# Petition for Writ of Certiorari — CropLife America v. Baykeeper > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40386017_1208%3A1 ## Record - **Collection:** Supreme Court brief - **Document type:** Petition for Writ of Certiorari - **Published:** January 1, 2010 - **Citation:** 559 U.S. 936 ## Text No. 09- IN THE Supreme Court of the United States AMERICAN FARM BUREAU FEDERATION, AMERICAN FOREST & PAPER ASSOCIATION, AND NATIONAL COTTON COUNCIL, Petitioners, BAYKEEPER, et al., Respondents. On Petition for a Writ of Certiorari to the United States Court of Appeals for the Sixth Circuit PETITION FOR A WRIT OF CERTIORARI KLLEN STEEN Counsel of Record CLIFTON 8S. ELGARTEN JESSICA A. HALL CROWELL & MORING LLP 1001 Pennsylvania Ave., NW Washington, DC 20004-2595 (202) 624-2500 Counsel for Petitioners . ‘ EEE Or COUNSEL JULIE ANNA POTTS WILLIAM R. MURRAY AMERICAN FARM BUREAU AMERICAN FOREST & PAPER FEDERATION ASSOCIATION 600 Maryland Ave., SW 1111 - 19th Street, NW Suite 1000W Suite 800 Washington, DC 20024 Washington, DC 20036 WILLIAM A. GILLON GILLON & ASSOCIATES, PLLC 1163 Halle Park Circle Colherville, TN 38017 QUESTIONS PRESENTED 1. Did the Sixth Circuit err in holding that the “plain language” of the Clean Water Act precludes an EPA rule, consistent with 35 years of agency practice, that the application of a useful pesticide for its intended purpose and in accordance with relevant requirements of EPA’s pesticide regulatory program is not a “discharge of a pollutant”? 2. In reviewing an agency regulation under Chevron, may a_ court reject the agency's interpretation by declaring a “plain meaning” that departs from the common understanding of the controlling statutory provisions, without considering statutory context, the simultaneous enactment of a different statute more specifically addressing the subject matter, or the agency’s contemporaneous interpretation, all of which support the agency’s interpretation? (Q) PARTIES TO THE PROCEEDING Respondents are: Environmental petitioners before the Sixth Circuit: Baykeeper; Californians for Alternatives to Toxics; Calfornia Sportfishing Protection Alliance; Environment Maine; National Center for Conservation Science and Policy; Oregon Wild; Peconic Baykeeper, Inc.; Saint John’s Organic Farm; Soundkeeper, Inc.; Toxics Action Center; and Waterkeeper Alliance, Inc.; Environmental Protection Agency, respondent before the Sixth Circuit; and Industry petitioners before the Sixth Circuit: Agribusiness Association of lowa; Bayer CropScience, LP; BASF Corporation; CropLife America; Delta Council; Eldon C. Stutsman, Inc.; FMC Corporation; Illinois Fertilizer & Chemical Association; and Responsible Industry for a Sound Environment; Southern Crop Production Association; and Syngenta Crop Protection, Inc. RULE 29.6 STATEMENT American Farm Bureau has_ no _ parent corporation and no publicly held corporation owns 10% or more of its stock. American Forest & Paper Association has no parent corporation and no publicly held corporation owns 10% or more of its stock. National Cotton Council of America has no parent corporation and no publicly held corporation owns 10% or more of its stock. (11) TABLE OF CONTENTS Page ee Re 8 oS yy”) PARTIES TO THE PROCEEDING......... RR eT il RULE 29.6 STATEMENT.................00.... Saad veieteneen ll PRs RE GIG 0G EG vn vised so pcrevedcannsercessiyanencensesss lil PRE has COE BUF E WPAN LEED wines esccesvssssssanvecnsonavecesies Vv RF Ie MNO os cin cecnrcivcecornevesscsuece sessuscyrsveersssons 1 PE iis circches (odeisaks cies bucwsaanaaiinousireveatonedonns 1 STATUTORY PROVISIONS INVOLVED................. l STATEMENT OF THE CASE................. BR An Ber te ee l Fi. RREUCOTY BCR OPO aoe. oesccccccccsesencaccccnsseee, 2 B. Litigation Leading To The Rule ................. 6 C. The Rule And Its Rationale ........................ 8 BP. FR RIO BR Ga iaicsnssnrdsacncicscthussacisencs 10 EK. Epa’s Response To The Decision .............. 12 REASONS FOR GRANTING THE WRIT............... 13 I. THE BROAD REACH AND HARMFUL IMPACT OF THE SIXTH CIRCUIT’S DECISION MAKE THIS A CASE OF EXCEPTIONAL IMPORTANCE..............14 A. The Decision Overturns Three Decades of EPA Practice and Will Dramatically Expand the Scope of the NPDES Program...........15 (iu) IT. TABLE OF CONTENTS Continued B. The Decision Threatens Essential! Activities That Protect Our Nation’s Public Health and Food Supply.............. THE DECISION BELOW TRAMPLES SETTLED PRINCIPLES OF JUDICIAL REVIEW AND CONFLICTS WITH DECISIONS OF THIS COURT AND OTHER CIRCUITG.................... A. The Sixth Circuit’s Reading of “Chemical Wastes” and “From a Point Source” Overrides the Common Meaning of Those ry ae lane ee B. The Decision Contravenes This Court’s Precedents by Disregarding Statutory Context and History That Support the EPA Rule................. C. 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J W2a This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. This table lists the types of entities that EPA is now aware could potentially be affected by this action. Other types of entities not listed in the table could also be affected. To determine whether your facil- ity is affected by this action, you should carefully examine the applicability criteria in 40 CFR 122.23. If you have questions regarding the appli- cability of this action to a particular entity, consult the person listed in the’ preceding FOR FURTHER INFORMATION CONTACT section. Il. Background A. Clean Water Act and the Federal Insecticide, Fungicide, and Rodenticide Act Congress passed the Federal Water Pollu- tion Control Act (1972), also known as the Clean Water Act (CWA), to “restore and maintain the chemical, physical, and biological integrity of the nation’s waters” 33 U.S.C. 1251(a). The CWA pro- hibits the discharge of any pollutant by any per- son from a point source into a water of the United States, except in complhance with certain other provisions of the Act, including Section 402. 33 U.S.C. 1311(a). Section 402 in turn authorizes EPA to issue permits under the National Pollut- ant Discharge Elimination System (NPDES) per- mit program for such discharges. States may also issue NPDES permits if authorized to do so by EPA. 33 U.S.C. 1342(a) and (b). 73a NPDES permits under the CWA are required only for point source discharges of materials that are pollutants to waters of the United States. Sec- tion 502(6) of the CWA defines “pollutant” to mean: ** * dredged spoil, solid waste, incinerator residue, sewage, garbage, sewage sludge, muni- tions, chemical wastes, biological materials, ra- dioactive materials, heat, wrecked or discarded equipment, rock, sand, cellar dirt and industrial, municipal and agricultural waste discharged into water. 33 U.S.C. 1362(6).' In the more than 30 years that EPA has administered the CWA, the Agency has never issued an NPDES permit for the application of a pesticide to or over water to target a pest that is present in or over the water. Nor has the Agen- cy ever stated in any general policy or guidance that an NPDES permit is required for such appli- cations. ' The remaining language of the definition of “pollut- ant” in Section 502(6) is as follows, and is not relevant to to- day's action: “The term does not mean (A) “sewage from ves- sels’ within the meaning of Section 312 of this Act; or (B) wa- ter, gas, or other material which is injected into a well to facili- tate production of oil or gas, or water derived in association with oil or gas production and disposed of in a well, if the well used either to facilitate production or for disposal purposes is approved by authority of the State in which the well is located, and if such State determines that such injection or disposal will not result in the degradation of ground or surface water re- sources.” 74a EPA regulates the sale, distribution and use of pesticides in the United States under the statutory framework of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to ensure that when used in conformance with FIFRA label- ing directions, pesticides will not pose unreason- able risks to human health and the environment. All new pesticides must undergo a rigorous regis- tration procedure under FIFRA during which EPA assesses a variety of potential human health and environmental effects associated with use of the product. Under FIFRA, EPA is required to consider the effects of pesticides on the environment by de- termining, among other things, whether a pesti- cide “will perform its intended function without un- reasonable adverse effects on the environment,” and whether “when used in accordance with wide- spread and commonly recognized practice [the pesticide] will not generally cause unreasonable adverse effects on the environment.” 7 U.S.C. 136a(c)(5). In verforming this analysis, EPA exam- ines the ingredients of a pesticide, the intended type of application site and directions for use, and supporting scientific studies for human health and environmental effects and exposures. The appli- cant for registration of the pesticide must provide data from tests done according to EPA guidelines. This process is discussed in more detail below. Several courts have recently addressed the question of whether the CWA requires NPDES permits for pesticide applications. These cases have resulted in some confusion among the regu- lated community and other affected citizens about aan retin 75a the applicability of the CWA to pesticides applied to waters of the United States. In 2001, the U.S. Court of Appeals for the Ninth Circuit held in Headwaters, Inc. v. Talent Irrigation District (Talent) that an applicator of herbicides was re- quired to obtain an NPDES permit under the cir- cumstances before the court (described in detail in Section V.C. below). 243 F.3rd 526 (9th Cir. 2001). The Talent decision caused considerable concern and confusion among public health au- thorities, natural resource managers, and others who rely on pesticides regarding their potential obligation to obtain an NPDES permit when ap- plying a pesticide consistent with FIFRA and particularly about the impact of such a require- ment on accomplishing their mission of protect- ing human health and the environment. In 2002, the Ninth Circuit in League of Wilderness Defenders et al. v. Forsgren (Forsgren) held that the application of pesticides to control gypsy moths in National Forest lands required an NPDES permit. 309 F.3d 1181 (9th Cir. 2002). The court in Forsgren did not analyze the question of whether the pesticides applied were pollutants, because it assumed that the parties agreed that they were. In fact, the United States expressly re- served its arguments on that issue in its brief to the District Court. Id. at 1184, n.2. The court in- stead analyzed the question of whether the aerial application of the pesticide constituted a point source discharge, and concluded that it did. Id. at 1185. Since Talent and Forsgren, California, Ne- vada, Oregon, and Washington, all of which are 76a within the Ninth Circuit, have issued permits for the application of certain types of pesticides (e.g., products to control aquatic weeds and algae and products to control mosquito larvae). Other States have continued their longstanding prac- tice of not issuing permits to people who apply pesticides to waters of the United States. These va- rying practices reflect the substantial uncer- tainty among regulators, the regulated commu- nity, and the public regarding how the Clean Wa- ter Act applies to pesticides that have been prop- erly applied and used for their intended purpose. The Ninth Circuit recently addressed the Clean Water Act’s applicability to pesticide appli- cations for a third time. In Fairhurst v. Hagener, the court held that pesticides applied directly toa lake in order to eliminate non-native fish species, where there are no residues or unintended effects, are not “pollutants” under the CWA because they are not chemical wastes. 422 F.3d 1146 (9th Cir. 2005). Since Yalent and Forsgren, other courts have addressed the applicability of the CWA’s NPDES permit requirements to pesticide applica- tions. In Altman v. Town of Amherst (Altman), the Second Circuit vacated and remanded for further development of the record a District Court decision holding that the Town of Amherst was not required to obtain an NPDES permit to spray mosquitocides over waters of the United States. 47 Fed. Appx. 62, 67 (2nd Cir. 2002). The United States filed an amicus brief setting forth the Agency’s views in the context of that particular case. In its opinion, the Second Circuit stated 77a that “[ujntil the EPA articulates a clear interpre- tation of current law—among other things, whether properly used pesticides released into or over waters of the United States can trigger the requirement for NPDES permits * * *— the question of whether properly used pesticides can become pollutants that violate the CWA will re- main open.” Id. at 67. B. Interim and Interpretive Statements In August 2003, EPA first analyzed the ap- plicability of the NPDES permit program to pesti- cide applications in an administrative context through an Interim Statement and Guidance. 68 FR 48385 (Aug. 13, 2003). The Interim Statement pre- sented EPA’s position on the two circumstances in which pesticides applied to waters of the United States consistent with all relevant requirements of FIFRA are not “pollutants” under the CWA and thus do not require an NPDES permit. Although the United States previously addressed issues re- lated to the Interim Statement in several amicus briefs, including those filed in Talent and Altman, those briefs reflected the government’s evaluation of the law in the context of specific factual situa- tions, and did not result from deliberative consid- eration through an administrative process. As such, the amicus briefs did not represent EPA’s legal position on the precise questions at issue in the Interim Statement or in today’s regulation. EPA solicited public comments on its inter- pretation of the term “pollutant” in the Interim Statement as it relates to certain pesticide appli- cations. After considering the public comments, 78a EPA issued a final Interpretive Statement on Jan- uary 25, 2005. EPA simultaneously published a notice of proposed rulemaking to incorporate the substance of the Interpretive Statement into EPA regulations and solicited public comment on the proposed rulemaking. 