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In the U.S. Court of Appeals for the Second Circuit

__________________ Natural Resources Defense Council, Inc., Petitioner,

v. United States Environmental Protection Agency, Respondent.

__________________ On Petition for Review of an Or der of the United States Environmental Protection Agency

__________________ PETITIONER’S REPLY BRIEF

Aaron Colangelo Natural Resources Defense Council 1200 New York Ave., NW, Suite 400 Washington, DC 20005 202

- 289

- 2376 Counsel for Petitioner NRDC
De cember 2, 2010i TABLE OF CONTENTS TABLE OF CONTENTS

................................ ................................ ........................... i TABLE OF AUTHORITIES

................................ ................................ ................... iii INTRODUCTION

................................ ................................ ................................ ..... 1 ARGUMENT

................................ ................................ ................................ ............. 2 I. NRDC Is Entitled to an Evidentiary Hearing to Resolve Disputed Material Facts.

................................ ................................ ................................ 2 A. NRDC Identified a Material Issue of Fact Regarding the Statistical Power of the Dichlorvos Human Study.

................................ ..................... 5 1. EPA improperly refused to hold a hearing because it disagrees about the facts in dispute.

................................ ................................ ....... 6 2. NRDC submitted specific evidence challenging the statistical deficiencies in the dichlorvos human study.

................................ .......... 7 3. NRDC identified a material dispute of fact about the statistical validity of the dichlorvos study.

................................ ............................. 8 B. NRDC Identified a Material Issue of Fact Regarding Whether the Dichlorvos Human Study Established Informed Consent.

...................... 11 1. In order to justify a hearing, NRDC need only establish a disputed factual issue, not conclusively resolve the dispute.

.............................. 11 2. EPA improperly d enied NRDC’s hearing request by claiming that there was no factual dispute to be resolved.

................................ ......... 14 3. EPA set the bar too high to demo nstrate a disputed issue of fact regarding informed consent.

................................ ................................ . 16 II. EPA Unlawfully Waived the Children’s Safety Factor Required by Law.

................................ ................................ ................................ .............. 17 A. The Food Act Prohibits EPA from Waiving the Children’s S afety Factor in the Absence of Required Data.

................................ ................. 18 B. EPA Failed to Provide a Reasoned Basis for its Safety Factor Decision.

................................ ................................ ................................ ... 22ii C. NRDC Did Not Waive this Challenge to EPA’s Unlawful Safety Factor Decision.

................................ ................................ ........................ 23 CONCLUSION

................................ ................................ ................................ ........ 26 CERTIFICATE OF COMPLIANCE

................................ ................................ ....... 28 PROOF OF SERVICE

................................ ................................ ............................. 29iii TABLE OF AUTHORITIES Cases Am erican Cyanamid Co. v. Food & Drug Admin ., 606 F.2d 1307 (D.C. Cir. 1979)

................................ ................................ .................... 3, 4, 13, 17 Anderson v. Liberty Lobby, Inc. , 477 U.S. 242 (1986)

................................ ............ 14 Bastek v. Fed. Crop Ins. Corp. , 145 F.3d 90 (2d Cir. 1998)

................................ ... 26 Chambers v. TRM Copy Ctrs. Corp ., 43 F.3d 29 (2d Ci r. 1994)

............................ 15 Citizens for Jazz on WRVR, Inc. v. FCC , 775 F.2d 392 (D.C. Cir. 1985)

.... 4, 12, 13 Dolan v. U.S. Postal Serv. , 546 U.S. 481 (2006)

................................ ..................... 21 Howard v. FAA , 17 F.3d 1213 (9th Cir. 1994)

................................ ........................ 25 Hynson, Westcott & Dunning, Inc. v. Richardson , 461 F.2d 215 (4th Cir. 1972)

................................ ................................ ................................ ........ 6 Legal Envtl. Assistance Found., Inc. v. EPA , 118 F.3d 1467 (11th Cir. 1997)

....... 20 Motor Vehicle Mfrs’ Ass’n v. State Farm Mut. Auto. Ins. Co ., 463 U.S. 29 (1983)

................................ ................................ ............................... 23 Nat’l Corn Growers Ass’n v. EPA , 613 F.3d 266 (D.C. Cir. 2010)

........................ 25 Nw. Coal. for Alternatives to Pesticides v. EPA , 544 F.3d 1043 (9th Cir. 2008)

................................ ................................ ............................... 22, 23 Pactra Indus., Inc. v. Consumer Prod. Safety Comm’n, 555 F.2d 677 (9th Cir. 1977)

................................ ................................ ................... 3, 4, 7, 13, 17 Public Employees Ret. Sys. of Ohio v. Betts , 492 U.S. 158 (1989)

......................... 20 Rest repo v. McElroy , 369 F.3d 627 (2d Cir. 2004)

................................ ................. 25 Rodriguez v. City of New York , 72 F.3d 1051 (2d Cir. 1995)

........................... 15, 16 Rogers Corp. v. EPA , 275 F.3d 1096 (D.C. Cir. 2002)

................................ ........... 12 Scholastic, Inc. v. Harris , 259 F.3d 73 (2d Cir. 2001)

................................ ............ 15 SmithKline Corp. v. Food & Dr ug Admin ., 587 F.2d 1107 (D.C. Cir. 1978)

......... 14 Snell v. Apfel , 177 F.3d 128 (2d Cir. 1999)

................................ ...................... 16, 17 U.S. v. L.A. Tucker Truck Lines, Inc. , 344 U.S. 33 (1952)

................................ ...... 25 Weinberger v. Hynson, Westcott & Dunning, Inc. , 412 U.S. 609 (1973)

......... 3, 4, 8iv Statutes 21 U.S.C. § 346a(b)(2)(A)

................................ ................................ ....................... 21 21 U.S.C. § 346a(b)(2)(A)(ii)

