Application of Pesticides to Waters of the United States in Compliance With FIFRA, 68483-68492 [E6-20002]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 71, Number 227 (Monday, November 27, 2006)]
[Rules and Regulations]
[Pages 68483-68492]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-20002]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 122

[OW-2003-0063; FRL-8248-1]
RIN 2040-AE79


Application of Pesticides to Waters of the United States in 
Compliance With FIFRA

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: Today, EPA is issuing a regulation stating that the 
application of a pesticide in compliance with relevant requirements of 
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) does 
not require a National Pollutant Discharge Elimination System (NPDES) 
permit in two specific circumstances. The first circumstance is when 
the application of the pesticide is made directly to waters of the 
United States to control pests that are present in the water. The 
second circumstance is when the application of the pesticide is made to 
control pests that are over, including near, waters of the United 
States. This rulemaking is based on the Agency's interpretation of the 
definition of the term ``pollutant'' under the Clean Water Act (CWA) as 
not including such pesticides.
    This final rulemaking replaces EPA's previously published Interim 
and Final Interpretive Statements on the Application of Pesticides to 
Waters of the United States in Compliance with FIFRA. EPA's 
Interpretive Statement, published February 1, 2005, described the 
Agency's interpretation of the CWA with regard to the application of 
pesticides regulated under FIFRA that are applied to or over, including 
near, waters of the United States. On August 13, 2003, EPA provided 
public notice of and solicited public comment on an Interim Statement 
and incorporated that input into the Interpretive Statement. On 
February 1, 2005, EPA published the Interpretive Statement and proposed 
to codify its substance in EPA's NPDES regulations and solicited 
comment on that proposed action. Today's final rule is the result of 
this process.

DATES: These final regulations are effective on January 26, 2006.

ADDRESSES: EPA has established a docket for this action under Docket ID 
No. OW-2003-0063. All documents in the docket are listed online at 
https://www.regulations.gov. Although listed in the online docket, some 
information is not publicly available, i.e., Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. Certain other material, such as copyrighted material, is 
not placed on the Internet and will be publicly available only in hard 
copy form. Publicly available docket materials are available either 
online or in hard copy at the Water Docket, EPA/DC, EPA West, Room 
B102, 1301 Constitution Ave., NW., Washington, DC. The Public Reading 
Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, 
excluding legal holidays. The telephone number for the Public Reading 
Room is (202) 566-1744, and the telephone number for the Water Docket 
is (202) 566-2426.

FOR FURTHER INFORMATION CONTACT: For additional information, contact 
Jeremy Arling, Water Permits Division, Office of Wastewater Management 
(4203M), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: 202-564-2218, e-mail address: 
arling.jeremy@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does This Action Apply to Me?

    You may be affected by this action if you apply pesticides to or 
over, including near, water. Potentially affected entities may include, 
but are not limited to:

          Table 1.--Entities Potentially Regulated by This Rule
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                                                        Examples of
           Category                   NAICS         potentially affected
                                                          entities
------------------------------------------------------------------------
Agriculture parties--General    111 Crop           Producers of crops
 agricultural interests,         Production.        mainly for food and
 farmers/producers, forestry,                       fiber including
 and irrigation.                                    farms, orchards,
                                                    groves, greenhouses,
                                                    and nurseries.
                                113110 Timber      The operation of
                                 Tract Operations.  timber tracts for
                                                    the purpose of
                                                    selling standing
                                                    timber.