70 FR 5093 (Feb. 1, 2005). EPA has considered the comments received and is today taking final action on the proposed regula- tion. The final regulation is substantially similar to the proposed regulations, with certain modifica- tions described below.? Ill. Summary of the Final Rule EPA is revising the NPDES permit program regulations to add a paragraph to the list of dis- charges in 40 CFR 122.3 that are excluded from NPDES permit requirements. Specifically, today’s regulation excludes applications of pesticides to waters of the United States consistent with all re- levant requirements under FIFRA in two specific circumstances as follows: (1) The application of pesticides directly to waters of the United States in order to control pests. Examples of such applications include ap- plications to control mosquito larvae, aquatic 2 On March 29, 2002, EPA issued an Interpretive Statement and Regional Guidance on the Clean Water Act’s Exemption for Return Flows from Irrigated Agriculture, which clarified that the application of an aquatic herbicide consistent with the FIFRA labeling to ensure the passage of irrigation re- turn flow is a nonpoint source activity not subject to NPDES permit requirements under the Clean Water Act. This regula- tion does not address the March 2002 guidance. 79a weeds, or other pests that are present in waters of the United States. (2) The application of pesticides to control pests that are present over waters of the United States, including near such waters, where a por- tion of the pesticides will unavoidably be depos- ited to waters of the United States in order to target the pests effectively; for example, when insecticides are aerially applied to a forest canopy where waters of the United States may be present below the canopy or when pesticides are applied over or near water for control of adult mosquitoes or other pests. Pesticides applied under these circumstances are not pollutants and therefore are not subject to NPDES permitting requirements. EPA’s final rule is substantially similar to the rule proposed in February 2005. EPA has mod- ified the proposed regulatory text only to clarify the types of pesticide applications covered in the second circumstance (those to control pests pre- sent over, including near, waters of the United States). Commenters raised concerns that the sec- ond circumstance, as written in the proposed rule, could be interpreted more broadly than the Agency intended (e.g. encompassing drift from ter- restrial pesticide applications). The final rule cla- rifies that the applications in the second circum- stance are those in which it is unavoidable that some of the pesticides will be deposited into wa- ter in order to effectively target the pests. In other words, EPA is clarifying in the final rule that the regulation encompasses only those applica- 80a tions to control pests over, including near, wa- ters of the United States, where the pesticide necessarily must enter the water in order for the application to achieve its intended purpose. Thus, the applications must first be intended to control pests over (including near) a water of the United States. Second, it must be unavoidable that the pesticide enter the water in order to target such pests effectively. For example, EPA believes that wide-area forest canopy insecticide applications can result in deposition to streams and other wa- ters of the U.S. which are either not visible to the aerial applicator or not possible to avoid given the location of aerial application, and that in such cir- cumstances, it is unavoidable that the pesticide en- ter the water in order to effectively target pests living in the canopy. Likewise, mosquito adulticide applications can result in some pesticide product entering the water because adult mosquitoes gen- erally live over and adjacent to waterbodies. Simi- larly, pesticide applications to control non-native plants which grow at the water’s edge, such as purple loosestrife, are intended to be covered by this provision, because when targeting plants at the water’s edge, it is unavoidable that some of the herbicide will enter the water. EPA notes that the clarifying language in § 122.3(h)(2) is not intended to impose any additional requirements on pesticide applications beyond relevant FIFRA requirements. In addition, it is not intended to address applica- tions of pesticides to terrestrial agricultural crops. IV. Discussion Today's rulemaking implements EPA’s in- terpretation of the CWA’s definition of “pollutant” Sla with respect to certain applications of pesticides. Under the CWA, pollutant means: * * * dredged spoil, solid waste, incinerator resi- due, sewage, garbage, sewage sludge, munitions, chemical wastes, biological materials, radioactive materials, heat, wrecked or discarded equipment, rock, sand, cellar dirt and industrial, municipal, and agricultural waste discharged into water. 33 U.S.C. 1362(6). The circumstances of pesticide applications covered under today’s rule are limited to the two types of applications described above, when con- ducted in compliance with all relevant require- ments of FIFRA. EPA considers “relevant re- quirements” of FIFRA to mean those FIFRA re- quirements that relate to water quality. For in- stance, violating a requirement that the person mixing the pesticide must wear protective clothing, while an unlawful act that can be enforced under FIFRA, is not related to the protection of water quality, and therefore not a relevant FIFRA re- quirement for purposes of today’s regulation. However, a labeling provision that governs appli- cation rates, active ingredient concentrations and dilution requirements, buffer zones, application locations, intended targets, times of day, tempera- ture or other application requirements, and thus concerns the amounts, concentrations, and viabil- ity of substances that may potentially end up in waters of the United States, is related to water quality. Relevant FIFRA requirements may appear in product labeling, FIFRA regulation, or other documents setting forth requirements applied pur- suant to FIFRA. 82a The application of a pesticide from a point source to waters of the United States requires an NPDES permit only if it constitutes the dis- charge of a “pollutant” within the meaning of that term in the CWA. EPA has evaluated whether pesticides regulated under and applied consistent with relevant FIFRA requirements for the two cir- cumstances previously described fall within the terms in the CWA’s definition of “pollutant,” and concludes that they do not. Pesticides are not dredged spoil, solid waste, incinerator residue, se- wage, garbage, sewage sludge, munitions, radioac- tive materials, heat, wrecked or discarded equip- ment, rock, sand, cellar dirt or industrial, mu- nicipal, and agricultural waste. See CWA section 502(6). In addition, as described below, the terms, “chemical waste” and “biological materials,” also do not encompass the types of pesticide applica- tions addressed in today’s action. First, such pesticides are not “chemical wastes.” The term “waste” ordinarily means that which is “eliminated or discarded as no longer useful or required after the completion of a proc- ess.” The New Oxford American Dictionary 1905 (Elizabeth J. Jewell & Frank Abate eds., 2001). Pesticides applied consistent with relevant FIFRA requirements are not “wastes” as that term is commonly defined—on the contrary, they are products that EPA has evaluated and registered for the purpose of controlling target organisms, and are designed, purchased, and applied to perform that purpose. See Fairhurst v. Hagener, 422 F.3d at 1150. 83a EPA also interprets the term “biological materials” not to include biological pesticides ap- plied consistent with relevant FIFRA requirements. This interpretation is both reasonable and consis- tent with Congressional intent, and is supported by relevant case law. It is unlikely that Congress intended to include biological pesticides applied in the circumstances described in today’s rule within the Clean Water Act’s definition of “pollutant.” To do so would mean that biological pesticides are pollutants, while chemical pesticides used in the same circumstances are not. Since biologically and chemically based pesticides applied consis- tent with relevant requirements adopted by EPA under FIFRA are both EPA-evaluated products, treating them differently under the Clean Water Act is not warranted. Moreover, at the time the Act was adopted in 1972, chemical pesticides were predominant. It is therefore not surprising that Congress failed to discuss whether biological pes- ticides were to be covered by the Act. The fact that more biological pesticides have been devel- oped since passage of the Act in 1972 does not justify expanding the reach of the NPDES per- mit requirement when there is no evidence that Congress intended the CWA to regulate biologi- cal pesticides in a manner different from chemical pesticides. Finally, biological pesticides in use to- day are generally reduced-risk products that have a narrower range of potential adverse envi- ronmental effects compared to many chemical pesticides. For this reason it would not make sense, and would be inconsistent with the goals of the Clean Water Act, to discourage the use of bio- logical pesticides by requiring applicators of these S4a products to obtain an NPDES permit when chem- ical pesticides have no such requirement. In cases in which courts have found specific biological materials to be “pollutants” under sec- tion 502(6) the substances at issue were waste ma- terials discharged from a point source. See Con cerned Area Residents for the Environment v. South view Farm, 34 F.3d 114 (2d Cir. 1994) (liquid manure is solid waste, sewage, biological material, and agricultural waste and is therefore a pollutant); USPIRG vy. Atlantic Salmon, 215 F.Supp. 2d 239, 247-49 (D. Maine 2002) (non- native fish escaped from net pens and salmon feces and urine exiting net pens are biological materials; pharmaceuticals in excess salmon feed exiting net pens are chemical wastes), National Wildlife Federation v. Consumers Power Co., 862 F.2d 580, 585 (6th Cir. 1988) (live fish, dead fish, and fish remains released from hydro-electric facility's tur- bine are biological materials), U.S. v. Plaza Health Laboratories, Inc., 3 F.3d 6438, 646 (2d Cir, 1993), cert. denied 114 S.Ct. 2764 (1994) (discarded vials of human blood are pollutants). In none of these cases, which were cited by commenters, did a court find that a product applied for its in- tended purpose consistent with applicable EPA re- quirements was a “biological material” and there- fore a pollutant under the CWA. The Ninth Circuit Court of Appeals in Assn. to Protect Hammersley, Eld, and ‘Totten Inlets (APHETI) v. Taylor Resources, Inc., 299 F.3d 1007, 1017 (9th Cir. 2002), cited to several of these cases as being 1n accord with its finding that “bio- logical materials” means the waste product of a S5a human or industrial process. The APHETI court based its decision that mussel shells, mussel fe- ces, and other matcrials emitted from mussels grown on harvesting rafts are not pollutants on the doctrine of ejusdem generis. The court found that the more specific terms in the CWA’s defini- tion of “pollutant” support an understanding of the more general term “biological materials” as waste material of a human or industrial process. Id. at 1015. The court went on to analyze Con- gress’ intent in enacting the CWA and found that the purpose of the statute further sup- ported such an interpretation of biological mate- rials in that case. /d. at 1016. Furthermore, EPA’s interpretation that biological and chemical pesticides are not pollut- ants is reasonable because both types of pesti- cides must comply with FIFRA registration re- quirements. EPA reviews and evaluates these pesticides and authorizes their use, subject to the limitations and requirements of the EPA registra- tion. Today's action applies only to the specific categories of pesticide applications addressed in the text of the regulation. EPA notes that pesticides are waste materials, and therefore pollutants under the Act, when contained in a_ waste stream, including storm water regulated under section 402(p) or other industrial or municipal! discharges. In those circumstances, an NPDES permit may be required if the pesticides are dis- charged into a water of the United States from a point source. S6a In addition, if there are residual materials resulting from pesticides that remain in the water after the application and its intended purpose (elli- mination of targeted pests) have been completed, these residual materials are also pollutants un- der CWA section 502(6) because they are wastes of the pesticide application. Such residuals include excess amounts of pesticide that do not reach a target organism and materials that remain after the application has completed its intended task. These materials are waste materials, as that term is commonly defined, because they are sub- stances that are “no longer useful or required after the completion of a process.” The New Oxford American Dictionary 1905, supra. See also Fair. hurst v. Hagener, 422 F.3d 1146. However, pesticide applications under the circumstances described above and consistent with FIFRA do not require NPDES permits, even if the application leaves residual materials which are “pollutants” under the Act in waters of the United States. Section 301(a) of the CWA prohib- its the “discharge of any pollutant” except in compliance with certain other provisions of the Act. The CWA defines “discharge of a pollutant” to mean “any addition of any pollutant to navigable waters from any point source.” Thus, at the time of discharge to a water of the United States, the ma- terial in the discharge must be both a pollutant, and from a point source. In this case, while the discharge of the pesticide is from a point source (generally a hose or an airplane), it is not a pol- lutant at the time of the discharge. The material added by a pesticide applicator to or over, in- cluding near, water is not a pollutant for the rea- 87a sons stated above. Even though the pesticide may become a “pollutant” at a later time (e.g., after the pesticide product