................................ ................................ .................. 19 21 U.S.C. § 346a(b)(2)(C)

................................ ................................ .... 18, 19, 20, 22 21 U.S.C. § 346a(g)(2)(B)

................................ ................................ ..................... 2, 7 21 U.S.C. § 346a(p)

................................ ................................ ................................ . 18 21 U.S.C. § 346a(p)(2)

................................ ................................ ............................. 18 21 U.S.C. § 346a(p)(3)

................................ ................................ ............................. 18 21 U.S.C. § 371(e)

................................ ................................ ................................ ..... 3 47 U.S.C. § 309(d)(2)

................................ ................................ ................................ . 4 Rules 40 C.F.R. § 178.32(b)

................................ ................................ ..................... 2, 7, 16 40 C.F.R. § 178.32(b)(1)

................................ ................................ ................... 10, 11 40 C.F.R. § 178.32(b)(2)

................................ ....................... 5, 6, 7, 8, 10, 12, 14, 16 40 C.F.R. § 179.83

................................ ................................ ................................ ... 13 40 C.F.R. § 179.83(a)(2)

................................ ................................ .......................... 13 40 C.F.R. § 179.83(b)(2)

................................ ................................ .......................... 13 40 C.F.R. § 179.83(b)(3)

................................ ................................ .......................... 13 Regulations 71 Fed. Reg. 43,906 (Aug. 2, 2006)

................................ ................................ ......... 25 72 Fed. Reg. 39,318 (July 18, 2007)

................................ ................................ ........ 25 73 Fed. Reg. 44,864 (July 31, 2008)

................................ ................................ ........ 24 Other Authorities Fed. R. Civ. P. 26(a)(1)

................................ ................................ ............................ 13 H.R. Rep. No. 104

- 669, Pt. 2 (July 23, 1996)

................................ ................... 19, 211 INTRODUCTION NRDC filed a petition under the Food Act to ban the pesticide dichlorvos because of its risks to human health. EPA denied the petition by relying on an intentional human dosing study that was funded by the pesticide’s manufacturer and involved six test subjects. NRDC requested an evidentia ry hearing to challenge the statistical validity of that study and the adequacy of the study’s informed c onsent process. Both issues involve disputed questions of material fact , and NRDC was entitled to an evidentiary hearing under the summary judgment

li ke standard set forth in EPA’s regulations. EPA arbitrarily denied NRDC’s hearing request . In its opposition brief, the agency defend s itself largely by arguing that it disagree s about the facts . B ut EPA
cannot refuse a hearing by prejudging the proffe red evidence. EPA also disparages NRDC’s submission in support of a hearing, claiming that it amounts to “no evidence” at all. However, NRDC submitted peer

- reviewed scientific articles, published essays and analyses , and written comments identifying spec ific deficiencies in the dichlorvos human experiment

. This evidence was more than sufficient to identify material issue s of fact in dispute and justify a hearing

. EPA’s refusal to hold a hearing violates the statute and the agency’s regulations. In addit ion, EPA violated the Food Act by refusing to apply a required tenfold safety factor in establishing the a cceptable level of dichlorvos exposure for2 children

. This safety factor is required under the law to account for incomplete data about health risks to infants and childr en. EPA waived the safety factor despite admitting that it has never implemented the endocrine testing program mandated by Congress to evaluate the harmful effects of dichlorvos. This violates the statute’s plain language. EPA’s safety factor decision i s also arbitrary and capricious because the agency simply applied its own alternative “default” safety factor of three , instead of ten, without any legitimate basis. The Court should therefore vacate and remand to EPA with instructions to apply the safety factor required by law and conduct an evidentiary hearing on the disputed issues of material fact identified by NRDC

. ARGUMENT
I. NRDC Is Entitled to an Evidentiary Hearing to Resolve Disputed Material Facts

. The Food Act states that EPA “shall” hold an evidentiary hearing “if and to the extent the Administrator determines that such a public hearing is necessary to receive factual evidence relevant to material issues of fact raised by the objections .” 21 U.S.C. § 346a(g)(2)(B)

. Under EPA’s regulations, it must grant a hearing if: (1) t here is a “ genuine and substantial issue of fact,” (2) there is a

“ reasonable possibility that available evidence identified by the requestor would, if established, resolve ” the issue in the requestor’s favor , and (3) the factual issue is “determinative” of the challenged action. 40 C.F.R. § 178.32 (b)

. Only the first3 two requirements ar e at issue here. NRDC established that the factual issues on which it seeks a hearing are “determinative,” NRDC Br. at 25, 30

- 31, and EPA does not dispute the point in its opposition brief.
Courts consistently interpret regulations requiring resolution of a “genuine and substanti al issue of fact” as mandating summary judgment

- like analysis. Weinberger v. Hynson, Westcott & Du n ning, Inc. , 412 U.S. 609, 6 20, 6 22 (1973)

. Under this standard, EPA must grant a hearing if objections “raise material issues that are not frivolous or inconsequential.” Pactra Ind u s., Inc. v. Consumer Prod. Safety Comm’n, 555 F.2d 677, 684 (9 th Cir . 1977) (interpreting the nearly identical language of 21 U.S.C. § 371(e) ). EPA may deny a hearing request only where the objections have been “authoritatively determined” to be “legally irrelevant.” Id

. When objections point out f laws in the challenged agency decision, “ a hearing must be held unless the effort is ‘palpably shallow.’” American Cyanamid Co. v. Food & Drug Admin ., 606 F.2d 1307, 1320 (D.C. Cir. 1979) (internal citation omitted)

. A party requesting a hearing need not make a “fully persuasive case, but rather what a reasonable factfinder might view as a persuasive case

