# Pesticides and Ground Water State Management Plan Regulation

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URL: https://www.frixlaw.com/law-library/documents/fr%3A96-16173

## Record

- **Collection:** Federal Register
- **Document type:** Proposed Rule
- **Published:** June 26, 1996
- **Citation:** 61 FR 33260

## Text

SUMMARY: This proposed rule implements a key component of the Agency's
1991 Pesticides and Ground Water Strategy, and reflects many years of
discussions and input from States and other stakeholders. Through the
development and use of State Management Plans (SMPs), EPA is proposing
to restrict the use of certain pesticides by providing States with the
flexibility to protect the ground water in the most appropriate way for
local conditions. This approach capitalizes on the most effective and
efficient roles for State and Federal governments to collaborate in the
protection of the nation's ground water resources. In this proposed
rule, using the proposed SMP approach, EPA is proposing to restrict the
legal sale and use of five pesticides that have been identified as
either ``probable'' or ``possible'' human carcinogens--alachlor,
atrazine, cyanazine, metolachlor, and simazine. Because of their
potential to contaminate ground water, EPA has determined that these
pesticides may cause unreasonable adverse effects on the environment in
the absence of effective management measures provided by an SMP. The
labels of these pesticides would be changed to require use in
accordance with an EPA-approved SMP, after a period allowed for
development and approval of these State plans. Incidentally, this
proposed rule will also revise existing pesticide labeling regulations,
in order to clarify general labeling requirements.

DATES: Written comments must be received on or before October 24, 1996.

ADDRESSES: Submit written comments, bearing the docket control number
``OPP-36190'' by mail to: Public Response and Program Resources Branch,
Field Operations Division (7506C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Comments may be submitted by facsimile to (703) 305-5558. In person,
bring comments to: Rm. 1132, Crystal Mall #2, 1921 Jefferson Davis
Highway, Arlington, VA 22202.
Comments and data may also be submitted electronically by sending
electronic mail (e-mail) to: [email protected]. Electronic
comments must be submitted as an ASCII file avoiding the use of special
characters and any form of encryption. Comments and data will also be
accepted on disks in WordPerfect in 5.1 file format or ASCII file
format. All comments and data in electronic form must be identified by
the docket number ``OPP-36190.'' No Confidential Business Information
(CBI) should be submitted through e-mail. Electronic comments on this
document may be filed online at many Federal Depository Libraries.
Additional information on electronic submissions can be found in Unit
V. of this document.
Information submitted as a comment concerning this document may be
claimed confidential by marking any part or all of that information as
CBI. Information so marked will not be disclosed except in accordance
with procedures set forth in 40 CFR part 2. A copy of the comment that
does not contain CBI must be submitted for inclusion in the public
record. Information not marked confidential may be disclosed publicly
by EPA without prior notice. All written comments will be available for
public inspection in Rm. 1132 at the Virginia address given above from
8 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: Arden Calvert, Policy and Special
Projects Staff (7501C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location and telephone number: Rm. 1113, Crystal Mall #2, 1921
Jefferson Davis Hwy., Arlington, VA, Telephone: (703) 305-7099, Fax:
(703) 305-6244, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: This document is organized into eight units.
Unit I. describes the background and statutory basis for this proposed
regulatory action. Unit II. describes the general considerations by
which the Agency will decide to classify specific pesticides to be
subject to State Management Plans (SMPs). Unit III. describes the
content of SMPs as an ``other regulatory restriction'' pursuant to the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) section
3(d). Unit IV. provides the risk and benefit determinations that are
the basis for today's proposed rule, summarizing data on human health
and environmental risks, ground-water contamination potential and
benefits of the five pesticides subject to today's proposal. Unit V.
provides further information on the public docket established for this
proposed rule. Unit VI. describes referral to the U.S. Department of
Agriculture and the Pesticides Scientific Advisory Panel. Unit VII.
provides a list of references cited in today's proposal. Unit VIII.
provides information on the Regulatory Impact Analysis provided for
this proposed rule and other requirements.

Regulated Entities
------------------------------------------------------------------------
Examples of Regulated
Category Entities
------------------------------------------------------------------------
State Governments States Developing Pesticide
SMPs
Industry Pesticide registrants;
farmers and other commercial
pesticide users
------------------------------------------------------------------------

This table is not exhaustive, but is a guide to the entities EPA
believes would be regulated by this action. Read carefully the contents
of the rule to determine whether this rule applies to you.

I. Basis for Regulatory Action

A. Background

Ground-water resources are of vital importance to the United
States. The quality of these resources affects the health of its
citizens, the integrity of many of its ecosystems, and the vigor of its
economy. Ironically, the variety of human activities made possible by
healthy ecosystems and abundant clean water also threatens the
continued viability of these resources.
Consequently, ground-water protection is a significant
responsibility for EPA. In July 1991, the Agency set forth its ground-
water protection goals and guiding principles in ``Protecting

[[Page 33261]]

the Nation's Ground Water: EPA's Strategy for the 1990's'' (Ref. 11).
The centerpiece of Agency ground-water protection efforts is
development of Comprehensive State Ground Water Protection Programs
(CSGWPPs). These programs are designed to integrate all State and
Federal efforts to protect ground water, increasing the efficiency and
effectiveness of State and Federal resources. The CSGWPPs also mark a
new direction in Federal/State cooperation: EPA supports voluntary
State initiatives to harmonize diverse ground-water protection
activities. Since the use of pesticides contributes significantly to
the problem of ground-water contamination, one of the Agency's first
efforts in developing CSGWPPs is the establishment of State Management
Plans (SMPs) for certain pesticides.
A State Management Plan consists of 12 components that together:
(a) Describe the State's ground-water protection philosophy and
goals, its authority and its organizational and resource basis for
fulfilling its commitment to manage the pesticide's use.
(b) Detail the manner in which the State intends to carry out this
commitment, using such measures as ground-water vulnerability
assessments, ground-water monitoring, and direct management of
pesticide use.
(c) Establish the State's commitments to develop and implement
these provisions through a process of public participation, to make
pesticide users aware of State management measures and to monitor the
effectiveness of the Plan through the development of meaningful
measurements of environmental results.
A pesticide State Management Plan is envisioned to be developed and
implemented in the context of a State's CSGWPP, which outlines the
State's overall ground-water protection approach. The additional
benefits of coordinated implementation of a State's CSGWPP and its SMPs
include: (1) More effective and consistent protection of the resource;
(2) increased State control to target efforts towards highest priority
protection; (3) more efficient use of limited program resources; and
(4) reduced potential for ground-water protection activities to be at
cross-purposes.
While EPA regards the creation of SMPs as a significant step in
protecting ground water from pesticides, EPA will continue to act to
reduce the risk of ground-water contamination in its ongoing national
pesticide registration and reregistration efforts. EPA will continue to
consider specific label provisions for individual pesticide products as
it screens both new and existing uses of pesticides. These may include
general advisory language (warning users of a pesticide's potential to
contaminate ground water and advising caution in the circumstances of
its use) or more specific constraints on the conditions of use, as the
evidence of contamination potential warrants. It may also include
classifying pesticides for use only by or under the supervision of a
certified applicator, under ``conventional'' restricted-use
classification authority (see section D. of this Unit). These
alternative risk-mitigation measures are also part of EPA's
consideration in proposing pesticides for SMPs (see Unit II. of this
preamble).
The concept and development of pesticide SMPs is the direct
outgrowth of extensive, collaborative work to produce a strategy for
achieving ground-water protection by using and integrating all Federal
and State pesticide regulatory authorities and resources. Beginning in
1986, with major public workshops EPA created an interactive process
with other Federal agencies, State agricultural, environment and health
agencies, the private sector, environmentalists, farmers and other
pesticide users, and ground-water experts. The States in particular
have taken an active and constructive role in addressing pesticide and
ground-water issues and have moved ahead with many of the management
approaches ultimately endorsed by the final Agency strategy for
pesticides and ground water.
The Pesticides and Ground-Water Strategy (hereafter referred to as
``the Strategy'') was issued October 31, 1991 (Ref. 12). The Strategy
describes the Agency's goals, policies, management programs, and
regulatory approaches for protecting the nation's ground-water
resources from risks of contamination by pesticides. The Strategy, and
the 1988 proposed Strategy, characterize the breadth and seriousness of
the potential problem of pesticides in ground water and the need for
coordinated regulatory and nonregulatory initiatives to protect the
resource (Ref. 7). Those interested in a more detailed discussion of
the history, purpose, objectives, and policy are referred to the
Strategy itself.

B. Goal

The Strategy articulated the Agency's goal for pesticides and
ground water. In summary, the goal:

is to prevent contamination of ground water resources resulting
from the normal, registered use of pesticides that would cause
unreasonable risks to human health and the environment by taking
appropriate actions where such risks may occur. (Ref. 12, p 9, see
also pp ES 6-7; emphasis added)
This goal highlights two important elements of EPA's pesticide and
ground-water policy: pollution prevention and local action.
Delaying action until ground-water contamination occurs at
significant levels and with a frequency sufficient to cause immediate
concern is costly, and ultimately counterproductive. ``[G]round-water
cleanup is extremely costly, and usually difficult and in some cases
impossible to achieve and demonstrate'' (Ref. 12, p. 10; also, Ref. 11,
p 5). In some cases, actual ground-water contamination may be virtually
irreversible. Allowing contamination to reach a level that presents an
immediate threat to human health or the environment forecloses
prevention and necessitates remediation. Remediation is more costly, as
well as more dangerous, than prudent action to anticipate and prevent
harm.
The second element of the Agency goal is local action. Taking
action locally, ``where such risks may occur,'' takes into account the
highly variable factors affecting the potential for ground-water
contamination. ``Ground water is a uniquely local resource due to the
ease with which small sources can affect it, and the impact that use
and hydrologic characteristics can have on its quality'' (Ref. 11).
There are several factors which generally influence whether
pesticides will contaminate ground water: (1) The properties of the
chemical itself (e.g., solubility in water, persistence, and mobility
in the subsurface environment); (2) the characteristics of the site of
use (e.g., soil type, depth to ground water, temperature, rainfall, and
site-specific hydrological factors collectively denoted by the term,
``sensitivity''); (3) application practices, (e.g., the amount of
pesticide per application, the frequency and method of applications);
and (4) other agronomic practices associated with the pesticide use
(e.g., irrigation or tillage practices).
The Agency believes that, as a general matter, the best method for
addressing differences in sensitivity throughout the country is to
tailor prevention measures in a given area to reflect the vulnerability
of local ground water to contamination. This approach minimizes the
complementary risks of over-regulating where ground water is not
particularly vulnerable to contamination and of underprotecting highly
vulnerable areas which might result from a solely ``national''
regulatory approach. It is expected to

[[Page 33262]]

result in an efficient regulation of pesticide use that will satisfy
the pre-eminent objective of reducing or eliminating unreasonable risk
with respect to ground water.
The Agency has further concluded that for pesticides which may pose
an unreasonable risk, the States can appropriately take the lead in
preventing unreasonable risk and protecting ground water through the
management of pesticide use. State management of use can be based on
local relative vulnerability of the ground-water resource, and where
necessary, its use and value. A lead role for the States, consistent
with overall Agency ground-water protection principles, acknowledges
the traditional primacy of States in the management and protection of
ground water as a natural resource; makes best use of expertise at the
State level in local hydrogeology, soils, agronomic practices, climate,
and pesticide use; and takes advantage of State and local understanding
of population and land use trends that help to define the future use of
ground-water resources.

