Case 1:17-cv-02034-TSC Document 59-1 Filed 06/11/21 Page 1 of 55
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF COLUMBIA
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`
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`Case No. 1:17-CV-02034
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`Judge: Honorable Tanya S. Chutkan
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`NATURAL RESOURCES DEFENSE
`COUNCIL,
`
`
`Plaintiff,
`
` v.
`
`MICHAEL REGAN, in his official capacity as
`Administrator of the U.S. Environmental
`Protection Agency, et al.,
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`
`Federal Defendants,
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` and
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`CROPLIFE AMERICA,
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`
`Defendant-Intervenor.
`
`
`MEMORANDUM OF POINTS AND AUTHORITIES IN RESPONSE TO
`PLAINTIFF’S MOTION FOR SUMMARY JUDGMENT AND IN SUPPORT OF
`FEDERAL DEFENDANTS’ CROSS-MOTION FOR VOLUNTARY REMAND
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`Case 1:17-cv-02034-TSC Document 59-1 Filed 06/11/21 Page 2 of 55
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`TABLE OF CONTENTS
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`PAGE
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`INTRODUCTION .......................................................................................................................... 1 
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`STATEMENT OF FACTS ............................................................................................................. 3 
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`I. 
`
`Statutory and Regulatory Background .................................................................................... 3 
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`A.  The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) .................................... 3 
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`B.  The Endangered Species Act (ESA) ........................................................................................ 6 
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`II. 
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`III. 
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`EPA’s Programmatic Efforts to Comply with the ESA ........................................................ 7 
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`Factual and Procedural Background ........................................................................................ 9 
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`A.  Procedural History ...................................................................................................................... 9 
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`B.  Registrants’ Voluntary Cancellation of Product Registrations .......................................... 10 
`
`C.  The Remaining Nine Product Registrations ......................................................................... 11 
`
`SUMMARY OF THE ARGUMENT ........................................................................................... 13 
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`ARGUMENT ................................................................................................................................ 16 
`
`I. 
`
`II. 
`
`Standard of Review. ................................................................................................................. 16 
`
`Remand Is Proper to Allow EPA to Remedy the ESA Defect by Conducting Effects
`Determinations in the First Instance. .................................................................................... 17 
`
`A.  EPA’s Acknowledgment That It Did Not Make ESA Effects Determinations for the
`Nine Product Registrations Provides a Proper Basis to Remand This Action. ................ 17 
`
`B.  Upon Remand, the Court Should Not Impose Deadlines. .................................................. 20 
`
`III.  Vacatur of The Nine Product Registrations Is Not Required or Appropriate During the
`Pendency of Remand. ............................................................................................................. 30 
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`A.  The ESA error here is not so serious that vacatur is compelled. ........................................ 31 
`
`B.  Equitable Considerations Weigh Against Vacatur of the Nine Product Registrations. .. 37 
`
`1.  Dinotefuran: Vacatur of the Three Product Registrations Would Have Significant
`Disruptive Consequences. ................................................................................................... 37 
`
`2.  Acetamiprid: Vacatur of the Six Products Would Be Inequitable Because It Will Not
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`Benefit Listed Species. ........................................................................................................ 40 
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`IV. 