– the quantum, i n other words, that would induce a trial judge to let a case go to the jury even though he himself would (if nothing more were known) find against the plaintiff.” Citizens for Jazz on WRVR, Inc. v. FCC , 775 F.2d 392, 397 (D.C. Cir.4 1985) (emphasis in original) (interpreting the analogous language of 47 U.S.C. § 309(d)(2) ). EPA declares that the Court must be “ extremely deferential ” when reviewing “technical matters. ” EPA Br. at 29

- 30. However, courts do not apply the heightened deference accorded to technical matters when evaluating an agency’s denial of an eviden tiary hearing. The sufficiency of an evidentiary proffer is a legal question that courts can readily evaluate. See Weinberger , 412 U.S. at 622 (when reviewing an agency order denying an evidentiar y hearing, “a court of appeals must determine whether the [agency’s] findings accurately reflect” the record) . This question can be resolved by asking whether the factual evidence adduced by NRDC is “palpably shallow,” American Cyanamid , 606 F.2d at 1320 , or “frivolous or inconsequential,” Pactra , 555 F.2d at 684

. EPA concedes that its hearing regulations create a procedure analogous to
summary judgment. SPA 48. But in denying NRDC’s hearing request , EPA did not apply anything resembling a summary judgment standard . Rather than grant a hearing once NRDC established a “genuine and substantial issue of fact” in dispute, EPA insist ed that NRDC mu st conclusively establish the ultimate facts that a hearing is intended to determine

. EPA also improperly prejudged the evidence proffered by NRDC and denied a hearing based on the agency’s contrary5 opinion about the facts. The result was to deprive NRDC of its statutory right to review by a neutral factfinder

. A

. NRDC Identified a Material Issue of Fact Regarding the Statistical Power of the Dichlorvos Human Study

. NRDC requested an evidentiary hearing to contest the statistical validity of the dichlorv os human experiment , in which six subjects ingested dichlorvos once a day for 21 days

. A 259

- 62 ; A 9

. NRDC asserted in its objections that this study was statistically invalid because six subjects were far too few to identify either the harmful health ef fects from dichlorvos exposure or the dose at which those health effects would occur. A 250, 259

- 62. In support, NRDC submitted a published, peer

- r eviewed criticism of the study, A 267 , an article and letter from an environmental science journal identifyi ng the st udy’s statistical deficiencies, A 264, 265 , written comments from an NRDC scientist regarding the minimum required sample size for any human study, A 284 , and a published essay by a neurologist stating that a test with six subjects lacks statistic al valid ity , A 276

. This exceeds the necessary showing required to justify a hearing ; t his proffer raise s a genuine and substantial issue of
f

act that satisf ies 40 C.F.R. § 178 .32(b)(2) and would merit submission to a jury under a summary judgment test

.6 1. EPA improperly refused to hold a hearing because it disagrees about the facts in dispute

. EPA first defends its hearing denial by asserting that, in the agency’s view, the dic hlorvos human experiment was “sufficiently robust” to support the agency’s decision. EPA Br. at 20, 38

- 39

. However, EPA may not deny a hearing because it disputes the factual conclusions that a hearing is intended to determine

. A hearing must be granted if there is “any ‘genuine and substantial’ evidence that supports the position of the applicant .” Hynson, Westcott & Dunning , Inc. v. Richardson , 461 F.2d 215, 220 (4th Cir. 1972) . “Manifestly, the applicant does not have to satisfy or convince the [agency] by his evidence . . . as a predicate for securing his right to a hearing.” Id . Requiring the agency to be convinced by the evidence makes the hearing requirement in the law “purely illusory.” Id

. EPA’s regulation s direct that a hearing reque st must be granted if t here is a

“ reasonable possibility that available evidence identified by the requestor would, if established , resolve one or more ” disputed issues in the requestor’s favor. 40 C.F.R. § 178.32(b)(2) (emphasis added). EPA disregards this language by demanding that the evidence submitted in support of a hearing fully establish NRDC’s factual position to the agency’s satisfaction

. EPA is predictably disinclined to reverse its own conclusions in respon se to NRDC’s objections, but the evidentiary hearing provision in the Food Act creates a safeguard that requires a neutral factfinder to resolve genuine issues of disputed fact. 21 U.S.C.7 § 346a(g)(2)(B)

. An agency ma y not refuse a hearing “merely because the agency has concluded that the scientific evidence is adequate to support its order.” Pactra , 555 F.2d at 684

. EPA wrongly denied NRDC’s right to an evidentiary hearing under the law based on EPA’s disagreement about the facts

. Applying EPA’s improper standard would mean that no party would ever be entitled to a hearing, because the agency could deny a hearing whenever it disagrees about the facts in d ispute. Indeed, EPA has never permitted an evidentiary hearing under the Food Act for any pesticide , in the nearly four

- decade history of the law. SPA 64. This violates the statute and EPA’s regulations, which state that EPA must hold a hearing to dete rmine genuine issues of fact in dispute. 21 U.S.C. § 346a(g)(2)(B) ; 40 C.F.R. § 178.32(b)

. 2. NRDC submitted specific evidence challenging the statistical deficiencies in the dichlorvos human study

. EPA next asserts that NRDC submitted “no evidence” regarding the study’s statistical validity, and instead made only general allegations. EPA Br. at 25

- 26. Under the regulations, a hearing will not be granted on the basis of a “general des cr iption of positions ” alone. 40 C.F.R. § 178.32(b)(2) . EPA seizes on the word “general” and repeats it in its brief , claiming that NRDC’s evidence amounts to only “generalized conclusions,” “generalized criticism,” “g eneral criticism,” and “general science/policy criticisms” that “generally discuss[]” statistical power.
EPA Br. at 41

- 43. EPA’s mischaracterization distorts the record evidence.8 NRDC’s objections identify and attach specific evidence that critique s th e statistical validity of the particular study at issue here , including published essays, letters, a scientific journal article, and technical comments . A 264