C. SMP Start-up

State participation in pesticide-use management is a significant
new step for many States, requiring substantial preparation. EPA has
assisted this start-up in several ways, described more fully in the
Strategy.
1. Since 1990, EPA has provided funds to States to help develop
``generic'' SMPs. In these ``generic'' SMPs, States prepare for
development of pesticide-specific requirements by providing basic,
generalized information for each of the required components of a
pesticide-specific SMP. Generic SMPs give States an early opportunity
to consider how they will design Plan components and build the capacity
to implement them. Since Generic Plans have no legal force, EPA does
not ``approve'' them, in the sense of conferring legal authority upon
them; rather, States will submit Generic SMPs for review, comment and
concurrence. Fifty-seven States and territories with primary
enforcement authority for FIFRA use violations, as well as two Indian
tribal authorities, have received funds and are proceeding with
development of the generic SMPs. EPA has provided $35 million in grants
for this purpose in the Fiscal Years 1990 to 1996. By June 1995, all 50
States had developed and submitted draft Generic Plans to EPA regions
for early review and comment.
2. EPA published a Guidance for Pesticides and Ground Water State
Management Plans with two appendices in December 1993 (Ref. 18,
hereafter referred to as the Guidance). It provides practical
instruction on how to develop both Generic and pesticide-specific SMPs.
Much of the contents of the Guidance and the first Appendix anticipates
the contents of today's proposed rule (see Unit II.C. of this
preamble). These documents should be referred to for a more complete
description of how EPA envisions SMPs will be developed, and what EPA
envisions the level of protection will be.
3. As mentioned at the outset of this Unit, pesticide-specific SMPs
are intended to operate as an integral part of CSGWPPs. Likewise,
pesticide and ground-water protection measures tie into other EPA
programs and grants dedicated to ground-water protection. Among the
many related activities are: (a) The non-point source program under
section 319 of the Clean Water Act; (b) Coastal Zone non-point source
measures mandated by the Coastal Zone Management Act as amended in
1990; (c) the emerging ``watershed protection approach'' for
implementing the Agency's Clean Water Act activities; (d) Wellhead
Protection Programs and other drinking-water source-protection
initiatives under the Safe Drinking Water Act (SDWA); and (e) Public
Water System regulatory programs under SDWA, in particular, the
establishment of Maximum Contaminant Levels (MCLs) and monitoring
requirements for a variety of contaminants (including the five
pesticides subject to today's proposed rule). For example, an SMP
designed to deal with pesticide contamination risks could be integrated
with a Well Head Protection Program in a rural community where
pesticide use in nearby agricultural areas posed a threat to well field
re-charge areas. The SMP would provide Federal and State authorities
for pesticide regulation to complement and interact with the State's
other water quality protection authorities to help achieve the goal of
the Well Head Protection Program. A more detailed description of the
variety of interlocking programs is provided in an October 1992
document prepared by EPA's Office of Pesticide Programs (OPP),
``Integrating EPA's Agriculture and Water Grant Programs.''
In addition, the Strategy detailed a variety of related Federal
non-regulatory activities, including U.S. Department of Agriculture
(USDA) research and the ongoing activities of the U.S. Geological
Survey (USGS), as well as the connection between ground-water
protection and the Agency's ongoing pesticide regulatory initiatives,
such as encouraging the development of reduced-risk pesticides.

D. Statutory Authority

As a general matter, pesticides may not be sold, distributed, or
used in the United States unless they are registered by EPA [FIFRA
section 3(a)]. The standard for granting and maintaining a registration
is found in FIFRA section 3(c)(5). Among other things, this section
requires that the pesticide will perform its intended function without
causing unreasonable adverse effects on the environment and that, when
used in accordance with widespread and commonly recognized practice,
will not cause unreasonable effects on the environment.
Further, FIFRA section 3(d) gives EPA authority to classify a
pesticide for restricted use if EPA finds its use may cause
unreasonable adverse effects on the environment. Specifically, FIFRA
section 3 (d)(1)(C) [7 U.S.C. 136a(d)(1)(C)], provides:

If the Administrator determines that the pesticide, when applied
in accordance with its directions for use, warnings and cautions and
for the uses for which it is registered, or for one or more such
uses, or in accordance with widespread and commonly accepted
practice, may generally cause, without additional regulatory
restrictions, unreasonable adverse effects on the environment,
including injury to the applicator, he shall classify the pesticide,
or particular use or uses to which the determination applies, for
restricted use.

In the event the Administrator makes such a determination, ``the
pesticide shall be applied ... only by or under the direct supervision
of a certified applicator, or subject to such other restrictions as the
Administrator may provide by regulation'' (FIFRA section
3(d)(1)(C)(ii); emphasis added). An EPA-approved SMP would be such an
``other restriction.''
The basis for determining whether a pesticide warrants the
``additional regulatory restrictions'' referred to in section
3(d)(1)(C), is finding that the pesticide ``may generally cause ...
unreasonable adverse effects ...'' without such additional
restrictions. FIFRA section 2(bb) defines unreasonable adverse effects
as ``any unreasonable risk to man or the environment, taking into
account the economic, social and environmental costs and benefits of
the use of any pesticide.'' Thus, one of the critical aspects of
determining whether additional regulatory restrictions are necessary is
an evaluation of the risks and benefits of the pesticide use. However,
in finding a pesticide may cause unreasonable adverse effects, EPA will
consider these risks and benefits in a manner that takes into account
the considerable uncertainty surrounding both. Unit IV. of this
preamble, as well

[[Page 33263]]

as the Regulatory Impact Analysis prepared for this proposed rule,
describes the relative risks and benefits associated with the five
pesticides proposed to be subject to SMPs, as well as the costs and
benefits of State Management Plans as a regulatory measure.
Any restrictions imposed under FIFRA section 3(d) authority are
fully enforceable under FIFRA. Section 12 (a)(2) of FIFRA specifically
provides that it shall be unlawful (in subparagraph (F)):

to distribute or sell, or make available for use, or to use, any
registered pesticide classified for restricted use for some or all
purposes other than in accordance with section 3(d) and any
regulations thereunder.

Thus, once this rulemaking is final and EPA has approved the
requirements and specifications that constitute a SMP, that SMP will be
fully enforceable by Federal authorities. EPA will also require
registrants to incorporate the restriction to use a pesticide according
to the provisions of an EPA-approved State Plan as part of that
pesticide's labeling. Thus SMP requirements would also be federally
enforceable pursuant to section 12 (a)(2)(G), which makes it illegal
``to use any registered pesticide in a manner inconsistent with its
labeling.''

II. Process for Selecting Pesticides for Restriction under SMPs

A. Determining Potential to Contaminate Ground Water

As described in Unit I. of this preamble, the Agency's goal for
ground-water protection is to prevent contamination that would cause
unreasonable risks. Prevention entails the need to act in anticipation
of future environmental harm to ensure that this harm does not occur.
There are many uncertainties that limit the ability to quantify
risks and benefits to any reasonable degree of accuracy. These stem in
part from the circumstances pertaining to ground-water risks, and are
discussed further in Unit IV. of this preamble. These and other
impediments to national-level risk-benefit analysis were addressed in
the development of the Strategy, and in fact were instrumental in the
decision to favor the SMP approach in addressing serious pesticide
ground-water risks. Prescribing SMPs for individual pesticides fits
under EPA's regulatory authority to regulate beneficial but potentially
risky substances well before the onset of unreasonable adverse effects.
It also accommodates the uncertainties and variations which
characterize groundwater risk assessment.
This judgement will be made consistent with the Agency's current
regulatory procedures for classifying pesticides for restricted use.
These procedures are contained in 40 CFR part 152, subpart I. They
provide for EPA to impose restrictions other than limiting use to
certified applicators if the Agency determines that:

(a) Without such restrictions, the product when used in
accordance with warnings, cautions and directions for use or in
accordance with widespread and commonly recognized practices of use
may cause unreasonable adverse effects on the environment; and
(b) The decrease in risks as a result of restricted use would
exceed the decrease in benefits as a result of restricted use. (40
CFR 152.171)

Subpart I also provides for restricting use to certified applicators
and for other types of future restrictions, as authorized by FIFRA
section 3(d)(1)(C). Unit III. of this preamble explains in further
detail the distinction between such new ``other regulatory
restrictions'' as this SMP requirement and the conventional restricted
use of application only by or under the supervision of a certified
applicator.
EPA will make such a determination to subject a pesticide to the
requirements of an SMP through a weight of evidence analysis, taking
into account the economic, social and environmental costs and benefits
of the pesticide's use.
The first step in this weight-of-evidence approach is to
characterize a pesticide's potential to contaminate ground water.
Direct evidence of a pesticide's contamination potential includes its
physical-chemical properties (e.g., leaching potential) and the
circumstances, frequency and concentrations of known occurrence in
ground water. In addition to the direct evidence of contamination
potential, EPA will take into account information about use patterns
and practices which may supplement the more direct evidence of
contamination potential. Specifically, EPA will also consider: (a) The
crops and sites on which a pesticide is registered for use; (b) the
volume of pesticide used (on specific sites or crops, or in total) and
the extent of the pesticide's use (in terms of rates and/or number of
acres treated); and (c) the methods, timing, and rates of application
of a pesticide.
EPA will also take into account the potential of any of a
pesticide's by-products, metabolites or degradates, or any other
component of a product associated with the pesticide, to reach ground
water or to cause an adverse effect thereby, to the extent such
substances have been identified and information about their potentials
are known.

B. Determining Potential Risk

The second step is to compare the pesticide's potential to
contaminate ground water to an indicator of unreasonable risk. In
theory, a pesticide may have a ``potential to contaminate ground
water'' but not an associated significant ``potential to cause adverse
effects.'' The Ground-Water Reference Point is an important tool in
determining whether this association exists. Ground-Water Reference
Points are numerical indicators of the toxicity of a substance
established by EPA, based on test data and other reliable health
effects information. The concept of Ground-Water Reference Points was
explicated in the July 1991 Protecting the Nation's Ground Water: EPA's
Strategy for the 1990's (Ref. 11; in Part D, ``Agency Policy on EPA's
Use of Quality Standards in Ground-Water Prevention and Remediation
Activities'') and echoed in the Strategy (Ref. 12). Pursuant to these
policies, EPA will use as reference points for specific substances any
of the following: (1) Maximum Contaminant Levels (MCLs) established
under the Safe Drinking Water Act, or (2) Health Advisories (where MCLs
are not available for a substance), or (3) Water Quality Standards
(where the concern is adverse effects to ecosystems affected by closely
hydrologically linked surface waters) under the Clean Water Act. If
such numbers are not available, reference points may be derived from
the health effects literature where appropriate. In certain cases, the
Agency policy (cited above) provides that Maximum Contaminant Level
Goals (MCLGs) under the Safe Drinking Water Act may be used in order to
comply with Federal statutory requirements; however, MCLGs are unlikely
to be used in the context of any regulatory action the Agency might
take under FIFRA.
In protecting ground water, the Agency takes the reference point as
a benchmark that defines the failure of currently-implemented
preventive measures (c.f., Ref. 11, p. 31: ``Reaching the ...
appropriate reference point would be considered a failure of
prevention.''). In the context of pesticides and ground water, a
detection at or above the level established as the appropriate Ground-
Water Reference Point for a pesticide ingredient would be considered a
failure of measures to prevent unreasonable risk to human health or the
environment associated with that ingredient. Known

[[Page 33264]]

or predicted levels of contamination can be compared to these reference
points in order to gauge the relative risk of adverse effects.
Reference points provide a means by which the Agency may assess and
take into account the toxicity of ground-water contaminants, and
thereby the implicit level of hazard and risk posed by particular
contamination levels. Given the uncertainties regarding: (1) The actual
level and extent of pesticide contamination in ground water; (2) the
nature and degree of human exposure associated with such contamination;
(3) either the levels or the mechanisms of pesticide occurrence that
may affect ecosystems, habitats, or non-target biological organisms;
and (4) the anticipated future levels of occurrence, exposure and
associated hazard, it is problematic to make direct estimates of
exposure, and hence estimates of risk, with satisfactory accuracy.
Therefore, use of reference points to gauge the relative seriousness of
detected pesticide contamination serves as a useful surrogate to direct
estimates of exposure and risk.
It is theoretically possible to determine that a pesticide has the
potential to contaminate ground water, but that it is unlikely to cause
adverse effects. In practice, however, this distinction can often be
difficult to sustain with reasonable certainty. First, there is often
significant uncertainty about the levels and extent of current
contamination. Ground water is not systematically monitored across the
country. Ground waters susceptible to contamination by pesticides vary
significantly in character, limiting the ability to generalize beyond
ground-water monitoring sites. For ground water, models are not
sufficiently reliable to predict future contamination. Second, any
contamination of ground-water resources represents some tangible damage
to its value as a resource to present, and especially future,
generations. The Agency's pollution prevention philosophy clearly
states the Agency's interest in protecting the resource from
impairment. Hence, the Agency included in its Reference Point policy
that, as a matter of policy (Ref. 11):

Detection of a percentage of the reference point at an
appropriate monitoring location would then be used to trigger
consideration of additional action (e.g., additional monitoring,
restricting, limiting use or banning the use of a pesticide).