has served its intended pur- pose), a permit is not required for its application because it did not meet both statutory prerequi- sites (pollutant and point source) at the time of its discharge into the water. Instead, the residual should be treated as a nonpoint source pollutant, potentially subject to CWA programs other than the NPDES permit program (e.g., listing and TMDL development pursuant to CWA section 303(d)). Today’s action does not address drift over and into waters of the United States from pesti- cide applications to land. As discussed below, EPA has established a multi-stakeholder work- group under one of its federal advisory committees to explore policy issues relating to the terrestrial application of pesticides that may drift into aquatic environments. EPA also notes that to- day's discussion of the terms “chemical waste” and “biological materials” applies only for CWA pur- poses and is not intended to address the use of those terms or similar terms under any other stat- utes the Agency administers. V. Public Comment EPA first solicited corament on its interpreta- tion of “pollutant” under the CWA with respect to certain pesticide applications on August 13, 2003. See 68 FR 48385 (Aug. 13, 2003). EPA provided a second opportunity for public comment on its in- terpretation when it proposed the regulation on which the Agency is today taking final action. See 70 FR 5093 (Feb. 1, 2005). EPA received many 88a comments on its interpretation during both com- ment periods, from a wide range of interested parties including pesticide manufacturers and applicators, public health control agencies, State agricultural agencies, State environmental agen- cles, environmental groups, human health advo- cates, farming interests, and other members of the public. Many commenters supported EPA’s interpretation, while others opposed it as incon- sistent with the CWA. The record for today’s action contains EPA’s detailed responses to comments received during both public comment periods. See Docket ID No. OW-2003— 0063 at hAttp://www.regulations.gov. EPA is providing a summary below of its re- sponses to some of the significant comments re- ceived. A. Scope of Regulation Many of the commenters who supported KPA’s proposed rule also recommended that EPA broaden the scope of the final rule to cover all pesticide applications, including agricultural ap- plications over land, that are conducted in accor- dance with the relevant requirements of FIFRA. This final rule addresses only the following two circumstances described in the proposed rule: The application of aquatic pesticides directly to wa- ters of the United States, and the application of pesticides to control pests over, including near, such waters. In the meantime, EPA will continue to follow its long-standing practice of not requiring NPDES 89a permits for agricultural pesticide applications that are conducted in compliance with relevant FIFRA requirements. EPA is continuing to con- sider the applicability of the CWA to situations other than those EPA is addressing in today’s action where pesticides applied in accordance with relevant FIFRA requirements may reach and enter waters of the United States, including drift of pesticides applied aerially over land. Therefore, EPA does not believe it is appropriate to broaden the scope of the regulation to include additional types of pesticide applications at this time. To assist the Agency’s consideration of these issues, EPA has established a workgroup under the existing Pesticide Program Dialogue Committee (PPDC) (an advisory committee char- tered under the Federal Advisory Committee Act (FACA)) to address issues involving pesticide spray drift from agricultural and other applica- tions. The goals of the workgroup are the follow- ing: (1) Improving understanding of the perspec- tives of all stakeholders regarding pesticide spray drift; (2) finding common ground for fur- ther work toward minimizing both the occurrence and potential adverse effects of pesticide spray drift; (3) developing options for undertaking work where common ground exists; and (4) exploring the extent of drift, even with proper usage, and the range and effectiveness of potential responses to unacceptable levels of off-target drift. The spray drift workgroup will provide advice to EPA through the PPDC. 90a The PPDC is a FACA-authorized forum for a diverse group of stakeholders to provide feed- back to the Agency’s pesticide program on various pesticide regulatory, policy, and program im- plementation issues. Topics of discussion at past meetings have included the disclosure of inert ingredients, registration review, nonanimal test- ing, antimicrobial pesticides, endangered species, reduced risk pesticides, labeling, minor uses, eco- logical standards, fees for service, experimental use permits, environmental marketing claims, outreach to the public, and several implementation issues emanating from the Food Quality Protec- tion Act of 1996. Members of the PPDC include representatives of environmental and public interest groups, pesti- cide manufacturers and trade associations, user and commodity groups, public health and aca- demic institutions, federal and State agencies, and the general public. Participants in the Spray Drift workgroup reflect the range of stakeholder interests represented on the full PPDC, and also include members with backgrounds in water quality issues. By operating under the PPDC, the Spray Drift workgroup will comply with FACA pro- cedural requirements including timely public no- tice of meetings, public access to meetings and op- portunity for the public to comment; public avail- ability of documents considered by the workgroup; and attendance of a federal officer or employee at each meeting. Yla B. Sufficiency of FIFRA to Address Water Quality Impacts of Pesticide Applications Many commenters objected to the proposed rule on the basis that EPA’s regulation of pesti- cides under FIFRA does not adequately protect water quality, and thus pesticide applications should require an NPDES permit. These comment- ers alleged both legal and policy shortcomings of FIFRA. They also asserted that EPA’s interpreta- tion is improper because FIFRA does not preempt CWA requirements and because EPA lacks au- thority to exempt categories of discharges from the CWA’s prohibition against discharges without an NPDES permit. These commenters may have misinterpreted the legal interpretation that provides the basis for today’s action. First, EPA is not expressly or by implication repealing any provision of the CWA in today’s action, nor is the Agency arguing that FIFRA registration preempts CWA section 301(a) or section 402(a). Moreover, EPA is not arguing that registration under FIFRA or compliance with FIFRA requirements replaces or satisfies an oth- erwise applicable requirement under the CWA to obtain an NPDES permit. Nor is EPA exempting from section 301(a) or section 402(a) any categories of pollutants, because the pesticide applications at issue here are not pollutants under the Act. The proscription in the CWA against discharging pol- lutants from point sources to waters of the United States except in compliance with section 402 con- tinues to apply. Rather, EPA is exercising its au- thority to interpret a term in a statute it adminis- ters. EPA is clarifying that pesticides applied to or 92a over, including near, water for their intended purpose consistent with all relevant requirements under FIFRA in the circumstances specified in the rule are not, at the time of application, “pollut- ants” under the CWA, and therefore applications are not discharges required to obtain permits. EPA’s review, evaluation, and registration of pesticides used in these two circumstances fur- ther demonstrate that this is a reasonable inter- pretation, consistent with Congressional intent. EPA’s regulatory programs under FIFRA provide support for the Agency’s conclusion that the pesti- cides applied to or over, including near, water are not wastes (and therefore not pollutants) and serve as an indicator of when a pesticide 1s being applied as a product for its intended, beneficial purpose. Under FIFRA, EPA receives applications from people who wish to sell and distribute pesti- cides. The Agency may approve and issue a regis- tration for a product if EPA determines that the product will not cause “unreasonable adverse ef- fects on the environment,” which is defined as “any unreasonable risk to man or the environ- ment, taking into account the economic, social and environmental costs and benefits of the use of [a] pesticide * * *.” FIFRA Section 3(c)(5). In other words, the Agency may register a pesticide only if the product provides economic, social, and envi- ronmental benefits that outweigh risks from its use. As part of FIFRA registration, EPA may es- tablish requirements, which are typically con- tained in the label for the pesticide, to ensure that when used, it will not cause unreasonable adverse effects on the environment, including the aquatic environment. Thus, registration and use 93a of a pesticide in accordance with its approved la- beling or other relevant FIFRA requirements in- dicates that a pesticide is a product intended to be used for a beneficial purpose that is authorized by EPA and is not a waste. For these reasons, comments regarding the adequacy of EPA’s pes- ticide regulatory program do not pertain to the le- gal interpretation of whether a pesticide is a “chemical waste” or a “biological material” for pur- poses of the definition of “pollutant” under the CWA. Nonetheless, it is important to note that EPA disagrees with commenters’ concerns that EPA’s registration process does not take into ac- count local conditions, existing water quality standards and use designations, synergistic ef- fects of multiple pesticides, inert ingredients, non- target aquatic organisms, and the effect of multi- ple applicators in the same area. The regulatory and non-regulatory tools under FIFRA provide means of addressing water quality problems aris- ing from the use of pesticides. In particular, the pesticide registration and re-registration proc- esses consider impacts on both human health from the presence of pesticides in drinking water, and on aquatic resources (e.g., fish, invertebrates, plants, and other species in fresh water, estuarine, and marine environments). EPA requires a pesti- cide company to submit a substantial body of data in support of an application for registration. EPA then supplements this required database with in- formation obtained through a systematic search of the open literature on the ecotoxicity of environ- mental substances. EPA compares the estimated environmental concentrations expected to result 94a from use of a pesticide with toxicity values ob- served in required studies and studies from the open literature. This database provides sufficient information to conduct assessments of potential ecological and human health risks, including the identification of toxicologically significant degra- dation products and/or metabolites. For addi- tional information on EPA’s approach to ecologi- cal risk assessment in general, and endangered and threatened species in_ particular, see: http: //www.epa.gou/espp/consultation/ecorisk- overview.pdf. C. EPA's Interpretation of the Term “Pollutant” Un- der the CWA Some commenters claimed that EPA’s inter- pretation of the term “pollutant” is inconsistent with the Clean Water Act, with relevant case law, or with prior Agency statements. EPA disagrees with the commenters and believes its interpreta- tion of the term “pollutant” is reasonable and con- sistent with the language and legislative intent of the Clean Water Act. As described above, pesti- cides applied in the circumstances addressed in to- day’s regulation, in compliance with FIFRA, for their intended purpose, are not pollutants under the Act. EPA also disagrees with commenters that the term “biological materials” can only be read to include biological pesticides applied in the circum- stances addressed by today’s regulation—i.e., appli- cation to or over waters of the United States con- sistent with relevant requirements of FIFRA. EPA’s analysis of the terms “chemical waste” and “biological materials” in the circumstances ad- 95a dressed by today’s regulation is described in more detail above. In addition, the Ninth Circuit Court of Ap- peals recently held that pesticides that do not generate a residue when applied directly to a lake to eliminate a non-native fish species are not “pollutants” under the CWA because they are not chemical wastes. Fairhurst v. Hagener, 422 F.3d 1146 (9th Cir. 2005). In so holding, the court considered the plain meaning of the term “chem- ical waste” and noted that its analysis was in ac- cord with EPA’s interpretation of the term in its July 2003 Interim Statement, and that EPA’s in- terprcetation is “reasonable and not in conflict with the expressed intent of Congress.” Jd. at 1149-50. Today’s regulation is based on the same interpre- tation EPA first articulated in the Interim Statement, and is consistent with the Fairhurst court’s holding. Moreover, EPA’s interpretation is not incon- sistent with Jalent and Forsgren as some com- menters have asserted. As explained below, these cases do not interpret the term “pollutant” as in- cluding the pesticide applications addressed in to- day’s rule. In Headwaters v. Talent, the Ninth Circuit reversed the District Court’s dismissal of a CWA citizen suit against an irrigation district alleging that application of the herbicide Magnacide H to irrigation canals to control aquatic weeds and ve- getation required an NPDES permit. The District Court had concluded that the application of the pesticide was adequately regulated under 96a FIFRA, and further regulation under the CWA was unnecessary. Headwaters v. Talent, No. 98— 6004-AA slip op. at 12 (D. Ore. Feb. 1, 1999). The Ninth Circuit found that residual from the appli- cation of Magnacide H was a pollutant in this case and that registration of the herbicide un- der FIFRA did not preclude applicability of the CWA. Headwaters v. Talent, 243 F.3d at 532. This conclusion is consistent with EPA’s interpre- tation. As described above, EPA agrees that re- sidual materials from pesticide applications are “pollutants” under the Act. In addition, the irriga- tion district in Talent failed to comply with a FIFRA registration requirement to contain the herbicide-laden water in an irrigation canal for a specified number of days. EPA’s interpretation co- dified in today’s action is that pesticides applied in the circumstances described in the rule are not “pollutants” where they are applied consistent with relevant FIFRA requirements. Thus, EPA’s interpretation is consistent with the result reached by the Talent court. In League of Wilderness Defenders v. Fors- vren, the Ninth Circuit held that the aerial applica- tion of insecticides over National Forest lands in Washington and Oregon to control a predicted outbreak of the Douglas fir tussock moth required an NPDES permit. However, the court in Fors- gren stated incorrectly that the parties in the case did not dispute that the insecticides met the CWA definition of “pollutant.” League of Wilder- ness Defenders v. Forsgren, 309 F.3d at 1184, n.2. In fact, the Forest Service in its brief before the District Court reserved its arguments on that par- ticular issue. Because the Ninth Circuit errone- 97a ously assumed that the question of whether the applications were pollutants was not in dispute, it did not analyze the issue but simply stated that they were. Jd. at 1185. The issue that the Forsgren court did analyze in detail was whether the airplanes from which the insecticides were sprayed are point sources under the CWA—a dif- ferent issue from that addressed in today’s inter- pretation.