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`Should the Court Vacate, EPA Would No Longer Have an ESA Legal Obligation to
`Conduct Effects Determinations for the Nine Product Registrations. .............................. 43 
`
`CONCLUSION ............................................................................................................................. 44 
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`TABLE OF AUTHORITIES
`CASES PAGE(S)
`Am. Farm Bureau Fed’n v. EPA,
`559 F.3d 512 (D.C. Cir. 2009) .................................................................................................. 42
`Am. Forest Res. Council v. Ashe,
`946 F. Supp. 2d 1 (D.D.C. 2013) .............................................................................................. 17
`Am. Fuel & Petrochemical Mfrs. v. EPA,
`937 F.3d 559 (D.C. Cir. 2019) .............................................................................................. 6, 36
`Allied-Signal, Inc. v. U.S. Nuclear Regul. Comm’n,
` 988 F.2d 146 (D.C. Cir. 1993) ........................................................................................... passim
`B.J. Alan Co. v. ICC,
`897 F.2d 561 (D.C. Cir. 1990) .................................................................................................. 18
`Baystate Med. Ctr. v. Leavitt,
`587 F. Supp. 2d 37 (D.D.C. 2008) ...................................................................................... 22, 23
`N. Carolina v. EPA,
`550 F.3d 1176 (D.C. Cir. 2008) .................................................................................... 20, 36, 41
`Citizens Against Pellissippi Parkway Extension, Inc. v. Mineta,
`375 F.3d 412 (6th Cir. 2004) ..................................................................................................... 16
`City of Oberlin v. Federal Energy Regulatory Comm’n,
`937 F.3d 599 (D.C. Cir. 2019) .................................................................................................. 40
`Cobell v. Babbitt,
`91 F. Supp. 2d 1 (D.D.C. 1999) .......................................................................................... 23, 24
`Cottonwood Law Ctr. v. U.S. Forest Serv.,
`789 F.3d 1075 (9th Cir. 2015) ..................................................................................................... 7
`Ctr. for Biological Diversity v. EPA,
` 861 F.3d 174 (D.C. Cir. 2017) ........................................................................................... passim
`Davis Cty. Solid Waste Mgmt. v. EPA,
`108 F.3d 1454 (D.C. Cir. 1997) ................................................................................................ 42
`Envt'l Def. Fund, Inc. v. EPA,
`898 F.2d 183 (D.C. Cir. 1990) .................................................................................................. 41
`Ethyl Corp. v. Browner,
`989 F.2d 522 (D.C. Cir. 1993) ............................................................................................ 16, 18
`Fed. Power Comm’n v. Idaho Power Co.,
`344 U.S. 17 (1952) .................................................................................................................... 20
`Federal Power Comm’n v. Transcontinental Gas Pipe Line Corp.,
`423 U.S. 326 (1976) .................................................................................................................. 23
`Fertilizer Inst. v. EPA,
`935 F.2d 1303 (D.C. Cir. 1991) .......................................................................................... 30, 37
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`Fox Television Stations, Inc. v. FCC,
`280 F.3d 1027 (D.C. Cir. 2002) ................................................................................................ 31
`Grand Canyon Air Tour Coalition v. FAA,
`154 F.3d 455 (D.C. Cir. 1998) .................................................................................................. 22
`Heartland Reg'l Med. Ctr. v. Sebelius,
`566 F.3d 193 (D.C. Cir. 2009) .................................................................................................. 37
`In re Barr Laboratories, Inc.,
`930 F.2d 72 (D.C. Cir. 1991) ........................................................................................ 23, 28, 29
`Immigr. & Naturalization Serv. v. Ventura,
`537 U.S. 12 (2002) .................................................................................................................... 19
`Intn'l Union, United Mine Workers of Am. v. Fed. Mine Safety & Health Admin.,
`920 F.2d 960 (D.C. Cir. 1993) ...................................................................................... 16, 17, 30
`Lutheran Church-Missouri Synod v. FCC,
`141 F.3d 344 (D.C. Cir. 1998) .................................................................................................. 16
`Motor Vehicle Mfrs. Ass’n v. State Farm Mutual Automobile Insurance Co.,
`463 U.S. 29 (1983) .................................................................................................................... 17
`Nat'l Parks Conservation Ass’n v. Semonite,
`422 F. Supp. 3d 92 (D.D.C. 2019) ............................................................................................ 37
`Nat’l Family Farm Coal. v. EPA,
`966 F.3d 893 (9th Cir. 2020) ....................................................................................................... 3
`Nat’l Wildlife Federation v. EPA,
`2005 WL 80958 (D.C. Cir. Jan. 13, 2005) ................................................................................ 20
`Penthouse Int’l, Ltd. v. Meese,
`939 F.2d 1011 (D.C. Cir. 1991) ................................................................................................ 11
`Policy and Research, LLC v. U.S. Dep’t of Health and Human Servs.,
`313 F. Supp. 3d 62 (D.D.C. 2018) ........................................................................................... 17
`Pub. Citizen Health Research Grp. v. Brock,
`823 F.2d 626 (D.C. Cir. 1987) .................................................................................................. 21
`Radio-Television News Directors Ass’n v. FCC,
`184 F.3d 872 (D.C. Cir. 1999) .................................................................................................. 37
`Reckitt Benckiser Inc. v. EPA,
`613 F.3d 1131 (D.C. Cir. 2010) .................................................................................................. 5
`San Luis & Delta-Mendota Water Auth. v. Jewell,