As a matter of prudence, therefore, the Agency considers the ability to
reach ground water, as indicated by physical and chemical properties,
and detections at any level to be evidence of some potential to reach
ground water at an unacceptable level.

C. Determining Appropriate Regulatory Action

After characterizing the pesticide's ground-water contamination
potential and its associated health and environmental risk, EPA next
considers the adequacy of current labeling safeguards. The Strategy
describes this step (Ref. 12):

If EPA has reasonable assurance from the evidence of a
particular chemical's contamination potential that it would not
cause `unreasonable adverse effects on the environment' if used in
accordance with the requirements of the label or under the
conditions of restricted use [to certified applicators], then
...those national-level management measures [would be] the only
measures necessary.

However, if EPA cannot conclude from the available evidence that
these measures would sufficiently reduce the risk of ground-water
contamination, it could pursue either an approved SMP, ... or
national cancellation if State Management Plans would not be
adequate to prevent risks.

A judgement on the need for State management measures depends on the
Agency's confidence in the effectiveness and efficacy of these uniform
national labeling instructions relative to the protection anticipated
from SMPs, present use practices and patterns, existing State risk-
mitigation measures and other prospective Federal regulatory actions,
including label changes and restricting use to certified applicators.
When EPA has adequate confidence in the efficacy of such measures, it
will conclude SMPs are unnecessary. The decision to prescribe SMPs is a
judgement that national labeling limitations likely will not prevent
the realization of a pesticide's ground-water contamination potential.
In considering whether to prescribe an SMP for a pesticide, EPA
evaluates the benefits of continued pesticide use under the provisions
of an SMP. The assessment of whether the reduced risk of ground-water
contamination might justify the social and economic costs of the SMP is
documented in a Regulatory Impact Assessment. The costs considered
include both the expense of developing and implementing SMPs (e.g.,
direct costs) as well as the costs of foregone benefits (e.g., indirect
costs). Indirect costs may include more expensive pest-control
substitutes and the economic loss associated with less pest control.
The Agency decides to establish the SMP restriction upon a reasoned
determination that the benefits of regulatory action justify its costs,
recognizing that some costs and benefits are difficult to quantify.
Finally, EPA also considers whether it is likely to take other,
more stringent regulatory action such as cancellation of major products
and/or uses of a particular pesticide. For instance, the Agency might
conclude that a pesticide in Special Review poses an unreasonable risk
for reasons different from and in addition to ground-water concerns, so
that only cancellation of major products and/or uses would be
appropriate. In that case, EPA would be inclined not to require the
States to develop SMPs to manage uses that will soon be prohibited. On
the other hand, EPA may both start a Special Review of a pesticide and
propose the same pesticide for SMPs via rule making. There may be a
need to provide the increased level of ground-water protection afforded
by State Plans while the Special Review is conducted. As the Strategy
explained, EPA may also use its cancellation authorities under FIFRA
section 6 to establish SMPs. There are many possible outcomes of a
Special Review besides the more stringent measure of cancellation. For
example, the Agency is addressing the ground-water contamination
potential of the pesticide aldicarb through a Special Review instituted
in 1984, and thus is not including it in this proposed rule. EPA sees
no inconsistency in pursuing both this proposed rule and the new
Special Review for the triazines, initiated in November 1994.

D. Selection of Pesticides for Today's Rule

The Agency has selected five pesticides for regulation under SMPs:
atrazine, simazine, cyanazine, alachlor and metolachlor. In selecting
these five, the Agency evaluated the ground-water contamination
potentials, hazards and uses of 20 currently registered pesticides that
have been reported to occur most frequently in ground water, according
to the available data compiled by EPA's Office of Pesticide Programs
(Ref. 15) (see Table 1). This included the pesticide aldicarb, which
was not considered for this proposed rule in light of its ongoing
Special Review.

Table 1.--Currently-Registered Pesticides Considered for SMPs Because of
Their Detection in Ground Water
------------------------------------------------------------------------
Selected Not selected at this time
------------------------------------------------------------------------
Alachlor Aldicarb
Atrazine Bentazon
Cyanazine Bromacil

[[Page 33265]]

Metolachlor Carbofuran
Simazine DCPA (Dacthal)
Dicamba
Diazinon
Lindane
Picloram
Methomyl
Metribuzin
Oxamyl
Promoton
1,3-D (Telone II)
2,4-D
------------------------------------------------------------------------

The five pesticides selected for this proposed rule, stand apart in
the breadth, frequency, and magnitude of ground-water contamination.
While Unit IV. of this preamble goes into the evidence in greater
detail, each has been detected hundreds of times in many States. Each
has been detected at levels exceeding their corresponding reference
points in multiple locations or times, clearly exhibiting a capacity to
contaminate ground water at concentrations exceeding health-based
standards. All five are also associated with serious and irreversible
toxicological effects, including carcinogenicity. One (alachlor) was
classified as a B2 (probable human) carcinogen by EPA, but is now
considered to be not classified pending further review of scientific
issues; the remaining four have been classified as C (possible human)
carcinogens. These classifications are under review, as discussed later
in this document.
All five are broad-spectrum herbicides with extensive agricultural
uses. These similarities of use suggest that these five can be
regulated together as a cluster. Since all raise significant ground-
water concerns, dealing with them together also helps prevent creating
unintended incentives to substitute ones under State-management
constraints for those less stringently regulated. Analytic methods for
ground-water monitoring of these compounds are available and in
widespread use around the country. This fact, combined with the
commonalities of use practices, will make it easier for States to
develop coordinated monitoring programs for these five as a group.
Among the other candidates, several are known to have occurred in
concentrations exceeding an MCL or Health Advisory Levels, but not as
frequently as the pesticides selected. Furthermore, previous regulatory
restrictions on use can be considered to have significantly reduced the
risks of ground-water contamination for some of these candidates. One
example is carbofuran, which has been detected over 4,100 times from
1980-1990 in 11 States, with 73 of those detections at levels over the
current MCL of 40 micrograms per liter (g/l) (Ref. 15).
However, the vast preponderance of those detections (and all but one of
those above the MCL) occurred in Suffolk County, New York, where all
carbofuran use was banned in 1987. In addition, granular carbofuran
products (which represent most of the chemical's prior use) have been
phased out except for a few specialty uses. Other candidates on the
list have had frequent occurrence in ground water, but neither as
widely nor as frequently at high concentrations, as the five selected
for this proposed rule.
EPA is proposing in today's rule to regulate those pesticides which
in its judgement pose the greatest threat to ground water. The number
of chemicals involved - five is a manageable number to ask States to
manage; EPA hopes to facilitate State participation by designating only
a manageable number of pesticides for SMPs at the outset.

III. State Management Plan Specifications, Development and Approval
Procedure

A. Introduction

This document proposes adding a new subpart J to 40 CFR part 152,
specifying SMPs as an ``other regulatory restriction'' authorized by
FIFRA section 3(d).
Much of what SMPs will be and how they will work has been discussed
in previous documents (e.g., the Strategy). In particular, this Unit of
today's proposal follows closely the contents of EPA's Guidance (Ref.
18). The Guidance (with two Appendices) describes in detail EPA's
expectations about the contents of an acceptable SMP, as well as the
criteria and procedures EPA Regional Offices will use in deciding
whether to accept or reject State Plans. Readers seeking more details
on these subjects should refer to the Guidance. EPA intends generally
to use the Guidance in reviewing State submissions, and to follow the
provisions of the Guidance's Appendix A in review, approval,
evaluation, amendment and (where necessary) revocation of State
Management Plans. However, the Guidance is subject to revision; for
example, the Agency fully expects to supplement the existing guidance
in light of comments on today's proposed rule.
As explained in Unit I. of this preamble, State Management Plans
are intended to complement CSGWPPs; as such, SMPs can be regarded as a
program-specific subset of a CSGWPP. However, the requirements proposed
here are specific to pesticide regulation under FIFRA, and so are
somewhat more detailed than what is required under a completed CSGWPP
as described in the 1992 Guidance. For example, under the Prevention
component of SMPs (c.f., section 2(g) of this Unit, below), specific
best management practices need to be listed and described for each
pesticide. To meet SMP requirements efficiently, a State can
extensively refer to portions of its CSGWPP, but the State also will
need to build on the basic policies and approaches of the Comprehensive
Program. Similarly, in the development of its CSGWPP, a State should
ensure that aspects relevant to pesticides management are consistent
with the requirements of an SMP. Because development of SMPs and
CSGWPPs will occur at the same time in most States, the development of
SMPs should not wait until a CSGWPP is completed. The Guidance on
Pesticides and Ground Water State Management Plans describes the
interrelationships of SMPs and CSGWPPs in greater detail (Ref. 18).
Several definitions of terms, applicable to this new subpart J, are
proposed, in the new 40 CFR 152.183. The term ``ground water reference
point'' (as discussed in Unit II.B. of this preamble) is defined for
purposes of specifying the contents of an approveable SMP, and is
consistent with the Agency's reference point policy. Two other terms
are defined simply to facilitate reference to frequently referred
concepts. The term ``Plan'' is defined as a shorthand term to refer to
the SMP which is the subject of subpart J. In addition, ``State''
itself is defined to mean not only the 50 States, but also Puerto Rico,
the District of Columbia, Guam and other territories and jurisdictions,
plus Indian lands. This last category will be discussed in more detail
below.
The proposed restriction itself is relatively simple and
straightforward: a pesticide or pesticide product that is classified in
this or a subsequent rulemaking may only be used in accordance with the
provisions and requirements of an Agency-approved SMP, as of a specific
date to be established by the rule. At that time, that pesticide or
pesticide product may not be sold or used within a State without an
Agency-approved Plan. These restrictions are the meaning of references
to a pesticide being ``under,''

[[Page 33266]]

``subject to,'' ``classified for,'' ``designated for,'' or ``listed
for'' SMPs.
The proposed ``restriction'' section (40 CFR 152.185) also contains
some requirements on the registrants to amend the labeling of the
products subject to SMPs, in order to notify users that use is now
subject to the conditions of an approved SMP. Labeling provisions will
be discussed in more detail in Unit III.G. of this preamble. Since the
direct effect of this rule would be to limit the sale and use of the
pesticide to States with approved SMPs, it would affect distribution
and sale of these pesticides. Thus, distribution and sale of the
pesticides subject to this rule with improper or obsolete labeling will
be prohibited after the effective date of the rule.
The ``restriction'' will entail a specific label statement, as
follows:

For use only in accordance with an EPA-approved State Management
Plan (SMP) for ground-water protection. Sale and use are prohibited
in States that do not have an EPA-approved State Management Plan.