* Commenters also claimed that EPA’s inter- pretation is inconsistent with the Clean Water Act because the purpose for which a pesticide is ap- plied is not relevant to the question of whether it is a pollutant under the Act. The commenters pointed primarily to two cases—Hudson River Fish- erman’s Assn. v. City of New York, 751 F.Supp. 1088 (S.D.N.Y.), aff'd., 940 F.2d 649 (2d Cir. 1991), and Minnehaha Creek Watershed District v. Hoffman, 597 F.2d 617 (8th Cir. 1979)—as supporting their assertion. However, both these cases are dis- tinguishable from EPA’s interpretation. 3 EPA’s General Counsel issued a memorandum on September 3, 2003, addressing the Agency’s views on the effect of the Forsgren decision. Specifically, EPA stated that it did not acquiesce outside the Ninth Circuit with the court’s decision regarding the application of EPA regulation defin- ing “silvicultural point source” at 40 CFR 122.27(b)(1), and would continue to follow its longstanding interpretation of the statute and these regulations. Memorandum from Robert E. Fabricant to Regional Administrators, “interpretive State- ment and Guidance Addressing Effect of Ninth Circuit Deci- sion in League of Wilderness Defenders v. Forsgren on Appli- cation of Pesticides and Fire Retardants,” Sept. 3, 2003. 98a In Minnehaha Creek, the court was inter- preting the terms “rock, sand, [and] cellar dirt” in the definition of “pollutant” in CWA Section 502(6). The federal appellants in that case ap- pealed a District Court decision finding that the U.S. Army Corps of Engineers did not have juris- diction under CWA Section 404 over the place- ment of riprap and the construction of dams in Minnehaha Creek and adjacent Lake Minne- tonka. The District Court’s decision was based on its conclusion that the creek and the lake were not navigable waters of the United States and that while the riprap and construction materials were “rock and sand,” the activities at issue in the case were not within the purview of the Act because they did not significantly affect water quality. Minnehaha Creek Watershed District v. Hoffman, 449 F.Supp 876, 886 (D. Minnesota 1978). The Eighth Circuit disagreed and held that a signifi- cant alteration in water quality need not be dem- onstrated for a substance to be a pollutant. Minne- haha Creek Watershed District v. Hoffman, 597 F.3d at 626-27. The Eighth Circuit stated in Minnehaha Creek that it found “no justification in the District Court’s determination that whether the discharge of a particular substance listed in sfection] 502(6) constitutes the discharge of a ‘pollutant’ under the Act depends upon the purpose for which the dis- charge is made.” /d. at 627, emphasis added. EPA notes that nowhere in its opinion does the District Court reach such a conclusion. In any case, EPA is not concluding that the question of whether a sub- stance is a pollutant depends on the specific purpose for which it is discharged. Rather, EPA 99a is interpreting what specific terms in section 502(6) mean in the context of certain pesticide ap- plications. The Second Circuit Court of Appeals deci- sion in Hudson River Fishermen’s Assn. v. City of New York is also distinguishable from the circum- stances addressed in today’s rule. In that case, the District Court held that discharges of chlorine and aluminum sulfate (alum floc) from an aque- duct into a reservoir were discharges of pollut- ants requiring an NPDES permit. First, this case involved the discharge of alum floc from a point source at a point when it was a “chemical waste” and, therefore, consistent with EPA’s interpreta- tion, properly constituted a pollutant under the statute. Hudson River Fishermen’s Assn. v. City of New York, 751 F.Supp 1088, 1102. In contrast, to- day’s rule addresses certain pesticides which are being applied in compliance with relevant FIFRA requirements and, for the reasons de- scribed above, are not pollutants. Moreover, the court’s holding that chlorine was a pollutant also referred to the chlorine in the aqueduct at the time it discharged into the res- ervoir, not at the time it was first added to the water. The court held that the chlorine was a pol- lutant, no matter how useful it may earlier have been, citing to the Eighth Circuit’s decision in Minnehaha Creek. Id. at 1101. Similarly, EPA is not concluding that the question of whether sub- stances listed in section 502(6) are pollutants de- pends on the purpose for which they are dis- charged. Rather, EPA is interpreting what spe- cific terms in section 502(6) (terms other than 100a those addressed in Minnehaha Creek) mean in the context of these two types of pesticide applica- tions. Finally, while EPA’s interpretation is not in- consistent with either Hudson River or Minnehaha Creek, it is further supported by the Ninth Cir- cuit’s decision in Fairhurst v. Hagener. In Fair- hurst, the Ninth Circuit specifically considered the purpose for which the pesticide was applied—the same factor commenters claim is not relevant un- der Hudson River and Minnehaha Creek— and the fact that it was applied consistent with the product’s FIFRA label, in concluding that it was not a pollutant under the CWA. Fairhurst v. Ha- gener, 422 F.3d 1146, 1150 (“Because intentionally applied and properly performing pesticides are not ‘pollutants,’ a potential discharger is not re- quired to secure an NPDES permit for such pesti- cides before discharge.”) Some commenters also claimed that EPA's interpretation is inconsistent with positions taken by the government in several amicus curiae briefs related to the issues addressed by the in- terpretation. As mentioned above, these briefs reflected the government's evaluation of the law in the context of the specific factual situations at issue and did not result from the deliberative con- sideration through an administrative process, as today’s rule does. As such, the briefs were not a comprehensive statement of EPA’s legal position on the precise questions addressed in today’s rule, nor did they reflect the exercise of EPA’s legal and policy judgment after consideration of public com- ments. See Memorandum from Ann R. Klee to Ben- lOla jamin Grumbles and Susan Hazen, “Analysis of Previous Federal Government Statements on Ap- plication of Pesticides to Waters of the United States in Compliance with FIFRA,” Jan. 24, 2005. VI. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is a “significant regu- latory action.” Accordingly, EPA submitted this action to the Office of Management and Budget (OMB) for review under Executive Order 12866 and any changes made in response to OMB rec- ommendations have been documented in the docket for this action. B. Paperwork Reduction Act This action does not impose an information collection burden under the provisions of the Pa- perwork Reduction Act, 44 U.S.C. 3501 et seq. This rule merely identifies two circumstances in which the application of a pesticide to waters of the United States consistent with all relevant re- quirements under FIFRA does not constitute the discharge of a pollutant that requires an NPDES permit under the Clean Water Act. Burden means the total time, effort, or fi- nancial resources expended by persons to gener- ate, maintain, retain, or disclose or provide infor- mation to or for a Federal agency. This includes the time needed to review instructions; develop, 102a acquire, install, and utilize technology and sys- tems for the purposes of collecting, validating, and verifying information, processing and main- taining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and re- quirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of in- formation; and transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person Is not required to respond to a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA’s regulations in 40 CFR are listed in 40 CFR part 9. C. Regulatory Flexibility Act The Regulatory Flexibility Act (RFA) gener- ally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Ad- ministrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substan- tial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions. For purposes of assessing the impacts of to- day’s rule on small entities, small entity is defined as: (1) A small business based on Small Business Administration (SBA) size standards at 13 CFR 103a 121.201; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a popula- tion of less than 50,000; and (3) a small organiza- tion that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field. After considering the economic impacts of today’s rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. Because EPA is identifying two circumstances in which the application of a pesticide to waters of the United States consistent with all relevant requirements under FIFRA does not constitute the discharge of a pollutant that requires a NPDES permit under the Clean Water Act, this action will not impose any requirement on any small entity. D. Unfunded Mandates Reform Act Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104—4, estab- lishes requirements for Federal agencies to assess the effects of their regulatory actions on State, lo- cal, and tribal governments and the private sec- tor. Under section 202 of the UMRA, EPA gener- ally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures to State, local, and tribal gov- ernments, in the aggregate, or to the private sec- tor, of $100 million or more in any one year. Be- fore promulgating an EPA rule for which a writ- ten statement is needed, section 205 of UMRA 104a generally requires EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost- effective, or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows EPA to adopt an alternative other than the least costly, most cost-effective or least burdensome alterna- tive if the Administrator publishes with the final rule an explanation why that alternative was not adopted. Before EPA establishes any regulatory re- quirements that may significantly or uniquely affect small governments, including tribal governments, it must have developed under section 203 of the UMRA a small government agency plan. The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and time- ly input in the development of EPA regulatory proposals with significant Federal intergovernmen- tal mandates, and informing, educating, and ad- vising small governments on compliance with the regulatory requirements. EPA has determined that this rule does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and tribal governments, in the aggregate, or the private sector in any one year. Thus, today’s rule is not subject to the requirements of sections 202 and 205 of the UMRA. For the same reason, EPA has determined that this rule contains no regulatory requirements that might significantly or uniquely affect small governments. Thus, today’s 105a rule is not subject to the requirements of section 203 of UMRA. E. Executive Order 13132: Federalism Executive Order 13132, entitled “Federal- ism” (64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the re- lationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of gov- ernment.” This final rule does not have federalism implications. It will not have substantial direct ef- fects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. EPA is merely identifying two circumstances in which the application of a pesticide to waters of the United States consistent with all relevant requirements under FIFRA does not constitute the discharge of a pollutant that requires a NPDES permit under the Clean Water Act. Thus, Executive Order 13132 does not apply to this rule. In the spirit of Executive Order 13132, and consistent with EPA policy to promote communi- 106a cations between EPA and State and local govern- ments, EPA specifically solicited comment on the proposed rule from State and local officials. EPA additionally consulted with state officials in the development of the final rule. Especially impor- tant were consultations regarding the manner in which States in the Ninth Circuit currently permit pesticides in response to the Talent decision and how states use TMDLs and other authorities to address pesticide residuals. F. Executive Order 13175: Consultation and Coordi- nation With Indian Tribal Governments Executive Order 13175, entitled “Consulta- tion and Coordination with Indian Tribal Gov- ernments” (65 FR 67249, November 6, 2000), re- quires EPA to develop an accountable process to ensure “meaningful and timely input by tribal offi- cials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive Order to include regulations that have “substantial di- rect effects on one or more Indian tribes, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal govern- ment and Indian tribes.” This final rule does not have tribal implica- tions. It will not have