- 76, 286

- 89

. This is more than the “general description of positions” deemed inadequate under th e regulations

. 40 C.F.R. § 178.32(b)(2)

. T he Supreme Court has previously found that “ a list of literature references, a copy of an unpublished study, and a representative sample testimonial letter ” were “ sufficient to warrant a hearing .” Weinberger , 412 U.S. at 615, 623

. EPA overreaches when it claims that NRDC submitted “no evidence” on the question of statis tical power. EPA Br. at 25

- 26.
3. NRDC identified a material dispute of fact about the statistical validity of the dichlorvos study

. EPA also argues that NRDC’s objections are not material, because, in the agency’s view, NRDC failed to respond to EPA’s competing factual conclusions about the study’s stat istical power. EPA Br. at 26 , 40 . This also mischaracterizes the record , which shows that NRDC did take issue with EPA’s conclusions regarding statistical validity:

a. EPA claimed that the use of six human subjects was acceptable because a p ositive response was seen. A 224 . NRDC responded that six test subjects were too few to extrapolate to t he general human population. A 260, 264. b. EPA claimed that the small number of human subjects was acceptable because it exceeds the number of animals used in a diff erent pesticide test9 conducted on dogs. A 224. NRDC responded that the dog study actually uses more than six total subjects, and that the dog study itself is also statisti cally suspect. A 260.

c. EPA claimed that the dichlorvos study’s use of only male s ubjects was acceptable because no sex differences have been observed in animal studies.
A 224 . NRDC responded that human males are biologically unrepresentative of pregnant women, infants, and children, A 261, that the results from a study

c onduct ed on adults on ly cannot be generalized to children, A 271, and that studies limited to healthy adult males have questionable scientific value, A 298. d. EPA claimed that the study identified changes in the cholinesterase levels in test subjects. A 224. NRDC responded t hat this may not be a meaningful result because cholinesterase levels in humans are highly variable , both in individuals over time and between individuals. A 2 60

- 61. EPA is therefore wrong that NRDC’s objections failed to respond to the positions stated in EPA’s petition denial. Finally, EPA claims that the statistical power of the dichlorvos human study is immaterial because the study did identify an effect (the inhibition of acetyl cholinesterase , or “ AChE ” ). EPA Br. at 25, 43. This ignores that the p esticide may cause harmful effects other than the ones the study was looking for, such as behavioral impacts, which a larger sample size could have revealed. A 265, 271 ,10 284 ; NRDC Br. at 26

- 27

. EPA claims that this argument was waived, EPA Br. at
44

- 45, but it is clearly presented in the administrative record. 1 NRDC adequately identified a “ genuin e and substantial issue of fact ” about the statistical validity of the dichlorvos human study, and there is a “ reasonable possibility ” that the cited evidence wo uld, if established, resolve the issue in
NRDC’s favor

. 40 C.F.R. § § 178.32 (b) (1)

- (2)

. If the study were not statistically valid, EPA could not re ly on it, thus depriving the agency of the crucial scientific basis for its approval of the pesticide. See SPA 57 ( conceding that EPA approved dichlorvos only after relying on the human study to weaken the safe exposure level ). NRDC is therefore entitled to a hearing to develop the facts and present them to a neutral factfinder for decision.

1 Specifically, NRDC’s submission asserted: “ [ T ] he investigators focused their statistical evaluations on red cell and plasma AChE activity . . . . How ever, . . . few protocols used rigorous methods to collect and evaluate any data other than AChE activity . Thus, it is not clear how they justified the [no observed effects] conclusion.” A 271 (emphasis added). NRDC also argued: “The calcul ated statistical power . . . had a one

- in

- five chance of detecting an effect if it were present, practically guaranteeing a finding of no effect.

. . . [T]he outcome measures in the industry studies were peripheral red blood cell acetyl cholinesterase (AC hE) levels . . . . The insensitivity of these measures stands in contras t with recent literature on low

- dose noncholinergic toxic effects

. . . , including effects on neurogenesis and behavior .” A 265 (emphasis added and internal citations omitted); see also A 266 (identifying several non

- cholinergic effects of concern, including behavioral changes).11 B

. NRDC Identified a Material Issue of Fact Regarding Whether the Dichlorvos Human Study Establish ed Informed Consent

. NRDC also requested a hearing to determine wh ether the dichlorvos human study adequately obtained the informed consent of the test subjects. A 250, 261

- 62. In support, NRDC cited an EPA staff memo stating that the study investigators “may well have misled subjects” about the risks involved, A 261

- 6 2 , A 3

- 5 , a draft report from an EPA advisory panel (the Human Studies Review Board) concluding that the dichlorvos study “failed to fully meet the standards” of informed consent,
A 259, A 40

- 41 , and a published critique of the study identifying “defici enc ies in the consent documents ” presente d to the experimental subjects, A 271. NRDC proffered sufficient evidence to warrant a hearing on informed consent

. 1. In order to justify a hearing, NRDC need only establish a disputed fact ual issue , not conclusively resolve the dispute

. EPA justifies its hearing denial by citing evidence that it believes supports its reliance on the human study , including competing statements by the Human Studies Review Board. EPA Br. at 49

- 50 (quoting A 41). However, EPA’s eviden ce only demonstrates the need for a hearing by illustrating the dispute d issue of fact. See 40 C.F.R. § 178.32 (b)(1) (hearing appropriate when there is a substantial issue of fact for resolution)

. NRDC is not required to establish conclusively the very facts that a hearing is intended to determine

. Instead, the regulations require NRDC to show a12 “reasonable possibility” that the submitted evidence, “if established,” would resolve the i ssues in NRDC’s favor. Id . § 178.32(b)(2)