`747 F.3d 581 (9th Cir. 2014) ..................................................................................................... 26
`Sierra Club v. Van Antwerp,
`560 F. Supp. 2d 21 (D.D.C. 2008) ...................................................................................... 16, 20
`SKF USA Inc. v. United States,
`254 F.3d 1022 (Fed. Cir. 2001) ................................................................................................. 20
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`Sugar Cane Growers Co-op. of Fla. v. Veneman,
`289 F.3d 89 (D.C. Cir. 2002) .................................................................................................... 40
`U.S. Sugar Corp. v. EPA,
`830 F.3d 579 (D.C. Cir. 2016) .................................................................................................. 17
`Vanda Pharm., Inc. v. Food & Drug Admin.,
`2019 WL 1198703 (D.D.C. Mar. 14, 2019) .............................................................................. 17
`Wash. Toxics Coal. v. EPA,
`413 F.3d 1024 (9th Cir. 2005) ..................................................................................................... 7
`Wisconsin v. EPA,
`938 F.3d 303 (D.C. Cir. 2019) .................................................................................................. 39
`
`
`STATUTES 
`5 U.S.C. § 706(1) .......................................................................................................................... 28
`7 U.S.C. § 136(bb) .................................................................................................................... 3, 19
`7 U.S.C. § 136(p) .............................................................................................................................3
`7 U.S.C. § 136a-1(i)(1)(E)(ii) ........................................................................................................37
`7 U.S.C. § 136a(a)..................................................................................................................... 3, 11
`7 U.S.C. § 136a(c)(1) .......................................................................................................................3
`7 U.S.C. § 136a(c)(2)(B)................................................................................................................. 4
`7 U.S.C. § 136a(c)(3)(B)(ii) ...........................................................................................4, 13, 32, 33
`7 U.S.C. § 136a(c)(5) ................................................................................................................ 3, 13
`7 U.S.C. § 136a(c)(7)(A) .............................................................................................. 4, 13, 32, 33
`7 U.S.C. § 136a(c)(11) .................................................................................................................... 8
`7 U.S.C. § 136a(g) ................................................................................................................ 4, 5, 28
`7 U.S.C. § 136a(g)(1)(A)(v) ............................................................................................................5
`7 U.S.C. § 136a(g)(2) ...................................................................................................................... 4
`7 U.S.C. § 136d(a)(1) .....................................................................................................................11
`7 U.S.C. § 136d(b) ...........................................................................................................................5
`7 U.S.C. § 136d(d) .......................................................................................................................... 5
`7 U.S.C. § 136d(f) ......................................................................................................................... 10
`7 U.S.C. § 136d(f)(1)(B) ............................................................................................................... 10
`7 U.S.C. § 136d(f)(1)(C)(i) ........................................................................................................... 10
`7 U.S.C. § 136d(f)(1)(C)(ii) .......................................................................................................... 10
`7 U.S.C. § 136d(f)(1)(D)............................................................................................................... 10
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`7 U.S.C. § 136j(a)(2)(G) ..................................................................................................................3
`7 U.S.C. § 136n(a) .........................................................................................................................28
`7 U.S.C. § 136w-8(b)(3) tbl. 4 ...................................................................................................4, 13
`7 U.S.C. § 136w-8(b)(7)(F) .......................................................................................................... 37
`16 U.S.C. § 1531(b) ........................................................................................................................ 6
`16 U.S.C. § 1536 ............................................................................................................................. 6
`16 U.S.C. § 1536(a)(2) ........................................................................................................... passim
`16 U.S.C. § 1536(b)(3) ..............................................................................................................7, 27
`16 U.S.C. § 1536(c)(1) .................................................................................................................... 6
`16 U.S.C. § 1540(g) .......................................................................................................................28
`28 U.S.C. § 1331 ........................................................................................................................... 28
`28 U.S.C. § 2401(a) .......................................................................................................... 24, 33, 43
`
`RULES 
`Federal Rule of Civil Procedure 56 .............................................................................................. 17
`
`REGULATIONS 
`40 C.F.R. pt. 164 ............................................................................................................................. 5