[[Page 68484]]

 
                                113210 Forest      Growing trees for
                                 Nurseries          reforestation and/or
                                 Gathering of       gathering forest
                                 Forest Products.   products, such as
                                                    gums, barks, balsam
                                                    needles, rhizomes,
                                                    fibers, Spanish
                                                    moss, ginseng, and
                                                    truffles.
                                221310 Water       Operating irrigation
                                 Supply for         systems.
                                 Irrigation.
Pesticide parties (includes     325320 Pesticide   Formulation and
 pesticide manufacturers,        and Other          preparation of
 other pesticide users/          Agricultural       agricultural pest
 interests, and consultants).    Chemical           control chemicals.
                                 Manufacturing.
Public health parties           923120             Government
 (includes mosquito or other     Administration     establishments
 vector control districts and    of Public Health   primarily engaged in
 commercial applicators that     Programs.          the planning,
 service these).                                    administration, and
                                                    coordination of
                                                    public health
                                                    programs and
                                                    services, including
                                                    environmental health
                                                    activities.
Resource management parties     924110             Government
 (includes State departments     Administration     establishments
 of fish and wildlife, State     of Air and Water   primarily engaged in
 departments of pesticide        Resource and       the administration,
 regulation, State               Solid Waste        regulation, and
 environmental agencies, and     Management         enforcement of air
 universities).                  Programs.          and water resource
                                                    programs; the
                                                    administration and
                                                    regulation of water
                                                    and air pollution
                                                    control and
                                                    prevention programs;
                                                    the administration
                                                    and regulation of
                                                    flood control
                                                    programs; the
                                                    administration and
                                                    regulation of
                                                    drainage development
                                                    and water resource
                                                    consumption
                                                    programs; and
                                                    coordination of
                                                    these activities at
                                                    intergovernmental
                                                    levels.
                                924120             Government
                                 Administration     establishments
                                 of Conservation    primarily engaged in
                                 Programs.          the administration,
                                                    regulation,
                                                    supervision and
                                                    control of land use,
                                                    including
                                                    recreational areas;
                                                    conservation and
                                                    preservation of
                                                    natural resources;
                                                    erosion control;
                                                    geological survey
                                                    program
                                                    administration;
                                                    weather forecasting
                                                    program
                                                    administration; and
                                                    the administration
                                                    and protection of
                                                    publicly and
                                                    privately owned
                                                    forest lands.
                                                    Government
                                                    establishments
                                                    responsible for
                                                    planning,
                                                    management,
                                                    regulation and
                                                    conservation of
                                                    game, fish, and
                                                    wildlife
                                                    populations,
                                                    including wildlife
                                                    management areas and
                                                    field stations; and
                                                    other administrative
                                                    matters relating to
                                                    the protection of
                                                    fish, game, and
                                                    wildlife are
                                                    included in this
                                                    industry.
Utility parties (includes       221 Utilities....  Provide electric
 utilities).                                        power, natural gas,
                                                    steam supply, water
                                                    supply, and sewage
                                                    removal through a
                                                    permanent
                                                    infrastructure of
                                                    lines, mains, and
                                                    pipes.
Other Parties.................  713910 Golf        Golf course operators
                                 courses and        who have ponds for
                                 country clubs.     irrigation.
------------------------------------------------------------------------

    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 facility is affected by this action, you should carefully examine 
the applicability criteria in 40 CFR 122.23. If you have questions 
regarding the applicability of this action to a particular entity, 
consult the person listed in the preceding FOR FURTHER INFORMATION 
CONTACT section.

II. Background

A. Clean Water Act and the Federal Insecticide, Fungicide, and 
Rodenticide Act

    Congress passed the Federal Water Pollution 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 prohibits the discharge of any pollutant by 
any person from a point source into a water of the United States, 
except in compliance 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 Pollutant Discharge 
Elimination System (NPDES) permit 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).
    NPDES permits under the CWA are required only for point source 
discharges of materials that are pollutants to waters of the United 
States. Section 502(6) of the CWA defines ``pollutant'' to mean:

    * * * dredged spoil, solid waste, incinerator residue, 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).\1\ 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 Agency ever stated in any 
general policy or guidance that an NPDES permit is required for such 
applications.
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    \1\ The remaining language of the definition of ``pollutant'' in 
Section 502(6) is as follows, and is not relevant to today's action: 
``The term does not mean (A) ``sewage from vessels'' within the 
meaning of Section 312 of this Act; or (B) water, gas, or other 
material which is injected into a well to facilitate 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 resources.''
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    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 labeling directions, pesticides will not pose 
unreasonable risks to human health and the environment. All new 
pesticides must undergo a rigorous registration 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 determining, among

