at 1362.

-- 7 of 15 --

8
B. Domestic Tolerances
Having established the standard of review, we turn to the
question whether the issues of fact raised by the petitioners
are material.
1. Concentration of carbofuran in surface water
The petitioners first argue the EPA unrealistically
assumed that in any given watershed the percentage of crops
treated with carbofuran (PCT) is the legal maximum, i.e.,
100%. According to the petitioners, “county-level sales data”
show that in no county where carbofuran has been used is the
actual PCT higher than 4.25, and this fact is confirmed by
data measuring actual carbofuran concentrations in samples of
surface water. Finally, they argue the assumption of 100 PCT
is “wholly untenable” in light of the Second FMC Proposal,
which would purportedly cap the PCT at 2.
The EPA refused to consider any of the documents and
arguments the petitioners submitted during the objection stage
that they could have but did not submit during the comment
stage, holding they were, respectively, untimely and forfeited.
The petitioners argue this ruling was inconsistent with the
FFDCA and the EPA’s own implementing regulations, both
of which provide that objections may be filed after
promulgation of the Final Regulation and do not explicitly
prohibit raising in the objections issues that could have been
but were not raised in the comments. The EPA responds that
its practice of requiring issues to be raised at the first
available opportunity is a reasonable exercise of its broad
discretion to “fashion [its] own rules of procedure” in order to
implement the multi-stage procedures required by the
FFDCA. Vermont Yankee Nuclear Power Corp. v. NRDC,
435 U.S. 519, 534–44 (1978); accord GTE Serv. Corp. v.
FCC, 782 F.2d 263, 274 n.12 (D.C. Cir. 1986). Not only has

-- 8 of 15 --

9
the agency followed this practice in the past, e.g., Mevinphos;
Proposed Amendment and Revocation of Tolerances, 60 Fed.
Reg. 39,302, 39,303 (Aug. 2, 1995) (“EPA believes it is
appropriate to preclude review of objections raising issues not
provided in comments”), but in the Proposed Revocation it
specifically reminded parties interested in the present
proceeding of the practice, 73 Fed. Reg. at 44,865/2 (“EPA
will treat as [forfeited] any issue not originally raised in
comments on this proposal”).
We agree with the EPA. As the agency points out, the
comment period would be redundant and superfluous if the
same concerns could be raised at the objection stage. See
FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120,
133 (2000) (statute must be interpreted as a “coherent
regulatory scheme” with “all parts [fit] into a harmonious
whole”); APWU, AFL-CIO v. Potter, 343 F.3d 619, 626 (2d
Cir. 2003) (statute should be construed “so that effect is given
to all its provisions, so that no part will be inoperative or
superfluous, void or insignificant, and so that one section will
not destroy another”). Nor would a potentially affected party
have an incentive to raise an issue at the comment stage if it
could wait without prejudice to see whether doing so was still
necessary at the objection stage. Cf. Pinos-Gonzalez v.
Mukasey, 519 F.3d 436, 440 (8th Cir. 2008) (approving of the
Board of Immigration Appeals’ rule that an issue not raised at
the initial hearing before an immigration judge is forfeited for
purposes of the administrative appeal). Properly viewed, the
objection stage is an opportunity for internal agency review,
an opportunity for an interested party to challenge — and for
the agency to correct — a matter of fact, law, or policy that
appeared for the first time in the Final Regulation, so-called.
Cf. ASARCO, Inc. v. FERC, 777 F.2d 764, 772 (D.C Cir.
1985) (section 19 of Natural Gas Act, which makes
application for agency rehearing a condition of judicial