substantial direct effects on tribal governments, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities be- tween the Federal government and Indian tribes, as specified in Executive Order 13175. EPA is 107a merely identifying two circumstances in which the application of a pesticide to waters of the United States consistent with all relevant re- quirements under FIFRA does not constitute the discharge of a pollutant that requires a NPDES permit under the Clean Water Act. Thus, Executive Order 13175 does not apply to this rule. Moreover, in the spirit of Executive Order 13175, and con- sistent with EPA policy to promote communica- tions between EPA and tribal governments, EPA specifically solicited comment on the proposed rule from tribal officials. G. Executive Order 13045: Protection of Children From Environmental Health and Safety Risks Executive Order 13045: “Protection of Chil- dren from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997) applies to any rule that: (1) Is determined to be “economically sig- nificant” as defined under Executive Order 12866, and (2) concerns an environmental health or safety risk that EPA has reason to believe may have a dis- proportionate effect on children. If the regulatory action meets both criteria, the Agency must evalu- ate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other poten- tially effective and reasonably feasible altcrnatives considered by the Agency. This regulation is not subject to Executive Order 13045 because it is not economically signifi- cant as defined under Executive Order 12866 and because the Agency does not have reason to believe the environmental health and safety risks 108a addressed by this action present a disproportionate risk to children. The regulation only interprets the legal scope of the NPDES permit requirement un- der the CWA and does not change how pesticide applications are addressed under FIFRA. H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Sup- ply, Distribution, or Use This rule is not subject to Executive Order 13211, “Actions Concerning Regulations That Sig- nificantly Affect Energy Supply, Distribution, or Use” (66 FR 28355 (May 22, 2001)). The only ef- fect of this rule is to identify two circumstances in which the application of a pesticide to waters of the United States consistent with all relevant re- quirements under FIFRA does not constitute the discharge of a pollutant that requires a NPDES permit under the Clean Water Act. I, National Technology Transfer and Advancement Act Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (“NTTAA’”), Public Law 104-1138, section 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus stan- dards are technical standards (e.g., materials spe- cifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standard bodies. The NTTAA directs EPA to provide Congress, through 109a OMB, explanations when the Agency decides not to use available and applicable voluntary consen- sus standards. This rulemaking does not involve technical standards. J. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 et seg., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally pro- vides that before a rule may take effect, the agency promulgating the rule must submit a rule re- port, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required in- formation to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2). This rule will be effective January 26, 2007. List of Subjects in 40 CFR Part 122 Environmental protection, Administrative practice and procedure. Confidential business in- formation, Hazardous substances, Reporting and recordkeeping requirements, Water pollution con- trol. Dated: November 20, 2006. Stephen L. Johnson, Administrator. 110a w For the reasons set forth in the preamble, chap- ter | of title 40 of the Code of Federal Regula- tions is to be amended as follows: PART 122—EPA ADMINISTERED PERMIT PROGRAMS: THE NATIONAL POLLUTANT DISCHARGE ELIMINATION SYSTEM ws 1. The authority citation for part 122 continues to read as follows: Authority: The Clean Water Act, 33 U.S.C. 1251 et seq. = 2. Section 122.3 is amended by adding paragraph (h) to read as follows: § 122.3 Exclusions. * * * * * (h) The application of pesticides consistent with all relevant requirements under FIFRA (..e., those relevant to protecting water quality), in the following two circumstances: (1) The application of pesticides directly to waters of the United States in order to control pests. Examples of such applications include appli- cations to control mosquito larvae, aquatic weeds, or other pests that are present in waters of the United States. (2) The application of pesticides to control pests that are present over waters of the United States, including near such waters, where a por- llla tion of the pesticides will unavoidably be depos- ited to waters of the United States in order to target the pests effectively; for example, when insecticides are aerially applied to a forest can- opy where waters of the United States may be present below the canopy or when pesticides are applied over or near water for control of adult mos- quitoes or other pests. [FR Doc. E6-20002 Filed 11-24-06; 8:45 am] BILLING CODE 6560-50-P ll2a APPENDIX D No. 06-4630 (and consolidated cases) UNITED STATES COURT OF APPEALS SIXTH CIRCUIT The NATIONAL COTTON COUNCIL OF AMERICA, et al., Petitioners, v. UNITED STATES ENVIRONMENTAL PROTECTION AGENCY, Respondent. On Petition for Review of Final Action of the United States Environmental Protection Agency RESPONDENT UNITED STATES ENVIRONMENTAL PROTECTION AGENCY’S MOTION FOR STAY OF MANDATE JOHN C. CRUDEN Acting Assistant Aitorney General ALAN D. GREENBERG Attorney, U.S. Department of Justice Environmental & Natural Resources Division 1l3a 1961 Stout St. — 8" Floor Denver, CO 80294 (303) 844-1366 Of Counsel: MINDY NIGOFF U.S. Environmental Protection Agency April 9,2009 Washington, DC 20460 ll4a TABLE OF CONTENTS [OMITTED] TABLE OF AUTHORITIES (OMITTED) 115a INTRODUCTION Respondents U.S. Environmental] Protection Agency and Lisa P. Jackson (collectively, “EPA”) move, in accordance with Fed. R. App. P. 41(d), for a stay of the mandate in this case until April 9, 2011.' EPA seeks this stay to avoid significant disruption to EPA and the 46 states that, along with the U.S. Virgin Islands, administer the Clean Water Act’s National Pollutant Discharge Elimination System (“NPDES”) permit programs. EPA also seeks this stay to avoid significant disruption among the hundreds of thousands of persons and businesses nationwide who apply pesticides to, over, or near wa- ters of the United States without NPDES permits and now, as a result of this Court’s decision, will need to obtain permits in order to continue doing so consistent with the Clean Water Act. The af- fected pesticide applicators include local govern- ment entities that spray to and over waters to control mosquitoes, farmers who apply pesticides to eradicate aquatic pests, foresters who aerially spray over waters to prevent outbreaks of timber pests, and the U.S. Coast Guard, which sprays to kill insects that interfere with the maintenance of navigation devices. As a result of this Court’s decision, almost all of these pesticide applications will likely be ille- gal under the Clean Water Act unless and until ' EPA previously moved for an extension of time in which to file a petition for rehearing. On February 25, 2009, the Court granted EPA’s motion for an extension to April 9, 2009. EPA has decided not to seek rehearing of the Court’s deci- sion in this case. Instead, EPA requests through this motion a stay of issuance of the mandate until April 9, 2011. 116a EPA and the non-federal permitting authorities is- sue NPDES permits that authorize and regulate pes- ticide applications consistent with the requirements of the Clean Water Act. EPA has already received numerous inquiries from States and pesticide applica- tors asking how they should proceed if permits cover- ing the application of pesticides to, over, or near wa- ters of the United States are not issued prior to the issuance of the mandate. Neither EPA nor the non-federal NPDES permitting authorities currently have in place permits capable of addressing the many pesticide applications affected by this Court’s decision. These permitting authorities do not have the re- sources to immediately process and issue thou- sands of individual permits for each person who now needs a NPDES permit for a pesticide application to, over, or near a water of the United States. As a re- sult, EPA intends to issue (and anticipates that the States will issue) general NPDES permits to address these applications of pesticides. EPA and authorized States issue general permits to address a large number of similarly situated dischargers in lieu of issuing individual permits to each discharger. Both the Environmental Petitioners and this Court re- ferred tu the potential use of general permits as a means to allow uses of aquatic pesticides. Envi- ronmental Petitioners’ Opening Brief at 57-60; Nat7 Cotton Council v. EPA, 553 F.3d 927, 930-3 1 (6th Cir. 2009). The issuance of general permits, however, takes time. The development of a general permit for pesticide pollutant discharges will require in-depth environmental and engineering analyses. EPA must identify the types of pesticides and applications that 117a require permit coverage, and it must develop per- mit conditions sufficient to meet Clean Water Act requirements. EPA must give public notice of a draft permit, provide for public comment, and re- spond to those public comments prior to issuing the permit. EPA also plans to work with nonfederal permitting authorities to assist them in develop- ing their own NPDES general permits. In addition, EPA and the non-federal permitting authorities must inform and educate the regulated commu- nity, who will need to conform their practices to the permits’ requirements after it is issued. As explained in this motion, EPA estimates this ad- ministrative process — development, proposal and issuance of general permits — will take two years. Until the issuance of appropriate general permits, affected people and businesses will not likely be able to obtain permit coverage for the application of pesticides to, over, or near waters of the United States. Thus, probably for the next 24 months, thousands of pesticide applicators face the unpalatable choice of either not applying pesticides to, over, or near waters of the United States or fac- ing the involving risk of citizen suits and enforcement actions for discharging pesticides without a NPDES permit. To avoid the disruption to permitting au- thorities, mosquito abatement programs, farmers, foresters, and others, EPA requests the Court to exercise its equitable discretion and stay its mandate until April 9, 2011 to allow EPA and authorized permitting authorities sufficient time to develop and issue Clean Water Act permits containing appro- priate terms to govern the discharge of pesticide pol- lutants to waters of the United States. 118a BACKGROUND Since the enactment of the Clean Water Act in 1972, EPA has not required persons applying pesticides directly to or over waters of the United States for the purpose of controlling pests in or over those waters to obtain a NPDES permit.? See 71 Fed. Reg. 68,483, 68,484 (Nov. 27, 2006). In 2006, EPA issued a final rule titled “Application of Pesti- cides to Waters of the United States in Compli- ance with FIFRA,” 71 Fed. Reg. 68,483 (Nov. 27, 2006). Under this rule, which was challenged by petitioners in this case, EPA identified two circum- stances in which the application of pesticides consis- tent with all relevant requirements under FIFRA to or over, including near, waters ol the United States is not the discharge of a pollutant and, therefore, does not require an NPDES permit. Jd. at 68,485. On January 7, 2009, the Court issued an opinion granting in part and denying in part the 2 The Court, in its opinion, referenced pesticide labels in use for over 30 years that stated that the pesticide could not be discharged into water bodies unless in accordance with an NPDES permit. Nat? Cotton Council, 553 F.3d at 931. This la beling requirement addressed pesticides present in waste streams, not the application of pesticides to target pests. Fur- ther, although pesticides in return flows from irrigated agri- culture or in agricultural storm water discharges may be pollut- ants in certain circumstances, Congress expressly excluded these discharges from NPDES permitting requirements. 33 U.S.C. § 1342(1)(1) (prohibition on requiring a Clean Water Act permit for discharges composed entirely of return flows from irmngated agriculture); § 1362(14) (defining point source not to include agri- cultural storm water discharges). 3 “FIFRA” is the Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. §§ 136, et seq. 119a environmental petitioners’ petitions for review and denying the industry petitioners’ petitions. Nat Cotton Council, 553 F.3d at 940. The Court found EPA’s interpretation of the statutory terms “pollut- ant” and “point source” contrary to the text of the Clean Water Act. Jd. at 935-40. It held that “dis- chargers of pesticide pollutants are subject to the NPDES permitting program in the Clean Water Act.” Id. at 940. The Court vacated EPA’s rule. Id. LEGAL ARGUMENT A. This Court Has Discretion to Stay the Mandate to Avoid Disrupting Regulatory Programs and the Regulated Community. A court of appeals that finds an agency rule contrary to law and vacates the agency rule may stay its mandate to allow the agency to take addi- tional regulatory action to avoid substantial disrup- tion to the regulated program and the regulated community. See Chamber of Commerce v. SEC, 443 F.3d 890, 909 (D.C. Cir. 2006) (staying mandate for 90 days to allow SEC to address matter and avoid substantial disruption of mutual fund industry); Jn- dependent U.S. Tanker Owners v. Dole , 809 F.2d 847, 854-55 (D.C. Cir. 1987) (withholding mandate for six months to allow agency to undertake further proceedings and avoid further disruption of domestic shipping market). When considering whether to stay the mandate, courts examine the “seriousness of the order’s deficiencies and the disruptive consequence of an interim change that may itself be changed.” Al- lied Signal v. U.S. Nuclear Regulatory Comm'n, 988 F.2d 146, 150-51 (D.C. Cir. 1993). 