[[Page 68485]]

other things, whether a pesticide ``will perform its intended function 
without unreasonable adverse effects on the environment,'' and whether 
``when used in accordance with widespread and commonly recognized 
practice [the pesticide] will not generally cause unreasonable adverse 
effects on the environment.'' 7 U.S.C. 136a(c)(5). In performing this 
analysis, EPA examines 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 applicant 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 regulated community and other 
affected citizens about 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 
required to obtain an NPDES permit under the circumstances 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 authorities, natural resource managers, 
and others who rely on pesticides regarding their potential obligation 
to obtain an NPDES permit when applying a pesticide consistent with 
FIFRA and particularly about the impact of such a requirement on 
accomplishing their mission of protecting 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 reserved its arguments on that issue in its brief to 
the District Court. Id. at 1184, n.2. The court instead 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, Nevada, Oregon, and 
Washington, all of which are 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 
practice of not issuing permits to people who apply pesticides to 
waters of the United States. These varying practices reflect the 
substantial uncertainty among regulators, the regulated community, and 
the public regarding how the Clean Water Act applies to pesticides that 
have been properly applied and used for their intended purpose.
    The Ninth Circuit recently addressed the Clean Water Act's 
applicability to pesticide applications for a third time. In Fairhurst 
v. Hagener, the court held that pesticides applied directly to a 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 Talent and Forsgren, other courts have addressed the 
applicability of the CWA's NPDES permit requirements to pesticide 
applications. 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 that 
``[u]ntil the EPA articulates a clear interpretation 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 remain open.'' Id. at 67.

B. Interim and Interpretive Statements

    In August 2003, EPA first analyzed the applicability of the NPDES 
permit program to pesticide applications in an administrative context 
through an Interim Statement and Guidance. 68 FR 48385 (Aug. 13, 2003). 
The Interim Statement presented 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 related 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 situations, and did not result from 
deliberative consideration 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 interpretation of the term 
``pollutant'' in the Interim Statement as it relates to certain 
pesticide applications. After considering the public comments, EPA 
issued a final Interpretive Statement on January 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 regulation. The final regulation is 
substantially similar to the proposed regulations, with certain 
modifications described below.\2\
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    \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 return flow is a 
nonpoint source activity not subject to NPDES permit requirements 
under the Clean Water Act. This regulation does not address the 
March 2002 guidance.
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III. Summary of the Final Rule

    EPA is revising the NPDES permit program regulations to add a 
paragraph to the list of discharges 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 relevant 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 applications 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 portion of the pesticides will unavoidably be 
deposited 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

[[Page 68486]]

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 modified the proposed regulatory text only to 
clarify the types of pesticide applications covered in the second 
circumstance (those to control pests present over, including near, 
waters of the United States). Commenters raised concerns that the 
second circumstance, as written in the proposed rule, could be 
interpreted more broadly than the Agency intended (e.g. encompassing 
drift from terrestrial pesticide applications). The final rule 
clarifies that the applications in the second circumstance are those in 
which it is unavoidable that some of the pesticides will be deposited 
into water in order to effectively target the pests. In other words, 
EPA is clarifying in the final rule that the regulation encompasses 
only those applications to control pests over, including near, waters 
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 waters 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 circumstances, it is unavoidable that the 
pesticide enter 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 
generally live over and adjacent to waterbodies. Similarly, 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 Sec.  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 
applications of pesticides to terrestrial agricultural crops.