This restriction would be effective 33 months after promulgation of
this proposed rule as final. This period is designed to allow States to
develop the Plans, EPA to review them, and registrants to change
labels. Comments on the proper time frame for the effective date of
SMPs are welcome; the Agency would especially value specific
explanations of any procedural or legal constraints that States face in
developing SMPs.
This restriction is a classification for restricted use pursuant to
FIFRA section 3(d), but the classification does not automatically
entail the restriction of use ``only by or under the supervision of a
certified applicator.'' Conventionally, ``restricted use'' has come to
mean exclusively this restriction to use by certified applicators, as
specified in the Act. This disregards the possibility of more flexible
meanings for ``other regulatory restrictions.'' Nonetheless, three of
the five pesticides being proposed for SMPs today are already
classified for restricted use in the conventional sense (one of which,
atrazine, is explicitly classified for ground-water contamination
concerns). Moreover, all five meet EPA's proposed criteria for
considering a pesticide for restricted use classification because of
ground-water concerns, as proposed May 13, 1991 (56 FR 22076).
Therefore, EPA is interested in receiving comment on whether the Agency
should simultaneously classify all of these pesticides for
``conventional'' restricted use due to ground-water concerns when it
determines that they require an SMP. Such a procedure would oblige EPA
to make a finding that the pesticide in question meets the criteria of
40 CFR 152.170, but such a finding could be made in this rulemaking for
SMPs, since the Agency has laid out in this proposed rule an analysis
of risks and benefits for these pesticides that could justify such a
determination. EPA believes that such findings would be facilitated by
the establishment of final ground-water restricted-use criteria.
The provisions, specifications, and requirements of these EPA-
required State Plans do not replace, but add to existing or future
national-level conditions of use, such as label directions for use,
restrictions or precautions. Unless specifically provided, either in a
final rule or in some action to amend a product's label, nothing in an
SMP will supersede a national-level condition of registration. States
may not supplant, override, or nullify a Federal label provision in
developing an SMP proposal, or in implementing an EPA-approved SMP.

B. Overview of Application Approval Process

Section 152.187 of the proposed new subpart J sets out the
procedures by which a State may submit, and EPA would approve, an SMP
for each of the five pesticides covered in today's proposed rule.
1. State submissions. While Sec. 152.187 provides that a State may
submit a proposed Plan at any time, Sec. 152.187 prohibits use of a
pesticide or pesticides in question in States without an EPA-approved
Plan after the effective date for the regulation. For practical
purposes, then, a State would need an approved SMP in place by the date
33 months after the promulgation of the final rule, the proposed
effective date of this regulation, in order that sale and use of the
pesticide(s) in question continue within the State's borders.
States that intend to develop SMPs for any or all of the five
pesticides in today's proposed rule will be required to submit proposed
Plans for official EPA review within 2 years of the promulgation date.
This would allow 9 months for EPA to review, consult and decide on
approval of the State's submittal, and for States to prepare the
implementation of the approved SMP on the effective date of the Federal
restriction. States submitting Plans later than 2 years after
promulgation of the rule would run a substantial risk that EPA will be
unable to perform its review, and approve the Plan before the effective
date of the regulation to enable the States to implement it at that
time. As noted above, EPA welcomes comments on the feasibility of this
proposed schedule.
In the interest of encouraging use of electronic information
technology, EPA is proposing to require States submit their SMPs
electronically (e.g., by disk) in an appropriate word processing
format.
EPA would encourage States to submit SMPs for these five pesticides
together, as a single package. While the SMP requirement imposed by
this proposed regulation would be a condition of registration for each
pesticide individually, EPA believes it is proper for States to combine
their SMP submittals, at least for the five pesticides subject to this
proposed rule. Combined submittals should be a resource savings for
both EPA and the States, since these five pesticides are similar in use
patterns and analytic methodologies. For practical purposes, large
portions of Plans for individual pesticides can be expected to be
substantially identical to each other (e.g., vulnerability assessments,
monitoring sites), beyond the shared ``generic'' elements like
philosophy and goals, legal authority, and resources. EPA would
evaluate the adequacy of such joint SMPs together, as a cohesive multi-
chemical Plan. However, EPA would retain the ability to selectively
approve or disapprove Plans for individual pesticides covered by such a
multi-chemical Plan, based on a judgement that the combined Plan is
inadequate in some respect.
2. EPA review, approval, or disapproval. EPA intends to be flexible
in its review of SMPs, recognizing that different approaches and
philosophies can obtain the same environmental results. States will
need to tailor prevention measures to local ground-water vulnerability,
current and future use and value of ground water, pesticide use and
agronomic characteristics and institutional characteristics. Appendix A
of the Guidance describes in greater detail the internal process,
including the general roles and responsibilities of EPA Headquarters
and Regional Offices.
While the regulation specifies that ``the Administrator'' will make
the determination whether a State submission is acceptable, it is the
Agency's intention to delegate this authority to the Regional
Administrator when the regulation is promulgated. The proposal as
drafted requires States to submit their Plans to the appropriate EPA
regional office. As the Guidance (Appendix A, p. 2-1) makes clear, EPA
believes the Regional Administrator is the proper official to make this
determination, given the proximity to the States and their particular

[[Page 33267]]

circumstances. In delegating approval authority to the Regional
Administrator, EPA anticipates that only a limited Agency Headquarters
role will be necessary. Headquarters will help assure overall national
consistency among Regions by providing a forum to, for example, air
issues which Regions believe may need additional clarification. It is
EPA's assumption that such consultation will be particularly helpful in
the beginning of SMP development and implementation; therefore, the
Agency has established a regular schedule of regional/HQ consultation
to facilitate regional review of initial Generic and pesticide-specific
SMPs. After promulgation of the rule, Headquarters will continue to
provide specific national policy guidance and technical assistance as
the regions require.
The Guidance, in Appendix A (Chapters 2-4), envisions a two-step
process for EPA review and approval or disapproval of proposed State
Plans. The first step, a completeness review, is to ensure that the
State has addressed all 12 components of an SMP, pursuant to the
requirements set forth in Sec. 152.190 of the proposed new subpart J.
The second step, content review, is a more thorough examination of the
SMP to determine whether it adequately addresses each of the 12
components of an SMP and therefore is likely to protect the ground-
water resource from pesticide contamination.
As expressed in Appendix A of the Guidance, EPA expects that during
the review and approval process there will be close and frequent
interaction between the regions and the States to reach a mutually
acceptable final Plan.
However, Sec. 152.187(d) of the proposed rule does provide for the
possibility of EPA disapproval of a State-submitted Plan. In content
this section parallels the procedure EPA is proposing to revoke
previously-approved SMPs (see Sec. 152.195, discussed in F., below and
Appendix A).
If the Regional review concludes that the State Plan is inadequate,
either in completeness or in content, the Regional Lead Office would
work with the State to address concerns before the effective date of
the SMP restriction to prevent interruption of sale and use of the
subject pesticide in the State. If the State fails to satisfy the
Agency's concerns, the sale and use of the pesticide would be
prohibited in the absence of EPA approval.
In the event the Region and State fail to reach agreement on an
SMP, the Regional Administrator will notify the State Liaison and the
officials directing the key State agencies in writing, indicating that
EPA will not approve the State's Plan in its present form. This letter
of notification will provide the State a last opportunity to satisfy
the Regional Administrator's concerns and/or persuade the Regional
Administrator that the State's proposal is adequate.
Even formal disapproval would not represent the end of a State's
opportunity to develop a Plan. Since proposed Sec. 152.187 provides
that States may submit an SMP for regional consideration ``at any
time,'' a State whose Plan or Plans have been disapproved would be free
to revise and re-submit the Plan at its discretion.
Whether the Regional Administrator approves or disapproves a
State's Plan, he or she will publish a formal notice of the decision in
the Federal Register. As proposed, notice of the final decision to
approve or disapprove is the only formal notice provided for by this
regulation. In proposing this rule, EPA considered, but decided
against, providing for formal public notice and opportunity for comment
on the Regional Administrator's review of each State Plan. In making
this decision, EPA in part relies on the requirement that the States
must provide for public participation in SMP development to obtain EPA
approval of such a Plan (see proposed Sec. 152.190(j) of the regulatory
text).
With this proposal, therefore, EPA states its belief that there is
sufficient evidence of unreasonable adverse effects on the environment,
within the meaning of FIFRA section 3(d)(1)(C)(ii), to warrant adoption
of SMP's as an additional regulatory restriction. The Agency's basis
for this proposed determination is set out in Unit IV. of this
preamble.
Today's proposal, if finalized, would establish that there may be
unreasonable adverse effects without the additional regulatory
restriction of an SMP. The question then remains as to whether the
particular Plan is adequate to prevent unreasonable adverse effects on
the environment, or whether it is overly restrictive, i.e. whether a
particular SMP adequately takes into account the social and
environmental costs and benefits of the use of the pesticide. The State
would consequently be able to develop and justify its SMP pursuant to
the unreasonable adverse effects standard, as well as against the
specific programmatic elements set out in this proposed rule.
EPA is also proposing procedures to assure adequate notice and
opportunity to comment on whether a particular SMP satisfies the
unreasonable adverse effects standard and the specific programmatic
elements. Thus, States would be required to provide notice and
opportunity to comment on these issues as part of its SMP
implementation procedures. The State would have to respond to any
comments and to justify its chosen approach in the administrative
record developed to support the SMP. In deciding whether to approve or
disapprove the SMP, EPA makes its final determination that unreasonable
adverse effects may be present without additional State measures,
relying on the record developed by the State during the SMP process, as
well as on the record of this initial rulemaking establishing the SMP
restriction.
3. Indian lands. It is EPA's intent in proposing this rule that no
geographic area be excluded from coverage by an EPA-approved SMP upon
the effective date of the regulation. To this end, Indian Tribal
authorities will have the opportunity to develop Tribal SMPs in the
event they wish to allow sale and use of these five pesticides on
Indian lands under their jurisdiction. A few Indian lands have already
received Federal financial assistance through FIFRA program grants to
develop Generic SMPs. Indian tribes preparing SMPs would be subject to
the same procedures and requirements that are described here for
States.
However, Indian tribal authorities will not be required to develop
Plans if they have no interest in allowing sale and use of the five
pesticides within their jurisdiction. Furthermore, Indian tribal
authorities that are interested in preserving sale and use of any of
these five pesticides within their jurisdictions, but believe they are
not able to commit the resources required to develop or implement a
Plan, might be able to reach an agreement with an adjoining State
authority to extend coverage of the State Plan to the Tribal lands.
Such an agreement would have to be submitted to the pertinent EPA
Regional Office for review.

