United States Court of Appeals

FOR THE DISTRICT OF COLUMBIA CIRCUIT

Argued March 22, 2010 Decided July 23, 2010

No. 09-1284

NATIONAL CORN GROWERS ASSOCIATION, ET AL.,

PETITIONERS

v.

ENVIRONMENTAL PROTECTION AGENCY AND LISA PEREZ 

JACKSON, ADMINISTRATOR,

RESPONDENTS

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.
2

Jason C. Rylander was on the brief for amici curiae

American Bird Conservancy, Inc., et al. in support of 

respondents.

Before: GINSBURG, TATEL and GRIFFITH, Circuit Judges.

Opinion for the Court filed by Circuit Judge GINSBURG.

GINSBURG, 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 
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 
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 
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. 
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. 
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. 
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
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 
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 
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 resubmitting 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.
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. 
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”).
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.
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.