IV. Discussion

    Today's rulemaking implements EPA's interpretation of the CWA's 
definition of ``pollutant'' with respect to certain applications of 
pesticides. Under the CWA, pollutant means:

    * * * dredged spoil, solid waste, incinerator residue, 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 
conducted in compliance with all relevant requirements of FIFRA. EPA 
considers ``relevant requirements'' of FIFRA to mean those FIFRA 
requirements that relate to water quality. For instance, 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 requirement for purposes of today's regulation. However, 
a labeling provision that governs application rates, active ingredient 
concentrations and dilution requirements, buffer zones, application 
locations, intended targets, times of day, temperature or other 
application requirements, and thus concerns the amounts, 
concentrations, and viability 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 pursuant to FIFRA.
    The application of a pesticide from a point source to waters of the 
United States requires an NPDES permit only if it constitutes the 
discharge 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 circumstances 
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, sewage, garbage, 
sewage sludge, munitions, radioactive materials, heat, wrecked or 
discarded equipment, rock, sand, cellar dirt or industrial, municipal, 
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 applications 
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 process.'' 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.
    EPA also interprets the term ``biological materials'' not to 
include biological pesticides applied consistent with relevant FIFRA 
requirements. This interpretation is both reasonable and consistent 
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 consistent 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 pesticides were to be covered by the Act. The fact that more 
biological pesticides have been developed since passage of the Act in 
1972 does not justify expanding the reach of the NPDES permit 
requirement when there is no evidence that Congress intended the CWA to 
regulate biological pesticides in a manner different from chemical 
pesticides. Finally, biological pesticides in use today are generally 
reduced-risk products that have a narrower range of potential adverse 
environmental 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

[[Page 68487]]

use of biological pesticides by requiring applicators of these products 
to obtain an NPDES permit when chemical pesticides have no such 
requirement.
    In cases in which courts have found specific biological materials 
to be ``pollutants'' under section 502(6) the substances at issue were 
waste materials discharged from a point source. See Concerned Area 
Residents for the Environment v. Southview 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 v. 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 turbine are 
biological materials), U.S. v. Plaza Health Laboratories, Inc., 3 F.3d 
643, 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 intended purpose consistent with applicable EPA requirements was a 
``biological material'' and therefore 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 in 
accord with its finding that ``biological materials'' means the waste 
product of a human or industrial process. The APHETI court based its 
decision that mussel shells, mussel feces, and other materials 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 definition 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 Congress' intent in enacting the CWA and found that the purpose 
of the statute further supported such an interpretation of biological 
materials in that case. Id. at 1016.
    Furthermore, EPA's interpretation that biological and chemical 
pesticides are not pollutants is reasonable because both types of 
pesticides must comply with FIFRA registration requirements. EPA 
reviews and evaluates these pesticides and authorizes their use, 
subject to the limitations and requirements of the EPA registration.
    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 
discharged into a water of the United States from a point source.
    In addition, if there are residual materials resulting from 
pesticides that remain in the water after the application and its 
intended purpose (elimination of targeted pests) have been completed, 
these residual materials are also pollutants under 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 substances that are ``no longer 
useful or required after the completion of a process.'' The New Oxford 
American Dictionary 1905, supra. See also Fairhurst 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 
prohibits 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 material 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 pollutant at the time of the discharge. The 
material added by a pesticide applicator to or over, including near, 
water is not a pollutant for the reasons stated above. Even though the 
pesticide may become a ``pollutant'' at a later time (e.g., after the 
pesticide product has served its intended purpose), a permit is not 
required for its application because it did not meet both statutory 
prerequisites (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 pesticide applications to land. As discussed below, 
EPA has established a multi-stakeholder workgroup 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 today's discussion of the terms 
``chemical waste'' and ``biological materials'' applies only for CWA 
purposes and is not intended to address the use of those terms or 
similar terms under any other statutes the Agency administers.

V. Public Comment

    EPA first solicited comment on its interpretation 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 interpretation when it proposed 
the regulation on which the Agency is today taking final action. See 70 
FR 5093 (Feb. 1, 2005). EPA received many comments on its 
interpretation during both comment periods, from a wide range of 
interested parties including pesticide manufacturers and applicators, 
public health control agencies, State agricultural agencies, State 
environmental agencies, environmental groups, human health advocates, 
farming interests, and other members of the public. Many commenters 
supported EPA's interpretation, while others opposed it as inconsistent 
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 https://www.regulations.gov. EPA is providing a summary 
below of its responses to some of the significant comments received.