. The D.C. Circuit vacated an agency’s decision to deny an evidentiary hearing in Citizens for Jazz in analogous circumstances, holding that “[i]t would be peculiar to require, as a precondition for a hearing, that the petitioner fully establish . . . what it is the very purpose of the hearing to inquire into.” 775 F.2d at 397

. “ The statute in effect says that the [agency] must look into the possible existence of a fire only when it is shown a good deal of smoke; the [agency] has said that it will look into the possible existence of a fire only when it is shown the existence of a fire.” Id

. ; see also Roger s Corp. v. EPA , 275 F.3d 1096, 1105 (D.C. Cir. 2002) ( holding that an administrative decision in the nature of summary judgment “is inap propriate when there is a disputed issue of material fact giving rise to conflicting inferences and a choice among them would amount to fact finding” ). Furthermore, EPA exaggerates the strength of the evidence on its side of the dispute. The Human Studies Review Board concluded that “the written documentation for inform ed consent failed to fully meet” applicable standards.
A 40. The Board was clear that it would offer only “tepid endorsement” of EPA’s use of the study, A 25, and that the design of the di chlorvos human study “was not defensible scientifically. ” A 36

. EPA thus overstates the case by arguing, based on this language, that the Board considered and rejected NRDC’s arguments.13 EPA Br. at 20. Given that the agency’s own evidence is so equivoca l on the question of informed consent, EPA may not properly conclude that NRDC’s contrary factual argument is “ frivolous or inconsequential,” Pactra, 555 F.2d at
684 , or “ palpably shallow,” Ame rican Cyanamid , 606 F.2d at 1320 . NRDC was therefore entitled to a hearing. EPA’s hearing regulations further underscore the agency’s error. The regulations require the parties to develop the facts during a hearing , through a discovery

- type proceeding analogous to initial disclosures under Fed. R. Civ. P. 26(a)(1)

. See 40 C.F.R. § 179.83

. Specifically, o nce a hearing is underway, the parties must submit all documents in their possession “ containing factual information or expert opinion, whether favorable or unfavorable ,” that relate to the issues involved in the hearing

. Id

. § § 179.83(a)(2) , 179.83(b)(2)

- (3) . These

re gulations defeat EPA’s claim that all evidence must be submitted at the outset, before a party is even entitled to a hearing. It is improper to “deny a petitioner the opportunity to elicit in discovery and cross

- examination the further facts necessary
to elevate its case from one which merely raises a serious question ” of disputed fact “to one which establishes it.” Citizens for Jazz , 775 F.2d at 395

. T o the extent EPA’s final decision on dichlorvos turn s on technical details, allowing NRDC to develop the administrative record through an evidentiary hearing is especially appropriate. See SmithK line Corp. v. Food & Drug Admin .,14 587 F.2d 1107, 1119 (D.C. Cir. 1978) (“To decide the scientific merit of these disputes, on the basis of the record now before us [without hearing], would certainly be to risk the dangerous unreliability likely to occur when ‘technically illiterate judges’ attempt substantively to review mathematical and scientific questions.”) (internal citation omitted). By denying a hearing based on the existence of competing facts, EPA improperly deprived NRDC of the statutory right to present its evidence to a neutral factfinder. EPA responds that NRDC’s “desire for a neutral arbiter” does not justify a hearing. EPA Br. at 49 n.8. This is an admission that EPA did not review the evidence neutrally, and does not bel ieve that it is required to, which is inconsistent with the summary judgment

- like standard the agency admits it must apply

. If “reasonable minds could differ,” summary judgment is inappropriate. Anderson v. Liberty Lobby, Inc. , 47 7 U.S. 242, 250 (1986) ; see also 40 C.F.R. § 178.32(b)(2) ( a hearing is required if there is a “reasonable possibility” that the proffered evidence would resolve the issue in the requestor’s favor)

. 2. EPA improperly denied NRDC’s hearing request by claiming that there was no factual dispute to be resolved

. EPA argues that NRDC frames the issue of informed consent as a “legal” question a nd not a factual one, and thus NRDC is not entitled to a hearing

. EPA Opp. at 47. This is false; NRDC identified the informed consent issue as a factual question. See A 260 (“[T]he Gledhill DDVP human study

. . . failed to obtain full y15 informed and volu ntary consent.”); A 261 (“[T]he description of DDVP as a ‘drug’ can hardly be said to convey an accurate picture of a neurotoxic pesticide.”); A271 (“[D]eficiencies in the consent documents (e.g., failure to identify the test compound as a pesticide) . . . raise serious doubts as to whether the participants’ signatures were a reasonable reflection of informed voluntary consent.”). EPA also ignores the cases cited by NRDC holding that the existence of informed consent is a question of fact. NRDC Br. at 29, 31.
EPA further argues that there are no disputed facts regarding informed consent because the consent forms themselves are not disputed. EPA Br. at 47. However, evidentiary hearings are routinely conducted to determine the meaning of a document (say, a contract) when the text of the document itself is undisputed. See, e.g. , Scholastic , Inc. v. Harris , 259 F.3d 73, 82 (2d Cir. 2001) (the meaning of

an ambiguous contract is a question of fact for a factfinder) . “I t is not the province of the summary judgment court itself to decide what inferences should be drawn.” Chambers v. TRM Copy C tr s . Corp ., 43 F.3d 29, 38 (2d Cir. 1994)

. EPA may not grant itself summary judgment “ when there exist disputes as to related facts that would permit competing inferences to be drawn as to the meanings of the undisputed events.” Rodriguez v. City of New York , 72 F.3d 1051, 1064 (2d Cir. 1995)

. NRDC is entitled to present evidence to an administ rative law judge to16 demonstrate that the human study’s consent forms were inadequate to obtain the voluntary and informed consent of the test subjects

. 3. EPA set the bar too high to demonstrate a disputed issue of fact regarding informed consent

. In its reply brief, E PA argues for the first time that expert testimony is the