C. Plan Requirements

An EPA-approved SMP will consist of 12 specific components, each
developed in sufficient detail and scope to demonstrate the adequacy of
the Plan. ``Adequacy,'' as generally used here and in the regulatory
text, means that the content of, or commitment contained in, each
component demonstrates that the general objective in establishing an
SMP is met: preventing ground-water contamination by the pesticide or
pesticides subject to this proposed rule, that may present adverse
effects to human health and the environment. This entails an evaluation
of the

[[Page 33268]]

adequacy of the State's proposal. A State's submission will not be
satisfactory if it only provides a ``description'' of a provision,
without regard to whether the provision represents adequate groundwater
protection. Provisions cannot be merely ``adequately'' described; they
must provide for successful implementation of ground-water protection.
A Regional Administrator could disapprove a Plan on the basis of
finding one or more of the components submitted will not fulfill the
general objective for which EPA decided to make the pesticide subject
to SMPs in the first place: the provision of State management measures
that will prevent unreasonable adverse effects and protect the
environmental integrity of the State's ground water.
Each State Plan, for each pesticide proposed for SMPs, must address
each of the 12 components. These components are being proposed under
the new 40 CFR 152.190. The proposed requirement that an acceptable SMP
contain 12 components still gives a State a large degree of flexibility
in managing the use of the pesticides subject to SMPs. While all 12 of
these components will need to be discussed in an SMP, States will be
allowed a substantial range of flexibility in the form and manner by
which they propose to perform the functions contained in each
component. This variability will reflect differences in State ground-
water protection philosophies and regulatory approaches. Further, the
Agency anticipates that the contents of State Plans will vary in
extensiveness and detail according to the potential magnitude of the
ground-water contamination threat. The Agency expects that in low-risk
circumstances (e.g., a State in which a subject pesticide is not
currently used, or in which use is limited to areas with a minimal risk
of contamination), an acceptable SMP may need to be little more than an
augmentation to a ``Generic'' SMP, showing how the State would move to
a greater level of effort in the event the original low-risk
circumstances change, or new evidence warrants. The Agency does not
intend that a State will necessarily impose regulatory restrictions on
every area of use or specific crop use pattern within a State involving
a subject pesticide; if there is an appropriate basis for determining
that an area or use site does not pose a significant risk of ground
water contamination, the State's SMP might not require any change in
user practices from the current Federal label. However, a State
proposing such a position in its SMP would have to provide a reasoned
basis for its conclusion that the risk of ground-water contamination
for a particular geographic area or use site is such that further
restriction is not required. EPA is prepared to accept this manner of
variation among State plans; indeed, the need for this flexibility is
the foundation of the entire SMP approach.
As a general matter, EPA Regional Administrators will evaluate each
component individually and as each complements the other components. In
many cases, the adequacy of a particular component's contents will
depend in a material way on the contents of another component. Again,
this approach is expected to give States a great deal of flexibility. A
good example of this is the interrelationship between the
``monitoring,'' ``assessment,'' ``prevention'' and ``response''
components. States may differ in judging the relative efficacy of
assessment methods for estimating the sensitivity of aquifers to
contamination, versus ground-water monitoring. As a result, one State
could put little emphasis on the assessment efforts, but compensate by
placing a more substantial emphasis on monitoring. Another State could
choose the opposite. Either approach could very well prove to be
adequate. Still another State might view relying on either or both as
deficient, and choose to emphasize prevention by imposing more
stringent use-management measures more routinely. However, a State Plan
that committed to a minimal effort in all three spheres could well be
found to be inadequate. These interrelationships are discussed in more
detail under the specific component headings in the Guidance. Thus,
each Regional Administrator will be evaluating each component on its
own merits, but also how all of the individual components work together
to fulfill the ultimate objective of protecting ground water.
Furthermore, the Agency recognizes that certain elements of SMPs,
particularly the vulnerability assessment and monitoring components
(described below), entail extensive technical activities and
substantial long-term resource commitments. One purpose in promoting
the development of ``Generic'' SMPs is to provide for a head start in
developing such technical capacity. However, the Agency does not expect
that an acceptable SMP must in every instance have such components
fully developed and in place at the time the State Plan is approved.
Rather, an acceptable SMP may be at times one that provides an
adequate, credible commitment and action plan to phase in such
components in order to meet the State's ground-water protection goal
specified in their SMP. Failure by the State to meet the commitments
made in the SMP would result in EPA reconsidering the original decision
to approve the SMP.
The Guidance, in chapter 3, describes EPA's expectations as to what
an adequate State submission will entail. As a general rule, EPA will
apply the criteria set forth in the Guidance in determining the
adequacy of individual State plans. Obviously, guidance criteria are
not intended to be as rigid as requirements established in regulations.
However, a Plan is more likely to be acceptable if it conforms as much
as possible to the provisions of chapter 3 of the Guidance. A State
submission that fails to meet these criteria risks disapproval.
The Agency notes that, since State Management Plans are a new and
evolving regulatory mechanism, the guidance for implementing Plans will
also evolve. Thus, the Agency is likely to issue further clarifications
to the Guidance as issues are raised by Regional Offices and States.
For example, the comments that EPA receives in response to this
proposed rule may be an important source for identifying such issues.
The following sections briefly describe each of the 12 mandatory
components of an adequate State Management Plan being proposed in
Sec. 152.190.
1. State's philosophy and goals toward protecting ground water.
Proposed Sec. 152.190(a) would require that a Plan describe the State's
philosophy and goals for protecting ground water. An acceptable plan
must demonstrate that the State's goals and objectives are no less
protective than EPA's goal of preventing unreasonable adverse effects
to human health and the environment and to protect the environmental
integrity of the nation's ground-water resources.
EPA's strategic approach emphasizes the prevention of contamination
over remedial treatment. Further, it focuses priorities on sources of
drinking water currently used, or reasonably expected to be, and ground
water that is closely hydrologically connected to surface waters. While
a State's goal must be no less protective than the Agency's, States
will be free under the regulation as proposed to articulate its ground-
water protection philosophy and goals in alternative form and language.
In any case, a State submission, to be judged adequate, must include a
statement that addresses both the ground waters to be

[[Page 33269]]

protected and the degree of protection to be achieved under the SMP.
2. Roles and responsibilities of State Agencies. State efforts to
implement the Strategy will, out of necessity, require extensive
coordination among State health, environment, agriculture, and water
agencies. The SMP must include a description of the roles and
responsibilities and coordination mechanisms of involved State
agencies. For an SMP to be found adequate by EPA, it must satisfy six
general provisions set forth in proposed Sec. 152.190(b). For a further
description of what these provisions entail, refer to pages 3-4 and 3-5
of the Guidance.
3. Legal authority. A State's ability to carry out prevention and
response actions for pesticides in ground water is dependent on its
legal authority to regulate pesticide use and protect ground water, to
be provided pursuant to the provisions of proposed Sec. 152.190(c).
Regulatory authorities must be sufficient to accomplish the desired
outcomes of the SMP. EPA will consider this component in parallel with
the provisions of proposed Sec. 152.190(i) on enforcement mechanisms.
Descriptions of enforcement authorities provided in this component
should be cross-referenced to that component as well. One suggestion is
that the State provide a graphic ``crosswalk'' of legal, regulatory and
enforcement authorities (e.g., a side-by-side comparison of SMP
requirements as described in proposed Sec. 152.190, and corresponding
State authorities for implementing each requirement, modelled after
what is currently provided for in the Public Water System program [40
CFR part 142.12(c)].
Under Sec. 152.190(c), a State's plan must identify the specific
legal authorities to be used in implementing the plan, to ensure that
the State's submission is legally enforceable. Presently there is no
provision that the State's chief legal officer be required to examine
the submission, and be satisfied that the appropriate provisions of the
plan are legally enforceable under State law. Several other EPA
programs require a certification from the State Attorney General (or a
designee) to ensure that there is sufficient legal authority to enforce
provisions of the program. This approach provides further assurance
that all of a State's rulemaking procedures have been followed, and
that, as a result, the SMP is enforceable under State law. Such a step
should reduce the likelihood that a legal challenge to the rule will
not be sustained, and should entail a small resource requirement on the
State. EPA is soliciting comment on whether the Agency should also
require in the final rule that the State's submittal include such a
certification.
4. Resources. A State's ability to carry out the commitments
delineated in its SMP depends on the resources available to implement
the program. Resources include technical expertise and personnel,
physical and operational capabilities, and funding. Proposed
Sec. 152.190(d) requires that the SMP demonstrate that the necessary
expertise is available and that there is an adequate match between
revenues and proposed expenditures. This demonstration must:
i. Indicate what categories of personnel or technical expertise are
necessary and available for implementation of the Plan.
ii. Include an estimate of the costs, both physical and
operational, to develop and implement each element of the Plan.
iii. Disclose the current funding available for implementation of
the program, existing and potential funding sources for the future, and
a commitment to pursue additional funding if needed.
EPA will only be evaluating the adequacy of the resources specified
in determining the adequacy of the overall Plan, and will not be
judging the manner in which the State provides for those resources.
However, EPA strongly encourages States to develop innovative means to
finance and implement SMPs, such as user and/or sales fees, in order to
reduce the burden on a State's general revenues. EPA will also explore
ways of helping to shift some of the financial burden of implementing
SMPs from the States to registrants, for example, in providing for
concurrent National ground-water monitoring requirements.
5. Basis for assessment and planning. One of the fundamental
principles in the Strategy is the tailoring of protection activities to
the unique hydrogeologic settings, pesticide usage patterns, and
agronomic practices of each State. The effectiveness of protection
activities depends to a large extent on the degree to which vulnerable
areas in need of protection can be accurately identified. Therefore,
States must have an ongoing program that provides basic information on
the occurrence, movement, and quality of ground water in relation to
patterns of pesticide use. State Agencies of environment, water,
agriculture, and health must all have the opportunity for input into
this program. Pages 3-7 and 3-8 of the Guidance (supplemented by
chapter 3 of the Guidance's Appendix B) describe in further detail the
function and activities embodied by the term, ``assessment and
planning.''
The component prescribed by the proposed Sec. 152.190(e) is, for
practical purposes, a description of the process by which a State will
set priorities for prevention and response actions. In this component,
the State will describe how it will assess ground-water vulnerability,
use and value and how that assessment will be used: (a) To set
priorities for protection activities; (b) to design and implement
prevention and response measures; and (c) to determine the
effectiveness of these measures and of the implementation of the
overall Plan. An adequate SMP for these five pesticides must include a
description of how the State will address vulnerability assessment on a
sub-county level for the geographic area in which the State intends to
allow continued use of the pesticides. EPA considers this level of
geographic detail necessary in ground-water vulnerability assessment
because it is generally held that current methods of vulnerability
assessment are generally not capable of predicting the vulnerability of
broader geographic areas, such as counties. It is widely held that the
hydrogeologic factors which influence the sensitivity of particular
ground waters vary within areas smaller than typical American counties.
Distinguishing areas of different ground-water sensitivity must involve
``sub-county'' geographic units (see the Guidance and its Appendix B
for further discussion of the basis for these opinions). It is also
generally accepted that such assessments will entail a substantial
level of effort. There is no standard definition of what the size or
dimensions of a ``sub-county'' unit might be, other than the general
observation that it is an area that is relatively homogenous with
respect to the hydrogeologic characteristics that influence ground-
water sensitivity.
While an adequate SMP must discuss what the State's approach to
vulnerability assessment at the sub-county level will be, it must also
discuss the limitations of its assessment techniques and how these
limitations are taken into account in the design of prevention and
response programs (see g. and h., below). For example, a State could
describe in its submission for this component that it does not or
cannot currently perform adequate vulnerability assessments to the
desired level of detail, but then explain how the State will impose
more restrictive pesticide use practices across a wider geographic area
(e.g., an entire county where a pesticide might be used) so as to
protect the most vulnerable ground waters within that area. In other
words, if a State applies prevention measures