120a The Ninth Circuit Court of Appeals, in a case presenting nearly identical vacatur issues to the one before this Court, recently affirmed a district court decision that postponed vacatur of a Clean Wa- ter Act permitting exclusion for 24 months to provide time for EPA to issue appropriate NPDES permits. Northwest Environmental Advocates v. EPA, 537 F.3d 1006, 1010 (9th Cir. 2008). The district court in Northwest Environmental Advocates considered a challenge to an EPA regulation that excluded certain vessel discharges from NPDES permit require- ments. Jd. The district court found that the dis- charges of pollutants, including ballast water, from non-military vessels must occur only under the regu- lation of an NPDES permit. /d. Rather than vacating the regulation immediately, however, the district court ordered the regulatory exemption vacated no later than a date two years after issuance of its or- der. Id. at 1025-26. The district court’s analysis supporting a de- lay in vacating the rule, quoted and affirmed by the Ninth Circuit, is of particular relevance to this case. The district court recognized that an immedi- ate vacatur of a regulatory structure that had stood for over 30 years was a practical impossibility. Jd. at 1026. Thus, the district court framed its task as balancing the need for prompt action to address en- vironmental harm “against the need to allow EPA adequate freedom to address a complicated issue.” /d. at 1026. The district court also recognized that EPA has an expertise in the area that the court cannot approach. Jd. Although the district court found the regulation excluding vessel discharges from NPDES permitting requirements inconsistent with the Clean Water Act, the court sought to avoid the significant harm to shipping and the economy if ballast water 12la could not be discharged from vessels without a permit and no permits were available to authorize the discharges. Jd. at 1026-27. The district court and court of appeals recognized the substantial task presented to EPA - to “bring discharges previously ex- empted by § 122.3{a) within the permitting process of the CWA.” Id. at 1026. The Ninth Circuit there- fore affirmed the district court’s decision to withhold vacating the rule for 24 months to provide appropri- ate time to EPA to address permitting issues. For the reasons set forth in the next section, this Court should withhold its mandate for a similar period. B. This Court Should Stay Its Mandate Until April 9, 2011, to Enabie EPA and the Authorized States to Issue General Permits to Regulate Dis- charges of Pesticide Pollutants To, Over, or Near Waters of the United States. Unless stayed, this Court’s mandate will ef- fectively prohibit for many months the discharge of almost all pesticides to, over, or near waters of the United States. Because the Court determined that all biological pesticides are pollutants under the Act, the application of all biological pesticides to, over, or near waters of the United States will be il- legal unless applied in accordance with a NPDES permit. Nat? Cotton Council, 553 F.3d at 937-38. In addition, because virtually all applications of chemical pesticides leave pesticide pollutants in the form of excess or residual quantities, almost all ap- plications of chemical pesticides to, over, or near wa- ters will now require NPDES permits. Jd. at 938-40. There is not currently in place a Clean Water Act general permit for all pesticide applications ad- 122a dressed by this Court’s decision, and the individual permitting option is not a practical avenue at this time. In short, the removal of the exclusion for pesti- cide discharges creates the same regulatory dilemma that existed in the context of vessel discharges. A sim- ilar judicial response is appropriate. As explained in the next section, an immedi- ate vacatur of the Rule would have significant dis- ruptive consequences to the NPDES permitting programs of EPA and the 47 non-federal permitting authorities responsible for regulating discharges of pollutants. In the following section, EPA explains that, until the permitting authorities establish ap- propriate permitting programs, the vacatur of the rule will have significant disruptive consequences to public health and welfare by limiting the application of pesticides to control mosquitoes, agricultural pests, invasive species and other undesired animals and plants. 1. The Disruptive Conse- quences to Permitting Au- thorities Requires a Stay of the Mandate. Although the rule the Court vacated had only been in place since 2006, the rule codified what had been EPA’s practice during the more than 35 years EPA has administered the Clean Water Act. During that time, EPA has never issued a single NPDES permit for pesticide applications to or over waters of the United States to target pests in or over the water. See 71 Fed. Reg. at 68,484; Gem County Mosquito Abatement Dist. v. EPA, 398 F. Supp. 2d 1, 5 (D.D.C. 2005). Similarly, the 47 non-federal permitting authorities have not issued permits for 123a pesticide applications to or over waters of the United States except in limited cases, primarily in response to recent litigation. Because of this Court’s opinion, however, EPA and the non-federal authorities must now issue either individual permits or general permits for pesticide pollutant discharges to allow and regulate appropriate applications of pesticides to, over, or near waters of the United States. Vacatur of the rule prior to the issuance of permits will have significant disruptive conse- quences to the regulatory program. The use of individual permits to authorize the hundreds of thousands of discharges of pesticide pol- lutants to waters of the United States that occur an- nually does not offer a feasible approach. Individual permits are issued based upon the permittee sub- mitting a permit application. The permitting au- thority must then evaluate appropriate terms and conditions to comply with relevant technology- based effluent limits and applicable water quality standards, prepare a draft permit and accompany- ing fact sheet that contains the rationale for the permit conditions, and provide public notice and a public comment period of at least 30 days. See 33 U.S.C. §§ 1311(b)(1)(C), 13811(b)(2)(A); 40 C.F.R. §§ 122.44(d); 124.6, 124.8. 124.10(b). If a State is the permitting authority, a proposed individual permit must then be sent to EPA, which may make com- ments, objections or recommendations for up to an additional 90 days. 40 C.F.R. § 123.44. Requiring individual permits for all applica- tors of pesticides to, over, or near waters of the United States would seriously disrupt NPDES pro- grams. The permitting authorities cannot handle the addition of pesticide applicators to the individ- 124a ual permit program. Nationally, approximateiy 45,700 facilities are authorized to discharge under individual permits. Declaration of James A. Hanlon, attached as Exhibit 1, (“Hanlon Decl.”) 4 11. EPA estimates that 365,000 pesticide applicators perform approximately 5.6 million pesticide applications an- nually to, over, or near waters of the United States to control pests such as mosquitoes and gypsy moths, combat algae, weeds and other undesirable vegetation and attack invasive species such as zebra mussels. Id. 4 {| 4, 5. Including these dischargers in the individual permit programs would increase these programs by a factor of eight. In addition, the consideration and issuance of an individual permit typically takes many months. This delay could effec- tively result in a denial of coverage in many cases because the need for pesticide applications often cannot be anticipated months in advance. ld. 4 6; see Declaration of Teung F. Chin, PhD, attached as Exhibit 2, (“Chin Decl.”) 44 2, 6-7, 10-11. Thus, the addition of potentially hundreds of thousands of in- dividual permit applications from pesticide applica- tors would likely overwhelm permit authorities and prove ineffective in providing timely authori- zations. A general permit system does not offer a short- term solution to the permit coverage dilemma. Where there are a large number of similarly situ- ated dischargers, EPA may issue a general permit covering a category of dischargers in lieu of issuing individual permits to each discharger. 40 C.F.R. § 122.28; see South Florida Water Management Dis- trict v. Miccosukee Tribe of Indians, et al., 124 S.Ct. 1537, 1545 at Fn * (2004) (recognizing the role EPA’s general permits serve in reducing administrative burdens). 125a The procedures required for issuing a general permit, however, require a significant commitment of time and resources. Like individual permits, gen- eral permits must contain conditions necessary to meet Clean Water Act requirements. 40 C.F.R. §§ 122.44(a), (d).4 The permitting authority prepares a fact sheet that includes a basis for the draft permit conditions. 40 C.F.R. § 124.8. The permitting author- ity must give the public notice of the draft permit and provide at least 30 days for public comment. 40 C.F.R. § 124.10(b). Any interested person may submit written comments on the draft permit and may request a public hearing. 40 C.F.R. § 124.11. The permitting authority must issue a response to comments when it issues the final permit. 40 C.F.R. § 124.17; see 40 C.F.R. § 122.28(b)(1) (general per- mits may be issued in accordance with the applica- ble requirements of Part 124). For the reasons set forth in Mr. Hanlon’s declaration, EPA estimates that the critical steps required to issue a general permit to cover applica- tions of pesticide pollutants to, over, or near waters of the United States will take an additional 24 months. Hanlon Decl., {| 7, 18-36. EPA com- menced the general permit process upon issuance of this Court’s opinion in January, when it started an initial review of available data associated with potential pesticide point sources. Jd. 94] 4, 21. EPA also commenced review of existing state pesticide permits. Jd. | 21. EPA is working to identify the dif- ferent types of pesticide applications to, over, or 4 The process for issuing a gene:al permit and indi- vidual permit are generally the same; however, an individual permit requires a public notice period for each permit. 126a near waters of the United States, and the number and frequency of these applications. Jd. This in- cludes examining the different methods of pesti- cide applications and identifying best manage- ment practices that applicators employ to mini- mize the amount of pesticides that enters the wa- ter. Id. This analysis potentially forms the basis of the required technology-based effluent limitations for the different categories of pesticide applications that would be covered under a general permit. Jd. Because EPA has not previously developed effluent limitation guidelines for the direct application of pesticides, EPA must develop such effluent limita- tions based upon its best professional judgment us- ing the appropriate levels of controls (e.g., best prac- ticable control technology) established in the Clean Water Act and associated regulations. Id. {| 26; See 33 U.S.C. § 13814(b); 40 C.F.R. § 125.3(c)(2). After undertaking this data yathering, analysis and assessment, EPA will prepare a draft general permit. Hanlon Decl. 94) 25-29. EPA must publish any proposed general permit in the Federal Register and anticipates providing a 90-day public comment period because of the significant public in- terest in this issue. Jc. | 30. EPA must prepare a written response to all significant comments submit- ted, which EPA estimates will take substantial time given the public interest. /d. 4 31. Further, EPA must coordinate with other federal agencies and States to ensure that any gen eral permit complies with other federal and state re- quirements, EPA may be required to engage in con- sultation to comply with the Endangered Species Act. Hanlon Decl. 4] 34. In accordance with Clean Water Act Section 401, 33 U.S.C. § 1341, EPA 127a must seek certification of the permit from all States, territories and tribes where discharges au- thorized under EPA’s permit may occur. Jd. {| 32. EPA must also assure consistency with the Coastal Zone Management Act. Jd. {| 33. Each of these co- ordination activities will require significant time and resources to complete. Jd. | 32-24. Finally, EPA will need to coordinate with and assist 46 States and the U.S. Virgin Islands, each of which will likely seek to issue its own general per- mits under their NPDES permit authority. /d. 4 7, 13. A general permit issued by EPA will provide permit coverage only in the four States in which EPA is the permitting authority, plus the United States’ territories, tribal lands and federal facilities. Id. 4 7. Although the States will likely develop their general permits contemporaneously with EPA’s de- velopment of its own permit, as a practical matter, States are unlikely to finalize their own permits until EPA issues a general permit that serves as a na- tional model, The States must still complete their own notice and comment proceedings. After the general permit is drafted, EPA and non-federal permitting authorities will have to ensure proper implementation of the general permit through outreach, Hanlon Decl. 4 36. The outreach will pro- vide applicators, who have not previously been sub- ject to NPDES permitting, time to bring their prac- tices into conformance with the final permit and, if necessary, to submit written notice to seck coverage under the general permit. In sum, EPA estimates that a stay of the man- date until April 9, 2011 will be sufficient to enable it and the non-federal permitting authorities to de- velop, propose and issue appropriate general per- 128a mits to authorize and regulate certain pesticide dis- charges to waters of the United States consistent with CWA requirements. Without such permitting authority, EPA and the other permitting agencies will experience disruptive consequences to their NPDES permit programs. In addition, significant disruptions to the regulated community, discussed in the next section, will likely occur. 