“ minimum ” evidentiary submission necessary to create an issue of fact about informed consent, citing Rodriguez v. City of New York , 72 F.3d at 1063 . EPA Br.
at 47. First, EPA never made this argument below, and the Court should therefore disregard it. Snell v. Apfel , 177 F.3d 128, 134 (2d Cir. 1999) ( “A reviewing c ourt

m ay not accept appellate counsel’ s post hoc rationalizations for agency action.” ) (internal quotation omitted). Second, EPA mischaracterizes Rodriguez . That case held only that the competing expert testimony offered by the opposing parties there

cre ated an issue of fact; it did not hold that expert testimony is the minimum showing necessary . Rodriguez , 72 F.3d at 1064 (finding that “it was beyond the province of the court on a motion for summary judgmen t to d ecide between the experts’ competing testimony” )

. Third, EPA’s regulations nowhere require submission of expert testimony in order to justify a hearing, see 40 C

. F

. R

. § 178.32(b) , and EPA cannot raise the bar higher than is se t in its regulations. Admittedly, t here is a legitimate concern about not setting the bar too low ; a requestor should not be entitled to a hearing based on a trivial submission or “mere allegations” alone

. I d . § 178.32(b)(2)

. But granting NRDC a hearing here would17 not open the floodgates to undeserving requestors

. To justify a hearing on the question of informed consent, NRDC submitted specific evidence identifying a legitimate factual dispute, including an int ernal EPA memo stating that the human study may have misled the test subjects , A 261, A 3

- 5 , an advisory panel report concluding that the study “failed to fully meet the standards” of informed consent,
A 259, A 40

- 41 , and a published critique of the st udy identifying “deficiencies in the consent documents

. ” A 271

. This clearly exceeds the threshold established in EPA’s regulations and in the caselaw

. NRDC’s evidentiary proffer is neither

“ frivolous or inconsequential,” Pactra, 555 F.2d at 684 , n or “ palpably shallow,” American Cyanamid , 606 F.2d at 1320

. 2
NRDC is therefore entitled to a hearing to resolve disputed issues of fact regarding the in formed consent process in the dichlorvos human study.
II. EPA Unlawfully Waived the Children’s Safety Factor Required by Law

. EPA does not have reliable data to depart from the required children’s safety factor for dichlorvos because the agency has neve r conducted the endocrine testing

2 EPA’s counsel offers another new theory not advanced below: that the peer

reviewed article cited by NRDC in support of its hearing request (A 267) is unrel iable because the author, Dr. Lockwood, purportedly did not review the consent forms from the dichlorvos human study. EPA Br. at 48, 50. The Court should disregard this argument because the agency never made it during the administrative proceedings. See Snell , 177 F.3d at 134 . If it had, NRDC could have supplemented the record (to the extent it is not clear) to establish that Dr. Lockwood did, in fact, review the dichlorvos study consent forms.18 required by statute to identify harmful health effects to children

. 21 U.S.C. § § 346a (b)(2)(C) , 3 46a (p)

. EPA’s safety factor decision is therefore contrary to law.
A. The Food Act Prohibits EPA from Waiving the Children’s Safety Factor in the Absence of Required Data

. The Food Act mandates that “an additional tenfold margin of safety . . . shall be applied for infants and children to take into account potential pre

- and post

natal toxicity and completeness of the data with respect to exposure and toxicity to infants and children.” Id . § 346a(b)(2)(C) (e mphasis added)

. The Food Act also directs EPA to develop a testing program to evaluate the endocrine disruption effects of pesticides

. I d . § 346a(p)

. The statute directs that “all pesticide chemicals” “shall” be tested pur suant to the endocrine disruption program by no later than 1999. Id . §§ 346a(p)(2) & (3)

. Congress added these two provi sions to the statute at the same time

– section 346a(p) to require EPA to develop research data on harmful endocrine effects, and section 346a(b)(2)(C) to order EPA to apply a tenfold saf ety factor to account for incomplete data on health risks to children. EPA concedes that it has never tested dichlorvos (or any other pesticide) under this program. EPA Br. at 56 (admitting “the absence of results from the screening program”)

. Yet EPA wa ived the tenfold safety factor required by Congress for precisely these circumstances: to account for incomplete data19 regarding toxicity to children. 21 U.S.C. § 346a(b)(2)(C)

. This decision violates the statute’s pla in language. EPA argues that it has discretion to reduce or eliminate the children’s safety factor, as it did here. EPA Br. at 55

. 3 The Food Act does permit EPA to apply a different margin of safety , but “ only if , on the basis of reliable data, such marg in will be safe for infants and children.” 21 U.S.C. § 346a(b)(2)(C) (emphasis added). The word “ safe ” is defined to mean “a reasonable certainty that no harm will result.” Id . § 346a(b)(2)(A)(ii)

. Where studies identified by Congress as necessary to ensure safety have never been conducted, EPA by definition cannot find that there is a “reasonable certainty” that “no harm will result” to children. Id

. EPA ignores the relevant legislative history, which further illustrates the point:

“ When data relating to infants and children are incomplete , and also to account for potential pre

- and post

- natal t oxicity, the Administrator is to apply . . . an additional tenfold margin of safety for infants and children.” SPA 34 ( H.R. Rep. No. 104

- 669, Pt. 2 , at 43 ( July 23, 1996 ) (emphasis added) )

. EP A admits that it has never tested dichlorvos under the statutory endocrine screening program. EPA Br. at 56

. But the agency argues that other data “provide valuable information on potential endocrine effects” and permit EPA to ignore the

3 EPA repeatedly cites to “21 U.S.C. § 346a(a)(2)(C)” in it s reply brief. EPA Br. at 55. There is no such section in the law. EPA is apparently referring to 21 U.S.C. § 346a(b)(2)(C).20 missing studies and reduce the children’s safety factor. EPA Br. at 54 n.10