A. Scope of Regulation

    Many of the commenters who supported EPA's proposed rule also 
recommended that EPA broaden the scope of the final rule to cover all 
pesticide applications, including agricultural applications over land, 
that are conducted in accordance with the relevant requirements of 
FIFRA. This final rule addresses only the following two circumstances 
described in the proposed rule: The application of

[[Page 68488]]

aquatic pesticides directly to waters 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 permits for agricultural pesticide 
applications that are conducted in compliance with relevant FIFRA 
requirements. EPA is continuing to consider 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 chartered under the Federal 
Advisory Committee Act (FACA)) to address issues involving pesticide 
spray drift from agricultural and other applications. The goals of the 
workgroup are the following: (1) Improving understanding of the 
perspectives of all stakeholders regarding pesticide spray drift; (2) 
finding common ground for further 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.
    The PPDC is a FACA-authorized forum for a diverse group of 
stakeholders to provide feedback to the Agency's pesticide program on 
various pesticide regulatory, policy, and program implementation 
issues. Topics of discussion at past meetings have included the 
disclosure of inert ingredients, registration review, nonanimal 
testing, antimicrobial pesticides, endangered species, reduced risk 
pesticides, labeling, minor uses, ecological standards, fees for 
service, experimental use permits, environmental marketing claims, 
outreach to the public, and several implementation issues emanating 
from the Food Quality Protection Act of 1996.
    Members of the PPDC include representatives of environmental and 
public interest groups, pesticide manufacturers and trade associations, 
user and commodity groups, public health and academic 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 procedural requirements including 
timely public notice of meetings, public access to meetings and 
opportunity for the public to comment; public availability of documents 
considered by the workgroup; and attendance of a federal officer or 
employee at each meeting.

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 pesticides under FIFRA does not adequately protect 
water quality, and thus pesticide applications should require an NPDES 
permit. These commenters alleged both legal and policy shortcomings of 
FIFRA. They also asserted that EPA's interpretation is improper because 
FIFRA does not preempt CWA requirements and because EPA lacks authority 
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 otherwise 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 pollutants from point 
sources to waters of the United States except in compliance with 
section 402 continues to apply. Rather, EPA is exercising its authority 
to interpret a term in a statute it administers. EPA is clarifying that 
pesticides applied to or 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, ``pollutants'' 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 further demonstrate that this is a reasonable 
interpretation, consistent with Congressional intent. EPA's regulatory 
programs under FIFRA provide support for the Agency's conclusion that 
the pesticides applied to or over, including near, water are not wastes 
(and therefore not pollutants) and serve as an indicator of when a 
pesticide is being applied as a product for its intended, beneficial 
purpose. Under FIFRA, EPA receives applications from people who wish to 
sell and distribute pesticides. The Agency may approve and issue a 
registration for a product if EPA determines that the product will not 
cause ``unreasonable adverse effects on the environment,'' which is 
defined as ``any unreasonable risk to man or the environment, 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 environmental benefits that outweigh risks from 
its use. As part of FIFRA registration, EPA may establish requirements, 
which are typically contained 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 of a pesticide in accordance with its approved labeling or other 
relevant FIFRA requirements indicates 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 pesticide regulatory program do not pertain to the legal 
interpretation of whether a pesticide is a ``chemical waste'' or a 
``biological material'' for purposes 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 
account local conditions, existing water quality standards and use 
designations, synergistic effects of multiple pesticides, inert 
ingredients, non-target aquatic organisms, and the effect of multiple 
applicators in the same area. The regulatory and non-regulatory tools 
under FIFRA provide means of addressing water quality problems arising 
from the use of pesticides. In

[[Page 68489]]

particular, the pesticide registration and re-registration processes 
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 pesticide company to submit a substantial 
body of data in support of an application for registration. EPA then 
supplements this required database with information obtained through a 
systematic search of the open literature on the ecotoxicity of 
environmental substances. EPA compares the estimated environmental 
concentrations expected to result from use of a pesticide with toxicity 
values observed 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 degradation products 
and/or metabolites. For additional information on EPA's approach to 
ecological risk assessment in general, and endangered and threatened 
species in particular, see: https://www.epa.gov/espp/consultation/
ecorisk-overview.pdf.