2. Issuance of the Mandate at this Time Likely Will Dis- rupt Efforts to Protect Public Health, Agriculture and Oth- er Historical Uses of Pesti- cides. By issuing a mandate vacating the Rule ei- ther immediately or prematurely, the Court risks serious disruption of public health initiatives, ag- riculture and other activities. Numerous public entities apply pesticides to, over, or near waters of the United States to reduce risks posed by mos- quitos. Agriculture and timber industries apply pesticides to, over, or near waters to combat devas- tating pests. Federal agencies use pesticides to sup- port American agriculture and to facilitate naviga- tion on the nation’s waters. Virtually all of these pesticide users will have to make a difficult choice apply pesticides in violation of the Clean Water Act or suspend pesticide uses — if the rule is vacated before NPDES permits are available to authorize appropriate uses. Hundreds of local government agencies apply pesticides to, over, or near waters of the United States to control mosquito populations. Approxi mately 1,200 applicators nationwide, through an 129a estimated 19,000 applications annually, spray mosquito larvicides directly to water to kill mosquito larvae in the water. Hanlon Decl. "| 16. These same applicators, through an estimated 461,000 applica- tions annually, aerially spray mosquito adulti- cides, often over waters of the United States. Jd. Mosquitos spread infectious diseases, including West Nile virus and strains of encephalitis. Jd. 4 17. Unchecked mosquito populations also ad- versely impact outdoor activities, tourism and the general public health and welfare. Because these mosquito abatement activities require in many in- stances the application of pesticides to, over, or near waters of the United States, absent a stay of man- date, they will not likely occur until permitting au- thorities issue permits. Issuance of the mandate prior to the avail- ability of permits will also disrupt the agriculture industry and the activities of the Department of Ag- riculture. Agricultural production requires the flexibility to respond quickly and appropriately to changing conditions, and the time required to obtain an individual NPDES permit will hamper a far- mer’s ability to respond to needed changes in crops or pesticides. Chin Decl., {| 2, 6-7. In addition, sev- eral Department of Agriculture agencies engage in applications of pesticides to, over, or near waters in fulfilling their responsibilities to respond to emerg- ing threats and emergency situations posed by pests. Jd. “4 9-11. The Forest Service and the An- imal and Plant Health Inspection Service rely on pesticides to prevent outbreaks of pests, and these efforts could be disrupted if the mandate is not stayec pending issuance of permits. /d. The Agricul- tural Research Service engages in research programs that could also be disrupted or damaged by an in- 130a ability to apply pesticides until issuance of an NPDES permit. Jd. {4 12-13. Issuance of the mandate also may adverscly impact navigation on the nation’s waters. The Coast Guard uses pesticides to address wasps and other stinging insects that frequently nest in navigational devices and interfere with maintenance of the de- vices. Declaration of Erik S. Anderson, attached as Exhibit 3, {| 5. The Coast Guard applies pesticides to navigational aides to prevent poisonous plants from interfering with the functions of these naviga- tional devices. Id. {| 6. These navigational aids are often in or adjacent to waters of the United States, and the pesticides used by the Coast Guard may, therefore, leave residual amounts in the water after use. Id. | 4. As a result, issuance of the mandate will require the Coast Guard to suspend pesticide applications until a permit is available to authorize its applications, causing additional risks to naviga- tion in the interim. Jd. | 7. Thus, not staying the mandate will have po- tentially serious and disruptive consequences on sig- nificant sectors of the national economy. Even if EPA and the States exercise enforcement discretion and do not enforce the Clean Water Act against applica- tors of pesticide pollutants who apply consistent with FIFRA, pesticide applicators are subject to suits brought by citizens seeking to enforce the Clean Water Act. See 33 U.S.C. § 1365. For exam- ple, each of the pesticide application cases cited in this Court’s opinion arose from a citizen suit. The threat of citizen suits has the potential to halt most pesticide applications to, over, or near waters of the United States until permit authorization is availl- able. 13la C. The Potential Harm to Waters of the United States By Leaving the Rule in Place Does Not Require Issuance if the Mandate. Postponing issuance of the mandate until appropriate permits are in place should not result in any unreasonable harm to waters of the United States. During this interim period, the final rule will exclude from permitting requirements only those pesticide applications undertaken consistent with FIFRA requirements. FIFRA requirements are established to avoid any unreasonable risk to hu- mans or the environment. See 7 U.S.C. §§ 136a(c)(5) & (7), § 136(bb) . Leaving the rule in place for an additional 24 months will mean that pes- ticide application practices employed in recent dec- ades will continue for an additional short period while EPA and the States work to develop and is- sue appropriate NPDES permits. Leaving the rule in place will also avoid the disruption caused by an interim change in practice that will likely again be changed. See Allied Signal, 988 F.2d at 150-51. Environmental Petitioners in this case did not advocate a ban on all pesticide ap- plications to, over, or near waters of the United States. Rather, they argued that such pesticide ap- plications should be subject to Clean Water Act NPDES permitting requirements. See Environ- mental Petitioners’ Opening Brief at 44-49, 57. EPA and the States will likely issue general permits to authorize some applications of pesticide pollut- ants to, over, or near waters of the United States subject to certain terms and conditions. This Court should not issue a mandate that will effectively ban application of all pesticides to, over, or near waters 132a of the United States for the interim period before the permitting agencies can issue permits that au- thorize certain pesticide pollutant discharges. CONCLUSION For the reasons set forth above, the Court should stay issuance of its mandate in this case un- til April 9, 2011. 133a CERTIFICATE OF SERVICE [OMITTED] 134a EXHIBIT 1 IN THE UNITED STATES COURT OF APPEALS FOR THE SIXTH CIRCUIT THE NATIONAL COTTON COUNCIL OF AMERICA, et al. Appellant, ws UNITED STATES ENVIRONMENTAL PROTECTION AGENCY, Nos. 06-4630; 07- 3180/318 1/3 182/3183/ 3184/3185/3186/3187/ 3191/3236 Appellee. Nee meee eee ee eee See” DECLARATION OF JAMES A. HANLON [, James A. Hanlon, declare that the follow- ing statements are true and correct to the best of my knowledge, information and belief, and are based on my personal knowledge and information supplied to me by employees of the United States 135a Environmental Protection Agency (KPA or Agen- cy) under my supervision and information pro- vided by my colleagues from EPA’s Office of Pesti- cides Program (OPP). INTRODUCTION |. I am James A. Hanlon, Director of the Wastewater Management in EPA’s Office of Wa- ter. I have served as the Office Director since April of 2002. As the Director of the Office of Wastewater Management (OWM), I direct the EPA office responsible fcr national program direc- tion to the National Pollutant Discharge Elimina- tion System (NPDES) permit program, including oversight of authorized State and _ Territorial NPDES programs. OWM has oversight responsibilities and provides technical assistance supporting EPA re- gional water programs. OWM also administers federal financial and technical assistance for publicly owned treatment works (e.g., municipal sewage collection sys- tems and treatment plants). I supervise a staff of ap- proximately 110 permanent full-time and part-time federal employees. OWM's annual program (operating) budget for fiscal year 2009 is approximately $28 million. OWM's operating budget also supports the manage- ment of State grants which total near $950 million. 2. Prior to my current position, I served as the Deputy Office Director of the Office of Science and Technology (OST) in EPA's Office of Water beginning in 1991. OST is responsible for the scientific and tech- nical basis for federal water quality and safe drinking water programs, including establishment of national ef- fluent limitations guidelines and analytical test meth- ods. OST also provides scientific and technical support 136a to other Offices with program implementation responsibili- ties within the Office of Water, including OWM, the Of- fice of Wetlands, Oceans, and Watersheds, and the Office of Ground Water and Drinking Water. I have worked for EPA for more than 36 years. I received a Bachelor of Science degree in Civil Engineering from the University of Illinois and a Masters of Business Administration degree from the University of Chicago. I am a registered Professional Engineer in the State of Illinois. 3. I have read the Sixth Circuit Court of Appeal's Opinion of January 7, 2009, in National Cotton Council of America, ct_al., v. EPA. | understand that the En- vironmental and Industry Plaintiffs challenged EPA's Final Rule: Apphecation of Pesticides to Wa- ters of the United States in Compliance with FIFRA ("Final Rule") as codified at 40 C.F.R. 122.3(h), which excludes from NPDES permitting those pesticide ap- plications consistent with FIFRA requirements that are applied to or over, including near, waters of the United States. As a remedy in this litigation, I understand that the Court has determined that the Final Rule should be vacated. 4. Since January 7, 2009, EPA has been ana- lyzing the Court's decision and its impacts while also providing support to the states and communicating to sec- tors of the regulated community and environmental groups. I have heard first-hand the concern and confu- sion amongst the permitting authorities and pesticide applicators about who will be required to obtain a NPDES permit. EPA has determined that the Court's decision clearly impacts the following point source dis- charges to, over or near waters of the United Siates: dis- charges of chemical pesticides that leave a residual or ex- 137a cess and discharges of all biological pesticides. My staff has also worked with the OPP to clarify what pesticide use patterns will trigger a requirement to obtain an NPDES permit. At least the following large categories are covered when sprayed to, over, or near waters of the United States: e Mosquito larvicides * Mosquito adulticides « Herbicides used to control weeds in lakes and ponds ° Herbicides used to control weeds in irrigation systems and other waterways “ Herbicides used to control weeds along ditch banks in agricultural drainage systems a Insecticides used in wide-area insect suppression programs . Herbicides used in wide-area con- trol programs directed at aquatic invasive plant species . Herbicides, insecticides and oth- er pesticides used in forestry programs when applied over wa- ters of the United States. 5. Using available information sources, OPP estimated the number of pesticide applicators and applications for the identified use patterns identified 138a in paragraph 4. OPP estimates that these catego- ries represent approximately 365,000 applicators and 5.6 million applications a year. OPP has also provided information to characterize the pest con- trol needs which these pesticides address and the availability of other, non- pesticidal methods of controlling the target pests. Finally, OPP has provided information on the impacts of relying only on non-pesticidal methods of pest control. The in- formation developed by OPP appears in Appendix A. 6. Because of the large number of similarly situated discharges, EPA intends to issue a general permit to cover pesticide discharges covered by the Decision. Individual permits are designed to ad- dress discrete discharges from fixed locations and would require an individual public notice and comment pericd. In fact, I do not believe either EPA or states would be able to provide timely coverage to pesticide applicators using individual permits for nearly all of the types of pes- ticide applications covered by the Decision. Thus, as a practical matter, I believe that EPA and NPDES au- thorized states will not be able to provide applicators with a way to comply with the CWA's NPDES re- quirements without drafting a general permit for cov- ered application of pesticides. 7. A vacatur will require EPA and authorized states and territories to immediately develop NPDES permits that comply with NPDES regulatory require- ments found in 40 CFR Part 122 and described in more detail below. This process will take 2 years to ensure that all necessary NPDES permit requirements are met. This estimate is partly based on EPA's recent experi- ence in issuing the NPDES general permit for vessel 139a discharges, which took over 2 years to complete. Similarly, as discussed below, EPA is suggesting 24 months to de- velop a final NPDES pesticides general permit, including the time to work concurrently with authorized states and territories to draft and finalize their general permits si- multaneously with EPA. When EPA issues an NPDES permit, it is only effective in non-authorized states (4), in territories, Indian Country, and on federal facilities. It is very important that the authorized permitting authori- ties keep in step with EPA to ensure national compli- ance with the CWA. A stay would provide EPA and NPDES authorized states and territories the time necessary to develop, propose, and implement an NPDES permit that would satisfy the CWA requirements.’ 8. Vacatur of the rule before a NPDES permit can be issued by the permitting authority would place pesticide applicators in a vulnerable position where they would be subject immediately to potential citizen suits for violating the CWA if they discharge pesticide pollutants to, over or near waters of the United States. Moreover, the in- tentional discharge of pollutants without a permit could technically subject an applicator to criminal liabil- ity under the CWA, however, EPA would not expect crimi- nal charges to be brought during the time period prior to NPDES permitting authorities being able to make a permit available for pesticide applicators. Significant harm to public health could result if appiicators choose not to apply pesticides in order to reduce the risk of liabil- ity. Some states have informed us that applicators in their 1 EPA has authorized 46 States and 2 U.S. Virgin Islands to implement the NPDES program. Where, in this declaration I refer to authorized states, I am referring to the authorized states and the U.S. Virgin Islands. 