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SETTLEMENT AGREEMENT

 This Settlement Agreement is entered into by and between the Natural Resources 

Defense Council, Inc. (“NRDC”) and the U.S. Environmental Protection Agency 

(“EPA”). 

 WHEREAS, EPA issued an order denying NRDC’s objections to pesticide 

tolerances for residues of dichlorovinyl dimethyl phosphate (“DDVP” or “dichlorvos”) in 

foods, which were established by EPA pursuant to section 408 of the Federal Food, Drug, 

and Cosmetic Act (“FFDCA”), 21 U.S.C. § 346a. See Order Denying NRDC’s 

Objections on Remand, 77 Fed. Reg. 54,402 (Sept. 5, 2012) (“Denial Order”); 

 WHEREAS, NRDC filed a petition for review of the Denial Order in the United 

States Court of Appeals for the Second Circuit, Case No. 12-3671-ag; 

 WHEREAS, the Parties wish to settle NRDC’s pending petition for review; 

 WHEREAS, settlement of NRDC’s petition is in the public interest; 

 NOW, THEREFORE, without admission of any issues of fact or law, or waiver of 

any claim or defense, either factual or legal, the Parties agree as follows: 

 1. EPA agrees to re-examine the Reference Doses (RfDs) and PopulationAdjusted Doses (PADs) for dichlorvos for the following risk assessment scenarios – 

short-term incidental oral exposure; short-term, intermediate-term, and long-term dermal 

exposure; and short-term and intermediate-term inhalation exposure – and to revise those 

RfDs and PADs if EPA determines that such revision is appropriate. If EPA determines 

that there are no pesticide uses that produce exposures associated with one or more of the 

risk assessment scenarios described in the prior sentence, EPA will rescind the existing 

RfD and PAD for that risk assessment scenario rather than re-examine and revise, if 
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appropriate, that existing RfD and PAD. EPA will document its re-examination and 

revision, if appropriate, of the dichlorvos RfDs and PADs as specified in Paragraph 3. 

This documentation will include any EPA determinations to rescind existing RfDs and 

PADs for risk assessment scenarios for which there are no longer pesticide uses. 

 2. In re-examining the RfDs and PADs described in Paragraph 1, EPA agrees 

that, if it identifies the study titled Gledhill, A. J. (1997) Dichlorvos: A Single-Blind, 

Placebo Controlled, Randomised Study to Investigate the Effects of Multiple Oral Dosing 

on Erythrocyte Cholinesterase Inhibition in Healthy Male Volunteers (MRID 44248801) 

(“Gledhill study”) as appropriate to support the derivation of any of the RfDs and PADs 

described in Paragraph 1, EPA will determine whether it may rely on the Gledhill study 

under the provisions of 40 C.F.R. Part 26 as amended in 2013 by 78 Fed. Reg. 10,538 

(Feb. 14, 2013), applicable to the study. If in making the determination described in the 

previous sentence, EPA preliminarily decides that EPA is permitted to rely on the 

Gledhill study under the applicable provisions in 40 CFR Part 26, as amended, EPA 

agrees to submit its review of the Gledhill study to the Human Studies Review Board for 

review and comment under 40 C.F.R. § 26.1604(b). 

 3. No later than May 31, 2014, EPA will make publicly available a memorandum 

explaining the results of its re-examination and revision, if appropriate, of the dichlorvos 

RfDs and PADs described in Paragraph 1. Such memorandum will include a discussion 

of any comments on the Gledhill study made by the Human Studies Review Board, if 

EPA submits the study to the Board under Paragraph 2 and then EPA subsequently 

decides to rely on the Gledhill study for the dichlorvos RfDs and PADs described in 
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Paragraph 1. EPA agrees to notify NRDC of the availability of this memorandum on the 

day it is made publicly available. 

 4. No later than 30 days following EPA’s notice to NRDC of the public release of 

the memorandum described in Paragraph 3, and only if EPA has complied with the terms 

of Paragraphs 1, 2, and 3 by the deadline specified in Paragraph 3, NRDC and EPA will, 

in accordance with Rule 42 of the Federal Rules of Appellate Procedure, file a motion 

with the U.S. Court of Appeals for the Second Circuit, requesting that the court dismiss 

with prejudice Case No. 12-3671-ag, each party to bear its own costs. 

 5. If EPA fails to take the actions described in Paragraphs 1, 2, and 3, by the 

deadline specified in Paragraph 3, then NRDC’s sole remedy for EPA’s failure to take the 

actions described in Paragraphs 1, 2, and 3, by the deadline specified in Paragraph 3 will 

be to reinstate Case No. 12-3671-ag. NRDC agrees not to reinstate Case No. 12-3671-ag 

for any reason other than EPA’s failure to take the actions described in Paragraphs 1, 2, 

and 3, by the deadline specified in Paragraph 3. 

 6. The Parties agree that the memorandum described in Paragraph 3 is not a 

response by EPA to NRDC’s petition to revoke dichlorvos tolerances filed with EPA in 

June 2006. See Petition to Revoke Tolerances Established for Dichlorvos, 71 Fed. Reg. 

59,784 (Oct. 11, 2006). The Parties further agree that NRDC’s sole remaining judicial 

remedy to contest EPA’s response to that petition is Case No. 12-3671-ag in the U.S. 

Court of Appeals for the Second Circuit. 

 7. Nothing in this Settlement Agreement shall be construed to limit NRDC’s 

ability to file a new petition with EPA pursuant to 21 U.S.C. § 346a(d) or the 

Administrative Procedure Act, 5 U.S.C. § 551 et seq., concerning the matters described in 
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Paragraph 1 subsequent to EPA’s public release of the memorandum described in 

Paragraph 3 or May 31, 2014, whichever comes first. 

 8. Other than EPA’s agreement in Paragraph 2 to determine whether EPA may 

rely on the Gledhill study under 40 CFR Part 26, as revised, if EPA decides the Gledhill 

study should be relied upon in derivation of the RfDs and PADs described in Paragraph 

1, nothing in this Settlement Agreement shall be construed to limit EPA’s discretion 

under section 408 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 346a, 40 CFR 

Part 26, or general principles of administrative law. 

 9. This is the entire Settlement Agreement between the Parties with respect to the 

NRDC’s petition for review in Case No. 12-3671-ag (2d Cir.). All prior conversations, 

meetings, discussions, drafts, and writings of any kind are specifically superseded by this 

Settlement Agreement and may not be used by the Parties to vary or contest the terms of 

this Settlement Agreement, or as evidence of the Parties’ intent in entering into this 

Settlement Agreement. 

 10. The Parties may agree in writing to modify any provision of this Settlement 

Agreement. 

 11. Nothing in this Settlement Agreement shall be construed to constitute an 

admission of any issue of fact, law, or liability by any of the Parties. Except as expressly 

provided in this Settlement Agreement, none of the Parties waives or relinquishes any 

legal rights, claims, or defenses it may have. 

 12. The undersigned representatives of each Party certify that they are fully 

authorized by the Party or Parties they represent to bind the respective Parties to the 

terms of this Settlement Agreement. This Settlement Agreement may be signed in