C. EPA's Interpretation of the Term ``Pollutant'' Under the CWA

    Some commenters claimed that EPA's interpretation 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 interpretation of the term ``pollutant'' is 
reasonable and consistent with the language and legislative intent of 
the Clean Water Act. As described above, pesticides applied in the 
circumstances addressed in today'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 circumstances addressed by today's regulation--i.e., application 
to or over waters of the United States consistent with relevant 
requirements of FIFRA. EPA's analysis of the terms ``chemical waste'' 
and ``biological materials'' in the circumstances addressed by today's 
regulation is described in more detail above.
    In addition, the Ninth Circuit Court of Appeals 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 ``chemical waste'' and noted 
that its analysis was in accord with EPA's interpretation of the term 
in its July 2003 Interim Statement, and that EPA's interpretation is 
``reasonable and not in conflict with the expressed intent of 
Congress.'' Id. at 1149-50. Today's regulation is based on the same 
interpretation EPA first articulated in the Interim Statement, and is 
consistent with the Fairhurst court's holding.
    Moreover, EPA's interpretation is not inconsistent with Talent and 
Forsgren as some commenters have asserted. As explained below, these 
cases do not interpret the term ``pollutant'' as including the 
pesticide applications addressed in today'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 vegetation required an NPDES 
permit. The District Court had concluded that the application of the 
pesticide was adequately regulated under 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 application of Magnacide H was a pollutant in this 
case and that registration of the herbicide under FIFRA did not 
preclude applicability of the CWA. Headwaters v. Talent, 243 F.3d at 
532. This conclusion is consistent with EPA's interpretation. As 
described above, EPA agrees that residual materials from pesticide 
applications are ``pollutants'' under the Act. In addition, the 
irrigation 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 
codified 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. Forsgren, the Ninth Circuit 
held that the aerial application 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 Forsgren stated incorrectly that the parties in the case did not 
dispute that the insecticides met the CWA definition of ``pollutant.'' 
League of Wilderness 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 particular issue. Because the Ninth 
Circuit erroneously 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. Id. 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 
different issue from that addressed in today's interpretation.\3\
---------------------------------------------------------------------------

    \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 defining ``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 Statement and Guidance Addressing Effect of Ninth 
Circuit Decision in League of Wilderness Defenders v. Forsgren on 
Application of Pesticides and Fire Retardants,'' Sept. 3, 2003.
---------------------------------------------------------------------------

    Commenters also claimed that EPA's interpretation is inconsistent 
with the Clean Water Act because the purpose for which a pesticide is 
applied is not relevant to the question of whether it is a pollutant 
under the Act. The commenters pointed primarily to two cases--Hudson 
River Fisherman's Assn. v. City of New York, 751 F.Supp. 1088 
(S.D.N.Y.), affd., 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 
distinguishable from EPA's interpretation.
    In Minnehaha Creek, the court was interpreting the terms ``rock, 
sand, [and] cellar dirt'' in the definition of ``pollutant'' in CWA 
Section 502(6). The federal appellants in that case appealed a District 
Court decision finding that the U.S. Army Corps of Engineers did not 
have jurisdiction under CWA Section 404 over the placement of riprap 
and the construction of dams in Minnehaha Creek and adjacent Lake 
Minnetonka. 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