-- 9 of 15 --

10
review, “is in part to insure that the [agency] has an
opportunity to deal with any difficulties presented by its
action before the reviewing court intervenes”) (internal
quotation marks deleted). The EPA’s refusal to consider at
the objections stage evidence and arguments that could have
been but were not submitted during the comment period is
also of a piece with the general rule of forfeiture we apply
when reviewing agency decisions, viz., that the court will not
consider an argument the agency was not given a fair
opportunity to consider during the rulemaking. Nuclear
Energy Inst. v. EPA, 373 F.3d 1251, 1290 (D.C. Cir. 2004);
see also Nat’l Lime Ass’n v. EPA, 233 F.3d 625, 640–41
(D.C. Cir. 2000) (agency need not consider information
submitted after the close of the comment period); USAir, Inc.
v. DOT, 969 F.2d 1256, 1260 (D.C. Cir. 1992) (parties “must
not be encouraged to ‘sandbag’ agencies by withholding legal
arguments for tactical reasons until they reach the courts of
appeal”).
The EPA rejected other of the petitioners’ arguments at
the objection stage on the ground they were “recycled” from
the comment stage and had already been addressed when the
agency promulgated the Final Regulation. Hearing Denial, 74
Fed. Reg. at 59,658/1. At that time it had rejected the
petitioners’ arguments concerning the PCT because the
petitioners had failed to submit much of the data and the
methodology they used to arrive at their estimated PCT of
4.25. Final Regulation, 74 Fed. Reg. at 23,065/1. The agency
had also noted in promulgating the Final Regulation that
estimates derived from sales data fail to account for the
possibility that “use patterns of carbofuran could be
concentrated in certain locations, such that a large percentage
of a small watershed is treated.” Id. at 23,066/3. In the order
denying the petitioners’ Objections and Hearing Request, the
EPA concluded that, although “it is unlikely that 100% of the

-- 10 of 15 --

11
crop will be treated ... in most watersheds,” the possibility of
100% treatment, especially in smaller watersheds, meant the
agency was “obligat[ed] to evaluate all legally permitted use
practices ... and [to] ensure that all such use meets the
requisite statutory standards.” Hearing Denial, 74 Fed. Reg.
at 59,658/3.
We agree with the EPA that the petitioners, by simply re-
submitting their Comments, without addressing the responses
the EPA had made to them in the Final Regulation, “failed to
lodge a relevant objection.” Id. at 59,658/1. By statute, an
Objection and Hearing Request must be directed “with
particularity [to] the provisions of the [final rule] deemed
objectionable.” 21 U.S.C. § 346a(g)(2); see also 40 C.F.R. §
178.25(a)(2). In any event, we “will not substitute [our]
judgment on highly technical and factual matters for that of
the agency,” Cmty. Nutrition, 773 F.2d at 1363, and on this
record we cannot say the EPA abused its discretion in
concluding the petitioners failed to present sufficient evidence
to warrant using a PCT lower than 100 when estimating
concentrations of carbofuran in surface water.
Finally, the EPA refused to consider any of the
petitioners’ arguments based upon the Second FMC Proposal.
Hearing Denial, 74 Fed. Reg. at 59,658/2. As mentioned in
the preceding paragraph, an Objection and Hearing Request
must be responsive to the Final Regulation; it must identify
some specific error in the regulation. The Second FMC
Proposal was submitted to the EPA 44 days after publication
of the Final Regulation; Objections that assumed the
amendments had been or would be accepted by the agency
were not responsive to the Final Regulation, and the EPA
properly refused to consider them.

-- 11 of 15 --

12
2. Concentration of carbofuran in groundwater
The second issue of fact the petitioners claim is material
to the Final Regulation concerns the concentration of
carbofuran in groundwater. The petitioners’ challenges to the
EPA’s conclusion that concentrations exceed safe levels turns,
the parties agree, upon a single issue of fact, viz., whether
carbofuran will be applied in areas with soil that is
“vulnerable” to the carbofuran leaching into the groundwater.
In their Comments on the proposed revocation the petitioners
had relied upon a “National Leaching Assessment” they said
was done by a “panel of independent water experts” to
demonstrate the geographic restrictions in the First FMC
Proposal would ensure against carbofuran being used in areas
with vulnerable soils. According to the petitioners, vulnerable
areas include only those with
permeable soils (e.g., areas with soils greater than
90% sand and less than 1% organic matter), acidic
soil and water conditions, and [where] shallow water
tables predominate (e.g., where groundwater is less
than thirty feet).
In the Final Regulation the EPA had noted the petitioners
did not submit the National Leaching Assessment itself and
said they had failed to explain sufficiently the data and
methodologies underlying it. The EPA went on to find the
petitioners’ criteria for vulnerability were underinclusive, and
gave examples of potentially vulnerable areas where
carbofuran could still be used if those criteria were adopted.
Final Regulation, 74 Fed. Reg. at 23,060/1, 23,078–80. Even
taking the First FMC Proposal into account, the EPA had
concluded, concentrations of carbofuran in groundwater
would not be reduced to “acceptable levels.” Id. at 23,080/1.