`40 C.F.R. § 152.113 ................................................................................................................ 32, 33
`40 C.F.R. § 152.44 ........................................................................................................................ 35
`40 C.F.R. § 155.40 ...................................................................................................................... 4, 5
`40 C.F.R. § 155.42 ...........................................................................................................................4
`40 C.F.R. § 155.48 .......................................................................................................................... 4
`40 C.F.R. § 155.50 ...........................................................................................................................4
`40 C.F.R. § 155.53 .......................................................................................................................... 4
`40 C.F.R. § 155.56 ...........................................................................................................................5
`40 C.F.R. § 155.57 .......................................................................................................................... 4
`40 C.F.R. § 155.58(b)(2) ..................................................................................................................4
`40 C.F.R. § 155.58(b)(4) ..................................................................................................................4
`50 C.F.R. pt. 402 ............................................................................................................................. 6
`50 C.F.R. § 402.02 ........................................................................................................................ 18
`50 C.F.R. § 402.12 .......................................................................................................................... 6
`50 C.F.R. § 402.13 .................................................................................................................... 7, 19
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`50 C.F.R. § 402.13(a)...................................................................................................................... 7
`50 C.F.R. § 402.14 .................................................................................................... 6, 7, 18, 26, 27
`50 C.F.R. § 402.14(a).................................................................................................................. 6, 1
`50 C.F.R. § 402.14(b)(1) ..................................................................................................................7
`50 C.F.R. § 402.15 ........................................................................................................................ 27
`50 C.F.R. § 402.40(b) ................................................................................................................6, 26
`50 C.F.R. § 402.46 ...............................................................................................................6, 18, 26
`50 C.F.R. § 402.47 .....................................................................................................................6, 26
`
`OTHER AUTHORITIES
`Pub. L. No. 113-79 (2014) .............................................................................................................. 8
`Pub. L. No. 115-334 (2018) ............................................................................................................ 8
`Federal Practice and Procedure § 8384 (2d ed. 2021) ................................................................ 36
`Federal Pesticide Act of 1978: Hearings on S. 1678 before the Committee of Agriculture,
`Nutrition, and Forestry, 95 Cong. 69 (1979) ...................................................................... 13, 32
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`APA
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`BE
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`DOI
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`ESA
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`EPA
`FIFRA
`GIS
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`IDS
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`NRDC
`OPP
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`TABLE OF ACRONYMS
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`Administrative Procedure Act
`Biological Evaluation
`U.S. Department of the Interior
`Endangered Species Act
`Environmental Protection Agency
`Federal Insecticide, Fungicide, and Rodenticide Act
`Geographic Information Systems
`Incident Data System
`Natural Resources Defense Council
`Office of Pesticide Programs
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`
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`INTRODUCTION
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`The United States hereby responds to Plaintiff Natural Resources Defense Council, Inc.’s
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`motion for summary judgment, Dkt. No. 57, and cross-moves for voluntary remand without
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`vacatur and without imposing deadlines for completion of remand. Plaintiff’s motion challenges
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`thirteen pesticide product registrations. Id. However, registrants for four of these thirteen
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`products have requested voluntarily cancellation, which EPA intends to approve, thereby
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`rendering Plaintiff’s challenge to these four product registrations moot. See Declaration of
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`Marietta Echeverria (“Echeverria Decl.”) (Exhibit “Exh.” 1) ¶¶ 5-8.
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`EPA has acknowledged that it did not make Endangered Species Act (“ESA”) effects
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`determinations before registering the nine remaining products, and is seeking voluntary remand
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`to correct this error. See Declaration of Jan Matuszko (“Matuszko Decl.”) (Exh. 2) ¶¶ 29, 32-33.
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`EPA has satisfied the standard for voluntary remand.