[[Page 68490]]

that a significant alteration in water quality need not be demonstrated 
for a substance to be a pollutant. Minnehaha 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 s[ection] 502(6) 
constitutes the discharge of a `pollutant' under the Act depends upon 
the purpose for which the discharge is made.'' Id. 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 substance is a pollutant depends on the specific 
purpose for which it is discharged. Rather, EPA is interpreting what 
specific terms in section 502(6) mean in the context of certain 
pesticide applications.
    The Second Circuit Court of Appeals decision in Hudson River 
Fishermen's Assn. v. City of New York is also distinguishable from the 
circumstances addressed in today's rule. In that case, the District 
Court held that discharges of chlorine and aluminum sulfate (alum floc) 
from an aqueduct into a reservoir were discharges of pollutants 
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 interpretation, properly 
constituted a pollutant under the statute. Hudson River Fishermen's 
Assn. v. City of New York, 751 F.Supp 1088, 1102. In contrast, today's 
rule addresses certain pesticides which are being applied in compliance 
with relevant FIFRA requirements and, for the reasons described 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 reservoir, not at the time it was first added to the water. The 
court held that the chlorine was a pollutant, 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 substances listed in section 502(6) are pollutants 
depends on the purpose for which they are discharged. Rather, EPA is 
interpreting what specific terms in section 502(6) (terms other than 
those addressed in Minnehaha Creek) mean in the context of these two 
types of pesticide applications.
    Finally, while EPA's interpretation is not inconsistent with either 
Hudson River or Minnehaha Creek, it is further supported by the Ninth 
Circuit's decision in Fairhurst v. Hagener. In Fairhurst, the Ninth 
Circuit specifically considered the purpose for which the pesticide was 
applied--the same factor commenters claim is not relevant under 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. Hagener, 422 F.3d 1146, 1150 
(``Because intentionally applied and properly performing pesticides are 
not `pollutants,' a potential discharger is not required to secure an 
NPDES permit for such pesticides 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 interpretation. 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 consideration 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 
comments. See Memorandum from Ann R. Klee to Benjamin Grumbles and 
Susan Hazen, ``Analysis of Previous Federal Government Statements on 
Application 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 regulatory 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 recommendations 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 Paperwork 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 requirements 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 financial resources 
expended by persons to generate, maintain, retain, or disclose or 
provide information to or for a Federal agency. This includes the time 
needed to review instructions; develop, acquire, install, and utilize 
technology and systems for the purposes of collecting, validating, and 
verifying information, processing and maintaining information, and 
disclosing and providing information; adjust the existing ways to 
comply with any previously applicable instructions and requirements; 
train personnel to be able to respond to a collection of information; 
search data sources; complete and review the collection of information; 
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) generally requires an agency 
to prepare a regulatory flexibility analysis of any rule subject to 
notice and comment rulemaking requirements under the Administrative 
Procedure Act or any other statute unless the agency certifies that the 
rule will not have a significant economic impact on a substantial 
number of small entities. Small entities include small businesses, 
small organizations, and small governmental jurisdictions.
    For purposes of assessing the impacts of today'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 121.201; 
(2) a small governmental jurisdiction that is a government of a city, 
county, town, school district or special district with a population of 
less than 50,000; and (3) a small organization 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

[[Page 68491]]

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, establishes requirements for Federal agencies to assess the 
effects of their regulatory actions on State, local, and tribal 
governments and the private sector. Under section 202 of the UMRA, EPA 
generally 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 governments, in 
the aggregate, or to the private sector, of $100 million or more in any 
one year. Before promulgating an EPA rule for which a written statement 
is needed, section 205 of UMRA 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 alternative if the 
Administrator publishes with the final rule an explanation why that 
alternative was not adopted. Before EPA establishes any regulatory 
requirements 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 timely 
input in the development of EPA regulatory proposals with significant 
Federal intergovernmental mandates, and informing, educating, and 
advising small governments on compliance with the regulatory 
requirements.
    EPA has determined that this rule does not contain a Federal 
mandate that may res