SETTLEII+I~NT AGREEMEI'~TT

This Settlement Agreement {"Agreement") is entered into by American Chemistry

Council, Inc. ("ACC") and the United States Environmental Protection Agency ("EFA")

(together, "the Parties").

RECITALS

A. 4n May 8, 2013, EPA issued a final rule entitled, "Data Requirements for Antimicrobial

Pesticides." 78 Fed. Reg.. 26,93b (May 8, 2013) ("Final Rule").

B. On July 3, 2013, ACC filed a petition for review of the Final Rule in American Chemistry

Counczl, lnc. v. Errvironmental Protection Agency, No. 13-1207 (D.C. Cir.).

C. On July 29, 2013, the Parties jointly filed a motion to hold the petition for review in

abeyance in order to pursue settlement discussions. The motion was granted on July 30,

2~ 13, and joint status reports subsequently have been filed pursuant to Court order.

D. This Agreement resolves all issues related to the Final Rule that ACC raised or could

have raised in ACC's petition for review. The Parties have negotiated in good faith and

have determined that the settlemen# of the petition for review without further litigation

and through this Agreement is in the public interest.

AGREEMENT

Within fouz months of this Agreement becoming final pursuant to paragraph 9, EPA shall

post a proposed guidance document called the Antimicrobial Pesticide Use Size Index

{"USI") on the EPA website and take c4mrnent an the~proposed USI for thirty days.

2. EPA shall include in the proposed USI the following descriptsons:

a Direct Food Use: a use is generally considered to be a direct food use if an

antimicrobial pesticide is intended to he directly applied to food (defined for

purposes of the Federal Food, Drug, and Cosmetic Act at 21 U.S.C. § 321{ fl) or

applied to a material or article for the purpose of treating food.

o Indirect Faod Use: a use is generally considered to be an indirect food use if the

use involves application of the antimicrobial pesticide in or on a material or

article that comes into cflntact with food and may result in residues in or on food,

but the use is no# intended for pesticidal treatment of food.

o Nonfood Use: a use is generally considered to be a nonfood use when #here is a

reasonable certainty of no residues in ar on food, for example because the

antiruicrobial pesticide is not expected to come into contact (directly. or indirectly)

with food as a result of its intended use,
EPA may elaborate on these descriptions in the proposed USA either by referencing

specif c uses that fall'into each of these categories or by otherwise further illustrating

what the descriptions mean.

3. EPA s~al~ consider any comments submitted and subsequently post on the EPA website

the. USI with any changes that E~'A deems appropriate within six months of the end of the

thirty-day comment period.

4. Wixhin two years and six months of this Ag~eernent becoming final pursuant to paragraph

9, EPA shall propose a correction to the Final Rule that will make the language of the

Final Rule as it pertains to the 20~ ppb level established in 40 C.F.R. § 158.2230(d)

consistent with the U.S: Food and Drug Administration's uw of that same level by

making clear that the 200 ppb level established in the Final Rule is based on fatal

estunated daily dietary intake, and is not based on the amount 4f residue present on only

a single commodity.

5. Within sixty days of this Agreement becoming final pursuant to paragraph 9, EPA shall

issue an interim guidance document explaining EPA's interpretation of the 2QU ppb level

established in the~Final Rule.

6. The Parkies may, by written mutual agreement, extend the dates in paragraphs 1, 3, 4, and

5 by which actions must be taken to fulfill E~'A's obliga~iflns under this Agreement.

7. If~EPA fulfills the o~tigatior~s described in.pazagraphs 1, 3, 4, and 5 by the dates

described therein, or as modified pursuant ~o paragraph b, the Parties will file a faint

stipulation of dismissal of the petition fax review within 14 calendar days fol3owing

EPA's fulfillment of the last obligation under this Agreement.