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`Imposing deadlines for completion upon remand is unnecessary. EPA is taking its
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`responsibility to correct the failure to make effects determinations seriously and is already
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`engaging in steps to remedy this failure by undertaking a nationwide effects determination for
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`imidacloprid, the most widely used of the three active ingredients in product registrations
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`originally challenged in this case. EPA would like the opportunity to complete the same
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`comprehensive nationwide effects determinations for dinotefuran and acetamiprid, which would
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`include evaluating the impact of hundreds of products containing these neonicotinoids on nearly
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`1,800 listed species and their critical habitats for all authorized uses. However, should the Court
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`obligate EPA to complete its effects determinations of the nine remaining product registrations in
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`this case before it has completed the nationwide effects determination of active ingredients
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`dinotefuran and acetamiprid as part of the registration review process, then EPA would, out of
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`necessity, have to take a more piecemeal approach which would fail to properly capture the full
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`effect of the active ingredients on species and critical habitat and much of the analysis would not
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`be useful or directly transferrable to the subsequent nationwide registration reviews.
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`The Court should also decline to vacate the nine remaining product registrations upon
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`remand. The failure to conduct effects determinations prior to registering the nine products is
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`not a serious deficiency compelling vacatur as the labels of these “me too” or substantially
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`similar products incorporate the same language that was found necessary to mitigate ecological
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`risk for the original product registrations that contained the uses that were then determined to be
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`substantially similar to the ones in this case. Further, vacatur would result in disruptive
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`consequences. The three remaining dinotefuran products are the only three dinotefuran products
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`specifically registered for this type of liquid solution tree injection. Thus, vacatur would
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`eliminate an entire application method for combating devastating pests and cause significant
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`economic and environmental disruptions. And vacating the six acetamiprid “me too” product
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`registrations will not provide any benefit to any listed species because even if vacated pesticide
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`users would likely pivot to the many other similar acetamiprid products not challenged in this
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`case. Moreover, both acetamiprid and dinotefuran are effective at combating destructive and
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`invasive pests. Accordingly, equitable factors weigh against vacatur.
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`However, should this Court vacate the nine product registrations, it should decline
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`Plaintiff’s request for a deadline for EPA to make effects determinations because EPA would
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`no longer have an obligation under the ESA to conduct an effects determination for those
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`product registrations.
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`STATEMENT OF FACTS
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`Statutory and Regulatory Background
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`A. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
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`FIFRA generally precludes the distribution or sale of any pesticide unless it is
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`I.
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`“registered” by EPA. 7 U.S.C. § 136a(a). The registration process begins through submission of
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`a “statement,” which includes, among other things, the name and complete “formula of the
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`pesticide.” Id. § 136a(c)(1). EPA then provides “a notice of each application for registration of
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`any pesticide if it contains any new active ingredient or if it would entail a changed use pattern”
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`and allows opportunity for comments. Id. § 136a(c)(4).
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`EPA issues a license, referred to as a “registration,” for each specific pesticide product
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`allowed to be marketed. 7 U.S.C. § 136a(a). “The terms and conditions on the license include
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`exactly what product can be sold, the specific packaging it must be sold in, and labeling that
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`contains instructions on proper use.” Nat’l Fam. Farm Coal. v. EPA, 966 F.3d 893, 912 (9th Cir.
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`2020) (citing 7 U.S.C. § 136(p)). The Act directs that EPA “shall register a pesticide” if the
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`Agency determines that: (A) the pesticide’s composition warrants the proposed claims for it; (B)
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`its labeling complies with FIFRA; (C) it will perform its intended function without unreasonable
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`adverse effects on the environment; and (D) when used in accordance with widespread and
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`commonly recognized practice, it will not generally cause unreasonable adverse effects on the
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`environment. 7 U.S.C. § 136a(c)(5). “Unreasonable adverse effects on the environment”
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`include “any unreasonable risk to man or the environment, taking into account the economic,
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`social, and environmental costs and benefits of the use of any pesticide.” Id. § 136(bb). It is
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`unlawful to use a pesticide “in a manner inconsistent with its labeling.” Id. § 136j(a)(2)(G). A
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`pesticide product’s labeling is therefore integral to EPA’s registration decision and is the primary
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`means of accomplishing FIFRA’s mandate to prevent unreasonable adverse effects.