. This is misdirection; whatever “valuable information” EPA derives from other research , EPA nowhere claims that those studies substitute for or investigate the same health effects as the endocri ne research required by Congress. To the contrary , the alternative studies to which EPA refers have been required for all pesticides since 1984. EPA Br. at 10. There would have been no reason for Congress to amend the statute to require additional re search on endocrine disruption if these pre

- existing studies already provided satisfactory data on the same health risks. EPA concedes that the data are incomplete, EPA Br. at 56, and the Food Act requires that the tenfold safety factor “ shall be applied for infants and children ” to account for incomplete data “ with respect to exposure and toxicity to infants and children.” 21 U.S.C. § 346a(b)(2)(C)

. EPA protests that it “has consistently interpreted the statute” to let it ignore congressionally

- mandated study requirements, EPA Br. at 55, but that is irrelevant. As the Supreme Court has held, “of course, no deference is due to agency interpretations at odds with the plain language of the statute itself. Even contemp oraneous and longstanding agency interpretations must fall to the extent they conflict with statutory language.” Public Employees Ret. Sys. of Ohio v.
Betts , 492 U.S. 158, 171 (1989) ; see also Legal Envtl. Assistance Found., Inc. v.
EPA , 118 F.3d 1467, 1477 (11th Cir. 1997) (rejecting EPA’s argument that its21 statutory interpretation is “entitled to special deference because it has been consistent over a long time period”). Finally, EPA’s interpretation is contrary to congressional purpose. The Food Act is a purely health

- protective statute; the only relevant factor in evaluating a pesticide under the law is whether it is “safe,” which requires a finding of “reasonable certainty” that “no harm will result

. ” 21 U.S.C. § 346a(b)(2)(A) . The Food Act was comprehensively amended in 1996 to require a tenfold children’s safety factor in the face of uncertainty ; Congress’s clear and stated purpose in adding this safety factor w as to protect infants and children from unknown risks of pesticide exposure in the absence of complete information. SPA 34 ( H.R. Rep. No. 104

- 669, Pt. 2, at 43 ). In spite of this, EPA’s interpretation give s the age ncy complete authority both to disregard health effects research ordered by Congress ( as EPA has done for more than a decade ) , and at the same time dismiss the safety factor expressly meant to account for incomplete data

. The result is to increase health risks to children. The Court should reject EPA’s argument because it is contrary to both the plain text and purpose of the Food Act. See Dolan v. U.S. Postal Serv. , 546 U.S. 481, 486 (2006) (courts must construe statutory language in light of “the purpose and context of the statute”)

.22 B. EPA Failed to Provide a Reasoned Basis for its Safety Factor Decision

. EPA also arbitrarily reduced the children’s safety fa ctor from ten to three without providing any rational explanation

. NRDC Br. at 7, 37

- 39. EPA admitted in its denial order that it applied a threefold safety factor because that is its “default” practice when it chooses to reduce the safety factor but doe s not want to eliminate it entirely. SPA 50 (“Generally, EPA uses a 3X safety factor as the default value when reducing a 10X safety factor.”)

. According to EPA, “where a 10X factor would clearly overstate the uncertainty, EPA simply applies a factor val ued at half of 10X.” SPA 50. This is unlawful ; EPA may use a margin of safety different from the statutory default level “only if, on the basis of reliable data , such margin will be safe.” 21 U.S.C. § 346a(b)(2)(C) (e mphasis added)

. EPA’s “default” reliance on a threefold instead of tenfold safety factor has already been rejected by the Ninth Circuit. Nw. Coal. for Alternatives to Pesticides v. EPA , 544 F.3d 1043, 1052 (9th Cir. 2008) (“ [ I ] t appears that the EPA chose these lower safety levels arbitrarily

– to acknowledge certain concerns about each pesticide, but with no specific evidence that these lower safety factors would actually account for the r isks to infants and children.”). EPA’s continued use of its own “default” threefold safety factor is arbitrary because it fails to “demonstrate a rational connection between23 the factors that the EPA examined and the conclusions it reached.” Id

. (citing Motor Vehicle Mfrs’ Ass’n v. State Farm Mut. Auto. Ins. Co ., 463 U.S. 29, 43 (1983) )

. EPA claims that results from the dichlorvos human study justify its use of a threefold safety factor. EPA Br. at 58

- 60 . But EPA nowhere argues that that study showed children to be only three times more sensitive to dichlorvos exposure than adults

. Nor could it have; the study was conducted on a d ults only

. A 9, 261. The human study is therefore irrelevant to the children’s safety factor decision. 4
Because EPA based its choice of a threefold safety factor for dichlorvos on its general default practice, not on any relevant data regarding health risks to children , the agency’s decision was arbitrary and irrational.
C

. NRDC Did Not Waive this Challenge to EPA’s Unlawful Safety Factor Decision

. EPA claims that NRDC waived this challenge to the agency’s safety factor decision by raising it only in the objections, not in the original petition. EPA is
wrong.