140a states would not apply pesticides after the mandate in this case issues and prior to when a NPDES permit is available. A stay of the mandate until April 9, 2011 would prevent disruption to mosquito abatement programs, farming operations, forest management, irrigation dis- tricts, and other permittees. 9. For the reasons set out in this Declaration, | be- heve that the immediate vacatur of the Final Rule would cause significant disruption to both EPA's and author. ized states' NPDES permitting programs, as well as the regulated community and others including federal agen- cies. First, I will provide a detailed description of the sig- nificant adverse effects arising from an immediate vaca- tur. Second, I will explain the time intensive NPDES permit development process that gives rise to EPA's request that the Court stay the mandate until April 9, 2011 (24 months). ANTICIPATED IMPACTS TO EPA AND NPDES AUTHORIZED STATES AND TERRITORIES IF THE MANDATE ISSUES BEFORE NPDES GENERAL PERMIT IS ISSUED 10. The mandate, if it issues prior to the avail- ability of an NPDES permit, will effectively prohibit the discharge of almost all pesticides to, over or near waters of the United States. This would result in sub- stantial disruption for both EPA and the 47 authorized NPDES permitting authorities. If the Court's vacatur were to take effect before EPA and authorized states and territories are able to issue NPDES general per- mits, significant numbers of pesticide applicators would immediately be faced with discharging without a permit. There are significant legal risks (third—party citizen l4la suits) for any person determined to be discharging a pol- lutant into waters of the United States without a permit. Given these risks, I would predict that significant numbers of pesticide applicators would seek to obtain NPDES permits immediately upon issuance of the mandate, where the permitting authorities would not be prepared to respond. 11. NPDES authorized permitting authorities are concerned about whether they will have adequate re- sources to issue newly required permits that could potentially include hundreds of thousands of applica- tions in each state. The current universe of point sources requiring NPDES permits to discharge includes individual and general permittees. Nationally, ap- proximately 45,700 facilities are authorized to dis- charge under individual permits. Another 120,000 fa- cilities (including 70,000 vessels) are authorized under general permits for non-storm water discharges. Until the recent inclusion of the 70,000 vessel dischargers, in general, the universe of non-storm water permit- tees remained more or less stable since the inception of the NPDES Program in 1972. The 1987 CWA amend- ments established NPDES permit requirements for storm water discharges and the number of permits for stormwater discharges has increased significantly since then. EPA's 1990 and 1999 actions to promulgate the NPDES regulations for storm water substantially expanded the universe of point sources subject to NPDES permit requirements. Today, appreximately 7,000 municipalities (approximately 1000 in 1990 and another 6000 in 1999) require NPDES permits for dis- charges from municipal separate storm sewers; 270 of these need individual permits. Approximately 96,500 in- dustrial storm water point sources need permits. Approxi- mately 250,000 point sources of storm water associated 142a with construction activity require permits each year. Thus, the current total universe requiring NPDES per- mits (whether individual or general) is approximately 411,470 facilities. While most of the latter storm water discharges are authorized under general permits, more federal and state employees, resources, and expertise are now required to effectively manage the NPDES Program than ever before. \2. State governments have not matched the in- creased NPDES permitting work load with an increase in State environmental budgets. States have indicated that their environmental budgets have either been static or in decline for many years. In February 2003, the Na- tional Academy of Public Administrators confirmed an analysis by State environmental administrators dem- onstrating a budget shortfall of between seven hundred million to one billion dollars for implementation of State CWA programs. Understanding What States Need to Protect Water Quality, Report by a Panel of the National Academy of Public Administrators for the U.S. Envi- ronmental Protection Agency (2003). States generally have even fewer resources today. While the resources from the American Recovery and Reinvestment Act of 2009 will help fund needed infrastructure projects, ad- ditional funds under this Act are not available for NPDES activities. At the federal level, available re- sources for NPDES oversight activities have declined as well. In addition to increased numbers of point sources needing permits, other factors have increased pressure on NPDES permitting authorities including: (1) more complex legal challenges to entire programs and permits from the public, environmental groups, and indus- try; (2) increasing complexity of certain types of permits stemming from more sophisticated water quality-based regulatory requirements; (3) high employee attrition 143a rates in NPDES permitting staff, particularly state em- ployees; and (4) declining federal grant funding, in real terms, that has historically augmented the operating budgets of state permitting agencies. 13. In past efforts to bring new categories of point source discharges into the NPDES permitting pro- gram, EPA has built in time to allow states to up- date their NPDES programs to address the new cate- gory prior to requiring permits for that category. EPA has spoken with the states and they anticipate needing at least 24 months in order to develop and implement a federally compliant program, with a longer time being needed if state statutes or regulations must be revised prior to permits being issued to pesticide applicators. 2 | acknowledge the need to issue and implement this gen- eral permit in an expedient manner. Under ideal condi- tions, EPA would build time onto the end of EPA's gen- eral permit process to enable states to model their gen- eral permits on EPA's. However, in order to expedite the process, here EPA plans on working concurrently with the states so they may simultaneously be working on their general permits. * EPA usually allows State programs one to two years to modify their programs, which includes EPA review and ap proval. This time is necessary for states to conform to changes in the Federal program. The timeframe typically depends on whether changes are required to State regulations or to statutes. See. e.g., 40 C.F.R. §123.62(e). Most states will not have to modify their regulations because they can issue NPDES permits for pesticide applications covered by the Decision under their current au thorities, l44a ANTICIPATED IMPACTS TO PESTICIDE USERS IF THE MANDATE ISSUES BEFORE NPDES GENERAL PERMIT IS ISSUED 14. Pesticrde users are concerned with what applications will be covered and how the upcoming spring spraying season will be affected. Pesticide us- ers are extremely concerned that once the mandate is effective, they will become immediately subject to the re- quirement to have an NPDES permit and without one, will be subject to enforcement, and/or liable for citizen suits. If a pesticide applicator 1s required to have an NPDES permit, but cannot obtain one because the per- mitting authority is unable to issue a timely permit, an applicator would face a difficult choice. If the appli- cator chooses to apply the pesticide, he would risk being in violation of the CWA which would expose him to penal- ties of up to $32,500 a day. Alternatively, an applica- tor could decide not to apply a pesticide. The impact of not using a pesticide would depend on many factors, in- cluding the type and extent of the pest problem, the na- ture of the harm caused by the pest, and whether non- pesticidal alternatives were available to address the pest problem. The Court's vacatur will potentially affect many types of pesticide applicators who are not accustomed to obtaining NPDES permits while also requiring permitting authorities to develop and issue NPDES permits for a class of dischargers that they have little experience permitting. 15. The sheer number of applicators requesting NPDES permits will be significant. Although EPA is still considering aspects of the Court's decision that will ulti- mately affect the scope of the general permit, the Decision will clearly require large numbers of pesticide applica- tions to be covered under an NPDES general permit. 145a At the very least, when the Court vacates the Final Rule, NPDES permits will be needed for each pesticide application that is applied directly to or over waters of the United States to control pests. Examples of such pests include mosquitoes, which transmit infectious dis- eases such as encephalitis and West Nile Virus, gypsy moths, which defoliate forests causing growth loss or the death of trees; algae and weeds, which can clog irrigation canals reducing the amount of water available to irri- gate crops; and invasive species such as zebra mussels, which attach to and block water intakes for municipal water supplies and hydroelectric plants. Information from OPP shows that as many as 365,000 applicators per- form more than 5.6 million of these types of applica- tions annually, and would hence need NPDES permit coverage. ACTIVITIES PROJECTED TO BE IMPACTED BY A NPDES GENERAL PERMIT 16. To illustrate the magnitude, I have included the following information developed by OPP on the impacts of premature vacatur of the EPA Final Rule on mosquito control programs in the United States. Ac- cording to OPP, there are approximately 1200 Mos- quito Abatement Districts (MADs) and other agen- cies in the United States that apply mosquito control pesticides, and we estimate conservatively that each MAD employs at least one applicator. In addition, OPP's analysis of available information, including information from the National Agricultural Aviation Association, Florida Coordinating Council for Mosquito Control and EPA data, indicates that there are 99 million acre treatments with adulticides per year and 4 mil- lion acre treatments with larvicides. (An acre treat- ment represents a single application of a pesticide to 146a an acre of land or water. Multiple applications to the same acre result in multiple acre treatments.) Based on information from these data sources on the distribution of aerial and ground applications made, and the number of acres treated per application by air and ground, there are approximately 461,000 applications with adulticides and 19,000 applications of larvicides per year. Together, the instances of adulticide applica- tions, and the instances of larvicide applications yield the total estimate of 480,000 pesticide applications made annually by MADs and other agencies involved in mos- quito control. 17. Programs to control mosquito populations are important for protecting public health. Although most types of mosquito-transmitted diseases have been era- dicated from the United States, mosquitoes still carry some types of disease-causing organisms which they can transmit when they bite people or animals, notably in- cluding various forms of encephalitis, West Nile Virus, and dengue.? Disease carrying mosquito species are found throughout the U.S., especially in urban areas and coastal or in inland areas where flooding of low lands frequently occurs. 147a DEVELOPMENT OF A PROPOSED GENERAL PERMITS 18. The development of a legally defensible general permit for covered pesticide discharges will be a complex process that requires in-depth analyses of technical issues, including the technology options used by pesticide applicators and the impact of their applications on water quality. NPDES permit requirements can be found at 40 CFR Parts 122. The requirements for ap- proved NPDES state programs can be found in 40 CFR Part 123. Permit procedures can be found in 40 CFR Part 124. These regulations apply to EPA and to EPA NPDES programs administered by 47 state authorities. 19. The process to develop a general permit takes time (40 CFR Part 122, Subpart C). The devel- opment of a NPDES permit for pesticide pollutant dis- charges will require in-depth environmental and techni- cal analyses. The permitting authority must identify the types of pesticides and applicaticns that need permit cov- erage, and develop permit conditions necessary to meet the CWA requirements. The permitting authority must give public notice of a draft permit, provide for public comment, and respond to those public comments prior to issuing the permit. In parallel to these efforts, EPA the Agency plans to work with the state permitting authori- 3 A more in depth discussion of these types of diseases can be found at : Joint Statement on Mosquito Control in the United States from the U.S. Environmental Protection Agency (EPA) and the U.S. Centers for Disease Control and Prevention (CDC), at: http://www.epa.gov/opp00001 /hnealth/mosquitoes/mosquitojoint. htm 148a ties to assist them in developing their NPDES general permits. In addition, it is imperative for EPA and author- ized states to inform and educate the regulated commu- nity regarding the permit requirements and the process to obtain permit coverage before the Court's mandate issues. As explained in this declaration, EPA estimates this administrative process to develop, propose, issue, and implement general permits will take until April 9, 2011, or 24 months to complete. 20. EPA must adhere to the following critical steps described below in order to develop permit c [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40386017_1208%3A1. Public record. Not legal advice.