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`FIFRA provides for several different types of registrations, each with different legal
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`requirements. As relevant here, FIFRA Section 3(c)(7)(A) authorizes registration of pesticide
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`products that are identical or substantially similar in their uses and formulation to one or more
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`products already registered and marketed in the United States, or that differ only in ways that
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`would not significantly increase the risk of unreasonable adverse effects on the environment. 7
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`U.S.C. §§ 136a(c)(3)(B)(ii), 136w-8(b)(3) tbl. 4, & 136a(c)(7)(A). Such registrations are often
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`referred to as “me too” or “follow-on” registrations. These types of registrations are most often
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`granted when a company seeks to sell a pesticide product that is similar or identical in use and
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`formulation to a product already on the market or for combinations of previously approved
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`products.
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`EPA must periodically review pesticide registrations. 7 U.S.C. § 136a(g); 40 C.F.R. §
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`155.40 et seq.1 A registration review reflects EPA’s “determination whether a pesticide meets,
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`or does not meet, the standard for registration in FIFRA.” 40 C.F.R. § 155.57. EPA will create a
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`“registration review case” for one or more active ingredients in a pesticide and all of the products
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`containing such ingredients, establish a docket for public participation, and provide an
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`opportunity for comment. Id. §§ 155.42, 155.50. It may “call in” data necessary to conduct its
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`review. See 7 U.S.C. §§ 136a(c)(2)(B), (g)(2); 40 C.F.R. § 155.48. EPA will assess changes
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`since the pesticide’s last review and conduct new assessments as needed. 40 C.F.R. § 155.53.
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`In the course of a registration review, EPA may determine that certain label restrictions
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`are necessary for the pesticide to continue to meet the FIFRA standard of no unreasonable
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`1 EPA is currently reviewing registrations for roughly 1,140 pesticide active ingredients.
`See https://www.epa.gov/pesticide-reevaluation/registration-reviewprocess (last visiting June 11,
`2021).
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`adverse effects on human health or the environment. See id. § 155.58(b)(2), (4). EPA need not
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`tackle the entirety of the registration review at once, but rather may make an “interim registration
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`review decision.” Id. § 155.56. “Among other things, the interim registration review decision
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`may require new risk mitigation measures, impose interim risk mitigation measures, identify data
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`or information required to complete the review, and include schedules for submitting the
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`required data, conducting the new risk assessment and completing the registration review.” Id.
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`Unless EPA grants a FIFRA registration with a time limitation,2 it remains effective until
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`EPA cancels it, which is a statutorily defined administrative action subject to specific safeguards.
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`See 7 U.S.C. § 136d(b); 40 C.F.R. § 155.40; Reckitt Benckiser Inc. v. EPA, 613 F.3d 1131, 1134
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`(D.C. Cir. 2010). If EPA concludes that a pesticide product does not meet FIFRA’s standard,
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`and the registrant does not either agree to make sufficient changes to its registration or
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`voluntarily cancel the registration, EPA has discretion to initiate cancellation proceedings. See 7
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`U.S.C. § 136d(b). The cancellation process can be lengthy as it involves notifications to the
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`Secretary of Agriculture and the FIFRA Scientific Advisory Panel and then, if contested,
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`involves a hearing in front of an Administrative Law Judge. The final decision on cancellation
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`will occur only after completion of an administrative adjudicatory hearing. See id. § 136d(b),
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`(d); 40 C.F.R. pt. 164.
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`This statutory requirement—that cancellation of a FIFRA registration cannot be
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`automatic—extends to registration review. Congress provided that pesticide registrations shall
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`not be cancelled “as a result of the registration review process unless [EPA] follows the
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`procedures and substantive requirements” for cancellation set forth in Section 136d. Id. §
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`136a(g)(1)(A)(v).
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`2 The nine product registration at issue in this case are not time-limited.
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`5
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`Case 1:17-cv-02034-TSC Document 59-1 Filed 06/11/21 Page 15 of 55
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`B. The Endangered Species Act (ESA)
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`Congress enacted the ESA “to provide a means whereby the ecosystems upon which
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`endangered species and threatened species depend may be conserved