4 EPA declares that this particular argument was waived. EPA Br. at 63. It was not; NRDC expressly argued that EPA could not r ely on the dichlorvos human study to set the safe exposure level for children because the study used only adult subjects. A 261 (adult test subjects are “biologically unrepresentative” of infants and children). EPA later admits that NRDC presented this a rgument below, stating that “EPA specifically rejected NRDC’s argument that the Gledhill study’s use of adult subjects only made it ‘invalid for use by EPA to set exposure standards for a diverse population.’” EPA Br. at 64 (quoting NRDC’s objections at A 260).24 NRDC made this argum ent both in its petition (A 56, 70) and in the subsequent objections (A 252

- 53 ). NRDC’s petition challenged “ EPA’s failure to apply the full FQPA tenfold safety factor ” in part because of an “absence of reliable data.” A 56. In a list of examples of mi ssing data, the petition argued that EPA had not completed the required endocrine screening program and, as a result,

“ EPA cannot conclude that the DDVP registrations will not cause unreasonable adverse effects or that the associated tolerances are safe .” A 70. In response , EPA rejected the argument “that data gathered under the Endocrine Disruptor Screening Program (‘EDSP’ ) is a prerequisite to a safety determination

. ” A 225. EP A also acknowledged that NRDC raised this argument in its petition and that the agency responded, stating : “ EPA concluded in the petition denial that . . . EPA had sufficient reliable data on DDVP’s potential endocrine effects to vary from the default children’s safety factor. ” SPA 64. NRDC adequately made this argument at both stages of the petition and objection process. 5

5 EPA contradicts its waiver argument elsewhere in its brief, by criticizing NRDC for reiterating the same claims in both the petition and the objections. Much of EPA’s criticism is gratuitous, because it refers to arguments that are not at issue in t his appeal. EPA Br. at 3 n.2. In any event, NRDC presented the same arguments in both the petition and the objections because EPA requires as much; otherwise, EPA has declared (as it attempts to now) that an argument is waived. See , e.g. , 73 Fed. Reg. 44,864, 44,865 (July 31, 2008) . EPA’s position amounts to a Catch

- 22: objections are either immaterial if they were previously raised in the petition or waived if they were not. According to EPA, NRDC’s arguments are either too early or too late.25 Furthermore , there can be no waiver when the agency fully considered an issue during the administrative process. Restrepo v. McElroy , 369 F.3d 627,
633 n.10 (2d Cir. 2004) (exhaustion requirements are satisfied when the agency considered and addressed an argument below). The point of the waiver doctrine is to allow agencies the “opportunity for correction” prior to judi cial review. U.S. v. L.A. Tucker Truck Lines , Inc. , 344 U.S. 33, 37 (1952) . When an agency does “pass on the merits of [petitioner’s] cla im, the purposes behind the exhaustion requirement have been satisfied.” Howard v. FAA , 17 F .3d 1213, 1217 (9th Cir. 1994)

. EPA fully considered and rejected the endocrine tes ting issue in its final denial order. SPA 50

- 51

. EPA argue s that “the court will not consider an argument the agency was not given a fair opportunity to consider during the rulemaking.” EPA Br. at 53 ( q uoting Nat’l Corn Growers Ass’n v. EPA , 613 F.3d 26 6 , 2 73 (D.C. Cir. 2010 ) )

. Here, however, EPA not only had a fair opportunity to consider the argument during the rulemaking, it did in fact consider (and reject) the argument during the rulemaking. SPA 50

- 51. Finally , EPA has denied NRDC’s endocrine disruption argument in two prior orders as well

. See 72 Fed. Reg. 39,318, 39,327

- 28 (July 18, 2007) ; 71 Fed. Reg. 43,906, 43 , 920

- 21 (Aug. 2, 2006)

. Thus, EPA has now rejected this argument three separate times , as the agency admits

. SP A 51 ( “EPA denies this objection for26 the reasons stated in its previous two orders addressing this claim

. ” ). Exhaustion is not required when the agency “has predetermined the issue

. ” Bastek v. Fed

. Crop Ins. Corp. , 145 F.3d 90, 94 (2d Cir. 1998)

. It would serve no purpose to force NRDC to present the argument to EPA again , in a fourth petition. The Court can and should review the claim now. CONCLUSION EPA concluded in 1995 that all residential uses of dichlorvos should be banned because its risks to human health were too severe . A 46. Fifteen years later, the chemical is still on the market because of EPA’s reliance on the dichlorvos human experiment conducted by the pesticide’s manufacturer. SPA 57

. If EPA did not rely on this human study , it would have to ban the pesticide.
SPA 57; NRDC Br. at 25. NRDC is entitled to an evidentiary hearing to determine whether this study is stati stically valid and whether it properly obtained the informed consent of the test subjects. NRDC established a disputed material issue of fact on both questions and submitted specific, detailed evidence in support.
EPA ’s unlawful hearing denial improperly shields the agency’s decision from the scrutiny of an administrative law judge or a court. EPA also violated the law by waiving the required children’s safety factor for dichlorvos , despite never conducting research on harmful endocrine effects that it wa s obligated to complete more than a decade ago

. The Food Act’s plain27 language requires EPA to apply the tenfold safety factor precisely to account for missing data about children ’ s health risks

. The agency further acted arbitrarily by lowering the safet y factor from the statutory default of ten to the agency’s preferred default of three , without a legitimate justification

. Because the agency’s decision is arbitrary, capricious, and contrary to law, the Court should vacate the challenged EPA order and remand with instructions to apply the children’s safety factor and conduct an evidentiary hearing.
Respectfully submitted,

Aaron Colangelo Natural Resources Defense Council 1200 New York Ave., NW, Suite 400 Washington, DC 20005 202

- 289

- 2376 Counsel fo r Petitioner NRDC Dated: December 2, 201028 CERTIFICATE OF COMPLIANCE This brief complies with th e type

- volume limitation of Federal Rule of Appellate Procedure 32(a)(7)(B) because it contains 6, 502 words. This brief complies with the typeface and typ e style requirements of Federal Rules of Appellate Procedure 32(a)(5) and 32(a)(6) because it is written in a proportionally spaced typeface in 14 point font.

/s/ Aaron Colangelo Aaron Colangelo29 PROOF OF SERVICE I hereby certify that I served t wo cop ies of petitioner NRDC’s reply brief by

e - mail and FedEx delivery to counsel for respondent EPA at the address below, on this date, December 2, 2010:
Kent Hanson U.S. Department of Justice Environment & Natural Resources Division Environmental D efense Section 601 D Street NW, Suite 8000 Washington, DC 20004
/s/ Aaron Colangelo Aaron Colangelo