-- 12 of 15 --

13
In their Objections and Hearing Request the petitioners
restated several arguments they had made in their Comments
and argued the Second FMC Proposal would resolve the
EPA’s remaining doubts about whether carbofuran would be
applied to vulnerable areas. This time they submitted the
National Leaching Study for support, as modified to account
for the Second FMC Proposal.
The EPA denied the Objections and Hearing Request. As
discussed above, it properly refused to consider evidence that
could have been but was not submitted with the petitioners’
Comments, as well as arguments recycled from earlier
Comments and arguments based upon the unapproved Second
FMC Proposal. 74 Fed. Reg. at 59653/1, 59654/3–56/1.
On appeal the petitioners characterize the question
whether their criteria for “vulnerable” areas are
underinclusive as a “dispute between experts,” an accurate but
a fatal description. As we said in Community Nutrition, we
will not overturn an agency’s finding there is no material
issue of fact based upon “[m]ere differences in the weight or
credence given to particular scientific studies.” 773 F.2d at
1363.
* * *
The petitioners have failed to show a hearing was
warranted on either of the first two issues of fact they raised.
Therefore, we need not consider the latter two issues; as the
petitioners acknowledged at oral argument, resolution in their
favor of those two issues alone would not alter the outcome of
the administrative proceeding. See 40 C.F.R. § 178.32(b)(3)
(“An evidentiary hearing will not be granted on factual issues
that are not determinative with respect to the outcome
requested”).

-- 13 of 15 --

14
C. Import Tolerances
The petitioners contend that even if the EPA properly
revoked all domestic tolerances for carbofuran, it acted
arbitrarily and capriciously, in violation of the Administrative
Procedure Act, 5 U.S.C. § 706(2)(A), in revoking the import
tolerances for carbofuran. The EPA acknowledges that
exposure to carbofuran from imported foods alone is safe.
The EPA nonetheless revoked all carbofuran tolerances for
imported foods, contending the petitioners failed to make a
timely request that import tolerances alone be left in effect.
Hearing Denial, 74 Fed. Reg. at 59,675/2.
The agency’s position is untenable, for the petitioners
made such a request on two occasions. First, they included in
their Comments five tables representing increasing tolerances
they were successively asking the EPA to maintain. One
table presented their most modest proposal for retention,
showing exposure estimates for “Import Tolerances ... Only.”
Second, the petitioners expressly stated in a letter to the EPA
that they wanted the agency to retain, at minimum, import
tolerances “separately, by themselves.”∗
∗ The letter was submitted after the close of the comment
period but the EPA did not suggest until oral argument that the
letter was untimely. See BNSF Ry. Co. v. STB, 604 F.3d 602, 611
(D.C. Cir. 2010) (“a forfeiture can be forfeited by failing on appeal
to argue an argument was forfeited”); Ark Las Vegas Rest. Corp. v.
NLRB, 334 F.3d 99, 108 n.4 (D.C. Cir. 2003) (argument raised for
first time at oral argument is forfeited).
The EPA’s
contention the petitioners never asked that import tolerances
alone be maintained seems, from what counsel said at oral
argument, to be premised upon the idea that a party may not
make arguments in the alternative. That is a strange idea,
rejection of which requires no display of learning.

-- 14 of 15 --

15
In sum, the petitioners asked that if all else failed, the
import tolerances for carbofuran should be maintained
because the EPA itself considered them safe. The EPA’s
decision to revoke those tolerances was arbitrary and
capricious.
III. Conclusion
We grant the petition for review in part and vacate the
EPA’s final rule to the extent it revoked the import tolerances
for carbofuran. We deny the petition for review in all other
respects.
So ordered.

-- 15 of 15 --