8. If E~'A fails to perform the obligations described in pazagraphs 1, 3, 4, and 5 by the dates

described therein, or as modified pursuant to.paragraph 6, ACC ray file a motion to

dissolve the stay of ACC's petition for review, and to request that a briefing schedule be

set. EPA does not waive or iiinit any defense relating to such litigation. This shad he

ACC's only remedy for EPA's failure to fulfill its obligations under this Agreement The

~'arties agree that contempt of court is not an available remedy. under this Agreement.

9. if EPA performs_ the obligations described %n paragraphs 1, 3, 4, and 5 by the dates

descr~hed therein, or as modified pursuant to paragraph b, this Agreement will constitute

a full and final resolution of aTi matters related to the. peritian far, review. ACC agrees to

release, discharge, and covenant not to assert (by way of ilae commencement of an action,

the joinder of~EPA in an existing action, or in any other fashion} any and ail claims,

causes of action, suits or demands Qf any kind whatsoever in law or in equity which they

may have i~ad, or may now or hereafter have, against EPA relating to the Final Rule.

This Agreement becomes final when signed by the Parties.
l0. No provision o£this Agreement shall be interpreted as or constitute a commitment or

requirement that the United States or any of its departments or agencies obligate yr pay

funds in contravention of the Anti-Deficiency Act, 31 U.S.C. § 1341 et seq., or in

.violation of any other statute, law, ox regulation. In the event that sufficient appropriated

funding is not available, ACC's sole and exclusive remedy under this Settlement

Agreement is set forth in paragraph 8. If a lapse in appropriations occurs within sixty

days prior to the deadlines in paragraphs 1, 3, 4, and 5 of this Settlement Agreement, such•

deadlines shall be extended automatically one day for each clay of the Lapse in

appropriations. Nothing in this paragraph shall preclude EPA from seeking an additional

extension through modification of this Agreement pursuant to paragraph 6.

11. Nothing in this Agreement shall be construed to limif ox modify the discretion accorded

to EPA by statute, or~6y generai~principles of administrative law.

12. This Agreement shall not constitute an admission or evidence of any fact, wrongdoing,

misconduct, or liability on the part of the United States, its officers, or any person

affiliated with it.

13. Eaci~ party will bear its own costs of litigation.

14. This Agreement is tlae entire agreement between ACC~and EPA for the issues involved in

this case. All prior~conversatians, meetings, discussions, drafts and writings:of any kind

regarding issues involved in this case are specifically superseded by this Agreement.

15. It is hereby expressly understood end agreed that this Agreement was jointlq drafted by

ACC and EPA. Accordingly, the Partieshereby agree that any and all rules of

construction to the effect that ambiguity is construed against the drafting Party shall be

inapplicable in any dispute concerning the terms, meaning, or interpretation of this

Agreement.

16. The undersigned counsel for ACC and EPA hereby certify that they are duly authorized

to bind t3ieir,clients to the terms of this Agreement.

17. The provisions of this Agreement shall apply to and be binding on the Parties, their

successors and assigns.

18. This Agreement may be signed in counterparts, and such counterpart signatures shall be

• given full force and effect.

FOR PETITIOi~IER AMERICAN C~-iEMISTRY CtJU'NCIL;INC.:
Dated: ~ ~~"~ IS

4 K.JAIN

Assistan eneral Counsel

American Chemistry Council

700 2"`~ Street, NE

Washington, DC 20002

(202) Z49-4212 {phone)

(202} 47$-2538 (fa~c}

komal~ain@americanchemis#ry.com

FOR RESP4ND~NT U.S. ENVIRONMENi'AL PROTECTION AGENCY:

JOHN C. CRtJDEN

Assistant,Attorney General

Environment and Natural Resowces Division

.-- ~

Dated:~~ By'

EP J. TA'~B RT

Environmental D~fense Section

Environment and Natwal Resources Division

LT.S. Department of Justice

P.O. BOX 7b11

Washington, DC 20044

.(202) 514-2617

Rax: (202} 514-8$65

Stephanie. Talbert@usdo j . gov