[[Page 33270]]

on broad regional or county-level designations, then sub-county level
assessments may not be needed. However, the State should explain why
the measures chosen are likely to be adequate to meet program goals.
Conversely, if a State plan allows sub-county or farm-level
distinctions in applying prevention measures, it should explain the
basis for making such distinctions, and how protection goals will be
met. EPA's expectations as to the adequacy of this component are
further discussed in pages 3-8 through 3-10 of the Guidance.
6. Monitoring. Broadly defined, ``ground-water monitoring'' is the
set of activities that provides chemical, physical, geological,
biological, and other environmental data needed by environmental
managers/decision-makers to assist in developing and implementing
ground-water protection policies and programs. Ground-water monitoring
is viewed as a continuum of activities ranging from defining background
conditions, to defining the existence and extent of contamination, to
defining the success of prevention and response measures and programs
to protect the ground-water resource. The Guidance (in pages 3-10 to 3-
11 and in Chapter 5 of Appendix B) discusses in further detail the
dimensions of ground-water monitoring activities and their various
functions in programs aimed at preventing pesticidal contamination of
ground water.
An adequate SMP must describe the State's monitoring program for
pesticides, the uses to which monitoring will be applied, and the
parties responsible for various functions associated with monitoring. A
current, approved State Quality Assurance Project Plan (QAPP), as
described in chapter 5.4.2 of the Guidance's Appendix B, is a
prerequisite for approval of an SMP. The provisions of such a plan will
apply to data collected by the State as well as to any data collected
by some other party on behalf of the State, for the purposes of
performing the State's monitoring component. Such a quality assurance
plan will provide sufficient assurance of the integrity of the data so
as to preclude the applicability of the Agency's Good Laboratory
Practices (GLP) regulations (40 CFR part 160). However, certain
conceivable data collection activities (e.g., monitoring studies
required by EPA as an adjunct to State monitoring, described in the
next paragraph) could be subject to GLP Standards. The distinction
would lie in: (1) Whether the monitoring activity is described in,
referred to, or otherwise pursuant to, the monitoring component of the
approved SMP; and (2) whether the monitoring activity directly relates
to the maintenance of the Federal registration of the pesticide. For
example, monitoring activities performed by a third party (e.g., a
university) under the authority of the State's monitoring plan would be
subject to QAPP provisions. Registrant monitoring directed by the State
would similarly be subject to the State's QAPP. However, registrant
monitoring performed either at EPA's behest or performed on the
registrant's own initiative (but without State mandate or not at the
State's behest) would be subject to EPA's GLP standards.
The essential criteria to determine the adequacy of the monitoring
component of a State Plan are whether the State's monitoring effort is
appropriate to achieve the purposes of the Plan, and whether the level,
quality and extent of specific monitoring efforts provide a reasonable
likelihood that contamination representing an unreasonable risk to the
environment will not go undetected. As discussed earlier, the judgement
of the adequacy of a monitoring component must be made in consideration
of the stated goal of the Plan, and the contents and design of its
constituent assessment and protection components. Further discussion of
EPA's expectation of what constitutes an adequate monitoring component
can be found in the Guidance (pages 3-11 through 3-13).
EPA assumes that monitoring activities will represent a significant
portion of a State's resource investment in implementing its SMPs.
Based on past State experience, EPA estimates in its Regulatory Impact
Analysis for this proposed rule (see Unit V. of this preamble) that
ground-water monitoring activities by themselves may constitute between
10 to 14 percent of the annualized State program costs. Furthermore,
the costs of performing ground-water monitoring can be expected to vary
widely across the country, inasmuch as the States are starting from
different points in the degree of current monitoring. To help alleviate
this resource requirement on the States, EPA is considering development
of national-level requirements (pursuant to its data-call-in
authorities under FIFRA section 3(c)(2)(B)) for additional ground-water
monitoring from the registrants of these five pesticides. Such
concurrent data-gathering requirements would be developed with
reference to submitted State Plans, so that the ultimate requirement on
the registrants would not be unduly burdensome and would be tailored to
the strengths and weaknesses of actual SMPs. Such a requirement would
also be designed to provide States the opportunity to review and
comment on Federal specifications to the registrants, to ensure harmony
with State intentions.
7. Prevention actions. The emphasis of EPA's Pesticides and Ground-
Water Strategy is on prevention, and the core of an acceptable SMP will
be its program of managing particular pesticide use in order to prevent
contamination. Preventive management approaches may vary based on
ground-water vulnerability and ground-water use and value, as well as
social and economic factors. The actual measures employed may range
from education of users, voluntary or mandatory best management
practices, such as changes in application rates, methods and timing,
all the way to use prohibitions in specific areas. As noted above, the
Agency does not necessarily expect that SMPs will impose new
restrictions on every use site or geographic area in which a pesticide
is used in a State; if there is a reasonable basis for determining that
risks for particular use sites or areas are not unreasonable, then
little or no change from current label requirements may be needed.
Prevention measures may overlap with response measures at the point
that pesticide contamination of ground water is detected. For example,
when pesticides are detected, preventive actions can still be pursued
to prevent further contamination. States may choose to combine their
prevention and response discussions because of this overlap.
Appendix B: Assessment, Prevention, Monitoring, and Response
Components of Pesticides State Management Plans of the Guidance
identifies ground-water protection practices and methods for
implementing prevention efforts that States may consider in the
development of their prevention component. The methods described there
are not considered an exclusive list of available options. The Agency
fully expects some States to develop innovative measures to achieve
their ground-water protection goals.
Because of the wide variety of possible approaches a State might
adopt to fit a wide variety of local circumstances, proposed
Sec. 152.190(g) is worded very generally in order not to restrict the
States' flexibility. While EPA is proposing that the rule provide for
maximum flexibility in State program design, it acknowledges that other
approaches are feasible. In recognition of this fact, EPA elsewhere in
this preamble (see section D of this Unit) is requesting public comment
on

[[Page 33271]]

alternative approaches to prevention program requirements.
The relation of these prevention programs to other risk-management
measures will be an important consideration for the States in the
development of SMPs. These SMPs are required to address the ground-
water contamination potential of the five pesticides subject to today's
rule. It happens, however, that these pesticides also represent a well-
documented risk of surface water contamination, at least in some of
their use-areas (see, for example, ``Triazines Water Resources Impact
Analysis'' (Ref. 19)). Thus, an acceptable Plan for these pesticides
must include consideration of whether specific measures employed by a
State to protect ground water might elevate risks to surface water. For
example, a Plan which would change a tillage practice to reduce
pesticide infiltration of ground water may in some instances increase
runoff to surface water. EPA therefore strongly encourages States to
implement measures to protect surface water from pesticide
contamination that is likely to impair water quality. Specifically,
States should coordinate the development of preventive measures with
measures under existing EPA programs, such as the Nonpoint Source,
Coastal Zone Management, Wellhead Protection, and Comprehensive State
Ground Water Protection Programs. Measures must also be coordinated
with the USDA Soil Conservation Service's Compliance Conservation
Plans.
As discussed in Unit IV.B. of this preamble, adverse ecological
effects associated with these compounds are a concern, and a reason for
proposing the compounds for SMPs. Because the ability to identify
ground-water discharge to surface water is limited by resources and the
current state of scientific knowledge, EPA will not disapprove out of
hand any proposed State Plan that fails to specifically address ground
water supporting surface water ecosystems in either the ``basis for
assessment and planning,'' ``monitoring,'' ``prevention,'' or
``response'' components. However, States that are aware of specific
bodies of water that receive a large percentage of their recharge from
ground water are strongly encouraged to attempt to take this fact into
account in designing the above components of their Plans. As in
evaluating the adequacy of any and all the elements of State proposals,
reviewing EPA regional offices will evaluate the adequacy of State
measures to address such ``closely hydrologically connected'' ground
waters on the basis of its own and the State's assessment of the
State's vulnerability in this respect.
Similarly, if a State expects that a risk reduction measure will
lead users to use alternative chemicals, then EPA encourages the State
to consider whether the alternative chemicals will cause adverse
effects to ground water, surface water, other areas of the environment,
or other types of risk, such as risks to pesticide applicators. In
other words, the State, in its Plan, should provide a reasonable
assurance that the preventive measures it proposes to protect ground
water are not likely to result in unreasonable adverse effects
elsewhere in the environment as a consequence.
8. Response to detections of pesticides. This component will
describe how the State plans to respond to contamination to ensure that
reference points (MCLs, HAs, or State quality standards) will not be
reached in ground water, and what actions the State will take in the
event that the reference points are reached or exceeded. Response
measures should be based on the State's ground-water philosophy and the
assessment and monitoring components. Further, this component is
closely tied to the requirements concerning prevention, which specify
that an SMP must describe actions that the State will take initially in
the absence of actual detection and those it will implement if the plan
appears to be failing to protect ground water. SMPs should describe how
the appropriate State agencies will be brought into remedial actions.
Response actions, such as increasing implementation of best
management practices, and use restrictions or prohibitions, are the
focus of this component, rather than remediation activities. Since
FIFRA provides limited means for responding to contamination, however,
States should increase efforts to coordinate enforcement and other
response activities under a number of other Federal/State authorities.
In addition, as in proposed Sec. 152.190(g), States should coordinate
response measures with measures under existing EPA programs, such as
Nonpoint Source, Coastal Zone Management, Wellhead Protection, and
Comprehensive State Ground Water Protection Programs. Appendix B of the
Guidance presents a framework for assessing and responding to ground-
water contamination by pesticides as well as suggested response
alternatives. Again, EPA does not regard the Guidance as providing an
exclusive list of options, since new information becomes available on a
routine basis. For example, EPA is developing new guidance accompanying
its new Hazardous Waste Identification Rule, defining ``best management
practices'' (BMPs) for the treatment of contaminated media at
remediation sites, in order to reduce the potential for cross-media
contamination. Such ``BMP Guidance'' will help States reduce the
possibility of incidental contamination of ground water at remediation
sites. A review draft guidance document has been available since April
1996.
9. Enforcement mechanisms. To meet this requirement, the Plan must
describe the State's enforcement capabilities, authorities, and
compliance activities (e.g., inspections, technical support, penalty
provision, etc.), if not already described pursuant to proposed
Sec. 152.190(c). The SMP also needs to identify the State agency with
each enforcement authority and how coordination of enforcement
capabilities will work to prevent and respond to contamination.
In addition, a Pesticide Plan must discuss the State's enforcement
authorities and capabilities to monitor compliance with the specific
measures included in the SMP, both those intended to protect ground
water from contamination and response actions where contamination has
already occurred. Further discussion of enforcement requirements can be
found on pages 3-18 to 3-19 of the Guidance.
10. Public awareness and participation. Most government activities
are subject to citizen involvement and review. An acceptable Plan must
demonstrate that the public has opportunity to be involved in the
process of Plan development and will be informed of significant Plan
implementation activities. The Plan must address three different
aspects of necessary public awareness and participation. The Plan must:
i. Describe the opportunities for public input regarding
development of the Plan and decision-making in implementing it.
ii. Indicate how, when, and by whom the public will be informed of
detections in ground water that are considered significant.
iii. Include a description of the process and means of
communication by which the public will be made aware of important
regulatory actions taken under the SMP. More discussion of public
participation issues can be found on pages 3-19 to 3-20 of the
Guidance. However, as discussed earlier in this unit, EPA expects that
in fulfilling the first requirement, a State will at a minimum provide
notice and opportunity to comment on whether the SMP under development
satisfies the criteria for SMPs proposed in this rule,

[[Page 33272]]

including an opportunity to assess costs and benefits under the
proposed SMP.
11. Information dissemination. The user is responsible for directly
controlling the use of pesticides in the field. Therefore, an important
part of any SMP must be the means by which ground-water protection
measures and other Plan requirements are communicated to pesticide
users as well as to appropriate industry groups and regulatory
officials (proposed Sec. 152.190(k)). Further discussion of this
requirement is provided in the Guidance (pages 3-20 to 3-21).
12. Records and reporting. Documentation of a State's program not
only serves as a source of data to share with EPA and other involved
Federal and State agencies, but also provides a basis on which to
assess the effectiveness of a State's prevention and response measures.
An adequate SMP discussion of records and reporting will identify both
management measures relating to the State's progress in implementing
the Plan and environmental indicators of the effectiveness of the
program. The Guidance provides a fuller description of the reporting
requirements established by the new Subsection (l), particularly the
key ``Biennial Report'' (pages 3-21 to 3-24). In addition, Chapter 5 of
the Guidance's Appendix A provides a fuller discussion of the Biennial
Report requirements pursuant to the provisions of this proposed rule
for evaluation of EPA-approved Plans.

D. Evaluation of State Management Plan Implementation

Once in place, SMPs are a permanent condition of registration for
the pesticide, for as long as the pesticide remains registered.
Proposed Sec. 152.191 of the new subpart J provides for EPA evaluation
of State implementation of their Plans. Periodic evaluations of the
implementation of SMPs will measure the State's progress towards its
goals and commitments, determine the environmental effectiveness and
the level of ground-water protection provided by the Plan, and ensure a
minimum level of national consistency.
EPA will use the SMP Biennial Report required in proposed
Sec. 152.190(l)(2) to evaluate a State's effectiveness in protecting
its ground-water resources from pesticide contamination. Both the
general provisions for EPA's evaluation of approved SMPs and the
Agency's expectations about the form and content of the Biennial
Reports are described in greater detail in Chapter 5 of Appendix A of
the Guidance. In specifying an evaluation requirement, EPA recognizes
that States have a variety of evaluation methodologies and measures at
their disposal.

E. Amendment of State Management Plans

Once in place, State Management Plans will have considerable built-
in flexibility, in order to respond to a variety of circumstances. For
instance, the response component entails a range of options for
responding to contingencies triggered by pesticide detections in ground
water; new information about pesticide usage patterns; and new
information on ground-water vulnerability, use and value. Consequently,
Plans will probably not need frequent revision and update. If the range
of options in a given Plan turns out not to meet the State's needs,
however, States may need to modify and update plans. States should
consider revising SMPs:
If EPA's periodic evaluation of the SMP determines that
the provisions in a State's SMP are not adequately protecting the
ground-water resource from pesticide contamination.
If the statutory or regulatory framework for SMP
development and implementation changes.
If more comprehensive ground-water vulnerability
assessments, additional monitoring methods, improved prevention
technologies or new information concerning the risks posed by a
pesticide become available and need to be accommodated in order to make
the Plan more effective.
If a State, through experience, finds substantially
different, more effective ways to assess ground-water contamination,
prevent or respond to contamination, or disseminate information.
If changes in crops or crop production systems within the
State are significant enough to require different pesticide management
measures in order to manage risks to ground water.
If roles and responsibilities of State agencies materially
change.
Section 152.193 provides for the modification and update of SMPs
under these circumstances.
Ordinarily, a State will submit needed amendments as part of the
SMP Biennial Report. In an urgent case, a State may appeal for revision
outside the biennial review process to the Regional Administrator. In
addition, if the Regional Lead Office determines through the evaluation
process that the SMP needs to be amended, then the Regional
Administrator can initiate the amendment process by requesting that the
State submit an SMP Update Report. Chapter 6 of the Guidance's Appendix
A describes the process EPA envisions for the modification and update
of approved SMPs.

F. Withdrawal of Approval of a State Management Plan

Section 152.195 of the proposed regulatory text provides for EPA
withdrawal of its approval of existing State Plans under certain
circumstances. Withdrawal of approval can begin when:
The State fails to demonstrate that it is satisfactorily
implementing the SMP as approved.
The State's SMP is not protecting ground water from
contamination above the ground-water reference point.
The State fails to address deficiencies identified in the
SMP Evaluation (per proposed Sec. 152.191), by updating the SMP (per
proposed Sec. 152.193) and/or improving implementation of the SMP.
EPA envisions such revocation of a State's Plan to be generally a
last resort. Before the withdrawal process commences, the State will
have the opportunity to respond to EPA-identified deficiencies in its
Pesticide SMPs through the SMP amendment process or by demonstrating to
the Agency that the SMP is being satisfactorily implemented. Regions
will work closely with individual State agencies or the State Liaison
to assist the State in updating the plan or in addressing deficiencies
or gaps in protection.
Withdrawal of approval of an SMP (as discussed in greater detail in
the Guidance's Appendix A, Chapter 7) is a multi-step process. EPA
would commence the withdrawal process by issuing a formal letter from
the Regional Administrator (acting for the Administrator) to State
officials responsible for implementing the Plan. The notice will
include:
A statement concerning the potential withdrawal of the
SMP.
A listing of the deficiencies of the SMP or a description
of the failure of the Pesticide SMP to protect ground water.
A brief summary of the events that led to the withdrawal
notice, e.g., failure to respond to SMP's deficiencies in the Biennial
Report and failure to update the SMP adequately.
A time frame in which the State can respond to the
deficiencies to stop the withdrawal process e.g., time frames for
submitting an SMP Update Report, for improving implementation of the
plan.
In the event this letter fails to elicit a satisfactory State
response, EPA's next step is a second notice, announcing imminent
publication of a Federal Register notice withdrawing EPA's

[[Page 33273]]

approval of the SMP. In the event this second letter does not elicit a
satisfactory resolution, the final step is publication of a Notice of
Withdrawal in the Federal Register. This withdrawal of EPA's approval
will have the effect of prohibiting the sale and use of the pesticide
in the State. Chapter 7 of the Guidance's Appendix A has a further
description of the Agency and State roles and responsibilities in this
process.
Proposed Sec. 152.195 provides the State the opportunity to respond
to EPA's initial decision to withdraw approval in at least two
different ways. The State may respond in writing to the notice with a
commitment to address the deficiencies in the SMP itself or in SMP
implementation. In this case, the State must respond to the initial
notice within 30 days of receiving it. However, the State may choose to
appeal the EPA decision to initiate withdrawal. In that event, the
State may request a meeting with the Regional Administrator (who will
be the deciding official in these instances); that request must be made
within 60 calendar days of the date of the initial notice. If the State
does not respond to the initial notice within either of these time
frames, or consultations pursuant to the initial notice fail to resolve
EPA's concerns, the Region will take the next step of sending a second
letter, and ultimately, of publishing a Federal Register notice.
In some instances EPA may find an SMP (or its implementation) is so
deficient that further sale and use under its provisions would
constitute an unreasonable risk to the environment. If so, the Regional
Administrator may also prohibit sale and use of the pesticide during
the withdrawal process if, in his or her judgement, continued use of
the pesticide in the State under the conditions of the deficient SMP
presents an unreasonable risk to human health or the environment. In
this event, EPA would propose a temporary prohibition in a Federal
Register notice, in addition to the letters to the States described
above. This notice would explain the Regional Administrator's judgement
that unreasonable risks to the environment may be present during the
time required for correcting the deficiencies in the State's Plan, and
solicit public comment on the impending prohibition. This Federal
Register notice could be published simultaneously with the initial
letter to the State, or at any time after that initial letter, in the
event the Regional Administrator found an unreasonable risk to the
environment was impending. After addressing any public comment, the
Regional Administrator would implement the temporary prohibition. The
prohibition of sale and use would remain in effect until the State and
EPA reach agreement on how to address the SMP's deficiencies.

G. Label Changes

This regulation requires a change to the label of any pesticide
subject to an SMP, so that users will be aware of their responsibility
to use a product in accordance with the provisions and restrictions of
an EPA-approved SMP. All products subject to an SMP must bear the
following statement describing the SMP restriction itself:

For use only in accordance with an EPA-approved State Management
Plan (SMP) for ground-water protection. Sale and use are prohibited
in States that do not have an EPA-approved State Management Plan.

Each State Plan will provide for other means, separate from the product
label, to disseminate to pesticide users specific additional
provisions, management measures and geographic restrictions. These
State-specific information dissemination measures are intrinsic to the
SMP in accordance with Sec. 152.190(k) described above. However,
additional information may be placed elsewhere on the label in order to
direct users to appropriate State sources for more information, or to
describe in more detail SMP requirements. Such information will not
appear in the Restricted Use area of the front label, but preferably
within the Directions for Use portion of the label.
In Sec. 152.185(b) of the new subpart J, EPA proposes that
registrants adhere to the same provisions for label changes,
distribution and sale and advertising as apply to pesticides classified
for conventional restricted use. In addition, registrants of pesticides
classified for SMPs need to submit proposed labels specifying the SMP
classification within 3 months of the effective date of the SMP
provision.
An amended label containing the narrative restriction specified in
this proposed rule must be submitted by each registrant of a product
classified by this proposed rule to be subject to SMPs within 12 months
of the publication of the final rule; and the amended label must be
affixed to all products subject to this classification on the effective
date for the rule.
EPA is proposing in this document to reorganize part 156, the
regulation specifying labeling requirements for pesticides and devices.
Part 156 is now organized so that paragraphs (a) through (j) of
Sec. 156.10 each describe one of nine specific components of a
pesticide product label. EPA proposes that the last two paragraphs of
Sec. 156.10 become a separate subpart. EPA regards these as
particularly important components. Specifically, the Agency is
proposing to amend part 156: (1) By creating a new subpart G to
encompass the existing paragraphs (i) and (j) of Sec. 156.10; (2)
redesignating paragraph (i) as two new sections, Sec. Sec. 156.120 and
156.121, within this new subpart G; and (3) creating new Sec. Sec.
156.135, 156.136 and 156.137 within this subpart G (from the previous
paragraph (j)) to describe labeling pertaining to use classification,
including both conventional restricted use to certified applicators and
restriction to use under approved SMPs. The new label statement to
accompany a product classified for SMPs is specified in the new
proposed Sec. 156.137(c)(2). As proposed, the SMP statement would
appear under the ``Classification'' heading, because legally, an SMP is
a form of classification pursuant to the ``other regulatory
restrictions'' authority in FIFRA section 3(d).

H. Request for Comments

EPA is interested in receiving comments on all aspects of its
proposed 40 CFR part 152 subpart J. For instance, is the effective date
of 33 months after promulgation of the rule appropriate? Does it permit
sufficient time for registrants to make the necessary label changes?
Does it permit States sufficient time to develop Plans and EPA to
review them before the restriction is effective? Does the proposed
development, review and approval process provide sufficient public
opportunity to comment on the contents of the Plan before its approval
and implementation as a regulatory restriction? Has EPA properly
specified the criteria which State Plans must meet? Has EPA provided
sufficient mechanisms for appealing decisions to approve or disapprove
Plans, and for evaluating, amending, and revoking Plans? Is two years a
sufficient interval for EPA to require States to report on their
implementation of SMPs? What further measures could be employed to
encourage States to prepare Plans for pesticides with minor uses within
their boundaries, so as to provide for their appropriate continued use?
Should EPA concurrently develop National datagathering requirements to
be applied to the registrants of the pesticides subject to SMPs, with
the intent of easing States' ground-water monitoring burdens? If so,
how should the Agency design such a requirement, i.e., balancing
between helping the States with their monitoring efforts and not
infringing on States' flexibility and

[[Page 33274]]

power to prescribe its own monitoring regimen? What further national-
level resources (e.g., technical assistance from the USDA's Natural
Resources Conservation Service) should be anticipated for supporting
development of State Plans? Should EPA classify a pesticide for
``conventional'' restricted use classification at the same time it
determines the pesticide must be subject to SMPs, in this or a
subsequent rule? Should EPA propose a new form of labeling for
pesticides classified for SMPs, to distinguish those pesticides from
pesticides classified as ``conventional'' restricted use?
In addition to comments on issues like those described above, the
Agency is interested in receiving comments on alternative approaches to
the specification of State prevention-program components. Within the
general framework of the SMP approach, there are many ways to specify
how States will perform the duties of protecting ground water from
contamination by pesticides. The approach being proposed today is in
conformance with the previously published Guidance, which remains the
Agency's preferred approach. EPA believes the approach developed in the
Guidance provides for maximum flexibility in developing the means of
ground-water protection, within the broad determination by the Agency
that these pesticides warrant additional regulatory restriction. This
flexibility, in turn, maximizes the opportunities for State initiative
and effectiveness in tailoring its ground-water protection efforts.
At the same time, the balance between national consistency and
State flexibility may be struck in numerous other ways, while still
maintaining a fundamental partnership between EPA and the States. The
Agency is pecifically soliciting comment on how to strike this balance,
within the general consensus it believes exists on the existence of
Federal and State roles. For instance, should EPA require an SMP to
include regulatory action to prohibit use of the pesticide under SMPs
in areas where contamination from current, legal use exceeds the
reference point in current or reasonably expected sources of drinking
water? If so, should EPA also require States to complete their
identification of current and reasonably expected sources of drinking
water (if States choose to make such a delineation) prior to Plan
approval?
In addition, EPA is soliciting comment on whether it would be
helpful for the Agency to provide more specific guidance to States (in
the form of technical assistance, new guidance documents or amendments
to the existing Guidance) on particular risk-reduction measures that
may be appropriate to particular indications of present groundwater
contamination. Such guidance would not be prescriptive (that is,
codified in rulemaking), but rather reflect the best experience of EPA
and the States in managing ground-water protection, as the States
develop and implement SMPs. A State and EPA Region could benefit from
the experience of others, with the cumulative effect of all States and
Regions reaching a mutual understanding of what works best in general
situations.
The Agency could be more specific in advance about certain
prerequisites of an adequate SMP. For example, EPA might specify by
regulation different ground-water contamination levels which would
require State response. These levels would be based on the reference
points specified in proposed Sec. 152.198. A State would be free to
specify in its Plan an array of risk-management measures it found
appropriate to respond to such levels of contamination. In contrast,
this regulation as presently fashioned only requires a State to
describe its goals and response program elements in a manner that
allows the Agency to evaluate their adequacy in relation to the
adequacy of the other supporting Plan elements.
Under this alternative, proposed Sec. 152.190(a) would require a
Plan to establish, within its statement of philosophy and goals toward
protecting ground water, its ground-water protection objectives in
terms of EPA's reference point policy. This alternative would also
change proposed Sec. 152.190(h) to require SMP response-program
elements to specify prospective risk-management measures in the event
contamination is detected at or above EPA-specified contamination
levels. For purposes of eliciting comment, EPA offers the following as
appropriate levels: (a) 10 percent of a subject pesticide's ground-
water reference point; (b) 50 percent of the ground-water reference
point; and (c) 100 percent of the ground-water reference point. EPA
would not pre-specify particular risk-management measures for these
levels. However, whatever measures that a State does propose would be
subject to the Agency's evaluation of its adequacy with respect to the
fulfillment of the general objective of ``preventing unreasonable
adverse effects ... and protecting the integrity of the ground-water
resource.''
Such a specification of program performance objectives would be
consistent with the EPA's role under the Federal-State partnership,
that of establishing uniform national policy goals and determining the
overall regulatory approach. At the same time, States would be free to
specify the means of meeting those performance objectives, subject to
Agency review. One benefit of a more concrete specification would be
the avoidance of misunderstandings between EPA and States: EPA would
have stated more clearly what it will find acceptable (or unacceptable)
in defining its requirements in this fashion. Another benefit would be
greater assurance in the adequacy of a State's plan, since an approved
Plan would clearly embrace a risk-management scheme tied to a uniform
set of criteria for action. Regulation would be more protective insofar
as all States would meet a minimum threshold of risk-management
measures. This approach might also facilitate EPA review of Plans, by
eliminating an additional interpretive step, that of determining
whether the State proposal, in its unique form, conforms with EPA's
expectations.
Finally, the Agency recognizes that some potentially affected
parties have expressed concern that the proposed rule does not offer an
opportunity to maintain use of a pesticide in the event a state does
not have an approved SMP, for whatever reason. Therefore the Agency
requests comment on whether there should be a default provision for
stringent federal label requirements and/or conditions on the terms of
registration for these pesticides that would allow continued use in
lieu of an approved SMP.
Under this option, the Agency would specify in the final rule the
national-level requirements that would apply to use of these pesticides
in States without approved SMPs by the effective date. The Agency has
established a model for such requirements. In 1994, the Agency granted
a conditional registration for a new herbicide, acetochlor, for which
the potential for ground water contamination is a concern. In that
case, the Agency imposed a variety of restrictions on the use of
acetochlor, including limiting application to certain soil types,
prohibiting aerial application, and restricting use to certified
applicators. In addition, the Agency required the registrant to conduct
ground-water monitoring at a specified level of effort, and set
triggers that would result in localized use prohibitions, and
ultimately national cancellation of the registration if certain
detection criteria are met. A copy of the specification of the terms
and conditions of registration for pesticides containing acetochlor,
which would

[[Page 33275]]

serve as the model for such specifications in the final rule, is
available in the public docket for this rule. EPA notes that nothing in
this proposal would preclude registrants themselves from proposing
additional restrictions on the use of their product to the Agency,
pursuant to FIFRA section 3(c)(5), in the event a State chose not to
adopt an SMP. Consequently, this proposal leaves open to registrants
the option of themselves devising suitable restrictions to prevent
unreasonable adverse effects on the environment from use of these
pesticides in the unlikely event that a State chooses not to develop an
SMP, or that no SMP is approved.
The Agency would like comments on the following. Would a similar
approach be appropriate for the SMP chemicals in the event a State
elected not to develop an SMP for one or more of the chemicals? Should
the default be available if a State did submit an SMP, but EPA did not
approve it? What specific precautions and limitations on the label
would provide adequate protection of ground water in the absence of an
SMP? Is the Agency correct in proposing to use the specifications of
the acetochlor registration as the basis of such national-level
defaults, or are there specific provisions to be added or deleted?
Should registrants be required to conduct monitoring, and if so, to
what extent? If there is a registrant monitoring program, should States
have a role in determining where and how monitoring is carried out?
Should there be triggers for use prohibition in a State, or only in a
local use area; if so, what should they be? What would the impact of
this Federal alternative be on registrants and users? What would the
effect of this alternative be on State development of SMPs and other
ground water protection activities or programs?

IV. Risk and Benefit Determination

A. Chemical Background and Characteristics

1. Uses. The five candidates for SMPs proposed today are similar in
many important respects. All five are broad-spectrum herbicides
registered for use on a total of 100 different crops, including most of
the major field crops grown in the United States (e.g., corn, sorghum,
and wheat). Together, the five compounds are registered for another 31
non-crop and non-food uses including ornamental tree, plant, and grass
sites. Atrazine, simazine and cyanazine are members of the s-triazine
family of compounds, and are each used to control a variety of
broadleaf weeds and grasses. Each is used for preplant, preemergence
and postemergence weed control in crops. Alachlor and metolachlor are
acetanilide compounds registered for pre-emergent control of broadleaf
weeds and grasses.
EPA estimates that between 200 and 250 million pounds of the five
herbicides, together, are used annually in the United States, which
represents as much as one-half of total annual agricultural use of
herbicides. Atrazine, alachlor, and metolachlor are currently ranked as
the three highest-volume pesticides in use in the United States today,
with cyanazine ranked fifth. Approximately 150 to 160 million pounds of
active ingredient (a.i.) of these four pesticides are applied to just
two field crops: corn and sorghum. Alachlor and metolachlor are also
commonly applied to soybeans, with 20 to 30 percent of their annual use
attributable to this crop. Remaining uses of these four herbicides,
while representing a small fraction of their combined use, still
represent several million pounds of active ingredient. For example, 1
to 2 million pounds of cyanazine are used annually on cotton; also,
another substantial use of atrazine is on sugar cane.
Historically, use of atrazine was marked by a rapid rise in use on
row crops through the 1960's, joined by a similar sharp rise in
alachlor use from 1969 to 1974. At that time, use volumes of each
leveled off at comparatively high levels (e.g., about 80 million pounds
annually) as use of cyanazine, and then metolachlor, climbed. Through
the 1980's, use volumes began to fluctuate, with use of the two older
chemicals drifting down from combined uses of 170 to 190 million pounds
per year to levels of 120 to 150 million pounds per year. These general
declines were matched by corresponding increases in the other two.
During the first half of this decade, this general trend continues,
with the exception of a relatively sharp decline in alachlor, and a
slightly earlier, but more-than-offsetting increase in metolachlor use.
Simazine stands as the exception to the rest of the candidates with
respect to use. Only 3 to 5 million pounds of active ingredient are
used in the United States annually. However, 1 to 2 million pounds (31
to 42 percent) of simazine is applied to corn, making it the principal
use of simazine as well. Simazine's remaining uses include crops such
as alfalfa, seed crops, fruits (apples, citrus, grapes, berries and
stone fruits, among others) nuts and vegetables. Simazine is also
registered for several terrestrial non-agricultural uses, as well as
for aquatic uses (i.e., ornamental ponds).
2. Other regulatory actions. All five pesticides are subject to the
reregistration requirements of the 1988 FIFRA Amendments.
Reregistration of existing pesticide products entails the determination
that they are eligible for reregistration because: (a) The data
necessary to determine the pesticide's risk are substantially complete;
and (b) these data indicate that the pesticide does not cause
unreasonable adverse effects when the products are used according to
label directions and restrictions. EPA publishes Reregistration
Eligibility Documents (REDs), which summarize the studies reviewed and
the findings reached. A RED for metolachlor has already been published
(EPA 738-R-95-006, April 1995); a RED for alachlor is scheduled to be
published in 1996. REDs for the three triazines are not expected before
the conclusion of the triazines special review.
In addition to the scheduled reregistrations, four of these
pesticides are in Special Review. One, alachlor, has been under Special
Review since 1985. While EPA resolved substantial risk concerns about
the use of alachlor in 1987, the Agency deferred action on whether the
risks posed from alachlor in drinking water from contamination of
ground water required regulatory action. EPA proposes to conclude
review on these issues with the promulgation of this rule.
In November 1994, the Agency initiated Special Review (59 FR 60412,
November 23, 1994) of the three triazine compounds - atrazine, simazine
and cyanazine - subject to this rule. The Review will address the
potential overall risks to human health and the environment posed by
use of these three pesticides, particularly the carcinogenic risks from
human exposure in drinking water, food, and through handling and
application of products. Ground-water contamination is part of the
concern in conducting the Special Review, but only part of the broader
concerns addressed by it. Therefore, the Agency believes it is
appropriate to carry out both regulatory proceedings for the triazines
at this time.

B. Risk Assessment

1. Adverse health effects-- a. Toxicological endpoints of concern.
Toxicological endpoints of concern for these five compounds (and their
metabolites) include carcinogenicity (all five compounds),
developmental toxicity (atrazine and cyanazine), chronic blood and
organ toxicity (cyanazine, simazine, alachlor, and metolachlor), and
cardiotoxicity (atrazine). In the following discussion,

[[Page 33276]]

atrazine, simazine, and cyanazine are frequently referred to together
as triazines, when the three compounds exhibit similar characteristics
and effects.
EPA's Integrated Risk Information System (IRIS) summarizes the
available information on the toxicological endpoints of concern for the
five pesticides in today's proposed rule. IRIS data are available to
the public in both printed and on-line form, and can be accessed by
telephoning IRIS User Support at EPA's Center for Environmental
Research Information in Cincinnati, Ohio; (513) 569-7254. The
discussion below does not include a detailed review of studies showing
relatively minor adverse effects, such as changes in average body
weight or the rate of weight gain in developing animals. More extensive
discussion of the evidence of adverse health effects for each of these
pesticides has been presented in other documents, e.g., for
metolachlor, in the recent Reregistration Eligibility Decision document
and for the triazines, in the Federal Register notice announcing the
initiation of the triazines Special Review. A more complete description
of the toxicological evidence to support this rulemaking, drawn from
these existing sources, is provided in the docket for this regulation.
All five compounds exhibit adverse effects in animals after long-
term exposure, raising concern about chronic toxicity. For example,
long-term (usually 2-years) feeding studies with the triazines
typically show reduced rates of weight gain, and in some cases,
hematological effects, such as reduced red-cell count. Treatment of
pregnant animals with all of these compounds shows some developmental
effects, such as reduced weight gain, or reduced litter size. In
addition, a 1-year dog study with atrazine showed cardiac effects such
as increased heart rate and irregular heartbeat. Although these are all
adverse effects, they do not present the same level of concern as the
evidence of cancer risk.
EPA had classified atrazine, simazine, cyanazine and metolachlor as
Group C (possible human) carcinogens. EPA's Office of Pesticide
Programs has assigned a numerical cancer potency coefficient, known as
a Q1*, to each of these chemicals as well (see Table 2 below).
The triazine compounds have an extremely close structural
similarity and produce similar tumor profiles in animal bioassays,
primarily malignant mammary tumors in female rats. In addition to
animal study data, EPA has reviewed a number of epidemiology studies
which s

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A96-16173. Public record. Not legal advice.